Abstract
11 min readWest argues [[1]West R. Promoting greater transparency and accountability in clinical and behavioural research by routinely disclosing data and statistical commands.J Clin Epidemiol. 2015; ([Epub ahead of print])https://doi.org/10.1016/j.jclinepi.2015.06.015Abstract Full Text Full Text PDF Scopus (8) Google Scholar] that on an elective basis, journals could encourage authors of scientific publications to make data and statistical analysis command files available and get a "transparency" quality marker in reward. The concept is interesting, and the suggestion of data and code sharing is not new. Some journals have long made this a prerequisite for publication for some study types, for example, microarrays [[2]Ioannidis J.P. Allison D.B. Ball C.A. Coulibaly I. Cui X. Culhane A.C. et al.Repeatability of published microarray gene expression analyses.Nat Genet. 2009; 41: 149-155Crossref PubMed Scopus (415) Google Scholar]. Across the scientific literature, the proportion of journals that adopt sharing data and code policies is increasing [3Alsheikh-Ali A.A. Qureshi W. Al-Mallah M.H. Ioannidis J.P. Public availability of published research data in high-impact journals.PLoS One. 2011; 6: e24357Crossref PubMed Scopus (235) Google Scholar, 4Stodden V. Guo P. Ma Z. Toward reproducible computational research: an empirical analysis of data and code policy adoption by journals.PLoS One. 2013; 8: e67111Crossref PubMed Scopus (144) Google Scholar], although these editorial policies are not strongly enforced [[3]Alsheikh-Ali A.A. Qureshi W. Al-Mallah M.H. Ioannidis J.P. Public availability of published research data in high-impact journals.PLoS One. 2011; 6: e24357Crossref PubMed Scopus (235) Google Scholar]. The Center for Open Science (COS) has a process where it attributes to articles any of the three following rewarding "badges" [[5]Center for Open Science, Open Science Framework: Badges to acknowledge open practices. Available at https://osf.io/tvyxz/wiki/home/. Accessed December 24, 2014.Google Scholar]: open data, open materials, and preregistered. What West proposes is practically equivalent to the open data badge, which requires the following two prerequisites to be awarded [[5]Center for Open Science, Open Science Framework: Badges to acknowledge open practices. Available at https://osf.io/tvyxz/wiki/home/. Accessed December 24, 2014.Google Scholar]:1.Digitally shareable data are publicly available on an open-access repository (eg, university repository or one at www.re3data.org or www.databib.org).2.A codebook is included with sufficient description for an independent researcher to reproduce the reported analyses and results. Data from the same project that are not needed to reproduce the reported results can be kept private without losing eligibility for the open data badge. Assuming data and code do become available, an obvious question arises: Now what? What are we going to do with them? West [[1]West R. Promoting greater transparency and accountability in clinical and behavioural research by routinely disclosing data and statistical commands.J Clin Epidemiol. 2015; ([Epub ahead of print])https://doi.org/10.1016/j.jclinepi.2015.06.015Abstract Full Text Full Text PDF Scopus (8) Google Scholar] offers two potential uses: checking for and correcting errors and performing additional analyses to improve interpretation and identify new findings. Although I value these possibilities, it is important to probe empirically how fruitful they are likely to be. First, errors in data and computations are likely to be very common, probably almost ubiquitous in any scientific project that has any volume of work behind it [[6]Dewald W.G. Thursby J.G. Anderson R.G. Replication in empirical economics. The Journal of Money, Credit and Banking Project.Am Econ Rev. 1986; 76: 587-603Google Scholar]. Some of these errors are easily suspected even from the published reports [7Garcia-Berthou E. Alcaraz C. Incongruence between test statistics and P values in medical papers.BMC Med Res Methodol. 2004; 4: 13Crossref PubMed Scopus (126) Google Scholar, 8Bakker M. Wicherts J.M. The (mis)reporting of statistical results in psychology journals.Behav Res Methods. 2011; 44: 666-678Crossref Scopus (226) Google Scholar]. The question is how frequently errors are big enough to make a profound difference in the inferences and conclusions of a article. We have more limited evidence to answer this question. The frequency of such errors may increase with the complexity of data set and analytical issues and the lack of expertise of the researchers. However, researchers who take the step to share their raw data and analysis codes in public are likely to be among the most sophisticated and most sensitized to error issues. They are also likely to take extra steps to check that what they submit in public squares with what they report in the article, so as to avoid major embarrassments. These extra steps may require some extra resources and effort spent on preparing the publicly viewable versions of the data [[9]Khokhar R.H. Chen R. Fung B.C. Lui S.M. Quantifying the costs and benefits of privacy-preserving health data publishing.J Biomed Inform. 