Cameron 2009.
Methods |
Setting: city centre FPC, GUM or a hospital termination of pregnancy in Edinburgh, UK Enrolment: participants enrolled from May 2004 to December 2006 Follow‐up: index patients agreed to submit a urine sample at 3‐monthly intervals over 12 months |
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Participants | 330 index patients who tested positive for Chlamydia trachomatis were randomised in Edinburgh Inclusion criteria
Exclusion criteria
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Interventions | All index patients received written and verbal information about chlamydia and the importance of partner treatment Simple patient referral (n = 110) Index patients provided details of partners of past 6 months. Index patients contacted partners themselves and were given standard contact slips to be given to partners. Index patients also received information leaflet about chlamydia with details of GUMs. After 4 weeks, index patient was contacted by study personnel to check if partners were successfully contacted Patient referral with postal testing urine kit (n = 110) Index patient provided details of partners of past 6 months. Index patient received 1 postal testing kit to deliver to each partner to collect a urine sample in. Postal testing kit consisted of a universal container for the urine sample, laboratory form with preferred contact method, an instruction leaflet and a postage paid pre‐addressed envelope to send sample to laboratory. The kit also included a leaflet about chlamydia, information about the study and contact details of study nurse if further information required. EPT (n = 110) Index patient provided details of partners of past 6 months. Index patient was given 1 treatment pack to give to each partner. The treatment pack contained azithromycin 1 g, an information leaflet about the study with contact details for study nurse, information about chlamydia, drug safety leaflet and details of GUMs they could attend for testing/treatment if they preferred. The study information leaflet contained a 'tear‐off' slip that the partner was asked to complete and return (in a pre‐addressed postage paid envelope) to confirm that they had taken the medication. There was also an 'objection' slip that could be completed and returned, if the partner objected to treatment in this way |
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Outcomes |
Primary outcome Re‐infection in index patient (all index patients received a postal testing kit for themselves, and were asked to post a urine sample to laboratory for re‐testing at 3 months' post‐treatment, further postal testing kits were sent to index patient at 6, 9 and 12 months for repeat testing) Secondary outcomes Partner testing/treatment rates (laboratory and clinic databases were checked) |
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Notes | Ethical approval obtained from the Lothian Research Ethics Committee. Approval was also obtained from both the Research and Developmental Department and the Chief Pharmacist of the Responsible Health Care Trust | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation numbers in blocks, stratified for each recruitment site |
Allocation concealment (selection bias) | Unclear risk | Sealed opaque envelopes, not clear if sequentially numbered |
Incomplete outcome data (attrition bias) All outcomes | High risk | Primary outcome: 215/303 participants submitted at least 1 urine sample in the 12‐month follow‐up (70%) period ‐ 13 woman informed the study personnel that they did not want to take part anymore (reasons not given), other 75 loss to follow‐up no details given. No details given on ITT For secondary outcomes the partners of every index patient who was randomised had an outcome |
Selective reporting (reporting bias) | Low risk | Outcomes reported in methods section were reported in results section. Protocol not available in 3 trial registries |
Other bias | Low risk | No other bias detected |
Blinding of participants and personnel (performance bias) All outcomes | High risk | There was no blinding |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | The research nurse and doctor were not blinded. They were involved in the baseline interview and did the 6‐month follow‐up call to record whether partners were notified ‐ to validate treatment and testing rates the laboratory, FPC and GUM clinic databases were checked Primary outcome assessment was blinded. The postal testing kit samples of the participating woman were labelled with non‐identifying subject study codes so the laboratory staff who reported the results did not know to which intervention the woman belonged The COBAS Amplicor CT test was used on urine samples Partner treatment/test rates: outcome assessment not blinded but validated by records |