Compliance of parents with regard to Pavlik harness.pdf

Original article 111
Compliance of parents with regard to Pavlik harness
treatment in developmental dysplasia of the hip
Freih Abu Hassan
A prospective analysis of the views of 160 parents of
children with diagnosis of developmental dysplasia of the
hip and treated by the Pavlik harness over 3.5 years to
assess parents’ compliance. A compliance assessment
was carried out by taking into consideration the various
factors that may contribute to parental concerns during
treatment with a standard orthosis, clinic attendance,
information written daily by parents about problems
encountered, and the final outcome of treatment. Parents
who attended the follow-up appointments in the clinic as
advised, had written information about the harness at
home and claimed that they followed the physician’s
instructions exactly (P = < 0.0002) comprised 94.37%.
Parents who had poor compliance with the harness
comprised 5.62%. A significant relationship (P = 0.000) was
detected between compliance and a willingness to use the
harness again in the future or to recommend it to other
parents. Seventeen (10.6%) parents reported difficulty in
applying the harness in the first week after bathing the
child. At the completion of treatment, 96.25% of the parents
declared that the harness was easy to use and 3.75% said
it was difficult to use. Various problems during use of the
harness, such as skin-crease dermatitis, feet slipping from
the harness, and difficulty in clothing and carrying the child
were reported by 31.9% of the parents, but these problems
did not deter maternal commitment to continuing the
treatment. There was a statistically significant (P = 0.000)
progressive decrease in the difficulty index from the initial
application of the harness to the end of treatment. Active
maternal participation, under direct supervision of an
orthopaedic surgeon, can ensure a satisfactory outcome.
Our study indicates maternal compliance with the
Pavlik harness, which has not been studied before
in detail. J Pediatr Orthop B 18:111–115 c 2009 Wolters
Kluwer Health | Lippincott Williams & Wilkins.
Journal of Pediatric Orthopaedics B 2009, 18:111–115
Keywords: compliance, developmental dysplasia of the hip, parents,
Pavlik harness
Jordan University, Jordan
Correspondence to Freih Abu Hassan, Jordan University, FRCS (Eng.),
FRCS (Tr. & Orth.), Queen Rania Street, Jordan
Tel: + 962 79 556 58 63; e-mail: freih@ju.edu.jo
Introduction
It has been our practice, while treating children with
developmental dysplasia of the hip, to casually observe
the commitments and compliance of parents towards the
use of the Pavlik harness as the standard method of
treatment. This encouraged us to prospectively study
the factors that challenge parents during the course of
treatment. Compliance in healthcare has been defined as
the extent to which a person’s behaviour coincides with
health-related advice, and includes the ability of the
patient to attend clinic appointments as scheduled, take
medication as prescribed, make recommended lifestyle
changes and complete recommended investigations [1].
There is no doubt that the Pavlik harness is the most
popular orthosis, routinely used in almost all health
services dealing with paediatric orthopaedics, and it is
considered to be the gold standard in terms of dynamic
orthosis for the outpatient treatment of children with
developmental dysplasia of the hip below the age of
6 months. It is widely recognized that early treatment of
hip dysplasia using proper splintage allows for high rates
of success [2–4].
The Pavlik harness is considered to be simple, effective,
and practical, and it causes as little disturbance as possible
to the affected child and his surroundings. In addition, the
treatment should be cost-effective and attractive, despite
some difficulties encountered with its usage [5].
Most literature concentrates on physician-related problems,
such as failure of concentric reduction, avascular necrosis,
inferior dislocation and delayed acetabular development
[5–11], but lacks information on parental problems
and attitudes regarding this mode of treatment. The
literature describes only a few cases where the method
of treatment has been abandoned as a result of poor
parental compliance [8,12–14].
Self-reported assessment of compliance is commonly
used because it is a convenient measure of compliance,
memory may limit the accuracy of recall and only episodic
short-term compliance and long-term average compliance
can be ascertained. The most accurate measures of
parental compliance with orthotic devices include the use
of electronic compliance monitors that record whether or
not the orthosis is used properly.
These objective methods require sophisticated protocols
that are very difficult to apply, as the harness has many
stirrups and is made of fabricated cotton. Although
electronic compliance monitors have been used to study
1060-152X c 2009 Wolters Kluwer Health | Lippincott Williams & Wilkins DOI: 10.1097/BPB.0b013e32832942f7
Copyright © Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.

