Researcher Requests for Inappropriate Analysis and Reporting: A U.S. Survey of Consulting Biostatisticians.

Background: Inappropriate analysis and reporting of biomedical research remain a problem despite advances in statistical methods and efforts to educate researchers. Objective: To determine the frequency and severity of requests biostatisticians receive from researchers for inappropriate analysis and reporting of data during statistical consultations. Design: Online survey. Setting: United States. Participants: A randomly drawn sample of 522 American Statistical Association members self-identifying as consulting biostatisticians. Measurements: The Bioethical Issues in Biostatistical Consulting Questionnaire soliciting reports about the frequency and perceived severity of specific requests for inappropriate analysis and reporting. Results: Of 522 consulting biostatisticians contacted, 390 provided sufficient responses: a completion rate of 74.7%. The 4 most frequently reported inappropriate requests rated as "most severe" by at least 20% of the respondents were, in order of frequency, removing or altering some data records to better support the research hypothesis; interpreting the statistical findings on the basis of expectation, not actual results; not reporting the presence of key missing data that might bias the results; and ignoring violations of assumptions that would change results from positive to negative. These requests were reported most often by younger biostatisticians. Limitations: The survey provides information on the reported frequency of inappropriate requests but not on how such requests were handled or whether the requests reflected researchers' maleficence or inadequate knowledge about statistical and research methods. In addition, other inappropriate requests may have been made that were not prespecified in the survey. Conclusion: This survey suggests that researchers frequently make inappropriate requests of their biostatistical consultants regarding the analysis and reporting of their data. Understanding the reasons for these requests and how they are handled requires further study. Primary Funding Source: U.S. Department of Health and Human Services.

Psychosocial impact of anterior dental esthetics on periodontal health, dental caries, and oral hygiene practices in young adults.

This study sought to determine whether the self-perceived image of a young adult's anterior dental esthetics is linked with periodontal health, dental caries, and oral hygiene practices. Two hundred subjects were assessed via a clinical examination, including intraoral photographs. The subjects were questioned about their demographics and oral hygiene practices and given the Psychosocial Impact of Dental Aesthetics Questionnaire (PIDAQ) to measure their self-perceived variables related to dental esthetics. A high PIDAQ score indicates a negative image of one's own dental esthetics, while a low PIDAQ score indicates a positive outlook. A self-perceived negative psychosocial impact of anterior dental esthetics was detected in subjects with higher levels of dental caries and visible gingival inflammation in the anterior region of the mouth.

Skills in assessing the professional literature (SAPL): a 7-year analysis of student EBD performance.

PURPOSE: The primary goal of this project was to describe the level of knowledge acquisition using detailed test performance outcomes of the EBD SAPL curriculum over its first 7-years of implementation at the NYU College of Dentistry. A secondary goal was to compare performance outcomes impact of the full 60 h base SAPL curriculum as taught to 4-year DDS students vs an abbreviated 30 h base SAPL curriculum as taught to 3-year Advanced Placement DDS students. METHODS: The findings for the period 2004-2010 are reported for 1647 dental students (63.6% 4-year DDS students, 36.3% 3-year Advanced Placement DDS students). The database consisted of the score earned by each student on each individual question of the SAPL course's 4 h final examination in which each student read an original research article and answered all questions on the Literature Analysis Form. RESULTS: The major findings were overall high performance by both groups of students (SAPL exam scores of 85.8 vs 83.7, respectively) as well as very similar outcomes between these two student groups on: 1) recognizing research design elements and on interpreting those design elements for clinical application, 2) detailed performance of knowledge within the specific five traditional sections of research articles, and 3) detailed performance across 18 identified research design topics. CONCLUSION: In conclusion, both course formats appear to be highly effective for their respective student groups, but should not be interpreted as evidence favoring the shorter format given the different characteristics of the two student groups.

Influence of scary beliefs about the Tuskegee Syphilis Study on willingness to participate in research.

