Ydo V. Kleinlugtenbelt

Vitamin C to Prevent Complex Regional Pain Syndrome in Patients With Distal Radius Fractures: A Meta-Analysis of Randomized Controlled Trials.

Objective: To determine whether vitamin C is effective in preventing complex regional pain syndrome (CRPS) in patients with distal radius fractures. Data Sources: MEDLINE (1946 to present), EMBASE (1974 to present), and The Cochrane Library (no date limit) were systematically searched up to September 6, 2014, using MeSH and EMTREE headings with free text combinations. Study Selection: Randomized trials comparing vitamin C against placebo were included. No exclusions were made during the selection of eligible trials on the basis of patient age, sex, fracture severity, or fracture treatment. Data Extraction: Two reviewers independently screened articles, extracted data, and applied the Cochrane Risk of Bias tool. Evidence was graded using the Grading of Recommendations Assessment, Development, and Evaluation approach. Data Synthesis: Heterogeneity was quantified using the &khgr;2 test and the I2 statistic. Outcome data were combined with a random effects model. Results: Across 3 trials (n = 890) of patients with distal radius fractures, vitamin C did not reduce the risk for CRPS (risk ratio = 0.45; 95% confidence interval, 0.18–1.13; I2 = 70%). This result was confirmed in sensitivity analyses to test the importance of missing data because of losses to follow-up under varying assumptions. Heterogeneity was explained by diagnostic criteria, but not regimen of vitamin C or fracture treatment. Conclusions: The evidence for vitamin C to prevent CRPS in patients with distal radius fractures fails to demonstrate a significant benefit. The overall quality of the evidence is low, and these results should be interpreted in the context of clinical expertise and patient preferences.

Are validated outcome measures used in distal radial fractures truly valid

Objectives Patient-reported outcome measures (PROMs) are often used to evaluate the outcome of treatment in patients with distal radial fractures. Which PROM to select is often based on assessment of measurement properties, such as validity and reliability. Measurement properties are assessed in clinimetric studies, and results are often reviewed without considering the methodological quality of these studies. Our aim was to systematically review the methodological quality of clinimetric studies that evaluated measurement properties of PROMs used in patients with distal radial fractures, and to make recommendations for the selection of PROMs based on the level of evidence of each individual measurement property. Methods A systematic literature search was performed in PubMed, EMbase, CINAHL and PsycINFO databases to identify relevant clinimetric studies. Two reviewers independently assessed the methodological quality of the studies on measurement properties, using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Level of evidence (strong / moderate / limited / lacking) for each measurement property per PROM was determined by combining the methodological quality and the results of the different clinimetric studies. Results In all, 19 out of 1508 identified unique studies were included, in which 12 PROMs were rated. The Patient-rated wrist evaluation (PRWE) and the Disabilities of Arm, Shoulder and Hand questionnaire (DASH) were evaluated on most measurement properties. The evidence for the PRWE is moderate that its reliability, validity (content and hypothesis testing), and responsiveness are good. The evidence is limited that its internal consistency and cross-cultural validity are good, and its measurement error is acceptable. There is no evidence for its structural and criterion validity. The evidence for the DASH is moderate that its responsiveness is good. The evidence is limited that its reliability and the validity on hypothesis testing are good. There is no evidence for the other measurement properties. Conclusion According to this systematic review, there is, at best, moderate evidence that the responsiveness of the PRWE and DASH are good, as are the reliability and validity of the PRWE. We recommend these PROMs in clinical studies in patients with distal radial fractures; however, more clinimetric studies of higher methodological quality are needed to adequately determine the other measurement properties. Cite this article: Dr Y. V. Kleinlugtenbelt. Are validated outcome measures used in distal radial fractures truly valid?: A critical assessment using the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) checklist. Bone Joint Res 2016;5:153–161. DOI: 10.1302/2046-3758.54.2000462.

Operative versus nonoperative interventions for common fractures of the clavicle: a meta-analysis of randomized controlled trials

BACKGROUND The popularity of surgery for acute displaced midshaft clavicle fractures has been fuelled by early randomized controlled trials (RCTs) showing improved rates of radiographic union and perceived functional benefits compared with nonoperative approaches. We performed a meta-analysis to determine the effect of operative and nonoperative interventions on the risk of secondary operation and complications and on long-term function. METHODS We search MEDLINE, Embase and the Cochrane Central Register of Controlled Trials for reports of relevant RCTs published to Mar. 7, 2014. Two reviewers assessed eligibility of potential reports and the risk of bias of included trials. The Grading of Recommendations Assessment, Development and Evaluation approach was used to summarize the quality of evidence for all outcomes. RESULTS We included 15 RCTs (9 trials comparing operative and nonoperative interventions, 5 comparing implants for operative treatment, and 1 comparing nonoperative treatments). Nonoperative treatments did not differ from operative treatments in the risk of secondary operation (risk ratio [RR] 1.16, 95% confidence interval [CI] 0.58 to 2.35) or all complications (RR 0.90, 95% CI 0.55 to 1.50). One in 4 patients had a complication regardless of the treatment approach. Differences in functional outcomes, although smaller than the threshold for minimal important differences at 1 year, favoured operative interventions (standardized mean difference 0.38, 95% CI 0 to 0.75). Evidence for the type of implant or approach to nonoperative treatment remained inconclusive. INTERPRETATION Current evidence does not support the routine use of internal fixation for the treatment of displaced midshaft clavicle fractures. Complication rates were high regardless of the treatment approach.

