Problemy sotsial'noi gigieny, zdravookhraneniia i istorii meditsinyV G Zilov, L V Kosmodemyansky
The article considers placement of methods of traditional and complementary medicine in the public health system of the Russian Federation, focusing on prevention and management of chronic non-communicable diseases. The analysis of the evidence base on key methods of traditional and complementary medicine (acupuncture, phytotherapy, homeopathy, manual therapy, osteopathy) was carried out, including differentiated estimate of level of evidence for forms of homeopathy based on the latest systematic review of meta-analyses. The legal framework of its application in Russia are explored. The corresponding collisions and barriers are identified. The following proposals concerning integrative health care model are formulated: differentiated register of methods, clinical guidelines, pilot integration into compulsory health insurance system and enhancement of research.
Zhonghua jie he he hu xi za zhi = Zhonghua jiehe he huxi zazhi = Chinese journal of tuberculosis and respiratory diseasesChinese Thoracic Society, Chinese Medical Association, Chinese Association of Chest Physicians
Interstitial lung disease (ILD) comprises a highly heterogeneous group of pulmonary disorders, whose diagnosis often requires the integration of clinical, radiologic, and pathologic evidence. Lung biopsy is a key method for obtaining a histopathologic diagnosis, but unified standards are lacking for determining indications, selecting biopsy techniques, managing patients perioperatively, and integrating pathologic and clinical information. To address these gaps, the Respiratory Physicians Branch of the Chinese Medical Doctor Association and the ILD Group of the Chinese Thoracic Society spearheaded this initiative, collaborating with national experts in respiratory medicine, radiology, pathology, thoracic surgery, and rheumatology to formulate this consensus. Developed in strict adherence to evidence-based medicine principles, this consensus is founded on systematic literature reviews and evidence grading, utilizing the Delphi method for anonymous voting. It culminates in 15 recommendations, each explicitly annotated with the level of evidence and strength of recommendation. This consensus systematically delineates the multidisciplinary discussion (MDD)-centered full-process management of lung biopsy. The main contents encompass: assessment of the necessity and feasibility of lung biopsy; indication stratification strategies based on HRCT patterns; applicability scenarios and selection pathways for the four major lung biopsy techniques; shared decision-making; perioperative comprehensive management; management strategies for acute exacerbation of ILD (AE-ILD); standardization of tissue processing and pathological reporting; the post-biopsy MDD process for integrated diagnosis; and biopsy decision-making in special clinical contexts, such as ILD complicated by lung cancer or connective tissue disease-associated ILD (CTD-ILD). This consensus aims to provide clinicians with clear, safe, and practical guidance on lung biopsy, promote standardized and precise decision-making, and improve patient outcomes.Summary of RecommendationsRecommendation 1: For patients with suspected ILD, a comprehensive multidisciplinary discussion (MDD) is mandatory prior to lung biopsy. This evaluation should establish the diagnostic certainty of the preliminary clinical assessment, evaluate the clinical utility of the biopsy, and facilitate shared decision-making (SDM) that incorporates patient preferences (Level of evidence: 3, Recommendation: strong).Recommendation 2: For ILD patients in whom the diagnosis remains uncertain following a comprehensive non-invasive evaluation, or when precise histopathologic subtyping is required, a lung biopsy is recommended to establish a definitive diagnosis and guide the therapeutic management (Level of evidence: 4, Recommendation: strong).Recommendation 3: For patients with an interstitial pattern, a lung biopsy is strongly discouraged if HRCT demonstrates a definite UIP pattern and secondary etiologies have been excluded. A conditional recommendation for a lung biopsy applies to patients with a probable UIP patterns in whom NSIP or fibrotic HP cannot be ruled out. A lung biopsy is strongly recommended to achieve a definitive diagnosis in patients with an indeterminate or non-UIP patterns and insufficient clinical evidence (Level of evidence: 4, Recommendation: conditional).Recommendation 4: For patients with an alveolar filling pattern, a lung biopsy is recommended to clarify the etiology once infection, alveolar hemorrhage, and pulmonary edema have been systematically excluded, and there is either a lack of response to empirical therapy or a clinical necessity to differentiate the lesion from malignancy (Level of evidence: 2, Recommendation: strong).Recommendation 5: For suspected rare ILDs, including PAP, iEP, LAM, and LIP, non-invasive or minimally invasive diagnostic modalities should be prioritized; a lung biopsy is conditionally recommended if these approaches are non-diagnositic. Conversely, a lung biopsy is strongly recommended for patients with clinically suspected AFOP or PLCH (Level of evidence: 2, Recommendation: conditional).Recommendation 6: Lung biopsy is not recommended for patients with acute respiratory failure, severe pulmonary functional impairment, recent cardiovascular events, hemodynamic instability, significant pulmonary hypertension, severe coagulopathy, or end-stage systemic debilitation (Level of evidence: 1, Recommendation: strong).Recommendation 7: Site selection for lung biopsy should target active lesions identified on HRCT (e.g., ground-glass opacities or fine reticulation). Specimens must include the interface between diseased and normal parenchyma to facilitate pattern assessment. High-risk areas, such as major vessels and severe bullae, must be strictly avoided. Multi-lobar sampling from at least two sites of varying severity is recommended to adequately capture disease heterogeneity (Level of evidence: 4, Recommendation: strong).Recommendation 8: A TBLB is recommended as the first-line diagnostic approach for suspected granulomatous diseases (e.g., sarcoidosis) and specific alveolar filling patterns. If a TBLB is non-diagnostic, escalation to TBLC or SLB is advised. A TBLB is not recommended for the evaluation of predominantly fibrotic ILDs (e.g., UIP or NSIP) (Level of evidence: 4, Recommendation: strong).Recommendation 9: TBLC is recommended as the preferred modality in expert centers, particularly for patients who are poor candidates for or are averse to SLB. The procedure should be standardized under general anesthesia with prophylactic balloon placement for hemorrhage control and integrated with imaging or navigational guidance to optimize diagnostic yield while minimizing procedural complications (Level of evidence: 2, Recommendation: strong).Recommendation 10: SLB is recommended for patients in whom TBLC yields a non-diagnostic result, provided their cardiopulmonary physiological reserve permits surgical intervention. Video-assisted thoracoscopic surgery (VATS) is the preferred approach, requiring sampling from at least two distinct lobes. Biopsies should prioritize the dependent segments of the upper lobes or the superior segments of the lower lobes; sampling from the lingula or the right middle lobe should only be considered if these sites harbor the most representative lesions and no superior alternatives exist (Level of evidence: 2, Recommendation: strong).Recommendation 11: PTNB is recommended for the diagnosis and differential diagnosis in ILD patients presenting with solitary nodules, masses, or focal consolidations, particularly to rule out malignancy. However, it is not recommended for the histopathological evaluation of diffuse fibrosing ILDs (Level of evidence: 2, Recommendation: strong).Recommendation 12: A shared decision-making model is recommended throughout the biopsy selection process. Clinicians should thoroughly counsel patients regarding the benefits, risks, and alternatives of the procedure, ultimately formulating a clinical plan that aligns medical evidence with patient values (Level of evidence: 4, Recommendation: strong).Recommendation 13: Histological or imaging patterns of usual interstitial pneumonia (UIP), active disease phase, and reduced diffusing capacity for carbon monoxide (DLCO) are the main risk factors for acute exacerbation of interstitial lung disease (AE-ILD). Routine prophylactic use of glucocorticoids or antifibrotic therapy is not recommended for all patients; instead, meticulous perioperative management is recommended to prevent acute exacerbations. Once AE occurs, the underlying cause should be promptly investigated, and high-dose glucocorticoids along with supportive therapy may be considered (Level of evidence: 2, Recommendation: strong).Recommendation 14: Histopathological reports must adhere to current international standardized nomenclature, prioritizing the description of the predominant histological patterns and their salient features, while specifically noting any findings indicative of a specific etiology. Diagnostic limitations secondary to suboptimal specimen quality must be explicitly stated. Pathologists are required to provide a systematic and standardized microscopic description of the tissue pathology, formulate a histopathological classification, and offer etiological insights whenever feasible (Level of evidence: 4, Recommendation: strong).Recommendation 15: Post-biopsy MDD is central to formulating an integrated diagnosis and should be conducted by the same cohort of clinicians, radiologists, and pathologists involved in the initial evaluation. A systematic correlation between the histopathology and the clinical andradiologic data is required; any discordances must be thoroughly analyzed to achieve a consensus integrated diagnosis and guide therapeutic planning. If an integrated diagnosis cannot be established, a subsequent MDD or referral to an expert center for a repeat biopsy is warranted (Level of evidence: 2, Recommendation: strong).
