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Bone & Joint Open
Vol. 4, Issue 3 | Pages 188 - 197
15 Mar 2023
Pearson NA Tutton E Gwilym SE Joeris A Grant R Keene DJ Haywood KL

Aims. To systematically review qualitative studies of patients with distal tibia or ankle fracture, and explore their experience of injury and recovery. Methods. We undertook a systematic review of qualitative studies. Five databases were searched from inception to 1 February 2022. All titles and abstracts were screened, and a subset were independently assessed. Methodological quality was appraised using the Critical Appraisal Skills Programme (CASP) checklist. The GRADE-CERQual checklist was used to assign confidence ratings. Thematic synthesis was used to analyze data with the identification of codes which were drawn together to form subthemes and then themes. Results. From 2,682 records, 15 studies were reviewed in full and four included in the review. A total of 72 patients were included across the four studies (47 female; mean age 50 years (17 to 80)). Methodological quality was high for all studies, and the GRADE-CERQual checklist provided confidence that the findings were an adequate representation of patient experience of distal tibia or ankle fracture. A central concept of ‘being the same but different’ conveyed the substantial disruption to patients’ self-identity caused by their injury. Patient experience of ‘being the same but different’ was expressed through three interrelated themes, with seven subthemes: i) being proactive where persistence, doing things differently and keeping busy prevailed; ii) living with change including symptoms, and living differently due to challenges at work and leisure; and iii) striving for normality, adapting while lacking in confidence, and feeling fearful and concerned about the future. Conclusion. Ankle injuries were disruptive, draining, and impacted on patients’ wellbeing. Substantial short- and longer-term challenges were experienced during recovery. Rehabilitation and psychosocial treatment strategies may help to ameliorate these challenges. Patients may benefit from clinicians being cognisant of patient experience when assessing, treating, and discussing expectations and outcomes with patients. Cite this article: Bone Jt Open 2023;4(3):188–197


The Bone & Joint Journal
Vol. 100-B, Issue 4 | Pages 522 - 526
1 Apr 2018
Tutton E Achten J Lamb SE Willett K Costa ML

Aims. The aim of this study was to explore the patients’ experience of recovery from open fracture of the lower limb in acute care. Patients and Methods. A purposeful sample of 20 participants with a mean age of 40 years (20 to 82) (16 males, four females) were interviewed a mean of 12 days (five to 35) after their first surgical intervention took place between July 2012 and July 2013 in two National Health Service (NHS) trusts in England, United Kingdom. The qualitative interviews drew on phenomenology and analysis identified codes, which were drawn together into categories and themes. Results. The findings identify the vulnerability of the patients expressed through three themes; being emotionally fragile, being injured and living with injury. The participants felt a closeness to death and continued uncertainty regarding loss of their limb. They experienced strong emotions while also trying to contain their emotions for the benefit of others. Their sense of self changed as they became a person with visible wounds, needed intimate help, and endured pain. When ready, they imagined what it would be like to live with injury. Conclusion. Recovery activities require an increased focus on emotional wellbeing. Surgeons are aware of the need for clinical expertise and for adequate pain relief but may not be as aware that their patients require support regarding their body image and help to imagine their future life. Cite this article: Bone Joint J 2018;100-B:522–6


Bone & Joint Open
Vol. 3, Issue 4 | Pages 321 - 331
8 Apr 2022
Dean BJF Srikesavan C Horton R Toye F

