Characteristics and Outcomes of Eligible Nonenrolled Patients in a Mechanical Ventilation Trial of Acute Respiratory Distress Syndrome
| العنوان: | Characteristics and Outcomes of Eligible Nonenrolled Patients in a Mechanical Ventilation Trial of Acute Respiratory Distress Syndrome |
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| المؤلفون: | Yaseen M. Arabi, Alexis F. Turgeon, Sangeeta Mehta, Deborah J. Cook, Qi Zhou, Niall D. Ferguson, Maureen O. Meade, Neill K. J. Adhikari, Andrea Matte, Kristin Brierley, Russell Graham, Orla Smith, Lori Hand |
| المصدر: | American Journal of Respiratory and Critical Care Medicine. 192:1306-1313 |
| بيانات النشر: | American Thoracic Society, 2015. |
| سنة النشر: | 2015 |
| مصطلحات موضوعية: | Male, Pulmonary and Respiratory Medicine, medicine.medical_specialty, medicine.medical_treatment, High-Frequency Ventilation, Critical Care and Intensive Care Medicine, Logistic regression, law.invention, Randomized controlled trial, law, Multicenter trial, medicine, Humans, Generalizability theory, Prospective Studies, Mechanical ventilation, Respiratory Distress Syndrome, Respiratory distress, business.industry, Patient Selection, High-frequency ventilation, Middle Aged, Respiration, Artificial, Patient recruitment, Treatment Outcome, Emergency medicine, Physical therapy, Female, business |
| الوصف: | Patients eligible for randomized controlled trials may not be enrolled for various reasons. Nonenrollment may affect study generalizability and lengthen the time required for trial completion.To describe characteristics and outcomes of eligible nonenrolled (ENE) patients in a multicenter trial of mechanical ventilation strategies.Within the OSCILLATE trial of high-frequency oscillation (HFO) versus conventional ventilation (CV) in adults with adult respiratory distress syndrome, and with approval from research ethics boards, we collected a minimal dataset on patients who satisfied eligibility criteria but were not enrolled. We categorized ENE patients as ENE-HFO and ENE-CV based on receipt of HFO at any time. We used multivariable logistic regression to assess the association between ENE status and mortality.A total of 548 patients were randomized, and 546 were ENE. The most common reasons for ENE were no consent (42%), physician refusal (24%), missed randomization window (15%), and current HFO use (14%). Compared with randomized patients in respective arms of the trial, ENE-HFO patients were younger and had worse lung injury, whereas ENE-CV patients had lower illness severity. ENE status was independently associated with mortality (adjusted odds ratio, 1.39; 95% confidence interval, 1.06-1.84; P = 0.02), with no significant interaction with ventilation treatment group.Nonenrollment was common, with approximately one ENE patient for every randomized patient. Our study suggests that enrollment in trials of mechanical ventilation may be associated with improved outcomes compared with standard care and highlights the need for prospective tracking and transparent reporting of ENE patients as part of trial management. |
| تدمد: | 1535-4970 1073-449X |
| DOI: | 10.1164/rccm.201501-0172oc |
| URL الوصول: | https://explore.openaire.eu/search/publication?articleId=doi_dedup___::e616134bb4a6ee5e9d2eb25e272a1afa https://doi.org/10.1164/rccm.201501-0172oc |
| Rights: | OPEN |
| رقم الانضمام: | edsair.doi.dedup.....e616134bb4a6ee5e9d2eb25e272a1afa |
| قاعدة البيانات: | OpenAIRE |
| تدمد: | 15354970 1073449X |
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| DOI: | 10.1164/rccm.201501-0172oc |