Trent 2010.

Methods	Setting: 5 clinical sites in 2 institutions ‐ a large academic medical centre (John Hopkins School of Medicine) and a community hospital (Saint Agnes Hospital), Baltimore, MD, US The 5 sites of recruitment included the paediatrics and adult emergency department at both centres and the combined general paediatrics and adolescent medicine clinic in the large academic centre Enrolment: trained research assistants screened patients with mild‐to‐moderate PID regarding inclusion and exclusion criteria to determine eligibility ‐ from 14 February 2006 to 25 July 2008 Follow‐up: index patients returned for a 72‐hour follow‐up after treatment, and a 2‐week post‐treatment, face‐to‐face interview with DIS
Participants	162 index patients with mild‐to‐moderate PID, were approached about recruitment, 131 were enrolled, data gathered from 126 participants were successfully transferred at enrolment and could be randomised Inclusion criteria Permanent residents of the metropolitan area under study Mild‐to‐moderate PID who had an outpatient‐treatment disposition Aged 15 years and older Access to telephone for follow‐up Willing to be randomised and contacted for follow‐up Exclusion criteria Severe disease ‐ potential surgical emergencies, significant nausea, vomiting or high fever; evidence of tubo‐ovarian abscess; or other extenuating medical circumstances Pregnant Concurrent diagnosis of sexual assault Unable to communicate Previously enrolled and re‐diagnosed with PID Aged 14 years or younger
Interventions	Care of patients in both arms included detailed discharge instructions, a full 14‐day course of medication and a written hand‐out to facilitate self care Patient referral with video (n = 61) Index patient watched a 6‐minute video that tells the story of PID as related by a universal patient created by the voices and images of 7 different female adolescents. The video portrays the patient's interface with health provider and the male partner's interface and allows the universal girl to acknowledge the barriers and benefits of PID self care while providing cues for action Simple patient referral (n = 65) Index patient received standardised discharge instructions based on the 2006 CDC STI treatment guidelines
Outcomes	Primary outcomes Index patient 72‐hour follow‐up (clinical records) Medication adherence (self report during 2‐weeks postenrolment interview) Secondary outcomes Partner treatment (self report during 2‐weeks postenrolment interview) Temporary abstinence from sexual intercourse as evidence of self care (self report during 2‐weeks postenrolment interview)
Notes	The study was approved by the John Hopkins School of Medicine Institutional Review Board and the Saint Agnes Hospital Institutional Review Board. Additional approval was obtained from the Maryland State Attorney General for recruitment of children who were wards of the state at the time of diagnosis To reach 80% power to detect a statistically significant difference for the 72‐hour follow‐up visit at the P value = 0.05 level an additional 240 study subjects would have been needed. The authors were contacted for exact numbers of partners notified and treated but these numbers were not available
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Computer‐generated randomisation
Allocation concealment (selection bias)	Unclear risk	Envelopes containing the group assignment and pertinent information materials were opened by participants after informed consent to participate had been obtained from each of them
Incomplete outcome data (attrition bias) All outcomes	High risk	Only 81/126 (62%) index patients had a 2‐week follow‐up interview where information on PN were collected
Selective reporting (reporting bias)	Low risk	Outcomes in method section same as in results. No protocol 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	Unclear risk	Blinding of DIS unclear. The DIS performed the follow‐up standardised interview and completed a form. The DIS was not involved with randomisation or initial interaction with participant. Face‐to‐face interview can introduce bias