Harmonizing Cigar Survey Data Across Tobacco Centers of Regulatory Science, Center for Tobacco Products, and Population Assessment of Tobacco and Health Studies: The Cigar Collaborative Research Group.

INTRODUCTION: Cigars are a popular tobacco product of choice for youth and young adults. Despite growing interest in cigar research, there are gaps in the available literature limiting an ability to set evidence-based policies. Too small research samples, the heterogeneity of types of cigars when asking a single question about use, makes analyzing data difficult. Given the Food and Drug Administration's (FDA's) authority granted in 2016 to regulate cigars, and its popularity, data to better understand use and preference for cigars will help FDA set appropriate regulatory policies. METHODS: We harmonized cigar survey data previously collected by five independent tobacco regulatory science survey research projects. Data supplying participants included three Tobacco Centers of Regulatory Science, one Center for Tobacco Products grantee, and data from Population Assessment of Tobacco and Health (PATH) study's public use dataset. RESULTS: Analyzing 92 data variables from across five studies, and applying a rigorous data harmonization protocol, we report findings on 24 key cigar use variables. The step by step protocol for harmonizing is presented. Selected findings showing strict reproducibility across all five studies reveal youth 17-19 years at highest risk for cigar initiation; relative reproducibility shows males more likely to try cigars than females but with significant differences in magnitude across studies; and areas of inconsistent reproducibility are revealed when evaluating brand preferences. CONCLUSION: Harmonizing data from multiple sources fosters a broader view of the robustness and generalizability of survey data than that from a single source. These observations raise awareness to look for the highest degree of reproducibility among and across data sources to inform policy. IMPLICATIONS: Harmonizing data from discrete datasets provides insights into cigar initiation and use and is presented showing opportunities, challenges, and solutions. Comparing observational data from PATH and four independent research studies provides a best-practices approach and example of data synthesis for the tobacco research community. The dataset of five studies offers a look at the degree of confidence in analyzing harmonized survey results. Variable conclusions raise the need to strive for the highest degree of reproducibility, to best understand the behaviors of cigar users, and allow for the future development of the most effective interventions to alter tobacco use patterns.

Performance and Feasibility of Recalls Completed Using the Automated Self-Administered 24-Hour Dietary Assessment Tool in Relation to Other Self-Report Tools and Biomarkers in the Interactive Diet and Activity Tracking in AARP (IDATA) Study.

BACKGROUND: Automated Self-Administered 24-Hour Dietary Assessment Tool (ASA24) is a self-administered web-based tool designed to collect detailed dietary data at low cost in observational studies. OBJECTIVE: The objectives of this study were to describe, overall and by demographic groups, the performance and feasibility of ASA24-2011 recalls and compare Healthy Eating Index-2015 (HEI-2015) total and component scores to 4-day food records (4DFRs) and food frequency questionnaires (FFQs). DESIGN: Over 12 months, participants completed up to 6 ASA24 recalls, 2 web-based FFQs, and 2 unweighed paper-and-pencil 4DFRs. Up to 3 attempts were made to obtain each ASA24 recall. Participants were administered doubly-labeled water to provide a measure of total energy expenditure and collected two 24-hour urine samples to assess concentrations of nitrogen, sodium, and potassium. PARTICIPANTS/SETTING: From January through September 2012, 1,110 adult members of AARP, 50 to 74 years of age, were recruited from the Pittsburgh, PA, area to participate in the Interactive Diet and Activity Tracking in AARP (IDATA) study. After excluding 33 participants who had not completed any dietary assessments, 531 men and 546 women remained. MAIN OUTCOME MEASURES: Response rates, nutrient intakes compared to recovery biomarkers across each ASA24 administration day, and HEI-2015 total and component scores were measured. STATISTICAL ANALYSES PERFORMED: Means, medians, standard deviations, interquartile ranges, and HEI-2015 total and component scores computed using a multivariate measurement error model are presented. RESULTS: Ninety-one percent of men and 86% of women completed 3 ASA24 recalls. Approximately three-quarters completed 5 or more, higher than the completion rates for 2 4DFRs and 2 FFQs. Approximately, three-quarters of men and 70% of women completed ASA24 on the first attempt; 1 in 5 completed it on the second. Completion rates varied slightly by age and body mass index. Median time to complete ASA24-2011 (current version: ASA24-2020) declined with subsequent recalls from 55 to 41 minutes in men and from 58 to 42 minutes in women and was lowest in those younger than 60 years. Mean nutrient intakes were similar across recalls. For each recording day, energy intakes estimated by ASA24 were lower than energy expenditure. Reported intakes for protein, potassium, and sodium were closer to recovery biomarkers for women, but not for men. Geometric means of reported intakes of these nutrients did not systematically vary across ASA24 administrations, but differences between reported intakes and biomarkers differed by nutrient. Of 100 possible points, HEI-2015 total scores were nearly identical for 4DFRs and ASA24 recalls and higher for FFQs (men: 61, 60, and 68; women: 64, 64, and 72, respectively). CONCLUSIONS: ASA24, a freely available dietary assessment tool for use in large-scale nutrition research, was found to be highly feasible. Similar to previously reported data for nutrient intakes, HEI-2015 total and component scores for ASA24 recalls were comparable to those for 4DFRs, but not FFQs. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03268577 (http://www.clinicaltrials.gov).

