Patient-reported Outcome Surveys Research Articles

Effects of a Virtual Trauma Clinic on admissions and length of stay for minor to moderate trauma.

To investigate the feasibility of a Virtual Trauma Clinic (VTC) for patients with minor to moderate trauma, and evaluate patient satisfaction and outcomes. One hundred VTC patients were matched 1:1 with historical patients from the hospital trauma registry who received conventional care. Matching was based on age ± 5 years, sex, mechanism of injury, Injury Severity Score ± 2, trauma team activation and day of week of presentation. VTC patients were sent surveys on experience and outcome measures. VTC was associated with reduced average hospital length of stay for admitted patients by 1.81 days (95% CI = -2.82, -0.79; P = 0.001) and reduced hospital admissions (odds ratio 0.26; 95% CI = 0.14, 0.48; P < 0.001). There was an avoidance of 199 inpatient bed days in total, with no trauma-related readmissions within 30 days post-hospital discharge. 92% of respondents (n = 22) rated the care they received from VTC as excellent or good. Patient-reported outcome surveys showed overall improvement in functional domains but evidence of ongoing disability, with persistent issues of pain and psychological distress at 1 month post-injury. Patients with minor to moderate trauma have ongoing care needs with high rates of pain, psychological distress and disability remaining prevalent long after discharge. VTC provided an innovative strategy for hospital avoidance with high levels of patient satisfaction and no adverse effects on safety. The overall quality of care for these patients was enhanced through the provision of standardised, patient-centred and multidisciplinary follow-up.

Decision regret and long-term success rates after ventral buccal mucosa graft urethroplasty.

To characterise the long-term success rate of ventral onlay buccal mucosa graft urethroplasty (vBMG) in the management of bulbar urethral stricture disease (USD), assess patient-reported postoperative satisfaction and decision regret, and delineate clinical factors impacting patient-reported metrics. Patients with prior vBMG for bulbar USD, performed at Cleveland Clinic between 2003 and 2022, were contacted and brief structured interviews were performed. Stricture recurrence and need for secondary procedures, baseline demographics, and patient-reported outcome surveys were collected. The surveys included the Decision Regret Scale (DRS), the Urethral Stricture Symptom Impact Measure (USSIM) and the 10-item Patient-Reported Outcomes Measurement Information System Short Form, version 1.2 (PROMIS-10). Descriptive, univariate and multivariable analyses were performed for clinical outcomes and survey responses. A total of 104 patients recorded responses. The median patient age was 49 years and the median follow-up was 7.4 years at time of survey. The median graft length was 5 cm and 38% of patients underwent partial thickness augmented anastomotic urethroplasty. At time of follow-up, 10 patients underwent a secondary procedure. Moderate to severe regret on the DRS was found in 12% of patients, and greater regret was associated with recurrence. The mean physical and mental health PROMIS-10 Global Health T-scores were 52 and 53. The mean total USSIM score was 56. A significant correlation was found between USSIM and DRS scores, with higher DRS score and recurrence negatively impacting USSIM score. USSIM scoring across all domains was significantly worse in the moderate to severe DRS group. This study showed that vBMG for bulbar USD confers both high success rates and patient-reported satisfaction at extended follow-up, based on emerging and validated patient-reported outcome measures.

Improving the assessment and documentation of systemic cancer therapy–related toxicity in the ambulatory oncology setting.

221 Background: Accurate documentation of systemic cancer therapy toxicity is crucial for patient safety and effective treatment management. However, achieving consistent and comprehensive documentation remains challenging. While the use of electronic patient-reported outcomes (ePROs) is becoming standard in clinical practice, small community-based practices lack the resources to implement this strategy. This project aims to offer alternative methods for implementing patient-reported outcomes in such practices and utilize this information to enhance the documentation of systemic cancer therapy toxicities using the CTCAE (Common Terminology Criteria for Adverse Events). Methods: We conducted a quality improvement project targeting the adequate assessment and documentation of graded toxicity assessments among healthcare providers. Interventions included implementing a patient-reported outcome survey created using the National Cancer Institute PRO-CTCAE form builder, which patients completed while waiting to be seen by the provider. Additionally, we educated providers on how to use the CTCAE grading tool available in Cerner. Rates of documented graded toxicity assessment using the CTCAE system were evaluated among 71 patients aged 18 years or older receiving systemic cancer therapy and attending follow-up appointments at the Seton Cancer Clinic. Data were collected from electronic medical records both before and after the intervention, with 50 patients assessed pre-intervention and 21 patients assessed post-intervention. Results: The implementation of the patient-reported outcome survey and the utilization of the CTCAE grading tool available in Cerner facilitated a more consistent and comprehensive assessment and documentation process. Post-intervention, the rate of documented graded toxicities increased significantly; the percentage of patients with documented graded toxicities increased from 4% pre-intervention to 80% post-intervention. The intervention also improved the workflow efficiency and the accuracy of toxicity assessments in the oncology clinic. Conclusions: These findings highlight the importance of implementing strategies to improve the assessment and documentation of systemic cancer therapy-related toxicity, especially in small community-based practices where resources may be limited. Continued monitoring and periodic data collection will be essential for sustaining these improvements.

