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Use CFIR guidance to create comprehensive, evidence-based, feasible, and acceptable gender-affirming care PROM implementation strategies. A 3-Phase participatory process was followed to design feasible and acceptable strategies for integrating PROMs in gender-affirming care. In Phase 1, barriers and enablers to PROM implementation for gender-affirming care were identified from a previous systematic review and our prior qualitative study. We used the CFIR-ERIC tool to match previously identified barriers and enablers with expert-endorsed implementation strategies. In Phase 2, implementation strategy outputs from CFIR-ERIC were organised according to cumulative percentage value. In Phase 3, gender-affirming care PROM implementation strategies underwent iterative refinement based on rounds of stakeholder feedback with seven patient and public partners and a gender-affirming healthcare professional. The systematic review and qualitative study identified barriers and enablers to PROM implementation spanning all five CFIR domains, and 30 CFIR constructs. The top healthcare professional-relevant strategies to PROM implementation from the CFIR-ERIC output include: identifying and preparing implementation champions, collecting feedback on PROM implementation, and capturing and sharing local knowledge between clinics on implementation. Top patient-relevant strategies include: having educational material on PROMs, ensuring adaptability of PROMs, and collaborating with key local organisations who may be able to support patients. This study developed evidence-based, feasible, and acceptable strategies for integrating PROMs in gender-affirming care, representing evidence from a systematic review of 286 international articles, a qualitative study of 24 gender-affirming care patients and healthcare professionals, and iteration from 7 patient and public partners and a gender-affirming healthcare professional. The finalised strategies include patient- and healthcare professional-relevant strategies for implementing PROMs in gender-affirming care. Clinicians and researchers can select and tailor implementation strategies best applying to their gender-affirming care setting.

Demonstrate psychometric sensitivity analyses for testing the stability of study findings to assumptions made about patient-reported outcome measures. We performed secondary analyses of Disability of Arm, Shoulder, and Hand (DASH) data collected within the Prevention of Shoulder Problems clinical trial, which compared upper limb function scores in women who had undergone breast cancer surgery, randomized to either an exercise program or usual care. We repeated the principal trial analyses after grouping DASH items into subscales suggested by factorial analyses in this dataset and applied item response theory to account for unequal item weighting. We checked for measurement invariance by participant age and response shift bias using established techniques. Our analyses suggested that the DASH measured two constructs: motor function and sensory symptoms. The majority of the six-month difference in DASH score was driven by motor function. With item response theory scoring, we found differences in both constructs at 12 months (P = 0.019 and P = 0.007), but in neither construct at 6 months, contrary to the original trial results. We found no differential item function by age or between baseline and 12-month measurements. Psychometric sensitivity analyses aid in the interpretation of the Prevention of Shoulder Problems trial’s results.

To develop item response theory (IRT) models for the Oxford hip and knee scores which convert patient responses into continuous scores with quantifiable precision and provide these as web applications for efficient score conversion. Data from the National Health Service patient-reported outcome measures program were used to test the assumptions of IRT (unidimensionality, monotonicity, local independence, and measurement invariance) before fitting models to preoperative response patterns obtained from patients undergoing primary elective hip or knee arthroplasty. The hip and knee datasets contained 321,147 and 355,249 patients, respectively. Scree plots, Kaiser criterion analyses, and confirmatory factor analyses confirmed unidimensionality and Mokken analysis confirmed monotonicity of both scales. In each scale, all item pairs shared a residual correlation of ≤ 0.20. At the test level, both scales showed measurement invariance by age and gender. Both scales provide precise measurement in preoperative settings but demonstrate poorer precision and ceiling effects in postoperative settings. We provide IRT parameters and web applications that can convert Oxford Hip Score or Oxford Knee Score response sets into continuous measurements and quantify individual measurement error. These can be used in sensitivity analyses or to administer truncated and individualized computerized adaptive tests.

