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HOW RELIABLE IS LENGTH-BASED
EMERGENCY WEIGHT ESTIMATION IN INDIAN
CHILDREN? RECONSIDERING THE BROSELOW
TAPE
TRAVELING MEDICAL SCHOLARS PROPOSAL
1 QFTE , SUMMER 2006 100%
NARESH RAMARAJAN, SMS I
SUID: 05401958
650-796-5447
NARESHR@STANFORD.EDU
SWAMINATHA V. MAHADEVAN, MD, FACEP, FAAEM
DEPARTMENT OF SURGERY - EMERGENCY MEDICINE
STANFORD-APOLLO EMERGENCY MEDICINE TRAINING
PROGRAM
TABLE OF CONTENTS
1. RELEVANT EXPERIENCE 2
2. ABSTRACT 3
3. INVESTIGATORS 4
4. ADVISORS 5
5. STUDY SITES 6
6. LEARNING OBJECTIVES 7
7. SPECIFIC AIMS 8
8. BACKGROUND AND SIGNIFICANCE 9
9. EXPERIMENTAL DESIGN 10
10. TIMELINE 11
11. FUTURE DIRECTIONS 12
12. TRAVEL JUSTIFICATION 13
13. MEDICAL RELEVANCE 14
14. BIBLIOGRAPHY 15
15. APPENDICES I-V 16
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 1
RELEVANT EXPERIENCE
Prior Institution: Harvard University, Cambridge, MA
Degree, Concentration: AB, Near Eastern Languages and Civilizations and the Study of Religion
Minor: Biochemistry
Year Conferred: 2004
My areas of interest within medicine are international health, emergency medicine, pediatrics, infectious
disease and public health. I also have interests in teaching, public service and travel. My language skills
include native fluency in Tamil, proficiency in Hindi, Urdu, Arabic, French, Wolof and Bahasa Indonesia.
Experience Where & Duration Avg Contributions and Results
When (months) hrs/wk
Prospective Cross- Centre de 13 40 Designed and executed a study to establish
sectional study to Resources months hrs/wk prevalence of obesity, hypertension and
establish rural-urban pour in diabetes in rural and urban elderly. Trained
disparities in L’Emergence summe and supervised a team of field assistants in
prevalence of Sociale rs; 10 collecting data such as blood pressures,
obesity, Participative hrs/wk blood sugar and medical history for over six
hypertension and (CRESP), during hundred rural 70+ elderly.
depression in Dakar-Yoff, term The results of this study were the basis for a
Senegal Senegal. health intervention for the rural elderly by
Jun 2002 – the Senegalese health ministry and
(Research Advisor: Jul 2003 CRESP. Analyzed and presented data and
Prof. Marian Zeitlin, findings to Senegalese government. Data
Tufts University) was unpublishable as it “belonged” to the
Senegalese Health Ministry.
Rockefeller Catholic 10 50 Developed and managed the first HIV/AIDS
Memorial Fellowship Organization intervention for the conflict-affected
for Relief and province of North Maluku. Supervised
Development training of social workers and capacity
Program Officer, AID(CORDAI building of Indonesian non-profit partners.
HIV/AIDS D) N. Planned and wrote proposals through Goal
Jun 2004 - May Maluku, Oriented Project Planning (GOPP) process
2005 Indonesia for successful ($1 million plus) grants with
European Union for improvement of public
Jun 2004 - health infrastructure and introduction of the
May 2005 first HIV/AIDS Voluntary Testing and
Counseling (VCT) center for the province.
Evaluated the effectiveness of health
infrastructure interventions carried out by
United Nations Office for Project Services
(UNOPS), Indonesia in alliance with
CORDAID. Liaised with Government, local
non-profits and CORDAID Europe to plan
the sustainable growth of the intervention.
Emerging Leaders in Cambridge, 22 10 Co-founded and created/developed the
Global Health MA; Jun months hrs/wk vision behind the Emerging Leader’s in
Network 2004 – (ongoing) Global Health Network to support young
present Harvard Alumni. The association fosters
Harvard Institute for inter-disciplinary cooperation amidst young
Global Health professionals and enables them to find
creative solutions to today’s global health
problems. In addition, it serves as an
undergraduate mentoring program.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 2
HOW RELIABLE IS LENGTH-BASED EMERGENCY WEIGHT
ESTIMATION IN INDIAN CHILDREN? RECONSIDERING
THE BROSELOW TAPE
ABSTRACT
It is essential to rapidly estimate the weight of the child undergoing resuscitation.
