Richard Contreras

Parity, Mode of Delivery, and Pelvic Floor Disorders

OBJECTIVE: This study aimed to assess the associations between parity, mode of delivery, and pelvic floor disorders. METHODS: The prevalence of pelvic organ prolapse, stress urinary incontinence, overactive bladder, and anal incontinence was assessed in a random sample of women aged 25–84 years by using the validated Epidemiology of Prolapse and Incontinence Questionnaire. Women were categorized as nulliparous, vaginally parous, or only delivered by cesarean. Adjusted odds ratios and 95% confidence intervals (CIs) for each disorder were calculated with logistic regression, controlling for age, body mass index, and parity. RESULTS: In the 4,458 respondents the prevalence of each disorder was as follows: 7% prolapse, 15% stress urinary incontinence, 13% overactive bladder, 25% anal incontinence, and 37% for any one or more pelvic floor disorders. There were no significant differences in the prevalence of disorders between the cesarean delivery and nulliparous groups. The adjusted odds of each disorder increased with vaginal parity compared with cesarean delivery: prolapse = 1.82 (95% CI 1.04–3.19), stress urinary incontinence = 1.81 (95% CI 1.25–2.61), overactive bladder = 1.53 (95% CI 1.02–2.29), anal incontinence = 1.72 (95% CI 1.27–2.35), and any one or more pelvic floor disorders = 1.85 (95% CI 1.42–2.41). Number-needed-to-treat analysis revealed that 7 women would have to deliver only by cesarean delivery to prevent one woman from having a pelvic floor disorder. CONCLUSION: The risk of pelvic floor disorders is independently associated with vaginal delivery but not with parity alone. Cesarean delivery has a protective effect, similar to nulliparity, on the development of pelvic floor disorders when compared with vaginal delivery. LEVEL OF EVIDENCE: II-2

The influence of intrapartum antibiotics on the clinical spectrum of early-onset group B streptococcal infection in term infants.

Objective. The use of intrapartum antibiotics to prevent early-onset group B streptococcal (EOGBS) infection has left pediatricians in a quandary about the appropriate evaluation and treatment of infants at risk for this infection. The aim of this study was to determine whether intrapartum antibiotic prophylaxis changed the constellation and timing of onset of clinical signs of group B streptococcal (GBS) infection in term infants. Methodology. We conducted a retrospective chart review of infants who had EOGBS infection and were born in Southern California Kaiser Permanente Hospitals from 1988 through 1996. Objective criteria were used to ascertain maternal risk of infection, intrapartum antibiotic prophylaxis, and onset of clinical signs of infection. Results. Three hundred nineteen infants with EOGBS sepsis, bacteremia, or clinically suspected infection were identified from a population of 277 912 live births. Of the 172 term infants with culture-positive infection who had clinical signs of infection, 95% exhibited them in the first 24 hours of life. All of the infants exposed to intrapartum antibiotics became ill within the first 24 hours of life. Conclusions. Exposure to antibiotics during labor did not change the clinical spectrum of disease or the onset of clinical signs of infection within 24 hours of birth for term infants with EOGBS infection. A 48-hour stay is not required to monitor asymptomatic term infants exposed to intrapartum antibiotics for onset of GBS infection.

