Surgical Innovation and Evaluation 1 Evaluation and stages of surgical innovations

被引：421

作者：

Barkun, Jeffrey S. ^{[1
]}

Aronson, Jeffrey K. ^{[2
]}

Feldman, Liane S. ^{[1
]}

Maddern, Guy J. ^{[3
]}

Strasberg, Steven M. ^{[4
]}

机构：

[1] McGill Univ, Ctr Hlth, Montreal, PQ H3A 1A1, Canada

[2] Univ Dept Primary Hlth Care, Oxford, England

[3] Univ Adelaide, Discipline Surg, Queen Elizabeth Hosp, Adelaide, SA 5005, Australia

[4] Washington Univ, St Louis, MO USA

来源：

LANCET | 2009年 / 374卷 / 9695期

关键词：

RANDOMIZED CONTROLLED-TRIALS; ENDOSCOPIC SURGERY; CLINICAL-TRIALS; TECHNOLOGIES; CHALLENGES; GUIDANCE; QUALITY; CARE;

D O I：

10.1016/S0140-6736(09)61083-7

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

引用

页码：1089 / 1096

页数：8

共 61 条

[1] Drug safety - Anecdotes that provide definitive evidence
Aronson, Jeffrey K.
Hauben, Manfred
[J]. BMJ-BRITISH MEDICAL JOURNAL, 2006, 333 (7581): : 1267 - 1269
[2] Standards of reporting of randomized controlled trials in general surgery - Can we do better?
Balasubramanian, Sabapathy P.
Wiener, Martin
Alshameeri, Zeiad
Tiruvoipati, Ravindranath
Elbourne, Diana
Reed, Malcolm W.
[J]. ANNALS OF SURGERY, 2006, 244 (05) : 663 - 667
[3] Is surgical science dead?
Barker, CF
Kaiser, LR
[J]. JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS, 2004, 198 (01) : 1 - 19
[4] Quality of full and final publications reporting acute stroke trials - A systematic review
Bath, FJ
Owen, VE
Bath, PMW
[J]. STROKE, 1998, 29 (10) : 2203 - 2210
[5] DETECTING ADVERSE REACTIONS TO DRUGS
BENNETT, PN
[J]. HUMAN TOXICOLOGY, 1988, 7 (05): : 465 - 467
[6] Limitations of randomized clinical trials for evaluating emerging operations: The case of lung volume reduction surgery
Berger, RL
Celli, BR
Meneghetti, AL
Bagley, PH
Wright, CD
Ingenito, EP
Gray, A
Snider, GL
[J]. ANNALS OF THORACIC SURGERY, 2001, 72 (02) : 649 - 657
[7] Evaluating surgical outcomes
Bergman, S
Feldman, LS
Barkun, JS
[J]. SURGICAL CLINICS OF NORTH AMERICA, 2006, 86 (01) : 129 - +
[8] Surgical innovation or surgical evolution: an ethical and practical guide to handling novel neurosurgical procedures
Bernstein, M
Bampoe, J
[J]. JOURNAL OF NEUROSURGERY, 2004, 100 (01) : 2 - 7
[9] Responsible development and application of surgical innovations: A position statement of the Society of University Surgeons
Biffl, Walter L.
Spain, David A.
Reitsma, Angelique M.
Minter, Rebecca M.
Upperman, Jeffrey
Wilson, Mark
Adams, Reid
Goldman, Edward B.
Angelos, Peter
Krummel, Thomas
Greenfield, Lazar J.
[J]. JOURNAL OF THE AMERICAN COLLEGE OF SURGEONS, 2008, 206 (06) : 1204 - 1209
[10] The history and contemporary challenges of the US Food and Drug Administration
Borchers, Andrea T.
Hagie, Frank
Keen, Carl L.
Gershwin, M. Eric
[J]. CLINICAL THERAPEUTICS, 2007, 29 (01) : 1 - 16

← 1 2 3 4 5 6 7 →