Neal W. Dickert

Patient-Centered Imaging: Shared Decision Making for Cardiac Imaging Procedures With Exposure to Ionizing Radiation

The current paper details the recommendations arising from an NIH-NHLBI/NCI-sponsored symposium held in November 2012, aiming to identify key components of a radiation accountability framework fostering patient-centered imaging and shared decision-making in cardiac imaging. Symposium participants, working in 3 tracks, identified key components of a framework to target critical radiation safety issues for the patient, the laboratory, and the larger population of patients with known or suspected cardiovascular disease. The use of ionizing radiation during an imaging procedure should be disclosed to all patients by the ordering provider at the time of ordering, and reinforced by the performing provider team. An imaging protocol with effective dose ≤3 mSv is considered very low risk, not warranting extensive discussion or written informed consent. However, a protocol effective dose >20 mSv was proposed as a level requiring particular attention in terms of shared decision-making and either formal discussion or written informed consent. Laboratory reporting of radiation dosimetry is a critical component of creating a quality laboratory fostering a patient-centered environment with transparent procedural methodology. Efforts should be directed to avoiding testing involving radiation, in patients with inappropriate indications. Standardized reporting and diagnostic reference levels for computed tomography and nuclear cardiology are important for the goal of public reporting of laboratory radiation dose levels in conjunction with diagnostic performance. The development of cardiac imaging technologies revolutionized cardiology practice by allowing routine, noninvasive assessment of myocardial perfusion and anatomy. It is now incumbent upon the imaging community to create an accountability framework to safely drive appropriate imaging utilization.

Cardiac Arrest: A Treatment Algorithm for Emergent Invasive Cardiac Procedures in the Resuscitated Comatose Patient.

Patients who are comatose after cardiac arrest continue to be a challenge, with high mortality. Although there is an American College of Cardiology Foundation/American Heart Association Class I recommendation for performing immediate angiography and percutaneous coronary intervention (when indicated) in patients with ST-segment elevation myocardial infarction, no guidelines exist for patients without ST-segment elevation. Early introduction of mild therapeutic hypothermia is an established treatment goal. However, there are no established guidelines for risk stratification of patients for cardiac catheterization and possible percutaneous coronary intervention, particularly in patients who have unfavorable clinical features in whom procedures may be futile and affect public reporting of mortality. An algorithm is presented to improve the risk stratification of these severely ill patients with an emphasis on consultation and evaluation of patients prior to activation of the cardiac catheterization laboratory.

Understanding respect: learning from patients

Background: The importance of respecting patients and participants in clinical research is widely recognised. However, what it means to respect persons beyond recognising them as autonomous is unclear, and little is known about what patients find to be respectful. Objective: To understand patients’ conceptions of respect and what it means to be respected by medical providers. Design: Qualitative study from an academic cardiology clinic, using semistructured interviews with 18 survivors of sudden cardiac death. Results: Patients believed that respecting persons incorporates the following major elements: empathy, care, autonomy, provision of information, recognition of individuality, dignity and attention to needs. Conclusions: Making patients feel respected, or valued as a person, is a multi-faceted task that involves more than recognising autonomy. While patients’ views of respect do not determine what respect means, these patients expressed important intuitions that may be of substantial conceptual relevance.

Implementation of the Exception From Informed Consent Regulations in a Large Multicenter Emergency Clinical Trials Network: The RAMPART Experience

Clinical trials investigating therapies for acutely and critically ill and injured patients in the earliest phases of treatment often can only be performed under regulations allowing for exception from informed consent (EFIC) for emergency research. Implementation of these regulations in multicenter clinical trials involves special challenges and opportunities. The Rapid Anticonvulsant Medication Prior to Arrival Trial (RAMPART), the first EFIC trial conducted by the Neurological Emergencies Treatment Trials (NETT) network, combined centralized resources and coordination with retention of local control and flexibility to facilitate compliance with the EFIC regulations. Specific methods used by the NETT included common tools for community consultation and public disclosure, sharing of experiences and knowledge, and reporting of aggregate results. Tracking of community consultation and public disclosure activities and feedback facilitates empirical research on EFIC methods in the network and supports quality improvements for future NETT trials. The NETT model used in RAMPART demonstrates how EFIC may be effectively performed in established clinical trial networks.

