The usage of Randomised Evaluations(REs) in social inquiry has been recent and responses to them have been wide ranging.RE seek to make predictions on the impact of an intervention, when it is attempted in a new situation. REs work by first determining the impact of the intervention. Subsequently, for the new situation it is expected that the impact would be similar. -/- The problem of induction poses one of the most serious challenges to the epistemological status of RE claims as (...) the value of REs themselve stem from their predictive validity. If the problem of induction is not solved or evaded then belief in projections based on REs is undermined. -/- In this paper, I argue that the unique methodology of REs used in Social Sciences allows itself to evade the problem the successfully, warranting belief that future interventions would have similar impact. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a novel antiviral medicine aimed (...) at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

Objective: To examine the current ethical review process of ethics committees in a non-pharmacological trial from the perspective of a clinical investigator.Design: Prospective collection of data at the Study Centre of the German Surgical Society on the duration, costs and administrative effort of the ERP of a randomised controlled multicentre surgical INSECT Trial between November 2003 and May 2005.Setting: Germany.Participants: 18 ethics committees, including the ethics committee handling the primary approval, responsible overall for 32 clinical sites throughout Germany. 8 ethics (...) committees were located at university medical schools and 10 at medical chambers. Duration was measured as days between submission and receipt of final approval, costs in euros and administrative effort by calculation of the product of the total number of different types of documents and the mean number of copies required .Results: The duration of the ERP ranged from 1 to 176 days. The median duration was 26 days at MSUs compared with 34 days at medical chambers. The total cost was €2947. 1 of 8 ethics committees at universities and 8 of 10 at medical chambers charged a median fee of €162 . The administrative effort for primary approval was 30. Four ethics committees required a higher administrative effort for secondary approval .Conclusion: The ERP for non-pharmacological multicentre trials in Germany needs improvement. The administrative process has to be standardised: the application forms and the number and content of the documents required should be identical or at least similar. The fees charged vary considerably and are obviously too high for committees located at medical chambers. However, the duration of the ERP was, with some exceptions, excellent. A centralised ethics committee in Germany for multicentre trials such as the INSECT Trial can simplify the ERP for clinical investigators in and outside the country. (shrink)

Objectives. The purpose of this study was to conduct the first randomized controlled trial (RCT) to evaluate the effectiveness of a second-generation mindfulness-based intervention (SG-MBI) for treating fibromyalgia syndrome (FMS). Compared to first generation mindfulness-based interventions, SG-MBIs are more acknowledging of the spiritual aspect of mindfulness. Design. A RCT employing intent-to-treat analysis. Methods. Adults with FMS received an 8-week SG-MBI known as meditation awareness training (MAT; n = 74) or an active control intervention known as cognitive behaviour theory for groups (...) (n = 74). Assessments were performed at pre-, post-, and 6-month follow-up phases. Results. Meditation awareness training participants demonstrated significant and sustained improvements over control group participants in FMS symptomatology, pain perception, sleep quality, psychological distress, non-attachment (to self, symptoms, and environment), and civic engagement. A mediation analysis found that (1) civic engagement partially mediated treatment effects for all outcome variables, (2) non-attachment partially mediated treatment effects for psychological distress and sleep quality, and (3) non-attachment almost fully mediated treatment effects for FMS symptomatology and pain perception. Average daily time spent in meditation was found to be a significant predictor of changes in all outcome variables. Conclusions. Meditation awareness training may be a suitable treatment for adults with FMS and appears to ameliorate FMS symptomatology and pain perception by reducing attachment to self. (shrink)

Randomization procedures are used in legal and statistical applications, aiming to shield important decisions from spurious influences. This article gives an intuitive introduction to randomization and examines some intended consequences of its use related to truthful statistical inference and fair legal judgment. This article also presents an open-code Java implementation for a cryptographically secure, statistically reliable, transparent, traceable, and fully auditable randomization tool.

