The (cost-)effectiveness of a new patient empowered protocol without routine x-rays for follow-up of adolescent idiopathic scoliosis patients; A pragmatic randomized trial

Adolescent idiopathic scoliosis (AIS) is a three-dimensional deformity of the
spine and trunk that occurs during growth, which can result in life lasting
consequences. The prevalence of AIS is 2-3% of initially healthy children and
in the Netherlands each year 4-6,000 adolescents are newly diagnosed. Part of
these children need bracing or surgical treatment to prevent progression of the
curve and a negative effect on adult quality of life. Therefore, AIS patients
are regularly seen in the outpatient clinic for radiological follow-up (FU) to
detect curve progression, so that timely treatment can be initiated. After
brace or surgical treatment, AIS patients are regularly seen at the outpatient
department for radiological FU as well to detect any curve progression and/or
surgical complications.

Current FU treatment protocols that are used as standard of care are based on a
FU-range as recommended in national and international consensus meetings, but
variation in follow-up frequency exists among Dutch scoliosis treatment
centres. Regular performed consecutive full spine radiographs are standard care
during FU for detection of progression or monitoring for complications after
surgery. Routinely performed radiologic FU during the follow up leads to many
x-rays without consequences for individual patient treatment, since spine
curves are often not progressive. A recent study created awareness of exposing
AIS patients to frequent radiographs by demonstrated and increased incidence of
cancer in later life. The lack of evidence to support radiographic FU and
possible harmful effects in children warrants investigation of new protocols in
which x-rays are only acquired when curve progression or surgical complications
are suspected.

The optimal frequency of radiological FU has not been studied and often
radiographs are acquired that has not led to treatment. This means that most
routinely obtained radiographs are without treatment consequences. An improved
follow up protocol, including patient empowerment, is needed to decrease the
number of radiographs without treatment consequences.

To evaluate the (cost-)effectiveness of a new patient-empowered FU protocol in
patients with AIS that is based on patient-reported outcome measures (PROMs),
self-assessment tools and physical examination, which is compared to standard
or usual FU care.

This study is initiated by the Dutch Scoliosis Consortium, representing all
scoliosis treatment centers in the Netherlands, and will result in an
evidence-based guideline for follow-up of all adolescent patients (surgical,
and non-surgical) with AIS.

A multicenter pragmatic randomized trial design with two arms combined with a
patient preference cohort for each arm (partially randomized preference trial
[PRPT]).

The new patient-empowered and patient-based FU protocol 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.

AIS can be progressive during growth and detection by FU with consecutive
radiographs is currently the standard of care. The potential benefit is that
patients receive less ionizing radiation, as less radiographs are taken in the
new patient empowered FU protocol. However, progression and/or post-operative
complications may not be detectable until a later follow-up date, as routine
radiographs will not be taken. Since the patient empowered FU protocol includes
evaluation of PROMs and quantitative (self-)assessment tools during routine
follow-up at the outpatient clinic, the risk of possibly missing potential
serious progression of complications is minimized. Furthermore, routine
radiographs at the end of the study period (at two year follow-up assessment)
will be made to detect false negatives, which are radiological findings with
treatment consequences (delayed bracing or operative treatment) that were not
previously detected.