Trust In Medical Research Research Articles

Factors related to willingness to participate in AD biomarker studies that disclose personal results

AbstractBackgroundWith improved temporal identification and characterization of AD biomarkers, disclosure of personal biomarker information will become increasingly relevant. Understanding participant factors related to willingness to learn such information may inform relationship‐building with communities, especially those historically excluded from biomedical research, and aid the development of guidelines for safe, effective disclosure.MethodWe developed a 30‐minute phone survey to gather information from Black and W participants on willingness to enroll in different types of biomarker disclosure studies (general AD biomarker, PET, CSF, and blood‐based), reasons for enrolling, and potential outcomes following a hypothetical positive result. Data were collected from cognitively healthy participants (n=334, mean age=64.8±7.7, 45% Black) enrolled in the Wisconsin ADRC or Wisconsin Registry for Alzheimer’s Prevention. Using linear regression, we assessed the relationship between willingness to enroll in various hypothetical AD biomarker disclosure studies and age, sex, race, education, family dementia history, trust in medical research, concern about developing AD, and experiences of discrimination.ResultTrust in medical research and race were significant predictors of willingness to enroll in all the hypothetical AD biomarker disclosure studies, with higher willingness associated with greater trust in research and with White racial identification. We did not find a significant difference in trust in medical research between Black and White participants (t(df)=‐1.42(299.13), p.14). In secondary analyses, we included covariate interactions with race to assess racial differences in their effects. We found that the gender gap for Black participants in willingness to enroll in an AD CSF disclosure study was larger than that for White participants, but other effects were nonsignificant.ConclusionThese results suggest that trust in medical research is related to willingness to enroll in AD biomarker studies that disclose results to participants. As race is a social construct representing a combination of ancestry and experience, we plan to further explore the relationship between study enrollment willingness and race through a mixed‐methods approach examining quantitative and qualitative data. Understanding factors related to participant enrollment willingness may be crucial for developing culturally informed best practices for personal biomarker disclosure and in engaging and bolstering representation from historically minoritized groups into AD biomarker research.

Tailoring recruitment message content to reach diverse communities for AD research participation

AbstractBackgroundCOVID19 forced cessation of in‐person recruitment accelerating reliance on social media and other communication strategies. New strategies are needed to reach healthy controls who are typically recruited outside of clinical settings. Engaging diverse communities is also a priority given the disproportionate burden of AD and related dementias. Understanding the general and differential appeal of recruitment messaging to diverse groups will facilitate more effectively tailored messaging.MethodsThe Voices Heard Survey designed to identify factors associated with willingness to participate in biomedical research requesting biospecimens was administered to a diverse sample of 406 Wisconsin residents. Respondents include White (n=100), African American (n=105), Latino (n=100) and American Indian (n=101) adults. The 96 item survey assessed trust in medical research, along the continuum of study complexity and invasiveness relevant to AD studies, factors positively or negatively affecting willingness to participate in biomedical studies and clinical trials. Response frequencies indicated likelihood of participation were calculated for the full sample and by racial/ethnic group. Chi‐Square analyses were computed to determine significant differences across groups.ResultsSample characteristics are presented in Table 1. The factors most highly associated with willingness to volunteer for a study for the total sample were: Invited to Participate (85%), Research Goal (83%), Family Member with Disease (74%) and factors less likely to promote participation were: Share Results (48%), Paid for Participation (35%) and Transportation (34%) (see Figure 1). Significant differences were observed between the White and minority groups for the following factors: Black, Latino and American Indian respondents were: Significantly more likely to volunteer if asked by a a person of the same race (p<.0001), and more concerned than Whites about Disruption of work and family responsibilities (p< .001),Availability of transportation(p<.01), and If the results are used to help others (p<.01), and Childcare (p<.02). Remuneration for participation (p<.06) and sharing results with community (p<.07) approached significance. Specific priorities by racial and ethnic group will be presented.ConclusionAD study recruitment requires strategic communication and innovative methods of reaching groups traditionally underrepresented in biomedical research. We identified information opportunities for tailored messaging designed to increase awareness of the value and opportunities afforded of research participation.

