LEVELS OF EVIDENCE IN ONCOLOGIC-ORTHOPEDIC STUDIES - ACTA ORTOP BRAS (1993-2022).

OBJECTIVES: to identify oncological-orthopedic studies published in Acta Ortopédica Brasileira over three decades; to classify them according to the type and level of evidence (LE); to observe the inter-rater agreement in the classification of studies; to analyze the studies retrospectively, according to levels of evidence; and to outline the evolution of the evidence in the study period. METHODS: Descriptive analyses were performed with absolute and relative frequencies of studies published between 1993 and 2022. Inter-rater agreement was analyzed by percentage of agreement and Kappa statistic (95%CI). The interpretation of the magnitude of the agreement was performed according to Landis & Koch. The association between classifications and publication period was analyzed using Fisher's exact test. The analyses were performed using the R program (significance of 5%). RESULTS: 69/1349 papers were selected; there was a significant association between type of study, statistical methodology, and LE with publication period (p < 0.05); inter-rater agreement regarding LE was 92.8%. CONCLUSIONS: Oncological-orthopedic studies accounted for 5.1% of all published papers. Regarding the LE, 80% were NE IV and V studies, despite the evolution observed between the first and last decade (decrease in LE V studies and increase in LE II, III and IV). Level of Evidence III, Retrospective Comparative Study.

OBJETIVOS: identificar estudos oncológico-ortopédicos publicados na Acta Ortopédica Brasileira ( Acta Ortop Bras ) ao longo de três décadas; classificá-los quanto ao tipo e nível de evidência (NE); observar a concordância interavaliadores na classificação dos estudos; analisar os trabalhos retrospectivamente, de acordo com níveis de evidência; e traçar os perfis evolutivos das evidências no período avaliado. Métodos: Realizou-se análises descritivas com frequências absolutas e relativas dos estudos publicados entre 1993 e 2022. A concordância interavaliadores foi analisada pela porcentagem de concordância e estatística Kappa (IC95%). A interpretação da magnitude da concordância foi realizada de acordo com Landis & Koch. A associação entre classificações e período de publicação foi analisada pelo teste exato de Fisher. As análises foram realizadas no programa R (significância de 5%). RESULTADOS: foram selecionados 69 de um total de 1349 artigos; houve associação significativa entre tipo de estudo, metodologia estatística e NE com período de publicação (p < 0,05); a concordância interavaliadores quanto ao NE foi de 92,8%. Conclusões: Os estudos oncológico-ortopédicos corresponderam a 5,1% de todos os artigos publicados. Quanto ao NE, 80% foram estudos NE IV e V, apesar da evolução observada entre a primeira e a última década (decréscimo de estudos NE V e aumento de NE II, III e IV). Nível de Evidência III, Estudo Retrospectivo Comparativo.

Gender, Pediatric Care, and Evidence.

This letter responds to the Other Voices commentaries "Troubling Trends in Health Misinformation Related to Gender-Affirming Care," by Stef M. Shuster and Meredithe McNamara; "Values and Evidence in Gender-Affirming Care," by Os Keyes and Elizabeth Dietz; "Breaking Binaries: The Critical Need for Feminist Bioethics in Pediatric Gender-Affirming Care," by Lisa Campo-Engelstein, Grayson Jackson, and Jacob Moses; and "Minors Lack the Autonomy to Consent to Gender-Affirming Care: Best Interests Must Be Primary," by John C. Bester, in the May-June 2024 issue of the Hastings Center Report.

Evidence-Based Medicine as Perceived by Healthcare Professionals: A Cross-Sectional Study in the United Arab Emirates.

BACKGROUND: To investigate evidence-based medicine (EBM) use by physicians and pharmacists in the United Arab Emirates (UAE). METHOD: A cross-sectional study using a validated questionnaire. Results: Overall, 70.7% of physicians and 35.3% of pharmacists had positive attitude toward EBM. Physicians with 10-15 years of professional experience scored highest on EBM implementation; no statistical association was found (p = 0.099). Younger pharmacists aged 25-35 years were more interested in implementing EBM compared to older pharmacists (p = 0.011). Physicians in Al Ain performed better than those in other cities (p < 0.0001), and pharmacists in Abu Dhabi implemented EBM better than others (p = 0.014). CONCLUSION: Age and years of experience could influence implementing EBM.

Ethical challenges for Health Technology Assessment (HTA) in the evolving evidence landscape.

