Evidence-based Medicine Paradigm Research Articles

Comparing generative and extractive approaches to information extraction from abstracts describing randomized clinical trials

BackgroundSystematic reviews of Randomized Controlled Trials (RCTs) are an important part of the evidence-based medicine paradigm. However, the creation of such systematic reviews by clinical experts is costly as well as time-consuming, and results can get quickly outdated after publication. Most RCTs are structured based on the Patient, Intervention, Comparison, Outcomes (PICO) framework and there exist many approaches which aim to extract PICO elements automatically. The automatic extraction of PICO information from RCTs has the potential to significantly speed up the creation process of systematic reviews and this way also benefit the field of evidence-based medicine.ResultsPrevious work has addressed the extraction of PICO elements as the task of identifying relevant text spans or sentences, but without populating a structured representation of a trial. In contrast, in this work, we treat PICO elements as structured templates with slots to do justice to the complex nature of the information they represent. We present two different approaches to extract this structured information from the abstracts of RCTs. The first approach is an extractive approach based on our previous work that is extended to capture full document representations as well as by a clustering step to infer the number of instances of each template type. The second approach is a generative approach based on a seq2seq model that encodes the abstract describing the RCT and uses a decoder to infer a structured representation of a trial including its arms, treatments, endpoints and outcomes. Both approaches are evaluated with different base models on a manually annotated dataset consisting of RCT abstracts on an existing dataset comprising 211 annotated clinical trial abstracts for Type 2 Diabetes and Glaucoma. For both diseases, the extractive approach (with flan-t5-base) reached the best F1\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$F_1$$\\end{document} score, i.e. 0.547 (±0.006\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\pm 0.006$$\\end{document}) for type 2 diabetes and 0.636 (±0.006\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$\\pm 0.006$$\\end{document}) for glaucoma. Generally, the F1\\documentclass[12pt]{minimal} \\usepackage{amsmath} \\usepackage{wasysym} \\usepackage{amsfonts} \\usepackage{amssymb} \\usepackage{amsbsy} \\usepackage{mathrsfs} \\usepackage{upgreek} \\setlength{\\oddsidemargin}{-69pt} \\begin{document}$$F_1$$\\end{document} scores were higher for glaucoma than for type 2 diabetes and the standard deviation was higher for the generative approach.ConclusionIn our experiments, both approaches show promising performance extracting structured PICO information from RCTs, especially considering that most related work focuses on the far easier task of predicting less structured objects. In our experimental results, the extractive approach performs best in both cases, although the lead is greater for glaucoma than for type 2 diabetes. For future work, it remains to be investigated how the base model size affects the performance of both approaches in comparison. Although the extractive approach currently leaves more room for direct improvements, the generative approach might benefit from larger models.

Overall average treatment effects from clinical trials, one-variable-at-a-time subgroup analyses and predictive approaches to heterogeneous treatment effects: Toward a more patient-centered evidence-based medicine.

Despite the predominance of the evidence-based medicine paradigm, a fundamental incongruity remains: Evidence is derived from groups of people, yet medical decisions are made by and for individuals. Randomization ensures the comparability of treatment groups within a clinical trial, which allows for unbiased estimation of average treatment effects. If we treated groups of patients instead of individuals, or if patients with the same disease were identical to one another in all factors that determined the harms and the benefits of therapy, then these group-level averages would make a perfectly sound foundation for medical decision-making. But patients differ from one another in many ways that determine the likelihood of an outcome, both with and without a treatment. Nevertheless, popular approaches to evidence-based medicine have encouraged a reliance on the average treatment effects estimated from clinical trials and meta-analysis as guides to decision-making for individuals. Here, we discuss the limitations of this approach as well as limitations of conventional, one-variable-at-a-time subgroup analysis; finally, we discuss the rationale for "predictive" approaches to heterogeneous treatment effects. Predictive approaches to heterogeneous treatment effects combine methods for causal inference (e.g. randomization) with methods for prediction that permit inferences about which patients are likely to benefit and which are not, taking into account multiple relevant variables simultaneously to yield "personalized" estimates of benefit-harm trade-offs. We focus on risk modeling approaches, which rely on the mathematical dependence of the absolute treatment effect with the baseline risk, which varies substantially "across patients" in most trials. While there are a number of examples of risk modeling approaches that have been practice-changing, risk modeling does not provide ideal estimates of individual treatment effects, since risk modeling does not account for how individual variables might modify the effects of therapy. In "effect modeling," prediction models are developed directly on clinical trial data, including terms for treatment and treatment effect interactions. These more flexible approaches may better uncover individualized treatment effects, but are also prone to overfitting when dimensionality is high, power is low, and there is limited prior knowledge about effect modifiers.