Decoupling is a general principle that allows us to separate simple components in a complex system. In statistics, decoupling is often expressed as independence, no association, or zero covariance relations. These relations are sharp statistical hypotheses, that can be tested using the FBST - Full Bayesian Significance Test. Decoupling relations can also be introduced by some techniques of Design of Statistical Experiments, DSEs, like randomization. This article discusses the concepts of decoupling, randomization and sparsely connected statistical models in the epistemological (...) framework of cognitive constructivism. (shrink)

Randomization is an integral part of well-designed statistical trials, and is also a required procedure in legal systems. Implementation of honest, unbiased, understandable, secure, traceable, auditable and collusion resistant randomization procedures is a mater of great legal, social and political importance. Given the juridical and social importance of randomization, it is important to develop procedures in full compliance with the following desiderata: (a) Statistical soundness and computational efficiency; (b) Procedural, cryptographical and computational security; (c) Complete auditability and traceability; (d) Any (...) attempt by participating parties or coalitions to spuriously influence the procedure should be either unsuccessful or be detected; (e) Open-source programming; (f) Multiple hardware platform and operating system implementation; (g) User friendliness and transparency; (h) Flexibility and adaptability for the needs and requirements of multiple application areas (like, for example, clinical trials, selection of jury or judges in legal proceedings, and draft lotteries). This paper presents a simple and easy to implement randomization protocol that assures, in a formal mathematical setting, full compliance to the aforementioned desiderata for randomization procedures. (shrink)

t Intentional sampling methods are non-randomized procedures that select a group of individuals for a sample with the purpose of meeting specific prescribed criteria. In this paper we extend previous works related to intentional sampling, and address the problem of sequential allocation for clinical trials with few patients. Roughly speaking, patients are enrolled sequentially, according to the order in which they start the treatment at the clinic or hospital. The allocation problem consists in assigning each new patient to one, and (...) only one, of the alternative treatment arms. The main requisite is that the profiles in the alternative arms remain similar with respect to some relevant patients’ attributes (age, gender, disease, symptom severity and others). We perform numerical experiments based on a real case study and discuss how to conveniently set up perturbation parameters, in order to yield a suitable balance between optimality – the similarity among the relative frequencies of patients in the several categories for both arms, and decoupling – the absence of a tendency to allocate each pair of patients consistently to the same arm. (shrink)

Governments are increasingly using randomized controlled trials (RCTs) to evaluate policy interventions. RCTs are often understood to provide the highest quality evidence regarding the causal efficacy of an intervention. While randomization plays an essential epistemic role in the context of policy RCTs however, it also plays an important distributive role. By randomly assigning participants to either the intervention or control arm of an RCT, people are subject to different policies and so, often, to different types and levels of benefits. In (...) this paper, I identify one necessary condition as well as a set of sufficient conditions for the permissible use of random assignment by government agencies. I argue first that random assignment is permissible only if it is consistent with governments’ duty to realize morally important outcomes. I argue second that random assignment is permissible in cases where investigators are in a state of genuine equipoise regarding all arms of the experiment and the policy to which people have a claim of justice. Finally, I defend a set of conditions under which random assignment is permissible in cases where one or more arms of a policy RCT are reasonably expected to be either superior or inferior to this policy. (shrink)

Government agencies and nonprofit organizations have increasingly turned to randomized controlled trials (RCTs) to evaluate public policy interventions. Random assignment is widely understood to be fair when there is equipoise; however, some scholars and practitioners argue that random assignment is also permissible when an intervention is reasonably expected to be superior to other trial arms. For example, some argue that random assignment to such an intervention is fair when the intervention is scarce, for it is sometimes fair to use a (...) lottery to allocate scarce goods. We investigate the permissibility of randomization in public policy RCTs when there is no equipoise, identifying two sets of conditions under which it is fair to allocate access to a superior intervention via random assignment. We also reject oft-made claims that alternative study designs, including stepped-wedge designs and uneven randomization, offer fair ways to allocate beneficial interventions. (shrink)

There are two competing views regarding the role of mechanistic knowledge in inferences about the effectiveness of interventions. One view holds that inferences about the effectiveness of interventions should be based only on data from population-level studies (often statistical evidence from randomised trials). The other view holds that such inferences must be based in part on mechanistic evidence. The competing views are local principles of inference, the plausibility of which can be assessed by a more general normative principle of inference. (...) Bayesianism tells us to base inferences on both the ‘likelihood’ and the ‘prior’. The likelihood represents statistical evidence. One influence on the prior probability of a hypothesis like ‘d causes x’ is mechanistic knowledge of how d causes x. Thus, reasoning about such inferences by appealing to both statistical and mechanistic evidence is vindicated by our best general theory of inference. The primary contribution of this paper is to assess the merits and weaknesses of the arguments on both sides of the debate, using the Bayesian framework. This analysis lends support to those who argue that we should base our causal inferences about interventions in part on mechanistic evidence. (shrink)

