Huge variation in obtaining ethical permission for a non-interventional observational study in Europe.

BACKGROUND: Ethical approval (EA) must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. METHODS: Sixteen European national coordinators (NCs) of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. RESULTS: N = 8/16 of the NCs could apply at one single national ethical committee (EC), while the others had to apply to various regional ECs and/or individual hospital institutional research boards (IRBs). The time between applying for EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were (very) unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. DISCUSSION: Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. CONCLUSION: Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries.

Selective Necrosectomy for Infected Pancreatic Necrosis.

BACKGROUND: Until recently, a diagnosis of infected pancreatic necrosis (IPN) warranted necrosectomy, which was associated with high morbidity and mortality rates greater than 20%. Preoperative percutaneous drainage delayed the need for necrosectomy with improved outcomes. METHODS: In 2008, this institution changed its approach to the management of such cases opting instead for percutaneous drainage with selective deferred necrosectomy. A total of 38 consecutive patients with IPN from January 2008 to December 2014 were included. RESULTS: All 38 underwent percutaneous radiological drainage, and selective necrosectomy was performed on 15 where the infected necrosis did not completely resolve. Twenty-three patients did not require surgery and were managed with pancreatic drain insertion, optimal nutritional support and critical care interventions. Median peak Acute Physiology and Chronic Health Evaluation and Sequential Organ Failure Assessment scores were 10 (range 0-18) and 3 (range 0-10) prior to radiological intervention. Overall mortality was 5% (n = 2). CONCLUSION: This study demonstrates that radiological-guided drainage of infected pancreatic collections can, in most cases, prove curative and, if not, facilitates delayed surgical intervention with improved outcomes.

Epidemiology, clinical characteristics and resource implications of pandemic (H1N1) 2009 in intensive care units in Ireland.

OBJECTIVE: To describe the incidence, clinical characteristics and outcomes of critically ill patients in Ireland with pandemic (H1N1) 2009 infection, and to provide a dynamic assessment of the burden of such cases on Irish intensive care units. DESIGN, SETTING AND PARTICIPANTS: Multicentre prospective observational study of all adult patients admitted to any of the 30 ICUs in the Republic of Ireland between 15 July 2009 and 30 May 2010. MAIN OUTCOME MEASURES: Patient demographics, clinical characteristics and ICU mortality; ICU admissions, bed-days, bed occupancy rates and distribution. RESULTS: Seventy-seven adult patients with pandemic (H1N1) 2009 infection were admitted to 27 of 30 Irish ICUs. The median age was 43 years (IQR, 30-56 years); 67 patients (88%) were aged under 65; 39 (51%) were male. Sixty-two patients (82%) had comorbid conditions, including obesity (36%), respiratory disease (34%) and malignancy or immunosuppression (20%). Eight (11%) were pregnant, and 27 (36%) were smokers. Sixty-seven patients were mechanically ventilated, 24 (32%) required renal replacement therapy, 39 (51%) received vasopressors and four (5%) received extracorporeal membrane oxygenation. Of 14 patients (18%) who died in the ICU, two had no pre-existing comorbidities. The ICU admission rate of patients with pandemic (H1N1) 2009 infection was 22.5/million population. A total of 1882 ICU bed-days (557.5 bed-days/million adult population) were consumed, equating to a 3.9% bed occupancy rate, with a peak of 14.0% in October 2009. Median length of stay was 12 days (IQR, 7-34 days). CONCLUSION: The 2009 influenza A (H1N1) pandemic was a significant burden on Irish ICUs, predominantly affecting the tertiary centres. The demographics and clinical characteristics were similar to those described in the southern hemisphere, suggesting such data may inform future resource planning for similar threats.