Reviewers may choose to use the risk of bias table format in the MSAC Therapeutic Guidelines, although it should be noted that not all elements of risk of bias are covered by this format. Alternatives could be the Cochrane risk of bias tool, GRADE approach for assessing the risk of bias, or other tools suitable for RCTs, AMSTAR or PRISMA for systematic reviews, and other validated checklists for non-randomised or observational studies. Whatever the choice, the method of assessing risk of bias should be transparent and justifiable. Please note if an indirect comparison is – presented then the risk of bias assessment of the individual trials/studies would need to be supplemented with an assessment of the exchangeability of the study populations being compared – that is, the results for the common comparator arms should suggest that the populations are similar. For some topics, it may make sense to combine this section with the following section, to reduce duplication. If following Trial methodology, some elements of risk of bias will apply to the study as a whole (e.g. concealment’), while others must be assessed at an outcome level or cluster of outcomes ‘Allocation (e.g. An overall risk of bias should be made for each outcome, across studies. ‘Blinding’). See Appendix C for details on the individual studies included in the evidence base. A summary is provided in Table 11. Keep this section brief, and provide more detail in the study profiles, in Appendix C. Provide any information about the study/participant characteristics that is not reported elsewhere in B.3-B.5, but which is key to interpreting the implications of the evidence. Comment on the applicability (directness) of the included studies. Table 11 Key features of the included evidence comparing intervention with comparator Design/ Risk of Result used in Trial/Study N Patient population Key outcome(s) duration bias economic model R, DB Jones 2010 225 Low Mortality Not used 6 mths R, OL 2012 310 High Response rate Not used 3 mths CS, OL 2005 75 Low QoL Not used 8 mths etc etc <Fixed effect/random effect> model; <overall 410 pooled> <and> Meta-analysis - - - Survival gain k= <subgroup analyses> presented; heterogeneity analysis
Reviewers may choose to use the risk of bias table format in the MSAC Therapeutic Guidelines, although it should be noted that not all elements of risk of bias are covered by this format. Alternatives could be the Cochrane risk of bias tool, GRADE approach for assessing the risk of bias, or other tools suitable for RCTs, AMSTAR or PRISMA for systematic reviews, and other validated checklists for non-randomised or observational studies. Whatever the choice, the method of assessing risk of bias should be transparent and justifiable. Please note – if an indirect comparison is presented then the risk of bias assessment of the individual trials/studies would need to be supplemented with an assessment of the exchangeability of the study populations being compared – that is, the results for the common comparator arms should suggest that the populations are similar. For some topics, it may make sense to combine this section with the following section, to reduce duplication. If following methodology, some elements of risk of bias will apply to the study as a whole (e.g. ‘Allocation concealment’), while others must be assessed at an outcome level or cluster of outcomes (e.g. ‘Blinding’). An overall risk of bias should be made for each outcome, across studies. See Appendix C for details on the individual studies included in the evidence base. A summary is provided in Table 11. Keep this section brief, and provide more detail in the study profiles, in Appendix C. Provide any information about the study/participant characteristics that is not reported elsewhere in B.3-B.5, but which is key to interpreting the implications of the evidence. Comment on the applicability (directness) of the included studies. Table 11 Key features of the included evidence comparing intervention with comparator Trial/Study N Design/ duration Risk of bias Patient population Key outcome(s) Result used in economic model Jones 2010 225 R, DB 6 mths Low Mortality Not used 2012 310 R, OL 3 mths High Response rate Not used 2005 75 CS, OL 8 mths Low QoL Not used etc etc Meta-analysis 410 k= - - <Fixed effect/random effect> model; <overall pooled> <and> <subgroup analyses> presented; heterogeneity analysis - Survival gain Trial
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