Jeff M. Slezak

Correlates for Completion of 3-Dose Regimen of HPV Vaccine in Female Members of a Managed Care Organization

OBJECTIVE To examine the rate and correlates of completion of the quadrivalent human papillomavirus vaccine (HPV4) 3-dose regimen because nonadherence to the regimen may adversely affect vaccine efficacy. PARTICIPANTS AND METHODS Female members of Kaiser Permanente Southern California who were 9 to 26 years old, received the first dose of HPV4 between October 2006 and March 2007, and maintained health plan membership 12 months afterward were identified and followed up for regimen completion. We examined the following: (1) demographics/socioeconomic status, (2) primary care physician characteristics, (3) historical health service utilization, (4) womens health-related conditions, and (5) selected immune-related conditions for their association with completion in 2 age groups: 9 to 17 years and 18 to 26 years. Multivariable log-binomial regression was used to directly estimate relative risk (RR). RESULTS Of the 34,193 females who initiated HPV4, the completion rate was 41.9% in the 9- to 17-year-old group and 47.1% in the 18- to 26-year-old group. Black race (RR, 0.70; 95% confidence interval [CI], 0.64-0.77) and lower neighborhood education level were associated with lower regimen completion. However, those in the 9- to 17-year-old group who were covered by the state-subsidized program Medi-Cal were more likely to complete the regimen (RR, 1.14; 95% CI, 1.07-1.22). Historical hospitalizations and emergency department visits (RR, 0.92; 95% CI, 0.87-0.96; and RR, 0.96; 95% CI, 0.94-0.98 per visit, respectively) and having a pediatrician were also predictors of noncompletion. A history of sexually transmitted diseases, abnormal Papanicolaou test results, and immune-related conditions (eg, asthma/infections) were not associated with regimen completion. CONCLUSION These findings suggest that factors such as race or socioeconomic status should be considered when human papillomavirus vaccination programs are being designed and evaluated.

Stratifying Risk of Urinary Tract Malignant Tumors in Patients With Asymptomatic Microscopic Hematuria

OBJECTIVEnTo identify patients who could safely avoid unnecessary radiation and instrumentation after the detection of microscopic hematuria.nnnPATIENTS AND METHODSnWe conducted a prospective cohort study of patients who were referred to urologists and underwent a full evaluation for asymptomatic microscopic hematuria during a 2-year period in an integrated care organization in 3 regions along the West Coast of the United States. A test cohort and validation cohort of patients with hematuria evaluations between January 9, 2009, and August 15, 2011, were identified. Patients were followed passively through their electronic health records for a diagnosis of urothelial or renal cancer. The degree of microscopic hematuria, history of gross hematuria, smoking history, age, race, imaging findings, and cystoscopy findings were evaluated as risk factors for malignant tumors.nnnRESULTSnThe test cohort consisted of 2630 patients, of whom 55 (2.1%) had a neoplasm detected and 50 (1.9%) had a pathologically confirmed urinary tract cancer. Age of 50 years or older and a recent diagnosis of gross hematuria were the strongest predictors of cancer. Male sex was also predictive of cancer, whereas smoking history and 25 or more red blood cells per high-power field on a recent urinalysis were not statistically significant. A Hematuria Risk Index developed from these factors had an area under the receiver operating characteristic curve of 0.809. In the validation cohort of 1784 patients, the Hematuria Risk Index performed comparably (area under the curve = 0.829). Overall, 32% of the population was identified as low risk and 0.2% had a cancer detected; 14% of the population was identified as high risk, of whom 11.1% had a cancer found.nnnCONCLUSIONnThese results suggest that a considerable proportion of patients could avoid extensive evaluations with the use of the Hematuria Risk Index.

Association of Hematuria on Microscopic Urinalysis and Risk of Urinary Tract Cancer

PURPOSEnWe determined the incidence of urinary tract cancer in patients with hematuria, stratified risk by age, gender and hematuria degree, and examined current best policy recommendations.nnnMATERIALS AND METHODSnWe performed a large, retrospective population based cohort study of patients who underwent microscopic urinalysis during 2004 and 2005 in a large managed care organization. Patients were followed for 3 years for urinary tract cancer.nnnRESULTSnWe identified 772,002 patients who underwent urinalysis during the study period. After exclusions due to previous hematuria, age less than 18 years, pregnancy, urinary tract infection, inpatient status and prior urinary tract cancer 309,402 patients were available for analysis, of whom 156,691 had hematuria. The overall 3-year incidence of urinary tract cancer in those with hematuria was 0.68%. Older age (greater than 40 years OR 17.0, 95% CI 11.2-25.7), greater hematuria (greater than 25 red blood cells per high power field OR 4.0, 95% CI 3.5-4.5) and male gender (OR 4.8, 95% CI 4.2-5.6) were associated with a higher risk of cancer. The American Urological Association definition of microhematuria had 50% sensitivity, 84% specificity and 1.3% positive predictive value.nnnCONCLUSIONSnThe incidence of urinary tract cancer is low even in individuals with microhematuria. Thus, current best policy recommendations do not perform well. Since older age, male gender and greater hematuria are associated with a higher risk of cancer, future studies should evaluate strategies that target these populations.

