PMCC PMCC

Search tips
Search criteria

Advanced
Results 1-25 (491343)

Clipboard (0)
None

Related Articles

1.  Peer review comments on drug trials submitted to medical journals differ depending on sponsorship, results and acceptance: a retrospective cohort study 
BMJ Open  2015;5(9):e007961.
Objective
During peer review, submitted manuscripts are scrutinised by independent experts to assist journal editors in their decision-making and to help improve the quality of articles. In this retrospective cohort study, peer review comments for drug trials submitted to medical journals were analysed to investigate whether there is a relation between the content of these comments and sponsorship, direction of results and decision about acceptance.
Design/setting
Descriptive content analysis of reviewer comments made on manuscripts on drug trials submitted to eight medical journals (January 2010–April 2012). For each manuscript, the number of reviewers, decision about acceptance, sponsorship and direction of results were extracted. Reviewer comments were classified using a predefined checklist.
Results
Reviewer reports for 246 manuscripts were assessed. Industry-sponsored trials were more likely to receive comments about lack of novelty (8.9%) than industry-supported (2.5%) and non-industry trials (6.1%, overall p=0.038). Non-industry trials more often received comments about poor experimental design (69.7%) than industry-supported (58.8%) and industry-sponsored trials (52.9%, overall p=0.019). Non-industry trials were also more likely to receive comments regarding inappropriate statistical analyses (28.4%) than industry-supported (23.5%) and industry-sponsored trials (15.1%, overall p=0.006). Manuscripts with negative results were more likely to receive comments about inappropriate conclusions (29.3%) than those with positive results (18.9%, p=0.010). Rejected manuscripts had more often received comments on the research question not being clinically relevant (7.8%) than accepted manuscripts (1.6%, p=0.002), and also on lack of novelty (8.3% vs 2.6%, p=0.008) and poor experimental design (68.6% vs 50.5%, p<0.001).
Conclusions
Reviewers identified fewer shortcomings regarding design and statistical analyses in industry-related trials, but commented more often on a lack of novelty in industry-sponsored trials. Negative trial results did not significantly influence the nature of comments other than appropriateness of the conclusion. Manuscript acceptance was primarily related to the research question and methodological robustness of studies.
doi:10.1136/bmjopen-2015-007961
PMCID: PMC4593154  PMID: 26423849
EPIDEMIOLOGY; STATISTICS & RESEARCH METHODS
2.  Ghost Authorship in Industry-Initiated Randomised Trials 
PLoS Medicine  2007;4(1):e19.
Background
Ghost authorship, the failure to name, as an author, an individual who has made substantial contributions to an article, may result in lack of accountability. The prevalence and nature of ghost authorship in industry-initiated randomised trials is not known.
Methods and Findings
We conducted a cohort study comparing protocols and corresponding publications for industry-initiated trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg in 1994–1995. We defined ghost authorship as present if individuals who wrote the trial protocol, performed the statistical analyses, or wrote the manuscript, were not listed as authors of the publication, or as members of a study group or writing committee, or in an acknowledgment. We identified 44 industry-initiated trials. We did not find any trial protocol or publication that stated explicitly that the clinical study report or the manuscript was to be written or was written by the clinical investigators, and none of the protocols stated that clinical investigators were to be involved with data analysis. We found evidence of ghost authorship for 33 trials (75%; 95% confidence interval 60%–87%). The prevalence of ghost authorship was increased to 91% (40 of 44 articles; 95% confidence interval 78%–98%) when we included cases where a person qualifying for authorship was acknowledged rather than appearing as an author. In 31 trials, the ghost authors we identified were statisticians. It is likely that we have overlooked some ghost authors, as we had very limited information to identify the possible omission of other individuals who would have qualified as authors.
Conclusions
Ghost authorship in industry-initiated trials is very common. Its prevalence could be considerably reduced, and transparency improved, if existing guidelines were followed, and if protocols were publicly available.
Of 44 industry-initiated trials, there was evidence of ghost authorship in 33, increasing to 40 when a person qualifying for authorship was acknowledged rather than appearing as an author.
Editors' Summary
Background.
Original scientific findings are usually published in the form of a “paper”, whether it is actually distributed on paper, or circulated via the internet, as this one is. Papers are normally prepared by a group of researchers who did the research and are then listed at the top of the article. These authors therefore take responsibility for the integrity of the results and interpretation of them. However, many people are worried that sometimes the author list on the paper does not tell the true story of who was involved. In particular, for clinical research, case histories and previous research has suggested that “ghost authorship” is commonplace. Ghost authors are people who were involved in some way in the research study, or writing the paper, but who have been left off the final author list. This might happen because the study “looks” more credible if the true authors (for example, company employees or freelance medical writers) are not revealed. This practice might hide competing interests that readers should be aware of, and has therefore been condemned by academics, groups of editors, and some pharmaceutical companies.
