PubMed · 8232990
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R W Stout. 1993. Another viewpoint.. https://pubmed.ncbi.nlm.nih.gov/8232990/
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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.
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A preventive program is only of value if it has proven benefits that outweigh any adverse consequences; unfortunately, determination of the clinical significance of reported benefits is not always easy. The first article of this series discussed the confusion caused by reporting results in terms of relative rates. In this article, 10 other pitfalls that may lead to misunderstanding of the degree of benefits are reviewed. These pitfalls are: the type of outcome chosen (surrogate v. clinically significant), the risk level in the population screened, the interval between the intervention and the benefit, the duration of intervention required to achieve the benefit, the overshadowing of one benefit by another, the application of a benefit for one variant of a disease to another variant, lower benefits in community settings than in clinical trials, publication bias, preferential citation of studies showing beneficial effects and "false-negative" results of studies. These pitfalls are illustrated through examples from the current medical literature.