Aims. Osteoarthritis (OA) affecting the thumb carpometacarpal joint (CMCJ) is a common painful condition. In this study, we aimed to explore clinicians’ approach to management with a particular focus on the role of specific interventions that will inform the design of future clinical trials. Methods. We interviewed a purposive sample of 24 clinicians, consisting of 12 surgeons and 12 therapists (four occupational therapists and eight physiotherapists) who managed patients with CMCJ OA. This is a qualitative study using semi-structured, online interviews. Interviews were audio-recorded, transcribed verbatim, and analyzed using thematic analysis. Results. A total of 14 themes were developed, six of which were developed relating to the clinical management of CMCJ OA: 1) A flexible ‘ladder’ approach starting with conservative treatment first; 2) The malleable role of steroid injection; 3) Surgery as an invasive and risky last resort; 4) A shared and collaborative approach; 5) Treating the whole person; and 6) Severity of life impact influences treatment. The remaining eight themes were developed relating to clinical trial barriers and facilitators: 1) We need to embrace uncertainty; 2) You are not losing out by taking part; 3) It is difficult to be neutral about certain treatments; 4) Difficult to recruit to ‘no treatment’ ; 5) Difficult to recruit to a trial comparing no surgery to surgery; 6) Patients are keen to participate in research; 7) Burden on staff and participants; and 8) A enthusiasm for a variety of potential trial arms. Conclusion. Our findings contribute to a better understanding of how clinicians manage thumb CMCJ OA in their practice settings. Our study also provides useful insights informing the design of randomized clinical trials involving steroid injections and surgery in people with thumb CMCJ OA. Cite this article: Bone Jt Open 2022;3(4):321–331


Bone & Joint Open
Vol. 4, Issue 10 | Pages 735 - 741
2 Oct 2023
Galloway AM Pini S Holton C Perry DC Redmond A Siddle HJ Richards S

Aims. Perthes’ disease is an idiopathic avascular necrosis of the developing femoral head, often causing deformity that impairs physical function. Current treatments aim to optimize the joint reaction force across the hip by enhancing congruency between the acetabulum and femoral head. Despite a century of research, there is no consensus regarding the optimal treatment. The aim of this study was to describe the experiences of children, their families, and clinicians when considering the treatment of Perthes’ disease. Methods. A qualitative study gathered information from children and their families affected by Perthes’ disease, along with treating clinicians. Interviews followed a coding framework, with the interview schedule informed by behavioural theory and patient and public involvement. Transcripts were analyzed using the framework method. Results. A total of 24 interviews took place, with 12 child/family dyads and 12 clinicians from UK NHS centres. Interviews identified widespread variation of routine care. Children/their families recounted positive experiences when included in the decision-making process for treatment. There is a strong desire from clinicians and children/families for consistent guidance from everyone involved in care, which should be based on clinical consensus. Conclusion. This is the first study to describe how children/families and clinicians experienced receiving or providing treatment in Perthes’ disease. The results indicate the need for robust evidence to support treatment decisions. Children and families valued feeling involved in the clinical decision-making process. Clinicians acknowledged the central importance of providing patient-centred care, particularly in the absence of robust evidence to guide the optimal treatment decisions. This study will inform a future Delphi project to develop clinical consensus guidelines for the treatment of Perthes’ disease. Cite this article: Bone Jt Open 2023;4(10):735–741


Bone & Joint Open
Vol. 2, Issue 6 | Pages 359 - 364
1 Jun 2021
Papiez K Tutton E Phelps EE Baird J Costa ML Achten J Gibson P Perry DC

Aims. The aim of this study was to explore parents and young people’s experience of having a medial epicondyle fracture, and their thoughts about the uncertainty regarding the optimal treatment. Methods. Families were identified after being invited to participate in a randomized controlled trial of surgery or no surgery for displaced medial epicondyle fractures of the humerus in children. A purposeful sample of 25 parents (22 females) and five young people (three females, mean age 11 years (7 to 14)) from 15 UK hospitals were interviewed a mean of 39 days (14 to 78) from injury. Qualitative interviews were informed by phenomenology and themes identified to convey participants’ experience. Results. The results identify parents’ desire to do the best for their child expressed through two themes: 1) ‘uncertainty’ (being uncertain about the best treatment option); and 2) ‘facilitating recovery’ (sharing the experience). Parents and young people were shocked when confronted with uncertainty about treatment and they felt responsible for the decision. They searched for further information, drew on their own experience, and struggled to weigh up risks of the treatments. Discussion with surgeons provided crucial support for decision-making, and young people were involved to a varying degree. In facilitating recovery, parents balanced increasing activity with protecting their child, but lacked knowledge about pain management, and how to improve strength and function of the arm. They hoped for a return to normal, including competitive sports. Conclusion. Surgeons are aware of the impact of injury on children and their parents; however, they may be less aware of the turmoil created by treatment uncertainty. Confident surgeons who appreciate and contextualize the importance of pre-existing experience and beliefs are best placed to help the family develop confidence to embrace uncertainty, particularly regarding participation in clinical trials. Cite this article: Bone Jt Open 2021;2(6):359–364


