Evidence map›Paper›PMID 30718353›Full record

ArticleCMAJ open

Current use and costs of electronic health records for clinical trial research: a descriptive study.

Kimberly A Mc Cord, Hannah Ewald, Aviv Ladanie, Matthias Briel, Benjamin Speich, Heiner C Bucher, Lars G Hemkens, RCD for RCTs initiative and the Making Randomized Trials More Affordable Group

Abstract read
In one paragraph

Article in CMAJ open. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 36 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
36citing papers in PubMed, 4 pooled it
–field-weighted citation impact
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

36 citing papers in PubMed, 4 syntheses or guidelines pooled it.

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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

8 authors.

Kimberly A Mc CordBasel Institute for Clinical Epidemiology and Biostatistics (Mc Cord, Ewald, Ladanie, Briel, Speich, Bucher, Hemkens), Department of Clinical Research, University Hospital Basel, University of Basel; University Medical Library (Ewald), University of Basel; Swiss Tropical and Public Health Institute (Ladanie), University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact (Briel), McMaster University, Hamilton, Ont.
Hannah EwaldBasel Institute for Clinical Epidemiology and Biostatistics (Mc Cord, Ewald, Ladanie, Briel, Speich, Bucher, Hemkens), Department of Clinical Research, University Hospital Basel, University of Basel; University Medical Library (Ewald), University of Basel; Swiss Tropical and Public Health Institute (Ladanie), University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact (Briel), McMaster University, Hamilton, Ont.
Aviv LadanieBasel Institute for Clinical Epidemiology and Biostatistics (Mc Cord, Ewald, Ladanie, Briel, Speich, Bucher, Hemkens), Department of Clinical Research, University Hospital Basel, University of Basel; University Medical Library (Ewald), University of Basel; Swiss Tropical and Public Health Institute (Ladanie), University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact (Briel), McMaster University, Hamilton, Ont.
Matthias BrielBasel Institute for Clinical Epidemiology and Biostatistics (Mc Cord, Ewald, Ladanie, Briel, Speich, Bucher, Hemkens), Department of Clinical Research, University Hospital Basel, University of Basel; University Medical Library (Ewald), University of Basel; Swiss Tropical and Public Health Institute (Ladanie), University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact (Briel), McMaster University, Hamilton, Ont.
Benjamin SpeichBasel Institute for Clinical Epidemiology and Biostatistics (Mc Cord, Ewald, Ladanie, Briel, Speich, Bucher, Hemkens), Department of Clinical Research, University Hospital Basel, University of Basel; University Medical Library (Ewald), University of Basel; Swiss Tropical and Public Health Institute (Ladanie), University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact (Briel), McMaster University, Hamilton, Ont.
Heiner C BucherBasel Institute for Clinical Epidemiology and Biostatistics (Mc Cord, Ewald, Ladanie, Briel, Speich, Bucher, Hemkens), Department of Clinical Research, University Hospital Basel, University of Basel; University Medical Library (Ewald), University of Basel; Swiss Tropical and Public Health Institute (Ladanie), University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact (Briel), McMaster University, Hamilton, Ont.
Lars G HemkensBasel Institute for Clinical Epidemiology and Biostatistics (Mc Cord, Ewald, Ladanie, Briel, Speich, Bucher, Hemkens), Department of Clinical Research, University Hospital Basel, University of Basel; University Medical Library (Ewald), University of Basel; Swiss Tropical and Public Health Institute (Ladanie), University of Basel, Basel, Switzerland; Department of Health Research Methods, Evidence, and Impact (Briel), McMaster University, Hamilton, Ont. lars.hemkens@usb.ch.
RCD for RCTs initiative and the Making Randomized Trials More Affordable Group

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundElectronic health records (EHRs) may support randomized controlled trials (RCTs). We aimed to describe the current use and costs of EHRs in RCTs, with a focus on recruitment and outcome assessment.

methodsThis descriptive study was based on a PubMed search of RCTs published since 2000 that evaluated any medical intervention with the use of EHRs. Cost information was obtained from RCT investigators who used EHR infrastructures for recruitment or outcome measurement but did not explore EHR technology itself.

resultsWe identified 189 RCTs, most of which (153 [81.0%]) were carried out in North America and were published recently (median year 2012 [interquartile range 2009-2014]). Seventeen RCTs (9.0%) involving a median of 732 (interquartile range 73-2513) patients explored interventions not related to EHRs, including quality improvement, screening programs, and collaborative care and disease management interventions. In these trials, EHRs were used for recruitment (14 [82%]) and outcome measurement (15 [88%]). Overall, in most of the trials (158 [83.6%]), the outcome (including many of the most patient-relevant clinical outcomes, from unscheduled hospital admission to death) was measured with the use of EHRs. The per-patient cost in the 17 EHR-supported trials varied from US$44 to US$2000, and total RCT costs from US$67 750 to US$5 026 000. In the remaining 172 RCTs (91.0%), EHRs were used as a modality of intervention.

interpretationRandomized controlled trials are frequently and increasingly conducted with the use of EHRs, but mainly as part of the intervention. In some trials, EHRs were used successfully to support recruitment and outcome assessment. Costs may be reduced once the data infrastructure is established.

Identifiers

PMID30718353
PMCPMC6375253

What OpenQuestion holds

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Registered trials

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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.