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.
Objective To evaluate and select essential antihypertensive medicine using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Five clinical guidelines on hypertension were included, two of which were evidence-based. (2) Totally there were nine classes and 70 antihypertensive medicines listed in the guidelines. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines, and the quantity and quality of evidence, we offered a b recommendation for nifedipine, verapamil and enalapril and a weak recommendation for hydrochlorothiazide, indapamide, spironolactone, propranolol, metoprolol and amlodipine. We made a recommendation against furosemide and timolol due to the lack of evidence from guidelines. (4) Nine recommended medicines have been marketed with the dosage forms and specifications corresponding to guidelines in China. The prices of metoprolol, amlodipine and enalapril were higher than those of other six (daily cost: metoprolol 3.80 to 7.60 yuan, amlodipine 2.16 to 4.32 yuan, and enalapril 0.86 to 6.88 yuan). As a whole, the prices of recommended antihypertensive medicine were affordable. (5) Results of domestic studies indicated that three bly-recommended medicines (including nifedipine, verapamil and enalapril) were safe, effective, economical and applicable. Conclusion (1) We offer a b recommendation for nifedipine, verapamil and enalapril as antihypertensive medicine and a weak recommendation for hydrochlorothiazide, indapamide, spironolactone, propranolol, metoprolol and amlodipine. (2) There is lack of high-quality evidence from relevant domestic studies, especially on long-term safety and pharmacoeconomic evidence. (3) We propose that more studies should be carried out on the safety, efficacy and pharmacoeconomics of six medicines for which we make a weak recommendation to produce high-quality local evidence.
Objective To evaluate and select essential medicine for acute bronchitis using evidence-based methods based on the burden of disease. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Eight guidelines were included (seven foreign guidelines, one domestic guideline; five based on evidence, three based on expert consensus). (2) A result of six RCTs (n=816, low quality) indicated that pentoxyverine had efficiencies of 53% to 82% for cough relief. Among the six RCTs, a result of three RCTs (n=283) indicated that pentoxyverine was slightly less efficient than procaterol (RR=0.86, 95%CI 0.78 to 0.94, P=0.001); a result of two RCTs (n=233) indicated that pentoxyverine was slightly less efficient than Chinese medicinals decoction (RR=0.82, 95%CI 0.74 to 0.91, Plt;0.001). Adverse reaction of pentoxyverine (incidence: 0% to 2.4%) mainly covered nausea, palpitation, etc. Pentoxyverine cost 0.20 yuan (for adult) or 0.08 yuan (for child) daily, which was orally taken and applicable to the target population. (3) A result of six RCTs (n=403, low quality) indicated that the efficiencies of dextromethorphan for cough relief was 47.0% to 95.3%. Among the six RCTs, a result of one RCT (n=283) indicated that dextromethorphan hydrobromide (nasal drop) was more efficient than blank intervention (RR=3.71, 95%CI 1.91 to 7.21); a result of one RCT (n=43) indicated that dextromethorphan (for oral use) was more efficient than placebo (RR=1.74, 95%CI 1.13 to 2.66); a result of one RCT (n=300, moderate quality) indicated that dextromethorphan was more efficient than pentoxyverine (RR=1.16, 95%CI 1.07 to 1.26); a result of one observational study (n=121, low quality) indicated that dextromethorphan given for 5 days had an efficiency of 66.5%. Adverse reaction of dextromethorphan (incidence: 2% to 30%) mainly covered mouth dryness, dizziness, nausea, etc. Conclusion (1) We offer a b recommendation for dextromethorphan used in relieving dry cough due to acute bronchitis. (2) We offer a weak recommendation for pentoxyverine as symptomatic treatment for cough relief. (3) We make a recommendation against antibiotics, β2-agonist bronchodilators and mucolytic agents as routine use. (4) More large-scale, multi-center, double-blinded RCTs are needed in clinical and pharmacoeconomic studies of acute bronchitis in hopes of producing high-quality local evidence.
