Item | Criteria | Items reported, n (%) | Data collection period (2014–15 versus 2006–07) | ||||
---|---|---|---|---|---|---|---|
2014–15 | 2006–07 | Univariate analysisa | Multivariate analysisb | ||||
n = 153 | n = 159 | Odds ratio (95 % CI) | P | Adjusted odds ratio (95 % CI) | P | ||
Title | Identification of the study as randomized | 103 (67.3) | 80 (50.3) | 2.03 (1.30–3.22) | .002 | 1.57 (0.93–2.65) | .090 |
Author contact | Contact details for the corresponding author including both postal and email addresses | 28 (18.3) | 110 (69.2) | 0.10 (0.06–0.17) | < .001 | 0.06 (0.03–0.12) | < .001 |
Trial design | Description of the trial design (eg, parallel, cluster, non-inferiority, parallel, N-of-1 trial, etc.) | 45 (29.4) | 29 (18.2) | 1.87 (1.10–3.18) | .020 | 1.56 (0.86–2.83) | .142 |
Methods | |||||||
- Participants | Eligibility criteria for participants and the settings where the data were collected | 73 (47.7) | 45 (28.3) | 2.31 (1.45–3.69) | < .001 | 1.92 (1.05–3.51) | .034 |
- Interventions | Interventions intended for each group | 142 (92.8) | 140 (88.1) | 1.75 (0.80–3.82) | .154 | 2.26 (0.99–5.12) | .052 |
- Objective | Specific objective or hypothesis | 126 (82.4) | 115 (72.3) | 1.79 (1.04–3.07) | .035 | 1.31 (0.72–2.39) | .384 |
- Outcome | Clearly defined primary outcome | 70 (45.8) | 74 (46.5) | 0.97 (0.62–1.51) | .889 | 0.69 (0.39–1.22) | .200 |
- Randomization | How participants were allocated to interventions | 19 (12.4) | 0 | Not estimable | < .001 | Not estimable | < .001 |
- Blinding (masking) | Whether or not participants, care givers and those assessing the outcomes were blinded to group assignment | 18 (11.8) | 3 (1.9) | 6.93 (2.00–24.05) | < .001 | 4.10 (0.81–20.46) | .087 |
Results | |||||||
- Number randomized | Number of participants randomized to each group | 64 (41.8) | 56 (35.2) | 1.32 (0.84–2.09) | .230 | 1.15 (0.69–1.91) | .601 |
- Recruitment | Trial status | 50 (32.7) | 31 (19.5) | 2.00 (1.19–3.36) | .008 | 1.48 (0.82–2.68) | .192 |
- Number analyzed | Number of participants analyzed in each group | 65 (42.5) | 40 (25.2) | 2.20 (1.36–3.55) | .001 | 1.69 (0.94–3.04) | .077 |
- Outcome | For the primary outcome, a result for each group and the estimated effect size and its precision | 65 (42.5) | 40 (25.2) | 2.20 (1.36–3.55) | .001 | 2.26 (1.17–4.35) | .015 |
- Harms | Important adverse events or side-effects | 78 (51.0) | 75 (47.2) | 1.16 (0.75–1.82) | .501 | 1.15 (0.65–2.02) | .632 |
Conclusions | General interpretation of the results | 118 (77.1) | 102 (64.2) | 1.88 (1.15–3.10) | .012 | 1.59 (0.92–2.74) | .094 |
Trial registration | Registration number and name of trial register | 84 (54.9) | 38 (23.9) | 3.88 (2.39–6.29) | < .001 | 8.32 (3.66–10.88) | < .001 |
Funding | Source of funding | 34 (22.2) | 1 (0.6) | 45.14 (6.09–334.48) | < .001 | Not estimable | < .001 |