Search Results (135)

Patient-reported outcomes (PROs) are an integral component of contemporary oncology. They provide direct insight into symptom severity, treatment tolerability, and health-related quality of life. Despite their clinical relevance, routine implementation faces several hurdles. Key limitations include patient survey fatigue, challenges in real-time interpretation of complex symptom trajectories, and incomplete longitudinal data that limit reliable analysis. This narrative review summarizes recent advances (2020–2026) in applying artificial intelligence (AI) to structured questionnaires, including EORTC QLQ-C30, PROMIS, and PRO-CTCAE, as well as to unstructured clinical text. Machine learning and natural language processing may enhance the clinical utility of PROs through automated analysis, symptom extraction, and predictive modeling. Current studies suggest that AI-based approaches can support the prediction of symptom deterioration, treatment-related toxicity, and healthcare utilization, including unplanned hospitalizations and emergency department visits. Furthermore, NLP models can extract clinically meaningful information from free-text narratives. We also discuss emerging non-invasive digital biomarkers derived from speech and facial expressions. Multimodal approaches suggest that these features may provide complementary indicators of pain, fatigue, and affective state. Overall, AI has the potential to transform PROs from static assessment tools into dynamic clinical instruments. This shift may enable more continuous and proactive symptom monitoring and support the integration of multimodal patient data into oncology decision-making workflows. Full article

Background: Systemic lupus erythematosus (SLE) is associated with an increased burden of cardiovascular disease (CVD), driven by dyslipidemia, hypertension, obesity, inflammation, and treatment. These factors can impact patient quality of life (QoL) by limiting physical activity. Objectives: To characterize lipid abnormalities as CVD risk factors in a Saudi SLE cohort and assess associations between lipid profile, SLE features, treatment, and patient-reported outcomes of physical activity. Methods: A cohort of adult SLE patients followed at King Saud University Medical City since 2021 was analyzed. Demographics, lipid profiles, blood pressure, BMI, SLEDAI-2K, SDI, disease duration, and treatment data were collected. Physical function and quality of life were assessed using the LupusQoL and PROMIS Physical Function T scores. Univariate and multivariate logistic regression analyses were conducted to identify associations between lipid abnormalities, SLE-related factors, and QoL physical activity measures. Results: A cohort of 169 patients (88.2% female, mean age 39.3 ± 12.4 years) was evaluated to assess the presence of dyslipidemia (23.7%), obesity (BMI ≥ 25, 66.3%), and hypertension (≥130/80 mmHg, 26.0%). Mean SLE duration was 9.2 ± 7.7 years and mean SLEDAI-2K was 11.0 ± 7.0. Among these patients, 52.7% used steroids, 88.2% used antimalarial drugs, and 53.8% used immunosuppressives. Dyslipidemia was associated with lower LupusQoL physical scores (adjusted OR 0.986; 95% CI 0.972–1.000; p = 0.0446). No significant associations were found between lipid levels and the PROMIS Physical Function T score. Conclusions: In this Saudi SLE cohort, dyslipidemia and other modifiable CVD risks were common. Dyslipidemia correlated with poorer LupusQoL-specific physical scores, which highlights the importance of lifestyle changes in patients with SLE. Full article