Objective To evaluate and select essential medicine for the treatment of coronary heart disease by means of evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) 11 clinical guidelines on coronary heart disease were included, three of which are evidence-based guidelines. (2) Totally, those guidelines contained 61 medicines (of 13 classes). (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence, we made a b recommendation for nitroglycerin, isosorbide dinitrate, metoprolol, nifedipine, verapamil, enalapril and aspirin as essential medicine for coronary heart disease. We made a weak recommendation for amlodipine, clopidogrel, heparin, propranolol, simvastatin and streptokinase. (4) 13 recommended medicines have been marketed in China and their prices were affordable. (5) Results of domestic low-quality studies indicated that nitroglycerin, isosorbide dinitrate, metoprolol, aspirin and heparin were effective for coronary heart disease. We didn’t find systematic reviews or pharmacoeconomic studies on the recommended medicines in Chinese literature databases. Conclusion For coronary heart disease: (1) We offer a b recommendation for nitroglycerin, isosorbide dinitrate, metoprolol, nifedipine, verapamil, enalapril and aspirin and a weak recommendation for propranolol, amlodipine, clopidogrel, heparin, simvastatin and streptokinase. (2) There is lack of high-quality evidence from relevant domestic studies, especially on pharmacoeconomic evaluation. (3) We propose that more studies should be carried out on clinical guideline of coronary heart disease and pharmacoeconomic comparison should be also made between recommended medicine and medicine of the same class.
Objective To review and evaluate the global clinical research literatures about the surgical management for prostatic abscess in the past decade, so as to provide useful information for clinical practice. Methods Based on the principles of evidence-based medicine, and the methods of bibliometrics, the PubMed database was searched from January 1st 2000 to April 10th 2011. The literatures about prostatic abscess were screened according to the predefined inclusion and exclusion criteria, the quality was assessed, the valid data were extracted and then systematical evaluation was performed after the establishment of the database with OpenOffice.org 3.8 Calc. Results a) A total of 205 articles were found initially and 81 were finally included with the total 388 cases involved (on average, 4.79 cases per paper). The patients’ ages ranged from 10 days to 83 years old. Two studies were diagnostic tests, and all the other 79 were surgical intervention studies; b) There was no controlled clinical trail. A total of 16 studies involving more than 5 cases for each and 311 cases in all which were retrospective case analyses, all the other 65 were individual case reports; c) American scholars published 13 papers (16.5%), ranked as the first. American and European scientists published 36 papers (44.44%). Chinese scholars published quite fewer studies, of which only 2 were in English; d) The incidence increased in younger patients gradually. The pathogens included fungi and bacteria. Most bacteria were gram-positive cocci (such as Staphylococci), followed by gram-negative bacillus (such as Klebsiella). There were also some minority pathogens. The pathogens were complex and quite diverse in different districts. The predisposing factors included both regional and systematic conditions, with diabetes mellitus, hepatocirrhosis, manipulations of lower urinary tract and urinary tract infections as the common; e) The diagnostic procedures included evaluation on symptoms and signs, physical examination, identification of pathogens, and medical imaging examinations (TRUS, CT, MRI). The therapeutic options included routine managements, conservative antibiotic therapies and surgical drainages. The surgical routes were transcutaneous, transperineal, transrectal, and transurethral. The fine needle aspiration, indwelling catheter drainage, or incision and drainage were performed under the guidance of TRUS, EUS or CT through transperineal or transrectal routes. The TUR, TURP or TUIP drainages were performed through transurethral route. The failed cases of fine needle aspiration were then treated by transurethral or transperineal incision and drainages, and some patients were also treated by urinary diversion; f) The best surgical method could not be concluded for lack of controlled data; and g) Few cases died from severe complications, and the outcomes of the majority cases were good. Conclusion a) The literatures about prostatic abscess are abundant but of low quality, with all retrospective studies or individual case reports, and most are published by American and European scholars; b) The prostatic abscess affects all ages but tends to increase in the young. Most pathogens are the gram-positive cocci (such as Staphylococci) ranked as the top and followed by gram-negative bacillus (such as Klebsiella), and the pathogens are obviously diverse in different districts; c) The predisposing factors are commonly seen as diabetes mellitus, hepatocirrhosis, manipulations of lower urinary tract and urinary tract infections; ......
