Assessing clinical investigators' perceptions of relevance and competency of clinical trials skills: An international AIDS Malignancy Consortium (AMC) study.

INTRODUCTION: The AIDS Malignancy Consortium (AMC) conducts clinical trials of therapeutic and prevention strategies for cancer in people living with HIV. With its recent expansion to Sub-Saharan Africa and Latin America, there was a need to increase the competence of clinical investigators (CIs) to implement clinical trials in these regions. METHODS: AMC CIs were invited to complete a survey to assess role-relevance and self-perceived competence based on the Joint Task Force for Clinical Trials Competency domains. RESULTS: A total of 40 AMC CIs were invited to complete the questionnaire and 35 responded to the survey. The data management and informatics and engaging with communities' domains were lowest in the average proportion of CIs rating themselves high (scores of 3-4) for self-perceived competency (46.6% and 44.2%) and role-relevance (61.6% and 67.5%), whereas, the ethical and participant safety considerations domain resulted in the highest score for competency (86.6%) and role-relevance (93.3%). In the scientific concepts and research design domain, a high proportion rated for competency in evaluating study designs and scientific literature (71.4% and 74.3%) but a low proportion for competency for designing trials and specimen collection protocols (51.4% and 54.3%). CONCLUSIONS: Given the complexity of AMC clinical research, these results provide evidence of the need to develop training for clinical research professionals across domains where self-perceived competence is low. This assessment will be used to tailor and prioritize the AMC Training Program in clinical trial development and management for AMC CIs.

Participant characteristics and clinical trial decision-making factors in AIDS malignancy consortium treatment trials for HIV-infected persons with cancer (AMC #S006).

BACKGROUND: Overall, people living with HIV/AIDS (PLWHA) are living longer, but compared with the general population, they are at elevated risk for numerous AIDS-defining and non-AIDS-defining cancers. The AIDS Malignancy Consortium (AMC) is dedicated to conducting clinical trials aimed at prevention and treatment of cancers among PLWHA. OBJECTIVE: To examine patient-level characteristics and perceptions that influence decision-making regarding AMC treatment trial participation. METHODS: PLWHA diagnosed with cancer or anal high-grade intraepithelial neoplasia who were ≥18 years old and offered participation on a therapeutic AMC clinical trial were eligible. Participants completed a 17-item survey assessing sociodemographic and other factors potentially influencing decision-making regarding trial participation. RESULTS: The sample of 67 participants was mainly male (n = 62, 92.5%), non-Hispanic (89.5%) and white (67.2%), with a mean age of 48.3 years. About half of participants were screened for lymphoma studies. Nearly all (98.5%) of the participants learned about AMC clinical trials from a medical provider, most (73.1%) knew little about clinical trials in general, and half decided on trial participation on their own. Altruism was the most frequently cited reason for trial participation. Participant recommendations for improving AMC trial accrual included systems changes to speed access to clinical trials and reduce participant burden. CONCLUSIONS: This formative study highlights the perceived benefits to others, i.e. altruism, as an important factor in trial decision-making, little knowledge about clinical trials in general, and the role of physicians in informing participants about clinical trials. Future research should address knowledge barriers and explore systems- and provider-level factors affecting accrual to AMC trials.

Implementation of a tailored kiosk-based injury prevention program in pediatric primary care.

This study identified behavioral and organizational barriers and facilitators related to the implementation of a clinic-based pediatric injury prevention program. Safe N' Sound (SNS), an evidence-based tailored injury prevention program designed for pediatric primary care, was implemented in five pediatric clinics in North Carolina. Office managers participated in structured interviews; health care providers participated in focus groups. Waiting room observations were conducted in participating clinics. Qualitative data captured perceptions of program implementation, including experience in integrating the program into clinical practice, usage by parents and providers, and recommendations for improving implementation. Reported facilitators of program use included usefulness and likeability of customized materials by parents and physicians and alignment with clinic priorities for injury prevention. Barriers included perceived staff burden despite the program's low staff requirements. Consequently, practices experienced difficulty integrating the program into the waiting room environment and within existing staff roles. Recommendations included formalizing staff roles in implementation. Waiting room observations supported greater technology maintenance and staff involvement. Findings suggest a dynamic relationship between program implementation and the adopting organization. In addition to considering characteristics of the intervention, environment, and personnel in intervention development, implementation may require customization to the organization's capacity.

