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| Name | Class |
|---|---|
| ZonMw: The Netherlands Organisation for Health Research and Development | OTHER |
| Trialbureau Zorgevaluatie Nederland | UNKNOWN |
| Nederlandse Orthopaedische Vereniging | UNKNOWN |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard follow-up | Other | standard care during follow-up |
|
| Patient-empowered follow-up | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-empowered follow up | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The proportion of radiographs that has led to treatment consequences | 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. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| The safety of the standard and the new protocol | 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. |
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Inclusion Criteria:
Specifically for the pre-treatment group:
Specifically for the post-brace group:
Specifically for the post-surgery group:
• Patients aged 12-18 years
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miranda L van Hooff, PhD | Contact | +31 24 361 3366 | Miranda.vanHooff@radboudumc.nl | |
| Jurre Baetsen, MSc | Contact | +31 6 55742308 | Jurre.Baetsen@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Miranda L van Hooff, PhD | Radboud University Medical Center | Principal Investigator |
| Marinus de Kleuver, MD, PhD | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Isala | Recruiting | Zwolle | Drenthe | 8025AB | Netherlands |
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| Vereniging Scoliose Patiënten |
| UNKNOWN |
| Dutch Adolescent Idiopathic Scoliosis (AIS) Consortium | UNKNOWN |
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.
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| Standard follow-up | Other | Routine radiographs are taken at each follow up visit during standard care (to detect possible curve progression or rule out postoperative complications). |
|
| 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 specificity, negative predictive value and positive predictive value of the standard and new patient empowered follow up protocol. | 24 months |
| The change in readiation exposure | The exposure in the new follow up will be compared to standard care using reference values | 24 months |
| Participants perspective: Numeric pain rating scale [NPRS 0-10] | Numeric rating scale for back pain, score range 0-10, 0 no pain at all and 10 wrost pain imaginable. | 24 Months |
| Participants perspective: condition-specific quality of life [SRS-22r] | Scoliosis Research Society 22 items about function, pain, self image, mental health and statifaction. | 24 months |
| Participants perspective: health-related quality of life [EQ5D-5L] | Dutch EQ-5D-5L using the Dutch utility score. | 24 months |
| Participants perspective: Scoliosis Appearance questionnaire short version [short SAQ]) | Dutch version of the scoliosis appearance questionnaire. | 24 months |
| Global perceirved effect [GPE] | the recovery and statisfaction of the participant during and after treatment. | 24 months |
| educational status | 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. | 24 months |
| Self-assessment tool: Scolioscoop | Change in the trunk asymmetry (degrees). | 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 |
| Cost-Benefit analysis: Patient outcome analysis using Quality-Adjusted Life Years (QALY). | Patient outcome analysis is based on EQ5D-5L. | 24 months |
| Cost-Benefit analysis: Cost analysis | 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. | 24 months |
| Flevo ziekenhuis | Recruiting | Almere Stad | Flevoland | 1315RA | Netherlands |
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| Rijnstate | Not yet recruiting | Arnhem | Gelderland | 6815 AD | Netherlands |
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| St Jansdal | Not yet recruiting | Harderwijk | Gelderland | 3844 DG | Netherlands |
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| Maastricht UMC+ | Recruiting | Maastricht | Limburg | 6229HX | Netherlands |
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| Viecuri | Recruiting | Venlo | Limburg | 5912 | Netherlands |
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| Sint Maartenskliniek | Recruiting | Boxmeer | North Brabant | 5835 DV | Netherlands |
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| Amphia | Recruiting | Breda | North Brabant | 4818CK | Netherlands |
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| ETZ Elisabeth | Not yet recruiting | Tilburg | North Brabant | 5022GC | Netherlands |
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| Noordwestziekenhuis groep | Not yet recruiting | Alkmaar | North Holland | 1815JD | Netherlands |
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| OLVG | Recruiting | Amsterdam | North Holland | 1091AC | Netherlands |
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| Amsterdam UMC | Recruiting | Amsterdam | North Holland | 1105AZ | Netherlands |
| Spaarne Gasthuis | Recruiting | Haarlem | North Holland | 2035 RC | Netherlands |
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| Dijklander | Not yet recruiting | Hoorn | North Holland | 1624NP | Netherlands |
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| Albert Schweitzer ziekenhuis | Recruiting | Dordrecht | South Holland | 3318 AT | Netherlands |
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| Groene Hart ziekenhuis | Not yet recruiting | Gouda | South Holland | 2803HH | Netherlands |
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| Leiden UMC | Recruiting | Leiden | South Holland | 2333ZA | Netherlands |
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| Erasmus MC | Recruiting | Rotterdam | South Holland | 3015GD | Netherlands |
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| Maasstad ziekenhuis | Recruiting | Rotterdam | South Holland | 3079 DZ | Netherlands |
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| Juliana kinderziekenhuis | Recruiting | The Hague | South Holland | 2545 AA | Netherlands |
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| Meander | Recruiting | Amersfoort | Utrecht | 3813TZ | Netherlands |
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| UMC Groningen | Recruiting | Groningen | 9713 | Netherlands |
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| UMC Utrecht | Recruiting | Utrecht | 3584 CX | Netherlands |
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| ID | Term |
|---|---|
| D012600 | Scoliosis |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D013121 | Spinal Curvatures |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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