Using legal doctrine and feminist theory to move beyond shared decision making for the practice of consent

The necessity of consent is widely justified on the basis of the principle of respect for autonomy. Also, it is widely believed that shared decision making (SDM) is the practical device to seek patients’ consent for medical treatment. In this essay, I argue that SDM, while necessary, is insufficient for consent; because, in the paradigm of evidence-based medicine, SDM is contingent upon other practices to identify appropriate treatments that form the subjects of SDM. Indeed, case law emphasises normative decision-making practices that precede SDM. Furthermore, case law supplies a nuanced understanding of SDM, which includes not only exchange of information but also attention to human vulnerability that persists despite formal retention of decision-making capacity. In addition, the law marks out a space in which people with capacity are absolutely entitled to self-determination. Thus, a four-step framework of decision making can be induced from legal doctrine. This legal framework corresponds to a construct of respect for autonomy that draws upon feminist theory. Feminist scholars have objected to the focus on individuals in traditional theories of autonomy; instead, they insist that people have to be considered in the context of their social influences and relationships. Feminists separate out four ideas of autonomy, and these ideas can be used to construct a four-layered model of respect for autonomy, in which each layer corresponds sequentially to a step in the legal framework of decision making. This model of respect for autonomy provides both conceptual clarity and theoretically robust justification for doctors’ various obligations in decision-making practices for consent.

Evidence-based medicine and physicians’ institutional agency in Russian clinical settings

ABSTRACT In 1990s’ Russia, a wave of internationalization brought an evidence-based medical paradigm to Russian healthcare. Whilst there has been considerable critical commentary on the consequences of adopting this paradigm for medical decision-making, much of this relates to specific contexts in Europe, north America and Australasia, with little research addressing post-Soviet clinical practice. Drawing on semi-structured qualitative interviews with Russian physicians, this article explores the entanglements between the introduction of evidence-based medicine (EBM) in the country and the transformation of post-socialist medical professionalism. I single out physicians’ efforts to reconcile the EBM paradigm with organizational constraints as indicative of professionals’ ground-level agency. I define the following components of such agency: (1) selective application of guidelines and use of foreign clinical recommendations; (2) establishing local professional solidarity; (3) developing relationships based on personalized trust with the patients. The study employs two sets of data (gathered in 2018 and in 2020) to trace the EBM-related agency of medical professionals both before and during COVID-19 pandemic. By offering analytical insights from post-socialist healthcare, where doctors’ discretion has historically been limited by excessive state control, the article contributes to academic debate on medical professionals’ autonomy and agency in the era of EBM-related standardization.

Automatic knowledge graph population with model-complete text comprehension for pre-clinical outcomes in the field of spinal cord injury

