Comparing Use of Radiographs Versus Patient Empowerment (CURVE) (CURVE)
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|ClinicalTrials.gov Identifier: NCT05379127|
Recruitment Status : Recruiting
First Posted : May 18, 2022
Last Update Posted : November 2, 2022
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Objective: To evaluate the (cost-)effectiveness of a new patient-empowered follow up (FU) protocol in patients with Adolescent idiopathic Scoliosis (AIS) that is based on patient-reported outcome measures (PROMs), self-assessment tools and physical examination, which is compared to standard FU care by: 1) Effect evaluation, 2) Economic evaluation, 3) Implementation (process) evaluation.
Study design: A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial [PRPT]).
Study population: A total of 812 AIS patients (age 10-18 years) treated by the Dutch AIS Consortium, representing the scoliosis treatment centres in the Netherlands, will be included.
Three subgroups of AIS patients are distinguished, which are monitored over two years:
- Pre-treatment group: adolescents with curve 10-25° (n=132 per arm; total n=264)
- Post-brace treatment group (n=122 per arm; total n=244)
- Post-surgery group (n=152 per arm; total n=304)
Intervention: The new patient-empowered FU protocol (PE-FU) is based on PROMs, self-assessment tools and clinical assessment including physical examination. The protocol aims to detect curve progression or postoperative complications based on these patient-based and clinical parameters to substitute the need to obtain routine x-rays. X-rays will only be taken when progression or postoperative complications are suspected in the pre- and post-intervention groups based on predefined criteria. The standard FU protocol consists of routine full-spine radiographs and routine clinical evaluations.
|Condition or disease||Intervention/treatment||Phase|
|Adolescent Idiopathic Scoliosis||Other: Patient-empowered follow up Other: Standard follow-up||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||812 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||
A multicentre pragmatic randomized trial design with two arms, combined with a patient preference cohort for each arm (partially randomized preference trial; PRPT).
The PRPT consists of three separate randomized controlled trials (RCTs) including patients in the pre-treatment phase, post-brace phase or post-operative phase. Alongside the RCTs prospective preference cohorts are included for each treatment arm (patient empowered follow up [PE-FU] or standard follow up [standard FU]). In the preference cohorts all patients are monitored who are not willing (i.e. who have a preference for either the standard FU or PE-FU) to be randomized to either treatment arm, but who are still willing to participate in the study. By including preference cohorts the generalizability of study results is studied while the internal validity is assured.
|Masking:||Single (Outcomes Assessor)|
|Primary Purpose:||Health Services Research|
|Official Title:||"The (Cost-)Effectiveness of a Patient Empowered Protocol Without Routine X-rays for Follow-up of Adolescent Idiopathic Scoliosis Patients; A Pragmatic Randomized Trial"|
|Actual Study Start Date :||July 17, 2022|
|Estimated Primary Completion Date :||December 31, 2025|
|Estimated Study Completion Date :||December 31, 2025|
standard care during follow-up
Other: Standard follow-up
Routine radiographs are taken at each follow up visit during standard care (to detect possible curve progression or rule out postoperative complications).
|Experimental: Patient-empowered follow-up||
Other: Patient-empowered follow up
The patient-empowered follow-up protocol consists of patient-reported outcome measures (PROMs), self-assessment tools and clinical assessment including physical examination. Radiographs will only be taken when progression of the scoliosis (curve progression) or postoperative complications are suspected based on test results and based on the criteria of so called 'sense of alarm'.
Note: Sense of alarm ('niet pluis') is based on any deterioration on the above-mentioned PROMs, self-assessment tool, and clinician-based measurement instruments, which is a signal for the treating physician to consider when a radiograph is appropriate. Sense of alarm is described as any other concern by the orthopaedic surgeon, parent or child which warrants a radiograph. For both the Bunnell Scoliometer (clinical assessment tool) and the Scolioscoop (patient self-assessment tool) a threshold of ≥4° is used.
- The proportion of radiographs that has led to treatment consequences [ Time Frame: 24 months ]the proportion will serve as an indication of the sensitivity of the new PE-FU protocol and standard FU protocol. The number of x-rays that has led to treatment will be divided by the total number of x-rays in each subgroup to calculate the primary outcome.
