Patient-reported Health Research Articles

Evaluating patient-reported health outcome profiles of lower limb orthosis users

Purpose To construct self-reported health outcomes profiles of lower limb orthosis users and compare scores to a normative sample representative of the United States general population. Materials and methods A cross-sectional online survey, which included the Patient-Reported Outcomes Measurement Information System Profile v2.0 (PROMIS-29), was administered to a national sample of adult lower limb orthosis users who had at least 6 months of experience using their orthosis. Results Relative to the U.S. general population, the 1,036 study participants report significantly worse anxiety, fatigue, pain interference, physical function, and ability to participate in social roles and activities (all p < 0.001). Differences in pain interference, physical function, and ability to participate in social roles and activities were all greater than 5 points. Subgroup analyses indicate those who also use assistive devices (e.g. canes, walkers) in addition to their orthoses generally have worse scores across multiple PROMIS domains. Conclusions Results of this study indicate lower limb orthosis users, as a group, report significantly worse health outcomes than the general population. These findings highlight health constructs that may be important to assess in clinical care and research and provide references scores for this patient population.

Worse Pain and Disability at Presentation Predicts Greater Improvement in Pain, Disability, and Mental Health in Patients Undergoing Minimally Invasive Transforaminal Lumbar Interbody Fusion for Degenerative Spondylolisthesis.

Retrospective Review. To assess the impact of preoperative pain and disability on patient-reported outcome measures (PROMs) following minimally invasive transforaminal lumbar interbody fusion (MI-TLIF) for degenerative spondylolisthesis. Varying preoperative symptom severity in lumbar fusion patients alters perceptions of surgical success. Degenerative spondylolisthesis patients undergoing elective, primary, single-level MI-TLIF were stratified by preoperative symptom severity: Mild (VAS-B<7/ODI<50), Moderate (VAS-B≥7/ODI<50 or VAS-B<7/ODI≥50), and Severe (VAS-B≥7/ODI≥50). PROMs, Patient-reported Outcomes Measurement Information System-Physical Function (PROMIS-PF), ODI, VAS-B, VAS-Leg (VAS-L), and 9-item Patient Health Questionnaire (PHQ-9) were compared at baseline, 6 weeks, and final follow-up (μ=16.3±8.8mo). Postoperative PROMs, magnitudes of improvement, and minimal clinically important difference (MCID) achievement rates were compared between cohorts through multivariable regression. A total of 177 patients were included. Acute postoperative pain and narcotic consumption were highest in the severe cohort ( P ≤0.003). All preoperative PROMs worsened from mild to severe cohorts ( P <0.001). All PROMs continued to be significantly different between cohorts at 6 weeks and final follow-up, with the worst scores in the Severe cohort ( P ≤0.003). At 6 weeks, all cohorts improved in ODI, VAS-B, VAS-L, and PHQ-9 (P≤0.003), with the Moderate cohort also improving in PROMIS-PF (P=0.017). All Cohorts improved across PROMs at the final follow-up ( P ≤0.044). Magnitudes of improvement in ODI, VAS-B, and PHQ-9 increased with worsening preoperative symptom severity ( P ≤0.042). The Moderate and Severe cohorts demonstrated higher MCID achievement in ODI, VAS-B, and PHQ-9 rates than the Mild cohort. Despite preoperative pain and disability severity, patients undergoing MI-TLIF for degenerative spondylolisthesis report significant improvement in physical function, pain, disability, and mental health postoperatively. Patients with increasing symptom severity continued to report worse severity postoperatively compared with those with milder symptoms preoperatively but were more likely to report larger improvements and achieve clinically meaningful improvement in disability, pain, and mental health.

Mavacamten in Symptomatic Nonobstructive Hypertrophic Cardiomyopathy: Design, Rationale, and Baseline Characteristics ofODYSSEY-HCM.

There are no approved therapies for patients with symptomatic nonobstructive hypertrophic cardiomyopathy (nHCM). The authors describe the baseline characteristics of ODYSSEY-HCM (A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy), a phase 3, randomized, double-blind, placebo-controlled trial conducted worldwide at 201 sites evaluating mavacamten in symptomatic adult patients with nHCM. The 2 primary endpoints are the changes from baseline to week 48 in: 1) Kansas City Cardiomyopathy Questionnaire 23-item Clinical Summary Score; and 2) peak oxygen consumption (pVO2) on cardiopulmonary exercise testing. Dose titrations are made on blinded core laboratory assessments. Of 1,088 patients screened, 580 are randomized (mean age 56 ± 15 years, 46% women, 43% with family histories). All patients are nonobstructive and symptomatic (70% in NYHA functional class II and 30% class III), with a mean Kansas City Cardiomyopathy Questionnaire 23-item Clinical Summary Score of 58 ± 20, and 77% are on beta-blockers. The mean left ventricular ejection fraction and pVO2 are 66% ± 4% and 18±6mL/kg/min, respectively. ODYSSEY-HCM will report if mavacamten improves patient-reported health status and exercise capacity in patients with symptomatic nHCM. (A Study of Mavacamten in Non-Obstructive Hypertrophic Cardiomyopathy (ODYSSEY-HCM); NCT05582395).

