A systematic review of diabetes disease management programs.

OBJECTIVE: To systematically evaluate and synthesize published evidence regarding the effect of disease management programs for patients with diabetes mellitus on processes and outcomes of care. STUDY DESIGN: Systematic literature review and meta-analysis. PATIENTS AND METHODS: Computerized databases were searched for English-language controlled studies assessing the effect of diabetes disease management programs published from 1987 to 2001. Two reviewers extracted study data using a structured abstraction form. Pooled estimates of program effects on glycated hemoglobin were calculated using an empirical Bayes model. RESULTS: The pooled estimate of program effects on glycated hemoglobin was a 0.5-percentage point reduction (95% confidence interval, 0.3 to 0.6 percentage points), a modest but significant improvement. Evidence also supports program benefits in improving screening for retinopathy and foot lesions. CONCLUSIONS: Diabetes disease management programs can improve glycemic control to a modest extent and can increase screening for retinopathy and foot complications. Further efforts will be required to create more effective disease management programs for patients with diabetes mellitus.

The association between quality improvement activities performed by managed care organizations and quality of care.

PURPOSE: Little data are available to assess the efforts of managed care organizations to improve quality of care. This analysis assessed differences in performance rates between organizations with and without quality improvement activities. METHODS: We reviewed 399 self-reported quality improvement activities submitted by organizations seeking accreditation by the National Committee for Quality Assurance. Processes or outcomes assessed in quality improvement activities were linked to corresponding measures in the effectiveness-of-care database of the Health Plan Employer Data and Information Set (HEDIS). Performance rates for managed care organizations with and without quality improvement activities were then compared. RESULTS: The cross-sectional analysis included 79 quality improvement activities from 50 organizations, covering 12 effectiveness-of-care categories. Each activity had a matching performance score in the database. Financial incentives for providers were associated with substantially higher performance rates in organizations employing this type of intervention. Eight effectiveness-of-care categories had at least four organizations reporting specific quality improvement activities for the care category of interest; statistically significant improvements were observed for follow-up visits for patients after hospitalization for mental illness, checkups after delivery, and screening for cervical cancer. CONCLUSION: Based on objective and audited information, the estimated effects of self-reported quality improvement activities were often small and inconsistent. In some instances, the observed effect was contrary to the expected direction. Limitations of the available dataset and the caveats of a cross-sectional study design precluded a number of analytical options. Longer-term, prospective studies are needed to explore further the relation between quality improvement activities and objective measures of clinical performance.

Does disease management improve clinical and economic outcomes in patients with chronic diseases? A systematic review.

PURPOSE: To assess the clinical and economic effects of disease management in patients with chronic diseases. METHODS: Electronic databases were searched for English-language articles from 1987 to 2001. Articles were included if they used a systematic approach to care and evaluated patients with chronic disease, reported objective measurements of the processes or outcomes of care, and employed acceptable experimental or quasi-experimental study designs as defined by the Cochrane Effective Practice and Organization of Care Group. RESULTS: Two reviewers evaluated 16,917 titles and identified 102 studies that met the inclusion criteria. Identified studies represented 11 chronic conditions: depression, diabetes, rheumatoid arthritis, chronic pain, coronary artery disease, asthma, heart failure, back pain, chronic obstructive pulmonary disease, hypertension, and hyperlipidemia. Disease management programs for patients with depression had the highest percentage of comparisons (48% [41/86]) showing substantial improvements in patient care, whereas programs for patients with chronic obstructive pulmonary disease (9% [2/22]) or chronic pain (8% [1/12]) appeared to be the least effective. Of the outcomes more frequently studied, disease management appeared to improve patient satisfaction (71% [12/17]), patient adherence (47% [17/36]), and disease control (45% [33/74]) most commonly and cost-related outcomes least frequently (11% to 16%). CONCLUSION: Disease management programs were associated with marked improvements in many different processes and outcomes of care. Few studies demonstrated a notable reduction in costs. Further research is needed to understand how disease management can most effectively improve the quality and cost of care for patients with chronic diseases.

Utilization of nonsteroidal anti-inflammatory drugs and antisecretory agents: a managed care claims analysis.

