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Background: Frozen shoulder is condition in which movement of the shoulder becomes restricted. It can be described as either primary (idiopathic) whereby the aetiology is unknown, or secondary, when it can be attributed to another cause. It is commonly a self-limiting condition, of approximately 1 to 3 years’ duration, though incomplete resolution can occur. Objectives: To evaluate the clinical effectiveness and cost-effectiveness of treatments for primary frozen shoulder, identify the most appropriate intervention by stage of condition and highlight any gaps in the evidence. Data sources: A systematic review was conducted. Nineteen databases and other sources including the Cumulative Index to Nursing and Allied Health (CINAHL), Science Citation Index, BIOSIS Previews and Database of Abstracts of Reviews of Effects (DARE) were searched up to March 2010 and EMBASE and MEDLINE up to January 2011, without language restrictions. MEDLINE, CINAHL and PsycINFO were searched in June 2010 for studies of patients’ views about treatment. Review methods: Randomised controlled trials (RCTs) evaluating physical therapies, arthrographic distension, steroid injection, sodium hyaluronate injection, manipulation under anaesthesia, capsular release or watchful waiting, alone or in combination were eligible for inclusion. Patients with primary frozen shoulder (with or without diabetes) were included. Quasi-experimental studies were included in the absence of RCTs and case series for manipulation under anaesthesia (MUA) and capsular release only. Full economic evaluations meeting the intervention and population inclusion criteria of the clinical review were included. Two researchers independently screened studies for relevance based on the inclusion criteria. One reviewer extracted data and assessed study quality; this was checked by a second reviewer. The main outcomes of interest were pain, range of movement, function and disability, quality of life and adverse events. The analysis comprised a narrative synthesis and pair-wise meta-analysis. A mixed-treatment comparison (MTC) was also undertaken. An economic decision model was intended, but was found to be implausible because of a lack of available evidence. Resource use was estimated from clinical advisors and combined with quality-adjusted life-years obtained through mapping to present tentative cost-effectiveness results. Results: Thirty-one clinical effectiveness studies and one economic evaluation were included. The clinical effectiveness studies evaluated steroid injection, sodium hyaluronate, supervised neglect, physical therapy (mainly physiotherapy), acupuncture, MUA, distension and capsular release. Many of the studies identified were at high risk of bias. Because of variation in the interventions and comparators few studies could be pooled in a meta-analysis. Based on single RCTs, and for some outcomes only, short-wave diathermy may be more effective than home exercise. High-grade mobilisation may be more effective than low-grade mobilisation in a population in which most patients have already had treatment. Data from two RCTs showed that there may be benefit from adding a single intra-articular steroid injection to home exercise in patients with frozen shoulder of

Objectives: To provide an overview of methods to identify postnatal depression (PND) in primary care and to assess their validity, acceptability, clinical effectiveness and cost-effectiveness, to model estimates of cost, to assess whether any method meets UK National Screening Committee (NSC) criteria and to identify areas for future research. Data sources: Searches of 20 electronic databases (including MEDLINE, CINAHL, PsycINFO, EMBASE, CENTRAL, DARE and CDSR), forward citation searching, personal communication with authors and searching of reference lists. Review methods: A generalised linear mixed model approach to the bivariate meta-analysis was undertaken for the validation review with quality assessment using QUADAS. Within the acceptability review, a textual narrative approach was employed to synthesise qualitative and quantitative research evidence. For the clinical and cost-effectiveness reviews methods outlined by the Centre for Reviews and Dissemination and the Cochrane Collaboration were followed. Probabilistic models were developed to estimate the costs associated with different identification strategies. Results: The Edinburgh Postnatal Depression Scale (EPDS) was the most frequently explored instrument across all of the reviews. In terms of test performance, postnatally the EPDS performed reasonably well: sensitivity ranged from 0.60 (specificity 0.97) to 0.96 (specificity 0.45) for major depression only; from 0.31 (specificity 0.99) to 0.91 (specificity 0.67) for major or minor depression; and from 0.38 (specificity 0.99) to 0.86 (specificity 0.87) for any psychiatric disorder. Evidence from the acceptability review indicated that, in the majority of studies, the EPDS was acceptable to women and health-care professionals when women were forewarned of the process, when the EPDS was administered in the home, with due attention to training, with empathetic skills of the health visitor and due consideration to positive responses to question 10 about self-harm. Suggestive evidence from the clinical effectiveness review indicated that use of the EPDS, compared with usual care, may lead to reductions in the number of women with depression scores above a threshold. In the absence of existing cost-effectiveness studies of PND identification strategies, a decision-analytic model was developed. The results of the base-case analysis suggested that use of formal identification strategies did not appear to represent value for money, based on conventional thresholds of cost-effectiveness used in the NHS. However, the scenarios considered demonstrated that this conclusion was primarily driven by the costs of false positives assumed in the base-case model. Conclusions: In light of the results of our evidence synthesis and decision modelling we revisited the examination of PND screening against five of the NSC criteria. We found that the accepted criteria for a PND screening programme were not currently met. The evidence suggested that there is a simple, safe, precise and validated screening test, in principle a suitable cut-off level could be defined and that the test is acceptable to the population. Evidence surrounding clinical and cost-effectiveness of methods to identify PND is lacking.: Further research should aim to identify the optimal identification strategy, in terms of key psychometric properties for postnatal populations. In particular, research comparing the performance of the Whooley and help questions, the EPDS and a generic depression measure would be informative. It would also be informative to identify the natural history of PND over time and to identify the clinical effectiveness of the most valid and acceptable method to identify PND. Further research within a randomised controlled trial would provide robust estimates of the clinical effectiveness.

Observer variation and error in the interpretation of medical images is substantial and has been described as Radiology's Achilles' heel. The enormous development in imaging technologies has brought with it an increase in the complexity and volume of images produced. There is also increased diversity as to who interprets medical images. Whilst the influence of the observer on diagnostic test performance is frequently ignored, there is evidence that this influences estimates of accuracy. Characteristics of observers that should be considered when designing systematic reviews of diagnostic test accuracy are: allocation of images to be read by observers; number, experience and training of observers; profession of observers; and assessment of observer variability and examination of its effect on test accuracy. This information could be used to inform study appraisal, data synthesis, and the investigation of sources of heterogeneity. Establishing the effect of the role of the observer on estimates of accuracy and explaining heterogeneity is important for informing the delivery of these potentially expensive and resource-intensive imaging technologies and the continuing debate about who should read the images. [ABSTRACT FROM AUTHOR]

The costs and effects of introducing selectively trained radiographers reporting accident and emergency (A&E) radiographs of the appendicular skeleton in a district general hospital were assessed using a retrospective controlled before and after design. Reference standard reports were compared with a random stratified sample of 200 A&E and 200 general practitioner (GP) reports before and after the intervention. GP reports were used as a non-intervention, non-equivalent control group. An A&E specialist registrar judged whether incorrect A&E reports might have a clinically important effect on patient management. The effect of incorrect A&E reports on outcome was assessed by patient re-attendance to the hospital because of missed abnormalities. The annual, average and incremental costs of radiographers and radiologists reporting A&E radiographs were calculated and a sensitivity analysis was undertaken. The introduction of the radiographers resulted in a 1% (95% CI -7.9 to 5.9) fall in A&E radiograph reporting accuracy and 11% (95% CI -33.7 to 11.3) reduction of cases in which incorrect A&E reports might have a clinically important effect on patient management. Only two A&E reports (one before and one after the intervention) affected patient outcome in that a fracture missed at the first visit resulted in patient re-attendance to the X-ray Department. There was a saving of 361 pounds per annum to the X-ray Department. In conclusion this study provides further evidence that selectively trained radiographers can accurately report A&E plain radiographs and at no additional cost. [ABSTRACT FROM AUTHOR]

Abstract Aims Frozen shoulder and proximal humeral fracture can cause pain, stiffness and loss of function. The impact of these symptoms on patients can be measured using the comprehensively validated, 12-item Oxford Shoulder Score (OSS). Evidence suggests that pain and function may have a differential impact on patients’ experience of shoulder conditions, and this may be important for clinical management. We therefore explored the factor structure of the OSS within the UK FROST and PROFHER trial populations. Methods We performed exploratory factor analysis (EFA), followed by confirmatory factor analysis (CFA), on baseline UK FROST data from 490 of the 503 trial participants. Data at 6 months post-randomisation were used for 228 of the 250 participants for the PROFHER trial. Results UK FROST factor extraction results, using Velicer's Minimum Average Partial and Horn's Parallel Analysis tests, suggested a unifactorial solution, but two factors were weakly indicated by the less reliable ‘Kaiser’s eigenvalue > 1’ and scree tests. We explored this further using EFA. Eight items (2 to 7, 9 and 10) loaded onto a ‘Function’ factor, three on a ‘Pain’ factor (1, 8 and 12) and item 11 cross-loaded. However, one- and two-factor models were rejected in CFA. Factor extraction of PROFHER data at 6 months demonstrated a single first-order factor solution, which was also subsequently rejected in CFA. Conclusion Insufficient evidence was found, within the constraints of the data available, to support the use of ‘Pain’ and ‘Function’ sub-scales of the OSS in either patient population.

