Short summary

We will interview older patients with polypharmacy to explore what quality of life (QoL) means to them in relation to having medications deprescribed, and understand how QoL can best be captured in deprescribing trials from the perspective of the patients. We will also examine the face validity of selected QoL scales in a deprescribing context with these patients.

Rationale

Multimorbidity and polypharmacy can negatively impact older persons' function and ability to live according to their goals and expectations (i.e., impact their QoL). For example, taking many medications can be a lot of work for older persons and take time away from doing things they enjoy. By managing polypharmacy, deprescribing has been hypothesised to improve older people's QoL. Understanding the effect of deprescribing on QoL is therefore critical. One way to understand how deprescribing affects QoL is through conduct of deprescribing trials (prospective experimental studies of deprescribing interventions), in particular large-scale randomized controlled trials (RCTs). Measurement of patient-important outcomes such as QoL is a top priority for funders and policymakers from across the world.

As a core requirement for policy makers and other decision-makers responsible for commissioning health interventions, demonstrating QoL improvements in large-scale RCTs would pave the way for effective deprescribing interventions to be scaled up to improve well-being of older persons experiencing polypharmacy. This is supported by two relevant international Core Outcome Sets designating QoL a "core outcome measure" to collect when conducting deprescribing and polypharmacy management trials. Despite its importance, QoL is not always measured in deprescribing trials and when it is, a change/improvement is usually not demonstrated. This may be, in part, because it is unclear how QoL can be best captured in deprescribing research, for example, which QoL scales are most appropriate or which constructs/domains are most responsive to medication changes. Deprescribing researchers and trialists may also be hesitant to measure QoL due to practical concerns: it can be difficult, time-consuming, and expensive. Further, when QoL is measured, it is usually not a primary outcome, limiting the ability to detect an effect of deprescribing on QoL. To date, there has been little examination of how to practically measure QoL in deprescribing trials. To optimize and increase the measurement of QoL in deprescribing trials (and ultimately inform practice), we need to ensure we are measuring QoL efficiently and appropriately. Enhancing our approach for capturing QoL will be immensely useful in future large-scale deprescribing RCTs.

In this study, we will explore the patient perspective of measuring QoL in deprescribing trials.

Description of the cohort

We will conduct qualitative interviews followed by face validity testing of selected QoL scales. We will recruit about 30 older persons (≥65 years) with polypharmacy (≥5 regular medications) from Denmark, Canada and England (about 10 patients from each country). This OPEN registration concerns the Danish interviews. Patients will be recruited from the Geriatric Outpatient Clinic at Odense University Hospital.

Data and biological material

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Collaborating researchers and departments

Geriatric Department, Odense University Hospital

• Jesper Ryg (Professor, MD, PhD)

Hospital Pharmacy Funen, Odense University Hospital

• Trine Graabæk Hansen (Postdoc, MScPharm, PhD)