LEADER 05254nam 22009375 450 001 9910983345103321 005 20260302154940.0 010 $a9783031775635 010 $a3031775635 024 7 $a10.1007/978-3-031-77563-5 035 $a(MiAaPQ)EBC31922850 035 $a(Au-PeEL)EBL31922850 035 $a(CKB)37723033200041 035 $a(DE-He213)978-3-031-77563-5 035 $a(OCoLC)1507699551 035 $a(EXLCZ)9937723033200041 100 $a20250226d2024 uy 0 101 0 $aeng 135 $aurcnu|||||||| 181 $ctxt$2rdacontent 182 $cc$2rdamedia 183 $acr$2rdacarrier 200 00$aIntroduction to surgical trials /$fedited by Stephen Lyman, Olufemi R. Ayeni, Jason L. Koh, Norimasa Nakamura, Jón Karlsson 205 $aFirst edition. 210 1$aCham :$cSpringer Nature Switzerland :$cImprint: Springer,$d[2024] 215 $a1 online resource (x, 215 pages) $cillustrations 225 0 $aMedicine Series 311 08$a9783031923043 311 08$a3031923049 311 08$a9783031775628 311 08$a3031775627 320 $aIncludes bibliographical references. 327 $aSECTION A: Trial Design -- Why Do We Need Surgical Trials? -- Addressing the Challenges to Surgical Randomization -- Randomization Strategies -- Surgical Trial Design: Interventions & Blinding -- Sample Size and Power Considerations for Surgical Trials -- Optimizing Recruitment in Randomized Controlled Trials -- Treatment Allocation -- Crossover and early failure in surgical trials -- Strategies to Optimize Follow-up in Surgical Trials -- Considerations in Choosing Outcomes Measures -- Length of Follow-Up -- SECTION B: Conducting a Trial -- Ethics considerations and approval in human research and in orthopaedics -- Trial Start Up Considerations: Budget, Staffing, Logistics -- Adverse Events Reporting & Data and Safety MonitoringTrial Closeout -- SECTION C: Trial Completion -- Missing Data & Imputation -- Statistical Analysis for Surgical Trials -- CONSORT Reporting Standards -- SECTION D: Regulatory Standards -- The Regulatory Pathway to Market Class III Surgical Medical Devices in the United States -- European Standards -- Regulatory Standards for Surgical Trials in Asia: the Japanese Experience -- SECTION E: Alternatives to the Classic RCT -- Pragmatic TrialsPlatform Trials -- Prospecitve Cohort StudiesSurgical Registries -- The Future of Trials. 330 $aFilling a gap in literature, this book examines surgical trials with a special focus on the underlying principles, challenges, and best practices to successfully conduct rigorous surgical research. While randomized controlled trials (RCTs) remain the gold standard for evaluation of the safety and efficacy of most medical interventions, they are particularly difficult to implement successfully in the context of surgery. As a result, recruitment rates are often extremely low, crossover from non-operative to operative is common, and patients randomly allocated to surgery often simply decline to have the procedure. All of these challenges call into question the recent generalizability and fundamental quality of traditional surgical RCTs. As such, this book explores advanced alternative trial design methods and describes the current regulatory environment around the world. Designed as a practical guide, it is a valuable tool for surgeons, epidemiologist and biostatisticians involved in this challenging field. 517 3 $aSurgical trials 606 $aSurgery$xResearch 606 $aSurgery$xResearch$xMoral and ethical aspects 606 $aOrthopedics 606 $aEpidemiology 606 $aSurgery 606 $aBiometry 606 $aBioinformatics 606 $aGeneral Surgery$xmethods$3(DNLM)D013502Q000379 606 $aClinical Trials as Topic$3(DNLM)D002986 606 $aResearch Design$3(DNLM)D012107 606 $aBiostatistics$3(DNLM)D056808 606 $aComputational Biology$3(DNLM)D019295 606 $aEpidemiologic Research Design$3(DNLM)D015340 606 $aOrthopedic Procedures$xmethods$3(DNLM)D019637Q000379 606 $aEpidemiology$3(DNLM)D004813 606 $aOrthopedics$3(DNLM)D009985 615 0$aSurgery$xResearch. 615 0$aSurgery$xResearch$xMoral and ethical aspects. 615 0$aOrthopedics. 615 0$aEpidemiology. 615 0$aSurgery. 615 0$aBiometry. 615 0$aBioinformatics. 615 12$aGeneral Surgery$xmethods 615 12$aClinical Trials as Topic 615 22$aResearch Design 615 22$aBiostatistics 615 22$aComputational Biology 615 22$aEpidemiologic Research Design 615 22$aOrthopedic Procedures$xmethods 615 2$aEpidemiology. 615 2$aOrthopedics 676 $a616.7 702 $aLyman$b Stephen$f1970- 702 $aAyeni$b Olufemi R. 702 $aKoh$b Jason 702 $aNakamura$b Norimasa 702 $aKarlsson$b Jon 712 02$aInternational Society of Arthroscopy, Knee Surgery, and Orthopaedic Sports Medicine, 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910983345103321 996 $aIntroduction to surgical trials$94547355 997 $aUNINA