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BACKGROUND: Myxomatous mitral valve degeneration is the most common canine heart disease. Several clinical trials have investigated various treatments. The latest recommendations are published in the ACVIM consensus guidelines (2019). Our study aimed to investigate how closely veterinary practitioners apply the treatment recommendations of these guidelines and the latest clinical trials.METHODS: An online survey was sent to Dutch and Belgian veterinary practices via digital channels.RESULTS: The data from 363 fully completed surveys were analyzed. For stage B1 disease, 93% recommended, correctly, no treatment. For stage B2 disease, 67% of the respondents recommended starting pimobendan as monotherapy. For chronic treatment of stage C disease, 16 different drug combinations were mentioned, but nobody recommended surgery. Only 48% of the respondents recommended the only evidence-based drug combination: a loop diuretic with pimobendan. A concerning finding was the simultaneous prescription of two loop diuretics, by 19% of the respondents.CONCLUSIONS: Treatment recommendations showed an increasing variation with more advanced disease stages from B1 through B2 to C. This reflects the increasing disagreement among the panelists who prepared the ACVIM consensus guidelines. Practitioners of our study seem to practice more evidence-based medicine than veterinary cardiologists, as it was reported in a recent survey-based study.

Introduction: Evidence-based medicine (EBM) is a critical skill for physicians, and EBM competency has been shown to increase implementation of best medical practices, reduce medical errors, and increase patient-centered care. Like any skill, EBM must be practiced, receiving iterative feedback to improve learners’ comprehension. Having residents document patient interactions in logbooks to allow for residency program review, feedback, and documentation of competency has been previously described as a best practice within emergency medicine (EM) to document practice-based learning (PBL) competency. Quantifying how residents use the information they query, locate, evaluate, and apply while providing direct patient care can measure the efficacy of EBM education and provide insight into more efficient ways of providing medical care. Methods: Practice-based learning logs were surveys created to record resident EBM activity on-shift and were placed into our residency management software program. Residents were required to submit 3–5 surveys of EBM activity performed during a 28-day rotation during which additional information was sought. This study included all PBL logs completed by EM residents from June 1, 2013–May 11, 2020. Using qualitative methodology, a codebook was created to analyze residents’ free-text responses to the prompt: “Based on your research, would you have done anything differently?” The codebook was designed to generate a three-digit code conveying the effect of the researched information on the patient about whom the log was written, as well as whether the information would affect future patient care and whether these decisions were based on scientific evidence. Results: A total of 10,574 logs were included for primary analysis. In total, 1,977 (18.7%) logs indicated that the evidence acquired through research would affect future patient care. Of these, 392 (3.7%) explicitly stated that the EBM activity conducted as part of our project led to real-time c

ObjectiveTo describe the methodology used by the Reassessment Campaign on Veterinary Resuscitation (RECOVER) to re-evaluate the scientific evidence relevant to CPR in small and large animals, to newborn resuscitation, and to first aid and to formulate the respective consensus-based clinical guidelines.DesignThis report describes the evidence-to-guidelines process employed by RECOVER that is based on the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach and includes Information Specialist-driven systematic literature search, evidence evaluation conducted by more than 200 veterinary professionals, and provision of clinical guidelines in the domains of Preparedness and Prevention, Basic Life Support, Advanced Life Support, Post-cardiac Arrest Care, Newborn Resuscitation, First Aid, and Large Animal CPR.SettingTransdisciplinary, international collaboration in academia, referral practice, and general practice.ResultsFor this update to the RECOVER 2012 CPR guidelines, we answered 135 Population, Intervention, Comparator, and Outcome (PICO) questions with the help of a team of Domain Chairs, Information Specialists, and more than 200 Evidence Evaluators. Most primary contributors were veterinary specialists or veterinary technician specialists. The RECOVER 2024 Guidelines represent the first veterinary application of the GRADE approach to clinical guideline development. We employed an iterative process that follows a predefined sequence of steps designed to reduce bias of Evidence Evaluators and to increase the repeatability of the quality of evidence assessments and ultimately the treatment recommendations. The process also allowed numerous important knowledge gaps to emerge that form the foundation for prioritizing research efforts in veterinary resuscitation science.ConclusionsLarge collaborative, volunteer-based development of evidence- and consensus-based clinical guidelines is challenging and complex but feasible. The experience gain

ObjectiveAfter the 2012 Reassessment Campaign on Veterinary Resuscitation (RECOVER) CPR Guidelines, this is an update of evidence-based consensus guidelines for Basic Life Support (BLS), advanced life support (ALS), and periarrest monitoring.DesignThese RECOVER CPR Guidelines were generated using a modified version of the Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) system for evidence evaluation and translation of this evidence into clear and actionable clinical instructions. Prioritized clinical questions in the Population, Intervention, Comparator, and Outcome (PICO) format were used as the basis to conduct systematic literature searches by information specialists, to extract information from relevant publications, to assess this evidence for quality, and finally to translate the findings into treatment recommendations. These recommendations were reviewed by the RECOVER writing group and opened for comment by veterinary professionals for 4 weeks.SettingTransdisciplinary, international collaboration in university, specialty, and emergency practice.ResultsA total of 40 worksheets were prepared to evaluate questions across the 3 domains of BLS, ALS and Monitoring, resulting in 90 individual treatment recommendations. High-dose epinephrine is no longer recommended, and atropine, if used, is only administered once. Bag-mask ventilation is prioritized over mouth-to-nose ventilation in nonintubated animals. In addition, an algorithm for initial assessment, an updated CPR algorithm, a rhythm diagnosis tool, and an updated drug dosing table are provided.ConclusionsWhile the majority of the BLS and ALS recommendations remain unchanged, some noteworthy changes were made due to new evidence that emerged over the past 10 years. Indirectness of evidence remains the largest impediment to the certainty of guidelines formulation and underscores an urgent need for more studies in the target species of dogs and cats.

ObjectiveTo systematically review evidence and devise treatment recommendations for basic life support (BLS) in dogs and cats and to identify critical knowledge gaps.DesignStandardized, systematic evaluation of literature pertinent to BLS following Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Prioritized questions were each reviewed by 2 Evidence Evaluators, and findings were reconciled by BLS Domain Chairs and Reassessment Campaign on Veterinary Resuscitation (RECOVER) Co-Chairs to arrive at treatment recommendations commensurate to quality of evidence, risk to benefit relationship, and clinical feasibility. This process was implemented using an Evidence Profile Worksheet for each question that included an introduction, consensus on science, treatment recommendations, justification for these recommendations, and important knowledge gaps. A draft of these worksheets was distributed to veterinary professionals for comment for 4 weeks prior to finalization.SettingTransdisciplinary, international collaboration in university, specialty, and emergency practice.ResultsTwenty questions regarding animal position, chest compression point and technique, ventilation strategies, as well as the duration of CPR cycles and chest compression pauses were examined, and 32 treatment recommendations were formulated. Out of these, 25 addressed chest compressions and 7 informed ventilation during CPR. The recommendations were founded predominantly on very low quality of evidence and expert opinion. These new treatment recommendations continue to emphasize the critical importance of high-quality, uninterrupted chest compressions, with a modification suggested for the chest compression technique in wide-chested dogs. When intubation is not possible, bag-mask ventilation using a tight-fitting facemask with oxygen supplementation is recommended rather than mouth-to-nose ventilation.ConclusionsThese updated RECOVER BLS treatment recommendations

ObjectiveTo systematically review the evidence and devise clinical recommendations on advanced life support (ALS) in dogs and cats and to identify critical knowledge gaps.DesignStandardized, systematic evaluation of literature pertinent to ALS following Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) methodology. Prioritized questions were each reviewed by Evidence Evaluators, and findings were reconciled by ALS Domain Chairs and Reassessment Campaign on Veterinary Resuscitation (RECOVER) Co-Chairs to arrive at treatment recommendations commensurate to quality of evidence, risk:benefit relationship, and clinical feasibility. This process was implemented using an Evidence Profile Worksheet for each question that included an introduction, consensus on science, treatment recommendations, justification for these recommendations, and important knowledge gaps. A draft of these worksheets was distributed to veterinary professionals for comment for 4 weeks prior to finalization.SettingTransdisciplinary, international collaboration in university, specialty, and emergency practice.ResultsSeventeen questions pertaining to vascular access, vasopressors in shockable and nonshockable rhythms, anticholinergics, defibrillation, antiarrhythmics, and adjunct drug therapy as well as open-chest CPR were reviewed. Of the 33 treatment recommendations formulated, 6 recommendations addressed the management of patients with nonshockable arrest rhythms, 10 addressed shockable rhythms, and 6 provided guidance on open-chest CPR. We recommend against high-dose epinephrine even after prolonged CPR and suggest that atropine, when indicated, is used only once. In animals with a shockable rhythm in which initial defibrillation was unsuccessful, we recommend doubling the defibrillator dose once and suggest vasopressin (or epinephrine if vasopressin is not available), esmolol, lidocaine in dogs, and/or amiodarone in cats.ConclusionsThese updated RECOVER ALS guidelines

The evidence underlying the use of advanced diagnostic imaging is based mainly on diagnostic accuracy studies and not on well-designed trials demonstrating improved patient outcomes. This has led to an expansion of low-value and potentially harmful patient care and raises ethical issues around the widespread implementation of tests with incompletely known benefits and harms. Randomized clinical trials are needed to support the safety and effectiveness of imaging tests and should be required for clearance of most new technologies. Large, diverse cohort studies are needed to quantify disease risk associated with many imaging findings, especially incidental findings, to enable evidence-based management. The responsibility to minimize the use of tests with unknown or low value requires engagement of clinicians, medical societies, and the public.

