BACKGROUND:Fractures of the proximal humerus, often termed shoulder fractures, are common injuries, especially in older people. The management of these fractures varies widely, including in the use of surgery. This is an update of a Cochrane Review first published in 2001 and last updated in 2015. OBJECTIVES:To assess the effects (benefits and harms) of treatment and rehabilitation interventions for proximal humeral fractures in adults. SEARCH METHODS:We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, trial registries, and bibliographies of trial reports and systematic reviews to September 2020. We updated this search in November 2021, but have not yet incorporated these results. SELECTION CRITERIA:We included randomised and quasi-randomised controlled trials that compared non-pharmacological interventions for treating acute proximal humeral fractures in adults.  DATA COLLECTION AND ANALYSIS: Pairs of review authors independently selected studies, assessed risk of bias and extracted data. We pooled data where appropriate and used GRADE for assessing the certainty of evidence for each outcome. We prepared a brief economic commentary for one comparison. MAIN RESULTS:We included 47 trials (3179 participants, mostly women and mainly aged 60 years or over) that tested one of 26 comparisons. Six comparisons were tested by 2 to 10 trials, the others by small single-centre trials only. Twelve studies evaluated non-surgical treatments, 10 compared surgical with non-surgical treatments, 23 compared two methods of surgery, and two tested timing of mobilisation after surgery. Most trials were at high risk of bias, due mainly to lack of blinding. We summarise the findings for four key comparisons below. Early (usually one week post injury) versus delayed (after three or more weeks) mobilisation for non-surgically-treated fractures Five trials (350 participants) made this comparison; however, the available data are very limited. Due to very low-certainty evidence from single trials, we are uncertain of the findings of better shoulder function at one year in the early mobilisation group, or the findings of little or no between-group difference in function at 3 or 24 months. Likewise, there is very low-certainty evidence of no important between-group difference in quality of life at one year. There was one reported death and five serious shoulder complications (1.9% of 259 participants), spread between the two groups, that would have required substantive treatment. Surgical versus non-surgical treatment Ten trials (717 participants) evaluated surgical intervention for displaced fractures (66% were three- or four-part fractures). There is high-certainty evidence of no clinically important difference between surgical and non-surgical treatment in patient-reported shoulder function at one year (standardised mean difference (SMD) 0.10, 95% confidence interval (CI) -0.07 to 0.27; 7 studies, 552 participants) and two years (SMD 0.06, 95% CI -0.13 to 0.25; 5 studies, 423 participants). There is moderate-certainty evidence of no clinically important between-group difference in patient-reported shoulder function at six months (SMD 0.17, 95% CI -0.04 to 0.38; 3 studies, 347 participants). There is high-certainty evidence of no clinically important between-group difference in quality of life at one year (EQ-5D (0: dead to 1: best quality): mean difference (MD) 0.01, 95% CI -0.02 to 0.04; 6 studies, 502 participants). There is low-certainty evidence of little between-group difference in mortality: one of the 31 deaths was explicitly linked with surgery (risk ratio (RR) 1.35, 95% CI 0.70 to 2.62; 8 studies, 646 participants). There is low-certainty evidence of a higher risk of additional surgery in the surgery group (RR 2.06, 95% CI 1.21 to 3.51; 9 studies, 667 participants). Based on an illustrative risk of 35 subsequent operations per 1000 non-surgically-treated patients, this indicates an extra 38 subsequent operations per 1000 surgically-treated patients (95% CI 8 to 94 more). Although there was low-certainty evidence of a higher overall risk of adverse events after surgery, the 95% CI also includes a slightly increased risk of adverse events after non-surgical treatment (RR 1.46, 95% CI 0.92 to 2.31; 3 studies, 391 participants). Open reduction and internal fixation with a locking plate versus a locking intramedullary nail Four trials (270 participants) evaluated surgical intervention for displaced fractures (63% were two-part fractures). There is low-certainty evidence of no clinically important between-group difference in shoulder function at one year (SMD 0.15, 95% CI -0.12 to 0.41; 4 studies, 227 participants), six months (Disability of the Arm, Shoulder, and Hand questionnaire (0 to 100: worst disability): MD -0.39, 95% CI -4.14 to 3.36; 3 studies, 174 participants), or two years (American Shoulder and Elbow Surgeons score (ASES) (0 to 100: best outcome): MD 3.06, 95% CI -0.05 to 6.17; 2 studies, 101 participants). There is very low-certainty evidence of no between-group difference in quality of life (1 study), and of little difference in adverse events (4 studies, 250 participants) and additional surgery (3 studies, 193 participants). Reverse total shoulder arthroplasty (RTSA) versus hemiarthroplasty There is very low-certainty evidence from two trials (161 participants with either three- or four-part fractures) of no or minimal between-group differences in self-reported shoulder function at one year (1 study) or at two to three years' follow-up (2 studies); or in quality of life at one year or at two or more years' follow-up (1 study). Function at six months was not reported. Of 10 deaths reported by one trial (99 participants), one appeared to be surgery-related. There is very low-certainty evidence of a lower risk of complications after RTSA (2 studies). Ten people (6.2% of 161 participants) had a reoperation; all eight cases in the hemiarthroplasty group received a RTSA (very low-certainty evidence). AUTHORS' CONCLUSIONS:There is high- or moderate-certainty evidence that, compared with non-surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures. It may increase the need for subsequent surgery. The evidence is absent or insufficient for people aged under 60 years, high-energy trauma, two-part tuberosity fractures or less common fractures, such as fracture dislocations and articular surface fractures. There is insufficient evidence from randomised trials to inform the choices between different non-surgical, surgical or rehabilitation interventions for these fractures.

