Methodology
Our methodology
Below are the core principles we try to follow. This might change over time as we steelman the techniques but we had to start somewhere.
- Use structured reasons and arguments (Dutilh Novaes & Zalta, 2021; Walton, 1988).
- If possible, use arguments based on evidence (Kelly & Zalta, 2016), science (Hepburn et al., 2021), and rationalism (Markie et al., 2021).
- Use a hierarchy of evidence (Schünemann et al., 2022) that generally values certain types of evidence higher than others in the following order:
- Experimental studies (Franklin et al., 2021) by experts in peer-reviewed, scientific journals
- Meta-analyses, systematic reviews (Lasserson et al., 2022) and umbrella reviews (Ioannidis, 2009) of the following types of studies:
- Randomized controlled trial (RCT) experiments (Reiss et al., 2022; Kendall, 2003): Patients are randomly assigned to an intervention group or a control group (not receiving the intervention) and the groups are compared, hopefully controlling for confounding variables (Lu, 2009):
- Placebo-controlled: A placebo is assumed to have no or minimal effect
- Non-placebo-controlled
- Versions of the above two types:
- Quadruple blinded (patient, experimenters, data analyst, and care givers)
- Triple blinded (patient, experimenters, and data analyst)
- Double blinded (patient and experimenters)
- Single blinded (patient)
- Unblinded
- Experiments without a control group
- Experiments on groups
- Experiments on individuals (case studies)
- Experiments exploring a mechanism of action (Craver et al., 2019)
- Correlational/observational studies by experts in peer-reviewed, scientific journals
- Meta-analyses, systematic reviews, and umbrella reviews of the following types of studies:
- Cohort studies (Euser et al., 2009): Follow one exposed group and a non-exposed group (control) and compare outcomes.
- Prospective: Baseline is assessed and then researchers actively follow patients to perform a follow-up: More accurate data collection
- Retrospective: Historical analysis of existing data
- Case-control studies (Lu, 2009): Follow one group with an outcome and another without an outcome (control) and compare exposure.
- Cross-sectional studies (Lu, 2009): Analyze whether individuals were exposed and whether they had certain outcomes and compare to those that didn’t (control).
- Observations without a control group
- Observations of groups
- Observations of individuals (case studies)
- Ecological studies (Lu, 2009): Similar to cross-sectional studies but groups are analyzed instead of individuals
- Simulated model (Frigg et al., 2020) results by experts in peer-reviewed, scientific journals
- Opinions by experts in peer-reviewed, scientific journals
- Groups of experts
- Individual experts
- All of the above but not in peer-reviewed, scientific journals
- All of the above but not by experts
- Experimental studies (Franklin et al., 2021) by experts in peer-reviewed, scientific journals
- Use a burden of proof
Causation and Correlation
Most arguments pre-suppose some theory of causation (Gallow, 2022) where one or more things happening are necessary, sufficient, and/or contribute to one or more other things happening.
A related concept is correlation where one or more things happening may be associated, with some probability, with one or more other things happening.
However, it’s possible for things to be highly correlated but causally unrelated which is called a spurious correlation (Aldrich, 1995), thus leading to the common warning that “correlation does not [necessarily] imply causation”. This has been known since the late 19th century (Pearson, 1897).
Burden of Proof
A burden of proof is an expectation by one side about the strength of argument required by another side for persuasion. A burden of proof may be useful to establish the core of a debate and avoid an argument going on indefinitely (Walton, 1988b). A burden of proof may assert controversial philosophical or ethical premises, but we think this is still valuable in clarifying the context and exit criteria of an argument.
Caveats
Potential Issues with a hierarchy of evidence and evidence-based medicine
- There are potential issues with the concept of a hierarchy of evidence and the related “evidence-based medicine” (EBM) movement (Murad et al., 2016; Anglemyer et al., 2014; Frieden, 2017; Stegenga, 2018; Blunt, 2015; Jureidini & McHenry, 2022; Charlton, 2009; Charlton & Miles, 1998).
- A lack of evidence higher in the hierarchy is not necessarily problematic due to infeasibility (Smith & Pell, 2003; Prasad & Jena, 2013), unnecessary risks (Glasziou et al., 2007), ethical issues, etc., although there are risks to making such assumptions (Prasad et al., 2011; Prasad et al., 2013; Haslam et al., 2021; Herrera-Perez et al., 2019; Rossouw et al., 2002; Powell & Prasad, 2022).
