Intrathecal Pump Refills at Home or at the Hospital

The McGill Quality of Life Questionnaire (MQOL) will measure quality of life and consists of 17 questions. Higher scores reflect a better quality of life.

The EuroQol with five dimensions and five levels (EQ-5D-5L) will be assessed to measure health-related quality of life. Higher scores reflect a better quality of life.

The Visual Analogue Scale (VAS - 100 mm) in electronic format will be used for the assessment of current pain intensity.

The NIH-funded Patient-Reported Outcomes Measurement Information System Pain Interference measure assesses the impact of pain on key aspects of an individual's life. It evaluates the extent to which pain disrupts engagement in social, cognitive, emotional, physical, and recreational activities.

Saliva samples will be collected to measure cortisol levels with synthetic salivettes.

Patient anxiety will be assessed through the State Trait Anxiety Inventory (STAI). This questionnaire consists of 40 Likert-type items on a four-point scale. Higher scores are indicating higher levels of anxiety.

The General Self-Efficacy (GSE) Scale is a 10-item self-report questionnaire used to assess perceived self-efficacy.

To evaluate caregiver burden, the Zarit Burden Interview (ZBI) questionnaire will be completed. This 12-item self-report instrument assesses caregiver burden and is a shortened version of the original 22-item Zarit Burden Scale. The total score ranges from 0 to 48, with higher totals reflecting more significant caregiver burden.

Patient satisfaction is evaluated with a seven-point Likert scale asking the patient to rate the overall level of satisfaction with the refill at home.

The quality of tele-monitoring will only be evaluated after a home-filling. This will be examined using three different Likert scales to score 1) quality of audio, 2) quality of video, and 3) overall quality of the teleconsultation.

The time required for the full procedure will be recorded.

Patients will evaluate the overall safety of the procedure 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.

Expenditures related to in hospital care will be extracted from hospital claims data. All other healthcare-related costs will be gathered through telephone interviews with patients, conducted four weeks after the first and second medication refills. During these calls, researchers will ask patients whether they have had any medical consultations, hospital admissions, adverse events, changes in medication, or incurred any additional healthcare costs.

After the fourth refill procedure, patients will be asked to indicate their preference (refill at home, refill in the hospital, no preference or other) for the location of their refills in the future.

After the fourth refill procedure, patients will be presented with a discrete choice experiment to evaluate their preferences across several scenarios.