Recent trends in the characteristics of patients prescribed sitagliptin and other oral antihyperglycaemic agents in a large U.S. claims database.

AIM: This study was designed to determine if differences in baseline characteristics of patients with type 2 diabetes mellitus (T2DM) being treated with sitagliptin vs. other oral antihyperglycaemic agents (OAHA) during the initial 2 years following sitagliptin's introduction in the U.S. continued during the second 2 years of sitagliptin availability. METHODS: Patients with T2DM and at least one new prescription for sitagliptin or another OAHA from Oct 2006 to April 2010 were identified in an insurance claims database. Multivariate logistic regression adjusting for age, gender, treatment type (monotherapy, dual or triple therapy), new or existing T2DM diagnosis, and comorbidities and diabetes complications in the prior 12 months was used to estimate odds ratios for sitagliptin vs. other OAHAs. RESULTS: During 2006-2007 or 2008-2010, new sitagliptin users were older and more likely to be male, have prior diagnosis of T2DM, or initiating combination therapy compared with new users of other OAHAs. Prevalence of comorbidities and complications was consistently higher for new sitagliptin users across most of the conditions assessed during both time periods. CONCLUSIONS: New sitagliptin users consistently tended to be older and have greater comorbidity/complication burden compared with new users of other OAHAs. These differences in baseline characteristics persisted up to 4 years postapproval. This observation has significant implications for observational studies using electronic medical record or insurance claims databases. Appropriate adjustment is needed to try to control for potential confounding and channelling bias resulting from this non-random prescribing pattern, and the limitations of such analyses acknowledged.

Risk of acute renal failure in patients with Type 2 diabetes mellitus.

AIMS: Progressive decline in renal function has been well described in patients with Type 2 diabetes mellitus, but few studies have assessed the risk of acute renal failure in a large population of patients with Type 2 diabetes. This study quantified the risk of acute renal failure associated with Type 2 diabetes in the General Practice Research Database from the UK. METHODS: Patients with Type 2 diabetes (n = 119,966) and patients without diabetes (n = 1,794,516) were identified in the General Practice Research Database. Patients with end-stage renal disease were excluded. Crude incidence and multivariate-adjusted hazard ratios of acute renal failure were estimated for patients with diabetes relative to those without diabetes. Cox regression models were adjusted for a variety of comorbidities. Increase of acute renal failure risk resulting from additive effects of specific co-morbidities with Type 2 diabetes was also assessed. RESULTS: Between 2003 and 2007, acute renal failure incidence was 198 per 100,000 person-years in patients with Type 2 diabetes compared with 27 per 100,000 patients-years among patients without diabetes (crude hazard ratio 8.0, 95% CI 7.4-8.7). Risk of acute renal failure for patients with Type 2 diabetes remained significant, but was attenuated in multivariate analyses adjusting for various comorbidities (adjusted hazard ratio 2.5, 95% CI 2.2-2.7). Age and specific comorbidities (chronic kidney disease, hypertension and congestive heart failure) were also associated with increased risk of acute renal failure in Type 2 diabetes. CONCLUSIONS: Patients with Type 2 diabetes have increased risk for acute renal failure compared with patients without diabetes, even after adjustment for known risk factors, particularly in the elderly and those with other comorbidities such as chronic kidney disease, congestive heart failure and hypertension.

Impact of diabetes duration and chronic pancreatitis on the association between type 2 diabetes and pancreatic cancer risk.

