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The quality of reporting of randomized clinical trials published in Ophthalmology.

PURPOSE: To evaluate the quality of reporting of all the new randomized clinical trials published during 1999 in OPHTHALMOLOGY: using the CONSORT statement parameters. DESIGN: Descriptive series of published studies. STUDIES INCLUDED: Randomized clinical trials. METHODS: Eligible studies were all randomized clinical trials published in Volume 106 (1999) of OPHTHALMOLOGY: that reported the results of prospectively conducted studies in humans comparing two or more therapeutic options with regard to their effect on one or various outcomes, in which the authors stated that a process of randomization or quasi-randomization was performed before the interventions. Each study was evaluated by two independent observers establishing the specific report in the published manuscript of 57 CONSORT statement descriptors, and consensus was obtained between evaluators. MAIN OUTCOME MEASURES: Overall presence of CONSORT statement descriptors in published reports. RESULTS: The mean number of positive CONSORT descriptors for the 24 eligible randomized clinical trials was 33.42 (standard error of the mean [SEM] 1.57) of 57 possible. This score was significantly different (P: < 0.001) from the score of 16.6 (standard error of the mean 0.6) reported for OPHTHALMOLOGY: in the 1991 to 1994 study by Scherer and Crawley. Of the nine descriptors measuring the quality of abstract reporting, a mean of 6.25 (SEM 0.3) was included in the 24 study abstracts evaluated, significantly different from the Scherer and Crawley score (5.2, SEM 0.2. P: < 0.001). Four and six descriptors increased and decreased, respectively, their reporting in more than 20%. Key descriptors such as hypothesis postulation, primary outcome determination, sample size calculations, and a discussion of the limitations of the study such as bias, imprecision, and internal validity are still reported in less than 42% of clinical trials. CONCLUSIONS: This study describes for the first time after the adoption of the CONSORT statement recommendations the status on the quality of reporting of recently published randomized clinical trials in OPHTHALMOLOGY: Although not a direct measure of the intrinsic quality of a study, reporting quality provides the reader with useful tools for the evaluation of its validity. The quality of reporting of randomized clinical trials shows an overall improvement when compared with the period between 1991 and 1994. However, there is still significant room for improvement, especially in descriptors essential for the validation of clinical trial results that are still widely underreported.

Guidelines as Topic↗

The mind and brain scholar as a hitchhiker in the post-Gutenberg galaxy: publishing at 2000 and beyond.

Electronic journal (e-journal) publishing has started to change the ways we think about publishing. However, many scholars and scientists in the mind and brain sciences are still ignorant of the new possibilities and ongoing debates. This paper will provide a summary of the issues involved, give an update of the current discussion, and supply practical information on issues related to e-journal publishing and self-archiving relevant for the mind and brain sciences. Issues such as differences between traditional and e-journal publishing, open archive initiatives, worldwide conventions, quality control, costs involved in e-journal publishing, and copyright questions will be addressed. Practical hints on how to self-archive, how to submit to the e-journal Psycoloquy, how to create an open research archive, and where to find information relevant to e-publishing will be supplied.

Humans↗

Publishing ethics in psychiatry.

OBJECTIVE: The ethics of publishing in psychiatry has gained only limited attention. We examine, in a historical context, pertinent ethical problems and offer a series of recommendations for dealing with them. METHOD: The study was conducted by exploration of medical databases and websites, and systematic discussion with ethicists, legal experts, publishers and researchers. RESULTS: Serious 'publishing misconduct' appears to have been rare in the psychiatric literature, but any occurrence of redundant publication, plagiarism and publication of fraudulent or inhumane research is disturbing and should be prevented. Difficulties around authorship, sensitive use of language, conflict of interest and bias in the publishing process are additional issues claiming our attention. CONCLUSIONS: A clearly articulated publishing ethos is desirable. Potential strategies to achieve this include devising guidelines on publishing ethics, teaching the subject to new writers, journals committing themselves to the ethical dimension of their operations, and penalising colleagues who violate agreed principles of good conduct.

Ethics, Professional↗

Electronic data publishing and GenBank.

