{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T23:35:02Z","timestamp":1791502502817,"version":"4.3.4"},"reference-count":44,"publisher":"Royal College of Surgeons of England","issue":"5","content-domain":{"domain":[],"crossmark-restriction":false},"short-container-title":["annals"],"published-print":{"date-parts":[[2025,5]]},"abstract":"<jats:sec><jats:title>Introduction<\/jats:title><jats:p> Consent 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. <\/jats:p><\/jats:sec><jats:sec><jats:title>Methods<\/jats:title><jats:p> This 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 \u2018RoB 2\u2019 and \u2018ROBINS-I\u2019. Meta-analysis was not possible because of the results\u2019 heterogeneity. <\/jats:p><\/jats:sec><jats:sec><jats:title>Findings<\/jats:title><jats:p> We identified 21 studies investigating PSCF with no systematic reviews and meta-analyses reported. Most studies were quality improvement projects (n = 10) followed by randomised studies (n = 5). No definitive legal guidance for PSCFs and no studies assessing their role in litigation post-procedural complications were identified. PSCFs were associated with improved documentation (70%\u2013100%; n = 11) and legibility (100%; n = 2) compared with GCF. Randomised studies (n = 4) investigating patient understanding and recall for PSCF were inconclusive compared with GCF. <\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p> The 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. <\/jats:p><\/jats:sec>","DOI":"10.1308\/rcsann.2024.0079","type":"journal-article","created":{"date-parts":[[2024,10,3]],"date-time":"2024-10-03T13:37:58Z","timestamp":1727962678000},"page":"354-363","source":"Crossref","is-referenced-by-count":4,"title":["Role of procedure-specific consent forms in clinical practice: a systematic review"],"prefix":"10.1308","volume":"107","author":[{"given":"J","family":"Norvill","sequence":"first","affiliation":[{"name":"Royal Chesterfield Hospital NHS Foundation Trust","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C","family":"Bent","sequence":"additional","affiliation":[{"name":"East Sussex Healthcare NHS Trust","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"JA","family":"Mawhinney","sequence":"additional","affiliation":[{"name":"The Pulvertaft Hand Centre, University Hospitals of Derby and Burton NHS Foundation Trust","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"N","family":"Johnson","sequence":"additional","affiliation":[{"name":"The Pulvertaft Hand Centre, University Hospitals of Derby and Burton NHS Foundation Trust","place":["UK"]}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"171","reference":[{"key":"C1","unstructured":"Royal College of Surgeons. Consent: supported decision-making: a guide to good practice 2022. https:\/\/www.rcseng.ac.uk\/standards-and-research\/standards-and-guidance\/good-practice-guides\/consent\/ (cited November 2023)."},{"key":"C2","unstructured":"General Medical Council. Decision making and consent London 2020. https:\/\/www.gmc-uk.org\/ethical-guidance\/ethical-guidance-for-doctors\/decision-making-and-consent (cited November 2023)."},{"key":"C3","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2020.05.017"},{"key":"C4","unstructured":"Baroness Julia Cumberlege. First do no harm-the report of the IMMDS Review 2020. https:\/\/www.immdsreview.org.uk\/downloads\/IMMDSReview_Web.pdf (cited November 2023)."},{"key":"C5","unstructured":"Department of Health. Reference guide to consent for examination or treatment (second edition). https:\/\/www.gov.uk\/government\/publications\/reference-guide-to-consent-for-examination-or-treatment-second-edition (cited November 2023)."