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.
Objective To investigate and analyze the status of clinical guidelines of children in China, so as to regulate the development of children’s evidence-based clinical guidelines and provide recommendations for children’s clinical guidelines. Methods Names of guidelines, year and institution of publication, methodology of development and reference number were descriptively analyzed. Years of publication and diseases of guidelines were analyzed with statistical graphs. AGREE instrument was used to evaluate the evidence-based guidelines of children. Results a) Of 91 clinical guidelines of children, 62 were translations. Of 29 guidelines ourselves, nine were traditional Chinese medicine guidelines and five (17%) were evidence-based guidelines; b) Guideline on Rational Use of Antibiotics in Acute Respiratory Infections (Probation), the first guideline of children, was published in 1999. Guidelines of children was not published until 2005. Then, the number of guidelines was increasing each year and reached a peak in 2008. Of 13 guidelines in 2008, seven were traditional Chinese medicine guidelines. Guidelines on respiratory diseases were 14 ranked as the top; c) Guidelines on congenital deformity and chromosomal abnormalities, tumor, circulatory system disease, blood disease and western guideline on communicable disease were not formulated in China; and d) Average scores on six domain of five evidence-based guidelines were 84.4%, 37.5%, 74.3%, 90.0%, 22.2%, 46.6%, respectively. Guide on Diagnosis and Treatment of Children Aged 0 to 5 with Acute Fever of Unknown Etiology was bly recommended, Guide on Management of Children with Community-Acquired Pneumonia, Evidence-Based Guide on Diagnosis and Treatment of Children with Common Kidney Disease, Guide on Nutrition Support of Newborn, Guide on Diagnosis and Treatment of Children with Chronic Cough were recommended. Conclusion Clinical guidelines of children in China begin late, develop slowly and are lack of update. A standard on development of guidelines is needed. The government should increase the fund of development, implementation and promotion of guidelines. Recommendations for high-quality guidelines should be included in procedure of medical quality assurance. Compliance of guidelines should be provided by organization which formulatesd the guideline, so as to promote the application of high-quality guidelines.
Objective To review and evaluate the basic contents and development of the current global clinical guidelines for lung cancer practice so as to provide useful information for domestic study. Methods Six databases including PubMed (to June 2008) and relevant websites (both in Chinese and English) were searched. Articles were screened according to the predefined inclusion and exclusion criteria. The number of clinical guidelines was counted and the quality of guidelines was also assessed. Results A total of 208 articles were found to be clinical guideline-related and 133 were finally included. Of those, 78 were original versions and 55 were updated versions. And 86 articles mentioned guideline development methodology. The guidelines were issued by 14 countries/regions, mainly by USA (39.85%), Canada (24.81%) and France (8.27%). The earliest one was published by USA in 1984. 125 guidelines were issued by oncological or thoracic institutions, and the other 8 were not issued by specialized institutions or not specified. The 133 articles were classified into 3 major clinical categories: synthesis (24), multi-subject (21) and single-subject (88). As for quality evaluation, the average score of all guidelines was 72.09 (full score 100). The highest average score was found in 1996 which was 83.50, and the lowest in 1997 (66.80). The guidelines issued by France had the highest average score (79.80), and Japan, with the lowest average score (48.00). The average score of 4 categories of lung cancer were 73.54 (non-smallcell lung cancer), 65.74 (lung cancer), 74.72 (small-cell lung cancer), and 76.00 (bronchogenic lung cancer), respectively. Conclusion The number of clinical guidelines showed an increasing trend. Most guidelines were issued by developed countries. The subjects included in the synthetic guidelines showed an expanding trend covering about 20 subjects from prevention to palliative care. A trend of multi-country contribution to the guidelines development and revision was noted. Researches became more focused on different types and stages. Evidence-based methodology was accepted globally in the clinical guideline development, but unfortunately very few applied the method of health technology assessment. China issued only 2 original guidelines, which were based on literature review and expert opinions, respectively. Due to the limitation of language restriction, inaccessibility of full-text articles and unavailability of authorized and specific quality evaluation protocols, the conclusions of this study should be interpreted with caution.
ObjectiveTo evaluate the quality of pancreatic cancer guidelines using evidence-based methods based on the global burden of pancreatic cancer, so as to explore its status, region distribution, characteristics of coverage themes, and difference of therapies recommended by the guidelines of various quality, and to provide references for clinical decisionmaking. MethodsPubMed, The Cochrane Library (Issue 11, 2013), CBM, CNKI, and VIP, as well as the website of National Guidelines Clearinghouse (NGC), Guidelines International Network (GIN), and National Institute for Clinical Excellence (NICE) were systematically searched for pancreatic cancer treatment guidelines. The Appraisal of Guidelines for Research and Evaluation (AGREE Ⅲ) was applied to assess methodological quality of included guidelines. ResultsA total of 14 relevant guidelines (including five evidence-based guidelines) were included involving seven countries of four continents (Asia, Europe, North America and Oceania) and four international academic organizations. There were only two domains, namely "scope and purpose" and "clarity of presentations" which got high average scores (more than 60%) among all 14 guidelines. The mean AGREE domain scores in guidelines varied with areas, and the quality of five evidence-based guidelines was superior to that established by consensus. According to the outcomes of AGREE Ⅲ, 11 guidelines were weakly recommended, while 3 were not recommended due to poor methodological quality. The subjects of 14 guidelines covered six treatment categories, including chemotherapy, surgery, radiotherapy, support therapy, radiotherapy, and interventional therapy. ConclusionThe overall methodological quality of pancreatic cancer guidelines is not high among different countries or regions. The quality of evidence-based guidelines is superior to that established by consensus. Chemotherapy, surgery, radiotherapy and support therapy were reccommended as predominant choice by these guidelines.
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.
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.
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.