Poster session A

Trial searching, Registers and The Cochrane Library

[P1] From Handsearch to The Cochrane Library: Encouraging the Conversion of Previously Published Meta-Analyses and Systematic Reviews to Cochrane Format.

Marta Roqué, Josep Maria Garcia, Meritxell Rigola. Iberoamerican Cochrane Center, Barcelona, Spain.

Objectives: 1. To develop and test an initiative to promote the conversion of previously published Spanish meta-analyses and reviews to Cochrane format. 2. To increase the production of new Cochrane reviews in Spain. Secondary objectives: 1. To identify reasons for authors not wanting to convert their review into Cochrane format, and to propose possible solutions. 2. To identify the difficulties arising during the conversion process, and to propose possible solutions.

Methods: From the 50 meta-analyses identified through handsearch of Spanish journals of Internal Medicine for the years 1948-1998, two independent reviewers will select papers suitable for conversion into a Cochrane review. Selection criteria will be: 1) A systematic review has to address a health intervention related to therapy or prevention. 2) The review should not be already registered or in course of development in the CC (http://www.cochrane.no/titles/ and CL Issue 2/2002). Authors of the meta-analyses will be contacted by electronic mail, postal mail or telephone. If necessary, we will explain what the CC is and how it works, and we'll encourage them to convert their work into Cochrane format.

We will explain the required steps in developing a review, puting emphasis on the commitment to update the review. The authors who agree to do the conversion will be put in contact with the corresponding CRG and they will receive the training and support usually provided to iberoamerican reviewers: Spanish translation of Handbook, web-based course on review, attendance at a workhop on systematic reviews, and a personalized follow-up by mail or telephone. During the converting process, we will record the difficulties and problems that may arise, as well as the solutions found. The authors that refuse to convert their review will be asked about their reasons and further encouragement will be provided if appropriate.

Results: We have performed a pilot test with 3 meta-analyses chosen at random: one of them was not related to therapy (Baile 1999), the main author of the second didn't reply (Mendarte 2000) and the third one is currently being converted into a Cochrane review (Sanchez-Manuel 2001, protocol currently under editorial referee). When the poster is presented at Stavanger Colloquium, complete results derived from the 50 studies will be available.

Conclusions: Possible benefits: To generate a new Cochrane review at a minimum cost; to disseminate and apply the philosophy of no duplication of efforts; to interest researchers in the geographic area of the CCIb and to get to know the CCIb as a source of help and services to researchers. Possible challenges : This initiative arises from an expanded handsearching process, which is not found on all Centres; the whole process requires a moderate time and effort investment from the Centre, and it requires the stablishment -if they don't exist already- of mechanisms to offer suport to local reviewers.

References

• Baile A, Asua J, Albisu A. Hiperplasia benigna de próstata. Variabilidad de práctica y guía de actuación basada en la evidencia científica. Atención Primaria 1999; 23(3): 142-50
• Mendarte L. Meta-analyses of granisetron versus ondansetron: efficacy and safety in the prevention of acute emesis induced by high dose cisplatin containing schedules. Med Clin 2000; 115(12):456-60
• Sanchez Manuel FJ, Seco-Gil JL, Lozano-García J. Profilaxis antibiótica y reparación herniaria. Resultado de una revisión sistemática cuantitativa. Enferm Infecc Microbiol Clin 2001; 19:107-13

[P2] How Important is the Size of a Reprint Order?

Sally Hopewell, Mike Clarke. The UK Cochrane Centre, Oxford, United Kingdom.

Objective: The number of reprints ordered for some journal articles can be very large. One measure of the importance of these articles is the number of times they are cited. This study aims to assess the impact of articles with very high reprint orders (‘high-reprint articles’) by measuring their citation in the subsequent literature as compared to a control group of articles.

Methods: The 21 articles published in the Lancet in 1998 with reprint orders of over 10,000 (information provided by the Lancet) were matched with a control set of 21 articles with smaller reprint orders, drawn from the same section and issue of the journal. The Science Citation Index was used to obtain the number of citations for each of the 42 articles.

Results: The 21 high-reprint articles were cited 2548 times; the mean number of citations was 121 (range 3 to 499 citations per article). Five of the 21 high-reprint articles had more than 200 citations, but seven (33%) were cited 25 times or fewer. The 21 control articles were cited 986 times; the mean number of citations was 47 (range 1 to 165). Fifteen (71%) of the 21 control articles were cited 25 times or fewer. Thirteen of the high-reprint articles were reports of randomized trials with a mean of 163 citations. In the control articles, six were reports of randomized trials with a mean of 88 citations.

Conclusions: Articles with a high-reprint order were cited more frequently than other articles. However, some high-reprint articles were cited infrequently. If the size of a reprint order is related to the importance of an article, those articles with very high reprint orders are, or become, more important. Possible explanations for the relationship between the number of reprints and the number of citations will be explored in the presentation.

[P3] A Register of Methodological Research

Sally Hopewell, Mike Clarke, Kirsty Loudon Olsen, Andy Oxman. The UK Cochrane Centre, Oxford, United Kingdom.

Over the last few decades, the problems in identifying relevant trials of health care interventions have been described many times. Publication bias and selective reporting of trial results make the task of finding trials extremely difficult. Trying to overcome this problem has been one of the major tasks undertaken within the Cochrane Collaboration. The preferred solution, however, is the prospective registration of all clinical trials and there are now several initiatives to help achieve this aim.

We need to learn from this within methodological research. We should prospectively register our own empirical studies. This would both facilitate future systematic reviews of methodology (as conducted by the Cochrane Methodology Review Group) and allow users of the individual studies to identify them more easily. To succeed it must be easy both to input and to extract information.

Currently, the Cochrane Methodology Register in The Cochrane Library contains records for published reports of empirical studies of methodological aspects of systematic reviews. In addition, some Cochrane Methods Groups maintain details of ongoing research relevant to their scope (for example, the Individual Patient Data Methods Group). Combining these might, therefore, be a solution for the short term. In the longer term, a prospective register (as currently piloted within the Cochrane Methodology Register) of all ongoing methodological research is required. Information on ongoing methodological research is being collected including the name and contact details of the researcher, the study title, start and finish date, the study objectives, the source of data, proposed analyses and plans for dissemination of the research findings. Eventually, a structured report of the findings of each study will also be included. In order to succeed, it is important that all individuals be encouraged to register their research prospectively.

[P4] Coding Scheme for the Cochrane Consumers and Communication Review Group (CCCRG) Specialised Register

Judy Stoelwinder, Sophie Hill, with assistance from Sandy Oliver, Dominique Broclain, Michel Wensing, Lucy Brewer, CCCRG, School of Public Health, LaTrobe University, Melbourne, Australia

Objective: To develop a method of coding the trials in the CCCRG Specialised Register in relation to the scope of the Group, the interventions undertaken and the outcome measures used.

Methods: An alphanumeric coding scheme was developed to facilitate the coding and analysis of the 2545 trials in the Procite database. The coding scheme was pilot tested on 50 trials, revised, tested independently on another 25 trials, then re-tested on a further 50 trials, before a final version was agreed. Selection of concepts and terms to include in the coding was made from the Group’s scope and the interventions and outcomes of interest to the Group, from knowledge of the subject range of the trials in the register, and from the interventions and outcomes listed in relevant systematic reviews. Whilst there are five broad areas of the Group’s scope, there are a wide range of types of communication based interventions and outcome measures.  This meant the various expressions for the same concepts were grouped to facilitate coding and analysis. Alphanumeric codes were allocated in a format to facilitate searching and counting the number of trials indexed by particular concepts and to allow for insertion of additional terms and adjustments to the scheme. Each trial may be coded for more than one scope area, intervention or outcome measure.

Results: Trials in the register may now be coded by the broad scope areas; by the intervention,  indicating direction of the communication between health provider and consumer, by the type of communication strategy, the setting of the intervention, and the communication medium used; and by the outcomes as consumer oriented, health care provider oriented or health service delivery oriented. A further level of coding is used to provide more detailed analysis of the interventions and outcomes. For example, under the broad heading of  Consumer oriented outcomes (Code:N) there are nine groupings of outcomes. One of these is  Health status and wellbeing (Code: N7), with the more detailed coding to the level of Physical health (Code: N7g), Psychological health (Code: N7m) and Psychosocial outcomes (Code: N7q). Counting the number of trials in the register that are relevant to particular areas of the scope or by particular intervention or outcome is possible by searching by the alphanumeric code to the level required. This project commenced in October 2001, and as of 6 March 2002, 814 trials have been coded.

Conclusions: The coding scheme that we have developed will serve the purpose of:

• identifying and coding interventions and outcomes from studies that are relevant to our Group,
• provide a means for input to the analysis of the studies in our register,
• using the grouping of terms when searching for studies with particular types of interventions or outcome measures in addition to the usual searching by free text or thesaurus terms,
• provide a checklist of outcomes that reviewers may need to consider,
• help with gap analysis of the current reviews,
• assist with the planning and prioritizing of future reviews.

[P5] Analysis of the Trials on the Cochrane Consumers and Communication Review Group (CCCRG) Specialised Register

Judy Stoelwinder, Sophie Hill, Sandy Oliver, CCCRG, School of Public Health, LaTrobe University, Melbourne, Australia

Objective: To describe the focus of randomised and controlled clinical trials addressing consumers and communication.

Methods:. An alphanumeric coding scheme was used to facilitate the coding and analysis of the 2545 trials in the Specialised Register which consists predominantly of relevant trials identified and retrieved from the Cochrane Controlled Trials Register. Coding commenced in January 02, with each trial coded by the scope, intervention and outcome, with most trials having more than one category for intervention or outcome.  Data on the number of trials coded for each of the scope, interventions or outcomes was compiled after searching for the appropriate alphanumeric code in the relevant Procite field.

Results: By 14 Feb 02, the first 598 trials in the Register had been coded. The new coding system enabled us to identify the proportion of trials by existing scope areas:

• Communication enhancement (19%)
• Health care decision making which includes education and support of the patient (76%)
• Participation in health care planning, policy and research (5%)
• Communication techniques and media (27%)
• Placebo effects (<1%)

Other major features of the Register are:

Interventions:

a) Direction of communication:  the majority of communication interventions are directed to the consumer by the health care provider as patient education (48%), skills training (21%) or counseling (15%).

b) Interventions where the direction of communication is between consumers strongly favour provider-led or initiated group activities (10%), or family support (8%), compared with self help groups (2%).

c) Setting of the intervention: one third of interventions are hospital based, one fifth take place in the patient’s home, and nearly half of the studies were undertaken in the USA.

Outcomes: 

a) Most outcome measures related to health behavior, particularly “compliance” (35%) or measured the patient’s psychological health (28%).

b) Knowledge acquisition and retention of information by consumers were measured as outcomes in one third of trials.

Conclusions: The new coding system has immediate benefits in analyzing the Register and identifying gaps in research. This analysis revealed a widely held ‘deficit’ model in consumer-provider communication, whereby the aim is to increase consumers’ knowledge and compliance in order to improve their health and well being. Conversely, little attention is paid to the possibility that health care providers may learn from consumers during clinical consultations or by working with them in planning services, policy or research. Where attention is paid to communication from consumers to providers it is set in a provider centred framework of inviting feedback, history taking or patient profiling (usually highly structured by the provider) or the consumer asking questions. A consumer focused agenda for trials would give greater priority to providers listening (not just history taking or responding to questions) and learning from consumers. The small number of trials of consumer participation in health care planning, policy and research probably reflects less enthusiasm for trialists in this area, which faces political and methodological challenges. Until these are overcome, doubts about the value and methods will continue.

[P6] Obtaining Published Errata to Randomised Controlled Trials: Is it Worth the Effort?

Pamela Royle, Wessex Institute for Health Research and Development, University of Southampton, Southampton, United Kingdom.

Objective: To do a pilot study to determine the frequency and nature of published errata linked to RCTs in the MEDLINE database, and to estimate the proportion that are worthwhile obtaining.

Methods: MEDLINE (SilverPlatter) was searched from 1995-2001/06 for records that had both ‘randomized-controlled-trial’ in the publication type field and ‘erratum’ in the comments field. (When a citable correction is published for an article that has a citation in MEDLINE, a reference to the published correction is added). Records from four journals (Lancet, BMJ, New England Journal of Medicine and JAMA) were downloaded, and 100 were randomly selected. The full articles and errata of the 100 records were examined by the author and assigned to one of three categories: 1. Yes - worthwhile acquiring, 2. Maybe – possibly worthwhile, 3. No - not worthwhile.

Also investigated were the number of errors mentioned per published erratum, the number of citations to the RCT and their erratum in the Science Citation Index, the time between publication RCTs and errata, and indexing of the errata in the Cochrane Controlled Trials Register (CCTR).

Results: The 666 errata to RCTs were published in 295 different journals. 130 errata (19.5%) were published in just four journals; Lancet, BMJ, NEJM and JAMA. The average percentage of RCTs assigned errata was 1.2% over all journals, but 7.8% for these four journals. All RCTs and errata were in CCTR, but 77% of RCTs had one or more duplicate records in CCTR without the errata information. The Lancet, BMJ, NEJM and JAMA all provided free electronic access to errata, but many other journals did not.

The classification of errata gave:

1. Yes = 74%. Mostly in tables or figures.

2. Maybe = 9%. Mostly in the introduction or discussion.

3. No = 17%. Mostly errors in authorship.

Table 1. Characteristics of RCTs and errata

Conclusions: Errata were published for about 8% of RCTs in four major general medical journals, and most (74%) appeared to contain information important enough to be worthwhile obtaining. However, as most errata were never cited, this suggested they were largely ignored. To increase their visibility and access, it is recommended all journals provide free electronic access to errata and that the duplicate RCTs without errata information be removed from CCTR. This should facilitate access to more complete and accurate data for those using RCTs.

[P7] Preliminary Report on Hand Searching Results of 15 Chinese Dental Journals from the Earliest First Volume of 1953 to the Volumes of 2000

Zongdao Shi, Chunlan Guo, E Chen, Wenlang Zhang, Fang Xia, Lei Chen. Oral Group of West China Stomatological Hospital, Sichuan University, Chinese Cochrane Center, Chengdu, P.R.China

Objective: To hand search all formally published articles on randomized controlled clinical trials (RCT) and controlled clinical trials (CCT) for inputting into the database of Chinese Cochrane Center (CCC) and the Central Database of International Cochrane Collaboration.

Methods: All Chinese dental journals of the mainland of China starting publication before the end of 1996 were included for hand searching page by page. Criteria of RCT and CCT were based on the guideline of Cochrane Oral Health Group. All included articles were copied and the titles of the articles and names of the journals were translated into English and input to Procite for submission. A senior professional monitored the process and checked the translation item by item.

Results: Fifteen dental journals were included. One started from 1953, six from 80s, and the rest from 90s. Ten of them were listed by Ministry of Science and Technology as part of the government database for scientific articles. From 1953 to 1990, 42 RCTs and 97 CCTs were found in 291 journal issues, from 1991-1995 157 RCTs and 154 CCTs in 241 issues, from 1996-2000 358 RCTs and 264 CCTs in 316 issues. In the three time period, the average RCTs per journal issue were 0.14, 0.65, 1.13 respectively, the averages of CCTs per issue were 0.33, 0.64, 0.84 respectively. The ratios of RCT to CCT are 0.43, 1.02, 1.36 respectively in the three periods which showed greatly increasing along the time line. There are 113 articles accounting 10.54% of the total specially for testing the effect of various Chinese traditional medicines and therapies. The common weakness for the searched RCTs and CCTs are small sample size, insufficient descriptions on randomization and concealment methods, compliance and drop outs. Some titles were improperly written such as using trade name of drugs etc. In translation into English, some words indicating category or main components of the drugs were added. 

Conclusions: In comparison of one fourth of the world population and more  than 30 thousands dental professionals of China, 557 RCTs and 515 CCTs in dental literature are quite small number but the increasing speed is encouraging. More effort should be offered to spread knowledge of evidence based medicine (EBM) to the dental care workers of China to produce more evidences for the whole world. RCT and/or CCT should be good tools to determining real effects of traditional Chinese medicines in dental fields to make them applicable to all. 

[P8] Organizing Volunteers in the Students of Medical College for Establishing the Database of Clinical RCT, CCT and Diagnostic Tests in China

Li He,  Youping Li,  Maoling Wei,  Mingming Zhang,  Li Wang , 

Chinese Cochrane Center, West China Hospital, Sichuan University

Chengdu, 61004, P. R. China

Objective: To organize volunteers in the students of medical college for establishing the database of clinical RCT, CCT and diagnostic tests in China, thereby promote the establishing of database of Chinese Cochrane Center and the education of EBM in China.

Methods: 

• Giving lecture to the students of medical college in Sichuan university and let them know the importance of EBM and the significance of establishing the database of clinical RCT, CCT and diagnostic tests in China.
• Students who will be the volunteer register in the Chinese Cochrane Center after the lecture.
• The trial search coordinator of Chinese Cochrane Center interviews the students and make decision.
• The volunteers start the work in Chinese Cochrane Center and different department after training during their summer vacation. 

Results:

• 30 students involving in the work of establishing the database of clinical RCT, CCT and diagnostic tests as the volunteer from July 10, 2001 to August 20,2001.
• Their works promoted the establishing of database of Chinese Cochrane Center significantly.

The amount of RCT, CCT and diagnostic in the database of Chinese Cochrane    Center

                                    before Aug. 2001                         after Aug. 2001

                    4000                                                10000

• More students of medical college receive the education of EBM and have a good background for their clinical practice. One of them has completed a protocol of SR. 5 students will publish papers on different journals as the co-author.

Conclusion: Organizing volunteers in the students of medical college for establishing the database of clinical RCT, CCT and diagnostic tests is fit for the condition of China. It could promote the establishing of database of Chinese Cochrane Center and the education of EBM in China.

[P9] Reporting of the Search for Studies, the Format of Study Identifiers, and the Format of References in Cochrane Reviews

Steve McDonald, Australasian Cochrane Centre, Melbourne, Australia

Background: The Cochrane Reviewers’ Handbook and the Style Guidelines for Cochrane Reviews include guidance to reviewers on the reporting of the search for studies, the format of study identifiers, and the format of references.

Objectives: To compare the reporting of the search for studies, the format of study identifiers, and the format of references in new reviews published in issue 3 2001 with new reviews published in issue 2 2002.

Methods: Using a descriptive analysis approach, the following components of all new reviews in issue 3 2001 were assessed against the guidance to reviewers in the Handbook and Style Guide: reporting of the search for studies (abstract and text of review), the format of study identifiers, and the format of references.  Feedback on individual reviews was passed to the relevant review group, with overall findings disseminated to all review groups.  This exercise will be repeated for new reviews published in issue 2 2002.

Results: 66 new reviews from 34 review groups were published in issue 3 2001.  In reporting the search for studies, 30 reviews (45%) failed to provide any mention in the abstract of the date when the searches were conducted. Approximately half the reviews listed the search terms used in the various databases, and a quarter provided at least one full search strategy.  The remaining reviews did not list any search terms.  The majority of reviews (75%) used the recommended format for constructing the study and reference identifiers.  Half the reviews used the full journal name in the references, but in nearly a third of reviews (30%) there was a mix of both full and abbreviated journal names.  Use of the symbol to denote the major publication for an included study was applied inconsistently.

Conclusions: The first stage of this exercise showed several areas where the consistency of reviews could be improved, and highlighted deficiencies and/or confusion in the current guidance to reviewers.  Some of these issues are now being addressed.  The second stage will reveal the extent to which review groups have adopted the feedback and improved these aspects of review quality.

[P10] Development of an Optimal Search Strategy for Finding Trials Demonstrating ACE Inhibitor Blood Pressure Lowering Efficacy 

Balraj S Heran and James M Wright. University of British Columbia, Vancouver, Canada

Objectives: Since its introduction in 1994, the search strategy recommended by the Cochrane Collaboration  (Cochrane highly sensitive search strategy) has been adopted for use by many reviewers for the retrieval of controlled trials from Medline using Ovid and SilverPlatter.  Our objective was to evaluate whether a modified and expanded form of the Cochrane highly sensitive search strategy would identify additional RCTs in Medline that would meet the pre-specified inclusion criteria of our systematic review of the dose-related blood pressure lowering efficacy of ACE inhibitors in the treatment of primary hypertension.

Methods:  A modified search strategy was developed based on the Cochrane highly sensitive search strategy.  Both the original and modified form of the search strategy were implemented for the retrieval of RCTs from Medline using OVID.  The number of RCTs retrieved that met the pre-specified inclusion criteria of our systematic review was compared between the Cochrane highly sensitive search strategy and the modified search strategy.

Results:  The Cochrane highly sensitive search strategy identified 1361 references.  The modified search strategy identified 1606 references.  At the present time, of the additional 245 references identified by the modified search strategy, at least 5 additional RCTs have met our inclusion criteria and will be included in the systematic review. 

Conclusions:  Consistent with the Cochrane Reviewer’s Handbook, increasing the comprehensiveness of our search has resulted in reduced precision.  However, compared with Cochrane high sensitivity search strategy, our modified search strategy has identified at least 5 additional RCTs that have satisfied all criteria for inclusion in our systematic review.  The additional data from these 5 trials will allow for a more precise estimate of the dose-related blood pressure lowering efficacy of ACE inhibitors in the treatment of primary hypertension.  The modified search strategy will also be tested in four additional systematic reviews that are currently being conducted to quantify the dose-related blood pressure lowering efficacy of angiotensin receptor blockers, calcium channel blockers, beta blockers, and alpha blockers.

[P11] Designing an Efficient and Precise Search Strategy for Observational Studies

Susan Wieland, Suzanne Brodney, Kay Dickersin, adresse oppNew England Cochrane Center, Brown University, Providence RI, USA

Objective:  To describe the construction, sensitivity and precision of a maximally sensitive MEDLINE search for observational studies of a relationship between an exposure and disease. Productive search design strategies have been developed for identifying randomized controlled trials for systematic reviews, but precise searches for identification of relevant studies for reviews of observational studies have not been as widely documented.

Methods:  Beginning with a gold standard of all relevant observational studies on breast cancer and oral contraceptives, we used an iterative process to construct a maximally sensitive MEDLINE search strategy.  The gold standard comprised 58 observational studies published between 1966 and 1995 in MEDLINE-indexed journals that were cited in a 1996 systematic review of oral contraceptives and breast cancer.  We examined the MEDLINE record of each study for abstract and title words and Medical Subject Heading (MeSH) for exposure, outcome, and methodological terms.  We designed a search using the minimum number of text words to retrieve all records, and ran a text word search of MEDLINE in PubMed with and without “automatic term mapping” to MeSH.  We then designed a search using the minimum number of MeSH terms to retrieve all records, and ran a MeSH search of MEDLINE in PubMed with and without the automatic inclusion of more specific terms.  The main outcomes were sensitivity (the proportion of the observational studies in the gold standard identified by the search) and precision (proportion of publications retrieved by the MEDLINE search that were also included in the gold standard).

Results:  All 58 records were indexed under MeSH terms human [mh] and publication type [pt] journal article in MEDLINE.  One of the 58 records was not indexed under MeSH female [mh].  We thus limited all subsequent MEDLINE searches to human [mh] and journal article [pt].  Ten of the 58 records (17.2%) did not contain text or MeSH terms related to oral contraceptives, estrogens, or hormone use.  A text word search without “automatic term mapping” retrieved 2,197 records (precision=2.2%, [48/2197]), which included 48 of the 58 gold standard records (sensitivity=83.0%, [48/58]).  A text word search with “automatic term mapping” retrieved 2,920 records (precision=1.6%, [48/2920]), which included the same 48 records (sensitivity=83.0%, [48/58]).  A MeSH search, which allowed explosion of MeSH terms, retrieved 795 records (precision=6.0%, [48/795]), again identifying the same 48 records (sensitivity=83.0%, [48/58]).  Finally, a search using major MeSH terms without the automatic inclusion of more specific terms, retrieved 364 records (precision=13.2%, [48/364]), but included only 28 of the 58 records (sensitivity=48.3%, [28/58]).

