Patient-Reported Outcomes Measurement Information System Research Articles

Evaluation of participation in a former rehabilitation population: a comparison between USER-Participation Restriction and Satisfaction subscales and PROMIS Ability to Participate and PROMIS Satisfaction with participation 8-item short forms in a cross-sectional multicentre study

Background Several Patient Reported Outcome Measurements (PROMs) can be used to quantify participation in rehabilitation patients, yet there is limited comparative research on their content and psychometric properties to make an informed decision between them. Objective To compare the content and several psychometric properties of the Restriction and Satisfaction subscales of the Utrecht Scale for Evaluation of Rehabilitation – Participation (USER-P) with the Patient-Reported Outcomes Measurement Information System Ability to Participate in Social Roles and Activities (PROMIS-APS) and Satisfaction with Social Roles and Activities (PROMIS-SPS) v2.0 8-item short forms. Methods A cross-sectional survey among patients who received rehabilitation treatment (N = 563). Coverage of participation domains, distributions, inter-item correlations, internal consistency, construct validity, and discriminative validity were compared between the PROMs. Results The USER-P subscales cover more participation domains than the PROMIS short forms. All PROMs demonstrated adequate internal consistency (α > 0.82) and each had >75% of the hypotheses regarding construct validity confirmed. Conclusions The internal consistency, construct and discriminative validity were similar between the USER-P subscales and the PROMIS short forms. It appeared that the USER-P offers more broad information about participation on item level and the total scores of PROMIS short forms offer more precise general information regarding participation.

Females report worse outcomes than males one year after ventral hernia repair.

To assess sex differences in patient-reported quality of life, pain, and hernia recurrence after adjusting for confounding features of hernia disease in a large national registry one year after ventral hernia repair. Data were analyzed retrospectively from the Abdominal Core Health Quality Collaborative national registry from pre-operatively until one year post-operatively. 3,172 patients undergoing elective ventral hernia repair with 1-year follow-up data were included for analysis after propensity score matching (1:1 match; females: mean [interquartile range] age, 60 [49, 68]; body mass index, 32 [27, 36]; males: age, 60 [52, 68]; 31 [28, 35]. The primary outcome of interest between sexes was the Hernia Related Quality of Life survey (HerQLes), and secondary outcome measures included the Patient-Reported Outcomes Measurement Information System Pain Intensity (PROMIS) short form (3a) score and hernia recurrence. Female sex was associated with worse HerQLes and PROMIS pain 3a scores at 1 year follow up (adjusted mean difference, -2.42, 95% confidence interval (CI) -4.11 to -0.72; p = 0.004; adjusted mean difference, 1.27, 95% CI 0.67 to 1.87; p < 0.001) compared to male sex. Hernia recurrence rates at 1 year were not different between sexes. Females reported worse quality of life and higher levels of pain at 1-year post ventral hernia repair after accounting for age, BMI, hernia width, and baseline quality of life compared to males. There were no differences between females and males with respect to hernia recurrence at 1-year follow-up, and 1 in 5 patients experienced a recurrence at this time point.

Evaluating Meaningful Changes in Patient-Reported Outcome Measurement Information System-Fatigue Scores from Three Phase 3 Clinical Trials of Sarilumab for Patients With Rheumatoid Arthritis.

The aim of this study was to evaluate changes in fatigue measured by Patient-Reported Outcome Measurement Information System (PROMIS)-Fatigue scores in patients with rheumatoid arthritis (RA) who received sarilumab and to assess the proportion of patients achieving clinically meaningful change. Data from three phase 3 randomized controlled trials of patients with RA who received sarilumab-MOBILITY, TARGET, and MONARCH-were evaluated. The 10 RA-relevant items from the 13-item Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue were scored in the PROMIS T score metric. Mean changes in 10-item PROMIS-Fatigue T score (PROMIS-Fatigue 10a) were compared, proportions of patients reporting meaningful within-person change thresholds were assessed, and results were visualized using empirical cumulative distribution function (eCDF) curves. Patients with RA reported high baseline fatigue. Using PROMIS-Fatigue 10a, at week 24, patients receiving 150 or 200 mg sarilumab every other week in MOBILITY and TARGET had rapidly and significantly improved mean levels of fatigue compared to those who received placebo. When compared to patients who received adalimumab in MONARCH, patients who received sarilumab had a trend toward increased improvement. eCDF curves showed separation between active treatment versus placebo with both sarilumab doses and across the score range for improvement. Higher proportions of patients reported three-, five-, and seven-point improvements in PROMIS-Fatigue scores in groups who received active treatment. Substantial proportions of patients with RA who received sarilumab reported meaningful change in fatigue measured by PROMIS-Fatigue 10a over time. This study demonstrates the ability to convert FACIT-Fatigue score onto the PROMIS T score metric, the rapid reduction in fatigue with biologic therapies, and the use of novel eCDF curves to show individual patient-level change.

