Table 3.
The reporting number and percentage for each item of CONSORT 2010 checklist with the non-pharmacological trials extension
| Section/topic | Descriptor summary (Additional items from the non-pharmacological trials extension) | 28 RCTs included in CONSORT endorsing journal | |
|---|---|---|---|
| Number of RCTs | Percent (%) | ||
| Title and abstract | |||
| 1.a) Identification as a randomized trial in the title | 3 | 10.71 | |
| 1.b) Structured summary of trial design, methods, results, and conclusions; for specific guidance (In the abstract, description of the experimental treatment, comparator, care providers, centers and blinding status.) | 2 | 7.14 | |
| Total section (average) | 2.5 | 8.93 | |
| Introduction | |||
| Background and objectives | 2.a) Scientific background and explanation of rationale | 28 | 100 |
| 2.b) Specific objectives or hypotheses | 28 | 100 | |
| Total section (average) | 28 | 100 | |
| Methods | |||
| Trial design | 3.a) Description of trial design (for example, parallel, factorial) including allocation ratio | 4 | 13.79 |
| 3.b) Important changes to methods after trial commencement with reasons | 0 | 0.00 | |
| Participants | 4.a) Eligibility criteria for participants (When applicable, eligibility criteria for centers and those performing the interventions.) | 23 | 79.31 |
| 4.b) Settings and locations where the data were collected | 23 | 79.31 | |
| Interventions | 5) Precise details of both the experimental treatment and comparator | - | - |
| Outcomes | 6.a) Completely defined pre-specified primary and secondary outcome measures, including how and when they were assessed | 17 | 58.62 |
| 6.b) Any changes to trial outcomes after the trial commenced with reasons | 1 | 3.45 | |
| Sample size | 7.a) How sample size was determined (When applicable, details of whether and how the clustering by care providers or centers was addressed.) | 0 | 0.00 |
| 7.b) When applicable, explanation of any interim analyses and stopping guidelines | 0 | 0.00 | |
| Total section (average) | 8.5 | 29.31 | |
| Randomization | |||
| Sequence generation | 8.a) Method used to generate the random allocation sequence (When applicable, how care providers were allocated to each trial group.) | 8 | 28.57 |
| 8.b) Type of randomization; details of any restriction (for example, blocking and block size.) | 3 | 10.71 | |
| Allocation concealment | 9) Mechanism used to implement the random allocation sequence (for example, sequentially numbered containers), describing any steps taken to conceal the sequence until interventions were assigned | 1 | 3.57 |
| Implementation | 10) Who generated the random allocation sequence, who enrolled participants, and who assigned participants to interventions | 5 | 17.86 |
| Blinding | 11.a) If done, who was blinded after assignment to interventions (for example, participants, care providers, those assessing outcomes) and how (Whether or not those administering co-interventions were blinded to group assignment. If blinded, method of blinding and description of the similarity of interventions.) | 4 | 14.29 |
| 11.b) If relevant, description of the similarity of interventions | 1 | 3.57 | |
| Statistical methods | 12.a) Statistical methods used to compare groups for primary and secondary outcomes (When applicable, details of whether and how the clustering by care providers or centers was addressed.) | 0 | 0.00 |
| 12.b) Methods for additional analyses, such as subgroup analyses and adjusted analyses | 0 | 0.00 | |
| Total section (average) | 2.75 | 9.82 | |
| Results | |||
| Participant flow (A diagram is strongly recommended) | 13.a) For each group, the numbers of participants who were randomly assigned, received intended treatment, and were analyzed for the primary outcome (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.) | 23 | 82.14 |
| 13.b) For each group, losses and exclusions after randomization, together with reasons | 5 | 17.86 | |
| Implementation of intervention | Details of the experimental treatment and comparator as they were implemented | 25 | 89.29 |
| Recruitment | 14.a) Dates defining the periods of recruitment and follow-up | 22 | 78.57 |
| 14.b) Why the trial ended or was stopped | 1 | 3.57 | |
| Baseline data | 15) A table showing baseline demographic and clinical characteristics for each group (When applicable, descriptions of care providers (case volume, qualification, expertise, and so on) and centers (volume) in each group.) | 10 | 35.71 |
| Numbers analyzed | 16) For each group, number of participants (denominator) included in each analysis and whether the analysis was by original assigned groups | 3 | 10.71 |
| Outcomes and estimation | 17.a) For each primary and secondary outcome, results for each group, and the estimated effect size and its precision (for example, 95% confidence interval) | 27 | 96.43 |
| 17.b) For binary outcomes, presentation of both absolute and relative effect sizes is recommended | 1 | 3.57 | |
| Ancillary analyses | 18) Results of any other analyses performed, including subgroup analyses and adjusted analyses, distinguishing pre-specified from exploratory | 1 | 3.57 |
| Harms | 19) All important harms or unintended effects in each group; for specific guidance see CONSORT for harms | 6 | 21.43 |
| Total section (average) | 11.3 | 40.26 | |
| Discussion | |||
| Limitations | 20) Trial limitations, addressing sources of potential bias, imprecision, and, if relevant, multiplicity of analyses | 20 | 71.43 |
| Generalizability | 21) Generalizability (external validity) of the trial findings according to the intervention, comparators, patients and care providers and centers involved in the trial | 2 | 7.14 |
| Interpretation | 22) Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence (In addition, take into account the choice of the comparator, lack of or partial blinding, unequal expertise of care providers or centers in each group.) | 2 | 7.14 |
| Total section (average) | 8 | 28.57 | |
| Other information | |||
| Registration | 23) Registration number and name of trial registry | 2 | 7.14 |
| Protocol | 24) Where the full trial protocol can be accessed, if available | 2 | 7.14 |
| Funding | 25) Sources of funding and other support (for example, supply of drugs); role of funders | 9 | 32.14 |
| Total section (average) | 4.3 | 15.48 | |
| Total | 11.28 | 29.6 | |
CONSORT-NPT: Consolidated Standards of Reporting Trials with the non-pharmacological trials extension.
Values are presented as number of reported RCTs divided by the total number of eligible RCTs.
Intervention on non-pharmacological trials included moxibustion and cupping intervention article besides acupuncture and herbal medicine intervention.