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51

Inclusion of patient-reported outcome measures in registered clinical trials: Evidence from ClinicalTrials.gov (2007–2013)

Vodicka, E., Kim, K., Devine, E.B., Gnanasakthy, A., Scoggins, J.F., Patrick, D.L.

Journal:

Contemporary Clinical Trials

Year:

2015

Language:

english

File:

PDF, 400 KB

english, 2015

52

Inclusion of Patient-Reported Outcome Measures In Registered Clinical Trials: Evidence From Clinicaltrials.Gov (2007-2013)

Vodicka, E., Kim, K., Devine, B., Gnanasakthy, A., Scoggins, J., Patrick, D.L.

Journal:

Value in Health

Year:

2015

Language:

english

File:

PDF, 68 KB

english, 2015

53

For Two Companies The Fda Pro Guidance Leads To Similar But Different Measures: A Case Study In Psoriasis

Mordin, M, Brown, TM, McLeod, L, DeMuro, C, Gnanasakthy, A

Journal:

Value in Health

Year:

2015

Language:

english

File:

PDF, 49 KB

english, 2015

54

Patient-Reported Outcomes in Latin America: Implementation in Research and Role in Emerging HTA Systems

Winnette, Randall, Zárate, Victor, Machnicki, Gerardo, DeMuro, Carla, Gawlicki, Mary, Gnanasakthy, Ari

Journal:

Value in Health Regional Issues

Year:

2015

Language:

english

File:

PDF, 777 KB

english, 2015

55

Benefits of patient-reported outcomes in Dermatology Drug Development

Copleymerriman, C., Zelt, S., Clark, M., Gnanasakthy, A.

Journal:

Value in Health

Year:

2015

Language:

english

File:

PDF, 50 KB

english, 2015

56

Considerations for Requiring Subjects to Provide a Response to Electronic Patient-Reported Outcome Instruments

O'Donohoe, P., Lundy, J. J., Gnanasakthy, A., Greene, A.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2015

Language:

english

File:

PDF, 103 KB

english, 2015

57

US FDA patient-reported outcome guidance: great expectations and unintended consequences

Fehnel, Sheri, DeMuro, Carla, McLeod, Lori, Coon, Cheryl, Gnanasakthy, Ari

Journal:

Expert Review of Pharmacoeconomics & Outcomes Research

Year:

2013

Language:

english

File:

PDF, 804 KB

english, 2013

58

Assessing Changes in Chronic Spontaneous/Idiopathic Urticaria: Comparisons of Patient-Reported Outcomes Using Latent Growth Modeling

Stull, Donald E., McBride, Doreen, Houghton, Katherine, Finlay, Andrew Y., Gnanasakthy, Ari, Balp, Maria-Magdalena

Journal:

Advances in Therapy

Year:

2016

Language:

english

File:

PDF, 1.00 MB

english, 2016

59

Overcoming Organizational Challenges of Integrating Patient-Reported Outcomes in Oncology Clinical Trials

Gnanasakthy, A., DeMuro, C.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2015

Language:

english

File:

PDF, 148 KB

english, 2015

60

Patient-Reported Outcomes in Cancer Drug Development and US Regulatory Review

Basch, Ethan, Geoghegan, Cindy, Coons, Stephen Joel, Gnanasakthy, Ari, Slagle, Ashley F., Papadopoulos, Elektra J., Kluetz, Paul G.

Journal:

Year:

2015

Language:

english

File:

PDF, 75 KB

english, 2015

61

Patient-Reported Outcomes Labeling for Products Approved by the Office of Hematology and Oncology Products of the US Food and Drug Administration (2010-2014)

Gnanasakthy, A., DeMuro, C., Clark, M., Haydysch, E., Ma, E., Bonthapally, V.

Journal:

Journal of Clinical Oncology

Year:

2016

Language:

english

File:

PDF, 531 KB

english, 2016

62

COMPARISON OF HOSPITAL COSTING METHODS IN AN ECONOMIC EVALUATION OF A MULTINATIONAL CLINICAL TRIAL

Reed, Shelby D., Friedman, Jolle Y., Gnanasakthy, Ari, Schulman, Kevin A.

