Consent for trainee participation in abortion care: A clinical survey
Lara Crystal-Ornelas, Jessica Ma, Kelsey Holt, Christine Dehlendorf
The Annals of Family Medicine, 20 April 2022
Abortion care is an essential form of primary healthcare and is included in primary care medical training. Obtaining informed consent for trainee involvement in abortion care requires careful attention to avoid harm for patients while ensuring adequate training for the future provision of healthcare. Policies and practices related to obtaining this consent have not previously been documented; doing so has the potential to inform the development of future guidelines.
To identify current clinical practices, policies, and perspectives related to informed consent for trainee participation in abortion care.
Cross-sectional study using a REDCap survey.
Abortion clinics training medical students and Family Medicine (FM) and/or Obstetrics and Gynecology (OBGYN) residents.
Surveys were disseminated via email to directors of resident abortion training programs, with 46 responses (one per site) were collected in total. Of these sites, 67% were located in large cities, 44% were ambulatory care clinics within hospitals, and 20% were resident primary care clinics. The most common trainees at these sites were OBGYN residents (83%), medical students (70%), and FM residents (30%).
Just under half – 48% – reported their site has an informed consent form that mentions trainee involvement in abortion care, while 52% reported no mention of trainee involvement in their forms. With respect to policy, 65% reported their site has a general policy for trainee involvement in healthcare while 15% reported having no such policy. Notably, 20% reported not knowing whether such a policy exists. While 46% expressed the belief that asking patients specifically about trainee involvement in abortion care is very or extremely important, 80% of respondents reported that their clinical site does not provide training on obtaining this consent. Answers varied widely as to who conducts consent for trainee involvement and when consent occurs.
Survey responses illustrated a wide variability in clinical practices and perspectives around consent for trainee involvement in abortion care. Given the sensitive and stigmatized nature of abortion care, guidelines for the consent process can ensure that patient needs are met and their autonomy respected. Research is needed to assess patient perspectives to inform the development of these guidelines.
Informed Consent in Endoscopy: Read, Understood or Merely Signed
A.C. Carvalho, R. Cardoso, F. Pires, S. Ventura, C. Rodrigues, Â. Domingues, J. Pinho, D. Martins, P. Sousa, R. Araújo, E. Cancela, A. Castanheira, P. Ministro, M. Vieira, A. Silva
Endoscopy, 14 April 2022; 54(S01)
While informed consent is a requirement for all invasive procedures such as those in gastrointestinal endoscopy, its standardization is a challenge. Recently, our national digestive endoscopy society developed proposals for informed consent forms and information leaflets for esophagogastroduodenoscopy and colonoscopy. The main objective was to evaluate if patients read and understood these documents.
Adult patients proposed for elective esophagogastroduodenoscopy and colonoscopy and who were able to give their informed consent were included. Informed consent forms and information leaflets were sent to patients, with a small text instruction added to the body of the informed consent form. Prior to endoscopy it was assessed whether patients adequately read the informed consent form, based on 3 criteria: patient signature, table questionnaire completion and performance of the text instruction.
In total, 184 patients were included: 80 women and 104 men with a mean age of 63.6±12.4 years. Most had only basic education (77.2%) and had previously undergone an endoscopy (91.8%). 157 patients stated they had read the form (85.3%), while 27 (14.7%) did not. While most signed the form (141, 76.6%), only 46 patients (25.0%) met all 3 criteria for adequate reading and comprehension. No statistically significant association between informed consent form adequate reading and any of the assessed variables was found.
Most patients do not adequately read informed consent forms. Infographic strategies can direct patients’ attention and may improve these results, but they are no substitute of an effective doctor-patient relationship in obtaining informed consent.
Use and Perceptions of Shared Decision-Making by General Surgery Faculty and Trainees
Maham Javaid, Melanie Fritz, Mollie O’Brien, Sunday Clark, Suzanne Mitchell, Sabrina E. Sanchez
Journal of Surgical Research, 10 March 2022; 276 pp 323-330
The purpose of this study was to assess the practice and perceptions of shared decision-making (SDM) by both faculty and residents at Boston Medical Center and explore barriers and facilitators to implementing SDM at our institution.
We created and distributed an online survey assessing provider demographic and training characteristics, experiences with the informed consent process, practices in SDM, and perceptions about SDM. We used descriptive statistics to summarize provider characteristics and survey responses and univariate analysis to determine associations between them.
Fifteen surgeons and 19 surgical residents completed the survey (49% response rate). Most respondents were aware of and had a positive attitude toward SDM (91% and 76%, respectively); 35% reported having SDM training. Providers had varying levels of engagement with different SDM practices, and there were inconsistent associations between provider characteristics and the use of SDM. Often providers thought the patient’s health literacy, foreign primary language, clinical condition, and socioeconomic factors were barriers to the SDM process.
