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New technologies and disruptions related to Coronavirus disease-2019 have led to expansion of decentralized approaches to clinical trials. Remote tools and methods hold promise for increasing trial efficiency and reducing burdens and barriers by facilitating participation outside of traditional clinical settings and taking studies directly to participants. The Trial Innovation Network, established in 2016 by the National Center for Advancing Clinical and Translational Science to address critical roadblocks in clinical research and accelerate the translational research process, has consulted on over 400 research study proposals to date. Its recommendations for decentralized approaches have included eConsent, participant-informed study design, remote intervention, study task reminders, social media recruitment, and return of results for participants. Some clinical trial elements have worked well when decentralized, while others, including remote recruitment and patient monitoring, need further refinement and assessment to determine their value. Partially decentralized, or “hybrid” trials, offer a first step to optimizing remote methods. Decentralized processes demonstrate potential to improve urban-rural diversity, but their impact on inclusion of racially and ethnically marginalized populations requires further study. To optimize inclusive participation in decentralized clinical trials, efforts must be made to build trust among marginalized communities, and to ensure access to remote technology.
Racially and ethnically minoritized populations have been historically excluded and underrepresented in research. This paper will describe best practices in multicultural and multilingual awareness-raising strategies used by the Recruitment Innovation Center to increase minoritized enrollment into clinical trials. The Passive Immunity Trial for Our Nation will be used as a primary example to highlight real-world application of these methods to raise awareness, engage community partners, and recruit diverse study participants.
Story memory tasks are among the most commonly used memory tests; however, research suggests they may be less sensitive to memory decline and have a weaker association with hippocampal volumes than list learning tasks. To examine its utility, we compared story memory to other memory tests on impairment rates and association with hippocampal volumes.
Archival records from 1617 older adults (Mage = 74.41, range = 65–93) who completed the Wechsler Memory Scale – 4th edition (WMS-IV) Logical Memory (LM), Hopkins Verbal Learning Test – Revised (HVLT-R), and Brief Visuospatial Memory Test – Revised (BVMT-R) as part of a clinical neuropsychological evaluation were reviewed. Scores >1.5 SD below age-adjusted means were considered impaired, and frequency distributions were used to examine impairment rates. A subset of participants (n = 179) had magnetic resonance imaging (MRI) data that underwent image quality assessment. Partial correlations and linear regression analyses, accounting for age, education, and total intracranial volume (TIV), examined associations between memory raw scores and hippocampal volumes.
For delayed recall, nearly half of the sample was impaired on HVLT-R (48.8%) and BVMT-R (46.1%), whereas a little more than a third was impaired on LM (35.7%). Better performance on all three measures was related to larger hippocampal volumes (r’s =. 26–.43, p’s < .001). Individually adding memory scores to regression models predicting hippocampal volumes improved the model fit for all measures.
Despite findings suggesting that story memory is less sensitive to memory dysfunction, it was not differentially associated with hippocampal volumes compared to other memory measures. Results support assessing memory using different formats and modalities in older adults.
Background: Psychological therapy services are often required to demonstrate their effectiveness and are implementing systematic monitoring of patient progress. A system for measuring patient progress might usefully ‘inform supervision’ and help patients who are not progressing in therapy. Aims: To examine if continuous monitoring of patient progress through the supervision process was more effective in improving patient outcomes compared with giving feedback to therapists alone in routine NHS psychological therapy. Method: Using a stepped wedge randomized controlled design, continuous feedback on patient progress during therapy was given either to the therapist and supervisor to be discussed in clinical supervison (MeMOS condition) or only given to the therapist (S-Sup condition). If a patient failed to progress in the MeMOS condition, an alert was triggered and sent to both the therapist and supervisor. Outcome measures were completed at beginning of therapy, end of therapy and at 6-month follow-up and session-by-session ratings. Results: No differences in clinical outcomes of patients were found between MeMOS and S-Sup conditions. Patients in the MeMOS condition were rated as improving less, and more ill. They received fewer therapy sessions. Conclusions: Most patients failed to improve in therapy at some point. Patients’ recovery was not affected by feeding back outcomes into the supervision process. Therapists rated patients in the S-Sup condition as improving more and being less ill than patients in MeMOS. Those patients in MeMOS had more complex problems.