Glitazone Use Associated with Diabetic Macular Edema

PURPOSE To determine the ocular safety of glitazones in patients with diabetes, we investigated the association of diabetic macular edema (DME) in a large population of glitazone users. DESIGN Prospective cohort study. METHODS The study was conducted at Kaiser Permanente Southern California. About 170,000 persons with diabetes were identified using the Diabetes Case Identification Database. Glitazone drug use was obtained from the pharmacy database. The main outcome measure was the development of macular edema (ME). The chi2 test was used to compare proportions and t tests were used for means. Logistic regression analysis was used to adjust for potential confounding variables. RESULTS In 2006, there were 996 new cases of ME. Glitazone users were more likely to develop ME in 2006 (odds ratio [OR], 2.6; 95% confidence interval [CI], 2.4 to 3.0). After excluding patients who did not have the drug benefit, did not have an eye exam, and had a HgA1c <7.0, glitazone use was still associated with an increased risk of developing ME (OR, 1.6; 95% CI, 1.4 to 1.8). CONCLUSION The current study appears to show that the glitazone class of drug is associated with DME. After adjusting for confounding factors of age, glycemic control, and insulin use, glitazones are still modestly associated with DME. A more in-depth study will need to be done to evaluate the role of other confounding factors. When treating patients with DME, ophthalmologists should consider the role of the glitazones.

Fecal Immunochemical Test Program Performance Over 4 Rounds of Annual Screening: A Retrospective Cohort Study

