Patient-reported Outcomes In Patients Research Articles

Development and Measurement Properties of the Danish Translation of the Groin Hernia-Q: Protocol for a Validation Study

Background: The patient reported outcome questionnaire Abdominal Hernia-Q is probably the most thoroughly validated patient-reported outcome measure specifically developed for patients undergoing ventral hernia repair. The present study aims to adapt and validate the Danish translation of the Abdominal Hernia-Q for patients undergoing groin hernia repair: the Groin Hernia-Q. Methods: This validation study will involve a total of 250 participants and it is divided into two substudies. Substudy 1 will focus on adapting the Abdominal Hernia-Q into the Groin Hernia-Q and assessing its content validity using the QQ-10 questionnaire. Substudy 2 will evaluate the structural validity, internal consistency, test-retest reliability, measurement error and construct validity of the Groin Hernia-Q, while also utilizing and comparing the results to the Carolinas Comfort Scale and Short-Form 12. Participants will be recruited both in a clinical setting and electronically. Data collection will be conducted through the platform Research Electronic Data Capture (REDCap). In addition to questionnaire data, this study will also involve perioperative and patient-related data extracted from the Danish National Patient Registry and the Danish Hernia Database. This study is part of the AFTERHERNIA Project. Conclusion: This study will provide a comprehensive validation of the Groin Hernia-Q, ensuring it becomes a valuable tool for assessing patient-reported outcomes in patients undergoing groin hernia repair. The questionnaire will contribute significantly to improved patient care through the AFTERHERNIA Project.

Patient-reported outcomes in patients with relapsed or refractory follicular lymphoma treated with zanubrutinib plus obinutuzumab versus obinutuzumab monotherapy: results from the ROSEWOOD trial

Objective We report patient-reported outcomes (PROs) measuring health-related quality of life (HRQoL) from the ROSEWOOD trial (NCT03332017), which demonstrated superior efficacy and a manageable safety profile with zanubrutinib plus obinutuzumab (ZO) versus obinutuzumab (O) in patients with heavily pretreated relapsed/refractory follicular lymphoma (R/R FL). Methods PROs were assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire – Core 30 (EORTC QLQ-C30) and EQ-5D-5L questionnaires at baseline and subsequently every 12 weeks. All QLQ-C30 domains and EQ-5D-5L visual analog scale (VAS) scores were analyzed descriptively. At the key clinical timepoints (weeks 12 and 24), a mixed model for repeated measures (MMRM) analysis was used to evaluate the key PRO endpoints, including global health status, physical and role functioning, and symptoms of fatigue, pain, diarrhea, and nausea/vomiting. Clinically meaningful change was defined as a ≥ 5-point mean difference from baseline and between the ZO and O arms. Results Patients were randomized to ZO (n = 145) or O (n = 72). By week 48, descriptive analysis results indicated that patients in the ZO arm demonstrated improved outcomes in role functioning and fatigue and nausea/vomiting symptoms, compared with those in the O arm. Both groups experienced improvements in pain symptoms. EQ-5D-5L VAS scores showed no observable differences between treatment arms through week 48. MMRM analysis revealed that the global health status/quality of life of patients treated with ZO improved, as did fatigue, at week 12. At week 24, patients in the ZO arm experienced a clinically meaningful improvement in role functioning, pain, and fatigue. Conclusions In patients with R/R FL, ZO was associated with improved PROs compared with O. These findings suggest that zanubrutinib contributed clinically meaningful benefits to patient HRQoL when added to obinutuzumab. Trial registration The ROSEWOOD trial is registered on ClinicalTrials.gov (BGB-3111-212; ClinicalTrials.gov identifier: NCT03332017).

Ventral Hernia Repair With a Hybrid Absorbable-permanent Preperitoneal Mesh.

