| 1. Did the research questions and inclusion criteria for the review include the components of PICO? | ||
| For Yes: | Optional (recommended) | |
| ▯ Population | ▯ Timeframe for follow‐up | ▯ Yes |
| ▯ Intervention | ||
| ▯ Comparator group | ▯ No | |
| ▯ Outcome | ||
| 2. Did the report of the review contain an explicit statement that the review methods were established prior to the conduct of the review and did the report justify any significant deviations from the protocol? * | ||
| For Partial Yes: | For Yes: | ▯ Yes |
| The authors state that they had a written protocol or guide that included ALL the following: | As for partial yes, plus the protocol should be registered and should also have specified: | |
| ▯ review question(s) | ▯ a meta‐analysis/synthesis plan, if appropriate, and | ▯ Partial Yes |
| ▯ a search strategy | ▯ a plan for investigating causes of heterogeneity | ▯ No |
| ▯ inclusion/exclusion criteria | ▯ justification for any deviations from the protocol | |
| ▯ a risk of bias assessment | ||
| 3. Did the review authors explain their selection of the study designs for inclusion in the review? | ||
| For Yes, the review should satisfy ONE of the following: | ||
| ▯ Explanation for including only RCTs | ▯ Yes | |
| ▯ OR Explanation for including only NRSI | ▯ No | |
| ▯ OR Explanation for including both RCTs and NRSI | ||
| 4. Did the review authors use a comprehensive literature search strategy? * | ||
| For Partial Yes (all the following): | For Yes, should also have (all the following): | |
| searched the reference lists/bibliographies of included studies | ▯ Yes | |
| ▯ searched at least 2 databases (relevant to research question) | ▯ searched trial/study registries | ▯ Partial Yes |
| ▯ included/consulted content experts in the field | ▯ No | |
| ▯ provided key word and/or search strategy | ▯ where relevant, searched for grey literature | |
| ▯ justified publication restrictions (e.g. language) | ▯ conducted search within 24 months of completion of the review | |
| 5. Did the review authors perform study selection in duplicate? | ||
| For Yes, either ONE of the following: | ▯ Yes | |
| ▯ at least two reviewers independently agreed on selection of eligible studies and achieved consensus on which studies to include | ▯ No | |
| ▯ OR two reviewers selected a sample of eligible studies and achieved good agreement (at least 80 percent), with the remainder selected by one reviewer. | ||
| 6. Did the review authors perform data extraction in duplicate? | ||
| For Yes, either ONE of the following: | ||
| ▯ at least two reviewers achieved consensus on which data to extract from included studies | ▯ Yes | |
| ▯ OR two reviewers extracted data from a sample of eligible studies and achieved good agreement (at least 80 percent), with the remainder extracted by one reviewer. | ▯ No | |
| 7. Did the review authors provide a list of excluded studies and justify the exclusions? * | ||
| For Partial Yes: | For Yes, must also have: | ▯ Yes |
| ▯ provided a list of all potentially relevant studies that were read in full‐text form but excluded from the review | ▯ Justified the exclusion from the review of each potentially relevant study | ▯ Partial Yes |
| ▯ No | ||
| 8. Did the review authors describe the included studies in adequate detail? | ||
| For Partial Yes (ALL the following): | For Yes, should also have ALL the following: | ▯ Yes |
| ▯ Partial Yes | ||
| ▯ described populations | ▯ described population in detail | ▯ No |
| ▯ described interventions | ▯ described intervention in detail (including doses where relevant) | |
| ▯ described comparators | ▯ described comparator in detail (including doses where relevant) | ▯ Not applicable (no study included) # |
| ▯ described outcomes | ▯ described study's setting | |
| ▯ described research designs | ▯ timeframe for follow‐up | |
| 9. Did the review authors use a satisfactory technique for assessing the risk of bias (RoB) in individual studies that were included in the review? * | ||
| RCTs | ||
| For Partial Yes, must have assessed RoB from | For Yes, must also have assessed RoB from: | ▯ Yes |
| ▯ Partial Yes | ||
| ▯ unconcealed allocation, and | ▯ allocation sequence that was not truly random, and | ▯ No |
| ▯ lack of blinding of patients and assessors when assessing outcomes (unnecessary for objective outcomes such as all‐cause mortality) | ▯ selection of the reported result from among multiple measurements or analyses of a specified outcome | ▯ Includes only NRSI |
