Table 1 Modified version of the COBPeer tool [9]
CONSORT items and subitems | |||||
|---|---|---|---|---|---|
METHODS | |||||
Outcomes Comments: 3: The outcome assessment should be described using an existing scale or individually defined parameters 5: Summary of measure needs to be given and specified for each primary outcome. General measurements for all outcomes are not valid 7: Person who analyzed the outcome should be clearly identified | Item 6a. Completely defined pre-specified primary outcome measures, including how and when they were assessed 1. Was(were) the primary outcome(s) clearly identified (e.g., the primary/main outcome was pain)? * For each primary outcome evaluated, were the following elements reported: 2. The variable of interest (e.g., pain, all-cause mortality) 3. How the outcome was assessed (e.g., VAS, Beck Depression Inventory score, pain scale) 4. The analysis metric (e.g., change from baseline, final value, time to event) 5. The summary measure for each study group (e.g., mean, proportion with score > 2) 6. Time point of interest for analysis (e.g., 3 months) NAa if survival analysis 7. Who assessed the outcome (e.g., the patient, doctor, nurse, caregiver, other) | ||||
Randomization/sequence generation | Item 8a. Method used to generate the random allocation sequence Did the authors report the method of sequence generation (e.g., a random number table or computerized random number generator, or other) | ||||
Allocation concealment mechanism | Item 9. Mechanism used to implement the random allocation sequence (e.g., sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | ||||
Blinding | Item 11. Was the study blinded yes/no/not reported? -If yes go to 11a -If no or not reported, go to 13a Item 11a. If done, who was blinded after assignment to interventions (e.g. participants, care providers, those assessing outcomes) and how blinding was performed (e.g. used of placebo) Item 11b. If relevant, description of the similarity of interventions (e.g., appearance, taste, smell, method of administration) | ||||
RESULTS | |||||
Participant flow Comments: 2: The flow-chart or text should clearly state how many participants got analyzed 4: Only “no”, if there are clear signs that participants did not receive the allocated treatment 5: flowchart/text should indicate that no participant stopped/discontinued the treatment 6: if there is no indication for loss to follow-up, answer, “sufficient”, if clearly reported answer “yes” | Did the authors report a flow chart? Item 13a. For each group, were the following subitems reported 1. Number of participants randomized in each group 2. Number of participants who received the intended treatment in each group 3. Number of participants analyzed for the primary outcome in each group Item 13b. For each group, losses and exclusions after randomization, together with reasons 1. Number of participants who did not receive the allocated treatment with reasons in each group 2. Number of participants who discontinued intervention with reasons in each group 3. Number of participants lost to follow-up with reasons in each group 4. Number excluded from analysis with reasons in each group | ||||
Outcomes and estimation | Item 17a. For each primary outcome, results for each group, and the estimated effect size and its precision 1. Result in each group (mean (SD) or number of events/N) 2. Difference in estimated effect between groups (e.g., odds ratio (OR), risk ratio (RR), risk difference (RD), hazard ratio (HR), difference in median survival time, mean difference (MD)) 3. Precision for difference between groups (e.g., 95% CI) | ||||
Harms Comments: If primary outcome(s) is the evaluation of harms, then here we will focus on the rest of harms or the globality of harms 5. If there is no obvious dropout in the analysis, we expect no withdrawals due to harms | Item 19. All-important harms or unintended effects in each group and how they were reported 1. List of adverse events with definition? (classification/grading, expected or not…) 2. Mode of data collection (Full description of methods used to collect the harm related information, who collected the information) 3. Timing (description of time frame of surveillance) 4. Attribution methods (i.e. “related” or not to treatment. Is the person responsible making attribution disclosed and whether blinding was used) 5. For each group, participant withdrawals due to harms 6. Results in each group for each type of harms with denominator (mean [SD] or number of events/N) | ||||
OTHER | |||||
Trial registration | Item 23. Registration number and name of registry | ||||
Consistency between data registered and reported in articles Did authors report the same primary outcome in the registry and article (same variable, same metric, same time point) or was the primary outcome added, deleted, changed | |||||
1. Was the primary outcome(s) reported in the registry or manuscript sufficiently described to identify a switch in outcome(s)? * | Yes | No | |||
2. If yes, did you identify a switch in primary outcome(s)? Stop here if you have answered no to question 1 | Yes | No | |||
3. Did you identify any outcome(s) reported by the authors as a primary outcome(s) but not registered as such? | Yes | No | |||
4. Did you identify any outcome(s) registered as a primary outcome(s) but not reported as such in the manuscript? | Yes | No | |||
5. Did you identify any change in terms of time frame, metric or definition between the primary outcome(s) registered and reported in the article? * | Yes | No | |||
6. If yes, please list the discrepancies: | |||||
- | |||||
7. Did the authors justify the switched outcome(s) in the manuscript? | Yes | No | NA | ||