Pragmatic randomised clinical trial of proton versus photon therapy for patients with non-metastatic breast cancer: The Radiotherapy Comparative Effectiveness (RadComp) Consortium trial protocol

INTRODUCTION: A broad range of stakeholders have called for randomised evidence on the potential clinical benefits and harms of proton therapy, a type of radiation therapy, for patients with breast cancer. Radiation therapy is an important component of curative treatment, reducing cancer recurrence and extending survival. Compared with photon therapy, the international treatment standard, proton therapy reduces incidental radiation to the heart. Our overall objective is to evaluate whether the differences between proton and photon therapy cardiac radiation dose distributions lead to meaningful reductions in cardiac morbidity and mortality after treatment for breast cancer. METHODS: We are conducting a large scale, multicentre pragmatic randomised clinical trial for patients with breast cancer who will be followed longitudinally for cardiovascular morbidity and mortality, health-related quality of life and cancer control outcomes. A total of 1278 patients with non-metastatic breast cancer will be randomly allocated to receive either photon or proton therapy. The primary outcomes are major cardiovascular events, defined as myocardial infarction, coronary revascularisation, cardiovascular death or hospitalisation for unstable angina, heart failure, valvular disease, arrhythmia or pericardial disease. Secondary endpoints are urgent or unanticipated outpatient or emergency room visits for heart failure, arrhythmia, valvular disease or pericardial disease. The Radiotherapy Comparative Effectiveness (RadComp) Clinical Events Centre will conduct centralised, blinded adjudication of primary outcome events. ETHICS AND DISSEMINATION: The RadComp trial has been approved by the institutional review boards of all participating sites. Recruitment began in February 2016. Current version of the protocol is A3, dated 08 November 2018. Dissemination plans include presentations at scientific conferences, scientific publications, stakeholder engagement efforts and presentation to the public via lay media outlets. TRIAL REGISTRATION NUMBER: NCT02603341

"Call a Teenager… That's What I Do!" - Grandchildren Help Older Adults Use New Technologies: Qualitative Study.

BackgroundAlthough family technical support seems intuitive, there is very little research exploring this topic.ObjectiveThe objective of this study was to conduct a subanalysis of data collected from a large-scale qualitative project regarding older adults' experiences in using health information technology. Specifically, the subanalysis explored older adults' experiences with technology support from family members to inform strategies for promoting older adults' engagement with new health technologies. Although the primary analysis of the original study was theoretically driven, this paper reports results from an inductive, open-coding analysis.MethodsThis is a subanalysis of a major code identified unexpectedly from a qualitative study investigating older adults' use experience of a widespread health technology, the patient portal. A total of 24 older patients (≥65 years) with multiple chronic conditions (Charlson Comorbidity Index >2) participated in focus groups conducted at the patients' primary clinic. While conducting the primary theoretically driven analysis, coders utilized an open-coding approach to ensure important ideas not reflected in the theoretical code book were captured. Open coding resulted in 1 code: family support. This subanalysis further categorized family support by who provided tech support, how tech support was offered, and the opinions of older participants about receiving family tech support.ResultsThe participants were not specifically asked about family support, yet themes around family assistance and encouragement for technology emerged from every focus group. Participants repeatedly mentioned that they called their grandchildren and adult children if they needed help with technology. Participants also reported that family members experienced difficulty when teaching technology use. Family members struggled to explain simple technology tasks and were frustrated by the slow teaching process.ConclusionsThe results suggest that older adults ask their family members, particularly grandchildren, to support them in the use of new technologies. However, family may experience difficulties in providing this support. Older adults will be increasingly expected to use health technologies, and family members may help with tech support. Providers and health systems should consider potential family support and engagement strategies to foster adoption and use among older patients

Variation in dietary intake and body fatness by socioeconomic status among women in the context of Costa Rican nutrition transitions