Conclusions:  A MeSH search with automatic inclusion of more specific MeSH terms is both the most precise and maximally sensitive.  Further refinement of the MeSH search is warranted, followed by testing in other exposure and outcome areas that may allow development of generalizable search strategies for observational studies.

[P12] A Method for Maximising Comprehensiveness in Systematic Searches, and the Utility of this Approach for the Cochrane Health Promotion and Public Health Field

J. Kavanagh, Ginny Brunton, Angela Harden, Rebecca Rees, Sandy Oliver and Ann Oakley. EPPI-Centre, Social Science Research Unit, Institute of Education, London, Great Britain

Objectives: To measure the impact on comprehensiveness of searching specialised registers when              searching systematically for evidence to support reviews of health promotion interventions. To describe the impact of this strategy upon the specialised register BiblioMap.

Background:The EPPI-Centre is joint convenor of the Cochrane Health Promotion and Public Health Field. It compiles and maintains BiblioMap, a database of bibliographic references of health promotion-related literature. All BiblioMap records have been retrieved from a systematic search and coding strategy (“mapping”), developed by the EPPI-Centre, and conducted as a preliminary stage of all systematic reviews in the EPPI-Centre. This paper will first analyse elements of the search strategies for two systematic reviews in progress, and then describe the contribution BiblioMap has made to the Cochrane Health Promotion and Public Health Field.

Methods:No one electronic database comprehensively catalogues research relevant to the multi-disciplinary field of health promotion. Two ongoing systematic reviews of the barriers and facilitators to healthy eating and physical activity in children required systematic searches to identify diverse types of evidence; outcome evaluations of health promotion interventions; observational studies; and systematic reviews. To maximise comprehensiveness we conducted searches of major databases (MEDLINE, Embase, CINAHL, ERIC, SSCI and PsychLit) in a number of disciplines (biomedicine, social science and education) and specialised registers (BiblioMap, DARE, HealthPromis, the Cochrane Controlled Trials Register, the Cochrane Heart Group register, and HEBS). A strategy combining three conceptual components (children; barriers and facilitators of health promotion; and healthy eating or physical activity) was devised in MEDLINE and translated to other databases. Methodological filters for study design were not used as these reduce the sensitivity of searches.

These search methods have been developed at the EPPI-Centre since 1996.All topic relevant references located by this method have been entered onto BiblioMap and coded using a standardised keywording strategy including research design.Coding allows the retrieval of references to RCTs and CCTs, for eventual submission to the Cochrane Controlled Trials Register (CCTR).

Results:This strategy for the two reviews in progress retrieved 19,023 abstracts and citations, reduced to 1,524 after preliminary screening for relevance. 17% of studies included at preliminary screening were retrieved from specialised registers alone.

BiblioMap currently contains 9,577 references of which 873 (8.9%) were only found on specialised registers. Since January 2001 the EPPI-Centre has submitted 1072 records to the CCTR, and work is in progress for the next submission in March 2002. BiblioMap will be updated with references found from the current reviews

Conclusions: Omitting methodological filters for study design retrieves all study types without compromising sensitivity. Utilising specialised registers maximises comprehensiveness, with less complex searches required due to the specificity of the contents. This method may improve the comprehensiveness of searches for systematic reviews of other multi-disciplinary health topics and may be of particular use to other Cochrane Fields in supporting reviewers within their field.

[P13] To Identify Chinese Trial Reports of Studies: Hand Searching Compare with Electronic Searching

Maoling Wei, Jianping Liu, Ming Liu, Kegang Deng, Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, Sichuan, P.R.China

Objective: One important aim of Chinese Cochrane Centre is to establish Chinese clinical studies  database with two methods: one is hand searching, another is electronic searching. We compared with the two methods to obtain the baseline data for complete Chinese database.

Methods: We selected two journals which are Chinese Journal of Infectious Diseases & Chinese Journal of Integrated Traditional and Western Medicine. According to the criteria for registering studies with the Cochrane Collabration’s and identified them with hand searching and electronic searching individually. And the electronic searching words contained of treatment, effect of drug, controlled studies and blinded etc.

Results: The number of trial reports gradually increased year by year, especially in Chinese Journal of Integrated Traditional and Western Medicine. The number of reports both identified either with hand searching or electronic searching gradually increased. And the portion of average increased is more than 60% in Chinese Journal of Infectious Diseases over than the other journal.

Conclusion: The two methods both have advantage each other for Chinese database. Electronic searching can improve the efficiency before included in Chinese database for those journals, which indexed in electronic searching.

[P14] Lessons Learned and Ongoing Challenges in Developing an International, Collaborative Register of Controlled Trials with Many Contributors

Eric Manheimer, Carol Lefebvre, Hazim Timimi, Indy Rutks, Davina Ghersi, New England Cochrane Center, Department of Community Health, Brown University, Providence, Rhode Island, United States.

Background:  Since 1995, the Cochrane Collaboration has been developing a centralized register of controlled trials and other studies of healthcare interventions (called CENTRAL) to ensure that Collaborative Review Groups have access to as high a proportion as possible of all records that relate to studies that might be eligible for inclusion in Cochrane Reviews.  CENTRAL serves as a source of trials to be searched by Collaborative Review Groups to identify trials for their own subject matter-specific (“specialized”) trials registers.  These specialized registers, in turn, ensure that individual reviewers within a Collaborative Review Group have easy and reliable access to as many trials as possible relevant to their review topic.

Methods:  Broad CENTRAL record eligibility criteria were agreed in 1992. CENTRAL is recreated anew for each quarterly release of The Cochrane Library by merging the most recently submitted version of each of the Collaborative Review Groups’ specialized registers; a register of trial reports identified by page-by-page handsearches of health-related journals; and registers of reports downloaded from electronic bibliographic databases (e.g., MEDLINE and EMBASE). Because of the methods used in its development, CENTRAL is not a fixed, stable electronic bibliographic database but rather an amalgamation of multiple smaller, ever-changing, independent component registers.

Results:  Several lessons have been learned in developing CENTRAL: 1) A clear and transparent manual should document the processes used by the developers (e.g., the New England Cochrane Center, Providence Office and Update Software) as well as the procedures to be followed by contributors; 2) Contributors should download available records from electronic bibliographic databases when appropriate permissions have been obtained; 3) All people who submit records should be well-trained trials search coordinators who can assure the quality of their submissions, and if resources are available, a duplicate quality check should be performed centrally; 4) All files transferred among different groups participating in this collaborative project should conform to agreed file structures and definitions; and 5) Definitions of eligibility criteria for the centralized register should be established early on, and refined and expanded as necessary.

Some ongoing challenges include reducing the number of duplicate citations and preventing submission and inclusion of citations that do not meet the eligibility criteria for CENTRAL.  Efforts underway to meet these challenges will be reviewed.

Conclusions:  Many lessons have been learned in developing CENTRAL and some of these may serve to inform similar projects under development (e.g., the Campbell Collaboration’s Social, Psychological, Educational, and Criminological Trials Register (SPECTR) and the European Union Psi-Tri Project).

Systematic reviews – Methods & Quality

[P15] Open Learning for Cochrane Reviewers.

Phil Alderson, UK Cochrane Centre, Oxford and Sally Green, Australasian Cochrane Centre, Melbourne

Aim: To develop a set of training materials to allow Cochrane systematic reviewers to train away from Cochrane Centres, with flexible time and format.

Objectives:

• To provide a companion product to the Cochrane Reviewers’ Handbook to assist Reviewers in navigating the Handbook and provide material additional to the Handbook
• To guide Reviewers through performing a systematic review such that at completion of each module of the material a consecutive part of their review could be completed
• To increase the access to training for reviewers in remote locations
• To improve the quality of Cochrane reviews through more comprehensive reviewer training
• To provide an ongoing reference for reviewers at the completion of training

Methods: A collaborative project between Cochrane Centres and the Statistics Methods Group was completed in July 2002, approved by the Handbook Advisory Group and implemented with the help of a Steering Committee comprising members of the Cochrane Collaboration with an interest in training reviewers.  The materials were produced in self contained CD-ROM and paper based format, with optional links to relevant Internet sites, to ensure equal access for reviewers without Internet facility. A set of principles ensuring free access to Cochrane reviewers and appropriate use by non-Cochrane reviewers were established.

Results: The program comprises 20 core and three additional modules, the content and format of which of which will be displayed.

[P16] Why do Systematic Reviewers Choose Paper over Electronic (Cochrane) Publication?

Janet Piehl, Sally Green, and Steve McDonald, Australasian Cochrane Centre, Melbourne, Australia.

Objective:  To identify why authors choose to publish systematic reviews outside of the Cochrane Collaboration, to gauge whether authors might be interested in converting their reviews to Cochrane format, and to determine the resources necessary to achieve this aim.

Methods:  Cross-sectional survey of Australian primary authors of systematic reviews identified from the Database of Abstracts of Reviews of Effectiveness (DARE).

Results:  We identified 88 systematic reviews from DARE with an Australian as the primary author, surveying the 73 authors for whom contact information was available.  The response rate was 63% (46/73).  The most frequently cited reasons for not undertaking a Cochrane review were:  lack of time (78%), the need to undergo specific Cochrane training (46%), unwillingness to update reviews (36%), difficulties with the Cochrane process (26%) and the review topic already registered with the Cochrane Collaboration (21%).  However, nearly half of respondents (34/73) would consider converting their review to Cochrane format.  Dedicated time emerged as the most important factor in facilitating the potential conversion process.  Other factors included navigating the Cochrane system, assistance with updating, and financial support.  Almost all respondents (86%) would be willing to have their review converted to Cochrane format by another author.

Conclusions:  Time required to complete a Cochrane review and the need for specific training are the primary reasons why some authors publish systematic reviews outside of the Cochrane Collaboration.  Encouragingly, almost half of the authors would consider converting their review to Cochrane format.  Ways of supporting these authors and how to provide dedicated time to convert systematic reviews needs further consideration.

[P 17] Which Electronic Resources Should be Searched to Identify RCTs for Systematic Reviews: A Systematic Overview of the Literature

Ellen Crumley, Lisa Hartling, Natasha Wiebe, Kelly Russell, Terry Klassen, Alberta Research Centre for Child Health Evidence, Department of Pediatrics, University of Alberta, Aberhart Centre One, Room 9419, 11402 University Avenue, Edmonton, Alberta T6G 2J3 CANADA

Objective: To systematically identify and review studies comparing different electronic resources (e.g., databases, Internet) used to search for trials (i.e., CCTs and RCTs) for systematic reviews. 
Methods: Eight electronic databases (MEDLINE, EMBASE, CINAHL, ERIC, Library Literature & Information Science, PsycLit, Web of Science, Cochrane Library) will be searched. A ninth, LISA, Library Information Science Abstracts, will be handsearched. Search strategies will be specific and tailored for each database. In addition, key authors will be contacted and messages will be sent out to list-servs asking for additional relevant papers. References of relevant articles will also be screened. Two people will review the retrieved articles and apply inclusion/exclusion criteria to each one. Disagreement will be resolved by discussion. Relevant articles will be assessed for quality according to CRISTAL (Critical Skills Training in Appraisal for Librarians), created by Anne Brice et al. at Oxford University. The following information will be extracted from relevant articles: study objectives, databases and other electronic resources searched, subject being searched, comparisons made, number of RCTs identified from each source, numerical summaries presented and conclusions. A qualitative analysis will be conducted and, if possible, a quantitative analysis will be done.

Results: Results will be available by July 2002. 
Conclusions: This study will aid in developing recommendations for which sources to search in order to identify RCTs and CCTs for systematic reviews. The next step is to conduct a systematic review of search strategies for the databases identified in this review.

[P18] A Typical Cochrane Review:  How Many More are Needed to Cover Existing Evidence?

Susan Mallett and Mike Clarke. UK Cochrane Centre, NHS Research and Development Programme, Ta bort mellomrom

Oxford, OX2 7LG, UK.

Objective: To describe a typical Cochrane review in terms of the number of studies listed as included studies, ongoing studies and studies awaiting assessment.  To use this information to provide an estimate of how many Cochrane reviews would be needed to assess all studies currently listed in The Cochrane Controlled Trials Register (CENTRAL).

Methods: 989 reviews from The Cochrane Database of Systematic Reviews in The Cochrane Library, Issue 1, 2001 were analysed for the number of included studies, ongoing studies and studies awaiting assessment per review.  Included studies are those meeting eligibility criteria for the review, and where information is included.  The number of references cited per study was extracted from a random sample of reviews.

Results:  The 989 Cochrane reviews contained 9,778 included studies, with the typical Cochrane review containing 6 studies (based on the median number per review).  17% of reviews listed ongoing studies that met review criteria but where the results of the study were not yet available for inclusion.  29% of reviews listed studies awaiting assessment of whether these should be included in the review. The number of references per study within Cochrane reviews was used to provide an estimate of the number of trials referenced by 300,00 reports in CENTRAL.  This was used to provide an estimate of the number of additional Cochrane reviews that would be needed for systematic reviews to cover all these studies. 

Conclusions: 9,778 trials were included in 989 Cochrane reviews in The Cochrane Library, Issue 1, 2001.   A typical Cochrane review included 6 studies and 6.6 references.  With an average Cochrane review containing six studies, this would correspond to 45,000 Cochrane reviews being needed to cover the more than 300,000 references in CENTRAL (approximately 270,000 studies).  It is, however, possible that 1.1 references per study is an underestimate.  For example, the Cochrane Stroke Group found an average of  2.1 in their Specialized Register of Stroke Trials (4,525 reports corresponding to 2,132 studies).  On the basis of this figure, the number of additional Cochrane reviews would be estimated as 24,000.  In addition not all references in CENTRAL or the studies they report, might be suitable for new Cochrane reviews.  There will be references to studies already within Cochrane reviews and some references appear more than once.  In addition some of the studies will relate to interventions that are no longer used or information that is not relevant to health care decisions, and some studies may be eligible, but not yet included, in existing Cochrane reviews.  Given that 45,000 may be a gross overestimate, it is difficult to know how many Cochrane reviews would be needed, but we predict that at least another 10,000 Cochrane reviews are needed to cover a substantial proportion of the studies relevant to health care that have already been identified

[P19] Describing Heterogeneity in Meta-analysis Involving Cluster Randomized Trials: Normality versus Nonparametric Approaches of Random Effects Models

Malinee Laopaiboon, Dankmar Böhning, Department of Biostatistics & Demography, Faculty of Public Health, Khon Kaen University, Khon Kaen, Thailand

Objective: The purpose of this study was to compare the general linear mixed model (GLM) with the generalized linear mixed model (GLMM) for describing heterogeneity in meta-analysis involving cluster randomized trials in binary outcome.

Methods: The two approaches of GLM and GLMM were exemplified in two published meta-analyses involving cluster randomized trials. The first meta-analysis was done to assess the effectiveness of multiple risk factor interventions to reduce cardiovascular risk factors from coronary heart disease. Analysis was performed in the 14 trials included that provided smoking prevalence outcome. The second meta-analysis comprised fewer trials of 8, which was performed to evaluate the effect of mammographic screening on reduction of breast cancer mortality. Observed log-relative risks for individual trials are fitted to the GLM as a continuous response. Randomization design was treated as a covariate of the model. The model parameters were estimated with the restricted maximum likelihood (REML) under the normality assumption of random effects. For the GLMM, observed frequencies of the outcome for each treatment group that approached to poisson distribution were used rather than the observed log-relative risks for individual trials. A canonical link function of the observed mean proportions was associated with linear predictors model of which treatment and randomization design were treated as covariates. The model parameters were estimated non-parametrically under a discrete mixture distribution of random effects for K components. Maximum posterior probability were used to classified trials to each component. 

Results: The two approaches shown that the covariates effects and variability of random effects from the models easily explained heterogeneity between trials. The GLMM was superior to the GLM in some aspects. The GLMM gave further heterogeneity information from random treatment effects. In addition, it provided component (or subgroup)-specific treatment effect and trial classification according to the optimal components. This was very useful in further explaining the heterogeneity that might be beyond the effects found in the model.

Conclusions: The GLM and GLMM approaches were preferable for meta-analyses involving cluster randomized trials. However, care should be taken when using the GLM because the GLM needed a strong assumption of normality distribution of random effects components. It was also difficult to verify validity of the assumption. For the GLMM, care should be taken when interpreting treatment effect in terms of risk since the inference on treatment effect obtained from a discrete mixing distribution had not been ruled out. Nevertheless, these two approaches would be much more efficient when they were applied to large meta-analyses.

[P20] Impact of Grey Literature on Meta-Analyses of Randomized Trials – A Systematic Review

Sally Hopewell, Steve McDonald, Mike Clarke, Matthias Egger. The UK Cochrane Centre, Oxford, United Kingdom.

Background: The inclusion of grey literature (i.e. literature that has not been formally published) in systematic reviews may help to overcome some of the problems of publication bias, which can arise due to the selective availability of data. There is now some evidence in support of this, suggesting that the exclusion of grey literature from meta-analyses can lead to an exaggeration of the effect of treatment.

Objective: This study aims to review systematically research studies, which have investigated the impact of grey literature in meta-analyses of randomized trials. A study will be considered eligible for this review if it compares the effect of the inclusion and exclusion of grey literature on the results of meta-analyses of randomized trials.

Methods: Studies will be identified by searching the Cochrane Methodology Register, MEDLINE, EMBASE, Science Citation Index and by handsearching journals and conference proceedings. The main outcome measure will be an estimate of the impact of trials from the grey literature on the pooled effect estimates of the meta-analyses. Information will also be collected on the area of health care, the number of meta-analyses, the number of trials, the number of trial participants, the year of publication of the trials, the language and country of publication of the trials, the number and type of grey and published literature, and methodological quality.

Results and Conclusions: As of February 2002, two studies have been identified which assess the impact of including grey literature in meta-analyses of randomized trials. The results of these studies and any other studies identified in the interim will be reviewed.

[P21] Does The Non-Randomised Controlled Study Have a Place in the Systematic Review? A Pilot Study.

Michael Ferriter, Nick Huband, Nottinghamshire Healthcare NHS Trust, Research Department, Rampton Hospital, Woodbeck, Notts DN22 0PD, UK

Objective: A major issue in systematic reviews is what types of studies should be included or excluded from the review. The Cochrane Collaboration has traditionally viewed the RCT as the ‘gold standard’. However, many Cochrane reviews are inconclusive because of insufficient RCTs while rejecting large numbers of non-randomised studies. This is particularly true in mental health, a domain where RCTs may be particularly problematic. Earlier research indicated that non-random studies produced larger treatment effect scores than RCTs in the same domain but subsequent research has cast doubt on this. An emerging, alternative view is that good quality non-randomised studies may be reliable surrogates for RCTs and systematic reviews could become more informative if reviewers knew when, and under what circumstances, non-randomised designs are acceptable for inclusion alongside RCTs. This pilot study tests a method to explore the issue further.

Method: Two reviews from the Cochrane Schizophrenia Group were selected and the results of the RCTs included in the review were compared with the outcomes of non-randomised control studies excluded from the reviews. Comparison was made between randomised and non-randomised studies and between high and low quality studies as measured by Downes and Black’s quality checklist.

Results: It was only possible to identify three outcomes shared by both randomised and non-randomised studies for comparison. One outcome showed greater treatment effect in RCTs, another showed RCTs having a smaller treatment effect and a third showed no difference. There was a consistent finding, though varying in magnitude, that high quality studies showed smaller treatment effects than low quality studies.

Conclusions: These limited findings lend support to the view that the quality of the study has a greater impact on treatment effect size than randomisation alone and that randomisation should not be seen as a reliable proxy for overall quality. The problems and issues still to be resolved are discussed with recommendations for future research.

[P22] Is it Possible to Perform a Meta-Analysis When Only the Median Survival Time is Known? A Comparison with Individual Patient Data Results

Stefan Michiels, Nathalie Syz, Pascal Piedbois, Sarah Burdett, Lesley Stewart, Jean-Pierre Pignon, Department of Public Health, Institut Gustave Roussy, Villejuif, France

Introduction: As a first step for an individual patient data (IPD) meta-analysis on metastatic lung cancer, a meta-analysis of the literature was planned. When sufficient summary statistics such as p-values from the logrank test are available, the methods proposed by Parmar et al. (Statist. Med. 17, 2815-2834) can be used.  However, in this case the summary statistics reported in the retrieved publications were often only the median survival times (MST) in both treatment arms. The use of such a summary for a meta-analysis is controversial.

Objective: We aim to evaluate the performance of meta-analyses using median survival times by comparing its results with the results of IPD meta-analyses of  the same randomized trials. We will focus on meta-analyses involving cancers with high mortality rates, e.g. lung cancer. 

Methods: We will calculate a pooled ratio of median survival times (Simes, Statist. Med. 6, 11-29). The variance of the ratio of the median survival times in each trial will be approximated using the total number of patients. The median survival times will be calculated from the IPD database rather than taken from publications. In this way we will compare like with like. The same trials, patients and extended follow-up will be used in each analysis. The IDP meta-analyses on which the comparisons are made, consist of meta-analyses carried out by the Institut Gustave Roussy, the Meta-Analysis Group in Cancer (MAGIC) and the Meta-Analysis Group from the Medical Research Council Clinical Trials Unit.

Results: The three lung cancer meta-analyses, for which the results of homogenous trial sets are tabulated below, are the prophylactic cranial irradiation overview on small cell lung cancer (lung 1), the locally advanced (lung 2) and advanced settings of the non-small cell lung cancer meta-analysis on chemotherapy (lung 3).  More comparisons with other meta-analyses will be presented at the meeting.  The same patterns can be discovered in the analyses based on the MST method as in the real IPD meta-analyses. The differences in the estimation of the overall hazard ratio (HR) for the IDP method and the estimation of the pooled median ratio (MR) for the proposed MST method stem from differences of the estimations of the hazard ratio at the trial level, in particular when the differences between the survival curves are not constant over time.

Conclusions: The results of a simple summary data method based on the median survival time are compared with the results from IDP meta-analyses with high mortality rates. The only difference in estimation relates to bias of the statistical method. Under- or overestimations of the overall hazard ratio may occur. However, based on the comparisons with IDP meta-analyses, the simple MST method seems to have practical and exploratory value. Other differences will come into play if used as part of a meta-analysis of the published literature (unpublished trials, patient exclusion, duration of follow-up).

[P23] Does the Schedule of an Intervention Differ weather it is Used as Experimental or Control? The Experience of The Cochrane Drugs and Alcohol Group

Ferri Marica, Amato Laura, Davoli Marina,  Vecchi Simona, Perucci Carlo A.

Introduction: The Cochrane Drugs and Alcohol group published 5 different reviews on treatments for opiate withdrawal. Some of the reviews share the same studies which are then analysed differently. A treatment which is used as intervention in the primary study may be used as intervention in one review and as control in another review. Some studies suggest that doses of the same drug can differ according to weather it is used as experimental or control.

Objectives: To investigate the differences in dosage and modality of administration of treatments used as experimental intervention or as control.

Methods: We analysed the studies included in the 5 reviews on opioid detoxification already published on the Cochrane Library. From the tables of included studies, we selected the different pharmacological treatments and collected the available information on doses offered. For every single treatment agent, we calculated the mean dose and the standard deviation both for the experimental group and the control group. The mean dosages where compared using the student t test.

