Physiotherapy for primary frozen shoulder in secondary care: Developing and implementing stand-alone and post operative protocols for UK FROST and inferences for wider practice.

OBJECTIVES: The United Kingdom Frozen Shoulder Trial (UK FROST) compares stand-alone physiotherapy and two operative procedures, both with post operative rehabilitation, for primary frozen shoulder in secondary care. We developed physiotherapy protocols for UK FROST, incorporating best evidence but recognizing uncertainty and allowing flexibility. METHODS: We screened a UK Department of Health systematic review and UK evidence-based guidelines (Hanchard et al., 2012; Maund et al., 2012) for recommendations, and previous surveys of UK physiotherapists (Hanchard et al., 2011, 2013) for strong consensus. We conducted a two-stage, questionnaire-based, modified Delphi survey of shoulder specialist physiotherapists in the UK National Health Service. This required positive, negative or neutral ratings of possible interventions in four clinical contexts (stand-alone physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder; and post operative physiotherapy for, respectively, predominantly painful and predominantly stiff frozen shoulder). We proposed respectively mandating or recommending interventions with 100% and 90% positive consensus, and respectively disallowing or discouraging interventions with 90% and 80% negative consensus. Other interventions would be optional. RESULTS: The systematic review and guideline recommended including steroid injection and manual mobilizations in non-operative care, and we mandated these for stand-alone physiotherapy. Consensus in the pre-existing surveys strongly favoured advice, education and home exercises, which we mandated across contexts. The Delphi survey led to recommendation of some supervised exercise modalities, plus the disallowing or discouragement-in various contexts-of immobilization and some 'higher-tech' electrotherapies and alternative therapies. CONCLUSIONS: We developed physiotherapy protocols despite incomplete empirical evidence. Their clear structure enabled implementation in data-sheets designed to facilitate recording, monitoring of fidelity and reporting of interventions. Other trials involving physiotherapy may benefit from this approach.

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

AIMS: The PROximal Fracture of the Humerus Evaluation by Randomisation (PROFHER) randomised clinical trial compared the operative and non-operative treatment of adults with a displaced fracture of the proximal humerus involving the surgical neck. The aim of this study was to determine the long-term treatment effects beyond the two-year follow-up. PATIENTS AND METHODS: Of the original 250 trial participants, 176 consented to extended follow-up and were sent postal questionnaires at three, four and five years after recruitment to the trial. The Oxford Shoulder Score (OSS; the primary outcome), EuroQol 5D-3L (EQ-5D-3L), and any recent shoulder operations and fracture data were collected. Statistical and economic analyses, consistent with those of the main trial were applied. RESULTS: OSS data were available for 164, 155 and 149 participants at three, four and five years, respectively. There were no statistically or clinically significant differences between operative and non-operative treatment at each follow-up point. No participant had secondary shoulder surgery for a new complication. Analyses of EQ-5D-3L data showed no significant between-group differences in quality of life over time. CONCLUSION: These results confirm that the main findings of the PROFHER trial over two years are unchanged at five years. Cite this article: Bone Joint J 2017;99-B:383-92.

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

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

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

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

Evidence of reference standard related bias in studies of plain radiograph reading performance: a meta-regression.

The aim is to determine the effect of reference standard related bias on estimates of plain radiograph reading performance using studies conducted in clinical practice. Data were extracted on study eligibility, clinical and reference standard characteristics and reading performance. The choice of reference standards and the prevalence of bias are presented descriptively. Associations between bias and reading performance are estimated using a regression model that produces relative diagnostic odds ratios (RDOR) with 95% confidence intervals (CIs). Three of the 20 eligible studies addressed all five reference standard related biases; 15 studies addressed three or more. When the reference standard report is influenced by knowledge of an observer's opinion this is associated with a significant overestimation in reading performance (RDOR, 3.7; 95% CI, 1.6 to 8.3; p = 0.01). There is limited evidence that reading performance is inflated when the observer is aware of the reference standard report before commenting on the radiograph (RDOR, 1.7; 95% CI, 0.6 to 5.1) and deflated when a less valid reference standard is used (RDOR, 0.5; 95% CI, 0.1 to 2.5). There is no evidence that reading performance is affected by application of the reference standard depending on an observer's opinion and using different reference standards in the same study. In conclusion we found variation in the choice and application of reference standards in studies of plain radiograph reading performance, but only when reference standards report in the knowledge of an observer's opinion does this contribute to a significant overestimation in reading performance.

Radiographers and radiologists reporting plain radiograph requests from accident and emergency and general practice.

AIM: To assess selectively trained radiographers and consultant radiologists reporting plain radiographs for the Accident and Emergency Department (A&E) and general practitioners (GPs) within a typical hospital setting. METHODS: Two radiographers, a group of eight consultant radiologists, and a reference standard radiologist independently reported under controlled conditions a retrospectively selected, random, stratified sample of 400 A&E and 400 GP plain radiographs. An independent consultant radiologist judged whether the radiographer and radiologist reports agreed with the reference standard report. Clinicians then assessed whether radiographer and radiologist incorrect reports affected confidence in their diagnosis and treatment plans, and patient outcome. RESULTS: For A&E and GP plain radiographs, respectively, there was a 1% (95% confidence interval (CI) -2 to 5) and 4% (95% CI -1 to 8) difference in reporting accuracy between the two professional groups. For both A&E and GP cases there was an 8% difference in the clinicians' confidence in their diagnosis based on radiographer or radiologist incorrect reports. For A&E and GP cases, respectively, there was a 2% and 8% difference in the clinicians' confidence in their management plans based on radiographer or radiologist incorrect reports. For A&E and GP cases, respectively, there was a 1% and 11% difference in effect on patient outcome of radiographer or radiologist incorrect reports. CONCLUSION: There is the potential to extend the reporting role of selectively trained radiographers to include plain radiographs for all A&E and GP patients. Further research conducted during clinical practice at a number of sites is recommended.

The effect of introducing radiographer reporting on the availability of reports for Accident and Emergency and General Practitioner examinations: a time-series analysis.

This study explores whether the introduction of selectively trained radiographers reporting Accident and Emergency (A&E) X-ray examinations of the appendicular skeleton affected the availability of reports for A&E and General Practitioner (GP) examinations at a typical district general hospital. This was achieved by analysing monthly data on A&E and GP examinations for 1993-1997 using structural time-series models. Parameters to capture stochastic seasonal effects and stochastic time trends were included in the models. The main outcome measures were changes in the number, proportion and timeliness of A&E and GP examinations reported. Radiographer reporting X-ray examinations requested by A&E was associated with a 12% (p=0.050) increase in the number of A&E examinations reported and a 37% (p