Patient-Reported Outcomes Measurement Information Research Articles

Методы оценки исходов в клинических исследованиях у пациентов с АНЦА-ассоциированными васкулитам

Immunosuppressive therapy significantly improved survival of patients with ANCA-associated vasculitides (AAV). However, the adverse effects of therapy, particularly glucocorticosteroids, along with the accumulation of organ damage and a deterioration in the quality of life, have become the leading factors contributing to the disease burden. The development of a core outcome set and assessment tools is a current problem of research methodology to improve their quality and uniformity of data. Disease activity and damage assessed by the Birmingham Vasculitis Activity Score (BVAS v.3) and the Vasculitis Damage Index (VDI), respectively, as well as patient-reported outcomes (PRO) and mortality are approved as the core set domains. The main assessment tools for PRO include the AAV-specific PRO questionnaire (AAV-PRO), the Medical Outcomes Study Short-Form 36 (SF-36 v.2) and three generic Patient-Reported Outcomes Measurement Information System (PROMIS) instruments (fatigue, physical functioning, and pain interference). There are also a number of tools specific for the particular manifestations of the disease, such as glomerulonephritis, asthma or chronic rhinosinusitis.

Enhancing interventions of metastatic epidural spinal cord compression (MESCC) in elderly patients: prompt for further reflection.

This addresses the study by Lenga P. et al. on the surgical management of elderly patients with metastatic spinal cord compression (MSCC), acknowledging its valuable insights but suggesting areas for improvement. The absence of Patient-Reported Outcomes Measurement Information System (PROMIS) tools, arguing that patient-reported outcomes are crucial for evaluating the impact of interventions, the need for standardization in surgical approaches, the integration of a multidisciplinary team to optimize patient outcomes, non-surgical management strategies and stressing the importance of long-term follow-up is elaborated.

Elinzanetant for the Treatment of Vasomotor Symptoms Associated With Menopause

Safe and effective nonhormonal treatments for menopausal vasomotor symptoms (VMS) are needed. To evaluate the efficacy and safety of elinzanetant, a selective neurokinin-1,3 receptor antagonist, for the treatment of moderate to severe menopausal vasomotor symptoms. Two randomized double-blind phase 3 trials (OASIS 1 and 2) included postmenopausal participants aged 40 to 65 years experiencing moderate to severe vasomotor symptoms (OASIS 1: 77 sites in the US, Europe, and Israel from August 27, 2021, to November 27, 2023, and OASIS 2: 77 sites in the US, Canada, and Europe from October 29, 2021, to October 10, 2023). Once daily oral elinzanetant, 120 mg, for 26 weeks or matching placebo for 12 weeks followed by elinzanetant, 120 mg, for 14 weeks. Primary end points included mean change in frequency and severity of moderate to severe vasomotor symptoms from baseline to weeks 4 and 12, measured by the electronic hot flash daily diary. Secondary end points included Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b total T score and Menopause-Specific Quality of Life questionnaire total score from baseline to week 12. Eligible participants (mean [SD] age, OASIS 1: 54.6 [4.9] years; OASIS 2: 54.6 [4.8] years) were randomized to elinzanetant (OASIS 1: n = 199; OASIS 2: n = 200) or placebo (OASIS 1: n = 197; OASIS 2: n = 200). A total of 309 (78.0%) and 324 (81.0%) completed OASIS 1 and 2, respectively. For the elinzanetant and placebo groups, the baseline mean (SD) VMS per 24 hours were 13.4 (6.6) vs 14.3 (13.9) (OASIS 1) and 14.7 (11.1) v 16.2 (11.2) (OASIS 2). Baseline VMS severity was 2.6 (0.2) vs 2.5 (0.2) (OASIS 1) and 2.5 (0.2) vs 2.5 (0.2) (OASIS 2). Elinzanetant significantly reduced VMS frequency at week 4 (OASIS 1: -3.3 [95% CI, -4.5 to -2.1], P < .001; OASIS 2: -3.0 [95% CI, -4.4 to -1.7], P < .001) and at week 12 (OASIS 1: -3.2 [95% CI, -4.8 to -1.6], P < .001; OASIS 2: -3.2 [95% CI, -4.6 to -1.9], P < .001). Elinzanetant also improved VMS severity at week 4 (OASIS 1: -0.3 [95% CI, -0.4 to -0.2], P < .001; OASIS 2: -0.2 [95 CI, -0.3 to -0.1], P < .001) and week 12 (OASIS 1: -0.4 [95% CI, -0.5 to -0.3], P < .001; OASIS 2: -0.3 [95% CI, -0.4 to -0.1], P < .001). Elinzanetant improved sleep disturbances and menopause-related quality of life at week 12, and the safety profile was favorable. Elinzanetant was well tolerated and efficacious for moderate to severe menopausal VMS. ClinicalTrials.gov Identifier: OASIS 1: NCT05042362, OASIS 2: NCT05099159.