PURPOSE: To describe patients initiating nonsteroidal anti-inflammatory drug (NSAID) therapy with regard to gastrointestinal and cardiac risks and patterns of antisecretory agent use, and to explore the relation between therapy type and subsequent outcomes. METHODS: We studied patients aged 18 years or older who had continuous coverage from 1998 to 2001 and who had initiated treatment with cyclooxygenase-2 (COX-2) selective inhibitors or nonselective NSAIDs. Patients were categorized with respect to gastrointestinal and cardiac risk profiles. Proton pump inhibitor use within 15 days of initiating NSAID therapy was considered prophylactic. Logistic regression analysis was used to evaluate associations between treatment and hospitalization events, cardiac events, and health care costs. RESULTS: We identified 106,564 eligible NSAID initiators: 65.2% used COX-2 inhibitors and 34.8% used traditional NSAIDs. Users of COX-2 inhibitors were more likely to be at higher risk of gastrointestinal bleeding and cardiac events than were NSAID users. Proton pump inhibitor prophylaxis was most common among users of COX-2 inhibitors, but was only 11% in patients at high risk of gastrointestinal bleeding. There were no differences among treatment groups in terms of gastrointestinal or cardiac events. Initiation of COX-2 inhibitor therapy was associated with greater total health care costs. CONCLUSION: Although we found that COX-2 inhibitors were used more frequently than were traditional NSAIDs in certain groups of patients with varying cardiac or gastrointestinal risk, we did not find that their use resulted in reductions in clinical events, cotherapy with proton pump inhibitors, or costs, suggesting that a better understanding of the relation between NSAID treatment strategies and outcomes in patients with differing risk characteristics is needed.

Can change in high-density lipoprotein cholesterol levels reduce cardiovascular risk?

BACKGROUND: The cardiovascular risk reduction observed in many trials of lipid-lowering agents is greater than expected on the basis of observed low-density lipoprotein cholesterol (LDL-C) level reductions. Our objective was to explore the degree to which high-density lipoprotein cholesterol (HDL-C) level changes explain cardiovascular risk reduction. METHODS: A systematic review identified trials of lipid-lowering agents reporting changes in HDL-C and LDL-C levels and the incidence of coronary heart disease (CHD). The observed relative risk reduction (RRR) in CHD morbidity and mortality rates was calculated. The expected RRR, given the treatment effect on total cholesterol level, was calculated for each trial with logistic regression coefficients from observational studies. The difference between observed and expected RRR was plotted against the change in HDL-C level, and a least-squares regression line was calculated. RESULTS: Fifty-one trials were identified. Nineteen statin trials addressed the association of HDL-C with CHD. Limited numbers of trials of other therapies precluded additional analyses. Among statin trials, therapy reduced total cholesterol levels as much as 32% and LDL-C levels as much as 45%. HDL-C level increases were <10%. Treatment effect on HDL-C levels was not a significant linear predictor of the difference in observed and expected CHD mortality rates, although we observed a trend in this direction (P =.08). Similarly, HDL-C effect was not a significant linear predictor of the difference between observed and expected RRRs for CHD morbidity (P =.20). CONCLUSIONS: Although a linear trend toward greater risk reduction was observed with greater effects on HDL-C, differences were not statistically significant. The narrow range of HDL-C level increases in the statin trials likely reduced our ability to detect a beneficial HDL-C effect, if present.

The contemporary management of prostate cancer in the United States: lessons from the cancer of the prostate strategic urologic research endeavor (CapSURE), a national disease registry.

