Patient-reported Functional Status Research Articles

LC-ESI-MS/MS methods for the quantification of hydrazine mono lactose adduct and hydrazine di lactose adduct in isosorbide dinitrate and hydralazine hydrochloride tablets

Isosorbide dinitrate and hydralazine hydrochloride tablets treat heart failure in addition to conventional therapy, prolong hospitalization for heart failure, and enhance patient-reported functional status. LC-MS/MS methods developed and validated separately for the quantification of hydrazine mono-lactose adduct and hydrazine di-lactose adduct impurities in the isosorbide and hydralazine hydrochloride tablets. Separation of hydrazine mono-lactose adduct impurity achieved on ZIC-HILIC (100 × 4.6 mm, 5 µm) column with 0.1% formic acid in water as mobile phase A and acetonitrile as mobile phase B. The HPLC method gradient elution is; Tmin/% of B: 0/90, 15/40, 15.1/90, and 20/90. The flow rate is 1.0 mL per minute, and the injection volume is 20 µL. Separation of hydrazine di-lactose adduct impurity achieved on Inertsil HILIC (150 × 4.6 mm, 5 µm) column with 10 Mm ammonium acetate in water as mobile phase A and acetonitrile as mobile phase B. The HPLC method gradient elution is; Tmin/% of B: 0/90, 15/40, 15.1/90, and 18/90. The flow rate is 1.0 mL per minute, and the injection volume is 40 µL. Method validation has demonstrated both methods are specific, sensitive, linear, precise, accurate, stable and robust.

Special issue PRO] A demonstration of estimands and sensitivity analyses for time-to-deterioration of patient reported outcomes

ABSTRACT In oncology trials, health-related quality of life (HRQoL), specifically patient-reported symptom burden and functional status, can support the interpretation of survival endpoints, such as progression-free survival. However, applying time-to-event endpoints to patient-reported outcomes (PRO) data is challenging. For example, in time-to-deterioration analyses clinical events such as disease progression are common in many settings and are often handled through censoring the patient at the time of occurrence; however, disease progression and HRQoL are often related leading to informative censoring. Special consideration to the definition of events and intercurrent events (ICEs) is necessary. In this work, we demonstrate time-to-deterioration of PRO estimands and sensitivity analyses to answer research questions using composite, hypothetical, and treatment policy strategies applied to a single endpoint of disease-related symptoms. Multiple imputation methods under both the missing-at-random and missing-not-at-random assumptions are used as sensitivity analyses of primary estimands. Hazard ratios ranged from 0.52 to 0.66 over all the estimands and sensitivity analyses modeling a robust treatment effect favoring the treatment in time to disease symptom deterioration or death. Differences in the estimands include how people who experience disease progression or discontinue the randomized treatment due to AEs are accounted for in the analysis. We use the estimand framework to define interpretable and principled approaches for different time-to-deterioration research questions and provide practical recommendations. Reporting the proportions of patient events and patient censoring by reason helps understand the mechanisms that drive the results, allowing for optimal interpretation.

Integrating Patient-Reported Outcomes Into Prognostication in Gastroesophageal Cancer: Results of a Population-Based Retrospective Cohort Analysis.

Patient-reported outcomes measures (PROM) are self-reflections of an individual's physical functioning and emotional well-being. The Edmonton Symptom Assessment Scale (ESAS) is a simple and validated PRO tool of 10 common symptoms and a patient-reported functional status (PRFS) measure. The prognostic value of this tool is unknown in patients with gastroesophageal cancer (GEC). In this study, we examined the association between the ESAS score and overall survival (OS) in patients with GEC, the prognostication difference between ESAS and Eastern Cooperative Oncology Group (ECOG), and assessed the correlation between PRFS and the physician-reported ECOG performance status (PS). The study was a retrospective cohort study of 211 patients with GEC with localized (stages I-III) and metastatic disease who completed at least one baseline ESAS prior to treatment. Patients were grouped into 3 cohorts based on ESAS score. OS was assessed using the Kaplan-Meier method, and the concordance index (c-index) was calculated for ESAS and physician-reported ECOG. The agreement between PRFS and physician-ECOG was also assessed. In total, 211 patients were included. The median age was 60.8 years; 90% of patients were ECOG PS 0-1; 38% of patients were stages I-III, while 62% were de novo metastatic patients. Median OS in low, moderate, high symptom burden (SB) patients' cohorts was 19.17 m, 16.39 mm, and 12.68 m, respectively (P < .04). The ability to predict death was similar between physician-ECOG and ESAS (c-index 0.56 and 0.5753, respectively) and PRFS and physician-ECOG (c-index of 0.5615 and 0.5545, respectively). The PS agreement between patients and physicians was 50% with a weighted Kappa of 0.27 (95% CI: 0.17-0.38). Patient's SB seems to carry a prognostic significance. ESAS and physician-reported ECOG exhibit comparable prognostic values. Physicians and patients can frequently have divergent opinions on PS. ESAS takes a patient-centered approach and should be encouraged in practice among patients with GEC as an additional tool for prognostication.

