Validity of the Patient Experiences and Satisfaction with Medications (PESaM) Questionnaire

Merel L. Kimman (), Marlies S. Wijsenbeek (), Sander M. J. van Kuijk (), Kioa L. Wijnsma (), Nicole C. A. J. van de Kar (), Marjolein Storm (), Xana Jaarsveld () and Carmen D. Dirksen ()
Additional contact information
Merel L. Kimman: Maastricht University Medical Centre
Marlies S. Wijsenbeek: University Hospital Rotterdam
Sander M. J. van Kuijk: Maastricht University Medical Centre
Kioa L. Wijnsma: Amalia Children’s Hospital
Nicole C. A. J. van de Kar: Amalia Children’s Hospital
Marjolein Storm: Kidney Patients Association
Xana Jaarsveld: Lung Foundation Netherlands
Carmen D. Dirksen: Maastricht University Medical Centre

The Patient: Patient-Centered Outcomes Research, 2019, vol. 12, issue 1, No 10, 149-162

Abstract: Abstract Background This study assessed the validity and reliability of the generic module of the recently developed Patient Experiences and Satisfaction with Medications (PESaM) questionnaire in a sample of patients in the Netherlands. Methods The generic module of the PESaM questionnaire consists of 18 items related to the domains effectiveness, side effects and ease of use of medications. It assesses patients’ experiences regarding the impact of the medication on daily life, health and satisfaction. In 2017, the PESaM questionnaire was sent out to idiopathic pulmonary fibrosis patients using pirfenidone or nintedanib, atypical haemolytic uraemic syndrome patients receiving eculizumab and patients using tacrolimus after kidney transplantation. Mean scores for each domain were calculated applying a scoring algorithm. Construct validity and reliability were assessed using recommended methods. Results 188 participants completed the generic module, of whom 48% used pirfenidone, 36% nintedanib, 11% tacrolimus and 5% eculizumab. The generic module has good structural properties. Internal consistency values of the domains were satisfactory (i.e. Cronbach’s coefficient alpha above 0.7). Confirmatory factor analysis provided further evidence for construct validity, with good convergent and discriminant validity. The PESaM questionnaire also showed different scores for patients using different medications, in line with expectations, and was therefore able to differentiate between patient groups. Test–retest reliability of the items and domains were rated as moderate to fair (i.e. intraclass coefficients ranged between 0.18 and 0.76). Conclusions The PESaM questionnaire is a unique patient-reported outcome measure evaluating patient experiences and satisfaction with medications. It has been developed in conjunction with patients, ensuring coverage of domains and issues relevant from the patient’s perspective. This study has shown promising validity of the generic module of the PESaM questionnaire. Further research is recommended to assess reliability in greater detail as well as the responsiveness of the measure. Trial registration The study is registered in The Netherlands National Trial Register (Trial Code 5860).

Date: 2019
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DOI: 10.1007/s40271-018-0340-6

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