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.
Objective To investigate the awareness of rational use of drug (RUD) on medical workers in hospitals of different ranks, the establishment and execution of relevant strategies in hospitals of different ranks, and the main factors affecting RUD on medical workers, so as to provide references for the generalization of RUD. Methods A certain number of different ranks of hospitals in Chengdu and Zigong were randomly selected by the convenience sample method. Medical workers in each hospital were selected through face-to-face interviews with a self-designed questionnaire. Monte Carlo Chi-square analysis was applied on the hospital ranks and formulation of RUD guidelines, and logistic regression analysis was performed on the awareness of RUD knowledge of the respondents. Results Among 700 questionnaires distributed, 672 were retrieved (response rate 96.0%). The numbers of respondents who were familiar with the Pharmaceutical Affairs Councils (PACs) as well as the Pharmacy and Therapeutics Committees (PTCs) were 217 (32.29%) and 83 (12.35%), respectively. The number of respondents who understood the concept of essential medicine was 502 (74.71%). A total of 441 (61.16%) medical workers had been trained on RUD, 199 (29.61%) medical workers denied there were PTCs in their hospitals, and 60.71% of the medical workers mentioned that the use of drug was monitored and controlled with the feedback in their hospitals. The result of logistic regression analysis indicated that the professional title (P=0.038), awareness of essential medicine (Plt;0.001) and participation of RUD training (P=0.008) were the factors influencing the awareness of RUD. Conclusion Both management and education should be executed at the same time to elevate the level of rational use of drug. In order to increase the level of RUD we should complete monitoring institution and improving RUD awareness of workers. Additionally enhancing the rationality of medication should be performed by establishing guidelines of treatment or medication. Improving personal knowledge, scientific information and medication custom should be performed by standardizing regulations, strengthening management, emphasizing education and promoting communication between doctors and patients.
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.
ObjectivesTo systematically evaluate the structure, publication type and contents of current guidelines for guideline development, so as to provide methodology references for guideline development in China. MethodsSix biomedical research literature databases, six guideline databases and 18 websites of academic institutions and health administrative departments were searched to locate guidelines for guideline development. We included the latest versions of guidelines from guideline development departments or academic institutions. We extracted information consisting of general guideline information, structure, principles, methods and procedure of guideline development. A descriptive analysis was conducted to analyze the general information, structure, principles, methods and procedure of guidelines among different guidelines for guideline development. ResultsAmong all the included 25 guidelines for guideline development published from 1998 to 2014, 50% of them were from North America. Structure of these guidelines were similar while detail levels of recommended guideline development methods and procedures were slightly different. The guideline development groups, systematic literature search, evidence assessment and recommendation formulation were vital part of guideline development. The ineffective promotion and implementation of guidelines for guideline development were common problems of current guidelines. ConclusionsProcedures recommended by current guidelines for guideline development are almost the same, but the methods and statements are different. We could develop our own guideline for guideline development based on the current relative high-quality guideline in order to provide guidance to the clinical guideline development in China.
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.
Strengthening the management and evaluation of clinical pathways is one of the most important strategies of "Healthy China 2030" Strategic Plan. Evidence-based assessment and clinical guidelines can provide the best relevant evidence to develop clinical pathways. We planned to analyze the current situation of clinical pathways in China and explore how to apply evidence-based assessment on clinical pathway management. We searched PubMed, EMbase, ISI, CNKI, WanFang Data, VIP and the The Cochrane Library using "critical pathways" and "clinical guidelines" as key words or subject terms. And we conducted a comparison of their published volume, definitions, differences and connections. The management system of clinical pathway in China is fundamentally flawed, it is still a challenge to implement the clinical pathways effectively without scientific methodologies and standardized evidence-based evaluation system. In order to improve the management quality of clinical pathway in China, we should develop clinical pathways based on national situation and innovate the evaluation system to standardize the clinical pathway management according to WHO recommendations of clinical guideline and appraisal.