Why Was This Study Done?
This group of researchers wanted to get an idea of how often ghost authorship happened in medical research done by companies. Previous studies looking into this used surveys, whereby the researchers would write to one author on each of a group of papers to ask whether anyone else had been involved in the work but who was not listed on the paper. These sorts of studies typically underestimate the rate of ghost authorship, because the main author might not want to admit what had been going on. However, the researchers here managed to get access to trial protocols (documents setting out the plans for future research studies), which gave them a way to investigate ghost authorship.
What Did the Researchers Do and Find?
In order to investigate the frequency and type of ghost authorship, these researchers identified every trial which was approved between 1994 and 1995 by the ethics committees of Copenhagen and Frederiksberg in Denmark. Then they winnowed this group down to include only the trials that were sponsored by industry (pharmaceutical companies and others), and only those trials that were finished and published. The protocols for each trial were obtained from the ethics committees and the researchers then matched up each protocol with its corresponding paper. Then, they compared names which appeared in the protocol against names appearing on the eventual paper, either on the author list or acknowledged elsewhere in the paper as being involved. The researchers ended up studying 44 trials. For 31 of these (75% of them) they found some evidence of ghost authorship, in that people were identified as having written the protocol or who had been involved in doing statistical analyses or writing the manuscript, but did not end up listed in the manuscript. If the definition of authorship was made narrower, and “ghost authorship” included people qualifying for authorship who were mentioned in the acknowledgements but not the author list, the researchers' estimate went up to 91%, that is 40 of the 44 trials. For most of the trials with missing authors, the ghost was a statistician (the person who analyzes the trial data).
What Do These Findings Mean?
In this study, the researchers found that ghost authorship was very common in papers published in medical journals (this study covered a broad range of peer-reviewed journals in many medical disciplines). The method used in this paper seems more reliable than using surveys to work out how often ghost authorship happens. The researchers aimed to define authorship using the policies set out by a group called the International Committee of Medical Journal Editors (ICMJE), and the findings here suggest that the ICMJE's standards for authorship are very often ignored. This means that people who read the published paper cannot always accurately judge or trust the information presented within it, and competing interests may be hidden. The researchers here suggest that protocols should be made publicly available so that everyone can see what trials are planned and who is involved in conducting them. The findings also suggest that journals should not only list the authors of each paper but describe what each author has done, so that the published information accurately reflects what has been carried out.
Additional Information.
Please access these Web sites via the online version of this summary at http://dx.doi.org/10.1371/journal.pmed.0040019.
Read the Perspective by Liz Wager, which discusses these findings in more depth
The International Committee of Medical Journal Editors (ICMJE) is a group of general medical journal editors who have produced general guidelines for biomedical manuscripts; their definition of authorship is also described
The Committee on Publication Ethics is a forum for editors of peer-reviewed journals to discuss issues related to the integrity of the scientific record; the Web site lists anonymized problems and the committee's advice, not just regarding authorship, but other types of problems as well
Good Publication Practice for Pharmaceutical Companies outlines common standards for publication of industry-sponsored medical research, and some pharmaceutical companies have agreed to these
doi:10.1371/journal.pmed.0040019
PMCID: PMC1769411  PMID: 17227134
3.  Public Commenting on Inpatient Psychiatry Smoking Ban Media Coverage 
Journal of dual diagnosis  2014;10(4):204-211.
Objective
Individuals with mental health concerns are disproportionately affected by, and suffer the negative consequences of, tobacco use disorder, perhaps because smoking has historically been part of psychiatry’s culture. In the early 1990s, psychiatric inpatient facilities were exempted from US hospital smoking bans, in response to public outcries with national media attention. Almost two decades later, the current study characterizes online conversation about psychiatric hospital smoking bans. Previous commenting studies have demonstrated commenting’s negativity, documenting the “nasty effect” wherein negative comments color perceptions of neutral articles. Thus, we focused particular attention on cited barriers to implementing health-positive smokefree policies.
Methods
We collected online comments (N=261) responding to popular media articles on smoking bans in inpatient psychiatry between 2013 and 2014, and conducted an inductive and exploratory qualitative content analysis.
Results
Verifying previous studies documenting the prevalence of negative commenting, of the comments explicitly supporting or refuting psychiatry smoking bans, there were over twice as many con comments (44) than pro (18). Many commenters argued for access to outdoor smoking areas and warned of patient agitation and risk posed to care workers. Identified content themes included psychiatric medication and negative side effects, broken mental health systems and institutions, denigration of the health risks of tobacco in the context of mental illness, typical pro-smoking arguments about “smokers’ rights” and alternatives (including e-cigarettes), addiction, and stigma.
