Evidence map›Paper›PMID 29667543›Full record

ArticleJournal of empirical research on human research ethics : JERHRE2018

Assessment of Parents'/Guardians' Initial Comprehension and 1-Day Recall of Elements of Informed Consent Within a Mozambican Study of Pediatric Bacteremia.

Ezequiel B Ossemane, Troy D Moon, Jahit Sacarlal, Esperança Sevene, Darlene Kenga, Wu Gong, Elizabeth Heitman

Abstract read
In one paragraph

Article in Journal of empirical research on human research ethics : JERHRE, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers, 2 of them syntheses that pooled it.

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

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, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  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

7 authors.

Ezequiel B Ossemane1 Vanderbilt Institute for Global Health, Nashville, TN, USA.
Troy D Moon1 Vanderbilt Institute for Global Health, Nashville, TN, USA.
Jahit Sacarlal2 Eduardo Mondlane University, Maputo, Mozambique.
Esperança Sevene2 Eduardo Mondlane University, Maputo, Mozambique.
Darlene Kenga2 Eduardo Mondlane University, Maputo, Mozambique.
Wu Gong3 Vanderbilt University, Nashville, TN, USA.ORCID 0000-0002-0336-7137
Elizabeth Heitman1 Vanderbilt Institute for Global Health, Nashville, TN, USA.ORCID 0000-0002-4855-8551

Funding

VU-Mozambique Collaborative Research Ethics Education ProgramR25TW009722 · FIC · VANDERBILT UNIVERSITY MEDICAL CENTER · PI ELIZABETH HEITMAN, D. Troy Moon · 2014 to 2026
$3.0M
Bacteremia in HIV-infected children under 5 years old hospitalized in MozambiqueR01AI112295 · NIAID · EDUARDO MONDLANE UNIVERSITY · PI MOON, D. TROY, SACARLAL, JAHIT · 2014 to 2018
$739k
FIC NIH HHS R25 TW009722NIAID NIH HHS R01 AI112295
6 · The paper itself

Abstract

Participants' understanding of key elements of a research protocol is essential to their ethical enrollment in the study. Ongoing participation should be based on continued comprehension and consent, which presumes a high degree of recall. Many obstacles can prevent full understanding of information about the research protocol. This study's aim was to evaluate the comprehension and 1-day recall of the elements of informed consent by the parents/guardians of children enrolled in a clinical study in Mozambique. We developed a 10-question test based on the study's informed consent document. We asked participants to answer questions shortly after being read the informed consent document and again the following day. Participants who did not demonstrate good or reasonable understanding at enrollment were provided the information again as a refresher. Overall high rates of initial comprehension demonstrate that attention to the informed consent process can result in Mozambicans' informed, voluntary participation in clinical trials.

Indexed as

BacteremiaComprehensionConsent FormsInformed ConsentMental RecallParentsAdultBiomedical ResearchChild, PreschoolFemaleHumansInfantLegal GuardiansMaleMozambiqueResearch Designelements of informed consentethicsinformed consentMozambiquerecallunderstanding

Identifiers

PMID29667543
PMCPMC5993589

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.