Patient Experiences of Chronic Low Back Pain: Development of a Conceptual Model Based on a Targeted Literature Review and Qualitative Patient Interviews
Ekin Seçinti, Brittany Klooster, Rebecca Robinson, Madison C. Bernstein, Madeline Tallarico, Kaitlin Chatterton, Adriana Voci, Daniella Olonilua, Samantha R. Linton, Leighann Litcher‐Kelly, Marcia M. Mellado Lagarde, Linda A. Wietecha, John MarkmanABSTRACT
Purpose
Chronic low back pain (CLBP) is a persistent, debilitating condition. The United States (US) Food and Drug Administration Patient‐Focused Drug Development Guidance recommends using patient‐reported outcome (PRO) measures to assess pain and function in clinical trials and document content validity of the measures based on patient experience data. The objective of this study was to explore and document the patient experience of symptoms and health‐related quality of life (HRQoL) impacts of CLBP based on a targeted literature review (TLR) and qualitative patient interviews to facilitate future PRO validation studies.
Methods
A TLR of patient‐focused studies and qualitative interviews ( N = 30) with adults with CLBP in the US were conducted to document the patient perspective of CLBP symptoms and HRQoL impacts. Results were combined in a patient‐centred conceptual model.
Results
Merged results from the TLR and qualitative interviews demonstrated that adults with CLBP described highly impactful experiences of pain. The conceptual model grouped 16 symptom and 120 impact concepts. CLBP was described as commonly co‐occurring with numbness, muscle spasms, and stiffness. CLBP‐related HRQoL impacts included physical functioning, emotional functioning, adaptive behaviours, sleep, social functioning, household chores/responsibilities, and work/school.
Conclusion
The findings highlight the multidimensional burden of living with CLBP. The newly developed patient‐centred conceptual model may be used to explore the content validity of PRO measures and promote a robust understanding of the patient experience with CLBP. Findings suggest that utilising HRQoL endpoints and patient‐centred approaches in CLBP studies of novel therapies may be an important way to quantify meaningfully effective treatments.