Silveira 2002.
Methods | Randomised using sealed envelopes (information from authors). Participant could have retinochoroidal lesion in 1 or both eyes |
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Participants | Participants with chronic recurrent toxoplasma retinochoroiditis, south Brazil (treated n = 61 (28 unilateral and 33 bilateral disease) (age range 8 to 50 years); untreated n = 63 (35 unilateral and 28 bilateral disease) (age range 7 to 53 years)) | |
Interventions | Trimethoprim 160 mg and sulfamexacocol 800 mg, both orally every 3 days for 20 months versus no treatment | |
Outcomes |
Published paper does not report losses to follow‐up; we obtained this information from authors. At 14 months, 6 lost in treatment group, 4 lost in control group. At 17 months, 19 lost in treatment group and 13 in control group. No data given on visual acuity |
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Notes | Date study conducted: April 1998 to not reported Funding source: Conselho Nacional de Desenvolvimento Cientı´fı´co e Tecnolo´gico (CNPq), Coordenac¸a˜o de Aperfeic¸oamento de Pessoal de Nı´vel Superior (CAPES), Clı´nica Silveira, and Fundac¸a˜o de Amparo a` Pesquisa do Estado de Sa˜o Paulo (FAPESP) Declaration of interest: Not reported. Trial registration: Not reported. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | “Computer generated randomisation list.” |
Allocation concealment (selection bias) | Low risk | No relevant statement in published study, but the authors stated that closed envelopes were opened only after eligibility criteria were confirmed (unpublished data) |
Blinding of participants and personnel (performance bias) All outcomes | High risk | “Medication was administered in an unmasked fashion.” |
Blinding of outcome assessment (detection bias) All outcomes | High risk | No masking, and participants followed up only by the clinician responsible for the trial |
Incomplete outcome data (attrition bias) All outcomes | High risk | 10% lost to follow‐up by 14 months. Slightly higher losses in treatment group (6/61 versus 4/63), possibly reflecting a need to keep attending in the hope of eventually being given antibiotics. No prespecified duration of trial, as lesion recurrence was the criterion for ceasing follow‐up |
Selective reporting (reporting bias) | Low risk | Recurrence was primary outcome and endpoint for follow‐up |
BCVA: best corrected visual acuity