Consulting communities when patients cannot consent: a multicenter study of community consultation for research in emergency settings.

Objectives:To assess the range of responses to community consultation efforts conducted within a large network and the impact of different consultation methods on acceptance of exception from informed consent research and understanding of the proposed study. Design:A cognitively pretested survey instrument was administered to 2,612 community consultation participants at 12 U.S. centers participating in a multicenter trial of treatment for acute traumatic brain injury. Setting:Survey nested within community consultation for a phase III randomized controlled trial of treatment for acute traumatic brain injury conducted within a multicenter trial network and using exception from informed consent. Subjects:Adult participants in community consultation events. Interventions:Community consultation efforts at participating sites. Measurements and Main Results:Acceptance of exception from informed consent in general, attitude toward personal exception from informed consent enrollment, and understanding of the study content were assessed. Fifty-four percent of participants agreed exception from informed consent enrollment was acceptable in general in the proposed study; 71% were accepting of personal exception from informed consent enrollment. Participants in interactive versus noninteractive community consultation events were more accepting of exception from informed consent in general (63% vs 49%) and personal exception from informed consent inclusion (77% vs 67%). Interactive community consultation participants had high-level recall of study content significantly more often than noninteractive consultation participants (77% vs 67%). Participants of interactive consultation were more likely to recall possible study benefits (61% vs 45%) but less likely to recall potential risks (56% vs 69%). Conclusions:Interactive community consultation methods were associated with increased acceptance of exception from informed consent and greater overall recall of study information but lower recall of risks. There was also significant variability in exception from informed consent acceptance among different interactive consultation events. These findings have important implications for institutional review board and investigators conducting exception from informed consent research and for community engagement efforts in research more generally.

Cerebral Oximetry as a Real-Time Monitoring Tool to Assess Quality of In-Hospital Cardiopulmonary Resuscitation and Post Cardiac Arrest Care.

Background Regional cerebral oxygen saturation (rSO2) as assessed by near infrared frontal cerebral spectroscopy decreases in circulatory arrest and increases with high-quality cardiopulmonary resuscitation. We hypothesized that higher rSO2 during cardiopulmonary resuscitation and after return of spontaneous circulation (ROSC) would predict survival to discharge and neurological recovery. Methods and Results This prospective case series included patients experiencing in-hospital cardiac arrest. Cerebral oximetry was recorded continuously from initiation of resuscitation until ROSC and up to 48 hours post-arrest. Relationships between oximetry data during these time periods and outcomes of resuscitation survival and survival to discharge were analyzed. The cohort included 27 patients. Nineteen (70.3%) achieved ROSC, and 8 (29.6%) survived to discharge. Median arrest duration was 20.8 minutes (range =8 to 74). There was a significant difference in rSO2 between resuscitation survivors and resuscitation nonsurvivors at initiation of the resuscitative efforts (35% versus 17.5%, P =0.03) and during resuscitation (36% versus 15%, P =0.0008). No significant association was observed between rSO2 at ROSC or during the post-arrest period and survival to discharge. Among patients who survived to discharge, there was no association between cerebral performance category and rSO2 at ROSC, during resuscitation, or post-arrest. Conclusions Higher rSO2 levels at initiation of resuscitation and during resuscitation are associated with resuscitation survival and may reflect high-quality cardiopulmonary resuscitation. However, in this small series, rSO2 was not predictive of good neurological outcome. Larger studies are needed to determine whether this monitoring modality can be used to improve clinical outcomes.

Patients' perspectives of enrollment in research without consent: the patients' experiences in emergency research-progesterone for the treatment of traumatic brain injury study.