According to manipulationist accounts of causal explanation, to explain an event is to show how it could be changed by intervening on its cause. The relevant change must be a ‘serious possibility’ claims Woodward 2003, distinct from mere logical or physical possibility—approximating something I call ‘scientific possibility’. This idea creates significant difficulties: background knowledge is necessary for judgments of possibility. Yet the primary vehicles of explanation in manipulationism are ‘invariant’ generalisations, and these are not well adapted to encoding such knowledge, (...) especially in the social sciences, as some of it is non-causal. Ceteris paribus (CP) laws or generalisations labour under no such difficulty. A survey of research methods such as case and comparative studies, randomised control trials, ethnography, and structural equation modeling, suggests that it would be more difficult and in some instances impossible to try to represent the output of each method in invariant generalisations; and that this is because in each method causal and non-causal background knowledge mesh in a way that cannot easily be accounted for in manipulationist terms. Ceteris paribus-generalisations being superior in this regard, a theory of explanation based on the latter is a better fit for social science. (shrink)

Experimental design is one aspect of a scientific method. A well-designed, properly conducted experiment aims to control variables in order to isolate and manipulate causal effects and thereby maximize internal validity, support causal inferences, and guarantee reliable results. Traditionally employed in the natural sciences, experimental design has become an important part of research in the social and behavioral sciences. Experimental methods are also endorsed as the most reliable guides to policy effectiveness. Through a discussion of some of the central concepts (...) associated with experimental design, including controlled variation and randomization, this chapter will provide a summary of key ethical issues that tend to arise in experimental contexts. In addition, by exploring assumptions about the nature of causation and by analyzing features of causal relationships, systems, and inferences in social contexts, this chapter will summarize the ways in which experimental design can undermine the integrity of not only social and behavioral research but policies implemented on the basis of such research. (shrink)

Evidence based-policy (EBP) is a popular research paradigm in the applied social sciences and within government agencies. Informally, EBP represents an explicit commitment to applying scientific methods to public affairs, in contrast to ideologically-driven or merely intuitive “common-sense” approaches to public policy. More specifically, the EBP paradigm places great weight on the results of experimental research designs, especially randomised controlled trials (RCTs), and systematic literature reviews that place evidential weight on experimental results. One hope is that such research designs and (...) approaches to analysing the scientific literature are sufficiently robust that they can settle what really ‘works’ in public policy. Can EBP succeed in displacing reliance on domain-specific expertise? On our account, this is seldom, if ever, the case. The key reason for this is that underlying this approach is generally an appeal to argument by induction, which always requires further assumptions to underwrite its validity, and if not induction, some other argument form that also requires assumptions that are very often not validated for the case at hand. (shrink)

ABSTRACT: Abstract Most modern knowledge is not science. The physical sciences have successfully validated theories to infer they can be used universally to predict in previously unexperienced circumstances. According to the conventional conception of science such inferences are falsified by a single irregular outcome. And verification is by the scientific method which requires strict regularity of outcome and establishes cause and effect. -/- Medicine, medical research and many “soft” sciences are concerned with individual people in complex heterogeneous populations. These populations (...) cannot be tested to demonstrate strict regularity of outcome in every individual. Neither randomised controlled trials nor observational studies in medicine are science in the conventional conception. Establishing and using medical and other “soft science” theories cannot be scientific. It requires conceptually different means: requiring expert judgement applying all available evidence in the relevant available factual matrix. -/- The practice of medicine is observational. Prediction of outcomes for the individual requires professional expertise applying available medical knowledge and evidence. Expertise in any profession can only be acquired through experience. Prior cases are the fundament of knowledge and expertise in medicine. Case histories, studies and series can provide knowledge of extremely high reliability applicable to establishing reliable general theories and falsifying others. Their collation, study and analysis should be a priority in medicine. Their devaluation as evidence, the failure to apply their lessons, the devaluation of expert professional judgement and the attempt to emulate the scientific method are all historic errors in the theory and practice of modern medicine. (shrink)

We simulate trial data to test speculative claims about research methods, such as the impact of publication bias.

