Assessing Adult Patients’ Understandings of Secondary Malignancy Risk Terms in Radiation Therapy Consent

Assessing Adult Patients’ Understandings of Secondary Malignancy Risk Terms in Radiation Therapy Consent
N.Vartanian, M.Wilson, R.P.Ermoian
International Journal of Radiation Oncology*Biology*Physics, 1 November 2022; 114(3) pp e500-e501
Abstract
Purpose/Objective(s)
Informed consent is an essential component of cancer care. The terms “second tumors” or “secondary tumors” are sometimes used in radiation therapy consent. Their incidences are sometimes described as “rare,” although vary greatly from nearly negligible in patients treated with palliative intent, to 20% in young patients undergoing myeloablative total body irradiation. We evaluated whether patients without prior knowledge of radiation therapy interpret the terms in a way consistent with physician intent.
Materials/Methods
We screened 164 adult subjects who did not require medical interpreters at a university-affiliated family medicine clinic, excluding cancer patients and those with any prior knowledge of or experience with radiation treatment. One hundred subjects were eligible for and completed a 12-question multiple choice questionnaire, which assessed their understanding of the term “secondary tumor” or “second tumor”, and how they would interpret the terms “small chance” or “rare” in the context of a “bad side effect.”
Results
Twenty-nine percent of subjects correctly identified that “secondary tumors” referred to new and different tumors caused by treatment. Forty-nine percent thought the term referred to their original tumor recurring, and 22% thought the term referred to new and different tumors not caused by radiation therapy. Subjects with college degrees were not more likely to choose the correct answer than subjects without college degrees p=0.63. College degree status was not available for 5 subjects. Given choices between 1:10, 1:100, 1:1000, and 1:100,000, subjects associated “rare” with 1:1000 or 1:100,000 82% of the time. The term “small chance” was associated with 1:1000 or 1:100,000 59% of the time.
Conclusion
Adult non-cancer patients have a demonstrably different understanding than radiation oncologists of the terms “second tumor” or “secondary tumor.” Additionally, patient understanding of the terms “rare” or “small chance” varies from secondary malignancy incidences in many clinical scenarios. Radiation oncologists should use clearer terms for secondary malignancies and their incidence.

Survey of Informed Consent Procedures in Urology

Survey of Informed Consent Procedures in Urology
Juliana Kim, Arnav Srivastava, Alexandra Tabakin, Eric A Singer
Journal of the American College of Surgeons, November 2022; 235(5)
Abstract
Introduction
The American Urological Association and American College of Surgeons codes of professionalism require surgeons to disclose the specific roles and responsibilities of trainees to patients during the informed consent process. This study analyzes how these requirements are met by urology training programs.
Method
An anonymous electronic survey was distributed to the program directors (PDs) of the 143 ACGME urology residency programs in the US in 2021. Responses were procured during 3 months. Information was collected regarding program demographics, aspects of the program’s consent process, and the disclosure of the role and participation of residents to patients.
Result
Of 143 distributed surveys, 30.0% (n = 43) received a response. Of responding PDs, 67.4% reported that attending physicians lead the consent process. The topics covered during consent discussion include possible complications (25.1%), expected recovery time (22.8%), length of the surgery (22.2%), the people involved (18.0%), and their specific roles (7.2%). Of PDs, 48.8% and 87.8% of do not explicitly discuss trainee involvement or when a resident performs the majority of the case, respectively (Figure). Of PDs, 78.8% do not communicate medical student involvement. Of PDs, 73.2% reported having a patient decline participation of a trainee after describing their role.
Conclusion
Despite the American Urological Association and American College of Surgeons codes of professionalism, many urologists involved in the training of residents may not disclose resident participation in surgery to patients. Further discussions are needed to explore how to better balance resident education while strengthening the informed consent process.

