Complex surgery and optimal consent: A variety of opinions exist among healthcare professionals
Cillian Clancy, Niamh McCawley, John P. Burke, Deborah McNamara
The Surgeon, 29 December 2021
Abstract
Background
Establishing healthcare professional’s views on optimal consent in complex surgery could guide tailored consent policy, improving the process in challenging scenarios. To date, no studies have established if professionals of differing specialities agree on major aspects of consent in areas such as emergency surgery and cancer surgery.
Methods
An anonymous web based survey was distributed to a variety of disciplines in a tertiary referral centre. Questions regarding optimal methods and timing of consent in emergency and cancer surgery were posed. Comparative analyses of quantitative data were performed using chi-squared test.
Results
57 responses were received from doctors and nurses of varying disciplines. Differences were found between doctors of separate specialities and nurses in opinion of optimal timing of consent (p = 0.02), consent validity over time (p < 0.001) and the utility of introducing more specific consent policy (p = 0.01). Almost all respondents agreed that healthcare professionals have differing ideas of what consent is.
Conclusions
This study demonstrates differences in opinion regarding optimal consent for cancer and emergency surgery. Consideration should be given to developing consensus among healthcare professionals regarding what consent for complex surgery constitutes.

Patient and Clinician Perceptions of Informed Consent and Decision Making About Accepting KDPI > 85 Kidneys
Karolina Schantz, Elisa J. Gordon, Unsun Lee, Maria Rocha, John Friedewald, Daniela P. Ladner, Yolanda Becker, Richard Formica, Peter P. Reese, Dixon Kaufman, Masoud Barah, Marissa Walker, Om Mehrotra, Dania Viveros, Sanjay Mehrotra
Transplantation Direct, January 2022; 8(1) pp e1254
Abstract
Background
Although the impact of the kidney donor profile index (KDPI) on kidney discard is well researched, less is known about how patients make decisions about whether to give consent for KDPI > 85 kidney offers.
Methods
We conducted in-depth, semistructured interviews with 16 transplant recipients, 15 transplant candidates, and 23 clinicians (transplant surgeons, nephrologists, and nurse coordinators) to assess and compare perceptions of transplant education, informed consent for KDPI > 85 kidneys‚ and the decision-making process for accepting kidney offers. Thematic analysis was used to analyze qualitative data.
Results
Four themes emerged: (1) patients reported uncertainty about the meaning of KDPI or could not recall information about KDPI; (2) patients reported uncertainty about their KDPI > 85 consent status and a limited role in KDPI > 85 consent decision making; (3) patients’ reported willingness to consider KDPI > 85 kidneys depended on their age, health status, and experiences with dialysis, and thus it changed over time; (4) patients’ underestimated the survival benefit of transplantation compared with dialysis, which could affect their KDPI > 85 consent decision making.
Conclusions
To better support patients’ informed decision making about accepting KDPI > 85 kidneys, centers must ensure that all patients receive education about the trade-offs between accepting a KDPI > 85 kidney and remaining on dialysis. Additionally, education about KDPI and discussions about informed consent for KDPI > 85 kidneys must be repeated at multiple time points while patients are on the waiting list.

Should medical students perform pelvic exams on anaesthetised patients without explicit consent?
Research Article
Chloe Bell, Nathan Emmerich
Clinical Ethics, 28 December 2021
Abstract
There have been many reports of medical students performing pelvic exams on anaesthetised patients without the necessary consent being provided or even sought. These cases have led to an ongoing discussion regarding the need to ensure informed consent has been secured and furthermore, how it might be best obtained. We consider the importance of informed consent, the potential harm to both the patient and medical student risked by the suboptimal consent process, as well as alternatives to teaching pelvic examinations within medical school. The subsequent discussion focuses on whether medical students should perform pelvic examinations on anaesthetised patients without personally ensuring that they have given their explicit consent. Whilst we question the need to conduct pelvic examinations on anaesthetised patients in any circumstance, we argue that medical students should not perform such exams without personally securing the patients informed consent.

