Outcomes Research Research Articles

Translation and Cross-Cultural Adaptation into French of the Harris Hip Score and the Modified Harris Hip Score.

The objective of this study was to develop a cross-cultural adaptation and translation into French of the original Harris Hip Score (HHS) and the modified Harris Hip Score (mHHS). The translation and cultural-adaptation of the questionnaire were performed following a 10-step process as recommended by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR). During the cognitive debriefing, each item of the questionnaire has been rated between 1 and 10 according to the comprehension level of 8 patients who underwent total hip arthroplasty. The cross-cultural adaptation process required the modification of the walking distance item by converting the number of blocks into meters but also in walking time (minutes). All the different steps have been performed without any other important changes on the translated questionnaire which has been found highly understandable by interviewed patients (9.6 ± 1.1). This study successfully reports the French version development of the original HHS (HHS-Fr) and its modified patient-reported version (mHHS-Fr), thereby providing to clinicians a standardised version for the evaluation of French-speaking patients suffering from hip osteoarthritis.

An Overview of the Methodology Used to Develop Clinical Practice Guidelines for the Management of Acute and Intraoperative Spinal Cord Injury.

An overview of the methods used to develop clinical practice guidelines (CPGs). Acute spinal cord injury (SCI) and intraoperative SCI (ISCI) can have devastating physical and psychological consequences for patients and their families. To date, there are several studies that have discussed the diagnostic and management strategies for both SCI and ISCI. CPGs in SCI help to distill and translate the current evidence into actionable recommendations, standardize care across centers, optimize patient outcomes, and reduce costs and unnecessary interventions. Furthermore, they can be used by patients to assist in making decisions about certain treatments and by policy makers to inform allocation of resources. The objective of this article is to summarize the methods used to develop CPGs for the timing of surgery and hemodynamic management of acute SCI, as well as the identification and treatment of ISCI. The CPGs were developed using standards established by the Institute of Medicine (now the National Academy of Medicine), the Guideline International Network and several other organizations. Systematic reviews were conducted according to accepted methodological standards (eg, Institute of Medicine, Agency for Healthcare Research and Quality and Patient-Centered Outcomes Research Institute) in order to summarize the current body of evidence and inform the guideline development process. Protocols for each guideline were created. A multidisciplinary guideline development group (GDG) was formed that included individuals living with SCI as well as clinicians from the broad range of specialties that encounter patients with SCI: spine or trauma surgeons, critical care physicians, rehabilitation specialists, neurologists, anesthesiologists and other healthcare professionals. Individuals living with SCI were also included in the GDG. The Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach was used to rate the certainty of the evidence for each critical outcome. The "evidence to recommendation" framework was then used to translate the evidence obtained from the systematic review to an actionable recommendation. This framework provides structure when assessing the body of evidence and considers several additional factors when rating the strength of the recommendation, including the magnitude of benefits and harms, patient preferences, resource use, health equities, acceptability and feasibility. Finally, the CPGs were appraised both internally and externally. The results of the CPGs for SCI are provided in separate articles in this focus issue. Development of these CPGs for SCI followed the methodology proposed by the Institute of Medicine the Guideline International Network and the GRADE Working Group. It is anticipated that these CPGs will assist clinicians implement the best evidence into practice and facilitate shared-decision making with patients.

Raising the Bar for Real-World Data in Oncology: Approaches to Quality Across Multiple Dimensions.