Telephone survey to identify factors predicting willingness to enroll in biomarker studies and disclosure‐related outcomes

AbstractBackgroundAlzheimer’s disease (AD) diagnostics is evolving rapidly, moving toward biomarker‐based diagnoses characterized by amyloid, tau, and neurodegeneration. To clarify benefits and risks of using this framework with cognitively unimpaired adults, particularly those from groups under‐represented in AD biomarker research, we developed a 30‐minute telephone survey to identify factors predicting willingness to enroll in biomarker studies and hypothetical disclosure‐related outcomes.MethodExisting scales were modified for telephone administration to assess experience/concern about AD, perceived health, health locus of control, brain health social norms, trust in medical research, and experiences of discrimination. Five hypothetical scenarios assessed willingness to participate in biomarker studies with or without results disclosure. Three open‐ended items provided qualitative data on willingness to participate and share results with others. Forty‐one items assessed reasons for learning results and potential reactions following a hypothetical elevated result. Descriptive statistics were used to evaluate response patterns. Thematic analysis of open‐ended items was conducted using an inductive coding method.ResultCognitively unimpaired participants (N=334) included 148 Black/African Americans and 186 non‐Hispanic Whites; aged 45‐89; Table 1). Most participants had cared for someone with dementia (73%), desired to know if they will develop AD (82%) and trust medical research (mean RAQ‐7 = 30/35) (Table 2). Approximately 50% were very or extremely willing to participate in biomarker studies regardless of results disclosure; however, African Americans were less willing to participate if results were not disclosed. Common themes related to willingness to participate and learn results included wanting to know if at personal risk or to prevent/plan for AD and wanting to support science or help others. Misgivings/anxiety about knowing biomarker and concerns about invasiveness or lack of a cure for AD were common themes for those less willing (Table 3).ConclusionThis survey assesses AD‐relevant, health, and experiential factors, willingness to participate in biomarker research, and disclosure‐related outcomes. Initial results suggest understanding risk, prevention/planning behaviors, and helping others are reasons for participating and learning biomarker results. Results may also inform recruitment of African Americans into biomarker studies. Future analyses will investigate factors predicting potential positive (e.g., planning, risk‐reducing behavior) and negative (psychological distress/stigma) disclosure outcomes.

Use of Community Listening Sessions to Disseminate Research Findings to Past Participants and Communities.

The purpose of this sequential, explanatory mixed methods study is to determine changes in attitudes towards research, trust in medical researchers and the process, and willingness to participate in research among African Americans immediately after receiving past study findings in a community listening session (CLS). We developed and implemented four CLSs with a total of 57 African Americans who were either past research participants or members of the community-at-large. In the quantitative (dominant) phase, 32 participants completed pre-post surveys and 10 of those participants completed the follow-up semi-structured interviews. Paired samples t-tests and McNemar’s test determined bivariate differences between pre- and post-surveys. Thematic analyses determined emerging themes to further understand these differences. There was a significant increase in: (1) perceived advantages of clinical trials pretest (M = 26.63, SD = 5.43) and post-test (M = 28.53, SD = 4.24, p < .01); and (2) in trust in medical researchers from pre to post (M = 36.16, SD = 10.40 vs. M = 27.53, SD = 9.37, p < 0.001). There was no significant difference in pre- and post-tests as it relates to perceived disadvantages of clinical trials and willingness to participate. Qualitative analysis yielded the following themes: (1) sharing research results and the impact on attitudes towards research; (2) community listening sessions: a trust building strategy; and (3) satisfaction with the community listening session. Community listening sessions hold promise as a method that researchers can use to simultaneously disseminate research findings and positively impact research perceptions and potentially participation among racial and ethnic minorities.

Development and Validation of a Brief Version of the Research Engagement Survey Tool.

