Clinical Practice Research Research Articles

Financial management and perioperative leadership in the ambulatory setting journal title: Best practice in clinical research.

A large portion of US healthcare is ambulatory. Strong leadership is vital for the safety and efficiency of perioperative patients in this setting. Good leaders communicate respectfully and openly and ensure effective systems in the delivery of high-level healthcare. In general, to promote patient safety and treatment efficacy, ambulatory care leaders must improve communication. Effective administration is unattainable without leadership and communication in an operating room. When considering outpatient perioperative therapy, it is equally crucial to consider medical costs. Given the unsustainable rate of healthcare spending growth, all attempts to improve our present systems are necessary. Ambulatory care facilities must utilize data regarding resource consumption to be financially viable related to escalating expenses. The present review describes perioperative and financial leadership in the ambulatory setting, effective systems, and relevant clinical strategies.

A national advanced training program for laparoscopic radical gastrectomy has a positive impact on surgical trainees: A before and after study (ATP-LRG-1)

BackgroundDue to the high technical requirements of laparoscopic radical gastrectomy (LRG), establishing an effective training system to promote clinical technology and operation specifications is necessary. We aimed to evaluate the effect of a national advanced training program for LRG (ATP-LRG). Materials and methodsThe contents of the training include the following: 1) detailed technique descriptions; 2) prevention and solving of intraoperative complications; 3) live surgery performance; 4) theory and practice of clinical research; 5) comments on trainees’ videos; and 6) questions, answers, and discussions. This retrospective before and after study surveyed 875 trainees from January 2015 to October 2020. Endpoints were general surgical skills (GSS), laparoscopic gastrectomy acceptance (LGA), and clinical research possibilities (CRP). The analysis took place in December 2021. ResultsThe response rate was 70.5% (617/875). ATP-LRG reportedly had a positive impact on the LRG practice of 99.5% (614/617) of trainees. Their GSS (before vs. after: 16.5 ± 3.7 vs. 20.3 ± 3.1, P < 0.001), LGA (4.2 ± 0.9 vs. 4.6 ± 0.7, P < 0.001), and CRP (2.6 ± 1.2 vs. 3.2 ± 1.1, P < 0.001) significantly improved. The improvement in GSS for those with professional titles of associate chief surgeons and below was significantly higher than that for chief surgeons (4.0 ± 3.0 vs 3.3 ± 2.4, P = 0.017), while those of LGA and CRP were not. The annual number of operations before training was negatively correlated with improvement in GSS (P < 0.001, Pearson's correlation coefficient: 0.14). Multivariate logistic regression showed that those with professional titles of associate chief surgeons and below (odds ratio [OR]: 1.719, 95% confidence interval [CI]: 1.038–2.846, P = 0.035), and with annual number of operations before training being <60, (OR: 5.257, 95% CI: 2.573–10.742, P < 0.001) were most prone to high-GSS improvement. ConclusionThe nationwide ATP-LRG facilitates the improvement of trainees' GSS, LGA, and CRP levels. Surgeons with lower professional titles and fewer performed operations are most likely to improve their GSS through training.

Clinical research capability enhanced for medical undergraduates: an innovative simulation-based clinical research curriculum development

BackgroundClinical research has frequently not been taught in a practical way, often resulting in a very didactic approach rendering it not very accessible for medical undergraduates. Simulation can provide an immersive, interactive, and reflective experience and may be applied to the clinical research curriculum.MethodsA 7-step model, modified from Kern’s six-step approach and Khamis’s stepwise model, was used to develop the curriculum. A questionnaire survey on undergraduates’ attitude towards, knowledge and practice of clinical research and simulation education was conducted to generate a targeted needs assessment. The simulation framework was integrated into the development of educational strategies. Experts were consulted to assess the curriculum prior to implementation.ResultsTalent construction in China needs an innovative capability-enhanced clinical research curriculum. Sixty-six clinical undergraduates in our school completed the survey. 89.39% (59/66) of them hadn’t participated in clinical research, while 93.94% (62/66) would like to conduct clinical trials if possible. 75.76% of respondents didn’t have knowledge of or practical abilities in clinical trials. The mean score for practical ability (2.02 ± 0.92) was lower than that of knowledge (2.20 ± 0.93) (P < 0.01). The dimension of case report form got the lowest score among the five dimensions. Participating in clinical research (P = 0.04) and learning for themselves (P < 0.01) by a few students may have increased the total score. The curriculum was designed to simulate the whole process from protocol writing, registration, ethical approval, implementation, and data analysis to reporting based on one case study, and was divided into two parts to simulate different types of research: randomized controlled trials and observational studies. It was conducted in semesters 5 and 7 respectively, both including 16 sessions. After expert consultation, one session having a 29.01% coefficient of variation was adjusted and replaced. The final simulation class design scenario scripts are provided for reference.ConclusionsThe targeted needs assessment exposed medical undergraduates’ poor knowledge of and abilities in clinical research. This is the first report of a simulation-based clinical research curriculum developed in China, and adds curriculum development and design details to the limited related published studies.

