Regional Audit: Valid and Informed Consent for Lower Limb Arthroplasty in Orthopaedic Surgery: Are We Doing Enough?
Z Sohail, R Mills, O Adebayo, G Mamarelis, F Acquaah, S Subhash, I Liew
British Journal of Surgery, 19 August 2022; 109(Supplement 6)
Abstract
Aim
To investigate regionally the validity of the patient consent process for lower limb arthroplasty, compared to set data standards, with a view to investigating whether the consent process could be improved, and if so, how?
Method
Regional data from 8 hospital trusts (50 data sets collected from each hospital) across England was collected retrospectively from May 1st, 2021, (25 THR, 25 TKR), collated and collectively analysed against agreed, pre-determined set criterion. Data standards included ascertaining whether alternatives to surgery were offered and exploring the likely benefits and risks. Capacity to consent for procedure-specific surgery was measured as patients’ ability to understand, weigh up, retain, and communicate their decisions regarding surgery. Hospitals regional data was collectively analysed.
Results
Capacity was only successfully fulfilled and documented regionally in 11.6% of hip and 13.9% of knee replacement surgeries, despite Consent Form 1 having been filled out in 94.8% and 88.5% of cases respectively, which were procedure specific in only 74.0% and 72.1% of cases.
Conclusions
Significant improvement can clearly be made to an area of already such high clinical negligence claims. We propose a novel solution involving the digitalisation of the consent process, including multimedia surgical videos to better inform patients and reliably assist in establishing the validity of a patient’s consent. The implications of this are limited not only to Orthopaedic surgery but could have far-reaching consequences across all surgical (and indeed medical) specialties, where obtaining valid and informed consent for procedures remains integral to quality patient care.

Standardizing Consent Forms for Outpatient Urology Procedures
S Shrestha, E Jiang, A Sandhu, P Pinnamaraju, T Swallow, A Pai
British Journal of Surgery, 19 August 2022; 109(Supplement 6)
Abstract
Introduction
British Association of Urological Surgeons (BAUS) guidelines have provided comprehensive and standardized guidelines for urological procedures, including indications, benefits, risks involved, and alternatives. At our institution, currently, consent forms are handwritten resulting in generalized or incomplete information given to patients.
Aim
To improve patient understanding of the procedures they are undergoing by providing standardized consent form stickers for procedures as per BAUS guidelines.
Method
Single institution data were collected retrospectively for flexible cystoscopy, stent removal, transrectal ultrasonography (TRUS), and transurethral laser ablation (TULA). Consent forms compared to BAUS guidelines. A standardized consent form sticker for each procedure was developed in accordance with BAUS guidelines and reviewed via the trust’s clinical governance process. Clinicians were educated in their use for future consenting.
Results
Consent forms of consecutive patients over a two-month period were analyzed. The initial audit showed that the proportion of patients who had all risks included was 0% for flexible cystoscopy, 0% for TRUS, and 100% for stent removal. Common and rare, but serious risks were not mentioned in all cases. 100% of patients had all risks mentioned for TULA. After education on the consent process and the introduction of consent form stickers, all risks (100%) were mentioned for all procedures.
Conclusions
It is imperative that patients are fully informed about the risks, indications, and alternatives of their treatment. Failure to provide this information in full may lead to unnecessary angst, morbidity, and litigation. Simple quality improvement projects can lead to measurable improvement in patient information.

Improving Consent Forms for Laparoscopic Cholecystectomy; a Visual Consent Form Toolkit
M Jeilani, J Super, M Riad, B Jayasankar
British Journal of Surgery, 19 August 2022; 109(Supplement 6)
Abstract
Aim
Laparoscopic cholecystectomy is a common elective operation with significant complication risks. GMC guidance on consent emphasises informed consent, and failure to warn patients of significant complications can lead to medico-legal implications. We aimed to assess the quality of risk documentation for laparoscopic cholecystectomies performed at our trust. In particular, we aimed to assess improvement since previous cycles after circulation of our boutique ‘Visual Consent Form Toolkit’, an easily accessible resource for risks associated with common procedures.
Method
Consent forms for 49 elective laparoscopic cholecystectomies performed at a busy district general hospital between September and November 2021 were retrospectively analysed. Risk documentation was audited against a standard of 15 common complications associated with laparoscopic cholecystectomy.
Results
There was significant improvement across the board. Risks previously documented at 100% remained at this level (infection & bleeding). Those previously well-documented showed further improvement (CBD injury, bile leak, damage to local structures, open conversion & VTE). Of those not previously well-documented (the rest), all except two (diarrhoea & pancreatitis) showed improvement. In particular anaesthetic risks, which was emphasised in our toolkit, saw the largest improvement.
Conclusions
Risk documentation on consent forms has overall considerably improved with the circulation of our ‘Visual Consent Form Toolkit’. More risks now fully or partially meet the expected standard. From those risks not meeting the expected standard despite numerous audit cycles, we understand that surgeons do not feel these risks should be documented in all situations for all patients, and therefore that an expected standard does not necessarily apply for these risks.

