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The Development of a New Questionnaire to Measure the Burden of Immunoglobulin Treatment in Patients with Primary Immunodeficiencies: The IgBoT-35

Authors Jones GL, Williams K, Edmondson-Jones M, Prevot J, Drabwell J, Solis L, Shrimpton A, Mahlaoui N

Received 15 October 2019

Accepted for publication 12 June 2020

Published 3 September 2020 Volume 2020:14 Pages 1567—1584


Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 3

Editor who approved publication: Dr Johnny Chen

Georgina L Jones,1 Kate Williams,2 Mark Edmondson-Jones,2 Johan Prevot,3 Jose Drabwell,3 Leire Solis,3 Anna Shrimpton,4 Nizar Mahlaoui5– 7

1Department of Psychology, School of Social Sciences, Leeds Beckett University, Leeds, UK; 2PAREXEL International, London, UK; 3International Patient Organisation for Primary Immunodeficiencies, Downderry, Cornwall PL11 3LY, UK; 4Clinical Immunology and Allergy Unit, Northern General Hospital, Sheffield Teaching Hospitals and NHS Foundation Trust, Sheffield, UK; 5French National Reference Center for Primary Immune Deficiencies (CEREDIH), Necker Enfants Malades University Hospital, Assistance Publique-Hôpitaux De Paris, Paris, France; 6Pediatric Immuno-Haematology and Rheumatology Unit, Necker Enfants Malades University Hospital, Assistance Publique-Hôpitaux De Paris, Paris, France; 7IPOPI Medical Advisory Board, Chair

Correspondence: Georgina L Jones
Department of Psychology, School of Social Sciences, Leeds Beckett University, Calverley Building, City Campus, Leeds, UK
Tel +44 113 8125106

Purpose: To describe the development and psychometric testing of a new questionnaire to measure the burden of immunoglobulin treatment (Ig) from the perspective of patients with primary immunodeficiencies (PID).
Patients and Methods: An online, cross-sectional survey was administered to PID patients across 10 countries (nine European and Canada) who were receiving either intravenous (IVIg) or subcutaneous (SCIg) immunoglobulin therapy. The range and distribution of the responses (ie, levels of missing data, floor and ceiling effects), exploratory factor analysis (using factor loadings of 0.4 or greater) and measures of internal consistency reliability (ie, Cronbach’s alpha coefficient, inter-item and item-total correlations) were used to identify the domain and item pool.
Results: In total, 472 patients completed the questionnaire, of which 395 were included in the analysis (32% underwent IVIg and 67% underwent SCIg). The final instrument contained 34 items across eight domains of treatment burden (time, organisation and planning, leisure and social, interpersonal relationships, employment and education, travel, consequences of treatment and emotional) and an additional Ig treatment burden global question at the end of the measure. All the scales achieved good internal reliability (Cronbach’s alpha coefficient ranged from 0.70 to 0.85) and, with the exception of one item exceeded the minimum threshold of 0.35 for item-total correlations. Treatment burden was lower than anticipated across the different treatment routes and countries, although overall was more burdensome for patients undergoing IVIg compared to SCIg treatment.
Conclusion: The IgBoT-35 appears to be a reliable, patient-generated questionnaire and may help to identify more individualised and preferred therapies for the PID patient when used in clinical practice. A new survey with a sample of US patients is currently being undertaken to further establish its validity and conceptual model. The overall Ig burden of treatment scores appeared to be low. PID patient preferences are important to guide treatment decisions and ensuring patients receive the right treatment at the right time.

Keywords: intravenous immunoglobulins, subcutaneous immunoglobulins, primary immunodeficiency, treatment burden, patient preference, quality of life

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