Objectives: The aim of this paper is to present the development of a longitudinal curriculum for medical students that is rooted in the particularity of the medical sciences and that aims to build and strengthen medical students' scientific skills and use thereof in clinical practice. Methods: The curriculum development was initiated based on students' feedback on the initial curriculum. To improve and expand the curriculum appropriately, a needs assessment, a literature review to define science specific to the medical sciences and practice, and an analysis of national and international curricula were performed. The curriculum development followed the PDCA cycle (Plan-Do-Check-Act).Results: The curriculum extends across the entire medical study programme from semesters 1 to 10. It consists of the seminar series on basic conduct and the epistemological groundings of science, scientific methods in medical research and health sciences, statistics and the scientific internship. Up to the sixth semester, the focus is on the acquisition of skills and abilities to work on and carry out a concrete research project; starting in semester seven, the critical evaluation and application of research results in everyday clinical practice are introduced. The curriculum is taught by epidemiologists, anthropologists, statisticians and public health scholars. Starting in semester seven, seminars are generally taught together with clinicians as tandem teaching. The curriculum is regularly assessed and adjusted. Conclusions: The Brandenburg Scientific Curriculum can be seen as a model of a longitudinal curriculum to teach scientific thinking and acting. One that is at the same time highly integrated in the medical curriculum overall. A central coordination point seems to be necessary to coordinate the teaching content and to ensure that teachers are interconnected. Furthermore, a complex curriculum in scientific methodology requires a set of teachers from a range of disciplinary backgro, Zielsetzung: Ziel dieses Beitrags ist die Entwicklung eines longitudinalen Curriculums für Medizinstudierende vorzustellen, das darauf abzielt, die wissenschaftlichen Kompetenzen der Medizinstudierenden zu entwickeln und zu stärken und diese in der klinischen Praxis unter Berücksichtigung der Besonderheiten der medizinischen Wissenschaften anzuwenden.Methoden: Die Entwicklung des Curriculums wurde auf der Grundlage des Feedbacks der Studierenden zum ursprünglichen Curriculum eingeleitet. Um das Curriculum entsprechend zu verbessern und zu erweitern, wurden eine Bedarfsanalyse, eine Literaturrecherche zur Definition von medizinischer Wissenschaft und Praxis sowie eine Analyse nationaler und internationaler Curricula durchgeführt. Die Entwicklung des Curriculums folgte dem PDCA-Zyklus (Plan-Do-Check-Act). Ergebnisse: Das Curriculum erstreckt sich über das gesamte Medizinstudium vom ersten bis zum zehnten Semester und besteht aus den Seminarreihen zu den Grundlagen der Wissenschaft und Erkenntnistheorie sowie Methoden Wissenschaftlichen Arbeitens und den Modulen Biometrie sowie Wissenschaftspraktikum. Bis zum sechsten Semester steht der Erwerb von Fähigkeiten und Fertigkeiten zur Bearbeitung und Durchführung eines konkreten Forschungsprojektes im Vordergrund, ab dem siebten Semester wird in die kritische Bewertung und Anwendung von Forschungsergebnissen im klinischen Alltag eingeführt. Das Curriculum wird von Epidemiolog*innen, Anthropolog*innen, Statistiker*innen und Public Health Wissenschaftler*innen unterrichtet. Ab dem siebten Semester werden die Seminare in der Regel gemeinsam mit Kliniker*innen im Tandem unterrichtet. Das Curriculum wird regelmäßig evaluiert und angepasst.Schlussfolgerung: Das Brandenburger Wissenschaftscurriculum kann als Modell eines longitudinalen Curriculums zur Vermittlung des wissenschaftlichen Denkens und Handelns angesehen werden. Ein Curriculum, das gleichzeitig in hohem Maße in das medizinische Curriculum insgesamt integriert ist. Eine

The working group Evidence-Based Medicine (AG-EBM) of the German Medical Library Association (AGMB) celebrates its fifth anniversary in 2024. It continues its work in the years 2023 and 2024 in the form of virtual meetings. The group meeting of the AG-EBM at the annual conference of the AGMB 2024 in Mainz provides an opportunity to get in touch with the group and its members., Die Arbeitsgemeinschaft Evidenzbasierte Medizin (AG-EBM) der Arbeitsgemeinschaft für Medizinisches Bibliothekswesen (AGMB) feiert im Jahr 2024 ihr fünfjähriges Bestehen. In den Jahren 2023 und 2024 setzt sie ihre Arbeit in virtuellen Fortbildungsmeetings fort. Auf der Jahrestagung der AGMB 2024 in Mainz wird wie die Jahre zuvor ein Treffpunkt stattfinden, der allen Interessierten die Gelegenheit gibt, sich über die Arbeit der AG zu informieren und auszutauschen.

Over the last decade or more, there have been increasing efforts to evaluate and improve the transparency of scholarly research across many fields of science. Part of these efforts include lobbying for greater investment in data stewardship, as well as increased public and private access to researchers’ data. In the context of cancer research, this would bring numerous benefits to the research community. For example, greater access to data provides researchers with opportunities to validate discovered findings, answer questions not originally considered by the data creators, and accelerate research through the synthesis of existing datasets. However, transparency also brings challenges, such as the navigation of privacy legislation, increased demands on time and resources, development of infrastructure and expertise, and substantial concerns among researchers such as fears about misinterpretation and misuse of shared data. In this thesis, I present research from five empirical studies that have explored the state of data sharing in oncology. These constitute Chapters 2 to 7. In Chapter 2, I report findings from a survey of journal editors, observing that journals report a wide variety of policies and practices on peer review and data sharing; even within different disciplines, norms are far from fixed. In Chapters 3 and 4, I present the protocol and the findings of a systematic review and individual participant data meta-analysis of over 2.1 million medical publications. At the end of these studies, I estimate that only 8% of medical articles published between 2016 and 2021 declared that the data were publicly available, and only 2% actually shared data. I also estimate that only a third of researchers comply with mandatory data sharing policies of journals, and even fewer – only a fifth – comply with policies requiring researchers to share with others on request. In Chapter 5, I narrow my focus down to data sharing in oncology research, and report that while one in

BACKGROUND: To bring evidence-based interventions (EBIs) to individuals with behavioral health needs, psychosocial interventions must be delivered at scale. Despite an increasing effort to implement effective treatments in communities, most individuals with mental health and behavioral problems do not receive EBIs. We posit that organizations that commercialize EBIs play an important role in disseminating EBIs, particularly in the USA. The behavioral health and implementation industry is growing, bringing the implementation field to an important inflection point: how to scale interventions to improve access while maintaining EBI effectiveness and minimizing inequities in access to psychosocial intervention. MAIN BODY: We offer a first-hand examination of five illustrative organizations specializing in EBI implementation: Beck Institute for Cognitive Behavioral Therapy; Incredible Years, Inc.; the PAXIS Institute; PracticeWise, LLC; and Triple P International. We use the Five Stages of Small Business Growth framework to organize themes. We discuss practical structures (e.g., corporate structures, intellectual property agreements, and business models) and considerations that arise when trying to scale EBIs including balancing fidelity and reach of the intervention. Business models consider who will pay for EBI implementation and allow organizations to scale EBIs. CONCLUSION: We propose research questions to guide scaling: understanding the level of fidelity needed to maintain efficacy, optimizing training outcomes, and researching business models to enable organizations to scale EBIs.

Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I-2 = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.

Medication adherence is a key precondition of the effectiveness of evidence-based therapies. However, in real-life settings, non-adherence to medication is still very common. This leads to profound health and economic consequences at both individual and public health levels. The problem of non-adherence has been extensively studied in the last 50 years. Unfortunately, with more than 130,000 scientific papers published on that subject so far, we are still far from finding an ultimate solution. This is, at least partly, due to fragmented and poor-quality research that has been conducted in this field sometimes. To overcome this deadlock, there is a need to stimulate the adoption of best practices in medication adherence-related research in a systematic way. Therefore, herein we propose the establishment of dedicated medication adherence research Centres of Excellence (CoEs). These Centres could not only conduct research but could also create a profound societal impact, directly serving the needs of patients, healthcare providers, systems and economies. Additionally, they could play a role as local advocates for good practices and education. In this paper, we propose some practical steps that might be taken in order to establish such CoEs. We describe two success stories, i.e., Dutch and Polish Medication Adherence Research CoEs. The COST Action "European Network to Advance Best practices & technoLogy on medication adherencE" (ENABLE) aims to develop a detailed definition of the Medication Adherence Research CoE in the form of a list of minimal requirements regarding their objectives, structure and activities. We hope that it will help to create a critical mass and catalyse the setup of regional and national Medication Adherence Research CoEs in the near future. This, in turn, may not only increase the quality of the research but also raise the awareness of non-adherence and promote the adoption of the best medication adherence-enhancing interventions.

Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I-2 = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.

