Disparities in Patient Portal Engagement Among Patients With Hypertension Treated in Primary Care.

Importance: Patient portals are increasingly used for patient-clinician communication and to introduce interventions aimed at improving blood pressure control. Objective: To characterize patient portal use among patients with hypertension managed in primary care. Design, Settings, and Participants: This retrospective cohort study used electronic health records linked with patient portal log file data from a large, diverse Midwestern health care system. Patients with hypertension who had a primary care visit from January 1, 2021, to December 31, 2021, were included. The first visit in 2021 was considered the baseline visit; patient portal engagement was evaluated during the following year. Multivariate logistic regressions, presented as odds ratios (ORs) and 95% CIs, were used to evaluate associations between patient characteristics and patient portal engagement, adjusting for potential confounders. Exposures: Primary exposures included 4 sociodemographic factors routinely collected in the electronic health record: race and ethnicity, insurance, preferred language, and smoking status. Main Outcomes and Measures: Indicators of patient engagement with the patient portal included accessing the patient portal at least once, accessing the portal within 7 days of at least 50.0% of primary care physician (PCP) visits, frequent logins (<28 vs ≥28), messaging (<2 vs ≥2), and sharing home blood pressure readings. Results: Among 366 871 patients (mean [SD], 63.5 [12.6] years), 52.8% were female, 3.4% were Asian, 7.8% were Hispanic, 19.7% were non-Hispanic Black, 66.9% were non-Hispanic White, and 2.3% were of other race or ethnicity. During the 1-year study period starting in 2021, 70.5% accessed the patient portal at least once, 60.2% accessed around the time of their PCP visits, 35.7% accessed the portal frequently, 28.9% engaged in messaging, and 8.7% shared home blood pressure readings. Compared with White patients, non-Hispanic Black and Hispanic patients had lower odds of any access (Black: OR, 0.53; 95% CI, 0.52-0.54; Hispanic: OR, 0.66; 95% CI, 0.64-0.68), access around PCP visit time (Black: OR, 0.49; 95% CI, 0.48-0.50; Hispanic: OR, 0.62; 95% CI, 0.60-0.64), frequent access (Black: OR, 0.56; 95% CI, 0.55-0.57; Hispanic: OR, 0.71; 95% CI, 0.69-0.73), and messaging (Black: OR, 0.63; 95% CI, 0.61-0.64); Hispanic: OR, 0.71; 95% CI, 0.69-0.73). Conclusions and Relevance: This cohort study of patients with hypertension found clear sociodemographic disparities in patient portal engagement among those treated in primary care. Without special efforts to engage patients with portals, interventions that use patient portals to target hypertension may exacerbate disparities.

Using brief reflections to capture and evaluate end-user engagement: a case example using the COMPASS study.

BACKGROUND: Use of participatory research methods is increasing in research trials. Once partnerships are established with end-users, there is less guidance about processes research teams can use to successfully incorporate end-user feedback. The current study describes the use of a brief reflections process to systematically examine and evaluate the impact of end-user feedback on study conduct. METHODS: The Comparative Effectiveness of Trauma-Focused and Non-Trauma- Focused Treatment Strategies for PTSD among those with Co-Occurring SUD (COMPASS) study was a randomized controlled trial to determine the effectiveness of trauma-focused psychotherapy versus non-trauma-focused psychotherapy for Veterans with co-occurring posttraumatic stress disorder and substance use disorder who were entering substance use treatment within the Department of Veterans Affairs. We developed and paired a process of "brief reflections" with our end-user engagement methods as part of a supplemental evaluation of the COMPASS study engagement plan. Brief reflections were 30-minute semi-structured discussions with the COMPASS Team following meetings with three study engagement panels about feedback received regarding study issues. To evaluate the impact of panel feedback, 16 reflections were audio-recorded, transcribed, rapidly analyzed, and integrated with other study data sources. RESULTS: Brief reflections revealed that the engagement panels made recommended changes in eight areas: enhancing recruitment; study assessment completion; creating uniformity across Study Coordinators; building Study Coordinator connection to Veteran participants; mismatch between study procedures and clinical practice; therapist skill with patients with active substance use; therapist burnout; and dissemination of study findings. Some recommendations positively impact study conduct while others had mixed impact. Reflections were iterative and led to emergent processes that included revisiting previously discussed topics, cross-pollination of ideas across panels, and sparking solutions amongst the Team when the panels did not make any recommendations or recommendations were not feasible. CONCLUSIONS: When paired with end-user engagement methods, brief reflections can facilitate systematic examination of end-user input, particularly when the engagement strategy is robust. Reflections offer a forum of accountability for researchers to give careful thought to end-user recommendations and make timely improvements to the study conduct. Reflections can also facilitate evaluation of these recommendations and reveal end-user-driven strategies that can effectively improve study conduct. TRIAL REGISTRATION: ClinicalTrials.gov (NCT04581434) on October 9, 2020; https://clinicaltrials.gov/ct2/show/study/NCT04581434?term=NCT04581434&draw=2&rank=1 .

