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Study Title and Description

How much is not enough



Key Questions Addressed
1 What is the effect of environmental sanitary interventions for preventing active trachoma?
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Primary Publication Information
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TitleData
Title How much is not enough
Author Abdou A, Munoz BE, Nassirou B, Kadri B, Moussa F, Baarè I, et al
Country
Year 2010
Numbers

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Environmental sanitary interventions for preventing active trachoma 2012
Arms
Number Title Description Comments
1 No intervention
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2 Heath education + improved water supply
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 98-104
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Methods Randomisation of 10 villages using simple random number tableOutcome assessors were partially maskedLosses to follow up was same for the both groups (11% versus 12%)Some of the baseline variables were not equal for both groups¬for example the intervention villages had significantly higher prevalence of Chlamydia trachomatis¬ infection rates (26% versus 14%), higher proportion of 3 to 4 year olds and higher proportion of children living in compounds where garbage is observed within
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Interventions 1. The intervention villages had a health education programme which was implemented 3 months prior to the 2 year survey. A dedicated health educator used flip charts and interactive discussions in one or two village meetings to highlight the importance of personal hygiene 2. Also all intervention villages had at least one hand pump well constructed (range of 1 to 3 wells) over the 2 year period
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Outcomes Prevalence of active trachoma, prevalence of Chlamydia trachomatis from conjunctival swab
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Notes Both group of villages had access to an ongoing radio programme on trachoma, also it was reported both village¬groups were not far from the source of water
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Participants 557 children: aged 1 to 5 years old in 10 villages in Niger republic
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Recruitment bias:Authors' judgement Low risk
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Recruitment bias:Support for judgement "Within villages, we aimed to randomly select 60 children ages 1 to 5 years as sentinel markers of infection and trachoma. The census data from the house-to house survey that we collected was the basis for selection of children. Stratified random sampling was applied to select no more than one child per mother to minimize clustering of children within households. Of 591 children selected, 557 were examined (94%) at baseline. The same sample of children was surveyed for infection one year (January 2007) and two years (January 2008) later." Methods, page 2 "At one year, we re-surveyed 91% of the original sample (91% in intervention and 91% in the control villages). At two years, we re-surveyed 89% of the original sample (89% in the intervention and 88% in the control villages). The primary reason for loss to follow-up at both times was death of the child or child having left the village." Results, page 4
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Baseline imbalance:Authors' judgement High risk
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Baseline imbalance:Support for judgement "The study populations in the two arms were mostly similar. The overall baseline prevalences of trachoma were similar in the intervention (43%) and control arms (40%, p=0.75). However, the prevalence of infection with C. trachomatis at baseline was 26% in the intervention villages and 14% in the control villages, significantly different (p=0.02) (Table 1). There was no difference by intervention arm in the proportion of female sentinel children, the number of children in the compound younger than 8 years, time to walk and wait to get water, or the size of the village (Table 1). However, there was imbalance in the ages of the sentinel children, with more 1–2 year-olds in the control villages, and more 3–4 year-olds in the intervention villages. The children in the intervention villages were also more likely to live in a compound with waste inside, 70%, compared to children in the control villages, 51% (Table 1)." Results, page 4
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Blinding of participants and personnel (performance bias)Active trachoma:Authors' judgement High risk
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Blinding of participants and personnel (performance bias)Active trachoma:Support for judgement For such community based interventions such as health education and provision of clean water supply it was not feasible to blind participants and personnel
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Blinding of participants and personnel (performance bias)Other outcomes:Authors' judgement High risk
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Blinding of participants and personnel (performance bias)Other outcomes:Support for judgement For community based interventions such as health education and provision of clean water supply it was not feasible to blind participants and personnel
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Blinding of outcome assessment (detection bias)Active trachoma:Authors' judgement Unclear risk
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Blinding of outcome assessment (detection bias)Active trachoma:Support for judgement "The trachoma grader was masked to the intervention status of the village they were working in, although we cannot exclude their hearing from village residents." Methods, page 3
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Blinding of outcome assessment (detection bias)Other outcomes:Authors' judgement Low risk
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Blinding of outcome assessment (detection bias)Other outcomes:Support for judgement Ocular C. trachomatis infection: "The laboratory personnel were masked to intervention and control status of the swabs received from the field." Methods, page 3
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Incomplete outcome data (attrition bias):Authors' judgement Low risk
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Incomplete outcome data (attrition bias):Support for judgement "Two villages were extreme outliers: one had a small population and a low trachoma rate of 3% of children aged 5 years and younger; the other had a very high rate of 82%. These villages were removed from the trial, one from each arm, as they led to extreme imbalance at the outset (Figure 1)." Methods, page 2 "At one year, we re-surveyed 91% of the original sample (91% in intervention and 91% in the control villages). At two years, we re-surveyed 89% of the original sample (89% in the intervention and 88% in the control villages). The primary reason for loss to follow-up at both times was death of the child or child having left the village." Results, page 4
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Selective reporting (reporting bias):Authors' judgement Low risk
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Selective reporting (reporting bias):Support for judgement The pre-specified outcomes were infection with C. trachomatis and active trachoma and these were reported
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Study design Cluster randomized trial (using simple random number table)
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Unit of analysis Village
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Number randomly assigned Villages: 10; Children: 557
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Losses to follow-up Losses to follow up was the same for both groups (11% versus 12%)
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Number analyzed 557 children
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Country Niger Republic
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Age of participants 1 to 5 years
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Equivalence of baseline characteristics Some of the baseline variables were not equal for both groups. For example, the intervention villages had significantly higher prevalence of Chlamydia trachomatis infection rates (26% versus 14%), higher proportion of 3 to 4 year olds, and higher proportion of children living in compounds where garbage is observed within
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Intervention 1 Intervention villages had a health education program which was implemented 3 months prior to the 2 year survey. A dedicated health educator used flip charts and interactive discussions in one or two village meetings to highlight the importance of personal hygiene. Intervention villages also had at least one hand pump well constructed (range of 1 to 3 wells) over the 2 year period.
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Intervention 2 No intervention
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Length of follow up 2 years
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Primary outcome, as defined in study report Prevalence of active trachoma
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Secondary outcome(s), as defined in study report Prevalence of Chlamydia trachomatis from conjunctival swab
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Times at which outcome(s) are assessed 1 year and 2 years
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Intervention 3
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Results & Comparisons


Results Data
Outcome: Number of participants with TF or TI      Population: All Participants
Time Point Measure No intervention Heath education + improved water supply


1 years

N Analyzed
Mean 34% 39%
SD
SE


2 years

N Analyzed
Mean 49% 54%
SD
SE
Outcome: Chlamydia trachomatis      Population: All Participants Between-Arm Comparisons
Time Point Measure No intervention Heath education + improved water supply Comparison Measure Heath education + improved water supply vs. No intervention


1 years

N Analyzed Mean Difference 11%
Mean 15% 26% P-Value 0.39
SD
SE


2 years

N Analyzed Mean Difference 4%
Mean 11% 15% P-Value 0.11
SD
SE

Adverse Events
Arm or Total Title Description Comments