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Joseph C Cappelleri

Publications and source records attributed to Joseph C Cappelleri.

15 recordsLinked to original sources
PubMed2006

Perioperative myocardial ischemic injury in high-risk vascular surgery patients: incidence and clinical significance in a prospective clinical trial.

OBJECTIVE: The purpose of this study was to assess prospectively the incidence, health care resource utilization, and economic burden associated with perioperative myocardial ischemic injury (PMII) in high-risk patients undergoing noncardiac vascular surgery. METHODS: Two hundred thirty-six patients consented to participate in a pharmacoeconomic substudy as part of a randomized, multicenter clinical trial. Patients were assessed for myocardial ischemic injury by using clinical, biochemical, and electrocardiographic criteria. PMII was defined as fatal or nonfatal myocardial infarction, new or worsened congestive heart failure, or new arrhythmias. Resource utilization parameters were compared for patients with and without PMII. Patients underwent the following index procedures: open abdominal aortic aneurysm repair (n = 44), bypass for aortoiliac disease (n = 29), bypass for femoropopliteal disease (n = 62), bypass for femorotibial disease (n = 71), extra-anatomic bypass (n = 23), and miscellaneous (n = 7). Patients undergoing carotid endarterectomy or only endovascular interventions were excluded. The incremental cost of PMII was estimated by applying the average costs (adjusted to 2004 US dollars) of the hospital ward (dollar 700.00/d) or intensive care unit (dollar 2500.00/d) to the length of stay differences for patients with and without PMII. RESULTS: The overall mortality was 3.4% (8/236), and 7 of 8 deaths were related to PMII. PMII occurred in 42 (17.8%) of 236 patients: 22 myocardial infarctions, 11 congestive heart failures, and 12 new arrhythmias (3 patients had 2 PMII events). There was no evidence of differences in the incidence of PMII among the various index procedures. PMII was associated with a dramatic increase in resource utilization. The mean length of stay was 16.8 and 10.0 days for patients with and without PMII, respectively (P < .001). Intensive care unit care was required by 35 (83.3%) of 42 patients with and 121 (62.4%) of 194 patients without PMII (P < .009). The mean intensive care unit length of stay was 6.6 and 3.7 days for patients with and without PMII, respectively (P < .009). Ten (23.8%) of 42 patients with and 20 (10.3%) of 194 patients without PMII returned to the emergency department for care after discharge (P < .02). CONCLUSIONS: In modern vascular surgery practice, PMII remains common despite the availability of beta-blockers and other preventative strategies. PMII is associated with dramatic increases in resource utilization and cost. The increase in resource utilization associated with PMII resulted in an estimated incremental cost per patient of dollar 9980.00. If 250,000 high-risk open vascular operations are performed annually in the United States, the economic burden of PMII in these procedures alone approximates dollar 444 million. Strategies to decrease PMII incidence and severity should be evaluated in large-scale prospective trials.

Aged↗
PubMed2006

Self-esteem, confidence and relationship satisfaction of men with erectile dysfunction treated with sildenafil citrate: a multicenter, randomized, parallel group, double-blind, placebo controlled study in the United States.

PURPOSE: We assessed the change in confidence, relationships and self-esteem, and its correlation with erectile function in men with ED treated with sildenafil citrate in the first United States based, double-blind, placebo controlled, randomized trial assessed by the validated SEAR. MATERIALS AND METHODS: This 12-week flexible dose (25, 50 or 100 mg) trial determined change scores from baseline to end of treatment for the 5 SEAR components (Sexual Relationship domain, Confidence domain, Self-Esteem subscale [prespecified as the primary end point], Overall Relationship subscale and Overall score), and their correlations with the IIEF and event log data, as well as correlations between SEAR components and a general efficacy question at the end of treatment. RESULTS: Compared with the placebo group (125 patients, mean age +/- SD 55 +/- 13 years, mean years ED 3.8 +/- 4.2), the sildenafil group (128 patients, mean age +/- SD 56 +/- 12, mean years ED 4.6 +/- 4.3) had significantly greater improvements in all 5 SEAR components (p < 0.0001) and all sexual function measures. SEAR component scores showed significant correlations with IIEF Erectile Function domain scores (r range 0.34 to 0.69, p < 0.0001), other IIEF domain scores (p < 0.0001), percentage of successful intercourse attempts (p < 0.0001) and frequency of erection that allowed satisfactory intercourse (p < 0.0001). CONCLUSIONS: In this study of men with ED, sildenafil produced substantial improvements in self-esteem, confidence and relationship satisfaction as measured by SEAR scores, which showed moderate to high positive correlations with IIEF scores.

