Descriptive, real-world treatment patterns, resource use, and total cost of care among eculizumab- and ravulizumab-treated members with paroxysmal nocturnal hemoglobinuria.

BACKGROUND: Paroxysmal nocturnal hemoglobinuria (PNH) is a rare, genetic, chronic, and life-threatening blood disease with an estimated prevalence of 13 per 1,000,000 persons reported in the United States. Available at analysis, PNH treatment included the use of C5 inhibitors (C5is), which prevent formation of membrane attack complex and consequently intravascular hemolysis. Limited real-world evidence suggests some individuals with PNH continue to experience anemia and breakthrough hemolysis (BTH) after C5i treatment, indicating unmet needs. OBJECTIVE: To describe real-world treatment patterns and outcomes among individuals treated with C5is, eculizumab (ECU), and ravulizumab (RAV), focusing on affordability challenges and therapy unmet needs from a US payer perspective. METHODS: This retrospective cohort study was conducted using deidentified data from Prime Therapeutics' approximately 15 million commercially insured US members with integrated medical and pharmacy claims data. Members were identified between January 1, 2018, and December 31, 2020. Inclusion criteria for cohort identification were adults aged 18 years or older at ECU or RAV index date requiring 2 or more claims for ECU or 1 or more claims for RAV. ECU and RAV users were excluded if they had a claim indicating treatment for a US Food and Drug Administration (FDA)-approved non-PNH indication. Members were required to be continuously enrolled 6 months before and 12 months after their index ECU or RAV claim. Real-world C5i claims-based treatment dosage and frequency patterns were compared with FDA-labeled dosing. Clinical outcomes, including transfusions and BTH events, were identified in the pre-index and post-index periods. Health care resource use and costs were calculated after network discounts, including member share. RESULTS: A total of 86 commercial members met analysis criteria: 34 in the ECU cohort and 52 in the RAV cohort. The mean age was 42.6 years, and 54.6% were female. Estimated higher-than-label PNH-recommended dosage occurred in 38.2% of ECU and 9.6% of RAV members. In total, 29.4% of ECU and 17.3% of RAV members had 4 or more transfusions in the post-index period. Additionally, 29.4% of ECU and 13.5% of RAV members had 1 or more BTH episodes. Post-index period mean per member total health care costs were $711,785 among ECU members and $624,911 among RAV members, and C5i costs accounted for 79.7% and 85.6% of total health care costs, respectively. CONCLUSIONS: Although all members received at minimum FDA-approved dosages, transfusions and BTH events continue to occur for some members. These findings indicate potentially inadequate therapy responses in a substantial subset of C5i users, adding additional therapy costs to an already extremely expensive therapy. DISCLOSURES: This study was funded by Apellis Pharmaceuticals. Drs Broderick and Fishman report employment by Apellis Pharmaceuticals and own stock options. Dr Burke reports employment by Prime Therapeutics, LLC, which has received research funding from Apellis Pharmaceuticals. Dr Gleason reports employment by Prime Therapeutics, LLC, which has received research funding from Apellis Pharmaceuticals; serves on the advisory committee at the Institute for Clinical and Economic Review; and has served on the Board of Directors at the Academy of Managed Care Pharmacy.

Longitudinal treatment patterns among US patients with atherosclerotic cardiovascular disease or familial hypercholesterolemia initiating lipid-lowering pharmacotherapy.

BACKGROUND: The most recent American College of Cardiology-American Heart Association guidelines recommend high-dose statin therapy for most patients with confirmed atherosclerotic cardiovascular disease (ASCVD) and patients with high cardiovascular risk. There is limited information regarding long-term treatment patterns among these patients. OBJECTIVE: To examine longitudinal treatment modifications in patients with ASCVD or familial hypercholesterolemia (FH). METHODS: This retrospective analysis of administrative claims data identified patients initiating statin or ezetimibe therapy between January 1, 2007, and December 31, 2012, who had evidence of ASCVD or FH. Patients were followed for up to 3 years and up to 4 treatment episodes. After initial treatment, subsequent treatment episodes began on the date of a treatment modification, which included discontinuation, statin dose change, switching, and augmentation. RESULTS: A total of 92,621 patients (mean age 64.7 years, 57.3% male) were identified; 91,740 had ASCVD, 937 had FH (56 had both). Most ASCVD (89.6%) and FH (85.8%) patients initiated on statin monotherapy. The most common treatment modification in the first treatment episode was discontinuation (ASCVD: 42.0%; FH: 58.4%); among patients who discontinued, most reinitiated therapy (70.5% of ASCVD, 76.8% of FH). Most ASCVD (68.2%) and FH (71.1%) patients initiated on moderate-dose statins; statin dose increase occurred in 10.3% of ASCVD and 18.5% of FH patients in the first episode. CONCLUSION: Among patients with high cardiovascular risk, most initiated on moderate-dose statins with infrequent uptitration. In light of the recent American College of Cardiology-American Heart Association guidelines, statin initiation practices will need to change to ensure appropriate therapy for high-risk patients.