Bone & Joint Open
Vol. 2, Issue 1 | Pages 9 - 15
1 Jan 2021
Dy CJ Brogan DM Rolf L Ray WZ Wolfe SW James AS

Aims. Brachial plexus injury (BPI) is an often devastating injury that affects patients physically and emotionally. The vast majority of the published literature is based on surgeon-graded assessment of motor outcomes, but the patient experience after BPI is not well understood. Our aim was to better understand overall life satisfaction after BPI, with the goal of identifying areas that can be addressed in future delivery of care. Methods. We conducted semi-structured interviews with 15 BPI patients after initial nerve reconstruction. The interview guide was focused on the patient’s experience after BPI, beginning with the injury itself and extending beyond surgical reconstruction. Inductive and deductive thematic analysis was used according to standard qualitative methodology to better understand overall life satisfaction after BPI, contributors to life satisfaction, and opportunities for improvement. Results. Among the 15 patients interviewed, the following themes emerged: 1) happiness and life satisfaction were noted despite limitations in physical function; 2) quality of social support influences life satisfaction during recovery from BPI; and 3) social participation and having a sense of purpose impact life satisfaction during recovery from BPI. Conclusion. How patients perceive their BPI treatment and recovery varies widely, and is not directly linked to their self-reported functional outcome. Patients with stronger social circles and activities that give them a sense of fulfillment were more likely to be satisfied with their current status. Evaluating a patient’s social network, goals, and potential supportive adaptations early in the treatment timeline through coordinated multidisciplinary care may improve overall satisfaction during recovery from BPI. Cite this article: Bone Joint Open 2020;2(1):9–15


Bone & Joint Open
Vol. 5, Issue 4 | Pages 324 - 334
19 Apr 2024
Phelps EE Tutton E Costa ML Achten J Gibson P Perry DC

Aims

The aim of this study was to explore clinicians’ experience of a paediatric randomized controlled trial (RCT) comparing surgical reduction with non-surgical casting for displaced distal radius fractures.

Methods

Overall, 22 staff from 15 hospitals who participated in the RCT took part in an interview. Interviews were informed by phenomenology and analyzed using thematic analysis.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 17 - 25
1 Jan 2020
Trickett RW Mudge E Price P Pallister I

Aims. The aim of this study was to develop a psychometrically sound measure of recovery for use in patients who have suffered an open tibial fracture. Methods. An initial pool of 109 items was generated from previous qualitative data relating to recovery following an open tibial fracture. These items were field tested in a cohort of patients recovering from an open tibial fracture. They were asked to comment on the content of the items and structure of the scale. Reduction in the number of items led to a refined scale tested in a larger cohort of patients. Principal components analysis permitted further reduction and the development of a definitive scale. Internal consistency, test-retest reliability, and responsiveness were assessed for the retained items. Results. The initial scale was completed by 35 patients who were recovering from an open tibial fracture. Subjective and objective analysis permitted removal of poorly performing items and the addition of items suggested by patients. The refined scale consisted of 50 Likert scaled items and eight additional items. It was completed on 228 occasions by a different cohort of 204 patients with an open tibial fracture recruited from several UK orthoplastic tertiary referral centres. There were eight underlying components with tangible real-life meaning, which were retained as sub-scales represented by ten Likert scaled and eight non-Likert items. Internal consistency and test-retest reliability were good to excellent. Conclusion. The Wales Lower Limb Trauma Recovery (WaLLTR) Scale is the first tool to be developed from patient data with the potential to assess recovery following an open tibial fracture. Cite this article: Bone Joint J 2020;102-B(1):17–25


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 781 - 785
1 Jul 2022
Ferraro SL Williams DN Millis MB

Aims

The aim of this study was to understand the experience of mature patients who undergo a periacetabular osteotomy (PAO), a major hip-preserving surgical procedure that treats symptomatic hip dysplasia by realigning the acetabulum. Our aim was to improve our understanding of how the operation affected the lives of patients and their families, with a long-term goal of improving their experience.