Electronic health record (EHR)-based real-world data (RWD) are integral to oncology research, and understanding fitness for use is critical for data users. Complexity of data sources and curation methods necessitate transparency into how quality is approached. We describe the application of data quality dimensions in curating EHR-derived oncology RWD. A targeted review was conducted to summarize data quality dimensions in frameworks published by the European Medicines Agency, The National Institute for Healthcare and Excellence, US Food and Drug Administration, Duke-Margolis Center for Health Policy, and Patient-Centered Outcomes Research Institute. We then characterized quality processes applied to curation of Flatiron Health RWD, which originate from EHRs of a nationwide network of academic and community cancer clinics, across the summarized quality dimensions. The primary quality dimensions across frameworks were relevance (including subdimensions of availability, sufficiency, and representativeness) and reliability (including subdimensions of accuracy, completeness, provenance, and timeliness). Flatiron Health RWD quality processes were aligned to each dimension. Relevancy to broad or specific use cases is optimized through data set size and variable breadth and depth. Accuracy is addressed using validation approaches, such as comparison with external or internal reference standards or indirect benchmarking, and verification checks for conformance, consistency, and plausibility, selected on the basis of feasibility and criticality of the variable to the intended use case. Completeness is assessed against expected source documentation; provenance by recording data transformation, management procedures, and auditable metadata; and timeliness by setting refresh frequency to minimize data lags. Development of high-quality, scaled, EHR-based RWD requires integration of systematic processes across the data lifecycle. Approaches to quality are optimized through knowledge of data sources, curation processes, and use case needs. By addressing quality dimensions from published frameworks, Flatiron Health RWD enable transparency in determining fitness for real-world evidence generation.

Differences in the surgical management of degenerative lumbar spondylolisthesis based on self-reported sex: analysis of the CSORN prospective DLS study.

Surgical treatment of degenerative lumbar spondylolisthesis (DLS) reliably improves patient-reported quality of life; however, patient population heterogeneity, in addition to other factors, ensures ongoing equipoise in choosing the ideal surgical treatment. Surgeon preference for fusion or decompression alone influences surgical treatment decision-making. Meanwhile, at presentation, patient-reported outcome measures (PROMs) differ considerably between females and males. The aims of this study were to determine whether there exists a difference in the rates of decompression and fusion versus decompression alone based on patient-reported sex, and to determine if widely accepted indications for fusion justify any observed differences or if surgeon preference plays a role. This study is a retrospective cohort analysis of patients enrolled in the Canadian Spine Outcomes Research Network (CSORN) DLS study, a multicentered Canadian prospective study, investigating the surgical management and outcome of DLS. Decompression and fusion rates, patient characteristics, preoperative PROMs, and radiographic measures were compared between males and females before and after propensity score matching. In the unmatched cohort, female patients were more likely to undergo decompression and fusion than male patients. Females were more likely to have the recognized indications for fusion, including kyphotic disc angle, higher spondylolisthesis grade and slip percentage, and patient-reported back pain. Other radiographic findings associated with the decision to fuse, including facet effusion, facet distraction, or facet angle, were not more prevalent in females. After propensity score matching for demographic and radiographic characteristics, similar proportions of male and female patients underwent decompression and fusion and decompression alone. Although it remains unclear who should or should not undergo fusion, in addition to surgical decompression of DLS, female patients undergo fusion at a higher rate than their male counterparts. After matching baseline radiographic factors indicating fusion, this analysis showed that the decision to fuse was not biased by sex differences. Rather, the higher proportion of females undergoing fusion is largely explained by the radiographic and clinical indications for fusion, suggesting that specific clinical and anatomical features of this condition are indeed different between sexes.

Comparative effectiveness of azathioprine and mycophenolate mofetil for myasthenia gravis (PROMISE-MG): a prospective cohort study

