Publishing

Systematic reviews and meta-analyses are essential to summarize evidence relating to efficacy and safety of health care interventions accurately and reliably. The clarity and transparency of these reports, however, is not optimal. Poor reporting of systematic reviews diminishes their value to clinicians, policy makers, and other users. Since the development of the QUOROM (QUality Of Reporting Of Meta-analysis) Statement-a reporting guideline published in 1999-there have been several conceptual, methodological, and practical advances regarding the conduct and reporting of systematic reviews and meta-analyses. Also, reviews of published systematic reviews have found that key information about these studies is often poorly reported. Realizing these issues, an international group that included experienced authors and methodologists developed PRISMA (Preferred Reporting Items for Systematic reviews and Meta-Analyses) as an evolution of the original QUOROM guideline for systematic reviews and meta-analyses of evaluations of health care interventions. The PRISMA Statement consists of a 27-item checklist and a four-phase flow diagram. The checklist includes items deemed essential for transparent reporting of a systematic review. In this Explanation and Elaboration document, we explain the meaning and rationale for each checklist item. For each item, we include an example of good reporting and, where possible, references to relevant empirical studies and methodological literature. The PRISMA Statement, this document, and the associated Web site (www .prisma-statement.org) should be helpful resources to improve reporting of systematic reviews and meta-analyses.

Overwhelming evidence shows the quality of reporting of randomised controlled trials (RCTs) is not optimal. Without transparent reporting, readers cannot judge the reliability and validity of trial findings nor extract information for systematic reviews. Recent methodological analyses indicate that inadequate reporting and design are associated with biased estimates of treatment effects. Such systematic error is seriously damaging to RCTs, which are considered the gold standard for evaluating interventions because of their ability to minimise or avoid bias.

The PRISMA statement is a reporting guideline designed to improve the completeness of reporting of systematic reviews and meta-analyses. Authors have used this guideline worldwide to prepare their reviews for publication. In the past, these reports typically compared 2 treatment alternatives. With the evolution of systematic reviews that compare multiple treatments, some of them only indirectly, authors face novel challenges for conducting and reporting their reviews. This extension of the PRISMA (Preferred Reporting Items for Systematic Reviews and Meta-analyses) statement was developed specifically to improve the reporting of systematic reviews incorporating network meta-analyses. A group of experts participated in a systematic review, Delphi survey, and face-to-face discussion and consensus meeting to establish new checklist items for this extension statement. Current PRISMA items were also clarified. A modified, 32-item PRISMA extension checklist was developed to address what th...

The incidence rate of treated end-stage renal disease in the united states is 180 per million and continues to rise at a rate of 7.8% per year. Arteriovenous hemodialysis access (AV access) creation and maintenance are two of the most difficult issues associated with the management of patients on hemodialysis. The 1-year complication rate of a primary prosthetic AV access for hemodialysis ranges from 33% to 99%. Various investigators report on patency and complications of AV access. However, it is rather difficult to compare outcomes because of the wide variety of access materials, configurations, locations, risk factors, and quality of inflow and outflow vessels. Although there have been reporting standards for dialysis access endovascular interventions and for central venous access placement, standards regarding surgical access placement and its revision are lacking. The "Dialysis Outcome Quality Initiative," published by the National Kidney Foundation, provides recommendations for optimal clinical practices aimed at improving dialysis outcome and patient survival. This reporting standards document is not meant to be a "practice guidelines" or "best practices" document. Rather, the purpose of this document is to provide standardized definitions related to AV access procedures and to recommend reporting standards for patency and complications, to be used by surgeons, nephrologists, and interventional radiologists, that will permit meaningful comparisons among AV access procedures. The terms, definitions, and categories featured in this article have been approved by the Committee on Reporting Standards of the Society for Vascular Surgery and the American Association for Vascular Surgery and should be observed in preparing manuscripts on AV accesses for submission to the Journal Of Vascular Surgery.

