Prospective Interventional Cohort Study Research Articles

10th Annual Congress of the German Association of Clinical Pharmacology

10th Annual Congress of the German Association of Clinical Pharmacology

Assessment of a pharmaceutical interventional programme in patients on medications with renal risk

ObjectiveTo compare the adaptation of medical prescriptions according to the dosage guides in patients with renal disease, before and after applying a pharmaceutical intervention programme. The secondary objectives were to prepare a guide to dosing in renal disease and to measure the prevalence of prescription of drugs with renal risk. MethodNon-randomised, experimental interventional study (before/after) conducted in a general hospital with 800 beds, including hospitalised patients, over the age of 18, with kidney disease and drugs with renal risk prescribed in their pharmaco-therapeutic profile. The study was designed to be carried out in 2 descriptive cross-cutting phases (control group) and a prospective interventional cohort study (intervention group). The primary variable was the percentage non-adaptation according to the stage of renal disease. ResultsThe study included 185 patients, 88 in the control group and 97 in the intervention group. In the intervention group, the prevalence of non-compliance before and after the intervention was 18.7% and 2.1%, representing a statistically significant reduction in nonadaptation of the dose. The costs saved with the pharmaceutical intervention programme were 1939.63 euro over 2 months, the average saving per medication intervened amounting to 62.57 euro (95% CI, 23.99–101.14 euro; P=.02). ConclusionsThe results of the study indicate that the application of a pharmaceutical care model based on the prospective validation of drugs with renal risk, very significantly improved the adaptation of dosing regimens in kidney disease.

Conscious sedation in the critically ill ventilated patient

Purpose The aim of sedation is to provide comfort and minimize anxiety. However, adverse effects are noteworthy, and the optimal end point of sedation in intensive care unit patients is still debated. We analyzed if a level 2 on the Ramsay Scale (ie, awake, cooperative, oriented, tranquil patient) is suitable for an invasive therapeutic approach. Materials and Methods Forty-two patients requiring respiratory support and sedation for at least 4 days were enrolled in a prospective interventional cohort study aiming at maintaining patients awake and collaborative. The Ramsay score was recorded 3 times a day. Once a day, the nurse in charge evaluated adequacy of sedation according to the compliance with nursing care and therapeutic maneuvers in the previous 24 hours. Data were collected until patients were ventilated. Results Overall, 264 of 582 days were classified as conscious. Sedation was adequate in 93.9% of them. In conscious days, a higher Simplified Acute Physiology Score II score and male sex significantly correlated with inadequate sedation. Conclusions In a population of severe intensive care unit patients, conscious sedation was achieved in almost half of the days spent on ventilation. The positive implications (eg, on length of weaning and cost of sedation) of a conservative sedation strategy may be highly relevant.

Oligoanalgesia in the Emergency Department: Short-Term Beneficial Effects of an Education Program on Acute Pain

Acute pain is the most frequent complaint in emergency department (ED) admissions, but its management is often neglected, placing patients at risk of oligoanalgesia. We evaluate the effect of the implementation of guidelines for pain management in ED patients with pain at admission or anytime during their stay in our ED. This prospective pre-post intervention cohort study included data collection both before and after guideline implementation. Consecutive adult patients admitted with acute pain from any cause or with pain at any time after admission were enrolled. The quality of pain management was evaluated according to information in the ED medical records by using a standardized collection form, and its impact on patients was recorded with a questionnaire at discharge. Two hundred forty-nine and 192 patients were included during pre- and postintervention periods. Pain was documented in 61% and 76% of nurse and physician notes, respectively, versus 78% and 85% after the intervention (difference 17%/9%; 95% confidence interval [CI] 8% to 26%/2% to 17%, respectively). Administration of analgesia increased from 40% to 63% (difference 23%; 95% CI 13% to 32%) and of morphine from 10% to 27% (difference 17%; 95% CI 10% to 24%). Mean doses of intravenous morphine increased from 2.4 mg (95% CI 1.9 to 2.9 mg) to 4.6 mg (95% CI 3.9 to 5.3 mg); administration of nonsteroidal antiinflammatory drugs and acetaminophen increased as well. There was a greater reduction of visual analogue scale score after intervention: 2.1 cm (95% CI 1.7 to 2.4 cm) versus 2.9 cm (95% CI 2.5 to 3.3 cm), which was associated with improved patient satisfaction. Education program and guidelines implementation for pain management lead to improved pain management, analgesia, and patient satisfaction in the ED.

