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. 2016 May 20;2016(5):CD002218. doi: 10.1002/14651858.CD002218.pub2

Silveira 2002.

Methods Randomised using sealed envelopes (information from authors).
Participant could have retinochoroidal lesion in 1 or both eyes
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
  1. Recurrence of 1 or more retinochoroidal lesions by 14 months

  2. Mean time to first recurrence

  3. Intraocular inflammation at unspecified time point based on visual acuity and anterior chamber inflammation


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
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.
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study, but the authors stated that closed envelopes were opened only after eligibility criteria were confirmed (unpublished data)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