Helen Handoll

Interventions for treating wrist fractures in children

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: To assess the effects (benefits and harms) of interventions for common distal radius fractures in children, including skeletally immature adolescents.

The Cochrane Collaboration: a leading role in producing reliable evidence to inform healthcare decisions in musculoskeletal trauma and disorders.

Systematic reviews are a key component of evidence-based practice. A valuable and accessible source of good quality systematic reviews on topics in musculoskeletal trauma and disorders is the Cochrane Database of Systematic Reviews, published in The Cochrane Library. These reviews are produced by members of The Cochrane Collaboration, an international not-for-profit organization that aims to make up-to-date, accurate information about the effects of healthcare readily available worldwide. Contributions from orthopedic specialists in India and neighboring countries are required to make the Cochrane Database an even more useful and comprehensive resource of reliable evidence. Linked with this is the opportunity for orthopedic specialists to take a leading role in generating the evidence to inform their practice.

Randomised trials in surgery

Editor—As Cochrane reviewers appraising randomised controlled trials on surgical interventions for orthopaedic trauma and through our involvement with the promotion of evidence based orthopaedic surgery in Teesside, we would like to endorse and extend the observations of McCulloch et al on randomised controlled trials in surgery.1 Although issues specific to surgical trials mentioned by McCulloch et al also apply, most of the trials we have reviewed have methodological defects that could have been avoided. For example, concealment of study allocation is always possible, yet this was confirmed in just two of the 44 trials included in a review of surgical treatment of wrist fractures in adults.2 Tackling any “lack of education in clinical epidemiology,” and various other measures proposed by McCulloch et al will go some way towards addressing the current state of affairs in research in surgery, but more is needed. Surgeons should realise that using the right tools for clinical research is comparable to selecting and using the right instruments for an operation. Proper attention to study design, conduct, analysis, and reporting is equally crucial. Overall we need an integrated programme incorporating research, audit, and training.3 This model proposes that, given the aim of medical practice is to improve patient care by “doing things that matter,” we have the responsibility to do three things: (a) find out what matters (through primary or secondary research); (b) apply the findings (and audit practice); and (c) train clinicians if the right things are not being done the right way, every time. Keeping research, audit, and training separate does little to improve patient care ultimately; it is better to develop integrated programmes starting with the most common conditions in the specialty.

Five-year follow-up results of the PROFHER trial comparing operative and non-operative treatment of adults with a displaced fracture of the proximal humerus

Aims The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non‐operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long‐term treatment effects beyond the two‐year follow‐up. Patients and Methods Of the original 250 trial participants, 176 consented to extended follow‐up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D‐3L (EQ‐5D‐3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied. Results OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non‐operative treatment at each follow‐up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ‐5D‐3L data showed no significant between‐group differences in quality of life over time. Conclusion These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years.

Cost effectiveness of surgical versus non-surgical treatment of adults with displaced fractures of the proximal humerus: economic evaluation alongside the PROFHER trial.

AIMS A pragmatic multicentre randomised controlled trial (PROFHER) was conducted in United Kingdom National Health Service (NHS) hospitals to evaluate the clinical effectiveness and cost effectiveness of surgery compared with non-surgical treatment for displaced fractures of the proximal humerus involving the surgical neck in adults. METHODS A cost utility analysis from the NHS perspective was performed. Differences between surgical and non-surgical treatment groups in costs and quality adjusted life years (QALYs) at two years were used to derive an estimate of the cost effectiveness of surgery using regression methods. RESULTS Patients randomised to receive surgical intervention accumulated mean greater costs and marginally lower QALYs than patients randomised to non-surgery. The surgical intervention cost a mean of £1758 more per patient (95% confidence intervals (CI) £1126 to £2389). Total QALYs for the surgical group were smaller than those for non-surgery -0.0101 (95% CI -0.13 to 0.11). The probability of surgery being cost effective was less than 10% given the current NICE willingness to pay at a threshold of £20 000 for an additional QALY. The results were robust to sensitivity analyses. DISCUSSION The results suggest that current surgical treatment is not cost effective for the majority of displaced fractures of the proximal humerus involving the surgical neck in the United Kingdoms NHS. TAKE HOME MESSAGE The results of this trial do not support the trend of increased surgical treatment for patients with displaced fractures of the proximal humerus involving the surgical neck within the United Kingdom NHS.

Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures

Objectives Accurate characterisation of fractures is essential in fracture management trials. However, this is often hampered by poor inter-observer agreement. This article describes the practicalities of defining the fracture population, based on the Neer classification, within a pragmatic multicentre randomised controlled trial in which surgical treatment was compared with non-surgical treatment in adults with displaced fractures of the proximal humerus involving the surgical neck. Methods The trial manual illustrated the Neer classification of proximal humeral fractures. However, in addition to surgical neck displacement, surgeons assessing patient eligibility reported on whether either or both of the tuberosities were involved. Anonymised electronic versions of baseline radiographs were sought for all 250 trial participants. A protocol, data collection tool and training presentation were developed and tested in a pilot study. These were then used in a formal assessment and classification of the trial fractures by two independent senior orthopaedic shoulder trauma surgeons. Results Two or more baseline radiographic views were obtained for each participant. The independent raters confirmed that all fractures would have been considered for surgery in contemporaneous practice. A full description of the fracture population based on the Neer classification was obtained. The agreement between the categorisation at baseline (tuberosity involvement) and Neer classification as assessed by the two raters was only fair (kappa 0.29). However, this disparity did not appear to affect trial findings, specifically in terms of influencing the effect of treatment on the primary outcome of the trial. Conclusions A key reporting requirement, namely the description of the fracture population, was achieved within the context of a pragmatic multicentre randomised clinical trial. This article provides important guidance for researchers designing similar trials on fracture management. Cite this article: H. H. G. Handoll, S. D. Brealey, L. Jefferson, A. Keding, A. J. Brooksbank, A. J. Johnstone, J. J. Candal-Couto, A. Rangan. Defining the fracture population in a pragmatic multicentre randomised controlled trial: PROFHER and the Neer classification of proximal humeral fractures.Bone Joint Res 2016;5:481–489. DOI: 10.1302/2046-3758.510.BJR-2016-0132.R1.