The Nutrition Transition model posits that vegetable oils, animal source foods (ASFs) and caloric sweeteners contribute to increases in adiposity and hence body mass index (BMI). Body Mass Index is increasing more rapidly among Latin American populations of low- versus high- socioeconomic status (SES). In Latin America, few studies have evaluated dietary intake and adiposity at the individual level or how they vary by SES. The objectives of this study among Costa Rican women are to: (1) compare indicators of adiposity and dietary intake by SES and (2) evaluate the relationship between intake of foods high in vegetable oils, ASFs or caloric sweeteners and body fatness. This cross-sectional study included 128 low-, middle- and high-SES women. Anthropometry was used to assess BMI, body composition and body fat distribution. Dietary recalls (n=379) were used to assess dietary intake. Body fat percent was greater in low- versus high-SES women (31.5±3.9 vs. 28.2±4.7%). Skinfold measurements at four sites on the upper and lower body were greater in low- versus high-SES women. BMI did not vary in low- versus high-SES women. Intake frequency of foods high in vegetable oils was greater in low- and middle- (1.8 and 1.8 times/day, respectively) versus high- (1.1 times/day) SES women. For individual foods, intake frequency varied significantly by SES for high fat condiments, fried vegetables, dairy, sweetened coffee/tea and pastries and desserts. Intake frequency of Nutrition Transition food categories was not associated with percent body fat after adjustment for energy intake. Indicators of body composition provide additional information beyond BMI that are useful in understanding SES-adiposity associations in Latin America. Approaches to understanding diet and adiposity in Latin America that focus on vegetable oils, ASFs and caloric sweeteners should consider within-country variation in the pace of the Nutrition Transition, especially when explaining variation in adiposity by SES.The Wenner-Gren Foundation/[#8738]//Estados UnidosNational Institutes of Health/[T32 DK007658–27]/NIH/Estados UnidosUCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones en Salud (INISA

Bias in Estimating the Causal Hazard Ratio When Using Two-Stage Instrumental Variable Methods

Two-stage instrumental variable methods are commonly used to estimate the causal effects of treatments on survival in the presence of measured and unmeasured confounding. Two-stage residual inclusion (2SRI) has been the method of choice over two-stage predictor substitution (2SPS) in clinical studies. We directly compare the bias in the causal hazard ratio estimated by these two methods. Under a principal stratification framework, we derive a closed-form solution for asymptotic bias of the causal hazard ratio among compliers for both the 2SPS and 2SRI methods when survival time follows the Weibull distribution with random censoring. When there is no unmeasured confounding and no always takers, our analytic results show that 2SRI is generally asymptotically unbiased, but 2SPS is not. However, when there is substantial unmeasured confounding, 2SPS performs better than 2SRI with respect to bias under certain scenarios. We use extensive simulation studies to confirm the analytic results from our closed-form solutions. We apply these two methods to prostate cancer treatment data from Surveillance, Epidemiology and End Results-Medicare and compare these 2SRI and 2SPS estimates with results from two published randomized trials

Supervision Requirements in the 2020 Hospital Outpatient Prospective Payment System: Implications for Cancer Care in the United States

On November 1, 2019, the Centers for Medicare and Medicaid Services (CMS) released the final 2020 rule for the Hospital Outpatient Prospective Payment System (HOPPS), which updates payment policy for services furnished to Medicare beneficiaries in hospital outpatient departments (HOPD). Although the policy update is often comprised of incremental refinements, this year’s HOPPS update contains a notable change with potentially widespread effects on cancer care delivery in the US: the final rule lowers the minimum level of supervision for hospital outpatient therapeutic services from “direct supervision” to “general supervision.” Here in we review the impetus behind this change and consider its effect on cancer care in regard to access, safety, and scope of practice