From Value Assessment to Value Cocreation: Informing Clinical Decision-Making with Medical Claims Data.

Big data and advances in analytical processes represent an opportunity for the healthcare industry to make better evidence-based decisions on the value generated by various tests, procedures, and interventions. Value-based reimbursement is the process of identifying and compensating healthcare providers based on whether their services improve quality of care without increasing cost of care or maintain quality of care while decreasing costs. In this article, we motivate and illustrate the potential opportunities for payers and providers to collaborate and evaluate the clinical and economic efficacy of different healthcare services. We conduct a case study of a firm that offers advanced biomarker and disease state management services for cardiovascular and cardiometabolic conditions. A value-based analysis that comprised a retrospective case/control cohort design was conducted, and claims data for over 7000 subjects who received these services were compared to a matched control cohort. Study subjects were commercial and Medicare Advantage enrollees with evidence of CHD, diabetes, or a related condition. Analysis of medical claims data showed a lower proportion of patients who received biomarker testing and disease state management services experienced a MI (p < 0.01) or diabetic complications (p < 0.001). No significant increase in cost of care was found between the two cohorts. Our results illustrate the opportunity healthcare payers such as Medicare and commercial insurance companies have in terms of identifying value-creating healthcare interventions. However, payers and providers also need to pursue system integration efforts to further automate the identification and dissemination of clinically and economically efficacious treatment plans to ensure at-risk patients receive the treatments and interventions that will benefit them the most.

Characterizing pulmonary hypertension-related hospitalization costs among Medicare Advantage or commercially insured patients with pulmonary arterial hypertension: a retrospective database study.

OBJECTIVES: This study assessed pulmonary hypertension (PH)-related hospitalizations, including readmissions, among US patients with pulmonary arterial hypertension (PAH), a rare disease characterized by high morbidity and premature mortality. STUDY DESIGN: Analysis of claims data (January 1, 2007-April 30, 2011) from adult enrollees with commercial or Medicare Advantage with Part D coverage from a large US health plan. METHODS: Patients with PAH were identified based on ≥ 1 medical claim with a PH-related diagnostic code (International Classification of Diseases, Ninth Edition, Clinical Modification code 416.0 for primary pulmonary hypertension or 416.8 for other chronic pulmonary heart disease) and ≥ 1 pharmacy claim for a medication indicated for PAH or frequently used in PAH. Data were analyzed for patients with ≥ 1 hospitalization with a primary or secondary diagnostic code of PH. PH-related hospitalizations were defined as those with ≥ 1 PH-related diagnostic code. The principal diagnosis was defined as the diagnosis most frequently in the first-listed position on a hospitalization's facility claims. Total hospitalization costs (inflated to 2011 US$) and length of stay (LOS) were analyzed. A subgroup analysis evaluated readmissions. RESULTS: Of 4009 enrollees meeting inclusion criteria, 2275 had ≥ 1 PH-related hospitalization during follow-up: 56.9% were female, 59.4% were < 65 years old, and 67.8% had commercial insurance. Mean (SD) costs across all hospitalizations were $46,118 ($135,137) for commercially insured and $16,319 ($30,046) for Medicare Advantage enrollees; LOS was 10.9 (20.4) and 12.8 (21.2) days, respectively. Costs and LOS were higher for admissions with a principal diagnosis of PH compared with other principal diagnoses: $61,922 ($213,596) versus $42,455 ($108,925) and 14.2 (32.3) versus 10.2 (16.4) days, respectively, for the commercially insured, and $19,584 ($29,501) versus $15,904 ($30,097) and 16.7 (25.7) versus 12.3 (20.5) days, respectively, for Medicare Advantage enrollees. Of the 954 patients who experienced ≥ 1 PH-related readmission within the first year after discharge from the initial hospitalization, 483 (50.6%), 246 (25.8%), and 225 (23.6%) patients had 1, 2, and ≥ 3 readmissions, respectively. CONCLUSIONS: PH-related hospitalizations incur substantial healthcare costs and require long hospital stays for patients with PAH; many are readmitted within 1 year. Improved treatment approaches are needed to reduce PAH disease progression leading to costly and burdensome inpatient stays.

