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PubMed · 10832220

Designing a research study.

R Heller
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Abstract

There are 10 steps to consider in any research study. These steps can be used to perform a critical appraisal of a published paper, or to design your study in the first place. The use of a simple system such as this can ensure that biases in study design are avoided and that an appropriate study is developed. (1) What is the study hypothesis? (2) What is the study type? (3) What are the outcome measures? Is their measurement biased in any way? (4). What is the study factor (the intervention being offered to the children)? Is there bias in this? (5) Is there a possibility of confounding? (6) What are the reference population, source population and study sample? How have the sampling and selection into the study been performed? (7) Study methods that might threaten the internal validity of the study. (8) Statistical considerations. (9) Are the results clinically and socially significant? (10) Will the conclusions of the study be relevant to the kind of patients you see, or communities you work with?

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R Heller. 2000. Designing a research study.. https://doi.org/10.1007/bf02802638

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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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