Controlled trial of interventions to increase testing and treatment for Helicobacter pylori and reduce medication use in patients with chronic acid-related symptoms.

BACKGROUND: Many symptomatic patients take proton pump inhibitors or histamine-2 blockers for years and those without gastro-oesophageal reflux disease might benefit from Helicobacter pylori eradication. AIM: To increase testing and treatment of H. pylori and reduce chronic use of proton pump inhibitors and histamine-2 blockers. METHODS: We conducted a three-armed controlled trial in 14 managed care practices. We included adults who used proton pump inhibitors or histamine-2 blockers for >1 year and excluded those with gastro-oesophageal reflux disease or previous endoscopy. We compared usual care (n = 312 patients from 6 practices) to low-intensity (n = 147 from 3 practices) and high-intensity (n = 122 from 5 practices) interventions. Low-intensity intervention consisted of guidelines, patient-lists, and a "toolkit"; high-intensity intervention added academic group detailing by a gastroenterologist with reinforcement by pharmacists. RESULTS: Compared with usual care, the high-intensity intervention increased H. pylori test-ordering (29% versus 9% at 12 months, P = 0.02). About half (23 of 58) of patients tested positive and 22 received eradication treatments. The high-intensity intervention decreased proton pump inhibitor use by 9% per year (P = 0.028), but did not alter histamine-2 blocker use. The low intensity intervention was ineffective. CONCLUSIONS: Providing guidelines, patient-lists, and toolkits was no better than usual care. Adding group detailing and pharmacist reinforcements led to improvements in H. pylori management and decreases in proton pump inhibitor use.

Guidelines for the appropriate use of non-steroidal anti-inflammatory drugs, cyclo-oxygenase-2-specific inhibitors and proton pump inhibitors in patients requiring chronic anti-inflammatory therapy.

AIM: To rationalize decision making around the use of different non-steroidal anti-inflammatory drug (NSAID) treatment strategies in patients with varying degrees of gastrointestinal and cardiovascular risk. METHODS: The panel comprised nine physicians (three rheumatologists, two internists, two gastroenterologists and two cardiologists) from geographically diverse areas practising in community-based settings (n = 4) and academic institutions (n = 5). A literature review was performed by the authors on the risks, benefits and costs of NSAIDs, cyclo-oxygenase-2-specific inhibitors and proton pump inhibitor co-therapy. The RAND/UCLA Appropriateness Method was used to rate 304 clinical scenarios as 'appropriate', 'uncertain' or 'inappropriate'. RESULTS: In patients with no previous gastrointestinal event and not concurrently on aspirin (low risk), the panel rated the use of an NSAID alone as 'appropriate' for those aged < 65 years, and the use of an NSAID +proton pump inhibitor or cyclo-oxygenase-2-specific inhibitor + proton pump inhibitor as 'inappropriate'. For patients aged > 65 years and at low risk, an NSAID or cyclo-oxygenase-2-specific inhibitor alone was rated as 'uncertain'. For patients with a previous gastrointestinal event or who concurrently received aspirin, an NSAID alone was rated as 'inappropriate', and either a cyclo-oxygenase-2-specific inhibitor or an NSAID +proton pump inhibitor was rated as 'appropriate'. Finally, for patients with a previous gastrointestinal event and on aspirin, an NSAID or cyclo-oxygenase-2-specific inhibitor in conjunction with a proton pump inhibitor was rated as 'appropriate'. CONCLUSIONS: Clinicians and managed care entities need to balance the risks, benefits and costs of NSAIDs, cyclo-oxygenase-2-specific inhibitors and the prophylactic use of proton pump inhibitors. The guidelines given here can assist this process.

Health-related quality of life in men with metastatic prostate cancer: the misleading effect of lead-time bias.

