Andrew McRae

Objective: Paroxysmal supraventricular tachycardia (SVT) is a common dysrhythmia treated in the prehospital setting. Emergency medical service (EMS) agencies typically require patients treated for SVT to be transported to the hospital. This retrospective cohort study evaluated the impact, paramedic adherence, and patient re-presentation rates of a treat-and-release (T+R) protocol for uncomplicated SVT.Methods: Data were linked from the Alberta Health Services EMS electronic patient care record (EPCR) database for the City of Calgary to the Regional Emergency Department Information System (REDIS). All SVT patients treated by EMS between September 1, 2010, and September 30, 2012, were identified. Databases were queried to identify re-presentations to EMS or an emergency department (ED) within 72 hours of T+R.Results: There were 229 confirmed SVT patient encounters, including 75 T+R events. Of these 75 T+R events, 10 (13%, 95% confidence interval [CI] [7.4, 23]) led to an EMS re-presentation within 72 hours, and 4 (5%, 95% CI [2.1, 13]) led to an ED. All re-presentations were attributed to a single individual. After excluding 15 records that were incomplete due to limitations in the EPCR platform, 43 of 60 (72%) T+R encounters met all protocol criteria for T+R.Conclusion: The T+R protocol evaluated in this study applied to a significant proportion of patients presenting to EMS with SVT. Risk of re-presentation following T+R was low, and paramedic protocol adherence was reasonable. T+R appears to be a viable option for uncomplicated SVT in the prehospital setting.

While Canadian ED physicians discharge most syncope patients with no specific further follow-up, approximately 5% will suffer serious outcomes after ED discharge. The goal of this study is to prospectively identify risk factors and to derive a clinical decision tool to accurately predict those at risk for serious outcomes after ED discharge within 30 days. We will conduct a prospective cohort study at 6 Canadian EDs to include adults with syncope and exclude patients with loss of consciousness > 5 minutes, mental status changes from baseline, obvious witnessed seizure, or head trauma prior to syncope. Emergency physicians will collect standardized clinical variables including historical features, physical findings, and results of immediately available tests (blood, ECG, and ED cardiac monitoring) prior to ED discharge/hospital admission. A second emergency physician will evaluate approximately 10% of study patients for interobserver agreement calculation of predictor variables. The primary outcome will be a composite serious outcome occurring within 30 days of ED discharge and includes three distinct categories: serious adverse events (death, arrhythmia); identification of serious underlying disease (structural heart disease, aortic dissection, pulmonary embolism, severe pulmonary hypertension, subarachnoid hemorrhage, significant hemorrhage, myocardial infarction); or procedures to treat the cause of syncope. The secondary outcome will be any of the above serious outcomes either suspected or those occurring in the ED. A blinded Adjudication Committee will confirm all serious outcomes. Univariate analysis will be performed to compare the predictor variables in patients with and without primary outcome. Variables with p-values <0.2 and kappa values ≥0.60 will be selected for stepwise logistic regression to identify the risk factors and to develop the clinical decision tool. We will enroll 5,000 patients (with 125 positive for primary outcome) for robust identification of risk factors and clinical decision tool development. Once successfully developed, this tool will accurately risk-stratify adult syncope patients; however, validation and implementation will still be required. This program of research should lead to standardized care of syncope patients, and improve patient safety.

Advances in ultrasound imaging technology have made it more accessible to prehospital providers. Little is known about how ultrasound is being used in the prehospital environment and we suspect that it is not widely used in North America at this time. We believe that EMS system characteristics such as provider training, system size, population served, and type of transport will be associated with use or non-use of ultrasound. Our study objective was to describe the current use of prehospital ultrasound in North America. This study was a cross-sectional survey distributed to EMS directors on the National Association of EMS Physicians (NAEMSP) mailing list. Respondents had the option to complete a paper or electronic survey. Of the 755 deliverable surveys we received 255 responses from across Canada and the United states for an overall response rate of 30%. Of respondents, 4.1% of EMS systems (95% CI 1.9, 6.3) reported currently using ultrasound and an additional 21.7% (95% CI 17, 26.4) are considering implementing ultrasound. EMS services using ultrasound have a higher proportion of physicians (p < 0.001) as their highest trained prehospital providers when compared to the survey group as a whole. The most commonly cited current and projected applications are Focused Abdominal Sonography for Trauma (FAST) and assessment of pulseless electrical activity (PEA) arrest. The cost of equipment and training are the most significant barriers to implementation of ultrasound. Most medical directors want evidence that prehospital ultrasound improves patient outcomes prior to implementation. Prehospital ultrasound is infrequently used in North America and there are a number of barriers to its implementation, including costs of equipment and training and limited evidence demonstrating improved outcomes. A research agenda for prehospital ultrasound should focus on patient-important outcomes such as morbidity and mortality. Two commonly used indications that could be a focus of standardized training programs are the FAST exam, and assessment of PEA arrest.

