Environmental Engineering Reference
In-Depth Information
Sample Size Estimation
Setting the level of confidence at 0.95 and a minimal detectable error of 0.05 around a
prevalence estimate, assuming the overall prevalence of zinc use to be 0.20 and adjust-
ing by 2.5 for design effect (DE), a minimum of 615 cases per population strata were
estimated to be required. The DE = 1+roh (k-1), where roh (rate of homogeneity) was
estimated to be 0.10 and k was arbitrarily set at 16 participants per cluster [9]. The
choice of 16 individuals per cluster represents a compromise between data collection
efficiency (larger number of participants per cluster) and reducing the DE (smaller
number of participants per cluster). Piloting indicated that our research team could, on
average, collect 16 cases in a day, but this would vary by time of year and the occur-
rence of diarrhea outbreaks.
Zinc Treatment Scale Up
Under the title “SUZY Project,” preparations and the eventual implementation of a
national campaign in support of zinc treatment for childhood diarrhea was carried out
over a period of 3 years (2003-2006). The campaign targeted children 6 months to 5
years of age. This was a national effort, involving several public and private agencies,
with coordination and financial support provided through the SUZY Project. There
were no parallel campaigns occurring. Within the Bangladesh Ministry of Health and
Family Welfare (MOHFW), a National Advisory Committee (NAC), chaired by the
Health Secretary, was created. This committee was represented by the primary health
care division of the MOHFW, the Bangladesh Pediatric Association, and country rep-
resentatives from WHO and UNICEF. An implementation subcommittee was created
to make specific recommendations to the NAC, including a zinc treatment policy
statement, over-the-counter and advertising permits, and private sector participation.
Private sector involvement included the selection of a pharmaceutical laboratory to
produce and distribute a dispersible zinc tablet formulation, a marketing agency, and
private provider groups, such as the Bangladesh Pediatric Association and the
Bangladesh Village Doctors Association. Inclusion of these professional associations
was critical given considerable doubt existed in the beginning about zinc safety and
over-the-counter sales.
Following the selection of a pharmaceutical laboratory (ACME Pharmaceuticals,
Ltd) a technology transfer from the French nutrition fi rm holding the patent for the dis-
persible zinc formulation (Nutriset Ltd) was arranged and eventually completed. Fol-
lowing the technology transfer, this included yearly scheduled quality control visits.
The ACME Pharmaceuticals then applied and obtained from the MOHFW Drug Ad-
ministration for the following in the sequence listed: approval of the dispersible zinc
tablet formulation, brand name (Baby Zinc) and packaging design, pricing (18 taka or
approximately US $0.25 for a 10-tablet blister pack), an over-the-counter waiver, and
a permit to advertise nationally on TV and radio.
Prior to initiating the national scale up several gaps in knowledge were identifi ed
and protocols prepared to provide the needed information. These included: (1) a phase
IV safety and side effects studies carried out among children attending the ICDDR,B
Dhaka hospital [10, 11]; (2) formative studies to better understand household diarrhea
 
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