PURPOSE: The epidemiology and treatment of prostate cancer have changed dramatically in the prostate specific antigen era. A large disease registry facilitates the longitudinal observation of trends in disease presentation, management and outcomes. MATERIALS AND METHODS: The Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a national disease registry of more than 10000 men with prostate cancer accrued at 31 primarily community based sites across the United States. Demographic, clinical, quality of life and resource use variables are collected on each patient. We reviewed key findings from the data base in the last 8 years in the areas of disease management trends, and oncological and quality of life outcomes. RESULTS: Prostate cancer is increasingly diagnosed with low risk clinical characteristics. With time patients have become less likely to receive pretreatment imaging tests, less likely to pursue watchful waiting and more likely to receive brachytherapy or hormonal therapy. Relatively few patients treated with radical prostatectomy in the database are under graded or under staged before surgery, whereas the surgical margin rate is comparable to that in academic series. CaPSURE data confirm the usefulness of percent positive biopsies in risk assessment and they have further been used to validate multiple preoperative nomograms. CaPSURE results strongly affirm the necessity of patient reported quality of life assessment. Multiple studies have compared the quality of life impact of various treatment options, particularly in terms of urinary and sexual function, and bother. CONCLUSIONS: The presentation and management of prostate cancer have changed substantially in the last decade. CaPSURE will continue to track these trends as well as oncological and quality of life outcomes, and will continue to be an invaluable resource for the study of prostate cancer at the national level.

Risk of Upper Gastrointestinal Injury and Events in Patients Treated With Cyclooxygenase (COX)-1/COX-2 Nonsteroidal Antiinflammatory Drugs (NSAIDs), COX-2 Selective NSAIDs, and Gastroprotective Cotherapy: An Appraisal of the Literature.

Numerous studies using varying methodologies and outcome measures have examined the gastrointestinal risks of aspirin and nonaspirin nonsteroidal antiinflammatory drug (NSAID) use. Despite the large volume of literature, clarity regarding the key risk factors and their quantitative importance is lacking. We performed a comprehensive review of the literature to summarize the incidence of gastrointestinal injury in populations with varying risk characteristics using agents that inhibit both isoforms of cyclooxygenase and those that selectively inhibit only cyclooxygenase-2 (COX-2).Although risk estimates vary, the risk of serious gastrointestinal complications in NSAID users is approximately 2.5 to 4.5 times that of nonusers. The risk of NSAID-related gastrointestinal bleeding is augmented by concomitant low-dose aspirin and could approach double the risk of NSAID use alone. The preponderance of evidence shows that the risk of NSAID-related gastrointestinal bleeding is reduced approximately 50% with a coxib as compared with traditional NSAID. The relative risk of hospitalization resulting from upper gastrointestinal bleeding for patients treated with a nonselective NSAID was 4.4 (95% confidence interval [CI], 2.3-8.5) and 1.9 (95% CI, 1.0-3.5) when compared with celecoxib and rofecoxib, respectively. Aspirin increases the risk of NSAID-related gastrointestinal bleeding in patients taking COX-2 selective inhibitors, with odds ratios ranging from 5.8 to 7.7; however, it is unknown whether this risk is greater than the risk from aspirin alone. The risks from both traditional NSAIDs and COX-2 inhibitors are increased in the elderly, patients on anticoagulation, and patients with prior gastrointestinal events.Gastroprotective agents have been found to significantly reduce the risk for gastrointestinal injury in patients receiving NSAID therapy, especially those receiving concurrent low-dose cardioprotective doses of aspirin. Proton pump inhibitors (PPIs) and misoprostol both reduce the incidence of gastric and duodenal ulcers, as well as recurrence of ulcer complications in patients receiving NSAIDs. The relative risk for gastric ulcers ranged from 0.17 to 0.38, whereas for duodenal ulcers, the range was 0.11 to 0.28. Although misoprostol is slightly more effective in preventing gastric ulcers in these patients, PPIs are better tolerated. Although NSAIDs appear safe in "low-risk" populations, our review suggests that the use of gastroprotective cotherapy should be considered in patients at higher risk of NSAID-related upper gastrointestinal bleeding.

Chronic acid-related disorders are common and underinvestigated.