P-1938. Impact of Race and Ethnicity on Patient-reported Health and Symptoms Following COVID-19 or Long COVID Diagnosis

Abstract Background SARS-CoV-2 infection and COVID-19 hospitalization and mortality rates are higher in Black and Hispanic patients compared to White patients. Patient perspectives give key insights into healthcare inequities and treatment disparities. This study aimed to describe differences in the perceptions of health status and COVID-19 symptoms by race and ethnicity. Methods An online survey was conducted by the Harris Poll in the US (March 12-April 1, 2024) among adults aged ≥18 y diagnosed with, but not hospitalized for, COVID-19 or Long COVID (LC) in the past 12 months. Non-demographic data were weighted by age, gender, race/ethnicity, region, education, marital status, household size, household income, and propensity to be online to align them with their real-world proportions. Outcomes were compared among non-Hispanic White (White), non-Hispanic Black (Black), and Hispanic participants. Statistical significance was determined by two-tailed t-test (95% CI). Results 3090 participants diagnosed with COVID-19 or LC in the past 12 months completed the survey, with equal representation of White, Black, and Hispanic participants. White participants were more likely than Black and Hispanic participants to be older, live in suburban areas, have a 4-y college education, and earn &amp;gt;$100,000 (Table 1). Black and Hispanic participants were more likely to live in the South and be employed full-time. More Black and Hispanic participants reported their current health as “Poor/Fair” than White participants (P &amp;lt; 0.05; Table 2). Compared to White participants, greater proportions of Black and Hispanic participants described their initial COVID-19 or LC symptoms as “Very/Somewhat Severe” (White: 40%; Black: 55%; Hispanic: 59%; P &amp;lt; 0.05) and reported difficulty breathing, nausea/vomiting, diarrhea, and persistent pain/pressure in the chest (P &amp;lt; 0.05; Table 3). More Black (19%) and Hispanic (23%) participants reported that gaining access to healthcare when needed was “Very/Somewhat Difficult” versus White participants (8%; P &amp;lt; 0.05). Conclusion Black and Hispanic participants recently diagnosed with COVID-19 or LC reported poorer health and more severe initial symptoms compared to White participants, which aligns with other studies highlighting healthcare disparities and treatment inequities. Disclosures Thomas F. Oppelt, PharmD, BCPS, Gilead Sciences, Inc: I am an employee of Gilead Sciences, Inc|Gilead Sciences, Inc: Stocks/Bonds (Public Company) Michael Caron, PharmD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Jamie Zagorski, MSN, FNP, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Rodney H. Taylor, PharmD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) Chinonso Akano, PharmD, Gilead Sciences, Inc.: Employee|Gilead Sciences, Inc.: Stocks/Bonds (Public Company) LaKeisha Williams, PharmD, MSPH, Gilead Sciences, Inc.: Grant/Research Support Gary A. Puckrein, PhD, Dexcom: Grant/Research Support|Gilead Sciences, Inc.: Grant support for National Minority Quality Forum|National Minority Quality Forum: Employee

Integrating the Patient Perspective into Healthcare and Real-World Evidence: The Multi-site, Cross-Disease, Patient-Centered Outcomes Research Project in the Medical Informatics Initiative (PCOR-MII)

Abstract This paper presents the Patient-Centered Outcomes Research within the Medical Informatics Initiative (PCOR-MII) project, focusing on the integration of patient-reported outcomes (PROs) into a large-scale national data sharing infrastructure, established in Germany by the Medical Informatics Initiative (MII). PCOR-MII aims to systematically address the interests of various stakeholders in patient-reported health data and three dimensions of clinical utility: (1) prediction, (2) monitoring, and (3) outcome assessment. The project builds upon harmonized technical, data, and compliance environments established at the participating institutions as part of the MII to deploy and roll out software solutions for capturing PROs and making them accessible within local electronic health record (EHR) systems. To overcome interoperability challenges, PCOR-MII is developing a construct-oriented PROM module for the Health Level 7 (HL7) Fast Healthcare Interoperability Resources (FHIR)–based German National Core Dataset. The project applies its approach to three patient populations with distinct characteristics: anorexia nervosa targeting risk prediction (dimension 1), kidney transplantation prioritizing health status and adherence monitoring (dimension 2), and persistent somatic symptoms primarily aimed at assessing and understanding outcomes (dimension 3). With their emphasis on different aspects of PROs, those application areas can serve as blueprints for a broader roll-out. PCOR-MII represents a structured and comprehensive effort to incorporate PROs into a national data infrastructure, promising more precise diagnostics, improved treatment decisions, and the generation of new biomedical insights. We believe that our structured approach may serve as a guiding framework for others aiming to implement PROs in diverse healthcare settings.

