Draft of chapter about study design - #41
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…of study design and considerations chapter
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to-do before being ready for review:
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* note not all html features will be properly displayed in the "quick preview" but it will give you a rough idea. Updated at 2026-08-17 with changes from the latest commit 45d0a01 |
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| In this chapter, we describe a variety of clinical study designs (distinguishing between a clinical trial and an observational study, and several commons types of observational studies) and discuss several considerations for collecting data and conducting studies. We provide an in-depth description of case report forms and discuss possible types of bias in clinical studies. | ||
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| Throughout this chapter, we will use the word **outcome** to refer to the health-related effect that we would like to study, often the occurrence of a disease or condition. We use the term **exposure** to refer to a factor that may influence the outcome and that differs across groups being compared. An exposure may be a treatment, behavior, environmental factor, genetic characteristic, or demographic attribute. We use the term **intervention** to refer to an exposure that is deliberately assigned by researchers within a clinical trial. The goal of many clinical studies is to understand the relationship between an exposure or intervention and an outcome. |
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good opportunity for a visual to compare these terms
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| ## Types of Clinical Studies | ||
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| Clinical data generated from clinical trials and observational studies form the backbone of evidence-based medicine. The ability to analyze and interpret this data enables researchers and clinicians to answer a variety of important questions that directly impact patient care, treatment decisions, and healthcare policies. |
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I found this section to be phrased slightly confusingly... as if clinical trials and observational studies creates clinical data which is then analyzed for research, as opposed to these being forms of research. Perhaps we could rephrase
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@carriewright11 let me know what you think of the edit above.
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looks good! just some minor thoughts
Co-authored-by: Carrie Wright <23014755+carriewright11@users.noreply.github.com>
Co-authored-by: Carrie Wright <23014755+carriewright11@users.noreply.github.com>
…_Management into study_design Bringing in changes from code review
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@carriewright11 I've included your suggestions, and drafted a different start to the clinical studies section based on your comment above and a meta-analysis section. I also added a placeholder for the image you mentioned for the introduction. Let me know how it looks, and if there are additional changes before we submit this for review. |
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Looks good! I like the intro much better.I think we should differentiate mega and meta analysis - combining raw data vs summary stats |
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Purpose/implementation Section
Add section about study design.
What changes are being implemented in this Pull Request?
Include new material in file 01c-how_to_collect_data.Rmd.
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New content/chapter is in an Rmd file with this kind of format and headers.
New content/chapter contains Learning Objectives and are in the correct format.
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