Adult↗
PubMed2006

Comparison between sildenafil-treated subjects with erectile dysfunction and control subjects on the Self-Esteem And Relationship questionnaire.

INTRODUCTION: Erectile dysfunction (ED) can negatively impact psychosocial measures of a patient's sexual life. AIM: To evaluate self-esteem, confidence, and relationships in men with ED, before and after treatment with sildenafil citrate (Viagra), with reference to controls without ED. METHODS: Sildenafil-naïve patients with ED were enrolled in a 10-week, open-label, flexible-dose (25 mg, 50 mg, or 100 mg) trial of sildenafil. In a separate study, men without ED who did not take sildenafil also completed the Self-Esteem And Relationship (SEAR) questionnaire. In addition to traditional statistical testing, equivalency testing was applied to compare the ED group, before and after treatment, with the control group and to examine whether the ED group improved to normative ranges on the SEAR questionnaire after treatment (within half a standard deviation of the normative or control group mean). MAIN OUTCOME MEASURES: Baseline and end-of-treatment responses on psychosocial aspects of ED were measured with the validated SEAR. RESULTS: Mean SEAR scores between subjects with ED (N = 93, mean age 55.0 years) at baseline and control subjects without ED (N = 94, mean age 52.5 years) were statistically different from zero and not statistically equivalent. Conversely, mean SEAR scores between ED subjects after treatment and control subjects were statistically equivalent and not statistically different from zero. CONCLUSIONS: The results indicate that sildenafil is associated with normalization of relationships, confidence, and self-esteem in men with ED.

Aged↗
PubMed2006

Sildenafil citrate improves self-esteem, confidence, and relationships in men with erectile dysfunction: Results from an international, multi-center, double-blind, placebo-controlled trial.

INTRODUCTION: Erectile dysfunction (ED) can significantly impact a man's relationships and well-being. AIM: We assessed changes in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction in men with ED using the validated Self-Esteem And Relationship questionnaire (SEAR). METHODS: This was a 12-week, double-blind, placebo-controlled, flexible-dose (25, 50, 100 mg, as needed) international study of sildenafil in men > or =18 years of age in Mexico, Brazil, Australia, and Japan. MAIN OUTCOME MEASURES: The primary study outcome was change in self-esteem from baseline to the end of treatment. Secondary study measures were changes in other SEAR components, International Index of Erectile Function (IIEF) domains, percentage of intercourse attempts that were successful, and the response to a global efficacy question at the end of treatment. RESULTS: Patients were well balanced for age and duration of ED (placebo = 149 and sildenafil = 151). Compared with placebo, sildenafil significantly improved self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction (P < 0.0001). The psychosocial measures of well-being assessed with the SEAR were positively correlated (range 0.60-0.86, P < 0.0001) with erectile function, the frequency of achieving erections that allowed satisfactory sexual intercourse, the percentage of successful sexual intercourse attempts, and global treatment efficacy. CONCLUSIONS: Significant improvements in self-esteem, confidence, sexual relationship satisfaction, and overall relationship satisfaction after treatment of ED with sildenafil were consistent among countries. These data suggest a substantial cross-cultural improvement in well-being after successful treatment of ED with sildenafil.

Adult↗
PubMed2005

Revealing the multidimensional framework of the Minnesota nicotine withdrawal scale.