Measuring the impact of practice-based research networks on member dentists in the Collaboration on Networked Dental and Oral Health Research, CONDOR.

OBJECTIVES: The National Institute of Dental and Craniofacial Research funded three practice-based research networks (PBRNs), NW-PRECEDENT, PEARL and DPBRN to conduct studies relevant to practicing general dentists. These PBRNs collaborated to develop a questionnaire to assess the impact of network participation on changes in practice patterns. This report presents results from the initial administration of the questionnaire. METHODS: Questionnaires were administered to network dentists and a non-network reference group. Practice patterns including caries diagnosis and treatment, pulp cap materials, third molar extraction, dentine hypersensitivity treatments and endodontic treatment and restoration were assessed by network, years in practice, and level of network participation. Test-retest reliability of the questionnaire was evaluated. RESULTS: 950 practitioners completed the questionnaire. Test-retest reliability was good-excellent (kappa>0.4) for most questions. Significant differences in responses by network were not observed. The use of caries risk assessment forms differed by both network participation (p<0.001) and years since dental degree (p=0.026). Recent dental graduates are more likely to recommend third molar removal for preventive reasons (p=0.003). CONCLUSIONS: Practitioners in the CONDOR research networks are similar to their US colleagues. As a group, however, these practitioners show a more evidence-based approach to their practice. Dental PBRNs have the potential to improve the translation of evidence into daily practice. Designing methods to assess practice change and the associated factors is essential to addressing this important issue.

Information-seeking behaviors of dental practitioners in three practice-based research networks.

Research on the information-seeking behaviors of dental practitioners is scarce. Knowledge of dentists' informationseeking behaviors should advance the translational gap between clinical dental research and dental practice. A cross-sectional survey was conducted to examine the self-reported information-seeking behaviors of dentists in three dental practice-based research networks (PBRNs). A total of 950 dentists (65 percent response rate) completed the survey. Dental journals and continuing dental education (CDE) sources used and their influence on practice guidance were assessed. PBRN participation level and years since dental degree were measured. Full-participant dentists reported reading the Journal of the American Dental Association and General Dentistry more frequently than did their reference counterparts. Printed journals were preferred by most dentists. A lower proportion of full participants obtained their CDE credits at dental meetings compared to partial participants. Experienced dentists read other dental information sources more frequently than did less experienced dentists. Practitioners involved in a PBRN differed in their approaches to accessing information sources. Peer-reviewed sources were more frequently used by full participants and dentists with fifteen years of experience or more. Dental PBRNs potentially play a significant role in the dissemination of evidence-based information. This study found that specific educational sources might increase and disseminate knowledge among dentists.

Level of oral health impacts among patients participating in PEARL: a dental practice-based research network.

OBJECTIVES: To determine whether participants of a dental practice-based research network (PBRN) differ in their level of oral health impact as measured by the Oral Health Impact Profile (OHIP) questionnaire. METHODS: A total of 2410 patients contributed 2432 OHIP measurements (median age = 43 years; interquartile range = 28) were enrolled in four dental studies. All participants completed the Oral Health Impact Profile (OHIP-14) during a baseline visit. The main outcome of this study was the level of oral health impact, defined as follows: no impact ('Never' reported on all items); low ('Occasionally' or 'Hardly ever' as the greatest frequency score reported on any item); and high ('Fairly often' or 'Very often' as the greatest frequency reported on any item). Polychotomous logistic regression was used to develop a predictive model for the level of oral health impact considering the following predictors: patient's age, gender, race, practice location, type of dentist, and number of years the enrolling dentist has been practicing. RESULTS: A high level of oral health impacts was reported in 8% of the sample; almost a third (29%) of the sample reported a low level of impacts, and 63% had no oral health impacts. The prevalence of impacts differed significantly across protocols (P < 0.001). Women were more likely to be in the high oral impact group than in the no impact group compared to men (OR = 1.46; 95% CI = 1.06-1.99). African Americans were more likely to report high oral impacts when compared to other racial/ethnic groups (OR = 2.11; 95% CI = 1.26-3.55). Protective effects for being in the high or in the low-impact groups were observed among patients enrolled by a solo practice (P < 0.001) or by more experienced dentists (P = 0.01). A small but highly significant statistical association was obtained for patient age (P < 0.001). In the multivariate model, patient's age, practice size, and gender were found to jointly be significant predictors of oral health impact level. CONCLUSIONS: Patients' subjective report of oral health impact in the clinical setting is of importance for their health. In the context of a dental PBRN, the report of oral health-related quality of life (OHRQoL) was different across four dental studies. The observed findings validate the differential impact that oral health has on the patients' perception of OHRQoL particularly among specific groups. Similar investigations to elucidate the factors associated with patient's report of quality of life are warranted.