Although most general surgery faculty and residents at our institution had a positive view of SDM, they engaged in SDM behaviors inconsistently, with no clear association between clinician characteristics and specific behaviors. We identified several barriers to SDM consistent with those identified by providers in other specialties. This highlights the need for further research to study live general surgery provider-patient interactions, as well as structured SDM education to train general surgery providers to reliably engage their patients in effective SDM.
Procedure and Informed Consent of Patients for Capsule Endoscopy
Byung Ik Jang
Small Intestine Disease, 5 April 2022; pp 79-82 [Springer]
Capsule endoscopy allows the intestinal mucosa of patient to be examined without discomfort after a patient swallows the capsule for small intestinal examination. When conducting capsule endoscopy for diagnosing small intestinal disease, medical staffs must be fully aware of the entire procedures to ensure quality of capsule endoscopy and improvement of diagnosis. When conducting capsule endoscopy, patients must be fully informed of the preparation process before examination, the endoscopy itself and provisions after the examination. After being informed of all needed information, patients can then sign the consent for capsule endoscopy.
Awareness on consent and counselling among patients attending tertiary care hospitals : a cross-sectional study
S. Rao, P. Sagar, B. V. S. R. Kumari
Sri Lanka Journal of Surgery, 31 March 2022
Surgical consent and counselling are an integral part of medical practice and medical education. This study was done to know how many of the residents provide complete and accurate information to the patient during their training period.
Sixty residents from various surgical departments and 40 patients who were undergoing surgery were selected. The data was collected through interviews using two different questionnaires. The resident’s questionnaire provided the information they provide to patients. The patient’s questionnaire provided information on the level of their understanding from the interaction. Data were analysed using coGuide.
Out of 60 residents, 56(92 %) reported that the side effects and consequences were explained fully. 25% of residents mentioned the name of the surgery and nearly 100% did not mention the operating surgeon’s or unit in charge name. About 79% of residents felt that the patient was convinced with their way of communication, nearly 93 % of patients were convinced their disease process was explained well and 50% felt that the doctor informed the consequences of surgery well. 75% responded that doctor did not inform about the side-effects 98% were not aware of the alternative forms of treatment and, 87% of patients were not informed about the chances of recurrence of disease where ever applicable.
The majority of residents were convinced that their conveying skills are adequate for surgical counselling but they felt the need to improve. The majority of patients denied discussing complications when occurred.
Toolkit for the management of breast implants and the importance of Informed educated consent
Anand K Deva, Mark Ashton
Australasian Journal of Plastic Surgery, 31 March 2022; 5(1)
Breast implants have had a long and chequered history of periodic regulatory activity and class actions and are associated with significant medium and long term health risks, including the development breast implant associated anaplastic large cell lymphoma (BIA-ALCL). NSW Health through the Agency of Clinical Innovation has just released a toolkit for the management of breast implants. These are the result of collaborative clinical consensus across leaders in plastic and reconstructive surgery, breast surgery and radiology with support from the Surgical Services Taskforce and evidence directorate of the agency. Input was also sought from health consumers to ensure that the language and structure of the information was both comprehensive and accessible to women who were either considering either cosmetic augmentation or reconstruction and/or have breast implants in place.
Patient Satisfaction with Informed Consent for Cesarean and Operative Vaginal Delivery
Karen S. Levy, Martha K. Smith, Meagan Lacroix, Mark H. Yudin
Journal of Obstetrics and Gynaecology Canada, 29 March 2022
To evaluate patient satisfaction with the informed consent process for elective cesarean delivery (CD), emergency CD, and operative vaginal delivery (OVD).
A cross-sectional, survey-based study was conducted among patients on the postpartum floor of our institution. Patients were approached after delivery to complete a previously pilot-tested questionnaire, based on validated literature. One hundred eighty-four surveys were included in the analysis. Levels of patient satisfaction were compared across modes of delivery using χ2 tests of independence. Secondary objectives included evaluating the relationship between satisfaction scores and the patient’s recall of the consent process and emotional state during the consent process.
A significant association was found between patient satisfaction with the consent process and mode of delivery (P < 0.001). Those in the elective and emergency CD groups were significantly more likely to express high rates of satisfaction compared with those in the OVD group (odds ratio [OR] 9.03; 95% CI 2.80–29.10 and OR 3.97; 95% CI 1.34–11.76, respectively). High levels of satisfaction were significantly more common among those who had greater recall of the consent process (OR 25.2; 95% CI 7.34–87.04) and those who reported low levels of distress during the process (OR 15.1; 95% CI 4.70–48.66).
Informed consent during OVD is associated with lower rates of patient satisfaction compared with CD. Efforts are needed to improve the consent process for OVD to increase patient satisfaction and promote patient-centred care.
