The National Institutes of Health and Guidance for Reporting Preclinical Research David Moher1,2*, Marc Avey1, Gerd Antes3 and Douglas G Altman4,5
Total Page：16
File Type：pdf, Size：1020Kb
Moher et al. BMC Medicine (2015) 13:34 DOI 10.1186/s12916-015-0284-9 COMMENTARY Open Access The National Institutes of Health and guidance for reporting preclinical research David Moher1,2*, Marc Avey1, Gerd Antes3 and Douglas G Altman4,5 Abstract The quality of reporting clinical and preclinical research is not optimal. Reporting guidelines can help make reports of research more complete and transparent, thus increasing their value and making them more useful to all readers. Getting reporting guidelines into practice is complex and expensive, and involves several stakeholders, including prospective authors, peer reviewers, journal editors, guideline developers, and implementation scientists. Working together will help ensure their maximum uptake and penetration. We are all responsible for helping to ensure that all research is reported so completely that it is of value to everybody. Please see related article: http://dx.doi.org/10.1186/s12916-015-0266-y Keywords: Implementation, Preclinical research, Quality of reporting, Reporting guidelines Background as clinical, preclinical, and other characteristics, with at There is a large body of evidence indicating the very least another score in development [4]. The Network inadequate reporting of research, both clinical and pre- is working to harmonize these activities and has also clinical. For example, in a survey of highly cited (>500 published advice on how to develop reporting guide- citations) animal studies from seven leading journals lines[4],thushelpingtoensuretheirrigorousdevelop- by impact factor (Science, Nature, Cell, Nature Medi- ment and usefulness. One reason for their popularity is cine, Nature Genetics, Nature Immunology,andNature that, when used appropriately by prospective authors, Biotechnology) less than 20% of them described the ran- and endorsed and implemented optimally by journals, domization processes of the animals or blinding [1]. These they have their intended effect, namely, of improving the findings have been consistent across preclinical research completeness of research reports [5-7], thus increasing the content areas (e.g., [2,3]). value of research findings to clinicians, patients, and other To help increase the number of published papers that interested readers. are completely and transparently reported, and thus re- duce and/or eliminate the number of unusable publica- Recently published reporting guidelines tions, reporting guidelines have been developed since the Another reporting guideline – CoBRA, indicating how early 1990s. There has been a proliferation in their num- to optimally cite bioresources – has been published in bers, particularly in the last decade. Reporting guidelines BMC Medicine [8]. At least two other reporting guide- ’ are popular; the EQUATOR Networks library of reporting lines have been published this year already [9,10]. In guidelines indicates more than 200 in existence, cover- 2013, the National Institutes of Health entered the fray, ing a wide variety of designs, data, populations, as well supported by the Nature Publishing Group and Science magazine, and proposed the Principles and Guidelines * Correspondence: [email protected] for Reporting Preclinical Research (NIHPG) [11] with a 1Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa meeting involving 30 journal editors [12]. This triumvirate – Hospital General Campus, 501 Smyth Road, Room L1288, Ottawa, ON, is an important and influential group. The NIHPG include K1H 8L6, Canada 2Department of Epidemiology and Community Medicine, University of the better performance of statistical analysis, transparency Ottawa, Roger Guindon Hall, Room 3105, 451 Smyth Road, Ottawa, Ontario, in reporting, data and material sharing, consideration of K1H 8M5, Canada Full list of author information is available at the end of the article © 2015 Moher et al.; licensee BioMed Central. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Moher et al. BMC Medicine (2015) 13:34 Page 2 of 4 refutations, and consideration of establishing best practice possible they might be seen as confusing, particularly to guidelines, with a focus on authors providing complete prospective authors. For example, in journals that en- information about the methods used in their studies to dorse both ARRIVE (also endorsed by many journals – allow interested readers to replicate them. Within a [22]) and NIHPG, authors might not know whether to short period of time the NIHPG have been endorsed by use the NIHPG and/or ARRIVE and may elect to use an impressive, and growing, number of journals, such neither, thus negating the efforts of both groups (in areas as Blood, and groups, including the American Association of overlap, such as statistics, should authors choose one for Cancer Research and the World Association of guidance over another one and, if so, which one?). Indeed, Medical Editors [13]. a similar situation occurred during the developing of the CONSORT Statement for reporting randomized trials. Reporting preclinical research: how does NIHPG The CONSORT guidance was produced about 6 months compare with existing guidelines? before the Asilomar guidance. Dr. Drummond Rennie, In addition to the NIHPG, there are several other op- then deputy editor of JAMA, recommended the two tions [14-17] for prospective authors of preclinical re- groups work together to produce a single guidance thus search to report what they did and found, including the providing more clarity and direction for prospective Animal Research: Reporting of In Vivo Experiments authors. Similarly, the CONSORT group wanted to in- (ARRIVE) [18]. ARRIVE is a reporting guideline deve- corporate the TIDieR guidance for describing interven- loped in partnership with the National Centre for the tions [23] into the CONSORT checklist. Members of Replacement, Refinement and Reduction of Animals in both groups discussed how best to do this and provided Research [19]. The guidance was rigorously developed some guidance on this for prospective authors [23]. and followed a review of published animal studies that While the NIHPG guidance appears to have face valid- provided a rationale for moving forward. The develop- ity and support, a more pressing question is whether it ment process also included a consensus meeting with a will have its intended effect, namely, improving the com- broad spectrum of stakeholders interested in animal re- pleteness and transparency when reporting preclinical search. At its core, the ARRIVE guidance is a 20-item research, as well as facilitating the likelihood of repro- checklist covering what authors should report in the ducible studies being done. There is likely little merit in Introduction, Methods, Results, and Discussion sections editors asking authors to use the guidance – the inter- of their papers. For example, item 8 asks authors to re- vention – if it has only a minimal effect on relevant out- port on the experimental animals used: “Provide details comes such as better reporting and enabling others to of the animals used, including species, strain, sex, deve- adequately replicate methods. Unfortunately, an assess- lopmental stage (e.g. mean or median age plus age range) ment of the benefits (and harms) of reporting guidelines and weight”. There is evidence that authors are not pro- has not been a top priority of guideline developers [24], viding this information [20], despite it being essential if to date. We hope the NIHPG developers will actively others are interested in replication [21]. plan to conduct an evaluation of their guidance and en- The ARRIVE guidelines and NIHPG have different courage others to do likewise. Attention to relevant out- scope but similar objectives. The NIHPG is primarily fo- comes will be important to consider. Evaluations assessing cused on journal policy; for instance, the guidance rec- adherence to reporting guidelines (i.e., in addition to ommends that journals have either no or generous limits endorsement) may provide a more meaningful insight on the length of their methods sections. In contrast, the into its impact on completeness of reporting when used ARRIVE guidelines are focused on reporting within the at different stages of the editorial process. One such manuscript itself with its 20-item checklist, compared to recently performed evaluation [25] incorporated these the six ‘core’ reporting items found in the NIHPG. There concepts by comparing the use and non-use of reporting is little difference between the six proposed items and guidelines during peer review on author-revised manus- their corresponding items (sub-items) in the ARRIVE cript quality. checklist. Thus, the NIHPG items may be considered a Having produced the NIHPG – an intervention to minimum set of reporting items that are focused on the help improve the transparency and better reporting of internal validity and statistics of a paper, whereas the preclinical research – it is important to consider its ARRIVE guidelines are comprehensive and cover the en- endorsement and implementation. More generally, are tire paper from title to discussion. Indeed, the NIHPG journals using similar explicit language