Journal:

International Journal of Technology Assessment in Health Care

Year:

2003

Language:

english

File:

PDF, 201 KB

english, 2003

63

A Review Of Patient-Reported Outcome Orphan Drug Labels In The United States From January 2006-September 2013: Analysis Of Evidence For Orphan Drug Pro Label Claims

Clark, M., Simons, C., Haydysch, E., DeMuro, C., Gnanasakthy, A.

Journal:

Value in Health

Year:

2014

Language:

english

File:

PDF, 61 KB

english, 2014

64

Psychometric evaluation of the sporadic inclusion body myositis (sIBM) physical functioning assessment (sIFA)

Williams, V., Coles, T., DeMuro, C., Lewis, S., Williams, N., Yarr, S., Barghout, V., Lowes, L., Alfano, L., Goldberg, B., Gnanasakthy, A., Capkun, G., Tseng, B.

Journal:

Neuromuscular Disorders

Year:

2015

Language:

english

File:

PDF, 205 KB

english, 2015

65

A Novel Measure To Assess Self-Reported Physical Functioning In Patients With Sporadic Inclusion Body Myositis (Sibm)

DeMuro, C., Lewis, S., Pax Lowes, L., Alfano, L., Tseng, B., Gnanasakthy, A.

Journal:

Value in Health

Year:

2015

Language:

english

File:

PDF, 52 KB

english, 2015

66

Enoximone in Chronic Stable Angina: A Double-Blind Placebo-Controlled Cross-Over Trial

Dubrey, Simon W., Gnanasakthy, Ari, Stein, Wendy K., Song, Jie G., Hardman, Timothy, Hynd, John, Noble, Mark I. M.

Journal:

Journal of Cardiovascular Pharmacology

Year:

1994

File:

PDF, 620 KB

1994

67

OUTCOME ASSESSMENTS OF PRIMARY ENDPOINTS OF NEW DRUGS APPROVED BY THE FDA (2011-2015)

Gnanasakthy, A., DeMuro, C.

Journal:

Value in Health

Year:

2016

Language:

english

File:

PDF, 56 KB

english, 2016

68

FDA PATIENT-REPORTED OUTCOME LABELING OF NOVEL THERAPIES (2011-2015)

Gnanasakthy, A., Mordin, M., Haydysch, E., DeMuro, C.

Journal:

Value in Health

Year:

2016

Language:

english

File:

PDF, 85 KB

english, 2016

69

Patient Perceptions of Psoriasis: A Review of the Survey Literature by Geography

Mordin, M, Haydysch, E, Graham-Clarke, P, Gnanasakthy, A, Nikai, E

Journal:

Value in Health

Year:

2016

Language:

english

File:

PDF, 91 KB

english, 2016

70

Development Of A Disease Model For Sporadic Inclusion Body Myositis (Sibm)

Gnanasakthy, A., DeMuro, C., Lewis, S., Tseng, B.

Journal:

Value in Health

Year:

2015

Language:

english

File:

PDF, 67 KB

english, 2015

71

Development of the sporadic inclusion body myositis physical functioning assessment (sIFA)

DeMuro, Carla, Lewis, Sandy, Lowes, Linda, Alfano, Lindsay, Tseng, Brian, Gnanasakthy, Ari

Journal:

Year:

2016

Language:

english

File:

PDF, 836 KB

english, 2016

72

Psychometric validation of a patient-reported measure of physical functioning in sporadic inclusion body myositis

Williams, Valerie, Coles, Theresa, Gnanasakthy, Ari, DeMuro, Carla, Yarr, Stuart, Williams, Nicole, Lowes, Linda, Alfano, Lindsay, Tseng, Brian

Journal:

Year:

2016

Language:

english

File:

PDF, 788 KB

english, 2016

73

Psychometric validation of the Psoriasis Symptom Diary using Phase III study data from patients with chronic plaque psoriasis

Strober, Bruce, Zhao, Yang, Tran, Mary Helen, Gnanasakthy, Ari, Nyirady, Judit, Papavassilis, Charis, Nelson, Lauren M., McLeod, Lori D., Mordin, Margaret, Gottlieb, Alice B., Elewski, Boni E., Lebwoh

Journal:

International Journal of Dermatology

Year:

2016

Language:

english

File:

PDF, 334 KB

english, 2016

74

Documenting the Rationale and Psychometric Characteristics of Patient Reported Outcomes for Labeling and Promotional Claims: The PRO Evidence Dossier

Dennis A. Revicki, Ari Gnanasakthy and Kevin Weinfurt

Journal:

Quality of Life Research

Year:

2007

Language:

english

File:

PDF, 1.06 MB

english, 2007

75

Efficacy of Canakinumab vs. triamcinolone acetonide according to multiple gouty arthritis-related health outcomes measures

Hirsch, J. D., Gnanasakthy, A., Lale, R., Choi, K., Sarkin, A. J.

