Literature DB >> 33449513

Composite outcomes for pain clinical trials: considerations for design and interpretation.

Jennifer S Gewandter1, Michael P McDermott2, Scott Evans3, Nathaniel P Katz4,5, John D Markman6, Lee S Simon7, Dennis C Turk8, Robert H Dworkin1.   

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Year:  2021        PMID： 33449513      PMCID： PMC8991304          DOI： 10.1097/j.pain.0000000000002188

Source DB:  PubMed          Journal:  Pain        ISSN： 0304-3959            Impact factor:   7.926


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  22 in total

1.  Composite outcomes in randomized trials: greater precision but with greater uncertainty?

Authors:  Nick Freemantle; Melanie Calvert; John Wood; Joanne Eastaugh; Carl Griffin
Journal:  JAMA       Date:  2003-05-21       Impact factor: 56.272

Review 2.  Outcome variables for osteoarthritis clinical trials: The OMERACT-OARSI set of responder criteria.

Authors:  Thao Pham; Désirée Van Der Heijde; Marissa Lassere; Roy D Altman; Jennifer J Anderson; Nicholas Bellamy; Marc Hochberg; Lee Simon; Vibeke Strand; Thasia Woodworth; Maxime Dougados
Journal:  J Rheumatol       Date:  2003-07       Impact factor: 4.666

3.  Development of responder definitions for fibromyalgia clinical trials.

Authors:  Lesley M Arnold; David A Williams; James I Hudson; Susan A Martin; Daniel J Clauw; Leslie J Crofford; Fujun Wang; Birol Emir; Chinglin Lai; Rong Zablocki; Philip J Mease
Journal:  Arthritis Rheum       Date:  2012-03

4.  Measurement in clinical trials: a neglected issue for statisticians?

Authors:  Stephen Senn; Steven Julious
Journal:  Stat Med       Date:  2009-11-20       Impact factor: 2.373

5.  Development of a multiple sclerosis functional composite as a clinical trial outcome measure.

Authors:  G R Cutter; M L Baier; R A Rudick; D L Cookfair; J S Fischer; J Petkau; K Syndulko; B G Weinshenker; J P Antel; C Confavreux; G W Ellison; F Lublin; A E Miller; S M Rao; S Reingold; A Thompson; E Willoughby
Journal:  Brain       Date:  1999-05       Impact factor: 13.501

6.  Using Outcomes to Analyze Patients Rather than Patients to Analyze Outcomes: A Step toward Pragmatism in Benefit:risk Evaluation.

Authors:  Scott R Evans; Dean Follmann
Journal:  Stat Biopharm Res       Date:  2016-12-06       Impact factor: 1.452

Review 7.  A first step to assess harm and benefit in clinical trials in one scale.

Authors:  Maarten Boers; Peter Brooks; James F Fries; Lee S Simon; Vibeke Strand; Peter Tugwell
Journal:  J Clin Epidemiol       Date:  2009-10-01       Impact factor: 6.437

8.  American College of Rheumatology. Preliminary definition of improvement in rheumatoid arthritis.

Authors:  D T Felson; J J Anderson; M Boers; C Bombardier; D Furst; C Goldsmith; L M Katz; R Lightfoot; H Paulus; V Strand
Journal:  Arthritis Rheum       Date:  1995-06

9.  DELTA2 guidance on choosing the target difference and undertaking and reporting the sample size calculation for a randomised controlled trial.

Authors:  Jonathan A Cook; Steven A Julious; William Sones; Lisa V Hampson; Catherine Hewitt; Jesse A Berlin; Deborah Ashby; Richard Emsley; Dean A Fergusson; Stephen J Walters; Edward C F Wilson; Graeme MacLennan; Nigel Stallard; Joanne C Rothwell; Martin Bland; Louise Brown; Craig R Ramsay; Andrew Cook; David Armstrong; Doug Altman; Luke D Vale
Journal:  BMJ       Date:  2018-11-05

10.  Evaluation of composite responder outcomes of pain intensity and physical function in neuropathic pain clinical trials: an ACTTION individual patient data analysis.

Authors:  Kushang V Patel; Robert Allen; Laurie Burke; John T Farrar; Jennifer S Gewandter; Ian Gilron; Nathaniel P Katz; John D Markman; Scott F Marshall; Malca Resnick; Andrew S C Rice; Michael C Rowbotham; Shannon M Smith; Geertrui F Vanhove; Ajay D Wasan; Shuyu Zhang; Robert H Dworkin; Dennis C Turk
Journal:  Pain       Date:  2018-11       Impact factor: 7.926
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  5 in total

Review 1.  Benefit-risk assessment and reporting in clinical trials of chronic pain treatments: IMMPACT recommendations.

