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Are the cochrane group registers comprehensive? A case study of Japanese psychiatry trials.

BACKGROUND: Language bias is a form of publication bias and constitutes a serious threat to meta-analyses. The Cochrane Controlled Trials Register is one attempt to remedy this and now contains more than 300,000 citations. However we are still unsure if it provides comprehensive coverage, particularly for non-English trials. METHODS: We have recently established a comprehensive register of Japanese trials of psychotropic drugs through extensive personal contacts, electronic searches and handsearches. We examined two Cochrane psychiatry group registers against this Japanese database. RESULTS: The Japanese register contained 56 reports of randomized controlled trials (RCTs) of antidepressants for depression but the Cochrane Depression, Anxiety and Neurosis group register contained 18, with an overlap of only nine. The Japanese register contained 61 reports of RCTs of neuroleptics for schizophrenia and the Cochrane Schizophrenia group register contained 36, with an overlap of only six. Taking account of some duplicate publications, only a quarter to a third of all relevant Japanese RCTs were retrievable from the Cochrane group registers. CONCLUSIONS: Similar, or worse, yields may be expected with RCTs conducted in other East Asian countries, and in other fields of medicine. What evidence there is suggests that this situation may lead to a systematic over estimate of treatment effect.

Antidepressive Agents↗

[A national prospective trial register for randomised controlled trials: ethical and practical necessity].

The decision to treat a patient is often based on the results of randomised controlled trials (RCTs). These important investigations inform physicians and patients with regard to the chance of favourable results of treatment and the risks of adverse reactions. However, research has shown that especially the smaller RCTs in which no or even an adverse effect of new interventions is found run a relatively high risk of remaining unpublished, which leads to publication bias and an overestimate of the efficacy of an intervention. This is undesirable. The best way to identify possible publication bias and reduce its negative effects is to register RCTs from their starting date onwards in a prospective and publicly accessible register. Other motives for such a register are the prevention of duplication of research work and its financial support, and informing patients. Currently, a prospective Dutch national trial register is being developed by the Dutch Cochrane Centre. This is not only of importance to researchers and patients, but also to grant-providing bodies and the editors of medical scientific journals.

Humans↗

Using technology to develop and distribute patient education storyboards across a health system.

PURPOSE/OBJECTIVES: To describe the successful implementation of a centrally designed and managed patient education storyboard project using Microsoft PowerPoint in a large multihospital system and physician-based practice settings. DATA SOURCES: Journal articles, project evaluation, and clinical and educational experience. DATA SYNTHESIS: The use of posters, bulletin boards, and storyboards as educational strategies has been reported widely. Two multidisciplinary committees applied new technology to develop storyboards for patient, family, and general public education. CONCLUSIONS: Technology can be used to coordinate centralized development of patient education posters, improving accuracy and content of patient education across a healthcare system while streamlining the development and review process and avoiding duplication of work effort. IMPLICATIONS FOR NURSING: Storyboards are excellent sources of unit-based current, consistent patient education; reduce duplication of efforts; enhance nursing computer competencies; market nursing expertise; and promote nurse educators.

Awareness↗

SUBJECT HEADINGS IN THE WELLCOME HISTORICAL MEDICAL LIBRARY.

The strength and unity of the medical library profession spring largely from the existence of the National Library of Medicine. Its publications promise to bring much closer the standardization and consistency still lacking to the world of medical subject headings. The Wellcome Library headings are similar to those listed in the National Library of Medicine Subject Heading Authority List of 1960. However, references and additional headings are made to cover (1) superseded terms, (2) historical phenomena with distinctive names which are peculiar to an epoch, (3) subjects from social, religious, or other branches of history, and (4) eponyms. Old texts often describe disease ambiguously or use terminology which has since been superseded. The catalogue is in three parts-topographical, biographical, and topical. The quarterly Current Work has certain simplifications (e.g., elimination of some subheadings), and has recently introduced references both to cut down needless duplication and to facilitate consultation by the reader.

England↗

Redundant surgical publications: tip of the iceberg?

