Association of Preoperative Disclosure of Resident Roles With Informed Consent for Cataract Surgery in a Teaching Program
Original Investigation
Alicia M. Corwin, Jonathan N. Rajkumar, Bruce J. Markovitz, Avrey Thau, Douglas M. Wisner, John M. Spandorfer, Benjamin E. Leiby, Robert Bailey, George L. Spaeth, Alex V. Levin
JAMA Ophthalmology, 25 July 2019
Abstract
Importance  
Cataract surgery is the most commonly performed intraocular surgery. Academic centers have mandates to train the next surgeon generation, but resident roles are often hidden in the consent process.
Objective  
To investigate associations of full preoperative disclosure of the resident role with patient consent rates and subjective experience of the consent process.
Design, Setting, and Participants  
Full scripted disclosure of residents’ roles in cataract surgery was delivered by the attending surgeon. Qualitative analysis was conducted from recorded interviews of patients postoperatively regarding consent process experience and choice of whether to allow resident participation. Associations were sought regarding demographic characteristics and consent rates. Patients were recruited though a private community office. Surgery was performed at a single hospital where resident training was routinely conducted. The study included systemically well patients older than 18 years with surgical cataract. They had no previous eye surgery, English fluency, and ability to engage in informed consent decision-making and postsurgery interview. Patients were ineligible if they had monocular cataracts, required additional simultaneous procedures, had history of ocular trauma, or had cataracts that were surgically technically challenging beyond the usual resident skill level.
Interventions  
Eligible patients received an informed consent conversation by the attending physician in accordance with a script describing projected resident involvement in their cataract surgery. Postoperatively, patients were interviewed and responses were analyzed with a quantitative and thematic qualitative approach.
Main Outcomes and Measures  
Consent rates to resident participation and qualitative experience of full disclosure process.
Results  
Ninety-six patients participated. Participants were between ages 50 and 88 years, 53 were men (55.2%), and 75 were white (85.2%). A total of 54 of 96 participants (56.3%; 95% CI, 45.7%-66.4%) agreed to resident involvement. There were no associations between baseline characteristics and consent to resident involvement identified with any confidence, including race/ethnicity (60% [45 of 75] in white patients vs 30.8% [4 of 13] in nonwhite patients; difference, 29.2%; 95% CI, −0.7% to 57.3%; Fisher exact P = .07). Thematically, those who agreed to resident involvement listed trust in the attending surgeon, contributing to education, and supervision as contributing factors. Patients who declined stated fear and perceived risk as reasons.
Conclusions and Relevance  
Our results suggest 45.7% to 66.4% of community private practice patients would consent to resident surgery. Consent rates were not associated with demographic factors. Because residents are less often offered the opportunity to do surgery on private practice patients vs academic center patients, this may represent a resource for resident education.

Training surgeons and the informed consent discussion in paediatric patients: a qualitative study examining trainee participation disclosure
Original Article
Kunal Bhanot, Justin Chang, Samuel Grant, Annie Fecteau, Mark Camp
BMJ, 19 July 2019
Open Access
Abstract
Background 
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.
Methods 
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.
Results 
Five main themes were identified from the interviews. (1) Surgeons do not consistently disclose the role of surgical trainees to parents. (2) Surgical trainees are purposefully vague in disclosing their role during the consent discussion without being misleading. (3) Surgeons and surgical trainees believe parents do not fully understand the specific role of surgical trainees. (4) Graduated responsibility is an important aspect of training surgeons. (5) Surgeons feel a responsibility towards both their patients and their trainees. Surgeons do not explicitly inform patients about trainees, believing there is a lack of understanding of the training process. Trainees believe families likely underestimate their role and keep information purposely vague to reduce anxiety.
Conclusion 
The majority of surgeons and surgical trainees do not voluntarily disclose the degree of trainee participation in surgery during the informed consent discussion with parents. An open and honest discussion should occur, allowing for parents to make an informed decision regarding their child’s care. Further patient education regarding trainees’ roles would help develop a more thorough and patient-centred informed consent process.

Ethical challenges of obtaining informed consent from surgical patients
Research Article 
Sanaz Moeini, Mohsen Shahriari, Mahdi Shamali
Nursing Ethics, 11 July 2019 
Abstract
Background
Informed consent can be obtained by various methods, by various people, and with use of various types of consent forms. Persistent effort is necessary to reveal the practical realities of informed consent to improve ethical and legal standards.
Objective
To determine the ethical challenges of obtaining informed consent from surgical patients.
Methods
The present study was a descriptive cross-sectional study using two researcher-made questionnaires and a checklist for data collection. Data were collected from nursing personnel (n = 95) and surgical patients (n = 203) on the surgical wards of three university hospitals in Isfahan, Iran. Data were analyzed using descriptive statistics, Spearman’s rank correlation, Pearson’s correlation coefficient, and the t-test.
Ethical considerations
The study was approved by the Ethics Committee of Isfahan University of Medical Sciences (No: 396478).
Results
The mean scores (maximum 100) of awareness, competency, and authority were 36.3, 67.7, and 57.6, respectively. The overall quality of the informed consent was poor (score 53.9 of 100). The higher educational level in patients was correlated with lower awareness of and less authority to give informed consent. Only 12.6% of the nurses stated that patients were given sufficient information to assure informed consent. In 89.2% of the consent forms, the risks of the treatment were mentioned. However, alternative methods and risks and advantages of rejecting the treatment were not mentioned in any of the forms.
Conclusion                              
Ethical challenges to obtaining informed consent include patients’ poor awareness of their rights, a failure to provide adequate information to patients, absence of consideration of patients’ educational level, an unclear definition of who is responsible for obtaining informed consent from the patients, time constraints, and use of unclear language and medical jargon. Constructing an ethical framework may guide nursing staff in dealing with the ethical challenges involved in obtaining informed consent.