Identifying the role of transient receptor potential channels (TRPs) in kidney renal clear cell carcinoma and their potential therapeutic significances using genomic and transcriptome analyses

Kidney renal clear cell carcinoma (KIRC) is among the major causes of cancer-caused mortality around the world. Transient receptor potential channels (TRPs), due to their role in various human diseases, might become potential drug targets in cancer. The mRNA expression, copy number variation, single-nucleotide variation, prognostic values, drug sensitivity, and pathway regulation of TRPs were studied across cancer types. The ArrayExpress and The Cancer Genome Atlas (TCGA) databases were used to retrieve KIRC samples. Simultaneously, training, internal, and external cohorts were grouped. In KIRC, a prognostic signature with superior survival prediction in contrast with other well-established signatures was created after a stepwise screening of optimized genes linked to TRPs using univariate Cox, weighted gene co-expression network analysis, multivariate Cox, and least absolute shrinkage and selection operator regression analyses. Subsequent to the determination of risk levels, the variations in the expression of immune checkpoint genes, tumor mutation burden, and immune subtypes and response between low-risk and high-risk subgroups were studied using a variety of bioinformatics algorithms, including ESTIMATE, XCELL, EPIC, CIBERSORT-ABS, CIBERSORT, MCPCOUNTER, TIMER, and QUANTISEQ. Gene set enrichment analysis helped in the identification of abnormal pathways across the low- and high-risk subgroups. Besides, high-risk KIRC patients might benefit from ABT888, AZD6244, AZD7762, Bosutinib, Camptothecin, CI1040, JNK inhibitor VIII, KU55933, Lenalidomide, Nilotinib, PLX4720, RO3306, Vinblastine, and ZM.447439; however, low-risk populations might benefit from Bicalutamide, FH535, and OSI906. Finally, calibration curves were used to validate the nomogram with a satisfactory predictive survival probability. In conclusion, this research provides useful insight that can aid and guide clinical practice and scientific research.

Application of the Delphi Method in the Study of Depressive Disorder.

Depressive disorder is a common mental disorder that has a high prevalence and low visiting rate, which caused patients years lived with disability. Due to the complexity of the depressive disorder, the Delphi method is a better choice compared with other commonly used methods, which provides a new perspective for the prevention and treatment of depression. This article will summarize the clinical studies of depressive disorders using the Delphi method from four perspectives, and summarize the advantages and disadvantages of the Delphi method in depressive disorders research, arguing that the Delphi method can cross the gap between clinical research and clinical practice, and is a highly practical part of the research process.

Privacy breaches and electronic communication: Lessons for practitioners and researchers.

In the era of socially distanced clinical andmedical research practices, the use of electronic communication has flourished. The Australian Information Commissioner recently ordered a Victorian general practice to pay $16,400 in compensation following a breach of privacy. This is the largest award of compensation made by the Commissioner in the context of a medical or healthcare privacy matter. The practice had inadvertently sent an email containing sensitive information to an incorrect email address. The email included information concerning the human immunodeficiency virus status ofthe complainants. The aim of this article is to provide anoverview of this important case in Australian information and privacy law, which relates to the operation of an Australian general practice and research activity undertaken within thepractice context. In an era marked by a great increase in the use of electronic communication inthe medical setting, it is essential thatpractices both manage electronic communication well and respond appropriately when an error arises.

