Table 4: GRADE summary of findings for operative compared with nonoperative treatment for acute displaced midshaft clavicle fractures.
| Patient or population: Patients with an acute displaced midshaft clavicle fractureIntervention: Operative treatment (plate or intramedullary device)Comparison: Nonoperative treatment (standard sling, figure of 8 dressing, or a collar and cuff)Outcomes: Secondary operations, all other complications, long-term function | |||
|---|---|---|---|
| Outcome | No. of participants (studies) | Anticipated effects, risk with operative treatment (95% CI) | GRADE quality of evidence |
| Secondary operationFollow-up: 12 mo | 685 (8) | Evidence suggested higher incidence of secondary operation in operative group (RR 1.16, 95% CI 0.58 to 2.35), but difference was not statistically significant | Low*‡ |
| All other complicationsFollow-up: 12 mo | 685 (8) | Evidence suggested slightly lower number of complications in the operative group (RR 0.9, 95% CI 0.55 to 1.5), but difference was not statistically significant | Low*‡ |
| Long-term functionFollow-up: (≥ 1 yr) | 611 (8) | Mean long-term shoulder function was 0.38 SDs higher in operative group (0.22 lower to 0.54 higher)† | Very low*§ |
Note: CI = confidence interval, GRADE = Grading of Recommendations Assessment, Development, and Evaluation, MID = minimal important difference, RR = risk ratio, SD = standard deviation.
*Downgraded because of risk of bias (lack of blinding study personnel, unclear reporting of allocation concealment and sequence generation).
†Effect failed to exceed MID (smallest effect that an informed patient would perceive as beneficial enough to justify a change in management).
‡Downgraded because of fragility of few events.
§Downgraded for imprecision and inconsistency.
GRADE Working Group grades of evidence:
High quality: Further research is very unlikely to change our confidence in the estimate of effect.
Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate.
Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate.
Very low quality: We are very uncertain about the estimate.