This article is based on a Cochrane Review published in the Cochrane Database of Systematic Reviews (CDSR) 2022, Issue 6,DOI: 10.1002/14651858.CD000434.pub5. (see www.cochranelibrary.com for information).

BACKGROUND:Hip fracture is a major cause of morbidity and mortality in older people and its impact on society is substantial. OBJECTIVES:To examine the effects of multidisciplinary rehabilitation, in either inpatient or ambulatory care settings, for older patients with hip fracture. SEARCH STRATEGY:We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register (April 2009), The Cochrane Library (2009, Issue 2), MEDLINE and EMBASE (both to April 2009). SELECTION CRITERIA:Randomised and quasi-randomised trials of post-surgical care using multidisciplinary rehabilitation of older patients (aged 65 years or over) with hip fracture. The primary outcome, 'poor outcome' was a composite of mortality and decline in residential status at long-term (generally one year) follow-up. DATA COLLECTION AND ANALYSIS:Trial selection was by consensus. Two review authors independently assessed trial quality and extracted data. Data were pooled where appropriate. MAIN RESULTS:The 13 included trials involved 2498 older, usually female, patients who had undergone hip fracture surgery. Though generally well conducted, some trials were at risk of bias such as from imbalances in key baseline characteristics.There was substantial clinical heterogeneity in the trial interventions and populations. Multidisciplinary rehabilitation was provided primarily in an inpatient setting in 11 trials. Pooled results showed no statistically significant difference between intervention and control groups for poor outcome (risk ratio 0.89; 95% confidence interval 0.78 to 1.01), mortality (risk ratio 0.90, 95% confidence interval 0.76 to 1.07) or hospital readmission. Individual trials found better results, often short-term only, in the intervention group for activities of daily living and mobility. There was considerable heterogeneity in length of stay and cost data. Three trials reporting carer burden showed no evidence of detrimental effect from the intervention. Overall, the evidence indicates that multidisciplinary rehabilitation is not harmful.The trial comparing primarily home-based multidisciplinary rehabilitation with usual inpatient care found marginally improved function and a clinically significantly lower burden for carers in the intervention group. Participants of this group had shorter hospital stays, but longer periods of rehabilitation. One trial found no significant effect from doubling the number of weekly contacts at the patient's home from a multidisciplinary rehabilitation team. AUTHORS' CONCLUSIONS:While there was a tendency to a better overall result in patients receiving multidisciplinary inpatient rehabilitation, these results were not statistically significant.Future trials of multidisciplinary rehabilitation should aim to establish both effectiveness and cost effectiveness of multidisciplinary rehabilitation overall, rather than evaluate its components.

