Article type
Year
Abstract
Background: Stakeholders in the Cochrane Collaboration are increasingly stressing the need for review authors to include NRS in systematic reviews of health care interventions. NRS can provide evidence about rare or long term unintended outcomes, especially harms, or when interventions are difficult to randomise/trials are scarce. Methods for including NRS are not well established and vary across review groups.
Objectives: To disseminate new guidance based on an invited workshop of key stakeholders in June 2010.
Methods: The workshop was structured around 3 hour sessions, mainly involving discussion in small groups. Sessions focused on four key challenges: study design and bias, confounding and metaanalysis, selective reporting and applicability/directness. Guidance was formulated by session leaders based on transcripts of small group and feedback discussions.
Results: Checklists have been devised, providing frameworks for: a taxonomy of study designs based on study design features; assessing the extent of residual confounding and circumstances when review authors might consider metaanalysing data from NRS; detecting selective reporting, based on the existing framework for detecting selective outcome reporting in trials but extended to selective reporting of analyses; assessing directness in NRS and integrating their findings into summary of findings tables. A new tool is required to assess the risk of bias for some NRS, a research topic recently funded by the Methods Innovation Fund.
Conclusions: The checklists will allow review groups to operationalise the inclusion of NRS in systematic reviews in a more consistent way. The need for a tool to assess the risk of bias in NRS is a priority.
Objectives: To disseminate new guidance based on an invited workshop of key stakeholders in June 2010.
Methods: The workshop was structured around 3 hour sessions, mainly involving discussion in small groups. Sessions focused on four key challenges: study design and bias, confounding and metaanalysis, selective reporting and applicability/directness. Guidance was formulated by session leaders based on transcripts of small group and feedback discussions.
Results: Checklists have been devised, providing frameworks for: a taxonomy of study designs based on study design features; assessing the extent of residual confounding and circumstances when review authors might consider metaanalysing data from NRS; detecting selective reporting, based on the existing framework for detecting selective outcome reporting in trials but extended to selective reporting of analyses; assessing directness in NRS and integrating their findings into summary of findings tables. A new tool is required to assess the risk of bias for some NRS, a research topic recently funded by the Methods Innovation Fund.
Conclusions: The checklists will allow review groups to operationalise the inclusion of NRS in systematic reviews in a more consistent way. The need for a tool to assess the risk of bias in NRS is a priority.