Methodological Considerations in Evaluating Breast Cancer Screening Studies.

In evidence-based medicine frameworks, the highest level of evidence is derived from quantitative synthesis of double-masked, high-quality, randomly assigned controlled trials. Meta-analyses of randomly assigned controlled trials have demonstrated that screening mammography reduces breast cancer deaths. In the United States, every major guideline-producing organization has recommended screening mammography in average-risk women; however, there are controversies about age and frequency. Carefully controlled observational research studies and statistical modeling studies can address evidence gaps and inform evidence-based, contemporary screening practices. As breast imaging radiologists develop and evaluate existing and new screening tests and technologies, they will need to understand the key methodological considerations and scientific criteria used by policy makers and health service researchers to support dissemination and implementation of evidence-based screening tests. The Wilson and Jungner principles and the U.S. Preventive Services Task Force general analytic framework provide structured evaluations of the effectiveness of screening tests. Key considerations in both frameworks include public health significance, natural history of disease, cost-effectiveness, and characteristics of screening tests and treatments. Rigorous evaluation of screening tests using analytic frameworks can maximize the benefits of screening tests while reducing potential harms. The purpose of this article is to review key methodological considerations and analytic frameworks used to evaluate screening studies and develop evidence-based recommendations.

Longevity of posterior direct versus indirect composite restorations: A systematic review and meta-analysis.

OBJECTIVES: The goal of this systemic review and meta-analysis was to compare the longevity of direct and indirect composite restorations in posterior teeth. DATA: Randomized controlled trials (RCT) investigating direct and indirect composite restorations in permanent posterior teeth. SOURCES: Three electronic databases (PubMed, CENTRAL (Cochrane) and Embase) were screened. No language or time restrictions were applied. Study selection, data extraction and quality assessment were done in duplicate. Risk of bias and level of evidence was graded using Risk of Bias 2.0 tool and Grade Profiler 3.6. RESULTS: A total of 3056 articles were found by electronic databases. Finally, five RCTs were selected. Overall, 627 restorations of which 323 were direct and 304 indirect composite restorations have been placed in 279 patients (age: 28-81 years). The highest annual failure rates (AFR) were found for indirect restorations ranging from 0 % to 15.5 %. Lower AFR were found for direct restorations ranging from 0 % to 5.4 %. The most frequent failures were found to be chipping and fracture of the restoration followed by caries. Meta-analysis revealed that the failure rate for direct restorations was significantly lower than for indirect restorations (Risk Ratio (RR) [95 %CI] = 0.61 [0.47; 0.79]; very low level of evidence). Furthermore, all studies showed a high risk of bias. CONCLUSION: Direct and indirect composite restorations can be recommended for large class II cavities including cusp coverage in posterior teeth for single tooth restoration. Meta-analysis revealed significantly lower relative risk to fail for direct composite restorations than for indirect restorations but results are with high risk of basis.

The Role of Cannabinoids in Advancing Cancer Treatment: Insights from Evidence-Based Medicine.

PURPOSE OF REVIEW: This document critically examines the role of cannabinoids in cancer care during an era marked by rapid advancements in oncology and changing perceptions on cannabis. It traces the historical context of cannabis in medicinal use, navigating its journey from widespread acceptance, subsequent criminalization, to its resurgence in modern therapeutic applications, particularly within the framework of Evidence-Based Medicine (EBM). RECENT FINDINGS: Anchored in EBM principles, this study synthesizes current research from clinical trials, systematic reviews, and meta-analyses to evaluate the efficacy and safety of cannabinoids in oncology. The focus is on their palliative effects, considering the nuances of effectiveness, risk assessment, and challenges inherent in translating these findings into clinical guidelines. The study seeks to bridge the gap between scientific research and clinical practice, offering insights to inform future oncological therapies and symptom management strategies involving cannabinoids. The potential benefits and risks of cannabinoid use in cancer treatment are assessed to guide clinicians and researchers in developing comprehensive, evidence-based approaches to patient care.

Effect of Face Masking on Transmission of SARS-CoV-2.

