ABSTRACT
This paper examines whether school COVID-19 policies influenced enrollment differently by student age and race/ethnicity. Unlike much prior research, we i) analyze enrollments for virtually the entire U.S. public school population for both the 2020-2021 and 2021-2022 school years, ii) compare enrollment trends within districts in order to isolate subgroup heterogeneity from district characteristics, and iii) account for district selection into preferred learning modes. Analyzing data on over 9,000 districts that serve more than 90% of public school students in the United States, we find enrollment responses to COVID policies differed notably. We find that White enrollments declined more than Black, Hispanic, and Asian enrollments in districts that started the 2020-2021 school year virtually, but in districts that started in-person the reverse was true: Non-White enrollments declined more than White enrollments. Moreover, Black, Hispanic, and Asian families responded more than White families to higher COVID-19 death rates in the months preceding the start of the 2021 school year. In 2021-2022, enrollment differences by the previous year's learning mode persisted. Racial/ethnic differences did not vary by whether the district required masking in classrooms. These findings are consistent with the greater risk faced by communities of color during the pandemic and demonstrate an additional source of disparate impact from COVID policies.
Subject(s)
COVID-19 , Humans , Race Factors , COVID-19/epidemiology , Educational Status , Parents , PolicyABSTRACT
BACKGROUND: Identifying patient- and disease-specific characteristics associated with clinical trial enrollment of adolescents and young adults (AYAs) with cancer may target efforts to improve accrual. METHODS: Alliance for Clinical Trials in Oncology (Alliance) trials opened from January 1, 2000, and closed before January 1, 2018, for common AYA cancers were identified. Proportions of AYAs (aged 18-39 years old) versus non-AYAs (aged ≥40 years old) enrolled by cancer type were summarized by descriptive statistics. Among studies with ≥20 AYAs enrolled, demographic and disease characteristics of AYAs versus non-AYAs were compared with χ2 and Kruskal-Wallis tests. A qualitative review was also conducted of therapeutic trials included in analysis in PubMed through December 31, 2021, that reported AYA-specific survival. RESULTS: Among 188 trials enrolling 40,396 patients, AYAs represented 11% (4468 of 40,396) of accrual. AYA accrual varied by cancer type (leukemia, 23.6%; breast, 9.9%; lymphoma, 14.8%; colorectal, 6.2%; central nervous system, 8.1%; melanoma, 11.8%; sarcoma, 12%). Across ages, the proportion of Black and Hispanic patients enrolled was 1%-10%. Compared to non-AYAs, AYAs in breast and colorectal cancer trials were less likely to be White and more likely to be Hispanic. Disease characteristics differed by age for selected trials. Two trials reported AYA-specific survival, with no significant differences observed by age. CONCLUSIONS: AYA accrual to Alliance trials was comparable to or exceeded population-based, age-specific prevalence estimates for most cancer types. Greater proportional representation of Hispanic and non-White patients among AYAs reflects US demographic trends. The small number of minority patients enrolled across ages underscores the persistent challenge of ensuring equitable access to trials, including for AYAs.
Subject(s)
Leukemia , Melanoma , Neoplasms , Sarcoma , Humans , Adolescent , Young Adult , Adult , Neoplasms/epidemiology , Neoplasms/therapy , Medical Oncology , BreastABSTRACT
Enrollment in cancer clinical trials cannot occur without first successfully identifying trials for which patients are a match based on their clinical characteristics. A lack of onsite matching trials has been identified as the single largest barrier preventing patients from participating in clinical trials. The site-agnostic cancer clinical trial matching environment is a mix of public and private tools and infrastructure that are not designed to work together to facilitate trial matching in an efficient manner. To identify policy and infrastructure solutions that could enable more effective and more frequent use of third-party site-agnostic matching, the American Cancer Society Cancer Action Network held a summit to examine challenges and propose consensus recommendations that could address those challenges. At this 2019 summit, stakeholders in this field examined these barriers and challenges and made a number of policy and infrastructure recommendations to improve the ability of this environment to work in a more coordinated and efficient manner.