orthotic compliance in various orthopaedic diseases, they
have not achieved widespread use. The purpose of this
prospective study was to determine the true incidence
of parental compliance and factors encountered during
the usage of the harness to improve parents’ satisfaction
and enhance their commitment to using the harness.
Materials and methods
A prospective study analysis of 160 parents who had used
the Pavlik harness as the initial outpatient treatment for
developmental dysplasia of the hip between January 2003
and June 2006 was carried out. The regimen with the
harness was full-time use with weekly changes of the
harness by the parents for bathing and laundering. They
consulted the clinic after 1 week to check the proper
application of the harness and to report any problems.
There was a review after 5 weeks for a plain radiograph of
the pelvis out of the harness to measure the acetabular
index angle. If the acetabular index angle was Z 301 even
after 5 weeks, we recommended continuation of the
regimen, and then a review after 6 weeks for possible
completion of treatment.
All parents had specific instructions from the author
regarding components of the harness, method of application,
and infant hygiene and orthotic care, and were asked to
write down any problems encountered during removal of
the harness for childcare. The parents of six children were
instructed not to remove the harness at all until the fourth
week of treatment or until we considered the hip stable.
None of the parents were informed about the possibility
of assessing the compliance at the end of treatment.
Three different commercial brands of the Pavlik harness
were used: 70 children were treated with the Jordanian
harness, 50 with the British harness and 40 with the
Turkish harness. The children were aged 3–6 months at
the start of treatment (mean 3.12 months). The diagnoses
were 138 cases of acetabular dysplasia with acetabular
index range 30–431 (mean 361), 16 cases of subluxation
and six of dislocation. None of the children suffered from
teratologic hip dislocation, concomitant neuromuscular,
generalized metabolic, arthrogryposis-like or inflammatory
hip disease, nor did they have any associated anomaly that
would adversely affect treatment with the Pavlik harness.
The author at the completion of treatment interviewed
all parents to assess the specific problems encountered
with Pavlik harness usage. The survey studied the various
sociodemographic factors that could affect the treatment,
such as age of the parents, number of children and
education level. Response of the parents towards the
difficulty of the harness at the initial inspection was
gauged, after full instructions by the author on how to use
the harness and at the completion of treatment.
We recorded compliance of the parents to the given
instructions for harness application, difficulty in applying
the harness by the parents in the first week, and help
received from the father with regard to the application
of the harness. Parents were asked specifically if they
would be happy to use the harness again if needed for the
next child, or would advise a friend to use the harness.
Problems encountered during application of the harness,
adequate information given to the parents at the initial
application, the preference or otherwise for an instruc-
tional leaflet with the harness, discomfort caused to the
child by the harness and complications caused by the
harness to the child were also recorded. We used several
methods to assess compliance.
Scheduled diary: mothers kept a diary on a daily basis
during the course of treatment; this gave information on
the problems encountered while dealing with the harness.
Clinic attendance: used to assess ongoing interaction
with the responsible treating clinician.
Interview on orthosis compliance: the mother was asked
specifically about her compliance with the strict instructions
for harness application, and whether she would use it again
in the future if needed or advise a friend to use it.
Physical examination, charts and roentgenograms were
used to gather additional information to determine the
outcome of treatment.
Statistical analysis
Statistical analysis of the data was performed by using a
PC program (SPSS 14 for Windows) (SPSS Inc., Chicago,
Illinois, USA). We used the repeated-measure analysis
of variance and paired-samples t-test to compare the
difficulty index at various stages of harness application.
Chi-squared test with a P value of less than 0.05 being
taken as significant was used to test the effect of their
education level on the compliance of parents with the
physician’s instructions. A Z-test was used to compare
different proportions.
Results
The primary care provider was the mother in all cases, and
she was the individual responsible for the harness. The
mothers’ ages ranged from 20 to 42 years (mean 28.80
years): they each had one to six children (mean 2.39).
Mothers who had finished a university education comprised
38.12%, 19.37% had finished a college education, 33.12%
had finished a high school education and 9.51% had an
education below high school level. A successful result
was considered to be a clinically reduced hip with normal
roentgengraphic parameter of the acetabular index angle
on plain radiographs of less than 301.