Radiographics : a review publication of the Radiological Society of North America, IncStephanie El Omeiri, Eva M Escavy-Zamora, Monica Miranda-Schaeubinger, Karen I Ramirez-Suarez, Shauna M Dougherty, Bernarda B Viteri, Summer L Kaplan, Hansel J…
Newborns and infants with certain perinatal exposures, congenital conditions, and genetic syndromes are at increased risk for clinically significant diseases and may benefit from early detection. In these children, imaging serves as a targeted screening tool to identify actionable abnormalities during a window in which intervention may reduce morbidity and long-term sequelae. The authors summarize evidence-based US screening strategies for high-risk newborns and infants encountered in clinical practice, including preterm infants, newborns with a breech presentation, children with congenital and syndromic conditions, and children with tumor predisposition syndromes. For each group, the authors discuss the rationale for screening, optimal timing, key technical considerations, and imaging findings that directly influence management. Across indications, effective screening follows common principles: risk-based selection rather than universal imaging, adherence to standardized protocols, and interpretation by radiologists familiar with population-specific disease patterns. When embedded within structured clinical pathways, targeted screening supports early diagnosis, guides multidisciplinary management, and helps prevent avoidable complications in vulnerable pediatric populations.
Evidence-based clinical decision support artificial intelligence (AI) is rapidly expanding, but its safe and effective use depends on rigorous validation, trustworthy evidence sources and careful integration into clinical workflows. Current available systems show strong potential to improve diagnostic accuracy, reduce clinician workload and possibly benefit patient care, but challenges remain before its real-world adoption. We must be responsible in its integration to ensure AI truly strengthens clinical judgment. This article is a viewpoint of AI tools for clinical decision support, addressing a rapidly evolving field and provides insights that are useful for clinicians and educators in clinical settings. When used within appropriate medical training, AI may help augment diagnostic accuracy and improve efficiency. Nevertheless, while AI offers promising features, it also presents ethical and reliability challenges, which may negatively affect the medical professional identity.
The journal of allergy and clinical immunology. In practiceMichael Nordness, Sharmilee M Nyenhuis, Nicholas L Rider, Stanley J Szefler, Sujani Kakumanu
The integration of research discoveries into routine clinical care is often slow and resource-intensive, particularly in allergy and immunology, where advances in biologics, immunotherapy, precision diagnostics, and guideline-driven management continue to evolve rapidly. Implementation science provides a structured approach to understand and address the gaps between research discovery and real-world patient care. In asthma, food allergy, atopic dermatitis, drug allergy, and primary immune disorders, variation in clinician knowledge, health system infrastructure, reimbursement models, patient demographics, and staffing patterns contribute to inconsistent uptake of evidence-based interventions. Implementation science offers tools to systematically evaluate these contextual factors and develop strategies that improve adoption, fidelity, sustainability, and equity in allergic and immunologic care. By offering theory-informed frameworks to design, adapt, and evaluate interventions across diverse clinical settings, implementation science advances the study of evidence-to-practice care gaps in allergy and immunology. When applied thoughtfully, these methods enhance implementation of specialty guidelines, practice parameters, and emerging therapies, while addressing multilevel determinants of care delivery. With the rapidly growing application of precision medicine and augmented intelligence to allergy and immunology practice, the study of how to best apply technological and research discovery to clinical practice will be needed to promote equitable uptake of evidence-based care.
Indian pediatricsJoseph L Mathew, Dipti Aggarwal, Sanjay Bafna, Kanchankumar Bhagyawant, Sonia Bhatt, Pallab Chatterjee, N S Chithambaram, Rashmi Ranjan Das, Hema Mittal, Sarik…
JUSTIFICATION: The lack of clarity in the management of pediatric empyema thoracis necessitates evidence-based guidance. OBJECTIVE: To develop an evidence-based guideline on high-priority issues in pediatric empyema management (laboratory investigations, antibiotic therapy, intrapleural fibrinolytic therapy, surgical intervention, and follow-up). PROCESS: The guideline was developed using contemporary methodology, viz. establishing a Steering Group; setting up an Evidence-Based Guideline Development Group (EBGDG); collating formal declarations of interest and managing conflicts; identifying and prioritizing questions; evidence synthesis; critical appraisal using GRADE methodology; translating evidence to recommendation statements; external peer review; and finalization of the guideline document. RECOMMENDATIONS: The dominant pathogen causing empyema in Indian children is Staphylococcus aureus, followed by Streptococcus pneumoniae. Therefore, the empirical antibiotics (pending culture reports) should preferably be the combination of Cloxacillin and Ceftriaxone (conditional recommendation, very low certainty of evidence). On the issue of intrapleural fibrinolytic therapy (IPFT) vs. no IPFT as the initial modality, pediatricians could use either option (in addition to oxygen, appropriate antibiotics, and effective pleural pus drainage) as the limited evidence did not show significant differences for critical outcomes (conditional recommendation, very low certainty of evidence). However, IPFT is recommended as the initial modality of therapy compared to Video-Assisted Thoracoscopic Surgery (VATS), on account of comparable efficacy, moderate savings, enhanced equity, stakeholder acceptability, and feasibility in diverse settings (conditional recommendation, very low certainty of evidence). The EBGDG does not recommend any particular intrapleural fibrinolytic agent over another due to a lack of comparative evidence (conditional recommendation, no evidence). The superiority of early initiation of IPFT (i.e. as the initial management, or at presentation), compared to late(r) instillation is not established in the absence of any evidence (conditional recommendation, no evidence). No recommendation can be made regarding the use of initial intrapleural fibrinolytic therapy (IPFT) (i.e., at or close to confirmation of empyema) versus IPFT after failure of intercostal chest drain (ICD) alone because of the absence of evidence (conditional recommendation, no evidence). Antibiotic therapy for ≤4 weeks is not suggested in preference to therapy for >4 weeks, despite the absence of direct evidence, owing to greater clinical experience with the latter, as well as its acceptability and feasibility (conditional recommendation, no evidence). Routine use of microbiologic molecular methods in preference to conventional culture techniques is not suggested, on account of greater specificity and lower cost of culture (conditional recommendation, very low certainty of evidence). Routine use of CT scan in preference to ultrasonography is not suggested for the management of children with empyema (conditional recommendation, very low evidence certainty). No clinical, radiological, microbiological, biomarker, or pleural fluid characteristics, either individually or in combination, were identified as predictors of failure of medical management (conditional recommendation, very low certainty of evidence). For each evidence-based recommendation, detailed justification, implementation considerations, and research priorities are outlined. CONCLUSION: This evidence-based guideline, developed using robust methodology, offers practical guidance for the management of empyema thoracis in children. This is expected to enhance the quality and standardization of care.
Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) are rare but life-threate-ning mucocutaneous reactions characterized by extensive epidermal detachment and systemic complications. Wound management is central to survival and long-term outcomes, yet standardiz-ed care pathways remain controversial and in-consistently implemented. This study aimed to systematically synthesize the best available evidence on wound management for patients with SJS/TEN to support clinical decision-making and optimize clinical outcomes. A comprehensive search of major international and Chinese databases and authoritative websites was conducted from January 2010 to May 2025 to collect relevant clinical decisions, guidelines, expert consensus, systematic reviews, and evidence summaries. Two reviewers independently screened and evaluated the literature, and then extracted and summarized evidence using the JBI grading system. A total of 14 high-quality publications met the inclusion criteria, yielding 28 pieces of best evidence across seven7 domains: wound assessment, conservative management, surgical approach, dressing selection, pain management, infection prevention and surveillance, and hospital setting. Among them, 11 recommendations were graded as strong and 17 as weak. This evidence-based synthesis provides practical guidance for wound management in SJS/TEN and supports the development of standardized care protocols to promote epithelial recovery, reduce complications, and improve quality of life.