Improving the Quality of Consent Forms in Emergency Laparotomy
S Probert, N Ballanamada Appaiah, L Khan
British Journal of Surgery, 19 August 2022; 109(Supplement 6)
Abstract
Aim
To improve the quality and completion of consent forms for patients undergoing emergency laparotomy.
Methods
A standard for emergency laparotomy consent forms, guided by recommendations from the National Emergency Laparotomy Audit (NELA) was established. This standard was used to score consent forms. Our initial audit of 20 consent forms scored an average of 41.9%. A template sticker, specific to emergency laparotomy, was created. This contains all of the information deemed important by our standard. The sticker allows the surgeon completing the consent process to simply tick off the individual components once discussed with the patient and apply it to the regular consent form. The stickers were introduced to all of those involved in consenting patients, and their use was strongly encouraged.
Results
Consent forms were collected and scored over the following 2-months. Of the 18 consent forms, 33% made use of the consent form sticker, with an average score of 65.2% (improvement of 23.3%). In analysing scores for both the pre- and post-intervention consent forms, we found a P value of < 0.0001.
Conclusions
The use of consent templates specific to surgical procedures improves the quality of consent forms and ensures that all possible complications are discussed with patients. The use of stickers for emergency laparotomy has improved the quality of our consent forms. With ongoing use, we aim to ensure that all patients undergoing this procedure are adequately consented. There remains room for continued improvement, and we believe ongoing exposure to these stickers will lead to an up-take in use.

Patients’ views on laparoscopic cholecystectomy consent process: Consent in clinic improves quality of informed consent and patient satisfaction
Peiming Yang
British Journal of Surgery, 9 August 2022; 109(Supplement 5)
Abstract
Aims
Informed consent for elective laparoscopic cholecystectomy should begin at first clinic consultation. Due to clinic time pressures, informed consent is often obtained on the morning of surgery for the first time. This study aims to assess whether consent quality and patients’ consent satisfaction are better in clinic compared to day of surgery.
Methods
Retrospective review of all elective laparoscopic surgeries between April and June 2021. Self-administered questionnaire was also completed by the same cohort to ascertain consent satisfaction.
Results
38 patients in total during study period. 16(42.1%) were consented in clinic, and 22 were first consented on day of surgery. 25/38(65.8%) patients prefer to be consented in clinic, 13(34.2%) prefer consent on day of surgery. Significantly higher proportion of consent forms from clinic had full documentation of risks and benefits of cholecystectomy (P<0.001) compared to consents from day of surgery. Significantly higher proportion of patients consented in clinic felt adequately informed of procedure, had alternative options explained to them, were informed regarding recovery process, and felt there was adequate time for consent (P<0.05). Insignificantly higher proportion of patients consented in clinic received information leaflet about procedure. Overall consent satisfaction was significantly higher in patients consented in clinic (77% versus 55%, P=0.048%)
Conclusions
Consent quality and patient satisfaction levels for elective cholecystectomy were statistically significantly higher when consent was carried out in clinic prior to surgery compared to on the day of surgery. We recommend that all elective cholecystectomy consent is performed formally in clinic prior to surgery.