OBJECTIVES: The aims of this study were as follows: to establish the prevalence of chronic acid-related disorders in a managed care population; to describe these patients; and to examine rates of adherence to current guidelines for investigation of dyspepsia and peptic ulcer disease. METHODS: The design was a population-based cohort study. The sample was drawn from 216,720 adult (aged >18 yr) members of a managed care organization that had an electronic medical record linked to administrative and pharmacy databases. We included adults with continuous enrollment from July, 1998, to January, 2000, who were dispensed histamine-2 blockers or proton-pump inhibitors, or both, for > or =1 yr. Dispensing data, sociodemographic and clinical information, comorbidities, and investigations were collected and analyzed. RESULTS: The final cohort consisted of 5064 patients; 64% were aged > or =50 yr, 47% were male, and 11% were African American. The prevalence of chronic acid-related disorders was 2.3%. Gastroesophageal reflux disease (59%) was the most common condition, followed by dyspepsia (35% of cohort; 18% investigated by endoscopy). There were 917 dyspepsia patients > or =50 yr who had not been investigated by endoscopy (81% of dyspepsia patients in this age group). There were 97 patients with peptic ulcer disease who did not have a documented test for Helicobacter pylori (34% of patients with peptic ulcer disease). CONCLUSIONS: Chronic acid-related disorders are common in primary care, and many patients use acid suppressing medications on a long-term basis. Nevertheless, according to current practice guidelines, our patients were underinvestigated. Future guidelines should specifically address the management of patients who use acid suppressing medications on a chronic basis.

Effectiveness of disease management programs in depression: a systematic review.

OBJECTIVE: The authors systematically evaluated the published evidence to assess the effectiveness of disease management programs in depression. METHOD: English-language articles on depression were identified through a MEDLINE search for the period from January 1987 to June 2001. Two reviewers evaluated 16,952 published titles, identified 24 depression disease management programs that met explicit inclusion criteria, and extracted data on study characteristics, interventions used, and outcome measures. Pooled effect sizes were calculated by using a random-effects model. RESULTS: Pooled results for disease management program effects on symptoms of depression showed statistically significant improvements (effect size=0.33, N=24). Programs also had statistically significant effects on patients' satisfaction with treatment (effect size=0.51, N=6), patients' compliance with the recommended treatment regimen (effect size=0.36, N=7), and adequacy of prescribed treatment (effect size=0.44, N=11). One program with an explicit screening component showed significant improvement in the rate of detection of depression by primary care physicians (effect size=0.66); two other programs lacking a screening component showed small nonsignificant improvements in the detection rate (effect size=0.18). Disease management programs increased health care utilization (effect size=-0.10, N=8), treatment costs (effect size=-1.03, N=3), and hospitalization (effect size=-0.20, N=2). CONCLUSIONS: Disease management appears to improve the detection and care of patients with depression. Further research is needed to assess the cost-effectiveness of disease management in depression, and consideration should be given to more widespread implementation of these programs.

Examining the value and quality of health economic analyses: implications of utilizing the QHES.

OBJECTIVE: To examine the increasing use of health economic studies and practical implications of evaluating their quality utilizing the Quality of Health Economic Studies (QHES) instrument. METHODS: We first reviewed secondary references to examine ways in which health economic analyses are used in different health care settings, the manner in which these data are appraised and evaluated, and their relevance and value in decision making. The QHES, a new instrument designed to support fast, accurate initial assessments of study quality, was then introduced and validated. A case study was performed using the QHES to score the quality of 30 cost-effectiveness studies in gastroesophageal reflux disease (GERD) published since 1985. Areas where additional research could guide efforts to identify and enhance the use of higher-quality cost-effectiveness studies were suggested. RESULTS: Results from the published validation study of the QHES demonstrated the validity of this new instrument. The resulting QHES scores in the case study of GERD papers ranged from 43 to 91 with a mean of 63.6 (SD=14.7). Approximately 27% of the studies rated had scores less than 50, and 27% had scores above or equal to 75. All 30 studies made conclusions and recommendations and justified them based on their study results. Most studies used appropriate cost and health outcome measures. Very few studies stated the perspective of their analysis and reasons for its selection. The majority of the studies did not perform incremental analysis. CONCLUSION: An examination of the QHES validation study and the case study in GERD suggests that there is a rationale and potential utility to use a quality scoring system for cost-effectiveness studies. The QHES may play an important role in discriminating higher-quality cost-effectiveness information to enhance decision making. The QHES can also serve as a guideline for conducting and reporting future cost-effectiveness studies, as an aid in the editorial process, and for stratification in systematic reviews. Complex decisions regarding resource allocation rarely rely solely on economic considerations but do increasingly use health economic analyses. To the extent that such analyses are used, the QHES may help ensure that higher-quality analyses receive more analytic attention and greater weight in the decision-making process.