Influence of Diet on Bowel Function and Abdominal Symptoms in Children and Adolescents with Hirschsprung Disease-A Multinational Patient-Reported Outcome Survey.

Introduction: This study aimed to understand the influence of diet and nutrition items on gastrointestinal symptoms in patients with Hirschsprung Disease (HD). Method: An online questionnaire was created to obtain patient-reported outcomes using the multinational Holistic Care in Hirschsprung Disease Network. This was distributed in Dutch, English, German, Italian, Polish, and Swedish via patient associations. Information on demographics, the extension of disease, current diet, and the influence of food ingredients on bowel function were obtained. Results: In total, 563 questionnaires were answered by parents or patients themselves. The length of the aganglionic segment was short in 33%, long in 45%, total colonic aganglionosis (TCA) in 11%, and involved the small intestine in 10%. Overall, 90% reported following a mixed diet, and 31% reported taking probiotics, with twice as many patients taking probiotics in the TCA group compared to standard HD. Mealtimes and behaviours around eating were affected by 61%, while 77% had established food items that worsened symptoms, and of these, 80% stated that they had worked these items out themselves. A high-fibre diet was followed by 24% and 18% a low-fibre diet. Symptoms were reported, particularly from dairy in 30%, fruits in 39%, pulses in 54%, and sugar in 48%. Conclusions: This first multinational survey on diet and bowel function in HD reports an association between certain dietary items with gastrointestinal symptoms. This study can support an improved understanding of the interaction between food items and bowel function in children with HD. We suggest a multidisciplinary approach to balance dietary exclusions and support adequate growth, preventing nutrition deficiencies and enhancing quality of life.

Chronic kidney disease–associated pruritus: a comparison of instruments and associations with patient-reported outcomes using an electronic patient-reported outcome survey in Europe

ABSTRACT Background The associations between self-reported chronic kidney disease–associated pruritus (CKD-aP) and patient-reported outcomes (PROs) have been reported using various instruments to assess itch. Data collection via multiple CKD-aP instruments allows the evaluation of different domains and measurements of CKD-aP burden and may help tailor data capture for future research or clinical care. Methods An electronic PRO (ePRO) survey was distributed to European hemodialysis (HD) patients enrolled in the Dialysis Outcomes and Practice Patterns Study (DOPPS) in 2021–23. The DOPPS is an international cohort study that aims to investigate practice patterns and outcomes in HD patients. The ePRO survey included multiple CKD-aP instruments: Average Itch and Worst Itching Intensity Numerical Rating Scales (AI-NRS, WI-NRS) and a Kidney Disease Quality of Life (KDQOL)-36 single question. Linear and logistic regression were used to estimate adjusted associations between CKD-aP instruments and various PROs. Results This analysis included 769 patients who completed the WI-NRS from HD facilities in France, Germany, Italy, Spain, Sweden and the UK. The correlation between WI-NRS and the KDQOL-36 itch question was 0.88 overall and 0.46 among patients at least somewhat bothered by itch. Mean WI-NRS scores stratified by response to the KDQOL-36 itch question were 8.1, 6.4, 4.1 and 3.1 for extremely, very much, moderately and somewhat bothered, respectively. Patients with worse WI-NRS scores reported worse sleep quality, greater fatigue, more depressive symptoms, and lower mental and physical quality of life; these associations were similar to those observed for the KDQOL-36 itch question. Conclusion Correlation between CKD-aP instruments was high overall, but moderate among the subgroup of patients bothered by itch; differences can be partially attributed to the recall period for the KDQOL-36 (4 weeks) vs the AI- and WI-NRS (24 h). The consistent associations of these instruments with poor outcomes underscores the importance to identify and effectively treat HD patients suffering from pruritus.

