Predicting amyloid status using self?report information from an online research and recruitment registry: The Brain Health Registry
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ABSTRACT:
SUBMITTER: Ashford M
PROVIDER: S-EPMC7513627 | biostudies-literature | 2020 Jan
REPOSITORIES: biostudies-literature
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Project description:BackgroundThe TREATgermany registry collects data from children, adolescents, and adults with moderate-to-severe atopic dermatitis (AD) in Germany. For this purpose, clinical and patient-reported outcomes, the course of the disease, and applied therapies are observed.MethodsTREATgermany recruits patients with moderate-to-severe AD according to the diagnostic criteria of the UK Working Party, an "Objective Scoring for Atopic Dermatitis" (oSCORAD) > 20 and/or currently antiinflammatory systemic treatment for AD or previous anti-inflammatory systemic treatment for AD within past 24 months before inclusion. No study related interventions will be performed. Currently, 59 dermatological practices, clinics, and university hospitals are participating in TREATgermany (as of May 2021). Based on the interim analysis of October 13, 2020, patient characteristics were described from 4,373 documented visits of adult participants (n = 1,025).ResultsThe mean age at inclusion in TREATgermany was 42 years, 57.7% of patients were men (n = 591) and 42.3% were women (n = 434). According to oSCORAD, 85.8% of those included suffered from moderate-to-severe AD. At baseline visit, 744 patients had already received one or more systemic treatments for AD (glucocorticosteroids n = 600, ciclosporin A (CSA) n = 307, dupilumab n = 98). 597 patients received dupilumab during their participation in TREATgermany, 134 patients received CSA.ConclusionWith the increasing number of recruitment centers (October 2020: 38 centers; May 2021: 59 centers), TREATgermany can continue to make an important contribution to health services research for patients with moderate-to-severe AD. The registry fulfills the methodological requirements of IQWiG for the collection and processing of healthcare-related data. With the successful and expected approval of further systemic treatments, these can be compared in terms of efficacy and safety in the future. In addition, with the recruitment of children and adolescents started in 2021, this patient group can also be observed.
| S-EPMC8439109 | biostudies-literature
Project description:OBJECTIVE:To assess the quality of information available online for abortion self-referral and to determine whether quality varies by region or distance to an abortion provider. METHODS:This was a cross-sectional study. We used a standard protocol to perform internet searches from August 2016 to June 2017 for abortion services in the 25 most populous U.S. cities and the 43 state capitals that were not one of the 25 most populous cities. We classified the first 10 webpage results and the first five map results and advertisements as facilitating abortion referral (local independent abortion provider, local Planned Parenthood facility, national abortion provider or organization, prochoice website, or abortion directory), not facilitating abortion referral (nonproviding physician office, nonmedical website, abortion provider greater than 50 miles from the location, news article, general directory, other), or hindering abortion referral (crisis pregnancy center or antichoice website). We used U.S. Census Bureau subregions to examine geographic differences. We made comparisons using a ? test. RESULTS:Overall, from 612 searches from 68 cities, 52.9% of webpage results, 67.3% of map results, and 34.4% of advertisements facilitated abortion referral, whereas 12.9%, 21.7%, and 29.9%, respectively, hindered abortion referral. The content of the searches differed significantly based on U.S. Census Bureau subregion (all P?.001) and distance to an abortion provider (all P?.02). CONCLUSION:Two thirds of map results facilitated abortion self-referral, whereas only half of webpage results did so. Advertisements were the least likely to facilitate and the most likely to hinder self-referral. Quality was lowest in areas that were farthest from abortion providers.
