ACR–ARS Practice Parameter on Informed Consent Radiation Oncology
Original Article
Hurwitz, Mark D., Chundury, Anupama, Goodman, Chelain R., Jones, Joshua, Lo, Simon S., Saeed, Hina, Small, William Jr, Schechter, Naomi R.
American Journal of Clinical Oncology, 8 March 2023
Abstract
Objectives
Consent is a communication process between the patient and a health care provider, in which both parties have the opportunity to ask questions and exchange information relevant to the patient’s diagnosis and treatment. The process of informed consent is designed to protect a patient’s autonomy in their medical decision-making in the context of an asymmetric relationship with the health care system. A proper consent process assures a patient’s individual autonomy, reduces the opportunity for abusive conduct or conflicts of interest, and raises trust levels among participants. This document was developed as an educational tool to facilitate these goals.
Methods
This practice parameter was produced according to the process described under the heading “The Process for Developing ACR Practice Parameters and Technical Standards” on the ACR website (https://www.acr.org/Clinical-Resources/Practice-Parameters-and-Technical-Standards) by the Committee on Practice Parameters—Radiation Oncology of the ACR Commission on Radiation Oncology in collaboration with the ARS. Committee members were charged with reviewing the prior version of the informed consent practice parameter published in 2017 and recommending additions, modifications, or deletions. The committee met through remote access and subsequently through an online exchange to facilitate the development of the revised document. Focus was given on identifying new considerations and challenges with informed consent given the evolution of the practice of radiation oncology in part driven by the COVID-19 pandemic and other external factors.
Results
A review of the practice parameter published in 2017 confirmed the ongoing relevance of recommendations made at that time. In addition, the evolution of the practice of radiation oncology since the publication of the prior document resulted in the need for new topics to be addressed. These topics include remote consent either through telehealth or telephone and with the patient or their health care proxy.
Conclusions
Informed consent is an essential process in the care of radiation oncology patients. This practice parameter serves as an educational tool designed to assist practitioners in optimizing this process for the benefit of all involved parties.

Evidence-based informed consent form for total knee arthroplasty
Methodology
Satvik N. Pai, Madhan Jeyaraman, Nicola Maffuli, Naveen Jeyaraman, Filippo Migliorini, Ashim Gupta
Journal of Orthopaedic Surgery and Research, 2 March 2023
Open Access
Abstract
Introduction
Informed consent documentation is often the first area of interest for lawyers and insurers when a medico-legal malpractice suit is concerned. However, there is a lack of uniformity and standard procedure about obtaining informed consent for total knee arthroplasty (TKA). We developed a solution for this need for a pre-designed, evidence-based informed consent form for patients undergoing TKA.
Materials and methods
We extensively reviewed the literature on the medico-legal aspects of TKA, medico-legal aspects of informed consent, and medico-legal aspects of informed consent in TKA. We then conducted semi-structured interviews with orthopaedic surgeons and patients who had undergone TKA in the previous year. Based on all of the above, we developed an evidence-based informed consent form. The form was then reviewed by a legal expert, and the final version was used for 1 year in actual TKA patients operated at our institution.
Results
Legally sound, evidence-based Informed Consent Form for Total Knee Arthroplasty.
Conclusion
The use of legally sound, evidence-based informed consent for total knee arthroplasty would be beneficial to orthopaedic surgeons and patients alike. It would uphold the rights of the patient, promote open discussion and transparency. In the event of a lawsuit, it would be a vital document in the defence of the surgeon and withstand the scrutiny of lawyers and the judiciary.

Patient Information and Consent for Care in the Intensive Care Unit
Review
Jean-Philippe Rigaud, Fiona Ecarnot, Jean-Pierre Quenot
Healthcare, 27 February 2023; 11(5)
Abstract
In this paper, we review the ethical issues involved in providing information to, and obtaining consent (for treatment and/or research) from patients in the intensive care unit. We first review the ethical obligations of the physician in treating patients, who are by definition, vulnerable, and often unable to assert their autonomy during situations of critical illness. Providing clear and transparent information to the patient about treatment options or research opportunities is an ethical and, in some cases, legal obligation for the physicians, but may be rendered difficult, not to say impossible in the intensive care unit by the patient’s health state. In this context, we review the specificities of intensive care with respect to information and consent. We discuss who the right contact person is in the ICU setting, with possible choices including a surrogate decision maker, or a member of the family, in the absence of an officially designated surrogate. We further review the specific considerations relating to the family of critically ill patients, and the amount and type of information that may be given to them without breaching the tenets of medical confidentiality. Finally, we discuss the specific cases of consent to research, and patients who refuse care.

