Severe trauma is a challenging medical problem. Uncontrolled post-traumatic hemorrhage and traumatic coagulation dysfunction are closely related to the prognosis of these patients. In May 2019, the pan-European, multidisciplinary Task Force for Advanced Bleeding Care in Trauma published the fifth edition of the European guideline on management of major bleeding and coagulopathy following trauma. To assist Chinese in better understanding of the latest developments, this paper translated the main treatment recommendations in the guideline and interpreted the updated content from the fourth edition.
Objective To analyze the methodological quality of clinical practice guideline mentioned “evidence-based” in China. Methods We selected clinical guidelines developed based on evidence issued by the Chinese Medical Association in 2010-2012, and meanwhile, we conducted additional search for guidelines on clinical major diseases. Then, we selected literature according to the inclusion and exclusion criteria and evaluated the included guidelines according to 8 items relevant to methodological rigor which were selected from the Appraisal of Guidelines for Research and Evaluation (AGREE II). If the guidelines comply with the item, we recorded 1 point, otherwise 0 point. Results a) Among twenty-two included guidelines, 13 were originated and 9 were updated once every 3 to 5 years. b) Diseases covered stroke, diabetes, chronic hepatitis B, hypertension, pediatric nutrition, etc. c) The number of guideline references were 10 to 218, of which, nine guidelines cited 24 Cochrane systematic reviews (CDSRs), accounted for 2.62% (24/916). Among them, the acute ischemic stroke guideline cited the most (7 CDSRs). d) The number of experts involved in guidelines development was 2 to 95 and guidelines pages were 4 to 150. e) The guidelines’ quality generally scored 4 to 7, most of which described the process of guidelines development. The grades of recommendation were consistent with the levels of evidence. But most of the included guidelines did not clearly described literature research methods, peer reviewer, and update procedures. Conclusion There is a growing trend that clinical guidelines are developed based on evidence in China. However, the quality of reporting and the methodological rigor of guidelines need further improvement. The citation rates of Cochrane systematic reviews in these guidelines were relatively low. We suggest that guideline recommendations should be consistent with the levels of evidence and adapt to local conditions, and relevant support policies for guideline implementation in practice. In future, attention should be paid to the aspects of guideline development methods, reporting standard, guideline accessibility, and standard training for relevant personnel.
ObjectivesTo evaluate the methodological and reporting quality of clinical guidelines and consensus for esophageal cancer.MethodsDatabases including PubMed, EMbase, Web of Science, CBM, WanFang Data and CNKI were electronically searched and major guideline websites such as GIN, NICE, NGC and Yimaitong were also searched to collect guidelines and consensus for esophageal cancer from inception to August 2018. Two reviewers independently screened the literatures and extracted data according to the inclusion and exclusion criteria and then evaluated the quality of the included guidelines using the AGREE II and RIGHT instruments.ResultsA total of 26 esophageal cancer guidelines and consensus were included. The mean scores for each domain of AGREE II was 49.63% for scope and purpose, 25.16% for stakeholder involvement, 23.42% for rigor of development, 49.25% for clarity of presentation, 16.91% for applicability, and 21.07% for editorial independence. The item with the highest reporting rate among the RIGHT evaluation items was 5 (84.62%), followed by 1a (80.77%), 1c (65.38%), 13a (65.38%), and 4 (61.54%), and the remaining items were all reported below 50%. Results of subgroup analysis showed that the guidelines and consensus developed based on the evidence-based medicine method had higher average scores in the six domains of AGREE II and the RIGHT score than the guidelines and consensus developed based on expert opinions or reviews. The foreign guidelines and consensus had higher average scores in the three domains of AGREE II (formulation rigor, clarity, editorial independence) and the RIGHT score than the domestic guidelines.ConclusionsThe methodological and reporting quality of the guidelines and consensus on esophageal cancer is low, with the guidelines and consensus in China even lower, requiring further improvement. It is suggested that the guideline developers should refer to the standards such as AGREE II and RIGHT to develop high-quality guidelines and promote their application, so as to better guide the standardized diagnosis and treatment of esophageal cancer.