Perceptions and practices regarding the process of obtaining informed consent from surgical patients at a tertiary care hospital
Cross-sectional Study
Muhammad Asharib Arshad, Naureen Omar, Muhammad Zaid Amjad, Khalid Bashir, Muhammad Irfan, Irfan Ullah
Annals of Medicine and Surgery, 22 December 2021
Abstract
Background
Proper informed consent is essential for patients to have sound knowledge about the indication, risks, and benefits of a proposed surgical procedure. The study aim was to assess the perceptions of postoperative patients about the informed consent process and identify various influential factors in a tertiary care hospital.
Methods
A cross-sectional study was conducted from February to August 2018 at a tertiary care hospital in Lahore, Pakistan. A validated questionnaire was used to conduct interviews of 101 patients planning to undergo elective surgery after fulfilling all ethical considerations. A purposive sampling technique was employed to enroll and the data analysis was
performed by using SPSS version 23.
Results
Out of total 101 patients, 50 (49.5%) of them were males and the mean age of total sample was 36.98 ± 14.23 years. The majority 92 (91.1%) considered informed consent to be important and that it did not influence their surgical decision 85 (84.2%). Consent was obtained by the consulting surgeon from 41 (40.6%) patients and by the residents/house officer from 60 (59.4%) patients. Fifteen (14.8%) patients signed the consent form themselves, and 86 (85.1%) relatives of patients signed. Ninety-eight (97.0) patients were told about indications of the surgery, and 54 (53.5%) were told about possible complications. Seventy-five (74.3%) patients were informed about alternatives to surgery. Significant reasons for not signing were language (p = 0.03), educational status (p = 0.002), and not being informed by relatives before signing (p = 0.02).
Conclusion
The patients had adequate knowledge about the process of informed consent and considered it important. Factors identified as barriers to signing the consent form by the patients themselves included language, better educational status, and not being asked by relatives. It is imperative to involve the patients in the process of consent, especially in signing by them or in their presence by their surrogate.

Upgrading the Chemotherapy Consent: Trading in Paper for Tablet
Lesley Wu, Cardinale B. Smith, Jessica Parra, Mark Liu, Haley Hines Theroux, Aarti S. Bhardwaj
JCO Oncology Practice, 15 December 2021
Abstract
Purpose
Our institution participated in the Oncology Care Model, which required us to include many of the 13 elements of the National Academy of Medicine (NAM) care plan into care pathways for our patients. We optimized our existing chemotherapy consent process to meet this need and maximized completion.
Methods
Our multidisciplinary committee developed a three-phase Plan-Do-Study-Act process in our breast cancer clinic: (1) update and educate providers on our paper chemotherapy form with multiple components of the NAM care plan including prognosis and treatment effects on quality of life; (2) piloted an electronic chemotherapy consent form to decrease the administrative burden; and (3) autopopulated fields within the electronic consent. We assessed feedback after cycle 1 and created a Pareto chart. The outcome measure was percent completion of chemotherapy consent documents.
Results
Baseline monthly random chart audit of 40 patients revealed 20% of paper chemotherapy consent forms were completed in their entirety among patients. When we re-educated clinicians about the new paper consent containing the NAM elements, compliance rose to nearly 30%. A Pareto chart confirmed that content redundancy and wordiness were leading to under-completion. After creating and piloting the electronic consent, compliance increased to 90%. Finally, autopopulation with drop-down selections increased and sustained completion to 100%.
Conclusion
Incorporating regulatory requirements into an existing workflow using Plan-Do-Study-Act methodology can reduce administrative burden on clinicians. Additional use of innovative technology can further increase clinician compliance with regulatory requirements while delivering high-value quality care to patients with cancer.

A survey on current practice of informed consent process in surgical specialties of a tertiary teaching hospital center: What is the state of play?
Research Article
Ana Luísa Vieira, Cândida Infante, Sérgio Santos, Mariana Asseiro, Celine Ferreira
Research Square, 1 December 2021
Abstract
Background
Informed consent is essential in current medical practice and should be a global standard to be sought at all instances when doctors interact with patients. The aim of this study was to evaluate compliance to the guidelines of the Portuguese health entity regarding the correct filling process of informed consent.
Methods
A prospective observational survey was conducted upon arrival of the patient at the operating room of a tertiary teaching hospital center in Portugal, in march 2021, to verify the presence of informed consent in the clinical process. A sample of 202 clinical files was randomly collected.
Results
Only 47% of the patients had the informed consent document in the clinic process and only 45% of the total clinical files had the informed consent signed by the patient. Merely 21.8% of the informed consents respected all the items recommended by the guidelines of the Portugal health entity. Most of the surgical informed consent (SIC) had only basic information and only a lower percentage had reports about the surgical procedure, information regarding the treatment, possible consequences of a missed treatment or complications and possible treatment alternatives. Those results didn’t conform to the standard regulations of the Portuguese health guidelines regarding SIC.
Conclusion
Even though improvements in SIC were attained in recent years, our study suggests that the implementation of SIC is still suboptimal in surgical practice. It is important to raise awareness for the obtention of SIC by the healthcare team, because complete information before an invasive procedure is an ethical requirement.

