Professionals’ Practices and Views regarding Neonatal Postmortem: Can We Improve Consent Rates by Improving Training?

Professionals’ Practices and Views regarding Neonatal Postmortem: Can We Improve Consent Rates by Improving Training?
Spierson H.a, Kamupira S.a, Storey C.b, Heazell A.E.P.
Neonatology, 2019; 115 pp 341–345
In the UK, rates of neonatal postmortem (PM) are low. Consent for PM is required, and all parents should have the opportunity to discuss whether to have a post-mortem examination of their baby.
We aimed to explore neonatal healthcare professionals’ experiences, knowledge, and views regarding the consent process for post-mortem examination after neonatal death.
An online survey of neonatal healthcare providers in the UK was conducted. Responses from 103 healthcare professionals were analysed, 84 of whom were doctors. The response rate of the British Association of Perinatal Medicine (BAPM) members was 11.7%.
Perceived barriers to PM included cultural and religious practices of parents as well as a lack of rapport between parents and professionals. Of the respondents, 69.4% had observed a PM; these professionals had improved satisfaction with their training and confidence in counselling (p < 0.001 and p < 0.001) but not knowledge of the procedure (p = 0.77). Healthcare professionals reported conservative estimates of the likelihood that a PM would identify significant information regarding the cause of death.
Confidence of neonatal staff in counselling could be improved by observing a PM. Training for staff in developing a rapport with parents and addressing emotional distress may also overcome significant barriers to consent for PM.

Anticipatory Waivers of Consent for Pediatric Biobanking

Anticipatory Waivers of Consent for Pediatric Biobanking
Jane A. Hartsock, Peter H. Schwartz, Amy C. Waltz, Mary A. Ott
Ethics & Human Research, 20 March 2019; 41(2) pp 14-21
As pediatric biobank research grows, additional guidance will be needed about whether researchers should always obtain consent from participants when they reach the legal age of majority. Biobanks struggle with a range of practical and ethical issues related to this question. We propose a framework for the use of anticipatory waivers of consent that is empirically rooted in research that shows that children and adolescents are often developmentally capable of meaningful deliberation about the risks and benefits of participation in research. Accordingly, bright‐line legal concepts of majority or competency do not accurately capture the emerging capacity for autonomous decision‐making of many pediatric research participants and unnecessarily complicate the issues about contacting participants at the age of majority to obtain consent for the continued or first use of their biospecimens that were obtained during childhood. We believe the proposed framework provides an ethically sound balance between the concern for potential exploitation of vulnerable populations, the impetus for the federal regulations governing research with children, and the need to conduct valuable research in the age of genomic medicine.

The biobank consent debate: why ‘meta-consent’ is still the solution!

The biobank consent debate: why ‘meta-consent’ is still the solution!
Thomas Ploug, Soren Holm
Journal of Medical Ethics, 14 March 2019
In a recent article in the Journal of Medical Ethics, Neil Manson sets out to show that the meta-consent model of informed consent is not the solution to perennial debate on the ethics of biobank participation. In this response, we shall argue that (i) Manson’s considerations on the costs of a meta-consent model are incomplete and therefore misleading; (ii) his view that a model of broad consent passes a threshold of moral acceptability rests on an analogy that misconstrues how biobank research is actually conducted and (iii) a model of meta-consent is more in tune with the nature of biobank research and enables autonomous choice.

Consent in the Exam Room

Consent in the Exam Room
Jennifer Mendillo Keller
The Journal of Sexual Medicine, 26 March 2019
Explicitly obtaining consent from a patient prior to starting a sensitive physical exam is essential to improve their experience with intimate examinations such as the genitourinary exam.
The purpose of this article is to raise awareness among providers about how and why to obtain consent for intimate examinations.
The current literature on consent was reviewed and the opinion piece was created using current events and literature.
Outcome measures
Providers have a responsibility to consent patients for a sensitive exam.
Explicitly obtaining consent from a patient prior to starting a sensitive physical exam such as a genitourinary exam is essential to improve the patient experience with such exams.

Perioperative Complications Chapter: Shared Decision-Making and Informed Consent

Perioperative Complications Chapter: Shared Decision-Making and Informed Consent
William K. Hart, Robert C. Macauley, Daniel A. Hansen, Mitchell H. Tsai
Catastrophic Perioperative Complications and Management, 20 March 2019; pp 397-406
The practice of anesthesiology has grown remarkably safer, but complications ranging from minor to catastrophic may still occur. Improvements in patient safety have made surgery and anesthesia both commonplace and routine. The perioperative process, which classically began with admission to the hospital the night before the day of surgery, has been condensed into the efficient and increasingly cost-effective process of outpatient surgery. Patient confidence and comfort with this process has much to do with openness and communication on behalf of anesthesiologists and surgeons which did not always exist.

