Improving Consent Documentation in the Medical Intensive Care Unit
Original Article
Armin Krvavac, Pujan H. Patel, Ghassan Kamel, Zeyu Hu, Nirav Patel
Curesus, 17 November 2019; 11(11)
Open Access
Abstract
The contemporary patient-centered medical practice relies upon the acquisition of informed consent, which serves as written proof that the patient has recognized and agreed to the risks and benefits of their treatment. Well-documented informed consent forms are not only reflective of important ethical practices in medicine but can also serve as legal documents to protect healthcare providers from undue liabilities. We conducted a quality improvement project with the intention to improve the accuracy and completeness of consent form documentation in the medical intensive care unit.

The evaluation of consent forms before our intervention revealed that only 6.8% were correctly completed, with an average of 10.2 out of 14 (73%) essential items correct. Our intervention involved a multifaceted approach that included targeted education in combination with process improvement. The post-intervention results at one month revealed improvement in consent form accuracy from 6.8% to 60% (p = 0.0001), with an increase in the average number of essential items documented correctly from 10.2 to 13.5 (p = 0.0001). Data were collected three months post-intervention to evaluate for sustained improvement. Results revealed a significant decrease in consent form accuracy to 39% when compared to the one-month post-intervention data but still maintained a statistically significant improvement when compared to initial baseline data; 6.8% to 39% (p = <0.01).

Following the intervention, overall consent form accuracy improved significantly at our institution. Furthermore, these positive adjustments persisted when assessed at three months post-intervention despite the decrease as compared to one-month post-intervention. This trend suggests that our multifaceted intervention was able to increase the quality and accuracy of consent form documentation successfully.

Informed consent in obstetrics: a survey of pregnant women to set a new standard in informed consent for emergency obstetric interventions [POSTER]
Tracey Sturgeon, Huma Ayaz, Kirsty McCrorie, Kate Stewart
BMJ Leader, 3 November 2019; 3(A9)
Open Access
Abstract
Respect for autonomy supports the rights of women to make their own decisions about care as laid out by the Supreme Court ruling on Montgomery (2015). Consent for emergency procedures in obstetrics presents a significant challenge. Consent obtained when a woman is exhausted, influenced by endogenous or exogenous chemicals or in fear of her unborn child’s safety cannot be considered to be informed. An opportunistic survey of pregnant women in Highland region was conducted over 6 weeks in community and secondary care antenatal clinics. Primary objective-determine women’s current understanding of emergency obstetric interventions in labour to guide our work in achieving informed consent. Secondary objective-compare regional and Scottish national delivery data to allow realistic counseling of women regarding possibility of such interventions. Results were analysed and comments qualitatively explored. Labour and delivery expectations of survey participants were compared to regional and Scottish national delivery data (2018). We found that many women were uncertain regarding possibility of intervention. Both prim and parous women requested more information; some specifically asked for up-to-date statistics. Regional and Scottish national delivery intervention rates were comparable. Current intervention rates (by regional and Scottish national data) are significantly higher than expected. Our data is in keeping with Scottish data so this is likely an issue in other regions too. Our survey showed pregnant women may not have realistic expectations of delivery outcomes. Pregnant women need information based on regional and national data to foster realistic expectations of labour or delivery; empowering decision-making and ensuring peri-partum emergency consent is still informed consent. A multi-disciplinary approach to a novel means of obtaining informed consent will allow NHS Highland to lead the way in implementing change to improve the care of our pregnant women.

Interventions to Improve Informed Consent: Perhaps Surgeons Should Speak Less and Listen More
Invited Commentary
Peter Angelos
JAMA Surgery, 30 October 2019
Exceprt
High-quality informed consent is central to the ethical practice of surgery. In this issue of JAMA Surgery, Schwarze and colleagues report on a novel attempt to increase patient engagement and well-being by sending older surgical patients a question prompt list (QPL) before their visit with a surgeon. For older patients undergoing high-risk operations, the authors have appropriately pointed out that the surgical procedure is often the start of a lengthy hospitalization and subsequent substantial changes in their ability to live independently or return to preoperative health status. They sought to improve the informed consent process for this group of vulnerable patients by working with surgeons to develop an informational brochure with a list of 11 questions to prompt patients and family members to ask their surgeons about treatment options, expectations for recovery, and management of potential serious complications…

