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PubMed · 9027513

Basic methods for sensitivity analysis of biases.

S Greenland
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Abstract

BACKGROUND: Most discussions of statistical methods focus on accounting for measured confounders and random errors in the data-generating process. In observational epidemiology, however, controllable confounding and random error are sometimes only a fraction of the total error, and are rarely if ever the only important source of uncertainty. Potential biases due to unmeasured confounders, classification errors, and selection bias need to be addressed in any thorough discussion of study results. METHODS: This paper reviews basic methods for examining the sensitivity of study results to biases, with a focus on methods that can be implemented without computer programming. CONCLUSION: Sensitivity analysis is helpful in obtaining a realistic picture of the potential impact of biases.

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BiasCase-Control StudiesEpidemiologic MethodsHumansLung NeoplasmsOccupational DiseasesOccupational ExposureOdds RatioReproducibility of ResultsResins, PlantRisk FactorsSensitivity and SpecificityJournal Article

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S Greenland. 1996. Basic methods for sensitivity analysis of biases.. https://pubmed.ncbi.nlm.nih.gov/9027513/

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Assessment of blinding in pharmacotherapy and noninvasive neuromodulation randomized controlled trials for neuropathic pain in adults.

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 &#xb1; 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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