Validation of Patient-Reported Outcomes in Patients With Nonmetastatic Breast Cancer Receiving Comprehensive Nodal Irradiation in the RadComp Trial.

PURPOSE: Our purpose was to evaluate the measurement properties of patient-reported outcome (PRO) measures used in the ongoing RadComp pragmatic randomized clinical trial (PRCT). METHODS AND MATERIALS: The deidentified and blinded data set included 774 English-speaking female participants who completed their 6-month posttreatment assessment. Eleven PRO measures were evaluated, including the Trial Outcome Index from the Functional Assessment of Cancer Therapy-Breast (FACT-B), Satisfaction with Breast Cosmetic Outcomes, the BREAST-Q, and selected Patient-Reported Outcomes Measurement Information System (PROMIS) measures. PROs were measured at 3 timepoints: baseline, completion of radiation therapy (RT), and 6 months post-RT. Ten variables were used as validity anchors. Pearson or Spearman correlations were calculated between PROs and convergent validity indicators. Mean PRO differences between clinically distinct categories were compared with analysis of variance methods (known-groups validity). PRO change scores were mapped to change in other variables (sensitivity to change). RESULTS: Most correlations between PROs and validity indicators were large (≥0.5). Mean score for Satisfaction with Breast Cosmetic Outcomes was higher (better) for those with a lumpectomy compared with those with a mastectomy (P < .001). Mean scores for the FACT-B Trial Outcome Index and for PROMIS Fatigue and Ability to Participate in Social Roles and Activities were better for those with good baseline performance status compared with those with poorer baseline performance status (P < .05). At completion of RT and post-RT, mean scores for Satisfaction with Breast Cosmetic Outcomes and BREAST-Q Radiation were significantly different (P < .001) across categories for all Functional Assessment of Chronic Illness Therapy -Treatment Satisfaction - General items. There were medium-sized correlations between change scores for FACT-B Trial Outcome Index, Fatigue, Anxiety, and Ability to Participate in Social Roles and change scores in the Visual Analog Scale. CONCLUSIONS: For patients with nonmetastatic breast cancer receiving radiation in the RadComp PRCT, our findings demonstrate high reliability and validity for important PRO measures, supporting their psychometric strength and usefulness to reflect the effect of RT on health-related quality of life.

PROMIS: Physical, Mental and Social Health Outcomes Improve From Before to Early After LVAD Implant: Findings From the Mechanical Circulatory Support: Measures of Adjustment and Quality of Life (MCS A-QOL) Study.

Study participants (n = 272) completed 12 Patient-Reported Outcomes Measurement Information System (PROMIS) physical, mental and social health measures (questionnaires) prior to implantation of a left ventricular assist device (LVAD) and again at 3 and 6 months postimplant. All but 1 PROMIS measure demonstrated significant improvement from pre-implant to 3 months; there was little change between 3 and 6 months. Because PROMIS measures were developed in the general population, patients with an LVAD, their caregivers and their clinicians can interpret the meaning of PROMIS scores in relation to the general population, helping them to monitor a return to normalcy in everyday life.

Validity of Patient-Reported Outcomes Measurement Information System Physical, Mental, and Social Health Measures After Left Ventricular Assist Device Implantation and Implications for Patient Care.

BACKGROUND: A better understanding is needed of the burdens and benefits of left ventricular assist device (LVAD) implantation on patients' physical, mental, and social well-being. The purpose of this report was to evaluate the validity of Patient-Reported Outcomes Measurement Information System (PROMIS) measures for LVAD patients and to estimate clinically important score differences likely to have implications for patient treatment or care. METHODS: Adults from 12 sites across all US geographic regions completed PROMIS measures ≥3 months post-LVAD implantation. Other patient-reported outcomes (eg, Kansas City Cardiomyopathy Questionnaire-12 item), clinician ratings, performance tests, and clinical adverse events were used as validity indicators. Criterion and construct validity and clinically important differences were estimated with Pearson correlations, ANOVA methods, and Cohen d effect sizes. RESULTS: Participants' (n=648) mean age was 58 years, and the majority were men (78%), non-Hispanic White people (68%), with dilated cardiomyopathy (55%), long-term implantation strategy (57%), and New York Heart Association classes I and II (54%). Most correlations between validity indicators and PROMIS measures were medium to large (≥0.3; p<0.01). Most validity analyses demonstrated medium-to-large effect sizes (≥0.5) and clinically important differences in mean PROMIS scores (up to 14.8 points). Ranges of minimally important differences for 4 PROMIS measures were as follows: fatigue (3-5 points), physical function (2-3), ability to participate in social roles and activities (3), and satisfaction with social roles and activities (3-5). CONCLUSIONS: The findings provide convincing evidence for the relevance and validity of PROMIS physical, mental, and social health measures in patients from early-to-late post-LVAD implantation. Findings may inform shared decision-making when patients consider treatment options. Patients with an LVAD, their caregivers, and their clinicians should find it useful to interpret the meaning of their PROMIS scores in relation to the general population, that is, PROMIS may help to monitor a return to normalcy in everyday life.