OBJECTIVE: To ascertain whether the difference in health-related quality of life, which appears to be worse in men with metastatic prostate cancer when the metastases are noted at initial diagnosis than during follow-up after treatment for clinically localized disease, can be attributed to previous local control or to some form of measurement bias. PATIENTS AND METHODS: We analysed by univariate and multivariate methods 375 men with metastatic prostate cancer who were enrolled in CaPSURE, a national observational cohort of patients with prostate cancer treated in community and academic settings throughout the USA. In particular, we assessed whether group differences in health-related quality of life were explained by the timing of metastatic diagnosis in the course of their disease. Health-related quality of life was measured with the RAND 36-Item Health Survey (SF-36). RESULTS: After controlling for relevant covariates (age, comorbidity and ethnicity), multivariate models suggested that men whose metastases were noted at the time of initial diagnosis scored 5-15 points worse in all eight domains of the SF-36. CONCLUSION: Men who are diagnosed with metastatic prostate cancer during the follow-up after treatment for clinically localized disease report a better quality of life than those who are metastatic at the time of diagnosis, not because the primary treatment confers any benefit but because they are followed more closely over time and diagnosed with metastases earlier in the course of their disease. This apparent difference in quality of life is an effect of lead-time bias in the diagnosis of metastasis.

Health-Related quality-of-life and quality-days incrementally gained in symptomatic nonerosive GERD patients treated with lansoprazole or ranitidine.

Eight-hundred forty-nine patients with symptomatic nonerosive GERD from two clinical trials of lansoprazole 15 mg daily (LAN 15) and lansoprazole 30 mg daily (LAN 30) vs ranitidine 150 mg twice a day (RAN 150) completed a health-related quality-of-life (HRQoL) questionnaire at baseline and four and eight weeks after treatment. The questionnaire included the Short-Form 12, GERD symptoms, eating symptoms, social restrictions, problems with sleep, work disability, treatment satisfaction, and associated importance weights items. Both LAN groups reported greater, although not significant, improvement from baseline to week 8 versus RAN 150 in the majority of HRQoL scales. Treatment satisfaction was significantly higher at week 8 in both LAN groups. Quality-days incrementally gained analysis showed that both LAN groups gained significantly more quality days than RAN 150. Patients taking lansoprazole 15 or 30 mg daily reported better outcomes than those receiving ranitidine 150 twice a day over the eight-week study.

Management of heartburn in a large, randomized, community-based study: comparison of four therapeutic strategies.

OBJECTIVE: Our objective was to compare four management strategies for heartburn: therapy with an H2-receptor antagonist (ranitidine), therapy with a proton pump inhibitor (lansoprazole), crossover from ranitidine to lansoprazole ("step-up" therapy), and crossover from lansoprazole to ranitidine ("step-down" therapy). METHODS: This was a controlled, double-blind, multicenter trial comprising 593 adults with heartburn, randomized to one of four groups for 20 wk. Subjects received either ranitidine 150 mg b.i.d. for 20 wk, or lansoprazole 30 mg once daily for 20 wk, or ranitidine 150 mg b.i.d. for 8 wk [corrected] followed by lansoprazole 30 mg once daily for 12 wk ("step-up"), or lansoprazole 30 mg once daily for 8 wk followed by ranitidine 150 mg b.i.d. for 12 wk ("step-down"). Outcome measures were based on self-reports in daily diaries of 24-h heartburn severity, measured by maximum daytime and nighttime severity, and percentage of 24-h heartburn-free days measured by absence of both daytime and nighttime heartburn. RESULTS: Median heartburn severity was significantly lower (p < 0.05) for lansoprazole (0.25) than the other groups (0.46 ranitidine, 0.44 "step-up," 0.35 "step-down"). The lansoprazole group had a significantly higher percentage of 24-h heartburn-free days (median 81.4%, p < 0.01) than other groups (66.6, 66.9, and 73.6%, respectively). In the "step-up" and "step-down" groups, heartburn was less severe, and percentages of 24-h heartburn-free days were higher during lansoprazole treatment regardless of treatment sequence. CONCLUSION: Proton pump inhibitor treatment provides more consistent heartburn relief than an H2-receptor antagonist, or "step-up" or "step-down" therapy.

Racial differences in the cost of treating men with early-stage prostate cancer.

