Implementation of a methodology to assess patient reported outcomes in lung cancer patients: The PeOpLe (Patient-reported Outcomes in Lung cancer ) study protocol.

OBJECTIVE: The purpose of this article is to describe the PeOpLe study protocol, developed to assess patient-reported health outcomes in  advanced or metastatic non-small-cell lung cancer in routine clinical practice using the methodology provided by the International Consortium for Health Outcomes Measurement tool. METHOD: The study envisaged will be multicenter, longitudinal, ambispective and observational. Two groups will be compared: a control group (followed up according to standard clinical practice) and an experimental group (followed up using the International Consortium for Health  Outcomes Measurement methodology adapted to the Spanish setting for 6  months). The variables collected will be related to demography (age, sex,  degree of family support), clinical factors (smoking, comorbidities, lung  capacity), the neoplasm (histology, staging, mutations), pharmacotherapy  (treatment schedule, modifications, and complications), health status  (functional status, quality of life, satisfaction and overall survival) and resource consumption (emergency visits, hospital admissions and time spent by health providers). The PeOpLe study protocol has been approved by the Ethics Committee for Research into Medicinal Products of the Gregorio Marañón General University Hospital and will be conducted in compliance with prevailing ethical principles and standards. CONCLUSIONS: The PeOpLe study will explore how patient-reported outcomes collection can be developed and integrated with the clinical processes used in  the management of patients with locally advanced or metastatic nonsmall cell  lung cancer what patient-reported outcomes can be measured with systems  that can conveniently be used both by patients and by healthcare providers.  Systematic evaluation of patient-reported outcomes will help determine their  impact in terms of effectiveness (survival), safety (complications of systemic  therapy), and quality of life and patient satisfaction. The multidisciplinary and  multicenter nature of the study will facilitate a comprehensive view of the  subject analyzed and allow external reproducibility.

OBJETIVO: El objetivo es describir el protocolo del estudio PeOpLe, cuyo fin es  evaluar los resultados en salud centrados en el paciente con cáncer de pulmón  no microcítico avanzado o metastásico en la práctica clínica habitual mediante  una metodología adaptada de la herramienta del International Consortium for  Health Outcomes Measurement.Método: Estudio observacional, ambispectivo, longitudinal y multicéntrico. Se  compararán dos grupos: grupo control (seguimiento según práctica clínica  habitual) frente a un grupo intervención (seguimiento mediante la metodología  del International Consortium for Health Outcomes Measurement adaptada al entorno español) durante un período de 6 meses.  Las variables recogidas incluirán aspectos demográficos (edad, sexo, apoyo familiar), clínicos (hábito tabáquico, comorbilidades, capacidad   pulmonar), del tumor (histología, estadiaje, mutaciones), farmacoterapéutico (esquema de tratamiento, modificaciones y  complicaciones), grado de salud (estado funcional, calidad de vida, satisfacción y supervivencia global) y consumo de recursos (visitas a urgencias, ingresos  hospitalarios y tiempo dedicado por los profesionales sanitarios). El protocolo  del estudio PeOpLe ha sido aprobado por el Comité de Ética de la Investigación con medicamentos y se realizará respetando los principios y las normas éticas  básicas. CONCLUSIONES: El estudio PeOpLe explorará cómo se pueden desarrollar e  integrar los procesos de medición de resultados en salud centrados en los  pacientes, especialmente los patient-reported outcomes, en pacientes con  cáncer de pulmón no microcítico localmente avanzado o metastásico en la  práctica clínica. La evaluación sistemática de estos patient-reported outcomes  permitirá conocer su impacto en términos de efectividad (supervivencia),  seguridad (complicaciones de la terapia sistémica) y calidad de vida y  satisfacción. El carácter multidisciplinar y multicéntrico facilitará una visión  integral y su reproducibilidad externa.

Implantación de una metodología para evaluarpatient-reported outcomes en pacientes con cáncer de pulmón: Protocolo del estudio PeOpLe(Patient-reported Outcomes in Lung cancer) / Implementation of a methodology to assess patient reported outcomes in lung cancer patients: The PeOpLe (Patient-reported Outcomes in Lung cancer) study protocol

