Pre-designed consent forms for total hip replacement, total knee replacement, and caesarean section: A national observational study of current English practice Alexander Light * , Tanya Gupta, Madura Nandakumar, Maria Dadabhoy, Abigail Burrows, Allen Daniel, Sandeep Karthikeyan GKT School of Medical Education, King's College London, Guy's Campus, St. Thomas Street, London, SE1 1UL, United Kingdom article info Article history: Received 7 April 2018 Received in revised form 5 June 2018 Accepted 14 June 2018 Available online xxx Keywords: Surgery Consent Consent forms Orthopaedics Obstetrics Total hip replacement Total knee replacement Caesarean section abstract Background: Pre-designed procedure-specific consent forms (PCFs) have potential advan- tages over handwritten forms for improving the consent process and disclosing material risks, as necessitated by the 2015 ‘Montgomery’ ruling. We aimed to assess the use and quality of English NHS Trust PCFs for total hip replacement (THR), total knee replacement (TKR), and caesarean section (CS). Methods: All 233 English NHS Trusts were sent a Freedom of Information request seeking PCFs for these operations. Listed risks, and whether their incidence was quoted, were compared against those listed in published PCFs from the British Orthopaedic Association (BOA) and the Royal College of Obstetricians and Gynaecologists (RCOG). Results: 203/233 (87.1%) Trusts responded, contributing 17 THR PCFs, 15 TKR PCFs, and 33 CS PCFs. Overall, the type of risks listed for each operation was highly variable. 5.9% of THR PCFs contained all 18 BOA-quoted risks. No TKR PCF contained all 19 BOA-quoted risks. 24.2% of CS PCFs contained all 17 RCOG-quoted risks. For each operation, few PCFs listed incidences for quoted-risks. Conclusions: Very few Trusts use PCFs for these common operations. When PCFs are used, the reporting of risks and their likelihood is variable and insufficient. BOA- and RCOG- approved PCFs are high quality and influential on Trust-PCF design but still omit impor- tant risks. We fear PCFs analysed here do not sufficiently improve the consent process compared to handwritten forms. PCFs have potential to improve the quality of consent, however they need greater uptake and to be of greater quality. © 2018 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved. Introduction Informed consent for a surgical procedure requires a thor- ough, shared discussion between surgeon and patient of the intended benefits and possible risks of that procedure. In 2015, following Montgomery vs. Lanarkshire Health Board, the UK Supreme Court ruled that a doctor must take ‘reasonable care to ensure that the patient is aware of any material risks involved in any recommended treatment, and of any reasonable alternative or variant treatments’. 1 Material risk was defined as ‘a risk to which a reasonable person in the patient's position would be likely to attach significance or a risk that a doctor knows e or should reasonably know e would probably be deemed of significance by this particular patient’ 2 . A consent form provides a framework for discussion * Corresponding author. E-mail addresses: alexander.light@kcl.ac.uk (A. Light), tanya.gupta@kcl.ac.uk (T. Gupta), madura.nandakumar@kcl.ac.uk (M. Nandakumar), maria.dadabhoy@kcl.ac.uk (M. Dadabhoy), abigail.burrows@kcl.ac.uk (A. Burrows), allen.daniel@kcl.ac.uk (A. Daniel), sandeep.karthikeyan@kcl.ac.uk (S. Karthikeyan). the surgeon xxx (2018) 1 e8 Please cite this article in press as: Light A, et al., Pre-designed consent forms for total hip replacement, total knee replacement, and caesarean section: A national observational study of current English practice, The Surgeon (2018), https://doi.org/10.1016/ j.surge.2018.06.001 https://doi.org/10.1016/j.surge.2018.06.001 1479-666X/© 2018 Royal College of Surgeons of Edinburgh (Scottish charity number SC005317) and Royal College of Surgeons in Ireland. Published by Elsevier Ltd. All rights reserved.