Committee between 1984 and 1987, were studied for evidence of publication bias. As of May, 1990, 285 of the studies had been analysed by the investigators, and 52% of these had been published. Studies with statistically significant results were more likely to be published than those finding no difference between the study groups (adjusted odds ratio [OR] 2·32; 95% confidence interval [Cl] 1·25-4·28). Studies with significant results were also more likely to lead to a greater number of publications and presentations and to be published in journals with a high citation impact factor. An increased likelihood of publication was also associated with a high rating by the investigator of the importance of the study results, and with increasing sample size. The tendency towards publication bias was greater with observational and laboratory-based experimental studies (OR=3·79; 95% CI=1·47-9·76) than with randomised clinical trials (OR=0·84; 95% CI=0·34-2·09). We have confirmed the presence of publication bias in a cohort of clinical research studies. These findings suggest that conclusions based only on a review of published data should be interpreted cautiously, especially for observational studies. Improved strategies are needed to identify the results of unpublished as well as published studies.

An extra box per intervention group relating to care providers has been added. For cluster randomized, controlled trials, authors should refer to the appropriate extension. IQR ϭ interquartile range; max ϭ maximum; min ϭ minimum. Centers (n = 9) performing the intervention Number of patients treated by each center (median = 6 [IQR: 1-9]; min = 1, max = 64) Lost to follow-up (n = 0) Discontinued intervention Received stent (n = 45) Received second brachytherapy (n = 3) Lost to follow-up (n = 0) Discontinued intervention Received brachytherapy (n = 2) Received second stent treatment (n = 24) Analyzed (n = 101) Analyzed (n = 108)

Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Methods Medline searches were supplemented with material identified in the references and in the authors' personal files. Data were independently abstracted by three of the authors and disagreements were resolved by consensus.

Privacy is an important issue when one wants to make use of data that involves individuals' sensitive information. Research on protecting the privacy of individuals and the confidentiality of data has received contributions from many fields, including computer science, statistics, economics, and social science. In this paper, we survey research work in privacy-preserving data publishing. This is an area that attempts to answer the problem of how an organization, such as a hospital, government agency, or insurance company, can release data to the public without violating the confidentiality of personal information. We focus on privacy criteria that provide formal safety guarantees, present algorithms that sanitize data to make it safe for release while preserving useful information, and discuss ways of analyzing the sanitized data. Many challenges still remain. This survey provides a summary of the current state-of-the-art, based on which we expect to see advances in years to come.

A BSTRACT : In the past 15 years, we have seen a marked increase in research on socioeconomic status (SES) and health. Research in the first part of this era examined the nature of the relationship of SES and health, revealing a graded association; SES is important to health not only for those in poverty, but at all levels of SES. On average, the more advantaged individuals are, the better their health. In this paper we examine the data regarding the SES-health gradient, addressing causal direction, generalizability across populations and diseases, and associations with health for different indicators of SES. In the most recent era, researchers are increasingly exploring the mechanisms by which SES exerts an influence on health. There are multiple pathways by which SES determines health; a comprehensive analysis must include macroeconomic contexts and social factors as well as more immediate social environments, individual psychological and behavioral factors, and biological predispositions and processes.

Scientific communication is a misnomer. The process of scientific publication is much less a forum where information is exchanged for information than a market where information is exchanged for attention. Nevertheless, the exchange of information for attention is a somewhat peculiar market, since it seems much more natural to sell the information one has produced laboriously for money. Why publish a discovery, why share it with other researchers, when knowledge is power?

This article draws upon a paper originally presented at the 'Of the South' Symposium in July 2006. The author acknowledges the initiative taken in bringing together people from across the 'South' to participate in an important dialogue on the meaning and nuances of existence in the 'South'. The two questions at the start of this article acted as the guiding themes for the symposium participants to address.

The US National Institute of Neurological Disorders and Stroke convened major stakeholders in June 2012 to discuss how to improve the methodological reporting of animal studies in grant applications and publications. The main workshop recommendation is that at a minimum studies should report on sample-size estimation, whether and how animals were randomized, whether investigators were blind to the treatment, and the handling of data. We recognize that achieving a meaningful improvement in the quality of reporting will require a concerted effort by investigators, reviewers, funding agencies and journal editors. Requiring better reporting of animal studies will raise awareness of the importance of rigorous study design to accelerate scientific progress.

