Bmc Med
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Global food systems are essential to sustain life; however, unhealthy diets are the leading cause of poor health and death worldwide. Natural food environments are a critical source of healthful food such as fresh fruit and vegetables, lean meat and aquatic foods, particularly in low- and middle-income countries (LMICs) and Indigenous food systems. Understanding and monitoring natural food environments is critical to protecting the supply of healthy food, and the land and water it comes from, for current and future generations. ⋯ Our review demonstrated that the concept and characteristics of the food environment are a promising conceptualization for measuring natural food environments, particularly in relation to food availability, healthiness and food security. Mapping the currently used methods and measures to assess natural food environments is important to help identify critical leverage points for strengthening policy interventions, and monitoring and evaluation of progress.
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Regulatory applications for cell therapy face more objections compared to conventional small molecule or biological drugs, leading to delays in market approval and clinical adoption. Increased regulatory objections frequently relate to issues regarding preclinical evidence, such as experimental design of animal studies, selection of animal models, endpoints, and determination of mechanism of action. Synthesis and clarification of the preclinical evidence necessary to demonstrate treatment efficacy and advance into early-phase clinical trials is needed to help researchers avoid regulatory objections. ⋯ Regulatory guidance for preclinical efficacy studies often recommends a strong emphasis on the clinical relevance of animal models, intervention parameters, outcomes, and mechanism of action. Incorporating these recommendations into early preclinical studies should improve the acceptability of preclinical evidence for approval by the relevant national regulators and can be used as a guide to ensure that all evidence that regulators say they expect is efficiently assembled into new clinical trial applications.
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Regulatory applications for cell therapy face more objections compared to conventional small molecule or biological drugs, leading to delays in market approval and clinical adoption. Increased regulatory objections frequently relate to issues regarding preclinical evidence, such as experimental design of animal studies, selection of animal models, endpoints, and determination of mechanism of action. Synthesis and clarification of the preclinical evidence necessary to demonstrate treatment efficacy and advance into early-phase clinical trials is needed to help researchers avoid regulatory objections. ⋯ Regulatory guidance for preclinical efficacy studies often recommends a strong emphasis on the clinical relevance of animal models, intervention parameters, outcomes, and mechanism of action. Incorporating these recommendations into early preclinical studies should improve the acceptability of preclinical evidence for approval by the relevant national regulators and can be used as a guide to ensure that all evidence that regulators say they expect is efficiently assembled into new clinical trial applications.
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Review Meta Analysis
The impact of contextual effects in exercise therapy for low back pain: a systematic review and meta-analysis.
Low back pain is the leading cause of global disability for which exercise therapy is a widely recommended treatment. Research indicates that contextual factors may also influence treatment outcomes in low back pain. Examples include the patient-therapist relationship and other treatment-related circumstances that affect patient expectations. By focusing on the specific treatment effect, clinical trials often ignore the effect of contextual factors, thereby contributing to the so-called efficacy paradox. This means that treatment effects observed in clinical practice are often greater than those reported in clinical trials. This systematic review aims to investigate the proportion of improvement in pain and disability that can be attributed to contextual effects in the outcome of exercise therapy for patients with low back pain. ⋯ A large extent of pain and disability improvement after exercise therapy in low back pain is attributable to contextual effects although this conclusion is based on low certainty evidence.
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Review Meta Analysis
The impact of contextual effects in exercise therapy for low back pain: a systematic review and meta-analysis.
Low back pain is the leading cause of global disability for which exercise therapy is a widely recommended treatment. Research indicates that contextual factors may also influence treatment outcomes in low back pain. Examples include the patient-therapist relationship and other treatment-related circumstances that affect patient expectations. By focusing on the specific treatment effect, clinical trials often ignore the effect of contextual factors, thereby contributing to the so-called efficacy paradox. This means that treatment effects observed in clinical practice are often greater than those reported in clinical trials. This systematic review aims to investigate the proportion of improvement in pain and disability that can be attributed to contextual effects in the outcome of exercise therapy for patients with low back pain. ⋯ A large extent of pain and disability improvement after exercise therapy in low back pain is attributable to contextual effects although this conclusion is based on low certainty evidence.