Current Use of Patient-Reported Outcome Measures Ignores Functional Demand.

Patient-reported outcome measures (PROMs) are used in orthopaedic surgery to measure aspects of musculoskeletal function that are important to patients, such as disability and pain. However, current assessments of function using PROMs do not necessarily consider a patient's functional demands in detail. A patient's functional demands could serve as a confounder to their perception of their functional ability. Hence, functional demands may need to be adjusted for when PROMs are used to measure musculoskeletal function. We conducted a cross-sectional study in which new orthopaedic patients completed a questionnaire regarding demographics, function [Patient-Reported Outcomes Measurement Information System], functional demand (Tegner Activity Level Scale), pain self-efficacy, and symptoms of depression. 169 eligible patients with diverse orthopaedic conditions were enrolled in the study from an orthopaedic clinic, and 19 were excluded for incomplete questionnaires. The mean Patient-Reported Outcomes Measurement Information System score was 36.5 ± 9.1, and the mean Tegner score was 2.6 ± 2.0. In the multivariable regression model, patient-reported function was significantly associated with functional demand (β = 0.17, P < 0.001). Significant associations were observed for pain self-efficacy (β = 0.15, P < 0.001), acuity (β = -0.10, P = 0.004), and age 80 years or older (β = -0.16, P = 0.004). No notable association was observed with depression or age 65 to 79 years. Higher patient-reported physical function is associated with higher levels of functional demand when controlling for psychosocial factors, acuity, and age. Because of its confounding effect on measuring physical function, functional demand should be assessed and included in models using PROMs before and after surgery. For example, payment models using improvements in PROMs, such as the short form of the Hip dysfunction and Osteoarthritis Outcome Score and the Knee injury and Osteoarthritis Outcome Score after joint arthroplasty, should include functional demand in the model when assessing quality of care. Level II.

Self-Compassion in Adolescents and Young Adults With Inflammatory Bowel Disease: Relationship of Self-Compassion to Psychosocial and Physical Outcomes.

Adolescents and young adults (AYAs) diagnosed with inflammatory bowel disease (IBD) are at an increased risk for poor physical and mental health due to the complexity of pediatric onset IBD and the unique developmental challenges of this period of life. Self-compassion is increasingly recognized as having an important role in explaining health outcomes and well-being across a range of populations. This study examines the relationship between self-compassion and psychosocial and physical health outcomes in AYAs with IBD. In this cross-sectional study, AYAs with IBD aged 15 to 25 years completed an online survey between February 2020 and October 2021. Questionnaires included the Self-Compassion Scale-Short Form, Patient-Reported Outcomes Measurement Information System (PROMIS) measures for psychosocial, physical and global health outcomes, and IBD disease activity indices. AYAs with higher levels of self-compassion were found to have better psychosocial (ie, anxiety, depressive symptoms, psychological stress, physical stress, peer relationships), physical (ie, fatigue), and global health outcomes. Self-compassion was a significant independent predictor of anxiety (β = -5.80, P = < .001), depressive symptoms (β = -7.09, P = < .001), psychological stress (β = -4.66, P = < .001), physical stress (β = -3.19, P = < .001), peer relationships (β = 3.39, P = .003), fatigue (β = -2.05, P = .019), and improved global health (β = 5.15, P = < .001). This study offers preliminary support for the importance of self-compassion in AYAs with IBD and demonstrates the need for further research in this area.

Comparable Real-World Patient-Reported Outcomes Data Across Health Conditions, Settings, and Countries: The PROMIS International Collaboration