Knowledge of weight is critical to calibrate drug dosages, perform intubation, administer
intravenous fluid therapy, defibrillation and other life-preserving interventions. There is
no time to weigh the child in the context of resuscitation. Therefore, many methods to
rapidly estimate weight of children given their height and/or age have developed. The
Broselow tape is one such measure widely used in the United States. However,
international applications of this tape must be validated given the variation in height-
weight ratios among different ethnic groups. This study seeks to test the accuracy and
clinical utility of the Broselow tape in an urban pediatric population presenting to Apollo
Hospital in Chennai, India. Furthermore, it will also yield valuable insights into the
applicability of this simple yet clinically useful tool in the broader South Asian
population.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 3
INVESTIGATORS
NARESH RAMARAJAN , A.B, (M.D EXPECTED 2009)
PRIMARY INVESTIGATOR
I am a first year medical student at Stanford University School of Medicine. My primary
medical interests are in international health, emergency medicine and pediatrics. I have
conducted community based quantitative health research in Senegal in 2002 and 2003
to analyze rural-urban disparities and trends in obesity, hypertension and depression for
the Senegalese Health Ministry. I have also conducted quantitative and qualitative
research to evaluate and describe the effectiveness of health infrastructure
interventions carried out by United Nations Office for Project Services (UNOPS),
Indonesia.
I am currently in the Community Health and Public Service concentration at Stanford
Medical School and have taken their introduction to community based research
methods courses. In addition, I took an introduction to Emergency Medicine class in fall
quarter 2005 and spent close to sixty hours shadowing and working with physicians in
the Stanford Emergency Department, where I came to know my advisors, Dr.
Mahadevan and Dr. Quinn.
I am a native of Chennai India (I lived there from 1987 to 2000), and am bilingual
Tamil/English. I also have extensive contacts in and prior experience shadowing and
working with doctors at the two research sites I have chosen for this study.
RAJESH KRISHNAMOORTHI, MBBS
CO-INVESTIGATOR
Dr. Rajesh Krishnamoorthi is a recent graduate (2005) of the prestigious Madras
Medical College, Chennai, India. He has recently completed his internship (House
Surgeoncy) at the Government General Hospital, Chennai, including rotations through
pediatric wards in the Institute of Child Health, Chennai. Dr. Krishnamoorthi has
conducted clinical research on prevalence, prognosis and cardiovascular outcomes of
patients affected by rheumatic heart disease in southern India. He is currently licensed
to practice medicine in India and is interested in Emergency Medicine/Trauma research
as this is a newly emerging field for the country. Dr. Krishnamoorthi will be my co-
investigator and local partner during the data collection efforts and analysis phase.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 4
ADVISORS
SWAMINATHA V. MAHADEVAN, MD, FACEP, FAAEM
STANFORD FACULTY MENTOR AND ON-SITE SUPERVISOR
ASSISTANT PROFESSOR, MED-CENTER LINE, DEPT OF SURGERY-EMERGENCY MEDICINE
ASSOCIATE CHIEF, STANFORD DIVISION OF EMERGENCY MEDICINE
MEDICAL DIRECTOR, STANFORD UNIVERSITY EMERGENCY DEPARTMENT
DIRECTOR, FELLOWSHIP IN INTERNATIONAL EMERGENCY MEDICINE
DIRECTOR, SURGERY 313A, MEDICAL STUDENT CLERKSHIP IN EMERGENCY MEDICINE
Dr. Mahadevan graduated from the UCLA School of Medicine in 1992. After completing
his residency in Emergency Medicine, he joined the faculty at Stanford. He has served
as Associate Chief and Medical Director of the Stanford Division of Emergency
Medicine since 2000. Dr. Mahadevan has mentored and trained many students in his
capacity as Director of the medical student clerkships as well as Director of International
Emergency Medicine Fellowships. He created the Stanford-Apollo Emergency Medicine
Training program in 2005 to train and create an integrated pre-hospital and hospital-
based emergency medical system for Apollo Hospitals, India. Dr. Mahadevan has a
driving interest in International Emergency Medicine and has conducted training and
research in China, Egypt, India, UAE and other parts of the globe. Dr. Mahadevan
recently co-authored a volume titled "An Introduction to Clinical Emergency Medicine:
Guide for Practitioners in the Emergency Department". His research interests include
Cervical Spine Trauma, Head Trauma, Decision Rules for Radiography, Ophthalmologic
Trauma, International Emergency Medicine and Multimedia-based Educational Tools.
