Training Surgeons and the Informed Consent Discussion in Paediatric Patients: A Qualitative Study Examining Trainee Participation Disclosure
Chang, K. Bhanot, S. Grant, A. Fecteau, M. Camp
Orthopaedic Proceedings, 17 July 2020; 102-B supplement 6
Open Access
Excerpt
The process of obtaining informed consent is an important and complex pursuit, especially within a paediatric setting. Medical governing bodies have stated that the role of the trainee surgeon must be explained to patients and their families during the consent process. Despite this, attitudes and practices of surgeons and their trainees regarding disclosure of the trainee’s participation during the consent process has not been reported in the paediatric setting.

Nineteen face-to-face interviews were conducted with surgical trainees and staff surgeons at a tertiary level paediatric hospital in Toronto, Canada. These were transcribed and subsequently thematically coded by three reviewers…

Evaluating the Patient and Setting-Specific Factors That Influenced the Quality of Informed Consent in a Retrospective Cohort of Subtotal Cholecystectomy Patients
Mina Mesri, Ikemsinachi C. Nzenwa, Raimundas Lunevicius
Journal of Laparoendoscopic & Advanced Surgical Techniques, 13 July 2020
Abstract
Introduction
Cholecystectomy is the most frequently performed procedure in general surgery. The consent procedure for cholecystectomy needs to inform patients about the possibility of subtotal cholecystectomy (STC) as an alternative procedure used for “difficult gallbladders” as it is associated with increased postoperative morbidity. We sought to determine the quality of informed consent for patients who were scheduled for cholecystectomy but underwent STC, and evaluate whether patient or procedural factors influenced the information discussed in consenting.
Materials and Methods
We classified 57 components of information necessary for a patient to give informed consent for cholecystectomy. We retrospectively reviewed the consent forms of patients scheduled for conventional cholecystectomy but instead undergoing STC between 2011 and 2017. Consent quality was measured as the percentage of components completed. Subgroup analyses were conducted to determine whether age, gender, American Society of Anesthesiologists grade, setting (elective/nonelective), operation mode (open/laparoscopic), or the responsible surgeon affected consent quality.
Results
Across 174 patients, just 9 (5.2%) had been informed about the possibility of undergoing STC, whereas the overall quality of consent was 37.5%. Patient and setting-specific factors affected the completion of specific consent components. Patients were more likely to receive a patient information leaflet if they were female (relative risk [RR] 2.76; 95% confidence interval [CI] 1.09–7.00), <60 years (RR 3.32; 95% CI 1.39–7.90) or undergoing laparoscopic surgery (RR 8.04; 95% CI 2.50–25.88).
Conclusion
The suboptimal quality of consent and multiple inconsistencies in the information disclosed to different patient cohorts emphasize the need for a more transparent and consistent consenting process.

The patient and clinician experience of informed consent for surgery: a systematic review of the qualitative evidence
Research Article
J. Convie, E. Carson, D. McCusker, R. S. McCain, N. McKinley, W. J. Campbell, S. J. Kirk & M. Clarke
BMC Medical Ethics, 11 July 2020; 21(58)
Open Access
Abstract
Background
Informed consent is an integral component of good medical practice. Many researchers have investigated measures to improve the quality of informed consent, but it is not clear which techniques work best and why. To address this problem, we propose developing a core outcome set (COS) to evaluate interventions designed to improve the consent process for surgery in adult patients with capacity. Part of this process involves reviewing existing research that has reported what is important to patients and doctors in the informed consent process.
Methods
This qualitative synthesis comprises four phases: identification of published papers and determining their relevance; appraisal of the quality of the papers; identification and summary of the key findings from each paper while determining the definitiveness of each finding against the primary data; comparison of key themes between papers such that findings are linked across studies.
Results
Searches of bibliographic databases returned 11,073 titles. Of these, 16 studies met the inclusion criteria. Studies were published between 1996 and 2016 and included a total of 367 patients and 74 health care providers. Thirteen studies collected data using in-depth interviews and constant comparison was the most common means of qualitative analysis. A total of 94 findings were extracted from the primary papers and divided into 17 categories and ultimately 6 synthesised findings related to: patient characteristics, knowledge, communication, the model patient, trust and decision making.
Conclusions
This qualitative meta-aggregation is the first to examine the issue of informed consent for surgery. It has revealed several outcomes deemed important to capture by patients and clinicians when evaluating the quality of a consent process. Some of these outcomes have not been examined previously in research comparing methods for informed consent. This review is an important step in the development of a COS to evaluate interventions designed to improve the consent process for surgery.