Medication adherence is a key precondition of the effectiveness of evidence-based therapies. However, in real-life settings, non-adherence to medication is still very common. This leads to profound health and economic consequences at both individual and public health levels. The problem of non-adherence has been extensively studied in the last 50 years. Unfortunately, with more than 130,000 scientific papers published on that subject so far, we are still far from finding an ultimate solution. This is, at least partly, due to fragmented and poor-quality research that has been conducted in this field sometimes. To overcome this deadlock, there is a need to stimulate the adoption of best practices in medication adherence-related research in a systematic way. Therefore, herein we propose the establishment of dedicated medication adherence research Centres of Excellence (CoEs). These Centres could not only conduct research but could also create a profound societal impact, directly serving the needs of patients, healthcare providers, systems and economies. Additionally, they could play a role as local advocates for good practices and education. In this paper, we propose some practical steps that might be taken in order to establish such CoEs. We describe two success stories, i.e., Dutch and Polish Medication Adherence Research CoEs. The COST Action "European Network to Advance Best practices & technoLogy on medication adherencE" (ENABLE) aims to develop a detailed definition of the Medication Adherence Research CoE in the form of a list of minimal requirements regarding their objectives, structure and activities. We hope that it will help to create a critical mass and catalyse the setup of regional and national Medication Adherence Research CoEs in the near future. This, in turn, may not only increase the quality of the research but also raise the awareness of non-adherence and promote the adoption of the best medication adherence-enhancing interventions.

This issue focuses on the topic of "Research-related services of (medical) libraries". These include services for research data management, systematic literature searches and reviews in the context of evidence-based medicine, and other services related to the publication of research results. The current issue also contains reflections on ChatGPT in the medical library focus, the Medical Librarian's Bibliography 2022 as well as reports from the Working Group on Evidence-Based Medicine within AGMB (AG-EBM) and "German MLA (AGMB) News"., Das vorliegende Heft ist dem Schwerpunktthema "Forschungsnahe Dienste von (Medizin-)Bibliotheken" gewidmet. Dazu zählen Angebote zum Forschungsdatenmanagement, zu systematischen Literaturrecherchen und -arbeiten im Kontext der evidenzbasierten Medizin und weitere Services rund um das Veröffentlichen von Forschungsergebnissen. Die aktuelle Ausgabe enthält außerdem Überlegungen zu ChatGPT im medizinbibliothekarischen Fokus, die Medizinbibliothekarische Bibliografie 2022 sowie die Berichte aus der Arbeitsgruppe Evidenzbasierte Medizin der AGMB (AG-EBM) und "Aus der AGMB".

Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I-2 = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.

Medication adherence is a key precondition of the effectiveness of evidence-based therapies. However, in real-life settings, non-adherence to medication is still very common. This leads to profound health and economic consequences at both individual and public health levels. The problem of non-adherence has been extensively studied in the last 50 years. Unfortunately, with more than 130,000 scientific papers published on that subject so far, we are still far from finding an ultimate solution. This is, at least partly, due to fragmented and poor-quality research that has been conducted in this field sometimes. To overcome this deadlock, there is a need to stimulate the adoption of best practices in medication adherence-related research in a systematic way. Therefore, herein we propose the establishment of dedicated medication adherence research Centres of Excellence (CoEs). These Centres could not only conduct research but could also create a profound societal impact, directly serving the needs of patients, healthcare providers, systems and economies. Additionally, they could play a role as local advocates for good practices and education. In this paper, we propose some practical steps that might be taken in order to establish such CoEs. We describe two success stories, i.e., Dutch and Polish Medication Adherence Research CoEs. The COST Action "European Network to Advance Best practices & technoLogy on medication adherencE" (ENABLE) aims to develop a detailed definition of the Medication Adherence Research CoE in the form of a list of minimal requirements regarding their objectives, structure and activities. We hope that it will help to create a critical mass and catalyse the setup of regional and national Medication Adherence Research CoEs in the near future. This, in turn, may not only increase the quality of the research but also raise the awareness of non-adherence and promote the adoption of the best medication adherence-enhancing interventions.

BACKGROUND: Interventional radiology (IR) and interventional endoscopy (IE) have broad potential for minimally invasive therapy in veterinary patients, but the scope of original peer-reviewed veterinary IR/IE research publications has not been described. OBJECTIVES: Catalogue published applications and indications for noncardiac therapeutic IR/IE in animals and describe type and quality of veterinary IR/IE research over 20 years. METHODS: Highly-cited veterinary journals were searched to identify articles published 2000 to 2019 involving therapeutic IR/IE applications for clinical veterinary patients. Articles were assigned a level of evidence (LOE) according to published standards. Authorship, animal data, study design, and interventions were described. Change in publication rate, study size, and LOE of IR/IE articles over time was analyzed. RESULTS: One hundred fifty-nine of 15 512 (1%) articles were eligible, including 2972 animals. All studies were low LOE and 43% were case reports with ≤5 animals. Number of IR/IE articles per year (P < .001), proportion of journals articles pertaining to IR/IE (P = .02), and study size (P = .04) all increased over time, but LOE (P = .07) did not. Common target body systems were urinary (40%), digestive (23%) respiratory (20%), and vascular (13%). Common indications were nonvascular luminal obstructions (47%), object retrieval (14%), and congenital anomalies (13%). Most procedures involved indwelling medical devices or embolic agents, whereas tissue resection and other procedures were less common. Procedures utilized fluoroscopy (43%), endoscopy (33%), ultrasound (8%), digital radiography (1%), or fluoroscopy in combination with other modalities (16%). CONCLUSIONS: Treatments involving IR/IE have wide applicability in veterinary medicine but large, rigorous, and comparative studies describing these procedures are lacking.

BACKGROUND: The DYNAMIC trial investigated the use of circulating tumor DNA (ctDNA) to guide adjuvant treatment decisions in stage II colon cancer. Despite the DYNAMIC trials assertion that a ctDNA-guided approach could minimize the use of adjuvant treatment without compromising recurrence-free survival (RFS), we raised concerns regarding the trials methodology and the practical implications of its findings in a Debate article. Here, we expand upon these concerns in a response to a correspondence by the authors of the DYNAMIC trial. MAIN BODY: We dispute the choice of a large non-inferiority margin in the DYNAMIC trial, simply because an 8.5 percentage points decrease in recurrence-free survival could result in significant harm to patients. We challenge the authors comparisons of the DYNAMIC trial outcomes with observational studies. Such comparison is subject to selection bias and changes over time that limit their relevance. The prognostic role of ctDNA do not automatically imply that more treatment in patients with ctDNA positivity would improve outcomes, which we highlight. In real-world settings, we anticipate a potential rise in chemotherapy use due to clinicians utilizing ctDNA alongside existing clinicopathologic factors, rather than using ctDNA as an entire replacement. Lastly, a key concern in DYNAMIC was an 350% higher use of oxaliplatin in the ctDNA arm compared with standard management (9.5% versus 2.7%, respectively), which poses a risk for long-term neuropathy. CONCLUSION: We look forward improvements in patient selection in the adjuvant setting, but we maintain our reservations about the DYNAMIC trial and the real-life implementation of its results. As an alternative to exploring de-escalation strategies with large margins non-inferiority trials, we propose that superiority trials in stage II patients could be a more effective strategy.

Primary biliary cholangitis (PBC) is a chronic, cholestatic, autoimmune liver disease that can progress to end-stage liver disease and its complications. A previous expert review panel collaborated on a consensus document for gastroenterologists and other healthcare professionals regarding the care of patients with PBC. Subsequently, there have been several recent important developments in the diagnosis, treatment, and monitoring of patients with PBC. These include updates to prognostic models on risk stratification, new noninvasive tools for staging of disease, updates to the appropriate use of and long-term treatment results with obeticholic acid as a second-line treatment, the emerging therapeutic role of fibrates, and the advancement of investigational agents for managing PBC. In this updated expert consensus document, we provide updates on staging, the use of noninvasive prognostic tools, and a treatment algorithm to provide evidence-based and practical tools for clinicians who manage PBC, with the ultimate goal to improve the long-term outcomes for patients with this chronic liver disease.

Medication adherence is a key precondition of the effectiveness of evidence-based therapies. However, in real-life settings, non-adherence to medication is still very common. This leads to profound health and economic consequences at both individual and public health levels. The problem of non-adherence has been extensively studied in the last 50 years. Unfortunately, with more than 130,000 scientific papers published on that subject so far, we are still far from finding an ultimate solution. This is, at least partly, due to fragmented and poor-quality research that has been conducted in this field sometimes. To overcome this deadlock, there is a need to stimulate the adoption of best practices in medication adherence-related research in a systematic way. Therefore, herein we propose the establishment of dedicated medication adherence research Centres of Excellence (CoEs). These Centres could not only conduct research but could also create a profound societal impact, directly serving the needs of patients, healthcare providers, systems and economies. Additionally, they could play a role as local advocates for good practices and education. In this paper, we propose some practical steps that might be taken in order to establish such CoEs. We describe two success stories, i.e., Dutch and Polish Medication Adherence Research CoEs. The COST Action "European Network to Advance Best practices & technoLogy on medication adherencE" (ENABLE) aims to develop a detailed definition of the Medication Adherence Research CoE in the form of a list of minimal requirements regarding their objectives, structure and activities. We hope that it will help to create a critical mass and catalyse the setup of regional and national Medication Adherence Research CoEs in the near future. This, in turn, may not only increase the quality of the research but also raise the awareness of non-adherence and promote the adoption of the best medication adherence-enhancing interventions.

Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I-2 = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.