Myasthenia gravis is an autoimmune disorder of the neuromuscular junction. Treatment typically includes symptomatic oral cholinesterase inhibitors, immunosuppression, and immunomodulation. In addition to corticosteroids, azathioprine and mycophenolate mofetil are the most frequently used immunosuppressants in North America. We aimed to evaluate the comparative effectiveness of these two drugs, and to assess the effect of the dose and duration of treatment. We did a prospective cohort study at 19 academic centres in Canada and the USA. We included patients (aged ≥18 years) with autoimmune myasthenia gravis, who were never treated with immunosuppressants. Treating clinicians determined the choice of medication, dose, follow-up intervals, and drug monitoring. Outcome measures and adverse events were recorded at each visit. We assessed two co-primary outcomes. The first was the patient-reported Myasthenia Gravis-Quality of Life 15-revised (MGQOL-15r) score, measured as the mean change from treatment initiation to the follow-up visit with the lowest score. A clinically meaningful reduction (CMR) in MGQOL-15r was defined as a 5-point decrease. The second was a composite clinical outcome of disease improvement (Myasthenia Gravis Foundation of America Post-Intervention Status Minimal Manifestations or better) and low adverse event burden (defined as grade ≤1 Common Terminology Criteria for Adverse Events). We also compared these outcomes in patients receiving an adequate dose and duration of azathioprine (≥2 mg/kg per day for at least 12 months) or mycophenolate mofetil (≥2 g per day for at least 8 months) and a lower dose or shorter duration of these agents. We used propensity score weighting with generalised linear regression models. This study is registered with ClinicalTrials.gov (NCT03490539). Between May 1, 2018, and Aug 31, 2020, 167 patients were enrolled; 85 did not receive azathioprine or mycophenolate mofetil and were excluded. Four were excluded from outcome analyses because they had scores of 0 on an outcome measure at treatment initiation. Of the 78 patients included in analyses, 47 received mycophenolate mofetil (median follow-up 25 months [IQR 13·5-31·5]) and 31 received azathioprine (median follow-up 20 months [IQR 13-30]). The mean change in MG-QOL15r was -10·4 (95% CI -18·9 to -1·3) with mycophenolate mofetil and -6·8 (-17·2 to 3·6) with azathioprine (mean difference -3·3, 95% CI -7·7 to 1·2; p=0·15). 38 (81%) of 47 patients receiving mycophenolate mofetil and 18 (57%) of 31 receiving azathioprine had a CMR in MG-QOL15r (risk difference 24·0%; 95% CI -0·2 to 48·0; p=0·052). The clinical composite outcome was achieved in 22 (47·7%) of 47 patients who received mycophenolate mofetil and nine (28·1%) of 31 who received azathioprine (risk difference 19·6%, 95% CI -4·9 to 44·2; p=0·12). Descriptive analysis did not find a difference in the proportion of patients reaching a CMR in MG-QOL15r between the adequate dose and duration group and the lower dose or shorter duration group. Adverse events occurred in 11 (32%) of 34 patients who received azathioprine and nine (19%) of 48 who received mycophenolate mofetil. The most frequent adverse events were hepatotoxicity with azathioprine (five [15%] of 34) and gastrointestinal disturbances (seven [15%] of 48) with mycophenolate mofetil. There were no study-related deaths. More than half of patients treated with azathioprine and mycophenolate mofetil felt their quality of life improved; no difference in clinical outcomes was noted between the two drugs. Adverse events associated with azathioprine were potentially more serious than those with mycophenolate mofetil, although mycophenolate mofetil is teratogenic. Lower than recommended doses of azathioprine might be effective, with reduced dose-dependent adverse events. More comparative effectiveness studies are required to inform treatment choices in myasthenia gravis. Patient-Centered Outcomes Research Institute, Myasthenia Gravis Foundation of America.

Harmonising linguistic validation with AI: Precision, efficiency, and the human touch in patient-reported outcome translation

The surge in artificial intelligence (AI) prompts a reassessment of linguistic validation methods for patient-reported outcome (PRO) measures. The robust linguistic process, designed to adapt PRO measures for different cultures and languages, is upheld by regulators and the outcomes research community for its value in maintaining concept equivalence across global trial data. Its methods are entrenched in human translation and review, making it more challenging to integrate AI (machine learning, deep learning, natural language processing) compared to other parts of the global localisation industry. This article provides an overview of the key challenges in integrating linguistic validation and AI. Despite these hurdles, it advocates for the industry to embrace the potential benefits through collaborative and responsible innovation.

