Purpose: A systematic review of Health Related Quality of Life Outcomes(HRQOL) in metastatic disease of the spine and content validation of a new Spine Oncology Study Group Outcomes Questionnaire(SOSGOQ). To identify HRQOL questionnaires previously reported for spinal metastases and to validate the content of the new SOSGOQ based on the International Classification of Function and disability(ICF).

Method: A systematic review identified 141 studies. Reported outcome tools were enumerated. The most commonly utilized (ESAS, Karnofsky Scale and ODI) and the SOSGOQ were linked to the ICF. Descriptive statistics examined the frequency and specificity of the ICF linkage. Linkage reliability was evaluated by inter-investigator percentage agreement.

Results: The SOSGOQ contains 56 concepts, with all 4 domains of the ICF represented. 4 concepts could not be linked. There was 100% inter-observer agreement(IOA) for total number of concepts and for those ‘not covered’. 100% of concepts had ‘First and Second’ level linkage. 100% IOA exists at both ‘Component’ and “First Level’ linkage. There was 96.1% IOA at ‘Second’ Level. 33 concepts linked to Third Level with 96.9% IOA. 10 concepts linked at the Fourth Level with 100% IOA.

Conclusion: The SOSGOQ includes all domains relevant for measurement of function and disability and it’s content validity is confirmed by linkage with the ICF. This new questionnaire has superior content capacity to measure disease burden of patients with metastatic disease of the spine than any instruments previously identified in the literature.

Background. Symptoms of obstetric brachial plexus injury (OBPI) vary widely over the course of time and from individual to individual and can include various degrees of denervation, muscle weakness, contractures, bone deformities and functional limitations. To date, no universally accepted overall framework is available to assess the outcome of patients with OBPI. The objective of this paper is to outline the proposed process for the development of International Classification of Functioning, Disability and Health (ICF) Core Sets for patients with an OBPI. Methods. The first step is to conduct four preparatory studies to identify ICF categories important for OBPI: a) a systematic literature review to identify outcome measures, b) a qualitative study using focus groups, c) an expert survey and d) a cross-sectional, multicentre study. A first version of ICF Core Sets will be defined at a consensus conference, which will integrate the evidence from the preparatory studies. In a second step, field-testing among patients will validate this first version of Core Sets for OBPI. Discussion. The proposed method to develop ICF Core Sets for OBPI yields a practical tool for multiple purposes: for clinicians to systematically assess and evaluate the individual’s functioning, for researchers to design and compare studies, and for patients to get more insight into their health problems and their management

Aims. To describe outcome reporting variation and trends in non-pharmacological randomized clinical trials (RCTs) of distal tibia and/or ankle fractures. Methods. Five electronic databases and three clinical trial registries were searched (January 2000 to February 2022). Trials including patients with distal tibia and/or ankle fractures without concomitant injuries were included. One reviewer conducted all searches, screened titles and abstracts, assessed eligibility, and completed data extraction; a random 10% subset were independently assessed and extracted by a second reviewer at each stage. All extracted outcomes were mapped to a modified version of the International Classification of Functioning, Disability and Health framework. The quality of outcome reporting (reproducibility) was assessed. Results. Overall, 105 trials (n = 16 to 669 participants) from 27 countries were included. Trials compared surgical interventions (n = 62), post-surgical management options (n = 17), rehabilitative interventions (n = 14), surgical versus non-surgical interventions (n = 6), and pre-surgical management strategies (n = 5). In total, 888 outcome assessments were reported across seven domains: 263 assessed body structure or function (85.7% of trials), 136 activities (68.6% of trials), 34 participation (23.8% of trials), 159 health-related quality of life (61.9% of trials), 247 processes of care (80% of trials), 21 patient experiences (15.2% of trials), and 28 economic impact (8.6% of trials). From these, 337 discrete outcomes were described. Outcome reporting was inconsistent across trials. The quality of reporting varied widely (reproducibility ranged 4.8% patient experience to 100% complications). Conclusion. Substantial heterogeneity in outcome selection, assessment methods, and reporting quality were described. Despite the large number of outcomes, few are reported across multiple trials. Most outcomes are clinically focused, with little attention to the long-term consequences important to patients. Poor reporting quality reduces confidence in data quality, inhibiting data synthesis by which to inform care decisions. Outcome reporting guidance and standardization, which captures the outcomes that matter to multiple stakeholders, are urgently required. Cite this article: Bone Jt Open 2022;3(10):832–840