Exploring the Adequacy of Obtaining Informed Consent for Caesarean Deliveries – A Patient Perspective
Theletsane, T. Cronje, B.G Lindeque, S. Adam
Obstetrics and Gynaecology Forum, 30 November 2021; 31(2)
Abstract
Obstetrics
The objective of this study was to assess the adequacy of informed consent obtained from patients prior to caesarean delivery.
Design
Descriptive study
Setting
Tertiary level hospitals in a major South African center in Pretoria, South Africa Subjects: Two-hundred-and-fifty patients who underwent elective and emergency caesarean deliveries
Outcome Measures
The assessment of the adequacy of the informed consent was assessed via a questionnaire that the participants answered on day 2-3 post caesarean delivery.
Results
Average age of participants was 28.8 years (28.75 ± 5.92). Twenty three percent (23.2%) of the participants underwent elective and 76.8% underwent emergency caesarean deliveries. Seventy five percent (75.6%) of the participants knew the name of the procedure, although only 29.2% were aware of the associated risks, and 59.2% of participants knew of their right to refuse the procedure.
Conclusion
Adequate communication is essential to all aspects of medicine and this study has highlighted the inadequacy of the informed consent process that takes place at our institution. Information regarding risks and complications was not adequately communicated. A standardized informed consent document that healthcare professionals can use for counseling, starting antenatally, should be considered.

Is informed consent practice in a general surgery unit adequate? An audit report
Original Article
Sameeah Hanif, Muhammad Nawaz, Sumera Naseem
Pakistan Journal of Medical Sciences, 29 June 2021; 37(3) pp 192-195
Open Access
Abstract
Objective
To obtain an informed consent is essential part of surgical practice. It not only ensures patients rights but also decreases the chances of legal proceedings against surgeons in case of any issue from procedure. The objective of this study is to evaluate the prevailing practices of getting informed consent and documentation in case of general surgical patients.
Material and Methods
This cross sectional (audit) study was carried out in department of Surgery District Head Quarter (DHQ), Abbottabad from December 2020 till February 2021 in general surgical unit. 132- patients chosen randomly were included. Both cases of elective as well as emergency cases were included. Patient operated on General and spinal anesthesia were interviewed according to questionnaire relating to informed surgical practices. Data of interviewed patients were analysed using spss 17.
Results
132 patients were included in study. Mean age was 34.98±16.1 years. Study comprised of 70 female(53%) and 62(47%) male. 117(88.6%) consent were taken by house officers while 15(11.4%) consent were taken by operating surgeon. 84(63.6%) consent were signed by patients themselves while 48(36.4%) were signed by relatives. All 132(100%) consent were written consent.
Conclusion
The quality of obtaining consent is below optimal and needs improvement. Education amongst health care workers is required so that they realize the importance of patients right’s so they make their own independent decision in the light of knowledge given. Also knowing that to have a complete and up to mark consent is beneficial for clinician in case of legal issues.

The Microethics of Informed Consent for Early Feminizing Surgery in Congenital Adrenal Hyperplasia
Katharine B. Dalke, Arlene B. Baratz
Journal of Pediatric Ethics, Spring 2021
Open Access
Abstract
Early surgery for genital difference in 46,XX congenital adrenal hyperplasia (CAH) is highly controversial, with contested evidence of benefits and risks. While professional urological societies and a parent-led CAH advocacy group maintain that families should have the option to consent for surgery for their child, former patients, intersex-led advocacy groups, and human rights and medical organizations denounce surgery on unconsenting infants for non-life-threatening genital variations. In the absence of clear data, clinicians are encouraged to engage in shared decision making with parents to obtain their fully informed consent. Unexplored microethics issues regarding clinicians’ implicit bias for treatments may interfere with their ability to obtain parents’ fully informed consent in this setting. Implicit bias may be inferred from parents’ experiences and from official and unofficial communications from clinicians.

The Urine Drug Screen in the Emergency Department: Overuse, Technical Pitfalls, and a Call for Informed Consent
Megan Yu, Charles Desmond Donohoe
International Journal of Health Systems and Translational Medicine, 2022
Abstract
Urine drug screens (UDSs) are often performed in the emergency department (ED) as part of a standard ED order set in patients with significant altered mental status, trauma, or seizures usually without the patient’s knowledge or specified informed consent. In the ED the UDS has been included in the standard consent to treatment for routine testing along with blood studies, EKG, urinalysis and radiology. Many technical factors are known to effect UDS results.There is a lack of education among physicians regarding the clinical pitfalls of UDS interpretation. This article discusses the current state and issues associated with the UDS, and presents three clinical vignettes that illustrate the impact of false-positive UDS results on patient care and the potential for a patient becoming unknowingly and unfairly stigmatized. The article also offers suggestions including a requirement for either formal informed consent or an “opt out” screening process, as recommended by the CDC in HIV testing, designed to protect patient autonomy and confidentiality.