BACKGROUND: A redundant publication is one which duplicates previous, simultaneous, or future publications by the same author or group or, alternatively, could have been combined with the latter into one paper. As there is no information about the extent of this problem in the surgical literature, we set out to assess the incidence, spectrum, and salient characteristics of redundant publications in 3 leading surgical journals. METHODS: Original articles (excluding reviews, editorials, abstracts, and letters) published during 1998 in the journals Surgery, The British Journal of Surgery, and Archives of Surgery were searched by using the on-line search engine PUBMED. Each original article was scrutinized to identify redundancy by combining the names of the first, second, and last authors with a few key words from the title. Papers were defined as "suspected" redundant publications if they were found to address the same topic as the "index" article and shared some or most of the elements of methodology, results, or conclusions. The full versions of all suspected papers were retrieved and compared with the index articles. A grading system was developed to define several types of redundant publications: A. "dual"; B. "potentially dual"; C. "salami-slicing." RESULTS: A total of 660 articles were screened. There were 92 index articles (14%) leading to 147 suspected papers found in other journals, representing some potential form of a redundant publication. The vast majority of suspected papers were published within approximately a year of the index paper and were not cited by the latter. Most (69%) of the suspected papers were also published in surgical journals. Only 12 (8.1%) appeared in, or originated from, a "local-foreign" journal. Twenty (13.6%) of the suspected papers met the criteria for dual publications, 50 (34%) for potentially dual publications, and 77 (52.4%) were considered products of salami-slicing. CONCLUSIONS: Almost 1 in every 6 original articles published in leading surgical journals represents some form of redundancy. Current on-line search technology provides an effective tool for identifying and tracing such publications, but it is not used routinely as part of the peer review process. Redundancies occur in several well-defined patterns; the phenomenon is widespread, and it cuts across the entire spectrum of surgeons in the United States and abroad. Redundant publications must be recognized not as a mere nuisance but as a real threat to the quality and intellectual impact of surgical publishing.

General Surgery↗

Analysing spatially referenced public health data: a comparison of three methodological approaches.

In the analysis of spatially referenced public health data, members of different disciplinary groups (geographers, epidemiologists and statisticians) tend to select different methodological approaches, usually those with which they are already familiar. This paper compares three such approaches in terms of their relative value and results. A single public health dataset, derived from a community survey, is analysed by using 'traditional' epidemiological methods, GIS and point pattern analysis. Since they adopt different 'models' for addressing the same research question, the three approaches produce some variation in the results for specific health-related variables. Taken overall, however, the results complement, rather than contradict or duplicate each other.

Adult↗

Selection and evaluation of empirical research in technology assessment.

Technology assessment involves application of the scientific method to the practice of medicine. Finding all of the assessment reports in a given field is not an easy task. Proper evaluation of those assessments requires the conduct of a prospective experiment in which the sources and results are blinded when the choice is made of papers to exclude and to include, and the process should be carried out in duplicate. There are several available data bases for carrying out the search, but because of indexing problems they should be supplemented by reference to the bibliographies of pertinent published articles. Clinical trials included in meta-analyses should be graded by quality and thus facilitate sensitivity analyses. Attention must be paid to the possibility of publication bias. Finally, the advent of meta-analysis makes it desirable to begin randomized controlled trials in areas of uncertainty, even when there is no possibility that individual investigators will encounter enough patients to draw valid conclusions.

Clinical Trials as Topic↗

[Proliferation of medical schools in latin America. Causes and consequences].

Significant changes in university education have occurred in Latin America, caused by the strategic importance that it has on economical and social development. The educational system expanded and science, technology and informatics, experienced an important development. The eighties were characterized by a reduction in government expenditures, a more efficient use of resources, an increase in the number and variety of universities and university students. The creation of new universities, mostly private, was favored by a highly unregulated market. In Latinamerica, more new universities were created during the eighties than in the previous one hundred years. Since 1981, the number of universities in Chile increased from 8 to 60, the type of institutions was diversified, the government financing of public universities decreased substantially and the regulatory role of the market was emphasized. These changes have been quantitatively understandable but qualitatively unsatisfactory. Since 1981, the number of university students between 19 and 24 years old has triplicated. The number of medical schools and the annual admission of students has duplicated. In most Latin American countries, there is an insufficient number of physicians (Chile has one physician per 783 inhabitants). Since the decade of the nineties, an effort has been made to regulate the market, to introduce new barriers for the acceptance of new educational institutions, to improve the transparency of the system and to preserve the quality of teaching. The quality control of medicine and health is one of the most serious problems in Latin American countries. This includes accreditation of medical schools, health centers and specialists. In Chile there have been some progress in these topics but quality control is still unsatisfactory.

Chile↗

Selective serotonin reuptake inhibitors (SSRIs) in the treatment of elderly depressed patients: a qualitative analysis of the literature on their efficacy and side-effects.

A qualitative analysis of studies on the efficacy and side-effects of selective serotonin reuptake inhibitors (SSRIs) for the treatment of elderly people with depression is presented. Only placebo-controlled or comparison studies of SSRI versus other antidepressants were included. The description and methodological quality of the analysed studies were important criteria in the outcome of the analysis. Quality was assessed by means of a blinded review approach. After excluding duplicate publications, 16 studies were analysed, of which six turned out to be of good quality. The results indicated that at the end of the treatment periods (4-8 weeks) all antidepressants were equally effective. Side-effects occurred less frequently with SSRIs than with tricyclics (TCAs), and different side-effect profiles were found. Significantly fewer SSRI-treated patients than TCA-treated patients dropped out both overall and due to side-effects.