- In some cases, evidence lower in the hierarchy may be stronger; for example, a well-done experiment might be stronger than a poorly done RCT.
Potential Evidence Issues
- Successful results with small sample sizes but failures with large sample sizes (Hwang et al., 2016)
- Published results tend to be overly optimistic about effect sizes because of low power and selection on statistical significance (Ioannidis, 2008)
- Poor rates of replication (Errington et al., 2021, Open Science Collaboration, 2015)
- Incomplete or distorted reporting of results (BMJ, 2012, The Cochrane Collaboration, 2014)
- Poor incentives (Horton, 2015; Nosek et al., 2012)
- Ostensibly useful results that are instead likely due to noise or poor data quality, despite honesty and transparency (Gelman, 2017)
- Incomplete analysis of results (BMJ, 2012)
- Lack of awareness of problems and lack of analytical skills by medical professionals (Ioannidis et al., 2017)
- Poor evidence for either effectiveness or harm (Ioannidis, 2023)
- Statistically significant but false effects due to low statistical power (Button et al., 2013)
- Lacking or poor reproduction, or too much reproduction (Ioannidis & Trikalinos, 2007)
- Non-random sampling (Carlisle, 2017)
- Difficulties analyzing data with multilevel structure (Gelman & Brown, 2024)
- Misinterpretation of the literature (Gelman & Brown, 2024)
- High heterogeneity violating random-effects model assumptions (Stanley et al., 2022) and creating invalid generalizations (Bryan et al., 2021)
- Poor external validity (Reiss et al., 2022)
- Incorrect statistical controls (Westfall & Yarkoni, 2016)
- Medical reversals (Prasad & Cifu, 2012)
- Mistakes (e.g. data entry, variable coding, statistics, over-interpretation, etc.) (Gelman, 2017; Brown & Heathers, 2017)
- Multiple comparisons (Bennett et al., 2009)
- p-hacking, researcher degrees of freedom, multiple potential comparisons, or fishing expeditions (Wasserstein & Lazar, 2016; Wasserstein et al., 2019; Simmons et al., 2016; Humphreys et al., 2013; Gelman & Loken, 2013)
- Misconduct and fraud (Fanelli, 2009; Smith, 2021; Crocker, 2011; Van Noorden, 2022; Adam, 2019; Fang et al., 2012; Thacker, 2021)
- Conflicts of interest and funding distortions (Lexchin et al., 2003; Lundh et al., 2010; Angell, 2009)
- Likelihood of objectivity (whether conscious or subconscious) of researchers (Angell, 2009b)
- Likelihood of objectivity (whether conscious or subconscious) of clinicians (Angell, 2009b)
- Likelihood of objectivity (whether conscious or subconscious) of organizations (Angell, 2009b)
- Poor instrument or method reliability (Vul et al., 2009)
- Limited post-publication critique (Hardwicke et al., 2022)
- Experimenter effects (Sorge et al., 2014; Schlitz et al., 2006)
- Publication selection bias (Bartos et al., 2022) and difficulty detecting it (Tang & Liu, 2000)
- Institutional inertia and politics (Rigas et al., 1999), etc.
- Peer review failures, biases, and gate keeping (Huber et al., 2022; Ferguson et al., 2014; Siler et al., 2015; Sackett, 2000)
- Low quality evidence (Howick et al., 2022)
- Under-reporting of harms (Howick et al., 2022)
- Poor data sharing and transparency (Hardwicke et al., 2022b; Gabelica et al., 2022; Gelman, 2017)
- Outcome switching (Altman et al., 2017)
- Failures of pre-registration (Brodeur et al., 2022)
- Incorrect sub-group analyses (Peto, 2011)
- Reporting biases (Weinerova et al., 2022)
- Lack of post-publication review (Gelman, 2017)
- Fake studies (Brainard, 2023, Van Noorden, 2023)
- Undisclosed financial incentives of public health authorities (Lenzer, 2015)
- High rates of retractions (Van Noorden, 2023b)
- Significant variation in analyses of complex subjective data, even by experts with honest intentions (Silberzahn et al., 2018)
- White hat bias (ends justifies the means or medical Machiavellianism) (Cope & Allison, 2010)
Potential Issues with Specific Methods
- Meta-analyses
- Study selection (Jørgensen et al., 2018)
- Transparency (Coyne et al., 2010)
- Poor quality (Ioannidis, 2016)
- Poor reproducibility (Bodnaruc et al., 2025)
- RCTs
- Simpson’s Paradox (Sprenger et al., 2021)
- Bias (Vinkers et al., 2021)
- Observational studies
- Equally justifiable but different ways of analyzing data, each of which may produce different results (Wang et al., 2024)
Expert Opinions
- Dr. Marcia Angell, physician and editor-in-chief of The New England Journal of Medicine (Angell, 2009)
It is simply no longer possible to believe much of the clinical research that is published, or to rely on the judgment of trusted physicians or authoritative medical guidelines. I take no pleasure in this conclusion, which I reached slowly and reluctantly over my two decades as an editor of The New England Journal of Medicine.