P0279 Assessing patient-reported health status in moderate-to-severe Crohn’s Disease and Ulcerative Colitis: Results from the communicating needs and features of IBD experiences (CONFIDE) survey

Abstract Background Crohn’s disease (CD) and Ulcerative colitis (UC) affect patients’ physical and emotional well-being, posing substantial challenges to daily functioning.1 The CONFIDE study explored patients’ perspectives on the experiences and impact of CD and UC-related symptoms in the US, Europe (France, Germany, Italy, Spain, and UK), and Japan. Here, we assessed the impact of moderate-to-severe CD or UC on self-reported health status using the EQ-5D-5L questionnaire. Methods Online, quantitative, cross-sectional surveys were conducted among patients with moderate-to-severe CD or UC, defined by criteria based on previous treatment, steroid use, and/or hospitalisation. EQ-5D-5L assesses health status across 5 dimensions—mobility, self-care, usual activities, pain/discomfort, and anxiety/depression—rated from 1 (no problems) to 5 (extreme problems). It also includes a visual analogue scale (VAS) to rate current health from 0 (worst) to 100 (best).2 Descriptive statistics were used to summarise data. Results The analysis included 547 European (males [M]=55%, mean age=38 years [yrs]), 215 US (M=55%, 41 yrs), and 99 Japanese (M=68%, 43 yrs) patients with CD and 556 European (M=57%, 39 yrs), 200 US (M=62%, 40 yrs),and 124 Japanese (M=70%, 49 yrs) patients with UC. Of these, 347 (63%) European, 125 (58%) US, and 86 (87%) Japanese patients with CD, and 301 (54%) European, 153 (77%) US, and 52 (42%) Japanese patients with UC were receiving advanced therapies at data collection. Mean EQ-5D VAS scores were 67.9, 65.0, and 70.7 for European, US, and Japanese patients with CD, and 67.2, 67.0, and 73.1 for those with UC. Similar results were observed in patients receiving advanced therapies (Figure 1). Table 1 summarises health status across EQ-5D-5L dimensions. Of the 5 dimensions, most patients reported pain/discomfort and anxiety/depression. Overall, 81% European, 86% US, and 60% Japanese patients with CD reported ‘slight’ to ‘extreme’ pain/discomfort, while 74% European, 70% US, and 52% Japanese patients reported ‘slight’ to ‘extreme’ anxiety/depression. For UC, the percentages were 80% European, 91% US, and 39% Japanese patients for pain/discomfort, and 72% European, 80% US, and 40% Japanese patients for anxiety/depression. Conclusion Despite receiving advanced therapies, patients with CD or UC in Europe, US, and Japan reported impaired overall health by EQ-5D VAS scores. The European and US cohorts reported worse health, with a higher proportion of patients reporting problems across EQ-5D-5L dimensions than the Japanese cohort, possibly resulting from differences in characteristics of survey respondents, environment (e.g., bathroom access) and healthcare.

P1277 Cost-effectiveness of BOOST online intervention for supported self-management of pain, fatigue and bowel incontinence in Inflammatory Bowel Disease

Abstract Background People with IBD often experience symptoms of abdominal pain, fatigue and bowel incontinence that affect substantially their daily lives1. IBD-BOOST is the first randomised controlled trial (RCT) assessing the effectiveness of an online self-management intervention, BOOST, in managing these symptoms in IBD2. We report the cost-effectiveness of BOOST intervention compared to care as usual for people with IBD. Methods A cost-utility analysis was conducted alongside the pragmatic IBD-BOOST RCT of 780 patients requesting help for pain, fatigue or incontinence symptoms (mean age 49 years, 67% women, 55% with Crohn’s disease)3. The BOOST intervention costs and costs from patient-reported health service use, out-of-pocket expenses and time off work were calculated for each participant over the 12 months of follow-up. Quality-adjusted life-years (QALYs) over the 12 months were evaluated using the EQ-5D-5L questionnaires administered to participants at baseline, 6- and 12-months. Missing data (13% at 6 months and 38% at 12 months across the trial arms) was imputed using multiple imputation. Differences in total costs and QALYs between study arms were estimated using mixed effects models adjusting for pre-specified baseline factors. Incremental cost effectiveness ratios (ICERs) and net monetary benefit from UK healthcare and societal perspectives are reported. Results At recruitment, study participants reported quality of life (EQ-5D utility) of 0.73 (SD 0.22) and overall IBD-related costs of £2321 (SD 3170) over the previous 3 months with cost of biologics accounting for 47% of these costs, followed by hospital outpatient services (22%) and work productivity loss costs (14%) (Figure 1). After missing data imputation and controlling for covariates, the BOOST intervention (£151 per participant) was estimated to have led to health care cost savings of £746 (SE 356), other costs savings of £89 (SE 236) and incremental QALYs of 0.017 (SE 0.007) over the one-year follow-up per participant resulting in cost savings per QALY gained of £34,599 from the health services perspective and £39,745 from the societal perspective. The probability that the BOOST intervention was cost effective when compared with usual care was above 98% for willingness-to-pay thresholds of £20,000 to £30,000 from both health services and societal perspectives (Figure 2). Conclusion Our findings indicate that the BOOST intervention for supported self-management of symptoms of pain, fatigue and bowel incontinence in people with IBD is cost-effective.