| ▯ Not applicable (no study included) # | ||
| NRSI | ||
| For Partial Yes, must have assessed RoB: | For Yes, must also have assessed RoB: | ▯ Yes |
| ▯ from confounding, and | ▯ methods used to ascertain exposures and outcomes, and | ▯ Partial Yes |
| ▯ No | ||
| ▯ from selection bias | ▯ selection of the reported result from among multiple measurements or analyses of a specified outcome | ▯ Includes only RCTs |
| ▯ Not applicable (no study included) # | ||
| 10. Did the review authors report on the sources of funding for the studies included in the review? | ||
| For Yes | ▯ Yes | |
| ▯ Must have reported on the sources of funding for individual studies included in the review. Note: Reporting that the reviewers looked for this information but it was not reported by study authors also qualifies | ▯ No | |
| 11. If meta‐analysis was performed did the review authors use appropriate methods for statistical combination of results? * | ||
| RCTs | ▯ Yes | |
| For Yes: | ▯ No | |
| ▯ The authors justified combining the data in a meta‐analysis | ▯ No meta‐analysis conducted | |
| ▯ AND they used an appropriate weighted technique to combine study results and adjusted for heterogeneity if present. | ||
| ▯ AND investigated the causes of any heterogeneity | ▯ Not applicable (no study included) # | |
| NRSI | ||
| For Yes: | ||
| ▯ The authors justified combining the data in a meta‐analysis | ||
| ▯ AND they used an appropriate weighted technique to combine study results, adjusting for heterogeneity if present | ▯ Yes | |
| ▯ AND they statistically combined effect estimates from NRSI that were adjusted for confounding, rather than combining raw data, or justified combining raw data when adjusted effect estimates were not available | ▯ No | |
| ▯ AND they reported separate summary estimates for RCTs and NRSI separately when both were included in the review | ▯ No meta‐analysis | |
| ▯ Not applicable (no study included) # | ||
| 12. If meta‐analysis was performed, did the review authors assess the potential impact of RoB in individual studies on the results of the meta‐analysis or other evidence synthesis? | ||
| If a systematic review and meta‐analysis planned to do the analysis but ended up not doing because of some technical issue (e.g. no enough included studies), we chose Yes. | ||
| For Yes: | ▯ Yes | |
| ▯ included only low risk of bias RCTs | ▯ No | |
| ▯ OR, if the pooled estimate was based on RCTs and/or NRSI at variable RoB, the authors performed analyses to investigate possible impact of RoB on summary estimates of effect. | ▯ No meta‐analysis | |
| ▯ Not applicable (no study included) # | ||
| 13. Did the review authors account for RoB in individual studies when interpreting/discussing the results of the review? * | ||
| For Yes: | ▯ Yes | |
| ▯ included only low risk of bias RCTs | ▯ No | |
| ▯ OR, if RCTs with moderate or high RoB, or NRSI were included the review provided a discussion of the likely impact of RoB on the results | ▯ Not applicable (no study included) # | |
| 14. Did the review authors provide a satisfactory explanation for, and discussion of, any heterogeneity observed in the results of the review? | ||
| For Yes: | ▯ Yes | |
| ▯ There was no significant heterogeneity in the results | ▯ No | |
| ▯ OR if heterogeneity was present the authors performed an investigation of sources of any heterogeneity in the results and discussed the impact of this on the results of the review | ▯ Not applicable (no study included) # | |
| 15. If they performed quantitative synthesis, did the review authors carry out an adequate investigation of publication bias and discuss its likely impact on the results of the review? * | ||
| For Yes: | ▯ Yes | |
| ▯ No | ||
| ▯ performed graphical or statistical tests for publication bias and discussed the likelihood and magnitude of impact of publication bias | ▯ No meta‐analysis conducted | |
| ▯ Not applicable (no study included) # | ||
| 16. Did the review authors report any potential sources of conflict of interest, including any funding they received for conducting the review? | ||
| For Yes: | ▯ Yes | |
| ▯ The authors reported no competing interests OR | ||
| ▯ The authors described their funding sources and how they managed potential conflicts of interest | ▯ No | |
*
Critical items.
#
We added an option as “Not applicable” for these items when no study was included in a review.