Methods

We used a phenomenological approach with in-depth, semi-structured interviews to investigate the experience of seven female patients, aged between 25 and 40 years, who underwent a PAO. A modified homogeneity sampling approach coupled with criterion sampling was used. Inclusion criteria involved having at least one child at home and being in a committed relationship with a spouse or partner.


The Bone & Joint Journal
Vol. 99-B, Issue 1 | Pages 66 - 72
1 Jan 2017
Sigmund IK Holinka J Gamper J Staats K Böhler C Kubista B Windhager R

Aims. The diagnosis of periprosthetic joint infection (PJI) remains demanding due to limitations of all the available diagnostic tests. The synovial fluid marker, α-defensin, is a promising adjunct for the assessment of potential PJI. The purpose of this study was to investigate the qualitative assessment of α-defensin, using Synovasure to detect or exclude periprosthetic infection in total joint arthroplasty. Patients and Methods. We studied 50 patients (28 women, 22 men, mean age 65 years; 20 to 89) with a clinical indication for revision arthroplasty who met the inclusion criteria of this prospective diagnostic study. The presence of α-defensin was determined using the qualitative Synovasure test and compared with standard diagnostic methods for PJI. Based on modified Musculoskeletal Infection Society (MSIS) criteria, 13 cases were categorised as septic and 36 as aseptic revisions. One test was inconclusive. Results. The Synovasure test achieved a sensitivity of 69% and a specificity of 94%. The positive and negative likelihood ratios were 12.46 and 0.33, respectively. A good diagnostic accuracy for PJI, with an area under the curve of 0.82, was demonstrated. Adjusted p-values using the method of Hochberg showed that Synovasure is as good at diagnosing PJI as histology (p = 0.0042) and bacteriology with one positive culture (p = 0.0327). Conclusion. With its ease of use and rapid results after approximately ten minutes, Synovasure may be a useful adjunct in the diagnosis of PJI. Cite this article: Bone Joint J 2017;99-B:66–72


Bone & Joint Open
Vol. 5, Issue 5 | Pages 426 - 434
21 May 2024
Phelps EE Tutton E Costa ML Achten J Gibson P Moscrop A Perry DC

Aims

The aim of this study was to explore parents’ experience of their child’s recovery, and their thoughts about their decision to enrol their child in a randomized controlled trial (RCT) of surgery versus non-surgical casting for a displaced distal radius fracture.

Methods

A total of 20 parents of children from 13 hospitals participating in the RCT took part in an interview five to 11 months after injury. Interviews were informed by phenomenology and analyzed using thematic analysis.


Bone & Joint Open
Vol. 5, Issue 7 | Pages 543 - 549
3 Jul 2024
Davies AR Sabharwal S Reilly P Sankey RA Griffiths D Archer S

Aims

Shoulder arthroplasty is effective in the management of end-stage glenohumeral joint arthritis. However, it is major surgery and patients must balance multiple factors when considering the procedure. An understanding of patients’ decision-making processes may facilitate greater support of those considering shoulder arthroplasty and inform the outcomes of future research.

Methods

Participants were recruited from waiting lists of three consultant upper limb surgeons across two NHS hospitals. Semi-structured interviews were conducted with 12 participants who were awaiting elective shoulder arthroplasty. Transcribed interviews were analyzed using a grounded theory approach. Systematic coding was performed; initial codes were categorized and further developed into summary narratives through a process of discussion and refinement. Data collection and analyses continued until thematic saturation was reached.


The Bone & Joint Journal
Vol. 102-B, Issue 6 | Pages 736 - 743
1 Jun 2020
Svensson K Rolfson O Mohaddes M Malchau H Erichsen Andersson A

Aims

To investigate the experience and emotional impact of prosthetic joint infection (PJI) on orthopaedic surgeons and identify holistic strategies to improve the management of PJI and protect surgeons’ wellbeing.

Methods

In total, 18 prosthetic joint surgeons in Sweden were recruited using a purposive sampling strategy. Content analysis was performed on transcripts of individual in-person interviews conducted between December 2017 and February 2018.


