Virginia Pate

Lifetime risk of stress urinary incontinence or pelvic organ prolapse surgery.

OBJECTIVE: To estimate the lifetime risk of stress urinary incontinence (SUI) surgery, pelvic organ prolapse (POP) surgery, or both using current, population-based surgical rates from 2007 to 2011. METHODS: We used a 2007–2011 U.S. claims and encounters database. We included women aged 18–89 years and estimated age-specific incidence rates and cumulative incidence (lifetime risk) of SUI surgery, POP surgery, and either incontinence or prolapse surgery with 95% confidence intervals (CIs). We estimated lifetime risk until the age of 80 years to be consistent with prior studies. RESULTS: From 2007 to 2011, we evaluated 10,177,480 adult women who were followed for 24,979,447 person-years. Among these women, we identified 65,397 incident, or first, SUI and 57,755 incident prolapse surgeries. Overall, we found that the lifetime risk of any primary surgery for SUI or POP was 20.0% (95% CI 19.9–20.2) by the age of 80 years. Separately, the cumulative risk for SUI surgery was 13.6% (95% CI 13.5–13.7) and that for POP surgery was 12.6% (95% CI 12.4–2.7). For age-specific annual risk, SUI demonstrated a bimodal peak at age 46 years and then again at age 70–71 years with annual risks of 3.8 and 3.9 per 1,000 women, respectively. For POP, the risk increased progressively until ages 71 and 73 years when the annual risk was 4.3 per 1,000 women. CONCLUSION: Based on a U.S. claims and encounters database, the estimated lifetime risk of surgery for either SUI or POP in women is 20.0% by the age of 80 years. LEVEL OF EVIDENCE: III

Trends in use of surgical mesh for pelvic organ prolapse.

OBJECTIVE Limited data exist on the rates of pelvic organ prolapse procedures utilizing mesh. The objective of this study was to examine trends in vaginal mesh prolapse procedures (VMs), abdominal sacrocolpopexy (ASC), and minimally invasive sacrocolpopexy (MISC) from 2005 to 2010. STUDY DESIGN We utilized deidentified, adjudicated health care claims data from across the United States from 2005 to 2010. Among women 18 years old or older, we identified all mesh prolapse procedures based on current procedural terminology codes (57267 for VM, 57280 for ASC, and 57425 for MISC). VM procedures included all vaginal prolapse surgeries in which mesh was placed, whether in the anterior, apical, or posterior compartment. We estimated rates per 100,000 person-years (100,000 py) and 95% confidence intervals (CIs). RESULTS During 78.5 million person-years of observation, we identified 60,152 mesh prolapse procedures, for a rate of 76.0 per 100,000 py (95% CI, 73.6-78.5). Overall, VMs comprised 74.9% of these surgeries for an overall rate of 56.9 per 100,000 py (95% CI, 55.0-58.9). Rates of ASC and MISC were considerably lower at 12.0 per 100,000 py (95% CI, 11.6-12.5) and 9.5 per 100,000 py (95% CI, 9.2-9.9), respectively. Among sacrocolpopexies, ASC was more common than MISC in 2005-2007; however, since 2007, the rate of MISC has increased, whereas the rate of ASC has decreased. Regarding trends by age, VM was considerably more common than sacrocolpopexies at all ages, and ASC was more common than MISC in women older than 50 years. CONCLUSION From 2005 to 2010, the rate of mesh prolapse procedures has increased, with vaginal mesh surgeries constituting the vast majority.

