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Biomedical subjects

Kent H Summers

Publications and source records attributed to Kent H Summers.

12 recordsLinked to original sources
PubMed2005

Quality of life of women with urinary incontinence: cross-cultural performance of 15 language versions of the I-QOL.

Urinary incontinence (UI) has substantial and important impacts on health-related quality of life. The purpose of this research is to report the psychometric performance of 15 different language versions of the Incontinence-specific Quality of Life (I-QOL)measure, a patient-reported outcome measure specific to stress, urge and mixed urinary incontinence. The multi-national dataset consisted of data from four clinical trials for stress incontinent females and from two additional population studies, enrolling women with stress, urge and mixed UI. All enrolled patients completed the I-QOL and comparative measures at baseline. The clinical trial populations had multiple administrations up to 12 weeks, and the two population studies included a shorter retest. Country-specific psychometric testing for validity, reliability, and responsiveness followed standardized procedures. Confirmatory factor analyses were performed to assess the I-QOL subscales. The I-QOL measurement model was confirmed as three subscales. Summary and subscale scores for the 15 versions were internally consistent (alpha values = 0.91-0.96) and reproducible (ICC = 0.72-0.97). Using changes in the independent measures of incontinence episode frequency standardized response means were predominantly strong (ranged 0.71-1.05) across 13 versions (out of 15) in association with these measures and effect sizes. These additional language versions of the I-QOL instrument demonstrate psychometric properties similar to the original version. The I-QOL has shown good results in both community studies and clinical trials with varying types and severity of urinary incontinence. It is a reliable and valid measure of HRQOL, suitable for use in a variety of international settings.

Adult↗
PubMed2005

Outcomes of American Lung Association-Indiana Lung Centers asthma program.

The American Lung Association of Indiana (ALA-I), in conjunction with participating Indiana hospitals, developed the Lung Center concept as a mechanism to provide standardized delivery of lung health education. The goal of this pilot study was to evaluate initial experience with the Lung Center program "Overcoming Your Asthma," a two-session asthma education program, and identify areas needing improvement. A total of 305 participants responded to a 31-item questionnaire at baseline (immediately prior to program exposure) and again at 1 month (n = 75) and 6 months (n = 30) after participation. Overall, delivery of the ALA-I Lung Center asthma education program improved respondents' experience with asthma. At one month after the educational session, the program improved participant knowledge about asthma. This was associated with modest improvements in treatment behaviors, economic outcomes and asthma symptoms such as reduced breathing difficulties, wheezing and asthma exacerbations, and improvement in sleep. Improvements were not uniformly sustained at 6 months. In summary, the Lung Center asthma education program appears to benefit patients with asthma. The results provide preliminary evidence to support continued delivery of asthma education in Lung Centers. Future efforts should emphasize education to improve treatment attitudes and behaviors.

Asthma↗
PubMed2005

Comparison of costs and utilization between users of insulin lispro versus users of regular insulin in a managed care setting.