The efficacy of face masking for the public is not convincing to prevent the transmission of respiratory tract viruses such as SARS-CoV-2 when the criteria of evidence-based medicine are applied. This finding is mainly explained by the results from randomized-controlled trials (RCTs) when a high prevalence of the infection and a high compliance in mask wearing was assured. Throughout these studies no significant protective effect was observed. Observational studies with surgical masks describe a significant protective effect, but are prone to confounders such as physical distance. Respirators do not provide an additional health benefit compared to surgical or medical masks (RCTs). Community masks can even increase the risk of infection (RCTs). Based on the categories of evidence-based medicine, the efficacy results can best be categorized as conflicting evidence. Many relevant adverse events are described when masks are worn for hours such as dyspnea (12.2-52.8%), headache (3.9-73.4%), pruritus (0.0-60.0%), and skin reactions (0.0-85.0%). Their frequency is often higher with respirators. In future pandemics, masks should only be recommended or mandated for settings in which a clinically relevant health benefit can be expected, defined as the prevention of severe, critical or fatal disease, that clearly outweighs the expectable associated adverse reactions.

Scores and sores: Exploring patient-reported outcomes for knee evaluation in orthopaedics, sports medicine and rehabilitation.

Recognizing and addressing the controversies surrounding using patient-reported outcome measures (PROMs) is crucial for enhancing evaluation standards in clinical studies in orthopedics, sports medicine, and rehabilitation. The article comprehensively described the challenges of using PROMs to evaluate knee conditions in these fields. Apart from defining and characterizing patient-reported outcomes and their measures, the article discussed controversies around them, such as using them as primary outcomes. It highlighted the importance of standardizing and validating PROMs. Several initiatives taken to improve the selection of appropriate outcomes for clinical research purposes were described. Additionally, the potential of technology, mainly digital health tools and mobile applications, was mentioned in the context of enhancing the collection and analysis of PROMs. The article also raised the issue of the readability of PROMs, defined as the ease with which they can be read and understood by patients. The article concluded that adopting a complementary approach to treatment evaluation by integrating subjective and objective measures is imperative for accurately assessing efficacy. This comprehensive approach provides a more holistic understanding of patient outcomes, forms the foundation for evidence-based medicine, and informs future healthcare policies. Proactive measures are urgently needed to address concerns and improve the reliability and validity of PROMs for clinical practice and research. LEVEL OF EVIDENCE: level V.

Concepts for the development of person-centred, digitally-enabled, Artificial Intelligence-assisted ARIA care pathways (ARIA 2024).

The traditional healthcare model is focused on diseases (medicine and natural science) and does not acknowledge patients' resources and abilities to be experts in their own life based on their lived experiences. Improving healthcare safety, quality and coordination, as well as quality of life, are important aims in the care of patients with chronic conditions. Person-centred care needs to ensure that people's values and preferences guide clinical decisions. This paper reviews current knowledge to develop (i) digital care pathways for rhinitis and asthma multimorbidity and (ii) digitally-enabled person-centred care (1). It combines all relevant research evidence, including the so-called real-world evidence, with the ultimate goal to develop digitally-enabled, patient-centred care. The paper includes (i) Allergic Rhinitis and its Impact on Asthma (ARIA), a two-decade journey, (ii) Grading of Recommendations, Assessment, Development and Evaluation (GRADE), the evidence-based model of guidelines in airway diseases, (iii) mHealth impact on airway diseases, (iv) from guidelines to digital care pathways, (v) embedding Planetary Health, (vi) novel classification of rhinitis and asthma, (vi) embedding real-life data with population-based studies, (vii) the ARIA-EAACI strategy for the management of airway diseases using digital biomarkers, (viii) Artificial Intelligence, (ix) the development of digitally-enabled ARIA Person-Centred Care and (x) the political agenda. The ultimate goal is to propose ARIA 2024 guidelines centred around the patient in order to make them more applicable and sustainable.

Lessons from a geriatric clinical case from the 19th century: a bridge to modern geriatric medicine.

