Felix 2014.
| Methods | Participants randomly assigned. Randomisation 1:1, stratified by sex and block sizes of 4. It was not clear whether 1 or both eyes were included |
|
| Participants | Participants (n = 95) > 18 years of age, from public hospital in Campinas, Brazil who had healed lesions on completion of treatment with a tablet of trimethoprim‐sulfamethoxazole (800 mg/160 mg) 2 times daily for 45 days for active recurrent Toxoplasma gondii retinochoroiditis (defined as a new focus of necrotising retinochoroiditis with active inflammation either adjacent to or remote from pre‐existing retinochoroidal scars, with positive immunoglobulin G for toxoplasmosis). Mean age, male/female ratio, and baseline BCVA: 34 years, 20/27, 20/80 (treatment); 33 years, 22/26, 20/100 (controls) | |
| Interventions | 1 trimethoprim‐sulfamethoxazole tablet (800 mg/160 mg) every 2 days (treatment) and 1 identical placebo tablet containing starch every 2 days (control) | |
| Outcomes |
Outcomes assessed for 12‐month period only. Recurrences beyond 12 months not assessed |
|
| Notes | Date study conducted: 24 August 2011 to 28 August 2012 Funding source: Fundac¸a˜o de Amparo a Pesquisa do Estado de Sa˜o Paulo, protocol 2010/15980‐2. Declaration of interest: not reported Trial registration: Influence of trimethoprim‐sulfamethoxazole for the recurrence of ocular toxoplasmosis; clinicaltrials.gov identifier: NCT01449877; http://clinicaltrials.gov/show/NCT01449877 |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Randomisation was 1:1 and was stratified by sex, and block sizes of 4 were used |
| Allocation concealment (selection bias) | Unclear risk | Nurse enrolled and assigned participants in the interventions in a masked fashion |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Participants were randomly assigned to group 1 or group 2 and received interventions in a masked fashion |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Medical events were recorded monthly on a standardised form by a member of the medical staff in a masked fashion |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 1 lost to follow‐up in each group |
| Selective reporting (reporting bias) | Unclear risk | Study protocol not available. Primary outcome, incidence of recurrences of retinochoroiditis, and secondary outcome, changes in BCVA, were well explained in report |