How I Learned is How I Teach – Perspectives on How Faculty Surgeons Approach Informed Consent Education

How I Learned is How I Teach – Perspectives on How Faculty Surgeons Approach Informed Consent Education
Erin M. White, Andrew C. Esposito, Vadim Kurbatov, Xujun Wang, Michael G. Caty, Maxwell Laurans, Peter S. Yoo
Journal of Surgical Education, 15 October 2022
Abstract
Objective
To understand the variability of surgical attending experience and perspectives regarding informed consent and how it impacts resident education
Design
A novel survey was distributed electronically to explore faculty surgeon’s personal learning experience, knowledge, clinical practice, teaching preferences and beliefs regarding informed consent. Chi-square and Kruskal-Wallis testing was performed to look for associations and a cluster analysis was performed to elucidate additional patterns among.
Setting
Single, tertiary, university-affiliated health care system (Yale New Haven Health in Connecticut), including 6 teaching hospitals.
Participants
Clinical faculty within the Department of Surgery.
Results
A total of 85 surgeons responded (49% response rate), representing 17 specialties, both private practice and university and/or hospital-employed, with a range of years in practice. Across all ages, specialties, the most common method for both learning (86%) and teaching (82%) informed consent was observation of the attending. Respondents who stated they learned by observing attendings were more likely to report that they teach by having trainees observe them (OR 8.5, 95% CI 1.3-56.5) and participants who recalled learning by having attendings observe them were more likely to observe their trainees (OR 4.1, 95% CI 1.5-11.2).Cluster analysis revealed 5 different attending phenotypes with significant heterogeneity between groups. A cluster of younger attendings reported the least diverse learning experience and high levels of concern for legal liability and resident competency. They engaged in few strategies for teaching residents. By comparison, the cluster that reported the most diverse learning experience also reported the richest diversity of teaching strategies to residents but rarely allowed residents to perform consent with their patients. Meanwhile, 2 other cluster provided a more balanced experience with some opportunities for practice with patients and some diversity of teaching– these clusters, respectively, consist of older, experienced general surgeons and surgeons in trauma and/or critical care.
Conclusions
Surgeon’s demographics, personal experiences, and specialty appear to significantly influence their teaching styles and the educational experience residents receive regarding informed consent.

Informed consent for psychotherapy: Ethical illusion or clinical reality? A survey about psychotherapists’ attitudes and practices in Germany

Informed consent for psychotherapy: Ethical illusion or clinical reality? A survey about psychotherapists’ attitudes and practices in Germany
Leonie Gerke, Ann-Katrin Meyrose, Yvonne Nestoriuc
Clinical Psychology and Psychotherapy, 10 October 2022
Abstract
Objective
This study aimed to assess clinicians’ attitudes and their current clinical practices regarding informed consent for psychotherapy.
Method
A convenience sample of N = 530 clinicians in Germany (n = 418 licensed psychotherapists and n = 112 postgraduate psychotherapy trainees) took part in an online survey.
Results
Most clinicians (84%) reported obtaining informed consent for psychotherapy in their daily routine. However, many psychotherapists felt unsure about satisfactorily fulfilling the legal (63%) and ethical obligations (52%). The two most frequently reported components of information disclosure related to explaining the terms and conditions of psychotherapy (96%) and the psychotherapeutic approach (91%). Providing information about mechanisms of psychotherapy (33%) and the role of expectations (30%) were least practiced. One in five psychotherapists reported not informing clients about potential risks and side effects. A considerable proportion reported concern about inducing anxiety in patients by disclosing information about risks and side effects (52%).
Conclusions
Although obtaining informed consent for psychotherapy seems to be the rule rather than the exception in clinical practice, the quality of its implementation in terms of legal, ethical and clinical demands remains questionable. Training psychotherapists in providing comprehensive informed consent enables informed decision-making and might have a positive influence on treatment expectations and outcomes.