OBJECTIVES: To assess whether scary/alarming beliefs about details on the Tuskegee Syphilis Study (TSS) are associated with willingness and/or fear to participate in biomedical research. METHODS: Scary beliefs about TSS were examined for 565 Black and White adults who had heard of the TSS. Multivariate analyses by race were used to measure association. RESULTS: No association between scary beliefs and willingness or fear to participate in research was found (P > 0.05). CONCLUSIONS: These findings provide additional evidence that awareness or detailed knowledge about the TSS does not appear today to be a major factor influencing Blacks' willingness to participate in research.

Prenatal tobacco and postbirth second-hand smoke exposure and dental caries in children.

OBJECTIVES: Second-hand smoke (SHS) exposure has been identified as a risk factor for several childhood health problems including dental caries. The purpose of this study was to examine the association of postbirth SHS exposure and dental caries and to determine whether the association is independent of prenatal tobacco exposure, sugar consumption and dental utilization. METHODS: NHANES 2013-2014 and 2015-2016 were used to examine the research question in 1733 children, 4-11 years old with full primary or mixed dentition and serum cotinine levels below 10 ng/mL. Weighted multivariable logistic regression models were developed to examine the independent association between SHS exposure and the prevalence of (i) any dental caries experience and (ii) any decayed teeth. RESULTS: Children exposed to postbirth SHS differed from children not exposed regarding decayed teeth prevalence in the total sample (OR = 1.80, 95% CI: 1.20, 2.71) and mixed dentition (OR = 1.86, 95% CI: 1.20, 2.90) after confounder adjustment. However, no association was found in the primary dentition or between SHS exposure and total caries experience. CONCLUSIONS: The findings partially show that postbirth SHS is associated with dental caries in children. However, the inconsistencies in findings across the three samples and between the two outcome measures, dental caries experience and decayed teeth prevalence raise questions regarding the validity of the hypothesis. Further, the findings suggest that postbirth SHS is likely a marker for true causes of dental caries and the association is likely confounded with other factors associated with dental caries.

Belief in AIDS origin conspiracy theory and willingness to participate in biomedical research studies: findings in whites, blacks, and Hispanics in seven cities across two surveys.

PURPOSE: The purpose of this study was to determine whether a belief in the AIDS origin conspiracy theory is related to likelihood or fear of participation in research studies. METHODS: The Tuskegee Legacy Project Questionnaire was administered via random-digit-dialed telephone interview to black, white, and Hispanic participants in 4 cities in 1999 and 2000 (n = 1,133) and in 3 cities in 2003 (n = 1,162). RESULTS: In 1999, 27.8% of blacks, 23.6% of Hispanics, and 8% of whites (P ≤ .001) reported that it was "very or somewhat likely" that AIDS is "the result of a government plan to intentionally kill a certain group of people by genocide." In 2003, 34.1% of blacks, 21.9% of Hispanics, and 8.4% of whites (P ≤ .001) reported the same. CONCLUSIONS: Whereas blacks and Hispanics were more than 3 times more likely than whites to believe in this AIDS origin conspiracy theory, holding this belief was not associated with a decreased likelihood of participation in, or increased fear of participation in, biomedical research.

Identifying the "vulnerables" in biomedical research: the vox populis from the Tuskegee Legacy Project.