Conclusions
The current findings provide a platform to begin to understand how people talk about mental health issues and smoking. Our analysis also raised complex issues concerning forces that impact US patients with serious mental illness, but over which they have little control, including medication, the US health system, stigma, perceptions that life with chronic serious mental illness is not worth living, and psychological and physical pain of coping with mental illness. In consideration of identified barriers raised in opposition to smoking bans in inpatient psychiatry, efforts should emphasize patient stakeholder involvement; patient, visitor, and staff protection from smoke exposure; the effectiveness of nicotine replacement for managing withdrawal; and the lack of evidence that cigarettes are therapeutic.
doi:10.1080/15504263.2014.961883
PMCID: PMC4408924  PMID: 25391278
smoking ban; psychiatric inpatient; schizophrenia; stigma
4.  The relationship between manuscript title structure and success: editorial decisions and citation performance for an ecological journal 
Ecology and Evolution  2015;5(10):1970-1980.
A poorly chosen article title may make a paper difficult to discover or discourage readership when discovered, reducing an article's impact. Yet, it is unclear how the structure of a manuscript's title influences readership and impact. We used manuscript tracking data for all manuscripts submitted to the journal Functional Ecology from 2004 to 2013 and citation data for papers published in this journal from 1987 to 2011 to examine how title features changed and whether a manuscript's title structure was predictive of success during the manuscript review process and/or impact (citation) after publication. Titles of manuscripts submitted to Functional Ecology became marginally longer (after controlling for other variables), broader in focus (less frequent inclusion of genus and species names), and included more humor and subtitles over the period of the study. Papers with subtitles were less likely to be rejected by editors both pre- and post-peer review, although both effects were small and the presence of subtitles in published papers was not predictive of citations. Papers with specific names of study organisms in their titles fared poorly during editorial (but not peer) review and, if published, were less well cited than papers whose titles did not include specific names. Papers with intermediate length titles were more successful during editorial review, although the effect was small and title word count was not predictive of citations. No features of titles were predictive of reviewer willingness to review papers or the length of time a paper was in peer review. We conclude that titles have changed in structure over time, but features of title structure have only small or no relationship with success during editorial review and post-publication impact. The title feature that was most predictive of manuscript success: papers whose titles emphasize broader conceptual or comparative issues fare better both pre- and post-publication than do papers with organism-specific titles.
doi:10.1002/ece3.1480
PMCID: PMC4449752  PMID: 26045949
Citation analysis; editorial review; Functional Ecology; peer review; writing style
5.  Electronic Submission of Academic Works: A Survey of Current Editorial Practices of Radiologic Journals  
Journal of Digital Imaging  2001;14(2):107-110.
Computers are nearly ubiquitous in academic medicine, and authors create and compile much of their work in the electronic environment, yet the process of manuscript submission often fails to utilize the advantages of electronic communication. The purpose of this report is to review the submission policies of major academic journals in the field of radiology and assess current editorial practices relating to electronic submission of academic works. The authors surveyed 16 radiologic journals that are indexed in the Index Medicus and available in our medical center library. They compared the manuscript submission policies of these journals as outlined in recent issues of the journals and the corresponding worldwide web sites. The authors compared the journals on the following criteria: web site access to instructions; electronic submission of text, both with regard to initial submission and final submission of the approved document; text hardcopy requirements; word processing software restrictions; electronic submission of figures, figure hardcopy requirements; figure file format restrictions; and electronic submission media. Although the trend seems to be toward electronic submission, there currently is no clear-cut standard of practice. Because all of the journals that accept electronic documents also require a hardcopy, many of the advantages gained through electronic submission are nullified. In addition, many publishers only utilize electronic documents after a manuscript has been accepted, thus utilizing the benefits of digital information in the printing process but not in the actual submission and peer-review process.
doi:10.1007/s10278-001-0008-x
PMCID: PMC3452756  PMID: 11440253
6.  How to respond to referee comments for scientific articles? 
Turkish journal of urology  2013;39(Suppl 1):33-36.
Currently, the increasing number of article submissions to scientific journals forces editors to be more selective in their acceptance of papers. Consequently, editors have increased the frequency of their use of scientific referee mechanisms. For many researchers, the publication of a scientific article in a high impact factor journal is a gradual and difficult process. After preparation and submission of a manuscript, one of the most important issue is responding to the comments of referees. However, there is a paucity of published reports in the literature describing how to respond to these comments. The aim of this review is to assist researchers/authors in responding to referee comments as part of the publication process for scientific articles.
doi:10.5152/tud.2013.051
PMCID: PMC4548562  PMID: 26328133
Article; peer review; response letter; scientific referee
7.  News at Biochemia Medica: Research integrity corner, updated Guidelines to authors, revised Author statement form and adopted ICMJE Conflict-of-interest form 
Biochemia Medica  2013;23(1):5-6.
