CHARACTERISTICS OF STUDIES
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 |
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 |
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 coordinator 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 |