Infringement of the right to surgical informed consent: negligent disclosure and its impact on patient trust in surgeons at public general hospitals – the voice of the patient
Research Article
Gillie Gabay, Yaarit Bokek-Cohen
BMC Medical Ethics, 28 October 2019; 20(77)
Open Access
Abstract
Background
There is little dispute that the ideal moral standard for surgical informed consent calls for surgeons to carry out a disclosure dialogue with patients before they sign the informed consent form. This narrative study is the first to link patient experiences regarding the disclosure dialogue with patient-surgeon trust, central to effective recuperation and higher adherence.
Methods
Informants were 12 Israelis (6 men and 6 women), aged 29–81, who underwent life-saving surgeries. A snowball sampling was used to locate participants in their initial recovery process upon discharge.
Results
Our empirical evidence indicates an infringement of patients’ right to receive an adequate disclosure dialogue that respects their autonomy. More than half of the participants signed the informed consent form with no disclosure dialogue, and thus felt anxious, deceived and lost their trust in surgeons. Surgeons nullified the meaning of informed consent rather than promoted participants’ moral agency and dignity.
Discussion
Similarity among jarring experiences of participants led us to contend that the conduct of nullifying surgical informed consent does not stem solely from constraints of time and resources, but may reflect an underlying paradox preserving this conduct and leading to objectification of patients and persisting in paternalism. We propose a multi-phase data-driven model for informed consent that attends to patients needs and facilitates patient trust in surgeons.
Conclusions
Patient experiences attest to the infringement of a patient’s right to respect for autonomy. In order to meet the prima facie right of respect for autonomy, moral agency and dignity, physicians ought to respect patient’s needs. It is now time to renew efforts to avoid negligent disclosure and implement a patient-centered model of informed consent.

Informed consent for whole blood donation
Brian Grainger, Peter Flanagan
Vox Sanguinis, 21 October 2019
Open Access
Abstract
Background and objectives
It is recognized that blood transfusion services have an ethical duty to obtain informed consent from their voluntary, non-remunerated donors. This right was most recently affirmed by the 2017 revision of the International Society of Blood Transfusion (ISBT) Code of Ethics. However, the constituent elements necessary to adequately inform such consent have not been definitively established.
Materials and methods
This review evaluates the historical background to informed consent in medicine and as it has been applied to blood donation. The question of what information should be disclosed is then considered with regard to existing statutory requirements in both the United States and EU as well guidance from relevant international organizations. The emerging ethical issues around repurposing of donated blood for sale as recovered plasma and use in research are included in this analysis.
Results
A reasonable basis is found in the literature to advocate that valid informed consent of blood donors should encompass: the donation process itself and potential adverse effects, the need for pre-donation transfusion-transmissible infection (TTI) screening, potential non-transfusion uses of derived products, requirements to obtain and store personal information, the consequences that non-disclosure of such information may have for both the donor and the recipient and reassurance as to the confidentiality of this information.
Conclusion
Informed consent is a key component of the duty of care between a blood service and its donor. We identify essential elements that should be present for such consent to be considered valid.

Editor’s note: Vox Sanguinis is an International Society of Blood Transfusion publication.

Cardiologists’ and patients’ views about the informed consent process and their understanding of the anticipated treatment benefits of coronary angioplasty
Survey Study
Felicity Astin, John Stephenson, Joy Probyn, Janet Holt, Keith Marshall, Dwayne Conway
European Journal of Cardiovascular Nursing, 9 September 2019
Abstract
Background: Percutaneous Coronary Intervention (PCI) is a common revascularisation technique. Serious complications are uncommon, but death is one of them. Seeking informed consent in advance of PCI is mandatory. Research shows that PCI patients have inaccurate perceptions of risks, benefits, and alternative treatments. Aim: To assess cardiologists’ and patients’ views about the informed consent process and anticipated treatment benefits. Methods: Two cross-sectional, anonymous surveys were distributed in England. An electronic version to a sample of cardiologists, and a paper based version to patients recruited from 10 centres. Results: A sample of 118 cardiologists and 326 patients completed the surveys. Cardiologists and patients shared similar views on the purpose of informed consent; however, over 40% of patients and over a third of cardiologists agreed with statements that patients do not understand, or remember, the information given to them. Patients placed less value than cardiologists upon the consent process and over 60% agreed that patients depended on their doctor to make the decision for them. Patients’ and cardiologists views on the benefits of PCI were significantly different; notably, 60% of patients mistakenly believed PCI was curative. Conclusions: The PCI informed consent process requires improvement to ensure that patients are more involved and accurately understand treatment benefits to make an informed decision. Redesign of the patient pathway is recommended to allow protected time for health professionals to engage in discussions using evidence based approaches such as ‘teach back’ and decision support which improve patient comprehension.