STrengthening the Reporting Of Pharmacogenetic Studies: Development of the STROPS guideline


Autoři: Marty Chaplin aff001;  Jamie J. Kirkham aff001;  Kerry Dwan aff003;  Derek J. Sloan aff004;  Geraint Davies aff005;  Andrea L. Jorgensen aff001
Působiště autorů: Department of Biostatistics, University of Liverpool, Liverpool, United Kingdom aff001;  Centre for Biostatistics, Manchester Academic Health Science Centre, University of Manchester, Manchester, United Kingdom aff002;  Cochrane Editorial Unit, London, United Kingdom aff003;  School of Medicine, University of St Andrews, St Andrews, United Kingdom aff004;  Department of Clinical Infection, Microbiology and Immunology, University of Liverpool, Liverpool, United Kingdom aff005
Vyšlo v časopise: STrengthening the Reporting Of Pharmacogenetic Studies: Development of the STROPS guideline. PLoS Med 17(9): e32767. doi:10.1371/journal.pmed.1003344
Kategorie: Guidelines and Guidance
doi: 10.1371/journal.pmed.1003344

Souhrn

Background

Large sample sizes are often required to detect statistically significant associations between pharmacogenetic markers and treatment response. Meta-analysis may be performed to synthesize data from several studies, increasing sample size and, consequently, power to detect significant genetic effects. However, performing robust synthesis of data from pharmacogenetic studies is often challenging because of poor reporting of key data in study reports. There is currently no guideline for the reporting of pharmacogenetic studies that has been developed using a widely accepted robust methodology. The objective of this project was to develop the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline.

Methods and findings

We established a preliminary checklist of reporting items to be considered for inclusion in the guideline. We invited representatives of key stakeholder groups to participate in a 2-round Delphi survey. A total of 52 individuals participated in both rounds of the survey, scoring items with regards to their importance for inclusion in the STROPS guideline. We then held a consensus meeting, at which 8 individuals considered the results of the Delphi survey and voted on whether each item ought to be included in the final guideline. The STROPS guideline consists of 54 items and is accompanied by an explanation and elaboration document. The guideline contains items that are particularly important in the field of pharmacogenetics, such as the drug regimen of interest and whether adherence to treatment was accounted for in the conducted analyses. The guideline also requires that outcomes be clearly defined and justified, because in pharmacogenetic studies, there may be a greater number of possible outcomes than in other types of study (for example, disease–gene association studies). A limitation of this project is that our consensus meeting involved a small number of individuals, the majority of whom are based in the United Kingdom.

Conclusions

Our aim is for the STROPS guideline to improve the transparency of reporting of pharmacogenetic studies and also to facilitate the conduct of high-quality systematic reviews and meta-analyses. We encourage authors to adhere to the STROPS guideline when publishing pharmacogenetic studies.

Klíčová slova:

Drug research and development – Genetics – Metaanalysis – Research reporting guidelines – Surveys – Systematic reviews – Pharmacogenetics – Pharmacogenomics


Zdroje

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Článek vyšel v časopise

PLOS Medicine


2020 Číslo 9

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