Posted on 5 March 2020 by Froeks Kamminga (Methods Liaison Officer)
Following the launch of the new Cochrane Handbook for Systematic Reviews of Interventions (version 6), the Methods team have updated all references to the Handbook in the Methodological Expectations of Cochrane Intervention Reviews (MECIR). This means that when using the MECIR Standards, either online or within the guidance panels in RevMan, you are now only one click away from the correct section in the Handbook for further reading.
The release of the new Handbook has also led to some changes to the methodological guidance in MECIR. This has similarly been updated and we’ve listed the changes in the March 2020 version of MECIR compared to the previous version below (full details of all versions and changes can be found via the ‘Versions and changes to MECIR’ page):
• During February and March 2020 edits were made to the PR, R, U and UR Standards in MECIR to update referencing to the new Handbook (version 6). All changes are reflected at the bottom of each page.
• PR14: Define in advance which outcomes are primary outcomes and which are secondary outcomes. -changed to- Define in advance outcomes that are critical to the review, and any additional important outcomes.
• PR27: Assess the risk of bias for each included study. For randomized trials, the Cochrane ' Risk of bias' tool should be used, involving judgements and supports for those judgements across a series of domains of bias, as described in Chapter 8 of the Handbook (version 5 or later). -changed to- Assess the risk of bias in at least one specific result for each included study. For randomized trials, the RoB 2 tool should be used, involving judgements and support for those judgements across a series of domains of bias, as described in Handbook (version 6).
• PR28: If the Risk of Bias 2 tool (see Handbook (version 6) Chapter 8) is to be used, state whether interest will be in the effect of assignment to intervention or the effect of adhering to intervention, and explain how results will be selected to be assessed for risk of bias (i.e. for which outcome domains, outcome measures, time points and analyses). ADDED
• PR35: according to summary risk of bias, or restricted to studies at low risk of bias. -changed to- according to summary risk of bias, restricted to studies at low risk of bias or restricted to low-and-some-concerns of risk of bias.
• R32: Define in advance which outcomes are primary outcomes and which are secondary outcomes. -changed to- Define in advance outcomes that are critical to the review, and any additional important outcomes.
• R45: Assess the risk of bias for each included study. For randomized trials, the Cochrane 'Risk of bias' tool should be used, involving judgements and supports for those judgements across a series of domains of bias, as described in Chapter 8 of the Handbook (version 5 or later). -changed to- Assess the risk of bias in at least one specific result for each included study. For randomized trials, the RoB 2 tool should be used, involving judgements and support for those judgements across a series of domains of bias, as described in Handbook version 6.
• R53: according to summary risk of bias, or restricted to studies at low risk of bias. -changed to- according to summary risk of bias, restricted to studies at low risk of bias or restricted to low-and-some-concerns of risk of bias.
• R55: (Include a ‘Summary of Findings’ table according to recommendations described in Chapter 10 of the Cochrane Handbook (version 5 or later). Specifically: include results for one population group (with few exceptions); indicate the intervention and the comparison intervention; include seven or fewer patient-important outcomes; describe the outcomes (e.g. scale, scores, follow-up); indicate the number of participants and studies for each outcome; present at least one baseline risk for each dichotomous outcome (e.g. study population or median/medium risk) and baseline scores for continuous outcomes (if appropriate); summarize the intervention effect (if appropriate); and include a measure of the certainty of the body of evidence) -changed to- Justify and document all assessments of the certainty of the body of evidence (for example downgrading or upgrading if using GRADE).
• R55: MECIR conduct standard 76 (Use the five GRADE considerations (study limitations, consistency of effect, imprecision, indirectness and publication bias) to assess the certainty of the body of evidence for each outcome, and to draw conclusions about the certainty of evidence within the text of the review.) [PRISMA item 12] - changed to- MECIR conduct standard 74: Use the five GRADE considerations (risk of bias, consistency of effect, imprecision, indirectness and publication bias) to assess the certainty of the body of evidence for each outcome, and to draw conclusions about the certainty of evidence within the text of the review.
• R56: to complete a PRISMA type flow chart -changed to- to be able to complete a flow diagram
• R73: Present a ‘Risk of bias’ table for each included study -changed to- Present at least one ‘Risk of bias’ table for each study that is included in a synthesis
• R73: The ‘Risk of bias’ table in RevMan should be used, this is an extension of the table of ‘Characteristics of included studies’. -changed to- ‘Risk of bias’ presentation tools in RevMan should be used wherever possible.
• R73: Assess the risk of bias for each included study. For randomized trials, the Cochrane 'Risk of bias' tool should be used, involving judgements and supports for those judgements across a series of domains of bias, as described in Chapter 8 of the Handbook (version 5 or later) -changed to- Assess the risk of bias in at least one specific result for each included study. For randomized trials, the RoB 2 tool should be used, involving judgements and support for those judgements across a series of domains of bias, as described in Handbook (version 6).
• R74: Summarize the risk of bias -changed to- Present an overall risk of bias assessment
• R76: the heading hierarchy -changed to- any heading hierarchy
• R76: in RevMan5 ADDED
• R76: This standard will not be required when using the study-centric data structure of RevMan Web. ADDED
• R101: Consider the potential impact of reporting biases -changed to- Consider the potential impact of non-reporting biases
• U9: For randomized trials, they must be assessed using a currently accepted version of the Cochrane ‘Risk of bias’ tool. The separation of performance bias and detection bias in the evaluation of blinding is highly desirable. -changed to- If the previous version used the original risk of bias tool to assess randomised trials, consider whether or not to switch to the Risk of Bias 2 tool (see Handbook (version 6) Chapter 8), including how many randomised trials were assessed in the previous version, how many new studies are expected for inclusion in the update, how well it was implemented in the previous version and whether it is feasible to switch.