The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE).
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SUBMITTER: Langan SM
PROVIDER: S-EPMC6234471 | biostudies-literature | 2018 Nov
REPOSITORIES: biostudies-literature
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The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology (RECORD-PE).
Langan Sinéad M SM Schmidt Sigrún Aj SA Wing Kevin K Ehrenstein Vera V Nicholls Stuart G SG Filion Kristian B KB Klungel Olaf O Petersen Irene I Sorensen Henrik T HT Dixon William G WG Guttmann Astrid A Harron Katie K Hemkens Lars G LG Moher David D Schneeweiss Sebastian S Smeeth Liam L Sturkenboom Miriam M von Elm Erik E Wang Shirley V SV Benchimol Eric I EI
BMJ (Clinical research ed.) 20181114
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Project description: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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Project description: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 as well as explanatory and elaboration information to enhance the use of the checklist. Examples of good reporting for each RECORD checklist item are also included. This document, as well as the accompanying website and message board (http://www.record-statement.org), will improve the implementation and understanding of RECORD. By implementing RECORD, authors, journals editors, and peer reviewers can enhance transparency of research reporting.
| S-EPMC5330542 | biostudies-literature
Project description:ObjectiveRoutinely collected health data, collected for administrative and clinical purposes, without specific a priori research questions, are increasingly used for observational, comparative effectiveness, health services research, and clinical trials. The rapid evolution and availability of routinely collected data for research has brought to light specific issues not addressed by existing reporting guidelines. The aim of the present project was to determine the priorities of stakeholders in order to guide the development of the REporting of studies Conducted using Observational Routinely-collected health Data (RECORD) statement.MethodsTwo modified electronic Delphi surveys were sent to stakeholders. The first determined themes deemed important to include in the RECORD statement, and was analyzed using qualitative methods. The second determined quantitative prioritization of the themes based on categorization of manuscript headings. The surveys were followed by a meeting of RECORD working committee, and re-engagement with stakeholders via an online commentary period.ResultsThe qualitative survey (76 responses of 123 surveys sent) generated 10 overarching themes and 13 themes derived from existing STROBE categories. Highest-rated overall items for inclusion were: Disease/exposure identification algorithms; Characteristics of the population included in databases; and Characteristics of the data. In the quantitative survey (71 responses of 135 sent), the importance assigned to each of the compiled themes varied depending on the manuscript section to which they were assigned. Following the working committee meeting, online ranking by stakeholders provided feedback and resulted in revision of the final checklist.ConclusionsThe RECORD statement incorporated the suggestions provided by a large, diverse group of stakeholders to create a reporting checklist specific to observational research using routinely collected health data. Our findings point to unique aspects of studies conducted with routinely collected health data and the perceived need for better reporting of methodological issues.
| S-EPMC4428635 | biostudies-literature
Project description:ObjectivesTo assess reporting quality of studies using routinely collected health data (RCD) to inform the REporting of studies Conducted using Observational Routinely collected health Data (RECORD) guideline development.Study design and settingPubMed search for observational studies using RCD on any epidemiologic or clinical topic. Sample of studies published in 2012. Evaluation of five items based on the STrengthening the Reporting of OBservational studies in Epidemiology (STROBE) guideline and eight newly developed items for RCD studies.ResultsOf 124 included studies, 39 (31.5%) clearly described its design in title or abstract. Complete information to frame a focused research question, that is, on the population, intervention/exposure, and outcome, was provided for 51 studies (41.1%). In 44 studies where definitions of codes or classification algorithms would be necessary to operationalize such a research question, only nine (20.5%) reported all items adequately. In 81 studies describing multivariable analyses, 54 (66.7%) reported all variables used for modeling and 34 (42.0%) reported basic details required for replication. Database linkage was reported adequately in 12 of 41 studies (29.3%). Statements about data sharing/availability were rare (5/124; 4%).ConclusionMost RCD studies are insufficiently reported. Specific reporting guidelines and more awareness and education on their use are urgently needed.
