Evidence map›Paper›PMID 29625993›Full record

Observational studyCirculation. Cardiovascular quality and outcomes2018

An Observational Study of the Association of Video- Versus Text-Based Informed Consent With Multicenter Trial Enrollment: Lessons From the PALM Study (Patient and Provider Assessment of Lipid Management).

Alexander C Fanaroff, Shuang Li, Laura E Webb, Vincent Miller, Ann Marie Navar, Eric D Peterson, Tracy Y Wang

Registry-linked trialAbstract readComparative StudyObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in Circulation. Cardiovascular quality and outcomes, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02341664 (Patient and Provider Assessment of Lipid Management Registry), which is not on this map. Cited by 14 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
14citing papers in PubMed, 2 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.

NCT02341664 completednot on this map

Patient and Provider Assessment of Lipid Management Registry

Typeobservational_patient_registrySponsorDuke UniversityRan2015 to 2016Enrolled7,658ConditionsHyperlipidemia, Hypercholesterolemia, Cardiovascular Disease, Diabetes
3 · Its place in the literature

Who cites it

14 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Comparative Effectiveness of eConsent: Systematic Review.Journal of medical Internet research · 2023
    Pooled it
  2. Diversity in Alzheimer's disease drug trials: The importance of eligibility criteria.Alzheimer's & dementia : the journal of the Alzheimer's Association · 2022
    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

7 authors.

Alexander C FanaroffDepartment of Medicine (A.C.F., A.M.N., E.D.P., T.Y.W.) and Duke Clinical Research Institute (A.C.F., A.M.N., E.D.P., T.Y.W., S.L., L.E.W., V.M.,), Duke University Medical Center, Durham, NC. alexander.fanaroff@duke.edu.
Shuang LiDepartment of Medicine (A.C.F., A.M.N., E.D.P., T.Y.W.) and Duke Clinical Research Institute (A.C.F., A.M.N., E.D.P., T.Y.W., S.L., L.E.W., V.M.,), Duke University Medical Center, Durham, NC.
Laura E WebbDepartment of Medicine (A.C.F., A.M.N., E.D.P., T.Y.W.) and Duke Clinical Research Institute (A.C.F., A.M.N., E.D.P., T.Y.W., S.L., L.E.W., V.M.,), Duke University Medical Center, Durham, NC.
Vincent MillerDepartment of Medicine (A.C.F., A.M.N., E.D.P., T.Y.W.) and Duke Clinical Research Institute (A.C.F., A.M.N., E.D.P., T.Y.W., S.L., L.E.W., V.M.,), Duke University Medical Center, Durham, NC.
Ann Marie NavarDepartment of Medicine (A.C.F., A.M.N., E.D.P., T.Y.W.) and Duke Clinical Research Institute (A.C.F., A.M.N., E.D.P., T.Y.W., S.L., L.E.W., V.M.,), Duke University Medical Center, Durham, NC.
Eric D PetersonDepartment of Medicine (A.C.F., A.M.N., E.D.P., T.Y.W.) and Duke Clinical Research Institute (A.C.F., A.M.N., E.D.P., T.Y.W., S.L., L.E.W., V.M.,), Duke University Medical Center, Durham, NC.
Tracy Y WangDepartment of Medicine (A.C.F., A.M.N., E.D.P., T.Y.W.) and Duke Clinical Research Institute (A.C.F., A.M.N., E.D.P., T.Y.W., S.L., L.E.W., V.M.,), Duke University Medical Center, Durham, NC.

Funding

Using Data to Drive Change in National CV Care: The Duke CERTSU19HS021092 · AHRQ · DUKE UNIVERSITY · PI PETERSON, ERIC DAVID · 2011 to 2015
$4.2M
Preventing Cardiovascular Disease through Improved Risk Prediction and CommunicationK01HL133416 · NHLBI · DUKE UNIVERSITY · PI NAVAR, ANN MARIE · 2016 to 2020
$707k
AHRQ HHS U19 HS021092NHLBI NIH HHS K01 HL133416
6 · The paper itself

Abstract

backgroundPatient participation in clinical research is low, in part because of the length and complexity of the informed consent process. Video informed consent may enhance the appeal of research and help break down barriers to participation. METHODS AND

resultsThe PALM study (Patient and Provider Assessment of Lipid Management) enrolled 7904 patients at cardiology, endocrinology, and primary care clinics across the United States to evaluate cholesterol management practices. Of 153 participating clinics, 67 (43.8%) secured institutional review board approval to use a tablet-based video informed consent tool that patients could select to navigate through the informed consent process instead of traditional text-based informed consent. At sites without institutional review board approval of video consent, all patients read a text-based informed consent document. Site activation times and enrollment volumes, as well as characteristics of enrolled patients, were compared between sites with and without video consent capability. Sites with video consent capability more often used a central institutional review board (89.6% versus 73.3%), were more often rural (16.7% versus 3.8%), and tended to have fewer providers. Compared with sites without video consent capability, sites with video consent capability had shorter times from site approach to first patient enrollment (median 178 versus 207 days;

conclusionsIn this observational study of recruitment in a multicenter registry, sites approved for video consent use enrolled the same number of patients as sites with only traditional text-based informed consent but had faster speed to first patient enrolled and more often enrolled older and nonwhite patients. Future randomized trials are needed to assess the impact of video consent on enrollment mechanics and demographics. CLINICAL

trial registrationURL: https://www.clinicaltrials.gov. Unique identifier: NCT02341664.

Indexed as

Health Knowledge, Attitudes, PracticeInformed ConsentPamphletsPatient SelectionVideo RecordingAgedBiomarkersCholesterol, LDLClinical Trials as TopicComprehensionDyslipidemiasFemaleHumansMaleMiddle AgedMulticenter Studies as TopicBiomarkersCholesterol, LDLinformed consentpatient participationprimary health careregistriestablets

Identifiers

PMID29625993
PMCPMC5891825

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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.