Background/Objectives: The aim of this pilot study was to evaluate the feasibility of developing individualized machine learning models using nocturnal wearable-derived autonomic nervous system (ANS) and sleep metrics to predict next-day headache risk in patients with migraine. We also examined the associations between nocturnal ANS and sleep measures and patient-reported outcome measures (PROMs) related to nociplastic pain, migraine burden, and non-restorative sleep (NRS). Methods: Adults with migraine wore the wrist-worn Empatica EmbracePlus^® wearable during sleep and completed daily headache diaries for approximately 4 weeks (N = 10). Participants also completed daily headache diaries and PROMs assessing nociplastic pain, migraine burden, and non-restorative sleep. Personalized machine learning (ML) models were developed to predict next-day headache using nocturnal ANS activity (e.g., pulse rate variability (PRV), electrodermal activity (EDA), respiratory rate (RR)) and sleep metrics (e.g., interruptions, duration, awakenings). Model performance was evaluated using area under the receiver operating characteristic and precision–recall curves (AUROC, AUPRC), sensitivity, specificity, accuracy, and precision. Spearman correlations assessed the relationship between wearable-derived metrics and patient-reported outcome measurements of sleep quality (PROMIS-Fatigue, PROMIS-Sleep Disturbance) and a surrogate marker of nociplastic pain (Fibromyalgia (FM) Score). Results: 9 out of 10 participants wore the EmbracePlus device for at least the target duration of four weeks. For the next-day headache prediction, model performance varied between individuals; area under the ROC curve (AUROC) ranged from 28.2% to 81.2%. Nocturnal measures of EDA were strongly correlated with the FM score (Spearman’s rho = 0.72–0.75, p < 0.05). Conclusions: Phasic EDA may warrant further investigation as a potential physiological indicator related to nociplastic pain mechanisms and next-day headache. However, these findings are preliminary, and larger multicenter trials are needed to confirm results of this pilot study. Full article

Background/Objectives: Age-related musculoskeletal (MSK) disorders lead to pain, reduced function, and diminished quality of life. This study aimed to evaluate the impact of a virtually delivered MSK care program on pain and function in older adults. Methods: A single-arm pre–post study was conducted analyzing self-reported outcomes of 902 patients aged ≥ 65 years who completed an initial evaluation with both an MSK specialty physician/nurse practitioner and a physical therapist, followed by two or more clinical visits. Outcome measures included pain (NPRS), function (SANE and PROMIS-10 GPH), and mental health (GAD-2, PHQ-2, and PROMIS-10 GMH). Results: Across 891 patients, mean pain intensity decreased from 4.56 ± 0.07 to 2.30 ± 0.07 (49.6%, p < 0.001) with 693 patients (77.8%) experiencing pain relief (63.2%, p < 0.001). In 172 patients with severe baseline pain (NPRS ≥ 7), 91.3% reported decreased pain (60.9%, p < 0.001). Functional gains were clinically meaningful, with SANE scores increasing from 53.85 ± 0.90 to 76.62 ± 0.75 (n = 795, 42.3%, p < 0.001). Pain reduction correlated with functional improvement (ρ = −0.29, p < 0.001) with modest correlations between engagement and improved pain (ρ = −0.09) and function (ρ = 0.23). Mental health outcomes remained stable, with marked improvement among patients with baseline symptoms of anxiety or depression, 44.2% and 57.1%, respectively. Conclusions: The virtual MSK care program produced meaningful improvements in pain and function while maintaining overall health. This highlights the potential for virtual MSK-focused integrated practice units (IPUs) to support holistic well-being and healthy aging in older adults. Full article

Background/Objectives: Adolescents and young adults (AYAs) with inflammatory bowel disease (IBD) experience persistent physical symptoms and psychosocial challenges that can impair functioning and quality of life. Health mindset, beliefs about whether health is fixed versus malleable and responsive to effort, is linked to positive health outcomes but has not been examined in AYAs with IBD. This study evaluated the internal reliability of a health mindset measure in AYAs with IBD and examined associations between health mindset and depressive symptoms, peer relationships, global health, pain interference, fatigue, and disease activity. Methods: Participants were 101 AYAs with IBD (M = 18.4 years; 54.4% ulcerative colitis; 63.4% female) recruited from an outpatient pediatric IBD clinic and a national IBD network. Participants completed a one-time online survey consisting of the Health Mindset Scale, Patient-Reported Outcomes Measurement Information System (PROMIS) measures for physical, psychosocial, and global health outcomes, and IBD disease activity indices. Results: The Health Mindset Scale demonstrated good internal reliability in this sample. Additionally, a growth health mindset was significantly associated with lower pain interference, lower Crohn’s disease activity, and better global health. No significant associations were observed between health mindset and depressive symptoms, peer relationship quality, fatigue, or ulcerative colitis disease activity. Conclusions: This novel study provides initial evidence that health mindset is associated with clinically meaningful outcomes in AYAs with IBD. These findings highlight that health mindset may be an important psychological construct in chronic illness adjustment and management, extending mindset theory and research to a young clinical population with IBD. Full article

