Evidence map›Paper›PMID 31245573›Full record

ArticleLearning health systems2018

Opportunities and barriers for pragmatic embedded trials: Triumphs and tribulations.

Joakim Ramsberg, Richard Platt

Abstract read
In one paragraph

Article in Learning health systems, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 1 pooled it
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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

17 citing papers in PubMed, 1 synthesis or guideline 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

2 authors.

Joakim RamsbergDepartment of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston Massachusetts.ORCID 0000-0002-2578-832X
Richard PlattDepartment of Population Medicine Harvard Medical School and Harvard Pilgrim Health Care Institute Boston Massachusetts.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

resultsEmbedded pragmatic clinical trials (PCTs) are set in routine health care, have broad eligibility criteria, and use routinely collected electronic data. Many consider them a breakthrough innovation in clinical research and a necessary step in clinical trial development. To identify barriers and success factors, we reviewed published embedded PCTs and interviewed 30 researchers and clinical leaders in 7 US delivery systems. LITERATURE: We searched PubMed, the Cochrane library, and clinicaltrials.gov for studies reporting embedded PCTs. We identified 108 embedded PCTs published in the last 10 years. The included studies had a median of 5540 randomized patients, addressed a variety of diseases, and practice settings covering a broad range of interventions. Eighty-one used cluster randomization. The median cost per patient was $97 in the 64 trials for which it was possible to obtain cost data. INTERVIEWS: Delivery systems required research studies to align with operational priorities, existing information technology capabilities, and standard quality improvement procedures. Barriers that were identified included research governance, requirements for processes that were incompatible with clinical operations, and unrecoverable costs.

conclusionsEmbedding PCTs in delivery systems can provide generalizable knowledge that is directly applicable to practice settings at much lower cost than conventional trials. Successful embedding trials require accommodating delivery systems' needs and priorities.

Identifiers

PMID31245573
PMCPMC6508852

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.