Appendix Checklist of items for reporting trials of nonpharmacologic treatmentsa
From: Comparing Drug and Nondrug Technologies in Comparative Effectiveness Research
Section | Item | Standard CONSORT description | Extension for nonpharmacologic trials | Reported on page no. |
|---|---|---|---|---|
Title and abstract b | 1 | How participants were allocated to interventions (e.g., “random allocation,” “randomized,” or “randomly assigned”) | In the abstract, description of the experimental treatment, comparator, care providers, centers, and blinding status | |
Introduction | ||||
Background | 2 | Scientific background and explanation of rationale | ||
Methods | ||||
Participantsb | 3 | Eligibility criteria for participants and the settings and locations where the data were collected | When applicable, eligibility criteria for centers and those performing the interventions | |
Interventionsb | 4 | Precise details of the interventions intended for each group and how and when they were actually administered | Precise details of both the experimental treatment and comparator | |
4A | Description of the different components of the interventions and, when applicable, descriptions of the procedure for tailoring the interventions to individual participants | |||
4B | Details of how the interventions were standardized | |||
4C | Details of how adherence of care providers with the protocol was assessed or enhanced | |||
Objectives | 5 | Specific objectives and hypotheses | ||
Outcomes | 6 | Clearly defined primary and secondary outcome measures and, when applicable, any methods used to enhance the quality of measurements (e.g., multiple observations, training of assessors) | ||
Sample sizeb | 7 | How sample size was determined and, when applicable, explanation of any interim analyses and stopping rules | When applicable, details of whether and how the clustering by care providers or centers was addressed | |
Randomization-sequence generationb | 8 | Method used to generate the random allocation sequence, including details of any restriction (e.g., blocking, stratification) | When applicable, how care providers were allocated to each trial group | |
Allocation concealment | 9 | Method used to implement the random allocation sequence (e.g., numbered containers or central telephone), clarifying whether the sequence was concealed until interventions were assigned | ||
Implementation | 10 | Who generated the allocation sequence, who enrolled participants, and who assigned participants to their groups | ||
Blinding (masking)b | 11A | Whether or not participants, those administering the interventions, and those assessing the outcomes were blinded to group assignment | Whether or not those administering co-interventions were blinded to group assignment | |
11B | If blinded, method of blinding and description of the similarity of interventionsb | |||
Statistical methodsb | 12 | Statistical methods used to compare groups for primary outcome(s); methods for additional analyses, such as subgroup analyses and adjusted analyses | When applicable, details of whether and how the clustering by care providers or centers was addressed | |
Results | ||||
Participant flowb | 13 | Flow of participants through each stage (a diagram is strongly recommended) – specifically, for each group, report the number of participants randomly assigned, receiving intended treatment, completing the study protocol, and analyzed for the primary outcome; describe deviations from study as planned, together with reasons | The number of care providers or centers performing the intervention in each group and the number of patients treated by each care provider or in each center | |
Implementation of interventionb | New item | Details of the experimental treatment and comparator as they were implemented | ||
Recruitment | 14 | Dates defining the periods of recruitment and follow-up | ||
Baseline datab | 15 | Baseline demographic and clinical characteristics of each group | When applicable, a description of care providers (case volume, qualification, expertise, etc.) and centers (volume) in each group | |
Numbers analyzed | 16 | Number of participants (denominator) in each group included in each analysis and whether analysis was by “intention-to-treat”; state the results in absolute numbers when feasible (e.g., 10/20, not 50 %) | ||
Outcomes and estimation | 17 | For each primary and secondary outcome, a summary of results for each group and the estimated effect size and its precision (e.g., 95 % confidence interval) | ||
Ancillary analyses | 18 | Address multiplicity by reporting any other analyses performed, including subgroup analyses and adjusted analyses, indicating those prespecified and those exploratory | ||
Adverse events | 19 | All important adverse events or side effects in each intervention group | ||
Discussion | ||||
Interpretationb | 20 | Interpretation of the results, taking into account study hypotheses, sources of potential bias or imprecision, and the dangers associated with multiplicity of analyses and outcomes | In addition, take into account the choice of the comparator, lack of or partial blinding, and unequal expertise of care providers or centers in each group | |
Generalizabilityb | 21 | Generalizability (external validity) of the trial findings | Generalizability (external validity) of the trial findings according to the intervention, comparators, patients, and care providers and centers involved in the trial | |
Overall evidence | 22 | General interpretation of the results in the context of current evidence | ||