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.
ObjectiveTo explore the effectiveness and safety of high intensity focused ultrasound (HIFU) in the treatment of pancreatic cancer, so as to provide references for its clinical application. MethodsPubMed, EMbase, The Cochrane Library (Issue 11, 2013), CBM, CNKI, VIP and WanFang Data were systematically searched up to November 2013 for randomized clinical trials (RCTs) and clinical controlled trials (CCTs) about HIFU in the treatment of pancreatic cancer. According to inclusion and exclusion criteria, two reviewers independently screened literature, extracted data, and assessed methodological quality of included studies. Then meta-analysis was performed using RevMan 5.0. ResultsA total of 23 studies (19 RCTs and 4 CCTs) were included, of which 14 studies reported safety. The results of meta-analysis showed that:survival rates at the 6th month and the 12th month, overall efficacy and clinical benefit rate in the HIFU plus radiation and chemotherapy group were significantly higher than those in groups treated with three dimensional conformal radiation therapy (3D-CRT) (P < 0.05), gemcitabine (GEM) (P < 0.05), GEM plus cisplatin (DDP) (P < 0.05), and GEM plus 5-fluorouracil (5-FU) (P < 0.05). The adverse effects (mainly including skin damage and fever) in the HIFU plus radiation and chemotherapy group was similar to those in the control group with no significant difference (P > 0.05). ConclusionCurrent evidence suggests that HIFU plus radiation and chemotherapy for pancreatic cancer is superior to other therapies with less adverse reaction. However, the poor quality of the included studies reduces the reliability of outcome to some extent. Thus, it is necessary to regulate and unify the criteria of diagnosis and outcome measures in the treatment of pancreatic cancer and improve the quality of study design and implementation in clinical studies, so as to provide high quality evidence for its clinical application.
ObjectiveTo explore the effectiveness and safety of high-intensity focused ultrasound (HIFU) for bone tumors, so as to provide a reference for clinical decision. MethodsPubMed, EMbase, The Cochrane Library, CNKI and VIP databases were systematically searched for clinical effectiveness and safety studies of HIFU for bone tumors up to August 2014. Study selection, data extraction and quality assessment were applied independently by two reviewers, and then RevMan 5.1 software was used for conducting meta-analysis. If the data cannot be synthesized, the research outcome was described with a qualitative analysis. ResultsA total of 10 case series including 257 patients (157 males, 100 females) were included. The current evidence indicated that overall survival rates for all primary bone malignancy at 1-, 2-, 3- and 5-year were 89.8%, 72.3%, 60.5% and 50.5%, respectively. For the patients with clinical stage Ⅱb, the rates were 93.3%, 82.4%, 75% and 63.7%, respectively. For those with clinical stage Ⅲ, the rates were 79.2%, 42.2%, 21.1% and 15.8%, respectively. The local recurrence rate of HIFU for bone tumors was 7% to 9%, and recurrences at 1-, 2-, 3- and 5-year were 0%, 6.2%, 11.8% and 11.8%, respectively. The amputation rate was 2% to 7%. The adverse reaction rate was 27.2% (70/257), and among them the main was mild skin burn (21/257, 8.2%), followed by I degree burns (16/257, 6.2%), nerve damage (10/257, 3.9%) and fracture (6/257, 2.3%). ConclusionHIFU provide an alternative choice for patients with bone malignancy, with a certain effectiveness and safety. However, high-quality, large-scale randomized controlled trials or cohort studies which may focus on vary kinds of tumors, clinical stage and site of lesions are urgently needed, so that clinicians can use sufficient evidence for their clinical decision-making.