- Dr. Richard Horton, editor-in-chief of The Lancet (Horton, 2015)
The case against science is straightforward: much of the scientific literature, perhaps half, may simply be untrue. Afflicted by studies with small sample sizes, tiny effects, invalid exploratory analyses, and flagrant conflicts of interest, together with an obsession for pursuing fashionable trends of dubious importance, science has taken a turn towards darkness. […] Can bad scientific practices be fixed? Part of the problem is that no-one is incentivised to be right. […] Following several high-profile errors, the particle physics community now invests great effort into intensive checking and re-checking of data prior to publication. By filtering results through independent working groups, physicists are encouraged to criticise. Good criticism is rewarded. The goal is a reliable result, and the incentives for scientists are aligned around this goal. Weidberg worried we set the bar for results in biomedicine far too low. In particle physics, significance is set at 5 sigma—a p value of 3 × 10–7 or 1 in 3·5 million (if the result is not true, this is the probability that the data would have been as extreme as they are).
- Dr. John Ioannidis, Professor of Medicine, Epidemiology and Population Health, Statistics and Biomedical Data Science at Stanford (Freedman, 2010)
Science is a noble endeavor, but it’s also a low-yield endeavor. I’m not sure that more than a very small percentage of medical research is ever likely to lead to major improvements in clinical outcomes and quality of life. We should be very comfortable with that fact.
- Dr. Irving Langmuir, Nobel prize for Chemistry (Langmuir & Hall, 1989)
These are cases where there is no dishonesty involved but where people are tricked into false results by a lack of understanding about what human beings can do to themselves in the way of being led astray by subjective effects, wishful thinking or threshold interactions. These are examples of pathological science.
Potential Procedural Issues
- Meta-analyses
- Study selection (Jørgensen et al., 2018)
- Transparency (Coyne et al., 2010)
- Poor quality (Ioannidis, 2016)
- RCTs
- Simpson’s Paradox (Sprenger et al., 2021)
- Bias (Vinkers et al., 2021)
- Hierarchical/multilevel regression models
- Degenerate covariance matrix estimates that do not have a practical interpretation, commonly for multilevel models when data are noisy and the number of groups is small (Chung et al., 2015)
Other general points
- We use the heuristic that mistakes are generally made due to incompetence rather than malice (Bloch, 2003), although the latter is certainly possible.
- When comparing arguments, the number of points doesn’t necessarily matter. For example, a strong RCT or mechanistic study may outweigh dozens of alternative points.
References
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“Why aren’t all clinical trial data routinely available for independent scrutiny once a regulatory decision has been made? How have commercial companies been allowed to evaluate their own products and then to keep large and unknown amounts of the data secret even from the regulators? Why should it be up to the companies to decide who looks at the data and for what purpose? Why should it take legal action (as in the case of GlaxoSmithKline’s paroxetine and rosiglitazone), strong arm tactics by national licensing bodies (Pfizer’s reboxetine), and the exceptional tenacity of individual researchers and investigative journalists (Roche’s oseltamivir) to try to piece together the evidence on individual drugs? […] the Cochrane group has told the BMJ that about 60% of Roche’s data from phase III trials of oseltamivir have never been published. And although the European Medicines Agency (EMA) could have requested these data from Roche, it did not do so. This means that tax payers in the United Kingdom and around the world have spent billions of dollars stockpiling a drug for which no one except the manufacturer has seen the complete evidence base. Indeed the EMA’s unprecedented infringement proceedings launched against Roche last month suggest that even the manufacturer has never fully evaluated evidence it has collected on the drug’s adverse effects.”
