Graft Versus Host Disease Clinical Trials: Is it Time for Patients Centered Outcomes to Be the Primary Objective? View Full Text


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Article Info

DATE

2019-02

AUTHORS

Bronwen E. Shaw

ABSTRACT

PURPOSE OF REVIEW: Graft versus host disease (GVHD) is a common complication following hematopoietic cell transplant and is associated with a high symptom burden, reduced functional status, and impaired quality of life (QOL). QOL is best assessed by patient-reported outcomes (PRO). Numerous clinical trials for the prevention and treatment of GVHD are available. This review aims to understand the landscape of PRO inclusion in clinical trials for GVHD over the last decade. RECENT FINDINGS: Consensus bodies, including experts in GVHD, PRO, and clinical trials have made recommendations for a standardized approach for the inclusion of PRO in clinical trials including as primary outcomes, however, these have yet to be implemented in a consistent manner in practice. Consistently applying consensus recommendation in chronic GVHD will ensure that PROs are appropriately included in clinical trials. Development of validated measures in acute GVHD and composite outcomes for all GVHD trials are required. More... »

PAGES

22-30

References to SciGraph publications

  • 2013-04. Topical thalidomide gel in oral chronic GVHD and role of in situ cytokine expression in monitoring biological activity in BONE MARROW TRANSPLANTATION
  • 2012-02. Response as an end point in treatment trials for acute GVHD in BONE MARROW TRANSPLANTATION
  • 2009-12. Skin response using NIH consensus criteria vs Hopkins scale in a phase II study for steroid-refractory chronic GVHD in BONE MARROW TRANSPLANTATION
  • 2011-11. Developing a Valid Patient‐Reported Outcome Measure in CLINICAL PHARMACOLOGY & THERAPEUTICS
  • 2011-06. Patterns of reporting health-related quality of life outcomes in randomized clinical trials: implications for clinicians and quality of life researchers in QUALITY OF LIFE RESEARCH
  • 2013-08. Measurement of oral chronic GVHD: results from the Chronic GVHD Consortium in BONE MARROW TRANSPLANTATION
  • 2016-09. Can we agree on patient-reported outcome measures for assessing hematopoietic cell transplantation patients? A study from the CIBMTR and BMT CTN in BONE MARROW TRANSPLANTATION
  • 1997-02. Quality of life measurement in bone marrow transplantation: development of the Functional Assessment of Cancer Therapy-Bone Marrow Transplant (FACT-BMT) scale in BONE MARROW TRANSPLANTATION
  • 2011-12. Development and preliminary testing of the new five-level version of EQ-5D (EQ-5D-5L) in QUALITY OF LIFE RESEARCH
  • 2018-06-05. EBMT−NIH−CIBMTR Task Force position statement on standardized terminology & guidance for graft-versus-host disease assessment in BONE MARROW TRANSPLANTATION
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1007/s11899-019-0494-x

    DOI

    http://dx.doi.org/10.1007/s11899-019-0494-x

    DIMENSIONS

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    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30637541


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    51 schema:description PURPOSE OF REVIEW: Graft versus host disease (GVHD) is a common complication following hematopoietic cell transplant and is associated with a high symptom burden, reduced functional status, and impaired quality of life (QOL). QOL is best assessed by patient-reported outcomes (PRO). Numerous clinical trials for the prevention and treatment of GVHD are available. This review aims to understand the landscape of PRO inclusion in clinical trials for GVHD over the last decade. RECENT FINDINGS: Consensus bodies, including experts in GVHD, PRO, and clinical trials have made recommendations for a standardized approach for the inclusion of PRO in clinical trials including as primary outcomes, however, these have yet to be implemented in a consistent manner in practice. Consistently applying consensus recommendation in chronic GVHD will ensure that PROs are appropriately included in clinical trials. Development of validated measures in acute GVHD and composite outcomes for all GVHD trials are required.
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