Evidence map›Paper›PMID 40598557›Full record

ArticleResearch involvement and engagement2025

Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study.

Ami Baba, Maureen Smith, Jennifer Preston, Begonya Nafria Escalera, Segolene Gaillard, Pamela Dicks, Matthew Prebeg, Amanda Doherty-Kirby, Kimberly Courtney, Lynn Mendonza and 3 more

Abstract readLetter
PubMed Full text at PMC Publisher
In one paragraph

Article in Research involvement and engagement, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing 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

1 citing paper in PubMed.

  1. 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

13 authors.

Ami BabaChild Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada.
Maureen SmithINFORM RARE Research Network, Ottawa, ON, Canada.
Jennifer PrestonNational Institute for Health and Social Care Research (NIHR), Alder Hey Clinical Research Facility, Liverpool, UK.
Begonya Nafria EscaleraInstitut de Recerca Sant Joan de Déu, Barcelona, Spain.
Segolene GaillardCIC Inserm, Kids France, CHU-Lyon, Lyon, Bron, 1407, 69677, France.
Pamela DicksNHS NRS Children's Research Network, Royal Aberdeen Children's Hospital, Aberdeen, Scotland, UK.
Matthew PrebegCentre for Addiction and Mental Health, Toronto, ON, Canada.
Amanda Doherty-KirbySPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada.
Kimberly CourtneySPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada.
Lynn MendonzaSPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada.
Tanya Chute NagySPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory Group, Toronto, ON, Canada.
Lotty HooftCochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht University, Utrecht, The Netherlands.
Martin OffringaChild Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, ON, Canada. martin.offringa@sickkids.ca.

Funding

CIHR CIHR - KRS 329021Strategy for Patient-Oriented Research MYG - 171,684
6 · The paper itself

Abstract

backgroundPatient and public involvement (PPI) is increasingly recognized as important, yet no guidance exists on integrating young people and family caregiver perspectives in the development of research reporting guidelines. We developed two paediatric-specific extensions with young people (ages 10-24 years) and family caregivers (YPFC) for the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) and Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines: SPIRIT-Children and Adolescents 2025 (SPIRIT-C) and CONSORT-Children and Adolescents 2025 (CONSORT-C). This case study describes how we involved YPFC in the development of SPIRIT-C and CONSORT-C and identified enablers of impactful PPI. MAIN TEXT: We formed a Youth Advisory Group (ages 13-19 years) and a Family Caregiver Advisory Group. A miniseries of two Young Person Reporting Guideline workshops aimed at generating randomised controlled trials (RCT) reporting items were conducted virtually in Canada, England, France, Scotland, and Spain, engaging 42 young people (ages 10-21 years). Young people (ages 19-24 years) and family caregivers participated as panellists in an international Delphi study. Family caregiver advisors actively contributed to the Consensus Meeting and to the writing process of the guidelines' Explanation and Elaboration (E&E) documents. After each project stage, YPFC feedback was collected. PPI impact was defined as tangible changes, learnings, and outcomes, both positive and negative, to the guideline development process and the final guidelines resulting from YPFC co-development. YPFC found their involvement in the project a valuable experience. Their contributions to key project stages, such as the Delphi study, Consensus Meeting, and the development of the E&E documents impacted the final guidelines and E&E documents, with the inclusion of four new youth generated reporting items. Feedback throughout the project informed six "enablers" for productive partnerships in reporting guideline development: (1) designated point person, (2) tailored training, (3) access to project materials, (4) clear expectations on time commitment and compensation, (5) structured check-in sessions, and (6) demonstrated openness to feedback.

conclusionWith careful preparation, investing in impactful PPI enablers, YPFC can meaningfully contribute to the development of research reporting guidelines, improve final deliverables, and ultimately shape research that reflects their perspectives.

Indexed as

AdolescentsChildrenClinical trialFamily involvementPaediatricsPatient and public involvementRandomised controlled trialReporting guidelineYouth involvement

Identifiers

PMID40598557
PMCPMC12211127

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.