Evidence-based obstetrics can employ statistical models to justify greater use of cesareans, sometimes excluding experiential elements from informed decision making. Over the past decade, prenatal providers adopted a vaginal birth after cesarean (VBAC) calculator designed to support patients in making informed decisions about their births by estimating their probability for a VBAC. Among other factors, the calculator used race and ethnicity to make its estimate, assigning lower probabilities for a successful VBAC to Black and Hispanic patients. I analyze how a diverse group of women and their providers engaged with the VBAC calculator. Some providers used low calculator scores to remove a shared decision-making model by prescriptively counseling Black and Hispanic women who desired a VBAC into undergoing repeat cesareans. Consequently, women racialized by the calculator as Black or Hispanic used experiential knowledge to challenge the calculator's assessment of their supposed lesser ability to give birth vaginally.

Introduction: The use of evidence-based techniques by students is a fundamental method for learning. Objective: To evaluate the frequency of the use of evidence-based study techniques in medical students from a university in Peru. Methods: A cross-sectional observational study was carried out with 75 students of human medicine from the National University of Central Peru through a survey that collected study techniques and other variables, selected by non-probabilistic sampling. Results: (58.73%) were male, one (58.7%), did not use evidence-based study techniques, low-medium family socioeconomic level (33.3%). The most used study material was books (58.14%), followed by scientific articles (24%); (45.3%) spent between 4-6 hours studying and (40%) used the "Active recall" technique. For their part, (53.3%) enjoyed studying "sometimes", (70.7%) postponed studying "sometimes" and (62.7%) had difficulty concentrating "sometimes". Furthermore, our findings indicate that those who studied for less than 2 hours preferred educational videos, while students who dedicated 6-8 hours chose to engage with reading books, scientific articles, and evidence-based slides. Similarly, those encountering difficulties 'most of the time' tended to overuse slides, whereas those facing difficulties 'always' favored educational videos (p<0.05). Discussion: The use of evidence-based techniques by human medicine students is still not the majority, only half maintain active use in their professional training, it is unknown or its implementation has a low level. Knowing these variables will make it possible to carry out schemes and educational talks in future professionals., Introducción: El uso de técnicas de estudio basada en evidencias por parte de los estudiantes constituye un método fundamental para el aprendizaje. Objetivo: Evaluar la frecuencia del uso de técnicas de estudio basadas en evidencia en estudiantes de medicina de una universidad en el Perú. Metodología: Se realizó un estudio observacional transversal con 75 estudiantes de medicina humana de la Universidad Nacional del Centro del Perú a través de una encuesta que recopilo las técnicas de estudio y otras variables, seleccionados mediante un muestreo no probabilístico. Resultados: El (58,73 %) fueron varones, un (58,7 %), no utilizó técnicas de estudio basadas en evidencia, nivel socioeconómico familiar bajo-medio (33,3 %). El material de estudio más utilizado fueron libros (58,14 %), seguido de artículos científicos (24 %); el (45,3 %) dedicaba entre 4-6 horas al estudio y el (40 %) usaba la técnica “Active recall”. Por su parte, el (53,3 %) disfrutaban del estudio “algunas veces”, (70,7 %) aplazaban el momento de estudiar “algunas veces” y el (62,7 %) tenían dificultad para concentrarse “algunas veces”. Además, encontramos que aquellos que estudiaron menos de 2 horas prefirieron videos educativos y los estudiantes que dedicaron 6-8 horas eligieron la lectura de libros, artículos científicos y diapositivas basadas en evidencias. Así mismo los que enfrentaron dificultades 'la mayoría del tiempo' tendieron a utilizar diapositivas en exceso, mientras que los que enfrentaron dificultades 'siempre' prefirieron videos educativos (p<0,05). Discusión: El empleo de técnicas de estudio fundamentadas en evidencias por parte de los estudiantes aún no prevalece de manera mayoritaria. Solo la mitad de los estudiantes mantiene una utilización activa en su desarrollo profesional, mientras que existe desconocimiento y un nivel bajo de implementación. El entendimiento de estas variables brindará la oportunidad de establecer charlas educativas dirigidas a los futuros profesionales.

The purpose of this study is to determine the use of evidence-based practice among doctors in specialty training at Instituto Nacional del Niño-San Borja in Lima, Peru. (INSN-San Borja). A total of 200 doctors in paediatric specialty training were included in this cross-sectional study. The Health Sciences Evidence-Based Practice (HS-EBP) questionnaire was performed to assess the use of evidence-based clinical practices. The questionnaire has five dimensions: “Beliefs and attitudes” (D1), “Results from scientific research” (D2), “Development of professional practice” (D3), “Assessment of results” (D4), and “Barriers and facilitators” (D5). Each of the five HS-EBP questionnaire dimensions had a median score of 107, 107, 79, 88, and 77, respectively. The ranges of possible scores in each dimension were as follows: from 12 to 120 in D1, D4, and D5; from 14 to 140 in D2; and from 10 to 100 in D3. This study shows that doctors in specialty training at the INSN-San Borja obtained median scores over the mean of possible scores in each of those dimensions, with a lower score in D5 (Barriers and facilitators). This shows that these doctors use evidence-based practice, however they consider there are barriers for its application. According to our observations, the main barrier is the lack of available time due to other clinical commitments., El objetivo del estudio es determinar el uso de la práctica basada en evidencia entre los médicos en formación de especialidad en el Instituto Nacional del Niño-San Borja en Lima, Perú (INSN-San Borja). Es un estudio transversal y se incluyeron un total de 200 médicos en formación en la especialidad de pediatría. Se realizó el cuestionario Health Sciences Evidence-Based Practice (HS-EBP) para evaluar el uso de prácticas clínicas basadas en la evidencia. El cuestionario tiene cinco dimensiones: “Creencias y actitudes” (D1), “Resultados de la investigación científica” (D2), “Desarrollo de la práctica profesional” (D3), “Evaluación de resultados” (D4) y “Barreras y facilitadores” (D5). Cada una de las cinco dimensiones del cuestionario HS-EBP tuvo una puntuación media de 107, 107, 79, 88 y 77, respectivamente. Los rangos de puntajes posibles en cada dimensión fueron los siguientes: de 12 a 120 en D1, D4 y D5; de 14 a 140 en D2; y de 10 a 100 en D3. Este estudio muestra que los médicos en formación de la especialidad en el INSN-San Borja obtuvieron puntuaciones sobre la media de las puntuaciones posibles en cada una de esas dimensiones, con una puntuación inferior en D5 (Barreras y facilitadores). Esto demuestra que estos médicos utilizan la práctica basada en la evidencia, sin embargo, consideran que existen barreras para su aplicación. Según nuestras observaciones, la principal barrera es la falta de tiempo disponible debido a otros compromisos clínicos.

Mindfulness and compassion meditation is a popular lifestyle intervention in randomised controlled clinical trials (RCTs), which examine its efficacy to ameliorate health and well-being. Studying meditation in an RCT poses the challenge of standardising an intervention that relies on a mix of people, skills and activities. This article describes how, in meeting this challenge, researchers engage in diverging knowledge-making practices. It draws on praxiographic inquiry in an RCT on the effects of meditation compared to a foreign language training on healthy ageing. To analyse normative dimensions of knowledge-making practices, the concept of ‘epistemic goods’ is introduced. Researchers juggled partly incoherent epistemic goods—internal validity, social relevance, assessing efficacy, attending to qualitative effects, objectivity, trained judgment—and resolved tensions between them. Strate- gies to respond to unexpected events in the research process were: reinterpreting the study protocol, caring informally while playing by formal rules and adjusting the procedure of a study task. Analysing epistemic goods and strategies that make them coexist is relevant to problematise what counts as evidence in evidence-based medicine. Instead of evaluating knowledge by reference to a ‘gold standard’, evidence claims should be placed in the context of their production to evaluate them on their own terms.

The purpose of this study is to determine the use of evidence-based practice among doctors in specialty training at Instituto Nacional del Niño-San Borja in Lima, Peru. (INSN-San Borja). A total of 200 doctors in paediatric specialty training were included in this cross-sectional study. The Health Sciences Evidence-Based Practice (HS-EBP) questionnaire was performed to assess the use of evidence-based clinical practices. The questionnaire has five dimensions: “Beliefs and attitudes” (D1), “Results from scientific research” (D2), “Development of professional practice” (D3), “Assessment of results” (D4), and “Barriers and facilitators” (D5). Each of the five HS-EBP questionnaire dimensions had a median score of 107, 107, 79, 88, and 77, respectively. The ranges of possible scores in each dimension were as follows: from 12 to 120 in D1, D4, and D5; from 14 to 140 in D2; and from 10 to 100 in D3. This study shows that doctors in specialty training at the INSN-San Borja obtained median scores over the mean of possible scores in each of those dimensions, with a lower score in D5 (Barriers and facilitators). This shows that these doctors use evidence-based practice, however they consider there are barriers for its application. According to our observations, the main barrier is the lack of available time due to other clinical commitments., El objetivo del estudio es determinar el uso de la práctica basada en evidencia entre los médicos en formación de especialidad en el Instituto Nacional del Niño-San Borja en Lima, Perú (INSN-San Borja). Es un estudio transversal y se incluyeron un total de 200 médicos en formación en la especialidad de pediatría. Se realizó el cuestionario Health Sciences Evidence-Based Practice (HS-EBP) para evaluar el uso de prácticas clínicas basadas en la evidencia. El cuestionario tiene cinco dimensiones: “Creencias y actitudes” (D1), “Resultados de la investigación científica” (D2), “Desarrollo de la práctica profesional” (D3), “Evaluación de resultados” (D4) y “Barreras y facilitadores” (D5). Cada una de las cinco dimensiones del cuestionario HS-EBP tuvo una puntuación media de 107, 107, 79, 88 y 77, respectivamente. Los rangos de puntajes posibles en cada dimensión fueron los siguientes: de 12 a 120 en D1, D4 y D5; de 14 a 140 en D2; y de 10 a 100 en D3. Este estudio muestra que los médicos en formación de la especialidad en el INSN-San Borja obtuvieron puntuaciones sobre la media de las puntuaciones posibles en cada una de esas dimensiones, con una puntuación inferior en D5 (Barreras y facilitadores). Esto demuestra que estos médicos utilizan la práctica basada en la evidencia, sin embargo, consideran que existen barreras para su aplicación. Según nuestras observaciones, la principal barrera es la falta de tiempo disponible debido a otros compromisos clínicos.

