Evidence map›Paper›PMID 28176926›Full record

ArticlePragmatic and observational research2017

Parental opinions regarding an opt-out consent process for inpatient pediatric prospective observational research in the US.

Danielle M Fernandes, Allison P Roland, Marilyn C Morris

Abstract read
In one paragraph

Article in Pragmatic and observational research, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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

2 citing papers in PubMed.

  1. Article
  2. 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

3 authors.

Danielle M FernandesThe Children's Hospital of New York.
Allison P RolandPostbaccalaureate Prehealth Studies Program, NYU College of Arts and Science.
Marilyn C MorrisDepartment of Pediatrics, Columbia University Medical Center, New York, NY, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo explore parental opinions regarding opt-out consent for inpatient pediatric prospective observational research in the US. STUDY

designA series of handouts describing hypothetical observational research studies with opt-out consent were reviewed by parents of hospitalized children. A verbal survey explored parental opinions about the proposed consent process.

resultsA total of 166 parents reviewed the handout and completed the survey. Only 2/166 parents (1.2%) objected to the study described and another 10 (6.0%) cited concern about the privacy of their child's medical information. A total of 157 parents were asked "Is it okay to tell you about this kind of research using this handout?" - 116 (74%) responded positively, 19 (12%) responded negatively, and 21 (13%) made an indeterminate or neutral response. When parents were asked to recommend a specific consent approach for observational research, 86 (52%) chose an opt-in approach, 54 (33%) chose opt-out, and 25 (15%) chose "no consent needed". There were no significant associations between parental preferences and whether the child was admitted to the intensive care unit vs. pediatric ward, and no significant difference found based on type of handout reviewed (generic vs. study-specific).

conclusionFew parents voiced objection to a hypothetical opt-out consent process for inpatient pediatric prospective observational research. When asked to recommend a specific consent approach, though, approximately half chose an opt-in approach. These data suggest that an opt-out consent process for observational inpatient research is likely to be acceptable to parents, but assessment of an opt-out consent process in a real-world setting is needed.

Indexed as

informed consentminimal riskresearch ethics

Identifiers

PMID28176926
PMCPMC5266095

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
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.