Schillinger 2003.
Methods |
Setting: FPCs (Southern California (SC), Seattle (S) and New Orleans (NO)), adolescent clinics (Birmingham (B), Indianapolis (I), Northern California (NC) and S), primary care clinics (I) and STD clinics (B, I, NO, SC, NC, S) or emergency and other hospital departments (B), US Enrolment: participants enrolled between September 1996 and June 2000 Follow‐up: index patients returned for a follow‐up at 1 and 3 months after enrolment for an interview and urine test |
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Participants | 1889 index patients with laboratory confirmed Chlamydia trachomatis were randomised Inclusion criteria
Exclusion criteria
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Interventions | At enrolment all women were treated for chlamydia infection and were advised to abstain from intercourse until 7 days after partner's treatment Simple patient referral (n = 943) Index patients were instructed to tell their partners that they had been exposed to chlamydial infection and to recommend that they seek treatment. They were given an information sheet for each partner and list of clinics where the partner could obtain free care EPT (n = 946) Index patients were provided with up to 4 doses of medication for their partners, instructed to tell their partners of their exposure, and to give a package with the medication, instructions, warnings, fact sheet on chlamydia and telephone number to contact if partners had any questions. Index patients were advised to abstain from intercourse until 7 days after each partner's treatment |
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Outcomes |
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Notes | Ethical approval by investigational review boards at each of participating institutions and the CDC Limited power as only 1454 participants completed study to 1 follow‐up. With 0.05 significance, this study only had 62% power to detect a 30% reduction in infection. For a 20% difference in infection rate (as was observed in this study), there was only 37% power to detect a significant difference between 2 interventions. In order to have 80% power, need 2035 women in each arm |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Study allocations were made with use of "randomly sized blocks" |
Allocation concealment (selection bias) | Low risk | Study arm assignments were printed on cards and placed in sequentially numbered, opaque envelopes and sealed at the study co‐ordination centre |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 1454/1787 (81%) participants came for at least 1 follow‐up visit and gave a urine sample for the outcome measure. There was a similar proportion in each study arm. ITT was not followed because index patients who did not return for follow‐up or for whom no urine test result existed were excluded |
Selective reporting (reporting bias) | Low risk | Outcomes reported in methods section were reported in results section. Protocol not available from 3 trial registries |
Other bias | Low risk | No other bias identified |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Blinding was not possible |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | 1 month after treatment, women were interviewed again and urine tested with LCx/PCR. Assessor knew assignment but outcome measure was objective |