Doxycycline Sclerotherapy of Aneurysmal and Unicameral Bone Cysts in the Appendicular Skeleton and Pelvis: Single-Center 14-Year Experience

PurposeTo evaluate the safety, effectiveness, and patient satisfaction of doxycycline sclerotherapy for aneurysmal bone cysts (ABCs) and unicameral bone cysts (UBCs). Materials and MethodsThis was an institutional review board (IRB)–approved single-center retrospective review of all ABCs and UBCs of the appendicular skeleton and pelvis completing doxycycline sclerotherapy and having at least 2 years of follow-up from 2007 to 2021. Radiographic outcomes in a patient cohort were assessed with a modified Neer score. Patient-reported outcome (PRO) surveys were completed by a subgroup of the cohort assessing pain after treatment (Likert scale), functional outcomes (Patient-Reported Outcomes Measurement Information System), and overall patient satisfaction (adapted from the Musculoskeletal Tumor Society). ResultsSeventy-seven lesions met the inclusion criteria, with 55 (71%) receiving bone void filler in addition to doxycycline. Of the 77 lesions, 76 (99%) were successfully treated. Twelve lesions (16%) recurred but resolved with additional doxycycline treatment. One lesion failed sclerotherapy, requiring surgical excision. Of the 383 total treatments performed, 17 resulted in Society of Interventional Radiology (SIR)–classified adverse events (9 with Grade 1, 7 with Grade 2, and 1 with Grade 3). Twenty-five (32%) of the 77 cases completed PRO surveys, with 20 (80%) having little to no pain and 15 (60%) having no functional impairment after completing treatment. The PRO surveys documented high levels of satisfaction, with all patients agreeing that they would undergo doxycycline sclerotherapy again if given the option. ConclusionsDoxycycline sclerotherapy (with or without bone void filler) is a safe, effective, and well-tolerated stand-alone treatment for ABCs and UBCs.

Patient-Reported Outcomes Improve with a Virtual Diabetes Care Model that Includes Continuous Glucose Monitoring.

Background: The objective was to examine patient-reported outcomes (PROs) associated with access to a virtual clinic model for diabetes care. Methods: Adults with diabetes (N = 234) received virtual care, including support for continuous glucose monitoring (CGM) over a 6-month study period. Care was led by a Certified Diabetes Care and Education Specialist and focused on optimizing self-management skills and response to glucose values observed on CGM. After 6 months of CGM use and access to diabetes education, participants could opt in to another 6 months of follow-up with access to the virtual care team. Participants completed PRO surveys and had health and glycemic measures collected at baseline, 3, 6, and 12 months. Results: Participants with type 1 diabetes (N = 160) were 44 ± 14 years and had mean baseline HbA1c of 61 mmol/mol (7.7%). Participants with type 2 diabetes (N = 74) were 52 ± 12 years and had mean baseline HbA1c of 66 mmol/mol (8.2%). Compared with baseline levels, at 6 months participants experienced less depression, diabetes distress, and hypoglycemic fears while also experiencing greater satisfaction with glucose monitoring, diabetes technology and specifically with CGM, and confidence for managing hypoglycemic (p < 0.05). For participants with type 1 diabetes, more time in the target range for glucose levels (70-180 mg/dL) was associated with less depression, diabetes distress, and hypoglycemic fears. Conclusions: PROs improved for adults with diabetes utilizing virtual diabetes care, including support for CGM use. Paired with the glycemic improvements observed in this virtual clinic study, there were robust benefits on the quality of life of adults with diabetes. ClinicalTrials.gov Identifier: NCT04765358.

Functional and Symptomatic Improvements Based on the Femoral Tunnel Drilling Technique in Anterior Cruciate Ligament (ACL) Reconstruction.

The current literature comparing femoral tunnel techniques often reports on short-term outcomes after anterior cruciate ligament reconstruction (ACLR), but only a few studies have analyzed long-term outcomes. In addition, many studies have compared transtibial to anteromedial portal techniques without differentiating whether rigid or flexible reaming is used, making it difficult to infer how the techniques truly compare to one another. This study aimed to detect differences in patient-reported outcome scores in those treated with three different femoral tunnel drilling techniques. This study is a prospective cohort study. Of 650 patients treated for anterior cruciate ligament (ACL) injuries with ACLR, 350 were 5+ years out from surgery. Of these patients, 111 completed patient-reported outcome surveys (PROs). The Kruskal-Wallis H test was used to detect differences between patients treated with either of the three femoral tunnel drilling techniques: transtibial (TT), anteromedial portal with rigid reaming (AMP-RR), or anteromedial portal with flexible reaming (AMP-FR). Bonferroni correction was applied to the p-values to reduce the risk of making a type 1 error. No differences were found between the three groups in demographics or postoperative PROs. However, there was a significant change between pre-surgery and post-surgery PROs. TT, when compared to AMP-RR, had a greater increase in satisfaction and greater improvement in a patient's ability to go up and down the stairs from pre-surgery to post-surgery. AMP-FR, when compared to TT, had greater improvement of the patient's knee stiffness/swelling. AMP-FR, when compared to AMP-RR, had greater improvement in knee pain during stairs and the ability to go down the stairs. No differences in return to sport, additional procedures on the affected knee (meniscal surgeries or cyclops lesion excisions), or revision surgery rates were found. Overall, postoperative PROs did not show statistically significant differences between the three femoral tunnel drilling techniques. Differences, however, were identified in the responses to specific questions on PRO surveys, which may have otherwise been overlooked. It is important to recognize the differences between TT, AMP-RR, and AMP-FR in the improvement of stair climbing and swelling/stiffness as these likely directly affect a patient's satisfaction from pre-ACLR to post-ACLR.

