Cavallini 2004.
Methods | Study design: randomized clinical trial Number of study centers: 1 (University of Modena and Reggio Emilia) Number randomized: 1276 (sample size calculations based on risk of adverse events) Study follow‐up: 1 month postsurgery |
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Participants | Country: Italy Age: not reported Gender: included men and women Inclusion criteria: patients admitted to the day surgery section at the Institute of Ophthalmology for outpatient cataract surgery under local anesthesia Exclusion criteria: ongoing treatment with anticoagulants and subcutaneous insulin therapy |
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Interventions | Intervention: physician review of preoperative testing, defined as routine medical tests and electrocardiograms (n = 638) Comparison: no physician review of preoperative testing, test results kept in sealed envelopes (n = 638) |
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Outcomes | Primary outcome: ocular adverse events, including intraoperative or postoperative adverse events Secondary outcomes: systemic adverse events defined as intra‐ or postoperative occurrence of acute respiratory, cardio‐circulatory, or neuropsychiatric disease; or decompensation in analogous, established chronic disease |
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Notes | Study date: 1 October 2002 to 30 November 2003 Publication language: English |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization list generated by Randomization Center, which was separate from the study center. |
Allocation concealment (selection bias) | Low risk | Medical staff at study center called into Randomization Center for participant allocation after patients were enrolled in study. |
Masking (performance bias) Were the participants masked to the treatment group? | Low risk | Participants were informed of the aims and methods for the study at enrollment, however all participants underwent preoperative testing. |
Masking (performance bias) Were the physicians performing the preoperative tests masked to the treatment group? | Unclear risk | The physicians evaluating the preoperative tests were not masked to the participants in the testing group, however they only received sealed envelopes for the participants in the non‐testing group and were not informed of participants' identities or surgery dates. It is unclear if the physician evaluating the preoperative tests was also the physician performing the surgery. |
Masking (detection bias) Were the primary outcome assessors masked to the treatment group? | Unclear risk | Ocular outcomes were assessed by clinical records at the time of discharge (intraoperative outcomes) and by telephone interviews 1 month after surgery (postoperative outcomes). It is unclear if the clinical records contained the treatment assignment or if the interviewers were informed of the treatment assignment. |
Masking (detection bias) Were the secondary outcome assessors masked to the treatment group? | Unclear risk | Systemic outcomes were assessed by clinical records at the time of discharge (intraoperative outcomes) and by telephone interviews and primary care examinations 1 month after surgery (postoperative outcomes). It is unclear if the clinical records contained the treatment assignment or if the interviewers or primary care physicians were informed of the treatment assignment. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up is reported. Reported results are based on total number randomized. |
Selective reporting (reporting bias) | Low risk | Reported all ocular and systemic adverse events that occurred intraoperatively or postoperatively |