The paradigm of evidence-based medicine requires that medical decisions are made on the basis of the best available knowledge published in the literature. Existing evidence is often summarized in the form of systematic reviews and/or meta-reviews and is rarely available in a structured form. Manual compilation and aggregation is costly, and conducting a systematic review represents a high effort. The need to aggregate evidence arises not only in the context of clinical trials, but is also important in the context of pre-clinical animal studies. In this context, evidence extraction is important to support translation of the most promising pre-clinical therapies into clinical trials or to optimize clinical trial design. Aiming at developing methods that facilitate the task of aggregating evidence published in pre-clinical studies, in this paper a new system is presented that automatically extracts structured knowledge from such publications and stores it in a so-called domain knowledge graph. The approach follows the paradigm of model-complete text comprehension by relying on guidance from a domain ontology creating a deep relational data-structure that reflects the main concepts, protocol, and key findings of studies. Focusing on the domain of spinal cord injuries, a single outcome of a pre-clinical study is described by up to 103 outcome parameters. Since the problem of extracting all these variables together is intractable, we propose a hierarchical architecture that incrementally predicts semantic sub-structures according to a given data model in a bottom-up fashion. At the heart of our approach is a statistical inference method that relies on conditional random fields to infer the most likely instance of the domain model given the text of a scientific publication as input. This approach allows modeling dependencies between the different variables describing a study in a semi-joint fashion. We present a comprehensive evaluation of our system to understand the extent to which our system can capture a study in the depth required to enable the generation of new knowledge. We conclude the article with a brief description of some applications of the populated knowledge graph and show the potential implications of our work for supporting evidence-based medicine.

Is Machine Learning Changing Evidence-Based Medicine?

The paradigm of evidence-based medicine has become a fundamental part of health care and health professions education since the 1990s, even as it has drawn criticism. Meanwhile, in the past decade, increased data collection and computational power have brought about advances in machine learning, such as diagnostic algorithms for pattern recognition in medical images. Machine learning has potential to address some of the limitations of evidence-based medicine, but also presents new questions about what counts as evidence in medicine. Critical appraisal of machine learning can become part of the teaching of evidence-based medicine.

Philosophy and psychotherapy

What is psychotherapy? The answer to this question remains open, and experts then start arguing again about determining the place of psychotherapy in the modern field of scientific knowledge, then return to the capacious definition of B.D. Karvasarsky, according to which psychotherapy is a system of specific effective therapeutic forms of effects on the psyche, and through the psyche on the human body, in order to ensure and preserve his health. In the science–practice continuum, psychotherapy tends to practice to a greater extent, but many questions arise: on what scientific and methodological basis is this practice carried out, how can we talk about the effectiveness of psychotherapy based on the paradigm of evidence-based medicine based on positivist and neo-positivist concepts of philosophy?

Psychosis and psychedelics: Historical entanglements and contemporary contrasts.

Experiences of psychedelics and psychosis were deeply entangled in scientific practices in the mid-20th century, from uses of psychedelic drugs that could model psychosis, to detailed phenomenological comparisons of endogenous and drug-induced madness. After the moral panic of the 1960s shut down psychedelic research, however, these two phenomena became disentangled. In the decades following, the science of psychosis transformed, shedding the language of psychoanalysis, and adopting the new scientific veneer of psychiatry. Today, as psychedelic science re-emerges, the research programs surrounding psychosis and psychedelics now stand in stark contrast. Here, I look closely at how these research programs respond to questions related to what is worth measuring, what is worth investigating, and how we ought to respond to these experiences. This comparison reveals radically different assumptions and values that guide each research paradigm and shape clinical practice. While psychedelic research often includes scales that seek to capture experiences of mysticism, meaningfulness, and ego dissolution, research related to psychosis focuses on the measurement of pathological symptoms and functioning. Research into psychosis primarily seeks universal and reductionist causal explanations and interventions, while psychedelic research embraces the importance of set and setting in shaping unique experiences. Responses to psychedelic crisis involve warmth, compassion, and support, while responses to psychotic experiences often involve restraint, seclusion, and weapons. I argue that these differences contain important lessons for psychiatry. However, as psychedelic research struggles to meet regulatory requirements and fit within the paradigm of evidence-based medicine, these differences may quickly dissolve.