Patient Reported Outcome Measures in Adults with Fontan Circulatory Failure.

Background: Patient reported outcomes (PROs) are important measures in acquired heart disease but have not been well defined in Adult Congenital Heart Disease (ACHD). Our aim was to explore the discriminatory capacity of PRO survey tools in Fontan circulatory failure (FCF). Methods: Consecutive adults were enrolled from our ambulatory clinics. Inclusion criteria were age ≥18 years, a Fontan circulation or a hemodynamically insignificant shunt lesion, and sufficient cognitive/language abilities to complete PROs. A comprehensive package of PRO measures, designed to assess perceived health-related quality of life (HRQOL) was administered (including the Kansas City Cardiomyopathy Questionnaire [KCCQ-12], EuroQol-5-dimension [EQ5D], Short Form Health Status Survey [SF-12], self-reported New York Heart Association [NYHA] Functional Class, and Specific Activity Scale [SAS]). Results: We compared 54 Fontan patients (35 ± 10 years) to 25 simple shunt lesion patients (34 ± 11 years). The KCCQ-12 score was lower in Fontan versus shunt lesion patients (87 [IQR 79, 95] versus 100 [IQR 97, 100], p-value < 0.001). The FCF subgroup was associated with lower KCCQ-12 scores as compared with the non-FCF subgroup (82 [IQR 56, 89] versus 93 [IQR 81, 98], p-value = 0.002). Although the KCCQ-12 had the best discriminatory capacity for determination of FCF of all PRO tools studied (c-statistic 0.75 [CI 0.62, 0.88]), superior FCF discrimination was achieved when the KCCQ-12 was combined with all PRO tools (c-statistic 0.82 [CI 0.71, 0.93]). Conclusions: The KCCQ-12 questionnaire demonstrated good discriminatory capacity for the identification of FCF, which was further improved through the addition of complementary PRO tools. Further research will establish the value of PRO tools to guide management strategies in ACHD.

Androgen deprivation therapy in advanced prostate cancer: insights from a real-world patient survey on health-related quality of life and information and communication sources.

Androgen deprivation therapy (ADT) is a cornerstone treatment for advanced and metastatic prostate cancer. Real-world and patient-reported insights into ADT's impact on health-related quality of life (HRQoL) and communication experiences in healthcare settings remain underexplored. This patient organisation-initiated online survey aimed to assess these aspects. Between December 2022 and August 2023, the patient organisation Think Blue Vlaanderen and the AZ Sint-Jan Hospital (Bruges, Belgium) invited ADT-treated patients to participate in a prospective, online, cross-sectional, patient-reported outcome survey. Demographic, clinical, HRQoL (FACT and EPIC-26), communication sources and information modality data were collected. Descriptive statistics and comparative analyses were applied. A total of 276/312 (88.5%) participating patients were on ADT at time of survey administration and completion, with the majority receiving a 3-monthly regimen. Sexual HRQoL was low and narrowly distributed (median (IQR): 16.7 (16.7-16.7)), with 84% of patients having erectile dysfunction (ED). Patients finding their ED problematic were more likely to seek pharmaceutical treatment. Hormonal HRQoL was widely distributed (median (IQR): 65 (45-85)), which improved with prolonged ADT duration. Physically active patients reported less lack of energy, but increased hot flashes. Within consistent FACT-G summary scores (median (IQR): 64.50 (54.75-77.00)), improved emotional wellbeing with prolonged ADT was noted. Multidisciplinary communication and multimodal information provision improved patient satisfaction. Patient organisation-initiated surveys offer real-world and patient-reported insights. Patient-tailored HRQoL assessments and longitudinal follow-up, physical activity, and multidisciplinary and multimodal communication approaches are warranted to improve patient-centred care in patients receiving ADT.

The pre-operative window of endocrine therapy to inform radiation therapy decisions (POWER) trial: Baseline patient beliefs about breast cancer and endocrine therapy.