OBJECTIVE: To compare the cost and resource utilization in the evaluation, treatment, and 6-month follow-up of African-American and White men undergoing either external beam radiation therapy (XRT) or radical prostatectomy (RP) for early-stage prostate cancer. DESIGN: Retrospective analysis of cost and resource utilization data from encrypted patient-specific hospital inpatient, hospital outpatient, and physician/supplier data files. SETTING: National Medicare claims data from 1993 through 1996. PARTICIPANTS: A random 5% national sample of Medicare beneficiaries from the Health Care Financing Administration Public Use Files for 1993 through 1996. MEASUREMENTS: Inpatient, outpatient, and physician/supplier Medicare costs. RESULTS: African-American men undergoing RP for early-stage prostate cancer had significantly higher costs ($21,878 vs $18,786, P < .0001) than did White men. Most of the difference occurred in the inpatient setting. African-American men undergoing XRT had significantly greater costs ($18,131 vs $15,734, P < .0001) than did White men. Most of this difference was generated by longer duration of XRT treatments. CONCLUSIONS: In early-stage prostate cancer, charges for RP and XRT in African-American men are higher when compared with those for White men.

Early switch and early discharge strategies in patients with community-acquired pneumonia: a meta-analysis.

BACKGROUND: The effectiveness of early switch and early discharge strategies in patients with community-acquired pneumonia remains unknown. METHODS: We searched the MEDLINE, HEALTHSTAR, EMBASE, Cochrane Collaboration, and Best Evidence databases from January 1, 1980, to March 31, 2000, for community-acquired pneumonia studies that included specific switch criteria or recommendations to switch on a particular day. RESULTS: From 1794 titles identified, 121 articles were reviewed. We identified 10 prospective, interventional, community-acquired pneumonia-specific studies that evaluated length of stay (LOS). Nine studies applied an early switch from parenteral to oral antibiotic criteria. Six different criteria for switching were applied in the 9 studies. Five of the studies that applied early switch criteria also applied separate criteria for early discharge. Six studies applied an early switch and early discharge strategy to an intervention and control group, and 5 of these provided SD values for LOS. The mean change in LOS was not significantly (P =.05) reduced in studies of early switch and early discharge (-1.64 days; 95% confidence interval, -3.30 to 0.02 days). However, when the 2 studies in which the recommended LOS was longer than the control LOS were excluded from the analysis, the mean change in LOS was reduced by 3 days (-3.04 days; 95% confidence interval, -4.90 to -1.19 days). Studies did not reveal significant differences in clinical outcomes between the intervention and control groups. CONCLUSIONS: There is considerable variability in early switch from parenteral to oral antibiotic criteria for patients with community-acquired pneumonia. Early switch and early discharge strategies may significantly and safely reduce the mean LOS when the recommended LOS is shorter than the actual LOS.

Quality of life before death for men with prostate cancer: results from the CaPSURE database.

PURPOSE: We examined changes in health related quality of life during the 12 months before death in men with prostate cancer. MATERIALS AND METHODS: We studied patients from CapSure, which is a longitudinal observational cohort of men with biopsy proved prostate cancer treated in community and academic urology practices across the United States. Of all men in the cohort who died while being followed for prostate cancer 131 who had submitted health related quality of life surveys during the 6 months before death were included in this analysis. Health related quality of life was measured with the RAND 36-Item Health Survey, an established validated instrument that comprises 4 physical and 4 mental domains. RESULTS: On univariate analysis all 8 domains of the 36-Item Health Survey substantially decreased in the final year of life. On multivariate analysis only physical function decreased more rapidly in men dying of prostate cancer compared to those dying of other cancer or benign causes. CONCLUSIONS: Quality of life begins a steady and inexorable decline in the final 12 months of life in men with prostate cancer. Increased attention to quality of life changes may provide new clinical opportunities to enhance quality of care in the final year of life in these men.

A nationwide charge comparison of the principal treatments for early stage prostate carcinoma.

