Evidence map›Paper›PMID 21900445›Full record

ArticleJournal of the American Board of Family Medicine : JABFM

A novel protocol for streamlined IRB review of Practice-based Research Network (PBRN) card studies.

Michelle D Hamilton, Philip A Cola, Joshua J Terchek, James J Werner, Kurt C Stange

Abstract read
In one paragraph

Article in Journal of the American Board of Family Medicine : JABFM. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
0.3field-weighted citation impact, top 30% 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.

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

0 citing papers in PubMed, 1 citations in OpenAlex.

No citing paper in PubMed yet.

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

5 authors at 1 institution in 1 country.

Michelle D HamiltonDepartment of Family Medicine, Research Division, Case Western Reserve University, Cleveland, Ohio 44106, USA. michelle.hamilton@case.edu
Philip A Cola
Joshua J Terchek
James J Werner
Kurt C Stange
Case Western Reserve University · US

Funding

TUMOR METABOLISM PROGRAMP30CA043703 · NCI · CASE WESTERN RESERVE UNIVERSITY · PI MARK R CHANCE · 1987 to 2026
$142.3M
CTSA INFRASTRUCTURE FOR PEDIATRIC RESEARCHUL1RR024989 · NCRR · CASE WESTERN RESERVE UNIVERSITY · PI DAVIS, PAMELA B · 2007 to 2011
$53.7M
NCI NIH HHS P30 CA043703NCI NIH HHS P30 CA43703NCRR NIH HHS UL1 RR024989NCRR NIH HHS UL1RR024989
6 · The paper itself

Abstract

purposeThe "card study," in which clinicians record brief information about patient visits during usual clinical care, has long been a rapid method for conducting descriptive studies in practice-based research networks. Because an increasingly stringent regulatory environment has made conducting card studies difficult, we developed a streamlined method for obtaining card study institutional review board (IRB) approval.

methodsWe developed a protocol for a study of the card study method, allowing new card study proposals of specific research questions to be submitted as addenda to the approved Card Study Protocol.

resultsSeven card studies were proposed and approved under the Card Study Protocol during the first year after implementation, contrasted with one-card study proposed in the previous year. New card study ideas submitted as addenda to an approved protocol appeared to increase IRB comfort with the card study as a minimal risk method while reducing the hurdles to developing new study ideas.

conclusionsA Card Study Protocol allowing new study questions to be submitted as addenda decreases time between idea generation and IRB approval. Shortened turn-around times may be useful for translating ideas into action while reducing regulatory burden.

Indexed as

Ethics Committees, ResearchCommunity-Based Participatory ResearchCommunity NetworksHealth Services ResearchHumansMedical RecordsProgram Development

Identifiers

PMID21900445
PMCPMC4331110
OpenAlexW2116124202

What OpenQuestion holds

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Registered trials

None linked

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.