Direct-to-consumer tests advertised online in Australia and their implications for medical overuse: systematic online review and a typology of clinical utility

Authors

Patti Shih, University of Wollongong
Pauline Ding, University of Wollongong
Stacy M. Carter, University of Wollongong
Fiona Stanaway, The University of Sydney School of Public Health
Andrea R. Horvath, NSW Health Pathology
Daman Langguth, The Wesley Hospital
Mirette Saad, Victorian Central Laboratory Headquarters
Andrew St John, Drajon Health
Katy Bell, The University of Sydney School of Public Health

Publication Name

BMJ open

Abstract

OBJECTIVES: The objective of this study is to map the range and variety of direct-to-consumer (DTC) tests advertised online in Australia and analyse their potential clinical utility and implications for medical overuse. DESIGN: Systematic online search of DTC test products in Google and Google Shopping. DTC test advertisements data were collected and analysed to develop a typology of potential clinical utility of the tests at population level, assessing their potential benefits and harms using available evidence, informed by concepts of medical overuse. RESULTS: We identified 484 DTC tests (103 unique products), ranging from $A12.99 to $A1947 in cost (mean $A197.83; median $A148.50). Using our typology, we assigned the tests into one of four categories: tests with potential clinical utility (10.7%); tests with limited clinical utility (30.6%); non-evidence-based commercial 'health checks' (41.9%); and tests whose methods and/or target conditions are not recognised by the general medical community (16.7%). Of the products identified, 56% did not state that they offered pretest or post-test consultation, and 51% did not report analytical performance of the test or laboratory accreditation. CONCLUSIONS: This first-in-Australia study shows most DTC tests sold online have low potential clinical utility, with healthy consumers constituting the main target market. Harms may be caused by overdiagnosis, high rates of false positives and treatment decisions led by non-evidence-based tests, as well as financial costs of unnecessary and inappropriate testing. Regulatory mechanisms should demand a higher standard of evidence of clinical utility and efficacy for DTC tests. Better transparency and reporting of health outcomes, and the development of decision-support resources for consumers are needed.

Open Access Status

This publication may be available as open access

Volume

13

Issue

12

First Page

e074205