Erica R. Pryor

Scientific misconduct from the perspective of research coordinators: a national survey

Objective: To report results from a national survey of coordinators and managers of clinical research studies in the US on their perceptions of and experiences with scientific misconduct. Methods: Data were collected using the Scientific Misconduct Questionnaire-Revised. Eligible responses were received from 1645 of 5302 (31%) surveys sent to members of the Association of Clinical Research Professionals and to subscribers of Research Practitioner, published by the Center for Clinical Research Practice, between February 2004 and January 2005. Findings: Overall, the perceived frequency of misconduct was low. Differences were noted between workplaces with regard to perceived pressures on investigators and research coordinators, and on the effectiveness of the regulatory environment in reducing misconduct. First-hand experience with an incident of misconduct was reported by 18% of respondents. Those with first-hand knowledge of misconduct were more likely to report working in an academic medical setting, and to report that a typical research coordinator would probably do nothing if aware that a principal investigator or research staff member was involved in an incident of misconduct. Conclusion: These findings expand the knowledge on scientific misconduct by adding new information from the perspective of research coordinators. The findings provide some data supporting the influence of workplace climate on misconduct and also on the perceived effectiveness of institutional policies to reduce scientific misconduct.

The Scientific Misconduct Questionnaire—Revised (SMQ-R): Validation and Psychometric Testing

Purpose: The overall purposes of this article are to report the development of a survey instrument, Scientific Misconduct Questionnaire-Revised (SMQ-R) that elicits the perceptions of research coordinators managing clinical trials about the various aspects of scientific misconduct and to present the psychometric analyses for the SMQ-R. Methods: A panel of five researchers and research coordinators reviewed the original SMQ (Rankin and Esteeves, 1997) and suggested an additional 42 items based on the review of the literature and their own experiences in research. The SMQ-Revised (SMQ-R) consists of 68 closed-choice items in six sections and one section with 12 open-ended questions. The SMQ-R was sent to 5302 persons who were members of the Association for Clinical Research Professionals (ACRP) or subscribers to Research Practitioner, published by the Center for Clinical Research Practice (CCRP). Findings: Internal consistency of subscales was assessed with Cronbachs alpha and ranged from .83 to .84. Confirmatory factor analysis was used to test construct validity of the instrument subscales. The factor structure was assessed with the principal factors method, using the squared multiple correlations as initial communality estimates followed by varimax (orthogonal) or biquartimax (oblique) rotations. Analyses revealed five distinct factors among three subscales. Construct validity for the SMQ-R was also assessed by testing hypothesized relationships using the known groups approach. Conclusion: The current effort demonstrated the usefulness of the SMQ-R in obtaining information from a national sample of experienced research coordinators about their perceptions of the prevalence of different types of scientific misconduct and of factors that influence the occurrence of misconduct. The psychometric evaluation of the SMQ-R suggests good internal consistency for most subscales and suggests adequate construct validity of the instrument as a whole. The analyses also suggest that further refinement of the instrument for future studies is warranted.

An innovative approach to training hospital-based clinicians for bioterrorist attacks

The recent attacks of September 11, 2001, and the subsequent dissemination event of anthrax in the United States demonstrated the necessity for hospitals to initiate bioterrorism education for clinicians. Events such as the release of sarin gas into the Tokyo subway by the Aum Shinrikyo cult provided some insight into how quickly emergency medical personnel may be overwhelmed by causalities of unconventional weapons. Educational interventions to prepare hospital-based practitioners for such disasters must fit among the demands of patient care, administrative duties, and continuing education within specialties. In addition, the priority placed on the topic, confusion about reputable resources to consult, and concerns of funding for preparedness training mandate the need for an authoritative, comprehensive, and easily accessible approach. A pilot project supported in part by the Agency for Healthcare Research and Quality was developed to facilitate streamlining of preparedness efforts through the implementation of interactive screen savers as an alternative to traditional educational modalities. This report presents the successful application of this model, which was quantified with pretests and posttests given to users of the system.

Needlestick injuries among nursing staff: Association with shift-level staffing

BACKGROUND Despite the advent of safety measures to protect the health care workforce from contracting blood-borne diseases, nurses still sustain percutaneous injuries. We investigated the association between shift-level staffing and needlestick injuries. METHODS Shift-level staffing, patient occupancy, and acuity data were collected between 2003 and 2006 for the Military Nursing Outcomes Database (MilNOD), a multisite project that examined nurse staffing and adverse patient and nurse events. Data on needlestick injuries were obtained from occupational health/risk management reports and merged with MilNOD specific shift data. Hierarchical logistic regression, with Bayesian modeling, was used to analyze shift-level staffing, patient acuity, and workload as associated with needlestick injuries among nursing staff. RESULTS Of 108,000 shifts, 80 (<0.1%) had at least one needlestick injury occurrence, with 62 (78%) involving a contaminated needle. There was no difference in rate by unit type. Factors associated with needlestick occurrences on shifts were lower RN skill mix, a lower percentage of experienced staff, and fewer nursing care hours per patient per shift. CONCLUSION Needlestick injuries continue to occur. An organizational culture of safety should emphasize the need for adequate staffing on every shift and extra vigilance during periods of high workload.

Relationships among self-efficacy, social support, social problem solving, and self-management in a rural sample living with type 2 diabetes mellitus.