Count Neipperg (1775-1829), the morganatic husband of Maria Luigia of Habsburg, Napoleon's former wife, presented with typical heart failure symptoms and died of bilateral bronchopneumonia. Neipperg's case is an example of the conflict in the medical field, which led to the birth of modern evidence-based medicine (EBM), and although Neipperg died almost 200 years ago, his case presents the same critical issues that more complex geriatric patients face today. First, the attending physicians provided divergent opinions without reaching an agreement. For example, Francesco Rossi correctly diagnosed heart disease by evaluating the patient's signs and symptoms, a clinical approach that is an early example of modern EBM. By contrast, Giacomo Tommasini made a misdiagnosis based on the philosophical principles of John Brown's vitalist theory, as reworded by Giovanni Rasori. Second, Tommasini's medical report also includes evidence of the Geriatric 5Ms for older patient care, such as multi-complexity, multimorbidity, medication, mobility, and the mind. Moreover, both physicians considered "what matters most" for the patient and his family. Third, the Count's status and political role were identified as the social and structural determinants of health (SSDoH) and used to justify the exceptional intensity of the health care provided. Subsequently, the ante litteram application of EBM and a clinical evaluation based on Geriatrics 5Ms principles anticipate current multidisciplinary management focused on the patient rather than a single disease. The systematic revision of past clinical cases not examined before could open new windows in the dissemination of the geriatric methodology and discipline.

The McMaster Health Information Research Unit: Over a Quarter-Century of Health Informatics Supporting Evidence-Based Medicine.

Evidence-based medicine (EBM) emerged from McMaster University in the 1980-1990s, which emphasizes the integration of the best research evidence with clinical expertise and patient values. The Health Information Research Unit (HiRU) was created at McMaster University in 1985 to support EBM. Early on, digital health informatics took the form of teaching clinicians how to search MEDLINE with modems and phone lines. Searching and retrieval of published articles were transformed as electronic platforms provided greater access to clinically relevant studies, systematic reviews, and clinical practice guidelines, with PubMed playing a pivotal role. In the early 2000s, the HiRU introduced Clinical Queries-validated search filters derived from the curated, gold-standard, human-appraised Hedges dataset-to enhance the precision of searches, allowing clinicians to hone their queries based on study design, population, and outcomes. Currently, almost 1 million articles are added to PubMed annually. To filter through this volume of heterogenous publications for clinically important articles, the HiRU team and other researchers have been applying classical machine learning, deep learning, and, increasingly, large language models (LLMs). These approaches are built upon the foundation of gold-standard annotated datasets and humans in the loop for active machine learning. In this viewpoint, we explore the evolution of health informatics in supporting evidence search and retrieval processes over the past 25+ years within the HiRU, including the evolving roles of LLMs and responsible artificial intelligence, as we continue to facilitate the dissemination of knowledge, enabling clinicians to integrate the best available evidence into their clinical practice.

Is evidence-based practice justified?-A philosophical critique.

BACKGROUND: Evidence-based practice is the principle governing a range of healthcare practices and beyond. However, it has suffered from a lack of philosophical rigour. This paper sets out to analyse the epistemological basis of evidence-based practice. METHOD: The paper uses a conceptual analysis. First, it describes the implicit epistemology at work in evidence-based practice. Second, it evaluates the implicit epistemological basis. RESULTS: The analysis indicates that evidence-based practice lacks an explicit epistemological basis. It shows, moreover, that the implicit epistemological basis is untenable. CONCLUSION: There is a need to re-think the epistemological basis for evidence-based practice. Evidence-based practice is out of touch with developments within philosophy of science.

The Potential of Evidence-Based Clinical Intake Tools to Discover or Ground Prevalence of Symptoms Using Real-Life Digital Health Encounters: Retrospective Cohort Study.

