Updated GMC guidance on decision-making and consent: implications for urologists
Research Article
Siobhan Duffy, Catriona Barlow, Mark Underwood, Elizabeth Day
Journal of Clinical Urology, 30 July 2020
Abstract
We summarise the updated General Medical Council guidance on consent and decision-making. We explore the emphasis on enabling supported decision-making and the implications this has in day to day urological practice. In particular, we address some of the issues encountered in one-stop clinics, on pooled elective lists and with pre-written consent forms. The new guidance will emphasise the importance of sharing information relevant to your patient in light of the Montgomery ruling. Every decision is unique. We must appreciate the importance of the process of decision-making and understand our role as the clinician. Here we suggest some practical considerations to address the updated General Medical Council guidance.

Influence of a Preadmission Procedure-Specific Consent Document on Patient Recall of Informed Consent at 4 Weeks After Total Hip Replacement: A Randomized Controlled Trial
Fiachra Richard  Power, Aine McClean, James Cashman
Journal of Patient Safety, 29 July 2020
Abstract
Objectives
Consent is a legal and ethical requirement for undertaking surgical procedures; however, the literature suggests that there continues to be poor recall among patients of the surgical risks discussed during the consent process. The aim of this study was to evaluate whether the addition of a preadmission procedure-specific consent document would improve patient recall of surgical risks at 4 weeks after total hip replacement in patients consented with a procedure-specific consent form.
Methods
A prospective randomized controlled trial allocated seventy adult patients who were undergoing a primary total hip replacement to either receive (intervention group) or not receive (control group) a preadmission procedure-specific consent document. All patients were also consented with a procedure-specific consent form on the morning of surgery and were contacted 4 weeks later to assess recall of surgical risks.
Results
There was a very poor recall rate seen in both the intervention group (16%) and the control group (13%), with no statistically significant difference between them (P = 0.49). A large number (30%) of patients could not recall a single risk. A subgroup analysis excluding these “consent nonresponders” did show a significantly increased recall rate in the intervention group (24.5% versus 18.25%, P = 0.02).
Conclusions
Patient recall of potential complications of total hip replacement was poor despite the intervention. Although not effective overall, the use of a preadmission procedure-specific consent document did improve recall of potential complications of surgery in a subset of patients. The phenomenon of consent nonresponders is worth exploring in future research.

What Matters to Patients and Families: A Content and Process Framework for Clarifying Preferences, Concerns, and Values
Research Article
Rhéa Rocque, Selma Chipenda Dansokho, Roland Grad, Holly O. Witterman
Medical Decision Making, 22 July 2020
Abstract
Background. Values clarification, or sorting out what matters to a patient or family relevant to a health decision, is a fundamental part of shared decision making. We aimed to describe how values clarification occurs in routine primary care. Methods. Using framework analysis and an established taxonomy, 2 independent researchers analyzed 260 consultations in 5 family medicine clinics across Quebec. Two questions guided our analyses: 1) What categories exist regarding what matters to patients? 2) What patterns exist in discussions of what matters to patients? Results. 1) Five distinct categories of what matters to patients and families were discussed during values clarification: preferences, concerns, treatment-specific values, life goals or philosophies, and broader contextual or sociocultural values. Preferences and concerns were the matters most commonly raised. 2) Diverse patterns of values clarification emerged based on 3 analytical questions: Who initiates the discussion about what matters to patients? When? What information is discussed? The most frequent pattern was clinicians soliciting patients’ concerns and preferences during the information-gathering phase. The second most common pattern was similar, except that patients’ spontaneously raised what matters to them. Limitations. The study was descriptive and based on audio-recorded visits. We did not interview patients and clinicians to elicit their perspectives. Conclusions. There are 5 distinct categories of what matters to patients and families as well as clear patterns of how values clarification occurs in routine primary care consultations. Clinicians could be sensitive to these categories when engaging in the process of values clarification and may wish to pay particular attention to the opening minutes of a consultation. This study provides a structure for future identification of best practices in values clarification.