Background Questions concerning the safety of selective serotonin reuptake inhibitors (SSRIs) in the treatment of depression in children led us to compare and contrast published and unpublished data on the risks and benefits of these drugs. Methods We did a meta-analysis of data from randomised controlled trials that evaluated an SSRI versus placebo in participants aged 5-18 years and that were published in a peer-reviewed journal or were unpublished and included in a review by the Committee on Safety of Medicines. The following outcomes were included: remission, response to treatment, depressive symptom scores, serious adverse events, suicide-related behaviours, and discontinuation of treatment because of adverse events. Findings Data for two published trials suggest that fluoxetine has a favourable risk-benefit profile, and unpublished data lend support to this finding. Published results from one trial of paroxetine and two trials of sertraline suggest equivocal or weak positive risk-benefit profiles. However, in both cases, addition of unpublished data indicates that risks outweigh benefits. Data from unpublished trials of citalopram and venlafaxine show unfavourable risk-benefit profiles. Interpretation Published data suggest a favourable riskbenefit profile for some SSRIs; however, addition of unpublished data indicates that risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people. Clinical guideline development and clinical decisions about treatment are largely dependent on an evidence base published in peerreviewed journals. Non-publication of trials, for whatever reason, or the omission of important data from published trials, can lead to erroneous recommendations for treatment. Greater openness and transparency with respect to all intervention studies is needed.

Agents in creative enterprises are embedded in networks that inspire, support, and evaluate their work. Here, we investigate how the mechanisms by which creative teams self-assemble determine the structure of these collaboration networks. We propose a model for the self-assembly of creative teams that is based on three parameters: team size, the fraction of newcomers in new productions and the tendency of incumbents to repeat previous collaborations. The model suggests that the emergence of a large connected community of practitioners can be described as a phase transition. We find that team assembly mechanisms determine both the structure of the collaboration network and team performance, for teams derived from both artistic and scientific fields. Teams are assembled because of the need to incorporate individuals with different ideas, skills, and resources. Creativity is spurred when proved innovations in one domain are intro

This article is seeking to explore the practical implications of an epistemological approach to strategy formulation. In doing so it tries to expand the field of knowledge management and intellectual capital beyond its operational and often inwardly technological focus to a new theory of the firm. A resource-based perspective is suggested, using autopoietic epistemology to guide strategy formulation. People use their capacity-to-act in order to create value in mainly two directions; by transferring and converting knowledge externally and internally to the organisation. The value grows each time a knowledge transfer or conversion takes place. The strategy formulation issues are concerned with how to utilise the leverage and how to avoid the blockages that prevent sharing and conversion. Activities that form the backbone of a knowledge-based strategy are to be aimed at improving the capacity-to-act both inside and outside the organisation.

Background A recent review suggested an association between using unpublished scales in clinical trials and finding significant results. Aims To determine whether such an association existed in schizophrenia trials. Method Three hundred trials were randomly selected from the Cochrane Schizophrenia Group's Register. All comparisons between treatment groups and control groups using rating scales were identified. The publication status of each scale was determined and claims of a significant treatment effect were recorded. Results Trials were more likely to report that a treatment was superior to control when an unpublished scale was used to make the comparison (relative risk 1.37 (95% C11.12–1.68)). This effect increased when a ‘gold-standard’ definition of treatment superiority was applied (RR 1.94 (95% C11.35–2.79)). In non-pharmacological trials, one-third of ‘gold-standard’ claims of treatment superiority would not have been made if published scales had been used. Conclusions ...