Remote patient-reported outcome measure (PROM) data capture can provide useful insights into research and clinical practice and deeper insights can be gained by administering assessments more frequently, for example, in ecological momentary assessment. However, frequent data collection can be limited by the burden of multiple, lengthy questionnaires. This burden can be reduced with computerized adaptive testing (CAT) algorithms that select only the most relevant items from a PROM for an individual respondent. In this paper, we propose \"ecological momentary computerized adaptive testing\" (EMCAT): the use of CAT algorithms to reduce PROM response burden and facilitate high-frequency data capture via a smartphone app. We develop and pilot a smartphone app for performing EMCAT using a popular hand surgery PROM. The aim of this study is to determine the feasibility of EMCAT as a system for remote PROM administration. We built the EMCAT web app using Concerto, an open-source CAT platform maintained by the Psychometrics Centre, University of Cambridge, and hosted it on an Amazon Web Service cloud server. The platform is compatible with any questionnaire that has been parameterized with item response theory or Rasch measurement theory. For this study, the PROM we chose was the patient evaluation measure, which is commonly used in hand surgery. CAT algorithms were built using item response theory models derived from UK Hand Registry data. In the pilot study, we enrolled 40 patients with hand trauma or thumb-base arthritis, across 2 sites, between July 13, 2022, and September 14, 2022. We monitored their symptoms with the patient evaluation measure, via EMCAT, over a 12-week period. Patients were assessed thrice weekly, once daily, or thrice daily. We additionally administered full-length PROM assessments at 0, 6, and 12 weeks, and the User Engagement Scale at 12 weeks. The use of EMCAT significantly reduced the length of the PROM (median 2 vs 11 items) and the time taken to complete it (median 8.8 seconds vs 1 minute 14 seconds). Very similar scores were obtained when EMCAT was administered concurrently with the full-length PROM, with a mean error of <0.01 on a logit (z score) scale. The median response rate in the daily assessment group was 93%. The median perceived usability score of the User Engagement Scale was 4.0 (maximum possible score 5.0). EMCAT reduces the burden of PROM assessments, enabling acceptable high-frequency, remote PROM data capture. This has potential applications in both research and clinical practice. In research, EMCAT could be used to study temporal variations in symptom severity, for example, recovery trajectories after surgery. In clinical practice, EMCAT could be used to monitor patients remotely, prompting early intervention if a patient's symptom trajectory causes clinical concern. ISRCTN 19841416; https://www.isrctn.com/ISRCTN19841416.

The Oxford knee score (OKS) and OKS Activity and Participation Questionnaire (OKS-APQ) are patient-reported outcome measures used to assess people undergoing knee replacement surgery. They have not explicitly been tested for unidimensionality (whether they measure one underlying trait such as ‘knee health’). This study applied item response theory (IRT) to improve the validity of the instruments to optimize for ongoing use. Participants undergoing primary total knee replacement (TKR) provided preoperative and postoperative responses for OKS and OKS-APQ. Confirmatory factor analysis (CFA) were performed on the OKS and OKS-APQ separately and then on both when pooled into one. An IRT model was fitted to the data. 2972 individual response patterns were analyzed. CFA demonstrated that when combining OKS and OKS-APQ as one instrument, they measure one latent health trait. A user-friendly, free-to-use, web app has been developed to allow clinicians to upload raw data and instantly receive IRT scores. The OKS and OKS-APQ can be combined to use effectively as a single instrument (producing a single score). For the separate OKS and OKS-APQ the original items and response options can continue to be posed to patients, and this study has confirmed the suitability of IRT-weighted scoring. Applying IRT to existing responses converts traditional sum scores into continuous measurements with greater granularity, including individual measurement error. •The Oxford knee score and Oxford knee score-Activity and Participation Questionnaire measure one latent trait, coined as ‘knee health’.•Combining scores can potentially overcome floor and ceiling effects.•The presented web app can convert scores from tradition sumscore to item response theory scores.•Item response theory accounts for missing data, existing datasets can retain value.