Does a claims diagnosis of autism mean a true case?

The purpose of this study was to validate autism spectrum disorder cases identified through claims-based case identification algorithms against a clinical review of medical charts. Charts were reviewed for 432 children who fell into one of the three following groups: (a) more than or equal to two claims with an autism spectrum disorder diagnosis code (n = 182), (b) one claim with an autism spectrum disorder diagnosis code (n = 190), and (c) those who had no claims for autism spectrum disorder but had claims for other developmental or neurological conditions (n = 60). The algorithm-based diagnoses were compared with documented autism spectrum disorders in the medical charts. The algorithm requiring more than or equal to two claims for autism spectrum disorder generated a positive predictive value of 87.4%, which suggests that such an algorithm is a valid means to identify true autism spectrum disorder cases in claims data.

The impact of diabetes counseling and education: clinical and cost outcomes from a large population of US managed care patients with type 2 diabetes.

PURPOSE: The purpose of this study is to examine outcomes in adult patients with type 2 diabetes mellitus who received diabetes counseling and education (C/E) services compared with those who did not. METHODS: A matched, retrospective cohort study of 17 483 C/E recipients and 17 470 non-C/E controls was followed for up to 12 months. Outcomes included glycemic control (glycosylated hemoglobin A1C levels <7.0%), hypoglycemic events, and health care utilization and costs. RESULTS: Compared with the non-C/E group, patients in the C/E group had significantly lower A1C (7.7% vs 7.2%) and were more likely to achieve glycemic control at 6 months' follow-up; they were also more likely to have a hypoglycemic event. During the 1-year period following the index date, C/E recipients had more inpatient visits (0.21 vs 0.20 visits per patient) and ambulatory visits (21.5 vs 18.6 visits per patient) compared with non-C/E controls. The increased use of health care services in the C/E groups was associated with $2388 higher annual overall costs and $827 higher diabetes-related costs. CONCLUSIONS: Diabetes C/E is associated with improved glycemic control, albeit with a slight increase in the risk of hypoglycemia. C/E was associated with higher health care costs across 12 months. Further analyses are needed to evaluate long-term cost-effectiveness of diabetes counseling and education.

Health care costs in patients with fibromyalgia on pregabalin vs. duloxetine.

BACKGROUND: The economic burden associated with fibromyalgia in the U.S. is substantial. The objective of this study was to compare changes in health care costs in fibromyalgia patients initiated on pregabalin and duloxetine in real-world settings. METHODS: Patients (≥ 18 years old) initiating pregabalin or duloxetine between June 1, 2007 and December 31, 2008 were identified using a U.S. managed care database. Patients were selected if they had ≥ 2 medical claims for fibromyalgia (ICD-9-CM, 729.1) at least 90 days apart or ≥ 1 claim for fibromyalgia followed within 30 days by a pharmacy claim for pregabalin. The date of the first pregabalin or duloxetine prescription was defined as the index date, and continuous enrollment for 6-month pre- and postindex periods was required. RESULTS: A total of 1,616 pregabalin and 207 duloxetine patients were identified. Treatment differences between pregabalin and duloxetine in the pre-/postindex change in mean [SD] all-cause total health care costs ($1,307 [16,747] vs. -$158 [17,337]; P = 0.24) or fibromyalgia-related total health care costs ($584 [3,834] vs. $759 [2,133]; P = 0.32) were not significant. Multivariate analysis using difference-in-differences models showed no significant difference in all-cause costs (mean cost ratio = 1.05, 95% CI: 0.84 to 1.31) or fibromyalgia-related costs (0.85, 95% CI: 0.61 to 1.18) between treatments during the postindex period. CONCLUSION: No significant differences were found between pregabalin and duloxetine in the pre- to postindex change in mean all-cause or fibromyalgia-related total health care costs.

Health care costs in patients with painful diabetic peripheral neuropathy prescribed pregabalin or duloxetine.

