Reporting Standards for Preclinical Studies of Stroke Therapy
2016; Lippincott Williams & Wilkins; Volume: 47; Issue: 10 Linguagem: Inglês
10.1161/strokeaha.116.013643
ISSN1524-4628
AutoresFarhaan Vahidy, Wolf-Rüdiger Schäbitz, Marc Fisher, Jaroslaw Aronowski,
Tópico(s)Cell Image Analysis Techniques
ResumoHomeStrokeVol. 47, No. 10Reporting Standards for Preclinical Studies of Stroke Therapy Free AccessEditorialPDF/EPUBAboutView PDFView EPUBSections ToolsAdd to favoritesDownload citationsTrack citationsPermissions ShareShare onFacebookTwitterLinked InMendeleyReddit Jump toFree AccessEditorialPDF/EPUBReporting Standards for Preclinical Studies of Stroke Therapy Farhaan Vahidy, MD, PhD, Wolf-Rüdiger Schäbitz, MD, Marc Fisher, MD and Jaroslaw Aronowski, MD, PhD Farhaan VahidyFarhaan Vahidy From the Department of Neurology, University of Texas Health Science Center at Houston (F.V., J.A.); Department of Neurology, Bethel-EvKB University of Munster (W.-R.S.); and Department of Neurology, Beth Israel Deaconess Medical Centers, Harvard Medical School (M.F.). , Wolf-Rüdiger SchäbitzWolf-Rüdiger Schäbitz From the Department of Neurology, University of Texas Health Science Center at Houston (F.V., J.A.); Department of Neurology, Bethel-EvKB University of Munster (W.-R.S.); and Department of Neurology, Beth Israel Deaconess Medical Centers, Harvard Medical School (M.F.). , Marc FisherMarc Fisher From the Department of Neurology, University of Texas Health Science Center at Houston (F.V., J.A.); Department of Neurology, Bethel-EvKB University of Munster (W.-R.S.); and Department of Neurology, Beth Israel Deaconess Medical Centers, Harvard Medical School (M.F.). and Jaroslaw AronowskiJaroslaw Aronowski From the Department of Neurology, University of Texas Health Science Center at Houston (F.V., J.A.); Department of Neurology, Bethel-EvKB University of Munster (W.-R.S.); and Department of Neurology, Beth Israel Deaconess Medical Centers, Harvard Medical School (M.F.). Originally published13 Sep 2016https://doi.org/10.1161/STROKEAHA.116.013643Stroke. 2016;47:2435–2438Other version(s) of this articleYou are viewing the most recent version of this article. Previous versions: January 1, 2016: Previous Version 1 The unmet need for development of new stroke therapies is enormous. Evidence generated from positive, null, or negative preclinical studies for various therapeutic agents is crucial to enhancing scientific progress. The scientific community shares a societal responsibility to practice and promote meticulous conduct and reporting of all experimental studies. A systematic survey conducted by the UK government–sponsored National Center for the Replacement, Refinement, and Reduction of Animals in Research (NC3Rs) reported that only 59% of biomedical animal studies stated the hypotheses and objectives, and ≤87% did not use randomization.1 This, in part, led to the development of the Animals in Research: Reporting In Vivo Experiments (ARRIVE) guidelines,2 modeled after the CONSORT (Consolidated Standards for Reporting Trials) statements.3The examples of lack of extrapolation of findings from preclinical studies to clinical trials are many in the arena of stroke therapeutic development, and several excellent analyses of these translational failures have been presented.4–7 A ubiquitous theme emerging out of these evaluations is the need to practice scientific rigor in the conduct and reporting of preclinical studies of stroke therapy. The US National Institute of Neurological Disorders and Stroke has therefore called for funding organizations and journals to provide investigators with clear guidelines for essential features of animal study design and reporting.8Stroke: A Journal of Cerebral Circulation is one of the leading peer-reviewed publications for reporting clinical and basic science investigations of various aspects of cerebral vascular disorders. The editorial leadership of Stroke is actively engaged in national and international efforts for upholding the highest standards of rigor and responsibility in reporting preclinical research and is cosignatory to a consensus statement of leading journals on biomedical research reproducibility.9 The journal has previously published special reports to summarize, emphasize, and communicate the crux of methodological and reporting issues.10,11To improve quality of preclinical studies, a relatively simple checklist requesting reporting of randomization procedures, blinding, a priori definition of inclusion and exclusion, and so on was implemented in 2011. This basic science checklist is currently part of the submission process, and the document is evaluated by editors and reviewers but has not been published so far. A recent analysis revealed that the checklist implementation has led to improvements in reporting of key characteristics of the overall scientific quality.12 However, relevant components of quality such as definition of inclusion and exclusion criteria, statement of randomization methods, allocation concealment, and reporting of postrandomization exclusion of animals have either not or just minimally improved