Purpose
This review aims to describe the sampling methodology used in studies assessing effectiveness of risk minimisation measures (RMMs) in the European Union.
Methods
The European Union electronic Register of Post‐Authorization Studies (EU PAS Register) was searched to identify studies that assessed the effectiveness of RMMs and recruited a target population of healthcare professionals (HCPs), sites or patients. Studies with both protocol and report were included and data was extracted from these documents to describe study characteristics and variables involved in the sampling methodology.
Results
Out of 1092 studies finalised between June 2017 and May 2019, 17 studies were eligible for review. Thirteen were surveys, three chart reviews and one combined both methodologies. All the 17 studies recruited HCPs/sites and 8 of them also recruited patients. The most common rationale for country sampling was market uptake (10/17), while for HCP/site sampling, it was representativeness of the prescribing practices (14/17). Only a minority of the studies (4/17) provided supporting evidence to inform this theoretical framework. HCP/site sampling frames were mainly network of physicians (5/17) or HCP databases (5/17), with only one study providing a detailed description of the sampling frame. HCPs were selected mainly using probabilistic sampling (10/17) and patients using non‐probabilistic sampling (6/8). Only a few studies compared participating with non‐participating HCPs/sites (5/17) and patients (3/8). Eight studies reported that their results were generalisable.
Conclusions
Overall, the study documents provided insufficient details to understand the rationale behind the sampling decisions. More standardisation and guidance in reporting the sampling strategy and operational considerations applicable to these types of studies would support transparency and facilitate the evaluation of representativeness of the study results.
Urinary Tract Infections (UTI) is a major threat to human health. It is caused due to various physiological changes of the urinary tract by the activity of microorganisms. Urinary Tract infections has also been a major type of hospital acquired infection. Hospital acquired infections (HAI) are of various types: Respiratory Tract Infection (RTI), Urinary Tract Infection (UTI), Blood Stream Infection (BSI), and Surgical Site Infection (SSI) and the most common are Urinary Tract (39%) and Respiratory Tract (20-22%) infection. The main aim of this study was to assess various urine samples collected from patients of the ICU of a tertiary care hospital for microbial growth and create a statistical picture on the contribution of UTI to nosocomial infections. Certain governing factors for UTI like presence of pus cells, epithelial cells, and diabetes mellitus were also kept under consideration along with various patient details like age, sex, primary illness and prior antibiotic treatment. The key findings of the study were: the mean age of patients with symptomatic and asymptomatic UTI was 51 years and people from both genders within the age group of 41-60 were equally susceptible. E. coli was the most common causative organism (35.7%) followed by Citrobacter (21.42%) and Klebsiella (14.28%). Other organisms included Pseudomonas, Enterococcus and Candida. The rate of UTI was 56.22/1000 days of catheterization. Most of the organisms isolated were found to be multi drug resistant. UTI has been hence concluded to play a major contribution in nosocomial infections which needs to be controlled by integrating proper monitoring of hospital data and surveillance of hospital acquired urinary tract infection.
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