Methods Groups Newsletter   Volume 4 June 2000

New and pending registrations
The Non-randomised Studies Methods Group was registered during 1999. Draft modules have been prepared by the possible Training and Support, and Qualitative Research Methods Groups and these may be ready to apply for registration in 2000. In addition, the possibility that these two groups, and the one on Reporting Bias, will become joint Cochrane-Campbell Methods Groups is being explored.

Monitoring
In November 1999, a survey was sent to all Methods Groups that had been registered for more than one year (i.e. excluding Non-randomised Studies) asking them to report on their activities during 1999. This built on the checklist that had been used earlier in the year and included some additional questions approved by the Methods Group Convenors during their meeting at the Rome Colloquium. The survey was designed to cover the five general functions of Methods Groups: policy advice, training and support, empirical research, help monitoring the quality of Cochrane reviews, and a forum for discussion. All 10 groups replied by late January and a summary of the main points from their replies follows. The survey, modified as necessary, will be sent to all registered Methods Groups on an annual basis.

Policy advice
The only group that said they had been asked for advice by the Steering Group was Screening and Diagnostic Tests (although the Statistics Group noted that they had supplied advice to the Software Development Group).

Training and support
Most Methods Groups had been asked for advice or support from other Cochrane entities during the year. The number of requests ranged from none (Empirical Methodological Studies and Information Retrieval), to more than 20 (Informatics) and "lots" (Statistics). All groups that had been asked, reported that they had been able to respond satisfactorily, except for Statistics because of the lack of sufficient resources. All groups apart from Empirical Methodological Studies, Informatics, and Information Retrieval held at least one training workshop. The revision of the Cochrane Reviewers’ Handbook (leading to version 4.0 in July 1999) involved input from the Economics, Empirical Methodological Studies, Individual Patient Data, Prospective Meta-analysis, Statistics, Possible Drug Safety and Possible Reporting Bias Methods Groups.

Empirical research
As would be expected, Empirical Methodological Studies is the most active group in terms of empirical research. It has 7 methodology reviews under way and overall responsibility for the content of the Cochrane Methodology Register (see pages 20-21). All groups except Informatics and Prospective Meta-analysis have some methodology research under way and/or had organised workshops aimed at advancing methodology. However, some groups are not fully aware of the relevant methodological research being conducted by their members.

Help monitoring the quality of Cochrane reviews
Information Retrieval and Statistics reported that they had undertaken assessments of the Cochrane Database of Systematic Reviews.

Forum for discussion
All groups except Prospective Meta-analysis met at least once during 1999. Two groups (Information Retrieval and Statistics) reported that they have active email discussion lists. Informatics, Placebos, and Screening and Diagnostic Tests noted that they have lists but these might not be active.

Targets
Three Groups indicated that they had met their targets (Information Retrieval, Individual Patient Data, and Prospective Meta-analysis) for the year but, of these, only Prospective Meta-analysis gave details of what their target was (i.e. registration). Individual Patient Data was the only group to provide targets for 2000.

Recommendations

• Strategies should be developed to encourage Cochrane entities to seek advice from Methods Groups.
• Methods Groups should be encouraged to identify, conduct and report methodological research.
• Methods Groups should be encouraged to set, and publish, targets on an annual basis.
• The standardised reply for each Methods Group should be sent to their regional Cochrane Centre.

Information from the Methods Groups

REGISTERED GROUPS

Since our report in the 1999 Newsletter, health economics work linked to the Cochrane Collaboration continues to develop in many ways. The Economics Methods Group (CEMG) currently has around 80 actively interested members, with a regular trickle of new enquiries from all over the world. The three co-convenors and administrative co-ordinator, and a significant group of other willing members have found time from their other (paid) duties during the last year to co-ordinate the group, to raise funds, to organise workshops, and to plan ahead for better funded times. With no funds specifically for the Group, we nevertheless managed to organise, attend and run workshops at the meeting of the International Health Economics Association at Rotterdam in June 1999, the UK Health Economics Study Group at Aberdeen in July 1999, and at the Cochrane Colloquium at Rome in October 1999. We managed this through some redirection of consultancy and review fees, and support from our employers for time spent on this work.