Background: Older patients often experience safety issues when transitioning from hospital to home. The 'Your Care Needs You' (YCNY) intervention aims to support older people to 'know more' and 'do more' whilst in hospital so that they are better prepared for managing at home., Methods: A multi-centre cluster randomised controlled trial (cRCT) will evaluate the effectiveness and cost-effectiveness of the YCNY intervention. Forty acute hospital wards (clusters) in England from varying medical specialities will be randomised to deliver YCNY or care-as-usual on a 1:1 basis. The primary outcome will be unplanned hospital readmission rates within 30 days of discharge. This will be extracted from routinely collected data of at least 5440 patients (aged 75 years and older) discharged to their own homes during the 4- to 5-month YCNY intervention period. A nested cohort of up to 1000 patients will be recruited to the study to collect secondary outcomes via follow-up questionnaires at 5-, 30- and 90-day post-discharge. These will include measures of patient experience of transitions, patient-reported safety events, quality of life and healthcare resource use. Unplanned hospital readmission rates at 60 and 90 days of discharge will be collected from routine data. A process evaluation (primarily interviews and observations with patients, carers and staff) will be conducted to understand the implementation of the intervention and the contextual factors that shape this, as well as the intervention's underlying mechanisms of action. Fidelity of intervention delivery will also be assessed across all intervention wards., Discussion: This study will establish the effectiveness and cost-effectiveness of the YCNY intervention which aims to improve patient safety and experience for older people during transitions of care. The process evaluation will generate insights about how the YCNY intervention was implemented, what elements of the intervention work and for whom, and how to optimise its implementation so that it can be delivered with high fidelity in routine service contexts., Trial Registration: UK Clinical Research Network Portfolio: 44559; ISTCRN: ISRCTN17062524. Registered on 11/02/2020., (© 2023. BioMed Central Ltd., part of Springer Nature.)

Early large treatment effects can arise in small studies, which lessen as more data accumulate. This study aimed to retrospectively examine whether early treatment effects occurred for two multicentre orthopaedic randomized controlled trials (RCTs) and explore biases related to this. Included RCTs were ProFHER (PROximal Fracture of the Humerus: Evaluation by Randomisation), a two-arm study of surgery versus non-surgical treatment for proximal humerus fractures, and UK FROST (United Kingdom Frozen Shoulder Trial), a three-arm study of two surgical and one non-surgical treatment for frozen shoulder. To determine whether early treatment effects were present, the primary outcome of Oxford Shoulder Score (OSS) was compared on forest plots for: the chief investigator's (CI) site to the remaining sites, the first five sites opened to the other sites, and patients grouped in quintiles by randomization date. Potential for bias was assessed by comparing mean age and proportion of patients with indicators of poor outcome between included and excluded/non-consenting participants. No bias in treatment effect was observed overall for the CI site, or the first five sites, compared with the remaining sites in either trial. An early treatment effect on the OSS was observed for the first quintile of participants recruited to ProFHER only (clinically relevant difference of seven points). Selection bias for age was observed in the ProFHER trial only, with slightly younger patients being recruited into the study. Both trials showed some selection bias for markers of poor prognosis, although these did not appear to change over time. No bias in treatment effects overall were found at the CI or early sites set-up. An early treatment effect was found in one of the two trials, which was likely a chance effect as this did not continue during the study. Selection bias was observed in both RCTs, however this was minimal and did not impact on outcome., Competing Interests: A. Rangan reports grants from NIHR, AOUK, CIHR, DePuy Johnson & Johnson, and Wishbone Trust, NZ; and speaker payments and expenses from DePuy Johnson & Johnson, unrelated to this study. A. Rangan is also a trustee of the British Orthopaedic Association and the British Elbow & Shoulder Society, and a surgeon member of the NJR Steering Committee., (© 2023 Author(s) et al.)

Purpose: In order to enable cost-utility analysis of shoulder pain conditions and treatments, this study aimed to develop and evaluate mapping algorithms to estimate the EQ-5D health index from the Oxford Shoulder Score (OSS) when health outcomes are only assessed with the OSS., Methods: 5437 paired OSS and EQ-5D questionnaire responses from four national multicentre randomised controlled trials investigating different shoulder pathologies and treatments were split into training and testing samples. Separate EQ-5D-3L and EQ-5D-5L analyses were undertaken. Transfer to utility (TTU) regression (univariate linear, polynomial, spline, multivariable linear, two-part logistic-linear, tobit and adjusted limited dependent variable mixture models) and response mapping (ordered logistic regression and seemingly unrelated regression (SUR)) models were developed on the training sample. These were internally validated, and their performance evaluated on the testing sample. Model performance was evaluated over 100-fold repeated training-testing sample splits., Results: For the EQ-5D-3L analysis, the multivariable linear and splines models had the lowest mean square error (MSE) of 0.0415. The SUR model had the lowest mean absolute error (MAE) of 0.136. Model performance was greatest in the mid-range and best health states, and lowest in poor health states. For the EQ-5D-5L analyses, the multivariable linear and splines models had the lowest MSE (0.0241-0.0278) while the SUR models had the lowest MAE (0.105-0.113)., Conclusion: The developed models now allow accurate estimation of the EQ-5D health index when only the OSS responses are available as a measure of patient-reported health outcome., (© 2022. The Author(s).)

Aims: To achieve expert clinical consensus in the delivery of hydrodilatation for the treatment of primary frozen shoulder to inform clinical practice and the design of an intervention for evaluation., Methods: We conducted a two-stage, electronic questionnaire-based, modified Delphi survey of shoulder experts in the UK NHS. Round one required positive, negative, or neutral ratings about hydrodilatation. In round two, each participant was reminded of their round one responses and the modal (or 'group') response from all participants. This allowed participants to modify their responses in round two. We proposed respectively mandating or encouraging elements of hydrodilatation with 100% and 90% positive consensus, and respectively disallowing or discouraging with 90% and 80% negative consensus. Other elements would be optional., Results: Between 4 August 2020 and 4 August 2021, shoulder experts from 47 hospitals in the UK completed the study. There were 106 participants (consultant upper limb orthopaedic surgeons, n = 50; consultant radiologists, n = 52; consultant physiotherapist, n = 1; extended scope physiotherapists, n = 3) who completed round one, of whom 97 (92%) completed round two. No elements of hydrodilatation were "mandated" (100% positive rating). Elements that were "encouraged" (≥ 80% positive rating) were the use of image guidance, local anaesthetic, normal saline, and steroids to deliver the injection. Injecting according to patient tolerance, physiotherapy, and home exercises were also "encouraged". No elements were "discouraged" (≥ 80% negative rating) although using hypertonic saline was rated as being "disallowed" (≥ 90% negative rating)., Conclusion: In the absence of rigorous evidence, our Delphi study allowed us to achieve expert consensus about positive, negative, and neutral ratings of hydrodilatation in the management of frozen shoulder in a hospital setting. This should inform clinical practice and the design of an intervention for evaluation.Cite this article: Bone Jt Open  2022;3(9):701-709.

Objective: This review investigates whether the distribution of recruitment to multicentre randomised controlled trials (RCTs) fits the "Pareto Principle", i.e. 80% of participants are recruited by 20% of sites, or Price's Law, i.e. 50% of participants are recruited by the square root of the total number of sites., Methods: A review of HTA reports published between 2017 and 2019., Results: 40 RCTs conducted face-to-face recruitment, five recruited via mail-outs and one used both methods. For face-to-face recruitment (n = 41 studies), 80% of participants were recruited by the top recruiting 42.6% of sites; for mail-out methods (n = 6 studies) this was 52.0%. From the square root of sites, 51.3% and 31.8% of participants were recruited for the two recruitment approaches, respectively. Specifically, 3 (7.3%, 95% CI 2.5% to 19.4%) and 20 (48.8%, 95% CI 34.3% to 63.5%) RCTs that recruited face-to-face followed Pareto Principle and Price's Law, respectively. One mail-out recruitment study followed one of these principles, Price's Law. Chief Investigator (CI) sites (n = 24) in face-to-face recruitment studies recruited 18.1% of participants., Conclusion: Face-to-face recruitment to HTA-funded RCTs fits more closely to Price's Law than the Pareto Principle, with the CI's site recruiting nearly a fifth of participants. Since we focussed on HTA-funded RCTs with ≥9 recruiting sites and for which the recruitment method and number recruited by site were known, our findings are limited in their generalisability. However, this trend could be used as a guide to aid in estimating how many sites RCTs need. More accurate estimation may prevent the need for recruitment extensions., (Copyright © 2021. Published by Elsevier Inc.)