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

Aims. To analyze outcomes reported in trials of childhood fractures. Methods. OVID MEDLINE, Embase, and Cochrane CENTRAL databases were searched on the eighth August 2019. A manual search of trial registries, bibliographic review and internet search was used to identify additional studies. 11,476 studies were screened following PRISMA guidelines. 100 trials were included in the analysis. Data extraction was completed by two researchers for each trial. Study quality was not evaluated. Outcomes reported by trials were mapped onto domains in the World Health Organization (WHO) International Classification of Function framework. Results. In all, 525 outcomes were identified representing 52 WHO domains. Four domains were reported in more than 50% of trials: structure of upper/lower limb, sensation of pain, mobility of joint function, and health services, systems and policies. The Activities Scale for Kids performance (ASK-p) score was the most common outcome score reported in 6/72 upper limb and 4/28 lower limb trials. Conclusion. There is a diverse range of outcomes reported in trials of childhood fractures covering all areas in the International Classification of Functioning, Disability and Health (ICF) framework. There were three common upper limb and three common lower limb outcomes. In the absence of a core outcome set, we recommend that upper limb trials report pain, range of movement and radiograph appearance of the arm and lower limb trials report pain, radiograph appearance of the leg and healthcare costs to improve consistency of reporting in future trials. Cite this article: Bone Joint Open 2020;1-5:167–174

Introduction. Patient-reported outcome measures (PROMs) has gained momentum in the orthopaedic literature. The GOAL-LD (Gait Outcomes Assessment List for Limb Deformity) incorporates the framework of The WHO International Classification of Functioning, Disability and Health and correlates highly with the Paediatric Outcomes Data Collection Instrument (PODCI) when applied in a limb reconstruction setting. The Royal Children's Hospital Melbourne, Australia, supported by The University of Melbourne is designing and implementing a Limb Reconstruction Registry, prospectively enrolling patients with a number of key conditions and provide a mechanism for capturing surgical data and PROMs at regular follow-up intervals. LimbDREAM (The Limb Reconstruction Registry of Experience, Aspiration and Measures) has begun recruiting participants, and this paper serves as a narrative review of our design and implementation process. Materials & Methods. After provision of a research grant, audit was conducted to examine local case mix and estimate recruitment based on conditions selected. Literature review was focussed on (i) registries in the paediatric limb reconstruction domain and (ii) use of PROMs across conditions selected. A high-level process-flow chart was constructed in order to inform governance and staffing requirements in addition to REDCap Database structure. Local as well as scalable deployment was considered. Alpha and beta testing was performed by principal and associate investigators prior to participant recruitment. Results. Audit identified 6 condition streams for inclusion: Congenital limb deficiencies, congenital pseudarthrosis of the tibia, bone dysplasias, bone tumours, amputation, and complex deformity of other etiology. Literature review identified 20 PROMs used across these conditions, with limited validation studies and significant implementation heterogeneity. REDCap database design took longer than anticipated (planned 10 months, actual 18 months) before being recruitment ready, due to the complexity of ensuring data collection logic would work across highly diverse patient journeys. Initial recruitment across all streams has been promising. Email and text message reminders have proved helpful in increasing survey return rates. Conclusions. Prospective collection of PROMs as well as surgical data via a standardized dataset will provide the basis for future condition-specific research, with the ability to support nested trials. Implementation requires forethought with regard to time frames and staffing for non-automated steps as well as data integrity review. The next phase of the LimbDREAM project will be to integrate use of the Registry into our weekly Limb Reconstruction Meeting to ensure that operative plans and data are captured close to the point of care

Background Critical reflection in clinical routine and research raises the question of how we measure outcome. The classical etiopathogenetic way of thinking has led to biophysical, investigator-based, ‘objective’ parameters. However, new concepts of holistic health assessment based on the WHO’s International Classification of Functioning, Disability, and Health (ICF) emphasize the patient’s (subjective) perception. Methods We present different approaches to health and health-related quality of life assessment by applying assessment tools to specific examples and providing an overview of some of the existing instruments with an analysis of their properties. Results Self-assessments reflect the patient’s needs more closely than biophysical parameters. Reliability and validity of the self-assessments are high and population surveys provide valid norms for comparisons. Generic instruments offer a comprehensive range of measurements, and condition-specific self-assessment tools differ in their pattern of health dimensions and their sensitivity to change (responsiveness) as expressed by specific scales. A specific set of instruments has to be compiled appropriate to the focus of interest. Conclusions Self-assessments are an important complement to clinical signs as indicators of the patient’s condition and fulfill the requirements of the modern salutogenetic, holistic view of the patient as set out in the ICF concept. As a valid representation of the patient’s needs they help in the optimization of disease management and medical-economic planning

