Certainty assessment | No. of patients | Effect | Certainty | Importance | ||||||||
No. of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | Biceps tenodesis | Biceps tenotomy | Relative (95% CI) | Absolute (95% CI) | ||
Functional PROMs | ||||||||||||
10 | Randomised trials | Serious | Serious† | Not serious | Serious‡ | none | 416 | 403 | – | SMD 0.14 SD higher (0.04 lower to 0.32 higher) | ⨁◯◯◯ Very low | Critical |
Pain (VAS) | ||||||||||||
8 | Randomised trials | Serious§ | Not serious | Not serious | Not serious | None | 350 | 345 | – | MD 0.11 lower (0.28 lower to 0.06 higher) | ⨁⨁⨁◯ Moderate | Important |
Popeye deformity | ||||||||||||
10 | Randomised trials | Serious¶ | Not serious | Not serious | Serious** | Strong association†† | 41/410 (10.0%) | 109/401 (27.2%) | OR 0.29 (0.19 to 0.45) | 174 fewer per 1000 (from 206 fewer to 128 fewer) | ⨁⨁⨁◯ Moderate | Important |
*One out of 10 studies included were at high risk of bias using the Cochrane ROB V.2.0 tool. Only 2 out of 10 studies included were at low risk of bias using the Cochrane ROB V.2.0 tool.
†Moderate heterogeneity (I2=37%) with variable point estimates and CIs.
‡Small sample sizes with no power calculation and an underpowered sample size in 4 out of 10 studies included.
§One out of 8 studies included were at high risk of bias using the Cochrane ROB V.2.0 tool. Only 2 out of 8 studies included were at low risk of bias using the Cochrane ROB V.2.0 tool.
¶One out of 10 studies included were at high risk of bias using the Cochrane ROB V.2.0 tool. Only 2 out of 10 studies included were at low risk of bias using the Cochrane ROB V.2.0 tool.
**Small sample sizes with no power calculation and an underpowered sample size in 3 out of 10 studies included.
††Effect size Z=5.04 (p<0.00001). A Z-score of >2 used as indication of large effect size.
GRADE, Grading of Recommendations Assessment, Development and Evaluation; MD, mean difference; PROMs, patient-reported functional outcome measures ; ROB, Risk of Bias; SMD, standardised mean difference; VAS, Visual Analogue Scale.