Is The Consent Process Appropriate - The Interns’ Perspective?

Rohan P1,2, Keane K1, Nason GJ2, Caulfield RH1

1Department of Plastic Surgery, Mater Misericordiae University Hospital, Dublin 7
2Department of Urology, Mater Misericordiae University Hospital, Dublin 7

Abstract

Aims
Consent is an integral component to any medical procedure involving a competent patient, a communicating doctor, and transfer of information about the procedure. The aim of this study was to assess interns’ experience of the consent process.
Methods
An online questionnaire was distributed to interns in Ireland questioning their role in the consent process within six months of starting as an intern.
Results
One hundred and seventy-one interns (89.1%) had consented a patient for a procedure during their first intern rotation. One hundred and forty-three (83.6%) reported their supervisors did not explain the procedure to the intern prior to consent. One hundred and fifty-eight (92.4%) respondents consented for a procedure which they had not witnessed before. Sixty (35.1%) of interns reported that they have obtained signed consent without fully discussing the procedure and the associated risks.
Conclusion
The most junior members of a team are independently consenting patients on a regular basis without the appropriate level of knowledge.

Introduction
Consent is an integral component to any medical or surgical procedure- the key steps involve a competent patient, a clearly communicating doctor, and transfer of focused information about the planned surgical procedure1. It is a time consuming exercise which details a patient’s diagnosis and prognosis, the purpose of the intervention, the benefits and potential risks and any existing alternatives including non-operative and conservative measures2.

A detailed consent can take a significant amount of time which often is a challenge in a busy clinic setting particularly when consent is obtained the morning of a procedure as part of the admissions process. The person obtaining the consent ideally should be the person performing the procedure but in practice that is often not the case and often junior doctors complete this task3,4. The Irish Medical Council’s Guide to Conduct and Ethics states that “no part of the consent process should be delegated to an intern unless the procedure is a minor one with which the intern is very familiar and the intern’s medical supervisor has clearly explained the relevant information about the procedure to them”. If this is not possible it is acceptable for the treating doctor to delegate responsibility of part or all of the procedure to another suitably trained and qualified person. This person must have sufficient knowledge of the procedure and risks involved and are able to explain and discuss these with the patient. If consent is delegated, responsibility remains with the treating doctor to ensure consent has been given5. The optimal pathway for consent should involve the operating surgeon or practioner; it should be performed in advance of the procedure with adequate supplemental material (information leaflets, videos, and websites) and in a non-pressurised environment. Doctors often underestimate the degree of information patients want to know- it is not a physicians role to decide this- patients should be fully informed regarding all procedures6,7.

Procedure specific consent forms and patient information leaflets are useful adjuncts which can help the consenting doctor and the patient. Appropriate consent and communication are paramount to maintain the doctor-patient relationship and failure to appreciate this can lead to significant medico-legal consequences. The aim of this study was to assess the current practice in Irish hospitals regarding intern’s involvement and experience with the consent process.

Methods
Interns are newly qualified medical doctors. Intern year involves three or four month rotations through medical and surgical specialties. An electronic survey was distributed to all interns in Ireland questioning their role in the consent process within six months of starting as an intern. The survey was created using the Google Forms tool and circulated all intern networks through social media pages (Facebook and Whatsapp). Users accessed the survey via a url link over a five month period and all responses were anonymously recorded. The survey focused upon interns’ involvement and experiences with the consent process.

All responses were recorded in a departmental database. If an intern had not been involved in the consent process the questions relating directly to obtaining consent were automatically skipped and the respondent was directed straight to questions regarding their opinions on how the consent process could be improved. The primary outcome was to assess how many interns were independently involved in the consent process. Secondary outcomes were to assess was this performed in adherence with the Guide to Professional Conduct and Ethics from the Irish Medical Council.

Results
For the academic year 2016/2017 there was a total of 727 interns in Ireland. The response rate of the survey was 26.4% (n=192 interns). One hundred and seventy-one (89.1%) interns had consented a patient for a procedure or surgery during their first intern rotation. One hundred and forty-three (83.6%) reported their medical supervisors (consultants or senior team members) did not usually explain the procedure to the intern prior to consent. One hundred and fifty-eight (92.4%) respondents consented for a procedure which they had not witnessed before. All (n=171) of those who did consent said they were not usually observed by a more senior doctor when obtaining consent. 57 (91.8%) of those who did obtain consent at least once were expected to do so on a regular basis by their team and 114 (66.7%) felt pressurised into doing so. One hundred and thirteen (66.1%) spent between two and five minutes obtaining consent on average per patient with 80 (46.8%) respondents acknowledging time constraints as a barrier to better consenting.

