Kissinger 2005.
Methods |
Setting: public STI clinic in New Orleans, US Enrolment: participants enrolled from December 2001 to March 2004 Follow‐up: index patients were asked to return 4 weeks after the initial clinic visit (with a window of 2‐8 weeks) for a follow‐up interview and a urine specimen |
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Participants | 977 index patients with diagnosis of urethritis were randomised Inclusion criteria
Exclusion criteria
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Interventions |
Simple patient referral (n = 285) Index patients were instructed to tell their partners that they needed to go to either the public STI clinic or the clinic of their choice for STI evaluation and treatment Patient referral booklet enhanced (n = 348) Index patients were given a wallet‐sized booklet that contained 4 tear‐out cards with information for the partner and treatment guidelines for professionals. If they had more than 4 partners they were given additional booklets EPT (n = 344) Index patients were given packages containing medication, written instructions about how to take medication, warning about adverse effects, 24‐h nurse's pager number to call if any enquiries and asked to give package to each of their partners |
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Outcomes |
Primary outcome
Secondary outcome
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Notes | Institutional review board approval was obtained from all participating institutions Authors were contacted for statistical analysis (sample size calculations, power) details and exact numbers, authors replied that sample size calculations were performed, but could not provide exact details |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomised by month in which they attended the clinic to 1 of 3 study arms. Randomisation of months was conducted using a blocked scheme of 3 to 6 units using Microsoft Excel software |
Allocation concealment (selection bias) | Unclear risk | No information given |
Incomplete outcome data (attrition bias) All outcomes | High risk | 770/977 (79%) participants returned for follow‐up interview but only 37.5% were retested. At follow‐up interview, index patients were asked outcome questions for each partner. Outcome of interest was the response to the question: "Did baseline partner tell you that he or she took the medicine?" |
Selective reporting (reporting bias) | Unclear risk | Same outcomes in the methods section (re‐infection index patient and partners treated) were reported in the results section. With additional sexual outcomes (unprotected sex before partner treatment, re‐initiated sex with baseline partner, unprotected sex with any partner) not stated in the methods 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 | Participant and personnel not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The 1‐month interview was performed either by computer‐assisted self interview or study staff The outcomes were assessed by an interview either computer‐assisted self interview (24.3%), telephonic (35.4%) or face‐to‐face (40.2%). The interviewer was not blinded. An in‐person interview has the potential for information bias. No details given whether laboratory personnel were blinded but outcome measure was objective |