With Great Data Comes Great Responsibility
EpidemiologyPublished 2 April 2011
Miguel A. Hernán
Citations64
SJR quartileQ1
SJR score1.83
SNIP1.60
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ObjectiveStudy objective
MethodsResearch methodology
PopulationPopulation studied
Sample sizeSample sizes
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TL;DR
This issue of EPIDEMIOLOGY includes four pieces on the use of observational healthcare databases, all written by leading epidemiologists in this old new field, and the importance of guidelines for the proper conduct and reporting of comparative effectiveness research using observational data.
Keywords
Economics, Econometrics and FinanceHealth Professions
BMC MedicineCONSORT 2010 Statement: updated guidelines for reporting parallel group randomised trials
13,537 Citations2010the CONSORT Group, Kenneth F. Schulz +2 more
PLoS MedicineCONSORT 2010 Statement: Updated Guidelines for Reporting Parallel Group Randomised Trials
2,314 Citations2010Kenneth F. Schulz, Douglas G. Altman +2 more
The latest version of the CONSORT statement, CONSORT 2010, is described, which updates the reporting guideline based on new methodological evidence and accumulating experience.
BMJImproving the reporting of pragmatic trials: an extension of the CONSORT statement
1,829 Citations2008Merrick Zwarenstein, Shaun Treweek +7 more
Eight CONSORT checklist items for reporting of pragmatic trials are recommended, including the background, participants, interventions, outcomes, sample size, blinding, participant flow, and generalisability of the findings.
EpidemiologyThe Hazards of Hazard Ratios
1,336 Citations2009Miguel A. Hernán
By using a randomized experiment as an example, the discussion can focus on the shortcomings of the HR, setting aside issues of confounding and other serious problems that arise in observational studies.
Annals of EpidemiologySurveillance and ascertainment of cardiovascular events
683 Citations1995Diane G. Ives, Annette L. Fitzpatrick +6 more
The CHS techniques are a successful model for complete ascertainment, investigation, and documentation of events in an older cohort.
NeurologyRecombinant hepatitis B vaccine and the risk of multiple sclerosis
296 Citations2004Miguel A. Hernán, Susan S. Jick +2 more
Statistical Methods in Medical ResearchObservational data for comparative effectiveness research: An emulation of randomised trials of statins and primary prevention of coronary heart disease
285 Citations2011Goodarz Danaei, Luis A. Garcı́a Rodrı́guez +3 more
Two approaches to conduct the analogues of per-protocol and as-treated analyses after further adjusting for measured time-varying confounding and selection bias using inverse-probability weighting are explained.
Journal of General Internal MedicineRelationship of Opioid Use and Dosage Levels to Fractures in Older Chronic Pain Patients
275 Citations2010Kathleen Saunders, Kate M. Dunn +6 more
Higher doses of opioids for chronic non-cancer pain were associated with a 2.00 increase in risk of fracture confirmed by medical record review, and clinicians should consider fracture risk when prescribing higher-dose opioid therapy for older adults.
EpidemiologyNonexperimental Comparative Effectiveness Research Using Linked Healthcare Databases
76 Citations2011Til Stürmer, Michele Jönsson Funk +2 more
The purpose of CER is to assist consumers, clinicians, purchasers, and policymakers to make informed decisions that will improve health care at both the individual and population levels.
EpidemiologyImproving Automated Database Studies
41 Citations2011Wayne A. Ray
It is undisputed that automated databases have the potential to enable very large retrospective studies of both relative safety and efficacy that would be infeasible with traditional methods, but this potential must be balanced against the nontrivial limitations of these data systems.
EpidemiologyThe New World of Data Linkages in Clinical Epidemiology
27 Citations2011Noel S. Weiss
The conduct of research in clinical epidemiology can be facilitated by having access to data on a large number of patients at relatively low cost, according to the availability of computerized databases with information on illness in populations.
EpidemiologyMaking Observational Studies Count
26 Citations2011Nancy A Dreyer
There is substantial interest in using observational epidemiologic research in combination with randomized clinical trials (RCTs) and meta-analyses to support decisionmaking by regulators, payers, and physicians, but even well-designed and well-conducted observational studies are often viewed with skepticism.
British Journal of General PracticeCase validation in research using large databases
17 Citations2010Luis A. Garcı́a Rodrı́guez, Ana Ruigómez
Researchers should investigate their information source and how well it covers the diagnosis under study and decide whether to implement a study protocol using CHCDs, according to Khan et al.