2025 -  WEEK 3 - What's New in RWE Research

 

  1. DAA-PASS: A Prospective Evaluation of HCC Recurrence After Direct Acting Antiviral Therapy. Singal AG, Reddy KR, Colombo M, Morris HL, Mospan AR, Cabrera R, Kelley RK, Kilpatrick RD, Trevisani F, Farinati F, Giannini EG, Mehta N, Fried MW, Sangro B; DAA‐PASS and ITA.LI.CA Investigators. J Viral Hepat. 2025 Feb;32(2):e14056. https://pubmed.ncbi.nlm.nih.gov/39822115/
  2. Real-world study on disease burden and current clinical practice of hospital-acquired pneumonia in Japan. Kimata M, Aoki Y, Akiyama T, Harada A. J Infect Chemother. 2025 Feb;31(2):102551. https://pubmed.ncbi.nlm.nih.gov/39510446/
  3. INSIGHT: A Tool for Fit-for-Purpose Evaluation and Quality Assessment of Standardized Observational Data Sources for Real World Evidence on Medicine and Vaccine Safety. Hoxhaj V, Andaur Navarro CL, Riera-Arnau J, Elbers RJHJ, Alsina E, Dodd C, Sturkenboom MCJM. Pharmacoepidemiol Drug Saf. 2025 Jan;34(1):e70089. https://pubmed.ncbi.nlm.nih.gov/39805807/
  4. Switching to faricimab from the current anti-VEGF therapy: evidence-based expert recommendations. Wong DT, Aboobaker S, Maberley D, Sharma S, Yoganathan P.BMJ Open Ophthalmol. 2025 Jan 16;10(1):e001967. https://pubmed.ncbi.nlm.nih.gov/39824523/
  5. Cardiovascular safety of osteoanabolic agents. Takeuchi Y.J Bone Miner Metab. 2025 Jan 17. https://pubmed.ncbi.nlm.nih.gov/39825110/
  6. Modeling of Disease Progression of Type 2 Diabetes Using Real-World Data: Quantifying Competing Risks of Morbidity and Mortality. Kunina H, Franzén S, Kjellsson MC.CPT Pharmacometrics Syst Pharmacol. 2025 Jan 17. https://pubmed.ncbi.nlm.nih.gov/39825570/
  7. Idecabtagene vicleucel or ciltacabtagene autoleucel for relapsed or refractory multiple myeloma: An international multicenter study. Merz M, Albici AM, von Tresckow B, Rathje K, Fenk R, Holderried T, Müller F, Tovar N, Oliver-Cáldes A, Vucinic V, Kharboutli S, Bärmann BN, Ayuk F, Platzbecker U, Stölzel F, Schub N, Schmitz F, Fandrei D, Born P, Khandanpour C, Hanoun C, Hörster K, Teichert M, Jeker B, Hoffmann M, Kröger N, de Larrea CF, Pabst T, Gagelmann N. Hemasphere. 2025 Jan 16;9(1):e70070. https://pubmed.ncbi.nlm.nih.gov/39822585/
  8. Treatment of Venous Thromboembolism with Edoxaban over 18 Months: Results from ETNA-VTE Europe. Agnelli G, Hoffmann U, Hainaut P, Gaine S, Ay C, Coppens M, Schindewolf M, Jimenez D, Fronk EM, Souza J, Laeis P, Bramlage P, Brüggenjürgen B, Levy P, Cohen AT; ETNA-VTE-Europe investigators.Thromb Haemost. 2025 Jan 16. https://pubmed.ncbi.nlm.nih.gov/39821724/
  9. CAR T access and outcomes in large B-cell lymphoma according to ethnicity and socioeconomic deprivation in the UK. Dragoi D, Cusworth S, Oldham L, Sanderson R, Norman J, Chandan J, Mathew A, Kumar E, Paneesha S, Tholouli E, Moya Davila A, Bouziana S, Patten P, Hardefeldt P, Yallop D, Chaganti S, Burns D, Kuhnl A.Br J Haematol. 2025 Jan 16. https://pubmed.ncbi.nlm.nih.gov/39821591/
