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The REporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) Statement: Methods for Arriving at Consensus and Developing Reporting Guidelines
Open accessAbstract
OBJECTIVE: Routinely 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. METHODS: Two 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. RESULTS: The 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. CONCLUSIONS: The 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.
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“Extensive efforts were made to include a broad representation of stakeholders in the creation of these guidelines.”
From The Reporting of Studies Conducted Using Observational Routinely-Collected Health Data (RECORD) statement. (2015) · cites this paper as [16]
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BackgroundThe aetiology of extreme tall stature in a screened Finnish paediatric population
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“Methods We retrospectively analyzed data collected in real time during deliveries in a single medical center and report our findings in accordance with the Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and Reporting of studies Conducted using Observational Routinely collected Data (RECO…”
MethodLennox, L., Myint, P. K., Baliga, S., & Farrow, L. (2024) · Journal of Clinical Medicine · doi:10.3390/jcm13092546 · Cited by 4
“This study was reported in accordance with the REporting of studies Conducted using Observational Routinely collected health data (RECORD) statement [24].”
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“To improve the readout and interpretation of this study, Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) and REporting of studies Conducted using Observational Routinely-collected Data (RECORD) guidelines were closely followed [27,28].”
MethodThe Function of Bed Management in Pandemic Times—A Case Study of Reaction Time and Bed Reconversion
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“As Benchimol and colleagues [18] illustrated in their work on routinely collected healthcare data in the absence of a previous research aim, it was necessary to create a methodological instrument that could address the growing availability of this type of information in the attempt to use it to improve not only clinic…”
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“This data linkage study was approved by the NSW Population and Health Services Research Ethics Committee (HREC/14/CIPHS/67) and is reported according to the REporting of studies Conducted using Observational Routinely-collected Data (RECORD) guidelines [16].”
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“Most existing work in this field has primarily focused on qualitative checklists or structured reporting frameworks 13 .”
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“Research undertaken to develop the ‘Reporting of studies conducted using observational routinely-collected data’ (RECORD) statement also does not highlight the issue of reporting the dose used or adherence to the medicine under study [3].”
BackgroundClinical Research Informatics: Supporting the Research Study Lifecycle
Johnson, S. B. (2017) · Yearbook of Medical Informatics · doi:10.1055/s-0037-1606503 · Cited by 3
Severe alcohol withdrawal syndrome: review of the literature
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MethodPatient Care Gaps Prior to Maintenance Dialysis Initiation: A Population-Based Retrospective Study
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Benchimol, E. I., Smeeth, L. L., Guttmann, A., Harron, K. L., Hemkens, L. G., Moher, D., Petersen, I., Sørensen, H. T., von Elm, E. B., & Langan, S. (2016) · Zeitschrift für Evidenz Fortbildung und Qualität im Gesundheitswesen · doi:10.1016/j.zefq.2016.07.010 · Cited by 98
Self-citationTahery, I., Ahmadzai, F., Valkenburg, C., Slot, D. E., & van der Weijden, G. A. (2023) · International Journal of Dental Hygiene · doi:10.1111/idh.12665 · Cited by 1
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Paolucci, M., Urbinati, G., Gentile, M., Forlivesi, S., Arnone, G., Migliaccio, L., Viola, M. M., Galluzzo, S., Fanciulli, C., Sebastiani, M., et al. (2026) · Journal of clinical lipidology · doi:10.1016/j.jacl.2026.01.015 · Cited by 1
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“The reporting in this study conforms to the RECORD statement [9].”
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“Our survey has been reported in line with the RE-porting of studies Conducted using Observational Routinely collected health Data, [13] strengthening the reporting of observational studies in epidemiology declaration.”
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Metadata
- Authors
- Nicholls, S. G., Quach, P., von Elm, E., Guttmann, A., Moher, D., Petersen, I., Sørensen, H. T., Smeeth, L., Langan, S. M., & Benchimol, E. I.
- Affiliations
- University of Ottawa (CA)
- Institute for Clinical Evaluative Sciences (CA)
- University of Toronto (CA)
- University College London (GB)
- Aarhus University (DK)
- London School of Hygiene & Tropical Medicine (GB)
- Corresponding author
- Benchimol, Eric I.
- ORCID
- Venue
- PLOS ONE
- Publisher
- Public Library of Science (PLoS)
- Published
- 2015-05-12
- Volume
- 10
- Issue
- 5
- Pages
- e0125620
- ISSN
- 1932-6203 (ISSN-L)
- PMC
- PMC4428635
- OpenAlex
- W1866803133
- Cited by
- 217
- References
- 26
- Citations by year
- 2026: 22 · 2025: 23 · 2024: 24 · 2023: 23 · 2022: 21 · 2021: 18 · 2020: 22 · 2019: 18 · 2018: 11 · 2017: 14 · 2016: 14 · 2015: 7
- FWCI
- 13.97
- Type
- journal article
- Language
- en
- Open access
- gold
- doi.org
- Licence
- Locations
- PLoS ONE (publishedVersion, cc-by)
- PubMed Central (publishedVersion, cc-by)
- PubMed (publishedVersion)
- LSHTM Research Online (London School of Hygiene and Tropical Medicine) (acceptedVersion)
- IRIS (submittedVersion)
- RePEc: Research Papers in Economics (submittedVersion)
- DOAJ (DOAJ: Directory of Open Access Journals) (submittedVersion, cc-by-sa)
- UCL Discovery (University College London) (submittedVersion)
- Figshare (submittedVersion, cc-by)
- SERVAL (Université de Lausanne) (submittedVersion, other-oa)
- Funders
- National Science Foundation
- Aarhus Universitet
- University of Ottawa
- Wellcome Trust (098504)
- Canadian Child Health Clinician Scientist Program
- National Institute for Health and Care Research (NIHR/CS/010/014, NF-SI-0510-10090)
- Schweizerischer Nationalfonds zur Förderung der Wissenschaftlichen Forschung (130512)
- Lundbeckfonden (R155-2014-2647)
- Novo Nordisk
- Novo Nordisk Fonden (NNF14SA0015794)
- H. Lundbeck A/S
- Canadian Institutes of Health Research (130512)
- Medical Research Council (MR/K006584/1)
- Topics
- Social Sciences › Decision Sciences › Statistics, Probability and Uncertainty › Meta-analysis and systematic reviews
- Social Sciences › Sociology and Political Science › Delphi Technique in Research
- Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Epidemiology
- Keywords
- routinely collected health data, reporting guidelines, stakeholder consensus, Delphi method, observational studies, data characteristics, STROBE
- MeSH terms
- Adolescent, Adult, Aged, Database Management Systems, Female, Humans, Male, Medical Records, Middle Aged, Surveys and Questionnaires, Guidelines as Topic, Consensus, Observational Studies as Topic
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