The Research Engagement Survey Tool (REST) examines the level of partner engagement in research studies. This study used mixed methods, including web-based surveys (N = 336), a modified Delphi process (N = 18), and cognitive response interviews (N = 16), with convenience sampling to develop and validate a short version of the REST. We conducted factor analysis and calculated internal consistency for the condensed REST. We validated the condensed REST against the comprehensive REST. All analyses were carried out on two scales (quality and quantity) based on Likert-type response options. We examined convergent validity with other measures theoretically associated with the REST (e.g., the Community Engagement Research Index and the Partnership Self-Assessment Tool). This study produced a 9-item condensed version of the REST. The condensed REST loads on 1 factor, has high internal consistency (Cronbach’s alpha = 0.92 for the quantity scale; 0.94 for the quality scale), is significantly correlated (ρ = 0.97; p < 0.001 for both scales) with the comprehensive (32-item) REST, and has negligible, low, and moderate correlation with other measures (e.g., the Partnership Assessment In community-based Research, trust in medical researchers, and the Coalition Self-Assessment Survey). Use of the condensed REST will reduce participant burden and time to complete. This standardized and validated quantitative measure is useful to compare engagement across projects or within a project over time.

Using increased trust in medical researchers to increase minority recruitment: The RECRUIT cluster randomized clinical trial

While extensive literature exists on barriers and strategies to increase minority participation in clinical trials, progress is limited. Few strategies were evaluated in randomized trials. We studied the impact of RECRUIT, a trust-based, cluster randomized minority recruitment trial layered on top of four traditional NIH-funded parent trials (BMT CTN, CABANA, PACES, STEADY-PD III; fifty specialty sites).RECRUIT was conducted from July 2013 through April 2017. Intervention sites implemented trust-based approaches customized to individual sites, promoting relationships between physician-investigators and minority-serving physicians and their minority patients. Control sites implemented only parent trials' recruitment procedures. Adjusting for within-site clustering, we detected no overall intervention effect, odds ratio 1.3 (95% confidence limits 0.7,2.4). Heterogeneity among parent trials may have obscured the effect. Of the four parent trials, three enrolled more minorities in intervention versus control sites. CABANA odds ratio = 4.2 (adjusted 95%CL 1.5,11.3). PACES intervention sites enrolled 63% (10/16) minorities; control sites enrolled one participant in total, a minority, yielding an incalculable odds ratio. STEADY-PD III odds ratio = 2.2 (adjusted 95%CL 0.6,8.5). BMT CTN odds ratio < 1, 0.8 (adjusted 95%CL 0.4,1.8).In conclusion, RECRUIT findings suggest the unique trust-based intervention increased minority recruitment to intervention trials in ¾ of studied trials. Physician-investigators' participation was critical to recruitment success. Lack of commitment to minority recruitment remained a barrier for some physician-investigators, especially in control sites. We recommend prospective physician investigators commit to minority recruitment activities prior to selection as site investigators and trial funding include some compensation for minority recruitment efforts.TRIAL REGISTRATIONClinicalTrials.govNCT01911208

A Novel Cloud-Assisted Secure Deep Feature Classification Framework for Cancer Histopathology Images

The advancements in the Internet of Things (IoT) and cloud services have enabled the availability of smart e-healthcare services in a distant and distributed environment. However, this has also raised major privacy and efficiency concerns that need to be addressed. While sharing clinical data across the cloud that often consists of sensitive patient-related information, privacy is a major challenge. Adequate protection of patients’ privacy helps to increase public trust in medical research. Additionally, DL-based models are complex, and in a cloud-based approach, efficient data processing in such models is complicated. To address these challenges, we propose an efficient and secure cancer diagnostic framework for histopathological image classification by utilizing both differential privacy and secure multi-party computation. For efficient computation, instead of performing the whole operation on the cloud, we decouple the layers into two modules: one for feature extraction using the VGGNet module at the user side and the remaining layers for private prediction over the cloud. The efficacy of the framework is validated on two datasets composed of histopathological images of the canine mammary tumor and human breast cancer. The application of differential privacy preserving to the proposed model makes the model secure and capable of preserving the privacy of sensitive data from any adversary, without significantly compromising the model accuracy. Extensive experiments show that the proposed model efficiently achieves the trade-off between privacy and model performance.