over time. The Stroke editorial team has identified a long-term goal of further improvement of methodological quality of experimental studies published in the journal. Therefore, a modified checklist is being promulgated as a prerequisite for every publication involving animal treatment experiments submitted to Stroke (Table 1). This novel checklist will be incorporated as a web-based form to be completed during the online submission process and published as a complementary online supplement with every article. A more explanatory accompaniment to the checklist is also being furnished to facilitate interpretation, application, and reporting of necessary criteria (Table 2).Table 1. Checklist of Methodological and Reporting Aspects for Articles Submitted to Stroke Involving Preclinical ExperimentationMethodological and Reporting AspectsDescription of ProceduresExperimental groups and study timeline□ The experimental group(s) have been clearly defined in the article, including number of animals in each experimental arm of the study.□ An account of the control group is provided, and number of animals in the control group has been reported. If no controls were used, the rationale has been stated.□ An overall study timeline is provided.Inclusion and exclusion criteria□ A priori inclusion and exclusion criteria for tested animals were defined and have been reported in the article.Randomization□ Animals were randomly assigned to the experimental groups. If the work being submitted does not contain multiple experimental groups, or if random assignment was not used, adequate explanations have been provided.□ Type and methods of randomization have been described.□ Methods used for allocation concealment have been reported.Blinding□ Blinding procedures have been described with regard to masking of group/treatment assignment from the experimenter. The rationale for nonblinding of the experimenter has been provided, if such was not feasible.□ Blinding procedures have been described with regard to masking of group assignment during outcome assessment.Sample size and power calculations□ Formal sample size and power calculations were conducted based on a priori determined outcome(s) and treatment effect, and the data have been reported. OR A formal size assessment was not conducted and a rationale has been provided.Data reporting and statistical methods□ Number of animals in each group: randomized, tested, lost to follow-up, or died have been reported. If the experimentation involves repeated measurements, the number of animals assessed at each time point is provided, for all experimental groups.□ Baseline data on assessed outcome(s) for all experimental groups have been reported.□ Details on important adverse events and death of animals during the course of experimentation have been provided, for all experimental arms.□ Statistical methods used have been reported.□ Numeric data on outcomes have been provided in text, or in a tabular format with the main article or as supplementary tables, in addition to the figures.Experimental details, ethics, and funding statements□ Details on experimentation including stroke model, formulation and dosage of therapeutic agent, site and route of administration, use of anesthesia and analgesia, temperature control during experimentation, and postprocedural monitoring have been described.□ Different sex animals have been used. If not, the reason/justification is provided.□ Statements on approval by ethics boards and ethical conduct of studies have been provided.□ Statements on funding and conflicts of interests have been provided.Table 2. Explanatory Accompaniment to the Checklist for Reporting Design and Methodological Features of Studies Involving Experimental Models of StrokeExperimental DesignExperimental groups and study timelineA clear definition of experimental groups would entail reporting the total number of groups in which animals were divided, along with the treatment, placebo/vehicle, or no-treatment used for each intervention. Different iterations of the intervention (eg, doses and time points of administration) are to be described as well.Controls groups may either be placebo concurrent, no-treatment concurrent, active-treatment concurrent, or dose/timing comparison concurrent. This needs to be clearly stated. The number of animals in each group is also to be reported. It is required that investigators use a concurrent control for each intervention group. Using singular control data across several experiments conducted over a course of time is similar to using historical controls in clinical research—a practice that does not hold its merit in evaluation of evidence for clinical trials.13A timeline of experimentation (ie, duration/period for completion of each experimental phase) is desirable. The objective is to inform whether all animals within each experimental group were analyzed together or were they composite of more than one experiment conducted at different time. It is possible that certain experiments take long time to complete; however, the inclusion of animals and experimental phases need to be concurrent. Timeline