PubMed · 8057071
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A O Goldstein. 1994. Avoidable hospitalizations.. https://pubmed.ncbi.nlm.nih.gov/8057071/
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In randomized controlled trials (RCTs), study participants and research personnel are often blinded to minimize biases related to knowing treatment allocation. To determine if blinding was effective, participants may be asked which treatment they believe they received ("treatment guess"). This descriptive review characterized blinding assessment (BA) reporting in pharmacotherapy and neuromodulation neuropathic pain RCTs. Of 288 papers, 36 (12.5%) reported a BA. One paper reported the results of 2 studies, so in total 37 studies with a BA were assessed. Of these, 19 were crossover, 17 parallel, and 1 partial crossover in design. All 37 studies assessed participant blinding, and 10 also assessed investigator blinding. Approximately 27% included an "unsure" answer option for treatment guess, and 38% asked the reason for the guess. There were no clear patterns in BA reporting across time nor based on treatment type. Seventeen trials provided sufficient data to calculate Bang Blinding Index (BI) to determine blinding success. Participants remained blinded (BI = 0 ± 0.2) in 10/17 placebo and 10/17 treatment arms, 6 placebo and 5 treatment arms had a BI > 0.2 suggesting possible unblinding, whereas 1 placebo and 2 treatment arms had a BI < -0.2 suggesting misinformed guessing. Overall, we found that BAs are done in a minority of published neuropathic pain trials and with variable methodology. Given the importance of minimizing risk of bias because of treatment unblinding, future studies should consider including BAs, and further consensus building is necessary to determine if and how BAs should be conducted and interpreted in analgesic clinical trials.
OBJECTIVES: The purpose of this study was to determine whether performing coronary artery bypass surgery on high-risk patients adversely affects the risk-adjusted mortality rates for patients of surgeons and hospitals in New York State compared with the impact of performing surgery on more routine patients. METHODS: Risk-adjusted mortality-rates were calculated for 31 hospitals and 87 surgeons for high-risk (a predicted mortality rate of at least 7.5%) and low-risk patients during the time period 1990 to 1992. RESULTS: The risk-adjusted mortality for all high-risk patients was lower (2.94%) than the risk-adjusted mortality for other patients (3.02%). Fifteen of the 31 hospitals had a lower risk-adjusted mortality for all patients than they did for low-risk patients only, and no differences in either direction were statistically significant. Forty-one of 87 surgeons (47%) had risk-adjusted mortality for all patients that was at least as low as the risk-adjusted mortality for low-risk patients. In general, hospitals and surgeons with the lowest risk-adjusted mortality for all cases also had the lowest risk-adjusted mortality for high-risk cases. CONCLUSIONS: The authors conclude that there is no systematic bias against operating on high-risk coronary artery bypass graft patients in the risk-adjusted performance system in New York.