Literature DB >> 22583448

Beyond the FDA PRO guidance: steps toward integrating meaningful patient-reported outcomes into regulatory trials and US drug labels.

Ethan Basch.   

Abstract

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Year:  2012        PMID： 22583448     DOI： 10.1016/j.jval.2012.03.1385

Source DB:  PubMed          Journal:  Value Health        ISSN： 1098-3015            Impact factor:   5.725


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  19 in total

Review 1.  The level of association between functional performance status measures and patient-reported outcomes in cancer patients: a systematic review.

Authors:  Thomas M Atkinson; Charissa F Andreotti; Kailey E Roberts; Rebecca M Saracino; Marisol Hernandez; Ethan Basch
Journal:  Support Care Cancer       Date:  2015-08-28       Impact factor: 3.603

Review 2.  A systematic review of patient-reported outcome instruments of dermatologic adverse events associated with targeted cancer therapies.

Authors:  Alexandre Chan; Michael C Cameron; Benjamin Garden; Christine B Boers-Doets; Katja Schindler; Joel B Epstein; Jennifer Choi; Laura Beamer; Eric Roeland; Elvio G Russi; René-Jean Bensadoun; Yi Ling Teo; Raymond J Chan; Vivianne Shih; Jane Bryce; Judith Raber-Durlacher; Peter Arne Gerber; César O Freytes; Bernardo Rapoport; Nicole LeBoeuf; Vincent Sibaud; Mario E Lacouture
Journal:  Support Care Cancer       Date:  2015-01-07       Impact factor: 3.603

Review 3.  A literature synthesis of symptom prevalence and severity in persons receiving active cancer treatment.

Authors:  Carolyn Miller Reilly; Deborah Watkins Bruner; Sandra A Mitchell; Lori M Minasian; Ethan Basch; Amylou C Dueck; David Cella; Bryce B Reeve
Journal:  Support Care Cancer       Date:  2013-01-12       Impact factor: 3.603

4.  Exploring differences in adverse symptom event grading thresholds between clinicians and patients in the clinical trial setting.

Authors:  Thomas M Atkinson; Lauren J Rogak; Narre Heon; Sean J Ryan; Mary Shaw; Liora P Stark; Antonia V Bennett; Ethan Basch; Yuelin Li
Journal:  J Cancer Res Clin Oncol       Date:  2017-01-16       Impact factor: 4.553

5.  Cognitive testing of tobacco use items for administration to patients with cancer and cancer survivors in clinical research.

Authors:  Stephanie R Land; Graham W Warren; Jennifer L Crafts; Dorothy K Hatsukami; Jamie S Ostroff; Gordon B Willis; Veronica Y Chollette; Sandra A Mitchell; Jasmine N M Folz; James L Gulley; Eva Szabo; Thomas H Brandon; Sonia A Duffy; Benjamin A Toll
Journal:  Cancer       Date:  2016-03-28       Impact factor: 6.860

Review 6.  Patient-reported outcome measures in older people with hip fracture: a systematic review of quality and acceptability.

Authors:  K L Haywood; J Brett; E Tutton; S Staniszewska
Journal:  Qual Life Res       Date:  2016-10-20       Impact factor: 4.147

7.  Development and preliminary evaluation of a training workshop for the collection of patient-reported outcome (PRO) interview data by research support staff.

Authors:  Thomas M Atkinson; Karen Hurley; Carma L Bylund; Alexandra Berk; Kimberly Diminni; Jamie S Ostroff
Journal:  J Cancer Educ       Date:  2013-03       Impact factor: 2.037

Review 8.  Patient reported endpoints for measuring clinical benefit in (high grade glioma) primary brain tumor patients.

Authors:  Terri S Armstrong; Mark R Gilbert
Journal:  Curr Treat Options Oncol       Date:  2014-12

9.  Cognitive interviewing of the US National Cancer Institute's Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE).

Authors:  Jennifer L Hay; Thomas M Atkinson; Bryce B Reeve; Sandra A Mitchell; Tito R Mendoza; Gordon Willis; Lori M Minasian; Steven B Clauser; Andrea Denicoff; Ann O'Mara; Alice Chen; Antonia V Bennett; Diane B Paul; Joshua Gagne; Lauren Rogak; Laura Sit; Vish Viswanath; Deborah Schrag; Ethan Basch
Journal:  Qual Life Res       Date:  2013-07-20       Impact factor: 4.147

Review 10.  The association between clinician-based common terminology criteria for adverse events (CTCAE) and patient-reported outcomes (PRO): a systematic review.

Authors:  Thomas M Atkinson; Sean J Ryan; Antonia V Bennett; Angela M Stover; Rebecca M Saracino; Lauren J Rogak; Sarah T Jewell; Konstantina Matsoukas; Yuelin Li; Ethan Basch
Journal:  Support Care Cancer       Date:  2016-06-03       Impact factor: 3.603
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