The patient voice is critical to achieving value-based care, improving health outcomes, and advancing medical research. However, a key challenge is how to translate this “voice” into scientifically valid data that can inform evidence-based clinical decisions. One of the biggest barriers is the sheer variety of available patient-reported outcomes (PROs) and patient-reported outcome measures (PROMs) and the associated challenges of translation, validation, implementation, and interpretation, making it difficult to obtain valid and comparable health outcomes. The authors present a harmonized global approach to international standardization of PROs and PROMs. This approach has the potential to accelerate patient-centered care by facilitating the collection of accurate and comparable real-world evidence on health outcomes that matter most to patients. This proposed approach consists of two elements: a data collection process based on a common set of PROs and a state-of-the-art measurement approach based on item response theory. First, there is growing evidence that outcomes such as pain, fatigue, anxiety, depression, sleep disturbance, physical function, and the ability to participate in social roles and activities are relevant for most people, irrespective of their health condition. Measuring these outcomes routinely in all patients could increase outcome comparability and utility for a range of stakeholders. Second, a measurement strategy based on a state-of-the-art psychometric approach — using item response theory (IRT)-based item banks — offers short, flexible, sustainable, and universally applicable PROMs with robust measurement properties and a common measurement scale. The unique integration of these two elements offers the potential to collect comparable PROM data across patients and providers to support shared decision-making, which may lead to better outcomes. The Patient-Reported Outcomes Measurement Information System (PROMIS) is a globally used example of such an approach. The PROMIS Profile measures serve as a resource for measuring a harmonized core set of PROs across medical conditions, languages, and countries. To meet the United Nations Sustainable Development Goal of ensuring healthy lives and promoting well-being for all, at all ages, a collaborative effort is needed to achieve consensus on international standardization of PROs and PROMs to accelerate patient-centered care across health conditions, settings, and countries. The authors propose to routinely measure a core set of broadly relevant PROs in all patients, regardless of their health condition, with universally applicable IRT-based PROMs.

Greater Postoperative Biceps Tendon Migration Following Biceps Tenodesis Correlates with Lower Patient Reported Outcomes Scores

To assess the relationship between tendon migration, as measured by radiostereometric analysis (RSA), and patient-reported outcome measures (PROMs) following biceps tenodesis (BT); to determine the likelihood of achieving clinically significant outcomes (CSOs) following BT; and to identify factors that impact CSO achievement. Patients undergoing arthroscopic suprapectoral or open subpectoral BT at a single, high-volume academic medical center were prospectively enrolled. A tantalum bead sutured to the tenodesis construct was utilized as a radio-opaque marker. Biceps tendon migration was measured on calibrated radiographs at 12 weeks postoperatively. PROMs (Constant-Murley score [Constant], Single Assessment Numeric Evaluation [SANE], and Patient-Reported Outcomes Measurement Information Systemic-Upper Extremity [PROMIS-UE]) were collected preoperatively and at ≥2 years follow-up. Of 115 patients enrolled, 94 (82%) patients were included (median age=52 years and BMI=31.4 kg/m2). At a mean follow-up of 2.9 years, median Constant, SANE, and PROMIS-UE were 33 (interquartile range [IQR]=26-35), 90 (IQR=80-99), and 47 (IQR=42-58), respectively. Median tantalum bead migration was 6.5 mm (IQR 1.8-13.8). There was a significant correlation between migration and Constant (r2 = 0.222, beta= -0.554, 95% CI -1.027- [-0.081], P=0.022), SANE (r2 = 0.238, beta= -0.198, 95% CI -0.337 - [-0.058], P=0.006) and PROMIS-UE (r2 = 0.233, beta= -0.406, 95% CI -0.707 - [-0.104], P=0.009). In univariable analysis, higher BMI was associated with achievement of substantial clinical benefit (SCB, unadj-OR=1.078, 95%CI 1.007-1.161, P=0.038). Greater bead migration was negatively associated with achievement of minimal clinically important difference (MCID, unadj-OR=0.969, 95% CI 0.943-0.993, P=0.014) and patient acceptable symptomatic state (PASS, unadj-OR 0.965, 95% CI 0.937-0.989, P=0.008) on all 3 instruments. A 1 cm-increase in tenodesed biceps tendon migration was associated with a decrease in Constant, SANE, and PROMIS-UE of 6, 2, and 4 points, respectively, at a mean of 2.9 years after surgery. Most patients achieved clinically significant outcomes (CSOs) for these PROMs by latest follow-up, and greater biceps tendon construct migration was negatively associated with the likelihood of CSO achievement. IV, retrospective case series.