At the Economics Methods Group business meeting during the Cochrane Colloquium at Rome in October 1999, we agreed we need to do more to meet our objectives on maintaining communication and on methods development. We are delighted that we have been granted funds by the Office of Health Economics in the UK for our Newsletter, which we aim to circulate during in mid-2000. We are also close to setting up a CEMG mailbase, which will be complementary to CCINFO and the Cochrane Methods Groups discussion lists.

We have also been granted funds, by the Institute of Health Economics in Alberta, Canada, for a workshop in early 2001 to prepare a book presenting the debate, the evidence, and the research questions, on economic evaluation and systematic review.

Several members of the Group had abstracts accepted for the meeting of the International Society for Technology Assessment in Health Care at the Hague in June 2000. We are planning for an introductory satellite session and at least one workshop at this years’ Cochrane Colloquium at Cape Town. We have even started discussion for meetings at the next Colloquium at Lyon in 2001.

We will continue to seek core funding for the Group, and when successful, we will be in a better position to encourage and take forward specific projects. However, we have the embryo of a register of members’ research interests and publications, which will be added to the Cochrane Methodology Register as appropriate. We are also delighted that the NHS Economic Evaluation Database (NHSEED) is now included on The Cochrane Library, and that there are already research projects underway linked to reviewing the content of that database. Cochrane reviewers who would like to compare their reviews with economic evaluations abstracted in the NHSEED can now do so, and we would be very interested in collating the results of any such projects.

At the end of July 1999, the Cochrane Collaboration Steering Group gave official approval to the Empirical Methodological Studies Methods Group (EMSMG) to function as a special type of Cochrane Review Group. This means that the EMSMG can set up a database of methodological reviews that would be published on The Cochrane Library. Like "traditional" Cochrane reviews these would be updated periodically to ensure that any newly identified, relevant studies are included.

It is proposed that the EMSMG will submit our first reviews for publication in Issue 2, 2001 of The Cochrane Library. There are now 11 reviews that are planned or already completed that will be in the new database (see pages 20-21).

A registration procedure has been developed based on the procedure used by many Cochrane Review Groups. Currently, 9 reviews have been registered with the EMSMG. As of March 2000, four sets of reviewers, which are not submitting previously published reviews, have submitted protocols: The PIRATES (Peer Review & Technical Editing Systematic review) Group led by Tom Jefferson has submitted three protocols and there has been one from the Individual Patient Data (IPD) Methods Group comparing IPD versus aggregate data meta-analyses. The TROUT Group led by Dave Sackett has submitted a summary of a proposed review on the OUTcomes of similar patients treated in Traditional vs. Randomised settings (TROUT).

It is planned that the finished reviews will be formally submitted to the contact editors in September 2000. Editing of the reviews, including feedback of comments, peer review, appropriate revision by the reviewers and final editorial approval, should take less than six months. Thus at least 7 reviews should be ready for submission for Issue 2, 2001 of The Cochrane Library.

Prior to submission of the reviews, slight modifications will have to be made in the Review Manager software (RevMan) that is used for Cochrane Reviews. This involves changing some of the titles in the software while retaining the same format for the reviews of methodology as is used for Cochrane reviews of healthcare interventions.

The aim of the Informatics Methods Group is to support the work of the Cochrane Collaboration by: (1) monitoring and evaluating the provision, accessibility and use of informatics tools; (2) assisting people in the Collaboration to access and use these tools confidently; (3) exploring ways to exploit fully the existing informatics technologies; (4) developing tools to make the handling and sharing of information within the Collaboration as efficient as possible; (5) researching how evidence about health interventions can be represented and disseminated to foster positive change in health practices and outcomes. This aim can only be achieved by working together with the Cochrane Collaboration Steering Group's Software Development Group and Update Software.

