Purpose: AIM-Back is an embedded pragmatic clinical trial (ePCT) with cluster randomization designed to increase access and compare the effectiveness of two different non-pharmacological care pathways for low back pain (LBP) delivered within the Veteran Administration Health Care System (VAHCS). This manuscript describes baseline characteristics of AIM-Back participants as well as the representativeness of those referred to the AIM-Back program by sex, age, race, and ethnicity, relative to Veterans with low back pain at participating clinics.
Participants: To be eligible for AIM-Back, Veterans were referred to the randomized pathway at their clinic by trained primary care providers (Referral cohort).
Background: The Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) statement has improved the quality of reporting of randomised trial protocols. Extensions to the SPIRIT statement are needed to address specific issues of trial protocol reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in protocols of clinical trials of implantable neurostimulation devices are common.
View Article and Find Full Text PDFBackground: The Consolidated Standards of Reporting Trials (CONSORT) statement has improved the quality of reporting of randomised trials. Extensions to the CONSORT statement are often needed to address specific issues of trial reporting, including those relevant to particular types of interventions. Methodological and reporting deficiencies in clinical trials of implantable neurostimulation devices are common.
View Article and Find Full Text PDFContemp Clin Trials
January 2025
Older adults with Alzheimer's disease (AD), in addition to significant cognitive disability, have twice the risk of fracture compared to those with normal cognition. Fractures among older adults with AD are associated with substantial morbidity, loss of physical function, and significant mortality. Prior studies have shown a decreased risk of fracture among those taking acetylcholinesterase inhibitors, such as donepezil.
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