Dr. Mahadevan will be at Apollo this summer and will serve as the Stanford faculty
mentor and on-site supervisor.
JAMES V QUINN, MD, MS
RESEARCH DESIGN AND METHODS ADVISOR
ASSOCIATE PROFESSOR, MED-CENTER LINE, DEPT OF SURGERY – EMERGENCY MEDICINE
RESEARCH DIRECTOR, STANFORD DIVISION OF EMERGENCY MEDICINE
Dr. James Quinn graduated from the University of Western Ontario in London, Canada
in 1989 and completed his residency in Emergency Medicine at the University of Ottawa
in 1992. After his graduation he joined the faculty at the University of Ottawa until 1996
when he moved to the University of Michigan from 1996-1998 and then the University of
California, San Francisco from 1998-2003. He receives grant support from the National
Institutes of Health and completed his Masters of Science in Health Services Research
at Stanford University in 2002. As the new research director in emergency medicine he
has developed a research curriculum to help develop resident and faculty projects. His
personal research interests include tissue adhesives, wound care, syncope, clinical
decision rules and cost effectiveness. In addition to seeing pediatric patients in
combined ED settings he has served as an attending at the Children’s Hospital of
Eastern Ontario, and Pediatric ED at the University of Michigan.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 5
STUDY SITES
APOLLO HOSPITALS, CHENNAI
The study will be carried out at Apollo Hospitals in Chennai, India. Chennai is the capital
of the southern state of Tamil Nadu in India and is a metropolitan city with an estimated
population of 6.9 million in 2005. Apollo Hospitals is a highly respected private hospital
group in India, specializing in cutting-edge medical procedures. It has over 60
departments and manages over 1000 beds in the city. Apollo Hospitals, Chennai is
allied with Stanford through the Stanford-Apollo Emergency Medical Training program.
Physicians from Stanford and Apollo have created an Emergency Medical System
(primary, pre-hospital care) and are training EMTs and ED staff to handle acute medical
emergencies since late 2005. Prof Swaminatha Mahadevan, Associate Chief and
Medical Director of the Stanford Emergency Department is the architect of the program,
and travels to India to teach in the training program several times a year. He will be
working with Apollo Hospitals in Chennai this July.
INSTITUTE OF CHILD HEALTH, CHENNAI
The Institute of Child Health and Hospital for Children (ICH) is a premier, multi specialty
pediatric referral hospital, of the Government of Tamil Nadu. This Institution is the
largest of its kind in Asia and caters to the health needs of children of Tamil Nadu and
neighboring states. The ICH treats an out-patient volume of seven hundred thousand
children per year (more than two thousand per day). The Institute of Child Health and
Hospital for Children (ICH) trains a large number of medical graduates in child health
and allied pediatric specialties and undertakes research activities.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 6
LEARNING OBJECTIVES
Learning the process of conducting community based clinical research from conception
to sharing of results
This objective will be achieved through the process of the project itself. I have already
gained invaluable experience in defining a research question, designing a study,
choosing statistical analysis methods, proposal writing, applying for IRB approval and
seeking funding, all with the excellent mentorship of Dr. Mahadevan and Dr. Quinn. I
look forward to gaining practical experience in data collection, analysis and manuscript
preparation for submission to a peer-reviewed journal.
Understand the constraints for clinical research in resource-poor settings and how these
challenges can be overcome.
Clinical research in developing countries is confounded by logistical and technical
difficulties. Dearth of locally trained investigators, extremely high patient volumes
allowing for little time to investigate a new technique and a medical culture not yet
exposed to evidence-based medicine philosophies stifle investigation and diffusion of
innovative methods by local investigators.
Apollo Hospitals and the ICH have been very resourceful in surmounting many of these
obstacles. The management at Apollo is fully supportive of studies conducted by
Stanford affiliates as part of the Stanford-Apollo alliance. Their support will be invaluable
in ensuring the training and application of the tape in a busy ER if our study results
support it. The ICH has similarly instituted a research requirement as part of its resident
training program and has begun to rearrange resident schedules to accommodate
research interests. Electronic patient databases and follow-up guidelines are beginning
to be generated at both sites. I will be able to gain a better appreciation for the
constraints of clinical research in resource-poor settings and how they can be overcome
by working with their staff through this study.
Learn about the standard of clinical care for emergency departments in resource-poor
settings.