Geriatrics-Focused vs Traditional Primary Care in the Veterans Affairs Health Care System

Older adults often require specialized health care expertise, but the effects of geriatrics-focused models of primary care have not been fully evaluated. To compare the effects of geriatrics-focused primary care vs traditional primary care for older patients in the Veterans Affairs (VA) health care system. In this cohort study, geriatrics-focused primary care and traditional primary care patient dyads matched on variables associated with geriatrics-focused primary care entry and outcomes were enrolled from VA medical centers with operational geriatrics-focused primary care clinics serving 500 or more patients annually in fiscal year 2016. Across 57 eligible sites, patients 65 years or older who transferred their care to geriatrics-focused primary care within the previous 12 months (exposure period) (n = 291) and their matched traditional primary care controls (n = 277) were enrolled. Study recruitment occurred from March 22, 2018, through December 11, 2019, with patient outcomes data collection completed June 24, 2021. Data were analyzed from June 2023 to January 2024. At least 2 geriatrics-focused primary care visits during the exposure period. Geriatrics-focused primary care involves interprofessional teams of clinicians with geriatrics expertise to provide comprehensive primary care for older veterans with complex needs. The primary outcome was home time (days not in a hospital unit, short-term nursing facility, inpatient rehabilitation, or an emergency visit) within 18 months of the exposure period. Secondary outcomes were completion of advance directives, assessments (falls, incontinence, and function), and medication quality (potentially inappropriate medications, Anticholinergic Drug Scale score). Patients were surveyed over 18 months about care experiences using Patient Perceptions of Integrated Care subscales, and Patient-Reported Outcomes Measurement System self-reported health and well-being measures. A total of 568 patients were enrolled (mean [SD] age, 80.5 [7.0] years; 558 [98.2%] male), including 291 in the geriatrics-focused primary care and 277 matched in the traditional primary care groups; most baseline variables were comparable between the 2 groups. Geriatrics-focused primary care was not associated with more home time (rate ratio, 0.97; 95% CI, 0.62-1.51) over 18 months. Geriatrics-focused primary care was associated with higher odds of assessment for falls (odds ratio [OR], 2.86; 95% CI, 1.62-5.04), incontinence (OR, 2.73; 95% CI, 1.69-4.42), and function (OR, 4.05; 95% CI, 2.39-6.85) at 18 months. Geriatrics-focused primary care was not associated with advance directive completion, medication quality, or self-reported health and well-being. In this cohort study, geriatrics-focused primary care did not increase time at home or other measures of self-reported health and well-being or integration of care within the first 18 months after care transition. However, increases in some process measures important for quality of care were observed, suggesting that further studies are needed to evaluate outcomes over a longer time frame.

Patient-Reported Outcomes Following Total Knee Arthroplasty With Multiple Sclerosis Demonstrate Similar Functional Outcome Measures: A Propensity-Matched Analysis

Introduction: Multiple sclerosis (MS) may negatively influence the patient-reported outcomes measures (PROMs) when undergoing total knee arthroplasty (TKA). However, functional outcomes in this select population remains poorly characterized. This study aimed to compare clinical outcomes and rate of achieving Minimal Clinically Important Difference for Improvement (MCID-I) and Minimal Clinically Important Difference for Worsening (MCID-W) between MS and non-MS TKAs. Methods: We did a retrospective analysis of 61 TKAs in MS patients performed between 2015 and 2022 and it was propensity matched in a 3:1 ratio with 123 non-MS patients. Preoperative and postoperative assessments included Patient-Reported Outcomes Measurement Information System Global Health Mental and Physical, Patient-Reported Outcomes Measurement Information System Physical Function short form 10-a (PF-10a), and Knee injury and Osteoarthritis Outcome Score-Physical Function Short-form scores. Patients were categorized based on achieving MCID-I, MCID-W, or showing “no change” after TKA. Results: A total of 244 TKAs (61 MS and 183 matched non-MS) were analyzed. MS TKAs had similar length of stay but lower rate of home discharges (73.8% vs. 90.2%, P = 0.003) compared with non-MS patients. Notably, both cohorts had similar rates of achieving MCID-I and MCID-W among all four PROM scores. However, MS patients had a notable higher rate of 90-day postoperative complications (26.2% vs. 12.6%, P &lt; 0.001), revision surgeries (11.5% vs. 4.4%, P = .045), and revisions (6.6% vs. 0.5%, P = 0.004). Conclusion: Using MCID methodology, this study found that MS patients have similar rates of achieving MCID-I and MCID-W but have higher rate of postoperative complications, revision surgeries, and revisions when compared with non-MS patients. These findings highlight that despite the elevated risks of complications, MS patients can achieve similar improvements to their non-MS counterparts. Further investigations into the long-term outcomes of MS patients are warranted to the determine the effectiveness of this intervention.

