Contents - Micronutrient Initiative

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PNG National Micronutrient Survey 2005
Papua New Guinea National Micronutrient Survey 2005
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PNG National Micronutrient Survey 2005
Contents
Map of the four regions of PNG ....................................................................................................... 5
Investigators and Collaborators ...................................................................................................... 6
1. Introduction ................................................................................................................................... 7
1.1 Background ............................................................................................................................... 7
1.2 Justification for the survey and the intended and potential uses of the survey data ................... 8
1.3 Objectives ................................................................................................................................. 8
2. Planning and preparation ............................................................................................................. 9
2.1 Study coordination .................................................................................................................... 9
2.2 Components of the Survey ...................................................................................................... 12
2.3 Target populations .................................................................................................................. 12
2.4 Community Mobilization .......................................................................................................... 13
2.5 Survey Teams ......................................................................................................................... 13
2.6 Training ................................................................................................................................... 14
3. Sampling...................................................................................................................................... 14
3.1 Stratification ............................................................................................................................ 14
3.2 Sample size determination ...................................................................................................... 15
3.3 First stage sampling ................................................................................................................ 17
3.4 Second stage of sampling ....................................................................................................... 17
4. Data collection ............................................................................................................................ 17
4.1 Inclusion and Exclusion procedures ........................................................................................ 17
4.2 Enrollment procedures and consent ........................................................................................ 18
4.3 Data collection at the household ............................................................................................. 19
4.4 Validation study ....................................................................................................................... 20
5. Survey Instruments and outcomes............................................................................................ 20
5.1 General Questionnaires .......................................................................................................... 20
5.2 Modified Fortification Rapid Assessment Tool (FRAT) ............................................................ 21
5.3 Anthropometry ........................................................................................................................ 21
5.4 Anemia .................................................................................................................................... 24
5.5 Iron status and Iron deficiency anemia .................................................................................... 24
5.6 Vitamin A status ...................................................................................................................... 25
5.7 Iodine status............................................................................................................................ 25
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PNG National Micronutrient Survey 2005
5.8 Malaria .................................................................................................................................... 26
5.9 Hookworm ............................................................................................................................... 26
6. Specimen Processing ................................................................................................................. 26
6.1 Hemoglobin cuvettes ............................................................................................................... 27
6.2 DBS processing ...................................................................................................................... 27
6.3 Malaria slides .......................................................................................................................... 27
6.4 Stool........................................................................................................................................ 27
6.5 Urine ....................................................................................................................................... 27
6.6 Salt.......................................................................................................................................... 27
7. Lab Procedures ........................................................................................................................... 28
7.1 TfR and CRP ........................................................................................................................... 28
7.2 Retinol..................................................................................................................................... 28
7.3 Malaria .................................................................................................................................... 28
7.4 Hookworm ............................................................................................................................... 28
7.5 Urinary iodine .......................................................................................................................... 28
7.8 Salt.......................................................................................................................................... 28
7. Data entry and analysis plan ...................................................................................................... 29
8. Dissemination of study results .................................................................................................. 29
9. Time frame................................................................................................................................... 30
Appendix 1: List of publications by principal investigators ........................................................ 31
Appendix 2: Sample Size Breakdown ........................................................................................... 36
Appendix 3: Supplemental information for protection of human research participants ........... 37
Appendix 4: Time Frame ................................................................................................................ 39
Appendix 5 ...................................................................................................................................... 42
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PNG National Micronutrient Survey 2005
Acronyms
AGP
1-acid glycoprotein
CRP
C - reactive protein
DBS
Dried Blood Spot
DOH
Department of Health
MDG
Millennium development goals
MTSP
Mid term strategic plans
PNG
Papua New Guinea
PNGNMS
Papua New Guinea Nutrition and Micronutrient Survey
PSU
Primary sampling Unit
TfR
Transferring Receptor
UPNG
University of Papua New Guinea
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PNG National Micronutrient Survey 2005
Map of the four regions of PNG
Momase Region
Islands Region
Highlands Region
Southern
Region
Momase Region
Islands Region
Highlands Region
Southern Region
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PNG National Micronutrient Survey 2005
Investigators and Collaborators
Support to the Department of Health (DOH) for this survey will be provided by several
investigating and collaborating agencies. These include (in alphabetical order):
CRAFT Technologies
Mahidol University, Thailand
SEAMEO TROPMED Regional Center for Community Nutrition (RCCN)
The University of Papua New Guinea (UPNG)
UNICEF Papua New Guinea (UNICEF PNG)
U.S. Centers for Disease Control and Prevention (CDC)
The core members of the survey coordinating committee are as follows:
Florence Addo (UNICEF PNG) - Survey Coordinator
Dr Gilbert Hiawayler (DOH) – Coordinator Data analysis and collection
Dr Victor Temple (UPNG) – Laboratory coordinator
Enoch Posani (DOH) - Chair
Wila Saweri (DOH) – Survey Advisor
The core survey coordinating committee will be supported by the following members of
the International Micronutrient Malnutrition Prevention and Control Program (IMMPaCt)
at the USA Centers of Disease Control and Mahidol University, Thailand.
Katie Tripp
Dr Bradley Woodruff
Tracy Dearth-Wesley
Bridgette Bowden
Dr Rosemary Schleicher
Dr Pattanee Winichagoon
Please see appendix 1 for a list of the relevant publications by the principal investigators
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PNG National Micronutrient Survey 2005
1. Introduction
At the beginning of 2004, the Government of PNG expressed interest in attending a
training course on conducting national micronutrient surveys, with the expectation of
conducting their own national survey in 2004-2005. The course was led by the CDC in
Bangkok Thailand, in March 2004.
A team of 4 people from PNG attended the training. Based on the initial plans outlined
by the team, the International Micronutrient Malnutrition Prevention and Control
(IMMPaCt) program at the CDC provided funding and technical assistance for the
micronutrient survey, under the terms of a cooperative agreement between the CDC and
UNICEF, to work towards the elimination of micronutrient deficiencies. UNICEF PNG
also agreed to contribute funding and personnel to assist with planning, implementation
and programmatic follow up to the survey.
A meeting to plan the survey was convened in July 2004 in Port Moresby, Papua New
Guinea. Participants included officials from the DOH, UPNG, CDC, Mahidol University,
Thailand and UNICEF PNG. Members of the team included Enoch Posani DOH; Gilbert
Hiawalyer, Director of Monitoring and Research Branch, DOH; Wila Saweri, Technical
Advisor Nutrition and Family Health Services, DOH; Victor Temple, Professor, School of
Medicine and Health Sciences; Pattannee Winichagoon, Associate Professor, Institute of
Nutrition, Mahidol University; Katie Tripp, Micronutrient Specialist, IMMPaCt, CDC;
Bradley Woodruff, Medical Epidemiologist, IMMPaCt, CDC; and Dan Sadler, CDC. The
final plan for the Papua New Guinea National Micronutrient Survey (PNGNMS) was
developed through wide consultations with micronutrient stakeholders and experts both
in PNG and at CDC.
1.1 Background
Malnutrition in all its forms affects socio–economic development in PNG. Nutrition plays
a critical role in the survival, growth, health and development of children, who do not
reach their full potential if malnourished in their early years. In addition, a supply of
adequate micronutrients is crucial for optimal health. The development goals as
contained in Medium Term Strategic Plan (MTSP), the Millennium Development Goals
(MDGs), and other plans cannot be achieved if malnutrition remains a public health
issue.
PNG is a country in transition. While a large proportion of the country is still affected by
undernutrition, people increasingly succumb to lifestyle related diseases like diabetes,
heart ailments and smoking related diseases. Since Independence in 1975, large mining
and oil exploration projects have provided a substantial income for landowners and the
government. In addition, cash crops, like oil-palm, coffee and vanilla, have provided an
income for the rural population. Adaptation to modern lifestyle of Papua New Guineans
affects their food habits and food choices. Although this transition is not uniform across
the country, the change is greatest in areas, where people have access to ready cash
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PNG National Micronutrient Survey 2005
As a result, eating habits have changed from the traditionally grown subsistence diet to a
diet containing an increasing proportion of commercial foods. For example, rice is no
longer the staple food of only urban dwellers and is increasingly consumed by farmers
who cultivate rice as a cash crop or purchase it in the market.
1.2 Justification for the survey and the intended and potential uses of the survey data
As no national nutrition survey has been undertaken since 1982-83, the impact of these
dietary changes on nutritional status is not known. Furthermore, as the last survey was
only conducted on children under 5 years of age and no measures of micronutrient
deficiencies were taken, there are no national data on the micronutrient status of the
population of PNG. Nonetheless, data on local and selected populations show that
micronutrient malnutrition may be common in at least some populations in PNG. In order
to effectively reduce malnutrition, including micronutrient deficiencies, there is need to
know the magnitude and the determinants of nutritional problems.
In 1995 PNG amended the Pure Food Standards and all salt must be iodized however,
the coverage of fortified salt has never been determined nationally. Some small surveys
show a wide variation in estimates of coverage in different locations. Moreover, in 2002
supplementation with high doses of vitamin A was introduced for children less than 5
years of age every 6 months, but the program's coverage or effectiveness is unknown.
Thus, a national survey is needed to:
Generate data for evidenced-based advocacy, social marketing and resource
mobilization for micronutrient interventions including food fortification and vitamin and
mineral supplementation;
- Evaluate the coverage of salt iodation and vitamin A supplementation interventions;
and
- Provide baseline data for planning, programming, monitoring and evaluating
micronutrient interventions.
1.3 Objectives
The overall goal of the PNGNMS is to assess the overall micronutrient status of various
population groups and to evaluate current interventions to improve micronutrient status
in PNG; to enable the DOH and its to more effectively manage existing interventions and
to adequately plan, implement and monitor new prevention programs and evaluate their
impact. The specific objectives are to obtain regionally (Southern, Highlands, Momase
and Islands) representative estimates of:
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PNG National Micronutrient Survey 2005

the household coverage of adequately iodized salt

the urinary iodine levels among non-pregnant women of child bearing age (15-49
years of age)

the prevalence of anemia and iron deficiency in children 6-59 months of age and
non-pregnant women of child bearing age

the prevalence of vitamin A deficiency in children 6-59 months of age and nonpregnant women of child bearing age

the prevalence of stunting and wasting in children 6-59 months of age

the prevalence of underweight and overweight in non-pregnant women of child
bearing age and men over 18 years of age.