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“P-values are a method of protecting researchers from declaring truth based on patterns in noise, and so it is ironic that, by way of data-dependent analyses, p-values are often used to lend credence to noisy claims based on small samples. To put it another way: without modern statistics, we find it unlikely that people would take seriously a claim about the general population of women, based on two survey questions asked to 100 volunteers on the internet and 24 college students. But with the p-value, a result can be declared significant and deemed worth publishing in a leading journal in psychology.”
“absent pre-registration, our data analysis choices will be data-dependent, even when they are motivated directly from theoretical concerns. When pre-registered replication is difficult or impossible (as in much research in social science and public health), we believe the best strategy is to move toward an analysis of all the data rather than a focus on a single comparison or small set of comparisons”
“In fields where new data can readily be gathered (such as in all four of the examples discussed above), perhaps the two-part structure of Nosek et al. (2013) will be a standard for future research. Instead of the current norm in which several different studies are performed, each with statistical significance but each with analyses that are contingent on data, perhaps researchers can perform half as many original experiments in each paper and just pair each new experiment with a pre-registered replication.”
Gelman, A., & Loken, E. (2013). The garden of forking paths: Why multiple comparisons can be a problem, even when there is no “fishing expedition” or “p-hacking” and the research hypothesis was posited ahead of time. Department of Statistics, Columbia University, 348, 1-17. https://stat.columbia.edu/~gelman/research/unpublished/forking.pdf
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Richard Smith was the editor of The BMJ until 2004.”
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“Since 2002, governments around the world have spent billions of dollars stockpiling neuraminidase inhibitors (NIs) such as Tamiflu® (oseltamivir) and Relenza® (zanamivir) in anticipation of an influenza pandemic. This trend increased dramatically following the outbreak of the H1N1 virus (swine flu) in April 2009. It was initially believed that NIs would reduce hospital admissions and complications of influenza, such as pneumonia, during influenza pandemics. However, the original evidence presented to government agencies around the world was incomplete, raising questions about the accuracy of these claims and the efficacy of both preparations. […] This latest Cochrane Review has benefited from access to more complete reports of the original research, now made available by the manufacturers, Roche and GlaxoSmithKline. Along with documenting evidence of harms from use of NIs, the review raises the question of whether global stockpiling of the drugs is still justifiable given the lack of reliable evidence to support the original claims of its benefits. […] Initially thought to reduce hospitalisations and serious complications from influenza, the review highlights that [NIs are] not proven to do this, and it also seems to lead to harmful effects that were not fully reported in the original publications. This shows the importance of ensuring that trial data are transparent and accessible.”
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“This description of reasoned dialogue as a process of deepened insight into one’s own position on a controversial issue is consistent with the Socratic view of dialogue as a means to attain self-knowledge. For Socrates, the process of learning was an ascent from the depths of the cave towards the clearer light of self-knowledge through the process of reasoned, and primarily verbal, dialogue with another discussant, on controversial issues. What Socrates emphasized as a most important benefit or gain of dialogue was self-knowledge. It was somehow through the process of articulation and testing of one’s best arguments against an able opponent in dialogue that real knowledge was to be gained.
This Socratic point of view draws our attention to the more hidden and subtle benefit of good, reasoned dialogue. Not only does it enable one to rationally persuade an opponent or co-participant in discussion, but it is also the vehicle that enables one to come to better understand one’s own position on important issues, one’s own reasoned basis behind one’s deeply held convictions. It is the concept of burden of proof that makes such shifts of rational persuasion possible, and thereby enables dialogue to contribute to knowledge.”
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“One of the most trenchant and fundamental criticisms of reasoned dialogue as a method of arriving at a conclusion is that argument on a controversial issue can go on and on, back and forth, without a decisive conclusion ever being determined by the argument. The only defence against this criticism lies in the use of the concept of the burden of proof within reasoned dialogue. Once a burden of proof is set externally, then it can be determined, after a finite number of moves in the dialogue, whether the burden has been met or not. Only by this device can we forestall an argument from going on indefinitely, and thereby arrive at a definite conclusion for or against the thesis at issue.”
Walton, D. N. (1988b). Burden of proof. Argumentation, 2(2), 233-254. DOI: 10.1007/BF00178024. https://doi.org/10.1007/BF00178024
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