The effectiveness bundling of zinc with

Oral Rehydration Salts (ORS) for improving

adherence to acute watery diarrhea
treatment in Ethiopia: cluster randomised
controlled trial

Supervisor
Dr. dr. Agustini Utari, Msi. Med, Sp. A(K)

1
.

ABSTRACT
Background

• evaluate whether
Zn purpose co-packing can enhance the joint
adherence to the treatment
Encourages use of the compares the cost effectiveness (CE)
products for diarrhea of two co-packaging options:
treatment ‘central’ and ‘health center (HC)’
level bundling.

3
Methods
• 8 district of 1. Central bundling
Cluster
Ethiopia 2. HC level bundling
randomize
• 32 health 3. Bundling without
d trial
center message
4. Status quo

• 176 children (6-59

months of age)
• Acute diarrhea

4
Result
The follow-up rate compared with the No significant
was 95.6 % ‘status quo’ arm, the difference was
joint adherences in observed
the ‘central’ and between ‘bundling
‘HC level’ bundling without message’
arms raised and the ‘status
substantially by quo’ arms
14.8 and 15.7
percentage points
(PP), respectively (P
< 0.05).
Conclusion
Bundling zinc with ORS using a pouch with instructional messages
increases adherence to the treatment. ‘HC level bundling’ is more CE than
the ‘central bundling’ approach.
DIARRHEA SECOND LEADING
CAUSE OF DEATH
7

18 % OF MORTALITY AND 13 % OF ALL DISABILITY-

ADJUSTED LIFE YEARS
78%
OCCURS IN AFRICA AND SOUTH EAST ASIAN
diarrhea is highly treatable.

Oral rehidration Zinc

suplementation Its recommend
salt that under-five
years old
• decreases the duration children
should receive
and severity of diarrheal 10–14 days of
zinc treatment for
episode diarrhea

• cut diarrhea related

mortality by nearly one
quarter
8
 ORS Zn = enhance access for treatment

On-pack
information
serve as education and communication tool.
.

background
 APPROACH : Readymade centrally bundled

Health Institution

Co-Packaging
Zinc and ORS APPROACH

Dispatched by health workers

 To evaluate co-
packing of zinc with
ORS using plastic
pouch can enhance
the joint adherence to
diarrhea treatment
PURPOSE
Compared the CE (cost
per unit of a defined
health outcome) from
‘centrally bundled’
and ‘health
center (HC)’.
 DESIGN

Cluster-randomised controlled trial with four

parallel intervention arms and an allocation
ratio of 1
 Distric of
Misrak Distric of
Badwacho Laelay
Maychew
Distric of Distric of
Tehuledere Enda
A. Inclusion:
Mehoni
1. Children 6-59 month
presented with diarrhea
in HC

Distric of Dedi B. Exclusion:

Distric of
1. Persistent diarrhea(14
Dera days or more)
PARTICIPANT
2. Bloody diarrhea or severe
dehydration
Distric of Aleta Distric of 3. They come from outside of
Dodola area and catchmen of
Wondo
HC

January until March, 2015

 1. Central bundling : Pre-bundled zinc and ORS with a pouch, had
instructional message intended for improving the rational use of Zinc-ORS
treatment,distributed to HCs

2. HC level bundling: Zinc, ORS and bundling with a pouch

distributed to the HCs, bundling by the health workers

INTERVENTION

3. Bundling without message: Zinc, ORS and plain pouches without

messages, distributed to the HCs and bundling by the health workers.

4. The status quo: Zinc and ORS co-administered without bundling.

INTERVENTION
OUTCOME
Level of joint adherence to zinc and ORS
treatment
Level of independent adherence to zinc
and ORS treatment
 SAMPLE SIZE

The sample size using for

assessing level of adherence
and cost effectiveness (CE)
using sample size calculation
formula for comparison means
and computed by GPower
The sample size was
computed as 704 children is
176 per each arm
 RANDOMIZATION
Four regions (Tigray, Amhara, Oromya
and SNNP)
4 HC having relative high patient
flow was selected
4 HC selected from each district were randomly
allocated four arms by lottery method
Two districts selected random
From each district
Based eligibity criteria , 22
Subjects were recruited from
each HC using quota sampling
technique
 BLINDING

NOT INVOLVE ANY KIND OF BLINDING

 STATISCAL METHOD

Analyzed Categorical
• SPSS 19.0 and variables
STATA SE 12 • Chi-Square test
software

