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The Bone & Joint Journal
Vol. 106-B, Issue 10 | Pages 1190 - 1196
1 Oct 2024
Gelfer Y McNee AE Harris JD Mavrotas J Deriu L Cashman J Wright J Kothari A

Aims. The aim of this study was to gain a consensus for best practice of the assessment and management of children with idiopathic toe walking (ITW) in order to provide a benchmark for practitioners and guide the best consistent care. Methods. An established Delphi approach with predetermined steps and degree of agreement based on a standardized protocol was used to determine consensus. The steering group members and Delphi survey participants included members from the British Society of Children’s Orthopaedic Surgery (BSCOS) and the Association of Paediatric Chartered Physiotherapists (APCP). The statements included definition, assessment, treatment indications, nonoperative and operative interventions, and outcomes. Descriptive statistics were used for analysis of the Delphi survey results. The AGREE checklist was followed for reporting the results. Results. A total of 227 participants (54% APCP and 46% BSCOS members) completed the first round, and 222 participants (98%) completed the second round. Out of 54 proposed statements included in the first round Delphi, 17 reached ‘consensus in’, no statements reached ‘consensus out’, and 37 reached ‘no consensus’. These 37 statements were then discussed, reworded, amalgamated, or deleted before the second round Delphi of 29 statements. A total of 12 statements reached ‘consensus in’, four ‘consensus out’, and 13 ‘no consensus’. In the final consensus meeting, 13 statements were voted upon. Five were accepted, resulting in a total of 31 approved statements. Conclusion. In the aspects of practice where sufficient evidence is not available, a consensus statement can provide a strong body of opinion that acts as a benchmark for excellence in clinical care. This statement can assist clinicians managing children with ITW to ensure consistent and reliable practice, and reduce geographical variability in practice and outcomes. It will enable those treating ITW to share the published consensus document with both carers and patient groups. Cite this article: Bone Joint J 2024;106-B(10):1190–1196


Bone & Joint Open
Vol. 5, Issue 9 | Pages 736 - 741
4 Sep 2024
Farr S Mataric T Kroyer B Barik S

Aims. The paediatric trigger thumb is a distinct clinical entity with unique anatomical abnormalities. The aim of this study was to present the long-term outcomes of A1 pulley release in idiopathic paediatric trigger thumbs based on established patient-reported outcome measures. Methods. This study was a cross-sectional, questionnaire-based study conducted at a tertiary care orthopaedic centre. All cases of idiopathic paediatric trigger thumbs which underwent A1 pulley release between 2004 and 2011 and had a minimum follow-up period of ten years were included in the study. The abbreviated version of the Disabilities of Arm, Shoulder and Hand questionnaire (QuickDASH) was administered as an online survey, and ipsi- and contralateral thumb motion was assessed. Results. A total of 67 patients completed the survey, of whom 63 (94%) had full interphalangeal joint extension or hyperextension. Severe metacarpophalangeal joint hyperextension (> 40°) was documented in 15 cases (22%). The median QuickDASH score was 0 (0 to 61), indicating excellent function at a median follow-up of 15 years (10 to 19). Overall satisfaction was high, with 56 patients (84%) reporting the maximal satisfaction score of 5. Among 37 patients who underwent surgery at age ≤ two years, 34 (92%) reported the largest satisfaction, whereas this was the case for 22 of 30 patients (73%) with surgery at aged > two years (p = 0.053). Notta’s nodule resolved in 49 patients (73%) at final follow-up. No residual triggering or revision surgery was observed. Conclusion. Surgical release of A1 pulley in paediatric trigger thumb is an acceptable procedure with excellent functional long-term outcomes. There was a trend towards higher satisfaction with earlier surgery among the patients. Cite this article: Bone Jt Open 2024;5(9):736–741


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 623 - 630
1 Jun 2024
Perry DC Dritsaki M Achten J Appelbe D Knight R Widnall J Roland D Messahel S Costa ML Mason J

Aims

The aim of this trial was to assess the cost-effectiveness of a soft bandage and immediate discharge, compared with rigid immobilization, in children aged four to 15 years with a torus fracture of the distal radius.