11115 Background: The POWER Trial (NCT04272801) aims to determine whether pre-operative endocrine therapy (pre-ET) impacts physician recommendations and patient preferences for adjuvant radiation (RT) and endocrine therapy (AET) among women who qualify for RT omission. While physicians characterize this population as low-risk, they often still recommend RT. The POWER trial captures baseline patient perspectives regarding recurrence and medication tolerance using patient-reported outcome surveys and examines how these influence treatment choices. Methods: POWER Trial participants received 90 days of pre-ET before surgery and treatment decisions regarding RT. Women ≥ 65 years old with ER+ tumors ≤ 2 cm, node negative were eligible. Patient beliefs about their cancer and medications were assessed at baseline using the Beliefs About Illness Questionnaire (BIP-Q), Beliefs About Medicine Questionnaire-ET (BMQ-ET), and Perceived Sensitivity to Medicines (PSM) scale. An additional novel, non-validated questionnaire was created to further evaluate patients’ beliefs. Results: The study cohort included 48 women with mean age of 73.7. Few patients (14.6%) viewed their breast cancer as having a high threat to their health. While half (50.0%) of the participants worried a lot about the return of their breast cancer, only 35.4% thought that a cancer recurrence would be devastating. Participants who worried more about their breast cancer returning were more likely to feel a recurrence would be devastating (Pearson Correlation Coefficient = .67). There was no association between baseline beliefs and RT omission. Most patients (81.3%) did not consider themselves sensitive to medications. Although 81.3% reported side effects as important when deciding to continue or stop medications, almost all participants (95.8%) stated they would continue medications, despite side effects, if it would help lower their risk of recurrence. When specifically asked about AET, 70.8% reported a low level of concern about taking the therapy and 72.9% felt it was necessary. Of study participants, 27 (56.3%) omitted RT and initiated AET, 10 (20.8%) had RT and declined AET, 10 (20.8%) completed RT and initiated AET, and 1 (2.1%) declined RT and AET. Conclusions: This analysis shows that many early-stage ER+ breast cancer patients have a low level of worry about breast cancer recurrence, which may support treatment de-escalation such as RT omission. Most participants are open to taking AET despite the potential for side effects, yet historical data demonstrate low rates of adherence to AET. This discrepancy highlights that patients’ baseline beliefs about themselves and their medications may not align with their actual adherence. Future analysis from the POWER trial will examine how long-term AET adherence relates to baseline patient beliefs. Clinical trial information: NCT04272801 .

Financial toxicity (FT), quality of life (QoL), and medication adherence patient-reported outcomes (PROs) in CLL on first-line (1L) oral oncolytics.

e23157 Background: While oral oncolytics have transformed CLL treatment, high costs may cause significant FT adversely impacting patients beyond direct out-of-pocket (OOP) costs. The association of FT with QoL and medication adherence has not been characterized with oral oncolytics in CLL. Methods: Electronic PRO surveys were longitudinally administered to patients initiating any 1L oral oncolytic therapy for CLL within the last 6 months at two academic centers. PROs included FACIT-COST (significant FT: score &lt; 26), FACT-LEU QoL, MARS-5 (suboptimal adherence: score &lt; 25) and PROMIS PMAS to assess medication adherence. PROs were administered at baseline, 3 months, and 6 months after enrollment. Pearson’s correlation ( r) was calculated between PRO domains. Semi-structured, qualitative interviews were conducted after 3-month timepoints and analyzed. Results: 34 patients were enrolled: median age 65 yrs (range 33-80), 59% male, 6% Black, 9% Hispanic. Majority received BTK inhibitors (56%, acalabrutinib/zanubrutinib) followed by venetoclax (44%); 50% received concurrent obinutuzumab. Most had private insurance (50%) followed by Medicare (44%). Median time from 1L initiation to study enrollment: 1.5 months. PRO completion rates: 100% (baseline), 85% (3 mo) and 74% (6 mo). Summarized PRO and interview outcomes are displayed below. Conclusions: Patients with CLL on 1L oral oncolytics experienced worsening FT associated with poor medication adherence and worse QoL over time. PROs were discordant with qualitative interviews and suggested that FT may be driven by factors other than OOP costs. Although funding and patient assistance programs were beneficial, uncertainty over losing funding may be a long-term driver of FT and merits further study. [Table: see text]

The use of actigraphy to objectively define motion and function before and after shoulder arthroplasty