BACKGROUND: Evidence-based clinical intake tools (EBCITs) are structured assessment tools used to gather information about patients and help health care providers make informed decisions. The growing demand for personalized medicine, along with the big data revolution, has rendered EBCITs a promising solution. EBCITs have the potential to provide comprehensive and individualized assessments of symptoms, enabling accurate diagnosis, while contributing to the grounding of medical care. OBJECTIVE: This work aims to examine whether EBCITs cover data concerning disorders and symptoms to a similar extent as physicians, and thus can reliably address medical conditions in clinical settings. We also explore the potential of EBCITs to discover and ground the real prevalence of symptoms in different disorders thereby expanding medical knowledge and further supporting medical diagnoses made by physicians. METHODS: Between August 1, 2022, and January 15, 2023, patients who used the services of a digital health care (DH) provider in the United States were first assessed by the Kahun EBCIT. Kahun platform gathered and analyzed the information from the sessions. This study estimated the prevalence of patients' symptoms in medical disorders using 2 data sets. The first data set analyzed symptom prevalence, as determined by Kahun's knowledge engine. The second data set analyzed symptom prevalence, relying solely on data from the DH patients gathered by Kahun. The variance difference between these 2 prevalence data sets helped us assess Kahun's ability to incorporate new data while integrating existing knowledge. To analyze the comprehensiveness of Kahun's knowledge engine, we compared how well it covers weighted data for the symptoms and disorders found in the 2019 National Ambulatory Medical Care Survey (NMCAS). To assess Kahun's diagnosis accuracy, physicians independently diagnosed 250 of Kahun-DH's sessions. Their diagnoses were compared with Kahun's diagnoses. RESULTS: In this study, 2550 patients used Kahun to complete a full assessment. Kahun proposed 108,523 suggestions related to symptoms during the intake process. At the end of the intake process, 6496 conditions were presented to the caregiver. Kahun covered 94% (526,157,569/562,150,572) of the weighted symptoms and 91% (1,582,637,476/173,4783,244) of the weighted disorders in the 2019 NMCAS. In 90% (224/250) of the sessions, both physicians and Kahun suggested at least one identical disorder, with a 72% (367/507) total accuracy rate. Kahun's engine yielded 519 prevalences while the Kahun-DH cohort yielded 599; 156 prevalences were unique to the latter and 443 prevalences were shared by both data sets. CONCLUSIONS: ECBITs, such as Kahun, encompass extensive amounts of knowledge and could serve as a reliable database for inferring medical insights and diagnoses. Using this credible database, the potential prevalence of symptoms in different disorders was discovered or grounded. This highlights the ability of ECBITs to refine the understanding of relationships between disorders and symptoms, which further supports physicians in medical diagnosis.

Guidance on how to efficiently find, choose, and use available systematic reviews was developed.

OBJECTIVES: The aim of this paper is to provide clinicians and authors of clinical guidelines or patient information with practical guidance on searching and choosing systematic reviews(s) (SR[s]) and, where adequate, on making use of SR(s). STUDY DESIGN AND SETTING: At the German conference of the Evidence-Based Medicine Network (EbM Network) a workshop on the topic was held to identify the most important areas where guidance for practice appears necessary. After the workshop, we established working groups. These included SR users with different backgrounds (eg, information specialists, epidemiologists) and working areas. Each working group developed and consented a draft guidance based on their expert knowledge and experiences. The results were presented to the entire group and finalized in an iterative process. RESULTS: We developed a practical guidance that answers questions that usually arise when choosing and using SR(s). (1) How to efficiently find high-quality SRs? (2) How to choose the most appropriate SR? (3) What to do if no SR of sufficient quality could be identified? In addition, we developed an algorithm that links these steps and accounts for their interaction. The resulting guidance is primarily directed at clinicians and developers of clinical practice guidelines or patient information resources. CONCLUSION: We suggest practical guidance for making the best use of SRs when answering a specific research question. The guidance may contribute to the efficient use of existing SRs. Potential benefits when using existing SRs should be always weighted against potential limitations.

Systematic reviews and meta-analyses in neurosurgery Part II: a guide to designing the protocol.

Despite clearly established guidelines, recent audits have found the conduct and reporting of systematic reviews and meta-analyses (SRMAs) within neurosurgery to be relatively lackluster in methodological rigor and compliance. Protocols of SRMAs allow for planning and documentation of review methods, guard against arbitrary decision-making during the review process, and enable readers to assess for the presence of selective reporting. To aid transparency, authors should provide sufficient detail in their protocol so that the readers could reproduce the study themselves. Development of our guideline drew heavily from the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols (PRISMA-P) initiative. The objective of this article is not to enumerate every detail of this checklist, but to provide guidance to authors preparing their protocol, with examples, for a systematic review in neurosurgery. Particularly, we emphasize on the PICO framework - population (P), interventions (I), comparators (C), outcomes (O) - which is central to constructing a clinical question, defining the scope of the systematic review, defining and prioritizing the primary outcome, to specifying the eligibility criteria, designing the search strategy, and identifying potential sources of heterogeneity. We encourage our readers to make use of this guideline alongside the PRISMA-P 2015 statement, when drafting and appraising systematic review protocols.