Italian journal of pediatricsFederico Marchetti, Maurizio Bonati, Antonio Clavenna
Despite important regulatory progress, evidence supporting the use of medicines in children remains limited, and off-label prescribing continues to be common in pediatric practice. Regulatory initiatives such as the United States Pediatric Research Equity Act (PREA) and the European Pediatric Regulation were designed to increase the labelling information relevant to paediatric use, yet important gaps persist because studies are often delayed, incomplete, or absent for many conditions and formulations. This article addresses the common misconception that off-label prescribing is always inappropriate or unsupported and argues that this interpretation is not supported by the current evidence. In reality, many off-label treatments in pediatrics are supported by scientific evidence, clinical guidelines, and consolidated experience, even when formal regulatory approval is lacking. Examples involving pediatric oncology, child psychiatric disorders, and supportive care illustrate how effective therapies may remain off-label despite becoming standards of care. The Italian experience reflects these broader challenges. Studies have shown that off-label prescribing is structural rather than exceptional in pediatrics, while national initiatives such as Law 648/96 and pediatric formularies have sought to support evidence-based prescribing beyond regulatory boundaries. It is necessary to overcome the simplistic distinction between prescriptions that comply with the indications and appropriate prescriptions. A more rational framework should distinguish unsupported off-label use from evidence-based off-label prescribing. Reducing the pediatric evidence gap therefore requires not only more pediatric research, but also recognition of rational off-label prescribing as an essential component of pediatric clinical practice.
Clinical oral investigationsDaniele Manfredini, Gary D Klasser, Alessandro Bracci, Charles S Greene, Louis G Mercuri, Sanjvan Kandasamy
OBJECTIVE: The goal of any disease classification system, based on the core principles of translational and evidence-based medicine, is to develop management plans that provide appropriate high-quality patient care based on accurate diagnoses, according to the core principles of translational medicine. MATERIALS AND METHODS: Within these premises, the current classification schemes that are available in the field of temporomandibular disorders (TMDs) practice are hardly clinically useful and patient oriented. The publication of the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) is a milestone achievement that serves as a foundation of the discipline, but it clearly lacks the needed impact on the everyday practice and treatment planning. From being the potential solution to the necessity of standardizing TMD classification, the DC/TMD became an enigma in search of a solution: how to progress and move on to embed current evidence-based knowledge into a diagnostic and classification schemes that can be adopted both for academic and clinical purposes? RESULTS: This manuscript provides an overview of the reasons why the time has come to rethink, reconceptualize and reconfigure the currently accepted concepts and develop concepts based on the current body of evidence that provide improved clinical usefulness and medical semantics. CONCLUSIONS: There will be a long and difficult task ahead, but it is time to get to work and try solving the DC/TMD conundrum for the advancement of our field and enhanced care for our patients. CLINICAL RELEVANCE: The field of orofacial pain and temporomandibular disorders is constantly evolving, and the need for patient-oriented, clinical-friendly classification systems that facilitate treatment plan is emerging.
Zeitschrift fur GastroenterologieAlexander Barton, Jörn M Schattenberg
Metabolic dysfunction-associated steatotic liver disease (MASLD) is a progressive liver disorder characterized by inflammation, fibrosis, and metabolic dysfunction. In recent years, therapeutic options have expanded significantly. The thyroid hormone receptor-β agonist resmetirom became the first drug approved in Germany in 2025 for non-cirrhotic MASH with moderate to advanced fibrosis. Furthermore, incretin mimetics, originally developed for diabetes and obesity, are being investigated. In a phase 3 study, semaglutide demonstrated significant improvements in hepatic inflammation and fibrosis. Beyond GLP-1 analogs, which act indirectly through metabolic pathways, several liver fibrosis-specific therapies are emerging, including FGF-21 analogs and dual incretin receptor agonists (e.g. survodutide) that directly affect hepatocytes via glucagon receptor signaling. Combination therapies are increasingly being explored to harness synergistic effects and enable individualized treatment. Ongoing phase 3 studies assess long-term efficacy and safety. In parallel, biomarkers are being refined for patient selection and treatment monitoring. The German SLD Registry will collect patient data and clinical outcomes following the implementation of new therapies. This review summarizes recent advances and future perspectives in the pharmacological treatment of MASH. The combination of metabolic and liver-targeted therapies offers substantial promise for personalized medicine.
Zeitschrift fur GastroenterologieElke Roeb, Andreas Geier
Metabolic dysfunction-associated steatotic liver disease (MASLD) has become a major global health challenge, largely driven by the increasing prevalence of obesity and type 2 diabetes mellitus. The disease spectrum ranges from isolated steatosis to metabolic dysfunction-associated steatohepatitis (MASH) with progressive fibrosis. Advanced fibrosis substantially increases the risk of cirrhosis, hepatocellular carcinoma, and cardiovascular complications, thereby contributing significantly to morbidity and mortality.Although lifestyle modification remains the cornerstone of therapy, pharmacological treatment is gaining importance in patients with progressive disease or high-risk profiles. Advances in the understanding of MASLD pathophysiology have enabled the development of targeted therapies addressing hepatic lipid accumulation, insulin resistance, inflammation, and fibrogenesis. Promising clinical data have been reported for resmetirom, semaglutide, tirzepatide, survodutide, lanifibranor, and fibroblast growth factor-21 analogues including efruxifermin, pegozafermin, and efimosfermin.This review summarises current and emerging diagnostic and therapeutic strategies and provides practical guidance for clinical management. In addition, a structured treatment algorithm for non-cirrhotic MASLD (F0-F3), restricted to therapies currently available in Europe and stratified according to diabetes status and fibrosis stage, is proposed as an evidence-based tool for routine clinical practice.
Zeitschrift fur GastroenterologieChristopher Tuffs, Anca Laura Amati, Daniar Amin, Sonali Raj, Thilo Sprenger, Andreas Hecker, Martin Schneider, Martin Reichert, Moritz J Strowitzki
Metabolic dysfunction-associated steatotic liver disease (MASLD) is the most common chronic liver disease and a major hepatic manifestation of metabolic syndrome. It is closely linked to obesity and type 2 diabetes mellitus. While many patients display a steatotic liver, some progress to steatohepatitis, fibrosis, and cirrhosis, increasing the risk of hepatocellular carcinoma (HCC). Current management targets metabolic risk factors. Metabolic and bariatric surgery (MBS) has therefore emerged as both an obesity treatment and a therapeutic option for MASLD. This narrative review summarizes evidence on clinical outcomes, efficacy, and mechanisms. Histology-based studies show MASLD resolution and relevant fibrosis regression after MBS, with durable benefits. Comparative studies indicate superiority over lifestyle intervention and conservative treatment, while direct comparisons with modern drugs (e.g. GLP-1 agonists) remain limited. Mechanistic studies suggest that MASLD remission by MBS is driven through a combination of sustained weight loss and surgery-specific effects on hepatic lipid metabolism, mitochondrial function, glucose metabolism, incretin and bile acid signalling, adipose tissue biology, and the gut-liver axis. Emerging evidence suggests fewer liver-related events and lower HCC incidence, with potential benefits in selected high-risk patients. In conclusion, MBS is not merely a weight loss intervention, but a disease-modifying, multi-system metabolic therapy with direct hepatic effects.
With the introduction of steatotic liver disease (SLD) as an umbrella term and metabolic dysfunction-associated steatotic liver disease (MASLD) as one of its major subcategories, a new diagnostic category was proposed to better reflect the coexistence of metabolic dysfunction and alcohol consumption: MetALD. MetALD identifies individuals with hepatic steatosis and cardiometabolic risk factors whose alcohol intake exceeds MASLD thresholds but remains below the levels typical of alcohol-related liver disease. The prevalence of MetALD in the general population is approximately 4%. Evidence suggests that MetALD is associated with more severe liver-related outcomes and higher all-cause mortality compared to MASLD, although findings are not entirely consistent. Despite these risks, MetALD remains underdiagnosed because alcohol consumption is often self-reported and underestimated due to recall bias, social desirability bias, or stigma. Consequently, managing MetALD requires a multidisciplinary approach addressing both cardiometabolic comorbidities and alcohol-related behavioral factors. MetALD should be viewed not only as a medical condition but also as a disorder with significant behavioral and social dimensions that influence diagnosis, treatment adherence, and long-term outcomes. This review discusses the clinical implications and therapeutic considerations specific to this newly introduced terminology.
