Assessment of the abstract reporting of systematic reviews of dose-response meta-analysis: a literature survey.

BACKGROUND: There is an increasing number of published systematic reviews (SR) of dose-response meta-analyses (DRMAs) over the past decades. However, the quality of abstract reporting of these SR-DRMAs remains to be understood. We conducted a literature survey to investigate the abstract reporting of SR-DRMAs. METHODS: Medline, Embase, and Wiley online Library were searched for eligible SR-DRMAs. The reporting quality of SR-DRMAs was assessed by the modified PRISMA-for-Abstract checklist (14 items). We summarized the adherence rate of each item and categorized them as well complied (adhered by 80% or above), moderately complied (50 to 79%), and poorly complied (less than 50%). We used total score to reflect the abstract quality and regression analysis was employed to explore the potential influence factors for it. RESULTS: We included 529 SR-DRMAs. Eight of 14 items were moderately (3 items) or poorly complied (5 items) while only 6 were well complied by these SR-DRMAs. Most of the SR-DRMAs failed to describe the methods for risk of bias assessment (30.2, 95% CI: 26.4, 34.4%) and the results of bias assessment (48.8, 95% CI: 44.4, 53.1%). Few SR-DRMAs reported the funding (2.3, 95% CI: 1.2, 3.9%) and registration (0.6, 95% CI: 0.1, 1.6%) information in the abstract. Multivariable regression analysis suggested word number of abstracts [> 250 vs. ≤ 250 (estimated ß = 0.31; 95% CI: 0.02, 0.61; P = 0.039)] was positively associated with the abstract reporting quality. CONCLUSION: The abstract reporting of SR-DRMAs is suboptimal, substantial effort is needed to improve the reporting. More word number may benefit for the abstract reporting. Given that reporting of abstract largely depends on the reporting and conduct of the SR-DRMA, review authors should also focus on the completeness of SR-DRMA itself.

Cisplatin for testicular germ cell tumors: a rapid review.

OBJECTIVE: Cisplatin is one of efficacious medicines for TGCT, but is not in 18th WHO EML now. The Union for International Cancer Control recommended cisplatin to the 19th WHO EML for TGCT. To evaluate the effectiveness, safety and cost of cisplatin for TGCT according to the requirements of WHO EML Expert Committee, and to provide the evidence whether cisplatin should be included in WHO EML. METHOD: We searched The Cochrane Library, PubMed, EMbase, NHS EED, US National Guideline Clearinghouse (NGC) and WHO guidelines. Guidelines and systematic reviews (SRs) on cisplatin for TGCT were included. Two reviewers selected studies and extracted relevant information independently. Quality of SRs was appraised through AMSTAR. RESULTS: Seven guidelines and four SRs were included in this rapid review. Quality of SRs was moderate according to AMSTAR. The results showed that: (a) effectiveness: cisplatin-based chemotherapy significantly improved in response rates and overall survival for more advanced disease (stage II and stage III). Bleomycin, etoposide, and cisplatin (BEP)-one of the most widely used of cisplatin-based chemotherapy regimens should be considered as the standard treatment of good-prognosis patients with survival rates of 90% and as the best option for intermediate- or poor-prognosis patients with survival rates of 75% and 50%, respectively. (b) Safety: nephrotoxicity, ototoxicity and peripheral neuropathy are common adverse effects of cisplatin. (c) Cost: there was no relevant study about cost of cisplatin for TGCT. But the affordability of cispaltin is good for Chinese patients, due to it is in health insurance directory of China. CONCLUSIONS: We recommend cisplatin to be listed in 19th WHO EML for TGCT, due to adequate evidence of effectiveness and good affordability.

Exploration and practice of methods and processes of evidence-based rapid review on peer review of WHO EML application.

