Utilization of a Parental Approach to Informed Consent in Intravenous Tissue Plasminogen Activator Administration Decision-Making: Patient Preference and Ethical Considerations
Research Article
Ann M. Murray, Ashley B. Petrone, Amelia K. Adcock
Neurology Research International, 5 September 2019
Abstract
Objective
While administration of intravenous tissue plasminogen activator (IV-tPA) is the standard of care in acute ischemic stroke and has been shown to have statistically significant benefit, there can also be potentially life-threatening complications; however, there is no standard informed consent approach. (e purpose of this study was to present a parental, technical, and general model of informed consent for IV-TPA and to determine which approach was preferred.
Methods
Survey respondents were asked to hypothetically decide whether or not to provide consent for their family member to receive IV-tPA. Respondents were presented with 3 informed consent models: one emphasizing parental qualities, one emphasizing statistical data, and one representing a general consent statement. After being presented each model, the respondents had to select their preferred consent model, as well as rate their level of agreeability toward their family member receiving the medication following each approach.
Results
(e results of 184 surveys showed respondents were equally as likely to give consent for their family member to receive IVTPA following all three approaches; however, respondents were significantly more likely to prefer the parental approach compared to a technical or general approach.
Conclusion
Our results indicate that while paternalism is generally discouraged in the medical community, some degree of parental language may be preferred by patients in tough decision-making situations toward consent to receive medical interventions.

Signature Informed Consent for Long-Term Opioid Therapy in Patients with Cancer: Perspectives of Patients and Providers
Original Article
Karleen Giannitrapani, Soraya Fereydooni, Azin Azarfar, Maria J. Silveira, Peter A. Glassman, Amanda Midboe, Amy Bohnert, Maria Zenoni, Robert D. Kerns, Robert A. Pearlman, Steven M. Asch, William Becker, Karl A. Lorenz
Journal of Pain and Symptom Management, 30 August 2019
Abstract
Context
Signature informed consent (SIC) is a part of a Veterans Health Administration (VHA) ethics initiative for patient education and shared decision-making with long-term opioid therapy (LTOT). Historically, patients with cancer-related pain receiving LTOT are exempt from this process.
Objectives
Our objective is to understand patients’ and providers’ perspectives on using signature informed consent for LTOT in patients with cancer-related pain.
Methods
Semi-structured interviews with 20 opioid prescribers and 20 patients who were prescribed opioids at two large academically-affiliated VHA Medical Centers. We employed a combination of deductive and inductive approaches in content analysis to produce emergent themes.
Results
Potential advantages of SIC are that it can clarify and help patients comprehend LTOT risks and benefits, provide clear upfront boundaries and expectations, and involve the patient in shared decision-making. Potential disadvantages of SIC include time delay to treatment, discouragement from recommended opioid use, and impaired trust in the patient-provider relationship. Providers and patients have misconceptions about the definition of SIC. Providers and patients question if SIC for LTOT is really informed consent. Providers and patients advocate for strategies to improve comprehension of SIC content. Providers had divergent perspectives on exemptions from SIC. Oncologists want SIC for LTOT to be tailored for patients with cancer.
Conclusion
Provider and patient interviews highlight various aspects about the advantages and disadvantages of requiring SIC for LTOT in cancer-related pain. Tailoring SIC for LTOT to be specific to cancer related concerns and to have an appropriate literacy level are important considerations.

Say what? Patients have poor immediate memory of major risks of interscalene block disclosed during the informed consent discussion
Original Article
Johnny Wei Bai, Faraj W W Abdallah, Melanie Cohn, Stephanie Ladowski, Poorna Madhusudan, Richard Brull
Regional Anesthesia & Pain Medicine, 23 August 2019
Abstract
Background 
Poor memory of disclosed risks can undermine informed consent and create medicolegal challenges. The extent to which patients remember the risks of peripheral nerve blockade following the informed consent discussion is unknown. This prospective cohort study evaluated patients’ immediate memory of risks related to interscalene block (ISB) that were disclosed during the preoperative informed consent discussion.
Methods 
Using a standardized script, patients scheduled for arthroscopic shoulder surgery were informed of the risks of ISB by an anesthesiologist in the preoperative assessment clinic. Immediately thereafter, consenting participants were asked to identify the risks of ISB from a printed list of nine true risks (four major and five minor) and nine ‘distractor’ items, which were unrelated adverse events and not disclosed. The primary outcome was the proportion of participants who remembered all four true major risks including long-term nerve damage, seizure, life-threatening event, and damage to the covering of the lung.
Results 
Among 125 participants, only 26 (21%) remembered all four major risks of ISB. The mean number of major risks remembered was 2±1 out of 4. Fifteen (12%) participants remembered all nine true risks. The mean number of true risks remembered was 6±2 out of 9. Multivariable analysis revealed that participants’ self-rated assessment of their memory was not associated with actual recall.
Conclusion 
Patients have poor immediate memory of the major risks related to ISB disclosed during the informed consent discussion. Under the present study conditions, the validity of the informed consent process for patients undergoing ISB may be undermined.

