The 10-D assessment and evidence-based medicine tool for authors and peer reviewers in clinical pharmacology

Abstract

Background: Peer reviewers and authors of clinical pharmacology manuscripts need to meet the standards for Evidence-Based Medicine (EBM) and Good Publication Practices (GPP), and editors of clinical pharmacology journals have to maintain an overview of the peer review process. Methods and results: The peer review process can be monitored and facilitated using the 10-D assessment, which comprises peer review criteria to determine if: 1. design of the study, 2. diagnoses employed, 3. drug molecules involved, 4. dosages applied, 5. data collected, 6. discussion of the findings, 7. deductions made, 8. documentation, 9. declarations, and 10. dHS (drug hypersensitivity syndrome) risk assessment is in accord with the objectives of the study and meet the requirements of EBM and GPP. Conclusions: The 10-D assessment tool, although easy to apply, requires a high level of clinical pharmacology expertise, especially in the fields of drug disposition, pharmacokinetics, and drug action. Its application will facilitate the peer review of clinical research and clinical trial reports and thus promote safety in drug development and pharmacotherapy and meet the needs of Good Publication Practices.

Pharmacovigilance of cutaneous adverse drug reactions in associations with drugs and medical conditions: a retrospective study of hospitalized patients

“…Our findings support the complex interplay between drugs and host factors. The risk of drug allergy is assessed by consideration of multiple factors [21][22][23][24]: 1) Drug factors: nature of the drug, dose, frequency, and duration of drug exposure, route of administration, and cross-sensitization; 2) Host factors: age, gender, genetic predisposition (e.g., human leukocyte antigen type and acetylation status), concomitant diseases (e.g., Epstein-Barr virus, human immunodeficiency virus, and asthma), past drug reactions, and multiple allergic syndromes. Despite lower incidence relative to non-severe CADRs, severe CADRs are potentially lifethreatening during the acute stage and associated with severe chronic sequelae, mortality, and high healthcare costs.…”

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“…Second, a recent article by Woodcock and Harder proposes the “10D assessment,” suggesting the following criteria should be fully described by authors publishing studies of clinical pharmacology that also apply to clinical PGx: 1. d esign of the study, 2. d iagnoses employed, 3. d rug molecules involved, 4. d osages applied, 5. d ata collected, 6. d iscussion of the findings, 7. d eductions made, 8. d ocumentation, 9. d eclarations, and 10. d HS (drug hypersensitivity syndrome) risk assessment (9). The article concludes that the assessment will help articles meet the standards for Evidence-Based Medicine (EBM) (10) and Good Publication Practices (GPP) (11).…”

“…Second, a recent article by Woodcock and Harder proposes the "10D assessment, " suggesting the following criteria should be fully described by authors publishing studies of clinical pharmacology that also apply to clinical PGx: (i) design of the study, (ii) diagnoses used, (iii) drug molecules involved, (iv) dosages applied, (v) data collected, (vi) discussion of the findings, (vii) deductions made, (viii) documentation, (ix) declarations, and (x) drug hypersensitivity syndrome risk assessment. 9 The article concludes that the assessment will help articles meet the standards for evidencebased medicine 10 and good publication practices. 11 Third, publications reporting PGx studies should follow the FAIR principles: the FAIR principles are a commitment to make data Findable, Accessible, Interoperable, and Reproducible (FAIR).…”

How publication guidelines for clinical pharmacology trials may help to accelerate knowledge transfer

“…However, both recommendations had not been developed within the CON-SORT framework and, more importantly, are not available as open access documents, which limits their value as guidelines for authors. Additionally, a "10-D assessment" has recently been proposed as a guidance for authors and reviewers [19], which combines both methodological aspects (such as "design," "dosage," or "data collected") as well topics specific in the field of clinical pharmacology (such as "drug molecule" or "drug hypersensitivity syndrome" [denoting risk assessment in the context of this guidance]).…”