Evidence map›Paper›PMID 26713336›Full record

Trial reportEuropean journal of clinical pharmacology2016

Improved participants' understanding in a healthy volunteer study using the SIDCER informed consent form: a randomized-controlled study.

Nut Koonrungsesomboon, Supanimit Teekachunhatean, Nutthiya Hanprasertpong, Junjira Laothavorn, Kesara Na-Bangchang, Juntra Karbwang

Abstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed, 1 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

9 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. 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

6 authors.

Nut KoonrungsesomboonDepartment of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan.
Supanimit TeekachunhateanDepartment of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
Nutthiya HanprasertpongDepartment of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, 50200, Thailand.
Junjira LaothavornChulabhorn International College of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Kesara Na-BangchangChulabhorn International College of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Juntra KarbwangDepartment of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan. karbwangj@nagasaki-u.ac.jp.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThis study aimed to evaluate the applicability of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) in a clinical pharmacokinetic study by comparing the volunteers' understanding of the enhanced ICF (developed based on the SIDCER methodology) and the conventional ICF (which was previously approved by local Ethics Committee and used in the clinical study).

methodsA total of 550 volunteers were randomly assigned to read either the enhanced ICF or the conventional ICF (1:1) in a mock informed consent approach and subsequently performed the post-test questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥ 80 %; the secondary endpoints were the total score of the post-test, the score of the categorized ICF elements, and time spent for participation.

resultsThe proportion of the participants in the enhanced ICF group who achieved the primary endpoint was significantly higher than the conventional ICF group (82.2 % vs. 60.4 %, p < 0.001). The participants in the enhanced ICF group obtained higher scores and spent less time in reading the given ICF and answering the post-test than those in the conventional ICF group (total score 19/21 vs. 18/21, p < 0.001; time spent 20 min vs. 25 min, p < 0.001).

conclusionThe enhanced ICF improved the understanding of the participants in this study. This demonstrates the applicability of the SIDCER ICF principles and its template in the development of an enhanced ICF for improving the quality of ICFs and subjects' understanding in clinical research.

trial registrationTCTR20140727001.

Indexed as

ComprehensionConsent FormsHealthy VolunteersInformed ConsentAdolescentAdultAgedBiomedical ResearchFemaleHumansMaleMiddle AgedResearch DesignSurveys and QuestionnairesYoung AdultClinical researchClinical studyHealthy subjectsHealthy volunteersInformed consentUnderstanding

Identifiers

PMID26713336
PMCPMC4792335

What Socratic 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 Socratic graph.