Apoola 2009.
Methods |
Setting: STI clinic at a single study site in Derbyshire, UK Enrolment: participants recruited by health adviser ‐ recruitment period not given Follow‐up: no follow‐up of index patient |
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Participants | 200 index patients with a diagnosis of genital chlamydia were randomised Inclusion criteria
Exclusion criteria
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Interventions |
Patient referral with swab testing (clinic) (n = 100) Index patients were seen by a health adviser and details of contacts recorded. Contact slips coded with the diagnosis were given to the index patient to give to the male partners, who were to bring this to the clinic for testing by urethral swab and treatment Patient referral with home sampling urine kit (n = 100) Index patients were seen by health advisers and details of contacts recorded. Contact slips coded with the diagnosis and a urine sampling kit, for the partner, with instructions, on collecting a first pass urine sample at home, were given to the index patient. Sampling kits included directions to clinic where the samples would be tested and partners would be treated if they tested positive |
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Outcomes |
Primary outcome:
Secondary outcomes:
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Notes | Ethical approval was obtained from the Derbyshire Research Ethics Committee When the study was originally designed, the PN rate at the study site was 0.3 contacts per index case of chlamydia and the study was powered to detect a difference of 0.2 contacts per index case. However, during the study period, the PN rates improved significantly making it more difficult to detect 0.2 contacts per case difference Authors were contacted regarding blinding, consent and exact numbers reported. Authors reported that investigators were not blinded, oral consent was obtained and they gave the number of partners elicited |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Blocked randomisation based on random numbers |
Allocation concealment (selection bias) | Low risk | Allocated group concealed in sealed opaque numbered envelopes opened sequentially |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Outcome for each partner of every index patient who was randomised was available |
Selective reporting (reporting bias) | Low risk | Protocol was available from trial registry. Only primary outcome was stated in protocol, no secondary outcomes were stated. Primary outcome in protocol same as in trial. Outcomes in method section of trial are the same outcomes reported |
Other bias | Low risk | No other bias identified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants or personnel (health adviser) |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Investigators were not blinded. Nucleic acid amplification tests with high specificity and sensitivity were used on urine specimens. Test used for urethral swab not specified. Details on blinding not given but obtained from authors directly who advised that investigators were not blinded |