Objective:Research in acute illness often requires an exception from informed consent. Few studies have assessed the views of patients enrolled in exception from informed consent trials. This study was designed to assess the views of patients and their surrogates of exception from informed consent enrollment within the context of a randomized, placebo-controlled trial of an investigational agent for traumatic brain injury. Design:Interactive interview study. Setting:Nested within the Progesterone for the Treatment of Traumatic Brain Injury trial, a Phase III randomized controlled trial in acute traumatic brain injury. Subjects:Patients and surrogates (for patients incapable of being interviewed) enrolled in Progesterone for the Treatment of Traumatic Brain Injury under exception from informed consent at 12 sites. Interventions:None. Measurements and Main Results:Interviews focused on respondents’ acceptance of exception from informed consent enrollment in Progesterone for the Treatment of Traumatic Brain Injury, use of placebo and randomization, understanding of major study elements, and views regarding regulatory protections. Descriptive statistical analysis was performed; textual data were analyzed thematically. Eighty-five individuals were interviewed. Eighty-four percent had positive attitudes toward Progesterone for the Treatment of Traumatic Brain Injury inclusion. Seventy-eight percent found their inclusion under exception from informed consent acceptable, and 72% found use of exception from informed consent in Progesterone for the Treatment of Traumatic Brain Injury acceptable in general. Only two respondents clearly disagreed with both personal and general exception from informed consent enrollment. The most common concerns (26%) related to absence of consent. Eighty percent and 92% were accepting of placebo use and randomization, respectively. Although there were few black respondents (n = 11), they were less accepting of personal exception from informed consent enrollment than white respondents (55% vs 83%; p = 0.0494). Conclusions:Acceptance of exception from informed consent in this placebo-controlled trial of an investigational agent was high and exceeded acceptance among community consultation participants. Exception from informed consent enrollment appears generally consistent with patients’ preferences.

Learning From Experience: A Systematic Review of Community Consultation Acceptance Data

STUDY OBJECTIVE Federal regulations permitting an exception from informed consent for research in emergency settings require community consultation before study approval. Rates of acceptance of exception from informed consent in community consultation are often reported, but predictors of acceptance are not well understood, and investigators and institutional review boards struggle to interpret and use acceptance data. METHODS We systematically reviewed empirical literature on community consultation for exception from informed consent trials in the PubMed, EMBASE, and Web of Science databases. We included peer-reviewed articles reporting acceptance data from community consultation for US exception from informed consent trials. Questions were categorized by enrollment focus (eg, personal enrollment versus more general exception from informed consent acceptance), and observed acceptance was compared across studies. We also compared potential predictors of acceptance, including demographic factors, consultation method, and target community. RESULTS Nine studies (total n=9,036 participants) were included in the final analysis. Personal acceptance of enrollment in the proposed exception from informed consent study ranged from 45% to 93% and clustered in the range of 64% to 80%. Acceptance of the exception from informed consent mechanism in general (without reference to personal inclusion) was lower (35% to 84%) than personal acceptance. The effect of demographic characteristics on acceptance was inconsistent, and meeting-based consultation methods were associated with greater acceptance than survey-based methods. Finally, acceptance rates varied substantially according to the phrasing of the question. CONCLUSION Personal acceptance clustered between 64% and 80%. This range may be informative for institutional review boards and investigators evaluating community consultation results. However, numerous factors affect acceptance, and there is a need for considerable caution against overreliance on acceptance data.

Involving patients in enrolment decisions for acute myocardial infarction trials

Seriously ill patients requiring emergency treatment are unlikely to be able to give full informed consent for a clinical trial, but Neal W Dickert and Franklin G Miller argue that this does not mean that they shouldn’t be involved in enrolment decisions at all

Re-Visiting Consent for Clinical Research on Acute Myocardial Infarction and Other Emergent Conditions

Clinical trials in acute myocardial infarction (AMI) and other urgent or emergent conditions present special challenges regarding informed consent. Available data suggest patients often poorly understand such research when they are offered enrollment, and unalterable factors such as time constraints and emotional and physical distress create barriers to informed consent on the part of patients and surrogates. We examine the challenges to informed consent in AMI trials in particular and suggest that full informed consent may not be a realistic goal. We propose instead a model of informed refusal, offering patients an informed opportunity to refuse participation rather than requesting a positive commitment to participate. Informed refusal may be both more achievable and more respectful of patients, and we describe how such a process might be implemented and evaluated. We also suggest a need for regulatory change in order to maximize effective patient participation in decisions for clinical research in AMI and other acute illnesses.