Evidence map›Paper›PMID 19174434›Full record

SynthesisBMJ (Clinical research ed.)2009

Use of primary care electronic medical record database in drug efficacy research on cardiovascular outcomes: comparison of database and randomised controlled trial findings.

Richard L Tannen, Mark G Weiner, Dawei Xie

Registry-linked trialOpen access · bronzeAbstract readComparative StudyMeta-Analysis
In one paragraph

Synthesis in BMJ (Clinical research ed.), 2009. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01141439 (A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI), which is not on this map. Cited by 62 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
62citing papers in PubMed, 1 pooled it
7.1field-weighted citation impact, top 2% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01141439 completednot on this map

A Retrospective Evaluation of the Effectiveness and Cost-effectiveness of HFA-BDP MDI (Qvar®) Compared With CFC-BDP MDI and FP MDI Used in the Management of Asthma in a Representative UK UK Primary Care Population

TypeobservationalSponsorResearch in Real-Life LtdRan2001 to 2010Enrolled815,377ConditionsAsthmaArmsExtra-fine hydrofluoroalkane-beclomethasone dipropionate, Fluticasone propionate, Beclomethasone dipropionate, fluticasone propionate, Chlorofluorocarbon beclomethasone dipropionate
3 · Its place in the literature

Who cites it

62 citing papers in PubMed, 1 synthesis or guideline pooled it, 144 citations in OpenAlex.

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  13. The Effect of Buprenorphine on Human Immunodeficiency Virus Viral Suppression.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2021
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2 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

3 authors at 1 institution in 1 country.

Richard L TannenUniversity of Pennsylvania School of Medicine, 295 John Morgan Building, 36th and Hamilton Walk, Philadelphia, PA 19104, USA. tannen@mail.med.upenn.edu
Mark G Weiner
Dawei Xie
University of Pennsylvania · US

Funding

Electronic Clinical Records for Medical ResearchR01HL073911 · NHLBI · UNIVERSITY OF PENNSYLVANIA · PI TANNEN, RICHARD L · 2003 to 2006
$2.5M
NHLBI NIH HHS R01-HL 073911
6 · The paper itself

Abstract

objectivesTo determine whether observational studies that use an electronic medical record database can provide valid results of therapeutic effectiveness and to develop new methods to enhance validity.

designData from the UK general practice research database (GPRD) were used to replicate previously performed randomised controlled trials, to the extent that was feasible aside from randomisation. Studies Six published randomised controlled trials.

main outcome measureCardiovascular outcomes analysed by hazard ratios calculated with standard biostatistical methods and a new analytical technique, prior event rate ratio (PERR) adjustment.

resultsIn nine of 17 outcome comparisons, there were no significant differences between results of randomised controlled trials and database studies analysed using standard biostatistical methods or PERR analysis. In eight comparisons, Cox adjusted hazard ratios in the database differed significantly from the results of the randomised controlled trials, suggesting unmeasured confounding. In seven of these eight, PERR adjusted hazard ratios differed significantly from Cox adjusted hazard ratios, whereas in five they didn't differ significantly, and in three were more similar to the hazard ratio from the randomised controlled trial, yielding PERR results more similar to the randomised controlled trial than Cox (P<0.05).

conclusionsAlthough observational studies using databases are subject to unmeasured confounding, our new analytical technique (PERR), applied here to cardiovascular outcomes, worked well to identify and reduce the effects of such confounding. These results suggest that electronic medical record databases can be useful to investigate therapeutic effectiveness.

Indexed as

Medical Records Systems, ComputerizedCardiovascular DiseasesFamily PracticeProportional Hazards ModelsRandomized Controlled Trials as TopicTreatment Outcome

Identifiers

PMID19174434
PMCPMC2769067
OpenAlexW1993231267

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.