History and philosophy of the life sciencesFiorela Alassia
This paper examines the structural tension between universalism and individuality in modern medicine. By universalism, I refer to the epistemological commitment to producing general, abstract knowledge about health and disease through classifications, generalizable models of physiological process, statistical evidence, and standardized therapeutic protocols. By individuality, I refer to the biological uniqueness of each patient as a concrete organism possessing a singular configuration of traits and circumstances. The central argument is that modern medicine has historically depended on universalist forms of knowledge, while clinical practice must always apply such knowledge to biologically unique individuals. This generates a persistent tension between the abstract-conceptual level of biomedical research and the concrete level of the individual patient at the clinical encounter. After clarifying the notion of biological individuality in medicine and reconstructing the historical emergence of universalism as a foundational principle of modern medicine, the paper analyzes three contemporary domains in which this tension becomes especially salient: external validity in evidence-based medicine, the constitution of reference classes, and the epistemic challenges of clinical practice. Recognizing this tension is necessary for a more precise understanding of both the possibilities and the limits of medicine in its engagement with biologically unique patients.
Tidsskrift for den Norske laegeforening : tidsskrift for praktisk medicin, ny raekkeKnut Steen, Torbjørn Hiis Bergh, Regina Küfner Lein, Christina Elisabeth Brudvik
BACKGROUND AND AIM: Face masks are routinely worn by healthcare personnel as an infection prevention measure during surgical procedures in hospitals. Their use is more variable in general practice and emergency clinics. We assessed the scientific evidence underpinning the use of face masks during invasive surgical procedures to prevent postoperative infections. EVIDENCE BASE: We performed a systematic literature search using predefined criteria in the Medline, Embase and Cochrane Library databases. The intervention was the use or non-use of face masks during invasive surgical procedures. The outcome was clinical infection. RESULTS: The literature search yielded 675 records and identified eight relevant studies. An additional study was identified from the reference lists. Eight of the nine studies, including the two with the highest methodological quality, found no significant difference in postoperative infection rates according to whether face masks were used or not. In the two studies with the highest quality, the differences between the two groups in terms of the proportion with an infection were 1.2% and 3.5%, respectively. One study found a significantly higher infection rate when face masks were used. INTERPRETATION: There is insufficient high-quality scientific evidence to support the use of face masks during invasive surgical procedures to reduce the incidence of postoperative infections.
Journal of primary care & community healthChristopher R Stephenson, Christopher A Aakre, Ivana T Croghan, Ryan T Hurt, Colin P West
Large language models (LLMs) are increasingly used in primary care for documentation, patient communication, and clinical decision support. However, many clinicians are adopting these tools for patient care without structured training or a clear understanding of their limitations. LLM output may appear authoritative but can be inaccurate, biased, and unsupported by evidence. This creates a growing gap in artificial intelligence LLM literacy. Clinicians need practical strategies to evaluate when LLM-generated information can be trusted and how to apply it to patient care. This article proposes an evidence-based framework for critically appraising the output of LLMs at the point of care. Building on principles from evidence-based medicine (EBM), we describe three levels of appraisal: 1) internal validation, 2) external verification, and 3) contextual application. Internal validation assesses whether the LLM output is stable, logically sound, and appropriately addresses uncertainty. External verification determines whether the output is accurate and supported by external evidence, including guidelines, peer-reviewed literature, or trusted clinical references. Contextual application evaluates whether the output is appropriate for the individual patient, taking into account comorbidities, social context, health literacy, patient preferences, and shared decision-making. The rigor of appraisal should be scaled to the clinical risk. Lower-risk uses, such as drafting patient education materials or simple communications, may require only editorial review. Higher-risk uses, such as diagnostic or management reasoning, require more rigorous appraisal before recommendations can be applied. LLMs may reduce cognitive load and improve efficiency, but they do not replace clinical judgment. Safe AI use in primary care depends not only on the sophistication of the LLM but also on the clinician's ability to critically evaluate, verify, and contextualize its output.
Bundesgesundheitsblatt, Gesundheitsforschung, GesundheitsschutzMartin Scherer, Thomas Zimmermann, Eva Hummers
International comparisons show that healthcare systems with strong, coordinated primary care often achieve better health outcomes while using resources more efficiently. Against this background, this narrative review, based on the available literature and data from the Organisation for Economic Co-operation and Development (OECD), provides an overview of healthcare structures, utilization, and outcomes in Germany compared with 11 other European countries and interprets the findings in the context of healthcare systems coordinated by primary care.The results show that Germany is characterized by high utilization of healthcare services and high healthcare expenditure, while at the same time performing comparatively poorly on key health indicators, particularly avoidable mortality. Stronger coordination through primary care could help improve these outcomes.At the same time, the findings highlight that the success of primary care-coordinated healthcare systems depends critically on their structural framework. In addition to sufficient primary care capacity, interprofessional teams, robust digital infrastructure, and binding mechanisms for coordination and feedback are essential prerequisites. Strengthening primary care alone, however, is not sufficient: its effectiveness requires far-reaching structural reforms and a stronger orientation of the healthcare system toward preventive measures.
Bundesgesundheitsblatt, Gesundheitsforschung, GesundheitsschutzMartin Lambert, Anja Zimmermann, Jürgen Gallinat
Severe mental illness (SMI) is associated with chronic courses, significant functional impairments, and increased mortality. At the same time, care for this population is characterized by fragmentation, lack of continuity, and insufficient coordination. Against this background, patient navigation has gained importance as an approach to improving the quality and efficiency of care. The aim of this narrative review is to present key evidence-based models of care for individuals with SMI, to analyze structural challenges in service provision, and to derive principles for effective patient navigation.The evidence shows that community-based, multidisciplinary, and continuous care approaches-such as assertive community treatment, crisis intervention, and early intervention programs-can improve clinical and functional outcomes, reduce hospitalizations, and enhance continuity of care. At the same time, it becomes clear that the isolated implementation of individual intervention models is insufficient to sustainably address structural deficits.Integrated and stepped care models enable the systematic linkage of evidence-based interventions along a continuous care pathway. Current findings indicate that such approaches can improve quality of care while being implementable without additional costs and may even generate cost savings. Patient navigation thus represents a key strategy to strengthen continuity of care, reduce fragmentation, and sustainably improve patient outcomes as well as resource efficiency.
Operative Orthopadie und TraumatologieMartin C Jordan, Justus Bremer, Abdul Al Refai, Felix Wolff, Georgi I Wassilew, Janosch Schoon, Stefan Zwingenberger, Philipp Heilig
OBJECTIVE: Safe and complete removal of osteosynthesis materials while preserving the surrounding soft tissues. INDICATIONS: Indications include implant-related pain, soft-tissue irritation, infection, implant failure, pseudarthrosis, and risk to adjacent tendons, nerves, or vessels as well as implants in children. CONTRAINDICATIONS: Disproportionate procedural risk in patients with poor bone quality, extensive scarring, or high surgical morbidity. SURGICAL TECHNIQUE: Thorough preoperative planning, precise identification of the implant type and manufacturer, and the availability of the manufacturer's original extraction tools as well as alternative extraction instruments-such as special extractors, carbide drills, and hollow reamers-are essential. In this article, stepwise removal techniques are detailed for screws, plates, intramedullary nails, and spinal or pelvic implants, including strategies for managing stripped, cold-welded, or fractured implants. POSTOPERATIVE MANAGEMENT: Early functional rehabilitation is encouraged. Following removal of load-bearing implants, temporary activity restrictions and postoperative X‑rays to detect iatrogenic fractures are recommended. CLINICAL RELEVANCE: Implant removal is a frequent yet technically demanding procedure. Careful preparation, appropriate instrumentation, and meticulous technique reduce complications and enhance patient safety.