Results: The studies included in the 5 reviews were 37, with a total of 2498 participants (range 20 – 200) and 43 comparisons. We identified 3 main different treatments related to detoxification with a total of 1570 subjects involved in the comparisons. Twenty-three trials included methadone, 11 as experimental treatment (subjects= 163), doses available for 8/11, mean dose 51.25mg, SD 45.2, 17 as control (subjects= 472), doses available for 15/17, mean 41.6mg, SD 31.0, p=0.55; 23 trials investigated clonidine, all the studies included had information on doses,  19 as experimental treatment (subjects=623), mean dose1.21mg, SD 0.78, 4 as control (subjects=103), mean 0.75mg, SD 0.5, p=0.27;  7 trials included lofexidine, all the studies included had information on doses, 4 as experimental treatment (subjects=144), mean dose 2.0mg, SD 0, 3 as control (subjects=65), mean 3.0mg, SD 1.7, p=0.28.

Conclusions:   As far as detoxification treatments for opiate dependence are concerned, the doses administered were heterogeneous among the studies but there were no statistically significant differences weather the pharmacological agent was given as experimental treatment or as control intervention.. In this specific case the choice of some reviewers to switch control or treatment groups according to the review protocol seems feasible and acceptable.

[P24] Are Cochrane Reviews Updated Regularly or Not?

Georg Koch, German Cochrane Centre, Freiburg, Germany

Background: Updating the Cochrane Reviews is part of the mission of the Cochrane Collaboration. Reviewers are expected to update their reviews at least every 2 years. A preliminary analyses in 1998 suggested that this is not done.

Objective: To find out if Cochrane reviews are updated or not.

Methods: The date fields of the cover sheets of all reviews of the Cochrane Library 2002 Issue 1 were extracted and analysed.

Results: More that 95% of all reviews were edited within the last 2 years (see table).

All reviews had valid 'date of most recent amendment' and a 'date of most recent substantial amendment' fields. The other dates recommended in the Appendix 2a of the Reviewers Manual are not used: 2 out of 3 reviews (867/1268) do not provide any of: date new studies sought but none found, date new studies found but not yet included/excluded, date new studies found and included/excluded, date reviewers' conclusions section amended.

Interpretation: It appears that 95% of the reviews are amended as expected. However, since Review Manager 4 was introduced in 1999 and most reviews do not provide procedural dates, two interpretations are possible:

• reviewers update the reviews regulary but forget to document their procedure
• the reviews were not updated but only imported into Revman4 or edited insignificantly.

The question of the analysis could not be answered.

Conclusions: A strategy to assure the use of the procedural date fields in the cover sheet should be deviced. Without those fields it is impossible to decide if a review was updated or only edited.

[P25] DNAR? Do Not Attempt Resuscitation or Do Not Attempt Review?

Sophie Hill, Alex Broom, Neil Thalagala, Judy Stoelwinder, Kate Silburn, Tom Hitchcock, School of Public Health, La Trobe University, Melbourne, Australia

Objective: To develop a ‘reviewable’ question for an intervention in a complex environment.

Methods: Following identification of the necessity for a review of interventions to promote communication with adults for do-not-resuscitate orders, stimulated by journal debate after editorial by Ebrahim, British Medical Journal, 2000, we undertook a series of iterative searches of Medline, 1966 - 2001, expanding from resuscitation orders and trial designs, to include resuscitation decisions or policy, advance directives, living wills, right to die, passive euthanasia, informed consent, and all study designs.  Several team meetings (over 6 months) were held to resolve a consensus approach to a diverse range of research ‘challenges’, prior to the detailed identification of participants, interventions and outcomes, and prior to the submission of the title proposal. These challenges included: the social, clinical, contextual and temporal complexity of decision-making scenarios; implications of evidence concerning socially discriminating decisions about who should be resuscitated; intertwining of do-not-resuscitate orders and advance directives; potentially conflicting aims of promoters of advance directives (for example, reducing hospital stays or enhancing individual autonomy); diversity of interventions that could be classed as communication strategies; multiplicity of measured outcomes; conflicting/changing views of resuscitation study participants regarding best outcome, and adequacy of search strategy for non-trial designs.

Results: Team decisions taken are:

• to split, and conduct two linked reviews on (a) do-not-resuscitate orders and (b) advance directives. Title proposals for submission now titled: ‘Interventions to promote communication for advance directives/do-not-resuscitate orders for adults’;
• that outcomes for advance directives to include two categories: a) process of being informed, and: b) effect of being informed. Principal outcome to relate to individual adult, but secondary outcomes sought on family/carer, health professionals, and system for both 2a and 2b;
• that review on do-not-resuscitate orders to include a systematic search for, and narrative summary of, findings of observational studies on end-of-life decision-making and care, linked to Background of review, and used to (a) identify social characteristics, views and patterns of communication of people (prospective/past patient and/or family, health professionals); (b) document the assumptions underpinning interventions to promote communication on advance directives and resuscitation orders; and c) inform discussion of studies in review;
• to identify consumer organisations who have undertaken research with members around decision-making at end-of-life, for clarification of key outcomes for patients and family members;
• consult local clinicians for their input to designation of outcomes for patients and family members;
• to develop a glossary of study designs, for all designs, with examples where possible from Consumers and Communication Review Group Trials Register or from Medline.

Conclusions: Reviews of interventions that are applied in complex environments where social views closely intersect with clinical decision-making are reviews that require substantial investment of time prior to title development. Additional resources and guides to aid reviewers had to be developed before review could commence. The balance between broadening the review scope and completing the review is a mix of idealism and pragmatism.

[P26] Do We Analyse Symptom Outcomes Correctly for Intervention Trials in Spontaneously Remitting Illnesses?

CB Del Mar, J Doust . University of Queensland, Brisbane, Australia

Objectives: To model the effect of measurement of only one parameter for the outcome of spontaneous remitting illness.

Methods: Trials of intervention directed at symptoms for spontaneously remitting illnesses usually use time-to-recover (eg. time for a set percentage of people to recover; or percentage of people recovered at a set time).  However, the amount of illness can be represented by severity as well as time (eg. severity x time).  We demonstrate graphically the differences between two methods.

Results: Estimating differences between two-dimensional constructs by single dimensions is likely to yield under-estimates if severity contributes an important amount to the illness.  Examples are drawn from interventions for acute respiratory infections.

Conclusions: It may be, therefore, that past trials have under-estimated the effects of many interventions for symptoms.  In future trials we should collect daily severity data to enable such analyses.

[P27] Rethinking Trials of Antibiotics for Acute Respiratory Infections:  Taking Account of Recruitment Exclusion of The Most Ill.

CB Del Mar, J Doust. University of Queensland, Brisbane, Australia

Objectives: trials of antibiotics for symptoms of ARIs have developed in an environment in which antibiotic use was already established.  Thus trials have been of "no-antibiotic" vs usual care (antibiotics).  This might influence recruitment (less severely affected vs more).  If severity influences response to treatment, then excluding more severely affected patients would yield a smaller effect size.

Method: we reanalysed the trials selected for the Cochrane meta-analysis of «antibiotics for acute otitis media in children», looking for evidence of patients excluded on the basis of being too ill.  We also looked for evidence of severity influencing outcome.

Results: We could extract ‘non-recruitment because the child was too ill’ out of the total recruited from only two of the seven trials. They were 52/232 and 27/240 respectively, or 17%.

Conclusions: This figure has the potential to result in under-estimates of the effects of antibiotics for acute otitis media.

[P28] Reducing Bias and Increasing Power by Imputing Missing Standard Deviations for Continuous Outcomes in Systematic Reviews

Fredric M Wolf, James P Guevara, University of Washington, Seattle, Washington, USA

Objectives:  To examine 1) methods for imputing missing standard deviations for continuous outcomes that are not included in primary studies, 2) impact of including effect sizes with imputed standard deviations in pooled results of meta-analyses and systematic reviews, and 3) potential biasing effects of including or excluding these estimated effects in reviews.

Methods:  Investigators sometimes fail to report estimates of dispersion in primary studies. Often only means, F or t-statistics, or p-values are provided for continuous outcome measures. Unless estimates of standard deviations (SDs) can be imputed, effect sizes cannot be estimated and these findings cannot be pooled and included in meta-analyses. Sometimes findings are reported only as significant (p <.05) or non-significant, or even not at all even though outcomes are described in methods sections. A reasonable assumption is that these results were probably statistically non-significant or they would have been reported. We suggest taking the following approaches when standard deviations are not reported in primary studies:

• If either standard errors of the mean or confidence intervals are provided, use standard statistical formulas to compute SDs.
• If t-statistics are provided, impute estimates of pooled SDs from generalized formula for this statistic.
• If p-values, but not t-statistics, are reported, use exact p-values to identify the corresponding t-statistics (with appropriate df) and proceed as in approach 2.
• If only significance or non-significance is reported, use t-statistics (with appropriate df) corresponding to p = .05 (for reported p < .05) or p =.50 (for non-significant results) as in approach 2.

We used the above approaches to examine the impact of imputing missing standard deviations for a Cochrane systematic review that examined the effects of asthma self-management education on patients’ physiological, functional status, and health care utilization outcomes.

Results:  Of 30 controlled trials eligible for inclusion in the review, SDs for outcomes were missing in 11 trials (37%).  When we imputed estimates for these missing SDs, we were able to include additional data for 8 of 16 primary outcomes in the review (50%), thereby increasing sample size (and statistical Power) and the precision of estimates of effect (narrowing confidence intervals for standardized or raw weighted mean differences, d).

Conclusions: Systematic bias can occur if study results for continuous outcomes are not included in pooled analyses. Standard deviations were unreported in over one-third of the primary studies included in the Cochrane systematic review that we examined in detail. These missing data pertained to one-half of the primary outcomes. Exclusion of individual study effect sizes typically results in under estimation of pooled effect sizes when findings are statistically significant, and over estimation of pooled effects when findings are not significant. In both instances, including these outcomes increases statistical Power and precision of estimates of effect. It is desirable to impute values for missing SDs for continuous outcomes in primary studies so effect sizes may be estimated and pooled in reviews rather than exclude results because of missing values. When imputing missing values, it is important to describe clearly the methods used.

[P29] In Some Systematic Reviews Placebos May Not be Necessary: An Example From a Statin Dose-Response Study

Michael B. Tsang, Stephen P. Adams, Ciprian Jauca, James M. Wright, addresse opp

University of British Columbia, Department of Pharmacology and Therapeutics, Vancouver, BC Canada

Background:  When determining the dose-related response of a drug treatment on a continuous objective outcome, a lot of potentially valuable data is lost if trials without a parallel placebo (baseline-controlled trials) are excluded. Insufficient trials could limit the ability to construct a comprehensive dose-response relationship. 

Objective:  In an attempt to determine the comprehensive dose-response effect of fluvastatin on total cholesterol and LDL cholesterol, we tested whether it was possible and appropriate to include baseline-controlled trials. We did this by: 1) comparing of the effect size in placebo-controlled trials with the effect size in baseline-controlled trials; 2) comparing the placebo group effect size with zero.

Methods:  1) After stratification by dose (20mg, 40mg, 80mg), the effect-size of pooled placebo-controlled treatment groups (N=1841) was compared with that of pooled baseline-controlled treatment groups (N=3782). This comparison was made using a two-tailed unpaired t-test.  2) The effect-sizes of placebo groups were pooled after stratifying by dose (2.5 mg, 5 mg, 10 mg, 20 mg, 40 mg, and 80 mg doses).  The total number of patients was 1109 for total cholesterol measurements and 1144 for LDL cholesterol measurements.  A two-tailed one-sample t-test was used to determine if the mean value of pooled placebo groups was significantly different from zero.

Results:   The treatment effect for the baseline-controlled trials was not significantly different (p>0.1) from the treatment effect for placebo-controlled trials.  For each of the dose stratification group comparisons, placebo effect-size was not significantly different from zero (p>0.1).

Conclusions: In this example, meta-analysis of trials with an objective laboratory measurement showed no significant placebo effect.  Under these circumstances, baseline-controlled trials can be included in REVMAN by setting the placebo effect as zero and imputing the standard deviation. This increases the precision of the effect size estimation for each dose and thus allows a better estimate of the dose response relationship.

[P30] Quality Assessment in Cochrane Reviews : Do We Practice What W0e Preach?

Telaro Elena, D’Amico Roberto , Moja Pasquale, Battaglia Alessandro, Bianco Elvira, Calderan Alessandro,  Colli Agostino, Di Pietrantonj Carlo,  Ferri Marica, Fraquelli Mirella, Girolami Bruno, Marchioni Enrico, Mezza Elisabetta, Piccoli Giorgina, Vignatelli Luca, Liberati Alessandro (members of  “Milano Master Course in Systematic Reviews”)

Italian Cochrane Centre Milano Italy

Background: One of the most important steps in a systematic review (SR) is the critical appraisal of the quality of primary studies. Many studies have been published on the use of checklists and scales to assess methodological quality. The Cochrane Collaboration Handbook provides general principles that should be followed by the reviewers in an attempt to assess the quality of the primary studies. Nevertheless, there is still discussion about some issues such as:

a) what is the most valid scale/checklist for the quality assessment ?

b) what should be the use of quality assessment in the context of SRs?

Objectives: The aim of this project is to review the approaches used in the quality assessment in Cochrane Reviews.

Methods: A sample of SR’s based on 50% of those published on the Cochrane Library Issue 1, 2002, stratified by Collaborative Review Groups (CRGs) and type of intervention (drugs, rehabilitation, prevention/screening, surgery/radiotherapy, intervention, communication/organisational/educational, other) were eligible for this study. Each CRG module and review has been reviewed by two people independently using two checklists specifically developed for this project.

Results: Preliminary results based on a sample of 10% of all SRs show that ad hoc developed scales are the most frequently used tools for the assessment of the quality of studies, while 28% of the reviews use either Jadad or Schultz scales. The items that are most widely considered are: allocation concealment (78%) and completeness of follow-up (64%). Very often, an operational and reproducible definition of these items is not clearly reported in the methods nor in the methodological quality section. In 52% of the reviews items that are used do not correspond to items which were stated a priori in the methods section.  64 reviews (55%) do not report how they intend to use the results of the quality assessment and 13% of these will use it either as a criterion for study exclusion or for sensitivity analyses. In the majority of cases (69%) quality assessment is only reported in the “methodological quality section” and it is not linked to the results of the analyses.

Conclusions: The results of this preliminary analysis show that despite the attention given to quality assessment of primary studies in the Cochrane Collaboration there is still substantial variation in the way quality of studies is assessed. Moreover, the way this assessment is eventually used in the analysis and interpretation of the results suffers from several inconsistencies. The poster will present full results and discuss the association between type of quality assessment and characteristics of the SR’s. It will also address the opportunities for improving the consistency of Cochrane reviews in these important aspects.

[P31] Cochrane Reviews of Health Promotion and Public Health Interventions - Improving Quality, Relevance and Utility

Elizabeth Waters, Jodie Doyle, Cochrane Health Promotion and Public Health Field, Melbourne, Australia, Ginny Brunton, Mark Petticrew

The Cochrane Health Promotion and Public Health Field seeks to support the production of reviews of health promotion and public health interventions that are of high quality and contains information that is relevant and useable to practitioners and policy makers.  In order to fulfill this obligation the Field has identified and implemented several strategies to move forward.  Our efforts have been informed by the comments and criticisms received by current and potential users of Cochrane reviews within this area and from reviewers of health promotion and public health topics.

This poster presentation will outline the strategies the Field has developed in order to best meet the needs of all stakeholders. These include:

• A scoping exercise to identify past and current scope of Cochrane reviews and titles of health promotion and public health topics
• Methods to determine the priorities for future Cochrane reviews of health promotion and public health topics
• Identification of the concerns and criticisms of Cochrane reviews from within the health promotion and public health professions and the expressed and implied barriers to stakeholders producing and/or using these reviews to guide policy and practice
• The development of guidelines tailored to the needs of reviewers of health promotion and public health topics, as an addendum to the Cochrane Handbook
• Strategies to work with relevant CRGs to ensure the referee and editorial directives and processes for these type of reviews reflect the needs and concerns of potential end users

[P32] Methods for Assessing Clinical Significance in Quality of Life Measurement

Jeff A. Sloan, David Cella, Marlene Frost, Gordon Guyatt, Mirjam Sprangers, Tara Symonds, Clinical Significance Consensus Writing Team, Department of Health Sciences Research, Mayo Clinic and Mayo Foundation, Rochester, MN, USA

The integration of quality of life (QOL) assessment is increasingly a routine part of oncology clinical research. The challenge for the QOL research community that remains unmet is to provide clinical researchers with cogent, coordinated, and accessible descriptions of how to tell when a clinically significant change in QOL has been achieved.

This session will present state of the science summaries on assessing clinical significance for QOL assessments. Six papers recently appeared in the literature produced by thirty international experts on QOL assessment gathered for a two-day “think tank” on this topic. The papers were targeted to a clinical audience in order to provide guidelines and examples of how to choose the appropriate QOL measures and how to tell when a clinically meaningful change has taken place. These papers deal with the following topics:

• Methods used to date for clinical significance
• Group versus individual clinical significance differences
• Single item versus summated scale scores
• Patient versus clinician versus population perspectives of clinical significance
• Assessing changes over time
• Incorporating clinical significance into clinical practice/industry

Synopses of each paper will be presented and discussed. The goal of this collection of papers is to provide those who might wish to assess QOL with a set of practical implementation guidelines balancing the theoretical framework with practical limitations. The meeting was focused specifically on oncology patient QOL assessment, but the results are at least partially generalizable to other populations.

Systematic reviews

[P33] A Cochrane Systematic Review of Stabilisation Splint Therapy for Temporomandibular Pain Dysfunction Syndrome

Ziad Al-Ani, Helen Worthington, Robin Gray, Philip Sloan, Stephen Davies, Oral Health Group, University Dental Hospital of Manchester, Manchester, United Kingdom

Background: Pain dysfunction syndrome (PDS) is the most common temporomandibular disorder (TMD). The aetiology  of PDS is multifactorial. Consequently many different therapies, some conservative and reversible, others irreversible, have been advocated for patient with PDS. A number of successful treatment outcomes have been reported. There are various types of occlusal splints described in the literature and they have different indications and functions. The stabilization splint (SS) is one such type of occlusal splint and is also known as the Tanner appliance, the Fox appliance, the Michigan splint or centric relation appliance. The stabilization splint is a hard acrylic splint and provides a temporary and removable ideal occlusion. Providing an occlusion by the use of splint therapy reduces abnormal muscle activity and produces ‘neuromuscular balance’.

 When properly constructed and adjusted, the SS delivers a good method of providing centric relation occlusion, eliminating posterior interferences, provides anterior guidance on anterior teeth, reducing neuromuscular activity, and obtains stable occlusal relationships with uniform tooth contacts throughout the dental arch. However, no systematic review of these trials (examining stabilisation splint therapy as a treatment of PDS specifically) has been published, and the true effectiveness of this splint for PDS has yet to be established.

Objectives: To establish the effectiveness of stabilisation splint therapy in reducing symptoms in patients with pain dysfunction syndrome (compared with any control group) using a Cochrane systematic review procedure and to aggregate overall survival results.

Methods: Using a comprehensive search strategy, all relevant studies were identified irrespective of language of publication. Every attempt was made to have non-English language papers translated.

All relevant articles and reports were assessed using previously prepared inclusion criteria form, two reviewers have assessed the relevance of each article independently. Disagreements were handled by discussion and by consulting a third reviewer. Additional information was sought from the authors when necessary. To reduce pre-formed opinions of experts in the area that can bias the assessment of the relevance of articles, one reviewer was not an expert in the area.

Results: Five studies were included in the review and subjective and clinical outcomes were recorded. Data showed no statistically significant difference between the effectiveness of SS, acupuncture and biteplates in treating PDS. However, the comparisons were based on a small number of patients with no standardization of the outcomes measured.

Conclusion: There was no evidence of a difference in the effectiveness of stabilisation splint therapy in reducing symptoms in patients with pain dysfunction syndrome compared with other conventional treatments like acupuncture. A standardization of the outcomes of the treatment of PDS should be established in the randomized control trials. 

[P34] Intravenous Immunoglobulin for Treating Sepsis and Septic Shock.

Marissa M. Alejandria, Mary Ann Lansang, Leonila F. Dans, Jacinto Blas V. Mantaring. University of the Philippines, Manila, Philippines.

Objectives: To estimate the effects of intravenous immunoglobulin (IVIG) in patients with bacterial sepsis or septic shock on mortality, bacteriological failure rates, and duration of stay in hospital. Methodology: We searched the Cochrane Infectious Diseases Group specialized register up to  November 2001; the Cochrane Controlled Trials Register, The Cochrane Library issue 4, 2001; MEDLINE 1966 to November 2001;  and EMBASE 1988 to September 2001. We contacted investigators active in the field for unpublished data. Randomised trials comparing intravenous immunoglobulin (monoclonal or polyclonal) with placebo or no intervention, in patients with bacterial sepsis or septic shock. Inclusion criteria, trial quality assessment, and data abstraction were done in duplicate. We conducted pre-specified subgroup analyses by type of immunoglobulin preparation. Results: Twenty-seven out of 55 studies met our inclusion criteria. Pooled analysis of all types of IVIG preparations revealed a significant trend toward reduction of mortality (n= 8,856; RR=0.91; 95%CI 0.86-0.96).  Overall mortality was reduced in patients who received polyclonal IVIG (n=492; RR=0.64; 95% CI 0.51 to 0.80). For the two high-quality trials on polyclonal IVIG, the RR for overall mortality was 0.30, but the confidence interval was wide (95% CI 0.09 to 0.99, n=91).  Mortality was not reduced among patients who received monoclonal antibodies such as anti-endotoxins (n=2,826 in 5 good-quality studies; RR=0.97; 95% CI 0.88 to 1.07) or anti-cytokines (n=4,318;  RR=0.93; 95% CI 0.86 to 1.01). A few studies measured secondary outcomes (deaths from sepsis or length of hospitalisation) but no differences in the intervention and control groups were identified except among those who received polyclonal IVIG, where sepsis-related mortality was significantly reduced (n=161; RR=0.35; 95% CI 0.18 to 0.69).

Conclusions: Polyclonal IVIG significantly reduced mortality and and is a promising adjuvant in the treatment of sepsis and septic shock.  However, all the trials were small and the totality of the evidence is insufficient to support a robust conclusion of benefit.  Adjunctive therapy with monoclonal IVIGs remains experimental.

[P35] High First Dose Quinine for Treating Severe Malaria

Afolabi Lesi, Martin Meremikwu.  Department of Paediatrics, College of Medicine, University of Lagos, Nigeria.

Background: Malaria is an important cause of deaths worldwide.  Quinine is either given as a series of uniform doses or with a high first (loading) dose followed by a series of uniform doses.

Objectives: To assess the clinical outcomes and adverse effects of a high first (loading) dose regimen of quinine with a uniform (no loading) dose regimen in patients with severe malaria.

Methods: We searched the Cochrane Infectious Diseases Group specialized trials register (May 2001) and, the Controlled Trials Register (Issue 2, 2001), MEDLINE (1966 to April 2001), EMBASE (1988 to March 2001), LILACS (La Literatura Latinoamericana y del Caribe de Informacion en Ciencias de Salud; 2000 39a Edition CD-ROM). We contacted researchers for unpublished and ongoing trials. Randomized controlled trials were selected.  Patients were adults or children with any form of severe malaria treated with intravenous quinine.  The intervention group had a loading dose of intravenous quinine (20 mg/kg as the first dose) while the control group had no loading (uniform) dose (10 mg/kg as the first dose). After the first dose, patients in both groups were given 10 mg/kg every 8 or 12 hours. The quality of trials included were independently assessed with regard to the allocation sequence, concealment of allocation, blinding, and completeness of the trial, using guidelines designed by the Cochrane Infectious Diseases Group. The data from the trials were extracted by one reviewer and independently cross checked by the second reviewer and analysed using Review Manager (Version 4.1).  We contacted all the authors of the trials included for clarification where necessary.  Binary data were combined using Relative Risk, and continuous data were combined using the weighted mean difference.