Ruxolitinib Cream Monotherapy Improved Symptoms and Quality of Life in Adults and Adolescents with Mild-to-Moderate Atopic Dermatitis: Patient-Reported Outcomes from Two Phase III Studies.

Atopic dermatitis (AD) is associated with itch, skin pain, sleep disturbances, and diminished quality of life (QoL). Ruxolitinib (Janus kinase [JAK] 1/JAK2 inhibitor) cream demonstrated efficacy and safety in adults and adolescents with mild-to-moderate AD in two phase III studies (TRuE-AD1/TRuE-AD2). In TRuE-AD1/TRuE-AD2, significant improvements in itch were observed as early as 12 h following application of ruxolitinib cream. The aim of this paper was to assess additional patient-reported outcomes (PROs) in the vehicle-controlled (VC) and long-term safety (LTS) periods of TRuE-AD1/TRuE-AD2. In the TRuE-AD studies, patients aged ≥12 years with AD were randomized 2:2:1 to apply twice-daily 1.5% ruxolitinib cream, 0.75% ruxolitinib cream, or vehicle cream continuously for 8weeks (VC period). During the LTS period, patients applied the same ruxolitinib cream strength, but on an as-needed basis; patients who initially applied vehicle were re-randomized to apply 0.75% or 1.5% ruxolitinib cream. Pooled data from both study periods were analyzed. PRO assessments included symptoms (itch [Patient-Oriented Eczema Measure, POEM], skin pain [numerical rating scale], and sleep [POEM and Patient-Reported Outcomes Measurement Information System]) and assessments of disease-specific QoL (Dermatology Life Quality Index [DLQI] and the children's version [CDLQI]). A total of 1208 and 1031 patients from the VC and LTS periods, respectively, were included in the analysis. Significant improvements in skin pain were observed within 12h among patients who applied ruxolitinib cream versus vehicle; improvements continued throughout the VC period. Improvements in patient-reported symptoms (including sleep) were observed within 2 weeks (first assessment) of ruxolitinib cream application. At Week 2, significant improvements in symptom burden and overall QoL were observed with ruxolitinib cream (0.75%/1.5%) versus vehicle in POEM (-8.9/-9.8 vs -2.2; both p<0.0001), DLQI (mean changes from baseline, -5.8/-6.1 vs -1.2; both p<0.0001), and CDLQI (-4.3/-5.3 vs -1.3; both p<0.0001). Further symptom burden and QoL improvements were reported during the VC period and were maintained through the end of the LTS period (Week 52). Consistent with the previously reported itch response data, ruxolitinib cream improved skin pain within 12 h of application. Ruxolitinib cream improved patient-reported AD symptom burden and overall QoL by Week 2. Improvements continued or were maintained for 52 weeks. (Graphical abstract and plain language summary available). ClinicalTrials.gov identifiers, NCT03745638 and NCT03745651 (both studies were registered on November 19, 2018).

Switching treatment to cipaglucosidase alfa plus miglustat positively affects patient-reported outcome measures in patients with late-onset Pompe disease

BackgroundLate-onset Pompe disease (LOPD), a rare autosomal recessive multisystemic disorder, substantially impacts patients’ day-to-day activities, outcomes, and health-related quality of life (HRQoL). The PROPEL trial compared cipaglucosidase alfa plus miglustat (cipa+mig) with alglucosidase alfa plus placebo (alg+pbo) in adult patients with LOPD over 52 weeks and showed improved motor and respiratory function in patients switching treatment from standard-of-care enzyme replacement therapy (ERT) to cipa+mig at baseline. This study evaluated the impact of cipa+mig on patient-reported outcomes (PROs), including HRQoL in ERT-experienced patients, using data from PROPEL.MethodsPROs evaluated included the Subject’s Global Impression of Change (SGIC), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a, PROMIS Fatigue Short Form 8a, Rasch-built Pompe-specific Activity (R-PAct), and European Quality of Life-5 Dimensions 5 Response Levels (EQ-5D-5L). The proportions of responders in the cipa+mig arm and the alg+pbo arm were compared via chi-squared or Fisher’s exact test (patient-level responder analysis), and least squares (LS) mean differences were calculated for change from baseline at Week 52 of the PRO measures (group-level analysis).ResultsAt Week 52, patient-level SGIC responder and group-level SGIC analyses favored cipa+mig compared with alg+pbo across all SGIC domains (e.g. 90 vs. 59% responders in the cipa+mig vs. the alg+pbo group for SGIC ability to move around; P = 0.0005; and LS mean difference 0.385; P = 0.02). Similarly, PROMIS Physical Function and Fatigue domains numerically favored cipa+mig in both analyses (e.g. 50 vs. 40% responders in the cipa+mig vs. alg+pbo arm for PROMIS Physical Function; P = 0.37; and LS mean difference 3.1; P = 0.11). R-PAct for both treatment groups was similar in the patient-level responder analysis, but numerically favored alg+pbo in the group-level analysis (35% responders in both arms; P = 0.95; and LS mean difference −0.8; P = 0.48). Self-care, usual activities, and depression/anxiety domains of EQ-5D-5L numerically favored cipa+mig in both analyses (e.g. 20 vs. 12% responders in the cipa+mig vs. alg+pbo arm for EQ-5D-5L self-care; P = 0.54; and LS mean difference −0.108; P = 0.52).ConclusionsOverall, switching treatment from alglucosidase alfa to cipa+mig positively impacted PRO measurements during the double-blind period of PROPEL.Trial registrationNCT03729362; Registration date: November 1, 2018; https://clinicaltrials.gov/study/NCT03729362

