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PubMed1996

An analysis of papers published in the British and European Journals of Orthodontics.

UNLABELLED: The aims of this study were to assess the type, subject, setting and methods of papers published in British Journal of Orthodontics (BJO) and European Journal of Orthodontics (EJO) between 1989 and 1993 to allow all published randomized controlled trials (RCTs) to be identified and a comparison of the papers published in the journals to be made. A hand search of all papers published in BJO and EJO between 1989 and 1993 was performed, and the type, subject, setting, and methods of each paper were classified and recorded. Of the studies, 59.3 per cent related to clinical orthodontics, but only three RCTs were identified in each journal. This comprised 2.8 per cent of the clinical research papers which were analysed. The remaining studies used non-randomized controls or were uncontrolled. Significant differences were found between the type (P < 0.001), subject (P < 0.001), setting (P < 0.01) and methods (P < 0.05) of papers published in the two journals. Relatively more papers in BJO were case reports, clinical opinions and update articles, reported on orthodontic materials or assessed methods of measuring the outcome of treatment. Ninety per cent of papers in EJO reported the results of research projects and relatively more papers, than in BJO, were related to animal studies, and were laboratory based or epidemiological. OBJECTIVES: To identify all randomized controlled trials (RCTs) and compare papers published in two orthodontic journals. DESIGN: A retrospective, observational study. SETTING: The British Journal of Orthodontics (BJO) and European Journals of Orthodontics) (EJO). DATA SOURCE: Papers published between 1989 and 1993. METHOD: A hand search of all papers was performed. The type, subject, setting and methods of each paper were classified and recorded. RESULTS: 200 papers were identified in BJO and 275 in EJO. Six RCTs were identified which represents 2.8 per cent of clinical research papers. Significant differences were found between the type (P < 0.001), subject (P < 0.001), setting (P < 0.01), and methods (P < 0.05) of papers published in the two journals. More papers in BJO were case reports, clinical opinions, and update articles, and reported on orthodontic materials or assessed methods of measuring the outcome of treatment. Ninety per cent of papers in EJU reported the results of research projects. More papers were related to animal studies; were laboratory based on epidemiological. CONCLUSION: Despite the RCT being regarded as the 'Gold Standard' for the evaluation of therapeutic interventions and materials only six (5.1 per cent) of such studies used this method. Significant differences in the type, setting and subject of papers published in BJO and EJO between 1989 and 1993 were found.

Animals↗
PubMed2002

[Quality of clinical trials published in Spain on asthma in comparison to trials in English language journals].

OBJECTIVES: To evaluate the quality of clinical trials on asthma published in Spanish journals in comparison with those published in European or North American English-language journals. METHOD: Clinical trials were identified by searching MEDLINE and the Spanish Medical Index (Indice Médico Español), and by manual searches for trials mentioned in the bibliographies of the previously identified trials. Quality was assessed by the method proposed by Detsky and colleagues in their 1992 article in Journal of Clinical Epidemiology. RESULTS: The articles published in Spanish journals had lower mean quality scores than those in European or North American English-language journals. Trials published in Spain were less likely to give certain details of methodology, including ethics committee approval, details of randomization or patient enrollment and blinding. Among trials published in Spain, those with non-Spanish authors had lower mean quality scores. CONCLUSION: Clinical trials published in Spain on asthma treatments are of poorer quality than those published in English-language journals. Editors should consider using clinical trial quality checklists during the peer review process to raise the standards for published articles.

Clinical Trials as Topic↗
PubMed2006

Open access publishing and author-pays business models: a survey of authors' knowledge and perceptions.