Subject(s)
Neoplasms , Humans , Consensus , Neoplasms/therapy , Palliative Care , Clinical Trials as TopicABSTRACT
BACKGROUND: Provider and institutional practices have been shown to have a large impact on cancer clinical trial enrollment. Understanding provider perspectives on screening for trial eligibility is necessary to improve enrollment. METHODS: A questionnaire about incentives, barriers, process tools, and infrastructure related to opening trials and referring patients to onsite and offsite trials was administered to diverse stakeholders, including professional societies, advocacy organizations, and industry networks. Descriptive statistics were used to summarize findings. RESULTS: Overall, 693 responses were received, primarily from physicians (42.7%) and nurses (35.6%) employed at hospital health systems (43.7%) and academic centers (36.5%). Approximately half (49.2%) screened all patients for onsite clinical trials with screening typically done by manual chart review (81.9%). The greatest incentive reported for offering trials was providing the best treatment options for patients (67.7%). Contracting and paperwork (48.5%) were the greatest barriers to opening more onsite trials. Offsite referrals were rare. CONCLUSIONS: Screening for trial eligibility is a largely manual and ad hoc process, with screening and referral to offsite trials occurring infrequently. Administrative and infrastructure barriers commonly prevent sites from opening more onsite trials. These findings suggest that automated trial screening tools built into workflows that screen in a site-agnostic manner could result in more frequent trial eligibility screening, especially for offsite trials. With recent momentum, in part in response to the COVID-19 pandemic, to improve clinical trial efficiencies and broaden access and participant diversity, implementing tools to improve screening and referral processes is timely and essential. PLAIN LANGUAGE SUMMARY: There are many factors that contribute to low adult enrollment in cancer clinical trials, but previous research has indicated that provider and institutional barriers are the largest contributors to low cancer clinical trial enrollment. In this survey, we sought to gain insight into cancer clinical trial enrollment practices from the perspective of health care providers such as physicians and nurses. We found that only approximately half of respondents indicated their institution systematically screens their patients for clinical trials and this process is manual and time consuming. Furthermore, we found that providers infrequently search for and refer patients to clinical trials at other sites. Creating better screening methods could improve enrollment in clinical trials.
Subject(s)
Motivation , Neoplasms , Adult , Humans , Early Detection of Cancer , Neoplasms/diagnosis , Neoplasms/therapy , Pandemics , Referral and Consultation , Surveys and Questionnaires , Clinical Trials as TopicABSTRACT
OBJECTIVE: To describe the participation of racial and ethnic minority groups (REMGs) in gynecologic oncology trials. METHODS: Gynecologic oncology studies registered on ClinicalTrials.gov between 2007 and 2020 were identified. Trials with published results were analyzed based on reporting of race/ethnicity in relation to disease site and trial characteristics. Expected enrollment by race/ethnicity was calculated and compared to actual enrollment, adjusted for 2010 US Census population data. RESULTS: 2146 gynecologic oncology trials were identified. Of published trials (n = 252), 99 (39.3%) reported race/ethnicity data. Recent trials were more likely to report these data (36% from 2007 to 2009; 51% 2013-2015; and 53% from 2016 to 2018, p = 0.01). Of all trials, ovarian cancer trials were least likely to report race/ethnicity data (32.1% vs 39.3%, p = 0.011). Population-adjusted under-enrollment for Blacks was 7-fold in ovarian cancer, Latinx 10-fold for ovarian and 6-fold in uterine cancer trials, Asians 2.5-fold in uterine cancer trials, and American Indian and Alaska Native individuals 6-fold in ovarian trials. Trials for most disease sites have enrolled more REMGs in recent years - REMGs made up 19.6% of trial participants in 2007-2009 compared to 38.1% in 2016-2018 (p < 0.0001). CONCLUSION: Less than half of trials that published results reported race/ethnicity data. Available data reveals that enrollment of REMGs is significantly below expected rates based on national census data. These disparities persisted even after additionally adjusting for population size. Despite improvement in recent years, additional recruitment of REMGs is needed to achieve more representative and equitable participation in gynecologic cancer clinical trials.
