Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study
Abstract Background Patient 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 peopl...
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BMC
2025-07-01
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| Series: | Research Involvement and Engagement |
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| Online Access: | https://doi.org/10.1186/s40900-025-00751-x |
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| author | Ami Baba Maureen Smith Jennifer Preston Begonya Nafria Escalera Segolene Gaillard Pamela Dicks Matthew Prebeg Amanda Doherty-Kirby Kimberly Courtney Lynn Mendonza Tanya Chute Nagy Lotty Hooft Martin Offringa |
| author_facet | Ami Baba Maureen Smith Jennifer Preston Begonya Nafria Escalera Segolene Gaillard Pamela Dicks Matthew Prebeg Amanda Doherty-Kirby Kimberly Courtney Lynn Mendonza Tanya Chute Nagy Lotty Hooft Martin Offringa |
| author_sort | Ami Baba |
| collection | DOAJ |
| description | Abstract Background Patient 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. Conclusion With 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. |
| format | Article |
| id | doaj-art-c232c4ef2f704dfb894d191dbac68e87 |
| institution | Kabale University |
| issn | 2056-7529 |
| language | English |
| publishDate | 2025-07-01 |
| publisher | BMC |
| record_format | Article |
| series | Research Involvement and Engagement |
| spelling | doaj-art-c232c4ef2f704dfb894d191dbac68e872025-08-20T03:42:02ZengBMCResearch Involvement and Engagement2056-75292025-07-0111111410.1186/s40900-025-00751-xExperiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case studyAmi Baba0Maureen Smith1Jennifer Preston2Begonya Nafria Escalera3Segolene Gaillard4Pamela Dicks5Matthew Prebeg6Amanda Doherty-Kirby7Kimberly Courtney8Lynn Mendonza9Tanya Chute Nagy10Lotty Hooft11Martin Offringa12Child Health Evaluative Sciences, The Hospital for Sick Children Research InstituteINFORM RARE Research NetworkNational Institute for Health and Social Care Research (NIHR), Alder Hey Clinical Research FacilityInstitut de Recerca Sant Joan de DéuCIC Inserm, Kids France, CHU-LyonNHS NRS Children’s Research Network, Royal Aberdeen Children’s HospitalCentre for Addiction and Mental HealthSPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory GroupSPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory GroupSPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory GroupSPIRIT | CONSORT-Children and Adolescents Family Caregiver Advisory GroupCochrane Netherlands, Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht UniversityChild Health Evaluative Sciences, The Hospital for Sick Children Research InstituteAbstract Background Patient 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. Conclusion With 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.https://doi.org/10.1186/s40900-025-00751-xReporting guidelineClinical trialRandomised controlled trialPaediatricsChildrenAdolescents |
| spellingShingle | Ami Baba Maureen Smith Jennifer Preston Begonya Nafria Escalera Segolene Gaillard Pamela Dicks Matthew Prebeg Amanda Doherty-Kirby Kimberly Courtney Lynn Mendonza Tanya Chute Nagy Lotty Hooft Martin Offringa Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study Research Involvement and Engagement Reporting guideline Clinical trial Randomised controlled trial Paediatrics Children Adolescents |
| title | Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study |
| title_full | Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study |
| title_fullStr | Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study |
| title_full_unstemmed | Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study |
| title_short | Experiences, impact, and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials: a case study |
| title_sort | experiences impact and enablers of involving young people and family caregivers in developing reporting guidelines for paediatric randomised trials a case study |
| topic | Reporting guideline Clinical trial Randomised controlled trial Paediatrics Children Adolescents |
| url | https://doi.org/10.1186/s40900-025-00751-x |
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