I will open the first part of this paper by trying to elucidate the frequentist foundations of RCTs. I will then present a number of methodological objections against the viability of these inferential principles in the conduct of actual clinical trials. In the following section, I will explore the main ethical issues in frequentist trials, namely those related to randomisation and the use of stopping rules. In the final section of the first part, I will analyse why RCTs were (...) accepted for regulatory purposes. I contend that their main virtue, from a regulatory viewpoint, is their impartiality, which is grounded in randomisation and fixed rules for the interpretation of the experiment. Thus the question will be whether Bayesian trials can match or exceed the achievements of frequentist RCTs in all these respects. In the second part of the paper, I will first present a quick glimpse of the introduction of Bayesianism in the field of medical experiments, followed by a summary presentation of the basic tenets of a Bayesian trial. The point here is to show that there is no such thing as “a” Bayesian trial. Bayesianism can ground many different approaches to medical experiments and we should assess their respective virtues separately. Thus I present two actual trials, planned with different goals in mind, and assess their respective epistemic, ethical and regulatory merits. In a tentative conclusion, I contend that, given the constraints imposed by our current regulatory framework, impartiality should preside over the design of clinical trials, even at the expense of many of their inferential and ethical virtues. (shrink)

This thesis examines philosophical controversies surrounding the evaluation of medical treatments, with a focus on the evidential roles of randomised trials and mechanisms in Evidence-Based Medicine. Current 'best practice' usually involves excluding non-randomised trial evidence from systematic reviews in cases where randomised trials are available for inclusion in the reviews. The first paper challenges this practice and evaluates whether adding of evidence from non-randomised trials might improve the quality and precision of some systematic reviews. The second paper compares the alleged (...) methodological benefits of randomised trials over observational studies for investigating treatment benefits. It suggests that claims about the superiority of well-conducted randomised controlled trials over well-conducted observational studies are justified, especially when results from the two methods are contradictory. The third paper argues that postulating the unpredictability paradox in systematic reviews when no detectable empirical differences can be found requires further justification. The fourth paper examines the problem of absence causation in the context of explaining causal mechanisms and argues that a recent solution is incomplete and requires further justification. Solving the problem by describing absences as causes of 'mechanism failure' fails to take into account the effects of absences that lead to vacillating levels of mechanism functionality. The fifth paper criticises literature that has emphasised functioning versus 'broken' or 'non-functioning' mechanisms emphasising that many diseases result from increased or decreased mechanism function, rather than complete loss of function. Mechanistic explanations must account for differences in the effectiveness of performed functions, yet current philosophical mechanistic explanations do not achieve this. The last paper argues that the standard of evidence embodied in the ICE theory of technological function is too permissive for evaluating whether the proposed functions of medical technologies have been adequately assessed and correctly ascribed. It argues that high-quality evidence from clinical studies is necessary to justify functional ascriptions to health care technologies. (shrink)

Methadone maintenance therapy is a cost-effective, evidence-based treatment for heroin dependence. In the USA, a majority of heroin-dependent offenders are forced to detox from methadone when incarcerated. Recent research published in The Lancet has demonstrated the negative health and economic outcomes associated with such policies. Methadone Continuation Versus Forced Withdrawal on Incarceration in a Combined US Prison and Jail: A Randomised, Open Label Trial. The Lancet, 386, 350–359). This novel evidence raises questions as to the justification for current policies of (...) forced detox in American prisons. Opponents of methadone provision in prisons might offer arguments from retributivism, resource allocation and curative effectiveness to justify their position. This article contends that these arguments do not stand up to ethical scrutiny. In light of this, we hold that American policymakers should reform criminal justice policies to allow the initiation and continuation of methadone treatment in correctional settings. This would be consistent with both international recommendations and the example set by a number of other Western countries. (shrink)

This is a protocol for a Cochrane Review (Intervention). The objectives are as follows: -/- The main aim of this review will be to assess the effects of changing practitioner empathy or patient expectations for all conditions. The main objective is to conduct a systematic review of randomised trials where the intervention involves manipulating either (a) practitioner empathy or (b) patient expectations, or (c) both.