To apply item response theory as a framework for studying measurement error in superiority trials which use patient-reported outcome measures (PROMs). We reanalyzed data from the The Total or Partial Knee Arthroplasty Trial, which compared the Oxford Knee Score (OKS) responses of patients undergoing partial or total knee replacement, using traditional sum-scoring, after accounting for OKS item characteristics with expected a posteriori (EAP) scoring, and after accounting for individual-level measurement error with plausible value imputation (PVI). We compared the marginalized mean scores of each group at baseline, 2 months, and yearly for 5 years. We used registry data to estimate the minimal important difference (MID) of OKS scores with sum-scoring and EAP scoring. With sum-scoring, we found statistically significant differences in mean OKS score at 2 months (P = 0.030) and 1 year (P = 0.030). EAP scores produced slightly different results, with statistically significant differences at 1 year (P = 0.041) and 3 years (P = 0.043). With PVI, there were no statistically significant differences. Psychometric sensitivity analyses can be readily performed for superiority trials using PROMs and may aid the interpretation of results.

IntroductionPeople with body mass index (BMI) ≥35 kg/m2 have an approximately 19-fold increased risk of undergoing total knee replacement (TKR); however, many UK integrated care boards (37%) have restrictive policies which limit access to TKR for people based on BMI. Therefore, access to both surgical and non-surgical treatments varies widely, exacerbating existing health inequalities. It remains unclear how decisions about offering TKR are made in people with severe knee osteoarthritis, which weight-loss interventions are provided in practice and how different management pathways relate to patient outcomes among individuals with high BMI.Methods and analysisThis study will recruit 400 participants with severe Kellgren-Lawrence grade four knee osteoarthritis from eight secondary care centres in England. All participants, irrespective of BMI, will provide baseline clinical data and patient-reported outcome measures (PROMs), enabling characterisation of baseline associations between BMI, knee function and body image.A prespecified subgroup of participants with BMI ≥35 kg/m2 (minimum n=105) will undergo longitudinal follow-up at 6 months, 12 months and 24 months, including repeat BMI measurement, PROMs and detailed data on access to surgical and non-surgical interventions, including weight-loss strategies and TKR. For those with BMI ≥35 kg/m2, statistical modelling will be used to explore associations between baseline factors and longitudinal outcomes including Oxford Knee Score and weight change at 12 months (n≥105). Structural equation modelling will be used to quantify associations between BMI and knee pain/function mediated by psychosocial factors using data from all participants (n=400). A nested qualitative study of surgeons and patients will explore obstacles and preferences in the management of severe knee osteoarthritis.Ethics and disseminationThe study received ethical approval from the West of Scotland REC 5 (Ref: 24/WS/0146) on 10 October 2024. Results will be disseminated through peer-reviewed publications.Trial registration numberISRCTN42984928.

ObjectivesPatient and healthcare professional perspectives are needed to develop a gender-affirming care patient-reported outcome measure (PROM) implementation plan. We aimed to identify top considerations relevant to gender-affirming care PROM implementation from patient and healthcare professional perspectives.Design, settings and participantsThis qualitative study conducted in the UK between January and April 2023 includes focus groups with a patient sample diverse in age and gender identity, and a healthcare professional sample diverse in age and role. Established methods in implementation science and the Consolidated Framework for Implementation Research were used to create interview guides, and analyse data. Focus groups were audio recorded, transcribed verbatim and analysed by two independent researchers. Patient and healthcare professional focus groups were conducted separately.Primary outcome measuresPatient and healthcare professional perspectives on PROM implementation were explored through focus groups and until data saturation.ResultsA total of 7 virtual focus groups were conducted with 24 participants (14 patients, mean (SD) age, 43 (14.5); 10 healthcare professionals, mean (SD) age, 46 (11.3)). From patient perspectives, key barriers to PROM implementation were mistrust with PROMs, lack of accessibility, burden, and lack of communication on why PROMs are important and how they will help care. From healthcare professional perspectives, key barriers to PROM implementation were lack of accessibility, burden with PROM administration and scoring, costs of implementation (financial and time), and lack of communication on what PROMs are and how they benefit service provision.ConclusionGender-affirming care PROM implementation must address: patient mistrust with PROMs, accessibility, communication on what PROMs are and how they can be used, reducing burden, and hybridised implementation. These factors may also be applicable to other clinical areas interested in implementing PROMs.