Development of a computer-assisted personal interview software system for collection of tribal fish consumption data.

The authors developed a computer-assisted personal interviewing (CAPI) seafood consumption survey tool from existing Pacific NW Native American seafood consumption survey methodology. The software runs on readily available hardware and software, and is easily configured for different cultures and seafood resources. The CAPI is used with a booklet of harvest location maps and species and portion size images. The use of a CAPI facilitates tribal administration of seafood consumption surveys, allowing cost-effective collection of scientifically defensible data and tribal management of data and data interpretation. Use of tribal interviewers reduces potential bias and discomfort that may be associated with nontribal interviewers. The CAPI contains a 24-hour recall and food frequency questionnaire, and assesses seasonal seafood consumption and temporal changes in consumption. EPA's methodology for developing ambient water quality criteria for tribes assigns a high priority to local data. The CAPI will satisfy this guidance objective. Survey results will support development of tribal water quality standards on their lands and assessment of seafood consumption-related contaminant risks and nutritional benefits. CAPI advantages over paper surveys include complex question branching without raising respondent burden, more complete interviews due to answer error and range checking, data transcription error elimination, printing and mailing cost elimination, and improved data storage. The survey instrument was pilot tested among the Quinault Nation in 2006.

Assessment of the accuracy of portion size reports using computer-based food photographs aids in the development of an automated self-administered 24-hour recall.

OBJECTIVE: To assess the accuracy of portion-size estimates and participant preferences using various presentations of digital images. DESIGN: Two observational feeding studies were conducted. In both, each participant selected and consumed foods for breakfast and lunch, buffet style, serving themselves portions of nine foods representing five forms (eg, amorphous, pieces). Serving containers were weighed unobtrusively before and after selection as was plate waste. The next day, participants used a computer software program to select photographs representing portion sizes of foods consumed the previous day. Preference information was also collected. In Study 1 (n=29), participants were presented with four different types of images (aerial photographs, angled photographs, images of mounds, and household measures) and two types of screen presentations (simultaneous images vs an empty plate that filled with images of food portions when clicked). In Study 2 (n=20), images were presented in two ways that varied by size (large vs small) and number (4 vs 8). SUBJECTS/SETTING: Convenience sample of volunteers of varying background in an office setting. STATISTICAL ANALYSES PERFORMED: Repeated-measures analysis of variance of absolute differences between actual and reported portions sizes by presentation methods. RESULTS: Accuracy results were largely not statistically significant, indicating that no one image type was most accurate. Accuracy results indicated the use of eight vs four images was more accurate. Strong participant preferences supported presenting simultaneous vs sequential images. CONCLUSIONS: These findings support the use of aerial photographs in the automated self-administered 24-hour recall. For some food forms, images of mounds or household measures are as accurate as images of food and, therefore, are a cost-effective alternative to photographs of foods.