  10. Characteristics of patients with polymyalgia rheumatica based on glucocorticoid dose in Japan: A cohort study using routinely collected health data. Tanaka Y, Takahashi T, Inokuchi S, Uenaka H, Fujita A, Sakamoto K.Mod Rheumatol. 2025 Jan 17:roaf001. https://pubmed.ncbi.nlm.nih.gov/39821299/
  11. Effectiveness and Safety of Vildagliptin Sustained Release in the Management of Type 2 Diabetes Mellitus: Real-World Evidence in Indian Patients [NOVELTY Study]. Sahay R, Bhansali A, Sharma SK, Iyer R, Sugumaran A, Mohanasundaram S, Gogtay J.Drugs Real World Outcomes. 2025 Jan 16. https://pubmed.ncbi.nlm.nih.gov/39821190/
  12. Optimizing real-world evidence studies for regulatory decision-making and impact assessment in pharmacovigilance. Ioakeim-Skoufa I, Atkins K, Hernández-Rodríguez MÁ.Br J Clin Pharmacol. 2025 Jan 17. https://pubmed.ncbi.nlm.nih.gov/39821103/
  13. Genetic Testing in Potential Kidney Transplant Recipients and Their Donors: Building on What We Know Through New Real World Evidence. Jahan S, Mallett AJ.Transplantation. 2025 Jan 14. https://pubmed.ncbi.nlm.nih.gov/39820423/
  14. Two-year outcomes using fast-acting sub-perception therapy for spinal cord stimulation: results of a real-world multicenter study in the United States. Metzger C, Hammond B, Ferro R, North J, Pyles S, Kranenburg A, Washabaugh E, Goldberg E.Expert Rev Med Devices. 2025 Jan 16. https://pubmed.ncbi.nlm.nih.gov/39819320/
  15. Decision model to evaluate the cost of clinical events associated with switching from Apixaban to Rivaroxaban among patients with non-valvular atrial fibrillation in the United States and Germany. Subash R, Duan C, Shah A, Hines DM, Zhang M, Kongnakorn T, Dworatzek E, Kisser A, Hagan M.J Med Econ. 2025 Jan 17:1-16. https://pubmed.ncbi.nlm.nih.gov/39819252/
  16. Association between prophylactic antibiotics for endometrial biopsy and the incidence of pelvic inflammatory disease: A retrospective cohort study. Ishida R, Sasabuchi Y, Koga K, Izumi G, Shigemi D, Matsui H, Yasunaga H, Osuga Y.Int J Gynaecol Obstet. 2025 Jan 16. https://pubmed.ncbi.nlm.nih.gov/39817441/
  17. Cardiovascular safety of 5-fluorouracil and capecitabine in colorectal cancer patients: real-world evidence. Wong CK, Ho I, Choo A, Lau R, Ma TF, Chiu ACH, Lam TH, Lin M, Leung RW, Chor-Cheung Tam F, Chung Foo DC, Tse HF.Cardiooncology. 2025 Jan 15;11(1):3. https://pubmed.ncbi.nlm.nih.gov/39815329/
  18. Incidence of seroma and postoperative complications after breast surgery before and during the Covid-19 pandemic: results from a retrospective multicenter analysis. Beck MH, Brachaczek IA, Gebert P, Blohmer JU, Kaya AC, Zimmermann JSM, Radosa JC, Karsten MM.BMC Cancer. 2025 Jan 15;25(1):91. https://pubmed.ncbi.nlm.nih.gov/39815186/
  19. Real-World Evidence on Digital Therapeutics in Pediatric Amblyopia: Insights into Rapid Axial Elongation Risk. Yao Y, He Y, Wen Y, Feng L, Ye Q, Xu Z, Zhou Y, Pang Y, Yu W, Zhong Y, Li Q, Yuan J, Liu J, Li J. Ophthalmology. 2025 Jan 13:S0161-6420(25)00031-4. https://pubmed.ncbi.nlm.nih.gov/39814322/
