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Related Experiment Video

Updated: Jan 14, 2026

Validation of a Psychosocial Intervention on Body Image in Older People: An Experimental Design

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Published on: May 31, 2021

Registration and multiple outcome testing in the HEALing communities study.

Dennis M Gorman¹, Ben G Fitzpatrick²

¹Department of Epidemiology & Biostatistics, School of Public Health, Texas A&M University, College Station, TX, USA.

The International Journal on Drug Policy

|October 18, 2025

Summary

This summary is machine-generated.

The HEALing Communities Study (HCS) reported a null result for its primary opioid overdose outcome. Subsequent analyses of additional outcomes may be subject to statistical errors due to uncorrected multiplicity.

Keywords:

False discovery rate Familywise error rate HEALing Communities Study Multiple outcome testing Multiplicity Opioid and drug overdose Type I error

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Area of Science:

Public Health
Clinical Trials
Biostatistics

Background:

The HEALing Communities Study (HCS) is a randomized control trial investigating interventions for opioid overdose.
The study initially registered one primary opioid overdose outcome.
Additional outcomes and sub-measures were introduced post-commencement of data collection.

Purpose of the Study:

To critically evaluate the statistical reporting practices of the HEALing Communities Study.
To assess the potential impact of uncorrected multiplicity on study conclusions regarding opioid overdose interventions.
To propose improvements for reporting clinical trial results, particularly concerning multiple outcome measures.

Main Methods:

Review of published protocols and findings from the HEALing Communities Study.
Analysis of the introduction of multiple outcome measures after study initiation.
Assessment of statistical testing procedures, focusing on the need for multiplicity correction.

Main Results:

The HCS reported a null finding for its primary, registered outcome.
Numerous additional outcomes were analyzed, with some reporting statistically significant results.
Multiplicity correction was not applied to these secondary and exploratory outcomes, increasing the risk of Type I errors.

Conclusions:

Conclusions regarding the HCS intervention's effectiveness based on uncorrected secondary outcomes are likely unreliable due to potential Type I errors.
Journal peer review is a critical juncture for addressing issues of multiplicity and ensuring accurate interpretation of clinical trial data.
Recommendations include limiting causal inferences from exploratory analyses and requiring multiplicity corrections or clear distinctions for P-values.