Associations of current and childhood socioeconomic status and health outcomes amongst patients with knee or hip osteoarthritis in a Mexico City family-practice setting

ObjectivesTo examine the association of current and childhood socioeconomic status (SES) with patient-reported functional status, quality of life and disability in patients with knee or hip osteoarthritis (OA).MethodsCross-sectional study amongst individuals seeking care for any medical reason in a primary care family-practice clinic in Mexico City. We included individuals with self-reported doctor-diagnosed arthritis, recruited through waiting-room posters and invitations by treating family physicians. We administered a survey using validated Spanish language versions of the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), the Osteoarthritis of Lower Limbs and Quality of Life (AMICAL), and the Stanford Health Assessment Questionnaire-Disability Index (HAQ-DI). To estimate current and childhood SES, we collected data on education level and occupation type for both the patient and their parents, as well as using a validated tool to estimate income quintile.ResultsWe recruited 154 patients and excluded 8 patients. There was a high correlation between outcome scores. Estimated income and education levels were correlated with WOMAC, AMICAL and HAQ-DI scores, and significant differences were found in all scores by occupation type. The associations for current SES variables and outcome scores remained significant independently of age, sex, BMI, and presence of diabetes or hypertension, and were largely explained by current income in mutually adjusted models. Childhood SES – in particular as measured through maternal education – was best correlated with AMICAL scores, though its effect seemed largely mediated by its association with current SES.ConclusionsCurrent Socioeconomic Status impacts functional status, quality of life and disability amongst OA patients in Mexico City. The WOMAC, AMICAL and HAQ-DI scores correlate with each other and are all potentially useful markers of disease severity. More research is needed to elucidate the relationships between childhood SES and OA outcomes. Awareness of life-course SES may be useful in identifying patients at risk for worse outcomes.

Impact of pain and adverse health outcomes on long-term US testicular cancer survivors.

No study has quantified the impact of pain and other adverse health outcomes on global physical and mental health in long-term US testicular cancer survivors or evaluated patient-reported functional impairment due to pain. Testicular cancer survivors given cisplatin-based chemotherapy completed validated surveys, including Patient-Reported Outcomes Measurement Information System v1.2 global physical and mental health, Patient-Reported Outcomes Measurement Information System pain questionnaires, and others. Multivariable linear regression examined relationships between 25 adverse health outcomes with global physical and mental health and pain-interference scores. Adverse health outcomes with a β^ of more than 2 are clinically important and reported below. Among 358 testicular cancer survivors (median age = 46 years, interquartile range [IQR] = 38-53 years; median time since chemotherapy = 10.7 years, IQR = 7.2-16.0 years), median adverse health outcomes number was 5 (IQR = 3-7). A total of 12% testicular cancer survivors had 10 or more adverse health outcomes, and 19% reported chemotherapy-induced neuropathic pain. Increasing adverse health outcome numbers were associated with decreases in physical and mental health (P < .0001 each). In multivariable analyses, chemotherapy-induced neuropathic pain (β^ = -3.72; P = .001), diabetes (β^ = -4.41; P = .037), obesity (β^ = -2.01; P = .036), and fatigue (β^ = -8.58; P < .0001) were associated with worse global mental health, while being married or living as married benefited global mental health (β^ = 3.63; P = .0006). Risk factors for pain-related functional impairment included lower extremity location (β^ = 2.15; P = .04) and concomitant peripheral artery disease (β^ = 4.68; P < .001). Global physical health score reductions were associated with diabetes (β^ = -3.81; P = .012), balance or equilibrium problems (β^ = -3.82; P = .003), cognitive dysfunction (β^ = -4.43; P < .0001), obesity (β^ = -3.09; P < .0001), peripheral neuropathy score (β^ = -2.12; P < .0001), and depression (β^ = -3.17; P < .0001). Testicular cancer survivors suffer adverse health outcomes that negatively impact long-term global mental health, global physical health, and pain-related functional status. Clinically important factors associated with worse physical and mental health identify testicular cancer survivors requiring closer monitoring, counseling, and interventions. Chemotherapy-induced neuropathic pain must be addressed, given its detrimental impact on patient-reported functional status and mental health 10 or more years after treatment.