Authors:  Bethea A Kleykamp; Robert H Dworkin; Dennis C Turk; Zubin Bhagwagar; Penney Cowan; Christopher Eccleston; Susan S Ellenberg; Scott R Evans; John T Farrar; Roy L Freeman; Louis P Garrison; Jennifer S Gewandter; Veeraindar Goli; Smriti Iyengar; Alejandro R Jadad; Mark P Jensen; Roderick Junor; Nathaniel P Katz; J Patrick Kesslak; Ernest A Kopecky; Dmitri Lissin; John D Markman; Michael P McDermott; Philip J Mease; Alec B O'Connor; Kushang V Patel; Srinivasa N Raja; Michael C Rowbotham; Cristina Sampaio; Jasvinder A Singh; Ilona Steigerwald; Vibeke Strand; Leslie A Tive; Jeffrey Tobias; Ajay D Wasan; Hilary D Wilson
Journal:  Pain       Date:  2021-09-09       Impact factor: 7.926

2.  Research approaches for evaluating opioid sparing in clinical trials of acute and chronic pain treatments: Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials recommendations.

Authors:  Jennifer S Gewandter; Shannon M Smith; Robert H Dworkin; Dennis C Turk; Tong J Gan; Ian Gilron; Sharon Hertz; Nathaniel P Katz; John D Markman; Srinivasa N Raja; Michael C Rowbotham; Brett R Stacey; Eric C Strain; Denham S Ward; John T Farrar; Kurt Kroenke; James P Rathmell; Richard Rauck; Colville Brown; Penney Cowan; Robert R Edwards; James C Eisenach; McKenzie Ferguson; Roy Freeman; Roy Gray; Kathryn Giblin; Hanna Grol-Prokopczyk; Jennifer Haythornthwaite; Robert N Jamison; Marc Martel; Ewan McNicol; Michael L Oshinsky; Friedhelm Sandbrink; Joachim Scholz; Richard Scranton; Lee S Simon; Deborah Steiner; Kenneth Verburg; Ajay D Wasan; Kerry Wentworth
Journal:  Pain       Date:  2021-11-01       Impact factor: 7.926

3.  A 6-Month Home-Based Functional Electrical Stimulation Program for Foot Drop in a Post-Stroke Patient: Considerations on a Time Course Analysis of Walking Performance.

Authors:  Romain David; Maxime Billot; Etienne Ojardias; Bernard Parratte; Manuel Roulaud; Amine Ounajim; Frédéric Louis; Hachemi Meklat; Philippe Foucault; Christophe Lombard; Anne Jossart; Laura Mainini; Martin Lavallière; Lisa Goudman; Maarten Moens; Davy Laroche; Marjorie Salga; François Genêt; Jean-Christophe Daviet; Anaick Perrochon; Maxence Compagnat; Philippe Rigoard
Journal:  Int J Environ Res Public Health       Date:  2022-07-27       Impact factor: 4.614

4.  Combining Awake Anesthesia with Minimal Invasive Surgery Optimizes Intraoperative Surgical Spinal Cord Stimulation Lead Placement.

Authors:  Philippe Rigoard; Amine Ounajim; Lisa Goudman; Chantal Wood; Manuel Roulaud; Philippe Page; Bertille Lorgeoux; Sandrine Baron; Kevin Nivole; Mathilde Many; Emmanuel Cuny; Jimmy Voirin; Denys Fontaine; Sylvie Raoul; Patrick Mertens; Philippe Peruzzi; François Caire; Nadia Buisset; Romain David; Maarten Moens; Maxime Billot
Journal:  J Clin Med       Date:  2022-09-22       Impact factor: 4.964

5.  The effect of duloxetine on mechanistic pain profiles, cognitive factors and clinical pain in patients with painful knee osteoarthritis-A randomized, double-blind, placebo-controlled, crossover study.

Authors:  Kristian Kjaer-Staal Petersen; Asbjørn Mohr Drewes; Anne Estrup Olesen; Nadia Ammitzbøll; Davide Bertoli; Christina Brock; Lars Arendt-Nielsen
Journal:  Eur J Pain       Date:  2022-06-13       Impact factor: 3.651
  5 in total

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