Low 2006b.
Methods |
Setting: 27 general practices in Bristol and Birmingham, UK Enrolment: participants enrolled from March 2001 to October 2002 Follow‐up: 6 weeks after randomisation there was telephone follow‐up of index patient |
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Participants | 140 index patients (92 woman and 48 men) with Chlamydia trachomatis were randomised Inclusion criteria
Exclusion criteria
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Interventions | All participants received antibiotic treatment before randomisation Simple patient referral with counselling from practice nurse (n = 72) Nurses received 1 day of training about sexual history taking, management of chlamydia and PN. The index patient had a PN interview with the trained nurse. This interview involved taking of sexual history of the previous 6 months, patient referral using contact slips, abstinence and information about being screened for other STIs. Contact slips included details of the study GUM clinics and requested the treatment centre to return the slip to the study centre. Practise nurses did not follow‐up the index patient Referral to GUM clinic for partner referral from specialist health advisor (n = 68) At randomisation, index patients were referred to GUM clinic. If clinic had not been contacted by telephone within 1 week by index patient, the health adviser made 2 attempts to contact them. PN was performed according to standardised protocols and contact slips were issued. The index patient was also offered a consultation for screening for other STIs. Follow‐up was by telephone |
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Outcomes |
Primary outcome
Secondary outcomes
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Notes | Ethical approval South West multicentre research ethics committee Only 72 in nurse arm and 47 in clinic arm Study author was contacted to clarify clustering and replied. The author replied that the trial was individually randomised. However, there was often more than 1 participant from a single general practice (i.e. clustering), and it means that there are likely to be similarities between patients within the same practice |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated random numbers, permuted blocks, stratified by practice |
Allocation concealment (selection bias) | Low risk | Central computerised telephone system |
Incomplete outcome data (attrition bias) All outcomes | Low risk | The PR (nurse) group had PN interview on same day. In PR (GUM) 21/68 (31%) did not attend PN interview. Authors used ITT analysis and assumed those lost to follow‐up were not treated |
Selective reporting (reporting bias) | Unclear risk | Protocol available from trial registries. In protocol, adherence to advice to abstain from sexual intercourse until both partners completed treatment was stated as a secondary outcome but not reported in trial. Outcome "Cases with all partners treated" was not prespecified in study protocol but reported |
Other bias | Low risk | No other bias identified |
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 | A researcher not involved in the participant's PN did the follow‐up |