Relevance and Premises of Values-Based Practice for Decision Making in Brain Health.

Brain health is a complex concept, shaped by a plethora of determinants related to physical health, healthy environments, safety and security, learning and social connection, as well as access to quality healthcare services. Decision-making in this complex field is characterized by diverse values, potentially conflicting interests, and asymmetrically influential stakeholders. Values-based practice (VBP) is a toolkit for balancing values in a democratic and inclusive way, so that every stakeholder feels a sense of ownership over the decision made. In VBP, the emphasis is on good process rather than on pre-determined 'correct' outcomes. Based on two case vignettes, we highlight the relevance of the ten principles of VBP for balancing different values to the satisfaction of those directly concerned, in a given decision-making process. In addition, we argue that the successful implementation of VBP in the complex area of brain health, as well as in other fields, is premised on higher order values (meta-values), beyond mutual respect and the legal, regulatory, and bioethical framework. These include mutual regard, reciprocity, autonomy, and an egalitarian attitude towards VBP procedures and involved stakeholders.

Top Ten Tips Palliative Care Clinicians Should Know About Interpreting a Clinical Trial.

Evidence-based practice is foundational to high-quality palliative care delivery. However, the clinical trials that compose the evidence base are often methodologically imperfect. Applying their conclusions without critical application to the clinical practice context can harm patients. The tips provided can help clinicians infer judiciously from clinical trial results and avoid credulously accepting findings without critique. We suggest that statistical and mathematical expertise is unnecessary, but rather a keen curiosity about investigators' rationale for certain design choices and how these choices can affect results is key. For a more comprehensive understanding of clinical trials, this article can be used with the authors' corresponding ten tips article that focuses on designing a clinical trial.

The evidence base of the ten most prescribed drugs in England, France and the United States: a scoping review.

OBJECTIVE: To evaluate whether there is evidence of efficacy of the most commonly used medications in their primary indications. STUDY DESIGN AND SETTING: This scoping review was executed utilizing the Cochrane library and MEDLINE databases up to May 2023. The ten most prescribed medications in England, France, and the USA were identified using country-specific public databases. Up to three common indications in primary care were defined for each medication, based on a survey of general practitioners. The outcomes were determined by the authors to be patient-important outcomes, with placebo as the comparator. Two investigators independently conducted searches, following a predefined algorithm, to identify randomized controlled trials (RCTs) or meta-analyses of RCTs assessing the efficacy of these medications for each indication. The risk of bias was assessed using the ROBIS or ROB 2.0 tools. RESULTS: We identified 21 drugs, covering 56 indications and 114 outcomes. Sixty-seven percent of the evaluated medications demonstrated efficacy for at least one outcome in at least one of the sought indications. Overall, evidence of efficacy was found for 48% of the indications. There was no study evaluating the efficacy of amoxicillin and salbutamol. For other drugs such as phloroglucinol or cholecalciferol, available studies suggested an absence of efficacy in the most common indications. CONCLUSION: This study underscores the lack of data regarding the level of evidence for the most prescribed medications. Limitations include the choice of outcomes, and the understanding that the absence of evidence is not synonymous with the absence of efficacy.

Unnecessary care in orthopaedic surgery.

Unnecessary care, where the potential for harm exceeds the potential for benefit, is widespread in medical care. Orthopaedic surgery is no exception. This has significant implications for patient safety and health care expenditure. This narrative review explores unnecessary care in orthopaedic surgery. There is wide geographic variation in orthopaedic surgical practice that cannot be explained by differences in local patient populations. Furthermore, many orthopaedic interventions lack adequate low-bias evidence to support their use. Quantifying the size of the problem is difficult, but the economic burden and morbidity associated with unnecessary care is likely to be significant. An evidence gap, evidence-practice gap, cognitive biases, and health system factors all contribute to unnecessary care in orthopaedic surgery. Unnecessary care is harming patients and incurring high costs. Solutions include increasing awareness of the problem, aligning financial incentives to high value care and away from low value care, and demanding low bias evidence where none exists.

Randomized-controlled trials are methodologically inappropriate in adolescent transgender healthcare.