Self-management behaviors are important for control of type 2 diabetes mellitus. Therefore, determining factors that promote effective self-management behaviors may be significant for improving the well-being of patients with type 2 diabetes mellitus. This study examined relationships among self-efficacy, social support, social problem solving, and diabetes self-management behaviors. Further, this study evaluated whether social support and social problem solving were mediators of the relationship between self-efficacy and diabetes self-management behaviors in those living with type 2 diabetes mellitus. Using a cross-sectional, descriptive correlational design, data from a convenience sample of 152 rural people living with type 2 diabetes mellitus were examined. Findings indicated that self-efficacy was a strong predictor of diabetes self-management. The effect of social support on diabetes self-management differed among men and women in the sample. Social support and social problem solving were significantly associated with diabetes self-management in men. Neither social support nor social problem solving were mediators of the relationship between self-efficacy and diabetes self-management in this sample. These findings suggest that nurses need to consider implementing interventions to improve patients’ self-efficacy and potentially influence diabetes self-management.

Evaluation of an online bioterrorism continuing medical education course.

Introduction: Much of the international community has an increased awareness of potential biologic, chemical, and nuclear threats and the need for physicians to rapidly acquire new knowledge and skills in order to protect the publics health. The present study evaluated the educational effectiveness of an online bioterrorism continuing medical education (CME) activity designed to address clinical issues involving suspected bioterrorism and reporting procedures in the United States. Methods: This was a retrospective survey of physicians who had completed an online CME activity on bioterrorism compared with a nonparticipant group who had completed at least 1 unrelated online CME course from the same medical school Web site and were matched on similar characteristics. An online survey instrument was developed to assess clinical and systems knowledge and confidence in recognition of illnesses associated with a potential bioterrorism attack. A power calculation indicated that a sample size of 100 (50 in each group) would achieve 90% power to detect a 10% to 15% difference in test scores between the two groups. Results: Compared with nonparticipant physicians, participants correctly diagnosed anthrax (p = .01) and viral exanthem (p = .01), but not smallpox, more frequently than nonparticipants. Participants knew more frequently than nonparticipants who to contact regarding a potential bioterrorism event (p = .03) Participants were more confident than nonparticipants about finding information to guide diagnoses of patients with biologic exposure (p = .01), chemical exposure (p = .02), and radiation exposure (p = .04). Discussion: An online bioterrorism course shows promise as an educational intervention in preparing physicians to better diagnose emerging rare infections, including those that may be associated with a bioterrorist event, in increasing confidence in diagnosing these infections, and in reporting of such infections for practicing physicians.

Predicting depressive symptoms and self-care in patients with heart failure.

OBJECTIVE To examine relationships among heart failure (HF) physical symptoms, social support, social problem-solving, depressive symptoms, and self-care behaviors in outpatients with HF. METHODS Cross-sectional data were collected from 201 outpatients. Structural equation modeling was used in this preliminary analysis to examine the relationships among the study variables. RESULTS HF physical symptoms and social support were predictors of depressive symptoms and self-care behaviors. Social problem-solving also predicted self-care behaviors. Social support mediated the relationship between HF physical symptoms and depressive symptoms. CONCLUSIONS Social support may influence depressive symptoms and self-care behaviors, whereas social problem-solving may impact self-care behaviors. Future research should examine causality and sub-components of social problem-solving on these outcome variables.

Effect of an Educational Intervention on Cardiovascular Disease Risk Perception among Women with Preeclampsia

OBJECTIVE To promote knowledge and awareness about cardiovascular disease (CVD) among women with recent preeclampsia so that this population may develop more accurate perceptions of their personal CVD risk. DESIGN An exploratory single group, pretest/posttest educational intervention study. SETTING Telephone-based interviews. PARTICIPANTS Sixty-four women with preeclampsia in the most recent pregnancy completed the study. The sample was predominately African American. METHODS Knowledge about CVD and the study covariates (age, race, parity, income, marital status, education, and history of previous preeclampsia) were measured prior to CVD education. Levels of CVD risk perception were measured both before and after the CVD educational intervention. INTERVENTION Structured CVD education by telephone. RESULTS After CVD education, levels of CVD risk perception were significantly higher than at baseline. CONCLUSION As an intervention, CVD education provided by telephone served as a practical and effective approach to contact postpartum women with recent preeclampsia and demonstrated effectiveness in increasing perception of CVD risk.

Do social support, stigma, and social problem-solving skills predict depressive symptoms in people living with HIV? A mediation analysis.

Social support, stigma, and social problem solving may be mediators of the relationship between sign and symptom severity and depressive symptoms in people living with HIV (PLWH). However, no published studies have examined these individual variables as mediators in PLWH. This cross-sectional, correlational study of 150 PLWH examined whether social support, stigma, and social problem solving were mediators of the relationship between HIV-related sign and symptom severity and depressive symptoms. Participants completed self-report questionnaires during their visits at two HIV outpatient clinics in the Southeastern United States. Using multiple regression analyses as a part of mediation testing, social support, stigma, and social problem solving were found to be partial mediators of the relationship between sign and symptom severity and depressive symptoms, considered individually and as a set.

Family relationships in people living with HIV in a city in the USA

Abstract The purpose of this study was to identify relationships of individuals that people living with human immunodeficiency virus/acquired immune deficiency syndrome (PLWH) in a city in the USA include in their family of choice, or chosen family. The convenience sample in this cross-sectional, exploratory study consisted of 150, mostly male and African American PLWH. Participants included partners/lovers most frequently, followed by children, mother, and siblings, and grandparents in their chosen family. Family structures of PLWH in this study are consistent with the diverse nature of families within society.