To analyze device safety and clinical outcomes of ventral hernia repair with the GORE SYNECOR Preperitoneal Biomaterial (PRE device), a permanent high-strength mesh with bioabsorbable web scaffold technology. This multicenter retrospective review analyzed device/procedure endpoints and patient-reported outcomes in patients treated for hernia repair ≥1 year from study enrollment. Included in this analysis were 148 patients with a mean age of 56 years; 66.2% met the Ventral Hernia Working Group grade 2 classification. Median hernia size was 30.0cm 2 and 58.8% of patients had an incisional hernia. Repairs were primarily a robotic (53.4%) or open approach (41.9%). All meshes were placed extraperitoneal. Procedure-related adverse events within 30 days occurred in 13 (8.8%) patients and included 7 (4.8%) patients with surgical site infection, 2 (1.4%) with surgical site occurrence (SSO), 4 (2.7%) requiring readmission, and 3 (2.0%) who had reoperation. The rate of SSO events requiring procedural intervention was 2.7% (4 patients) through 30 days and 3.4% (5 patients) at 12 months. The rate of procedure-related surgical site infection remained at 4.8% through 12 months (no further reports after 30d) and 3.4% for SSO (2 reports after 30d). There were no site-reported clinically diagnosed hernia recurrences throughout the study. Median patient follow-up including in-person visit, physical examination, reported adverse event, explant, death, and questionnaire response was 28 months (n = 148). Median patient follow-up with patient questionnaire was 36 months (n = 88). Use of the PRE device, which incorporates the proven advantages of both an absorbable synthetic mesh and the long-term durability of a permanent macroporous mesh, is safe and effective in complex ventral hernia repairs. When used in the retromuscular space, the combination of these 2 materials had lower wound complications and recurrence rates than either type of material alone.

8008 Insulin-like Growth Factor-1 (IGF-1) Level Fluctuations and Patient Reported Outcomes (PROMS) During Treatment with Long-acting Somatostatin Receptor Ligands (SRLs) for Acromegaly: a Prospective Study

Abstract Disclosure: I. Remba-Shapiro: None. J.R. Schweizer: None. K.J. Liebert: Consulting Fee; Self; Crinetics, Recordati Rare Diseases, Novo Nordisk. K. Schilbach: None. M. Adams: Consulting Fee; Self; Chiesi. N.A. Tritos: None. M. Bidlingmaier: Consulting Fee; Self; Ipsen, Ionis Pharmaceuticals Inc., Novartis Pharmaceuticals, Novo Nordisk, Pfizer, Inc., Roche Pharmaceuticals. L.B. Nachtigall: Consulting Fee; Self; Crinetics. Grant Recipient; Self; Amryt, Recordati Rare Diseases. Background: SRLs are the most used medical therapy for acromegaly. Some patients report symptoms of acromegaly towards the end of the injection cycle even when IGF-1 levels are controlled. IGF-1 fluctuations within an injection cycle have been observed. In this study we investigated the variability of biochemical markers and PROMS in patients receiving long-acting SRLs. Methods: Subjects with acromegaly controlled with monthly lanreotide depot or octreotide LAR were recruited. Blood samples at 1 and 4 weeks after SLR injection were collected in 2 consecutive cycles. Clinical characteristics were evaluated. Quality of life (QoL) surveys included: Acromegaly Quality of Life Questionnaire (AcroQoL) (higher scores = better QoL) and Patient Assessed Acromegaly Symptom Questionnaire (PASQ) (higher scores = worse QoL). Week 1 vs. week 4 values were compared. Quest Diagnostics LC-MS assay was used to measure IGF-1. Coefficient of variation (CV = (IGF-1 SD)/(IGF-1 mean)%) of IGF-1 was calculated. Values ≤5% were interpreted as being a consequence of assay variability. Variables are presented as mean (SD) and compared using t-test; p <0.05 was considered significant. Results: Patients (6 women, 4 men) had a mean age of 56.1 (15.4) years. Eight underwent TSS. One had diabetes mellitus, 3 had hypertension. Mean IGF-1 index (IGF-1 x upper limit of normal) at screening was 0.63 (0.23). BMI was 27.7 (5.8) kg/m2. IGF-1 index at week 1 was 0.57 [0.16] vs. 0.61 [0.23] at week 4, p=0.271. Insulin levels were lower in week 1 vs. week 4 (7.3 [4.4] vs. 9.7 [6.0]mIU/mL p=0.041). There were no significant differences in GH, glucose, weight, blood pressure and ring size in week 1 vs. week 4. PASQ varied significantly within the injection cycle with higher scores in week 4 (18.1 [10.8]) compared to week 2 (16.1 [10.4] p=0.032) and week 3 (14.2 [8.8] p= 0.002). ACROQoL scores did not differ by injection phase. IGF-1 increased more than assay CV from week 1 to week 4 in 8/20 (40%) determinations. An ROC curve identified an IGF-1 index cutoff of 0.57 at week 4 (AUC: 0.812, p=0.021) as a predictor of IGF-1 index increase within the injection cycle (CV > 5%): sensitivity 88%, specificity 75%. Five patients had IGF-1 index > 0.57 at week 4 during both cycles (range 0.60-1.2). In this group, mean IGF-1 index was higher at week 4 vs. week 1 (0.77 [0.21] vs. 0.66 [0.14] p=0.026). The 5 patients with IGF-1 index < 0.57 at week 4 had no difference in IGF-1 index between week 4 and week 1 (0.48 [0.14] vs. 0.44 [0.09] p=0.144). Conclusions: This prospective study of patients with acromegaly controlled with long-acting SRLs demonstrates injection phase variability in self-reported symptoms by PASQ. An IGF-1 index > 0.57 at the end of the cycle may warrant injection phase-dependent monitoring. Larger studies to confirm the IGF-1 cutoff above which patients should be monitored in a cycle-dependent manner will allow an individualized approach to optimize management. Presentation: 6/2/2024

