PMID- 36465024
OWN - NLM
STAT- MEDLINE
DCOM- 20230314
LR  - 20230318
IS  - 1399-0012 (Electronic)
IS  - 0902-0063 (Linking)
VI  - 37
IP  - 3
DP  - 2023 Mar
TI  - A viewpoint describing the American Society of Transplantation rationale to 
      conduct a comprehensive patient survey assessing unmet immunosuppressive therapy 
      needs.
PG  - e14876
LID - 10.1111/ctr.14876 [doi]
AB  - This viewpoint aims to "set the stage" and provide the rationale for the proposed 
      development of a large-scale, comprehensive survey assessing transplant patients' 
      perceived unmet immunosuppressive therapy needs. Research in organ 
      transplantation has historically focused on reducing the incidence and impact of 
      rejection on allograft survival and minimizing or eliminating the need for 
      chronic immunosuppressive therapies. There has been less emphasis and investment 
      in therapies to improve patient-reported outcomes including health-related 
      quality of life and side-effects. Patient-focused drug development (PFDD) is a 
      new and important emphasis of the Food and Drug Administration (FDA) that 
      provides a guiding philosophy for incorporating the patient experience into drug 
      development and evaluation. The American Society of Transplantation (AST) Board 
      of Directors commissioned this working group to prepare for the conduct of a 
      comprehensive patient survey assessing unmet immunosuppressive therapy needs. 
      This paper aims to describe the basis for why it is important to conduct this 
      survey and briefly outline the plan for broad stakeholder engagement to ensure 
      the information gained is diverse, inclusive, and relevant for advancing PFDD in 
      organ transplant recipients.
CI  - (c) 2022 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.
FAU - Taber, David J
AU  - Taber DJ
AUID- ORCID: 0000-0001-7273-4589
AD  - Department of Surgery, Medical University of South Carolina, Charleston, South 
      Carolina, USA.
FAU - Gordon, Elisa J
AU  - Gordon EJ
AUID- ORCID: 0000-0003-0969-1998
AD  - Department of Surgery, Vanderbilt University Medical Center, Nashville, 
      Tennessee, USA.
FAU - Jesse, Michelle T
AU  - Jesse MT
AUID- ORCID: 0000-0003-0847-0368
AD  - Henry Ford Transplant Institute, Internal Medicine, Henry Ford Health, Detroit, 
      Michigan, USA.
FAU - Myaskovsky, Larissa
AU  - Myaskovsky L
AUID- ORCID: 0000-0002-7268-1517
AD  - Center for Healthcare Equity in Kidney Disease and Department of Internal 
      Medicine, University of New Mexico, Health Sciences Center, Albuquerque, New 
      Mexico, USA.
FAU - Peipert, John Devin
AU  - Peipert JD
AUID- ORCID: 0000-0001-5762-7881
AD  - Department of Medical Social, Sciences & Northwestern University Transplant 
      Outcomes Research Collaboration, Northwestern University Feinberg School of 
      Medicine, Chicago, Illinois, USA.
FAU - Jaure, Allison
AU  - Jaure A
AUID- ORCID: 0000-0001-8973-9538
AD  - Sydney School of Public Health, The University of Sydney, Camperdown, Sydney, 
      Australia.
FAU - George, Roshan
AU  - George R
AUID- ORCID: 0000-0003-3853-967X
AD  - Emory University and Children's Healthcare of Atlanta, Atlanta, Georgia.
FAU - Fitzsimmons, William
AU  - Fitzsimmons W
AUID- ORCID: 0000-0002-6189-5499
AD  - Colleges of Pharmacy and Medicine, University of Illinois at Chicago, Chicago, 
      Illinois, USA.
CN  - American Society of Transplantation Board of Directors
LA  - eng
PT  - Journal Article
PT  - Research Support, Non-U.S. Gov't
DEP - 20221213
PL  - Denmark
TA  - Clin Transplant
JT  - Clinical transplantation
JID - 8710240
RN  - 0 (Immunosuppressive Agents)
SB  - IM
MH  - Humans
MH  - United States
MH  - *Immunosuppressive Agents/therapeutic use
MH  - Quality of Life
MH  - *Organ Transplantation
MH  - Immunosuppression Therapy
MH  - Surveys and Questionnaires
MH  - Graft Rejection/epidemiology
OTO - NOTNLM
OT  - patient characteristics
OT  - quality of life (QOL)
OT  - rejection
OT  - side effects
EDAT- 2022/12/06 06:00
MHDA- 2023/03/15 06:00
CRDT- 2022/12/05 03:32
PHST- 2022/11/22 00:00 [revised]
PHST- 2022/07/19 00:00 [received]
PHST- 2022/11/25 00:00 [accepted]
PHST- 2022/12/06 06:00 [pubmed]
PHST- 2023/03/15 06:00 [medline]
PHST- 2022/12/05 03:32 [entrez]
AID - 10.1111/ctr.14876 [doi]
PST - ppublish
SO  - Clin Transplant. 2023 Mar;37(3):e14876. doi: 10.1111/ctr.14876. Epub 2022 Dec 13.