Objetivo: El objetivo es describir el protocolo del estudio PeOpLe, cuyofin es evaluar los resultados en salud centrados en el paciente con cáncerde pulmón no microcítico avanzado o metastásico en la práctica clínicahabitual mediante una metodología adaptada de la herramienta del International Consortium for Health Outcomes Measurement.Método: Estudio observacional, ambispectivo, longitudinal y multicéntrico. Se compararán dos grupos: grupo control (seguimiento según práctica clínica habitual) frente a un grupo intervención (seguimiento mediantela metodología del International Consortium for Health Outcomes Measurement adaptada al entorno español) durante un período de 6 meses. Lasvariables recogidas incluirán aspectos demográficos (edad, sexo, apoyofamiliar), clínicos (hábito tabáquico, comorbilidades, capacidad pulmonar), del tumor (histología, estadiaje, mutaciones), farmacoterapéutico(esquema de tratamiento, modificaciones y complicaciones), grado desalud (estado funcional, calidad de vida, satisfacción y supervivencia global) y consumo de recursos (visitas a urgencias, ingresos hospitalariosy tiempo dedicado por los profesionales sanitarios). El protocolo del estudio PeOpLe ha sido aprobado por el Comité de Ética de la Investigacióncon medicamentos y se realizará respetando los principios y las normaséticas básicas. (AU)

Objective: The purpose of this article is to describe the PeOpLe studyprotocol, developed to assess patient-reported health outcomes in advanced or metastatic non-small-cell lung cancer in routine clinical practiceusing the methodology provided by the International Consortium forHealth Outcomes Measurement tool.Method: The study envisaged will be multicenter, longitudinal, ambispective and observational. Two groups will be compared: a control group(followed up according to standard clinical practice) and an experimentalgroup (followed up using the International Consortium for Health OutcomesMeasurement methodology adapted to the Spanish setting for 6 months).The variables collected will be related to demography (age, sex, degreeof family support), clinical factors (smoking, comorbidities, lung capacity),the neoplasm (histology, staging, mutations), pharmacotherapy (treatmentschedule, modifications, and complications), health status (functionalstatus, quality of life, satisfaction and overall survival) and resource consumption (emergency visits, hospital admissions and time spent by healthproviders). The PeOpLe study protocol has been approved by the EthicsCommittee for Research into Medicinal Products of the Gregorio MarañónGeneral University Hospital and will be conducted in compliance withprevailing ethical principles and standards. (AU)

Defining a Standard Set of Patient-Reported Outcomes for Patients With Advanced Ovarian Cancer.

Purpose: Advanced ovarian cancer (AOC) and its treatment cause several symptoms and impact on patients' health-related quality of life (HRQoL). We aim to reach a consensus on the most relevant patient-reported outcome (PROs), the corresponding measures (PROMs), and measurement frequency during AOC patients' follow-up from patients' and healthcare professionals' (HCP) perspective. Methods: The project comprised five steps: 1) a literature review, 2) a focus group with patients, 3) a nominal group with HCP, 4) two round-Delphi consultations with patients and HCP, and 5) a final meeting with HCP. Delphi questionnaire was elaborated based on literature review, focus group (n=5 patients), and nominal group (n=16 HCP). The relevance of each PRO and the appropriateness (A) and feasibility (F) of the proposed PROM were assessed (Likert scale 1=strongly agree; 9=strongly disagree). The consensus was reached when at least 75% of the panelists rated it as 'relevant', 'appropriate', or 'feasible' (score 7-9). Results: A total of 56 HCP [51.8% Hospital Pharmacy; 41.1% Oncology; 3.6% Nursing; and 3.6% Psycho-oncology; mean time in specialty 12.5 (8.0) years] and 10 AOC patients [mean time diagnosis 5.4 (3.0) years] participated in the 1st round. All PROs achieved consensus regarding their relevance, except dry skin (58.0%). Agreement was reached for PRO-CTCAE to be used to assess fatigue (A:84.9%; F:75.8%), neuropathy (A:92.4%; F:77.3%), diarrhea (A:87.9%; F:88.7%), constipation (A:86.4%; F:75.8%), nausea (A:89.4%; F:75.8%), insomnia (A:81.8%; F:88.7%), abdominal bloating (A:82.2%; F:82.2%) and sexuality (A:78.8%; F:88.6%); EQ-5D to determine patients' HRQoL (A:87.9%; F:80.3%), pain (A:87.9%; F:75.8%) and mood (A:77.7%; F:85.5%); to assess treatment adherence the Morisky-Green (A:90.9%; F:84.9%) and the dispensing register (A:80.3%; F:80.3%) were chosen. It was agreed to note in the medical record whether the patient's treatment preferences had been considered during decision-making (A:78.8%; F:78.8%) and to use a 5-point Likert scale to assess treatment satisfaction (A:86.4%; F:86.4%). Panelists agreed (A:92.4%; F: 77.3%) to collect these PROs (1) at the time of diagnosis/relapse; (2) one month after starting treatment/change therapeutic strategy; (3) every three months during the 1st-year of treatment; and later (4) every six months until treatment completion/change. Conclusions: The consensus reached represents the first step towards including the patient's perspective in AOC follow-up. The standardized collection of PROs in clinical practice may contribute to optimizing the follow-up of these patients and thus improving the quality of care.