Hypothetical and factual willingness to participate in biobank research

In the debate on biobank regulation, arguments often draw upon findings in surveys on public attitudes. However, surveys on willingness to participate in research may not always predict actual participation rates. We compared hypothetical willingness as estimated in 11 surveys conducted in Sweden, Iceland, United Kingdom, Ireland, United States and Singapore to factual participation rates in 12 biobank studies. Studies were matched by country and approximate time frame. Of 22 pairwise comparisons, 12 suggest that factual willingness to participate in biobank research is greater than hypothetical, six indicate the converse relationship, and four are inconclusive. Factual donors, in particular when recruited in health care or otherwise face-to-face with the researcher, are possibly motivated by factors that are less influential in a hypothetical context, such as altruism, trust, and sense of duty. The value of surveys in assessing factual willingness may thus be limited.     

Knowledge about vaccine trials and willingness to participate in an HIV/AIDS vaccine study in the Ugandan military

The HIV-1 infections detected in an ongoing national unlinked anonymous HIV surveillance program were subtyped and analyzed according to demographic and risk characteristics. Of the 893 anti--HIV-1--positive specimens allocated to an exposure group, 70% could be subtyped. Almost 25% of infections subtyped were non-B, mostly subtypes A, C, and D. Non-B infections were rare in homosexual and bisexual men and in drug injectors. Forty percent of infections in heterosexual men attending genitourinary medicine clinics were non-B subtypes; of these, 25% were subtype A infections and 59% were subtype C infections. For female clinic attendees, 61% were non-B subtype infections, of which 48% were subtype A infections and 42% were subtype C infections. Of the clinic attendees born in the United Kingdom and Europe, 14% of the men and 35% of the women were infected with non-B subtypes. In contrast, 78% of infections in antenatal patients were non-B subtypes, of which 61% were subtype A and 29% were subtype C. Extrapolation to the estimated 29,700 prevalent adult infections in the United Kingdom indicates that approximately 8,100 (27%) such infections are non-B subtypes and that these are found almost entirely in heterosexuals. The findings suggest spread of infection of non-B subtypes to heterosexuals born in the United Kingdom from individuals infected in regions of high prevalence.     

Knowledge about vaccines and willingness to participate in preventive HIV vaccine trials: a population-based study, Rakai, Uganda

The purpose of the study was to assess knowledge and beliefs regarding vaccines and willingness to participate in HIV vaccine trials. A baseline survey assessed knowledge and attitudes toward vaccination and potential HIV vaccines among 14,177 participants aged 15-49 years, in a population cohort. Willingness to participate in HIV-preventive vaccine trials was assessed during a follow-up survey 10 months later after providing community education on HIV vaccines. Knowledge of the preventive utility of vaccines was high (71%), but higher in men than women (P<0.001), and increased with education levels (P<0.001). Vaccines were considered appropriate for children and women (99 and 88%, respectively), but not for adult men (28%). Participants felt that adolescents were the most appropriate subjects for HIV preventive vaccine trials (93.7%) but also thought that HIV-positive persons were eligible for trials (60.2%), and only 20% thought a preventive vaccine could help control HIV. HIV vaccine awareness increased from 68% at baseline to 81% at follow-up (P<0.001). Willingness to participate in HIV-preventive vaccine trials was 77%. Vaccine knowledge and willingness to participate in trials are high in this population. However, there still is need for education on the potential role of preventive HIV vaccines in the control of the epidemic and the importance of vaccination for men, especially in the context of an HIV vaccine.     

Patient ability and willingness to participate in a web-based intervention to improve hypertension control

Background

Patient-shared electronic health records provide opportunities for care outside of office visits. However, those who might benefit may be unable to or choose not to use these resources, while others might not need them.

Objective

Electronic Communications and Home Blood Pressure Monitoring (e-BP) was a randomized trial that demonstrated that Web-based pharmacist care led to improved blood pressure (BP) control. During recruitment we attempted to contact all patients with hypertension from 10 clinics to determine whether they were eligible and willing to participate. We wanted to know whether particular subgroups, particularly those from vulnerable populations, were less willing to participate or unable to because they lacked computer access.

Methods

From 2005 to 2006, we sent invitation letters to and attempted to recruit 9298 patients with hypertension. Eligibility to participate in the trial included access to a computer and the Internet, an email address, and uncontrolled BP (BP ≥ 140/90 mmHg). Generalized linear models within a modified Poisson regression framework were used to estimate the relative risk (RR) of ineligibility due to lack of computer access and of having uncontrolled BP.