},{"key":"C6","doi-asserted-by":"publisher","DOI":"10.1136\/jme.2010.039644"},{"key":"C7","doi-asserted-by":"publisher","DOI":"10.1016\/j.surge.2015.11.004"},{"key":"C8","doi-asserted-by":"publisher","DOI":"10.1016\/j.bjps.2016.11.015"},{"key":"C9","doi-asserted-by":"publisher","DOI":"10.1308\/rcsann.2018.0099"},{"key":"C10","doi-asserted-by":"publisher","DOI":"10.1046\/j.1365-2168.2000.01562.x"},{"key":"C11","doi-asserted-by":"publisher","DOI":"10.1016\/j.surge.2020.06.004"},{"key":"C12","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.n71"},{"key":"C13","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.l4898"},{"key":"C14","doi-asserted-by":"publisher","DOI":"10.1136\/bmj.i4919"},{"key":"C16","doi-asserted-by":"publisher","DOI":"10.1016\/j.juro.2006.03.037"},{"key":"C17","doi-asserted-by":"publisher","DOI":"10.1016\/j.jpeds.2008.12.022"},{"key":"C18","doi-asserted-by":"publisher","DOI":"10.12968\/hmed.2013.74.4.224"},{"key":"C19","doi-asserted-by":"publisher","DOI":"10.1111\/ans.13888"},{"key":"C20","doi-asserted-by":"publisher","DOI":"10.1136\/bmjquality.u211571.w4730"},{"key":"C21","doi-asserted-by":"publisher","DOI":"10.1016\/j.amsu.2018.09.033"},{"key":"C22","doi-asserted-by":"publisher","DOI":"10.12968\/hmed.2018.79.2.97"},{"key":"C23","doi-asserted-by":"publisher","DOI":"10.1177\/1465312518815547"},{"key":"C24","doi-asserted-by":"publisher","DOI":"10.1186\/s13037-020-00252-8"},{"key":"C25","doi-asserted-by":"publisher","DOI":"10.1308\/003588409X359277"},{"key":"C26","doi-asserted-by":"publisher","DOI":"10.1308\/003588410X12628812458257"},{"key":"C27","doi-asserted-by":"publisher","DOI":"10.1016\/j.amjsurg.2012.07.020"},{"key":"C28","doi-asserted-by":"publisher","DOI":"10.1142\/S021881041350010X"},{"key":"C29","doi-asserted-by":"publisher","DOI":"10.15761\/HEC.1000105"},{"key":"C30","doi-asserted-by":"publisher","DOI":"10.1136\/bmjoq-2020-001264"},{"key":"C31","doi-asserted-by":"publisher","DOI":"10.1016\/0952-8180(91)90199-W"},{"key":"C32","doi-asserted-by":"publisher","DOI":"10.1097\/PTS.0000000000000412"},{"key":"C33","doi-asserted-by":"publisher","DOI":"10.1097\/PTS.0000000000000756"},{"key":"C34","doi-asserted-by":"publisher","DOI":"10.1016\/j.jss.2015.03.058"},{"key":"C35","doi-asserted-by":"publisher","DOI":"10.1097\/PTS.0000000000000310"},{"key":"C36","unstructured":"Queen Victoria Hospital NHS Foundation Trust. Policy for consent to examination or treatment. https:\/\/www.qvh.nhs.uk\/wp-content\/uploads\/2021\/11\/Consent-to-Examination-or-Treatment-Policy.pdf#:\u223c:text = Patients%20may%2C%20if%20they%20wish,for%20all%20surgery%2Fsurgical%20procedures (cited November 2023)."},{"key":"C37","unstructured":"University Hospitals Bristol NHS Foundation Trust. Policy for consent to examination or treatment https:\/\/www.uhbristol.nhs.uk\/media\/3122849\/17-591_-_foi_response_-_attachment.pdf (cited November 2023)."},{"key":"C38","unstructured":"University Hospitals Plymouth NHS Trust. Consent to examination or treatment. https:\/\/www.plymouthhospitals.nhs.uk\/download.cfm?doc = docm93jijm4n2739 (cited November 2023)."},{"key":"C39","unstructured":"NHS Lothian. Guidance for obtaining consent for treatment\/procedure\/investigation. https:\/\/policyonline.nhslothian.scot\/wp-content\/uploads\/2023\/03\/Consent%20Guidance%20for%20staff.pdf (cited November 2023)."},{"key":"C40","unstructured":"NHS Wales. Model policy for consent to examination or treatment.https:\/\/nwssp.nhs.wales\/ourservices\/welsh-risk-pool\/welsh-risk-pool-documents\/model-policy-for-consent-to-examination-or-treatment\/ (cited November 2023)."},{"key":"C41","doi-asserted-by":"publisher","DOI":"10.1016\/j.surge.2022.05.004"},{"key":"C42","doi-asserted-by":"publisher","DOI":"10.1093\/bjs\/znaa119"},{"key":"C43","doi-asserted-by":"publisher","DOI":"10.1093\/bjs\/znac285"},{"key":"C44","doi-asserted-by":"publisher","DOI":"10.1016\/j.pec.2009.09.034"},{"key":"C45","doi-asserted-by":"publisher","DOI":"10.1111\/hex.12588"}],"container-title":["The Annals of The Royal College of Surgeons of England"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/publishing.rcseng.ac.uk\/doi\/pdf\/10.1308\/rcsann.2024.0079","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,5,6]],"date-time":"2025-05-06T14:44:23Z","timestamp":1746542663000},"score":1,"resource":{"primary":{"URL":"https:\/\/publishing.rcseng.ac.uk\/doi\/10.1308\/rcsann.2024.0079"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,5]]},"references-count":44,"journal-issue":{"issue":"5","published-print":{"date-parts":[[2025,5]]}},"alternative-id":["10.1308\/rcsann.2024.0079"],"URL":"https:\/\/doi.org\/10.1308\/rcsann.2024.0079","relation":{},"ISSN":["0035-8843","1478-7083"],"issn-type":[{"value":"0035-8843","type":"print"},{"value":"1478-7083","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,5]]}}}