GenBank, the national repository for nucleotide sequence data, has implemented a new model of scientific data management, which we term electronic data publishing. In traditional publishing, both scientific conclusions and supporting data are communicated via the printed page, and in electronic journal publishing, both types of information are communicated via electronic media. In electronic data publishing, by contrast, conclusions are published in a journal while data are published via a network-accessible, electronic database.

Base Sequence↗

Some realities of present-day cardiologic journal publishing in the USA.

The types and quantities of cardiological publications in the USA have changed drastically in recent years. The small, independent medical publisher in the USA is vanishing. Medical publishers in the USA today primarily are parts of larger, nonmedical publishing corporations, and the nonmedical publications are affecting the medical publications. The 'throw-away' journals are increasing and their existence is diminishing the reading time available and advertising support provided to the peer-review subscription journals. The publication of symposia proceedings supported entirely by grants from single pharmaceutical or medical device companies in otherwise peer-review journals is increasing. It is better, in my view, for physicians not to exert efforts to discontinue this practice, which is here to stay, but to exert their influence to reduce excess bias and overstatement. The peer-review subscription journals, most of which are published by for-profit corporations, are the sources of our new medical information and the 'storehouse' of our knowledge. They need our strong support. They need to be published on acid-free paper which will not deteriorate, for they are the permanent record of our information. We need more editorial pages in the peer-review subscription journals so that more review and experimental-type articles can be published, and less pages in the 'throw-away' journals which diminish support available to the peer-review subscription journals.

Cardiology↗

Publishing scientific papers based on Master's and Ph.D. theses from a small scientific community: case study of Croatian medical schools.

AIM: To evaluate publishing activity of medical doctors after they have obtained Master's or Ph.D. degree at the Rijeka and Zagreb University Schools of Medicine in Croatia, and establish the number of journal articles based on these theses. METHODS: Data on Master's and Ph.D. theses defended at the Rijeka and Zagreb University Schools of Medicine in the 1990-1999 period were collected by hand-search of the archive. MEDLINE and Current Contents databases were searched for journal articles resulting from the theses. RESULTS: During the 10-year period, 1,535 Master's and 634 Ph.D. theses were defended at the Rijeka and Zagreb University Schools of Medicine (253 Master's and 138 Ph.D. theses from Rijeka and 1,282 Master's and 496 Ph.D. theses from Zagreb). There were 201 (14%) Master's and 218 (34%) Ph.D. theses that resulted in articles published in journals indexed in MEDLINE (13% of Master's and 11% of Ph.D. theses from Rijeka, and 14% of Master's and 41% of Ph.D. theses from Zagreb). Also, 97 (6%) Master's and 129 (20%) Ph.D. theses that resulted in articles published in Current Contents journals (8% of Master's and 6% of Ph.D. theses from Rijeka, and 6% of Master's and 24% of Ph.D. theses from Zagreb). There was no significant difference between the two Universities with respect to published articles based on Master's theses, but there were significantly more articles from Ph.D. theses in Zagreb (p<0.001). Most of the theses resulted in a single publication (95%), 19 (5%) in 2, and 2 in 3 publications. Out of all 453 journal articles, 31% were published in Croatian and 69% in international journals. CONCLUSION: Most Croatian Master's and Ph.D. theses are not made available to the scientific community. There should be more institutional effort directed at the stimulation of postgraduate students to publish their scientific work.

Academic Dissertations as Topic↗

Publishing biomedical journals on the World-Wide Web using an open architecture model.

BACKGROUND: In many respects, biomedical publications are ideally suited for distribution via the World-Wide Web, but economic concerns have prevented the rapid adoption of an on-line publishing model. PURPOSE: We report on our experiences with assisting biomedical journals in developing an online presence, issues that were encountered, and methods used to address these issues. Our approach is based on an open architecture that fosters adaptation and interconnection of biomedical resources. METHODS: We have worked with the New England Journal of Medicine (NEJM), as well as five other publishers. A set of tools and protocols was employed to develop a scalable and customizable solution for publishing journals on-line. RESULTS: In March, 1996, the New England Journal of Medicine published its first World-Wide Web issue. Explorations with other publishers have helped to generalize the model. CONCLUSIONS: Economic and technical issues play a major role in developing World-Wide Web publishing solutions.

Computer Communication Networks↗

[Is the methodology of our original articles essentially inferior to similar papers published in English-speaking journals?].

