610 research outputs found
What do the JAMA editors say when they discuss manuscripts that they are considering for publication? Developing a schema for classifying the content of editorial discussion
<p>Abstract</p> <p>Background</p> <p>In an effort to identify previously unrecognized aspects of editorial decision-making, we explored the words and phrases that one group of editors used during their meetings.</p> <p>Methods</p> <p>We performed an observational study of discussions at manuscript meetings at <it>JAMA</it>, a major US general medical journal. One of us (KD) attended 12 editorial meetings in 2003 as a visitor and took notes recording phrases from discussion surrounding 102 manuscripts. In addition, editors attending the meetings completed a form for each manuscript considered, listing the reasons they were inclined to proceed to the next step in publication and reasons they were not (DR attended 4/12 meetings). We entered the spoken and written phrases into NVivo 2.0. We then developed a schema for classifying the editors' phrases, using an iterative approach.</p> <p>Results</p> <p>Our classification schema has three main themes: science, journalism, and writing. We considered 2,463 phrases, of which 87 related mainly to the manuscript topic and were not classified (total 2,376 classified). Phrases related to science predominated (1,274 or 54%). The editors, most of whom were physicians, also placed major weight on goals important to JAMA's mission (journalism goals) such as importance to medicine, strategic emphasis for the journal, interest to the readership, and results (729 or 31% of phrases). About 16% (n = 373) of the phrases used related to writing issues, such as clarity and responses to the referees' comments.</p> <p>Conclusion</p> <p>Classification of editorial discourse provides insight into editorial decision making and concepts that need exploration in future studies.</p
Following 411 Cochrane Protocols to Completion: A Retrospective Cohort Study
Cochrane reviews are regarded as being scientifically rigorous and are increasingly used by a variety of stakeholders. However, factors predicting the publication of Cochrane reviews have never been reported. This is important because if a higher proportion of Cochrane protocols with certain characteristics (e.g., funding) are being published, this may lead to inaccurate decisions. We examined the frequency of published and unpublished Cochrane reviews and protocol factors that predict the publication of Cochrane reviews.Retrospective cohort study of Cochrane protocols published in 2000 (Issues 2 to 4) and 2001 (Issue 1). The publication status of these reviews was followed up to Issue 1, 2008 in The Cochrane Library. Survival analysis of the time from protocol publication to the first review publication and protocol factors predicting the time to publication was conducted. There were 411 new Cochrane protocols in the cohort. After excluding 39; 71/372 (19.1%) were unpublished and 301/372 (80.9%) were published as full Cochrane reviews at the time of study analysis (January 2008). The median time to publication was 2.4 years (range: 0.15 to 8.96). Multivariate analyses revealed that shorter time to publication was associated with the review subsequently being updated (hazard ratio, HR: 1.80 [95% confidence interval, CI: 1.39 to 2.33 years]) and longer time to publication was associated with the review having two published protocols, indicating changes to the review plan (HR: 0.33 [95% CI: 0.12 to 0.90 years]).Only about 80% Cochrane protocols were published as full reviews after over 8 years of follow-up. The median time to publication was 2.4 years and some reviews took much longer. Strategies to decrease time to publication should be considered, such as streamlining the review process, increased support for authors when protocol amendments occur, and better infrastructure for updating Cochrane reviews
Country development and manuscript selection bias: a review of published studies
BACKGROUND: Manuscript selection bias is the selective publication of manuscripts based on study characteristics other than quality indicators. One reason may be a perceived editorial bias against the researches from less-developed world. We aimed to compare the methodological quality and statistical appeal of trials from countries with different development status and to determine their association with the journal impact factors and language of publication. METHODS: Selection criteria: Based on the World Bank income criteria countries were divided into four groups. All records of clinical trials conducted in each income group during 1993 and 2003 were included if they contained abstract and study sample size. Data sources: Cochrane Controlled Trials Register was searched and 50 articles selected from each income group using a systematic random sampling method in years 1993 and 2003 separately. Data extraction: Data were extracted by two reviewers on the language of publication, use of randomization, blinding, intention to treat analysis, study sample size and statistical significance. Disagreement was dealt with by consensus. Journal impact factors were obtained from the institute for scientific information. RESULTS: Four hundred records were explored. Country income had an inverse linear association with the presence of randomization (chi2 for trend = 5.6, p = 0.02) and a direct association with the use of blinding (chi2 for trend = 6.9, p = 0.008); although in low income countries the probability of blinding was increased from 36% in 1993 to 46% in 2003. In 1993 the results of 68% of high income trials and 64.7% of other groups were statistically significant; but in 2003 they were 66% and 82% respectively. Study sample size and income were the only significant predictors of journal impact factor. CONCLUSION: The impact of country development on manuscript selection bias is considerable and may be increasing over time. It seems that one reason may be more stringent implementation of the guidelines for improving the reporting quality of trials on developing world researchers. Another reason may be the presumptions of the researchers from developing world about the editorial bias against their nationality
Are manufacturers sharing data as promised?