From the issue 23(1) we have implemented several major changes in the editorial policies and procedures. We hope that those changes will raise awareness of our potential authors and reviewers for research and publication integrity issues as well as to improve the quality of our submissions and published articles. Among those changes is the launch of a special journal section called Research Integrity Corner. In this section we aim to publish educational articles dealing with different research and publication misconduct issues. Moreover, we have done a comprehensive revision of our Instructions to authors. Whereas our former Instructions to authors have mostly been concerned with recommendations for manuscript preparation and submission, the revised document additionally describes the editorial procedure for all submitted articles and provides exact journal policies towards research integrity, authorship, copyright and conflict of interest. By putting these Guidelines into action, we hope that our main ethical policies and requirements are now visible and available to all our potential authors. We have also revised the former Authorship and copyright form which is now called the Author statement form. This form now contains statements on the authorship, originality of work, research ethics, patient privacy and confidentiality, and copyright transfer. Finally, Journal has adopted the ICMJE Form for Disclosure of Potential Conflicts of Interest. From this issue, for each submitted article, authors are requested to fill out the “ICMJE Form for Disclosure of Potential Conflicts of Interest” as well as the Author statement form and upload those forms during the online manuscript submission process. We honestly believe that our authors and readers will appreciate such endeavors. In this Editorial article we briefly explain the background and the nature of those recent major editorial changes.
doi:10.11613/BM.2013.001
PMCID: PMC3900092  PMID: 23457759
scientific misconduct; plagiarism; editorial policies
8.  A retrospective analysis of submissions, acceptance rate, open peer review operations, and prepublication bias of the multidisciplinary open access journal Head & Face Medicine 
Head & Face Medicine  2007;3:27.
Background
Head & Face Medicine (HFM) was launched in August 2005 to provide multidisciplinary science in the field of head and face disorders with an open access and open peer review publication platform. The objective of this study is to evaluate the characteristics of submissions, the effectiveness of open peer reviewing, and factors biasing the acceptance or rejection of submitted manuscripts.
Methods
A 1-year period of submissions and all concomitant journal operations were retrospectively analyzed. The analysis included submission rate, reviewer rate, acceptance rate, article type, and differences in duration for peer reviewing, final decision, publishing, and PubMed inclusion. Statistical analysis included Mann-Whitney U test, Chi-square test, regression analysis, and binary logistic regression.
Results
HFM received 126 articles (10.5 articles/month) for consideration in the first year. Submissions have been increasing, but not significantly over time. Peer reviewing was completed for 82 articles and resulted in an acceptance rate of 48.8%. In total, 431 peer reviewers were invited (5.3/manuscript), of which 40.4% agreed to review. The mean peer review time was 37.8 days. The mean time between submission and acceptance (including time for revision) was 95.9 days. Accepted papers were published on average 99.3 days after submission. The mean time between manuscript submission and PubMed inclusion was 101.3 days. The main article types submitted to HFM were original research, reviews, and case reports. The article type had no influence on rejection or acceptance. The variable 'number of invited reviewers' was the only significant (p < 0.05) predictor for rejection of manuscripts.
Conclusion
The positive trend in submissions confirms the need for publication platforms for multidisciplinary science. HFM's peer review time comes in shorter than the 6-weeks turnaround time the Editors set themselves as the maximum. Rejection of manuscripts was associated with the number of invited reviewers. None of the other parameters tested had any effect on the final decision. Thus, HFM's ethical policy, which is based on Open Access, Open Peer, and transparency of journal operations, is free of 'editorial bias' in accepting manuscripts.
Original data
Provided as a downloadable tab-delimited text file (URL and variable code available under section 'additional files').
doi:10.1186/1746-160X-3-27
PMCID: PMC1913501  PMID: 17562003
10.  The future of JABA: A comment 
doi:10.1901/jaba.1987.20-329
PMCID: PMC1286072  PMID: 16795704
11.  Shortcomings of protocols of drug trials in relation to sponsorship as identified by Research Ethics Committees: analysis of comments raised during ethical review 
BMC Medical Ethics  2014;15:83.
Background
Submission of study protocols to research ethics committees (RECs) constitutes one of the earliest stages at which planned trials are documented in detail. Previous studies have investigated the amendments requested from researchers by RECs, but the type of issues raised during REC review have not been compared by sponsor type. The objective of this study was to identify recurring shortcomings in protocols of drug trials based on REC comments and to assess whether these were more common among industry-sponsored or non-industry trials.
Methods
Retrospective analysis of 226 protocols of drug trials approved in 2010–2011 by three RECs affiliated to academic medical centres in The Netherlands. For each protocol, information on sponsorship, number of participating centres, participating countries, study phase, registration status of the study drug, and type and number of subjects was retrieved. REC comments were extracted from decision letters sent to investigators after review and were classified using a predefined checklist that was based on legislation and guidelines on clinical drug research and previous literature.
