Systematic Reviews - Latest Articles

Completeness of reporting of setting and health worker cadre among trials on antenatal iron and folic acid supplementation in pregnancy: an assessment based on two Cochrane reviews

Rachel Harper — 2013-06-17T00:00:00Z

Background: Poor reporting of medical trials has triggered the development of trial reporting standards within the scientific community. In addition to a description of the proposed intervention, adequate information about the trial setting and the group of health workers (cadre) delivering the intervention would allow a better understanding of the generalizability of the trial findings, facilitate replication of trial interventions and assist with assessment of trials for inclusion in systematic reviews. This study aims to determine the completeness of reporting for trial setting and cadre among trials included in two Cochrane reviews on iron and folic acid supplementation for women during pregnancy. Methods: From the 81 trials included in the two Cochrane reviews, we extracted data on the trial setting, including the facility type and geographic location, facility descriptors (i.e. level of care) and population descriptors (i.e. socioeconomic status); and the cadre, including professional qualifications, training and supervision. Results: Almost all studies reported the facility type and location (96%). However, only 68% included this information in the "methods" section of the report. Facility descriptors and population descriptors were less commonly reported (26% and 54% respectively). For 34% of the trials, we found some account of the type of health worker that delivered the intervention. Only 4% of the trials reported any training procedures. Conclusions: Currently, complete reporting of setting and health worker cadre in iron and folic acid supplementation in pregnancy trials remains far from ideal, limiting assessments of the applicability of the trial findings. Trialists and journals need to ensure that this information is included in trial reports by adhering to and improving current reporting standards and by not making assumptions regarding readers' knowledge of the context and of the intervention delivery mechanism.

Systematic review of the effectiveness of training programs in writing for scholarly publication, journal editing, and manuscript peer review (protocol)

James Galipeau — 2013-06-17T00:00:00Z

Background: An estimated $100 billion is lost to 'waste' in biomedical research globally, annually, much of which comes from the poor quality of published research. One particular area of waste involves bias in reporting research, which compromises the usability of published reports. In response to this, there has been an upsurge in interest and research in the scientific process of writing, editing, peer reviewing, and publishing (that is, journalology) of biomedical research. One possible reason for bias in reporting and the problem of unusable reports could be due to authors lacking knowledge or engaging in questionable practices while designing, conducting, or reporting their research. Another might be that the peer review process for journal publication has serious flaws, including possibly being ineffective, as well as having poorly trained and poorly motivated reviewers. Similarly, many journal editors have limited knowledge related to publication ethics. This can ultimately have a negative impact on the healthcare system. There have been repeated calls for better, more numerous training opportunities for academic writing, peer review, and publishing. However, little research has taken stock of journalology training opportunities or related evaluations of their effectiveness. Methods: We plan to conduct a systematic review to synthesize studies that evaluate the effectiveness of training programs in journalology. A comprehensive three-phase search approach will be employed to identify evaluations of training opportunities, involving: 1) forward-searching using the Scopus citation database, 2) a search of the MEDLINE In-Process and Non-Indexed Citations, MEDLINE, Embase, ERIC, and PsycINFO databases, as well as the databases of the Cochrane Library, and 3) a grey literature search.DiscussionThis project aims to provide evidence to help guide the journalological training of authors, peer reviewers, and editors, as well as the development of future training opportunities in this domain. While there is ample evidence that many members of these groups are not getting the necessary training needed to excel at their respective journalology-related tasks, little is known about the characteristics of existing training opportunities, including their effectiveness. The proposed systematic review will provide the evidence regarding the effectiveness of training, therefore giving potential trainees, course designers, and decision-makers evidence to help inform their choices and policies regarding the merits of a specific training opportunity or type of training.

A comparative assessment of three formulations of botulinum toxin A for facial rhytides: a systematic review and meta-analyses

James Bonaparte — 2013-06-13T00:00:00Z

Background: Botulinum toxin A is a commonly used biological medication in the field of facial plastic surgery. Currently, there are three distinct formulations of botulinum toxin A, each with their purported benefits and advantages. However, there is considerable confusion as to the relative efficacy and side-effects associated with each formulation. Therefore, the purpose of this paper is to systematically assess published studies and perform a meta-analysis to determine if there is a significant advantage of any of the individual formulations. Methods: A systematic literature search was performed for all relevant English language randomized controlled trials using Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL), MEDLINE, World Health Organization (WHO) International Clinical Trials Registry Platform, European Union (EU) Clinical Trials Register, Cochrane Library databases of clinical trials, and ClinicalTrials.gov. Inclusion criteria included any randomized controlled trial (RCT) that assessed the use of botulinum toxin for cosmetic purposes. The included articles were also analyzed for bias using the Cochrane Collaboration's tool for assessing the risk of bias in RCTs.DiscussionThe results of this review will provide clinicians with an unbiased, high level of evidence of the comparative efficacy of individual preparations of botulinum toxin A.Trial registration: PROSPERO: CRD4201200337.