AIM: To examine the impact of diabetes duration, chronic pancreatitis and other factors on pancreatic cancer risk. METHODS: This retrospective cohort study using the UK General Practice Research Database compared pancreatic cancer incidence and risk in patients with type 2 diabetes mellitus (T2DM) versus patients without diabetes. Multivariate Cox regression adjusting for age, sex, history of chronic pancreatitis, gallbladder disease, obesity, smoking and alcohol use and Charlson comorbidity index was used to estimate hazard ratio (HR) [95% confidence interval, CI]. Analyses were repeated using various time windows for diabetes duration. RESULTS: A total of 1903 incident pancreatic cancers were identified, 436 in patients with T2DM (78.76 per 100 000 person-years [95% CI: 71.54, 86.51]) and 1467 in patients without diabetes (11.46 per 100 000 person-years [10.88, 12.06]). Pancreatic cancer risk was significant for T2DM (adjusted HR 1.80 [1.52, 2.14]), increasing age, history of chronic pancreatitis and tobacco use. For patients with chronic pancreatitis and T2DM, the adjusted HR was 12.12 [6.02, 24.40]. Incidence was highest in patients with ≥5 year duration of T2DM. In patient populations with duration of T2DM ranging from ≥1 to ≥5 years, adjusted HRs remained significant but point estimates attenuated slightly with longer duration of T2DM. CONCLUSIONS: Patients with T2DM had an 80% increased risk of pancreatic cancer versus patients without diabetes. Patients with T2DM and chronic pancreatitis were 12 times more likely to develop pancreatic cancer.

The Finnish Diabetes Risk Score is associated with insulin resistance but not reduced ß-cell function, by classical and model-based estimates.

AIMS: The Finnish Diabetes Risk Score (FINDRISC) is widely used for risk stratification in Type 2 diabetes prevention programmes. Estimates of ß-cell function vary widely in people without diabetes and reduced insulin secretion has been described in people at risk for diabetes. The aim of this analysis was to evaluate FINDRISC as a tool to characterize reduced ß-cell function in individuals without known diabetes. METHODS: In this population-based cohort from the Hoorn municipal registry, subjects received an oral glucose tolerance test and a meal tolerance test on separate days, in random order, within 2 weeks. One hundred and eighty-six subjects, age 41-66 years, with no known Type 2 diabetes were included. Of those, 163 (87.6%) had normal glucose metabolism and 23 (12.4%) had abnormal glucose metabolism (19 with impaired glucose metabolism; four with newly diagnosed Type 2 diabetes based on study results). Insulin sensitivity and ß-cell function (classical: insulinogenic index; ratio of areas under insulin/glucose curves; model-based: glucose sensitivity; rate sensitivity; potentiation) estimates were calculated from oral glucose tolerance test and meal tolerance test data. RESULTS: FINDRISC was associated with insulin sensitivity (r = -0.41, P < 0.0001), insulin/glucose areas under the curve (meal tolerance test: r = 0.29, P < 0.0001; oral glucose tolerance test: r = 0.21, P = 0.01) and potentiation factor (meal tolerance test: r = 0.21, P = 0.01). After adjusting for insulin sensitivity, these associations with ß-cell function were no longer significant. CONCLUSIONS: After adjustment for insulin sensitivity, FINDRISC was not associated with reduced ß-cell function in subjects without known Type 2 diabetes. While insulin secretion and insulin sensitivity are both components in Type 2 diabetes development, insulin sensitivity appears to be the dominant component behind the association between FINDRISC and diabetes risk.

The incidence of hypoglycaemia in Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan: a randomised trial.

AIMS: To compare the incidence of symptomatic hypoglycaemia in fasting Muslim patients with type 2 diabetes treated with sitagliptin or a sulphonylurea during Ramadan. METHODS: Patients with type 2 diabetes (age ≥ 18 years) who were treated with a stable dose of a sulphonylurea with or without metformin for at least 3 months prior to screening, who had an HbA(1c) < 10% and who expressed their intention to daytime fast during Ramadan were eligible for this open-label study. Patients were randomised in a 1 : 1 ratio to either switch to sitagliptin 100 mg qd or to remain on their prestudy sulphonylurea. Patients completed daily diary cards to document information on hypoglycaemic symptoms and complications. The primary end-point was the overall incidence of symptomatic hypoglycaemia recorded during Ramadan. RESULTS: Of the 1066 patients randomised, 1021 (n = 507 for sitagliptin and n = 514 for sulphonylurea) returned at least one completed diary card and were included in the analysis. The proportion of patients who recorded one or more symptomatic hypoglycaemic events during Ramadan was lower in the sitagliptin group (6.7%) compared with the sulphonylurea group (13.2%). The risk of symptomatic hypoglycaemia was significantly decreased with sitagliptin relative to sulphonylurea treatment (Mantel-Haenszel relative risk ratio [95% CI] = 0.51 [0.34, 0.75]; p < 0.001). There were no reported events that required medical assistance (i.e. visits to physician or emergency room or hospitalisations) or were considered severe (i.e. events that caused loss of consciousness, seizure, coma or physical injury) during Ramadan. CONCLUSIONS: In Muslim patients with type 2 diabetes who observed the fast during Ramadan, switching to a sitagliptin-based regimen decreased the risk of hypoglycaemia compared with remaining on a sulphonylurea-based regimen. The incidence of hypoglycaemia was lower with gliclazide relative to the other sulphonylurea agents and similar to that observed with sitagliptin.