OBJECTIVE: To compare medical and pharmacy costs and utilization between patients with diabetes who received insulin lispro versus regular human insulin. METHODS: A retrospective analysis of medical and pharmacy claims was conducted among continuously enrolled users of insulin lispro or regular insulin during the identification period, March 1, 2000, through February 28, 2001, within a large managed care organization. This study improved upon the methodology used in previous studies by (a) stratifying (rather than 1:1 matching) individuals by their likelihood to use insulin lispro using the propensity score binning technique, and (b) refining the study inclusion criteria to include only patients with 3 or more fills of the insulin under study (lispro or regular) to exclude individuals who may have been on either product for a short time. Because the propensity score binning technique groups patients with similar baseline characteristics within strata (bins) and not among individual patients, almost the entire available sample is retained in the analysis, unlike propensity score matching, where large numbers of patients can be excluded depending on the matching scheme. Therefore, the propensity score binning technique, because it uses more complete information, is less likely to produce biased results. Patients were grouped into 5 bins (quintiles) based on their estimated likelihood to receive insulin lispro rather than regular insulin. The propensity score model used baseline characteristics of age, gender, comorbidities, use of oral antidiabetic medications, prescription copayment, and diabetes-related costs and utilization. Overall cost and utilization differences (lispro minus regular insulin) during the 12-month follow-up period were calculated using weights inversely proportional to variances of within-bin differences. RESULTS: Of 6,436 patients, 1,972 (30.6%) received insulin lispro and 4,464 (69.4%) received regular insulin. The propensity score estimation produced 5 bins, each containing between 1,287 and 1,288 patients, utilizing all patients in the analysis. Patients in the lower-numbered propensity score quintiles were older, more likely to use oral antidiabetic medications, and had more comorbidities than those in the higher-numbered quintiles. As quintile number increased, the percentage of insulin lispro users also increased. The weighted mean annual cost difference (lispro minus regular insulin) per patient was + USD 79 (P < 0.001) for diabetes-related pharmacy cost, + USD 212 (P < 0.001) for total pharmacy cost, USD 75 (P < 0.857) for diabetes-related medical cost, USD 2,286 (P <0.011) for nondiabetes medical cost, and USD 2,327 (P = 0.072) for total medical cost. CONCLUSIONS: Compared with regular insulin users, insulin lispro users incurred higher diabetes-related and total pharmacy costs but lower nondiabetes medical costs and similar total medical costs. Fewer hospitalizations among insulin lispro as compared with regular insulin users contributed to lower nondiabetes medical costs and similar total medical costs.

Age Factors↗
PubMed2005

Relationships between hyperglycemia and cognitive performance among adults with type 1 and type 2 diabetes.

OBJECTIVE: Hyperglycemia is a common event among patients with type 1 and type 2 diabetes. While the cognitive-motor slowing associated with hypoglycemia is well documented, the acute effects of hyperglycemia have not been studied extensively, despite patients' reports of negative effects. This study prospectively and objectively assessed the effects of hyperglycemia on cognitive-motor functioning in subjects' natural environment. RESEARCH DESIGN AND METHODS: Study 1 investigated 105 adults with type 1 diabetes (mean age 37 years and mean duration of diabetes 20 years), study 2 investigated 36 adults with type 2 diabetes (mean age 50 years and mean duration of diabetes 10 years), and study 3 investigated 91 adults with type 1 diabetes (mean age 39 years and mean duration of diabetes 20 years). Subjects used a hand-held computer for 70 trials over 4 weeks, which required them to complete various cognitive-motor tasks and then measure and enter their current blood glucose reading. RESULTS: Hyperglycemia (blood glucose >15 mmol/l) was associated with slowing of all cognitive performance tests (P < 0.02) and an increased number of mental subtraction errors for both type 1 and type 2 diabetic subjects. The effects of hyperglycemia were highly individualized, impacting approximately 50% of the subjects. CONCLUSIONS: Acute hyperglycemia is not a benign event for many individuals with diabetes, but it is associated with mild cognitive dysfunction.

Adult↗
PubMed2004

Preference for insulin delivery systems among current insulin users and nonusers.

BACKGROUND: It is not known whether preferences for the vial and syringe (VS) or the insulin injection pen device (IIPD) differ between current insulin users and nonusers. Additional benefits in treatment might be realized if preference were considered when discussing insulin use with patients initiating or changing insulin treatment. OBJECTIVE: The objective of this study was to examine respondent preferences for the VS and the IIPD between current insulin users and nonusers. METHODS: US residents with type 1 or 2 diabetes mellitus who responded to a year-2001 mail survey completed a 19-item self-administered questionnaire designed to assess respondents' expectations of attributes related to the VS and IIPD. Items were analyzed on a 5-point Likert-type scale with higher scores indicating greater agreement that attributes met expectations. Composite scores for ease of use, activity interference, and social acceptability were used to further examine differences between insulin users and nonusers regarding their preferences for the VS or IIPD. Observed differences in preferences were evaluated statistically using the chi-square test, paired Student t test, and regression analysis. RESULTS: Questionnaires were received from 302 respondents, producing an adjusted response rate of 20.8%. Respondents ranged in age from 18 to 83 years (mean [SD], 52.4 [13.2] years), with 62% reporting annual income above 25,000 US dollars. Of the 242 usable responses, 99 respondents were insulin users and 143 were not. Statistical evaluation using analysis of variance revealed significant regression coefficients (P < or = 0.001) for both insulin users and nonusers for each of the 3 dimensions (ease of use, activity interference, and social acceptability with respect to preference). CONCLUSIONS: Based on this survey analysis, overall preference for the IIPD appeared to be higher compared with the VS among both insulin users and nonusers. Social acceptability was the strongest predictor of preference for the IIPD. For current insulin users, social acceptability and ease of use were significant predictors of preference for the VS. For insulin nonusers, these results suggested that patient discussions about VS should emphasize activity interference and ease of use.

