Prevalence and impact of antidepressant-associated sexual dysfunction in three European countries: replication in a cross-sectional patient survey.

Sexual dysfunction is a common but often unrecognized side effect of many antidepressants. Building upon the results of a previous investigation, this study aimed to assess the prevalence and impact of antidepressant-associated sexual dysfunction (AASD) in three European countries. A cross-sectional survey of 704 adults in Germany, Spain, and The Netherlands was used in the study. All participants had recently started taking a selective serotonin reuptake inhibitor or serotonin- noradrenaline reuptake inhibitor. Information about other medications and conditions known to impair sexual functioning was gathered, and changes in sexual functioning and the impact of such changes were assessed. The SF-12 and Arizona Sexual Experience Scale (ASEX) were administered to measure health status and sexual functioning. AASD was defined using ASEX scores and information regarding changes in sexual functioning. ASEX scores generally exceeded the threshold defining sexual dysfunction: 67.2% in the German, 79.4% in the Spanish, and 73.3% in the Dutch samples. The prevalence of AASD was conservatively estimated to be between 37.1% (German sample) and 61.5% (Spanish sample). Overall, 46.4% of male and 52.1% of female participants were classified with AASD. Patients classified with AASD reported significantly worse quality of life (QoL), self-esteem, mood, and relationships with partners, compared with non-AASD patients. There were significant differences between patients with and without AASD in SF-12 Mental Component scores, with AASD patients displaying poorer mental well-being. Sexual dysfunction is a frequent occurrence during antidepressant treatment, and is associated with reduced QoL and self-esteem, and negative effects on mood and relationships.

The development and psychometric evaluation of the Motivation and Energy Inventory (MEI).

Because depressed patients commonly experience reductions in motivation and energy, both as symptoms of their disorder and as side effects of pharmacotherapy, it is important to identify interventions that can restore their vitality. The Motivation and Energy Inventory (MEI) was recently developed to facilitate the evaluation of such efforts both in depression research, as well as in other therapeutic areas where vitality is an important issue. The constructs addressed by the MEI were identified through a combination of literature review, consultation with experts, and patient focus groups. Potential problems identified during cognitive testing and addressed in subsequent revisions related to the instructions, reference period, response scale sizes, and response scale labels, as well as a number of item-specific issues. Most recently, the data from two randomized, placebo-controlled clinical trials were utilized to evaluate the psychometric properties of the new questionnaire. In general, the data collected during the first and second trial were used for exploratory and confirmatory analysis, respectively. Consistent with the measurement model of the MEI, the psychometric results confirm that the instrument has three factors generally addressing physical energy, mental energy, and social motivation. Furthermore, these results provide evidence for the internal consistency, construct validity, and responsiveness of all three MEI subscales. Additional work is currently underway to examine test-retest reliability and establish minimal clinically important difference values for the MEI subscales.

Birth and first-year costs for mothers and infants attributable to maternal smoking.

Maternal smoking during pregnancy has been linked to high costs. This study estimates the magnitude of excess costs attributable to smoking during pregnancy for mothers and infants. The model estimates smoking-attributable costs for 11 infant and maternal conditions. From a claims database of 7784 mothers and 7901 infants who had deliveries during 1996, we estimated total cost over the infants' first year of life for each mother and infant and identified each complication of interest, based on ICD-9 codes. The average cost for smokers and non-smokers could not be computed directly because smoking status is not available in claims data. Therefore, the population attributable risk percentage (PAR%) due to smoking for each complication was identified from the literature. Multiple linear regression was used to provide estimates of the incremental cost associated with each smoking-related complication. The total cost attributable to smoking was computed as a function of the incremental cost of each complication and the PAR% for each complication. The conditions associated with the largest incremental costs compared to patients without those conditions were abruptio placenta ($23,697) and respiratory distress syndrome ($21,944). Because they were more common, the conditions with the largest smoking-attributable cost were low birth weight ($914) and lower respiratory infection ($428). The sum of the additional costs attributable to smoking for all conditions yielded a total in the first year after birth ranging from $1142 to $1358 per smoking pregnant woman. It was concluded that maternal smoking during pregnancy results in an economic burden to payers and society. These estimates may be useful in formal cost-effectiveness evaluations of individual smoking cessation strategies.

Development of the health and economic consequences of smoking interactive model.

OBJECTIVE: To describe the health and economic consequences of smoking model, a user friendly, web based tool, designed to estimate the health and economic outcomes associated with smoking and the benefits of smoking cessation. RESULTS: An overview of the development of the model equations and user interface is given, and data from the UK are presented as an example of the model outputs. These results show that a typical smoking cessation strategy costs approximately 1200 pounds sterling per life year saved and 22,000 pounds sterling per death averted. CONCLUSIONS: The model successfully captures the complexity required to model smoking behaviour and associated mortality, morbidity, and health care costs. Furthermore, the interface provides the results in a simple and flexible way so as to be useful to a variety of audiences and to simulate a variety of smoking cessation methods.

