COVID-19 clinical trial participation and awareness in Texas.

The COVID-19 pandemic required the rapid development of COVID-19 vaccines and treatments, necessitating quick yet representative clinical trial enrollment to evaluate these preventive measures. However, misinformation around the COVID-19 pandemic and general concerns about clinical trial participation in the U.S. hindered clinical trial enrollment. This study assessed awareness of, willingness to participate in, and enrollment in COVID-19 vaccine and treatment clinical trials in Texas. A quota sample of 1,089 Texas residents was collected online from June - July 2022. Respondents were asked if they were aware of, willing to participate in, and had enrolled in clinical trials for COVID-19 vaccines or treatments. Overall, 45.8% of respondents reported being aware of clinical trials for COVID-19 treatments or vaccines, but only 21.7% knew how to enroll and only 13.2% had enrolled in a COVID-19 clinical trial. Respondents with bachelor's or graduate degrees were more likely to be aware of clinical trials, more likely to have enrolled in trials, and more willing to participate in treatment trials. Women were less willing to participate and less likely to have enrolled in COVID-19 clinical trials than men. Respondents aged 55 years and older were more willing to participate, but less likely to have enrolled in COVID-19 clinical trials than 18-to-24-year-olds. Common reasons given for not participating in clinical trials included concerns that COVID-19 treatments may not be safe, government distrust, and uncertainty about what clinical trial participation would entail. Substantial progress is needed to build community awareness and increase enrollment in clinical trials.

Mexican Americans agree to participate in longitudinal clinical research more than non-Hispanic whites.

BACKGROUND: The National Institutes of Health has advocated for improved minority participation in clinical research, including clinical trials and observational epidemiologic studies since 1993. An understanding of Mexican Americans (MAs) participation in clinical research is important for tailoring recruitment strategies and enrollment techniques for MAs. However, contemporary data on MA participation in observational clinical stroke studies are rare. We examined differences between Mexican Americans (MAs) and non-Hispanic whites (NHWs) participation in a population-based stroke study. METHODS: We included 3,594 first ever stroke patients (57.7% MAs, 48.7% women, median [IQR] age 68 [58-79]) from the Brain Attack Surveillance in Corpus Christi Project, 2009-2020 in Texas, USA, who were approached and invited to participate in a structured baseline interview. We defined participation as completing a baseline interview by patient or proxy. We used log-binomial models adjusting for prespecified potential confounders to estimate prevalence ratios (PR) of participation comparing MAs with NHWs. We tested interactions of ethnicity with age or sex to examine potential effect modification in the ethnic differences in participation. We also included an interaction between year and ethnicity to examine ethnic-specific temporal trends in participation. RESULTS: Baseline participation was 77.0% in MAs and 64.2% in NHWs (Prevalence Ratio [PR] 1.20; 95% CI, 1.14-1.25). The ethnic difference remained after multivariable adjustment (1.17; 1.12-1.23), with no evidence of significant effect modification by age or sex (Pinteraction by age = 0.68, Pinteraction by sex = 0.83). Participation increased over time for both ethnic groups (Ptrend < 0.0001), but the differences in participation between MAs and NHWs remained significantly different throughout the 11-year time period. CONCLUSION: MAs were persistently more likely to participate in a population-based stroke study in a predominantly MA community despite limited outreach efforts towards MAs during study enrollment. This finding holds hope for future research studies to be inclusive of the MA population.

Mental disorders, participation, and trajectories in the Danish colorectal cancer programme: a population-based cohort study.

