title: Guidance on assessing the methodological and reporting quality of toxicologically relevant studies: A scoping review.
abstract: Assessments of methodological and reporting quality are critical to adequately judging the credibility of a study's conclusions and to gauging its potential reproducibility. To aid those seeking to assess the methodological or reporting quality of studies relevant to toxicology, we conducted a scoping review of the available guidance with respect to four types of studies: in vivo and in vitro, (quantitative) structure-activity relationships ([Q]SARs), physico-chemical, and human observational studies. Our aims were to identify the available guidance in this diverse literature, briefly summarize each document, and distill the common elements of these documents for each study type. In general, we found considerable guidance for in vivo and human studies, but only one paper addressed in vitro studies exclusively. The guidance for (Q)SAR studies and physico-chemical studies was scant but authoritative. There was substantial overlap across guidance documents in the proposed criteria for both methodological and reporting quality. Some guidance documents address toxicology research directly, whereas others address preclinical research generally or clinical research and therefore may not be fully applicable to the toxicology context without some translation. Another challenge is the degree to which assessments of methodological quality in toxicology should focus on risk of bias - as in clinical medicine and healthcare - or be broadened to include other quality measures, such as confirming the identity of test substances prior to exposure. Our review is intended primarily for those in toxicology and risk assessment seeking an entry point into the extensive and diverse literature on methodological and reporting quality applicable to their work.
authors.affiliation: Johns Hopkins Center for Alternatives to Animal Testing, 615 N. Wolfe St., Baltimore, MD 21205, USA. Electronic address: gsamuel4@jhu.edu.
authors.forename: Gbeminiyi O
authors.initials: GO
authors.lastname: Samuel
authors.affiliation: seh consulting + services, Stembergring 15, 33106 Paderborn, Germany. Electronic address: Sebastian.hoffmann@seh-cs.com.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Hoffmann
authors.affiliation: William H. Welch Medical Library, Johns Hopkins University, 2024 E. Monument St., Suite 1-200, Baltimore, MD 21287, USA. Electronic address: rwrigh32@jhmi.edu.
authors.forename: Robert A
authors.initials: RA
authors.lastname: Wright
authors.affiliation: The Ottawa Hospital, The Ottawa Hospital Research Institute, Ottawa, Ontario K1Y 4E9, Canada. Electronic address: manojlalu@gmail.com.
authors.forename: Manoj Mathew
authors.initials: MM
authors.lastname: Lalu
authors.affiliation: DuPont Haskell Global Centers, 1090 Elkton Rd., Newark, DE 19711, USA. Electronic address: grace.y.tier@usa.dupont.com.
authors.forename: Grace
authors.initials: G
authors.lastname: Patlewicz
authors.affiliation: Science and Research Division, American Chemistry Council, 700 2nd St., NE, Washington, DC 20002, USA. Electronic address: rick_becker@americanchemistry.com.
authors.forename: Richard A
authors.initials: RA
authors.lastname: Becker
authors.affiliation: MB Research Labs, 1765 Wentz Rd., Spinnerstown, PA 18968, USA. Electronic address: degeorge@mbresearch.com.
authors.forename: George L
authors.initials: GL
authors.lastname: DeGeorge
authors.affiliation: The Ottawa Hospital, The Ottawa Hospital Research Institute, Ottawa, Ontario K1Y 4E9, Canada. Electronic address: dafergusson@ohri.ca.
authors.forename: Dean
authors.initials: D
authors.lastname: Fergusson
authors.affiliation: Johns Hopkins Center for Alternatives to Animal Testing, 615 N. Wolfe St., Baltimore, MD 21205, USA. Electronic address: thartun1@jhu.edu.
authors.forename: Thomas
authors.initials: T
authors.lastname: Hartung
authors.affiliation: ExxonMobil Biomedical Sciences, Inc., 1545 U.S. Highway 22 East, Room LA 350, Annandale, NJ 08801, USA. Electronic address: r.jeffrey.lewis@exxonmobil.com.
authors.forename: R Jeffrey
authors.initials: RJ
authors.lastname: Lewis
authors.affiliation: Johns Hopkins Center for Alternatives to Animal Testing, 615 N. Wolfe St., Baltimore, MD 21205, USA. Electronic address: msteph14@jhu.edu.
authors.forename: Martin L
authors.initials: ML
authors.lastname: Stephens
mesh_terms: D015982:Bias; D004781:Environmental Exposure; D004785:Environmental Pollutants / Q000633:toxicity*; D006801:Humans; D015203:Reproducibility of Results; D012107:Research Design
chemical_list: D004785:Environmental Pollutants
keywords: Methodological quality; Reporting quality; Risk of bias; Scoping review; Toxicity studies