Patients with type 2 diabetes mellitus have higher risk for acute pancreatitis compared with those without diabetes.

AIM: The aetiology of acute pancreatitis (AP) is complex, and many risk factors for AP are shared by patients with type 2 diabetes mellitus (T2DM). However, few have assessed risk factors for AP specifically in T2DM patients. METHODS: Patients in the General Practice Research Database (2 984 755, 5.0% with T2DM) were used to estimate incidence of AP for T2DM relative to non-diabetes, adjusting for prior pancreatitis, gallbladder disease, obesity, smoking and alcohol use. Multivariate Cox regression analysis adjusting for risk factors and Charlson comorbidity index (CCI) was used to estimate hazard ratios (HR) with 95% confidence intervals (CI). RESULTS: Between 2003 and 2007, 301 of 148 903 patients with T2DM and 2434 of almost 3 million patients without diabetes developed AP. Patients with T2DM had higher risk for AP compared with patients without diabetes (crude HR: 2.89, 95% CI: 2.56-3.27). Patients with T2DM had significantly higher rates of prior alcohol and tobacco exposure (44.2 and 61.9% vs. 34.1 and 35.9%, p < 0.001) and of comorbid conditions (14.7% with CCI > or =1 vs. 4.3%, p < 0.001). Histories of obesity, pancreatitis, gallbladder disease, smoking or alcohol use were significant predictors of AP. After adjusting for these factors, age, gender and comorbidities, the risk of developing AP remained elevated in patients with T2DM (adjusted HR: 1.49, 95% CI: 1.31-1.70). CONCLUSION: After adjusting for risk factors, patients with T2DM had an elevated risk of AP compared with patients without diabetes. Physicians should be aware of the increased risk in patients with T2DM, particularly in those with prior pancreatitis.

Characteristics of patients prescribed sitagliptin and other oral antihyperglycaemic agents in a large US claims database.

BACKGROUND AND AIMS: Non-randomised comparative studies of pharmacological agents can be biased because of differences in baseline demographics, medical history and health status of patients prescribed different therapies. Characteristics of patients with type 2 diabetes mellitus (T2DM) taking sitagliptin were compared with patients taking other oral antihyperglycaemic agents (OAHA) in a large US insurance claims database. MATERIALS AND METHODS: Using the United Health Care database, we identified T2DM patients with at least one OAHA prescription, and at least 1 year prior enrollment. Patients were classified into subcohorts including sitagliptin or other OAHA, add-on to monotherapy, and triple or more therapy. Comorbidities 12 months before the first OAHA prescription in study window were based on ICD-9 diagnostic codes and NDC codes for prescriptions. RESULTS: Prevalence of comorbidities was consistently higher for patients with sitagliptin prescriptions across most comorbidities (p < 0.05 for 20 of 30 assessed comorbidities). Overall, baseline differences were apparent (p < 0.0001) for retinopathy (5.7% vs. 3.4%), renal failure (5.1% vs. 2.6%), proteinuria (2.8% vs. 2.0%), hypertension (76.9% vs. 68.2%), congestive heart failure (3.4% vs. 2.6%), myocardial infarction (18.0% vs. 14.4%) and chronic neurological conditions (8.1% vs. 6.6%). Differences were most pronounced for initial monotherapy subcohorts. A higher proportion of sitagliptin users had prescriptions for cardiovascular medication (84.2% vs. 74.9%). CONCLUSION: Sitagliptin users had higher proportions of comorbidities and greater use of prescription medications and physician visits. Researchers should be aware that sitagliptin is prescribed to patients with seemingly worse health status. Ability to analyse observational, non-randomised studies may be limited by substantial differences in patient characteristics between different treatments.

