The PMD Foundation’s Post

RWD studies can be tricky! In response to our paper comparing weight changes for semaglutide and tirzepatide labeled for T2D, we received questions and criticisms about not including dose comparisons. Dose is undoubtedly impactful to weight change, but time-varying, response-based doses in non-randomized RWD have the potential to introduce bias. More thoughts in JAMA IM: https://lnkd.in/gmdpeZPG

Truveta Research et al recently co-authored a study published in JAMA Internal Medicine on the comparative effectiveness between tirzepatide and semaglutide for weight loss, which has been the most-viewed study on JAMA IM since its publication in early July. Another set of researchers responded to the study with questions on methodology - namely related to the lack of dosage comparisons. Study co-authors from Truveta Research, Nick Stucky and Tricia Rodriguez, PhD, MPH, along with Providence Medical Director Ty J. Gluckman, FACC, FAHA, penned a response to the inquiry, in a letter that was published today in JAMA IM. Flip through the document for a summary of their response, or view the full letter here: https://tr.vet/3Znbxyp Learn more about the study here: https://tr.vet/3XVCPeS

Intraoral Sialadenoma Papilliferum: A Comprehensive Review of the Literature with Emphasis on Clinical and Histopathological Diagnostic Features https://lnkd.in/dWVw2kgi

Happy to share our recent publication, “A Systematic Review on Randomized Clinical Trials for Direct Oral Anticoagulant in Subjects with Acute Coronary Syndrome: Primary and Secondary Outcomes”. I would also like to express my gratitude to the research team members for their contributions. Read the full paper here [ https://lnkd.in/egNEkHPH ]

LIFE-BTK Further Analysis; 12-Month RESOLV Data Ramon Varcoe, MBBS, PhD, discusses his AMP 2024 presentations on the results and indications of the LIFE-BTK (assessing the safety and effectiveness of Abbott's Esprit BTK scaffold) and RESOLV (FIH evaluation of the Magnitude thin-strut 98-μm drug-eluting bioresorbable scaffold from R3 Vascular) studies. https://okt.to/GoIvlK

Learn about this research project by South Australian Health and Medical Research Institute (SAHMRI). It aims to better understand the burden, natural history and tendency for complication development in Aboriginal people with or at risk of type 2 diabetes. Led by Professor Alex Brown and funded by The Hospital Research Foundation, the project will outline the social, psychological, behavioural, clinical, metabolic and genomic predictors of disease and complication development utilising advanced, integrated epidemiological and genomic methods. Find out more: 🔗 https://bit.ly/4iuJEM7

Dear Colleagues, A recent publication in Medical Science Monitor explores the efficacy and safety of direct oral anticoagulants (DOACs) combined with mechanical thrombectomy in patients with venous thromboembolism (VTE), including those with inherited thrombophilia. The study, encompassing 55 patients, found no significant differences in outcomes such as recurrent VTE, bleeding events, or all-cause mortality between those with and without thrombophilia. These findings could inform treatment strategies for VTE patients undergoing mechanical thrombectomy, regardless of thrombophilia status. The complete report is now available on the Medical Science Monitor webpage. | https://lnkd.in/gcUMJwcs

The practice of evaluation creates opportunities to adapt, improve and respond. This publication in the Journal of Clinical and Translational Science details the impact of evaluators and their roles within the CTSA consortium. Takeaways include CTSA consortium knowledge in evaluation, best practices, evidenced-based recommendations for evaluation practice (at both national and group-level), and prompt use by other large evaluation consortia. Read more here: https://ow.ly/HYuC50Up8vh #CTSAProgram

Dear Colleagues, A recent publication in Medical Science Monitor explores the efficacy and safety of direct oral anticoagulants (DOACs) combined with mechanical thrombectomy in patients with venous thromboembolism (VTE), including those with inherited thrombophilia. The study, encompassing 55 patients, found no significant differences in outcomes such as recurrent VTE, bleeding events, or all-cause mortality between those with and without thrombophilia. These findings could inform treatment strategies for VTE patients undergoing mechanical thrombectomy, regardless of thrombophilia status. The complete report is now available on the Medical Science Monitor webpage. | https://lnkd.in/grZFEftu

Randomized controlled trials are considered the gold standard in regulatory decision making, as observational studies are known to have important methodological limitations. However, real-world evidence (#RWE) may be helpful in specific situations.   Recently, PhD student Stefan Verweij and his colleagues, observed that for multiple sclerosis, real-world studies yielded treatment effect #estimates similar to those obtained from randomized controlled trials (#RCT’s). They compared evidence obtained from tens of published RCTs with evidence obtained from observational studies in a comprehensive systematic review and network meta analysis (#NMA), using posterior predictive distributions. The authors argue that, in regulatory decision making, observational studies may supplement pivotal randomized controlled trials in relapsing–remitting multiple sclerosis. For instance, by facilitating the extrapolation of trial results to the broader patient population. ➡ Do you want to learn more about this study? Read the open access article here: https://lnkd.in/ek9ZWsft #RegulatoryScience #MS Wouter Ahmed, Guiling Zhou, Dimitris Mavridis, Stavros Nikolakopoulos, Katrien Oude Rengerink, Maarten J. Bijlsma, Peter Mol, Prof. dr. Eelko Hak.