OBJECTIVES: The version of the Minnesota Nicotine Withdrawal Scale (MNWS) under consideration consists of nine items. No psychometric analyses of this version have been published. The objectives of this investigation were to perform a factor analysis and to further assess the psychometric properties of the MNWS. RESEARCH DESIGN AND METHODS: Data came from three Phase II clinical trials on varenicline, developed for smoking cessation, in a sample of smokers. Exploratory factor analysis was used to examine the structure of the MNWS in the first completed study (n = 626) over various time periods. The postulated factor structure was then tested in a set of confirmatory analyses conducted on two subsequent studies (n = 627, n = 312). The proposed structure was further evaluated through construct validity and reliability analyses. MAIN OUTCOME MEASURES: The nine items of the MNWS included the following: urge to smoke (craving); depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating; restlessness; increased appetite; difficulty going to sleep; and difficulty staying asleep. Each item was rated by a subject on an ordinal scale from 0 (not at all) to 4 (extreme). RESULTS: Scree plots and rotated factor patterns from the exploratory factor analyses revealed two multi-item domains--Negative Affect with four items and Insomnia with two items--and three individual items (Craving, Restlessness, Increased Appetite). Confirmatory factor analyses supported the structure with fit indexes exceeding 0.90. The multidimensional framework of the MNWS correlated as expected with health status, depicted an expected course of withdrawal symptoms over time, predicted the sensitivity of withdrawal symptoms on subsequent cessation, and produced internal reliability estimates above 0.70. CONCLUSIONS: Evidence is obtained to support the validity and reliability of the multidimensional structure of the nine-item MNWS. The data suggest that the MNWS has individual constructs on Negative Affect (depressed mood; irritability, frustration, or anger; anxiety; difficulty concentrating), Insomnia (difficulty going to sleep; difficulty staying asleep), Craving, Restlessness, and Increased Appetite. As such, analyzing each construct separately would strengthen the analysis of the popular MNWS.

Adolescent↗
PubMed2004

A new approach for interval estimation and hypothesis testing of a certain intraclass correlation coefficient: the generalized variable method.

We consider the problems of interval estimation and hypothesis testing for the intraclass correlation coefficient in an interrater reliability study when both raters and subjects are assumed to be randomly selected from populations of raters and subjects, respectively. We propose a novel approach for the confidence interval estimation and hypothesis testing using the concepts of generalized confidence interval (GCI) and generalized P-values. A simulation study is conducted to investigate the coverage probabilities of the GCI approach relative to the modified large sample (MLS) approach. Both methods tend to provide somewhat conservative coverage. Relative to the MLS approach, the GCI approach is closer to the correct (nominal) coverage for a two-sided interval, but farther to the correct coverage for a one-sided lower interval. Unlike the MLS approach, the GCI approach can also easily provide P-values. The fact that the GCI approach is suitable for confidence interval estimation and obtaining P-values makes the GCI approach a suitable candidate for making inference about interrater reliability.

Algorithms↗
PubMed2004

Patient satisfaction and glycemic control after 1 year with inhaled insulin (Exubera) in patients with type 1 or type 2 diabetes.

OBJECTIVE: The aim of this study was to determine patient satisfaction in patients with type 1 or type 2 diabetes receiving an inhaled insulin or subcutaneous insulin regimen, as assessed by pooled analysis of two 12-week parent studies and 1-year extension studies. RESEARCH DESIGN AND METHODS: In the 12-week parent studies, patients with type 1 (n = 70) or type 2 (n = 51) diabetes were randomized to an inhaled insulin or subcutaneous insulin regimen. In the 1-year extension studies, patients were allowed to select either treatment regimen. Patient satisfaction was assessed at baseline, week 12, and 1 year using the Patient Satisfaction with Insulin Therapy questionnaire. RESULTS: Of the 60 patients who received inhaled insulin during the parent studies, 85.0% (n = 51) chose to continue treatment, 13.3% (n = 8) switched to subcutaneous insulin, and 1.7% (n = 1) did not continue. Of the 61 patients who received subcutaneous insulin, 21.3% (n = 13) chose to continue treatment, 75.4% (n = 46) switched to inhaled insulin, and 3.3% (n = 2) did not continue. From baseline (parent studies) to 1 year (extension studies), HbA(1c) reductions of 0.8% were sustained, and greater improvements were observed in the inhaled insulin group compared with the subcutaneous insulin group in terms of overall satisfaction (37.9 vs. 3.1%; P < 0.01) and ease of use (43.2 vs. -0.9%; P < 0.01). CONCLUSIONS: Inhaled insulin was preferred over subcutaneous insulin, which resulted in greater patient satisfaction up to 1 year in patients with type 1 or type 2 diabetes with durable effects on HbA(1c) levels.

