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Article ; Online: A repeated measures approach to pooled and calibrated biomarker data

Sloan, Abigail / Cheng, Chao / Rosner, Bernard / Ziegler, Regina G. / Smith‐Warner, Stephanie A. / Wang, Molin

Biometrics. 2023 June, v. 79, no. 2 p.1485-1495

2023

Abstract: Participant‐level meta‐analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of ... ...

Abstract	Participant‐level meta‐analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of interest, investigators must first calibrate the data to address measurement variability arising from usage of different laboratories and/or assays. In practice, the calibration process involves reassaying a random subset of biospecimens from each study at a central laboratory and fitting models that relate the study‐specific “local” and central laboratory measurements. Previous work in this area treats the calibration process from the perspective of measurement error techniques and imputes the estimated central laboratory value among individuals with only a local laboratory measurement. In this work, we propose a repeated measures method to calibrate biomarker measurements pooled from multiple studies with study‐specific calibration subsets. We account for correlation between measurements made on the same person and between measurements made at the same laboratory. We demonstrate that the repeated measures approach provides valid inference, and compare it to existing calibration approaches grounded in measurement error techniques in an example describing the association between circulating vitamin D and stroke.
Keywords	biomarkers ; calibration ; meta-analysis ; sample size ; stroke
Language	English
Dates of publication	2023-06
Size	p. 1485-1495.
Publishing place	John Wiley & Sons, Ltd
Document type	Article ; Online
Note	JOURNAL ARTICLE
ZDB-ID	213543-7
ISSN	0099-4987 ; 0006-341X
ISSN	0099-4987 ; 0006-341X
DOI	10.1111/biom.13618
Database	NAL-Catalogue (AGRICOLA)

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Article ; Online: A repeated measures approach to pooled and calibrated biomarker data.

Sloan, Abigail / Cheng, Chao / Rosner, Bernard / Ziegler, Regina G / Smith-Warner, Stephanie A / Wang, Molin

Biometrics

2022 Volume 79, Issue 2, Page(s) 1485–1495

Abstract: Participant-level meta-analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of ... ...

Abstract	Participant-level meta-analysis across multiple studies increases the sample size for pooled analyses, thereby improving precision in effect estimates and enabling subgroup analyses. For analyses involving biomarker measurements as an exposure of interest, investigators must first calibrate the data to address measurement variability arising from usage of different laboratories and/or assays. In practice, the calibration process involves reassaying a random subset of biospecimens from each study at a central laboratory and fitting models that relate the study-specific "local" and central laboratory measurements. Previous work in this area treats the calibration process from the perspective of measurement error techniques and imputes the estimated central laboratory value among individuals with only a local laboratory measurement. In this work, we propose a repeated measures method to calibrate biomarker measurements pooled from multiple studies with study-specific calibration subsets. We account for correlation between measurements made on the same person and between measurements made at the same laboratory. We demonstrate that the repeated measures approach provides valid inference, and compare it to existing calibration approaches grounded in measurement error techniques in an example describing the association between circulating vitamin D and stroke.
MeSH term(s)	Humans ; Vitamin D ; Research Design ; Biomarkers/analysis ; Sample Size ; Calibration
Chemical Substances	Vitamin D (1406-16-2) ; Biomarkers
Language	English
Publishing date	2022-03-13
Publishing country	United States
Document type	Meta-Analysis ; Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	213543-7
ISSN	1541-0420 ; 0099-4987 ; 0006-341X
ISSN (online)	1541-0420
ISSN	0099-4987 ; 0006-341X
DOI	10.1111/biom.13618
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Article ; Online: Association between use of vitamin and mineral supplement and non-alcoholic fatty liver disease in hypertensive adults.

