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How to conduct a high-quality original study on a prognostic research topic
Xiaomei Yao1, Emily Vella1, Melissa Brouwers2
1Department of Oncology, McMaster University, Hamilton, Ontario, Canada.
Surgical Oncology
|November 21, 2018
Summary
This educational guide details conducting high-quality prognostic research. It outlines four study types and essential methodological components for robust study design, planning, and analysis.
Area of Science:
- Methodology in medical research
- Biostatistics and epidemiology
Background:
- Prognostic research is crucial for understanding disease progression and patient outcomes.
- Methodological rigor is essential for generating reliable prognostic information.
- Previous guidance has not comprehensively addressed the nuances of different prognostic study types.
Purpose of the Study:
- To provide a methodological framework for conducting high-quality original studies in prognostic research.
- To delineate four distinct types of prognostic studies and their characteristics.
- To offer guidance on formulating research questions, study planning, and data analysis for prognostic research.
Main Methods:
- Classification of prognostic studies into four types: fundamental prognostic research (Type I), prognostic factors research (Type II), prediction model research (Type III), and stratified medicine research (Type IV).
- Introduction of "PFOT" (Population, Factor[s], Outcome, Time) and "PIFOT" (Population, Intervention, Factor[s], Outcome, Time) frameworks for research question development.
- Emphasis on critical methodological aspects including study registration, sample size calculation, handling confounders and missing data, internal validation for prediction models, and interaction testing for stratified medicine research.
Main Results:
- Defined characteristics for each of the four prognostic study types.
- Recommended specific components for research questions based on study type (PFOT/PIFOT).
- Highlighted key considerations for study planning, analysis, and reporting, including validation and interaction testing.
Conclusions:
- High-quality prognostic research requires a collaborative effort between clinicians, methodologists, and statisticians.
- Adherence to methodological best practices ensures the validity and utility of prognostic studies.
- This framework aims to improve the quality and impact of prognostic research findings.
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