Challenges in converting an interviewer-administered food probe database to self-administration in the National Cancer Institute Automated Self-administered 24-Hour Recall (ASA24).

The National Cancer Institute (NCI) is developing an automated, self-administered 24-hour dietary recall (ASA24) application to collect and code dietary intake data. The goal of the ASA24 development is to create a web-based dietary interview based on the US Department of Agriculture (USDA) Automated Multiple Pass Method (AMPM) instrument currently used in the National Health and Nutrition Examination Survey (NHANES). The ASA24 food list, detail probes, and portion probes were drawn from the AMPM instrument; portion-size pictures from Baylor College of Medicine's Food Intake Recording Software System (FIRSSt) were added; and the food code/portion code assignments were linked to the USDA Food and Nutrient Database for Dietary Studies (FNDDS). The requirements that the interview be self-administered and fully auto-coded presented several challenges as the AMPM probes and responses were linked with the FNDDS food codes and portion pictures. This linking was accomplished through a "food pathway," or the sequence of steps that leads from a respondent's initial food selection, through the AMPM probes and portion pictures, to the point at which a food code and gram weight portion size are assigned. The ASA24 interview database that accomplishes this contains more than 1,100 food probes and more than 2 million food pathways and will include about 10,000 pictures of individual foods depicting up to 8 portion sizes per food. The ASA24 will make the administration of multiple days of recalls in large-scale studies economical and feasible.

Genes involved in DNA repair and nitrosamine metabolism and those located on chromosome 14q32 are dysregulated in nasopharyngeal carcinoma.

Polymorphisms in nitrosamine metabolism, DNA repair, and immune response genes have been associated with nasopharyngeal carcinoma (NPC). Studies have suggested chromosomal regions involved in NPC. To shed light on NPC etiology, we evaluated host gene expression patterns in 31 NPC and 10 normal nasopharyngeal tissue specimens using the Affymetrix Human Genome U133 Plus 2.0 Array. We focused on genes in five a priori biological pathways and chromosomal locations. Rates of differential expression within these prespecified lists and overall were tested using a bootstrap method. Differential expression was observed for 7.6% of probe sets overall. Elevations in rate of differential expression were observed within the DNA repair (13.7%; P = 0.01) and nitrosamine metabolism (17.5%; P = 0.04) pathways. Differentially expressed probe sets within the DNA repair pathway were consistently overexpressed (93%), with strong effects observed for PRKDC, PCNA, and CHEK1. Differentially expressed probe sets within the nitrosamine metabolism pathway were consistently underexpressed (100%), with strong effects observed for NQ01, CYP2B6, and CYP2E1. No significant evidence of increases in rate of differential expression was seen within the immune/inflammatory pathway. A significant elevation in rate of differential expression was noted for chromosome 4p15.1-4q12 (13.0%; P = 0.04); both overexpression and underexpression were evident (38% and 62%, respectively). An elevation in the rate of differential expression on chromosome 14q32 was observed (11.3%; P = 0.06) with a consistent pattern of gene underexpression (100%; P < 0.0001). These effects were similar when excluding late-stage tumors. Our results suggest that nitrosamine activation and DNA repair are important in NPC. The consistent down-regulation of expression on chromosome 14q32 suggests loss of heterozygosity in this region.

A debriefing session with a nutritionist can improve dietary assessment using food diaries.