Non-attendance in randomized remote mental health clinical trial during the COVID-19 pandemic

During the COVID-19 pandemic, a significant increase in psychiatric symptoms was found among essential service professionals (professionals or interns from the health and educational sector) who were exposed to high-risk contamination areas. These symptoms impair functionality, impacting quality of life, work, autonomy, and relationships. Recent data show that brief interventions are effective; however, between 20 and 30% of those individuals often do not attend their scheduled appointments. This study aimed to identify variables related to non-attendance for remote telepsychotherapy among participants with COVID-19-related emotional distress compared to those who initiated treatment. We included 2097 essential service professionals with PROMIS (Patient-Reported Outcomes Measurement Information System) T-scores ≥70 for anxiety, depression, or irritability who scheduled a remote mental health appointment. Participants completed clinical and sociodemographic data, mental health risk and protective factors, and PROMIS subscales. We conducted a binary logistic regression, using attendance vs. non-attendance as the dependent variable and these demographic and clinical characteristics as independent variables. Of the 2097 participants, 230 (11%) did not attend the first session despite three rescheduling attempts. Non-attendance was associated with the presence of irritability and seeking treatment during the second COVID-19 wave. In contrast, anxious symptoms, older age, and coping mechanisms that typically include intellectual and reading activities were associated with attendance. Our findings shed light on non-attendance patterns in mental health services, revealing that personal characteristics and environmental factors significantly contribute to missed appointments. Understanding these dynamics can improve patient engagement and adherence to mental health treatments, particularly in the context of telepsychotherapy during the COVID-19 pandemic.

Symptom Screening Linked to Care Pathways for Pediatric Patients With Cancer

Pediatric patients with cancer commonly experience severely bothersome symptoms. The effectiveness of routine symptom screening with symptom feedback and symptom management care pathways is unknown. To determine whether thrice-weekly symptom screening with symptom feedback and management care pathways, compared with usual care, improves overall self-reported symptom scores measured by the Symptom Screening in Pediatrics Tool (SSPedi) in pediatric patients with cancer. This cluster randomized trial enrolled participants between July 2021 and August 2023 from 20 pediatric cancer centers in the US. Patients newly diagnosed with cancer aged 8 to 18 years receiving any cancer treatment were included. Twenty sites were randomized to provide symptom screening (n = 10) vs usual care (n = 10); 221 participants were enrolled at intervention sites and 224 participants at control sites. The date of final follow-up was October 18, 2023. Symptom screening included providing thrice-weekly symptom screening prompts to participants, email alerts to the health care team, and locally adapted symptom management care pathway implementation. The primary outcome was self-reported total SSPedi score at week 8 (range, 0-60; higher scores indicate more bothersome). Secondary outcomes were Patient-Reported Outcomes Measurement Information System Fatigue score (mean [SD] score, 50 [10]; higher scores indicate more fatigue), Pediatric Quality of Life 3.0 Acute Cancer Module scores (range, 0-100; higher scores indicate better health), symptom documentation and interventions at week 8, and unplanned health care encounters. A total of 445 participants (median [range] age, 14.8 [8.1-18.9] years; 58.9% males) were enrolled. The mean (SD) 8-week SSPedi score was 7.9 (7.2) in the symptom screening group vs 11.4 (8.7) in the usual care group. Symptom screening was associated with significantly better 8-week total SSPedi scores (adjusted mean difference, -3.8 [95% CI, -6.4 to -1.2]) and less bothersome individual symptoms, with 12 of 15 symptoms being statistically significantly reduced. There was no difference in fatigue or quality of life. The mean (SD) number of emergency department visits was 0.77 (1.12) in the symptom screening group and 0.45 (0.81) in the usual care group. There were significantly more emergency department visits in the symptom screening group (rate ratio, 1.72 [95% CI, 1.03-2.87]). Symptom screening with symptom feedback and symptom management care pathways was associated with improved symptom scores and increased symptom-specific interventions. Future work should integrate symptom screening into routine clinical care. ClinicalTrials.gov Identifier: NCT04614662.

