Spoor 1980.
Methods | Study design: Randomized, double‐masked, placebo‐controlled clinical trial. Exclusions after randomization: None. Losses to follow‐up: None. Intention‐to‐treat: All participants were analyzed in the group to which they had been randomly assigned. Sample size calculations: Not reported. |
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Participants | Country: USA. Dates: September 1975 to December 1977. Number randomized: 43: 23 to prednisone, 20 to placebo. Age: Mean age: prednisone group 20.1 years (range 5 to 61 years), placebo group 21.2 years (range 9 to 51 years). Sex: 16 (70%) of prednisone group, 16 (80%) of placebo group were male. Race: 14 (61%) white participants, 6 (26%) Hispanic participants, and 3 (13%) black participants in prednisone group; 11 (55%) white participants, 7 (35%) Hispanic participants, and 2 (10%) black participants in placebo group. Sickle cell disease: Not reported. Participants appeared to be balanced with respect to baseline characteristics. Inclusion criteria: Traumatic hyphema. Exclusion criteria:
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Interventions | Treatment: Oral prednisone 40 mg/day for adults and children > 10 years; 15 mg/day for children ages 4 to 10 years; and 10 mg/day for children ages 18 months to 4 years, for 7 days. Control: Lactose placebo capsules administered daily for 7 days. Treatment for both groups included:
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Outcomes | Primary outcome: Risk of secondary hemorrhage, assessed daily for 7 days, using slit‐lamp exam, documented by drawings or photography. Secondary outcomes:
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Randomized, but method of allocation not reported. |
Allocation concealment (selection bias) | Low risk | Allocation was concealed from investigators by use of encoded capsules prepared by pharmacy. |
Blinding (performance bias and detection bias) Participants | Low risk | Participants masked to treatment assignment by use of encoded capsules prepared by pharmacy. "Neither the doctor nor the patient knew which capsule the patient was receiving until the conclusion of the course of treatment and follow‐up." |
Blinding (performance bias and detection bias) Personnel and outcome assessors | Low risk | Healthcare providers and outcomes assessors masked to treatment assignment by use of encoded capsules prepared by pharmacy. "Neither the doctor nor the patient knew which capsule the patient was receiving until the conclusion of the course of treatment and follow‐up." |
Incomplete outcome data (attrition bias) Primary outcome | Low risk | There were no exclusions and no loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Incomplete outcome data (attrition bias) Secondary outcomes | Low risk | There were no exclusions and no loss to follow‐up. All participants were analyzed in the group to which they had been randomly assigned. |
Selective reporting (reporting bias) | Low risk | Reported results for primary and secondary outcomes |
Other bias | Low risk | No other sources of potential bias were identified. |