Zhongguo xiu fu chong jian wai ke za zhi = Zhongguo xiufu chongjian waike zazhi = Chinese journal of reparative and reconstructive surgeryYi Ye, Bing Lu, Chengwei Xiao, Fei Lan, Xiaoxue Li, Kun Zhang
In November 2025, the American Academy of Orthopaedic Surgeons (AAOS) released the updated Clinical Practice Guideline for the Management of Acute Compartment Syndrome (ACS). This guideline addresses key issues including early diagnostic strategies, surgical decision-making, and perioperative management, presenting 8 recommendations and 7 consensus statements. A systematic interpretation highlights the core recommendations regarding the diagnostic value of biomarkers, the important role of compartment pressure monitoring, surgical decision-making, and wound management. A major update is the upgrade of the recommendation for early fixation of long bone fractures in ACS patients with associated fractures from expert consensus to a limited recommendation. Compared with the Chinese Guideline for Early Diagnosis and Treatment of Acute Compartment Syndrome (2020 edition), there were three key similarities and differences. Diagnostic strategy: both guidelines value compartment pressure monitoring, but the Chinese guideline emphasizes its diagnostic role, whereas the AAOS guideline focuses on its utility in dynamic monitoring to help rule out ACS. Biomarkers: Chinese guidelines suggests that serum lactate, serum cardiac troponin, and myoglobinuria may serve as indicators of traumatic ACS; the AAOS guideline only recognizes myoglobinuria, serum troponin, and, in specific contexts, femoral venous lactate as having adjunctive value, and explicitly states that serum biomarkers should not be used as the basis for fasciotomy decision-making in late or missed ACS. Treatment: both guidelines emphasize that once the diagnosis is confirmed, early fasciotomy should be performed. The AAOS guideline provides a reference for Chinese clinicians to improve early recognition and standardized management of ACS.
Orthopadie (Heidelberg, Germany)Fabian Westhauser, Stefano Pagano, Marie T Heller, Max Thieme, Tobias Renkawitz
BACKGROUND: Robotically assisted knee arthroplasty (r-CAS) enables highly precise implant placement. However, current evidence shows no consistent advantage in clinical outcomes or implant survivorship. Scientific evaluation is challenged by both the technical heterogeneity of robotic systems and the rapid evolution of software, including AI-driven optimization algorithms. These differences affect workflow, accuracy, and outcomes, limiting study comparability. PROSPECTS: Future value will likely lie less in further improving precision and more in enabling personalized treatment through integration of kinematic analysis and intelligent decision-support models. This will require not only advanced hardware, software, and algorithms, but also new dynamic real-world evidence approaches to assess patient benefit.The present article provides an overview of the current state of evidence-based research for r-CAS and discusses approaches for bringing rapid technological advancements into balance with valid, patient-centered research in the future.
NeurosurgeryGeorge W Koutsouras, Silky Chotai, Brandon Laing, David F Bauer, Thomas Larrew, Tiffany R Hodges, Jeffrey J Olson, Anand Veeravagu, Joseph Osorio
INTRODUCTION: The Congress of Neurological Surgeons (CNS) has established one of the most comprehensive and visible evidence-based guideline programs in organized neurosurgery. As clinical practice guidelines continue to evolve in response to increasingly rigorous methodological standards, periodic reassessment of development processes is essential to preserve transparency, scientific rigor, and clinical relevance. METHODS: This manuscript presents a comprehensive cross-specialty comparison of neurosurgical guideline methodology, systematically evaluating the CNS standard operating procedures against those of leading medical and surgical organizations, including the American Academy of Pediatrics, American Academy of Neurology, North American Spine Society, American College of Radiology, and National Academy of Medicine. Key domains reviewed included conflict of interest management, topic selection, literature search strategy, systematic review methodology, evidence grading, peer review, and guideline update protocols. RESULTS: Comparative analysis identified several best practices that have now been incorporated into the CNS methodology, including formal inclusion of patient representatives on guideline task forces, expanded participation of CNS Guidelines Fellows in double-blind screening and evidence review, implementation of a secondary medical librarian literature update prior to publication, formal annual surveillance of published guidelines, and creation of an expedited rapid-response update pathway for high-impact emerging evidence. Additional refinements include stricter Patient, Intervention/Exposure, Comparison, Outcome (where applicable, Timing and Setting)-based question development, clarified evidence thresholds distinguishing guidelines from practice parameters, and modernization of systematic review software workflows. CONCLUSION: Collectively, these enhancements strengthen the credibility, timeliness, and patient-centeredness of CNS guidelines while reinforcing methodological consistency across neurosurgical subspecialties. By documenting these refinements, the CNS provides a transparent reference model for evidence-based guideline development and reaffirms its leadership role in establishing the gold standard for neurosurgical clinical practice recommendations.
Journal of evidence-based medicineZhuotong Wu, Yiling Zhou, Lin Li, Yinuo Liu, Yuqi Liao, Keer Chen, Huichang Jia, Meng Wu, Jumin Deng, Binchi Liao, Zhangshu Xie, Sheyu Li, Ying Wu
OBJECTIVE: To assess the population representativeness of randomized controlled trials (RCTs) and real-world evidence (RWE) studies in end-stage kidney disease (ESKD) relative to the United States Renal Data System (USRDS) target population. The primary aim was to evaluate the generalizability of US-based evidence, and the secondary aim to examine the transportability of non-US evidence to the US dialysis population. METHODS: We searched PubMed for RCTs and RWE studies in ESKD dialysis populations (2007-2024). Random-effects models were used to pool effect modifiers and mortality rates separately for US-based and non-US RCTs and RWE studies. The primary outcome was a composite representativeness measure, defined as no meaningful deviation across all effect modifiers and mortality rate relative to USRDS benchmarks. Secondary outcomes were single-component representativeness measures for age, diabetes prevalence, and mortality rate. Meaningful deviation was defined as absolute standardized mean difference (SMD) >0.25. Subgroup and sensitivity analyses were conducted. RESULTS: We included 194 RCTs (n = 71,119) and 173 RWE studies (n = 50,931,214). For the primary aim, neither US-based RCT samples nor US-based RWE samples were representative. RCT participants were younger (SMD = -0.27) and had lower mortality rates (SMD = -1.52) than the USRDS population, whereas RWE samples showed no meaningful deviations in age, diabetes prevalence, or mortality rate (SMDs = 0.00, -0.11, and 0.08). Meaningful deviations in other effect modifiers remained in both study types. Non-US samples also showed limited representativeness. CONCLUSIONS: RCTs and RWE studies demonstrate limited representativeness, underscoring the need to validate and adapt evidence before clinical application.
Schmerz (Berlin, Germany)Axel Gassen, Julia Wölfle-Roos
Back pain is among the leading causes of disability and work absenteeism worldwide. Approximately 85-90% of cases are classified as non-specific and mostly show an innocuous trajectory. Decisive for the guideline-conform management are the structured differentiation of specific causes, early identification of chronicity risk factors and an activating biopsychosocial treatment approach. Imaging should only be performed when clinically indicated. Exercise therapy represents the central conservative treatment modality. Pharmacotherapies are mainly used to support active rehabilitation strategies. Interdisciplinary multimodal programs improve long-term function, participation and quality of life, particularly in chronic pain conditions. Interventional procedures can be meaningful in selected patients with clearly defined indications.
Zeitschrift fur Gerontologie und GeriatrieWalter Hewer, Daniel Kopf
Causal and general therapeutic measures, as well as non-pharmacological interventions are key elements in the prevention and treatment of non-substance-induced delirium. However, if certain target symptoms persist, such as delusions, hallucinations or marked agitation, there is an indication for psychopharmacotherapy, usually with antipsychotics. This narrative review provides an overview of the current state of knowledge on this topic, with particular reference to the recently published Association of the Scientific Medical Societies in Germany (AWMF) guideline, "Delirium in Older Adults". The guidline focuses on how to achieve the best possible balance between benefits and risks when using high-risk medication in vulnerable patients.