Higher serotonin levels among patients with rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis compared to healthy controls assessed by liquid chromatography-tandem mass spectrometry (LC-MS).

Growing evidence suggests that serotonin is an important mediator in the cross-talk between immune and bone cells, playing a role in the pathogenesis of various types of inflammatory arthritis (IA). However, the relationship between circulating serotonin and different outcomes in three most prevalent IA - rheumatoid arthritis (RA), psoriatic arthritis (PsA), and axial spondyloarthritis (axSpA), remains limited and requires further investigation. This study was performed to evaluate variations in serotonin serum levels among RA, PsA, and axSpA and to explore the utility of this biochemical marker in the assessment of disease activity and health status measurements provided by the Multi-Dimensional Health Assessment Questionnaire (MDHAQ). This was a cross-sectional study using data from the PolNorRHEUMA registry. Demographic and clinical data, as well as blood samples, were collected during routine visits to the rheumatology outpatient clinic. We included 60 patients (20 with RA, 20 with PsA, and 20 with axSpA) and 45 healthy controls, with a mean age of 49 years and 56.2% female. A reliable liquid chromatography-tandem mass spectrometry (LC-MS) method was used for the quantitative determination of serotonin in blood serum. Analysis of serotonin levels, based on 105 observations and adjusted for age, SSRI/SNRI intake and physical activity, revealed a significant elevation in the patient groups compared with the controls (p < 0.001): 134.00 ng/mL in healthy controls vs. 176.00 ng/mL in RA, 183 ng/mL in PsA, and 184.00 ng/mL in axSpA, with no statistically significant differences between the respective forms of IA. We found no significant correlation between the serotonin concentration and disease activity composite scores. A sample of 51 patients revealed a significant positive correlation between the serotonin concentration and global MDHAQ scores (β = 0.01, p = 0.009), indicating that an increase in serotonin levels is associated with worsening patient-reported health status. The serotonin serum concentration was higher in patients with RA, PsA, and axSpA than in controls, indicating its potential as a biomarker of inflammation and worse health status. The LC-MS method was successfully applied for the analysis of serum.

Did Finerenone Improve Health Status in the FINEARTS Trial?: A Critical Reevaluation of the Analysis of Patient-Reported Outcomes in Heart Failure.

Patient-reported health status is an important assessment of patients with heart failure, but current approaches have substantial methodological and analytical limitations. Changes in the Kansas City Cardiomyopathy Questionnaire (KCCQ) are commonly presented as a measure of the effect of drugs and devices, most often as the between-group difference in population means or as the odds of showing threshold changes of 5, 10, 15, and 20 points. However, the presentation of mean differences is based on statistical assumptions that are routinely violated in most trials. The presentation of threshold changes is based on the belief that a within-patient change in KCCQ of 5 points represents a significant treatment difference across diverse populations and trial settings, but the minimal clinically meaningful difference varies substantially depending on patient characteristics, comorbidities, and trial duration and design, with most values for minimally clinically important difference for KCCQ ranging from 10 to 20 points. Furthermore, the assessment of between-group differences is highly distorted by the assignment of a large proportion of randomized patients with very good health status as having substantially improved even if they showed no change after treatment. Any responder analysis is highly sensitive to differences in variance between the 2 treatment groups and cannot account for the stability of changes in the KCCQ score. The imposition of number-to-treat presentations onto KCCQ scores further compounds the lack of interpretability of reported changes. It is therefore not surprising that trials have reported substantial discrepancies between the effect of treatment on KCCQ and on the risk of hospitalizations for heart failure. In the FINEARTS (Finerenone Trial to Investigate Efficacy and Safety Superior to Placebo in Patients with HeartFailure) trial, finerenone produced an 18% reduction in the risk of hospitalizations for heart failure but yielded uninterpretable and clinically questionable changes in KCCQ, with the small possibility of a modest benefit in<2% of randomized patients. Most physicians are unaware of the critically important methodological concerns summarized in the current paper, and, therefore, may make clinical decisions that hinge on unwarranted impressions of the effects of an intervention on health status.

Knee pain and function in retired male intercounty GAA players: an exploratory study.