Adrenal insufficiency in severe West Nile Virus infection

To explore adrenal function in severe West Nile virus (WNV) infection. Prospective interventional cohort study in a medical ICU of a teaching hospital. Ten consecutive patients (seven men, mean age 64+/-12years, mean SAPS II 26+/-6) with definite diagnosis of WNV related meningoencephalitis and variable proportion of organ/system failure. All patients had fever (mean body temperature 39+/-1 degrees C) and altered mental status (mean Glasgow Coma Score 11+/-2). Mean SOFA score was 9+/-2; eight patients had systemic inflammatory response syndrome, five septic shock, and six acute respiratory failure (usually from central origin) requiring mechanical ventilation. A short corticotropin test was performed in each patient to assess the adrenal function. Cortisol response was defined as the difference between baseline and corticotropin-stimulated peak. Absolute adrenal insufficiency was defined by a baseline cortisol level below 15 microg/dl (415 nmol/l). Relative insufficiency was defined by a cortisol response of 9 microg/dl (250 nmol/l) or less. Relative adrenal insufficiency, defined by a corticotropin response below 9 microg/dl, was observed in seven while the remaining three had normal cortisol response; six out of these seven died in the ICU. All patients with normal adrenal function survived. Adrenal insufficiency is frequent in severe WNV infection and carries a poor outcome. In the absence of specific effective treatment, our data provide a rational to investigate a supplemental corticosteroid treatment in a controlled trial.

Control of a methicillin-resistant Staphylococcus aureus (MRSA) outbreak in a day-care institution

This article describes an outbreak of methicillin-resistant Staphylococcus aureus (MRSA) in two institutions for multi-handicapped children in Copenhagen. The aim of the study was to determine whether it was possible to eradicate MRSA in a setting with multi-handicapped children and staff where there was a high degree of physical interaction. This was a prospective interventional uncontrolled cohort study that took place from January 2003 to March 2005. All individuals in close contact with the two institutions and/or in close contact with an MRSA-colonized subject from the outbreak were included in the study: 38 children, 60 staff members and 12 close relatives of colonized subjects. Infection control measures included screening all individuals. When MRSA infection or colonization was found, an attempt was made to eradicate MRSA, staff education was undertaken and attempts were made to determine the route of transmission. Eleven individuals were found to be positive for MRSA (10.0%). All isolates were identical by pulsed-field gel electrophoresis and harboured the staphylococcal cassette chromosome mec (SCCmec) type IV. All colonized and infected individuals were associated with a single room in one of the institutions. MRSA was eradicated from all the colonized and infected subjects. This study shows that it is possible to control an MRSA outbreak in institutions for multi-handicapped children where there is a high degree of physical contact.

Pantoprazole for sleepiness associated with acid reflux and obstructive sleep disordered breathing.

To determine the effectiveness of Pantoprazole (Wyeth Pharmaceuticals Inc., Philadelphia, PA) therapy for daytime sleepiness in patients with symptoms of acid reflux and obstructive sleep-disordered breathing (OSDB). Prospective interventional cohort study. Twenty-seven adult subjects (67% men) with symptoms of acid reflux disease and mild to moderate OSDB were included in a 3-month study of proton pump inhibitor therapy (Pantoprazole 40 mg once daily). Primary outcomes included changes in daytime sleepiness, reflux symptoms, and bed partner assessment of snoring. Secondary outcomes included changes in snoring quantification, apnea, and apnea-hypopnea indices (AHI) with SNAP Laboratories (Glenview, IL) home sleep study and self-reported global symptom improvement. At baseline, patients were typically middle-aged, obese men with mild to moderate sleep apnea (mean AHI = 15) with excessive daytime somnolence (mean Epworth Sleepiness Score = 13). After 3-month treatment with Pantoprazole, a statistically significant improvement was noted for daytime sleepiness (P = .002) and total reflux symptoms (P = .0006). Subjects also reported a significant reduction in reflux awakening them from sleep (P < .0001). Bed-partner assessment of snoring significantly improved (P = .03); however, no significant improvements were noted in snoring quantification, apnea, or AHI. When compared with a disease-severity matched historic placebo-control group, this cohort demonstrated a significantly greater reduction in daytime sleepiness (P = .04). This cohort of subjects had significant improvements in daytime sleepiness and reflux symptoms, including reflux awakening from sleep, with Pantoprazole therapy. Further controlled studies are indicated to confirm these results. Improvement in daytime somnolence likely resulted from a reduction in reflux-related arousals because no improvements occurred in OSDB.