The latest global big data evidence indicated the changes of skin and venereal disease burden was huge. HIV/AIDS disease burden was the heaviest diseases among all skin and venereal diseases, and its skin manifestation was serious. The evidence of skin manifestation was searched and classified by subjects such as clinical symptoms, diagnosis & treatment, nursing, etc. The results showed, that the skin manifestation of HIV/AIDS with high incidence was serious, atypical, difficult to cure which was easy to misdiagnose or miss diagnosis. After analyzing the global HIV/AIDS guidelines, we found that many high quality guidelines with widely-covered subjects were produced by developed countries, while quite a few low quality and ones with narrowly-covered subjects were produced by developing countries. Only one guideline was for treatment of HIV/AIDS skin lesion. Based on the current evidence, we call for that all healthcare professionals to increase their awareness, update knowledge, and joint in cooperative prevention and treatment of HIV/AIDS. We also call for that we should produce high quality primary evidence for clinical diagnosis and treatment of HIV/AIDS skin manifestation, and clinical practice guidelines based on good evidence. For the increasing heavy burden of skin and venereal diseases, we should adjust and expand research directions, enrich and improve new interdisciplinary knowledge. We also should constantly train professionals and spread out knowledge in public on prevention and treatment for skin manifestation, so as to transform the evidence in time, effectively protect medical staff and susceptible population, effectively prevent and treat this disease, and improve the satisfaction of our country, hospitals and patients.
ObjectiveTo systematically evaluate the effect of combination of motherwort injection and oxytocin for promoting the involution of uterus. MethodsData of randomized controlled trials (RCTs) of motherwort injection and oxytocin in promoting the effect of postpartum involution of uterus were collected by searching the electronic databases including PubMed, EMbase, CNKI, WanFang Data, CENTRAL and WHO ICTRP from inception to August 26th, 2016. Two reviewers independently screened literatures according to the inclusion and exclusion criteria, extracted data, and assessed the risk of bias of included studies. Meta-analysis was conducted by RevMan 5.3 software. ResultsA total of 18 RCTs involving 6 468 patients were included. The results of meta-analysis showed that:Compared with the oxytocin alone group, the combination group of motherwort injection and oxytocin was higher on promoting the drop height of uterus (MD=1.33, 95%CI 1.03 to 1.63), lower on the height of uterus (MD=-2.12, 95%CI -2.64 to -1.61) and duration of lochia (MD=-7.11, 95%CI -8.84 to -5.38). There was no statistical difference in adverse effect rate between the two groups (OR=0.87, 95%CI 0.64 to 1.19, P=0.38). ConclusionsMotherwort injection combined with oxytocin is superior to oxytocin alone in promoting the drop height of postpartum uterus and shortening the duration of lochia. Because of the low quality of the included studies, more high quality RCTs are needed to prove the above conclusion.
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.
ObjectiveTo learn the development and implementation of orphan drug policies, in order to provide decision-making references for the establishment of orphan drug policy according with China's national conditions. MethodsWe electronically searched databases including CBM, CNKI, VIP, EMbase, PubMed, Web of Knowledge, National Library of Medicine, CRD database, The Campbell Library, The Cochrane Library and the drug administration websites of USA, Canada, UK, Ireland, the Netherlands, Germany, Spain, France, Australia, New Zealand, China, India, South Korea, Japan, and South Africa to collect studies about orphan drug policy. The search date was up to February 2014. Two reviewers independently screened literature, and extracted data. Then, all included orphan drug policies were summarized and a comparative analysis was performed. ResultsA total of 110 studies were included. USA, Singapore, Japan, Australia, European Union, Chinese Taiwan and South Korea had introduced orphan drugs incentive policies. South Africa, India, Canada, New Zealand and Chinese Hongkong were producing orphan drugs policy frameworks. The main items of orphan drug policy included marketing exclusivity, tax incentives, technical assistance, grant funding, expedite approval process and prolong re-evaluated time. ConclusionIn mainland China, there is no orphan disease management policy. China should establish specific organization and working procedures, promote orphan drug policy related legislative work, clarify the definition and prevalence of orphan diseases, provide incentive mechanism to promote the research and development of orphan drugs, provide enterprises to develop compensation mechanism to safeguard the rights and interests of patients, as well as establish patients register network platform to track the processes of the diseases.
