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Ibsen C.1,2, Schiøttz-Christensen B.3,4, Vinther Nielsen C.1,2, Hørder M.5, Maribo T.1,2
1Aarhus University, Department of Public Health, Section of Clinical Social Medicine and Rehabilitation, Aarhus C, Denmark, 2DEFACTUM, Central Denmark Region, Research, Aarhus C, Denmark, 3Spine Center of Southern Denmark, Middelfart, Denmark, 4University of Southern Denmark, Institute of Regional Health Research, Odense, Denmark, 5University of Southern Danmark, Institute of Public Health, Unit for Patient Perspective, Odense, Denmark
Background: Low back pain (LBP) is the leading contributor to years lived with disability. It is a complex biopsychosocial phenomenon where complete differential diagnosis and assessment is difficult and needs to be comprehensive. Therefore a biopsychosocial approach is recommended.
Substantial amount of work has already been performed in the field of LBP regarding the design of outcome metrics but there is still no consensus about sets of outcome measures. Clinicians and researchers have used well-validated patient-reported outcome (PRO) measures to assess functioning and disability. One of the challenges associated with the use of existing PRO's is the lack of standardization and terminology, making comparison of studies difficult. The World Health Organization (WHO) has developed the International Classification of Functioning, Disability and Health (ICF) to provide a common language and framework for addressing the impact of a given health condition on human functioning.
Substantial amount of work has already been performed in the field of LBP regarding the design of outcome metrics but there is still no consensus about sets of outcome measures. Clinicians and researchers have used well-validated patient-reported outcome (PRO) measures to assess functioning and disability. One of the challenges associated with the use of existing PRO's is the lack of standardization and terminology, making comparison of studies difficult. The World Health Organization (WHO) has developed the International Classification of Functioning, Disability and Health (ICF) to provide a common language and framework for addressing the impact of a given health condition on human functioning.
Purpose: To develop and evaluate a patient-reported outcome (PRO) instrument based on the International Classification of Functioning, Disability and Health (ICF) to assess functioning in patients with lumbar radicular pain.
Methods: The development of the PRO will be based on ICF Comprehensive Core Set for Low Back Pain and Rehabilitation Set and existing items from the The Patient-Reported Outcomes Measurement Information System (PROMIS®). The development process will be divided into five steps:
1. Linking PROMIS items to ICF to identify items that correspond to the ICF categories in the two core sets.
2. Develop new relevant items corresponding to the ICF categories that the PROMIS items do not cover
3. Engaging patients and clinicians in the development process by conducting focus groups with patients (n=16) and a workshop with clinicians (n=8).
4. Alfa test among the participating patients and clinicians.
5. Beta test among patients in the target population (n=100).
In both Alfa and Beta test face validity, construct- and content validity are tested.
Results: The linking results show that 89 % of the PROMIS items were successfully linked to ICF. PROMIS items cover 22 % of the two ICF core sets. In order to ensure full coverage of the ICF core sets new items will be developed within the framework of PROMIS methods and terminology and with inputs from patients. Further results will be presented at the congress.
Conclusion(s): A PRO instrument is developed to systematise and qualify the description on functioning among patients with lumbar radicular pain. The development process is in progress and next step is to engage patients and clinicians in the development process.
Implications: With development of this PRO instrument based on ICF and excising PROMIS items we want to qualify and systematise the description of functioning in patients with lumbar radicular pain. Further this study will provide important insight into engaging patients in development of a PRO instrument and the use of patients´ perspective in clinical decision making. Finally this study will introduce a new disease-specific instrument to asses functioning at individual level in patients with lumbar radicular pain.
Funding acknowledgements: This project is funded by:
- DEFACTUM, Central Denmark Region
- Spine Center of Southern Denmark
- Aarhus University
- Danish Health Authority
- The Danish Rheumatism Association
Topic: Disability & rehabilitation
Ethics approval: The study is approved by the Danish Data Protection Agency (Sagsnr. 1-16-02-477-16).
All authors, affiliations and abstracts have been published as submitted.