Pressure and influences on school leaders as school policy makers during COVID-19 have made the task of interpreting, translating and implementing guidance more a complex and essential operation. School leaders need to prioritise and balance ever-changing government policy advice, against limitations of school buildings, the welfare of students and staff as well as the needs of the communities their schools serve. By surveying and interviewing headteachers, senior leaders and governors, this paper identifies the inputs school leaders have had to react (...) and respond to when creating policy in the context of COVID-19. The paper addresses the nature of, and factors affecting, pressures school leaders feel in authoring policy. The considerable challenges school-based policy makers face in implementing social distancing policy are non-trivial and increase tension to what is already highly stressful work. The report draws on data collected from a randomised, stratified sample of primary and secondary school leaders from across England in early June 2020, during the time of social distancing and school closure for most students. Findings suggest quality, quantity and frequency of top-down communication have contributed to school leader stress, while horizontal communication and collaboration between school leaders and across school communities helped to support leaders during rapid change. We recommend government and the education sector address communication, collaboration and change, to harness the challenges and opportunities identified by school leaders during the COVID-19 pandemic. (shrink)

As a way to make medical decisions, Evidence-Based Medicine (EBM) has failed. EBM's failure arises from not being founded on real-world decision-making. EBM aspires to a scientific standard for the best way to treat a disease and determine its cause, but it fails to recognise that the scientific method is inapplicable to medical and other real-world decision-making. EBM also wrongly assumes that evidence can be marshaled and applied according to an hierarchy that is determined in an argument by authority to (...) the method by which it has been obtained. If EBM had valid theoretical, practical or empirical foundations, there would be no hierarchy of evidence. In all real-world decision-making, evidence stands or falls on its inherent reliability. This has to be and can only be assessed on a case-by-case basis applying understanding and wisdom against the background of all available facts—the "factual matrix." EBM's failure is structural and was inevitable from its inception. EBM confuses the inherent reliability and probative value of evidence with the means by which it is obtained. -/- EBM is therefore an ad hoc construct and is not a valid basis for medical decision-making. This is further demonstrated by its exclusion of relevant scientific and probative real-world decision-making evidence and processes. It draws upon a narrow evidence base that is itself inherently unreliable. It fails to take adequate account of the nature of causation, the full range of evidence relevant to its determination, and differing approaches to determining cause and effect in real-world decision-making. EBM also makes a muddled attempt to emulate the scientific method and it does not acknowledge the role of experience, understanding and wisdom in making medical decisions. (shrink)

This dissertation is an investigation into how scientific values may influence the kinds of theories which are investigated, and in turn which theories become ‘mainstream’. I have focussed on psychedelic therapy as a family of theories, and I identified three main reasons as to why psychedelic therapy is somewhat incompatible with the current psychiatric paradigm: (1) the inability to conduct double-blind trials, (2) The inability to isolate one explanatory variable, and (3) The mystical and spiritual dimensions of the mechanisms of (...) action of psychedelic drugs. Because double-blind randomised controlled trials, isolating one explanatory variable, and neurobiological- style explanations of mechanisms of action are seen as an integral part of good psychiatric research, this means that psychedelic therapy is inherently disadvantaged as a research avenue in the current paradigm. These three things also arguably embody scientific values proposed by Kuhn (1977), such as accuracy, simplicity, and consistency. Helen Longino (1995) argues that Kuhn’s values do not simply increase the likelihood of a theory being true, but in some instances serve to perpetuate discriminatory ideologies. She proposes her own list of values as a route to a more equitable science, and by extension, a more equitable society. Interestingly, psychedelic therapy as a theory embodies many, if not all of the values proposed by Longino. This led me to my conclusion that if the psychiatric paradigm were more feminist according to Longino’s criteria, then psychedelic therapy would be considered a “better” theory. It would therefore be easier to conduct research in this area, and psychedelic therapy would have a better chance at becoming a mainstream treatment. (shrink)

When does it make sense to act randomly? A persuasive argument from Bayesian decision theory legitimizes randomization essentially only in tie-breaking situations. Rational behaviour in humans, non-human animals, and artificial agents, however, often seems indeterminate, even random. Moreover, rationales for randomized acts have been offered in a number of disciplines, including game theory, experimental design, and machine learning. A common way of accommodating some of these observations is by appeal to a decision-maker’s bounded computational resources. Making this suggestion both precise (...) and compelling is surprisingly difficult. Toward this end, I propose two fundamental rationales for randomization, drawing upon diverse ideas and results from the wider theory of computation. The first unifies common intuitions in favour of randomization from the aforementioned disciplines. The second introduces a deep connection between randomization and memory: access to a randomizing device is provably helpful for an agent burdened with a finite memory. Aside from fit with ordinary intuitions about rational action, the two rationales also make sense of empirical observations in the biological world. Indeed, random behaviour emerges more or less where it should, according to the proposal. (shrink)