Intake of processed meats by Costa Rican women: effect of socioeconomic status

Introducción: El consumo de embutidos se ha asociado con serios problemas de salud que son comunes entre la población femenina. En el 2015 la Agencia Internacional para la Investigación en Cáncer clasificó los embutidos, como carcinógenos para los seres humanos ya que su ingesta está relacionada con el cáncer colorrectal. El aumento en el consumo de embutidos, los cuales son un alimento fuente de proteína de bajo costo, es diferencial según nivel socioeconómico y puede tener un impacto en la incidencia de enfermedades crónicas en la población. Objetivo: examinar la asociación entre el consumo de embutidos y (a) la ingesta total de proteína, (b) la ingesta inadecuada de proteína, según NSE. Métodos: Se seleccionó una muestra (N = 135) de mujeres de 25 a 45 años, con 1 a 4 hijos, pertenecientes a tres diferentes niveles socioeconómicos, residentes de dos cantones del Gran Área Metropolitana de San José, Costa Rica, entre junio 2014 y marzo 2015. Mediante el uso de fotografías se indagó la percepción de las mujeres en cuanto al costo y su preferencia de consumo de 12 distintos alimentos, entre los cuales se incluyó los embutidos. Por medio de recordatorios alimentarios de 24 horas recolectados en tres visitas diferentes, y el uso de la base de datos de composición de alimentos ValorNut, se midió el consumo de proteína total en gramos y se determinó la cantidad promedio de veces por día que las mujeres consumen embutidos. A partir del peso de cada participante se determinó su requerimiento de proteína. La ingesta inadecuada de proteína se estimó como la diferencia entre el requerimiento y la ingesta observada. Mediante un modelo de regresión lineal se determinó la asociación entre el consumo total de proteína medido en gramos y la cantidad de veces por día que se ingiere embutidos. Mediante un modelo de regresión logística se estimó la asociación entre la ingesta inadecuada de proteína y la cantidad de veces por día que se ingiere embutidos. Resultados: Los embutidos son percibidos como la fuente de proteína menos apetecible, sin embargo, fue la tercera fuente de proteína más consumida. El consumo de embutidos difiere según NSE (P < 0.01), en el alto NSE es donde se consumen con menor frecuencia. Los embutidos más comúnmente consumidos fueron mortadela (bajo NSE), salchichón (NSE medio), y jamón de pavo (alto NSE). El consumo de embutidos se asocia significativamente con un incremento en la ingesta de proteína. Se encontró una asociación inversa entre el NSE y la ingesta inadecuada de proteína. Conclusiones: El consumo de embutidos está asociado con el nivel socioeconómico. Es probable que las mujeres consuman embutidos porque los perciben como un alimento fuente de proteína de bajo costo. Se requiere establecer estrategias educativas que ayuden a las mujeres a identificar sus necesidades alimentarias de proteína y a conciliar estas necesidades con la adquisición de alimentos saludables a un costo aceptable.Introduction: Intake of processed meats has been associated with serious health problems that are common among women. In 2015, the International Agency for Research on Cancer classified processed meats as human carcinogens, associated specifically with colon cancer. The increase in intake of processed meats, which are a low-cost source of dietary protein, varies by socioeconomic status (SES) and can impact chronic disease incidence. Objective: Examine the association between processed meats intake and (a) total protein intake, (b) inadequate protein intake, by SES. Methods: This study included a representative sample (N = 135) of women age 25 to 45 years, with one to four children, from three different socioeconomic groups who were residents of two counties from the Greater Metropolitan Area of San José, Costa Rica between June 2014 and March 2015. Using photographs, we examined women’s perceptions of the cost and perceived desirability of 12 different foods, including processed meats. Using 24-hour dietary recalls collected on three different days, and the ValorNut food composition database, we estimated total protein intake, in grams, and determined the intake frequency (times/day) of processed meat. Each women’s dietary protein requirement was estimated based on her bodyweight. Inadequate protein intake was calculated as the difference between protein requirement and actual intake. A linear regression model was used to determine the association between total protein intake in grams and intake frequency (times/day) of processed meat. A logistic regression model was used to estimate the association between low protein intake and intake frequency (times/day) of processed meat. Results: Processed meats were perceived as the least preferred protein source but were the third most commonly consumed protein source. Consumption of processed meats differed by SES and was lower in the higher SES group (P < 0.01). The most commonly consumed processed meats by SES were “mortadella” (low-SES), sausages (middle-SES), and sliced turkey/ham (high-SES). Processed meat intake was significantly associated with an increase in protein intake. There was an inverse association between SES and inadequate protein intake. Conclusions: Processed meat intake is associated with SES. Women may consume processed meats because they are perceived to be a low-cost protein source. Educational strategies are needed to help women identify their protein needs and meet those needs with healthier and affordable dietary alternatives.UCR::Vicerrectoría de Investigación::Unidades de Investigación::Ciencias de la Salud::Instituto de Investigaciones en Salud (INISA)UCR::Vicerrectoría de Docencia::Salud::Facultad de Medicina::Escuela de Nutrició

Palliative care and Parkinson's disease : meeting summary and recommendations for clinical research

Introduction: Palliative care is an approach to caring for patients and families affected by serious illnesses that focuses on the relief of suffering through the management of medical symptoms, psychosocial issues, advance care planning and spiritual wellbeing. Over the past decade there has been an emerging clinical and research interest in the application of palliative care approaches to Parkinson’s disease (PD) and outpatient palliative care services are now offered by several movement disorders centers. Methods: An International Working Group Meeting on PD and Palliative Care supported by the Parkinson’s Disease Foundation was held in October 2015 to review the current state of the evidence and to make recommendations for clinical research and practice. Results: Topics included: 1) Defining palliative care for PD; 2) Lessons from palliative care for heart failure and other chronic illnesses; 3) Patient and caregiver Needs; 4) Needs assessment tools; 5) Intervention strategies; 6) Predicting prognosis and hospice referrals; 7) Choice of appropriate outcome measures; 8) Implementation, dissemination and education research; and 9) Need for research collaborations. We provide an overview of these discussions, summarize current evidence and practices, highlight gaps in our knowledge and make recommendations for future research. Conclusions: Palliative Care for PD is a rapidly growing area which holds great promise for improving outcomes for PD patients and their caregivers. While clinical research in this area can build from lessons learned in other diseases, there is a need for observational, methodological and interventional research to address the unique needs of PD patients and caregivers