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The study design elements employed by researchers in preclinical animal experiments from two research domains and implications for automation of systematic reviews.

ABSTRACT: Systematic reviews are increasingly using data from preclinical animal experiments in evidence networks. Further, there are ever-increasing efforts to automate aspects of the systematic review process. When assessing systematic bias and unit-of-analysis errors in preclinical experiments, it is critical to understand the study design elements employed by investigators. Such information can also inform prioritization of automation efforts that allow the identification of the most common issues. The aim of this study was to identify the design elements used by investigators in preclinical research in order to inform unique aspects of assessment of bias and error in preclinical research. Using 100 preclinical experiments each related to brain trauma and toxicology, we assessed design elements described by the investigators. We evaluated Methods and Materials sections of reports for descriptions of the following design elements: 1) use of comparison group, 2) unit of allocation of the interventions to study units, 3) arrangement of factors, 4) method of factor allocation to study units, 5) concealment of the factors during allocation and outcome assessment, 6) independence of study units, and 7) nature of factors. Many investigators reported using design elements that suggested the potential for unit-of-analysis errors, i.e., descriptions of repeated measurements of the outcome (94/200) and descriptions of potential for pseudo-replication (99/200). Use of complex factor arrangements was common, with 112 experiments using some form of factorial design (complete, incomplete or split-plot-like). In the toxicology dataset, 20 of the 100 experiments appeared to use a split-plot-like design, although no investigators used this term. The common use of repeated measures and factorial designs means understanding bias and error in preclinical experimental design might require greater expertise than simple parallel designs. Similarly, use of complex factor arrangements creates novel challenges for accurate automation of data extraction and bias and error assessment in preclinical experiments.

SUBMITTER: O'Connor AM

PROVIDER: S-EPMC6023607 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature

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The study design elements employed by researchers in preclinical animal experiments from two research domains and implications for automation of systematic reviews.

O'Connor Annette M AM Totton Sarah C SC Cullen Jonah N JN Ramezani Mahmood M Kalivarapu Vijay V Yuan Chaohui C Gilbert Stephen B SB Gilbert Stephen B SB

PloS one 20180628 6

Systematic reviews are increasingly using data from preclinical animal experiments in evidence networks. Further, there are ever-increasing efforts to automate aspects of the systematic review process. When assessing systematic bias and unit-of-analysis errors in preclinical experiments, it is critical to understand the study design elements employed by investigators. Such information can also inform prioritization of automation efforts that allow the identification of the most common issues. Th ...[more]

PMID: 29953471

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Project description:BackgroundSystematic reviews (SRs) are cornerstones of evidence-based medicine and have contributed significantly to breakthroughs since the 1980's. However, preclinical SRs remain relatively rare despite their many advantages. Since 2011 the Dutch health funding organisation (ZonMw) has run a grant scheme dedicated to promoting the training, coaching and conduct of preclinical SRs. Our study focuses on this funding scheme to investigate the relevance, effects and benefits of conducting preclinical SRs on researchers and their research.MethodsWe recruited researchers who attended funded preclinical SR workshops and who conducted, are still conducting, or prematurely stopped a SR with funded coaching. We gathered data using online questionnaires followed by semi-structured interviews. Both aimed to explore the impact of conducting a SR on researchers' subsequent work, attitudes, and views about their research field. Data-analysis was performed using Excel and ATLAS.ti.ResultsConducting preclinical SRs had two distinct types of impact. First, the researchers acquired new skills and insights, leading to a change in mindset regarding the quality of animal research. This was mainly seen in the way participants planned, conducted and reported their subsequent animal studies, which were more transparent and of a higher quality than their previous work. Second, participants were eager to share their newly acquired knowledge within their laboratories and to advocate for change within their research teams and fields of interest. In particular, they emphasised the need for preclinical SRs and improved experimental design within preclinical research, promoting these through education and published opinion papers.ConclusionBeing trained and coached in the conduct of preclinical SRs appears to be a contributing factor to many beneficial changes which will impact the quality of preclinical research in the long-term. Our findings suggest that this ZonMw funding scheme is helpful in improving the quality and transparency of preclinical research. Similar funding schemes should be encouraged, preferably by a broader group of funders or financers, in the future.

