Database of butterfly and moth observations in the Netherlands: research from 1947-2020.

Background: The Natural History Museum Rotterdam (NMR) is a regional natural history museum in The Netherlands that focuses on nature and biodiversity of the city of Rotterdam and its surroundings. Bureau Stadsnatuur Rotterdam (bSR) is part of the NMR and collects, mainly on behalf of third parties, data on the flora and fauna from primarily urban areas. The NMR has received a large amount of observation data (1,363 different species in 886,902 observations), in particular of moths and mainly from the Provinces of Zuid-Holland, Noord-Holland and Noord-Brabant from the period 1947-2020. The observation dataset was compiled and standardised from 18 different datasets and stored in a database and published at the Global Biodiversity Information Facility (GBIF). New information: For the first time, a large butterfly and moth observations dataset with historical distribution data for The Netherlands is mobilised and serves as a baseline lepidopteran biodiversity record.

Importance of screening logs in clinical trials for severe traumatic brain injury.

OBJECTIVE: The primary intent for obtaining screening logs in a randomized clinical trial is to assess selection bias in patient recruitment. This is particularly relevant to focused trials in heterogeneous populations such as traumatic brain injury (TBI) patients. We aimed to investigate the benefits of collecting screening logs in two randomized clinical trials conducted in TBI. METHODS: Screening logs were collected as part of the conduct of two multicenter trials of neuroprotective agents in TBI: the Salzburg Atherosclerosis Prevention Program in Subjects at High Individual Risk study (n = 924) and the dexanabinol study (n = 861). Centers were requested to submit monthly information on all patients with TBI admitted to the intensive care unit, including demographics, time of injury and admission, injury severity, and, if not recruited, the reason(s) for exclusion. RESULTS: In the Salzburg Atherosclerosis Prevention Program in Subjects at High Individual Risk study, 52 centers submitted admission data on 4166 patients. In the dexanabinol trial, 96 centers submitted data on 7052 patients. On average, only 20% of patients screened for the Salzburg Atherosclerosis Prevention Program in Subjects at High Individual Risk study and 10% for the dexanabinol trial were enrolled. The main reasons for exclusion were neurological status (29 and 26%, respectively), age (24 and 30%, respectively), and admission outside of the time window (17 and 21%, respectively). Differences in patient characteristics between screened and enrolled patients, with substantial country-specific variation, were observed. CONCLUSION: The collection of screening logs is necessary to report trial results according to the Consolidated Standards of Reporting Trials guidelines and to assess the generalizability of findings. Our experience shows the feasibility of collecting screening logs and illustrates how the potential for selection bias may creep into well-designed randomized clinical trials as a result of factors outside the control of investigators. Consistency and accuracy in screening log completion may further serve as an early indicator of center performance in a trial.

Ethical implications of time frames in a randomized controlled trial in acute severe traumatic brain injury.

OBJECTIVES: To analyze factors determining the time between injury and study drug administration (SDA) in a randomized controlled trial (RCT) of acute severe traumatic brain injury (TBI) and to discuss the ethical implications. METHODS: Time frames prior to SDA, differentiated per country, were analyzed in a recently conducted RCT in severe TBI. Per protocol, the time window for SDA was 6 h after injury. We selected patients for whom written proxy consent (PC) was obtained prior to SDA (n=631). RESULTS: The time between injury and admission to the neurotrauma center (NTC) varied per country from 1.16 to 2.35 h, but CT scan was obtained on average within 1h of admission. The median time between injury and CT scan was within 3 h in all but one country. The broadest time window was observed between CT scan and obtaining required PC (1.71-2.74 h). The median time between injury and PC varied between countries from 3.75 to 5.00 h. After consent had been obtained, almost all patients subsequently received study drug within 1 h. In 85.3% of all cases time between injury and SDA exceeded 4 h, in 60% 5 h. CONCLUSIONS: The requirement of written PC causes a significant delay in SDA in TBI. With deferred consent, the first dose of an investigational drug could potentially be administered directly after completion of the admission CT scan, which reduce the time to SDA by 50%. We argue that randomization under deferred consent is ethically defendable for emergency research in severe TBI. Recommendations for patient protection are proposed.

Organ donations and unused potential donations in traumatic brain injury, subarachnoid haemorrhage and intracerebral haemorrhage.

OBJECTIVE: To obtain insight into the occurrence of brain death and the potential for brain dead and controlled non-heart-beating organ donors (CNHB) in patients with traumatic brain injury (TBI), subarachnoid haemorrhage (SAH) and intracerebral haemorrhage (ICH) in a large neurosurgical serving area (2.1 million inhabitants). DESIGN: Retrospective analysis of data concerning patients with TBI, SAH and ICH who died during the course of ICU treatment during 1999-2003. SETTING: A 16-bed neuro-intensive care unit. PATIENTS: Patients with TBI, SAH or ICH who died during the course of ICU treatment. MEASUREMENTS AND RESULTS: The number of ICU deaths in patients with TBI, SAH and ICH declined from 111 in 1999 to 64 in 2003. In total, 476 deaths occurred. Of these, 177 patients were not included in the analysis. Two hundred ninety-nine (299) ventilated patients had two or more absent brainstem reflexes (ABSR) and a Glasgow Coma Score of 3-4 at the moment of treatment withdrawal and formed the potential for organ donation; 61 of these patients were treated until full brain death. Organs of 57 patients could be harvested. We analysed the reasons that organs were not procured in the 242 remaining patients. The most important reasons were family refusal (32%), medical contraindications (14%), and the treating physician not considering potential organ donation (20%). The missed potential is 162/299 (54%). CONCLUSIONS: The number of actual and potential organ donors is declining, but a considerable number of potential CNHB donors exists. Refusal by relatives is the most important reason for failure to procure organs.