2014; 50: 107-121Abstract Full Text Full Text PDF PubMed Scopus (39) Google Scholar] because data are often used in chaotic formats [[10]Doshi P. Jefferson T. Del Mar C. The imperative to share clinical study reports: recommendations from the Tamiflu experience.Plos Med. 2012; 9: e1001201Crossref PubMed Scopus (142) Google Scholar]. Even then, some errors would be unavoidable. In that case, the paradox may arise that the most meticulous and sophisticated and method-savvy and careful researchers may become more susceptible to criticism and reputation attacks by reanalyzers who hunt for errors, no matter how negligible these errors are. This means that we need to find ways to incentivize researchers to share but also avoid unnecessary aggressiveness or defensiveness when shared data and code have errors or do not get replicated [[11]Bohannon J. Replication effort provokes praise—and 'bullying' charges.Science. 2014; 344: 788-789Crossref PubMed Scopus (49) Google Scholar]. In a new paradigm of openness, we should accept that error is ubiquitous, as opposed to the dominant current paradigm where reviewers cannot find essential flaws in most articles simply because they have no means to really check the work that was done. It is not surprising that most peer reviews focus on conceptual and philosophical issues, presentation aesthetics (eg, how to best present tables or figures), or grammar and syntax rather than the core of the science, with some exceptions [[12]Hopewell S. Collins G.S. Boutron I. Yu L.M. Cook J. Shanyinde M. et al.Impact of peer review on reports of randomised trials published in open peer review journals: retrospective before and after study.BMJ. 2014; 349: g4145Crossref PubMed Scopus (70) Google Scholar]. Another disturbing corollary is that, if the only request to get an open data badge is the availability of data and code, there is absolutely no guarantee that what is deposited reflects what really was done. Often a multitude of analyses are conducted, and only the "best" results or products of "double-dipping" are written up for publication [13Kriegeskorte N. Simmons W.K. Bellgowan P.S.F. Baker C.I. Circular analysis in systems neuroscience: the dangers of double dipping.Nat Neurosci. 2009; 12: 535-540Crossref PubMed Scopus (1984) Google Scholar, 14Dwan K. Altman D.G. Clarke M. Gamble C. Higgins J.P. Sterne J.A. et al.Evidence for the selective reporting of analyses and discrepancies in clinical trials: a systematic review of cohort studies of clinical trials.Plos Med. 2014; 11: e1001666Crossref PubMed Scopus (136) Google Scholar, 15Ioannidis J.P. Why most discovered true associations are inflated.Epidemiology. 2008; 19: 640-648Crossref PubMed Scopus (947) Google Scholar]. "Best" could mean most-significant largest effects (and thus probably grossly inflated [[15]Ioannidis J.P. Why most discovered true associations are inflated.Epidemiology. 2008; 19: 640-648Crossref PubMed Scopus (947) Google Scholar]), or most congruent with whatever bias is held by the researcher, sponsor, or other stakeholders involved [[16]Ioannidis J.P. How to make more published research true.Plos Med. 2014; 11: e1001747Crossref PubMed Scopus (521) Google Scholar]. In this case, awarding an open data badge sadly makes the situation more misleading because it can masquerade as a marker of quality, although the presented analyses may represent the extreme of selection bias processes. The notion that open availability of data and code will allow the performance of more analyses that may change the interpretation of the original findings and offer new insights has merit but is also fraught with some difficulties. These analyses add to the multiplicity burden. When data become widely available, in theory, millions of scientists could now use them in billions of different ways, leading to lower poststudy odds of derived significant results [[17]Ioannidis J.P. Why most published research findings are false.Plos Med. 2005; 2: e124Crossref PubMed Scopus (6250) Google Scholar]. Moreover, these analyses may add multiplicity that is mostly nontransparent, if most of these scientists do not disclose all their attempts to find something that would change the interpretation of the original findings. The credibility of such analyses may be pretty low. West identifies [[1]West R. Promoting greater transparency and accountability in clinical and behavioural research by routinely disclosing data and statistical commands.J Clin Epidemiol. 