The association of diabetes mellitus and routinely collected patient-reported outcomes in patients with cancer. A real-world cohort study.

Current studies have indicated that diabetes mellitus (DM) is highly prevalent in patients with cancer, but there is little research on consequences on the well-being of patients during cancer treatment. This analysis evaluates the relationship between DM and patient-reported outcomes (PRO) in patients with cancer, using a large and well-characterized cohort. This study utilized the Total Cancer Care protocol at the University of Utah Huntsman Cancer Institute. For this analysis, we integrated data from electronic health records, the Huntsman Cancer Registry, and routinely collected PRO questionnaires. We assessed the association between DM in patients with cancer and PRO scores for anxiety, depression, fatigue, pain interference, and physical function using multiple linear regression and t-tests. The final cohort comprised 3512 patients with cancer, with a mean age of 57.8 years at cancer diagnosis. Of all patients, 49.1% (n = 1724) were female, with 82.0% (n = 2879) patients reporting PROs at least at one time point. Compared with patients who responded, nonresponders were more often female (p = 0.0035), less frequently non-Hispanic White (p = 0.0058), and had a higher BMI (p = 0.0759). Patients with cancer and diabetes had worse PRO scores for anxiety (p = 0.0003), depression (p < 0.0001), fatigue (p < 0.0001), pain interference (p < 0.0001), and physical function (p < 0.0001) compared to patients with cancer without diabetes. Significant associations between diabetes and PRO scores were observed for anxiety (β ± SE: 1.27 ± 0.48; p = 0.0076), depression (β ± SE: 1.46 ± 0.45; p = 0.0011), fatigue (β ± SE: 2.11 ± 0.52; p < 0.0001), pain interference (β ± SE: 1.42 ± 0.50; p = 0.0046), and physical function (β ± SE: -2.74 ± 0.48; p < 0.0001). The results of this study suggest that patients with cancer and diabetes may be at greater risk for anxiety, depression, fatigue, higher pain interference, and reduced physical function. Strengthening diabetes management is imperative to address the negative impact of diabetes on PROs. In particular, this may be true for patients with skin, breast, prostate, and kidney cancer.

Recovery in patients undergoing ablative fractional carbon dioxide laser for adult hypertrophic burn scars: a longitudinal cohort study

IntroductionAblative fractional carbon dioxide laser (AFCO2L) is widely used as a treatment for hypertrophic burn scars. This study aimed to evaluate clinician and patient-reported outcomes after AFCO2L treatment, safety, and identify factors influencing outcomes. MethodsThis longitudinal study recruited adult patients with hypertrophic burn scars treated with AFCO2L at a single Australian burn unit. Patients received up to four AFCO2L treatments over approximately 12 months. Outcomes were ultrasound scar thickness, the Patient and Observer Scar Assessment Scale (POSAS), and the Brisbane Burn Scar Impact Scale (BBSIP), measured at baseline and 3, 6, and 12-months post first AFCO2L treatment. Analysis used mixed effects linear models. Results47 patients were included with median age 32 years (IQR:24,53) and median burn TBSA of 35% (IQR:7.5%,48%). Statistically significant improvements between baseline and 12-month follow-up occurred in scar thickness, all POSAS and BBSIP subscores. Most improvements remained when accounting for TBSA, Fitzpatrick skin type, scar maturity, and body area treated. Patients reported transient symptoms after 61 of 89 (69%) AFCO2L treatments, but infection or delayed wound healing occurred after only 4 of 89 (4%) treatments. ConclusionThis study supports safety and improved clinician and patient-reported outcomes in patients undergoing AFCO2L for hypertrophic burn scars.

Mid-term patient-reported outcomes are inferior in opening-wedge high tibial osteotomy patients with untreated medial meniscus posterior root tear.