Background/aims: There is growing interest in the use of adaptive designs to improve the efficiency of clinical trials. We apply a Bayesian decision-theoretic model of a sequential experiment using cost and outcome data from the ProFHER pragmatic trial. We assess the model's potential for delivering value-based research., Methods: Using parameter values estimated from the ProFHER pragmatic trial, including the costs of carrying out the trial, we establish when the trial could have stopped, had the model's value-based stopping rule been used. We use a bootstrap analysis and simulation study to assess a range of operating characteristics, which we compare with a fixed sample size design which does not allow for early stopping., Results: We estimate that application of the model could have stopped the ProFHER trial early, reducing the sample size by about 14%, saving about 5% of the research budget and resulting in a technology recommendation which was the same as that of the trial. The bootstrap analysis suggests that the expected sample size would have been 38% lower, saving around 13% of the research budget, with a probability of 0.92 of making the same technology recommendation decision. It also shows a large degree of variability in the trial's sample size., Conclusions: Benefits to trial cost stewardship may be achieved by monitoring trial data as they accumulate and using a stopping rule which balances the benefit of obtaining more information through continued recruitment with the cost of obtaining that information. We present recommendations for further research investigating the application of value-based sequential designs.

Aims: This systematic review places a recently completed multicentre randomized controlled trial (RCT), UK FROST, in the context of existing randomized evidence for the management of primary frozen shoulder. UK FROST compared the effectiveness of pre-specified physiotherapy techniques with a steroid injection (PTSI), manipulation under anaesthesia (MUA) with a steroid injection, and arthroscopic capsular release (ACR). This review updates a 2012 review focusing on the effectiveness of MUA, ACR, hydrodilatation, and PTSI., Methods: MEDLINE, Embase, PEDro, Science Citation Index, Clinicaltrials.gov, CENTRAL, and the World Health Organization (WHO) International Clinical Trials Registry were searched up to December 2018. Reference lists of included studies were screened. No language restrictions applied. Eligible studies were RCTs comparing the effectiveness of MUA, ACR, PTSI, and hydrodilatation against each other, or supportive care or no treatment, for the management of primary frozen shoulder., Results: Nine RCTs were included. The primary outcome of patient-reported shoulder function at long-term follow-up (> 6 months and ≤ 12 months) was reported for five treatment comparisons across four studies. Standardized mean differences (SMD) were: ACR versus MUA: 0.21 (95% confidence interval (CI) 0.00 to 0.42), ACR versus supportive care: -0.13 (95% CI -1.10 to 0.83), and ACR versus PTSI: 0.33 (95% CI 0.07 to 0.59) and 0.25 (95% CI -0.34 to 0.85), all favouring ACR; MUA versus supportive care: 0 (95% CI -0.44 to 0.44) not favouring either; and MUA versus PTSI: 0.12 (95% CI -0.14 to 0.37) favouring MUA. None of these differences met the threshold of clinical significance agreed for the UK FROST and most confidence intervals included zero., Conclusion: The findings from a recent multicentre RCT provided the strongest evidence that, when compared with each other, neither PTSI, MUA, nor ACR are clinically superior. Evidence from smaller RCTs did not change this conclusion. The effectiveness of hydrodilatation based on four RCTs was inconclusive and there remains an evidence gap. Cite this article: Bone Jt Open  2021;2(9):773-784.

Aims: A pragmatic multicentre randomized controlled trial, UK FROzen Shoulder Trial (UK FROST), was conducted in the UK NHS comparing the cost-effectiveness of commonly used treatments for adults with primary frozen shoulder in secondary care., Methods: A cost utility analysis from the NHS perspective was performed. Differences between manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR), and early structured physiotherapy plus steroid injection (ESP) in costs (2018 GBP price base) and quality adjusted life years (QALYs) at one year were used to estimate the cost-effectiveness of the treatments using regression methods., Results: ACR was £1,734 more costly than ESP ((95% confidence intervals (CIs) £1,529 to £1,938)) and £1,457 more costly than MUA (95% CI £1,283 to £1,632). MUA was £276 (95% CI £66 to £487) more expensive than ESP. Overall, ACR had worse QALYs compared with MUA (-0.0293; 95% CI -0.0616 to 0.0030) and MUA had better QALYs compared with ESP (0.0396; 95% CI -0.0008 to 0.0800). At a £20,000 per QALY willingness-to-pay threshold, MUA had the highest probability of being cost-effective (0.8632) then ESP (0.1366) and ACR (0.0002). The results were robust to sensitivity analyses., Conclusion: While ESP was less costly, MUA was the most cost-effective option. ACR was not cost-effective. Cite this article: Bone Jt Open  2021;2(8):685-695.

Background: Recruitment of patients is one of the main challenges when designing and conducting randomised controlled trials (RCTs). Trials of rare injuries or those that include surgical interventions pose added challenges due to the small number of potentially eligible patients and issues with patient preferences and surgeon equipoise. We explore key issues to consider when recruiting to orthopaedic surgical trials from the perspective of staff and patients with the aim of informing the development of strategies to improve recruitment in future research., Design: Two qualitative process evaluations of a UK-wide orthopaedic surgical RCT (ACTIVE) and mixed methods randomised feasibility study (PRESTO). Qualitative semi-structured interviews were conducted and data was analysed thematically., Setting: NHS secondary care organisations throughout the UK. Interviews were undertaken via telephone., Participants: Thirty-seven health professionals including UK-based spinal and orthopaedic surgeons and individuals involved in recruitment to the ACTIVE and PRESTO studies (e.g. research nurses, surgeons, physiotherapists). Twenty-two patients including patients who agreed to participate in the ACTIVE and PRESTO studies (n=15) and patients that declined participation in the ACTIVE study (n=7) were interviewed., Results: We used a mixed methods systematic review of recruiting patients to randomised controlled trials as a framework for reporting and analysing our findings. Our findings mapped onto those identified in the systematic review and highlighted the importance of equipoise, randomisation, communication, patient's circumstances, altruism and trust in clinical and research teams. Our findings also emphasised the importance of considering how eligibility criteria are operationalised and the impact of complex patient pathways when recruiting to surgical trials. In particular, the influence of health professionals, who are not involved in trial recruitment, on patients' treatment preferences by suggesting they would receive a certain treatment ahead of recruitment consultations should not be underestimated., Conclusions: A wealth of evidence exploring factors affecting recruitment to randomised controlled trials exists. A methodological shift is now required to ensure that this evidence is used by all those involved in recruitment and to ensure that existing knowledge is translated into methods for optimising recruitment to future trials., Trial Registration: ACTIVE: ( ISRCTN98152560 ). Registered on 06/03/2018. PRESTO: ( ISRCTN12094890 ). Registered on 22/02/2018., (© 2021. The Author(s).)

Objectives: To explore the experiences and perceptions of trial participants and healthcare professionals in the UK Frozen Shoulder Trial (UK FROST), a multicentre randomised controlled trial that compared manipulation under anaesthesia (MUA), arthroscopic capsular release (ACR) with a 12-week early structured physiotherapy programme (ESP) in people with unilateral frozen shoulder referred to secondary care., Design: Nested qualitative study with semistructured interviews. We used constant comparison method to develop our themes., Setting: This qualitative study was nested within the UK FROST., Participants: 44 trial participants (ESP: 14; MUA: 15; ACR: 15), and 8 surgeons and 8 physiotherapists who delivered the treatments in the trial., Results: Trial participants found UK FROST treatments acceptable and satisfactory in terms of content, delivery and treatment benefits. Participants in all arms experienced improvements in pain, shoulder movements, and function. Participants said they would choose the same treatment that they received in the trial.Surgeons and physiotherapists felt that the content and delivery of UK FROST treatments was not significantly different to their routine practice except for the additional number of physiotherapy sessions offered in the trial. They had mixed feelings about the effectiveness of UK FROST treatments. Both stressed the value of including hydrodilatation as a comparator of other treatment options. Physiotherapists raised concerns about the capacity to deliver the number of UK FROST physiotherapy sessions in routine clinical settings.Shared perceptions of trial participants, surgeons and physiotherapists were: (1) Pain relief and return of shoulder movements and function are important outcomes and (2) Adherence to exercises leads to better outcomes., Conclusion: In general, our findings indicated that trial participants, and surgeons and physiotherapists who delivered the treatments had positive experiences and perceptions in the UK FROST. Early qualitative investigations to explore the feasibility of delivering treatments in real-world settings are suggested in future trials in the frozen shoulder., Trial Registration Number: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508. Registered on 25 July 2014; Results., Competing Interests: Competing interests: CS, FT, CPC declare no competing interests. LG, SB, MN report receiving grant from NIHR Health Technology Assessment programme that funded the trial. SL reports grants from the NIHR Health Technology Assessment Programme during the conduct of the study and was a member of several HTA boards from 2010 to 2015 and the NIHR CTU Standing Advisory Committee 2012–2016. AR reports other grants from NIHR HTA, ORUK and H2020 during the conduct of this study; and is a member of the NIHR i4i Challenge Awards Committee (2019-current). South Tees Hospitals NHS Foundation Trust receives educational grant to the department from DePuy Synthes (J&J). Institution also receives payment from DePuy Synthes (J&J) for Professor Rangan as the coordinating Investigator for the GLOBAL ICON Stemless Shoulder System Post Market Clinical Follow up Study: CT 1401. These are outside and unrelated to the submitted work., (© Author(s) (or their employer(s)) 2021. Re-use permitted under CC BY. Published by BMJ.)