Methods

A within-trial economic evaluation was conducted from the UK NHS and personal social services (PSS) perspective, as well as a broader societal point of view. Health resources and quality of life (the youth version of the EuroQol five-dimension questionnaire (EQ-5D-Y)) data were collected, as part of the Forearm Recovery in Children Evaluation (FORCE) multicentre randomized controlled trial over a six-week period, using trial case report forms and patient-completed questionnaires. Costs and health gains (quality-adjusted life years (QALYs)) were estimated for the two trial treatment groups. Regression was used to estimate the probability of the new treatment being cost-effective at a range of ‘willingness-to-pay’ thresholds, which reflect a range of costs per QALY at which governments are typically prepared to reimburse for treatment.


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 501 - 507
1 May 2024
Galloway AM Keene DJ Anderson A Holton C Redmond AC Siddle HJ Richards S Perry DC

Aims. The aim of this study was to produce clinical consensus recommendations about the non-surgical treatment of children with Perthes’ disease. The recommendations are intended to support clinical practice in a condition for which there is no robust evidence to guide optimal care. Methods. A two-round, modified Delphi study was conducted online. An advisory group of children’s orthopaedic specialists consisting of physiotherapists, surgeons, and clinical nurse specialists designed a survey. In the first round, participants also had the opportunity to suggest new statements. The survey included statements related to ‘Exercises’, ‘Physical activity’, ‘Education/information sharing’, ‘Input from other services’, and ‘Monitoring assessments’. The survey was shared with clinicians who regularly treat children with Perthes’ disease in the UK using clinically relevant specialist groups and social media. A predetermined threshold of ≥ 75% for consensus was used for recommendation, with a threshold of between 70% and 75% being considered as ‘points to consider’. Results. A total of 40 participants took part in the first round, of whom 31 completed the second round. A total of 87 statements were generated by the advisory group and included in the first round, at the end of which 31 achieved consensus and were removed from the survey, and an additional four statements were generated. A total of 60 statements were included in the second round and 45 achieved the threshold for consensus from both rounds, with three achieving the threshold for ‘points to consider’. The recommendations predominantly included self-management, particularly relating to advice about exercise and education for children with Perthes’ disease and their families. Conclusion. Children’s orthopaedic specialists have reached consensus on recommendations for non-surgical treatment in Perthes’ disease. These statements will support decisions made in clinical practice and act as a foundation to support clinicians in the absence of robust evidence. The dissemination of these findings and the best way of delivering this care needs careful consideration, which we will continue to explore. Cite this article: Bone Joint J 2024;106-B(5):501–507


Bone & Joint Open
Vol. 4, Issue 11 | Pages 825 - 831
1 Nov 2023
Joseph PJS Khattak M Masudi ST Minta L Perry DC

Aims

Hip disease is common in children with cerebral palsy (CP) and can decrease quality of life and function. Surveillance programmes exist to improve outcomes by treating hip disease at an early stage using radiological surveillance. However, studies and surveillance programmes report different radiological outcomes, making it difficult to compare. We aimed to identify the most important radiological measurements and develop a core measurement set (CMS) for clinical practice, research, and surveillance programmes.

Methods

A systematic review identified a list of measurements previously used in studies reporting radiological hip outcomes in children with CP. These measurements informed a two-round Delphi study, conducted among orthopaedic surgeons and specialist physiotherapists. Participants rated each measurement on a nine-point Likert scale (‘not important’ to ‘critically important’). A consensus meeting was held to finalize the CMS.


