Evidence map›Paper›PMID 27838760›Full record

Trial reportEuropean journal of clinical pharmacology2017

Improved participants' understanding of research information in real settings using the SIDCER informed consent form: a randomized-controlled informed consent study nested with eight clinical trials.

Nut Koonrungsesomboon, Thipaporn Tharavanij, Kittichet Phiphatpatthamaamphan, Ratha-Korn Vilaichone, Sudsayam Manuwong, Parichat Curry, Sith Siramolpiwat, Thanachai Punchaipornpon, Supakit Kanitnate, Nattapol Tammachote and 7 more

Abstract readRandomized Controlled Trial
PubMed Publisher
In one paragraph

Trial report in European journal of clinical pharmacology, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
4citing 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

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

  1. Pooled it
  2. Trial
  3. Article
  4. Article
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

17 authors.

Nut KoonrungsesomboonDepartment of Clinical Product Development, Institute of Tropical Medicine, Nagasaki University, 1-12-4 Sakamoto, Nagasaki, 852-8523, Japan.
Thipaporn TharavanijDepartment of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Kittichet PhiphatpatthamaamphanDepartment of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Ratha-Korn VilaichoneDepartment of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Sudsayam ManuwongDepartment of Anesthesiology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Parichat CurryDepartment of Anesthesiology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Sith SiramolpiwatDepartment of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Thanachai PunchaipornponDepartment of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Supakit KanitnateDepartment of Orthopedics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Nattapol TammachoteDepartment of Orthopedics, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Rodsarin YamprasertCenter of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, 12121, Thailand.
Waipoj ChanvimaluengDepartment of Otolaryngology, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Ruchirat KaewkumpaiCenter of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, 12121, Thailand.
Soiphet NetanongCenter of Excellence in Applied Thai Traditional Medicine Research, Thammasat University, Pathum Thani, 12121, Thailand.
Peerapong KitipawongDepartment of Medicine, Faculty of Medicine, Thammasat University, Pathum Thani, 12121, Thailand.
Paskorn SritipsukhoDepartment of Pediatrics, Faculty 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 test the applicability and effectiveness of the principles and informed consent form (ICF) template proposed by the Strategic Initiative for Developing Capacity in Ethical Review (SIDCER) across multiple clinical trials involving Thai research participants with various conditions.

methodsA single-center, randomized-controlled study nested with eight clinical trials was conducted at Thammasat University Hospital, Thailand. A total of 258 participants from any of the eight clinical trials were enrolled and randomly assigned to read either the SIDCER ICF (n = 130) or the conventional ICF (n = 128) of the respective trial. Their understanding of necessary information was assessed using the post-test questionnaire; they were allowed to consult a given ICF while completing the questionnaire. The primary endpoint was the proportion of the participants who had the post-test score of ≥80%, and the secondary endpoint was the total score of the post-test.

resultsThe proportion of the participants in the SIDCER ICF group who achieved the primary endpoint was significantly higher than that of the conventional ICF group (60.8 vs. 41.4%, p = 0.002). The total score of the post-test was also significantly higher among the participants who read the SIDCER ICF than those who read the conventional ICF (83.3 vs. 76.0%, p < 0.001).

conclusionsThe present study demonstrated that the SIDCER ICF was applicable and effective to improve Thai research participants' understanding of research information in diverse clinical trials. Using the SIDCER ICF methodology, clinical researchers can improve the quality of ICFs for their trials.

Indexed as

ComprehensionConsent FormsAdolescentAdultAgedAged, 80 and overBiomedical ResearchFemaleHumansMaleMiddle AgedPatient Education as TopicSurveys and QuestionnairesThailandYoung AdultClinical studiesClinical trialsComprehensionConsent formsInformed consentUnderstanding

Identifiers

PMID27838760

What OpenQuestion holds

Textmetadata
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 OpenQuestion graph.