Heavy episodic drinking (HED) is prevalent in young adulthood, yet its relationship with psychosocial well-being remains complex. This study examines the association between HED and perceived social isolation among young adults and tests whether this relationship varies by sexual orientation. Using pooled, nationally representative data from the 2022 and 2024 Health Information National Trends Survey (HINTS), this study analyzed adults aged 18–29 (N = 723). Perceived social isolation was measured using the PROMIS Social Isolation Short Form. Weighted multivariable linear regression models assessed interactions between sexual orientation and HED occasions (0 vs. 1+), adjusting for sociodemographic variables and psychological distress. 45.5% reported HED. Lesbian/gay (B = 5.62, SE = 0.58, p < 0.001) and bisexual (B = 1.66, SE = 0.34, p < 0.001) young adults reported higher isolation than straight peers; HED was inversely associated with isolation (B = −1.71, SE = 0.20, p < 0.001). A significant interaction indicated that among lesbian/gay young adults, heavy drinking was associated with lower perceived isolation (B = −5.77, SE = 0.98, p < 0.001). Interventions should account for the social meanings of alcohol use to avoid unintentionally increasing isolation among sexual minoritized populations. Full article

Background: The Patient–Reported Outcomes in Parkinson’s Disease (PRO-PD) scale is a 35-item visual analog measure designed to quantify symptom severity across motor and non-motor domains. Developed as a continuous, patient-centered outcome, PRO-PD captures patient-perceived change over time and is suitable for remote longitudinal assessment. This study evaluated the psychometric properties of PRO-PD across two independent datasets, including reliability, validity, factor structure, and minimal clinically important difference (MCID), and assessed its relevance to nutrition- and lifestyle-focused research. Methods: Convergent validity was evaluated in a cross-sectional clinical dataset (n = 46) using established clinician-rated and patient–reported instruments, including Hoehn and Yahr, Unified Parkinson’s Disease Rating Scale (UPDRS), Parkinson’s Disease Questionnaire-39 (PDQ-39), Montreal Cognitive Assessment (MoCA), and PROMIS measures. Internal consistency, temporal stability, factor structure, and known-groups validity were assessed in a large remote-monitoring cohort (n = 2612). MCID thresholds were estimated in a longitudinal subsample (n = 390) using anchor-based methods, multinomial regression, and receiver operating characteristic analyses. Results: PRO-PD demonstrated strong convergent validity with established clinical measures, excellent internal consistency (Cronbach’s α = 0.93 (95% CI: 0.90–0.96) for Small Data and 0.95 (95% CI: 0.947–0.951) for Big Data”), and good test–retest reliability (ICC = 0.78 overall; 0.89 at 6 months). Confirmatory testing of a previously proposed eight-factor structure showed suboptimal fit, leading to a parsimonious four-factor solution (Neurobehavioral, Autonomic, Motor, Mood/Motivation) explaining 47.6% of variance. PRO-PD scores increased significantly with advancing disease duration and stage. MCID thresholds were +53.5 points for worsening and −78.5 points for improvement (AUC = 0.64 for worsened vs. not worsened; AUC = 0.71 for improved vs. worsened), with greater sensitivity for detecting deterioration than improvement. PRO-PD scores demonstrated sensitivity to patient-perceived symptom change over time, supporting its utility for longitudinal monitoring and potential application in lifestyle-focused intervention research. Conclusions: These findings support PRO-PD as a psychometrically robust outcome measure that can be completed remotely without trained administrators. Full article