New diagnostic and treatment guidelines for benign prostatic hyperplasia. Potential impact in the United States.

BACKGROUND: The Agency for Health Care Policy and Research (AHCPR) recently released the clinical practice guidelines for the diagnosis and treatment of benign prostatic hyperplasia. Prevalence estimates from a population-based cross-sectional study, the baseline component of a cohort study of the natural history of prostatism, were used to assess their potential impact in the United States. METHODS: The study group comprised a population-based sample of white men aged 50 to 79 years who were randomly selected within age- and residence-specific strata from the Olmsted County, Minnesota, population (1990 census, 105,720). These 1317 men completed symptom assessments and diagnostic evaluations that paralleled the AHCPR guidelines, including the measurement of urinary flow rates and, for a subset (n = 303), ultrasonic determination of postvoiding residual urine volume. RESULTS: The application of the AHCPR benign prostatic hyperplasia diagnostic guidelines to the study cohort (American Urologic Association Symptom Index > 7 and peak urinary flow rate < 15 mL/s) suggests that 17% of men aged 50 to 59 years, 27% of men aged 60 to 69 years, and 35% of men aged 70 to 9 years are eligible to discuss treatment options. Application of these percentages to the 1990 US white population suggests that approximately 5.6 million men aged 50 to 79 years are eligible to discuss treatment options. This number will double by the year 2020 owing to the aging of the population. CONCLUSION: The projected number of men potentially meeting AHCPR guidelines to discuss treatment options for benign prostatic hyperplasia could have a substantial impact on the health care system; this will be compounded by the aging of the population.

The impact of osteoporosis on quality-of-life: the OFELY cohort.

Although the long-term outcomes of osteoporosis (Op) such as fracture, kyphosis, and pain are well known, the physical, psychological, and social consequences, beyond fracture and pain, are less clear. The Osteoporosis-targeted Quality-of-life (OPTQoL) questionnaire aimed at assessing the physical difficulty, fears, and adaptations to one's daily life was developed as a cross-sectional instrument to characterize the burden of Op within a community. The purpose of this study was to assess the impact of Op and related factors on community women participating in the OFELY study in France. Femoral neck bone mineral density (BMD) and OPTQoL questionnaire data were collected from women randomly selected from a large insurance company. Data were obtained for 756 women (mean age 59 years, range 36-92), most of whom were white. Women were classified into five groups based on the extent of physical manifestations and family history of Op. Women who had prior fractures, height loss, and/or kyphosis or both reported greater physical difficulty, more adaptations to their lives, and greater fears than women reporting no such changes. Scores on the Physical Difficulty domain, however, did not differ significantly based on BMD alone (BMD T score

Effect of several recruitment strategies on response rates at baseline in a prospective cohort investigation. The Olmsted County Study of Urinary Symptoms and Health Status among Men.

Epidemiologic survey response rates were studied in relation to maneuvers introduced to improve acceptance: (a) variation in invitation letters, (b) the use of a brochure with the recruitment mailing, and (c) options for interview location. The baseline population-based survey of a prospective cohort investigation of the natural history of benign prostatic hyperplasia was used. Invitations to participate were mailed to eligible, randomly selected men aged 40 to 79 years from the Olmsted County, Minnesota, population during 1989 to 1991. Of the 3874 men identified, 2119 (55%) participated. Overall, there was no difference in response rate according to invitation characteristics (chi 2(5) = 8.02, P = 0.16). Nevertheless, response rates varied with age (chi 2(7) = 30.9, P < 0.001) and home location (rural versus Rochester city; chi 2(1) = 76.9, P < 0.001). This suggests the innovations used to bolster acceptance did not materially improve response rates. Further, since response rates were highest for men aged 60 to 74 years, men with more symptoms and free time may have joined the cohort more often than others.

