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A Utilitarian Perspective on Risk Quantification for Clinical Significance in Binary Outcomes.

¹Pukyong National University, Busan, Korea.

Inquiry : a Journal of Medical Care Organization, Provision and Financing

|April 24, 2024

Summary

This study introduces risk difference (RD) as a preferred effect size (ES) for medical research, enhancing clarity on clinical intervention impact and patient benefits. It advocates for reporting RDs with baseline risks for transparent, patient-centered decision-making.

Keywords:

control rate dichotomous outcomes primary outcome measure reference risk relative risk

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Area of Science:

Medical Statistics
Clinical Research Methodology
Evidence-Based Medicine

Background:

Null hypothesis significance testing (NHST) is being supplemented by estimation statistics like effect sizes (ESs) and confidence intervals (CIs).
Current methods for binary outcomes may not fully convey clinical significance or patient impact.
A need exists for improved statistical measures in medical research to enhance applicability to patient care.

Purpose of the Study:

To evaluate the expression of ESs and CIs for binary outcomes in medical research.
To propose a utilitarian framework for assessing clinical significance using risk difference (RD).
To compare the performance of RD against other measures (RR, OR, Cohen's h) in individual studies and meta-analyses.

Main Methods:

Proposed a utilitarian framework emphasizing beneficiaries and impact level.
Introduced minimal clinically important risk difference (MCIRD) based on event magnitude (EM).
Compared statistical power of RD versus RR, OR, and Cohen's h in individual studies; assessed visual information conveyance in meta-analyses.

Main Results:

Risk difference (RD) maintains statistical power comparable to other measures in individual studies.
RDs provide clarity on clinical intervention impact without compromising statistical integrity.
Meta-analyses using RDs enhance transparency, uncover heterogeneity, and address misaligned assumptions.

Conclusions:

Adopting RD as a preferred ES, reported with baseline risks (BRs), fosters a transparent, patient-focused research ethos.
This approach quantifies clinical effectiveness, facilitating research application to patient care and shared decision-making.
Recommends standardized presentation of RDs and BRs for accurate representation of treatment effects.