Background: Disorders of the gut–brain interaction (DGBIs) constitute a group of functional conditions widely described in adults; however, some of these have not been included in pediatric Rome criteria, despite the fact that they may manifest during childhood. Early identification of these conditions is relevant due to their clinical/psychosocial impact as well as their effect on quality of life. The aim was to determine the prevalence and associated factors of some DGBIs described in adults according to the Rome IV criteria in pediatric population. Methods: An observational/prospective/cross-sectional study was conducted in toddlers, school-aged children, and adolescents from three Colombian cities. The adapted Questionnaire for Pediatric Gastrointestinal Symptoms Rome IV (QPGS-IV) using adult criteria was applied, along with quality-of-life scales and PROMIS for anxiety/depression. Descriptive uni/bivariate analyses were performed as well as a multivariate logistic regression model. Results: A total of 704 participants were included (13.7 ± 2.8 years old). The prevalence of DGBIs described in adults according to QPGS-IV was 5.8%, with proctalgia fugax being the most frequent. In the bivariate analysis, race, school/social absenteeism, depressive traits, and impaired quality of life were significantly associated. In the multivariate model depressive traits (OR = 4.08; 95%CI = 1.82–9.12; p = 0.001), school (OR = 2.51; 95%CI = 1.06–5.98; p = 0.036), and social absenteeism (OR = 4.04; 95%CI = 1.70–9.62; p = 0.002) were the factors independently associated. Conclusions: These adult DGBIs, according to the QPGS-IV, can occur in pediatric populations and are closely related to psycho-emotional and functional factors. These are mainly associated with depression and school/social absenteeism, supporting the need for a biopsychosocial approach and a revision of the pediatric diagnostic criteria. Full article

Background: Hand burns are common in children and can result in long-term functional impairment. The Hand Burn Severity (HABS) score is an anatomy-specific measure of hand burn severity, but its relationship to functional outcomes in pediatric patients has not been well defined. The purpose of this study was to determine whether HABS, measured at the time of injury, is associated with longitudinal upper extremity functional outcomes in children. Methods: We conducted a 24-month prospective longitudinal study of children aged 2–18 years with hand burns. Burn severity was determined using HABS at enrollment, and outcomes were measured using the Burn Outcomes Questionnaire (BOQ) and the eight-item Patient-Reported Outcomes Measurement Information System-Upper Extremity (PROMIS-UE8). Repeated-measures linear regression models evaluated associations between HABS and outcomes over time, adjusting for age, dominant- and bilateral-hand involvement, and surgery. Results: A total of 119 children with 165 hand burns were enrolled. Higher HABS scores, indicating more severe injury, were significantly associated with lower BOQ upper extremity function domain scores, indicating poorer health, at 2- and 6-months post burn, but not at later time points. Higher HABS scores were independently associated with lower patient-reported PROMIS-UE8 scores, indicating poorer health, across the 2-year follow-up period. Conclusions: These findings indicate that higher HABS scores at the time of injury are associated with poorer upper extremity outcomes, particularly in the early post-burn period, suggesting that HABS may help identify children who could benefit from closer monitoring or early rehabilitation planning. Full article

Facial gender-affirming surgery (FGAS) is a transformative step for transgender individuals in their gender care journey. Even so, the way outcomes are measured and reported is highly inconsistent and unstudied. This limits the ability to compare studies or develop clear, patient-centered benchmarks for success. We systematically assess how current research defines FGAS outcomes and lay the groundwork for a unified Core Outcome Set (COS). A systematic review was conducted following the PRISMA 2020 guidelines. PubMed was searched up to 15 March 2025; we identified 334 studies, and four reviewers independently screened the studies. After screening, 207 studies met the inclusion criteria, encompassing 30,937 patients. Data on study characteristics, surgical procedures, outcome domains, measurement tools, and follow-up duration were extracted. Descriptive statistics and chi-square analyses were used to evaluate reporting trends. Most studies emphasized aesthetic outcomes (60.56%) and complications (62.44%); fewer addressed psychosocial well-being (43.19%), quality of life (35.21%), or reoperation rates (21.60%). Only 26 of the 207 studies used validated outcome instruments, such as FACE-Q or PROMIS (p < 0.001). Among studies that reported satisfaction, only 41.2% provided numerical or stratified scores. Outcome reporting in FGAS research is fragmented and dominated by subjective or unvalidated assessments. A standardized COS is needed to unify research practices, facilitate meaningful comparisons, and ensure that outcomes align with patient-defined measures of surgical success. Full article