A pilot study of a culturally-appropriate, educational intervention to increase participation in cancer clinical trials among African Americans and Latinos.

Culturally-appropriate, educational programs are recommended to improve cancer clinical trial participation among African Americans and Latinos. This study investigated the effect of a culturally-appropriate, educational program on knowledge, trust in medical researchers, and intent for clinical trial participation among African Americans and Latinos in Middle Tennessee. Trained community health educators delivered a 30-min presentation with video testimonials to 198 participants in 13 town halls. A pre-post survey design was used to evaluate the intervention among 102 participants who completed both pre- and post-surveys one to two weeks after the session. Paired-sample t-test showed significant increases in unadjusted mean scores for knowledge (p < 0.001), trust in medical researchers (p < 0.001), and willingness to participate in clinical trials (p = 0.003) after the town halls in the overall sample. After adjusting for gender and education, all three outcomes remained significant for the overall sample (knowledge: p < 0.001; trust in medical researchers: p < 0.001; willingness: p = 0.001) and for African Americans (knowledge: p < 0.001; trust in medical researchers: p = 0.007; willingness: p = 0.005). However, willingness to participate was no longer significant for Latinos (knowledge: p < 0.001; trust in medical researchers: p = 0.034; willingness: p = 0.084). The culturally-appropriate, educational program showed promising results for short-term, clinical trial outcomes. Further studies should examine efficacy to improve research participation outcomes.

The use of personal health information outside the circle of care: consent preferences of patients from an academic health care institution

BackgroundImmense volumes of personal health information (PHI) are required to realize the anticipated benefits of artificial intelligence in clinical medicine. To maintain public trust in medical research, consent policies must evolve to reflect contemporary patient preferences.MethodsPatients were invited to complete a 27-item survey focusing on: (a) broad versus specific consent; (b) opt-in versus opt-out approaches; (c) comfort level sharing with different recipients; (d) attitudes towards commercialization; and (e) options to track PHI use and study results.Results222 participants were included in the analysis; 83% were comfortable sharing PHI with researchers at their own hospital, although younger patients (≤ 49 years) were more uncomfortable than older patients (50 + years; 13% versus 2% uncomfortable, p < 0.05). While 56% of patients preferred broad consent, 38% preferred specific consent; 6% preferred not sharing at all. The majority of patients (63%) preferred to be asked for permission before entry into a contact pool. Again, this trend was more pronounced for younger patients (≤ 49 years: 76%). Approximately half of patients were uncomfortable sharing PHI with commercial enterprises (51% uncomfortable, 27% comfortable, 22% neutral). Most patients preferred to track PHI usage (61%), with the highest proportion once again reported by the youngest patients (≤ 49 years: 71%). A majority of patients also wished to be notified regarding study results (70%).ConclusionsWhile most patients were willing to share their PHI with researchers within their own institution, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more specific consent options. Modernizing consent policies to reflect increased autonomy is crucial in fostering sustained public engagement with medical research.

Parental Factors Associated With the Decision to Participate in a Neonatal Clinical Trial