Noncompliance was defined as failure to refrain from
one or more of the following: failing to attend follow-up
appointments, removal of the harness for any period of
112 Journal of Pediatric Orthopaedics B 2009, Vol 18 No 3

time during the treatment apart from the period allowed
for bathing the child and laundering the harness,
altering the harness stirrups deliberately or replacing
the harness with another mode of treatment. The
emotional reaction was divided into three subjective
categories (easy, difficult and complex), and was checked
in all three stages of the treatment period (Fig. 1).
Stage I: after the mother had seen the harness in the clinic
before application. Mothers who thought the harness was
easy to use comprised 33.8%, 45% thought it was difficult
to use and 21.3% considered it complex to use.
Stage II: after application of the harness to the child by
the author and explanation to the parents of the
components and the correct application of the harness.
89.4% thought the harness was easy to use, 8.8% difficult
to use and 1.9% complex to use.
Stage III: at the completion of treatment. 96.25%
thought the harness was easy to use and 3.75% difficult
to use. Repeated measures were used to compare the
emotional reaction towards the difficulty index of the
harness at the three stages, and the results showed a pro-
gressive decrease in the difficulty index from stage I to
stage III; this was statistically significant (P = 0.000).
Paired-sample t-test was used to compare the emotional
reaction towards the difficulty index of the harness. We
compared stage I with stage II: the mean of the difficulty
in stage I was 1.88, whereas that for stage II was 1.13, which
was statistically significant (P = 0.000). We compared stage
I with stage III: the mean of the difficulty in stage I was
1.88, whereas that for stage III was 1.04, which was
statistically significant (P = 0.000). We compared stage II
with stage III: the mean of the difficulty in stage II
was 1.13, whereas that for stage III was 1.04, which
was statistically significant (P = 0.004). There was no
statistical significance between the education level
and the emotional reaction towards the difficulty of the
Pavlik harness (P = > 0.05).
Parents who attended the scheduled appointments in the
clinics as advised, recorded information about the harness
while dealing with the harness at home and claimed
that they followed the physician’s instructions exactly
(P = < 0.0002), because they thought their children
had a serious problem, comprised 94.37%. The average
duration of treatment with the harness in the compliant
group was 6–16 weeks (mean 10.18 weeks).
Parents who did not think the matter was serious and
relaxed the stirrups for short periods during the day
comprised 3.12%. Parents who were forced to remove
the harness for 1–2 weeks, because their children were
admitted to the hospital comprised 2.5%. The average
duration of treatment with the harness in the noncompliant
group was 12–18 weeks (mean 14.88 weeks).
A significant relationship (P < 0.05) was found between
compliance and duration of harness treatment. There was
no statistical significance between parent’s compliance
and education level (P = 0.483) (Fig. 2). Mothers who
did receive help from their partner during application
of the harness in the first 2 weeks of treatment
comprised 41.9%. There was no statistical relationship
between the education level and help received from
partners (P = 0.327).
Parents who claimed that they were happy to use the
harness again if needed in the future, and that they would
recommend this type of treatment to a relative or a friend
comprised 99.4%. A significant relationship (P = 0.000)
Fig. 1
Emotional reaction towards the harness
0
20
40
60
80
100
120
Emotional reaction at various stages
Number
of
parents
(%)
Easy Difficult Complex
Stage I Stage II Stage III
Emotional reaction of parents towards the Pavlik harness.
Fig. 2
Compliance and education level
0
10
20
30
40
50
60
70
Noncompliants
Pattern of compliance and education level
Number
of
parents
University graduate College graduate
High school graduate Below high school
Compliants
Relationship between compliance of parents and education level.
Compliance of parents Hassan 113

was detected between compliance and a willingness to
use the harness again in the future or to recommend it
to other parents.
One hundred and fifty-four (96.25%) parents claimed
that they had received adequate information regarding
the instructions, method of application and care for the
harness at the first visit after application of the harness.
Seventy-five (48.1%) parents would have preferred
a leaflet with written instructions and drawings of the
method of application as a parent’s guide to the harness.