Randomised controlled trials reported in languages other than English are generally excluded from systematic reviews. This exclusion is often based in the biased opinion that the strictness of methodology and the quality of assessment of the results are essentially inferior to similar articles reported in English. A study published in 1996 in The Lancet compared completeness of reporting, design characteristics, and analytical approaches of 229 randomised controlled trials published in English, French, German, Italian or Spanish, between 1989 and 1994. Eight of those trials had been published in Revista Medica de Chile. No significant differences were found in any single item analysed, between trials published in English and in other languages. The peer review system applied by a journal and the editorial selection of original articles to be published are crucial determinants of the overall quality of its publications. The role of local journals that publish in languages other than English is most important for the communities they are intended to serve and their contribution to disseminating scientific and other important aspects of medicine should be acknowledged and considered by readers, authors and editors in English-speaking countries, especially when these local journals belong to the mainstream literature included in the major international indexing services.

Humans↗

[Rheumatology research. Analysis of Spanish papers published in 1990-1996 in 9 foreign journals in the field].

BACKGROUND: A relevant increase in the spanish biomedical production has occurred in the last few years. The magnitude, evolution and characteristics of the Spanish scientific production in Rheumatology is here analyzed through the published papers in foreign specialty journals. METHODS: Location in spanish documents published from 1990 to 1996 in nine foreign rheumatology journals of great visibility in MEDLINE. Classification of documents according to type of publication, specialty of authors and type of design. Estimation of bibliometric and collaboration indicators. Analysis of their evolution and comparison with data published for 1987. RESULTS: The number of Spanish documents from 1990 to 1996 doubled and from 1987 to 1996 tripled, with a 54% increase for the four journals with more visibility. In 1996, the spanish documents reached 5% of the total of published documents in several journals. From 1990 to 1996 original papers increased almost four times more than letters, the analytical studies increased almost eight times more than descriptive studies, and the mean expected impact factor of the originals multiplied by 1.6. The published documents by spanish rheumatologists had a more favorable profile--higher ratios for originals: letters, analytical studies: descriptive studies--than publications performed by other specialists in this area. The number of authors by document (median) increased from 5 to 6 during the analyzed period. Seventy-two percent of documents was signed by more than one department and 75% by only one institution. CONCLUSIONS: A relevant increase has occurred in the number and quality spanish documents published in the rheumatology area during the last ten years. To note a lack of collaboration between different institutions and few analytical studies of great complexity: cohort studies and controlled clinical trials.

Humans↗

How accurate are published recurrence rates after rectal prolapse surgery? A meta-analysis of individual patient data.

BACKGROUND: The literature shows wide variations of recurrence rates (RRs) after abdominal surgery for rectal prolapse. The aim of this meta-analysis was to evaluate the accuracy of published RRs. METHODS: An electronic search was performed with no restrictions. Inclusion criterion was abdominal surgery in at least 10 adults with follow-up evaluation of any length of time. Two reviewers screened 1669 references. A total of 190 investigators were asked to provide individual patient data that should be the same used at the time their reports were written. The RR was estimated by actuarial analysis. Investigators were asked for comments on results. RESULTS: Individual patient data from 6 reports published with 273 patients (186 women, 87 men) with a median age of 54 years (range, 18-88 y) were available. Abdominal surgery included mobilization with pexy (88%), with additional resection (7%), or mobilization only (5%). There were 16 recurrences at a median follow-up period of 3.94 years (range, .05-15.11 y). The effect of age (hazard ratio [HR], 2.010; P = .3443), sex (HR, 2.070; P = .4260), surgical technique (HR, .743; P = .7669), and publication (HR, 1.014; P = .8747) on RR was not significant. Two publications reported a RR of 0. In another report, the published and estimated RRs of 15% did not differ. Published RRs differed from estimated RRs in 3 reports (2.5% vs 4%; 7% vs 54%; and 9.6% vs 36%). The pooled odds ratios of 6 reports revealed a borderline significant difference between the published and estimated RRs (P = .066). CONCLUSIONS: Published RRs differed by as much as 47% from the RRs estimated by actuarial analysis depending on event definition and how the data were censored.

Actuarial Analysis↗

404 not found: the stability and persistence of URLs published in MEDLINE.