Adolescent↗
PubMed2004

Clinical practice guidelines on the initial assessment and treatment of urinary incontinence in women: a US focused review.

OBJECTIVE: To identify clinical practice guidelines from prominent US organizations for the initial management of urinary incontinence (UI) in women and compare them with recommendations from the International Consultation on Incontinence (ICI). The challenge of implementing guidelines in the US was also identified. METHODS: The medical literature was reviewed to identify relevant practice guidelines on the initial management of UI in community-dwelling women according to specific inclusion and exclusion criteria. Guidelines were compared with the ICI international gold standard relating to patient identification, initial therapy, and recommendation for specialist referral. Literature on programs to implement guidelines into clinical practice was reviewed. RESULTS: There is general agreement on how females with UI should be initially managed based on guidelines, monographs, and technical bulletins from prominent US organizations. Though these recommendations are more than 5 years old, they are fairly similar to the latest guidelines developed by the ICI in 2001. Minor discrepancies are mainly related to the lack of updating US guidelines based on most recent knowledge. Implementing existing guidelines into clinical practice presents a challenge. CONCLUSION: No evidence-based practice guidelines from prominent US organizations on the initial management of UI in women exist that are less than 5 years old, but the latest versions are in alignment with recent ICI/WHO guidelines. Although optimization of UI management may be the goal of guidances, the debate remains over whether these recommendations are actually effective in modifying practice. Simplifying and updating guidelines regularly may enhance adaptation in the initial management of UI in women.

Evidence-Based Medicine↗
PubMed2004

Development of an instrument to assess expectations of and preference for an insulin injection pen compared with the vial and syringe.

BACKGROUND: Before using a product, patients form expectations regarding the extent of a product's desirable attributes. These expectations can be used to understand their preference and anticipate potential satisfaction with the product. OBJECTIVE: The aim of this study was to produce a valid and reliable data collection instrument (the Insulin Injection Preference questionnaire [IIP-q]) to measure expectations of and preference for the insulin injection pen compared with the vial and syringe. METHODS: This study was initiated at the University of Mississippi (University, Mississippi). The IIP-q was developed to determine the extent to which respondents' prepurchase expectations of a product's attributes relate to preference for an insulin injection pen compared with the vial and syringe. Instrument development began with item generation related to product attributes important to patients who inject insulin. Items originated from an extensive search of the peer-reviewed Internet-based literature, marketing reports, clinical studies, and existing instruments. Content validity also was assessed using expert panel and focus group review. The resultant instrument (the IIP-q) was mailed to 1200 patients known to have type 1 or type 2 diabetes mellitus who either did or did not use insulin. Subscales were identified through exploratory factor analysis. Reliability and validity were assessed using Cronbach alpha for subscale items. Product-moment correlations between subscale dimensions and 2 global measures of preference were used to test the relationship between attribute expectations and preference. RESULTS: Seventeen of the questionnaires were returned as undeliverable, leaving 1183 in the sample population. Questionnaires were received from 302 individuals, 55 of whom failed to complete > or = 85% of the items and thus were not included in the final analysis. Of the 247 respondents (135 women, 112 men; mean [SD] age, 52.4 [13.2] years (range, 18-83 years]), 99 (40.1%) were current insulin users and 143 (57.9%) were not using insulin. Exploratory factor analysis resulted in a 13-item solution (Cronbach alpha = 0.92), accounting for 73.6% of the total explained variance. Ease of use, activity interference, and social acceptability emerged as expectation subscales from exploratory factor analysis. Cronbach alpha for items comprising the subscales ranged from 0.82 to 0.92. The 3 subscales were significantly correlated with patient preference (ease of use, r = 0.520, P < 0.001; activity interference, r = 0.570, p < 0.001; social acceptability, r = 0.602, p < 0.001). CONCLUSIONS: The results of the present study provide support for the IIP-q as a reliable and valid instrument to assess patient expectations of product attributes and preference. This instrument can be modified for use in clinical trials to determine the role of patient expectations and preference in their judgments regarding satisfaction with insulin delivery devices.