COMPARISON OF PROMIS SCORES AFTER TOTAL HIP AND TOTAL ANKLE ARTHROPLASTY: A PROPENSITY SCORE-MATCHED STUDY

This study evaluates patient reported outcome measurement information system (PROMIS) scores after total hip arthroplasty (THA) and total ankle arthroplasty (TAA) in matched cohorts, while simultaneously evaluating implant survivorship and 90-day hospital utilization. It is hypothesized that while both procedures would yield similar PROMIS score improvements, THA would demonstrate superior mid-term implant survivorship.Primary THA and TAA patients from 2015–2022 with minimum one-year follow-up were retrospectively reviewed. After applying exclusion criteria, 2,092 THAs and 478 TAAs were included for analysis. Demographics, pre- and post-operative patient reported outcome measures (PROMs), revision surgeries, ED visits, and re-admissions were collected. THA and TAA patients were then propensity score matched at 2:1 ratio for age, sex, race, BMI, ASA, and comorbidities, resulting in a final cohort of 844 THAs and 455 TAAs for comparison.There were similar pre-operative PROMIS Pain Interference (PI) scores between THA and TAA, with both showing improvement at six weeks. However, THA patients exhibited lower PI scores at one year (53.0 versus 54.0; p=0.009). Pre-operative PROMIS Physical Function (PF) was worse in THA patients but showed greater improvement compared to TAA patients at both six weeks (p&lt;0.001) and one year (p&lt;0.001). Pre-operative PROMIS depression scores were similar and improved similarly in both groups. Joint-specific PROMs (HOOS for THA and FAAM for TAA) improved in both cohorts. THA demonstrated superior survivorship free of all-cause revision at five years compared to TAA (95% versus 77%; p&lt;0.0001).Patients undergoing THA or TAA experienced significant improvements in their general and joint-specific PROMs post-operatively. However, patients undergoing THA demonstrated higher PROMIS PI and PF scores at one-year when compared to TAA, as well as improved survivorship. Generic PRO instruments enable comparison of medical treatments in different anatomic sites to the patients overall health.

Comparing patient-reported outcomes measurement information system® (PROMIS®)-16 domain scores with the PROMIS-29 and 5-item PROMIS cognitive function scores.

This study evaluates the interpretability of Patient-Reported Outcomes Measurement Information System® (PROMIS®)-16 profile domain scores (physical function, ability to participate in social roles and activities, anxiety, depression, sleep disturbance, pain interference, cognitive function - abilities, and fatigue) compared to the PROMIS-29 scores and a 5-item PROMIS cognitive function score. The study aims to provide insights into using these measures in clinical and research settings. Analyses were conducted using data from 4130 adults from a nationally representative, probability-based internet panel between September and October 2022. A subset of 1256 individuals with back pain was followed up at six months. We compared the PROMIS-16 profile with the corresponding domain scores from the PROMIS-29 and a custom five-item cognitive function measure. We evaluated (1) reliability through inter-item correlations within each domain and (2) criterion validity by comparing PROMIS-16 profile with the corresponding longer PROMIS measures: (a) standardized mean differences in domain scores, (b) correlations, and (c) concordance of change (i.e., got worse, stayed the same, got better) among those with back pain from baseline to six months later using the reliable change index. We report the Kappa coefficient of agreement and the frequency and percentage of participants with concordant classifications. Inter-item correlations for the PROMIS-16 domains ranged from 0.65 in cognitive function to 0.92 in pain interference. Standardized mean differences between PROMIS-16 and the scores for the corresponding longer PROMIS domains were minimal (< 0.2). Correlations among the corresponding domain scores ranged from 0.82 for sleep disturbance to 0.98 for pain interference. The percentage of concordance in change groups ranged from 63% for sleep disturbance to 88% for pain interference. Except for sleep disturbance, the change groups derived from the PROMIS-16 showed moderate to substantial agreement with scores estimated from the longer PROMIS measures (Kappa coefficients ≥ 0.41). The PROMIS-16 domain scores perform similarly to the longer PROMIS measures and can be interpreted in the same way. This similarity indicates that PROMIS-16 can be useful for research as a brief health-related quality-of-life profile measure.

Patient-Reported Preoperative Depression as a Predictor of Psychosocial Outcomes After Gender-Affirming Facial Feminization Surgery.

To understand psychosocial functioning before and after gender-affirming facial feminization surgery (FFS) as well as identify predictors of postoperative psychosocial functioning. Few investigations have rigorously explored the impact of gender-affirming FFS on psychosocial functioning in transgender and gender non-binary (TGNB) individuals. This knowledge gap hinders the identification of methods to optimize mental health quality-of-life outcomes after FFS and carries repercussions for access to care. Adult TGNB participants awaiting gender-affirming FFS were prospectively enrolled and administered Patient-Reported Outcomes Measurement Information System (PROMIS) instruments assessing anxiety, anger, depression, global mental and physical health, positive affect, emotional support, social isolation, companionship, and meaning and purpose before and 3-6 months after FFS. Paired t-tests compared pre- and postoperative scores. Multivariable linear models identified predictors of postoperative psychosocial outcomes. Among the domains, psychosocial scores improved for anxiety, depression, global mental health, social isolation, and positive affect after FFS. When accounting for potential variables contributing to postoperative psychosocial scores including other gender-affirming surgeries, hormone therapy duration, and private versus public insurance type, we found that preoperative depression scores independently predicted the variance in all other postoperative scores with global mental health (β=-0.52, 95%CI -0.58--0.31 P<0.001), anxiety (β=0.40, 95% CI 0.21-0.51, P<0.001), and meaning and purpose (β=-0.52, 95% CI -0.78--0.42 P<0.001) as the strongest models. This study suggests that gender-affirming FFS improves psychosocial functioning; however, such improvements are highly influenced by the baseline psychological functioning of each individual. These findings indicate that preoperative psychological functioning may be a potential avenue for improving outcomes after FFS via perioperative psychological interventions.

