A more comprehensive evaluation of the briefing notes is needed to assess their impact on the appropriate consideration in systematic reviews

Participants identified the need for further examples of sex/gender analysis in systematic reviews with consideration of other intersecting characteristics, and the need to assess and overcome barriers such as lack of sex/gender analysis in primary research and increased workload of applying a gender lens to systematic reviews. Most reviewers seem to want to learn sex/gender analysis and apply this information to reviews despite the barriers identified. However, the barriers deserve further discussion. These approaches may assist in providing methodological guidance on how best to incorporate concepts, such as sex/gender, that do not readily lend themselves to quantification. In fact, the need for methods and tools to contextualise evidence for diverse populations and settings are increasingly being addressed in systematic review methodology. Second, the extent of sex/gender analysis applied to each systematic review will depend on the review question and what is appropriate and/or feasible for that question. For example, researchers considering the effectiveness of total joint arthroplasty may decide to report outcomes by sex to determine whether TJA has different VE-822 benefit-harm ratios for men and women. These reviewers may also justify this methodological decision in the background of their review by highlighting the rich literature on sex/gender and TJA treatment decisions, wait times or symptoms. Or reviewers may decide to contextualize or discuss their findings in the implications section of their review by highlighting the potential practice implications of their findings for men and women. Additionally, our guidance in the briefing notes encourages systematic review authors to report both what is known and not known about the sex/gender implications of their review question. In this way, gaps in knowledge are highlighted, with potential to influence future research agendas, and issues such as a lack of data availability to answer sex/gender-related research questions are documented rather than omitted. The lack of access to data to conduct sex-disaggregated analysis is a challenge cited not only by participants in this pilot project but also by other systematic reviewers. The briefing notes advise authors to contact primary study authors for additional data and to transparently report on the outcome of these requests. As cited by some of the workshop participants who assessed the briefing notes, these requests for data are not always fruitful and can add additional work. Finally, while, workshop participants agreed that sex/gender analysis would add value to a systematic review, many were concerned about the risk of drawing spurious inferences from subgroup analyses, underscoring the need to use appropriate methodology, in alignment with concerns expressed by other investigators. Furthermore, in a 2014 landmark decision, the FDA, for the first time, recommended different dosages of a drug for men and women due to increased adverse effects for women. Availability of sex-disaggregated data may have alerted prescribers and consumers earlier to there being a greater risk for women or gaps in safety evidence for women. This pilot project has limitations that we aim to address in subsequent research. First, our preliminary evaluation was based on a relatively small number of persons, self-selected to attend a Canadian-based meeting. Which we plan to conduct once their full dissemination is underway. It will be important to determine how and in what ways the briefing notes have made an impact on the uptake of sex/gender analysis in systematic reviews.

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