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.

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.

Factors influencing the reimbursement of cancer drugs in Europe: A scoping review.

RATIONALE: Reimbursement process of oncology drugs in Europe occurs within a complex decision-making process that varies between Member States. Distinctions between the States trigger societal debates since it is necessary to balance access to medicines and health systems sustainability. AIMS AND OBJECTIVES: We aimed to review the evidence concerning factors associated with the reimbursement decision or Health Technology Agency recommendation of oncology drugs in Europe. METHODS: A systematic literature search was performed in two databases from inception to august 2023. Screening and data extraction were performed by pairs. RESULTS: Thirteen articles were included and encompassed data from 11 nations. Seven articles showed that cost-effective (C-E) drugs and lower Incremental Cost-Effectiveness Ratios (ICERs) had higher likelihood of reimbursement. Disease severity might influence the reimbursement decision with financial agreements. Improvement in clinical outcomes, substantial clinical benefit (p < 0.01) or overall survival gains (p < 0.05) were positively associated. Orphan drug designation impact varies between countries but positive decisions are usually achieved under specific conditions. Clinical and C-E uncertainty frequently led to reimbursement with financial agreements or outcomes-based conditions. Sociodemographic factors as: social health insurance system, higher Gross Domestic Product and larger elderly population were positively associated with reimbursement (p < 0.01). CONCLUSION: There is a need for further research into key determinants of reimbursement decisions in Europe and the development of drug access models that can effectively address and overcome costs and effectiveness uncertainties.

Clinical decision support systems in addiction and concurrent disorders: A systematic review and meta-analysis.

INTRODUCTION: This review aims to synthesise the literature on the efficacy, evolution, and challenges of implementing Clincian Decision Support Systems (CDSS) in the realm of mental health, addiction, and concurrent disorders. METHODS: Following PRISMA guidelines, a systematic review and meta-analysis were performed. Searches conducted in databases such as MEDLINE, Embase, CINAHL, PsycINFO, and Web of Science through 25 May 2023, yielded 27,344 records. After necessary exclusions, 69 records were allocated for detailed synthesis. In the examination of patient outcomes with a focus on metrics such as therapeutic efficacy, patient satisfaction, and treatment acceptance, meta-analytic techniques were employed to synthesise data from randomised controlled trials. RESULTS: A total of 69 studies were included, revealing a shift from knowledge-based models pre-2017 to a rise in data-driven models post-2017. The majority of models were found to be in Stage 2 or 4 of maturity. The meta-analysis showed an effect size of -0.11 for addiction-related outcomes and a stronger effect size of -0.50 for patient satisfaction and acceptance of CDSS. DISCUSSION: The results indicate a shift from knowledge-based to data-driven CDSS approaches, aligned with advances in machine learning and big data. Although the immediate impact on addiction outcomes is modest, higher patient satisfaction suggests promise for wider CDSS use. Identified challenges include alert fatigue and opaque AI models. CONCLUSION: CDSS shows promise in mental health and addiction treatment but requires a nuanced approach for effective and ethical implementation. The results emphasise the need for continued research to ensure optimised and equitable use in healthcare settings.

American Rhinologic Society expert practice statement part 2: Postoperative precautions and management principles following endoscopic skull base surgery.

The goal of this American Rhinologic Society expert practice statement (EPS) is to summarize the best available evidence regarding postoperative precautions for patients following endoscopic skull base surgery for intradural pathology. These topics include the administration of postoperative nasal hygiene; patient mobilization and activity level; the resumption of continuous positive airway pressure in patients with obstructive sleep apnea; and the timing and capacity with which a patient may be subjected to barotrauma, such as air travel postoperatively. This EPS was developed following the recommended methodology and approval process as previously outlined. Given the diverse practices and limited agreement on the accepted principles regarding postoperative precautions for patients following skull base surgery, this EPS seeks to summarize the existing literature and provide clinically relevant guidance to bring clarity to these differing practice patterns. Following a modified Delphi approach, four statements were developed, all of which reached consensus. Because of the paucity of literature on these topics, these statements represent a summation of the limited literature and the experts' opinions. These statements and the accompanying evidence are summarized below, along with an assessment of future needs.

Clinical Guidelines on Compression Therapy in Venous Diseases.

BACKGROUND: In recent years, compression therapy has attracted gradually increasing clinical attention in lower extremity venous diseases. However, basic concepts and clear nomenclature, standard treatment methods, and consistent product standards for pressure equipment are lacking. Therefore, developing clinical guidelines for compression therapy is essential to improving the treatment of venous diseases. METHODS: Our panel generated strong (Grade I), moderate (Grade IIa and IIb), and weak (Grade III) recommendations based on high quality (Class A), moderate quality (Class B), and low quality (Class C) evidence, using the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) approach and the European Society of Cardiology (ESC) grading system. RESULTS: The panels made 30 recommendations from current evidence, focusing on seven fields of lower extremity venous disease (venous thromboembolism, post-thrombotic syndrome, chronic venous insufficiency, varicose veins, hemangioma and vascular malformations, lymphedema, and venous ulcers) and 18 topics. CONCLUSIONS: Of the 30 recommendations made across the 18 topics, 7 were strong (Grade I) and 17 were based on high quality (Class A) evidence, highlighting the need for further research of the use of compression therapy for .

