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Study Title and Description

Northern Territory Trachoma Control and Eye Health Committee's Randomised Controlled Trial of the Effect of Eye Drops and Eye Washing on Follicular Trachoma Among Aboriginal Children



Key Questions Addressed
1 What is the effect of face washing promotion for preventing active trachoma?
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Primary Publication Information
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TitleData
Title Northern Territory Trachoma Control and Eye Health Committee's Randomised Controlled Trial of the Effect of Eye Drops and Eye Washing on Follicular Trachoma Among Aboriginal Children
Author Peach H, Piper S, Devanesen D, Dixon B, Jefferies C, Braun P, et al
Country
Year 1987
Numbers

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


Extraction Form: Face washing promotion for preventing active trachoma 2015
Arms
Number Title Description Comments
1 Oily tetracycline eye drops oily tetracycline eye drops daily for one week every month
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2 Daily eye washing daily (every school day) eye washing
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3 Oily tetracycline eye drops + Eye washing oily tetracycline eye drops daily (every school day) for one week every month plus daily (every school day) eye washing
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4 No intervention
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 1-33
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Study design cluster-RCT
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Number randomized 36 communities (1143 children)
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Exclusions after randomization none reported
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Unit of analysis individual children
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Number analyzed 1143 children total; 374 in eye drops group; 246 in eye washing group; 312 in combined group; 211 in non-treatment group
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Losses to follow-up 128 (11.2%) children total; 34 in eye drops group; 44 in eye washing group; 28 in combined group; 22 in non-treatment group
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How was missing data handled? "Children which the trachoma workers could not follow-up were assumed to have follicular trachoma and were included in the analysis."
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Reported power calculation sample size of 1500; power 80%
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Unusual study design "For each trachoma worker communities were allocated to all four groups and the allocation was done in stages…"
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Country Northern Territory of Australia
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Age 5 to 14 years; also included school children older than 14 years and pre-school children (ages not specified)
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Gender boys and girls
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Inclusion criteria for community Aboriginal communities in the Northern Territory; population of about 100 or more
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Inclusion criteria for children Aboriginal children with follicular trachoma
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Exclusion criteria for community communities where &";the yield of trachoma cases was expected to be small (less than or equal to6)"
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Equivalence of baseline characteristics no; "… more children aged 10 years old and above in the control group than in the other treatment groups …"
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Intervention 1 oily tetracycline eye drops daily for one week every month
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Intervention 2 daily (every school day) eye washing
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Intervention 3 oily tetracycline eye drops daily (every school day) for one week every month plus daily (every school day) eye washing
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Intervention 4 no treatment
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Length of follow-up Planned: 3 months; Actual: mean days of follow-up by intervention: 83.7 days for eye drops group, 85.6 days for eye washing group, 79.5 days for combined group, and 85.2 days for control group
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Primary outcome, as defined in trial reports follicular trachoma status (present or absent)
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Secondary outcomes, as defined in trial reports none
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Adverse events not reported
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Intervals at which outcomes assessed baseline and 3 months
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Type of study published
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Funding sources "The study was funded entirely by the Northern Territory Trachoma and Eye Health Committee Inc."
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Disclosures of interest not reported
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Study period not reported
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Reported subgroup analyses yes (trachoma worker, geographical zone); "None of the differences between the trachoma workers in the results they obtained for any of the treatment programmes was statistically significant"; "The reduction in the number of children with follicular trachoma after the combined programme was significantly greater in communities in zones 2 and 8 than in zone 1."
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Trial investigators contacted? yes; trial investigator contacted and provided information for previous versions of this review
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Pair 1
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Pair 2
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Pair 3
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Total
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Inclusion criteria
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Exclusion criteria
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Outcomes, as defined in trial reports
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Random sequence generation (selection bias):Authors' judgement Low risk
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Random sequence generation (selection bias):Support for judgement A random number table was used to allocate communities to one of four treatment groups.
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Allocation concealment (selection bias):Authors' judgement Unclear risk
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Allocation concealment (selection bias):Support for judgement Allocation concealment not reported.
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Masking outcome assessors:Authors' judgement Low risk
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Masking outcome assessors:Support for judgement "Trachoma workers did not know what treatment programme, if any, had been allocated to a particular community." "For each trachoma worker communities were allocated to all four groups and the allocation was done in stages to control for observer variation and a possible learning effect by the trachoma workers".
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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 128 (11.2%) children total (34 in eye drops group, 44 in eye washing group, 28 in combined group, 22 in non-treatment group) lost to follow-up; "The children whom the trachoma workers were unable to follow-up were assumed to have follicular trachoma and were included in the analysis… The data were re-analyzed after having excluded the missing cases and the overall results were similar"; "Level of missingness differed by treatment group – eye washing group had the highest % of missing cases".
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Selective reporting (reporting bias):Authors' judgement Unclear risk
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Selective reporting (reporting bias):Support for judgement No protocol available.
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Other bias:Authors' judgement Unclear risk
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Other bias:Support for judgement This was a cluster-RCT; however, data were analyzed at the individual participant level without accounting for the cluster design; sensitivity and specificity of aboriginal trachoma workers in diagnosing follicular trachoma varied.
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Results & Comparisons


Results Data
Outcome: Number of participants with active trachoma      Population: All Participants Between-Arm Comparisons
Time Point Measure Oily tetracycline eye drops Daily eye washing Oily tetracycline eye drops + Eye washing No intervention Comparison Measure Daily eye washing vs. No intervention Oily tetracycline eye drops + Eye washing vs. Oily tetracycline eye drops


3 months

N Analyzed 374 246 312 211 Relative Risk 1.03 1.02
Mean 250 191 215 160 95% CI low 0.93 0.93
SD 95% CI high 1.14 1.13
SE

Adverse Events
Arm or Total Title Description Comments