Objective To evaluate and select essential medicine for children with fever and adult gastrointestinal flu caused by common cold using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) 12 guidelines were included, 11 of which were evidence-based or based on expert consensus. We offered a recommendation for medicines used in the treatment including analgesics and antipyretics, decongestants, antihistamines, cough-relieving drug, phlegm-removing drug and drug for gastrointestinal symptoms. (2) A result of four RCTs (very low quality) indicated that in the treatment of children with cold, ibuprofen suspension had an antipyretic effect similar to paracetamol solution (for oral use) with a pooled result of 6-hour efficiency in relieving fever (RR 1.48, 95%CI 0.66 to 3.30, P=0.34). The major adverse effects of ibuprofen suspension included gastrointestinal reaction and profuse sweats (RR=1.23, 95%CI 0.72 to 2.11, P=0.45). With good applicability, ibuprofen suspension (for oral use with no need to be supervised) cost 1.93 yuan daily. (3) A result of three RCTs (low quality) indicated that after given for 30 minutes and one hour, paracetamol solution (suppository) was fairly superior to ibuprofen suspension in lowering the high temperature caused by fever (given for 30 min: MD= –0.16°C, 95%CI –0.21 to –0.11, Plt;0.01; given for one hour: MD= –0.19°C, 95%CI –0.28 to 0.10, Plt;0.01). As to adverse reaction, paracetamol solution (suppository) mainly included anal irritation, skin rashes and profuse sweats, which had a comparative result of incidence with ibuprofen suspension (RR=1.84, 95%CI 0.62 to 5.44, P=0.27). For children with fever, paracetamol solution (suppository) cost 0.90 yuan daily. With good applicability, paracetamol solution (suppository) was administered via the anus. Conclusion (1) We offer a b recommendation for ibuprofen suspension (2 g/100 mL) or acetaminophen (0.1 g/suppository) as symptomatic treatment used in children with fever, pain and discomfort caused by common cold, and for Huo Xiang Zheng Qi Jiao Nang (0.3 g/ capsule) used in adults with gastrointestinal flu. We also offer a weak recommendation for acetylcysteine (injection, 300 mg/mL, 10 mL/ampoule) used in patients with paracetamol poisoning. (2) In order to produce high-quality local evidence, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on ibuprofen suspension and acetaminophen suppository in the treatment of children with fever, pain and discomfort caused by common cold should be further carried out. Besides, we proposed that large-scale, well-designed, high-quality clinical and pharmacoeconomic studies on Chinese patent drugs of Huo Xiang Zheng Qi used in chidren and Huo Xiang Zheng Qi Jiao Nang used in adults should further carried out. Moreover, we suggest that epidemiological investigation as well as clinical and pharmacoeconomic studies of acetylcysteine injection for paracetamol poisoning should be carried out and the instructions of acetylcysteine injection should be added in the guidelines of essential medicine in China. Finally, further studies on evidence of oxymetazoline, dextromethorphan and other Chinese patent drugs with the effect of relieving cough and treating cold should be carried out.
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.