Designing a Measure of Body Image: Cognitive Interview Findings from an Adolescent and Young Adult Cancer Sample.

Purpose: A cancer diagnosis in adolescence and young adulthood significantly impacts a person's quality of life, particularly concerning identity, self-esteem, and subsequently, body image. This study aims to develop a psychometrically-sound patient-reported outcome measure of body image for adolescent and young adult (AYA) oncology patients that was guided by the National Institutes of Health's Patient-Reported Outcomes Measurement Information System® (PROMIS) Scientific Standards and our past concept elicitation interviews with AYAs. Methods: We conducted a multi-step approach involving item identification, refinement, generation; translatability and reading level review; and cognitive interviews. A purposive sample of 25 AYA patients participated, ensuring representation across educational levels, gender, treatment status, and cancer type. Results: Translatability and reading level reviews facilitated language adjustments. Cognitive interviews revealed that 76% of AYAs found the 50 candidate items assessing body image concerns to be easy to answer. AYAs reported that the body image items captured their lived experiences. Three items were excluded due to comprehension difficulties. Conclusion: This study addresses the critical gap in validated measures for assessing body image in AYA oncology patients. Interview findings provided evidence for the content validity and comprehensibility for 47 items assessing body image. The next steps involve large-scale psychometric testing to evaluate the reliability and validity of the body image items to form an item bank allowing the design of short forms or use of computerized-adaptive testing. Ultimately, this work lays the foundation for developing interventions to mitigate the impact of cancer on AYAs' body image during diagnosis, treatment, and recovery.

Academic Physician and Trainee Occupational Well-Being by Sexual and Gender Minority Status

Few studies have explored the association between sexual and gender minority (SGM) status and occupational well-being among health care workers. To assess the prevalence of burnout, professional fulfillment, intent to leave, anxiety, and depression by self-reported SGM status. This cross-sectional survey study collected data from October 2019 to July 2021, from 8 academic medical institutions participating in the Healthcare Professional Well-Being Academic Consortium. The survey, including questions on SGM status, was administered to attending physicians and trainees. Statistical analyses were performed from June 1, 2023, to February 29, 2024. SGM status was determined via self-reported sexual orientation and gender identity. Primary outcomes measured were the Professional Fulfillment Index (burnout and professional fulfillment), intent to leave, and self-reported anxiety and depression using the Patient-Reported Outcomes Measurement Information System short-form 4-item measure. Of 20 541 attendings and 6900 trainees, 8376 attendings and 2564 trainees responded and provided SGM status. Of these respondents, 386 attendings (4.6%) and 212 trainees (8.3%) identified as SGM. Compared with their non-SGM peers, SGM attendings had a lower prevalence of professional fulfillment (133 of 386 [34.5%] vs 3200 of 7922 [40.4%]) and a higher prevalence of burnout (181 of 382 [47.4%] vs 2791 of 7883 [35.4%]) and intent to leave (125 of 376 [33.2%] vs 2433 of 7873 [30.9%]) (all P < .001). Compared with their non-SGM peers, SGM trainees had a lower prevalence of professional fulfillment (63 of 211 [29.9%] vs 833 of 2333 [35.7%]) and a higher prevalence of burnout (108 of 211 [51.2%] vs 954 of 2332 [40.9%]) (both P < .001). After adjusting for age and race and ethnicity, SGM attendings had higher odds of burnout than their non-SGM peers (adjusted odds ratio, 1.57 [95% CI, 1.27-1.94]; P < .001). Results for burnout were similar among the SGM trainees compared with their non-SGM peers (adjusted odds ratio, 1.47 [1.10-1.96]; P = .01). In this cross-sectional survey study of academic physicians and trainees, SGM attendings and trainees had higher levels of burnout and lower levels of professional fulfillment. SGM attendings had greater intent to leave than their non-SGM peers, but trainees did not. These disparities represent an opportunity for further exploration to retain SGM health care workers.

Mental Health of Pediatric Patients with Cystic Fibrosis after 18 Months on Elexacaftor-Tezacaftor-Ivacaftor Therapy.

