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Integrating 4 methods to evaluate physical function in patients with cancer (In4M): protocol for a prospective cohort study

Por: Thanarajasingam · G. · Kluetz · P. · Bhatnagar · V. · Brown · A. · Cathcart-Rake · E. · Diamond · M. · Faust · L. · Fiero · M. H. · Huntington · S. · Jeffery · M. M. · Jones · L. · Noble · B. · Paludo · J. · Powers · B. · Ross · J. S. · Ritchie · J. D. · Ruddy · K. · Schellhorn · S. · Tarv
Introduction

Accurate, patient-centred evaluation of physical function in patients with cancer can provide important information on the functional impacts experienced by patients both from the disease and its treatment. Increasingly, digital health technology is facilitating and providing new ways to measure symptoms and function. There is a need to characterise the longitudinal measurement characteristics of physical function assessments, including clinician-reported outcome, patient-reported ported outcome (PRO), performance outcome tests and wearable data, to inform regulatory and clinical decision-making in cancer clinical trials and oncology practice.

Methods and analysis

In this prospective study, we are enrolling 200 English-speaking and/or Spanish-speaking patients with breast cancer or lymphoma seen at Mayo Clinic or Yale University who will receive intravenous cytotoxic chemotherapy. Physical function assessments will be obtained longitudinally using multiple assessment modalities. Participants will be followed for 9 months using a patient-centred health data aggregating platform that consolidates study questionnaires, electronic health record data, and activity and sleep data from a wearable sensor. Data analysis will focus on understanding variability, sensitivity and meaningful changes across the included physical function assessments and evaluating their relationship to key clinical outcomes. Additionally, the feasibility of multimodal physical function data collection in real-world patients with breast cancer or lymphoma will be assessed, as will patient impressions of the usability and acceptability of the wearable sensor, data aggregation platform and PROs.

Ethics and dissemination

This study has received approval from IRBs at Mayo Clinic, Yale University and the US Food and Drug Administration. Results will be made available to participants, funders, the research community and the public.

Trial registration number

NCT05214144; Pre-results.

Deficiencies in reporting inclusion/exclusion criteria and characteristics of patients in randomized controlled trials of therapeutic interventions in pressure injuries: a systematic methodological review

Abstract

Wound care is a complex procedure and the related research may include many variables. Deficiencies in the sample inclusion and exclusion criteria may limit the generalizability of randomized controlled trials (RCTs) for wound patients in the real world. This study aimed to evaluate deficiencies in reporting the inclusion and exclusion criteria and the characteristics of patients in RCTs of pressure injuries (PI) therapeutic interventions. We conducted a systematic methodological review in which 40 full text RCTs of PI treatment interventions published in English, from 2008 to 2020, were identified. Data on the general characteristics of the included RCTs and data about inclusion/exclusion criteria and characteristics of patients were collected. The inclusion/exclusion criteria were categorized into five domains (definition of disease, precision, safety, ethical/legal and administrative). Study duration (in weeks) was 8.0 (quartile 1: 2.0; quartile 3: 48.0); only 5.0% of the trials mentioned race, skin colour or ethnicity, and 37.5% reported the duration of the wound. Only 9 (22.5%) studies reported the drugs that the included patients were using and 10 (25.0%) RCTs reported adverse events. The presence of the five domains was observed only in 12.5% of RCTs and only 12 (30.0%) had the precision domain. Much more research is required in systematic assessments of the external validity of trials because there is substantial disparity between the information that is provided by RCTs and the information that is required by clinicians. We concluded that there are deficiencies in reporting of data related to inclusion/exclusion criteria and characteristics of patients of RCTs assessing PI therapeutic interventions.

Enfermedad renal crónica como causa de disfunción familiar: análisis fenomenológico desde una perspectiva holística

Objetivo principal: Evaluar la disfunción familiar desde una perspectiva holística en enfermos renales en terapia sustitutiva en un hospital de Monterrey, México. Metodología: Diseño mixto, analítico, transversal. Población conformada por 634 enfermos renales en terapias de sustitución de un hospital de segundo nivel en Monterrey. Se usó estadística descriptiva e inferencial para datos cuantitativos. Para la parte cualitativa se usó metodología fenomenológica conforme a la teoría fundamentada y análisis de dominios. Resultados principales: Alta prevalencia de disfuncionalidad familiar (70%). Según los enfermos renales en etapas avanzadas, el abandono por parte del cónyuge, la infidelidad marital, la exclusión familiar y los problemas económicos, son los principales factores que fracturan los lazos y la estruc-tura familiar. Conclusión principal: La enfermedad renal puede ser factor de disfuncionalidad familiar, hecho que compromete las relacio-nes entre los miembros familiares y afecta el apego a los tratamientos sustitutivos, al ser estos dependientes de un cuidador primario.

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