Original article 111

Compliance of parents with regard to Pavlik harnesstreatment in developmental dysplasia of the hipFreih 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, JordanTel: + 962 79 556 58 63; e-mail: freih@ju.edu.jo

IntroductionIt 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

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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 methodsA 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.

ResultsThe 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

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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

Num

ber o

f par

ents

(%)

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

Num

ber o

f par

ents

University graduate College graduateHigh school graduate Below high school

Compliants

Relationship between compliance of parents and education level.

Compliance of parents Hassan 113

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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.

DiscussionThere 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 (PZ 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 ofthe harness

ProblemsIncidence

(%)

Skin-crease dermatitis in groin or popliteal fossa 12.5Problems with wearing clothes during the winter 11.6Slipping of feet from the harness 11.25Difficulty in carrying the child with harness 10.62Friction of shoulder stirrups with the skin, causing dermatitis 9.37Friction of leg stirrups with the skin, causing dermatitis 8.75Difficulty in changing nappy 8.75Difficulty in cleaning and bathing the child 6.25Inappropriate size 6.25Slipping of shoulder stirrups 4.37

114 Journal of Pediatric Orthopaedics B 2009, Vol 18 No 3

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AcknowledgementThe 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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