Mental health and the COVID-19 pandemic

Introduction: The disease caused by the SARS-CoV-2 virus is a significant threat to human life and health. It is highly contagious and therefore spreads rapidly and is fatal in severe cases. The main purpose of this article is to present the mental health impact of the COVID-19 pandemic.
 Method: Based on the review of the current literature based on the EBM (Evidence-Based Medicine) paradigm, the main mental health problems resulting from the pandemic are presented. During data collection, the PubMed search engine servicing the MEDLINE database and Google Scholar were used. The criterion that was used when searching for articles were papers published from 2020 available in Polish or English.
 Results: The SARS-CoV-2 virus infection itself, as well as the restrictions related to the pandemic, cause a number of negative consequences for mental health. They can manifest themselves as single symptoms or complexes of symptoms, as well as disorders or groups of disorders and complex problems of a psychopathological nature. All these phenomena can overlap and appear in the course of COVID-19, as well as its complications. The data available from the literature review show that during a pandemic, about 30% of people suffer from mental disorders, and over 50% of respondents report psychological distress. Mental health neglect during a pandemic may cause worsening disorders that may reveal themselves over the years.
 Conclusions: There are many options for combating the negative effects of a pandemic, which can be introduced at different levels. The impact of COVID-19 on the mental state of individual populations should be investigated and precisely defined, as it is necessary for planning short-term and long-term interventions in the areas of: medical, information and organizational. The full potential of many scientific disciplines should be used to contain the spread of the negative effects of a pandemic.

An annotated corpus of clinical trial publications supporting schema-based relational information extraction

BackgroundThe evidence-based medicine paradigm requires the ability to aggregate and compare outcomes of interventions across different trials. This can be facilitated and partially automatized by information extraction systems. In order to support the development of systems that can extract information from published clinical trials at a fine-grained and comprehensive level to populate a knowledge base, we present a richly annotated corpus at two levels. At the first level, entities that describe components of the PICO elements (e.g., population’s age and pre-conditions, dosage of a treatment, etc.) are annotated. The second level comprises schema-level (i.e., slot-filling templates) annotations corresponding to complex PICO elements and other concepts related to a clinical trial (e.g. the relation between an intervention and an arm, the relation between an outcome and an intervention, etc.).ResultsThe final corpus includes 211 annotated clinical trial abstracts with substantial agreement between annotators at the entity and scheme level. The mean Kappa value for the glaucoma and T2DM corpora was 0.74 and 0.68, respectively, for single entities. The micro-averaged F1 score to measure inter-annotator agreement for complex entities (i.e. slot-filling templates) was 0.81.The BERT-base baseline method for entity recognition achieved average micro- F1 scores of 0.76 for glaucoma and 0.77 for diabetes with exact matching.ConclusionsIn this work, we have created a corpus that goes beyond the existing clinical trial corpora, since it is annotated in a schematic way that represents the classes and properties defined in an ontology. Although the corpus is small, it has fine-grained annotations and could be used to fine-tune pre-trained machine learning models and transformers to the specific task of extracting information about clinical trial abstracts.For future work, we will use the corpus for training information extraction systems that extract single entities, and predict template slot-fillers (i.e., class data/object properties) to populate a knowledge base that relies on the C-TrO ontology for the description of clinical trials. The resulting corpus and the code to measure inter-annotation agreement and the baseline method are publicly available at https://zenodo.org/record/6365890.

Children with disabilities and their families during the COVID-19 pandemic - literature review

The difficult situation in which the whole society suddenly found itself due to the SARS-CoV-2 virus pandemic causing the COVID-19 disease, has disintegrated everyday life, arousing fear and carrying many negative consequences. Children with disabilities and their families are in a difficult position, for whom the pandemic crisis also overlaps with other problems related to disability. The main purpose of the article is to present the actual situation of children with disabilities and their families during the COVID-19 pandemic. Based on the review of the current literature based on the EBM (Evidence-Based Medicine) paradigm, the characteristics of the functioning and selected problems of this group, as well as the negative effects of the pandemic affecting it, have been presented.