Readability of the informed consent forms in Flanders using the Douma index: Analyzing the documents that help patients make decisions
Research Article
María del Valle Ramírez-Durán, María del Valle Coronado-Vázquez, María Isabel Mariscal-Crespo
Clinical Ethics, 9 July 2020
Abstract
Informed consent forms have been useful in clinical practice and they constitute a part of the shared decision making in the informed consent process. They provide information to patients about clinical procedures and techniques. They also act as a remainder of the information discussed after the medical interview. Sometimes these documents are not readable to everybody. Belgian law specifies that all information that patients receive has to be proportionate verbally, but written information is also handled. The present research analyzes the readability of the Flemish informed consent forms located in the webs of all General Hospitals using a simple random sample of 75 informed consent forms.

By using the Douma tool, which bases its analysis in the length of words and sentences, the readability mean of the sample was 46, level “Difficult”. The 59% of them had a difficult level. The 11% were normal. It is a fact, then, that the 59% of the informed consent forms evaluated in this study are not suitable for everybody in Flanders, especially those people with low literacy. There were some researches made in other countries that agreed with these results. Written clinical information was poorly written so the informed consent forms were not working helping patients to recall information nor helping patients to become a part in the shared decision making about their health. The use of readability formulas represented a simple way to discriminate those informed consent forms that had normal readability scores from those that should be adapted.

Exploring the concept of ‘informed consent’ within the context of paramedic practice
Helen Taylor, James Brogan
Journal of Paramedic Practice, 7 July 2020; 12(7)
Abstract
The phrase ‘informed consent’ is used widely in healthcare. Practitioners ask their patients for their consent to a treatment or a diagnostic or monitoring procedure and, if consent is given, will document this. There is a general understanding that consent is a prerequisite for care and signifies the patient’s permission for the paramedic to proceed with assessments and other therapeutic interventions. Obtaining the patient’s informed consent is fundamental to contemporary healthcare: what is informed consent and why is it so important? This article explores the meaning of consent in practice and the purpose it serves. It will then go on to consider complex circumstances, including emergencies, young people aged under 18 years, when a patient is unable to give consent or where a person has capacity to consent but refuses.

Is there a standardised consent process within the surgical specialties?
James Hall, Ian Farrell, Sujala Kalipershad, James Hill
The Surgeon, 5 July 2020
Abstract
Introduction
The consent process is central to surgical practice. Subsequent to landmark cases such as Montgomery and Thefaut there is increasing consensus that consent should be a staged process. The aim of our survey was to identify if there was any homogeneity in the practice of surgeons with regards to the consent process in comparison to national guidelines.
Methods
Our survey was distributed to a broad range of surgical specialties via an anonymous Google Forms questionnaire available online. Consultant Surgeons and Specialist registrars across the United Kingdom were then contacted via their relevant surgical societies and professional. Data collection was based on the Montgomery principles: consent location; face to face meetings; information leaflets (including their source); distribution of copies of letters and consent forms; use of percentage risks; use of pre-printed consent forms.
Results
The total number of replies was 325. The majority of consent was taken on the day of surgery (166/319; 50.8%). Scheduled meeting for the consent process occurred routinely in only 87 cases (87/319; 27.3%). 103 (103/319; 32.9%) responders indicated the use of pre-printed consent forms. Of which 93 (93/103; 90.3%) were produced locally. Risk percentages were routinely used by 103 responders (103/319; 32.9%) Nearly two-thirds never write specific risk percentages routinely (205/319; 64.3%). Copies of consent forms were routinely given out by 210 responders (210/319; 65.8%). Supporting information was routinely given to patients in 248 cases (248/319; 77.7%).
Conclusion
Our survey documents significant variation in the practice of consent despite clear guidance on best practice. We believe that most surgeons welcome a more thorough and robust consent process, but hey need the time and infrastructure to be able to do it Introduction.

