To evaluate the costs, consequences, effectiveness, and safety of ciprofloxacin vs standard antibiotic care in patients with an initial acute exacerbation of chronic bronchitis (AECB) as well as recurrent AECBs over a 1-year period.
A total of 240 patients, 18 years or older with chronic bronchitis, with a history of frequent exacerbations (three or more in the past year) presenting with a type 1 or 2 AECB (two or more of increased dyspnea, increased sputum volume, or sputum purulence).
The assessment included AECB symptoms, antibiotics prescribed, concomitant medications, adverse events, hospitalizations, emergency department visits, outpatient resources such as diagnostic tests, procedures, and patient and caregiver out-of-pocket expenses. Patients completed the Nottingham Health Profile, St. George's Respiratory Questionnaire, and the Health Utilities Index. The parameters were recorded with each AECB and at regular quarterly intervals for 1 year. These variables were compared between the ciprofloxacin-treated group and the usual-care-treated group.
Patients receiving ciprofloxacin experienced a median of two AECBs per patient compared to a median of three AECBs per patient receiving usual care. The mean annualized total number of AECB-symptom days was 42.9+/-2.8 in the ciprofloxacin arm compared to 45.6+/-3.0 days in the usual-care arm (p=0.50). The overall duration of the average AECB was 15.2+/-0.6 days for the ciprofloxacin arm compared to 16.3+/-0.6 days for the usual-care arm. Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care (relative risk=1.20; 95% confidence interval [CI], 0.91 to 1.58; p=0.19). Treatment assignment did not affect the interexacerbation period but a history of severe bronchitis, prolonged chronic bronchitis, and an increased number of AECBs in the past year were associated with shorter exacerbations-free periods. There was a slight, but not statistically significant, improvement in all quality of life measures with ciprofloxacin over usual care. The only factors predictive of hospitalization were duration of chronic bronchitis (odds ratio=4.6; 95% CI, 1.6, 13.0) and severity of chronic bronchitis (odds ratio=4.3; 95% CI, 0.8, 24.6). The incremental cost difference of $578 Canadian in favor of usual care was not significant (95% CI, -$778, $1,932). The cost for the ciprofloxacin arm over the usual care arm was $18,588 Canadian per quality-adjusted life year gained. When the simple base case analysis was expanded to examine the effect of risk stratification, the presence of moderate or severe bronchitis and at least four AECBs in the previous year changed the economic and clinical analysis to one favorable to ciprofloxacin with the ciprofloxacin-treated group having a better clinical outcome at lower cost ("win-win" scenario).
Treatment with ciprofloxacin tended to accelerate the resolution of all AECBs compared to usual care; however, the difference was not statistically significant. Further, usual care was found to be more reflective of best available care rather than usual first-line agents such as amoxicillin, tetracycline, or trimethoprim-sulfamethoxazole as originally expected. Despite the similar antimicrobial activities and broad-spectrum coverage of both ciprofloxacin and usual care, the trends in clinical outcomes and all quality of life measurements favor ciprofloxacin. In patients suffering from an AECB with a history of moderate to severe chronic bronchitis and at least four AECBs in the previous year, ciprofloxacin treatment offered substantial clinical and economic benefits. In these patients, ciprofloxacin may be the preferred first antimicrobial choice.
