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Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines.

ABSTRACT: Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document aims to improve the utility of pharmacogenetic testing in routine clinical settings.

SUBMITTER: Kim S

PROVIDER: S-EPMC5204002 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

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Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines.

Kim Sollip S Yun Yeo Min YM Chae Hyo Jin HJ Cho Hyun Jung HJ Ji Misuk M Kim In Suk IS Wee Kyung A KA Lee Woochang W Song Sang Hoon SH Woo Hye In HI Lee Soo Youn SY Chun Sail S

Annals of laboratory medicine 20170301 2

Pharmacogenetic testing for clinical applications is steadily increasing. Correct and adequate use of pharmacogenetic tests is important to reduce unnecessary medical costs and adverse patient outcomes. This document contains recommended pharmacogenetic testing guidelines for clinical application, interpretation, and result reporting through a literature review and evidence-based expert opinions for the clinical pharmacogenetic testing covered by public medical insurance in Korea. This document ...[more]

PMID: 28029011

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Project description:BACKGROUND:This report presents updated National Academy of Clinical Biochemistry Laboratory Medicine Practice Guidelines summarizing quality requirements for the use of tumor markers. METHODS:One subcommittee developed guidelines for analytical quality relevant to serum and tissue-based tumor markers in current clinical practice. Two other subcommittees formulated recommendations particularly relevant to the developing technologies of microarrays and mass spectrometry. RESULTS:Prerequisites for optimal use of tumor markers in routine practice include formulation of the correct clinical questions to ensure selection of the appropriate test, adherence to good clinical and laboratory practices (e.g., minimization of the risk of incorrect patient and/or specimen identification, tube type, or timing), use of internationally standardized and well-characterized methods, careful adherence to manufacturer instructions, and proactive and timely reactions to information derived from both internal QC and proficiency-testing specimens. Highly desirable procedures include those designed to minimize the risk of the reporting of erroneous results attributable to interferences such as heterophilic antibodies or hook effects, to facilitate the provision of informative clinical reports (e.g., cumulative and/or graphical reports, appropriately derived reference intervals, and interpretative comments), and when possible to integrate these reports with other patient information through electronic health records. Also mandatory is extensive validation encompassing all stages of analysis before introduction of new technologies such as microarrays and mass spectrometry. Provision of high-quality tumor marker services is facilitated by dialogue involving researchers, diagnostic companies, clinical and laboratory users, and regulatory agencies. CONCLUSIONS:Implementation of these recommendations, adapted to local practice, should encourage optimization of the clinical use of tumor markers.

Project description:BackgroundClinical Practice Guidelines (CPGs) play an important role in clinical practice, and they require appropriate evaluation, especially in application. This study explores the application evaluation method of CPGs for Traditional Chinese Medicines (TCM). It uses the Analytic Hierarchy Process (AHP) and clinical cases to evaluate the consistency between CPGs of TCM and clinical practice.MethodsTo evaluate the consistency between CPGs of TCM and clinical cases, a 3-level AHP construction was built. Weightings were calculated by collecting questionnaires according to AHP theory. To test the evaluation system, a retrospective study was performed. The study evaluated the China Association of Chinese Medicine's Guidelines for Diagnosis and Treatment of Common Internal Diseases in Chinese Medicine Diseases of Modern Medicine (CPGs of DTCID) (ZYYXH/T50-135-2008). A total of 150 cases were involved. The evaluation system was used to assess the consistency between CPGs of DTCID and clinical cases of angina pectoris.ResultsThe results showed that the overall consistency between CPGs of DTCID and the 150 cases was 42.32 ± 6.94%, ranging from 35.21 to 63.37%. The overall consistency was not affected by age, gender, type of angina pectoris, condition of percutaneous coronary intervention (PCI), or angina classification as determined by the Canadian Cardiovascular Society. The consistencies of each index were as follows: Diagnosis of TCM, 100%; Diagnosis of Western medicine, 100%; Syndrome classification, 38.25 ± 4.40%; Syndrome key point, 34.17 ± 8.15%; TCM Decoction, 31.08 ± 23.64%; TCM particular treatment, 7.92 ± 19.13%; and Recuperation and prevention, 0. The most frequent syndromes were qi-deficiency, phlegm and blood stasis (n = 124) (82.7%). The overall consistency of qi-deficiency, turbid phlegm and blood stasis was lower than the overall consistency of the group without that syndrome. The difference was statistically significant (P < 0.05). 42 cases (28%) applied the TCM decoction recommended by CPGs of DTCID. Of these, Gualouxiebaibanxia decoction was applied in 34 cases. Wendan decoction, the most frequently used, was applied in 64 cases (42.7%).ConclusionThis study indicates that the AHP system can perform quantitative evaluation of consistency between TCM CPG and clinical practice. It also found the factors affecting the application of TCM CPGs and might indicate the need for revisions of CPGs.

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Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines.

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Clinical Pharmacogenetic Testing and Application: Laboratory Medicine Clinical Practice Guidelines.

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