Antidepressant Dose, Age, and the Risk of Deliberate Self-harm

IMPORTANCE A comprehensive meta-analysis of randomized trial data suggests that suicidal behavior is twice as likely when children and young adults are randomized to antidepressants compared with when they are randomized to placebo. Drug-related risk was not elevated for adults older than 24 years. To our knowledge, no study to date has examined whether the risk of suicidal behavior is related to antidepressant dose, and if so, whether risk depends on a patients age. OBJECTIVE To assess the risk of deliberate self-harm by antidepressant dose, by age group. DESIGN, SETTING, AND PARTICIPANTS This was a propensity score-matched cohort study using population-based health care utilization data from 162,625 US residents with depression ages 10 to 64 years who initiated antidepressant therapy with selective serotonin reuptake inhibitors at modal or at higher than modal doses from January 1, 1998, through December 31, 2010. MAIN OUTCOMES AND MEASURES International Classification of Diseases, Ninth Revision (ICD-9) external cause of injury codes E950.x-E958.x (deliberate self-harm). RESULTS The rate of deliberate self-harm among children and adults 24 years of age or younger who initiated high-dose therapy was approximately twice as high as among matched patients initiating modal-dose therapy (hazard ratio [HR], 2.2 [95% CI, 1.6-3.0]), corresponding to approximately 1 additional event for every 150 such patients treated with high-dose (instead of modal-dose) therapy. For adults 25 to 64 years of age, the absolute risk of suicidal behavior was far lower and the effective risk difference null (HR, 1.2 [95% CI, 0.8-1.9]). CONCLUSIONS AND RELEVANCE Children and young adults initiating therapy with antidepressants at high-therapeutic (rather than modal-therapeutic) doses seem to be at heightened risk of deliberate self-harm. Considered in light of recent meta-analyses concluding that the efficacy of antidepressant therapy for youth seems to be modest, and separate evidence that antidepressant dose is generally unrelated to therapeutic efficacy, our findings offer clinicians an additional incentive to avoid initiating pharmacotherapy at high-therapeutic doses and to closely monitor patients starting antidepressants, especially youth, for several months.

Sling revision/removal for mesh erosion and urinary retention: long-term risk and predictors

OBJECTIVE The objective of the study was to estimate the long-term risk of sling revision/removal after an initial sling and to assess indications (mesh erosion and urinary retention) and predictors of sling revision/removal. STUDY DESIGN Using a population-based cohort of commercially insured individuals, we identified women 18 years old or older who underwent a sling (Current Procedural Terminology code 57288) between 2001 and 2010 and any subsequent sling revision/removal (Current Procedural Terminology code 57287). We estimated the cumulative risk of revision/removal annually and evaluated predictors of sling revision/removal using Kaplan-Meier survival curves and Cox proportional hazards models, respectively. RESULTS We identified 188,454 eligible women who underwent an index sling. The 9 year cumulative risk of sling revision/removal was 3.7% (95% confidence interval [CI], 3.5-3.9). At 1 year, this risk was already 2.2% and then increased to 3.2% at 4 years before plateauing. With regard to the indication for the sling revision/removal, a greater proportion was due to mesh erosion compared with urinary retention, with a 9 year risk of 2.5% (95% CI, 2.3-2.6) for mesh erosion vs 1.3% (95% CI, 1.2-1.4) for urinary retention. Age had an effect on the revision/removal rates for both mesh erosion and urinary retention, with the higher risks among those aged 18-29 years. The risk of revision/removal for mesh erosion and urinary retention was also elevated among women who had a concomitant anterior or apical prolapse procedure. CONCLUSION In this population-based analysis, the 9 year risk of sling revision/removal was relatively low at 3.7%, with 60% of revisions/removals caused by mesh erosion.

Dipeptidyl-peptidase-4 inhibitors and pancreatic cancer: a cohort study

To compare pancreatic cancer incidence and diagnostic evaluation among patients initiating dipeptidyl‐peptidase‐4 (DPP‐4) inhibitor treatment with those initiating sulfonylureas (SU) and thiazolidinediones (TZD).

Completeness of prescription information in US commercial claims databases

Pharmacy commercial claims databases are widely used for pharmacoepidemiologic research. However, concerns have been raised that these databases may not fully capture claims for generic medications as a result of patients filling outside the context of their insurance. This has implications for many research activities and quality improvement programs. We sought to estimate the percentage of missing prescriptions in US commercial claims data using a novel design.

Effect of Statin Use on Acute Kidney Injury Risk Following Coronary Artery Bypass Grafting

Acute kidney injury (AKI) is a serious complication of cardiovascular surgery. Although some nonexperimental studies suggest that statin use may reduce postsurgical AKI, methodologic differences in study designs leave uncertainty regarding the reality or magnitude of the effect. The aim of this study was to estimate the effect of preoperative statin initiation on AKI after coronary artery bypass grafting (CABG) using an epidemiologic approach more closely simulating a randomized controlled trial in a large CABG patient population. Health care claims from large, employer-based and Medicare insurance databases for 2000 to 2010 were used. To minimize healthy user bias, patients were identified who underwent nonemergent CABG who either newly initiated a statin <20 days before surgery or were unexposed for ≥200 days before CABG. AKI was identified <15 days after CABG. Multivariate-adjusted risk ratios (RRs) and 95% confidence intervals (CIs) were calculated using Poisson regression. Analyses were repeated using propensity score methods adjusted for clinical and health care utilization variables. A total of 17,077 CABG patients were identified. Post-CABG AKI developed in 3.4% of statin initiators and 6.2% of noninitiators. After adjustment, a protective effect of statin initiation on AKI was observed (RR 0.78, 95% CI 0.63 to 0.96). This effect differed by age, with an RR of 0.91 (95% CI 0.68 to 1.20) for patients aged ≥65 years and an RR of 0.62 (95% CI 0.45 to 0.86) for those aged <65 years, although AKI was more common in the older group (7.7% vs 4.0%). In conclusion, statin initiation immediately before CABG may modestly reduce the risk for postoperative AKI, particularly in younger CABG patients.