When faced with an unfamiliar procedure or treatment 35 (20.5%) interns responded that in such a scenario they would consent vaguely. One hundred and sixty-four (95.9%) reported looking up the procedure with which they were unfamiliar and 64 (37.4%) would ask their team for help. When researching procedures the most common source of further information was the internet with 169 (98.8%) interns looking up procedures here. Sixty (35.1%) interns reported that they have obtained signed consent without fully discussing the procedure or treatment and the associated risks. While 132 (77.2%) did include the risks of anaesthesia when consenting, only 57 (33.3%) would include the risk of myocardial infarction, stroke and death as part of the consent for a surgical procedure.

When asked to consider the quality of their consenting, 87 (50.9%) felt they consented completely and satisfactorily most of the time, 34 (19.9%) nearly all of the time, 37 (21.6%) sometimes and 13 (7.6%) rarely. The main obstacle to this was a lack of knowledge according to 152 (88.9%) interns. One hundred and twenty (62.5%) were unaware of any national guidelines regarding consent and 138 (71.9%) had not read the Medical Council’s Guide to Professional Conduct and Ethics guidance on consenting. Ninety-nine (57.9%) respondents reported they did not know if there was a policy regarding consent with their hospital and 42 (24.6%) reported that no such policy existed.

One hundred and twenty-one (63%) respondents felt that it is appropriate for interns to obtain consent with adequate training including formal training 50.5% (n=97), procedure specific consent templates, 91.1% (n=175) and procedure specific patient information leaflets 74.5% (n=143). One hundred and seventy-seven (92.2%) would prefer that consent for surgery should be obtained by an operating surgeon in an outpatient setting if applicable.

Discussion
Our study demonstrates some concerning aspects about the current practice of the consent process in Ireland. The majority of interns consent for procedures on a regular basis from early in their career. They are independently consenting for procedures they have never even witnessed and at times do not have appropriate knowledge of the procedure. They are consenting under pressure from senior colleagues and under significant time constraints. Even more worryingly, only half consider their consent satisfactory and over a third consent without fully discussing the procedure. This study highlights some issues with the consent process in our healthcare system. Interns feel it is appropriate for a junior doctor to obtain consent if they are appropriately trained and adjuncts such as patient information leaflets and procedure specific consent forms would be useful.

It is not uncommon for junior doctors to obtain consent for invasive procedures. Uzzaman et al, reported less than 20% of patients are consenting by a consultant surgeon for a laparoscopic cholecystectomy4. However the concerning feature is highlighted by Angelos et al, who demonstrated that junior doctors were unable to answer questions regarding common complications of general surgical procedures such as hernia repairs and cholecystectomy8, which may also be the case in our study given half of our respondents were not satisfied with their consent. Interestingly Shiwani et al reported a less detailed consent was obtained from consultant surgeons for hernia repairs compared to junior staff particularly concerning nerve injury, testicular problems or visceral and vascular damage9. Cawich et al, reported that half of patients are unaware of the training level of the doctor obtaining their consent and similarly half would like further information about the operating surgeon10 - likely down to the time constraints admitting doctors are under- something highlighted by our survey. Despite our study also showing junior doctors are consenting regularly- the Irish Medical Council states that when the operating doctor cannot obtain consent that it is possible ‘to delegate responsibility of part or all of the procedure to another suitably trained and qualified person’5.Undoubtedly- a newly graduated doctor is not in this position.

The timing for consenting a patient is often debated. Many patients are now consented on admission the day of surgery4. It has been shown that patients are most informed and information recall is best immediately after signing the consent form and the longer the interval from consent process to surgery, the poorer the recall of the consent process11. Despite the use of additional information leaflets, direction to verified websites or consenting in the outpatients department- patients level of understanding of surgical procedures has been documented to be poor12,13. The ideal scenario involves a patient being informed at each step in the process- at diagnosis in the outpatient setting, on admission for their procedure and also offered a further time to ask questions prior to the procedure by an appropriately informed medical practitioner. It is not the doctor’s role to decide how much information a patient is required to know. Degerliyurt et al., demonstrated that less than 10% of patients did not want to know about complications of procedures with the majority wanting to know about all potential complications14. Akkad reported interesting differences in patient’s satisfaction with the consent process for emergency and elective procedures. Patients were less likely to understand the consent, felt less satisfied with the consent and felt they had less choice in an emergency scenario15.