Administration, Inhalation↗
PubMed2003

A modified large-sample approach to approximate interval estimation for a particular intraclass correlation coefficient.

We consider the problem of constructing a confidence interval for the intraclass correlation coefficient in an interrater reliability study when both raters and subjects are random effects in a two-way random effects model. A simulation study is conducted to investigate and compare the interval coverage per cents of three methods of approximation: (i) Satterthwaite's two moments, the standard approach; (ii) modified three moments, a newer approach; and (iii) modified large sample, the newest approach for this particular problem. One-sided lower and two-sided bounds are examined. For the two-moment approach, coverage of confidence intervals can be understated for not only one-sided bounds but also two-sided bounds. Coverage of confidence intervals for the modified large-sample approach is either correct or conservative and provides narrower two-sided widths than the modified three-moment approach, which can understate coverage on one-sided and two-sided bounds for two or three raters. The competing methods are illustrated with data from a reliability study of four raters evaluating the number of decayed, missing, and filled surfaces in the permanent teeth of ten subjects. Overall, the modified large-sample approach provides the most satisfactory performance of the three methods.

Clinical Trials as Topic↗
PubMed2003

Treatment responsiveness of the Self-Esteem And Relationship questionnaire in erectile dysfunction.

OBJECTIVES: To determine the treatment responsiveness of the disease-specific Self-Esteem And Relationship (SEAR) questionnaire in erectile dysfunction. METHODS: The SEAR questionnaire was administered at baseline and at the end of the study in 93 patients with erectile dysfunction enrolled in a 10-week, open-label, flexible-dose (50-mg sildenafil, adjustable to 25 mg or 100 mg) trial. Changes from the baseline score were analyzed using the paired t test. The correlation between the changes from baseline on the SEAR questionnaire and the Erectile Function domain of the International Index of Erectile Function was examined. RESULTS: Significant and meaningful differences (P = 0.0001) from baseline were observed in the two primary domains (Sexual Relationship and Confidence) and the two Confidence domain subscales (Self-Esteem and Overall Relationship). The magnitude of the change was quite high for most aspects (Sexual Relationship, effect size [ES] = 1.6; Confidence, ES = 1.0; Self-Esteem, ES = 1.1) and moderate for one (Overall Relationship, ES = 0.6). Changes in Erectile Function domain score correlated moderately with changes in the SEAR domain and subscale scores (Sexual Relationship, r = 0.69; Confidence, r = 0.48; Self-Esteem, r = 0.47; and Overall Relationship, r = 0.35; P <or=0.001). CONCLUSIONS: The SEAR questionnaire is responsive to effective treatment of erectile dysfunction. These data suggest that the SEAR questionnaire is a valid instrument for detecting psychosocial gains from beneficial intervention.

Adult↗
PubMed2002

Treatment satisfaction in type 2 diabetes: a comparison between an inhaled insulin regimen and a subcutaneous insulin regimen.