Marijuana use in the United States (U.S.) has diversified alongside expanding legalization, yet little is known about the psychosocial factors that distinguish medical from recreational use. This study examined whether psychological distress mediates the association between perceived social isolation (i.e., loneliness) and marijuana use type among U.S. adults. We analyzed cross-sectional, nationally representative data from the 2024 Health Information National Trends Survey (HINTS, cycle 7). Marijuana use was categorized as medical (including medical and both medical/recreational) versus recreational. Perceived social isolation was measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) Social Isolation t-score, and psychological distress was assessed with the Personal Health Questionnaire (PHQ)-4. Survey-weighted descriptive analyses and a weighted structural equation mediation model accounting for the complex sampling design were conducted. Medical marijuana users reported significantly higher levels of psychological distress and perceived social isolation than recreational users. Greater social isolation was strongly associated with higher psychological distress, and higher distress was associated with a greater likelihood of medical (vs. recreational) marijuana use. The indirect effect of social isolation on marijuana use type through psychological distress was statistically significant, while the direct effect of social isolation was not significant after accounting for distress. Overall, greater perceived social isolation predicted medical marijuana use primarily through elevated psychological distress. These findings suggest that medical marijuana use among U.S. adults may reflect coping with psychological distress linked to social disconnection, underscoring the importance of integrating mental health and social context into clinical and public health approaches to cannabis use. Full article

Background and Objectives: Orthopedic patients recovering from lower extremity trauma frequently experience gait disturbances that affect mobility, independence, and quality of life. Engaging patients in recognizing their own gait abnormalities may enhance participation in rehabilitation and improve functional outcomes. The purpose of this study to assess if patients recovering from lower extremity trauma can self-recognize the presence or absence of a gait abnormality, and if the PROMIS physical function scores correlate with gait abnormality. Materials and Methods: An IRB-approved prospective cross-sectional study was conducted at a Level One U.S. trauma center, assessing gait disturbance in patients recovering from lower limb surgery. Participants completed the PROMIS physical function survey along with self-assessing the presence or absence of a limp, then received a clinical gait assessment by a clinician. Of 243 patients screened, only those with an isolated lower limb injury, status post-operative trauma care, and able to ambulate unassisted were included. This yielded a final study cohort of 66 patients. Results: Post-lower extremity trauma patients were able to self-identify the presence (95.92% p < 0.00001) or absence 89.47% (p < 0.00001) of a gait abnormality. There was a statistically significant difference in PROMIS physical function t-scores between patients with and without a limp, 37.2 and 44.4 (p-value 0.00012), respectively. Conclusions: Patients recovering from lower extremity trauma can effectively identify the presence or absence of gait disturbances. Limp recognition was associated with lower PROMIS Physical Function scores. Promoting patient awareness and involvement in tracking their recovery may enhance engagement, guide clinical decision-making, and support better rehabilitation outcomes. Full article