Philosophy of Science Can Prevent Manslaughter

In September 2020, the surgeon Paulo Macchiarini, who used stem cell technology to enable the transplants of artificial and donor trachea, was charged with aggravated assault in Sweden. In this comment, we argue that the Ethics Council of the Karolinska Institute should have considered issues from philosophy of science when they were brought to their attention, rather than dismiss them as irrelevant to research ethics. We demonstrate how conceptual issues of a philosophy-of-science-kind about clinical research and medical practice should be integral to research ethics.

Practice and thinking on the traditional Chinese medicine treatment of chronic atrophic gastritis based on pathological evaluation

Chronic atrophic gastritis is a precancerous gastric disease with intestinal epithelial hyperplasia and heterogeneous proliferation based on mucosal atrophy. In recent years, the international guidelines and consensus on the treatment of precancerous gastric disease have been gradually updated, emphasizing the treatment of precancerous gastric disease and lesions based on the pathological changes as the outcome. Chinese medicine is widely used in the clinical treatment of chronic atrophic gastritis, but there are fewer research ideas of Chinese medicine based on the pathological evaluation of the results. In this article, the pathological concepts related to chronic atrophic gastritis and the clinical research ideas and practice strategies of traditional Chinese medicine based on the evaluation of pathological outcomes are compiled.

The quality of clinical practice guidelines for fiberoptic endoscopic evaluation of swallowing: A systematic review

BACKGROUND: Clinical practice guidelines (CPGs) can act as a bridge between clinical research and everyday practice. CPGs have been generated to inform Fiberoptic Endoscopic Evaluation of Swallowing (FEES), but their quality is unclear. OBJECTIVE: This study aims to systematically evaluate the quality of FEES CPGs to identify their suitability for use in clinical practice. METHODS: A systematic review of the literature was conducted. A comprehensive search of four academic databases (Medline, Embase, CINAHL, Web of Science) and other sources was completed. Three independent researchers used the Appraisal of Guidelines for Research and Evaluation-II (AGREE-II) instrument to appraise the quality of included CPGs. CPGs were rated over 23 items across six domains. Intraclass correlation coefficients established agreement across raters. RESULTS: Four FEES CPGs were included. Individual CPG scores ranged from 0% to 89% across AGREE-II domains. Median domain scores were “Scope and Purpose” 66%; “Stakeholder Involvement” 47%; “Rigour of Development” 29%; “Clarity of Presentation” 60%; “Applicability” 13% and “Editorial Independence” 0%. None of the CPGs included sufficient detail regarding their development methodology and supporting evidence. No CPG was recommended to guide practice in their current state. Only 1 CPG was recommended for use, upon appropriate modifications. CONCLUSION: CPGs are highly influential tools that play a vital role in guiding clinical practice. Study findings highlight a scarcity of high-quality FEES CPGs to inform dysphagia practice. Superior FEES CPGs are required to ensure individuals with dysphagia are benefiting from high-quality research emerging internationally.

CDC7 as a novel biomarker and druggable target in cancer

Due to the bottlenecks encountered in traditional treatment for tumor, more effective drug targets need to bedeveloped. Cell division cycle 7 kinase plays an important role in DNA replication, DNA repair and recombination signaling pathways. In this review, we first describe recent studies on the role of CDC7 in DNA replication in normal human tissues, and then we integrate new evidence focusing on the important role of CDC7 in replication stress tolerance of tumor cells and its impact on the prognosis of clinical oncology patients. Finally, we comb through the CDC7 inhibitors identified in recent studies as a reference for further research in clinical practice.

Huntington's Disease Regulatory Science Consortium: Accelerating Medical Product Development.

Huntington's disease (HD) is a devastating neurodegenerative disorder that urgently needs disease-modifying therapeutics. To this end, collaboration to standardize clinical research practices in the field and drive progress in addressing drug development challenges is paramount. At a meeting in 2017 organized by CHDI Foundation and the Critical Path Institute, stakeholders across the pharmaceutical industry, academia, regulatory agencies, and patient advocacy groups discussed the need for and potential impact of a consortium dedicated to HD regulatory science. Consequently, the Huntington's Disease Regulatory Science Consortium (HD-RSC) was formed, a precompetitive consortium that is dedicated to building a regulatory strategy to expedite the approval of HD therapeutics.