BACKGROUND: Pregabalin and duloxetine are two FDA-approved medications for the treatment of pain associated with diabetic peripheral neuropathy (pDPN). The objective of this study was to compare changes in all-cause and pDPN-related health care costs in patients with pDPN initiated on pregabalin or duloxetine. METHODS: Patients at least 18 years of age initiating pregabalin or duloxetine between March 1, 2006 and December 31, 2008 were identified from a large U.S. managed care plan database. The date of the first pregabalin or duloxetine prescription was defined as the index date. Patients with claims-based evidence of pDPN and who had continuous enrollment for 6-month pre- and post-index periods were selected for study inclusion. Duloxetine patients with depression or generalized anxiety disorder (GAD) were excluded. All-cause and pDPN-related total health care costs (over 6 month pre-index and post-index periods) were analyzed with difference-in-differences (DiD) models. RESULTS: A total of 2,136 patients (1,785 pregabalin and 351 duloxetine) were identified. No significant differences in gender, age, or pre-index Quan-Charlson comorbidity score were observed between the two cohorts. No significant differences (pregabalin vs. duloxetine) in pre-index to post-index change in mean all-cause health care costs ($1,411 vs. $1,560, P = 0.93) or mean pDPN-related health care costs ($704 vs. -$240, P = 0.22) were found. The DiD models showed no significant difference in all-cause (mean) costs attributable to pregabalin vs. duloxetine therapy between pre-index and post-index periods (mean cost ratio = 0.97, 95% CI: 0.75 to 1.26), but showed that patients receiving pregabalin had a significantly higher increase in pDPN-related costs compared with patients receiving duloxetine (mean cost ratio = 2.35, 95% CI: 1.01 to 5.46). However, the difference (pre- to post-index) in pDPN-related costs attributable to pregabalin vs. duloxetine therapy was nonsignificant (mean cost ratio = 2.30, 95% CI: 0.93 to 5.68) in a sensitivity analysis in which patients with depression and GAD were excluded from both cohorts. CONCLUSION: No differences were noted in all-cause costs attributable to pregabalin or duloxetine. Although patients receiving pregabalin had a significantly greater pre- to post-index increase in pDPN-related health care costs compared with patients receiving duloxetine, this may have been due to an imbalance in patient exclusion criteria between cohorts.

Impact of persistence with antiplatelet therapy on recurrent ischemic stroke and predictors of nonpersistence among ischemic stroke survivors.

OBJECTIVE: Medication adherence is an important component of effective secondary stroke prevention. The objectives of this study were to examine the impact of persistence with two prescription antiplatelet therapies on the outcome of recurrent hospitalized stroke, and to identify the predictors of nonpersistence with these antiplatelet therapies. RESEARCH DESIGN AND METHODS: Administrative claims from a large, geographically diverse US health plan were used to evaluate acetylsalicylic acid / extended-release dipyridamole (ASA/ERDP) treated and clopidogrel treated patients from November 1, 2002 - December 31, 2005 who had an ischemic stroke requiring hospitalization. Nonpersistence was defined as failure to refill index medication within 30 days from the run-out date of the prior prescription. A Cox proportional hazards model was used to identify key factors associated with time to nonpersistence. MAIN OUTCOME MEASURES: Patient demographic variables, clinical characteristics, comorbidities hypothesized to affect the risk of current stroke, stroke outcomes, treatment patterns, and compliance were assessed. RESULTS: A total of 1413 patients hospitalized for ischemic stroke were identified. Mean age was 63.4 years and 44.2% were female. The proportion of patients persistent per person-year was 45.1%. Persistence with medication was significantly associated with a longer time to recurrent hospitalized stroke (HR 0.275; 95% CI 0.134-0.564; p < 0.0004). A medication copayment of >$40 (relative to a copayment of < or =$20) was the only significant factor predicting time to nonpersistence (HR 1.320; 95% CI 1.091-1.596; p < 0.0042). CONCLUSIONS: Persistence with antiplatelet medication within a cohort of hospitalized ischemic stroke patients was associated with a 72.5% lower likelihood of recurrent hospitalized stroke. Higher medication copayment was found to negatively impact patient persistence with antiplatelet therapy. The findings of this study must be considered within the limitations of database analysis, as claims data are collected for the purpose of payment and not research.

LDL-C goal attainment in patients who remain on atorvastatin or switch to equivalent or non-equivalent doses of simvastatin: a retrospective matched cohort study in clinical practice.