Numeric Level of
measure, adherence
depending on across the four
normality intervention
• ANOVA or Kruskal • mixed effects
Wallis test multiple linear
regression model
With the intension of making macro
level
comparisons, the hypothetical total
annual expenses of the country for
treating acute watery diarrhea were
estimated by multiplying the unit cost for
treatment by the expected number of
health institution based diarrhea
treatments per annum.
RESULTS
Characteristic
Characteristic Mean ratio
between boys
and girls:

s of the
the Houshold health
index:

respondents
respondents Mean duration
of initial
interviews and
1,22 follow ups :
Boys > Girls From poor
family 30,1% 12 Days
Varies between
10 – 23 days
Characteristics
of the
respondents
and the cases during the baseline
survey in the four arms of the study,
Jan-Mar 2015
Diagrams
of the
Study
Severity
Severity Children from the
and
and ‘HC level bundling’
arm appear to
duration
duration of
of have a longer and
the
the more frequent
diarrheal
diarrheal diarrheal episodes
and a higher
illness
illness proportion exhibited
signs of dehydration
The assumption: The fact:
35,9 -
44,4
%
Nevertheless, the figures were not
statistically different across the arms
(p = 0.257).
children with acute The proportion
watery diarrhea of caretakers who sought
treatment elsewhere prior to
coming to the study HCs were not
Received treatment significantly different
(p = 0.247).
Adheren
Adheren
ce
ce to
to
The caretakers were asked to quantify how
many of the10 zinc tablets prescribed were
actually given to their child.
zinc
zinc 37,9 Status Quo
% received the full ten days treatment course.
supplem
supplem 45,7 Bundling without Message

entation
entation
% received the full ten days treatment course.
64,6 HC Level Bundling
% received the full ten days treatment course.
65,9 Central Bundling
% received the full ten days treatment course.i
 ANO The average (± SD) of total zinc tablet report that gave are 7.70 (±
2.90)
VA Central Bundling

TEST Bundling without Message

HC Level Bundling

Status Quo
Mean±
SD

Adherence level to zinc supplementation

p <0.001

There is not signicant different HC Level Bundling Bundling without Message There is not signicant different
between both of them Central Bundling Status Quo between both of them
p = 0.557 p = 0.999
 Multivariate adjustments were madefor two potential confounders:
1. number of episodes ofdiarrhea

linear 2. extent of dehydration during the first presentation)

regression
Bundling without Message
VS Central Bundling
With increased level of adherence
Status Quo VS Central Bundling
With increased level of adherence of:
of:

No difference was
Bundling without observed between the
Status Quo VS HC Level ‘status quo’ and
Message VS HC
‘bundling without
Level Bundling Bundling message’ arms (p =
With increased level of With increased level of adherence of: 0.319); and between
adherence of: ‘central bundling’ and
‘HC level bundling’
arms
(p = 0.894) (Table 3).
ADHERENCE TO ORS
ADHERENCE TO JOINT ZINC-ORS
TREATMENT
Co-packing
As compared with the
‘HC level’ ‘status quo’ arm
(86.5%) As compared with

‘central’ ‘HC level’ the

‘bundling without
(86.4 15.7 12.0 message
%)
03
‘central’
03 14.8 12.6
REASONS FOR NOT ADHERING TO
ZINC-ORS TREATMENT
• recovery of the child (42.3%)
300 • the child did not like it (25.3%)
caregivers • forgetfulness (21.7 %)
who missed 2 • occurrence of perceived side effects
or more ZINC (13.0 %)

• The child did not like it (52.6%)

190 • Thinking that ORS does not help
respondents the child much (20.0%),
• Forgetfulness 03
(12.6 %)
Failed to • Underestimating the seriousness of
give ORS the disease (10.5 %)
• Giving preference
03 to homemade
fluids (7.9 %).
ESTIMATED UNIT AND TOTAL NATIONAL
COST FOR DIARRHEA TREATMENT

(USD 0.658/episode)

central
bundling HC level
bundling
(USD 0.608/episode)
03

03
INCREMENTAL CE OF THE CENTRAL
AND HC LEVEL APPROACHES

Central
bundling

HC level
bundling 03

03
CONT..

03

03
.

DISCUSSION
DISCUSSION
Co-packaging of zinc with ORS can enhance
adherence to treatment

In this study the level of zinc, ORS and joint

adherences were comparable in the central and HC
level bundling arms
The most frequent reason for discontinuation of zinc is
recovery of the child and lack of caregiver awareness
of benefit of zinc
DISCUSSION
Benefit • prevention of diarrhea
zinc

• promotional material, strong

communication on the need to complete
important the dosage regardless of whether the
to include child’s diarrhea has ceased
DISCUSSION
Limitation of this study

The data were only from the HCs

Any contribution of the intervention in terms of

reducing the severity and recurrents of diarrhea
has not been considered
.

CONCLUSION
CONCLUSION
 Bundling zinc with ORS via a pouch
with instructional messages
increases adherence to diarrhea
treatment.
 ‘HC level bundling’ is more cost
effective than the ‘central bundling’
strategy.
 Bundling is a feasible approach for
enhancing adherence to diarrhea
treatment.
THANK YOU