دورية أكاديمية
Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): A multicenter stepped-wedge cluster randomized controlled trial
| العنوان: | Impact of nationwide enhanced implementation of best practices in pancreatic cancer care (PACAP-1): A multicenter stepped-wedge cluster randomized controlled trial |
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| المؤلفون: | Mackay, T.M. (Tara M.), Smits, F.J. (F. J.), Latenstein, A.E.J. (A. E.J.), Bogte, A. (A.), Bonsing, B.A. (Bert), Bos, H. (H.), Bosscha, K. (Koop), Brosens, L.A. (Lodewijk), Hol, L. (L.), Busch, O.R.C. (Olivier), Creemers, G.J.M. (Geert-Jan), Curvers, W.L. (W. L.), Dulk, M. (Marcel) den, Van Dieren, S. (Susan), Van Driel, L.M.J.W. (L. M.J.W.), Festen, S. (Sebastiaan), Geenen, E-J.M. (Erwin-Jan), van der Geest, L.G.M. (Lydia G.M.), De Groot, D.J.A. (D. J.A.), Groot, J.W.B. (Jan Willem) de, Haj Mohammad, N. (Nadia), Haberkorn, B. (Brigitte), Haver, J.T. (J. T.), Harst, E. (Erwin) van der, Hemmink, G.J.M. (G. J.M.), Hingh, I.H.J.T. (Ignace) de, Hoge, C. (C.), Homs, M.Y.V. (Marjolein), Van Huijgevoort, N.C. (N. C.), Jacobs, M.A.J.M. (Maarten), Kerver, E.D. (E. D.), Liem, M. (Marieke), Los, M., Lubbinge, H. (H.), Luelmo, S.A.C. (S. A.C.), Meijer, V.E. (Vincent) de, Mekenkamp, L. (L.), Molenaar, I.Q. (I. Quintus), Oijen, M.G.H. (Martijn) van, Patijn, G.A. (Gijs A.), Quispel, R. (Rutger), van Rijssen, L.B. (Lennart B.), Römkens, T.E.H., Santvoort, H.C. (Hjalmar) van, Schreinemakers, J.M.J. (Jennifer), Schut, H. (H.), Seerden, T.C.J. (Tom), Stommel, M.W.J. (M. W.J.), Tije, A.J. (Albert Jan) ten, Venneman, N.G. (Niels), Verdonk, R.C. (Robert), Verheij, J. (Joanne), Vilsteren, F.G.I. (Frederike) van, de Vos-Geelen, J. (Judith), Vulink, A. (A.), Wientjes, C. (C.), Wit, F. (F.), Wessels, F.J. (F. J.), Zonderhuis, B. (B.), Van Werkhoven, C.H. (C. H.), Hooft, J.E. (Jeanin) van, Eijck, C.H.J. (Casper) van, Wilmink, J.W. (J. W.), Laarhoven, H.W.M. (Hanneke) van, Besselink, M.G. (Marc) |
| المصدر: | Trials vol. 21 no. 1 |
| سنة النشر: | 2020 |
| المجموعة: | RePub - Publications from Erasmus University, Rotterdam |
| مصطلحات موضوعية: | Best practices, Biliary drainage, Chemotherapy, Implementation, Pancreatic cancer, Pancreatic enzyme replacement therapy, Quality of life, Registry, Stepped-wedge cluster randomized controlled trial, Survival |
| الوصف: | Background: Pancreatic cancer has a very poor prognosis. Best practices for the use of chemotherapy, enzyme replacement therapy, and biliary drainage have been identified but their implementation in daily clinical practice is often suboptimal. We hypothesized that a nationwide program to enhance implementation of these best practices in pancreatic cancer care would improve survival and quality of life. Methods/design: PACAP-1 is a nationwide multicenter stepped-wedge cluster randomized controlled superiority trial. In a per-center stepwise and randomized manner, best practices in pancreatic cancer care regarding the use of (neo)adjuvant and palliative chemotherapy, pancreatic enzyme replacement therapy, and metal biliary stents are implemented in all 17 Dutch pancreatic centers and their regional referral networks during a 6-week initiation period. Per pancreatic center, one multidisciplinary team functions as reference for the other centers in the network. Key best practices were identified from the literature, 3 years of data from existing nationwide registries within the Dutch Pancreatic Cancer Project (PACAP), and national expert meetings. The best practices follow the Dutch guideline on pancreatic cancer and the current state of the literature, and can be executed within daily clinical practice. The implementation process includes monitoring, return visits, and provider feedback in combination with education and reminders. Patient outcomes and compliance are monitored within the PACAP registries. Primary outcome is 1-year overall survival (for all disease stages). Secondary outcomes include quality of life, 3- and 5-year overall survival, and guideline compliance. An improvement of 10% in 1-year overall survival is considered clinically relevant. A 25-month study duration was chosen, which provides 80% statistical power for a mortality reduction of 10.0% in the 17 pancreatic cancer centers, with a required sample size of 2142 patients, corresponding to a 6.6% mortality reduction and 4769 patients ... |
| نوع الوثيقة: | article in journal/newspaper |
| وصف الملف: | application/pdf |
| اللغة: | English |
| العلاقة: | http://repub.eur.nl/pub/126326Test; urn:hdl:1765/126326 |
| DOI: | 10.1186/s13063-020-4180-z |
| الإتاحة: | https://doi.org/10.1186/s13063-020-4180-zTest http://repub.eur.nl/pub/126326Test |
| حقوق: | info:eu-repo/semantics/openAccess |
| رقم الانضمام: | edsbas.DED3DE57 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1186/s13063-020-4180-z |
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