It remains poorly understood how parents decide whether to enroll a child in a neonatal clinical trial. This is particularly true for parents from racial or ethnic minority populations. Understanding factors associated with enrollment decisions may improve recruitment processes for families, increase enrollment rates, and decrease disparities in research participation. To assess differences in parental factors between parents who enrolled their infant and those who declined enrollment for a neonatal randomized clinical trial. This survey study conducted from July 2017 to October 2019 in 12 US level 3 and 4 neonatal intensive care units included parents of infants who enrolled in the High-dose Erythropoietin for Asphyxia and Encephalopathy (HEAL) trial or who were eligible but declined enrollment. Data were analyzed October 2019 through July 2020. Parental choice of enrollment in neonatal clinical trial. Percentages and odds ratios (ORs) of parent participation as categorized by demographic characteristics, self-assessment of child's medical condition, study comprehension, and trust in medical researchers. Survey questions were based on the hypothesis that parents who enrolled their infant in HEAL differ from those who declined enrollment across 4 categories: (1) infant characteristics and parental demographic characteristics, (2) perception of infant's illness, (3) study comprehension, and (4) trust in clinicians and researchers. Of a total 387 eligible parents, 269 (69.5%) completed the survey and were included in analysis. This included 183 of 242 (75.6%) of HEAL-enrolled and 86 of 145 (59.3%) of HEAL-declined parents. Parents who enrolled their infant had lower rates of Medicaid participation (74 [41.1%] vs 47 [55.3%]; P = .04) and higher rates of annual income greater than $55 000 (94 [52.8%] vs 30 [37.5%]; P = .03) compared with those who declined. Black parents had lower enrollment rates compared with White parents (OR, 0.35; 95% CI, 0.17-0.73). Parents who reported their infant's medical condition as more serious had higher enrollment rates (OR, 5.7; 95% CI, 2.0-16.3). Parents who enrolled their infant reported higher trust in medical researchers compared with parents who declined (mean [SD] difference, 5.3 [0.3-10.3]). There was no association between study comprehension and enrollment. In this study, the following factors were associated with neonatal clinical trial enrollment: demographic characteristics (ie, race/ethnicity, Medicaid status, and reported income), perception of illness, and trust in medical researchers. Future work to confirm these findings and explore the reasons behind them may lead to strategies for better engaging underrepresented groups in neonatal clinical research to reduce enrollment disparities.

Perceived facilitators and barriers to continued enrollment in longitudinal studies of Alzheimer disease

AbstractBackgroundRetention of study participants is critical to the success of longitudinal studies of Alzheimer Disease (AD). A comprehensive understanding of the factors that influence retention requires knowledge of what motivates study participants to continue to participate and of the perceived challenges of participation. We conducted a survey of current participants in Alzheimer Disease Centers (ADCs) to characterize their perceived facilitators and burdens of participating in longitudinal studies of AD.MethodA 57‐item interview battery with 2 open ended questions was administered by telephone to 443 randomly selected study participants from four NIA funded ADCs. Respondents were 59% female, mean age was 73±8.5 ( 49‐95 yrs), and the mean number of years enrolled was 5.1±3.5 ( 0‐13.5 yrs).ResultSurvey respondents showed strong altruistic motivation for participation. Almost all respondents (&gt;90%) indicated they were motivated by a desire to advance AD research, to benefit society, and to benefit future generations of their families. In contrast, 5% of respondents identified money or gift cards as the reason they participate. Only a small minority of respondents registered complaints about study participation. The most common problems involved fatigue (12%) and the distance/inconvenience of travel to the study visit (11%). These response patterns were broadly consistent across gender, race, and age cohorts. Women and younger respondents were slightly more altruistic in motivation than men and older respondents. Also, African American respondents were more strongly motivated by personal benefit from the study and expressed greater concern about privacy of their personal information than other respondents. They also had lower trust in medical research.ConclusionRetention of participants and their consistent attendance at regular visits is vital to the quality of longitudinal studies of AD. Our results indicate that, while most participants surveyed indicate an altruistic commitment to the study of AD, the organization of study visits could be improved to facilitate participation. In particular, increasing the convenience of both attending and executing the study visit would address the most common complaints. Furthermore, the retention of African Americans requires sensitivity to their relatively low trust in medical research.

Reducing bias and improving transparency in medical research: a critical overview of the problems, progress and suggested next steps.

In recent years there has been increasing awareness of problems that have undermined trust in medical research. This review outlines some of the most important issues including research culture, reporting biases, and statistical and methodological issues. It examines measures that have been instituted to address these problems and explores the success and limitations of these measures. The paper concludes by proposing three achievable actions which could be implemented to deliver significantly improved transparency and mitigation of bias. These measures are as follows: (1) mandatory registration of interests by those involved in research; (2) that journals support the ‘registered reports’ publication format; and (3) that comprehensive study documentation for all publicly funded research be made available on a World Health Organization research repository. We suggest that achieving such measures requires a broad-based campaign which mobilises public opinion. We invite readers to feedback on the proposed actions and to join us in calling for their implementation.

