Golden 2005.
Methods |
Setting: participants were interviewed at the Public Health‐Seattle and King County (PHSKC) STI clinic and one other PHSKC clinic in King County, Washington, US Enrolment: patients who received a diagnosis of gonorrhoea or genital chlamydial infection between 29 September 1998 and 7 March 2003 were identified through laboratory reporting, case reports from healthcare providers and onsite case ascertainment were identified. Clinicians who made diagnosis were contacted to seek permission and potential participants were contacted for an interview Follow‐up: interview of index patient 10‐18 weeks after treatment |
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Participants | 2751 index patients, 646 men and 2105 women, with either gonorrhoea or chlamydia or both infections were randomised Inclusion criteria
Exclusion criteria
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Interventions | Before randomisation, study personnel offered to contact partners who index patients were unable or unwilling to contact themselves Simple patient referral (n = 1376) Index patients were advised to tell their partners to seek care and that care was available at no cost at the STI clinic EPT (n = 1375) Index patients were offered medication to give to up to 3 partners, study staff members offered medication to partners they contacted themselves. Partner packages were distributed to patients or their partners through commercial pharmacies, the PHSKC STI Clinic or direct mailing. Packets also contained condoms, information on medication, warning for adverse effects, telephone contact for study staff and brochure. Pharmacies were contacted 1 week after medication prescribed to determine whether it was picked up ‐ if not picked up within 1 week patient received a telephone call reminder |
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Outcomes |
Primary outcome
Secondary outcome
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Notes | Ethical approval obtained from the institutional review board of the University of Washington and Group Health Cooperative | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | At enrolment, 2751 patients reported having untreated partners they could contact and underwent randomisation. No details given |
Allocation concealment (selection bias) | Unclear risk | No details given |
Incomplete outcome data (attrition bias) All outcomes | High risk | Of 1375 assigned to the expedited treatment arm, 929 (68%) completed study. Of 1376 assigned to partner referral arm, 931 (68%) completed study. Only participants completing the study were included in the analysis |
Selective reporting (reporting bias) | Unclear risk | Persistent or recurrent gonorrhoea or chlamydia were the primary outcome stated in the methods section. Behavioural outcomes were reported in the outcome section. Adverse events were not reported and unclear whether no adverse events were reported or whether authors failed to record them. Protocol was not available from 3 trial registries |
Other bias | Unclear risk | Selective reporting of subgroups, this might have been a potential bias but there is insufficient information to assess whether an important risk of bias exist |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participant and personnel not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | No blinding. Urine test use LCx (Abbott) ligase chain reaction used for primary outcome ‐ objective. Self report on behavioural outcome ‐ subjective |