IntroductionActigraphy is a quantitative means of measuring activity data that has proven viable in post-surgery recovery analysis for arthroplasties in lower extremities, but scant literature has been published on the utilization actigraphy to evaluate shoulder motion and function before and after shoulder arthroplasty. The purpose of this prospective cohort study is to identify if actigraphy can serve as a valid means for objective evaluation of shoulder function and motion before and after shoulder arthroplasty. Secondarily, the data collected by the actigraphy can be analyzed with standard patient-reported outcomes to report correlations between the subjective and objective methods used in this study. Materials and methodsSixty-four subjects wore an actigraphy device for one day at pre-op, six, twelve and twenty-four weeks. In addition, subjects completed three patient-reported outcome surveys at each time-point. Student t-tests were used to compare percent activity preoperatively with 24-weeks and to compare PROs preoperatively with 24-week results; categorical variables were compared with one-way ANOVAs. ResultsAll Patient reported outcome scores significantly improved following arthroplasty (p-value<0.001). The percent of physical activity was highly correlated with vector magnitude (p-value<0.001), but neither percent activity or the vector magnitude were correlated with any of the PROs: UCLA Pain p-value = 0.656, SANE p-value = 0.328, UCLA Function p-value = 0.532. ConclusionsActigraphy results from this study mirror findings in previous literature utilizing the technology in similar manners and demonstrate its potential for motion and function analysis before and after total shoulder arthroplasties. Despite both being suitable methods independently for the evaluation of shoulder function, there was no significant correlation between standard actigraphy measurements and PROs at 24-weeks. Future research to determine clinical utility and an overall broader scope for actigraphy monitoring could benefit from improved technology, such as increased battery life for prolonged durations of data collection during observation periods.

Prospective Trial of Functional Lung Avoidance Radiation Therapy for Lung Cancer: Quality of Life Report

PurposeA novel form of lung function imaging has been developed that uses 4DCT data to generate lung ventilation images (4DCT-ventilation). Functional avoidance uses 4DCT-ventilation to reduce doses to functional lung with the aim of reducing pulmonary side-effects. A 4DCT-ventilation functional avoidance, phase II, multi-center clinical trial was completed. The purpose of this work is to quantify patient reported outcomes (PRO) changes for patients treated with functional avoidance and to determine which metrics are predictive of PRO changes. Materials and MethodsPatients with locally advanced lung cancer receiving curative intent radiotherapy were accrued. Each patient had a 4DCT-ventilation image generated using 4DCT data and image processing. PRO instruments included the Functional Assessment of Cancer Therapy-Lung (FACT-L) questionnaire, administered pre-treatment, 3, 6, and 12 months post-treatment. FACT-TOI (Trial Outcome Index) and the FACT-LCS (Lung Cancer Subscale) percentage of clinically meaningful declines (CMD) were determined. A linear mixed-effects model was used to determine which patient, clinical, dose, and dose-function metrics were predictive of PRO decline. Results59 patients completed baseline PRO surveys. 83% of patients had non-small-cell lung cancer, with 75% having stage III disease. The median dose was 60 Gy in 30 fractions. CMD FACT-TOI decline was 46.3%, 38.5%, and 26.8%, at 3, 6, and 12 months, respectively. CMD FACT-LCS decline was 33.3%, 33.3%, and 29.3%, at 3, 6, and 12 months, respectively. While an increase in most dose and dose-function parameters was associated with a modest decline in PROs, none of the results were significant (all p>0.053). ConclusionThe current work provides an innovative combination of functional avoidance and PROs and is the first report of PROs for patients treated with prospective 4DCT-ventilation functional avoidance. Approximately 30% of patients had clinically significant decline in PROs at 12 months. The study provides additional data on outcomes with 4DCT-ventilation functional avoidance.

Clubfoot Correction with Ponseti Technique: Three-Dimensional Alignment Analysis and Residual Adult Deformity Effects on Patient-Reported Outcomes