Subject(s)
Genital Neoplasms, Female , Ovarian Neoplasms , Uterine Neoplasms , Humans , Female , United States , Genital Neoplasms, Female/therapy , Ethnicity , Ethnic and Racial Minorities , Minority Groups , Ovarian Neoplasms/therapy , Uterine Neoplasms/therapyABSTRACT
Despite dedicated efforts to improve equitable access to cancer care in the United States, disparities in cancer outcomes persist, and geographically underserved patients remain at an increased risk of cancer with lower rates of survival. The critical evaluation of cancer prevention inequities and clinical trial access presents the opportunity to outline novel strategies to incrementally improve bookended access to gynecologic cancer care for geographically underserved patients. Cancer prevention strategies that can be addressed in the rural patient population mirror priorities in the Healthy People 2030 objectives and include increased identification of high risk individuals who may benefit from increased cancer screening and risk reduction, increasing the proportion of people who discuss interventions to prevent cancer, such as HPV vaccination, with their provider, and increasing the proportion of adults who complete evidence based cancer screening. Barriers to accrual to clinical trials for rural patients overlap significantly with the same barriers to obtaining health care in general. These barriers include: lack of facilities and specialized providers; lack of robust health infrastructure; inability to travel; and financial barriers. In this review, we will discuss current knowledge and opportunities to improve cancer prevention initiatives and clinical trial enrollment in geographically underserved populations with a focus on rurality.
Subject(s)
Clinical Trials as Topic , Health Services Accessibility , Medically Underserved Area , Humans , Female , Rural Population , Genital Neoplasms, Female/prevention & control , United States/epidemiology , Healthcare Disparities , Patient Selection , Early Detection of Cancer/methodsABSTRACT
Dual-agent treatment has become more and more popular in clinical trials. We have developed an approach called rapid enrollment dual-agent design (REDD) for dose-finding in Phase I clinical trials. This approach aims to administer treatment to patients using a dose combination that is highly probable to be the target dose combination. Unlike other non-model-based designs, rapid enrollment designs (RED and REDD) do not require waiting for all patients to complete an assessment before the assignment of the next participant. Simulations showed that across several scenarios, the average performance of REDD is comparable to that of the Bayesian optimal interval (BOIN) design and the partial order continual reassessment method (POCRM). The simulation results of REDD for late-onset toxicity assessments demonstrated that assigning patients to a dose combination as they are being enrolled, without waiting for the most recent cohort of patients to complete their follow-up, does not significantly compromise the quality of the maximum tolerated dose (MTD) estimation. Instead, it saves a considerable amount of time in clinical trial enrollment. User-friendly online applications have also been created to further facilitate the adoption of rapid enrollment designs in Phase I trials. In summary, being similar to BOIN and POCRM in performance, REDD is an approach that is easily comprehensible, straightforward to implement and offers an advantage of enrolling patients without having to wait for all current patients to complete their follow-ups for toxicity.
ABSTRACT
OBJECTIVE: To explore the efficacy and safety of 5% lidocaine-medicated plaster (LMP) in patients with trigeminal neuralgia (TN). BACKGROUND: TN is an excruciatingly painful type of neuropathic facial pain. Anti-epileptics are the first-line treatment for TN; however, these oral drugs alone sometimes fail to achieve satisfactory analgesic effects. Two retrospective studies have shown that LMP can be an effective and safe treatment option for some patients with TN. No other high-quality clinical studies have explored the effect and safety of LMP in patients with TN. METHODS: The PATCH trial is an enriched enrollment with randomized withdrawal, double-blind, vehicle-controlled, parallel-group trial performed at five study centers. Eligible patients with TN received LMP during a 3-week initial open-label phase. Patients who met the response criteria entered the double-blind treatment phase and were randomly assigned for treatment with either LMP (LMP group) or vehicle patches (control group) at a 1:1 ratio. Patients who met the criteria for treatment failure were withdrawn from the double-blind treatment phase, and treatment was continued in the remaining patients for up to 28 days. The primary outcome was the number of treatment failures. The secondary endpoints were the time to loss of therapeutic response (LTR) in the double-blind phase and the weekly mean pain severity in both the open-label phase and the double-blind phase of the study. RESULTS: The first patient was enrolled in this study on May 1, 2021, and the enrollment of the last patient was completed on August 26, 2022. A total of 307 patients were initially screened, 226 (74.0%) of whom entered the open-label phase. Of the 226 respondents, 124 (55.0%) were randomized to the double-blind phase. In the double-blind phase, 62 patients were assigned to the LMP group, and 62 were assigned to the control group. For the primary endpoint, 16 (26.0%) patients with LMP and 36 (58.0%) patients with vehicle patches met the treatment failure criteria during the double-blind phase (relative risk, 0.48; 95% confidence interval [CI], 0.31 to 0.75; p < 0.001). The survival curve of the LTR showed that the LTR of LMP was significantly longer than that of the vehicle patches (hazard ratio, 0.275; 95% CI, 0.15 to 0.50; log-rank p < 0.001). LMP also significantly reduced the weekly mean pain severity in the double-blind phase of the study (p = 0.007). CONCLUSIONS: LMP produced partial relief of pain symptoms in some patients with TN. For responders, LMP may be used as an add-on therapy in a multidrug treatment protocol.
