CONCORDANCE IN PERFORMANCE OF NRT INTERVENTIONS
Title.
Concordance study on the performance of neuroreflexotherapy
interventions (NRT) on patients with non-specific low back
pain and their characteristics.
Background.
Neuroreflexotherapy (NRT) has been shown
to be effective and cost-efficient for the treatment of subacute
and chronic mechanical pathologies of the spine. The different
studies made consistently show that this intervention improves
local and radiated pain, mobility, degree of disability (that
is the degree of limitation in daily activities) and return
to work.
NRT is characterized by the short-term (up to 90) implantation
of surgical material on fibers and nerve receptors dependent
on the clinically implicated dermatomes in pain episodes of
mechanical pathologies of the spine.
According to the biological mechanism that explains its effect,
the number and exact location of the territories which should
be stimulated in each case are different and must be determined
by means of a meticulous physical examination. The precise
location of these territories is an essential aspect to ensure
the intervention's effect. In fact, in clinical trials carried
out to evaluate its efficacy, implantation in an incorrect
place, within 5 cm of the indicated place, was shown to have
no clinical effect and has been used as placebo (see pages
52 and 54).
In the different studies, the interventions have been carried
out by different doctors and despite that, their results have
been consistent. That shows that the proper performance of
this kind of intervention can be taught and communicated.
However, it may be foreseen that the individual skill of different
specialists (that is, their ability to locate with precision
the place in which the surgical material must be implanted
in each case and their skill in implanting it correctly) could
influence the outcomes obtained, as in fact happens in all
interventions. Similarly, it is also likely that there is
a learning curve and that specialists with more practice are
more skillful.
Objectives.
To evaluate the consistence among different
specialists in performing NRT interventions and to collect
data to determine the learning curve in performing NRT (that
is, the training and practice period which in optimal conditions
a doctor needs to be able to perform NRT on the same level
as an experienced specialist).
With this conceptual aim, the objectives of this study were
the following:
-
In the context of performing NRT on patients with mechanical
pathologies of the spine, to evaluate the consistence
among different specialists in:
-
Establishing the indication or not for performing
the intervention in each case.
-
Identifying the places in which, in the case that
intervention is indicated, the surgical material should
be implanted.
-
To compare the primary objectives between different doctors
with the same and with different experience, in order
to explore the necessary training period in order to achieve
sufficient skill in performing the intervention.
Methodology.
It was a concordance study. Each patient
was evaluated successively and independently by several professionals,
who did not know their colleague's findings or views and their
concordance was appraised by an independent reviewer who did
not know the identity of any of the participating doctors.
6 doctors specialized in performing neuroreflexotherapy participated
in the study. Two were experts (teaching experience and 10
or more years of practice), two accredited specialists (with
5 or more years of practice) and the last two were more recently
trained physicians (with less than 5 years practice).
The participants had been referred to the Kovacs Foundation
Back Unit in Palma de Mallorca from Primary Care Centers of
the National Health System for having mechanical pathologies
of the spine that were potentially susceptible to being treated
by neuroreflexotherapy. No additional criteria for inclusion
or exclusion were established since the indication for the
intervention was one of the variables analyzed.
Initially, each patient was seen by a "clinical"
doctor. This doctor did not participate in the study and his/her
initial work consisted of filling out the patient's clinical
history. Afterwards, each patient was seen successively and
independently by 3 doctors, within the group of the 6 participating
in the study.
To determine the indication for NRT, all of the participating
doctors in the study had access to all the available information
on each patient. When they finished their work, each doctor
indicated his or her decision regarding the recommendation
for the intervention. In the case of recommending the intervention,
the doctor indicated on the patient's back, with colored self-adhesive
labels, the places where he or she would have implanted the
surgical elements. Once the labels were placed, the same doctor
took a photo with a digital camera of the subject's back on
which he indicated his own code number and the patient's reference
number. Afterwards, he indicated on a diagram of the outer
ear the areas on the ear on which he would have implanted
the surgical elements and their order.
No doctor knew the result of his or her colleagues' decision
in regard to the recommendation for the procedure and the
location of the territories eventually identified as those
on which the surgical material should be implanted. To ensure
the blindness of each doctor in regard to the location of
the territories identified by his or her colleagues, each
one had a digital camera (which prevented them from observing
the photo of the same patient taken by another colleague)
and they were prevented access to the study's data collection
sheet and the diagram of the areas of the ear filled out by
their colleagues.
When the three doctors participating in the study who had
appraised the patient finished their work, the patient was
once again attended by his or her "clinical physician"
who, when finding it indicated, performed NRT outside of this
study.
The clinical variables of each patient were collected (to
determine the recommendation of NRT) and the study's basic
variables were the indication or not for performing NRT according
to each specialist, and the location and number of territories
in which each doctor would have implanted the surgical material
in each patient.
A researcher separate from the doctors participating in the
study analyzed the sheets of data collected on each patient,
determining the consistence or not of their decisions on performing
the intervention and about the choice of territories they
identified as appropriate to be stimulated.
Finally, all that information was introduced into a database
by administrative personnel and sent to the team of analysts
that was independent from the team that participated in the
study and determined the concordance among the different professionals
in regard to the indication or not for NRT and to its characteristics
(number and location of surgical material that should be implanted)
as well as the variables that influenced that concordance.
Participants, along with the Foundation's
Science Department.
Doctors at the Kovacs Back Units and the
Unit of Clinical Biostatistics at the Hospital Ramón
y Cajal.
Status.
The design phase has been completed and a
source of co-funding is being sought.
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