Results

We were able to contact 95.1% (8840/9298) of patients. Those refusing participation (3032/8840, 34.3%) were significantly more likely (P < .05) to be female, be nonwhite, have lower levels of education, and have Medicaid insurance. Among patients who answered survey questions, 22.8% (1673/7354) did not have computer access. Older age, minority race, and lower levels of education were risk factors for lack of computer access, with education as the strongest predictor (RR 2.63, 95% CI 2.30-3.01 for those with a high school degree compared to a college education). Among hypertensive patients with computer access who were willing to participate, African American race (RR 1.22, 95% CI 1.06-1.40), male sex (RR 1.28, 95% CI 1.18-1.38), and obesity (RR 1.53, 95% CI 1.31-1.79) were risk factors for uncontrolled BP.

Conclusion

Older age, lower socioeconomic status, and lower levels of education were associated with decreased access to and willingness to participate in a Web-based intervention to improve hypertension control. Failure to ameliorate this may worsen health care disparities.

Trial Registration

Clinicaltrials.gov NCT00158639; http://www.clinicaltrials.gov/ct2/show/NCT00158639 (Archived by WebCite at http://www.webcitation.org/5v1jnHaeo)     

Primary care physicians' perceptions of barriers to genetic testing and their willingness to participate in research

Our objective was to explore the barriers and motivations to: 1) appropriate diffusion of genetic services into primary care practice; and 2) primary care physicians' (PCPs) willingness to participate in clinical studies to assess the safety and effectiveness of emerging genetic technologies. A random sample (n = 994) of PCPs was invited to be interviewed. Of the 80 who agreed, 60 were interviewed, 52 by telephone. A semi-structured guide was used. A questionnaire mailed to 752 of the PCPs was used to elicit information from physicians who did not want to be interviewed. Among interviewees, uncertainty as to the clinical utility and clinical validity of predictive genetic testing were the leading barriers to incorporation of this technology into practice, being mentioned by 60 and 43% of subjects, respectively. Of the 100 (13. 3%) physicians returning the questionnaire who declined to be interviewed, 30% said they would be willing to participate in research on the safety and effectiveness of predictive genetic tests. Of those who were interviewed, 92% were willing to participate in such research. Most physicians do not see genetics as important in their practice today; many anticipate greater importance in the future. The proportion of physicians interested in participating in research to assess the safety and effectiveness of genetic tests is sufficient to make large scale, collaborative, practice-based evaluation feasible. Additionally, participation in research may serve as an effective medium for physician education in genetics.     

Determinants of the willingness to participate in biobanking among Malaysian stakeholders in the Klang Valley

Background

The demand in biobanking for the collection and maintenance of biological specimens and personal data from civilians to improve the prevention, diagnosis and treatment of diseases has increased notably. Despite the advancement, certain issues, specifically those related to privacy and data protection, have been critically discussed. The purposes of this study are to assess the willingness of stakeholders to participate in biobanking and to determine its predictors.

Methods

A survey of 469 respondents from various stakeholder groups in the Klang Valley region of Malaysia was carried out. Based on previous research, a multi-dimensional instrument measuring willingness to participate in biobanking, and its predictors, was constructed and validated. A single step Structural Equation Modelling was performed to analyse the measurements and structural model using the International Business Machines Corporation Software Package for Social Sciences, Analysis of Moment Structures (IBM SPSS Amos) version 20 with a maximum likelihood function.

Results

Malaysian stakeholders in the Klang Valley were found to be cautious of biobanks. Although they perceived the biobanks as moderately beneficial (mean score of 4.65) and were moderately willing to participate in biobanking (mean score of 4.10), they professed moderate concern about data and specimen protection issues (mean score of 4.33). Willingness to participate in biobanking was predominantly determined by four direct predictors: specific application-linked perceptions of their benefits (β?=?0.35, p?<?0.001), issues of data and specimen protection (β?=???0.31, p?<?0.001) and religious acceptance (β?=?0.15, p?<?0.05) and trust in key players (β?=?0.20, p?<?0.001). The stakeholders’ willingness to participate in biobanking also involves the intricate relationships between the above-mentioned factors and other predictors, such as attitudes regarding technology, religiosity and engagement.

