Literature DB >> 19782875

Challenges in evaluating surgical innovation.

Patrick L Ergina1, Jonathan A Cook, Jane M Blazeby, Isabelle Boutron, Pierre-Alain Clavien, Barnaby C Reeves, Christoph M Seiler, Douglas G Altman, Jeffrey K Aronson, Jeffrey S Barkun, W Bruce Campbell, Jonathan A Cook, Liane S Feldman, David R Flum, Paul Glasziou, Guy J Maddern, John C Marshall, Peter McCulloch, Jon Nicholl, Steven M Strasberg, Jonathan L Meakins, Deborah Ashby, Nick Black, John Bunker, Martin Burton, Marion Campbell, Kalipso Chalkidou, Iain Chalmers, Marc de Leval, Jon Deeks, Adrian Grant, Muir Gray, Roger Greenhalgh, Milos Jenicek, Sean Kehoe, Richard Lilford, Peter Littlejohns, Yoon Loke, Rajan Madhock, Kim McPherson, Peter Rothwell, Bill Summerskill, David Taggart, Parris Tekkis, Matthew Thompson, Tom Treasure, Ulrich Trohler, Jan Vandenbroucke.   

Abstract

Research on surgical interventions is associated with several methodological and practical challenges of which few, if any, apply only to surgery. However, surgical evaluation is especially demanding because many of these challenges coincide. In this report, the second of three on surgical innovation and evaluation, we discuss obstacles related to the study design of randomised controlled trials and non-randomised studies assessing surgical interventions. We also describe the issues related to the nature of surgical procedures-for example, their complexity, surgeon-related factors, and the range of outcomes. Although difficult, surgical evaluation is achievable and necessary. Solutions tailored to surgical research and a framework for generating evidence on which to base surgical practice are essential.

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Year:  2009        PMID: 19782875      PMCID: PMC2855679          DOI: 10.1016/S0140-6736(09)61086-2

Source DB:  PubMed          Journal:  Lancet        ISSN: 0140-6736            Impact factor:   79.321


  67 in total

1.  A fair way of donating hearts for transplantation.

Authors:  S Hunt
Journal:  BMJ       Date:  2000-09-02

2.  Complex interventions: how "out of control" can a randomised controlled trial be?

Authors:  Penelope Hawe; Alan Shiell; Therese Riley
Journal:  BMJ       Date:  2004-06-26

3.  Surgical vs nonoperative treatment for lumbar disk herniation: the Spine Patient Outcomes Research Trial (SPORT): a randomized trial.

Authors:  James N Weinstein; Tor D Tosteson; Jon D Lurie; Anna N A Tosteson; Brett Hanscom; Jonathan S Skinner; William A Abdu; Alan S Hilibrand; Scott D Boden; Richard A Deyo
Journal:  JAMA       Date:  2006-11-22       Impact factor: 56.272

Review 4.  Reporting of outcomes in orthopaedic randomized trials: does blinding of outcome assessors matter?

Authors:  Rudolf W Poolman; Peter A A Struijs; Rover Krips; Inger N Sierevelt; René K Marti; Forough Farrokhyar; Mohit Bhandari
Journal:  J Bone Joint Surg Am       Date:  2007-03       Impact factor: 5.284

5.  When are randomised trials unnecessary? Picking signal from noise.

Authors:  Paul Glasziou; Iain Chalmers; Michael Rawlins; Peter McCulloch
Journal:  BMJ       Date:  2007-02-17

6.  The Ipswich Childbirth Study: 1. A randomised evaluation of two stage postpartum perineal repair leaving the skin unsutured.

