To assess the effects (benefits and harms) of ECT for depression in adults - and to integrate patient-lived experiences of ECT given for depression into the effectiveness review by novel methodology. (See sub-heading "The Integrative Methodological Approach" ).
We will assess effects of ECT on a short- (immediately post treatment up to six months) and long-term (six months or more post-treatment commencement) basis, with special focus on long-term cognitive (memory) impairment.The review questions are: 1. Effectiveness 1.1 Effectiveness (benefits)
How effective is ECT, on a short- and long-term basis, at relieving the symptoms of depression and at promoting full recovery of cognitive functioning (memory) and social functioning (activities of daily life) compared to other common treatments for depression (e.g. psychotherapy/cognitive behavioral therapy (CBT), antidepressants)?
- Are there specific gender differences* and/or sub-groups of patients, such as voluntary versus involuntary*, treatment-resistant or psychotic forms of depressive illness, who respond better to ECT compared to other treatments?
- Are there differences in the efficacy of various forms of ECT (electrode placement, dose, waveform and frequency)?
- Is the effect of ECT sustainable over time?
- Is there evidence to support the use of continuation/maintenance ECT?
How harmful is ECT, on both a short- and long-term basis, especially with regards to inducing transient or permanent cognitive impairment?
- Are the adverse effects (i.e. neuropsychological impairment) of ECT different for the different forms (e.g. bilateral, unilateral or high-dose, low-dose) of ECT?
- Are there differences in the rates of adverse events secondary to various forms of ECT, e.g. bilateral versus right-unilateral, high-dose v. low-dose?
- What are the direct risks (i.e. harms*) of ECT (e.g. grand mal seizure), which could be experienced at the time of the actual procedure, including during the administration of anaesthetic?
What is the lived experience of ECT and how do patients perceive the effect of ECT as a therapy?The Integrative Methodological Approach
We will conduct a systematic review which integrates qualitative evidence of the individual patient's experience of the intervention (i.e. ECT as a treatment for depressive illness) into the effectiveness review. The approach was developed by the review team specifically for this systematic review question and was informed by Chapter 20 of the Cochrane Handbook of Systematic Reviews of Interventions (Noyes 2008).
We will use qualitative data in parallel syntheses and juxtaposed alongside quantitative data, in order to i) inform and ii) extend the effectiveness review, as defined in Chapter 20 of the Handbook. The integrative four-phase methodological approach that we will undertake in this review is described in further detail in Appendix 1 and illustrated in Figure 1.
We will treat qualitative and quantitative evidence as two separate streams during the data extraction process: 1. Effectiveness (benefits and harm) and 2. Patient experiences. However, in phase four in order to aid the interpretation of synthesized quantitative evidence we will juxtapose the qualitative evidence alongside it.
We will mark text added during phase two (refinement of the protocol) with an asterisk (*) in the revised protocol. Results from the qualitative evidence aiming to i) inform the effectiveness review by refining the protocol's research questions and population, intervention, comparison and outcome (PICO) elements are given in Appendix 2.
This is the revised version of the protocol, and we have undertaken the protocol refinement based on the qualitative evidence in two main areas: population (P) and outcome (O).
This is a protocol.