OBJECTIVE: After 38 years of development, the procedure of selection and evaluation of the World Health Organization Essential Medicine List (WHO EML) is increasingly scientific and formal. However, peer review for the applications of World Health Organization Essential Medicine List is always required in a short period. It is necessary to build up a set of methods and processes for rapid review. METHOD: We identified the process of evidenced-based rapid review on WHO EML application for peer reviews according to 11 items which were required during reporting of the peer review results of the proposals. RESULTS: The most important items for the rapid review of World Health Organization Essential Medicine List peer reviewers are (1) to confirm the requirements and identify the purposes; (2) to establish the research questions and translate the questions into the 'Participants, Interventions, Comparators, Outcomes, Study design' (PICOS) format; (3) to search and screen available evidence, for which high-level evidence is preferred, such as systematic reviews or meta-analyses, health technology assessment, clinical guidelines; (4) to extract data, where we extract primary information based on the purposes; (5) to synthesize data by qualitative methods, assess the quality of evidence, and compare the results; (6) to provide the answers to the applications, quality of evidences and strength of recommendations. CONCLUSIONS: Our study established a set of methods and processes for the rapid review of World Health Organization Essential Medicine List peer review, and our findings were used to guide the reviewers to fulfill the 19(th) World Health Organization Essential Medicine List peer review. The methods and processes were feasible and met the necessary requirements in terms of time and quality. Continuous improvement and evaluation in practice are warranted.

Qigong for the primary prevention of cardiovascular disease.

BACKGROUND: Two major determinants of cardiovascular disease (CVD) are a sedentary lifestyle and stress. Qigong involves physical exercise, mind regulation and breathing control to restore the flow of Qi (a pivotal life energy). As it is thought to help reduce stress and involves exercise, qigong may be an effective strategy for the primary prevention of CVD. OBJECTIVES: To determine the effectiveness of qigong for the primary prevention of CVD. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (November 2014, Issue 10 of 12); MEDLINE (Ovid) (1946 to 2014 October week 4); EMBASE Classic + EMBASE (Ovid) (1947 to 2014 November 4); Web of Science Core Collection (1970 to 31 October 2014); Database of Abstracts of Reviews of Effects (DARE), Health Technology Assessment Database and Health Economics Evaluations Database (November 2014, Issue 4 of 4). We searched several Asian databases (inception to July 2013) and the Allied and Complementary Medicine Database (AMED) (inception to December 2013), as well as trial registers and reference lists of reviews and articles; we also approached experts in the field and applied no language restrictions in our search. SELECTION CRITERIA: Randomised controlled trials lasting at least three months involving healthy adults or those at high risk of CVD. Trials examined any type of qigong, and comparison groups provided no intervention or minimal intervention. Outcomes of interest included clinical CVD events and major CVD risk factors. We did not include trials that involved multi-factorial lifestyle interventions or weight loss. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion. Two review authors extracted data from included studies and assessed the risk of bias. MAIN RESULTS: We identified 11 completed trials (1369 participants) and one ongoing trial. Trials were heterogeneous in participants recruited, qigong duration and length of follow-up periods. We were unable to ascertain the risk of bias in nine trials published in Chinese, as insufficient methodological details were reported and we were unable to contact the study authors to clarify this.We performed no meta-analyses, as trials were small and were at significant risk of bias. Clinical events were detailed in subsequent reports of two trials when statistically significant effects of qigong were seen for all-cause mortality, stroke mortality and stroke incidence at 20 to 30 years after completion of the trials. However, these trials were designed to examine outcomes in the short term, and it is not clear whether qigong was practised during extended periods of follow-up; therefore effects cannot be attributed to the intervention. None of the included studies reported other non-fatal CVD events.Six trials provided data that could be used to examine the effects of qigong on blood pressure. Reductions in systolic blood pressure (SBP) and diastolic blood pressure (DBP) were seen in three and two trials, respectively. Three trials examined the effects of qigong on blood lipids when favourable effects were seen in one trial for total cholesterol, low-density lipoprotein (LDL) cholesterol and triglycerides, and two trials showed favourable effects on high-density lipoprotein (HDL) cholesterol. The only trial considered at low risk of selection and detection bias did not demonstrate statistically significant effects on CVD risk factors with qigong, but this study was small and was underpowered. None of the included studies reported incidence of type 2 diabetes (T2D), adverse events, quality of life or costs. AUTHORS' CONCLUSIONS: Currently, very limited evidence is available on the effectiveness of qigong for the primary prevention of CVD. Most of the trials included in this review are likely to be at high risk of bias, so we have very low confidence in the validity of the results. Publication of the ongoing trial will add to the limited evidence base, but further trials of high methodological quality with sufficient sample size and follow-up are needed to be incorporated in an update of this review before the effectiveness of qigong for CVD prevention can be established.

