Intrathecal pump refills at home or at the hospital

Approved 03/09/2025, UZ Brussel/VUB (Laarbeeklaan 101, Jette, 1090, Belgium; +32 24774111; ethiek@uzbrussel.be), ref: 1432025000188

1. Patient Comfort measured using General Comfort Questionnaire (GCQ) at at baseline and after each of the four refill procedures (postprocedural) through study completion

1. Quality of life measured using the McGill Quality of Life Questionnaire (MQOL) at at baseline and after each of the four refill procedures (postprocedural) through study completion
2. Health-related quality of life measured using the EuroQol with five dimensions and five levels (EQ-5D-5L) at at baseline and after each of the four refill procedures (postprocedural) through study completion
3. Pain intensity measured using the Visual Analogue Scale (VAS - 100 mm) in electronic format at at baseline and after each of the four refill procedures (postprocedural) through study completion
4. Pain interference in social, cognitive, emotional, physical, and recreational activities measured using the NIH-funded Patient-Reported Outcomes Measurement Information System Pain Interference measure at at baseline and after each of the four refill procedures (postprocedural) through study completion
5. Stress measured using Saliva samples will be collected to measure cortisol levels with synthetic salivettes at 5 minutes before the refill, immediately after the refill and 10 minutes after the refill procedure.
6. Anxiety measured using the State Trait Anxiety Inventory (STAI). at at baseline and after each of the four refill procedures (postprocedural) through study completion
7. Self-efficacy measured using the General Self-Efficacy (GSE) Scale at at baseline and after each of the four refill procedures (postprocedural) through study completion
8. Caregiver burden measured using the Zarit Burden Interview (ZBI) questionnaire at at baseline and after each of the four refill procedures (postprocedural) through study completion
9. Patient satisfaction measured using seven-point Likert scale at after each of the four refill procedures (postprocedural) through study completion
10. Tele-monitoring quality measured using using three different Likert scales to score 1) quality of audio, 2) quality of video, and 3) overall quality of the teleconsultation at after each refill procedure at home (2 times)
11. Duration of refill measured using stopwatch at during each refill procedure (4 times)
12. Patients will evaluate the overall safety of the procedure measured using a seven-point Likert scale. In addition, the researcher will assess safety on three levels: (1) overall perceived safety of the procedure using a seven-point Likert scale; (2) environmental safety, assessed through an open-ended question addressing any situations perceived as unsafe; and (3) the ability to perform the procedure in a clean and sterile manner, also evaluated via an open-ended question. at during and after each refill procedure (4 times)
13. Health expenditure measured using hospital claims data. All other healthcare-related costs will be gathered through telephone interviews with patients at four weeks after first refill and four weeks after second refill procedure.
14. Patient preference measured using by asking patients to indicate their preference (refill at home, refill in the hospital, no preference or other) for the location of their refills in the future at after the fourth refill procedure at study completion
15. Preferences across several scenarios measured using a discrete choice experiment at after the fourth refill procedure at study completion