Introduction/Purpose: Few studies have assessed the long-term outcomes of the Ponseti technique and none have utilized 3- dimensional weightbearing analysis. The goal of this study was to understand how potential residual 3D deformities and abnormalities influence patient reported outcomes (PROs). This was accomplished by assessing anatomical foot and ankle alignment in adult clubfoot patients treated with the Ponseti method using 3D weightbearing CT (WBCT) imaging and then correlating residual foot and ankle malalignment with PROs. Methods: There were 37 consecutive patients (57 feet) included and 14 volunteers healthy controls (28 feet) included in this study. Every participant was evaluated using a WBCT (HiRise©) in a bipedal standing position. From these scans Cavus, Adductus, and Varus components were evaluated using multiple 3D measurements calculated using the semi-automatic segmentation software Bonelogic®. Specific Cavus related measurements included sagittal talus-first metatarsal angle and the calcaneal inclination angle. Varus related measurements included talocalcaneal angle in both the sagittal and axial planes as well as the hindfoot moment arm and the hindfoot alignment angle. Adductus deformity was evaluated using talonavicular coverage angle. These measurements were then correlated with patient reported outcome surveys, which included Visual Acuity Scale for pain, PROMIS general health, PROMIS physical function, PROMIS pain interference, pain catastrophic scale, and European foot and ankle society score. Results: There was no significant overall residual 3D-deformity observed in clubfoot patients when compared to controls, with similar FAO measurements observed between the groups, clubfoot=2.63% (95%CI=1.41%-3.85%) and control=3.2% (CI=1.6%- 4.8%,P=0.58). The sagittal talus-first-metatarsal in the clubfoot-patients had a mean-value of -0.12° compared to the controls, −5.2°. Clubfoot patients also had a decreased calcaneal-inclination-angle relative to the controls, 13.01° and 21.5° respectively. Talocalcaneal-angle for clubfoot patients in both the sagittal-plane,44.28°, and axial-plane, 17.74°, were reduced compared to the controls, 57.51° and 25.78°. Talonavicular-coverage-angle in the clubfoot-group (18.63°) was less than the controls (29.19°). Talus- first-metatarsal-angle in the sagittal-plane was significantly correlated with VAS-scores (RSquare=0.19,P=0.0118) and the EFAS- Score (RSquare=0.27,P=0.0025). Talocalcaneal-angle in the sagittal plane was also significantly correlated with the PROMIS-Pain- Interference-score (P=0.038) and PROMIS-Physical-Function-score (RSquare=0.32,P=0.0007). Conclusion: The Ponseti technique is an effective nonsurgical treatment for the overall three-dimensional foot and ankle alignment of Clubfoot. While mild, but statistically significant residual Varus and Adductus deformities were observed in adult clubfoot patients, the overall 3D alignment (FAO) was found to be similar between clubfoot patients and controls. These findings highlight the efficacy of the Ponseti technique and potentially explain the overall good PROs. The results of this study could potentially provide insight into treatment targets that may be applied to help optimize patient outcomes when treating children with Clubfoot in the future. The Ponseti technique is an effective nonsurgical treatment for Clubfoot's overall three-dimensional foot and ankle alignment. While mild, but statistically significant residual Varus and Adductus deformities were observed in adult clubfoot patients, the overall 3D alignment (FAO) was found to be similar between clubfoot patients and controls. These findings highlight the efficacy of the Ponseti technique and potentially explain the overall good PROs. The results of this study could potentially provide insight into treatment targets that may be applied to help optimize patient outcomes when treating children with Clubfoot in the future.

Cryoballoon pulmonary vein isolation versus radiofrequency ablation of the pulmonary veins and left atrial posterior wall: Patient-reported outcomes.

Data are lacking on patient-reported outcomes (PRO) following cryoballoon ablation (CBA) versus radiofrequency ablation (RFA). We sought to evaluate QoL and clinical outcomes of cryoballoon pulmonary vein isolation only (CRYO-PVI-ONLY) versus RFA with PVI and posterior wall isolation (RF-PVI+PWI) in a large prospective PRO registry. Patients who underwent AF ablation (2013-2016) at our institution were enrolled in an automated, prospectively maintained PRO registry. CRYO-PVI-ONLY patients were matched (1:1) with RF-PVI+PWI patients based on age, gender, and type of AF (paroxysmal vs. persistent). QoL and clinical outcomes were assessed using PRO surveys at baseline and at 1-year. The atrial fibrillation symptom severity scale (AFSSS) was the measure for QoL. Additionally, we assessed patient-reported clinical improvement, arrhythmia recurrence, and AF burden (as indicated by AF frequency and duration scores). A total of 296 patients were included (148 in each group, 72% paroxysmal). By PRO, a significant improvement in QoL was observed in the overall study population and was comparable between CRYO-PVI-ONLY and RF-PVI+PWI (baseline median AFSSS of 11.5 and 11; reduced to 2 and 4 at 1 year, respectively; p=0.44). Similarly, the proportion of patients who reported improvement in their overall QoL and AF related symptoms was high and similar between the study groups [92% (CRYO-PVI-ONLY) vs. 92.8% (RF-PVI+PWI); p=0.88]. Arrhythmia recurrence was significantly more common in the CRYO-PVI-ONLY group (39.7%) compared to RF-PVI+PWI (27.7 %); p=0.03. Comparable results were observed in paroxysmal and persistent AF. CRYO-PVI-ONLY and RF-PVI+PWI resulted in comparable improvements in patient reported outcomes including QoL and AF burden; with RF-PVI+PWI being more effective at reducing recurrences.

Association of Social Determinants with Patient-Reported Outcomes in Patients with Cancer.

Patient-reported outcome (PRO) scores have been utilized more frequently, but the relationship of PRO scores to determinants of health and social inequities has not been widely studied. Our goal was to determine the association of PRO scores with social determinants. All patients with a new cancer diagnosis who completed a PRO survey from 2020 to 2022 were included. The PRO survey recorded scores for depression, fatigue, pain interference and physical function. Higher depression, fatigue and pain scores indicated more distress. Higher physical condition scores indicated improved functionality. A total of 1090 patients were included. Married patients had significantly better individual PRO scores for each domain. Patients who were able to use the online portal to complete their survey also had better individual scores. Male patients and non-White patients had worse pain scores than female and White patients, respectively. Patients with prostate cancer had the best scores while patients with head and neck and lung cancer had the worst scores. PRO scores varied by cancer disease site and stage. Social support may act in combination with specific patient/tumor factors to influence PRO scores. These findings present opportunities to address patient support at institutional levels.

