Improving medical record retrieval for validation studies in Medicare data.

PURPOSE: The purpose of the study is to describe medical record retrieval for a study validating claims-based algorithms used to identify seven adverse events of special interest (AESI) in a Medicare population. METHODS: We analyzed 2010-2011 Medicare claims of women with postmenopausal osteoporosis and men ≥65 years of age in the Medicare 5% national sample. The final cohorts included beneficiaries covered continuously for 12+ months by Medicare parts A, B, and D and not enrolled in Medicare Advantage before starting follow-up. We identified beneficiaries using each AESI algorithm and randomly selected 400 women and 100 men with each AESI for medical record retrieval. The Centers for Medicare and Medicaid Services provided beneficiary contact information, and we requested medical records directly from providers, without patient contact. RESULTS: We selected 3331 beneficiaries (women: 2272; men: 559) for whom we requested 3625 medical records. Overall, we received 1738 [47.9% (95%CI 46.3%, 49.6%)] of the requested medical records. We observed small differences in the characteristics of the total population with AESIs compared with those randomly selected for retrieval; however, no differences were seen between those selected and those retrieved. We retrieved 54.7% of records requested from hospitals compared with 26.3% of records requested from physician offices (p < 0.001). Retrieval did not differ by sex or vital status of the beneficiaries. CONCLUSIONS: Our national medical record validation study of claims-based algorithms produced a modest retrieval rate. The medical record procedures outlined in this paper could have led to the improved retrieval from our previous medical record retrieval study. Copyright © 2016 John Wiley & Sons, Ltd.

Association of hyperlipidaemia, inflammation and serological status and coronary heart disease among patients with rheumatoid arthritis: data from the National Veterans Health Administration.

OBJECTIVE: To examine the association of serum lipids, inflammation and seropositivity on coronary heart disease (CHD) and stroke in patients with rheumatoid arthritis (RA). METHODS: The incidence of hospitalised myocardial infarction (MI) or stroke was calculated in a cohort of patients with RA receiving care within the national Veterans Health Administration from 1998 to 2011. Cox proportional hazard models were used to examine the association between these outcomes and low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), C reactive protein (CRP) and erythrocyte sedimentation rate (ESR) as time-varying variables, divided into quintiles. RESULTS: There were 37,568 patients with RA in the cohort with mean age of 63 years (SD 12.1); 90% were men. There was a no clear association between LDL-C and CHD/stroke. Compared with lower HDL-C (<34 mg/dL), higher HDL-C (≥54 mg/dL) was inversely associated with MI (hazard ratio (HR)=0.68, 95% CI 0.55 to 0.85) and stroke (HR=0.69, 95% CI 0.50 to 0.96). Higher CRP >2.17 mg/dL (vs CRP <0.26 mg/dL) was associated with increased risk (HR=2.43, 95% CI 1.77 to 3.33) for MI and 2.02 (95% CI 1.32 to 3.08) for stroke. ESR >47 mm/h compared with <8 mm/h had an HR 1.87 (95% CI 1.39 to 2.52) for MI and 2.00 (95% CI 1.26 to 3.18) for stroke. The association between MI was significant for RA seropositivity (HR=1.23, 95% CI 1.03 to 1.48). CONCLUSIONS: In this predominantly older male RA cohort, there was no clear association between LDL-C and CHD, whereas higher HDL-C was inversely associated with MI and stroke. CRP and ESR were similarly associated with increase MI risk and stroke, reflecting the prominent role of inflammation in CHD risk in RA.

The Design and Validation of a New Algorithm to Identify Incident Fractures in Administrative Claims Data.

