Literature DB >> 21993428

The patient-reported outcome (PRO) consortium: filling measurement gaps for PRO end points to support labeling claims.

S J Coons1, S Kothari, B U Monz, L B Burke.   

Abstract

The importance of appropriately and effectively incorporating the patient's voice into the evaluation of new medical products has been recognized and affirmed by regulators.(1,2,3) Patient-reported outcomes (PROs) are increasingly being assessed in clinical trials to quantify treatment benefits such as symptom relief and improved functioning. Translating PRO-based treatment benefits into labeling claims can provide information to physicians and patients and assist in prescribing decisions.(4,5) Hence, standardizing the valid and reliable measurement of PRO end points is critical.

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Year:  2011        PMID： 21993428     DOI： 10.1038/clpt.2011.203

Source DB:  PubMed          Journal:  Clin Pharmacol Ther        ISSN： 0009-9236            Impact factor:   6.875


  24 in total

1.  Content Validity of the Lee Chronic Graft-versus-Host Disease Symptom Scale as Assessed by Cognitive Interviews.

Authors:  Emily C Merkel; Sandra A Mitchell; Stephanie J Lee
Journal:  Biol Blood Marrow Transplant       Date:  2016-01-02       Impact factor: 5.742

2.  Interpretation of verbal descriptors for response options commonly used in verbal rating scales in patient-reported outcome instruments.

Authors:  Alex Mutebi; Marion Slack; Terri L Warholak; Stacie Hudgens; Stephen Joel Coons
Journal:  Qual Life Res       Date:  2016-06-13       Impact factor: 4.147

Review 3.  Patient reported outcomes in rheumatoid arthritis clinical trials.

Authors:  Ana-Maria Orbai; Clifton O Bingham
Journal:  Curr Rheumatol Rep       Date:  2015-04       Impact factor: 4.592

Review 4.  What is the future of patient-reported outcomes in sickle-cell disease?

Authors:  Sharon A Singh; Nitya Bakshi; Prashant Mahajan; Claudia R Morris
Journal:  Expert Rev Hematol       Date:  2020-10-15       Impact factor: 2.929

5.  Exploration of oncologists' attitudes toward and perceived value of patient-reported outcomes.

Authors:  Michael L Meldahl; Sarah Acaster; Risa P Hayes
Journal:  Qual Life Res       Date:  2012-06-10       Impact factor: 4.147

6.  Item nonresponse on the Myeloproliferative Neoplasms Symptom Assessment Form (MPN-SAF): a comparison of missing data strategies.

Authors:  Gina L Mazza; Katie L Kunze; Blake T Langlais; Heidi E Kosiorek; Todd A DeWees; Holly L Geyer; Robyn M Scherber; Ruben A Mesa; Amylou C Dueck
Journal:  Leuk Lymphoma       Date:  2019-01-17

7.  Patient-Centered Research to Support the Development of the Symptoms of Major Depressive Disorder Scale (SMDDS): Initial Qualitative Research.

Authors:  Kelly P McCarrier; Linda S Deal; Lucy Abraham; Steven I Blum; Elizabeth Nicole Bush; Mona L Martin; Michael E Thase; Stephen Joel Coons
Journal:  Patient       Date:  2016-04       Impact factor: 3.883

8.  Development of a harmonized patient-reported outcome questionnaire to assess myelofibrosis symptoms in clinical trials.

Authors:  Chad Gwaltney; Jean Paty; Virginia E Kwitkowski; Ruben A Mesa; Amylou C Dueck; Elektra J Papadopoulos; Lixia Wang; Joseph Feliciano; Stephen Joel Coons
Journal:  Leuk Res       Date:  2017-05-12       Impact factor: 3.156

9.  Improvement in Patient-reported Hearing After Treatment With Bevacizumab in People With Neurofibromatosis Type 2.

Authors:  Victoria Huang; Amanda L Bergner; Chris Halpin; Vanessa L Merker; Monica R Sheridan; Brigitte C Widemann; Jaishri O Blakeley; Scott R Plotkin
Journal:  Otol Neurotol       Date:  2018-06       Impact factor: 2.311

10.  Qualitative Development and Content Validity of the Non-small Cell Lung Cancer Symptom Assessment Questionnaire (NSCLC-SAQ), A Patient-reported Outcome Instrument.

Authors:  Kelly P McCarrier; Thomas M Atkinson; Kendra P A DeBusk; Astra M Liepa; Michael Scanlon; Stephen Joel Coons
Journal:  Clin Ther       Date:  2016-04-01       Impact factor: 3.393
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