Journal:

International Journal of Clinical Practice

Year:

2014

Language:

english

File:

PDF, 222 KB

english, 2014

76

Abstracts: 9th Annual Conference of the International Society for Quality of Life Research (ISOQOL) || Cross-Cultural Validation of the Functional Assessment of Cancer Therapy for Patients Receiving Biologic Response Modifiers (FACT-BRM)

Stacie A. Hudgens, Elizabeth A. Hahn, Alastair Glendenning and Ari Gnanasakthy

Journal:

Quality of Life Research

Year:

2002

Language:

english

File:

PDF, 282 KB

english, 2002

77

Abstracts: 12th Annual Conference of the International Society for Quality of Life Research (ISOQOL) || P-40/1322/Determining the Minimum Important Difference (MID): A Possible Phenomenon in an Extreme Case

Cornelia Dunger-Baldauf, Guenter Rapatz, Erhard Quebe-Fehling, Verena Walter, Kathleen J. Yost, Ari Gnanasakthy and Michael Dolker

Journal:

Quality of Life Research

Year:

2005

Language:

english

File:

PDF, 336 KB

english, 2005

78

Abstracts: 9th Annual Conference of the International Society for Quality of Life Research (ISOQOL) || Comparing Methods for Treating Item-Level Missing Data

Kevin P. Weinfurt, Maren K. Olsen, Laura Coombs, Ari Gnanasakthy and Kevin A. Schulman

Journal:

Quality of Life Research

Year:

2002

Language:

english

File:

PDF, 282 KB

english, 2002

79

Impact of Measuring Patient-Reported Outcomes in Dermatology Drug Development

Copley-Merriman, Catherine, Zelt, Susan, Clark, Marci, Gnanasakthy, Ari

Journal:

The Patient: Patient-Centered Outcomes Research

Year:

2017

Language:

english

File:

PDF, 493 KB

english, 2017

80

A Review of Patient-Reported Outcome Labeling in the United States (2011–2015)

Gnanasakthy, Ari, Mordin, Margaret, Evans, Emily, Doward, Lynda, DeMuro, Carla

Journal:

Value in Health

Year:

2017

Language:

english

File:

PDF, 483 KB

english, 2017

81

Secukinumab sustains early patient-reported outcome benefits through 1 year: Results from 2 phase III randomized placebo-controlled clinical trials comparing secukinumab with etanercept

Strober, Bruce, Gottlieb, Alice B., Sherif, Bintu, Mollon, Patrick, Gilloteau, Isabelle, McLeod, Lori, Fox, Todd, Mordin, Margaret, Gnanasakthy, Ari, Papavassilis, Charis, Lebwohl, Mark G.

Journal:

Journal of the American Academy of Dermatology

Year:

2017

Language:

english

File:

PDF, 391 KB

english, 2017

82

Psoriasis patients with psoriasis Area and Severity Index (PASI) 90 response achieve greater health-related quality-of-life improvements than those with PASI 75–89 response: results from two phase 3 studies of secukinumab

Elewski, Boni E., Puig, Lluís, Mordin, Margaret, Gilloteau, Isabelle, Sherif, Bintu, Fox, Todd, Gnanasakthy, Ari, Papavassilis, Charis, Strober, Bruce E.

Journal:

Journal of Dermatological Treatment

Year:

2017

Language:

english

File:

PDF, 1.23 MB

english, 2017

83

Conceptual Model and Instrument Review in Multiple Sclerosis

Martin, SA, Olayinka-Amao, OC, Henke, C, Kamudoni, P, Gnanasakthy, A

Journal:

Value in Health

Year:

2017

Language:

english

File:

PDF, 77 KB

english, 2017

84

AB0504 Association between health-related quality of life (HRQOL) and ACR improvement among rheumatoid arthritis (RA) patients treated with secukinumab

Gnanasakthy, A., Kosinski, M., Genovese, M., Mallya, U., Mpofu, S.

