USING A BLOCKED-TRIALS PROCEDURE TO TEACH IDENTITY MATCHING TO A CHILD WITH AUTISM

Children with autism may struggle in developing conditional discrimination repertoires. Saunders and Spradlin (1989 , 1990 , 1993 ) arranged “blocked” teaching trials in which they presented the same sample stimulus repeatedly across trials (in lieu of randomly alternating targets across trials) and then faded the number of trials in each block. We replicated the effects of this blocked‐trials procedure in teaching identity matching to a child with autism and evaluated the necessity of fading. Arranging blocked trials facilitated the acquisition of identity matching, but fading the block size was not necessary to maintain discriminated performance.     

Early childhood education and crime

This article presents new evidence on the crime-reducing impacts of a high-quality, intensive early childhood program with long-term follow-up, evaluated by a randomized controlled trial. Proportionately, more women than men decrease their criminal activity after participating in the program. This gender difference arises because of the worse home environments for girls, with corresponding greater scope for improvement by the program. For both genders, treatment effects are larger for the least-advantaged children, as measured by their mother's education at baseline. The dollar value of the social cost of criminal activity averted is higher for men because they commit more costly violent crimes.     

How Civil Society Organisations Changed the Regulation of Clinical Trials in India

ABSTRACT

In 2005 India changed its pharmaceutical and innovation policy that facilitated a dramatic increase in international clinical trials involving study sites in India. This policy shift was surrounded by controversies; civil society organisations (CSOs) criticised the Indian government for promoting the commercialisation of pharmaceutical research and development. Health social movements in India fought for social justice through collective action, and engaged in normative reasoning of the benefits, burdens and equality of research. They lobbied to protect trial participants from structural violence that occurred especially in the first 5–6 years of the new policy. CSOs played a major role in the introduction of new regulations in 2013, which accelerated a decline in the number of global trials carried out in India. This activism applied interpretations of global social justice as key ideas in mobilisation, eventually helping to institutionalise stricter ethical regulation on a national level. Like government and industry, activists believed in randomised controlled trials and comparison as key methods for scientific knowledge production. However, they had significant concerns about the global hierarchies of commercial pharmaceutical research, and their impact on the rights of participants and on benefits for India overall. Pointing to ethical malpractices and lobbying for stricter ethical regulations, they aimed to ensure justice for research participants, and developed effective strategies to increase controls over the business side of clinical research.     

Eye movement desensitization and reprocessing for mental health problems: a systematic review and meta-analysis

ABSTRACT

There is no comprehensive meta-analysis of randomised trials examining the effects of Eye Movement Desensitization and Reprocessing (EMDR) on post-traumatic stress disorder (PTSD) and no systematic review at all of the effects of EMDR on other mental health problems. We conducted a systematic review and meta-analysis of 76 trials. Most trials examined the effects on PTSD (62%). The effect size of EMDR compared to control conditions was g = 0.93 (95% CI: 0.67–.18), with high heterogeneity (I²= 72%). Only four of 27 studies had low risk of bias, and there were indications for publication bias. EMDR was more effective than other therapies (g = 0.36; 95% CI: 0.14–0.57), but not in studies with low risk of bias. Significant results were also found for EMDR in phobias and test anxiety, but the number of studies was small and risk of bias was high. EMDR was examined in several other mental health problems, but for none of these problems, sufficient studies were available to pool outcomes. EMDR may be effective in the treatment of PTSD in the short term, but the quality of studies is too low to draw definite conclusions. There is not enough evidence to advise it for the use in other mental health problems.     

Psychoanalysis and evaluation: a stratified model focused on the uniqueness of the case

ABSTRACT

Objectives: This article addresses the methodological controversies surrounding the issue of how to evaluate the psychotherapies. It proposes to identify the principles of an integrative and stratified model in order to report the results of analytical therapy (its efficacy) based on the very effectiveness of its processes. Thus, the uniqueness of the case is put at the center of the evaluation setting.

Methods: Drawing on science studies, the authors engage in a reflexive exercise on the problem of psychoanalysis’ evaluation based on methodological questions raised in the field over time and current issues related to practice.

Results: First, the regularly asserted opposition between the norms of analytical practice and those governing standard evaluation procedures is reinterpreted as the effect of a lack of intermediate epistemic patterns.

Second, the fundamental principles of an integrative model are considered so as to translate and articulate a set of heterogeneous requirements into distinct strata.