Obtaining consent for obstetric procedures
KatrinaHenderson, SiânGriffiths
Anaesthesia & Intensive Care Medicine, 19 August 2019
Abstract
Consent is a process that involves information disclosure of a proposed treatment or intervention. It includes a discussion of the risks relevant to that particular patient as well as the benefits and alternative options. The process must be clearly documented to provide a legal justification for treatment. Obtaining informed consent can be a challenge when a labouring woman is in severe pain or under the influence of strong analgesics. High-risk women should be encouraged to attend pre-assessment clinics to enable adequate time to process the information discussed. Pregnant women are presumed competent and are entitled to refuse treatment even if this risks their life or the life of their fetus. Rarely, if a woman is not considered competent to make decisions for herself, clinicians should take into account the underlying reasons and consider proceeding in their best interests under the doctrine of necessity or apply to the courts for approval of an intervention. This article summarizes current guidelines in relation to consent that have been updated to reflect recent case law.

Deferred consent for delivery room studies: the providers’ perspective
Original Article
Maria C den Boer, Mirjam Houtlosser, Elizabeth E Foglia, Enrico Lopriore, Martine Charlotte de Vries, Dirk P Engberts, Arjan B te Pas
Archives of Disease in Childhood: Fetal & Neonatal, 19 August 2019
Abstract
Objective 
To gain insight into neonatal care providers’ perceptions of deferred consent for delivery room (DR) studies in actual scenarios.
Methods 
We conducted semistructured interviews with 46 neonatal intensive care unit (NICU) staff members of the Leiden University Medical Center (the Netherlands) and the Hospital of the University of Pennsylvania (USA). At the time interviews were conducted, both NICUs conducted the same DR studies, but differed in their consent approaches. Interviews were audio-recorded, transcribed and analysed using the qualitative data analysis software Atlas.ti V.7.0.
Results                                                       
Although providers reported to regard the prospective consent approach as the most preferable consent approach, they acknowledged that a deferred consent approach is needed for high-quality DR management. However, providers reported concerns about parental autonomy, approaching parents for consent and ethical review of study protocols that include a deferred consent approach. Providers furthermore differed in perceived appropriateness of a deferred consent approach for the studies that were being conducted at their NICUs. Providers with first-hand experience with deferred consent reported positive experiences that they attributed to appropriate communication and timing of approaching parents for consent.
Conclusion 
Insight into providers’ perceptions of deferred consent for DR studies in actual scenarios suggests that a deferred consent approach is considered acceptable, but that actual usage of the approach for DR studies can be improved on.

Attitudes, Beliefs, and Practices of Aesthetic Plastic Surgeons Regarding Informed Consent
Accepted Manuscript
Chelsea O Hagopian, Teresa B Ades, Thomas M Hagopian, Erik M Wolfswinkel, W Grant Stevens
Aesthetic Surgery Journal, 30 July 2019
Abstract
Background
Best practice for informed consent in aesthetic plastic surgery is a process of shared decision-making (SDM), yet evidence strongly suggests this is not commonly reflected in practice nor is it supported by traditional informed consent documents (ICD). Falsely held beliefs by clinicians about SDM may contribute to its lack of adoption.
Objective
To understand the baseline attitudes, beliefs, and practices of informed consent among board-certified plastic surgeons with a primarily aesthetics practice.
Methods
A 15-question online survey was emailed to active members of the American Society for Aesthetic Plastic Society (ASAPS). Items included: demographics, Likert scales, free-text, acceptability, and one question seeking consensus on general information all patients must understand before any surgery.
Results
This survey appreciated a 13% response rate with a 52% completion rate across 10 countries and 31 U.S. states. 69% are very-extremely confident that ICD contain evidence-based information. 63% are not at all-not so confident in ICD effectiveness of prompting patients to teach-back essential information. 51% believe surgical ICD should be reviewed annually. 86% report assistance with patient education during informed consent. “ASAPS members” should be a source of evidence for content (free-text). 63% were somewhat-very satisfied with the survey and 84% will probably-definitely yes participate in future surveys.
Conclusions
Findings echo concerns in the literature that ICD are focused on disclosure not patient understanding. There is notable concern regarding information overload and retention, but less regarding the quality and completeness of information. Current culture suggests key clinician stakeholders are amenable to change.

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.