Knee injuries are common among elite intercounty Gaelic games players (collectively GAA players). The primary aim was to examine knee pain, function, and quality of life in retired elite male GAA players. Secondary objectives were to (i) report the incidence of previous knee surgery and total knee replacement, (ii) assess medication usage, and (iii) investigate any associations between a history of knee injury and/or knee surgery and knee pain, function, and quality of life among retired elite male GAA players. One hundred retired male senior intercounty GAA players were surveyed on their history of severe knee injury and previous knee surgery (68 completed survey; 47 Gaelic football, 20 hurling, 1 dual player). The Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS) and the Patient-Reported Outcomes Measurement Information System Global Health (PROMIS-GH) were used to assess level of function and pain. Forty-seven (69%) of the retired players described experiencing at least one severe knee injury during their intercounty career. Fourteen (21%) participants retired due to a significant knee injury. Mean KOOS-SP score was 75.5 (SD 17). The Global Physical Health and Global Mental Health mean scores were 44 and 51. There was a low negative correlation between KOOS-SP scores and a history of severe knee injury (r = -0.35, p = 0.001). Moderate negative correlation between Global Mental Health scores and a history of severe knee injuries (r = -0.36, p = 0.386) and a very weak negative correlation between the number of surgeries during a participant's intercounty career and Global Mental Health score (r = -0.089, p = 0.234). Severe knee injuries and knee surgery are common among male intercounty GAA players. These injuries lead to self-reported reduced performance and retirement and are potentially associated with worse health-related outcomes post-intercounty career. Further well-designed studies, including among retired women GAA players, are required to assess the relationship between knee injuries and long-term athlete outcomes. Improved injury prevention efforts, enhanced rehabilitation of knee injuries, and post-retirement care may mitigate the adverse effects associated with severe knee injuries among male GAA players.

Health Communication and Adherence to Noninvasive Ventilation in Chronic Hypercapnic Respiratory Failure

Domiciliary noninvasive ventilation (NIV) is a standard treatment for improving health outcomes among patients with chronic hypercapnic respiratory failure (CHRF). However, poor adherence substantially limits its therapeutic effectiveness. To determine the effect of an information-motivation-behavioral (IMB) skills-based intervention (IMB-NIV program) on NIV adherence, patient-reported health outcomes, and health service use among patients with CHRF. This multisite, assessor-blinded, randomized clinical trial was conducted from January 2022 to March 2023 at respiratory clinics of 2 regional hospitals in Hong Kong among patients with CHRF who had been nonadherent to prescribed domiciliary NIV. The 6-week IMB-NIV program used a hybrid approach, combining in-person and telecare sessions, to provide patients with knowledge, skills, a positive attitude, and social motivation to enhance NIV adherence. The primary outcome was NIV adherence data retrieved from the NIV machine. Secondary outcomes included the Pittsburgh Sleep Quality Index, Chinese Severe Respiratory Insufficiency questionnaire, venous bicarbonate (HCO3-) level, emergency department (ED) and hospital admissions, and mortality measured at baseline, program completion, and 3, 6, and 12 months. Of the 124 participants (mean [SD] age, 73.7 [7.2] years; 67 [54.0%] female), the 62 patients in the IMB-NIV group were more likely to adhere to NIV compared with the 62 patients in the usual care group at 12 months (61.3% vs 27.4%; odds ratio, 2.78; 95% CI, 1.69 to 4.55), with a greater increase noted in daily NIV use in hours at that time (B = 2.37; 95% CI, 1.44 to 3.31). A generalized estimating equation indicated significantly greater improvements in sleep quality (B = -3.63; 95% CI, -5.14 to -2.12) and health-related quality of life (β = 14.84; 95% CI, 9.18 to 20.49) at 12 months in the IMB-NIV group. The IMB-NIV group had significantly lower ED admissions (incidence rate ratio, 0.47; 95% CI, 0.26 to 0.84) and a longer time to the first ED visit (hazard ratio, 0.51; 95% CI, 0.28 to 0.95). No significant treatment effect was observed on venous HCO3- levels or hospital admissions. In this randomized clinical trial, the IMB-NIV program offered a promising behavioral approach to improve NIV adherence in patients with CHRF. Its sustained positive effects on sleep quality, health-related quality of life, and ED admissions highlight its potential to optimize the therapeutic benefits of NIV. ClinicalTrials.gov Identifier: NCT05008211.

Arthritis Management: Patient-Reported Health Care Provider Screening, Counseling, and Recommendations for Physical Activity.