Background Fracture of the distal radius is a common clinical problem. A key method of surgical fixation is percutaneous pinning, involving the insertion of wires through the skin to stabilise the fracture. This is an update of a Cochrane Review published in 2007. Objectives To assess the effects (benefits and harms) of percutaneous pinning versus cast immobilisation alone and of different methods and techniques of percutaneous pinning, modalities or duration of immobilisation after pinning, and methods or timing of pin or wire removal for treating fractures of the distal radius in adults. Our primary focus was on dorsally displaced fractures. Search methods We searched the Cochrane Bone, Joint and Muscle Trauma Group Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, trial registers, conference proceedings and reference lists of articles up to June 2019. Selection criteria Randomised or quasi-randomised controlled clinical trials involving adults with a fracture of the distal radius, which compared percutaneous pinning with non-surgical treatment or different aspects of percutaneous pinning. Our main outcomes were patient-reported function at the short term (up to three months), medium term (three up to 12 months) and long term (greater than 12 months); overall numbers of participants with complications requiring secondary treatment and any complication; grip strength and health-related quality of life at 12 months. Data collection and analysis At least two review authors independently performed study screening and selection, 'Risk of bias' assessment and data extraction. We pooled data where appropriate and used GRADE for assessing the quality of evidence for each outcome. Main results We included 21 randomised controlled trials (RCTs) and five quasi-RCTs, involving 1946 generally older and female adults with dorsally displaced and potentially or evidently unstable distal radial fractures. Trial populations varied but the majority of studies reported mean ages in the sixth decade or older. All trials were at high risk of bias, invariably performance bias - which for most trials reflected the impracticality of blinding care providers or participants to treatment allocation - and often detection bias and selective reporting bias. Allocation concealment was secure in one trial only. All trials reported outcomes incompletely. The studies tested one of 10 comparisons. In the following, we report on those of the main outcomes for which evidence was available. No subgroup analysis, such as by pinning methods, was viable. Eleven heterogeneous trials involving 917 participants compared percutaneous pinning with plaster cast immobilisation after closed reduction of the fracture. The quality of the evidence was very low for all reported outcomes. Thus, we are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported function, measured using the DASH questionnaire, at six weeks or six months (incomplete data from one trial). Overall numbers of participants with complications were not reported. Redisplacement resulting in secondary treatment occurred on average in 12% (range 3.3% to 75%) of participants treated by cast alone (six trials) whereas pin tract infection requiring antibiotics and, often, early wire removal, occurred on average in 7.7% (range 0% to 15%) of pinning group participants (seven trials). We are uncertain whether pinning makes a difference to the incidence of complex regional pain syndrome, reported in four studies. Although two studies found finger stiffness after cast removal was less common after pinning (20% versus 36%), the treatment implications were not reported. Other reported complications were mainly surgery-related. Based on incomplete data or qualitative statements from only four studies, we are uncertain of the effects of pinning on grip strength at 12 months. We are uncertain if percutaneous pinning compared with plaster cast alone makes any difference to patient-reported quality of life at four months (one study). Five comparisons of different pinning methods were made by six trials in all. One of these trials, which reported results for 96 participants, compared Kapandji intrafocal pinning (2 or 3 wires) with early mobilisation versus trans-styloid fixation (2 wires) with six weeks cast immobilisation. We are uncertain whether Kapandji pinning slightly increases the risk of superficial radial nerve symptoms or complex regional pain syndrome, or whether it makes a difference in grip strength at 12 months (very low-quality evidence). Two small trials using two distinct pinning techniques compared biodegradable pins versus metal pins in 70 participants. Although very low-quality evidence, the extra demands at surgery of insertion of biodegradable pins and excess of serious complications (e.g. severe osteolytic reactions) associated with biodegradable material are important findings. Three poorly-reported trials involving 168 participants compared burying of wire ends versus leaving them exposed. We are uncertain whether burying of wires reduces the incidence of superficial infection (very low-quality evidence). There is low-quality evidence that burying of wires may be associated with a higher risk of requiring more invasive treatment for wire removal. Four small trials compared different types or duration of postoperative immobilisation. Very low-quality evidence of small between-group differences in individual complications and grip strength at 17 weeks, means we are uncertain of the effects of positioning the wrist in dorsiflexion versus palmar flexion during cast immobilisation following pinning of redisplaced fractures (one trial; 60 participants). Three small heterogeneous trials compared cast immobilisation for one week (early mobilisation) versus four or six weeks after percutaneous pinning in 170 people. Although we note one trial using Kapandji pinning reported more complications in the early group, the very low-quality evidence means there is uncertainty of the effects of early mobilisation on overall and individual complications, or grip strength at 12 months. No trials tested different methods for, or timing of, pin/wire removal. Authors' conclusions Overall, there is insufficient RCT evidence to inform on the role of percutaneous pinning versus cast immobilisation alone or associated treatment decisions such as method of pinning, burying or not of wire ends, wrist position and duration of immobilisation after pinning. Although very low-quality evidence, the serious complications associated with biodegradable materials is noteworthy. We advise waiting on the results of a large ongoing study comparing pinning with plaster cast treatment as these could help inform future research.

