Abstract
Introduction
NutriQoL® (Nestlé Health Science, Vevay, Switzerland) is a questionnaire developed to assess the health-related quality-of-life (HRQoL) of patients with home enteral nutrition (HEN) irrespective of their underlying condition and route of administration. The aim of this work is assessing the questionnaire’s reliability and responsiveness to change.
Methods
Two cohorts of patients with HEN and their primary caregivers were enrolled to assess reliability and responsiveness, respectively. All participants had to be 18 years of age or older, without mental deterioration (≤3 or 4 errors in the Pfeiffer’s test) and with sufficient functional status (>40 points on Karnovsky’s performance status scale). When the patients’ ability to respond to the questionnaire was impaired due to underlying disease, their caregivers answered on their behalf. NutriQoL was administered in two and three visits to reliability and responsiveness cohorts, respectively. Test–retest reliability and internal consistency were assessed by the intra-class correlation coefficient (ICC) and the Cronbach’s α, respectively. Responsiveness was evaluated by standardized effect size and standardized response mean between basal visit and third visit. Finally, the minimal clinically important difference (MCID) was estimated.
Results
A total of 54 and 86 participants were recruited to the reliability and responsiveness cohort, respectively. Thirty-five caregivers were selected to assess the inter-observer reliability. ICC values confirmed the good reproducibility level (ICC >0.75) of the questionnaire in both “physical functioning and activities of daily living” and “social life” domains and total score. The assessment of internal consistency in both domains of the questionnaire showed good internal consistency in visit 2. ICC showed the excellent agreement level between caregiver and patient in the global NutriQoL score. Finally, patients classified as having a minimal change in their health reported a mean (standard deviation) MCID in NutriQoL score of 0.63 (11.51).
Conclusion
NutriQoL is a reliable and unique instrument to measure the HRQoL in HEN patients. NutriQoL detects changes in the health status of the patient. Nevertheless, further research is needed to determine the full extent of the questionnaire responsiveness.
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Acknowledgments
Sponsorship and article processing charges for this study were funded by Nestlé Health Science, Barcelona, Spain.
Medical writing assistance for this study was provided by Outcomes’10, Castellón de la Plana, Spain, and funded by Nestlé Health Science, Barcelona, Spain.
All named authors meet the International Committee of Medical Journal Editors (ICMJE) criteria for authorship for this manuscript, take responsibility for the integrity of the work as a whole, and have given final approval for the version to be published.
Disclosures
Nestlé Health Science sponsored the study. The authors Maria Cristina Cuerda, Antonio Apezetxea, Lourdes Carrillo, Felipe Casanueva, Federico Cuesta, Jose Antonio Irles, and Maria Nuria Virgili state that they have no conflict of interest. Miquel Layola works at Nestlé Health Science. Luis Lizán works for an independent research organisation (Outcomes’10, S.L.) which has received fees for its contribution to the development and coordination of the original research project and to the writing of this manuscript.
Compliance with Ethics Guidelines
This study was performed according to the Code of Ethics of the World Medical Association (Declaration of Helsinki of 1964, as revised in 2013) and was approved by the Clinical Research Ethics Committee from the Hospital Clinic of Barcelona. All participants (patients and caregivers) gave their consent to participate in the study.
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Cuerda, M.C., Apezetxea, A., Carrillo, L. et al. Reliability and Responsiveness of NutriQoL® Questionnaire. Adv Ther 33, 1728–1739 (2016). https://doi.org/10.1007/s12325-016-0384-8
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DOI: https://doi.org/10.1007/s12325-016-0384-8