1-Naphthylamine↗

The Norwegian approach to integrated quality development.

The UK NHS quality proposals require all NHS organisations to develop an "integrated approach " to quality. In other countries, health care organisations are also working to ensure that the many different quality methods and systems used in health organisations do not duplicate or conflict with each other. The question this paper addresses is "what would an integrated approach to quality look like and how might managers and clinicians develop such an approach in their organisation?" The findings from the Norwegian total quality management experiment in six hospitals were that TQM could not be applied in its pure form in public health care services to ensure integration. The paper draws on this research to describe these hospitals' approach to integrate the different projects and systems which were stimulated by their initial quality programmes. The paper describes the "integrated quality development" approach which characterised these programmes.

Critical Pathways↗

A cancer education and prevention center. A community program.

The Cancer Education and Prevention Center at Samuel Merritt Hospital in Oakland, CA is one of the 27 American Cancer Society (ACS)-National Cancer Institute (NCI) breast cancer demonstration projects. In 1980 it was converted to a General Cancer Screening Clinic for men and women. Its goal is to not only detect cancer, but to teach patients about the most current methods of self-examination and surveillance. In addition, there is a thorough assessment of each patient's risk factors for cancer, and attempts are made to assist them in altering life styles and habits by reducing potential for future cancer. Many community physicians perceived the hospital-based Screening Center as a potential duplication of medical services to their private patients. Several methods were used to solve this and other problems. Many innovative projects at the Center were used to promote both professional education and training to physicians and other health professionals, as well as public education for the community. Five thousand nine hundred thirty-four patients have been screened. There were 175 presentations to the community and 508 Clinic classes with 76 training sessions at the Center. A hospital-based Cancer Education and Prevention Center of this type can offer a service to the community and be a rich source of in-depth education for both professionals and for the public.

Community Health Centers↗

Ethics and scientific publication.

This article summarizes the major categories of ethical violations encountered during submission, review, and publication of scientific articles. We discuss data fabrication and falsification, plagiarism, redundant and duplicate publication, conflict of interest, authorship, animal and human welfare, and reviewer responsibility. In each section, pertinent historical background and citation of relevant regulations and statutes are provided. Furthermore, a specific case(s) derived from actual situations is(are) presented. These cases were chosen to highlight the complexities that investigators and journals must face when dealing with ethical issues. A series of discussion questions follow each case. It is our hope that by increasing education and awareness of ethical matters relevant to scientific investigation and publication, deviations from appropriate conduct will be reduced.

Animals↗

Are intubation conditions using rocuronium equivalent to those using succinylcholine?

OBJECTIVE: To determine whether the intubation conditions created by rocuronium are equivalent to those of succinylcholine during rapid-sequence induction (RSI). METHODS: Medline, EMBASE, and the Cochrane Controlled Trials Register were searched for randomized clinical trials (RCTs). The search strategy included all generic and trade names for succinylcholine and rocuronium, anesthesia, neuromuscular blockade, and a validated RCT filter. Intubation conditions were a required outcome. Two reviewers assessed studies for eligibility, data extraction, and quality. Intubation conditions were scored with Goldberg's scale (excellent conditions defined as clear vocal cords, easy tube insertion, and no cough). A-priori subgroup analysis was conducted for the sedative, use of opioids, true versus modified RSI, age group, and the dose of rocuronium. Data were analyzed with Metaview 4.1 for relative risk (RR) of achieving excellent intubation conditions. A sample size calculation determined that n = 468 is required for equivalence. RESULTS: Forty articles were identified; ten articles were excluded by the inclusion criteria, two were duplicate publications, and two had insufficient data. Therefore, 26 studies were analyzed. Overall, rocuronium was inferior to succinylcholine, with a RR = 0.87 (95% CI = 0.81 to 0.94) (N = 1,606). However, intubation conditions were similar in the propofol subgroup, with a RR = 0.96 (95% CI = 0.87 to 1.06) (N = 640). Failed intubations (N = 28) were equivalent in the two groups. CONCLUSIONS: Overall, succinylcholine creates excellent intubation conditions more reliably than rocuronium. If a second-line agent is required, rocuronium used with propofol creates intubation conditions equivalent to those with succinylcholine.

Adult↗

"Rainbow reviews." IV: Recent publications of the National Center for Health Statistics.

