Deficiencies of Informed Consent Among Anesthesia Providers Named in Litigation: An Integrative Review

Miroslava Cova, RN, DNP, CRNA

DNP Nurse Anesthesia 

Deficiencies of Informed Consent Among Anesthesia Providers Named in Litigation: An Integrative Review

Project Category: Evidence Synthesis 

Project Team:  Miroslava Cova, DNP, CRNA Savannah Larsen, DNP, CRNA, Pamela Chambers, DNP, CRNA  (Advisor)

Abstract

Background: Anesthesia providers are legally and ethically obligated and expected to engage with patients to obtain informed consent before proceeding with the provision of anesthesia and invasive procedures. The process of informed consent has evolved significantly since the 1960’s, particularly regarding patient involvement in the decision-making process surrounding informed consent. Before 1960, the decision to treat was merely the physician’s choice, and there was no requirement to disclose any consequences to the patient. However, in 1960 the Supreme Court of Kansas ruled in Natanson v. Kline that physicians must disclose the consequences of treatment that a reasonable provider would disclose under the same or similar circumstances. This advocacy movement for appropriate patient disclosure was further strengthened in 1972, when the United States Courts of Appeals ruled in Canterbury v. Spence that physicians have a legal obligation to disclose what an average and reasonable person would consider material or necessary to their decision. This ruling led to establishment of what is known as the reasonable person standard (Hartgerink et al., 1998). Although the statutory standard for informed consent is determined by the state, the legal approach that guides determination of adequacy of the informed consent process is based on these reasonable standards. Furthermore, The Joint Commission at a minimum requires documentation of the informed consent process to include the discussion of the nature of the procedure; the risks and benefits of the procedure; reasonable alternatives; risks and benefits of alternatives; and assessment of the patient’s understanding of these elements (Shah et al., 2021).

Methods:  Due to the broad nature of the research problem, an integrative review methodology will be followed using the Framework for Knowledge Transfer (Lavis et al., 2003). This translation of evidence model was developed by Lavis et al. (2003) and provides an organizing framework to guide knowledge transfer in the form of five questions. This model is appropriate to adopt as it aligns with the stakeholders, the nature of inquisition, and the design of our DNP project. The four audiences this model considers suits the stakeholders that were identified to be impacted by this project. The general public, which includes the patients, families, and healthcare consumers, correlates with the recipients of the informed consent. The service providers or clinicians align with the anesthesia providers engaging in the informed consent process. Managerial decision-makers in hospitals correspond to hospital administrators or those in charge of overseeing the informed consent policies. Finally, the policy makers at federal, state, and local levels correlate with the informed consent writers at various government levels (Lavis et al., 2003). Additionally, these stakeholders may be considered by legal consultants and attorneys in the event of a legal dispute.

Results: Results will be organized according to emerging themes from the identified categories in the data extraction matrix, specifically the type of anesthesia delivered to the patient, trends according to anesthesia practice model and/or provider type, and missing elements of informed consent. Preliminary data extraction and evaluation of Eisenstadt v. Lalleman, 2022 and Shaffer v. Bragg, 2020 demonstrated that common themes and groups of data are starting to emerge. Both cases were related to neuraxial anesthesia and post dural puncture headache (PDPH) was the primary resulting injury. Defendants in both cases were not only the sole anesthesia providers, but also their associated facilities and/or entire anesthesia group. Primary responsible anesthesia provider in both cases was a physician anesthesiologist. While in Eisenstadt v. Lallemand, 2022 the entire informed consent process was omitted, in Shaffer v. Bragg, 2020 duty to disclose that a Student Registered Nurse Anesthetist (SRNA) would be working with the patient was the missing element of the informed consent.

Conclusion: The timeline for project completion is as follows: During HNAS 921 (November 14th, 2022 - February 17th, 2023), the legal database review, data collection, and data matrix extraction will be completed. Over the course of HNAS 922 (February 27th, 2023-May 19th, 2023) data extraction matrix will be completed along with a draft of manuscript for all sections except the full results and discussion.

Full Manuscript Slide Presentation Video