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      Feasibility of using Clinical Practice Research Datalink data to identify patients with chronic obstructive pulmonary disease to enrol into real‐world trials

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          Abstract

          Purpose

          To assess the feasibility of using Clinical Practice Research Datalink (CPRD) data for identifying populations of patients with chronic obstructive pulmonary disease (COPD) eligible for a hypothetical pragmatic trial.

          Methods

          A retrospective multidatabase cohort study using CPRD primary care and linked secondary care data to describe the characteristics of populations of patients with COPD. Patients' demographic and lifestyle factors, comorbidity profile, spirometry measurements and treatment changes were evaluated, as was the distribution of follow‐up time and types of losses during follow‐up. Characteristics were evaluated using descriptive statistics.

          Results

          A total of 322 991 patients from 1148 primary care practices in the United Kingdom across two CPRD primary care databases, CPRD GOLD and CPRD Aurum, were potentially eligible to participate in a hypothetical trial using CPRD, starting on 31 December 2017. Patients with COPD in CPRD GOLD and CPRD Aurum were comparable in terms of age (median age 70 vs. 68 years), gender (50% vs. 52% male), disease severity (e.g., 25% vs. 24% Medical Research Council [MRC] dyspnoea score grades 3–5) and history of respiratory conditions (e.g., 43% vs. 38% asthma). High proportions of patients with COPD in CPRD GOLD and CPRD Aurum were available on 31 December 2012 for follow‐up at 1, 2, and 5 years (92%, 85% and 67%, respectively).

          Conclusions

          Patients and data from CPRD GOLD and CPRD Aurum were comparable across key aspects relevant to COPD trials. A pragmatic trial using CPRD to recruit patients with COPD is scientifically feasible.

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          Most cited references18

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          The REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) Statement

          Routinely collected health data, obtained for administrative and clinical purposes without specific a priori research goals, are increasingly used for research. The rapid evolution and availability of these data have revealed issues not addressed by existing reporting guidelines, such as Strengthening the Reporting of Observational Studies in Epidemiology (STROBE). The REporting of studies Conducted using Observational Routinely collected health Data (RECORD) statement was created to fill these gaps. RECORD was created as an extension to the STROBE statement to address reporting items specific to observational studies using routinely collected health data. RECORD consists of a checklist of 13 items related to the title, abstract, introduction, methods, results, and discussion section of articles, and other information required for inclusion in such research reports. This document contains the checklist and explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included herein. This document, as well as the accompanying website and message board (http://www.record-statement.org), will enhance the implementation and understanding of RECORD. Through implementation of RECORD, authors, journals editors, and peer reviewers can encourage transparency of research reporting.
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            Pragmatic Trials.

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              Using real-world data for coverage and payment decisions: the ISPOR Real-World Data Task Force report.

              Health decision-makers involved with coverage and payment policies are increasingly developing policies that seek information on "real-world" (RW) outcomes. Motivated by these initiatives, the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) created a Task Force on Real-World Data to develop a framework to assist health-care decision-makers in dealing with RW data, especially related to coverage and payment decisions. Task Force cochairs were selected by the ISPOR Board of Directors. Cochairs selected chairs for four working groups on: clinical outcomes, economic outcomes, patient-reported outcomes, and evidence hierarchies. Task Force members included representatives from academia, the pharmaceutical industry, and health insurers. The Task Force met on several occasions, conducted frequent correspondence and exchanges of drafts, and solicited comments on three drafts from a core group of external reviewers and from the ISPOR membership. We defined RW data as data used for decision-making that are not collected in conventional randomized controlled trials (RCTs). We considered several characterizations: by type of outcome (clinical, economic, and patient-reported), by hierarchies of evidence (which rank evidence according to the strength of research design), and by type of data source (supplementary data collection alongside RCTs, large simple trials, patient registries, administrative claims database, surveys, and medical records). Our report discusses eight key issues: 1) the importance of RW data; 2) limitations of RW data; 3) the fact that the level of evidence required depends on the circumstance; 4) the need for good research practices for collecting and reporting RW data; 5) the need for good process in using RW data in coverage and reimbursement decisions; 6) the need to consider costs and benefits of data collection; 7) the ongoing need for modeling; and 8) the need for continued stakeholder dialogue on these topics. Real-world data are essential for sound coverage and reimbursement decisions. The types and applications of such data are varied, and context matters greatly in determining the value of a particular type in any circumstance. It is critical that policymakers recognize the benefits, limitations, and methodological challenges in using RW data, and the need to consider carefully the costs and benefits of different forms of data collection in different situations.
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                Author and article information

                Contributors
                gema.x.requena@gsk.com
                Journal
                Pharmacoepidemiol Drug Saf
                Pharmacoepidemiol Drug Saf
                10.1002/(ISSN)1099-1557
                PDS
                Pharmacoepidemiology and Drug Safety
                John Wiley & Sons, Inc. (Chichester, UK )
                1053-8569
                1099-1557
                09 January 2021
                April 2021
                : 30
                : 4 ( doiID: 10.1002/pds.v30.4 )
                : 472-481
                Affiliations
                [ 1 ] Respiratory Epidemiology GlaxoSmithKline Brentford UK
                [ 2 ] Clinical Practice Research Datalink Medicines and Healthcare Products Regulatory Agency London UK
                [ 3 ] Respiratory Epidemiology, Occupational Medicine and Public Health National Heart and Lung Institute, Imperial College London London UK
                Author notes
                [*] [* ] Correspondence

                Gema Requena, Epidemiology, Value Evidence and Outcomes, Global Medical GSK, 980 Great West Road, Brentford, Middlesex TW8 9GS, UK.

                Email: gema.x.requena@ 123456gsk.com

                [†]

                Affiliation at time of study.

                Author information
                https://orcid.org/0000-0002-1889-6656
                https://orcid.org/0000-0001-9007-6292
                Article
                PDS5188
                10.1002/pds.5188
                7986187
                33368820
                d2cd2e5b-b33f-4446-aa10-b4e6d3daf32b
                © 2020 GSK. Pharmacoepidemiology and Drug Safety published by John Wiley & Sons Ltd.

                This is an open access article under the terms of the http://creativecommons.org/licenses/by/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited.

                History
                : 24 June 2020
                : 22 December 2020
                Page count
                Figures: 1, Tables: 4, Pages: 10, Words: 6792
                Funding
                Funded by: GlaxoSmithKline plc. , open-funder-registry 10.13039/100004330;
                Award ID: study 206406/HO‐15‐16210
                Categories
                Original Article
                Original Articles
                Custom metadata
                2.0
                April 2021
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.0.0 mode:remove_FC converted:23.03.2021

                Pharmacology & Pharmaceutical medicine
                chronic obstructive pulmonary disease,electronic health record,feasibility studies,general practice,primary health care,real world clinical trials

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