A comparison of acute patient-reported outcomes in breast cancer patients with and without regional nodal irradiation using the ESAS and PRFS tool

Regional nodal irradiation (RNI) is commonly administered in patients with breast cancer with node-positive disease to prevent cancer recurrence. The purpose of this study is to identify whether RNI is associated with greater acute symptom burden from baseline to 1 to 3months post completion of radiotherapy (RT) when compared to localized RT. Patient and treatment characteristics were collected prospectively for breast cancer patients with and without RNI from February 2018 to September 2020. The Edmonton Symptom Assessment System (ESAS) and Patient-Reported Functional Status (PRFS) tool were completed by patients at baseline, weekly during RT, and at a 1- to 3-month follow-up visit. The Wilcoxon rank-sum or Fisher exact tests were used to compare variables between patients with or without RNI. A total of 781 patients were included in the analysis. Baseline symptom reporting was similar between cohorts, with the exception of PRFS scores (p = 0.0023), which were worse in patients receiving RNI. Across all time points, differences in outcomes between cohorts were minimal, except for lack of appetite (p = 0.03) and PRFS scores (p = 0.049), which were significantly aggravated in patients treated with RNI. There is insufficient evidence to suggest that RNI is associated with greater symptom burden as assessed with the ESAS. Further research should be conducted over a longer time period to determine the impact of late effects of RNI on patient-reported symptoms.

Comparison of neoadjuvant versus adjuvant chemotherapy for breast cancer patients prior to receiving radiation therapy using Edmonton Symptom assessment system (ESAS) scores.

Patients undergoing radiotherapy (RT) for breast cancer may receive adjuvant or neoadjuvant chemotherapy prior to the initiation of RT treatment. In the present study, baseline Edmonton Symptom Assessment System (ESAS) scores of patients who received neoadjuvant and adjuvant chemotherapy were collected prior to RT and compared to assess the association of each chemotherapy intent with pre-RT symptom burden. The ESAS and Patient-Reported Functional Status (PRFS) tools were used to collect patient-reported symptoms at baseline. Patient and treatment-related factors were collected prospectively from February 2018 to September 2020. Univariate general linear regression analysis was applied to compare baseline scores between adjuvant and neoadjuvant chemotherapy patients. A total of 338 patients were included for analysis. Comparison of baseline ESAS scores revealed that patients who received adjuvant chemotherapy were more likely to report higher scores, reflecting higher symptom burden, compared to patients receiving neoadjuvant chemotherapy, including tiredness (p = 0.005), lack of appetite (p = 0.0005), shortness of breath (p < 0.0001), and PRFS (p = 0.012). This study suggests an association between patients who have received adjuvant chemotherapy for breast cancer and higher RT baseline ESAS scores when compared to patients who received neoadjuvant chemotherapy. Due to these findings, considerations should be made by healthcare providers of the symptom burden during RT for patients who receive adjuvant chemotherapy.

Outcome of bracing vs. surgical treatment in adolescents with idiopathic scoliosis based on device measured daily physical activity: a prospective pilot study.

Adolescent idiopathic scoliosis (AIS) can be treated with bracing or surgery, which may affect patient's physical activity (PA). However, there are limited objective assessments of PA in patients with AIS. This study aims to compare the outcome of spinal bracing vs. surgery in patients with AIS based on a device that measured daily PA. In total 24 patients with AIS participated, including 12 patients treated with bracing and 12 with spinal surgery. Daily PA was measured throughout 4 consecutive days using four tri-axial accelerometers and patient-reported functional status was reported using the SRS-22 questionnaire. The participants were assessed both before the treatment and after treatment at a 12-month follow-up. Patients with AIS had no significant change in their PA levels at the 12-month follow-up after surgical correction. On the contrary, patients with AIS following a year-long bracing treatment had significantly reduced time spent active ( P = 0.04) with an average reduction in walking steps by 2137 steps/day ( P = 0.005). There was no significant difference in function, pain, self-image and mental health domains following both treatments, as reported by the SRS-22. There was a significant improvement in satisfaction for both treatment groups ( P ≤ 0.02). Significantly reduced PA and increased sedentary time are reported in patients with AIS following bracing treatment. An objective PA assessment is recommended to track the effect of scoliosis treatment on PA. Patients with AIS should be actively encouraged to achieve and maintain their recommended daily PA levels irrespective of the type of treatment. Level of evidence: Level II.

Patient-Reported Frailty and Functional Status in Heart Failure With Preserved Ejection Fraction: Insights From VITALITY-HFpEF