Results: Two trials involving 72 people (39 children and 33 adolescents and adults) were included. Regarding the primary outcome (death), there were fewer deaths in the high first (loading) dose group though it was not statistically significant (Relative Risk [RR] 0.43; 95% confidence interval [CI] 0.09 to 2.15).  With the secondary outcomes, we found that while a high first (loading) dose did not hasten the recovery of consciousness (weighted mean difference [WMD] 1.0; 95% CI -10.63 to 12.63) it was associated with faster clearance of parasites (WMD -7.44; 95% CI -13.24 to -1.64) and resolution of fever (WMD -11.11; 95% CI -20.04 to -2.18).  Concerning adverse effects, the high first (loading) dose was associated with deafness (RR 3.14; 95% CI 1.05 to 9.38) which was transient as it resolved within 2 weeks.  Nevertheless the loading dose was not associated with more neurological sequelae (RR 0.58; 95% CI 0.06 to 5.91) or convulsions (RR 0.73; 95% CI 0.29 to 1.84).

Conclusion: Quinine loading dose reduced fever clearance time and parasite clearance time and was not associated with increased convulsions or an increased incidence of hypoglycaemia. For clinicians using quinine in severely ill children, this is probably sufficient evidence to use a loading dose, whilst monitoring carefully blood glucose for quinine induced hypoglycaemia.

 [P36] Oophorectomy for Preventing Ovarian Cancer in Women with a Familial History

Richmal Marie Oates-Whitehead, Aileen Clarke, Royal College of Paediatrics and Child Health, London, UK

Objectives: The objective of this review was to examine the following hypotheses:

1.  Prophylactic oophorectomy reduces the ovarian cancer related mortality rate in women with a familial history of ovarian cancer.

2.  Pathological features of ovaries removed from women with a familial history of ovarian cancer differ to those of ovaries removed from non high risk women.

3.  Quality of life for women who had undergone prophylactic oophorectomy differed, either in a positive or a negative way, from that of non-oophorectomized women.

Methods: Electronic searches of  the Cochrane Gynaecological Cancer Group Trials Register, MEDLINE, EMBASE, CANCERLIT and several other trials registers were performed.  We also searched references from relevant articles and contacted authors where necessary.

As it was expected that randomised controlled trials would not be available, all trials on prophylactic oophorectomy in women with a familial history of ovarian carcinoma were eligible for inclusion.    However, a prerequisite for all trials was that they considered outcomes for women with a familial history of ovarian carcinoma as an independent group.  Outcome measures were required in the areas of morbidity and mortality, pathohistology and quality of life.

Reviewers independently assessed study quality and extracted data.  Studies that did not meet the following minimum criteria were excluded:

1.Prospective or retrospective cohort studies (with or without controls) where the incidence of primary peritoneal carcinoma (or ovarian type carcinoma) is the outcome reported.

2.Retrospective histological review of removed ovarian material using a blinded case control design.

3.Cohort studies where psycho-social outcomes are investigated and a control or comparison group was present. 

Nine studies met the inclusion criteria for the review.

Results: Although research to date is poor, the evidence that does exist suggests that the risk of ovarian cancer appears to be substantially reduced by oophorectomy, although the remaining risk at this stage is not properly quantifiable. 1,2

The results currently available do not strongly support the hypothesis that pre-malignant alterations (visible using light microscopy) are present in the clinically normal ovaries of women who either have a strong family history of ovarian cancer or who have tested positive for BRCA 1 or 2. 3,4,5,6,7 However, some significant differences have been found using light microscopy. 5,6,7

Neither of the two studies identified of psychosocial outcomes gives any definitive evidence in favour of, or against, prophylactic oophorectomy from a psychosocial perspective. 8,9

Conclusions: Although research to date is poor, the evidence that does exist suggests that the risk of ovarian cancer appears to be substantially reduced by oophorectomy. However, a significant but small risk of development of either ovarian remnant disease or primary peritoneal carcinoma remains. Practitioners should discuss the lack of evidence with the woman herself and describe the risks as presently available.  Decisions should be made on an individual basis until further research has been undertaken.

References

1Struewing JP. Watson P. Easton DF. Ponder BA. Lynch HT. Tucker MA. Prophylactic oophorectomy in inherited breast/ovarian cancer families. Journal of the National Cancer Institute. Monographs. 1995;17:33-5

2Piver MS. Jishi MF. Tsukada Y. Nava G. Primary peritoneal carcinoma after prophylactic oophorectomy in women with a family history of ovarian cancer. A report of the Gilda Radner Familial Ovarian Cancer Registry. Cancer. 1993;71(9):2751-5

3Stratton J, Buckley C, Lowe D, Ponder B. Comparison of prophylactic oophorectomy specimens from carriers and non-carriers of a BRCA1 or BRCA2 gene mutation. Journal of the National Cancer Institute.  1999;91(7):626-28

4Barakat R, Federici M, Saigo P, Robson M, Offit K, Boyd J. Absence of premalignant histologic, molecular, or cell biologic alterations in prophylactic oophorectomy specimens from BRCA1 heterozygotes.  Cancer.  2000;89(2):383-390

5Casey M, Bewtra C, Hoehne L, Tatpati A, Lynch H, Watson P. Histology of prophylactic removed ovaries from BRCA1 and BRCA2 mutation carriers compared with noncarriers in heredity breast ovarian cancer syndromes kindreds. Gynecologic Oncology.  2000;78:278-87

6Sherman M, Lee J, Burks R, Struewing J, Kurman R, Hartge P. Histopathologic features of ovaries at increased risk for carcinoma. International Journal of Gynecological Pathology.  1999;18:151-57

7Werness BA. Afify AM. Bielat KL. Eltabbakh GH. Piver MS. Paterson JM. Altered surface and cyst epithelium of ovaries removed prophylactically from women with a family history of ovarian cancer. Human Pathology. 1999;30(2):151-7

8Swisher E, Babb S, Whelan A, Mutch D, Rader J. Prophylactic oophorectomy and ovarian cancer surveillance. The Journal of Reproductive Medicine. 2001;46(2):87-94

9Fry A. Busby-Earle C. Rush R. Cull A. Prophylactic oophorectomy versus screening: psychosocial outcomes in women at increased risk of ovarian cancer. Psycho-Oncology. 2001;10(3):231-41

[P37] Alternative Therapies for Viral Hepatitis in Chinese Textbook of Infectious Diseases: What is the Evidence?

Jianping Liu, Min Yang. The Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, China

Background/objectives: Traditional Chinese medicines and therapies are widely used for treatment of viral hepatitis in China. The national Textbook of Infectious Diseases recommends these alternative therapies as viral hepatitis treatment. We assessed evidence strength of the recommendation in order to find beneficial documentations. 

Methods: Complementary/alternative medical therapies in the ‘Textbook of Infectious Diseases’ published by The People’s Publishing House of China was checked for viral hepatitis treatment. The textbook (4th edition) in 1995 is being used for undergraduate medical training in most medical universities and colleges in China. Electronic (MEDLINE and Chinese Biomedical Database) and manual searches (till the end of 2000) were combined to identify potential clinical trials of alternative therapies for viral hepatitis. The trials were included regardless of the publication status and language. Data on study design, participants, interventions, and the study outcome were extracted from each trial.

Results: We identified nine Chinese herbal medicines that were recommended for the treatment of viral hepatitis in the textbook. One herbal medicine Ganyanling (herb extract) was recommended for treatment of acute hepatitis C. Herbal extracts Bifendate (biphenyldimethyl-esterate), Stringy stonecrop herb, caryophyllin, Anisodamine, Krestin, Polyporus umbellatus polysaccharide, Ganyanling and mushroom polysaccharide were recommended for treatment of chronic hepatitis. Herbal injection Salviae miltiorrhizinae was recommended for treatment of severe viral hepatitis. Our searches identified 11 randomised trials and one quasi-randomised trial. They are small trials with average sample of 96 patients per trial (range from 16 to 156). None of the trials used blinding, and their quality was generally low. Only one trial used placebo as control intervention. Others used non-specific drugs like vitamins, and western drugs like interferon as controls. Eleven out of 12 trials had positive outcomes and made recommendation for treatment. Only one trial concluded with negative outcome.

Conclusions: We cannot find sufficient evidence for using Chinese herbal medicines in the treatment of viral hepatitis in the ‘Textbook of Infectious Diseases’ until now. In general, the methodological quality of Chinese randomised trials on herbs for viral hepatitis is very low. Accordingly, many trials have a considerable risk of producing a biased positive study outcome. It is therefore noteworthy that 92% of all trials reported a positive outcome and made treatment recommendations based on the findings. These treatment recommendations can therefore be misleading and herbal medicines for viral hepatitis cannot be used beyond well-designed randomised trials.

[P38] Iodised Salt for Preventing Iodine Deficiency Disorders

Taixiang Wu, Guanjian Liu, Ping Li, Christine Clar

Background: Iodine deficiency is the main cause for potentially preventable mental retardation in childhood and is still prevalent in large parts of the world.

Objectives: To assess the effects of iodised salt in comparison with other forms of iodine supplementation or placebo in the prevention of iodine deficiency disorders.

Search strategy: We searched the Cochrane Library, Medline, the Register of Chinese trials developed by the Chinese Cochrane Centre, and the Chinese Med Database. We performed handsearching of a number of journals (Chinese Journal of Control of Endemic Diseases, Chinese Journal of Epidemiology, Chinese Journal of Preventive Medicine, and Studies of Trace Elements and Health up to February 2001), and searched reference lists, databases of ongoing trials and the Internet. Date of latest search: November 2001.

Selection criteria: We included prospective controlled studies of iodised salt versus other forms of  iodine supplementation or placebo in people living in areas of iodine deficiency. Studies reported mainly goitre rates and urinary iodine excretion as outcome measures.

Data collection & analysis: As the studies identified were not sufficiently similar and not of sufficient quality, we did not do a meta-analysis but summarised the data in a narrative format.

Main results: We found six prospective controlled trials relating to our question. Four of these were described as randomised controlled trials, one was a prospective trial that did not specify allocation to comparison groups, and one was a large population-based study comparing different interventions. Comparison interventions included non-iodised salt, iodised water, iodised oil, iodation with potassium iodide versus potassium iodate. Numbers of participants in the trials ranged from 35 to 334; over 20,000 people were included in the population-based study. There was a tendency towards goitre reduction with iodised salt, although this was not significant in all studies. There was also an improved iodine status in most studies (except in small children in one of the studies), although urinary iodine excretion did not always reach the levels recommended by the WHO.

Reviewers' conclusions: The results suggest that iodised salt is an effective and safe means of improving iodine status. However, high quality controlled studies are needed to address questions of dosage and best means of iodine supplementation in different population groups.

[P39] Medical Management for Miscarriage

Juan C Vazquez, Martha Hickey, James P Neilson. Hospital "America Arias", Ciudad Habana, Cuba.

Background: Miscarriage is an important cause of morbidity and mortality during the first half of pregnancy, especially in developing countries. Traditionally, surgical curettage was performed to remove any retained products of conception. Various types of medical treatment could be suitable as alternatives to surgical treatment, such as Misoprostol and other drugs, including ergometrine, oxytocin, prostaglandins, mifepristone and methotrexate.

Objectives: To assess the effectiveness and safety of different managements for miscarriage, in terms of death or complications, additional surgical evacuation, blood transfusion, haemorrhage, blood loss, anemia, days of bleeding, pain relief, pelvic infection, cervical damage, digestive disorders, hypertensive disorders, duration of stay in hospital, psychological effects, subsequent fertility, patient satisfaction and costs.

Search strategy: The primary source of studies was the Pregnancy and Childbirth Group's Specialized Register of Controlled Trials. The Cochrane Controlled Trials Register was also searched. Hand-searching were performed and meeting abstracts were searched. Selection criteria: Randomized or quasi-randomized clinical trials comparing medical treatment with another treatment, placebo, or no treatment for miscarriage were considered. Data collection & analysis: We extracted population characteristics, settings, and exclusion criteria, in addition to outcomes (if available) such as miscarriage not complete, death; serious complications (e.g. uterine rupture, uterine perforation, hysterectomy, organ failure, Intensive Care Unit admission), additional surgical evacuation; blood transfusion; haemorrhage; blood loss; anemia; days of bleeding; pain relief; pelvic infection; cervical damage; digestive disorders; hypertensive disorders; duration of stay in hospital; psychological effects; subsequent fertility; patient satisfaction; and costs.

Main results: Surgical evacuation of retained products of conception (ERPC) versus oral misoprostol: More patients required analgesia for pain relief in misoprostol group (Odds Ratio [OR] 5.96, 95% Confidence Interval [CI] 3.53, 10.06). There were no statistically significant differences for the other outcomes measures. There were no statistically significant differences for the outcomes considered when comparing intramuscular methotrexate plus vaginal misoprostol versus vaginal misoprostol alone. Administration of vaginal misoprostol was better than expectant management only for the outcome miscarriage not complete (OR 0.23, 95% CI 0.08, 0.66). Oral and vaginal misoprostol were equally effective for all the considered outcomes, except for diarrhoea which was significantly more frequent in oral misoprostol group compared to vaginal administration of misoprostol (OR 7.55, 95% CI 4.25, 13.42).

Reviewers' conclusions: Misoprostol is an effective and safe alternative for the management of the first-trimester miscarriage. Rates of success (complete abortion) are high and complications are unfrequent, as well as side effects, but the use of misoprostol may be limited by economic reasons. Even if an additional surgical procedure has to be performed, misoprostol has demonstrated to be helpful to open the external os of the cervix, reducing the risk of uterine perforation. Additional research are necessary in order to evaluate the economic implications of the use of misoprostol, some other important outcome measures, the optimal dosage and route of administration, long term outcome such as subsequent fertility and the management of miscarriage after 13 weeks of pregnancy.

[P40] The Effectiveness of Exercise Based Interventions for Patients with Coronary Heart Disease: Systematic Review and Meta-Regression of Randomised Controlled Trials

Rod Taylor[1], Hussein Noorani[2], Allan Brown[2], Jim Stone[3], Becky Skidmore[2]

1West Midlands Health Technology Assessment Group (WMHTAG), Department of Epidemiology & Public Health, University of Birmingham, UK; 2Canadian Coordinating Office for Health Technology Assessment (CCOHTA), Ottawa, Canada; 3University of Calgary, Calgary Canada.

Objectives: (1) To update the Cochrane systematic review of the effectiveness of exercise based cardiac rehabilitation in patients with coronary heart disease (CHD) (Jolliffe et al, 2001) (2) To use meta-regression to explore the impact of patient characteristics, intervention characteristics and trial quality on treatment effect.

Methods: Searches were undertaken on a number of electronic databases (from 1st January 1999 - end date of previous review) and bibliographies of included studies. Grey literature was sought through searches of specialist rehabilitation and health technology assessment sites and contact with experts. Randomised controlled trials (RCTs) were included for review if they included patients with CHD, employed an intervention that included exercise training and assessed outcomes that included mortality, morbidity, coronary risk factors and health related quality of life (HRQoL). Two independent reviewers undertook decisions on inclusion of studies and assessment of trial quality.  In addition to meta-analysis. meta regression was undertaken using pre defined patient characteristics, intervention characteristics and trial quality.

Results: An additional 15 RCTs were identified, contributing to a total of 35 RCTs – 14 trials of exercise as a single intervention (EX) and 22 trials where exercise is a component of comprehensive cardiac rehabilitation (CCR).  EX and CCR trials were pooled separately. EX, but not CCR, trials reduced total mortality (RR, 0.74, 95% CI, 0.59 to 0.98; RR 0.87, 0.74 to 1.02) while both EX and CCR reduced cardiac mortality (RR 0.73, 0.56 to 0.96; OR 0.80, 0.65 to 0.99). Significant reduction was observed in total cholesterol (WMD, –0.71, -0.83 to –0.60 mmol/l), LDL cholesterol (WMD, -0.52, -0.82 to –0.22), triglycerides (WMD, -0.27, -0.45 to –0.09), systolic blood pressure (WMD, -3.5, -6.1 to –0.9) and smoking cessation (RR 0.73, 0.56 to 0.95) in CCR trials. There was no significant benefit in these risk factors with EX trials. Although not pooled, there was evidence of a consistent improvement in HRQoL across the 10 trials reporting this outcome. Meta regression revealed that the beneficial effects of exercise based cardiac rehabilitation on total mortality were independent of patient characteristics (i.e. age, sex & CHD indication), intervention characteristics (i.e. duration, ‘dose’ & timing post cardiac event, dose of exercise) and trial quality. .

Conclusions: This updated review confirms that exercise-based cardiac rehabilitation improves both mortality and coronary risk factors and also indicates that it may have a positive effect on patient’s HRQoL. Paradoxically EX trials appear to reduce mortality but do not influence risk factors while CCR trials have the opposite effect.  Meta-regression revealed no evidence that benefits are restricted to any particular subgroup of CHD patients or characteristic of exercise training such as dose or timing.

Reference

Jolliffe J, Rees K, Taylor R, Oldridge N, Thompson D, Ehrahim S. Exercise-based rehabilitation for coronary heart disease. Cochrane Database Syst Rev. 2001;(1).

[P41]  Effectiveness of Interventions for Opiate Withdrawal: An Overview of the Cochrane Systematic Reviews.

Ferri Marica, Amato Laura, Davoli Marina,  Vecchi Simona, Perucci Carlo A.

Department of Epidemiology,  Rome E Health Authority, Via di S.Costanza 53, 00198 Rome, Italy

Introduction: Several pharmacological agents have been used as detoxification agents to ameliorate opioid withdrawal symptoms. The Drugs and Alcohol Cochrane group published 5 reviews  on different pharmacological detoxification treatments.

 Objectives: To provide an overview of the reviews focused on treatments for opioid withdrawal.

Methods: Results are summarised across the reviews for homogeneous comparisons and outcomes.

Results: The total number of studies included in the original reviews is 37, with a total of 2498 participants (range 20 – 200) and 43 comparisons: 12  tapered methadone versus adrenergic agonists; 2 tapered methadone versus other opiod agonists, 6 different modalities of methadone detoxification programs, 4 buprenorphine versus adrenergic agonists, 5 different adrenergic agonists, 3 adrenergic agonists versus naltrexone , and 2 adrenergic agonists with placebo. The remaining 9 were single comparisons which could not be summarised. The outcomes were: withdrawal symptoms, retention in treatment, completion rate, relapse rate, side effects.

Results on withdrawal symptoms could not be summarised because the studies used different and not comparable scales; results on urinalysis as well could not be summarised because they are differently reported and mainly based on tests rather than patients.

Tapered doses of methadone are more effective than adrenergic agonists for retention in treatment [RR 1.51, 95% CI 1.00 -2.27], completion of withdrawal [RR 1.26 95% CI 1.06 -1.49], completion rate [RR 1.11 95% CI 0.85 -1.43] and  relapse rate [RR 1.25 95% CI 1.00 -1.56]. Methadone controlled early withdrawal symptoms more adequately than adrenergic agonists. When compared with opioid agonists, methadone is more effective on completion rate and withdrawal symptoms. Improvements in the methadone withdrawal response could be achieved trough more information, counselling, and a combination of contingent payment with verbal feedback. Buprenorphine appears to have an advantage over clonidine avoiding the side effect of hypotension; there are no significant differences in any parameter for withdrawal managed with lofexidine compared to clonidine.. The results of completion rate are in favour of the treatment clonidine +naltrexone [RR 1,22 95% CI 0.98 -1, 51] versul clonidine alone. Patiens treated with adrenergic agonists have less withdrawal symptoms and higher rates of completion than subjects treated with placebo.

Conclusions: Despite a considerable number of trials have been carried out on this topic, only a few can be incorporated in a pooled quantitative analysis because of a great heterogeneity. One of the most important outcome, the withdrawal symptoms and signs could not be analysed because of the great variability of the scales used in the primary studies and of the way in which results are reported. The same problem applies to urine test results. Findings from this overview suggest that methadone detoxification has higher completion of withdrawal and retention in treatment and less side effects compared with other treatments. However, other important outcomes could be considered only narratively. The following step could be to define which other relevant research questions should be addressed, and which is the most appropriate study design to answer these questions.

[P42] Acupuncture for Acute Stroke

Shihong Zhang, Ming Liu, Kjell Asplund, Li Lin.  Dept of Neurology, West China Hospital, Sichuan University, Chengdu 610041, China. 

Objectives: The aim of this review was to assess effectiveness and safety of acupuncture in patients with acute stroke.

Methods: A Cochrane systematic review of randomized and quasi-randomized trials of acupuncture started within 30 days of stroke onset, compared with placebo / sham acupuncture or open control in patients with acute ischaemic and / or acute haemorrhagic stroke.

Results: Thirteen trials involving 1102 patients were included. All trials included patients with only ischemic stroke except one also included a small number of patients with hemorrhagic stroke (< 8%). Only two trials using sham acupuncture as control were of relatively high quality. At the end of follow-up there was a non-significant trend towards fewer death or dependency (odds ratio [OR] 0.70, 95% confidence interval [CI] 0.43 to 1.13) and fewer number requiring institutional care (OR 0.52, 95% CI 0.21 to 1.28) in acupuncture group than in control group. There was no significant difference in the mean change of global neurological deficit score during treatment period (standardized mean difference 0.72, 95% CI -0.41 to 1.85) or at the end of follow-up (standardized mean difference 0.03, 95% CI –0.37 to 0.43) between groups. The reported adverse events of acupuncture appeared to be rare (4/317, 1.3%). One trial targeting to recruit 800 patients with acute ischemic stroke is ongoing in China which compares acupuncture plus routine treatment with routine treatment alone.

Conclusions: Acupuncture appears to be a safe treatment but currently there is not enough evidence to conclude that it is effective in the treatment of acute ischemic stroke. There is no randomized data on acupuncture for acute hemorrhagic stroke. Further trials with enough sample size and scientifically sound methodology are required.

Poster session B

[P43] Systematic Reviews in Dermatology on the Map: You Are Here

Robert P. Dellavalle, Eva R. Parker, Victoria Diba, Hywel C. Williams, Lisa M. Schilling, Departments of Dermatology, Medicine, and Preventive Medicine and Biometrics, University of Colorado School of Medicine, Denver, Colorado, USA

Objectives: The utility of systematic reviews in dermatology has been questioned due to the impression that these reviews frequently find insufficient evidence to guide therapeutic recommendations.  The aim of the study was to determine the number of systematic reviews addressing topics in dermatology and the percentage of these reviews finding sufficient evidence to guide clinical decision-making.

Methods:  Computerized searches and analysis of the systematic reviews in the Cochrane Database of Systematic Reviews (CDSR) and the Database of Abstracts of Reviews of Effectiveness (DARE). Systematic review database entries were categorized as a) finding sufficient evidence, b) finding insufficient evidence or c) indeterminate to inform clinical decisions.

Results:  Three percent of all systematic review database entries in the Cochrane Library 2001, Issue 4 (54/1235 in CDSR and 65/2208 in DARE) were deemed relevant to dermatology. Fourteen relevant entries from DARE were in the process of being written and not available for further evaluation. Forty percent (42/105) of the remaining entries found sufficient evidence to assist patient care decisions. Topics related to the ten most common dermatological diagnoses were addressed in 30% (31/105).  Thirty-two percent of these entries addressing common dermatology diagnoses topics (10/31) found sufficient evidence.

Conclusions:  Although few entries in systematic reviews databases address dermatology topics (3%), entries address many of the top ten dermatology diagnoses (8/10) and frequently find sufficient evidence to inform clinical decisions (40%).