ABSTRACT
BACKGROUND: Significant race and sex disparities exist in the prevalence, diagnosis, and outcomes of peripheral artery disease (PAD). However, clinical trials evaluating treatments for PAD often lack representative patient populations. This systematic review aims to summarize the demographic representation and enrollment strategies in clinical trials of lower-extremity endovascular interventions for PAD. METHODS: Following the 2020 Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, we searched multiple sources (Medline, EMBASE, Cochrane, Clinicaltrials.gov, WHO clinical trial registry) for randomized controlled trials (RCTs), RCT protocols, and peer-reviewed journal publications of RCTs conducted between January 2012 and December 2022. Descriptive analysis was used to summarize trial characteristics, publication or study protocol characteristics, and the reporting of demographic characteristics. Meta-regression was used to explore associations between demographic characteristics and certain trial characteristics. RESULTS: A total of 2,374 records were identified. Of these, 59 met the inclusion criteria, consisting of 35 trials, 14 publications, and 10 protocols. Information regarding demographic representation was frequently missing. While all 14 trial publications reported age and sex, only 4 reported race/ethnicity, and none reported socioeconomic or marital status. Additionally, only 4 publications reported clinical outcomes by demographic characteristics. Meta-regression analysis revealed that 6% more women were enrolled in non-European trials (36%) than in European trials (30%). CONCLUSIONS: The findings of this review highlight potential issues that may compromise the reliability and external validity of study findings in lower-extremity PAD RCTs when applied to the real-world population. Addressing these issues is crucial to enhance the generalizability and impact of clinical trial results in the field of PAD, ultimately leading to improved clinical outcomes for patients in underrepresented populations. REGISTRATION: The systematic review methodology was published in the International Prospective Register of Systematic Reviews (PROSPERO: CRD42022378304).
Subject(s)
Peripheral Arterial Disease , Randomized Controlled Trials as Topic , Humans , Peripheral Arterial Disease/therapy , Female , MaleABSTRACT
In a prospective observational study (POS) designed to assess the average causal effect of a treatment (e.g. Drug A) compared to a comparator (e.g. Drug B) in the treatment population, enrolling all patients who are assigned to the treatments of interest for follow-up has a potentially large negative impact on the statistical efficiency and bias of the analysis of the outcomes and on the cost of the study. "Up-front matching" is an innovative enrollment method for selecting patients for long-term follow-up among those who have already been assigned to treatment or comparator which uses frequency matching and hence avoids the restrictions of individual matching that other methods have used. To achieve potential statistical and logistical efficiencies in the POS, in up-front matching, a target population is defined based on a retrospective database which then enables selecting populations of patients for follow-up that have desirable statistical properties. In particular, the resulting populations of patients who are enrolled look like the population of treatment patients were randomized to treatment or comparator for the baseline covariates that are used to select patients for follow-up. The method is illustrated in detail for a study designed to assess the effect of injectable antipsychotics versus oral antipsychotics.
