Summary of findings for the main comparison. Surgery compared to non‐operative treatment for people with full thickness rotator cuff tears.
| Surgery compared to non‐operative treatment for people with full thickness rotator cuff tears | ||||||
| Patient or population: people with full‐thickness rotator cuff tears Setting: hospital Intervention: subacromial decompression and rotator cuff repair Comparison: non‐operative treatment (exercises with or without glucocorticoid injection) | ||||||
| Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
| Risk with non‐operative treatment | Risk with surgery | |||||
| Pain (VAS) from 0 to 10, 0 is no pain follow‐up 12 months | The mean pain was 1.61 | MD 0.87 better (0.43 better to 1.30 better) | ‐ | 258 (3 RCTs) | ⊕⊕⊕⊝ Moderate2 | Surgery provides probably little or no benefit; absolute difference 9% better (4% better to 13% better)3; relative difference 16% better (8% better to 25% better)4 |
| Functional outcome (Constant score) from 0 to 100, 100 is best) follow‐up 12 months | The mean function was 72 points1 | MD 5.98 better (2.43 better to 9.54 better) | ‐ | 269 (3 RCTs) | ⊕⊕⊝⊝ Low2,5 | Surgery may have little or no effect; absolute difference 6% better (2% better to 10% better)3; relative difference 16% better (6% better to 25% better)3 |
| Participant‐rated global assessment of treatment success at 12 months | 873 per 1,000 | 943 per 1,000 (838 to 1,000) | RR 1.08 (0.96 to 1.22) | 110 (1 RCT) | ⊕⊕⊝⊝ Low2,5 | Number of participants reporting success may not differ; absolute difference 7% better (4% worse to 13% better); relative difference 8% better (4% worse to 22% better)4 |
| Health‐related quality of life (SF‐36 mental component) from 0‐100; 100 is best) follow‐up 12 months |
The mean health‐related quality of life was 57.5 points1 | MD 1.39 worse (4.49 worse to 1.89 better) | ‐ | 103 (1 RCT) | ⊕⊕⊕⊝ Low2,5 | Surgery may have little or no effect; absolute difference 1% worse (4% worse to 2% better)3; relative difference 2% worse (8% worse to 3% better)3 |
| Adverse events | One frozen shoulder | No events | No reliable estimate | 103 (1 RCT) | ⊕⊝⊝⊝ Very low2,5,6 | We are uncertain about the risks of adverse events |
| Serious adverse events | No events | No events | No reliable estimate | ⊕⊝⊝⊝ Very low2,5,6 | We are uncertain about the risks of serious adverse events | |
| *The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; MD: mean difference; RCT: randomised controlled trial; RR: Risk ratio. | ||||||
| GRADE Working Group grades of evidence High certainty: we are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: we are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: our confidence in the effect estimate is limited, The true effect may be substantially different from the estimate of the effect Very low certainty: we have very little confidence in the effect estimate. The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Median value in the exercise groups at one year.
2 Downgraded one level due to risk of bias, due to potential for performance and detection biases.
3 We assumed the clinically important improvement was 1.5 points or 15% absolute improvement (Hao 2018) for pain; 8.3 points or 8% absolute improvement (Hao 2018) for function; and 10 points or 10% absolute improvement for health‐related quality of life.
4 Relative difference calculated relative to baseline in control group (i.e. absolute change (mean difference) divided by mean at baseline in the non‐operative group from Moosmayer 2010 (values were: 5.3 points on 0 to 10 point VAS pain; 38.4 points on 0 to 100 point Constant score and 57.3 in 0 to 100 point SF‐36 mental component score), and expressed as percentage for continuous outcomes. Relative difference calculated as 1‐RR and expressed as percentage for dichotomous outcomes.
5 Downgraded one level due to imprecision, as 95% CI included both a clinically important effect and a clinically unimportant effect, or had low event rates.
6 Downgraded again due to very serious imprecision (no events were reported and we are unable to estimate the risk)