BackgroundThe association between frailty and health status in patients with heart failure with preserved ejection fraction (HFpEF) is not well known. ObjectivesThe authors examined the association between: 1) patient-reported frailty, measured by the Fried frailty phenotype, Kansas City Cardiomyopathy Questionnaire Physical Limitation Score (KCCQ-PLS), 6-minute walking distance (6MWD), and other baseline characteristics; 2) baseline frailty compared with KCCQ-PLS and 24-week 6MWD; 3) frailty and changes in KCCQ-PLS and 6MWD; and 4) vericiguat and frailty at 24 weeks. MethodsIn a post hoc analysis, patients in the VITALITY-HFpEF (Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF) trial were categorized as not frail (0 symptoms), prefrail (1-2 symptoms), and frail (≥3 symptoms) according to patient-reported number of frailty symptoms. Correlations and linear regression models were used to examine the association between frailty and other measures, and between frailty and KCCQ-PLS at baseline with 24-week 6MWD. ResultsAmong 739 patients, 27.3% were not frail, 37.6% were prefrail, and 35.0% were frail at baseline. Frail patients were older, more likely to be women, and less likely to be from Asia. Baseline KCCQ-PLS and 6MWD (mean ± SD) among not frail, prefrail, and frail patients was 68.2 ± 23.2, 61.7 ± 22.6, and 48.4 ± 23.8 and 328.5 ± 117.1 m, 310.8 ± 98.9 m, and 250.7 ± 104.3 m (P < 0.01 for both). After accounting for baseline 6MWD, frailty status at baseline, but not KCCQ-PLS, was significantly associated with 6MWD at 24 weeks. By 24 weeks, 47.5% of patients had no change in frailty, 45.5% had become less frail, and 7.0% had become more frail. Treatment with vericiguat did not alter frailty status at 24 weeks. ConclusionsPatient-reported frailty is modestly correlated with both the KCCQ-PLS and 6MWD but offers prognostic insight into 6MWD at 24 weeks. (Patient-reported Outcomes in Vericiguat-treated Patients With HFpEF [VITALITY-HFpEF]; NCT03547583)

Mental Fatigue, Activities of Daily Living, Sick Leave and Functional Status among Patients with Long COVID: A Cross-Sectional Study.

Studies suggest that persistent symptoms after COVID-19 (long COVID) influence functioning and activities of daily living (ADL). However, it is still uncertain how and to what extent. This study aimed to describe patient-reported mental fatigue, ADL problems, ADL ability, sick leave and functional status among patients with long COVID. In this cross-sectional study, 448 patients, ≥18 years old and referred to occupational therapy at a Danish Post-COVID-19 Clinic, were included. Mental fatigue was measured by the Mental Fatigue Scale, ADL problems and ability were measured by the Canadian Occupational Performance Measure, sick leave was self-reported and functional status was evaluated by the Post-COVID-19 Functional Status Scale. Mean age was 46.8 years, 73% of the patients were female, and 75% suffered from moderate to severe mental fatigue. The majority reported difficulties performing productive and leisure activities. The median performance and satisfaction scores were 4.8 and 3, respectively. In total, 56% of the patients were on sick leave, and 94% were referred to rehabilitation. A decrease in functional status was found between pre-COVID-19 and assessment. Conclusively, the patients were highly affected in their everyday life and had distinct rehabilitation needs. Future research is needed to address causalities and rehabilitation for this patient group.

Optimizing Preventive Adjuvant Linac-Based (OPAL) Radiation: A Phase 2 Trial of Daily Partial Breast Irradiation

Evidence supports use of partial-breast irradiation (PBI) in the management of early breast cancer, but the optimal dose-fractionation remains unsettled. We conducted a phase 2 clinical trial (OPAL trial) to evaluate a novel PBI dosing schedule of 35 Gy in 10 daily fractions. Patients with close (<2 mm) margins also received a boost of 9 Gy in 3 fractions. Eligible patients underwent margin-negative lumpectomy for ductal carcinoma in situ or estrogen receptor-positive invasive breast cancer, up to 3 cm, pTis-T2 N0. The primary outcome was any grade ≥2 toxic effect occurring from the start of radiation through 6 months of follow-up. Secondary outcomes included patient-reported cosmesis, breast pain, and functional status, measured using the Breast Cancer Treatment Outcomes Scale, and physician-reported cosmesis, measured using the Radiation Therapy and Oncology Group scale. The Cochran-Armitage trend test and multivariable mixed-effects longitudinal growth curve models compared outcomes for the OPAL study population with those for a control group of similar patients treated with whole-breast irradiation (WBI) plus boost. All 149 patients enrolled on the OPAL trial received the prescribed dose, and 17.4% received boost. The median age was 64 years; 83.2% were White, and 73.8% were overweight or obese. With median follow-up of 2.0 years, 1 patient (0.7%) experienced in-breast recurrence. Prevalence of the primary toxicity outcome was 17.4% (26 of 149 patients) in the OPAL trial compared with 72.7% (128 of 176 patients) in the control WBI-plus-boost cohort (P < .001). In longitudinal multivariable analysis, treatment on the OPAL trial was associated with improved patient-reported cosmesis (P < .001), functional status (P=.004), breast pain (P=.004), and physician-reported cosmesis (P < .001). Treatment with daily PBI was associated with substantial reduction in early toxicity and improved patient- and physician-reported outcomes compared with WBI plus boost. Daily external-beam partial-breast irradiation with 13 or fewer fractions merits further prospective evaluation.