Mental Health Challenges in Cancer Patients: A Cross-Sectional Analysis of Depression and Anxiety.

Advancements in cancer treatment and early detection have extended survival rates, transforming many cancers into chronic conditions. However, cancer diagnosis and treatment can trigger significant psychological distress, including depression and anxiety, impacting patient outcomes and care. This study aimed to examine the prevalence of and identify the risk factors for depression and anxiety among cancer patients. A cross-sectional study was conducted, including patients under the care of the oncology department at a tertiary medical center between June 2021 and October 2023. Depression and anxiety were assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) short forms. Logistic regression analysis identified risk factors for depression and anxiety. The study population included 159 patients, with 40.3% reporting worsening mental health, but only about half of them received therapy. Among the study participants, 22.6% experienced symptoms of depression and 30.2% experienced symptoms of anxiety. Single-cancer patients and those with metastases were at increased risk for depression, while those with a disease duration of more than a year and patients with female-specific cancer were more likely to experience anxiety. Given the high prevalence of mental health deterioration in cancer patients, closer monitoring and validated assessment tools are essential to improve depression and anxiety diagnosis and facilitate early interventions.

Effects of Social Isolation and Loneliness on Heart Failure Self-care: A Cross-sectional Analysis.

Patients with heart failure (HF) who engage in effective HF self-care have better quality of life, and lower risks of all-cause and HF-related hospital readmission and mortality. It is unclear whether social isolation and loneliness, which are prevalent among patients with HF and known to affect other self-care behaviors, can predict HF self-care. The aim was to explore the relationship between social isolation, loneliness, and HF self-care. This was a cross-sectional secondary analysis (n = 49) of the GEtting iNTo Light Exercise for HF randomized controlled trial, a 6-month home-based live group gentle exercise intervention for patients with HF. Measures included the following: 6-item Lubben Social Network Scale for social isolation, Patient-Reported Outcomes Measurement Information System Social Isolation survey for loneliness, Self-Care of Heart Failure Index, and Patient-Reported Outcomes Measurement Information System Depression survey. Multiple linear regression modeling was used to examine the relationships of 4 HF self-care processes to social isolation and loneliness, adjusting for depression and grouping (control group or intervention group). Scores indicating less social isolation predicted higher self-care maintenance (B = 0.937, P = .015), monitoring (B = 0.799, P = .041), and management (B = 1.812, P < .001). Loneliness did not predict HF self-care. To our knowledge, this is the first study to predict HF self-care using distinct measures for social isolation and loneliness. Patients who were less socially isolated engaged in better HF self-care; loneliness had no relationship with HF self-care. Prospective studies are needed to investigate causal relationships between social isolation and HF-self-care engagement to determine the effect on outcomes such as hospital readmission and mortality.

Agreement between child self-report and parent-proxy report for functioning in pediatric chronic pain

PurposeAccurate assessment of chronic pain and functional disability in children and adolescents is imperative for guiding pain management interventions. Parents have multifaceted roles in their child’s pain experience and frequently provide parent-proxy reports of pain-related functioning. However, cross-informant variance is often observed with limited understanding of contributing factors. This study aims to examine the degree of alignment between child and parent-proxy reports for Patient-Reported Outcomes Measurement Information System (PROMIS) pain interference domain among children with chronic pain and to identify factors associated with improved child-parent agreement.MethodsThis study includes a sample of 127 youth (66.1% female) with mixed etiology chronic pain, ranging in age from 8 to 17 (M = 12.24; SD = 1.598), and their parent. Data was collected at an interdisciplinary pediatric pain clinic and online peer support groups. Measures of demographic, pain intensity, and functioning were collected.ResultsMeans of parent-proxy reports were significantly lower than child self-reports on the PROMIS (p < 0.05). A statistically significant association between child’s pain intensity (β = 0.953, P < 0.05) and the difference between child self-reported and parent-proxy reported PROMIS functional interference scores was found.ConclusionParents underestimated pain-related functional disability relative to children’s self-reports. The difference between the paired child self-report and parent-proxy report of functional disability was significantly associated with greater child self-reported pain intensity. Although parent-proxy reports in pediatric chronic pain is often used in research and practice, findings underscore the importance of incorporating child and adolescent self-report, when possible, to comprehensively capture the child’s pain experience and best inform clinical interventions.

