Setting the RECORD straight: developing a guideline for the REporting of studies Conducted using Observational Routinely collected Data.

作者: Sinéad M Langan , Eric I Benchimol , Astrid Guttmann , David Moher , Irene Petersen

DOI: 10.2147/CLEP.S36885

关键词:

摘要: Recent technological developments in recording health care delivery have led to major research opportunities for epidemiologists and others. There has been a dramatic increase the availability of “routine data” purposes, including data from electronic medical records, administrative billing disease registries, sources sociodemographic data. Examples routine include records UK Clinical Practice Research Database, Surveillance, Epidemiology End Results Medicare, registry Danish National Registry Patients. The key aspect that differentiates other is reasons which were collected, since are not specifically collected purposes. These increasingly available various settings geographic locations. They present innovative, efficient, cost-effective prospects with answer questions. However, use these leads specific challenges researchers policymakers clinicians using studies based on such data. At present, strengths, limitations, biases unclear. This confusion compounded by incomplete or inadequate reporting this type research. An example undertaken validate quality derived records. Two recent systematic reviews demonstrated poor validation sources, thereby hampering their utility.1,2 In last few years, increasing emphasis placed improving view usefulness findings.3–5 In 2008, an international collaboration produced Strengthening Reporting Observational Studies (STROBE) statement improve three types observational research, ie, cross-sectional, case-control, cohort studies.6 STROBE endorsed more than 100 journals. Most routinely design, so guidelines should apply studies. due general nature STROBE, issues related addressed. REporting Conducted Routinely Data (RECORD) was established explore address explored amongst stakeholders during workshop convened at Infectious Disease Network Primary Care Database Symposium (January 27, 2012, London, UK). Over people participated workshop, five conveners initiative. Strong interest expressed idea developing guideline agreement areas warranted extension statement. Some discussed meeting, likely be themes when data, included description database characteristics, diagnostic codes algorithms identify exposures outcomes, record linkage methodology. covered checklists. Therefore, we proceeding formal development process, close members group, ensure consistent methods make valuable addition RECORD initiative created as collaborative process. aims develop checklist enhance transparent sources. The steering committee selected broad representation expertise experience different representing diverse geographical locations rigorous guidelines. addition, working group wide range will appointed inform A broadly representative used contribute modified Delphi consensus component development. If readers editorial feel they could usefully stakeholder level, please visit website (http://www.record-statement.org). Your input most welcome. Following brainstorming session January search Enhancing QUAlity Transparency Of (EQUATOR) library carried out. EQUATOR (http://www.equator-network.org) committed upholding accurate scientific publications; network hosts comprehensive guidelines.7 Three checklists identified aim aid conduct critical appraisal comparative effectiveness research.8–10 focus primarily rather focused therefore do research; additionally widely accepted journal editors developed part STROBE. Formal multidisciplinary expert involvement authors, help transparency growing field research. Development follow process proposed previously guidelines.11–14 Members executive also committees RECORD. recommends phases optimally, initial steps, pre-meeting activities, face-to-face post-meeting post-publication activities. steps providing evidence about reports undertaking exercise. Both activities completed presented meeting invited stakeholders. To facilitate uptake, dissemination, implementation strategies, creation recommended can act important portal communication interested parties enable invitation criticisms recommendations guideline. Dissemination, endorsement, them impact. As energy invested into maximizing publication strategy encouraging endorsement adherence start early stage closely outset Attendance presentations relevant meetings methodologists success We work encourage individuals submitting anticipate evaluating whether improves completeness others likewise. RECORD set standard sources. Furthermore, tool review literature methodological concern, importantly, adequate allow consumers (including editors, peer reviewers, scientists, clinicians, policy makers) understand work, enabling deduce its internal external validity. introduction knowledge skills those academia industry. Transparent public engagement science.

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