Colorectal cancer health services research study protocol: the CCR-CARESS observational prospective cohort project

The REDISSEC CARESS-CCR (Results and Health Services Research in Colorectal Cancer)- group: Jose María Quintana, Marisa Baré, Maximino Redondo, Eduardo Briones, Nerea Fernández de Larrea, Cristina Sarasqueta, Antonio Escobar, Francisco Rivas, Maria M. Morales-Suárez, Juan Antonio Blasco, Isabel del Cura, Inmaculada Arostegui, Amaia Bilbao, Nerea González, Susana García-Gutiérrez, Iratxe Lafuente, Urko Aguirre, Miren Orive, Josune Martin, Ane Antón-Ladislao, Núria Torà, Marina Pont, María Purificación Martínez del Prado, Alberto Loizate, Ignacio Zabalza, José Errasti, Antonio Z Gimeno, Santiago Lázaro, Mercè Comas, Jose María Enríquez, Carlos Placer, Amaia Perales, Iñaki Urkidi, Jose María Erro, Enrique Cormenzana, Adelaida Lacasta, Pep Piera Pibernat, Elena Campano, Ana Isabel Sotelo, Segundo Gómez-Abril, F. Medina-Cano, Julia Alcaide, Arturo Del Rey-Moreno, Manuel Jesús Alcántara, Rafael Campo, Alex Casalots, Carles Pericay, Maria José Gil, Miquel Pera, Pablo Collera, Josep Alfons Espinàs, Mercedes Martínez, Mireia Espallargues, Caridad Almazán, Paula Dujovne Lindenbaum, José María Fernández-Cebrián, Rocío Anula Fernández, Julio Ángel Mayol, Ramón Cantero, Héctor Guadalajara, María Heras, Damián García, Mariel Morey, Javier Mar.[Background] Colorectal cancers are one of the most common forms of malignancy worldwide. But two significant areas of research less studied deserve attention: health services use and development of patient stratification risk tools for these patients.[Methods] Design: a prospective multicenter cohort study with a follow up period of up to 5 years after surgical intervention. Participant centers: 22 hospitals representing six autonomous communities of Spain. Participants/Study population: Patients diagnosed with colorectal cancer that have undergone surgical intervention and have consented to participate in the study between June 2010 and December 2012. Variables collected include pre-intervention background, sociodemographic parameters, hospital admission records, biological and clinical parameters, treatment information, and outcomes up to 5 years after surgical intervention. Patients completed the following questionnaires prior to surgery and in the follow up period: EuroQol-5D, EORTC QLQ-C30 (The European Organization for Research and Treatment of Cancer quality of life questionnaire) and QLQ-CR29 (module for colorectal cancer), the Duke Functional Social Support Questionnaire, the Hospital Anxiety and Depression Scale, and the Barthel Index. The main endpoints of the study are mortality, tumor recurrence, major complications, readmissions, and changes in health-related quality of life at 30 days and at 1, 2, 3 and 5 years after surgical intervention. Statistical analysis: In relation to the different endpoints, predictive models will be used by means of multivariate logistic models, Cox or linear mixed-effects regression models. Simulation models for the prediction of discrete events in the long term will also be used, and an economic evaluation of different treatment strategies will be performed through the use of generalized linear models.[Discussion] The identification of potential risk factors for adverse events may help clinicians in the clinical decision making process. Also, the follow up by 5 years of this large cohort of patients may provide useful information to answer different health services research questions.[Trial registration] ClinicalTrials.gov Identifier: NCT02488161. Registration date: June 16, 2015.This work was supported in part by grants from the Fondo de Investigación Sanitaria (PS09/00314, PS09/00910, PS09/00746, PS09/00805, PI09/90460, PI09/90490, PI09/90397, PI09/90453, PI09/90441); Department of Health of the Basque Country (2010111098); KRONIKGUNE –Centro de Investigación en Cronicidad (KRONIK 11/006); and the European Regional Development Fund (ERDF).Peer reviewe