Subtotal Cholecystectomy Results in High Peri-operative Morbidity and Its Risk-Profile Should be Emphasised During Consent

Subtotal Cholecystectomy Results in High Peri-operative Morbidity and Its Risk-Profile Should be Emphasised During Consent
Original Scientific Report
James Lucocq, David Hamilton, John Scollay, Pradeep Patil
World Journal of Surgery, 8 October 2022
Open Access
Abstract
Background
Subtotal cholecystectomy aims to reduce the likelihood of bile duct injury but risks a multitude of less severe, yet significant complications. The primary aim of the present study was to report peri-operative outcomes of subtotal laparoscopic cholecystectomy (SLC) relative to total laparoscopic cholecystectomy (TLC) to inform the consent process.
Method
All laparoscopic cholecystectomies between 2015 and 2020 in one health board were included. The peri-operative outcomes of SLC (n = 87) and TLC (n = 2650) were reported. Pre-operative variables were compared between the two groups to identify risk factors for SLC. The outcomes between the SLC and TLC were compared using univariate, multivariate and propensity analysis.
Results
Risk factors for SLC included higher age, male gender, cholecystitis, increased biliary admissions, ERCP, cholecystostomy and emergency cholecystectomy. Following SLC, rates of post-operative complication (45.9%), imaging (37.9%) intervention (28.7%) and readmission (29.9%) were significant. The risk profile was vastly heightened compared to that of TLC: intra-operative complications (RR 9.0; p < 0.001), post-operative complications [bile leak (RR 58.9; p < 0.001), collection (RR 12.2; p < 0.001), retained stones (RR 7.2; p < 0.001) and pneumonia (RR 5.4; p < 0.001)], post-operative imaging (RR 4.4; p < 0.001), post-operative intervention (RR 12.3; p < 0.001), prolonged PLOS (RR 11.3; p < 0.001) and readmission (RR 4.5; p < 0.001). The findings were consistent using multivariate logistic regression and propensity analysis.
Conclusion
The relative morbidity associated with SLC is significant and high-risk patients should be counselled for the peri-operative morbidity of subtotal cholecystectomy.

Understanding consent for surgery and for treatment in orthopaedics

Understanding consent for surgery and for treatment in orthopaedics
Editorial
Vane Antolič, Marius M. Scarlat
International Orthopaedics, 30 September 2022; 46 pp 2459–2460
Open Access
Excerpt
Consenting to treatment implies that a person gives permission before receiving any type of medical care, test or examination. The Consent protects the doctor from the accusation of an “unwanted touch”. Surgery is a complex medical act involving treatments, acts, and manoeuvres that could be harmful, although they are expected to be beneficial and amend positively the patient’s health. Prior to obtaining consent for the proposed succession of acts, the surgeon must provide the patient with information about the nature of the treatment, the expected benefits, material risks and adverse effects, alternate treatments, and the consequences of not having the surgery. Consent for surgery has become a critical component of surgical practice and is of increasing importance and must be updated with patient and legal expectations. For consent to be valid, it must be voluntary and informed, and the person consenting must have the capacity to make the decision. The principle of consent is an important part of medical ethics and international human rights law.

Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations’ policies in England and Wales