Research studies are conflicting regarding new highly effective modulators and the association with mental health symptoms for adults and adolescents with cystic fibrosis (CF). For younger children, small studies and case reports indicate a wide range of effects, ranging from improvement in mood to the development of neuropsychiatric symptoms. However, a large placebo-controlled study indicated no causal connection. This study evaluates the frequency and severity of mental health symptoms in children and adolescents while taking elexacaftor/tezacaftor/ivacaftor (ETI). The study includes 81 pediatric patients with CF followed at Nationwide Children's Hospital (NCH). Patient Reported Outcomes Measurement Information System (PROMIS)-Anxiety and Depression, Patient Health Questionnaire 8 (PHQ-8) and Generalized Anxiety Disorder Questionnaire (GAD-7) were used to screen for depression and anxiety. Age-appropriate questionnaires were completed over the first 18 months after initiating ETI. At baseline, majority of participants reported mental health symptoms within normal limits (WNL). For participants with elevated baseline measures, depressive and anxiety symptoms significantly decreased throughout the study period. Depending on the metric, patients experiencing depressive and anxiety symptoms dropped to 2-3% (n = 1, on each depressive measure) and 0% (n = 0, on either anxiety measures) respectively by 18 months. Most pediatric patients with CF did not endorse symptoms of depression or anxiety disorders at ETI initiation. Over the first 18 months of ETI usage, the percentage of patients with these symptoms decreased, suggesting that the percentage of patients experiencing severe symptoms of depression and anxiety may decrease with ongoing use of ETI.

QOL-12. ELECTRONIC ASSESSMENT OF QUALITY OF LIFE IN GLIOBLASTOMA PATIENTS USING THE EORTC-QLQ-C30/ EORTC-BN20 AND THE PROMIS SYSTEM IN CLINICAL PRACTICE

Abstract BACKGROUND Patient reported outcomes are essential to guide patient-care and to maintain quality of life. We aim to further assess feasibility of computer adaptations of the Patient-Reported Outcomes Measurement Information System (PROMIS) questionnaire in the clinical setting and compare it with outcomes of the EORTC- QLQ-C30 and EORTC-BN20 questionnaires. METHODS Newly diagnosed patients with GBM were enrolled to assess feasibility. The PROMIS modules were selected to reflect the HRQoL domains assessed in the EORTC- QLQ-C30 and EORTC-BN20 questionnaires. PROMIS modules selected included anxiety, depression, fatigue, physical function, sleep disturbance, sleep-related impairment, social satisfaction role, applied cognitive ability and global health. EORTC instruments as well as PROMIS was answered to patients in the outpatient setting. Descriptive analysis was performed RESULTS 43 patients with 124 PROMIS/EORTC responses were included in this analysis. 31 patients completed the survey prior to or within 14 days of start of radiation, 12 patients completed a survey outside of the radiation window, and a total of 60 completed surveys were obtained between both patient groups. The median times to complete the EORTC-QLQ-C30 and the EORTC-BN20 surveys were 4.77 (range=2.05-18.6) and 2.63 (range=1.17- 24.83) minutes respectively. For the PROMIS instruments except global health, the median times to complete different modules ranged from 0.6- 1 minute (range= 0.15-7.77). For global health, the median time was 2.35 minutes (range= 1.02-21.12). Average time to complete all PROMIS questions was 8.65 minutes (range=3.32-66.01). CONCLUSIONS Real-time prospective assessment of the EORTC tools is similar to the PROMIS measures. While most response times were short, the ranges suggest that select patients might struggle. Patients were offered to participate online from home for convenience, but low computer literacy, limited internet access and burden of disease might limit participation.

Performance of the Healthy Aging Brain Care Monitor Self Report in Monitoring Post-Intensive Care Syndrome Among Acute Respiratory Failure Survivors.

To describe the performance of the Healthy Aging Brain Care Monitor Self Report (HABC-M SR) in assessment of post-intensive care syndrome (PICS) among Acute Respiratory Failure ICU survivors. Secondary data analysis of a randomized controlled trial. Patients evaluated by a nurse care coordinator in an out-of-hospital setting. English-speaking adults 18 years old or older who were admitted to the ICU with acute respiratory failure requiring invasive or noninvasive mechanical ventilation for greater than or equal to 24 hours. Patients randomized to the intervention arm of the mobile critical care recovery program, a negative trial testing multidisciplinary care to improve quality of life. HABC-M SR scale was used to assess PICS in the intervention group at ICU discharge, 3, and 6 months post-discharge. Hospital Anxiety and Depression Scale; Pain, Enjoyment of Life, and General Activity Scale; Timed Up and Go; and Patient-Reported Outcomes Measurement Information System sleep scores were obtained at the same time. Mini-Mental State Examination (MMSE) was administered at baseline and 6 months. ICU survivors reported mild PICS symptoms, which improved over 6 months (mean HABC-M SR scores: baseline [8.5, sd 7.6], 3 mo [5.3 mo, sd 6.6 mo], and 6 mo [5.2 mo, sd 6.9 mo; p < 0.001]). HABC-M SR total score had moderate internal consistency that improved over time (Cronbach's alpha = 0.78 at baseline and 0.84 at 6 mo). The psychological subscale of HABC-M SR was moderately correlated with standardized scales for mood, pain, and sleep. The cognitive subscale was not significantly correlated with MMSE. While HABC-M SR correlated with mood, physical, and sleep symptoms, the cognitive subscale was less sensitive compared with standardized scales.

