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OBJECTIVE: 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 optimise for ongoing use. STUDY DESIGN AND SETTING: Participants undergoing primary total knee replacement (TKR) provided pre-operative and post-operative responses for OKS and OKS-APQ. Confirmatory factor analyses (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. RESULTS: 2972 individual response patterns were analysed. 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. CONCLUSIONS: 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.

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This study aimed to analyse and contrast changes in health-related quality of life (HR-QoL) and hand symptoms in the first 6 months after surgical treatment for primary cubital tunnel syndrome. Data originated from the United Kingdom Hand Registry. HR-QoL was assessed using the generic EuroQol five-dimensional assessment tool (EQ-5D-5L) and hand symptoms using the Patient Evaluation Measure (PEM). In total, 281 patients were included in the statistical analysis. Cubital tunnel release resulted in clinically relevant relief of hand symptoms. However, no improvement in HR-QoL was detected by the EQ-5D-5L. As a result, current health economic models, such as those used by the National Institute for Health Care Excellence (NICE) in the UK, might conclude that cubital tunnel release is not cost-effective. This discrepancy requires exploration, and hand-specific preference-based measures might be needed for value-based healthcare in hand surgery.Level of evidence: III.

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Background: Free tissue transfer (FTT) for reconstruction of diabetic foot disease (DFD) is an emerging field to preserve the lower limb within this patient group. The design of future quantitative research and clinical services in this area must consider the needs, expectations and concerns of patients. This qualitative study explores patient experiences of FTT for reconstruction of DFD. Methods: Semistructured interviews were conducted to explore patients' lived experiences of FTT for DFD. A purposive sampling strategy identified six patients who underwent FTT for recalcitrant DFD between September 2019 and December 2021 in a single center in the United Kingdom. Results: Three experiential themes emerged. Theme 1: "negative lived experiences of living with DFD" included frustration with the chronic management of nonhealing ulcers and fear regarding limb amputation. Theme 2: "surgery related concerns" included fears of reconstructive failure and subsequent amputation, as well as foot cosmesis and donor-site morbidity. Theme 3: "positive lived experiences following reconstruction" included the positive impact the reconstruction had on their overall life and diabetic control. All patients would repeat the process to obtain their current results. Conclusions: This qualitative study provides first-hand insight into the lived experience of FTT for DFD, exploring both the negative and positive experiences and reasons for these. We found that FTT for DFD can be positively life-changing for affected individuals.

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Background: Facial skin cancer and its surgical treatment can affect health-related quality of life. The FACE-Q Skin Cancer Module is a patient-reported outcome measure that measures different aspects of health-related quality of life and has recently been translated into Dutch. This study aimed to evaluate the performance of the translated version in a Dutch cohort using modern psychometric measurement theory (Rasch). Methods: Dutch participants with facial skin cancer were prospectively recruited and asked to complete the translated FACE-Q Skin Cancer Module. The following assumptions of the Rasch model were tested: unidimensionality, local independence, and monotonicity. Response thresholds, fit statistics, internal consistency, floor and ceiling effects, and targeting were assessed for all scales and items within the scales. Responsiveness was tested for the "cancer worry" scale. Results: In total, 259 patients completed the preoperative questionnaire and were included in the analysis. All five scales assessed showed a good or sufficient fit to the Rasch model. Unidimensionality and monotonicity were present for all scales. Some items showed a local dependency. Most of the scales demonstrate ordered item thresholds and appropriate fit statistics. Conclusions: The FACE-Q Skin Cancer Module is a well-designed patient-reported outcome measure that shows psychometric validity for the translated version in a Dutch cohort, using classical and modern test theory.