Our study validated a claims-based algorithm for the identification of incident and recurrent fractures in administrative data. We used Centers for Medicare and Medicaid (CMS) claims from 2005 to 2014 linked to the Reasons for Geographic and Racial Differences in Stroke (REGARDS) database. Case qualifying (CQ) fractures were identified among participants with ≥12 months of fee-for-service coverage before first fracture claim and ≥6 months after. Recurrent fractures were defined as the first CQ fracture that occurred following a clean period of at least 90 days from the last claim associated with the preceding incident fracture. We used medical records (discharge summary, imaging, and surgical report) to adjudicate fractures. We calculated positive predictive values (PPVs) for incident and recurrent fractures. Our study was not designed to assess the algorithm sensitivity or negative predictive value. We identified 2049 potential incident fractures from claims among 1650 participants. Record retrieval was attempted for 728 (35.5%) suspected incident fractures (prioritizing more recent CQ fractures associated with osteoporosis, but without explicitly requiring any osteoporosis ICD-9 diagnosis code). Our final sample included 520 claims-identified fractures with medical records, of which 502 (96.5%) were confirmed. The PPVs (95% CI) of the hip, wrist, humerus, and clinical vertebra-all exceeded 95%. We identified 117 beneficiaries with 292 ≥2 CQ fracture episodes at the same site, and attempted retrieval on 105 (36.0%) episodes. Our analytic sample included 72 (68.5%) CQ episodes from 33 participants. The PPVs for identifying recurrent clinical vertebral, hip/femur, and nonvertebral fractures with a 90-day clean period exceeded 95%. Although we could not ascertain sensitivity, our updated fracture identification algorithms had high PPV for the identification of incident and recurrent fractures of the same site. Although medical record review and clinical adjudication remain a gold standard, our claims-based algorithm provides an alternative approach to fracture ascertainment when high PPV is desired. © 2019 American Society for Bone and Mineral Research.

The Validity of Claims-Based Algorithms to Identify Serious Hypersensitivity Reactions and Osteonecrosis of the Jaw.

Validation of claims-based algorithms to identify serious hypersensitivity reactions and osteonecrosis of the jaw has not been performed in large osteoporosis populations. The objective of this project is to estimate the positive predictive value of the claims-based algorithms in older women with osteoporosis enrolled in Medicare. Using the 2006-2008 Medicare 5% sample data, we identified potential hypersensitivity and osteonecrosis of the jaw cases based on ICD-9 diagnosis codes. Potential hypersensitivity cases had a 995.0, 995.2, or 995.3 diagnosis code on emergency department or inpatient claims. Potential osteonecrosis of the jaw cases had ≥1 inpatient or outpatient physician claim with a 522.7, 526.4, 526.5, or 733.45 diagnosis code or ≥2 claims of any type with a 526.9 diagnosis code. All retrieved records were redacted and reviewed by experts to determine case status: confirmed, not confirmed, or insufficient information. We calculated the positive predictive value as the number of confirmed cases divided by the total number of retrieved records with sufficient information. We requested 412 potential hypersensitivity and 304 potential osteonecrosis of the jaw records and received 174 (42%) and 84 (28%) records respectively. Of 84 potential osteonecrosis of the jaw cases, 6 were confirmed, resulting in a positive predictive value (95% CI) of 7.1% (2.7, 14.9). Of 174 retrieved potential hypersensitivity records, 95 were confirmed. After exclusion of 25 records with insufficient information for case determination, the overall positive predictive value (95% CI) for hypersensitivity reactions was 76.0% (67.5, 83.2). In a random sample of Medicare data, a claim-based algorithm to identify serious hypersensitivity reactions performed well. An algorithm for osteonecrosis of the jaw did not, partly due to the inclusion of diagnosis codes that are not specific for osteoporosis of the jaw.

The recent prevalence of osteoporosis and low bone mass in the United States based on bone mineral density at the femoral neck or lumbar spine.

