Paper and electronic versions of HM-PRO, a novel patient-reported outcome measure for hematology: an equivalence study.

Pushpendra Goswami,Roger Else,Jack Lyness,Esther N Oliva,Sam Salek,Marina Karakantza,Jonathan Kell,Metod Oblak,Magda Jabbar Al-Obaidi,Saad Al-Ismail,Graham P Collins,Stewart Mcconnell,Adele K Fielding,Catherine Langton,Daniel M Jennings,Tatyana Ionova

doi:10.2217/cer-2018-0108

Abstract

Aim: To determine measurement equivalence of paper and electronic application of the hematological malignancy-patient-reported outcome (HM-PRO), a specific measure for the evaluation of patient-reported outcomes in HMs. Patients & methods: Following International Society of Pharmacoeconomics and Outcomes Research ePRO Good Research Practice Task Force guidelines, a total of 193 adult patients with different HMs were recruited into a multicenter prospective study. The paper and the electronic version of the instrument were completed in the outpatient clinics in a randomized crossover design with a 30 min time interval to minimize the learning effect. Those who completed the paper version first, completed the electronic version after 30min and vice versa. Instrument version and order effects were tested on total score of the two parts of the HM-PRO (Part A: quality of life and Part B: signs & symptoms) in a two-way ANOVA with patients as random effects. Intraclass correlation coefficients (95% CI) and Spearman's rank correlation coefficients were used to evaluate test-retest reliability and reproducibility. The effects of instrument version and order were tested on total score of the two parts of HM-PRO. Results: The questionnaire version and administration order effects were not significant at the 5% level. There were no interactions found between these two factors for HM-PRO (Part A [quality of life]; p =0.95); and (part B [signs and symptoms]; p =0.72]. Spearman's rank correlation coefficients were greater than 0.9, and intraclass correlation coefficients ranged from 0.94 to 0.98; furthermore, the scores were not statistically different between the two versions, showing acceptable reliability indexes. Noteworthy, the difference between the completion time for both paper (mean = 6:38min) and electronic version (mean = 7:29min) was not statistically significant (n=100; p =0.11). Patients did not report any difficulty in completing the electronic version during cognitive interviews and were able to understand and respond spontaneously. Conclusion: Measurement equivalence has been demonstrated for the paper and electronic application of the HM-PRO.

Highlights

According to the International Society of Pharmacoeconomics and Outcomes Research (ISPOR) ePRO Good Research Practice Task Force report [9], adapted from Shields et al [16], the rationale of a minor change is that ‘the modification can be justified on the basis of logic and/or existing literature
The only difference in the electronic version is that the items are presented by one domain per a page, which is under the definition of the ‘minor changes’ according to the ePRO task force report
The findings suggest that the electronic version of the hematological malignancy-patient-reported outcome (HM-Patient-reported outcome (PRO)) fulfills the requirements of measurement equivalence with the paper version of the instrument

Summary

Objectives

To determine measurement equivalence of paper and electronic application of the hematological malignancy-patient-reported outcome (HM-PRO), a specific measure for the evaluation of patientreported outcomes in HMs. The aim of this study was to evaluate the psychometric properties of the electronic version of the HM-PRO, in particular, reliability and face validity, in order to demonstrate equivalence between paper and electronic version of the instrument

Methods

Results

Discussion

Conclusion