the prevalence of anemia in men 18 years of age and above

the contribution of malaria and hookworm to anemia.

to obtain nationally representative data on the use and consumption levels of
centrally-processed staple foods, in order to determine their suitability as vehicles
for fortification
2. Planning and preparation
2.1 Study coordination
The PNG survey coordinating committee has overall responsibility for the quality of data
collection and analysis and for timely and appropriate reporting and advocacy. Tasks of
this committee include:
On-going planning and implementation of the PNGNMS
Ensuring adequate financial, human and organizational resources for the PNGNMS)
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PNG National Micronutrient Survey 2005
Ensuring timely data analysis, report writing and dissemination
Organizing a high level meeting to advocate for action based on the results of the
PNGNMS
The coordinating committee will hold the meetings to:
Review and finalize the draft study protocol, to discuss and approve a work plan and
ensure adequate resources are available to implement this plan
Discuss the draft report presenting the results of the PNGNMS, plan the meeting to
disseminate the final results and plan additional activities to implement preventive
interventions or further studies
The Coordinating Committee will also hold regular meetings to discuss the progress of
the PNGNMS and any problems that need to be resolved. Members of the committee
include representatives of the DOH, UPNG and UNICEF PNG.
Table 1. Allocation of Roles and Responsibilities by Institution.
Task
Responsible
Finalizing study protocol
DOH, UNICEF (CDC available to
assist)
Consultant:
Hiring
UNICEF
Supervising
DOH, UNICEF
Procuring supplies
UNICEF, UPNG
Laboratory:
Collecting and handling of specimens
UPNG
Analysis of specimens
UPNG, CRAFT, SEAMEO, CDC
Logistics:
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PNG National Micronutrient Survey 2005
Developing a work plan
Hiring and training interviewers
DOH, UNICEF
Transport
Informing/involving district
Payment of staff
Data management:
Data management plan
Data entry
DOH, NSO, CDC
Data analysis
Obtaining research and ethical clearance
DOH
Finances:
Arrange funding from UNICEF NY and
reporting to donor
Financial management
Accounting and financial reporting
UNICEF PNG
DOH, UNICEF
DOH, UNICEF
Report writing and dissemination of results:
Write the survey report
Print the survey report
Organize dissemination and advocacy events
DOH/UNICEF PNG/ UPNG
(CDC available for assistance)
A survey coordinator will be hired and will be responsible for the day-to-day planning and
implementation of the PNGNMS. The survey coordinator will report to the National
Micronutrient Study Coordinating Committee.
UNICEF PNG will be responsible for hiring the Survey coordinator. Qualifications of the
successful applicant should include:

An MSc or higher degree in a medical, nutrition or bio-chemical field (a PhD
would be an added advantage)

Expertise in and experience with planning and conducting field-based nutrition or
health surveys

Experience with coordinating multi-sectoral teams and working to a detailed
timeline
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PNG National Micronutrient Survey 2005

Experience with obtaining government approval for activities and with ordering
supplies and obtaining customs clearance

