Summary Research question – If multiple indications are being assessed, consider changing the heading to it safe for XXXX” , or “Is provide sub-headings for the different populations. Concentrate on comparative safety, as measured by the patient-relevant outcomes specified in the PICO Confirmation, if these data are available. The emphasis should be on whether there are clinically relevant differences in the reported harms, irrespective of whether the results are statistically significant. The type of information needed per pre-specified outcome (from the PICO) is in the table below. The table can be copied for additional pre-specified outcomes. Additional graphical representations might be helpful. The meta-analysis is optional it will depend on the available evidence base as to – whether a meta-analysis can be conducted. If a meta-analysis is conducted, forest plots should be presented. For each important outcome, the GRADE approach specifies that the overall quality of the evidence (the confidence in estimates of effect) should be assessed. One domain, the risk of bias, has already been outlined. However, additional domains to be assessed per outcome include inconsistency, indirectness of the population, intervention, comparator, outcome or setting relative to the proposed use of the intervention in the Australian setting, imprecision and risk of publication bias. The quality of evidence for each important outcome may be determined following the GRADE methodology manually, or produced automatically through recording the quality assessment domains using the Development Tool’. Statements regarding each critical and important ‘Guideline safety outcome could therefore be given a grade. The full evidence profile table (with explanatory footnotes), incorporating all critical and important outcomes, should be included in Appendix D. The process also requires the assumed control risk to be determined, as a measure of the typical burden of the disease in the target population (i.e. the Australian population likely to make use of the proposed item number). If there are studies from a directly relevant population in the evidence base, the baseline control risk could be determined from this study or mean baseline risk from a group of studies. Otherwise, assess the baseline risk from relevant observational studies.
Summary – Research question If multiple indications are being assessed, consider changing the heading to “Is it safe for XXXX” , or provide sub-headings for the different populations. Concentrate on comparative safety, as measured by the patient-relevant outcomes specified in the PICO Confirmation, if these data are available. The emphasis should be on whether there are clinically relevant differences in the reported harms, irrespective of whether the results are statistically significant. The type of information needed per pre-specified outcome (from the PICO) is in the table below. The table can be copied for additional pre-specified outcomes. Additional graphical representations might be helpful. The meta-analysis is optional – it will depend on the available evidence base as to whether a meta-analysis can be conducted. If a meta-analysis is conducted, forest plots should be presented. For each important outcome, the GRADE approach specifies that the overall quality of the evidence (the confidence in estimates of effect) should be assessed. One domain, the risk of bias, has already been outlined. However, additional domains to be assessed per outcome include inconsistency, indirectness of the population, intervention, comparator, outcome or setting relative to the proposed use of the intervention in the Australian setting, imprecision and risk of publication bias. The quality of evidence for each important outcome may be determined following the GRADE methodology manually, or produced automatically through recording the quality assessment domains using the ‘Guideline Development Tool’. Statements regarding each critical and important safety outcome could therefore be given a grade. The full evidence profile table (with explanatory footnotes), incorporating all critical and important outcomes, should be included in Appendix D. The process also requires the assumed control risk to be determined, as a measure of the typical burden of the disease in the target population (i.e. the Australian population likely to make use of the proposed item number). If there are studies from a directly relevant population in the evidence base, the baseline control risk could be determined from this study or mean baseline risk from a group of studies. Otherwise, assess the baseline risk from relevant observational studies.
MSAC%20SBA%20or%20CA%20Assessment%20Report%20Template%20-Therapeutic.docx