Longitudinal differences in disease specific quality of life in men with erectile dysfunction: results from the Exploratory Comprehensive Evaluation of Erectile Dysfunction study.

PURPOSE: We assessed the impact of erectile dysfunction therapy on 1-year health related quality of life using a validated erectile dysfunction specific instrument. MATERIALS AND METHODS: Using an observational erectile dysfunction registry clinical, sociodemographic and health related quality of life information was collected at baseline, and 3, 6 and 12 months later. Only men who reported undergoing erectile dysfunction treatment were included in this analysis sub-sample. Patients were classified as treatment responders based on improvements in International Index of Erectile Function scores. Changes in health related quality of life scores from baseline were compared between responders and nonresponders. RESULTS: The cohort consisted of 89 patients, of whom 40 (45%) responded to therapy by International Index of Erectile Function criteria. Responders and nonresponders had comparable baseline disease severity and health related quality of life. At 1 year responders reported significantly better health related quality of life and greater improvement from baseline in sexual experience (mean change -1.64 versus 3.19) and emotional life (mean -3.01 for responders versus 1.75) domains of the Psychological Impact of Erectile Dysfunction scales (p <0.01). This 4.5 to 5 point difference in mean change score (1/2 SD) was considered moderately clinically significant. CONCLUSIONS: Men who respond to erectile dysfunction treatment report significantly better health related quality of life 1 year after initial presentation for erectile dysfunction than nonresponders. This finding should motivate providers to be more proactive in diagnosing and treating men with erectile dysfunction since successful therapy appears to improve health related quality of life. These data suggest that men in whom primary therapy for erectile dysfunction fails should be offered secondary treatment because many men in this study in whom previous therapies failed reported improved health related quality of life when they began effective secondary treatment.

Is quality of life different for men with erectile dysfunction and prostate cancer compared to men with erectile dysfunction due to other causes? Results from the ExCEED data base.

PURPOSE: To our knowledge the relationship between the underlying etiology of erectile dysfunction and its impact on health related quality of life has not been studied. Such a study is important for men with prostate cancer, as the potential negative quality of life impact of erectile dysfunction may affect clinical decision making in newly diagnosed disease. We compare health related quality of life in impotent men with prostate cancer to that of impotent men without prostate cancer using the Exploratory and Comprehensive Evaluation of Erectile Dysfunction (ExCEED, TAP Pharmaceutical Products, Inc., Lake Forest, Illinois) data base, which is a multicenter, observational disease registry of men with erectile dysfunction. MATERIALS AND METHODS: The cohort included 168 men in ExCEED who had baseline health related quality of life measurement. Of these men 47 reported a history of prostate cancer while 121 did not. Appropriate univariate and multivariate analyses were performed comparing health related quality of life outcomes between impotent men with and without prostate cancer. RESULTS: Men with erectile dysfunction and prostate cancer had worse sexual self-efficacy, erectile function, intercourse satisfaction and orgasmic function than those with erectile dysfunction without prostate cancer (all p <0.001). However, men with erectile dysfunction and prostate cancer experienced less psychological impact of erectile dysfunction on sexual experience (p = 0.05) and emotional life (p = 0.03) than those with erectile dysfunction without prostate cancer. The findings regarding the psychological impact of erectile dysfunction persisted in multivariate linear regression models. CONCLUSIONS: Men with erectile dysfunction and prostate cancer appear to have better disease specific health related quality of life than those with erectile dysfunction and no history of prostate cancer. This finding has important ramifications for clinicians when counseling patients newly diagnosed with prostate cancer and also when treating patients who present with erectile dysfunction of various etiologies.

Do impotent men with diabetes have more severe erectile dysfunction and worse quality of life than the general population of impotent patients? Results from the Exploratory Comprehensive Evaluation of Erectile Dysfunction (ExCEED) database.