Experience with data analysis, especially analyses using SPSS or EPI-info

Experience with data interpretation and report writing

Availability full time for a period of 1 year

Self motivated and able to work independently and as part of a team
Besides technical assistance for the specific activities of the PNGNMS (e.g. sampling,
data analysis, and laboratory analysis), CDC will make a person available who will work
closely with the survey coordinator at critical points in the survey, such as finalizing the
protocol, developing the questionnaires, training the survey workers, supervising field
data collection, data analysis and interpretation, and writing the report).
2.2 Components of the Survey
The PNGNMS will be composed of integrated components that will be used to assess
the nutrition micronutrient status of the target groups. The various methods to be
employed include anthropometric measurements, hematological and biochemical
assessments, salt sample analysis and interview questions. A modified Fortification
Rapid Assessment Tool (FRAT) will also be utilized to gather further information on
potential vehicles for food fortification.
2.3 Target populations
The target populations to assess anemia, iron, and vitamin A status are children 6 to 59
months of age and non-pregnant women of child-bearing age as these groups are the
most vulnerable to deficiencies of iron and vitamin A.
Men are at substantially lower risk of many nutritional deficiencies and are therefore not
specifically targeted in most micronutrient assessments. However, hemoglobin status
will also be assessed in adult men 18 years of age and older in the PNGNMS in order to
ascertain whether anemia is due to iron deficiency and/or other factors. Nonetheless,
men may be included in such surveys because they are much less susceptible than
women and children to iron deficiency, but equally susceptible to other causes of
anemia. Therefore, survey findings indicating that anemia is common among women
and children but rare among men provide evidence that iron deficiency is a predominant
cause of anemia.
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Anthropometric measurements will be taken for all eligible children (6-59 months),
women 15-49 years and men (18 years and over).
2.4 Community Mobilization
Before commencing data collection, officers from the DOH and UNICEF, in coordination
with the provincial government offices, will organize and implement a community
mobilization campaign. These organizations will produce information papers and radio
spots and send this information to all communities selected to take part in the survey so
that people will know well ahead of time when the data collection for the survey will
occur and appreciate its importance.
2.5 Survey Teams
Six field teams will collect the data for the PNGNMS. Each team will consist of one team
leader, one interviewer, one lab technician, and one anthropometrist. One regional level
supervisor will also be recruited to help with organization and transport of supplies and
laboratory specimens. Some survey workers will come from the various organizations
participating in the PNGNMS, such CDC, DOH and UPNG. Please see table 2 for a
description of team roles and responsibilities.
The community mobilization system will be arranged to ensure that the chief of each
selected village will have been informed and will notify selected households when the
survey teams will arrive. Where possible additional advance notice will be sent to each
selected village just before the arrival of the survey team.
Table 2. Roles and responsibilities
Role
Responsibilities
Team Leader
Identify selected households,
Maintain records and cluster control sheets,
Check labels and completed data collection forms
Plan revisits.
Laboratory technician
Perform finger sticks and phlebotomy
Manage laboratory specimens during data collection
Collect urine and stool specimens
Anthropometrist
Measure height and weight of children and women
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Interviewer
Interview respondents
Assist in weighing and measuring women and children
Collect household salt specimen
2.6 Training
All team members will receive 8 days of instruction regarding the overall survey
objectives and procedures. Some components of the training include:
Interviewers responsible for administering the survey questions will participate in roleplaying interviews to insure consistency.
Interviewers will also complete a standardization exercise for anthropometric
measurements so that they can assist the anthropometrists.
Interviewers will also be trained on how to collect, label and store the specimen of
household salt.
Laboratory technicians will be trained by CDC and UPNG lab personnel on procedures
for performing a finger stick, the preparation of the filter paper dried blood spot, the use
of the HemoCue™ photometer for hemoglobin measurement, the preparation of a thick
blood smear for malaria, and the collection and field processing of urine and stool
specimens.
Anthropometrists will be trained to measure weight and height or length on children and
adults. This training will include practice on both adults and children and a
standardization exercise measuring height or length of children.
There will also be two days pilot testing of all survey procedures before data collection
begins to ensure that all survey procedures are well understood.
3. Sampling
3.1 Stratification
A two-stage cluster sampling design will be used with stratification to generate national
estimates for the major nutrition outcomes as well as region-specific estimates for the
four main regions (Southern, Highlands, Momase and Islands). The stratification by
these four regions will be done for the following reasons:
The diversity of the landscape, and agriculture and cultural practices may result in wide
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PNG National Micronutrient Survey 2005
differences in the nutrition outcomes among the regions.
Programs may need to be introduced or targeted regionally and region-specific
estimates could help identify those regions in greatest need of interventions.
The credibility of the survey findings at a regional level will be enhanced.
The 2000 census enumerated a total population of 5.2 million persons with 1,041,820
(20%) residing in the Southern region, 1,973,996 (38%)in the Highlands region,
1,433,432 (28%) in the Momase region and 741,538 (14%) in the Islands region.
However, the PNGNMS will select the same sample size for each region. Because of
the resulting differences in sampling fraction for each region, population data from the
2000 census will be used to weight the calculation of nationwide estimates of the
nutrition outcomes.
3.2 Sample size determination
The sample size for the PNGNMS was determined using standard statistical procedures.
The anticipated prevalence, desired precision, and assumed design effect for each
outcome in each target group were determined based on the results from previous
surveys and studies related to the outcomes of interest. Sample sizes for each outcome
in each target group were calculated using the standard formula:
N = 1.962 x pq x DEFF
d2
Where: N = Minimum sample size needed
1.96 = the z value to obtain a 95% confidence interval
p = the assumed prevalence of the nutrition outcome of interest in a target group
q = 1-p
d = the desired precision expressed as a half-confidence interval
DEFF = the design effect to account for the loss of statistical precision from
cluster sampling
For many nutrition outcomes, conservative assumptions were made to intentionally
overestimate the necessary sample size. For example, because the sample size is
maximum if the prevalence is 50%, if the prevalence of a specific outcome was thought
to possibly approach 50%, the sample size calculation assumed 50% as the prevalence.
Similarly, design effects were overestimated to ensure adequate sample sizes.
For example, the calculation of a sample size for anemia in children 6-59 months of age
was based on an estimated anemia prevalence of 50%, a precision of +/-10 percentage
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PNG National Micronutrient Survey 2005
points, and a design effect of 2. Using the standard formula above, 193 children would
be needed per region. The nationwide sample would require 4 times as many children 659 months of age because there are 4 strata, thus resulting in a total of 768 children.
But, of course, a certain proportion of selected households will be unavailable or refuse
participation (household non-response) and a certain proportion of children in consenting
households will be absent or their mothers will refuse consent for a fingerstick (individual
non-response). Taking into account an estimated individual non-response of 20%, a
household non response of 10%, and the proportion of children 6-59 months of age per
household in PNG (0.7 children per household), the required number of households that
need to be selected to obtain fingerstick blood on 768 children is 1, 524 (768 / 0.80 /
0.90 / 0.7).
For most of the outcomes and target groups of interest, there are very few data on which
to base the assumptions necessary to calculate sample size. As described above, a
prevalence of 50% was selected for such indicators to provide the largest sample size
for the given target population. (See appendix 2 for a detailed description of the
assumptions used to generate the sample sizes for all major outcomes) For a given
target group, sample sizes were calculated separately for each nutrition outcome
measured in that group, and the maximum size was taken for that target group. We
decided that the number of households for the entire survey should be 1600 households,
as this will provide at least the desired precision for most of the nutrition outcomes of
interest. Table 3 shows the number of target individuals who will be included in the
sample of 1600 HHS.
Table 3. Estimated Number of participants by target group in strata sample of 400
households and total sample of 1600 households
Target group
Indicators
Number of
expected samples
from participants
per Strata
Total number of participants
nationally
(4 strata in total)
1600 households
Children 6-59
months
Laboratory
202
806
Anthropometry
227
907
Nonpregnant
women 15 49 years*
Laboratory
197
789
222
888
Adult men 18
years and
above*
Laboratory
203
810
243
972
Anthropometry
Anthropometry
* On ½ of all house holds
** These figures take into account the expected presence of participants at the
household and the household individual response rate.
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At every household visited anemia, iron deficiency, malarial load, wasting and stunting
will be measured in each child in the household. In every second household anemia, iron
deficiency, BMI, urinary iodine, malarial load and hookworm will be measured in all nonpregnant women of child-bearing age, and anemia will be measured in all men above 18
years of age, giving a total of 100 sampling units nationally.
3.3 First stage sampling
The National Statistical Office provided a list of all census units in PNG in an Excel
spreadsheet. For the first stage of sampling, the sampling unit, and therefore the
primary sampling unit for the PNGNMS, was a census unit. For each of the four regions,
25 primary sampling units were selected probability proportional to size.
These randomly selected primary sampling units are located in all 20 provinces and in