Informed consent in episiotomy: Co-analysis with midwives and distillation of best practice
Jennifer MacLellan, Sara S. Webb, Carmen Byrne, Emily Brace, Elizabeth Glyn-Jones, Elizabeth Edwards, Tracey Hunter, Jacqueline Longton, Jane Cleary, Katie Christie, Lorna Dow, Jo Gould
Birth, 16 February 2023
Open Access
Abstract
Background
Performing an episiotomy where clinically indicated is a key intervention in the Obstetric Anal Sphincter Injury Care Bundle (OASI-CB) implemented across England and Wales to reduce the risk and increase the detection of severe perineal trauma after birth. Standards of consent provided to people in maternity care generally and for episiotomy specifically have been reported as suboptimal. Compromising birthing people’s personal autonomy or sense of control has been linked to a dissatisfying birth experience, negative psychological sequelae, and litigation.
Methods
This study explored experienced midwives’ practice of informed consent for episiotomy during a midwife-led birth. We sampled 43 midwives across eight NHS Trusts in England and Wales using online focus groups and telephone interviews about their experience of consent in episiotomy. Using qualitative content analysis and art-based co-analysis methods with eight midwives from across the research sites, we co-analyzed and co-constructed three themes and four practice recommendations from the data.
Results
Three themes were constructed from the data: Assent rather than consent, Change in culture to support best practice, and Standardized information. These themes informed the shaping of four recommendations for best practice in episiotomy informed consent.
Conclusion
This study has shown how variations in midwifery practice and culture may impact birthing people’s experience of informed consent in episiotomy. Midwives may not have the knowledge or skills to conduct a detailed consent conversation, leading to variation in practice and messages for birthing people. The use of antenatal discussion aids can offer women the opportunity to become informed and fully participate in the decision-making process.

A Well-understood Surgical Informed Consent: A Scoping Review
Rieke Cahya, Adik Wibowo
Unnes Journal of Public Health, January 2023
Open Access
Abstract
The implementation of surgical consent has shifted from simply getting a signature to a focus on doctor-patient communication. Providing adequate information is very important for patients in making decisions so that patients voluntary agree to medical action. Understanding of the medical information that has been provided is the basis for patients to give consent, but in reality many patients find it difficult to understand and doctor fail to administer proper information.The purpose of this scoping review are to evaluate patient’s understanding of the standard surgical informed consent prosess or those given by other methods and to identify factors that influence this patient’s understanding. Three electronic database (ProQuest, ScienceDirect, and Scopus) were used to search literature from 2017 until 2022. A total of 391 articles were identified and 25 articles were selected according to the PRISMA guidelines and the PCC framework. 9 of 11 articles stated that patient understanding level was low. Factors that influence it include education background, age and language limitations. 12 studies (85%) showed that patient understanding improved with the use of additional information media. Overall, the patient’s understanding of surgical informed consent is still low. Communication between doctor and patient plays a big role in it. Various interventions to improve the communication process can be used to improve patient understanding.

Editor’s note: Unnes Journal of Public Health is published by Universitas Negeri Semarang (UNNES) in cooperation with the Association of Indonesian Public Health Experts.

