Surgical Informed Consent: A Scoping Review of Physician-facing Decision Support Tools
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)
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.
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.
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
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.
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.
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.
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
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.
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.
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).
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
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
Assessment of the Factors Influencing the Patient’s Comprehension of the Informed Consent to Interventional Pain Procedures
Mohammad Ghorbanhoseini, Kyle Kang, Allen Yang, Mohammadreza Abbasian, Eduard Vaynberg
Pain Research and Management, 8 February 2023
Informed consent is the first step of every medical procedure and is considered a standard of care for patients undergoing medical interventions. Our study seeks to evaluate patients’ understanding of the procedure they consented to and the factors affecting the degree of understanding.
In this cross-sectional study, we used an anonymous postprocedural questionnaire to assess our patients’ understanding of the procedure being performed and their level of satisfaction. It was conducted between June 2021 and January 2022 on every consenting patient who declined English interpreter services and was undergoing a first elective lumbar epidural steroid injection.
The mean age of 201 subjects was 57.3 (23–90) years, with a race distribution of Black (44.3%), White (31.8%), and other races (23.9%). 15.9% of our subjects worked in the medical field. Older age and patients identified as Black and other races had a positive correlation with the propensity to predict a poor understanding of consent. This study failed to demonstrate any difference in understanding of informed consent content between the different subgroups when stratified by assigned sex at birth, level of education, and profession. Patients’ expectation from the treatment was classified as desperate (will take any help they can) in 78 patients (38.8%), feeling hopeful (expecting partial improvement in their symptoms) in 52 patients (25.9%), and being optimistic (will obtain full recovery from this injection) in 71 patients (35.3%). 192 patients (95.5%) were very satisfied with the consent process. Seven patients (3.5%) stated that they wanted more information, and 2 patients (1.0%) did not understand the explanation. 180 patients (89.6%) were satisfied with the overall experience, while 21 patients (10.4%) were not. The Wilks test (likelihood-ratio test) resulted in a value of 0.023 and was deemed statistically significant for a relationship between understanding of consent and the satisfaction of the patient from the procedure.
Although patients carry a variable expectation of procedures, most patients in our pain clinic have a high level of satisfaction despite having a poor understanding of the procedure provided via informed consent. Although our patients’ level of objective comprehension is low, those with a better understanding of the procedure tend to have a more satisfactory experience.
Informed or misinformed consent and use of modified texture diets in dysphagia
Shaun T. O’Keeffe, Paula Leslie, Tracy Lazenby-Paterson, Arlene McCurtin, Lindsey Collins, Aoife Murray, Alison Smith, Siofra Mulkerrin
BMC Medical Ethics, 7 February 2023; 24(7)
Use of modified texture diets—thickening of liquids and modifying the texture of foods—in the hope of preventing aspiration, pneumonia and choking, has become central to the current management of dysphagia. The effectiveness of this intervention has been questioned. We examine requirements for a valid informed consent process for this approach and whether the need for informed consent for this treatment is always understood or applied by practitioners.
Valid informed consent requires provision of accurate and balanced information, and that agreement is given freely by someone who knows they have a choice. Current evidence, including surveys of practitioners and patients in different settings, suggests that practice in this area is often inadequate. This may be due to patients’ communication difficulties but also poor communication—and no real attempt to obtain consent—by practitioners before people are ‘put on’ modified texture diets. Even where discussion occurs, recommendations may be influenced by professional misconceptions about the efficacy of this treatment, which in turn may poison the well for the informed consent process. Patients cannot make appropriate decisions for themselves if the information provided is flawed and unbalanced. The voluntariness of patients’ decisions is also questionable if they are told ‘you must’, when ‘you might consider’ is more appropriate. Where the decision-making capacity of patients is in question, inappropriate judgements and recommendations may be made by substitute decision makers and courts unless based on accurate information.
Research is required to examine the informed consent processes in different settings, but there is ample reason to suggest that current practice in this area is suboptimal. Staff need to reflect on their current practice regarding use of modified texture diets with an awareness of the current evidence and through the ‘lens’ of informed consent. Education is required for staff to clarify the importance of, and requirements for, valid informed consent and for decision making that reflects people’s preferences and values.
Informed consent research at a tertiary hospital: How impactful is competency in simpler versus standard consent forms for intravitreal injection therapy?
