Ostergaard 2003.
Methods |
Setting: 4 counties in Denmark Enrolment: participants enrolled between February 1999 to March 2000 Follow up: no follow‐up of index patient reported |
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Participants | 562 index patients ( 414 women and 148 men) with a positive chlamydia swab were randomised Inclusion criteria
Exclusion criteria
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Interventions | Specimen collection package was posted to the index patient's home address. There were 5 specimen collection kits in this package. The index patient was instructed to give collection kits to his/her sexual partners of the previous 12 months. The collection kits were identical. For male partners the kit contained 10 mL tube to collect first void urine sample. The female partners received a vaginal pipette containing 5 mL sterile normal saline to be inserted into the vagina, flushed and aspirated Patient referral with home sampling (n = 304) Samples collected by the partners at home had to be posted directly to the diagnostic laboratory in postage paid and pre‐addressed envelopes Patient referral with office sampling (n = 258) Partners had to bring specimen collection kit into the office of a healthcare provider to obtain sample. Partners also brought a letter with them, explaining the study and the importance that the healthcare provider used the provided specimen collection kit to collect sample. The healthcare provider posted the sample to the laboratory |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | Ethical approval by Danish ethics committee system Implied consent |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | The index patient was randomised based on a positive swab sample ‐ no details given |
Allocation concealment (selection bias) | Unclear risk | No details on allocation concealment given |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome data for all partners of index patients available |
Selective reporting (reporting bias) | Low risk | Outcomes in method same as in results. Protocol not available from 3 trial registries |
Other bias | Low risk | No other bias identified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Specimen collection kits for the 2 study groups were identical and the index patient was blinded to content of the specimen collection kit. However there is no guarantee that the index patient did not open the package before forwarding to partner The healthcare provider, who did the office sampling, was not part of the study. They only collected the samples and posted it to the study centre |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | It is not mentioned whether laboratory personnel were blinded. However, the chlamydia test is an objective outcome measure |