Conclusions

The findings of this study reaffirmed that stakeholders’ willingness to participate in biobanking is a complex phenomenon that should be viewed from a multidimensional perspective. Stakeholder willingness to participate in biobanking is warranted when direct predictors (benefits, issues of data and specimen protection, religious acceptance, and trust in key players) as well as indirect factors are well accounted for.

     

Guiding the vaginal microbicide trials with biomarkers of inflammation

This article discusses cytokine patterns as potential biomarkers of vaginal inflammation, which are needed for the safety evaluation of topical microbicide products for the prevention of sexually transmitted HIV-1 infection. In order to be effective, the vaginal anti-HIV-1 microbicides should avoid proinflammatory responses that facilitate transepithelial viral penetration and replication. Pro-inflammatory and anti-inflammatory cytokines play bi-directional roles in HIV-1 pathogenesis, transmission, susceptibility and resistance. Previous research has shown that many of these key mediators of mucosal barrier function (e.g. IL-1, IL-1 receptor antagonist, IL-6, TNF-alpha, TNF-receptor II, transforming growth factor beta, IL-10, IL-12, IL-8, macrophage inhibitory protein 1, etc.) can be detected in the vaginal secretions of healthy or infected individuals using non-invasive sampling techniques. As part of two microbicide trials, we measured IL-lalpha, IL-1beta, IL-1 receptor antagonist, TNF-alpha and IL-8 in 291 cervicovaginal lavage samples obtained before product use and at the seventh and 14th day after product use. We showed that vaginal formulations, temperature and matrix-specific factors in the vaginal fluids may interfere with cytokine detection, and therefore specific protocols must be validated for various collection procedures and cytokine assays. Our results suggest that combined patterns of cytokine dynamics rather than individual measurements might distinguish proinflammatory product-related effects in microbicide safety trials. More research is needed to establish cytokine mucosal baselines and modulation by genetic factors, sexual intercourse, menstrual cycle, exercise, hormones, stress and infections before guidelines can be established for clinical trial enrollment criteria, the prediction of side/adverse events and ultimately microbicide benefit prognostication.     

Knowledge of the Tuskegee study and its impact on the willingness to participate in medical research studies

The under-representation of racial/ethnic minorities among medical research participants has recently resulted in mandates for their inclusion by the National Institutes of Health (NIH). Therefore, there is a need to determine how history, attitudes, cultural beliefs, social issues, and investigator behavior affect minority enrollment in medical research studies. From January 1998 to March 1999, 179 African-American and white residents of the Detroit Primary Metropolitan Statistical Area (PMSA) participated in a mail and telephone survey designed to examine impediments to African-American participation in medical research studies. Chi-square tests were performed to assess differences between the study groups using the Survey Data Analysis Program (SUDAAN). Eighty-one percent of African Americans and 28% of whites had knowledge of the Tuskegee Study (p = <0.001). Knowledge of the Tuskegee Study resulted in less trust of researchers for 51% of African-Americans and 17% of whites (p = 0.02). Forty-six percent of African-Americans and 34% of whites indicated that their knowledge of the study would affect future research participation decisions (p = 0.25). Of these, 49% of African-Americans and 17% of whites would not be willing to participate in future medical research studies (p = 0.05). This study confirms the need for medical researchers to confront the issue of the Tuskegee Study and its continuing impact on African-Americans' trust of medical research studies.     

African Americans' responses to genetic explanations of lung cancer disparities and their willingness to participate in clinical genetics research

PurposeTo assess whether reactions to genetic explanations for disparities in lung cancer incidence among family members of African American patients with lung cancer are associated with willingness to participate in clinical genetics research.MethodsData are reported for 67 self-identified African Americans aged 18 to 55 years who completed a telephone survey assessing reactions to explanations (i.e., genetics, toxin exposure, menthol cigarettes, and race-related stress) for lung cancer disparities. Majority were female (70%), current smokers (57%), and patients' biological relatives (70%).ResultsFamily members rated the four explanations similarly, each as believable, fair, and not too worrisome. Participants also indicated a high level of willingness to participate in genetics research (M = 4.1 ± 1.0; scale: 1-5). Endorsements of genetics explanations for disparities as believable and fair, and toxin exposure as believable were associated significantly with willingness to participate in genetics research.ConclusionThese results suggest that strategies to encourage African Americans' participation in genetics research would do well to inform potential participants of how their involvement might be used to better understand important environmental factors that affect health disparities.     