Since its inception, Health Technology Assessment (HTA) has typically determined the value of a technology by collecting information derived from randomized clinical trials (RCTs), in line with the principles of evidence-based medicine (EBM). However, data from RCTs did not constitute the sole source of information, as other types of evidence (such as primary qualitative research) have often been utilized. Recent advances in both generating and collecting other types of evidence are broadening the landscape of evidence, adding complexity to the discussion of "robustness of evidence." What are the consequences of these recent developments for the methodology and conduct of HTA, the HTA community, and its ethical commitments? The aim of this article is to explore some ethical challenges that are emerging in the current evolving evidence landscape, particularly changes in evidence generation and collection (e.g., diversification of data sources), and shifting standards of evidence in the field of HTA (e.g., increasing acceptability of evidence that is thought of as lower quality). Our conclusion is that deciding how to best maintain trustworthiness is common to all these issues.

International Society for Diseases of the Esophagus consensus on management of the failed fundoplication.

Fundoplication is a durable, effective, and well-accepted treatment for gastroesophageal reflux disease. Nonetheless, troublesome postoperative symptoms do occasionally occur with management varying widely among centers. In an attempt to standardize definition and management of postfundoplication symptoms, a panel of international experts convened by the Guidelines Committee of the International Society for Diseases of the Esophagus devised a list of 33 statements across 5 domains through a Delphi approach, with at least 80% agreement to establish consensus. Eight statements were endorsed for the domain of Definitions, four for the domain of Investigations, nine for Dysphagia, nine for Heartburn, and four for Revisional surgery. This consensus defined as the treatment goal of fundoplication the resolution of symptoms rather than normalization of physiology or anatomy. Required investigations of all symptomatic postfundoplication patients were outlined. Further management was standardized by patients' symptomatology. The appropriateness of revisional fundoplication and the techniques thereof were described and the role of revisional surgery for therapies other than fundoplication were assessed. Fundoplication remains a frequently-performed operation, and this is the first international consensus on the management of various postfundoplication problems.

Cannabinoids as a Natural Alternative for the Management of Neuropathic Pain: A Systematic Review of Randomized Placebo-Controlled Trials.

Dysfunction or damage to the nervous system may develop into and result in a chronic pain condition known as neuropathic pain. Neuropathic pain is defined as the structural and functional alteration of the somatosensory component of the nervous system. The treatment of neuropathic pain is a complex endeavor, which often requires specialist care and intensive drug therapy. Recently, cannabinoids have emerged as an alternative and natural option for the treatment of chronic pain, with tetrahydrocannabinol (THC) and cannabidiol (CBD) being the most extensively studied neuroactive components. The therapeutic potential of cannabis remains largely underexplored, primarily due to its social stigma and the restrictions that are in place on its cultivation. The primary aim of this systematic review was to explore the therapeutic value of cannabinoids in the management of chronic pain and thus achieve an improved quality of life for those patients. A systematic review of the literature published over the last two decades was performed using the following databases: PubMed, Cochrane Central Register of Controlled Trials (CENTRAL), Turning research into practice (Trip), and Google Scholar. Studies that were completed and published between January 01, 2000 and August 31, 2024, in English language, were extracted and appraised. A combination of keywords and Boolean operators Cannabis OR Chronic Pain OR End of life OR Pain Management AND Drug therapy was employed for data extraction. The Cochrane risk-of-bias tool for randomized trials (RoB 2) was used for risk-of-bias assessment. The initial search resulted in 125282 articles; 86,781 of the articles were identified as duplicates and were removed from the primary analysis, and 38,501 abstracts were thus screened. Abstracts, case studies, reports, editorials, viewpoints, cross-sectional studies, cohort studies, case-control studies, case series, and letters to the editor/correspondence manuscripts (n =38,492) were furthermore excluded. Nine full-text articles were critically assessed and tested against the inclusion and exclusion criteria, and a further four articles were excluded with a total of five placebo-controlled randomized control studies being ultimately included in the final systematic review. Compared to placebo, cannabinoids provided significant relief from chronic pain (33% vs 15%) as measured by the visual analog scale. The transdermal application of CBD led to a more pronounced reduction in sharp pain, according to the neuropathic pain scale. Minimal to no side effects were recorded, further highlighting the potential benefits of cannabinoids.

Use and impact of clinical pathways across various healthcare settings: A protocol for an umbrella review of global evidence.