BACKGROUND: In patients with type 2 diabetes, published data suggest that glycemic control can be achieved as effectively with an inhaled insulin regimen (preprandial inhaled intrapulmonary insulin plus a single bedtime Ultralente injection) as with a conventional subcutaneous insulin regimen involving 2 to 3 injections per day. It is unknown whether inhalation delivery of insulin improves patient satisfaction. OBJECTIVE: Our objective was to compare patient satisfaction between an inhaled insulin regimen and a subcutaneous insulin regimen. METHODS: This was a 12-week randomized, open-label, parallel-group, controlled trial in patients with type 2 diabetes. They were randomized to receive either a subcutaneous insulin regimen (split/mixed insulin with 2 to 3 injections daily) or an inhaled insulin regimen (inhaled insulin before meals and a single Ultralente insulin injection at bedtime). Change in glycosylated hemoglobin (HbA1c) from baseline to week 12 was the study's primary end point. At baseline and week 12, patients completed a questionnaire (Patient Satisfaction with Insulin Therapy Questionnaire) covering attributes of patient satisfaction. Treatment regimens were compared on each item with the Wilcoxon rank sum test and on the overall score with a t test. RESULTS: Fifty-one patients (age range, 35-65 years) participated in the study, 26 receiving inhaled insulin and 25 receiving subcutaneous insulin. Forty-seven patients (22 inhaled insulin, 25 subcutaneous insulin) completed the satisfaction questionnaire. The mean percent improvement in overall satisfaction with an inhaled insulin regimen (31%; 95% CI, 14-50) was significantly greater (P < 0.05) than that with a subcutaneous insulin regimen (13%; 95% CI, 7-19). Increases in overall satisfaction correlated with improvements in glycemic control (r = 0.30; P < 0.05). Both treatment regimens experienced a mean HbA1c reduction of approximately 0.7%. Although patient satisfaction was the chief focus of this article, these results should be considered exploratory, as the trial was powered prospectively for HbA1c values (the primary end point) and not for patient satisfaction. CONCLUSIONS: Administration of an inhaled insulin regimen may offer the first practical, noninvasive alternative to insulin injections. In the patients with type 2 diabetes studied, an inhaled insulin regimen with the need for only 1 subcutaneous injection at bedtime appeared to offer more ease of use, comfort, and convenience, as well as greater overall satisfaction, than a subcutaneous insulin regimen of 2 to 3 injections daily.

Administration, Inhalation↗
PubMed2002

Assessing the clinical significance of single items relative to summated scores.

How many items are needed to measure an individual's quality of life (QOL)? This article describes the strengths and weaknesses of single items and summated scores (from multiple items) as QOL measures. We also address the use of single global measures vs multiple subindices as measures of QOL. The primary themes that recur throughout this article are the relationships between well-defined research objectives, the research setting, and the choice single item vs summated scores to measure QOL. The conceptual framework of the study, the conceptual fit with the measure, and the purpose of the assessment should all be considered when choosing a measure of QOL. No "gold standard" QOL measure can be recommended because no "one size fits all." Single items have the advantage of simplicity at the cost of detail. Multiple-item indices have the advantage of providing a complete profile of QOL component constructs at the cost of increased burden and of asking potentially irrelevant questions. The 2 types of indices are not mutually exclusive and can be used together in a single research study or in the clinical setting.

Chronic Disease↗
PubMedDate not supplied

Regulatory issues for health-related quality of life--PhRMA Health Outcomes Committee workshop, 1999.

INTRODUCTION: Health-related quality-of-life (HRQL) can be defined as the impact of disease and treatment across the physical, psychological, social and somatic domains of functioning and well-being. Health-related quality-of-life measures are included in clinical trials of drug treatment to assess the impact of therapy on the patient's functioning. HRQL guidance could allow for use of this data in drug labeling and promotion. OBJECTIVES: The aim of our study was to provide recommendations with respect to regulatory issues important to the development of guidelines for HRQL research. METHODS: The HRQL workshop was planned jointly by members of the Pharmaceutical Research and Manufacturers of America Health Outcomes Committee and the Division of Drug Marketing, Advertising, and Communications of the Food and Drug Administration. The workshop was limited to six regulatory issues related to HRQL research in clinical trials of pharmaceutical therapies. These six issues were: instrument selection and validation, study design, data analysis, HRQL and safety, clinical meaning, and promotional use. Before the meeting, a consensus was reached that HRQL does not measure, nor should it be used to measure, safety. Therefore, five work groups discussed HRQL issues and made recommendations. RESULTS: Overall, the workshop recommended that HRQL measures be treated as any other clinical end point. The workshop recognized that research in HRQL methods is ongoing and that any guidance should be flexible to allow for changes in this developing research area. CONCLUSIONS: HRQL provides a patient perspective on the impact of disease and therapy on patients' daily life and functioning. Including HRQL information in promotion could be beneficial to decision making on the use of therapies. HRQL is a measure of effectiveness, not safety, and should be treated as any other clinical end point.