The objective of the current study was to evaluate the effect of a debriefing call on nutrient intake estimates using two 3-d food diaries among women participating in the Women's Health and Interview Study (WISH) Diet Validation Study. Subjects were 207 women with complete data and six 24-h recalls (24-HR) by telephone over 8 mo followed by two 3-d food diaries during the next 4 mo. Nutrient intake was assessed using the food diaries before and after a debriefing session by telephone. The purpose of the debriefing call was to obtain more detailed information on the types and amounts of fat in the diet. However, due to the ubiquitous nature of fat in the diet, the debriefing involved providing more specific detail on many aspects of the diet. There was a significant difference in macronutrient and micronutrient intake estimates after the debriefing. Estimates of protein, carbohydrate, and fiber intake were significantly higher and total fat, monounsaturated fat, saturated fat, vitamin A, vitamin C, alpha-tocopherol, folic acid, and calcium intake were significantly lower after the debriefing (P < 0.05). The limits of agreement between the food diaries before and after the debriefing were especially large for total fat intake, which could be under- or overestimated by approximately 15 g/d. The debriefing call improved attenuation coefficients associated with measurement error for vitamin C, folic acid, iron, alpha tocopherol, vitamin A, and calcium estimates. A hypothetical relative risk (RR) = 2.0 could be attenuated to 1.16 for folic acid intake assessed without a debriefing but to only 1.61 with a debriefing. Depending on the nutrients of interest, the inclusion of a debriefing can reduce the potential attenuation of RR in studies evaluating diet disease associations.

Epstein-Barr virus seroreactivity among unaffected individuals within high-risk nasopharyngeal carcinoma families in Taiwan.

Most adults have been infected with EBV. Many studies have indicated that antibodies against specific EBV antigens, particularly IgA antibodies, can be predictive or prognostic of EBV-associated malignancies, such as NPC. We hypothesized that healthy individuals from families with a history of multiple members affected with NPC (who therefore might be genetically susceptible to NPC themselves) might have an EBV antibody profile that is distinct from that seen in healthy individuals from the community at large. To explore this possibility and examine determinants of anti-EBV antibody levels in healthy, high-risk individuals, we evaluated data from 2 parallel studies of NPC in Taiwan, which included 1,229 healthy members of families in which 2 or more individuals were affected with NPC and 320 controls from the community at large. Blood collected from participants was tested for IgA antibodies against EBV VCA and EBNA-1 and for neutralizing antibodies against EBV DNase using standard assays. We observed evidence of familial aggregation of EBV seroreactivity among individuals from high-risk, multiplex NPC families. Anti-VCA IgA and anti-EBNA-1 IgA antibody seroprevalence in unaffected family members of NPC cases was 5-6 times higher than in members of the community (p < 0.01). This elevated seroprevalence among unaffected individuals from high-risk families was observed regardless of the relationship of the unaffected individual to the closest affected relative (siblings, parents, children or spouses). No sociodemographic or environmental factors examined were found to strongly and consistently correlate with elevated seroprevalence, but patterns emerged of increasing seroprevalence among older individuals and among females. Unaffected individuals from high-risk NPC families have elevated anti-EBV IgA antibody titers. The etiologic and clinical implications of this finding remain to be established.

Relative validity of a food frequency questionnaire with a meat-cooking and heterocyclic amine module.

The nutrient and heterocyclic amine (HCA) intake of 165 healthy participants was assessed using a self-administered food frequency questionnaire (FFQ), which included a meat-cooking practices module. A database containing the HCA [2-amino-3,8-dimethylimadazo [4,5-f] quinoxaline (MeIQx) and 2-amino-1-methyl-6-phenylimadazo [4,5-b] pyridine (PhIP)] composition of various types of meat, cooked by different methods and to varying degrees, was developed and validated in conjunction with this module. The relative validity of dietary and HCA intake estimated by the FFQ was investigated using multiple food diaries (3 sets of 4 nonconsecutive day diaries completed over a 3-month period) as the reference method. Crude correlation coefficients of HCA intake assessed by the FFQ and food diaries were 0.43 [95% confidence interval (CI) 0.30-0.55] for MeIQx and 0.22 (95% CI 0.07-0.36) for PhIP intake. Deattenuated correlations were 0.60 (95% CI 0.49-0.69) and 0.36 (95% CI 0.22-0.49), respectively. Absolute MeIQx and PhIP intake was, however, underestimated by the FFQ (21.9 and 78.1 ng/day) compared with the food diaries (34.9 and 263.8 ng/day). The FFQ underestimated total red meat intake, the percentage of consumers, and the median intake of roast/baked and microwaved red meat. PhIP intake was severely underestimated by the FFQ and was most likely because of an underestimation of the percentage of people who cooked chicken using PhIP-producing cooking methods such as broiling and pan-frying. Additionally, the FFQ overestimated the percentage of consumers of baked chicken, a cooking method that produces less PhIP. In conclusion, although the FFQ and meat module underestimated absolute MeIQx and PhIP intake, its ability to rank individuals according to intake was acceptable.