The impact of untreated medial meniscus posterior root (MMPR) tear (MMPRT) during opening-wedge high tibial osteotomy (OWHTO) on patient-reported outcomes (PROs) remains poorly understood. This retrospective cohort study aimed to investigate the association between the presence of MMPRT and post-operative PROs in patients who underwent OWHTO. A total of 83 knees that underwent OWHTO that were followed up for 6.6 years were included. Post-operative PROs were assessed using the knee injury and osteoarthritis outcome score (KOOS) subscales. Medial meniscus extrusion (MME) was measured by magnetic resonance imaging (MRI). MMPRT was diagnosed based on preoperative MRI and intraoperative arthroscopy findings. The participants were categorized into the MMPRT and MMPR intact (MMPRI) groups, and their KOOS subscales were compared. Additionally, logistic regression analysis was conducted to explore the correlation between KOOS and MMPRT presence. In total, 29 out of 80 (36.3%) knees were classified into the MMPRT group, while three knees underwent total knee arthroplasty. Preoperative MME was 3.5 ± 1.9 (range 0-8.9) mm, showing correlation with the presence of MMPRT (p = 0.004) by regression analysis. The post-operative KOOS subscales of the MMPRT group were lower than the MMPRI group for pain (p = 0.017), activities of daily living (ADLs) (p = 0.001), sports (p < 0.001) and quality of life (QOL) (p < 0.001). Additionally, regression analysis showed the presence of MMPRT was correlated with lower KOOS subscale scores for pain (p = 0.041), ADLs (p = 0.011), sports (p < 0.001) and QOL (p = 0.002). Preoperative MMPRT correlated with a reduction in mid-term post-operative PROs, as assessed using the KOOS, among patients who underwent OWHTO. Surgeons should consider addressing an MMPRT at the time of OWHTO. Level IV.

The relationship between patient-reported experience and patient-reported outcomes in patients with cancer.

248 Background: Measures of patient experience (PEX) and patient-reported outcomes (PRO) are used by health systems across the US to improve care delivery and quality of life, respectively. Despite their widespread use, little is known regarding the relationship between these two types of patient-generated data. From 2018 to 2023, we conducted a pragmatic type-II hybrid effectiveness/implementation study of an electronic health record (EHR)-embedded symptom management program (eSyM) across six diverse cancer centers. This project focused on patients who started chemotherapy (CHEMO) or had surgery (SURG) for a suspected or confirmed gastrointestinal, gynecologic, or thoracic malignancy. Methods: We conducted a cross-sectional study of adults who were eligible for either the control or intervention arm of the eSyM study to determine if patients who reported having an inferior care-team experience were more likely to report having worse symptoms. Participants completed a one-time survey via REDCap that included elements from the Consumer Assessment of Healthcare Providers and Systems (CAHPS) and the Patient-Reported Outcomes Measurement Information System (PROMIS). Analyses determined the extent to which PEX measures were associated with PRO measures by evaluating differences in mean PROMIS scores for those who rated their PEX highly vs. not highly. Results: In total, 1419 respondents reported having cancer for which they received care at a participating center: median age 66, 63% female, 5% black, 13% disabled, 66% married/partnered, 23% high school or less education, 22% somewhat-extreme difficulty paying bills. For both CHEMO and SURG patients, 82% rated their overall cancer care-team experience highly (top box score of 9-10). Compared to patients who did not rate their care-team experience highly, those who did reported better scores for depression, fatigue, anxiety, pain interference, physical function, and self-efficacy (Table). PROMIS values differed for other CAHPS measures too. Conclusions: Among patients receiving routine cancer care, there was a significant association between PEX and multiple PROs. Further investigation of the nature and strength of the association between PEX and PRO measures is warranted. If confirmed, this association could lead to the development of interventions that impact both patient satisfaction and quality of life. Clinical trial information: NCT03850912 . Mean difference in PROMIS scores for patients who rated their care-team experience highly versus not highly (P from two-sample T-test). CHEMO (N=889) SURG (N=530) Mean Diff 95%CI P value Mean Diff 95%CI P value Depression -2.7 -4.3, -1.1 0.001 -3.3 -5.3, -1.4 &lt;0.001 Anxiety -3.7 -5.4, -1.9 &lt;0.001 -3.6 -5.7, -1.5 &lt;0.001 Fatigue -2.3 -4.0, -0.5 0.011 -4.5 -6.8, -2.2 &lt;0.001 Pain interference -3.6 -5.3, -1.9 &lt;0.001 -4.7 -6.7, -2.7 &lt;0.001 Physical function 1.6 0.1, 3.1 0.042 3.5 1.4, 5.6 0.001 Self-efficacy 3.9 2.6, 5.2 &lt;0.001 6.4 4.6, 8.1 &lt;0.001