Background Surgeon and patient treatment preferences are important threats to the internal and external validity of surgical trials such as PROFHER, which compared surgical versus non-surgical treatment for displaced fractures of the proximal humerus in adults. We explored the treatment preferences expressed by surgeons and patients in the trial and how these impacted on patient selection, trial conduct and patient outcome. Methods A series of exploratory secondary analyses of the PROFHER trial data were undertaken. We reviewed the extent of surgeon and patient treatment preferences (surgery or not surgery) at screening ( n = 1250) as well as prior preference (including no preference) of randomised patients ( n = 250), and assessed their impact on recruitment and adherence to follow-up and rehabilitation. Changes in treatment after 2 years’ follow-up were explored. Patient preference and characteristics associated with trial inclusion or treatment preference ( t test, chi-squared test, Wilcoxon rank-sum test) were included as treatment interaction terms in the primary trial analysis of shoulder functioning (Oxford Shoulder Score, OSS). Results Surgeons excluded 17% of otherwise eligible patients based on lack of equipoise; these patients had less complex fractures ( p < 0.001) and tended to be older ( p = 0.062). Surgeons were more likely to recommend surgery for patients under 65 years of age ( p = 0.059) and who had injured their right shoulder ( p = 0.052). Over half of eligible patients (56%) did not consent to take part in the trial; these patients tended to be older ( p = 0.022), with a preference for not surgery (74%; which was associated with older age, p = 0.039). There were no differential treatment effects ( p value of interaction) for shoulder functioning (OSS) based on subgroups of patient preference ( p = 0.751), age group ( p = 0.264), fracture type ( p = 0.954) and shoulder dominance ( p = 0.850). Patients who were randomised to their preferred treatment had better follow-up rates (94 vs 84% at 2 years) and treatment adherence (90 vs 83% reported completing home exercises). Patients who were not randomised to their preferred treatment were more likely to change their treatment preference at 24 months (60 vs 26%). Conclusions The robustness of the PROFHER trial findings was confirmed against possible bias introduced by surgeon and patient preferences. The importance of collecting preference data is highlighted. Trial registration ISRCTN50850043 . Registered on 25 March 2008.

BACKGROUND:Knowledge about Minimal Important Differences (MIDs) is essential for the interpretation of continuous outcomes, especially patient-reported outcome measures (PROMS).OBJECTIVE:The aim of this study was to estimate the MID for the Western Ontario Rotator Cuff Index (WORC: score 0 (best) to 2100 (worst disability)) in adults with shoulder pain associated with partial-thickness rotator cuff tears, 'symptomatic PTTs', undergoing conservative treatment with physiotherapy.DESIGN:A prospectively-designed anchor-based MID analysis using data from a prospective prognostic study with a three-month follow-up conducted within an outpatient care setting in Germany.METHODS:The MID was estimated using data from 64 adults with atraumatic symptomatic PTTs who underwent three months of conservative treatment with physiotherapy. The anchor was a seven-point Global Perceived Change (GPC) scale.RESULTS:Based on a definition of the MID being the threshold of "being (at least slightly) improved" with a probability nearest to 0.90 (i.e. 9 of 10 patients achieving the MID), the MID for the WORC was estimated as -300 for 'improved' shoulder-related disability in 9 out of 10 patients (95% CI 8 out of 10 patients to everyone) undergoing three months of exercise-based physiotherapy for symptomatic PTTs.CONCLUSIONS:This is the first published MID estimate for the WORC in adults with symptomatic PTTs of the rotator cuff undergoing typical treatment comprising conservative treatment with physiotherapy. The conceptual framework for interpretation facilitates its use in similar clinical contexts.

Background Rotator cuff disorders represent the commonest type of painful shoulder complaints in clinical practice. Although conservative treatment including physiotherapy is generally recommended as first-line treatment, little is known about the precise treatment indications for subgroups of rotator cuff disorders, particularly people with shoulder pain associated with partial-thickness tears of the rotator cuff, PTTs: “symptomatic PPTs”. The aim of this study was to develop a prognostic model for predicting the outcome of a phase of conservative treatment primarily with physiotherapy in adults with symptomatic PTTs. Methods A prospective observational cohort study was conducted in an outpatient setting in Germany. Ten baseline factors were selected to evaluate nine pre-defined multivariable candidate prognostic models (each including between two and nine factors) in a cohort of adults with symptomatic atraumatic PTTs undergoing a three-month phase of conservative treatment primarily with physiotherapy. The primary outcome was change in the Western Ontario Rotator Cuff Index. The models were developed using linear regression and an information-theoretic analysis approach: Akaike’s Information Criterion (AIC C ). Results Eight candidate models were analyzed using data from 61 participants. Two “best models” were identified: smoking & pain catastrophizing and disability & pain catastrophizing. However, none of the models had a satisfactory performance or precision. Conclusions We could not determine a prognostic model with satisfactory performance and precision. Further high-quality prognostic model studies with larger samples are needed, but should be underpinned, and thus preceded, by robust research that enhances knowledge of relevant prognostic factors. Study registration DRKS00004462 . Registered 08 April 2014; retrospectively registered (prior to the analysis).