OBJECTIVES: We aimed to assess journal authors' current knowledge and perceptions of open access and author-pays publishing. DESIGN: An electronic survey. SETTING: Authors of research papers submitted to BMJ, Archives of Disease in Childhood, and Journal of Medical Genetics in 2004. MAIN OUTCOME MEASURES: Familiarity with and perceptions of open access and author-pays publishing. RESULTS: 468/1113 (42%) responded. Prior to definitions being provided, 47% (222/468) and 38% (176/468) reported they were familiar with the terms "open access" and "author-pays" publishing, respectively. Some who did not at first recognize the terms, did claim to recognize them when they were defined. Only 10% (49/468) had submitted to an author-pays journal. Compared with non-open access subscription-based journals, 35% agreed that open access author-pays journals have a greater capacity to publish more content making it easier to get published, 27% thought they had lower impact factors, 31% thought they had faster and more timely publications, and 46% agreed that people will think anyone can pay to get published. 55% (256/468) thought they would not continue to submit to their respective journal if it became open access and charged, largely because of the reputation of the journals. Half (54%, 255/468) said open access has "no impact" or was "low priority" in their submission decisions. Two-thirds (66%, 308/468) said they would prefer to submit to a non-open access subscription-based journal than an open access author-pays journal. Over half thought they would have to make a contribution or pay the full cost of an author charge (56%, 262/468). CONCLUSIONS: The survey yielded useful information about respondents' knowledge and perceptions of these publishing models. Authors have limited familiarity with the concept of open-access publishing and surrounding issues. Currently, open access policies have little impact on authors' decision of where to submit papers.

Adult↗
PubMed2004

Empirical evidence for selective reporting of outcomes in randomized trials: comparison of protocols to published articles.

CONTEXT: Selective reporting of outcomes within published studies based on the nature or direction of their results has been widely suspected, but direct evidence of such bias is currently limited to case reports. OBJECTIVE: To study empirically the extent and nature of outcome reporting bias in a cohort of randomized trials. DESIGN: Cohort study using protocols and published reports of randomized trials approved by the Scientific-Ethical Committees for Copenhagen and Frederiksberg, Denmark, in 1994-1995. The number and characteristics of reported and unreported trial outcomes were recorded from protocols, journal articles, and a survey of trialists. An outcome was considered incompletely reported if insufficient data were presented in the published articles for meta-analysis. Odds ratios relating the completeness of outcome reporting to statistical significance were calculated for each trial and then pooled to provide an overall estimate of bias. Protocols and published articles were also compared to identify discrepancies in primary outcomes. MAIN OUTCOME MEASURES: Completeness of reporting of efficacy and harm outcomes and of statistically significant vs nonsignificant outcomes; consistency between primary outcomes defined in the most recent protocols and those defined in published articles. RESULTS: One hundred two trials with 122 published journal articles and 3736 outcomes were identified. Overall, 50% of efficacy and 65% of harm outcomes per trial were incompletely reported. Statistically significant outcomes had a higher odds of being fully reported compared with nonsignificant outcomes for both efficacy (pooled odds ratio, 2.4; 95% confidence interval [CI], 1.4-4.0) and harm (pooled odds ratio, 4.7; 95% CI, 1.8-12.0) data. In comparing published articles with protocols, 62% of trials had at least 1 primary outcome that was changed, introduced, or omitted. Eighty-six percent of survey responders (42/49) denied the existence of unreported outcomes despite clear evidence to the contrary. CONCLUSIONS: The reporting of trial outcomes is not only frequently incomplete but also biased and inconsistent with protocols. Published articles, as well as reviews that incorporate them, may therefore be unreliable and overestimate the benefits of an intervention. To ensure transparency, planned trials should be registered and protocols should be made publicly available prior to trial completion.

Clinical Protocols↗
PubMed2002

Publishing protocols of systematic reviews: comparing what was done to what was planned.