Members of the Informatics Methods Group are busy with a variety of projects:

The Contact Directory
HIREx, the software that is used for maintaining membership details, needs to be replaced. At the Cochrane Colloquium at Rome in October 1999, Tor-Arne Bertheussen agreed to circulate a draft proposal for a new Contact Directory software package for the Informatics Group's email list. This might become part of a revised Information Management System for the Collaboration. It is possible that there will be a pilot demonstration at the Cochrane Colloquium at Cape Town in October 2000. The new software will allow users and groups to change contact details themselves but, until it can be implemented, changes in contact details should be sent to contactdb@cochrane.de.

The Cochrane Collaborations Internet site(s)
The Cochrane Collaboration Internet site(s) are growing rapidly. The number of times that pages were accessed exceeded 75,000 in May 2000, at the German Internet site alone. The Internet site has been maintained by David Badger and distributed by him to the various hosts. Georg Koch agreed to redesign the site at the Rome Colloquium. In addition to "the" Internet site, more and more entities now have their own web pages. With the growing need, and because of the expertise required to develop Internet sites, the work of the Informatics Group might change its main focus. We invite everyone developing Cochrane web pages to join our Group, if they have not already.

Email lists
The email lists formerly hosted at cochrane.co.uk moved to cochrane.de at the end of 1999. Any entities who would like to develop email lists are invited to send requests to Georg Koch.

Review titles
Tor-Arne Bertheussen has developed title registration software, which will be Internet based. This will be piloted by several Cochrane Review Groups.

The Informatics Methods Group plans to meet at the Colloquium in Cape Town to discuss these issues and, hopefully, the results from a survey of all entities, which was deferred until 2000 because of the moratorium on surveys in 1999. If anyone would like to suggest other items for the agenda, or other projects that the group should tackle, please send them to the convenors Georg Koch (koch@cochrane.de) and Jacob Riis (j.riis@cochrane.dk).

The Information Retrieval Methods Group (IRMG) met at the Cochrane Colloquium at Rome in October 1999, where the focus of the meeting was to determine what the Group can do to benefit the Collaboration. We reiterated our interests in issues of information retrieval - coding and classification, indexing, and searching. There was unanimous agreement that The Cochrane Library is a great resource but that there should be improvements in its indexing and searchability. There was also discussion of how to get librarians more involved in the Collaboration, and of new initiatives to enhance usability (beyond the fixing of current problems) of The Cochrane Library, such as the addition of topic trees. The major issues discussed were:

Improving The Cochrane Library
Many people have reported problems with searching The Cochrane Library. These have been reported to Update Software.

It was agreed that the best approach would be to prepare a report for the Steering Group. If approved, this would then carry much more weight than the individual comments made to date. Furthermore, a document that had a coherent discussion would be much better than individual notes. Philippa Middleton, who is spending a year at the UK Cochrane Centre, has since produced a document (which is summarised at the end of this report) and this was accepted by the Steering Group in March 2000.

Involving librarians
The Group discussed ways to involve more librarians in the Collaboration and in our Group specifically. One approach would be to publicise ourselves and invite participation at major medical library meetings, such as the International Congress on Medical Librarianship at London in July 2000. Another suggestion was to establish contact with a group similar to ours in the Health Technology Assessment Group ISHTAHC.

Improving the Cochrane Reviewers’ Handbook
Some discussion was devoted to how the Group can improve the Handbook. One suggestion was to try to include information presented at the various Colloquia that would help people produce better reviews. An example was a poster at the Colloquium, which showed that using EMBASE plus MEDLINE for searching led to a better yield of trials than using CENTRAL/CCTR.

This led to a more general discussion on work that gets presented at the Cochrane Colloquia. Our impression is that most of this rarely gets published elsewhere. Some of the abstracts are included in the Cochrane Methodology Register, but not all, and those that are included are the abstracts from the abstract book, which often contain preliminary information compared with what gets presented at the Colloquium. Therefore we thought it important that the Cochrane Collaboration should do a better job of capturing information about presentations at the Colloquia.

Topic trees and other initiatives to enhance usability of The Cochrane Library
Philippa Middleton talked briefly about a proposal that has been circulating to develop "topic trees" for better organizing information in The Cochrane Library. She will circulate a draft by email for the Group to comment on.