ABSTRACT
BACKGROUND: Universal Health Coverage has been openly recognized in the United Nations health-related Sustainable Development Goals by 2030, though missing under the Millennium Development Goals. Ghana implemented the National Health Insurance Scheme programme in 2004 to improve financial access to healthcare for its citizens. This programme targeting low-income individuals and households includes an Exempt policy for older persons and indigents. Despite population ageing, evidence of the participation and perceptions of older persons in the scheme in cash grant communities is unknown. Hence, this paper examined the prevalence, perceptions and factors associated with health insurance enrollment among older persons in cash grant communities in Ghana. METHODS: Data were from a cross-sectional household survey of 400 older persons(60 + years) and eight FGDs between 2017 and 2018. For the survey, stratified and simple random sampling techniques were utilised in selecting participants. Purposive and stratified sampling techniques were employed in selecting the focus group discussion participants. Data analyses included descriptive, modified Poisson regression approach tested at a p-value of 0.05 and thematic analysis. Stata and Atlas-ti software were used in data management and analyses. RESULTS: The mean age was 73.7 years. 59.3% were females, 56.5% resided in rural communities, while 34.5% had no formal education. Two-thirds were into agriculture. Three-fourth had non-communicable diseases. Health insurance coverage was 60%, and mainly achieved as Exempt by age. Being a female [Adjusted Prevalence Ratio (APR) 1.29, 95%CI:1.00-1.67], having self-rated health status as bad [APR = 1.34, 95%CI:1.09-1.64] and hospital healthcare utilisation [APR = 1.49, 95%CI:1.28-1.75] were positively significantly associated with health insurance enrollment respectively. Occupation in Agriculture reduced insurance enrollment by 20.0%. Cited reasons for poor perceptions of the scheme included technological challenges and unsatisfactory services. CONCLUSION: Health insurance enrollment among older persons in cash grant communities is still not universal. Addressing identified challenges and integrating the views of older persons into the programme have positive implications for securing universal health coverage by 2030.
Subject(s)
Insurance, Health , Humans , Ghana/epidemiology , Female , Cross-Sectional Studies , Male , Aged , Middle Aged , Aged, 80 and over , Prevalence , Universal Health Insurance/economics , Health Services Accessibility , National Health Programs/economicsABSTRACT
BACKGROUND: Female informal caregivers of older adults experience a higher burden of physical and mental health problems compared to their male counterparts due to the greater intensity of care they provide. This is likely to result in an imbalance in health needs, including health insurance enrollment, between male and female informal caregivers of older adults. However, to date, no study is available on the role of gender in health insurance enrollment among informal caregivers of older adults in Ghana. This study examines the association between gender and health insurance enrollment among informal caregivers of older adults in Ghana. METHODS: Cross-sectional data from the Informal Caregiving, Health, and Healthcare Survey among caregivers of older adults aged 50 years or above (N = 1,853 and mean ages = 39.15 years and 75.08 years of informal caregivers and their care recipients, respectively) in Ghana were analyzed. A binary logit regression model was used to estimate the association between gender and health insurance enrollment. All statistical inferences were made at the 5% significance level. RESULTS: The final Model (3) showed that female informal caregivers were 2.70 times significantly more likely to enrol in a health insurance scheme than their male counterparts (AOR: 2.70, 95% CI: 2.09-3.48, p-value = 0.001). Apart from gender, the results revealed that participants aged 55-64 years (AOR = 2.38, 95%CI: 1.29-4.41, p-value = 0.006), with tertiary education (AOR: 3.62, 95% CI: 2.32-5.66, p-value = 0.001) and living with the care recipients (AOR: 1.50, 95% CI: 1.14-1.98, p-value = 0.003) were significantly more likely to enrol in a health insurance scheme than their counterparts. The findings further showed that those who earned between GH¢1000 and 1999 (US$99.50-198.50) monthly (AOR: 0.70, 95% CI: 0.52-0.95, p-value = 0.022) and were affiliated with African traditional religion (AOR: 0.30, 95%CI: 0.09-0.99, p-value = 0.048) were significantly less likely to enrol in a health insurance scheme than their counterparts. CONCLUSION: Gender was a significant predictor of health insurance enrollment among informal caregivers of older adults. This finding contributes to the empirical debates on the role of gender in health insurance enrollment among informal caregivers of older adults. Policymakers need to develop gender-specific measures to address gender gaps in health insurance enrollment among informal caregivers of older adults in Ghana. Such health policies and programs should consider other significant demographic and socioeconomic factors associated with health insurance enrolment among informal caregivers of older adults in Ghana.