Park, Yoonmi / Smith-Warner, Stephanie A / Zhang, Xuehong / Park, Yoon Jung / Kim, Hyesook / Park, Hyesook / Lee, Hye Ah / Jung, Seungyoun

Scientific reports

2023 Volume 13, Issue 1, Page(s) 13670

Abstract: Non-alcoholic fatty liver disease (NAFLD) is the most common hepatic metabolic disorder in hypertensive adults. Impaired metabolism of micronutrients may increase NAFLD risk by exacerbating oxidative stress, insulin resistance, and inflammation among ... ...

Abstract	Non-alcoholic fatty liver disease (NAFLD) is the most common hepatic metabolic disorder in hypertensive adults. Impaired metabolism of micronutrients may increase NAFLD risk by exacerbating oxidative stress, insulin resistance, and inflammation among hypertensive adults. In this first cross-sectional analysis of 7,376 hypertensive adults with 2,015 NAFLD cases in the Korea National Health and Nutrition Examination Survey, vitamin and mineral supplements (VMS) use was identified via questionnaire. NAFLD was defined by a hepatic steatosis index > 36. Multivariable-adjusted odds ratios (MVOR) and 95% confidence intervals (CIs) were calculated using logistic regression models. In our study, 18.6% were current users of VMS; of these, 76.7% used multi-vitamin/mineral supplements. Current VMS users had significantly lower odds of NAFLD, compared with non-users (MVOR [95% CI]: 0.73 [0.58-0.92]). The inverse association became attenuated and non-significant among those consuming VMS at higher frequency (≥ 2 times/day), for longer duration (> 16 months), and taking ≥ 2 VMS products. The inverse association with current use of VMS was only evident in those aged < 56 years (MVOR [95% CI]: 0.54 [0.40-0.72]) and men (MVOR [95% CI]: 0.56 [0.40-0.80])(P
MeSH term(s)	Adult ; Humans ; Male ; Non-alcoholic Fatty Liver Disease/epidemiology ; Cross-Sectional Studies ; Nutrition Surveys ; Minerals ; Vitamins
Chemical Substances	Minerals ; Vitamins
Language	English
Publishing date	2023-08-22
Publishing country	England
Document type	Journal Article ; Research Support, Non-U.S. Gov't
ZDB-ID	2615211-3
ISSN	2045-2322 ; 2045-2322
ISSN (online)	2045-2322
ISSN	2045-2322
DOI	10.1038/s41598-023-40868-1
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Article ; Online: Lifetime dairy product consumption and breast cancer risk: a prospective cohort study by tumor subtypes.

Riseberg, Emily / Wu, You / Lam, Wai Ching / Eliassen, A Heather / Wang, Molin / Zhang, Xuehong / Willett, Walter C / Smith-Warner, Stephanie A

The American journal of clinical nutrition

2023 Volume 119, Issue 2, Page(s) 302–313

Abstract: Background: Previous literature on dairy products and risk of breast cancer is inconsistent, and the relationship may depend on the life-period of dietary assessment.: Objective: We examined dairy consumption from adolescence through later adulthood ... ...