TThe Syva MicroTrak Chlamydia enzyme immunoassay (EIA; Syva Company, San Jose, Calif.) with cytospin and direct fluorescent-antibody assay (DFA) confirmation was evaluated on 43,630 urogenital specimens over a 1-year period in the Provincial Laboratory in Regina, Saskatchewan, Canada. This was a two-phase study intended to define a testing algorithm for Chlamydia trachomatis that would be both highly accurate and cost-effective in our high-volume (> 3,000 tests per month) laboratory. The prevalence of C. trachomatis infection in our population is moderate (8 to 9%). In phase 1, we tested 6,022 male and female urogenital specimens by EIA. All specimens with optical densities above the cutoff value and those within 30% below the cutoff value were retested by DFA. This was 648 specimens (10.8% of the total). A total of 100% (211 of 211) of the specimens with optical densities equal to or greater than 1.00 absorbance unit (AU) above the cutoff value, 98.2% (175 of 178) of the specimens with optical densities of between 0.500 and 0.999 AU above the cutoff value, and 83% (167 of 201) of the specimens with optical densities within 0.499 AU above the cutoff value were confirmed to be positive. A total of 12% (7 of 58) of the specimens with optical densities within 30% below the cutoff value were positive by DFA. In phase 2, we tested 37,608 specimens (32,495 from females; 5,113 from males) by EIA. Only those specimens with optical densities of between 0.499 AU above and 30% below the cutoff value required confirmation on the basis of data from phase 1 of the study. This was 4.5% of all specimens tested. This decrease in the proportion of specimens requiring confirmation provides a significant cost savings to the laboratory. The testing algorithm gives us a 1-day turnaround time to the final confirmed test results. The MicroTrak EIA performed very well in both phases of the study, with a sensitivity, specificity, positive predictive value, and negative predictive value of 96.1, 99.1, 90.3, and 99.7%, respectively, in phase 2. We suggest that for laboratories that use EIA for Chlamydia testing, a study such as this one will identify an appropriate optical density range for confirmatory testing for samples from that particular population.
The incidence of cardiovascular events remains high in patients with myocardial infarction (MI) despite advances in current therapies. New and better methods for identifying patients at high risk of recurrent cardiovascular (CV) events are needed. This study aimed to analyze the predictive value of an oral glucose tolerance test (OGTT) in patients with acute myocardial infarction without known diabetes mellitus (DM).
The prospective cohort study consisted of 123 men and women aged between 31-80 years who had suffered a previous MI 3-12 months before the examinations. The exclusion criteria were known diabetes mellitus. Patients were followed up over 6.03???1.36 years for CV death, recurrent MI, stroke and unstable angina pectoris. A standard OGTT was performed at baseline.
We aimed to compare angiographic and clinical outcomes after the implantation of everolimus-eluting (EES) and sirolimus-eluting (SES) stents in patients with diabetes.
There are limited data on long-term outcome after EES vs SES implantation in diabetic patients.
We randomized 213 patients with diabetes and coronary artery disease to EES (n?=?108) or SES (n?=?105) implantation. Angiographic follow-up was performed 10 months after the index procedure and all patients were followed clinically for 4 years. The primary endpoint was angiographic in-stent late luminal loss at 10-month follow-up. Secondary endpoints included angiographic restenosis rate, the need for target lesion revascularization (TLR) and major adverse cardiac events (MACE; defined as cardiac death, myocardial infarction, definite stent thrombosis, or TLR) at 4-year follow-up.
At 10-month angiographic follow-up, in-stent late lumen loss was 0.20?±?0.53 mm and 0.11?±?0.49 mm (P?=?0.28), and angiographic restenosis rate was 3.8% and 5.2% (P?=?0.72) in the EES and SES groups, respectively. At 4-year clinical follow-up, MACE had occurred in 22 (20.4%) patients in the EES group and 25 (23.8%) patients in SES group (HR 0.84, 95% CI 0.47-1.49; P?=?0.55), with TLR performed in 6 (5.6%) and 10 (9.5%) patients in the two groups (HR 0.57, 95% CI 0.21-1-58; P?=?0.28).
EES and SES had comparable 10-month angiographic and 4-year clinical outcomes in patients with diabetes mellitus and coronary artery disease.
Most people with multiple sclerosis (PwMS) experience progressively worsening disability over a period of decades, thus further knowledge about the long-term changes in different areas of disability is essential.
The aims of this study were to evaluate changes in disability over ten years in PwMS, and to explore the value of personal and disease-specific factors and depressive symptoms in predicting disability. A further aim was to explore the value of these factors as predictors of mortality.
This study was based on a 10-year follow-up of a population-based study in Stockholm (n=166). Home visits were used to collect data on personal and disease-specific factors, walking ability, manual dexterity, cognitive function, mood, activities of daily living (ADL) and social/lifestyle activities.
The proportion of the study population who had disability in cognition, mood and social/lifestyle activities remained stable, while the proportion with disability in walking, manual dexterity and ADL increased. Disease severity predicted an increase in all studied variables of disability except in depressive symptoms. Older age and depressive symptoms were associated with mortality.
