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Postmarketing Surveillance of Drugs*
Published in Gary M. Matoren, The Clinical Research Process in the Pharmaceutical Industry, 2020
One approach which has gained some popularity is to invite a group of physicians to complete a standard form on a number of patients whom they are treating with a drug of interest. Data on several thousand patients can be accumulated in this way. This approach supplies both numerator and denominator data.
Infectious Disease Data from Surveillance, Outbreak Investigation, and Epidemiological Studies
Published in Leonhard Held, Niel Hens, Philip O’Neill, Jacco Wallinga, Handbook of Infectious Disease Data Analysis, 2019
Denominator data. A key source of non-health data which is important for surveillance is demographic data on population denominators. In many countries this is collected and made available by a national statistics bureau, either derived from a population census or, in some countries, from a population register. Denominator data is crucial to be able to calculate incidence rates and to assess how representative surveillance data is of the general population.
The Public Health Action Plan to Combat Antimicrobial Resistance and the Prevention of Antimicrobial Resistance in Health Care Settings
Published in Robert C. Owens, Paul G. Ambrose, Charles H. Nightingale, Antibiotic Optimization, 2004
Several state health departments have elected to implement enhanced antimicrobial drug-resistance surveillance programs using alternative surveillance methods. Two methods frequently used by states are sentinel (i.e., survey of subset of laboratories) and antibiogram (i.e., cumulative susceptibility data) surveillance. Common difficulties have been identified with implementing sentinel systems. Those difficulties include logistical obstacles with isolate or data processing and communication breakdowns between laboratory, epidemiology, and hospital infection control personnel. Care must be taken in selecting the numbers and types of laboratories to participate in a sentinel network. States collecting antibiograms from hospitals and state laboratories may also face challenges, including incompatible formatting of drug-testing panels, the inconsistent inclusion of duplicate or repeat isolates, and inconsistent reporting of denominator data. Solutions to these problems commonly involve improving communication between clinical microbiology laboratories and state health departments, including laboratory input in decision making and providing feedback of data from the system to participants. Guidance for aggregating cumulative susceptibility data (i.e., antibiograms) has been published and may serve as a guide for states and clinical microbiology laboratories in conducting surveillance (11). Another aspect of surveillance focuses on detecting rare events. Such events may include new changes in susceptibility, new mechanisms of resistance, susceptibility of unusual pathogens, and unexpected sources of resistant organisms. Establishing good communication among personnel in health departments and clinical laboratories is important for improving detection and reporting of such events. Allocating resources for improved surveillance is a practical and responsive step for states interested in tracking local resistant trends. Local data are important for raising public awareness, establishing resources and prevention activities, developing and informing treatment guidelines, monitoring trends, and motivating behavior change among clinicians.
Five-year surveillance and correlation of antibiotic consumption and resistance of Gram-negative bacteria at an intensive care unit in Serbia
Published in Journal of Chemotherapy, 2020
Radmila Popović, Zdenko Tomić, Ana Tomas, Nada Anđelić, Sanja Vicković, Gordana Jovanović, Dragica Bukumirić, Olga Horvat, Ana Sabo
A retrospective, non-interventional, single-centre study was conducted covering the period between 1st January 2014 and 31st December 2018, for the monitoring of AMR and consumption of antibacterials in the ICU in Vojvodina, northern Serbia. It is a department with 12 beds and around 900 yearly admissions for surgical pathologies, in the Clinical centre of Vojvodina, the largest tertiary care university hospital in this part of Serbia. The Ethics Committee of the Clinical Centre of Vojvodina approved the research (Approval no. 6 Broj 00-740). During the period of the study, no changes in usual infection control measures were observed and no antimicrobial stewardship interventions were implemented. Denominator data in the form of number of hospital inpatient-days (bed-days), i.e., the sum of each daily inpatient census every year, were obtained from the hospitals’ administrative records. The daily inpatient census refers to all patients present at the unit as well as any inpatients admitted or discharged before the next census-taking time.
Rates of knee arthroplasty in anterior cruciate ligament reconstructed patients: a longitudinal cohort study of 111,212 procedures over 20 years
Published in Acta Orthopaedica, 2019
Simon G F Abram, Andrew Judge, Tanvir Khan, David J Beard, Andrew J Price
To determine the relative risk of knee arthroplasty after ACL reconstruction in comparison with the general population, the absolute rate of knee arthroplasty in 2016–17 was calculated for patients with and without a history of previous ACL reconstruction (records of ACL injury specifically were not available in this database). For the ACL population, the numerator was the number of matched, same side, knee arthroplasty procedures. For the general population, the numerator was all other knee arthroplasty patients without a history of ACL reconstruction. The denominator for the ACL population was all living patients in 2016–17 without a prior history of knee arthroplasty in the index knee. For the general population, denominator data were extracted from the ONS national population estimates. The relative annual risk (risk ratio) of knee arthroplasty for these respective populations within the most recent years of data (2016–17) was then calculated. To aid interpretation and for clinical relevance, both the absolute and relative risk estimates were stratified according to the age of the patient in 2016–17, irrespective of the year of previous ACL reconstruction, where applicable.
A web-based point prevalence survey of antimicrobial use and quality indicators at Raleigh Fitkin Memorial Hospital in the Kingdom of Eswatini and the implications
Published in Hospital Practice, 2022
Prudence C. Gwebu, Johanna C. Meyer, Natalie Schellack, Zinhle C. Matsebula-Myeni, Brian Godman
The study population included all neonates, pediatric and adult in-patients who were in the ward at 08h30 on the day of the survey. For the purpose of calculating the point prevalence of antimicrobial use, basic data was collected on all patients, and this served as the denominator. The denominator data was the total number of inpatients at 08h30 in the ward surveyed and the total number of beds in the ward surveyed. Detailed data was subsequently collected for only those patients who were on antimicrobial therapy, which served as the numerator. This included patients taking one or more antimicrobials except for topical antimicrobials, as well as any antituberculosis treatments and chronic antiviral treatment.