The Association between Emergency Department Super-Utilizer Status and Willingness to Participate in Research.

Background Research based on emergency departments (EDs) primarily focuses on medical conditions. There is limited research that investigates patients who willingly participate in research. This current study explored ED super-utilizers' (SUs') and nonsuper-utilizers' (NSUs') attitudes toward research. Objective The study assesses the willingness of SUs to participate in research. We hypothesize that the SU population will be as interested as nonutilizers in participating in medical research. Methods This prospective observational study stratified participants into SU and NSU cohorts based on their self-reported number of ED visits within 6 months. Surveys were captured in a secured database and analyzed using SAS 9.4. Results 7,481 completed questionnaires. SUs were more interested in participating in all types of research compared to NSUs. Both groups were most willing to participate in surveys. Neither group was particularly interested in studies that required medications. SUs were not more willing to participate in studies without payment than NSUs. Both groups trusted researchers at the same rates. Conclusion Although rarely included in medical research, SUs were more willing to participate in nearly all types of research and expressed a similar trust in medical research when compared to nonsuper-utilizers.

Engagement of community stakeholders to develop a framework to guide research dissemination to communities.

BackgroundDissemination of research findings to past study participants and the community‐at‐large is important. Yet, a standardized process for research dissemination is needed to report results to the community.ObjectiveWe developed a framework and strategies to guide community‐academic partnerships in community‐targeted, dissemination efforts.MethodsFrom 2017 to 2019, a community‐academic partnership was formed in Nashville, Tennessee, and iteratively developed a framework and strategies for research dissemination using cognitive interviews. A deductive, constant comparative analysis was conducted on interview responses to examine framework and strategy content. Feedback was used to finalize the framework and strategies for the evaluation. Using existing data, the framework's utility was evaluated in seven town hall meetings (n = 117). Bivariate analyses determined its effect on community members’ trust and willingness to participate in research using pre‐ and post‐surveys. Evaluation results were used to finalize the framework.ResultsThe Community‐Engaged Research Dissemination (CERD) framework has two phases. Phase one is a preliminary planning phase with two steps, and phase two is the four‐step dissemination process. There are five standards to be upheld conducting these phases. We provide competencies for each component. Three feasible, culturally adapted strategies were developed as exemplars to disseminate research findings. Using pre‐ and post‐surveys for intervention evaluation, there was a significant difference in trust in medical research and researchers (P = .006) and willingness to participate in research (P = .013).Discussion and ConclusionThe CERD framework can potentially standardize the process and compare the effect of dissemination efforts on the community's trust and willingness to participate in research.

The use of patient health information outside the circle of care: Consent preferences of patients from a large academic cancer centre.

e14122 Background: Massive volumes of patient health information (PHI) are required to realize the anticipated benefits of artificial intelligence in future clinical medicine. To maintain public trust in medical research however, consent policies must evolve to reflect contemporary patient preferences. Methods: From January-December 2019, patients attending clinics at a large academic cancer centre were invited to complete a 27-item iPad survey on consent preferences. Survey items focused on: (a) broad vs. specific consent; (b) opt-in vs. opt-out approaches for research contact; (c) comfort sharing with different recipients; (d) perceptions on commercialization; and (e) options to track information use and study results. Demographic questions addressed cancer type, treatment stage, age, gender, ethnicity, education level, and household income. Results: A total of 222 participants were included in the analysis (112 males, 108 females; 2 rather not say); 83% were comfortable sharing PHI with researchers at their own hospital. While 56% of patients preferred broad consent, 38% preferred to be contacted with study details and asked to consent every time (specific consent); 6% prefer not to share at all. Younger patients ( &lt; 49 years) most often chose specific consent (50%); significantly more than those 75+ years (24%; p &lt; .05). Younger patients ( &lt; 49 years) were also significantly more uncomfortable than older patients (50+ years) sharing even within their own hospital (13% uncomfortable vs. 1% uncomfortable; p &lt; .05). A significant majority of patients (63%, p = .0001) preferred to be asked for permission before being entered into a contact pool vs. automatic entry with opportunity to opt-out. The majority of patients were uncomfortable sharing PHI with commercial enterprises (51% uncomfortable, 27% comfortable, 22% neutral). A significant majority expressed the desire to track who is using their PHI (61%, p &lt; .0001), and be notified regarding study results (70%, p &lt; .0001). Conclusions: While most patients were willing to share their PHI with researchers at their own hospital, many preferred a transparent and reciprocal consent process. These data also suggest a generational shift, wherein younger patients preferred more informed consent options. Modernizing consent policies to reflect increased patient interest in the exercise of their autonomy is crucial in fostering sustained public engagement in medical research.

