Frequency of concealment, fabrication and falsification of study data by deceptive subjects.

PURPOSE: Many studies have found evidence that research subjects engage in deceptive practices while participating in health-related studies. Little is known, however, about how often subjects use deception and the percentage of studies a typical subject will contaminate with false data. This study examined the frequency of use of different types of deception among a sample of subjects who admit to using deception. METHODS: A sample of 59 subjects who had participated in at least two health-related studies in the past 12 months and admitted to using deception in at least one were interviewed. Subjects were asked a series of questions about concealing information and fabricating information to gain entry into studies. Subjects were also asked about falsifying data after being enrolled in a health-related study. All study data reported pertains to only subjects who reported using deception in health-related studies and is based on subjects' study participation only within the last 12 months from the date of the interview. RESULTS: Subjects who conceal information in order to enroll in trials reported using concealment in about two thirds (67%) of the trials they participated in over the past 12 months. On average, these subjects' use of concealment was highest for mental health information (58% of studies) and physical health information (57% of studies). The average frequency of fabricating information in order to enroll in trials was 53% with exaggerating health symptoms (45% of studies) and pretending to have a health condition (39% of studies) as the two most widely used strategies. Subjects who falsify study data after enrollment reported doing so 40% of the time. These subjects falsely reported improvement in the health condition being studied in 38% of the trials they took part in. Subjects who admitted to throwing away study medication to create the appearance of compliance reported doing so 32% of the time. LIMITATIONS: Although this study provides evidence that subjects who admit to using deception contaminate a high percentage of studies, larger and more geographically diverse samples are needed to understand the full extent of the problem of deceptive subjects in research. Regional economic, cultural, or organizational factors may be related to the rate of subjects using deception. It is also possible that this sample underrepresents the use of deception as there are likely subjects who use deception that would be unwilling to admit the extent of this behavior. CONCLUSION: Deceptive subject's behavior poses a threat to the integrity of research findings. Given that deceptive subjects contaminate a high percentage of studies they take part in by concealing information, fabricating information, and falsifying study data after enrollment, efforts to identify and exclude these subjects is important to the integrity of research findings. Strategies to exclude deceptive subjects from health research should be used to inform study designs. Widespread adoption of research subject identity registries could greatly reduce the scope of studies that a single deceptive subject could contaminate. Technological solutions that provide an objective measure of medication compliance may be valuable tools for limiting fraudulent reports of compliance.

U.S. Department of Health adverse event reporting policies for nursing homes.

The objectives of this study were to describe state policies for the frequency of adverse event reporting and follow-up that occurs in U.S. nursing homes, and to identify the health information technology used to facilitate these processes. The study was conducted using a mailed survey to the Departments of Health (DOH) in all 50 states, specifically the department that is responsible for the oversight and regulation of nursing home care. Thirty-two state DOH representatives participated. The primary variables examined were (1) which incidents were most commonly reported to state DOH and (2) whether or not they were followed up with a surveyor visit to the nursing home. There was wide variation in incident reporting processes across all states and lack of a standardized process. Abuse is the only adverse event that almost always is required to be reported to the state DOH and has the highest incidence of follow-up with a surveyor visit. Improving and standardizing adverse event reporting systems is a necessary strategy to enhance patient safety in nursing homes. This study provides an important step by increasing our knowledge base of the current state of adverse event reporting policies and processes at the state level.

A cross-sectional study on tobacco use and dependence among women: Does menthol matter?

BACKGROUND: The question of whether mentholation of cigarettes enhances tobacco dependence has generated conflicting findings. Potential mediating factors in a putative relationship between menthol use and tobacco dependence may include race and gender. While an association between menthol use and dependence is mixed, research on the role of race solely among women smokers is scarce. This study examined whether women menthol smokers have higher tobacco use and dependence than non-menthol smokers. Further, the study investigated differences between White and African American smokers. METHODS: A cross-sectional study was conducted among 928 women seeking tobacco dependence treatment in Boston, Massachusetts. Measures obtained included preferred brand and menthol content, dependence markers (cigarettes per day (CPD); time to first cigarette in the morning; number of and longest previous quit attempts) and smoking history (age of initiation; years smoking; menthol or non-menthol cigarette preference). Analysis of variance (ANOVA) was used to detect interactions between menthol preference by race for continuous variables, and Pearson's chi-squared test was used for analyses with dichotomous variables. RESULTS: A greater proportion of menthol smokers smoked their first cigarette within five minutes of waking (p < 0.01) and were less likely to have a previous quit attempt longer than 90 days (p < 0.01). ANOVAs revealed no main effects for menthol preferences. However, African American smokers smoked fewer CPD (p<.001), started smoking later in life (p= .04), and had been smoking the same brand for longer (p= .04). CONCLUSIONS: Women menthol smokers showed signs of greater tobacco dependence than non-menthol smokers. African Americans smoked fewer CPD but nevertheless had evidence of greater dependence.

The relationship between media exposure and antifat attitudes: the role of dysfunctional appearance beliefs.

This study examined the relationship between media exposure, antifat attitudes, and body dissatisfaction, as well as the mediating effect of dysfunctional appearance beliefs. A sample of 112 women completed surveys measuring media exposure, antifat attitudes, body dissatisfaction, and dysfunctional beliefs about appearance. It was found that time spent reading fashion magazines was positively correlated with antifat attitudes and that this relationship was mediated by dysfunctional beliefs about appearance. Measures of antifat attitudes and body dissatisfaction were both found to be correlated with endorsement of dysfunctional beliefs about appearance and body mass index. Results suggest that time spent reading fashion magazines may be related to antifat attitudes through dysfunctional appearance beliefs.