Optional: What is the predicted direction of bias due to Favors experimental / Favors [Rationale] measurement of outcomes or exposures? comparator / Towards null /Away from null / Unpredictable Bias due to 4.1. Is there concern that changes in exposure status occurred Y / PY / PN / N / NI [Description] departures among participants? from intended If your aim for this is to assess the effect of initiating exposures and adhering to an exposure (as in a per-protocol analysis), answer questions 4.2 and 4.3, otherwise continue to 4.4 if Y or PY to 4.1. 4.2. Did many participants switch to other exposures? Y / PY / PN / N / NI [Description] 4.3. Were the critical co-exposures balanced across exposure Y / PY / PN / N / NI [Description] groups? 4.4. If NY/PN PY to 4.1, or Y/PY to 4.2, or 4.3: Were adjustment NA / Y / PY / PN / N / NI [Description] techniques used that are likely to correct for these issues? Risk of bias judgement Low / Moderate / Serious / [Support for judgement] Critical / NI Optional: What is the predicted direction of bias due to Favors experimental / Favors [Rationale] departures from the intended exposures? comparator / Towards null /Away from null / Unpredictable Bias due to [Description] 5.1 Were there missing outcome data? Y / PY / PN / N / NI missing data 5.2 Were participants excluded due to missing data on exposure Y / PY / PN / N / NI [Description] status? 5.3 Were participants excluded due to missing data on other Y / PY / PN / N / NI [Description] variables needed for the analysis? 5.4 If Y/PY to 5.1, 5.2 or 5.3: Are the proportion of participants NA / Y / PY / PN / N / NI [Description] and reasons for missing data similar across exposures? 5.5 If Y/PY to 5.1, 5.2 or 5.3: Were appropriate statistical methods NA / Y / PY / PN / N / NI [Description] used to account for missing data?
Optional: What is the predicted direction of bias due to measurement of outcomes or exposures? Favors experimental / Favors comparator / Towards null /Away from null / Unpredictable [Rationale] Bias due to departures from intended exposures 4.1. Is there concern that changes in exposure status occurred among participants? If your aim for this is to assess the effect of initiating and adhering to an exposure (as in a per-protocol analysis), answer questions 4.2 and 4.3, otherwise continue to 4.4 if Y or PY to 4.1. Y / PY / PN / N / NI [Description] 4.2. Did many participants switch to other exposures? Y / PY / PN / N / NI [Description] 4.3. Were the critical co-exposures balanced across exposure groups? Y / PY / PN / N / NI [Description] 4.4. If NY/PN PY to 4.1, or Y/PY to 4.2, or 4.3: Were adjustment techniques used that are likely to correct for these issues? NA / Y / PY / PN / N / NI [Description] Risk of bias judgement Low / Moderate / Serious / Critical / NI [Support for judgement] Optional: What is the predicted direction of bias due to departures from the intended exposures? Favors experimental / Favors comparator / Towards null /Away from null / Unpredictable [Rationale] Bias due to missing data 5.1 Were there missing outcome data? Y / PY / PN / N / NI [Description] 5.2 Were participants excluded due to missing data on exposure status? Y / PY / PN / N / NI [Description] 5.3 Were participants excluded due to missing data on other variables needed for the analysis? Y / PY / PN / N / NI [Description] 5.4 If Y/PY to 5.1, 5.2 or 5.3: Are the proportion of participants and reasons for missing data similar across exposures? NA / Y / PY / PN / N / NI [Description] 5.5 If Y/PY to 5.1, 5.2 or 5.3: Were appropriate statistical methods used to account for missing data? NA / Y / PY / PN / N / NI [Description]
Risk_of_bias_preliminary_for_exposures_template_Jul2017.docx