- The safety of the standard and the new protocol [ Time Frame: for pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months ]The number of false negative radiological findings with treatment consequences not detected by any of the protocols at the end of the study period. This consists of the proportion of patients with delayed detection of progression or post-operative complications (e.g. a pseudo-arthrosis, curve progression, adding on), which requires treatment or increased vigilance.
- The specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol. [ Time Frame: 24 months ]
- The change in readiation exposure [ Time Frame: 24 months ]The exposure in the new follow up will be compared to standard care using reference values
- Participants perspective: Numeric pain rating scale [NPRS 0-10] [ Time Frame: 24 Months ]Numeric rating scale for back pain, score range 0-10, 0 no pain at all and 10 wrost pain imaginable.
- Participants perspective: condition-specific quality of life [SRS-22r] [ Time Frame: 24 months ]Scoliosis Research Society 22 items about function, pain, self image, mental health and statifaction.
- Participants perspective: health-related quality of life [EQ5D-5L] [ Time Frame: 24 months ]Dutch EQ-5D-5L using the Dutch utility score.
- Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ]) [ Time Frame: 24 months ]Dutch version of the scoliosis appearance questionnaire.
- Global perceirved effect [GPE] [ Time Frame: 24 months ]the recovery and statisfaction of the participant during and after treatment.
- educational status [ Time Frame: 24 months ]questions related to absence from school, absence from physical education classes, frequency of missing school exams, necessity to repeat a class, support and alternatives provided by the school, and return to school and sport after surgery.
- Self-assessment tool: Scolioscoop [ Time Frame: or pre-treatment and the post-brace group at 6, 12,18 and 24 months and for the postsurgery group at 3,12 and 24 months ]Change in the trunk asymmetry (degrees).
- Cost-Benefit analysis: Patient outcome analysis using Quality-Adjusted Life Years (QALY). [ Time Frame: 24 months ]Patient outcome analysis is based on EQ5D-5L.
- Cost-Benefit analysis: Cost analysis [ Time Frame: 24 months ]The costs will be assessed from a societal and a healthcare perspective. From the societal perspective, intervention, other healthcare, unpaid productivity, informal care, and absenteeism costs will be included, whereas only costs accruing to the formal Dutch healthcare sector will be included for the healthcare perspective.
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|Ages Eligible for Study:||10 Years to 18 Years (Child, Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Patients with adolescent idiopathic scoliosis (AIS).
- Age: 10-18 years old.
- Patients scheduled for follow up in one of the participating centres.
- Understanding of the Dutch language.
- Signed informed consent.
- Biplanar (Posterior-Anterior [PA] and Lateral) full-spine x-rays within the last 3 months.
Specifically for the pre-treatment group:
- Girls aged ≤14 years (i.e. 10-14 years) and boys <16 years (i.e. 10-15 years). These patients still have generally 2 years of remaining skeletal growth. Patients above this age with a curve below 25 degrees have a limited risk for progression
- Girls: pre-menarche up to 6 months post-menarche (to estimate end of growth)
- A primary coronal curve of 10-25 degree.
Specifically for the post-brace group:
- Patients aged 12-18 years
- Within 3 months after termination of brace treatment
- Minimum of 6 months of brace treatment
Specifically for the post-surgery group:
• Patients aged 12-18 years
- Patients with juvenile or infantile idiopathic scoliosis with the diagnosis of onset under the age of 10.
- Patients who are undergoing brace treatment. These patients are not included because of the need to monitor brace therapy with radiographs.
- Patients who have undergone previous spinal surgery and are undergoing revision surgery.
- Skeletally mature patients.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05379127
|Contact: Miranda L van Hooff, PhD||+31 24 361 3366||Miranda.vanHooff@radboudumc.nl|
|Contact: Jurre Baetsen, MSc||+31 6 55742308||Jurre.Baetsen@radboudumc.nl|
|Principal Investigator:||Miranda L van Hooff, PhD||Radboud University Medical Center|
|Principal Investigator:||Marinus de Kleuver, MD, PhD||Radboud University Medical Center|
|Responsible Party:||Radboud University Medical Center|
|Other Study ID Numbers:||
|First Posted:||May 18, 2022 Key Record Dates|
|Last Update Posted:||November 2, 2022|
|Last Verified:||March 2022|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
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