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Table 2 Summary of findings against 9 methodological issues for feasibility research

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

  1. Methodological issues based on Shanyinde et al. (28) and Bugge et al. (29)