BACKGROUND: The diagnosis and treatment of men with early stage prostate carcinoma is expensive and controversial, yet the similarities in reported survival rates has underscored the importance of ascertaining the relative charges of different forms of therapy. METHODS: Patient specific data on demographic characteristics, hospital and physician resource use, and charges were obtained from the Health Care Financing Administration for 1993 through 1996. The inpatient, outpatient, and part B claims from men with a new diagnosis of prostate carcinoma were captured from the quarter of the year in which biopsy was performed through the two quarters after treatment. Charges are reported in inflation-unadjusted dollars. RESULTS: Of 10,107 men treated for early stage prostate carcinoma, 58% received external beam radiation therapy (XRT), 35% had radical prostatectomy, and 7% underwent brachytherapy. Over the 4 years, use of XRT decreased 19% whereas use of brachytherapy increased 21%. Men aged 65-69 years were more likely to have radical prostatectomy, but after age 70 years, XRT predominated. The most expensive treatments were radical prostatectomy with adjuvant XRT ($31,329) and brachytherapy with pretreatment XRT ($24,407). Cost of radical prostatectomy alone was more than XRT alone ($19,019 vs. 15,937; P < 0.05) or brachytherapy alone ($15,301; P < 0.05). Treatment utilization varied with age, race, and geographic region. CONCLUSIONS: The mean charges for the workup, treatment, and 6 month follow-up of patients treated for early stage prostate carcinoma ranged between $15,301 and $31,329, with significant treatment group differences. Without a clear survival advantage from one form of treatment, issues such as costs, quality of life, and patient preferences take on paramount importance.

An instrument to measure patient satisfaction with healthcare in an observational database: results of a validation study using data from CaPSURE.

OBJECTIVE: To validate a satisfaction measure for use in longitudinal, prospective studies of patient care. STUDY DESIGN: Patients with biopsy-confirmed prostate cancer (n = 228) who were enrolled in CaPSURE (Cancer of the Prostate Strategic Urologic Research Endeavor) completed a self-administered questionnaire that included a health-related quality-of-life and satisfaction measure. A subset of patients completed the questionnaire again within 30 days. METHODS: The satisfaction measure contained 6 individual subscales: overall satisfaction with care, contact with providers, confidence in providers, communication skills, humaneness, and a summary scale. Six items surveyed patients' willingness to participate in decision making (participatory style), and these were averaged into a single score. Variability, reliability, stability, and validity were evaluated. RESULTS: Responses to the items varied substantially. The overall satisfaction scale demonstrated good internal consistency reliability (Cronbach alpha = 0.82) and moderate test-retest reliability (0.62), and it could discriminate between groups of individuals expected to differ with regard to satisfaction (by age and disease stage). Subscale internal consistency reliability (0.37-0.54) and stability (0.38-0.63) were weaker, suggesting that only a single scale should be reported. The participatory scale performed poorly and could not be recommended for future use. CONCLUSION: The overall satisfaction measure developed for this study demonstrated good reliability and validity and should be useful in other population-based studies in conjunction with other outcome measures.

Patterns of treatment of patients with prostate cancer initially managed with surveillance: results from The CaPSURE database. Cancer of the Prostate Strategic Urological Research Endeavor.

PURPOSE: We determined the demographic and clinical profile of men who elect surveillance as the initial management of prostate cancer as well as the incidence and predictors of secondary treatment of these patients. MATERIALS AND METHODS: The Cancer of the Prostate Strategic Urological Research Endeavor (CaPSURE) is a national disease registry of patients with various stages and treatments of prostate cancer. Using this database of 4,458 men we identified 329 (8.2%) who elected surveillance as the initial management of prostate cancer. Patients choosing watchful waiting were compared to other CaPSURE participants using the chi-square test. The likelihood of treatment initiation in the watchful waiting group was calculated using the Kaplan-Meier method. After adjusting for patient age, race, prostate specific antigen (PSA) at diagnosis, clinical T stage and total Gleason score the Cox proportional hazards regression model was used to determine significant predictors of treatment initiation. RESULTS: Compared with others in the database, patients on watchful waiting were more likely to be 75 years old or older (51% versus 16%, p <0.001), white (93% versus 85%, p <0.001), and have lower serum PSA (p <0.001), organ confined disease (97% versus 88%, p <0.001) and a total Gleason score of 7 or less (97% versus 88%, p <0.001). In the watchful waiting group there was a 52% likelihood of treatment initiation within 5 years of the diagnosis. Significant predictors of secondary treatment were age younger than 65 years and elevated serum PSA at diagnosis. Neither race, extraprostatic stage cT3 disease nor higher total Gleason score was a significant predictor of treatment. CONCLUSIONS: Men who elect initial watchful waiting for prostate cancer tend to be older, have lower serum PSA and more favorable disease characteristics than those who seek treatment. PSA at diagnosis is the dominant factor for predicting secondary treatment.

