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PubMed1994

The quality of clinical trials published in The Journal of Family Practice, 1974-1991.

BACKGROUND: Previous analyses of published clinical trials have identified major deficiencies in reporting, design, analysis, and overall quality. The purpose of this study was to determine the strengths and weaknesses of published clinical trials in family practice, and to identify predictors of quality in these trials. METHODS: Randomized controlled clinical trials published in The Journal of Family Practice from 1974 to 1991 were eligible for the study. Two raters independently evaluated the adequacy and appropriateness of reporting, design, and analysis for each clinical trial, using the Chalmers index for assessing clinical trial quality. Multiple linear regression was used to determine the predictors of quality. RESULTS: The 53 trials included in the study showed deficiencies in reporting, design, and analysis, although fundamental design issues, such as blinding, were a relative strength. On average, the trials scored 35% of the possible points on the scale. Three factors were positively associated with overall quality: year of publication, number of pages of the published report, and the type of intervention. Trials with pharmacologic and non-medication therapy interventions, such as diet, had higher quality scores than did trials with psychosocial or educational interventions. CONCLUSIONS: The overall quality of these clinical trials was less than optimal but comparable to previously analyzed groups of trials. The improvement in quality over time may be related to improvement in the quality of the trials themselves, or more exacting editorial standards, or a combination of the two.

Bias↗
PubMed1994

[The quality of clinical trials published in Spain: an evaluation by an analysis of 3 journals during the 1985-1991 period].

BACKGROUND: The evaluation by readers of a published clinical trial requires that the methodology used in its design and realization be specified in detail. In the present study the quality of clinical trials published in Spain during 1985-1991 has been appraised. METHODS: This is a revision of all clinical studies published from 1985 to 1991 in the following Spanish medical journals: Medicina Clínica, Revista Clínica Española and Revista Española de Enfermedades Digestivas; the studies were assessed by three persons through the use of a questionnaire (checklist) which contained 15 evaluation sections relative to the methodology used in carrying out a study. RESULTS: Only an average of 5.5 (+/- 2.8) aspects of the 15 evaluated aspects were considered adequate in the total of clinical trials. Three of the aspects evaluated: "objective of the study", "end point" and "criteria for assessment of outcome" were considered adequate in more than 75% of the cases. Aspects relative to "loss to follow-up", "statistical methods", "analysis of the results", "collection of adverse events", and "approval by an ethical committee" accounted for most methodological defects, being the percentage of studies with correct information below 20%. As to the remaining sections considered, they were found adequate in an intermediate to low percentage (near 30%). There were no differences in quality among the three journals. A slight increase in quality was observed during the last years. CONCLUSIONS: Major methodological deficiencies appear in the clinical studies published in Spain during the last seven years. The recently approved regulations on clinical trials plus the use of checklists by investigators and journal editors, where detailed ethic and methodological aspects are appraised, can contribute to an increase in quality.

Chi-Square Distribution↗
PubMedDate not supplied

[Bibliometric analysis of the original articles published in the Revista Española de Anesthesiología y Renimación in 10 years (1987-1996)].

OBJECTIVE: To describe the original research articles published in Revista Española De Anestesiología y Reanimación (REAR) from 1987 through 1996, as well as to characterize the citations included in those articles. MATERIAL AND METHODS: The 299 articles published as original research in REAR over the past 10 years (1987 through 1996) were analyzed. The bibliographic aspects examined were coauthorship (authors/paper index), citations per article, isolation in function of language of publication of references, degree of obsolescence of articles based on year of references cited ("half-life"), self-citation and degree of dispersion of citations. RESULTS: The authors/paper index was 5.16 +/- 1.62. No statistically significant difference was found in number of authors over the 10-year study period. Mean number of references cited per article was 24.05 +/- 12.02. We found statistically significant differences for 1993 and the period 1987 to 1988, and 1994 and the year 1987 (p < 0.001). The "half-life" of articles was 6 when analyzing on a year-by-year basis; this index ranged from 5.5 to 7, with no significant annual differences. REAR articles accounted for 4.02% of all citations. English was the most frequent language of cited publications, with 6,240 references (86.8%), followed by Spanish with 621 (8.64%), French with 223 (3.1%) and German with 74 (1.03%). Of the 7,191 references analyzed, 6,447 (89.65%) were of scientific journals. Books are the second most commonly cited type of document, with 623 (8.66%) citations. Analyzing journals cited 25 or more times, we found that 74.19% of the articles (4,783/6,447) had been published in 5.3% of the journals (36/678). Seven journals of anesthesia, which represented 1.03% of all journals (7/678) appeared in 52.81% of references of this type (3,405/6,447). CONCLUSIONS: The number of authors of original research articles published in REAR in the last 10 years was high. Spanish authors in anesthesiology cite mainly literature in English; use up-to-date sources of information, mainly journals; and take a large proportion of information from a small number of journals, which are those of greatest international impact in our specialty.

