EHA Library - The official digital education library of European Hematology Association (EHA)

PSYCHOMETRIC VALIDATION OF THE SF-36V2® HEALTH SURVEY IN AN AL AMYLOIDOSIS POPULATION
Author(s): ,
Michelle K White
Affiliations:
Optum,Lincoln, RI,United States
,
Martha Bayliss
Affiliations:
Optum,Lincoln, RI,United States
,
Kristen L McCausland
Affiliations:
Optum,Lincoln, RI,United States
Spencer Guthrie
Affiliations:
Prothena Biosciences Inc,South San Francisco, CA,United States
(Abstract release date: 05/19/16) EHA Library. Guthrie S. 06/09/16; 132990; E1441
Ms. Spencer Guthrie
Ms. Spencer Guthrie
Contributions
Abstract
Abstract: E1441

Type: Eposter Presentation

Background
Light chain (AL) amyloidosis, a rare protein misfolding disease, leads to deficits in health-related quality of life (HRQoL).  Patients with AL amyloidosis present with a wide variety of non-specific symptoms, organ involvement, and functional impairment. The SF-36v2® Health Survey (SF-36v2), a general HRQoL survey, has been used to quantify the impact of AL amyloidosis on HRQoL, though to-date there is no evidence of its psychometric validity for use with AL amyloidosis patients.  

Aims
To document the psychometric properties of the SF-36v2 among AL amyloidosis patients, including tests of data quality, scaling success, reliability, and validity. 

Methods
Adults (≥ 18 years old) with self-reported AL amyloidosis completed baseline (n=341) and one-month follow-up (n=252) surveys online to assess HRQoL, clinical and socio-demographic characteristics.  Data quality evaluation (DQE) checks included item and scale distributions and a response consistency index (RCI).  The online system did not allow out of range values or missing data. Scaling success was evaluated against assumptions of summated rating scales.  Internal consistency reliability used Cronbach’s α.  Test-retest reliability used intra-class correlations (ICC) between baseline and one-month follow-up scores among a stable disease subgroup (n=180).  Scale convergent and discriminant validity was tested and used correlations between scores from the SF-36v2, the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), Patient Global Assessment of Functioning (GAF), and other surveys.  Known-groups validity tests used ANOVA of scores across patient groups varying in disease severity (self-reported hematologic response status, and Patient Global Impression – Severity (PGI-S)). 

Results
DQE showed excellent response distribution and RCI (94.1%). Scale reliability (Cronbach's α ≥ 0.780 across all 8 domains) and test-retest reliability (ICC ≥ 0.731) were acceptable. Tests of summated rating scale assumptions were satisfactory. Scale convergent and discriminant validity showed strong correlations with conceptually related measures. Tests for known-groups validity showed that the mean scores for respondents with self-reported complete hematologic response or remission were significantly greater than scores for respondents with no response to treatment (p < 0.05 for all scores).  Similarly, mean scores were also significantly associated with responses to the PGI-S (p < 0.0001 for all scores). 

Conclusion
This study provided robust evidence of the psychometric properties of the SF-36v2 in a diverse sample of patients with AL amyloidosis.  Planned future analyses will assess responsiveness and confirm psychometric properties of the SF-36v2 in clinic-based samples of AL amyloidosis patients. Study supported by:  Prothena Biosciences Inc

Session topic: E-poster

Keyword(s): AL amyloidosis, Quality of life
Abstract: E1441

Type: Eposter Presentation

Background
Light chain (AL) amyloidosis, a rare protein misfolding disease, leads to deficits in health-related quality of life (HRQoL).  Patients with AL amyloidosis present with a wide variety of non-specific symptoms, organ involvement, and functional impairment. The SF-36v2® Health Survey (SF-36v2), a general HRQoL survey, has been used to quantify the impact of AL amyloidosis on HRQoL, though to-date there is no evidence of its psychometric validity for use with AL amyloidosis patients.  

Aims
To document the psychometric properties of the SF-36v2 among AL amyloidosis patients, including tests of data quality, scaling success, reliability, and validity. 

Methods
Adults (≥ 18 years old) with self-reported AL amyloidosis completed baseline (n=341) and one-month follow-up (n=252) surveys online to assess HRQoL, clinical and socio-demographic characteristics.  Data quality evaluation (DQE) checks included item and scale distributions and a response consistency index (RCI).  The online system did not allow out of range values or missing data. Scaling success was evaluated against assumptions of summated rating scales.  Internal consistency reliability used Cronbach’s α.  Test-retest reliability used intra-class correlations (ICC) between baseline and one-month follow-up scores among a stable disease subgroup (n=180).  Scale convergent and discriminant validity was tested and used correlations between scores from the SF-36v2, the Kansas City Cardiomyopathy Questionnaire (KCCQ-12), Patient Global Assessment of Functioning (GAF), and other surveys.  Known-groups validity tests used ANOVA of scores across patient groups varying in disease severity (self-reported hematologic response status, and Patient Global Impression – Severity (PGI-S)). 

Results
DQE showed excellent response distribution and RCI (94.1%). Scale reliability (Cronbach's α ≥ 0.780 across all 8 domains) and test-retest reliability (ICC ≥ 0.731) were acceptable. Tests of summated rating scale assumptions were satisfactory. Scale convergent and discriminant validity showed strong correlations with conceptually related measures. Tests for known-groups validity showed that the mean scores for respondents with self-reported complete hematologic response or remission were significantly greater than scores for respondents with no response to treatment (p < 0.05 for all scores).  Similarly, mean scores were also significantly associated with responses to the PGI-S (p < 0.0001 for all scores). 

Conclusion
This study provided robust evidence of the psychometric properties of the SF-36v2 in a diverse sample of patients with AL amyloidosis.  Planned future analyses will assess responsiveness and confirm psychometric properties of the SF-36v2 in clinic-based samples of AL amyloidosis patients. Study supported by:  Prothena Biosciences Inc

Session topic: E-poster

Keyword(s): AL amyloidosis, Quality of life

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