Early and mid-stage esophageal cancer can achieve a particular effect through surgeries or comprehensive treatment based on surgery. Once the esophageal cancer progresses to the advanced stage, it is still lack of effective remedy for the disease, and the patient's prognosis is poor. Immunotherapy has developed rapidly in recent years, bringing dawn to patients with advanced esophageal cancer. On July 31, 2019, the US Food and Drug Administration (FDA) approved KEYTRUDA (Merck) for the treatment of esophageal squamous cell carcinoma, and it became the first milestone drug for esophageal squamous cell carcinoma. In the paper, we will review the progress of immunotherapy in the treatment of advanced esophageal cancer on the basis of current clinical researches, which might provide ideas for further studies in the immunotherapy for esophageal cancer.
ObjectiveTo evaluate the quality of traditional Chinese medicine (TCM) guidelines, so as to provide evidence for developing similar guidelines. MethodsWe systematically searched TCM guidelines published in domestic medical journals from WanFang Data, VIP, CNKI and CBM. We also searched Google, Amazon.cn and dangdang.com by hand in order to obtain TCM guidelines published in monographs. And we used AGREE II instrument to assess the methodological quality of included guidelines. ResultsA total of 115 guidelines (87 published in domestic medical journals and 28 published in monographs) were included. Scaled domain percentages from highest to lowest were:scope and purpose (41%), stakeholder involvement (28%), clarity of presentation (33%), rigour of development (20%), editorial independence (9%) and applicability (7%). ConclusionThere is still a large gap about methodological quality between TCM guidelines and international guidelines. So the guideline developers should systematically search, evaluate and synthesize the evidence based on structured problems. At the same time, they also need to consider the costs of recommendations, the implementation environment and the patients' preference and values. On this basis, the developer could further increase the transparency and independence during developing TCM guidelines.
ObjectivesTo systematically review the necessary factors of questionnaires design on patients' values and preferences in order to provide information on the most appropriate questionnaires when developing clinical practice guidelines.MethodsA systematic literature search of PubMed, EMbase, The Cochrane Library, CBM, CNKI and WanFang Data databases was performed to identify studies on questionnaires evaluating patient values and preferences. The authors included the articles that used fully structured questionnaires or scales with standardized questions and answer options. We assessed the questionnaires' construction with psychometric methodology and summarized the necessary factors on patients' preferences and values into the domains and items.ResultsTwenty articles were eventually included. Five out of 20 studies (25%, 5/20) described the process of item generation while merely one questionnaire (5%, 1/20) mentioned pilot testing. Regarding validity, there were 6 questionnaires (30%, 6/20) that assessed validity. For acceptability, the time taken to complete the questionnaires range from 10 to 30 minutes and only 6 studies reported response rates. The results showed that the factors affecting the design of questionnaires on patients' values and preference were related to the effectiveness, safety, prognostic factors and others. The main factors were the effects, side effects and risk of complications, risk of relapse and the cost of treatments.ConclusionsOnly a few studies have developed questionnaires with rigorous psychometric methods to measure patients' preference and values. There is still no valid or reliable questionnaires for patients' preference and values when developing clinical practice guidelines. Further study should be conducted to develop standardized instruments to measure patients' preference and values. It is suggested that the factors this study provides can be used in formulating questionnaires on patients' preference and values.
Lung cancer is the highest morbidity of malignant tumor in China, and bone metastasis is one of the common sites. With the development of imaging and nuclear medicine technology, the level of early diagnosis of bone metastasis has been improved. There are also many evidence-based evidences and advances in systemic therapy (chemotherapy, targeted therapy, immunotherapy) and bone modification drugs for treatment of bone metastases from lung cancer. The comprehensive treatment model under the guidance of multiple disciplines (including medical oncology, surgery, radiotherapy, interventional medicine, nuclear medicine, psychological rehabilitation, etc.) has been widely implemented in clinical practice. Therefore, Lung Cancer Medical Education Committee of China Medicine Education Association, Youth Specialists Committee of Lung Cancer, Beijing Medical Award Foundation and Lung Cancer Specialty Committee of Chinese Elderly Health Care Association have written the "Chinese Clinical Guidelines on Diagnosis and Treatment of Lung Cancer Bone Metastasis (Version 2024)", based on the "Expert Consensus on Diagnosis and Treatment of Lung Cancer Bone Metastasis (Version 2019)". The aim is to enhance the comprehensive treatment level of lung cancer bone metastasis in China.