Evidence map›Paper›PMID 40611321›Full record

ArticleResearch involvement and engagement2025

Patient and public involvement in randomised controlled trial design and implementation: a process evaluation of the linking you to support and advice (LYSA) trial.

Katarina Medved, Katie Johnston, Sasna S Thomas, Josephine Hegarty, Gillian Casey, Roisin M Connolly, Laia Raigal, Kate O'Connell

Registry-linked trialAbstract read
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. It is linked to trial NCT05035173 (Women's Cancer Survivorship), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing 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.

NCT05035173 nacompletednot on this map

Women's Cancer Survivorship: The LYSA (Linking You to Support and Advice) Trial

TypeinterventionalSponsorUniversity College CorkRan2021 to 2026Enrolled200ConditionsSurvivorship, Breast Cancer, Cervical Cancer, Endometrial CancerArmsSurvivorship Clinic Assessments, Survivorship Clinic Nurse Resource, Survivorship Clinic Dietitian Resource
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. 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

8 authors.

Katarina MedvedCancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland. kmedved@ucc.ie.
Katie JohnstonCUH/UCC Cancer Centre, Cork University Hospital, Cork, Ireland.
Sasna S ThomasCancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland.
Josephine HegartyCatherine McAuley School of Nursing and Midwifery, University College Cork, Cork, Ireland.
Gillian CaseyCancer Research @UCC PPI Panel Contributor, Cork, Ireland.
Roisin M ConnollyCancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland.
Laia Raigal *Cancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland.
Kate O'Connell *Cancer Research @UCC, College of Medicine and Health, University College Cork, Cork, Ireland.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe implementation of Patient and Public Involvement (PPI) in randomised controlled clinical trials (RCT) is crucial for improving the relevance and quality of research. PPI entails active engagement of patients and the public in various stages of the research process. The processes for effectively implementing PPI in RCTs remain underexplored and heterogeneous.

methodsAn explorative single case study of the Linking You to Support and Advice (LYSA) randomised controlled trial, NCT05035173, aims to evaluate the processes of implementation of PPI through different stages of the research cycle.

resultsThe development and review of the grant application resulted in a more patient focused study development. Furthermore, the review of surveys, questionnaires and patient facing study materials led to amendments mainly referring to the language used. PPI contributors helped to co-design the symptom management resources in partnership with the project team. Evaluation of the ePRO collection tool did not result in any further amendments. PPI contributors participated in the development of the study’s acronym and focus group discussion. As a direct result of PPI input further work and research was done in the area of metastatic breast cancer. PPI contributors participated in social media work, review and co-authorship of this paper.

conclusionsImplementation of PPI through different stages of RCT’s is effective. It highlighted the importance of PPI in improving the relevance and quality of research. While PPI offers numerous benefits, its implementation is not without challenges. Barriers such as resource and time constraints, and varying levels of stakeholder engagement pose a challenge to effective PPI integration.

Identifiers

PMID40611321
PMCPMC12231285

What OpenQuestion holds

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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.