Specialized nutrition for athletes: evaluation of ergogenic action using the principles of evidence-based medicine

The aim is to form a balanced position regarding the ergogenic characteristics of new sports food products in the modern practice of training highly qualified athletes on the basis of clinical-experimental evaluation of the effectiveness of special purpose real food additives. Materials and methods. Studies were carried out on laboratory animals (36 Wistar rats at the age of 3 months weighing 150–200 g and 16 Svetlogorsk mini-pigs) as well as on 102 high-qualified representatives of cyclic sports (all men aged 19–26) − members of national teams such as swimming (25), cross-country athletics (53), and skiing (24). As a control group, we studied 25 athletes of the same gender (all men), age and qualifications who received a placebo (starch capsules) for a long time during exercise. Placebo-controlled studies have been conducted on laboratory animals and athletes in compliance with the principles of bioethics. Results. It has been established that in the experiment the application of a new specialized food product MioActiv has a positive effect on the physical performance of animals and delays the onset of fatigue, which significantly exceeds the corresponding characteristics in the placebo group. Athletes also showed an increase in speed when passing competitive distances by 18.7–21.4% (p < 0,05), as well as a significant increase in mental endurance indicators (p < 0,05). The approbation of the innovative pre-workout pharmacological nutrient complex Pre-Fuse also showed the high efficacy and safety of this product with a positive effect of increasing the performance and endurance of animals, as well as the parameters of mental performance of athletes in the main groups, in contrast to the data in the placebo control groups. Conclusions. An analysis of the prescription components of new types of ergogenic sports nutrition and the presented results of preclinical and clinical studies conducted on the basis of the evidence-based medicine paradigm regarding the effectiveness of specialized products indicate the complex action of these funds on various aspects of both physical and mental performance. From the materials presented in the article, it can be seen that specialized sports nutrition products of an ergogenic orientation can provide significant assistance in increasing sports results.

Selected problems of prematurity and prematurely born child care

The evolution of perinatology and the progress of advanced methods of prenatal diagnosis have contributed to the rise of frequency of birth and survival of newborns with very low birth weight, born before 32 weeks of pregnancy. A three-tier perinatology care system in Poland, an increasingly outstanding knowledge of neonatologists, and newer and more advanced equipment for critical care therapy, all provide growingly safer conditions for the life and development of prematurely born children. Prematurity is not only a problem of the preterm baby, but poses a challenge for the family, notably the mother, who must face the challenges of care of the preterm baby. In this article, selected problems of prematurity and care of a preterm baby are presented. The most common causes of preterm birth incidence are reported. The mother’s situation after a preterm birth is defined. Based on the current literature, the profile of preterm babies and the EBM (Evidence-Based Medicine) paradigm, the rules for treatment and care for a preterm baby are presented.

In Reply to van Zanten et al.

We thank van Zanten and colleagues for their interest in our review. Both the Educational Commission for Foreign Medical Graduates (ECFMG) and the World Federation for Medical Education have important influence over medical education on a global scale. We agree that for global accreditation to work, there must be a form of standardized process for approving the local accreditors and ultimately, the medical schools. Our core argument, however, is that this always carries an inherent danger of silencing important nuances in local needs and resources that affect training models. 1 We hope we have raised awareness about assumptions that are inherent in concepts, such as “standardization.” 2 Standardization is a common theme in both medicine and medical education, which may in part be driven by the biomedical paradigm of evidence-based medicine. Proponents of standardization in global standard development emphasize its role in improving quality in both training and patient care and facilitating movement of health professionals. However, as stated by Timmermans, “standardization may seem to be politically neutral on the surface, but in fact, it poses sharp questions for democracy.” 3 Standardization has been criticized for driving a loss of identity and social power and being vulnerable to implementation gaps. 3 Sefton describes the tensions inherent in meeting specific local community health needs while addressing international requirements or standards. 4 Our position is not to eliminate global efforts, such as those in accreditation and curriculum design, but to recognize the complexity and subtleties between local priorities and global differences. We acknowledge the articulated benefits of the new system proposed by the ECFMG. However, we argue that the unanticipated and unintended effects of power relations must be consciously examined, reported, and corrected. As stated in the ECFMG’s 2010 announcement, “the efficacy of such a requirement depends on a universally accepted accreditation process.” 6 Achieving a “universally accepted” accreditation process is likely impossible. For this reason, we argue that we must track which institutions/regions do not end up participating in the new system and, most importantly, why they do not. 5

A Clinical Decision Support System (KNOWBED) to Integrate Scientific Knowledge at the Bedside: Development and Evaluation Study.

