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. 2015 Sep 29;2015(9):CD011317. doi: 10.1002/14651858.CD011317.pub2

Ostergaard 1998.

Methods Setting: High schools in Aarhus, Denmark
 Study design: Cluster randomized trial, parallel two arms. Enrollment between January 1997 and April 1997
Sample size estimation a priori: No
Participants Inclusion criteria
  • Male and female students who returned the questionnaire and were sexually experienced


Exclusion criteria
  • Not specified


Population
Mean age females 18 years, males 18.2 years.
8909 students were randomized, 4336 to home‐based strategy (2603 women and 1733 men) and 4573 to clinic‐based strategy (2884 women and 1689 men) for CT detection. To deal with unit analysis issues about cluster‐randomized studies we used an ICC 0,00119, average cluster size of 524; hence the effective sample size for home group was 2673 and 2819 for clinic group.
Interventions Home‐based specimen collection (n = 2673)
 In the home group the students completed a questionnaire and received information regarding CT infection; female students were asked to collect two urine samples and one vaginal flush sample, males were asked to collect one first void urine sample and mail from home to the laboratory.
 Clinical‐based specimen collection (n = 2819)
 In the clinic group the students completed a questionnaire and received information regarding CT infection; they were offered a free test from their doctor or at the local clinic.
Outcomes
  • Number of students tested (799/2673)(41/2819)

  • Number of students infected (33/799)(4/41)

Notes Funding sources: "The study was funded by the Danish National Board of Health, Løvens Kemiske Fabriks Research Foundation, Nycomed DAK, Pfizer, and Chairman Jacob Madsen and Hustru Olga Madsen's foundation"
Role of funder: Not reported
Declarations of interest: None declared
It is unclear if all participants with positive test and their sexual partners were treated. Ethical approval was obtained from ethics committee and the Danish Data Protection Agency. Unclear whether consent was obtained
Number of identifier register: Not found
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Quote "We randomised all 17 high schools": details about the process of sequence generation for cluster‐randomization not reported
Allocation concealment (selection bias) Unclear risk No details on allocation concealment given in the report.
Blinding of participants and personnel (performance bias) 
 All outcomes High risk No blinding, the outcomes are likely to be influenced by lack of blinding.
Blinding of outcome assessment (detection bias) 
 Subjective outcomes Unclear risk No subjective outcomes reported.
Blinding of outcome assessment (detection bias) 
 Objective outcomes Unclear risk It is not reported if the laboratory personnel or assessors were blinded.
Incomplete outcome data (attrition bias) 
 Short‐term outcomes High risk After we used the effective sample size for this cluster‐randomized study, the attrition rate was 799/2673 for home‐based group; and for clinic‐based group it was 41/2819. More than 20% participants were not tested and the missing data were not balanced in the groups.
Incomplete outcome data (attrition bias) 
 Long‐term outcomes Unclear risk Only number of individuals not tested reported; however clearly information was not available to make a judgement.
Selective reporting (reporting bias) Unclear risk Protocol was not available from 3 trial registries. No information available in methods section to make a judgement.
Other bias Unclear risk No other bias identified.