Advanced Search

Study Preview



Study Title and Description

Health education and antibiotic therapy in trachoma control



Key Questions Addressed
1 What is the effect of environmental sanitary interventions for preventing active trachoma?
  • Comments Comments (
    0
    ) |

Primary Publication Information
  • Comments Comments (
    0
    ) |
TitleData
Title Health education and antibiotic therapy in trachoma control
Author * Resnikoff S, Peyramaure F, Bagayogo CO, Hugnet P
Country
Year 1995
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 Health education Health education was given by repeated information on personal, family hygiene and trachoma, at a frequency of one week per month.
  • Comments Comments (
    0
    ) |
2 No intervention
  • Comments Comments (
    0
    ) |

Design Details
Question... Follow Up Answer Follow-up Answer
Page 89-98
  • Comments Comments (
    0
    ) |
Methods Paper reports "Randomisation" (How randomisation was done could not be ascertained)Assessor not masked
  • Comments Comments (
    0
    ) |
Interventions 1) Health education (424) versus none (476) for 6 monthsHealth education was given by repeated information on personal, family hygiene and trachoma, at a frequency of one week per month
  • Comments Comments (
    0
    ) |
Outcomes Incidence of active trachomaIncidence was determined by expressing the cumulative number of new cases of active trachoma over the follow up period of 6 months
  • Comments Comments (
    0
    ) |
Notes The study had 4 arms, but we only used 2 armsi.e. Health education versus no interventionAge and sex distribution in the 2 villages were identicalThe baseline prevalence of active trachoma in the 2 villages was not significantly different (21% versus 19% )The follow up period in all the villages was identical - 6 months
  • Comments Comments (
    0
    ) |
Participants 1810 people of all ages in 4 villages of Mali
  • Comments Comments (
    0
    ) |
Recruitment bias:Authors' judgement Unclear risk
  • Comments Comments (
    0
    ) |
Recruitment bias:Support for judgement "With the permission of administrative and traditional authorities, all inhabitants of these four villages were surveyed". Patients and methods, page 102 There was no discussion of recruitment bias in the paper and little information on response rates. It was unclear whether the community-level intervention here - provision of health education (based on community participation) and antibiotic distribution - would have affected recruitment to the study assessments
  • Comments Comments (
    0
    ) |
Baseline imbalance:Authors' judgement Unclear risk
  • Comments Comments (
    0
    ) |
Baseline imbalance:Support for judgement Although there was some evidence to suggest that the villages were similar (see quotes and data below) only 4 villages were randomised so other differences in other important confounders cannot be excluded "Four villages, matched for size and epidemiological, economic and social conditions, were included in the study. All villages were situated the same distance from the health centre and each village possessed a school and was equipped with boreholes." Patients and methods, page 102 "The age and sex distribution was identical in all four villages" Results, page 103 Table 2 (page 109) shows the sex distribution (46% male in treatment community and 51% male in control community). No data on age distribution Baseline prevalence of active trachoma (figure 1, page 109) just over 20% in treatment community and just under 20% in control community
  • Comments Comments (
    0
    ) |
Blinding of participants and personnel (performance bias)Active trachoma:Authors' judgement High risk
  • Comments Comments (
    0
    ) |
Blinding of participants and personnel (performance bias)Active trachoma:Support for judgement For community based interventions such as health education it was not feasible to mask participants and personnel
  • Comments Comments (
    0
    ) |
Blinding of participants and personnel (performance bias)Other outcomes:Authors' judgement High risk
  • Comments Comments (
    0
    ) |
Blinding of participants and personnel (performance bias)Other outcomes:Support for judgement For community based interventions such as health education it was not feasible to mask participants and personnel
  • Comments Comments (
    0
    ) |
Blinding of outcome assessment (detection bias)Active trachoma:Authors' judgement High risk
  • Comments Comments (
    0
    ) |
Blinding of outcome assessment (detection bias)Active trachoma:Support for judgement For community based interventions such as health education it would have been difficult to mask outcome assessors and this was not mentioned in the report
  • Comments Comments (
    0
    ) |
Blinding of outcome assessment (detection bias)Other outcomes:Authors' judgement High risk
  • Comments Comments (
    0
    ) |
Blinding of outcome assessment (detection bias)Other outcomes:Support for judgement For community based interventions such as health education it would have been difficult to mask outcome assessors and this was not mentioned in the report
  • Comments Comments (
    0
    ) |
Incomplete outcome data (attrition bias):Authors' judgement Unclear risk
  • Comments Comments (
    0
    ) |
Incomplete outcome data (attrition bias):Support for judgement "At the initial examination, 1810 subjects were enrolled and examined" Results, page 104. Of these, 424 were from the community treated with topical antibiotics (village 2) and 476 were from the control community (village 4) (table 2 page 109) "A total of 347 subjects with active trachoma were included in the clinical trial. Two hundred and sixty five (76%) of these subjects were successfully followed for 6 months and were included in the analysis of the results." Results, page 105) However, the distribution of these cases by village is not reported. Using figure 1 (page 109) we can estimate that there were 89 cases of active trachoma in treatment community and 90 cases in control community. The "cure rate" in treatment village was 82% (estimated 73 people cured) and 36% in control community (estimated 33 people cured) No information was given on possible reasons for loss to follow up
  • Comments Comments (
    0
    ) |
Selective reporting (reporting bias):Authors' judgement Low risk
  • Comments Comments (
    0
    ) |
Selective reporting (reporting bias):Support for judgement Only clinical outcomes reported but no indication that microbiological data collected
  • Comments Comments (
    0
    ) |
Study design Cluster randomized trial (unspecified randomization method)
  • Comments Comments (
    0
    ) |
Unit of analysis Individual
  • Comments Comments (
    0
    ) |
Number randomly assigned Villages: 4; Individual: 1810
  • Comments Comments (
    0
    ) |
Losses to follow-up 24% of 347 subjects with active trachoma were lost
  • Comments Comments (
    0
    ) |
Number analyzed Health education: 424; No health education: 476; Subjects with active trachoma: 265
  • Comments Comments (
    0
    ) |
Country Mali
  • Comments Comments (
    0
    ) |
Age of participants All ages
  • Comments Comments (
    0
    ) |
Equivalence of baseline characteristics Age and sex distribution in the villages was identical, the baseline prevalence of trachoma in the two villages was not significantly different
  • Comments Comments (
    0
    ) |
Intervention 1 Health education: given by repeated information on personal, family hygiene, and trachoma, at a frequency of one week per month
  • Comments Comments (
    0
    ) |
Intervention 2 No health education
  • Comments Comments (
    0
    ) |
Length of follow up 6 months
  • Comments Comments (
    0
    ) |
Primary outcome, as defined in study report Incidence of active trachoma
  • Comments Comments (
    0
    ) |
Secondary outcome(s), as defined in study report
  • Comments Comments (
    0
    ) |
Times at which outcome(s) are assessed Not reported
  • Comments Comments (
    0
    ) |
Intervention 3
  • Comments Comments (
    0
    ) |




Results & Comparisons


Results Data
Odds Ratio (OR) 95% CI low 95% CI high
Outcome: Number of participants with TF or TI      Population: All Participants Between-Arm Comparisons
Time Point Measure Health education No intervention Comparison Measure No intervention vs. Health education


6 months

N Analyzed 424 476 2.4
Counts 4.2% 7.1% 1.1
5.1

Adverse Events
Arm or Total Title Description Comments