Searching The Cochrane Library
In response to concern about some difficulties and inconsistencies in searching The Cochrane Library, Philippa Middleton and a small group from the IRMG prepared a paper which was discussed at the Steering Group meeting in March 2000. The full paper is available from Philippa (p.middleton@cochrane.co.uk). The main points covered by the paper were: (1) suggestions for short-term and long-term improvements to The Cochrane Library help systems, (2) the need for a better system for reporting problems and receiving feedback about the progress of fixing these problems, and (3) a list of problems with searching (e.g. difficulties in searching for authors, inability to search on MeSH subheadings and words with less than three characters).

The paper also recommended that the Cochrane Collaboration, Information Retrieval Methods Group (IRMG) and Update Software, as appropriate should:

• Establish an Internet site for bugs - covering reporting, progress and planned enhancements.
• Have official links with the Cochrane Library Users’ Group and have a nominated IRMG representative on this Group.
• Monitor the Trials Search Co-ordinators’ (TSC) email discussion list and nominate someone to be the link between TSCs and the IRMG.
• Offer to write or edit help screens.
• Identify where error messages or alerts are needed.
• Maintain better links with Update Software.
• Maintain better links with the Central/CCTR Advisory Group.
• Offer to test The Cochrane Library prepublication, and to identify who tests The Cochrane Library at present and suggest ways of systematically dividing up the work.
• Work on ways to standardise how journal titles are shown on CENTRAL/CCTR.
• Check the Internet versions of The Cochrane Library.
• Explore the idea of having a graphically based help section.
• Do comparative searches using MeSH headings on The Cochrane Library and MEDLINE.

There has been encouraging progress during the last year in including pre-existing individual patient data (IPD) reviews in The Cochrane Library. Issue 2, 2000 now includes 7 such reviews, in various cancers, that have been co-ordinated by the research groups of the Methods Group Convenors. Now that we have proved that it can be done, we will be actively encouraging other members of the Group who have conducted IPD meta-analyses outside of the Cochrane Collaboration, to convert them to Cochrane format and submit them through the appropriate Collaborative Review Group for inclusion in The Cochrane Library. Additional guidance has been added to the Cochrane Reviewers’ Handbook to help with this.

A protocol for a Cochrane methodology review has been submitted to the Empirical Methodological Studies Methods Group for peer review (see page 20). This will be carried out as a collaboration between Mike Clarke, Oxford; Lesley Stewart and Jayne Tierney, London and Paula Williamson, Liverpool. It will be a systematic review of methodological projects that have compared IPD meta-analyses with those based on other types of data.

In April 2000 we held a training workshop titled "What are individual patient data reviews?" at the UK Annual Contributors’ Meeting in Oxford. The format and content were significantly revised from previous training workshops organised by the Group. The new set of slides used at the workshop will therefore shortly replace the existing ones on

the Cochrane Internet site: www.cochrane.de/cc/cochrane/training.htm#IPD.

Two workshops will be offered for the Cochrane Colloquium at Cape Town. The first of these, which will be run jointly by the Methods Group and by the UK Medical Research Council, will be an advanced discussion workshop exploring specific types of analyses possible with IPD across a range of disease sites. The other workshop will be a training workshop similar to the one held at the Oxford meeting.

We are also establishing a register of ongoing and completed IPD meta-analyses. We would be grateful if anyone who has done or knows of an IPD review in any area of healthcare could send us details. The annual membership questionnaire will be circulated to all members of the Group in August 2000.

Following several years of pre-registration activity the Non-randomised Studies Methods Group (NRSMG) was formally approved by the Steering Group in November 1999. Since the last issue of the Cochrane Methods Groups Newsletter the following has happened:

A working meeting for contributors was held in London, 27-28 May 1999, with 12 participants from 5 countries. Basic material and examples were presented and discussed in relation to the proposed chapters for guidelines on the systematic review of non-randomised studies. An outline for the workshop to be held at the Cochrane Colloquium at Rome in October 1999 was also discussed. The final decisions regarding the workshop were taken by email and in a face-to-face meeting the day before the Colloquium.