Over the past two years drug and device manufacturers have been among the most vocal contributors to the discussion about transparency of clinical trial data. In 2013 GlaxoSmithKline (GSK) established its Clinical Study Data Request system to share participant level data, and now 11 other companies are listed as contributors to it (www.clinicalstudydatarequest.com). Other companies have developed similar systems of their own,but it is difficult to evaluate how they are working or even to decide on what basis they should be judged
Effectiveness of different databases in identifying studies for systematic reviews: experience from the WHO systematic review of maternal morbidity and mortality
BACKGROUND: Failure to be comprehensive can distort the results of a systematic review. Conversely, extensive searches may yield unmanageable number of citations of which only few may be relevant. Knowledge of usefulness of each source of information may help to tailor search strategies in systematic reviews. METHODS: We conducted a systematic review of prevalence/incidence of maternal mortality and morbidities from 1997 to 2002. The search strategy included electronic databases, hand searching, screening of reference lists, congress abstract books, contacting experts active in the field and web sites from less developed countries. We evaluated the effectiveness of each source of data and discuss limitations and implications for future research on this topic. RESULTS: Electronic databases identified 64098 different citations of which 2093 were included. Additionally 487 citations were included from other sources. MEDLINE had the highest yield identifying about 62% of the included citations. BIOSIS was the most precise with 13.2% of screened citations included. Considering electronic citations alone (2093), almost 20% were identified uniquely by MEDLINE (400), 7.4% uniquely by EMBASE (154), and 5.6% uniquely by LILACS (117). About 60% of the electronic citations included were identified by two or more databases. CONCLUSIONS: This analysis confirms the need for extending the search to other sources beyond well-known electronic databases in systematic reviews of maternal mortality and morbidity prevalence/incidence. These include regional databases such as LILACS and other topic specific sources such as hand searching of relevant journals not indexed in electronic databases. Guidelines for search strategies for prevalence/incidence studies need to be developed
Impact of funding on biomedical research: a retrospective cohort study
BACKGROUND: Public funding is aimed at facilitating the initiation, completion and publication of research study protocols. However, no evaluation is made to investigate the impact of grant success on the conduct of biomedical research. It is therefore of great interest to compare the fate of funded protocols versus not funded: Are they initiated? Are they completed? Did the results confirm the hypothesis? Were they published? The objective was to investigate the fate of protocols submitted for funding, whether they were funded or not. METHODS: Retrospective cohort study of protocols submitted for funding to the Greater Lyon regional scientific committee in 1997. Initial characteristics of protocols (design, study size, investigator status) were abstracted from archives, and follow-up characteristics (initiation, completion and publication) from a mailed questionnaire to the principal investigators. RESULTS: Among the 142 submitted protocols, follow-up information was available for 114 (80%). As a whole, 38% of studies were funded by the Greater Lyon research committee. The rate of initiation varied from 62% for studies with no acknowledged funding to 100% for studies with both committee and other simultaneous funding. When initiated, the rate of completion was 62% for studies with at least one funding and 40% for studies without acknowledged funding. When completed, publication was reached for 77% of studies with either committee or external funding, for 58% of studies without acknowledged funding and for 37% of studies with both committee and external funding. CONCLUSION: Some protocols submitted for funding were initiated and completed without any funding declared. To our understanding this mean that not all protocols submitted really needed funding and also that health care facilities are unaware that they implicitly financially support and pay for biomedical research
Open Science in Software Engineering
