In the appropriate environment, selective nonoperative management of penetrating abdominal solid organ injuries has a high success rate and a low complication rate.
SummaryBackgroundSince the 1918 influenza pandemic, non-randomised studies and small clinical trials have suggested that convalescent plasma or anti-influenza hyperimmune intravenous immunoglobulin (hIVIG) might have clinical benefit for patients with influenza infection, but definitive data do not exist. We aimed to evaluate the safety and efficacy of hIVIG in a randomised controlled trial.MethodsThis randomised, double-blind, placebo-controlled trial was planned for 45 hospitals in Argentina, Australia, Denmark, Greece, Mexico, Spain, Thailand, UK, and the USA over five influenza seasons from 2013–14 to 2017–18. Adults (≥18 years of age) were admitted for hospital treatment with laboratory-confirmed influenza A or B infection and were randomly assigned (1:1) to receive standard care plus either a single 500-mL infusion of high-titre hIVIG (0·25 g/kg bodyweight, 24·75 g maximum; hIVIG group) or saline placebo (placebo group). Eligible patients had a National Early Warning score of 2 points or greater at the time of screening and their symptoms began no more than 7 days before randomisation. Pregnant and breastfeeding women were excluded, as well as any patients for whom the treatment would present a health risk. Separate randomisation schedules were generated for each participating clinical site using permuted block randomisation. Treatment assignments were obtained using a web-based application by the site pharmacist who then masked the solution for infusion. Patients and investigators were masked to study treatment. The primary endpoint was a six-category ordinal outcome of clinical status at day 7, ranging in severity from death to resumption of normal activities after discharge. The choice of day 7 was based on haemagglutination inhibition titres from a pilot study. It was analysed with a proportional odds model, using all six categories to estimate a common odds ratio (OR). An OR greater than 1 indicated that, for a given category, patients in the hIVIG group were more likely to be in a better category than those in the placebo group. Prespecified primary analyses for safety and efficacy were based on patients who received an infusion and for whom eligibility could be confirmed. This trial is registered with ClinicalTrials.gov, NCT02287467.Findings313 patients were enrolled in 34 sites between Dec 11, 2014, and May 28, 2018. We also used data from 16 patients enrolled at seven of the 34 sites during the pilot study between Jan 15, 2014, and April 10, 2014. 168 patients were randomly assigned to the hIVIG group and 161 to the placebo group. 21 patients were excluded (12 from the hIVIG group and 9 from the placebo group) because they did not receive an infusion or their eligibility could not be confirmed. Thus, 308 were included in the primary analysis. hIVIG treatment produced a robust rise in haemagglutination inhibition titres against influenza A and smaller rises in influenza B titres. Based on the proportional odds model, the OR on day 7 was 1·25 (95% CI 0·79–1·97; p=0·33). In subgroup analyses for the pr...
Saturation of data has been acknowledged by many social scientists as evidence of rigor in qualitative research. Though there is a consensus about its definition and usefulness in qualitative research, the methods for achieving saturation are scarce while the social scientists who mention data saturation in their research methodologies do not adequately describe how this is achieved. This paper describes a new method for achieving saturation in studies that use interviews. The method is called Comparative Method for Themes Saturation (CoMeTS). CoMeTS is comparative in two ways. First, all themes from all interviews are compared with each other. Second, the sequence of interviews is reordered multiple times in order to check saturation again. This is because the sequence of interviews during the check makes saturation vary and, therefore, reordering helps confirming saturation. This paper concludes that CoMeTS is a simple, comparative and holistic method for achieving saturation and that it can be used in complicated qualitative studies.
Background: The aim of this review is to identify the roles and activities of nurses working with people with diabetes and to examine the facilitators and barriers in caring for such people. Methods: A systematic review was conducted. From 531 abstracts reviewed, 29 studies were included (18 studies comprised questionnaire surveys, one was an intervention study, two used both questionnaires and interviews, and eight of them used interviews). Barriers and facilitators were extracted and combined using qualitative synthesis. Results: The literature review revealed three major roles and a number of barriers. A model for achieving enhanced nursing care of patients with diabetes has been developed according to the findings of this literature. Specifically, a stepladder suggesting that through better nursing training and education and by providing adequate resources, time, and synergies to diabetes specialists, nurses will be able to correctly perform their diabetes care roles, which include patient education, advanced care, and psychological support. Conclusions: Taking into serious consideration that a large number of hospital users are people with diabetes and that there is an inconsistency among countries about the work settings of Diabetes Specialist Nurses (DSNs), it is important to give greater focus to inpatient care and perhaps to enhance nurses’ roles by eliminating any barriers that prevent them from providing adequate quality care. Furthermore, integrated care involving the role of DSNs within the inpatient care would have been more beneficial for patients.
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