Women's willingness to be tested for human immunodeficiency virus during pregnancy: A review

Mother-to-child-transmission of human immunodeficiency virus(HIV) is a primary cause of pediatric infections with HIV. Many of these infections involve women who were not tested early enough in pregnancy, or who didnot receive prevention services. HIV testing of pregnant women is considered to be one of the key strategies for preventing mother-to-child-transmission of HIV, but HIV testing rates among pregnant women in various countries remain suboptimal. Understanding the factors relating to women's willingness to be tested for HIV during pregnancy is critical for developing strategies to increase HIV testing rates among pregnant women. Extensive research points to various factors relating to women's willingness to be tested for HIV during pregnancy, and various recommendations aimed at improving testing rates among pregnant women have been suggested based on the research. In light of the goals set by the United Nations to reduce the rate of infants infected with HIV, it is necessary to summarize what is currently known regarding factors related to women's willingness to be tested for HIV during pregnancy. The purpose of this review is therefore to examine factors related to women's willingness to be tested for HIV during pregnancy, and to summarize recommendations for practice and further research.     

Willingness of injection drug users to participate in an HIV vaccine efficacy trial in Bangkok, Thailand.

We assessed willingness to participate in an HIV recombinant gp120 bivalent subtypes B/E candidate vaccine efficacy trial among 193 injection drug users (IDUs) attending drug treatment clinics in Bangkok, Thailand. IDUs previously enrolled in a prospective cohort study were invited to group sessions describing a potential trial, then completed questionnaires assessing comprehension and willingness to participate. A week later, they completed a follow-up questionnaire that again assessed comprehension and willingness to participate, as well as barriers to and positive motives for participation, with whom (if anyone) they talked about the information, and whether others thought participation was a good, bad, or neutral idea. At baseline, 51% were definitely willing to participate, and at follow-up 54%; only 3% were not willing to participate at either time. Comprehension was high at baseline and improved at follow-up. Participants who viewed altruism, regular HIV tests, and family support for participation as important were more willing to volunteer. Frequency of incarceration and concerns about the length of the trial, possible vaccine-induced accelerated disease progression, and lack of family support were negatively associated with willingness. Overall, IDUs comprehended the information needed to make a fully informed decision about participating in an rgp120 vaccine efficacy trial and expressed a high level of willingness to participate in such a trial.     

Interpretation of genital findings in microbicide safety trials: review of the 'Photo Atlas for Microbicide Evaluation'

The Photo Atlas for Microbicide Evaluation was published in May 2002 for distribution among researchers to be used as a training or reference document during microbicide clinical trials. We have reviewed the contents of the Photo Atlas, including the interpretation and documentation of genital findings. The rationale for the categorization of genital lesions into different lesion types is also discussed. Efforts will continue to standardize colposcopy until more accurate and objective methods become available to assess the safety of candidate microbicides.     

Using modeling to explore the degree to which a microbicide's sexually transmitted infection efficacy may contribute to the HIV effectiveness measured in phase 3 microbicide trials

BACKGROUND: Several microbicide candidates show activity against pathogens that cause sexually transmitted infections (STIs). This may increase a microbicide's impact on HIV in phase 3 trials. Modeling is used to estimate the degree to which a microbicide's STI efficacy contributes to the HIV effectiveness of a phase 3 microbicide trial. METHODS: An expression is derived and coupled with an STI model to estimate how much a microbicide's STI efficacy contributes to a trial's HIV effectiveness. The STI model estimates the decrease in STI prevalence that may occur in the trial's active gel arm for microbicides of different STI efficacy. Projections are produced for different STI cofactors and epidemiological settings. RESULTS: The model projects that if a microbicide is active against curable STIs with a combined prevalence of >or=10% among trial participants and the reduction in HIV incidence is <50%, then the STI activity could have substantially contributed to the trial's HIV effectiveness (>50% in some cases) if the per exposure multiplicative STI cofactor is 2.5 or greater. However, if the STI prevalence is <10% or the STI cofactor is <2.5 or if the reduction in HIV incidence is >50%, then the trial's HIV effectiveness will be mainly due to its direct HIV efficacy. CONCLUSIONS: In high STI settings, phase 3 trials documenting a moderate impact on HIV incidence may partially result from a gel's activity against curable STI. Care should be taken generalizing these trial results to other settings. This is less important for trials documenting large reductions in HIV incidence.     