The Bone & Joint Journal
Vol. 105-B, Issue 7 | Pages 815 - 820
1 Jul 2023
Mitchell PD Abraham A Carpenter C Henman PD Mavrotas J McCaul J Sanghrajka A Theologis T

Aims. The aim of this study was to determine the consensus best practice approach for the investigation and management of children (aged 0 to 15 years) in the UK with musculoskeletal infection (including septic arthritis, osteomyelitis, pyomyositis, tenosynovitis, fasciitis, and discitis). This consensus can then be used to ensure consistent, safe care for children in UK hospitals and those elsewhere with similar healthcare systems. Methods. A Delphi approach was used to determine consensus in three core aspects of care: 1) assessment, investigation, and diagnosis; 2) treatment; and 3) service, pathways, and networks. A steering group of paediatric orthopaedic surgeons created statements which were then evaluated through a two-round Delphi survey sent to all members of the British Society for Children’s Orthopaedic Surgery (BSCOS). Statements were only included (‘consensus in’) in the final agreed consensus if at least 75% of respondents scored the statement as critical for inclusion. Statements were discarded (‘consensus out’) if at least 75% of respondents scored them as not important for inclusion. Reporting these results followed the Appraisal Guidelines for Research and Evaluation. Results. A total of 133 children’s orthopaedic surgeons completed the first survey, and 109 the second. Out of 43 proposed statements included in the initial Delphi, 32 reached ‘consensus in’, 0 ‘consensus out’, and 11 ‘no consensus’. These 11 statements were then reworded, amalgamated, or deleted before the second Delphi round of eight statements. All eight were accepted as ‘consensus in’, resulting in a total of 40 approved statements. Conclusion. In the many aspects of medicine where relevant evidence is not available for clinicians to base their practice, a Delphi consensus can provide a strong body of opinion that acts as a benchmark for good quality clinical care. We would recommend clinicians managing children with musculoskeletal infection follow the guidance in the consensus statements in this article, to ensure care in all medical settings is consistent and safe. Cite this article: Bone Joint J 2023;105-B(7):815–820


Bone & Joint Open
Vol. 4, Issue 3 | Pages 120 - 128
1 Mar 2023
Franco H Saxby N Corlew DS Perry DC Pigeolet M

Aims. Within healthcare, several measures are used to quantify and compare the severity of health conditions. Two common measures are disability weight (DW), a context-independent value representing severity of a health state, and utility weight (UW), a context-dependent measure of health-related quality of life. Neither of these measures have previously been determined for developmental dysplasia of the hip (DDH). The aim of this study is to determine the DW and country-specific UWs for DDH. Methods. A survey was created using three different methods to estimate the DW: a preference ranking exercise, time trade-off exercise, and visual analogue scale (VAS). Participants were fully licensed orthopaedic surgeons who were contacted through national and international orthopaedic organizations. A global DW was calculated using a random effects model through an inverse-variance approach. A UW was calculated for each country as one minus the country-specific DW composed of the time trade-off exercise and VAS. Results. Over a four-month period, 181 surgeons participated in the survey, with 116 surgeons included in the final analysis. The global DW calculated to be 0.18 (0.11 to 0.24), and the country-specific UWs ranged from 0.26 to 0.89. Conclusion. This is the first time that a global disability weight and country-specific utility weights have been estimated for DDH, which should assist in economic evaluations and the development of health policy. The methodology may be applied to other orthopaedic conditions. Cite this article: Bone Jt Open 2023;4(3):120–128


The Bone & Joint Journal
Vol. 105-B, Issue 2 | Pages 209 - 214
1 Feb 2023
Aarvold A Perry DC Mavrotas J Theologis T Katchburian M

Aims

A national screening programme has existed in the UK for the diagnosis of developmental dysplasia of the hip (DDH) since 1969. However, every aspect of screening and treatment remains controversial. Screening programmes throughout the world vary enormously, and in the UK there is significant variation in screening practice and treatment pathways. We report the results of an attempt by the British Society for Children’s Orthopaedic Surgery (BSCOS) to identify a nationwide consensus for the management of DDH in order to unify treatment and suggest an approach for screening.