BackgroundThe evidence-based medicine (EBM) paradigm requires the development of health care professionals’ skills in the efficient search of evidence in the literature, and in the application of formal rules to evaluate this evidence. Incorporating this methodology into the decision-making routine of clinical practice will improve the patients’ health care, increase patient safety, and optimize resources use.ObjectiveThe aim of this study is to develop and evaluate a new tool (KNOWBED system) as a clinical decision support system to support scientific knowledge, enabling health care professionals to quickly carry out decision-making processes based on EBM during their routine clinical practice.MethodsTwo components integrate the KNOWBED system: a web-based knowledge station and a mobile app. A use case (bronchiolitis pathology) was selected to validate the KNOWBED system in the context of the Paediatrics Unit of the Virgen Macarena University Hospital (Seville, Spain). The validation was covered in a 3-month pilot using 2 indicators: usability and efficacy.ResultsThe KNOWBED system has been designed, developed, and validated to support clinical decision making in mobility based on standards that have been incorporated into the routine clinical practice of health care professionals. Using this tool, health care professionals can consult existing scientific knowledge at the bedside, and access recommendations of clinical protocols established based on EBM. During the pilot project, 15 health care professionals participated and accessed the system for a total of 59 times.ConclusionsThe KNOWBED system is a useful and innovative tool for health care professionals. The usability surveys filled in by the system users highlight that it is easy to access the knowledge base. This paper also sets out some improvements to be made in the future.

The Contingency of the Lifeworld in a World of Standards. Repertoires of Resignification in (Evidence-Based) Healthcare Organization

In this article I discuss the irremediable tension between the universalistic dimension of contemporary medicine, represented by the paradigm of evidence-based medicine (EBM), and local daily practices in specific healthcare organizations. This tension constantly challenges the unitary, universalistic vision to which modern medicine and science aspire. The EBM paradigm, which is currently the most prevalent in every medical-nursing discipline, aims to standardize care procedures through the process of constant scientific literature review and the production of operational guidelines based on what epistemic communities define as the most reliable and effective results: the so-called gold standards. In everyday clinical, therapeutic, and care activities, these procedures are intertwined with the multiplicity of elements that make up the lifeworld. “Universalistic” premises are never merely “applied” to “local” interactive contexts but are always creatively “implicated” in them. Using data collected during a year of ethnographic research in an intensive care unit in Northern Italy, I discuss how the abstract indications of EBM and the formal dimension of health organizations are incorporated, through socially located interactive repertoires, in actual care trajectories. Following the Science and Technology Study perspective in a practice-based analysis of daily work, I show how interactions between human actors, technological artifacts and organizational apparatus in daily practices constituterepertoires of resignificationthrough which local universality emerges, resolving the tension between medicine's universalistic aspirations and the unpredictable, situated nature of the lifeworld. I consider two repertoires: the interpretative (examining the production and dissemination of knowledge) and the relational (focusing on informal interactions between different professional groups and communities of practice). The article shows how care practices cannot disregard the specific organizational conditions in which they unfold and suggests that research should develop reflective analysis skills on what Annemarie Mol calls thelogic of care, thus ceasing to treat the local dimension as a disturbing element in formal systems but, on the contrary, taking note of its impact and unavoidability in actual practice.

Evidence-Based Medicine in Ophthalmic Journals During Covid-19 Pandemic.

BackgroundCOVID-19 has erupted into our lives and forced rapid changes in all fields of medicine, causing a rush for publications that inevitably caused a shift away from the paradigm of evidence-based medicine (EBM). The objective of the present report is to assess and quantify this process.MethodsWe compared the levels of EBM of the publications in the ophthalmic literature on COVID-19 at the beginning of the pandemic and compared it to those of articles published the prior year during April 2019 for the three highest ranking journals in the field of comprehensive ophthalmology.ResultsCOVID-19 publications ranked significantly lower (p<0.001). Time between submission and acceptance was significantly shorter for the COVID-19 publications (p<0.001), and significantly more publications were accepted without revisions (P<0.001).ConclusionThough a shift away from EBM may be unavoidable in the early stages of a pandemic, we suggest that for the benefit of reliable information and informed decision-making, it is time to go back to EBM.