Aims: A pilon fracture is a severe ankle joint injury caused by high-energy trauma, typically affecting men of working age. Although relatively uncommon (5% to 7% of all tibial fractures), this injury causes among the worst functional and health outcomes of any skeletal injury, with a high risk of serious complications and long-term disability, and with devastating consequences on patients' quality of life and financial prospects. Robust evidence to guide treatment is currently lacking. This study aims to evaluate the clinical and cost-effectiveness of two surgical interventions that are most commonly used to treat pilon fractures., Methods: A randomized controlled trial (RCT) of 334 adult patients diagnosed with a closed type C pilon fracture will be conducted. Internal locking plate fixation will be compared with external frame fixation. The primary outcome and endpoint will be the Disability Rating Index (a patient self-reported assessment of physical disability) at 12 months. This will also be measured at baseline, three, six, and 24 months after randomization. Secondary outcomes include the Olerud and Molander Ankle Score (OMAS), the five-level EuroQol five-dimenison score (EQ-5D-5L), complications (including bone healing), resource use, work impact, and patient treatment preference. The acceptability of the treatments and study design to patients and health care professionals will be explored through qualitative methods., Discussion: The two treatments being compared are the most commonly used for this injury, however there is uncertainty over which is most clinically and cost-effective. The Articular Pilon Fracture (ACTIVE) Trial is a sufficiently powered and rigorously designed study to inform clinical decisions for the treatment of adults with this injury. Cite this article: Bone Jt Open  2021;2(3):150-163.

Background: Frozen shoulder causes pain and stiffness. It affects around 10% of people in their fifties and is slightly more common in women. Costly and invasive surgical interventions are used, without high-quality evidence that these are effective., Objectives: To compare the clinical effectiveness and cost-effectiveness of three treatments in secondary care for adults with frozen shoulder; to qualitatively explore the acceptability of these treatments to patients and health-care professionals; and to update a systematic review to explore the trial findings in the context of existing evidence for the three treatments., Design: This was a pragmatic, parallel-group, multicentre, open-label, three-arm, randomised superiority trial with unequal allocation (2 : 2 : 1). An economic evaluation and a nested qualitative study were also carried out., Setting: The orthopaedic departments of 35 hospitals across the UK were recruited from April 2015, with final follow-up in December 2018., Participants: Participants were adults (aged ≥ 18 years) with unilateral frozen shoulder, characterised by restriction of passive external rotation in the affected shoulder to < 50% of the opposite shoulder, and with plain radiographs excluding other pathology., Interventions: The inventions were early structured physiotherapy with a steroid injection, manipulation under anaesthesia with a steroid injection and arthroscopic capsular release followed by manipulation. Both of the surgical interventions were followed with post-procedural physiotherapy., Main Outcome Measures: The primary outcome and end point was the Oxford Shoulder Score at 12 months post randomisation. A difference of 5 points between early structured physiotherapy and manipulation under anaesthesia or arthroscopic capsular release or of 4 points between manipulation under anaesthesia and arthroscopic capsular release was judged clinically important., Results: The mean age of the 503 participants was 54 years; 319 were female (63%) and 150 had diabetes (30%). The primary analyses comprised 473 participants (94%). At the primary end point of 12 months, participants randomised to arthroscopic capsular release had, on average, a statistically significantly higher (better) Oxford Shoulder Score than those randomised to manipulation under anaesthesia (2.01 points, 95% confidence interval 0.10 to 3.91 points; p  = 0.04) or early structured physiotherapy (3.06 points, 95% confidence interval 0.71 to 5.41 points; p  = 0.01). Manipulation under anaesthesia did not result in statistically significantly better Oxford Shoulder Score than early structured physiotherapy (1.05 points, 95% confidence interval -1.28 to 3.39 points; p  = 0.38). No differences were deemed of clinical importance. Serious adverse events were rare but occurred in participants randomised to surgery (arthroscopic capsular release, n  = 8; manipulation under anaesthesia, n  = 2). There was, however, one serious adverse event in a participant who received non-trial physiotherapy. The base-case economic analysis showed that manipulation under anaesthesia was more expensive than early structured physiotherapy, with slightly better utilities. The incremental cost-effectiveness ratio for manipulation under anaesthesia was £6984 per additional quality-adjusted life-year, and this intervention was probably 86% cost-effective at the threshold of £20,000 per quality-adjusted life-year. Arthroscopic capsular release was more costly than early structured physiotherapy and manipulation under anaesthesia, with no statistically significant benefit in utilities. Participants in the qualitative study wanted early medical help and a quicker pathway to resolve their shoulder problem. Nine studies were identified from the updated systematic review, including UK FROST, of which only two could be pooled, and found that arthroscopic capsular release was more effective than physiotherapy in the long-term shoulder functioning of patients, but not to the clinically important magnitude used in UK FROST., Limitations: Implementing physiotherapy to the trial standard in clinical practice might prove challenging but could avoid theatre use and post-procedural physiotherapy. There are potential confounding effects of waiting times in the trial., Conclusions: None of the three interventions was clearly superior. Early structured physiotherapy with a steroid injection is an accessible and low-cost option. Manipulation under anaesthesia is the most cost-effective option. Arthroscopic capsular release carries higher risks and higher costs., Future Work: Evaluation in a randomised controlled trial is recommended to address the increasing popularity of hydrodilatation despite the paucity of high-quality evidence., Trial Registration: Current Controlled Trials ISRCTN48804508., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 71. See the NIHR Journals Library website for further project information.

Background: Scaphoid fractures account for 90% of carpal fractures and occur predominantly in young men. Immediate surgical fixation of this fracture has increased., Objective: To compare the clinical effectiveness and cost-effectiveness of surgical fixation with cast treatment and early fixation in adults with scaphoid waist fractures that fail to unite., Design: Multicentre, pragmatic, open-label, parallel two-arm randomised controlled trial with an economic evaluation and a nested qualitative study., Setting: Orthopaedic departments of 31 hospitals in England and Wales recruited from July 2013, with final follow-up in September 2017., Participants: Adults (aged ≥ 16 years) presenting within 2 weeks of injury with a clear, bicortical fracture of the scaphoid waist on plain radiographs., Interventions: Early surgical fixation using Conformité Européenne-marked headless compression screws. Below-elbow cast immobilisation for 6-10 weeks and urgent fixation of confirmed non-union., Main Outcome Measures: The primary outcome and end point was the Patient-Rated Wrist Evaluation total score at 52 weeks, with a clinically relevant difference of 6 points. Secondary outcomes included Patient-Rated Wrist Evaluation pain and function subscales, Short Form questionnaire 12-items, bone union, range of movement, grip strength, complications and return to work., Results: The mean age of 439 participants was 33 years; 363 participants were male (83%) and 269 participants had an undisplaced fracture (61%). The primary analysis was on 408 participants with valid Patient-Rated Wrist Evaluation outcome data for at least one post-randomisation time point (surgery, n  = 203 of 219; cast, n  = 205 of 220). There was no clinically relevant difference in the Patient-Rated Wrist Evaluation total score at 52 weeks: the mean score in the cast group was 14.0 (95% confidence interval 11.3 to 16.6) and in the surgery group was 11.9 (95% confidence interval 9.2 to 14.5), with an adjusted mean difference of -2.1 in favour of surgery (95% confidence interval -5.8 to 1.6; p  = 0.27). The non-union rate was low (surgery group, n  = 1; cast group, n  = 4). Eight participants in the surgery group had a total of 11 reoperations and one participant in the cast group required a reoperation for non-union. The base-case economic analysis at 52 weeks found that surgery cost £1295 per patient more (95% confidence interval £1084 to £1504) than cast treatment. The base-case analysis of a lifetime-extrapolated model confirmed that the cast treatment pathway was more cost-effective. The nested qualitative study identified patients' desire to have a 'sense of recovering', which surgeons should address at the outset., Limitation: There were 17 participants who had initial cast treatment and surgery for confirmed non-union, which in 14 cases was within 6 months from randomisation and in three cases was after 6 months. Three of the four participants in the cast group who had a non-union at 52 weeks were not offered surgery., Conclusions: Adult patients with an undisplaced or minimally displaced scaphoid waist fracture should have cast immobilisation and suspected non-unions immediately confirmed and urgently fixed. Patients should be followed up at 5 years to investigate the effect of partial union, degenerative arthritis, malunion and screw problems on their quality of life., Trial Registration: Current Controlled Trials ISRCTN67901257., Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment ; Vol. 24, No. 52. See the NIHR Journals Library website for further project information.

