Remote postoperative management using Ecological Momentary Computerized Adaptive Testing (EMCAT): feasibility assessment survey.

Our survey of 38 surgeons shows that Ecological Momentary Computerized Adaptive Testing (EMCAT), a platform to remotely collect patient-reported outcome measures (PROMs) is acceptable to surgeons, and 36 of 38 are willing to participate in future randomized control trials comparing EMCAT versus routine follow-up.Level of evidence: IV.

Changes in hand function and health state utility after cubital tunnel release using the United Kingdom Hand Registry.

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.

Item response theory validation of the Oxford Knee Score and Activity and Participation Questionnaire: a step towards a common metric.

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.

FACE-Q for Measuring Patient-reported Outcomes after Facial Skin Cancer Surgery: Cross-cultural Validation.

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.

A Qualitative Study of Patients' Lived Experiences of Free Tissue Transfer for Diabetic Foot Disease.

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.

Health-related quality of life in patients with conditions affecting the hand: meta-analysis.

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.

Hand and Wrist trauma: Antimicrobials and Infection Audit of Clinical Practice (HAWAII ACP) protocol.

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.

Item Response Theory Validation of the Forgotten Joint Score for Persons Undergoing Total Knee Replacement.

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.

Structural validation of the Manchester-Oxford Foot Questionnaire for use in foot and ankle surgery.

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.

Modified Scoring of the QuickDASH Can Achieve Previously-unattained Interval-level Measurement in Dupuytren Disease and Carpal Tunnel Syndrome.

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.

Remote Symptom Monitoring With Ecological Momentary Computerized Adaptive Testing: Pilot Cohort Study of a Platform for Frequent, Low-Burden, and Personalized Patient-Reported Outcome Measures.

BACKGROUND: 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. OBJECTIVE: The aim of this study is to determine the feasibility of EMCAT as a system for remote PROM administration. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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. TRIAL REGISTRATION: ISRCTN 19841416; https://www.isrctn.com/ISRCTN19841416.

Psychometric sensitivity analyses can identify bias related to measurement properties in trials that use patient-reported outcome measures: a secondary analysis of a clinical trial using the disabilities of the arm, shoulder, and hand questionnaire.

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.

Statistics for the hand surgeon. Part 1: principles and application to hand surgery research.

Hand surgeons have the potential to improve patient care, both with their own research and by using evidenced-based practice. In this first part of a two-part article, we describe key steps for the analysis of clinical data using quantitative methodology. We aim to describe the principles of medical statistics and their relevance and use in hand surgery, with contemporaneous examples. Hand surgeons seek expertise and guidance in the clinical domain to improve their practice and patient care. Part of this process involves the critical analysis and appraisal of the research of others.

Statistics for the hand surgeon. Part 2: avoiding common pitfalls.

In this second of a two-part article, we describe some of the common statistical pitfalls encountered in hand surgery research. These include dichotomania, the 'Table 2 fallacy', p-hacking, regression to the mean, overfitting and unaccounted data clustering. We explain the impact of these pitfalls on hand surgery research and describe techniques to avoid them. The aim of this two-part article was to provide a starting point for hand surgeons to refer to when conducting or analysing research and provide resources and references for interested readers to explore.

Management of Incisional Self-Harm of the Upper Limb: A Systematic Review.

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.

Computerized adaptive testing for the patient evaluation measure (PEM) in patients undergoing cubital tunnel syndrome surgery.

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.

The Development, Deployment, and Evaluation of the CLEFT-Q Computerized Adaptive Test: A Multimethods Approach Contributing to Personalized, Person-Centered Health Assessments in Plastic Surgery.

BACKGROUND: Routine use of patient-reported outcome measures (PROMs) and computerized adaptive tests (CATs) may improve care in a range of surgical conditions. However, most available CATs are neither condition-specific nor coproduced with patients and lack clinically relevant score interpretation. Recently, a PROM called the CLEFT-Q has been developed for use in the treatment of cleft lip or palate (CL/P), but the assessment burden may be limiting its uptake into clinical practice. OBJECTIVE: We aimed to develop a CAT for the CLEFT-Q, which could facilitate the uptake of the CLEFT-Q PROM internationally. We aimed to conduct this work with a novel patient-centered approach and make source code available as an open-source framework for CAT development in other surgical conditions. METHODS: CATs were developed with the Rasch measurement theory, using full-length CLEFT-Q responses collected during the CLEFT-Q field test (this included 2434 patients across 12 countries). These algorithms were validated in Monte Carlo simulations involving full-length CLEFT-Q responses collected from 536 patients. In these simulations, the CAT algorithms approximated full-length CLEFT-Q scores iteratively, using progressively fewer items from the full-length PROM. Agreement between full-length CLEFT-Q score and CAT score at different assessment lengths was measured using the Pearson correlation coefficient, root-mean-square error (RMSE), and 95% limits of agreement. CAT settings, including the number of items to be included in the final assessments, were determined in a multistakeholder workshop that included patients and health care professionals. A user interface was developed for the platform, and it was prospectively piloted in the United Kingdom and the Netherlands. Interviews were conducted with 6 patients and 4 clinicians to explore end-user experience. RESULTS: The length of all 8 CLEFT-Q scales in the International Consortium for Health Outcomes Measurement (ICHOM) Standard Set combined was reduced from 76 to 59 items, and at this length, CAT assessments reproduced full-length CLEFT-Q scores accurately (with correlations between full-length CLEFT-Q score and CAT score exceeding 0.97, and the RMSE ranging from 2 to 5 out of 100). Workshop stakeholders considered this the optimal balance between accuracy and assessment burden. The platform was perceived to improve clinical communication and facilitate shared decision-making. CONCLUSIONS: Our platform is likely to facilitate routine CLEFT-Q uptake, and this may have a positive impact on clinical care. Our free source code enables other researchers to rapidly and economically reproduce this work for other PROMs.

QuickDASH questionnaire items behave as 2 distinct subscales rather than one scale in Dupuytren's disease.

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.