| S-EPMC6249052 | biostudies-literature
Project description:BackgroundScreening to identify individuals with elevated brain amyloid (Aβ+) for clinical trials in Preclinical Alzheimer's Disease (PAD), such as the Anti-Amyloid Treatment in Asymptomatic Alzheimer's disease (A4) trial, is slow and costly. The Trial-Ready Cohort in Preclinical/Prodromal Alzheimer's Disease (TRC-PAD) aims to accelerate and reduce costs of AD trial recruitment by maintaining a web-based registry of potential trial participants, and using predictive algorithms to assess their likelihood of suitability for PAD trials.ObjectivesHere we describe how algorithms used to predict amyloid burden within TRC-PAD project were derived using screening data from the A4 trial.DesignWe apply machine learning techniques to predict amyloid positivity. Demographic variables, APOE genotype, and measures of cognition and function are considered as predictors. Model data were derived from the A4 trial.SettingTRC-PAD data are collected from web-based and in-person assessments and are used to predict the risk of elevated amyloid and assess eligibility for AD trials.ParticipantsPre-randomization, cross-sectional data from the ongoing A4 trial are used to develop statistical models.MeasurementsModels use a range of cognitive tests and subjective memory assessments, along with demographic variables. Amyloid positivity in A4 was confirmed using positron emission tomography (PET).ResultsThe A4 trial screened N=4,486 participants, of which N=1323 (29%) were classified as Aβ+ (SUVR ≥ 1.15). The Area under the Receiver Operating Characteristic curves for these models ranged from 0.60 (95% CI 0.56 to 0.64) for a web-based battery without APOE to 0.74 (95% CI 0.70 to 0.78) for an in-person battery. The number needed to screen to identify an Aβ+ individual is reduced from 3.39 in A4 to 2.62 in the remote setting without APOE, and 1.61 in the remote setting with APOE.ConclusionsPredictive algorithms in a web-based registry can improve the efficiency of screening in future secondary prevention trials. APOE status contributes most to predictive accuracy with cross-sectional data. Blood-based assays of amyloid will likely improve the prediction of amyloid PET positivity.
| S-EPMC7745538 | biostudies-literature
Project description:IntroductionRemote data collection, including the establishment of online registries, is a novel approach to efficiently identify risk for cognitive decline and Alzheimer's disease (AD) in older adults, with growing evidence for feasibility and validity. Addition of genetic data to online registries has the potential to facilitate identification of older adults at risk and to advance the understanding of genetic contributions to AD.Methods573 older adult participants with longitudinal online Brain Health Registry (BHR) data underwent apolipoprotein E (APOE) genotyping using remotely collected saliva samples and a novel, automated Biofluid Collection Management Portal. We evaluated acceptability of genetic sample collection and estimated associations between (1) sociodemographic variables and willingness to participate in genetics research and (2) APOE results and online cognitive and functional assessments. We also assessed acceptance of hypothetical genetics research participation by surveying a larger sample of 25,888 BHR participants.Results51% of invited participants enrolled in the BHR genetics study, BHR-GenePool Study (BHR-GPS); 27% of participants had at least one APOE ε4 allele. Older participants and those with higher educational attainment were more likely to participate. In the remotely administered Cogstate Brief Battery, APOE ε4/ε4 homozygotes (HM) had worse online learning scores, and greater decline in processing speed and attention, compared to ε3/ε4 heterozygotes (HT) and ε4 non-carriers (NC).DiscussionAPOE genotyping of more than 500 older adults enrolled in BHR supports the feasibility and validity of a novel, remote biofluids collection approach from a large cohort of older adults, with data linkage to longitudinal online cognitive data. This approach can be expanded for efficient collection of genetic data and other information from biofluids in the future.