BACKGROUND: People with mental disorders exhibit increased mortality due to colorectal cancer, despite having a similar incidence to the general population. We aimed to evaluate the extent to which people with mental disorders participate in organised colorectal cancer screening. METHODS: We conducted a population-based cohort study of all Danish residents aged 50-74 years who were invited to undergo biennial faecal immunochemical testing between March 1, 2014, and Sept 30, 2018. We used national registry data from all first-time invitees. The primary endpoint was participation within 90 days of invitation. We calculated the proportion who participated and assessed their screening results and adherence to and completeness of follow-up colonoscopy according to their history of mental disorders, classified as none, mild or moderate, or severe. We computed crude and adjusted participation differences in percentage points and participation ratios using the pseudo-observations method. FINDINGS: Of 2 036 704 people who were invited, we included 2 036 352 in the final cohort, of whom 1 008 045 (49·5%) were men and 1 028 307 (50·5%) were women, with a mean age of 60·7 years (SD 8·3, range 49-78). Data on ethnicity were not collected. Compared with people with no mental disorders, the adjusted analysis showed lower participation among people with mild or moderate mental disorders (men: participation difference -4·4 percentage points [95% CI -4·7 to -4·1]; women: -3·8 percentage points [-4·1 to -3·6]) and severe mental disorders (men: participation difference -13·8 percentage points [-14·3 to -13·3]; women: -15·4 percentage points [-15·8 to -14·9]). People with mental disorders had a higher proportion of positive faecal immunochemical test results, lower adherence to colonoscopy, and more incomplete colonoscopies than people without mental disorders. INTERPRETATION: People with mental disorders were less likely to participate in colorectal cancer screening than those without these disorders. Patients with mental disorders could benefit from support or encouragement from their general practitioner or mental health-care facility to participate in cancer screening. Potential interventions should consider type of mental disorder, as needs might differ. FUNDING: Danish Cancer Society, Danish Health Foundation.

Comparing clinical trial population representativeness to real-world populations: an external validity analysis encompassing 43 895 trials and 5 685 738 individuals across 989 unique drugs and 286 conditions in England.