Subject(s)
Caregivers , Insurance, Health , Humans , Ghana , Female , Male , Caregivers/statistics & numerical data , Caregivers/psychology , Middle Aged , Aged , Cross-Sectional Studies , Insurance, Health/statistics & numerical data , Adult , Sex Factors , Health Care Surveys , Aged, 80 and overABSTRACT
Clinical researchers should help respect the autonomy and promote the well-being of prospective study participants by helping them make voluntary, informed decisions about enrollment. However, participants often exhibit poor understanding of important information about clinical research. Bioethicists have given special attention to "misconceptions" about clinical research that can compromise participants' decision-making, most notably the "therapeutic misconception." These misconceptions typically involve false beliefs about a study's purpose, or risks or potential benefits for participants. In this article, we describe a misconception involving false beliefs about a study's potential benefits for non-participants, or its expected social value. This social value misconception can compromise altruistically motivated participants' decision-making, potentially threatening their autonomy and well-being. We show how the social value misconception raises ethical concerns for inherently low-value research, hyped research, and even ordinary research, and advocate for empirical and normative work to help understand and counteract this misconception's potential negative impacts on participants.
ABSTRACT
BACKGROUND: Although the Ethiopian government has implemented a community-based health insurance (CBHI) program, community enrollment and clients' satisfaction have not been well investigated in Gondar Zuria district, Northwest Ethiopia. This study assessed CBHI scheme enrollment, clients' satisfaction, and associated factors among households in the district. METHODS: A community-based cross-sectional survey assessed CBHI scheme enrollment and clients' satisfaction among households in Gondar Zuria district, Northwest Ethiopia, from May to June 2022. A systematic random sampling method was used to select the study participants from eligible households. A home-to-home interview using a structured questionnaire was conducted. Data were analysed using the statistical packages for social sciences version 26. Logistic regression was used to identify variables associated with enrollment and clients' satisfaction. A p-value < 0.05 was considered statistically significant. RESULTS: Out of 410 participants, around two-thirds (64.9%) of the participants were enrolled in the CBHI scheme. Residency status (AOR = 1.38, 95% CI: 1.02-5.32; p = 0.038), time taken to reach a health facility (AOR = 1.01, 95% CI: 1.00-1.02; p = 0.001), and household size (AOR = 0.77, 95% CI: 0.67-0.88; p < 0.001) were significantly associated with CBHI scheme enrollment. Two-thirds (66.5%) of enrolled households were dissatisfied with the overall services provided; in particular, higher proportions were dissatisfied with the availability of medication and laboratory tests (88.7%). Household size (AOR = 1.31, 95% CI: 1.01-2.24; p = 0.043) and waiting time to get healthcare services (AOR = 3.14, 95% CI: 1.01-9.97; p = 0.047) were predictors of clients' satisfaction with the CBHI scheme services. CONCLUSION: Although a promisingly high proportion of households were enrolled in the CBHI scheme, most of them were dissatisfied with the service. Improving waiting times to get health services, improving the availability of medications and laboratory tests, and other factors should be encouraged.
Subject(s)
Community-Based Health Insurance , Humans , Insurance, Health , Ethiopia , Cross-Sectional Studies , Surveys and Questionnaires , Personal SatisfactionABSTRACT
BACKGROUND: To elucidate the sociodemographic and study factors involved in enrollment in the Traumatic Brain Injury Model System (TBIMS) database, this study examined the effect of a variety of variables on enrollment at a local TBIMS center. METHODS: A sample of 654 individuals from the local TBIMS center was studied examining enrollment by age, gender, race, ethnicity, homelessness status at date of injury, history of homelessness, health insurance status, presence of social support, primary language, consenting in hospital or after discharge, and the need for an interpreter. Binary logistic regression was conducted to identify variables that predict center-based enrollment into TBIMS. RESULTS: Results demonstrated that older age was associated with decreasing enrollment (OR = 0.99, p = 0.01), needing an interpreter made enrollment less likely (OR = 0.33, p < 0.01), being primarily Spanish speaking predicted enrollment (OR = 3.20, p = 0.02), Hispanic ethnicity predicted enrollment (OR = 7.31, p = 0.03), and approaching individuals in the hospital predicted enrollment (OR = 6.94, p < 0.01). Here, OR denotes the odds ratio estimate from a logistic regression model and P denotes the corresponding p-value. CONCLUSIONS: These results can be useful in driving enrollment strategies at this center for other similar TBI research, and to contribute a representative TBI sample to the national database.