ObjectiveAssess acceptability, appropriateness and feasibility of the Practical Guide to Implementing patient-reported outcome measures (PROMs) in Gender-Affirming Care (PG-PROM-GAC) from a sample of patients and healthcare professionals.DesignCross-sectional study conducted August–October 2023.SettingParticipants were recruited from a National Health Service (NHS) gender clinic.ParticipantsPatient participants seeking care and healthcare professionals working at an NHS gender clinic were eligible for participation. The PG-PROM-GAC was sent to participants via email for review.Outcome measuresThree validated tools to measure acceptability, appropriateness and feasibility were administered: the acceptability of intervention measure (AIM), intervention appropriateness measure (IAM) and feasibility of intervention measure (FIM). The percentage of participants indicating agreement or disagreement with items on the AIM, IAM and FIM was calculated.ResultsA total of 132 transgender and gender diverse (TGD) patients (mean age, SD: 33, 14) and 13 gender-affirming healthcare professionals (mean age, SD: 43, 11) completed the AIM, IAM and FIM, representing a range of gender identities. The cumulative percentage of patients indicating agree or strongly agree on the AIM, IAM and FIM for the patient-relevant strategies in the PG-PROM-GAC was over 50% for each item. The cumulative percentage of patients indicating disagree or strongly disagree on the AIM, IAM and FIM for the PG-PROM-GAC was less than 20% for each item. The cumulative percentage of healthcare professionals indicating agree or strongly agree on the AIM, IAM and FIM for the healthcare professional-relevant strategies in the PG-PROM-GAC was over 38% for each item. The cumulative percentage of healthcare professionals indicating disagree or strongly disagree on the AIM, IAM and FIM for the PG-PROM-GAC was less than 15% for each item.ConclusionsGender-affirming healthcare professionals and TGD patients find the PG-PROM-GAC acceptable, appropriate and feasible. The PG-PROM-GAC is ready-to-use for clinicians, policy-makers and researchers committed to service improvement for gender-affirming care.

ImportanceSeveral international calls have been made for evidence-based patient-reported outcome measure (PROM) implementation for gender-affirming care. The Practical Guide to Implementing PROMs in Gender-Affirming Care (PG-PROM-GAC) is a resource which can help guide PROM implementation efforts, developed using a three-phase participatory research approach with transgender and gender-diverse (TGD) patients and gender-affirming healthcare professionals. However, thoughts and perspectives from TGD patients and gender-affirming healthcare professionals on the PG-PROM-GAC need to be investigated.ObjectiveInvestigate patient and healthcare professional perspectives on the PG-PROM-GAC through analysis of open-ended survey results.DesignQualitative study analysing open-ended responses from TGD patients and gender-affirming healthcare professionals.SettingParticipants were recruited from a UK National Health System (NHS) gender clinic.ParticipantsPatients receiving care at an NHS gender clinic and healthcare professionals working at an NHS gender clinic were eligible for participation. Eligible participants were invited to participate in this study via email.InterventionParticipants were sent an open-ended survey to collect responses on the PG-PROM-GAC.Main outcome(s) and measure(s)Data were thematically analysed by two independent researchers and interpreted following guidance from established methods in implementation science.ResultsA total of 64 TGD patients and 9 gender-affirming healthcare professionals responded to the open-ended survey (mean (SD) age: 35 (16) and 48 (8), respectively). Four main themes emerged from the data: overall opinions and support for the PG-PROM-GAC, presentation of the PG-PROM-GAC, impact of gender clinic resources on PROM implementation and impact of PROM selection on implementation. Data were used to iterate the PG-PROM-GAC in response to participant feedback.Conclusions and relevanceThe PG-PROM-GAC is an acceptable and feasible resource that can be used by clinicians, researchers and policymakers to guide PROM implementation for gender-affirming care settings, helping to align gender-affirming care with patient needs.