BACKGROUND: As clinical trials have shown the benefits of more intensive cholesterol control, treatment targets for low-density lipoprotein cholesterol (LDL-C) have decreased progressively. At the same time, physicians have been encouraged to contain costs by prescribing cheaper, generic statins for cholesterol management. To determine how these possibly conflicting goals are managed in clinical practice, we examined LDL-C control in patients switched from a potent, branded statin (atorvastatin) to a less potent, generic statin (simvastatin). METHODS: Patients who switched from atorvastatin to simvastatin between July 2006 and January 2008 were retrospectively identified from a US medical and pharmacy claims database, and matched with controls remaining on atorvastatin. Outcomes measured were the number of switched patients receiving a simvastatin milligram dose>or=2 times their previous atorvastatin dose, changes in LDL-C levels, and percentage of patients achieving recommended LDL-C targets. All study variables were analyzed descriptively. RESULTS: After applying exclusion and inclusion criteria, 1048 patients who switched from atorvastatin to simvastatin and 1048 matched controls who remained on atorvastatin were included. Among the switchers, 379 (36%) received an inappropriately low dose of simvastatin (<2 times atorvastatin dose). In patients remaining on atorvastatin, mean LDL-C decreased from 105.7 mg/dL to 102.3 mg/dL after 44 weeks, whereas in switched patients, LDL-C remained similar, at 105.9 mg/dL on atorvastatin and 105.8 mg/dL on simvastatin. Before switching, when all patients were receiving atorvastatin, 67.4% of switchers and 69.9% of controls achieved recommended LDL-C targets. After switching, significantly fewer switchers than controls met LDL-C targets (69.1% vs 74.6%; P=0.005). However, among patients who switched to an equivalent dose of simvastatin (>or=2 times prior atorvastatin dose), similar proportions met LDL-C targets (72.8% vs 74.6% of controls; P=0.402), whereas among patients who switched to inappropriate non-equivalent dose of simvastatin, a significantly lower proportion met LDL-C targets (62.5% vs 74.6% of controls; P=0.001). CONCLUSIONS: Continuing atorvastatin was associated with lower LDL-C levels and better LDL-C target attainment compared with switching to simvastatin. Patients switched to an equivalent simvastatin dose had lower LDL-C levels and were more likely to achieve LDL-C targets than patients switched to a non-equivalent dose, suggesting physicians must consider dosage equivalence when switching statins, and should measure LDL-C and titrate statins as necessary to achieve LDL-C control.

The incidence of central serous chorioretinopathy in Olmsted County, Minnesota, 1980-2002.

PURPOSE: To determine the incidence of central serous chorioretinopathy (CSC) in Olmsted County, Minnesota from 1980 to 2002, determine the associated risk factors for CSC based on previously reported risk factors, investigate for any new risk factors not previously reported, and determine a population-based recurrence rate. DESIGN: Population-based retrospective cohort and case-control study. PARTICIPANTS: Cases were all patients with newly diagnosed CSC in Olmsted County Minnesota, from January 1, 1980 through December 31, 2002. Controls were selected from the same general population. Control group 1 patients were matched for age, gender, length of medical follow-up, and index date (corresponding with date of diagnosis for cases). Control group 2 patients were matched for all the same criteria as control group 1, and they had documented normal eye examination results. METHODS: Using the Rochester Epidemiology Project medical records linkage system, which captures virtually all medical care provided to residents of Olmsted County, Minnesota, we identified all cases of CSC in county residents between 1980 and 2002. We reviewed the entire medical record of cases and applied standardized criteria for CSC. The medical records of cases and controls were reviewed for the presence of risk factors as well. MAIN OUTCOME MEASURE: Incidence of CSC. Secondary outcomes were also evaluated. RESULTS: There were 74 cases (63 men, 11 women) of CSC. Mean annual age-adjusted incidences per 100 000 were 9.9 (95% confidence interval [CI], 7.4-12.4) for men and 1.7 (95% CI, 0.7-2.7) for women. The incidence of CSC was approximately 6 times higher in men than in women (P<0.001). There were no significant risk factors identified for CSC. Twenty-three (31%) of the 74 patients with CSC had recurrences. The mean number of recurrences was 1.5 (range, 1-4). Median time from diagnosis to recurrence was 1.3 years (range, 0.4-18.2). CONCLUSION: The incidence of CSC has not previously been reported in a population-based study. In accordance with previous studies, we found that CSC occurs more frequently in men than in women.

Associations between diabetes and clinical markers of benign prostatic hyperplasia among community-dwelling Black and White men.