Patient-reported outcomes in patients with metastatic non-squamous non-small cell lung cancer from the randomized Phase II PERLA trial comparing first-line chemotherapy plus dostarlimab or pembrolizumab

BackgroundPERLA (NCT04581824) compared efficacy and safety of dostarlimab (DCT) or pembrolizumab (PCT) plus chemotherapy as first-line treatment for metastatic non-small cell lung cancer. Here, we report patient-reported outcomes (PROs; exploratory analysis) from PERLA. MethodsPatients were randomized 1:1 to receive DCT or PCT every 3 weeks (Q3W) for ≤ 35 cycles [C]. PROs (EORTC QLQ-C30 and QLQ-LC13, PRO-CTCAE, FACT-GP5) were collected at baseline, Q3W until C4, Q9W until C16, Q12W until end of treatment and at 30-day safety follow-up. Change from baseline and time to deterioration (TTD) in QLQ-C30 and QLQ-LC13 were analyzed using longitudinal mixed models and Kaplan–Meier estimators, respectively. ResultsThe PRO (DCT/PCT) datasets included 102/99 patients for QLQ-C30, 96/90 for QLQ-LC13, 96/88 for PRO-CTCAE, and 95/87 for FACT-GP5. Completion rates were > 80 % to C4, then decreased in both arms. For QLQ-C30 and QLQ-LC13, most patients reported stable/improved responses at C13 (∼ 9 months on treatment), with similar responses between arms except more patients reported improvements in dyspnea (QLQ-C30: 36.4 % vs 13.0 %; QLQ-LC13: 40.6 % vs 25.0 %) and chest pain (QLQ-LC13: 34.4 % vs 10.0 %) with DCT vs PCT. TTD per QLQ-C30 and QLQ-LC13 were similar between arms, although TTD in dyspnea was longer with DCT vs PCT (QLQ-LC13: 4.24 vs 1.54 months; p = 0.0168). Most patients in both arms reported that adverse events occurred occasionally/rarely/never with moderate/mild severity. Overall, patients reported little/no bother from treatment side effects. ConclusionsDCT maintained health-related quality of life similarly to PCT and was well tolerated, supporting the PERLA primary results and dostarlimab use in future regimens.

Guselkumab in Biologic-Naïve Patients with Active Psoriatic Arthritis in Russia: A Post Hoc Analysis of the DISCOVER-1 and -2 Randomized Clinical Trials.

There are limited data on the use of advanced therapies to treat psoriatic arthritis (PsA) in Russia. Guselkumab, an interleukin (IL)-23p19-subunit inhibitor, demonstrated efficacy in patients with PsA in the phase3 DISCOVER-1 and -2, and COSMOS trials. This analysis evaluated the efficacy and safety of guselkumab in patients with PsA in Russia. This posthoc analysis of DISCOVER-1 and -2 included 1002 biologic-naïve patients with active PsA from Russia (n = 317) and the rest of the world (RoW; n = 685). Patients received guselkumab 100mg every 4weeks (Q4W), or at week0 and 4 then Q8W, or placebo then guselkumab Q4W at week24 (Russian: n = 119, 88, and 110, respectively; RoW: n = 216, 246, and 223, respectively). Outcomes through week52 were pooled (DISCOVER-1 and -2); outcomes from week52 to 100 represent DISCOVER-2 only. In patients from Russia, ≥ 20% improvement in the American College of Rheumatology (ACR20) criteria response rates were higher with guselkumab vs. placebo at week24, increased through week52, and were consistent across all guselkumab-treated groups at week100. Similar trends were generally observed for ACR50, ≥ 90% improvement in Psoriasis Area and Severity Index (PASI90), achievement of Disease Activity in Psoriatic Arthritis (DAPSA) low disease activity/remission and minimal disease activity, enthesitis and dactylitis resolution, ≥ 0.35 improvement in Health Assessment Questionnaire-Disability Index (HAQ-DI) score, improvement in patient-reported pain, and measures in patients with axial PsA (including Bath Ankylosing Spondylitis Disease Activity Index [BASDAI], Ankylosing Spondylitis Disease Activity Score [ASDAS], and patient-reported spinal pain). Efficacy responses were similar between patients from Russia and the RoW across all endpoints and timepoints. The safety profile of guselkumab in patients from Russia was consistent with previous findings. This analysis demonstrated that the safety and efficacy profiles of guselkumab across all PsA domains and patient-reported outcomes in patients from Russia were similar to those in patients from the RoW. NCT03162796 and NCT03158285.