75 of the 87 districts in PNG: 16 districts in Southern region, 24 in the Highlands regions,
23 in the Momase region and 12 in the islands region. Although all the provinces will be
included in the survey, it is important to note that the precision around the estimates of
the prevalence of all outcomes will not be sufficient to interpret the results of the survey
by province.
3.4 Second stage of sampling
Before data collection begins the survey coordinator will work with officers from the
National Statistical Office to obtain accurate and complete lists of the households in
each selected primary sampling unit. In large primary sampling units (great than 250
house holds) where it is not possible to make a list of all households, a sub-section of
the primary sampling unit will be chosen at random probability proportional to size. A list
of all the households in this subsection will then be created. In both smaller units with a
complete list of all households and larger units where the list of households includes only
a selected sub-section, simple or systematic sampling will be used to select households.
In order to select a sample of 1600 households in total, 16 households will be selected
from each of the 100 selected primary sampling units. Although the basic sampling unit
is the household, the unit of analysis for all the nutrition variables is the individual child,
woman or man in the household. In each selected household, all eligible persons in the
identified target groups will be offered participation in the survey. For the PNGNMS, a
household is defined as a group of people who share a common cooking pot.
4. Data collection
4.1 Inclusion and Exclusion procedures
Of the 16 randomly selected households visited per sampling unit, households will be
eligible for participation in the nutrition survey providing that the following criteria apply;
1) any one of the defined target groups are represented in the household, i.e. a child 617
PNG National Micronutrient Survey 2005
59 months of age, and/or a woman of child-bearing age 15-49 years of age, and/or a
man 18 years and older, 2) the eligible person lives in the selected household at the time
of data collection, and 3) consent is given by the participant or a responsible adult for
survey participation.
4.2 Enrollment procedures and consent
Upon arrival at the first selected household the survey team supervisor will ask whether
any children 6-59 months live in the household. If there are no eligible children this will
be recorded on the summary form for the HHs in the sampling unit and the team will go
on to the second house. If there are eligible children at the first house, the team
supervisor will then explain the purpose of the survey, and the methods and procedures
to the head of the household and ask for consent to proceed with data collection in this
household.
At the second house, the survey team supervisor will ask whether any children 6-59
months, and/or women 15-49 years old, and/or men over 18 years old live in the
household. If there are no eligible people, this will be recorded on the summary form for
the HHs in the sampling unit and the team will go on to the third house. If there are
eligible subjects in the second house, the team supervisor will then explain the purpose
of the survey, and the methods and procedures to the head of the household and ask for
consent to proceed with data collection in this household.
For the third house (and every other next selected household following) visited, the
procedure will be the same as for the first house. And for the fourth house (and every
other next selected household following), the procedure will be as for the second
household.
All household members who fit the criteria for a target group will be included in the
survey if verbal consent is received. Please see appendix 3 for more information on the
consent process.
At the start of the survey team's visit to selected household, household members or
others in the community will be asked, where feasible, to fetch absent household
members who are eligible for survey inclusion. When any of the selected eligible
occupants of a house are not at home, up to three recall visits if possible may be made
for another time, over subsequent days. Selected houses which are either vacant or in
which all eligible occupants are away, will not be replaced.
Survey teams will record for each selected household in the survey sample the following
information, 1) whether the house was unoccupied or occupied, 2) whether at least one
member of the target group was present (required target groups will differ for every other
house) in the household, 3) how many eligible subjects from each group lived in the
household, 4) whether household consent was given, 5) whether consent was given for
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each of the individuals selected for the survey in each house, 6) whether data collection
was completed for each of these individuals, and, 7) if data were not collected from any
of the selected subjects, why. These data will allow calculation of household weights,
response rates and the determination of reasons for non-response.
4.3 Data collection at the household
On arrival at the household the team leader will ask for the head of the household who is
currently living in that property. All children 6-59 months identified in each of the selected
households will qualify for participation in the survey, whether or not their mother is also
taking part in the survey. The child’s mother or caretaker will be asked to answer the
questionnaires on their behalf. All non-pregnant women 15-49 years in every second
selected household will be included in the survey and every woman in these households
will be asked to participate in the survey. All men aged 18 years and over in every other
selected household will also be asked to participate.
Once eligible household members have been identified, the interviewer for the survey
team will start with the care taker of each eligible child. Then all eligible women and men
will be interviewed. The interviewer will request that a 15 gramms sample of salt be
taken from the house. The interviewer will provide iodized salt to replace the salt
collected.
After the interviews have been completed, children, women and men will be weighed
and their height/length measured by the anthropometrist. These measurements will be
recorded on the data collection forms.
When the measurements are complete the women in the household will be asked to
provide a urine specimen to assess urinary iodine. The laboratory technician will provide
women with a screw top urine cup and specific directions regarding the urine collection
process. If they are unable to provide a sample at that time they will be asked to drink
some water, so that they might be able to provide a sample by the end of the blood
collection.
If there are any eligible men in the household the trained laboratory team member will
collect capillary blood using a HemoCue Lancet. The first two drops will be wiped away
and the third drop will be drawn into a HemoCue cuvette to evaluate hemoglobin. After
all eligible men have been tested each eligible woman will have her finger pricked. The
first four drops of blood will be dropped directly on to filter paper to create four dried
blood spots, which will later be assessed for TfR, CRP and serum retinol. The fifth drop
of blood will be drawn into a Hemocue cuvette for evaluation of hemoglobin by the
HemoCue Hemoglobin System (HemoCue AB, Angelholm, Sweden). A final drop of
blood will be used to create a thick smear for malaria assessment.
After all eligible men and women have had their blood drawn all children included in the
survey will also have capillary blood collected in exactly the same way as described
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PNG National Micronutrient Survey 2005
above.
For all survey participants having their hemoglobin measured the HemoCue cuvette will
immediately be placed in the HemoCue and the measurement will be read off the
instrument and recorded on the data collection form. All people participating in the
survey will be told their hb value. Anyone with a hemoglbin concentration below the
World Health Organization cutoffs (see section 5.4) will receive a referral to the nearest
clinic.
Stool will be collected from all eligible children between the ages of 24-59 months.
Caretakers will be provided with cups with screw tops lids to collect the stool. If possible
stool will be collected during the visit. If that is not possible then caretakers will be left
with the cups and the survey team will re-visit the household once more before leaving
that PSU, in order to collect the specimen.
Once the interviews, anthropometry and biological specimen collection are complete the
team will leave the house and move on to the next household on their list, where they
will complete the same procedure as the one described above. Before leaving the
household the team will ensure that all waste has been put in bio-hazard bags and
lancets disposed of in the sharps collector. The team supervisor will also check the data
collection form to ensure complete and accurate data recording.
4.4 Validation study
In a sub sample of house holds in the 6 primary sampling units surrounding Port
Moresby (NCD) children (24-59 months), women (18-59 years) and men (18 years and
above) enrolled in the survey may be asked to provide a venous blood sample in
addition to the samples described above. The survey staff may also volunteer for this
study. The venous blood collected will be used to validate the DBS TfR, CRP and retinol
collected from the rest of the survey. (See appendix 5 for details of the validation study).
5. Survey Instruments and outcomes
5.1 General Questionnaires
The questionnaire portion of the data collection form will include questions on anemia,
vitamin A and iodized salt. The questionnaire will be translated into Pidgin. In areas
where pidgin is not widely understood the questionnaire will be translated verbally by a
local person who can speak pidgin and the local language. Field workers administering
the questionnaire will be hired from the areas where the survey will be conducted to
provide on site translation of the questionnaire questions. Due to language barriers the
questionnaire will be very brief and only aim to collect fact-based information. For
example, interview questions may inquire about demographic questions (women’s age,
reproductive status and history) and socioeconomic status questions (educational level,
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PNG National Micronutrient Survey 2005
household socio-cultural background). Similarly the child questionnaire will include
additional parameters on sex, age, breastfeeding status and complementary feeding.
5.2 Modified Fortification Rapid Assessment Tool (FRAT)
The Fortification Rapid Assessment Tool (FRAT) method created by PATH Canada will
be adapted for use in the survey. A national sample of each participant group (children,
women and men) will be asked questions from the FRAT, specifically information on
consumption with estimates of quantities of the already identified centrally processed
foods to fortify (sugar and oil with vitamin A, rice, wheat flour and complementary foods
with iron, folic acid and other nutrients).
FRAT information will be gathered on a national sample of women men and children. In
each sampling unit two women and two men and two primary caregivers of children