Adverse effects of medications on urinary symptoms and flow rate: a community-based study.

The relationship between urinary symptoms and medication use was investigated in a community-based cross-sectional study involving a random sample of 2115 men 40-79 years of age in Olmsted County, Minnesota. The American Urological Association Symptom Index (AUASI) was generated from a validated self-administered questionnaire. Medication use was assessed by in-person interviews. While 1087 men reported daily medication use, only 136 reported daily use of medications known to affect urinary function adversely, including antidepressants (42), antihistamines (23), and bronchodilators (43). Age-adjusted AUASI scores were higher in men reporting daily use of antidepressants, and the association persisted after additionally adjusting for the Depression and Anxiety subscales of the General Psychological Well-Being Scale (adjusted mean difference, 2.1; 95% confidence interval (CI), 0.5-3.6; p = 0.008). The adjusted AUASI was also higher among men who took antihistamines daily (adjusted mean difference, 2.3; 95% CI, 0.3-4.3; p = 0.03). Lower age-adjusted urinary flow rates occurred with antidepressants, but not with antihistamines or bronchodilators. Clinicians evaluating men for causes of voiding dysfunction in accordance with the Agency for Health Care Policy and Research practice guideline for the diagnosis and management of benign prostatic hyperplasia should be aware that daily use of antidepressants or antihistamines may be associated with AUASI scores that are two to three points higher than in men not taking these medications.

The natural history of prostatism: the effects of non-response bias.

BACKGROUND: In epidemiological studies, non-response may raise the question of generalizability to the target population. Most investigations have not been able to access data that could provide information about the potential impact of non-response bias. METHODS: A 55% response rate was realized at baseline for a prospective cohort investigation of the natural history of benign prostatic hyperplasia in Olmsted County, Minnesota, during 1989-1991 (the Olmsted County Study of Urinary Symptoms and Health Status Among Men). This prompted a preliminary study of potential non-response bias among full participants, partial participants and complete non-responders. The medical diagnostic index maintained by the Rochester Epidemiology Project was used to ascertain the prevalence of specific conditions in the 9 years prior to study inception. RESULTS: The age-adjusted period prevalence rate for benign prostatic hyperplasia (%) was 9.6 (95% confidence interval [CI]: 8.1-11.0) for full participants, 8.2 (95% CI: 5.8-10.6) for partial participants and 5.3 (95% CI: 3.6-6.9) for complete non-responders. Other urologic diagnoses followed the same pattern. However, age-adjusted prevalence rates for general medical examination history and major non-urologic morbidities were decidedly similar across response groups. CONCLUSIONS: These data suggest response may have been driven, in part, by concerns about urologic disease. However, the similarity in non-urologic diagnoses and general medical examinations provide some preliminary reassurance that the 55% response rate did not necessarily compromise generalizability.

Sexual function of men ages 40 to 79 years: the Olmsted County Study of Urinary Symptoms and Health Status Among Men.