MOTIVATION: The advent of the World Wide Web has enabled unprecedented supplementation of traditional journal publications, allowing access to resources, such as video, sound, software, databases, datasets too large to publish, and even supplementary information and discussion. However, unlike traditional publications, continued availability of these online resources is not guaranteed. An automated survey was conducted to quantify the growth in Uniform Resource Locators (URLs) published to date in MEDLINE abstracts, their current availability and distribution by journal. RESULTS: Of 1630 unique URLs identified, formatting and/or spelling errors were detected within 201 (12%) of them as published. After corrections were made, a survey revealed that approximately 63% of these URLs were consistently available, and another 19% were available intermittently. The rate of failure was far worse for anonymous login to FTP sites, with only 12 of 33 sites (36%) responding. This survey also shows that journals vary disproportionately in the number of web citations published, suggesting policy implementation among a few could have a profound impact overall. Out of the 306 journals with a URL published in an abstract, Bioinformatics published the most (12% of total). AVAILABILITY: URL database and program available by request.

Abstracting and Indexing↗

Critical review of published microarray studies for cancer outcome and guidelines on statistical analysis and reporting.

BACKGROUND: Both the validity and the reproducibility of microarray-based clinical research have been challenged. There is a need for critical review of the statistical analysis and reporting in published microarray studies that focus on cancer-related clinical outcomes. METHODS: Studies published through 2004 in which microarray-based gene expression profiles were analyzed for their relation to a clinical cancer outcome were identified through a Medline search followed by hand screening of abstracts and full text articles. Studies that were eligible for our analysis addressed one or more outcomes that were either an event occurring during follow-up, such as death or relapse, or a therapeutic response. We recorded descriptive characteristics for all the selected studies. A critical review of outcome-related statistical analyses was undertaken for the articles published in 2004. RESULTS: Ninety studies were identified, and their descriptive characteristics are presented. Sixty-eight (76%) were published in journals of impact factor greater than 6. A detailed account of the 42 studies (47%) published in 2004 is reported. Twenty-one (50%) of them contained at least one of the following three basic flaws: 1) in outcome-related gene finding, an unstated, unclear, or inadequate control for multiple testing; 2) in class discovery, a spurious claim of correlation between clusters and clinical outcome, made after clustering samples using a selection of outcome-related differentially expressed genes; or 3) in supervised prediction, a biased estimation of the prediction accuracy through an incorrect cross-validation procedure. CONCLUSIONS: The most common and serious mistakes and misunderstandings recorded in published studies are described and illustrated. Based on this analysis, a proposal of guidelines for statistical analysis and reporting for clinical microarray studies, presented as a checklist of "Do's and Don'ts," is provided.

Bias↗

Cost-effectiveness of irbesartan in diabetic nephropathy: a systematic review of published studies.

BACKGROUND: To review published studies on the cost-effectiveness of the use of irbesartan for treatment of advance overt nephropathy in patients with type 2 diabetes and hypertension. METHODS: Articles were identified based on a search of the PubMed databases using the keywords 'irbesartan', 'ESRD', 'cost-effectiveness', 'nephropathy' and 'costs', and by personal communication with the authors. Only studies published in the last 10 years were included. All costs data from the cost-effectiveness studies were inflated to 2003 Euros using published governmental conversion tables. RESULTS: Seven published studies were identified, spanning the following country settings: the US, Belgium and France, Germany, Hungary, Italy, Spain, and the UK. In each, the same pharmacoeconomic model was adapted using country-specific data to project and evaluate the clinical and cost outcomes of the treatment arms of the Irbesartan in Diabetic Nephropathy Trial (IDNT) (irbesartan, amlodipine or standard blood pressure control). Mean time to onset of ESRD was 8.23 years for irbesartan, 6.82 years for amlodipine and 6.88 years for the control (values were the same for Belgium, France, Germany, Hungary, Italy and Spain as transition probabilities for progression to ESRD were all derived from the IDNT). Mean cumulative incidence of ESRD was 36% with irbesartan, 49% with amlodipine and 45% with control treatment. Treatment with irbesartan was projected to improve life expectancy compared to both amlodipine and control in all seven published studies. Analysis of total lifetime costs showed that irbesartan treatment was cost saving compared to the other two treatment regimens, due to the associated reduction in ESRD cases. Cost savings with irbesartan became evident very early; after 2-3 years of treatment in most settings. CONCLUSIONS: Modelling studies based on the IDNT published to date suggest that irbesartan treatment in patients with type 2 diabetes, hypertension and advanced nephropathy is both life- and cost-saving compared to amlodipine or control.