CONTEXT: Publication of research protocols minimizes bias by explicitly stating a priori hypotheses and methods without prior knowledge of results. METHODS: We conducted a retrospective comparative study to assess the extent to which the content of published Cochrane reviews had changed compared with their previously published protocols and to assess any potential impact these changes may have had in introducing bias to the study. We identified previously published protocols for new Cochrane reviews appearing in The Cochrane Library; 2000, issue 3. The texts of published protocols and completed reviews were compared. Two raters independently identified changes to the different sections of the protocol and classified the changes as none, minor, or major. RESULTS: Of the 66 new Cochrane reviews, we identified a previously published protocol for 47 reviews. Of these, 43 reviews had at least 1 section that had undergone a major change compared with the most recently published protocol. The greatest variation between protocols and reviews was in the methods section, in which 68% of reviews (n = 32) had undergone a major change. Changes made in other sections that may have resulted in the introduction of bias included narrowing of objectives, addition of comparisons or new outcome measures, broadening of criteria for the types of study design included, and narrowing of types of participants included. CONCLUSIONS: Research protocols, even if published, are likely to remain, at least to some extent, iterative documents. We found that a large number of changes were made to Cochrane reviews, some of which could be prone to influence by prior knowledge of results. Even if many of the changes between protocol and review improve the overall study, the reasons for making these should be clearly identified and documented within the final review.

Evidence-Based Medicine↗
PubMed2003

Factors associated with failure to publish large randomized trials presented at an oncology meeting.

CONTEXT: Large clinical trials are the criterion standard for making treatment decisions, and nonpublication of the results of such trials can lead to bias in the literature and contribute to inappropriate medical decisions. OBJECTIVES: To determine the rate of full publication of large randomized trials presented at annual meetings of the American Society of Clinical Oncology (ASCO), quantify bias against publishing nonsignificant results, and identify factors associated with time to publication. DESIGN: Survey of 510 abstracts from large (sample size, > or =200), phase 3, randomized controlled trials presented at ASCO meetings between 1989 and 1998. Trial results were classified as significant (P< or =.05 for the primary outcome measure) or nonsignificant (P>.05 or not reported), and the type of presentation and sponsorship were identified. Subsequent full publication was identified using a search of MEDLINE and EMBASE, completed November 1, 2001; the search was updated in November 2002, using the Cochrane Register of Controlled Trials. Authors were contacted if the searches did not find evidence of publication. MAIN OUTCOME MEASURES: Publication rate at 5 years; time from presentation to full publication. RESULTS: Of 510 randomized trials, 26% were not published in full within 5 years after presentation at the meeting. Eighty-one percent of the studies with significant results had been published by this time compared with 68% of the studies with nonsignificant results (P<.001). Studies with oral or plenary presentation were published sooner than those not presented (P =.002), and studies with pharmaceutical sponsorship were published sooner than studies with cooperative group sponsorship or studies for which sponsorship was not specified (P =.02). These factors remained significant in a multivariable model. The most frequent reason cited by authors for not publishing was lack of time, funds, or other resources. CONCLUSIONS: A substantial number of large phase 3 trials presented at an international oncology meeting remain unpublished 5 years after presentation. Bias against publishing nonsignificant results is a problem even for large randomized trials. Nonpublication breaks the contract that investigators make with trial participants, funding agencies, and ethics boards.

Bias↗
PubMed2004

Selective serotonin reuptake inhibitors in childhood depression: systematic review of published versus unpublished data.

BACKGROUND: Questions concerning the safety of selective serotonin reuptake inhibitors (SSRIs) in the treatment of depression in children led us to compare and contrast published and unpublished data on the risks and benefits of these drugs. METHODS: We did a meta-analysis of data from randomised controlled trials that evaluated an SSRI versus placebo in participants aged 5-18 years and that were published in a peer-reviewed journal or were unpublished and included in a review by the Committee on Safety of Medicines. The following outcomes were included: remission, response to treatment, depressive symptom scores, serious adverse events, suicide-related behaviours, and discontinuation of treatment because of adverse events. FINDINGS: Data for two published trials suggest that fluoxetine has a favourable risk-benefit profile, and unpublished data lend support to this finding. Published results from one trial of paroxetine and two trials of sertraline suggest equivocal or weak positive risk-benefit profiles. However, in both cases, addition of unpublished data indicates that risks outweigh benefits. Data from unpublished trials of citalopram and venlafaxine show unfavourable risk-benefit profiles. INTERPRETATION: Published data suggest a favourable risk-benefit profile for some SSRIs; however, addition of unpublished data indicates that risks could outweigh benefits of these drugs (except fluoxetine) to treat depression in children and young people. Clinical guideline development and clinical decisions about treatment are largely dependent on an evidence base published in peer-reviewed journals. Non-publication of trials, for whatever reason, or the omission of important data from published trials, can lead to erroneous recommendations for treatment. Greater openness and transparency with respect to all intervention studies is needed.