I seek to learn what diagnostic and treatment options are available and what factors
determine which options are pursued for major clinical syndromes pertinent to
emergency medicine (chest pain, abdominal pain, fever, trauma etc) in India. I will
shadow and ask doctors a short list of questions pertaining to diagnostic, treatment and
decision making guidelines as I work with in the Casualty and Trauma areas in Apollo
Hospitals and ICH.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 7
HOW RELIABLE IS LENGTH-BASED EMERGENCY WEIGHT
ESTIMATION IN INDIAN CHILDREN? RECONSIDERING
THE BROSELOW TAPE
SPECIFIC AIMS
There are no standardized methods in use for rapid weight estimation in children
admitted for acute pediatric emergencies in trauma centers in Chennai, India.
Physicians currently make an educated guess from experience and/or ask parents for
the last known weight. The Broselow tape has been conclusively shown to improve
accuracy in weight prediction and eliminate the need for memorization and calculation in
such situations1. This project seeks to investigate the accuracy and clinical utility of the
Broselow tape in a pediatric population in urban South India. The Indian growth charts
(see appendices) compared to those published by CDC indicate increasing divergence
of weight/height with age between the two populations.
Hypothesis: The Broselow tape will be accurate for children under 10kg and will show
decreasing accuracy and clinical utility in the 10-18kg and above 18kg categories.
Specific Aim I: To determine the degree to which Broselow weight predicts measured
weight in children under 143cm (tape limit) in three weight categories, under 10 kg, 10-
18kg and above 18kg. Broselow weight will be calculated by measuring subjects with
the Broselow tape according to a standardized protocol.
Specific Aim II: To determine clinical utility of the Broselow tape for use by Apollo
Hospitals in all three weight categories. We will estimate a correction factor that
represents the study population more accurately for affected weight groups if estimated
weight error is not within reasonable clinical limits.
1
Lubitz DS et al. A rapid method for estimating weight and resuscitation drug dosages from length in the
pediatric age group. Ann Emerg Med. 1988 Jun;17(6):576-81.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 8
BACKGROUND AND SIGNIFICANCE
A large percentage of adverse medical events are drug related and dosing errors
contribute most heavily to adverse drug events1. Pediatric medication dosing is
particularly fraught with error due to factors unique to the pediatric patient2 Manual dose
calculation using dosing equations, a practice nearly ubiquitous in pediatric treatment,
has been pinpointed as a high-error activity.3 One well-publicized study reported that
the pediatric service is the most error ridden of all hospital services and flawed dose
calculations to be the most common type of pediatric prescribing error.4
Several factors compound the risk of error when pediatric care must be delivered
emergently. The most significant of these is the need to estimate patient data for input
into medication dosing formulas. Patient weight is the most common of these variables,
and evidence suggests that both physician and nurse estimates are unreliable5,6
Significantly, the same study that found the pediatric service to be the most error ridden
found the emergency department to be a close second.7
A number of methods have been devised to rapidly estimate pediatric weights for use in
emergencies. These include both simple and complex formulae based on age, height
and/or body habitus (slim, average or heavy) (See Table 1).
James Broselow, a North Carolina–based emergency physician, developed a simple
tool to improve weight estimation using established height-weight correlations in the
early 1980s8 The Broselow Pediatric Emergency Tape and accessories provide
physician and emergency services personnel with standardized, precalculated
medication doses, dose delivery volumes, and equipment sizes using color-coded
zones based on similar height-weight correlations.
The improvement in care realized when using the Broselow tape depends on the
accuracy of the precalculated values. The Broselow tape has been shown in several
studies to predict weight in children < 25Kg with the most accuracy compared to other
1 Bates DW, Cullen D, Laird N, et al. Incidence of adverse drug events and potential adverse drug
events: implications for prevention. JAMA. 1995;274:29-34.
2 Kaushal R, Bates DW, Landrigan C. Medication errors and adverse drug events in pediatric inpatients.
JAMA. 2001;285:2114-2120.
3 Lesar TS, Briceland L, Stein DS. Factors related to errors in medication prescribing. JAMA.
1997;277:312-317.
4 Lesar TS, Lomaestro BM, Pohl H. Medication-prescribing errors in a teaching hospital: a 9-year
experience. Arch Intern Med. 1997;157:1569-1576.
5 Harris M, Patterson J, Morse J. Doctors, nurses, and parents are equally poor at estimating pediatric
weights. Pediatr Emerg Care. 1999;15:17-18.