BACKGROUND:Wrist fractures, involving the distal radius, are the most common fractures in children. Most are buckle fractures, which are stable fractures, unlike greenstick and other usually displaced fractures. There is considerable variation in practice, such as the extent of immobilisation for buckle fractures and use of surgery for seriously displaced fractures. OBJECTIVES:To assess the effects (benefits and harms) of interventions for common distal radius fractures in children, including skeletally immature adolescents. SEARCH METHODS:We searched the Cochrane Bone, Joint and Muscle Trauma Group's Specialised Register, the Cochrane Central Register of Controlled Trials, MEDLINE, Embase, trial registries and reference lists to May 2018. SELECTION CRITERIA:We included randomised controlled trials (RCTs) and quasi-RCTs comparing interventions for treating distal radius fractures in children. We sought data on physical function, treatment failure, adverse events, time to return to normal activities (recovery time), wrist pain, and child (and parent) satisfaction. DATA COLLECTION AND ANALYSIS:At least two review authors independently performed study screening and selection, 'Risk of bias' assessment and data extraction. We pooled data where appropriate and used GRADE for assessing the quality of evidence for each outcome. MAIN RESULTS:Of the 30 included studies, 21 were RCTs, seven were quasi-RCTs and two did not describe their randomisation method. Overall, 2930 children were recruited. Typically, trials included more male children and reported mean ages between 8 and 10 years. Eight studies recruited buckle fractures, five recruited buckle and other stable fractures, three recruited minimally displaced fractures and 14 recruited displaced fractures, typically requiring closed reduction, typically requiring closed reduction. All studies were at high risk of bias, mainly reflecting lack of blinding. The studies made 14 comparisons. Below we consider five prespecified comparisons:Removable splint versus below-elbow cast for predominantly buckle fractures (6 studies, 695 children)One study (66 children) reported similar Modified Activities Scale for Kids - Performance scores (0 to 100; no disability) at four weeks (median scores: splint 99.04; cast 99.11); low-quality evidence. Thirteen children needed a change or reapplication of device (splint 5/225; cast 8/219; 4 studies); very low-quality evidence. One study (87 children) reported no refractures at six months. One study (50 children) found no between-group difference in pain during treatment; very low-quality evidence. Evidence was absent (recovery time), insufficient (children with minor complications) or contradictory (child or parent satisfaction). Two studies estimated lower healthcare costs for removable splints.Soft or elasticated bandage versus below-elbow cast for buckle or similar fractures (4 studies, 273 children)One study (53 children) reported more children had no or only limited disability at four weeks in the bandage group; very low-quality evidence. Eight children changed device or extended immobilisation for delayed union (bandage 5/90; cast 3/91; 3 studies); very low-quality evidence. Two studies (139 children) reported no serious adverse events at four weeks. Evidence was absent, insufficient or contradictory for recovery time, wrist pain, children with minor complications, and child and parent satisfaction. More bandage-group participants found their treatment convenient (39 children).Removal of casts at home by parents versus at the hospital fracture clinic by clinicians (2 studies, 404 children, mainly buckle fractures)One study (233 children) found full restoration of physical function at four weeks; low-quality evidence. There were five treatment changes (home 4/197; hospital 1/200; 2 studies; very low-quality evidence). One study found no serious adverse effects at six months (288 children). Recovery time and number of children with minor complications were not reported. There was no evidence of a difference in pain at four weeks (233 children); low-quality evidence. One study (80 children) found greater parental satisfaction in the home group; low-quality evidence. One UK study found lower healthcare costs for home removal.Below-elbow versus above-elbow casts for displaced or unstable both-bone fractures (4 studies, 399 children)Short-term physical function data were unavailable but very low-quality evidence indicated less dependency when using below-elbow casts. One study (66 children with minimally displaced both-bone fractures) found little difference in ABILHAND-Kids scores (0 to 42; no problems) (mean scores: below-elbow 40.7; above-elbow 41.8); very low-quality evidence. Overall treatment failure data are unavailable, but nine of the 11 remanipulations or secondary reductions (366 children, 4 studies) were in the above-elbow group; very low-quality evidence. There was no refracture or compartment syndrome at six months (215 children; 2 studies). Recovery time and overall numbers of children with minor complications were not reported. There was little difference in requiring physiotherapy for stiffness (179 children, 2 studies); very low-quality evidence. One study (85 children) found less pain at one week for below-elbow casts; low-quality evidence. One study found treatment with an above-elbow cast cost three times more in Nepal.Surgical fixation with percutaneous wiring and cast immobilisation versus cast immobilisation alone after closed reduction of displaced fractures (5 studies, 323 children)Where reported, above-elbow casts were used. Short-term functional outcome data were unavailable. One study (123 children) reported similar ABILHAND-Kids scores indicating normal physical function at six months (mean scores: surgery 41.9; cast only 41.4); low-quality evidence. There were fewer treatment failures, defined as early or problematic removal of wires or remanipulation for early loss in position, after surgery (surgery 20/124; cast only 41/129; 4 studies; very low-quality evidence). Similarly, there were fewer serious advents after surgery (surgery 28/124; cast only 43/129; 4 studies; very low-quality evidence). Recovery time, wrist pain, and satisfaction were not reported. There was lower referral for physiotherapy for stiffness after surgery (1 study); very low-quality evidence. One USA study found similar treatment costs in both groups. AUTHORS' CONCLUSIONS:Where available, the quality of the RCT-based evidence on interventions for treating wrist fractures in children is low or very low. However, there is reassuring evidence of a full return to previous function with no serious adverse events, including refracture, for correctly-diagnosed buckle fractures, whatever the treatment used. The review findings are consistent with the move away from cast immobilisation for these injuries. High-quality evidence is needed to address key treatment uncertainties; notably, some priority topics are already being tested in ongoing multicentre trials, such as FORCE.