Extracting data from electronic medical records: validation of a natural language processing program to assess prostate biopsy results

ObjectiveThe extraction of specific data from electronic medical records (EMR) remains tedious and is often performed manually. Natural language processing (NLP) programs have been developed to identify and extract information within clinical narrative text. We performed a study to assess the validity of an NLP program to accurately identify patients with prostate cancer and to retrieve pertinent pathologic information from their EMR.Materials and methodsA retrospective review was performed of a prospectively collected database including patients from the Southern California Kaiser Permanente Medical Region that underwent prostate biopsies during a 2-week period. A NLP program was used to identify patients with prostate biopsies that were positive for prostatic adenocarcinoma from all pathology reports within this period. The application then processed 100 consecutive patients with prostate adenocarcinoma to extract 10 variables from their pathology reports. The extraction and retrieval of information by NLP was then compared to a blinded manual review.ResultsA consecutive series of 18,453 pathology reports were evaluated. NLP correctly detected 117 out of 118 patients (99.1xa0%) with prostatic adenocarcinoma after TRUS-guided prostate biopsy. NLP had a positive predictive value of 99.1xa0% with a 99.1xa0% sensitivity and a 99.9xa0% specificity to correctly identify patients with prostatic adenocarcinoma after biopsy. The overall ability of the NLP application to accurately extract variables from the pathology reports was 97.6xa0%.ConclusionsNatural language processing is a reliable and accurate method to identify select patients and to extract relevant data from an existing EMR in order to establish a prospective clinical database.

A Randomized Intervention of Reminder Letter for Human Papillomavirus Vaccine Series Completion

PURPOSEnCompletion rate for the three-dose series of the human papillomavirus (HPV) vaccine has generally been low. This study evaluated the effectiveness of a reminder letter intervention on HPV vaccine three-dose series completion.nnnMETHODSnFemale members of Kaiser Permanente Southern California Health Plan who received at least one dose, but not more than two doses, of the HPV vaccine by February 13, 2013, and who were between ages 9 and 26 years at the time of first HPV vaccination were included. Eighty percent of these females were randomized to receive the reminder letter, and 20% were randomized to receive standard of care (control). The reminder letters were mailed quarterly to those who had not completed the series. The proportion of series completion at the end of the 12-month evaluation period was compared using chi-square test.nnnRESULTSnA total of 9,760 females were included in the intervention group and 2,445 in the control group. HPV vaccine series completion was 56.4% in the intervention group and 46.6% in the control groups (p < .001). The effect of the intervention appeared to be stronger in girls aged 9-17xa0years compared with young women aged 18-26xa0years at the first dose and in blacks compared with whites.nnnCONCLUSIONSnReminder letters scheduled quarterly were effective to enhance HPV vaccine series completion among those who initiated the vaccine. However, a large gap in series completion remained despite the intervention. Future studies should address other barriers to series completion, including those at the providers and the health care system level.

Validation of Pediatric Diabetes Case Identification Approaches for Diagnosed Cases by Using Information in the Electronic Health Records of a Large Integrated Managed Health Care Organization

We explored the utility of different algorithms for diabetes case identification by using electronic health records. Inpatient and outpatient diagnosis codes, as well as data on laboratory results and dispensing of antidiabetic medications were extracted from electronic health records of Kaiser Permanente Southern California members who were less than 20 years of age in 2009. Diabetes cases were ascertained by using the SEARCH for Diabetes in Youth Study protocol and comprised the gold standard. Sensitivity, specificity, positive and negative predictive values, accuracy, and the area under the receiver operating characteristic curve (AUC) were compared in 1,000 bootstrapped samples. Based on data from 792,992 youth, of whom 1,568 had diabetes (77.2%, type 1 diabetes; 22.2%, type 2 diabetes; 0.6%, other), case identification accuracy was highest in 75% of bootstrapped samples for those who had 1 or more outpatient diabetes diagnoses or 1 or more insulin prescriptions (sensitivity, 95.9%; positive predictive value, 95.5%; AUC, 97.9%) and in 25% of samples for those who had 2 or more outpatient diabetes diagnoses and 1 or more antidiabetic medications (sensitivity, 92.4%; positive predictive value, 98.4%; AUC, 96.2%). Having 1 or more outpatient type 1 diabetes diagnoses (International Classification of Diseases, Ninth Revision, Clinical Modification, code 250.x1 or 250.x3) had the highest accuracy (94.4%) and AUC (94.1%) for type 1 diabetes; the absence of type 1 diabetes diagnosis had the highest accuracy (93.8%) and AUC (93.6%) for identifying type 2 diabetes. Information in the electronic health records from managed health care organizations provides an efficient and cost-effective source of data for childhood diabetes surveillance.

Population-based study of erectile dysfunction and polypharmacy

Study Type – Symptom prevalence (population cohort)

An unmasking phenomenon in an observational post-licensure safety study of adolescent girls and young women.

