Initial Steps in Creating a Patient-Centric Addendum to Clinical Trial Informed Consent Forms

Autor: Bellinda L. King-Kallimanis, PhD, Andrea Ferris, MBA, Lisa Dropkin, BA, Mariel Molina, BS, Lydia Redway, BA, David E. Gerber, MD, Tracey L. Grant, MS, Upal Basu Roy, PhD

Publikováno v: JTO Clinical and Research Reports, Vol 4, Iss 10, Pp 100575- (2023)

Introduction: The purpose of the informed consent form (ICF) is to outline the risks and benefits of an interventional clinical trial to potential participants. The aim of this study was to explore the feasibility of a short addendum to the ICF, summ

Externí odkaz: https://doaj.org/article/eef9e7fd318843f9b76a9a9133843a9c

Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials: findings from an international, multidisciplinary working group

Autor: Claire Piccinin, Ethan Basch, Vishal Bhatnagar, Melanie Calvert, Alicyn Campbell, David Cella, Charles S Cleeland, Corneel Coens, Anne-Sophie Darlington, Amylou C Dueck, Mogens Groenvold, Ralf Herold, Bellinda L King-Kallimanis, Paul G Kluetz, Dagmara Kuliś, Daniel O'Connor, Kathy Oliver, Madeline Pe, Bryce B Reeve, Jaap C Reijneveld, Xin Shelley Wang, Andrew Bottomley

Publikováno v: Piccinin, C, Basch, E, Bhatnagar, V, Calvert, M, Campbell, A, Cella, D, Cleeland, C S, Coens, C, Darlington, A-S, Dueck, A C, Groenvold, M, Herold, R, King-Kallimanis, B L, Kluetz, P G, Kuliś, D, O'Connor, D, Oliver, K, Pe, M, Reeve, B B, Reijneveld, J C, Wang, X S & Bottomley, A 2023, ' Recommendations on the use of item libraries for patient-reported outcome measurement in oncology trials : findings from an international, multidisciplinary working group ', Lancet Oncology, vol. 24, no. 2, pp. e86-e95 . https://doi.org/10.1016/S1470-2045(22)00654-4

The use of item libraries for patient-reported outcome (PRO) measurement in oncology allows for the customisation of PRO assessment to measure key health-related quality of life concepts of relevance to the target population and intervention. However

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::6c74977cb245133c2e99aef4bb3cf15a
https://doi.org/10.1016/s1470-2045(22)00654-4

Timing is everything: The importance of patient-reported outcome assessment frequency when characterizing symptomatic adverse events

Autor: Bellinda L King-Kallimanis, Vishal Bhatnagar, Erica G Horodniceanu, Ting-Yu Chen, Paul G Kluetz

Publikováno v: Clinical Trials. 19:267-273

Objective Although patient-reported symptoms and side effects are increasingly measured in cancer clinical trials, an appropriate assessment frequency has not yet been established. To determine whether differences in assessment frequency affect the a

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0470ab6b60f291d269dd7b020351d0fb
https://doi.org/10.1177/17407745221093935

Best Practice Recommendations for Electronic Patient-Reported Outcome Dataset Structure and Standardization to Support Drug Development

Autor: Stacie Hudgens, Scottie Kern, Alexandra I. Barsdorf, Sally Cassells, Alison Rowe, Bellinda L. King-Kallimanis, Cheryl Coon, Geoff Low, Sonya Eremenco

Publikováno v: Value in Health.

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::a98039d9a95c1413fe79b6bdb84d6e13
https://doi.org/10.1016/j.jval.2023.02.011

Does Knowledge of Treatment Assignment Affect Patient Report of Symptoms, Function, and Health Status? An Evaluation Using Multiple Myeloma Trials

Autor: Paul G. Kluetz, Pallavi S. Mishra-Kalyani, Vishal Bhatnagar, Rajeshwari Sridhara, Jessica K Roydhouse, Roee Gutman, Bellinda L King-Kallimanis

Publikováno v: Value in Health. 24:822-829

Unblinded trials are common in oncology, but patient knowledge of treatment assignment may bias response to questionnaires. We sought to ascertain the extent of possible bias arising from patient knowledge of treatment assignment.This is a retrospect

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::98f3635314edca3aaa8f7293e924d1da
https://doi.org/10.1016/j.jval.2020.12.015