OBJECTIVES: Knowledge of male sexual function is somewhat limited because of a lack of current population-based data. This study provides information on sexual function and satisfaction in a population-based sample of men. METHODS: Men aged 40 to 79 years (n = 2115) were selected randomly from the Olmsted County population for the baseline component of a prospective cohort study (the Olmsted County Study of Urinary Symptoms and Health Status Among Men) during 1989-1990. The men completed a self-administered questionnaire that included questions about sexual concerns, performance, satisfaction, drive, and erectile dysfunction. RESULTS: For all five sexual parameters queried, the prevalence of problems and dysfunction increased with age. A comparison of men aged 70 to 79 years with men aged 40 to 49 years suggested that older men were more worried about sexual function (46.6% vs 24.9%), had worsened performance compared with a year ago (30.1% vs 10.4%), expressed extreme dissatisfaction with sexual performance (10.7% vs 1.7%), had absent sexual drive (25.9% vs 0.6%), and reported complete erectile dysfunction when sexually stimulated (27.4% vs 0.3%). Logistic regression analyses suggested that sexual dissatisfaction was significantly associated with erectile dysfunction, decreased libido, and the interaction between erectile dysfunction and libido, but not age. CONCLUSIONS: These population-based cross-sectional data corroborate the previously reported age-related decrease in sexual function. The age-related increase in dissatisfaction could, however, be accounted for primarily by the age-related increase in erectile dysfunction, decreased libido, and the interaction between erectile dysfunction and decreased libido.

Urinary incontinence in a community-based cohort: prevalence and healthcare-seeking.

OBJECTIVE: To estimate the prevalence of urinary incontinence and to assess care-seeking behavior for urinary symptoms among community-dwelling people. DESIGN: A community-based cross-sectional study. SETTING: Randomly selected men and women from Olmsted County, Minnesota. PARTICIPANTS: Two cohorts, one comprised of both men (n = 778) and women (n = 762) 50 years of age or older and a second comprised of men aged 40 years or older (n = 2150). MEASUREMENTS: Participants completed questionnaires assessing urinary incontinence in the previous 12 months, the number of days leaked, the amount leaked, and healthcare-seeking measures for urinary symptoms. RESULTS: In the first cohort, the prevalence of incontinence was 24% in men and 49% in women; 29% of men and 13% of women with incontinence had sought care for urinary symptoms. Urinary incontinence was more strongly associated with care-seeking measures for urinary symptoms in men (Odds Ratio (OR) = 4.3, 95% Confidence Interval (CI) = 2.4, 8.0) than in women (OR = 2.1, 95% CI = 1.2, 3.9). Moderate or severe urinary incontinence was associated significantly with care-seeking for urinary symptoms (OR = 10.5, 95% CI = 5.6, 19.8). In the second cohort, the prevalence of urinary incontinence was 17.3%; 8.5% of men with incontinence had sought care for urinary symptoms. Men with incontinence were 1.2 times (95% CI = .8, 1.9) as likely to seek care for urinary symptoms as men without incontinence. CONCLUSION: Our findings indicate that although urinary incontinence is relatively common in the community, care-seeking for urinary symptoms among persons with urinary incontinence is low, particularly among women, for whom the prevalence exceeds 40% between the ages of 50 and 70 years. These findings suggest that strategies to promote care-seeking for incontinence need to be investigated and employed in the community.

Natural history and epidemiology of benign prostatic hyperplasia: relationship among urologic measures.

Numerically weak correlations can stem from research studies for numerous reasons, some of which have little to do with lack of true physiologic relationships. Previous investigators have reported relatively weak correlations among urologic measures, mostly based on patients referred to urologic clinics. Such samples of patients may be prone to self-selection or referral bias. Men seeking medical care for urinary symptoms are more likely to have more severe symptoms, low urinary flow rates, and prostatic enlargement, and hence clinic-based samples may reflect a narrow spectrum in urologic measures, resulting in attenuated correlation coefficients. Measurement error in the technique or equipment, lack of specificity, and within-patient variability can also attenuate correlations. Thus, the characteristics of the sample upon which correlations are calculated must be considered in the interpretation of the magnitude of relationships among measurements. Possibly due to the broader spectrum, community-based studies have recently found modest but somewhat stronger relationships among urologic measures than previously documented. Such correlations are comparable to those found in other disease areas. In addition, such studies have documented that symptoms, urinary flow rate, and prostatic enlargement are predictive of long-term complications, such as acute urinary retention, with predictive relationships comparable to those found in other disease areas. Thus, the relationships among and predictive ability of urologic measures may be stronger than currently appreciated.

Do prostate size and urinary flow rates predict health care-seeking behavior for urinary symptoms in men?