Development of Nursing Research–Directions and Best Practices in the USA and Europe: A Narrative Review

Summary Nursing research is a relatively new area of professional development that began firstly in the USA and made significant progress during the second half of the 19th century. Nursing research has made significant progress in European countries, mainly developed countries. This article aimed to review publications describing the evolution of nursing research, the directions of development, and best practices in the USA and Europe. Different databases were searched according to selected criteria, and a narrative literature review was conducted. Forty-two articles from the USA and Europe were identified and included as the most appropriate in the analysis, published in 22 journals. During the analysis, five basic directions of developing nursing research were identified - nursing research education, organizational structures for nursing research and collaboration with clinical professionals, research dissemination and journals, trends and priorities, and funding nursing research. To increase research capacity and respond to the growing research culture and the requirements of the scientific community, nursing research education is needed at every educational level. Establishing organizational structures has proved the importance of supporting and encouraging nurses to participate in and conduct studies. Funding research in teams is more likely to occur at any organization or centеr than looking for funding sources from individuals. Encouraging nurses and midwives to conduct research in clinical practice and publish results from scientific studies will help achieve sustainable implementation of evidence-based practice.

Clinical Translation of Microbiome Research in Alopecia Areata: A New Perspective?

The continuous research advances in the microbiome field is changing clinicians’ points of view about the involvement of the microbiome in human health and disease, including autoimmune diseases such as alopecia areata (AA). Both gut and cutaneous dysbiosis have been considered to play roles in alopecia areata. A new approach is currently possible owing also to the use of omic techniques for studying the role of the microbiome in the disease by the deep understanding of microorganisms involved in the dysbiosis as well as of the pathways involved. These findings suggest the possibility to adopt a topical approach using either cosmetics or medical devices, to modulate or control, for example, the growth of overexpressed species using specific bacteriocins or postbiotics or with pH control. This will favour at the same time the growth of beneficial bacteria which, in turn, can impact positively both the structure of the scalp ecosystem on the host’s response to internal and external offenders. This approach, together with a “systemic” one, via oral supplementation, diet, or faecal transplantation, makes a reliable translation of microbiome research in clinical practice and should be taken into consideration every time alopecia areata is considered by a clinician.

Applications of Body Imaging Techniques in Clinical Practice and Biomedical Research: An Overview

Background: Applications of imaging technology modalities have accumulated evidence that individual components of body composition (BC) have significant influences on chronic disease onset, disease progression, treatment responses and health outcomes. Objective: To analyse the currently available body imaging techniques and their applications in clinical practice and medical research. Methods: To review the various body imaging techniques and their applications in clinical practice and medical research, Medline, PubMed, Google scholar, ResearchGate and other databases were searched. Furthermore, references of selected studies and documents available in different libraries were also searched. Findings: Imaging modalities have provided a systematic method for differentiating phenotypes of BC that diverge from normal, i.e. having low bone mass (osteopenia/osteoporosis), low muscle mass (sarcopenia), high fat mass (obesity), or high fat with low muscle mass (sarcopenic obesity). Tremendous advances were made over the past decades in the sensitivity and quality of imaging techniques such as Duel-Energy X-Ray Absorptiometry (DXA), Computed Axial Tomography (CT), Ultrasound (US), Magnetic Resonance Imaging (MRI), Magnetic Resonance Spectroscopy (MRS), Positron Emission Tomography (PET), Bioelectrical Impedance Analysis (BIA) etc. These imaging techniques have been useful to differentiate layers or depots within tissues and cells enhancing our understanding of distinct mechanistic, metabolic and functional roles of BC within human phenotypes. Conclusion: In the present overview, we focused on DXA, CT and US for the use in clinical practice and biomedical research relevant to future investigation of human BC and how they may be applied to remedy the pandemic of obesity, diabetes and metabolic syndrome. Bangladesh Med Res Counc Bull 2021; 47(2): 103-109

SemClinBr - a multi-institutional and multi-specialty semantically annotated corpus for Portuguese clinical NLP tasks