ObjectiveTo comprehensively collect quality assessment tools of systematic review/meta-analysis (SR/MA) of randomized controlled trials (RCTs), and compare the differences of numbers and contents of items, in order to provide references for optimizing and using these quality assessment tools. MethodsWe searched PubMed and EMbase databases up to December 31th, 2013 for quality assessment tools of SR/MA of RCTs. EndNote X3 software was used for screening literature and Excel 2010 software was used for data extraction. A descriptive analysis was performed. ResultsA total of 61 studies including 32 quality assessment tools were included. Among them, 30 tools were for methodological quality and 2 tools for reporting quality. These tools were developed by different medical universities or colleges, research institutes, national health institutes, and some famous epidemiologists and methodologists from 1984 to 2007. Among the 32 tools, 4 tools were scales, while 28 were checklists. The numbers of items of these tools ranged from 5 to 101, among them, 9 tools had more than 20 items. ConclusionThere are many quality assessment tools for SR/MA, but none of them is generally acknowledged. The quality, contents of items, and applicability of these tools are different, and some of them are too long to use. In practice and decision-making, most of the tools have the problems of low relevance and applicability. How to regularly use these tools to guide the research, practice and decision-making of SR/MA is still needed to be further researched.
ObjectiveTo systematically review the methodological quality of guidelines concerning attention-deficit/hyperactivity disorder (ADHD) in children and adolescents, and to compare differences and similarities of the drugs recommended, in order to provide guidance for clinical practice. MethodsGuidelines concerning ADHD were electronically retrieved in PubMed, EMbase, VIP, WanFang Data, CNKI, NGC (National Guideline Clearinghouse), GIN (Guidelines International Network), NICE (National Institute for Health and Clinical Excellence) from inception to December 2013. The methodological quality of included guidelines were evaluated according to the AGREE Ⅱ instrument, and the differences between recommendations were compared. ResultsA total of 9 guidelines concerning ADHD in children and adolescents were included, with development time ranging from 2004 to 2012. Among 9 guidelines, 4 were made by the USA, 3 in Europe and 2 by UK. The levels of recommendations were Level A for 2 guidelines, and Level B for 7 guidelines. The scores of guidelines according to the domains of AGREE Ⅱ decreased from "clarity of presentations", "scope and purpose", "participants", "applicability", "rigour of development" and "editorial independence". Three evidence-based guidelines scored the top three in the domain of "rigour of development". There were slightly differences in the recommendations of different guidelines. ConclusionThe overall methodological quality of ADHD guidelines is suboptimal in different countries or regions. The 6 domains involving 23 items in AGREE Ⅱ vary with scores, while the scores of evidence-base guidelines are higher than those of non-evidence-based guidelines. The guidelines on ADHD in children and adolescents should be improved in "rigour of development" and "applicability" in future. Conflicts of interest should be addressed. And the guidelines are recommended to be developed on the basis of methods of evidence-based medicine, and best evidence is recommended.
ObjectiveTo assess the efficacy and safety of focused ultrasound (FU) and microwave therapy (MW) for cervical ectopy (CE). MethodsWe searched the following databases:PubMed, EMbase, The Cochrane Library, CBM, VIP, CNKI and WanFang Data from inception to 30th August 2014. Two reviewers (Tang XL and Gao Z) independently screened literatures according to the inclusion and exclusion criteria, extracted data and assessed the methodological quality of included studies. Then, meta-analysis was performed by using RevMan 5.2.0 software. ResultsA total of 33 randomized controlled trials (RCTs) involving 1 759 patients were included. All the included studies were considered to be at high risk of bias. The results of meta-analysis showed that:compared with MW, FU could significantly reduce the risk of vaginal bleeding (RR=0.09, 95%CI 0.05 to 0.17, P<0.000 01) and vaginal discharge (RR=0.10, 95%CI 0.04 to 0.24, P<0.000 01), increase cure rate (RR=1.10, 95%CI 1.05 to 1.15, P<0.000 1) and total effective rate (RR=1.04, 95%CI 1.02 to 1.06, P=0.000 5). However, there was no difference in decreasing recurrence rate (RR=0.13, 95%CI 0.02 to 1.00, P=0.05). ConclusionCurrent available evidence suggest that FU is safer and more effective than MW for treating CE. Due to the limitation of quality of included studies, more high quality RCTs are needed to verify the above conclusion.