Defining domains: developing consensus-based definitions for foundational domains in OMERACT core outcome sets

ObjectiveTo develop a set of detailed definitions for foundational domains commonly used in OMERACT (Outcome Measures in Rheumatology) core domain sets. MethodsWe identified candidate domain definitions from prior OMERACT publications and websites and publications of major organizations involved in outcomes research for six domains commonly used in OMERACT Core Domain Sets: pain intensity, pain interference, physical function, fatigue, patient global assessment, and health-related quality of life. We conducted a two-round survey of OMERACT working groups, patient research partners, and then the OMERACT Technical Advisory Group to establish their preferred domain definitions. Results were presented at the OMERACT 2023 Methodology Workshop, where participants discussed their relevant lived experience and identified potential sources of variability giving the needed detail in our domain definitions. ResultsOne-hundred four people responded to both rounds of the survey, and a preferred definition was established for each of the domains except for patient global assessment for which no agreement was reached. Seventy-five participants at the OMERACT 2023 Methodology Workshop provided lived experience examples, which were used to contextualise domain definition reports for each of the five domains. ConclusionUsing a consensus-based approach, we have created a detailed definition for five of the foundational domains in OMERACT core domain sets; patient global assessment requires further research. These definitions, although not mandatory for working groups to use, may facilitate the initial domain-match assessment step of instrument selection, and reduce the time and resources required by future OMERACT groups when developing core outcome sets.

Predictive Factors of Pain and Functional Outcome 5 Years Following Total Hip Arthroplasty: A Prospective Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement Cohort Study

BackgroundPrevious reports have identified a number of potential predictors of pain and function after total hip arthroplasty (THA). However, the results of these studies were conflicting, and most had a short follow-up after THA. The purpose of this study was to identify factors predictive of pain and function 5 years after THA. MethodsA multicenter cohort of 7,934 primary unilateral THA patients was prospectively enrolled in the Function and Outcomes Research for Comparative Effectiveness in Total Joint Replacement consortium. Demographic data, comorbidities, and patient-reported outcome measures were collected preoperatively and postoperatively at 5 years, including the Hip Disability and OSteoarthritis Outcome Score (HOOS) pain and activities of daily living (ADL) scores. Multivariate logistic regression models with 95% confidence interval were used to identify independent predictors of pain and function at 5 years. ResultsThe patient dissatisfaction percentage was 8.2% at 5 years after THA. The multivariate regression identified the following predictive factors for the HOOS pain score at 5 years: age, educational level, insurance, smoking, race, Charlson Comorbidity Index, back pain severity, number of other lower extremity painful joints, the Knee Injury and Osteoarthritis Outcome Score pain severity of the ipsilateral knee, preoperative Short-Form Health Survey 36-item (SF-36) mental component summary score, and HOOS pain scores. The multivariate regression identified the following predictor factors for HOOS ADL score at 5 years: body mass index, insurance, smoking, race, back pain severity, number of other lower extremity painful joints, Knee Injury and Osteoarthritis Outcome Score pain severity of ipsilateral knee, preop HOOS ADL, and preoperative SF-36 mental component summary score and SF-36 physical component summary score. ConclusionsOverall, 8.2% of patients were dissatisfied 5 years after primary THA. We have identified a number of factors that predict less improvement in pain and function 5 years after THA. These potentially modifiable factors can be targeted with preoperative patient optimization programs to improve patient outcomes and satisfaction after primary THA. Knowledge of these factors that predict less improvement in pain and function can assist the surgeon and patient during shared decision-making, and in setting appropriate patient expectations preoperatively.

Retrospective Cohort Studies in Craniofacial Outcomes Research: An Epidemiologist's Approach to Mitigating Bias.

Retrospective cohort studies, defined as a follow-up study in which outcome occurred prior to study onset, are common in craniofacial outcomes research and will continue to be prevalent given the increasing availability of secondary datasets and inherent prospective study limitations. However, if available data are not adequately measured, or necessary variables are absent, retrospective cohort studies can be particularly prone to bias. This brief communication aims to highlight the primary sources of bias, including measurement error, selection bias, and confounding. Each source is clearly defined, examples pertinent to craniofacial outcomes are provided, and mitigation strategies are discussed.

Evaluation of the German Version of the Keratoconus Outcomes Research Questionnaire.