Clinical risk factors for late intestinal toxicity after radiotherapy: a systematic review protocol

Qiyuan Qin — 2013-06-07T00:00:00Z

Background: Late intestinal toxicity after radiotherapy (LITAR) not only limits the radiation dose, which subsequently leads to unfavorable clinical outcomes, but also significantly lowers the quality of life in an increasing number of cancer survivors. Therefore, identifying clinical risk factors for LITAR is important for establishing a predictive model in the clinical setting of decision-making for these patients. This review aims to systematically summarize and clarify the clinical factors that can be potentially associated with an increased risk of moderate/severe LITAR in patients with abdominal or pelvic malignancies.Methods/designMEDLINE, EMBASE, Web of Science, Cochrane Central Register of Controlled Trials, Scopus, Google Scholar and Chinese BioMed will be systematically searched to identify appropriate studies. Citations of the retrieved studies and recent reviews will also be searched separately by case.The enrolled studies should at least have the following information: (1) a clear definition and information on the LITAR severity; (2) assess clinical factors for moderate/severe toxicity with adjusted risk estimates; (3) have a cohort, case–control, randomized controlled trial and controlled clinical trial study design.Two authors will independently review the abstract and full text of retrieved studies, extract data from eligible studies and assess the risk of bias. Disagreements will be discussed among reviewers until a consensus is reached. The effect of identified risk factors will be displayed in forest plots. If the information is sufficient, results will be synthesized by a meta-analysis with the random effects model to pool the estimate of risk posed by clinical factors. Subgroup and sensitivity analysis will be used to explore the sources of heterogeneity.DiscussionThis review will summarize the evidence of clinical risk factors for moderate/severe LITAR. The results may help guide decision-making and minimize the side effects of therapeutic modalities in the clinical setting.Trial registrationThis review has been registered at PROSPERO. The registration no. is CRD42013003744.

Efficacy of falls prevention interventions: protocol for a systematic review and network meta-analysis

Andrea Tricco — 2013-06-06T00:00:00Z

Background: Falls are a leading cause of morbidity and mortality in older adults. Although numerous trials of falls prevention interventions have been completed, there is extensive variation in their intervention components and clinical context, such that the key elements of an effective falls prevention program remain unclear to patients, clinicians, and policy-makers. Our objective is to identify the most effective interventions and combinations of interventions that prevent falls though a systematic review and meta-analysis, including a network meta-analysis.Methods/DesignWe will search for published (e.g., MEDLINE, EMBASE, Cochrane Central Register of Controlled Trials, Ageline) and unpublished (e.g., trial registries, dissertations) randomised clinical trials (RCTs) in all languages examining interventions to prevent falls compared to usual care or other falls prevention interventions among adults aged ≥65 years from all settings (e.g., community, acute care, long-term care, and rehabilitation). The primary outcomes are number of injurious falls and number of hospitalizations due to falls. Secondary outcomes include falls rate, number of fallers, number of emergency room visits due to falls, number of physician visits due to falls, number of fractures, costs, and number of intervention-related harms (e.g., muscle soreness related to exercise).We will calibrate our eligibility criteria amongst the team and two independent team members will screen the literature search results in duplicate. Conflicts will be resolved through team discussion. A similar process will be used for data abstraction and quality appraisal with the Cochrane risk of bias tool.Our results will be synthesized descriptively and a random effects meta-analysis will be conducted if the studies are deemed methodologically, clinically, and statistically (e.g., I2<60%) similar. If appropriate, a network meta-analysis will be conducted, which will allow the comparison of interventions that have not been compared in head-to-head RCTs, as well as the effectiveness of interventions.DiscussionWe will identify the most effective interventions and combinations of interventions that prevent falls in older people. Our results will be used to optimize falls prevention strategies, and our goal is to ultimately improve the health of seniors internationally.Trial registrationPROSPERO registry number: CRD42013004151

Diagnostic performance of alpha-fetoprotein, lens culinaris agglutinin-reactive alpha-fetoprotein, des-gamma carboxyprothrombin, and glypican-3 for the detection of hepatocellular carcinoma: a systematic review and meta-analysis protocol