Objectives: The objective of this study was to assess whether timing of short messaging service (SMS) reminders improved postal questionnaire return rates from participants in a randomized controlled trial (RCT)., Study Design and Setting: A Study Within A Trial (SWAT) embedded in a multicenter RCT evaluating three treatments for the frozen shoulder. Participants who provided a mobile telephone number were randomized to either prenotification SMS on the day of the questionnaire mail-out or postnotification SMS 4 days after questionnaire mail-out for the 3-month follow-up. The primary outcome was the proportion of participants who returned a valid questionnaire. A systematic review was undertaken to identify other embedded trials to perform a meta-analysis., Results: Of the 269 participants, 122/135 (90.4%) returned a valid questionnaire in the prenotification arm and 119/134 (88.8%) in the postnotification arm (difference of -1.6%; 95% CI of difference: -8.9%, 5.7%). There was no difference in time to response (HR = 1.04; 95% CI: 0.80 to 1.34) or need for additional reminders (OR = 0.71; 95% CI: 0.43 to 1.17). Meta-analysis of two RCTs showed no difference in response rates between prenotification and postnotification reminders (OR = 0.78 95% CI: 0.42 to 1.45)., Conclusion: Timing of SMS reminders did not improve response rates and time to response or affect the need for additional reminders., (Copyright © 2020 Elsevier Inc. All rights reserved.)

Aims: The aim of this study was to explore whether time to surgery affects functional outcome in displaced proximal humeral fractures., Methods: A total of 250 patients presenting within three weeks of sustaining a displaced proximal humeral fracture involving the surgical neck were recruited at 32 acute NHS hospitals in the United Kingdom between September 2008 and April 2011. Of the 125 participants, 109 received surgery (fracture fixation or humeral head replacement) as per randomization. Data were included for 101 and 67 participants at six-month and five-year follow-up, respectively. Oxford Shoulder Scores (OSS) collected at six, 12, and 24 months and at three, four, and five years following randomization was plotted against time to surgery. Long-term recovery was explored by plotting six-month scores against five-year scores and agreement was illustrated with a Bland-Altman plot., Results: The mean time from initial trauma to surgery was 10.5 days (1 to 33). Earlier surgical intervention did not improve OSS throughout follow-up, nor when stratified by participant age (< 65 years vs ≥ 65 years) and fracture severity (one- and two-part vs three- and four-part fractures). Participants managed later than reported international averages (three days in the United States and Germany, eight days in the United Kingdom) did not have worse outcomes. At five-year follow-up, 50 participants (76%) had the same or improved OSS compared with six months (six-month mean OSS 35.8 (SD 10.0); five-year mean OSS 40.1 (SD 9.1); r = 0.613). A Bland-Altman plot demonstrated a positive mean difference (3.3 OSS points (SD 7.92)) with wide 95% limits of agreement (-12.2 and 18.8 points)., Conclusion: Timing of surgery did not affect OSS at any stage of follow-up, irrespective of age or fracture type. Most participants had maximum functional outcome at six months that was maintained at five years. These findings may help guide providers of trauma services on surgical prioritization. Cite this article: Bone Joint J 2020;102-B(1):33-41.

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.

Objectives: To investigate the effects, costs, and feasibility of providing on-site compared with remote meetings to set up hospital sites in a multicenter, surgical randomized controlled trial., Study Design and Setting: Hospitals were randomized to receive the initial trial setup meetings on-site (i.e., face-to-face) or remotely (i.e., via teleconference). Data were collected on site setup, recruitment, follow-up, and costs for the two methods. The hospital staff experience of trial setup was also surveyed., Results: Thirty-nine sites were randomized and 33 sites set up to recruit (19 on-site and 14 remote). For sites randomized to an on-site meeting compared with remote meeting respectively, the time from first contact to the first recruit was a median of 246 days (interquartile range [IQR] 196-346] vs. 212 days (IQR 154-266), mean recruitment was 10 participants (median 10, IQR 2-17) vs. 11 participants (median 6, IQR 5-23), and participant follow-up at 12 months was 81% vs. 82%. Sites allocated to an initial on-site visit cost on average £289.83 more to setup., Conclusion: Remote or on-site visits are feasible for the initial setup meetings with hospitals in a multicenter surgical trial. This embedded trial should be replicated to improve generalizability and increase statistical power using meta-analysis. ISRCTN78899574., (Copyright © 2018 Elsevier Inc. All rights reserved.)

Background: Frozen shoulder (also known as adhesive capsulitis) occurs when the capsule, or the soft tissue envelope around the ball and socket shoulder joint, becomes scarred and contracted, making the shoulder tight, painful and stiff. It affects around 1 in 12 men and 1 in 10 women of working age. Although this condition can settle with time (typically taking 1 to 3 years), for some people it causes severe symptoms and needs referral to hospital. Our aim is to evaluate the clinical and cost-effectiveness of two invasive and costly surgical interventions that are commonly used in secondary care in the National Health Service (NHS) compared with a non-surgical comparator of Early Structured Physiotherapy., Methods: We will conduct a randomised controlled trial (RCT) of 500 adult patients with a clinical diagnosis of frozen shoulder, and who have radiographs that exclude other pathology. Early Structured Physiotherapy with an intra-articular steroid injection will be compared with manipulation under anaesthesia with a steroid injection or arthroscopic (keyhole) capsular release followed by manipulation. Both surgical interventions will be followed with a programme of post-procedural physiotherapy. These treatments will be undertaken in NHS hospitals across the United Kingdom. The primary outcome and endpoint will be the Oxford Shoulder Score (a patient self-reported assessment of shoulder function) at 12 months. This will also be measured at baseline, 3 and 6 months after randomisation; and on the day that treatment starts and 6 months later. Secondary outcomes include the Disabilities of Arm Shoulder and Hand (QuickDASH) score, the EQ-5D-5 L score, pain, extent of recovery and complications. We will explore the acceptability of the different treatments to patients and health care professionals using qualitative methods., Discussion: The three treatments being compared are the most frequently used in secondary care in the NHS, but there is uncertainty about which one works best and at what cost. UK FROST is a rigorously designed and adequately powered study to inform clinical decisions for the treatment of this common condition in adults., Trial Registration: International Standard Randomised Controlled Trial Register, ID: ISRCTN48804508 . Registered on 25 July 2014.

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., Competing Interests: Conflicts of Interest Statement: Professor Amar Rangan reports grants from De Puy Ltd and JRI Ltd; both are outside the submitted work. None of these influenced the trial or this report., (© 2017 Jefferson et al.)

Background: A scaphoid fracture is the most common type of carpal fracture affecting young active people. The optimal management of this fracture is uncertain. When treated with a cast, 88 to 90 % of these fractures unite; however, for the remaining 10-12 % the non-union almost invariably leads to arthritis. The alternative is surgery to fix the scaphoid with a screw at the outset., Methods/design: We will conduct a randomised controlled trial (RCT) of 438 adult patients with a "clear" and "bicortical" scaphoid waist fracture on plain radiographs to evaluate the clinical effectiveness and cost-effectiveness of plaster cast treatment (with fixation of those that fail to unite) versus early surgical fixation. The plaster cast treatment will be immobilisation in a below elbow cast for 6 to 10 weeks followed by mobilisation. If non-union is confirmed on plain radiographs and/or Computerised Tomogram at 6 to 12 weeks, then urgent surgical fixation will be performed. This is being compared with immediate surgical fixation with surgeons using their preferred technique and implant. These treatments will be undertaken in trauma units across the United Kingdom. The primary outcome and end-point will be the Patient Rated Wrist Evaluation (a patient self-reported assessment of wrist pain and function) at 52 weeks and also measured at 6, 12, 26 weeks and 5 years. Secondary outcomes include an assessment of radiological union of the fracture; quality of life; recovery of wrist range and strength; and complications. We will also qualitatively investigate patient experiences of their treatment., Discussion: Scaphoid fractures are an important public health problem as they predominantly affect young active individuals in the more productive working years of their lives. Non-union, if untreated, can lead to arthritis which can disable patients at a very young age. There is a rapidly increasing trend for immediate surgical fixation of these fractures but there is insufficient evidence from existing RCTs to support this. The SWIFFT Trial is a rigorously designed and adequately powered study which aims to contribute to the evidence-base to inform clinical decisions for the treatment of this common fracture in adults., Trial Registration: The trial is registered with the International Standard Randomised Controlled Trial Register ( ISRCTN67901257 ). Date registration assigned was 13/02/2013.

Objective: "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., Methods: Members of the United Kingdom Trial Managers' Network were surveyed in June 2013 to investigate their experiences in the design and conduct of Away Days in RCTs. We used data from a multicenter pragmatic surgical trial to explore the effects of an Away Day on the screening and recruitment of patients., Results: A total of 94 people responded to the survey. The majority (78%), who confirmed had organized an Away Day previously, found them to be useful. This is despite their costs. There was no evidence, however, from the analysis of data from a surgical trial that attendance at an Away Day increased the number of patients screened or recruited at participating sites., Conclusions: Although those responsible for managing RCTs in the UK tend to believe that trial Away Days are beneficial, evidence from a multicenter surgical trial shows no improvement on a key indicator of trial success. This points to the need to carefully consider the aims, design, and conduct of Away Days. Further more rigorous research nested within RCTs would be valuable to evaluate the design and conduct of Away Days., (© 2016 Chinese Cochrane Center, West China Hospital of Sichuan University and John Wiley & Sons Australia, Ltd.)

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., (©2016 The British Editorial Society of Bone & Joint Surgery.)