The goal of our study was to estimate the prevalence of osteoporosis and low bone mass based on bone mineral density (BMD) at the femoral neck and the lumbar spine in adults 50 years and older in the United States (US). We applied prevalence estimates of osteoporosis or low bone mass at the femoral neck or lumbar spine (adjusted by age, sex, and race/ethnicity to the 2010 Census) for the noninstitutionalized population aged 50 years and older from the National Health and Nutrition Examination Survey 2005-2010 to 2010 US Census population counts to determine the total number of older US residents with osteoporosis and low bone mass. There were more than 99 million adults aged 50 years and older in the US in 2010. Based on an overall 10.3% prevalence of osteoporosis, we estimated that in 2010, 10.2 million older adults had osteoporosis. The overall low bone mass prevalence was 43.9%, from which we estimated that 43.4 million older adults had low bone mass. We estimated that 7.7 million non-Hispanic white, 0.5 million non-Hispanic black, and 0.6 million Mexican American adults had osteoporosis, and another 33.8, 2.9, and 2.0 million had low bone mass, respectively. When combined, osteoporosis and low bone mass at the femoral neck or lumbar spine affected an estimated 53.6 million older US adults in 2010. Although most of the individuals with osteoporosis or low bone mass were non-Hispanic white women, a substantial number of men and women from other racial/ethnic groups also had osteoporotic BMD or low bone mass.

Recent trends in hip fracture rates by race/ethnicity among older US adults.

Hip fracture incidence has declined among whites in the United States since 1995, but data on recent trends in racial and ethnic minorities are limited. The goal of this analysis was to investigate hip fracture incidence trends in racial/ethnic subgroups of older Medicare beneficiaries. We conducted a cohort study to determine annual hip fracture incidence rates from 2000 through 2009 using the Medicare national random 5% sample. Beneficiaries were eligible if they were ≥65 years of age and had 90 days of consecutive full fee-for-service Medicare coverage with no hip fracture claims. Race/ethnicity was self-reported. The incidence of hip fracture was identified using hospital diagnosis codes or outpatient diagnosis codes paired with fracture repair procedure codes. We computed age-standardized race/ethnicity-specific incidence rates and assessed trends in the rates over time using linear regression. On average, 821,475 women and 632,162 men were included in the analysis each year. Beneficiaries were predominantly white (88%), with African, Hispanic, and Asian Americans making up 8%, 1.5%, and 1.5% of the population, respectively. We identified 102,849, 4,119, 813, and 1,294 hip fractures in white, black, Asian, and Hispanic beneficiaries over the 10 years. A significant decreasing trend (p < 0.05) in hip fracture incidence from 2000-2001 to 2008-2009 was present in white women and men. Black and Asian beneficiaries experienced nonsignificant declines. Irrespective of gender, the largest rate of decline was seen in beneficiaries ≥75 years of age. The overall and age-specific rates of Hispanic women or men changed minimally over time. Hip fracture incidence rates continued to decline in recent years among white Medicare beneficiaries. Further research is needed to understand mechanisms responsible for declining rates in some and not others, as hip fractures continue to be a major problem among the elderly.

Toxicology review and risk assessment of resorcinol: thyroid effects.

Resorcinol administered at high doses to rodents can disrupt thyroid hormone synthesis and can produce goitrogenic effects. These effects were not seen in a 2-year bioassay at doses of up to 520 mg/kg/day. There are species-specific differences in synthesis, binding, and transport of thyroid hormone that complicate interpretation of goitrogenesis in rodents. Clinical case reports from patients undergoing resorcinol therapy for dermatological indications reveal thyroid side effects when copious amounts of resorcinol-containing ointments are applied to integrity-compromised skin for months to years. Effect levels were greater than 34 mg/kg/day. Occupational epidemiology studies provide no evidence that exposure to resorcinol at levels greater than found in the general environment causes thyroid dysfunction. Studies investigating the relationship between endemic goiter and exposure to "phenolics," including resorcinol, in drinking water do not fulfill accepted scientific criteria for establishing resorcinol as a cause of thyroid disease. Those reports neither quantify exposure levels nor demonstrate dose-response relationships or rule out confounding by the multiple other chemicals present in water supplies, by bacterial contamination of water, or by nutritional factors. A risk assessment comparing potential worst-case exposures to resorcinol through its use in dermatological preparations supports the conclusion that under real-world conditions, human exposures to resorcinol are not expected to cause adverse effects on thyroid function.