Assessing a tool to measure patient functional ability after outpatient surgery.

UNLABELLED: The "24-Hour Functional Ability Questionnaire" (24hFAQ) was developed to measure final recovery and satisfaction 24 h after surgery. We used structured interviews preoperatively to measure baseline patient concerns, and up to 24 h after discharge, to assess patient function and satisfaction. The primary objective was to assess the validity of the newly developed 24hFAQ in the postoperative outpatient setting. The criteria assessed were 1) CONTENT: comparison with expert opinion and patients' views and response frequency distributions for asymptotes and irrelevance, 2) Construct: contribution of cognitive, physical, and satisfaction domains to postoperative functional ability, 3) Discrimination: comparing mean clinical end points with patient satisfaction, and 4) Criterion (predictive) validity: testing that related constructs are best correlated. CONTENT validity was supported by the appropriate frequency distribution of subject responses, by the lack of floor or ceiling effects, and by <2% of responses indicating irrelevance. Construct validity was supported by moderate-to-strong positive interitem correlations within the cognitive and physical domains as predicted a priori. Discriminant validity support was mixed: key symptoms were associated with adverse patient satisfaction, but operating room and postanesthesia care unit residence times were unrelated. Criterion validity was supported by the finding that preoperative concern with key symptoms was independent of postoperative outcomes. The validity assessment presented was the first assessment of the measurement capability of the 24hFAQ in an outpatient postoperative population. These results provide overall support for the validity of the 24hFAQ for use in outpatient populations. IMPLICATIONS: This study assessed the validity of a novel functional ability questionnaire that measured functional status after recovery from anesthesia and satisfaction 24 h after outpatient surgery. The content, construct, discriminant, and criterion (predictive) validities demonstrated the utility of this assessment instrument in the outpatient setting.

Evaluation of three theophylline dosing equations for use in infants up to one year of age.

To develop appropriate theophylline dosage recommendations for infants < or = 1 year of age, we evaluated the Nassif, Hendeles, and Hatzopoulos dosing equations in 75 infants who were receiving theophylline intravenously by continuous infusion. Postnatal age ranged from 1 to 52 weeks and postconceptional age from 33 to 93.8 weeks. Using each patient's measured theophylline clearance at steady state and the dose recommended by each of the three equations, we predicted a steady-state serum theophylline concentration for the three equations. The recommended theophylline dose and resultant serum concentrations differed significantly for the three equations. The Nassif, Hendeles, and Hatzopoulos equations resulted in 78.7%, 97.3%, and 93.8%, respectively, of serum theophylline concentrations between 5 and 15 mg/L. The Hendeles and Hatzopoulos equations tended to produce concentrations between 5 and 10 mg/L in the majority of infants; the Nassif equation generally resulted in values between 10 and 20 mg/L. Four percent of the calculated serum concentrations with the Nassif equation were > 20 mg/L. When a desired concentration of 10 mg/L was used in the Hatzopoulos equation, predictions of theophylline concentrations were consistently inflated. We conclude that the Hendeles equation ((0.008 x Postnatal age in weeks) + 0.21 = mg/kg per hour or mg/kg daily = (0.2 x Postnatal age in weeks) + 5) is preferred when intravenous theophylline therapy for apnea and bradycardia or for asthma is initiated. Regardless of the equation used to estimate an initial theophylline dose in infants < or = 1 year of age, serum theophylline concentrations should be monitored within 6 to 12 hours after the start of therapy.

Ability of three pharmacokinetic equations to predict steady-state serum theophylline concentrations in pediatric patients.

The pharmacokinetic equations of Chiou, Koup, and Kurland are often used in the pediatric setting to predict steady-state theophylline clearance using non-steady serum theophylline concentrations. However, these equations have not been validated or compared in a pediatric population. We evaluated the ability of these equations to predict steady-state serum theophylline concentrations in 61 children (0.21-14.3 years) who received a continuous intravenous theophylline (0.79 +/- 0.12 mg/kg/h) infusion for a minimum of five half-lives. Theophylline concentrations used in the Kurland equation were obtained 10.8 +/- 4.5 h after initiation of therapy and the time between the two concentrations used in the Chiou and Koup equations was 9.2 +/- 3.9 h. Predicted steady-state theophylline concentration values for the three methods were not different from each other (p = 0.91), nor were they different from the observed steady-state concentration values (p = 0.92). The coefficient of determination for predicted vs. observed steady-state concentrations was statistically significant (p less than 0.001) and was comparable for the three methods. There was no difference in mean bias (p = 0.78), precision (p = 0.82), or % error (p = 0.86) values for the three methods. Regardless of the method used, 75 to 82% of all predicted theophylline concentrations were within 20% of the observed steady-state value. However, on average, all methods underpredicted the clearance and hence overpredicted the serum theophylline concentration. The Kurland method did not predict steady-state concentrations any better in patients who had received theophylline prior to admission.(ABSTRACT TRUNCATED AT 250 WORDS)