Using Claims Data to Predict Dependency in Activities of Daily Living as a Proxy for Frailty

Estimating drug effectiveness and safety among older adults in population‐based studies using administrative health care claims can be hampered by unmeasured confounding as a result of frailty. A claims‐based algorithm that identifies patients likely to be dependent, a proxy for frailty, may improve confounding control. Our objective was to develop an algorithm to predict dependency in activities of daily living (ADL) in a sample of Medicare beneficiaries.

Cancer Incidence Among Those Initiating Insulin Therapy With Glargine Versus Human NPH Insulin

OBJECTIVE To add to the evidence on comparative long-term effects of insulin analog glargine versus human NPH insulin on the risk for cancer. RESEARCH DESIGN AND METHODS We identified cohorts of initiators of glargine and human NPH without an insulin prescription during the prior 19 months among patients covered by the Inovalon Medical Outcomes Research for Effectiveness and Economics Registry (MORE2 Registry) between January 2003 and December 2010. Patients were required to have a second prescription of the same insulin within 180 days and to be free of cancer. We balanced cohorts on risk factors for cancer outcomes based on comorbidities, comedication, and health care use during the prior 12 months using inverse probability of treatment weighting. Incident cancer was defined as having two claims for cancer (any cancer) or the same cancer (breast, prostate, colon) within 2 months. We estimated adjusted hazard ratios (HRs) and their 95% CI using weighted Cox models censoring for stopping, switching, or augmenting insulin treatment, end of enrollment, and mortality. RESULTS More patients initiated glargine (43,306) than NPH (9,147). Initiators of glargine (NPH) were followed for 1.2 (1.1) years and 50,548 (10,011) person-years; 993 (178) developed cancer. The overall HR was 1.12 (95% CI 0.95–1.32). Results were consistent for breast cancer, prostate cancer, and colon cancer; various durations of treatment; and sensitivity analyses. CONCLUSIONS Patients initiating insulin glargine rather than NPH do not seem to be at an increased risk for cancer. While our study contributes significantly to our evidence base for long-term effects, this evidence is very limited mainly based on actual dynamics in insulin prescribing.

Patterns of rotavirus vaccine uptake and use in privately-insured US infants, 2006-2010.

Rotavirus vaccines are highly effective at preventing gastroenteritis in young children and are now universally recommended for infants in the US. We studied patterns of use of rotavirus vaccines among US infants with commercial insurance. We identified a large cohort of infants in the MarketScan Research Databases, 2006–2010. The analysis was restricted to infants residing in states without state-funded rotavirus vaccination programs. We computed summary statistics and used multivariable regression to assess the association between patient-, provider-, and ecologic-level variables of rotavirus vaccine receipt and series completion. Approximately 69% of 594,117 eligible infants received at least one dose of rotavirus vaccine from 2006–2010. Most infants received the rotavirus vaccines at the recommended ages, but more infants completed the series for monovalent rotavirus vaccine than pentavalent rotavirus vaccine or a mix of the vaccines (87% versus 79% versus 73%, P<0.001). In multivariable analyses, the strongest predictors of rotavirus vaccine series initiation and completion were receipt of the diphtheria, tetanus and acellular pertussis vaccine (Initiation: RR = 7.91, 95% CI = 7.69–8.13; Completion: RR = 1.26, 95% CI = 1.23–1.29), visiting a pediatrician versus family physician (Initiation: RR = 1.51, 95% CI = 1.49–1.52; Completion: RR = 1.13, 95% CI = 1.11–1.14), and living in a large metropolitan versus smaller metropolitan, urban, or rural area. We observed rapid diffusion of the rotavirus vaccine in routine practice; however, approximately one-fifth of infants did not receive at least one dose of vaccine as recently as 2010. Interventions to increase rotavirus vaccine coverage should consider targeting family physicians and encouraging completion of the vaccine series.