[ES] Objetivo: Proporcionar recomendaciones prácticas para el abordaje integral de las personas con diabetes tipo 2 según la medicina basada en la evidencia. Participantes: Miembros del Área de Conocimiento de Diabetes de la Sociedad Española de Endocrinología y Nutrición. Métodos: Las recomendaciones se formularon según los grados de evidencia de los Standards of Medical Care in Diabetes—2022. Tras la revisión de la evidencia disponible y la formulación de recomendaciones por los autores de cada apartado, se desarrollaron varias rondas de comentarios con incorporación de las aportaciones y votación de los puntos controvertidos. Por último, el documento final se remitió al resto de los miembros del área para revisión e incorporación de aportaciones, para, finalmente, realizar el mismo proceso con los miembros de la Junta Directiva de la Sociedad Española de Endocrinología y Nutrición. Conclusiones: El documento establece unas recomendaciones prácticas basadas en la última evidencia disponible para el manejo de las personas con diabetes tipo 2., [EN] Objective. To provide practical recommendations for the comprehensive approach of people with type 2 diabetes according to evidence-based medicine. Participants. Members of the Diabetes Knowledge Area of the Spanish Society of Endocrinology and Nutrition. Methods. The recommendations were formulated according to the degrees of evidence of the Standards of Medical Care in Diabetes—2022. After reviewing the available evidence and formulating recommendations by the authors of each section, several rounds of comments were developed incorporating the contributions and voting on controversial points. Finally, the final document was sent to the rest of the members of the area for review and incorporation of contributions, to finally carry out the same process with the members of the Spanish Society of Endocrinology and Nutrition Board of Directors. Conclusions. The document establishes practical recommendations based on the latest available evidence for the management of people with type 2 diabetes.

Concerns have been raised that regulatory programs to accelerate approval of cancer drugs in cancer may increase uncertainty about benefits and harms for survival and quality of life (QoL). We analyzed all pivotal clinical trials and all non-pivotal randomized controlled trials (RCTs) for all cancer drugs approved for the first time by the FDA between 2000 and 2020. We report regulatory and trial characteristics. Effects on overall survival (OS), progression-free survival and tumor response were summarized in meta-analyses. Effects on QoL were qualitatively summarized. Between 2000 and 2020, the FDA approved 145 novel cancer drugs for 156 indications based on 190 clinical trials. Half of indications (49%) were approved without RCT evidence; 82% had a single clinical trial only. OS was primary endpoint in 14% of trials and QoL data were available from 25%. The median OS benefit was 2.55 months (IQR, 1.33-4.28) with a mean hazard ratio for OS of 0.75 (95%CI, 0.72-0.79, I-2 = 42). Improvement for QoL was reported for 7 (4%) of 156 indications. Over time, priority review was used increasingly and the mean number of trials per indication decreased from 1.45 to 1.12. More trials reported results on QoL (19% in 2000-2005; 41% in 2016-2020). For 21 years, novel cancer drugs have typically been approved based on one single, often uncontrolled, clinical trial, measuring surrogate endpoints. This leaves cancer patients without solid evidence that novel drugs improve their survival or QoL and there is no indication towards improvement.

Medication adherence is a key precondition of the effectiveness of evidence-based therapies. However, in real-life settings, non-adherence to medication is still very common. This leads to profound health and economic consequences at both individual and public health levels. The problem of non-adherence has been extensively studied in the last 50 years. Unfortunately, with more than 130,000 scientific papers published on that subject so far, we are still far from finding an ultimate solution. This is, at least partly, due to fragmented and poor-quality research that has been conducted in this field sometimes. To overcome this deadlock, there is a need to stimulate the adoption of best practices in medication adherence-related research in a systematic way. Therefore, herein we propose the establishment of dedicated medication adherence research Centres of Excellence (CoEs). These Centres could not only conduct research but could also create a profound societal impact, directly serving the needs of patients, healthcare providers, systems and economies. Additionally, they could play a role as local advocates for good practices and education. In this paper, we propose some practical steps that might be taken in order to establish such CoEs. We describe two success stories, i.e., Dutch and Polish Medication Adherence Research CoEs. The COST Action "European Network to Advance Best practices & technoLogy on medication adherencE" (ENABLE) aims to develop a detailed definition of the Medication Adherence Research CoE in the form of a list of minimal requirements regarding their objectives, structure and activities. We hope that it will help to create a critical mass and catalyse the setup of regional and national Medication Adherence Research CoEs in the near future. This, in turn, may not only increase the quality of the research but also raise the awareness of non-adherence and promote the adoption of the best medication adherence-enhancing interventions.

Background: Over the past decade, an industry has emerged around Clinical Practice Guideline (CPG) development in healthcare, which has increased pressure on guideline-producing organisations to develop CPGs at an accelerated rate. These are intended to improve the quality of care provided to patients while containing healthcare costs and reducing variability in clinical practice. However, this has inadvertently led to discrepancies in CPG recommendations between health organisations, also challenging healthcare providers who rely on these for decision-making and to inform clinical care. From a global perspective, although some countries have initiated national protocols regarding developing, appraising and implementing high-quality CPGs, there remains no standardised approach to any aspect of CPG production. Methods: A scoping review of the literature and document analysis were conducted according to Joanna Brigg’s Institute methodology for scoping reviews. This comprised two qualitative methods: a comprehensive review of the literature (using CINAHL, Scopus and PubMeD) and a document analysis of all national and international guideline development processes (manual search of health-related websites, national/international organisational health policies and documents). Results: A set of clear principles and processes were identified as crucial to CPG development, informing the planning, implementation and dissemination of recommendations. Fundamentally, two common goals were reported: to improve the quality and consistency of clinical practice (patient care) and to reduce the duplication or ratification of low-grade CPGs. Conclusions: Consultation and communication between CPG working parties, including a wide range of representatives (including professional organisations, regional and local offices, and relevant national bodies) is essential. Further research is required to establish the feasibility of standardising the approach and disseminating the recommendatio

Precision medicine is part of the logical evolution of contemporary evidence-based medicine that seeks to reduce errors and optimize outcomes when making medical decisions and health recommendations. Diabetes affects hundreds of millions of people worldwide, many of whom will develop life-threatening complications and die prematurely. Precision medicine can potentially address this enormous problem by accounting for heterogeneity in the etiology, clinical presentation and pathogenesis of common forms of diabetes and risks of complications. This second international consensus report on precision diabetes medicine summarizes the findings from a systematic evidence review across the key pillars of precision medicine (prevention, diagnosis, treatment, prognosis) in four recognized forms of diabetes (monogenic, gestational, type 1, type 2). These reviews address key questions about the translation of precision medicine research into practice. Although not complete, owing to the vast literature on this topic, they revealed opportunities for the immediate or near-term clinical implementation of precision diabetes medicine; furthermore, we expose important gaps in knowledge, focusing on the need to obtain new clinically relevant evidence. Gaps include the need for common standards for clinical readiness, including consideration of cost-effectiveness, health equity, predictive accuracy, liability and accessibility. Key milestones are outlined for the broad clinical implementation of precision diabetes medicine.

Background: Clinical Practice Guidelines (CPGs) provide healthcare professionals with performance and decision-making support during the treatment of patients. Sometimes, however, they are poorly implemented. The IDE4ICDS platform was developed and validated with CPGs for type 2 diabetes mellitus (T2DM). Objective: The main objective of this paper is to present the results of the clinical validation of the IDE4ICDS platform in a real clinical environment at two health clinics in the Andalusian Public Health System (SSPA) in the southern Spanish region of Andalusia. Methods: National and international knowledge sources on T2DM were selected and reviewed and used to define a diabetes CPG model on the IDE4ICDS platform. Once the diabetes CPG was configured and deployed, it was validated. A total of 506 patients were identified as meeting the inclusion criteria, of whom 130 could be recruited and 89 attended the appointment. Results: A concordance analysis was performed with the kappa value. Overall agreement between the recommendations provided by the system and those recorded in each patient's EHR was good (0.61 - 0.80) with a total kappa index of 0.701, leading to the conclusion that the system provided appropriate recommendations for each patient and was therefore well-functioning. Conclusions: A series of possible improvements were identified based on the limitations for the recovery of variables related to the quality of these recolected variables, the detection of duplicate recommendations based on different input variables for the same patient, and clinical usability, such as the capacity to generate reports based on the recommendations generated. Nevertheless, the project resulted in the IDE4ICDS platform: a Clinical Decision Support System (CDSS) capable of providing appropriate recommendations for improving the management and quality of patient care and optimizing health outcomes. The result of this validation is a safe and effective pathway for developing an