Purpose. The objective of this study was to compare items from musculoskeletal outcome questionnaires with items generated by pre- and post-operative ankle arthrodesis and arthroplasty patients (patient-selected portion of the Patient-Specific Index (PASI-P)) to determine if existing questionnaires address patients' concerns. Materials/Methods. Patients (n=142) completed the PASI-P. Items from 6 standardised questionnaires (AAOS, patient-reported portion of AOFAS, FFI, LEFS, SMFA, WOMAC) and PASI-P were matched by 3 reviewers to corresponding categories in the International Classification of Functioning, Disability and Health (ICF). The ICF classification hierarchy codes broad first categories and increasingly detailed second, third, and fourth categories. The standardised questionnaires were then compared to the ‘gold standard’ of PASI-P. Results. 690 concepts were identified in the patients' responses, which corresponded to 45 ICF categories. Most PASI-P concepts fell into Activities and Participation (60.3%) and Body Functions and Body Structures (35.2%), including the second level categories ‘walking’ (21.6%), ‘pain’ (18.7%), and ‘recreation and leisure’ (17.4%). A total of 237 concepts was identified in the 6 questionnaires and linked to 39 second level ICF categories. Overall, SMFA addressed the most second level categories and had the closest proportion of Activities and Participation (68.9%) and Body Functions (23.0%) concepts compared to the patient-generated responses. The patient-reported portion of AOFAS addressed the fewest categories. LEFS only contained items from Activities and Participation. AAOS was the only questionnaire to address the issue of ‘swelling’, though it represented 5.6% of all patient-generated responses. The concepts of ‘swelling’, ‘recreation and leisure’, and ‘sports’ were seldom included in the questionnaires. Conclusion. No single questionnaire captured all concerns identified by patients, and the standardised questionnaires differed largely in content. Clinicians should recognise patient concerns relevant to the ankle currently not included in available questionnaires. This analysis will guide the development of a more comprehensive instrument for evaluating ankle outcomes

Background The new concepts of health assessment based on the WHO’s International Classification of Functioning, Disability, and Health (ICF) require the increased use of patient self-rated outcome measurement. There is an extensive body of literature to support the concept that self-rating is far more valid than ‘objective’ parameters such as x-ray findings, range of motion etc. While the value of joint-specific assessment is obvious in rheumatoid arthritis (RA), the need for comprehensive outcome parameters may seem to be less important. We present an exemplary study which compares generic, comprehensive assessment with condition-specific assessment. Methods In a cross-sectional catamnesis study, the outcomes of patients with RA and posttraumatic (PT) elbows were compared 11 years after total elbow arthroplasty using generic and specific self-rating instruments. Results Compared to the scores recorded for the 20 PT patients, the 59 RA patients achieved mean scores of 105.6% on the Short Form 36 (SF-36) Mental Component Summary, 82.5% on the Patient Related Elbow Evaluation (PREE) function, 69.5% on the Disability of the Arm, Shoulder and Hand (DASH) function, and 60.2% on the SF-36 physical functioning (a higher score means better health). Conclusions The elbow-specific PREE revealed little functional deficits for RA compared with PT, the arm-specific DASH showed moderate, and the generic, comprehensive SF-36 demonstrated large functional deficits, whereas psychosocial health was comparable for RA and PT. Post-interventional outcomes may be similar when focusing on a specific condition or joint. Functional deficits and holistic health can only be captured by comprehensive measurement when dealing with systemic polyarticular affection like RA