OBJECTIVES: To estimate the association between health care-seeking behavior for urinary dysfunction and clinical, physiologic, and anatomic measures of disease. METHODS: A randomly selected sample (n = 475) of men aged 40 to 79 years from Olmsted County, Minnesota, was administered a previously validated questionnaire that assessed the frequency of and bother associated with urinary symptoms and health care-seeking behavior in the past year. Peak urinary flow rates were measured with a standard urometer and prostatic volume was determined by transrectal ultrasound. RESULTS: Overall, 21 of the 475 men (4%) had seen a doctor in the past year for urinary symptoms. Men with moderate to severe symptoms (American Urological Association [AUA] Symptom Scores > 7) were 3.4 times as likely (95% confidence interval [CI] = 1.4, 8.3) to have sought medical care in the past year as men with none to mild symptoms. Men with enlarged prostates (> 40 mL) were 3.9 times as likely to have sought health care (95% CI = 1.6, 9.6), whereas men with depressed peak urine flow rates (< 10 mL/s) were only slightly more likely to have sought health care for urinary symptoms (odds ratio = 2.1, 95% CI = 0.7, 6.5). Overall, 76% of men who had sought medical care had prostatic enlargement, depressed peak urine flow rates, or moderate-severe symptoms (sensitivity). In contrast, only 55% of men who did not seek health care for urinary symptoms in the past year had mild symptoms, normal prostatic volume, and normal peak urine flow rates (specificity). CONCLUSIONS: These data suggest that clinical, physiologic, and anatomic measures of prostatism do not adequately distinguish the men who seek medical care for their urinary symptoms from those who do not. There remain some factor(s) that apparently lead some men with minor disease to seek care and that prevent men with measurable disease from seeking care.

Natural history of prostatism: factors associated with discordance between frequency and bother of urinary symptoms.

The objective of this study was to assess the association between frequency and bother of urinary symptoms in a population-based cohort of men and to identify psychosocial factors that are related to reporting heightened or subdued bother relative to symptom frequency. The survey was conducted among men aged forty to seventy-nine years in Olmsted County, Minnesota, the baseline component of a prospective cohort study. Men were queried about the frequency of urinary symptom occurrence and the perceived bother associated with the symptoms. A regression analysis of American Urologic Association (AUA) bother scores on AUA frequency scores demonstrated a tight correspondence (r2 = 0.71). Men with bother scores greater than predicted from their frequency scores were more likely to have sought health care for their urinary symptoms than men whose bother was close to predicted (14 versus 5 percent, respectively). These men with heightened bother were older, poorer, more anxious, and had lower general psychologic well-being scores than the men whose bother was similar to that expected from their reported frequency. Men whose bother was lower than would be expected were less likely to have sought health care for urinary symptoms in the past year (3%) but were of similar age and socioeconomic status as compared with men whose bother was close to expected. These men, however, were more depressed than men whose bother was commensurate with reported frequency. While the men who reported greater bother than expected from their symptom frequency were more likely to have sought medical care for urinary symptoms in the past year, it is not clear whether this greater health-care-seeking behavior is because bother captures an additional component of urologic disease or is a manifestation of psychosocial differences.

Does the mode of questionnaire administration affect the reporting of urinary symptoms?

OBJECTIVES: To assess the effect of modes of administration (self-administered questionnaires, oral face-to-face interview, and telephone interview) on responses to the American Urological Association Symptom Index (AUASI) in randomly selected community men. METHODS: An age-stratified random sample of 475 white male residents of Olmsted County, Minnesota, aged 40 to 79 years, without prior prostate surgery or prostate cancer were queried about urinary symptom frequency twice at baseline and twice approximately 2 years later using questions with wording similar to the AUASI: At baseline and first follow-up, questionnaires were self-administered initially, followed by a structured interview by a female urology nurse within 2 to 28 weeks. A subset of 200 randomly selected men received a telephone interview by a female research assistant following the self-administered questionnaire given at a second follow-up approximately 4 years after baseline. RESULTS: Mean symptom scores obtained by oral interview were 1 to 2 points lower than those from self-administered questionnaires (P < 0.01). In a random subset (n = 200) interviewed by telephone, mean AUASI scores were as much as 4 points lower than those from self-completed questionnaires. CONCLUSIONS: Values of the AUASI obtained by interviewer administration may be lower than those obtained by self-administered questionnaires. When assessment of change in urinary symptoms over time is of interest, the same standardized method of questionnaire administration should be used at baseline and follow-up evaluations to avoid introducing artifactual differences related to the mode of administration.