Surgical Informed Consent: A Scoping Review of Physician-facing Decision Support Tools
Review
Alexa D. Melucci, Mariah R. Erlick, Anthony Loria, Marcia M. Russell, Larissa K. Temple, Gabriela C. Poles
Annals of Surgery Open, March 2023; 4(1)
Abstract
Objectives
Physician-facing decision support tools facilitate shared decision-making (SDM) during informed consent, but it is unclear whether they are comprehensive in the domains they measure. In this scoping review, we aimed to (1) identify the physician-facing tools used during SDM; (2) assess the patient-centered domains measured by these tools; (3) determine whether tools are available for older adults and for use in various settings (elective vs. emergent); and (4) characterize domains future tools should measure.
Methods
Using the Preferred Reporting Items for Systematic Reviews and Meta-analyses extension for Scoping Reviews, Embase, Medline, and Web of Science were queried for articles published between January 2000 and September 2022. Articles meeting inclusion criteria underwent title and abstract review. Eligible studies underwent data abstraction by two reviewers.
Results
Of 4365 articles identified, 160 were eligible. Tools to aid in surgical SDM focus on elective procedures (79%) and the outpatient setting (71%). Few tools are designed for older adults (5%) or for nonelective procedures (9%). Risk calculators were most common, followed by risk indices, prognostic nomograms, and communication tools. Of the domains measured, prognosis was more commonly measured (85%), followed by alternatives (28%), patient goals (36%), and expectations (46%). Most tools represented only one domain (prognosis, 33.1%) and only 6.7% represented all four domains.
Conclusions and Implications
Tools to aid in the surgical SDM process measure short-term prognosis more often than patient-centered domains such as long-term prognosis, patient goals, and expectations. Further research should focus on communication tools, the needs of older patients, and use in diverse settings.

Factors impacting informed consent in cosmetic breast augmentation
Stephen Whyte, Laura Bray, Martin Brumpton, Ho Fai Chan, Tim S. Peltz, Manisha Tamar, Uwe Dulleck, Dietmar W. Hutmacher
The Breast, 22 February 2023
Open Access
Abstract
Background
For women who undergo cosmetic breast augmentation, their post-operative risk assessment may not match their pre-operative understanding of the involved risks and likelihood of revision surgeries. This may be due to the potential issues surrounding whether patients are being fully informed about all possible risks and related financial implications during the consent phases of patient/doctor consultation.
Methods
To explore comprehension, risk preference, and perceptions of breast augmentation procedure, we conducted a recorded online experiment with 178 women (18–40 years) who received varying amounts of risk-related information from two experienced breast surgeons in a hypothetical first consultation scenario.
Results
We find patient’s age, self-rated health, income, education level, and openness to experience to be significant factors impacting initial breast augmentation risk preferences (before receiving any risk information). Further, more emotionally stable patients perceived greater breast augmentation risks, were less likely to recommend breast augmentation, and were more likely to acknowledge the likelihood for future revision surgery. After providing women with risk-related information we find increases in risk assessment in all treatment conditions, and that increased amounts of risk information do decrease women’s willingness to recommend breast augmentation. But that increased risk information does not appear to increase women’s assessment of the likelihood of future revision surgery. Finally, we find some participant individual differences (such as education level, having children, conscientiousness and emotional stability) appear to impact risk assessment post receiving risk information.
Conclusion
Continuous improvement of the informed consent consultation process is vital to optimising patient outcomes efficiently and cost-effectively. Greater acknowledgement and emphasis on disclosure of related risks and financial burden when complications arise is also important. As such, future behavioural research is warranted into the factors impacting women’s understanding both prior to and across the BA informed consent process.

A randomized controlled trial of patient recall after detailed written consent versus standard verbal consent in adults with routine orthopaedic trauma
Amjad M. Aslam, James Kennedy, Haider Seghol, Nikhil Khisty, Thomas A. Nicols, Sam Adie
Bone & Joint Open, 20 February 2023; 4(2) pp 104–109
Open Access
Abstract
Aims
Patient decision aids have previously demonstrated an improvement in the quality of the informed consent process. This study assessed the effectiveness of detailed written patient information, compared to standard verbal consent, in improving postoperative recall in adult orthopaedic trauma patients.
Methods
This randomized controlled feasibility trial was conducted at two teaching hospitals within the South Eastern Sydney Local Health District. Adult patients (age ≥ 18 years) pending orthopaedic trauma surgery between March 2021 and September 2021 were recruited and randomized to detailed or standard methods of informed consent using a random sequence concealed in sealed, opaque envelopes. The detailed group received procedure-specific written information in addition to the standard verbal consent. The primary outcome was total recall, using a seven-point interview-administered recall questionnaire at 72 hours postoperatively. Points were awarded if the participant correctly recalled details of potential complications (maximum three points), implants used (maximum three points), and postoperative instructions (maximum one point). Secondary outcomes included the anxiety subscale of the Hospital and Anxiety Depression Scale (HADS-A) and visual analogue scale (VAS) for pain collected at 24 hours preoperatively and 72 hours postoperatively. Additionally, the Patient Satisfaction Questionnaire Short Form (PSQ-18) measured satisfaction at 72 hours postoperatively.
Results
A total of 60 patients were randomized, 32 to the standard group and 28 to the detailed group. Patients in the detailed group had significantly higher total recall score compared to the standard group (mean difference 1.29 points (95% confidence interval (CI) 0.51 to 2.08); p = 0.002). There were no differences in HADS-A (mean difference 0.39 (95% CI -2.11 to 2.88); p = 0.757), VAS pain (mean difference 5.71 (95% CI -22.25 to 11.11); p = 0.499), or PSQ-18 (mean difference 0.499; 95% CI -1.6 to 3.42; p = 0.392).
Conclusion
Detailed written tools are useful in improving postoperative recall in adult orthopaedic trauma patients.