Seroprevalence of Neospora caninum infection in dairy cows in Northern provinces,Thailand

Neospora caninum, an obligate intracellular protozoan parasite, is the causative agent of neosporosis, recognized as a major cause of bovine abortion around the world. Thailand is a developing agricultural country located in Southeast Asia. Livestock developments particularly in dairy cows of this country have been hampered by low productivity including milk and slow growth rate due to the impact of many pathogens including N. caninum. Currently, there is no effective method for control of neosporosis since there is less information regarding current status of infections. The objective of this study was to investigate the seroprevalence of neosporosis in dairy cows of the northern part of Thailand. During 2006–2007, the sera of 642 cows from 42 small farm holders with the top three highest consensus of dairy farms in the northern provinces, such as Chiang Rai, Chiang Mai and Lumpang were collected and performed tests. Antibodies to N. caninum were assayed by enzyme-linked immunosorbent assay (ELISA) with recombinant N. caninum surface antigen 1 (NcSAG1) and indirect fluorescent antibody test (IFAT). The overall prevalence of N. caninum infection in this study was 46.9% (301/642) by ELISA and 34.3% (220/642) by IFAT.     

Patient willingness to take teriparatide

OBJECTIVE: Teriparatide [rhPTH (1-34)] is an effective treatment for osteoporosis administered by daily subcutaneous injection. The objective of this study was to determine how much benefit women expect teriparatide to confer before agreeing to perform daily injections. METHODS: We recruited postmenopausal women who had recently undergone bone densitometry and were found to have either a T-score less than -2.5 at the hip or spine and/or had a fracture index (FI) of > or =6. Participants completed an adaptive conjoint analysis questionnaire to determine their treatment preferences. RESULTS: The study sample included 185 women, mean age 71 (range 46-90). An increasing number of subjects preferred rhPTH (1-34) as the efficacy of teriparatide increased, but most women demanded efficacy advantages greater than those demonstrated in clinical studies. We found no association between absolute fracture risk and preference for rhPTH (1-34); however, subjects with an excessively high perceived risk of future fracture were more likely to accept daily subcutaneous injections compared to subjects with a lower perceived risk of future fracture (40% versus 15%, p = 0.001). CONCLUSION: Our results suggest that most women demand benefits far greater than those conferred by rhPTH (1-34) in order to administer daily subcutaneous injections to decrease their future risk of fractures. PRACTICE IMPLICATIONS: Given the poor adherence for treatment of osteoporosis, and the choices older adults must make when paying for medications, development of novel treatment approaches should be based on older adults' treatment preferences.     

Prevention of mother-to-child transmission of HIV in Thailand: physicians' attitudes on zidovudine use, pregnancy termination, and willingness to provide care.

We administered a survey to Thai physicians, using regular mail, on their attitudes and practices regarding zidovudine (ZDV) use and pregnancy termination in HIV-infected pregnant women. We surveyed their willingness to care for these patients as well. In 1997, 79.5% of 480 respondents reported that they did not routinely use perinatal ZDV prophylaxis. Predictors of failure to use ZDV found to be significant in our logistic regression model included practice outside of Bangkok (odds ratio [OR] = 2.0), belief that ZDV is not cost effective (OR = 2.5), unfamiliarity with AIDS Clinical Trials Group (ACTG) 076 results (OR = 2.5), and failure to screen for HIV routinely (OR = 4.9). Elective abortion for HIV-infected women was advocated by 45.3% of respondents. Factors associated in multivariable analysis with this preference included specialty training in obstetrics/gynecology (OR = 1.8), practice inside Bangkok (OR = 2.0), male gender (OR = 1.9), and treatment of < or =2 HIV-infected patients yearly (OR = 1.8). A significant proportion of respondents described themselves as unwilling to perform pelvic examinations (19.2%), vaginal deliveries (30.7%), or cesarean deliveries (39.5%) on women who were known to be infected with HIV. We conclude that many Thai obstetric providers are reluctant to care for HIV-infected women, do not routinely use perinatal ZDV prophylaxis, and prefer to terminate pregnancies among HIV-infected patients. Physician education concerning the value of HIV screening and antiretroviral therapy in HIV-infected pregnant women is needed urgently in Thailand.