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Project description:ObjectiveTo describe characteristics of randomized controlled trials (RCTs) conducted using electronic health records (EHRs), including completeness and transparency of reporting assessed against the 2021 CONSORT Extension for RCTs Conducted Using Cohorts and Routinely Collected Data (CONSORT-ROUTINE) criteria.Study designMEDLINE and Cochrane Methodology Register were searched for a sample of RCTs published from 2011-2018. Completeness of reporting was assessed in a random sample using a pre-defined coding form.ResultsOf the 183 RCT publications identified, 122 (67%) used EHRs to identify eligible participants, 139 (76%) used the EHR as part of the intervention and 137 (75%) to ascertain outcomes. When 60 publications were evaluated against the CONSORT 2010 item and the corresponding extension for the 8 modified items, four items were 'adequately reported' for most trials. Five new reporting items were identified for the CONSORT-ROUTINE extension; when evaluated, one was 'adequately reported', three were reported 'inadequately or not at all', the other 'partially'. There were, however, some encouraging signs with adequate and partial reporting of many important items, including descriptions of trial design, the consent process, outcome ascertainment and interpretation.ConclusionAspects of RCTs using EHRs are sub-optimally reported. Uptake of the CONSORT-ROUTINE Extension may improve reporting.
| S-EPMC8982641 | biostudies-literature
Project description:ObjectivesRandomised controlled trials conducted using cohorts and routinely collected data, including registries, electronic health records and administrative databases, are increasingly used in healthcare intervention research. A Consolidated Standards of Reporting Trials (CONSORT) statement extension for trials conducted using cohorts and routinely collected data (CONSORT-ROUTINE) has been developed with the goal of improving reporting quality. This article describes the processes and methods used to develop the extension and decisions made to arrive at the final checklist.MethodsThe development process involved five stages: (1) identification of the need for a reporting guideline and project launch; (2) conduct of a scoping review to identify possible modifications to CONSORT 2010 checklist items and possible new extension items; (3) a three-round modified Delphi study involving key stakeholders to gather feedback on the checklist; (4) a consensus meeting to finalise items to be included in the extension, followed by stakeholder piloting of the checklist; and (5) publication, dissemination and implementation of the final checklist.Results27 items were initially developed and rated in Delphi round 1, 13 items were rated in round 2 and 11 items were rated in round 3. Response rates for the Delphi study were 92 of 125 (74%) invited participants in round 1, 77 of 92 (84%) round 1 completers in round 2 and 62 of 77 (81%) round 2 completers in round 3. Twenty-seven members of the project team representing a variety of stakeholder groups attended the in-person consensus meeting. The final checklist includes five new items and eight modified items. The extension Explanation & Elaboration document further clarifies aspects that are important to report.ConclusionUptake of CONSORT-ROUTINE and accompanying Explanation & Elaboration document will improve conduct of trials, as well as the transparency and completeness of reporting of trials conducted using cohorts and routinely collected data.
| S-EPMC8094349 | biostudies-literature
Project description: Not available
| S-EPMC8082311 | biostudies-literature
Project description:ObjectivesRespondent-driven sampling (RDS) is a new data collection methodology used to estimate characteristics of hard-to-reach groups, such as the HIV prevalence in drug users. Many national public health systems and international organizations rely on RDS data. However, RDS reporting quality and available reporting guidelines are inadequate. We carried out a systematic review of RDS studies and present Strengthening the Reporting of Observational Studies in Epidemiology for RDS Studies (STROBE-RDS), a checklist of essential items to present in RDS publications, justified by an explanation and elaboration document.Study design and settingWe searched the MEDLINE (1970-2013), EMBASE (1974-2013), and Global Health (1910-2013) databases to assess the number and geographical distribution of published RDS studies. STROBE-RDS was developed based on STROBE guidelines, following Guidance for Developers of Health Research Reporting Guidelines.ResultsRDS has been used in over 460 studies from 69 countries, including the USA (151 studies), China (70), and India (32). STROBE-RDS includes modifications to 12 of the 22 items on the STROBE checklist. The two key areas that required modification concerned the selection of participants and statistical analysis of the sample.ConclusionSTROBE-RDS seeks to enhance the transparency and utility of research using RDS. If widely adopted, STROBE-RDS should improve global infectious diseases public health decision making.