Background/Objectives: There is limited empirical evidence on the feasibility of inclusive, community-based exercise programs for older adults with long-term mobility disabilities. This pilot study investigated the feasibility and preliminary effectiveness of a community-based high-intensity functional training (HIFT) intervention. Methods: This single-group pre–post feasibility trial was delivered across four community-based HIFT facilities. Thirteen participants enrolled, and 10 (mean age 69.8 ± 6.7 years; 60% female) completed baseline assessments, two onboarding sessions, and thrice-weekly group-based workouts across 16 weeks. Physical function was assessed using the Canadian Occupational Performance Measure (COPM), Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function, Modified Falls Efficacy Scale (MFES), and standardized tests of mobility, balance, and strength. Exploratory outcomes included body mass index (BMI), waist circumference, work capacity, and quality of life (QOL). Results: Recruitment, retention, and attendance rates were 38%, 77%, and 58% (80% including make-up sessions), respectively. The intervention was safe and well-tolerated, with one fall-related adverse event. Self-reported functional outcomes demonstrated small to large effects, with large improvements in participant-identified functional activities (d = 1.03–1.54) and fall efficacy (d = 0.97), and a small effect for standardized physical function (d = 0.36) Endurance improved substantially (d = 1.01), while mobility, balance, and strength outcomes reflected maintenance or small to moderate gains (d = 0.08–0.55). BMI remained stable (d = 0.05), work capacity increased with moderate to large effects (d = 0.61–1.43), and QOL improved modestly (d = 0.20). Exit interviews reinforced high acceptability, highlighting individualized adaptations, supportive trainers, and the group-based context as motivating contextual factors. Conclusions: A community-based HIFT program is feasible and acceptable for older adults with mobility disabilities. Full article

Background: Bloating, gas, and abdominal discomfort are common in healthy individuals but lack effective interventions. Probiotics can alleviate some gastrointestinal (GI) symptoms; however, evidence for their impact on bloating, gas and abdominal discomfort in otherwise healthy populations remains limited. Mechanistic studies suggest that synbiotics may influence the underlying mechanisms of bloating, including increased gas production, impaired gut motility, and visceral hypersensitivity, but there is a paucity of data from large trials evaluating clinical outcomes. Accordingly, we evaluated the effects of a multi-species synbiotic on GI symptoms. Methods: In a randomized, double-blind, placebo-controlled, decentralized trial, participants (n = 350) with self-reported bloating/indigestion received either a multi-species synbiotic (53.6 billion AFU multi-species probiotic and 400 mg pomegranate extract; DS-01) or placebo daily for 6 weeks. Outcomes included GI quality-of-life (DQLQ), bloating and gas (PROMIS-GI 13a), abdominal discomfort (PROMIS-GI 5a), constipation, regularity, mood-related symptoms, and safety. Results: The multi-species synbiotic improved GI quality-of-life compared to placebo (0.80 vs. 1.20; p < 0.05) at Week 6. Bloating and gas were reduced in the synbiotic arm compared to placebo (16.0 vs. 21.0; p < 0.01), with more participants reporting never/rarely bloating (72.3% vs. 55.9%; p < 0.001). Abdominal discomfort also decreased (8.0 vs. 10.0; p < 0.01). Additionally, there was a statistically significant improvement in constipation symptoms and regularity in the synbiotic arm relative to placebo. Conclusions: Daily supplementation with this multi-species synbiotic significantly improved GI quality-of-life, bloating, gas, abdominal discomfort, and bowel habits. This is the first synbiotic to demonstrate meaningful improvements in bloating and gas in a generally healthy, diverse, real-world population. Full article

Background: Longitudinal studies demonstrate an association between social media use and anxiety. However, the mechanism of this association in terms of emotional support is not completely understood. Methods: We used survey data among a national sample of 2403 individuals aged 18–30. Primary measures included the 4-item Patient-Reported Outcome Measurement Information System (PROMIS) scale to assess anxiety, self-reported emotional support derived from social media (SMES), and the 10-item Big Five Inventory (BFI-10) to determine personality structure. We performed factorial analysis of variance (ANOVA) and multiple regression analyses to examine the associations among these variables while controlling for age and sex. Results: SMES was associated with decreased anxiety. These associations were more pronounced among females. Personality traits of high openness to experience, high extraversion, high agreeableness, and low conscientiousness were associated with increased SMES. Limitations: Due to the cross-sectional research design and observation data, causal relationship could not be established. Conclusions: Emotional support derived from social media (SMES) may be linked to reduced anxiety, especially among females. SMES may also be linked with specific personality characteristics. Future research should investigate these associations longitudinally. Full article