Mayo Clinic proceedings
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Mayo Clinic proceedings · Aug 2023
ReviewClinical Trials Overview: From Explanatory to Pragmatic Clinical Trials.
Clinical trials have been the bedrock of research to evaluate the safety and efficacy of new medical, surgical, or other interventions. Traditional "explanatory" clinical trials have aimed to explain a biological cause (new treatment) and effect (patient outcome) while controlling for many factors that might impact the evaluation, such as restricted eligibility criteria, frequent follow-up visits, and multiple clinical and laboratory measures. Despite the benefits of a well-controlled clinical trial, compromises have been made that can limit who might benefit from a new intervention, can increase complexity of the conduct of a trial, or that lead to excessively long durations of trials. ⋯ Although we describe explanatory and pragmatic trial designs as separate approaches, there is a continuum of approaches that intersect. Some key points are the need to maintain scientific rigor, increase efficiency of clinical trials operations, ensure that trial results can be generalized to a broad spectrum of patients, and balance the needs of real-world clinical care. Pragmatic trials can leverage technology and telecommunication strategies of decentralized trials to further reach underrepresented and underserved patients to close the health disparity gaps.
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Mayo Clinic proceedings · Aug 2023
ReviewQuestioning the Right to Pain Relief and Its Role in the Opioid Epidemic.
The new discipline of palliative care helped to establish the right to pain relief at the end of life and the necessity of using opioids to achieve that goal. Professional pain organizations followed the United Nations' model for universal human rights in their declaration of a universal right to pain management. Both palliative care and pain medicine specialties worked to establish pain as a legitimate focus of medical treatment separate from its association with disease. ⋯ This understanding of opioids as having distinct and separable analgesic and addictive potential was challenged by the 1970s discovery of an endogenous opioid system, which integrates pain and reward functions to support survival. Our modern pain neurophysiology places the patient with pain in a passive position from which it makes sense to assert a right to pain relief. To prevent future opioid epidemics we need to abandon clinical outpatient use of pain intensity scores and redefine the medical necessity of pain treatment as less about the reduction of pain intensity and more about the capacity to pursue personally valued activities.