Cochrane in CORR ®: Interventions for Treating Proximal Humeral Fractures in Adults (Review)

P roximal humeral fractures are common fractures that account for 6% of all adult fractures [4] with an overall incidence of 19 per 100,000 [8]. Neer estimated that approximately 85% of all proximal humeral fractures were undisplaced, [10] but others have found proportions to be much lower [12]. Proximal humeral fractures are typical osteoporotic fractures, with women about three to four times more often affected than men, and older patients some 16 times more likely to experience this injury than younger patients [8]. They are the third most common fracture in elderly patients after hip and wrist fractures [4]. There is a rise in the incidence of proximal humeral fractures during the last 40 years [8, 11]. The introduction of locking-plate technology in 2002 and reverse shoulder arthroplasty in 2006 for proximal humeral fractures led to a relative increase of surgical treatment of up to 40% [1, 8], but this trend in practice was not supported by high quality evidence. The number of displaced fracture fragments and patient age are the most important factors that influence decision-making and long-term clinical outcomes, but there is considerable variation in current clinical practice. This systematic review and meta-analysis compared surgical versus conservative treatment, different methods of surgical treatment, different methods of conservative treatment (including rehabilitation), and different methods of rehabilitation after surgical treatment for proximal humeral fractures in adults. A Note from the Editor-In-Chief: We are pleased to publish the next installment of Cochrane in CORR, our partnership between CORR, The Cochrane Collaboration, and McMaster University’s Evidence-Based Orthopaedics Group. In it, researchers from McMaster University and other institutions will provide expert perspective on an abstract originally published in The Cochrane Library that we think is especially important. (Handoll HHG, Ollivere BJ, Rollins KE. Interventions for treating proximal humeral fractures in adults. Cochrane Database of Systematic Reviews 2012, Issue 12. Art. No.: CD000434. DOI: 10.1002/ 14651858.CD000434.pub3.) Copyright 2012 The Cochrane Collaboration. Published by John Wiley & Sons, Ltd. Reproduced with permission. Each author certifies that they, or any members of their immediate families, have no funding or commercial associations (eg, consultancies, stock ownership, equity interest, patent/licensing arrangements, etc.) that might pose a conflict of interest in connection with the submitted article. All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research editors and board members are on file with the publication and can be viewed on request. The opinions expressed are those of the writers, and do not reflect the opinion or policy of CORR or The Association of Bone and Joint Surgeons. Cochrane Reviews are regularly updated as new evidence emerges and in response to feedback, and The Cochrane Library (http:// www.thecochranelibrary.com) should be consulted for the most recent version of the review. This Cochrane in CORR column refers to the abstract available at: DOI: 10.1002/ 14651858.CD000434.pub3.

Spectrum bias, a common unrecognised issue in orthopaedic agreement studies: do CT scans really influence the agreement on treatment plans in fractures of the distal radius?

Objectives Current studies on the additional benefit of using computed tomography (CT) in order to evaluate the surgeons’ agreement on treatment plans for fracture are inconsistent. This inconsistency can be explained by a methodological phenomenon called ‘spectrum bias’, defined as the bias inherent when investigators choose a population lacking therapeutic uncertainty for evaluation. The aim of the study is to determine the influence of spectrum bias on the intra-observer agreement of treatment plans for fractures of the distal radius. Methods Four surgeons evaluated 51 patients with displaced fractures of the distal radius at four time points: T1 and T2: conventional radiographs; T3 and T4: radiographs and additional CT scan (radiograph and CT). Choice of treatment plan (operative or non-operative) and therapeutic certainty (five-point scale: very uncertain to very certain) were rated. To determine the influence of spectrum bias, the intra-observer agreement was analysed, using Kappa statistics, for each degree of therapeutic certainty. Results In cases with high therapeutic certainty, intra-observer agreement based on radiograph was almost perfect (0.86 to 0.90), but decreased to moderate based on a radiograph and CT (0.47 to 0.60). In cases with high therapeutic uncertainty, intra-observer agreement was slight at best (-0.12 to 0.19), but increased to moderate based on the radiograph and CT (0.56 to 0.57). Conclusion Spectrum bias influenced the outcome of this agreement study on treatment plans. An additional CT scan improves the intra-observer agreement on treatment plans for a fracture of the distal radius only when there is therapeutic uncertainty. Reporting and analysing intra-observer agreement based on the surgeon’s level of certainty is an appropriate method to minimise spectrum bias. Cite this article: Bone Joint Res 2015;4:190–194.

Classification systems for distal radius fractures: Does the reliability improve using additional computed tomography?