I am always impressed at the wealth of interesting and useful information available from the NCHS, if one knows where to look. The Center tries to adapt to the changing needs of the potential users of their data, including health planners and policy analysts, and academicians. This is illustrated by the increasing emphasis on medical care utilization, especially in long term care, on disease prevention and health promotion issues and on international comparisons. Clinical investigators should be familiar with the NCHS reports, if only to avoid duplication of effort. But beyond that, the information they present can be used to develop hypotheses, estimate variances for sample size determinations, and provide useful model instruments and methods. Beyond that, the NCHS does not analyze and report exhaustively on these data, if only because of lack of resources, so that it makes most of these data available for further research at a nominal charge. Many doctoral dissertations have been based on these tapes as the primary data source for detailed content analysis and/or for methodologic innovation.

Government Publications as Topic↗

A network of investigator networks in human genome epidemiology.

The task of identifying genetic determinants for complex, multigenetic diseases is hampered by small studies, publication and reporting biases, and lack of common standards worldwide. The authors propose the creation of a network of networks that include groups of investigators collecting data for human genome epidemiology research. Twenty-three networks of investigators addressing specific diseases or research topics and representing several hundreds of teams have already joined this initiative. For each field, the authors are currently creating a core registry of teams already participating in the respective network. A wider international registry will include all other teams also working in the same field. Independent investigators are invited to join the registries and existing networks and to join forces in creating additional ones as needed. The network of networks aims to register these networks, teams, and investigators; be a resource for information about or connections to the many networks; offer methodological support; promote sound design and standardization of analytical practices; generate inclusive overviews of fields at large; facilitate rapid confirmation of findings; and avoid duplication of effort.

Databases, Genetic↗

Intrapartum chemoprophylaxis of perinatal group B streptococcal infections: a critical review of randomized controlled trials.

The purpose of this overview was to critically appraise all published randomized, controlled trials evaluating the efficacy of intrapartum chemoprophylaxis in reducing perinatal group B streptococcal infections. The Oxford Database of Perinatal Trials, Medline, Excerpta Medica, and personal files were used for the literature search. By means of present inclusion criteria to select relevant articles, two independent researchers identified nine randomized, controlled trials. Three trials were excluded because of duplicate publication, one because the randomization process was violated, and one because the outcome data were collected retrospectively. The quality of the methods of the four accepted trials was poor, and because of basic flaws meta-analyses of trial results were not performed. Results of three studies showed a statistically significant reduction in neonatal group B streptococcal colonization rates with intrapartum chemoprophylaxis. Although a trend toward a reduction in proved neonatal infection was reported in three studies, each lacked the power to reach statistical significance. Intrapartum chemoprophylaxis to reduce perinatal group B streptococcal infections is not supported by conclusive evidence from well designed and conducted randomized, controlled trials.

Bacteremia↗

Development of a reversed-phase ion-pairing liquid chromatographic assay of daunorubicin for pharmacopoeial use.

A liquid chromatographic method is described for the determination of daunorubicin using octyldecylsilyl columns and sodium dodecyl sulphate as ion-pairing agent. The method based on previous publication [M. A. van Lancker et. al., J. Chromatogr., 254 (1983) 45] is specific for daunoribicin and separates it from likely impurities, e.g., the aglycone, duborimycin and related anthracyclines, doxorubicin and epirubicin. Several commercial batches have been examined in a number of laboratories employing various types of stationary phases. The intralaboratory reproducibilities varied from 1.0 to 1.6% and the interlaboratory reproducibility between 0.63 and 1.0% (based on the means of duplicate determinations), while with the preferred mobile phase the coefficient of variation was 0.3% (n = 4). The method is robust and is proposed for inclusion in a monograph on daunorubicin which is currently under consideration by the European Pharmacopoeia.

Antibiotics, Antineoplastic↗

Quality of RCTs in periodontology--a systematic review.

Randomization, concealment of treatment allocation, blinding, and patient follow-up are key quality components of randomized controlled trials (RCTs). The objective of this study was to assess the quality of RCTs in periodontology using these evidence-based components. Following a detailed search, screening and quality assessments of RCTs were conducted in duplicate and independently. The results showed that although 91% of trials were described as randomised, adequate methods for randomization and allocation concealment were found in 17% and 7% of studies, respectively. Blinding was adequate for the caregiver in 17% and for the examiner in 55% of studies. A clear accounting of all participants was present in 56% of reports. This rigorous systematic review revealed that the quality of RCTs in periodontology, judged by their publications, frequently does not meet recommended standards. If this quality is reflected in actual study conduct, fundamental errors could have a significant impact on the outcomes of these trials.

Dental Research↗