Adolescent↗
PubMed2004

Authors' perceptions of electronic publishing: two cross sectional surveys.

OBJECTIVES: To evaluate how acceptable authors find the BMJ's current practice of publishing short versions of research articles in the paper journal and a longer version on the web and to determine authors' attitudes towards publishing only abstracts in the paper journal and publishing unedited versions on bmj.com once papers have been accepted for publication. DESIGN: Two cross sectional surveys. SETTING: General medical journal. PARTICIPANTS: Survey 1: corresponding authors of a consecutive sample of published BMJ research articles that had undergone the ELPS (electronic long, paper short) process. Survey 2: corresponding authors of consecutive research articles submitted to BMJ. RESULTS: Response rates were 90% (104/115) in survey 1 and 75% (213/283) in survey 2. ELPS is largely acceptable to BMJ authors, but there is some concern that electronic information is not permanent and uncertainty about how versions are referenced. While authors who had experienced ELPS reported some problems with editors shortening papers, most were able to rectify these. Overall, 70% thought that the BMJ should continue to use ELPS; 49% thought that publishing just the abstract in the printed journal with the full version only on bmj.com was unacceptable; and 23% thought it unacceptable to post unedited versions on bmj.com once a paper had been accepted for publication. CONCLUSIONS: It is acceptable to authors to publish short versions of research articles in the printed version of a general medical journal with longer versions on the website. Authors dislike the idea of publishing only abstracts in the printed journal but are in favour of posting accepted articles on the website ahead of the printed version.

Attitude↗
PubMed2001

An analysis of articles on neonatal pain published from 1965 to 1999.

OBJECTIVE: To analyze articles on neonatal pain indexed in MEDLINE from 1965 to 1999. METHODS: Papers published since 1965 and indexed in Medline (PubMed ) were considered. The search strategy was: 'pain' (MeSH terms) OR 'pain' (Title word) OR 'pain' (All Fields), AND 'infant, newborn' (MeSH terms). After the search was completed, a printed copy of the references was obtained, and each reference was reviewed to establish its pertinence to the study's objective. For each article, the year of publication, the journal of publication, the language of the journal, the country of the first author, the type of article and the subject were analyzed. RESULTS: Only 545 of 2490 references identified by the MEDLINE search were considered to deal with neonatal pain. Few articles on neonatal pain were published from 1965 to 1985, but the number of articles published on this topic increased sharply after 1985. Most of the papers were published in English (84.6%). The United States, Canada and the United Kingdom were the main countries that published neonatal pain articles (38.6%, 14.2% and 13.3%, respectively). Clinical research articles (31.7%) were published most frequently; the main subjects of all the articles were pain related to colic (20.4%), general neonatal pain issues (13.6%) and procedural pain (13.4%). Pediatrics and Archives of Diseases in Childhood were the journals that published the most articles on neonatal pain (27 and 22, respectively). CONCLUSIONS: Pain in neonates was a neglected subject of publication until the mid-1980s, and, currently, only a few countries seem interested in this type of pain. This lack of interest may be related to the undertreatment of pain in the neonatal period.

Demography↗
PubMed2003

Issues in electronic research publishing: implications for occupational health care.

Electronic publishing (e-publishing) is a global effort to make new scientific findings freely available to the public at the earliest possible time in a centralized Internet repository. Several journals modeled after the PubMedCentral concept offer central and efficient access to biomedical literature while balancing open communication with publishing obligations. Supporters of e-publishing indicate that convenient access to the most current scientific literature in multimedia formats affords occupational and other health care providers tools to supplement practice, answer clinical questions, and network with other professionals. Non-supporters claim that e-publishing may compromise the peer review process, promote weak research and the use of non-scientifically endorsed information, and present technical difficulties to users. Accepting e-publishing requires considering all users and producers of scientific information as potential vehicles to conduct, communicate, disseminate, and retrieve scientific research. The transition will occur more smoothly if standards, including costs, for e-publishing are established and implemented.