Prospective evaluation of social risks, physical function, and cognitive function in prediction of non-elective rehospitalization and post-discharge mortality

BackgroundIncreasing evidence suggests that social factors and problems with physical and cognitive function may contribute to patients’ rehospitalization risk. Understanding a patient’s readmission risk may help healthcare providers develop tailored treatment and post-discharge care plans to reduce readmission and mortality. This study aimed to evaluate whether including patient-reported data on social factors; cognitive status; and physical function improves on a predictive model based on electronic health record (EHR) data alone.MethodsWe conducted a prospective study of 1,547 hospitalized adult patients in 3 Kaiser Permanente Northern California hospitals. The main outcomes were non-elective rehospitalization or death within 30 days post-discharge. Exposures included patient-reported social factors and cognitive and physical function (obtained in a pre-discharge interview) and EHR–derived data for comorbidity burden, acute physiology, care directives, prior utilization, and hospital length of stay. We performed bivariate comparisons using Chi-square, t-tests, and Wilcoxon rank-sum tests and assessed correlations between continuous variables using Spearman’s rho statistic. For all models, the results reported were obtained after fivefold cross validation.ResultsThe 1,547 adult patients interviewed were younger (age, p = 0.03) and sicker (COPS2, p < 0.0001) than the rest of the hospitalized population. Of the 6 patient-reported social factors measured, 3 (not living with a spouse/partner, transportation difficulties, health or disability-related limitations in daily activities) were significantly associated (p < 0.05) with the main outcomes, while 3 (living situation concerns, problems with food availability, financial problems) were not. Patient-reported cognitive (p = 0.027) and physical function (p = 0.01) were significantly lower in patients with the main outcomes. None of the patient-reported variables, singly or in combination, improved predictive performance of a model that included acute physiology and longitudinal comorbidity burden (area under the receiver operator characteristic curve was 0.716 for both the EHR model and maximal performance of a random forest model including all predictors).ConclusionsIn this insured population, incorporating patient-reported social factors and measures of cognitive and physical function did not improve performance of an EHR-based model predicting 30-day non-elective rehospitalization or mortality. While incorporating patient-reported social and functional status data did not improve ability to predict these outcomes, such data may still be important for improving patient outcomes.

Long-term patient-reported outcomes after non–small cell lung cancer resection

ObjectivesPatient-reported outcomes (PROs) are critical tools for evaluating patients before and after lung cancer resection. In this study, we assessed patient-reported pain, dyspnea, and functional status up to 1 year postoperatively. MethodsThis study included patients who underwent surgery for non–small cell lung cancer at a single institution (2017-2020). We collected PROs using the National Institutes of Health Patient Reported Outcome Measurement Information System (PROMIS). Data were prospectively collected and merged with our institutional Society of Thoracic Surgeons data. Using multivariable linear mixed effect models, we compared PROMIS scores for preoperative and several postoperative visits. ResultsFrom 2017 until 2020, 334 patients underwent lung cancer resection with completed PROMIS assessments. Pain interference, physical function, and dyspnea severity scores were worse 1 month after surgery (P < .001). Pain interference and physical function scores returned to baseline by 6 months after surgery. However, dyspnea severity scores remained persistently worse up to 1 year after surgery (1-month difference, 8.8 ± 1.9; 6-month difference, 3.6 ± 2.2; 1-year difference, 4.9 ± 2.8; P < .001). Patients who received a thoracotomy had worse physical function and pain interference scores 1 month after surgery compared with patients who received a minimally invasive operation; however, there were no differences in PROs by 6 months after surgery. ConclusionsPROs are important metrics for assessing patients before and after lung cancer resection. Patients may report persistent dyspnea up to 1 year after resection. Additionally, patients undergoing thoracotomy initially report worse pain and physical function but these impairments improve by 6 months after surgery.

Abstract P4-10-22: Patient reported symptoms and functional status in breast cancer