AIM: The proposed umbrella review aims to assess the use and impact of clinical pathways on professional practice, patient outcomes, length of hospital stay, hospital costs, patient satisfaction, and hospital staff satisfaction through a synthesis of existing systematic reviews and meta-analyses. METHODS: Following PRIOR guidelines, a systematic search will be conducted in MEDLINE, Epistemonikos, and the Cochrane Library to identify relevant systematic reviews and meta-analyses, from inception till March 2024. Two reviewers will independently screen titles and abstracts, with a third resolving any disagreements. Full-text articles considered potentially relevant will be assessed for eligibility by the same process. The data extraction form will cover information about the review methods, characteristics of the included primary studies, the types of interventions evaluated, and the reported outcomes. This standardized data extraction form will be piloted by the review team on five to ten articles to ensure all relevant information is recorded. The quality of included systematic reviews and meta-analyses will be evaluated using AMSTAR 2. PROSPERO registration number is CRD42024529371. RESULTS: The study will present a narrative synthesis of the findings, addressing the clinical and methodological heterogeneity and assessing the impact of clinical pathways on various healthcare outcomes. CONCLUSION AND IMPLICATIONS: This umbrella review will provide evidence-based insights into the effectiveness, challenges, and best practices of clinical pathways, guiding healthcare decision-making and identifying areas for future research. Results will be disseminated widely to inform policy and improve healthcare service delivery. PATIENT OR PUBLIC CONTRIBUTION: No patient or public contribution, as this paper is a protocol of an umbrella review.

Uptake of health economic evaluations alongside clinical trials in Australia: an observational study.

BACKGROUND: Australia's clinical trials sector is highly productive with continued sector investment needed to enhance research impact. Generating economic evidence alongside trials has the potential to facilitate the implementation of trial results into practice. Ascertaining the use of health economic evaluations alongside clinical trials can assist in determining whether clinical trials fully realize and operationalize their potential to change policy and practice. The aims of this study were to ascertain the uptake of health economic evaluations alongside Australian-led clinical trials and explore associations between uptake and trial characteristics. METHODS: This observational study comprised a descriptive analysis of clinical trials registries, a cross-sectional survey of Australian Clinical Trials Alliance (ACTA) networks, and a subgroup analysis of completed acute care trials. Descriptive analyses of trial registrations were conducted, with logistic regressions used to identify predictors of proposing and subsequently publishing a health economic evaluation alongside acute care trials. RESULTS: Few randomized Australian-led clinical trials (11% of 9251) and ACTA network trials (43% of 227) proposed a health economic evaluation. In the subgroup analysis, 22% of the 324 acute care trials and 53% of the 38 ACTA network acute care trials proposed a health economic evaluation. Acute care trials funded by government bodies were significantly more likely to propose and publish a health economic evaluation than those funded by hospitals, universities, and other funders, after adjusting for phase, registration year, primary sponsor type, and comparator. CONCLUSIONS: Current uptake of health economic evaluations alongside Australian-led clinical trials is low, with uptake higher among the subset of ACTA network trials. This is despite economic evidence playing an increasingly prominent role in health system management, as well as rising health expenditure, limited budgets, and competing demands. There is significant opportunity to embed health economic evaluations alongside clinical trials, particularly phase 3 trials, to increase research outputs and optimize research translation. Investing in clinical trial networks that support funding for a health economist or a health economic evaluation may be an effective strategy to increase the uptake of health economic evaluations alongside trials.

A comparison of drug information question responses by a drug information center and by ChatGPT.