The Journal of Bone & Joint Surgery British Volume
Vol. 43-B, Issue 4 | Pages 791 - 799
1 Nov 1961
McPherson A Gordon LH Scales JT

1. A method of recording changes in bone blood-flow using a heated thermocouple is described.

2. Occlusion of the femoral artery or aorta decreases the blood-flow in the femoral metaphysis.

3. Occlusion of the femoral vein and intravenous injection of adrenaline, nor-adrenaline, acetylcholine, histamine or hexamethonium bromide increase the blood-flow in the femoral metaphysis.


Bone & Joint Research
Vol. 12, Issue 1 | Pages 72 - 79
18 Jan 2023
Welling MM Warbroek K Khurshid C van Oosterom MN Rietbergen DDD de Boer MGJ Nelissen RGHH van Leeuwen FWB Pijls BG Buckle T

Aims. Arthroplasty surgery of the knee and hip is performed in two to three million patients annually. Periprosthetic joint infections occur in 4% of these patients. Debridement, antibiotics, and implant retention (DAIR) surgery aimed at cleaning the infected prosthesis often fails, subsequently requiring invasive revision of the complete prosthetic reconstruction. Infection-specific imaging may help to guide DAIR. In this study, we evaluated a bacteria-specific hybrid tracer (. 99m. Tc-UBI. 29-41. -Cy5) and its ability to visualize the bacterial load on femoral implants using clinical-grade image guidance methods. Methods. 99m. Tc-UBI. 29-41. -Cy5 specificity for Stapylococcus aureus was assessed in vitro using fluorescence confocal imaging. Topical administration was used to highlight the location of S. aureus cultured on femoral prostheses using fluorescence imaging and freehand single photon emission CT (fhSPECT) scans. Gamma counting and fhSPECT were used to quantify the bacterial load and monitor cleaning with chlorhexidine. Microbiological culturing helped to relate the imaging findings with the number of (remaining) bacteria. Results. Bacteria could be effectively stained in vitro and on prostheses, irrespective of the presence of biofilm. Infected prostheses revealed bacterial presence on the transition zone between the head and neck, and in the screw hole. Qualitative 2D fluorescence images could be complemented with quantitative 3D fhSPECT scans. Despite thorough chlorhexidine treatments, 28% to 44% of the signal remained present in the locations of the infection that were identified using imaging, which included 500 to 2,000 viable bacteria. Conclusion. The hybrid tracer . 99m. Tc-UBI. 29-41. -Cy5 allowed effective bacterial staining. Qualitative real-time fluorescence guidance could be effectively combined with nuclear imaging that enables quantitative monitoring of the effectiveness of cleaning strategies. Cite this article: Bone Joint Res 2023;12(1):72–79


Bone & Joint Open
Vol. 2, Issue 8 | Pages 631 - 637
10 Aug 2021
Realpe AX Blackstone J Griffin DR Bing AJF Karski M Milner SA Siddique M Goldberg A

Aims. A multicentre, randomized, clinician-led, pragmatic, parallel-group orthopaedic trial of two surgical procedures was set up to obtain high-quality evidence of effectiveness. However, the trial faced recruitment challenges and struggled to maintain recruitment rates over 30%, although this is not unusual for surgical trials. We conducted a qualitative study with the aim of gathering information about recruitment practices to identify barriers to patient consent and participation to an orthopaedic trial. Methods. We collected 11 audio recordings of recruitment appointments and interviews of research team members (principal investigators and research nurses) from five hospitals involved in recruitment to an orthopaedic trial. We analyzed the qualitative data sets thematically with the aim of identifying aspects of informed consent and information provision that was either unclear, disrupted, or hindered trial recruitment. Results. Recruiters faced four common obstacles when recruiting to a surgical orthopaedic trial: patient preferences for an intervention; a complex recruitment pathway; various logistical issues; and conflicting views on equipoise. Clinicians expressed concerns that the trial may not show significant differences in the treatments, validating their equipoise. However, they experienced role conflicts due to their own preference and perceived patient preference for an intervention arm. Conclusion. This study provided initial information about barriers to recruitment to an orthopaedic randomized controlled trial. We shared these findings in an all-site investigators’ meeting and encouraged researchers to find solutions to identified barriers; this led to the successful completion of recruitment. Complex trials may benefit for using of a mixed-methods approach to mitigate against recruitment failure, and to improve patient participation and informed consent. Cite this article: Bone Jt Open 2021;2(8):631–637


