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Assessment of pharmacogenetic tests: presenting measures of clinical validity and potential population impact in association studies.

ABSTRACT: The progressing discovery of genetic variants associated with drug-related adverse events has raised expectations for pharmacogenetic tests to improve drug efficacy and safety. To further the use of pharmacogenetics in health care, tests with sufficient potential to improve efficacy and safety, as reflected by good clinical validity and population impact, need to be identified. The potential benefit of pharmacogenetic tests is often concluded from the strength of the association between the variant and the adverse event; measures of clinical validity are generally not reported. This paper describes measures of clinical validity and potential population health impact that can be calculated from association studies. We explain how these measures are influenced by the strength of the association and by the frequencies of the variant and the adverse event. The measures are illustrated using examples of testing for HLA-B*5701 associated with abacavir-induced hypersensitivity and SLCO1B1 c.521T>C (*5) associated with simvastatin-induced adverse events.

SUBMITTER: Tonk ECM

PROVIDER: S-EPMC5549182 | biostudies-literature | 2017 Jul

REPOSITORIES: biostudies-literature

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Assessment of pharmacogenetic tests: presenting measures of clinical validity and potential population impact in association studies.

Tonk E C M ECM Gurwitz D D Maitland-van der Zee A-H AH Janssens A C J W ACJW

The pharmacogenomics journal 20160510 4

The progressing discovery of genetic variants associated with drug-related adverse events has raised expectations for pharmacogenetic tests to improve drug efficacy and safety. To further the use of pharmacogenetics in health care, tests with sufficient potential to improve efficacy and safety, as reflected by good clinical validity and population impact, need to be identified. The potential benefit of pharmacogenetic tests is often concluded from the strength of the association between the vari ...[more]

PMID: 27168098

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Project description:IntroductionClinicians rely on certain physical examination tests to diagnose and potentially grade ankle sprains and ankle instability. Diagnostic error and inaccurate prognosis may have important repercussions for clinical decision-making and patient outcomes. Therefore, it is important to recognize the diagnostic value of orthopaedic tests through understanding the reliability and validity of these tests.ObjectiveTo systematically review and report evidence on the reliability and validity of orthopaedic tests for the diagnosis of ankle sprains and instability.MethodsPubMed, CINAHL, Scopus, and Cochrane databases were searched from inception to December 2021. In addition, the reference list of included studies, located systematic reviews, and orthopaedic textbooks were searched. All articles reporting reliability or validity of physical examination or orthopaedic tests to diagnose ankle instability or sprains were included. Methodological quality of the reliability and the validity studies was assessed with The Quality Appraisal for Reliability studies checklist and the Quality Assessment of Diagnostic Accuracy Studies-2 respectively. We identified the number of times the orthopaedic test was investigated and the validity and/or reliability of each test.ResultsOverall, sixteen studies were included. Three studies assessed reliability, eight assessed validity, and five evaluated both. Overall, fifteen tests were evaluated, none demonstrated robust reliability and validity scores. The anterolateral talar palpation test reported the highest diagnostic accuracy. Further, the anterior drawer test, the anterolateral talar palpation, the reverse anterior lateral drawer test, and palpation of the anterior talofibular ligament reported the highest sensitivity. The highest specificity was attributed to the anterior drawer test, the anterolateral drawer test, the reverse anterior lateral drawer test, tenderness on palpation of the proximal fibular, and the squeeze test.ConclusionOverall, the diagnostic accuracy, reliability, and validity of physical examination tests for the assessment of ankle instability were limited. Physical examination tests should not be used in isolation, but rather in combination with the clinical history to diagnose an ankle sprain. Preliminary evidence suggests that the overall validity of physical examination for the ankle may be better if conducted five days after the injury rather than within 48 h of injury.

Project description:BackgroundOnline dietary assessment tools can reduce administrative costs and facilitate repeated dietary assessment during follow-up in large-scale studies. However, information on bias due to measurement error of such tools is limited. We developed an online 24-h recall (myfood24) and compared its performance with a traditional interviewer-administered multiple-pass 24-h recall, assessing both against biomarkers.MethodsMetabolically stable adults were recruited and completed the new online dietary recall, an interviewer-based multiple pass recall and a suite of reference measures. Longer-term dietary intake was estimated from up to 3?×?24-h recalls taken 2 weeks apart. Estimated intakes of protein, potassium and sodium were compared with urinary biomarker concentrations. Estimated total sugar intake was compared with a predictive biomarker and estimated energy intake compared with energy expenditure measured by accelerometry and calorimetry. Nutrient intakes were also compared to those derived from an interviewer-administered multiple-pass 24-h recall.ResultsBiomarker samples were received from 212 participants on at least one occasion. Both self-reported dietary assessment tools led to attenuation compared to biomarkers. The online tools resulted in attenuation factors of around 0.2-0.3 and partial correlation coefficients, reflecting ranking intakes, of approximately 0.3-0.4. This was broadly similar to the more administratively burdensome interviewer-based tool. Other nutrient estimates derived from myfood24 were around 10-20% lower than those from the interviewer-based tool, with wide limits of agreement. Intraclass correlation coefficients were approximately 0.4-0.5, indicating consistent moderate agreement.ConclusionsOur findings show that, whilst results from both measures of self-reported diet are attenuated compared to biomarker measures, the myfood24 online 24-h recall is comparable to the more time-consuming and costly interviewer-based 24-h recall across a range of measures.

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Assessment of pharmacogenetic tests: presenting measures of clinical validity and potential population impact in association studies.

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Assessment of pharmacogenetic tests: presenting measures of clinical validity and potential population impact in association studies.

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