東華大學圖書館 |

Language: English

Help

回圖書館首頁

手機版館藏查詢

Back

Switch To: Labeled | MARC Mode | ISBD

Introduction to surgical trials

Lyman, Stephen.

Linked to FindBook

Google Book

Amazon

博客來

Introduction to surgical trials

Record Type:	Electronic resources : Monograph/item
Title/Author:	Introduction to surgical trials/ edited by Stephen Lyman ... [et al.].
other author:	Lyman, Stephen.
Published:	Cham :Springer Nature Switzerland : : 2024.,
Description:	x, 215 p. :ill., digital ;24 cm.
[NT 15003449]:	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.
Contained By:	Springer Nature eBook
Subject:	Bioinformatics. -
Online resource:	https://doi.org/10.1007/978-3-031-77563-5
ISBN:	9783031775635

Introduction to surgical trials
Introduction to surgical trials[electronic resource] /edited by Stephen Lyman ... [et al.]. - Cham :Springer Nature Switzerland :2024. - x, 215 p. :ill., digital ;24 cm.

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.

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.

ISBN: 9783031775635

Standard No.: 10.1007/978-3-031-77563-5doiSubjects--Topical Terms:

553671
Bioinformatics.

LC Class. No.: RD29

Dewey Class. No.: 617.027

Introduction to surgical trials
LDR:03229nmm a2200325 a 4500 001 2389601
003 DE-He213
005 20250226115235.0
006 m d
007 cr nn 008maaau
008 250916s2024 sz s 0 eng d
020 $a 9783031775635 $q (electronic bk.)
020 $a 9783031775628 $q (paper)
024 7 $a 10.1007/978-3-031-77563-5 $2 doi
035 $a 978-3-031-77563-5
040 $a GP $c GP
041 0 $a eng
050 4 $a RD29
072 7 $a MNS $2 bicssc
072 7 $a MED065000 $2 bisacsh
072 7 $a MNS $2 thema
082 0 4 $a 617.027 $2 23
090 $a RD29 $b .I61 2024
245 0 0 $a Introduction to surgical trials $h [electronic resource] / $c edited by Stephen Lyman ... [et al.].
260 $a Cham : $b Springer Nature Switzerland : $b Imprint: Springer, $c 2024.
300 $a x, 215 p. : $b ill., digital ; $c 24 cm.
505 0 $a 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 $a 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 2 4 $a Bioinformatics. $3 553671
650 0 $a Surgery $x Research. $3 1086663
650 0 $a Surgery $x Research $x Moral and ethical aspects. $3 3755371
650 1 4 $a Orthopaedics. $3 3538904
650 2 4 $a Epidemiology. $3 568544
650 2 4 $a Surgery. $3 707153
700 1 $a Lyman, Stephen. $3 3755370
710 2 $a SpringerLink (Online service) $3 836513
773 0 $t Springer Nature eBook
856 4 0 $u https://doi.org/10.1007/978-3-031-77563-5
950 $a Medicine (SpringerNature-11650)