Investigators
and Institutions

Tandin
Zangpo1, Ugyen Norbu2

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1.

2.

Corresponding Author

                                                                                                            

Background

As stated by the World report on
Disability 2011, around 2-4% (110-190 million people) is experiencing notable
difficulties in functioning. The world’s population in need of assistive
devices was estimated to be 0.5%(1).  

The availability of research related
to prosthetics in low-income countries was very limited (2), (3). The existing studies mostly were
conducted to evaluate products or components of prosthetics (4), (5),(6).

Only few research have examined satisfaction
level with prostheses fabricated using low-cost technology (6). Satisfaction with lower-limb prosthetics have been investigated in few
studies involving low-income countries (7). Ninety
percent of prostheses were in use by amputees, yet the study found that half of
the prostheses were in need of maintenance and repair(8). Lower-limb
amputees were quite satisfied with their prostheses (mean 3.7 out of 5 in
QUEST), but reported 886 problems(9).

However, comprehensive studies of factors which impact
patient satisfaction with prostheses are not available from low-income countries
(10).

The prevalence of amputees requiring lower-limb prostheses in
Bhutan is not documented. By a rough estimate, more than 100 (as per the annual
report of Prosthetic unit) lower-limb prostheses are fitted in Bhutan annually
at the Prosthetic and Orthotic unit of Gidakom hospital.
To date, there is no proper system of follow up of amputees fitted with
prostheses. We lack the knowledge on the level of usage ad their satisfaction. Since
no such studies were conducted earlier on compliance in usage and on assessment
of satisfaction with prostheses, the current study aims to assess the factors associated with the use or non-use and
satisfaction level among the people fitted with lower-limb prostheses in Bhutan.

 

Research
questions

1.    
What is the level of satisfaction among
the amputees fitted with lower-limb prostheses at the National Prosthetic and
Orthotic Centre, Gidakom Hospital?

2.    
What are the factors associated with
non-use (non-compliance) of the lower-limb prostheses by those people initially
fitted with the prostheses?

 

Aim

To assess the level of satisfaction
among the amputees fitted with lower-limb prostheses and to identify the factors
associated with non-use (non-compliance) of the lower-limb prostheses by those patients
initially fitted with the prostheses in Bhutan.

 

Study objectives

Broad

To determine the level of satisfaction
and assessment of the factors associated with non-use of the lower-limb
prosthesis among the lower-limb amputees and to address the issues related to non-compliance
in Bhutan.

 

Specific

1.     Describe
the use of the lower-limb prostheses (compliance)among the lower-limb amputees and
assess the factors associated with non-compliance of the lower-limb prostheses fitted
at the Prosthetic and Orthotic Unit of Gidakom hospital from 2014 to 2018 in Bhutan;

2.     Describe
the satisfaction level among the amputees fitted with the lower-limb prostheses
and Identify variables associated with
amputees’ satisfaction with prostheses and prosthetic use;

3.     Describe the demographic characteristics and compare
groups of amputees based on types and level of prosthesis fitted.

 

Methods and materials

·       
Study design

A cross-sectional study of amputees fitted with lower-limb
prostheses.

·       
Study setting (include period,
site) –

The basic health
services are available to all people of Bhutan through its national, regional,
district and outreach clinics.

In Bhutan, the prosthetic
service is a very recent rehabilitative modality incorporated in to the field
of rehabilitation medicine under ministry of health, Royal Government of
Bhutan.

Prosthetic service is
only available in Gidakom hospital at present, which serves as the National
Centre of Prosthetics and Orthotics. After lower-limb amputation at JDWNRH,
amputees come to Gidakom hospital for prosthetic services. Amputees are fitted
with prostheses and then discharged.

·       
Study areas/location

Table: The records
maintained at the P and O at Gidakom hospital

Sl.
No.

Dzongkhag

Level

Types

Total

1

Thimphu

 

 

 

2

 Chhukha

 

 

 

3

 Samtse

 

 

 

4

 Sarpang

 

 

 

5

 Samdrupjongkhar

 

 

 

6

 Pemagatshel

 

 

 

7

 Trashigang

 

 

 

8

 Mongar

 

 

 

9

 Lhuentse

 

 

 

10

 Bumthang

 

 

 

11

 Trongsa

 

 

 

12

 Wangdue Phodrang

 

 

 

13

Dagana

 

 

 

14

 Punakha

 

 

 

15

 Paro

 

 

 

 

·       
Study period

This study will be conducted within the time frame of 6-7 months in 2018.

·       
Sampling strategy

o  
Target
population/Reference population

The target population will be all the lower-limb amputees
in Bhutan. 

o  
Study population/Source
Population

All the amputees fitted with lower-limb prostheses at Prosthetic
and Orthotic Centre in Gidakom from 2014 to 2018.

o  
Study
group/sample

The sample of our study will include all lower-limb amputees
those who are alive and traceable through the given address and the contact
number maintained in the register of the Prosthetic and Orthotic Centre in
Gidakom hospital.   

The inclusion criteria were: 15 years of age or older, with a
lower- limb amputation and having fitted with prostheses from 2014 to 2018. 350 amputees
fulfilled the inclusion criteria. But
the amputees, who were fitted with lower-limb prostheses outside of the timeframe
of the research, were not included in the study. Upper-limb amputees were too
excluded from the survey.

o   Sampling unit

 The individual
prosthesis fitted prosthesis and consenting to participate in our study.  

o   Sample size calculation

·       
A sample size of
184 have been generated using OpenEpi (version 3.01) out of 350 sample
population fitted with lower-limb prostheses, and with an estimated 50% regular
use of the prostheses with 80 percent power of study within 95% confidence
interval (CI).

