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

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Arthroplasties of the elbow, including total elbow arthroplasty, radial head arthroplasty, distal humeral hemiarthroplasty, and radiocapitellar arthroplasty, are rarely undertaken. This scoping review aims to outline the current research in this area to inform the development of future research.

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

A Core Outcome Set (COS) for treatment of adolescent idiopathic scoliosis (AIS) is essential to ensure that the most meaningful outcomes are evaluated and used consistently. Measuring the same outcomes ensures evidence from clinical trials and routine clinical practice of different treatments can be more easily compared and combined, therefore increasing the quality of the evidence base. The SPINE-COS-AYA project aims to develop a gold standard COS which can be used internationally in research and routine clinical practice to evaluate the treatment (surgical and bracing) of AIS. In this qualitative study, the views of adolescents and young adults with AIS (10-25 years of age), their family members and healthcare professionals in a UK region were sought, via interviews, on treatment outcomes. Participants were purposively recruited from a variety of sources including NHS outpatient clinics and social media. Semi-structured interviews were analysed using thematic analysis. Key findings will be presented, to include potential core outcome domains identified by the different subgroups. The core outcome domains identified in this research programme will subsequently form part of an international consensus survey to agree a COS. In future, if the COS is used by healthcare staff and researchers, it will be easier for everyone, including patients and their families, to assess which treatment works best

Objectives. This review aims to summarize the outcomes used to describe effectiveness of treatments for paediatric wrist fractures within existing literature. Method. We searched the Cochrane Library, Scopus, and Ovid Medline for studies pertaining to paediatric wrist fractures. Three authors independently identified and reviewed eligible studies. This resulted in a list of outcome domains and outcomes measures used within clinical research. Outcomes were mapped onto domains defined by the COMET collaborative. Results. Our search terms identified 4,262 different papers. Screening of titles excluded 2,975, leaving 1,287 papers to be assessed for eligibility. Of this 1,287, 30 studies were included for full analysis. Overall, five outcome domains, 16 outcome measures, and 28 measurement instruments were identified as outcomes within these studies. 24 studies used at least one measurement pertaining to the physiological/clinical outcome domain. The technical, life impact, and adverse effect domains were recorded in 23, 20, and 11 of the studies respectively. Within each domain it was common for different measurement instruments to be used to assess each outcome measure. The most commonly reported outcome measures were range of movement, a broad array of “radiological measures” and pain intensity, which were used in 24, 23, and 12 of the 30 studies. Conclusion. This study highlights the heterogeneity in outcomes reported within clinical effectiveness studies of paediatric wrist fractures. We provided an overview of the types of outcomes reported in paediatric wrist fracture studies and identified a list of potentially relevant outcomes required for the development of a core outcome set

Background. Exercise is a complex intervention, and often has more than one treatment target. Results from randomised controlled trials (RCTs) of exercise interventions for chronic low back pain (CLBP) typically show small to moderate effect sizes, but these may differ where outcomes better reflect the targets of interventions. This review aimed to describe what treatment targets, outcome domains and primary outcome measures are used in exercise RCTs, and examined how well the selected outcome domains match the treatment targets used in each RCT. Methods and Results. A computer-aided literature search was performed in eight databases, from inception to August 2018. Inclusion criteria: RCTs in CLBP, exercise compared to a non-exercise arm, sample size >60 per arm. Title and abstract review, subsequent full text review, data extraction and risk of bias assessment were independently undertaken by pairs of reviewers. Of 18251 initially identified titles and abstracts, 23 trials were included in the review. 30 treatment targets were extracted, and 6 primary outcome domains identified. A logic model of the treatment targets and outcomes demonstrated diverse relationships. Only 5 RCTs matched their primary outcome domain to the identified treatment targets, 12 used primary outcomes that did not match the reported treatment targets, and 6 were partially matched. Conclusion. The majority of included trials did not match the primary outcome domain to the treatment targets of the exercise intervention. Further research will explore if better matching between treatment targets and outcomes may change the conclusions of exercise trials in CLBP. No conflicts of interest. Sources of Funding: This PhD is funded by the Research Institute for Primary Care and Health Sciences, Keele University. Prof NE Foster is a UK National Institute for Health Research Senior Investigator, and was supported by a UK National Institute for Health Research Professorship (NIHR-RP-011-015). The views expressed in this publication are those of the authors and not necessarily those of the NHS, the NIHR or the Department of Health