Results
Most protocols received comments regarding participant information and consent forms (n = 182, 80.5%), methodology and statistical analyses (n = 160, 70.8%), and supporting documentation, including trial agreements and certificates of insurance (n = 154, 68.1%). Of the submitted protocols, 122 (54.0%) were non-industry and 104 (46.0%) were industry-sponsored trials. Non-industry trials more often received comments on subject selection (n = 44, 36.1%) than industry-sponsored trials (n = 18, 17.3%; RR, 1.58; 95% CI, 1.01 to 2.47), and on methodology and statistical analyses (n = 95, 77.9% versus n = 65, 62.5%, respectively; RR, 1.18; 95% CI, 1.01 to 1.37). Non-industry trials less often received comments on supporting documentation (n = 72, 59.0%) than industry-sponsored trials (n = 82, 78.8%; RR, 0.83; 95% CI, 0.72 to 0.95).
Conclusions
RECs identified important ethical and methodological shortcomings in protocols of both industry-sponsored and non-industry drug trials. Investigators, especially of non-industry trials, should better prepare their research protocols in order to facilitate the ethical review process.
doi:10.1186/1472-6939-15-83
PMCID: PMC4269968  PMID: 25490963
Research ethics committees; Ethical review; Research protocols; Drug trials; Sponsorship; Pharmaceutical industry; Shortcomings
12.  JEAB and JABA on the World Wide Web: a report to readers. 
The Journal of the Experimental Analysis of Behavior (JEAB) and the Journal of Applied Behavior Analysis (JABA) have both established home pages on the World Wide Web. Their addresses are: http://www.envmed.rochester.edu/wwwrap/beh avior/jeab/jeabhome.htm http://www.envmed.rochester.edu/wwwrap/beh avior/jaba/jabahome.htm An important feature of these pages is a powerful program that permits rapid full-text searches of a database consisting of the nearly 5,000 abstracts that have accompanied articles published in JEAB since 1958 and in JABA since 1968. An electronic version of a single article from each issue of each journal is now made available soon after the paper edition of the journal appears.
doi:10.1901/jaba.1996.29-435
PMCID: PMC1284002  PMID: 8995828
13.  In Search of Integrated Specificity: Comment on Denson, Spanovic, and Miller (2009) 
Psychological bulletin  2009;135(6):854-856.
Psychologists have long been interested in the integrated specificity hypothesis, which maintains that stressors elicit fairly distinct behavioral, emotional, and biological responses, molded by selective pressures to meet specific demands from the environment. This issue of Psychological Bulletin features a meta-analytic review of the evidence for this proposition by Denson, Spanovic, and Miller (2009). It concludes that the meta-analytic findings support the “core concept behind the integrated specificity model (p. XX)” and reveal that “within the context of a stressful event, organisms produce an integrated and coordinated response at multiple levels (i.e., cognitive, emotional, physiological; p. XX).” In this commentary I argue that conclusions like this are unwarranted given the data. Aside from some effects for cortisol, in fact, there was little evidence of specificity, and most of the significant findings reported would be expected by chance alone. I also contend that Denson et al. fail to consider some important sources of evidence bearing on the specificity hypothesis, particularly how appraisals and emotions couple with autonomic nervous system endpoints and functional indices of immune response. If selective pressures did give rise to an integrated stress response, such pathways almost certainly would have been involved. By omitting such outcomes from the meta-analysis, the authors have overlooked what are probably the most definitive tests of the specificity hypothesis. As a result, the field is back where it started: with a lot of affection for the concept of integrated specificity, but little in the way of definitive evidence to refute or accept it.
doi:10.1037/a0017440
PMCID: PMC2774222  PMID: 19883138
14.  Comments on the process and product of the health impacts assessment component of the national assessment of the potential consequences of climate variability and change for the United States. 
Environmental Health Perspectives  2001;109(Suppl 2):177-184.
In 1990 Congress formed the U.S. Global Change Research Program and required it to conduct a periodic national assessment of the potential impacts of climate variability and change on all regions and select economic/resource sectors of the United States. Between 1998 and 2000, a team of experts collaborated on a health impacts assessment that formed the basis for the first National Assessment's analysis of the potential impacts of climate on human health. The health impacts assessment was integrated across a number of health disciplines and involved a search for and qualitative expert judgment review of data on the potential links between climate events and population health. Accomplishments included identification of vulnerable populations, adaptation strategies, research needs, and data gaps. Experts, stakeholders, and the public were involved. The assessment is reported in five articles in this issue; a summary was published in the April 2000 issue of Environmental Health Perspectives. The assessment report will enhance understanding of ways human health might be affected by various climate-associated stresses and of the need for further empirical and predictive research. Improved understanding and communication of the significance and inevitability of uncertainties in such an assessment are critical to further research and policy development.
PMCID: PMC1240664  PMID: 11359684
15.  Neurologic adverse events associated with smallpox vaccination in the United States – response and comment on reporting of headaches as adverse events after smallpox vaccination among military and civilian personnel 
BMC Medicine  2006;4:27.
