Schein 2000.
Methods | Study design: randomized clinical trial Number of study centers: 9 Number randomized: 19,557 operations (18,189 participants) (sample size calculations based on risk of adverse events) Study follow‐up: 1 week postsurgery |
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Participants | Country: USA and Canada Age (per operation): routine‐testing group = 73 ± 8 years; no‐testing group = 74 ± 8 years Gender (per operation): 7631 men; 11,926 women (routine‐testing group: men = 3769, women = 6006; no‐testing group: men = 3862, women = 5920) Inclusion criteria: people scheduled to undergo cataract surgery Exclusion criteria: less than 50 years old; were receiving general anesthesia; had a myocardial infarction within the preceding 3 months; had any preoperative medical testing done during the 28 days prior to enrollment; could not speak English or Spanish; 2nd eye not eligible if surgery was within 28 days of surgery in 1st randomized eye |
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Interventions | Intervention: routine testing with electrocardiography, complete blood count, and measurement of serum levels of electrolytes, urea nitrogen, creatinine, and glucose (operations scheduled: operations: n = 9775, participants: n = 9456; operations performed: operations: n = 9624, participants: n = 9411) Comparison: no preoperative testing unless the participant presented with a new or worsening condition that would warrant medical testing even if no surgery was scheduled (operations scheduled: operations: n = 9782, participants: n = 9445; operations performed: operations: n = 9626, participants: n = 9408) |
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Outcomes | Primary outcome: adverse medical events and interventions on the day of surgery and up to 7 days after surgery Secondary outcome: whether preoperative testing could have prevented the adverse event from occurring |
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Notes | Study date: 1 June 1995 to 30 June 1997 Publication language: English Participation rate: 94% Funding source: Agency for Health Care Policy and Research |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization was stratified according to clinical center, age (in decades), and health status reported by participants using blocks of 4. |
Allocation concealment (selection bias) | Low risk | Randomization was done by computer at time of enrollment. |
Masking (performance bias) Were the participants masked to the treatment group? | High risk | Participants were informed of group assignment and given a letter and study brochure to present to the healthcare provider performing the preoperative assessment. |
Masking (performance bias) Were the physicians performing the preoperative tests masked to the treatment group? | High risk | Healthcare providers performing the preoperative tests received a letter and study brochure from the participant at the time of the preoperative assessment. |
Masking (detection bias) Were the primary outcome assessors masked to the treatment group? | Low risk | Medical events and treatments were recorded by an anesthesiologist or nurse anesthetist using a standardized form during surgery, and by a standardized telephone interview conducted by a study co‐ordinator 1 week following surgery. Additional patient information was recorded by nursing staff before discharge. 2 investigators reviewed medical charts to verify adverse events, and a 3rd investigator who was masked to the treatment assignment made the final clinical judgement. |
Masking (detection bias) Were the secondary outcome assessors masked to the treatment group? | Low risk | 2 investigators reviewed medical charts to verify adverse events, and a 3rd investigator who was masked to the treatment assignment made the final clinical judgement. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Intention‐to‐treat analysis was used. Data were 100% from day of surgery and 99.8% for 1 week after surgery. |
Selective reporting (reporting bias) | Low risk | Reported the results for adverse medical events defined in methods section using a standardized form and standardized telephone interview |