Evidence map›Paper›PMID 31538130›Full record

ArticleContemporary clinical trials communications2019

Shared decision making in IBD: A novel approach to trial consent and timing.

Christine L Schuler, Cassandra Dodds, Kevin A Hommel, Richard F Ittenbach, Lee A Denson, Ellen A Lipstein

Registry-linked trialOpen access · goldAbstract read
In one paragraph

Article in Contemporary clinical trials communications, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05689892 (Impact of a Shared Decision Making Intervention in Paediatric Inflammatory Bowel Disease Therapeutic Decision-making), which is not on this map. Cited by 5 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed, 1 pooled it
1.9field-weighted citation impact, top 12% 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.

NCT05689892 naunknown statusnot on this mapstarted 2024, after this paper: background citation

Impact of a Shared Decision Making Intervention in Paediatric Inflammatory Bowel Disease Therapeutic Decision-making

TypeinterventionalSponsorLondon Health Sciences CentreRan2024 to 2025Enrolled150ConditionsInflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, IBDArmsDecision Coach Sessions
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 1 synthesis or guideline pooled it, 7 citations in OpenAlex.

  1. Pooled it
  2. Pilot trial of iBDecide: Evaluating an online tool to facilitate shared decision making for adolescents and young adults with ulcerative colitis.Health expectations : an international journal of public participation in health care and health policy · 2022
    Trial
  3. Article
  4. Article
  5. Review
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 2 institutions in 1 country.

Christine L SchulerDivision of Hospital Medicine, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Cassandra DoddsJames M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Kevin A HommelDivision of Behavioral Medicine and Clinical Psychology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Richard F IttenbachDivision of Biostatistics and Epidemiology, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Lee A DensonDivision of Gastroenterology, Hepatology and Nutrition, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Ellen A LipsteinJames M. Anderson Center for Health Systems Excellence, Cincinnati Children's Hospital Medical Center, Cincinnati, OH, USA.
Cincinnati Children's Hospital Medical Center · USUniversity of Cincinnati Medical Center · US

Funding

Stem Cell/Organoid and Genome Editing CoreP30DK078392 · NIDDK · CINCINNATI CHILDRENS HOSP MED CTR · PI Alexander Miethke · 2007 to 2026
$24.4M
NIDDK NIH HHS P30 DK078392
6 · The paper itself

Abstract

backgroundShared decision making (SDM) between families and physicians may facilitate informed, timely decisions to proceed with biologic therapy in children with inflammatory bowel disease (IBD). Our team previously developed an SDM tool to aid communication between physicians and families when considering biologic therapy for children with IBD.

objectiveWe are conducting a prospective, pre-post pilot trial of a new SDM tool. The primary aim of the study is to assess feasibility of both the intervention and trial procedures for a future large-scale trial.

methodsWe are enrolling physicians with experience prescribing biologic therapy in the past year and families of children with IBD. Families in the intervention arm receive a 3-step intervention including a letter sent before trial consent or clinic appointment, an in-clinic decision tool and a follow-up phone call. Our primary trial outcome is a measure of feasibility, with measures of clinical and decision outcomes secondary. We seek to enroll 27 families in each of 2 arms (usual-care and intervention) and plan data collection at the time of the initial visit or hospital stay, and at 1 week, 3 months, and 6 months after the initial visit.

conclusionThis study protocol is designed to demonstrate that integrating novel consent procedures, including timing and multiple versions of written consent, may increase trial feasibility while maintaining scientific rigor and full protection of study participants.

Indexed as

ConsentInflammatory bowel diseasePediatricsPilot trials

Identifiers

PMID31538130
PMCPMC6745512
OpenAlexW2971738010

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
Read underepoch 390

Registered trials

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.