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Aims: Hand trauma, consisting of injuries to both the hand and the wrist, are a common injury seen worldwide. The global age-standardized incidence of hand trauma exceeds 179 per 100,000. Hand trauma may require surgical management and therefore result in significant costs to both healthcare systems and society. Surgical site infections (SSIs) are common following all surgical interventions, and within hand surgery the risk of SSI is at least 5%. SSI following hand trauma surgery results in significant costs to healthcare systems with estimations of over £450 per patient. The World Health Organization (WHO) have produced international guidelines to help prevent SSIs. However, it is unclear what variability exists in the adherence to these guidelines within hand trauma. The aim is to assess compliance to the WHO global guidelines in prevention of SSI in hand trauma. Methods: This will be an international, multicentre audit comparing antimicrobial practices in hand trauma to the standards outlined by WHO. Through the Reconstructive Surgery Trials Network (RSTN), hand surgeons across the globe will be invited to participate in the study. Consultant surgeons/associate specialists managing hand trauma and members of the multidisciplinary team will be identified at participating sites. Teams will be asked to collect data prospectively on a minimum of 20 consecutive patients. The audit will run for eight months. Data collected will include injury details, initial management, hand trauma team management, operation details, postoperative care, and antimicrobial techniques used throughout. Adherence to WHO global guidelines for SSI will be summarized using descriptive statistics across each criteria. Discussion: The Hand and Wrist trauma: Antimicrobials and Infection Audit of Clinical Practice (HAWAII ACP) will provide an understanding of the current antimicrobial practice in hand trauma surgery. This will then provide a basis to guide further research in the field. The findings of this study will be disseminated via conference presentations and a peer-reviewed publication.

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BACKGROUND: Health state utility values provide the quality component of quality-adjusted life years and are essential for health economic analyses, such as the National Institute for Health and Care Excellence Technology Appraisal. The aims of this systematic review were to: catalogue utility values for health states experienced by patients with hand conditions; provide pooled utility estimates for common hand conditions; and determine how utilities have been estimated. METHODS: A PRISMA-compliant systematic review and meta-analysis was conducted (registered in PROSPERO, the international prospective register of systematic reviews (CRD42021226098)). Five databases were searched from inception until April 2023 (Embase, MEDLINE, PsycINFO, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), and the Cochrane Central Register of Controlled Trials (CENTRAL)). All studies that reported primary utility values for hand health states in adult patients were eligible for inclusion. Pooled utility estimates were determined across conditions and intervention status using random-effects meta-analysis. RESULTS: A total of 10 254 articles were identified; 57 studies met the full inclusion criteria and reported 363 distinct health state utility values. Health state utility values were estimated using a range of methods; the most common measure was the EQ-5D. Pooled utility estimates for carpal tunnel syndrome and hand osteoarthritis before surgical intervention were 0.69 (95% c.i. 0.66 to 0.73) and 0.63 (95% c.i. 0.60 to 0.67) respectively. CONCLUSION: Pooled utility estimates for patients with untreated carpal tunnel syndrome and hand osteoarthritis are 11% and 18% lower than age-matched population norms respectively. Hand conditions have a significant detrimental impact on health-related quality of life and this study provides catalogued utility values for use in future economic analyses to support the delivery of value-based hand surgery.

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BACKGROUND: The Forgotten Joint Score (FJS), a commonly used patient-reported outcome measure, was developed without fully confirming assumptions such as unidimensionality (all items reflect 1 underlying factor), appropriate weighting of each item in scoring, absence of differential item functioning (in which different groups, e.g., men and women, respond differently), local dependence (pairs of items are measuring only 1 underlying factor), and monotonicity (persons with higher function have a higher score). We applied item response theory (IRT) to perform validation of the FJS according to contemporary standards, and thus support its ongoing use. We aimed to confirm that the FJS reflects a single latent trait. In addition, we aimed to determine whether an IRT model could be fitted to the FJS. METHODS: Participants undergoing primary total knee replacement provided responses to the FJS items preoperatively and at 6 and 12 months postoperatively. An exploratory factor analysis (EFA), confirmatory factor analysis (CFA), and Mokken analysis were conducted. A graded response model (GRM) was fitted to the data. RESULTS: A total of 1,774 patient responses were analyzed. EFA indicated a 1-factor model (all 12 items reflecting 1 underlying trait). CFA demonstrated an excellent model fit. Items did not have equal weighting. The FJS demonstrated good monotonicity and no differential item functioning by sex, age, or body mass index. GRM parameters are reported in this paper. CONCLUSIONS: The FJS meets key validity assumptions, supporting its use in clinical practice and research. The IRT-adapted FJS has potential advantages over the traditional FJS: it provides continuous measurements with finer granularity between health states, includes individual measurement error, and can compute scores despite more missing data (with only 1 response required to estimate a score). It can be applied retrospectively to existing data sets or used to deliver individualized computerized adaptive tests. LEVEL OF EVIDENCE: Prognostic Level II . See Instructions for Authors for a complete description of levels of evidence.