| S-EPMC4669303 | biostudies-literature
Project description:Routinely collected health data (RCD) are important resource for exploring drug treatment effects. Adequate reporting of data source profiles may increase the credibility of evidence generated from these data. This study conducted a systematic literature review to evaluate the reporting characteristics of databases used by RCD studies to explore the effects of drug treatment. Observational studies published in 2018 that used RCD to explore the effects of drug treatment were identified by searching PubMed. We categorized eligible reports into two groups by journal impact factor (IF), including the top 5 general medical journals (NEJM, Lancet, JAMA, BMJ and JAMA Internal Medicine) and the other journals. The reporting characteristics of the databases used were described and compared between the two groups and between studies citing and not citing database references. A total of 222 studies were included, of which 53 (23.9%) reported that they applied data linkage, 202 (91.0%) reported the type of database, and 211 (95.0%) reported the coverage of the data source. Only 81 (36.5%) studies reported the timeframe of the database. Studies in high-impact journals were more likely to report that they applied data linkage (65.1% vs. 20.2%) and used electronic medical records (EMR) (73.7% vs. 30.0%) and national data sources (77.8% vs. 51.3%) than those published in other medical journals. There were 137/222 (61.7%) cited database references. Studies with database-specific citations had better reporting of the data sources and were more likely to publish in high-impact journals than those without (mean IF, 6.08 vs. 4.09). Some deficits were found in the reporting quality of databases in studies that used RCD to explore the effects of drug treatment. Studies citing database-specific references may provide detailed information regarding data source characteristics. The adoption of reporting guidelines and education on their use is urgently needed to promote transparency by research groups.
| S-EPMC10120171 | biostudies-literature
Project description:BackgroundIn recent years, studies that used routinely collected data (RCD), such as electronic medical records and administrative claims, for exploring drug treatment effects, including effectiveness and safety, have been increasingly published. Abstracts of such studies represent a highly attended source for busy clinicians or policy-makers, and are important for indexing by literature database. If less clearly presented, they may mislead decisions or indexing. We thus conducted a cross-sectional survey to systematically examine how the abstracts of such studies were reported.MethodsWe searched PubMed to identify all observational studies published in 2018 that used RCD for assessing drug treatment effects. Teams of methods-trained collected data from eligible studies using pilot-tested, standardized forms that were developed and expanded from "The reporting of studies conducted using observational routinely collected health data statement for pharmacoepidemiology" (RECORD-PE) statement. We used descriptive analyses to examine how authors reported data source, study design, data analysis, and interpretation of findings.ResultsA total of 222 studies were included, of which 118 (53.2%) reported type of database used, 17 (7.7%) clearly reported database linkage, and 140 (63.1%) reported coverage of data source. Only 44 (19.8%) studies stated a predefined hypothesis, 127 (57.2%) reported study design, 140 (63.1%) reported statistical models used, 142 (77.6%) reported adjusted estimates, 33 (14.9%) mentioned sensitivity analyses, and 39 (17.6%) made a strong claim about treatment effect. Studies published in top 5 general medicine journals were more likely to report the name of data source (94.7% vs. 67.0%) and study design (100% vs. 53.2%) than those in other journals.ConclusionsThe under-reporting of key methodological features in abstracts of RCD studies was common, which would substantially compromise the indexing of this type of literature and prevent the effective use of study findings. Substantial efforts to improve the reporting of abstracts in these studies are highly warranted.
| S-EPMC8742367 | biostudies-literature