OBJECTIVES: This report presents, for the first time, findings on the vox populis as to who constitutes the "vulnerables in biomedical research" METHODS: The 3-City Tuskegee Legacy Project (TLP) study used the TLP questionnaire as administered via random-digit-dial telephone interviews to 1162 adult Black people, non-Hispanic White people, and two Puerto Rican (PR) Hispanic groups: Mainland United States and San Juan (SJ) in three cities. The classification schema was based upon respondents' answers to an open-ended question asking which groups of people were the most vulnerable when participating in biomedical research. RESULTS: Subjects provided 749 valid open-ended responses, which were grouped into 29 direct response categories, leading to a four-tier classification schema for vulnerability traits. Tier 1, the summary tier, had five vulnerability categories: (1) Race/ ethnicity; (2) Age; (3) SES; (4) Health; and, (5) Gender. Black people and Mainland United States PR Hispanics most frequently identified Race/Ethnicity as a vulnerability trait (42.1 percent of Black people and 42.6 percent of Mainland United States. PR Hispanics versus 15.4 percent of White people and 16.7 percent of SJ R Hispanics) (P < 0.007), while White people and SJ PR Hispanics most frequently identified Age (48.3 percent and 29.2 percent) as a vulnerability trait. CONCLUSIONS: The response patterns on "who was vulnerable" were similar for the two minority groups (Black people and Mainland US PR Hispanics), and notably different from the response patterns of the two majority groups (White people and SJ PR Hispanics). Further, the vox populis definition of vulnerables differed from the current official definitions as used by the U.S. federal government.

PCR detection of Streptococcus mutans and Aggregatibacter actinomycetemcomitans in dental plaque samples from Haitian adolescents.

Streptococcus mutans and Aggregatibacter actinomycetemcomitans are oral pathogens associated with dental caries and periodontitis, respectively. The aim of this study was to determine the colonization of these two microorganisms in the dental plaque of a group of Haitian adolescents using two different polymerase chain reaction (PCR) methods, standard PCR, and quantitative real-time PCR (qPCR) assays. Fifty-four pooled supra-gingival plaque samples and 98 pooled sub-gingival plaque samples were obtained from 104 12- to19-year-old rural-dwelling Haitians. The total genomic DNA of bacteria was isolated from these samples, and all participants also received caries and periodontal examinations. Caries prevalence was 42.2%, and the mean decayed, missing, and filled surface (DMFS) was 2.67 ± 5.3. More than half of the adolescents (53.3%) experienced periodontal pockets (Community Periodontal Index score ≥3). S. mutans was detected in 67.3% by qPCR and 38.8% by PCR of the supra-gingival plaque samples (p < 0.01), and 36.6% by qPCR and 8.1% by PCR of the sub-gingival samples (p < 0.01). A. actinomycetemcomitans was detected in 85.1% by qPCR and 44.0% by PCR of the sub-gingival samples (p < 0.01), but the prevalence was similar, 67.3% by qPCR and 59.2% by PCR, in the supra-gingival plaque samples. Neither age nor gender was significantly correlated to the bacterial colonization. The results demonstrated a moderate-to-high prevalence of S. mutans and A. actinomycetemcomitans in the Haitian adolescent population, and qPCR is more sensitive than standard PCR in field conditions. These findings suggest that qPCR should be considered for field oral epidemiologic studies and may be necessary in investigations having major logistic challenges.

Self-reported willingness to have cancer screening and the effects of sociodemographic factors.

BACKGROUND: The relative effects of race/ethnicity and other sociodemographic factors, compared to those of attitudes and beliefs on willingness to have cancer screening, are not well understood. METHODS: We conducted telephone interviews with 1148 adults (22% Hispanic, 31% African American, and 46% white) [corrected] from 3 cities in mainland United States and Puerto Rico. Respondents reported their sociodemographic characteristics, attitudes about barriers and facilitators of cancer screening, and willingness to have cancer screening under 4 scenarios: when done in the community vs one's doctor's office, and whether or not one had symptoms. RESULTS: Racial/ethnic minority status, age, and lower income were frequently associated with increased willingness to have cancer screening, even after including attitudes and beliefs about screening. Having screening nearby was important for community screening, and anticipation of embarrassment from screening for when there were no cancer symptoms. Associations varied across 4 screening scenarios, with the fewest predictors for screening by one's doctor when there were symptoms. CONCLUSIONS: Sociodemographic characteristics not only were related to willingness to have cancer screenings in almost all cases, but were generally much stronger factors than attitudinal barriers and facilitators. Cancer screening campaigns should affect attitudinal change where possible, but should also recognize that targeting screening to specific population groups may be necessary.