BackgroundThe high volume of research focusing on extracting patient information from electronic health records (EHRs) has led to an increase in the demand for annotated corpora, which are a precious resource for both the development and evaluation of natural language processing (NLP) algorithms. The absence of a multipurpose clinical corpus outside the scope of the English language, especially in Brazilian Portuguese, is glaring and severely impacts scientific progress in the biomedical NLP field.MethodsIn this study, a semantically annotated corpus was developed using clinical text from multiple medical specialties, document types, and institutions. In addition, we present, (1) a survey listing common aspects, differences, and lessons learned from previous research, (2) a fine-grained annotation schema that can be replicated to guide other annotation initiatives, (3) a web-based annotation tool focusing on an annotation suggestion feature, and (4) both intrinsic and extrinsic evaluation of the annotations.ResultsThis study resulted in SemClinBr, a corpus that has 1000 clinical notes, labeled with 65,117 entities and 11,263 relations. In addition, both negation cues and medical abbreviation dictionaries were generated from the annotations. The average annotator agreement score varied from 0.71 (applying strict match) to 0.92 (considering a relaxed match) while accepting partial overlaps and hierarchically related semantic types. The extrinsic evaluation, when applying the corpus to two downstream NLP tasks, demonstrated the reliability and usefulness of annotations, with the systems achieving results that were consistent with the agreement scores.ConclusionThe SemClinBr corpus and other resources produced in this work can support clinical NLP studies, providing a common development and evaluation resource for the research community, boosting the utilization of EHRs in both clinical practice and biomedical research. To the best of our knowledge, SemClinBr is the first available Portuguese clinical corpus.

GOOD CLINICAL PRACTICE IN PHARMACOVIGILANCE

Clinical research is a mechanism or a process that provides convincing evidence that the new treatments or therapies suggested are safe and effective. The ultimate aim of clinical research is the identification and discovery of contemporary diagnostic methods as well as the establishment of advanced standards of medicine. Good Clinical Practice (GCP) is an ethical and scientific quality standard for designs, operations and recordings involving the participation of human subjects. Accompanying the Guidelines pledges to the public that the ethics, integrity and welfare of humans participating in the trials are protected. India has experienced distinct opportunities for clinical trials for clinical trials compared to ethical patients, major medical institutions with fewer and more equipped investigators and fewer patient voices than regulated countries, with larger patient counts. However, our Indian guidelines were needed to ensure a uniform standard of clinical research across the country and to provide data for registration for new drugs before use in the human population in India. Junctions guidelines were developed by a complete committee set up by CDSCO with clinical experts. This article explains the importance of good clinical practice from an Indian clinical research perspective, while defining and outlining the goals and objectives of the GCP. It addresses the historical events that led to the emergence of good clinical practices and examines the current scenario with respect to the application of GCPs in clinical trials in India. Finally, the article addresses the challenges to maintaining a best and competitive system and will suggest a way forward to increase the credibility and efficiency of good clinical practice in clinical research.

Telling my life: Narratives of coming out in LGB people between certainty/uncertainty and revelation/concealment

Introduction: The coming out (CO) process frequently entails moments of questioning and challenge, as well as strength and resilience. The aim of the present study was to investigate the CO process and identity development of lesbian, gay, and bisexual (LGB) people through their own life narratives. Method: Adopting a social-constructionist perspective, we administered the Life Story Interview (LSI) from the qualitative protocol of the Generations Study. In total, 64 LGB people aged 23–75 participated in the study. Interviews were analyzed using the semiotic enunciative square technique, based on discourse analysis and mitigation markers. Result: The present study highlighted how participants’ life stories were characterized by fluctuating moments lived between certainty/uncertainty, revelation/concealment, denial/non-denial (i.e., “blocked identity” vs. assertive-agent identities), and acceptance/non-acceptance (i.e., aware vs. fearful identities). Conclusion: The perspective of social constructionism was shown to be appropriate for investigating the CO process. Implications for clinical practice and future research are discussed.