Qualitative documentary analysis of guidance on information provision and consent for the introduction of innovative invasive procedures including surgeries within NHS organisations’ policies in England and Wales
Original research
Cynthia A Ochieng, Hollie Richards, Jesmond Zahra, Sian Cousins, Daisy Elliott, Nicholas Wilson, Sangeetha Paramasivan, Kerry N L Avery, Johnny Mathews, Barry G Main, Robert Hinchliffe, Natalie S Blencowe, Jane M Blazeby
BMJ Open, 1 September 2022
Open Access
Abstract
Objective
To review guidance, included in written local UK National Health Service (NHS) organisation policies, on information provision and consent for the introduction of new invasive procedures- including surgeries, and devices (IPs/Ds).
Design
A qualitative documentary analysis of data on patient information provision and consent extracted from policies for the introduction of IP/Ds from NHS organisations in England and Wales.
Setting
NHS trusts in England and health boards in Wales, UK.
Participants
Between December 2017 and July 2018, 150 acute trusts in England and 7 health boards in Wales were approached for their policies for the introduction of new IP/Ds. In total, 123 policies were received, 11 did not fit the inclusion criteria and a further policy was included from a trust website resulting in 113 policies included for review.
Results
From the 113 policies, 22 did not include any statements on informed consent/information provision or lacked guidance on the information to be provided to patients and were hence excluded. Consequently, 91 written local NHS policies were included in the final dataset. Within the guidance obtained, variation existed on disclosure of the procedure’s novelty, potential risks, benefits, uncertainties, alternative treatments and surgeon’s experience. Few policies stated that clinicians should discuss the existing evidence associated with a procedure. Additionally, while the majority of policies referred to patients needing written information, this was often not mandated and few policies specified the information to be included.
Conclusions
Nearly a fifth of all the policies lacked guidance on information to be provided to patients. There was variability in the policy documents regarding what patients should be told about innovative procedures. Further research is needed to ascertain the information and level of detail appropriate for patients when considering innovative procedures. A core information set including patients’ and clinicians’ views is required to address variability around information provision/consent for innovative procedures.

How readable are orthognathic surgery consent forms?

How readable are orthognathic surgery consent forms?
Original Article
Maurice J.Meade, Craig W. Dreyer
International Orthodontics, 16 September 2022
Summary
Background/objective
The valid consent process for medical intervention requires the disclosure of information in a format that is easily understandable by the patient. The aim of this investigation was to assess the readability of orthognathic surgery informed consent forms (OSICFs).
Methods
An online search methodology was conducted to identify OSICFs for analysis. The forms that satisfied inclusion/exclusion criteria were evaluated according to a standardised protocol. The readability of the content was assessed using three validated tools: the Simple Measure of Gobbledegook (SMOG) score, Flesch-Kincaid Grade-Level (FKGL) score and Flesch Reading Ease (FRE) score.
Results
Most of the 26 evaluated OSICFs were sourced from websites within the United States (69.2%) and from oral and maxillo-facial surgery practices (76.9%). Two of the assessed forms were template OSICFs available from oral and maxillo-facial professional societies to its members. The scores from the three tools found that the content of 84.6% to 92.3% of the forms were “difficult” to read. The mean (SD) SMOG score for all evaluated OSICFs was 12.31(2.22) [95% CI: 11.42 to 13.21]. The SMOG and FKGL scores were closely correlated (r = 0.99, P < 0.0001; 95% CI: 0.9864 to 0.9973). There was no association between SMOG scores and the number of words contained within each consent form (r = −0.047;95% CI: −0.44 to 0.36).
Conclusions
The OSICFs surveyed in this investigation failed to meet recommended readability levels. A significant number of patients are not likely to understand the information contained within the forms. Orthodontists are advised that poor literacy skills of their patients may preclude them from validly consenting to orthognathic surgery treatment procedures.

An evaluation of patient informed consent for dental extractions

An evaluation of patient informed consent for dental extractions
Richa Arya, Sarah Jadun, Aneesha Shah
Primary Dental Surgery, 7 September 2022; 11(3)
Abstract
Dental practitioners are well versed in informing patients of the risks and benefits associated with dental extractions. The purpose of this service evaluation was to determine whether patients understood and recalled information relevant to their planned oral surgery procedure, prior to second stage consent. A questionnaire was distributed to patients who were attending for their elective treatment appointment. This explored their ability to recall the planned intervention, the modality of treatment (local anaesthetic, intravenous sedation, or general anaesthetic), understanding of alternative treatment options and the risks associated with the procedure. Completed responses were received from 29 of the distributed questionnaires (response rate=58%). The majority of patients were not aware of the following risks with their procedure: pain, bleeding, bruising, swelling, infection, damage to adjacent structures. Despite a well-documented consent form and comprehensive discussion, we identified that patients may not comprehend or recollect the risks associated with their dental extraction. As dental professionals we have a duty to seek ways to facilitate patient understanding and maximise their autonomy.