Development of the Knowledge Related to Oral Health Literacy for Spanish Speakers Scale.

The Hispanic population has one of the highest levels of untreated oral disease of any linguistic or ethnic population in the United States. Research examining the factors leading to such outcomes is limited. Since health literacy has been identified as a mediator of health disparities, it is important to identify the most appropriate tool to assess it. The Knowledge Related to Oral Health Literacy model for Spanish speakers (KROHL-S) is an inclusive framework to evaluate oral health knowledge and other modifiable factors at the individual level among the Hispanic population as related to oral health literacy. KROHL-S intends to provide concrete, practical information to help customize interpersonal interactions and educational experiences to individuals' needs and capabilities. The questionnaire that will allow the creation of the KROHL-S scale consists of orally administered open-ended questions to measure knowledge that is condition specific (caries, periodontal disease, oral cancer, tooth loss, and malocclusion) and domain that is knowledge specific (identification of condition, causes, prevention, treatment, general knowledge). Implementation of the KROHL-S framework will provide in depth information that could be shared among health care providers and the creation of patient-centred initiatives.

Geriatric Health Experts Validate Oral Neglect Timelines for the Institutionalized Elderly.

The purpose of this follow-up Delphi survey was to have an expert panel of 31 academic geriatric physicians, geriatric nurses, and medical directors of nursing homes evaluate the original timeline set to avoid oral neglect of nursing home residents. The Oral Neglect in Institutionalized Elderly (ONiIE) timelines defined oral neglect as having occurred when >7 days for acute oral diseases/conditions or >34 days for chronic oral disease/conditions had passed between initial diagnosis and offering access to dental care to the long-term care (LTC) nursing home resident. The results of this follow-up Delphi survey validated those originally defined ONiIE timelines as 90% of this panel agreed with the original timelines. This ONiIE definition adds a broad-based validation for the ONiIE timelines for setting an oral health standard of care for institutionalized elderly residents of nursing homes and should now be used to protect the vulnerable elderly residing in LTC nursing homes.

Development of a tongue-tie case definition in newborns using a Delphi survey: The NYU-Tongue-Tie Case Definition.

OBJECTIVE: The primary purpose of this study was to develop an operational definition of the oral condition of ankyloglossia (also called tongue-tie) that occurs in newborns (i.e., age birth-6 months) and that could consistently be used in research studies. STUDY DESIGN: This 4-round Delphi survey developed the consensus New York University-Tongue-Tie Case Definition (NYU-TTCD) by using a panel of ankyloglossia treatment experts. RESULTS: This tongue-tie case definition (TTCD) was carefully created in a step-wise manner from the bottom up by expert panelists over 4 rounds of inquiry. As a functioning case definition, it offers the diagnostician 2 separate pathways to identifying a newborn as being tongue tied. One pathway requires but a single pathognomonic anatomic feature, and the other pathway requires a single functional deficit accompanied by at least 2 of 12 other diagnostic items (functional, anatomic, or behavioral). CONCLUSIONS: This Delphi survey, as administered to a panel of ankyloglossia treatment experts, produced the first consensus case definition of tongue-tie for newborns (i.e., age birth-6 months) for use in epidemiologic research studies ranging from descriptive prevalence studies to clinical trials. Next-step studies should establish the validity, reliability, and utility of this novel NYU-TTCD case definition for epidemiologic and clinical purposes.

Identifying the Tuskegee Syphilis Study: implications of results from recall and recognition questions.