To translate, validate, and evaluate the psychometric properties of the German version of Keratoconus Outcomes Research Questionnaire (KORQ). This prospective study included 3 phases. In phase 1, the KORQ was translated in a standardized way; in phase 2, Rasch validation was performed; in phase 3, the validated questionnaire was evaluated in a separate patient cohort. All patients answered the German KORQ. Scheimpflug imaging (Pentacam) and optical coherence tomography scans (MS-39) were conducted. Corneal imaging measurements were correlated with patient-reported outcome measures. After standardized translation, 100 patients self-administered the German KORQ. Rasch analysis was conducted for psychometric testing of the KORQ. Based on the results of the Rasch analysis, the original German version of the KORQ was modified and any items showing a misfit were excluded. This resulted in a new shortened version of the KORQ, which was evaluated in 30 patients. The revised German KORQ met the criteria of Rasch analysis and showed excellent internal consistency reliability and convergent validity. The correlation between the KORQ score and various clinical measurements was examined using Spearman correlation. A significant moderate correlation was observed between the D (r = 0.237; P = 0.006) and Kmax (r = 0.162; P = 0.065) values of Pentacam. Inverse correlations were observed for thinnest pachymetry measured with MS-39 (r = -0.167; P = 0.058) and best corrected visual acuity (r = -0.210; P = 0.016). The shortened German KORQ met the assumptions of the Rasch model and displayed satisfactory psychometric properties. The German KORQ could be adopted as a powerful patient-reported outcome measures tool for German-speaking patients with keratoconus in the future.

Translation and linguistic validation into Spanish of the Owner-Reported Outcome Measure "Liverpool Osteoarthritis in Dogs".

Assessing chronic pain in dogs has been greatly favoured by the development of Owner-Reported Outcome Measures. Among them, the Liverpool Osteoarthritis in Dogs (LOAD) has been widely used for this purpose. Most of these tools have been written in English and its use by non English natives requires not only translation but also linguistic validation for use by veterinarians and owners. For its use, the LOAD has not undergone translation into Spanish and the objective was to generate a linguistically validated Spanish translation of the LOAD. Following the World Health Organisation and the International Society for Pharmacoeconomics and Outcomes Research published guidelines, the original LOAD English version underwent analysis and translation by two native linguists proficient in the target language. Both translations were then reviewed by a third native linguist to identify potential disparities and establish a cohesive translation (reconciliation). Subsequently, an independent linguist, fluent in both English and the target language, conducted the back translation. Finally, the research team compared the original and back translated versions to pinpoint and resolve any significant differences. Following the creation of the translated version, a cognitive debriefing was conducted to assess the questionnaire within the target population. A total of 89 surveys were distributed to dog owners of varying ages, genders, and socioeconomic backgrounds. Although there were some suggestions and comments, and some adjustments were made, all respondents found the survey to be clear, achieving a linguistic validation of the Spanish LOAD.

State Level Policies on First Responder Mental Health in the U.S.: A Scoping Review.

A growing body of evidence demonstrates potential adverse mental health outcomes associated with exposure to occupational trauma among first responders. In response, policymakers nationwide are eager to work on these issues as evidenced by the number of states covering or considering laws for mental health conditions for first responders. Yet, little information exists to facilitate understanding of the impact of mental health-related policies in the United States on this important population. This study aims to identify and synthesize relevant state-level policies and related research on first responder mental health in the United States. Using a scoping review framework, authors searched the empirical and policy literature. State level policies were identified and grouped into two categories: (1) Workers' Compensation-related policies and (2) non-Workers' Compensation (WC) related policies. While benefits levels and other specifics vary greatly by state, 28 states cover certain first responder mental health claims under WC statutes. In addition, at the time of this study, 28 states have policies governing first responder mental health outside of WC. Policies include requiring mental health assessments, provisions for counseling and critical incident management, requiring education and training, providing funding to localities for program development, bolstering peer support initiatives and confidentiality measures, and establishing statewide offices of responder wellness, among others. Authors found a dearth of outcomes research on the impact of state level policies on first responder mental health. Consequently, more research is needed to learn about the direct impact of legislation and establish best practice guidelines for implementing state policy on first responder mental health. By conducting systematic evaluations, researchers can lay the foundation for an evidence-based approach to develop more integrated systems that effectively deliver and finance mental health care for first responders who experience work-related trauma. Such evaluations are crucial for building an understanding of the impact of policies and facilitating improvements in the support provided to first responders in managing mental health challenges arising from their work.