Implementation of a Bundled Consent Process in the ICU; A Single-Center Experience
Asha M. Anandaiah, Jennifer P. Stevens, Amy M. Sullivan
Critical Care Medicine, 11 July 2019
Abstract
Objectives 
A bundled consent process, where patients or surrogates provide consent for all commonly performed procedures on a single form at the time of ICU admission, has been advocated as a method for improving both rates of documented consent and patient/family satisfaction, but there has been little published literature about the use of bundled consent. We sought to determine how residents in an academic medical center with a required bundled consent process actually obtain consent and how they perceive the overall value, efficacy, and effects on families of this approach.
Design
Single-center survey study.
Setting
Medical ICUs in an urban academic medical center.
Subjects 
Internal medicine residents.
Interventions
We administered an online survey about bundled consent use to all residents. Quantitative and qualitative data were analyzed.
Measurements and Main Results
One-hundred two of 164 internal medicine residents (62%) completed the survey. A majority of residents (55%) reported grouping procedures and discussing general risks and benefits; 11% reported conducting a complete informed consent discussion for each procedure. Respondents were divided in their perception of the value of bundled consent, but most (78%) felt it scared or stressed families. A minority (26%) felt confident that they obtained valid informed consent for critical care procedures with the use of bundled consent. An additional theme that emerged from qualitative data was concern regarding the validity of anticipatory consent.
Conclusions
Resident physicians experienced with the use of bundled consent in the ICU held variable perceptions of its value but raised concerns about the effect on families and the validity of consent obtained with this strategy. Further studies are necessary to further explore what constitutes best practice for informed consent in critical care.

Valid consent and orthodontic treatment
Maurice J Meade, Annalene Weston, Craig W Dreyer
Australasian Orthodontic Journal, May 2019; 35(1) 
Abstract
Valid patient consent is a legal and ethical principle that is fundamental to healthcare provision. Oral health practitioners (OHPs) must understand the principles that need to be addressed to ensure that the consent given by a patient is valid. Failure to obtain consent may result in a negligence claim or a complaint of professional misconduct against the OHP. Orthodontic treatment is mostly elective but is not without risk to the patient. Obtaining and maintaining valid consent for orthodontic treatment presents additional challenges in comparison with other dental procedures as the treatment lasts over a longer time and is most commonly performed in adolescents. In addition, prospective patients need to be informed regarding ‘lifelong’ management in the retention phase to minimise the risk of relapse. The present paper outlines the principles of valid consent with particular regard to orthodontic treatment in the adolescent patient. OHPs must ensure that they are satisfied that the competent patient has the capacity to voluntarily consent. Clinicians must also recognise that valid consent is not a one-off ‘tick the box’ procedural exercise but an ongoing process of effective information sharing in light of changing laws and an ever-changing scientific evidence base within a patient-centred model of healthcare.

Perceptions and Perspectives of Patients regarding process of informed consent in a tertiary care hospital
Original Article
Shanaz Kouser, Tahira Fatima, Zunaira Tabassum, Khushbakht Anwar
Pakistan Journal of Medical and Health Sciences, January – March 2019
Open Access
Abstract
Aim
To analyze the patient’s perceptions and perceptive about different components and procedure of taking informed consent in a tertiary care hospital
Methods
This was a cross sectional study conducted with a predesigned interview based questionnaire form. 150 patients who underwent cesarean section, were randomly selected for study at Jinnah Hospital, Lahore, which is a tertiary care multidisciplinary hospital. Patients who had some emergency surgical procedures, patients who belonged to a medical profession and the patients who refused to be interviewed were excluded from the study. Data was analyzed in SPSS Ver:17.0. Frequencies and percentages were calculated for demographic and perception process regarding informed consent.
Results
A total of 150 patients were included in the study. Age range of the patients, who were interviewed was 18-44 years. Majority of the patients were primipara 89(59.3%).Out of all cases, 64(42.7%) of patients were from rural areas and 88 patients (58.7%) belonged to poor socioeconomic class. Almost half of the patients 77(57.3%) were uneducated. It was observed that husbands, parents in law and patient’s own parents were somehow or other were involved in the decision making process. In 107 cases (71.3%), the consent form was signed by the husband. The other forms were signed by mother in law 12( 8%) and by patient’s own parents 31(20.7%), surprisingly none of the patients signed her own consent form as primary consenting person though they were told about the reasons for cesarean section (n=134, 89.3%) by the signatory.
Conclusion
Majority of the patients in our set-up were satisfied with the process of informed consent, though at times, some of them were not fully aware about indications, risks and benefits of the surgery.