BACKGROUND: Randomised controlled trials (RCTs) inform prescription guidelines, but stringent eligibility criteria exclude individuals with vulnerable characteristics, which we define as comorbidities, concomitant medication use, and vulnerabilities due to age. Poor external validity can result in inadequate treatment decision information. Our first aim was to quantify the extent of exclusion of individuals with vulnerable characteristics from RCTs for all prescription drugs. Our second aim was to quantify the prevalence of individuals with vulnerable characteristics from population electronic health records who are actively prescribed such drugs. In tandem, these two aims will allow us to assess the representativeness between RCT and real-world populations and identify vulnerable populations potentially at risk of inadequate treatment decision information. When a vulnerable population is highly excluded from RCTs but has a high prevalence of individuals actively being prescribed the same medication, there is likely to be a gap in treatment decision information. Our third aim was to investigate the use of real-world evidence in contributing towards quantifying missing treatment risk or benefit through an observational study. METHODS: We extracted RCTs from ClinicalTrials.gov from its inception to April 28, 2021, and primary care records from the Clinical Practice Research Datalink Gold database from Jan 1, 1998, to Dec 31, 2020. We referred to the British National Formulary to classify prescription drugs into drug categories. We conducted descriptive analyses and quantified RCT exclusion and prevalence of individuals with vulnerable characteristics for comparison to identify populations without treatment decision information. Exclusion and prevalence were assessed separately for different age groups, individual clinical specialities, and for quantities of concomitant conditions by clinical specialities, where multimorbidity was defined as having two or more clinical specialties, and medications prescribed, where polypharmacy was defined as having five or more medications prescribed. Population trends of individuals with multimorbidity or polypharmacy were assessed separately by age group. We conducted an observational cohort study to validate the use of real-world evidence in contributing towards quantifying treatment risk or benefit for patients with dementia on anti-dementia drugs with and without a contraindicated clinical speciality. To do so, we identified the clinical specialities that anti-dementia drug RCTs highly excluded yet had corresponding high prevalence in the real-world population, forming the groups with highest risk of having scarce treatment decision information. Cox regression was used to assess if the risk of mortality outcomes differs between both groups. FINDINGS: 43 895 RCTs from ClinicalTrials.gov and 5 685 738 million individuals from primary care records were used. We considered 989 unique drugs and 286 conditions across 13 drug-category cohorts. For the descriptive analyses, the median RCT exclusion proportion across 13 drug categories was 81·5% (IQR 76·7-85·5) for adolescents (aged <18 years), 26·3% (IQR 21·0-29·5) for individuals older than 60 years, 40·5% (IQR 33·7-43·0) for individuals older than 70 years, and 52·9% (IQR 47·1-56·0) for individuals older than 80 years. Multimorbidity had a median exclusion proportion of 91·1% (IQR 88·9-91·8) and median prevalence of 41·0% (IQR 34·9-46·0). Concomitant medication use had a median exclusion proportion of 52·5% (IQR 50·0-53·7) and a median prevalence of 94·3% (IQR 84·3-97·2), and polypharmacy had a median prevalence of 47·7% (IQR 38·0-56·1). Population trends show increasing multimorbidity with age and consistently high polypharmacy across age groups. Populations with cardiovascular or otorhinolaryngological comorbidities had the highest risk of having scarce treatment decision information. For the observational study, populations with cardiovascular or psychiatric comorbidities had highest risk of having scarce treatment decision information. Patients with dementia with an anti-dementia prescription and contraindicated cardiovascular condition had a higher risk of mortality (hazard ratio [HR] 1·20 [95% CI 1·13-1·28 ; p<0·0001]) compared with patients with dementia without a contraindicated cardiovascular condition. Patients with dementia with comorbid delirium (HR 1·25 [95% CI 1·06-1·48]; p<0·0088), intellectual disability (HR 2·72 [95% CI 1·53-4·81]; p=0·0006), and schizophrenia and schizotypal delusional disorders (HR 1·36 [95% CI 1·02-1·82]; p=0·036) had a higher risk of mortality compared with patients with dementia without these conditions. INTERPRETATION: Overly stringent RCT exclusion criteria do not appropriately account for the heterogeneity of vulnerable characteristics observed in real-world populations. Treatment decision information is scarce for such individuals, which might affect health outcomes. We discuss the challenges facing the inclusivity of such individuals and highlight the strength of real-world evidence as an integrative solution in complementing RCTs and increasing the completeness of evidence-based medicine assessments in evaluating the effectiveness of treatment decisions. FUNDING: Wellcome Trust, National Institute for Health Research (NIHR) University College London Hospitals Biomedical Research Centre, NIHR Great Ormond Street Hospital Biomedical Research Centre, Academy of Medical Sciences, and the University College London Overseas Research Scholarship.

Dyadic Enrollment in a Phase 3 Mild Cognitive Impairment Clinical Trial.

BACKGROUND: Dyadic enrollment of a participant and study partner is required in mild cognitive impairment (MCI) clinical trials, despite participants being functionally independent. Research examining how the study partner requirement impacts MCI trials remains limited. METHODS: Using the Alzheimer's Disease Cooperative Study donepezil and vitamin E MCI trial data, we quantified the proportions of enrolled spouse, adult child, and other dyads. We used multinomial regression to identify which baseline participant characteristics (age, sex, race and ethnicity, apolipoprotein E ε4 status, education, residence type) were associated with dyad type. RESULTS: Among 769 randomized dyads, 73% were spousal, 14% adult child, and 13% other dyads. Adjusting for multiple comparisons, underrepresented racial and ethnic background (eg, comparing Hispanic to non-Hispanic White participants: adult child vs. spouse odds ratio = 5.86; 95% confidence interval: 2.09, 16.5; other vs. spouse odds ratio = 4.95; 95% confidence interval: 1.83, 13.4), female sex, age, nonhouse residence, and apolipoprotein E ε4 noncarriage were each associated with a higher odds of having an adult child, as well as an other, study partner at enrollment. DISCUSSION: Increasing participation among nonspousal dyads may facilitate more inclusive and representative MCI trial samples.