Journal:

Annals of the Rheumatic Diseases

Year:

2013

Language:

english

File:

PDF, 48 KB

english, 2013

85

AB0505 Enhanced improvement in physical functioning with secukinumab treatment among RA patients: An application of IRT methodology

Gnanasakthy, A., Kosinski, M., Kellner, H., Mallya, U., Mpofu, S.

Journal:

Annals of the Rheumatic Diseases

Year:

2013

Language:

english

File:

PDF, 48 KB

english, 2013

86

AB0506 Enhanced improvement in fatigue from RA treatment with secukinumab: An application of IRT methodology

Gnanasakthy, A., Kosinski, M., Durez, P., Mallya, U., Mpofu, S.

Journal:

Annals of the Rheumatic Diseases

Year:

2013

Language:

english

File:

PDF, 49 KB

english, 2013

87

AB0507 Health-related quality of life (HRQOL) benefits associated with reductions in disease activity and pain severity among rheumatoid arthritis (RA) patients treated with secukinumab

Gnanasakthy, A., Kosinski, M., Genovese, M., Mallya, U., Mpofu, S.

Journal:

Annals of the Rheumatic Diseases

Year:

2013

Language:

english

File:

PDF, 49 KB

english, 2013

88

THU0328 Changes in health-related quality of life in systemic juvenile idiopathic arthritis patients after single dose of canakinumab

Wulffraat, N., Kallinich, T., McCann, L., Brik, R., Rutkowska-Sak, L., Ferrandiz, M., Lheritier, K., Kim, D., Gnanasakthy, A., Ozdogan, H.

Journal:

Annals of the Rheumatic Diseases

Year:

2013

Language:

english

File:

PDF, 179 KB

english, 2013

89

Measurement Equivalence of Patient-Reported Outcome Measures Migrated to Electronic Formats

Byrom, Bill, Gwaltney, Chad, Slagle, Ashley, Gnanasakthy, Ari, Muehlhausen, Willie

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2018

Language:

english

File:

PDF, 246 KB

english, 2018

90

Methods for Reporting the Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) Data in Cancer Clinical Trials

Zhou, X, Eid, D, Gnanasakthy, A

Journal:

Value in Health

Year:

2018

Language:

english

File:

PDF, 74 KB

english, 2018

91

Psychometric evaluation of the Sheehan Disability Scale in adult patients with attention-deficit/hyperactivity disorder

DeMuro, Carla, Cole, Theresa, Coon, Cheryl, McLeod, Lori, Gnanasakthy, Ari

Journal:

Neuropsychiatric Disease and Treatment

Year:

2014

Language:

english

File:

PDF, 583 KB

english, 2014

92

Patient-Reported Outcome Measures in Atopic Dermatitis and Chronic Hand Eczema in Adults

Barrett, Amy, Hahn-Pedersen, Julie, Kragh, Nana, Evans, Emily, Gnanasakthy, Ari

Journal:

The Patient: Patient-Centered Outcomes Research

Year:

2019

Language:

english

File:

PDF, 789 KB

english, 2019

93

PSY52 PATIENT-REPORTED OUTCOME MEASURES IN ATOPIC DERMATITIS AND CHRONIC HAND ECZEMA IN ADULTS

Barrett, A., Hahn-Pedersen, J., Kragh, N., Evans, E., Gnanasakthy, A.

Journal:

Value in Health

Year:

2019

File:

PDF, 385 KB

2019

94

Modelling seasonal effects in a new family of standard curves for the yields of milk, fat, protein and lactose in dairy cows.

Gnanasakthy, A., Morant, S.V.

Journal:

Proceedings of the British Society of Animal Production (1972)

Year:

1989

Language:

english

File:

PDF, 148 KB

english, 1989

95

PNS88 REVIEW OF PATIENT AND CLINICIAN GLOBAL ASSESSMENTS IN PRO LABELING (2017-2019)

Gnanasakthy, A., Barrett, A., D'Alessio, D., Norcross, L.

Journal:

Value in Health

Year:

2020

File:

PDF, 382 KB

2020