Negative association of perceived risk and willingness to participate in innovative psychiatric research protocols

Psychiatric researchers grapple with concerns that individuals with mental illness may be less likely to appreciate risks of research participation, particularly compared to people not suffering from mental illness. Therefore, empirical studies that directly compare the perspectives of such individuals are needed. In addition, it is important to evaluate perspectives regarding varied types of research protocols, particularly as innovative psychiatric research protocols emerge. In this pilot study, respondents with a mood disorder (n = 25) as well as respondents without a mood disorder (n = 55) were recruited using Amazon's Mechanical Turk (MTurk) platform. These respondents were surveyed regarding four psychiatric research projects (i.e., experimental medication [pill form]; non-invasive magnetic brain stimulation; experimental medication [intravenous infusion]; and implantation of a device in the brain). Regardless of health status, respondents rated the four research protocols as somewhat to highly risky. The brain-device implant protocol was seen as the most risky, while the magnetic brain stimulation project was viewed as “somewhat risky”. Respondents, on average and regardless of health status, rated their willingness at or below “somewhat willing.” Respondents were least willing to participate in the brain-device implant protocol, whereas they were “somewhat willing” to participate in the magnetic brain stimulation protocol. Trust in medical research was negatively associated with perceived risk of research protocols. Perceived risk was negatively associated with willingness to participate, even when adjusting for potential confounders, suggesting that attunement to risk crosses diagnostic, gender, and ethnic categories, and is more salient to research decision-making than trust in medical research and dispositional optimism. The findings of this study may offer reassurance about the underlying decision-making processes of individuals considering participation in innovative neuroscience studies.

Measuring Trust in Medical Researchers: Adding Insights from Cognitive Interviews to Examine Agree-Disagree and Construct-Specific Survey Questions.

While scales measuring subjective constructs historically rely on agree-disagree (AD) questions, recent research demonstrates that construct-specific (CS) questions clarify underlying response dimensions that AD questions leave implicit and CS questions often yield higher measures of data quality. Given acknowledged issues with AD questions and certain established advantages of CS items, the evidence for the superiority of CS questions is more mixed than one might expect. We build on previous investigations by using cognitive interviewing to deepen understanding of AD and CS response processing and potential sources of measurement error. We randomized 64 participants to receive an AD or CS version of a scale measuring trust in medical researchers. We examine several indicators of data quality and cognitive response processing including: reliability, concurrent validity, recency, response latencies, and indicators of response processing difficulties (e.g., uncodable answers). Overall, results indicate reliability is higher for the AD scale, neither scale is more valid, and the CS scale is more susceptible to recency effects for certain questions. Results for response latencies and behavioral indicators provide evidence that the CS questions promote deeper processing. Qualitative analysis reveals five sources of difficulties with response processing that shed light on under-examined reasons why AD and CS questions can produce different results, with CS not always yielding higher measures of data quality than AD.

Does an interactive trust-enhanced electronic consent improve patient experiences when asked to share their health records for research? A randomized trial.

