Introduction to Surgical Trials (Record no. 66785)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04550nam a22005895i 4500 |
| 001 - CONTROL NUMBER | |
| control field | 978-3-031-77563-5 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | DE-He213 |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20251030114947.0 |
| 007 - PHYSICAL DESCRIPTION FIXED FIELD--GENERAL INFORMATION | |
| fixed length control field | cr nn 008mamaa |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250226s2024 sz | s |||| 0|eng d |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9783031775635 |
| -- | 978-3-031-77563-5 |
| 024 7# - OTHER STANDARD IDENTIFIER | |
| Standard number or code | 10.1007/978-3-031-77563-5 |
| Source of number or code | doi |
| 050 #4 - LIBRARY OF CONGRESS CALL NUMBER | |
| Classification number | RD701-811 |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MNS |
| Source | bicssc |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MED065000 |
| Source | bisacsh |
| 072 #7 - SUBJECT CATEGORY CODE | |
| Subject category code | MNS |
| Source | thema |
| 245 10 - TITLE STATEMENT | |
| Title | Introduction to Surgical Trials |
| Medium | [electronic resource] / |
| Statement of responsibility, etc. | edited by Stephen Lyman, Olufemi R. Ayeni, Jason L. Koh, Norimasa Nakamura, Jón Karlsson. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 1st ed. 2024. |
| 264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE | |
| Place of production, publication, distribution, manufacture | Cham : |
| Name of producer, publisher, distributor, manufacturer | Springer Nature Switzerland : |
| -- | Imprint: Springer, |
| Date of production, publication, distribution, manufacture, or copyright notice | 2024. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | X, 215 p. 21 illus., 13 illus. in color. |
| Other physical details | online resource. |
| 336 ## - CONTENT TYPE | |
| Content type term | text |
| Content type code | txt |
| Source | rdacontent |
| 337 ## - MEDIA TYPE | |
| Media type term | computer |
| Media type code | c |
| Source | rdamedia |
| 338 ## - CARRIER TYPE | |
| Carrier type term | online resource |
| Carrier type code | cr |
| Source | rdacarrier |
| 347 ## - DIGITAL FILE CHARACTERISTICS | |
| File type | text file |
| Encoding format | |
| Source | rda |
| 505 0# - FORMATTED CONTENTS NOTE | |
| Formatted contents note | SECTION 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 ## - SUMMARY, ETC. | |
| Summary, etc. | Filling 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 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 70127 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 65983 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 72080 |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 64050 |
| 650 14 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 70129 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 65983 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 72080 |
| 650 24 - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name as entry element | |
| 9 (RLIN) | 64050 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Lyman, Stephen. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 90945 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Ayeni, Olufemi R. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 90946 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Koh, Jason L. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 90947 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Nakamura, Norimasa. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 90948 |
| 700 1# - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Karlsson, Jón. |
| Relator term | editor. |
| Relator code | edt |
| -- | http://id.loc.gov/vocabulary/relators/edt |
| 9 (RLIN) | 90949 |
| 710 2# - ADDED ENTRY--CORPORATE NAME | |
| Corporate name or jurisdiction name as entry element | SpringerLink (Online service) |
| 773 0# - HOST ITEM ENTRY | |
| Title | Springer Nature eBook |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9783031775628 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9783031775642 |
| 776 08 - ADDITIONAL PHYSICAL FORM ENTRY | |
| Relationship information | Printed edition: |
| International Standard Book Number | 9783031923043 |
| 856 40 - ELECTRONIC LOCATION AND ACCESS | |
| Uniform Resource Identifier | <a href="https://doi.org/10.1007/978-3-031-77563-5">https://doi.org/10.1007/978-3-031-77563-5</a> |
| 912 ## - | |
| -- | ZDB-2-SME |
| 912 ## - | |
| -- | ZDB-2-SXM |
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