OBJECTIVE: Little is known regarding how diabetic men with erectile dysfunction (ED) differ from the general population of impotent men. The primary objective of this study was to compare disease-specific health-related quality of life (HRQOL) and severity of ED in impotent men with and without diabetes. RESEARCH DESIGN AND METHODS: Validated functional and HRQOL questionnaires (including the International Index of Erectile Function, the Sexual Self-Efficacy Scale, and the Psychological Impact of Erectile Dysfunction scales) were administered to patients in an ED disease registry. Men with ED and a history of diabetes (n = 20) were compared with men with ED and no history of diabetes (n = 90) at baseline and at the 12-month follow-up. RESULTS: Diabetic impotent men reported worse erectile function and intercourse satisfaction at baseline, and ED had a greater impact on their emotional life. Diabetic men with ED had significantly different trends over time in the Erectile Function (P < 0.001), Intercourse Satisfaction (P < 0.013), Sexual Desire (P < 0.016), Overall Satisfaction (P < 0.023), and the Sexual Experience-Psychological Impact domains (P < 0.002). In addition, there was a trend toward a difference over time in the Emotional Life-Psychological Impact domain (P < 0.067). CONCLUSIONS: Impotent men with diabetes present with worse ED than nondiabetic men with ED, resulting in worse disease-specific HRQOL in the diabetic men. Although diabetic patients initially respond well to ED treatment, responses do not appear to be durable over time. Therefore, clinicians must provide longer-term follow-up when treating ED in diabetic patients.

Physician attitudes toward strategies to promote the adoption of medical evidence into clinical practice.

BACKGROUND: [corrected] Promoting the adoption of medical evidence into clinical practice has been advocated as one approach to improving healthcare quality and reducing medical errors. Data describing the effectiveness of different strategies to achieve this goal in real-world settings are limited. OBJECTIVE: To determine the effectiveness of selected interventions on the adoption of medical evidence into clinical practice. STUDY DESIGN: A cross-sectional survey of a random sample of physicians selected from the American Medical Association's Physician Master File. PATIENTS AND METHODS: We examined the perceived effectiveness of 7 strategies (represented by 27 individual interventions) and 5 general approaches for promoting the adoption of medical evidence into clinical practice in 1100 practicing physicians. Respondent exposure to interventions was also determined. Regression analyses were performed to identify factors that affected effectiveness ratings. Analysis of variance was used to test the hypothesis of equal mean scores across different comparison groups. RESULTS: Of 1,100 surveys mailed, 63 (5.7%) were excluded and 431 were completed (response rate = 41.6%). Mean +/- SD effectiveness scores for the 27 individual interventions on a 5-point Likert scale ranged from 2.0 +/- 0.9 (literature received from insurance companies and managed care organizations) to 4.2 +/- 0.8 (one-on-one communication with respected colleagues). Ranges for the 7 strategies were 2.6 +/- 1.0 (patient-mediated interventions) to 3.6 +/- 0.9 (educational meetings) and for the 5 general approaches were 1.98 +/- 0.9 (administrative interventions) to 3.3 +/- 0.8 (provider education). The hypothesis of equal mean effectiveness scores was rejected for all comparisons (P < .001). Frequency of exposure was the only variable to predict effectiveness (P < .001 for all regression models). CONCLUSION: From the perspective of practicing physicians, the frequency of exposure to strategies for promoting the adoption of medical evidence into clinical practice strongly affects their perceived effectiveness.

Development and validation of a grading system for the quality of cost-effectiveness studies.

PURPOSE: To provide a practical quantitative tool for appraising the quality of cost-effectiveness (CE) studies. METHODS: A committee comprising [corrected] of health economists selected a set of criteria for the instrument from an item pool. Data collected with a conjoint analysis survey on 120 international health economists were used to estimate weights for each criterion with a random effects regression model. To validate the grading system, a survey was sent to 60 individuals with health economics expertise. Participants first rated the quality of three CE studies on a visual analogue scale, and then evaluated each study using the grading system. Spearman rho and Wilcoxon tests were used to detect convergent validity and analysis of covariance (ANCOVA) for discriminant validity. Agreement between the global rating by experts and the grading system was also examined. RESULTS: Sixteen criteria were selected. Their coefficient estimates ranged from 1.2 to 8.9, with a sum of 93.5 on a 100-point scale. The only insignificant criterion was "use of subgroup analyses." Both convergent validity and discriminant validity of the grading system were shown by the results of the Spearman rho (correlation coefficient = 0.78, P < 0.0001), Wilcoxon test (P = 0.53), and ANCOVA (F(3,146) = 5.97, p = 0.001). The grading system had good agreement with global rating by experts. CONCLUSIONS: The instrument appears to be simple, internally consistent, and valid for measuring the perceived quality of CE studies. Applicability for use in clinical and resource allocation decision-making deserves further study.