Sortition, i.e. random appointment for public duty, has been employed by societies throughout the years as a firewall designated to prevent illegitimate interference between parties in a legal case and agents of the legal system. In judicial systems of modern western countries, random procedures are mainly employed to select the jury, the court and/or the judge in charge of judging a legal case. Therefore, these random procedures play an important role in the course of a case, and should comply with (...) some principles, such as transparency and complete auditability. Nevertheless, these principles are neglected by random procedures in some judicial systems, which are performed in secrecy and are not auditable by the involved parties. The assignment of cases in the Brazilian Supreme Court is an example of such a procedure, for it is performed using procedures unknown to the parties involved in the judicial cases. This article presents a review of how sortition has been historically employed by societies and discusses how Mathematical Statistics may be applied to random procedures of the judicial system, as it has been applied for almost a century on clinical trials, for example. A statistical model for assessing randomness in case assignment is proposed and applied to the Brazilian Supreme Court. As final remarks, guidelines for the development of good randomization procedures are outlined. (shrink)

This article analyzes the role of entropy in Bayesian statistics, focusing on its use as a tool for detection, recognition and validation of eigen-solutions. “Objects as eigen-solutions” is a key metaphor of the cognitive constructivism epistemological framework developed by the philosopher Heinz von Foerster. Special attention is given to some objections to the concepts of probability, statistics and randomization posed by George Spencer-Brown, a figure of great influence in the field of radical constructivism.

Experimental balance is usually understood as the control for the value of the conditions, other than the one under study, which are liable to affect the result of a test. We will discuss three different approaches to balance. ‘Millean balance’ requires to identify and equalize ex ante the value of these conditions in order to conduct solid causal inferences. ‘Fisherian balance’ measures ex post the influence of uncontrolled conditions through the analysis of variance. In ‘efficiency balance’ the value of the (...) antecedent conditions is decided ex ante according to the efficiency they yield in the estimation of the treatment outcome. Against some old arguments by John Worrall, we will show that in both Fisherian and efficiency balance there are good reasons to randomize the allocation of treatments, in particular when there is no agreement among experimenters as to the antecedent conditions to be controlled for. (shrink)

Medical scientists employ ‘quality assessment tools’ (QATs) to measure the quality of evidence from clinical studies, especially randomized controlled trials (RCTs). These tools are designed to take into account various methodological details of clinical studies, including randomization, blinding, and other features of studies deemed relevant to minimizing bias and error. There are now dozens available. The various QATs on offer differ widely from each other, and second-order empirical studies show that QATs have low inter-rater reliability and low inter-tool reliability. This (...) is an instance of a more general problem I call the underdetermination of evidential significance. Disagreements about the strength of a particular piece of evidence can be due to different—but in principle equally good—weightings of the fine-grained methodological features which constitute QATs. (shrink)

While practitioners think highly of randomized studies, some philosophers argue that there is no epistemic reason to randomize. Here I show that their arguments do not entail their conclusion. Moreover, I provide novel reasons for randomizing in the context of interventional studies. The overall discussion provides a unified framework for assessing baseline balance, one that holds for interventional and observational studies alike. The upshot: practitioners’ strong preference for randomized studies can be defended in some cases, while still offering a nuanced (...) approach to evidence-appraisal, one where not all non-randomized studies are treated equally. (shrink)

It is sometimes thought that randomized study group allocation is uniquely proficient at producing comparison groups that are evenly balanced for all confounding causes. Philosophers have argued that in real randomized controlled trials this balance assumption typically fails. But is the balance assumption an important ideal? I run a thought experiment, the CONFOUND study, to answer this question. I then suggest a new account of causal inference in ideal and real comparative group studies that helps clarify the roles of confounding (...) variables and randomization. 1Confounders and Causes2The Balance Assumption3The CONFOUND Study 3.1CONFOUND 13.2CONFOUND 24Disjunction C and the Ideal Study 4.1The ultimate ‘other cause’: C4.2The ideal comparative group study4.3Required conditions for causal inference5Confounders as Causes, Confounders as Correlates6Summary. (shrink)