Cross-Sectional Studies↗
PubMed2003

Diabetic retinopathy: contemporary prevalence in a well-controlled population.

OBJECTIVE: To measure the extent to which modern intensified risk factor control has lessened the duration-specific prevalence of diabetic retinopathy and, therefore, has decreased the risk of blindness in Americans with type 2 diabetes. RESEARCH DESIGN AND METHODS: Intensified control of blood glucose and blood pressure has prevented diabetic retinopathy in randomized controlled trials. There is as yet no confirmation that subsequent treatment intensification in the community has had the same result. We identified all 6993 members of a health maintenance organization, Kaiser Permanente Northwest (KPNW), who, in 1997-1998, had dilated retinal examinations and verifiable data of diagnosis of type 2 diabetes. We plotted prevalence by time since diagnosis for background diabetic retinopathy (BDR) and proliferative diabetic retinopathy (PDR) and compared these results to identically derived 1980-1982 results from the Wisconsin Epidemiologic Study of Diabetic Retinopathy (WESDR). We estimated multivariate predictive models. RESULTS: Mean (+/- SD) HbA(1c) in KPNW was 7.84 +/- 1.26% versus 10.37% (standardized) in the WESDR. KPNW blood pressure averaged 138.6 +/- 13.8/79.5 +/- 7.4 mmHg compared with 147.0/79.0 in the WESDR. BDR was much less prevalent in KPNW, but PDR prevalence appeared unchanged. BDR preceded diagnosis in 20.8% of the WESDR subjects but only 2.0% of KPNW subjects. However, in both populations, the first cases of PDR appeared similarly, soon after diagnosis. CONCLUSIONS: Earlier diagnosis and more aggressive control of blood glucose and blood pressure decreased the duration-adjusted prevalence of background, but not of sight-threatening proliferative retinopathy. More population-based research is needed to replicate and explain this unexpected finding. Detecting and treating PDR should not be neglected on the assumption that risk-factor control has minimized its prevalence.

Blood Glucose↗
PubMed2002

Productivity and medical costs of diabetes in a large employer population.

OBJECTIVE: The purpose of this study was to assess the economic burden of diabetes from an employer's perspective. We analyzed the costs of diabetes, using claims data for an employed population and the prevalence of selected comorbid conditions. RESEARCH DESIGN AND METHODS: The data source is a claims database from a national Fortune 100 manufacturer. It includes medical, pharmacy, and disability claims for all beneficiaries (n >100,000). Both medical and work productivity costs of diabetes patients are compared by age with those of matched control subjects from the overall beneficiary population. Out-of-pocket and intangible costs are excluded. RESULTS: In 1998, the employer's mean annual per capita costs were higher for all diabetes beneficiaries than for control subjects ($7,778 +/- 16,176 vs. $3,367 +/- 8,783; P < 0.0001), yielding an incremental cost of $4,410 +/- 18,407 associated with diabetes. The medical and productivity costs for employees with diabetes were significantly (P < 0.0008) higher than for control subjects. The incremental cost of diabetes among employees ranged from $4,671 (aged 18-35 years) to $4,369 (aged 56-64 years). CONCLUSIONS: Diabetes imposes a significant economic burden on employers, particularly when including productivity costs. Employers should select health plans that provide enriched benefits to diabetes patients, including ready access to medical and pharmacy services as well as aggressive diabetes management programs.

Adolescent↗
PubMedDate not supplied

Cost and utilization comparisons among propensity score-matched insulin lispro and regular insulin users.

