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Quality control and harmonization of data is a vital and challenging undertaking for any successful data coordination center and a responsibility shared between the multiple sites that produce, integrate, and utilize the data. Here we describe a coordinated effort between scientists and data managers in the Cancer Family Registries to implement a data governance infrastructure consisting of both organizational and technical solutions. The technical solution uses a rule-based validation system that facilitates error detection and correction for data centers submitting data to a central informatics database. Validation rules comprise both standard checks on allowable values and a crosscheck of related database elements for logical and scientific consistency. Evaluation over a 2-year timeframe showed a significant decrease in the number of errors in the database and a concurrent increase in data consistency and accuracy. [ABSTRACT FROM AUTHOR]

Health disparities are differences in health status across different socioeconomic groups. Classical methods, e.g., the Delta method, have been used to estimate the standard errors of estimated measures of health disparities and to construct confidence intervals for these measures. However, the confidence intervals constructed using the classical methods do not have good coverage properties for situations involving sparse data. In this article, we introduce three new methods to construct fiducial intervals for measures of health disparities based on approximate fiducial quantities. Through a comprehensive simulation study, We compare the empirical coverage properties of the proposed fiducial intervals against two Monte Carlo simulation-based methods-utilizing either a truncated Normal distribution or the Gamma distribution-as well as the classical method. The findings of the simulation study advocate for the adoption of the Monte Carlo simulation-based method with the Gamma distribution when a unified approach is sought for all health disparity measures.

We describe a new method for presenting and interpreting linear trends in health inequalities, and present a proof-of-concept analysis of inequalities in smoking among adolescents in Europe. We estimated the regression line of the assumed linear relationship between smoking prevalence in low- and high-socioeconomic status (SES) youth over time. Using simulation, we constructed a 95% confidence interval (CI) for the smoking prevalence in low-SES youth for when this would be 0% in high-SES youth, and we calculated the likelihood of eradicating smoking inequality (<5% for both low and high SES). This method was applied to data on adolescents aged 15-16 years (n = 250,326) from 23 European countries, derived from the 2003-2015 European Survey Project on Alcohol and Other Drugs. Smoking prevalence decreased more slowly among low- than among high-SES adolescents. The estimated smoking prevalence was 9.4% (95% CI: 6.1, 12.7) for boys and 5.4% (95% CI: 1.4, 9.2) for girls with low SES when 0% with high SES. The likelihood of eradicating smoking inequality was <1% for boys and 37% for girls. We conclude that this novel methodological approach to trends in health inequalities is feasible in practice. Applying it to trends in smoking inequalities among adolescents in Europe, we found that Europe is currently not on track to eradicate youth smoking across SES groups., (© The Author(s) 2023. Published by Oxford University Press on behalf of the Johns Hopkins Bloomberg School of Public Health. This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (https://creativecommons.org/licenses/by-nc/4.0), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journalpermissions@oup.com.)

Directed acyclic graphs (DAGs) are increasingly used in epidemiology to identify and address different types of bias. The present work aims to demonstrate how DAG-based data simulation can be used to understand bias and compare data analytical strategies in an educational context. Examples based on classical confounding situations and an M-DAG are examined and used to introduce basic concepts and demonstrate some important features of regression analysis, as well as the harmful effect of adjusting for a collider variable. Other potential uses of DAG-based data simulation include systematic comparisons of data analytical strategies or the evaluation of the role of uncertainties in a hypothesized DAG structure, including other types of bias such as information bias. DAG-based data simulations, like those presented here, should facilitate the exploration of several key epidemiological concepts, DAG theory and data analysis. Some suggestions are also made on how to further expand the ideas from this study., (© The Author(s) 2021; all rights reserved. Published by Oxford University Press on behalf of the International Epidemiological Association.)

