Connect MDS/AML: design of the myelodysplastic syndromes and acute myeloid leukemia disease registry, a prospective observational cohort study

Table 1 Information and assessments captured by the Connect MDS/AML Disease Registry

Type of Assessment	Variables
Baseline descriptions	• Patient eligibility • Patient demographics and medical history • Prior malignancies • ECOG performance status • Clinical frailty scale • Adult comorbidity evaluation (ACE-27) • Current and concomitant medications
Diagnostic patterns	• Central eligibility review results • Hematology/peripheral blood laboratory results • Bone marrow biopsies/aspirate reports • FISH analysis, flow cytometry, molecular analysis reports • MDS and AML diagnostic testing and prognostic classification^a
Treatment patterns	• Physician’s therapeutic objective • MDS and AML therapy, including supportive care • Changes in MDS and AML therapies • Transfusion information • Transplant eligibility and history • Select concomitant medications
Clinical outcomes	• Select chemistry laboratory results and other laboratory results • Response assessments • Survival information • Select AEs • Events of interest^b
HEOR and HRQOL	• Hospitalization (number, length of stay, treatments used, etc.) • Patient-reported HRQOL instruments

AE adverse event, AML acute myeloid leukemia, CNS central nervous system, ECOG Eastern Cooperative Oncology Group, FISH fluorescence in situ hybridization, HEOR health economics and outcomes research, HRQOL health-related quality of life, ICUS idiopathic cytopenia of undetermined significance, IPSS International Prognostic Scoring System, MDS myelodysplastic syndromes
^aFor MDS, IPSS is used for prognostication. For AML, both cytogenetic and molecular data are used for risk assessment
^bMDS: second primary malignancies; AML: extramedullary progression (including CNS) and second primary malignancies; ICUS: progression to MDS or AML

ISSN: 1471-2407