  20. Prospective clinical evidence from over 1,000 pan-cancer patients: a complement to fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting. He L, Wang J, Pu W, Li H, Liu B, Wang Z, Han Q, Wang Y, Xu B, Hu J, Sun G, Chen H.BMC Cancer. 2025 Jan 14;25(1):82. https://pubmed.ncbi.nlm.nih.gov/39810173/
  21. Cost-utility analysis of combination medical therapies in chronic coronary syndrome: a comparative study using real-world and patient-level data from Iran. Davari M, Fatemi B, Sadeghipour P, Kebriaeezadeh A, Maracy MR, Soleymani F, Naderi N, Zartab S.BMJ Open. 2025 Jan 14;15(1):e081953. https://pubmed.ncbi.nlm.nih.gov/39809567/
  22. Characterization of Individuals Achieving Type 2 Diabetes Remission in Real-World Settings: Bridging Clinical Evidence and Patient Experiences. Marcotte-Chénard A, Oliveira B, Rahman T, McKelvey S, Elliott T, Rocha P, MacKay DS, Little JP. Appl Physiol Nutr Metab. 2025 Jan 14. https://pubmed.ncbi.nlm.nih.gov/39808777/
  23. Advancing Principled Pharmacoepidemiologic Research to Support Regulatory and Healthcare Decision Making: The Era of Real-World Evidence. Hernandez RK, Critchlow CW, Dreyer N, Lash TL, Reynolds RF, Sørensen HT, Lange JL, Gatto NM, Sobel RE, Lai EC, Schoonen M, Brown JS, Christian JB, Brookhart MA, Bradbury BD. Clin Pharmacol Ther. 2025 Jan 14. https://pubmed.ncbi.nlm.nih.gov/39807817/
  24. The impact of allergic rhinitis on future educational outcomes: a Danish real-world register study. Voss Vahlkvist S, Romano Rodriguez M, Pedersen M, Houmann Petersen T. Curr Med Res Opin. 2025 Jan 14:1-11. https://pubmed.ncbi.nlm.nih.gov/39807541/
  25. Association of a remote monitoring programme with all-cause mortality and hospitalizations in patients with heart failure: National-scale, real-world evidence from a 3-year propensity score analysis of the TELESAT-HF study. Girerd N, Barbet V, Seronde MF, Benchimol H, Jagu A, Tartière JM, Hanon O, Picard F, Lafitte S, Lemaitre M, Pages N, Nisse-Durgeat S, Jourdain P. Eur J Heart Fail. 2025 Jan 14. https://pubmed.ncbi.nlm.nih.gov/39807086/
  26. Risk of insulin initiation with sodium-glucose cotransporter-2 inhibitors versus dipeptidyl peptidase-4 inhibitors in patients with type 2 diabetes mellitus: A real-world claims database study in Japan. Suzuki R, Shoji S, Yoshinaga Y, Kosakai Y, Shintani-Tachi M.Diabetes Obes Metab. 2025 Jan 13. https://pubmed.ncbi.nlm.nih.gov/39806567/
  27. Association Between Child Varicella Vaccination and Zoster in Household Adults: A Retrospective Japanese Cohort Study. Sato S, Ono S, Sasabuchi Y, Michihata N, Uemura K, Yasunaga H. Acta Paediatr. 2025 Jan 13. https://pubmed.ncbi.nlm.nih.gov/39804145/
  28. A retrospective observational analysis of the real-world care pathway of people with hereditary transthyretin amyloidosis with polyneuropathy in Italy. Calabria S, Ronconi G, Dondi L, Dondi L, Dell'Anno I, Piccinni C, Esposito I, Addesi A, Gnesi M, Cosentino N, D'Amelio M, Martini N, Maggioni AP.Expert Rev Pharmacoecon Outcomes Res. 2025 Jan 14:1-8. https://pubmed.ncbi.nlm.nih.gov/39773081/