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.

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.

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 Kingdom's 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.

Smetek/Science Photo Library Two new and very different Cochrane Reviews illustrate some key pragmatic decisions taken to enhance the relevance of review findings to clinical practice. Both reviews required reconsideration of their scope. The adjustments related to the participants (in the case of a review of the management of children with ankle fractures) and the study design and control intervention (for a review of interventions for treating anterior cruciate ligament (ACL) injuries).[1, 2] Patterns of injury differ between children and adults, in part reflecting the different vulnerabilities of bone and soft tissues. A twist of the ankle that would commonly result in an ankle sprain in an adult is more likely to result in an ankle fracture in a child. Typically, these fractures involve growth plates, which are the last part of the bone to harden during development. A badly damaged growth plate may result in long‐term leg deformity. All three trials contributing evidence to the Cochrane Review of interventions for treating ankle fracture in children involved children with a diagnosis of a 'low‐risk' fracture involving the distal fibula.[1] Diagnosis is primarily based on clinical findings as the undisplaced growth plate fracture is usually not evident on plain X‐rays. These less serious fractures have a low risk for impairing growth. The three trials compared early mobilization (comprising ankle brace or bandage) with cast immobilization. In reports of two of the trials, the authors raised the possibility that some of injuries were not fractures. The third trial reported ultrasound examination conducted after randomization, the authors concluding that 19 of 34 followed‐up children had "definite evidence of growth‐plate injury".[3] As noted in the Cochrane Review, recent evidence from magnetic resonance imaging (MRI) studies of the main category of injury (Salter‐Harris type I growth plate fractures of the distal fibula) examined in the three trials strongly suggests that most of the injuries in these trials were sprains or bone bruises.[4, 5] An editorial accompanying one of the MRI studies observed that these results debunk the commonly held belief that "children don't get sprains".[6] This new evidence could be disconcerting for authors of a review on ankle fractures. However, the review authors argue that the key characteristic of the injuries included in the trials is that they heal without deformity and thus "accurate diagnosis of this group of low‐risk ankle injuries may be academic". The role of surgery is the focus of many Cochrane Reviews of musculoskeletal trauma, including ACL rupture. For more serious musculoskeletal injuries, surgery promises better restoration of anatomy, better stability while healing takes place and in the long term, and the prospect of earlier mobilization and return to function. However, these aims may not be achieved, and surgery comes at the risk of surgery‐related complications, such as infection and iatrogenic injury. Conducting randomized trials comparing surgical with non‐surgical (conservative) treatment is especially challenging, with strong treatment preferences of both clinicians and patients being major barriers to recruitment, adherence to treatment allocation and ultimately to trial success. ACL injuries are common sports‐related knee injuries. Definitive treatment is either non‐surgical, primarily a structured exercise programme, or surgical, typically ACL reconstruction followed by a structured exercise programme. ACL reconstruction, which has superseded surgical repair of the ACL, involves the replacement of the ACL by a tendon graft that is often extracted from the patient's leg. In 2006, about 130,000 ACL reconstructions were carried out in the USA alone, and trends show increasing surgery, particularly in adolescents.[7] In contrast to the relatively abundant literature on different approaches to ACL reconstruction, a new Cochrane Review found just one trial comparing ACL reconstruction plus rehabilitation versus rehabilitation alone.[2] This reported the results of 121 young adults with acute ACL injuries. Many of the participants had other knee injuries (e.g. meniscal tears) that were treated surgically.[8] The need for surgery (concurrent or separate) for these concomitant injuries in both groups is the first lapse from a pure surgery versus non‐surgery study design. However, the main deviation, built into the study design, was a formal option for subsequent (delayed) ACL reconstruction in the non‐surgical group if chosen by the participant and provided prespecified criteria relating to knee instability were met. This can be considered as a formal recognition of a potential clinical sequel of failed conservative treatment; ACL reconstruction is often performed for chronic knee instability related to 'ACL insufficiency'. A related qualitative study examining the preferences of 34 trial participants indicates the tactic of deferred surgery facilitated recruitment of patients with a strong preference for surgery.[9] These participants saw the trial as a means to circumvent waiting lists, which are a common feature of publicly funded healthcare systems. As noted in this study and reported elsewhere, trial participation often occurs in the absence of participant equipoise as well as misunderstanding by clinicians of equipoise.[10] Although opting for surgery in those participants allocated surgery could be strongly influenced by their prior preference for surgery, the trial results showed no difference between the treatment groups in patient‐reported outcomes of knee function. This may indicate, as shown in a trial comparing surgery versus conservative treatment for shoulder fractures, that participant preferences may not have importantly affected patient‐reported outcome assessment despite the unavoidable lack of blinding.[11] Both the reviews described here shifted away from the more exacting inclusion criteria initially implied in their scopes. This resulted in a change in the classification of injury in the first review and a move away from a strict interpretation of a surgery versus not‐surgery comparison in the second review. Both changes reflect clinical reality and thus increase the applicability of the review findings.