Abstract	Background: Previous literature on dairy products and risk of breast cancer is inconsistent, and the relationship may depend on the life-period of dietary assessment. Objective: We examined dairy consumption from adolescence through later adulthood and incidence of breast cancer by menopausal status and tumor molecular subtypes in the Nurses' Health Study (NHS), a prospective cohort study. Methods: We analyzed data from 63,847 females in the NHS collected from 1980 to 2018. Average intake of dairy products during adulthood was assessed by validated semiquantitative food frequency questionnaires throughout follow-up. Participants recalled adolescent dietary intake in 1986. Multivariable Cox proportional hazards models were used to estimate hazard ratios (HRs) relating dairy product consumption to breast cancer risk overall, by menopausal status, and by subtypes. Results: We documented 5733 incident cases of invasive breast cancer during 32 y of follow-up (n = 5298 postmenopausal). Lifetime, adolescent, adulthood, and postmenopausal total dairy and milk intakes were not associated with overall breast cancer risk (nonsignificant HRs comparing highest with lowest quintile range = 0.97-1.08), although there was a suggestive positive association between adolescent milk intake and breast cancer risk (HR: 1.09; 95% CI: 1.00, 1.18). Higher lifetime and premenopausal cheese intakes were associated with modestly lower risks of breast cancer (comparing highest with lowest quintile, HR for lifetime cheese intake: 0.90; 95% CI: 0.82, 0.98; HR for premenopausal cheese intake: 0.89; 95% CI: 0.79, 1.00). Results varied by tumor subtype and some evidence for heterogeneity was observed for an association between premenopausal milk intake and breast cancer (HR for estrogen receptor [ER]-positive: 0.84; 95% CI: 0.72, 0.99; ER-negative: 1.36; 95% CI: 1.00, 1.84; P heterogeneity = 0.04). Conclusions: These findings suggest that overall dairy consumption was not associated with risk of breast cancer. However, heterogeneity was observed for type of dairy food, period of life, and tumor subtypes.
MeSH term(s)	Female ; Adolescent ; Humans ; Adult ; Breast Neoplasms/epidemiology ; Breast Neoplasms/etiology ; Prospective Studies ; Dairy Products ; Risk ; Incidence ; Risk Factors ; Diet
Language	English
Publishing date	2023-11-30
Publishing country	United States
Document type	Journal Article
ZDB-ID	280048-2
ISSN	1938-3207 ; 0002-9165
ISSN (online)	1938-3207
ISSN	0002-9165
DOI	10.1016/j.ajcnut.2023.11.017
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Article ; Online: Reply to Flegal.

Teras, Lauren R / Patel, Alpa V / Smith-Warner, Stephanie A

Journal of the National Cancer Institute

2020 Volume 112, Issue 7, Page(s) 770

MeSH term(s)	Body Mass Index ; Breast Neoplasms ; Female ; Humans ; Obesity ; Prospective Studies ; Weight Loss
Language	English
Publishing date	2020-02-26
Publishing country	United States
Document type	Letter ; Comment
ZDB-ID	2992-0
ISSN	1460-2105 ; 0027-8874 ; 0198-0157
ISSN (online)	1460-2105
ISSN	0027-8874 ; 0198-0157
DOI	10.1093/jnci/djaa027
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Article ; Online: Pesticide Residue Intake From Fruit and Vegetable Consumption and Risk of Glioma.

Cote, David J / Bever, Alaina M / Chiu, Yu-Han / Sandoval-Insausti, Helena / Smith-Warner, Stephanie A / Chavarro, Jorge E / Stampfer, Meir J

American journal of epidemiology

2022 Volume 191, Issue 5, Page(s) 825–833

Abstract: We aimed to determine whether intake of pesticide residues from fruits and vegetables was associated with glioma. Within 3 prospective cohorts from 1998-2016-the Nurses' Health Study (NHS), Nurses' Health Study II (NHSII), and Health Professionals Follow- ...

Abstract	We aimed to determine whether intake of pesticide residues from fruits and vegetables was associated with glioma. Within 3 prospective cohorts from 1998-2016-the Nurses' Health Study (NHS), Nurses' Health Study II (NHSII), and Health Professionals Follow-up Study-we computed multivariable-adjusted hazard ratios (MVHRs) and 95% confidence intervals (CI) for glioma by quintiles of intake of low- and high-pesticide-residue fruits and vegetables using Cox proportional hazards regression. Fruits and vegetables were categorized as high or low residue using a validated method based on pesticide surveillance data. We confirmed 275 glioma cases across 2,745,862 person-years. A significant association was observed between intake of high-residue fruits and vegetables and glioma in NHS (MVHR = 2.99, 95% CI: 1.38, 6.44 comparing highest with lowest quintile, P for trend = 0.02). This was not identified in NHSII (MVHR = 0.52, 95% CI: 0.19, 1.45, P for trend = 0.20) or Health Professionals Follow-up Study (MVHR = 1.01, 95% CI: 0.42, 2.45, P for trend = 0.39). No significant associations were observed by intake of low-residue fruits and vegetables; overall intake was not significantly associated with glioma in any cohort. We found no evidence for an inverse relationship of fruit and vegetable intake with glioma. Although limited in power, this study suggests a possible association between fruit-and-vegetable pesticide residue intake and risk of glioma that merits further study.
MeSH term(s)	Diet ; Follow-Up Studies ; Fruit/chemistry ; Glioma/epidemiology ; Glioma/etiology ; Humans ; Pesticide Residues ; Pesticides/adverse effects ; Prospective Studies ; Risk Factors ; Vegetables/chemistry
Chemical Substances	Pesticide Residues ; Pesticides
Language	English
Publishing date	2022-01-17
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2937-3
ISSN	1476-6256 ; 0002-9262
ISSN (online)	1476-6256
ISSN	0002-9262
DOI	10.1093/aje/kwac007
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Article ; Online: Total calcium, dairy foods and risk of colorectal cancer: a prospective cohort study of younger US women.

