Evidence map›Paper›PMID 41338635›Full record

ArticleBMJ open2025

Patient and Public Involvement in randomised controlled trials in general and abdominal SURGery: a protocol for the PPISurg systematic review.

Till Seiboldt, Magdalena Holze, Eva Kalkum, Maximilian Joos, Daniela Merz, Johannes A Vey, Sinclair Awounvo, Solveig Tenckhoff, Rosa Klotz

Abstract read
In one paragraph

Article in BMJ open, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the 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.

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

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

9 authors.

Till SeiboldtDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, BW, Germany.ORCID http://orcid.org/0009-0001-0267-563X
Magdalena HolzeDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, BW, Germany.ORCID http://orcid.org/0009-0004-3771-6245
Eva KalkumStudy Center of the German Society of Surgery (SDGC), University Hospital Heidelberg, Heidelberg, Germany.
Maximilian JoosDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, BW, Germany.
Daniela MerzDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, BW, Germany.
Johannes A VeyInstitute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.
Sinclair AwounvoInstitute of Medical Biometry, University of Heidelberg, Heidelberg, Germany.
Solveig TenckhoffStudy Center of the German Society of Surgery (SDGC), University Hospital Heidelberg, Heidelberg, Germany.
Rosa KlotzDepartment of General, Visceral and Transplantation Surgery, University Hospital Heidelberg, Heidelberg, BW, Germany rosa.klotz@med.uni-heidelberg.de.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionRandomised controlled trials (RCTs) are central to generating high-quality evidence in the surgical field but face unique methodological and practical challenges, including recruitment, follow-up, blinding and ensuring patient-centred outcomes. Patient and public involvement (PPI) has emerged as a promising strategy to enhance the relevance, quality and impact of surgical research by actively involving patients throughout the whole research process. Despite growing recognition of its value, the integration and reporting of PPI in surgical RCTs remain inconsistent, and no systematic evaluation has yet addressed its application within general and abdominal surgery. METHODS AND ANALYSIS: RCTs in general and abdominal surgery published since 2014 will be identified through systematic searches of the databases MEDLINE, Web of Science and CENTRAL. This systematic review and primary (meta-epidemiological) statistical analysis will assess the reporting prevalence, implementation extent and quality of PPI over time. The Guidance for Reporting Involvement of Patients and the Public 2 (GRIPP2)-SF checklist and Cochrane Risk of Bias V.2.0 tool will be used to evaluate PPI reporting and study quality. To enable a comparison between studies reporting PPI and those that do not, propensity score matching will be performed to identify non-PPI studies with similar population and design characteristics. Subsequently, regression analyses will be employed to investigate potential associations between PPI reporting and various trial characteristics, including patient recruitment and retention, outcome selection and methodological quality. The Patient Advisory Board of the Study Centre of the German Society of Surgery is actively engaged in all phases of the systematic review. ETHICS AND DISSEMINATION: This systematic review does not require ethical approval. Results will be published in an international peer-reviewed scientific journal, as well as distributed in a lay format to the patient community and to the broader public. PROSPERO REGISTRATION NUMBER: CRD42024524426.

Indexed as

AbdomenCommunity ParticipationGeneral SurgeryPatient ParticipationSurgical Procedures, OperativeHumansRandomized Controlled Trials as TopicResearch DesignSystematic Reviews as Topicpatient and public involvementpatient centered researchrandomized controlled trialSurgery

Identifiers

PMID41338635
PMCPMC12682185

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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.