Little is known about the recency, correlates, and content of health care provider (HCP) counseling about physical activity (PA) among adults with arthritis. We analyzed data from the Porter Novelli FallStyles cross-sectional survey of noninstitutionalized US adults. Among adults with arthritis, we assessed the recency of HCP counseling about PA; counseling content, including PA assessment/screening and advice/counseling; and recommendations. Data were weighted by sex, age, household income, race and ethnicity, household size, education, census region, and metropolitan status. Among adults with arthritis (n = 1,113), 16.8% received HCP counseling within the past 6 months, 9.6% received counseling between 6 months and a year ago; 27.7% received HCP counseling more than a year ago; 30.4% never received HCP counseling; and 15.5% did not recall. Prevalence of HCP counseling about PA was higher for those reporting obesity (prevalence ratio [PR] = 1.3) and chronic pain (PR = 1.2), compared with those without these conditions. The most and least common content of HCP counseling were assessment of PA level (74.7%) and receiving a physical activity prescription (6.1%), respectively. The most frequent recommendations for PA type were flexibility exercises (40.1%), aerobic activities (39.8%), specific modalities of PA (eg, swimming, walking, dancing; 38.1%), and muscle-strengthening exercises (36.6%). Only 4.4% received a recommendation for arthritis-appropriate PA programs. HCP counseling about PA among adults with arthritis for arthritis symptom management is lacking in frequency, actionable content, and recommendations to engage in evidence-based PA interventions. Dissemination and implementation of policies and programs facilitating frequent high-quality HCP counseling and recommendation to PA programs for arthritis remains a public health priority.

Nurse-Led Multicomponent Behavioral Activation Intervention for Patients With Atrial Fibrillation: A Randomized Controlled Trial.

Patients with atrial fibrillation (AF) are often ill-equipped for shared decision-making. This study investigated the effects of a patient empowerment care model on patient-reported health outcomes and treatment decision-making in patients with AF. This randomized controlled trial prospectively randomized patients with AF to receive standard care (n=194) or a 13-week nurse-led multicomponent behavioral activation intervention (n=198). The intervention consisted of risk profile assessments, empowered shared decision-making regarding the use of oral anticoagulants (OACs), empowered AF self-management, and increased access to professional advice. The primary outcome was health-related quality of life measured after the completion of the intervention (T1), while the secondary outcomes were patient-physician decision concordance regarding OAC use, actual OAC use, AF knowledge, medication adherence, anxiety, and depression. The intervention group showed significantly greater improvements in health-related quality of life (β, -6.702 [95% CI, -9.556 to -3.847]; P<0.001), AF knowledge (β, -1.989 [95% CI, -2.342 to -1.635]; P<0.001), and medication adherence (β, 0.340 [95% CI, 0.148-0.532]; P<0.001) at immediate post-intervention compared with the control group, and the improvements were sustained at 6 months for all outcomes. A higher proportion of patients in the intervention group were prescribed an OAC compared with the control group at 6 months (odds ratio, 5.870 [95% CI, 1.957-12.331]; P=0.012). No significant between-group differences were detected for patient-physician decision concordance regarding OAC use, anxiety, or depression at both time points. The nurse-led multicomponent behavioral activation intervention improved patient-reported outcomes and increased OAC prescription among patients with AF.

Adhesion Prevention in Gynecologic Surgery: Guidance and Clinical Experience.

Postoperative adhesions represent a major medical challenge and are associated with serious health and economic consequences. 4DryField® PH (PlantTec Medical GmbH, Lueneburg, Germany) is a starch-based medical device designed both to prevent adhesions and for hemostasis. This paper explores methods to successfully apply it in gynecological surgery, leveraging the authors' extensive clinical experience. We provide detailed insights into best practices that benefit most patients with conditions such as endometriosis, along with practical tips and guidance on optimizing application and dosage. Our real-world clinical experience across various indications, supported by published data, demonstrates significant patient benefits: reduced adhesion formation, better recovery, less pain, and improved fertility. Patient acceptance and satisfaction are notably high. The device can be applied to surgical wounds as a powder for hemostasis and transformed into a gel in situ or as a premixed gel when adhesion prevention is prioritized. Specific advantages for each method are demonstrated by case studies. When used correctly, 4DryField PH is safe and effective, especially for larger wound areas with a high risk of reoperation and adhesion formation and when pregnancy is desired. It offers great versatility due to its use as either in situ gel or premixed gel with different viscosities. Despite some remaining gaps in clinical evidence and ongoing studies, our personal clinical experience suggests significant benefits with minimal risks. Therefore, we have no concerns regarding the broad use of 4DryField PH in gynecology and other surgical disciplines. Future research should focus on patient-reported outcomes and health economic benefits to support reimbursement efforts.

Letter by Yang and Zhang Regarding Article, “Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial”

Letter by Yang and Zhang Regarding Article, “Clinical Impact of Routine Assessment of Patient-Reported Health Status in Heart Failure Clinic: The PRO-HF Trial”

Five- Year Outcomes in Low-Risk Patients Undergoing Surgery in the PARTNER 3 Trial.