Abstract Background: To improve symptom management in cancer patients, the province of Ontario (Canada) implemented the collection of the Edmonton Symptom Assessment System (ESAS) and Patient-Reported Functional Status (PRFS) tool at cancer centre outpatient visits. ESAS measures 9 symptoms on a scale from 0 (no symptoms) to 10 (worst possible symptom); scores &amp;gt; 4 (moderate to severe) require intervention. The PRFS tool is a version of the Eastern Cooperative Oncology Group performance status tool designed to be completed by the patient; scores range from 0 (“normal with no limitation”) to 4 (“pretty much bedridden, rarely out of bed”). Our main objective was to describe the symptom burden and functional status of breast cancer (BC) patients.Methods: This cross-sectional study included women with stage I-IV BC who completed the ESAS and the PRFS tool during outpatient clinic visits at 2 Toronto academic centres. ESAS and PRFS scores were described for 3 participant groups: women diagnosed with early-stage BC (ESBC= stages I-III) in the year prior to enrolment; women with ESBC diagnosed &amp;gt; 1 year prior to enrolment; and women with metastatic BC. Multivariable logistic regression models were used to identify factors associated with ESAS scores &amp;gt; 4 for each ESAS symptom. Covariates included age, comorbidity, BC subtype, disease group, previous surgery, and current systemic therapy. Results: Of 381 women, 107 (28%) were diagnosed with ESBC ≤ 1 year prior to enrolment; 171 (45%) were diagnosed with ESBC &amp;gt; 1 year prior to enrolment; 103 (27%) had metastatic BC. Mean age was 57 (SD17) years. For ESBC, tiredness had the highest incidence of moderate to severe scores, followed by impaired well-being and anxiety (Table 1). For metastatic BC, impaired well-being had the highest incidence of moderate to severe symptoms, followed by tiredness and anxiety. More than 20% of metastatic BC patients had scores &amp;gt; 4 for pain, drowsiness, shortness of breath and depression. Most reported PRFS scores of 0 (“Normal with no limitations”) or 1 (“Not my normal self, but able to be up and about with fairly normal activities”), but 17% of metastatic BC patients reported a PRFS of 2 (“Not feeling up to most things, but in bed or chair less than half the day”). A comorbidity score ≥1 was associated with moderate to severe depression (OR 2.0; 95%CI 1.1-3.7), lack of appetite (OR 3.1; 95%CI 1.4-6.6), shortness of breath (OR 2.6; 95%CI 1.3-5.2), tiredness (OR 2.0; 95%CI 1.2-3.3) and impaired well-being (OR 2.0; 95%CI 1.2-3.4). Metastatic BC was associated with moderate to severe scores for anxiety (OR 2.3; 95%CI 1.2-4.5), pain (OR 3.0; 95%CI 1.4-6.4) and impaired well-being (OR 2.1; 95%CI 1.1-4.0). Conclusion: A high prevalence of symptom scores &amp;gt; 4 was found both in ESBC and metastatic BC, highlighting the need of symptom screening for all BC patients. Particular attention should be paid to patients with comorbidity scores ≥ 1, who have increased odds of presenting higher symptom scores. Table 1.- Prevalence of ESAS scores ≥ 4 and PRFS scores for each disease group.ESAS SymptomsPercent with ESAS scores ≥ 4 (moderate to severe)Early-Stage Breast Cancer – 1st year (N=107)Early-Stage Breast Cancer – &amp;gt; 1st year (N=171)Metastatic Breast Cancer (N=103)Total (N=381)Pain12.1%14.7%30.1%18.2%Tiredness25.2%30.1%39.8%31.3%Drowsiness1.8%12.9%25.2%16.6%Nausea9.4%3.5%7.8%4.2%Lack of Appetite10.3%7.1%13.6%9.5%Shortness of Breath14%7.6%22.3%12.4%Depression17.7%14.6%22.6%16.5%Anxiety24.3%17.2%35.3%21.3%Well-being1.8%25.7%44.1%30.3%PRFS scoresPercent with PRFS ScoreNormal with no limitations (0)30.8%49.7%28.2%38.6%Not my normal self, but able to be up and about with fairly normal activities (1)52.3%42.1%50.5%47.2%Not feeling up to most things, but in bed or chair less than half the day (2)12.2%4.7%16.5%10%Able to do little activity and spend most of the day in bed or chair (3)3.7%2.3%4.9%3.4%Pretty much bedridden, rarely out of bed (4)---- Citation Format: Sofia Torres, Ahmed Bayoumi, Geoffrey Liu, Ana Beatriz Kinupe Abrahao, Nicholas Mitsakakis, Murray Krahn, Maureen Trudeau. Patient reported symptoms and functional status in breast cancer [abstract]. In: Proceedings of the 2021 San Antonio Breast Cancer Symposium; 2021 Dec 7-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2022;82(4 Suppl):Abstract nr P4-10-22.

Adherence to the mediterranean diet is associated with patient-reported functional status in rheumatoid arthritis

Rationale: Rheumatoid arthritis (RA) is a chronic inflammatory disease that leads to functional disability. Dietary interventions have been proposed to minimize the consequences of the disease in patients with RA. This study aims to assess the relationship between Adherence to the Mediterranean Diet (AdhMD), functional status and impact of disease in RA.

Quality of life, psychological resilience, personality traits and illness perception in grown-up congenital heart patients in Hong Kong