| S-EPMC7882536 | biostudies-literature
Project description:ObjectiveTo apply practice-based evidence to clinical management of cerebral palsy (CP). The process of establishing purpose, structure, logistics, and elements of a multi-institutional registry and the baseline characteristics of initial enrollees are reported.DesignA consensus-building process among consumers, clinicians, and researchers used a participatory action process.SettingCommunity, hospitals, and universities.ParticipantsMore than 100 clinicians, researchers, and consumers and more than 1858 enrollees in the registry.Main outcome measuresNot applicable.ResultsConsensus was that the purpose of registry was to (1) quantify practice variation, (2) facilitate quality improvement (QI), and (3) perform comparative effectiveness research (CER). Collecting data during routine clinical care using the electronic medical record was determined to be a sustainable plan for data acquisition and management. Clinicians from multiple disciplines defined salient characteristics of individuals and interventions for the registry elements. The registry was central to the clinical research network, and a leadership structure was created. A leading electronic health record platform adopted the registry elements. Twenty-four sites have initiated the data collection process and agreed to export data to the registry. Currently 12 are collecting data. Number of enrollees and characteristics were similar to other population registers.ConclusionsThis is the first multi-institutional CP registry that contains the patient and treatment characteristics needed for QI and CER. The Cerebral Palsy Research Network registry elements are implemented in a versatile electronic platform and minimize burden to clinicians. The resultant registry is available for any institution to participate and is growing rapidly.
| S-EPMC7853390 | biostudies-literature
Project description:BackgroundThe Coronavirus Disease 2019 (COVID-19) pandemic has had substantial global morbidity and mortality. Clinical research related to prevention, diagnosis, and treatment of COVID-19 is a top priority. Effective and efficient recruitment is challenging even without added constraints of a global pandemic. Recruitment registries offer a potential solution to slow or difficult recruitment.ObjectivesThe purpose of this paper is to describe the design and implementation of a digital research recruitment registry to optimize awareness and participant enrollment for COVID-19-related research in Baltimore and to report preliminary results.MethodsPlanning began in March 2020, and the registry launched in July 2020. The primary recruitment mechanisms include electronic medical record data, postcards distributed at testing sites, and digital advertising campaigns. Following consent in a Research Electronic Data Capture survey, participants answer questions related to COVID-19 exposure, testing, and willingness to participate in research. Branching logic presents participants with studies they might be eligible for.ResultsAs of March 24, 2021, 9010 participants have enrolled, and 64.2% are female, 80.6% are White, 9.4% are Black or African American, and 6% are Hispanic or Latino. Phone outreach has had the highest response rate (13.1%), followed by email (11.9%), text (11.4%), and patient portal message (9.4%). Eleven study teams have utilized the registry, and 4596 matches have been made between study teams and interested volunteers.ConclusionEffective and efficient recruitment strategies are more important now than ever due to the time-limited nature of COVID-19 research. Pilot efforts have been successful in connecting interested participants with recruiting study teams.
| S-EPMC8387691 | biostudies-literature
Project description:With the aim of addressing the relative scarcity of information on youth-onset diabetes in India, the Indian Council of Medical Research (ICMR) decided to establish the Registry of People with Diabetes with Young Age at Onset (YDR) in 2006. The major objectives of YDR are to generate information on disease pattern or types of youth-onset diabetes including their geographical variations within India and to estimate the burden of diabetes complications.YDR is an observational multicenter clinic based registry enlisting physician diagnosed diabetes in individuals below 25 years of age. Diabetes was classified using symptom based clinical criteria. YDR data collection is coordinated through regional collaborating centers and their interacting reporting centers across India. A baseline and an annual follow-up proformas are used to obtain information on sociodemographic details, clinical profile, and anthropometric and laboratory measurements of the patients.In phase 1, the registry has enrolled 5546 patients, in which type 1 diabetes mellitus (T1DM) was the most prevalent (63.9%), followed by youth-onset type 2 diabetes mellitus (T2DM) (25.3%).This registry provides a unique opportunity to study the natural history of youth-onset diabetes in India.