[P44] Bed Rest after Uncomplicated Acute Myocardial Infarction: Is it Any Good? A Systematic Review

Fabian Waechter, Harald Herkner, Jana Thoennissen, Marcus Müllner, Department of Emergency Medicine, University of Vienna, Vienna, Austria

Objective: The aim of this study was to determine whether there is evidence for the clinical impact of bed rest after uncomplicated myocardial infarction. Growing economic pressure has led to short period bed rest recommendations (12-hour) in the guidelines of leading cardiology associations (European Society of Cardiology, American Heart Association and the American College of Cardiology). These recommendations seem to be more consensus-based than evidence-based.

Methods: We performed a systematic review looking at randomised and quasi-randomised controlled trials. Studies were eligible if patients met predefined criteria of an uncomplicated myocardial infarction. The intervention looked for was bed rest and patients had to be allocated to a period of either short or prolong bed rest and the main outcome measures had to be reported in absolute numbers. We searched Medline (1966-12/2001), EMBASE (1988-11/2001), Evidence Based Medicine 1974-9/2001, PASCAL BioMed (1996-10/2001) and Psych Info (1966–12/2001) using Winspirs and we searched the Cochrane Controlled Trial Register. Predefined search terms were used. We also looked trough relevant textbooks published after 1985 and papers selected from relevant references. There was no language restriction. The main outcome measures were mortality, reinfarction, angina pectoris or thromboembolic events. Two reviewers extracted data independently and disagreement was solved by discussion. A funnel plot was drawn to check for publication bias.

Results: 5 randomised and 10 quasi-randomised trials were included. The majority of these trials were published in the 1970s, the latest being published in 1989. There was a short bed rest group (2 to 12 days)  with 1332 patients and a prolonged bed rest group (5 to 28 days) with 1326 patients. Mortality, reinfarction, angina pectoris or thromboembolic events were comparable between studies with a longer period of bed rest versus short bed rest. Study quality was generally unsatisfactorily (10 trials only quasi-randomised, only 3 mentioned blinded assessment of outcome and only 1 explicitly mentioned intention-to-treat analysis). The trials were underpowered to detect clinically meaningful differences. Publication bias was not very likely. We did not combine the results quantitatively as there was clinical heterogeneity in terms of duration of bed rest.

Conclusions: The evidence we found is not sufficient to inform clinical practice: the study quality was generally poor and treatment of acute myocardial infarction since publication of the latest trial has changed immensely. Thus it is unclear if bed rest after uncomplicated myocardial infarction helps to prevent complications such as early mortality and reinfarction.

[P45] Effect of Pacing Mode in Patients with Antibradycardia Pacing –

a Meta-analysis after CTOPP Trial Does not End the Controversy

Pawel Zagozdzon, Department of Hygiene and Epidemiology, Gdansk University School of Medicine, Gdansk, Poland

Objective: Pacemaker therapy is widely recognized as effective treatment of symptomatic bradycardia. Older pacing technology enabled pacing of right ventricle only. Recent dual-chamber pacemakers can sense the activity of, and pace, both the atrium and the ventricle and thus are more physiologic than older ventricular pacemakers. Retrospective studies reported that physiologic pacing compared to ventricular pacing reduces development chronic atrial fibrillation, stroke and cardiovascular mortality in patients with sinus node disease or complete heart block. Randomised prospective studies (including large trials) testing hypothesis on benefits of physiologic pacing on mortality did not yield conclusive results. Meta-analyses are now widely used to provide evidence to support clinical decision making or to show the need for further research. The aim of this study was to assess the influence of pacing mode on survival and risk of atrial fibrillation in patients with atrioventricular block or sinus node disease.

Methods: Studies were selected using  MEDLINE database and expert’s consultations. Results of five randomized, controlled trials that were published (the New England Journal of Medicine, the Lancet, the Circulation) or announced (NASPE conference) were included into analysis. Data were extracted from published materials and odds ratio for death from all causes and for incidence of atrial fibrillation were calculated. A random-effects model was used to quantify the average effects of physiologic pacing (defined as atrial or dual-chamber pacing) on survival and on risk of atrial fibrillation.

Results: There was a highly significant heterogeneity between studies’ results (p<0.0001). In five trials (5408 patients) the effect of physiologic pacing was associated with odds ratio 0.73 (95 % confidence interval, 0.64 to 0.83) for death from all causes. Analysis of patients with sinus node disease revealed more benefits of physiologic pacing compared to ventricular pacing: odds ratio 0.62 (95 % confidence interval, 0.5 to 0.79). Odds ratio related to physiologic pacing calculated only for patients with atriovevtricular block (data from two studies) was not significantly associated with better prognosis: odds ratio 0.85 (95 % confidence interval, 0.61 to 1.19). Assessing the risk for atrial fibrillation for all patients physiologic pacing was also associated with better outcome (odds ratio 0.8 (95 % confidence interval, 0.74 to 0.87).

Conclusion: These results support a general recommendation to use physiologic pacing in the treatment of symptomatic sinus node disease. However, results from this meta-analysis are not in accordance with the results of the largest trials CTOPP (The Canadian Trial of Physiologic Pacing, 2568 patients) and MOST (Mode Selection Trial in Sinus Node Dysfunction, 2010 patients) that showed small or even no benefit on survival. Further long-term studies of the effects of physiologic pacing on mortality and morbidity may clarify the disagreements as to the role of more advanced pacing technology in the treatment of complete heart block and sinus node disease.

[P46] Systematic Review of Randomized Controlled Trials of Long Acting β22-agonists for Maintenance Treatment of Stable Chronic Obstructive Pulmonary Disease

Vijay K. Shukla, Don Husereau, and Michel Boucher

Canadian Coordinating Office for Health Technology Assessment, 110-955 Green Valley Crescent, Ottawa, Ontario, Canada

Objectives: To critically examine, using best evidence synthesis methodology, the use of long acting β2-agonist (salmeterol and formoterol) agents versus placebo and anticholinergics with or without short acting β2-agonist agents, for the maintenance treatment of chronic stable COPD. Before starting the study, the trend in utilization of long acting β2-agonists and ipratropium bromide was evaluated using data supplied by Intercontinental Medical Statistics (IMS).

Methods: Published and unpublished literature was obtained by searching multiple databases (from January 1974 to December 2001) , hand searching selected journals,documents and the bibliographies of selected papers, and by contacting manufacturers. All published and unpublished prospective studies of 34 wk duration, of both parallel and crossover design, were included in the review if they included patients with (a) FEV1 75% or less than predicted, and FEV1/FVC less than 70% predicted; and (b) less than 15% reversibility of FEV1 after a dose of a short acting β2-agonist. Two independent reviewers undertook the decisions for inclusion of studies and assessment of trial quality. Two reviewers independently extracted data– including FEV1, peak expiratory flow rates (PEFR), six minute walk test, quality of life, dyspnoea measurements, number of exacerbations and rescue salbutamol use.

Results: According to IMS data from 1996 to 2001, the recommended use of salmeterol and formoterol for COPD increased 1150% and 1975%, respectively, while recommendations for ipratropium bromide for COPD decreased by 37%. Our systematic review identified 64 potentially relevant studies, with 8 studies satisfying our inclusion criteria. Five studies compared salmeterol and placebo, two-compared salmeterol, ipratropium bromide and placebo, and one compared formoterol, theophylline and placebo. A quality assessment of these studies by the Jadad scale showed that five were of moderate quality (quality scores: 3) and three were of low quality (quality scores: 2). None of the outcome measure data were suitable for pooling. Compared to placebo, salmeterol significantly increased in FEV1 (absolute value) in four studies and formoterol significantly increased FEV1 compared to placebo in one study. A significant decrease with salmeterol compared to placebo was observed in additional day time night time rescue bronchodilator in two studies.  No significant improvements in PEFR, distance traveled in a 6 min walk test, transition dyspnea index (TDI) scores or incidence of exacerbation of COPD were observed with salmeterol versus placebo in any of the studies.  Studies comparing salmeterol and ipratropium bromide did not show any significant difference in improving FEV1 and TDI scores.

Conclusion: Although utilization of long acting β2-agonists for the treatment of COPD has increased exponentially in the last 6 years, evidence of their superiority over traditional agents like ipratropium bromide is still lacking. The high cost of long acting β2agonists compared to ipratropium bromide suggests that long acting β2-agonists might be best used as second line agents for treatment of COPD.

[P47] The Symptomatic Treatment of The Cough in Whooping Cough

Victoria Pillay, George Swingler, University of Cape Town, Cape Town, South Africa

Background: There are between 20 - 40 million cases of whooping cough annually world-wide, 90% of which occur in developing countries, resulting in an estimated 200 - 300 000 fatalities each year. Much of the morbidity is due to the paroxysmal cough. Corticosteroids, salbutamol (a beta2 -adrenergic stimulant), and pertussis-specific immunoglobulin have been proposed as standard treatment for the cough. Antihistamines have also been administered.  No systematic review of the effectiveness of any of these interventions or others have been performed.

Objective: In this systematic review we aim to assess the effects of interventions to suppress coughing paroxysms in whooping cough.

Methods: Randomised and quasi randomised controlled trials of any intervention suppressing the cough in whooping cough; excluding antibiotics and vaccines. All interventions aimed at suppressing the cough in children or adults with whooping cough with any of the following outcome measures; i) frequency of paroxysms of coughing (our primary outcome), ii) frequency of vomiting, iii) frequency of whoop, iv) frequency of cyanosis, v) development of serious complications, vi) mortality from any cause, vii) side effects due to medication, viii) admission to hospital, ix) duration of hospital stay. We searched the Cochrane Controlled Trials register, Acute Respiratory Infectious Disease Group Specialised trials register, MEDLINE, LILACS, scanned reference lists of identified trials, contacted authors of identified trials and the relevant pharmaceutical companies. Studies were selected, quality assessed and data extracted by two reviewers independently. Effects were expressed as mean differences or in meta analysis as weighted mean difference s with 95% confidence intervals.

Results: Nine studies satisfied the inclusion criteria but four had insufficient data for further meta - analysis of our pre-specified outcomes.  Studies were old and poorly reported.  The largest study had a total sample size of 49 and the smallest study nine.  All studies were performed in industrialised settings.

Eligible studies assessed diphenhyramine, pertussis immunoglobulin, dexamethasone and salbutamol.  No statistically significant benefit was found for any interventions.  Diphenhydramine was associated with a mean increase of 1.90 coughing spells per 24 hours [95%CI –4.66; 8.46] and pertussis immunoglobulin a mean decrease in hospital stay of 0.70 days [95% CI -3.79; 2.39], and a mean reduction of 3.10 whoops per 24 hours [95% CI –6.22; 0.02].  Dexamethasone resulted in a mean decrease in hospital stay of 3.45 days [95% CI –15.34; 8.44] and salbutamol in a weighted mean decrease in coughing paroxysms of 0.95 per 24 hours [95% CI –6.21; 4.31].

Conclusion: Fairly reliable assessments have been performed on diphenhyramine, pertussis immunoglobulin, dexamethasone and salbutamol, yet insufficient evidence exists to draw conclusions about the effects of any of them.

[P48] PsiTri – A Survey of the State of the Mental Health Trials

EU-PSI Consortium, EU-PSI Office, Dept. of Psychiatry, University of Helsinki, PL 590, FIN-00029 HUCH, Finland

Objective: PsiTri is a new web-based database of randomised or possibly randomised trials on treatment, prevention and improvement of mental health and behavioural problems and conditions. The study-based PsiTri is derived from the specialised registers of five Cochrane Mental Health Groups; Cochrane Dementia and Cognitive Improvement Group, Cochrane Depression Anxiety & Neurosis Group, Cochrane Developmental, Psychosocial and Learning Problems Group, Cochrane Drugs and Alcohol Group, and Cochrane Schizophrenia Group. PsiTri is the first product of the EU-PSI project funded by the 5th framework of the European Commission. The objective of this survey is to present descriptive data on the content of the pooled trial database.

Methods: The PsiTri database at www.psitri.helsinki.fi was surveyed March 15, 2002, when the first 3,738 trials had been included in the database.

Results: 85,0 % of the trials have been classified as RCTs (randomised controlled trials) according to Cochrane criteria. A vast majority (93.0 %) of the trials had recruited adults only. The median number of participants randomised was 49 (interquartile range 26-91). 70.4 % of the trials were performed in a double-blind fashion, and 57,4 % reported on drop-outs or withdrawals.

Conclusion: Although this preliminary dataset may not be totally representative of the final dataset to be collected, these data highlight the need for more mental health trials in children, adolescents, and elderly. The data also illustrates the magnitude of the problem of underpowered RCTs in psychiatry, as well as the need for further training of trialists to increase the use of blinded assessments and the need for considerable improvement of drop-out reporting. On the other hand, the PsiTri register shows that an impressive volume of randomised mental health trials exist and underscores the need for a more effective dissemination of mental health intervention research.

[P49] Blood Pressure-Lowering Efficacy: A Family of Systematic Reviews of Different Classes of Antihypertensive Drugs

Gurdial S. Mattu, Michelle M.Y. Wong, Marco I. Perez, Balraj S. Heran, Vijaya Musini, M. Cremona Ticea, James M. Wright, Department of Pharmacology and Therapeutics, University of British Columbia, Vancouver, Canada

Objective: Our group of 7 reviewers are conducting 10 systematic reviews in order to determine the effects of the major classes of antihypertensive drugs (alpha blockers, angiotensin converting enzyme inhibitors, angiotensin II receptor blockers, beta blockers, calcium channel blockers, loop diuretics, thiazide diuretics, nitrates) on blood pressure reduction and withdrawals due to adverse events, in various clinical settings.  Similar trial inclusion criteria and methods of analysis are being used to develop these reviews in a concerted fashion.  This family of systematic reviews aims to assist clinicians in choosing appropriate pharmacological interventions and doses to lower blood pressure efficiently.  Our approach exemplifies the Cochrane principles of collaboration and building on the enthusiasm of individuals.

Methods:  At a weekly forum involving all reviewers, methodologies, difficulties and critical issues associated with each review are discussed and resolved by consensus.  This process maximizes transparency, openness, and cooperation.

Results: The advantages of being involved in such a collaborative setting are manifold.  The reviews have been carried out in a staggered fashion and our methodologies have evolved as new members have joined at different stages.  As a group we have developed a common search strategy with higher yield compared with the standard Cochrane search.  We have also established appropriate time windows for extracting data from studies, a hierarchy for imputing standard deviations of blood pressure changes, and the necessity of a placebo group in determining the dose-response of individual drugs.  Data verification is also streamlined by developing standardized templates and cohesive partnerships.

Conclusions: In a collaborative group setting, performing systematic reviews of different drug classes using the same outcomes is an efficient and beneficial process.

[P50] Earlier Health Technology Assessment of Dying Patients’ Therapy Baseline Reports

TAO Tie-jun [1,2], KUANG Pu[3], YAO Xun[3], LI You-ping [1,2]

Lab of Transplant Engineering and Transplant Immunology, West China Hospital,  Sichuan University 2, ta bort plassChinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, 610041, China 3 ta bort plassWest China Clinical School of Clinical Medicine, Sichuan University

Objective: Health services focus on improving, prolonging and saving lives. The earlier research indicated that end-stage care is inferior to prophylactics or timely care in terms of cost-effective, especially in the end of life. This earlier health technology assessment is to assess therapies for dying patients in terms of effectiveness, safety, ethics and health economics.

Methods: At present, there is no internationally recognized definition of dying patients from the perspective of medicine. Based on related articles and objectives, dying patients referred to the patients who suffer from critical illness/terminal diseases or diseases diagnosed as the end-stage. The therapies for dyingpatients include hospice and critical care. Considering low investment by government and the high cost of health technology including operations, drugs and examinations, more attention was paid to critical care. A comprehensive search of MEDLINE, EMBase, Cochrane Library, Chinese BioMedicine Database (CBM) as well as related online resources was conducted with subject words of "critically illness", "critical care", "intensive care" and "life support care" and limiting data before Dec. 1, 2001.

Results: Few useful studies were identified, especially in dying patients' emergency care. In MEDLINE, nine hundred out of sixty thousand searched articles were clinical trails. Most of them were for end-stage treatment in hospital, such as for unconscious patients (41 studies) and nutritional support (244 studies) and few studies were identified for urgent care. Considering the clinical perspectives and ethics, it is impossible to carry out randomized controlled trials. The alternative was therefore employed, searching databases with sub-subject words such as nosocomial infection, mechanical ventilation, nutritional support and hormone application. Though different from data, all identified trials assess the outcomes with morbidity, disablement, incidence of complication.

Conclusions: It indicated that not all therapies for dying patients were adequate in terms of effectiveness, safety and health economics.  Both short-term and long-term outcomes should be taken into account. According to the baseline, assessment of Selective Digestive Tract Decontamination (SDD) is carrying out. Further study of other therapies will be performing. Considering the low quality study in Chinese, it is suggested that health administrations should provide financial support to carry out large-scale retrospective studies and prospective clinical studies when possible.

[P51] Health Technology Assessment of Dialysis Membranes

Baseline Report

Jin Liu[1,2], Rui Shi[2],  Ruijie Li[2], Jin Zeng[3], Mei Feng[1], Youping Li[1,4]

1. Lab of Transplant Engineering and Immunology, West China Hospital, Sichuan University minus mellomrommene

2. West China School of Clinical Medicine, Sichuan University

3. School of Public Health, Sichuan University

4. Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu 610041, China

Background:  Dialysis is a therapy designed to filter toxic substances from the blood of patients with kidney failure.  A dialysis membrane is a core component of this treatment.  Dialysis membranes can be made from cellulose, modified cellulose or synthetic materials, with great variance in the cost of the membranes.  As of yet, no evidence exists to indicate that synthetic materials are superior to conventional materials.

Objectives:  To assess the different dialysis membranes in terms of effectiveness, safety, social acceptance and health economics.

Methods:  All randomised or quasi-randomised clinical trials comparing the effectiveness of different dialysis membranes were included.  All safety and economic studies were included regardless of study quality. Comprehensive searches of MEDLINE (1966-2002/3), EMBASE (1984-2001/12), Cochrane Controlled Trials Register, Cancerlit (1996-2001/9), Biological Abstract (1990-1996), Life Science collection (1982-1995), Chinese Biomedical Literature Database(CBM)(1979-2001), China Journal Databases of Vip (VIP) (1989-1999), China National Knowledge Infrastructure (CNKI)(1989-2001) and Engineering Information (EI) Compendex Web (1970-1999) were conducted.  Two reviewers independently screened the identified studies, and any disagreement between them was resolved through discussion.

Results:  One systematic review, three health technology assessments and 218 controlled clinical trials (CCT) were included.  Comparisons mainly focused on the effects of synthetic and modified-cellulose membranes on patients with acute renal failure (ARF), chronic renal failure (CRF), end-stage renal disease (ESRD), renal transplantation, drug and chemical poisoning, heroin addiction and autoimmune diseases.  Fifty-six studies assessed the effectiveness of these membranes, seventy-six assessed their safety and five assessed their health economics. Effectiveness was measured in terms of mortality, life quality, renal clearance, recovery of renal function, et al.  Individual case reports detailing serious adverse reactions, such as amyloidosis, thrombocytopenia, malnutrition, anemia, cardiovascular disease and other bio-incompatibility (BICM) reactions, were also included.

Conclusions:  Our observations at this early stage indicate that much research is yet needed to adequately assess the differences between natural and synthetic dialysis membranes.  Our future research will be based upon four criteria:  the results of our initial research, the degree to which individual doctors and patients are able to discern differences in dialysis membranes, the prices of the various membranes and the currently debated ideas as to which membrane is best suited to treating which indications of hemodialysis.  Further results will be reported soon.

[P52] Nucleic Acid and Nucleotides for NutritionalSupport and Immune Regulation Therapy. An Earlier Health Technology Assessment

JIANG Hua[1] , JIANG Zhu-ming[2], LUO Bin[3],SHUAI Xiao[3],LI You-ping.[4]

1. Depart of Surgery, West China Hospital, Sichuan University, Chengdu, China, & minus mellomrommene

2. Department of Surgery, Peking Union Medical College Hospital, Beijing, China

3. 3West China Medical School,

4. Chinese Cochrane Centre, the lab of Transplant engineering & Transplant immunology of West China Hospital, Sichuan University, Chengdu, China

Objective: To evaluate the efficacy,safty and economical values of nucleic acid/nucleotides for clinical nutritional support and immune therapy.

Methods: The following electronic databases were searched: Chinese Biomedicine database (CBM),MEDLINE,EMBASE and SCI. The randomized control trials and sytematic review/Meta-analyses were identified, data were extracted by two reviewers. Applied RevMan 4.1 for statistical analyse.

Results: Forty-six randomized control trials were identified, involving nucleic acids/nucleotides for clinical nutritional support, infant feed, immune therapy. Eighteen randomized trials comparing the use of immunonutrition which comprises nucleotides with standard enteral nutrition in surgical and critical ill patients. Combined analysis indicated that the use of immunonutrition decreases infection events£¨pool OR is 0.55£¬ 95%CI[0.41£¬0.73]£¬P=0.00004£©,length of hospitalization, and the cost. Only one trial reported the effects of adding nucleotides to breast milk substitute, but there is no valuable results for clinical practice. Twenty-seven low quality trials compared the use of "immune RNA (iRNA)" with standard methods in patients with hepatitis, carcinoma and burn, combined analysis directed that there are no valid evidences to confirm the value of iRNA. We have not found any available evidences on "nucleic acids nutrients" for alleviate aging progress or improve the life quality of the aged.

Conclusions: Immunonutrition may decrease infection rates, length of hospitalization and cost in surgery and critical ill patients, but we can not affirm the role of the nucleotides in immunonutrition. No evidences support the point of adding nucleotides in breast milk substitute. There should be more studies focus on nucleotides in enteral nutrition support and infants feeding. Also, we can not affirm the role of iRNA in clinical immune regulation therapy, further studies will be needed. There are no available evidences in nucleic acids for caducity prevention and improvement of aging people's health. Consequently, we advise Chinese health officials to enhance the management for applying "nucleic acida nutrients".

[P53] Health Technology Assessment of Mifepristone and Misoprostol for Induced Abortion: Baseline Report

Yan Zou [1,2], Sheng Jiang [2], Youping Li [1,3]

1. Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, 610041, China minus space

2. West China school of Clinical Medicine, Sichuan University

3. Lab of Transplant Engineering and Immunology, West China Hospital, Sichuan University

Objectives: It is reported by WHO that about 150 thousand cases were requested for induced abortion every day, or 53 million for each year. Tietzec estimated that about one-third to half of women around the world would experience at least one induced abortion before menopausal period. At present, induced abortion was performed by operation or drugs. However, no data were found in terms of the use of the two methods for induced abortion.

This article is to assess mifepristone and misoprostol in terms of effectiveness, safety and health economics, as well as provide evidences for decision-making at the level of both government and consumers.

Methods: Meta-analysis, Systematic Review and Randomised Controlled Trials(RCTs) about mifepristone and misoprostol for induced abortions were collected by searching Medline, Embase, Cochrane Library, CBM(Chinese Biological Literature Database) and two websites (Guidelines.com and agatha.york.uk), together with hand-searching eight Chinese journals. The study quality was assessed by two independent reviewers using the Jadad Scale plus allocation concealment.