6 Lubitz DS, Seidel JS, Chameides L, Luten RC, Zaritsky AL, Campbell FW. A rapid method for
estimating weight and resuscitation drug dosages from length in the pediatric age group. Ann Emerg
Med. 1988;17:576-581.
7 Lesar, 1997.(op-cited)
8 Broselow J, inventor, Luten R, inventor Vital Signs, Inc, assignee. Broselow Pediatric Emergency Tape.
US patents 4 713 888, December 22, 1987; 4 823 469, April 25, 1989; 5 010 656, April 30, 1991.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 9
methods listed in Table 1. In an Australian study, investigators concluded that the
Broselow tape showed the “least bias and most precision within its limits (46 to 143
cm)”1 A Swiss study found that “the Broselow tape is an accurate means to assess body
weight from length in smaller children; in older children it underestimated body weight.” 2
weight.”2
However, there has only been one investigation of the Broselow tape in a non-
Caucasian population (Pacific Islander/Maori) which showed a clinically significant
underestimation of weight and the need for a correction specific to that population.3
Availability of personnel to operate quality emergency medical systems, much less
pediatric EM, is virtually non-existent in India today. Stanford University Emergency
Medical International and Apollo Hospitals, India launched a joint training program for
EMS personnel focused on pre-hospital and emergency department care in 2005. The
use of the Broselow tape and its corresponding cart of weight appropriate medical
supplies in pediatric resuscitations is a significant part of the training and interventional
process. This step cannot happen without a validation of the tape, given the dearth of
research on non-Caucasian ethnic groups and the results from the Pacific
Islander/Maori study. This study can also yield valuable insights into the applicability of
this simple yet clinically useful method in the broader South Asian population.
Table 1
Methods of Rapid Weight Estimation in Children under 14 yrs of age for Acute Emergencies
Name Eligibility Method
Broselow tape Length: 46-143 Measure with tape and read weight
cm
Advanced Pediatric 1-10 yrs of age Weight in Kg = 2 * (Age +4)
Life Support (UK)
Devised weight Length: 50- Measure length, assign Body habitus and estimate
estimation method 175cm weight from table
Oakley Age 0-14 yrs Read weight from graph corresponding to age
Shann Formula Age: 1- 9yrs Weight in Kg = (Age * 2) + 9
Age : > 9 yrs Weight in Kg = (Age * 3)
Lefiller Formula Age = 1-10 yrs Weight in Kg = (Age * 2) + 10
Age = < 1 mth Weight in Kg = (Age in months / 2) + 4
1
Black K, Barnett P, Wolfe R, Young S. Are methods used to estimate weight in children accurate?
Emerg Med (Fremantle). 2002 Jun;14(2):160-5.
2
Hofer CK, Ganter M, Tucci M, Klaghofer R, Zollinger A .How reliable is length-based determination of
body weight and tracheal tube size in the paediatric age group? The Broselow tape reconsidered. Br J
Anaesth. 2002 Feb;88(2):283-5.
3
Theron L, Adams A, Jansen K, Robinson E. Emergency weight estimation in Pacific Island and Maori
children who are large-for-age. Emerg Med Australas. 2005 Jun;17(3):238-43.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 10
EXPERIMENTAL DESIGN
Overview
The primary goal of this project is to investigate accuracy of Broselow estimated weights
in the sample. This will be achieved by measuring children in three weight groups with
both tools and comparing agreement and error. Tantamount to this goal is validating
and/or modifying the tape for use by Apollo hospitals in its new emergency medicine
program as well as generating primary results for validity of the tape in South Asian
populations.
Design
This project is a prospective cross-sectional study of children receiving outpatient care
at Apollo Hospitals and the Institute of Child Health, Chennai.
Study Population
Children age 10 years and under presenting to the outpatient care wards at the
research sites between June 15th, 2006 and July 31st, 2006 will be eligible for this
study. Those triaged for resuscitation, children referred directly to subspecialty care,
children with severe dehydration or joint contractures will be excluded from the study.
The tape only measures children between 46 and 143 cm, excluding some of the older
children in the under ten age group. The adolescent growth spurt will be largely avoided
by these criteria, avoiding confounding.
The sites chosen receive a range of pediatric patients from all socio-economic
backgrounds and receive a high patient volume each day. Subjects are representative
of the patients seen in the Emergency Departments at these hospitals in resuscitation
situations except for severely dehydrated patients.
