Alignment of site versus adjudication committee–based diagnosis with patient outcomes: Insights from the Providing Rapid Out of Hospital Acute Cardiovascular Treatment 3 trial

Sepehrvand, Nariman; Zheng, Yinggan; Armstrong, Paul W.; Welsh, Robert C.; Goodman, Shaun G.; Tymchak, Wayne; Khadour, Fadi; Chan, Michael; Weiss, Dale

doi:10.1177/1740774515601437

Cited by 14 publications

(13 citation statements)

References 31 publications

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“…The adjudication committee chair reviewed the case and assigned a diagnosis in the event of a disagreement. In order to replicate the clinical scenario, only information from the ED was available to adjudicators, including ED physician notes, consult notes, admission orders, ECG, and hospital‐based labs; the POC‐Troponin results from the ambulance were not available to the adjudicators . The final diagnosis of patients was further summarized into 4 categories: angina; acute coronary syndrome; acute heart failure; and “other.”…”

Section: Methodsmentioning

confidence: 99%

Providing Rapid Out of Hospital Acute Cardiovascular Treatment 4 (PROACT‐4)

Welsh

Weiss

Chan

et al. 2015

JAHA

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BackgroundWhether prehospital point‐of‐care (POC) troponin further accelerates the time to diagnosis in patients with chest pain (CP) is unknown. We conducted a randomized trial of POC‐Troponin testing in the ambulance.Methods and ResultsPatients with chest pain presenting by ambulance were randomized to usual care (UC) or POC‐Troponin; ST‐elevation myocardial infarction patients or those with noncardiovascular symptoms were excluded. Pre‐hospital high‐sensitivity troponin was analyzed on a POC device and available to the paramedic and emergency department (ED) staff. The final diagnosis was centrally adjudicated. The primary endpoint was time from first medical contact to discharge from ED or admission to hospital. We randomized 601 patients in 19 months; 296 to UC and 305 to POC‐Troponin. After ambulance arrival, the first troponin was available in 38 minutes in POC‐Troponin and 139 minutes in UC. In POC‐Troponin, the troponin was >0.01 ng/mL in 17.4% and >0.03 ng/mL in 9.8%. Patients spent a median of 9.0 hours from first medical contact to final disposition, and 165 (27.4%) were admitted to the hospital. The primary endpoint was shorter in patients randomized to POC‐Troponin (median 8.8 hours [6.2–10.8] compared to UC (median 9.1 hours [6.7–11.2]; P=0.05). There was no difference in the secondary endpoint of repeat ED visits, hospitalizations, or death in the next 30 days.ConclusionsIn this broad population of patients with CP, ambulance POC‐Troponin accelerated the time to final disposition. Enhanced and more cost‐effective early ED discharge of the majority of patients with CP calling 911 is an unrealized opportunity.Clinical Trial Registration URL: https://www.ClinicalTrials.gov/. Unique identifier: NCT01634425.

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Section: Methodsmentioning

confidence: 99%

Providing Rapid Out of Hospital Acute Cardiovascular Treatment 4 (PROACT‐4)

Welsh

Weiss

Chan

et al. 2015

JAHA

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“…In PROACT‐3 and ‐4 trials, the 30‐day events were captured by primary electronic and paper chart review . The adjudication diagnoses were used for index ED visits, and the ED diagnosis or the hospital discharge diagnosis was used for re‐hospitalization events.…”

Section: Methodsmentioning

confidence: 99%

Identifying Low‐risk Patients for Early Discharge From Emergency Department Without Using Subjective Descriptions of Chest Pain: Insights From Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) 3 and 4 Trials

Sepehrvand

Zheng

Armstrong

et al. 2017

Academic Emergency Medicine

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“…To reduce the potential for bias, in most cases, all suspected COEs should be adjudicated using standardized definitions by trained clinical events classification (CEC) reviewers blinded to treatment assignment. Although some controversy still exists about the need for CEC, with concerns centered around cost and the possibility that non-systematic or automated processes may provide a reasonable facsimile [2][3][4], CEC committees employing standardized definitions remain a key part of the gold standard process for systematic, precise, and reproducible event ascertainment and adjudication [5,6]. In addition, sponsors, investigators, and regulators are responsible for protecting patients from being harmed by experimental products during the conduct of clinical trials.…”

Section: Introductionmentioning

confidence: 99%

Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events

Wang

Haque

Thomas

et al. 2020

Trials

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Background: The primary goal of phase 2 and 3 clinical trials is to evaluate the safety and effectiveness of therapeutic interventions, and efficient and reproducible ascertainment of important clinical events, either as clinical outcome events (COEs) or adverse events (AEs), is critical. Clinical outcomes require consistency and clinical judgment, so these events are often adjudicated centrally by clinical events classification (CEC) physician reviewers using standardized definitions. In contrast, AEs are reported by sites to the trial coordinating center based on common reporting criteria set by regulatory authorities and trial sponsors. These different requirements have led to the development of separate tracks for COE and AE review.

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Alignment of site versus adjudication committee–based diagnosis with patient outcomes: Insights from the Providing Rapid Out of Hospital Acute Cardiovascular Treatment 3 trial

Abstract: Despite substantial agreement between the diagnosis of emergency department physicians and adjudication committee, in the subgroup of patients where there was disagreement, there was significantly worse short-term and long-term mortality.

Cited by 14 publications

References 31 publications

Providing Rapid Out of Hospital Acute Cardiovascular Treatment 4 (PROACT‐4)

Providing Rapid Out of Hospital Acute Cardiovascular Treatment 4 (PROACT‐4)

Identifying Low‐risk Patients for Early Discharge From Emergency Department Without Using Subjective Descriptions of Chest Pain: Insights From Providing Rapid Out of Hospital Acute Cardiovascular Treatment (PROACT) 3 and 4 Trials

Methods for safety and endpoint ascertainment: identification of adverse events through scrutiny of negatively adjudicated events

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