Discussion: Since psychoanalysis is fundamentally a case-by-case practice characterized by inequivalence and unexpectedness, its utmost aim is to use a type of effectiveness based on the singularity of the case. However, this does not prevent it from being evaluable provided that the epistemic levels of the evaluation are clearly differentiated.     

Global Diversification in Medicine Regulation: Insights from Regenerative Stem Cell Medicine

ABSTRACT

Medicine regulation worldwide has undergone a process of regulatory diversification. The evidence-based medicine (EBM) paradigm, centered on multi-phase randomized controlled trials, is increasingly contested and replaced by new models of clinical validation. To explain these changes, STS research has cited just a few factors, e.g. growing pressure form health consumers; the role of pharmaceutical companies to lobby for fast, affordable drug development; the influence of neoliberal ideas and libertarian advocacy of deregulation; and the agency of national governments to enable domestic innovation opportunities in the context of global competition and inequalities. Those factors individually cannot account for the increasing variation in medicine regulation at both national and global levels. Instead it is helpful to integrate elements of existing explanations into a framework with four pairs of conflicting regulatory choices, which play a central role in the formation of medicine regulation. We use this framework to compare regulatory changes in the USA, European Union, China, India, Argentina, and Japan. Across these jurisdictions, the case studies illustrate four dynamics of diversification. Key regulatory concepts such as evidence, risk, safety, efficacy, responsibility and accountability acquire different meanings, reshaping medicine innovation in far-reaching and often contradictory ways. The boundaries between medical research and healthcare provision, commerce and humanitarian service, as well as state control and medical self-regulation are re-defined.     

Standards,Harmonization and Cultural Differences: Examining the Implementation of a European Stem Cell Clinical Trial

ABSTRACT

A complex set of European regulations aims to facilitate regenerative medicine, harmonizing good clinical and manufacturing standards and streamlining ethical approval procedures. The sociology of standardization has elaborated some of the effects of regulation but little is known about how such implementation works in practice across institutions and countries in regenerative medicine. The effects of transnational harmonization of clinical trial conduct are complex. A long-term ethnographic study alongside a multinational clinical trial finds a range of obstacles. Harmonization standardizes at one level, but implementing the standards brings to the fore new layers of difference between countries. Europe-wide harmonization of regulations currently disadvantages low-cost clinician-lead research in comparison to industry-sponsored clinical trials. Moreover, harmonized standards must be aligned with the cultural variations in everyday practice across European countries. Each clinical team must find its own way of bridging harmonized compulsory practice with how things are done where they are, respecting expectations from both patients and the local hospital ethics committee. Established ways of working must further be adapted to a range of institutional and cultural conventions that affect the clinical trial such as insurance practices and understandings of patient autonomy. An additional finding is that the specific practical roles of team members in the trial affect their evaluation of the importance of these challenges. Our findings lead to conclusions of wider significance for the sociology of standards concerning how regulation works and for medical sociology about how trial funding and research directions in stem cell medicine intersect.     

Alter-Standardizing Clinical Trials: The Gold Standard in the Crossfire

ABSTRACT

The international landscape of medical research is in the midst of a process of diversification and change. The randomized controlled trial (RCT), long considered the global gold standard for clinical research, has become increasingly contested and is partly replaced by alternative methodologies, standards and forms of evidence. The contours of mainstream medical research are changing as a result. Regulatory paradigms and standards are, literally, being rewritten, at a global level. The evidence-based medicine (EBM) hierarchy of evidence is redefined. This special issue explores these developments through the concept of ‘alter-standardization’. The term refers to the processes, controversies and negotiations through which multiphase RCTs and the EBM system are challenged and gradually superseded by alternative methodological and regulatory forms and standards. This special issue examines the conceptual, practical and theoretical implications of these changes, and the ways in which these transformations influence the situation and possibilities of patients, knowledge producers, physicians, large pharmaceutical corporations, smaller biotech companies, as well as regulatory bodies, civil societal organizations and national health care systems. The articles in this special issue make use of comparative and historical perspectives that focus on scientific, social, economic and regulatory developments in the European Union, China, India, Japan, Argentina, the UK and the USA. They show that the alter-standardizing of clinical trials arises in a pluralistic way, that is driven by a variety of often conflicting factors, developments and expectations. These changes reflect a broad transformation in the culture and politics of biomedicine today, with implications for the ways in which new medicinal products, devices, procedures and technologies are developed, approved for clinical use, sold to consumers, and licensed by health care systems.