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. Cite this article: Bone Joint J 2017;99-B:383-92

In defence of reviews of small trials: underpinning the generation of evidence to inform practice

The value of systematic reviews of small trials has recently been questioned.[1] Contrary to the arguments of others who maintain that systematic reviews are crucial to avoiding waste[2], Roberts and Ker contend that systematic reviews of small trials "cause research waste" primarily because such reviews fail "to acknowledge the unreliability of small, single-centre trials".[1] We suggest that there is considerable awareness of the challenges of using small trials and that adherence tostandard Cochrane methods helps counter the concerns surrounding the inclusion of small trials. This editorial illustrates why Cochrane Reviews of small trials are of value and how they can act as important grounds and platforms for trials that are large and robust enough to inform practice. We look at recently updated Cochrane Reviews on the treatment of an increasingly common fracture and the commonest impairment after stroke.[3,4

Impact of the PROFHER trial findings on surgeons' clinical practice : An online questionnaire survey

OBJECTIVES: To explore whether orthopaedic surgeons have adopted the Proximal Fracture of the Humerus: Evaluation by Randomisation (PROFHER) trial results routinely into clinical practice. METHODS: A questionnaire was piloted with six orthopaedic surgeons using a 'think aloud' process. The final questionnaire contained 29 items and was distributed online to surgeon members of the British Orthopaedic Association and British Elbow and Shoulder Society. Descriptive statistics summarised the sample characteristics and fracture treatment of respondents overall, and grouped them by whether they changed practice based on PROFHER trial findings. Free-text responses were analysed qualitatively for emerging themes using Framework Analysis principles. RESULTS: There were complete responses from 265 orthopaedic and trauma surgeons who treat patients with proximal humeral fractures. Around half (137) had changed practice to various extents because of PROFHER, by operating on fewer PROFHER-eligible fractures. A third (43) of the 128 respondents who had not changed practice were already managing patients non-operatively. Those who changed practice were more likely to be younger, work in a trauma unit rather than a major trauma centre, be specialist shoulder surgeons and treat fewer PROFHER-eligible fractures surgically. This group gave higher scores when assessing validity and applicability of PROFHER. In contrast, a quarter of the non-changers were critical, sometimes emphatically, of PROFHER. The strongest theme that emerged overall was the endorsement of evidence-based practice. CONCLUSION: PROFHER has had an impact on surgeons' clinical practice, both through changing it, and through underpinning existing non-operative practice. Although some respondents expressed reservations about the trial, evidence from such trials was found to be the most important influence on surgeons' decisions to change practice.Cite this article: L. Jefferson, S. Brealey, H. Handoll, A. Keding, L. Kottam, I. Sbizzera, A. Rangan. Impact of the PROFHER trial findings on surgeons' clinical practice: An online questionnaire survey. Bone Joint Res 2017;6:590-599. DOI: 10.1302/2046-3758.610.BJR-2017-0170

Internal fixation and comparisons of different fixation methods for treating distal radial fractures in adults

Objectives: To evaluate the effectiveness of internal fixation for fractures of the distal radius in skeletally mature people. Additionally, to evaluate the relative effectiveness of different surgical methods of treating these fractures. More specifically, the authors compare the effectiveness of: • internal fixation versus conservative treatment; • different methods of internal fixation, including different techniques associated with inserting implants, different implants, and different types and durations of immobilisation after internal fixation; • different fixation methods (percutaneous pinning, external fixation, internal fixation); and different combinations of surgical methods; • different techniques (e.g. use of arthroscopy) and approaches (e.g. surgical repair of the triangular fibrocartilagenous complex (fibrous tissue which binds together the distal ends of the radius and ulnar) not already covered. The authors consider these outcomes primarily in terms of patient-assessed functional outcome and satisfaction, and other measures of function and impairment, pain and discomfort, the incidence of complications, anatomical deformity and use of resources. If data allows it, the authors intend to study the outcomes in different age groups and for different types of fractures, especially whether they are extra-articular or intra-articular

Prevention of falls and fall-related injuries in older people

As people get older, they may fall more often for a variety of reasons including problems with balance, poor vision, and dementia. About a third of community-dwelling people over 65 years old fall each year, and the incidence of falls, and fall related injuries, increases with age. Although less than 10% of falls in community-living older people result in a fracture, these are a significant source of morbidity and mortality. More commonly, falls result in minor injuries such as bruising and lacerations. They can also result in fear of falling and loss of confidence, and admission to a nursing home. Many risk factors appear to interact in older people who suffer fractures, and it is possible that fall-prevention strategies have limited effect on falls that result in injuries, or are ineffective in populations at a higher risk of injury. Interventions designed to reduce falls would require large effects to have an impact on the incidence of fractures. In the past, fall-prevention trials have not been adequately powered to detect effect on injury outcomes, and variation in the definition of these outcomes has hindered meta-analysis. The Prevention of Falls Network Europe (ProFaNE) consensus document recommending that fall-related fractures should be the injury outcome of choice should help to address this. The Cochrane Bone, Joint and Muscle Trauma Group has supported the production of the review ‘‘Interventions for preventing falls in elderly people’’, since it was first published in 1997. This review, which has been withdrawn from the Cochrane Database of Systematic Reviews, has been replaced by a review of interventions for preventing falls in community dwelling older people, and a second review of fall-prevention interventions in nursing care facilities and hospitals, which is nearing completion

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

Snowballing citations

In August 2015, one of us (HHGH) received an unsolicited email from the publishing company Elsevier announcing a citation of her short letter published in 2006.1 The letter had attempted to correct a considerable overestimate of the number of Cochrane reviews on rehabilitation interventions (figure⇓).1 Intrigued, she investigated further and found that, as of August 2015, this modest letter had had 62 citations, all of which related to meta-analyses of genetic risk factors. The first of these meta-analyses was published in 2009 and all the lead authors were based in China. Consistently, authors referenced the letter to support their use of the Cochran Q-statistic for exploring heterogeneity of effect sizes, rather than to highlight the need for Cochrane reviews on rehabilitation