Efficacy and Feasibility of Intradialytic Plantar Electrical Stimulation in Patients With Diabetes: A Randomized Double-Blind Controlled Trial.

This study investigates the efficacy and feasibility of electrical stimulation (E-Stim) on sensory fibers of the plantar region during hemodialysis sessions, aiming to improve mobility in patients with diabetes by providing a connection between E-Stim and enhanced mobility with minimal patient effort required. Participants age ≥18 years with diabetes undergoing hemodialysis and able to walk at least 10 m with or without aid were recruited and divided into an intervention group receiving 1-h intradialytic E-Stim three times a week and a control group using an identical nonfunctional device for 12 weeks. Gait, physical activity, patient-reported outcomes, and the technology acceptance model were assessed to evaluate the intervention's effectiveness and acceptance. Out of 117 initial participants, 97 completed the study. Significant improvements were observed in the intervention group compared with the control group in gait performance (stride time at dual-task and fast walking), physical activity (stand to walk and sit to stand), quality of life, plantar numbness, and cognitive function after 12 weeks. The intervention group showed that magnitudes of improvement on gait performance and physical activity metrics were associated with enhancements in quality of life and cognitive function, respectively. The intervention group also reported higher usefulness and usage satisfaction, with a greater willingness to continue using E-Stim at home. The 12-week intradialytic E-Stim intervention is a feasible and effective method to enhance gait performance, physical activity level, cognitive function, and other patient-reported outcomes in patients undergoing hemodialysis, representing a practical, low-risk therapy option for those unable to engage in traditional exercise programs.

MHealth Physical Activity and Patient-Reported Outcomes in Patients With Inflammatory Bowel Diseases: Cluster Analysis.

Regular physical activity is associated with improved quality of life in patients with inflammatory bowel diseases (IBDs), although much of the existing research is based on self-reported data. Wearable devices provide objective data on many rich physical activity dimensions including steps, duration, distance, and intensity. Little is known about how patients with IBDs engage in these varying dimensions of exercise and how it may influence their symptom and disease-specific patient-reported outcomes (PROs). This study aims to (1) cluster physical activity patterns from consumer-grade wearable devices and (2) assess the relationship between the clusters and PROs in patients with IBDs. We conducted a cross-sectional and longitudinal cohort study among adults with IBDs in the Crohn's and Colitis Foundation IBD Partners cohort. Participants contribute physical activity data through smartphone apps or wearable devices in a bring-your-own-device model. Participants also complete biannual PRO questionnaires from the Patient-Reported Outcomes Measurement Information System short forms and IBD-specific questionnaires. K-means cluster analysis was used to generate physical activity clusters based on 3 key features: number of steps, duration of moderate to vigorous activity (minutes), and distance of activity (miles). Based on the clusters, we conducted a cross-sectional analysis to examine differences in mean questionnaire scores and participant characteristics using one-way ANOVA and chi-square tests. We also conducted a longitudinal analysis to examine individual cluster transitions among participants who completed multiple questionnaires, and mean differences in questionnaire scores were compared using 2-tailed paired sample t tests across 6-month periods. Among 430 participants comprising 1255 six-week physical activity periods, we identified clusters of low (33.7%, n=423), moderate (46%, n=577), and high (20.3%, n=255) physical activity. Scores varied across clusters for depression (P=.004), pain interference (P<.001), fatigue (P<.001), sleep disturbance (P<.001), social satisfaction (P<.001), and short Crohn Disease Activity Index (P<.001), with those in the low activity cluster having the worst scores. Sociodemographic characteristics also differed, and those with low physical activity were older (P=.002), had higher BMIs (P<.001), and had longer disease durations (P=.02) compared to other clusters. Among 246 participants who completed at least 2 consecutive questionnaires consisting of 726 questionnaire periods, 67.8% (n=492) remained in the same cluster, and only 1.2% (n=9) moved to or from the furthest clusters of low and high activity across 6-month periods. For patients with IBDs, there were positive associations between physical activity and PROs related to disease activity and psychosocial domains. Physical activity patterns mostly did not fluctuate over time, suggesting little variation in exercise levels in the absence of an intervention. The use of real-world data to identify subgroups with similar lifestyle behaviors could be leveraged to develop targeted interventions that provide support for psychosocial symptoms and physical activity for personalized IBD care.