Humans↗
PubMed2004

Open access publishing -- panacea or Trojan horse?

There has been a great deal of press material and discussion in recent years regarding open access for online professional publishing. The issue has divided publishers, authors and readers, leaving almost no one neutral. This new concept can potentially affect the majority of publishing businesses, creating new leaders and destroying old ones. It may also, if accepted, radically change the ways we use to store, deliver, and retrieve information. The article presents critical view on the current situation in scientific publishing business indicating constantly rising subscription costs as one of the triggers for a change. The authors analyze the 'open access publishing' idea, pointing out the myths and slogans used by its supporters. The criticism has been expressed on a high costs of publishing shifted on to researchers. The authors propose their solution based on lower submission fees and micro-payments for article access, which might be acceptable to all interested: authors, readers and publishers.

Access to Information↗
PubMed2004

Trial bank publishing: phase I results.

BACKGROUND: Randomized clinical trials (RCTs) are an important source of evidence for clinical practice, but finding and applying RCT reports to care is time consuming. Publishing RCTs directly into machine-understandable "trial banks" may allow computers to deliver RCT evidence more selectively and effectively to clinicians. METHODS: Authors of eligible RCTs published in JAMA or the Annals of Internal Medicine between January 2002 and July 2003 were invited to co-publish their trial in RCT Bank, an electronic knowledge base containing details of trial design, execution, and summary results. Trial bank staff used Bank-a-Trial, a web-based trial-bank entry tool, to enter information from the manuscript into RCT Bank, obtaining additional information as necessary from the authors. RESULTS: The author participation rate rose from 38% to 76% after the first co-published trial was available as an example. Seven diverse RCTs are now co-published, with 14 in progress. CONCLUSIONS: We have demonstrated proof of concept for co-publishing RCTs with leading journals into a structured knowledge base. Phase II of trial bank publishing will introduce direct author submission to RCT Bank.

Databases as Topic↗
PubMed1995

[Published books on pain and its treatment in Spain. Analysis with the ISBN database].

INTRODUCTION: Although analyses have been done on the publishing of scientific articles on pain in Spanish, book publications in the field have not been studied. This article fills that gap. MATERIAL AND METHODS: A bibliography of books with pain approached from a medical standpoint was compiled from ISBN CD-ROM database (updated for 1993). Books going into more than one edition were considered single titles. Multi-volume collections were considered single books. We analyzed type of book, subject, ISBN classification, year, language (of publication and original), publisher and place of publication. RESULTS: Two hundred books were studied. Over 60% had been published within the previous 10 years. The year that showed the most books published was 1990 (19) followed by 1989 (16) and 1988 (16). Output has been rising steadily. One hundred ninety-eight books were published in Spanish and 2 in Catalan. The original language was Spanish in 114 cases, English in 51 cases, French in 21 and German in 7. By ISBN classification, most (146) covered pathology, disease and medical/therapeutic clinical practice. By topic, 51 books were general, 41 treated lumbalgia, sciatica or back pain and 35 covered headaches in general or migraine. Most of the books were issued by trade publishers. The cities most often involved were Barcelona and Madrid. CONCLUSIONS: An increased number of books about pain are being published in Spain, coinciding with a rise in the publication of scientific articles on the subject.

Databases, Bibliographic↗
PubMed2001

Representation of elderly persons and women in published randomized trials of acute coronary syndromes.

