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Promises and challenges of pharmacogenetics: an overview of study design, methodological and statistical issues.

ABSTRACT: Pharmacogenetics is the study of inherited variation in drug response. The goal of pharmacogenetics is to develop novel ways of maximizing drug efficacy and minimizing toxicity for individual patients. Personalized medicine has the potential to allow for a patient's genetic information to predict optimal dosage for a drug with a narrow therapeutic index, to select the most appropriate pharmacological agent for a given patient and to develop cost-effective treatments. Although there is supporting evidence in favour of pharmacogenetics, its adoption in clinical practice has been slow because of sometimes conflicting findings among studies. This failure to replicate findings may result from a lack of high-quality pharmacogenetic studies, as well as unresolved methodological and statistical issues. The objective of this review is to discuss the benefits of incorporating pharmacogenetics into clinical practice. We will also address outstanding methodological and statistical issues that may lead to heterogeneity among reported pharmacogenetic studies and how they may be addressed.

SUBMITTER: Ross S

PROVIDER: S-EPMC3738322 | biostudies-literature | 2012 Apr

REPOSITORIES: biostudies-literature

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Promises and challenges of pharmacogenetics: an overview of study design, methodological and statistical issues.

Ross Stephanie S Anand Sonia S SS Joseph Philip P Paré Guillaume G

JRSM cardiovascular disease 20120405 1

Pharmacogenetics is the study of inherited variation in drug response. The goal of pharmacogenetics is to develop novel ways of maximizing drug efficacy and minimizing toxicity for individual patients. Personalized medicine has the potential to allow for a patient's genetic information to predict optimal dosage for a drug with a narrow therapeutic index, to select the most appropriate pharmacological agent for a given patient and to develop cost-effective treatments. Although there is supporting ...[more]

PMID: 24175062

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Project description:To assess the feasibility and acceptability of training stroke service staff to provide supported communication for people with moderate-severe aphasia in the acute phase; assess the suitability of outcome measures; collect data to inform sample size and Health Economic evaluation in a definitive trial.Phase II cluster-controlled, observer-blinded feasibility study.In-patient stroke rehabilitation units in the UK matched for bed numbers and staffing were assigned to control and intervention conditions.70 stroke rehabilitation staff from all professional groups, excluding doctors, were recruited. 20 patients with moderate-severe aphasia were recruited.Supported communication for aphasia training, adapted to the stroke unit context versus usual care. Training was supplemented by a staff learning log, refresher sessions and provision of communication resources.Feasibility of recruitment and acceptability of the intervention and of measures required to assess outcomes and Health Economic evaluation in a definitive trial. Staff outcomes: Measure of Support in Conversation; patient outcomes: Stroke and Aphasia Quality of Life Scale; Communicative Access Measure for Stroke; Therapy Outcome Measures for aphasia; EQ-5D-3L was used to assess health outcomes.Feasibility of staff recruitment was demonstrated. Training in the intervention was carried out with 28 staff and was found to be acceptable in qualitative reports. 20 patients consented to take part, 6 withdrew. 18 underwent all measures at baseline; 16 at discharge; and 14 at 6-month follow-up. Of 175 patients screened 71% were deemed to be ineligible, either lacking capacity or too unwell to participate. Poor completion rates impacted on assessment of patient outcomes. We were able to collect sufficient data at baseline, discharge and follow-up for economic evaluation.The feasibility study informed components of the intervention and implementation in day-to-day practice. Modifications to the design are needed before a definitive cluster-randomised trial can be undertaken.ISRCTN37002304; Results.

Project description:BackgroundWe aimed to provide a comprehensive overview of methodological challenges in economic evaluations of disease prevention and health promotion (DPHP)-measures.MethodsWe conducted an overview of reviews searching MEDLINE, EMBASE, NHS Economic Evaluation Database, Database of Promoting Health Effectiveness Reviews, Cochrane Database of Systematic Reviews (CDSR) and Database of Promoting Health Effectiveness Reviews (DOPHER) (from their inception to October 2021). We included both systematic and scoping reviews of economic evaluations in DPHP addressing following methodological aspects: (i) attribution of effects, (ii) outcomes, (iii) inter-sectoral (accruing to non-health sectors of society) costs and consequences and (iv) equity. Data were extracted according to the associated sub-criteria of the four methodological aspects including study design economic evaluation (e.g. model-based), type/scope of the outcomes (e.g. outcomes beyond health), perspective, cost categories related to non-health sectors of society, and consideration of equity (method of inclusion). Two reviewers independently screened all citations, full-text articles, and extracted data. A narrative synthesis without a meta-analysis or other statistical synthesis methods was conducted.ResultsThe reviewing process resulted in ten systematic and one scoping review summarizing 494 health economic evaluations. A lifelong time horizon was adopted in about 23% of DPHP evaluations, while 64% of trial-based evaluations had a time horizon up to 2 years. Preference-based outcomes (36%) and non-health outcomes (8%) were only applied in a minority of studies. Although the inclusion of inter-sectoral costs (i.e. costs accruing to non-health sectors of society) has increased in recent years, these were often neglected (between 6 and 23% depending on the cost category). Consideration to equity was barely given in economic evaluations, and only addressed in six of the eleven reviews.ConclusionsEconomic evaluations of DPHP measures give only little attention to the specific methodological challenges related to this area. For future economic DPHP evaluations a tool with structured guidance should be developed. This overview of reviews was not registered and a published protocol does not exist.

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Promises and challenges of pharmacogenetics: an overview of study design, methodological and statistical issues.

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Promises and challenges of pharmacogenetics: an overview of study design, methodological and statistical issues.

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