Informed consent acknowledges the patient’s individual autonomy and right to decide what medical or surgical interventions should be a part of his or her health care. A patient may elect to pursue a certain treatment when he or she is determined to have decision-making capacity; risks, benefits, and alternatives to the proposed treatment have been adequately disclosed; and the decision to pursue treatment is voluntary, or free of external coercion.

Shared decision-making builds on the foundation of informed consent. It broadens the discussion to include the patient’s goals of care, beliefs, and expectations in context with the physician’s expert recommendation and experience. While perhaps most essential in high-risk operations and medically complex patients, shared decision-making is becoming increasingly recognized as a valuable tool for all patients in the perioperative process. Benefits of shared decision-making include increased patient satisfaction, cost savings, and decreased litigation.

Many institutions across the country have implemented multidisciplinary care teams to evaluate complex patients preoperatively, guide the decision-making process, plan for both postoperative care and unanticipated outcomes, and establish advanced directives. Informed consent and shared decision-making coupled with evidence-based medicine are an increasingly essential aspect of the patient-centered perioperative process.

Informed consent practice for obstetric and gynaecologic procedures: A patients’ perspective from a developing country

Informed consent practice for obstetric and gynaecologic procedures: A patients’ perspective from a developing country
Zeeshan MF, Yousufi Z, Khan D, Malik FR, Ashfaq F, Batool F, Atta L, Tariq H, Huma Z, Ghafoor R, Jamil A, Qazi U
Journal of Evaluation in Clinical Practice, 28 February 2019
To assess the surgical informed consent (SIC) practices for obstetric and gynaecological (OB-GYN) procedures at different hospitals in Pakistan.
Study was conducted in five hospitals (three public and two private) of Peshawar, Pakistan. A pretested structured tablet-based questionnaire was administered from October 2016 through January 2017 among post-op OB-GYN patients.
About 27% of the patients (significantly more in private hospitals, P = 0.001) did not remember a formal consent administration. Most patients (80%) felt they had no choice about signing the consent. About 65% (mostly in public as compared with private hospitals) mentioned that they would have signed it regardless of the specifics in it (P < 0.001). Patients had increased odds to recall consent if they felt empowered, odds ratio (OR) = 4.5; had an opportunity to ask questions, OR = 7.2; wanted more explanation, OR = 2.8; and had consent administered in their mother tongue, OR = 6.9.
Patients’ recall of key elements of consent was low. The time spent with the patient for consenting was much shorter than recommended. The printed consent forms were mostly not available in patients’ mother tongue.
Consent practice for OB-GYN procedures was suboptimal in studied hospitals. Patients’ attitude toward informed consent practices largely reflected providers’ focus on obtaining a legally valid signed consent as opposed to administering a consent that empowers patients to make an informed decision in the absence of any external pressure.

Improving the Effectiveness of the Informed Consent Process in Elective Aesthetic Procedures [POSTER]

Improving the Effectiveness of the Informed Consent Process in Elective Aesthetic Procedures [POSTER]
Hagopian, Chelsea Olivia; Ades, Teresa B.; Hagopian, Thomas Martin; Wolfswinkel, Erik; Stevens, Grant
Virginia Henderson Global Nursing e-Repository, 14 February 2019
Informed consent is commonly reduced to a legal formality rather than upholding its ethical ideal of being a process of shared decision-making. We present a multiphase development process model for creating a patient decision aid prototype to replace the traditional informed consent documents for primary breast augmentation surgery.

Informed-Consent Taking Procedure for Elective Surgery in Gaza strip: Patient’s Satisfaction with Doctor’s Communication