Reach of a kiosk-based pediatric injury prevention program.

While controlled trials are important for determining the efficacy of public health programs, implementation studies are critical to guide the translation of efficacious programs to general practice. To implement an evidence-based injury prevention program and examine program use and completion rates in two implementation phases, Safe N' Sound, an evidence-based program, was implemented in five pediatric clinics. Data on program use were collected from program files and patient census data. Program use averaged 12.1% of eligible patients during implementation and 9.5% during the continuation phase. Program completion averaged 9.7% and 6.5%, respectively. Findings from this study can inform the dissemination of evidence-based public health programs, particularly in practice-based clinical settings.

Nicotine replacement therapy use among adolescent smokers seeking cessation treatment.

OBJECTIVE: To examine the correlates of prior nicotine replacement therapy (NRT) in an urban sample of adolescent smokers seeking smoking cessation treatment. DESIGN: Adolescents were recruited via radio, TV and print advertisements for participation in treatment studies. Participants completed a structured interview usinga prescreeningquestionnaire. SETTING: Data were collected via a telephone interview by trained research personnel. PARTICIPANTS: A sample (N=1879) cessation treatment-seeking volunteer boys (38.2%) and girls (61.8%) aged 12 to 17 years, from a diverse ethnic background residing in the Baltimore, Maryland metropolitan area. INTERVENTIONS: No interventions were used in this observational study. MAIN OUTCOME MEASURES: Use of NRT in adolescents stratified by age, Fagerstrom Test of Nicotine Dependence (FTND), and race/ethnicity. RESULTS: The sample had a mean FTND score of 5.7 (SD = 2.2). About 41% smoked 11 to 20 cigarettes per day. Adolescent smokers who had used NRT were statistically but only marginally older than those who had not (15.9 vs 15.7 years; t-test= -2.60, P=0.01). FTND score, a measure of nicotine dependence, was higher among those who had used NRT (6.0 vs 5.6; t-test= -3.37, P= .001). African American adolescents were less likely to have used NRT than their European American counterparts (33.0% vs 61.2%; chi2=16.09, P<.003). After stepwise logistic regression analyses, age, FTND and race/ethnicity remained predictors of NRT use. CONCLUSION: Our results show differences in NRT use patterns based on age, FTND, and race/ethnicity. European American youths are more likely than their 'other' counterparts to use NRT, after adjusting for age and smoking severity, whereas, African American youth are less likely than their 'other' counterparts to use NRT. These findings suggest racial/ethnic disparities in accessing smoking cessation modalities among adolescents. Further research is needed to fully elucidate factors contributing to these differences in order to facilitate increased smoking cessation rates among all adolescents.

Tobacco control policy and adolescent cigarette smoking status in the United States.

INTRODUCTION: Tobacco policies that limit the sale of cigarettes to minors and restrict smoking in public places are important strategies to deter youth from accessing and consuming cigarettes. METHODS: We examined the relationship of youth cigarette smoking status to state-level youth access and clean indoor air laws, controlling for sociodemographic characteristics and cigarette price. Data were analyzed from the 2001 to 2002 U.S. Health Behavior in School-Aged Children survey, a cross-sectional survey conducted with a nationally representative sample of 13,339 students in the United States. RESULTS: Compared with students living in states with strict regulations, those living in states with no or minimal restrictions, particularly high school students, were more likely to be daily smokers. These effects were somewhat reduced when logistic regressions were adjusted for sociodemographic characteristics and cigarette price, suggesting that higher cigarette prices may discourage youth to access and consume cigarettes independent of other tobacco control measures. DISCUSSION: Strict tobacco control legislation could decrease the potential of youth experimenting with cigarettes or becoming daily smokers. The findings are consistent with the hypothesis that smoking policies, particularly clean indoor air provisions, reduce smoking prevalence among high school students.

