Evidence map›Paper›PMID 26896964›Full record

Observational studyPediatric surgery international2016

Understanding parental refusal of permission for child participation in surgical prospective trials.

Katherine W Gonzalez, Obinna O Adibe, Brian G Dalton, Amita A Desai, Susan W Sharp, Shawn D St Peter

Abstract readObservational Study
PubMed Publisher
In one paragraph

Observational study in Pediatric surgery international, 2016. 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, top 99% of its field
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, 7 citations in OpenAlex.

  1. Pooled it
  2. Article
  3. Ethics of randomized trials in pediatric surgery.Pediatric surgery international · 2020
    Review
  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

6 authors at 3 institutions in 1 country.

Katherine W GonzalezDepartment of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA.
Obinna O AdibeDepartment of Pediatric Surgery, Duke Children's Hospital and Health Center, DUMC 3815, Durham, NC, 27710, USA.
Brian G DaltonDepartment of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA.
Amita A DesaiDepartment of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA.
Susan W SharpDepartment of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA.
Shawn D St PeterDepartment of Pediatric Surgery, Children's Mercy Hospital, 2401 Gillham Rd, Kansas City, MO, 64108, USA. sspeter@cmh.edu.
Children's Mercy Hospital · USMercy Hospital · USDuke Children's Hospital & Health Center · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeThe success of prospective randomized trials relies on voluntary participation, which has been perceived as a barrier for successful trials in children who rely on parental permission. We sought to identify the reasons parents decline child participation to understand potential limitations in the consent process.

methodsA prospective observational study was conducted in 92 patients asked to participate in prospective randomized trials between 2012 and 2015. Parental reasons for refusal were documented.

resultsThe 92 refusals were distributed between studies investigating the management of circumcision, gastroschisis, pectus excavatum, appendicitis, pyloric stenosis, undescended testicles, abdominal abscess and gastroesophageal reflux. Reasons for refusal included preference of treatment path (37 %), inability to follow up (21 %), unspecified resistance to participate in research (18 %), preference to maintain independent surgeon decision (16 %), and desire for historically standard treatment (8 %). Of the families who opted to pursue a specific treatment arm rather than randomization, 35 % had prior experience with that treatment, 32 % had researched the procedure, 18 % wished to pursue the minimal intervention and 15 % did not specify.

conclusionsParental preference of therapy is the most common reason for refusal of study participation. This variable could be influenced with more effective explanation of study rationale and existing equipoise.

Indexed as

General SurgeryBiomedical ResearchComprehensionHumansParentsProspective StudiesRandomized Controlled Trials as TopicRefusal to ParticipateConsentParticipationPediatric researchRefusal

Identifiers

PMID26896964
OpenAlexW2287232766

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.