included in the survey will be asked the FRAT questions. To ensure that FRAT
information is gathered from 6 different households per cluster, women will be
interviewed in the first two eligible houses visited, children’s care takers in the next two
and men in the two houses after that.
5.3 Anthropometry
Height and weight measurements will be taken for all non-pregnant women of child
bearing age and all children 6-59 months of age included in the survey. Children’s ages
will be determined from a health card or other documentation, if available. If no such
documentation is available, a local calendar will be used to determine age to the nearest
month. Anthropometric indicators of length/height-for-age, weight-for-age and weightfor-length/height will be determined for children (see box 1) and weight and height will be
used to determine body mass index (BMI) in women (see box 2).
a) Length/height
For children less than 24 months old, recumbent length will be measured to the nearest
0.1 cm using a height board either manufactured or patterned on height boards made by
Shorr Productions (Olney, Maryland, USA). The same height board will be used to
measure standing height to the nearest 0.l cm for children greater than or equal to 24
months of age and for adult women. All subjects will be measured without shoes or hair
accessories which add artificial height.
b) Body weight
UNICEF Seca Uniscales will be used to measure body weight of women of childbearing
age 15-49 years and children 6-59 months. The weight of the children will be measured
21
PNG National Micronutrient Survey 2005
by taring the scale after the mother's weight is recorded, than handing the child to the
mother
BOX 1. ANTHROPOMETRIC INDICES
Reference: Pediatric anthropometric data presented in this report were interpreted using
the international growth reference (NCHS/CDC/WHO reference). This reference is
based on growth curves for children in the United States and studies have demonstrated
that healthy, well-nourished children from most countries exhibit a pattern of growth that
is similar to that of the reference.
Z-scores: The anthropometric indices used for evaluating the nutritional status of
children include height-for-age, weight-for-age, and weight-for-height. These indices are
interpreted using classifications based on Z-scores (standard deviation units from the
reference median). The World Health Organization (WHO) recommends that a Z-score
cut-off point of <-2 be used to classify low height-for-age, low weight-for-age, and low
weight-for-height for estimating the prevalence of malnutrition. The reference Z-score
distribution for each index has a mean of 0.0 and a standard deviation of 1.0. A Z-score
cut-off of +2 should be used to classify high weight-for-height for estimating the
prevalence of overweight or obesity (also a form of malnutrition). A Z-score of -2
corresponds to the 2.3rd percentile on the reference distribution, while a Z-score of 2
corresponds to the 97.7th percentile on the reference distribution. Thus, with any of the
indicators, a prevalence less than or equal to 2.3% is regarded as the surveyed
population being free from malnutrition based on that indicator.
Height-for-age: A low height-for-age indicates growth stunting, which reflects a long
term deficit of nutritional status and/or a history of illness and disease such as diarrhea
and acute respiratory infection. On a population level, a high prevalence of stunting is
usually associated with poor socioeconomic conditions and a greater risk for frequent
and/or early exposure to adverse environmental conditions such as illness and
inadequate nutrition. A decrease in the prevalence of stunting usually parallels
improvements in economic conditions. In developing countries the prevalence of low
height-for-age ranges from 10% to 60%. Countries with a <20% prevalence in low
height-for-age (Z-score <-2) are classified as countries with low prevalence of stunting
by WHO.
Weight-for-age: This index is a composite of height-for-age and weight-for-height. On a
cross-sectional basis, weight-for-age is less useful than height-for-age or weight-forheight in defining nutritional status. In most populations where there are few children
with low weight-for-height, the weight-for-age status provides essentially the same
information as height-for-age.
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PNG National Micronutrient Survey 2005
Weight-for-height: Low weight-for-height, or wasting, is an indicator of acute undernutrition and is often the result of severe food shortages and/or prolonged severe illness.
Unlike the wide variation in stunting rates observed in developing countries, the
prevalence of wasting is usually less than 5% in most countries provided there is no
severe food shortage. Therefore, a wasting prevalence of more than 5% is of concern; a
prevalence of 10% to 14% is considered serious; a prevalence of 15% or higher is
considered critical.
Standard Deviation (SD): The S.D. of the Z-score provides information on the spread of
the distribution and the quality of the anthropometric measurements done for a survey.
In the reference population, the standard deviation (S.D.) of the Z-score distribution for
height-for-age and weight-for-height is 1.0. A Z-score S.D. that is lower than 0.9
indicates that the distribution is more homogeneous or has less variation compared to
the reference distribution. A Z-score S.D. substantially greater than >1.0 indicates that
the distribution has a wider spread than the reference. A Z-score S.D. <0.80 or >1.3 is
suggestive of inaccurate anthropometric measurements and /or inaccurate age
information.
Data Quality: During data cleaning, records with potentially erroneous data will be
excluded from analysis based on the following standard Z-score cutoffs developed by
WHO (WHO, 1995):
- height-for-age Z-score (HAZ) <-5.0 or >3.0
- weight-for-age Z-score (WAZ) <-5.0 or >5.0
- weight-for height Z-score (WHZ) <-4.0 or >5.0
Box 2. BODY MASS INDEX
Adult nutritional status is assessed by calculating the Body Mass Index (BMI) from the
weight and height of non-pregnant women included in the survey (BMI= Weight
(kg)/Height2 (m)). A BMI below 18.5 indicates underweight or thinness. A BMI greater
than 25.0 indicates overweight which can also be categorized by grade as follows
(WHO, 1995). Although a BMI < 18.5 is considered underweight a BMI of 17 or < is
considered a more valid cut off point for chronic energy deficiency.
Underweight <18.5
Normal weight - 18.5-24.9
Overweight - 25-29.9
Obesity  30
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PNG National Micronutrient Survey 2005
5.4 Anemia
Anemia will be evaluated by photometric method using the HemoCue Hemoglobin
system on small blood samples collected by finger stick. This method has shown
satisfactory accuracy and precision in laboratory evaluations using standard methods. A
major advantage of the battery-operated HemoCue photometer is that it readily displays
hemoglobin levels with a delay of less than one minute and avoids complicated handling
of blood samples in harsh field conditions.
Cut-offs for anemia depends on the age and sex of the person. Anemia is defined as
follows:
Age-sex group
Definition of anemia
Children 0-59 months of age
< 11g/dL
Children 6-12 years of age
<11.5 g/dL
Non-pregnant women of child-bearing age <12.0 g/dL
Pregnant women
<11.0 g/dL
Adult men
<13.0 g/dL
(WHO 2001)
For prevalence estimates of anemia based on hemoglobin, the hemoglobin values will
need to be adjusted for altitude (CDC, Morbidity and Mortality Weekly Report, 1998).
The adjustment for altitude is shown below.
Increase in cut-off
Altitude (meters)
point defining anemia (g/dL)
< 1000
0
1000-1499
0.2
1500-1999
0.5
2000-2499
0.6
5.5 Iron status and Iron deficiency anemia
Dried blood spots (DBS) will be used to analyze TfR, CRP, AGP and retinol content.
Using DBS specimens offers substantial advantages in collection and handling of
compared with serum and plasma in PNG, where maintaining a cold chain for serum
24
PNG National Micronutrient Survey 2005
specimens would be almost impossible. Moreover, collection of DBS specimens avoids
venipuncture which may be difficult in field settings.
Iron deficiency will be defined using transferring receptor (TfR). For all target groups,
iron deficiency is defined as a TfR value >8.3 μg/mL1. Iron deficiency anemia will be
defined as elevated TfR (>8.3 μg/mL) together with hemoglobin value below the
appropriate group-specific cut off for anemia.
5.6 Vitamin A status
A serum retinol concentration less than <20 µg/dL (0.70 µmol/L).0.35 mol/L defines
vitamin A deficiency (VAD). The rate of VAD among preschool-age children as an
indicator of VAD has been raised to >15% % in young children (<6 y)2. Serum retinol
levels of 0.35 – 0.69 mol/lL (10-19 ug/dL) indicate vitamin A deficiency disorders
(VADD)3. The term VADD was introduced to cover all physiological disturbances caused
by low vitamin A status, including clinical signs and symptoms. The most vulnerable
groups to VADD are infants, young children and pregnant and lactating women.
Because retinol-RBP are decreased during bacterial infections, we will interpret retinol
levels using an acute phase indicator (CRP) according to Lancet 2003; 362: 2052–58 as
follows :
If CRP is elevated, adjust retinol values upwards by 25% (evidence of recent infection)
Or use the retinol values of only those individuals classified as healthy a the time of the
survey (normal CRP) in calculating the prevalence rates of VAD and VADD
Retinol data will be presented both ways. However, acute phase protein response may
be impaired in severely undernourished persons. This will be considered in the data
analysis.
5.7 Iodine status
Urinary iodine values are expressed as micro grams per deciliter (g/dl). Levels of
urinary iodine within an individual vary daily and even during a given day. Consequently,
classification of iodine deficiency as a public health problem is done on the basis of
median values in population groups rather than as a prevalence rate, as with vitamin A
deficiency and anemia. A median urinary iodine value of less than 10.0 g/dl defines
1
Human Transferrin Receptor: An in vitro enzyme immunoassay. Ramco Laboratories,
Inc. kit insert. Catalog Number TF-94.
2
Sommer A and Davidson FR, Assessment and control of Vitamin A deficiency: The Annecy
Accords, J Nutr 132: 2845S-2850S, 2002
3
WHO. Indicators for assessing vitamin A deficiency and their application in monitoring and
evaluating intervention programmes. 1996
25
PNG National Micronutrient Survey 2005
iodine deficiency as a problem in a population.
Table5. Epidemiological criteria for assessing iodine nutrition based on median urinary
iodine levels in school aged children.4
Level of importance as a public health problem
Median value (g/dl)
Excessive iodine (risk of adverse health consequences)
> 30.0
More than adequate (risk of iodine-induced hyperthyroidism within 510 years after introduction of iodized salt in susceptible groups)
20.0-29.9
Adequate (optimal)
10.0 – 19.9
Insufficient (Mild iodine deficiency)
5.0 – 9.9
Insufficient (Moderate iodine deficiency)
2.0 – 4.9
Insufficient (Severe iodine deficieny)
< 2.0
5.8 Malaria
Plasmodium falciparum is the most common cause of malaria infection in PNG. All
women and children participating in the survey, whether febrile or not, will have thick
smears made from capillary blood samples collected after the same fingerstick used to
obtain blood for hemoglobin measurement. Presence of P. falciparum trophozoites, the