Patterns of Enrollment in Cancer Treatment Trials During the COVID-19 Pandemic at National Cancer Institute-Designated Cancer Centers.

ABSTRACT: The COVID-19 pandemic posed unprecedented strain on enrollment to cancer clinical trials and their conduct. Here, we highlight an analysis using information from the National Cancer Institute (NCI) Clinical Trials Reporting Program database to describe enrollment patterns to interventional cancer treatment trials at NCI-Designated Cancer Centers during the pandemic. Enrollment to cancer treatment trials at NCI-Designated Cancer Centers decreased precipitously early in the pandemic and has not yet fully returned to the 2019 baseline as of mid-2021. We discuss possible reasons for this and how some of the changes in clinical trial conduct implemented during the pandemic may become part of the standard conduct of NCI-supported clinical trials and broaden access to trials.

Ethnic inequalities in COVID-19 vaccine uptake and comparison to seasonal influenza vaccine uptake in Greater Manchester, UK: A cohort study.

BACKGROUND: COVID-19 vaccine uptake is lower amongst most minority ethnic groups compared to the White British group in England, despite higher COVID-19 mortality rates. Here, we add to existing evidence by estimating inequalities for 16 minority ethnic groups, examining ethnic inequalities within population subgroups, and comparing the magnitudes of ethnic inequalities in COVID-19 vaccine uptake to those for routine seasonal influenza vaccine uptake. METHODS AND FINDINGS: We conducted a retrospective cohort study using the Greater Manchester Care Record, which contains de-identified electronic health record data for the population of Greater Manchester, England. We used Cox proportional hazards models to estimate ethnic inequalities in time to COVID-19 vaccination amongst people eligible for vaccination on health or age (50+ years) criteria between 1 December 2020 and 18 April 2021 (138 days of follow-up). We included vaccination with any approved COVID-19 vaccine, and analysed first-dose vaccination only. We compared inequalities between COVID-19 and influenza vaccine uptake adjusting by age group and clinical risk, and used subgroup analysis to identify populations where inequalities were widest. The majority of individuals (871,231; 79.24%) were White British. The largest minority ethnic groups were Pakistani (50,268; 4.75%), 'other White background' (43,195; 3.93%), 'other ethnic group' (34,568; 3.14%), and Black African (18,802; 1.71%). In total, 83.64% (919,636/1,099,503) of eligible individuals received a COVID-19 vaccine. Uptake was lower compared to the White British group for 15 of 16 minority ethnic groups, with particularly wide inequalities amongst the groups 'other Black background' (hazard ratio [HR] 0.42, 95% CI 0.40 to 0.44), Black African (HR 0.43, 95% CI 0.42 to 0.44), Arab (HR 0.43, 95% CI 0.40 to 0.48), and Black Caribbean (HR 0.43, 95% CI 0.42 to 0.45). In total, 55.71% (419,314/752,715) of eligible individuals took up influenza vaccination. Compared to the White British group, inequalities in influenza vaccine uptake were widest amongst the groups 'White and Black Caribbean' (HR 0.63, 95% CI 0.58 to 0.68) and 'White and Black African' (HR 0.67, 95% CI 0.63 to 0.72). In contrast, uptake was slightly higher than the White British group amongst the groups 'other ethnic group' (HR 1.11, 95% CI 1.09 to 1.12) and Bangladeshi (HR 1.08, 95% CI 1.05 to 1.11). Overall, ethnic inequalities in vaccine uptake were wider for COVID-19 than influenza vaccination for 15 of 16 minority ethnic groups. COVID-19 vaccine uptake inequalities also existed amongst individuals who previously took up influenza vaccination. Ethnic inequalities in COVID-19 vaccine uptake were concentrated amongst older and extremely clinically vulnerable adults, and the most income-deprived. A limitation of this study is the focus on uptake of the first dose of COVID-19 vaccination, rather than full COVID-19 vaccination. CONCLUSIONS: Ethnic inequalities in COVID-19 vaccine uptake exceeded those for influenza vaccine uptake, existed amongst those recently vaccinated against influenza, and were widest amongst those with greatest COVID-19 risk. This suggests the COVID-19 vaccination programme has created additional and different inequalities beyond pre-existing health inequalities. We suggest that further research and policy action is needed to understand and remove barriers to vaccine uptake, and to build trust and confidence amongst minority ethnic communities.

