Are the sampling inclusion criteria sampling exclusion criteria or both clearly identified and appropriate for the study?
Are the sampling inclusion criteria sampling exclusion criteria or both clearly identified and app Show more Are the sampling inclusion criteria sampling exclusion criteria or both clearly identified and appropriate for the study? What was the inclusion/exclusion criteria? in the below research paper USING A CRITERIA-BASED REMINDER TO REDUCE USE OF INDWELLING URINARY CATHETERS AND DECREASE URINARY TRACT INFECTIONS By Yin-Yin Chen RN PhD Mei-Man Chi RN MS Yu-Chih Chen RN PhD Yu-Jiun Chan MD PhD Shin-Shang Chou RN PhD and Fu-Der Wang MD 2013 American Association of Critical-Care Nurses doi: http://dx.doi.org/10.4037/ajcc2013464 Background Duration of indwelling urinary catheterization is an important risk factor for urinary tract infection. Objectives To determine whether a reminder approach reduces the use of urinary catheters and the incidence of catheter- associated urinary tract infections. Methods A randomized control trial was performed in 2 res- piratory intensive care units in a 2990-bed tertiary referral medical center. Patients who had urinary catheters in place for more than 2 days from April through November 2008 were randomly assigned to either the intervention group (use of a criteria-based reminder to remove the catheter) or the control group (no reminder). Results A total of 278 patients were recruited. Utilization rate of indwelling urinary catheters was decreased by 22% in the intervention group compared with the control group (relative risk 0.78; 95% CI 0.76-0.80; P < .001). The intervention signifi- cantly shortened the median duration of catheterization (7 days vs 11 days for the control group; P < .001). The success rate for removing the catheters in the intervention group by day 7 was 88%. The reminder intervention reduced the incidence of catheter-associated infections by 48% (relative risk 0.52; 95% CI 0.32-0.86; P = .009) in the intervention group compared with the control group. Conclusions Use of a criteria-based reminder to remove indwelling urinary catheters can diminish the use of urinary catheterization and reduce the likelihood of catheter-associated urinary infections. This reminder approach can prevent catheter-associated urinary infections and its use should be strongly considered as a way to enhance the safety of patients. (American Journal of Critical Care. 2013;22:105-114) rinary tract infections (UTIs) are common hospital-acquired infections and account for up to 40% of the 2 million nosocomial infections reported per year (UTIs are the most common nosocomial infections).1 The incidence is 3.1 to 6.4 catheter-associated urinary tract infections (CAUTIs) per 1000 catheter-days whereas urinary catheters are used in 56% to 89% of adult patients in critical care units.2 Nevertheless 80% of UTIs are due to the presence of indwelling urinary catheters.34 The risk of a UTI increases as the duration of catheterization increases. A patient with an indwelling urinary catheter has a 5% daily risk for development of a UTI.5 Evidence15-9 clearly indicates that early catheter removal can lower the incidence of CAUTIs. The US Centers for Disease Control and Prevention (CDC) strongly recommends placement of indwelling urinary catheters only when indicated and removal of the devices when the indication no longer exists.1011 Nonetheless 41% of physicians do not follow this recommen- dation and clinical nursing staff may also neglect to perform the evaluation necessary to determine whether a catheter should be removed. As a result up to 47% of catheterization days in hospitalized patients are unnecessary.1213 Prevention of UTIs has been a global effort and the CDC recommends use of reminder systems to prevent such infections.1011 However the results of previous studies have been contradictory.14 Some researchers reported that this approach could be effective in decreasing the UTI rate but other inves- tigations found no significant difference in the UTI rate with the approach. Therefore our research hypoth- esis was that use of a catheter reminder system can reduce the duration of urinary catheterization and About the Authors Yin-Yin Chen is a head nurse Department of Infection Control and Department of Nursing Taipei Veterans General Hospital and an associate professor College of Nursing National Yang-Ming University Taipei Taiwan. Mei-Man Chi is a nurse clinician Department of Nursing Taipei Veterans General Hospital. Yu-Chih Chen is direc- tor Department of Nursing Taipei Veterans General Hospital associate professor School of Nursing Taipei Medical University and School of Nursing National Taipei University of Nursing and Health Sciences Taipei Tai- wan. Yu-Jiun Chan is director Division of Infectious Dis- eases Department of Medicine and Division of Clinical Virology Department of Pathology and Laboratory Med- icine Taipei Veterans General Hospital and associate professor Institute of Public Health National Yang-Ming