Neurology/original research
External Validation of the San Francisco Syncope Rule

https://doi.org/10.1016/j.annemergmed.2006.11.012Get rights and content

Study objective

We externally validate the ability of the San Francisco Syncope Rule to accurately identify syncope patients who will experience a 7-day serious clinical event.

Methods

Patients who presented to a single academic emergency department (ED) between 8 am and 10 pm with syncope or near-syncope were prospectively enrolled. Treating physicians recorded the presence or absence of all San Francisco Syncope Rule risk factors. Patients were contacted by telephone at 14 days for a structured interview. A 3-physician panel, blinded to the San Francisco Syncope Rule score, reviewed ED medical records, hospital records, and telephone interview forms to identify predefined serious clinical events. The primary outcome was the ability of the San Francisco Syncope Rule to predict any 7-day serious clinical event. A secondary outcome was the ability of the San Francisco Syncope Rule to predict 7-day serious clinical events that were not identified during the initial ED evaluation.

Results

Of 592 eligible patients, 477 (81%) provided informed consent. Direct telephone contact or admission/outpatient records were successfully obtained for 463 (97%) patients. There were 56 (12%) patients who had a serious 7-day clinical event, including 16 (3%) who received a diagnosis after the initial ED evaluation. Sensitivity and specificity of the San Francisco Syncope Rule for the primary outcome were 89% (95% confidence interval [CI] 81% to 97%) and 42% (95% CI 37% to 48%), respectively, and 69% (95% CI 46% to 92%) and 42% (95% CI 37% to 48%), respectively, for the secondary outcome. Estimates of sensitivity were minimally affected by missing data and most optimistic assumptions for missing follow-up information.

Conclusion

In this external validation cohort, the San Francisco Syncope Rule had a lower sensitivity and specificity than in previous reports.

Introduction

Syncope, defined as a transient loss of consciousness, may herald life-threatening events. As a result, patients presenting with syncope to emergency departments (EDs) are frequently hospitalized. Syncope accounts for 1% to 3% of all ED visits and hospital admissions from the ED.1, 2, 3, 4, 5, 6, 7 Unfortunately, current admission practices result in marginal diagnostic and therapeutic benefit8, 9 and consume enormous health care resources. Between 39% and 50% of admitted patients are discharged without an explanation for syncope,4, 10 and syncope-related admissions in the United States account for $2.4 billion in annual health care costs.11

The San Francisco Syncope Rule is an instrument designed to identify patients with syncope or near-syncope who are at low risk of a short-term, serious clinical event.12, 13 Low-risk patients can potentially be discharged for an outpatient evaluation of syncope. The San Francisco Syncope Rule predictors include an abnormal ECG result, complaint of shortness of breath, hematocrit level less than 30%, systolic blood pressure less than 90 mm Hg, and a history of congestive heart failure.

In a derivation study, outcomes included any predefined clinical events within 7 days; the San Francisco Syncope Rule demonstrated 96% sensitivity (95% confidence interval [CI] 92% to 100%) and 62% specificity (95% CI 58% to 66%).12 In a validation study, outcomes included 30-day predefined events that were diagnosed after the ED visit; the San Francisco Syncope Rule demonstrated 98% sensitivity (95% CI 89% to 100%) and 56% specificity (95% CI 52% to 60%).13 These studies suggest that application of the San Francisco Syncope Rule may safely decrease syncope-related admissions by 7% to 10%.

The published San Francisco Syncope Rule derivation and validation studies have been performed at the same institution. Our goal was to evaluate the accuracy of the San Francisco Syncope Rule to identify “low-risk” patients in an independent, prospective validation sample. The primary outcome included all 7-day serious clinical events. The secondary outcome included 7-day serious clinical events that were diagnosed only after the index ED visit. Analysis of the secondary outcome is important because there is little clinical utility in “predicting” serious conditions that are evident at the ED evaluation.

Section snippets

Study Design and Setting

This was a single-center, prospective, observational, cohort study that enrolled patients from April 18, 2005, to April 18, 2006. The study site is an urban, academic, Level I trauma center with an emergency medicine residency and an annual volume of 40,000 visits. The study site institutional review board approved the research protocol.

Selection of Participants

Adult patients with a complaint of syncope or near-syncope were eligible for enrollment. Syncope is defined as a sudden, transient loss of consciousness.

Results

Of the 709 patients who were screened during the study period, 592 (83%) were eligible, and 477 (81%) provided informed consent to participate. We found no important differences in age, sex, race, or ethnicity between eligible patients who provided or declined informed consent. Direct telephone follow-up was obtained in 436 patients (91%). Of the remaining 41 patients, 27 (6% of the entire cohort) had available inpatient or outpatient data for at least 2 weeks after the date of enrollment, and

Limitations

We performed a prospective cohort study designed to minimize missing data bias and maximize direct patient follow-up with a standardized protocol. Nevertheless, there are potential limitations to our study.

We excluded children, patients with DNR/DNI status, and patients without follow-up contact information, whereas these were not exclusion criteria used by the San Francisco Syncope Rule investigators. It is possible that the San Francisco Syncope Rule demonstrated different test

Discussion

We performed a prospective cohort study to externally validate the San Francisco Syncope Rule. Study strengths include a protocol to minimize missing ECG data, high rates of direct patient follow-up, a physician outcomes review panel that was blinded to data recorded by treating physicians, and explicit methods for assessing the effects of missing data on San Francisco Syncope Rule predictors and missing follow-up information. At our institution, physician application of the San Francisco

References (20)

There are more references available in the full text version of this article.

Cited by (103)

  • Clinical Benefit of Hospitalization for Older Adults With Unexplained Syncope: A Propensity-Matched Analysis

    2019, Annals of Emergency Medicine
    Citation Excerpt :

    This does not directly change practice but suggests that we may be able to safely discharge more syncope patients. Despite substantial research efforts to develop and validate accurate risk-stratification tools,4-10 there remains considerable uncertainty in regard to which patients with syncope can be safely discharged from the ED.11 Greater than 30% of these visits result in hospitalization; for older adults (≥60 years), this proportion is greater than 50%.12

View all citing articles on Scopus

Supervising editor: Allan B. Wolfson, MD

Author contributions: BCS, CMM, JRH, and WRM conceived the study. BCS and CMM obtained funding for this study. BCS, GM, TW, GZS, GZ, and SS were responsible for data collection, and BCS supervised the overall data collection process. BCS performed the data analysis and drafted the article. All authors contributed substantially to article revisions. BCS takes responsibility for the paper as a whole.

Michael Callaham, MD, recused himself from the editorial decision process for this article.

Funding and support: This study was supported by the UCLA Robert Wood Johnson Clinical Scholars Program (050721). Dr Sun is supported by a UCLA National Institute of Aging K12 award (K12AG001004) and an American Geriatrics Society Dennis Jahnigen Career Development Award. Dr Mangione was also partially supported by the UCLA Center for Health Improvement in Minority Elders/Resource Centers for Minority Aging Research, NIH/NIA (AG 02-004).

Available online January 8, 2007.

Reprints not available from the authors.

View full text