Consent during labour and birth as observed by midwifery students: A mixed methods study
Nigel Lee, Lauren Kearney, Emma Shipton, Glenda Hawley, Peta Winters-Chang, Catherine Kilgour, Susannah Brady, Ann Peacock, Loretta Anderson, Tracy Humphrey
Women and Birth, 18 February 2023
Open Access
Abstract
Background
While consent is an integral part of respectful maternity care, how this is obtained during labour and birth presents conflicting understandings between midwives’ and women’s experiences. Midwifery students are well placed to observe interactions between women and midwives during the consent process.
Aim
The purpose of this study was to explore the observations and experiences of final year midwifery students of how midwives obtain consent during labour and birth.
Methods
An online survey was distributed via universities and social media to final year midwifery students across Australia. Likert scale questions based on the principles of informed consent (indications, outcomes, risks, alternatives, and voluntariness) were posed for intrapartum care in general and for specific clinical procedures. Students could also record verbal descriptions of their observations via the survey app. Recorded responses were analysed thematically.
Findings
225 students responded with 195 completed surveys; 20 students provided audio recorded data. Student’s observations suggested that the consent process varied considerably depending on the clinical procedure. Discussions of risks and alternatives during labour were frequently omitted.
Discussion
The student’s accounts suggest that in many instances during labour and birth the principles of informed consent are not being applied consistently. Presenting interventions as routine care subverted choice for women in favour of the midwives’ preferences.
Conclusions
Consent during labour and birth is invalidated by a lack of disclosure of risks and alternatives. Health and education institutions should include information in guidelines, theoretical and practice training on minimum consent standards for specific procedures inclusive of risks and alternatives.

Consent for Trainee Participation in Abortion Care: A Qualitative Study of Patient Experiences & Preferences in the United States
Lara Crystal-Ornelas, Shashi Sarnaik, Shokoufeh Dianat, Christine Dehlendorf, Kelsey Holt
Contraception, 8 February 2023
Abstract
Objectives
Abortion training for clinicians is crucial to ensure patients’ future access to full spectrum reproductive health care. Given the complex sociopolitical context of abortion, consent to allow a trainee’s involvement in abortion care requires careful attention to avoid harm to patients while also ensuring adequate clinician training for the future provision of care. In order to inform the development of patient-centered recommendations, we assessed patient experiences and preferences around consent for trainee participation during abortion care.
Study design
We interviewed participants who received abortion care at sites with medical trainees in the United States (US). We conducted interviews via zoom (video-off) between August 2021 and January 2022. We audio-recorded and transcribed the interviews. We coded transcripts using NVivo software and analyzed inductively using thematic analysis.
Results
Twenty-four (n=24) participants reflected a diverse range of socio-demographics as well as location of abortion service. Some reported experiences of coercion related to trainee involvement, ranging from subtle to overt. Participants preferred consent for trainee involvement in abortion care be a process outside the procedure room, while clothed, without the trainer or trainee present to allow for time to consider options without pressure to say yes.
Conclusions
Patient-centered approaches to seeking consent for trainee involvement in abortion care must reduce potential for coercion. A standardized consent before the procedure room by a trained staff member without the trainer or trainee present can help prioritize patient autonomy. Understanding care team member roles and upholding confidentiality and privacy are paramount to patients feeling safe with trainees present.