Context The fecal immunochemical test is an effective way to screen for colorectal cancer, but we know more about how well it does the first time it is used and less about how well it does in later years with repeated testing. Contribution The researchers show that, after 4 years of repeated testing, patients continued to use the test and it continued to identify colorectal cancer. Caution This study did not measure whether identification of cancer changed outcomes. Implication The fecal immunochemical test is acceptable and effective for repeated testing. Colorectal cancer (CRC) is the second leading cause of cancer death in the United States (13), and screening with fecal occult blood tests (FOBTs) reduces CRC incidence and mortality (46). In randomized trials (711), annual or biennial guaiac-based FOBTs reduced CRC incidence by 17% to 20% and CRC mortality by 15% to 33%. Thus, the U.S. Preventive Services Task Force (4) and U.S. Multi-Society Task Force on Colorectal Cancer (12) recommend annual FOBT as an option for CRC screening for average-risk patients, defined as those aged 50 to 75 years with no history of CRC or adenoma, with no first-degree relatives with CRC, and who are not up to date with CRC screening according to other methods (that is, sigmoidoscopy within 5 years or colonoscopy within 10 years). Annual highly sensitive FOBTs are believed to be as effective as screening colonoscopy performed every 10 years if levels of adherence are high (13), although colonoscopy is recommended for those with a family history of CRC. Fecal blood tests are noninvasive and can be delivered by mail (14). In contrast to guaiac-based stool tests, fecal immunochemical test (FIT) screening can be done without dietary or medication restrictions, which allows it to achieve higher patient acceptance in organized CRC screening programs (15). This test also has higher detection rates for CRC and advanced adenomas than guaiac-based stool tests (1517). In a recent meta-analysis (18), the sensitivity of a single FIT application was 79% for CRC diagnosed within 2 years of testing; however, little is known about performance characteristics over several rounds of annual screening, particularly in community practice. The present study was conducted to evaluate FIT sensitivity for CRC and other performance characteristics over 4 rounds of annual testing in a U.S. community-based CRC screening program. Methods Study Population This retrospective longitudinal study was performed in a fixed cohort of Kaiser Permanente Northern California (KPNC) and Southern California (KPSC) health plan members. These integrated health care delivery organizations serve approximately 7 million persons in urban, suburban, and semirural regions throughout California. Kaiser Permanente health plan membership in California is diverse and similar in socioeconomic characteristics to the regions census demographics (1921). Study Oversight The study was approved by the institutional review boards of KPNC and KPSC, both of which waived the requirement for informed consent. The listed authors had sole responsibility for the study design, data collection, decision to submit the manuscript for publication, and drafting of the manuscript. This study was conducted within the National Cancer Institutefunded Population-based Research Optimizing Screening through Personalized Regimens (PROSPR) consortium, which conducts multisite, coordinated, transdisciplinary research to evaluate and improve cancer-screening processes. Organized CRC Screening Program The KPNC and KPSC initiated similar organized FIT screening programs between 2006 and 2008; the KPNC program has been described previously (14). Briefly, each year, the programs mail a FIT kit to eligible health plan members aged 50 to 75 years without a record of a colonoscopy within 10 years, sigmoidoscopy within 5 years, or fecal blood test within the prior year. The kit includes the FIT (OC FIT-CHEK; Polymedco), a standardized letter from the patients primary care provider, directions for completing and mailing the test, and a preprinted laboratory requisition order form. Outreach includes in-person, mail, secure e-mail, and telephone reminders as needed. The kits are returned by mail to regional laboratories and analyzed on or shortly after the return date using an OC-Sensor Diana automated system (Polymedco) with a cutoff level of 20 g of hemoglobin/g of buffer for a positive result. Patients with a positive FIT result are referred for follow-up colonoscopy. Study Eligibility Criteria and Participant Tracking The study cohort included CRC screening program participants aged 50 to 70 years on the date an initial kit was mailed to them in 2007 or 2008. Patients were excluded if they had been enrolled in the health plan for less than 1 year before the round 1 FIT mail date (to allow for the recording of prior out-of-system endoscopy procedures). They were also excluded if they were mailed a kit but subsequently had sigmoidoscopy or colonoscopy, were diagnosed with CRC, died, or terminated membership in the health plan before returning the initial FIT or within 1 year after their round 1 mail date if no FIT was returned. A total of 670841 health plan members was mailed the initial kit in 2007 or 2008 and met the study eligibility criteria; 323349 (48.2%) returned a FIT within 1 year after the mail date (Figure). The analytic cohort comprised these round 1 participants who were tracked from their baseline mail date (cohort entry) through up to 4 rounds of testing for mail dates; result dates; results (positive or negative); whether follow-up colonoscopy was performed within 1 year after a positive FIT result; and diagnoses of adenoma, adenoma with advanced histology, and CRC. Cohort members were followed for CRC through the follow-up screening rounds, even if they subsequently became ineligible for screening because of sigmoidoscopy or colonoscopy. Patients were censored at the time of CRC diagnosis, death, or termination of membership in the health plan if they did not rejoin. Figure. Study flow diagram.* The figure includes 1192 patients with CRC who were screened by FIT the year before diagnosis. Further, there were 118 additional patients with CRC diagnosed more than 1 y beyond the FIT screening date and 101 additional patients diagnosed with CRC who either crossed over to endoscopy in subsequent rounds or terminated health plan membership but then rejoined. CRC = colorectal cancer; FIT = fecal immunochemical test. * Shading indicates where patients were censored or became ineligible for subsequent FIT screening. Patients were eligible for the initial FIT mailing if they were aged 50 to 70 y and had 1 y of membership. See Methods section for exclusions. Number censored because of CRC and includes patients with CRC diagnosed within 1 y after their FIT result. Defining Annual Screening Episodes For each patient, the initial kit mail date in 2007 or 2008 was the anchor date for round 1 and for each subsequent round of testing. However, because subsequent mailing dates varied each round, mail dates within 3 months before to 12 months after each subsequent rounds anchor date were counted as having been distributed during that specific round. For example, a patient with a round 1 mail date of 15 March 2007 had subsequent anchor dates of 15 March for rounds 2 through 4 (2008, 2009, and 2010, respectively). If their next FIT was mailed on 15 January 2008, the test was considered to be distributed in round 2 because the second mail date occurred within 3 months of the round 2 anchor date. The FIT results recorded within 1 year of each mail date, and colonoscopies performed and adenomas or CRC diagnosed within 1 year after FIT results, were considered part of a single screening episode for the round when the FIT was distributed. Among round 1 participants, FITs with no recorded mail dates returned in rounds 2 through 4 were assumed to be distributed through in-reach methods (such as a clinic visit) and were counted in the follow-up round returned. In general, the first result per patient was counted in any given round. The earliest possible date of cohort entry (first mail date) was 1 January 2007, and the last possible date of follow-up was 31 December 2013 (12 months after the last possible FIT result date of 31 December 2012). Data Sources The FIT-related dates and results were obtained from the CRC screening program and laboratory databases for each region, respectively. Endoscopy procedures were identified using Current Procedural Terminology codes (22). Adenoma diagnoses used Systematized Nomenclature of Medicine codes. Prior validation studies have confirmed high levels of sensitivity and accuracy for capture of colonoscopy examinations and assignment of adenoma status (23). Colorectal adenocarcinomas and disease stage were obtained from the KPNC and KPSC cancer registries, which report to the SEER (Surveillance, Epidemiology, and End Results) registry. Cancer databases capture more than 98% of cancer diagnoses within the KPNC and KPSC populations. Advanced-stage cancer was defined as stage III (regional disease with spread to regional lymph nodes only) or stage IV (distant metastasis) according to the American Joint Committee on Cancer staging system; for patients who did not have such staging, advanced-stage cancer was defined as code 3 (disease in the regional lymph nodes), code 4 (regional disease with direct extension and spread to regional lymph nodes), or code 7 (distant metastasis) according to the SEER Program Coding and Staging Manual 2013 (24). Data Analysis The following performance characteristics were calculated for each round of screening and overall: 1) participation (percentage of eligible patients who were distributed and completed a FIT within 1 year of their mailing date), 2) FIT positivity (percentage of participants who completed FITs and had positive results), 3) follow-up colonoscopy (per

