Tomnay 2006.
Methods |
Setting: a publicly funded sexual health clinic in Melbourne, Vic, Australia Enrolment: participants were enrolled between July 2003 and July 2004 Follow‐up: 1 week after attending the clinic all index patients were contacted via telephone and interviewed by an experienced "contact tracer" |
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Participants | 105 index patients with chlamydia or NGU (76 men and 29 women) were randomised Inclusion criteria
Exclusion criteria
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Interventions |
Simple patient referral (n = 32) Each index patient received a sealed envelope. In each envelope there were 5 standard partner letters used for contact tracing. Each index patient was asked to pass a letter to each partner Patient referral with website (n = 73) Each index patient received a sealed envelope. In each envelope there were 5 standard letters used for contact tracing with addition of a uniform resource locator address to a disease‐specific website. Each index patient was asked to pass a letter to each partner. The sites provided information for the partners about the infection to which they had been exposed. A printable letter for the partner to take to their own doctor and an anonymous questionnaire were available on the website. Contact details of the researchers and ethics committee were available to report any complaints |
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Outcomes |
Primary outcome
Secondary outcome
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Notes | Ethical approval by the Department of Human Services, Victoria and the University of Melbourne | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Statistical package for Social Sciences (SPSS Inc., Chicago, USA) to generate random numbers between 1 and 27. Block randomisation was used (blocks of 27), with 18 randomised to the website and 9 to the standard letter. This was performed so that each clinic room had 1 randomised block |
Allocation concealment (selection bias) | Low risk | The envelopes with the website or standard pack were identical. Thickened opaque paper and were thoroughly sealed. No opened or missing envelopes were identified during the study |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 97/105 (92%) index patients completed study up to telephone interview. Only 48/105 (46%) index patients returned to the clinic to evaluate re‐infection |
Selective reporting (reporting bias) | Low risk | Same outcomes reported that is stated in methods. No protocol available from 3 trial registries |
Other bias | Low risk | No other risk of 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 | Unclear risk | No blinding Contact tracer: not clear if contact tracer was blinded. Participants were contacted via telephone 1 week after attending the clinic and were interviewed by an experienced contact tracer regarding the number of partners contacted, the method used whether the letter had been passed on and the reaction of the partner(s) to the method used. A questionnaire was used but no details given on whether this was a structured questionnaire Study personnel: to assess re‐infection of index patient, the study personnel looked at medical files in the 2‐12 week period post‐treatment |