Intentional sampling methods are non-probabilistic procedures that select a group of individuals for a sample with the purpose of meeting specific prescribed criteria. Intentional sampling methods are intended for exploratory research or pilot studies where tight budget constraints preclude the use of traditional randomized representative sampling. The possibility of subsequently generalize statistically from such deterministic samples to the general population has been the issue of long standing arguments and debates. Nevertheless, the intentional sampling techniques developed in this paper explore pragmatic (...) strategies for overcoming some of the real or perceived shortcomings and limitations of intentional sampling in practical applications. (shrink)

In this article I give a critical evaluation of the use and limitations of null-model-based hypothesis testing as a research strategy in the biological sciences. According to this strategy, the null model based on a randomization procedure provides an appropriate null hypothesis stating that the existence of a pattern is the result of random processes or can be expected by chance alone, and proponents of other hypotheses should first try to reject this null hypothesis in order to demonstrate their own (...) hypotheses. Using as an example the controversy over the use of null hypotheses and null models in species co-occurrence studies, I argue that null-model-based hypothesis testing fails to work as a proper analog to traditional statistical null-hypothesis testing as used in well-controlled experimental research, and that the random process hypothesis should not be privileged as a null hypothesis. Instead, the possible use of the null model resides in its role of providing a way to challenge scientists’ commonsense judgments about how a seemingly unusual pattern could have come to be. Despite this possible use, null-model-based hypothesis testing still carries certain limitations, and it should not be regarded as an obligation for biologists who are interested in explaining patterns in nature to first conduct such a test before pursuing their own hypotheses. (shrink)

Current debates surrounding the virtues and shortcomings of randomization are symptomatic of a lack of appreciation of the fact that causation can be inferred by two distinct inference methods, each requiring its own, specific experimental design. There is a non-statistical type of inference associated with controlled experiments in basic biomedical research; and a statistical variety associated with randomized controlled trials in clinical research. I argue that the main difference between the two hinges on the satisfaction of the comparability requirement, which (...) is in turn dictated by the nature of the objects of study, namely homogeneous or heterogeneous populations of biological systems. Among other things, this entails that the objection according to which randomized experiments fail to provide better evidence for causation because randomization cannot guarantee comparability is mistaken. (shrink)

Debiasing procedures are experimental methods aimed at correcting errors arising from the cognitive biases of the experimenter. We discuss two of these methods, the predesignation rule and randomization, showing to what extent they are open to the experimenter’s regress: there is no metarule to prove that, after implementing the procedure, the experimental data are actually free from biases. We claim that, from a contractarian perspective, these procedures are nonetheless defensible since they provide a warrant of the impartiality of the experiment: (...) we only need proof that the result has not been intentionally manipulated for prima facie acceptance. (shrink)

Did the impartiality of clinical trials play any role in their acceptance as regulatory standards for the safety and efficacy of drugs? According to the standard account of early British trials in the 1930s and 1940s, their impartiality was just rhetorical: the public demanded fair tests and statistical devices such as randomization created an appearance of neutrality. In fact, the design of the experiment was difficult to understand and the British authorities took advantage of it to promote their own particular (...) interests. I claim that this account is based on a poorly defined concept of experimental fairness . I present an alternative approach in which a test would be impartial if it incorporates warrants of non-manipulability. With this concept, I reconstruct the history of British trials showing that they were indeed fair and this fairness played a role in their acceptance as regulatory yardsticks. (shrink)

Since its introduction just over two decades ago, evidence-based medicine (EBM) has come to dominate medical practice, teaching, and policy. There are a growing number of textbooks, journals, and websites dedicated to EBM research, teaching, and evidence dissemination. EBM was most recently defined as a method that integrates best research evidence with clinical expertise and patient values and circumstances in the treatment of patients. There have been debates throughout the early 21st century about what counts as good research evidence between (...) EBM proponents and philosophical critics and even within the EBM community itself. Similar controversy arises about the relative worth of patient values and clinical expertise (and how these can be integrated). EBM has also evolved in ways that have come under scrutiny. Specifically, policymakers have used EBM research methodology to increase the relative importance of clinical guidelines that some clinicians have argued are tyrannical. Philosophers have addressed all of these controversies, and with very few exceptions have been critical of EBM. In addition most philosophical attention has been on the epistemic role of Randomization and evidence hierarchies, with relatively little attention being paid to the role of Diagnosis, expertise, patient values, and Systematic Reviews within EBM. (shrink)

