1. STrengthening the Reporting Of Pharmacogenetic Studies: Development of the STROPS guideline
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Marty Chaplin, Jamie J. Kirkham, Kerry Dwan, Derek J. Sloan, Geraint Davies, Andrea L. Jorgensen, Irma Aguilar-Delfín, José A G Agúndez, Sophie M Argon, M J Arranz, Derrick A Bennett, Stefan Böhringer, Lawrence Brody, Ingolf Cascorbi, Erika Cecchin, Mandy Crommentuijn-van Rhenen, Ann K Daly, Nur Aizati Athirah Daud, Jorge Duconge, Chiara Fabbri, Alison Fitches, Andrea Gaedigk, Donato Gemmati, Claudia Maria Dan Hawcutt, Rachel Huddart, Evelyne Jacqz-Aigrain, Slobodan M Janković, Theodora Katsila, Gideon Koren, Beata S Lipska-Ziętkiewicz, Thomas Liehr, A H Maitland-van der Zee, Lisanne E N Manson, Martin H Maurer, Juan Eduardo Megías-Vericat, Taichi Ochi, Daniel J O'Connor, Laura B Ramsey, Gad Rennert, Francesco Rucci, Gaetano Santulli, Aris Saoulidis, Rashmi R Shah, Alessandro Serretti, Andrew Somogyi, Gere Sunder-Plassmann, Virginia Boso-Ribelles, Caroline F Thorn, Evangelia Eirini Tsermpini, Satyanarayana Chakradhara Rao Uppugunduri, Michael A van Es, Magdalena Zarowiecki, University of St Andrews. School of Medicine, University of St Andrews. Infection and Global Health Division, Chaplin, Marty, Kirkham, Jamie J., Dwan, Kerry, Sloan, Derek J., Davies, Geraint, Jorgensen, Andrea L., Aguilar-Delfín, Irma, G Agúndez, José A, M Argon, Sophie, J Arranz, M, A Bennett, Derrick, Böhringer, Stefan, Brody, Lawrence, Cascorbi, Ingolf, Cecchin, Erika, Crommentuijn-van Rhenen, Mandy, K Daly, Ann, Aizati Athirah Daud, Nur, Duconge, Jorge, Fabbri, Chiara, Fitches, Alison, Gaedigk, Andrea, Gemmati, Donato, Maria Dan Hawcutt, Claudia, Huddart, Rachel, Jacqz-Aigrain, Evelyne, M Janković, Slobodan, Katsila, Theodora, Koren, Gideon, S Lipska-Ziętkiewicz, Beata, Liehr, Thoma, H Maitland-van der Zee, A, N Manson, Lisanne E, H Maurer, Martin, Eduardo Megías-Vericat, Juan, Ochi, Taichi, J O'Connor, Daniel, B Ramsey, Laura, Rennert, Gad, Rucci, Francesco, Santulli, Gaetano, Saoulidis, Ari, R Shah, Rashmi, Serretti, Alessandro, Somogyi, Andrew, Sunder-Plassmann, Gere, Boso-Ribelles, Virginia, F Thorn, Caroline, Eirini Tsermpini, Evangelia, Chakradhara Rao Uppugunduri, Satyanarayana, A van Es, Michael, and Zarowiecki, Magdalena
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Male ,Delphi Technique ,Delphi method ,Surveys ,030204 cardiovascular system & hematology ,Guidelines and Guidance ,Mathematical and Statistical Techniques ,0302 clinical medicine ,Surveys and Questionnaires ,Medicine and Health Sciences ,030212 general & internal medicine ,Statistics ,Politics ,Stakeholder ,Genomics ,General Medicine ,Research Assessment ,Metaanalysis ,Middle Aged ,Checklist ,Systematic review ,Research Design ,Physical Sciences ,Research Reporting Guidelines ,Medicine ,Engineering and Technology ,Female ,Goals ,Biotechnology ,Adult ,RM ,medicine.medical_specialty ,Drug Research and Development ,Consensus ,Systematic Reviews ,MEDLINE ,Bioengineering ,Research and Analysis Methods ,03 medical and health sciences ,Genomic Medicine ,Stakeholder Participation ,Genetics ,medicine ,Humans ,Statistical Methods ,Genetic Association Studies ,Pharmacology ,Publishing ,Survey Research ,business.industry ,Biology and Life Sciences ,DAS ,Guideline ,United Kingdom ,RM Therapeutics. Pharmacology ,Pharmacogenomic Testing ,Pharmacogenetics ,Sample size determination ,Family medicine ,Pharmacogenomics ,business ,Mathematics - Abstract
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., Marty Chaplin and co-authors recount the development of a guideline for reporting pharmacogenetic studies.
- Published
- 2020
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