Results: Mifepristone and misoprostol are the most commonly administrated drugs for induced abortion. In terms of effectiveness, 201 RCTs or meta-analysis related to mifepristone and 195 to misoprostol  were identified. 194 studies of mifepristone adverse effects and 156 of misoprostol were collected. In studies of mifepristone, women also suffered complications from haemorrhage, cervical laceration, uterine perforation and incomplete abortion, in addition to hypovolemic shock, allergic shock, malignant trophoblastic tumor and epilepsy violent metaldisorder. In studies where misoprostol has been used to induce abortion, hypovolemic shock, allergic shock and new-born malformation (was this where the drug was ineffective in inducing abortion and the pregnancy went to term?) have been the complications. No RCTs or Meta-analysis for cost-effectiveness were identified.

Conclusion: Based on the research and from a clinical perspective, the drug side effects should be evaluated and then the effectiveness of mifepristone and misoprostol should be assessed.  There should also be pilot studies of the cost-effectiveness of drug-induced and operation-induced abortion.  Further studies are currently underway which will answer these questions.

[P54] Comparative Review of Self-Administered Questionnaires in Vertigo and Dizziness

Chassany O, Mosnier I, Bouccara D, Sterkers O, Délégation Régionale à la Recherche Clinique (Assistance Publique – Hôpitaux de Paris), hôpital Saint-Louis, Paris, France

mellomrom

Objective: Aim of this study was to compare the validity and pertinence of available questionnaires assessing symptoms of vertigo or dizziness and their impact on quality of life.

Methods: Publications were retrieved through Medline and Embase databases (1991-2000). 24 publications reporting validation of questionnaires or use of these questionnaires in clinical trials were selected. Each publication was reviewed using a methodological checklist from the ANAES (Agence Nationale d’Accréditation et d’Evaluation en Santé) and a quality of life specific checklist (1). A global score ranging from 0 to 100 (best) was given to each questionnaire, reflecting the different levels of validation (content validity, structural validity, discriminant validity, criterion validity, reliability, responsiveness…).

Results: Nine questionnaires were arbitrarily classified, according to their content, into 3 groups: essentially symptomatic questionnaires, essentially quality of life or handicap questionnaires and questionnaires assessing both symptoms of vertigo and impact. The tenth questionnaire was specific of Meniere disease (MD-POSI). Global score of validation range from 36 to 77. All questionnaires (except EEV) were self-administered. EEV scoring is based on both evaluation of patients and physicians. Major results indicate that the questionnaire cited as a reference and mostly used, i.e. DHI lacks some part of validity. Noticeably, its structural validity has been found to be quite different in 2 further studies compared to the original validation study. Reproducibility (test-retest) has been flawly assessed for a number of questionnaires, i.e. with a low number of patients and/or with a too short interval. Responsiveness, which is critical for assessing changes with therapy, has rarely been evaluated. However, the European Evaluation of Vertigo has demonstrated a large effect size of its global and subscales scores in a longitudinal study.

Conclusion: Questionnaires reviewed in this study have shown that most of them reflecting handicap or impact on quality of life are not very specific of vertigo or dizziness, or that they have validation flaws. The VHQ appears to have the most pertinent content, but its validation remains to be performed. Mixed questionnaires have the same imperfections, even if the VDI has the best validation score. Among symptomatic questionnaires, the EEV seems to satisfactory evaluate the 5 major vertigo symptoms. Self-assessment of symptoms and impact on quality of life are of greater importance in the evaluation of therapeutic strategies in the context of vertigo and dizziness. This review was not able to specify the definite specific quality of life questionnaire. For most of the questionnaires reviewed, responsiveness is unknown.

DHI        Dizziness Handicap Inventory

VADL      Vestibular Disorders Activities of Daily Living scale

ABC        Activities-specific Balance Confidence scale

VHQ       Vertigo Handicap Questionnaire

VDI         Vertigo Dizziness Imbalance questionnaire

UCLA-DQ            UCLA Dizziness Questionnaire

DFI         Dizzy Factor Inventory

VSS        Vertigo Symptom Scale

EEV        European Evaluation of Vertigo

MD-POSI            Meniere’s Disease Patient-Oriented Severity Index

(1) Chassany O, Sagnier P, Marquis P, et al. Patient-Reported Outcomes : The Example of Health-Related Quality of Life – A European guidance document for the improved integration of Health-Related Quality of Life assessment in the drug approval process. Drug Information Journal 2002; 36:209-238.

[P55] Systemic Non High Dose 2nd Line Chemotherapy for Ovarian Cancer Failing Platinum-Based First-Line Chemotherapy.

Daniel M. Spinner, Andreas du Bois [1]. German Cochrane Centre, University of Freiburg, Freiburg, Germany; 1 Department of Gynaecology and Obstetrics, Dr.-Horst-Schmitt-Kliniken, Wiesbaden, Germany

Synopsis: Ovarian cancer is the second most frequent gynaecological cancer in Western Europe and causes about 82,000 deaths per year. Using the best available front-line treatment today results in complete absence of disease in the majority of patients. Nevertheless, the recurrence rate is high and the majority of patients experience relapse and ultimately die of their disease. A systematic review is ongoing to identify and critically evaluate all existing evidence from randomised controlled trials for the effectiveness of systemic non high dose 2 nd line chemotherapy for advanced human ovarian cancer failing platinum-based first-line chemotherapy.

Background: It has been accepted for many years that patients with advanced ovarian cancer require a platinum compound, although there has been some controversy over whether or not other drugs need to be combined with platinum. Meta-analysis involving 1200 patients suggested a small but statistically significant survival advantage for combination platinum chemotherapy (Advanced Ovarian Cancer Trialist Group 1991) but in many countries, a combination based on cisplatin was considered the standard regimen. In order to avoid the toxicity of cisplatin many investigators utilised carboplatin instead because it is less emetogenic and causes less nephro-, oto- and neurotoxicity than the parent compound although it is more myelosuppressive (Rosenberg B 1985; du Bois A 1994). However, 2 nd -line treatment is strictly palliative and essentially non-curative. 2 nd -line treatment should combine both optimal tumour control and prolongation of survival. However, there is no consensus as to which is the most effective treatment for this advanced cancer disease.

Objective: (1) To assess the effect of different chemotherapy regiments used as treatment in patients with ovarian cancer failing first platinum-based front-line treatment. (2) Furthermore the relation between different outcome parameters (response rate, progression free interval, survival) will be investigated.

Methods: For this systematic review all available randomised controlled trials (RCTs) involving therapeutic interventions for the effectiveness of systemic non high dose 2 nd line chemotherapy for advanced human ovarian cancer failing platinum-based first-line chemotherapy will be analysed. The outcomes expected to be available in reports will include response to treatment, progression free survival, overall survival, duration of response and patient satisfaction. The search strategy implied will follow the Cochrane Collaborative Review Group search strategy and will include RCTs as derived from Medline, EMBASE and other electronic database searches.

Results: (preliminary) A manual search in the two largest international medical databases (MEDLINE and EMBASE), searching in selected conference proceedings and checking reference list has to be identified by the two reviewers. The systematic review is ongoing and the preliminary results will be presented at the 10th h Cochrane Collaboration Colloquium in Oslo, Norway in Juli/August 2002.

Conclusions: The results of the ongoing systematic review are expected to provide first evidence to inform clinicians and other decision-makers on the values of interventions for the effectiveness of systemic non high dose 2 nd line chemotherapy for advanced human ovarian cancer failing platinum-based first-line chemotherapy.

• Advanced Ovarian Cancer Trialist Group Chemotherapy in advanced ovarian cancer: an overview of randomized clinical trials. BMJ 1991, 303: 884 - 93 Rosenberg B. (1985) Fundamental studies with cisplatin. Anticancer Chemotherapy 55: 2303-231683du Bois A., Meerpohl H.G, Madjar H, Spinner D, Dall P, Pfisterer J, Bauknecht T (1994a) Phase II study of pirarubicin combined with cispalatin in recurrent ovarian cancer J Cancer Res Clin Oncol 120(3) 173-8

[P56] “Growing Pains”: A Critical Review of the Literature

A.Evans, S.Scutter, University of South Australia. *Cochrane Collaboration Pain and Palliative Support Group (Oxford, UK).

Background: Much has been written about the entity “growing pains” with many reports having appeared in the medical literature since Duchamp’s first paper in 1823. The uncertainty of the aetiology of “growing pains” continues to divide approaches to management of children with this condition. Theories have been espoused, definitions attempted and treatments proposed. However, there is a vast difference in the merit of the literature with respect to the research hierarchy of evidence. The aim of this poster is to present the examined literature pertaining to “growing pains” and assessment of the same with respect to the evidence it provides.

Discussion: The notion of a hierarchy of evidence is often implied but rarely specifically stated. Sackett’s levels of evidence were applied to the literature on “growing pains” to judge the conclusions for the management of patients. Sackett (1986) grades articles accordingly: 1) randomised trial with low rate of false-positive and low rate of false-negative errors, 2) randomised trial with high rate of false-positive and high rate of false-negative errors, 3) nonrandomised concurrent cohort comparisons between contemporaneous patients eg controlled single-subject, pre-post, or matched case control series 4) nonrandomised historical cohort comparisons eg nonexperimental studies, such as comparative and correlational descriptive and case studies 5) case series without controls ie case reports. All English language publications on “growing pains” were searched and reviewed using Sackett’s levels of evidence as described above.

Conclusion: Although there are more than 20 papers written about “growing pains”, there is only one randomised trial (grade 2) and one nonrandomised controlled single subject design (grade 3). The remainder of the literature, with respect to management of patients, are grade 4 or 5 in Sackett’s levels of evidence.

Implications for clinical practice and further research: Evaluation of the literature using Sackett’s levels of evidence reveals there is currently a paucity of acceptable evidence for the management of patients with “growing pains”. This poster provides a summary of the (english language) evidence available for management strategy which facilitates informed decision making by practitioners.

This review is to be repeated as stipulated by the Cochrane collaboration guidelines, such that all evidence (including non-english language) is examined and categorised by an evidence hierarchy.

References:

• Sackett DL (1986) cited in Pratt DJ (2000). A critical review of the literature on foot orthoses. JAPMA 90(7): 339-341.Baxter MP, Dulberg C (1988). “Growing pains” in childhood – a proposal for treatment. J Ped Orthop 8(4): 402-406.Williams MT (1999). Evidence-based practice – what is evidence? Abstract - 6th National Cardiothoracic Special Group Conference, Sydney.
• Bennie PB (1894). Growing Pains. Arch Ped 11(5): 337-47.

Cochrane Software

[P57] The Chinese Version of RevMan 4.1 Software

Kegang Deng, Tao Lin Chinese Cochrane Center, West China Hospital of Sichuan University, P. R. China

Objective: In order to make it easier for Chinese reviewers to publish systematic reviews in Chinese medical journals, RevMan software was partially rewritten and the user guide was translated into Chinese.

Method:

• Translated the content of RevMan’s English screen into Chinese by using special translator software (King Soft translation 2000) and manually checking the information.
• Wrote a Chinese user guide with words and pictures.
• Pilot tested the new Chinese RevMan software
• Presented the results to Chinese reviewers and gave advice on how to use the software.

Results: Chinese can be used in RevMan software and the Chinese records extracted from the Centre’s database of Chinese clinical trials can be imported into the software as references. The Chinese user guide has been tested by some reviewers and has received positive feedback.

Conclusion: It was possible to translate the RevMan4.1 software and this has been invaluable to Chinese reviewers.

[P58] A Central Cochrane Contacts Database – That Works

Jacob Riis, Rasmus Moustgaard, Monica Fischer The Nordic Cochrane Centre, Copenhagen, Denmark

Objective: To give all Cochrane entities easy access to up-to-date contact information for all members of the Collaboration.

Methods:  The management of contact details in the Collaboration will be improved in several ways. A crucial element in optimising the data quality is streamlining the flow of information so that all relevant information from entities or individuals is fed directly into a central database, and subsequently disseminated from there. Such an approach minimizes the duplication of both information and effort. Another key aspect is providing a system that is attractive to users in terms of both features and cost, which is achieved by developing the system internally.

Results: A new web-based contact management system has been developed and is currently running as a pilot project. It has demonstrated its superiority over the software tool previously used for providing central contact information (HIREx). As a consequence, the user base is currently being expanded to include all Cochrane centres, method groups and fields, as it also allows these entities to submit their modules.

Conclusion: Once fully implemented, this system will simplify tasks involving communication and administration across the entire Collaboration, as well as being a important building block in any future integrated Information Management System.

[P59] Cochrane Software Needs Assessment Survey

Mike Clarke, Monica Fischer, Julian Higgins, Tess Moore and Phil Wiffen,

for the Information Management System Group. UK Cochrane Centre, Oxford, United Kingdom.

The production of Cochrane reviews is dependent on the flow of information between a large number of people and places. Since the Cochrane Collaboration was established, several tools and systems have been developed to help with this and to facilitate the electronic production and publication of Cochrane reviews and other material. These tools and systems make up the Cochrane Information Management System. As of March 2002, this covers the review writing software (RevMan, with MetaView as its statistical component), the software used to compile information for publication in The Cochrane Library (ModMan), a contacts database (HIREx), and a comments and criticisms process. In July 2000, the Information Management System Group established a Working Group to prepare a Needs Assessment Survey to assess attitudes towards the current components of the Information Management System, development of these components and of new ones, and interlinking of the components. Following piloting in January 2001, three versions of the survey were be prepared to target separately the editorial bases of Collaborative Review Groups (CRGs), the co-ordinating bases of other Cochrane entities and individual participants in the Cochrane Collaboration. The survey was distributed during July 2001 to the contact points for all Cochrane entities and to all individuals within the Cochrane Collaboration whose contact details were available in the Parent database or had been sent to the Nordic Cochrane Centre for this purpose.

By 30 September 2001, completed surveys had been returned by 43 of the 49 CRGs. 29 completed surveys are available from the co-ordinating bases of the 36 other entities. 3833 individual surveys were distributed and 496 completed surveys were returned. Excluding the undelivered and surveys returned as “not relevant”, the response rate is 15%. The response rate from CRGs and other entities was very high and the findings for coordinating base of Cochrane entities can be assumed to be representative. Unfortunately, the response rate from individual participants is lower than had been hoped. However, several hundred individuals did respond and, in many areas, their attitudes are consistent with those of the Cochrane entities.

The findings of the survey and a series of recommendations will be discussed by the Information Management System Group and the Steering Group in March and April 2002, respectively. The main findings from the survey and the outcome of these discussions will be presented on the poster.

Consumers

[P60] Chinese Consumer Involvement in Evidence-Based Medicine: Current Status and Strategies

Mingming Zhang, Li Wang, Jing Li, Li He, Maoling Wei and the Departments of Geriatrics , Infectious Disease, etc. Chinese Cochrane Centre, West China Hospital, Sichuan University, Chengdu, 610041, P. R. China

Background: The importance of consumer participation in evidence-based medicine (EBM) is increasingly recognized in the spectrum of healthcare in developed countries, while it is just at the beginning stage and somewhat difficulty to imitative in China.

Objective: To investigate baseline data of the current status of patients in China, and thus to develop strategies to get patients involved in EBM.

Method: 300 questionnaire with 17 questions were distributed to the inpatients in the departments of neurology, geriatrics, neonatal, communication disease and endocrine disorder. As part of survey, data were collected on: 1) the information about the disease that the patients got before treatment; 2) how and in what way they to access the information; 3)the degree to learn information about the diseases; 4)treatment involvement;5) the satisfaction with the current treatment; 6)the concerns and difficulties etc.

Results: (1) basic information: 251 feedback received. Gender: 137 male and 114 female; Ages: 140 of patients are over 50; Education: 169 were only in middle school education and the rest were in higher education; (2) how much information they got before treatment: 160 learned some information about their disease and the rest knew nothing; (3) where did they get: 169 from their clinicians, 65 from medical journals and newspaper, 12 from TV and radio, 8 from Internet; (4) the way they get health information from: 179 thought it should be from their clinicians, 35 thought from medical journals, 12 thought from friends and the rest from Internet and TV ; (5) treatment involvement: 234 would like to get involved, 12 do not care much, 8 refuse; (6) the satisfaction with the treatment: 126 were quite satisfied, 108 satisfied, the rest do not; (7) the concerns: 146 concerned with the effectiveness of the current treatment, 69 concerned about the cost and 22 concerned with the quality of hospital service, the rest concerned whether the clinicians qualified enough; (8) the difficulties: 130 thought the limited time to communicate with their clinicians, 62 thought long time waiting before receiving the treatment, the rest thought the poor attitude from the clinicians and the poor conditions of the hospital.

Conclusions: Based on the above baseline data, we have created some strategies including education and training both for the clinicians and patients about EBM and Collaboration, dissemination via various media such as Centre newsletters and Chinese EBM Journals, TV and homepage for raising awareness, attending the related patients club to promote the communication between clinicians and patients, etc. Though there is a long way for us to go, we feel full of confidence that the Chinese consumer will get involved in the Collaboration.

[P61] Information Derived from Cochrane Reviews —A Health Consumer’s View

Janet Wale Cochrane Consumer Network and Consumer for Musculoskeletal Review Groups, 2 Parry Street, Claremont, Western Australia 6010.

Objective: Cochrane Reviews reliably provide good clinical evidence. This poster encourages efforts by Cochrane Review Groups to involve their consumers in considering ways of presenting their information in useful and accessible ways for a wide audience. A ‘Consumer Meta Review of Osteoarthritis’ is appended as an example of such an effort.

Methods: Examination of the present ‘state of the art’ reveals shortcomings in the manner in which information from Cochrane Reviews is currently disseminated to consumers. Reviews and their abstracts are presented in language indecipherable to many; it is not possible to find all the information pertinent to a particular condition in one document; less than useful conclusions of insufficient clinical evidence are frequently drawn from reviews. Some of these limitations have been noted in the media (Melissa Sweet, Bulletin) and may result in a failure to reference Cochrane (MyDr). Attempts to address these issues — consumer summaries for Canadian Arthritis Society WebPages, Cochrane consumer Synopses and Hot Topics — go only some of the way towards more adequately meeting the needs of consumers.

Results: A consumer-focussed meta review on osteoarthritis was prepared from Musculoskeletal Review Groups’ reviews andprotocols. The brief was to provide a comprehensive cover of the health condition, including the various treatment options, time factors where available, and adverse events in the context of the various stages of progression of the disease.

The meta review is essentially an exercise in education that is responsive to the consumer’s needs. It is empathic to a patient’s perspective, offering respectful knowledge transference. Consumers do not wish to be addressed in a manner that might be considered patronising or insulting to their intelligence, common sense and sense of self-worth. The present approach encourages collaborative decision making in partnership with health professionals. The consumer typically contributes a very different perspective on the process of a disease, on quality of life issues, on the extent and effect of medical procedures in the short and long term, and on the value of treatment weighted against possible and probable adverse events or consequences. Decisions made in partnership may differ substantially from a treatment regimen determined solely by a health professional. At the heart of this approach is the conviction that consumers have a right to know the reality of a situation and have the freedom to move away from a ‘let’s try this’ approach to a more systematic education and treatment plan that is sensitive to their individual needs.

Conclusions: Consumers who have experienced disease have their own perspective on disease. Priorities in terms of the information they desire, treatment plans and options, may differ from the perspective of those who generally prepare information or WebPages, the health professionals governing their health care, and researchers. There is a need to provide information from Cochrane Reviews in a form that is easily readable by lay people; presented with empathy and sensitivity to the subject; and provides a comprehensive cover of the topic. This transference of information has further potential impact through consumer involvement in policy-making bodies.

[P62] Survey of American Media Coverage of the Review of Mammography Trials: An Opportunity to Educate Consumers About the Risks of Detecting Ductal Carcinoma in Situ

Maryann Napoli and Helen Schiff, Center for Medical Consumers, New York, New York USA

Background: Ever since the early 1970s, the American Cancer Society (ACS) has promoted mammography screening with the message: Find a breast cancer early---the smaller, the better—and your life will be saved.  67% of American women over the age of 40 report having had a mammogram in the last two years. A survey of U.S. women in 2000 showed that they considered the high rate of false-positives to be “an acceptable consequence of screening”. However, the survey also found,  "Most women are unaware that screening can detect cancers that may never progress”. This year an estimated 49,000 American women will be diagnosed with ductal carcinoma in situ (DCIS), largely as a result of mammography screening. The majority will be treated with lumpectomy followed by six weeks of radiation therapy, and a minority will have a breast removed.
Objective: A rare opportunity to educate consumers about DCIS presented itself with the extensive media coverage given mammography screening as a result of the work of the Nordic Cochrane Centre. A review of all randomized controlled trials by Ole Olsen and Peter Gotzsche was published in The Lancet (October 20, 2001). The review raised questions about mammography’s mortality-reduction benefit and contradicted the prevailing belief that screening leads to less-drastic treatment. Overtreatment of DCIS was identified as a considerable risk of mammography screening because most cases do not become invasive. We are in the process of conducting a survey of the media coverage given this review.  We will determine how well DCIS-associated risks are conveyed to the public by the media and by policy makers.
Methods: The largest circulation news sources, including four major TV networks and National Public Radio, have been monitored since October by typing “mammography” periodically into the search engines of their Web sites. Each news item is assessed for the mammography-associated risk information imparted, both by the article/newscast itself and by the policy makers quoted within.
Results: Policy makers are prominent in the media coverage, as many try to stifle the debate over mammography's life-saving benefit because women might be “dissuaded from getting regular mammograms” and “lives will be lost”. These concerns were at the heart of a full-page ad in the New York Times, sponsored by the ACS and nine other organizations that promote screening. The media interest continues as of March 2002. Thus far, there were 121 relevant news items, including editorials, letters to the editor, and commentaries. Of those that mentioned mammography-associated risks, most left the impression that false-positives and unnecessary biopsies are the most serious. The few that mentioned DCIS gave the subject on average one or two sentences.
Conclusions:  To most consumers, the idea of a small cancer that is better off left undetected is counterintuitive. Good explanations of DCIS and its treatments are rare in the media coverage of the review by Ole Olsen and Peter Gotzsche. Policy makers are not giving consumers the risk information they need to make an informed decision whether to continue mammography screening.

[P63] Illustrating Cochrane Reviews with Narrative Clips Describing Patients’ Experiences of the Interventions

Andrew Herxheimer, UK Cochrane Centre and DIPEx, Oxford UK

Objective:Cochrane reviews are predominantly based on the data from RCTs.  The results are derived from groups and are applicable to groups, but they take little account of differences between individuals and are therefore difficult to apply to individual patients.   It is also difficult for clinicians to explain to patients how a particular intervention may affect their disease and their life.  Brief stories describing individual patients’ experiences with an intervention could help patients and clinicians to understand the range of possible outcomes more directly than is possible in Cochrane reviews as they are now.

Methods:DIPEx (Database of Individual Patients’ Experience of illness) now includes collections of experience of hypertension, prostate cancer, breast cancer and colorectal cancer (www.dipex.org).  It was demonstrated at the 9th Cochrane Colloquium in Lyon (abstract O-053, p30 of abstracts).  Each disease module summarises semi-structured interviews with a purposive sample of 40 –50 patients.  Cochrane reviews of interventions in these diseases will be illustrated by clips from interviews of people who have experienced the intervention.  The aim is to convey primarily common experiences, both positive and negative, and to describe important effects that the intervention and the disease had on those people’s lives.

At most six clips is the maximum envisaged for illustrating one review – if possible and appropriate, two positive experiences, two ‘neutral’ ones with neither positive nor negative elements, and two negative experiences.  The clips are introduced with a preamble stressing that they are only illustrations and should in no sense be interpreted quantitatively.

Results:The presentation will show examples for consideration by reviewers, CRG editors, the Consumer network and the Collaboration at large.

Conclusion:The Collaboration is invited to plan the future addition of illustrative narrative clips from patients or their carers to reviews, eg as hypertext, whenever possible.