Methods

A Delphi consensus study was performed among the membership of BSCOS. Statements were generated by a steering group regarding aspects of the management of DDH in children aged under three months, namely screening and surveillance (15 questions), the technique of ultrasound scanning (eight questions), the initiation of treatment (19 questions), care during treatment with a splint (ten questions), and on quality, governance, and research (eight questions). A two-round Delphi process was used and a consensus document was produced at the final meeting of the steering group.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1089 - 1094
1 Sep 2022
Banskota B Yadav P Rajbhandari A Aryal R Banskota AK

Aims. To examine the long-term outcome of arthrodesis of the hip undertaken in a paediatric population in treating painful arthritis of the hip. In our patient population, most of whom live rurally in hilly terrain and have limited healthcare access and resources, hip arthrodesis has been an important surgical option for the monoarticular painful hip in a child. Methods. A follow-up investigation was undertaken on a cohort of 28 children previously reported at a mean of 4.8 years. The present study looked at 26 patients who had an arthrodesis of the hip as a child at a mean follow-up of 20 years (15 to 29). Results. The mean Harris Hip Score (HHS) increased from 39.60 (SD 11.06) preoperatively to 81.02 (SD 8.86; p = 0.041) at final review. At latest follow-up, the HHS was found to be excellent in four patients (15%), good in 11 (42%), and fair in 11 (42%). A total of 16 patients (62%) reported mild low back pain, five (19%) had moderate pain, and five (19%) patients had no back pain. Mild ipsilateral knee pain was reported by 19 (73%), moderate pain by one (4%), and no pain by six (23%) patients. Mild contralateral hip pain was reported by ten patients (38%), and no pain by 16 (62%). The 36-Item Short Form Health Survey scores were very good in four patients (15%), good in 18 (70%), and poor in four (15%), with a mean score of 70.92 (SD 12.65). Of 13 female patients who had given birth, 12 did so with uncomplicated vaginal delivery. All patients had to modify their posture for toileting, putting on lower body clothes, foot care, and putting on shoes. Conclusion. Our results show that with hip arthrodesis, most patients have relatively good function at long-term follow-up, although some pain is experienced in adjacent joints, and modification in some activities of daily living is common. Cite this article: Bone Joint J 2022;104-B(9):1089–1094


The Bone & Joint Journal
Vol. 104-B, Issue 6 | Pages 758 - 764
1 Jun 2022
Gelfer Y Davis N Blanco J Buckingham R Trees A Mavrotas J Tennant S Theologis T

Aims. The aim of this study was to gain an agreement on the management of idiopathic congenital talipes equinovarus (CTEV) up to walking age in order to provide a benchmark for practitioners and guide consistent, high-quality care for children with CTEV. Methods. The consensus process followed an established Delphi approach with a predetermined degree of agreement. The process included the following steps: establishing a steering group; steering group meetings, generating statements, and checking them against the literature; a two-round Delphi survey; and final consensus meeting. The steering group members and Delphi survey participants were all British Society of Children’s Orthopaedic Surgery (BSCOS) members. Descriptive statistics were used for analysis of the Delphi survey results. The Appraisal of Guidelines for Research & Evaluation checklist was followed for reporting of the results. Results. The BSCOS-selected steering group, the steering group meetings, the Delphi survey, and the final consensus meeting all followed the pre-agreed protocol. A total of 153/243 members voted in round 1 Delphi (63%) and 132 voted in round 2 (86%). Out of 61 statements presented to round 1 Delphi, 43 reached ‘consensus in’, no statements reached ‘consensus out’, and 18 reached ‘no consensus’. Four statements were deleted and one new statement added following suggestions from round 1. Out of 15 statements presented to round 2, 12 reached ‘consensus in’, no statements reached ‘consensus out’, and three reached ‘no consensus’ and were discussed and included following the final consensus meeting. Two statements were combined for simplicity. The final consensus document includes 57 statements allocated into six successive stages. Conclusion. We have produced a consensus document for the treatment of idiopathic CTEV up to walking age. This will provide a benchmark for standard of care in the UK and will help to reduce geographical variability in treatment and outcomes. Appropriate dissemination and implementation will be key to its success. Cite this article: Bone Joint J 2022;104-B(6):758–764


Bone & Joint Open
Vol. 3, Issue 1 | Pages 98 - 106
27 Jan 2022
Gelfer Y Leo DG Russell A Bridgens A Perry DC Eastwood DM

Aims

To identify the minimum set of outcomes that should be collected in clinical practice and reported in research related to the care of children with idiopathic congenital talipes equinovarus (CTEV).