Can RESPiratory hospital Admissions in children with cerebral palsy be reduced? A feasibility randomised Controlled Trial pilot study protocol (RESP-ACT)

IntroductionThe most common cause of morbidity and mortality in children with severe cerebral palsy (CP) is respiratory disease. BREATHE-CP (Better REspiratory and Airway Treatment and HEalth in Cerebral Palsy) is...

EMBARK post hoc analysis of sexual activity (SA) patient-reported outcome (PRO) measures.

313 Background: In the phase 3 EMBARK trial (NCT02319837), enzalutamide (ENZ) + leuprolide (L) and ENZ monotherapy (mono) delayed metastasis-free survival (MFS) vs placebo (P) + L without impairing global health-related quality of life (HRQoL) in high-risk biochemically recurrent (BCR) nonmetastatic hormone-sensitive prostate cancer (nmHSPC) (PSA doubling time ≤9 months). A prespecified PRO analysis showed that SA (measured as a composite score using European Organization for Research and Treatment of Cancer QoL Questionnaire-Prostate 25 [QLQ-PR25]) was better preserved with ENZ mono vs P + L and no significant difference between ENZ + L vs P + L. A post hoc analysis at the HRQoL item level was conducted to understand the effect on SA in each comparison and enable shared decision-making between physicians and patients. Methods: Men with high-risk BCR nmHSPC were randomized (1:1:1) to ENZ + L (double blind), ENZ mono (open label), and P + L (double blind). HRQoL was assessed at baseline and every 12 weeks until metastasis/death. This post hoc analysis assessed effects on time to confirmed (two consecutive visits) deterioration (TTCD) using predefined thresholds of one category decline from baseline in sexual interest, activity, satisfaction, erectile function, and feeling like a man using QLQ-PR25 item 50; QLQ-PR25 item 51; FACT-P item GS7; FACT-P item BL5; and FACT-P item P5 measures, respectively (Table). Intent-to-treat principle was applied. Results: At baseline, 327–332 men per arm completed the PRO surveys; overall completion rates were ≥85%, except for GS7 (≤36% due to voluntary response). ENZ mono vs P + L : TTCD in items 50 (interest) and 51 (activity), GS7 (satisfaction), and BL5 (erectile function) was delayed with ENZ mono. ENZ + L vs P + L: no significant differences in TTCD were observed, except a shorter TTCD by a median 0.06 months in BL5 (erectile function) with ENZ + L (Table). Conclusions: This post hoc item-level analysis of the EMBARK trial confirmed that SA was better preserved with ENZ mono vs P + L in terms of interest, activity, satisfaction, and maintaining erection. Further, the SA PROs were similar between ENZ + L and P + L, implying there is no further SA burden when adding ENZ to androgen-deprivation therapy. Clinical trial information: NCT02319837 . [Table: see text]

Patient reported outcomes (PROs) and user experiences of young children with type 1 diabetes using t:slim X2 insulin pump with control-IQ technology

ObjectiveExamine patient-reported outcomes (PROs) after the use of t:slim X2 insulin pump with Control-IQ technology (CIQ) in young children with type 1 diabetes. MethodsChildren with type 1 diabetes, ages 2 to < 6 years (n = 102), were randomly assigned 2:1 to either CIQ or standard care (SC) with pump or multiple daily injections (MDI) plus continuous glucose monitoring (CGM) for 13 weeks. Both groups were offered to use CIQ for an additional 13 weeks after the randomized control trial’s (RCT) completion. Guardians completed PRO questionnaires at baseline, 13-, and 26-weeks examining hypoglycemia concerns, quality of life, parenting stress, and sleep. At 26 weeks, 28 families participated in user-experience interviews. Repeated measures analyses compared PRO scores between systems used. ResultComparing CIQ vs SC, responses on all 5 PRO surveys favored the CIQ group, showing that CIQ was superior to SC at 26 weeks (p values < 0.05). User-experience interviews indicated significant benefits in optimized glycemic control overall and nighttime control (28 of 28 families endorsed). All but 2/28 families noted substantial reduction in management burden resulting in less mental burden and all but 4 stated that they wanted their children to continue using CIQ. ConclusionsFamilies utilizing CIQ experienced glycemic benefits coupled with substantial benefits in PROs, documented in surveys and interviews. Families utilizing CIQ had reduced hypoglycemia concerns and parenting stress, and improved quality of life and sleep. These findings demonstrate the benefit of CIQ in young children with type 1 diabetes that goes beyond documented glycemic benefit.