OBJECTIVE: The aim of this study was to examine associations between diabetes and clinical markers of benign prostatic hyperplasia (BPH) in community-dwelling white and black men aged 40-79 years. RESEARCH DESIGN AND METHODS: Data from the Olmsted County Study of Urinary Symptoms and Health Status and the Flint Men's Health Study were combined for a total study sample of 2,484 men. Severity of lower urinary tract symptoms (LUTS), peak urinary flow rates, prostate volume, and serum prostate-specific antigen (PSA) levels were examined by self-reported physician-diagnosed diabetes. RESULTS: Overall, 170 men (6.8%) reported a history of diabetes. Increased irritative LUTS and specifically nocturia were positively associated with diabetes. These patterns were consistent across race and persisted after adjustment for age, BMI, and various indicators of socioeconomic status. Furthermore, the relationship between irritative LUTS and diabetes was greater in black men. No significant associations were observed between diabetes and prostate volume, PSA level, and peak urinary flow rate. CONCLUSIONS: Our multiethnic community-based study demonstrates positive associations between diabetes and irritative LUTS and nocturia. Moreover, the association between irritative LUTS and diabetes is increased in black men. There was no strong evidence for an association between diabetes and BPH across measures more specific to BPH (i.e., prostate volume, PSA, and peak urinary flow rate). Taken together, our findings suggest that the presence of diabetes may be less related to prostate growth and more related to the dynamic components of lower urinary tract function. Further evaluations of the association between diabetes and BPH and related racial variations are warranted.

In vivo evaluation of biomechanical anterior cervical plate failure.

Anterior cervical plate (ACP) failure is rarely addressed in the literature. In this retrospective, observational, longitudinal, cohort study, the objectives were to (1) identify incidences of in vivo biomechanical failure in commercially available, US Food and Drug Administration-approved ACP systems, (2) describe modes of failure, (3) suggest structural explanations for system failure, and (4) discuss complications and treatment of patients with failed ACP systems. Investigators retrospectively identified patients who underwent anterior cervical procedures followed by use of ACP as a fusion adjunct and showed evidence of ACP failure on plain radiographs. Components of the ACP system that led to failure were identified and examined. A total of 240 patients received ACP supplementation of anterior cervical fusion constructs during the 9.5-y study period. Evidence of ACP failure was noted in 7 patients (3.3%), and an eighth patient was referred for evaluation after ACP failure. Screw-plate interface failure occurred in all 8 cases. The biomechanical method by which the bone screw head was secured into the vertebral body, or against the ACP, the use of hybrid systems, the surgical technique selected, and host factors were used to determine the rate of failure. Concern for esophageal or other tissue injury often necessitated ACP removal. Screw-plate interface failure, which was found to be the most common mode of biomechanical ACP failure, may occur in hybrid constructs and in systems that do not create a rigid interface between the screw head and the ACP. Surgical technique and patient host factors may also influence the rate of biomechanical construct failure.

Incidence of cataract surgery from 1980 through 2004: 25-year population-based study.

PURPOSE: To estimate sex- and age-specific incidence rates of cataract surgery in a defined United States population and evaluate the change in incidence over time. SETTING: Department of Ophthalmology, Mayo Clinic College of Medicine, Rochester, Minnesota, USA. METHODS: Rochester Epidemiology Project databases were used to identify all incident cataract surgeries in Olmsted County, Minnesota, residents during the 25-year period from January 1, 1980, through December 31, 2004. Annual incidence rates for each sex and 10-year age group were calculated and adjusted to the 2000 U.S. white population. Change in incidence over time was assessed by fitting generalized linear models assuming a Poisson error structure. RESULTS: During the study period, 10 245 cataract extractions were performed in 7141 residents of all ages. Overall, the age-adjusted cataract surgery incident rate per 100000 residents was 548 (95% confidence interval [CI], 534-561) for women, 462 (95% CI, 447-478) for men, and 511 (95% CI, 501-521) for all residents. The incidence of cataract surgery increased 500% among women and 467% among men during the study period (P<.001). Overall, the incidence of cataract surgery was highest in residents 70 years and older (3538 surgeries [95% CI, 3322-3764] per 100,000 residents). CONCLUSIONS: This population-based study found a substantial increase in incident cataract surgery among Olmsted County residents during the 25-year study period. The rate of cataract surgery increased in a nearly linear fashion during a period when phacoemulsification replaced extracapsular cataract extraction in the community.

Diabetes and sexual dysfunction: results from the Olmsted County study of urinary symptoms and health status among men.