At the Colloquium, the workshop was heavily oversubscribed, but following some "fighting" at the entrance the workshop was held peacefully. During the workshop the convenor of the Group was approached by Dr Tessa Tan-Torres Edejer from the World Health Organisation (WHO), who expressed a keen interest in the work of the Group. Collaboration between the WHO and members of the Group was initiated during the Colloquium and a proposal on a collaborative project led by Helen Thomas was subsequently funded. Members of the group also had plenary and poster presentations. A very short business meeting was held on the final day, in a room taken over by the Cochrane Collaboration Steering Group.

A working meeting for more than a dozen contributors is took place in Copenhagen, 8-9 June 2000. Before this on 7 June an open Symposium entitled "Non-Randomised Studies in the assessment of health care interventions" was held, involving several speakers from the NRSMG.

For minutes and further information please visit the NRSMG’s Internet site at www.cochrane.dk/nrsmg/.

A workshop on the placebo effect was held at the Cochrane Colloquium at Rome in October 1999. More than 40 people attended, including 7 members from the Placebo Methods Group. Asbjørn Hróbjartsson presented a systematic review of 130 trials, each of which included a placebo group and a no-treatment control group. There was no apparent effect of placebo intervention on binary outcomes or on continuous, objective outcomes. There seemed to be an effect on continuous, subjective outcomes but the estimated effect was small and reporting bias could not be excluded as the trials were not blinded. It was concluded that the placebo effect is not powerful, contrary to what has been claimed since Beecher’s paper in JAMA in 1955.¹ There was general agreement that the results of the review showed that the effect of placebo interventions had been much overrated.

Gerben Ter Riet presented the results of trials that had looked at the mechanism of placebo analgesia by using the opioid antagonist, naloxone. There seemed to be a placebo effect on pain, which was antagonised by naloxone. However, only Ter Riet’s own study had measured endorphins. As this study failed to find a placebo effect, it seems relevant to conduct further research in this area.

Peter Gøtzsche raised the question of whether a Placebo Methods Group was still needed. It was felt that, although the Methods Group was somewhat atypical in several respects, it was very important to maintain a focal point for this line of research. Of direct relevance to Cochrane reviewers is the finding that there was no placebo effect on objective outcomes. This suggests that trials that have compared an active treatment with placebo can be combined with trials that have compared the treatment with a no-treatment control group, when the outcomes are objective and the outcome assessor has been blinded.

In light of our findings, the scope and topics for the Placebo Methods Group have been rewritten. The main changes were to the sections that mentioned the importance of collecting examples of well-designed trials in which the placebo intervention was very effective, the need to rehabilitate the public concept of placebo as a negative contrast in randomised trials, and the notion that the powers of unspecific treatments have been under recognised and under used.

Reference

1. Beecher H. The powerful placebo. Journal of the American Medical Association 1955; 159:1602-1606.

The Prospective Meta-analysis Methods Group’s Internet site has been up and running since early 2000. It has generated a number of queries from individuals who are either interested in the methodology, or are in the process of designing a prospective meta-analysis and are seeking advice. Details of new prospective meta-analyses will be included once they have been through the process outlined in the Group's module on The Cochrane Library (www.cochrane.de/cc/cochrane/pma.htm).

If there is sufficient demand, the Group will run a workshop on prospective meta-analysis during the Cochrane Colloquium at Cape Town. The workshop will aim to give practical guidance to anyone planning a prospective meta-analysis. Areas to be covered include: developing a protocol, establishing a management committee, central co-ordination of data collection and developing a publication policy. The workshop will be of most benefit to those with a specific prospective meta-analyses in mind, but anyone who is interested would be welcome to attend. The number of participants will, however, be limited to create an environment suitable for open discussion.

The convenors of this Methods Group are also working on expanding the section of the Cochrane Reviewers’ Handbook pertaining to prospective meta-analysis, and preparing a corresponding manuscript, which will hopefully be published by the end of 2000. Anyone interested in attending a meeting of the Prospective Meta-Analysis Methods Group during the Cochrane Colloquium at Cape Town in October 2000 should contact

Davina Ghersi (davina@ctc.usyd.edu.au) or Jesse Berlin (jberlin@cceb.upenn.edu).