Work loss costs due to peptic ulcer disease and gastroesophageal reflux disease in a health maintenance organization.

OBJECTIVE: The aim of this study was to estimate the value of work time and productivity loss because of peptic ulcer disease (PUD) and gastroesophageal reflux disease (GERD). METHODS: A total of 300 adult members of Northern California Kaiser Permanente Medical Care Program with outpatient diagnoses of PUD or GERD were randomly selected for a record review to confirm diagnosis. A telephone survey was conducted soliciting information about work loss because of their disease. Reported work losses were valued at self-reported hourly wage to derive work loss costs. A total of 117 PUD and 102 GERD patients participated. RESULTS: About 75% of each sample was employed full-time or part-time. In all, 42% of potentially working PUD patients and 41% of GERD patients reported some lost work productivity because of their disease. The average loss (per person working) was $606 for PUD and $237 for GERD over a 3-month period. Reduced productivity while at work and part-time work because of the disease were the most costly productivity losses for PUD, whereas time off for physician visits and reduced productivity while at work were the most costly losses for GERD. CONCLUSIONS: Work loss costs for patients with PUD and GERD may be nearly as large as direct medical care costs, and are consistent with the more acute nature of PUD and the chronic pattern of GERD. The work losses resulting from these diseases are large enough to warrant consideration in guideline development and policy decisions for patients with PUD and GERD.

Impact of positive surgical margins on prostate cancer recurrence and the use of secondary cancer treatment: data from the CaPSURE database.

PURPOSE: We determined the impact of positive surgical margins on prostate specific antigen (PSA) recurrence and secondary treatment in patients who underwent radical prostatectomy as definitive local treatment for prostate cancer. MATERIALS AND METHODS: We reviewed the pathology reports of 1,383 patients in the CaPSURE database, a longitudinal disease registry of men with prostate cancer, who underwent radical prostatectomy as definitive local treatment. Pathological stage, Gleason score, and the number and location of any positive surgical margins were determined in each patient. PSA recurrence was defined as PSA 0.2 ng./ml. or greater on 2 consecutive occasions after radical prostatectomy. Secondary cancer treatment consisted of radiation or androgen deprivation after radical prostatectomy. Adjuvant and nonadjuvant secondary treatment was given within and more than 6 months after radical prostatectomy, respectively. Kaplan-Meier event rates of PSA recurrence and secondary treatment were calculated for patients with positive and negative surgical margins. We performed multivariate Cox proportional hazards analysis to adjust for clinical differences in groups. RESULTS: Patients with positive surgical margins were significantly more likely to undergo secondary adjuvant or nonadjuvant cancer treatment and have PSA recurrence than those with negative margins. After adjusting for patient age, ethnicity, PSA at diagnosis, pathological stage and Gleason score, surgical margin status was an important independent predictor of PSA recurrence and secondary treatment (p = 0.06 and 0.0011, respectively). The number of positive margins and positive margin location had little impact on the outcomes measured. CONCLUSIONS: These data indicate that surgical margin status is an independent predictor of PSA recurrence and secondary cancer treatment in patients who underwent radical prostatectomy as definitive local therapy for prostate cancer.

A comparison of patient and partner responses to a brief sexual function questionnaire.

PURPOSE: Patient self-administered questionnaires have recently been developed to assess sexual function in men with erectile dysfunction. However, it may also be important to assess satisfaction with and any improvements in sexual function from the perspective of the female partner. We report the results of a brief 3-item questionnaire developed for the female partner and its association with an 11-item questionnaire developed for men with erectile dysfunction. MATERIALS AND METHODS: Men and their female partners each self-administered a brief sexual function questionnaire several times during a clinical trial of an experimental treatment for erectile dysfunction. Items addressed the frequency and firmness of erection, and satisfaction with sex life on a 5-point Likert scale with responses ranging from 0 to 4. We compared mean values of the 3 items common to each questionnaire by respondent, and also analyzed item and scale correlations using weighted kappa statistics and/or the Pearson correlation coefficient. RESULTS: Data from 389 pairs were available. Generally patient results were fairly consistent with those of partners. Men reported slightly more frequent erection (1.6 versus 1.5), identical firmness of erection (1.2) and less satisfaction (1.2 versus 1.4) than partners. Weighted kappas of the 3 items ranged from 0.47 to 0.61, representing good agreement. The Pearson correlations were slightly higher. Internal consistency reliability using Cronbach's alpha of the 3-item scale was 0.69 (0.77 for patient and 0.81 for partner). CONCLUSIONS: These data support the use of patient and partner assessments of sexual function in clinical trials of erectile dysfunction.