asexual erthrocytic development stage of the parasite, and the level of parasitemia will
be recorded. Presence of P. falciparum gametocytes, the sexual erythrocytic stage and
the level of parasitemia will also be recorded. Infections with Plasmodium malaraie and
Plasmodium vivax are also found in PNG. If possible, microscopy will be used to
differentiate among the three Plasmodium species.
5.9 Hookworm
The prevalence of hookworm will be measured for each child between 24-59 months of
age. The hookworm results will also be analyzed with the hemoglobin data to assess
the correlation between hookworm infection and anemia.
6. Specimen Processing
4
The values in the table are for school aged children. A forthcoming WHO consultation
will hopefully give more guidance as to how to interpret values in women.
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PNG National Micronutrient Survey 2005
6.1 Hemoglobin cuvettes
Hemoglobin will be assessed in the household using the HemoCue. Quality control of
the HemoCue instrument will be ensured by using the control cuvette for each specific
instrument before the instrument is used each. Liquid controls (HemoCue AB,
Angelholm, Sweden) will also used at the beginning and end of each day as further
assurance of the quality of HemoCue readings in areas where a cold chain will be kept.
Log sheets of all the quality control measurements will be kept. For most PSUs where
there is no cold chain the control cuvette will be used for quality assurance purposes
6.2 DBS processing
At each household, fresh DBS specimens will be put aside to dry. During travel between
households, DBS specimens will be placed in a microscopy slide box for protection from
light and insects. In the evenings the survey team will pack the dry DBS filter papers
between weighing papers and put them in low gas permeable bags with desiccant packs
and a humidity monitor card. These bags will then be stored in an opaque bag to reduce
light exposure. Because the buildup of humidity can damage the quality of the sample,
survey team members will check the humidity monitor card in each bag of stored DBS
specimens each evening and replace the dessicant packs if the card shows any color
changes.
6.3 Malaria slides
After the HemoCue cuvette has been filled and the DBS specimen obtained, the
remaining drop of blood will be smeared onto a microscopy slide for later microscopic
inspection for malaria infection. At the household, the malaria slide will be left
horizontally to dry before it is inserted into the slide box for transport and storage.
6.4 Stool
After a stool specimen is collected in a larger cup, one cubic centimeter of stool will be
transferred from the collection cup to the stool collection tube containing 9 cc of polyvinyl
alcohol (PVA). The stool will be vigorously agitated in order to mix the specimen with the
PVA after the cap is screwed on and tightly sealed with parafilm.
6.5 Urine
Urine samples will be collected in screw top urine collection cups. Each evening, survey
team members will transfer at least 1.5 mL urine sample to each of the 2 pre-labeled
cryovials using disposable pipettes. The cryovials will not be overfilled (no more than
1.8 mL) and sealed by screwing the caps on tightly The pipette and urine collection
cups will be discarded in the biohazard bag.
6.6 Salt
15 grams of salt will be collected from the house. Salt should be well mixed prior to
collecting the sample. The salt should be put in a pre-labeled plastic bag.
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PNG National Micronutrient Survey 2005
7. Lab Procedures
7.1 TfR and CRP
TfR and CRP will be analyzed on the DBS specimens by the staff at SEAMEO
TROPMED Regional Center for Community Nutrition (RCCN) in Jakarta using a newly
developed EIA method. A subset of the DBS specimens will be sent to the micronutrient
laboratory at CDC and to the laboratory at Craft Technologies to be analyzed for TfR
and CRP.
7.2 Retinol
The vitamin A DBS will be sent to Craft Technologies for assessment using HPLC with
UV/visible spectrophotometry. A sub sample will also be analyzed at UPNG (serum) and
CDC (serum and DBS) using similar methods.
7.3 Malaria
UPNG will perform the malaria analysis by standard microscopy with results expressed
as a semi-quantitative parasite load.
7.4 Hookworm
Stool samples will be assessed using centrifugation concentration and microscopy.
7.5 Urinary iodine
Urine samples will be analyzed for urinary iodine at UPNG using the ammonium
persulfate digestion with spectrophotometric detection of the Sandell-Kolthoff reaction. In
order to assure the quality of the method to assess urinary iodine levels the laboratory,
UPNG has enrolled in CDC’s quality assurance program EQUIP and in the Institute of
Clinical Pathology and Medical Research (ICPMR)’s Urinary Iodine Quality Assurance
Program. The laboratory at UPNG is also working with CDC on its internal quality control
program.
7.8 Salt
Samples will be collected and transported to Port Moresby to the UPNG laboratory for
salt iodine analysis using the WYD Iodine Checker, which quantitatively measures the
salt iodine content on the basis of a colorimetric method. Adequately iodized salt at the
household level must contain >15 ppm iodine (ICCIDD, UNICEF, and WHO, 2001).
Prior to analysis of survey salt samples, UPNG will establish an internal QC program for
salt iodine testing and also participate in an EQA program for salt iodine. EQA programs
for salt iodine include one managed the China National Reference Laboratory and a
second run by INCAP in Guatemala.
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PNG National Micronutrient Survey 2005
8. Data entry and analysis plan
During the survey, questionnaires will be collected and entered into computer files using
EpiInfo. Questionnaires will be sent to a central office in Port Moresby where the data
will be entered.
Any errors in completing questionnaires will be corrected in the field when possible. The
team leader will be responsible for checking the data collection forms in before leaving
the household. To reduce computer data entry error, the entry screen will be
programmed to accept only codes within a predetermined range for most variables. All
data will also be double entered and verified at the central location.
Once the data is entered and the data sets are clean, the analysis of the questionnaire
and the FRAT will be done by the national survey coordinator and CDC staff. Results of
the biochemical indicators will be added to the analysis once the data are returned from
the various laboratories (CDC, UPNG, Craft Technologies, SEAMEO TROPMED
Regional Center for Community Nutrition (RCCN).
Please see appendix 3 for a description of the provisions for protecting the privacy and
confidentiality of participants.
9. Dissemination of study results
Dissemination of study results will take place in four ways:
Detailed study report: for professionals working in the field of nutrition and health at the
academic and policy levels. This report will include all the details of the study, including
detailed background, methodology, results and interpretation of the results. This report
will be needed for a better understanding of the prevalence and causes of micronutrient
deficiencies in PNG and will be used for the development of adequate national policies
and programs.
Easy to read summaries: for people interested in nutrition and health at international,
national and district level. These summaries will mainly focus on the results and
interpretation of the resultsand will be available as national and regional data. Although
each of the provinces in the country will be included in the survey the precision will
besufficient to interpret the results at only national and regional levels. The summaries
will provide a better understanding of the causes and consequences of micronutrient
deficiencies in PNG. To increase readability, this document will convey the results of the
PNGNMS using mainly graphs and other visuals with minimal text
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PNG National Micronutrient Survey 2005
Press briefing kit: for journalists and others responsible for media communications. This
kit will assist journalist in informing the population of Papua New Guinea of the results
and significance of the PNGNMS. This press briefing kit will include background
information on micronutrient deficiencies (including copies of videos developed by
UNICEF/MI), a summary of the study results, an explanation of the consequences of the
micronutrient deficiencies discovered in the population of Papua New Guinea The kit will
also include materials directed to specific segments within the population, such as
women and children (see also number 2. above).
High level advocacy meeting: for major policy makers. The objective of this meeting is
to disseminate the results and to create awareness on micronutrient deficiencies, its
causes and required programmatic responses among those that are responsible for
implementing in place policies and programs. Examples of such persons include highranking Government officials, management personnel of companies producing fortifiable
foods, and representatives of major donor organizations and countries. This one day
meeting should be followed by a inter-sectoral program planning meeting to work out the
recommendations made at the advocacy meeting and plan the programmatic follow up
(supplementation, fortification, dietary diversification and health interventions).
10. Time frame
A detailed breakdown of the survey timeline can be found in annex 4.
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PNG National Micronutrient Survey 2005
Appendix 1: List of publications by principal investigators
Principal investigators include:
Gilbert Hiawayler, Victor Temple, Florence Addo, Wila Saweri, Bradley Woodruff, Katie
Tripp, Rosemary Schleicher, Tracy Dearth Wesley and Bridgette Bowen.
Florence Addo
Gilbert Hiawayler
Wila Saweri
Saweri W. 2001.The rocky road from roots to rice. A review of the changing food
situation in Papua New Guinea. Papua New Guinea Medical Journal; 44 (3-4): 151-163.
Temu PI and Saweri W. 2001. Nutrition in transition. In: Bourke R M, Allen M G and
Salisbury J G, ed. Food security for Papua New Guinea, Proceedings of the Papua New
Guinea Food and Nutrition 2000 Conference, PNG University of Technology, Lae, 26-30
June 2000. ACIAR Proceedings No 99. Australian Centre for International Agricultural
Research, Canberra, Australia: 395-406.
Mittendorfer E and Saweri W. 1999. Nutrition country profile of Papua New Guinea.
www.fao.org. FAO, Rome
Saweri W. 1998. Development of health promoting schools in Papua New Guinea.
Australian Journal of Nutrition and Dietetics; 55 [I Supplement]: S45-S47.
Friesen H, Vince J, Boas P, Danaya R, Mokela D, Ogle G, Asuo P, Kemiki A, Lagani W,
Rongap T, Varughese M and Saweri W. 1998. Infant feeding practices in Papua New
Guinea. Annals of Tropical Paediatrics; 18: 209-215.
Amoa B, Attah Johnson F and Saweri W. 1997. Report on Iodine Deficiency Disorders in
Huon and Memyamya Districts of Morobe Province, Papua New Guinea. Department of
Health/Unicef, Waigani, Papua New Guinea.
Victor Temple
Temple V. J., Mapira P, Adeniyi K. O. and Sims P. “Iodine Deficiency in Papua New
Guinea” Journal of Public Health (Accepted for publication: March 2005)
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PNG National Micronutrient Survey 2005
Temple V.J. and Masta A. “Zinc in Human Health” PNG Medical Journal (In Print).