The SEARCH Nutrition Ancillary Study aims to investigate the role of dietary intake on the development of long-term complications of type 1 diabetes in youth, and capitalise on measurement error (ME) adjustment methodology. Using the National Cancer Institute (NCI) method for episodically consumed foods, we evaluated the relationship between sugar-sweetened beverage (SSB) intake and cardiovascular risk factor profile, with the application of ME adjustment methodology. The calibration sample included 166 youth with two FFQ and three 24 h dietary recall data within 1 month. The full sample included 2286 youth with type 1 diabetes. SSB intake was significantly associated with higher TAG, total and LDL-cholesterol concentrations, after adjusting for energy, age, diabetes duration, race/ethnicity, sex and education. The estimated effect size was larger (model coefficients increased approximately 3-fold) after the application of the NCI method than without adjustment for ME. Compared with individuals consuming one serving of SSB every 2 weeks, those who consumed one serving of SSB every 2 d had 3·7 mg/dl (0·04 mmol/l) higher TAG concentrations and 4·0 mg/dl (0·10 mmol/l) higher total cholesterol and LDL-cholesterol concentrations, after adjusting for ME and covariates. SSB intake was not associated with measures of adiposity and blood pressure. Our findings suggest that SSB intake is significantly related to increased lipid levels in youth with type 1 diabetes, and that estimates of the effect size of SSB on lipid levels are severely attenuated in the presence of ME. Future studies in youth with diabetes should consider a design that will allow for the adjustment for ME when studying the influence of diet on health status.
To evaluate the relative validity and reliability of the SEARCH FFQ that was modified from the Block Kids Questionnaire.
Study participants completed the eighty-five-item FFQ twice plus three 24 h dietary recalls within one month. We estimated correlations between frequencies obtained from participants with the true usual intake for food groups and nutrients, using a two-part model for episodically consumed foods and measurement error adjustment.
The multi-centre SEARCH for Diabetes in Youth Nutrition Ancillary Study.
A subgroup of 172 participants aged 10–24 years with type 1 diabetes.
The mean correlations, adjusted for measurement error, of food groups and nutrients between the FFQ and true usual intake were 0·41 and 0·38, respectively, with 57 % of food groups and 70 % of nutrients exhibiting correlations >0·35. Correlations were high for low-fat dairy (0·80), sugar-sweetened beverages (0·54), cholesterol (0·59) and saturated fat (0·51), while correlations were poor for high-fibre bread and cereal (0·16) and folate (0·11). Reliability of FFQ intake based on two FFQ administrations was also reasonable, with 54 % of Pearson correlation coefficients ≥0·5. Reliability was high for low-fat dairy (0·7), vegetables (0·6), carbohydrates, fibre, folate and vitamin C (all 0·5), but less than desirable for low-fat poultry and high-fibre bread, cereal, rice and pasta (0·2–0·3).
While there is some room for improvement, our findings suggest that the SEARCH FFQ performs quite well for the assessment of many nutrients and food groups in a sample of youth with type 1 diabetes.
This paper describes the extension of a
recently developed numerical solver for the Landau-Lifshitz
Navier-Stokes (LLNS) equations to binary mixtures in three
dimensions. The LLNS equations incorporate thermal fluctuations into
macroscopic hydrodynamics by using white-noise fluxes. These
stochastic PDEs are more complicated in three dimensions due to the
tensorial form of the correlations for the stochastic fluxes and in
mixtures due to couplings of energy and concentration fluxes (e.g.,
Soret effect). We present various numerical tests of systems in and
out of equilibrium, including time-dependent systems, and
demonstrate good agreement with theoretical results and molecular