Predictors of health-related quality of life (HRQoL) for caregivers of children with developmental disabilities in Saudi Arabia: An observational study.

To examine predictors of health-related quality of life (HRQoL) for caregivers of children with developmental disabilities, a cross-sectional design was used. Participants were primary caregivers of children with developmental disabilities. Caregivers completed a demographic form about the child and the family, and the Arabic version of Patient-Reported Outcomes Measurement Information System-Profile 29 (PROMIS-29 v2.0). Descriptive statistics were used to report on demographic data, 1-sample Z tests to compare PROMIS domain scores with the general population, and multiple linear regression analyses to identify predictors of each domain. Participants were 111 primary caregivers, mostly mothers (65.8%). Caregivers reported higher levels of anxiety, depression, fatigue, sleep disturbance, and pain interference, and lower levels of physical function and social participation compared to the general population, P < .05. The regression models for predicting the HRQoL accounted for 12.3% of the variance in the physical function domain (P = .016), 13.9% in the anxiety domain (P = .009), 24.7% in the ability to engage in social activities and roles (P < .001), and 11.4% in the pain interference domain (P = .02). In these models, the severity of the child's disability and/or the child's age were common significant predictors. Specifically, child's age was the only significant predictor in 2 domains, the anxiety domain (β = -.29, P < .01) and ability to participate in social activities and roles domain (β = .42, P < .05). The severity of the child's disability was the only significant predictor in the physical function domain (β = -.52, P < .01). Both the severity of the child's disability and the child's age were significant predictors in the pain interference model (β = .40, P < .05), and (β = -.23, P < .05), respectively. However, the models did not significantly predict depression, fatigue, or sleep disturbance, P > .05. HRQoL is a complex construct and is influenced by multiple child and family factors. Implications of the study emphasize the importance of regular HRQoL screening for caregivers, the development of efficient referral systems for support services, and the exploration of respite care options.

Patient-reported outcomes and daily activity assessed with a digital wearable device in patients with paroxysmal nocturnal hemoglobinuria treated with ravulizumab: REVEAL, a prospective, observational study

BackgroundParoxysmal nocturnal hemoglobinuria (PNH) is a rare, chronic blood disorder. Symptoms such as fatigue can have a substantial impact on patients’ physical activity levels, sleep, quality of life, and work productivity. Ravulizumab treatment can reduce thrombosis risk, improve survival and quality of life, and reduce fatigue in PNH, but information is limited on how it impacts sleep and physical activity. Here, data on resting heart rate, daily physical activity, and sleep in ravulizumab-treated patients with PNH were passively collected via a digital wearable activity-tracking device and patient-reported outcome (PRO) data were collected via weekly surveys in the same cohort.MethodsREVEAL was a 32-week prospective observational cohort study in individuals with PNH receiving ravulizumab in the USA. A wrist-worn Fitbit™ collected data on resting heart rate, daily step count, and sleep duration from eligible patients. Patients also completed the following electronic weekly surveys: Functional Assessment of Chronic Illness Therapy (FACIT) – Fatigue, Patient-Reported Outcomes Measurement Information System (PROMIS) Global Physical Health, PROMIS Global Mental Health, PROMIS Sleep-Related Impairment and Sleep Disturbance, and Work Productivity and Activity Impairment Questionnaire – Specific Health Problem (WPAI-SHP). Data collected from the activity trackers and surveys were compared against US general population values reported in the literature.ResultsTwenty-eight ravulizumab-treated patients were included (median age: 34 years; 54% female). PRO scores were within US general population normative values, including FACIT-Fatigue (40.0), PROMIS Global Physical Health (51.0), Global Mental Health (51.0), Sleep-Related Impairment (50.0), and Sleep Disturbance (49.0). Similarly, mean resting heart rate (67 bpm), daily step count (7476), and sleep duration (7.7 h) were within the range of US general population values. Daily step count was positively correlated with PROMIS Global Physical and Mental Health scores.ConclusionsThis was the first study to use digital monitoring technology to collect data on physical activity and sleep in patients with PNH. The findings indicate that ravulizumab treatment enables patients with PNH to achieve activity levels (heart rate, sleep duration, step count) and quality of life that are comparable to those of the US general population. A weak positive correlation was identified between patient-reported physical and mental health and daily physical activity levels.