University. Shin-Shang Chou is deputy director Depart- ment of Nursing Taipei Veterans General Hospital and assistant professor School of Nursing Taipei Medical University. Fu-Der Wang is director Department of Infec- tion Control and Division of Infectious Diseases Depart- ment of Medicine Taipei Veterans General Hospital and assistant professor School of Medicine and Institute of Public Health National Yang-Ming University. Corresponding author: Fu-Der Wang MD Taipei Veterans General Hospital Infection Control No. 201 Shi-Pai Sec 2 Taipei 11217 Taiwan ROC (e-mail: fdwang@vghtpe .gov.tw). the incidence of CAUTIs. The purpose of our study was to evaluate the outcomes of the use of the crite- ria-based reminder system on the removal of indwelling catheters. Materials and Methods The study was approved by the appropriate institutional review board before implementation. Patients and Randomization The study was carried out in 2 respiratory inten- sive care units (RICUs) in a 2990-bed tertiary refer- ral medical center in Taiwan. All adult patients admitted to the 2 units were potentially eligible for inclusion in the study if they had an indwelling uri- nary catheter in place at the time of admission or during their stay in the RICUs from April through November 2008. Patients were excluded from the study if they had not had an indwelling urinary catheter or did not stay in the RICU for more than 2 days. Catheters were inserted in the RICU in 231 instances (64%) and outside the unit in 130 instances (36%). Of the instances outside the RICU 40 involved emergency units (11.1%); 37 other hospitals (10.2%); 33 other units of the hospital (9.1%); and 20 nurs- ing homes (5.5%). According to Dumigan et al15 removal of a uri- nary catheter leads to a 10% to 29% decrease in the incidence of UTIs. For a 2-sided = 0.05 at 80% power and 15% effect size the sample size of each group was determined to be at least 130. Figure 1 shows the allocation of the 509 patients from which 278 eligible patients with urinary catheters who had stayed in the RICU for more than 2 days were Assessed for eligibility (N = 509) Excluded (n = 231 ) * did not have an indwelling urinary catheter or stayed in the respiratory intensive care unit < 2 days Randomly assigned (n = 278) Without use of removal crite- ria (control group n = 131) Use removal criteria (intervention group n = 147) Catheter removed 7 days (n = 48) Catheter removed 7 days (n = 83) Catheter removed 7 days (n = 86) nt >7 days dmission o meet oval criteria Without Without Without Without CAUTI CAUTI CAUTI CAUTI CAUTI CAUTI CAUTI CAUTI (n = 5 (n = 43 (n = 29 (n = 54 (n = 3 (n = 83 (n = 17 (n = 44 10.4%) 89.6%) 34.9%) 65.1%) 3.5%) 96.5%) 27.9%) 72.1%) Figure 1 Algorithm describing the assignment of patients in the study. CAUTI catheter-associated urinary tract infection. identified. Computer-generated random numbers were used to assign the patients who were enrolled in the study to either the control group (131 patients for whom a criteria-based reminder was not used) or the intervention group (147 patients for whom a criteria-based reminder was used to prompt removal of the catheter on the seventh day of catheterization). Study Intervention Most of the patients in the study had respira- because the protocol was not followed. A treatment- contamination analysis was carried out on those patients who had an indwelling urinary catheter in place for more than 7 days (see Figure 1). Indications for use (Table 1) and removal (Figure 2) of indwelling urinary catheters were based on the guidelines of the CDC and the Society for Healthcare Epidemiology of America/Infectious Diseases Society of America.1011 Removal was con- tingent on the absence of the following conditions: urinary tract obstruction neuro- tory failure and were being treated with mechanical ventilation. Shapiro et al16 reported that use of indwelling urinary catheters for more than 7 days led to a higher incidence of UTIs with a relative risk (RR) factor of 6.8. Therefore on the seventh day at the latest the patients with catheters in the inter- vention group were evaluated by using the reminder sheet to determine the feasibility of catheter removal. The first analysis was conducted on an intention-to-treat basis and a per-protocol analysis genic bladder dysfunction and uri- nary retention the need to undergo urological procedures or urological surgery or surgery on contiguous structures incontinence in patients with open wounds located in the sacral or perineal regions urine output 500 mL/d or less and signs of renal failure (creatinine level 2.0 mg/dL [to convert to micro- Most of the patients in the study had respira- tory failure and were being treated with mechanical ventilation. was performed for the patients who had indwelling urinary catheters for less than 7 days. Patients whose catheters were removed later than planned were excluded from the per-protocol analysis and were moved to a treatment-contamination group moles per liter multiply by 88.4]). If indications for catheter removal were…
