From: The use of a synthetic shoulder patch for large and massive rotator cuff tears – a feasibility study
Methodological issues | Findings | Evidence |
---|---|---|
1. Did the feasibility /pilot study allow a sample size calculation for the main trial? | Achieved, estimates obtained suitable for sample size determination for a trial. Measures of dispersion obtained (median and IQR). Effect size measures (differences in medians between groups obtained) and absolute differences between patch and control groups. | Tables 1 and 2 provide the estimates obtained for different outcomes. |
2. What factors influenced eligibility and what proportion of those approached were eligible? | No evidence of cuff tears and participant refusal. | Following the initial ultrasound and clinical examination which indicated presence of a massive cuff tear, 3 patients were found to be ineligible after MRI (2 patients) or arthroscopy (1 participant) found no evidence of a cuff tear. 1 participant asked to withdraw from the study prior to baseline. |
3. Was recruitment successful? | Recruitment was successful. High recruitment due to cross-referrals from upper limb surgeons in the same unit. | Of the potential 75 participants identified, 72 were recruited. |
4. Did eligible participants consent? | High conversion to consent | 100% conversion rate (Fig.1) all 72 that consented were allocated to a study arm |
5. Was the intervention acceptable to the participants? | Not directly assessed but the high numbers recruited suggest little difficulty. | 68 (94%) out of a possible 72 entered the study after consenting |
6. Were outcome assessments completed? | Completion rate was 100% for all questionnaires at baseline Questionnaire completion rates varied at 6 months. | Oxford score 6 month questionnaire (patch 27/28 and controls 26/29) completed SPADI 6 month questionnaire (patch 28/28 and controls 28/29) completed Constant score 6 month questionnaire (patch 28/29 and controls 26/29) completed. |
7. Were outcomes measured those that were the most appropriate outcomes? | All questionnaires assessed main areas of interest (shoulder pain and function) and also patient quality of life | All participants completed all items at baseline |
8. Was retention to the study good? | Once recruited retention was very good for the patch group but appeared lower in the control group | 1 patch patient with no 6 month data and 10 control patients with no 6 month outcome data |
9. Did all the components of the protocol work together? | The study was a success as most components worked well | Recruitment went smoothly, 68 recruited in total from an initial estimate of 60 required |