The Impact of Preoperative Intra-articular Injections on Postoperative Outcomes in Hip Arthroscopy

Introduction: Hip arthroscopy is a minimally invasive procedure commonly performed to treat various hip conditions. Preoperative intra-articular injections, such as local anesthetics and corticosteroids, are frequently used to alleviate pain and as a diagnostic tool before hip arthroscopy. However, studies have shown conflicting information; some demonstrate better patient outcomes, while others have found an increased risk of complications and negative effects on postoperative recovery. This retrospective study evaluated the association between preoperative injections and postoperative outcomes in hip arthroscopy patients. Materials and Methods: A retrospective review of 1400 patients who underwent hip arthroscopy between 2014 and 2021 at our institution was performed. The patients were allocated into two cohorts based on whether they received a cortisone injection with local anesthetic within 1 year before the surgery. Outcomes during the study follow-up period (average: 437 days, max: 3018 days) were compared. Further analysis looked at subgroups at 30-day increments. Results: The results showed that 35.5% of the patients had received a preoperative injection. Although patients who received injections were more likely to be female (68.3% injected vs. 60.8% not injected, P = 0.019) and have asthma (12.5% injected vs. 7.3% not injected, P = 0.008), there were no significant differences in 90-day complications, 90-day emergency department visits, 90-day readmissions, any complications (wound infection, re-injury, recurrent pain or weakness, deep vein thrombosis, or pulmonary embolism), prolonged pain or recovery, reoperation, total hip arthroplasty, 6-month Patient-Reported Outcomes Measurement Information System Physical Function, 6-month Hip Dysfunction and Osteoarthritis Outcome Score Joint Replacement, or follow-up time between the injection and noninjection groups. There were no other differences in demographics, comorbidities, or physical function between the groups. Conclusion: Our study suggests that preoperative corticosteroid injections with local anesthetics do not significantly affect postoperative outcomes in hip arthroscopy patients or increase the risk of adverse effects. Careful evaluation of these risks and benefits is crucial to minimize potential adverse effects and maximize patient outcomes.

Trauma Prevalence and Its Association With Health-Related Quality of Life in Pregnant Persons with Opioid Use Disorder.

Trauma screening is recommended for pregnant persons with opioid use disorder (OUD), but there is limited literature on screening results from buprenorphine treatment. This study's objectives were to 1) describe the types, and severity, of traumatic events reported and 2) evaluate the associations between trauma and health-related quality of life (HRQoL). Baseline data from an ongoing trial were analyzed. Participants were 155 pregnant persons with OUD receiving, or enrolling in, buprenorphine treatment at one of 13 sites. The experience, and relative severity, of 14 high magnitude stressors were assessed with the trauma history screen. The Patient-Reported Outcomes Measurement Information System-29+2 was used to assess 8 HRQoL domains. Traumatic stressors were reported by 91% of the sample (n = 155), with 54.8% reporting a lifetime persisting posttraumatic distress (PPD) event and 29.7% reporting a childhood PPD event. The most prevalent lifetime PPD event was sudden death of a close family/friend (25.8%); physical abuse was the most prevalent childhood PPD event (10.3%). Participants with lifetime PPD, relative to no PPD, reported significantly greater pain interference (P = 0.02). Participants with childhood PPD, relative to no PPD, had significantly worse HRQoL overall (P = 0.01), and worse pain intensity (P = 0.002), anxiety (P = 0.003), depression (P = 0.007), fatigue (P = 0.002), and pain interference (P < 0.001). A majority of pregnant persons enrolled/enrolling in buprenorphine treatment reported persisting posttraumatic distress with sudden death of close family/friend being the most prevalent originating event; clinicians should consider the impact that the opioid-overdose epidemic may be having in increasing trauma exposure in patients with OUD.

Age-Related Hearing Loss, Cognitive Decline, and Social Interaction: Testing a Framework.

Aging increases risk for hearing loss, cognitive decline, and social isolation; however, the nature of their interconnection remains unclear. This study examined the interplay between age-related hearing loss, cognitive decline, and social isolation in adults by testing the ability to understand speech in background noise, a challenge frequently reported by many older adults. We analyzed data collected from 128 adults (20-79 years of age, Mage = 51 years) recruited as part of the Aging Brain Cohort at the University of South Carolina repository. The participants underwent testing for hearing, cognition, and social interaction, which included pure-tone audiometry, a words-in-noise (WIN) test, a hearing questionnaire (Speech, Spatial and Qualities of Hearing Scale [SSQ12]), a social questionnaire (Patient-Reported Outcomes Measurement Information System-57 Social), and the Montreal Cognitive Assessment. We used a single pure-tone average (PTA) threshold value and a single WIN threshold value for each participant because there were no differences on average between the left and right ears. Poorer hearing was significantly associated with cognitive decline, through both PTA and WIN thresholds, with a stronger association observed for WIN threshold. Adults with poorer hearing also exhibited greater social isolation, as evidenced by their WIN threshold and SSQ12 score, although not through PTA. This connection was more pronounced with the WIN threshold than with the SSQ12 score. Cognition was not related to social isolation, suggesting that social isolation is affected more by the ability to understand words in noise than by cognition in a nondemented population. Understanding speech in challenging auditory environments rather than mere threshold detection is strongly linked to social isolation and cognitive decline. Thus, inclusion of a word-recognition-in-noise test and a social isolation survey in clinical settings is warranted. https://doi.org/10.23641/asha.26237060.