Antihypertensive Agents↗

Predictors of physician compliance with a published guideline on management of febrile infants.

BACKGROUND: Previous studies have demonstrated clinicians' poor compliance with published management strategies and protocols, but the reasons why physicians often choose to vary their management of the febrile infant from published guidelines are poorly understood. OBJECTIVE: We conducted a study of physicians to learn more about the issues that influence their decisions in the management of febrile infants. METHODS: A survey study of pediatricians, emergency physicians and family physicians randomly selected from a list of licensed physicians in the United States. Chi square and Kruskal-Wallis tests were used to measure differences in responses by specialty. Odds ratios from logistic regression were used to measure differences in compliance with a recently published guideline. RESULTS: We received 193 completed surveys from pediatricians, 177 from emergency physicians and 104 from family physicians. After controlling for other variables, odds for compliance with a recently published guideline were higher for pediatricians [odds ratio (OR) = 9.13] and emergency physicians (OR = 2.5) than for family physicians (P < 0.001). Factors associated with decreased odds of compliance included more years since graduation from medical school (OR = 0.93), a higher proportion of office visits by children < 1 year of age (OR = 0.97) and increased comfort diagnosing serious bacterial illness (OR = 0.35). Factors associated with increased odds of compliance included a higher perceived likelihood of serious bacterial illness in febrile infants (OR = 1.01) and better reported knowledge of the recently published guideline (OR = 2.01). CONCLUSIONS: We found that specialty as well as other factors were associated with physician compliance with a recently published guideline. This information may facilitate guideline development and implementation by providing a better understanding of what motivates physicians in their clinical decision making.

Adult↗

Electronic publishing and Acupuncture in Medicine.

The internet has fundamentally altered scientific publishing; this article discusses current models and how they affect this journal. The greatest innovation is a new range of open access journals published only on the internet, aimed at rapid publication and universal access. In most cases authors pay a publication charge for the overhead costs of the journal. Journals that are published by professional organisations primarily for their members have some functions other than publishing research, including clinical articles, conference reports and news items. A small number of these journals are permitting open access to their research reports. Commercial science publishing still exists, where profit for shareholders provides motivation in addition to the desire to spread knowledge for the benefit of all. A range of electronic databases now exists that offer various levels of listing and searching. Some databases provide direct links to journal articles, such as the LinkOut scheme in PubMed. Acupuncture in Medicine will continue to publish in paper format; all research articles will be available on open access, but non-subscribers will need to pay for certain other articles for the first 12 months after publication. All Acupuncture in Medicine articles will in future be included in the LinkOut scheme, and be presented to the databases electronically.

Acupuncture↗

A quantitative analysis of qualitative studies in clinical journals for the 2000 publishing year.

BACKGROUND: Quantitative studies are becoming more recognized as important to understanding health care with all of its richness and complexities. The purpose of this descriptive survey was to provide a quantitative evaluation of the qualitative studies published in 170 core clinical journals for 2000. METHODS: All identified studies that used qualitative methods were reviewed to ascertain which clinical journals publish qualitative studies and to extract research methods, content (persons and health care issues studied), and whether mixed methods (quantitative and qualitative methods) were used. RESULTS: 60 330 articles were reviewed. 355 reports of original qualitative studies and 12 systematic review articles were identified in 48 journals. Most of the journals were in the discipline of nursing. Only 4 of the most highly cited health care journals, based on ISI Science Citation Index (SCI) Impact Factors, published qualitative studies. 37 of the 355 original reports used both qualitative and quantitative (mixed) methods. Patients and non-health care settings were the most common groups of people studied. Diseases and conditions were cancer, mental health, pregnancy and childbirth, and cerebrovascular disease with many other diseases and conditions represented. Phenomenology and grounded theory were commonly used; substantial ethnography was also present. No substantial differences were noted for content or methods when articles published in all disciplines were compared with articles published in nursing titles or when studies with mixed methods were compared with studies that included only qualitative methods. CONCLUSIONS: The clinical literature includes many qualitative studies although they are often published in nursing journals or journals with low SCI Impact Factor journals. Many qualitative studies incorporate both qualitative and quantitative methods.

