Development of a core outcome set for therapeutic studies in eosinophilic esophagitis (COREOS).

BACKGROUND: End points used to determine treatment efficacy in eosinophilic esophagitis (EoE) have evolved over time. With multiple novel therapies in development for EoE, harmonization of outcomes measures will facilitate evidence synthesis and appraisal when comparing different treatments. OBJECTIVE: We sought to develop a core outcome set (COS) for controlled and observational studies of pharmacologic and diet interventions in adult and pediatric patients with EoE. METHODS: Candidate outcomes were generated from systematic literature reviews and patient engagement interviews and surveys. Consensus was established using an iterative Delphi process, with items voted on using a 9-point Likert scale and with feedback from other participants to allow score refinement. Consensus meetings were held to ratify the outcome domains of importance and the core outcome measures. Stakeholders were recruited internationally and included adult and pediatric gastroenterologists, allergists, dieticians, pathologists, psychologists, researchers, and methodologists. RESULTS: The COS consists of 4 outcome domains for controlled and observational studies: histopathology, endoscopy, patient-reported symptoms, and EoE-specific quality of life. A total of 69 stakeholders (response rate 95.8%) prioritized 42 outcomes in a 2-round Delphi process, and the final ratification meeting generated consensus on 33 outcome measures. These included measurement of the peak eosinophil count, Eosinophilic Esophagitis Histology Scoring System, Eosinophilic Esophagitis Endoscopic Reference Score, and patient-reported measures of dysphagia and quality of life. CONCLUSIONS: This interdisciplinary collaboration involving global stakeholders has produced a COS that can be applied to adult and pediatric studies of pharmacologic and diet therapies for EoE and will facilitate meaningful treatment comparisons and improve the quality of data synthesis.

Apixaban or Warfarin in Patients with an On-X Mechanical Aortic Valve.

BACKGROUND: Vitamin K antagonists are the only oral anticoagulants approved to prevent valve thrombosis and valve-related thromboembolism in patients with mechanical heart valves. Whether patients with an On-X mechanical aortic valve can be safely anticoagulated with apixaban is unknown. METHODS: Patients with an On-X aortic valve implanted at least 3 months before enrollment were randomly assigned to receive apixaban 5 mg twice daily or warfarin (target international normalized ratio 2.0 to 3.0). The primary efficacy end point was the composite of valve thrombosis or valve-related thromboembolism with coprimary analyses comparing apixaban with warfarin for noninferiority and comparing the apixaban event rate with an objective performance criterion (OPC). RESULTS: The trial was stopped after 863 participants were enrolled owing to an excess of thromboembolic events in the apixaban group. Most (94%) participants took aspirin. A total of 26 primary end-point events occurred, 20 (in 16 participants) in the apixaban group (4.2%/patient-year; 95% confidence interval [CI], 2.3 to 6.0) and 6 (in 6 participants) in the warfarin group (1.3%/patient-year; 95% CI, 0.3 to 2.3). The difference in primary end-point rates between the apixaban and warfarin groups was 2.9 (95% CI, 0.8 to 5.0); noninferiority and OPC success criteria were not met. Major bleeding rates were 3.6%/patient-year with apixaban and 4.5%/patient-year with warfarin. CONCLUSIONS: Apixaban did not demonstrate noninferiority to warfarin and is less effective than warfarin for the prevention of valve thrombosis or thromboembolism in patients with an On-X mechanical aortic valve. (Funded by Artivion; ClinicalTrials.gov number, NCT04142658.)

Electronic Health Record-Related Events in Medical Malpractice Claims.

BACKGROUND: There is widespread agreement that the full potential of health information technology (health IT) has not yet been realized and of particular concern are the examples of unintended consequences of health IT that detract from the safety of health care or from the use of health IT itself. The goal of this project was to obtain additional information on these health IT-related problems, using a mixed methods (qualitative and quantitative) analysis of electronic health record-related harm in cases submitted to a large database of malpractice suits and claims. METHODS: Cases submitted to the CRICO claims database and coded during 2012 and 2013 were analyzed. A total of 248 cases (<1%) involving health IT were identified and coded using a proprietary taxonomy that identifies user- and system-related sociotechnical factors. Ambulatory care accounted for most of the cases (146 cases). Cases were most typically filed as a result of an error involving medications (31%), diagnosis (28%), or a complication of treatment (31%). More than 80% of cases involved moderate or severe harm, although lethal cases were less likely in cases from ambulatory settings. Etiologic factors spanned all of the sociotechnical dimensions, and many recurring patterns of error were identified. CONCLUSIONS: Adverse events associated with health IT vulnerabilities can cause extensive harm and are encountered across the continuum of health care settings and sociotechnical factors. The recurring patterns provide valuable lessons that both practicing clinicians and health IT developers could use to reduce the risk of harm in the future. The likelihood of harm seems to relate more to a patient's particular situation than to any one class of error.

The impact of electronic health records on diagnosis.

Diagnostic error may be the largest unaddressed patient safety concern in the United States, responsible for an estimated 40,000-80,000 deaths annually. With the electronic health record (EHR) now in near universal use, the goal of this narrative review is to synthesize evidence and opinion regarding the impact of the EHR and health care information technology (health IT) on the diagnostic process and its outcomes. We consider the many ways in which the EHR and health IT facilitate diagnosis and improve the diagnostic process, and conversely the major ways in which it is problematic, including the unintended consequences that contribute to diagnostic error and sometimes patient deaths. We conclude with a summary of suggestions for improving the safety and safe use of these resources for diagnosis in the future.

Airway management and perioperative concerns in acromegaly patients undergoing endoscopic transsphenoidal surgery for pituitary tumors.

OBJECTIVES: Patients with acromegaly present unique challenges to cranial base surgery and anesthesia teams in the perioperative period, especially with regard to airway management. Abnormal airway anatomy may result from soft tissue hypertrophy and bony alterations. Additional perioperative challenges relate to the management of medical comorbidities. We aim to review perioperative airway concerns in acromegalic patients for the skull base surgeon in order to reduce preventable perioperative complications. STUDY DESIGN: Case series with chart review. SETTING: Tertiary care academic institution. SUBJECTS: Thirty-two acromegaly patients undergoing endoscopic transsphenoidal pituitary surgery. RESULTS: Videoscopic direct laryngoscopy intubation was required in 7 of 32 patients (21.9%) and fiberoptic intubation in 4 of 32 patients (12.5%). Overall failure rate for first intubation technique used was 12.5% (4/32). Cardiovascular comorbidities (hypertension and conduction abnormalities predominated) were present in 16 of 32 patients (50%), and obstructive sleep apnea, or other respiratory conditions, existed in 12 of 32 patients (37.5%). CONCLUSIONS: Acromegaly patients present a particular challenge to the endoscopic skull base surgeon. Despite preoperative anesthesia and otolaryngology evaluation, many of these patients will experience an unanticipated airway challenge during intubation. Preoperative preparation and perioperative awareness of anatomic and physiologic abnormalities of acromegalic patients is essential for successful endoscopic surgery in this unique population.