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http://dx.doi.org/10.1016/S1473-3099(22)00830-1 | DOI Listing |
Trials
January 2025
Internal Medicine (Rheumatology), Academic Hospital, Istanbul, Turkey.
Background: It was our impression that safety outcome trials were getting more frequent, raising ethical issues mainly related to patient autonomy. We and others had also proposed this autonomy would be best served if wording of the informed consents would be in the public domain.
Methods: Initially two observers and an arbiter tabulated the main aims of randomized controlled trials (RCTs) published in 1990-1991 vs.
J Med Internet Res
January 2025
Department for Prevention and Care of Diabetes, Faculty of Medicine Carl Gustav Carus, Technische Universität Dresden, Dresden, Germany.
Background: Digital technologies for type 2 diabetes mellitus (T2DM) care hold great potential to improve patients' health in the long term. Only a subset of telemedicine offerings are digital interventions that meet the criteria for prescribable digitale Gesundheitsanwendung (digital health apps; DiGAs) in Germany. Digital treatments further provide vast amounts of patient data that are important to generate evidence.
View Article and Find Full Text PDFPrev Med Rep
January 2025
Institute of General Practice, Friedrich-Alexander University Erlangen, Nuernberg, Germany.
Objective: HAPpEN aims to implement and evaluate a holistic general practitioner-centered, interdisciplinary obesity management strategy in rural Germany, focusing on feasibility, health outcomes, and economic benefits.
Methods: HAPpEN is a 12-month, pragmatic single-arm, multicenter trial, informed by a formative survey, and initiated in April 2023 with 98 obese participants (body mass index, BMI ≥ 30 kg/m) in Kulmbach, Germany. The program integrates nutritional counseling, physical activity, and behavior change techniques, including smartphone-based self-monitoring.
Am J Med Qual
January 2025
Improving Health Outcomes, American Medical Association, Chicago, IL.
Randomized clinical trials and clinical practice guidelines recommend the use of self-measured blood pressure (SMBP) to help improve the treatment of patients with hypertension. Many clinicians use SMBP in their practices, but there is significant variability in how SMBP is implemented in their day-to-day practice. This quality improvement study details the pragmatic and real-world approach clinicians and administrators used at 3 sites of the IHA Medical Group, a part of Trinity Healthcare, to implement the American Medical Association (AMA) 7-Step SMBP framework as part of the larger AMA hypertension quality improvement program AMA MAP BP.
View Article and Find Full Text PDFClin Trials
January 2025
Julius Center for Health Sciences and Primary Care, University Medical Center Utrecht, Utrecht, The Netherlands.
Background/aims: Low-intervention clinical trials have been established under the European Union Clinical Trials Regulation (EU 536/2014) which aims to simplify the conduct of clinical trials with authorized medicinal products. There is limited experience with conducting low-intervention trials. Therefore, this study aims to report on experiences and perceived (dis)advantages of low-intervention trials.
View Article and Find Full Text PDFEnter search terms and have AI summaries delivered each week - change queries or unsubscribe any time!