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1

PMI8 VALIDATION OF COST ESTIMATION TECHNIQUE FOR HOSPITALIZATIONS FOR USE IN MULTINATIONAL ECONOMIC EVALUATIONS

SD Reed, JY Friedman, A Gnanasakthy, KA Schulman

Journal:

Value in Health

Year:

2002

Language:

english

File:

PDF, 78 KB

english, 2002

2

Conducting economic evaluations alongside multinational clinical trials: Toward a research consensus

Shelby D. Reed, Kevin J. Anstrom, Ameet Bakhai, Andrew H. Briggs, Robert M. Califf, David J. Cohen, Michael F. Drummond, Henry A. Glick, Ari Gnanasakthy, Mark A. Hlatky, Bernie J. O'Brien, Frank M. To

Journal:

American Heart Journal

Year:

2005

Language:

english

File:

PDF, 225 KB

english, 2005

3

Using patient- and clinician-rated anchors to evaluate change on the functional assessment of cancer therapy—biologic response modifiers

ElizabethA. Hahn, Ari Gnanasakthy, G.Alastair Glendenning, MarkV. Sorensen, Linda Odom, David Cella

Journal:

Clinical Therapeutics

Year:

2002

Language:

english

File:

PDF, 147 KB

english, 2002

4

PMC55 IMPACT OF THE FDA DRAFT GUIDANCE ON PATIENT REPORTED OUTCOMES (PRO) LABEL CLAIMS FOR APPROVED DRUG PRODUCTS IN THE US: HAS IT MADE A DIFFERENCE?

M Mordin, M Clark, C Siersma, K Copley-Merriman, A Gnanasakthy

Journal:

Value in Health

Year:

2009

Language:

english

File:

PDF, 87 KB

english, 2009

5

PHP1 Incorporating the Patient's Voice Into the Assessment of Medical Devices: A Comparison of the United States and Europe

L. Doward, D. Whalley, K. Houghton, C. DeMuro, E. Evans, A. Gnanasakthy

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 68 KB

english, 2012

6

PDB16 COST-EFFECTIVENESS OF BLOOD PRESSURE AND URINARY ALBUMIN CONTROL IN DIABETICS WITH AN ANGIOTENSIN II RECEPTOR ANTAGONIST AND A CALCIUM CHANNEL BLOCKER: PHARMACOECONOMIC ANALYSIS OF THE MARVAL TRIAL-THE CASE OF GERMANY

DG Smith, A Gnanasakthy, K Quednau

Journal:

Value in Health

Year:

2003

Language:

english

File:

PDF, 66 KB

english, 2003

7

PIH49 Patient Reported Outcomes as Primary Endpoints in Confirmatory Clinical Trials

Gnanasakthy, A., Lewis, S., Clark, M., Evans, E., Mordin, M., Demuro, C.

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 56 KB

english, 2012

8

Promotion of Patient-Reported Outcome Label Claims Based on Nonprimary Endpoints

Gnanasakthy, A., Sadrick, A., Eghbal-Ahmadi, M., DeMuro, C.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2014

Language:

english

File:

PDF, 298 KB

english, 2014

9

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

10

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

11

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

12

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

13

The effect of different rearing systems on the development of calf behaviour

A.J.F. Webster, C. Saville, B.M. Church, A. Gnanasakthy, R. Moss

Journal:

British Veterinary Journal

Year:

1985

Language:

english

File:

PDF, 778 KB

english, 1985

14

PHP182 Concordance of PRO Labeling Claims Between the FDA and EMA

A. Gnanasakthy, L. Doward, M. Clark, M. Mordin, C. Demuro

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 58 KB

english, 2012

15

PMC31 AT WHAT COST? A REVIEW OF DRUG ACQUISITION COST ISSUES IN MODELLED ECONOMIC EVALUATIONS.

M Wonder, M Backhouse, A Gnanasakthy

Journal:

Value in Health

Year:

2005

Language:

english

File:

PDF, 67 KB

english, 2005

16

Role of Patient-Reported Outcome Measures in the Assessment of Central Nervous System Agents

Gnanasakthy, A., DeMuro, C., Clark, M., Mordin, M., Thomas, S.

