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Bone & Joint Open
Vol. 4, Issue 2 | Pages 96 - 103
14 Feb 2023
Knowlson CN Brealey S Keding A Torgerson D Rangan A

Aims

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.

Methods

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.


Bone & Joint Open
Vol. 3, Issue 9 | Pages 701 - 709
2 Sep 2022
Thompson H Brealey S Cook E Hadi S Khan SHM Rangan A

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.


Orthopaedic Proceedings
Vol. 103-B, Issue SUPP_13 | Pages 51 - 51
1 Nov 2021
Santhosh S Dias J Brealey S Leighton P
Full Access

Introduction and Objective

Scaphoid waist fractures (SWF) are notable in upper limb trauma and predominantly occur in young men. Morbidities associated with SWF include fracture non-union, premature arthritis and humpback deformity. Delayed treatment and non-adherence to fracture immobilisation increases likelihood of these complications. There is evidence that men engage in negative health behaviours such as delayed help-seeking. The Scaphoid Waist Internal Fixation for Fractures Trial (SWIFFT) conducted interviews in individuals who had sustained a SWF. Although SWIFFT showed multiple social determinants for the overall injury and healing experience, a key factor this novel study considers is age and sex. This study aimed to analyse interview data from young male participants in SWIFFT to help distinguish the experience of SWF in young men, through exploring the influence of masculinity.

Materials and Methods

A purposive sample of 12 young male participants were selected from SWIFFT. These participants were enrolled from a possibility of 13 different centres across Britain. There were 17 semi-structured interviews produced from these participants, and this was thought to be sufficient for data saturation. These interviews were evaluated through deductive thematic analysis with an open-coding approach, with respondents’ experiences being compared against themes documented in men's health literature. The “Braun and Clarke (2006) Six Phases of Thematic Analysis” methodology was adopted to perform this.


Bone & Joint Open
Vol. 2, Issue 9 | Pages 773 - 784
1 Sep 2021
Rex SS Kottam L McDaid C Brealey S Dias J Hewitt CE Keding A Lamb SE Wright K Rangan A

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.


Bone & Joint Open
Vol. 2, Issue 8 | Pages 685 - 695
2 Aug 2021
Corbacho B Brealey S Keding A Richardson G Torgerson D Hewitt C McDaid C Rangan A

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.


Bone & Joint Open
Vol. 2, Issue 3 | Pages 150 - 163
1 Mar 2021
Flett L Adamson J Barron E Brealey S Corbacho B Costa ML Gedney G Giotakis N Hewitt C Hugill-Jones J Hukins D Keding A McDaid C Mitchell A Northgraves M O'Carroll G Parker A Scantlebury A Stobbart L Torgerson D Turner E Welch C Sharma H

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.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 33 - 41
1 Jan 2020
Norman JG Brealey S Keding A Torgerson D Rangan A

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.


Bone & Joint Research
Vol. 6, Issue 10 | Pages 590 - 599
1 Oct 2017
Jefferson L Brealey S Handoll H Keding A Kottam L Sbizzera I Rangan A

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.


The Bone & Joint Journal
Vol. 98-B, Issue 2 | Pages 152 - 159
1 Feb 2016
Corbacho B Duarte A Keding A Handoll H Chuang LH Torgerson D Brealey S Jefferson L Hewitt C Rangan A

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 9 | Pages 1267 - 1272
1 Sep 2010
Rookmoneea M Dennis L Brealey S Rangan A White B McDaid C Harden M

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.


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 6 | Pages 772 - 775
1 Jun 2009
Wilson J Bonner TJ Head M Fordham J Brealey S Rangan A

Low-energy fractures of the proximal humerus indicate osteoporosis and it is important to direct treatment to this group of patients who are at high risk of further fracture. Data were prospectively collected from 79 patients (11 men, 68 women) with a mean age of 69 years (55 to 86) with fractures of the proximal humerus in order to determine if current guidelines on the measurement of the bone mineral density at the hip and lumbar spine were adequate to stratify the risk and to guide the treatment of osteoporosis. Bone mineral density measurements were made by dual-energy x-ray absorptiometry at the proximal femur, lumbar spine (L2-4) and contralateral distal radius, and the T-scores were generated for comparison. Data were also collected on the use of steroids, smoking, the use of alcohol, hand dominance and comorbidity.

