Lung Cancer 52(2): 155–163.īuikhuisen WA, Burgers JA, Vincent AD, Korse CM, van Klaveren RJ, Schramel FM, Pavlakis N, Nowak AK, Custers FL, Schouwink JH, Gans SJ, Groen HJ, Strankinga WF, Baas P (2013) Thalidomide versus active supportive care for maintenance in patients with malignant mesothelioma after first-line chemotherapy (NVALT 5): an open-label, multicentre, randomised phase 3 study. J Clin Oncol 27: 4454–4461.īrodowicz T, Krzakowski M, Zwitter M, Tzekova V, Ramlau R, Ghilezan N, Ciuleanu T, Cucevic B, Gyurkovits K, Ulsperger E, Jassem J, Grgic M, Saip P, Szilasi M, Wiltschke C, Wagnerova M, Oskina N, Soldatenkova V, Zielinski C, Wenczl M Central European Cooperative oncology group CECOG (2006) Cisplatin and gemcitabine first-line chemotherapy followed by maintenance gemcitabine or best supportive care in advanced non-small cell lung cancer: a phase III trial. JAMA 302: 741–749.īellmunt J, Theodore C, Demkov T, Komyakov B, Sengelov L, Daugaard G, Caty A, Carles J, Jagiello-Gruszfeld A, Karyakin O, Delgado FM, Hurteloup P, Winquist E, Morsli N, Salhi Y, Culine S, Von der Maase H (2009) Phase III trial of vinflunine plus best supportive care compared with best supportive care alone after a platinum-containing regimen in patients with advanced transitional cell carcinoma of the urothelial tract. Cochrane Database Syst Rev CD003445.īakitas M, Lyons KD, Hegel MT, Balan S, Brokaw FC, Seville J, Hull JG, Li Z, Tosteson TD, Byock IR, Ahles TA (2009) Effects of a palliative care intervention on clinical outcomes in patients with advanced cancer: the Project ENABLE II randomized controlled trial. Such studies risk systematically over-estimating the net clinical effect of the comparator arms.Īhmed N, Ahmedzai S, Vora V, Hillam S, Paz S (2004) Supportive care for patients with gastrointestinal cancer. Reporting of BSC in trials is incomplete, resulting in uncertain internal and external validity. No studies reported offering access to palliative care specialists. No studies reported educating patients about symptom management or goals of therapy. None documented evidence-based symptom management. One-third reported symptom assessment at identical intervals in both arms. One-third of articles offered a detailed description of BSC, 61% reported regular symptom assessment, and 44% reported using validated symptom assessment measures. Overall, trials conformed to the CONSORT guidelines better than the BSC standards (28% vs 16%). Of 408 articles retrieved, we retained 18 after applying exclusion criteria. For maximum quality and value, InControl Diapers manufactures their own line of premium reusable diaper covers in Rubber, PVC and PUL. With over three decades of experience, their washable options are known as the best in the world for quality and durability. We reviewed trials including BSC control arms from 2002 to 2014 to assess concordance to BSC standards and to selected items from the CONSORT 2010 guidelines. InControl Diapers is the leading supplier of premium cloth diapers and pads. We conducted a review to evaluate clinical trials' concordance with published, consensus-based framework for BSC delivery in trials.Ī consensus-based Delphi panel previously identified four key domains of BSC delivery in trials: multidisciplinary care supportive care documentation symptom assessment and symptom management. Best supportive care (BSC) as a control arm in clinical trials is poorly defined.
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