Introduction: The WHO established the MPOWER policy package to boost the implementation of the WHO Framework Convention for Tobacco Control (WHO FCTC) in 2008 and to provide practical guidance on policies effective at reducing smoking rates. An easily applied Abridged SimSmoke was developed to help countries gauge the effect of these policies using data from the WHO MPOWER/WHO Report (MPOWER Report) and is applied to four Eastern Mediterranean countries., Methods: The number of smokers in a country is calculated using the country's smoking prevalence and population. Policy effect sizes, based on previously validated SimSmoke models, are applied to the smoker populations to determine the reduction in the number of smokers resulting from implementing policies. The number of smoking-attributable deaths is derived based on findings that half of those smokers alive today will die from smoking., Results: Within 40 years, implementing the complete set of MPOWER policies is projected to reduce smoking prevalence by 29% (range 15%, 41%) and avert almost 1 (range 0.5, 1.4) million deaths in Egypt, reduce smoking prevalence by 52% (range 36%, 66%) and avert 156 000 (106 000, 196 000) deaths in Lebanon, reduce smoking prevalence by 56% (range 40%, 69%) and avert 3.5 (range 2.5, 4.3) million deaths in Pakistan, and reduce smoking prevalence by 37% (range 21%, 51%) and avert 245 000 (range 138 000, 334 000) deaths in Tunisia., Conclusions: The Abridged SimSmoke model has been used to show the number of deaths from smoking and how MPOWER policies can be used to reach the WHO non-communicable deaths voluntary target for cigarette use reduction in four countries., (Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/)

Background: In patients with chronic hepatitis C (CHC), obesity is involved in the pathogenesis of insulin resistance, fatty liver disease and progression of fibrosis. The objective of this study was to compare a normoglucidic low-calorie diet (NGLCD) with a low-fat diet (LFD) among participants with CHC. Aimed to measure the impact of dietary changes in reduction of insulin resistance, obesity but also in steatosis and fibrosis., Methods: Randomized, controlled trial in three medical centers with assessments at baseline, 6 months and 12 months. Participants were patients over 35 years with chronic hepatitis C (n = 120) with BMI over 25 kg/m². We evaluated the effects of NGLCD vs. LFD in weight management and metabolic improvement. The primary endpoint was to measure the impact of dietary changes through nutritional intervention in reversibility of insulin resistance, obesity, steatosis, and fibrosis. We performed anthropometric measurements, fasting glucose profile, serum lipids, liver profile, blood count at baseline, 6 and 12 months. Steatosis was evaluated using ultrasonographic criteria. Liver fibrosis was non-invasively assessed., Results: After 6 and 12 months of intervention, both groups had a significant decrease in caloric consumption. At 6 months, weight loss was greater in the NGLCD group (-5.02 ± 3.43 kg vs. -4.1 ± 2.6 kg; p = 0.002) compared to the LFD group. At 1-year, however, weight loss was similar in both groups (-3.9 ± 3.3 kg vs. -3.1 ± 2.6 kg; p = 0.139). At 12 months, fasting plasma glucose, fasting plasma insulin, and HOMA-IR had significant improvements in both groups. With both diets aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyl transpeptidase (GGT) decreased with significant differences; also there were significant improvements in AST/ALT ratio, Forns fibrosis index. The two diets were associated with reduction of both the prevalence and the severity of steatosis (all p < 0.001). At 12 months, total cholesterol, HDL-cholesterol, triglycerides improved in both groups (all p < 0.05)., Conclusions: The present study establishes the benefits of low-calorie diet and low-fat diet in management of patients with hepatitis C regarding improvement of insulin resistance, steatosis and also fibrosis.Overweight or obese patients with CHC undergoing a lifestyle intervention (specific dietary intervention and physical activity) for 1-year had significant improvements in body weight, lipid and hepatic profile., Trial Registration: PNCI2-3343/41008/2007.

Objective: To compare potential risk factors for uterine leiomyomata (UL) subtypes among premenopausal African American and Caucasian women., Methods: This cross-sectional study included 986 premenopausal women, aged 35 to 49 years old, from the National Institute of Environmental Health Sciences (NIEHS) Uterine Fibroid Study (UFS). Uterine leiomyomata were subtyped as submucosal, intramural/subserosal, and diffuse, based on ultrasound examinations., Results: For both ethnic groups, age, age at menarche, body mass index, and current physical activity had similar associations across the 3 UL subtypes. Inverse associations with pregnancies after age 24 appeared to be stronger for the submucosal subtype. Current smoking was associated only with diffuse UL (adjusted odds ratio [aOR] = 1.97, 95% CI: 1.11, 3.51 in African Americans, aOR = 3.00, 95% CI: 1.07, 8.38 in Caucasians)., Conclusions: Although the 2 focal UL subtypes had similar risk factor profiles, the diffuse UL subtype appeared to have a distinctive risk profile with regard to current smoking. Further study of the diffuse heterogeneity seen with uterine ultrasound is needed.