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

There are numerous patient satisfaction questionnaires by none specific for an Independent Medical Examination (IME). The aim of this study was to develop and evaluate a questionnaire suitable for an IME. The questionnaire (IMESQ) consisted of five process domains (“Interpersonal manner”, “Communication”, “Technical ability”, “Information exchange”, “Time allocation”) and an outcome domain (“Satisfaction”), each with a five-scale Likert response. An 11-point numerical satisfaction scale (NSS) and a 3-point scale question on the “willing to undergo another examination with the doctor if required” were alternative measures of validation. The questionnaire was tested against numerous independent variables. Statistical analysis included Spearman correlation ((r. S. ) between the items in the questionnaire and the total score with the NSS, and “willing to undergo another examination with the doctor if required” with point-biserial correlation (r. pb. ). Internal consistent reliability was tested using split-half correlation coefficient (r. SB. ) and Cronbach's alpha coefficient (α). The construct was subjected to Factor Analysis. The results from 53 respondents were analysed. There was moderate to strong inter-item correlation (r. s. range 0.57 to 0.83, median 0.67, p < 0.01) and good correlation with the NSS (r. s. = 0.79, p < 0.01) and dichotomous question (r. pb. = 0.45, p < 0.01). Five respondents were “neither satisfied or dissatisfied” (Item 6) and 12 recorded “maybe” to further examination. The split-half correlation was strong (r. SB. = 0.76, p < 0.01). There was good internal consistency reliability (α = 0.92). “Interpersonal manner” (ψ = 4.3) was the only item to have an eigenvalue greater than one, accounting to 72% of the variance across the scale. Eigenvector analysis confirmed the questionnaire was unidimentional. The IMESQ is a brief questionnaire to assess satisfaction with an IME. It is validated and has good internal consistency reliability. The five process domains can identify areas of suboptimal performance: useful for a 360° audit

Aims. To determine the value of scoliosis surgery, it is necessary to evaluate outcomes in domains that matter to patients. Since randomized trials on adolescent idiopathic scoliosis (AIS) are scarce, prospective cohort studies with comparable outcome measures are important. To enhance comparison, a core set of patient-related outcome measures is available. The aim of this study was to evaluate the outcomes of AIS fusion surgery at two-year follow-up using the core outcomes set. Methods. AIS patients were systematically enrolled in an institutional registry. In all, 144 AIS patients aged ≤ 25 years undergoing primary surgery (median age 15 years (interquartile range 14 to 17) were included. Patient-reported (condition-specific and health-related quality of life (QoL); functional status; back and leg pain intensity) and clinician-reported outcomes (complications, revision surgery) were recorded. Changes in patient-reported outcome measures (PROMs) were analyzed using Friedman’s analysis of variance. Clinical relevancy was determined using minimally important changes (Scoliosis Research Society (SRS)-22r), cut-off values for relevant effect on functioning (pain scores) and a patient-acceptable symptom state (PASS; Oswestry Disability Index). Results. At baseline, 65 out of 144 patients (45%) reported numerical rating scale (NRS) back pain scores > 5. All PROMs significantly improved at two-year follow-up. Mean improvements in SRS-22r function (+ 1.2 (SD 0.6)), pain (+ 0.6 (SD 0.8)), and self-image (+ 1.1 (SD 0.7)) domain scores, and the SRS-22r total score (+ 0.5 (SD 0.5)), were clinically relevant. At two-year follow-up, 14 out of 144 patients (10%) reported NRS back pain > 5. Surgical site infections did not occur. Only one patient (0.7%) underwent revision surgery. Conclusion. Relevant improvement in functioning, condition-specific and health-related QoL, self-image, and a relevant decrease in pain is shown at two-year follow-up after fusion surgery for AIS, with few adverse events. Contrary to the general perception that AIS is a largely asymptomatic condition, nearly half of patients report significant preoperative back pain, which reduced to 10% at two-year follow-up. Cite this article: Bone Joint J 2022;104-B(2):265–273