Methods

A list of outcome measurement tools (OMTs) was obtained from the literature through a systematic review. Further outcomes were collected from patients and families through a questionnaire and interview process. The combined list, as well as the appropriate follow-up timepoint, was rated for importance in a two-round Delphi process that included an international group of orthopaedic surgeons, physiotherapists, nurse practitioners, patients, and families. Outcomes that reached no consensus during the Delphi process were further discussed and scored for inclusion/exclusion in a final consensus meeting involving international stakeholder representatives of practitioners, families, and patient charities.


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1821 - 1830
1 Dec 2021
Marson BA Manning JC James M Craxford S Deshmukh SR Perry DC Ollivere BJ

Aims. The aim of this study is to develop a core set of outcome domains that should be considered and reported in all future trials of childhood limb fractures. Methods. A four-phase study was conducted to agree a set of core outcome domains. Identification of candidate outcome domains were identified through systematic review of trials, and outcome domains relevant to families were identified through semi-structured interviews with 20 families (parent-child pairing or group). Outcome domains were prioritized using an international three-round Delphi survey with 205 panellists and then condensed into a core outcome set through a consensus workshop with 30 stakeholders. Results. The systematic review and interviews identified 85 outcome domains as relevant to professionals or families. The Delphi survey prioritized 30 upper and 29 lower limb outcome domains at first round, an additional 17 upper and 18 lower limb outcomes at second round, and four additional outcomes for upper and lower limb at the third round as important domains. At the consensus workshop, the core outcome domains were agreed as: 1) pain and discomfort; 2) return to physical and recreational activities; 3) emotional and psychosocial wellbeing; 4) complications from the injury and treatment; 5) rturn to baseline activities daily living; 6) participation in learning; 7) appearance and deformity; and 8) time to union. In addition, 9a) recovery of mobility and 9b) recovery of manual dexterity was recommended as a core outcome for lower and upper limb fractures, respectively. Conclusion. This set of core outcome domains is recommended as a minimum set of outcomes to be reported in all trials. It is not an exhaustive set and further work is required to identify what outcome tools should be used to measure each of these outcomes. Adoption of this outcome set will improve the consistency of research for these children that can be combined for more meaningful meta-analyses and policy development. Cite this article: Bone Joint J 2021;103-B(12):1821–1830


Bone & Joint Open
Vol. 2, Issue 4 | Pages 255 - 260
15 Apr 2021
Leo DG Russell A Bridgens A Perry DC Eastwood DM Gelfer Y

Aims. This study aims to define a set of core outcomes (COS) to allow consistent reporting in order to compare results and assist in treatment decisions for idiopathic clubfoot. Methods. A list of outcomes will be obtained in a three-stage process from the literature and from key stakeholders (patients, parents, surgeons, and healthcare professionals). Important outcomes for patients and parents will be collected from a group of children with idiopathic clubfoot and their parents through questionnaires and interviews. The outcomes identified during this process will be combined with the list of outcomes previously obtained from a systematic review, with each outcome assigned to one of the five core areas defined by the Outcome Measures Recommended for use in Randomized Clinical Trials (OMERACT). This stage will be followed by a two round Delphi survey aimed at key stakeholders in the management of idiopathic clubfoot. The final outcomes list obtained will then be discussed in a consensus meeting of representative key stakeholders. Conclusion. The inconsistency in outcomes reporting in studies investigating idiopathic clubfoot has made it difficult to define the success rate of treatments and to compare findings between studies. The development of a COS seeks to define a minimum standard set of outcomes to collect in all future clinical trials for this condition, to facilitate comparisons between studies and to aid decisions in treatment. Cite this article: Bone Jt Open 2021;2(4):255–260