Objective: To estimate the lifetime risk of symptomatic hip osteoarthritis (OA)., Design: We analyzed data from the Johnston County Osteoarthritis Project [a longitudinal population-based study of OA in North Carolina, United States (n=3068)]. The weighted baseline sample comprised 18% blacks and 54% women, and the mean age was 63 years (range=45-93). Symptomatic hip OA was defined as a Kellgren-Lawrence (K-L) radiographic score of ≥ 2 (anterior-posterior pelvis X-rays) and pain, aching or stiffness on most days, or groin pain, in the same hip. Lifetime risk, defined as the proportion who developed symptomatic hip OA in at least one hip by age 85, among people who live to age 85, was modeled using logistic regression with repeated measures (through generalized estimating equations)., Results: Lifetime risk of symptomatic hip OA was 25.3% [95% confidence interval (CI)=21.3-29.3]. Lifetime risk was similar by sex, race, highest educational attainment, and hip injury history. We studied lifetime risk by body mass index (BMI) in three forms: at age 18; at baseline and follow-up; and at age 18, baseline and follow-up and found no differences in estimates., Conclusion: The burden of symptomatic hip OA is substantial with one in four people developing this condition by age 85. The similar race-specific estimates suggest that racial disparities in total hip replacements are not attributable to differences in disease occurrence. Despite increasing evidence that obesity predicts an increased risk of both hip OA and joint replacement, we found no association between BMI and lifetime risk., (Copyright © 2010 Osteoarthritis Research Society International. Published by Elsevier Ltd. All rights reserved.)

Aims: To investigate the association between the presence and characteristics of uterine leiomyomata (UL) and self-reported stress urinary incontinence (SUI)., Methods: The study included 836 premenopausal participants (474 African American and 362 Caucasian) in the National Institute of Environmental Health Sciences (NIEHS) Uterine Fibroid Study. UL were characterized at baseline with ultrasound screening, and SUI was assessed at follow-up (after 4 years, on average). Linear risk models were used to estimate adjusted prevalence differences (aPD) and 95% confidence intervals (CI), controlling for age, ethnicity, body mass index (BMI), and number of deliveries., Results: Compared with women without UL, SUI prevalence was higher among women with any UL (aPD = 7.4%, 95% CI 0.4-14.3) and women with UL 2-4 cm (aPD = 9.6%, 95% CI 1.3-17.9). Marginally significant results were found for the presence of UL > or =4 cm and anterior UL > or =2 cm., Conclusions: The observed 7% increase in prevalence of this common condition for women with UL is of clinical importance. Further research is needed before concluding that treatment for larger UL might enhance SUI treatment in some women.

Objective: To report contemporary estimates of the prevalence of hip-related osteoarthritis (OA) outcomes in African Americans and Caucasians aged>or=45 years., Methods: Weighted prevalence estimates and their corresponding 95% confidence intervals for hip symptoms, radiographic hip OA, symptomatic hip OA, and severe radiographic hip OA were calculated using SUDAAN for age, race, and sex subgroups among 3068 participants (33% African Americans, 38% men) in the baseline examination (1991-97) of The Johnston County Osteoarthritis Project, a population-based study of OA in North Carolina. Radiographic hip OA was defined as Kellgren-Lawrence radiographic grade>or=2, moderate/severe radiographic hip OA as grades 3 and 4, and symptomatic hip OA as hip symptoms in a hip with radiographic OA., Results: Hip symptoms were present in 36%; 28% had radiographic hip OA; nearly 10% had symptomatic hip OA; and 2.5% had moderate/severe radiographic hip OA. Prevalence of all 4 outcomes was higher in older individuals; most outcomes were higher for women and African Americans., Conclusion: African Americans in this population do not have a lower prevalence of hip-related OA outcomes as previous studies suggested. Increasing public and health system awareness of the relatively high prevalence of these outcomes, which can be disabling, may help to decrease their effects and ultimately prevent them.

