Implementation of fysical function tests in the usual care of patients with axial spondyloarthritis .

Axial spondyloarthritis (axSpA) manifests itself between the 20th and 40th year
of life and is part of a rheumatic inflammation that causes pain, stiffness,
structural and functional impairments of the spine, pelvis and joints. Ax-SpA
includes ankylosing spondylitis (AS) and non-radiographic axial
spondyloarthritis (nr-axSpA) where no visible radiographic sacrolitis and
ossification is.
Consequently of the disease, physical activities like picking something of the
ground and putting on socks become harder to accomplish. The most important
objectives of treatment are to keep or improve the physical function in
patients. For this reason physical function is an important outcome measurement
to assess disease progression and treatment effects.
It is difficult to assess disease progression and treatment effects
objectively. The most important outcome measurements are based on
questionnaires, since (i) blood measurements/ acute phase responses like BSE
and CRP were not increased/specific for SpA despite many complaints and (ii)
the progression of structural damage on radiological images are a slow process
and therefore not very sensitive for changes on short follow up. The minimal
follow up time to estimate the radiological damage is two year.
Both in research as in daily clinical practice, physical function is measured
with the BASFI questionnaire (Bath AS Functional Index). This questionnaire
measures the patients* perception of their ability of physical functioning,
which can lead to an over- or under estimation of the real physical function
ability. The discrepancy between the patients* perception and the real ability
of physical function can be influenced by needs, priorities, cognitive
functioning, culture, language, education, character, depression and pain. In
patients with axSpA a strong relation was found between psychological variables
(helplessness, depression and passive coping style) and the BASFI questionnaire
score. Thereby, both the BASFI and BASDAI scores ( self-reported measurement
for disease activity) often show large and quick variations over time.
Therefore, an objective measurement is needed to assess the physical function
with no or less influence of the patients* experience.
Despite there are good treatment strategies (biologicals), no objective outcome
measurements are available to measure the improvement in physical function.
Physical tests (performance-based tests) where the patient must perform the
activity instead of filling in a questionnaire of the patients* perception if
they can perform the activity fulfills this need.
Recently, 8 performance based test were developed for ax-SpA, based on
activities described in the BASFI questionnaire. In these tests the time of
complete an activity and level of effort a patient experienced were measured.
It seems that the tests were reliable and result in other information than the
BASFI questionnaire. After a three month intervention with biologicals, the
tests show a significant improvement in the physical functioning, even in
patients who did not response according to the response criteria (ASAS20%).
These results show that self-reported questionnaires and performance-based
tests measured different aspects of physical function. The tests gave a
valuable information in addition on the usually BASFI questionnaire and add
something to the term physical function in axSpA.
Because it is expensive, a lot of effort and time consuming to do all the 8
performance-based test a selection of the tests were made. There were 3 tests
selected that seems to be the most sensitive for changes and were the most
user friendly for clinical practice. The tests include 1) picking up pencils,
2) putting on socks, 3) stand up from the ground. The combination of these
tests termed axial spondylarthritis performance-based improvement index (ASPI).
However, the usability and applicability of the test selection must be
confirmed in daily practice and in a brother spectrum of SpA patients. The
physical function tests were developed en tested in AS patients and it lacks
information about the use of these tests in nr-axSpA patients. In nr-axSpA
patients it is even harder to find disabilities in physical functioning,
because beside the many complaints, clinical observational features like
inflammations in blood, MRI and imagines are mostly absent. The use of ASPI
could be the first step to assess also in nr-axSpA the level of change in
physical functioning and can be therefore a valuable addition on the existing
outcome measures.

The objective of this study:

The overarching object of this study is to assess if the three tests for
physical functioning ('together ASPI measurement') are reliable for patients
with (early or suspicion of) axial spondyloarthritis and to assess the
feasibility in daily clinical practice in addition to the BASFI questionnaire.

The aforementioned overarching objective will be assessed through the following
sub objectives:

1. The reliability and measurement error of the ASPI in nr-axSpA patients that
start with a biological.
2. The responsiveness of the ASPI in nr-axSpA patients that start with a
biological.
3. Natural variance of the ASPI in nr-axSpA patients that are stable on
medication (> 6 weeks NSAID of 3 months biologicial).
4. Natural variance of the ASPI in AS patients stable on medication (> 6 weeks
NSAID of > 3 months biological).
5. The usability and applicability (terms of time and satisfaction) of the ASPI
in AS and nr-axSpA patients.
6. The inter-observer reliability of the ASPI.
7. The evaluation of the applicability of the ASPI in daily clinical practice (
by patient and researcher).
8. Evaluation of the understandability of the original ASPI patient
instructions and the more extensive (new) ASPI patient instructions improve the
understandability.
9. ASPI sensitivity to detect changes in fysical function in "early" axSpA
patients.