PURPOSE: We examined the association of diabetes and domains of sexual dysfunction in a population based sample of men residing in Olmsted County, Minnesota. MATERIALS AND METHODS: A cohort of 2,115 white men 40 to 79 years old as of January 1, 1990 was randomly selected from the Olmsted County population. Men who had a history of prostate or bladder surgery, urethral surgery or stricture, or medical or other neurological condition that could affect normal urinary function were excluded from analysis. Diabetes itself was not used as an exclusionary criterion, although those with end stage organ failure as a result of diabetes were excluded. A previously validated male sexual function index was included in the questionnaires administrated to the cohort in 1996, which consisted of 11 questions on the 5 sexual function domains of sexual drive, erectile function, ejaculatory function, sexual problem assessment and sexual satisfaction. The baseline questionnaire also included whether they had ever been diagnosed by a physician as having diabetes. Only men with regular sexual partners were included. RESULTS: Individuals with diabetes at baseline had significantly greater dysfunction in all 5 sexual function domains. In multivariate adjusted analyses diabetes was significantly associated with all sexual dysfunction domains. The associations remained significant after adjusting for numerous predictors of sexual dysfunction. CONCLUSIONS: The presence of diabetes at baseline was significantly associated not only with erectile dysfunction but with all aspects of sexual dysfunction, including sexual drive, ejaculatory function, sexual problems and sexual satisfaction in this population based sample of men residing in Olmsted County.

The risk of glaucoma in pseudoexfoliation syndrome.

PURPOSE: To determine the conversion rate of pseudoexfoliation syndrome (PEX) to pseudoexfoliative glaucoma or treated ocular hypertension. METHODS: Retrospective community-based study of newly diagnosed cases of PEX syndrome in all residents of Olmsted County, Minnesota between 1976 and 1991. The end point was considered the initiation of therapy, which included patients with glaucoma (optic disc damage or visual field defects), or with elevated intraocular pressure (IOP) >21 mm Hg in the presence of risk factors; the subsequent development of damage in the latter group was also determined. RESULTS: Two hundred fifty-five patients (318 eyes) had newly diagnosed PEX over the 15-year interval. Mean age was 73+/-10 years; 78% (199/255) were female. Of all PEX patients, 16% were placed on therapy at the time of initial diagnosis of PEX. In the remaining PEX patients, the probability of being placed on therapy was 44% at 15 years. Bilateral PEX was present in 25% at initial diagnosis and developed in another 29% by 15 years. Of those not placed on therapy, 16% (23/142) had IOP increase 5+ mm Hg during follow-up, with 11% (16/142) reaching 22 mm Hg or more. The strongest risk factors for converting to therapy were IOP at initial diagnosis of PEX and bilateral involvement. CONCLUSIONS: In a geographically defined population of PEX patients, 16% required treatment upon presentation. Of the remaining PEX patients, 44% received therapy over the next 15 years.

Incidence and types of childhood esotropia: a population-based study.

OBJECTIVE: To describe the incidence and types of childhood esotropia in a defined population. DESIGN: Retrospective population-based cohort. PARTICIPANTS: All pediatric (<19 years of age) residents of Olmsted County, Minnesota, diagnosed with an esodeviation (> or =10 prism diopters) from January 1, 1985, through December 31, 1994. METHODS: The medical records of all potential patients identified by the resources of the Rochester Epidemiology Project were reviewed. MAIN OUTCOME MEASURES: Incidence and types of childhood esotropia. RESULTS: Three hundred eighty-five cases of childhood esotropia were identified during the 10-year period, yielding an annual age- and gender-adjusted incidence of 111.0 (95% confidence interval, 99.9-122.1) per 100,000 patients younger than 19 years of age. This rate corresponds to a cumulative prevalence of approximately 2.0% of all children younger than 6 years, with a significant decrease in older ages (P<0.0001). Of the 385 study children, the specific forms and percentages of esotropia diagnosed were as follows: fully accommodative, 140 (36.4%); acquired nonaccommodative, 64 (16.6%); esotropia associated with an abnormal central nervous system, 44 (11.4%); partially accommodative, 39 (10.1%); congenital, 31 (8.1%); sensory, 25 (6.5%); paralytic, 25 (6.5%); undetermined, 13 (3.4%); and other, 4 (1.0%). CONCLUSIONS: The incidence of childhood esotropia from this self-referred population-based study is comparable with prevalence rates reported among Western populations. Esotropia is most common during the first decade of life, with the accommodative and acquired nonaccommodative forms occurring most frequently. The congenital, sensory, and paralytic forms of childhood esotropia were less common in this population.