Progress in the field of insomnia since 2017 necessitated this update of the European Insomnia Guideline. Recommendations for the diagnostic procedure for insomnia and its comorbidities are: clinical interview (encompassing sleep and medical history); the use of sleep questionnaires and diaries (and physical examination and additional measures where indicated) (A). Actigraphy is not recommended for the routine evaluation of insomnia (C), but may be useful for differential-diagnostic purposes (A). Polysomnography should be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders, etc.), treatment-resistant insomnia (A) and for other indications (B). Cognitive-behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (including patients with comorbidities), either applied in-person or digitally (A). When cognitive-behavioural therapy for insomnia is not sufficiently effective, a pharmacological intervention can be offered (A). Benzodiazepines (A), benzodiazepine receptor agonists (A), daridorexant (A) and low-dose sedating antidepressants (B) can be used for the short-term treatment of insomnia (≤ 4 weeks). Longer-term treatment with these substances may be initiated in some cases, considering advantages and disadvantages (B). Orexin receptor antagonists can be used for periods of up to 3 months or longer in some cases (A). Prolonged-release melatonin can be used for up to 3 months in patients ≥ 55 years (B). Antihistaminergic drugs, antipsychotics, fast-release melatonin, ramelteon and phytotherapeutics are not recommended for insomnia treatment (A). Light therapy and exercise interventions may be useful as adjunct therapies to cognitive-behavioural therapy for insomnia (B)., Progress in the field of insomnia since 2017 necessitated this update of the European Insomnia Guideline. Recommendations for the diagnostic procedure for insomnia and its comorbidities are: clinical interview (encompassing sleep and medical history); the use of sleep questionnaires and diaries (and physical examination and additional measures where indicated) (A). Actigraphy is not recommended for the routine evaluation of insomnia (C), but may be useful for differential-diagnostic purposes (A). Polysomnography should be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders, etc.), treatment-resistant insomnia (A) and for other indications (B). Cognitive-behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (including patients with comorbidities), either applied in-person or digitally (A). When cognitive-behavioural therapy for insomnia is not sufficiently effective, a pharmacological intervention can be offered (A). Benzodiazepines (A), benzodiazepine receptor agonists (A), daridorexant (A) and low-dose sedating antidepressants (B) can be used for the short-term treatment of insomnia (≤ 4 weeks). Longer-term treatment with these substances may be initiated in some cases, considering advantages and disadvantages (B). Orexin receptor antagonists can be used for periods of up to 3 months or longer in some cases (A). Prolonged-release melatonin can be used for up to 3 months in patients ≥ 55 years (B). Antihistaminergic drugs, antipsychotics, fast-release melatonin, ramelteon and phytotherapeutics are not recommended for insomnia treatment (A). Light therapy and exercise interventions may be useful as adjunct therapies to cognitive-behavioural therapy for insomnia (B).

Background: Appendicitis is one of the most common surgical emergencies globally and it can both be difficult to diagnose but also to differentiate complicated from uncomplicated appendicitis preoperatively. The objective of this scoping review was to develop an overview of biomarkers in blood discriminating complicated from uncomplicated appendicitis and characterize their applicability in an acute setting including time, cost, and analysis technique required as well as their individual precision. Method: This scoping review was reported in accordance with PRISMA-ScR. The included studies had to report on biomarkers measured in the blood for at least ten patients with suspected appendicitis. A systematic literature search was conducted on August 28, 2022, in PubMed and Embase but restricted to articles published in January 2000 and onwards. A protocol was uploaded to Open Science Framework prior to data extraction. Results: A total of 65 biomarkers were included from 52 studies, covering 14,312 patients. There was 60% routine- and 40% novel biomarkers based on the reported analysis technique. The most frequently investigated biomarkers within each group were white blood cell count and procalcitonin. The routine biomarkers were of low financial cost but poor diagnostic accuracy with sensitivity ranging between 15 and 100% and specificity between 27 and 100%. Novel markers were costly ranging from 275 to 800$, and their diagnostic accuracy was based on limited population sizes (median 34 patients) and reported for only 5% of the novel markers. Conclusion: Routine biomarkers were applicable in an acute setting but had poor diagnostic accuracy. Novel biomarkers are being investigated for potential, but the concept is still premature due to lack of diagnostic accuracy studies reporting cost-benefit for individual markers and whether they can be applied in an acute setting.

Borderline personality disorder (BPD) is a highly studied condition. During the last 3 decades, the understanding of the disorder has substantially changed, based on thorough, accumulating research. At the same time, the interest in BPD is still not decreasing but continues to grow. This article aims to critically discuss research trends in clinical trials of personality disorders in general and BPD in particular, to highlight topics that deserve closer attention, and to give recommendations for the design and conduct of future psychotherapy or pharmacotherapy studies in the field.

Progress in the field of insomnia since 2017 necessitated this update of the European Insomnia Guideline. Recommendations for the diagnostic procedure for insomnia and its comorbidities are: clinical interview (encompassing sleep and medical history); the use of sleep questionnaires and diaries (and physical examination and additional measures where indicated) (A). Actigraphy is not recommended for the routine evaluation of insomnia (C), but may be useful for differential-diagnostic purposes (A). Polysomnography should be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders, etc.), treatment-resistant insomnia (A) and for other indications (B). Cognitive-behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (including patients with comorbidities), either applied in-person or digitally (A). When cognitive-behavioural therapy for insomnia is not sufficiently effective, a pharmacological intervention can be offered (A). Benzodiazepines (A), benzodiazepine receptor agonists (A), daridorexant (A) and low-dose sedating antidepressants (B) can be used for the short-term treatment of insomnia (≤ 4 weeks). Longer-term treatment with these substances may be initiated in some cases, considering advantages and disadvantages (B). Orexin receptor antagonists can be used for periods of up to 3 months or longer in some cases (A). Prolonged-release melatonin can be used for up to 3 months in patients ≥ 55 years (B). Antihistaminergic drugs, antipsychotics, fast-release melatonin, ramelteon and phytotherapeutics are not recommended for insomnia treatment (A). Light therapy and exercise interventions may be useful as adjunct therapies to cognitive-behavioural therapy for insomnia (B)., Progress in the field of insomnia since 2017 necessitated this update of the European Insomnia Guideline. Recommendations for the diagnostic procedure for insomnia and its comorbidities are: clinical interview (encompassing sleep and medical history); the use of sleep questionnaires and diaries (and physical examination and additional measures where indicated) (A). Actigraphy is not recommended for the routine evaluation of insomnia (C), but may be useful for differential-diagnostic purposes (A). Polysomnography should be used to evaluate other sleep disorders if suspected (i.e. periodic limb movement disorder, sleep-related breathing disorders, etc.), treatment-resistant insomnia (A) and for other indications (B). Cognitive-behavioural therapy for insomnia is recommended as the first-line treatment for chronic insomnia in adults of any age (including patients with comorbidities), either applied in-person or digitally (A). When cognitive-behavioural therapy for insomnia is not sufficiently effective, a pharmacological intervention can be offered (A). Benzodiazepines (A), benzodiazepine receptor agonists (A), daridorexant (A) and low-dose sedating antidepressants (B) can be used for the short-term treatment of insomnia (≤ 4 weeks). Longer-term treatment with these substances may be initiated in some cases, considering advantages and disadvantages (B). Orexin receptor antagonists can be used for periods of up to 3 months or longer in some cases (A). Prolonged-release melatonin can be used for up to 3 months in patients ≥ 55 years (B). Antihistaminergic drugs, antipsychotics, fast-release melatonin, ramelteon and phytotherapeutics are not recommended for insomnia treatment (A). Light therapy and exercise interventions may be useful as adjunct therapies to cognitive-behavioural therapy for insomnia (B).

Objective: Apply established principles of evidence-based medicine to the interpretation of the cost-effectiveness analysis related to the MINT Randomized Clinical Trials (RCTs). Design: Editorial Methods: Spine Intervention Society's guidelines for assessing studies on the treatment of pain were applied to a published cost-effectiveness analysis of radiofrequency denervation data from the MINT RCTs. Results: Application of evidence-based medicine principles reveals the MINT RCTs’ major deficiencies in patient selection, diagnostic paradigm, radiofrequency neurotomy technique, co-interventions, outcome measurement, power analysis study sample characteristics, data analysis, and loss to follow-up; which marginalizes the generalizability and conclusions of the cost-effectiveness analysis. Conclusions: The cost analysis performed in “Cost-Effectiveness of Radiofrequency Denervation for Patients With Chronic Low Back Pain: The MINT Randomized Clinical Trials” is based on the MINT RCTs results. The MINT RCTs significant metholodological design flaws, lead to issues in validty for the subsequent cost-effectiveness analysis. Application of the cost-effective analysis to patient care paradigms should be limited given the concerns with validity.

Objective: Apply established principles of evidence-based medicine to the interpretation of the cost-effectiveness analysis related to the MINT Randomized Clinical Trials (RCTs). Design: Editorial Methods: Spine Intervention Society's guidelines for assessing studies on the treatment of pain were applied to a published cost-effectiveness analysis of radiofrequency denervation data from the MINT RCTs. Results: Application of evidence-based medicine principles reveals the MINT RCTs’ major deficiencies in patient selection, diagnostic paradigm, radiofrequency neurotomy technique, co-interventions, outcome measurement, power analysis study sample characteristics, data analysis, and loss to follow-up; which marginalizes the generalizability and conclusions of the cost-effectiveness analysis. Conclusions: The cost analysis performed in “Cost-Effectiveness of Radiofrequency Denervation for Patients With Chronic Low Back Pain: The MINT Randomized Clinical Trials” is based on the MINT RCTs results. The MINT RCTs significant metholodological design flaws, lead to issues in validty for the subsequent cost-effectiveness analysis. Application of the cost-effective analysis to patient care paradigms should be limited given the concerns with validity.