Social isolation, depression, and anxiety among young adult cancer survivors: The mediating role of social connectedness.

Social isolation and social connectedness are health determinants and aspects of social well-being with strong associations with psychological distress. This study evaluated relationships among social isolation, social connectedness, and psychological distress (i.e., depression, anxiety) over 1 year in young adult (YA) cancer survivors 18-39 years old. Participants were YAs in a large cohort study that completed questionnaires every 2 months for 1 year. Social isolation, aspects of social connectedness (i.e., companionship, emotional support, instrumental support, and informational support), depression, and anxiety were assessed with Patient-Reported Outcomes Measurement Information System short form measures. Mixed-effect models were used to evaluate changes over time. Confirmatory factor analysis and multilevel structural equation modeling were used to define social connectedness as a latent construct and determine whether relationships between social isolation and psychological distress were mediated by social connectedness. Participants (N = 304) were mean (M)= 33.5 years old (SD = 4.7) and M = 4.5 years (SD = 3.5) post-initial cancer diagnosis. Most participants were female (67.4%) and non-Hispanic White (68.4%). Average scores for social well-being and psychological distress were within normative ranges and did not change (p values >.05). However, large proportions of participants reported at least mild social isolation (27%-30%), depressive symptoms (36%-37%), and symptoms of anxiety (49%-51%) at each time point. Across participants, more social isolation was related to less social connectedness (p values <.001), more depressive symptoms (p < .001), and more symptoms of anxiety (p < .001). Social connectedness mediated the relationship between social isolation and depression (p = .004), but not anxiety (p > .05). Social isolation and connectedness could be intervention targets for reducing depression among YA cancer survivors.

Point of Care Ultrasound Guided Management of Lateral Ankle Sprains: A Case Series.

Lateral ankle sprain (LAS) is a common injury with incidence rates reported at 7.2 per 1000 person-years. Physical examination strategies provide limited information to guide rehabilitation that can maximize clinical outcomes. Early and accurate diagnostic information using ultrasound imaging enables individualized care and the ability to monitor healing along with its response to activity and rehabilitation. The purpose of this study was to describe and observe the outcomes associated with Point of Care Ultrasound (POCUS) guided early management of acute and sub-acute lateral ankle sprains. Case series. Individuals with a LAS within the prior 28 days underwent a clinical evaluation to include a POCUS exam to assess ligamentous integrity. Objective and POCUS findings were integrated to classify each LAS into one of four categories. Each grade of ankle sprain corresponded to levels of bracing for the protection of injured structures with each patient receiving physical therapy care based on rehabilitation guidelines. Participants completed the Foot and Ankle Ability Measure (FAAM) activities of daily living and Sports subscale, the Foot and Ankle Outcome Score (FAOS), Patient Reported Outcomes Measurement Information Systems Global Health, Tampa Scale of Kinesiophobia (TSK-11), Cumberland Ankle Instability Tool (CAIT), and the Numeric Pain Rating Scale as well as the Ankle Lunge Test and Figure 8 measurements at baseline, 4 weeks, 8 weeks and 12 weeks post enrollment. The FAAM Sport subscale, all FAOS subscales, and the TSK-11 were also collected at 24 weeks while the CAIT was collected at baseline and 24 weeks. Fourteen participants were enrolled with 11 participants completing all data collection. FAAM Sport scores significantly improved at 4, 8, 12 and 24 weeks. All components of the FAOS significantly increased except for Sport scores at four weeks and Quality of Life scores at four and eight weeks. POCUS guided early management and ligamentous protection of LASs resulted in significant short and long-term improvement in function and return to sporting activity. This case series highlights the feasibility of using ultrasound imaging to assess the severity of ligamentous injury and align bracing strategies for ligamentous protection. The observations from this case series suggest that functional bracing strategies focused on ligamentous protection to promote healing and reduce re-injury rates does not delay improvement in functional outcomes. Level IV, Case Series.