[P64] Sharing Cochrane Consumer Synopses with University Staff and Students: Experiences from Nigeria

Godwin Nwadibia Aja, Department of Health Sciences, Babcock University, Ilishan-Remo, Nigeria

Background:The Cochrane Library and Cochrane Consumer Synopses are not always readily accessible to everyone who needs to make informed health care choices, especially in developing countries. BU News is the monthly official ‘voice’ of Babcock University in Nigeria, widely read by staff, students, parents and friends.

Objectives: To ascertain the usefulness of disseminating Cochrane Consumer Synopses through the University newsletter.

Methods: Topical health issues from the Cochrane Consumer Synopses, determined by readers, through a survey, shall be presented in the monthly BU News. A brief feedback form designed to ascertain those who read the synopses, desired to share it with others and would need further information on the topics presented will be attached.

Result: Result of the study will be presented. The study will also offer suggestions for making Cochrane Consumer Synopses available to training institutions in developing countries.   

[P65] Using High Quality Evidence Based Consumer Health Information for
Non-therapeutic Patient Advice in Germany.

Olaf Weingart, Anette Huth, Sylvia Sänger, Günter Ollenschläger. Agency for Quality in Medicine (AQuMed), Cologne, Germany

Objective: Special patient advisory centres outside of hospitals and surgeries are established in Germany since many years. Many of these organisations look for quality of medical care from different point of view. There is a lack of using quality criteria and methods of evidence-based medicine (ebm) in selecting the information. The start of implementation of ebm in the German health care system and the influence of health suppliers by promoting their methods using consumer information, gives rise to the need to use ebm criteria in advising. We plan a study about education of patient-advisers in using evidence based consumer information. This pre-survey gives an overview about the current situation and needs.

Methods: In July 2001 a questionnaire was sent out to 704 non-profit patient advisory centres (self-help groups, patient-associations, public health offices) for selecting and randomising the participating organisations for a study. In these pre-survey we assessed the following data: staff (qualification, further education); content of advice (therapeutic options, prevention, medical errors, social law); criteria for use and selection of given information; use of Internet.

Results: 231 (33.8%) gave a feed back, 204 of them have professional staff of different groups. Out of the total number of 204 organisations we found social workers in 144 organisations; physicians in 132; nurses in 53; educationalists in 45; psychologists in 29; pastoral workers in 4, and other professions in 124. 6 organisations offer no continuing education for the staff. Only 1 offers no advice for therapy, prevention or medical errors. 178 organisations use information of other self-help associations, 167 use self-created information, 156 information from medical associations, 121 commercial information, 95 information from university centres, 79 information from co-operating hospitals/physicians, and 71 other sources for the information were used. In 37 organisations ebm is one of the criteria for selecting information. External methodological criteria are used by 11 organisations, internal quality criteria by 126; in 93 the supplier is the one of the criteria. 76 organisations have no web access, 55 have their own website. The database of the German Clearinghouse for Patient Information GCPI (www.patienten-information.de) is used only by 20 organisations and known by 64.

Conclusions: Missing information about the quality criteria for good consumer information may be one cause for lack of evidence. Sending the questionnaire and additional information material about the GCPI to the patient advisory centres might be the first step. For the further promotion of quality advice the staff should be educated in using methods of ebm. Therefore AQuMed will develop a curriculum for patient-advisers. The effect of education will be evaluated in a study; this evaluation includes a module for assessing the needs of advisers who use the GCPI database in order to improve the database.

[P66]How to Bring the Evidence to the Consumer?

The German Clearinghouse for Patient Information – Objectives, Background and Procedures

Sylvia Sänger, Anette Huth, Jens Nickel, Olaf Weingart, Günter Ollenschläger. Adresse oppAgency for Quality in Medicine, Cologne, Germany

Objectives: Health information for lay people in print or electronic format are internationally recognised as useful and important tool to help individuals making health decisions. The effectiveness of such consumer health information is dependent on their quality and accessibility. As large amounts of available health information often suffer from significant shortfalls, the Agency for Quality in Medicine (AQuMed) has developed a system to assess the quality of specialised health and medical information for non-medically trained persons, and to support health professionals in producing evidence based patient information. This system involves all stakeholders in the development, delivery and utilisation of reliable consumer health information.

Methods: The DISCERN criteria are the main basis for rating medical information for lay persons and the development of reliable health care information. Based on the DISCERN criteria the AQuMed and others developed and tested the “Extended DISCERN criteria of AQuMed and Patient Forum”, taking into account the special characteristics of evidence based patient information and web based patient information. Partners of AQuMed in this process are the German Patient Forum, the Department of Epidemiology, Social Medicine and Public Health research of Hanover Medical School, the German Cochrane Centre, the Centre for Quality Management in Health Service of the Physicians’ Chamber of Lower Saxony, the Independent Patient Advisory Centre in Bremen, the Citizen Information Service of the Physicians’ Chamber of Westfalen-Lippe and the Division of Patient Information of the German Network for Evidence Based Medicine.

Results: The output of the German Patient Information Clearinghouse focus on the progeressive and further development of the DISCERN-Guidelines to ensure the methodological quality of patient information. Considered aspects are particularly clear scientific evidence, transparency in authorship and expert status and the inclusion of patients and lay people in the entire editorial process. Health information which passed all quality controls are published on the Website of the German Patient Information Clearinghouse (www.patienten-information.de). At present, the Internet-based Patient Information Service of AQuMed comprises of approximately 800 items, which have been pre-selected and appraised. These items cover fifty medical conditions and health topics. Partnerships with appropriate information providers and users have already been established and tested in specific projects.

Conclusion: To provide more evidence into health information for lay people it is essential to promote and foster the co-operation with stakeholders and partners at different levels. At the same time it is paramount to refine the instruments used to assess the quality of information gained from this co-operation. In addition, effective strategies need to be developed in order to make patients and / or consumers of health information aware of these endeavours and present the results in a user friendly and transparent way.

CRGs & Internal activity

[P67] International Activity within Collaborative Review Groups 

Claire Allen, Mike Clarke, Liz Gliddon, Cochrane Collaboration Secretariat, Oxford, UK.

Objective: The Cochrane Collaboration is an international organization.  This project assessed the international distribution of activity within Collaborative Review Groups.

Methods:  Using Issue 1, 2002 of The Cochrane Library, data were extracted from the section headed ‘Editorial information’ in the module of each Collaborative Review Group.  This repeats the exercise done for Issue 3, 2000 (18 months previously).  The data were extracted independently by the authors, crosschecked, and a single dataset was agreed. The data can be analyzed by the type of contributor (including editor, review group coordinator, trial search coordinator, consumer, referee, and reviewer) and the country in which they reside, according to their Collaborative Review Group.  If a country had not been allocated to an individual, s/he was not included. Individuals listed in more than one category or by more than one Collaborative Review Group were counted each time.

Results: Of the 49 Collaborative Review Groups, 7718 contributors were identified within 78 different countries.  This represents an increase in both the number of contributors (from 5436) and countries (from 64), since the middle of the year 2000.  The ten countries with the most contributors were UK (3081), USA (817), Australia (766), Canada (556), Netherlands (319), Italy (299), Denmark (206), New Zealand (189), Germany (167), and Spain (165).  4242 (55%) of the contributors were listed as reviewers.

Conclusions: The activity within Cochrane Collaborative Review Groups is international. The relative contribution of different countries is variable.  Additional analyses will be included in our presentation.  The spreadsheet is available from the Cochrane Collaboration Secretariat (callen@cochrane.co.uk).

[P68] Creating a Cycle of Change and Support: Quality and Productivity Improvement at a Collaborative Review Group

Sophie Hill, Megan Prictor, Judy Stoelwinder, School of Public Health, La Trobe University, Melbourne, Australia

Objectives: To increase the output and improve the quality of reviews from the Consumers and Communication Collaborative Review Group (hereafter the Group).

Methods: In June 2000, an increased level of funding was obtained for the re-establishment of the geographical base of the Group within a university setting, in response to a proposal to the Victorian Department of Human Services, Australia. The funding body targeted editorial functions and increased output as the principal basis of ongoing funding. Following appointment and training of three new staff, activities to achieve these objectives were:

Administrative: an initial review and update of all administrative procedures and Group documents; all databases checked for accuracy and consistency of information.

Quality Improvement: revision and expansion of title registration process, seeking additional information on proposed review at pre-registration stage; all new Australian team leaders trained at Australasian Cochrane Centre; a glossary of studies (all designs) developed, with diagrammatic and referenced study examples; coding scheme developed to categorise trials in Register by scope, interventions and outcomes; revision of classification of outcomes of interest to the Group.

Increasing Production of Reviews: all existing and self-nominated reviewers in membership database contacted, seeking status of interest and activities; analysis of total membership conducted, by country and topic interest; limited number of bursaries made available for protocol development by Australian reviewers; ‘orphan’ topics advertised in newsletter.

Editorial Support and Functions: two new editors, new comments and criticisms editor, and statistics adviser appointed; and regular editorial meetings held. A second stage of examining editorial processes commenced in Jan 02, with a revision of all editorial and referee guides and checklists, the clarification of communication paths, and strategies identified to increase the size, and breadth of expertise, of referee base.

Publicity and Accountability: first annual report prepared and widely disseminated - in Australia, at Lyon Colloquium, and to Group’s members; newsletter revamped and produced regularly; detailed six-monthly reports provided to funding body.

Results: The combination of all these activities has led to a marked increase in registered titles and titles in development from 4 pre-move (May 00) to 30 since move to the new base (Dec 01), with increase in Australian lead reviewers from 1 to 8 (representing 9 teams). Intensive and early input to review development has improved quality of proposals, as evidenced by greater precision of topic formulation, and demonstrated familiarity with systematic review methods.

Conclusions: Efforts to improve the efficiency and quality of editorial processes, with an initial focus on supporting local reviewers, have shown benefits in terms of new reviews, both locally and internationally. We hope to report on comparable review publication statistics in future years. Ongoing quality and productivity measures will be: 1) continuing the cycle of improvements to editorial functions and communication processes; and 2) establishing a process to set broad priorities for new titles, and identifying suitable funding sources to assist review production, and 3) developing a post-publication evaluation procedure.

[P69] Issues Facing Reviewers from Developing Countries

V Pillay, B Van Wyk. Adresse oppHealth Systems Research Unit, Medical Research Council, South Africa

Due to limited health resources, health care interventions being practiced need to be those that are known to work to free funds for other areas of need. One of principles of the Cochrane Collaboration is to promote access and ensure wide participation, irrespective of qualification, money and gender. However, this principle falls short of fulfilment when it comes to developing countries. Lack of access to the Cochrane Library is one major stumbling block for first time reviewers. This means people wanting to do a review in a specific content area will not have access to the list of priority topics made available in the Cochrane Library. While considering doing a review, the potential reviewer cannot gain familiarity with the nature and format of Cochrane reviews, or search DARE or CCTR to establish if studies have been done. One could say that they could contact the review group or the nearest Cochrane Centre. However, electronic communication or access to such facilities to do this makes this option not always possible for many potential developing country reviewers.

Cochrane reviews are traditionally built on the individual enthusiasm of the reviewers. The gap between people in developing countries and the industrialized world in terms of understanding of research methodology, having access to resources and funding for reviews, is large. We propose that the collaboration should further develop avenues to support people from developing countries who are eager to conduct reviews but lack the skills to do this.

As many conditions that currently contribute to the burden of disease in developing countries were reported in industrialized countries in previous decades, translation of foreign articles is a major contributor to cost. In our experience (Symptomatic treatment of the cough in whooping cough, V Pillay, G Swingler – unpublished) 14 studies were done in industrialized countries and were published in a foreign language. In conducting our review, this would have become not financially feasible had we not been assisted by the Norwegian, German and Italian Cochrane Centres and colleagues who spoke the language. This was only possible because we had access to internet and fax facilities. Searching the necessary databases to have an as complete literature search as possible also was a challenge. Lack of access to European databases made it difficult to do comprehensive database searches

It has also been shown that out of 923 complete reviews with 913 classifiable contact addresses for first authors, 73 were from developing countries (Prof G Swingler, unpublished data). However even this is an overestimate of the number of people from developing countries involved in reviews as many of those reviewers would have been exposed to the industrialised world via conference or educational qualification and are no longer inhabitants of developing countries.

Our experience of conducting systematic reviews was a very rewarding albeit challenging experience but we realize that many potential researchers from developing countries would be forced to prematurely abandon the process due to lack of funds and support.

Dissemination & Interaction with the World Outside of Cochrane Collaboration

[P70] The Impact of the Collaboration on China: Chinese Cochrane Centre Developing with the Collaboration

Mingming Zhang, Youping Li, Maoling Wei, Li Wang, etc., Chinese Cochrane Centre, West China Hospital ,Sichuan University , Chengdu, 610041, P. R. China

Background: The Chinese Cochrane Centre, registered with the Collaboration in March, 1999 which is the youngest center within the Collaboration, has been marching on with the development of the Collaboration since the concept of Cochrane Collaboration first came to China in 1996.

Objective: To investigate the progress and identify the weak points. To develop the strategies to keep up with the mission of the Collaboration of preparing, maintaining and disseminating systematic reviews of effects of health care intervention.

Method: To make baseline summaries including the checklist of the work items every half year to see what we have done and need to be done. To compare the Cochrane activities in the past with that of the present in various ways such as training, producing systematic reviews, trial searching, dissemination and education.

Results: Ten baseline summaries for five years were made and we found that: At the beginning of 1997, there was only one reviewer from China with one review published in Cochrane Library, now 29 reviewers with 8 completed reviews and 14 protocols and 32 titles registered. In 1997, since the first exploratory meeting for EBM held in China with 146 participants, now there are 36 workshops held with 4672 participants from 29 provinces and cities including Hong Kong. There are 80 lectures and talks given nationwide with 8000 audience. In 1996, trial searching started in only one speciality, now 35 specialities involved in this activities with 106 journals registered to the Central and 947 RCTs were included in the Cochrane Library. In 1996, there was just one article on EBM published in one Chinese medical journal, now 267 published in over 66 Chinese medical journals, which of 29 are the leading key medical journals in China. Over 10 books on EBM and Cochrane Collaboration in Chinese, one Chinese Journal of EBM and the related homepage have sprung up.

Conclusion: Although Chinese Cochrane Centre has advanced with the development of the Collaboration, still some big challenges have been existed such as effective disseminating evidence to clinicians, implementing evidence into practice, patient involvement and the urgent need of qualified EBM personal such as methodologist, information specialist to meet the huge needs of people in China.

[P71] What Blocks the Production of Cochrane Reviews in China?

Li Wang, Youping Li, Ming Liu, Jing Li, Chinese Cochrane Center, West China Hospital of Sichuan University, Chengdu, 610041,China

Objective: The production of Cochrane Systematic Review (CSR) in China is still very few since the first one was published in Cochrane Library by Chinese author Liu Ming in 1996. In order to identify the real barriers which block the production of CSR in China, and the people who would like to involve in the CSR production, we conducted a survey.

Methods: A survey had been conducted by a questionnaire in 9 workshops on CSR held around the country from 1999 to 2001. 826 medical staffs (including clinicians, researchers and medical students) from 18 provinces in China were investigated. The data was collected and analyzed by FoxPro 6.0 and SPSS 10.0.

Results: 715 questionnaires (86.6%) were collected. The trainees were mainly from the hospitals, research institutions or medical universities, over 70% of them from 25 to 45 years old, and half of them with M.D., Ph.D. or Master Degree. They only had some basic understanding about Evidence-Based Medicine (EBM), Cochrane Collaboration and CSR before the training. Their major aims to attend the workshops were to learn how to prepare the CSR. But most of them thought completing a CSR was very difficult. The major problems blocking the production of CSR were “lack of time and funds”, “hard to get information and literatures”, “language barriers”, “lack of opportunities to be trained”, “difficulty to contact with the CSR groups”, “hard to get help”, “less access to Internet” sequentially. Since above reasons, the protocols registered in Cochrane Review groups from China were very few, and the published Cochrane Reviews by Chinese authors were fewer.

Conclusions: Chinese Cochrane Center made great efforts to identify and overcome these major problems blocking the CSR production, including: searching more stable funds, training courses of CSR and data searching, improving the quality of clinical trials and Cochrane Reviews in China, establishing the published/unpublished/ongoing databases for Chinese clinical trials, promoting the international cooperation, etc. Through their 5 years very hard working, things are getting better gradually.

[P72] Chinese involvement of EBM and Cochrane activities

Li Wang, Ming Liu, Youping Li, Mingming Zhang, Maoling Wei, Chinese Cochrane Centre, West China hospital, Sichuan University, Chengdu, 610041, P.R.China

Objective: Since 3 years ago, Chinese Cochrane Centre has done much work to support people who hope to be involved in EBM and Cochrane activities, such as training, dissemination, research, evidence-based clinical practice, etc. More and more Chinese people became interested in Evidence-Based Medicine (EBM) and Cochrane Collaboration. To identify the Chinese involvement of EBM & Cochrane activities and the current attitudes & needs towards the Chinese Cochrane Centre , we conducted a survey.

Methods: A survey had been conducted using a questionnaire in participants of the workshops on EBM and Cochrane activities held by our centre in different cities around the country from 2000 to 2001. Ninety hundred fifty-five participants in 13 workshops were investigated. The data was analyzed by SPSS 10.0.

Results: The feedback rate varied from 53.2% to 98.6% (some questionnaires were not collected because of the absence of the participants at the end of the workshops). The participants were mainly from hospitals, research institutions or medical universities and health administration sectors. Of the participants, 30% to 55% had some basic knowledge about EBM before the training, which was mainly learned from related books/journals/newspapers, workshops/meetings/lectures, or Internet. Their major aims to attend the workshops were to learn the knowledge and methods on EBM (over 80%), or to find opportunities to cooperate with the Chinese Cochrane Center (from 15% to 25%). About 89.7% to 100% of the participants thought the teaching contents and teachers were “excellent” or “good”. Around 52.5% to 89.4% of the participants were satisfied with the discussion and exercise. More than 90% of the participants said the workshops was very useful and met their objectives. The workshops were thought helpful for their research (from 78 to 85%), clinical practice (about 50 to 70%), decision-making (about 15 to 25%) and teaching (around 20%). Most of them (over 90%) hope to involved in EBM & Cochrane activities, which were “getting further advanced training”, “initiating some researches on EBM”, “disseminating and teaching EBM in China”, “hand-searching and establishing database of Chinese clinical studies”, “translating the EBM and Cochrane information” sequentially. Actually, with the fund of Chinese Cochrane Centre, about 45 work groups initiated researches on Health Technology Assessment (HTA) and 29 work groups initiated researches on Cochrane System Review (CSR). Up to now, 9 CSRs have been published in Cochrane Library and 10 researches have been finished the protocol.

Conclusions:     Most Chinese participants of workshops were satisfied with the training and supports provided by the Chinese Cochrane Center. Further attention should be paid to meeting the different needs of the Chinese people towards the Chinese Cochrane Centre, and made greater efforts to encourage Chinese people to participate in the EBM & Cochrane activities more actively and effectively.

[P73] The Inspiration from Cochrane Library: A Proposal for Publishing Research Protocol in Chinese Biomedical Journals

 Xue-mei Liu,  Jian-ping Liu,  Qian Deng. Chinese Journal of Evidence-Based ,Medicine Chinese Evidence-Based Medicine/Cochrane Center, West China Hospital, Sichuan University,610041, China

Background: The Cochrane Library is famous for its high quality of evidence on health care interventions. One of its characters of the publication is that the protocols of systematic reviews were published and received peer reviewing. There are more than 1000 biomedical journals published officially in China. But the quality of these journals is not high. Only three journals were indexed by SCI(science citation index). one of the reasons is that the poor quality clinical trials published in many journals. Until now, no one biomedical journal has ever published research protocol. Moreover, Chinese biomedical editors aren’t aware of the benefits of protocol publication for improving the quality of journals.

Objective: We aims to draw Chinese biomedical editors’ attention to publishing research protocol and suggesting the way to publish protocol.

Method: We electronically searched Medline, Chinese Medical Database (CMB),Wangfang Database with the keywords of “protocol” to invest the status of publishing research protocol by biomedical journals on January 15th, 2001. And

analyzed the research results.

Result: There is no Chinese biomedical journal publishing research protocol. Lancet, The Cochrane Library and BioMed Central accept research “protocol” and publish them in electronic version.

Disscussion: Publishing research protocol plays an important role in improving the quality of both clinical trials and biomedical journals. Firstly, protocol publication before research progress may avoids methodological errors and receives comments. It is a good way to supervise the quality of clinical trials by protocol publication. Secondly, wasteful duplication of research work can be decreased. Thirdly, protocol publication can reduce publication bias and language bias. Furthermore, biomedical journals publishing protocol not only facilitates the publication of clinical trial conducted by companies but also absorbs better submission.

Chinese biomedical journals should publish research protocol in electronic version or printed version. Publication protocol in printed version can shorten the distance between developing area and developed area for obtaining information.

Thereby, Chinese Journal of Evidence-Based Medicine, which was founded by Chinese Evidence-Based Medicine/Cochrane Center, in July, 2001, sets out to publish protocols of systematic review, randomized controlled trial, key research supported by nation, prospective Meta-analysis, clinical epidemiology researches from 2002.

[P74] Grades of Recommendation from Levels of Evidence: Are You Confused Yet?

Yngve Falck-Ytter, Monika Lelgemann, David Booker, Gerd Antes. German Cochrane Centre, Freiburg, Germany.

Background: When original research is cited, levels of evidence are increasingly applied, especially in clinical practice guidelines, health technology assessment reports or other reviews. The intention is to deliver the message, that not all research study designs are created equally. Levels of evidence are often reported numerically, while an alphabetical scheme is used to formulate the strength of the ensuing recommendations. Increasingly, the use of levels of evidence is made mandatory by journals or other official bodies. Government agencies may welcome such use to increase quality of health information. For example, the French Ministry of Health recommends levels of evidence for all health-related Internet sites. However, no set international standard exists and variations of implementation are increasingly observed.

Objective: To identify various schemes of levels of evidence used and to report problems related to a non-standardised use of levels of evidence in the literature, especially in the field of clinical practice guidelines.

Methods: A pilot study was performed to identify the use of levels of evidence in journals, scientific or speciality organisations, universities, government health organisations, and by authors of literature on evidence-based medicine.

Results: At least 5 major schemes of defining levels of evidence and many minor variations were encountered. Levels of evidence ranged from 3 to 5 major levels, some with multiple sub-levels, using roman numerals or a more general approach such as ”high”, ”medium”, ”general.” Major variations were seen in the way study designs were applied to the levels of evidence. Grades of recommendation were usually stated with letters ranging from ”A” to ”C”, ”D”, or ”E.” However, since some grading included an ”against” recommendation (e.g., a ”D”), different scales could have opposite meanings, such as ”fair evidence against the intervention” versus ”expert opinion favouring the intervention.” Thus, no standard use of lettered recommendations was seen. Very often, levels of evidence were used without adequately stating the source, thus implying an existing international standard. In some instances levels of evidence were confused with, or grouped together with, levels of importance (e.g., ”…in symptomatic cholelithiasis, cholecystectomey should be performed [Grade A]. The ”A”-grade recommendation was given because of its importance, even though no good controlled trial exists”). It is particularly troublesome that such errors are then perpetuated into secondary documents, such as health web sites or consumer summaries, as seen in this example.

Conclusions: Levels of evidence are used in many different and sometimes erroneous ways. A formal study is therefore needed to examine the relationship between the definitions of levels of evidence and the formulated grade of recommendation. Sole reliance upon grading of recommendations may be problematic and therefore the scheme used should always be carefully checked. It appears inevitable that some form of standardisation, quite similar to the CONSORT statement (Consolidated Standards of Reporting Trials), will be necessary in the future to facilitate a common language of recommendations.