Bibliometrics↗

Supplement to the Carcinogenic Potency Database (CPDB): results of animal bioassays published in the general literature in 1993 to 1994 and by the National Toxicology Program in 1995 to 1996.

The Carcinogenic Potency Database (CPDB) is a systematic and unifying analysis of results of chronic, long-term cancer tests. This paper presents a supplemental plot of the CPDB, including 513 experiments on 157 test compounds published in the general literature in 1993 and 1994 and in Technical Reports of the National Toxicology Program in 1995 and 1996. The plot standardizes the experimental results (whether positive or negative for carcinogenicity), including qualitative data on strain, sex, route of compound administration, target organ, histopathology, and author's opinion and reference to the published paper, as well as quantitative data on carcinogenic potency, statistical significance, tumor incidence, dose-response curve shape, length of experiment, duration of dosing, and dose rate. A numerical description of carcinogenic potency, the TD(subscript)50(/subscript), is estimated for each set of tumor incidence data reported. When added to the data published earlier, the CPDB now includes results of 5,620 experiments on 1,372 chemicals that have been reported in 1,250 published papers and 414 National Cancer Institute/National Toxicology Program Technical Reports. The plot presented here includes detailed analyses of 25 chemicals tested in monkeys for up to 32 years by the National Cancer Institute. Half the rodent carcinogens that were tested in monkeys were not carcinogenic, despite usually strong evidence of carcinogenicity in rodents and/or humans. Our analysis of possible explanatory factors indicates that this result is due in part to the fact that the monkey studies lacked power to detect an effect compared to standard rodent bioassays. Factors that contributed to the lack of power are the small number of animals on test; a stop-exposure protocol for model rodent carcinogens; in a few cases, toxic doses that resulted in stoppage of dosing or termination of the experiment; and in a few cases, low doses administered to monkeys or early termination of the experiment even though the doses were not toxic. Among chemicals carcinogenic in both monkeys and rodents, there is some support for target site concordance, but it is primarily restricted to liver tumors. Potency values are highly correlated between rodents and monkeys. The plot in this paper can be used in conjunction with the earlier results published in the CRC Handbook of Carcinogenic Potency and Genotoxicity Databases [Gold LS, Zeiger E, eds. Boca Raton FL:CRC Press, 1997] and with our web site (http://potency.berkeley.edu), which includes a guide to the plot of the database, a complete description of the numerical index of carcinogenic potency (TD50), and a discussion of the sources of data, the rationale for the inclusion of particular experiments and particular target sites, and the conventions adopted in summarizing the literature. Two summary tables permit easy access to the literature of animal cancer tests by target organ and by chemical. For readers using the CPDB extensively, a combined plot on diskette or other format is available from the first author. It includes all results published earlier and in this paper, ordered alphabetically by chemical. A SAS database is also available.

Animals↗

The quality of published adverse drug event reports.

BACKGROUND: Case reports of adverse drug events (ADEs) are an important source of information. OBJECTIVE: To determine what variables are reported in ADE case reports, how causality was assessed for each report, and what criteria are specified for publishing ADE case reports. METHODS: A descriptive analysis of highly significant ADE case reports published in English over a 20-year period was performed. Main outcome measures included frequency distributions for the types of variables reported. The presence of causality assessment and the criteria for submitting an ADE report to practitioner journals were also examined. RESULTS: A highly significant ADE was described in 1520 published case reports during the study period. Three patient variables were reported >90% of the time, while 12 others were reported <25% of the time. Only 1 drug variable was reported >90% of the time; 6 others were reported 14-74% of the time. Most of the relevant ADE variables were reported most often. Added information for drug interactions, medication errors, and allergic drug reactions were reported 61-99% of the time. Less than 1% of ADE reporters objectively assessed the probability of the ADE. All but one journal publishing the most ADE reports did not require such assessment. CONCLUSIONS: Professional journals might consider stricter requirements for publishing ADE reports. As a minimum, requirements should include an objective assessment of ADE causality, with explicit recognition in the published text and abstract of the report.

Adverse Drug Reaction Reporting Systems↗