BackgroundStudies suggested heterogeneity of physical and psychological predictors of quality of life (QOL) among congenital heart disease patients. This cross-sectional study aimed to examine the interrelationships of QOL, health status, resilience, personality traits, illness perception, and clinical data of grown-up congenital heart (GUCH) patients in a tertiary center in Hong Kong. MethodsGUCH patients (N ​= ​208, male ​= ​103) were invited to complete self-report questionnaires: 36-item Short Form Health Survey version 2 (SF36), Satisfaction with Life Scale (SWLS), Connor-Davidson Resilience Scale (RISC), Hospital Anxiety and Depression Scale (HADS), and NEO Five Factor Inventory (NEOFFI-3); results on these measures were compared to 104 healthy peers. GUCH patients also completed Brief Illness Perception Questionnaire (BIPQ). Disease complexity, illness severity, New York Heart Association (NYHA) class and Warnes-Somerville Ability Index (WSAI) grades of patients were obtained. The interrelationships between these patient-reported outcome (PRO) measures, clinical indices and functional status were assessed. ResultsQOL scores and health status were lower in GUCH patients than healthy peers, and were associated with greater disease severity and worse functional class (all p-values < 0.01). SWLS and health status correlated positively with RISC, but negatively with HADS and negative illness perception (all p ​< ​0.001). In multivariate regression, lower RISC, negative illness perception, and greater neuroticism were predictors of lower SWLS (all p ​< ​0.05); higher WSAI grade, lower RISC and negative illness perception were predictors of lower PCS (all p ​< ​0.05); and greater neuroticism and HADS were predictors of lower MCS (all p ​< ​0.01). ConclusionsReduced QOL and health status among GUCH patients were associated with both clinical and psychological attributes. Resilience and illness perception might be the potential targets of intervention.

Optimizing Preventive Adjuvant LINAC (OPAL) Radiation: A Phase II Trial of Daily Partial Breast Irradiation

<h3>Purpose/Objective(s)</h3> Twice daily accelerated partial breast irradiation (APBI) may confer worse long-term cosmetic outcome than daily whole breast irradiation (WBI). We hypothesized that daily partial breast irradiation would yield improved cosmetic outcomes without compromising tumor control. To test this hypothesis, we conducted a phase II trial to evaluate a ten-fraction regimen of daily PBI (OPAL regimen). <h3>Materials/Methods</h3> From 2017-2018, 149 women aged ≥ 50 with DCIS or early invasive, ER+ breast cancer were enrolled into a multi-institutional phase II trial that treated the partial breast to 35 Gy in 10 daily fractions. Patients with close margins (< 2 mm) also received a boost of 9 Gy in 3 daily fractions. Toxicities were evaluated using CTCAE v4.0 and physician-reported cosmesis was assessed using the RTOG scale. The Breast Cancer Treatment Outcomes Scale (BCTOS) assessed patient-reported cosmesis, breast pain, and functional status. Outcomes were assessed at baseline, 6 months, 1 year, and annually thereafter. The primary outcome was incidence of grade ≥ 2 toxicity within 6 months of PBI initiation. To facilitate a comparison of the OPAL regimen to WBI, we identified 176 patients with similar clinical-pathologic features from our prior trial of WBI+boost in which toxicities were also prospectively collected. Differences in cross-sectional outcomes between the OPAL trial and historical WBI+boost cohort were tested using chi-square test. Mixed effect growth curve models evaluated outcomes over time adjusting for relevant covariates. <h3>Results</h3> Median age was 64 years and median follow-up was 2 years. All 149 patients received 35 Gy in 10 daily fractions and 26 received a boost. One patient developed an in-field DCIS recurrence. For the primary outcome, grade ≥ 2 toxicity within 6 months of PBI initiation was 14.1% with OPAL compared to 71% in the WBI+boost cohort (<i>P</i> < 0.001). At two years post-radiation, fatigue (8% vs 16%), hyperpigmentation (18% vs 30%), breast edema (0% vs 9%), superficial fibrosis (18% vs 31%), deep fibrosis (6% vs 13%), nipple areolar changes (6% vs 17%), and breast atrophy (19% vs 35%) were less prevalent in patients treated with OPAL (all <i>P</i> < 0.05). At two years, 93% of patients treated with OPAL had excellent/good cosmetic outcome compared to 77% of patients treated with WBI+boost (<i>P</i> < 0.001). In multivariable longitudinal analysis, treatment with OPAL was associated with improved patient-reported cosmetic outcome (<i>P</i> < 0.001), functional status (<i>P</i> = 0.02), breast pain (<i>P</i> = 0.003) and physician-reported cosmetic outcome (<i>P</i> < 0.001). <h3>Conclusion</h3> Treatment with this novel daily PBI regimen of 35 Gy in 10 daily fractions with selective boost yielded better cosmetic and functional outcomes and less breast pain and toxicity than WBI+boost with median follow up of 2 years. Daily external beam partial breast irradiation with 10 or fewer fractions merits further prospective evaluation.

Patient-reported Outcomes Among Vulnerable Populations in the Medicare Bundled Payments for Care Improvement Initiative.