This study illustrates the importance of tailored interventions for PwMS and highlights the need for health-care professionals to consider the psychological aspects of the disease. Furthermore, our results indicate that the Expanded Disability Status Scale was a useful tool for predicting future disability.
A 10-year follow-up of a population-based study of people with multiple sclerosis in Stockholm, Sweden: changes in health-related quality of life and the value of different factors in predicting health-related quality of life.
Health-related quality of life (HRQL) in people with multiple sclerosis (PwMS) is negatively affected compared to that of the general population. Cognitive impairment and depressive symptoms have been shown to predict worse HRQL in a short-term perspective. Considering the progressive nature of MS, it is essential to include the long-term (10 years) perspective of HRQL in PwMS.
The aim of this 10-year follow-up of a population-based sample of PwMS was to explore changes in and the predictive value of personal factors, degree of MS disability, depressive symptoms and cognitive impairment on HRQL.
Data on personal and disease-specific factors, mood, and cognitive function was collected. Data on HRQL was collected, seen as a health profile with the Sickness Impact Profile, as a health index with the EuroQol 5D and as a single global question with the EQ Visual Analog Scale.
HRQL worsened over 10 years according to the health profile (Sickness Impact Profile Total and its physical dimension) and according to the health index. The effect sizes were small. HRQL assessed with the single global question remained unchanged. Depressive symptoms and cognitive impairment predicted worse HRQL.
In a 10-year perspective the HRQL with regard to its physical domain or when seen as a total health profile tends to get worse in PwMS. Yet, HRQL with regard to its psychosocial domain and with regard to PwMS' self-rated health, remains stable. There is a potential for health-care professionals to decrease the impact of modifiable factors on HRQL in PwMS by identifying those with depressive symptoms and/or cognitive impairment and initiating evidence-based treatment as well as meeting the need for environmental facilitators aiming at reducing disability.
13C-urease breath tests have been extensively used in world-wide gastroenterological practice since the 1990s. We have been using them since 2000, but their clinical application in Russia is far from being universal. Moreover, their results are significantly different from those obtained by other methods for determining H. pylori. The authors report original data on the peculiarities of occurrence of this pathogen in its carriers.
Diagnostic approaches to onychomycosis have traditionally been based on a combination of culture and microscopy. In the present study clinical specimens from 346 patients with suspected onychomycosis were analysed by 18S polymerase chain reaction (detection) followed by sequencing and subsequent database search (identification) in parallel with routine culture on agar (detection and identification). In 49 samples Trichophyton rubrum was identified by culture and sequencing. In 67 additional culture negative samples, a positive dermatophyte sequence was obtained (T. rubrum in 54, T. mentagrophytes in 5, and T. species in 8 samples). Fifteen samples cultured positive while no sequence was obtained. Two hundred and seven samples were negative by culture as well as by sequencing. Nails from 10 healthy controls were negative by culture and sequencing. In conclusion, the number of specimens that were positive by polymerase chain reaction was more than double the number that were positive by culture alone.
Results of standard patch tests performed with the same methodology in one centre are rarely available over a large time span. This gives the unique opportunity to study not only prevalence but also persistency of contact allergy and characterize subpopulations. The objectives were to investigate sensitivity rates and persistencies of patch test results and characterize patients with multiple contact allergies. A 20-year retrospective database-based study of 14 998 patients patch tested with the European Standard Series was performed. 34.5% were sensitized, primarily women. Sensitivity to nickel was most frequent and least frequent to mercaptobenzothiazole, N-isopropyl-N-phenyl-p-phenylenediamine and benzocaine. Yearly proportion of negative, mono/double-allergic, and multiple-allergic cases remained stable. Persistency of positive reactions was high for para-phenylenediamine, Cl(Me)isothiazolinone, and primin and poor for paraben mix. 5.1% were multiple allergic, primarily women, and 90% got diagnosed by the first test. Frequency of multiple allergies increased with age. More multiple- than mono/double-allergic patients were tested multiple times. Persistency and sensitivity rates in a Danish eczema population are provided and are useful for decisions regarding the standard series. Patients with multiple contact allergies are typically elderly women who might have long-lasting and hard-to-treat eczema. Cumulative environmental exposure seems necessary to develop multiple allergies.