Cluster randomized trials (CRTs) present unique ethical challenges. In the absence of a uniform standard for their ethical design and conduct, problems such as variability in procedures and requirements by different research ethics committees will persist. We aimed to assess the need for ethics guidelines for CRTs among research ethics chairs internationally, investigate variability in procedures for research ethics review of CRTs within and among countries, and elicit research ethics chairs’ perspectives on specific ethical issues in CRTs, including the identification of research subjects. The proper identification of research subjects is a necessary requirement in the research ethics review process, to help ensure, on the one hand, that subjects are protected from harm and exploitation, and on the other, that reviews of CRTs are completed efficiently.

Cluster randomized trials (CRTs) pose ethical challenges for investigators and ethics committees. This study describes the views and experiences of CRT researchers with respect to: (1) ethical challenges in CRTs; (2) the ethics review process for CRTs; and (3) the need for comprehensive ethics guidelines for CRTs.

Objective Cluster randomised trial (CRT) investigators face challenges in seeking informed consent from individual patients (cluster members). This study examined associations between reporting of patient consent in healthcare CRTs and characteristics of these trials. Study design Consent practices and study characteristics were abstracted from a random sample of 160 CRTs performed in primary or hospital care settings that were published from 2000 to 2008. Multivariable logistic regression was used to examine associations between reporting of patient consent and methodological characteristics, as well as publication features such as date and journal of publication. Results 82 (53.8%) of 160 studies reported obtaining informed consent from individual patients. Reporting of patient consent was independently and positively associated with: smaller cluster size, the evaluation of experimental interventions targeted at patients, data collection from individual patients, publication later than 2004 and publication in higher-impact journals. Conclusions Reporting of consent practices in published CRTs should be improved. Consent practices in published CRTs appear to be related to the type of interventions under study, as well as journal impact and trends in research ethics practices. These findings will inform best practices in trial conduct and ethics review, remediation of errors in consent practices and ethics review and the development of regulatory guidance for CRTs.

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the sixth of the questions posed, namely, what is the role and authority of gatekeepers in CRTs in health research? ‘Gatekeepers’ are individuals or bodies that represent the interests of cluster members, clusters, or organizations. The need for gatekeepers arose in response to the difficulties in obtaining informed consent because of cluster randomization, cluster-level interventions, and cluster size. In this paper, we call for a more restrictive understanding of the role and authority of gatekeepers. Previous papers in this series have provided solutions to the challenges posed by informed consent in CRTs without the need to invoke gatekeepers. We considered that consent to randomization is not required when cluster members are approached for consent at the earliest opportunity and before any study interventions or data-collection procedures have started. Further, when cluster-level interventions or cluster size means that obtaining informed consent is not possible, a waiver of consent may be appropriate. In this paper, we suggest that the role of gatekeepers in protecting individual interests in CRTs should be limited. Generally, gatekeepers do not have the authority to provide proxy consent for cluster members. When a municipality or other community has a legitimate political authority that is empowered to make such decisions, cluster permission may be appropriate; however, gatekeepers may usefully protect cluster interests in other ways. Cluster consultation may ensure that the CRT addresses local health needs, and is conducted in accord with local values and customs. Gatekeepers may also play an important role in protecting the interests of organizations, such as hospitals, nursing homes, general practices, and schools. In these settings, permission to access the organization relies on resource implications and adherence to institutional policies.

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the cluster trial is to be set on a firm ethical foundation. This paper addresses the second of the questions posed, namely, from whom, when, and how must informed consent be obtained in CRTs in health research? The ethical principle of respect for persons implies that researchers are generally obligated to obtain the informed consent of research subjects. Aspects of CRT design, including cluster randomization, cluster level interventions, and cluster size, present challenges to obtaining informed consent. Here we address five questions related to consent and CRTs: How can a study proceed if informed consent is not possible? Is consent to randomization always required? What information must be disclosed to potential subjects if their cluster has already been randomized? Is passive consent a valid substitute for informed consent? Do health professionals have a moral obligation to participate as subjects in CRTs designed to improve professional practice?

This article is part of a series of papers examining ethical issues in cluster randomized trials (CRTs) in health research. In the introductory paper in this series, we set out six areas of inquiry that must be addressed if the CRT is to be set on a firm ethical foundation. This paper addresses the first of the questions posed, namely, who is the research subject in a CRT in health research? The identification of human research subjects is logically prior to the application of protections as set out in research ethics and regulation. Aspects of CRT design, including the fact that in a single study the units of randomization, experimentation, and observation may differ, complicate the identification of human research subjects. But the proper identification of human research subjects is important if they are to be protected from harm and exploitation, and if research ethics committees are to review CRTs efficiently.