Kim, Hanseul / Hur, Jinhee / Wu, Kana / Song, Mingyang / Wang, Molin / Smith-Warner, Stephanie A / Zhang, Xuehong / Giovannucci, Edward L

International journal of epidemiology

2022 Volume 52, Issue 1, Page(s) 87–95

Abstract: Background: Although colorectal cancer (CRC) incidence is declining among adults aged ≥65 years, CRC incidence in younger adults has been rising. The protective role of calcium in colorectal carcinogenesis has been well established, but evidence is ... ...

Abstract	Background: Although colorectal cancer (CRC) incidence is declining among adults aged ≥65 years, CRC incidence in younger adults has been rising. The protective role of calcium in colorectal carcinogenesis has been well established, but evidence is lacking on whether the association varies by age at diagnosis. We investigated the association between total calcium intake and risk of overall CRC and CRC before age 55 years. Methods: In the Nurses' Health Study II (1991-2015), 94 205 women aged 25-42 years at baseline were included in the analysis. Diet was assessed every 4 years through validated food frequency questionnaires. Multivariable-adjusted hazard ratios (HRs) and 95% CIs for CRC were estimated using the Cox proportional hazards model. Results: We documented 349 incident CRC cases during 2 202 604 person-years of follow-up. Higher total calcium intake was associated with a reduced risk of CRC. Compared with those with <750 mg/day of total calcium intake, the HR of CRC was 0.61 (95% CI, 0.38-0.97) for those who consumed ≥1500 mg/day (P for trend = 0.01). The HR per 300 mg/day increase was 0.85 (95% CI, 0.76-0.95). There was a suggestive inverse association between total calcium intake and CRC before age 55 years (HR per 300 mg/day increase, 0.87; 95% CI, 0.75-1.00), suggesting the importance of calcium intake in the younger population. Conclusions: In a cohort of younger women, which reflects the birth cohorts, time periods and age ranges paralleling the recent rise in CRC, higher calcium intake was associated with a decreased risk of CRC.
MeSH term(s)	Adult ; Humans ; Female ; Calcium ; Prospective Studies ; Food ; Surveys and Questionnaires ; Colorectal Neoplasms/epidemiology ; Colorectal Neoplasms/diagnosis ; Risk Factors
Chemical Substances	Calcium (SY7Q814VUP)
Language	English
Publishing date	2022-10-31
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, Non-U.S. Gov't
ZDB-ID	187909-1
ISSN	1464-3685 ; 0300-5771
ISSN (online)	1464-3685
ISSN	0300-5771
DOI	10.1093/ije/dyac202
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Article ; Online: Sustained Weight Loss, Weight Cycling, and Weight Gain During Adulthood and Pancreatic Cancer Incidence in the Women's Health Initiative.

Schwalb, Molly E / Smith-Warner, Stephanie A / Hou, Jianrui / Rohan, Thomas E / Snetselaar, Linda / Luo, Juhua / Genkinger, Jeanine M

American journal of epidemiology

2022 Volume 191, Issue 6, Page(s) 1009–1020

Abstract: Pancreatic cancer (PC) is the fourth leading cause of cancer mortality among women in the United States. Obesity is positively associated with PC risk. Current health recommendations focus on weight maintenance for healthy-weight individuals and weight ... ...