A comparison of two approaches for assessing patient importance weights to conduct an Extended Q-TWiST analysis.

OBJECTIVE: Patient-centered methods for evaluating treatments require validated preference-elicitation techniques. We describe the validation of two preference-elicitation approaches for use in an Extended Q-TWiST treatment evaluation. The first method was an "idiographic" approach, which attempts to capture intra-individual differences in the degree to which each domain distracted from and interfered with life activities. The second method, a Likert-scaled approach, asks patients to evaluate the importance of each quality-of-life (QOL) domain. METHODS: Patient-reported QOL and preferences were assessed in participants with gastroesophageal reflux disease at baseline (n = 172), one week (n = 25), and 4 weeks after baseline (n = 100). RESULTS: Both approaches demonstrated high internal consistency and the ability to discriminate known groups based on reported pain and number of days with symptoms. The idiographic approach exhibited responsiveness, although it was more highly correlated with QOL than the Likert-scaled approach. The Likert-scaled approach had good face validity but demonstrated low reliability compared to the idiographic approach. CONCLUSIONS: Both preference-elicitation methods exhibited promise as well as limitations. Future research should focus on increasing the reliability of the Likert-scaled approach, reducing the overlap between the idiographic approach and QOL, and examining the relationship between reliability and responsiveness for a range of illness trajectories.

Quantifying comorbidity in a disease-specific cohort: adaptation of the total illness burden index to prostate cancer.

OBJECTIVES: Numerous studies have demonstrated the importance of comorbid illness when analyzing medical outcomes. The purpose of this study was to adapt a generic comorbidity index, the Total Illness Burden Index (TIBI), for use in men with prostate cancer, and to evaluate the usefulness of the new instrument in adjusting for the impact of comorbidity on functional outcomes in a prostate cancer cohort. METHODS: The TIBI uses patients' self-report of symptoms and diagnoses to determine not only the presence but also the severity of comorbidities in each of 16 body system domains. To create the TIBI-P (prostate cancer modification), some domains were added and others were modified according to clinical criteria. The TIBI-P was completed by 1638 men with prostate cancer followed up longitudinally in 29 urology practices in the United States. TIBI-P scores were calculated for each patient and analyzed with scores on the SF-36 quality-of-life questionnaire and with patient report of days confined to bed. RESULTS: After adjusting for age and income, lower SF-36 scale scores and increases in confinement to bed were associated with a greater burden of comorbid illness as measured by the TIBI-P, independent of the extent of prostate cancer. The TIBI-P explained 24% of the variance in the SF-36 physical functioning domain score. CONCLUSIONS: The TIBI-P is a powerful measure of the impact of comorbid illness on the quality of life and functioning among patients with prostate cancer. This index may prove valuable in research on clinical and economic outcomes of prostate cancer.

Sexual function and bother after radical prostatectomy or radiation for prostate cancer: multivariate quality-of-life analysis from CaPSURE. Cancer of the Prostate Strategic Urologic Research Endeavor.

OBJECTIVES: To measure the effect of treatment choice (pelvic irradiation [XRT] versus radical prostatectomy [RP] with or without nerve sparing) on sexual function and sexual bother during the first 2 years after treatment. METHODS: We studied sexual function and sexual bother in 438 men recently diagnosed with early-stage prostate cancer and treated with XRT or RP with or without nerve sparing. Outcomes were assessed with the University of California, Los Angeles Prostate Cancer Index, a validated health-related quality-of-life instrument that includes these two domains. To minimize the influence of other factors, we adjusted for age, comorbidity, general health, and previous treatment for erectile dysfunction. All subjects were drawn from CaPSURE, a national, longitudinal data base. RESULTS: Sexual function improved over time during the first year in all treatment groups; however, during the second year, sexual function began to decline in the XRT group. Older patients who received XRT showed substantial declines in sexual function throughout the 2 years, and older patients who underwent RP experienced a return of very low baseline sexual function. Sexual function was improved by the use of nerve-sparing procedures or erectile aids. Alterations in sexual bother were ameliorated by many factors, including age, general health perceptions, and sexual function. CONCLUSIONS: Patients undergoing XRT or RP with or without nerve sparing all showed comparable rates of improvement in sexual function during the first year after treatment for early-stage prostate cancer. However, in the second year after treatment, patients treated with XRT began to show declining sexual function; patients treated with RP did not.