Subject(s)
Brain Injuries, Traumatic , Humans , New York City/epidemiology , Brain Injuries, Traumatic/epidemiology , EthnicityABSTRACT
BACKGROUND: Social media platforms are increasingly used to recruit patients for clinical studies. Yet, patients' attitudes regarding social media recruitment are underexplored. OBJECTIVE: This mixed methods study aims to assess predictors of the acceptance of social media recruitment among patients with hepatitis B, a patient population that is considered particularly vulnerable in this context. METHODS: Using a mixed methods approach, the hypotheses for our survey were developed based on a qualitative interview study with 6 patients with hepatitis B and 30 multidisciplinary experts. Thematic analysis was applied to qualitative interview analysis. For the cross-sectional survey, we additionally recruited 195 patients with hepatitis B from 3 clinical centers in Germany. Adult patients capable of judgment with a hepatitis B diagnosis who understood German and visited 1 of the 3 study centers during the data collection period were eligible to participate. Data analysis was conducted using SPSS (version 28; IBM Corp), including descriptive statistics and regression analysis. RESULTS: On the basis of the qualitative interview analysis, we hypothesized that 6 factors were associated with acceptance of social media recruitment: using social media in the context of hepatitis B (hypothesis 1), digital literacy (hypothesis 2), interest in clinical studies (hypothesis 3), trust in nonmedical (hypothesis 4a) and medical (hypothesis 4b) information sources, perceiving the hepatitis B diagnosis as a secret (hypothesis 5a), attitudes toward data privacy in the social media context (hypothesis 5b), and perceived stigma (hypothesis 6). Regression analysis revealed that the higher the social media use for hepatitis B (hypothesis 1), the higher the interest in clinical studies (hypothesis 3), the more trust in nonmedical information sources (hypothesis 4a), and the less secrecy around a hepatitis B diagnosis (hypothesis 5a), the higher the acceptance of social media as a recruitment tool for clinical hepatitis B studies. CONCLUSIONS: This mixed methods study provides the first quantitative insights into social media acceptance for clinical study recruitment among patients with hepatitis B. The study was limited to patients with hepatitis B in Germany but sets out to be a reference point for future studies assessing the attitudes toward and acceptance of social media recruitment for clinical studies. Such empirical inquiries can facilitate the work of researchers designing clinical studies as well as ethics review boards in balancing the risks and benefits of social media recruitment in a context-specific manner.
Subject(s)
Hepatitis B , Patient Selection , Social Media , Humans , Hepatitis B/psychology , Female , Male , Adult , Cross-Sectional Studies , Middle Aged , GermanyABSTRACT
BACKGROUND: The aim of this study was to examine the racial and ethnic representation in studies included in the 2015 American Academy of Orthopaedic Surgeons Surgical Management of the Knee Evidence-Based Clinical Practice Guideline relative to their representation of the United States (US). METHODS: The demographic characteristics reported in articles included in the 2015 American Academy of Orthopaedic Surgeons Surgical Management of the Knee Evidence-Based Clinical Practice Guideline were analyzed. The primary outcome of interest was the representation quotient, which is the ratio of the proportion of a racial/ethnic group in the guideline studies relative to their proportion in the US. There were 211 studies included, of which 15 (7%) reported race. There were 35 studies based in the US and 7 of the US-based studies reported race. RESULTS: No US-based studies reported race and ethnicity separately, no studies reported American Indian/Alaska Native participants and no US-based studies reported Asian participants. The representation quotient of US-based studies was 0.66 for Black participants, 0.33 for Hispanic participants, and 1.30 for White participants, which indicates a relative over-representation of White participants compared to national proportions. CONCLUSION: This study illustrated that the evidence base for the surgical management of knee osteoarthritis has been constructed from studies which fail to consider race and ethnicity. Of those US-based studies which do report race or ethnicity, study cohorts do not reflect the US population. These results illustrate a disparity in clinical orthopedic surgical evidence and highlight the need for improved research recruitment strategies.
