Do Patients with Acute Medical Conditions Have the Capacity to Give Informed Consent for Emergency Medicine Research?

Abstract

Abstract. Objective: Because of stress and illness, conscious emergency medicine (EM) patients may be temporarily cognitively impaired and thus incapable of participating in the informed consent process for acute care research. This pilot study sought to assess the mental capacity of ED patients during their evaluation and treatment for acute myocardial infarction (AMI). Methods: A prospective observational design at a university tertiary referral center. EM patients with AMI from November 1996 to February 1997 were enrolled. While usual care was delivered, patients were administered three subtests of the Wechsler Adult Intelligence Scale-Revised (WAIS-R) test. Subtest scaled scores range from 1 to 19, with abnormal being less than 5. Demographic, historical, and environmental parameters were recorded. Patients assessed how serious they perceived their conditions; and rated their degrees of pain, nausea, breathlessness, and anxiety on 10-cm visual analog scales (VASs). Testing was repeated prior to hospital discharge. Results: Twenty-five patients were enrolled. Of these, two (8%) were suspected by their emergency physicians to have insufficient capacity to give informed consent. However, five (20%) scored less than 5 on all of the WAIS-R subtests (kappa = 0.5) and eight (32%) scored less than 5 on at least one of the subtests (kappa = 0.3). The initial median Digit Span, Comprehension, and Similarities subtest scores were 7, 5, and 6. By discharge, these improved to 8, 7, and 8, respectively. Conclusions: This pilot study suggests that some patients with AMI may have difficulty processing information necessary to give informed consent for acute care research. Routine clinical evaluation may not detect this cognitive defect. Key words: informed consent; capacity; competency; myocardial infarction; Wechsler Adult Intelligence Scale-Revised (WAIS-R) test. ACADEMIC EMERGENCY MEDICINE 1999; 6:776-780 T HERE is a concern among some acute care researchers that informed consent is not always possible in acutely ill patients. While this concern initially centered around the comatose patient suffering from head injury 1,2 or cardiac arrest, it also extends to the conscious and alert patient under significant physical and psychological stress, such as those with an acute myocardial infarction 9, 1998; revisions received January 15, 1999, and February 12, 1999; accepted February 19, 1999 (AMI). Previous studies looking at the adequacy of informed consent for medical research have focused on the readability of the informed consent form or on the patient's memory of its content. [3][4][5] Standards for competency are usually described in terms of cognitive capacity. These standards are: evidencing a choice (realizing that there is a decision to be made), factual understanding of the issues, rational manipulation of information, and an appreciation of the nature of the situation. 6,7 To the authors' knowledge, no study has assessed the patient's cognitive capacity in the context of informed consent for acute care resear...

Informed consent for research in ICU obtained before ICU admission

“…However, we performed our informed-consent procedure before admission to ICU. Our patients were undergoing an elective cardiac surgery, and they were not in an emergency situation, in contrast to other studies [9]. However, we cannot exclude that some cognitive impairment could have been totally overlooked in our patients by the investigator.…”

“…Indeed, in ICU patients, the severity of illness, multiple treatments, the psychological burden and stressful environment may interfere with any of the three criteria and, therefore, may call into question the ethical value of the informed consent given. Many ICU patients may fail to understand the infor-mation delivered [9,10], or may be impaired in decision making [11,12].…”

Attitudes of Emergency Department Patients and Visitors Regarding Emergency Exception from Informed Consent in Resuscitation Research, Community Consultation, and Public Notification

“…We, therefore, thought is was important to study public opinion now that the regulations have been used in several studies. 16,20,[23][24][25][26] We asked five questions about willingness to participate in research without consent. These questions varied the circumstances to include research that involved both minimal risk and higher risk.…”

IRB Member Judgments of Decisional Capacity, Coercion, and Risk in Medical and Psychiatric Studies

“…Similar concerns regarding decisional capacity have been raised regarding research on medical disorders (Oldham et al, 1999). Various medical disorders have been identified in which decisional capacity may be compromised (Michaud, Murray, & Bloom, 2001), including cancer (Miller, 2001;Pereira, Hanson, & Bruera, 1997;Schaeffer et al, 1996), acute trauma (Cohen, McCue, & Green, 1993;Prentice, Antonson, Leibrock, Kelso, & Sears, 1993), cerebrovascular disease (Slyter, 1998), myocardial infarction (Smithline, Mader, & Crenshaw, 1999), diabetes (Strachan, Deary, Ewing, & Frier, 1997), and severe pain (Pearlman et al, 1993;Sullivan, Rapp, Fitzgibbon, & Chapman, 1997). In fact, recent estimates indicate that up to 40% of hospitalized medical patients may demonstrate diminished decisional capacity (Raymont et al, 2004).…”