In the context of patient broad consent for future research uses of their identifiable health record data, we compare the effectiveness of interactive trust-enhanced e-consent, interactive-only e-consent, and standard e-consent (no interactivity, no trust enhancement). A randomized trial was conducted involving adult participants making a scheduled primary care visit. Participants were randomized into 1 of the 3 e-consent conditions. Primary outcomes were patient-reported satisfaction with and subjective understanding of the e-consent. Secondary outcomes were objective knowledge, perceived voluntariness, trust in medical researchers, consent decision, and time spent using the application. Outcomes were assessed immediately after use of the e-consent and at 1-week follow-up. Across all conditions, participants (N = 734) reported moderate-to-high satisfaction with consent (mean 4.3 of 5) and subjective understanding (79.1 of 100). Over 94% agreed to share their health record data. No statistically significant differences in outcomes were observed between conditions. Irrespective of condition, black participants and those with lower education reported lower satisfaction, subjective understanding, knowledge, perceived voluntariness, and trust in medical researchers, as well as spent more time consenting. A large majority of patients were willing to share their identifiable health records for research, and they reported positive consent experiences. However, incorporating optional additional information and messages designed to enhance trust in the research process did not improve consent experiences. To improve poorer consent experiences of racial and ethnic minority participants and those with lower education, other novel consent technologies and processes may be valuable. (An Interactive Patient-Centered Consent for Research Using Medical Records; NCT03063268).

Factors influencing parental trust in medical researchers for child and adolescent patients’ clinical trial participation

ABSTRACTParental trust in medical researchers is a commonly cited barrier to their child’s participation in clinical research. Yet, there is little understanding of factors influencing parental trust to be implemented in interventions to address their concerns. This study seeks to identify psychosocial and modifying factors influencing parental trust in medical researchers to improve child and adolescent patients clinical trial participation, and potentially their health outcomes. We conducted a cross-sectional study with 307 parents. Multiple ordinary linear (OLS) regression was conducted to determine: (1) psychosocial and modifying factors associated with parental trust; and (2) perceived advantages and disadvantages associated with parental trust. Parent’s race (White) (β = .343, p < .001), higher education level (β = .409, p < .001), higher perceived advantages of adolescent clinical trials (β = .142, p < .001), and lower perceived disadvantages of adolescent clinical trials (β = −.337, p = .001) were the most significant predictors of higher levels of parental trust in medical researchers. Parents who were African American and had lower education levels expressed lower levels of trust in medical researchers. Education on the benefits of clinical trials could reduce parents’ apprehension towards their child’s participation in clinical trials. Results support the development of a clinical trial education program for parents to improve their trust in medical researchers.

Factors influencing the willingness to participate in medical research: a nationwide survey in Taiwan

BackgroundParticipation rate is one of the main challenges medical researchers face. We examined how demographic background and trust in medical research affect the willingness of people to participate in medical research in Taiwan.MethodsData from the 2011 Taiwan Genomic Survey (a nationwide representative face-to-face survey) were analyzed. The survey included a vignette of a researcher conducting a clinical trial of an investigative medicinal product, and questions for interviewees regarding their willingness to participate in research after they were informed of the scenario description. A total of 3,159 people, aged 18 to 70 years, were sampled, and 1,538 of them completed the survey. With missing data excluded, a total of 1,389 respondents were included in the final analysis.ResultsAbout 12 percent of the respondents answered that they would be willing to participate in medical research. Respondents who had college degrees or above and were married or lived with significant others were less likely to participate in medical research. By contrast, male respondents, and respondents whose household family members had biomedicine-related degrees or had one themselves were more likely to participate in medical research. After adjustment for demographic factors, respondents were more likely to participate in medical research if: (1) they expressed trust in doctors conducting medical research; (2) they agreed that doctors would never ask them to join medical research studies that might harm them; (3) they thought that participating in a medical research study would be safe; and (4) they agreed that researchers had no selfish reasons for doing the medical research.DiscussionSome of our findings, such as the effects of education level and marital status on participation in medical research, are different from most findings of previous studies conducted in other countries. This study is useful for developing strategies to improve participant recruitment. Relevant discussions on research ethics and policies, such as the importance of public trust in medical researchers, could also be based on this study.