The Consent Process for Elective Hip and Knee Arthroplasty: Does Information on Handwritten Forms Meet Prescribed Standards?
Anirudh Sharma, Osasumwen Adelowo, Santosh Bindumadhavan, Naufal Ahmed, Amir-Reza Jenabzadeh
Cureus, 28 March 2022; 14(3)
The process of informed consent is vital, not only to good clinical practice and patient care, but also to avoid negligence and malpractice claims. Elective hip and knee arthroplasty numbers are increasing globally, and the British Orthopaedic Association (BOA) has endorsed standards for obtaining written consent for these procedures. Many centres in the United Kingdom and globally, use handwritten consent forms to document informed consent, leaving open the potential for missing out important procedure and risk-related information. Our study aimed to assess whether information on handwritten consent forms was compliant with BOA standards for elective arthroplasty of the hip and knee.
We retrospectively reviewed 70 handwritten consent forms, across theatre lists of 12 arthroplasty consultants at our elective arthroplasty centre. These included 35 forms each for hip and knee arthroplasty respectively. We compared the information on these forms to the standards prescribed by the BOA. We assessed compliance of the forms with common, less common and rare risks of hip and knee replacement, as described by the BOA. We also noted the designation of the person filling out the form (consultant, registrar or nurse practitioner) and whether this affected information on the form. We assessed the forms for legibility issues, and whether the setting (clinic/pre-operative ward) affected information on the form.
None of the 70 forms reviewed achieved full compliance with BOA standards. When assessed for common risks of hip and knee arthroplasty, the number of compliant forms was 25.7% and 42.8%, respectively. None of the forms mentioned all rare risks of either hip or knee arthroplasty. We identified legibility issues in 12 of 70 (17.1%) forms. There was no significant difference in information written on forms filled out by consultants, registrars or nurse practitioners, or between forms filled out in the clinic versus those on the pre-operative ward.
Handwritten forms lack compliance with prescribed standards for written informed consent in elective hip and knee arthroplasty. Ideally, a pre-written consent form should be used, but with the option of adding information individually tailored to the patients’ background. This ensures that good clinical practice is optimally followed, and reduces the potential risk of any litigation.
Informed Consent is Poorly Documented when Obtaining Toxicology Testing at Delivery in a Massachusetts Cohort
Kathleen J.Koenigs, Joseph H. Chou, Samuel Cohen, Moira Nolan, Gina Liu, Mishka Terplan, Brian M. Cummings, Timothy Nielsen, Nicole A. Smith, Joseph Distefano, Sarah N. Bernstein, Davida M. Schiff
American Journal of Obstetrics & Gynecology MFM, 27 March 2022
Positive toxicology testing at delivery can have enormous consequences for birthing persons and their families, including charges of child abuse/neglect and potential loss of custody for the birthing parent. State and national guidelines therefore stipulate clinicians should obtain consent prior to toxicology testing at delivery.
We examined: (1) clinician documentation of patient consent for peripartum toxicology testing and (2) the extent to which patient and hospital characteristics were associated with documented consent.
Retrospective cohort of individuals who underwent toxicology testing within 96 hours of delivery between April 2016 and April 2020 at five affiliated hospitals across Massachusetts. Medical records were reviewed for documentation of: clinician intent to obtain maternal toxicology, testing indication, verbal consent to testing, and child protective services involvement. Hierarchical multivariable logistic regression was used to examine the association between patient and hospital characteristics and documentation of verbal consent.
Among 60,718 deliveries, 1562 maternal toxicology tests were obtained. Verbal consent for testing was documented in 29.8% of cases (n=466). Documented consent was lacking across most demographic groups. Consent was no more likely to be documented when a report was filed with child protective services, and less likely in cases where the birthing parent lost custody prior to discharge (p=.003). In our multivariable model, consent was least likely to be documented when a maternal complication (abruption, hypertension, preterm labor, preterm premature rupture of membranes, intrauterine fetal demise) was the indication for testing (aOR, 0.46; CI, 0.28 to 0.76). Verbal consent was twice as likely to be documented in delivery hospitals with established consent policies (aOR, 2.10; CI, 1.01 to 4.37).
Consent for toxicology testing at delivery appears to be infrequently obtained based on clinician documentation. Provider education and hospital policies for obtaining informed consent are needed to protect the rights of birthing individuals.
More Needs to Be Done During the Informed Consent Process
Cureus Journal of Medical Science, 20 March 2022; 14(3)
Retinal detachment is an emergency commonly encountered in ophthalmic practice. In this article, a reflection about the ethical implications surrounding the informed consent process of retinal detachment repair is presented. We look at how premade informed consent forms allow for a better patient understanding of their condition, the procedure they are due to undergo, their postoperative course, and the potential complications they might face, hence potentially improving the overall outcome.