DISCLAIMER: In an effort to expedite the publication of articles, AJHP is posting manuscripts online as soon as possible after acceptance. Accepted manuscripts have been peer-reviewed and copyedited, but are posted online before technical formatting and author proofing. These manuscripts are not the final version of record and will be replaced with the final article (formatted per AJHP style and proofed by the authors) at a later time. PURPOSE: A study was conducted to assess the accuracy and ability of Chat Generative Pre-trained Transformer (ChatGPT) to systematically respond to drug information inquiries relative to responses of a drug information center (DIC). METHODS: Ten drug information questions answered by the DIC in 2022 or 2023 were selected for analysis. Three pharmacists created new ChatGPT accounts and submitted each question to ChatGPT at the same time. Each question was submitted twice to identify consistency in responses. Two days later, the same process was conducted by a fourth pharmacist. Phase 1 of data analysis consisted of a drug information pharmacist assessing all 84 ChatGPT responses for accuracy relative to the DIC responses. In phase 2, 10 ChatGPT responses were selected to be assessed by 3 blinded reviewers. Reviewers utilized an 8-question predetermined rubric to evaluate the ChatGPT and DIC responses. RESULTS: When comparing the ChatGPT responses (n = 84) to the DIC responses, ChatGPT had an overall accuracy rate of 50%. Accuracy across the different question types varied. In regards to the overall blinded score, ChatGPT responses scored higher than the responses by the DIC according to the rubric (overall scores of 67.5% and 55.0%, respectively). The DIC responses scored higher in the categories of references mentioned and references identified. CONCLUSION: Responses generated by ChatGPT have been found to be better than those created by a DIC in clarity and readability; however, the accuracy of ChatGPT responses was lacking. ChatGPT responses to drug information questions would need to be carefully reviewed for accuracy and completeness.

Barriers and facilitators of adherence to clinical practice guidelines in Germany-A systematic review.

RATIONALE: Clinical Practice Guidelines (CPGs) represent evidence-based tools designed to assist healthcare practitioners and patients in decisions in clinical practice. Evidence supports the clinical benefits of adhering to CPGs. However, their successful implementation and adherence in clinical settings often encounter challenges. AIMS AND OBJECTIVES: This systematic review aimed to explore barriers and facilitators influencing adherence to CPGs in Germany. METHOD: The protocol of this study was registered in the Open Science Framework (OSF) registry (DOI: 10.17605/OSF. IO/GMFUB). In November 2022 we searched on PubMed and Embase for primary studies employing qualitative, quantitative and mixed-methods approaches that focus on barriers or facilitators to CPGs adherence in the Germany. Two reviewers independently screened articles, extracted data, and evaluated the quality of the studies. The collected data on barriers and facilitators of CPG adherence were systematically categorized and analyzed using the Theoretical Domains Framework (TDF). RESULTS: A total of 24 studies were included, mainly focusing on adherence to national CPGs. This review introduces a new domain, guideline characteristics, reflecting the need to address barriers and facilitators to CPG development, implementation, dissemination and format, which couldn't be encompassed within the existing 14 domains of TDF framework. Among healthcare professionals, the most frequently reported influencing factors were related to the environmental context and resources (encompassing aspects such as employer support for CPG utilization), the CPG development and dissemination process (including layout, wording, and interactive tools) and beliefs about consequences (such as contradictions with practical experience). Knowledge (knowledge about the content of CPGs, awareness about published CPGs), primarily as a barrier, and reinforcement facilitators (notably financial support), were also frequently reported. CONCLUSION: The findings revealed multilevel factors contributing to CPG adherence, with environmental context and resources emerging as the most frequently reported considerations. This systematic review offer holistic insights into the barriers and facilitators of CPG adherence in Germany. The results contribute to a better understanding of the topic and serve as a resource for developing targeted strategies to enhance CPG adherence and implementation within the German healthcare system.

The Role of Propofol in Alcohol Withdrawal Syndrome: A Systematic Review.

The objective of this review was to evaluate the efficacy and safety of propofol in the treatment of critically ill patients diagnosed with alcohol withdrawal syndrome (AWS). A review was conducted in accordance with the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-Analyses) criteria, and Embase, MEDLINE (PubMed), Cochrane CENTRAL, and Web of Science were queried for results through June 2024. Studies providing efficacy or safety data associated with propofol with a reported diagnosis of AWS in critically ill patients were included. Studies evaluating pediatric patients, those without quantitative and qualitative outcome data, and those not readily translatable to English were excluded. Five retrospective cohort analyses of 218 patients were included in this systematic review. Patients were found to have both significant and non-significant increases in time to resolution of AWS symptoms when treated with propofol versus the AWS standard of care. Adjunct treatment with propofol was generally associated with reductions in total benzodiazepine use and increases in both ICU length of stay and duration of mechanical ventilation. The results of this systematic review provide the evidence necessary to support the use of propofol as an efficacious and safe medication in the management of severe and refractory AWS. Further investigation is required to determine optimal dosing strategies and durations of therapy. The results of this systematic review demonstrate the clinical utility of propofol as part of the management strategy for severe and refractory AWS.

Is an Ambulatory Biofeedback Device More Effective than Instructing Partial Weight-Bearing Using a Bathroom Scale? Results of a Randomized Controlled Trial with Healthy Subjects.