Development of a health-related quality-of-life questionnaire for individuals with gastroesophageal reflux disease: a validation study.

This study was conducted to test the psychometric properties of a newly developed health-related quality-of-life (HRQoL) questionnaire. A total of 172 symptomatic GERD patients completed a 57-item questionnaire (containing the SF-12; symptom frequency/bothersomeness; problems related to activities, sleep, work disability; overall HRQoL; and treatment satisfaction) at baseline, week 1 [retest (N = 25)], and week 4 [follow-up (N = 100)]. Internal-consistency reliability was acceptable for most scales (range: 0.74-0.92). Test-retest reliability was acceptable for most scales (ICC: 0.74-0.85). Construct validity was demonstrated based on observed correlations. Known-groups validity was upheld, as patients who experienced more symptom days and patients who reported higher pain reported worse HRQoL than those with less symptoms or less severe pain. When categorized according to change in pain severity, Guyatt's statistic for the "improved" and "worse" groups demonstrated responsiveness, although many of the scales for the "stable" group were also responsive. In conclusion, the HRQoL questionnaire was found to be reliable, valid, and responsive.

Probabilistic sensitivity analysis incorporating the bootstrap: an example comparing treatments for the eradication of Helicobacter pylori.

Decision-analytic models are frequently used to evaluate the relative costs and benefits of alternative therapeutic strategies for health care. Various types of sensitivity analysis are used to evaluate the uncertainty inherent in the models. Although probabilistic sensitivity analysis is more difficult theoretically and computationally, the results can be much more powerful and useful than deterministic sensitivity analysis. The authors show how a Monte Carlo simulation can be implemented using standard software to perform a probabilistic sensitivity analysis incorporating the bootstrap. The method is applied to a decision-analytic model evaluating the cost-effectiveness of Helicobacter pylori eradication. The necessary steps are straightforward and are described in detail. The use of the bootstrap avoids certain difficulties encountered with theoretical distributions. The probabilistic sensitivity analysis provided insights into the decision-analytic model beyond the traditional base-case and deterministic sensitivity analyses and should become the standard method for assessing sensitivity.

Approaches to missing data inference results from CaPSURE: an observational study of patients with prostate cancer.

OBJECTIVE: There are multiple reasons for missing data in observational studies; excluding patients with missing data can lead to significant bias. In this study, we evaluated several methods for assigning missing values to health service utilisation. DESIGN AND SETTING: Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) is a US national database of men with prostate cancer. Physician visits and diagnostic tests for 342 patients newly diagnosed with prostate cancer were evaluated. PATIENTS AND PARTICIPANTS: Patients were followed for a full year (observed data, n = 228) and patients with incomplete data (predicted data, n = 114) were included. INTERVENTIONS: We used the following approaches for imputing missing data: assigning the group mean, a time-specific mean, a patient-specific mean, a stratified mean (by age, localised disease and insurance status) and carrying the last observation forward and/or backward. MAIN OUTCOME MEASURES AND RESULTS: All prediction strategies resulted in higher estimates (19.3 to 23.1) for annual physician visits than was observed (17.1 +/- 15.5), and differences were statistically significant for both the last observation carried forward (23.1 +/- 15.5) and the patient's individual mean (22.7 +/- 36.1) when predicting physician visits. The same strategies had higher predicted values for x-rays (1.8 +/- 5.1 and 1.8 +/- 4.4 vs 1.1 +/- 1.9 for the observed group), although the last observation carried forward was not statistically different from the observed value. CONCLUSIONS: We were unable to identify a single optimal strategy. However, imputation from individual means and the last observation carried forward methods did not perform as well as the other strategies. While the differences observed in this study were small, we anticipate that with increased length of follow-up and more dropouts, there would be greater differences among strategies.