Interventions used in disease management programmes for patients with chronic illness-which ones work? Meta-analysis of published reports.

OBJECTIVE: To systematically evaluate the published evidence regarding the characteristics and effectiveness of disease management programmes. DESIGN: Meta-analysis. DATA SOURCES: Computerised databases for English language articles during 1987-2001. STUDY SELECTION: 102 articles evaluating 118 disease management programmes. MAIN OUTCOME MEASURES: Pooled effect sizes calculated with a random effects model. RESULTS: Patient education was the most commonly used intervention (92/118 programmes), followed by education of healthcare providers (47/118) and provider feedback (32/118). Most programmes (70/118) used more than one intervention. Provider education, feedback, and reminders were associated with significant improvements in provider adherence to guidelines (effect sizes (95% confidence intervals) 0.44 (0.19 to 0.68), 0.61 (0.28 to 0.93), and 0.52 (0.35 to 0.69) respectively) and with significant improvements in patient disease control (effect sizes 0.35 (0.19 to 0.51), 0.17 (0.10 to 0.25), and 0.22 (0.1 to 0.37) respectively). Patient education, reminders, and financial incentives were all associated with improvements in patient disease control (effect sizes 0.24 (0.07 to 0.40), 0.27 (0.17 to 0.36), and 0.40 (0.26 to 0.54) respectively). CONCLUSIONS: All studied interventions were associated with improvements in provider adherence to practice guidelines and disease control. The type and number of interventions varied greatly, and future studies should directly compare different types of intervention to find the most effective.

Psychological impact of erectile dysfunction: validation of a new health related quality of life measure for patients with erectile dysfunction.

PURPOSE: Male erectile dysfunction has a substantial impact on health related quality of life. We examined the psychometric properties of 2 new scales created to measure the psychological impact of erectile dysfunction. MATERIALS AND METHODS: Patients enrolled in a long-term study of men with erectile dysfunction completed clinical and health related quality of life information at baseline and at 3 followup points. The questionnaire incorporated a number of standard scales of psychosocial characteristics as well as questions developed from comments made during focus groups of men with erectile dysfunction and of their female partners. Principal components analysis was used to identify underlying constructs in response to the new questions. RESULTS: A total of 168 men completed the baseline quality of life questionnaire. The principal components analysis of the psychological impact of erectile dysfunction questions resulted in 2 new scales. Reliability was good with an internal consistency reliability of 0.91 for scale 1 and 0.72 for scale 2. Test-retest reliability was 0.76 and 0.66, respectively. Men reporting a greater psychological impact of erectile dysfunction also reported greater impairment in functional status, lower sexual self-efficacy, greater depression and anxiety at the last intercourse. Each new scale significantly differentiated men with mild/moderate versus severe erectile dysfunction. CONCLUSIONS: We developed 2 new scales to measure the psychological impact of erectile dysfunction and they showed good reliability and validity. These new scales, named the Psychological Impact of Erectile Dysfunction instrument, comprehensively capture the psychological effect of erectile dysfunction on health related quality of life, which is not adequately assessed by existing patient centered measures of erectile function.

Mental health in men treated for early stage prostate carcinoma: a posttreatment, longitudinal quality of life analysis from the Cancer of the Prostate Strategic Urologic Research Endeavor.