Informed Consent Guidelines for Optimizing the Use of Telomerase-Positive Stem Cells
Henry E Young, Mark O Speight
Journal of Regenerative Medicine & Biology Research, 22 July 2020
Open Access
Abstract
The objectives of the work, based on previous characterization studies, pre-clinical animal models of induced diseases, e.g., Parkinson disease, cardiovascular disease, pulmonary disease, and type-I diabetes mellitus, and early clinical human studies of Parkinson disease, cardiovascular disease, and pulmonary diseases, were to established a set of criteria that needed to be followed for using telomerase-positive stem cells in future human clinical trials. From this set of criteria, informed consent guidelines were established to optimize the safety and efficacy of using endogenous adult-derived telomerase-positive stem cells to restore organ function by either repair and/or regeneration of cells and tissues resulting from tissue damage and/or loss. Inclusion criteria were any male or female, 18 to 120 years of age, with preferably no serious comorbidities. Exclusion criteria were use of alcohol, tobacco products, vaping, recreational drugs, lidocaine, and/or chemotherapeutic drugs. We also cautioned use of caffeine and corticosteroids, as well as limiting moderate to strenuous physical activity within a two week window before and after stem cell treatment. Following these inclusion and exclusion criteria, endogenous adult-derived autologous and/or allogeneic telomerase-positive stem cells have proven to be both safe and effective at restoring (up to 50% above pre-treatment values in compliant individuals) organ function for diseases and/or disorders caused by trauma or chronic diseases. Conditions treated thus far, within IRB-approved human study protocols, include neurodegenerative, cardiovascular, pulmonary, autoimmune, renal, and orthopedic disorders.

Medicaid Sterilization Consent Forms: Variation in Rejection and Payment Consequences
Research Letter
Neena Qasba, Baystate HealthFollow
American Journal of Obstetrics and Gynecology, July 2020
Open Access
Abstract
Objective
In 1974, the federal Sterilization Consent Form (SCF) was created for those with publicly funded insurance to document appropriate informed consent by a clinician for sterilization procedures. This form must be signed by the clinician and patient at least 30 days before the procedure and expires 180 days after being signed. While there are numerous barriers to desired sterilization, the Medicaid consent process is a major cause of unfulfilled sterilization requests. As long as they comply with federal statutes, states may modify the Medicaid SCF, further complicating this process. However, data regarding this state-level variability is largely unavailable. Federal policy dictates that the global obstetrical fee should not be affected by SCF rejection. We sought to describe how individual state Medicaid policies differed in terms of what constitutes proper SCF completion and the payment ramifications of a rejected SCF.
Study design
A 25-question survey was administered with Qualtrics XM® to 50 United States state Medicaid Directors or the most appropriate state official based on a review of the state website. The survey assessed state officials’ knowledge of criteria used to assess completion and validity of SCFs, SCF rejection rate, and payment ramifications for rejected SCFs. Data were collected from January to May 2020. Deidentified data were analyzed and reported in aggregate. This study was given Exempt Status by the Tufts Health Sciences Institutional Review Board.
Results
There were 41 responses from 36 states for a 72% participation rate. Four states had submitted multiple nonidentical responses. Criteria for SCF rejection included an incomplete form (35, 85%), mismatching or incorrect dates/times on the SCF (28, 68%), and that greater than 180 days had passed since the patient’s signature rendering the form expired (27, 66%) (Figure 1A). Ten respondents (24%) estimated a SCF rejection rate of less than or equal to 10% while four respondents (10%) indicated a greater than 30% rejection rate (Figure 1B). The majority of respondents indicated that the ramification of a rejected SCF included the loss of payment for the postpartum sterilization procedure for the provider (32, 78%) as well as facility (29, 71%). Five respondents stated that a rejected SCF resulted in loss of the entire obstetrical global payment for provider and facility (5, 12% provider; 5, 12% facility).
Conclusion
From our survey, it is clear that wide variation exists between states or within individual states, in the criteria used by state Medicaid offices to assess SCF completion, rate of rejections, and subsequent payment ramifications for providers and facilities. While the majority of respondents identified objective measures (e.g. incorrect dates) as major reasons to reject SCFs, many also used subjective reasons (e.g. signature legibility). Though federal policy dictates that the global fee should not be affected by SCF rejection, our study found 12% of respondents indicated a loss of the global fee. The fear of payment loss can be a significant barrier to desired sterilization. Ensuring greater transparency and consistency in the Title XIX sterilization consent process within and between states is a key step to ensuring equitable access to postpartum sterilization.

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.