Temple V. J. (2003) “Iodine Deficiency Disorders (IDD): Focus on the process and
significance of monitoring in PNG” Medical Science Bulletin, 28 – 32.
Temple V. J. (2003) “Zinc: The controversial trace element” Med Science Bulletin, 41 –
44.
Temple, V.J.; Badamosi, E.J.; Ladeji, O.; Solomon, M. and Gowok, H.G. (1996).
“Proximate chemical composition of three locally formulated complementary foods” West
African Journal of Biological Sciences Vol. 5. No. 2; 134 –143.
Ibrahim, L.M.; Temple, V.J.; Badamosi, E.J.; Obatomi, A. and Greeley, S. (1996).
“Nutrient composition of three locally prepared weaning foods” Bioscience Research
Communications Vol. 8, No. 2; 71 – 76.
Temple, V.J; Agye, E.O.; Badamosi, E.J.; Olomu, N.I. and Odewumi, O. (1996). “Serum
levels of some biochemical parameters in pre-school age children” West African Journal
of Biological Sciences, Vol. 5, No. 1; 119 – 127.
Temple. V.J.; Ighogboja, I.S. and Okonji, M. C. (1994). “Serum vitamin A and betacarotene levels in pre-school age children” J. of Tropical Paediatrics, Vol. 40; 374 –375.
Published Abstracts:
Mapira P, Temple VJ and Adeniyi KO (2004). Using Anthropometric Data to Assess the
Nutritional Status of Children (6 – 12 yrs) in Hella Region, SHP, PNG. Medical Society of
PNG 40th Annual Medical Society Symposium, Sep 2004, pp 38.
Mapira P, Temple VJ and Adeniyi KO (2003). Urinary Iodine Concentration In Children
(6 – 12 years) in the Hella Region (Tari and Koroba Districts) In Southern Highland
Province of PNG. Medical Society of PNG 39th Annual Medical Society Symposium, Sep
2003, pp 46.
Mapira P, Temple VJ, Adeniyi KO (2003). Assessment of Iodine concentration in
household salt and per capita consumption of salt in the Hella Region (Tari and Koroba
districts) in the Southern Highlands Province PNG. Medical Society of PNG 39th Annual
Medical Society Symposium, Sep 2003, pp 44.
Bradley Woodruff
Dowell SF, Toco A, Sita C, Piarroux R, Duerr A, Woodruff BA. Health and nutrition in
centers for unaccompanied refugee children: experience from the Rwandan refugee
crisis. JAMA 1995;273:1802-1806.
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Hassan K, Sullivan KM, Yip R, Woodruff BA. Factors associated with anemia in refugee
children. J Nutr 1997;127:2194-2198.
Tomashek KM, Woodruff BA, Crawford CG, Bloland P, Mbaruku G. Randomized
intervention study to determine the most effective method to treat moderate anemia in
refugee children in Kigoma Region, Tanzania. Am J Trop Med Hyg 2001;64:164-171.
Blanck HM, Bowman BA, Serdula MK, Khan LK, Kohn W, Woodruff BA. Angular
stomatitis and B vitamin status among adolescent Bhutanese refugees living in
southeastern Nepal. Amer J Clin Nutr 2002;76:430-435.
Woodruff BA, Duffield A. Anthropometric assessment of nutritional status in adolescent
populations in humanitarian emergencies. Eur J Clin Nutr 2002;56:1108-1118.
Woodruff BA, Blanck HM, Slutsker L, Cookson ST, Larson MK, Duffield A, Bhatia R.
Anemia, iron status, and vitamin A deficiency among adolescent refugees: surveys in
Kenya and Nepal. (submitted for publication)
Hailemeskal H, Woodruff BA, Yahmed SB. Rapid health assessment. World Health: the
Magazine of the World Health Organization 1996;49(6):28.
Cookson ST, Woodruff BA, Slutsker L. Prevalence of anemia and low body-mass index
among adolescents 10-19 years of age in refugee camps in Dadaab District, Kenya.
November 1998.
Woodruff BA, Slutsker L, Cookson ST. Prevalence and causes of anemia and
prevalence of low body-mass index in adolescents 10-19 years of age in Kakuma camp,
Kenya. April 1999.
Woodruff BA, Duffield A, Blanck H, Larson MK, Pahari S, Bhatia R. Prevalence of low
body mass index and specific micronutrient deficiencies in adolescents 10-19 years of
age in Bhutanese refugee camps, Nepal, October 1999.
Woodruff BA. Older people, nutrition, and emergencies in Ethiopia - commentary. Field
Exchange 2001;14:28.
Woodruff BA. Measuring mortality rates in cross-sectional surveys: a commentary.
Field Exchange 2002;17:16.
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Woodruff BA, Reynolds M, Tchibindat F, Ahimana C. Nutrition and Health Survey:
Badghis Province, Afghanistan. February – March 2002.
Katie Tripp
Tracy Dearth-Wesley
Bridgette Bowden
Rosemary Schleicher
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Appendix 2: Sample Size Breakdown
Target group
Indicator
Estimate Stratumd
specific
prevalenc half CI
e
Sample
DEFF
size per
stratum if
SRS
Sample
size per
stratum if
cluster
sampling
Sample
Individual
size
needed (all nonresponse
4 strata)
No. per HH Non
Total
number
response HH incl.
nonfor HH
response
Total
number
of HH for
4 strata
Specimens
if sample
size = 1600
HH
Difference
between
actual &
needed
sample size
HH
Salt HH
0.5
0.12
67
4.5
300
1201
0%
1
10%
333
1,334
1440
240
0.5
0.10
96
2
192
768
20%
0.7
10%
381
1,524
806
38
0.5
0.10
96
2
192
768
20%
0.7
10%
381
1,524
806
38
Malaria
0.5
0.12
67
3
200
800
20%
0.7
10%
397
1,588
806
6
Vitamin A
deficiency
0.5
0.10
96
2
192
768
20%
0.7
10%
381
1,524
806
38
Wasting
0.1
0.05
138
1.5
207
830
10%
0.7
10%
366
1,463
907
77
Stunting
0.5
0.10
96
1.5
144
576
10%
0.7
10%
254
1,016
907
331
Hookworm
0.5
0.15
43
3
128
512
30%
0.5
10%
407
1,626
504
-8
0.5
0.10
96
2
192
768
20%
1.37
10%
195
779
789
21
Anemia
0.5
0.10
96
2
192
768
20%
1.37
10%
195
779
789
21
Malaria
0.5
0.12
67
3
200
800
20%
1.37
10%
203
811
789
-11
BMI <17
0.1
0.05
138
1.5
207
830
10%
1.37
10%
187
748
888
58
BMI >25
0.5
0.10
96
3
288
1152
10%
1.37
10%
260
1,039
888
-265
Urinary
0.5
0.10
96
2
192
768
20%
1.37
10%
195
779
789
21
Anemia
0.1
0.05
138
1.5
207
830
25%
1.5
10%
205
820
810
-20
BMI < 17
0.1
0.05
138
1.5
207
830
10%
1.5
10%
171
683
972
142
BMI > 25
0.1
0.05
138
1.5
207
830
10%
1.5
10%
171
683
972
142
Children 6-59 Anemia
months
Iron
deficiency
Children 2459 months
Women 15-49 Iron
years
deficiency
Iodine
Men > 18
years
36
PNG National Micronutrient Survey 2005
Appendix 3: Supplemental information for protection of human research
participants
Description of risks (physical, social, psychological) to the individual
The only physical risk of participation in nutrition assessment surveys includes only
those of fingerstick and phlebotomy. Both procedures involve some discomfort but there
are only very rarely any adverse risks associated. Only qualified survey team members
are allowed to perform these procedures, and these personnel monitor survey
participants for some minutes after the procedure to ensure that there is no bleeding,
serious bruising, or vasovagal syncope.
Social and psychological risks are minimal. No sensitive questions will be asked during
interviews. Although in many communities, privacy is difficult to achieve during data
collection, all possible efforts will be made to keep participants responses and findings
as private as possible. No survey data will ever be connected to identifying information
in a report, manuscript, or verbal debriefing.
Anticipated benefits of participating in the survey
As mentioned above, participants will learn the results of the hemoglobin and may
benefit from referral. In addition, indirect benefits to survey participants include the
benefits accrued to the entire population as a result of the interventions based on the
survey findings.
Description of the potential risks to anticipated benefit ratio
The risk of participation includes only the minimal risk of finger stick and phlebotomy for
a sub sample of the survey participants. The benefit includes the implementation of
critical food and nutrition programs in population with potentially serious nutritional
deficiencies.
Justification for involving vulnerable participant populations
Protein-energy malnutrition and most micronutrient deficiencies occur in vulnerable
populations, such as young children and women of child-bearing age. As a result,
assessment of these problems must be directed to these vulnerable populations to
achieve the maximum likelihood of detecting these conditions if they are present in the
population.
Procedures for implementing and documenting informed consent
Prior to enrollment, verbal consent will be obtained from all adults and from parents or
caretakers of children selected for participation in the survey. The explanation of the
survey will include the purpose of the survey, the types of questions which will be asked,
37
PNG National Micronutrient Survey 2005
the procedure for weighing and measuring children 6-59 months of age and women of
child-bearing age and a description of the type and quantity of biologic specimens to be
obtained as well as the procedures necessary for specimen collection. The granting of
verbal consent will be indicated on the data collection form. Written consent is not
practical in most circumstances due to high rates of illiteracy, the risks to survey
participants are very small, and the time necessary for extensive explanation of all facets
of the survey is not available.
Survey team members will advise survey coordinators regarding the culturally most
appropriate way to explain the survey and obtain verbal consent.
Procedures for implementing and documenting the assent process of children
Because the children included in most nutrition assessment surveys are less than 5
years of age, assent is not required. Consent will be obtained from the mothers or
guardians of all children in the survey.
Provisions for protecting privacy/confidentiality
The paper data collection forms completed in the field will not contain identifying
information. As a result, the computer dataset resulting from data entry of these forms
will also not contain any identifying information. Data collection forms and laboratory
specimens are matched by recording on both forms and specimens a numeric code
number which is specific for each household and individual participant. In this survey a
sample list, which lists all the households or individuals selected for that cluster (cluster
control form) will be created when the final selection of households or individuals is
made during the sampling process. These cluster control forms will contain both
identifying information and the numeric code described above, and thus can serve as a
key to match the code numbers to specific individual participants. At the end of the
survey, these sample lists will be destroyed or permanently stored separately from the
paper data collection forms. Only authorized survey coordinators will have access to the
sample lists and data collection forms.
38
PNG National Micronutrient Survey 2005
Appendix 4: Time Frame
Task
Jul
Aug Sep Oct Nov Dec Jan Feb Mar Apr May Jun Jul
Debrief UNICEF-PNG
Debrief UNICEF-EAPRO and INMU
Calculate final sample size (1600)
Create list of equipment and supplies
Select clusters
Identify and engage survey manager
Prepare final budget
Check with Neil Craft and Juergen Erhard re laboratory testing
Identify lab person at CDC to travel to PNG
Run EQUIP at PNG laboratory
Discussion with INCAP
Establish quality assurance
Discuss potential survey workers
Negotiate for cheap flights and other transport
Investigate cost of anthropometric equipment
Funds arrive
Order supplies and equipment
Identify potential training facilities
Develop data collection forms
Translate and backtranslate questionnaire questions?
39
Aug Sep
PNG National Micronutrient Survey 2005
Develop social mobilization plan
Request authorization to import supplies and equipment
Discuss data entry and analysis with NSO and IMR
Pre-test questionnaire questions
Submit protocol to IMR for ethical clearance (Nov 11)