Willingness to take COVID-19 vaccination in low-income countries: Evidence from Ethiopia.

BACKGROUND: In low-income countries, vaccination campaigns are lagging, and evidence on vaccine acceptance, a crucial public health planning input, remains scant. This is the first study that reports willingness to take COVID-19 vaccines and its socio-demographic correlates in Ethiopia, Africa's second most populous country. METHODS: The analysis is based on a nationally representative survey data of 2,317 households conducted in the informal economy in November 2020. It employs two logistic regression models where the two outcome variables are (i) a household head's willingness to take a COVID-19 vaccine or not, and (ii) if yes if they would also hypothetically pay (an unspecified amount) for it or not. Predictors include age, gender, education, marital status, income category, health insurance coverage, sickness due to COVID-19, chronic illness, trust in government, prior participation in voluntary activities, urban residence. RESULTS: Willingness to take the vaccine was high (88%) and significantly associated with COVID-19 cases in the family, trust in government and pro-social behavior. All other predictors such as gender, education, income, health insurance, chronic illness, urban residence did not significantly predict vaccine willingness at the 5% level. Among those willing to take the vaccine, 33% also answered that they would hypothetically pay (an unspecified amount) for it, an answer that is significantly associated with trust in government, health insurance coverage and income. CONCLUSION: The results highlight both opportunities and challenges. There is little evidence of vaccine hesitancy in Ethiopia among household heads operating in the informal economy. The role played by trust in government and pro-social behavior in motivating this outcome suggests that policy makers need to consider these factors in the planning of COVID-19 vaccine campaigns in order to foster vaccine uptake. At the same time, as the willingness to hypothetically pay for a COVID-19 vaccine seems to be small, fairly-priced vaccines along with financial support are also needed to ensure further uptake of COVID-19 vaccines.

Mode of Physical Activity Participation in US Adults: A Regional Perspective.

OBJECTIVE: Examine the mode of physical activity (PA) participation in United States adults by US Census region. METHODS: The study sample (N = 323,435) included adult (18 years of age and older) participants from the 2019 Behavioral Risk Factor Surveillance System. Participants reported meeting both aerobic and muscle strengthening activity (MSA) guidelines, the aerobic-only guideline, the MSA only guideline, or neither. RESULTS: The greatest prevalence estimate of meeting the mutually exclusive aerobic and MSA guideline was found in the West Census Region (24.3, 95% confidence interval 23.6-24.9) and the greatest prevalence estimate of meeting neither aerobic nor MSA guideline was found in the South Census Region (38.1%, 95% confidence interval 37.5-38.7). Physical and mental health were found to be positively associated with PA and non-Hispanic Blacks and Hispanics reported the greatest levels of meeting neither federal PA recommendation. CONCLUSIONS: These data suggest that mode of PA participation varies by demographics and census region in US adults. State and local health departments should communicate between and within regions and disseminate information to raise awareness of the health benefits of meeting the federal PA guidelines.

Flemish population-based cancer screening programs: impact of COVID-19 related shutdown on short-term key performance indicators.