Patient activation and medication adherence in adults.

BACKGROUND: Patients' level of medication adherence provides conflicting results in its relationship to patient activation. Multiple factors may be contributing to these mixed results. OBJECTIVES: The primary purpose was to assess the association of patient activation to medication adherence in adults with chronic health conditions and low health literacy (HL). Secondary objectives were to determine whether age, education, gender, and race were associated with activation. METHODS: Participants completed self-report questionnaires regarding chronic disease self-management. Patient activation was measured using Hibbard's Patient Activation Measure (PAM). Self-report of medication adherence was determined using the Gonzalez-Lu adherence questionnaire. Block regressions first assessed the relation of demographic variables and education to adherence and then the added relation of patient activation in a second model. RESULTS: The analyses included 301 participants (mean age 58 years; 53% female; mean chronic conditions of 6.6). Some of the most common chronic conditions included hypertension (60%), arthritis (51%), depression (49%), and hyperlipidemia (43%). The relation of older age to greater medication adherence was significant (P < 0.05) in both models. The addition of PAM was significantly related to better adherence (P < 0.001) and also increased the R squared value from 0.04 to 0.09. This change resulted in a moderate effect size (d = 0.50). CONCLUSION: Evaluating patient activation at baseline may predict those more likely to be medication adherent in patients with low HL.

Temporal Trends in Cardiac Rehabilitation Participation and Its Core Components: A Nationwide Cohort Study From the Netherlands.

PURPOSE: Patient- and disease-specific data on cardiac rehabilitation (CR) participation and changes over time are limited. The objective of this study was to describe time trends in CR participation between 2013 and 2019 and provides insights into the utilization of CR components. METHODS: Patients with cardiovascular disease (CVD) with an indication for CR were enrolled between 2013 and 2019. Dutch health insurance claims data were used to identify CR participation and its components. RESULTS: In total, 106 212 patients with CVD were included of which 37% participated in CR. Participation significantly increased from 28% in 2013 to 41% in 2016 but remained unchanged thereafter. Participation was highest in the youngest age groups (<50 yrs 52%; 50-65 yrs 50%), men (48%), patients with ST-segment elevation myocardial infarction (73%), non-ST-segment elevation myocardial infarction (59%), and coronary artery bypass grafting (82%). In contrast, it was the lowest in the oldest age group (≥85 yrs 8%), women (30%), and in patients with heart failure (11%). Most participants in CR received referral plus an admission session (97%) and exercise training (82%), whereas complementary services related to dietary (14%) and mental health counseling (10%) had a low utilization. CONCLUSIONS: CR participation rates increased to 41% in 2016 but remained unchanged thereafter. Participation modulators included age, sex, CVD diagnosis, and undergoing a cardiothoracic procedure. Education and exercise sessions were frequently adopted, but dietary and mental health counseling had a low utilization rate. These findings suggest the need for reinvigorated referral and novel enrollment strategies in specific CVD subgroups to further promote CR participation and its associated underutilized adjunctive services.

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.

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.

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.

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.

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.

Paying patients to use lower-priced providers.

OBJECTIVE: Many employers have introduced rewards programs as a new benefit design in which employees are paid $25-$500 if they receive care from lower-priced providers. Our goal was to assess the impact of the rewards program on procedure prices and choice of provider and how these outcomes vary by length of exposure to the program and patient population. STUDY SETTING: A total of 87 employers from across the nation with 563,000 employees and dependents who have introduced the rewards program in 2017 and 2018. STUDY DESIGN: Difference-in-difference analysis comparing changes in average prices and market share of lower-priced providers among employers who introduced the reward program to those that did not. DATA COLLECTION METHODS: We used claims data for 3.9 million enrollees of a large health plan. PRINCIPAL FINDINGS: Introduction of the program was associated with a 1.3% reduction in prices during the first year and a 3.7% reduction in the second year of access. Use of the program and price reductions are concentrated among magnetic resonance imaging (MRI) services, for which 30% of patients engaged with the program, 5.6% of patients received an incentive payment in the first year, and 7.8% received an incentive payment in the second year. MRI prices were 3.7% and 6.5% lower in the first and second years, respectively. We did not observe differential impacts related to enrollment in a consumer-directed health plan or the degree of market-level price variation. We also did not observe a change in utilization. CONCLUSIONS: The introduction of financial incentives to reward patients from receiving care from lower-priced providers is associated with modest price reductions, and savings are concentrated among MRI services.