Bone & Joint Open
Vol. 2, Issue 8 | Pages 583 - 593
2 Aug 2021
Kulkarni K Shah R Armaou M Leighton P Mangwani J Dias J

Aims. COVID-19 has compounded a growing waiting list problem, with over 4.5 million patients now waiting for planned elective care in the UK. Views of patients on waiting lists are rarely considered in prioritization. Our primary aim was to understand how to support patients on waiting lists by hearing their experiences, concerns, and expectations. The secondary aim was to capture objective change in disability and coping mechanisms. Methods. A minimum representative sample of 824 patients was required for quantitative analysis to provide a 3% margin of error. Sampling was stratified by body region (upper/lower limb, spine) and duration on the waiting list. Questionnaires were sent to a random sample of elective orthopaedic waiting list patients with their planned intervention paused due to COVID-19. Analyzed parameters included baseline health, change in physical/mental health status, challenges and coping strategies, preferences/concerns regarding treatment, and objective quality of life (EuroQol five-dimension questionnaire (EQ-5D), Generalized Anxiety Disorder 2-item scale (GAD-2)). Qualitative analysis was performed via the Normalization Process Theory. Results. A total of 888 patients responded. Better health, pain, and mood scores were reported by upper limb patients. The longest waiters reported better health but poorer mood and anxiety scores. Overall, 82% had tried self-help measures to ease symptoms; 94% wished to proceed with their intervention; and 21% were prepared to tolerate deferral. Qualitative analysis highlighted the overall patient mood to be represented by the terms ‘understandable’, ‘frustrated’, ‘pain’, ‘disappointed’, and ‘not happy/depressed’. COVID-19-mandated health and safety measures and technology solutions were felt to be implemented well. However, patients struggled with access to doctors and pain management, quality of life (physical and psychosocial) deterioration, and delay updates. Conclusion. This is the largest study to hear the views of this ‘hidden’ cohort. Our findings are widely relevant to ensure provision of better ongoing support and communication, mostly within the constraints of current resources. In response, we developed a reproducible local action plan to address highlighted issues. Cite this article: Bone Jt Open 2021;2(8):583–593


Bone & Joint Open
Vol. 4, Issue 7 | Pages 496 - 506
5 Jul 2023
Theunissen WWES Van der Steen MC Van Veen MR Van Douveren FQMP Witlox MA Tolk JJ

Aims. The aim of this study was to identify the information topics that should be addressed according to the parents of children with developmental dysplasia of the hip (DDH) in the diagnostic and treatment phase during the first year of life. Second, we explored parental recommendations to further optimize the information provision in DDH care. Methods. A qualitative study with semi-structured interviews was conducted between September and December 2020. A purposive sample of parents of children aged younger than one year, who were treated for DDH with a Pavlik harness, were interviewed until data saturation was achieved. A total of 20 interviews with 22 parents were conducted. Interviews were audio recorded, transcribed verbatim, independently reviewed, and coded into categories and themes. Results. Interviews revealed four fundamental information topics that should be addressed in the different phases of the DDH healthcare trajectory: general information (screening phase), patient-specific information (diagnostic and treatment phase), practical information (treatment phase), and future perspectives (treatment and follow-up phase). To further optimize the information provision in DDH care, parents wished for more accessible and trustworthy general information prior to the first hospital visit to be better prepared for the diagnosis. Furthermore, parents wanted more personalized and visually supported information for a better understanding of the nature of the disease and the reason for treatment. Conclusion. This study offers novel insights to optimize the information provision in DDH care. The main finding is the shift in information need from general information in the screening phase to patient-specific information in the diagnostic and treatment phase of DDH. Parents prefer visually-supported information, provided in a timely fashion, and tailored to their child’s situation. These recommendations potentially decrease parental anxiety, insecurity, confusion, and increase parental empowerment and treatment adherence throughout the diagnostic and treatment phase of DDH. Cite this article: Bone Jt Open 2023;4(7):496–506


