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BACKGROUND@#This study aimed to develop a comprehensive instrument for evaluating and ranking clinical practice guidelines, named Scientific, Transparent and Applicable Rankings tool (STAR), and test its reliability, validity, and usability.@*METHODS@#This study set up a multidisciplinary working group including guideline methodologists, statisticians, journal editors, clinicians, and other experts. Scoping review, Delphi methods, and hierarchical analysis were used to develop the STAR tool. We evaluated the instrument's intrinsic and interrater reliability, content and criterion validity, and usability.@*RESULTS@#STAR contained 39 items grouped into 11 domains. The mean intrinsic reliability of the domains, indicated by Cronbach's α coefficient, was 0.588 (95% confidence interval [CI]: 0.414, 0.762). Interrater reliability as assessed with Cohen's kappa coefficient was 0.774 (95% CI: 0.740, 0.807) for methodological evaluators and 0.618 (95% CI: 0.587, 0.648) for clinical evaluators. The overall content validity index was 0.905. Pearson's r correlation for criterion validity was 0.885 (95% CI: 0.804, 0.932). The mean usability score of the items was 4.6 and the median time spent to evaluate each guideline was 20 min.@*CONCLUSION@#The instrument performed well in terms of reliability, validity, and efficiency, and can be used for comprehensively evaluating and ranking guidelines.
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Humanos , Reproducibilidad de los Resultados , Encuestas y Cuestionarios , Guías de Práctica Clínica como AsuntoRESUMEN
Objective:To study the clinical effect of balloon compression closure kyphoplasty in the treatment of fresh single-segment vertebral compression fracture.Methods:A retrospective study was used to analyze the clinical data of 80 patients with osteoporotic vertebral compression fracture (OVCF) admitted to Gansu Provincial Hospital of Traditional Chinese Medicine from June 2019 to June 2021. They were divided into two groups according to the surgical methods: the simple percutaneous kyphoplasty (PKP) group and the percutaneous kyphoplasty compression group, with 40 patients in each group. The PKP group was routinely treated with PKP, and the PKP compression group was treated with balloon compression occlusion technology on the basis of the PKP group. The amount of bone cement injected, the leakage of bone cement, the height of the anterior edge of the injured vertebra, the Cobb angle of kyphosis, the visual analogue score (VAS) and the Oswestry dysfunction index (ODI) were compared between the two groups. The measurement data conforming to the normal distribution were expressed as ( ± s), and the comparison between the two groups was conducted by t-test; The counting data were expressed by n(%) and the comparison between the two groups adopts Chi-square or Fisher exact probability. Results:The amount of bone cement injected and the leakage rate of bone cement in the PKP compression group were significantly higher than those in the simple PKP group ( P<0.05). The height of the anterior edge of the injured vertebra in the two groups was significantly higher than that before the operation on the first day and three months after the operation ( P<0.05). The Cobb angle, VAS score and ODI index of the injured vertebra in the two groups were significantly lower than that before the operation on the first day and three months after the operation ( P<0.05). The height of the anterior edge of the injured vertebra in the PKP compression group was significantly higher than that in the PKP group ( P<0.05). The Cobb angle of kyphosis in the PKP compression group was significantly lower than that in the simple PKP group at 1 day and 3 months after operation ( P<0.05). There was no significant difference in VAS score between PKP compression group and PKP group on 1 day after operation ( P>0.05), and compared with PKP group on 3 months after operation ( P<0.05). There was no significant difference in the ODI index between the PKP compression group and the two groups 1 day and 3 months after PKP ( P>0.05). Conclusion:Balloon compression closure technology can significantly reduce the leakage of bone cement in PKP and increase the amount of bone cement injected, which is beneficial to reduce the pain of vertebral body and improve the function of OVCF patients, and can improve the clinical treatment effect, which is worth promoting.
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Objective:To evaluate the reporting quality of diagnostic radiological imaging case reports published in Chinese science citation database (CSCD) imaging journals.Methods:This study was a cross-sectional survey. We searched CSCD to include imaging journals from 2021 to 2022, from which we retrieved diagnostic radiological imaging case reports published in 2020, and evaluated their reporting quality using case reports (CARE) reporting criteria.Results:A total of five imaging CSCD journals were searched, with 161 final diagnostic imaging case reports included. The median and interquartile range reporting rate of the included studies was 33.5% (7.5%, 93.3%), and patient perspective and informed consent were not reported in all studies. Items with reporting rates below 10% included 3a (abstract-introduction), 3c (abstract-diagnoses, therapeutic interventions, and outcomes), 8b (diagnostic challenges), and 8d (prognosis where applicable), with reporting rates of 2.5% (4/161), 0.6% (1/161), 0.6% (1/161), and 4.3% (7/161), respectively. Reporting rates for items between 10% and 50% included 3b (abstract-main symptoms and/or important clinical findings), 4 (introduction), 5c (medical, family, and psycho-social history), 7 (timeline), 10 (follow-up and outcomes), and 11a (a scientific discussion of the strengths and limitations), with reporting rates of 16.8% (27/161), 30.4% (49/161), 34.2% (55/161), 24.8% (40/161), 32.9% (53/161), and 31.7% (51/161), respectively; The reporting rates for item 1 (title), item 2 (keywords), item 5a (identified patient specific information), item 5b (primary concerns and symptoms of the patient), item 8a (diagnostic testing), and item 11c (the scientific rationale for any conclusions) were all over 90%. Moreover, the number of authors as well as the number of disciplines were not associated with the quality of diagnostic imaging case reports.Conclusions:The overall adherence to CARE items in radiographic diagnostic case reports published in the CSCD imaging journals is low. Editors of the imaging journals, radiologists and the researchers of the reporting standard should emphasize the guidelines for drafting case reports and improve the quality of reporting of case reports.