| S-EPMC5032954 | biostudies-literature
Project description:Type 1 diabetes is a multifactorial disease with an early age of onset, in which the insulin producing beta cell of the pancreas are destroyed because of autoimmunity. It is the second most common chronic disease in children and account for 5% to 10% of all diagnosed cases of diabetes. India is having an incidence of 10.6 cases/year/100,000, and recent studies indicate that the prevalence of type 1 diabetes in India is increasing. However in view of poor health care network, there is no monitoring system in the country. Of the 18 genomic intervals implicated for the risk to develop type 1 diabetes, the major histocompatibility complex (MHC) region on chromosome 6p21.31 has been the major contributor estimated to account for 40-50%, followed by 10% frequency of INS-VNTR at 5' flanking region of the insulin gene on chromosome 11p15.5. However, population studies suggest that > 95% of type 1 diabetes have HLA-DR3 or DR4, or both, and in family studies, sibling pairs affected with type 1 diabetes have a non-random distribution of shared HLA haplotypes. As predisposing genetic factors such as HLA alleles are known, immunological interventions to prevent type 1 diabetes are of great interest. In the present study we have reviewed the status of molecular genetics of the disease and the approaches that need to be adopted in terms of developing patient and suitable control cohorts in the country.
| S-EPMC2812756 | biostudies-literature
Project description:IntroductionExisting scholarly curricula often underemphasize basic research skills and do not address the individual learning needs of residents, whose level of prior exposure to research concepts varies widely. A supplemental educational experience was developed to address educational gaps in a family medicine residency curriculum, including systematic exploration and interpretation of the medical literature, development and exploration of clinically pertinent questions, and development of residents' written communication skills.MethodsA 2-week, online, self-directed research curriculum was developed. The five-module curriculum included (I) Research Methods and Data Analysis, (II) Article Review, (III) Board Review, (IV) Literature Search, and (V) Literature Review and Proposal. Two years after implementation, residents who completed the curriculum were surveyed to assess the overall rotation and its success in meeting learning objectives.ResultsEighteen residents completed the new rotation and demonstrated objectives through assignment completion and review. Additionally, residents reported improved skills on all objectives and were satisfied with the new curriculum and its self-led, online format. Those planning to do research after graduation were more likely to report several benefits from the rotation, including learning more about data analyses and being more likely to complete a future scholarly project.DiscussionAn online, self-directed curriculum can provide a feasible and effective educational approach to efficient use of faculty and resident time, allowing time to be focused on resident-specific knowledge gaps and learning needs, rather than presenting all learning material uniformly. The online, accessible format aligned with residents' existing reliance on the internet as a primary information source.
| S-EPMC6346278 | biostudies-literature
Project description:BackgroundMuch of the epidemiologic research on risk factors for fibroids, the leading indication for hysterectomy, relies on self-reported outcome. Self-report is subject to misclassification because many women with fibroids are undiagnosed. The purpose of this analysis was to quantify the extent of misclassification and identify associated factors.MethodsSelf-reported fibroid status was compared to ultrasound screening from 2046 women in Right From The Start (RFTS) and 869 women in the Uterine Fibroid Study (UFS). Log-binomial regression was used to estimate sensitivity (Se) and specificity (Sp) and examine differences by ethnicity, age, education, body mass index, parity, and miscarriage history.ResultsOverall sensitivity was ?0.50. Sensitivity was higher in blacks than whites (RFTS: 0.34 vs. 0.23; UFS: 0.58 vs. 0.32) and increased with age. Parous women had higher sensitivity than nulliparae, especially in RFTS whites (Se ratio=2.90; 95% confidence interval [CI]: 1.51, 5.60). Specificity was 0.98 in RFTS and 0.86 in UFS. Modest ethnic differences were seen in UFS (Sp ratio, black vs. white=0.90; 95% CI: 0.81, 0.99). Parity was inversely associated with specificity, especially among UFS black women (Sp ratio=0.84; 95% CI: 0.73, 0.97). Among women who reported a previous diagnosis, a shorter time interval between diagnosis and ultrasound was associated with increased agreement between the two measures.ConclusionsMisclassification of fibroid status can differ by factors of etiologic interest. These findings are useful for assessing (and correcting) bias in studies using self-reported clinical diagnosis as the outcome measure.
| S-EPMC3298676 | biostudies-literature