The mean T-score for the distal radius was −2.97 (sd 1.56) compared with −1.61 (sd 1.62) for the lumbar spine and −1.78 (sd 1.33) for the femur. There was a significant difference between the mean lumbar and radial T scores (1.36 (1.03 to 1.68); p < 0.001) and between the mean femoral and radial T-scores (1.18 (0.92 to 1.44); p < 0.001). The inclusion of all three sites in the determination of the T-score increased the sensitivity to 66% compared with that of 46% when only the proximal femur and lumbar spine were used. This difference between measurements in the upper limb compared with the axial skeleton and lower limb suggests that basing risk assessment and treatment on only the bone mineral density taken at the hip or lumbar spine may misrepresent the extent of osteoporosis in the upper limb and the subsequent risk of fracture at this site.

The assessment of osteoporosis must include measurement of the bone mineral density at the distal radius to avoid underestimation of osteoporosis in the upper limb.


Orthopaedic Proceedings
Vol. 85-B, Issue SUPP_III | Pages 241 - 241
1 Mar 2003
Brealey S
Full Access

Background: Systematic reviews in back pain suggest beneficial effects from spinal manipulation, general exercise, and ‘active management’. These approaches have not been tested rigorously in the UK National Health Service. The UK BEAM trial was designed to evaluate such treatments for back pain in primary care. This paper describes the manipulation package used in the trial and the frequency with which the different elements of the package were delivered by therapists.

Methods/Results: At over 150 UK practices, patients consulting GPs with back pain were identified. Eligible and consenting patients were then randomised to receive one of GP active management, manipulation (either in NHS or private premises), exercise classes or both manipulation and exercise. Manipulation was delivered either by a chiropractor, an osteopath, or a physiotherapist. A package of manipulative care, agreed by the three professions, was developed, and practitioners could choose elements from the package within broad constraints.

The trial recruited 1334 participants, across 14 centres. Participants who received manipulation alone attended on average 6.5 sessions compared with 5.2 sessions when receiving manipulation combined with exercise. A ‘results embargo’ precludes detailed results prior to the conference, but we shall present findings about the pattern of delivery of the various elements of the manipulation package for these treatments, within NHS or private premises, and whether delivered by a chiropractor, an osteopath, or a physiotherapist.

Conclusion: Participants received more treatment sessions when randomised to manipulation alone compared with manipulation and exercise. This may be due to differences in the duration of treatment periods, which affected both clinician and patient availability. Findings will also show if there is variation in the delivery of manipulation depending on the treatment package, setting and profession. We shall use these data in the secondary analysis to determine the extent to which they explain variation in treatment effects.


Orthopaedic Proceedings
Vol. 84-B, Issue SUPP_III | Pages 327 - 327
1 Nov 2002
Brealey S
Full Access

Objective: The UK BEAM trial was designed to evaluate treatments for back pain in primary care. The objective is to briefly describe the different treatments and to present the frequency with which trial participants attended for manipulation, exercise or both.

Design: The UK BEAM trial is a national randomised factorial trial in primary care. Participants were randomised to receive one of GP management, exercise classes, manipulation (in either private or NHS premises) or both exercise classes and manipulation. Participants randomised to manipulation alone could receive up to eight sessions delivered by a chiropractor, an osteopath, or a physiotherapist. Those randomised to exercise alone could attend up to nine sessions led by a physiotherapist in a local community facility. Subsequently, those randomised to manipulation followed by exercise could attend up to 17 sessions.

Subjects: Participants were recruited from 150 GP practices in 14 centres distributed across the United Kingdom. The target population was patients between 18 and 65 years who present in general practice with non-specific back pain with or without leg pain.

Outcome Measures: The frequency that participants attended for manipulation, exercise, or both.

Results: The trial recruited 1334 participants. The current analysis shows the mean number of sessions attended by participants for manipulation alone is 6.6. The mean number of sessions attended for exercise alone is 4.4. In contrast, those participants randomised to manipulation followed by exercise attended 5.2 and 3.4 sessions respectively.

Conclusions: Those participants who were randomised to manipulation followed by exercise attended fewer sessions on average than those randomised to manipulation or exercise alone.