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Aims: The Manchester-Oxford Foot Questionnaire (MOxFQ) is an anatomically specific patient-reported outcome measure (PROM) currently used to assess a wide variety of foot and ankle pathology. It consists of 16 items across three subscales measuring distinct but related traits: walking/standing ability, pain, and social interaction. It is the most used foot and ankle PROM in the UK. Initial MOxFQ validation involved analysis of 100 individuals undergoing hallux valgus surgery. This project aimed to establish whether an individual's response to the MOxFQ varies with anatomical region of disease (measurement invariance), and to explore structural validity of the factor structure (subscale items) of the MOxFQ. Methods: This was a single-centre, prospective cohort study involving 6,637 patients (mean age 52 years (SD 17.79)) presenting with a wide range of foot and ankle pathologies between January 2013 and December 2021. To assess whether the MOxFQ responses vary by anatomical region of foot and ankle disease, we performed multigroup confirmatory factor analysis. To assess the structural validity of the subscale items, exploratory and confirmatory factor analyses were performed. Results: Measurement invariance by pathology was confirmed, suggesting the same model can be used across all foot and ankle anatomical regions. Exploratory factor analysis demonstrated a two- to three-factor model, and suggested that item 13 (inability to carry out work/everyday activities) and item 14 (inability to undertake social/recreational activities) loaded more positively onto the "walking/standing" subscale than their original "social interaction" subscale. Conclusion: This large cohort study supports the current widespread use of the MOxFQ across a broad range of foot and ankle pathologies. Our analyses found indications that could support alterations to the original factor structure (items 13 and 14 might be moved from the "social interaction" to the "walking/standing" subscale). However, this requires further work to confirm.

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Background: Rasch measurement theory can be used to identify scales within questionnaires and to map responses to more precise continuous scales. The aim of this article was to use RMT to refine the scoring of the QuickDASH in patients with Dupuytren disease and carpal tunnel syndrome (CTS). Methods: Data were collected between 2013 and 2019 from a single center in the UK. Preoperative QuickDASH responses from patients diagnosed with Dupuytren disease and CTS were used. RMT was used to reduce the number of items in the QuickDASH and examine the reliability and validity of each subscale. Results: The preoperative QuickDASH responses of 750 patients with Dupuytren disease and 1916 patients with CTS were used. The median age of participants was 61 years, and 46% were men. Exploratory factor analysis suggested two distinct subscales within the QuickDASH: task items 1-6 and symptom items 9-11. These items were fitted to the Rasch model, and disordered response thresholds were collapsed. In Dupuytren disease, the two worst responses or each item were disordered. After collapsing these options, good Rasch model fit was demonstrated. CTS responses fitted without modification. Item targeting was more appropriate for CTS than Dupuytren disease. Conclusions: This study proposes a modification to the scoring system for the QuickDASH that provides high-quality, continuous, and condition-specific scales for the QuickDASH. The identification of distinct subscales within the QuickDASH can be used to identify distinct improvements in hand function and/or symptoms in previous, current, and future work.