BACKGROUND: Many breast, colorectal, and cervical cancer screening programs were disrupted due to the COVID-19 pandemic. This study aimed to estimate the short-term impact of the temporary shutdown (from March until May- June) of the cancer screening programs invitations in Flanders (Belgium) by looking at invitation coverage, percentage of people screened after invitation and the screening interval. METHODS: Yearly invitation coverage was calculated as the number of people who received an invitation, as a proportion of the people who should have received an invitation that year. Weekly response to the invitation was calculated as the number of people who were screened within 40 days of their date of invitation, as a percentage of the people who received an invitation that week (as a proxy for willingness to screen). Weekly screening interval was calculated as the mean number of months between the current screening and the previous screening of all the people who screened that week. The two last indicators were calculated for each week in 2019 and 2020, after which the difference between that week's value in 2020 and 2019 with 95% confidence intervals. Results of these two indicators were also analysed after stratification for gender, age and participation history. RESULTS: Invitation coverage was not impacted in the colorectal and cervical cancer screening program. In the breast cancer screening program invitation coverage went down from 97.5% (2019) to 88.7% (2020), and the backlog of invitations was largely resolved in the first six months of 2021. The willingness to screen was minimally influenced by COVID-19. The breast cancer screening program had a temporary increase in screening interval in the first months following the restart after COVID-19 related shutdown, when it was on average 2.1 months longer than in 2019. CONCLUSIONS: Willingness to screen was minimally influenced by COVID-19, but there may be an influence on screening coverage because of lower invitation coverage, mainly for the for breast Cancer Screening Program. The increases in screening intervals for the three Cancer Screening Program seem reasonable and would probably not significantly increase the risk of delayed screening cancer diagnoses. When restarting a Cancer Screening Program after a COVID-19 related shutdown, monitoring is crucial.

Clinical research on COVID-19: perceptions and barriers to participation in The Gambia.

INTRODUCTION: The need to rapidly identify safe and efficacious drug therapies for COVID-19 has resulted in the implementation of multiple clinical trials investigating potential treatment options. These are being undertaken in an unprecedented research environment and at a higher speed than ever before. It is unclear how West African communities perceive such activities and how such perceptions influence participation in COVID-19 clinical trials. This qualitative study was conducted to assess the level of acceptability of a clinical trial on the prevention and treatment of COVID-19 in The Gambia and identify strategies to better engage communities in participating in such a trial. METHODS: Data were collected using digitally recorded semistructured interviews (SSIs) and focus group discussions (FGDs) in Brikama and Kanifing local government areas. These are two of the most densely populated administrative subdivisions in The Gambia, where the clinical trial was to be implemented by the MRC Unit The Gambia. 26 men and 22 women aged between 19 and 70 years, with diverse socioeconomic profiles, participated in 8 FGDs (n=36) and 12 SSIs (n=12). Thematic analysis was used to analyse the data. RESULTS: Fear of stigmatisation of patients with COVID-19 was a recurring theme in most FGDs and SSIs, with detrimental effects on willingness to accept COVID-19 testing and home visits to follow up patients with COVID-19 and their household contacts. Preserving the privacy of individuals enrolled in the study was key to potentially increase trial participation. Trust in the implementing institution and its acknowledged expertise were facilitators to accepting the administration of investigational products to sick individuals and their close contacts. CONCLUSION: COVID-19 is a stigmatising disease. Developing a research-participant collaboration through an ongoing engagement with community members is crucial to a successful enrolment in COVID-19 clinical trials. Trust and acknowledged expertise of the implementing institution are key facilitators to foster such collaboration.

The Patient Navigator: Can a systematically developed online health information tool improve patient participation and outcomes related to the consultation in older patients newly diagnosed with colorectal cancer?

