Patient Reported Outcomes and Patient Voice Among Patients Diagnosed With Low Risk Myelodysplastic Syndrome (LR-MDS) or Unexplained Anemia In Japan
This study will examine quality of life, experiences, and unmet needs among individuals diagnosed with Low Risk Myelodysplastic Syndrome who are erythropoietin stimulating agent naïve and non-transfusion dependent and among individuals with suspected myelodysplastic syndromes with unexplained anemia in Japan
∙ The inclusion criteria for the quantitative phase will include either 1 or 2 and all of 3-6:
• Low Risk Myelodysplastic Syndromes (LR MDS) erythropoietin stimulating agent (ESA) naïve non-transfusion dependent (NTD) patients: identified with confirmed via bone marrow aspirate and \< 5% blasts in bone marrow. Lower-risk is defined by International Prognostic Scoring System International Prognostic Scoring System (IPSS) or Revised International Prognostic Scoring System (IPSS-R), as follows:
‣ Very low, low, or intermediate-risk (score ≤ 3.5) as assessed by IPSS-R
⁃ Low or intermediate-1 (score ≤ 1) as assessed by IPSS
• Unexplained anemia with suspected MDS: identified anemia with general anemia (iron/vitamin deficiency, bleeding, renal, etc.) excluded
• Patients with Hb \< 9.5 g/dl.
• Patients who are ≥ 18 years of age at the time of signing the informed consent form.
• Patients who are able and willing to provide informed consent.
• Patients who are able to complete the protocol requirements.
∙ For the qualitative phase (approximately 10 participants), the inclusion criteria will also include:
∙ 1\. Patients with severity scores of moderate or greater on at least one Patient Global Impression-Severity (PGI-S) item.