Evidence map›Paper›PMID 39078826›Full record

Trial reportPloS one2024

A qualitative evaluation of treatment fidelity alongside a pilot trial of a novel therapy for pediatric Inflammatory Bowel Disease.

Jenny L Olson, Gisell Castillo, Amelia Palumbo, Megan Harrison, Ruth Singleton, Manoj M Lalu, Dean A Fergusson, Alain Stintzi, David R Mack, Justin Presseau

2 registry-linked trialsAbstract readRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in PloS one, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Not yet cited in PubMed.

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

NCT04520594 naactive not recruitingnot on this map

OptiMized REsistaNt Starch in Inflammatory Bowel Disease: The MEND Trial

TypeinterventionalSponsorChildren's Hospital of Eastern OntarioRan2021 to 2026Enrolled100ConditionsCrohn Disease, Ulcerative Colitis, Inflammatory Bowel DiseasesArmsResistant Starch, Placebo
NCT04522271 naactive not recruitingnot on this map

A Single Center, Randomized, Placebo-controlled, Double-blinded, Parallel, Pilot Clinical Trial to Assess Plant-derived Food-based Resistant Starches Individually Optimized for Patients With Crohn's Disease (CD) or Ulcerative Colitis (UC)

TypeinterventionalSponsorChildren's Hospital of Eastern OntarioRan2020 to 2026Enrolled80ConditionsCrohn Disease, Ulcerative Colitis, Inflammatory Bowel DiseasesArmsResistant Starch, Placebo
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

10 authors.

Jenny L OlsonMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.ORCID 0000-0003-2777-3794
Gisell CastilloMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Amelia PalumboMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Megan HarrisonDepartment of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.
Ruth SingletonChildren's Hospital of Eastern Ontario Research Institute, Ottawa, Ontario, Canada.
Manoj M LaluMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Dean A FergussonMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.
Alain StintziDepartment of Biochemistry, Microbiology and Immunology, University of Ottawa, Ottawa, Ontario, Canada.
David R MackDepartment of Pediatrics, University of Ottawa, Ottawa, Ontario, Canada.
Justin PresseauMethodological and Implementation Research Program, Ottawa Hospital Research Institute, Ottawa, Ontario, Canada.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundProcess evaluations conducted alongside clinical trials can improve understanding of treatment fidelity and provide contextual knowledge to aide interpretations of trial outcomes. We adopted a multiple-goals perspective to investigate treatment fidelity in two related pilot clinical trials of an adjuvant treatment for pediatric-onset Inflammatory Bowel Disease. This included a focus on barriers and enablers of performing trial-specific activities and of integrating those activities into daily life.

methodsWe conducted one-time semi-structured interviews with a sub-sample of participants of the Resistant Starch in Pediatric Inflammatory Bowel Disease (NCT04522271) and Optimized Resistant Starch in Inflammatory Bowel Disease pilot trials (NCT04520594) and their caregivers (N = 42). The trials examined the effects of personalized food-derived resistant starches as an adjuvant therapy on intestinal microbiome functioning. Interviews were conducted within 3-months of participants completing or withdrawing from the trials. Interview guides with age-appropriate language were developed and pilot tested. Codes were identified inductively though conventional content analysis and then mapped to personal projects analysis, to explore how participants navigated between activities.

resultsThree themes were identified. The first described the potential impact of living with inflammatory bowel disease and taking prescribed medications. The second described characteristics of trial-specific activities that might impact on their enactment, including perceived difficulty, and challenges following procedures or using trial materials. The third described the integration of trial-specific activities with school, work, household demands, and social, and extracurricular activities.

conclusionsAdjusting to living with inflammatory bowel disease and managing its treatment can impact trial participation. Integrating trial-related activities into daily life can be challenging, which could heighten perceptions of goal conflict. Findings can inform interpretations of trial outcomes and development of strategies for trial optimization and implementation of the adjuvant therapy into clinical practice.

Indexed as

Inflammatory Bowel DiseasesAdolescentCaregiversChildFemaleGastrointestinal MicrobiomeHumansMalePilot ProjectsQualitative ResearchStarchStarch

Identifiers

PMID39078826
PMCPMC11288461

What OpenQuestion holds

Textmetadata
LicenceCC BY
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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.