BACKGROUND: Older cancer patients may search for health information online to prepare for their consultations. However, seeking information online can have negative effects, for instance increased anxiety due to finding incorrect or unclear information. In addition, existing online cancer information is not necessarily adapted to the needs of older patients, even though cancer is a disease often found in older individuals. OBJECTIVE: The aim of this study was to systematically develop, implement and evaluate an online health information tool for older cancer patients, the Patient Navigator, providing information that complements the consultation with healthcare providers. METHOD: For the development and evaluation of the Patient Navigator, the four phases of the MRC framework were used. In the first and second phase the Patient Navigator was developed and pilot tested based on previous research and sub-studies. During the third phase the Patient Navigator was implemented in four Dutch hospitals. In the last phase, a pilot RCT was conducted to evaluate the Patient Navigator in terms of usage (observational tracking data), user experience (self-reported satisfaction, involvement, cognitive load, active control, perceived relevance of the tool), patient participation (observational data during consultation), and patient outcomes related to the consultation (questionnaire data regarding anxiety, satisfaction, and information recall). Recently diagnosed colorectal cancer patients (N = 45) were randomly assigned to the control condition (usual care) or the experimental condition (usual care + Patient Navigator). RESULTS: The Patient Navigator was well used and evaluated positively. Patients who received the Patient Navigator contributed less during the consultation by using less words than patients in the control condition and experienced less anxiety two days after the consultation than patients in the control condition. CONCLUSION: Since the Patient Navigator was evaluated positively and decreased anxiety after the consultation, this tool is potentially a valuable addition to the consultation for patients. Usage of the Patient Navigator resulted in patients using less words during consultations, without impairing patients' satisfaction, possibly because information needs might be fulfilled by usage of the Patient Navigator. This could create the possibility to personalize communication during consultations and respond to other patient needs.

Using social media to crowdsource collection of urine samples during a national pandemic.

The COVID-19 pandemic and subsequent lockdown had a substantial impact on normal research operations. Researchers needed to adapt their methods to engage at-home participants. One method is crowdsourcing, in which researchers use social media to recruit participants, gather data, and collect samples. We utilized this method to develop a diagnostic test for Interstitial Cystitis/Bladder Pain Syndrome (IC/BPS). Participants were recruited via posts on popular social-media platforms, and enrolled via a website. Participants received and returned a mail kit containing bladder symptom surveys and a urine sample cup containing room-temperature preservative. Using this method, we collected 1254 IC/BPS and control samples in 3 months from all 50 United States. Our data demonstrate that crowdsourcing is a viable alternative to traditional research, with the ability to reach a broad patient population rapidly. Crowdsourcing is a powerful tool for at-home participation in research, particularly during the lockdown caused by the COVID-19 pandemic.

COVID-19 vaccine uptake and hesitancy opinions from frontline health care and social care workers: Survey data from 37 countries.

BACKGROUND AND AIMS: Vaccine hesitancy is an ongoing major challenge. We aimed to assess the uptake and hesitancy of the COVID-19 vaccination. METHODS: A short online survey was posted between April 12 to July 31, 2021 targeted at health and social care workers (HCWs) across the globe. RESULTS: 275 from 37 countries responded. Most were hospital or primary care physicians or nurses, 59% women, aged 18-60 years, and 21% had chronic conditions with most prevalent being diabetes, hypertension, and asthma. We found that most HCWs (93%) had taken or willing to receive the COVID-19 vaccine. While 7% were vaccine hesitant (mainly women aged 30-39 years), respondents main concerns was the safety or potential side effects. Vaccine willing respondents raised concerns of unequal access to the COVID-19 vaccination in some countries, and highlighted that the only solution to overcoming COVID-19 infections was the vaccine booster doses given annually and free mass vaccination. CONCLUSIONS: This study found that the majority of the frontline HCWs are willing to receive the COVID-19 vaccine. Further promotion of the COVID-19 vaccine would reassure and persuade HCWs to become vaccinated.

Parent Perceptions in Choosing Treatment for Infants With Spinal Muscular Atrophy Diagnosed Through Newborn Screening.