CONTEXT: Elderly persons and women were underrepresented in randomized controlled trials (RCTs) prior to 1990. Since then, efforts have been made to correct these biases, but their effect is unclear. OBJECTIVE: To determine whether the percentage of elderly persons and women in published clinical trials of acute coronary syndromes has increased and how this enrollment compared with disease prevalence. DATA SOURCES: The MEDLINE and Cochrane databases were searched for English-language articles from January 1966 to March 2000 regarding myocardial infarction, unstable angina, or acute coronary syndromes. Additional data sources included meta-analyses, review articles, and cardiology textbooks. Estimates of community-based myocardial infarction rates came from the National Registry of Myocardial Infarction and the Worcester Heart Study. STUDY SELECTION: Published RCTs of acute coronary syndrome patients were included and trials enrolling 50 patients or fewer, those without clinical end points, papers published in a language other than English, and unpublished manuscripts were excluded. Of 7645 studies identified, 593 RCTs were selected for review. DATA EXTRACTION: The RCTs were abstracted by 2 of the authors for year of publication, source of support (ie, funding), pharmacotherapy, study phase, number of study sites, trial location, number of patients, mean age of the study population, and any age exclusion criteria for enrollment. DATA SYNTHESIS: The number of published RCTs with explicit age exclusions has declined from 58% during 1966-1990 to 40% during 1991-2000. Trial enrollment of patients aged 75 years or older increased from 2% for studies published during 1966-1990 to 9% during 1991-2000, but remains well below their representation among all patients with myocardial infarction (37%) in the United States. Enrollment of women has risen from 20% for studies published between 1966-1990 to 25% during 1991-2000, but remains well below their proportion of all patients with myocardial infarction (43%) in the United States. CONCLUSIONS: Attempts at making cardiovascular RCTs more inclusive appear to have had limited success; thus, women and elderly persons remain underrepresented in published trial literature relative to their disease prevalence. Because safety and efficacy can vary as a function of sex and age, these enrollment biases undermine efforts to provide evidence-based care to all cardiac patients.

Acute Disease↗
PubMed2002

Adherence of published diabetes mellitus practice guidelines to methodologic standards of guideline development.

There are multiple practice guidelines published pertaining to diabetes care. Experts have formulated methodologic standards of guideline formulation. To determine whether practice guidelines pertaining to diabetes and published in peer-reviewed publications and the Internet adhered to established methodologic standards of guideline development. We identified all guidelines pertaining to diabetes care published between 1980 and 2000 using a computerized search of Medline, the Practice Guidelines Clearinghouse, the Institute for Clinical Systems Improvement Web site, and a global internet search engine. We used a previously validated 25-item assessment tool to determine guideline adherence to methodologic standards in three categories: guideline development and format, identification and summary of evidence, and formulation of recommendations. We conducted a multivariable regression analysis to determine the influence of guideline author, publishing medium, year of publication, and guidelines length on adherence to methodologic standards of guideline development. We evaluated 43 guidelines: 33% published on the Internet, 66% in peer-reviewed journals; 51% published by organizations, and 49% by individual experts. Of a maximum of 25 methodologic standards, the number of standards adhered by a guideline was 9 (range, 2 to 19). Mean proportion (SD) of guidelines that adhered to methodologic standards on guideline development and format was 48% (28); on identification and summary of evidence, 21% (22); and on the formulation of recommendations, 36% (27). Longer guidelines had greater adherence to methodologic standards (P < 0.0001). Guidelines pertaining to diabetes care published on the internet and in peer-reviewed publications do not meet most methodologic standards of guideline development.

Diabetes Mellitus↗
PubMed2002

Fate of abstracts published in the proceedings of the first annual Perinatal Society of Australia and New Zealand Congress in 1997.