  29. Effectiveness and Safety of the TRIO Optimal Health Management Program in Patients With Type 2 Diabetes Mellitus Initiating Basal Insulin Therapy: Prospective Observational Real-World Study. Li C, Guo L, Shi L, Chen L, Chen L, Xue Y, Li H, Liang Y, Yang J, Wang W, Zhu D.J Med Internet Res. 2025 Jan 13;27:e67554. https://pubmed.ncbi.nlm.nih.gov/39694849/
  30. China TCM Cardio Bank (CTC Bank): a high-quality, large-sample and real-world research database. Li Y, Liu Y, Zhu M, Wang W, Chen K, Huang L, Xu F, Liu Y.Sci Bull (Beijing). 2025 Jan 15;70(1):1-3. https://pubmed.ncbi.nlm.nih.gov/39567284/
  31. Trends in Blood Pressure Control among US Adults With Hypertension, 2013-2014 to 2021-2023. Hardy ST, Jaeger BC, Foti K, Ghazi L, Wozniak G, Muntner P.Am J Hypertens. 2025 Jan 16;38(2):120-128. https://pubmed.ncbi.nlm.nih.gov/39504487/

 

REVIEWS

  1. A systematic literature review of real-world evidence (RWE) on post-market assessment of medical devices. Manetti S, Guidotti E, Vola F, Vainieri M.Health Econ Policy Law. 2025 Jan 13:1-33. https://pubmed.ncbi.nlm.nih.gov/39801351/
  1. Methodological standards for comparative effectiveness research: considerations for evidentiary review for medicare drug price negotiation. Doshi R, Divino V, Greenwalt L, DeKoven M. Expert Rev Pharmacoecon Outcomes Res. 2025 Jan 17:1-7. https://pubmed.ncbi.nlm.nih.gov/39799556/
  1. Unraveling Cardiovascular Risks and Benefits of COVID-19 Vaccines: A Systematic Review. Satyam SM, El-Tanani M, Bairy LK, Rehman A, Srivastava A, Kenneth JM, Prem SM.Cardiovasc Toxicol. 2025 Jan 18. https://pubmed.ncbi.nlm.nih.gov/39826014/
  1. Real-World Effectiveness and Tolerability of Dolutegravir and Lamivudine 2-Drug Regimen in People Living with HIV: Systematic Literature Review and Meta-Analysis. Fraysse J, Priest J, Turner M, Hill S, Jones B, Verdier G, Letang E.Infect Dis Ther. 2025 Jan 18. doi: 10.1007/s40121-024-01103-0. Online ahead of print.PMID: 39826080 Review. https://pubmed.ncbi.nlm.nih.gov/39826080/
  1. Real-world effectiveness of mepolizumab in asthma: a systematic review and meta-analysis. Di Bona D, Paoletti G, Carlucci P, Spataro F, Weng S, Howarth P, Canonica GW.J Asthma. 2025 Jan 17:1-11. https://pubmed.ncbi.nlm.nih.gov/39812421/
  1. Methodological challenges using routine clinical care data for real-world evidence: a rapid review utilizing a systematic literature search and focus group discussion. Pfaffenlehner M, Behrens M, Zöller D, Ungethüm K, Günther K, Rücker V, Reese JP, Heuschmann P, Kesselmeier M, Remo F, Scherag A, Binder H, Binder N; EVA4MII project. BMC Med Res Methodol. 2025 Jan 14;25(1):8. https://pubmed.ncbi.nlm.nih.gov/39810151/
  2. Collaborative Real-World Evidence Among Regulators: Lessons and Perspectives. Beck AE, Kampman M, Huynh C, Simon C, Plueschke K, Cohet C, Verpillat P, Robinson K, Arlett P. Clin Pharmacol Ther. 2025 Feb;117(2):368-373. https://pubmed.ncbi.nlm.nih.gov/39434493/