Nasopharyngeal carcinoma and genetic polymorphisms of DNA repair enzymes XRCC1 and hOGG1.

Nitrosamine consumption and polymorphisms in CYP2E1, the product of which is involved in the activation of nitrosamines into reactive intermediates, have been shown to be associated with nasopharyngeal carcinoma (NPC) risk. Given that reactive intermediates created during nitrosamine metabolism are capable of DNA damage, we further hypothesized that differences between individuals in their ability to repair DNA damage might be important in NPC pathogenesis. To evaluate this hypothesis, this study focused on effects of genetic polymorphisms of DNA repair genes hOGG1 and XRCC1 on the development of NPC. We conducted a case-control study to investigate the genotypes of 334 patients with NPC and 283 healthy community controls matched by sex, age, and residence. The PCR-based RFLP assay was used to identify genetic polymorphisms. After adjustment for sex, age, and ethnicity, the odds ratio (OR) of developing NPC for hOGG1 codon 326 genotypes of Ser/Cys and Cys/Cys compared with the Ser/Ser genotype was 1.6 (95% CI, 1.0-2.6). For XRCC1 codon 280 genotypes of Arg/His and His/His compared with the Arg/Arg genotype, the OR was 0.64 (95% CI, 0.43-0.96). Among subjects with putative high-risk genotypes for both hOGG1 and XRCC1, the OR was 3.0 (95% CI, 1.0-8.8). Furthermore, subjects with putative high-risk genotypes for hOGG1, XRCC1, and CYP2E1 had an OR of disease of 25 (95% CI, 3.5-177). Polymorphisms of the DNA repair genes hOGG1 (codon 326) and XRCC1 (codon 280) are associated with an altered risk of NPC. Carriers of multiple putative high-risk genotypes have the highest risk of developing NPC.

Cognitive research enhances accuracy of food frequency questionnaire reports: results of an experimental validation study.

OBJECTIVE: To test whether changing a food frequency questionnaire (FFQ) on the basis of cognitive theory and testing results in greater accuracy. Accuracy was examined for 4 design issues: a) Grouping: asking about foods in a single vs multiple separate questions; b) different forms of a food: asking consumption frequency of each form of a food (eg, skim, 2%, whole milk) vs a nesting approach--asking frequency of the main food (eg, milk) and proportion of times each form was consumed; c) additions (eg, sugar to coffee): asking independent of the main food vs nested under the main foods; d) units: asking frequency and portion size vs frequency of units (eg, cups of coffee). DESIGN: Participants in two randomly assigned groups completed 30 consecutive daily food reports (DFRs), followed by 1 of 2 FFQs that asked about foods consumed in the past month. One was a new, cognitively-based National Cancer Institute (NCI) Diet History Questionnaire; the other was the 1992 NCI-Block Health Habits and History Questionnaire. SUBJECTS/SETTING: 623 participants, age range 25 to 70 years, from metropolitan Washington, DC. Statistical analyses performed Accuracy was assessed by comparing DFR and FFQ responses using categorical (percent agreement) and continuous (rank order correlation, discrepancy scores) agreement statistics. RESULTS: Grouping: accuracy was greater using separate questions. Different forms of food: accuracy was greater using nesting. Additions: neither approach was consistently superior; accuracy of the addition report was affected by accuracy of the main food report. Units: both approaches were similarly accurate. CONCLUSIONS: Accuracy of FFQ reporting can be improved by restructuring questions based on cognitive theory and testing.