Article Text

Original research
Direct-to-consumer tests advertised online in Australia and their implications for medical overuse: systematic online review and a typology of clinical utility
  1. Patti Shih1,
  2. Pauline Ding2,
  3. Stacy M Carter1,
  4. Fiona Stanaway3,
  5. Andrea R Horvath4,5,
  6. Daman Langguth6,
  7. Mirette Saad7,
  8. Andrew St John8,
  9. Katy Bell3
  1. 1School of Health & Society, University of Wollongong, Wollongong, New South Wales, Australia
  2. 2School of Mathematics and Applied Statistics, University of Wollongong, Wollongong, New South Wales, Australia
  3. 3School of Public Health, University of Sydney, Sydney, New South Wales, Australia
  4. 4NSW Health Pathology, Sydney, New South Wales, Australia
  5. 5University of New South Wales, Kensington, New South Wales, Australia
  6. 6Sullivan Nicolaides Pathology, Wesley Hospital, Brisbane, Queensland, Australia
  7. 7Australian Clinical Labs, Victorian Central Laboratory Headquarters, Clayton, Victoria, Australia
  8. 8Drajon Health, Toodyay, Western Australia, Australia
  1. Correspondence to Dr Patti Shih; pshih{at}uow.edu.au

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.

  • health services administration & management
  • pathology
  • decision making
  • health services accessibility

Data availability statement

All data relevant to the study are included in the article or uploaded as online supplemental information.

https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

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Data availability statement

All data relevant to the study are included in the article or uploaded as online supplemental information.

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Footnotes

  • Twitter @KatyJLBell

  • Contributors PS conceptualised the study and led data collection, with theoretical contributions from KB, SMC and FS. PD provided technical advice and analysis of the quantitative data. ARH, ASJ, DL and MS provided technical advice. All authors contributed to the data analysis and approved the submitted manuscript. PS is responsible for the overall content as guarantor.

  • Funding This study received funding from the Department of Health and Aged Care, Australian Government, National Health and Medical Research Council, grant number #1104136 & #2006545.

  • Competing interests None declared.

  • Patient and public involvement Patients and/or the public were involved in the design, or conduct, or reporting, or dissemination plans of this research. Refer to the Methods section for further details.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.