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Aims: To map the Oxford Knee Score (OKS) and High Activity Arthroplasty Score (HAAS) items to a common scale, and to investigate the psychometric properties of this new scale for the measurement of knee health. Methods: Patient-reported outcome measure (PROM) data measuring knee health were obtained from the NHS PROMs dataset and Total or Partial Knee Arthroplasty Trial (TOPKAT). Assumptions for common scale modelling were tested. A graded response model (fitted to OKS item responses in the NHS PROMs dataset) was used as an anchor to calibrate paired HAAS items from the TOPKAT dataset. Information curves for the combined OKS-HAAS model were plotted. Bland-Altman analysis was used to compare common scale scores derived from OKS and HAAS items. A conversion table was developed to map between HAAS, OKS, and the common scale. Results: We included 3,329 response sets from 528 patients undergoing knee arthroplasty. These generally met the assumptions of unidimensionality, monotonicity, local independence, and measurement invariance. The HAAS items provided more information than OKS items at high levels of knee health. Combining both instruments resulted in higher test-level information than either instrument alone. The mean error between common scale scores derived from the OKS and HAAS was 0.29 logits. Conclusion: The common scale allowed more precise measurement of knee health than use of either the OKS or HAAS individually. These techniques for mapping PROM instruments may be useful for the standardization of outcome reporting, and pooling results across studies that use either PROM in individual-patient meta-analysis.

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OBJECTIVES: Demonstrate psychometric sensitivity analyses for testing the stability of study findings to assumptions made about patient-reported outcome measures. STUDY DESIGN AND SETTING: 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. RESULTS: 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. CONCLUSIONS: Psychometric sensitivity analyses aid in the interpretation of the Prevention of Shoulder Problems trial's results.

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Background: The incidence of incisional self-harm of the upper limbs is increasing, and recurrence rates are high. It is not known whether different wound treatment strategies (dressings only vs. surgery) or the operative setting (main theatre vs. non-main theatre) affect wound or mental health-related outcomes. Methods: Four electronic databases (Ovid MEDLINE, OVID EMBASE, PsycINFO and CENTRAL) were searched from inception to 14/09/2021 for studies which describe the management of incisional self-harm wounds of the upper limb(s) in adults and children. Dual-author screening and data extraction were conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. Results: In total, 19 studies (1477 patients) were included. Overall, the evidence was limited by a paucity of comparative data on wound management strategy and setting, and poor-quality outcome reporting. Only four studies clearly identified the operative setting for definitive wound management (two in main operating theatres, one in the emergency department and one using both settings, depending on injury severity). Few studies inconsistently reported surgical outcomes (n=9) or mental health outcomes (n=4), hindering evidence synthesis. Conclusion: Further investigation is needed to determine the most cost-effective management strategies and settings for these injuries.

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In outcome measures, item response theory (IRT) validation can deliver interval-scaled high-quality measurement that can be harnessed using computerized adaptive tests (CATs) to pose fewer questions to patients. We aimed to develop a CAT by developing an IRT model for the Patient Evaluation Measure (PEM) for patients undergoing cubital tunnel syndrome (CuTS) surgery. Nine hundred and seventy-nine completed PEM responses of patients with CuTS in the United Kingdom Hand Registry were used to develop and calibrate the CAT. Its performance was then evaluated in a simulated cohort of 1000 patients. The CAT reduced the original PEM length from ten to a median of two questions (range two to four), while preserving a high level of precision (median standard error of measurement of 0.27). The mean error between the CAT score and full-length score was 0.08%. A Bland-Altman analysis showed good agreement with no signs of bias. The CAT version of the PEM can substantially reduce patient burden while enhancing construct validity by harnessing IRT for patients undergoing CuTS surgery.

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OBJECTIVES: 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. STUDY DESIGN AND SETTING: 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. RESULTS: 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. CONCLUSION: 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.

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OBJECTIVES: To apply item response theory as a framework for studying measurement error in superiority trials which use patient-reported outcome measures (PROMs). METHODS: 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. RESULTS: 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. CONCLUSION: Psychometric sensitivity analyses can be readily performed for superiority trials using PROMs and may aid the interpretation of results.