Seventeen (22.66%) of these parents reported difficulty
in applying the harness in the first week after bathing the
child. Fifty-eight (77.33%) parents did receive help from
their partner during application of the harness in the first
2 weeks of treatment. There was no relationship between
the education level and preference for an instructional
leaflet (P = 0.0294).
Fifty-one (31.9%) parents reported various problems
while using the harness (Table 1). Twenty-nine (56.86%)
of these used the Jordanian harness, 21 (41%) the
Turkish harness and (1.9%) the British harness. Poor
quality and construction of the stirrups were the main
problems that caused frequent parental concerns because
of dermatitis, and slipping of feet or shoulder stirrups.
None of the above-mentioned problems affected the
decision of the parents to abandon the orthosis or altered
the outcome.
Concerns at leaving the child for 1 week without proper
bathing were expressed by 61.87%. Significant emotional
difficulties with the child being uncomfortable in the
harness were reported by 88.8%. Excessive crying during
the first 2 weeks of treatment was noted by 11.6%.
Parents who were able to describe the harness and knew
its proper application in the first week comprised 89.4%.
Many parents understood the dynamic principles of the
harness as explained to them. Many parents believed
that the excessive discomfort and crying were because of
restriction in lower limb movements.
Discussion
There are three stages of treatment with the Pavlik
harness in cases of hip dislocation: reduction of the
femoral head, retention of the position and promotion
of the development of the hip until the radiological
normalization of acetabular index angle can be esta-
blished [3,8]. The second stage is a very important factor
in determining the duration of Pavlik harness application,
whereas the third applies purely to dysplastic hips.
Treatment failure in dislocated hips is defined as
displacement of the femoral head (subluxation or
dislocation) and persistent acetabular dysplasia, during
the treatment period or the subsequent months. In
dysplastic hips, persistent acetabular dysplasia early or
late is considered failure. Many factors are implicated in
failure. Physicians, orthosis, parents or idiopathic causes
can be the determining factors in the success or failure
of the treatment [6,8]. Physician-related factors were
eliminated through direct supervision by the author.
Parental noncompliance allegedly led to 25% failure of
treatment with the Pavlik harness [12].
This study concentrated on parent-related factors and
found that the parents’ compliance was excellent, as they
followed the physician instructions through attending
regular follow-up in the clinic and documenting their
various concerns in the scheduled diary.
There was no statistical significance between the age of
the parents and their compliance or the education of
the parents and difficulty of application (P Z 0.05). We
eliminated the parental noncompliance that would cause
failure of treatment. The remaining obvious factors that
did cause concern to the parents and frequent discomfort
to the child are related to poor manufacture and cons-
truction of the harness, as it is made by several companies.
Although the parents reported frequent problems
from poor quality of the harness, this did not affect
the outcome of treatment, as it was overcome by their
determination and commitments to cure their children
of their condition. Mothers’ co-operation is essential
for successful use of the Pavlik harness under direct
supervision of an orthopaedic surgeon. The Pavlik harness
should be chosen from the well-known brand names that
have a sound reputation of manufacturing the harness
from nonirritant materials and constructing the harness
properly to eliminate the problems encountered by the
parents during the use of the harness. A well-written
leaflet containing a few points about developmental
dysplasia of the hip, harness components, instructions
and expected problems may enlighten parents and help
to alleviate initial concerns. Our study indicates maternal
compliance with the Pavlik harness, which has not been
studied before in detail.
Table 1 Problems encountered by the parents during the use of
the harness
Problems
Incidence
(%)
Skin-crease dermatitis in groin or popliteal fossa 12.5
Problems with wearing clothes during the winter 11.6
Slipping of feet from the harness 11.25
Difficulty in carrying the child with harness 10.62
Friction of shoulder stirrups with the skin, causing dermatitis 9.37
Friction of leg stirrups with the skin, causing dermatitis 8.75
Difficulty in changing nappy 8.75
Difficulty in cleaning and bathing the child 6.25
Inappropriate size 6.25
Slipping of shoulder stirrups 4.37
114 Journal of Pediatric Orthopaedics B 2009, Vol 18 No 3

Acknowledgement
The author thanks Mr Abbas Talafha MSc (Statistics)
of the Department of Education’s research programme
at the University of Jordan for his invaluable help and
statistical assistance.
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Compliance of parents Hassan 115

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