The methodological quality assessment tools for preclinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline: a systematic review.

OBJECTIVE: To systematically review the methodological assessment tools for pre-clinical and clinical studies, systematic review and meta-analysis, and clinical practice guideline. METHODS: We searched PubMed, the Cochrane Handbook for Systematic Reviews of Interventions, Joanna Briggs Institute (JBI) Reviewers Manual, Centre for Reviews and Dissemination, Critical Appraisal Skills Programme (CASP), Scottish Intercollegiate Guidelines Network (SIGN), and the National Institute for Clinical Excellence (NICE) up to May 20th, 2014. Two authors selected studies and extracted data; quantitative analysis was performed to summarize the characteristics of included tools. RESULTS: We included a total of 21 assessment tools for analysis. A number of tools were developed by academic organizations, and some were developed by only a small group of researchers. The JBI developed the highest number of methodological assessment tools, with CASP coming second. Tools for assessing the methodological quality of randomized controlled studies were most abundant. The Cochrane Collaboration's tool for assessing risk of bias is the best available tool for assessing RCTs. For cohort and case-control studies, we recommend the use of the Newcastle-Ottawa Scale. The Methodological Index for Non-Randomized Studies (MINORS) is an excellent tool for assessing non-randomized interventional studies, and the Agency for Healthcare Research and Quality (ARHQ) methodology checklist is applicable for cross-sectional studies. For diagnostic accuracy test studies, the Quality Assessment of Diagnostic Accuracy Studies-2 (QUADAS-2) tool is recommended; the SYstematic Review Centre for Laboratory animal Experimentation (SYRCLE) risk of bias tool is available for assessing animal studies; Assessment of Multiple Systematic Reviews (AMSTAR) is a measurement tool for systematic reviews/meta-analyses; an 18-item tool has been developed for appraising case series studies, and the Appraisal of Guidelines, Research and Evaluation (AGREE)-II instrument is widely used to evaluate clinical practice guidelines. CONCLUSIONS: We have successfully identified a variety of methodological assessment tools for different types of study design. However, further efforts in the development of critical appraisal tools are warranted since there is currently a lack of such tools for other fields, e.g. genetic studies, and some existing tools (nested case-control studies and case reports, for example) are in need of updating to be in line with current research practice and rigor. In addition, it is very important that all critical appraisal tools remain subjective and performance bias is effectively avoided.

Mechanical antithrombotic intervention by LAA occlusion in atrial fibrillation.

Stroke in patients with atrial fibrillation (AF) is often associated with substantial morbidity and mortality. Oral anticoagulation remains the first-line approach to stroke prevention in such individuals; however, for a considerable proportion of patients, traditional treatment using warfarin is limited by a number of factors, such as the inconvenience of frequent therapeutic monitoring and the risk of haemorrhage. The development of new oral anticoagulants with improved efficacy and safety profiles has provided viable options for oral anticoagulation therapy in patients with nonvalvular (nonrheumatic AF). Nonetheless, in patients who have an increased risk of major haemorrhage, a nonpharmacological approach to antithrombotic therapy remains an attractive alternative. The left atrial appendage (LAA) has been found to be the source of >90% of thrombi in patients with nonvalvular AF; thus, prevention of thrombus formation via transcatheter mechanical LAA occlusion is a novel therapeutic target for stroke prevention in this patient population. In this Review, we present the rationale for LAA occlusion in patients with AF, the available occlusion devices and their clinical evidence to date. We also discuss the roles of various imaging techniques in device implantation and the management strategy for associated procedural complications.

The need for multicentre cardiovascular clinical trials in Asia.

Historically, the USA and European countries have been the dominant figures in medical research. However, in the past 10 years, Asia has emerged as a new 'hot spot' for clinical research owing to the tremendous potential generated by steady economic growth, remarkable advances in research and development capacity, and an expanding population. However, investigators involved with the set-up and conduct of multicentre trials in such a vast and heterogeneous continent face huge challenges-bridging the fundamental differences between the Asian countries, such as languages, resources, regulatory procedural timelines, and the general understanding of clinical research. In this Perspectives article, we explain why Asia should be established as a hub for large multicentre trials, discuss the challenges involved, and highlight the importance of a strong collaborative infrastructure for multiple investigational sites in this culturally diverse continent.