Operative versus nonoperative treatment of proximal humeral fractures: a systematic review, meta-analysis, and comparison of observational studies and randomized controlled trials

Beks, Reinier B.; Ochen, Yassine; Frima, Herman; Smeeing, Diederik P.J.; Meijden, Olivier van der; Timmers, Tim K.; Velde, Detlef van der; Heijl, Mark van; Leenen, Luke P. H.; Groenwold, Rolf H H; Houwert, Roderick M.

doi:10.1016/j.jse.2018.03.009

Cited by 126 publications

(98 citation statements)

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“…Furthermore, no difference was observed in effect estimates from RCTs and observational studies regarding the primary outcome measures. These results are in line with previous orthopedic trauma meta-analyses, [9][10][11][12] shown an increase of distal radius fractures in patients aged 17 to 64 years. 2 Hence, future studies should also focus on the nonelderly population, because traditionally most studies on this topic solely include patient populations 60 years or older.…”

Section: Jama Network Open | Orthopedicssupporting

confidence: 93%

Operative vs Nonoperative Treatment of Distal Radius Fractures in Adults

et al. 2020

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IMPORTANCENo consensus has been reached to date regarding the optimal treatment for distal radius fractures. The international rate of operative treatment has been increasing, despite higher costs and limited functional outcome evidence to support this shift. OBJECTIVESTo compare functional, clinical, and radiologic outcomes after operative vs nonoperative treatment of distal radius fractures in adults. DATA SOURCES The PubMed/MEDLINE, Embase, CENTRAL (Cochrane Central Register of Controlled Trials), and CINAHL (Cumulative Index to Nursing and Allied Health Literature) databases were searched from inception to June 15, 2019, for studies comparing operative vs nonoperative treatment of distal radius fractures. STUDY SELECTION Randomized clinical trials (RCTs) and observational studies reporting on the following: acute distal radius fracture with operative treatment (internal or external fixation) vs nonoperative treatment (cast immobilization, splinting, or bracing); patients 18 years or older; and functional outcome. Studies in a language other than English or reporting treatment for refracture were excluded. DATA EXTRACTION AND SYNTHESIS Data extraction was performed independently by 2 reviewers. Effect estimates were pooled using random-effects models and presented as risk ratios (RRs) or mean differences (MDs) with 95% CIs. Data were analyzed in September 2019. MAIN OUTCOMES AND MEASURES The primary outcome measures included medium-term functional outcome measured with the Disabilities of the Arm, Shoulder and Hand questionnaire (DASH) and the overall complication rate after operative and nonoperative treatment.RESULTS A total of 23 unique studies were included, consisting of 8 RCTs and 15 observational studies, that described 2254 unique patients. Among the studies that presented sex data, 1769 patients were women [80.6%]. Overall weighted mean age was 67 [range, 22-90] years). The RCTs included 656 patients (29.1%); observational studies, 1598 patients (70.9%). The overall pooled effect estimates the showed a significant improvement in medium-term (Յ1 year) DASH score after operative treatment compared with nonoperative treatment (MD,]; P = .005; I 2 = 84%). No difference in complication rate was observed (RR, 1.03 [95% CI, 0.69-1.55]; P = .87; I 2 = 62%). A significant improvement in grip strength was noted after operative treatment, measured in kilograms (MD, 2.73 [95% CI,]; P = .04; I 2 = 79%) and as a percentage of the unaffected side (MD, 8.21 [95% CI,]; P = .007; I 2 = 76%). No improvement in mediumterm DASH score was found in the subgroup of studies that only included patients 60 years or older (MD, −0.98 [95% CI, −3.52 to 1.57]; P = .45; I 2 = 34%]), compared with a larger improvement in (continued)

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Section: Jama Network Open | Orthopedicssupporting

confidence: 93%

Operative vs Nonoperative Treatment of Distal Radius Fractures in Adults

et al. 2020

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“…For certain type 3 comparisons an observational study design may therefore be suitable. Similar to type 2 comparisons, multiple recent meta-analyses where surgery was compared to conservative treatment indeed found that treatment groups appeared to be similar and effect estimates were comparable between observational studies and randomized trials [7][8][9]. In studies of type 3 comparisons, treatment groups may indeed be comparable if the surgeon's preference for one treatment option over the other is of greater influence on treatment decisions than (unmeasured) patient characteristics.…”

Section: Type 3: Comparison Of Surgical and Non-surgical Interventionmentioning

confidence: 87%

“…Provided observational studies are of high quality, adding information from observational studies to meta-analyses will increase the number of patients available for analysis and can lead to more precise effects estimates, possibilities for subgroup analysis, and may provide more insight in rare and longterm outcomes [7]. Obviously, only high quality observational studies should be included for meta-analysis, or at least sensitivity analysis, stratified by study quality, needs to be conducted [7][8][9]. Alternatively, statistical methodology has been developed to include external (observational) data in the analysis of randomized trials, that accounts for their (dis-)similarity [33,34].…”

Section: Combining Information Of Different Study Designsmentioning

confidence: 99%

“…RCTs in surgery may not always be ethical, feasible, or necessary to address a particular research question. If so, properly designed and conducted observational studies can be valuable alternatives for an RCT and produce credible results [7][8][9][10][11]. In this paper, we elaborate on complementary use of observational studies and RCTs and the need for both.…”

Section: Introductionmentioning

confidence: 99%

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Study methodology in trauma care: towards question-based study designs

Houwert

Beks

Dijkgraaf

et al. 2019

Eur J Trauma Emerg Surg

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The randomized controlled trial (RCT) in surgery may not always be ethical, feasible, or necessary to address a particular research question about the effect of a surgical intervention. If so, properly designed and conducted observational (nonrandomized) studies may be valuable alternatives for an RCT and produce credible results. In this paper, we discus differences between RCTs and observational studies and differentiate between three types of comparisons of surgical interventions. We assert that results of different designs should be regarded as complementary to each other when evaluating surgical interventions. Criteria for credible observational research are presented to provide guidance for future observational research of surgical interventions. We argue that the research question that is being asked should guide the discussion about the value of a particular study design.

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“…Die Therapieoptionen bei einer Humeruskopffraktur gehen von der konservativen Therapie über die rekonstruktive Osteosynthese bis zur primär endoprothetischen Versorgung. Die Basis der adäquaten operativen Frakturversorgung sind: [3]. Des Weiteren besteht eine Operationsindikation bei Luxations-oder Head-Split-Frakturen.…”

Section: Therapieoptionenunclassified