Study title
Referral and
prescription practices at a pediatric neurology clinic in a tertiary care
hospital
Name of student: Dr Kondekar Santosh, Mumbai
Name of Guide: Dr Surbhi Rathi, Professor Department of Pediatrics,
Topiwala National Medical College and Nair Hospital Mumbai Central, Mumbai
400008
Study title
Referral and
prescription practices at a pediatric neurology clinic in a tertiary care
hospital
Introduction
Background and rationale
Neurological
disorders are a major cause of morbidity, mortality, disability in pediatric
population. It also affects quality of life of patient and family.
Pediatric
neurology is a vast specialty of spectrum of diseases from developmental
defects,disorders- disabilities and regression to various insults of central
and peripheral nervous system of a developing brain ranging from infections,
toxins, trauma, autoimmune, vascular, and neoplastic and diseases and syndromes
of unknown etiology.
Pediatric
neurological problems have varied and dynamic presentations and manifestations due
to disease process and developmental process both getting affected by
environmental stimulation. This often
warrants a multidisciplinary systems framework to assess an d treat them on
regular and at times emergency basis.
Developmental
neurology is a major division of pediatric neurology where timely intervention
and referral and treatment is very crucial. Failing this early intervention, a
disability may be inevitable more so in children with cerebral palsy, autism,
ADHD, learning disabilities.
In a
tertiary care pediatric neurology clinic, provision of effective manpower,
resources and institutional structured operating protocol is compulsory to make each child
benefit from early intervention and care; emergency services, investigations, multispecialty
referrals, medicines and newer/changing management policies with judicious
decision making processes, revisions and re-planning the management in a given
case.
Studying the
current differential case load, referral pattern to various specialties, and
their need will help us understand the exact requirement for each specialty
resources and time management in the long run. The aim of this study is to
understand whether current support of other disciplines in terms of manpower,
time and resources in managing pediatric neurology cases at our institute is
optimum, inadequate or in excess; in managing current referral load from
pediatric neurology clinic. These supporting systems primarily involve neuroimaging
& EEG services, genetic metabolic tests, therapy services under
occupational therapy, speech therapy, physical therapy and vision, hearing
assessments, neurosurgery and pediatric surgery references and any other
consultations like dietitian, psychiatrist, orthopedic surgeon etc as needed.
Most
patients though appear to have epilepsy as a main disease or comorbidity.
Prevalence of epilepsy is 10% in pediatric population. Other conditions that are often taken care of
in a pediatric neurology clinic are developmental disorders, genetic syndromes,
neuroregression syndromes, autoimmune, vascular, infections, demyelinating
diseases, and neurological complications of other systemic diseases.
Several
drugs are often prescribed to these children. Neuropharmacology being an
unexplored spectrum in pediatric research, there is likely hood of use of many
drugs for which pediatric research data may not be available. Many drugs may be
even over or under used. They may also be used off label and at times may be
unlicensed.
This study
also plans to understand the pattern of drug use and identify off label
medicine use. It is assumed to be common in pediatric neurology clinics as
there is no enough data from pediatric studies. This study may also help
understand if hospital inventory needs to procure any drugs which may be
routinely used and n ot available in hospital pharmacy. Also if any drugs are
available in excess and need not be procured by hospital; aiming at optimizing
the pharmacological resources. As epilepsy is commonest pediatric neurological
morbidity; commonly antiepileptic drugs may be prescribed. But around 10-20 %
pediatric epilepsy cases may need more than 1 drug and at times some cases may
be refractory to four drugs facing a challenge in diagnosis and management for
which new drugs , nutrients or diet therapies and potential agents or
treatments in other discipline may be tried. This study attempts to reveal any
such therapies being received by the patients presenting at pediatric neurology
clinic.
Apart from
epilepsy headache/migraine can also be an important morbidity which may be
under and over investigated or treated. It does amount to school absenteeism.
As limited
studies are carried out in pediatric neurological disorders, it is important to
know the drugs being prescribed to understand drug utilization.
Drug
utilization research is defined by WHO. It states “it is the marketing,
distribution,prescription, and sue of drugs in society, with special emphasis
on resulting medical, social , economic consequences. The ultimate goal is to
assess the rationality.”
There are
countable studies done in drug utilization in epilepsies. But the research in
referral utilization study is not yet published in literature.
This study
is planned with the objective of evaluating resource utilization pattern in
pediatric neurology clinic with respect to multi specialty referral pattern and
frequency and to identify patterns of drug.
Aim of the study:
To study
patterns of multispecialty referrals and drug utilization in patients attending
pediatric neurology outpatients department in 0-12 year age
Objectives:
1.
To
know the pattern [percentage and frequency] of referral of pediatric neurology
patients referred for various reasons to OT, PT, ST, Opthal, EEG, radiology,TDM,
surgical and other departments
2.
To
descriptively analyze various reasons for referral for different disease groups
and delay in first visit / appointments
3.
To
study patterns of drug utilization [ prescription practices] for different
diagnoses
4.
To
descriptively analyze prescriptions having off label or unlicensed drugs
5.
To
study potential for drug drug interactions
Methodology:
Study will
be commenced after approval from institutional ethics Committee.
Ethical
Considerations: Pediatric age group: Informed consent form will be read out to
guardian/LAR. Signature of guardian or parent on consent form will be taken and
if child is more than 7 years age, an assent form will be added for child’s
consent. There will be no risks, no investigations or procedures.
Confidentiality will be maintained.
Study design: Prospective
Cross Sectional Study
Study setting: Pediatric Neurology Clinic
at BYL Nair Ch Hospital on Monday 1-3 pm
Study population: All
the children 0-12 year attending pediatric neurology clinic will be enrolled,
only after appropriate written informed consent/ assent form from
guardian-LAR/child as applicable.
Source population:Patients presenting to pediatric
neurology OPD
Selection criteria: Following criteria should match
for enrollment and guardian-LAR/child as applicable should be willing for
written consent for the clinical research.
Inclusion criteria: 1.
Age: 0-12 years
2. Child must register for pediatric neurology outpatient
department [OPD]
Exclusion criteria: 1. Patients with neurological
problems presenting to general OPD and emergency department or wards
2.
Patients not having registered for pediatric neurology OPD
Sampling and sample size:
Being a time
bound and institution based project; study data will be collected over 3 months
after approval of ethics committee from Dec 2019 to Feb 2019
As monthly
on an average 15 patients present per OPD day, we expect a max of 180 patients to be enrolled over 12
weeks.
Study duration: As
this is a time bound study for project for university course to be completed in
short span. Study duration will be less than 8 months.
Study tools- Statstics:
Data
collection: Being a time bound and institution based project; study data will
be collected over 3 months after approval of ethics committee from Dec 2019 to
Feb 2019
Variables:
Data management and
analysis:
1.
Differential demography of diseases and co morbidities
2. Referral and
prescription patterns in two different groups 0-6 year and 6-12 years
3. Referral
and prescription pattern in various disease groups, depending on their
prevalence
4. Descriptive
analysis of referrals per patient, multi disciplinary referrals and frequency
of referrals, first appointment delay across various disciplines
5.
Prevalence comorbidities and monotherapy versus polytherapy across disease and
age groups
6. Average
number of drugs/ nutrients per prescription and potential drug drug interaction
pDDI
7.
Prevalence of off label use of drug and nutrients
8. Student T
test will be used for statistical significance of use of montherapy versus
polytherapy, drugs/ versus drugs and nutrients across groups by age and
developmental delay.
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