Prognostic Models in Adults Undergoing Physical Therapy for Rotator Cuff Disorders: Systematic Review

Background Rotator cuff–related disorders represent the largest subgroup of shoulder complaints. Despite the availability of various conservative and surgical treatment options, the precise indications for these options remain unclear. Purpose The purpose of this systematic review was to synthesize the available research on prognostic models for predicting outcomes in adults undergoing physical therapy for painful rotator cuff disorders. Data Sources The MEDLINE, EMBASE, CINAHL, Cochrane CENTRAL, and PEDro databases and the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) up to October 2015 were searched. Study Selection The review included primary studies exploring prognostic models in adults undergoing physical therapy, with or without other conservative measures, for painful rotator cuff disorders. Primary outcomes were pain, disability, and adverse events. Inclusion was limited to prospective investigations of prognostic factors elicited at the baseline assessment. Study selection was independently performed by 2 reviewers. Data Extraction A pilot-tested form was used to extract data on key aspects of study design, characteristics, analyses, and results. Risk of bias and applicability were independently assessed by 2 reviewers using the Prediction Study Risk of Bias Assessment tool (PROBAST). Data Synthesis Five studies were included in the review. These studies were extremely heterogeneous in many aspects of design, conduct, and analysis. The findings were analyzed narratively. Limitations All included studies were rated as at high risk of bias, and none of the resulting prognostic models was found to be usable in clinical practice. Conclusions There are no prognostic models ready to inform clinical practice in the context of the review question, highlighting the need for further research on prognostic models for predicting outcomes in adults who undergo physical therapy for painful rotator cuff disorders. The design and conduct of future studies should be receptive to developing methods.

Developing, delivering and documenting rehabilitation in a multi-centre randomised controlled surgical trial: experiences from the ProFHER trial

Objectives A rigorous approach to developing, delivering and documenting rehabilitation within randomised controlled trials of surgical interventions is required to underpin the generation of reliable and usable evidence. This article describes the key processes used to ensure provision of good quality and comparable rehabilitation to all participants of a multi-centre randomised controlled trial comparing surgery with conservative treatment of proximal humeral fractures in adults. Methods These processes included the development of a patient information leaflet on self-care during sling immobilisation, the development of a basic treatment physiotherapy protocol that received input and endorsement by specialist physiotherapists providing patient care, and establishing an expectation for the provision of home exercises. Specially designed forms were also developed to facilitate reliable reporting of the physiotherapy care that patients received. Results All three initiatives were successfully implemented, alongside the measures to optimise the documentation of physiotherapy. Thus, all participating sites that recruited patients provided the sling immobilisation leaflet, all adhered to the physiotherapy protocol and all provided home exercises. There was exemplary completion of the physiotherapy forms that often reflected a complex patient care pathway. These data demonstrated equal and high access to and implementation of physiotherapy between groups, including the performance of home exercises. Conclusion In order to increase the validity and relevance of the evidence from trials of surgical interventions and meet international reporting standards, careful attention to study design, conduct and reporting of the intrinsic rehabilitation components is required. The involvement of rehabilitation specialists is crucial to achieving this. Cite this article: Bone Joint Res 2014;3:335–40.

A Systematic Review of Rehabilitation for Distal Radial Fractures in Adults

We undertook a systematic review of the evidence from randomised controlled trials for effectiveness of rehabilitation intervention(s) for adults with fractures of the distal radius. A comprehensive search yielded 12 eligible trials, which were assessed for methodological quality. This paper presents the findings of these trials, which covered nine treatment comparisons, and explains why we concluded that there was insufficient evidence to inform practice.

Systematic Reviews, Meta-Analyses, and Methodology

To The Editor: We have been encouraged by the explicit emphasis on evidence-based orthopaedics in The Journal, and we read with great interest “Meta-Analyses in Orthopaedic Surgery. A Systematic Review of Their Methodologies” (83-A: 15-24, Jan. 2001), by Bhandari et al. This article raised some important points, one being that adherence to strict scientific methodology can limit bias and improve the validity of meta-analyses. However, we would like to comment on the methodology and consequent findings of their study. The first issue is their omission of relevant studies published in the Cochrane Database of Systematic Reviews. As Bhandari et al. stated, they consulted this database in their search for meta-analyses, yet some thirty to fifty systematic reviews available in this database in 1999 were not included, which we find puzzling. Omission of these reviews, which, if included, would have more than doubled the number of reviews of fracture treatment, results in a distorted picture of the information that is available to the orthopaedic specialist. Moreover, as acknowledged by Bhandari et al., there is evidence that these reviews have higher scientific quality than …