Journal:

Therapeutic Innovation & Regulatory Science

Year:

2013

Language:

english

File:

PDF, 131 KB

english, 2013

17

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

18

THE IMPACT OF HOSPITAL COSTING METHODS ON STATISTICAL POWER IN MULTINATIONAL CLINICAL TRIALS

Sd Reed, Jy Friedman, Jh Malenbaum, A Gnanasakthy, Ka Schulman

Journal:

Value in Health

Year:

2001

Language:

english

File:

PDF, 248 KB

english, 2001

19

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

20

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

21

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

22

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

23

ESTIMATING INCREMENTAL COSTS FOR ADDITIONAL HOSPITAL DAYS

Jy Friedman, Sd Reed, A Gnanasakthy, Ka Schulman

Journal:

Value in Health

Year:

2001

Language:

english

File:

PDF, 999 KB

english, 2001

24

PMC31 THE ROLE OF THE PATIENT VOICE IN HEALTH TECHNOLOGY ASSESSMENT

A Gnanasakthy, C DeMuro, M Mordin, K Copley-Merriman, J Mauskopf

Journal:

Value in Health

Year:

2010

Language:

english

File:

PDF, 68 KB

english, 2010

25

PMC31 CONTROLLING MEASUREMENT ERROR OF PATIENT-REPORTED-OUTCOMES DURING THE IMPLEMENTATION STAGE OF CLINICAL TRIALS

Journal:

Value in Health

Year:

2008

Language:

english

File:

PDF, 71 KB

english, 2008

26

ND2: POTENTIAL SAVINGS IN THE COST OF TREATING ALZHEIMER'S DISEASE: PATIENT TREATMENT WITH RIVASTIGMINE

AB Hauber, A Gnanasakthy, EH Snyder, A Richter, JA Mauskopf

Journal:

Value in Health

Year:

1999

Language:

english

File:

PDF, 50 KB

english, 1999

27

Secukinumab treatment in rheumatoid arthritis is associated with incremental benefit in the clinical outcomes and HRQoL improvements that exceed minimally important thresholds

Strand, Vibeke, Kosinski, Mark, Gnanasakthy, Ari, Mallya, Usha, Mpofu, Shephard

Journal:

Health and Quality of Life Outcomes

Year:

2014

Language:

english

File:

PDF, 209 KB

english, 2014

28

Multinational economic evaluation of valsartan in patients with chronic heart failure: results from the Valsartan Heart Failure Trial (Val-HeFT)

Shelby D Reed, Joëlle Y Friedman, Eric J Velazquez, Ari Gnanasakthy, Robert M Califf, Kevin A Schulman

Journal:

American Heart Journal

Year:

2004

Language:

english

File:

PDF, 159 KB

english, 2004

29

Savings in the cost of caring for patients with Alzheimer's disease in Canada: An analysis of treatment with rivastigmine

A. Brett Hauber, Ari Gnanasakthy, Josephine A. Mauskopf

Journal:

Clinical Therapeutics

Year:

2000

Language:

english

File:

PDF, 960 KB

english, 2000

30

Potential Savings in the Cost of Caring for Alzheimer’s Disease

A. Brett Hauber,Ari Gnanasakthy,Edward H. Snyder,Mohan V. Bala…

Journal:

PharmacoEconomics

Year:

2000

Language:

english

File:

PDF, 130 KB

english, 2000

31

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

32

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

33

Some effects of different rearing systems on health, cleanliness and injury in calves

A.J.F. Webster, C. Saville, B.M. Church, A. Gnanasakthy, R. Moss

Journal:

British Veterinary Journal

Year:

1985

Language:

english

File:

PDF, 580 KB

english, 1985

34

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

35

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

36

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

37

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

38

Using Multiple Anchor- and Distribution-Based Estimates to Evaluate Clinically Meaningful Change on the Functional Assessment of Cancer Therapy-Biologic Response Modifiers (FACT-BRM) Instrument

Kathleen J. Yost, Mark V. Sorensen, Elizabeth A. Hahn, G. Alastair Glendenning, Ari Gnanasakthy, David Cella

Journal:

Value in Health

Year:

2005

Language:

english

File:

PDF, 118 KB

english, 2005

39

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

40

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

41

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

42

PRM38 Validation of New Measures of Patients' Post-Transplant Experience in the Patientslikeme® Organ Transplant Community

M.P. Massagli, A. Gnanasakthy, P. Wicks

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 57 KB

english, 2012

43

PIH54 Promotion of Patient Reported Outcomes (PRO) Label Claims Based on Non-Primary Endpoints

Gnanasakthy, A., Sadrick, A., Demuro, C., Rahul, R.

Journal:

Value in Health

Year:

2012

Language:

english

File:

PDF, 56 KB

english, 2012

44

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

45

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

46

Patient reported outcomes: looking beyond the label claim

Lynda C Doward, Ari Gnanasakthy, Mary G Baker

Journal:

Health and Quality of Life Outcomes

Year:

2010

Language:

english

File:

PDF, 549 KB

english, 2010

47

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

48

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

49

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

50

Documenting the rationale and psychometric characteristics of patient reported outcomes for labeling and promotional claims: the PRO Evidence Dossier

Dennis A. Revicki, Ari Gnanasakthy, Kevin Weinfurt

Journal:

Quality of Life Research

Year:

2007

Language:

english

File:

PDF, 146 KB

english, 2007

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