Anesthesiology↗
PubMed2001

Internationalization of general surgical journals: origin and content of articles published in North America and Great Britain from 1983 to 1998.

HYPOTHESIS: The origin and characteristics of articles published in the 6 highest rated (Institute for Scientific Information classification) English-language general surgical journals have changed significantly during the past 15 years. DESIGN: All articles published in 1983, 1988, 1993, and 1998 in 5 US surgical journals and 1 British surgical journal were reviewed and characterized. MAIN OUTCOME MEASURES: Absolute numbers and proportions of national and international articles published in each journal. RESULTS: Articles reviewed included 4868 in US journals and 1380 in the British journal. The total number of US journal articles decreased by 15.1%. The total number of British journal articles increased by 58.9%. The percentage of national articles decreased from 87.5% to 68.8% in US journals (P<.001) and constituted the minority of freely submitted articles in 1998 in 3 of 5 US journals. The percentage of national articles also decreased from 74.8% to 47.1% in the British journal (P<.001). Articles by European and Asian authors showed the most striking increases in all journals. The percentage of basic research articles declined in US journals from 23.3% to 17.9% (P =.001) owing to a 14.9% decline in national basic research articles. The percentage of clinical randomized studies increased from 2.2% to 4.1% (P<.008), but the increase was attributable to international articles. Government funding alone decreased from 13.6% to 11.2%, and government plus another source of funding decreased from 19.2% to 16.7% for national articles in US journals. CONCLUSIONS: Internationalization of the highly rated British and the 5 highest rated US general surgical journals has occurred. The decrease in the number of national articles in the US journals has been accompanied by significant decreases in government funding and basic research articles and a static output of clinical randomized studies from North America.

Authorship↗
PubMed2001

Negative results of randomized clinical trials published in the surgical literature: equivalency or error?

HYPOTHESIS: We hypothesized that review of randomized controlled clinical trials (RCTs) with nonstatistically significant or "negative" results published in the surgical literature do not have appropriate statistical power to demonstrate equivalency between treatment arms. DATA SOURCES AND STUDY SELECTION: The MEDLINE database was searched to obtain reports of all RCTs with negative results published in 3 surgical journals from 1988 to 1998. Manual review of one year (1997) of publications for each journal was performed to validate our search strategy. Equivalency was evaluated using the Two One-Sided Tests Procedure and post hoc power calculations. DATA SYNTHESIS: Ninety reports of RCTs with negative results were identified in the surgical literature between 1988 and 1998. The manual review of 1997 showed a 100% retrieval rate for our search strategy. After applying the Two One-Sided Tests Procedure, 35 reports (39%) met the criteria for demonstrating equivalency. The other 55 reports (61%) contained at least a 10% absolute difference in the 90% confidence interval of Delta. Using the power calculation method, only 22 (24%) articles had a power greater than.80 to detect a 50% difference in therapeutic effect. Only 29% of the reports included a formal sample size calculation and these studies were more likely to demonstrate equivalency than those without a sample size estimate (P<.01). CONCLUSIONS: Many reports from negative RCTs published in the surgical literature lack sufficient statistical power to establish that clinically important differences are not present. Surgeons should perform appropriate sample size calculations when designing RCTs and recognize the utility of confidence intervals when reporting negative results.

Confidence Intervals↗
PubMed1998

Discussion sections in reports of controlled trials published in general medical journals: islands in search of continents?