Sexual Health Among Young Adults Treated with Chimeric Antigen Receptor T Cell Therapy: A Mixed-Methods Study.

Purpose: Chimeric antigen receptor T cell therapy (CAR-T) is a breakthrough treatment for hematological malignancies, but sexual health, crucial for quality of life among young adults (YAs) ages 18-39, remains unexplored among YA CAR-T recipients. This study explored sexual health and patient-provider sexual health communication among YAs post-CAR-T. Methods: This cross-sectional mixed-methods study recruited YAs ≤5 years post-CAR-T. Participants completed Patient-Reported Outcomes Measurement Information System measures assessing sexual health and study-specific items assessing patient-provider sexual health communication. A subset completed a semistructured interview exploring the impact of CAR-T on sexual health and patient-provider sexual health communication. Descriptive statistics compared quantitative data to evidence-based thresholds. Qualitative data were thematically analyzed. Results: Fourteen YAs participated; 11 completed interviews. Median age was 33 years (range: 22-39), 64.3% were male, 92.9% were heterosexual, and median time post-CAR-T was 22 months. Interest in sexual activity was low among females (mean [M] = 35.1, standard deviation [SD] = 10.0), and orgasm ability was low among males (M = 39.3, SD = 19.5). Females reported less interest in sexual activity than males. Most YAs had not (50.0%) or did not recall (35.7%) discussing sexual health with a provider pre-CAR-T. Most (78.6%) had not discussed sexual health with a provider post-CAR-T. Three higher level qualitative themes emerged as follows: (1) treatment negatively affected libido, sexual activity, and romantic relationships, (2) YAs face challenges communicating with health care providers about sexual health, and (3) there is limited sexual health education and support for YAs. Conclusion: Findings highlight a need for improved patient-provider communication about sexual health and educational resources for YA CAR-T recipients.

Patients with multiple sclerosis have higher rates of worsening following total hip arthroplasty: a propensity-matched analysis.

The progressive nature of multiple sclerosis (MS) may adversely affect outcomes following total hip arthroplasty (THA). As patient-reported outcome measures (PROMs) in this specific group are not well defined, this study aimed to compare the clinical outcomes and the rates of achieving the minimal clinically important difference for improvement (MCID-I) and worsening (MCID-W) between patients with MS and those without MS undergoing THA. We conducted a retrospective analysis of 375 THAs, including 75 MS patients and 300 propensity-matched non-MS patients (4:1), performed between 2016 and 2022. Collected PROMs included Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Mental and Physical, PROMIS Physical Function short form 10-a (PF-10a), and Hip disability and Osteoarthritis Outcome Score-Physical Function Short-form (HOOS-PS). Preoperative and postoperative PROMs and MCID-I/MCID-W rates were compared. A total of 375 THAs, including 75 MS and 300 matched non-MS patients, were analysed. MS patients had higher 90-day postoperative complication rates (9.3% vs. 2.3%, p = 0.012) and infection rates (4.0% vs. 0.3%, p = 0.006). The rates of achieving MCID-I and MCID-W were similar for PROMIS Global Mental, PROMIS Global Physical, and HOOS-PS, but MS patients had a higher rate of experiencing MCID-W for PROMIS PF-10a compared to non-MS patients (16.7% vs. 6.5%, p = 0.022). Additionally, MS patients had a longer mean hospital stay (2.4 vs. 1.9 days, p = 0.005) and lower rates of being discharged home (82.7% vs. 94.3%, p < 0.001). The present study found that MS patients experience similar rates of MCID-I and MCID-W in most PROMs but have a higher rate of MCID-W for PROMIS PF-10a and increased postoperative complications. These findings highlight the need for careful consideration of postoperative risks despite potential improvements. Further research is needed to explore the impact of MS progression on PROMs and perioperative outcomes.

Benign Evolution of Complex Regional Pain Syndrome (CRPS) Type 1 in Patients Treated with Intravenous Neridronate: A Single-Center Real-Life Experience.