A Real-World Analysis of Weather Variation on Disease Activity and Patient-Reported Outcomes in Psoriatic Arthritis.

Patients with inflammatory articular diseases, such as psoriatic arthritis (PsA), report weather changes in their symptoms. Our objective was to investigate the correlation between weather variation, disease activity (DA), and patient-reported outcomes (PROs) in patients with PsA. Hourly measurements of temperature, relative humidity, and pressure were obtained from 2015 to 2020 in Montreal (through Environment Canada) and were matched with DA and PROs of patients with PsA enrolled in Rhumadata. The differences in mean DA and PROs were examined between winter and summer. Pearson correlation coefficients were calculated between clinical profile and weather measurements. Among patients with PsA, 2665 PROs were collected for a total of 858 patients. The Clinical Disease Activity Index (P = 0.001) and Simplified Disease Activity Index (P < 0.001) were lower in winter. In summer, positive correlations were found between humidity and symptoms (using patient global assessment, fatigue, pain, C-reactive protein, Bath Ankylosing Spondylitis Disease Activity Index, Bath Ankylosing Spondylitis Functional Index), whereas negative correlations between temperature and Health Assessment Questionnaire-Disability Index were reported. In winter, positive correlations were observed between temperature, fatigue, and pain. This is the first study to investigate weather variations through subjective and objective PROs matched with patients with PsA. Statistically significant differences in clinical profile were evident between winter and summer, as well as in their correlation with weather measurements. However, these distinctions lack clinical significance, suggesting a small impact on patients with PsA.

A Comparison of the Convenience, Quality of Interaction, and Satisfaction of Virtual and In-Person Healthcare Consultations: A Nationwide Study.

Background: There are few direct comparisons of service utilization and patient-reported outcomes in patients attending medical consultations in person or virtually. This was a prospective, cross-sectional study of adults engaging with a healthcare practitioner via virtual or in-person consultations. Methods: Participants were recruited in person by convenience sampling between November 2023 and January 2024 across Saudi Arabia, and data were gathered on (i) basic demographic and consultation information and (ii) convenience, quality of interaction, and satisfaction with their consultations. Results: Of 3196 individuals who completed the survey, 28.7% had attended their most recent healthcare interaction virtually and 71.3% had attended in person. Participants attending virtual consultations were more likely to live rurally (69.0% vs. 21.9% for in-person consultations; p < 0.001). Virtual appointments were more common for primary care and diabetes/endocrinology but not surgical specialties (p < 0.001), and private apps and hospitals more frequently provided virtual appointments. Conclusions: Overall, patients found virtual consultations to be significantly more convenient, prompt, private, and well communicated than in-person appointments, translating into extremely high satisfaction (97.4% overall vs. 84.0% for in-person consultations; p < 0.001). This study provides population-level data on the current prevalence of telehealth use in Saudi Arabia. Further prospective research demonstrating the clinical noninferiority of telemedicine could help promote further uptake in specialties such as surgery.

53081 Dupilumab Treatment Provides Sustained Improvement in Skin Barrier Function, Clinical Outcomes, and Patient-Reported Outcomes in Patients Aged 6 to 11 Years With Moderate-to-Severe Atopic Dermatitis

53081 Dupilumab Treatment Provides Sustained Improvement in Skin Barrier Function, Clinical Outcomes, and Patient-Reported Outcomes in Patients Aged 6 to 11 Years With Moderate-to-Severe Atopic Dermatitis

MPN-085 Association Between Hemoglobin Improvement and Patient-Reported Outcomes in Patients With Myelofibrosis and Anemia: Post Hoc Pooled Analysis of Momelotinib Phase 3 Trials

MPN-085 Association Between Hemoglobin Improvement and Patient-Reported Outcomes in Patients With Myelofibrosis and Anemia: Post Hoc Pooled Analysis of Momelotinib Phase 3 Trials

Phrenic neuropathy etiologies and recovery trajectories in outpatient rehabilitation and neuromuscular medicine clinics: A retrospective analysis.