CONTEXT: Several journals have adopted the Consolidated Standards of Reporting Trials (CONSORT) recommendations to make assessment of the quality of randomized controlled trials (RCTs) easier. One of these recommendations is that the trial's results be discussed in light of the totality of the available evidence. OBJECTIVE: To assess the extent to which reports of RCTs published in 5 general medical journals have discussed new results in light of all available evidence. DESIGN: Assessment of the discussion sections in all 26 reports of RCTs published during May 1997 in Annals of Internal Medicine, BMJ, JAMA, The Lancet, and The New England Journal of Medicine. MAIN OUTCOME MEASURE: The inclusion or mention of a systematic review in the discussion section of each article. RESULTS: In only 2 articles were the RCT's results discussed in the context of an updated systematic review of earlier trials. In a further 4 articles, references were made to relevant systematic reviews, but no attempts were made to integrate the results of the new trials in updated versions of these reviews. One article was probably the first published trial to address the question studied. The remaining 19 articles included no evidence that any systematic attempt had been made to set the reported trial's results in the context of previous trials. CONCLUSION: There is little evidence that journals have adequately implemented the CONSORT recommendation that results of an RCT be discussed in light of the totality of the available evidence.

Periodicals as Topic↗
PubMedDate not supplied

Accuracy of data in abstracts of published research articles.

CONTEXT: The section of a research article most likely to be read is the abstract, and therefore it is particularly important that the abstract reflect the article faithfully. OBJECTIVE: To assess abstracts accompanying research articles published in 6 medical journals with respect to whether data in the abstract could be verified in the article itself. DESIGN: Analysis of simple random samples of 44 articles and their accompanying abstracts published during 1 year(July 1, 1996-June 30, 1997) in each of 5 major general medical journals (Annals of Internal Medicine, BMJ, JAMA, Lancet, and New England Journal of Medicine) and a consecutive sample of 44 articles published during 15 months (July 1, 1996-August 15, 1997) in the CMAJ. MAIN OUTCOME MEASURE: Abstracts were considered deficient if they contained data that were either inconsistent with corresponding data in the article's body (including tables and figures) or not found in the body at all. RESULTS: The proportion of deficient abstracts varied widely (18%-68%) and to a statistically significant degree (P<.001) among the 6 journals studied. CONCLUSIONS: Data in the abstract that are inconsistent with or absent from the article's body are common, even in large-circulation general medical journals.

Abstracting and Indexing↗
PubMed1996

Federated two-dimensional electrophoresis database: a simple means of publishing two-dimensional electrophoresis data.

While a two-dimensional electrophoresis (2-DE) database is a relatively old concept, in recent years it generated renewed interest within the 2-DE community due to two main factors: (i) The high reproducibility of the current 2-DE method allows 2-DE images to be exchanged and compared between laboratories. (ii) The recent development of faster and more powerful techniques for protein identification such as microsequencing, matrix-assisted laser desorption ionization-mass spectrometry (MALDI-MS) and amino acid composition makes the production of reference protein maps and 2-DE databases cost- and time-effective. Additionally, the Internet network's current increase in popularity, combined with the rapid growth of Internet-connected laboratories, provides a straightforward means of publishing and sharing 2-DE data. While a small number of laboratories have already successfully published their data over the net, the increasing number of 2-DE database servers that are currently being set up will sooner or later require some kind of standardization. Unfortunately, standardization can be a long and cumbersome process inevitably leading to undesirable compromises. A federated database offers a simple and efficient way to publish and share 2-DE data without the need for standardization. Taking advantage of Internet protocols such as World Wide Web, they allow each laboratory to maintain their own database and to interconnect it with other similar databases through the use of active cross-references. This paper first presents guidelines for building a federated 2-DE database that may easily be followed by most laboratories. It then briefly reviews the state-of-the-art in networked 2-DE databases, and finally describes the SWISS-2DPAGE database which fully implements the concept of a federated 2-DE database.

Computer Communication Networks↗
PubMed2004

Full publication of abstracts of randomised controlled trials published at International Continence Society meetings'.