So far, there have been no high-quality studies examining the efficacy of outpatient biofeedback devices in cases of prescribed partial weight-bearing, such as after surgery on the lower limbs. This study aimed to assess whether a biofeedback device is more effective than using a personal scale. Two groups of healthy individuals wearing an insole orthosis were trained to achieve partial loading in a three-point gait within a target zone of 15-30 kg during overground walking and going up and down stairs. The treatment group (20 women and 22 men) received continuous biofeedback, while the control group (26 women and 16 men) received no information. Findings were compared in a randomized controlled trial. Compliance with partial loading without biofeedback was poor; on level ground and stairs, only one in two steps fell within the target area, and overloading occurred on at least one in three steps. The treatment group reduced the percentage of steps taken in the overload zone to ≤8.4% (p < 0.001 across all three courses) and achieved more than two-thirds of their steps within the target zone (p < 0.001 on level ground, p = 0.008 upstairs, and p = 0.028 downstairs). In contrast, the control group did not demonstrate any significant differences in the target zone (p = 0.571 on level ground, p = 0.332 upstairs, and p = 0.392 downstairs). In terms of maintaining partial load, outpatient biofeedback systems outperform bathroom scales.

A Comprehensive Intervention Program for Postoperative Delirium Prevention in Elderly Patients Undergoing Cardiac Surgery.

PURPOSE: To explore the application effect of a comprehensive intervention program for postoperative delirium (POD) prevention. DESIGN: Descriptive and comparative study. METHODS: This study included 82 elderly patients who underwent cardiac surgery as the control group to receive routine perioperative care. Seventy seven elderly patients who underwent cardiac surgery were selected as the observation group and received a comprehensive intervention program for POD prevention. This study further compared the length of stay in the hospital, nutritional status, pain score, and sleep quality between the two groups after intervention. FINDINGS: The postoperative length of stay in the hospital of the observation group was shorter than that of the control group (12.60 ± 2.97 vs 17.30 ± 7.10), and the incidence of POD was lower than that of the latter group (24.68% vs 47.56%, X2 = 8.976, P = .003). The pain scores of the observation group were lower than those of the control group (F = 195.381, P < .001). There was significant difference that the sleep quality score of the observation group was higher than that of the control group (F = 219.20, P < .001). The levels of albumin and hemoglobin in the observation group were higher than those in the control group (54.38 ± 5.87 vs 38.40 ± 3.11; 124.64 ± 13.18 vs 109.00 ± 10.20). The observation group had shorter mechanical ventilation duration, intensive care unit stay, and lower total hospital expenses compared with the control group (P < .05). CONCLUSIONS: The comprehensive intervention program for POD prevention based on evidence-based medicine has a positive effect. In addition, it can also improve patients' pain, sleep quality, and nutritional status.

8. Herpes zoster and post herpetic neuralgia.

INTRODUCTION: Patients suffering from postherpetic neuralgia (PHN) report unilateral chronic pain in one or more dermatomes after an acute herpes zoster (HZ) infection. The incidence of acute HZ ranges between three and five patients per 1000 person-years. In one out of four patients, acute HZ-related pain will transition into PHN. PHN can be very disabling for patients and reduce quality of life. Additionally, the treatment of PHN is characterized by high failure rates. The aim of this review is to give an update on the previous practical guideline published in 2011 and revised in 2015 (published in 2019) and to provide an overview of current interventional treatment options for HZ infection and PHN. METHODS: The literature on the diagnosis and treatment of HZ and PHN was systematically reviewed and summarized. RESULTS: The most important treatment for acute HZ-related pain is antiviral therapy within 72 h of symptom onset. Additional symptomatic treatment options are analgesic drugs according to the WHO pain ladder, tricyclic antidepressants (eg, nortriptyline), and antiepileptic drugs (eg, gabapentin). If pain is not sufficiently reduced, interventional treatment such as an epidural injection with local anesthetics and corticosteroids or pulsed radiofrequency of the dorsal root ganglion (DRG) are options. Treatment for PHN is preferably transdermal capsaicin, lidocaine, or oral drugs such as antidepressants or antiepileptics. CONCLUSIONS: Treatment of acute HZ-related pain especially PHN is challenging. Besides the conventional treatment for PHN, interventional management is considered a new treatment option. PRF of DRG seems to be the most promising interventional management.