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      Cohort profile: the Martinique Cancer Registry and the quality of life prostate cancer cohort (QoL Prostate-MQ): challenges and prospects for reducing disparities in the Caribbean

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          Abstract

          Purpose

          Recording cancer data in cancer registries is essential for producing reliable population-based data for service planning, monitoring and evaluation. Prostate cancer (PCa) remains the most frequent type of cancer in terms of incidence and mortality in men in the Caribbean. The quality of life PCa cohort will assess quality of life and patient outcomes in Martinique using a digital platform for patient-reported outcome measures.

          Participants

          The Martinique Cancer Registry database is the largest clinical database among the French population-based cancer registries in the Caribbean, including more than 38 000 cancer cases, with 1650 new cancer cases per year, including 550 new PCa cases per year (2010–2014 latest period). In 2018, follow-up will include vital status, assessment of quality of life with the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire (QLQ) Core 30 and the Prostate cancer module QLQ-PR25. Urinary incontinence and erectile dysfunction recorded prior to treatment will be analysed 1 and 5 years after treatment.

          Findings to date

          The registry includes data on circumstances of diagnosis, clinical stage at diagnosis. For PCa, the registry includes blood prostate-specific antigen level at the time of diagnosis, Gleason score and primary treatment.

          Future plans

          Further studies will provide detailed data regarding the quality of diagnosis and management of patients with PCa in Martinique; analysing quality of care will be the next challenge.

          Quality of life and patient outcomes will be evaluated using a digital platform for patient-reported outcome measurement and electronic records.

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          Most cited references25

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          Linking clinical variables with health-related quality of life. A conceptual model of patient outcomes.

          Our model proposes a taxonomy or classification scheme for different measures of health outcome. We divide these outcomes into five levels: biological and physiological factors, symptoms, functioning, general health perceptions, and overall quality of life. In addition to classifying these outcome measures, we propose specific causal relationships between them that link traditional clinical variables to measures of HRQL. As one moves from left to right in the model, one moves outward from the cell to the individual to the interaction of the individual as a member of society. The concepts at each level are increasingly integrated and increasingly difficult to define and measure. AT each level, there are an increasing number of inputs that cannot be controlled by clinicians or the health care system as it is traditionally defined.
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            Quality of life research within the EORTC-the EORTC QLQ-C30. European Organisation for Research and Treatment of Cancer.

            In forming its Quality of Life Group, the EORTC created one of the earliest and largest of such groups in Europe. The EORTC QLQ-C30 which this group developed has become the most widely used questionnaire in Europe for cancer patients, and is extensively used around the world. The Quality of Life Group continues to build upon this success, both by refining the QLQ-C30, whilst developing a range of additional modules, and by initiating research projects that explore aspects of quality of life assessment, evaluation and interpretation. We review the progress to date and indicate directions of further research and development.
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              Recommendations on health-related quality of life research to support labeling and promotional claims in the United States.

              Health-related quality of life (HRQL) outcomes evaluation is becoming an important component of clinical trials of new pharmaceuticals and medical devices. HRQL research provides patients, providers, and decision makers with important information on the impact of disease and treatment on physical, psychological, and social functioning and well-being. These outcomes are also useful to the pharmaceutical and device industries as they attempt to understand and communicate product value to physicians, patients, health insurers and others. HRQL labeling and promotional claims in the US are likely to increase over the next few years. The evidentiary requirements to make such a claim should be based on accepted scientific standards of HRQL evaluation and consistent with the regulatory requirements for clinical efficacy. This report outlines the scientific practices that should be considered in the evaluation of evidence for an HRQL claim, including the selection of appropriate domains, evidence to support the reliability and validity of HRQL measurement, considerations in research design and statistical analyses, and the issue of clinical significance. Representatives from the pharmaceutical and device industries, regulatory agencies, and the HRQL scientific community should work together to make certain the use of HRQL in labeling and promotion are based on sound scientific evidence, and that these messages are clearly and accurately reported to the consumers.
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                Author and article information

                Journal
                BMJ Open
                BMJ Open
                bmjopen
                bmjopen
                BMJ Open
                BMJ Publishing Group (BMA House, Tavistock Square, London, WC1H 9JR )
                2044-6055
                2018
                25 July 2018
                : 8
                : 7
                : e021540
                Affiliations
                [1 ] departmentUF1441 Registre des cancers de la Martinique, Pôle de Cancérologie Hématologie Urologie Pathologie , CHU Martinique , Fort-de-France, Martinique
                [2 ] departmentGroupe d’Étude, de Formation et de Recherche en Andrologie , Urologie et Sexologie Médecine de la Reproduction , Toulouse, France
                [3 ] departmentGroupe de recherche en fertilité humaine , CHU Toulouse Paule de Viguier , Toulouse, France
                [4 ] departmentPôle de Cancérologie Hématologie Urologie Pathologie , CHU Martinique , Fort-de-France, Martinique
                [5 ] departmentPôle de Gériatrie , CHU de Martinique , Fort-de-France, Martinique
                [6 ] departmentUnité d’aide Méthodologique, Pôle Recherche et Santé publique , CHU de Reims , Reims, France
                [7 ] departmentEA 3797, Université de Reims Champagne-Ardenne , Faculté de Médecine , Reims, France
                [8 ] departmentDépartement de Médecine Interne et Gériatrie , CHU de Reims , Reims, France
                [9 ] departmentService de Médecine nucléaire, Pole d’imagerie Médicale , CHU Martinique , Fort-de-France, Martinique
                Author notes
                [Correspondence to ] Dr Clarisse Joachim; clarisse.joachim@ 123456hotmail.fr
                Author information
                http://orcid.org/0000-0002-2967-7205
                http://orcid.org/0000-0003-4911-2217
                Article
                bmjopen-2018-021540
                10.1136/bmjopen-2018-021540
                6067331
                30049695
                07ee4e72-2800-49be-8382-89d18eac6d44
                © Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

                This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

                History
                : 13 January 2018
                : 01 June 2018
                : 15 June 2018
                Funding
                Funded by: The Martinique Cancer Registry;
                Categories
                Epidemiology
                Cohort Profile
                1506
                1692
                Custom metadata
                unlocked

                Medicine
                prostate cancer,quality of life,cancer registry
                Medicine
                prostate cancer, quality of life, cancer registry

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