OBJECTIVE: To compare cost and utilization among users of insulin lispro and regular (human) insulin. METHODS: This was a retrospective analysis using administrative claims data for continuously enrolled subjects using insulin lispro or regular insulin between January 1, 1998, and December 21, 1999. Subjects were matched 1 to 1 on the propensity to receive lispro versus regular insulin using a score estimated from baseline characteristics such as age, gender, comorbidities, and oral hypoglycemic use. Once matched, 12 months of follow-up pharmacy and medical cost and utilization data (e.g. prescriptions, office visits, hospitalizations) from July 1,1997, through December 31, 2000, were analyzed using univariate statistics. RESULTS: Of 11,443 subjects, 3,341 (29.2%) had received a prescription for insulin lispro, while 8,102 (70.8%) had received a prescription for regular insulin. At baseline, lispro subjects tended to be younger, more often had type 1 diabetes and a history of insulin use, had fewer comorbidities, visited endocrinologists more often than family practice physicians, and had lower total costs. After matching on propensity score to within +/-0.01, 1,832 subject pairs were retained. On average, lispro subjects had significantly more office visits (P=0.0022) and pharmacy prescriptions (P=0.0165) but fewer inpatient hospital visits (P=0.0028)compared to regular insulin subjects. Cost results were similar, with insulin lispro subjects having significantly higher average office visit costs (P=0.0237) and pharmacy costs (P<0.0001) but lower inpatient hospital costs (P=0.0227). Total costs were not significantly different between treatment groups (P=0.5266). CONCLUSION: Total direct health care costs were not different between insulin lispro and regular insulin users. An association was observed between higher direct drug product cost and more intensive ambulatory care for insulin lispro users and lower inpatient hospital cost in the short-term.

Administration, Oral↗
PubMedDate not supplied

A comparison of clinical practice guidelines in the initial pharmacological management of new-onset epilepsy in adults.

OBJECTIVE: Clinical practice guidelines (CPGs) are intended not only to provide supportive information for health care providers but also to act as a guide for health care policy decisions. However, extant CPGs do not always reach the same conclusions. The objective of this study was to compare recommendations for initial pharmacological treatment of new-onset epilepsy in adults as stated within published CPGs. METHODS: We performed a systematic review of CPGs, which were published by prominent national organizations between January 2000 and June 2005, regarding the initial pharmacological treatment of epilepsy in adults. RESULTS: Five CPGs and 1 evidence report were identified that focus on pharmaceutical management in epilepsy. The 3 guidelines most relevant to the question of new-onset epilepsy treatment in adults were developed by the American Academy of Neurology (AAN), Scottish Intercollegiate Guidelines Network (SIGN), and National Institute for Health and Clinical Excellence (NICE). AAN recommends the use of both recently introduced antiepileptic drugs (AEDs: gabapentin, lamotrigine, topiramate, and oxcarbazepine) and standard agents (carbamazepine, phenytoin, valproic acid/divalproex, and phenobarbital) in newly diagnosed epilepsy, i.e., a nontiered approach. Alternatively, NICE recommends using newer AEDs (lamotrigine, topiramate, and oxcarbazepine) only in patients who derive no benefit from older agents--a tiered approach. SIGN notes that all AEDs licensed for monotherapy have similar efficacy in newly diagnosed epilepsy--a recommendation for a nontiered approach. The newer AEDs (lamotrigine and oxcarbazepine) are recommended as first-line initial treatment as are standard agents (carbamazepine and valproic acid/divalproex). The NICE guideline includes economic and quality-of-life evidence in their recommendations while AAN and SIGN do not. In these regards, current data fails to show superiority for newer agents. CONCLUSION: In the past 5 years, several CPGs have been published in epilepsy management. Only 3 guidelines have explicit recommendations for initial pharmacological treatment of adults with epilepsy. With some variation regarding which medications are recommended from each group, all CPGs promote standard and newer AEDs as having similar clinical efficacy. Until efficacy, quality of life, or cost data for the newer agents demonstrates a superior outcome, older AEDs remain viable options as first-line for monotherapy in newly diagnosed patients and may provide cost benefits over newer agents.

Adult↗