Patient Reported Outcome Measurements Registration in Spinal Pathologies and Neuromodulation

Patient Reported Outcome Measurements Registration in Spinal Pathologies and Neuromodulation: a Prospective Real-world Data Collection With Pre-determined Follow-up Moments

Longitudinal prospective observational data collection with questionnaires and categorical diagnostic and therapeutic registration and follow-up in spinal pathologies and neuromodulation

The primary aims of these projects are to:

• Start a longitudinal prospective observational data collection as a continuous and long-term control system for the outcome of spine related non-invasive and invasive interventions with pre-determined data collection moments. (The BIG DATA part)
• To create an overview of the patient flow within treatment modalities: to optimize the flow and combinations of treatment modalities to improve results (the FLOW part)
• To create patient profiles based on the PROMS per pathology and sub pathology (the PROFILING part)
• To optimize treatment strategies per patient based on their profile in order to create holistic responders (the HOLISTIC RESPONSE part)
• To share and publish the acquired information (the KNOWLEDGE part)

Secondary objectives:

• To collect high quality data on the population suffering from spinal diseases over time
• To collect high quality data on results of non-invasive treatments (nerve root blocks, transforaminal epidural steroid injections, facet joints treatments, physical therapy, ….) for spine related diseases
• To collect high quality data on results of invasive treatments for spine related diseases (radiofrequency therapies, surgery, instrumentated surgery)
• To collect high quality data on results of neuromodulation therapy (Spinal cord stimulation and DRG stimulation)
• To collect data at pre-determined follow-up moments and create a strict follow-up system to obtain longterm results
• To collect data on patient flow after a first invasive treatment and to perform post-hoc analysis in order to design patient-tailored post-intervention plans to increase outcome parameters
• To get insight into patient pain profiles and the adequate treatment options for these profiles
• To collect data on new treatment modalities after clinical implications
• To adjust treatment strategies and modalities in spine treatment in accordance with the results of the project data per continuum
• To monitor complications and analyze the origins of these complications and the adequate treatment and prevention
• To share the created data, experience and techniques with peers, trainees and health care professionals
• To obtain objective measurements for health-economical analysis 4. Study design 4.1 Statement of study design Longitudinal prospective observational cohort study. Dienst Neurochirurgie - Virga Jessa Ziekenhuis Version 4.0 16 April 2025 4.2 Subject groups The study will consist of every new patient and known patient treated in our association, unless patients do not agree to cooperate. 4.3 Study sites Patients will be recruited at the Jessa Hospital Hasselt, Sint-Franciscus Hospital HeusdenZolder, Sint-Trudo Ziekenhuis Sint-Truiden.

4.4 Number of subjects No target recruitment number has been set for the registry. We anticipate the inclusion of approximately 1000 - 1500 patients per year. 4.5 Sample size calculation and planned statistical analyses Sample size calculation has not been performed. Statistical tests will be performed by the study team. We expect a normal distribution of the data. We will apply an ANOVA test on the outcome of the parameters, corrected for multiple measurements. 4.6 Inclusion - exclusion criteria

Main criteria for inclusion:

1. Clinical diagnosis of spinal disease

2. Clinical indication to perform treatment of this disease

3. willing and capable to provide informed consent

4. Age ≥18 y

5. Subject procedures Data collection will be elementary and based on retrospective extraction from clinical record and of data which are part of a routinely clinically collection. No specific study interventions will be performed. No study-related imaging studies will be performed. Patients will be asked to fill-out specific patient-administered questionnaires in order to evaluate treatment results. Questionnaires will be provided digital, on an Ipad (provided by the neurochirurgy department during the study visit) with the back-app in a specific design for this study. If patients are not capable of using the Ipad, the study team will help them. If necessary, paper questionnaires can be provided and filled out in the eCRF afterwards by the study team. Patients who will participate will get an unique QR code per visit (valid for 24 hours) after identification. This QR code will directly take them to the questionnaires on the dedicated Ipad Dienst Neurochirurgie - Virga Jessa Ziekenhuis Version 4.0 17 April 2025 at our department. Participants will fill out one question per screen until the end of the questionnaires and data will be stored. The study team (study nurse or investigators) will fill out the stimulation related information on a desktop-based version of Back-app at the same visit in hospital. Nothing needs to be downloaded on a device of the patient and no patient's devices will be used. 5.1 Clinical The following broad categories of clinical data variable types will be prospectively collected from all enrolled patients through medical record and personal interview:

   • Baseline demographics e.g. age, gender, handedness.

   • Baseline socioeconomics e.g. education, employment, living situation, types of support.

   • Baseline medical history by system including substance abuse and prior surgeries and medications.

   • Symptoms, location, and other complaints

   • Results of medical imaging studies (MRI, CT, SPECT,…)

   • Results of neuro-physiological studies (EMG, SSEP,…..)

   • Hospital surgeries and neuromonitoring.

   • Reasons for clinical decisions

   • Physician based satisfaction with care and prognostic estimates

   • Admission and discharge dates and times throughout full clinical course.

   • Discharge destination and acute care outcome evaluation.

   • Complications during per- and post-operative period

   • Baseline results before the onset of treatment

   • Follow-up results at scheduled visits preferably at 6 weeks, 6 months (but not strictly planned) and once a year after treatment

   • Specific questionnaires to evaluate the results of treatment.

     • Visual analogue scale for pain
     • Pain Catastrophizing Scale
     • Pain Vigilance and Awareness Questionnaire
     • Oswestry Disability index
     • Eurocol 5d
     • Pain Detect Questionnaire
     • Patient Global Impression of Change (PGIC)

   • Physician input:

     • Categorical diagnosis (location of pain, duration, motoric deficit, etiology, duration, levels involved)
     • Patient Global Impression of Change (PGIC)
     • Next step (investigation, follow-up, treatment)
     • Pain medication (WHO classification)
     • Previous therapy categorical
     • Desired result of treatment (open question)
     • Neurmodulation programming parameters and electrode location (If applicable) Data will be entered by the patient an physician on dedicated devices and wirelessly transmitted to the database in a coded and secure way, to a secure database server located Dienst Neurochirurgie - Virga Jessa Ziekenhuis Version 4.0 18 April 2025 in Europe (Germany). All data handling will be in accordance with necessity for pseudoanonymous and anonymous handling.

6. Outcomes All outcomes will be registered in an online accessible database. The database will be accessible for the treating physicians only. Data can be extracted out of this database in an anonymous way to present to peers, medical health care professionals and third parties.

Outcomes may include but are not limited to:

• Treatment outcome on Visual analogue scale (VAS)
• Treatment outcomes on the ODI
• Treatment outcomes on the pain vigilance and awareness questionnaire
• Treatment outcomes on the pain catastrophizing scale
• Treatment outcomes on the EQ-5d
• Treatment outcomes for specific medical devices and comparison with other treatments
• Patients flow during the treatment of disease (for example: the effects of spinal injections, the amount of patients needing spine surgery and the results after spine surgery…)
• Treatment outcomes of specific surgical techniques (for example: less invasive techniques compared to open techniques,…..)

Inclusion Criteria:

1. Clinical diagnosis of spinal disease
2. Clinical indication to perform treatment of this disease
3. willing and capable to provide informed consent
4. Age ≥18 y

Exclusion Criteria:

not able to provide consent