Current pain and headache reportsJessica Nicolas, Matteo Luigi Giuseppe Leoni, Y Van Tran, Pham Van Phong, Giacomo Farì, Piercarlo Sarzi Puttini, Alan D Kaye, Giustino Varrassi
PURPOSE OF REVIEW: Paracetamol (acetaminophen) is among the most widely used medications in the history of humanity for treatment of pain conditions. For more than half a century, it has occupied a unique position as the archetypal first-line analgesic and antipyretic, recommended across age groups, clinical settings, and healthcare systems. Its remarkable success has been based on three fundamental assumptions: it is effective for common painful conditions, substantially safer than alternative analgesics, and suitable for broad population use with minimal restrictions. Over the last two decades, however, these assumptions have been increasingly challenged by accumulating evidence from randomized trials, systematic reviews, pharmaco-epidemiological studies, and regulatory analyses. RECENT FINDINGS: The history of paracetamol represents an instructive example of evidence reversal in modern medicine and pain management. Originally introduced as a safer successor to phenacetin, paracetamol benefited from a favorable safety reputation that often exceeded the available scientific evidence. Subsequent investigations have revealed a more complex reality. Hepatotoxicity has emerged as a leading cause of acute liver failure worldwide, efficacy in chronic musculoskeletal disorders has proved substantially lower than previously assumed, and concerns regarding long-term safety and use during pregnancy have generated ongoing scientific debate. Simultaneously, clinical practice and prescribing habits remained largely unchanged despite evolving evidence and repeated modifications of international guidelines. By examining major assumptions, scientific misconceptions, regulatory decisions, and evidence reversals, this review explores how one of medicine's most familiar drugs in pain medicine became a paradigm of the challenges inherent in translating evolving scientific evidence into clinical practice. Beyond paracetamol itself, this story provides broader lessons regarding therapeutic inertia, medical dogma, risk perception, and the dynamic nature of evidence-based medicine.
Saudi medical journalMaha M Aleid, Manar A Alharbi, Amal N Almadouj, Ahmad I Alrawaji, Lamia A Alhaqbani, Fars K Alanazi
OBJECTIVES: To present a reproducible national model for translating research findings into evidence-based clinical practice guidelines. METHODS: The Saudi National Institute of Health launched the initiative titled "Transforming the Outcomes of Published Health Research into Medical Guidelines that Enhance Medical Practices to Improve the Quality of Human Health" on February 3, 2025. The initiative aimed to identify and assess research outcomes published between January 1, 2020, and December 31, 2024 across 6 predefined thematic tracks relevant to the Saudi population. Eligible publications were collected within one month after the submission portal opened. Following closure of portal, all submissions were evaluated using the 14th Knowledge Translation Toolkits, and a weighted score was calculated using a Knowledge Translation Nexus Scoring System to generate final results. RESULTS: A total of 390 publications were submitted through the online portal by 206 researchers from 128 institutions. The infectious diseases track accounted for the highest number of submissions (108; 28%), followed by oncology (70; 18%), and both rare and inherited diseases (47; 12%) and diabetes tracks (35; 9%). Ultimately, 40 publications were selected for recommendation. The liver track showed the highest median final score across all tracks and was significantly different from the cardiovascular, diabetes, and rare and inherited disease. CONCLUSION: This initiative established a structural national framework that strengthens local research in guideline development and promotes evidence-informed health decisions. This approach can be adopted and adapted across various settings.
Zeitschrift fur Gerontologie und GeriatrieMarlena Schnieder
Alzheimer's disease, the leading cause of dementia, is defined by extracellular amyloid‑β (Aβ) plaques, intracellular tau aggregates and neurodegeneration. Lecanemab and donanemab, are the first disease-modifying antibodies available for early Alzheimer's disease. Both reduce Aβ plaques and slow cognitive decline. Lecanemab targets soluble protofibrils and donanemab targets fibrillar Aβ. The primary side effect is amyloid-related imaging abnormalities (ARIA), which can occur as edema (ARIA-E) or hemorrhages (ARIA-H). The risk is higher in APOE4 homozygotes, anticoagulation or cerebrovascular diseases. Therefore, during treatment a regular monitoring with magnetic resonance imaging (MRI) is mandatory.
Zhonghua yi xue za zhiNational Pharmaceutical Affairs Management Medical Quality Control Center, Clinical Pharmacy Branch of Chinese Medical Association
Intravenous to oral switch (IVOS) is the core strategy to optimize the route of administration and reduce unnecessary intravenous infusion. Although the drug administration switching mode has been gradually implemented in China, there is still a lack of unified and implementable standardized guidance in key links such as patient evaluation and switching opportunity. Therefore, the National Pharmaceutical Affairs Management Medical Quality Control Center and the Clinical Pharmacy Branch of the Chinese Medical Association organized experts and scholars in related fields in China to compile this guidelines based on the latest evidence-based medicine evidence at home and abroad. This guidelines focus on the core contents of IVOS screening for adult inpatients, switching timing, evaluation criteria, operational procedures, etc. Finally 18 questions and 24 recommendations were formed, forming the clinical application guidelines for IVOS medication in adult inpatients, aiming at providing scientific and practical decision-making basis for clinical rational intravenous drug use, improving medical quality, ensuring the safety of patients' medication, and optimizing the allocation of medical resources.
Journal of evidence-based integrative medicineLeonard Ho, Vanessa Cheuk Yan Li, Claire Chenwen Zhong, Haiyong Chen, Sheung Wai Law, Edwin Chau Leung Yu, Fiona Pui Yan Lam, Yi Chung Cheung, Irene Xinyin Wu,…
Study BackgroundEstablishing an evidence-informed expert consensus on the use of acupuncture for managing chronic musculoskeletal pain at the primary care level in Hong Kong, using the GRADE Evidence to Decision (EtD) framework. Two-rounds of Delphi study were conducted guided by the GRADE-ADOLOPMENT approach and informed by systematic review.MethodsSixteen local experts, including eight traditional Chinese medicine practitioners and eight biomedically trained doctors, were purposively sampled based on their clinical experience in pain management. A structured questionnaire was developed based on seven chronic musculoskeletal conditions and aligned with the six GRADE EtD criteria. Experts rated the appropriateness of acupuncture for each condition using a 4-point Likert scale. Consensus was defined as ≥75.0% agreement. Participants reviewed diagnostic criteria and selected core outcomes for evaluating treatment effectiveness.ResultsPositive consensus supported acupuncture for adhesive capsulitis, knee osteoarthritis, lumbar spinal stenosis with neurogenic claudication, and non-specific low back pain. Full agreement was reached on diagnostic criteria for all seven conditions. Pain relief, functional improvement, and health-related quality of life were identified as core outcomes. No consensus was reached for hip osteoarthritis, cervical radiculopathy, or lumbar radiculopathy. Experts highlighted the need for individualised treatment plans and further research on implementation and patient preferences.ConclusionThis study presents the first expert-endorsed list of acupuncture recommendations for chronic musculoskeletal pain in Hong Kong. The findings support interprofessional collaboration and provide a foundation for developing referral pathways and clinical guidelines. However, the study is limited by reliance on expert opinion and indirect evidence, a potentially non-representative panel, and the absence of physiotherapist and patient perspectives. Future research should focus on implementation strategies and incorporate input from various stakeholder groups to strengthen the clinical integration of acupuncture.
The Journal of dermatological treatmentMohammed Ibrahim Fatani, Yousef Binamer, Dana Alessa, Hajer Y Almudaiheem, Mohammed Abdulaziz Alajlan, Issam Hamadah, Bedor A Al-Omari, Fahad Alzuriqan, Haifa …
BACKGROUND: Psoriasis is a chronic, immune-mediated inflammatory skin disease that affects approximately 5.3% of the population in the Kingdom of Saudi Arabia (KSA). Thus, we aim to develop updated evidence-based clinical practice guidelines for the management of adults and pediatric patients with moderate-to-severe plaque psoriasis in the KSA. METHODS: These guidelines followed the "Grading of Recommendations, Assessment, Development, and Evaluation" (GRADE) methodology. We conducted a systematic literature review of PubMed, EMBASE, and the Cochrane Library for high-quality evidence published between 2020 and 2026. The panel developed 31 PICO questions that address key treatment considerations for moderate-to-severe psoriasis. RESULTS: We established 27 evidence-based recommendations and 4 good-practice statements addressing key aspects of moderate-to-severe psoriasis management. These guidelines strongly recommend adopting the Psoriasis Area and Severity Index (PASI) 90 as the primary treatment goal over PASI 75. For adult patients, the guidelines recommend biologic therapies, including interleukin (IL)-17 inhibitors, IL-23 inhibitors, IL-12/23 inhibitors, and tumor necrosis factor (TNF)-α inhibitors, for better disease control. For pediatric patients, the guidelines recommend early initiation of biologic therapy, with etanercept, secukinumab, ixekizumab, and adalimumab as preferred options. CONCLUSION: These Saudi national guidelines offer a comprehensive, evidence-based framework for managing moderate-to-severe psoriasis in adults and pediatric patients.