Ting-Shuo Huang — 2013-06-06T00:00:00Z

Background: Diagnosis of early-stage hepatocellular carcinoma (HCC) followed by curative resection or liver transplantation offers the best chance for long-term patient survival. Clinically, ultrasonography has suboptimal sensitivity for detecting early-stage HCC. Several serological tests including alpha-fetoprotein (AFP), the ratio of lens culinaris agglutinin-reactive alpha-fetoprotein to total AFP (AFP-L3/AFP), des-gamma carboxyprothrombin (DCP), and glypican-3 (GPC-3) have been widely investigated as diagnostic biomarkers for early-stage HCC in at-risk populations. However, these tests are not recommended for routine HCC screening. Our objective is to determine the diagnostic performance of AFP, AFP-L3/AFP, DCP, and GPC-3 for the detection of HCC, particularly early-stage tumors meeting the Milan criteria.Methods/designWe will include cross-sectional studies that consecutively or randomly recruit target populations. We will search the Cochrane Library, Medline, Embase, Science Citation Index, and the Chinese National Knowledge Infrastructure. We will also search the MEDION and ARIF databases to identify diagnostic systematic reviews that include primary studies. Reference lists of relevant reviews will be searched for additional trials. Language restrictions will not be applied. Two reviewers will independently screen study eligibility and extract data. Methodological quality will be assessed according to the revised tool for the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2). Two authors will apply the QUADAS-2 assessment to all the included studies, and any discrepancies will be resolved by the third author. The following test characteristics will be extracted into 2 × 2 tables for all included studies: true positives, false positives, true negatives, and false negatives. Study-specific estimates of sensitivity and specificity with 95% confidence intervals will be displayed in forest plots. When possible, we will use the bivariate random-effects model or the Rutter and Gatsonis hierarchical summary receiver operating characteristic model for statistical analysis. To investigate heterogeneity, we will include study designs, population characteristics, test characteristics, and types of reference standard as the study-level variables.DiscussionOur systematic review will allow patients, clinicians, and researchers to determine the diagnostic performance of AFP, AFP-L3/AFP, DCP, and GPC-3 for the detection of early-stage HCC and the potential roles of these diagnostic biomarkers in the existing diagnostic pathways.Systematic Review Registration: PROSPERO 2013; CRD42013003879

Are systematic reviews up-to-date at the time of publication?

Elaine Beller — 2013-05-28T00:00:00Z

Background: Systematic reviews provide a synthesis of evidence for practitioners, for clinical practice guideline developers, and for those designing and justifying primary research. Having an up-to-date and comprehensive review is therefore important. Our main objective was to determine the recency of systematic reviews at the time of their publication, as measured by the time from last search date to publication. We also wanted to study the time from search date to acceptance, and from acceptance to publication, and measure the proportion of systematic reviews with recorded information on search dates and information sources in the abstract and full text of the review. Methods: A descriptive analysis of published systematic reviews indexed in Medline in 2009, 2010 and 2011 by three reviewers, independently extracting data. Results: Of the 300 systematic reviews included, 271 (90%) provided the date of search in the full-text article, but only 141 (47%) stated this in the abstract. The median (standard error; minimum to maximum) survival time from last search to acceptance was 5.1 (0.58; 0 to 43.8) months (95% confidence interval = 3.9 to 6.2) and from last search to first publication time was 8.0 (0.35; 0 to 46.7) months (95% confidence interval = 7.3 to 8.7), respectively. Of the 300 reviews, 295 (98%) stated which databases had been searched, but only 181 (60%) stated the databases in the abstract. Most researchers searched three (35%) or four (21%) databases. The top-three most used databases were MEDLINE (79%), Cochrane library (76%), and EMBASE (64%). Conclusions: Being able to identify comprehensive, up-to-date reviews is important to clinicians, guideline groups, and those designing clinical trials. This study demonstrates that some reviews have a considerable delay between search and publication, but only 47% of systematic review abstracts stated the last search date and 60% stated the databases that had been searched. Improvements in the quality of abstracts of systematic reviews and ways to shorten the review and revision processes to make review publication more rapid are needed.