Objective: High-sensitivity C-reactive protein (hsCRP) in serum is used as a marker of risk for cardiovascular disease (CVD); however CRP is a non-specific acute phase reactant. We evaluated the association between hsCRP concentrations and the most common form of arthritis, osteoarthritis (OA), and assessed the applicability of hsCRP for CVD risk prediction., Methods: Participants (n=662) were selected from the population-based Johnston County Osteoarthritis Project, using stratified simple random sampling to achieve balance according to radiographic knee OA status, ethnic group, gender, and age group. The presence and severity of knee and hip OA were determined radiographically. CVD risk was estimated by hsCRP concentration and independently with the Framingham risk algorithm., Results: Serum natural log-transformed hsCRP (ln hsCRP) was higher in African-Americans (P<0.0001) and women (P<0.0001), was higher in participants who had chronic pulmonary disease (P=0.01), hypertension (P<0.0001), or used pain medications (P=0.004), and correlated with body mass index (BMI) (r=0.40, P<0.0001) and waist circumference (r=0.33, P<0.0001), but not with age, CVD, or current smoking. Ln hsCRP was strongly positively associated with all definitions of radiographic OA (rOA; P<0.0001), but this association was not independent of BMI. Although 183 participants reported no CVD and were classified as low risk by the Framingham CVD score, 61% of them were classified as moderate or high risk for CVD using hsCRP; this proportion designated high risk for CVD on the basis of hsCRP consisted primarily of women (P<0.05) and individuals with OA (P<0.01)., Conclusions: The pathogenic significance of hsCRP elevations in this subgroup is unclear. Serum hsCRP for predicting risk of CVD is confounded by obesity, ethnicity, gender and comorbidities.

Objective: Osteoarthritis (OA) is one of the most common diseases among the elderly. The main characteristic is the progressive destruction of articular cartilage. We lack quantitative and sensitive biomarkers for OA to detect changes in the joints in an early stage of the disease. In this study, we investigated whether a urinary metabolite profile could be found that could serve as a diagnostic biomarker for OA in humans. We also compared the profile we obtained previously in the guinea pig spontaneous OA model., Methods: Urine samples of 92 participants (47 non-OA controls and 45 individuals with radiographic OA of the knees or hips) were selected from the Johnston County Osteoarthritis Project (North Carolina, USA). Participants ranged in age from 60 to 84 years. Samples were measured by 1H nuclear magnetic resonance spectroscopy (NMR) with subsequent principal component discriminant analysis and partial least squares regression analysis., Results: Differences were observed between urine NMR spectra of OA cases and controls (P<0.001 for both male and female subjects). A metabolite profile could be determined which was strongly associated with OA. This profile largely resembled the profile previously identified for guinea pigs with OA (approximately 40 out of the approximately 125 signals of the human profile were present in the guinea pig profile as well). A correlation was found between the metabolite profile and radiographic OA severity (R2 = 0.82 (male); R2 = 0.93 (female))., Conclusion: This study showed that a urine metabolite profile may serve as a novel discriminating biomarker of OA.

Objective: Serum hyaluronan (HA) has been proposed as a potential biomarker of osteoarthritis (OA). We examined associations between serum HA and radiographic OA in an ethnically diverse, population-based sample., Methods: Participants were selected from the Johnston County Osteoarthritis Project, using stratified simple random sampling to achieve balance according to radiographic knee OA status, ethnic group, sex, and age group. Serum HA was measured by enzyme-linked immunosorbent assay. Radiographic OA variables included knee OA, knee OA laterality, knee OA severity, concomitant knee and hip OA, and total number of OA-affected knee and hip joints. Analysis of covariance was used to assess differences in mean serum levels of natural log-transformed HA (ln serum HA) between groups, adjusting for ethnicity, sex, age, body mass index (BMI), and self-reported comorbidities., Results: Levels of ln serum HA were positively associated with all definitions of radiographic OA (P < 0.0001). Levels of ln serum HA were higher in Caucasians (P = 0.0094) and in men (P = 0.0038) and were moderately correlated with age (r = 0.35, P < 0.0001). The associations with radiographic OA, ethnicity, sex, and age remained statistically significant after adjustment (P < 0.0045). There were no interactions between ethnicity and the other covariates., Conclusion: These cross-sectional data support a role for serum HA as a biomarker of radiographic OA. The variations in levels of serum HA attributable to ethnicity, sex, and age were not explained by radiographic OA, BMI, or comorbidities. The lack of strong confounding between serum HA and comorbidities further supports a role for serum HA as a potential biomarker.