Importance: The need for surgery for the majority of patients with displaced proximal humeral fractures is unclear, but its use is increasing., Objective: To evaluate the clinical effectiveness of surgical vs nonsurgical treatment for adults with displaced fractures of the proximal humerus involving the surgical neck., Design, Setting, and Participants: A pragmatic, multicenter, parallel-group, randomized clinical trial, the Proximal Fracture of the Humerus Evaluation by Randomization (PROFHER) trial, recruited 250 patients aged 16 years or older (mean age, 66 years [range, 24-92 years]; 192 [77%] were female; and 249 [99.6%] were white) who presented at the orthopedic departments of 32 acute UK National Health Service hospitals between September 2008 and April 2011 within 3 weeks after sustaining a displaced fracture of the proximal humerus involving the surgical neck. Patients were followed up for 2 years (up to April 2013) and 215 had complete follow-up data. The data for 231 patients (114 in surgical group and 117 in nonsurgical group) were included in the primary analysis., Interventions: Fracture fixation or humeral head replacement were performed by surgeons experienced in these techniques. Nonsurgical treatment was sling immobilization. Standardized outpatient and community-based rehabilitation was provided to both groups., Main Outcomes and Measures: Primary outcome was the Oxford Shoulder Score (range, 0-48; higher scores indicate better outcomes) assessed during a 2-year period, with assessment and data collection at 6, 12, and 24 months. Sample size was based on a minimal clinically important difference of 5 points for the Oxford Shoulder Score. Secondary outcomes were the Short-Form 12 (SF-12), complications, subsequent therapy, and mortality., Results: There was no significant mean treatment group difference in the Oxford Shoulder Score averaged over 2 years (39.07 points for the surgical group vs 38.32 points for the nonsurgical group; difference of 0.75 points [95% CI, -1.33 to 2.84 points]; P = .48) or at individual time points. There were also no significant between-group differences over 2 years in the mean SF-12 physical component score (surgical group: 1.77 points higher [95% CI, -0.84 to 4.39 points]; P = .18); the mean SF-12 mental component score (surgical group: 1.28 points lower [95% CI, -3.80 to 1.23 points]; P = .32); complications related to surgery or shoulder fracture (30 patients in surgical group vs 23 patients in nonsurgical group; P = .28), requiring secondary surgery to the shoulder (11 patients in both groups), and increased or new shoulder-related therapy (7 patients vs 4 patients, respectively; P = .58); and mortality (9 patients vs 5 patients; P = .27). Ten medical complications (2 cardiovascular events, 2 respiratory events, 2 gastrointestinal events, and 4 others) occurred in the surgical group during the postoperative hospital stay., Conclusions and Relevance: Among patients with displaced proximal humeral fractures involving the surgical neck, there was no significant difference between surgical treatment compared with nonsurgical treatment in patient-reported clinical outcomes over 2 years following fracture occurrence. These results do not support the trend of increased surgery for patients with displaced fractures of the proximal humerus., Trial Registration: isrctn.com Identifier: ISRCTN50850043.

Background: Proximal humeral fractures account for 5-6% of all fractures in adults. There is considerable variation in whether or not surgery is used in the management of displaced fractures involving the surgical neck., Objective: To evaluate the clinical effectiveness and cost-effectiveness of surgical compared with non-surgical treatment of the majority of displaced fractures of the proximal humerus involving the surgical neck in adults., Design: A pragmatic parallel-group multicentre randomised controlled trial with an economic evaluation. Follow-up was for 2 years., Setting: Recruitment was undertaken in the orthopaedic departments of 33 acute NHS hospitals in the UK. Patient care pathways included outpatient and community-based rehabilitation., Participants: Adults (aged ≥ 16 years) presenting within 3 weeks of their injury with a displaced fracture of the proximal humerus involving the surgical neck., Interventions: The choice of surgical intervention was left to the treating surgeons, who used techniques with which they were experienced. Non-surgical treatment was initial sling immobilisation followed by active rehabilitation. Provision of rehabilitation was comparable in both groups., Main Outcome Measures: The primary outcome was the Oxford Shoulder Score (OSS) assessed at 6, 12 and 24 months. Secondary outcomes were the 12-item Short Form health survey, surgical and other shoulder fracture-related complications, secondary surgery to the shoulder or increased/new shoulder-related therapy, medical complications during inpatient stay and mortality. European Quality of Life-5 Dimensions data and treatment costs were also collected., Results: The mean age of the 250 trial participants was 66 years and 192 (77%) were female. Independent assessment using the Neer classification identified 18 one-part fractures, 128 two-part fractures and 104 three- or four-part fractures. OSS data were available for 215 participants at 2 years. We found no statistically or clinically significant differences in OSS scores between the two treatment groups (scale 0-48, with a higher score indicating a better outcome) over the 2-year period [difference of 0.75 points in favour of the surgery group, 95% confidence interval (CI) -1.33 to 2.84; p = 0.479; data from 114 surgery and 117 non-surgery participants] or at individual time points. We found no statistically significant differences between surgical and non-surgical group participants in SF-12 physical or mental component summary scores; surgical or shoulder fracture-related complications (30 vs. 23 respectively); those undergoing further shoulder-related therapy, either surgery (11 vs. 11 respectively) or other therapy (seven vs. four respectively); or mortality (nine vs. five respectively). The base-case economic analysis showed that, at 2 years, the cost of surgical intervention was, on average, £1780.73 more per patient (95% CI £1152.71 to £2408.75) than the cost of non-surgical intervention. It was also slightly less beneficial in terms of utilities, although this difference was not statistically significant. The net monetary benefit associated with surgery is negative. There was only a 5% probability of surgery achieving the criterion of costing < £20,000 to gain a quality-adjusted life-year, which was confirmed by extensive sensitivity analyses., Conclusions: Current surgical practice does not result in a better outcome for most patients with displaced fractures of the proximal humerus involving the surgical neck and is not cost-effective in the UK setting. Two areas for future work are the setting up of a national database of these fractures, including the collection of patient-reported outcomes, and research on the best ways of informing patients with these and other upper limb fractures about initial self-care., Trial Registration: Current Controlled Trials ISRCTN50850043., Funding: This project was funded by the NIHR Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 19, No. 24. See the NIHR Journals Library website for further project information.

Background: New evidence on the clinical effectiveness of acupuncture plus usual care (acupuncture) and counselling plus usual care (counselling) for patients with depression suggests the need to investigate the health-related quality of life and costs of these treatments to understand whether they should be considered a good use of limited health resources., Methods and Findings: The cost-effectiveness analyses are based on the Acupuncture, Counselling or Usual care for Depression (ACUDep) trial results. Statistical analyses demonstrate a difference in mean quality adjusted life years (QALYs) and suggest differences in mean costs which are mainly due to the price of the interventions. Probabilistic sensitivity analysis is used to express decision uncertainty. Acupuncture and counselling are found to have higher mean QALYs and costs than usual care. In the base case analysis acupuncture has an incremental cost-effectiveness ratio (ICER) of £4,560 per additional QALY and is cost-effective with a probability of 0.62 at a cost-effectiveness threshold of £20,000 per QALY. Counselling compared with acupuncture is more effective and more costly with an ICER of £71,757 and a probability of being cost-effective of 0.36. A scenario analysis of counselling versus usual care, excluding acupuncture as a comparator, results in an ICER of £7,935 and a probability of 0.91., Conclusions: Acupuncture is cost-effective compared with counselling or usual care alone, although the ranking of counselling and acupuncture depends on the relative cost of delivering these interventions. For patients in whom acupuncture is unavailable or perhaps inappropriate, counselling has an ICER less than most cost-effectiveness thresholds. However, further research is needed to determine the most cost-effective treatment pathways for depressed patients when the full range of available interventions is considered.

Purpose: In our study we explored the need to define a core outcome set for primary frozen shoulder., Methods: We investigated the outcomes used by studies included in a systematic review of the management of primary frozen shoulder; surveyed which primary outcome measures health care professionals considered important; and re-examined papers previously obtained for a systematic review of patients' views of interventions for frozen shoulder to investigate their views on outcomes., Results: Thirty-one studies investigated the outcomes range of movement (28 studies), pain (22), function and disability (22), adverse events (13), quality of life (7) and other outcomes (5). Many different types of pain and ranges of movement were measured. Function and disability was measured using fifteen instruments, the content of which varied considerably. Function and disability, pain and range of movement (132, 108 and 104 respondents, respectively) were most often cited by health care professionals as the primary outcome measure that should be used. Searches identified one paper that included patients' views. Outcomes of importance to patients were pain at night, general pain, reduced mobility (resulting in modification of activities) and the emotional impact of frozen shoulder., Conclusions: We identified a diverse range of outcomes that have been used or are considered to be important. The development of a core outcome set would improve the design and reporting of studies and availability of data for evidence synthesis. Methods used to develop a core outcome set should be robust, transparent and reflect the views of all stakeholders.