Screening for cervical cancer: a systematic review and meta-analysis

Leslea Peirson — 2013-05-24T00:00:00Z

Background: The systematic review on which this paper is based provided evidence for the Canadian Task Force on Preventive Health Care to update their guideline regarding screening for cervical cancer. In this article we highlight three questions covered in the full review that pertain to the effectiveness of screening for reducing cervical cancer mortality and incidence as well as optimal timing and frequency of screening. Methods: We searched MEDLINE, Embase and Cochrane Central from 1995 to 2012 for relevant randomized controlled trials and observational studies with comparison groups. Eligible studies included women aged 15 to 70 years who were screened using conventional cytology, liquid-based cytology or human papillomavirus DNA tests. Relevance screening, data extraction, risk of bias analyses and quality assessments were performed in duplicate. We conducted a meta-analysis using a random-effects model on the one body of evidence that could be pooled. Results: From the 15,145 screened citations, 27 papers (24 studies) were included; five older studies located in a United States Preventive Services Task Force review were also included. A randomized controlled trial in India showed even a single lifetime screening test significantly decreased the risk of mortality from and incidence of advanced cervical cancer compared to no screening (mortality: risk ratio 0.65, 95% confidence interval 0.47, 0.90; incidence: relative risk 0.56, 95% confidence interval 0.42, 0.75). Cytology screening was shown to be beneficial in a cohort study that found testing significantly reduced the risk of being diagnosed with invasive cervical cancer compared to no screening (risk ratio 0.38; 95% confidence interval 0.23, 0.63). Pooled evidence from a dozen case–control studies also indicated a significant protective effect of cytology screening (odds ratio 0.35; 95% confidence interval 0.30, 0.41). This review found no conclusive evidence for establishing optimal ages to start and stop cervical screening, or to determine how often to screen; however the available data suggests substantial protective effects for screening women 30 years and older and for intervals of up to five years. Conclusions: The available evidence supports the conclusion that cervical screening does offer protective benefits and is associated with a reduction in the incidence of invasive cervical cancer and cervical cancer mortality.

Defining publication bias: protocol for a systematic review of highly cited articles and proposal for a new framework

Katharina Müller — 2013-05-21T00:00:00Z

Background: Selective publication of studies, which is commonly called publication bias, is widely recognized. Over the years a new nomenclature for other types of bias related to non-publication or distortion related to the dissemination of research findings has been developed. However, several of these different biases are often still summarized by the term 'publication bias'.Methods/DesignAs part of the OPEN Project (To Overcome failure to Publish nEgative fiNdings) we will conduct a systematic review with the following objectives:- To systematically review highly cited articles that focus on non-publication of studies and to present the various definitions of biases related to the dissemination of research findings contained in the articles identified.- To develop and discuss a new framework on nomenclature of various aspects of distortion in the dissemination process that leads to public availability of research findings in an international group of experts in the context of the OPEN Project.We will systematically search Web of Knowledge for highly cited articles that provide a definition of biases related to the dissemination of research findings. A specifically designed data extraction form will be developed and pilot-tested. Working in teams of two, we will independently extract relevant information from each eligible article.For the development of a new framework we will construct an initial table listing different levels and different hazards en route to making research findings public. An international group of experts will iteratively review the table and reflect on its content until no new insights emerge and consensus has been reached.DiscussionResults are expected to be publicly available in mid-2013. This systematic review together with the results of other systematic reviews of the OPEN project will serve as a basis for the development of future policies and guidelines regarding the assessment and prevention of publication bias.

Systematic review and stratified meta-analysis of the efficacy of RhoA and Rho kinase inhibitors in animal models of ischaemic stroke

Hanna Vesterinen — 2013-05-20T00:00:00Z

Background: There is currently only one clinically approved drug, tissue plasminogen activator (tPA), for the treatment of acute ischaemic stroke. The RhoA pathway, including RhoA and its downstream effector Rho kinase (ROCK), has been identified as a possible therapeutic target. Our aim was to assess the impact of study design characteristics and study quality on reported measures of efficacy and to assess for the presence and impact of publication bias. Methods: We conducted a systematic review and meta-analysis on publications describing the efficacy of RhoA and ROCK inhibitors in animal models of focal cerebral ischaemia where outcome was assessed as a change in lesion size or neurobehavioural score, or both. Results: We identified 25 published papers which met our inclusion criteria. RhoA and ROCK inhibitors reduced lesion size by 37.3% in models of focal cerebral ischaemia (95% CI, 28.6% to 46.0%, 41 comparisons), and reduced neurobehavioural data by 40.5% (33.4% to 47.7%, 30 comparisons). Overall study quality was low (median=4, interquartile range 3–5) and measures to reduce bias were seldom reported. Publication bias was prevalent and associated with a substantial overstatement of efficacy for lesion size. Conclusions: RhoA and ROCK inhibitors appear to be effective in animal models of stroke. However the low quality score, publication bias and limited number of studies are areas which need attention prior to conducting clinical trials.