Objective: Previous descriptions of potential biomarkers of osteoarthritis (OA) have been limited to Caucasians. In the present study, we examined associations between serum levels of cartilage oligomeric matrix protein (COMP) and ethnicity (African American or Caucasian) and sex in the Johnston County Osteoarthritis Project, a population-based study of OA in rural North Carolina., Methods: All African Americans and a randomly selected sample of Caucasians who had available sera and either no radiographic evidence of knee or hip OA according to the Kellgren/Lawrence (K/L) system (K/L grade 0) or radiographic evidence of knee OA (K/L grade 2 or higher) were included. Serum COMP levels were quantified by sandwich enzyme-linked immunosorbent assay, using monoclonal antibodies 16-F12 and 17-C10. Linear regression models were used to assess relationships between serum levels of natural log-transformed COMP (ln COMP) and ethnicity and sex, controlling for age, height, body mass index (BMI), radiographic OA, and the presence of other symptomatic joints. Radiographic OA was defined in separate models as the presence, severity, and laterality of radiographic knee OA, the co-occurrence of radiographic knee and hip OA, and the number of knees and hips with radiographic OA., Results: The 769 subjects in the study sample had a mean +/- SD age of 62 +/- 10.3 years. Levels of ln COMP were associated with age, BMI, and all definitions of radiographic OA (P = 0.0001), and varied by ethnicity and sex. In adjusted models, ln COMP was higher in African American women than in Caucasian women (P = 0.003) and higher in Caucasian men than Caucasian women (P = 0.0001). There were no statistically significant differences in serum ln COMP levels between African American men and women., Conclusion: Serum COMP levels vary by ethnicity and sex. These factors should be considered in the derivation of standards using this, and possibly other, potential biomarkers of OA.

Objective: To examine the cross-sectional relationship between serum cartilage oligomeric matrix protein (COMP) and hip and knee clinical signs and symptoms in a sample of adults without radiographic hip or knee osteoarthritis (OA)., Design: A total of 145 persons with available sera and no evidence of radiographic hip or knee OA (Kellgren-Lawrence grade 0) were randomly selected from the Caucasian participants of the Johnston County Osteoarthritis Project. COMP was quantified by a competitive ELISA assay with a monoclonal antibody 17-C10. Hip and knee clinical signs and symptoms were assessed by physical examination and interview, and their associations with Ln COMP analysed with general linear models., Results: After adjustment for age, gender, body mass index (BMI), and other symptomatic joints, mean Ln COMP was statistically significantly higher among persons with hip-related clinical signs (P=0.018), among those with hip-related symptoms (P=0.046), and among individuals meeting American College of Rheumatology clinical criteria for hip OA (P=0.021). There were no statistically significant associations between any of the knee-related clinical signs and symptoms and Ln COMP., Conclusion: Serum COMP may be useful as a biomarker of pre-radiographic hip joint pathology; its utility as a biomarker of pre-radiographic knee joint pathology is unclear., (Copyright 2002 OsteoArthritis Research Society International. Published by Elsevier Science Ltd. All rights reserved.)

Objective: To characterize serum cartilage oligomeric matrix protein (COMP) levels by age and gender for a radiographically defined population free of hip and knee osteoarthritis (OA), and to examine the potential utility of COMP as a diagnostic biomarker for knee OA., Methods: Serum samples and knee and hip radiographs were obtained at a baseline evaluation as part of the Johnston County Osteoarthritis Project, a population-based study of OA in rural North Carolina. A total of 291 Caucasian participants were randomly selected for COMP analysis, 143 patients with radiographic knee OA (Kellgren/Lawrence [K/L] grade > or = 2) and 148 controls with neither hip nor knee OA (K/L grade 0), evenly distributed by age and gender. COMP was quantified by competitive enzyme-linked immunosorbent assay with monoclonal antibody 17-C10. The natural log-transformed COMP data were analyzed using general linear models., Results: Serum COMP levels were significantly elevated (P = 0.0001) in the age > or = 65 group (mean +/- SD 1,302.1 +/- 496.7 ng/ml) versus the age 45-54 and age 55-64 groups (1,058.1 +/- 432.4 and 1,038.6 +/- 313.3, respectively). Serum COMP levels of the OA group were significantly higher than those of the control group (1,208.57 +/- 487.47 ng/ml versus 1,061.83 +/- 370.58 ng/ml; P = 0.0093). Serum COMP levels also increased significantly with knee OA K/L grade (P = 0.0047), knee OA laterality (P = 0.0043), and number of knee and hip joints involved (P = 0.0001). There was no significant difference in serum COMP levels by gender or obesity., Conclusion: We demonstrate that in a population-based sample, serum COMP levels can distinguish an OA-affected subgroup from an unaffected subgroup and can reflect disease severity and multiple joint involvement in OA.