AIMS: To find out how many abstracts reporting randomised controlled trials (RCTs) that are submitted to scientific meetings of the International Continence Society (ICS) are later published in full, and any predictors of full publication. MATERIALS AND METHODS: The appropriate issues of "Neurourology and Urodynamics" and the Proceedings of the ICS for 1998 and 1999 were hand-searched for the abstracts reporting RCTs. Bibliographic databases (Cochrane Controlled Trials Register, MEDLINE, EMBASE, Healthstar, Psychlit, CINAHL) were searched, using the authors' names, to find full publications. Authors were contacted when no full publication was found to check that all full publications had been found. This was repeated for 1987. RESULTS: Sixty-three abstracts reporting RCTs were found in 1998 and 1999. Twenty-five of these (40%) were followed by full publication. The only characteristic that predicted full publication was the use of a no treatment control group. In 1987, 16 of 19 abstracts (84%) went on to be published in full. CONCLUSIONS: The rate of full publication of abstracts reporting RCTs submitted to recent ICS meetings is low. It is lower than the rate of 56% found in other meetings. As it is widely regarded as unethical not to publish in full, ICS members should make every effort to write-up studies for peer-reviewed publication.

Abstracting and Indexing↗
PubMed2004

Scientific production and impact of nuclear medicine in Europe: how do we publish?

We performed a bibliometric search covering a 1-year period to evaluate the number and the scientific "weight" of nuclear medicine papers published from European as compared with other countries. The scientific impact of our discipline was evaluated according to the impact factor of each publication, and we also aimed to identify those countries and topics that are making the principal contributions to the development of our discipline. To this end, a search on MEDLINE (PubMed) was run to find all peer-reviewed articles published between April 2002 and May 2003, using isotope definitions as search terms. A total of 3,292 publications were identified. Of these, 650 were of no nuclear medicine interest, 229 were reviews and 82 had no country specified. In absolute numbers, Europe leads research in nuclear medicine (939 papers, 38.9%) followed by the USA (608 papers, 25.2%). Among European countries, Germany is the nation that is currently making the greatest contribution to the scientific production of nuclear medicine in Europe. Articles concerning the use of nuclear medicine in oncology account for more than one-quarter of all published nuclear medicine papers.

Bibliometrics↗
PubMed1985

Analysis of page utilization and types of articles published in four major American cardiology journals in 1984.

Several peer-review journals devoted exclusively to cardiology are published in the U.S.A. Although the types of articles and the authors of (and reviewers for) the articles in the various American cardiologic journals are similar, the numbers of articles and pages utilized for them in the various journals are quite different. This article summarizes the results of counting the numbers of editorial (non-advertising) pages published and the types of articles published during 1984 in the American Heart Journal, the American Journal of Cardiology, Circulation, and the Journal of the American College of Cardiology.

Cardiology↗
PubMed1989

Is the published literature a reliable guide for deciding between alternative treatments for patients with early cervical cancer?

The quality of the methodology and reporting of studies on the treatment of early cervical cancer published in English and French language over the period 1975-1985 were examined using an explicit, pre-defined protocol aimed at assessing their internal validity and generalizability. One hundred and fifty-two articles reporting results on over 40,000 patients treated with surgery, radiotherapy, or the combination of the two, were examined. The astonishing lack of formal comparative studies together with the poor quality of those actually carried out were the two major findings of our study. More than half of the reviewed papers (54%) were single series studies. Among the remaining 46% only a few formally compared the two treatments (i.e. surgery vs. radiotherapy), the remainder dealing with comparisons of specific surgical or radiotherapeutic techniques. With reference to study quality, the existence of a pre-specified research protocol could not be ascertained in most studies. A description of patients' characteristics and information on the source population were deficient in most papers reviewed; information on the two aspects was in fact satisfactorily reported in only 7% and 47% of the papers, respectively. Finally, the lack of standardization of follow-up methods (i.e. type and modalities) and of information on treatment compliance were two other severe methodological deficiencies. In view of this poor quality and of the intrinsic difficulty of drawing firm scientific conclusions from non-experimental investigations, the reliability of this literature remains highly dubious. Another possible caveat is that what is published is a biased sample of the overall evidence because of the well known tendency of authors to write about and editors to publish positive results more frequently than negative ones.