Our recent experience in a post-licensure safety study of autoimmune conditions following the quadrivalent human papillomavirus vaccine in 189,629 girls and young women ages 9-26 years led us to question the adequacy of the exclusion of Day 0 events to prevent the erroneous association of prevalent conditions with vaccination. Of the 18 confirmed cases of Graves disease diagnosed in days 1-60 following vaccination, only 6 cases appeared to be truly new onset. Among the remaining 12 cases, 2 cases had abnormal thyroid stimulating hormone or thyroxine labs drawn prior to or on Day 0 but had no documented pre-existing symptoms. The other 10 cases had mention of symptoms of hyperthyroidism referencing a period prior to first HPV-4 dose. This unmasking phenomenon, due to health care visits that include vaccination and new workups of preexisting symptoms, may not be adequately controlled through the exclusion of Day 0 events.

The Kaiser Permanente experience with ultrasound-guided percutaneous endovascular abdominal aortic aneurysm repair.

BACKGROUNDnThis study was conducted to determine the effect of ultrasound (US)-guided percutaneous access for percutaneous endovascular abdominal aortic aneurysm repair (PEVAR) on conversion to open repair by femoral cutdown. We also sought to identify other risk factors associated with failure of percutaneous access and conversion to femoral cutdowns.nnnMETHODSnThis is a single-center, retrospective review of 101 patients who underwent PEVAR between January 1, 2005 and July 31, 2009 (56 months). Risk factors that were evaluated for unsuccessful PEVAR included gender, age (≤65 and ≥66 years), US-guided percutaneous access, mechanical failure, abdominal aortic aneurysm size, and the following comorbidities: diabetes, hypertension, vessel calcification, and obesity (body mass index: ≥30 kg/m(2)).nnnRESULTSnThere were 10 (9.9%) conversions from percutaneous to femoral cutdown, yielding a success rate of 90.1% for a total percutaneous approach. Each converted patient had one groin converted, resulting in a cutdown rate per groin of 10/202 (5%). There were no 30-day mortalities. Univariate analysis showed that hypertension (P = 0.261), age ≥66 years (P = 0.741), current smoking history (P = 0.649), past smoking history (P = .093), diabetes (P = 0.908), vessel calcification (P = 0.8281), and body mass index ≥30 kg/m(2) (P = 0.052) did not significantly predict conversion to endovascular aortic aneurysm repair (EVAR). Mechanical failure significantly predicted conversion to cutdown EVAR (P = 0.0002), whereas US-guided percutaneous access influenced successful PEVAR (P = 0.030). Multivariate analysis showed that mechanical failure significantly predicted conversion to cutdown EVAR (P = 0.003) and US-guided percutaneous access influenced successful PEVAR (P = 0.040) after adjusting for smoking history and obesity.nnnCONCLUSIONnPEVAR is a viable option for aortic aneurysm repair that may be improved with US-guided percutaneous access by reducing the rate of femoral cutdowns.

Clinical effectiveness of pneumococcal polysaccharide vaccine in men: California Men's Health Study

OBJECTIVEnTo examine the effectiveness of pneumococcal polysaccharide vaccine (PPV) among approximately 40,000 community-dwelling men aged 45 years and older in the California Mens Health Study (CMHS) cohort.nnnMETHODSnAll participants completed an extensive questionnaire at baseline (2002-2003) and were followed for the occurrence of invasive pneumococcal disease (IPD) or all-cause pneumonia hospitalization through the end of 2009. Immunization status and incident IPD and pneumonia cases were ascertained through electronic medical records. The associations between vaccination and IPD or pneumonia hospitalization were assessed using time-dependent Cox proportional models to account for sociodemographics, time-updated vaccination status, and comorbidities.nnnRESULTSnThe median follow-up period of the 39,222 participants was 7.3 years. Among them, 11,902 (30.3%) had received at least one PPV vaccine at baseline and 7653 (19.5%) received their first PPV vaccine during the follow-up. There were 17 pneumococcal bacteremia cases, 647 hospitalized pneumonia cases, and no pneumococcal meningitis cases. The results suggested a reduced risk of pneumococcal bacteremia among men vaccinated at age ≥65 (adjusted hazard ratio [HR]: 0.35; 95% confidence interval [CI]: 0.06-1.91; p=0.22). PPV vaccination did not show a protective effect against all-cause pneumonia hospitalization (adjusted HR: 1.18; 95% CI: 1.02-1.37, p=0.03) among men vaccinated before 65 years old, but a moderate protective effect was suggested among men without chronic obstructive pulmonary diseases who were vaccinated after 65 years old (adjusted HR: 0.84; 95% CI: 0.67-1.06, p=0.15).nnnCONCLUSIONSnThe findings in this large cohort of men in Southern California suggested a benefit of PPV for protection against pneumococcal bacteremia among men vaccinated at age 65 years and older. PPV might not provide adequate protection against all-cause pneumonia hospitalization among men.