Sample and Data Collection
All children will be consented, registered, weighed and measured with the Broselow
tape by the two investigators, Naresh Ramarajan and Dr. Rajesh Krishnamoorthi. The
undressed child will be weighed on a child scale or a baby scale. The scales will be
calibrated daily. The estimated weight of the child will be measured lying down on a bed
from crown to heel using the Broselow tape. Height is not reported by the Broselow tape
and is not a variable in this study. Blinded samples will be measured by both
investigators to determine inter-rater reliability.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 11
Power and Sample Size Calculation
The parameter of interest is the relative difference between the Broselow estimated
weight and the actual weight, defined as (Weight- Tape)/Weight1. We are estimating
the standard deviation of that difference to be 14 percentage points (see Table 2
below).
Table 2: Estimates of SD
Source Population SD N
Black02 <10kg 12.07 121
Black02 10-25 kg 9.67 132
Black02 25-40 kg 12.77 86
Theron05 Asian 13.97 79
A commonly used statistical method to show agreement between two clinical
methodologies is the Bland-Altman analysis2. A lack of agreement is summarized by
calculating the bias, and the limits of agreement, which are the bias plus/minus two
standard deviations of the differences. We will construct a 95% confidence interval for
the difference and will consider the tape equivalent to the actual weight if the confidence
interval will not include + 5%. The null hypothesis states that the tape is equivalent to
the actual weight within a margin of 5%.
Table 3 summarizes the power and sample size calculations to estimate a difference
between the margin of equivalence and the true relative mean difference. To detect a
2% error on 95% limits of agreement we would need a minimum sample size of 387
children divided equally among the three weight groups. We have increased the number
to 390 for ease of analysis in three categories of 130 children each.
Table 3: Sample size required for 80% power (N 80%) and 90% (N 90%) for Diff = Margin-true
relative mean difference
Diff N 80% N 90%
5% 64 85
4% 99 131
3% 173 231
2% 387 517
1% 1541 2062
1
I use this version rather than the more standard (Tape-Weight)/Weight so as to get positive numbers.
2
Bland MJ, Altman DG. Statistical methods for assessing agreement between two methods of clinical
measurement. Lancet 1986, February 8, 307–10.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 12
Statistical Analysis
The accuracy of the estimated Broselow weight will be analyzed on two points, its
measurement bias and precision. The bias measures whether the tape on average
calculates the correct weight. Bias will be estimated by calculating the mean percentage
error (PE) of that method by the formula: PE = 100 × (True weight − Broselow weight) /
true weight. The precision indicates how much variability there is in Broselow weights
when applied to many different children of identical weight. This is estimated using the
standard deviation (SD) of the PE.
Mean and SD of PEs will be calculated in the weight groups: < 10 kg, 10–18 kg, > 18
kg. These weight groups were selected to allow analysis of infants in one group, and
older children whose weight is often more difficult to estimate in another.
Non linear regression may be used to produce a formula for estimating weights from
length and/or age for this sample of children if a correction factor is needed.
Analysis will be conducted using SPSS Base 14.0 for Windows, a widely used statistical
software that Naresh Ramarajan is trained in using.
Possible Outcomes / Interpretations of Results
We could expect to see a difference in any, all or none of the three weight groups. If
there is no significant difference in any of the three groups between Broselow weight
and true weight, the Broselow tape is accurate for the study population and can be
piloted for use in pediatric resuscitations in Apollo Hospitals. If there is a significant
difference in one/two of the subgroups but not in others, we could recommend use of
the tape for those subgroups but not in others pending further research. We will analyze
our date for preliminary correction factors that would need to be validated in a further
study. The Broselow tape would be inaccurate for use in the study population if there
are significant differences across all three categories.
Anticipated Problems
Sample recruitment: We will need 390 children to have sufficient power for the aims of
this study. There is a small chance that the patient volume in the outpatient ward at
Apollo Hospital Chennai may not be sufficient. I have arranged for a backup study site
at the Institute of Child Health, a large government run hospital. Dr. Vijaykumar, Director
of Neonatology at ICH is fully in support of the project.
Children above 143cms will not be included in our study as they are beyond the limits of
the Broselow tape. Other methods of weight estimation such as the Devised Weight
Estimation Method are much less accurate than the Broselow tape, but the information
may still be clinically useful along with physician estimates and last known weight.