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.

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.

ConclusionCette étude pragmatique, excluant cependant de nombreuses situations cliniques courantes, ne montre pas de bénéfice clinique pertinent de la chirurgie versus traitement conservateur durant un suivi de 2 ans après une fracture déplacée de l’extrémité proximale de l’humérus chez l’adulte et confirme la mise en garde contre l’extension abusive des indications opératoires.

“Away Days” (trial promotion and training events for trial site personnel) are a well‐established method used by trialists to encourage engagement of research sites in the recruitment of patients to multicenter randomized controlled trials (RCTs). We explored the use of Away Days in multicenter RCTs and analyzed the effect on patient recruitment in a case study.

This leaflet is to remind you of the advice on self-care that you will receive from your hospital staff. Members of staff will be happy to explain any of the matters raised in this leaflet and you can also ask your family doctor (GP) for further advice when you have left hospital.This leaflet covers the first few weeks after your injury when your arm is in a sling. People are usually advised to wear their sling for about three weeks. The sling will ease the pain and help the bone and soft tissues to heal, so it is important that you wear it both day and night. The sling should support the weight of your arm. In some hospitals, depending on the consultant’s preference, the sling is secured by a ‘swathe’. In others, a ‘collar and cuff’is used instead of a sling. A well-positioned sling and swathe should look like diagram 1a. Diagram 1b shows a sling without a swathe, and diagram 1c shows a collar and cuff.