Background and purpose — The reliability of conventional radiography when classifying distal radius fractures (DRF) is fair to moderate. We investigated whether reliability increases when additional computed tomography scans (CT) are used. Patients and methods — In this prospective study, we performed pre- and postreduction posterior–anterior and lateral radiographs of 51 patients presenting with a displaced DRF. The case was included when there was a (questionable) indication for surgical treatment and an additional CT was conducted within 5 days. 4 observers assessed the cases using the Frykman, Fernández, Universal, and AO classification systems. The first 2 assessments were performed using conventional radiography alone; the following 2 assessments were performed with an additional CT. We used the intraclass correlation coefficient (ICC) to evaluate reliability. The CT was used as a reference standard to determine the accuracy. Results — The intraobserver ICC for conventional radiography alone versus radiography and an additional CT was: Frykman 0.57 vs. 0.51; Fernández 0.53 vs. 0.66; Universal 0.57 vs. 0.64; AO 0.59 vs. 0.71. The interobserver ICC was: Frykman: 0.45 vs. 0.28; Fernández: 0.38 vs. 0.44; Universal: 0.32 vs. 0.43; AO: 0.46 vs. 0.40. Interpretation — The intraobserver reliability of the classification systems was fair but improved when an additional CT was used, except for the Frykman classification. The interobserver reliability ranged from poor to fair and did not improve when using an additional CT. Additional CT scanning has implications for the accuracy of scoring the fracture types, especially for simple fracture types.

Are the patient-rated wrist evaluation (PRWE) and the disabilities of the arm, shoulder and hand (DASH) questionnaire used in distal radial fractures truly valid and reliable?

Objectives The patient-rated wrist evaluation (PRWE) and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire are patient-reported outcome measures (PROMs) used for clinical and research purposes. Methodological high-quality clinimetric studies that determine the measurement properties of these PROMs when used in patients with a distal radial fracture are lacking. This study aimed to validate the PRWE and DASH in Dutch patients with a displaced distal radial fracture (DRF). Methods The intraclass correlation coefficient (ICC) was used for test-retest reliability, between PROMs completed twice with a two-week interval at six to eight months after DRF. Internal consistency was determined using Cronbach’s α for the dimensions found in the factor analysis. The measurement error was expressed by the smallest detectable change (SDC). A semi-structured interview was conducted between eight and 12 weeks after DRF to assess the content validity. Results A total of 119 patients (mean age 58 years (sd 15)), 74% female, completed PROMs at a mean time of six months (sd 1) post-fracture. One overall meaningful dimension was found for the PRWE and the DASH. Internal consistency was excellent for both PROMs (Cronbach’s α 0.96 (PRWE) and 0.97 (DASH)). Test-retest reliability was good for the PRWE (ICC 0.87) and excellent for the DASH (ICC 0.91). The SDC was 20 for the PRWE and 14 for the DASH. No floor or ceiling effects were found. The content validity was good for both questionnaires. Conclusion The PRWE and DASH are valid and reliable PROMs in assessing function and disability in Dutch patients with a displaced DRF. However, due to the high SDC, the PRWE and DASH are less useful for individual patients with a distal radial fracture in clinical practice. Cite this article: Y. V. Kleinlugtenbelt, R. G. Krol, M. Bhandari, J. C. Goslings, R. W. Poolman, V. A. B. Scholtes. Are the patient-rated wrist evaluation (PRWE) and the disabilities of the arm, shoulder and hand (DASH) questionnaire used in distal radial fractures truly valid and reliable? Bone Joint Res 2018;7:36–45. DOI: 10.1302/2046-3758.71.BJR-2017-0081.R1.

A Missed Opportunity in Bone Health: Vitamin D and Calcium Use in Elderly Femoral Neck Fracture Patients Following Arthroplasty:

Introduction: Introduction: Adequate calcium and vitamin D from diet and supplementation is recommended for elderly hip fracture patients. Using data from the multinational hip fracture arthroplasty trial (HEALTH), we determined the proportion of patients who consistently took vitamin D and calcium and which characteristics/prescribing practices were associated with consistency of supplement use. Methods: HEALTH is a multicenter randomized trial of elderly hip fracture patients treated with hemi-arthroplasty and total hip arthroplasty. Patients were categorized as consistent users, inconsistent users, or nonusers of calcium and vitamin D. We used multinomial regression to determine the characteristics associated with calcium and vitamin D use. Results: 603 HEALTH participants were included in the analysis. 34.7% of patients never took vitamin D within 12 months after surgery, 26.2% took vitamin D inconsistently, and 39.1% took vitamin D consistently. 36.0% of patients never took calcium within 12 months after surgery, 28.4% took calcium inconsistently, and 35.7% took calcium consistently. There was great variation in prescribed/recommended doses. Compared to nonusers, consistent users of the supplements were more likely to be female, North American, prescribed/recommended vitamin D and/or calcium postoperatively, and presented to a facility with comprehensive fragility fracture protocols. Conclusions: A low proportion of elderly hip fracture patients are consistently taking vitamin D and calcium, which may contribute to poorer bone health. Surgeons should be educated to prescribe/ recommend vitamin D and calcium, institutions should develop comprehensive fragility fracture protocols and patient education strategies to ensure that patients with osteoporosis receive bone health management beyond fracture care.