Lira 2001.
Methods | Study design: randomized clinical trial Number of study centers: 1 (State University of Campinas) Number randomized: 1025 (sample size calculations based on risk of adverse events) Study follow‐up: up to 60 days postsurgery |
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Participants | Country: Brazil Age: 66.5 ± 11.6 years, range 40 to 97 years (routine‐testing group = 66.4 ± 11.9 years; selective‐testing group = 66.7 ± 11.4 years) Gender: 547 men, 478 women (routine‐testing group: men = 279, women = 233; selective‐testing group: men = 268, women = 245) Inclusion criteria: people scheduled to undergo cataract surgery Exclusion criteria: less than 40 years old; undergoing surgery on the 2nd eye; were receiving general anesthesia; had a myocardial infarction within the preceding 3 months |
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Interventions | Intervention: routine testing with a 12‐lead electrocardiogram, a complete blood count, and measurements of serum glucose (n = 512) Comparison: selective testing defined by no preoperative testing unless the participant presented with a new or worsening condition that would warrant medical testing even if no surgery was scheduled (n = 513) |
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Outcomes | Primary outcome: rate of complications during the perioperative period Secondary outcomes: rate of cancellation of surgery; visual acuity |
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Notes | Study date: 10 February 2000 to 10 January 2001 Publication languages: English and Portuguese Surgery: extra capsular extraction performed by residents under training |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization using blocks of 4 participants |
Allocation concealment (selection bias) | Unclear risk | Not described |
Masking (performance bias) Were the participants masked to the treatment group? | High risk | Participants either had preoperative testing done or did not. |
Masking (performance bias) Were the physicians performing the preoperative tests masked to the treatment group? | High risk | Physicians performing the preoperative medical assessment knew for which participants to conduct preoperative testing. |
Masking (detection bias) Were the primary outcome assessors masked to the treatment group? | Low risk | Medical events and treatments were recorded by an ophthalmologist or nurse using a standardized form during surgery. The researchers reviewing the forms for classifying adverse events were masked to the treatment assignments. |
Masking (detection bias) Were the secondary outcome assessors masked to the treatment group? | Unclear risk | It was unclear who made the decision to cancel surgeries, or when those decisions were made. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Primary outcome data are presented for all participants who underwent surgery, thus for all participants at risk for complications due to cataract surgery. |
Selective reporting (reporting bias) | Low risk | Reported the results for adverse medical events defined in methods section using a standardized form |