Open science describes the movement of making any research artefact available
to the public and includes, but is not limited to, open access, open data, and
open source. While open science is becoming generally accepted as a norm in
other scientific disciplines, in software engineering, we are still struggling
in adapting open science to the particularities of our discipline, rendering
progress in our scientific community cumbersome. In this chapter, we reflect
upon the essentials in open science for software engineering including what
open science is, why we should engage in it, and how we should do it. We
particularly draw from our experiences made as conference chairs implementing
open science initiatives and as researchers actively engaging in open science
to critically discuss challenges and pitfalls, and to address more advanced
topics such as how and under which conditions to share preprints, what
infrastructure and licence model to cover, or how do it within the limitations
of different reviewing models, such as double-blind reviewing. Our hope is to
help establishing a common ground and to contribute to make open science a norm
also in software engineering.Comment: Camera-Ready Version of a Chapter published in the book on
Contemporary Empirical Methods in Software Engineering; fixed layout issue
with side-note
Trial Publication after Registration in ClinicalTrials.Gov: A Cross-Sectional Analysis
Joseph Ross and colleagues examine publication rates of clinical trials and find low rates of publication even following registration in Clinicaltrials.gov
Publication Delay of Randomized Trials on 2009 Influenza A (H1N1) Vaccination
Background: Randomized evidence for vaccine immunogenicity and safety is urgently needed in the setting of pandemics with new emerging infectious agents. We carried out an observational survey to evaluate how many randomized controlled trials testing 2009 H1N1 vaccines were published among those registered, and what was the time lag from their start to publication and from their completion to publication. Methods: PubMed, EMBASE and 9 clinical trial registries were searched for eligible randomized controlled trials. The units of the analysis were single randomized trials on any individual receiving influenza vaccines in any setting. Results: 73 eligible trials were identified that had been registered in 2009–2010. By June 30, 2011 only 21 (29%) of these trials had been published, representing 38 % of the randomized sample size (19905 of 52765). Trials starting later were published less rapidly (hazard ratio 0.42 per month; 95 % Confidence Interval: 0.27 to 0.64; p,0.001). Similarly, trials completed later were published less rapidly (hazard ratio 0.43 per month; 95 % CI: 0.27 to 0.67; p,0.001). Randomized controlled trials were completed promptly (median, 5 months from start to completion), but only a minority were subsequently published. Conclusions: Most registered randomized trials on vaccines for the H1N1 pandemic are not published in the peer-reviewe
Searching for observational studies: what does citation tracking add to PubMed? A case study in depression and coronary heart disease
BACKGROUND: PubMed is the most widely used method for searches of the medical literature, but fails to identify many relevant articles. Electronic citation tracking offers an alternative search method. METHODS: Articles investigating the role of depression in the aetiology and prognosis of coronary heart disease were sought through two methods: a) PubMed, and b) citation tracking where Science Citation Index was searched for all articles which cited ("forward citation tracking") or were cited by ("backward citation tracking") any of the articles in an index review. The number and quality of eligible articles identified by the two methods were compared. RESULTS: 50 articles that were not already included in the index review met our inclusion criteria; 11 were identified through Science Citation Index alone, 8 through PubMed alone, and 31 through both methods. Articles identified by Science Citation Index alone were published in higher impact factor journals, were larger and were less likely to show a positive association. CONCLUSION: Science Citation Index identified more eligible articles than PubMed, and these differed qualitatively. Failing to use citation tracking in a systematic review of observational studies may result in bias
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