Hamidu Hamisi Gobeka, Yiğit Şenol, Saadet Alijanli, Mustafa Doğan, İbrahim Ethem Ay
Journal of Clinical Medicine of Kazakhstan, February 2023
To compare the impact of competency in intravitreal injection therapy (IVIT)-related simpler versus standard consent forms (CFs).
Material and methods
Four hundred patients scheduled for IVIT in a tertiary hospital were enrolled between April 1, 2022 and June 30, 2022. These patients were eligible for the study if they had their first IVIT in one eye; those scheduled for IVIT in the other eye were not. Data, including age, gender, educational level, whether the patient was admitted alone or with a companion, and prior IVIT status were collected. A trained clinic secretary first gave the patients the commonly used standard CFs, followed by simpler CFs.
The mean age was 66.10±9.90 years. 93.80% had previously received IVIT. 53.80% of the patients consented on their own. While 98.00% consented without reading standard CFs, 56.00% consented after reading simpler CFs (p<0.001). The need for IVIT-related extra information and the desire against having IVIT were significantly higher in simpler than standard CFs (p<0.001). 5.00% of those who approved IVIT without reading both forms were illiterate, and 29.20% had vision issues. The probability of simpler CF reading increased by 4.653 and 7.510 times in high school and university graduates, respectively, relative to primary school graduates.
Simpler CFs had a much higher reading rate, which was linked to a higher rate of patients opting against IVIT. In medical fields like ophthalmology, where many procedures and research are performed, ethically approved informed consent requires consideration of patients’ education and prior treatment experience.
The ethics of consent during labour and birth: episiotomies
Marit van der Pijl, Corine Verhoeven, Martine Hollander, Ank de Jonge, Elselijn Kingma
Journal of Medical Ethics, 30 January 2023
Unconsented episiotomies and other procedures during labour are commonly reported by women in several countries, and often highlighted in birth activism. Yet, forced caesarean sections aside, the ethics of consent during labour has received little attention. Focusing on episiotomies, this paper addresses whether and how consent in labour should be obtained. We briefly review the rationale for informed consent, distinguishing its intrinsic and instrumental relevance for respecting autonomy. We also emphasise two non-explicit ways of giving consent: implied and opt-out consent. We then discuss challenges and opportunities for obtaining consent in labour and birth, given its unique position in medicine. We argue that consent for procedures in labour is always necessary, but this consent does not always have to be fully informed or explicit. We recommend an individualised approach where the antenatal period is used to exchange information and explore values and preferences with respect to the relevant procedures. Explicit consent should always be sought at the point of intervening, unless women antenatally insist otherwise. We caution against implied consent. However, if a woman does not give a conclusive response during labour and the stakes are high, care providers can move to clearly communicated opt-out consent. Our discussion is focused on episiotomies, but also provides a useful starting point for addressing the ethics of consent for other procedures during labour, as well as general time-critical medical procedures.
“Your Child Needs Surgery”: A Survey-Based Evaluation of Simulated Expert Consent Conversations by Key Stakeholders
Zoe Atsaidis, Stephan Robitaille, Elena Guadagno, Jeffrey Wiseman, Sherif Emil, Dan Poenaru
Journal of Pediatric Surgery, 24 January 2023
Consent conversations in pediatric surgery are essential components of pre-operative care which, when inadequate, can lead to significant adverse consequences for the child, parents, surgeon, and others in the healthcare system. The aim of this study is to explore expert consenting practice from the key stakeholders’ perspective.
Four senior attending pediatric surgeons obtained consent from a standardized mother of a child requiring surgery in two scenarios: a low-risk elective surgery (inguinal hernia repair – Video 1), and a high-risk emergency surgery (intestinal atresia – Video 2). All sessions were recorded. Families of children who had undergone minor or major surgery, families without medical or surgical background, and healthcare professionals were invited to view and evaluate the videos using a semi-structured questionnaire.
Out of 251 distributed surveys, 56 complete responses were received. Thirty two participants (57.1%) evaluated video 1 and 24 (42.9%) evaluated. Overall, 22 (69%) respondents to video 1 and 20 (84%) respondents to video 2 were “very satisfied” with the recorded consent conversation. Qualitative responses shared common themes of valuing surgeon empathy, good surgeon communication, patient engagement, and adequate time and information. Suggestions for improvement included additional resources and visual aids, improved patient engagement, and discussion of post-operative expectations.
Our data identifies strengths and gaps in the current consent process from the perspective of patient families and providers. Identified areas for improvement in the informed consent process based on multi-stakeholder input will guide the planned development of a consenting educational video resource.