The Role of Disordered Eating in Type 2 Diabetes: A Pilot Study.

Rates of type 2 diabetes mellitus continue to rise around the world, largely due to lifestyle factors such as poor diet, overeating, and lack of physical activity. Diet and eating is often the most challenging aspect of management and, when disordered, has been associated with increased risk for diabetes-related complications. Thus, there is a clear need for accessible and evidence-based interventions that address the complex lifestyle behaviors that influence diabetes management. The current study sought to assess the efficacy and acceptability of a pilot lifestyle intervention for women with type 2 diabetes and disordered eating. The intervention followed a cognitive behavioral therapy guided-self-help (CBTgsh) model and included several pillars of lifestyle medicine, including: diet, exercise, stress, and relationships. Ten women completed the 12-week intervention that provided social support, encouraged physical activity, and addressed eating behaviors and cognitions. Results indicate the lifestyle intervention was a feasible treatment for disordered eating behaviors among women with type 2 diabetes and was also associated with improved diabetes-related quality of life. The intervention was also acceptable to participants who reported satisfaction with the program. The current CBTgsh lifestyle intervention is a promising treatment option to reduce disordered eating and improve diabetes management.

Analysis of Diversity, Equity, and Inclusion Initiatives Presented Across US Academic Department of Surgery Websites in 2021.

Despite increased attention devoted to diversity, equity, and inclusion (DEI) within academic medicine, representation, lack of workforce and leadership diversity, and bias within medicine remain persistent problems. The purpose of the current study was to understand the current efforts and attention to DEI within academic departments of surgery in the United States. 251 department of surgery websites were reviewed, using a standardized data collection form and scoring procedure, accompanied by a 10 percent fidelity check by an independent reviewer. Only 16% of departments of surgery included DEI-specific information, such as a DEI mission statement or initiatives on their departmental sites, with less than seven percent of departments reporting a DEI committee. Such public information may have implications for recruitment and retention of diverse faculty and trainees, downstream effects for patient care, and could be critical to public accountability to improve diversity and create a culture of equity and inclusion.

Value, implementation, and opportunities for cardiovascular behavioral medicine: A special issue commentary.

Behavioral and psychosocial factors related to the incidence, progression, and treatment of cardiovascular health, have seen increased attention in recent years, from scientific statements to a robust and growing body of literature. Despite this attention, and clear need to prevent and treat cardiovascular disease (CVD) the world over, implementation of cardiovascular behavioral medicine, specialty care that addresses behavioral and psychosocial risk factors among those with, or at risk for, CVD, remains limited. The current commentary discusses the contributions of the diverse body of science published in the Cardiovascular Behavioral Medicine Special Issue of Health Psychology. The authors outline how the special issue articles highlight the value of behavioral medicine education, science, and clinical practice for cardiology and cardiovascular subspecialities, such as heart failure, as well as opportunities for growth and implementation. This commentary outlines the ways in which the special issue furthers understanding of the current and future possibilities for cardiovascular behavioral medicine to grow as a field and influence cardiovascular health and wellbeing. (PsycInfo Database Record (c) 2022 APA, all rights reserved).

Cardiac behavioral medicine following heart transplant: A novel integrated care clinic model.

OBJECTIVE: Life after transplant is often accompanied by a myriad of psychosocial and behavioral factors, such as medication adherence and depression, that impact quality of life and outcomes, including mortality. The current project sought to expand the breadth of psychosocial and behavioral care provided to heart transplant recipients during routine follow-up care within a heart transplant clinic housed within an urban academic medical center. METHOD: A weekly half-day model of Cardiac Behavioral Medicine clinic integration (CBM-CI) was developed and implemented within an ongoing heart transplant clinic based off the primary care behavioral health (PCBH) model. After meetings with key leadership, the model was developed during a 3-week pilot, after which, clinic providers' expectations for integration were assessed. After the development phase, the CBM-CI was implemented into the weekly heart transplant clinic and a quality improvement (QI) process was engaged for the first 6 weeks. RESULTS: Across 6 weeks of clinic implementation, 19 patients engaged with a behavioral medicine provider during routine transplant follow-up, with a wide range of psychosocial/behavioral issues. Overall, the CBM-CI was well-received, the integration was in many ways feasible, and the QI process allowed for iterative improvement that addressed issues related to space, scheduling, selection of patient served, and communication. CONCLUSIONS: The CBM-CI for heart transplant enhances opportunity to address psychosocial and behavioral factors that negatively impact outcomes in all stages after heart transplant and highlights the unique role and contributions of clinical health psychologists in cardiology. (PsycInfo Database Record (c) 2022 APA, all rights reserved).