To investigate the long-term effects of intravenous neridronate treatment in patients with complex regional pain syndrome type 1 (CRPS) in a real-life setting. We conducted a retrospective study on consecutive CRPS patients treated at our hospital from February 2018 to July 2023. All were treated within three months of the onset of CRPS symptoms. The Patient-Reported Outcomes Measurement Information System 29-Item Health Profile (PROMIS-29) version 2.1 was administered. The main outcome of interest was the evolution of the PROMIS-29 scores from baseline to the last follow-up visit. Patients were categorized as "complete responders" or "non-complete responders". The association of clinical and demographic variables with a complete response was analyzed using chi-square tests and univariate logistic regression. Thirty-six patients were included, with a median follow-up time of 4.8 years. A significant improvement was noted in the mean numerical pain rating scale (from 6.4 ± 1.9 to 3.1 ± 2.4, p < 0.001), as well as across all PROMIS-29 domains. Physical function improved from 34.2 ± 4.9 to 49.2 ± 9.9, p < 0.001; anxiety from 58.0 ± 6.7 to 49.6 ± 6.9, p < 0.001; depression from 55.3 ± 6.3 to 47.7 ± 6.6, p < 0.001; fatigue from 55.7 ± 7.7 to 50.9 ± 8.7, p < 0.001; sleep disturbance from 53.8 ± 6.8 to 51.3 ± 6.6, p = 0.034; social roles and activities from 41.8 ± 5.2 to 51.8 ± 8.9, p < 0.001; and pain interference from 64.1 ± 5.9 to 52.4 ± 9.9, p < 0.001. The likelihood of achieving a complete response was associated with the male sex, foot or ankle injuries (compared to hand and wrist injuries), and a younger age. No association was found with the type of inciting event or with the body mass index. Our real-life data indicate that early treatment with neridronate leads to substantial benefits in patients affected by CRPS type 1. The strongest responses are seen in young patients, males, and those with lower limb involvement.

Social Pain Minimization Mediates Discrimination’s Effect on Sleep Health

ABSTRACT Objective Discrimination disrupts sleep and contributes to race-based health inequities for Black Americans, but less is known about the psychological mechanisms underlying this relation. The current work tests whether emotion invalidation, termed Social Pain Minimization (SPM), mediates discrimination’s negative effects on sleep quality. We focus on the experiences of Black Americans because of racism’s disproportionate effect on the health outcomes of Black individuals in the U.S. Methods Four studies with cross-sectional (Studies 1a-1b) and cross-lagged panel designs (Studies 2–3; N total = 1,176) were used. Discrimination and SPM were assessed with established measures and self-reported sleep quality was assessed with three different operationalizations including the short form Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep-Related Impairment (SRI) subscale and composites of the Insomnia Severity Index (ISI). Results Cross-sectional (Studies 1a-1b) and longitudinal mediation analyses (Studies 2–3) indicated discrimination’s negative effect on sleep quality partially operated through SPM (Study 1a, 95% CI = [−.24, −.016]); Study 1b, 95% CI = [−.22, −.03]; Study 2, 95% CI = [−.268, −.007]]; Study 3, 95% CI = [−0.043, −.002]). Conclusion Beyond its direct negative effect on sleep, discrimination also operates through SPM to reduce sleep quality. Emotion invalidation stemming from discrimination damages sleep.

Defining Clinically Significant Outcome Thresholds for the Patient-Reported Outcomes Measurement Information System (PROMIS) at 2 Years After Gluteus Medius and/or Minimus Repair.

Clinically significant outcome (CSO) thresholds are invaluable to the interpretation of patient-reported outcomes (PROs). The Patient-Reported Outcomes Measurement Information System (PROMIS) is gaining popularity among the orthopaedic community; however, CSO thresholds for PROMIS are yet to be defined for outcomes after gluteus medius and/or minimus (GM) repair. To (1) define CSO thresholds for PROMIS-Pain Interference (PROMIS-PI) and PROMIS-Physical Function (PROMIS-PF) after GM repair, (2) correlate these PROMIS scores with legacy hip-specific PROs, and (3) quantify their floor and ceiling effects. Case series; Level of evidence, 4. Consecutive patients who underwent primary GM repair between September 2017 and June 2021 with completed PROMIS at minimum 2-year follow-up were evaluated. The minimal clinically important difference, Patient Acceptable Symptom State, and substantial clinical benefit thresholds were defined for the PROMIS-PI and PROMIS-PF as well as for legacy PROs: Hip Outcome Score-Activities of Daily Living (HOS-ADL) and Hip Outcome Score-Sports Subscale (HOS-SS); modified Harris Hip Score (mHHS); 12-item International Hip Outcome Tool (iHOT-12); and the visual analog scale (VAS) for pain and satisfaction. Pearson correlations were performed between PROMIS scores and legacy PROs. Rates of floor and ceiling effects were quantified. Overall, 107 patients (81.7% follow-up compliance; mean age, 59.8 ± 8.8 years; 92.5% female; mean body mass index, 28.6 ± 6.3 kg/m2) were included in the analysis. GM tears were partial thickness in 56.1% of cases and treated endoscopically in 64.5% of cases. The minimal clinically important difference, Patient Acceptable Symptom State, and substantial clinical benefit thresholds, respectively, were as follows: PROMIS-PI (-4.6, 56.0, 52.6), PROMIS-PF (3.5, 42.7, 43.7), HOS-ADL (10.7, 68.2, 78.6), HOS-SS (16.5, 58.6, 60.6), mHHS (9.0, 64.3, 71.5), iHOT-12 (14.2, 63.6, 69.4), VAS pain (-16.1, 34.9, 28.1), and VAS satisfaction (not applicable, 70.9, 93.6). Moderate to strong correlations were observed between the PROMIS and legacy PROs. The PROMIS-PI showed a significant postoperative floor effect of 18.7%. Study findings indicated that the PROMIS is effective for use in GM repair patients, given the moderate-to-strong correlations between the PROMIS and legacy hip-specific PROs, the mostly limited floor and ceiling effects, and large effect sizes. Use of PROMIS instead of legacy PROs may aid in limiting survey burden.

