Dataset Information

Strategies to Improve the Clinical Outcomes for Direct-to-Consumer Pharmacogenomic Tests.

ABSTRACT: Direct-to-consumer genetic tests (DTC-GT) have become a bridge between marketing and traditional healthcare services. After earning FDA endorsement for such facilities, several fast-developing companies started to compete in the related area. Pharmacogenomic (PGx) tests have been introduced as potentially one of the main medical services of such companies. Most of the individuals will be interested in finding out about the phenotypic consequences of their genetic variants and molecular risk factors against diverse medicines they take or will take later. Direct-to-consumer pharmacogenomic tests (DTC-PT) is still in its young age, however it is expected to expand rapidly through the industry in the future. The result of PGx tests could be considered as the main road toward the implementation of personalized and precision medicine in the clinic. This narrative critical review study provides a descriptive overview on DTC-GT, then focuses on DTC-PT, and also introduces and suggests the potential approaches for improving the clinical related outcomes of such tests on healthcare systems.

SUBMITTER: Tafazoli A

PROVIDER: S-EPMC7999840 | biostudies-literature | 2021 Mar

REPOSITORIES: biostudies-literature

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Strategies to Improve the Clinical Outcomes for Direct-to-Consumer Pharmacogenomic Tests.

Tafazoli Alireza A Guggilla Rama Krishna RK Kamel-Koleti Zahra Z Miltyk Wojciech W

Genes 20210303 3

Direct-to-consumer genetic tests (DTC-GT) have become a bridge between marketing and traditional healthcare services. After earning FDA endorsement for such facilities, several fast-developing companies started to compete in the related area. Pharmacogenomic (PGx) tests have been introduced as potentially one of the main medical services of such companies. Most of the individuals will be interested in finding out about the phenotypic consequences of their genetic variants and molecular risk fact ...[more]

PMID: 33802585

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Project description:ImportanceThe recent provision of direct-to-consumer (DTC) Anti-Mullerian Hormone (AMH) testing in several countries has been contentious, particularly due to concerns about judicious testing and informed consent.ObjectiveTo describe and analyze information on websites that sell DTC AMH tests.Design, setting, and participantsQualitative study including content analysis of text information from websites in multiple countries that sell AMH tests DTC. The top 50 search results from 4 different internet search strings were captured and reviewed for eligibility. Data were extracted in March 2022 and analyzed from April 2022 to July 2023.Main outcomes and measuresThemes and categories were derived from the website content using a conventional inductive approach, with a particular focus on information content, quality and accuracy, as well as the tone and language used.ResultsTwenty-seven websites across 7 different countries formed the sample for analysis. Information varied considerably across websites and was organized into 6 overarching categories: (1) whether a test description was included (25 websites [93%]); (2) statements about what the test can do, which included indicating ovarian reserve (26 websites [96%]) and indicating likelihood of conceiving (20 websites [74%]); (3) statements about the usefulness of the test result, which included enabling women to adjust their reproductive timeline (11 websites [41%]) and determining whether egg freezing was a viable option (8 websites [30%]); (4) blood collection method (ie, through a laboratory or an at-home sample); (5) promotion tactics, such as stating the convenience of testing (24 websites [89%]) and using language promoting empowerment and control (7 websites [26%]); and (6) statements about limitations of the test, which included polycystic ovary syndrome falsely inflating AMH levels (13 websites [48%]) and that it cannot accurately predict chances of conceiving (9 websites [33%]).Conclusion and relevanceIn this qualitative study including content analysis, most websites selling DTC AMH tests included false and misleading claims which might lead consumers to purchase an AMH test in the belief that it can reliably predict fertility potential and age of menopause. Depending on the test result, this may in turn lead to misplaced anxiety or reassurance about one's fertility and modifications to subsequent conception or contraceptive plans and behavior.

Dataset Information

Strategies to Improve the Clinical Outcomes for Direct-to-Consumer Pharmacogenomic Tests.

Publications

Strategies to Improve the Clinical Outcomes for Direct-to-Consumer Pharmacogenomic Tests.

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