BACKGROUND: This analysis assessed whether Blacks, Whites and Puerto-Rican (PR) Hispanics differed in their ability to identify the Tuskegee Syphilis Study (TSS) via open-ended questions following lead-in recognition and recall questions. METHODS: The Tuskegee Legacy Project (TLP) Questionnaire was administered via a Random-Digit Dial (RDD) telephone survey to a stratified random sample of Black, White and PR Hispanic adults in three U.S. cities. RESULTS: The TLP Questionnaire was administered to 1,162 adults (356 African-Americans, 313 PR Hispanics, and 493 non-Hispanic Whites) in San Juan, PR, Baltimore, MD and New York City, NY. Recall question data revealed: 1) that 89% or more of Blacks, Whites, and PR Hispanics were not able to name or definitely identify the Tuskegee Syphilis Study by giving study attributes; and, 2) that Blacks were the most likely to provide an open-ended answer that identified the Tuskegee Syphilis Study as compared to Whites and PR Hispanics (11.5% vs 6.3% vs 2.9%, respectively) (p

Exploring the "legacy" of the Tuskegee Syphilis Study: a follow-up study from the Tuskegee Legacy Project.

The purpose of this follow-up 2003 3-City Tuskegee Legacy Project (TLP) Study was to validate or refute our prior findings from the 1999-2000 4 City TLP Study, which found no evidence to support the widely acknowledged "legacy" of the Tuskegee Syphilis Study (TSS), ie, that blacks are reluctant to participate in biomedical studies due to their knowledge of the TSS. The TLP Questionnaire was administered in this random-digit-dial telephone survey to a stratified random sample of 1162 black, white, and Puerto Rican Hispanic adults in 3 different US cities. The findings from this current 3-City TLP Study fail to support the widely acknowledged "legacy" of the TSS, as awareness of the TSS was not statistically associated with the willingness to participate in biomedical studies. These findings, being in complete agreement with our previous findings from our 1999-2000 4-City TLP, validate those prior findings.

Awareness of the Tuskegee Syphilis Study and the US presidential apology and their influence on minority participation in biomedical research.

OBJECTIVES: We compared the influence of awareness of the Tuskegee Syphilis Study and the presidential apology for that study on the willingness of Blacks, non-Hispanic Whites, and Hispanics to participate in biomedical research. METHODS: The Tuskegee Legacy Project Questionnaire was administered to 1133 adults in 4 US cities. This 60-item questionnaire addressed issues related to the recruitment of minorities into biomedical studies. RESULTS: Adjusted multivariate analysis showed that, compared with Whites, Blacks were nearly 4 times as likely to have heard of the Tuskegee Syphilis Study, more than twice as likely to have correctly named Clinton as the president who made the apology, and 2 to 3 times more likely to have been willing to participate in biomedical studies despite having heard about the Tuskegee Syphilis Study (odds ratio [OR]=2.9; 95% confidence interval [CI]=1.4, 6.2) or the presidential apology (OR=2.3; 95% CI=1.4, 3.9). CONCLUSIONS: These marked differences likely reflect the cultural reality in the Black community, which has been accustomed to increased risks in many activities. For Whites, this type of information may have been more shocking and at odds with their expectations and, thus, led to a stronger negative impact.

Willingness to participate in cancer screenings: blacks vs whites vs Puerto Rican Hispanics.

BACKGROUND: In the United States, blacks and Hispanics have lower cancer screening rates than whites have. Studies on the screening behaviors of minorities are increasing, but few focus on the factors that contribute to this discrepancy. This study presents the self-reported willingness by blacks, Puerto Rican Hispanics, and non-Hispanic whites to participate in cancer screenings in differing cancer screening situations. METHODS: The Cancer Screening Questionnaire (CSQ), a 60-item questionnaire, was administered via random-digit-dial telephone interviews to adults in three cities: Baltimore, Maryland; New York, New York; and, San Juan, Puerto Rico. RESULTS: The 1,148 participants in the CSQ study sample consisted of 355 blacks, 311 Puerto Rican Hispanics, and 482 non-Hispanic whites. Response rates ranged from 45% to 58% by city. Multivariable logistic regression analyses revealed that blacks and Puerto Ricans were often more likely (OR 2.0-3.0) and never less likely than whites to self-report willingness to participate in cancer screenings regardless of who conducted the cancer screening, what one was asked to do in the cancer screening, or what type of cancer was involved (with the exception of skin cancer where blacks, compared with whites, had an OR of 0.5). CONCLUSIONS: The findings from this study provide evidence that blacks and Hispanics self-report that they are either as willing or more willing than whites to participate in cancer screening programs.