Surgery remains an important treatment for low-risk patients with severe symptomatic aortic stenosis (AS). This study evaluated 5-year outcomes in low-risk patients undergoing isolated surgical aortic valve replacement (SAVR) or SAVR with concomitant procedures within the randomized Placement of Aortic Transcatheter Valves (PARTNER) 3 trial. In the PARTNER 3 trial, 454 patients underwent surgery for severe, symptomatic, trileaflet AS and were followed up for 5 years. Patients were stratified into those undergoing isolated SAVR (n= 334; 73.6%) vs concomitant SAVR (n= 120; 26.4%). Short- and long-term morbidity was adjudicated by a Clinical Events Committee. Hemodynamic valve performance was evaluated by an echocardiographic core laboratory. Patient-reported health status was measured with the Kansas City Cardiomyopathy Questionnaire (KCCQ). The mean age of participants was 73.6 ± 6.1 years; 71.1% of these patients were male. The median SAVR implant size was 23 mm overall. Five-year all-cause mortality (with vital status sweep) was 9.0% for all patients (8.5% isolated SAVR; 10.2% concomitant SAVR; P= .58), comparable to a recent analysis of low-risk isolated SAVR-treated patients in the STS database (overall mortality, 7.1%). The average 5-year mean gradient was 11.7 ± 5.6 mm Hg overall. Reintervention rates were low in both groups (isolated SAVR, 2.3% vs concomitant SAVR, 5.0%; P= .21), and most patients (isolated SAVR, 87.9%; concomitant SAVR, 86.1%) were alive with no evidence of bioprosthetic valve failure at 5 years. SAVR in low-risk patients in the PARTNER 3 trial demonstrated excellent 5-year outcomes. Five-year mortality was similar in patients undergoing isolated SAVR vs concomitant SAVR. This result was comparable to recently published national SAVR outcomes, thus demonstrating the generalizability of these findings.

Dupilumab Treatment for Aspirin-Exacerbated Respiratory Disease in a Real-World Setting: Impact on Quality of Life and Healthcare Utilization.

Patients with aspirin-exacerbated respiratory disease (AERD) have difficult-to-treat asthma and chronic rhinosinusitis with nasal polyps (CRSwNP) and often require treatment with biologic therapy for asthma or CRSwNP. Healthcare utilization in patients with AERD has not been well described since the advent of respiratory biologics. To determine real-world healthcare utilization and quality of life among patients with AERD and to understand the impact of dupilumab, a monoclonal antibody targeting the interleukin 4 receptor, on patient-reported health outcomes and healthcare utilization. We conducted a longitudinal survey study of 98 patients with AERD recruited from the Brigham and Women's Hospital AERD registry. Patients completed online questionnaires describing their medication history, healthcare utilization, and quality of life every 3 months for 2 years. At the end of 24 months, participants who were on dupilumab at the start of the study and those who started dupilumab had a significant reduction in the number of reported poor health days in the preceding month compared to patients not on dupilumab (P < .001 and P < .01, respectively). Participants on dupilumab and those who started dupilumab also had significantly lower overall sinonasal outcome test-22 and asthma control test scores compared to those not on dupilumab over 24 months (P < .05 for both groups). Dupilumab therapy significantly improves health-related quality of life in patients with AERD, specifically as it pertains to patient assessment of days of overall poor health and quality of life related to sinonasal and asthma symptoms.

Higher preoperative patient expectations predict better patient-reported psychosocial health outcomes after hip arthroscopy

IntroductionPreoperative expectations are a determinant of patient-reported outcomes (PROs) within several orthopaedic subspecialties. However, the impact on outcomes after hip arthroscopy is unclear. The aim of this study was to explore the relationship between preoperative patient expectations and PROs after hip arthroscopy. MethodsPatients who underwent hip arthroscopy at a single institution were included. Patient expectations were measured preoperatively using the Musculoskeletal Outcomes Data Evaluation and Management System (MODEMS) expectations domain. Patient-Reported Outcomes Measurement Information System (PROMIS) domains, a numeric pain scale (NPS), and the Marx activity rating scale (MARS) were assessed 2 years postoperatively. Spearman's coefficient was used to assess the correlation between preoperative expectations and 2-year PROs. Linear regression was used to ascertain the effect of preoperative expectations on 2-year PROs. Results105 patients were included, and 78 (74 %) completed 2-year follow-up. The mean (SD) preoperative expectations score was 88.3 (15.3). Higher expectations correlated with better postoperative fatigue, anxiety, depression, pain, and activity levels, as well as more improvement in fatigue, pain, and activity. Expectations scores were higher for patients who achieved minimal clinically important difference (MCID) for PROMIS Fatigue (92.6 vs 82.0, p = .003) and MARS activity (95.3 vs 86.2, p = .014). When controlling for possible confounders, higher expectations independently predicted better postoperative PROMIS Fatigue (β = −0.26, SE = 7.23), Social Satisfaction (β = 0.24, SE = 0.09), and Anxiety (β = −0.24, SE = 0.08). ConclusionHigher preoperative expectations are an independent predictor of better psychosocial outcomes 2 years after hip arthroscopy. Setting positive expectations preoperatively may be important for enhancing psychosocial health postoperatively.