·       
With an estimated
number of lower-limb amputees fitted with prostheses at 350, a sample size of
184 is calculated with 80 percent power of study within 95 percent confidence
interval (CI) 

·       
To make up for
missing data, non-response and dropouts we have increased the sample size by 10
percent (202.4).

 

·       
Data collection

o  
Exposure and
outcome variables

       
i.           
Objective 1: Number of people using the
lower limb prostheses and number not using the lower limb prostheses

      ii.           
Objective 2: Number of people satisfied
with the lower limb prostheses and number not satisfied with the lower limb
prostheses

    iii.           
Objective 3: Dependent variable –
Number of people not using the lower limb prostheses; independent variables
prostheses related factors (dimension, weight, fit, appearance, comfort, pain
free, free of abrasiveness, ease of application, durability of prostheses)

   iv.           
Objective 4: Socio-demographic factors
(age, sex, education level, occupation, location of residence) and compare groups of amputees based on types (endo-skeletal,
exo-skeletal prostheses) and level of prosthesis (trans-femoral, knee
disarticulation, trans-tibial, ankle disarticulation, partial foot prostheses)

 

o  
Data
collection instruments/tools/questionnaires

The data will be
collected using structured questionnaire.

 Quebec User Evaluation of Satisfaction
with Assistive Technology questionnaire (QUEST 2.0).

o  
Data
validation

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·       
Analysis and statistics

·       
Ethical approval

The study aims
to conduct in compliance with the ethical principles regarding human clinical
research. Research protocol will be submitted to Research Ethic Board of Bhutan
for approval and all other administrative clearances will be obtained from
respective agencies included in this study.

 

Participants
will be informed about the studies, and both oral and written informed consent
will be obtained. Every participant will be free to decide if they wanted to take
part in the study. Participants do not have to answer any question or take part
in the survey if they feel the question(s) are too personal or if talking about
them makes participants uncomfortable.

 

The information
collected from participants will be confidential and won’t share to anyone
outside research team. It will be used for research purpose only. Participants’
name, address and other personal information will be removed from the data, and
replace by a number (code) that only research team will have access to
participants’ information.

 

The study
focuses toward the benefit of people amputees using lower-limb prostheses. The
research findings aims to benefit both the amputees and the service provider in
knowing about their expectations from the service providers and the changes
that the services providers need to make for the better services to patients.

It will also
help to inform the general public about the availability of prosthetic services
in Bhutan.

 

The report of
the study will be published in peer-reviewed journal and shared among the
relevant stakeholders but, nothing will be attributed to participants by their
name.

 

There will be a
possible implication on the prioritization of procuring prosthetic components
and may have some bearing on disability planning and policy at national level, which
in turn will help in improving the patient’s quality of life, and the quality of
prosthetic and orthotic service delivery.

 

·       
Budget

Explore potential funding agencies in the country.

·       
References

1.       WHO (World
Health Organization). World report on disability 2011. Am J Phys Med Rehabil
Assoc Acad Physiatr Internet. 2011;91:549. Available from: http://www.ncbi.nlm.nih.gov/pubmed/22726850

2.       Borg J,
Lindström A, Larsson S. Assistive technology in developing countries: national
and international responsibilities to implement the Convention on the Rights of
Persons with Disabilities. Lancet (London, England) Internet. 2009 Nov 28
cited 2018 Jan 28;374(9704):1863–5. Available from:
http://www.ncbi.nlm.nih.gov/pubmed/19944867

3.       Harkins CS,
McGarry A, Buis A. Provision of prosthetic and orthotic services in low-income
countries: A review of the literature. Prosthet Orthot Int. 2013;37(5):353–61.

4.       Andrysek J.
Lower-limb prosthetic technologies in the developing world: A review of
literature from 1994-2010. Prosthet Orthot Int. 2010;34(4):378–98.

5.       Borg J,
Lindström A, Larsson S. Assistive technology in developing countries: A review
from the perspective of the Convention on the Rights of Persons with
Disabilities. Prosthet Orthot Int. 2011;35(1):20–9.

6.       Ikeda AJ,
Grabowski AM, Lindsley A, Sadeghi-Demneh E, Reisinger KD. A scoping literature
review of the provision of orthoses and prostheses in resourcelimited
environments 2000-2010. Part two: Research and outcomes. Prosthet Orthot Int.
2014;38(5):343–62.

7.       Matsen SL. A
closer look at amputees in Vietnam: a field survey of Vietnamese using
prostheses. Prosthet Orthot Int Internet. 1999;23(1996):93–101. Available
from: http://www.ncbi.nlm.nih.gov/pubmed/10493135

8.       Magnusson L,
Ahlström G, Ramstrand N, Fransson EI. Malawian prosthetic and orthotic users’
mobility and satisfaction with their lower limb assistive device. J Rehabil
Med. 2013;45(4):385–91.

9.       Magnusson L,
Ramstrand N, Fransson EI, Ahlström G. Mobility and satisfaction with lower-limb
prostheses and orthoses among users in Siera Leone: A cross-sectional study. J
Rehabil Med. 2014;46(5):438–46.

10.     Borg J.
Assistive technology, human rights and poverty in developing countries:
Perspectives based on a study in Bangladesh. Vol. 2, Asia Pasific Journal on
Human Rights and the Law. 2011. 70 p.