Phrenic neuropathy (PhN) impairs diaphragm muscle function, causing a spectrum of breathing disability. PhN etiologies and their natural history are ill-defined. This knowledge gap hinders informed prognosis and management decisions. This study aims to help fill this knowledge gap on PhN etiologies, outcomes, and recovery patterns, especially in the context of nonsurgical clinical practice. This was a retrospective study from two interdisciplinary clinics, physiatry and neurology based. Patients were included if PhN was identified, and other causes of hemi-diaphragm muscle dysfunction excluded. Patients were followed serially at the discretion of the neuromuscular-trained neurologist or physiatrist. Recovery was assessed using pulmonary function tests (PFTs), diaphragm muscle ultrasound (US) thickening ratio, and patient-reported outcomes in patients presenting within 2 years of PhN onset. We identified 151 patients with PhN. The most common etiologies were idiopathic (27%), associated with cardiothoracic procedure (24%), and intensive care unit (17%). Of these patients, 117 (77%) were evaluated within 2 years of PhN onset. Of patients included in outcome analyses, 64% saw improvement on serial US, 50% on serial PFTs and 79% reported symptomatic improvement at an average of 15, 16, and 17 months, respectively. A clear majority of PhN patients show improvement in diaphragm muscle function, but on average, improvements took 15-17 months depending on the assessment type. These insights are vital for developing tailored treatments and can guide physicians in prognosis and decision-making, especially if more invasive interventions are being considered.

Association Between Hemoglobin Improvement and Patient-Reported Outcomes in Patients With Myelofibrosis and Anemia: Post Hoc Pooled Analysis of Momelotinib Phase 3 Trials

Association Between Hemoglobin Improvement and Patient-Reported Outcomes in Patients With Myelofibrosis and Anemia: Post Hoc Pooled Analysis of Momelotinib Phase 3 Trials

Association between personality type and patient-reported outcomes (PRO) in patients with atrial fibrillation

BackgroundAtrial Fibrillation (AF) is known to be associated with a negative emotional state. Patient-reported outcomes (PROs) are important tools for evaluating the endpoints of AF management. This study aims to examine the correlation between personality types and PROs in patients with AF.MethodsAll included subjects were newly diagnosed with AF fewer than one month, and their personality types were assessed using the Eysenck Personality Questionnaire (EPQ). Quality of life (QoL) was measured using the Atrial Fibrillation Effect on Quality of Life (AFEQT) questionnaire. Anxiety and depression were assessed using the General Anxiety Scale (GAD-7) and the 9-item Patient Health Questionnaire (PHQ-9), respectively. We constructed stepwise linear regression analyses for factors related to the QoL and emotional state in patients with AF.ResultsA total of 531 AF patients completed the survey and were categorized into four groups based on their personality types. Of these patients (mean age: 67.12 ± 10.93 years, 50.28% male), 357 (67.23%) had paroxysmal AF, and 16.95% (n = 90) had a sanguine personality. Compared to patients with other personality types, those with a sanguine personality had the highest average AFEQT scores (P < 0.001) and the lowest scores of GAD-7 and PHQ-9 scales (P < 0.05). Furthermore, multiple linear regression analyses suggested that sanguine personality was also independently associated with better QoL and emotional states (P < 0.05).ConclusionThere is a significant association between the personality types and PROs in AF patients.

Comparison of clinical and patient-reported outcomes in patients with benign euthyroid solitary nodules after ultrasound-guided percutaneous microwave ablation and endoscopic thyroidectomy.

Percutaneous ultrasound-guided microwave ablation (MWA) for benign solid thyroid nodules is the newest modality for treatment. However, the differences in treatment outcomes between MWA and endoscopic thyroidectomy vestibular approach (TOETVA) for patients with benign euthyroid solitary nodules remain unknown. We are sharing initial results from our prospective study. Prospective study between January 2022 and December 2023 was conducted and data were noted at 3 time points in patients planned for treatment (Preoperative, 1week, and 12months). Main outcome measures were clinical outcome and comparison of thyroid-related quality of life using the ThyPRO-39hin and swallowing-related quality of life using the SWAL-QoL. Of the 36 included patients, 20 patients underwent TOETVA and 16 underwent MWA. Both the groups were comparable in terms of demographic and clinicopathological profiles. The nodule volume reduction rate of patients at 12months after MWA was 75.10% and 100% for TOETVA. The mean preoperative ThyPRO-39hin and SWAL-QoL scores were comparable in all domains between the two groups. Mean ThyPRO-39hin and SWAL-QoL scores on postoperative day 7 were significantly better in the MWA group in domains impaired social life (p<0.0001) and impaired daily life (p=0.0002). However, at the end of 12months, mean ThyPRO-39hin and SWAL-QoL scores became significantly better in the TOETVA group as compared to the MWA group. Our findings suggest that transoral endoscopic thyroidectomy results in significant superior clinical outcome, thyroid-related quality of life, and swallowing-related quality of life in the long term.