Abstract	Pancreatic cancer (PC) is the fourth leading cause of cancer mortality among women in the United States. Obesity is positively associated with PC risk. Current health recommendations focus on weight maintenance for healthy-weight individuals and weight loss for overweight/obese individuals; however, little research has assessed associations between PC risk and changes in weight throughout the life course. Using prospective cohort study data, we examined the relationship between baseline adulthood weight patterns self-reported between 1993 and 1998 and PC risk in 136,834 postmenopausal women with 873 incident PC cases through September 30, 2015, in the Women's Health Initiative. Hazard ratios (HR) and 95% confidence intervals (CI) were estimated using Cox proportional hazards models, adjusting for age, smoking habits, heavy alcohol consumption, and body mass index. Compared with women with stable weight, no significant associations were found between steady weight gain (HR = 1.01, 95% CI: 0.83, 1.22), sustained weight loss (HR = 1.26, 95% CI: 0.85, 1.87), or weight cycling patterns (HR = 1.08, 95% CI: 0.89, 1.30) and PC. Results were similar when the outcome definition was restricted to pancreatic adenocarcinoma cases. Overall, we did not find evidence to suggest that weight changes in adulthood significantly impact PC risk among postmenopausal women.
MeSH term(s)	Adenocarcinoma ; Adult ; Body Weight ; Female ; Humans ; Incidence ; Obesity/complications ; Obesity/epidemiology ; Pancreatic Neoplasms/complications ; Pancreatic Neoplasms/etiology ; Postmenopause ; Proportional Hazards Models ; Prospective Studies ; Risk Factors ; United States/epidemiology ; Weight Cycling ; Weight Gain ; Weight Loss ; Women's Health
Language	English
Publishing date	2022-01-31
Publishing country	United States
Document type	Journal Article ; Research Support, N.I.H., Extramural
ZDB-ID	2937-3
ISSN	1476-6256 ; 0002-9262
ISSN (online)	1476-6256
ISSN	0002-9262
DOI	10.1093/aje/kwac016
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Article ; Online: Statistical methods for biomarker data pooled from multiple nested case-control studies.

Sloan, Abigail / Smith-Warner, Stephanie A / Ziegler, Regina G / Wang, Molin

Biostatistics (Oxford, England)

2019 Volume 22, Issue 3, Page(s) 541–557

Abstract: Pooling biomarker data across multiple studies allows for examination of a wider exposure range than generally possible in individual studies, evaluation of population subgroups and disease subtypes with more statistical power, and more precise ... ...

Abstract	Pooling biomarker data across multiple studies allows for examination of a wider exposure range than generally possible in individual studies, evaluation of population subgroups and disease subtypes with more statistical power, and more precise estimation of biomarker-disease associations. However, circulating biomarker measurements often require calibration to a single reference assay prior to pooling due to assay and laboratory variability across studies. We propose several methods for calibrating and combining biomarker data from nested case-control studies when reference assay data are obtained from a subset of controls in each contributing study. Specifically, we describe a two-stage calibration method and two aggregated calibration methods, named the internalized and full calibration methods, to evaluate the main effect of the biomarker exposure on disease risk and whether that association is modified by a potential covariate. The internalized method uses the reference laboratory measurement in the analysis when available and otherwise uses the estimated value derived from calibration models. The full calibration method uses calibrated biomarker measurements for all subjects, including those with reference laboratory measurements. Under the two-stage method, investigators complete study-specific analyses in the first stage followed by meta-analysis in the second stage. Our results demonstrate that the full calibration method is the preferred aggregated approach to minimize bias in point estimates. We also observe that the two-stage and full calibration methods provide similar effect and variance estimates but that their variance estimates are slightly larger than those from the internalized approach. As an illustrative example, we apply the three methods in a pooling project of nested case-control studies to evaluate (i) the association between circulating vitamin D levels and risk of stroke and (ii) how body mass index modifies the association between circulating vitamin D levels and risk of cardiovascular disease.
MeSH term(s)	Bias ; Biomarkers ; Calibration ; Case-Control Studies ; Humans ; Research Design
Chemical Substances	Biomarkers
Language	English
Publishing date	2019-12-03
Publishing country	England
Document type	Journal Article ; Research Support, N.I.H., Extramural ; Research Support, N.I.H., Intramural
ZDB-ID	2031500-4
ISSN	1468-4357 ; 1465-4644
ISSN (online)	1468-4357
ISSN	1465-4644
DOI	10.1093/biostatistics/kxz051
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Article ; Online: Partial substitution of red meat or processed meat with plant-based foods and the risk of colorectal cancer.