Bone & Joint Open
Vol. 2, Issue 2 | Pages 86 - 92
10 Feb 2021
Ibrahim Y Huq S Shanmuganathan K Gille H Buddhdev P

Aims

This observational study examines the effect of the COVID-19 pandemic upon the paediatric trauma burden of a district general hospital. We aim to compare the nature and volume of the paediatric trauma during the first 2020 UK lockdown period with the same period in 2019.

Methods

Prospective data was collected from 23 March 2020 to 14 June 2020 and compared with retrospective data collected from 23 March 2019 to 14 June 2019. Patient demographics, mechanism of injury, nature of the injury, and details of any surgery were tabulated and statistically analyzed using the independent-samples t-test for normally distributed data and the Mann-Whitney-U test for non-parametric data. Additionally, patients were contacted by telephone to further explore the mechanism of injury where required, to gain some qualitative insight into the risk factors for injury.


Bone & Joint Open
Vol. 1, Issue 12 | Pages 720 - 730
1 Dec 2020
Galloway AM van-Hille T Perry DC Holton C Mason L Richards S Siddle HJ Comer C

Aims

Perthes’ disease is a condition leading to necrosis of the femoral head. It is most common in children aged four to nine years, affecting around one per 1,200 children in the UK. Management typically includes non-surgical treatment options, such as physiotherapy with/without surgical intervention. However, there is significant variation in care with no consensus on the most effective treatment option.

Methods

This systematic review aims to evaluate the effectiveness of non-surgical interventions for the treatment of Perthes’ disease. Comparative studies (experimental or observational) of any non-surgical intervention compared directly with any alternative intervention (surgical, non-surgical or no intervention) were identified from: Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), EMcare, Allied and Complementary Medicine Database (AMED), and the Physiotherapy Evidence Database (PEDro). Data were extracted on interventions compared and methodological quality. For post-intervention primary outcome of radiological scores (Stulberg and/or Mose), event rates for poor scores were calculated with significance values. Secondary outcomes included functional measures, such as range of movement, and patient-reported outcomes such as health-related quality of life.


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1767 - 1773
1 Dec 2020
Maikku M Ohtonen P Valkama M Leppilahti J

Aims

We aimed to determine hip-related quality of life and clinical findings following treatment for neonatal hip instability (NHI) compared with age- and sex-matched controls. We hypothesized that NHI would predispose to hip discomfort in long-term follow-up.

Methods

We invited those born between 1995 and 2001 who were treated for NHI at our hospital to participate in this population-based study. We included those that had Von Rosen-like splinting treatment started before one month of age. A total of 96 patients treated for NHI (75.6 %) were enrolled. A further 94 age- and sex-matched controls were also recruited. The Copenhagen Hip and Groin Outcome Score (HAGOS) questionnaire was completed separately for both hips, and a physical examination was performed.


Bone & Joint Open
Vol. 1, Issue 11 | Pages 691 - 695
1 Nov 2020
Galloway AM Holton C Parnami V Wood M Craven J Green N Siddle HJ Richards S Comer C

Aims

Perthes’ disease is a condition which leads to necrosis of the femoral head. It is most commonly reported in children aged four to nine years, with recent statistics suggesting it affects around five per 100,000 children in the UK. Current treatment for the condition aims to maintain the best possible environment for the disease process to run its natural course. Management typically includes physiotherapy with or without surgical intervention. Physiotherapy intervention often will include strengthening/stretching programmes, exercise/activity advice, and, in some centres, will include intervention, such as hydrotherapy. There is significant variation in care with no consensus on which treatment option is best. The importance of work in this area has been demonstrated by the British Society for Children’s Orthopaedic Surgery through the James Lind Alliance’s prioritization of work to determine/identify surgical versus non-surgical management of Perthes’ disease. It was identified as the fourth-highest priority for paediatric lower limb surgery research in 2018.