During the Cochrane Colloquium at Rome, three meetings were organised: a basic training workshop, an advanced training workshop and a closed meeting to discuss internal topics. The Dutch/Belgian MEDION group, the Centre for Reviews and Dissemination in York (UK), and the International Federation of Clinical Chemistry (IFCC) have each been building a database of diagnostic reviews. The MEDION database contains about 250 reviews as well as a series of methodological papers, and the York database has about 50 diagnostic reviews considered to be of sufficient methodological quality to be included in The Database of Abstracts of Reviews of Effectiveness (DARE) database. The IFCC had identified about 40 diagnostic reviews in clinical chemistry. Attempts have been made to merge these databases and to update them regularly. A joint grant application had been submitted to the European Community but was rejected.

As of May 2000, the Statistical Methods Group (SMG) email list has 80 participants. In order to improve the organisation and productivity of the Group, we have created subgroups who are interested in particular methodological topics. These are to be known as topic action groups (TAGs). Each TAG will be responsible for identifying on-going research projects, listing important research questions and publications, contributing to research in the field and advising Cochrane Review Groups.

Nine TAGs have been set up, interested in the following topics: (1) trial quality and reporting, (2) meta-analysis of continuous data, (3) meta-analysis of survival data, (4) meta-analysis of sparse data, (5) meta-analysis of cross-over trials, (6) meta-analysis of cluster randomised trials, (7) Bayesian methods of meta-analysis, (8) computing study weights in meta-analysis, and (9) heterogeneity, subgroups and meta-regression. The last of these has generated the most interest.

It is likely that the number of TAGs will increase over time. Members of the SMG have varied interests and most will belong to more than one TAG. By being more focused and smaller than the full Statistical Methods Group, it is hoped that the topic groups will make greater progress than has been seen so far.

The SMG can identify areas needing methodological research, but it has always been up to individual members to determine what research they will do, especially when projects require external funding. For this reason, we have not in the past had a complete knowledge of what research was being done. We hope that the creation of the TAGs will give us a better idea of what research is ongoing among members of the SMG.

A few years ago the SMG merged with the Standards of Reporting Trials Methods Group. Reporting remains an area of interest to several members of the SMG, and indeed it is one where members of the Group have had considerable success. Notable publications are the CONSORT, QUOROM, and MOOSE statements. The CONSORT statement is a set of recommendations for the reporting of randomised trials.¹ This has been widely supported by medical journals, and now has its own Internet site (www.consort-statement.org). The statement is primarily related to two group parallel trials. It is currently being updated and extended to other trial designs, and we hope that the revised version will be published in 2000. The QUOROM statement² relates to reporting of systematic reviews of randomised trials, whereas MOOSE³ focuses on systematic reviews of observational studies (see pages 15-16). One very valuable feature of the groups that have produced these recommendations is the inclusion of medical journal editors as well as researchers. Both CONSORT and QUOROM have been co-ordinated by David Moher, one of the convenors of the SMG. All three groups have included several SMG members.

Members of the SMG are also heavily involved in 2000 with a complete rewrite of chapter 8 of the Cochrane Reviewers’ Handbook, ‘Analysing and presenting results’.

References

1. Begg CB, Cho MK, Eastwood S, Horton R, Moher D, Olkin I, Rennie D, Schulz KF, Simel DL, Stroup DF. Improving the quality of reporting of randomized controlled trials: the CONSORT statement. JAMA 1996; 276:637-639.

2. Moher D, Cook DJ, Eastwood S, Olkin I, Rennie D, Stroup DF, for the QUOROM group. Improving the quality of reports of meta-analyses of randomized controlled trials: the QUOROM statement. Lancet 1999; 354:1896-1900.

3. Stroup DF, Berlin JA, Morton SC, Olkin I, Williamson GD, Rennie D, Moher D, Becker BJ, Sipe TA, Thacker SB for the MOOSE group. Meta-analysis of observational studies in epidemiology: a proposal for reporting. JAMA. 2000; 283:2008-2012.