2015; ([Epub ahead of print])https://doi.org/10.1016/j.jclinepi.2015.06.015Abstract Full Text Full Text PDF Scopus (8) Google Scholar] conditions that would make the credibility suffer even further, such as analyses by authors with vested interests and those with poor analytical credentials. One hopes that with maximized transparency, transparency rules would apply also to these additional analyses. Unfortunately, currently scientists are incentivized to claim new discoveries so as to publish and get funded. It is thus not surprising that when reanalyses of raw data are performed, even for randomized trials and even for the same hypothesis as in the original article, in 35% of the cases, the conclusions change about whether patients should be treated or not and which patients should be treated [[18]Ebrahim S. Sohani Z.N. Montoya L. Agarwal A. Thorlund K. Mills E.J. et al.Reanalyses of randomized clinical trial data.JAMA. 2014; 312: 1024-1032Crossref PubMed Scopus (139) Google Scholar]. Interestingly, authors from the original articles almost always coauthor these reanalyses that lead to different interpretations. This reinterpretation challenge is likely to become even greater with wider availability of raw data, unless the incentive structure changes and reward are given for getting high-quality results rather than "new," "significant," and "different" results. Another important potential use of raw data is not in performing additional analyses using just the same data set, but in integrating raw data from multiple similar data sets. The advantages and caveats of such meta-analyses using raw data are beyond the scope of this commentary. However, when raw data are available from only a small subset of the relevant studies, perhaps a biased subset, there can be major disadvantages compared with a more comprehensive meta-analysis of group-level data. In all, I think that data that have been collected and code that has been written and implemented with effort and with expenditure of resources are worthwhile saving for further use—by default. However, the way these tools are going to be used and the interpretation of such uses need careful consideration. More sophisticated approaches are currently available that allow capturing every step in the design, conduct, and implementation of a study and its computational analyses. For example, the entire design and computational process may be summarized in a barcode that can then be re-expanded to show all the steps that were taken [[19]Gavish M. Donoho D. A universal identifier for computational results.Procedia Comput Sci. 2011; 4: 637-647Crossref Scopus (31) Google Scholar], including the false leads, the hidden multiplicity of dead-end analyses, and all the persistent plain errors that remain to be discovered by future reanalysts. Such detailed disclosure and documentation would make most sense in the setting where it is coupled with some sort of study pre-registration [[20]Nosek B.A. Lakens D. Registered reports.Soc Psychol. 2014; 45: 137-141Crossref Scopus (435) Google Scholar]. Preregistration is one of the three badges mentioned previously, and to get one, the following criteria must be met [[5]Center for Open Science, Open Science Framework: Badges to acknowledge open practices. Available at https://osf.io/tvyxz/wiki/home/. Accessed December 24, 2014.Google Scholar]:1.A public date-time stamped registration is in an institutional registration system (eg, ClinicalTrials.gov, open science Framework)2.Registration predates realization of the outcomes3.Registered design and analysis plan corresponds directly to reported design and analysis4.Full disclosure of results following the registered plan Although I believe that preregistration and full documentation is a good idea, it probably applies only to a fraction of conducted research. Much research is and should continue to be exploratory. It would be misleading to try to make exploratory research seem more preconceived than it really is. Scientists should be allowed to ponder ideas and analyze data in nonpredetermined, unexpected, and unconventional ways, provided that they also fully acknowledge that this is exactly what they have done. Softwares that track their tortuous process through exploratory ideas and analyses may be useful for being able to back track what was done, but the exact role of such back tracking remains to be determined. Eventually, one should specify what exactly worked, if any, among zillions of performed exploratory analyses, so that independent hypothesis-validating studies could test the very same analytical sequence for validation. However, we should not create an artificial environment where investigators are incentivized to seemingly preregister studies that are not really preconceived, simply because carrying a "preregistered" badge carries value. Although it may sound simple, creating the optimal research environment that fosters disclosing what we did and what we found and sharing the evidence is not straightforward. Data and statistical commands should be routinely disclosed in order to promote greater transparency and accountability in clinical and behavioral researchJournal of Clinical EpidemiologyVol. 70PreviewThis commentary argues for clinical, public health, and health science journals routinely to invite authors to make data and statistical analysis command files underlying the findings reported in articles available as supplementary files and signal prominently articles for which this is done using a "transparency" quality marker. Full-Text PDF
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