[P75] Clinical Practice Guidelines: The Spanish Situation

Mercè Marzo, Pablo Alonso, Mirem Fernández, Xavier Bonfill, Iberoamerican Cochrane Centre, Barcelona, Spain

Objectives: The aim of this study was to evaluate the quality and quantity of clinical practice guidelines published in Spain.

Methods: To retrieve the maximum possible number of clinical practice guidelines we conducted a search up until 28 February 2002. Firstly we looked for clinical practice guidelines sites on the Internet (web site Rafa Bravo's http://www.infodoctor.org/rafabravo/) and the sites of different Health and Technology Evaluation Agencies and the Scientific Societies. Secondly we searched Medline for possible indexed clinical practice guidelines. The authors also included clinical practice guidelines known to them that had not been identified by the search.

From the different guidelines retrieved we evaluated the following parameters: promoting institution, financial support, multidisciplinary development, systematic reviews of the literature, levels of evidence and grades of recommendation, and number of Cochrane reviews cited.

Results:  The promoting institutions that until now have published clinical practice guidelines are the Health and Technology Evaluation Agencies and some Scientific Societies on their own (Neurology, Cardiology, Surgery, Respiratory, Family Practice and Paediatric Societies) or together with the Iberoamerican Cochrane Centre (Gastroenterology and Family Practice Societies). There are also some health care providers that are currently developing their own clinical practice guidelines. Overall around 70 clinical practice guidelines were identified including some quick reference guides.

An overview of the published clinical practice guidelines shows us that only 10 of them meet the basic criteria for being considered a clinical practice guideline: multidisciplinary development group, systematic review of the literature, levels of evidence and grade of recommendation. Only a few include existing Cochrane Systematic Reviews. Another point is that only a few belong to a wider project with previous evaluation of the current practice, detection of health priorities and an implementation and evaluation plan.

Although some of the projects have been financed by the European Community (BIOMED) and national funds (Fondo de Investigaciones Sanitarias) most of the guidelines are still financed by the pharmaceutical industry.

Conclusions: To date there is no co-ordinated project in Spain for the development of clinical practice guidelines. There is a handful of initiatives and the term clinical practice guidelines is used in various ways, often including scientific material that is still closer to the classic concept of a narrative protocol, a consensus conference or to recommendations from a scientific society.  There is a need for public institutions, governments and health care organisations to get actively involved in the promotion and co-ordination of these local and national clinical practice guidelines projects.

[P76] Beyond Systematic Reviews: Other Possible Activities for the Cochrane Centres

Pablo Alonso, Mercè Marzo, Xavier Bonfill, Mirem Fernández. Iberoamerican Cochrane Centre, Barcelona, Spain

Objective: To describe the experience of the Iberoamerican Cochrane Centre in an evidence based clinical practice guidelines project in gastroenterology.
Methods: Two years ago both the Spanish Society of Family Practice and the Gastroenterology Association decided to produce clinical practice guidelines with a rigorous methodology. The previous experiences in Spain in developing guidelines had, with few exceptions, not been very successful and the approach used was generally not evidence based. The two societies asked the Iberoamerican Cochrane Centre to help them meet the standards for the guidelines project they had planned.

Results: The multidisciplinary group composed by both societies and the Cochrane Centre has so far produced two sets of guidelines that have been published at national level. The first guideline addressed the management of the gastroesophageal reflux disease and the second, the approach to rectal bleeding in a primary care setting. Both guidelines have been developed as far as possible according to the AGREE criteria and a dissemination program is taking place during 2002. Two possible systematic reviews that were needed were detected and are in the process of being registered at present. The only Cochrane review detected was also used in the process. There are three more guidelines on the agenda (dyspepsia, colon cancer screening and anaemia) and an implementation and evaluation project will soon take place.

In Spain so far there is no central institution that co-ordinates the development of clinical guidelines. This approach involving the different societies that represent primary and hospital specialists together is an alternative way of starting the co-ordination process, which can reach the highest number of practitioners and avoid duplication of effort. The results of these guidelines will reach as many as 20,000 family practitioners and gastroenterologists.

Another polemical issue is the lack of financial support for developing guidelines. This initiative lacks public funding support but financial support from the pharmaceutical industry made the project feasible. Nevertheless, this help which is recognised explicitly, did not interfere with the independence of the editorial work. 

Conclusions: The experience of the Iberoamerican Cochrane Centre has proven successful and enriching for the three parties involved and the quality of the guidelines has been generally rated high or very high. Apart from the production of clinical practice guidelines, this initiative has proven to be a very integrated and helpful way of disseminating information about the Cochrane Centres and Cochrane Library. This work has led to recognition of the need for national co-ordination of clinical guidelines development in Spain and has raised the issue of possible roles that the Cochrane Collaboration could assume in other countries that do not currently have national co-ordination.

[P77] How a Cochrane Systematic Review Changed National and International Policy and Practice

Daniel Francis, Susan Goodall, Jason Murray, Paul Glasziou, Chris Del Mar, Cochrane Acute Respiratory Infections Review Group, The University of Queensland, Brisbane, Australia.

Objective:  To document the impact of a Cochrane Systematic Review on National and International Policy and Practice.

Methods:  Broad search strategies were used to search electronic databases and the internet for relevant information.  Hand searching of medical popular press publication was undertaken.  Two authors of the review were contacted. 

Results:  In 1996, a Cochrane review entitled «Antibiotics for Acute Otitis Media» (Glasziou, Hayem, Del Mar and Sanders) was published in the Cochrane Library. At that time in Australia approximately 26.5 million prescriptions of antibiotics were written annually, equal to 24.7 defined daily doses (DDDs)/1000 population/day.  For Upper Respiratory Tract Infections (URTI’s), antibiotics were prescribed for between 57-73% of all new cases presented to general practitioners.  The Antibiotics for Acute Otitis Media review found that while the course of acute otitis media may be shortened by antibiotics, most cases will generally subside without complications.  This research, combined with other studies, generated a change in the Australian Antibiotic Guidelines in 1996 – 1997.  The guidelines were modified to state that in URTI the use of antibiotics is not routinely indicated.  By 1998/99, antibiotic use had dropped to 23.3 million prescriptions or approximately 22 DDDs/1000/day.  Antibiotics were being prescribed in only 43-46% of new URTI cases reported to doctors with 75% of cases dealt with in accordance with the Antibiotic Guidelines.  The Antibiotics for Acute Otitis Media review, along with other reviews and meta-analyses, also formed the basis for the National Prescribing Service’s (NPS) position on antibiotics in acute otitis media. The treatment of URTI’s with antibiotics has become a focal point of the NPS’s program targeted at prescribers. The Cochrane Consumer Network, which disseminates health care information to consumers published information on acute middle ear infections for children and babies in its «Hot Topics» section. The majority of information for this was obtained from the Anitbiotics for Acute Otitis Media review.  Antibiotic guidelines in the United States have also changed in line with the evidence presented in this review.  Further programs and projects have developed.  C. Cates in the UK read the review and undertook a study of a delayed antibiotic prescription program for acute otitis media.  This showed a reduction in antibiotic usage.  A randomised control trial (Little et al, 2001) was conducted with the authors concluding that a wait and see approach to antibiotic prescription for acute otitis media is feasible.

Conclusion:  Systematic summarising of high quality research has the potential to influence practice and beliefs at a patient, national, and international level. The review, Antibiotics for Acute Otitis Media, in conjunction with other research and through appropriate dissemination was followed by a reduction in antibiotic prescribing in Australia.  The limited data fails to provide evidence proving a strong association between review and the change in practice. National (Australian) and International (United States) guidelines have changed with the accumulation of evidence surrounding this review.  

[P78] Who do Cochrane Reviewers Believe They are Writing for?

Susan Goodall, Paul Glasziou, Jason Murray, Daniel Francis, Cochrane Acute Respiratory Infections Review Group, The University of Queensland, Brisbane, Australia.

Objective:  To look at a) who reviewers believe they are writing for and why; b) to elicit suggestions about the ways in which Cochrane reviews could be changed to make them more useful to the perceived target audience and c) to attempt to identify barriers that limit the perceived audience accessing the Cochrane Library.

Methods:  A survey which used both fixed response and open ended questions on: target audience, reasons that this is considered to be the target audience, usefulness of the current format of Cochrane reviews, perceived barriers to accessing The Cochrane Library, and possibilities for Cochrane Review Groups to address these barriers.  The survey was sent electronically to all 117 Acute Respiratory Infections (ARI) Review Group reviewers who had an email address recorded with the ARI Review Group.

Results:  A total of 25 surveys were returned, a response rate of 21% so far (further followup is occurring).  Two surveys are not included in the analysis: one was not completed, one was not completed in the format requested.  The respondents included 8 ARI Review Group Editors, 17 other reviewers; main disciplines listed are 12  general practice/family medicine/primary health care doctors, 6 medical specialists, 5 epidemiology/statistics both doctors and non medical; mean length of time involved with The Cochrane Collaboration is 4.6 years (range 2- 10); settings in which respondents spend the majority of their work time ranked in order of priority are academic, administration/management, primary care setting, hospital, policy, other.  The response to the question ‘whom do you consider you are writing for when you undertake a Cochrane Review?’ ranked in order of priority is doctors (average ranking 1.7), other health professionals (3.7), guideline producers (3.7), researchers (4.2), policy makers (4.3), consumers (4.9), text authors (6.2), managers and administrators (6.2), other (9.0). 

The common theme identified in answers to the question ‘why do you believe these are the groups you are writing for?’ is:  influence of evidence at the point of care will have most impact (52%).  The two major themes identified in answer to the question ‘Do you have any suggestions about the ways in which Cochrane reviews could be changed to make them more useful to your readers?’ were:  concise summaries that contain useful numbers (30%) and completeness of coverage of the topic (30%).  The themes in answers to the question regarding barriers to use of the Cochrane Library identified access (48%) with a sub group citing cost (22%),and length and complexity of reviews (30%).

Conclusions:  Most reviewers ranked active health professionals as their major target audience for reviews, and thought these would be used at the point of care. However, lack of complete coverage, the complexity of reviews and summaries, and lack of access were perceived as barriers to utilization at the point of care.

[P79] Enhancing Dissemination of Mental Health Trial Evidence - The EU-PSI Project

Pia Pörtfors, Arja Tuunainen, Kristian Wahlbeck and the EU-PSI consortium

University of Helsinki / EU-PSI Editorial Office, Helsinki, Finland.

Background: Mental health and its different aspects are important in every society. Information about the effectiveness of treatments and interventions for different mental health conditions and problems is vital, not only for the efficient management of mental health care but also for satisfying the need of valid information among everyone affected and interested. Evidence-based information within the field of mental health is out there, but getting hold of this information is often a time consuming process, requiring skills, detective work and energy from the seeker of information.

Objective: The 3-year EU-PSI project was launched in September 2000 with the main objective to enhance access to and widely disseminate trial-derived evidence of mental health treatments and interventions, as well as to improve awareness of mental health issues among professional and non-professional consumers within and outside the mental health field. To reach this aim, two mental-health-specific information resources, the PsiTri database and the Mental Health Library.

Methods: The PsiTri database combines the registers of the five Cochrane Mental Health Groups into one, freely accessible web-based database on clinical trials of treatments and interventions within the field of mental health. The registers in themselves contain the best evidence available within the scope of each group, and in combining them, PsiTri offers a comprehensive tool for accessing trial evidence within a wide range of mental health conditions, including drug and alcohol addictions, anxiety, autism, behavioural problems such as attention-deficit hyperactivity disorder and conduct disorder, cognitive impairment and improvement, dementia, depression, schizophrenia and neuroses to name a few. PsiTri uniquely emphasizes and brings forward information on the trial level – references belonging to the same trial are grouped together and linked to a specific report on different aspects of the trial, such as its design, blinding method, interventions, number of participants etc. PsiTri, which by the end of September 2003 will include information on all the trials in the Mental Health Groups’ registers, approximately some 18 000, has since November 2001 been freely available on the Internet, at www.psitri.helsinki.fi. The project is also producing The Mental Health Library, which includes the PsiTri database, Cochrane systematic reviews, health economic evaluations, other appraisals of high quality research evidence and evidence-based guidelines in mental health. The prototype of the Mental Health Library is available now in electronic form.

Participants: The EU-PSI project is co-ordinated by University of Helsinki, Finland. The other partners in the project are the Cochrane Mental Health Groups (Dementia and Cognitive Improvement Group, Depression Anxiety & Neurosis Group, Drugs and Alcohol Group, Developmental, Psychosocial and Learning Problems Group and the Schizophrenia Group), University of York (York, UK), University of Ioannina (Ioannina, Greece), Technische Universität München (Munich, Germany) and Update Software (Oxford, UK). EU-PSI is funded by the European Commission’s Quality of Life Programme and the Finnish Ministry of Social Affairs and Health.

[P80] Knowledge and Utilisation of the Cochrane Collaboration by Primary Health Care Workers in Argentina

Agustín Ciapponi, Federico Augustovski, Family and Preventive Medicine Division, Hospital Italiano de Buenos Aires, Buenos Aires, Argentina.

Objective: To explore the level of knowledge and utilisation of the Cochrane Collaboration by primary health care workers (PHCW) in Argentina, and their demographic characteristics and practice.

Methods: Cross sectional study. A survey by e-mail was sent to nearly 5000 PHCW included in the mailing of the Family and Preventive Medicine Division, Hospital Italiano de Buenos Aires, an academic primary care centre. The e-mails answers were recollected by the K-Form programme and analysed with Stata 7.0.

Results: 411 PHCW were the early respondents (2 weeks) of the survey. Two thirds were males, mean age 41.7±9.9 years, 71% were physicians, 1% nurses and 28% other activities; 84% did residency programs; 41% work in public centres, 33% in private centres and 26% in both. Sixty-four percent of the respondents worked in academic centres. Only 51% of this highly selected population knows the Cochrane Collaboration and 23% knows its Argentine Centre. In the last year, 60% never used the Cochrane Collaboration, 18% used it less than monthly, 8% monthly, 2-3 times/month in 8%, and 4% weekly. Among Cochrane users, the Collaboration solved a small part of their problems in 8%, enough in 46%, very much in 42% and completely in 4%. The sources of  access to Cochrane were: 3% subscription, 10% Obgyn, 4% OVID, 23% Medline, 12% libraries, 21% multiple sources and 31% other sources. We dichotomised the use in “frequent user” (15% of the population) if the use was more than monthly and the utility to Cochrane users in “highly useful” (46%) if the Cochrane solves problems more than enough. We explore the association between these  variables with demographic and practice variables mentioned above. Younger age was the only variable significantly associated with frequent use (3.5 years difference, 95%CI 0.07-6.8, p=0.045), and there was a tendency (p=0.073) to a more frequent use in academic centres than in the others (18% vs. 10%).

Conclusions: Knowledge and utilisation of the Cochrane Collaboration were poor even in a highly selected population of PHCW in Argentine but the utility for users was good.  Almost no users have access through a paid subscription. As this is a selected sample, the results probably overestimate users population and utilisation pattern in argentine PHCW.

[P81] Finding a Haystack Among the Needles: Making Health Promotion and Public Health Reviews in The Cochrane Database of Systematic Reviews Available to Policy Makers

Ginny Brunton, Josephine Kavanagh Elizabeth Waters, Jodie Doyle, Jonathan Shepherd, Rebecca Rees, Angela Harden, Sandy Oliver, Ann Oakley. EPPI-Centre, Social Science Research Unit, Institute of Education, London, Great Britain

Objective:  Using systematic reviews as one resource to inform health promotion and public health (HP&PH) policy can be challenging. HP&PH reviews are often difficult to locate within commercial and specialist registers. Searching difficulties will limit the acceptability and utility of reviews by HP&PH practitioners.  Search strategies need to be sensitive, requiring a combination of free text and Major Subject Heading (MeSH) terms. The purpose of this study was to determine the ease with which one can locate HP&PH reviews within the Cochrane Database of Systematic Reviews (CDSR).

Methods: A search of the CDSR (Issue 4, 2001) was conducted using ‘health promotion’ and ‘public health’ both as MeSH and free text keywords. The keyword fields of a sub-set of thirty-five randomly identified reviews were then scanned to determine if HP&PH was identified as either a MeSH term or free text keyword.

Results: A total of 487 reviews were identified. Screening the keyword field of 35 reviews indicated that only one review (3%) contained the term ‘public health’ as a MeSH term. No reviews were keyworded with ‘public health’ as a free text term, or with ‘health promotion’ as a MeSH or free text term.

Conclusions: Subsample analysis indicates that the keyword field of an estimated 3% of reviews on CDSR contain the MeSH terms ‘public health’ or ‘health promotion’. No reviews contain these terms as free text keywords. This has implications for the ease with which policy makers, practitioners or researchers will be able to locate reviews on CDSR if using ‘public health’ or ‘health promotion’ as search terms. Future work could involve tagging reviews in CDSR with these simple keywords. This application of more specific yet intuitive topic identifiers to locate public health, health promotion and disease prevention interventions will assist policymakers practitioners, and researchers to use the CDSR to its full potential.

[P82] Infections and Antibiotics: Clinical Practice Guidelines in the Real World

Axelsson I[1] , Lundborg CS, Olsson E, Mölstad S, and the Swedish Study Group on Antibiotic Use, Östersund County Hospital/Mid Sweden University, Östersund, Sweden.

Objectives: To study the use of antibiotics (ABX) in out-patients, and concordance/discordance between evidence based clinical practice guidelines and real world. Acute otitis media (AOM) in children is the most common cause for prescription of ABX and was therefore selected for a special study.

Methods: In 5 Swedish counties (population 1,29 million), all GPs, ENT doctors, infectious disease doctors, and pediatricians were invited to take part in the study. During one week in November 2000, participating physicians completed a questionnaire for every outpatient (children and adults) who presented with an infection-related complaint.

Results: We collected 5.4 forms/1000 inhabitants, covering 41% of ABX dispensed during the study week. The same amount of ABX was sold as during the other weeks in November. ABX were prescribed to 59% of all infected patients; 44% of these prescriptions were for pcV. Of all ABX (to outpatients 0-100 years), 25% were prescribed to young children (0-7.99 years). ABX were prescribed to 95% of AOM cases.

Discussion: PcV for 5 days has been the recommended treatment of AOM in Sweden during the 1990’s. A randomized clinical trial and observational studies in the Netherlands have shown that mild and moderate AOM cases >6 months old do not need ABX. One of us (I.Ax.) has therefore during the 1990’s proposed the adoption of the Dutch guidelines in 2 papers in the national Swedish medical journal (Läkartidningen) and in other journals. An average issue of Läkartidningen has 120,000 readers (1.5% of the Swedish population), incl. ~80% of the 28,000 MDs <65 years old. New national guidelines for AOM, based on systematic reviews of the literature, were finally published in May 2000 by the National Board of Health, the Medical Research Council, and the counties. According to these guidelines, ABX are not necessary in most AOM cases in 2-16 years old patients. Restrictions in the use of ABX are recommended. It is obvious that the physicians disagree; they still treat 95% of AOM cases with ABX.

Conclusions: We plan a new study week in November 2002, probably limited to GP’s since they prescribe the vast majority of ABX to outpatients. We need to discuss the disagreement regarding AOM with GPs. A possible solution may be deferred prescriptions: the parents get a prescription of ABX, but are asked to use the prescription only if the child does not improve during the next few days (BMJ 1999;318:715-6).

[P83] Dissemination: Making Cochrane Cancer Systematic Reviews More Accessible

Sally Hunt, Mark Lodge, Chris Williams, Cochrane Cancer Network, Institute of Health Sciences, Oxford, United Kingdom.

One of the objectives of developing a specialised database for cancer is to make Cochrane systematic reviews more accessible, both to patients, carers and health professionals.  Promoting the accessibility of systematic reviews is part of the mission of the Cochrane Collaboration and the fourth core function of Cochrane Fields/Networks1.  Cochrane systematic reviews are produced within a pre-defined methodology, designed to reduce the risk of bias and are often long, complicated and not easily understood by patients or other users.  Short consumer synopses are not always able to cover adequately, all the information contained in a Cochrane review.

The Cochrane Cancer Network has developed two opportunities for public and professional access to Cochrane reviews: The Cancer Library and the National electronic Library for Cancers (NeLC).

The Cancer Library contains high quality systematic reviews produced by the Cochrane Collaboration related to cancer care.  Cochrane systematic reviews already cover many aspects of cancer from prevention (e.g. smoking cessation), screening (e.g. mammography), communication (e.g. decision aids), or treatment (e.g. drug therapies for cervical cancer, radiotherapy regimes for lung cancer) through to complementary and high-tech medicine. A plain language summary of each Cochrane review setting out in a transparent format what exactly each review means has been prepared in partnership with CancerBACUP (UK).  This library also contains generic Cochrane reviews applicable to cancer, such as organisation of care and more effective prescribing. Additional features of The Cancer Library include: a regularly updated collection of other quality systematic reviews of the effects of cancer treatment, commentaries on Cochrane reviews by experts in different parts of Europe, a register of reports of randomised controlled trials relating to cancer, access to registers of ongoing randomised clinical trials in cancer research and links to other reliable, up-to-date information of interest to patients, carers and health professionals within the cancer community. This additional information helps to put systematic reviews into context for patients and other users.2 The first issue of The Cancer Library will be launched by its publishers Update Software  at the 18th UICC International Cancer Congress, Oslo, 1st July 2002.

The National electronic Library for Cancers (NeLC) is a ‘virtual branch library’ of the National electronic Library for Health (NeLH), an Internet-based initiative of the UK NHS to make evidence-based resources (including the Cochrane Library) and information easily accessible to the general public and health professionals. 3  Working jointly with Cochrane Collaborative Review Groups and consumers, the Cochrane Cancer Network has also prepared two breast cancer websites designed for both patients and health professionals, using the latest evidence-based information. (See http://www.nelh.nhs.uk/breastcancer and http://www.nhsdirect.nhs.uk/breastcancer)

The production of specialized databases and websites not only provides access to Cochrane systematic reviews, it also promotes the work of the Cochrane Collaboration within a particular area of health care and helps develop a wider understanding of the value of the work produced by Cochrane Collaborative Review Groups.

Reference:                     

Fields/Networks. The Cochrane Manual. 2001 Section 3, pp 106-122. The Cancer Library 2002 Issue 1.Update Software, Oxford UK

National electronic Library for Cancers (NeLC) http://www.nelc.org.uk

[P84] Disseminating the Findings of Research: The NHS Centre for Reviews and Dissemination Experience

Booth A, Richardson CR, Wilson PM. NHS Centre for Reviews and Dissemination, University of York, York, YO10 5DD, UK

Introduction: Basing decisions on reliable information is now a central theme of UK health policy. Clinical governance has made all National Health Service (NHS) organisations accountable for continuously improving the quality of care and services they deliver. In order to do this effectively, those individuals with responsibility for clinical governance need to draw upon the large volume of research evidence and guidance relevant to effectiveness.

The NHS Centre for Reviews and Dissemination (CRD) is charged with disseminating the results of health care research to the NHS and to users of its services. Over the past seven years we have employed a variety of methods and strategies to disseminate research findings to key audiences in health authorities, hospital trusts and primary care.

Methods: This presentation will summarise the experience of CRD in their attempts to disseminate and promote the uptake of research findings within the NHS. It will describe CRD's unique distribution system based on the principles of relationship marketing that involves maintaining active links with key individuals across the NHS. The presentation will also highlight practical issues for those involved in the dissemination of high quality research evidence.

Conclusions: CRD recognises that improving access to good research evidence does not ensure that health professionals and decision makers will be able to use it in practice. However, this should not be taken to mean that raising awareness of the messages underpinning proposed practice changes is unimportant. Whilst the relationship between knowledge and behaviour is rarely a linear one, getting the message across still plays an important part in any behaviour change process.