Informed Consent in Patients Undergoing Primary Hip and Knee Arthroplasty: What Do Patients Want to Know?
Nemandra A Sandiford, Maalee Mahendra, Lilanthi Wickramarachchi, Diane Back, Mohit Bansal
Cureus, 5 June 2020; 12(6)
Abstract
Introduction
The consenting process has been surgeon-focused traditionally, but there is a recent trend towards making the process more patient and procedure-focused. The primary aims were to identify the risks considered most important and requiring further discussion by the patients undergoing primary total hip arthroplasty (THA) and primary total knee arthroplasty (TKA), as well as to identify the sporting and recreational activities these patients would like to pursue after surgery according to the age group, taking into consideration their values and expectations. The secondary aim is to assess the compliance of the current consenting process with guidelines set out by a governing body in a tertiary referral arthroplasty unit.
Material and method
A prospective study reviewing the consenting process was carried out on 137 patients undergoing THA or TKA over a 12-month period in a tertiary teaching hospital. Patients unable to complete a questionnaire and undergoing revision or uni-compartment arthroplasty were excluded. A standardized anonymous questionnaire was administered. Patients were asked to fill in the specific activities they considered important to be discussed. The data were tabulated in Microsoft Excel (Microsoft Corporation, Redmond, Washington) and subgroup analysis was performed using the student’s t-test. The level of statistical significance was p=0.05. Two-hundred consent forms were reviewed to assess whether the information entered correlated to the guidelines presented in Ortho-Consent.
Results
One-hundred thirty-seven questionnaires were reviewed. The mean age was 66 (range 45-91), with the majority of patients undergoing TKA (114) versus THA (23). The patients in active employment were more concerned about blood clots, pain, joint failure, limb length discrepancy, and infection. Patients undergoing TKA wanted more information on pain management and joint longevity, which achieved statistical significance. There was a significant difference in the activities patients would like to pursue as well as in expectations amongst different age groups. The quality of documentation in the consent form was quite variable in discussing complications, surgery benefits, and alternative treatments.
conclusion
Obtaining consent is a patient-specific process. Patient perception of important points that merit discussion can vary with age and employment status. Return to driving is important for all ages, however, as the population ages, the ability to return to activities of daily living becomes an increasingly important discussion point during the consent process.

Editor’s Note: the Cureus Journal of Medical Science is an open access general medical journal based in San Francisco, California.

Rethinking counselling in prenatal screening: An ethical analysis of informed consent in the context of non‐invasive prenatal testing (NIPT)
Adriana Kater‐Kuipers, Inez D. de Beaufort, Robert‐Jan H. Galjaard, Eline M. Bunnik
Bioethics, 4 July 2020
Open Access
Abstract
Informed consent is a key condition for prenatal screening programmes to reach their aim of promoting reproductive autonomy. Reaching this aim is currently being challenged with the introduction of non‐invasive prenatal testing (NIPT) in first‐trimester prenatal screening programmes: amongst others its procedural ease—it only requires a blood draw and reaches high levels of reliability—might hinder women’s understanding that they should make a personal, informed decision about screening. We offer arguments for a renewed recognition and use of informed consent compared to informed choice, and for a focus on value‐consistent choices and personalized informational preferences. We argue for a three‐step counselling model in which three decision moments are distinguished and differently addressed: (1) professionals explore women’s values concerning whether and why they wish to know whether their baby has a genetic disorder; (2) women receive layered medical‐technical information and are asked to make a decision about screening; (3) during post‐test counselling, women are supported in decision‐making about the continuation or termination of their pregnancy. This model might also be applicable in other fields of genetic (pre‐test) counselling, where techniques for expanding genome analysis and burdensome test‐outcomes challenge counselling of patients.