The Possible Drug Safety Methods Group comprises scientists from academia, industry and regulatory agencies from Europe, the USA and Australia. There have been informal meetings of the Group, the latest being at the International Conference on PharmacoEpidemiology at Boston in August 1999. Theoretical proposals have been made, differentiating for example tolerability from safety, but no clear guidelines have emerged from these discussions.

At the 1999 meeting, it was proposed that members of the Group should try to address the safety/tolerability issues within existing Cochrane entities and to apply the methods recommended for Cochrane reviews to these safety issues. This would be a first step in identifying methodological difficulties that will arise in retrieving valid safety/tolerability data from published studies. This would be in keeping with requests for help received from Cochrane Review Groups. We are still awaiting results. These actions will be discussed at another meeting, which will take place during the next PharmacoEpidemiology meeting at Barcelona in August 2000.

For some Methods Groups no doubt this past year has been a hectic and productive year. The Qualitative Methods Group has had a more mixed experience. On the positive side, with some prompting from us, there was a session on qualitative research and systematic reviews at the Cochrane Colloquium in Rome. This was really well attended and there was lively debate about the issues raised by the speakers. On the slow side, we started the year with high hopes of applying for registration during the year, but we have not managed this yet – although we have made progress!! We produced a draft module on the proposed work of the group for discussion at a workshop in Rome. This has been revised following comments from group members and is currently on our Internet site www.salford.ac.uk/iphrp/cochrane/homepage.htm .

It has been proposed that a Qualitative Methods Group might be an early joint group between the Cochrane and Campbell Collaboration. Following the launch of the Campbell Collaboration in the USA in February 2000, Jennie Popay is co-ordinating work to establish a Campbell Methods Group, which will focus on the process of intervention and implementation. The scope for combining these groups is still being explored. This has slowed down the process of applying for registration to the Cochrane Collaboration, which has been compounded by work overload for the convenor – something familiar to all those involved in Cochrane Methods Groups. We hope to make much more progress over the coming year.

To end on a high(ish) note, we are identifying more and more people who are involved ‘real time’ in linking qualitative findings to systematic reviews and a list of these people will be put on our Internet site soon. Finally, a group of us have just been short-listed by the UK Health Technology Assessment Commissioning Board to produce a full proposal for methodological and empirical research on the search, appraisal and synthesis of qualitative findings in the context of systematic reviews. If we are successful, we should be able to start some relevant work soon.

The end of 1999 was a quiet period for the possible Quality of Life Methods Group. However, we are now re-launching the process and waking up! In order to re-launch the Quality of Life Methods Group, a meeting was organised on 14 February 2000 with the two convenors of the possible Group and staff from the MAPI Research Institute where it will be based. Several actions were agreed, with the goal of applying for joint registration with the Cochrane and Campbell Collaborations in 2000.

Firstly, the recently registered Non-randomised Studies Methods Group will be contacted for advice and will be used as a model in designing our draft module for The Cochrane Library. The current draft module will be revised (especially our scope and list of topics) to better meet the requirements of the Cochrane Collaboration. Secondly, we will conduct a review of Cochrane reviews in order to demonstrate the need for a Quality of Life Methods Group within the Collaboration. Thirdly, work is underway to categorise the future members of the Quality of Life Methods Group. A questionnaire has been sent to possible members in order to find out more about their interests. This information will help us to co-ordinate the work of the Group, to know who are the best people to answer specific questions, and to organise the methodological activities of the Methods Group. Finally, a survey of Cochrane Review Groups is under way to allow us to develop a research agenda of interest to these groups.

The second meeting of the Possible Reporting Bias Methods Group was held on 8 October 1999 at the Cochrane Colloquium in Rome. The meeting was convened by Matthias Egger (UK) and Jonathan Sterne (UK) and was attended by 21 other interested people. Ongoing research projects, the inclusion of funnel plots in the Cochrane Review Manager Software (RevMan) and the formal registration of the group were the main topics of discussion.

