Short summary

Health-related quality of life (HRQOL) is one of the most important treatment outcomes for patients with high impact chronic pain (HICP). HRQOL can be measured using the 10-item PROMIS Global Health questionnaire (PROMIS-10) . This study aims to gain a deeper knowledge regarding: 1) how patients with HICP understand the construct of HRQOL, 2) how they interpret PROMIS-10, and 3) how they view important change in PROMIS-10. The study will collect data through 15-20 semi-structured interviews.

Rationale

Chronic pain (CP) represents a major worldwide public health problem with a negative economic impact on society, healthcare resources, and the individual's health-related quality of life (HRQOL). Today, the prevalence of patients living with CP is estimated to be around 20 percent of the Danish population. CP is a complex phenomenon involving biopsychosocial mechanisms interacting in complex ways, which contribute to individual differences in the experience of pain. High impact chronic pain (HICP) is a type of CP and is defined as persistent pain with substantial restriction of life activities lasting six months or more. A recent study found that approximately eight percent of the population experience HICP. Patients with HICP report worse HRQOL compared to patients with CP, and they use healthcare services more frequently. These patients will often be recommended interdisciplinary biopsychosocial treatment in specialized pain clinics. Several pain clinics exist in Denmark, including the Pain Center at Odense University Hospital, where one of the main goals is to improve the patient's HRQOL. HRQOL is one of the most important treatment outcomes for patients with CP. HRQOL is a measure that describes the connection between health and quality of life, and it is defined as a person's well-being and self-perceived function in social, mental, and physical domains of health. Measuring HRQOL outcomes can be done in a variety of ways, including Patient-Reported Outcome Measures (PRO-measures). PRO-measures compromise items to represent the concepts and outcomes most important to the target population. A frequently used PRO-measure is the 10-item PROMIS Global Health survey (PROMIS-10). It has been used to measure HRQOL in several chronic health conditions, in-cluding CP. When interpreting change scores in PRO-measures such as PROMIS-10, it is essential to establish im-portant change thresholds. Thresholds can be established by a variety of quantitative statistical methods, where qualitative methods are less frequently used. However, quantitative methods do not reveal whether the change is important for the patient. This can be done using qualitative methods that can explore the patient's perspective of PRO-measures. This includes what the patients perceive as an important change, what outcomes they find most important in PRO-measures and how much the different items in PRO-measures should change for the patients to find it relevant. While many PRO-measures have been implemented in several health systems, it remains unknown how HICP patients understand HRQOL. It is also unknown how patients with HICP interpret the items of the PROMIS-10 questionnaire and how much each item should change for them to find it important. This is important for prioritizing and improving both quality of care and outcomes. This project has three aims. 1) The first aim is to gain deeper knowledge of patients with HICP's understanding of the construct of HRQOL. 2) The second aim is to gain a deeper understanding of patients with HICP's interpretation and under-standing of the PROMIS-10 questionnaire. 3) The third aim is to gain deeper knowledge about how much the different items in the PROMIS-10 questionnaire should change for the patients to find it important change of HRQOL.

Description of the cohort

The participants eligible for participating in this project are all Danish-speaking patients aged ≥18 years with HICP referred to interdisciplinary pain treatment at Pain Center in Odense and Pain Center Middelfart. The study aims to include the patients before their enrollment for treatment at the Pain Centers. It is standard procedure at both Pain Centers that patients answer a questionnaire in the electronic pain registry, PainData, before they begin their treatment course. For this project, an additional question will be added to the questionnaire concerning the patient's consent to be contacted for an interview. Patients willing to participate will be contacted to arrange an appointment for the interview. Here, further information will be given, and informed consent obtained.

Data and biological material

The study will collect data through individual, face-to-face, semi-structured interviews.

Collaborating researchers and departments

Pain Center Middelfart, Middelfart Hospital

• Daniel Broholm, Ph.d-student and co-supervisor

Department of Psychology, University of Southern Denmark

• Sophie Lykkegaard Ravn, Associate Professor and co-supervisor

Department of Anaesthesiology and Intensive Care, University Hospital Odense

• Henrik Bjarke Vægter, Professor and supervisor