Risk of retinal detachment after cataract extraction, 1980-2004: a population-based study.

PURPOSE: To estimate the long-term cumulative risk of retinal detachment (RD) after cataract extraction (CE). DESIGN: Retrospective cohort study and nested case-control study. PARTICIPANTS: All residents of Olmsted County, Minnesota who had CE from 1980 through 2004 (10 256 CEs in 7137 residents) and were diagnosed subsequently with RD in the same period. Two controls chosen from the primary cataract surgery cohort were matched to each RD case by age, gender, and duration of follow-up. METHODS: Cases were identified through the Rochester Epidemiology Project databases. Records were reviewed to confirm case status and ascertain risk factor information. The observed probability of RD after CE was estimated using the Kaplan-Meier method. A cumulative probability ratio of RD after CE was determined by comparing the observed probability of RD and the expected probability of RD in residents without CE. Logistic regression models assessed differences between cases and controls. MAIN OUTCOME MEASURES: Probability of and risk factors associated with RD after CE. RESULTS: Eighty-two cases of RD were identified. The cumulative probability of RD increased in a nearly linear manner over the 25-year study period. At 1, 5, 10, 15, and 20 years after extracapsular CE (ECCE) and phacoemulsification, cumulative probabilities of RD were 0.27%, 0.71%, 1.23%, 1.58%, and 1.79%, respectively. There was no significant difference in the probability of RD after ECCE when compared with phacoemulsification (P = 0.13). The cumulative probability ratio of RD at 20 years after ECCE and phacoemulsification remained 4.0-fold (95% confidence interval, 2.6-5.4) higher than would be expected in a similar group of residents not undergoing CE (P<0.001). Male gender, younger age, myopia, increased axial length, and posterior capsular tear were associated significantly with RD (P<0.01). CONCLUSIONS: The cumulative risk of RD after ECCE and phacoemulsification is increased for up to 20 years after surgery.

Incidence and types of childhood hypertropia: a population-based study.

OBJECTIVE: To determine the incidence and types of childhood hypertropia in a defined population. DESIGN: Retrospective population-based cohort. PARTICIPANTS: All pediatric (<19 years of age) residents of Olmsted County, Minnesota, diagnosed with vertical strabismus from January 1, 1985, through December 31, 1994. METHODS: The medical records of all potential patients identified by the resources of the Rochester Epidemiology Project were reviewed. MAIN OUTCOME MEASURES: Incidence and types of childhood hypertropia. RESULTS: Forty-two cases of childhood hypertropia were identified during the 10-year period, yielding an annual age- and gender-adjusted incidence of 12.9 (95% confidence interval, 9.0-16.9) per 100000 patients younger than 19 years of age. This rate corresponds to a prevalence of approximately 0.26%, or 1 in 391, of all children younger than 19 years of age. Nearly three fourths (71.4%) of the children had a IVth cranial nerve palsy, primary inferior oblique overaction, Brown syndrome, or a vertical tropia in the setting of an abnormal central nervous system. CONCLUSIONS: The incidence rates for childhood hypertropia in this population-based study are higher than published reports of prevalence. Fourth cranial nerve palsy and primary dysfunction of the inferior oblique muscle were the most common forms of vertical strabismus in this population.

Association of anthropometric measures with the presence and progression of benign prostatic hyperplasia.

The authors investigated the association of anthropometric measures with the presence and progression of components of benign prostatic hyperplasia (BPH) and a clinical outcome of BPH in a cohort of healthy, Caucasian men aged 40-79 years that was randomly selected from the Olmsted County, Minnesota, population beginning in 1990. Exclusionary criteria included prostate or bladder surgery, urethral surgery or stricture, or medical or other neurologic conditions that could affect normal urinary function. Height, weight, and waist and hip circumferences were measured. Components of BPH, including American Urological Association Symptom Index scores, peak urinary flow rate, and prostate volume, were assessed on a randomly selected subsample. Acute urinary retention was assessed through review of community medical records. There were few significant associations of anthropometric measures with the presence or progression of components of BPH or clinical outcome of BPH, and there were no instances where the point estimates for the BPH components suggested a dose-response effect. The authors conclude that anthropometric measures are not significantly associated with the presence or progression of BPH as measured by American Urological Association Symptom Index scores, peak urinary flow rate, prostate volume, or acute urinary retention. These data provide no evidence of a consistent significant relation between anthropometric measures and BPH.