The consent process is of paramount importance from a medico-legal perspective. Landmark legal cases dictate the consent process. The Montgomery v Lanarkshire case of March 2015 redefined the standard for informed consent and disclosure16. Previously, the Bolam test was used to determine what should be disclosed. The Bolam test asks whether a doctor’s conduct would be supported by a responsible body of clinicians17. The Montgomery case firmly rejected the Bolam test regarding consent, establishing a duty of care to warn of material risks. A material risk was deemed that which ‘a reasonable person in the patient’s position would be likely to attach significance to the risk, or the doctor is or should reasonably be aware that the particular patient would be likely to attach significance to it.”

Our study has a number of limitations- this one sided study merely assesses the interns perspective and experience. There was no data collected regarding the patients perspective of the consent process. Furthermore, we did not stratify the type of procedure- general/local anaesthesia or major/minor surgery- it is likely that more senior members were involved in consenting for major surgery. Furthermore, given that the respondents work in different hospitals and graduated from different medical schools we did not clarify the extent if any of teaching they received regarding the consent process.

Despite guidance from Irish Medical Council outlining the platform for consenting- interns play a significant role in the consent process for invasive procedures on a regular basis without the appropriate level of knowledge of the procedure.

Conflicts of Interest
The authors have no conflicts of interest to declare.

Corresponding Author:
Mr Gregory Nason, FRCS Urol. Specialist Registrar in Urology, Mater Misericordiae University Hospital, Eccles Street, Dublin 7,Ireland
Email: nasong@tcd.ie

References
1. Leclercq WK, Keulers BJ, Scheltinga MR, Spauwen PH, van der Wilt GJ. A review of surgical informed consent: past, present, and future A quest to help patients make better decisions. World J Surg. 2010 Jul;34(7):1406-15
2. Good Surgical Practice. London: 2014. The Royal College of Surgeons.
https://www.rcseng.ac.uk/surgeons/surgical-standards/professionalism surgery/gsp/documents/good-surgical-practice-pdf
3. Wood F, Martin SM, Carson-Stevens A, Elwyn G, Precious E, Kinnersley P. Doctors' perspectives of informed consent for non-emergency surgical procedures: a qualitative interview study. Health Expect. 2016 Jun;19(3):751-61.
4. Uzzaman MM, Tayeh S, Sinha S, Ratnasingham K, Stoker DL. Consenting practice for laparoscopic cholecystectomy - are we doing enough to warn patients about their operation? Int J Surg. 2011;9(8):643-7.
5. Irish Medical Council Guide to Professional Conduct and Ethics for Registered Medical Practitioners 8th Edition 2016
6. Hoermann S, Doering S, Richter R, Walter MH, Schussler G. Patients’ need for information before surgery. Psychother Psychosom Med Psychol. 2001 Feb;51(2):56-61.
7. Beisecker A, Beisecker T. Patient information seeking behaviours when consulting with doctors. Med Care. 1990 Jan;28(1):19-28.
8. Angelos P, DaRosa DA, Bentram D, Sherman H. Residents seeking informed consent: are they adequately knowledgeable? Curr Surg. 2002 Jan-Feb;59(1):115-8.
9. Shiwani MH, Gosling J. Variations in the quality of consent for open mesh repair of inguinal hernia. Hernia. 2009 Feb;13(1):73-6.
10. Cawich S, Barnett A, Crandon I, Drew S, Gordon‐Strachan G. From the patient's perspective: is there a need to improve the quality of informed consent for surgery in training hospitals? Perm J. 2013 Fall;17(4):22-6.
11. Lavelle-Jones C, Byrne DJ, Rice P, Cuschieri A. Factors affecting quality of informed consent. BMJ. 1993 Apr 3;306(6882):885-90.
12. Mulsow JJ, Feeley TM, Tierney S. Beyond consent-improving understanding in surgical patients. Am J Surg. 2012 Jan;203(1):112-20.
13. Dillon MF, Carr CJ, Feeley TM, Tierney S. Impact of the informed consent process on patients' understanding of varicose veins and their treatment. Ir J Med Sci. 2005 Jul-Sep;174(3):23-7.
14. Degerliyurt K, Gunsolley JC, Laskin DM. Informed consent: what do patients really want to know? J Oral Maxillofac Surg. 2010 Aug;68 (8):1849-52
15. Akkad A, Jackson C, Kenyon S, Dixon‐Woods M, Taub N, Habiba M. Informed consent for elective and emergency surgery: questionnaire study. BJOG. 2004 Oct;111(10):1133-8.
16. Montgomery (Appellant) v Lanarkshire Health Board (Respondent) (Scotland) [2015] UKSC 11.
17. O'Brien JW, Natarajan M, Shaikh I. A survey of doctors at a UK teaching hospital to assess understanding of recent changes to consent law. Ann Med Surg (Lond). 2017 Apr 21;18:10-13.

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