Psychometric Validation of the Patient-Reported Experience Measure (PREM) Questionnaire “HowRwe” in Patients With Respiratory Disease Receiving Home Respiratory Therapies

IntroductionThe patient experience is defined as all the interactions that occur between patients and the healthcare system. The experience of patients with respiratory disease with home respiratory treatments (HRT) is not captured in currently available Patient-Reported Outcome Measures (PROM). We present the psychometric validation of the Patient-Reported Experience Measure (PREM) ‘HowRwe’ in Spanish and for respiratory patients with HRT. Material and methodsAfter translation following ISPOR guidelines (International Society for Pharmacoeconomics and Outcomes Research), the questionnaire was administered to adult respiratory patients who were receiving treatment at Hospital Universitario de La Princesa. The administration was done in two stages with 6 months of difference between the pre- and post-test. ResultsWe studied 228 respiratory patients, with a mean (SD) age of 64.1 (13.2) years, 52.2% were men, 68.0% were married or coupled, and 56.6% were retired. Reliability coefficients of the scale were adequate, with α=.921 and Ω=.929 for pre-test, and α=.940 and Ω=.958 for post. The confirmatory factor analysis tested for pre- and post-intervention, showed an excellent overall fit: χ2(2)=49.380 (p<.001), CFI=.941 and SRMR=.072; and χ2(2)=37.579 (p<.001), CFI=.982 and SRMR=.046, respectively. No statistically significant associations were observed for neither age, adherence nor quality of life, except between HowRwe post-test and quality of life pre-test (r=.14 [.01,.26]; p=.035). No significant differences were found in sociodemographic variables. No differences in pre-test or post-test were found in effect of HRT. 85.6% of patients found the content of HowRwe “Useful”, and the preferred channel to respond it were paper, app and email. ConclusionsThe Spanish version of the ‘HowRwe’ questionnaire to measure the experience in respiratory patients with home respiratory treatments (HRT), has adequate psychometric properties and conceptual and semantic equivalence with the original English version.

Analysis of the health economics portfolio funded by the National Institutes of Health in response to published guidance.

Health services, economics, and outcomes research (referred to as health economics research hereinafter) is one of the interdisciplinary sciences that the National Institutes of Health (NIH) supports in order to pursue its overall mission to improve health. In 2015, NIH guidance was published to clarify the type of health economics research that NIH would continue to fund. This analysis aimed to determine if there were changes in the number of health economics applications received and funded by NIH after the release of the guidance. Health economics applications submitted to NIH both before and after publication of the guidance were identified using a machine learning approach with input from subject matter experts. Application and funding trends were examined by fiscal year, method of application (solicited vs. unsolicited), and activity code. This study found that application and funding rates of health economics research were decreasing prior to guidance. Following publication of this guidance, the application and funding rate of health economics applications increased.

Exploring the Use of Pictorial Approaches in the Development of Paediatric Patient-Reported Outcome Instruments: A Systematic Review.

