Meaningful within-patient change for clinical outcome assessments: model-based approach versus cumulative distribution functions-Reference-Cited by-同舟云学术

Meaningful within-patient change for clinical outcome assessments: model-based approach versus cumulative distribution functions

Published:2023-11-20 Issue: Volume: Page:1-13
ISSN:1054-3406
Container-title:Journal of Biopharmaceutical Statistics
language:en
Short-container-title:Journal of Biopharmaceutical Statistics

Author:

Ren Jinma¹,Bushmakin Andrew G.²,Cislo Paul R.³,Abraham Lucy⁴,Cappelleri Joseph C.²,Dworkin Robert H.⁵,Farrar John T.⁶

Affiliation:

1. Statistical Research & Data Science Center, Pfizer Inc, Collegeville, Pennsylvania, USA

2. Statistical Research & Data Science Center, Pfizer Inc, Groton, Connecticut, USA

3. Statistical Research & Data Science Center, Pfizer Inc, New York, New York, USA

4. Global Access & Value, Pfizer Ltd, Tadworth, Kent, UK

5. Department of Anesthesiology and Perioperative Medicine, University of Rochester School of Medicine and Dentistry, Rochester, New York, USA

6. Center for Clinical Epidemiology and Biostatistics, University of Pennsylvania Perelman School of Medicine, Philadelphia, Pennsylvania, USA

Funder

Pfizer and Eli Lilly & Company

Publisher

Informa UK Limited

Subject

Pharmacology (medical),Pharmacology,Statistics and Probability

Link

https://www.tandfonline.com/doi/pdf/10.1080/10543406.2023.2281575

Reference27 articles.

1. Special Issue PRO-Analysis of Clinically Meaningful Change on Patient-Reported Outcomes: Renewed Insights About Covariate Adjustment

2. ClinicalTrials.gov. 2021. Efficacy and safety of a subcutaneous tanezumab titration dosing regimen in subjects with moderate to severe osteoarthritis of the hip or knee. Secondary Efficacy and Safety of a Subcutaneous Tanezumab Titration Dosing Regimen in Subjects with Moderate to Severe Osteoarthritis of the Hip or Knee. https://clinicaltrials.gov/ct2/show/NCT02697773.

3. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee

4. Interpreting Change in Scores on Patient-Reported Outcome Instruments

5. Moving from significance to real-world meaning: methods for interpreting change in clinical outcome assessment scores