may include experimental phases such as: animal selection, randomization, intervention, and follow-up, for each experimental and control arm. If multiple interventions are being reported, please clearly state if the interventions are concurrent or a collection of experiments over a longer period of time. Authors are encouraged to provide a schematic or graphical representation of the timeline with either the main article or as supplementary material.Inclusion and exclusion criteriaA priori defined criteria to include and exclude animals for experimentation are to be determined and described. These may be various parameters like animals' species, sex, strain, weight, developmental state, source nomenclature, genotype, drug, or test naive, and so on. Any criteria used after induction of ischemic or hemorrhagic lesion for inclusion/exclusion (eg, baseline deficit) should also be reported.RandomizationRandomization is considered the gold standard for studies intended to test hypotheses. The use of randomization for assignment of animals to control or experimental groups is required to be reported. Certain studies such as those with only a single arm (intervention only) or those with exploratory or mechanistic aims may not use randomization. Authors are requested to provide clear explanations of such exceptions.The type and methods used to randomize animals to various study arms are to be reported clearly.a. Type of randomization, for example, simple or stratified is to be stated. If stratified, please describe which variables/factors were used for randomization and why. It is also recommended that investigators report measures of successful randomization, by providing baseline characteristics of animals in various comparison groups.b. Process of randomization: please provide details of the process used for randomization. These may include (but are not limited to) use of electronically generated lists, sealed envelopes, coin toss, dice roll, etc.c. Other procedural details of randomization include describing the independence of team members generating randomization sequences, performing randomization and group allocation, and conducting experimentation.Allocation concealment is an important aspect of randomization.14 If the study team member(s) performing randomization have knowledge of treatment assignment groups before selection of animals, then the allocation is not concealed, and a selection bias can be introduced. Allocation concealment can be achieved if deidentified codes are generated and provided to team members performing randomization. This usually entails an independent team member producing randomization sequences and lists. The journal encourages use and reporting of such procedures.BlindingBlinding or masking refers to:a. Inability of the investigator administrating the study intervention to discern treatment from the placebo/vehicle. This can be achieved by providing the investigator with animals having codes for group allocation, as well as study drug/product and placebo using a concealment procedure. The journal strongly recommends using and reporting blinding procedures in administration of treatment/placebo, wherever possible. For experimentation that in itself is surgical in nature, masking of the investigator performing study intervention may not be possible. We encourage appropriately reporting these aspects in the article.b. Besides the masking of intervention, it is also important that all outcomes be assessed in a blinded manner. Although blinding the investigator administering the treatment may not be possible in all instances, blinded assessment of behavioral and histological outcomes is almost universally possible. This is achieved by an effective tracking mechanism for the experimental animals and independence of the study team member performing outcome ascertainment from administration of the study intervention. The contributors to the journal are expected to provide an account of the experimental phases that were blinded to various investigator(s) and the steps undertaken to maintain blinding while transitioning from one experimental phase to the other.Sample size and power calculationsThe contributors to Stroke are encouraged to include an explanation of power and sample size calculations for experimentation involving formal hypothesis testing. Rationale for purported effect size of the intervention on a priori determined primary outcome(s) should be presented, along with the anticipated parameter of variability. The sources that form the bases of power and sample size calculations should be cited. We do recognize the exploratory nature of certain experiments where a formal power and sample size calculation may not be possible or meaningful. These exploratory analyses should be recognized as such, and the authors are encouraged to present befitting interpretations of these analyses, along with an explanation of why power calculations were not formally performed.Data reporting and statistical methodsNumbers of animals included in experiments and analyzed: For comprehensive reporting on number of animals in intervention