Authors:  B Gordon; C Mackrodt; E Fern; A Truesdale; S Ayers; A Grant
Journal:  Br J Obstet Gynaecol       Date:  1998-04

7.  Is it safe to train residents to perform cardiac surgery?

Authors:  Roger J F Baskett; Karen J Buth; Jean-Francois Legaré; Ansar Hassan; Camille Hancock Friesen; Gregory M Hirsch; David B Ross; John A Sullivan
Journal:  Ann Thorac Surg       Date:  2002-10       Impact factor: 4.330

8.  Open mesh versus laparoscopic mesh repair of inguinal hernia.

Authors:  Leigh Neumayer; Anita Giobbie-Hurder; Olga Jonasson; Robert Fitzgibbons; Dorothy Dunlop; James Gibbs; Domenic Reda; William Henderson
Journal:  N Engl J Med       Date:  2004-04-25       Impact factor: 91.245

9.  Surgical and oncology trials for rectal cancer: who will participate?

Authors:  James D Harrison; Michael J Solomon; Jane M Young; Alan Meagher; George Hruby; Glenn Salkeld; Stephen Clarke
Journal:  Surgery       Date:  2007-07       Impact factor: 3.982

10.  The challenges faced in the design, conduct and analysis of surgical randomised controlled trials.

Authors:  Jonathan A Cook
Journal:  Trials       Date:  2009-02-06       Impact factor: 2.279

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  164 in total

1.  [Contribution of the Study Center of the German Surgical Society to evidence based surgery].

Authors:  C Fink; T Keck; I Rossion; J Weitz; M K Diener; M W Büchler; P Knebel
Journal:  Chirurg       Date:  2011-12       Impact factor: 0.955

Review 2.  The Study Centre of the German Surgical Society: current trials and results.

Authors:  Phillip Knebel; Shafreena Kühn; Alexis B Ulrich; Markus W Büchler; Markus K Diener
Journal:  Langenbecks Arch Surg       Date:  2012-02-29       Impact factor: 3.445

3.  [Organization of clinical research: in general and visceral surgery].

Authors:  M Schneider; J Werner; J Weitz; M W Büchler
Journal:  Chirurg       Date:  2010-04       Impact factor: 0.955

4.  A call to the IDEAL.

Authors:  Andrew Graham
Journal:  Can J Surg       Date:  2010-06       Impact factor: 2.089

5.  Evaluation of postoperative pancreatic fistula after total gastrectomy with D2 lymphadenectomy by ISGPF classification.

Authors:  Yuichiro Miki; Masanori Tokunaga; Etsuro Bando; Yutaka Tanizawa; Taiichi Kawamura; Masanori Terashima
Journal:  J Gastrointest Surg       Date:  2011-08-11       Impact factor: 3.452

Review 6.  What can we learn from oncology surgical trials?

Authors:  Serge Evrard; Pippa McKelvie-Sebileau; Cornelis van de Velde; Bernard Nordlinger; Graeme Poston
Journal:  Nat Rev Clin Oncol       Date:  2015-10-20       Impact factor: 66.675

Review 7.  Quantification and comparison of neurosurgical approaches in the preclinical setting: literature review.

Authors:  F Doglietto; I Radovanovic; M Ravichandiran; A Agur; G Zadeh; J Qiu; W Kucharczyk; E Fernandez; M M Fontanella; F Gentili
Journal:  Neurosurg Rev       Date:  2016-01-19       Impact factor: 3.042

8.  Innovations in Endosurgery-Journey into the Past of the Future: To Ride the SILS Bandwagon or Not?

Authors:  Brij B Agarwal; Kamran Ali; Karan Goyal; Krishan C Mahajan
Journal:  Indian J Surg       Date:  2012-06-21       Impact factor: 0.656

9.  EAES recommendations on methodology of innovation management in endoscopic surgery.

Authors:  Edmund A M Neugebauer; Monika Becker; Gerhard F Buess; Alfred Cuschieri; Hans-Peter Dauben; Abe Fingerhut; Karl H Fuchs; Brigitte Habermalz; Leonid Lantsberg; Mario Morino; Stella Reiter-Theil; Gabriela Soskuty; Wolfgang Wayand; Thilo Welsch
Journal:  Surg Endosc       Date:  2010-01-07       Impact factor: 4.584

Review 10.  Surgical evaluation and knowledge transfer--methods of clinical research in surgery.

Authors:  Markus K Diener; Thomas Simon; Markus W Büchler; Christoph M Seiler
Journal:  Langenbecks Arch Surg       Date:  2011-03-22       Impact factor: 3.445

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