Finalize list of survey workers and invite them to training
Develop social mobilization materials
Organize supplies for pilot
Start to organize training
Check status of supplies and equipment
!!!
Plan training curriculum
Develop survey manual
Identify trainers
Identify expert supervisors for first few clusters
Identify secretariat for training
Check status of supplies and equipment
!!!
Pilot test procedures
Check status of supplies and equipment
!!!
Develop data entry system
Plan training, incl standardization, facility, accomodation of
trainees, etc.
Begin preparation of report
40
PNG National Micronutrient Survey 2005
Ensure ALL supplies and equipment have arrived and are
functioning
!!!
Training (week 2 or 3 of March)
Training for data entry
Data collection
?
Data entry
Laboratory specimen analysis
Data cleaning
Data analysis
Submit final report
Workshop to discuss results
41
PNG National Micronutrient Survey 2005
Appendix 5
Measurement of Micronutrients in Dried Blood and Serum Spots
Validation in Potentially Deficient Populations
Background
The concentrations of vitamin A (retinol), ferritin, soluble transferrin receptor (TfR), and C-reactive
protein (CRP) circulating in serum are commonly used parameters for assessing vitamin A and
iron status. Preparing and transporting serum for these tests is not a trivial issue in developing
countries. Access to centrifuges, refrigerators, freezers, cold packs and dry ice is often
impractical. There remains a critical need for simple and affordable laboratory methods for
assessment of micronutrient status in populations at risk for deficiency.
Dried blood spots (DBS), collected and processed in the field and tested at distant laboratories,
offer a simple and affordable method for obtaining and transporting specimens. DBS are
currently being used by one commercial lab in the United States for nutritional testing, Craft
Technologies (Wilson, NC). This lab has a strong track record in the development and use of
methodologies for assessing micronutrient status in deficient populations.
The major advantages of DBS are 1) elimination of the need for venous blood sampling, which is
often a technical challenge in infants and young children (typically DBS tests require smaller
quantities of blood than serum-based tests), and 2) convenience and low cost transportation of
specimens on filter paper blood collection devices at ambient temperature.
A Technical Report (1) reviewing the quality, completeness, analytical approach, and results of
the process followed for field validation of the Craft Technologies vitamin A DBS method,
particularly within the low range commonly found in populations at risk of vitamin A deficiency,
noted that there are no data on the decomposition rate of blood spot retinol in children when their
serum retinol concentrations are less than 1.05 µM (30 µg/dL). The report suggested that the
Craft method needs to be evaluated by a third-party laboratory that has no financial interest in the
outcome. They also suggested that the DBS methodology must be tested in three to five distinct
“real world” settings. Further research into the utility and reproducibility of the DBS methodology
in different countries is critically needed. Research needs include the intra-individual variation,
ramifications of the poorly collected DBS, data about the volume of serum that is needed for
analysis, and the effect of freeze-thaw cycles on results.
These and other questions can be raised concerning the use of DBS for other markers of nutrition
(or infection) status such as ferritin, retinol binding protein (RBP), TfR, alpha1-acid
glycoprotein (AGP) and CRP. Few of the DBS assays for these markers have been well
validated in the field. A dried serum spot (DSS) assay for ferritin (2) offers the advantage of
shipping samples at ambient temperature, and fulfills WHO recommendations for iron status
testing (May, 2004 meeting not yet published), but has not been widely used in the field. A
portable centrifuge would still be required for preparing serum, but transportation of specimens to
the lab is simplified. This method similarly needs to be evaluated under field conditions by others.
42
PNG National Micronutrient Survey 2005
CDC is often involved in nutrition assessment surveys in developing countries. We are often
asked whether the DBS methods are valid. Typically we review the literature and contact labs
that perform such assays to request validation information. Often validation information is not
available, or is not comprehensive enough to evaluate the methodology.
The overall objective of this protocol is to perform ancillary research based on non-research
nutrition assessments in countries performing national nutrition surveys. We foresee that we
might have the opportunity to perform a direct comparison of conventional serum testing versus
dried blood spot and dried serum spot testing 1-3 times per year. The nutrition assessments are
non-research public health need surveys undertaken with the goal to make recommendations
about nutrition policy. The populations involved in these surveys generally suffer multiple
micronutrient deficiencies.
Small method validation research projects would be performed using convenience samples from
the nutrition surveys. The participants would either be part of the survey, members of the survey
household not directly included in the survey, or field staff who volunteer for this research. We
plan to take capillary and venous blood, and prepare dried blood spot and dried serum spot
samples from persons at locations within the countries where access to a centrifuge, freezer and
dry ice is readily available. Each additional study after the first one, which is detailed in this
protocol, would be written up as an amendment to this protocol using CDC IRB form 1252.
We anticipate collecting up to 200 pairs of serum-DBS-DSS samples in each of 3-4 regions
around the world in populations with varying degrees of micronutrient malnutrition. It will likely
take 1-2 years to collect this information. We would comparatively test for as many nutritional
indicators as possible including vitamin A, retinol binding protein (RBP), ferritin, TfR, AGP and
CRP. DBS RBP which is the carrier protein for vitamin A will be compared with vitamin A and a
new RBP kit assay. DBS AGP data will be compared with CRP data (infection markers),
although the results are not expected to be well-matched as the time course differs for each
marker depending on the course of the infection. If possible, the CDC lab will develop a test for
AGP in serum. In some studies we would include whole blood zinc protoporphyrin to confirm iron
deficiency using an independent test. The ZP test requires one drop (20 uL) of whole blood. In
some studies we would exchange samples with labs that are performing DBS or DSS assays to
compare results and provide quality assurance information for the nutrition survey. The
amendments would specify such details about the particular study. Assurances and informed
consent forms would be included at the time each amendment is proposed.
Protocol Details
The first study will take place in Papua New Guinea (PNG) in Spring, 2005. Subjects will be
selected on the basis of whether they are willing and able to donate a venous sample (<30 cc = 2
tablespoons) and meet the following age and gender criteria –
Group
Gender
Age
EDTA Whole Blood
Serum
Finger stick
Children
♂ or ♀
24-59 months
venous (<15 cc)
venous blood (<15 cc)
4-5 drops
Adult
female
18-49 years
venous (<15 cc)
venous blood (<15 cc)
4-5 drops
Adult
male
> 18 years
venous (<15 cc)
venous blood (<15 cc)
4-5 drops
43
PNG National Micronutrient Survey 2005
Analtyes will be tested at the following locations –
Analyte
Matrix
Lab
AGP
DBS
University of Indonesia
CRP
serum
CDC Nutrition Lab
CRP
DBS
Craft Technologies
CRP
DBS
University of Indonesia
Ferritin
serum
CDC Nutrition Lab
Ferritin
DSS
CDC Nutrition Lab
Ferritin
DSS
Penn State University
RBP
serum
CDC Nutrition Lab
RBP
DBS
CDC Nutrition Lab
RBP
DBS
University of Indonesia
TfR
serum
CDC Nutrition Lab
TfR
DBS
CDC Newborn Screening Lab
TfR
DBS
Craft Technologies
TfR
DBS
University of Indonesia
VIA
serum
CDC Nutrition Lab
VIA
serum
University of PNG
VIA
DBS
CDC Nutrition Lab
VIA
DBS
Craft Technologies
ZP
blood
University of PNG
Finger stick blood will be collected in 4 blood spots to simulate the blood collection method that
will be used in the national survey in PNG. Each tube of whole blood (~15 mL) will be sufficient
to prepare approximately 600 blood spots (25 uL/spot). Each tube of serum (~ 7 mL) will be
enough for at least 50 tests on serum and 20 DSS (100 uL/spot) specimens. Sufficient numbers
of samples are needed for comparison of intra- and inter-day variability within and between labs.
Serum aliquots and dried blood and dried serum spots will be prepared in PNG. With one
exception, dried cards and serum will be shipped to CDC for repackaging and distribution. The
University of PNG serum aliquots will be transported directly to the lab from the survey collection
without shipment to the US.
Study subjects will be identified with the help of the PNG nutrition survey workers. The estimated
number of participants will range from 150-200 subjects. Subject information connected to the
samples will be limited to gender, age and hemoglobin. Hemoglobin information is necessary for
selecting calibration spots for the DBS assays. Trained medical or laboratory personnel will
collect clinical samples using standard protocols for specimen collection, handling, storage, and
shipment to CDC for further distribution with the exception of ZP testing which will be done each
day at the University of PNG. Survey staff will use standardized consent forms to obtain consent
44
PNG National Micronutrient Survey 2005
from adults and from the parents of children younger than 18 years of age (see attachment).
Standardized assent forms will be used to obtain assent to participate from children less than 18
years old (see attachment).
A zinc protoporphyrin (ZP) test will be used to independently evaluate iron status. This test
requires 1 drop of blood. The rationale for this test is that WHO guidelines (May, 2004 meeting
not yet published) found insufficient information to recommend this test for iron status. From a
field work point of view, this test is simple, cheap and the instrument can be used in-country using
a 12 volt battery. Although not part of the serum-DBS-DSS comparison, this information will add
great value to this research project. The results from the DBS, DSS and serum for iron indicators
(TfR and ferritin) will be compared with ZP results. Field data will be accumulated with each
research protocol.
In the event of unexpected findings for any indicator, CDC will immediately relate this information
to the community via the PNG Nutrition Survey Coordinators located at MOH, UNICEF and the
University of PNG, and through contact with the University of PNG and CDC Institutional Review
Boards.
References
1. Dried blood spot retinol and retinol-binding protein concentrations using enzyme
immunoassay as surrogates of serum retinol concentrations. Sherry A. Tanumihardjo, William S.
Blaner, Tianan Jiang. MOST Technical Report, June 2002
2. Ahluwalia N, de Silva A, Atukorala S, Weaver V, Molls R. Ferritin concentrations in dried serum
spots from capillary and venous blood in children in Sri Lanka: a validation study. Am J Clin Nutr.
2002 Feb;75(2):289-94.
45
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