Evidence map›Paper›PMID 39360925›Full record

SynthesisAnnals of the Royal College of Surgeons of England2025

Role of procedure-specific consent forms in clinical practice: a systematic review.

J Norvill, C Bent, J A Mawhinney, N Johnson

Abstract readSystematic Review
In one paragraph

Synthesis in Annals of the Royal College of Surgeons of England, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing 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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. Nothing in life is to be feared; it is only to be understood.Advances in ophthalmology practice and research
    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

4 authors.

J NorvillRoyal Chesterfield Hospital NHS Foundation Trust, UK.
C BentEast Sussex Healthcare NHS Trust, UK.
J A MawhinneyThe Pulvertaft Hand Centre, University Hospitals of Derby and Burton NHS Foundation Trust, UK.
N JohnsonThe Pulvertaft Hand Centre, University Hospitals of Derby and Burton NHS Foundation Trust, UK.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionConsent forms play an active role in the consent process with generic, handwritten consent forms (GCF) often the standard across the National Health Service. Increasingly, procedure-specific consent forms (PSCF) are being used as an alternative. However, concerns remain about whether they meet the standard for consent. We therefore conducted a systematic review with the objectives of investigating evidence for PSCF, study methodology and medicolegal criteria.

methodsThis systematic review was prospectively registered on PROSPERO (CRD42023392693) and conducted from 1 January 1990 to 17 March 2023 using the MEDLINE, Embase, CINAHL, CENTRAL and Emcare databases. A grey literature search was also performed. All studies evaluating PSCF in medical and surgical settings were included. Risk-of-bias analysis was performed using 'RoB 2' and 'ROBINS-I'. Meta-analysis was not possible because of the results' heterogeneity.

findingsWe identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (

conclusionsThe heterogeneous evidence available merely demonstrates superior documentation of PSCF compared with GCF. Studies do not adequately investigate the impact on informed consent and fail to address the associated legal concerns. Further randomised studies with patient-centric outcomes and consideration for medicolegal criteria are needed.

Indexed as

Consent FormsInformed ConsentSurgical Procedures, OperativeHumansConsent formInformed consentInformed consent documentProcedure-specific consent forms

Identifiers

PMID39360925
PMCPMC12043358

What OpenQuestion holds

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Registered trials

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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.