Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study
Abstract Background Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the h...
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2018-01-01
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Online Access: | http://link.springer.com/article/10.1186/s12885-017-3926-9 |
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record_format |
Article |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Susana García-Gutierrez Miren Orive Cristina Sarasqueta Maria Jose Legarreta Nerea Gonzalez Maximino Redondo Amado Rivero Pedro Serrano-Aguilar Xavier Castells Jose Maria Quintana Maria Sala on behalf of REDISSEC-CaMISS group |
spellingShingle |
Susana García-Gutierrez Miren Orive Cristina Sarasqueta Maria Jose Legarreta Nerea Gonzalez Maximino Redondo Amado Rivero Pedro Serrano-Aguilar Xavier Castells Jose Maria Quintana Maria Sala on behalf of REDISSEC-CaMISS group Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study BMC Cancer Breast cancer Health services research Clinical prediction rules |
author_facet |
Susana García-Gutierrez Miren Orive Cristina Sarasqueta Maria Jose Legarreta Nerea Gonzalez Maximino Redondo Amado Rivero Pedro Serrano-Aguilar Xavier Castells Jose Maria Quintana Maria Sala on behalf of REDISSEC-CaMISS group |
author_sort |
Susana García-Gutierrez |
title |
Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study |
title_short |
Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study |
title_full |
Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study |
title_fullStr |
Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study |
title_full_unstemmed |
Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective study |
title_sort |
health services research in patients with breast cancer (camiss-prospective): study protocol for an observational prospective study |
publisher |
BMC |
series |
BMC Cancer |
issn |
1471-2407 |
publishDate |
2018-01-01 |
description |
Abstract Background Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Methods Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data collection: Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Statistical analysis: Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. Discussion The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications. Trial registration NCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) . |
topic |
Breast cancer Health services research Clinical prediction rules |
url |
http://link.springer.com/article/10.1186/s12885-017-3926-9 |
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doaj-496909b0a29f423e96ba58ca6d33d39d2020-11-25T00:27:03ZengBMCBMC Cancer1471-24072018-01-0118111010.1186/s12885-017-3926-9Health services research in patients with breast cancer (CAMISS-prospective): study protocol for an observational prospective studySusana García-Gutierrez0Miren Orive1Cristina Sarasqueta2Maria Jose Legarreta3Nerea Gonzalez4Maximino Redondo5Amado Rivero6Pedro Serrano-Aguilar7Xavier Castells8Jose Maria Quintana9Maria Sala10on behalf of REDISSEC-CaMISS groupResearch Unit, Galdakao-Usansolo Hospital [Osakidetza] – Health Services Research on Chronic Patients Network [REDISSEC]Research Unit, Galdakao-Usansolo Hospital [Osakidetza] – Health Services Research on Chronic Patients Network [REDISSEC]Research Unit, Universitario Donostia Hospital – REDISSEC, BioDonostia Health Research InstituteResearch Unit, Galdakao-Usansolo Hospital [Osakidetza] – Health Services Research on Chronic Patients Network [REDISSEC]Research Unit, Galdakao-Usansolo Hospital [Osakidetza] – Health Services Research on Chronic Patients Network [REDISSEC]Department of Biochemistry, Costal del Sol Health AgencyCanary Foundation for Health Care Research (FUNCANIS) – REDISSECEvaluation Unit of the Canary Islands Health Service (SESCS)Department of Epidemiology and Evaluation, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Autonomous University of Barcelona-REDISSECResearch Unit, Galdakao-Usansolo Hospital [Osakidetza] – Health Services Research on Chronic Patients Network [REDISSEC]Department of Epidemiology and Evaluation, Hospital del Mar Medical Research Institute (IMIM), Barcelona, Autonomous University of Barcelona-REDISSECAbstract Background Though breast cancer remains a major health problem, there is a lack of information on health care provided to patients with this disease and associated costs. In addition, there is a need to update and validate risk stratification tools in Spain. Our purpose is to evaluate the health services provided for breast cancer in Spain, from screening and diagnosis to treatment and prognosis. Methods Prospective cohort study involving 13 hospitals in Spain with a follow-up period of up to 5 years after diagnostic biopsy. Eligibility criteria: Patients diagnosed with breast cancer between April 2013 and May 2015 that have consented to participate in the study. Data collection: Data will be collected on the following: pre-intervention medical history, biological, clinical, and sociodemographic characteristics, mode of cancer detection, hospital admission, treatment, and outcomes up to 5 years after initial treatment. Questionnaires about quality of life (EuroQoL EQ-5D-5 L, the European Organization For Research And Treatment Of Cancer Core Quality Of Life Questionnaire EORTC QLQ-C30 join to the specific breast cancer module (QLQ-BR23), as well as Hospital Anxiety and Depression Scale were completed by the patients before the beginning of the initial treatment and at the end of follow-up period, 2 years later. The end-points of the study were changes in health-related quality of life, recurrence, complications and readmissions at 2 and 5 years after initial treatment. Statistical analysis: Descriptive statistics will be calculated and multivariate models will be used where appropriate to adjust for potential confounders. In order to create and validate a prediction model, split validation and bootstrapping will be performed. Cost analysis will be carried out from the perspective of a national health system. Discussion The results of this coordinated project are expected to generate scientifically valid and clinically and socially important information to inform the decision-making of managers and the authorities responsible for ensuring equality in care processes as well in health outcomes. For clinicians, clinical prediction rules will be developed which are expected to serve as the basis for the development of software applications. Trial registration NCT02439554 . Date of registration: May 8, 2015 (retrospectively registered) .http://link.springer.com/article/10.1186/s12885-017-3926-9Breast cancerHealth services researchClinical prediction rules |