Evaluating the variation in the strength of the effect across studies is a key feature of metaanalyses. This variability is reflected by measures like τ 2 or I 2 , but their clinical interpretation is not straightforward. A prediction interval is less complicated: it presents the expected range of true effects in similar studies. We aimed to show the advantages of having the prediction interval routinely reported in meta-analyses. Design: We show how the prediction interval can help understand the uncertainty about whether an intervention works or not. To evaluate the implications of using this interval to interpret the results, we selected the first meta-analysis per intervention review of the Cochrane Database of Systematic Reviews Issues 2009-2013 with a dichotomous (n=2009) or continuous (n=1254) outcome, and generated 95% prediction intervals for them. Results: In 72.4% of 479 statistically significant (random-effects p<0.05) meta-analyses in the Cochrane Database 2009-2013 with heterogeneity (I 2 >0), the 95% prediction interval suggested that the intervention effect could be null or even be in the opposite direction. In 20.3% of those 479 meta-analyses, the prediction interval showed that the effect could be completely opposite to the point estimate of the meta-analysis. We demonstrate also how the prediction interval can be used to calculate the probability that a new trial will show a negative effect and to improve the calculations of the power of a new trial. Conclusions: The prediction interval reflects the variation in treatment effects over different settings, including what effect is to be expected in future patients, such as the patients that a clinician is interested to treat. Prediction intervals should be routinely reported to allow more informative inferences in meta-analyses.

Mathematical modeling of watershed hydrology is employed to address a wide spectrum of environmental and water resources problems. A historical perspective of hydrologic modeling is provided, and new developments and challenges in watershed models are discussed. These include data acquisition by remote sensing and space technology, digital terrain and elevation models, chemical tracers, geographic information and data management systems, topographic representation, upscaling of hydrologic conservation equations, spatial variability of hydraulic roughness, infiltration and precipitation, spatial and temporal scaling, model calibration, and linking with water quality models. Model construction, calibration, and data processing have received a great deal of attention, while model validation, error propagation, and analyses of uncertainty, risk, and reliability have not been treated as thoroughly. Finally, some remarks are made regarding the future outlook for watershed hydrology modeling.

The objective of this study was to assess the validity of an index of the scientific quality of research overviews, the Overview Quality Assessment Questionnaire (OQAQ). Thirty-six published review articles were assessed by 9 judges using the OQAQ. Authors reports of what they had done were compared to OQAQ ratings. The sensibility of the OQAQ was assessed using a 13 item questionnaire. Seven a priori hypotheses were used to assess construct validity. The review articles were drawn from three sampling frames: articles highly rated by criteria external to the study, meta-analyses, and a broad spectrum of medical journals. Three categories of judges were used to assess the articles: research assistants, clinicians with research training and experts in research methodology, with 3 judges in each category. The sensibility of the index was assessed by 15 randomly selected faculty members of the Department of Clinical Epidemiology and Biostatistics at McMaster. Authors' reports of their methods related closely to ratings from corresponding OQAQ items: for each criterion, the mean score was significantly higher for articles for which the authors responses indicated that they had used more rigorous methods. For 10 of the 13 questions used to assess sensibility the mean rating was 5 or greater, indicating general satisfaction with the instrument. The primary shortcoming noted was the need for judgement in applying the index. Six of the 7 hypotheses used to test construct validity held true. The OQAQ is a valid measure of the quality of research overviews.

Reconceptualising rigour: the case for re¯exivity This paper is a critical review of recent discussions of rigour in nursing research. We will argue that`borrowing' evaluation criteria from one paradigm of inquiry and applying them to another is problematic. We attempt to map the`rigour' ®eld and add a dimension to the existing debate about rigour and qualitative research through inclusion of re¯exivity guided by philosophical hermeneutics. We describe re¯exivity and appeal to writers to incorporate a re¯exive account into their research product by signposting to readers`what is going on' while researching. We contend that researchers bring to the research product, data generated, a range of literature, a positioning of this literature, a positioning of oneself, and moral socio-political contexts. We suggest that re¯exive research is characterized by ongoing self-critique and self-appraisal and that the research product can be given shape by the politics of location and positioning. We emphasize that in the creation of a text (the research product) it is desirable that the researcher be a skilled writer. Finally we claim that if the research product is well signposted, the readers will be able to travel easily through the worlds of the participants and makers of the text (the researchers) and decide for themselves whether the text is believable or plausible (our terms for rigour).