Surgical margins and survival after head and neck cancer surgery

BackgroundMixed results exist as to whether positive surgical margins impact survival. The aim of this study was to determine whether positive surgical margins are indeed associated with decreased survival in patients with primary head and neck cancer.MethodsWe conducted a retrospective cohort study of 261 cases diagnosed with cancer of the larynx or tongue between 1995 and 1999. Cases were followed through December 31, 2002. Survival curves by margin status were generated by Kaplan-Meier methods. Categorical data were evaluated with odds ratios (OR).ResultsAll-cause mortality was markedly higher in cases with positive margins as compared with those with negative margins (54% versus 29%, P = 0.005). This pattern also appeared after adjusting for age and sex (OR = 2.97, 95% CI: 1.29 – 6.84).ConclusionOur findings suggest that positive surgical margin status is associated with increased mortality. This association also generally persists after adjustment for tumor size, stage, and adjuvant therapy.

Comparative Effectiveness of Antibiotic Prophylaxis in Cataract Surgery.

PURPOSE Intracameral injection is an effective method for preventing infection, but no controlled study has been published in the United States. DESIGN We conducted an observational, longitudinal cohort study to examine the effect of topical and injected antibiotics on risk of endophthalmitis. PARTICIPANTS We identified 315 246 eligible cataract procedures in 204 515 members of Kaiser Permanente, California, 2005-2012. METHODS The study used information from the membership, medical, pharmacy, and surgical records from the electronic health record. MAIN OUTCOME MEASURES The adjusted odds ratio (OR) and 95% confidence interval (CI) for the association of antibiotic prophylaxis (route and agent) with risk of endophthalmitis was estimated using logistic regression analysis. RESULTS We confirmed 215 cases of endophthalmitis (0.07% or 0.7/1000). Posterior capsular rupture was associated with a 3.68-fold increased risk of endophthalmitis (CI, 1.89-7.20). Intracameral antibiotic was more effective than topical agent alone (OR, 0.58; CI, 0.38-0.91). Combining topical gatifloxacin or ofloxacin with intracameral agent was not more effective than using an intracameral agent alone (compared with intracameral only: intracameral plus topical, OR, 1.63; CI, 0.48-5.47). Compared with topical gatifloxacin, prophylaxis using topical aminoglycoside was ineffective (OR, 1.97; CI, 1.17-3.31). CONCLUSIONS Surgical complication remains a key risk factor for endophthalmitis. Intracameral antibiotic was more effective for preventing post-cataract extraction endophthalmitis than topical antibiotic alone. Topical antibiotic was not shown to add to the effectiveness of an intracameral regimen.