INTRODUCTION: The insufficient quantity and quality of clinical epidemiological evidence in the field of rare diseases have posed methodological challenges to develop clinical practice guidelines (CPGs). Guideline development groups struggle to provide patients and their families with beneficial guidance, such as that for medical care and in complex circumstances. Motivated by the challenges, we focused on information on resources for supporting the daily and social life to improve the CPGs for users. We aimed to assess the methodological quality of CPGs for rare diseases in Japan and to evaluate information on resources to support the daily and social life in the CPGs. METHODS: We conducted a systematic search using PubMed, three electronic Japanese databases, and two hand-searched sources in Japan. The Appraisal of Guidelines for Research and Evaluation (AGREE) II instrument with six domains was used to assess the methodological quality of the CPGs. A content analysis of the CPG text was conducted using five keywords as information on non-medical resources, e.g., "Intractable Disease Consultation Support Center, " "Japan Intractable Disease Information Center, " and "Patient Association." RESULTS: A total of 55 CPGs met the inclusion criteria. Among four domains of AGREE II with low scores (Stakeholder Involvement, Rigor of Development, Applicability, and Editorial Independence), Rigor of Development had the lowest median score. As for information on non-medical resources, 41 CPGs included at least 1 of the 5 keywords, while 14 CPGs included none. CONCLUSIONS: At the Rigor of Development domain, methodological challenges may have resulted in an insufficient description of items regarding the translation evidence to recommendations. As the sufficiency of five keywords as information on non-medical resources could be improved, the information will be advocative as clues to provide pragmatic guidance, particularly for rare diseases with limited medical evidence.

Lay abstractExpert recommendations for toddlers who are likely to develop autism include caregivers being actively involved in the services children receive. However, many services available in the community may not follow these recommendations. Evidence suggests that an intervention named Project ImPACT for Toddlers demonstrates positive parent and child outcomes for families in the community. Project ImPACT for Toddlers was designed specifically for toddlers by a group of parents, clinicians, researchers, and funders. It teaches parents of young children strategies to support their child's development in daily routines. This study reports the perspectives of early intervention providers who learned to use Project ImPACT for Toddlers on whether the intervention was a good fit for their practice and easy to use. The study also examines how many agencies are using Project ImPACT for Toddlers and how many families have received the intervention in the community. The goal of the study is to inform the continued use of Project ImPACT for Toddlers in the community and support offering the intervention in other regions. Participants include 38 community providers who participated in a training study of Project ImPACT for Toddlers and completed a survey and semi-structured interview after approximately 3 months of using Project ImPACT for Toddlers with families. Participants perceived the training model as acceptable and appropriate, and identified the group-based model of training, comprehensive materials, and agency support as strengths of the approach. Survey findings complemented the results from the interviews. Data indicate an increasing number of agencies and families accessing Project ImPACT for Toddlers. Efforts to expand evidence-based intervention in early intervention should continue to build upon the model used for Project ImPACT for Toddlers.

BackgroundThere are a growing number of evidence-based interventions (EBIs) for autistic individuals, but few are successfully implemented with fidelity in under-resourced communities and with families from traditionally disenfranchised groups. Implementation science offers tools to increase EBI use in communities, but most implementation strategies are designed specific to a single EBI. It is not feasible to develop a new implementation strategy each time a new EBI is introduced in the community. Therefore, to test the effectiveness and generalizability of implementation strategies we are developing and testing a multifaceted implementation strategy with three EBIs concurrently. The goal of this protocol paper is to describe the randomized field trial of an implementation strategy for use across autism EBIs, diverse settings and participants, with the goal of increasing rapid uptake of effective practices to reach our most vulnerable children.MethodsWe developed a multifaceted implementation strategy called Using Novel Implementation Tools for Evidence-based intervention Delivery (UNITED) to facilitate the implementation and sustainment of three EBIs in under-resourced settings. We will compare fidelity to, and effectiveness of, each intervention [Mind the Gap (MTG), Remaking Recess (RR), Self-Determined Learning Model of Instruction (SDLMI)] with and without UNITED in a randomized field trial. Randomization will be stratified using a minimization allocation method. We will train community practitioners using remote delivery of modules specific to the intervention, and active coaching via Zoom for at least 6 sessions and up to 12 as dictated by each EBI. Our primary outcome is fidelity to each EBI, and our secondary outcome is at the child or family level (family empowerment for MTG, child peer social engagement for RR, and adolescent self-determination for SDLMI, respectively). We will measure progress through the implementation phases using the Stages of Implemen

This book addresses the over-prescribing of antidepressants in people with mostly mild and subthreshold depression. It outlines the steep increase in antidepressant prescription and critically examines the current scientific evidence on the efficacy and safety of antidepressants in depression. The book is not only concerned with the conflicting views as to whether antidepressants are useful or ineffective in various forms of depression, but also aims at detailing how flaws in the conduct and reporting of antidepressant trials have led to an overestimation of benefits and underestimation of harms. The transformation of the diagnostic concept of depression from a rare but serious disorder to an over-inclusive, highly prevalent but predominantly mild and self-limiting disorder is central to the books argument. It maintains that biological reductionism in psychiatry and pharmaceutical marketing reframed depression as a brain disorder, corroborating the overemphasis on drug treatment in both research and practice. Finally, the author goes on to explore how pharmaceutical companies have distorted the scientific literature on the efficacy and safety of antidepressants and how patient advocacy groups, leading academics, and medical organisations with pervasive financial ties to the industry helped to promote systematically biased benefit-harm evaluations, affecting public attitudes towards antidepressants as well as medical education, training, and practice.

The randomized controlled trial (RCT) is the gold standard for evaluating the causal effects of medications. Limitations of RCTs have led to increasing interest in using real-world evidence (RWE) to augment RCT evidence and inform decision making on medications. Although RWE can be either randomized or nonrandomized, nonrandomized RWE can capitalize on the recent proliferation of large healthcare databases and can often answer questions that cannot be answered in randomized studies due to resource constraints. However, the results of nonrandomized studies are much more likely to be impacted by confounding bias, and the existence of unmeasured confounders can never be completely ruled out. Furthermore, nonrandomized studies require more complex design considerations which can sometimes result in design-related biases. We discuss questions that can help investigators or evidence consumers evaluate the potential impact of confounding or other biases on their findings: Does the design emulate a hypothetical randomized trial design? Is the comparator or control condition appropriate? Does the primary analysis adjust for measured confounders? Do sensitivity analyses quantify the potential impact of residual confounding? Are methods open to inspection and (if possible) replication? Designing a high-quality nonrandomized study of medications remains challenging and requires broad expertise across a range of disciplines, including relevant clinical areas, epidemiology, and biostatistics. The questions posed in this paper provide a guiding framework for assessing the credibility of nonrandomized RWE and could be applied across many clinical questions.

Continued growth in the number of published clinical studies has necessitated changes to the way evidence-based resources such as clinical guidelines are developed and updated. The Australian and New Zealand Clinical Guidelines for Stroke Management (https://informme.org.au/guidelines/clinical-guidelines-for-stroke-management) are based on continual evidence surveillance and timely updates to recommendations as new research is published. In this article, we outline the main updates to recommendations since the guidelines moved into a living mode in 2018, and discuss key challenges and benefits of living guidelines.

