Immune thrombocytopenia (ITP) is an acquired autoimmune disorder defined by a platelet count < 100 × 109/L without explanation, and an increased risk of bleeding. ITP itself as well as its treatments have multifaceted, often poorly understood impacts on patients' quality of life (QoL). These effects include impact on activities of daily living, emotional health, energy, ability to think well and clearly, and productivity in the workplace. There are limited data on which individual aspects of ITP are perceived both by patients and physicians as having the greatest impact on QoL. Understanding patients' perspectives is vital to optimize their QoL by specifying particular areas in need of therapy.
I-WISh 1.0 was an exploratory, cross-sectional survey in which 1507 patients with ITP and 472 physicians across 13 countries completed separate, but related, online surveys that included assessments of ITP signs and symptoms, impact of symptoms, and patient-physician relationships. These findings have been presented at previous ASH and EHA congresses, and manuscripts are currently in preparation. However, although I-WISh 1.0 provided considerable insights into unexplored facets of the effects of ITP, an all-too-large number of gaps in understanding still remain. In response to this, I-WISh 2.0 is currently being developed.
The objectives of the I-WISh 2.0 patient and physician cross-sectional surveys include: (1) to further explore the burden of fatigue and how it affects patients' lives, including what makes it better or worse; (2) to assess the emotional impact of living with chronic ITP, especially in relation to depression; (3) to assess how treatments for ITP can impact activities of daily living (positively and negatively); (4) to further relate effects of treatment to patients' QoL; and (5) to explore how telemedicine affects healthcare delivery for patients with ITP. Furthermore, data from subsets of patients will address (6) the impact of COVID-19 in patients with ITP; and (7) special issues affecting ITP in pregnancy. A steering committee of ITP expert physicians and patient advocacy group representatives are designing and will endorse the patient and physician surveys now nearing readiness after several meetings to determine the areas of greatest need of assessment. In addition, a control group will be included.
Survey launch and data collection are scheduled to commence in early Q4 2020. Patients and physicians will complete similar online surveys. Both patient and physician surveys include a screener and sections of questions related to the specific objectives of I-WISh 2.0. The surveys include updates to key topics in I-WISh 1.0 (impact of fatigue, impact on daily life, treatment of ITP, emotional impact of ITP); validated patient-reported outcome tools to measure fatigue (MFIS-5), presence and severity of depression (PHQ-9), work-related burden (WPAI), and impact on quality of life (ILQI) tools; and questions related to COVID-19, telemedicine (remote patient monitoring), and pregnancy and ITP.
Patients will be recruited to I-WISh 2.0 via treating physicians and patient advocacy groups, and will be included if they are ≥ 18 years of age, diagnosed with ITP, and agree to participate. Participating physicians will be required to be actively managing patients with ITP and have a minimum caseload of 3 ITP patients currently under their care; physicians must also have a primary specialty of hematology or hematology-oncology. Approval will be sought from an independent centralized Institutional Review Board. Data analysis will be primarily descriptive and correlative in nature. Breakdown by country and geographic areas will be included.
A global sample is planned from 21 countries across 6 continents, with the aim of surveying more than 2000 patients and 600 physicians. I-WISh 2.0 will be the largest observational global survey ever conducted in ITP. If accepted, preliminary data are planned to be presented at the ASH meeting. I-WISh 2.0 will build on the strengths of I-WISh 1.0, which highlighted areas requiring further assessment and will explore aspects of ITP of great interest that were neither conclusively addressed in the first survey nor well-studied in the past.
Disclosures
Ghanima: Bristol Myers Squibb:Research Funding;Principia:Honoraria, Speakers Bureau;Pfizer:Honoraria, Research Funding, Speakers Bureau;Amgen:Honoraria, Speakers Bureau;Novartis:Honoraria, Speakers Bureau;Bayer:Research Funding.Provan:ONO Pharmaceutical:Consultancy;MedImmune:Consultancy;UCB:Consultancy;Amgen:Honoraria, Research Funding;Novartis:Honoraria, Research Funding.Cooper:Amgen:Honoraria, Speakers Bureau;Novartis:Honoraria, Speakers Bureau.Matzdorff:Roche Pharma AG:Other: Family stockownership;Amgen GmbH:Consultancy, Other: Honoraria paid to institution;Grifols Deutschland GmbH:Consultancy, Other: Honoraria paid to institution;Swedish Orphan Biovitrium GmbH:Consultancy, Other: Honoraria paid to institution;UCB Biopharma SRL:Consultancy, Other: Honoraria paid to institution;Novartis Oncology:Consultancy, Other: Honoraria paid to institution.Santoro:Novartis:Honoraria, Speakers Bureau;Takeda:Honoraria, Speakers Bureau;Amgen:Honoraria, Speakers Bureau;Novo Nordisk:Honoraria, Speakers Bureau;Bayer:Honoraria, Speakers Bureau;CSL Behring:Honoraria, Speakers Bureau;Roche:Honoraria, Speakers Bureau;Sobi:Honoraria, Speakers Bureau.Morgan:Sobi:Other: Consultancy fees paid to the ITP Support Association;UCB:Other: Consultancy fees paid to the ITP Support Association;Novartis:Other: Consultancy fees paid to the ITP Support Association.Kruse:Principia:Other: Grant paid to PDSA;Pfizer:Other: Grant and consultancy fee, all paid to PDSA;Argenx:Other: Grant paid to PDSA;Novartis:Other: PDSA received payment for recruiting patients to I-WISh and for promoting I-WISh on the globalitp.org website. Grant and consultancy fee, all paid to PDSA outside the submitted work;CSL Behring:Other: Grant paid to PDSA;UCB:Other: Grant and consultancy fee, all paid to PDSA;Rigel:Other: Grant paid to PDSA;Amgen:Other: Grant and honorarium, all paid to PDSA.Zaja:Janssen-Cilag:Honoraria, Speakers Bureau;Takeda:Honoraria, Speakers Bureau;Bristol Myers Squibb:Honoraria, Speakers Bureau;Grifols:Honoraria, Speakers Bureau;Amgen:Honoraria, Speakers Bureau;AbbVie:Honoraria, Speakers Bureau;Kyowa Kirin:Honoraria, Speakers Bureau;Mundipharma:Honoraria, Speakers Bureau;Novartis:Honoraria, Patents & Royalties: Pending patent (No. PAT058521) relating to TAPER trial (NCT03524612), Speakers Bureau;Roche:Honoraria, Speakers Bureau.Lahav:Novartis:Other: Consultancy fees paid to the Israeli ITP Support Association.Tomiyama:Novartis:Consultancy, Honoraria;Kyowa Kirin:Honoraria;Sysmex:Consultancy.Winograd:Novartis:Other: Consultancy fees paid to the Israeli ITP Support Association.Lovrencic:UCB:Other: Consultancy fees paid to AIPIT;Novartis:Other: Honorarium paid to AIPIT.Bailey:Adelphi Real World:Current Employment;Novartis:Other: Employee of Adelphi Real World, which has received consultancy fees from Novartis.Haenig:Novartis:Current Employment.Bussel:Novartis:Consultancy;Argenx:Consultancy;UCB:Consultancy;CSL Behring:Consultancy;Shionogi:Consultancy;Regeneron:Consultancy;3SBios:Consultancy;Dova:Consultancy;Principia:Consultancy;Rigel:Consultancy;Momenta:Consultancy;RallyBio:Consultancy;Amgen:Consultancy.
Anemia and functional capacity in elderly Brazilian hospitalized patients