and control groups, consider using a flow diagram showing: number of animals available for randomization, number of animals randomized to various treatment/control groups, number of animals for which baseline data were collected, number of animals included in the intervention, number of animals on whom follow-up/outcomes were assessed, and any animals that were lost at any stage during the experimental process.Baseline data: For each experimental group, report-relevant characteristics of animals and baseline data on measured functional and behavioral outcomes. This may include animal characteristics such as age, developmental stage, sex, species, genetic strain, comorbidities, and baseline deficit.Adverse events/deaths: Please provide details on all important adverse events including death in all experimental groups. If none, please state so.Statistical methods: Authors are required to provide details of statistical methods used for each analysis and hypothesis tested. Descriptive analyses should use use of measures of central tendency and spread suitable to the distribution of the data. Measures of spread (eg, SD or SE) should be suitably used, reported, and interpreted.15 Report levels of significance used for hypothesis testing and if any adjustments were done for multiple or repeated testing.Reporting results: Investigators are encouraged to report summary data as tables (ie, not limit data to figures). Figures in themselves, at times, do not allow for precise reporting of measures of central tendency and spread for different time points. Space limitations can be overcome by providing tabulated results in supplementary materials.Experimental details,ethics, and funding statementsIt is important to provide as many experimental details as possible and necessary for interpretation, comparison, and possible replication of the intervention. These details include (but are not limited to) stroke model, formulation, and dosage of therapeutic agent, site and route of administration, use of anesthesia and analgesia, temperature control during experimentation, and postprocedural monitoring. Further details on primary and secondary outcomes, the timeline for their assessment, and methods used for ascertainment of outcomes should also be provided or clearly referenced.The importance of using sex-specific models is well documented.16 Although the use of both sexes is not required, the authors are requested to give due consideration to the use of animals with both sexes during experimentation. Assuming only males or females are used, reasons need to be provided in the article.The journal requires all studies reporting animal experimentation to abide by respective institutional animal welfare and ethics regulations and reporting of approvals.Funding and conflict of interest statements should also be provided. The funding of the study by a drug development or technology development industry should be clearly stated.Although a collective effort for scientific rigor in all facets of preclinical and clinical stroke research is required for successful translation, we hereby provide important metrics for the conduct and reporting of preclinical treatment studies related to cerebral vascular pathologies. We also recognize that certain standards communicated above may not apply to exploratory, hypothesis-generating, or mechanistic animal models. We promote and welcome such contributions, however, encourage the authors to address various areas and describe why adherence to particular design elements was not practical or meaningful. These guidelines are complementary to the Journal's earlier communications and other cited literature. The recommendations provided herewith are intended to facilitate the Journal's overall mission of promoting robust scientific inquiry and experimentation, along with clearly communicating the desired standards to contributors and investigators. We encourage all facets of exploratory and confirmatory preclinical research and recognize that a large number of investigators adhere to robust experimental guidelines, however, such may not be clearly reported. We promote the use of online supplements for providing detailed protocols on experimentation and communicating any secondary results not reported in the published article.DisclosuresDrs Schäbitz, Fisher, and Aronowski are Editors of Stroke. The other author reports no conflicts.FootnotesThe opinions expressed in this article are not necessarily those of the editors or of the American Heart Association.Correspondence to Jaroslaw Aronowski, MD, PhD, Department of Neurology University of Texas–Houston Medical School, Houston, TX 77030. 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October 2016Vol 47, Issue 10 Advertisement Article InformationMetrics © 2016 American Heart Association, Inc.https://doi.org/10.1161/STROKEAHA.116.013643PMID: 27625385 Originally publishedSeptember 13, 2016 Keywordsanimal researchconsensuschecklistEditorialscerebrovascular circulationbiomedical researchPDF download Advertisement SubjectsQuality and Outcomes
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