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1.
N Engl J Med ; 387(19): 1759-1769, 2022 Nov 10.
Article in English | MEDLINE | ID: mdl-36278971

ABSTRACT

BACKGROUND: Invasive mechanical ventilation in critically ill adults involves adjusting the fraction of inspired oxygen to maintain arterial oxygen saturation. The oxygen-saturation target that will optimize clinical outcomes in this patient population remains unknown. METHODS: In a pragmatic, cluster-randomized, cluster-crossover trial conducted in the emergency department and medical intensive care unit at an academic center, we assigned adults who were receiving mechanical ventilation to a lower target for oxygen saturation as measured by pulse oximetry (Spo2) (90%; goal range, 88 to 92%), an intermediate target (94%; goal range, 92 to 96%), or a higher target (98%; goal range, 96 to 100%). The primary outcome was the number of days alive and free of mechanical ventilation (ventilator-free days) through day 28. The secondary outcome was death by day 28, with data censored at hospital discharge. RESULTS: A total of 2541 patients were included in the primary analysis. The median number of ventilator-free days was 20 (interquartile range, 0 to 25) in the lower-target group, 21 (interquartile range, 0 to 25) in the intermediate-target group, and 21 (interquartile range, 0 to 26) in the higher-target group (P = 0.81). In-hospital death by day 28 occurred in 281 of the 808 patients (34.8%) in the lower-target group, 292 of the 859 patients (34.0%) in the intermediate-target group, and 290 of the 874 patients (33.2%) in the higher-target group. The incidences of cardiac arrest, arrhythmia, myocardial infarction, stroke, and pneumothorax were similar in the three groups. CONCLUSIONS: Among critically ill adults receiving invasive mechanical ventilation, the number of ventilator-free days did not differ among groups in which a lower, intermediate, or higher Spo2 target was used. (Supported by the National Heart, Lung, and Blood Institute and others; PILOT ClinicalTrials.gov number, NCT03537937.).


Subject(s)
Critical Illness , Oxygen , Respiration, Artificial , Adult , Humans , Critical Illness/therapy , Hospital Mortality , Intensive Care Units , Oxygen/administration & dosage , Oxygen/blood , Oxygen/therapeutic use , Respiration, Artificial/methods , Critical Care/methods , Cross-Over Studies , Emergency Service, Hospital , Academic Medical Centers , Oximetry
2.
AJOB Empir Bioeth ; 10(4): 215-221, 2019.
Article in English | MEDLINE | ID: mdl-31593523

ABSTRACT

Introduction: Patient advocacy organizations (PAOs) provide patient education, raise public awareness, and influence health policy for a wide range of diseases. These organizations frequently receive financial support form from drug, device, and biotechnology companies. Though PAOs often develop policies to address institutional conflicts of interest arising from industry relations, little is known about the substance of these policies. Methods: We sampled all PAOs that are members of the National Health Council. Using a standardized search strategy, all policies were obtained from each organization if publicly available. We reviewed policies for content related to restrictions on corporate partnerships, disclosure of corporate funding, and governance and monitoring of corporate partnerships. Results: We found that 24 of 47 (51%) organizations had policies that addressed institutional conflict of interest. A total of 9 of those 24 (38%) policies placed any restriction on the types of corporations that the PAO would or would not partner with. While 16 of the 24 (67%) outlined some process for disclosure of the organization's corporate donors, only 5 of 24 (21%) specified a manner for disclosing the financial value of those donations. Further, 15 of the 24 (63%) policies identified the person or persons responsible for approving corporate partnerships. However, 17 (71%) failed to address or specify the person(s) responsible for ongoing review of those partnerships. Conclusion: Nearly half of the organizations studied did not have publicly available conflict of interest policies. Among those that did, few policies had a substantial level of detail or limitations to guard against conflicts of interest.


Subject(s)
Conflict of Interest , Disclosure/ethics , Information Dissemination/ethics , Patient Advocacy/ethics , Patient Advocacy/statistics & numerical data , Biomedical Research , Disclosure/statistics & numerical data , Drug Industry/ethics , Humans , Organizational Policy , Trust
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