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The Implementation Outcomes and Population Impact of a Statewide IT Deployment for Family Caregivers: Mixed Methods Study.
JMIR Aging
December 2024
Family Caregiver Alliance, San Franciscio, CA, United States.
Background: In 2022, the US Department of Health and Human Services released the first National Strategy to Support Family Caregivers, identifying actions for both government and the private sector. One of the major goals is to expand data, research, and evidence-based practices to support family caregivers. While IT tools are widely deployed in health care settings, they are rarely available at scale in community agencies.
View Article and Find Full Text PDFApplying the estimand framework to clinical pharmacology trials with a case study in bioequivalence.
Br J Clin Pharmacol
November 2024
Statistical Innovation, Respiratory and Immunology Biometrics and Statistical Innovation, Biopharmaceuticals R&D, AstraZeneca, Cambridge, UK.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use has published an addendum on estimands and sensitivity analysis in clinical trials along with related training materials. These define an estimand as a precise description of the treatment effect that reflects the scientific question of interest. In December 2022, the US Food and Drug Administration released draft guidance recommending estimands of interest be specified in bioequivalence trial protocols.
View Article and Find Full Text PDF"It's Like Making Reflective Practice More of the Heart of Who We Are": An Exploration of Facilitators and Barriers to Implementing Reflective Supervision in State Pre-K.
Prev Sci
December 2024
Department of Psychiatry and Human Behavior, The Warren Alpert Medical School of Brown University, Providence, RI, USA.
High-quality supervision for teachers in early care and education (ECE) is essential for building positive teacher-child relationships and enhancing ECE program quality, which in turn promotes healthy social-emotional and academic development in young children. Reflective supervision (RS) is a process-oriented and relationship-centered supervisory approach that has growing empirical evidence supporting its use. As the evidence base for RS continues to expand, and early childhood-serving settings-including ECE-increasingly consider this approach, understanding whether RS is likely to be routinely used in ECE settings and what helps or hinders use of this approach is critically important.
View Article and Find Full Text PDFApplication of the estimand framework for an emulated trial using reference based multiple imputation to investigate informative censoring.
BMC Med Res Methodol
October 2024
Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, UK.
Background: The ICH E9 (R1) addendum on Estimands and Sensitivity analysis in Clinical trials proposes a framework for the design and analysis of clinical trials aimed at improving clarity around the definition of the targeted treatment effect (the estimand) of a study.
Methods: We adopt the estimand framework in the context of a study using "trial emulation" to estimate the risk of pneumocystis pneumonia, an opportunistic disease contracted by people living with HIV and AIDS having a weakened immune system, when considering two antibiotic treatment regimes for stopping antibiotic prophylaxis treatment against this disease. A "while on treatment" strategy has been implemented for post-randomisation (intercurrent) events.
Improvement of the gait deviation index for spinal cord injury to broaden its applicability: the reduced gait deviation index for spinal cord injury (rSCI-GDI).
Front Bioeng Biotechnol
October 2024
Department of Applied Mathematics, School of Science and Technology, Materials Science and Engineering and Electronic Technology, Rey Juan Carlos University, Móstoles, Madrid, Spain.
Background: The SCI-GDI is an accurate and effective metric to summarize gait kinematics in adults with SCI. It is usually computed with the information registered with a photogrammetry system because it requires accurate information of pelvic and hip movement in the three anatomic planes, which is hard to record with simpler systems. Additionally, due to being developed from the GDI, the SCI-GDI is built upon nine joint movements selected for a pediatric population with cerebral palsy, for which the GDI was originally developed, but those nine movements are not necessarily as meaningful for adults with SCI.
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