Effects of pre-pregnancy BMI and gestational weight gain on adverse pregnancy outcomes and complications of GDM

To investigate the effects of pre-pregnancy BMI and gestational weight gain on adverse pregnancy outcomes and complications of gestational diabetes mellitus. 3966 pregnant women were enrolled in this study. Multivariate logistic regression analysis was conducted to estimate the relative risk between pre-pregnancy BMI, gestational weight gain, and adverse pregnancy outcome. Pre-pregnancy BMI was found to be a risk factor for preeclampsia (OR = 1.159), gestational diabetes mellitus (OR = 1.191), gestational hypertension (OR = 1.221), and macrosomia (OR = 1.165). Gestational weight gain was a risk factor for preeclampsia (OR = 1.783), placental abruption (OR = 2.209), and macrosomia (OR = 1.506). Total weight gain during pregnancy cannot be used as a predictor of GDM. Pre-pregnancy BMI is a risk factor for gestational diabetes mellitus complicated with preeclampsia, preterm delivery, gestational hypertension, and macrosomia. Impact statement What is already known on this subject? Obesity during pregnancy includes pre-pregnancy obesity and excessive weight gain during pregnancy. Obese pregnant women have a higher risk of pregnancy complications. What do the results of this study add? We focus on the effects of pre-pregnancy BMI on pregnancy outcomes, classified by Asian criteria. Our findings suggest for the first time that excessive weight gain during pregnancy is a risk factor for placental abruption and we specifically point out that total weight gain during pregnancy cannot be used as a predictor of GDM. What are the implications of these findings for clinical practice and/or further research? This study is helpful to monitor the risk of adverse pregnancy outcomes in the Asian population and suggest the risk of pregnancy complications, such as gestational diabetes mellitus and placental abruption.

CARE guidelines for case reports: explanation and elaboration document. Translation into Russian

BACKGROUND: Well-written and transparent case reports (1) reveal early signals of potential benefits, harms, and information on the use of resources; (2) provide information for clinical research and clinical practice guidelines, and (3) inform medical education. High-quality case reports are more likely when authors follow reporting guidelines. During 20112012, a group of clinicians, researchers, and journal editors developed recommendations for the accurate reporting of information in case reports that resulted in the CARE (CAse REport) Statement and Checklist. They were presented at the 2013 International Congress on Peer Review and Biomedical Publication, have been endorsed by multiple medical journals, and translated into nine languages.&#x0D; OBJECTIVES: This explanation and elaboration document has the objective to increase the use and dissemination of the CARE Checklist in writing and publishing case reports.&#x0D; ARTICLE DESIGN AND SETTING: Each item from the CARE Checklist is explained and accompanied by published examples. The explanations and examples in this document are designed to support the writing of high-quality case reports by authors and their critical appraisal by editors, peer reviewers, and readers.&#x0D; RESULTS AND CONCLUSION: This article and the 2013 CARE Statement and Checklist, available from the CARE website [www.care-statement.org] and the EQUATOR Network [www.equator-network.org], are resources for improving the completeness and transparency of case reports.&#x0D; SOURCE: This article is a translation of the original paper CARE guidelines for case reports: explanation and elaboration document in the Journal of Clinical Epidemiology (doi: 10.1016/j.jclinepi.2017.04.026), prepared under the permission of the copyright holder (Elsevier Inc.), with supervision from the Scientific Editor by Professor E.G. Starostina, MD, PhD (translator) (Moscow, Russia).

The real practice of clinical and economic research of drugs included in the Federal Program of High-Cost Nosologies

Objective: to assess the compliance of the actual practice of conducting clinical and economic research with the requirements applicable in the Russian Federation (RF) when including drugs in the Federal Program of High-Cost Nosologies (HCN).Material and methods. In the CyberLeninka and eLibrary databases, a search was made for clinical and economic studies of medicines included in the HCN list published in the RF in the period from 2011 to June 2021.Results. Information was obtained on 23 published clinical and economic studies of the effectiveness of drugs, which is less than 30% of all drugs included in the HCN program during the specified period. More than half of the studies of chronic disabling diseases had a modeling horizon of 1 year. The sensitivity analysis of the results in over 1/3 of cases considered only the deviation of the price of the strategies under consideration, and in a quarter of cases it was not carried out at all. Only 4 studies evaluated the increase in quality-adjusted life year, although, for chronic disabling diseases, quality of life is one of the key performance indicators.Conclusion. In the RF, less than 30% of the results of pharmacoeconomical studies of drugs included in the HCN Program are published, which does not allow to make adequate evaluation of pharmacoeconomical approaches to its formation. To analyze the effectiveness of the tools used in assessing the economic efficiency of expensive medical technologies, a further retrospective research of the studies conducted in the RF is required.