eTable 2. GRADE evidence profile.
| Certainty of evidence | Summary of findings | ||||||||||
| Number of patients (studies). follow-up | Risk of bias | Inconsistency | Indirectness | Imprecision | Other aspects | Certainty of evidence | Number of patients | RR (95% CI) | Baseline (control group) | MD (surgically treated) |
|
| Control | Surgery | ||||||||||
| a: Randomized controlled trials. Study setting: Adults with full-thickness rotator cuff tears from Finland. Norway. Netherlands | |||||||||||
| Shoulder function (Constant score. 0–100 points. 100 points = best result) | |||||||||||
| 257 (3). 1 year |
Not serious | Not serious | Not serious | Serious*1 | None | MODERATE | 131 | 126 | - | 38.4–57.1 | 6.7 higher*2 (2.3 to 11.0 higher) |
| 210 (2). 2 years |
Not serious | Not serious | Not serious | Serious*1 | None | MODERATE | 105 | 105 | - | 38.4–57.1 | 4.4 higher*2 (0.1 to 8.8 higher) |
| 101 (1). 5 years |
Not serious | Not serious | Not serious | Serious*1 | None | MODERATE | 50 | 51 | - | 38,4 | 8.7 higher*2 (1.3 to 16.1 higher) |
| 91 (1). 10 years |
Not serious | Not serious | Not serious | Serious*1 | None | MODERATE | 48 | 43 | - | 38,4 | 11.8 higher*2 (5.2 to 18.4 higher) |
| Shoulder pain (VAS. 0–10 cm. 0 is best result) | |||||||||||
| 257 (3). 1 year |
Serious*3 | Not serious | Not serious | Serious*1 | None | LOW | 131 | 126 | - | 2.7–6.3 | 1.1 lower*2 (0.5 to 1.7 lower) |
| 210 (2). 2 years |
Serious*3 | Not serious | Not serious | Serious*1 | None | LOW | 105 | 105 | - | 2.7–5.3 | 0.9 lower*2 (0.3 to 1.5 lower) |
| 101 (1). 5 years |
Serious*3 | Not serious | Not serious | Serious*1 | None | LOW | 50 | 51 | - | 5.3 | 1.3 lower*2 (0.5 to 2.1 lower) |
| 91 (1). 10 years |
Serious*3 | Not serious | Not serious | Serious*1 | None | LOW | 48 | 43 | - | 5,3 | 2.0 lower*2 (1.0 to 3.0 lower) |
| Range of motion (Constant subscore. 0–40 points. 40 is best result) | |||||||||||
| 110 (1). 1 year |
Not serious | Not serious | Not serious | Serious*4 | None | MODERATE | 55 | 55 | - | 29,3 | 0.1 lower (0.5 lower to 0.3 higher) |
| 109 (1). 2 years |
Not serious | Not serious | Not serious | Serious*4 | None | MODERATE | 55 | 54 | - | 29.3 | 0.2 lower (0.5 lower to 0.2 higher) |
| Range of motion (Goniometer. pain-free flexion in degrees) | |||||||||||
| 91 (1). 10 years |
Not serious | Not serious | Not serious | Serious*5 | None | MODERATE | 48 | 43 | - | 81,9 | 15.6 higher*2 (0.8 to 32 higher) |
| Muscle strength (Constant subscore. 0–25 points. 25 is best result) | |||||||||||
| 212 (2). 1 year |
Not serious | Not serious | Not serious | Serious*4 | None | MODERATE | 106 | 106 | - | 8.1–8.4 | 0.4 lower (2.0 lower to 1.3 higher) |
| 210 (2). 2 years |
Not serious | Not serious | Not serious | Serious*4 | None | MODERATE | 105 | 105 | - | 8.1–8.4 | 0.1 higher (1.6 lower to 1.8 higher) |
| 101 (1). 5 years |
Not serious | Not serious | Not serious | Serious*4 | None | MODERATE | 50 | 51 | - | 8,1 | 1.3 higher (1.2 lower to 3.8 higher) |
| Adverse events: longest follow-up | |||||||||||
| 255 (3) | Serious*3 | Not serious | Not serious | Serious*4 | None | LOW | 5/130 (3.8%) | 7/125 (5.6%) | 1.4 [0.5; 4.0] | 38 per 1000 | 17 more per 1000 (20 fewer to 127 more) |
| b: Non-randomized controlled intervention studies. Study setting: Adults with full-thickness rotator cuff tears from Canada. Italy. Korea. Japan. USA | |||||||||||
| Shoulder function (Constant score. 0–100 points. 100 is best result) | |||||||||||
| 38 (1). 1.5 years |
Very serious*6 | Not serious | Not serious | Serious*7 | None | VERY LOW | 18 | 20 | - | 47 | 11.6 higher*2 (8.8 to 14.3 higher) |
| 35 (1). 4.5 years |
Very serious*6 | Not serious | Not serious | Very serious*7 | None | VERY LOW | 18 | 17 | - | Not reported | 7.6 higher*2 (1.2 to 14.0 higher) |
| Shoulder pain (VAS. 0–10 cm. 0 is best result) | |||||||||||
| 229 (1). 1 year |
Very serious*6 | Not serious | Not serious | Serious*4 | None | VERY LOW | 114 | 115 | - | 7,1 | 0.1 lower (0.5 lower to 0.3 higher) |
| 137 (1). 0.8 years |
Very serious*6 | Not serious | Not serious | Very serious*8 | None | VERY LOW | 33 | 104 | - | Not reported | 0.5 lower (1.5 lower to 0.5 higher) |
| Range of motion (JOA subscore. 0–30 points. 30 is best result) | |||||||||||
| 40 (1). 4 years |
Very serious*6 | Not serious | Not serious | Very serious*8 | None | VERY LOW | 14 | 26 | - | 18 | 2.7 higher (1.5 lower to 6.9 higher) |
CI. confidence interval; JOA. Japanese Orthopedic Association; MD. mean difference considering the change between the baseline and follow-up measurement of each treatment arm; RR. risk ratio; VAS. visual analog scale
*1 Insufficient precision (wide confidence interval). downgraded by one level: concerns regarding clinical relevance of results. the smallest clinically relevant difference for the endpoint shoulder pain (measured with the Constant score) is 10.4 points and for pain (measured with the VAS). ≥ 1.4 cm
*2 Effect in favor of surgical treatment
*3 Risk of bias. downgraded by one level: concerns regarding lack of blinding. particularly for subjective endpoints (pain and adverse events)
*4 Insufficient precision (wide confidence interval). downgraded by one level: wide 95% CI consistent with both the possibility of benefit (improving symptoms) and the possibility of harm (worsening symptoms)
*5 Insufficient precision (very wide confidence interval). downgraded by one level
*6 Risk of bias. downgraded by two levels: serious confounding. selection bias. and lack of blinding
*7 Insufficient precision (wide confidence interval). downgraded by two levels: concerns regarding clinical relevance of results and low number of patients
*8 Insufficient precision (wide confidence interval). downgraded by two levels: wide 95% CI consistent with both the possibility of benefit (improving symptoms) and the possibility of harm (worsening symptoms). plus low number of patients (endpoint range of motion) or variable group size (endpoint pain)