Smokers' response to combination bupropion, nicotine patch, and counseling treatment by race/ethnicity.

BACKGROUND: Evidence on how to tailor nicotine dependence treatment to specific race/ethnic groups is limited. The present study investigated responses to established smoking cessation treatments among African American, Hispanic, and White adults. METHODS: Participants were 559 smokers (126 African American, 73 Hispanic, and 360 White). All received treatment for eight weeks with open-label bupropion, the nicotine patch, and individual counseling. The dependent variable was tobacco abstinence during the last four weeks of treatment. The independent variables were race/ethnicity and other known predictors of abstinence, including sex, age, smoking history (nicotine dependence level, number of cigarettes smoked daily, serum cotinine level and expired carbon monoxide, number of past quit attempts, and age when daily smoking began), confidence in ability to stop smoking, body mass index, psychological status, and psychiatric history (past major depression and alcohol dependence). RESULTS: The total proportion of abstainers in the sample was 53%, with proportional differences by race/ethnicity (Whites 60%, African Americans 38%, Hispanics 41%). Compared to Whites, the odds ratios (OR) for quitting, adjusted for moderators of race/ ethnicity and other predictors of abstinence, were significantly lower among African Americans (OR .44, 95% confidence interval 195% CI] .27-.72) and Hispanics (OR .46, 95% CI .26-.81). CONCLUSION: Disparity in smoking cessation treatment outcome among African American and Hispanic smokers compared to Whites implies that the burden of tobacco-related illness will continue to fall disproportionately among minority racial/ethnic groups. Gaining knowledge on the effectiveness of nicotine dependence treatments and on the factors that facilitate or impede a successful response by minority smokers is a public health priority.

Translation of an evidence-based tailored childhood injury prevention program.

This article describes the process of translating Safe n' Sound, a computer-based program for parents of young children, for a general clinic environment. Safe n' Sound is designed to reduce the risk of unintentional childhood injuries, the leading cause of death among children older than 1 year in the United States. The evidence-based program produces tailored information for parents and their healthcare provider about burns, falls, poisoning, drowning, suffocations, choking prevention, and car safety. To offer Safe n' Sound to a broader audience, we translated the program from the form used for efficacy testing to a stand-alone application. Notable steps in this translation included (1) conducting an organizational assessment to determine the needs of the clinic staff and feasibility of implementation, (2) modifying the program to reduce length, prioritize risk areas, and update content, (3) repackaging the program to minimize cost and space requirements, and (4) developing promotional and instructional materials. Factors contributing to the success of this effort include strong collaborative partnerships, the relative advantage of Safe n' Sound over traditional materials, the modifiable design of the program, and the support of the clinic staff and providers. Challenges and areas for future work are discussed.

Association between psychiatric disorders and smoking stages within a representative clinic sample of Puerto Rican adolescents.

OBJECTIVE: We examined the prevalence of smoking behaviors and their association with specific psychiatric disorders in a representative sample of youth from behavioral health clinics in Puerto Rico. METHOD: A complex sampling design was used to select the sample, and analyses were conducted to account for the unequal selection probability, stratification, and clustering. All analyses were weighted back to the clinical population from which they were drawn. Psychiatric and substance use disorders were assessed using the parent and youth versions of the Diagnostic Interview Schedule for Children, Version 4.0. RESULTS: More than one third of the sample reported experience with cigarette smoking, and approximately one quarter reported smoking at least once per week (23.4%). As expected, the alcohol and drug use disorders demonstrated some of the strongest associations with individual smoking stages. These were the only disorders that remained significantly associated with nicotine dependence after controlling for comorbidity. CONCLUSIONS: Our findings confirm the need for screening of smoking behavior and nicotine dependence in treatment settings and the integration of psychiatric/substance use treatments with smoking cessation.