Causation has multiple distinct meanings in genetics. One reason for this is meaning slippage between two concepts of the gene: Mendelian and molecular. Another reason is that a variety of genetic methods address different kinds of causal relationships. Some genetic studies address causes of traits in individuals, which can only be assessed when single genes follow predictable inheritance patterns that reliably cause a trait. A second sense concerns the causes of trait differences within a population. Whereas some single genes can (...) be said to cause population-level differences, most often these claims concern the effects of many genes. Polygenic traits can be understood using heritability estimates, which estimate the relative influences of genetic and environmental differences to trait differences within a population. Attempts to understand the molecular mechanisms underlying polygenic traits have been developed, although causal inference based on these results remains controversial. Genetic variation has also recently been leveraged as a randomizing factor to identify environmental causes of trait differences. This technique—Mendelian randomization—offers some solutions to traditional epidemiological challenges, although it is limited to the study of environments with known genetic influences. (shrink)

Despite the growing popularity of participatory video as a tool for facilitating youth empower- ment, the methodology and impacts of the practice are extremely understudied. This paper des- cribes a study design created to examine youth media methodology and the ethical dilemmas that arose in its attempted implementation. Specifically, elements that added “rigor” to the study (i.e., randomization, pre- and post-measures, and an intensive interview) conflicted with the fun- damental tenets of youth participation. The paper concludes with suggestions for studying (...) par- ticipatory media methodologies that are more in line with an ethics of participation1. (shrink)

We present in this paper the neutrosophic randomized variables, which are a generalization of the classical random variables obtained from the application of the neutrosophic logic (a new nonclassical logic which was founded by the American philosopher and mathematical Florentin Smarandache, which he introduced as a generalization of fuzzy logic especially the intuitionistic fuzzy logic ) on classical random variables. The neutrosophic random variable is changed because of the randomization, the indeterminacy and the values it takes, which represent the possible (...) results and the possible indeterminacy. Then we classify the neutrosophic randomized variables into two types of discrete and continuous neutrosophic random variables and we define the expected value and variance of the neutrosophic random variable then offer some illustrative examples. -/- . (shrink)

In an attempt to curtail examination malpractice, the Joint Admission and Matriculation Board (JAMB) has been generating different paper types with a different order of test items in the Unified Tertiary Matriculation Examination (UTME). However, the permutation of test items may compromise students’ performance unintentionally because constructive suggestions in theory and practice recommend that test items be sequenced in ascending order of difficulty. This study used data collected from a random sample of 1,226 SSIII students to ascertain whether the permutation (...) of test items has any effect on the performance of students in two different subjects (Use of English and Mathematics). The study adopted the Equivalent Groups Quasi-Experimental Research Design with three independent groups. Findings emerged, amongst others, that there is a significant difference in the performance scores of prospective university students' in use of English and Mathematics examintaions arranged in three different orders (ED, DE, R). There are no significant gender differences in the performance of students in Use of English and Mathematics based on test item permutation. However female students perform better than male students when test items are arranged in ascending order of difficulty while males perform better when test items are arranged in descending order of difficulty. It was concluded that the permutation of test items in UTME examination tends to affect the performance of students in Use of English and Mathematics. This finding has implications for the future conduct of UTME examinations and enrolment into higher education as the randomization of UTME test items changes the difficulty order of different paper types. It was recommended that other measures of curtailing examination malpractices that would not affect students’ academic performance should be adopted. (shrink)

The principal goal of Alex John London's For the Common Good is to "articulate a new vision for the philosophical foundations of research ethics" which "moves issues of justice from the periphery of the field to the very center." At the core of this new vision is an understanding of research as a "collaborative social activity between free and equal persons," which aims to develop the knowledge public institutions require to establish and maintain a social order in which people may (...) set and pursue their plans of life. Clinical and social scientific research are not therefore morally optional activities, in London's view, but rather the way public institutions acquire the knowledge they... (shrink)