Background & Aims
A large variation exists in the monitoring of clinical outcome domains in patients with Persistent Spinal Pain Syndrome type 2 (PSPS-T2).1 This is partly because of the possible refractory character of this syndrome and the various clinical approaches and care pathways by different monodisciplinary medical specialties who are involved in the management of PSPS patients.2 Furthermore, it is unclear which outcome domains are deemed important from the PSPS-patient’s perspective. A standardized set of outcomes that focuses on biomedical, psychosocial, and behavioral domains is needed to map the impact on chronic pain patients.3 In a previous scoping review, we identified patient-relevant outcome domains.4 The objective of this study was to prioritize patient-relevant outcome domains for PSPS-type 2 to develop a core outcome set.
Methods
Four purposively sampled focus groups with patients with PSPS-T2 were conducted; two groups were composed of patients who were treated with spinal cord stimulation, and two groups of patients not eligible for spinal cord stimulation. Outcome domains identified in our scoping review and newly emerged domains were interactively discussed in detail with these groups. Next, outcome domains were prioritized using a Nominal Group Technique, where participants ranked the 5 most important outcome domains.5 The aggregated results from the ranking assignments were descriptively analyzed and a qualitative content analysis of the focus group discussions were performed to identify the final set of important outcome domains.5,6 Focus group sessions were audio-recorded, transcribed, and analyzed by two researchers.
Results
Thirty-four PSPS-T2 patients participated in the focus groups, of which 18 patients were already treated with Spinal Cord Stimulation. The mean age was 62 years (range 43–77; SD 8.1) and 35.3% of the participants were male. The average NRS scores were 5.6 (SD 2.7) for back pain and 6.2 (SD 2.6) for leg pain. The mean pain duration was 10.3 years (range 0–50; SD 14.2) for back pain and 10.3 years (range 3–50; SD 11.2) for leg pain. The ranking assignment was conducted by 33 participants. The five highest ranking outcome domains were ‘pain’, ‘daily activities’, ‘sleep’, ‘social participation’ and ‘self-reliance’. In the qualitative analysis, specific outcome domains emerged as prominent themes: ‘pain’, ‘physical activities’, ‘coping with the illness’, ‘acceptance’, and ‘social participation’. In addition, the participants expressed a desire for increased understanding, better acknowledgement, and gaining perspective during the care process.
Conclusions
The most important outcome domains for patients with PSPS-T2 are ‘pain’, ‘daily/physical activities’, ‘sleep’, ‘social participation’, ‘self-reliance’, ‘coping with the illness’ and ‘acceptance’. These outcome domains are recommended for inclusion in the healthcare evaluation of PSPS-T2 patients. These outcome domains can also be used for choice set experiments. More research with both patients and professionals is needed to determine adequate measurement tools related to the identified outcome domains, for the development of a core outcome set.
References
1.Cho, J. H., Lee, J. H., Song, K. S., Jae-Young, H., Yoon-Suk, J., Dong-Ho, L., … & Lee, C. S. (2017). Treatment outcomes for patients with failed back surgery. Pain physician, 20(1), E29.
2.Sebaaly, A., Lahoud, M. J., Rizkallah, M., Kreichati, G., & Kharrat, K., Etiology, evaluation, and treatment of failed back surgery syndrome. Asian spine journal, 2018. 12(3): p. 574.
3.Dansie, E.J., & Turk, D. C., Assessment of patients with chronic pain. British journal of anaesthesia, 2013. 111(1): p. 19-25.
4.Bastiaens, F., Wegener, J.T., Ostelo, R. W. J. G., van Roosendaal, B. K. W. P., Vissers, K. C. P., van Hooff, M. L. (2024). Clinical patient relevant outcome domains for Persistent Spinal Pain Syndrome: A Scoping Review and Expert Panels. (submitted)
5.McMillan, S. S., Kelly, F., Sav, A., Kendall, E., King, M. A., Whitty, J. A., & Wheeler, A. J. (2014). Using the nominal group technique: how to analyse across multiple groups. Health Services and Outcomes Research Methodology, 14, 92-108.
6.Rabiee, F. (2004). Focus-group interview and data analysis. Proceedings of the nutrition society, 63(4), 655-660.
Presenting Author
Jessica Wegener
Poster Authors
Ferdinand Bastiaens
MSc
Sint Maartenskliniek, Nijmegen
Lead Author
Jessica Wegener
MD
Sint Maartenskliniek, Nijmegen
Lead Author
Johanna Vriezekolk
Sint Maartenskliniek
Lead Author
Kris Vissers
MD
Department of Anesthesiology, Pain and Palliative Medicine, Radboud University Medical Center
Lead Author
Miranda van Hooff
PhD
Sint Maartenskliniek, Nijmegen
Lead Author
Topics
- Assessment and Diagnosis