Keratocyte density of central human cornea after laser in situ keratomileusis

PURPOSE: To determine changes in keratocyte density in the first year after laser in situ keratomileusis (LASIK). DESIGN: Prospective interventional cohort study. METHODS: Seventeen eyes of 11 patients received LASIK with a planned 180-μm flap to correct refractive errors between −2.0 diopters and −11.0 diopters. Images of the full-thickness cornea were obtained by using confocal microscopy in vivo before LASIK and at 1 week, 1, 3, 6, and 12 months after LASIK. Bright objects (that resembled keratocytes) in images without motion blur were manually counted by one observer. Cell densities were determined in anterior and posterior halves of the stromal flap, anterior and posterior halves of the layer 100 μm-thick immediately deep to the ablation (retroablation layer), and in the posterior third of the stroma. The region of stroma that was ablated (as measured 1 month after LASIK) was omitted from the preoperative analysis. RESULTS: Keratocyte density in the anterior flap was 28,978 ± 5849 cells/mm 3 (mean ± SD) pre-LASIK, and was decreased at all postoperative examinations, but the difference was not significant until 12 months after LASIK (22% decrease). Keratocyte densities in the posterior flap were 20,397 ± 4215 cells/mm 3 pre-LASIK and were decreased by 20%–40% at all postoperative examinations 1 week to 1 year after LASIK. Keratocyte densities in the anterior half of the retroablation layer were 16,605 ± 3595 cells/mm 3 pre-LASIK and decreased by 16%–30% between 3 and 12 months after LASIK. Keratocyte densities in the posterior half of the retroablation layer and posterior stroma did not change. CONCLUSIONS: Keratocyte densities in the posterior flap and anterior retroablation layer (regions adjacent to the lamellar cut) decrease at 1 week and 3 months, respectively, after LASIK and remain decreased in these regions at 12 months after LASIK. In the anterior flap, keratocyte density decreases 1 year after LASIK. The long-term effects of these cellular deficits, if any, require further study.

Tuberculosis Exposure an d Control in an Urban Emergency Department

Study Objective: To measure tuberculosis (TB) conversion rates among staff of an urban emergency department compared with other hospital employees (OHEs) and to evaluate the effectiveness of new TB control measures. Methods: A prospective interventional cohort study was performed in an academic adult 1,000-bed urban hospital, with more than 6,000 employees, and an annual ED census of 43,000. As part of a hospital-wide program, all employees were screened for tuberculin reactivity (Siebert purified protein derivative [PPD] of tuberculin) annually during a 3 1/2-year period. Additional information collected on each employee included country of birth, ethnicity, history of bacille Calmette-Gúerin (BCG) vaccination, length and site of employment, and age. At the end of the second year, TB control measures including construction of a new ED facility with TB respiratory isolation rooms, nonrecirculated air, and droplet shields for registrars were implemented. Relative risk (RR) and 95% confidence intervals (CIs) were calculated. Results: During the first screening cycle, PPD status was obtained on 5,697 hospital employees, 88 of whom worked primarily in the ED. Baseline status was 81% PPD – (induration <5 mm), 9% PPD + (induration ≥10 mm), and 10% refused skin testing. ED staff did not differ from OHEs with regard to PPD status, age, ethnicity, BCG history, foreign birth, residing in a county with high TB prevalence, or length of employment. During the second cycle, 6 of 50 (12%) previously PPD – ED staff and 51 of 2,514 (2%) previously PPD – OHEs converted to PPD + status (RR=5.9; 95% CI 2.7,13.1). After implementing TB control measures, the conversion rate during the third year dropped to 0 for ED staff, whereas the OHEs had a conversion rate of 1.2% during that cycle. Conclusion: TB conversion rates were 5.9 times greater in ED staff members than OHEs before engineering controls were implemented. The ED TB conversion rate fell dramatically in the year following new TB controls. Many EDs are high-risk sites for TB exposure and may benefit from similar measures. [Behrman AJ, Shofer FS: Tuberculosis exposure and control in an urban emergency department. Ann Emerg Med March 1998;31:370-375.]