Table 3.
Adverse events-related data extraction form.
| Title of trial report: Name of lead author: | |||||||
|---|---|---|---|---|---|---|---|
| Paper section | Item no. | CONSORT harms recommendations | Checklist for reporting of adverse events-related data | Rating (Y=1, N=0) | If yes, provide page no. | ||
| Y | N | NA | |||||
| Title and abstract | |||||||
| 1 | If the study collected data on harms and benefits, the title or abstract should so state. | 1. If the study of harms was a primary outcome, did the title mention the word ‘harms’ or related terms/phrases or a specific event of interest, or was the information on harms presented in the abstract (including generic statements, e.g., “no adverse events occurred”)? | □ | □ | □ | ||
| If yes, please indicate where: title or abstract or both. | (_______) | ||||||
| Introduction | |||||||
| 2 | If the trial addresses both harms and benefits, the introduction should so state. | 2. If the trial intended to investigate both harms and benefits, was there a balanced presentation of possible benefits and harms of exercise for cancer patients and survivors in the Introduction section? | □ | □ | □ | ||
| Methods | |||||||
| 3 | List addressed adverse events with definitions for each (with attention, when relevant, to grading, expected vs. unexpected events, reference to standardized and validated definitions, and description of new definitions). | 3a. Did the author(s) define the types of adverse events intending to monitor or the recorded adverse events for the study? | □ | □ | □ | ||
| If yes, please indicate if the used definition and grading criteria was validated (reference to the source document) or non-validated (provision of new definition and description of validation process). | (_______) | ||||||
| 3b. Did the author(s) clarify if the reported adverse events included all the adverse events collected or a selected sample? | □ | □ | □ | ||||
| If a selected sample, was an explanation provided as to how, why, and who selected adverse events for reporting (answer Complete, Partial or None depending on the adequacy of information provided)? | (_______) | ||||||
| 3c. Were the author(s) explicit about separately reporting expected and unexpected adverse events? | □ | □ | □ | ||||
| 4 | Clarify how harms-related information was collected (mode of data collection, timing, attribution methods, intensity of ascertainment, and harms-related monitoring and stopping rules, if pertinent). | 4a. Was the mode of adverse events collection specified (i.e., active vs. passive surveillance of harms)? | □ | □ | □ | ||
| If yes, please indicate whether: active or passive or both . | (_______) | ||||||
| 4b. Was the time frame of monitoring for adverse events reported? | □ | □ | □ | ||||
| 4c. If relatedness of collected adverse events to the exercise intervention/testing or cancer treatments undertaken was assigned, did the author(s) specify the attribution process? | □ | □ | □ | ||||
| 4d. Did the author(s) specify rules to discontinue allocated exercise intervention for harms-related reasons? | □ | □ | □ | ||||
| 5 | Describe plans for presenting and analysing information on harms (including coding, handling of recurrent events, specification of timing issues, handling of continuous measures, and any statistical analyses). | 5. Did the author(s) report plans for presenting and analysing adverse events data? | □ | □ | □ | ||
| Results | |||||||
| 6 | Describe for each arm the participant withdrawals that are due to harms and the experience with the allocated treatment. | 6a. Did the author(s) report the number of participants who withdrew due to adverse events (including death) appropriately? | □ | □ | □ | ||
| 6b. Did the author(s) report the number of participants who discontinued or were not adherent to the allocated exercise intervention due to adverse events appropriately? | □ | □ | □ | ||||
| 6c. If there was reporting of withdrawals or discontinuations due to adverse events, did the author(s) report their timing of occurrence appropriately? | □ | □ | □ | ||||
| 7 | Provide the denominators for analyses on harms. | 7. If there were analyses of adverse events data, did the author(s) specify the denominators (i.e., the total number of participants and total follow-up time included in each analysis)? | □ | □ | □ | ||
| 8 | Present the absolute risk of each adverse event (specifying type, grade, and seriousness per arm), and present appropriate metrics for recurrent events, continuous variables and scale variables, whenever pertinent. | 8a. If there were adverse events, did the author(s) report the incidence or frequency for each type and severity category (if relevant) of adverse event appropriately?Alternatively, if there were no adverse events of a specific type and severity, did the author(s) so state? | □ | □ | □ | ||
| *8b. Did the author(s) report the number of affected participants for each type and severity category (if relevant) of adverse event appropriately? | □ | □ | □ | ||||
| 9 | Describe any subgroup analyses and exploratory analyses for harms. | *9. If analyses of adverse events were performed, did the author(s) report any subgroup or exploratory analysis findings? | □ | □ | □ | ||
| Discussion | |||||||
| 10 | Provide a balanced discussion of benefits and harms with emphasis on study limitations, generalizability, and other sources of information on harms. | 10a. If the author(s) intended to investigate both harms and benefits or reported occurrence of adverse events, was there a balanced discussion on efficacy and harms (including no adverse events occurred) findings of the exercise intervention? | □ | □ | □ | ||
| †10b. If there was intention to investigate harms of an exercise intervention, did the author(s) discuss study limitations specific to adverse events findings (e.g., inconclusive findings, lack of power, lack of generalisability, etc)? | □ | □ | □ | ||||
| 10c. If the author(s) intended to investigate both harms and benefits or reported occurrence of adverse events, was there a discussion of any previous evidence on harms findings of exercise in cancer patients and survivors (including data derived from a pilot study of the exercise intervention)? | □ | □ | □ | ||||
Modified from: Ioannidis JP, Evans SJ, Gotzsche PC, O’Neill RT, Altman DG, Schulz K, Moher D, CONSORT Group. Better reporting of harms in randomized trials: an extension of the CONSORT statement. Ann Intern Med. 2004;141:781-788.
*Item not required for case reports.
†Item not required for studies that did not have concurrent controls, including single-arm trials/case series and case reports.
N, no; Y, yes; NA, not applicable.