Objectives: To assess the responsiveness of the KQoL-26 and demonstrate minimal change for this instrument in two different samples of patients with suspected internal derangement of the knee., Methods: Data were collected from two surveys conducted alongside a clinical trial: the arthroscopy sample and the general practitioner (GP) sample. The effect size (ES) was used to assess responsiveness. Anchor-based minimal change included minimal clinical important difference (MCID) and receiver operator characteristic curves; standardized error of measurement and minimal detectable change (MDC) was employed for distribution-based approaches. The KQoL-26 results are compared with those for the Lysholm Knee Score, EQ-5D and SF-36., Results: The arthroscopy sample consisted of 121 participants and the GP sample of 218 participants at baseline. The largest ES was found for the KQoL-26 emotional functioning scale in both samples. The results were in favour of the condition-specific instrument. The MCID for KQoL-26 physical functioning, activities limitations and emotional functioning scales were 3, 15 and 18, respectively, in the arthroscopy sample; they were 11, 16 and 24 in the GP sample. The MDC 95 % was estimated as 18, 28 and 34, and 15, 24 and 30 in each sample, respectively., Conclusions: The KQoL-26 emotional functional scale was the most responsive of all scales. It is recommended that an instrument such as the KQoL-26 that includes emotional functioning should be included rather than the Lysholm in future clinical trials of patients with suspected internal derangement of the knee.

Purpose: To assess agreement between trained radiographers and consultant radiologists compared with an index radiologist when reporting on magnetic resonance imaging (MRI) examinations of the knee and lumbar spine and to examine the subsequent effect of discordant reports on patient management and outcome., Methods: At York Hospital two MR radiographers, two consultant radiologists and an index radiologist reported on a prospective, random sample of 326 MRI examinations. The radiographers reported in clinical practice conditions and the radiologists during clinical practice. An independent consultant radiologist compared these reports with the index radiologist report for agreement. Orthopaedic surgeons then assessed whether the discordance between reports was clinically important., Results: Overall observer agreement with the index radiologist was comparable between observers and ranged from 54% to 58%; for the knee it was 46-57% and for the lumbar spine was 56-66%. There was a very small observed difference of 0.6% (95% CI -11.9 to 13.0) in mean agreement between the radiographers and radiologists (P=0.860). For the knee, lumbar spine and overall, radiographers' discordant reports, when compared with the index radiologist, were less likely to have a clinically important effect on patient outcome than the radiologists' discordant reports. Less than 10% of observer's reports were sufficiently discordant with the index radiologist's reports to be clinically important., Conclusion: Carefully selected MR radiographers with postgraduate education and training reported in clinical practice conditions on specific MRI examinations of the knee and lumbar spine to a level of agreement comparable with non-musculoskeletal consultant radiologists., (Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.)

Computed tomography colonography (CTC) is the primary radiological test for the detection of colorectal tumours and precancerous polyps. Radiographer reporting of CTC examinations could help to improve the provision of this expanding service. We undertook a systematic review to assess the accuracy with which radiographers can provide formal written reports on intraluminal disease entities of CTC examinations compared to a reference standard. Data sources searched included online databases, peer-reviewed journals, grey literature, and reference and citation tracking. Eligible studies were assessed for bias, and data were extracted on study characteristics. Pooled estimates of sensitivities and specificities and chi-square tests of heterogeneity were calculated. Eight studies were eligible for inclusion with some risk to bias. Pooled estimates from three studies showed per patient sensitivity and specificity of reporting radiographers was 76% (95% CI: 70-80%) and 74% (95% CI: (67-80%), respectively. From seven studies, per lesion sensitivity for the detection of lesions >5 and >10 mm was 68% (95% CI: 65-71%) and 75% (95% CI: 72-79%) respectively. Pooled sensitivity for detection of lesions >5 mm in studies for which radiographers reported 50 or less training cases was 57% (95% CI: 52-61%) and more than 50 cases was 78% (95% CI: 74-81%). The current evidence does not support radiographers in a role involving the single formal written reporting of CTC examinations. Radiographers' performance, however, did appear to improve significantly with the number read. Therefore, when provided with adequate training and experience, there may be a potential role for radiographers in the reporting of CTC examinations., (Copyright © 2012 The Royal College of Radiologists. Published by Elsevier Ltd. All rights reserved.)

Background: Depression is a significant cause of morbidity. Many patients have communicated an interest in non-pharmacological therapies to their general practitioners. Systematic reviews of acupuncture and counselling for depression in primary care have identified limited evidence. The aim of this study was to evaluate acupuncture versus usual care and counselling versus usual care for patients who continue to experience depression in primary care., Methods and Findings: In a randomised controlled trial, 755 patients with depression (Beck Depression Inventory BDI-II score ≥ 20) were recruited from 27 primary care practices in the North of England. Patients were randomised to one of three arms using a ratio of 2.2.1 to acupuncture (302), counselling (302), and usual care alone (151). The primary outcome was the difference in mean Patient Health Questionnaire (PHQ-9) scores at 3 months with secondary analyses over 12 months follow-up. Analysis was by intention-to-treat. PHQ-9 data were available for 614 patients at 3 months and 572 patients at 12 months. Patients attended a mean of ten sessions for acupuncture and nine sessions for counselling. Compared to usual care, there was a statistically significant reduction in mean PHQ-9 depression scores at 3 months for acupuncture (-2.46, 95% CI -3.72 to -1.21) and counselling (-1.73, 95% CI -3.00 to -0.45), and over 12 months for acupuncture (-1.55, 95% CI -2.41 to -0.70) and counselling (-1.50, 95% CI -2.43 to -0.58). Differences between acupuncture and counselling were not significant. In terms of limitations, the trial was not designed to separate out specific from non-specific effects. No serious treatment-related adverse events were reported., Conclusions: In this randomised controlled trial of acupuncture and counselling for patients presenting with depression, after having consulted their general practitioner in primary care, both interventions were associated with significantly reduced depression at 3 months when compared to usual care alone., Trial Registration: Controlled-Trials.com ISRCTN63787732 Please see later in the article for the Editors' Summary.

Objectives: The purpose of this study was to test for the effect of waiting time from general practitioner (GP) referral to MRI or to orthopaedic consultation on outcomes of patients with knee problems, and to test whether any characteristics of trial participants predicted waiting time to MRI or orthopaedics., Methods: We undertook secondary analyses of data on 553 participants from a randomised trial who were recruited from 163 general practices during November 2002 to October 2004., Results: Of the patients allocated to MRI, 263 (94%) had an MRI, and of those referred to orthopaedics, 236 (86%) had an orthopaedic consultation. The median (interquartile range) waiting time in days from randomisation to MRI was 41.0 (21.0-71.0) and to orthopaedic appointment was 78.5 (54.5-167.5). Waiting time was found to have no significant effect on patient outcome for both the Short Form 36-item (SF-36) physical functioning score (p=0.570) and the Knee Quality of Life 26-item (KQoL-26) physical functioning score (p=0.268). There was weak evidence that males waited less time for their MRI (p=0.049) and older patients waited longer for their orthopaedic referral (p=0.049). For patients who resided in the catchment areas of some centres there were significantly longer waiting times for both MRI and orthopaedic appointment., Conclusion: Where patients reside is a strong predictor of waiting time for access to services such as MRI or orthopaedics. There is no evidence to suggest, however, that this has a significant effect on physical well-being in the short term for patients with knee problems.

Randomized controlled trials (RCTs) are considered the most robust design for evaluating health care interventions. However, it is difficult to acquire funding for RCTs, and they are complex to set up. Threats to their successful conduct and impact on clinical practice, particularly in surgical trials, include problems with recruitment, notably in terms of clinical equipoise and patient acceptability. Historically, RCTs are less common in surgical specialties, and their contribution to the orthopaedic literature remains small. Orthopaedic networks, such as orthopaedic associations, specialist societies, travel fellowships, and clinical research networks, provide an opportunity to meet the challenges of promoting RCTs in orthopaedic clinical practice. This can include identifying important research questions to help prioritize funding; educating and training surgeons in the design and practice of RCTs; helping to promote and coordinate RCTs; and disseminating the findings of RCTs. Orthopaedic trial networks should be encouraged to promote a research culture in which RCTs are feasible and to ensure that scarce resources utilized to support their funding are used most efficiently and to best effect. In particular, the use of networks is encouraged to support the conduct of RCTs in achieving patient recruitment, which is crucial in providing the evidence base to inform orthopaedic practice. Furthermore, to improve generalizability, acceptance of study findings and communication between orthopaedic surgeons, as well as international collaboration in trials, should be part of the strategy for the future.

Objective: To systematically review the effectiveness of behavioural therapy in depressed older adults., Methods: Electronic databases were searched to July 2009. Reference lists of systematic reviews and identified studies from the search strategy were also screened. Randomised controlled trials (RCTs) of behavioural therapy compared with waiting list controls or other psychotherapies in older adults (aged ≥55 years) with clinical depression were included. One author independently identified studies for inclusion. Two authors extracted data and assessed the included studies for risk of bias. Estimates of depression were combined using a random effects model and the I(2) statistic to examine heterogeneity., Results: Four RCTs were included in the meta-analysis. For post-treatment self-rated depression symptoms, behavioural therapy was not significantly more effective than a waiting list control [standardised mean difference (SMD) of -0.52, 95% confidence interval (CI) -1.35 to 0.30, p = 0.21, n = 117], cognitive therapy (SMD of 0.23, 95% CI -0.24 to 0.70, p = 0.33, n = 134) or brief psychodynamic therapy (SMD of -0.37, 95% CI -0.84 to 0.11, p = 0.13, n = 69). For post-treatment clinician-rated depression, behavioural therapy was not significantly more effective than cognitive therapy or brief psychodynamic therapy but was significantly more effective than a waiting list control (weighted mean difference (WMD) of -5.68, 95% CI -7.71 to -3.66, p < 0.001, n = 117)., Conclusions: Behavioural therapy in depressed older adults appears to have comparable effectiveness with alternative psychotherapies. Further research is recommended with the need for larger sample sizes, more clarity on trial design and the intervention, longer term follow-up and concomitant economic evaluations., (Copyright © 2011 John Wiley & Sons, Ltd.)