OBJECTIVE: To identify factors parents considered in treatment decision making for children diagnosed with spinal muscular atrophy on newborn screening. METHODS: Participants were recruited through the University of Rochester or through flyers and Cure SMA social media outreach and asked to complete a telephone or online survey. Data were analyzed through mixed methods using descriptive statistics and theme identification in narrative responses. RESULTS: Eighteen parents with children diagnosed with spinal muscular atrophy on newborn screening participated. Thirteen of 18 chose onasemnogene abeparvovec, 2 of 18 chose risdiplam, 1 of 18 chose nusinersen, and 2 of 18 did not receive treatment. The most commonly reported factors impacting treatment choice included treatment frequency and administration method. Seventeen (94.4%) parents felt that inclusion of spinal muscular atrophy on newborn screening was positive because it could allow for better outcomes with earlier treatment. CONCLUSION: Treatment frequency and administration method were the most important factors for parents in determining spinal muscular atrophy treatment. Parents felt positively about newborn screening due to opportunity for earlier treatment.

Empowering patients with the PREPARE advance care planning program results in reciprocal clinician communication.

BACKGROUND: The patient-directed PREPAREforYourCare.org program empowers patients to participate in advance care planning (ACP) discussions with clinicians. Our goal was to determine whether PREPARE could reciprocally increase clinician ACP communication. METHODS: In a secondary analysis of two trials evaluating the efficacy of PREPARE plus an easy-to-read advance directive (AD) versus an AD alone, patients were included if they were ≥55 years old, English- or Spanish-speaking, and had ≥2 chronic conditions. We audio-recorded postintervention primary care visits and used the validated clinician-patient participation coding scheme to calculate the number of clinician ACP utterances concerning information-giving, recommendations, or supportive talk. We examined differences by study arm using mixed effects negative binomial models, stratifying by language. To assess possible mediation, we adjusted for active patient participation (e.g., asking questions or stating preferences). RESULTS: Three hundred ninety-three visits were audio-recorded (177 in PREPARE arm and 216 in AD-only arm). Recordings included 179 clinicians (mean 2.2 [SD 1.9] patients each). Patients' mean age was 66 ± 8 years, 31% had limited health literacy, and 25% were Spanish-speaking. Exactly 67% of recordings included information-giving, 85% recommendations, and 62% supportive talk. PREPARE resulted in 51% more clinician supportive talk versus the AD alone (mean 4.5 [8.9] vs. 2.9 [6.0] utterances; incidence rate ratio 1.51 [95% CI 1.02-2.24]). Effects were most pronounced among Spanish speakers. There were no differences in information-giving or recommendations. After adjusting for active patient participation, no differences in supportive talk remained. CONCLUSIONS: The patient-directed PREPARE program was associated with greater clinician supportive ACP communication with older adults compared with an AD alone; the effect was most pronounced among Spanish speakers and was mediated by active patient participation. Thus, PREPARE helps patients be more engaged communicators, which in turn encourages clinicians to be more supportive of patients. Enhanced patient-clinician communication represents an important mechanism by which PREPARE may decrease disparities in ACP.

Community-Based Participatory Research (CBPR) to Enhance Participation of Racial/Ethnic Minorities in Clinical Trials: A 10-Year Systematic Review.

There has not been a significant improvement in the rate of clinical trial accrual in more than 20 years. Worse, the challenge of inadequate representation among racial and ethnic minorities also persists, deepening disparities in health. Community-Based Participatory Research (CBPR) is a participatory communication method that centers on effective dialogue between researchers and community stakeholders with the goal of creating an equitable partnership for health and social change. The objective of the current study was to provide an update since a systematic review in 2012, on the current status of the empirical research, with a particular focus on the elements of CBPR methods used to improve the rate of accrual of members of racial and ethnic minority communities for clinical trials. Our systematic review found a large increase in the number of CBPR related studies and studies related to racial and ethnic representation in research. More than 85% of studies employing CBPR methods saw statistically positive outcomes. Specifically, the elements of CBPR that are associated with these positive outcomes include community partner participation in (1) a study advisory committee, (2) data collection, (3) the development of interventions, and (4) participant recruitment. However, the results of our study indicate that researchers need to be more transparent about the extent of community participation as well as more thoroughly and accurately describe the nature of the partnership with members of minority communities in order to build upon the scientific literature on community-engaged methods.