Tammi, Rilla / Kaartinen, Niina E / Harald, Kennet / Maukonen, Mirkka / Tapanainen, Heli / Smith-Warner, Stephanie A / Albanes, Demetrius / Eriksson, Johan G / Jousilahti, Pekka / Koskinen, Seppo / Laaksonen, Maarit A / Heikkinen, Sanna / Pitkäniemi, Janne / Pajari, Anne-Maria / Männistö, Satu

European journal of epidemiology

2024 Volume 39, Issue 4, Page(s) 419–428

Abstract: Objectives: Shifting from animal-based to plant-based diets could reduce colorectal cancer (CRC) incidence. Currently, the impacts of these dietary shifts on CRC risk are ill-defined. Therefore, we examined partial substitutions of red or processed meat ...

Abstract	Objectives: Shifting from animal-based to plant-based diets could reduce colorectal cancer (CRC) incidence. Currently, the impacts of these dietary shifts on CRC risk are ill-defined. Therefore, we examined partial substitutions of red or processed meat with whole grains, vegetables, fruits or a combination of these in relation to CRC risk in Finnish adults. Methods: We pooled five Finnish cohorts, resulting in 43 788 participants aged ≥ 25 years (79% men). Diet was assessed by validated food frequency questionnaires at study enrolment. We modelled partial substitutions of red (100 g/week) or processed meat (50 g/week) with corresponding amounts of plant-based foods. Cohort-specific hazard ratios (HR) for CRC were calculated using Cox proportional hazards models and pooled together using random-effects models. Adjustments included age, sex, energy intake and other relevant confounders. Results: During the median follow-up of 28.8 years, 1124 CRCs were diagnosed. We observed small risk reductions when red meat was substituted with vegetables (HR 0.97, 95% CI 0.95 - 0.99), fruits (0.97, 0.94 - 0.99), or whole grains, vegetables and fruits combined (0.97, 0.95 - 0.99). For processed meat, these substitutions yielded 1% risk reductions. Substituting red or processed meat with whole grains was associated with a decreased CRC risk only in participants with < median whole grain intake (0.92, 0.86 - 0.98; 0.96, 0.93 - 0.99, respectively; p Conclusions: Even small, easily implemented substitutions of red or processed meat with whole grains, vegetables or fruits could lower CRC risk in a population with high meat consumption. These findings broaden our insight into dietary modifications that could foster CRC primary prevention.
MeSH term(s)	Humans ; Colorectal Neoplasms/epidemiology ; Colorectal Neoplasms/etiology ; Male ; Female ; Middle Aged ; Red Meat/adverse effects ; Finland/epidemiology ; Adult ; Fruit ; Vegetables ; Diet/statistics & numerical data ; Diet/adverse effects ; Meat Products/adverse effects ; Incidence ; Aged ; Animals ; Diet, Vegetarian ; Risk Factors ; Cohort Studies ; Whole Grains
Language	English
Publishing date	2024-01-23
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	632614-6
ISSN	1573-7284 ; 0393-2990
ISSN (online)	1573-7284
ISSN	0393-2990
DOI	10.1007/s10654-024-01096-7
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