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245 1 0 _aIntroduction to Surgical Trials
_h[electronic resource] /
_cedited by Stephen Lyman, Olufemi R. Ayeni, Jason L. Koh, Norimasa Nakamura, Jón Karlsson.
250 _a1st ed. 2024.
264 1 _aCham :
_bSpringer Nature Switzerland :
_bImprint: Springer,
_c2024.
300 _aX, 215 p. 21 illus., 13 illus. in color.
_bonline resource.
336 _atext
_btxt
_2rdacontent
337 _acomputer
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338 _aonline resource
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505 0 _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.
520 _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.
650 0 _aOrthopedics.
650 0 _aEpidemiology.
650 0 _aSurgery.
650 0 _aBioinformatics.
_962472
650 1 4 _aOrthopaedics.
650 2 4 _aEpidemiology.
650 2 4 _aSurgery.
650 2 4 _aBioinformatics.
_962472
700 1 _aLyman, Stephen.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aAyeni, Olufemi R.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aKoh, Jason L.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aNakamura, Norimasa.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
700 1 _aKarlsson, Jón.
_eeditor.
_4edt
_4http://id.loc.gov/vocabulary/relators/edt
710 2 _aSpringerLink (Online service)
773 0 _tSpringer Nature eBook
776 0 8 _iPrinted edition:
_z9783031775628
776 0 8 _iPrinted edition:
_z9783031775642
776 0 8 _iPrinted edition:
_z9783031923043
856 4 0 _uhttps://doi.org/10.1007/978-3-031-77563-5
907 _a.b17077102
_b2025-08-25
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