Development of a core outcome set for informed consent for therapy: An international key stakeholder consensus study
Research
Liam J. Convie, Joshua M. Clements, Scott McCain, Jeffrey Campbell, Stephen J. Kirk, Mike Clarke
BMC Medical Ethics, 9 August 2022; 23(79)
Open Access
Abstract
Background
300 million operations and procedures are performed annually across the world, all of which require a patient’s informed consent. No standardised measure of the consent process exists in current clinical practice. We aimed to define a core outcome set for informed consent for therapy.
Methods
The core outcome set was developed in accordance with a predefined research protocol and the Core OutcoMes in Effectiveness Trials (COMET) methodology comprising systematic review, qualitative semi structured interviews, a modified Delphi process and consensus webinars to ratify outcomes for inclusion in the final core outcome set. (Registration—https://www.comet-initiative.org/Studies/Details/1024). Participants from all key stakeholder groups took part in the process, including patients and the public, healthcare practitioners and consent researchers.
Results
36 outcome domains were synthesised through systematic review and organised into a consent taxonomy. 41 semi-structured interviews were performed with all consent stakeholders groups. 164 participants from all stakeholder groups across 8 countries completed Delphi Round 1 and 125 completed Round 2. 11 outcomes met the ‘consensus in’ criteria. 6 met ‘consensus in’ all stakeholder groups and were included directly in the final core outcome set. 5 remaining outcomes meeting ‘consensus in’ were ratified over two consensus webinars. 9 core outcomes were included in the final core outcome set: Satisfaction with the quality and amount of information, Patient feeling that there was a choice, Patient feeling that the decision to consent was their own, Confidence in the decision made, Satisfaction with communication, Trust in the clinician, Patient satisfaction with the consent process, Patient rated adequacy of time and opportunity to ask questions.
Conclusion
This international mixed-methods qualitative study is the first of its kind to define a core outcome set for informed consent for intervention. It defines what outcomes are of importance to key stakeholders in the consent process and is a forward step towards standardising future consent research.

Informed Consent Practices in Global Surgery among Plastic Surgery Organizations
Special Topic
Kishan Thadikonda, Rosaline Zhang, Jonathan Bruhn, Phuong D. Nguyen, Samuel O. Poore
Plastic and Reconstructive Surgery, 8 August 2022
Abstract
Background
Global surgery organizations often serve vulnerable and complex patient populations, but there is limited knowledge on the protocols used to obtain informed consent for procedures and content sharing.
Methods
The Plastic Surgery Foundation Volunteers in Plastic Surgery (VIPS) database was queried for organizations actively involved in global surgery. Seventy-nine organizations received email invitations to participate in a survey study regarding their protocols for obtaining consent for procedures and sharing multimedia content.
Results
A total of 17 (22% yield) organizations completed the survey. All were active for at least 10 years and 88% (15/17) organized at least two mission trips annually. Eighty-eight percent (15/17) reported obtaining written consent for surgical procedures. Less than half (46%, 8/17) of used a written consent form that was created jointly with the local hospital. For sharing content related to global surgery experiences, 75% (12/16) obtained some form of written consent while 6% (1/16) did not routinely obtain any consent. Organizations shared content most commonly through their websites and Facebook. All organizations reported using interpreters to obtain informed consent at least some of the time. 62% (10/16) reported that they relied primarily on volunteers or community members to provide informal interpretation assistance, rather than formally trained professional interpreters.
Conclusion
Practices related to obtaining informed consent vary widely among global surgery organizations. The development of standardized protocols and guidelines will ensure that global health organizations, in collaboration with their local partners, properly obtain informed consent for procedures and sharing publicly viewable content.

Are we meeting the standards set for informed consent in spinal surgery?
Y Esemen, A Mostofi, D Richardson, EAC Pereira
Annals of Royal College of Surgeons, 29 July 2022
Abstract
Introduction
Informed consent empowers patients to exercise their autonomy and actively participate in their medical care. Guidance published by the British Association of Spine Surgeons (BASS) lists three components of consent: provision of information booklets, patient-centred dialogue and completion of appropriate consent forms. The aim of the study was to review the quality of the spinal surgery consent process against the BASS guidance in a single tertiary neurosurgery centre in London.
Methods
Retrospective review of clinic letters and consent forms was performed for 100 consecutive cases of elective, non-instrumented spinal decompression surgeries performed in 2019. Documentation was graded for inclusion of the intended benefit (improvement of pain/prevention of neurological deterioration), alternative management options (including no treatment), surgical options and risks (infection, bleeding, paralysis, sphincter disturbances, dural tear and recurrence). Provision of supplementary information booklets was recorded. Two-tailed Fisher exact test was used to calculate statistical significance where appropriate.

Results
Documentation of indications and risks of elective spinal surgery, specifically risk of recurrence (62%) and sphincter disturbance (85%), was suboptimal on the consent forms. Documentation of these risks was also poor in clinic letters (<50%). Alternative treatment options were explained in less than half of the clinic letters, and there was no documentation of information booklet provision prior to elective surgeries.
Conclusion
Lack of informed consent plays a major role in medical malpractice claims in spinal surgery. Poor documentation puts the surgeon in a liable position. BASS guidance could be implemented to create a more standardised process of consent in spinal surgery.