Children may find self-reporting health-related quality of life (HRQoL) using patient-reported outcome measures (PROMs) presented in text-based formats difficult, particularly younger children and children with developmental delays or chronic illness. In such cases, pictorial PROMs (where pictorial representations are used alongside or to replace text) may offer a valid alternative. This systematic literature review focused on identifying and describing paediatric PROMs that incorporate pictorial approaches, providing children with more effective means to express their HRQoL. Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines were followed. Seven electronic databases were searched from inception to 1 March 2022. There were no country restrictions applied to the search; all English-language studies were considered for inclusion in the review. Characteristics and development methods of the identified pictorial PROMs were evaluated against context-specific good practice guidelines published by The Professional Society for Health Economics and Outcomes Research (ISPOR). A total of 22 paediatric pictorial PROMs, comprising 28 unique versions, were identified. These PROMs were predominantly developed in the USA and the UK, targeting children aged 3-18 years. Likert scales with pictorial anchors, particularly happy-sad faces, were commonly used for response options, appearing in 15 (54%) of the PROMs. Various graphic methods, such as happy-sad faces, cartoons, and thermometers, were adapted to specific content domains. These PROMs covered a wide range of domains, including physical and emotional health and social functioning. Emphasis was placed on content validity, including active child participation in developing pictorial elements. Notably, children's participation was sought during the development of the pictorial elements for 13 (46%) of the PROMs. Various development methods were employed, with 43% of paediatric PROMs using literature reviews, 43% using focus groups, and 32% involving expert consultation. Interviews emerged as the primary method, being employed in 61% of the studies. Additionally, three measures specifically addressed cross-cultural considerations. Paediatric pictorial PROMs offer child-friendly tools for assessing HRQoL for application with children who find reading and understanding text-based PROMs challenging. There is some evidence that pictorial PROMs facilitate self-report in this population and improve measurement properties compared to text-only PROMs. Further research is needed to develop, validate, and test paediatric pictorial PROMs, with an emphasis on including children from the inception in the co-design process.

(281) Linguistic and Cultural Validation of the Satisfaction Survey for Inflatable Penile Implant (SSIPI) for Brazilian Portuguese and Tri-Continental Spanish Speakers

Abstract Introduction The Satisfaction Survey for Inflatable Penile Implants (SSIPI) has been validated in English. No validated Portuguese and Spanish versions currently exist. Objective We aimed to linguistically validate SSIPI in Portuguese and Spanish to evaluate satisfaction outcomes with a validated instrument. Methods Our methodology adhered to best practices established by the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) and involved: forward translation of the 16-item SSIPI into Portuguese and Spanish by 2 independent IPP surgeons, reconciliation, back translation into English by 2 different independent bilingual IPP surgeons, and comparison to the original SSIPI for conceptual equivalence. The translated SSIPI versions underwent in-parallel cognitive debriefing (CD) at the US, Colombia, Spain, and Brazil centers. All interviews were recorded in person or via secure video conference to determine if misunderstandings or modifications were needed. Results 12 and 17 native Portuguese and Spanish speakers, respectively, with IPPs, participated in the CD process for their native language SSIPI. Interviews lasted approximately 1 hour each. The Portuguese SSIPI validation was conducted at 2 different centers in Brazil, resulting in 83% of the patients reporting that the survey was easy to answer. Of 16 questions, only 3 (Q7, Q11, and Q16) raised concerns for 6 patients. 5 patients had issues with the concept of the word “naturalness” and “spontaneity” from Q7 and Q16. One patient struggled with interpreting the word “conceal” in Q11. Regarding the duration taken to answer, 10/12 patients said it was acceptable. The Spanish SSIPI was tested at 4 US, Colombia, and Spain academic centers. 63% indicated the survey was easy to answer. In most cases, replacing a single word in the item with another was proposed. 53% had difficulties comprehending the answer choice options with Q3; however, all participants perceived the time required to complete the SSIPI as reasonable. Conclusions While the Portuguese SSIPI has been demonstrated to be easier to read and interpret than the Spanish SSIPI, with minor changes to wording/phrasing, both versions have the potential to improve IPP outcomes literature globally. Concerning questions will be modified before conducting the final validation steps. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Roman.

Patient-centered research in pediatric transplant: Engaging families and recipients

Pediatric liver transplant (LT) recipients navigate a lifelong journey that includes constant monitoring and challenges. Research priorities and questions in LT have traditionally been provider-driven. This project was a novel partnership between a learning health system dedicated to pediatric LT (Starzl Network for Excellence in Pediatric Transplantation) and a parent-led advocacy group (Transplant Families) that aimed to prepare families and providers for collaborative patient-centered outcomes research (PCOR). We developed 5 virtual modules to (1) teach participants about PCOR, and (2) elicit ideas for PCOR priorities and processes in pediatric LT. Parents and providers participated via self-guided online modules or focus groups. Participants included 240 patient partners and 133 pediatric LT providers from 16 centers over 2 years. We held 20 focus groups, including 5 to amplify underrepresented voices: young adults, Spanish speakers, and African Americans. Feedback was summarized to create a PCOR Roadmap, a guide for future PCOR in the Starzl Network, which was disseminated back to participants online and via webinars. Feedback from a diverse group of stakeholders allowed us to develop PCOR priorities and processes for the pediatric LT community. Our engagement strategies could be adapted by other transplant communities to facilitate patient and provider research partnerships.