These methods will be made available to Apollo Hospitals during the training and
implementation phase after the study.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 13
TIMELINE
3/1/06– 6/15/06 6/15/06 – 7/31/06 8/1/06-8/31/06 9/1/06-12/1/06
Study design, Data collection; Data entry, Dissemination of results
proposal writing, 50 hrs/ wk. 390 clean-up and to Apollo Hospitals;
IRB approval, med subjects in analysis by Manuscript preparation
scholars application Apollo Hospitals subgroup; 40 for submission to peer-
and study setup; 10 and ICH, hrs/ wk reviewed journals; 10
hrs/wk Chennai hrs/wk
FUTURE DIRECTIONS
This project represents the first of several projects designed to adapt the Broselow tape
and other clinical tools routinely used in emergency medicine for international
populations, specifically India. A rural arm of the same project might be conducted by
Indian researchers at a later date based on the results from this study. The results will
also further our understanding of the value of these tools in the United States, where
increasing numbers of minorities are being seen by emergency departments
nationwide. This is particularly relevant to Stanford Hospital and the bay area which has
highest concentration of people of South Asian origin in the country. Follow up projects
in the Stanford Emergency Department are being planned to study whether results
found in Indian children in India are reflective of those found in second-generation
children of Indian origin living in the United States.
TRAVEL JUSTIFICATION
Risk group: India is one of the few rapidly developing countries that has no basic
primary pre-hospital emergency medical care system worth describing. Hospitals
around the country are beginning to setup emergency medical systems as well as
dedicated emergency departments as investment in healthcare in increasing. There is
an acute need for safe, tested and high-utility clinical tools like the Broselow tape to be
adapted for the Indian context. This question can only be answered with an Indian
population in India.
Stanford-Apollo Emergency Medical Training Program: As a comprehensive
training/EMS setup program, the Stanford-Apollo Emergency Medical Training program
holds a distinct position in its ability to transfer new medical technologies and
philosophies to patients on the ground in India. Moreover, the Stanford/Apollo alliance is
the only Emergency Medicine academic partnership that exists in India. Working with
Stanford/Apollo is a unique opportunity to conduct clinical research to answer this
rapidly growing need, especially given the logistical complications in accessing
populations in India.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 14
Professional and personal interest: As a native of Chennai, India, I am excited to
return and conduct clinical research to help the hospitals and people of my hometown. I
share my language and culture with my Indian community partners, the patients and
their providers. This cultural and linguistic concordance along with my ongoing training
in research methods makes me uniquely qualified to lead this study in India.
MEDICAL RELEVANCE
Pediatric medication dosing is particularly fraught with error because of complexities
involving rapid weight estimation and dosing equations. The Broselow tape has been
proven to reduce medication dosing error by rapidly and accurately estimating weight
and avoiding the need to perform calculations.
This study is the first to our knowledge to evaluate the effectiveness of the simple
Broselow tape in Indian children. Results may demonstrate significant accuracy and
clinical utility of the tape to recommend a larger pilot test of the system in pediatric
emergencies in India at Apollo Hospitals, Chennai. Widespread implementation of such
a system in India has the potential to rapidly decrease medical error and save the lives
of many children undergoing resuscitation interventions in India.
BIBLIOGRAPHY
Agarwal DK, Agarwal KN, Upadhyay SK et al. Physical and Sexual growth of affluent
Indian children from 5 to 18 years of age. Indian Pediatrics 1992,29:1203-1284.
Agarwal S, Swanson S, Murphy A, Yaeger K, Sharek P, Halamek LP. Comparing the
utility of a standard pediatric resuscitation cart with a pediatric resuscitation cart based
on the Broselow tape: a randomized, controlled, crossover trial involving simulated
resuscitation scenarios. Pediatrics. 2005 Sep;116(3): e326-33. Epub 2005 Aug 1.
BatesDW, Cullen D, Laird N, et al. Incidence of adverse drug events and potential
adverse drug events: implications for prevention. JAMA. 1995;274:29-34.
Black K, Barnett P, Wolfe R, Young S. Are methods used to estimate weight in
children accurate? Emerg Med (Fremantle). 2002 Jun;14(2):160-5.
BlandMJ, Altman DG. Statistical methods for assessing agreement between two
methods of clinical measurement. Lancet 1986, February 8, 307–10.
Broselow J, inventor, Luten R, inventor Vital Signs, Inc, assignee. Broselow Pediatric
Emergency Tape. US patents 4 713 888, December 22, 1987; 4 823 469, April 25,
1989; 5 010 656, April 30, 1991.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 15
Govtof India, Child Survival and Safe Motherhood Programme Review, Jan 1995,
No.25
Govt. of India, Modified WHO Growth Chart For Indian Children, 1994
HarrisM, Patterson J, Morse J. Doctors, nurses, and parents are equally poor at
estimating pediatric weights. Pediatr Emerg Care. 1999;15:17-18.