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STUDY DESIGN: Retrospective cohort. BACKGROUND: The QuickDASH is a commonly used questionnaire for the assessment of carpal tunnel patients, although it is unclear whether the questionnaire has suitable structural validity PURPOSE: This study aimed to evaluate the structural validity of the QuickDASH patient-reported outcome measure (PROM), when used in CTS, through exploratory factor analysis (EFA) and structural equation modelling (SEM). METHODS: Between 2013 and 2019, we recorded preoperative QuickDASH scores of 1916 patients undergoing carpal tunnel decompressions at a single unit. One hundred and eighteen patients with incomplete datasets were excluded leaving a final study group of 1798 patients with complete data. EFA was undertaken using the R statistical computing environment. We then conducted SEM in a random sample of 200 patients. Model fit was assessed using the chi-square (χ2) test, comparative fit index (CFI), Tucker-Lewis index (TLI), root mean square error of approximation (RMSEA) and standardized root mean square residuals (SRMR). A second "validation" SEM analysis was undertaken by repeating the analysis with a separate sample of 200 randomly-selected patients. RESULTS: EFA revealed a 2-factor model: items 1-6 represented the first factor ("function") and items 9-11 measured a different factor ("symptoms"). SEM demonstrated excellent fit (χ2 p value 0.167, CFI 0.999, TLI 0.999, RMSEA 0.032, SRMR 0.046) and this was supported in our "validation" sample. CONCLUSIONS: This study demonstrates that the QuickDASH PROM measures 2 distinct factors in CTS. This is comparable with the findings of a previous EFA that assessed the full-length Disabilities of the Arm, Shoulder and Hand PROM in patients with Dupuytren's disease.

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STUDY DESIGN: Retrospective cohort BACKGROUND: Exploratory Factor Analysis (EFA) and structural equation modelling (SEM) assess relationships between questionnaire items and the constructs ("factors") measured by a questionnaire. The QuickDASH has not been subjected to these analyses in Dupuytren's disease. PURPOSE: To undertake EFA and SEM to identify the factors measured by the QuickDASH in patients with Dupuytren's disease. METHODS: We identified 750 cases of surgery for Dupuytren's disease at a single center with preoperative QuickDASH scores. We performed EFA on QuickDASH responses in R, using established methodology. Based on the EFA results, we conducted SEM in a training sample of 200 participants. A test SEM analysis was performed in a second, independent sample of 200 participants. RESULTS: EFA suggested a 2-factor model. Items 1-6 measured one factor (we interpreted this as "hand function"), whereas items 9-11 measured a different factor ("hand symptoms"). Items 7 and 8 (social and work activities) did not reflect either of these factors well, and may be influenced by other variables. A structural equation model based on the EFA results, with 2 first-order factors, demonstrated excellent fit in our first SEM sample. This was confirmed with a second independent sample in a test analysis. CONCLUSIONS: The QuickDASH PROM may measure 2 distinct factors in patients with Dupuytren's disease. This aligns with previous analyses of the full-length DASH PROM. Separation of the QuickDASH PROM into 2 sub-scales with distinct scores to measure "hand function" and "hand symptoms" may improve its structural validity in patients with Dupuytren's disease.

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Hidradenitis suppurativa (HS) is a chronic inflammatory skin condition characterized by suppurative infection, sinus tract, and abscess formation. International management guidelines are largely consensus-based. Botulinum toxin (BTX) has been widely used in the treatment of apocrine and eccrine gland disorders, such as hyperhidrosis, although the effectiveness of BTX in the treatment of HS remains unknown. The aim of this systematic review was to understand the published evidence of BTX safety and effectiveness in the management of HS. Methods: We conducted a PRISMA-compliant, prospectively registered (PROSPERO, CRD42021228732), systematic review. We devised bespoke search strategy and applied it to the Cochrane Central Register of Controlled Trials, Medline, Embase, and OpenGrey up until March 2022. We included all clinical studies that reported outcomes following BTX treatment in patients diagnosed with HS (both adult and pediatric). Results: A total of 4658 studies were identified, of which six met full inclusion criteria reporting data on 26 patients. The six identified studies included one randomized control trial, one case series, and four case studies. The one included randomized control trial demonstrated a significant reduction in the Dermatology Life Quality Index score at 3 months following treatment with BTX. Conclusions: The effectiveness and safety of BTX in the treatment of HS remain unknown. This systematic review identified a paucity of high-quality clinical data. Evidence of treatment effectiveness is likely to come from registry-based cohort studies using established core outcome sets in the first instance.