Racial/Ethnic Differences in the Prevalence of Atrial Fibrillation Among Older Adults—A Cross-Sectional Study

BACKGROUND Atrial fibrillation affects 4% to 8% of individuals over 60 years of age based on studies of predominantly white populations, whether this is true among nonwhite individuals is not clear. This study was undertaken to define racial/ethnic differences in atrial fibrillation prevalence among a large community cohort. METHODS This is a cross-sectional study. In 2008, there were 430,317 members aged 60 years or older in a large California health maintenance organization. By searching International Classification of Diseases, Ninth Revision codes and electronic electrocardiographic archives, we identified all members in this age group with primary, nonvalvular atrial fibrillation. Race/ethnicity data were assigned using health plan enrollment, service utilization, Asian/Hispanic surname and geocoding methods, and was available for 80.5% of members (79.8% of non-atrial fibrillation and 92% of atrial fibrillation), 99% of which were white, black, Asian, or Hispanic. We assessed the age- and gender-specific atrial fibrillation prevalence rates for each racial/ethnic group. The effect of race/ethnicity on atrial fibrillation was analyzed with logistic regression methods adjusting for potential confounders. RESULTS The overall atrial fibrillation prevalence was 5.3%. Among members with assigned race/ethnicity data, the prevalence among whites, blacks, Asians, and Hispanics was 8.0%, 3.8%, 3.9%, and 3.6%, respectively. The adjusted odds ratios (95% confidence intervals) of atrial fibrillation among blacks, Asians, and Hispanics with whites as referent were 0.49 (0.47-0.52), 0.68 (0.64-0.72), and 0.58 (0.55-0.61), respectively. CONCLUSIONS Atrial fibrillation is less prevalent in older nonwhite individuals than whites. White race/ethnicity is associated with significantly greater odds for atrial fibrillation compared to blacks, Asians, and Hispanics, after adjusting for comorbidities associated with the development of atrial fibrillation.

Race and Ethnicity Data Quality and Imputation Using U.S. Census Data in an Integrated Health System: The Kaiser Permanente Southern California Experience

Research on racial and ethnic disparities using health system databases can shed light on the usual health care and outcomes of large numbers of individuals so that health inequities can be better understood and addressed. Such research often suffers from limitations in race/ethnicity data quality. We examined the quality of race/ethnicity data in a large, diverse, integrated health system that repeatedly collects these data on utilization of services. We tested the accuracy of Bayesian Improved Surname Geocoding for imputation of race/ethnicity data. Administrative race/ethnicity data were accurate as judged by comparison with self-report in adults. The Bayesian Improved Surname Geocoding method produced imputation results far better than chance assignment for the four most common race/ethnicity groups in the health system: Whites, Hispanics, Blacks, and Asians. These results support renewed efforts to conduct studies of racial and ethnic disparities in large health systems.

Asthma costs and utilization in a managed care organization

BACKGROUND Medical costs and health care utilization associated with asthma and the variation by treatment are poorly understood. OBJECTIVE To compare single controller inhaled corticosteroid (ICS) to other asthma drug regimens on medical costs and utilization. METHODS Direct medical costs and utilization were captured from administrative electronic databases from continuously enrolled members with asthma age 5 years or older with drug coverage. Asthma patients were identified during 2002, categorized into 14 asthma drug groups on the basis of 2003 prescription records, and had total medical costs and utilization determined in 2004 adjusting for demographics, insurance types, asthma risk, comorbidity, and propensity scores. RESULTS A total of 96,631 patients met the study eligibility criteria. Patients were (mean +/- SD) age 38 +/- 23 years and were 57% female, 14% Medicare, 4% Medicaid, and had a median family income (mean +/- SD) of

Effects of Glycemic Control on Prevalence of Diabetic Frozen Shoulder

64,967 +/-