KTS Design/Science Photo Library 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 to standard 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] Proximal humeral fractures, often termed shoulder fractures, are serious injuries that occur predominantly in older adults. Typically, the less disrupted or displaced fractures are treated by supporting the injured arm in a sling while the fracture mends. More severe fractures, in which two or more bony fragments are displaced, are often treated surgically. This usually involves putting the fracture fragments back in place and fixing them with a metal plate and screws. In more complex fractures, the humeral head is sometimes replaced by an artificial joint; more rarely, the whole joint is replaced. Rehabilitation, which often involves a combination of physiotherapy and home exercises, can be protracted. Treatment outcome is frequently unsatisfactory and poor shoulder function and pain can result in long term disability and, in frailer adults, increased dependence such as a move to a nursing home. A Cochrane Review covering all interventions (including rehabilitation) for proximal humeral fractures was first published in 2001 and included nine small studies, with a further six listed as ongoing. This version and all six subsequent updates up to 2012 concluded that the evidence was insufficient to inform practice, noting in particular that "It remains unclear whether surgery, even for specific fracture types, will produce consistently better long term outcomes…"[5] The current version of the review, which includes 31 studies and lists a further 21 as ongoing, still notes the insufficiency of the evidence to most treatment decisions but now concludes: "There is high or moderate quality evidence that, compared with non‐surgical treatment, surgery does not result in a better outcome at one and two years after injury for people with displaced proximal humeral fractures involving the humeral neck and is likely to result in a greater need for subsequent surgery".[3] This turnabout is solely because of the inclusion of evidence from a sufficiently powered, good‐quality, multicentre randomised trial (the ProFHER trial) comparing surgery versus non‐surgical treatment of displaced fractures for which surgery is increasingly being performed.[6] The regularly updated Cochrane Review was instrumental in bringing about the delivery of this key primary research on the management of these injuries. By highlighting the deficiency in the available evidence for surgical intervention, the review underpinned the need for the ProFHER trial, which was funded by the UK National Institute of Health Research.[7] The review informed on the design of the ProFHER trial.[8] It endorsed the purposefully pragmatic design by highlighting the lack of robust evidence to inform treatment choices between different surgical or non‐surgical interventions. Insights were gained from the critical appraisal of the included trials (e.g. noting the need for validated patient‐reported outcome measures of function) and the contact with trialists of completed and abandoned trials (which highlighted frequent difficulties of recruitment in this area and reinforced the importance of a properly funded and professionally run multicentre trial). Updates of the external evidence were regularly provided to the ProFHER Trial Steering Committee in order to ascertain that there was no new evidence that required a reappraisal of the trial's protocol. Two updates of the review were published during the conduct of the ProFHER trial. The complete, open‐access report of the trial set the results into context of the available evidence to illustrate the contribution made by the trial to the overall evidence for the trial comparison.[9] The current update of the Cochrane Review incorporates the ProFHER findings and sets them into the context of the currently and potentially available evidence for other comparisons. The main results (two‐year follow‐up) of ProFHER are now available.[6] Five‐year follow‐up data are being collected for the ProFHER trial; the extension to follow‐up is also supported by the findings of the Cochrane Review. From being a neglected area served only by inadequate trials, a situation repeatedly highlighted by the Cochrane Review, the evidence for informing treatment decisions for these fractures is now accruing. Given that ProFHER is the first published of several multicentre prospectively registered trials testing treatment interventions for these fractures, the need to maintain this review is self‐evident. Loss of arm function is the most common impairment after stroke, and electromechanical (robot‐assisted) arm training has been proposed as an approach to improving recovery.[4] The Cochrane Review of this intervention has been regularly updated and documents the development and publication of many small trials.[4] The 2012 version included 19 trials with 666 participants in total;[10] and the current version describes 34 trials with an average size of 34 participants (range 8 to 127). The review authors considered that the quality of the evidence was low. They concluded that despite promising results for arm recovery scores, and in view of the clinical heterogeneity of trials, "there is still a need for well‐designed, large‐scale, multicentre studies to evaluate benefits and harms of electromechanical‐assisted arm training after stroke".[4] The UK National Institute of Health Research has commissioned such a trial, and researchers in Newcastle, UK, have successfully established the Robot Assisted Training for the Upper Limb after Stroke (RATULS) trial with a target recruitment of 720 participants.[11] Once again, the Cochrane Review was a key component in the development of the large, and hopefully definitive, trial. More broadly, a Cochrane overview of 31 reviews of different interventions for improving upper limb recovery after stroke has identified the shortage of high‐quality evidence to support clinical decision‐making in this clinical area and the need for larger definitive trials.[12] These examples of how Cochrane Reviews of inadequate‐sized trials have engendered and supported definitive studies are not atypical in the treatment of stroke or fractures. We are aware of many other examples in other areas, such as the direct influence of Cochrane Reviews, for example examining compression bandages[13], on a series of four definitive trials (VeNUS I, II, III and IV) on the management of venous ulcers. Many Cochrane Review authors will know the frustration of having to report there is insufficient evidence to produce firm conclusions despite an enormous effort of identifying and, sometimes repeatedly, reviewing a medley of small trials. However, as shown here, such reviews still serve a crucial role by highlighting the evidence deficiency for key questions that merit the investment of substantive research.[14]