Subject(s)
Ethnicity , Orthopedic Surgeons , Osteoarthritis, Knee , Racial Groups , Humans , Knee Joint , Osteoarthritis, Knee/surgery , United States , Practice Guidelines as TopicABSTRACT
An accurate forecast of a clinical trial enrollment timeline at the planning phase is of great importance to both corporate strategic planning and trial operational excellence. The naive approach often calculates an average enrollment rate from historical data and generates an inaccurate prediction based on a linear trend with the average rate. Under the traditional framework of a Poisson-Gamma model, site activation delays are often modeled with either fixed initiation time or a simple random distribution while incorporating the user-provided site planning information to achieve good forecast accuracy. However, such user-provided information is not available at the early portfolio planning stage. We present a novel statistical approach based on generalized linear mixed-effects models and the use of non-homogeneous Poisson processes through the Bayesian framework to model the country initiation, site activation, and subject enrollment sequentially in a systematic fashion. We validate the performance of our proposed enrollment modeling framework based on a set of 25 preselected studies from four therapeutic areas. Our modeling framework shows a substantial improvement in prediction accuracy in comparison to the traditional statistical approach. Furthermore, we show that our modeling and simulation approach calibrates the data variability appropriately and gives correct coverage rates for prediction intervals of various nominal levels. Finally, we demonstrate the use of our approach to generate the predicted enrollment curves through time with confidence bands overlaid.
Subject(s)
Models, Statistical , Humans , Bayes Theorem , Computer Simulation , Linear ModelsABSTRACT
OBJECTIVES: This review aims to reinforce the importance of improving sex balance in preclinical trials and sex and gender diversity and proportional balance in clinical trials enrollment and how this influences interpretation of stroke clinical trials. It also aims to identify strategies for improvement in data collection. MATERIALS AND METHODS: A PubMed search was conducted of publications in English, using MeSH terms sex, sex characteristics, gender identity, transgender, gender-nonconforming persons, clinical trials as topic, stroke. Of 249 search results, 217 were human or animal studies related to stroke, the majority of which were reviews, secondary analyses of stroke clinical trials, meta analyses, or retrospective studies, subject to the methods of sex and gender acquisition per the primary data source. Articles were reviewed, noting inclusion or absence of sex and gender definitions and trial design. Selected articles were supplemented with United States Food and Drug Administration, National Institutes of Health, and National Academy of Science, Engineering, and Medicine publications. RESULTS: The majority of preclinical studies continue to report sex as a binary variable, and the majority of stroke clinical trials report sex and gender as interchangeable and binary. Mindful trial design and statistical analysis can improve accuracy in the interpretation of sex and gender differences. Guidance exists to improve reporting on currently accepted sex and gender definitions, recommended data collection instruments, and appropriate statistical analyses. CONCLUSIONS: Despite acknowledgement of having failed to achieve diverse and proportionally balanced enrollment, sex and gender imbalance across the research continuum remains prevalent. Responsible incorporation of sex and gender in stroke clinical trials can be achieved through thoughtful study design, use of contemporary sex and gender definitions, inclusive prospective data collection, balanced enrollment with prespecified goals, and appropriate statistical analysis.
Subject(s)
Clinical Trials as Topic , Patient Selection , Stroke , Humans , Male , Female , Stroke/therapy , Stroke/diagnosis , Stroke/physiopathology , Sex Factors , Animals , Health Status Disparities , Research Design , Data Interpretation, Statistical , Healthcare Disparities , Research Subjects , Gender Identity , Risk FactorsABSTRACT
Although many scholars have written about culture in schools and discuss culture as a group-level phenomenon, quantitative studies tend to empirically examine culture at the individual-level. This study presents a group-level conceptualization of academic culture known as cultural heterogeneity-the presence of a diverse array of competing and conflicting cultural models-to examine whether variation in school-level academic orientation predicts college enrollment. We use the Educational Longitudinal Study of 2002 (ELS) to show that whereas academic press (or average school academic culture) is positively related to enrollment, variation in school academic culture is associated with declines in enrollment. These findings hold net of students' own academic behaviors and beliefs, background factors, and school characteristics. Thus, exposure to conflicting models of culture can lead youth to make decisions that do not reflect broader societal goals. This study addresses the misalignment between the conceptual and empirical definitions of culture in education by examining the link between school academic culture measured as a group-level process, which is consistent with how scholars discuss culture, and college enrollment.