Methods

Five UK NHS centres, including those from the NEWS (North, East, West and South Yorkshire) orthopaedic group, contributed to this case review, with each entre providing clinical data from a minimum of five children. Information regarding both orthopaedic and physiotherapeutic management over a two-year post-diagnosis period was reviewed.


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1582 - 1586
1 Nov 2020
Håberg Ø Foss OA Lian ØB Holen KJ

Aims

To assess if congenital foot deformity is a risk factor for developmental dysplasia of the hip (DDH).

Methods

Between 1996 and 2012, 60,844 children were born in Sør-Trøndelag county in Norway. In this cohort study, children with risk factors for DDH were examined using ultrasound. The risk factors evaluated were clinical hip instability, breech delivery, a family history of DDH, a foot deformity, and some syndromes. As the aim of the study was to examine the risk for DDH and foot deformity in the general population, children with syndromes were excluded. The information has been prospectively registered and retrospectively analyzed.


Aims

Torus fractures of the distal radius are the most common fractures in children. The NICE non-complex fracture guidelines recently concluded that bandaging was probably the optimal treatment for these injuries. However, across the UK current treatment varies widely due to a lack of evidence underpinning the guidelines. The Forearm Fracture Recovery in Children Evaluation (FORCE) trial evaluates the effect of a soft bandage and immediate discharge compared with rigid immobilization.

Methods

FORCE is a multicentre, parallel group randomized controlled equivalence trial. The primary outcome is the Wong-Baker FACES pain score at three days after randomization and the primary analysis of this outcome will use a multivariate linear regression model to compare the two groups. Secondary outcomes are measured at one and seven days, and three and six-weeks post-randomization and include the Patient Reported Outcome Measurement Information System (PROMIS) upper extremity limb score, EuroQoL EQ-5D-Y, analgesia use, school absence, complications, and healthcare resource use. The planned statistical and health economic analyses for this trial are described here. The FORCE trial protocol has been published separately.


The Bone & Joint Journal
Vol. 102-B, Issue 5 | Pages 611 - 617
1 May 2020
Leo DG Jones H Murphy R Leong JW Gambling T Long AF Laine J Perry DC

Aims. To identify a suite of the key physical, emotional, and social outcomes to be employed in clinical practice and research concerning Perthes' disease in children. Methods. The study follows the guidelines of the COMET-Initiative (Core Outcome Measures in Effectiveness Trials). A systematic review of the literature was performed to identify a list of outcomes reported in previous studies, which was supplemented by a qualitative study exploring the experiences of families affected by Perthes’ disease. Collectively, these outcomes formed the basis of a Delphi survey (two rounds), where 18 patients with Perthes’ disease, 46 parents, and 36 orthopaedic surgeons rated each outcome for importance. The International Perthes Study Group (IPSG) (Dallas, Texas, USA (October 2018)) discussed outcomes that failed to reach any consensus (either ‘in’ or ‘out’) before a final consensus meeting with representatives of surgeons, patients, and parents. Results. In total, 23 different outcome domains were identified from the systematic review, and a further ten from qualitative interviews. After round one of the Delphi survey, participants suggested five further outcome domains. A total of 38 outcomes were scored in round two of the Delphi. Among these, 16 outcomes were scored over the prespecified 70% threshold for importance (divided into six main categories: adverse events; life impact; resource use; pathophysiological manifestations; death; and technical considerations). Following the final consensus meeting, 14 outcomes were included in the final Core Outcome Set (COS). Conclusion. Core Outcome Sets (COSs) are important to improve standardization of outcomes in clinical research and to aid communication between patients, clinicians, and funding bodies. The results of this study should be a catalyst to develop high-quality clinical research in order to determine the optimal treatments for children with Perthes’ disease. Cite this article: Bone Joint J 2020;102-B(5):611–617