Background and purpose:. Inconsistent outcome reporting is a problematic issue in systematic reviews of clinical trials in non-specific LBP (NSLBP). To facilitate statistical pooling and improve reliability of reviews, the development of a core outcome set (COS) is recommended. In 1998, Deyo et al. proposed a standardized set of domains and measurement instruments for LBP clinical research. An international steering committee (ISC) was formed to update 1998 recommendations, and to determine, at first, which outcome domains should be included in a COS for clinical trials in NSLBP. Methods:. The ISC used the OMERACT framework 2.0 to draw a list of potential core domains. This list was presented in a 3-round Delphi survey, in which researchers, clinicians and patients were invited to participate. Criteria for consensus were established a-priori and quantitative responses were analysed together with arguments provided by Delphi participants. The ISC discussed the results and made final decisions. Results:. 280 ‘experts’ were selected and invited to participate in the Delphi survey. Response rates in the three rounds were: 52%, 50%, and 45%. A list of 41 potential core domains was presented but 28 of them did not reach sufficient consensus to be presented in the third round, where overall consensus was reached on three domains: ‘physical functioning’, ‘pain intensity’ and ‘health-related quality of life’. Conclusion:. ‘Physical functioning’, ‘pain intensity’ and ‘health-related quality of life’ were included in this COS, together with the reporting on ‘number of deaths’. The next step in the development of this COS will be to determine which measurement instruments are most fit-for-purpose to measure these outcome domains

Aims. The aim of this meta-analysis was to compare the outcome of total elbow arthroplasty (TEA) undertaken for rheumatoid arthritis (RA) with TEA performed for post-traumatic conditions with regard to implant failure, functional outcome, and perioperative complications. Materials and Methods. We completed a comprehensive literature search on PubMed, Web of Science, Embase, and the Cochrane Library and conducted a systematic review and meta-analysis. Nine cohort studies investigated the outcome of TEA between RA and post-traumatic conditions. The preferred reporting items for systematic reviews and meta-analysis (Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA)) guidelines and Newcastle-Ottawa scale were applied to assess the quality of the included studies. We assessed three major outcome domains: implant failures (including aseptic loosening, septic loosening, bushing wear, axle failure, component disassembly, or component fracture); functional outcomes (including arc of range of movement, Mayo Elbow Performance Score (MEPS), and the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire), and perioperative complications (including deep infection, intraoperative fracture, postoperative fracture, and ulnar neuropathy). Results. This study included a total of 679 TEAs for RA (n = 482) or post-traumatic conditions (n = 197). After exclusion, all of the TEAs included in this meta-analysis were cemented with linked components. Our analysis demonstrated that the RA group was associated with a higher risk of septic loosening after TEA (odds ratio (OR) 3.96, 95% confidence interval (CI) 1.11 to 14.12), while there was an increased risk of bushing wear, axle failure, component disassembly, or component fracture in the post-traumatic group (OR 4.72, 95% CI 2.37 to 9.35). A higher MEPS (standardized mean difference 0.634, 95% CI 0.379 to 0.890) was found in the RA group. There were no significant differences in arc of range of movement, DASH questionnaire, and risk of aseptic loosening, deep infection, perioperative fracture, or ulnar neuropathy. Conclusion. The aetiology of TEA surgery appears to have an impact on the outcome in terms of specific modes of implant failures. RA patients might have a better functional outcome after TEA surgery. Cite this article: Bone Joint J 2019;101-B:1489–1497

The lack of a consensus for core health outcomes that should be reported in clinical research has hampered study design and evidence synthesis. We report a United Kingdom consensus for a core outcome set (COS) for clinical trials of patients with a hip fracture. We adopted a modified nominal group technique to derive consensus on 1) which outcome domains should be measured, and 2) methods of assessment. Participants reflected a diversity of perspectives and experience. They received an evidence synthesis and postal questionnaire in advance of the consensus meeting, and ranked the importance of candidate domains and the relevance and suitability of short-listed measures. During the meeting, pre-meeting source data and questionnaire responses were summarised, followed by facilitated discussion and a final plenary session. A COS was determined using a closed voting system: a 70% consensus was required. Consensus supported a five-domain COS: mortality, pain, activities of daily living, mobility, and health-related quality of life (HRQL). Single-item measures of mortality and mobility (indoor/outdoor walking status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D - were recommended. These measures should be included as a minimum in all hip fracture trials. Other outcome measures should be added depending on the particular interventions being studied. Cite this article: Bone Joint J 2014; 96-B:1016–23

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Open lower limb fracture is a life-changing injury affecting 11.5 per 100,000 adults each year, and causes significant morbidity and resource demand on trauma infrastructures. This study aims to identify what, and how, outcomes have been reported for people following open lower limb fracture over ten years.