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This article introduces two methodological articles published by the American College of Obstetricians and Gynecologists in September 2021 on their development of clinical practice guidelines and clinical expert consensus, focusing on the composition of the guidelines committee, declaration and management of conflicts of interest, and the detailed development process. On this basis, reflections and suggestions for the development of guidelines and consensus in obstetrics and gynecology in China are presented from the perspective of developing a handbook for standardized guideline development, registration and reporting of guidelines, use of available evidence, management of conflicts of interest, and regular evaluations of relevant published guidelines.
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Objective:To investigate the orthopedists' cognition on Chinese Osteoarthritis Guideline (2018 Edition).Methods:Questionnaire about Chinese Osteoarthritis Guideline (2018 Edition) was developed and sent to orthopedists via an invitation link to fill out after authorization from Chinese Osteoarthritis Association. The content of the questionnaire included the basic personal information of the physician, the awareness rate of the guidelines, the evaluation of the guidelines, and its application effects. The survey duration was from September 2019 to December 2019. Multivariate logistic regression and linear regression analysis were performed for the guideline awareness rate and comprehensive score, respectively.Results:A total of 628 physicians completed the questionnaire, of which 623 of 628 (99.2%) were available. About 72.4% of the orthopedists knew the guideline. The awareness rate was statistically related to the education of the physicians ( P<0.05). Respondents' overall score for the guideline was 8.39 with methodological score 8.28. A total of 41.2% of orthopedists thought that the guideline was very good compared with the European and American guidelines, and the clinical problem coverage rate was 78.6%. There is a statistically significant difference in the appraisal of the recommendations ( χ2=138.9, P<0.05) . More than 40% of orthopedists believed that the guidelines were of great help to orthopedists and patients, and that the guide could be promoted to the primary hospitals. Conclusion:After one year publication of Chinese Osteoarthritis Guideline (2018 Edition), most orthopedists have understood the present guideline and applied recommendations in clinical practice. However, the guideline need to be further promoted and disseminated in the future.
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At present, several clinical practice guidelines for osteoarthritis have been developed. Although contradictions about some recommendations are still in dispute, large number of clinical practice guidelines recommended core treatments, namely education, weight loss and exercise therapy. Thus, the diagnosis and treatment of primary osteoarthritis should focus on the above three treatments. However, we have to develop the clinical practice guidelines for osteoarthritis in primary hospital, based on the characteristics of osteoarthritis in China, the burden of disease, the health literacy of patients and the clinical decision-making of diagnosis and treatment of primary osteoarthritis in primary medical care.We suggest to formulate guidelines for the diagnosis and treatment of osteoarthritis in primary medical care to regulate primary interventions.
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Objective To analyze systematically the existing classification criteria and assessment tools for osteoarthritis (OA).Methods Comprehensively searched and screened the available classification criteria and assessment tools reported in OA guidelines,textbooks,including secondary and original researchs.We collected and summarized the extracted data with the methods of scoping review and also used Excel software for qualitative analysis.Results A total of 63 OA guidelines,1 textbook,239 secondary or original researches,160 supplementary records were retrieved.The 5 classification criteria and 15 systematic reviews of assessment tools (855 assessment tools) were finally included.Conclusion The existing classification criteria lack a rigorous and transparent development process,and they are also too complicate to guide clinical treatment.We suggest that the development and improvement of OA classification criteria should be linked with the streamlined assessment tools,and conduct trials to test in clinical practice.