Background
Accurate reporting of adverse events occurring after vaccination is an important component of determining risk-benefit ratios for vaccinations. Controversy has developed over alleged underreporting of adverse events within U.S. military samples. This report examines the accuracy of adverse event rates recently published for headaches, and examines the issue of underreporting of headaches as a function of civilian or military sources and as a function of passive versus active surveillance.
Methods
A report by Sejvar et al was examined closely for accuracy with respect to the reporting of neurologic adverse events associated with smallpox vaccination in the United States. Rates for headaches were reported by several scholarly sources, in addition to Sejvar et al, permitting a comparison of reporting rates as a function of source and type of surveillance.
Results
Several major errors or omissions were identified in Sejvar et al. The count of civilian subjects vaccinated and the totals of both civilians and military personnel vaccinated were reported incorrectly by Sejvar et al. Counts of headaches reported in VAERS were lower (n = 95) for Sejvar et al than for Casey et al (n = 111) even though the former allegedly used 665,000 subjects while the latter used fewer than 40,000 subjects, with both using approximately the same civilian sources. Consequently, rates of nearly 20 neurologic adverse events reported by Sejvar et al were also incorrectly calculated. Underreporting of headaches after smallpox vaccination appears to increase for military samples and for passive adverse event reporting systems.
Conclusion
Until revised or corrected, the rates of neurologic adverse events after smallpox vaccinated reported by Sejvar et al must be deemed invalid. The concept of determining overall rates of adverse events by combining small civilian samples with large military samples appears to be invalid. Reports of headaches as adverse events after smallpox vaccination appear to be have occurred much less frequently using passive surveillance systems and by members of the U.S. military compared to civilians, especially those employed in healthcare occupations. Such concerns impact risk-benefit ratios associated with vaccines and weigh against making vaccinations mandatory, without informed consent, even among military members. Because of the issues raised here, adverse event rates derived solely or primarily from U.S. Department of Defense reporting systems, especially passive surveillance systems, should not be used, given better alternatives, for making public health policy decisions.
doi:10.1186/1741-7015-4-27
PMCID: PMC1647285  PMID: 17096855
16.  Reflections on a Proposed Theory of Reservation-Dwelling American Indian Alcohol Use: Comment on Spillane and Smith (2007) 
Psychological bulletin  2009;135(2):339-346.
In their recent article, N. Spillane and G. Smith (2007) suggested that reservation-dwelling American Indians have higher rates of problem drinking than do either non–American Indians or those American Indians living in nonreservation settings. These authors further argued that problematic alcohol use patterns in reservation communities are due to the lack of contingencies between drinking and “standard life reinforcers” (SLRs), such as employment, housing, education, and health care. This comment presents evidence that these arguments were based on a partial review of the literature. Weaknesses in the application of SLR constructs to American Indian reservation communities are identified as is the need for culturally contextualized empirical evidence supporting this theory and its application. Cautionary notes are offered about the development of literature reviews, theoretical frameworks, and policy recommendations for American Indian communities.
doi:10.1037/a0014819
PMCID: PMC4416400  PMID: 19254084
American Indians; alcohol; problem drinking; reservation
17.  A comment to the paper by Waltman et al., Scientometrics, 87, 467–481, 2011 
Scientometrics  2011;88(3):1011-1016.
In reaction to a previous critique (Opthof and Leydesdorff, J Informetr 4(3):423–430, 2010), the Center for Science and Technology Studies (CWTS) in Leiden proposed to change their old “crown” indicator in citation analysis into a new one. Waltman (Scientometrics 87:467–481, 2011a) argue that this change does not affect rankings at various aggregated levels. However, CWTS data is not publicly available for testing and criticism. Therefore, we comment by using previously published data of Van Raan (Scientometrics 67(3):491–502, 2006) to address the pivotal issue of how the results of citation analysis correlate with the results of peer review. A quality parameter based on peer review was neither significantly correlated with the two parameters developed by the CWTS in the past citations per paper/mean journal citation score (CPP/JCSm) or CPP/FCSm (citations per paper/mean field citation score) nor with the more recently proposed h-index (Hirsch, Proc Natl Acad Sci USA 102(46):16569–16572, 2005). Given the high correlations between the old and new “crown” indicators, one can expect that the lack of correlation with the peer-review based quality indicator applies equally to the newly developed ones.
doi:10.1007/s11192-011-0424-8
PMCID: PMC3153660  PMID: 21949453
Citation; Indicator; h-index; Quality; Excellence; Selection
18.  Replacement names and nomenclatural comments for problematic species-group names in Europe's Neogene freshwater Gastropoda. Part 2 
ZooKeys  2014;13-46.