HoferCK, Ganter M, Tucci M, Klaghofer R, Zollinger A .How reliable is length-based
determination of body weight and tracheal tube size in the paediatric age group? The
Broselow tape reconsidered. Br J Anaesth. 2002 Feb;88(2):283-5.
Adopting Indian Children (IAIC –Child)’s adoption data report on South Indian
Indians
boys. Available online at http://www.geocities.com/iaicchild/SouthIndianBoysGrowthChart.html
Indians Adopting Indian Children (IAIC –Child)’s adoption data report on South Indian
girls. Available online at http://www.geocities.com/iaicchild/SouthIndianBoysGrowthChart.html
Kaushal R, Bates DW, Landrigan C. Medication errors and adverse drug events in
pediatric inpatients. JAMA. 2001;285:2114-2120.
Lesar
TS, Briceland L, Stein DS. Factors related to errors in medication prescribing.
JAMA. 1997;277:312-317.
LesarTS, Lomaestro BM, Pohl H. Medication-prescribing errors in a teaching hospital:
a 9-year experience. Arch Intern Med. 1997;157:1569-1576.
LubitzDS et al. A rapid method for estimating weight and resuscitation drug dosages
from length in the pediatric age group. Ann Emerg Med. 1988 Jun;17(6):576-81.
NATIONAL FAMILY HEALTH SURVEY NFHS2 1998-99, international institute for
population sciences,mumbai,india,
TheronL, Adams A, Jansen K, Robinson E. Emergency weight estimation in Pacific
Island and Maori children who are large-for-age. Emerg Med Australas. 2005
Jun;17(3):238-43.
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 16
APPENDIX I
WEIGHT OF INDIAN CHILDREN (BOYS AND GIRLS AGED 0-18 YEARS)
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HEIGHT OF INDIAN CHILDREN (BOYS AND GIRLS AGED 0-18 YRS)
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APPENDIX II
HEIGHT AND WEIGHT INCREMENTS FOR AGE IN INDIAN CHILDREN
Low Birth Weight < 2.5 kg
Weight increment per week
0-3 months 200g
4-6months 150g
7-9 100g
10-12months 50-75g
Weight increment per year
1-2yrs 2.5kg
3-5yrs 2.0kg
Length increment per year
1st yr 25cm
2nd 12 cm
3rd 9 cm
4th 7 cm
5th 6 cm
Data from Govt of India, Child Survival and Safe Motherhood Programme Review, Jan
1995, No.25
APPENDIX III
AGE DISTRIBUTION IN THE STUDY POPULATION:
Age Male % Female %
0-4 11.2 11.1
5-9 12.8 12.4
10-14 12.1 11.8
15-19 10.4 10.3
Data from NATIONAL FAMILY HEALTH SURVEY NFHS2 1998-99, international
institute for population sciences,mumbai,india,
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APPENDIX IV
INDIAN ACADEMY OF PEDIATRICS RECOMMENDED MODIFIED WHO GROWTH
CHARTS FOR INDIAN CHILDREN UNDER FIVE YEARS OF AGE
Government Of India Recommended Growth Chart : Modified for Indian Children from
WHO Standards
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APPENDIX V
SUBMISSION FOR IRB APPROVAL
Protocol Number: 5654
Protocol Director: Ramarajan
Department: Medicine
Review Type: NEW - EXPEDITED
Protocol Title: Validation of Broselow Tape in Indian Populations
Submission includes: ExpeditedEligibilityChecklistInitial_97018.doc, nonmed-
rq.doc, oral assent script.doc, oral consent script.doc
The protocol listed above has been accepted for review by IRB 6 at the 05/18/2006 meeting.
BE ADVISED THAT THIS IS NOT AN APPROVAL NOTIFICATION. WATCH YOUR EMAIL FOR
FURTHER CORRESPONDENCE FROM THE IRB.
You may contact Deborah S Woodward, the manager of IRB 6, if you have any questions.
email: deborah.woodward@stanford.edu
phone: (650) 723-6892
eProtocol Human Subjects:
http://hs.stanford.edu
Technical Support:
Kathleen Garcia (650) 723-5481
eProtocol HelpDesk (650) 724-8964
Submit a HelpSU ticket. (Set the request category to Administrative Applications and request type to
eProtocol - Human Subjects)
Naresh Ramarajan, SMS I Traveling Medical Scholars Application 22
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