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Objective To evaluate the evidence and recommendations of the relevant clinical practice guidelines for the prevention and treatment of stroke published in the last five years. Methods The stroke and guideline-related key words and free words domestic computer retrieval platforms(China biomedical literature database,CNKI,and Yimaitong etc.),as well as foreign platforms(PubMed,NGC,GIN,etc.) were retrieved.The retrieval time limit ranged from January 2012 to May 2017.Appraisal of Guidelines for Research and Evaluation Ⅱ(AGREE Ⅱ)was used to assess the quality of the guidelines. Results A total of 9 490 documents were retrieved preliminarily and finally 16 articles were included. The average scoring rates of the 16 guidelines in the 6 fields of AGREE Ⅱ,including the scope and purpose,participants,rigor of the formulation,clarity of expression,applicability,and independence of the editors were 66.3%, 27.4%,23.0%,53.9%,18.8%,and 0%,respectively.The different guidelines all recommend that internal endarterectomy or carotid balloon dilatation and carotid artery stenting are used to extracranial carotid stenosis,while the treatment of vertebral artery stenting is recommended for extracranial vertebral artery stenosis.However,the intravascular interventional therapy is not recommended for intracranial arterial stenosis.The perioperative period of ischemic stroke intravascular intervention need to pay attention to the application of anti-platelet aggregation,anticoagulation,blood pressure,blood glucose,blood lipid management,and postoperative monitoring. For postoperative stent restenosis,especially after vertebral artery stenting,the guidelines recommend using drug-eluting stents,however,the dosage of heparin in intraoperative anticoagulation is still controversial.The intracranial aneurysm guidelines are more recommended for interventional therapy.The cerebral hemorrhage in different regions is recommended for different surgical procedures. Conclusions The guidelines in this field can reflect the key problems in clinical practice and keep up with the international concept.However,the quality of the methodology of the guidelines development needs to be improved. Some of them need to be updated and the recommendations should refer more evidence of the Chinese population.
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Objective: Through analyzing development statue of integrative coronary heart disease clinical practice guidelines, we aim to provide a reference baseline for the future study. Methods: Databases including CBM, CNKI, WanFang, VIP were searched for published integrative coronary heart disease clinical practices. The website medlive.cn was also used as supplementary. The reporting tool for clinical practice guidelines RIGHT statement was used to evaluate the reporting quality. Results: A total of nine relevant clinical practice guidelines or experts consensuses were included, covering five integrative treatment therapy guidelines of PCI or CABG perioperative period, three myocardial infarction guidelines and one atherosclerosis guideline. Experts consensus methods were adopted in seven guidelines, the remining two guidelines used the evidence-based guidelines development methods. The evaluation of RIGHT statements showed that most guidelines reported complete information in"Basic information"and"Background"domain, however, they usually failed to provide enough description in"Evidence", "Recommendations", "Review and quality assurance", "Funding and declaration and management of interests"and"Other information"parts. Conclusion: Although some achievements have been reached in the development of integrative coronary heart disease clinical practice guidelines, the development methods and quality of reporting still needs further improvements. Researchers should explore more specific Chinese medicine guideline development methods and tools in the future.
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OBJECTIVE:To explore an effective method to formulate management-related strategies for off-lable use of drugs by the evidence-based medicine. METHODS:The process of guideline formulation included seven procedures,i.g. establishment ofguideliesformulation workgroup;investigation and selection of the status quo on off-label drug use;identification of the clinical problems;retrieval and evaluation and comprehensing of evidence;applification of GRADE in evidence quality grading;formation of the recommendations consensus;peer review and result publication. And eventually guidelines were formed based on the steps. This study took off-label use of rheumatoid immunoprotective subjects as a case to explore. RESULTS & CONCLUSIONS:Based on the evidence evaluation system and above 7 steps,the methods and process of guideline formulation on off-label use of rheuma-toid immunoprotective subjects that integrated administration,law,clinical medicine,pharmacy subjects were made .The process of guideline formulation fully reflects multidisciplinary characteristics of the workgroup,the advanced nature of the process,the comprehensiveness of evidence ,the rigor of evidence quality grading,and the normalization of consensus. It provides reference in methodology for establishing a comprehensive evidence-based evaluation and management system of off-label use of drugs for all clinical specialist disease. Therefore,this scientific research results may promote the standardization and legalization of the off-label use of drugs management in China.
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Objective To examine the iron content and the expression of hepcidin in early period after subarach-noid hemorrhage (SAH) in rats, and to explore the role of hepcidin in dysregulation of brain iron metabolism after SAH. Methods Totally 90 adult male SD rats were randomly divided into two groups:the sham-operation group and SAH group. The SAH model was established by single blood injection to prechiasmatic cistern. Immunohistochemical and Western Blotting were used to examine the expression of hepcidin at 12, 24, 48 and 72h after SAH. Meanwhile, Atomic Absorption Spectrometer was used to detect the iron content. Results Immunochemistry showed that hepcidin expression in rats in SAH group began to rise at 12 h(0.30±0.06)and gradually increased over time until 72 h(0.56±0.07)compared with the sham group(0.19±0.05). The expression of hepcidin was significantly higher in SAH group than in the sham group(F=31.911, P<0.05). Western blot showed that hepcidin expression in rats in SAH group began to rise at 12h(0.481±0.065) and gradually increased over time until 72h(1.627±0.143)Compared with the sham group(0.238±0.047). The expression of hepcidin was significantly higher in SAH group than in the sham group after SAH(F=147.314,P<0.05). Iron content in SAH group began to rise at 12h after SAH(58.50±9.19)and gradually increased until 72 h(99.34±7.68). The iron con-tents in SAH group were higher at every time points than those in sham group(43.51±4.59)(F=28.799,P﹤0.05). The ex-pression of hepcidin was correlated with the iron content in SAH group(r=0.914,P﹤0.01). Conclusion The increase in iron content following SAH is associated with the increased hepcidin expression.