Background: Hundreds of thousands of volunteers take part in medical research, but many will never hear from researchers about what the study revealed. There is a growing demand for the results of randomised trials to be fed back to research participants both for ethical research practice and for ensuring their co-operation in a trial. This study aims to determine participants' preferences for type of leaflet (short versus long) used to summarise the findings of a randomised trial; and to test whether certain characteristics explained participants' preferences., Methods: 553 participants in a randomised trial about General Practitioners' access to Magnetic Resonance Imaging for patients presenting with suspected internal derangement of the knee were asked in the final follow-up questionnaire whether they would like to be fed back the results of the trial. Participants who agreed to this were included in a postal questionnaire survey asking about their preference, if any, between a short and a long leaflet and what it was about the leaflet that they preferred. Multinomial logistic regression was used to test whether certain demographics of responding participants along with treatment group explained whether a participant had a preference for type of leaflet or no preference., Results: Of the participants who returned the final follow-up questionnaire, 416 (88%) agreed to receive the results of the trial. Subsequently 132 (32%) participants responded to the survey. Most participants preferred the longer leaflet (55%) and the main reasons for this were the use of technical information (94%) and diagrams (89%). There was weak evidence to suggest that gender might explain whether participants have a preference for type of leaflet or not (P = 0.084)., Conclusions: Trial participants want to receive feed back about the results and appear to prefer a longer leaflet. Males and females might require information to be communicated to them differently and should be the focus of further research., Trial Registration: The trial is registered with http://www.isrctn.org/ and ID is ISRCTN76616358.

There are many types of treatment used to manage the frozen shoulder, but there is no consensus on how best to manage patients with this painful and debilitating condition. We conducted a review of the evidence of the effectiveness of interventions used to manage primary frozen shoulder using the Cochrane Database of Systematic Reviews, the Database of Abstracts of Reviews of Effects, the Physiotherapy Evidence Database, MEDLINE and EMBASE without language or date restrictions up to April 2009. Two authors independently applied selection criteria and assessed the quality of systematic reviews using the Assessment of Multiple Systematic Reviews (AMSTAR) tool. Data were synthesised narratively, with emphasis placed on assessing the quality of evidence. In total, 758 titles and abstracts were identified and screened, which resulted in the inclusion of 11 systematic reviews. Although these met most of the AMSTAR quality criteria, there was insufficient evidence to draw firm conclusions about the effectiveness of treatments commonly used to manage a frozen shoulder. This was mostly due to poor methodological quality and small sample size in primary studies included in the reviews. We found no reviews evaluating surgical interventions. More rigorous randomised trials are needed to evaluate the treatments used for frozen shoulder.

Abstract Objectives. To investigate which methods to identify post-natal depression are the most extensively validated, in what setting and in what language. Methods. A systematic search of the literature was undertaken to retrieve English and non-English language articles available until February 2007. This included searching 16 electronic databases, forward citation searching, personal communication with authors and inspection of reference lists. Results. A total of 60 studies (published in 64 articles) met the inclusion criteria. Four PND specific measures and nine generic depression (and sometimes anxiety) measures were found to have been validated against a diagnostic reference standard in pregnant or post-natal populations. The Edinburgh Post-natal Depression Scale (EPDS) was the most frequently validated method to identify women with PND. The EPDS has been translated and validated in 20 different languages. The majority of studies were undertaken at ante-natal clinics (n=15), after the birth in post-natal wards (n=12) or during post-natal visits or follow-up clinics (n=16). Conclusions. The EPDS is the most frequently researched method to identify PND and has been translated and validated in multiple different languages.

Background: Proximal humeral fractures, which occur mainly in older adults, account for approximately 4 to 5% of all fractures. Approximately 40% of these fractures are displaced fractures involving the surgical neck. Management of this group of fractures is often challenging and the outcome is frequently unsatisfactory. In particular it is not clear whether surgery gives better outcomes than non-surgical management. Currently there is much variation in the use of surgery and a lack of good quality evidence to inform this decision., Methods/design: We aim to undertake a pragmatic UK-based multi-centre randomised controlled trial evaluating the effectiveness and cost-effectiveness of surgical versus standard non-surgical treatment for adults with an acute closed displaced fracture of the proximal humerus with involvement of the surgical neck. The choice of surgical intervention is left to the surgeon, who must use techniques that they are fully experienced with. This will avoid 'learning curve' problems. We will promote good standards of non-surgical care, similarly insisting on care-provider competence, and emphasize the need for comparable provision of rehabilitation for both groups of patients.We aim to recruit 250 patients from a minimum of 18 NHS trauma centres throughout the UK. These patients will be followed-up for 2 years. The primary outcome is the Oxford Shoulder Score, which will be collected via questionnaires completed by the trial participants at 6, 12 and 24 months. This is a 12-item condition-specific questionnaire providing a total score based on the person's subjective assessment of pain and activities of daily living impairment. We will also collect data for other outcomes, including general health measures and complications, and for an economic evaluation. Additionally, we plan a systematic collection of reasons for non-inclusion of eligible patients who were not recruited into the trial, and their baseline characteristics, treatment preferences and intended treatment., Discussion: This article presents the protocol for a multi-centre randomised controlled trial. It gives extensive details of, and the basis for, the chosen methods, and describes the key measures taken to avoid bias and to ensure validity., Trial Registration: Current Controlled Trials ISRCTN50850043.

Background: There is some evidence that acupuncture for pain and osteoarthritis (OA) of the knee is more than a placebo, and short term clinical benefits have been observed when acupuncture is compared to usual care. However there is insufficient evidence on whether clinical benefits of acupuncture are sustained over the longer term. In this study our key objectives are to inform the design parameters for a fully powered pragmatic randomised controlled trial. These objectives include establishing potential recruitment rates, appropriate validated outcome measures, attendance levels for acupuncture treatment, loss to follow up and the sample size for a full scale trial., Methods: Potential participants aged over 50 with pain and osteoarthritis of the knee were identified from a GP database. Eligible patients were randomised to either 'acupuncture plus usual care' and 'usual care' alone, with allocation appropriately concealed. Acupuncture consisted of up to 10 sessions usually weekly. Outcome measures included Western Ontario and McMaster Universities (WOMAC) index with the sample size for a full scale trial determined from the variance., Results: From the GP database of 15,927 patients, 335 potential trial participants were identified and invited to participate. After screening responses, 78 (23%) were identified as eligible and 30 patients who responded most promptly were randomised to 'acupuncture plus usual care' (15 patients) and 'usual care' alone (15 patients). Attendance for acupuncture appointments was high at 90% of the maximum. Although the trial was not powered to detect significant changes in outcome, the WOMAC pain index showed a statistically significant reduction at 3 months in the acupuncture group compared to usual care. This was not sustained at 12 months. The sample size for a fully powered two-arm trial was estimated to be 350., Conclusion: This pilot study provided the evidence that a fully powered study to explore the longer term impact of acupuncture would be worthwhile, and relevant design features for such a trial were determined., Trial Registration Number: ISRCTN25134802.

Studies of diagnostic accuracy often report paired tests for sensitivity and specificity that can be pooled separately to produce summary estimates in a meta-analysis. This was done recently for a systematic review of radiographers' reporting accuracy of plain radiographs. The problem with pooling sensitivities and specificities separately is that it does not acknowledge any possible (negative) correlation between these two measures. A possible cause of this negative correlation is that different thresholds are used in studies to define abnormal and normal radiographs because of implicit variations in thresholds that occur when radiographers' report plain radiographs. A method that allows for the correlation that can exist between pairs of sensitivity and specificity within a study using a random effects approach is the bivariate model. When estimates of accuracy as a fixed-effects model were pooled separately, radiographers' reported plain radiographs in clinical practice at 93% (95% confidence interval (CI) 92-93%) sensitivity and 98% (95% CI 98-98%) specificity. The bivariate model produced the same summary estimates of sensitivity and specificity but with wider confidence intervals (93% (95% CI 91-95%) and 98% (95% CI 96-98%), respectively) that take into account the heterogeneity beyond chance between studies. This method also allowed us to calculate a 95% confidence ellipse around the mean values of sensitivity and specificity and a 95% prediction ellipse for individual values of sensitivity and specificity. The bivariate model is an improvement on pooling sensitivity and specificity separately when there is a threshold effect, and it is the preferred method of choice.