Background: Despite multiple rigorous observational studies documenting the association between positive mental health outcomes and access to puberty blockers, hormone therapy, and transition-related surgeries among adolescents, some jurisdictions have banned or are attempting to ban gender-affirming medical interventions for minors due to an absence of randomized-controlled trials (RCTs) proving their mental health benefits. Methods: This article critically reviews whether RCTs are methodologically appropriate for studying the association between adolescent gender-affirming care and mental health outcomes. Results: The scientific value of RCTs is severely impeded when studying the impact of gender-affirming care on the mental health of trans adolescent. Gender-affirming interventions have physiologically evident effects and are highly desired by participants, giving rise to concerns over adherence, drop-out, response bias, and generalizability. Complementary and well-designed observational studies can instead be used to ground reliable recommendations for clinical practice and policymaking in adolescent trans healthcare, without the need for RCTs. Conclusion: The lack of RCTs on the mental health impacts of gender-affirming care for trans adolescents does not entail that gender-affirming interventions are based on insufficient evidence. Given the methodological limitations of RCTs, complementary and well-designed observational studies offer more reliable scientific evidence than RCTs and should be considered of sufficient quality to guide clinical practice and policymaking.

Summary of the Clinical Evidence for Non-Pharmacological Management of Postoperative Delirium in Adults: An Evidence Synthesis.

Objective: To retrieve, evaluate, and summarise the clinical evidence for non-pharmacological interventions in adult postoperative delirium (POD), encompassing the preoperative, intraoperative, and postoperative phases. Methods: The methods included conducting searches on UpToDate Clinical Consultants, the Scottish Intercollegiate Guidelines Network, the National Institute for Health and Care Excellence, the Registered Nurses' Association of Ontario, BMJ Best Practice, the Cochrane Library, Web of Science, PubMed, China National Knowledge Infrastructure, Wanfang, VIP, and the Chinese Biomedical Literature Service System. Clinical practice guidelines, clinical decision-making, evidence summaries, evidence synthesis, expert consensus, systematic reviews, and meta-analyses on non-pharmacological interventions for adult POD were examined, and the search period spanned between the establishment of each database and 30 October 2023. Results: A total of 17 documents were included, comprising three guidelines, one expert consensus, one clinical decision-making article, four evidence summaries, three systematic reviews, and five meta-analyses. These documents primarily focused on the following three aspects: preoperative, intraoperative, and postoperative care. In total, 30 "best evidence" instances were compiled. Conclusion: Considering the complexity and potential harm of adult POD, an accurate and timely evaluation of high-risk factors, alongside effective medical nursing strategies, is vital in its prevention and treatment. Non-pharmacological interventions remain the preferred choice for preventing and treating POD. Medical institutions should establish standardised processes for non-pharmacological intervention in adult POD, based on evidence-based medicine, to enhance the level of clinical care in this field.

Summary of the best evidence for prehabilitation management of patients with non-small cell lung cancer.

Objective: This study adopts an evidence-based methodology to establish a comprehensive theory foundation for preoperative prehabilitation management in non-small cell lung cancer (NSCLC) patients. Methods: A systematic literature review linked to prehabilitation management for NSCLC patients was conducted, utilizing reputable databases such as UpToDate, BMJ Best Practice, UK NICE, SIGN, GIN, Joanna Briggs Institute Library, Cochrane Library, Web of Science, Embase, OVID evidence-based database, PubMed, Chinese Wanfang database, CNKI, CBM, ATS, BTS, AACVPR, and EACTS. The search encompassed articles, including clinical decision-making, guidelines, evidence summaries, expert consensuses, and systematic reviews, from the inception of databases up to March 31st, 2023. Two researchers performed quality assessment of the literature and subsequent evidence extraction. Results: Nineteen articles were included, comprising five guidelines, three expert consensuses, seven systematic reviews, and four randomized controlled trials. A total of 41 pieces of evidence were summarized, addressing key aspects such as the multidisciplinary team, appropriate patient population, prehabilitation modes, timing of prehabilitation, prehabilitation assessment, prehabilitation content, quality control, and effectiveness evaluation. Conclusions: The synthesis of the best evidence for prehabilitation management in NSCLC patients provides a solid evidence-based foundation for its implementation. It is recommended that healthcare professionals conduct thorough patient evaluations, optimize and integrate medical resources, and collaboratively engage in interdisciplinarity efforts to develop and implement personalized and multimodal prehabilitation plans.