Clinical Trials as Topic↗
PubMedDate not supplied

Hierarchical construct validity of the treatment satisfaction questionnaire for medication (TSQM version II) among outpatient pharmacy consumers.

OBJECTIVES: The objectives of this study were twofold: 1) to evaluate the construct validity of the Treatment Satisfaction Questionnaire for Medication (TSQM v. II) using structural equation modeling (SEM); and 2) to assess its concurrent validity using medication adherence criteria. METHODS: Pharmacy patients filling a new medication prescription (n = 342) were recruited from 14 Michigan pharmacies to participate in a 4-week treatment satisfaction study. The TSQM v. II was tested for model fit against an established theoretical model (the Decisional Balance Model of Treatment Satisfaction) using hierarchical confirmatory factor analysis (HCFA). Regression and discriminant analytic models were used to examine the criterion-related validity of the measure. RESULTS: An exploratory factor analysis, used for TSQM v. II item reduction, revealed a strongly dimensional instrument (Effectiveness, Side Effects, and Convenience) and explained 88% of total pooled variance. Results of an HCFA using the final TSQM v. II items suggested a good model fit with the data (P > 0.54). In support of concurrent validity, the TSQM scales explained between 9% and 20% of the variance in dosing adherence and 60% of the variance in the likelihood of future use. Discriminant analysis demonstrated the superior classification power of the hierarchical model of treatment satisfaction over the discrete attribute model when predicting medication discontinuation. CONCLUSIONS: The TSQM v. II has equivalent measurement characteristics as the TSQM v. I, yet uses four fewer items and more consistent wording. The value of the Decisional Balance Model for estimation of dosing adherence and medication persistence over time is discussed.

Aged↗
PubMedDate not supplied

Association between the Erectile Dysfunction Inventory of Treatment Satisfaction and the Self-Esteem and Relationship Questionnaire following treatment with sildenafil citrate for men with erectile dysfunction.

OBJECTIVES: Research is lacking on the correlation between treatment satisfaction and confidence, self-esteem, and relationships for men receiving treatment for erectile dysfunction (ED). We sought to correlate scores between the validated Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS) index and the validated Self-Esteem And Relationship (SEAR) questionnaire following treatment with sildenafil citrate (VIAGRA). METHODS: This study was based on an open-label, flexible-dose trial of 93 sildenafil-naive patients with ED. Pearson correlation coefficients between EDITS index and SEAR questionnaire scores, each of which can range from 0 to 100 (most favorable), were calculated at end of treatment (EOT). An analysis of covariance model was applied to associate changes from baseline to EOT in SEAR scores with EDITS score at EOT, controlling for baseline SEAR score. RESULTS: Significant and sizable Pearson's correlations between SEAR and EDITS scores (P < or = 0.0001; range: 0.49-0.84) were observed. A 10-point higher EDITS scores at EOT corresponded to a significant and tangible average improvement in SEAR scores from baseline to EOT (P < or = 0.0001; range: 6.6-8.7). Average SEAR scores at EOT were markedly different between patients with greater treatment satisfaction at EOT (EDITS score > or = median EDITS score of 88.6; n = 50) and those with lesser treatment satisfaction at EOT (EDITS score <88.6; n = 43). CONCLUSIONS: The data add to the validity of the SEAR questionnaire, suggest a tangible relationship between treatment satisfaction and psychosocial benefit among men with ED treated with sildenafil, and highlight the importance of assessing the psychosocial impact of ED in men undergoing treatment.

Adult↗