In the course of a new database project on Miocene to Recent freshwater gastropods of Europe, a great many of primary and secondary homonyms were revealed. Such nomenclatural issues need clarification in order to avoid misunderstandings and wrong statements about geographical distributions and temporal ranges. The following 16 new names are introduced to replace existing homonyms: Theodoxus militaris jurisicpolsakae nom. n., Viviparus stevanovici nom. n., Melanopsis haueri ripanjensis nom. n., Melanopsis wolfgangfischeri nom. n., Micromelania ramacanensis nom. n., Pseudamnicola welterschultesi nom. n., Muellerpalia haszprunari nom. n., Muellerpalia pseudovalvatoides nom. n., Lithoglyphus gozhiki nom. n., Valvata heidemariae willmanni nom. n., Radix macaleti nom. n., Gyraulus okrugljakensis nom. n., Gyraulus rasseri nom. n., Gyraulus vrapceanus nom. n., Planorbarius halavatsi nom. n., and Segmentina mosbachensis nom. n. Additionally, six cases of homonyms are discussed that are not replaced by new names, because they are considered junior synonyms.
doi:10.3897/zookeys.429.7420
PMCID: PMC4137296  PMID: 25147468
Homonyms; synonyms; nomina nova; fossil freshwater gastropods
19.  Status of Cardiovascular Disease and Stroke in Hispanics/Latinos in the United States 
Circulation  2014;130(7):593-625.
Background and Purpose
This American Heart Association (AHA) scientific statement provides a comprehensive overview of current evidence on the burden cardiovascular disease (CVD) among Hispanics in the United States. Hispanics are the largest minority ethnic group in the United States, and their health is vital to the public health of the nation and to achieving the AHA’s 2020 goals. This statement describes the CVD epidemiology and related personal beliefs and the social and health issues of US Hispanics, and it identifies potential prevention and treatment opportunities. The intended audience for this statement includes healthcare professionals, researchers, and policy makers.
Methods
Writing group members were nominated by the AHA’s Manuscript Oversight Committee and represent a broad range of expertise in relation to Hispanic individuals and CVD. The writers used a general framework outlined by the committee chair to produce a comprehensive literature review that summarizes existing evidence, indicate gaps in current knowledge, and formulate recommendations. Only English-language studies were reviewed, with PubMed/MEDLINE as our primary resource, as well as the Cochrane Library Reviews, Centers for Disease Control and Prevention, and the US Census data as secondary resources. Inductive methods and descriptive studies that focused on CVD outcomes incidence, prevalence, treatment response, and risks were included. Because of the wide scope of these topics, members of the writing committee were responsible for drafting individual sections selected by the chair of the writing committee, and the group chair assembled the complete statement. The conclusions of this statement are the views of the authors and do not necessarily represent the official view of the AHA. All members of the writing group had the opportunity to comment on the initial drafts and approved the final version of this document. The manuscript underwent extensive AHA internal peer review before consideration and approval by the AHA Science Advisory and Coordinating Committee.
Results
This statement documents the status of knowledge regarding CVD among Hispanics and the sociocultural issues that impact all subgroups of Hispanics with regard to cardiovascular health. In this review, whenever possible, we identify the specific Hispanic subgroups examined to avoid generalizations. We identify specific areas for which current evidence was less robust, as well as inconsistencies and evidence gaps that inform the need for further rigorous and interdisciplinary approaches to increase our understanding of the US Hispanic population and its potential impact on the public health and cardiovascular health of the total US population. We provide recommendations specific to the 9 domains outlined by the chair to support the development of these culturally tailored and targeted approaches.
Conclusions
Healthcare professionals and researchers need to consider the impact of culture and ethnicity on health behavior and ultimately health outcomes. There is a need to tailor and develop culturally relevant strategies to engage Hispanics in cardiovascular health promotion and cultivate a larger workforce of healthcare providers, researchers, and allies with the focused goal of improving cardiovascular health and reducing CVD among the US Hispanic population.
doi:10.1161/CIR.0000000000000071
PMCID: PMC4577282  PMID: 25098323
AHA Scientific Statements; cardiovascular disease; Hispanic; Latino; stroke
20.  "Any other comments?" Open questions on questionnaires – a bane or a bonus to research? 
Background
The habitual "any other comments" general open question at the end of structured questionnaires has the potential to increase response rates, elaborate responses to closed questions, and allow respondents to identify new issues not captured in the closed questions. However, we believe that many researchers have collected such data and failed to analyse or present it.
Discussion
General open questions at the end of structured questionnaires can present a problem because of their uncomfortable status of being strictly neither qualitative nor quantitative data, the consequent lack of clarity around how to analyse and report them, and the time and expertise needed to do so. We suggest that the value of these questions can be optimised if researchers start with a clear understanding of the type of data they wish to generate from such a question, and employ an appropriate strategy when designing the study. The intention can be to generate depth data or 'stories' from purposively defined groups of respondents for qualitative analysis, or to produce quantifiable data, representative of the population sampled, as a 'safety net' to identify issues which might complement the closed questions.