Systematic reviews and meta-analyses in neurosurgery part I: interpreting and critically appraising as a guide for clinical practice.

Neurosurgeons are inundated with the Herculean task to keep abreast with the rapid pace at which clinical research is proliferating. Systematic reviews and meta-analyses (SRMAs) have consequently surged in popularity because when executed properly, they constitute the highest level of evidence, and may save busy neurosurgeons many hours of combing the literature. Well-executed SRMAs may prove instructive for clinical practice, but poorly conducted reviews sow confusion and may potentially cause harm. Unfortunately, many SRMAs within neurosurgery are relatively lackluster in methodological rigor. When neurosurgeons apply the results of an SRMA to patient care, they should start by evaluating the extent to which the employed methods have likely protected against misleading results. The present article aims to educate the reader about how to interpret an SRMA, to assess the potential relevance of its results in the special context of the neurosurgical patient population.

Architectural design of national evidence based medicine information system based on electronic health record.

BACKGROUND: The global implementation of Electronic Health Records has significantly enhanced the quality of medical care and the overall delivery of public health services. The incorporation of Evidence-Based Medicine offers numerous benefits and enhances the efficacy of decision-making in areas such as prevention, prognosis, diagnosis, and therapeutic approaches. OBJECTIVE: The objective of this paper is to propose an architectural design of an Evidence-Based Medicine information system based on the Electronic Health Record, taking into account the existing and future level of interoperability of health information systems in Greece. METHODS: A study of the suggested evidence-based medicine architectures found in the existing literature was conducted. Moreover, the interoperability architecture of health information systems in Greece was analyzed. The architecture design reviewed by specialized personnel and their recommendations were incorporated into the final design of the proposed architecture. RESULTS: The proposed integrated architecture of an Evidence-Based Medicine system based on the Electronic Health Record integrates and utilizes citizens' health data while leveraging the existing knowledge available in the literature. CONCLUSIONS: Taking into consideration the recently established National Interoperability Framework, which aligns with the European Interoperability Framework, the proposed realistic architectural approach contributes to improving the quality of healthcare provided through the ability to make safe, timely and accurate decisions by physicians.

Management, development and methodology of the Clinical Practice Guidelines and Recommendations of the Spanish Society of Rheumatology.

The Spanish Society of Rheumatology (SER) brings together the majority of Spain's rheumatologists and, among the many services it offers its members, has a Research Unit (RU). This unit provides methodological support to SER members in clinical and epidemiological research, coordinates and carries out research projects, designs and maintains large patient databases, develops qualitative research projects and produces evidence-based medicine (EBM) documents. Through this last activity, the RU of the SER produces clinical practice guidelines and recommendation documents on topics relevant to rheumatology that meet the most demanding methodological standards. The aim of this article is to describe the management process and methodology followed by the UI of the SER to identify the topics of its EBM documents and how it executes and develops its guidelines and recommendations.

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.

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.

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.

Challenges, barriers and solutions for implementing clinical practice guidelines: a qualitative study in southern Iran.

BACKGROUND: Identifying the challenges of implementing clinical practice guidelines (CPGs) can provide valuable information for decision-makers and health policymakers at the national and local levels. The implementation of CPGs requires the development of strategies to facilitate their use. This research aimed to determine the challenges, barriers and solutions for implementing CPGs from the expert point of view in Bushehr University of Medical Sciences. METHODS: This qualitative research uses content analysis conducted in 2022 in southern Iran. In-depth interviews were conducted with the physicians and experts in the health system. Interviewing continued until reaching the saturation level. Altogether, 22 experts were interviewed. The interview guide was used to explore experts' opinions. All the interviews were recorded and then transcribed. Finally, coding and data analysis was done using MAXQDA 2022 software. RESULTS: The analysis revealed 4 main themes and 20 subthemes. The four main themes included challenges related to physicians, medical education, the health system and patients. The most common themes were the lack of sufficient training (related to the medical education system), equipment and infrastructure, and the lack of adaptation of clinical guidelines (related to the health system). The solutions included 4 main themes and 19 subthemes. CONCLUSION: The most mentioned topic by the experts was training CPGs in medical schools. In Iran's current medical education system, the training of CPGs is not included in the curriculum. It is proposed to reform the medical education system in Iran. In addition, health inequalities such as lack of access to equipment, supplies and insurance in under-resourced areas and disparities in research/training/medical education should be addressed to improve the validity of guidelines.

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.