PubMed · 8734894
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M L Greenfield, J E Kuhn, E M Wojtys. A statistics primer.. https://doi.org/10.1177/036354659602400324
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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.
To determine the relative merits of two quantitative methods used to estimate the summary effects of observational studies, the authors compared two methods of meta-analysis. Each quantified the relation between oral contraceptive use and the risk for ovarian cancer. One analysis consisted of a meta-analysis using summary data from 11 published studies from the literature (MAL) in which the study was the unit of analysis, and the second consisted of a meta-analysis using individual patient data (MAP) in which the patient was the unit of analysis. The authors found excellent quantitative agreement between the summary effect estimates from the MAL and the MAP. The MAP permits analysis 1) among outcomes, exposures, and confounders not investigated in the original studies, 2) when the original effect measures differ among studies and cannot be converted to a common measure (e.g., slopes vs. correlation coefficients), and 3) when there is a paucity of studies. The MAL permits analysis 1) when resources are limited, 2) when time is limited, and 3) when original study data are not available or are available only from a biased sample of studies. In public health epidemiology, data from original studies are often accessible only to limited numbers of research groups and for only a few types of studies that have high public health priority. Consequently, few opportunities for pooled analysis exist. However, from a policy view, MAL will provide answers to many questions and will help in identifying questions for future investigation.
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