Summary
We encourage researchers to consider developing a more strategic use of general open questions at the end of structured questionnaires. This may optimise the quality of the data and the analysis, reduce dilemmas regarding whether and how to analyse such data, and result in a more ethical approach to making best use of the data which respondents kindly provide.
doi:10.1186/1471-2288-4-25
PMCID: PMC533875  PMID: 15533249
21.  Biochemia Medica’s editorial policy on authorship 
Biochemia Medica  2015;25(3):320-323.
Recent findings of authorship criteria violations in the manuscripts submitted to Biochemia Medica show that almost 40% of authors do not meet necessary criteria for authorship and thus indicate the need for better dissemination of editorial policy on authorship in our journal. We believe that such cases are mostly due to the authors’ unawareness or the lack of understanding of the authorship criteria. With this article we therefore wish to declare our editorial policy on authorship and authorship criteria. Biochemia Medica endorses the authorship policy provided by the International Committee of Medical Journal Editors (ICMJE). Information on authorship is assessed by self-reported authorship claims during on-line manuscript submission. Those who meet ICMJE criteria shall be listed as authors, and all listed authors shall fulfill ICMJE criteria. All authors should be responsible for content of the article and have to know other authors’ contributions to the study. Biochemia Medica will follow recommendations provided by Committee on Publication Ethics (COPE) flowcharts for possible disputes. By adhering to this procedure we hope to raise awareness about the importance of compliance with ICMJE authorship recommendations.
doi:10.11613/BM.2015.032
PMCID: PMC4622186  PMID: 26525911
authorship; contribution; editorial policy; publication; research integrity
23.  Editorial 
The Editorial office of GSE and EDP Sciences publishing company are pleased to inform you that since October 10, 2005, submission and management of GSE manuscripts are being administered with the help of the Manuscript Management System or MMS software. MMS is a specialised database, which provides information on the manuscripts submitted for publication to GSE. This system permits a simple, reliable and efficient management of the manuscripts during the whole process of reviewing, editing and publication.
Authors are kindly requested to register on the MMS database and to follow instructions for the electronic submission of their manuscripts. After completion of the registration, authors can follow the status of their manuscript directly through MMS.
MMS is accessible at:
doi:10.1186/1297-9686-37-7-585
PMCID: PMC2697238
24.  Editorial Comments, 1974-1986: The Case For and Against the Use of Computer-Assisted Decision Making 
Journal editorials are an important medium for communicating information about medical innovations. Evaluative statements contained in editorials pertain to the innovation's technical merits, as well as its probable economic, social and political, and ethical consequences. This information will either promote or impede the subsequent diffusion of innovations. This paper analyzes the evaluative information contained in thirty editorials that pertain to the topic of computer-assisted decision making (CDM). Most editorials agree that CDM technology is effective and economical in performing routine clinical tasks; controversy surrounds the use of more sophisticated CDM systems for complex problem solving. A few editorials argue that the innovation should play an integral role in transforming the established health care system. Most, however, maintain that it can or should be accommodated within the existing health care framework. Finally, while few editorials discuss the ethical ramifications of CDM technology, those that do suggest that it will contribute to more humane health care. The editorial analysis suggests that CDM technology aimed at routine clinical task will experience rapid diffusion. In contrast, the diffusion of more sophisticated CDM systems will, in the foreseeable future, likely be sporadic at best.
PMCID: PMC2245139
25.  Common Errors in Manuscripts Submitted to Medical Science Journals 
Background:
Many manuscripts submitted to biomedical journals are rejected for reasons that include low-quality of the manuscripts.
Aim:
The aim of this study is to identify and characterize the common errors in manuscripts submitted to medical journals based in Africa and Asia.
Materials and Methods:
Reviewers’ reports on 42 manuscripts were analyzed qualitatively using deductive coding, and quantitatively to determine the errors by sections of the manuscripts. The study included only reviews on full length original research articles.
Results:
Results showed that 66.7% (28/42) of the manuscripts had flaws in the introduction, 85.7% (36/42) in materials and methods, 66.7% (28/42) in the results, 71.4% (30/42) in discussion, 69.0% (29/42) in references, and 81.1% (34/42) in the general sections. Qualitative analysis of the reviews revealed 22 themes. Most common flaws identified were improper review of literature, provision of insufficient detailed methodology, unsystematic or illogical presentation of results, and unsupported conclusions. Others were inconsistent or nonconforming citations, and lack of good grammatical writing.
Conclusions:
The results show that many of the manuscripts had remarkable errors and demonstrate the need for attention to detail in study design and manuscript preparation and for further training of medical scientists in the techniques of manuscript writing for journal publication.
doi:10.4103/2141-9248.117957
PMCID: PMC3793443  PMID: 24116317
Academic writing; Africa; Asia; Manuscript preparation; Peer review

Results 1-25 (491343)