Section H
Scientific Methods
How medical knowledge is made and checked.
For Scientific Readers
A guide to the questions that connect measurement, study design, validation, analysis and transparent reporting.
H02Formulating a Research Question
A clear research question connects the population, intended use, comparison and outcome to an appropriate study design.
H03Protocols and Prespecified Analysis
Advance planning makes research decisions visible and helps limit selective analysis and reporting.
H04Sampling and Representativeness
Recruitment and selection determine which people a study describes and how far its findings may extend.
H05Sample Size and Statistical Power
Study size should reflect the research goal, desired precision and explicit assumptions rather than a universal numerical rule.
H06Reference Standards and Comparators
The choice and application of a reference standard or comparator shape what an evaluation can establish.
H07Analytical Validation
Analytical validation examines whether a measurement method measures its intended target with performance suitable for its stated use.
H08Clinical Validation
Clinical validation examines whether a test or model provides valid information about a clinical condition or outcome in its intended population.
H09Clinical Utility
Clinical utility concerns whether using a test or model leads to worthwhile effects on care compared with a relevant alternative.
H10External and Prospective Evaluation
External evaluation tests transfer beyond development data, while prospective evaluation plans observation forward in time.
H11Reproducibility and Provenance
Traceable data and versioned workflows help others understand, check and repeat a scientific analysis.
H12Reporting Guidelines
Structured reporting helps readers understand and assess a study, but checklist completion does not guarantee reliable research.
H13Evidence Extraction Method
This proposed method provides a structured way to record study findings, limitations and source context without overstating the evidence.