Study goal: This study was carried out to answer the following research question: which motivation do healthy volunteers have to participate in phase I clinical trials? - Methods: A literature search was done through Google Scholar and Academic Search Premier, followed by three interviews with volunteers who had recently concluded their participation in a (non-commercial) phase I trial. - Results: Our literature search revealed mainly commercial motives for volunteers to participate in phase I clinical trials. The interviews (with volunteers in a non-commercial trial) showed that other factors may also play a decisive role, such as: (1) wish to support the investigator (2) wish to contribute to science, (3) access to more/better health care (4) sociability: possibility to relax and to communicate with other participants (5) general curiosity. Precondition is that risks and burden are deemed acceptable. - Conclusions: financial remuneration appears to be the predominant motive to participate voluntarily in a clinical trial. Other reasons were also mentioned however, such as general curiosity, the drive to contribute to science and the willingness to help the investigator. In addition, social reasons were given such as possibility to relax and to meet other people. Potential subjects state that they adequately assess the (safety) risks of participating in a trial as part of their decision process.
Background: The increasing numbers of surgeries involving high risk, multi-morbid patients, coupled with inconsistencies in the practice of perioperative surgical wound care, increases patients’ risk of surgical site infection and other wound complications. Objectives: To synthesise and evaluate the recommendations for nursing practice and research from published systematic reviews in the Cochrane Library on nurse-led pre-operative prophylaxis and post-operative surgical wound care interventions used or initiated by nurses. Design: Meta-review, guided by the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Data sources: The Cochrane Library database. Review methods: All Cochrane Systematic Reviews were eligible. Two reviewers independently selected the reviews and extracted data. One reviewer appraised the methodological quality of the included reviews using A MeaSurement Tool to Assess Systematic Reviews 2 (AMSTAR 2) checklist. A second reviewer independently verified these appraisals. The review protocol was registered with the Prospective Register of Systematic Reviews. Results: Twenty-two Cochrane reviews met the inclusion criteria. Of these, 11 reviews focused on pre-operative interventions to prevent infection, while 12 focused on post-operative interventions (one review assessed both pre-and post-operative interventions). Across all reviews, 14 (63.6%) made at least one recommendation to undertake a specific practice, while two reviews (9.1%) made at least one specific recommendation not to undertake a practice. In relation to recommendations for further research, insufficient sample size was the most predominant methodological issue (12/22) identified across reviews. Conclusions: The limited number of recommendations for pre- and post-operative interventions reflects the paucity of high-quality evidence, suggesting a need for rigorous trials to address these evidence gaps in fundamentals of nursing care.
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BACKGROUND: The SpO2/FiO2 is a useful oxygenation parameter with prognostic capacity in patients with ARDS. We investigated the prognostic capacity of SpO2/FiO2 for mortality in patients with ARDS due to COVID-19.METHODS: This was a post-hoc analysis of a national multicenter cohort study in invasively ventilated patients with ARDS due to COVID-19. The primary endpoint was 28-day mortality.RESULTS: In 869 invasively ventilated patients, 28-day mortality was 30.1%. The SpO2/FiO2 on day 1 had no prognostic value. The SpO2/FiO2 on day 2 and day 3 had prognostic capacity for death, with the best cut-offs being 179 and 199, respectively. Both SpO2/FiO2 on day 2 (OR, 0.66 [95%-CI 0.46-0.96]) and on day 3 (OR, 0.70 [95%-CI 0.51-0.96]) were associated with 28-day mortality in a model corrected for age, pH, lactate levels and kidney dysfunction (AUROC 0.78 [0.76-0.79]). The measured PaO2/FiO2 and the PaO2/FiO2 calculated from SpO2/FiO2 were strongly correlated (Spearman's r = 0.79).CONCLUSIONS: In this cohort of patients with ARDS due to COVID-19, the SpO2/FiO2 on day 2 and day 3 are independently associated with and have prognostic capacity for 28-day mortality. The SpO2/FiO2 is a useful metric for risk stratification in invasively ventilated COVID-19 patients.
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