Participation in biomedical research studies and cancer screenings: perceptions of risks to minorities compared with whites.

BACKGROUND: This analysis was conducted to determine whether there is a difference among blacks, Hispanics, and whites in their perception of risks associated with participating in either a biomedical study or a cancer screening. METHODS: The Tuskegee Legacy Project Questionnaire, which focused on research subject participation, was administered in two different surveys (1999-2000 and 2003) in seven cities. The Cancer Screening Questionnaire was administered in 2003 in three cities. RESULTS: The study sample across the three surveys consisted of 1,064 blacks, 781 Hispanics, and 1,598 non-Hispanic whites. Response rates ranged from 44% to 70% by city. Logistic regression analyses, adjusted for age, sex, education, income, and city, revealed that blacks and Hispanics each self-reported that minorities, compared with whites, are more likely to be "taken advantage of" in biomedical studies and much less likely to get a "thorough and careful examination" in a cancer screening (odds ratios ranged from 3.6 to 14.2). CONCLUSIONS: Blacks and Hispanics perceive equally high levels of risk for participating in cancer screening examinations and for volunteering to become research subjects in biomedical studies. This perception provides a strong message about the need to overtly address this critical health disparities issue.

Effect of childhood malnutrition on salivary flow and pH.

INTRODUCTION: While protein-energy malnutrition may have multiple effects on oral tissues and subsequent disease development, reports of the effect of malnutrition on the human salivary glands are sparse. METHODS: A retrospective cohort study of the effect of early childhood protein-energy malnutrition (EC-PEM) and adolescent nutritional status on salivary flow and pH was conducted with rural Haitian children, ages 11-19 years (n=1017). Malnutrition strata exposure cohorts were based on 1988-1996 weight-for-age records which covered the birth through 5-year-old period for all subjects. Then, data on current anthropometrical defined nutritional status categories, stimulated and unstimulated salivary flow rates, and salivary pH were collected for the same subjects of 11-19 years old during field examinations in the summer of 2005. Multivariate analysis of variance (MANOVA) was used for the analyses. RESULTS: Stimulated and unstimulated salivary flow rates were reduced at statistically significant levels in subjects who had experienced severe malnutrition in their early childhood or who had continuing nutrition stress which resulted in delayed growth, as measured at ages 11-19 years. Salivary pH demonstrated little clinically meaningful variability between malnourished and nonmalnourished groups. CONCLUSION: This study is the first to report of a continuing effect on diminished salivary gland function into adolescence as a result of early childhood malnutrition (EC-PEM) and suggests that exocrine glandular systems may be compromised for extended periods following EC-PEM, which may have important implications for the body's systemic antimicrobial defences.

The legacy of the Tuskegee Syphilis Study: assessing its impact on willingness to participate in biomedical studies.

The phrase, 'legacy of the Tuskegee Syphilis Study', is sometimes used to denote the belief that Blacks are more reluctant than Whites to participate in biomedical research studies because of the infamous study of syphilis in men run by the U.S. Public Health Service from 1932-72. This paper is the first to attempt to assess directly the accuracy of this belief within a multi-city, multi-racial, large-scale, detailed random survey. We administered the Tuskegee Legacy Project (TLP) Questionnaire to 826 Blacks and non-Hispanic White adults in three U.S. cities. While Blacks had higher levels of general awareness of the Tuskegee Syphilis Study, there was no association between either awareness or detailed knowledge of the Tuskegee Syphilis Study and willingness to participate in biomedical research, either for Blacks or Whites observed in our survey. While this study refutes the notion that there is a direct connection between detailed knowledge of the Tuskegee Syphilis Study and willingness to participate in biomedical research, it does not assess the broader question of whether and how historical events influence people's willingness to participate in research. Future studies should explore this.