Clinical Trials as Topic↗
PubMed2005

Research articles published in clinical radiology journals: trend of contribution from different countries.

RATIONALE AND OBJECTIVES: To determine different countries' trend of contribution to clinical radiology journals and its relationship with impact factor. MATERIALS AND METHODS: All the journals, which publish articles on clinical radiology, were selected from the category of Radiology and Nuclear Medicine group of journals, and articles published in these journals between 1991 and 2000 were searched for the authors' affiliation using the Medline database. Then, share of research output of the top-ranking 20 countries was determined along with the trend over time. Also, the relationship of different countries' contribution with the impact factor of journals was examined by cross-sectional time-series linear model. RESULTS: Of total articles (38,359), the United States' share for the selected journals in clinical radiology was 43.2% (16,582 articles) and ranked top in the world, followed by the United Kingdom (9.9%) and Japan (8.0%). The recent increase in the share was statistically significant for Japan, France, Germany, Italy, South Korea, Turkey, Spain, Switzerland, Austria, and China. On the other hand, the United States, United Kingdom, and Canada showed a significant negative trend. Among the top-ranking 10 countries, the US contribution was significantly higher to journals with high-impact factors, whereas the opposite was true for France. CONCLUSION: The United States, United Kingdom, and Canada showed a negative trend over the last decade in terms of proportion of contribution of articles to the clinical radiology journals. However, only the United States published more articles in high-impact factor journals.

Bibliometrics↗
PubMed2006

Ethical process in human research published in thoracic surgery journals.

BACKGROUND: Media reports of ethical transgressions in research with human subjects have increasingly focused attention on clinical investigators and have served to undermine public confidence in medical research. A series of editorials in The Annals of Thoracic Surgery and The Journal of Thoracic and Cardiovascular Surgery in 2002 and 2003 emphasized integrity in research publication. We investigated the extent to which the ethical process was mentioned in reports of thoracic surgical research with human subjects since 2002. METHODS: We reviewed all reports of research involving human subjects published in these journals during the first 6 months of 2002, the first 6 months of 2003, and the last 6 months of 2004 (n = 273, 291 and 288 for each time period, respectively with a total of 852). RESULTS: Ethical process was mentioned in 346 of 852 (41%) investigations. Comparing US and non-US studies, the rates of mentioning ethical process for prospective studies were 76 of 83 (92%) and 178 of 216 (82%), respectively, and for retrospective studies were 75 of 220 (34%) and 18 of 334 (5%), respectively. Between 2002 and 2004, the rates of mentioning ethical process for prospective studies increased from 79 of 101 (78%) to 80 of 89 (90%), and for retrospective studies it increased from 17 of 172 (10%) to 59 of 199 (30%). CONCLUSIONS: There was a significant increase in mention of ethical process from early 2002 to late 2004; however, documentation of appropriate ethical process in human research published in cardiothoracic journals remains less than ideal. The main burden of ensuring ethical process in human investigations rests with researchers, their institutions, and institutional review boards; however, editors can help rectify this problem by requiring adherence to national and international standards in the human subjects' research studies they publish. In adhering to ethical standards, investigators respect the research subjects' right of self-determination and foster public confidence in human research.

Bibliometrics↗
PubMed2006

Is scientific publishing a criminal activity?

A published scientific paper is the end-result of a complex interaction between authors, referees, editors and publishers. Each brings to the process a different agenda, and a widely disparate adherence to standards of competence and integrity. Recent internationally recognized instances of major scientific fraud represent the tip of a potentially large iceberg formed as a consequence of the ineptness or delinquency of one or other elements in the chain of surveillance designed to exercise control over the process of scientific publishing. This subjective analysis attempts to explain why and where the regulatory mechanisms that ought to detect and eliminate the publication or the dissemination by other means of poor, erroneous, or frankly fraudulent scientific finds have broken down, and what can be done to fix them.

Authorship↗
PubMed2006

Obstetrical and gynecological writing and publishing in Europe.

