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

English version

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: https://doi.org/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

1. Little J, Higgins J, editors. The HuGENet™ HuGE review handbook, version 1.0: Ottawa, Ontario, Canada: Department of Epidemiology and Community Medicine, Faculty of Medicine, University of Ottawa; 2006 [updated 23 October 2015; cited 2020 13 May]. Available from: http://www.medicine.uottawa.ca/public-health-genomics/web/assets/documents/HuGE_Review_Handbook_V1_0.pdf

2. Von Elm E, Altman DG, Egger M, Pocock SJ, Gøtzsche PC, Vandenbroucke JP. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) statement: guidelines for reporting observational studies. Ann Intern Med. 2007;147(8):573–577.

3. Little J, Higgins JP, Ioannidis JP, Moher D, Gagnon F, Von Elm E, et al. STrengthening the REporting of Genetic Association studies (STREGA): an extension of the STROBE statement. Hum Genet. 2009;125(2):131–151.

4. Richardson M, Kirkham JJ, Dwan KM, Sloan DJ, Davies G, Jorgensen A. Protocol for the development of the STrengthening the Reporting Of Pharmacogenetic Studies (STROPS) guideline: checklist of items for reporting pharmacogenetic studies. BMJ Open. 2019;9(7):e030212.

5. The EQUATOR Network. Equator Network. 2020 [cited 2020 April 9]. Available from: https://www.equator-network.org/.

6. Janssens AC, Ioannidis JP, van Duijn CM, Little J, Khoury MJ. Strengthening the reporting of Genetic RIsk Prediction Studies: the GRIPS Statement. PLoS Med. 2011;8(3):e1000420.

7. Jorgensen AL, Williamson PR. Methodological quality of pharmacogenetic studies: issues of concern. Stat Med. 2008;27(30):6547–6569.

8. SCImago. SJR—SCImago Journal & Country Rank. 2020 [cited 2020 April 9]. Available from: http://www.scimagojr.com.

9. Guyatt GH, Oxman AD, Kunz R, Atkins D, Brozek J, Vist G, et al. GRADE guidelines: 2. Framing the question and deciding on important outcomes. J Clin Epidemiol. 2011;64(4):395–400.

10. McDonagh E, Whirl‐Carrillo M, Altman R, Klein T. Enabling the curation of your pharmacogenetic study. Clin Pharmacol Ther. 2015;97(2):116–119.

11. Thorn CF, Whirl‐Carrillo M, Hachad H, Johnson JA, McDonagh EM, Ratain MJ, et al. Essential characteristics of pharmacogenomics study publications. Clin Pharmacol Ther. 2019;105(1):86–91.

12. Williamson PR, Altman DG, Blazeby JM, Clarke M, Devane D, Gargon E, et al. Developing core outcome sets for clinical trials: issues to consider. Trials. 2012;13(1):132.

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