The following details were extracted from eligible articles: |
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Section 1: Trial details |
1.1. Title |
1.2. Authors |
1.3. Journal |
1.4. Funding body |
1.5. Year of publication (for HTA series only) |
1.6. Rationale of trial |
Section 2: Trial design |
2.1. Recruitment setting, e.g. primary |
2.2. Type of trial, e.g. parallel |
2.3. Number of trial arms |
2.4. Number of primary outcomes |
2.5. Type of primary outcome, e.g. subjective |
2.6. Unit of randomisation |
2.7. Blinding |
(i) Level of blinding |
(ii)Reasons provided for non-blinding or level of blinding |
Section 3: Sample size |
3.1. What was the estimated sample size? |
3.2. Was the estimated sample size obtained? |
Section 4: Trial stopping |
4.1. Did the trial stop early? If yes, give details of why and how this decision was made |
Section 5: Oversight committee reporting |
5.1. If TSC reported |
(i) Are the TSC members listed at the end of the paper? |
a. Name of committee |
b. Number of members |
c. Number of voting members |
d. Chair indicated |
e. Details regarding the number of members by role and by voting rights if applicable |
(ii) Is the TSC discussed in the main body of the paper? If yes, give details |
5.2. If DMC reported |
(i) Are the DMC members listed at the end of the paper? |
a. Name of committee |
b. Number of members |
c. Number of voting members |
d. Chair indicated |
e. Details regarding the number of members by role and by voting rights if applicable |
(ii) Is the DMC discussed in the main body of the paper? If yes, give details |
5.3. If applicable, has the absence of committees been justified? If yes, give details |