Guido Schwarzer presented findings of research he had recently undertaken, using a sample of meta-analyses from high impact journals and from the Cochrane Database of Systematic Reviews (CDSR). In terms of a quality assessment, the Cochrane reviews performed better than those in the high impact journals. However, when regression tests for bias were carried out, there was little difference between the two. Chris Bartlett outlined his current project in which the contribution to effect estimates of grey literature, and trials published in languages other than English, would be ascertained. A large sample from journals and from the CDSR was being used. Initial work had suggested that grey literature does not always have a great influence on the effect estimate in internal medicine reviews. However, this might not be so in other topic areas, such as complementary medicine.

Regarding the inclusion of funnel plots in RevMan most people agreed with the proposal discussed at the earlier meeting of the Statistical Methods Group (SMG): funnel plots for odds ratios, risk ratios and risk differences should all be implemented and all effect measures should be plotted against the standard error (rather than against sample size, precision or variance). Matthias Egger stressed that the funnel plot should not be seen as a "test for publication bias" since many mechanisms may lead to funnel plot asymmetry and the choice of effect measure may also influence the shape of a funnel plot. Several people argued that more education on the appropriate use and interpretation of the funnel plot (and other plots) is needed. The group agreed to recommend that RevMan should include a pop-up window with a cautionary message.

Some time was spent on discussing the future of the group. Matthias asked whether the group should be formally registered with the Cochrane Collaboration. Alternatively, it could be part of the SMG and become one of the Topic Action Groups (TAGs), which are in the process of being established within the SMG. The question was left open, but Matthias would consult those people who had not been able to come to the meeting.

Since the meeting in Rome a number of things have happened. Some of the work discussed at the meeting and other relevant work has been published or is in press (a full list is available from Matthias Egger). The warning on the use of funnel plots that was recommended for inclusion in RevMan, has been implemented. Finally, consultation with other members who were not present at the meeting in Rome indicated that the group should be registered as a separate entity, although this would not exclude close collaboration with the SMG. The importance of obtaining some funding before the group was registered was discussed in Rome. The good news is that this has now happened and Chris Bartlett will remain in Bristol for another year and will co-ordinate activities for the group. Out targets for 2000 are to register the group; provide advice and support to other Cochrane entities; encourage empirical research and foster exchange; organise workshops aimed at advancing methodology; provide input to the Cochrane Reviewers’ Handbook; and to organise a meeting at the Cochrane Colloquium at Cape Town in October.

Thirty members of the Training and Support Methods Group met during the Cochrane Colloquium at Rome in October 1999, continuing the annual tradition begun in 1994 of providing a face-to-face forum for sharing and updating information. Training and support continue to be prime tools in achieving the Cochrane Collaboration's goal of preparing and maintaining high quality reviews. The overall goal of the possible Cochrane Training and Support Methods Group continues to be to assist in meeting training and support needs throughout the Cochrane Collaboration, particularly for individuals contributing to Cochrane reviews. Many entities within the Collaboration provide training and support for reviewers, including Cochrane Centres, Review Groups, and many of the Methods Groups; as do "sister" entities such as the Centre for Reviews and Dissemination in York.

Brief summaries of training activities organised by Cochrane Centres in the last year were provided at the meeting in Rome. These included updates on activities in the UK (Phil Alderson), Australasia (David Badger), France (Margaret Haugh), Nordic countries (Ole Olson), Spain (Marta Roque and Jordi Pardo), the USA (Christine Aguilar and Fred Wolf), and Canada (Kathie Clark). Ruth Jepson described the Signposts document. Iain Chalmers provided an update on the newly formed Campbell Collaboration and its SPECTR (Sociological, Psychological, and Criminological Trails Register) database. David Badger had reorganised the links to training and support resources on the Cochrane Internet site (www.cochrane.org/cochrane/training.htm).

A large part of the meeting in Rome was spent identifying and discussing the training and support needs of the Collaboration. These include:

• Short courses on analysis and interpretation.
• More flexible interactive learning materials/distance learning.
• Tailored support.
• Continental European co-ordination.
• Cochrane Library training materials in other languages.
• Mentoring new reviewers.
• Package training material and slides.
• On-line chat rooms for experienced reviewers.
• Training for trainers, co-ordinators, editors and trial search co-ordinators.
• Training for copy editing.
• Training for consumers.
• Speakers bureau.