The CREST-2 trial demonstrated that carotid artery stenting combined with intensive medical management (IMM) significantly reduces stroke risk in patients with high-grade asymptomatic carotid stenosis compared with IMM alone. Careful patient selection and operator skill are critical factors for procedural success and can provide real-world validation of stenting as an important adjunct to IMM for stroke prevention. Continued advances in medical management and stenting are expected. It remains vital to engage in shared decision-making when considering moving forward with stenting of asymptomatic carotid stenosis.
Revista medica del Instituto Mexicano del Seguro SocialAngelica Jeanette Luevanos-Aguilera
Modern medical practice faces an ever-growing volume of information that demands accurate statistical interpretation to guide clinical decision-making. Effect measures are essential tools for quantifying the true magnitude of an intervention and assessing its clinical impact. However, limited understanding of these measures among healthcare professionals often hinders the effective translation of evidence into everyday practice. This article's objective is to provide a clear and didactic overview of the principal effect measures used in clinical research, emphasizing their relevance to evidence-based medicine. Key concepts such as the p-value, confidence intervals, relative risk, absolute risk reduction, and number needed to treat are summarized. The p-value reflects statistical significance, but it does not convey the magnitude or clinical importance of an effect. Confidence intervals, on the other hand, offer information about the precision and direction of the estimated effect. Relative risk facilitates the comparison of probabilities between groups, while absolute risk reduction and number needed to treat provide more tangible measures for clinical application. The adequate interpretation of these concepts is a cornerstone of evidence-based medicine, it enables clinicians to critically appraise research findings, and make patient-centered decisions, thereby narrowing the gap between scientific evidence and clinical practice.
Zeitschrift fur Psychosomatische Medizin und PsychotherapieRosa Butzlaff, Claudio Christoph, Lena Puhl, Emely Knaack, Stefan Bonhaus, Caroline Rometsch
Vagus Nerve Stimulation in the Treatment of Somatic Stress Disorder: Neurobiological Basis, Evidence Base and Prospects for Enhanced Psychotherapy Vagus nerve stimulation (VNS) has shown mixed but promising results for a number of neuropsychiatric conditions, such as depressive disorder, anxiety disorders, chronic pain and trauma- and stress-related disorders. However, the evidence to date on the use of VNS for somatic stress disorder is limited. Preliminary findings suggest that VNS influences physiological and psychological mechanisms that are also relevant to the pathophysiology of somatic stress disorder. Future studies should therefore specifically investigate whether VNS can be effectively used as an augmentative approach within psychotherapeutic or multimodal treatment programmes, in order to systematically assess the added benefit of VNS in the context of enhanced psychotherapy.
Canadian family physician Medecin de famille canadienWade Thompson, Arden R Barry, Lisa M McCarthy, Jeffrey Pan, Cayden Peixoto, Geneviève Lemay, Parag Goyal, Celeste Fung, Dar Dowlatshahi, Johanna Trimble, Ruth …
OBJECTIVE: To develop an evidence-based guideline to support clinicians in making decisions around continuation or discontinuation (deprescribing) of a statin for their older patients. METHODS: The target audience was clinicians. The scope was patients 65 years and older taking statins. Deprescribing was defined as discontinuation. The guideline was developed according to the Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework. The guideline panel included 10 clinicians (family physicians, pharmacists, a geriatrician, a cardiologist, a neurologist, and a nurse practitioner) and 1 patient and public member. There was a patient and public consultant group of 5 people 65 years and older taking statins. Recommendations were informed by evidence reviews on the benefits and harms of deprescribing versus continuation of statins; benefits and harms of initiating statins in older adults; feasibility, acceptability, equity, and patient preferences related to statin deprescribing; and resource implications of statin deprescribing. The team refined recommendations through consensus and synthesized clinical considerations relevant to practice. The guideline was reviewed by clinicians and interest holders, and their feedback was incorporated into the guideline. RECOMMENDATIONS: All decisions should be tailored to the individual and include a conversation with patients and carers. Decisions may be informed by consideration of function, mobility, cognition, level of frailty, social circumstances, life expectancy, pill burden, and patient values, preferences, and health care goals. The guideline panel suggests deprescribing statins in older adults at the end of life; continuing statins for primary prevention in older adults who are not at the end of life; continuing statins for secondary prevention in older adults who are not at the end of life; and offering a conversation about continuing or discontinuing statins for select patients. CONCLUSION: This guideline supports patient-centred decision making around statin use for older adults. The recommendations are meant to be discussed together with patients and carers to reach decisions that reflect individual patient characteristics, values, preferences, and health care goals.
Clinical and translational medicineBucur Maria, Eperjesi Orsolya, Panait Robert Iulian, Topala Mihaela, Babakhani Avin Aphrodite, Rancz Anett, Kói Tamás, Fazekas Karen, Obeidat Mahmoud, Papp Ren…
BACKGROUND: Ten percent of the global population presents impaired glucose tolerance. Although numerous interventions have been investigated to prevent type 2 diabetes (T2D), their comparative effectiveness remains uncertain. In this study, we assessed and ranked current pharmacological and non-pharmacological interventions for preventing diabetes in individuals with prediabetes. METHODS: The study protocol was registered on PROSPERO (CRD42023473875). Randomised controlled trials (RCTs) reporting on adult patients with prediabetes undergoing any intervention addressing dysglycaemia were eligible. Our systematic search was conducted from database inception to 19 December 2025 in three databases (MEDLINE, Embase and Cochrane Library [CENTRAL]). Network meta-analysis was performed using the random-effect frequentist method. Our primary outcomes were the incidence of T2D, haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and 2-h glucose after the glucose oral tolerance test (2hPG) expressed as relative risk (RR) and mean difference (MD), respectively, with the corresponding 95% confidence intervals (CIs). RESULTS: We included 378 RCTs comprising 113 122 patients. The highest risk reduction for T2D when compared with control was obtained with dual incretin-based therapy (glucagon-like peptide 1 [GLP-1] and gastric inhibitory polypeptide (GIP) receptor agonists [GLP-1 + GIP RAs]) (RR = .1, CI [.05; .21]), with GLP-1 receptor agonists (GLP-1 RAs) ranking second (RR = .26, CI [.19; .4]) followed closely by metformin plus intensive lifestyle intervention (ILI) (RR = .27, CI [.12; .64]). Only curcumin (MD = -.49, CI [-.70; -.28]), dual GLP-1 + GIP RA (MD = -.46, CI [-.63; -.29]), single GLP-1 RA (MD = -.41, CI [-.50; -.31]) and physical activity (MD = -.35, CI [-.48; -.23]) achieved >.3% HbA1c reductions after 1 year. Sulphonylureas and physical activity were most effective for the 1-year FPG decrease, while the greatest 2hPG reduction was obtained with zinc supplementation and sulphonylureas. CONCLUSION: Incretin-based therapies, particularly dual GLP-1 + GIP RA and single GLP-1 RA, followed by metformin together with ILI, are the most effective interventions to prevent T2D in patients with prediabetes.