OBJECTIVE: To assess the number and quality of scientific articles published by authors from the European Union (EU) and Germany in the field of obstetrics and gynecology. STUDY DESIGN: Scientific articles published during the years 1980-2003 covered by the Journal Citation Report (JCR) were considered, with a focus on the impact factor (IF), authors' origin, journal country and publishing language. RESULTS: In 2003, there are 53 journals listed by the JCR for the field category 'obstetrics and gynecology', with altogether 3201 publications listed in the Science Citation Index (SCI). From the year 1980, the total number of publications increased persistently. Looking at the top 20 journals in the field of obstetrics and gynecology, there are 12 journals from the US, 8 from Europe. None of these journals has an IF>10 but 30 journals show an IF>1. Over the last 25 years, a growing importance of the English language as scientific language can be observed. CONCLUSION: These data indicate an important role of European research in the field of obstetrics and gynecology comparable to that of US-American research. The English language is gaining importance as scientific language, displacing other languages and contributing to a loss of impact of non-English journals.

Bibliometrics↗
PubMed2004

Society of Gynecologic Investigation: what gets published?

OBJECTIVE: To compare publication rates of the plenary slide presentations (plenary), concurrent slide presentations (concurrent), and poster presentations (poster) at Society for Gynecologic Investigation (SGI) meetings for the interval 1990 to 1999. METHODS: The SGI program and abstract books for years 1990-1999 were examined, with all plenary and twice the number of randomly selected concurrent and poster abstracts identified. For each abstract, PUBMED was used to search for authors and subject topics, if needed. Rates of publication in various journals were compared: group 1: weekly general journals (New England Journal of Medicine [NEJM], Journal of the American Medical Association [JAMA], Nature); group 2: monthly obstetrics/gynecology journals (American Journal of Obstetrics and Gynecology, Obstetrics and Gynecology); and group 3: other journals (Placenta, Journal of Maternal Fetal Medicine, Fertility and Sterility, etc). Factors predicting ultimate publication were assessed by multivariable analysis. RESULTS: Over the 10-year period, 75% of the plenary, 75% of the concurrent, and 66% of the poster abstract presentations were published (P = not significant [NS]), with the majority being published in group 3 journals. Multivariable analysis did not find any factor predictive of publication in plenary, concurrent, or poster groups. Sixty-five percent of all presentations were basic science-related and this did not change over time. CONCLUSIONS: SGI presentations have an overall publication rate of 68%, which is higher than that reported in the literature for other societies (29-45%). Furthermore, the plenary and concurrent publication rates were not different from the poster publication rate. This suggests that all types of presentations are of quality as measured by publication rate. The SGI continues to publish predominantly basic science research, which is one of its missions.

Congresses as Topic↗
PubMed2006

[What is the methodological quality of articles on therapeutic procedures published in Cirugía Española?].

INTRODUCTION: The aim of this study was to determine the methodological quality of articles on therapeutic procedures published in Cirugía Española and to study its association with the publication year, center, and subject-matter. MATERIAL AND METHOD: A bibliometric study that included all articles on therapeutic procedures published in Cirugía Española between 2001 and 2004 was performed. All kinds of clinical designs were considered, excluding editorials, review articles, letters to editor, and experimental studies. The variables analyzed were: year of publication, center, design, and methodological quality. Methodological quality was determined by a valid and reliable scale. Descriptive statistics (calculation of means, standard deviation and medians) and analytical statistics (Pearson's chi2, nonparametric, ANOVA and Bonferroni tests) were used. RESULTS: A total of 244 articles were studied (197 case series [81%], 28 cohort studies [12%], 17 clinical trials [7%], 1 cross sectional study and 1 case-control study [0.8%]). The studies were performed mainly in Catalonia and Murcia (22% and 16%, respectively). The most frequent subject areas were soft tissue and hepatobiliopancreatic surgery (23% and 19%, respectively). The mean and median of the methodological quality score calculated for the entire series was 10.2 +/- 3.9 points and 9.5 points, respectively. Methodological quality significantly increased by publication year (p < 0.001). An association between methodological quality and subject area was observed but no association was detected with the center performing the study. CONCLUSIONS: The methodological quality of articles on therapeutic procedures published in Cirugía Española between 2001 and 2004 is low. However, a statistically significant trend toward improvement was observed.

Bibliometrics↗