Informed-Consent Taking Procedure for Elective Surgery in Gaza strip: Patient’s Satisfaction with Doctor’s Communication
Khamis Elessi, Mohammed Elifranji, Zuhdi Elifranji
Islamic University Gaza Journal of Natural Studies, 12 March 2017; 26(1) pp 18-29
Widespread dissatisfaction and mistrust exists among patients in the Gaza Strip towards doctors. A sense of a lack of sufficient information regarding diagnosis, risks and benefits of interventions and subsequent management plans is present among patients. All of these areas are considered essential components in the surgical consent process. A gap between patients’ actual understanding and that perceived by doctors has been shown to exist in different settings.1 Unfortunately, no former study has been done on this topic in the GazaStrip.
This study aims to assess the satisfaction of patients in Gaza with the information provided to them during the consent process prior to an invasive procedure and compare this to the current practice and attitudes of surgeons.
A five-section self-designed questionnaire was administered using convenience sampling to the first 60 patients and first 60 surgeons who met the selection criteria in the two hospitals in the Gaza Strip: Al-Shifa Hospital and the European Gaza Hospital.
Among the surgeons surveyed, 55% answered that informed consent should be obtained by doctors only, 3% thought that it can be obtained by nurses only, while 45% stipulated either doctors or nurses can obtain it. In total only 38% of those healthcare professionals taking the consent from the patient, actually performed the procedure. During consent procedures, 73% of surgeons reported providing written documents 30% drawings explaining the procedure, 3% giving videos or animations and 8% suggesting website links for more information. The survey of patients revealed that only 25% of surveyed surgeons identified themselves to their patients, and 12% asked for the patients’ signature without a complete discussion of the intervention. Around 35% of surgeons depended on verbal communication only. Surgeons identified barriers for best practice as time constraints, as well as lack of hospital policies and informational resources. However, 87% of surgeons believed that informed consent has an impact on patient wellbeing. A total of 90% of surveyed patients thought they received the right treatment and were satisfied. While 43% of patients prefer to travel overseas to get treatment, 77% of these because of a perceived lack of medical equipment and facilities.

Consent Recommender System: A Case Study on LinkedIn Settings

Consent Recommender System: A Case Study on LinkedIn Settings
Rosni K V, Manish Shukla, Vijayanand Banahatti, Sachin Lodha
Central Europe Workshop Proceedings, 18 March 2019; 2335 pp 53-60
Privacy is an increasing concern in the digital world, especially when it has become a common knowledge that even high profile enterprises process data without data-subject’s consent. In certain cases where data-subject’s consent was taken, it was not linked to the proper purpose of processing. To address this growing concern, newer privacy regulations and laws are emerging to empower a data-subject with informed and explicit consent through which she can allow or revoke usage of her personal data. However, it has been shown that privacy self-management does not provide the expected results. This is mainly due to information overload as data-subjects use multiple services entailing variety of purposes, and hence, resulting in a very large number of consent requests. This may lead to consent fatigue as data-subject is now expected to provide informed consent for each associated purpose. The consent fatigue in data-subjects can lead to either incorrect decision making or opting for default values provided by the enterprise, and thus, defeating the purpose of new data privacy regulations. In this work, we discuss the factors influencing the informed consent of a data-subject. Further, we propose a ‘consent recommender system’ based on Factorization Machines (FMs) to assist the data-subject and thereby avoiding consent fatigue. Our consent recommender system effectively models the interaction between the different factors which influence a data-subject’s informed consent. We discuss how this setup extends for cold start data-subjects facing the decision problem with consent requests from multiple enterprises. Additionally, we demonstrate the scenario of consent recommendation as a prediction problem with minimum attributes available from LinkedIn’s privacy settings.

Informed consent (IC), randomized controlled trial digital vs conventional IC

Informed consent (IC), randomized controlled trial digital vs conventional IC
Galve La Hoz, J. Rioja, E. Salas, L. Enguita, M. Sanz Del Pozo, D. Corbatón, C. Gareta, S. Ezquerro, M. Muñoz, T. Cabañuz, P. Gil, M.J. Gil
European Urology Supplements, March 2019; 18(1) pp e847
Introduction& Objectives
In order to satisfy the informed consent process, patients must understand the information they receive. We know have support tools, like hyperrealistic simulations, which improve the understanding of informed consent. The objective of the study is to demonstrate that digital informed consent, with hyperrealistic simulations, improved the understanding of information and, therefore, informed consent.
Materials& Methods
The study included 84 participants who underwent a transurethral resection of the bladder, transurethral resection of the prostate or ureterostomy in our department. Participants were randomly assigned to either intervention or control group using the closed envelopes method. Informed consent was obtained in the outpatient clinic and patients were included in the study at hospital admission, when they were informed again. Intervention group watched a hyper realistic simulation from IURO app, consecutive, and completed a validated questionnaire. The control group completed the questionnaire without watching any simulation. The primary outcomes was subjective information perception. We used Mann-Whitney U test for statistical analysis.
42 participants were assigned to each group. 4 participants in the intervention group did not complete the questionnaire versus 5 in the control group. Th intervention group, called digital consent, showed a higher subjective information perception than the control group, called the conventional group (figure 1 p= 0,001). The anxiety level in both groups was similar. In the subgroup analysis we observed that participants who had a basic level in the study or educational showed a higher subjective information perception in th digital group than the conventional group (p=0.006). We did not observe these differences in the subgroup with a higher level of study or educational.