Application of the Health Technology Assessment in Korean Traditional Medicines.

Background: South Korea is the first Asian country to adopt health technology assessment (HTA) as a tool to support decision-making concerning pricing and reimbursement of drugs in 2007. Korean traditional medicines have been continuously marginalized in the modern paradigm of evidence-based medicine. To nurture Korean medicines, clinical practice guidelines for Korean medicines have been developed through government-led initiatives, and HTAs have been applied for the National Health Insurance coverage of Korean medicines. In this study, 27 diseases were selected for analyzing the evidence development of both clinical and economic values of Korean medicines. Methods: To investigate the status quo in application of HTA in Korean medicines, reports on the cost-effectiveness analysis project comprising 27 Korean medical interventions were reviewed. Results: All the selected studies were trial-based economic appraisals and their effectiveness was estimated with a subjective judgment tool, such as the quality of life measurement or visual analog scale. This study reconfirmed the limitations of Korean medicines, which included a short observation period, nonrandomized controlled trials, small sample size, subjective assessment for efficacy, selection bias, large uncertainty, and lack of evidence. Conclusions: Priorities should be placed on establishing the clinical evidence of Korean medicines, which will serve as the base for expanding the health coverage of Korean medicines and improving satisfaction and reliability of oriental medicines in Korea's health care system. Furthermore, the need to nurture the institutional environment in which both oriental and Western medicines can collaborate in Korea should be emphasized.

Deferring Elective Urologic Surgery During the COVID-19 Pandemic: The Patients’ Perspective

OBJECTIVESTo explore the perspective of urological patients on the possibility to defer elective surgery due to the fear of contracting COVID-19.METHODSAll patients scheduled for elective urological procedures for malignant or benign diseases at 2 high-volume centers were administered a questionnaire, through structured telephone interviews, between April 24 and 27, 2020. The questionnaire included 3 questions: (1) In light of the COVID-19 pandemic, would you defer the planned surgical intervention? (2) If yes, when would you be willing to undergo surgery? (3) What do you consider potentially more harmful for your health: the risk of contracting COVID-19 during hospitalization or the potential consequences of delaying surgical treatment?RESULTSOverall, 332 patients were included (51.5% and 48.5% in the oncology and benign groups, respectively). Of these, 47.9% patients would have deferred the planned intervention (33.3% vs 63.4%; P < .001), while the proportion of patients who would have preferred to delay surgery for more than 6 months was comparable between the groups (87% vs 80%). These answers were influenced by patient age and American Society of Anesthesiologists score (in the Oncology group) and by the underlying urological condition (in the benign group). Finally, 182 (54.8%) patients considered the risk of COVID-19 potentially more harmful than the risk of delaying surgery (37% vs 73%; P < .001). This answer was driven by patient age and the underlying disease in both groups.CONCLUSIONSOur findings reinforce the importance of shared decision-making before urological surgery, leveraging patients’ values and expectations to refine the paradigm of evidence-based medicine during the COVID-19 pandemic and beyond.

Clinical practice guidelines in pediatric anesthesia: What constitutes high‐quality guidance?

The explosion of scientific evidence has outstripped the ability of individual clinicians to acquire, process, and apply it within a clinical context. Clinical practice guidelines bridge the gap between this large body of evidence and clinical practice by translating evidence into recommendations. As such, they are an important extension of the evidence-based medicine paradigm. Guidelines promise to translate evidence into actionable clinical recommendations. However, this promise can only be realized if they are both useful and trustworthy. As the number of guidelines increases users' question their role, the quality of the scientific evidence behind them and the strength of the recommendations made. In this article, we provide definitions and outline the features of the common forms of clinical guidance. We then describe the essential characteristics of good quality clinical guidance and outline initiatives aimed at improving quality. Specific issues and limitations related to guideline development in perioperative care of children are discussed. Finally, two clinical guidance documents, published recently in Pediatric Anesthesia, are discussed based upon these criteria.