Validation Of a Comprehensive Health Status Assessment Scale In Older Patients (≥ 65 years) With Hematological Malignances. Gah Study
Authors: Bonanad Santiago , Persona Ernesto Perez , Oiartzabal Itziar , Gonzalez Bernardo , Fernandez-Lago Carlos , Zudaire Maria Teresa , Gironella Mercedes , Soler Alfonso , Valcarcel David , Hernández-Rivas Jose Ángel , Marrero Carmen , Arnan Montserrat , Olivier Carmen , Abrisqueta Pau , Xicoy Blanca , Sarrá Josep , Nomdedeu Benet , González Eva , Martinez Jesus , González-Campos José , Encinas Cristina , Laiglesia Almudena , Fernández-Maqueda Cristina , Jarque Isidro , Ferra Christelle , Falantes José , Carrillo Estrella , Muñoz Cristina , Feliú J , Durán Marta , Marcos Marina , López Silvia , Cruz-Jentoft Alfonso J , De La Rubia Javier 
Published: October 2019

Abstract

Background
Older patients are increasingly prevalent in oncological practice. However, the evidence suggests that this group of patients is undertreated, mainly because of their advanced age, regardless of whether they are highly functional patients, do not present comorbidities, or could benefit from oncological therapies. The US National Comprehensive Cancer Network and the International Society of Geriatric Oncology have recommended that some form of geriatric assessment should be conducted to help Hematologists and Oncologists in order to identify current health problems and to guide interventions to reduce adverse outcomes and optimize the functional status
Currently, the main tool for assessing older patients is a comprehensive geriatric assessment, although its complexity and duration may hinder its regular use in daily practice as a tool for clinical decision making. Several attempts have been made to assess comorbidities in the specific field of mielodysplasia, but mainly focused on organic damage rather than global assessment.

Aim
We are in the process of developing and validating a comprehensive health status assessment scale (Geriatric Assessment in Hematology, GAH Scale) with eight dimensions in patients ≥ 65 years with: Myelodysplastic syndromes (MDS), acute myeloblastic leukemia (AML) and multiple myeloma (MM).

Methods
After item-pool generation, stakeholder consultation and content validation, a brief scale of 8 dimensions with selected items has been created.
Feasibility was confirmed in 83 patients. Afterwards, a multicenter, observational, prospective study has been carried out in 20 hospitals in Spain, enrolling 189 elderly naïve to treatment patients with newly diagnosed MDS, AML or MM.
The scale validation process integrates the analysis of criterion and concept validity, internal consistency (Cronbach's alpha), test-retest reliability, as well as the evaluation of intraclass correlation coefficient (ICC) and factor analysis. After psychometric validation phase, further studies will be carried out in order to evaluate its clinical use for prognosis and clinical decision making.

Results
189 patients fulfilling inclusion criteria have been enrolled in the study, 54% women. Median age at diagnosis was 73.3 ± 6.64 years. According to diagnosis, 103 patients (54.5%) had MDS or AML and 86 (45.5%) had MM.
Regarding feasibility, mean time for filling in the questionnaire was 12.1 ± 4.5 min. 83.6% of patients answered 100% of questions of the scale. Mean percentage of unanswered questions per patient was 1%.
Test-retest was completed by 112 patients. GAH Scale showed satisfactory test-retest reliability. ICC was statistically significant for each dimension, being greater than 0.65 for 6 of the 8 dimensions (p<0.05), indicating that GAH Scale is independent of the observer and is stable in clinically stable patients along the time. Floor and ceiling effects were no detected.
Internal consistency, content validity and factor analysis are being carried out and results will be presented in the forthcoming congress.

Conclusion
This new GAH Scale is a valid, reliable and consistent tool, simple enough to assess health status in older patients with haematological malignancies. Further studies will have to stablish if it may be a tool to improve decision making in such patients.

Disclosures:
Bonanad: Celgene: Consultancy. Gonzalez:Celgene: Consultancy. Durán:Celgene: Employment. Marcos:Celgene: Employment. López:Celgene: Employment. Cruz-Jentoft:Celgene: Research Funding.