Evidence map›Paper›PMID 39702510›Full record

ArticleTrials2024

Irregular assessment times in pragmatic randomized clinical trials.

Andrea Apter, Frances K Barg, Sanjib Basu, Alex Federman, Winifred J Hamilton, Jerry A Krishnan, Tianjing Li, Russell Localio, Christine Pindle, Daniel O Scharfstein and 2 more

Abstract readLetter
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

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

1 citing paper in PubMed.

  1. Review
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

12 authors.

Andrea ApterDepartment of Allergy & Immunology, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Frances K BargDepartment of Family Medicine and Community Health, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Sanjib BasuDivision of Epidemiology and Biostatistics, School of Public Health, University of Illinois Chicago, Chicago, IL, USA.
Alex FedermanDivision of General Internal Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA.
Winifred J HamiltonDepartments of Family & Community Medicine, Medicine, and Neurosurgery, Baylor College of Medicine, Houston, TX, USA.
Jerry A KrishnanBreathe Chicago Center, Division of Pulmonary, Critical Care, Sleep, and Allergy, University of Illinois Chicago, Chicago, IL, USA.
Tianjing LiDepartment of Ophthalmology, School of Medicine, University of Colorado Anschutz Medical Campus, Aurora, CO, USA.
Russell LocalioDepartment of Biostatistics, Epidemiology and Informatics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, USA.
Christine PindleCertified Nursing Assistant, Community Advisory Board HAP3 Study, University of Pennsylvania, Philadelphia, PA, USA.
Daniel O ScharfsteinDepartment of Population Health Sciences, Division of Biostatistics, School of Medicine, The University of Utah, Spencer Fox Eccles, Salt Lake City, UT, USA. daniel.scharfstein@hsc.utah.edu.
Justin D SmithDepartment of Population Health Sciences, Division of Health System Innovation and Research, Spencer Fox Eccles School of Medicineat , The University of Utah, Salt Lake City, UT, USA.
Kaharu SuminoDepartment of Medicine, Division of Pulmonary and Critical Care Medicine, Washington University School of Medicine, St. Louis, MO, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Deviation from protocolized assessment times is commonplace in pragmatic randomized clinical trials. Working with a stakeholder advisory board for a Patient-Centered Outcomes Research Institute®-funded project on statistical methods for handling potential biases introduced by irregular assessment times, we identified reasons for off-schedule or missed assessments. We used the Consolidated Framework for Implementation Research 2.0 to organize our findings. We conjectured that timely completion of outcome assessments is a function of multiple determinants, only some related to participants' health status. We identified potential determinants that can be modified during the protocol design stage and can be reassessed and mitigated during trial implementation stage. Research to more formally evaluate our findings is warranted as well as studies to evaluate multi-level strategies that reduce off-schedule or missed assessments.

Indexed as

Pragmatic Clinical Trials as TopicResearch DesignData Interpretation, StatisticalHumansRandomized Controlled Trials as TopicTime FactorsTreatment OutcomeDeterminants of off-schedule or missed assessmentsImplementation scienceStakeholder perspectives

Identifiers

PMID39702510
PMCPMC11660989

What Socratic holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

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 Socratic graph.