A call for transparent reporting to optimize the predictive value of preclinical research

National Institute of Neurological Disorders and Stroke, NIH, Bethesda, Maryland 20892, USA.
Nature (Impact Factor: 42.35). 10/2012; 490(7419):187-91. DOI: 10.1038/nature11556
Source: PubMed

ABSTRACT The US National Institute of Neurological Disorders and Stroke convened major stakeholders in June 2012 to discuss how to improve the methodological reporting of animal studies in grant applications and publications. The main workshop recommendation is that at a minimum studies should report on sample-size estimation, whether and how animals were randomized, whether investigators were blind to the treatment, and the handling of data. We recognize that achieving a meaningful improvement in the quality of reporting will require a concerted effort by investigators, reviewers, funding agencies and journal editors. Requiring better reporting of animal studies will raise awareness of the importance of rigorous study design to accelerate scientific progress.

Download full-text


Available from: Oswald Steward, Jul 28, 2015
  • Source
    • "Similar suggestions have been made for biological studies (Kozlov and Hurlbert, 2006; Verbitsky, 2013) and research in sports medicine and sports science (Hayen, 2006). It was recently noted that when a biological variation in response to some intervention was the variable of interest in the analysis of samples, considering the natural grouping of objects was essential (Landis et al., 2012). Therefore, the current study has three main goals: (i) to determine gender differences in start reaction times for four different 50 m stroke final events at six Swimming World Championships, (ii) to assess the effects of ignoring natural groupings at Swimming World Championships, and (iii) to evaluate the effects of the large sample size on statistical inferences when gender differences are examined with respect to start reaction times among elite swimmers at Swimming World Championships. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Four 50 meter male/female finals ‐ the freestyle, butterfly, breaststroke, and backstroke ‐ swum during individual events at the Swimming World Championships (SWCs) can be defined in four clusters. The aim of the present study was to use a single‐unit design structure, in which the swimmer was defined at only one scale, to evaluate gender differences in start reaction times among elite swimmers in 50 m events. The top six male and female swimmers in the finals of four swimming stroke final events in six SWCs were analyzed. An unpaired t‐test was used. The p‐values were evaluated using Neo‐Fisherian significance assessments (Hurlbert and Lombardi, 2012). For the freestyle, gender differences in the start reaction times were positively identified for five of the six SWCs. For the backstroke, gender differences in the start reaction times could be dismissed for five of the six SWCs. For both the butterfly and breaststroke, gender differences in the start reaction times yielded inconsistent statistical differences. Pooling all swimmers together (df = 286) showed that an overall gender difference in the start reaction times could be positively identified: p = 0.00004. The contrast between the gender differences in start reaction times between the freestyle and backstroke may be associated with different types of gender adaptations to swimming performances. When the natural groupings of swimming stroke final events were ignored, sacrificial pseudoreplication occurred, which may lead to erroneous statistical differences.
    Journal of Human Kinetics 09/2014; 42(1):215‐222. DOI:10.2478/hukin‐2014‐0075 · 0.70 Impact Factor
  • Source
    • "To search the ZND, a researcher uses drop-down fields to select investigator and drugs of interest to experimental results and drug effects that are often presented as textual descriptions. Similarly, large-scale mouse phenotyping projects like the Mouse Phenome Database (MPD) at The Jackson Laboratory allow users to find, visualize and analyze mouse behavioral phenotypes across different strains and conditions (Maddatu et al., 2012). The MPD stores a large amount of standardized, quantifiable and comparable data (like weight and grip strength). "
    [Show abstract] [Hide abstract]
    ABSTRACT: Most neuroactive drugs were discovered through unexpected behavioral observations. Systematic behavioral screening is inefficient in most model organisms. But, automated technologies are enabling a new phase of discovery-based research in central nervous system (CNS) pharmacology. Researchers are using large-scale behavior-based chemical screens in zebrafish to discover compounds with new structures, targets, and functions. These compounds are powerful tools for understanding CNS signaling pathways. Substantial differences between human and zebrafish biology will make it difficult to translate these discoveries to clinical medicine. However, given the molecular genetic similarities between humans and zebrafish, it is likely that some of these compounds will have translational utility. We predict that the greatest new successes in CNS drug discovery will leverage many model systems, including in vitro assays, cells, rodents, and zebrafish.
    Frontiers in Pharmacology 07/2014; 5:153. DOI:10.3389/fphar.2014.00153 · 3.80 Impact Factor
  • Source
    • "The non mammalian studies had " probably high " risk of bias for the sequence generation, allocation concealment, and blinding domains. Because these components have been shown empirically to influence study outcomes in experimental animal studies (Bebarta et al. 2003; Landis et al. 2012; Macleod et al. 2004), our group consensus was to downgrade each non human body of evidence by one quality level (–1) for risk of bias across studies. "
    [Show abstract] [Hide abstract]
    ABSTRACT: Background: The Navigation Guide is a novel systematic review method to synthesize scientific evidence and reach strength of evidence conclusions for environmental health decision making. Objective: Our aim was to integrate scientific findings from human and nonhuman studies to determine the overall strength of evidence for the question “Does developmental exposure to perfluorooctanoic acid (PFOA) affect fetal growth in humans?” Methods: We developed and applied prespecified criteria to systematically and transparently a) rate the quality of the scientific evidence as “high,” “moderate,” or “low”; b) rate the strength of the human and nonhuman evidence separately as “sufficient,” “limited,” “moderate,” or “evidence of lack of toxicity”; and c) integrate the strength of the human and nonhuman evidence ratings into a strength of the evidence conclusion. Results: We identified 18 epidemiology studies and 21 animal toxicology studies relevant to our study question. We rated both the human and nonhuman mammalian evidence as “moderate” quality and “sufficient” strength. Integration of these evidence ratings produced a final strength of evidence rating in which review authors concluded that PFOA is “known to be toxic” to human reproduction and development based on sufficient evidence of decreased fetal growth in both human and nonhuman mammalian species. Conclusion: We concluded that developmental exposure to PFOA adversely affects human health based on sufficient evidence of decreased fetal growth in both human and nonhuman mammalian species. The results of this case study demonstrate the application of a systematic and transparent methodology, via the Navigation Guide, for reaching strength of evidence conclusions in environmental health. Citation: Lam J, Koustas E, Sutton P, Johnson PI, Atchley DS, Sen S, Robinson KA, Axelrad DA, Woodruff TJ. 2014. The Navigation Guide—evidence-based medicine meets environmental health: integration of animal and human evidence for PFOA effects on fetal growth. Environ Health Perspect 122:1040–1051;
    Environmental Health Perspectives 06/2014; 122(10). DOI:10.1289/ehp.1307923 · 7.03 Impact Factor
Show more