Bone & Joint Open
Vol. 4, Issue 11 | Pages 873 - 880
17 Nov 2023
Swaby L Perry DC Walker K Hind D Mills A Jayasuriya R Totton N Desoysa L Chatters R Young B Sherratt F Latimer N Keetharuth A Kenison L Walters S Gardner A Ahuja S Campbell L Greenwood S Cole A

Aims. Scoliosis is a lateral curvature of the spine with associated rotation, often causing distress due to appearance. For some curves, there is good evidence to support the use of a spinal brace, worn for 20 to 24 hours a day to minimize the curve, making it as straight as possible during growth, preventing progression. Compliance can be poor due to appearance and comfort. A night-time brace, worn for eight to 12 hours, can achieve higher levels of curve correction while patients are supine, and could be preferable for patients, but evidence of efficacy is limited. This is the protocol for a randomized controlled trial of ‘full-time bracing’ versus ‘night-time bracing’ in adolescent idiopathic scoliosis (AIS). Methods. UK paediatric spine clinics will recruit 780 participants aged ten to 15 years-old with AIS, Risser stage 0, 1, or 2, and curve size (Cobb angle) 20° to 40° with apex at or below T7. Patients are randomly allocated 1:1, to either full-time or night-time bracing. A qualitative sub-study will explore communication and experiences of families in terms of bracing and research. Patient and Public Involvement & Engagement informed study design and will assist with aspects of trial delivery and dissemination. Discussion. The primary outcome is ‘treatment failure’ (Cobb angle progression to 50° or more before skeletal maturity); skeletal maturity is at Risser stage 4 in females and 5 in males, or ‘treatment success’ (Cobb angle less than 50° at skeletal maturity). The comparison is on a non-inferiority basis (non-inferiority margin 11%). Participants are followed up every six months while in brace, and at one and two years after skeletal maturity. Secondary outcomes include the Scoliosis Research Society 22 questionnaire and measures of quality of life, psychological effects of bracing, adherence, anxiety and depression, sleep, satisfaction, and educational attainment. All data will be collected through the British Spine Registry. Cite this article: Bone Jt Open 2023;4(11):873–880


Bone & Joint Open
Vol. 4, Issue 2 | Pages 87 - 95
10 Feb 2023
Deshmukh SR Kirkham JJ Karantana A

Aims. The aim of this study was to develop a core outcome set of what to measure in all future clinical research on hand fractures and joint injuries in adults. Methods. Phase 1 consisted of steps to identify potential outcome domains through systematic review of published studies, and exploration of the patient perspective through qualitative research, consisting of 25 semi-structured interviews and five focus groups. Phase 2 involved key stakeholder groups (patients, hand surgeons, and hand therapists) prioritizing the outcome domains via a three-round international Delphi survey, with a final consensus meeting to agree the final core outcome set. Results. The systematic review of 160 studies identified 74 outcome domains based on the World Health Organization International Classification of Functioning, Disability, and Health. Overall, 35 domains were generated through thematic analysis of the patient interviews and focus groups. The domains from these elements were synthesised to develop 37 outcome domains as the basis of the Delphi survey, with a further four generated from participant suggestions in Round 1. The Delphi survey identified 20 outcome domains as ‘very important’ for the core outcome set. At the consensus meeting, 27 participants from key stakeholder groups selected seven outcomes for the core outcome set: pain/discomfort with activity, pain/discomfort with rest, fine hand use/dexterity, self-hygiene/personal care, return to usual work/job, range of motion, and patient satisfaction with outcome/result. Conclusion. This set of core outcome domains is recommended as a minimum to be reported in all clinical research on hand fractures and joint injuries in adults. While this establishes what to measure, future work will focus on determining how best to measure these outcomes. By adopting this patient-centred core outcome set, consistency and comparability of studies will be improved, aiding meta-analysis and strengthening the evidence base for management of these common and impactful injuries. Cite this article: Bone Jt Open 2023;4(2):87–95