An observational study will be performed where subjects were measured during
their regular visits in the VUmc at the rheumatology department. The following
design will be used:
Objective 1: Test-retest on time measurements t=0 and t=1 week
Objective 2: Test-retest on t=0 and t=3 months
Objective 3: Test- retest t=0 and t=3 months
Objective 4: Test- restest t=0 and t=3 months
Objective 5: All measurements for the purpose of objectives 1-4, will be beside
the time per separate measurement, in addition the time measuerd that is needed
to complete the set of three tests.
Objective 6: Inter-observer reliability on t=0 and t=3 months. The ASPI will be
performed by both observers with at least ten minutes between the two
performances. The sequence of the observers that perform the ASPI is alternated
(once observer 1 as first and second time observer 2 as first)
Objective 7: Evaluation of the ASPI in daily clinical practice, by the patient
and the ASPI researcher. For this the patient will be asked to fill in a
questionnaire about several aspects of the test performance and take the tests.
Objective 8: The understandability of the original ASPI patient instructions
will be evaluated and assessed if the more extent version of the (new) ASPI
instructions improve the understandability. This will be assessed when the
patient performs the ASPI test for the first time. First the original
instructions will be read aloud and subsequently asked to the patient (yes/no):
*Is it clear what you need to do?* and, if the answer is *no*: *Which
information did you miss?*. Subsequently, the more extent version will be read
aloud and the same questions will be asked to the patient: *Is it clear what
you need to do?*, (if the answer is no): *Which information did you miss?* and
*Do you think these new instructions are better compared to the old ones?*.

Objective 9: patients perform every 6 months the ASPI during their visit to the
poli clinic. For this objective sutdy patients will be included that are
approached for the sp-EYE study. The Sp-EYE study is a non-WMO complicity
prospective observational cohort study (non-WMO number:2017.037). For this
patient- and disease data will be prospectively obtained and the patient will
complete questionnaires every six months. It concerns patients who were
referred by the eye physician between march 2017 and march 2018, because of
suspicion of axial SpA, based on uveitis anterior and chronical back pain. The
expectation is that approximately 170 patients will be included. These patients
will be approached by their physicianafter there first presentation on the
rheumatology policlinic for participation in the Sp-EYE study (informed consent
procedure). At the same time patients will also be informed about the ASPI
study (part B).

The ASPI will be performed after the regular visits to the VU medical center.
From time point 0 (t=0), about every 6 months till latest t=24 months. Because
the Sp-EYE study has a observational design (where the clinic is leading for
the frequency of policlinical visits and follow-up) not every patient included
in the ASPI study will have a follow-up of 24 months.
The study protocol of the Sp-EYE study is add as appendix with submission
(appendix A). This appendix contains all the details considering the study
background, objectives, population, recruitment method and study parameters. If
teh patient consents with participation in the Sp-EYE study, the patient is
eligible for participation in the ASPI study (part B). For this participation,
separate permission will be asked (separate patient information and separate
informed consent). This will only be the case if the ASPI is approved (current
protocol), before this only the Sp-EYE study will be discussed.
The ASPI will taken place during the regular policlinical visits (every 6
months), at the same time the study activities for the Sp-EYE are performed.
To minimize the study load for the patient, no extra policlinical visits were
scheduled for the ASPI. The impost of participation of the ASPI study objective
9, will exist of an extension of the regular visit for the Sp-EYE study of 10
minutes (beside the extenstion of 10-15 minutes for the Sp-EYE study). The
current protocol focus will only be on the study design of part A. All other
relevant information concerning part B can be found in the study protocol of
the Sp-EYE study, non-WMO number 2017.037, appendix A. The ASPI study will not
be discussed in the Sp-EYE protocol, since the ASPI is part of a WMO protocol.
.

Subjects must in addition to the regular visits perform, twice, three
performance-based tests including 1.) picking up six pencils, 2.) putting on
socks (3x), 3.) stand up from the ground (mat) (3x). Thereby, patients
explained with each test how much pain and exhaustion they experienced. At the
end, patients were ask to fill in a questionnaire where is asked to their
opinion of the performance of the tests (change, satisfaction and effort).