Background & purpose. Measurement inconsistency across clinical trials is tackled by the development of a core outcome measurement set. Four core outcome domains were recommended for clinical trials in patients with non-specific LBP (nsLBP): physical functioning, pain intensity, health-related quality of life (HRQoL), and number of deaths. This study aimed to reach consensus on core instruments to measure the first three domains. Methods & Results. The Steering Committee overseeing this project selected 17 potential core instruments for physical functioning, three for pain intensity, and five for HRQoL. Evidence on their measurement properties in nsLBP was synthesized in three systematic reviews using COSMIN methodology. Researchers, clinicians, and patients (n = 208) were invited in a Delphi survey to seek consensus on which instruments to endorse as core. Consensus was a-priori set at 67% of participants agreeing on endorsing an instrument. Two Delphi rounds were run (response rates = 44% and 41%). Agreement was reached on endorsing the Oswestry Disability Index (ODI 2.1a) for physical functioning, the Numeric Rating Scale (NRS) for pain intensity, but not on other instruments. Several participants demanded to have free of charge core instruments. Taking these results into account, the steering committee formulated the following recommendations: ODI 2.1a or 24-item Roland Morris Disability Questionnaire for physical functioning, NRS for pain intensity, Short-Form 12 or 10-item PROMIS Global Health for HRQoL. Conclusion. A core outcome measurement set is available for clinical trials in patients with nsLBP. High quality clinimetric studies directly comparing recommended and not recommended instruments are required. Conflict of interest: None. Source of funding: EUROSPINE, The Spine Society of Europe

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Open lower limb fracture is life-changing, resulting in substantial morbidity and resource demand, while inconsistent outcome-reporting hampers systematic review and meta-analysis. A core outcome set establishes consensus among key stakeholders for the recommendation of a minimum set of outcomes. This study aims to define a core outcome set for adult open lower limb fracture.

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Chronic osteomyelitis (COM) of the lower limb in adults can be surgically managed by either limb reconstruction or amputation. This scoping review aims to map the outcomes used in studies surgically managing COM in order to aid future development of a core outcome set.

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The aim of this study was to assess the clinical and radiological results of patients who were revised using a custom-made triflange acetabular component (CTAC) for component loosening and pelvic discontinuity (PD) after previous total hip arthroplasty (THA).

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Machine-learning (ML) prediction models in orthopaedic trauma hold great promise in assisting clinicians in various tasks, such as personalized risk stratification. However, an overview of current applications and critical appraisal to peer-reviewed guidelines is lacking. The objectives of this study are to 1) provide an overview of current ML prediction models in orthopaedic trauma; 2) evaluate the completeness of reporting following the Transparent Reporting of a multivariable prediction model for Individual Prognosis Or Diagnosis (TRIPOD) statement; and 3) assess the risk of bias following the Prediction model Risk Of Bias Assessment Tool (PROBAST) tool.

Total hip and knee arthroplasty (THA, TKA) are largely successful procedures; however, both have variable outcomes, resulting in some patients being dissatisfied with the outcome. Surgeons are turning to technologies such as robotic-assisted surgery in an attempt to improve outcomes. Robust studies are needed to find out if these innovations are really benefitting patients. The Robotic Arthroplasty Clinical and Cost Effectiveness Randomised Controlled Trials (RACER) trials are multicentre, patient-blinded randomized controlled trials. The patients have primary osteoarthritis of the hip or knee. The operation is Mako-assisted THA or TKA and the control groups have operations using conventional instruments. The primary clinical outcome is the Forgotten Joint Score at 12 months, and there is a built-in analysis of cost-effectiveness. Secondary outcomes include early pain, the alignment of the components, and medium- to long-term outcomes. This annotation outlines the need to assess these technologies and discusses the design and challenges when conducting such trials, including surgical workflows, isolating the effect of the operation, blinding, and assessing the learning curve. Finally, the future of robotic surgery is discussed, including the need to contemporaneously introduce and evaluate such technologies.

Cite this article: Bone Joint J 2024;106-B(2):114–120.