UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
NCT Number: NCT04638894
The study will examine if variability in created value (outcome/costs) over the care cycle for ASD patients can be explained by patient and treatment characteristics.
This study is active but is not currently recruiting participants.
18 year and older
All sexes
Observational
Leuven, Vlaams-Brabant, 3000, Belgium
Due to budget restrictions in health care, cost is a major challenge, particularly in chronic disorders affecting the ageing population for which advanced but often expensive medical technologies offer benefit. Stakeholders strive to define, assess and improve the so-called "value in healthcare" to achieve the best outcome at the lowest cost of care.
First and foremost, the investigator will try to examine if we can explain variability in the created value over the care cycle by patient and treatment characteristics. This knowledge can be used to optimize the value for the patients. Also, the investigator will try to compare the psychometric properties between the different versions of value equations, resulting from the use of different outcome tools to measure value.
Adult Spinal Deformity patients can take part in the study. This will be decided by clinical examination and radiographic evaluation and is based on at least one of the following criteria: 1) Coronal spinal curvature ≥20°, 2)Sagittal vertical axis (SVA) >5 cm, 3) Pelvic tilt >25°, 4) Thoracic kyphosis >60°. The patients have to be older than or equal to 18 years old at the time of surgery.
In line with the standard of care, the patients will be seen after 3 months, 6 months, 1 year and 2 years postoperatively. Pre- and post-operatively, questionnaires will be completed by the patients. The patient questionnaires EuroQol 5D (EQ-5D-3L and EQ-5D-5L) , Scoliosis Research Society 22 score (SRS-22), Oswestry disability Index, Core Outcome Measures Index score (COMI) and Work status will be completed by the patients during the baseline visit and on each follow-up moment at 3 months, 6 months, 1 year and 2 years.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Including all surgical interventions for patients with adult spinal deformity.
Time frame: 2 years
Generic outcome, measured via the EuroQol 5D (EQ-5D), divided by costs
Time frame: 2 years
Disease-specific value, measured via the Scoliosis Research Society Outcomes Questionnaire (SRS-22), divided by costs
Time frame: 2 years
Disease-specific value, measured via the Oswestry Low Back Pain Disability Questionnaire (ODI), divided by costs
Time frame: 2 years
Disease-specific value, measured via the Core Outcome Measures Index (COMI), divided by costs
Time frame: 2 years
Workstatus, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain
Time frame: 2 years
Return to work, following the International Consortium for Health Outcomes Measurement (ICHOM) standard low back pain
Universitaire Ziekenhuizen KU Leuven
Other
Are Patient Characteristics and Treatment Characteristics Related to the Value of the Adult Spinal Deformity (ASD) Care Pathway in University Hospitals Leuven?
Acronym: VIAV
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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