Developing Consensus on Clinical Outcomes for Children with Mild Pneumonia: A Delphi Study.

BACKGROUND: The absence of consensus for outcomes in pediatric antibiotic trials is a major barrier to research harmonization and clinical translation. We sought to develop expert consensus on study outcomes for clinical trials of children with mild community-acquired pneumonia (CAP). METHODS: Applying the Delphi method, a multispecialty expert panel ranked the importance of various components of clinical response and treatment failure outcomes in children with mild CAP for use in research. During Round 1, panelists suggested additional outcomes in open-ended responses that were added to subsequent rounds of consensus building. For Rounds 2 and 3, panelists were provided their own prior responses and summary statistics for each item in the previous round. The consensus was defined by >70% agreement. RESULTS: The expert panel determined that response to and failure of treatment should be addressed at a median of 3 days after initiation. Complete or substantial improvement in fever, work of breathing, dyspnea, tachypnea when afebrile, oral intake, and activity should be included as components of adequate clinical response outcomes. Clinical signs and symptoms including persistent or worsening fever, work of breathing, and reduced oral intake should be included in treatment failure outcomes. Interventions including receipt of parenteral fluids, supplemental oxygen, need for high-flow nasal cannula oxygen therapy, and change in prescription of antibiotics should also be considered in treatment failure outcomes. CONCLUSIONS: Clinical response and treatment failure outcomes determined by the consensus of this multidisciplinary expert panel can be used for pediatric CAP studies to provide objective data translatable to clinical practice.

Feasibility and reliability of telemedicine examinations for respiratory distress in children: A pilot study.

Respiratory disorders are a leading cause of acute care visits by children. Data establishing the reliability of telemedicine in evaluating children with respiratory concerns are limited. The overall objective of this pilot study was to evaluate the use of telemedicine to evaluate children with respiratory concerns. We performed a pilot prospective cohort study of children 12 to 71 months old presenting to the emergency department (ED) with lower respiratory tract signs and symptoms. Three examinations were performed simultaneously-one by the ED clinician with the patient, one by a remote ED clinician using telemedicine, and one by the child's parent. We evaluated measures of agreement between (a) the local and remote clinicians, (b) the local clinician and the parent, and (c) the parent and the remote clinician. Twenty-eight patients were enrolled (84 paired examinations). Except for heart rate, all examination findings evaluated (general appearance, capillary refill time, grunting, nasal flaring, shortness of breath, retractions, impression of respiratory distress, respiratory rate, and temperature) had acceptable or excellent agreement between raters. In this pilot study, we found that telemedicine respiratory examinations of young children are feasible and reliable, using readily available platforms and equipment.

Evaluation of intervertebral body implant performance using active surveillance of electronic health records.

Objectives: To assess the feasibility of using electronic health record (EHR) derived clinical data within an active surveillance setting to evaluate the safety of a novel intervertebral body implant (IVBI) stabilization device. Design: Retrospective, longitudinal observational cohort study comparing clinical outcomes for patients seen through 1 year following spinal fusion surgery. Setting: Lahey Health network, which includes academic tertiary hospitals, outpatient clinics, and independent provider offices in the New England region of the USA. Participants: All spine surgery patients aged 18 or older who underwent thoracic or lumbar spinal arthrodesis surgeries were included. Main outcome measures: The clinical outcomes of patients treated with the CONCORDE Bullet (CB) interbody spine system (DePuy) between April 2015 and December 2018 were compared with those patients receiving alternative spine stabilization interbody device implants. The primary endpoint was reoperation rate at 1 year, with secondary endpoints including the requirement for blood transfusion during index hospitalization, 1 year rate of any cause hospitalization, 1 year rate of surgical site infection, and mortality at 1 year. Results: Among the 606 patients undergoing thoracic or lumbar spinal fusion surgery during the study period, 136 received only the CB. In comparison with patients who did not receive the CB, no significant differences were found in the rate of reoperation at 1 year or the rates of secondary safety outcomes. Conclusions: Data derived from the EHR can be successfully leveraged to assess the safety of IVBI devices, in this case demonstrating no significant differences in the rates of risk-adjusted safety endpoints between patients undergoing spinal surgery with the CB as compared with alternative spinal implants.