Journal of evaluation in clinical practice
-
Evidence-based medicine (EBM), the dominant approach to assessing the effectiveness of clinical and public health interventions, focuses on the results of association studies. EBM+ is a development of EBM that systematically considers mechanistic studies alongside association studies. ⋯ (a) Assessment of combination therapy for MERS highlights the need for systematic assessment of mechanistic evidence. (b) That hypertension is a risk factor for severe disease in the case of SARS-CoV-2 suggests that altering hypertension treatment might alleviate disease, but the mechanisms are complex, and it is essential to consider and evaluate multiple mechanistic hypotheses. (c) Confidence that public health interventions will be effective requires a detailed assessment of social and psychological components of the mechanisms of their action, in addition to mechanisms of disease. (d) In particular, if vaccination programmes are to be effective, they must be carefully tailored to the social context; again, mechanistic evidence is crucial. We conclude that coronavirus research is best situated within the EBM+ evaluation framework.
-
Proponents of clinical case formulations argue that the causes and mechanisms contributing to and maintaining a patient's problems should be analysed and integrated into a case conceptualization, on which treatment planning ought to be based. Empirical evidence shows that an individualized treatment based on a case formulation is at least sometimes better than a standardized evidence-based treatment. ⋯ We show how PACT works in practice by discussing treatment planning for a clinical case involving symptoms of social anxiety, depression and post-traumatic stress disorder.
-
Though strong evidence-based medicine is assertive in its claims, an insufficient theoretical basis and patchwork of arguments provide a good case that rather than introducing a new paradigm, EBM is resisting a shift to actually revolutionary complexity theory and other emergent approaches. This refusal to pass beyond discredited positivism is manifest in strong EBM's unsuccessful attempts to continually modify its already inadequate previous modifications, as did the defenders of the Ptolemaic astronomical model who increased the number of circular epicycles until the entire epicycle-deferent system proved untenable. ⋯ The analysis in Part 1 of this three part series showed epistemological confusion as strong EBM plays the discredited positivistic tradition out to the end, thus repeating in a medical sphere and vocabulary the major assumptions and inadequacies that have appeared in the trajectory of modern science. Paper 2 in this series examines application, attending to strong EBM's claim of direct transferability of EBM research findings to clinical settings and its assertion of epistemological normativity. EBM's contention that it provides the "only valid" approach to knowledge and action is questioned by analyzing the troubled story of proposed hierarchies of the quality of research findings (especially of RCTs, with other factors marginalized), which falsely identifies evaluating findings with operationally utilizing them in clinical recommendations and decision-making. Further, its claim of carrying over its normative guidelines to cover the ethical responsibilities of researchers and clinicians is questioned.
-
This paper explores the possibility of AI-based addendum therapy for borderline personality disorder, its potential advantages and limitations. Identity disturbance in this condition is strongly connected to self-narratives, which manifest excessive incoherence, causal gaps, dysfunctional beliefs, and diminished self-attributions of agency. ⋯ The suggestion of this paper is that human-to-human therapy could be complemented by AI assistance holding out the promise of making patients' self-narratives more coherent through improving the accuracy of their self-assessments, reflection on their emotions, and understanding their relationships with others. Theoretical and pragmatic arguments are presented in favour of this idea, and certain technical solutions are suggested to implement it.
-
Randomized Controlled Trial
Distinctive aspects of consent in pilot and feasibility studies.
Prior to a main randomized clinical trial, investigators often carry out a pilot or feasibility study in order to test certain trial processes or estimate key statistical parameters, so as to optimize the design of the main trial and/or determine whether it can feasibly be run. Pilot studies reflect the design of the intended main trial, whereas feasibility studies may not do so, and may not involve allocation to different treatments. Testing relative clinical effectiveness is not considered an appropriate aim of pilot or feasibility studies. ⋯ Equipoise may also be particularly challenging to grasp in the context of a pilot study. The consent process in pilot and feasibility studies requires a particular focus, and careful communication, if it is to carry the appropriate moral weight. There are corresponding implications for the process of ethical approval.