Journal of evaluation in clinical practiceRobin J Evans
RATIONALE, AIMS AND OBJECTIVES: Medicine has never possessed more data, yet the conviction that understanding has deepened with it is difficult to sustain. This paper argues that the shortfall is conceptual rather than empirical and turns to the philosophy of science of William Whewell to name it. Evidence-based medicine tells clinicians how to weigh evidence once it is in hand. The paper aims to show that Whewell describes the earlier and harder task, the forming of the conceptions that make observations count as evidence in the first place. METHOD: The analysis is conceptual and historical. Whewell held that facts do not organise themselves but require colligation, the superinduction of a clarifying conception upon observations, and that discovery is most strongly warranted by consilience, the convergence of independent classes of fact upon a single cause. His account is read alongside Peirce on abduction and Fleck on how a scientific fact is held in place, illustrated through a case history of craniosynostosis from Virchow's law to the FGFR discoveries of the 1990s and applied to precision medicine, subspecialisation and artificial intelligence. RESULTS: In craniosynostosis, children moved between diagnostic categories and a new syndrome came into being without a single new observation, because a conception arrived that reorganised what existing observations were observations of. The contemporary difficulties are versions of the same problem. Precision medicine has delivered where a true cause was secured and stalled where it offered only correlation. Subspecialisation fragments enquiry so that consiliences crossing organ systems go unrecognised. Artificial intelligence extends the power of observation without extending the power of conception. CONCLUSION: Medicine has perfected the appraisal of evidence while leaving the formation of concepts largely to chance. The crisis is not one of insufficient data but of insufficient ideas. New conceptions come from prepared minds, and history and philosophy are part of that preparation.
Journal of evaluation in clinical practiceTakehiro Okabayashi, Ryo Inada, Toshi Imai, Kazuhide Ozaki, Kazutoshi Hayashi
RATIONALE: Evidence-Based Medicine (EBM) has strengthened clinical decision-making, but evidence alone cannot ensure that care is delivered safely, consistently, or in a manner that produces outcomes meaningful to patients. Patient safety, Quality Improvement (QI), Learning Health Systems (LHS), and Value-Based Healthcare (VBHC) have emerged to address these limitations. Understanding their relationships is important for healthcare systems seeking improvement and patient-centred care. AIMS AND OBJECTIVES: To examine the historical development and conceptual relationships among EBM, patient safety, QI, LHS, and VBHC, and to propose an integrated framework for understanding their complementary roles in healthcare quality. METHOD: A narrative review was conducted using PubMed as a database, supplemented by reference-list searching. Literature published from approximately 1990 to June 2026 was considered. Searches combined terms related to EBM, patient safety, QI, LHS, VBHC, implementation science, systems thinking, shared decision-making, quality of care, and healthcare transformation. Landmark publications, conceptual papers, guidelines, consensus statements, systematic reviews, and original studies were narratively synthesized. RESULTS: The review identifies a Five-Stage Evolution Framework: EBM establishes what works; patient safety addresses how effective care can be delivered safely; QI enables reliable and continuous improvement; LHS creates feedback loops that allow healthcare systems to learn from routine clinical practice; and VBHC evaluates whether these efforts generate outcomes that matter to patients relative to the resources required. These paradigms are complementary rather than competing approaches. Their integration also requires systems thinking, data literacy, interprofessional collaboration, shared decision-making, and attention to patient values and equity. Challenges include the evidence-to-practice gap, organizational barriers, data quality, algorithmic bias, privacy, and the difficulty of measuring individualized value. CONCLUSION: Modern healthcare should move beyond isolated quality initiatives toward an integrated system that generates evidence, delivers care safely, continuously learns and improves, and creates meaningful value for patients. The proposed framework is conceptual and requires empirical evaluation.
Journal of clinical apheresisNicole D Zantek, Caroline R Alquist, Jan C Hofmann, Reinhard Klingel, Yosef Levenbrown, Oluwatoyosi A Onwuemene, Gopal Patidar, Christopher J Patriquin, Jay S …
The American Society for Apheresis (ASFA) Journal of Clinical Apheresis (JCA) Special Issue Writing Committee is charged with reviewing, updating, and categorizing indications for the evidence-based use of therapeutic apheresis (TA) in human disease. As in recent editions, the Tenth Edition of the JCA Special Issue committee has incorporated systematic review and evidence-based approaches in the grading of evidence and categorization of apheresis indications to make recommendations on the use of apheresis in a wide variety of diseases and conditions. This edition has largely maintained the general layout and concept of a fact sheet introduced in the Fourth Edition (2007). Each fact sheet succinctly summarizes the evidence for the use of TA in a specific disease entity or medical condition. The Tenth Edition comprises 93 fact sheets and 183 graded and categorized indications. This includes two new fact sheets and several changes to indications, categorization, or grade on existing fact sheets. The Tenth Edition of the JCA Special Issue seeks to continue to serve as a key resource that guides the utilization of TA in the treatment of human disease.
Pain physicianLaxmaiah Manchikanti, Annu Navani, Sheldon Jordan, Mahendra R Sanapati, Sairam Atluri, Navneet Boddu, Kenneth D Candido, Alan D Kaye
BACKGROUND: Regenerative medicine is an evolving medical subspecialty dedicated to enhancing the body's natural healing mechanisms to repair or to replace damaged tissues. By using autologous or allogeneic biologics, it offers the potential to restore function where conventional therapies have shown limited success. While this field holds great promise and continues to generate enthusiasm among both patients and clinicians, it remains in early stages of clinical validation. Therefore, it must be approached with careful optimism and responsible application, ensuring that its presentation, promotion, and use in clinical settings are grounded in evidence and ethical standards. In 2025, the American Society of Interventional Pain Physicians (ASIPP) published updated comprehensive evidence-based guidelines. STUDY DESIGN: Summary and structured synthesis of a multidisciplinary, evidence-based clinical practice guideline developed by systematic literature review, dual-instrument methodologic quality appraisal, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) certainty assessment, and modified Delphi consensus. OBJECTIVES: The present investigation summarizes the 2025 updated comprehensive evidence-based guidelines for regenerative therapies in the management of chronic low back pain published by ASIPP. The critical and analytical summary is organized around these recommendations, presenting for each underlying evidence, the assigned evidence level, the consensus-based clinical recommendation, and the practical consequences for patient selection, product preparation and dosing, procedural technique, regulatory compliance, and informed consent. METHODS: A multidisciplinary panel convened by ASIPP defined key clinical questions, reviewed relevant literature, formulated evidence-based statements, and reached consensus through structured discussion and formal voting. Methodologic quality of randomized trials was assessed with Cochrane review criteria and the Interventional Pain Management Techniques - Quality Appraisal of Reliability and Risk of Bias (IPM-QRB) instrument; nonrandomized studies were assessed with the Risk of Bias in Non-Randomized Studies of Exposure (ROBINS-E) tool and IPM-QRBNR. Evidence was graded on the 5-level modified ASIPP scale and appraised for certainty under GRADE. Consensus required at least 80% agreement among eligible panelists without a primary conflict of interest. RESULTS: Thirty-five authors contributed and 33 participated in the formal consensus process. Nineteen recommendations were generated, all achieving 100% agreement. Effectiveness recommendations were graded by anatomical target: lumbar intradiscal injections of platelet-rich plasma (PRP) and of bone marrow aspirate concentrate (BMAC) each carry Level III, fair evidence with a moderate consensus-based recommendation; lumbar epidural PRP injections carry Level III, fair evidence with a moderate recommendation; facet joint PRP and mesenchymal stem cell (MSC) injections carry Level IV, limited evidence with a moderate recommendation; sacroiliac joint PRP injections carry Level IV, limited evidence with a low recommendation; and functional spine unit multitarget injections carry very low evidence with a low recommendation. The remaining recommendations address available therapies and regulatory status, the risks of unapproved stem cell products, quality and standards for PRP and BMAC preparation, minimum quality control measures and platelet dosing, patient education, administration criteria, procedural risk stratification, and antithrombotic management. LIMITATIONS: The scarcity of high-quality studies, with much available evidence derived from small or heterogeneous trials. CONCLUSION: Regenerative therapies for chronic low back pain rely on fair evidence at the intervertebral disc and epidural space and limited evidence at evidence for facet and sacroiliac joints. The panel issued moderate consensus-based recommendations for all biologics in the lumbar spine, conditioned on definitive diagnosis, failure of conservative therapy, adherence to Food and Drug Administration (FDA) regulation, quantitative verification of the injectate, and transparent informed consent covering the experimental nature and out-of-pocket cost of these treatments.