Project description:BackgroundMost school health education programs focus on a single behavioral domain. Integrative programs that address multiple behaviors may be more efficient, but only if the elements of change are similar for these behaviors. The objective of this study was to examine which effective elements of school health education are similar across three particular behavioral domains.MethodsA systematic review of reviews of the effectiveness of school-based health promotion programs was conducted for the domains of substance abuse, sexual behavior, and nutrition. The literature search spanned the time period between 1995 and October 2006 and included three databases, websites of review centers and backward search. Fifty-five reviews and meta-analyses met predetermined relevance and publication criteria and were included. Data was extracted by one reviewer and checked by a second reviewer. A standardized data extraction form was used, with detailed attention to effective elements pertaining to program goals, development, content, methods, facilitator, components and intensity. Two assessors rated the quality of reviews as strong, moderate or weak. We included only strong and moderate reviews in two types of analysis: one based on interpretation of conflicting results, the other on a specific vote-counting rule.ResultsThirty six reviews were rated strong, 6 moderate, and 13 weak. A multitude of effective elements was identified in the included reviews and many elements were similar for two or more domains. In both types of analysis, five elements with evidence from strong reviews were found to be similar for all three domains: use of theory; addressing social influences, especially social norms; addressing cognitive-behavioral skills; training of facilitators; and multiple components. Two additional elements had positive results in all domains with the rule-based method of analysis, but had inconclusive results in at least one domain with the interpretation-based method of analysis: parent involvement and a larger number of sessions.ConclusionFive effective elements of school health promotion were found to be similar across the three behavioral domains examined (substance abuse, sexual behavior, nutrition). An integrative program that addresses the three domains seems feasible. The five elements are primary candidates to include in programs targeting these behaviors.

Project description:BackgroundReducing the number of animals used in experiments has become a priority for the governments of many countries. For these reductions to occur, animal-free alternatives must be made more available and, crucially, must be embraced by researchers.MethodsWe conducted an international online survey for academics in the field of animal science (N?=?367) to explore researchers' attitudes towards the implementation of animal-free innovations. Through this survey, we address three key questions. The first question is whether scientists who use animals in their research consider governmental goals for animal-free innovations achievable and whether they would support such goals. Secondly, responders were asked to rank the importance of ten roadblocks that could hamper the implementation of animal-free innovations. Finally, responders were asked whether they would migrate (either themselves or their research) if increased animal research regulations in their country of residence restricted their research.ResultsWhile nearly half (40%) of the responders support governmental goals, the majority (71%) of researchers did not consider such goals achievable in their field within the near future. In terms of roadblocks for implementation of animal-free methods, ~?80% of the responders considered 'reliability' as important, making it the most highly ranked roadblock. However, all other roadblocks were reported by most responders as somewhat important, suggesting that they must also be considered when addressing animal-free innovations. Importantly, a majority reported that they would consider migration to another country in response to a restrictive animal research policy. Thus, governments must consider the risk of researchers migrating to other institutes, states or countries, leading to a 'brain-drain' if policies are too strict or suitable animal-free alternatives are not available.ConclusionOur findings suggest that development and implementation of animal-free innovations are hampered by multiple factors. We outline three pillars concerning education, governmental influence and data sharing, the implementation of which may help to overcome these roadblocks to animal-free innovations.

Project description:BackgroundOnly a small proportion of preclinical research (research performed in animal models prior to clinical trials in humans) translates into clinical benefit in humans. Possible reasons for the lack of translation of the results observed in preclinical research into human clinical benefit include the design, conduct, and reporting of preclinical studies. There is currently no formal domain-based assessment of the clinical relevance of preclinical research. To address this issue, we have developed a tool for the assessment of the clinical relevance of preclinical studies, with the intention of assessing the likelihood that therapeutic preclinical findings can be translated into improvement in the management of human diseases.MethodsWe searched the EQUATOR network for guidelines that describe the design, conduct, and reporting of preclinical research. We searched the references of these guidelines to identify further relevant publications and developed a set of domains and signalling questions. We then conducted a modified Delphi-consensus to refine and develop the tool. The Delphi panel members included specialists in evidence-based (preclinical) medicine specialists, methodologists, preclinical animal researchers, a veterinarian, and clinical researchers. A total of 20 Delphi-panel members completed the first round and 17 members from five countries completed all three rounds.ResultsThis tool has eight domains (construct validity, external validity, risk of bias, experimental design and data analysis plan, reproducibility and replicability of methods and results in the same model, research integrity, and research transparency) and a total of 28 signalling questions and provides a framework for researchers, journal editors, grant funders, and regulatory authorities to assess the potential clinical relevance of preclinical animal research.ConclusionWe have developed a tool to assess the clinical relevance of preclinical studies. This tool is currently being piloted.

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The study design elements employed by researchers in preclinical animal experiments from two research domains and implications for automation of systematic reviews.

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The study design elements employed by researchers in preclinical animal experiments from two research domains and implications for automation of systematic reviews.

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