BackgroundThere is growing interest in realist synthesis as an alternative systematic review method. This approach offers the potential to expand the knowledge base in policy-relevant areas – for example, by explaining the success, failure or mixed fortunes of complex interventions. No previous publication standards exist for reporting realist syntheses. This standard was developed as part of the RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) project. The project's aim is to produce preliminary publication standards for realist systematic reviews.There is growing interest in realist synthesis as an alternative systematic review method. This approach offers the potential to expand the knowledge base in policy-relevant areas – for example, by explaining the success, failure or mixed fortunes of complex interventions. No previous publication standards exist for reporting realist syntheses. This standard was developed as part of the RAMESES (Realist And MEta-narrative Evidence Syntheses: Evolving Standards) project. The project's aim is to produce preliminary publication standards for realist systematic reviews.DesignA mixed method study synthesising data between 2011–2012 from a literature review, online Delphi panel and feedback from training, workshops and email list.A mixed method study synthesising data between 2011–2012 from a literature review, online Delphi panel and feedback from training, workshops and email list.MethodsWe: (a) collated and summarized existing literature on the principles of good practice in realist syntheses; (b) considered the extent to which these principles had been followed by published syntheses, thereby identifying how rigour may be lost and how existing methods could be improved; (c) used a three-round online Delphi method with an interdisciplinary panel of national and international experts in evidence synthesis, realist research, policy and/or publishing to produce and iteratively refine a draft set of methodological steps and publication standards; (d) provided real-time support to ongoing realist syntheses and the open-access RAMESES online discussion list to capture problems and questions as they arose; and (e) synthesized expert input, evidence syntheses and real-time problem analysis into a definitive set of standards.We: (a) collated and summarized existing literature on the principles of good practice in realist syntheses; (b) considered the extent to which these principles had been followed by published syntheses, thereby identifying how rigour may be lost and how existing methods could be improved; (c) used a three-round online Delphi method with an interdisciplinary panel of national and international experts in evidence synthesis, realist research, policy and/or publishing to produce and iteratively refine a draft set of methodological steps and publication standards; (d) provided real-time support to ongoing realist syntheses and the open-access RAMESES online discussion list to capture problems and questions as they arose; and (e) synthesized expert input, evidence syntheses and real-time problem analysis into a definitive set of standards.ResultsWe identified 35 published realist syntheses, provided real-time support to 9 ongoing syntheses and captured questions raised in the RAMESES discussion list. Through analysis and discussion within the project team, we summarized the published literature and common questions and challenges into briefing materials for the Delphi panel, comprising 37 members. Within 3 rounds this panel had reached consensus on 19 key publication standards, with an overall response rate of 91%.We identified 35 published realist syntheses, provided real-time support to 9 ongoing syntheses and captured questions raised in the RAMESES discussion list. Through analysis and discussion within the project team, we summarized the published literature and common questions and challenges into briefing materials for the Delphi panel, comprising 37 members. Within 3 rounds this panel had reached consensus on 19 key publication standards, with an overall response rate of 91%.ConclusionsThis project used multiple sources to develop and draw together evidence and expertise in realist synthesis. For each item we have included an explanation for why it is important and guidance on how it might be reported. Realist synthesis is a relatively new method for evidence synthesis and as experience and methodological developments occur, we anticipate that these standards will evolve to reflect further methodological developments. We hope that these standards will act as a resource that will contribute to improving the reporting of realist syntheses.This project used multiple sources to develop and draw together evidence and expertise in realist synthesis. For each item we have included an explanation for why it is important and guidance on how it might be reported. Realist synthesis is a relatively new method for evidence synthesis and as experience and methodological developments occur, we anticipate that these standards will evolve to reflect further methodological developments. We hope that these standards will act as a resource that will contribute to improving the reporting of realist syntheses.

Open access (OA) to the research literature has the potential to accelerate recognition and dissemination of research findings, but its actual effects are controversial. This was a longitudinal bibliometric analysis of a cohort of OA and non-OA