The Preoperative Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Global Mental Health T-Score: An Independent Predictor of Immediate Post-Surgical Outcomes Following Elective Total Knee Arthroplasty

BackgroundMental illness is a known risk factor for poor postoperative outcomes following total knee arthroplasty (TKA); however, a diagnosed mental illness does not always reflect the current state of a patient’s mental health. Using the preoperative Patient-Reported Outcomes Measurement Information System (PROMIS)-10 Mental Health T-score (MHT), the purpose of this study was to understand the association between mental health and a patient’s immediate inpatient recovery pattern following TKA. MethodsThis was a retrospective study of patients undergoing elective primary TKA. Patients were grouped based on their MHT score (Above Average [AA] > 50, Average [A] 40 to 50, Below Average [BA] < 40). Postsurgical parameters included inpatient opioid consumption, pain reporting, functional measures, and discharge disposition. ResultsA total of 2,740 patients were included in this study (AA 55.8%, A 35.4%, BA 8.8%). Multivariate modeling demonstrated that an MHT score below 40 was an independent risk factor for opioid consumption, pain reporting, discharge disposition, ambulation distance, and timed-up-and-go performance. A diagnosed mental illness was not associated with poor outcomes. ConclusionThe MHT can be used as a preoperative screening tool that can identify an at-risk group not previously described. An MHT< 40 was associated with poor immediate postoperative outcomes.

Does the Use of a Tourniquet Influence Five-Year Outcomes Following Total Knee Arthroplasty?

BackgroundA tourniquet is commonly used during total knee arthroplasty (TKA) to improve surgical field visibility and minimize blood loss. While the short-term effects of tourniquet use on postoperative outcomes have been studied extensively and found to be minimal, its influence on longer-term outcomes remains underexplored. This study examined tourniquet use in TKA with up to five-year follow-up. MethodsIn this post hoc analysis of a randomized controlled trial, 227 patients who underwent primary TKA in the tourniquet (T) group (n = 112) or no tourniquet (NT) group (n = 115) were evaluated. Clinical outcomes and patient-reported outcome measures (PROMs) were compared between the two groups. ResultsThe T group had non-significant trends toward reduced blood loss (131.8 versus 116.7 ml, P = 0.098) and shorter operative time (97.8 versus 95.7 minutes, P = 0.264), with slightly higher postoperative day-one Visual Analog Scale (VAS) pain scores (3.1 versus 3.6, P = 0.197). Length of stay (2.0 versus 2.1 days, P = 0.837) and home discharge rate (88.7 versus 92.0%, P = 0.340) were comparable. The NT group had three 90-day readmissions, while none occurred in the T group (2.7 versus 0%, P = 0.081). The active range of motion at the final follow-up was similar between groups (108.3 versus 106.5 degrees, P = 0.457). All-cause revision rates at five years were comparable between the NT and T groups (5.2 versus 3.6%, P = 0.546). Kaplan-Meier survivorship analysis revealed comparable aseptic implant survival at five years (P = 0.769). There were no significant differences in Knee injury and Osteoarthritis Outcome Score for Joint Replacement (KOOS, JR), Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity, PROMIS pain interference, or PROMIS physical health scores at three months, one year, and five years postoperatively. ConclusionUsing a tourniquet during primary TKA was not associated with differences in clinical or patient-reported outcomes at up to five-year follow-up. These findings suggest that tourniquet use in TKA can be left to the surgeon’s discretion.

Secondary causal mediation analysis of a pragmatic clinical trial to evaluate the effect of chiropractic care for US active-duty military on biopsychosocial outcomes occurring through effects on low back pain interference and intensity

ObjectiveWe evaluate change in low back pain (LBP) intensity and interference as the mechanism by which chiropractic care affects other biopsychosocial factors in US active-duty military members.DesignWe conducted secondary, exploratory...