Objective To evaluate and select essential medicine for acute gastroenteritis using evidence-based approaches based on the burden of disease for township health centers located in eastern, central and western regions of China. Methods By means of the approaches, criteria, and workflow set up in the second article of this series, we referred to the recommendations of evidence-based or authority guidelines from inside and outside China, collected relevant evidence from domestic clinical studies, and recommended essential medicine based on evidence-based evaluation. Data were analyzed by Review Manager (RevMan) 5.1 and GRADE profiler 3.6 to evaluate quality of evidence. Results (1) Five guidelines were included, two of which were evidence-based. (2) Recommended medicines included eight antidiarrheals (of four classes) and three antemetics. (3) According to WHOEML (2011), NEML (2009), CNF (2010), other guidelines and the quantity and quality of evidence, we offered a weak recommendation for ondansetron, metoclopramide, smectite, racecadotril and loperamide applied in the treatment of acute gastroenteritis. We made a recommendation against antibiotics, dexamethasone, kaolin-pectin, activated charcoal, attapulgite and bismuth subsalicylate. (4) Evidence from domestic studies: a result of 14 CCTs (n=1 635, low quality) indicated that in the significant efficiency and total efficiency, smectite (smecta) was superior to routine liquid infusion, norfloxacin, gentamicin or furaxone. Among these 14 CCTs, two CCTs reported smectite (smecta) caused nausea and vomiting (three cases); one CCT reported pain and distention in the abdomen (one case) and general discomfort (one case); and the rest reported no adverse reaction. A result of 10 CCTs (n=1 017, low quality) indicated that for acute diarrhea, racecadotril was superior to routine treatment in the significant efficiency (OR=2.55, 95%CI 1.64 to 3.94, Plt;0.01) and total efficiency (OR=4.32, 95%CI 2.96 to 6.30, Plt;0.01). A result of two CCTs (n=344, low quality) indicated that racecadotril was superior to smectite in the total efficiency in treating acute diarrhea. A result of two CCTs (n=1 056, low quality) indicated that racecadotril was superior to routine treatment in the total efficiency in treating acute adult diarrhea (OR=5.19, 95%CI 3.54 to 7.63, Plt;0.01). A result of two CCTs (n=182, low quality) reported children presented with nausea (two cases). A result of one CCT (n=947, low quality) reported adults presented with constipation (fifteen cases), anorexia (four cases), headache (nine cases) and abdominal pain (one case). Conclusion For acute gastroentitis, we offer a weak recommendation for smectite (powder, for oral use) used in adults (once 3 g, tid., mixed with warm water before intake), child under one year of age (3 g daily, bid.), and child above one year of age (once 3 g, qd. or bid.). Retention enema could be appiled to children with acute gastroenteritis. We also offer a weak recommendation for racecadotril (capsule) used in adults (one capsule, tid., taken continuously less than seven days). Due to the lack of evidence from clinical trials, we make a recommendation against racecadotril applied to women with pregnancy and lactation or children. In order to produce high-quality local evidence, we propose that (1) Further clinical studies should be standardized in diagnosis and criteria. (2) The design and implementation quality of clinical studies should be improved. (3) Original studies on pharmacoeconomic studies and drug applicability are needed.
ObjectiveTo investigate the type, development time, regional distribution, development methods, structure and contents of therapeutic drug monitoring (TDM) guidelines, so as to provide references for the development of TDM guidelines in China. MethodsGuidelines concerning TDM were electronically retrieved in PubMed, Ovid-EMbase, CNKI, VIP, CBM, WanFang Data, NGC (National Guideline Clearinghouse ), GIN (Guidelines International Network), World Health Organization (WHO) guideline database, official websites of governments and societies associated with TDM from inception to October 2015. Two reviewers independently screened literature, extracted data including basic characteristics, formulation methods and text structure, etc.. Then a descriptive analysis was conducted. ResultsA total of 37 guidelines concerning TDM were included, which involved 4 guidelines for management of TDM, 32 for technical practice and 1 for both of them. The results of analysis showed that: for the integrity of reporting items of guidelines, three (75%) management guidelines ranked grade A, but only 1 (3.13%) technical guidelines ranked grade A. The management specifications of TDM included four aspects as follows: standard terminology, the process specification, quality control and personnel qualification. The recommendations to TDM technology of specific drugs included evidence of TDM, standards and procedures, and personnel qualification. ConclusionThere is a rapid but unbalanced development for abroad TDM guidelines. Most of them are TDM technical guidelines. Evidence-based methods are suggested to be used to develop local TDM guidelines, especially for commonly used medicines and technologies without supporting of existed guidelines.