BACKGROUND: The current study was conducted to assess posttreatment changes in the mental components of health related quality of life in prostate carcinoma patients during the two years following diagnosis and management with radical prostatectomy, pelvic irradiation, or watchful waiting. METHODS: The authors studied the mental domains of general health related quality of life in 452 men recently diagnosed with early stage prostate carcinoma and treated with radical prostatectomy, pelvic radiation, or watchful waiting. Outcomes were assessed with the RAND 36-Item Health Survey, a validated health-related quality of life instrument that includes four mental domains. To minimize the influence of potentially confounding factors, the authors adjusted for age, comorbidity, prostate specific antigen (PSA) at diagnosis, and biopsy Gleason score. All subjects were drawn from CaPSURE, a national, longitudinal cohort. RESULTS: By 6-12 months after treatment, the active treatment groups began to show differences in mental health and vitality. By 15 months, surgery and radiation patients scored differently in all four mental domains. Over time, the gaps between mental domain scores grew wider among the treatment groups, with surgery patients performing the best, radiation patients performing the worst, and watchful waiting patients falling in between. CONCLUSIONS: The mental health profiles differ for patients undergoing surgery, radiation, or watchful waiting for early stage prostate carcinoma. Men with more serious disease, as evidenced by higher PSA levels or more aggressive histology, tended to worry more about it. Older men performed better, while sicker men performed worse, even though the older men tended to be sicker.

The limited incorporation of economic analyses in clinical practice guidelines.

BACKGROUND: Because there is increasing concern that economic data are not used in the clinical guideline development process, our objective was to evaluate the extent to which economic analyses are incorporated in guideline development. METHODS: We searched medline and HealthSTAR databases to identify English-language clinical practice guidelines (1996-1999) and economic analyses (1990-1998). Additional guidelines were obtained from The National Guidelines Clearinghouse Internet site available at http://www.guideline.gov. Eligible guidelines met the Institute of Medicine definition and addressed a topic included in an economic analysis. Eligible economic analyses assessed interventions addressed in a guideline and predated the guideline by 1 or more years. Economic analyses were defined as incorporated in guideline development if 1) the economic analysis or the results were mentioned in the text or 2) listed as a reference. The quality of economic analyses was assessed using a structured scoring system. RESULTS: Using guidelines as the unit of analysis, 9 of 35 (26%) incorporated at least 1 economic analysis of above-average quality in the text and 11 of 35 (31%) incorporated at least 1 in the references. Using economic analyses as the unit of analysis, 63 economic analyses of above-average quality had opportunities for incorporation in 198 instances across the 35 guidelines. Economic analyses were incorporated in the text in 13 of 198 instances (7%) and in the references in 18 of 198 instances (9%). CONCLUSIONS: Rigorous economic analyses may be infrequently incorporated in the development of clinical practice guidelines. A systematic approach to guideline development should be used to ensure the consideration of economic analyses so that recommendations from guidelines may impact both the quality of care and the efficient allocation of resources.

Variations in use of imaging in a national sample of men with early-stage prostate cancer.

OBJECTIVES: To measure the national practice variations in imaging studies performed for men newly diagnosed with clinically localized prostate cancer. METHODS: We created an analytic file from 1991 to 1996 Medicare claims data using files for a random sample of 5% of all Medicare beneficiaries. Among men with newly diagnosed clinically localized prostate cancer, we identified those undergoing staging bone scans, staging computed tomography (CT), or staging magnetic resonance imaging (MRI) at the time of diagnosis. We conducted univariate and multivariate analyses adjusting for Charlson index score, age group, race, geographic region, and year of diagnosis. RESULTS: In all geographic regions, men receiving radiation therapy (RT) were more likely than those receiving radical prostatectomy (RP) to undergo CT. In the South, RT patients were significantly more likely than RP patients to undergo MRI and bone scans. In the West, RT patients were significantly more likely than RP patients to have bone scans. In multivariate analyses that controlled for all significant univariate findings, treatment with RT significantly predicted for the use of bone scans (odds ratio 1.24, 95% confidence interval 1.17 to 1.31), CT scans (odds ratio 3.26, 95% confidence interval 3.18 to 3.34), and MRI scans (odds ratio 1.47, 95% confidence interval 1.23 to 1.72). Regional differences in the use of imaging technologies for staging persisted in the multivariate analysis. CONCLUSIONS: Patients undergoing RT for clinically localized prostate cancer undergo more bone, CT, and MRI scans than do patients undergoing RP, regardless of comorbidity, age, or race. In addition, a significant geographic variation was found in the use of these diagnostic tests. These variations suggest that evidence-based staging guidelines have not been met with broad physician acceptance.