Table 4.
Evaluation of the quality of nonrandomized controlled trials by using the CLEAR-NPT checklist
| Item |
Practice; N (%) |
||
|---|---|---|---|
| Yes | No | Unclear | |
| 1. Was the generation of allocation sequences adequate?a | – | – | – |
| 2. Was the treatment allocation concealed?a | – | – | – |
| 3. Were details of the intervention administered to each group made available?b | 17 (81.0%) | 3 (14.3%) | 1 (4.7%) |
| 4. Were care providers’ experience or skillc in each arm appropriate?d | 7 (33.3%) | 4 (19.1%) | 10 (47.6%) |
| 5. Was participant (ie, patients) adherence assessed quantitatively?e | 6 (28.6%) | 13 (61.9%) | 2 (9.5%) |
| 6. Were participants adequately blinded? | 1 (4.8%) | 19 (90.6%) | 1 (4.8%) |
| 6.1. If participants were not adequately blinded | |||
| 6.1.1. Were all other treatments and care (ie, cointerventions) the same in each randomized group? | 5 (25.0%) | 12 (60.0%) | 3 (15.0%) |
| 6.1.2. Were withdrawals and lost to follow-up the same in each randomized group? | 14 (70.0%) | 6 (30.0%) | |
| 7. Were care providers or persons caring for the participants adequately blinded? | 2 (9.5%) | 18 (85.8%) | 1 (4.8%) |
| 7.1. If care providers were not adequately blinded | |||
| 7.1.1. Were all other treatments and care (ie, cointerventions) the same in each randomized group? | 4 (19.1%) | 10 (52.6%) | 5 (26.3%) |
| 7.1.2. Were withdrawals and lost to follow-up the same in each randomized group? | 0 | 11 (57.9%) | 8 (42.1%) |
| 8. Were outcome assessors adequately blinded to assess the primary outcomes? | 2 (9.5%) | 19 (90.5%) | 0 (0.0%) |
| 8.1. If outcome assessors were not adequately blinded, were specific methods used to avoid ascertainment bias (systematic differences in outcome assessment)?f | 0 | 19 (100%) | 0 (0%) |
| 9. Was the follow-up schedule the same in each group?g | 8 (38.1%) | 7 (33.3%) | 6 (28.6%) |
| 10. Were the main outcomes analyzed according to the intention-to-treat principle? | 3 (14.3%) | 18 (85.7%) | 0 (0.0%) |
Notes:
First and second items were not described in order to RCT design;
The answer should be “yes” for this item if these data were either described in the report or made available for each arm (reference to a preliminary report, online addendum etc);
Care provider experience or skill will be assessed only for therapist-dependent interventions (ie, interventions where the success of the treatment are directly linked to care provider’s technical skill). For other treatments, this item is not relevant and should be removed from the checklist or answered “unclear”;
Appropriate experience or skill should be determined according to published data, preliminary studies, guidelines, run-in period, or a group of experts and should be specified in the protocol for each study arm before the beginning of the survey;
Treatment adherence will be assessed only for treatments necessitating interventions (eg, physiotherapy that supposes several sessions, in contrast to a one-shot treatment such as surgery). For one-shot treatments, this item is not relevant and should be removed from the checklist or answered “unclear”;
The answer should be “yes” for this item, if the main outcome is objective or haed, or if outcomes were assessed by a blinded or at least an independent endpoint review committee, or if outcomes were assessed by an independent outcome assessor trained to perform the measurements in a standardized manner, or if the outcome assessor was blinded to the study purpose and hypothesis;
This item is not relevant for trials in which follow-up is part of the question. For example, this item is not relevant for a trial assessing frequent vs less frequent follow-up for cancer recurrence. In these situations, this item should be removed from the checklist or answered “unclear”.
Abbreviation: RCT, randomized controlled trial.