Background: Complementary and alternative medicine (CAM) are non-conventional health care approaches used in parallel with or instead of conventional medicine. Little is known about Swedish patients’ patterns of complementary CAM use in the context of cancer. Patient-provider communication concerning CAM is crucial and research about communication in situations when patients decline recommended cancer treatment and consider CAM as an alternative is scarce. One commonly used CAM approach is an herbal medicinal product from mistletoe. An open-label trial on mistletoe extract for patients with advanced pancreatic cancer reported promising results on overall survival and quality of life. Due to limited treatment options for this group of patients, this approach needs to be investigated further. Aim: The overall aim of this thesis is to explore CAM use from patients’ and physicians’ perspectives and to design a placebo-controlled randomized clinical trial to assess mistletoe extract as a complement to standard treatment in patients with advanced pancreatic cancer. Methods: A cross-sectional design with quantitative and qualitative mixed methods was used in Study I including 755 patients with solid tumors. In Study II a qualitative design with face-to-face interviews with seven patients with cancer and ten physicians from cancer care was used. In Study III, a study protocol for a multicenter, parallel group, double-blind, randomized, placebo-controlled clinical trial (RCT) was developed. Mixed methods were used by two nested ancillary studies on sub-sets of participants with a translational and a qualitative design respectively. Patients with advanced pancreatic cancer (n=290) were included; mistletoe extract/placebo was added to treatment of choice for the duration of nine months. The trial is currently being conducted. Results: One of four patients with solid tumors used CAM parallel with conventional treatment. Main reasons motivations were the hope for improvement, Bakgrund: Komplementär och alternativmedicin (KAM) är ett samlingsnamn för ett stort antal metoder som används parallellt med eller i stället för konventionell medicin. Kunskapen om svenska patienters användning av KAM parallellt med gängse behandling i samband med en cancersjukdom är begränsad. Kommunikation om KAM mellan patienter och vårdgivare är viktig. Gällande situationer där patienter avböjer erbjuden cancerbehandling och överväger att använda KAM i stället för erbjuden cancerbehandling finns det mycket lite forskning. En ofta använd KAM metod vid cancer är växtbaserade läkemedel framställda av mistel. En studie på mistelextrakt för patienter med framskriden bukspottkörtelcancer visade lovande resultat på förlängd överlevnad och livskvalitet. Med tanke på de begränsade behandlingsmöjligheterna vid denna sjukdom bör metoden prövas närmare. Mål: Målet med denna avhandling är att undersöka KAM användning både från patienters och läkares perspektiv och att designa en placebokontrollerad randomiserad klinisk studie för att utvärdera mistelextrakt som ett tillägg till standardbehandling för patienter med framskriden bukspottkörtelcancer. Metoder: Studie I är en tvärsnittsstudie på 755 patienter med solida tumörer; studien har en blandad metoddesign bestående av både kvantitativa och kvalitativa metoder. Studie II är en kvalitativ intervjustudie med sju patienter med cancer och tio läkare som arbetar inom cancervården. I Studie III har ett studieprotokoll för en multi­center, dubbelblind, randomiserad placebokontrollerad klinisk studie med parallella grupper designats. En blandad studiedesign används med två inbäddade substudier på en mindre mängd deltagare från huvudstudien med en translationell design i den ena substudien och en kvalitativ design i den andra. Patienter med framskriden bukspottkörtelcancer (n=290) har inkluderats i studien och mistelextrakt respektive placebo har givits under nio månader som tillägg till standardbehandling. Resultat: En av fyra pa, Forskningsfinansiärer:Dagmar Ferbs Minnesfond, projekt MISTRALGyllenbergs stiftelse, projektnummer 2014, 2018Onkologiska klinikens gåvofond, Karolinska Universitetssjukhuset, projektnummer K0777-2011Regionalt Cancer Centrum, projekt 2013, 2015

Background: Complementary and alternative medicine (CAM) are non-conventional health care approaches used in parallel with or instead of conventional medicine. Little is known about Swedish patients’ patterns of complementary CAM use in the context of cancer. Patient-provider communication concerning CAM is crucial and research about communication in situations when patients decline recommended cancer treatment and consider CAM as an alternative is scarce. One commonly used CAM approach is an herbal medicinal product from mistletoe. An open-label trial on mistletoe extract for patients with advanced pancreatic cancer reported promising results on overall survival and quality of life. Due to limited treatment options for this group of patients, this approach needs to be investigated further. Aim: The overall aim of this thesis is to explore CAM use from patients’ and physicians’ perspectives and to design a placebo-controlled randomized clinical trial to assess mistletoe extract as a complement to standard treatment in patients with advanced pancreatic cancer. Methods: A cross-sectional design with quantitative and qualitative mixed methods was used in Study I including 755 patients with solid tumors. In Study II a qualitative design with face-to-face interviews with seven patients with cancer and ten physicians from cancer care was used. In Study III, a study protocol for a multicenter, parallel group, double-blind, randomized, placebo-controlled clinical trial (RCT) was developed. Mixed methods were used by two nested ancillary studies on sub-sets of participants with a translational and a qualitative design respectively. Patients with advanced pancreatic cancer (n=290) were included; mistletoe extract/placebo was added to treatment of choice for the duration of nine months. The trial is currently being conducted. Results: One of four patients with solid tumors used CAM parallel with conventional treatment. Main reasons motivations were the hope for improvement, Bakgrund: Komplementär och alternativmedicin (KAM) är ett samlingsnamn för ett stort antal metoder som används parallellt med eller i stället för konventionell medicin. Kunskapen om svenska patienters användning av KAM parallellt med gängse behandling i samband med en cancersjukdom är begränsad. Kommunikation om KAM mellan patienter och vårdgivare är viktig. Gällande situationer där patienter avböjer erbjuden cancerbehandling och överväger att använda KAM i stället för erbjuden cancerbehandling finns det mycket lite forskning. En ofta använd KAM metod vid cancer är växtbaserade läkemedel framställda av mistel. En studie på mistelextrakt för patienter med framskriden bukspottkörtelcancer visade lovande resultat på förlängd överlevnad och livskvalitet. Med tanke på de begränsade behandlingsmöjligheterna vid denna sjukdom bör metoden prövas närmare. Mål: Målet med denna avhandling är att undersöka KAM användning både från patienters och läkares perspektiv och att designa en placebokontrollerad randomiserad klinisk studie för att utvärdera mistelextrakt som ett tillägg till standardbehandling för patienter med framskriden bukspottkörtelcancer. Metoder: Studie I är en tvärsnittsstudie på 755 patienter med solida tumörer; studien har en blandad metoddesign bestående av både kvantitativa och kvalitativa metoder. Studie II är en kvalitativ intervjustudie med sju patienter med cancer och tio läkare som arbetar inom cancervården. I Studie III har ett studieprotokoll för en multi­center, dubbelblind, randomiserad placebokontrollerad klinisk studie med parallella grupper designats. En blandad studiedesign används med två inbäddade substudier på en mindre mängd deltagare från huvudstudien med en translationell design i den ena substudien och en kvalitativ design i den andra. Patienter med framskriden bukspottkörtelcancer (n=290) har inkluderats i studien och mistelextrakt respektive placebo har givits under nio månader som tillägg till standardbehandling. Resultat: En av fyra pa, Forskningsfinansiärer:Dagmar Ferbs Minnesfond, projekt MISTRALGyllenbergs stiftelse, projektnummer 2014, 2018Onkologiska klinikens gåvofond, Karolinska Universitetssjukhuset, projektnummer K0777-2011Regionalt Cancer Centrum, projekt 2013, 2015

Background: A large part of the population in Germany makes use of naturopathic, complementary and integrative medical treatments. There are now numerous scientific studies that provide evidence of efficacy for certain indications. At German medical faculties, selected procedures and their application are taught within the cross-sectoral unit called QB 12 and some elective courses, with a focus on specific aspects are offered. So far, however, there has been no structured curriculum that longitudinally anchors teaching across medical studies and enables all students to consider naturopathic and complementary medical options for patient care later on and to integrate them effectively into the diagnostic and treatment process.Objective: The aim of this position paper is to show the relevance of this topic for medical education, to clarify terminology and to present core competencies and possible implementation options for training.Method: The Integrative Medicine and Perspective Pluralism Committee of the German Association for Medical Education developed this position paper in a multi-stage consensual process, in cooperation with the Forum of University Work Groups on Naturopathic Treatment and Complementary Medicine.Results: First, different umbrella terms were discussed and an existing definition of integrative medicine and health was chosen for subsequent use. Building on this step, the status of education and its scientific foundation in Germany was considered in an international context. In the next step, a competency profile for medical training, consisting of seven areas of competency, was developed and described in detail with regard to naturopathic, complementary and integrative medicine. Implementation options were identified using possible starting points in the curriculum and using established examples of best practice.Conclusion: Despite different priorities at each faculty, it was possible to find an agreement on the development of competencies and anch, Hintergrund: Ein großer Anteil der Bevölkerung in Deutschland nimmt naturheilkundliche, komplementär- und integrativmedizinische Therapieverfahren in Anspruch. Mittlerweile existieren zahlreiche wissenschaftliche Studien, die einen Wirksamkeitsnachweis bei bestimmten Indikationen liefern. An deutschen Medizinischen Fakultäten werden ausgewählte Verfahren und deren Anwendung im Rahmen des Querschnittsbereichs 12 gelehrt, an einigen werden Wahlfächer mit eigenen Schwerpunktsetzungen angeboten. Bislang fehlt jedoch ein strukturiertes Curriculum, welches longitudinal die Lehre über das Medizinstudium hinweg verankert und alle Studierende befähigt, naturheilkundliche und komplementärmedizinische Optionen in der späteren Patientenversorgung zu berücksichtigen und wirksam in den Diagnostik- und Therapieprozess einzubinden.Zielsetzung: Ziel dieses Positionspapiers ist, die Relevanz des Themas für die medizinische Ausbildung darzustellen, begriffliche Klarheit zu schaffen sowie Kernkompetenzen und mögliche Implementierungsmöglichkeiten für die Ausbildung vorzustellen.Methode: Der Ausschuss Integrative Medizin und Perspektivenpluralismus der Gesellschaft für Medizinische Ausbildung erarbeitete in Zusammenarbeit mit dem Forum universitärer Arbeitsgruppen Naturheilverfahren und Komplementärmedizin das vorliegende Positionspapier in einem mehrstufigen konsensualen Prozess.Ergebnisse: Zunächst wurden unterschiedliche Oberbegriffe diskutiert und für die weitere Arbeit eine bestehende Definition für Integrative Medizin und Gesundheit ausgewählt. Darauf aufbauend wurde der Stand der Ausbildung und deren wissenschaftliche Fundierung in Deutschland im internationalen Kontext reflektiert. In einem weiteren Schritt wurde ein Kompetenzprofil für die medizinische Ausbildung, bestehend aus sieben Kompetenzbereichen, entwickelt und im Hinblick auf Naturheilverfahren, komplementäre und integrative Medizin detailliert dargestellt. Implementierungsmöglichkeiten wurden anhand möglicher Anknüpfu