Use of a prostate model to assist in training for digital rectal examination.

OBJECTIVES: To assess the accuracy of prostate size estimation on digital rectal examination (DRE) before and after training with a three-dimensional prostate model relative to prostate volume by transrectal ultrasound (TRUS). METHODS: A total of 100 subjects underwent DRE by one of four family physicians (FP1, n = 34; FP2, n = 26; FP3, n = 22; and FP4, n = 18). One half were examined before any training on DRE prostate size examination and one half after the physicians were trained. Training involved teaching with a three-dimensional prostate model having posterior surface areas corresponding to the average dimensions of six different prostate volumes. The FPs were instructed to estimate the prostate size on the DRE to the nearest 5 g. A single urologist unaware of the DRE results performed TRUS on all patients to measure the prostate volume. RESULTS: Before training, the DRE size estimates ranged from 10 to 100 g (mean +/- SD 32.8 +/- 21.6), with a TRUS volume of 11 to 122 g (mean +/- SD 38.9 +/- 23.1). The correlation between the DRE and TRUS estimates was 0.25, suggesting low agreement (intraclass correlation coefficient [ICC] 0.35, 95% confidence interval 0.31, 0. 38). After training, 50 different patients had DRE size estimates of 10 to 100 g (mean +/- SD 39.4 +/- 19.7) and TRUS volume of 10 to 119 g (mean +/- SD 41.5 +/- 24.1). The correlation between the techniques was higher in patients examined after training (r = 0. 765), suggesting much better agreement between the techniques (ICC 0. 87; 95% confidence interval 0.86, 0.88). Among the physicians, agreement between DRE and TRUS was higher after training (ICC 0.64 to 0.96) than before training (ICC 0.02 to 0.49). CONCLUSIONS: Although the subjects examined before and after training differed, the agreement between TRUS and DRE prostate size estimates by the FPs appeared to be stronger after training with a three-dimensional prostate model. This model may be a useful tool to assist in training FPs and medical students to measure prostate size on DRE.

Natural history of prostatism: impact of urinary symptoms on quality of life in 2115 randomly selected community men.

OBJECTIVES: To assess the impact of urinary symptoms on health-related quality of life (QoL), including degree of bother, worry, interference with daily activities, psychological well-being, sexual function, and general health in a community-based cohort of men. METHODS: Eligible white men (n = 2115) aged 40 to 79 years who had not undergone previous prostate surgery or had prostate cancer were randomly selected from county residents. These subjects completed a questionnaire, which asked them about frequency and bother of urinary symptoms, interference with daily activities, psychological well-being, worry about urologic disease, sexual functioning, and general health. RESULTS: Men with moderate to severe voiding symptoms reported, on average, four to six times the degree of bother and interference with daily activities and twice the level of worry of men with mild symptoms. Nearly five times the degree of bother and interference was reported for those with mild than with no symptoms. A higher percentage of men with moderate to severe symptoms (26% to 33%) than mild symptoms (< 8%) reported limiting fluids before bed, travel, or driving 2 hours. Receiver operating characteristic curves support the recommended symptom index cutpoint for moderate symptoms (= 8) by differentiating men with and without bother, interference with daily living, or dissatisfaction with urinary condition. CONCLUSIONS: Moderate to severe urinary symptoms have a significant impact on men's lives in terms of degree of bother, worry, interference with daily living, and psychological well-being. The recommended cutpoint on symptom index differentiates men with and without decrement in health-related quality of life.