The Centers for Medicare & Medicaid Services Bundled Payments for Care Improvement (BPCI) initiative tested whether episode-based payment models could reduce Medicare payments without harming quality. Among patients with vulnerabilities, BPCI appeared to effectively reduce payments while maintaining the quality of care. However, these findings could overlook potential adverse patient-reported outcomes in this population. We surveyed beneficiaries with 4 characteristics (Medicare-Medicaid dual eligibility; dementia; recent institutional care; or racial/ethnic minority) treated at BPCI-participating or comparison hospitals for congestive heart failure, sepsis, pneumonia, or major joint replacement of the lower extremity. We estimated risk-adjusted differences in patient-reported outcomes between BPCI and comparison respondents, stratified by clinical episode and vulnerable characteristic. Patient care experiences during episodes of care and patient-reported functional outcomes assessed roughly 90 days after hospitalization. We observed no differences in self-reported functional improvement between BPCI and comparison respondents with vulnerable characteristics. Patient-reported care experience was similar between BPCI and comparison respondents in 11 of 15 subgroups of clinical episode and vulnerability. BPCI respondents with congestive heart failure, sepsis, and pneumonia were less likely to indicate positive care experiences than comparison respondents for at least 1 subgroup with vulnerabilities. As implemented by hospitals, BPCI Model 2 was not associated with adverse effects on patient-reported functional status among beneficiaries who may be vulnerable to reductions in care. Hospitals participating in heart failure, sepsis or pneumonia bundled payment episodes should focus on patient care experience while implementing changes in care delivery.

Bundled Payment Episodes Initiated by Physician Group Practices: Medicare Beneficiary Perceptions of Care Quality.

The Bundled Payments for Care Improvement (BPCI) initiative incentivizes participating providers to reduce total Medicare payments for an episode of care. However, there are concerns that reducing payments could reduce quality of care. To assess the association of BPCI with patient-reported functional status and care experiences. We surveyed a stratified random sample of Medicare beneficiaries with BPCI episodes attributed to participating physician group practices, and matched comparison beneficiaries, after hospitalization for one of the 18 highest volume clinical episodes. The sample included beneficiaries discharged from the hospital from February 2017 through September 2017. Beneficiaries were surveyed approximately 90 days after their hospital discharge. We estimated risk-adjusted differences between the BPCI and comparison groups, pooled across all 18 clinical episodes and separately for the five largest clinical episodes. Medicare beneficiaries with BPCI episodes (n=16,898, response rate=44.5%) and comparison beneficiaries hospitalized for similar conditions selected using coarsened exact matching (n=14,652, response rate=46.2%). Patient-reported functional status, care experiences, and overall satisfaction with recovery. Overall, we did not find differences between the BPCI and comparison respondents across seven measures of change in functional status or overall satisfaction with recovery. Both BPCI and comparison respondents reported generally positive care experiences, but BPCI respondents were less likely to report positive care experience for 3 of 8 measures (discharged at the right time, -1.2 percentage points (pp); appropriate level of care, -1.8 pp; preferences for post-discharge care taken into account, -0.9 pp; p<0.05 for all three measures). The proportion of respondents with favorable care experiences was smaller for BPCI than comparison respondents. However, we did not detect differences in self-reported change in functional status approximately 90 days after hospital discharge, indicating that differences in care experiences did not affect functional recovery.

Burden of Kidney Disease, Health-Related Quality of Life, and Employment Among Patients Receiving Peritoneal Dialysis and In-Center Hemodialysis: Findings From the DOPPS Program

Individuals faced with decisions regarding kidney replacement therapy options need information on how dialysis treatments might affect daily activities and quality of life, and what factors might influence the evolution over time of the impact of dialysis on daily activities and quality of life. Observational cohort study. 7,771 hemodialysis (HD) and peritoneal dialysis (PD) participants from 6 countries participating in the Peritoneal and Dialysis Outcomes and Practice Patterns Studies (PDOPPS/DOPPS). Patient-reported functional status (based on daily living activities), country, demographic and clinical characteristics, and comorbidities. Employment status and patient-reported outcomes (PROs) including Kidney Disease Quality of Life (KDQOL) instrument physical and mental component summary scores (PCS, MCS), kidney disease burden score, and depression symptoms (Center for Epidemiologic Studies Depression Scale [CES-D] score > 10). Linear regression (PCS, MCS, kidney disease burden score), logistic regression (depression symptoms), adjusted for predictors plus 12 additional comorbidities. In both dialysis modalities, patients in Japan had the highest PCS and employment (55% for HD and 68% for PD), whereas those in the United States had the highest MCS score, lowest kidney disease burden, and lowest employment (20% in HD and 42% in PD). After covariate adjustment, the association of age, sex, dialysis vintage, diabetes, and functional status with PROs was similar in both modalities, with women having lower PCS and kidney disease burden scores. Lower functional status (score<11) was strongly associated with lower PCS and MCS scores, a much greater burden of kidney disease, and greater likelihood of depression symptoms (CES-D, >10). The median change in KDQOL-based PROs was negligible over 1 year in participants who completed at least 2 annual questionnaires. Selection bias due to incomplete survey responses. Generalizability was limited to the dialysis populations of the included countries. Variation exists in quality of life, burden of kidney disease, and depression across countries but did not appreciably change over time. Functional status remained one of the strongest predictors of all PROs. Routine assessment of functional status may provide valuable insights for patients and providers in anticipating outcomes and support needs for patients receiving either PD or HD.