Purpose: The objective of this study is to compare items from patient-reported questionnaires measuring musculoskeletal outcomes with items generated by pre-and post-operative ankle arthrodesis and arthroplasty patients using the Patient-Specific Index (PSI-P). The International Classification of Functioning, Disability and Health (ICF) was used as an external reference. Method: A literature review identified six questionnaires that assess lower extremity outcomes (AAOS, patient-reported portion of AOFAS, FFI, LEFS, SMFA, WOMAC). Surgical patients (n=142) from an orthopaedic surgeon’s practice completed the patient-selected items from PSI-P. Items from questionnaires and PSI-P were coded by three reviewers and linked to the ICF. The ICF is divided into four components (Body Functions and Structures, Activities and Participation, Environmental Factors, and Personal Factors) which are then further divided into second level categories. A higher number of second level categories would indicate a questionnaire that captures a broader range of experiences. Results: Patient’s responses from PSI-P identified 690 meaningful concepts that were linked to 45 second level ICF categories. Most PSI-P responses fell into Activities and Participation (60.6%) and Body Functions and Body Structures (35.2%) including the second level categories Walking (19.1%), Pain (16.5%), and Recreation and Leisure (15.4%). There was no statistical difference between arthrodesis and arthroplasty patients nor between pre-operative versus postoperative patients in terms of the proportion of patient responses that fell into each ICF component. A total of 237 meaningful concepts were identified in the 6 questionnaires studied and linked to 38 second level ICF categories. Overall, SMFA addressed the most number of second level categories and had the closest proportion of Body Function (23.0%) and Activities and Participation (68.9%) concepts as compared to PSI-P. The patient-reported portion of AOFAS addressed the fewest categories. LEFS only contained items from Activities and Participation. AAOS was the only questionnaire to address the issue of ‘swelling’, though it represented 4.9% of all PSI-P responses. Conclusion: Questionnaires differ largely in their content and no single questionnaire captured all of the concerns identified by PSI-P. This analysis will guide us in the development of a new and more comprehensive instrument for evaluating ankle outcomes following fusion or replacement

Purpose. No knee-specific outcome measures have demonstrated reliability, validity or responsiveness in patients with multiligament knee injuries. Furthermore, the content validity of existing questionnaires has been challenged and remains unknown for patients with concomitant neurovascular injury. As a first step in developing a disease-specific outcome measure, the objective of this study was to identify items from existing knee questionnaires pertinent to patients with multiligament knee injuries using established a priori criteria. Method. Eighty-five consecutive patients from a level one trauma centre were mailed a questionnaire comprising 124 items from 11 knee-specific instruments. They rated the frequency and importance for each item on a five-point Likert scale. Criteria for item selection included a mean importance rating (MIR) ≥ 3.5 and frequency < 30% for the response never experienced. The World Health Organization International Classification of Functioning, Disability and Health (ICF) framework was used to support the content. Results. The average age of the 60/85 respondents (70.6%) was 34.7 years and most were male (n=45). Average time from injury was 845 days. Using the Schenck classification, 19 patients were KD I, two were KD II, 39 were KD IIIL or IIIM, and nine were KD IV. Nineteen had peroneal nerve injury and five had a vascular injury. Forty-four patients were treated surgically, six nonoperatively and 10 are pre-operative. Sixty-one of 124 questionnaire items met the a priori inclusion criteria. Based on the ICF, 22 of the retained items were physical impairments (PI), 15 items were emotional impairments (EI), 18 items were activity limitations (AL), and six items were participation restrictions (PR). The 10 items with the highest MIR included six EI, one PI and three PR. Twenty-four items (PI=6 EI=13, AL=2, PR=3) of the Anterior Cruciate Ligament Quality of Life Questionnaire (ACL-QoL) satisfied the a priori criteria and this instrument also endorsed the most items within the EI and PR constructs. The Knee Osteoarthritis and Injury Outcome Score (KOOS) had 21 items (PI=7, EI=2, AL=11, PR=1) which satisfied the a priori criteria and also had the most items within the PI and AL constructs. The International Knee Documentation Committee (IKDC) Subjective Knee Form had 12 items (EI=0, PI=3, AL=9, PR=0) meeting criteria while the remaining questionnaires contained 11 items with concepts redundant to above. Combining the ACL-QoL and KOOS resulted in representation of 41/61 of the retained items (PI=13, EI=13, AL=12, PR=3). No existing instrument includes content that may result from neurological or vascular injury. Conclusion. This work has identified over sixty pertinent items across the various ICF domains relevant to patients with multiligament knee injuries. The ACL-QoL and KOOS together address over two thirds of these items. Patient and clinician focus groups will be conducted to address missing content and to further refine the questionnaire items

Aims

To systematically review the efficacy of split tendon transfer surgery on gait-related outcomes for children and adolescents with cerebral palsy (CP) and spastic equinovarus foot deformity.

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.