Estimating Utility Values for Health States of Nigerian Individuals with Stroke or Epilepsy Using the SF-36: A Brief Report on the Results of a Cross-Sectional Survey.

We estimated a health state utility value for stroke and epilepsy to aid researchers and public health policy makers in conducting health economic analysis and outcomes research.

Abstract 5: National Institutes of Health Stroke Scale Reporting in Administrative Claims Data: Incomplete and Biased Reporting in the First Three Years

Background: Since 2016, hospitals have been able to document International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) codes for National Institutes of Health Stroke Scale (NIHSS). As of 2023, Center for Medicare &amp; Medicaid Services uses NIHSS as a risk adjustment variable. We assessed associations between patient- and hospital-level variables and contemporary NIHSS reporting using Medicare datasets. Methods: Retrospective cross-sectional analysis of acute ischemic stroke (AIS) admissions from October 1, 2016-December 31, 2019 using de-identified, national 100% inpatient Medicare datasets. Index AIS admissions were identified using the ICD-10-CM code of I63.x. Demographic information, medical comorbidities, hospital characteristics, and NIHSS were abstracted. Medicare and Mount Sinai Health System registry data were linked using a matching algorithm. We calculated documentation of NIHSS at the patient and hospital level, predictors of NIHSS documentation, change over time, and concordance with local registry data. Results: There were 770104 index AIS admissions. NIHSS was documented in 40.1% of AIS admissions and by 62.5% of hospitals. Hospitals documenting ≥1 NIHSS were more commonly teaching hospitals, in metropolitan areas, stroke certified, higher-volume, and had ICU availability. Adjusted odds of documentation were lower for patients of black race compared to white and with inpatient mortality, increasing Charlson comorbidity score, discharge home, and treatment in non-metropolitan areas. NIHSS was documented for 52.9% of Medicare cases even though it was documented in 93.1% of registry cases, and 74.7% of Medicare NIHSS scores equaled registry admission NIHSS. Conclusions: Hospitals face financial implications for risk-standardized mortality rate adjustment, and administrative data play an increasingly important in stroke health services and outcomes research. Yet, missing ICD-10-CM NIHSS data remains widespread three years after introduction of the ICD-10-CM NIHSS code, and there are systematic differences in reporting at the patient and hospital levels.

Bridging the Gap: A Community Advisory Board Promoting Community Engagement in Cancer Research for Ethnically Diverse Populations.

Prostate cancer disproportionately affects Black men in the United States, leading to higher mortality rates and health disparities. In addition, based on historical mistreatment and discrimination and the resulting distrust of the medical system, Black populations are consistently underrepresented in health care-related research. Addressing these challenges requires community-driven approaches integrating diverse perspectives and fostering equitable health outcomes. This article describes the formation and impact of The Multidisciplinary Health Outcomes Research and Economics (MORE) Lab Community Advisory Board (CAB) at The University of Oklahoma Health Sciences. We purposefully recruited Black men with CaP and Black health care professionals to serve on a CAB and advise on ongoing research to address quality of life (QoL) issues in ethnically diverse Black CaP survivors. The CAB seeks to mitigate CaP disparities and improve health equity by empowering Black voices and promoting collaborative research practices. The MORE Lab CAB has successfully provided a venue for community members to contribute to designing a culturally relevant research program to improve the QoL in ethnically diverse Black men with CaP. The CAB has been instrumental in developing research goals and tools, implementing a series of town hall meetings to educate and support Black CaP survivors, and disseminating research findings. In conclusion, CABs are potentially critical in guiding research, enhancing community engagement, and advocating for culturally responsive health interventions.