OBJECTIVES: To examine the fate of research presented at the first annual Perinatal Society of Australia and New Zealand (PSANZ) Congress in 1997, by determining: the rate of publication in peer-reviewed biomedical journals; publication rate by discipline; journals in which work was published; concordance for aims, conclusions, authors and number of study subjects; and time from presentation to publication. METHODS: A MEDLINE search was conducted for any publication in a peer-reviewed journal resulting from a publishable abstract from the proceedings of the first annual PSANZ Congress in 1997. Searching was completed 42 months post-congress. The concordance of aims, conclusions, authors and number of subjects between abstract and published paper was determined. RESULTS: There were 172 publishable abstracts in the proceedings of the PSANZ Congress in 1997, and 78 (45%) were published as 83 articles. Basic sciences had the highest publication rate (67%) and midwifery the lowest (20%). Articles were published in 41 journals, with one-third of the articles in three paediatric journals. There was a match with aims in 75%, and with conclusions in 65%. There were 47/77 with the same number of subjects, 20/77 with more and 10/77 with fewer. There were 22 articles with one author added, 12 had more than one author added, 11 had one author removed and five had more than one author removed. Median time-to-publication was 18 months (interquartile range 9-26 months). CONCLUSIONS: A publication rate of 45% is comparable to other conferences. Basic science and neonatology had the highest publication rates. There were considerable differences between abstract and published article in terms of aims, conclusions, number of subjects and authors.

Australia↗
PubMed2004

Time trends in the published risks of stroke and death due to endarterectomy for symptomatic carotid stenosis.

BACKGROUND: Large randomised trials performed in the 1980s and early 1990s showed that carotid endarterectomy (CEA) is beneficial for patients with recently symptomatic severe stenosis. Some surgeons have argued that the operative risk of stroke and death has fallen over the last decade due to refinements in operative technique, and that the indications for surgery should therefore now be broadened. Yet, studies of routinely collected data report higher operative mortality than in the trials, and surgical case series without independent post-operative assessment by a neurologist may not provide reliable data on stroke risk. METHODS: We performed a systematic review of all studies published between 1994 and 2001 inclusive that which reported the risks of stroke and death for symptomatic carotid stenosis, and compared the reported risks and patient characteristics with those in the ECST and NASCET and with our previous review of studies published prior to 1995. Pooled estimates of the operative risk of stroke and death were obtained by Mantel-Haenszel meta-analysis. RESULTS: Of 383 studies published between 1994 and 2001, only 45 reported operative risks for patients with symptomatic stenosis separately. The pooled operative risk of stroke and death reported in studies published by surgeons only (4.2%, 95% CI = 2.9-5.5, 34 studies) was significantly lower (p < 0.0001) than that in the ECST and NASCET combined (7.0%, 95% CI = 6.2-8.0), whereas the pooled risk reported in studies that involved neurologists was similar (6.5%, 95% CI = 4.3-8.7, 11 studies, p = 0.6). In contrast, operative mortality in ECST and NASCET was significantly lower than in other studies published between 1994 and 2001. By comparison with our previous review, when stratified according to involvement of neurologists, we found no evidence of a reduction in published risks of death or stroke and death due to CEA between 1985 and 2001. CONCLUSIONS: There is no evidence of a systematic reduction over the last decade in the published risks of stroke and death due to CEA for symptomatic stenosis. Operative risks in studies with comparable outcome assessment are similar to ECST and NASCET. The surgical data from the large trials are still likely therefore to be applicable to routine clinical practice.

Carotid Stenosis↗
PubMed1998

A systematic review of the skeletal effects of estrogen therapy in postmenopausal women. I. An assessment of the quality of randomized trials published between 1977 and 1995.

PURPOSE: To examine the quality of published randomized controlled trials of the effects of estrogen treatment on fracture risk and measures of bone mass. DATA SOURCES: Articles on estrogen treatment for osteoporosis published between 1977 and 1995 were identified by searching Medline and Excerpta Medica databases and bibliographies of original papers and published reviews. STUDY SELECTION: Studies selected were randomized controlled trials of the efficacy of estrogens in preventing loss of bone mass or fractures in postmenopausal women. DATA EXTRACTION: Data extraction and quality assessment were performed in duplicate, with assistance of a manual. Raters were blinded as to authors and their affiliations and the publication details. RESULTS: Of 99 eligible randomized controlled trials published between 1977 and 1995, eight included no extractable data, and 23 contained results that were published in duplicate. Total quality scores increased over time, but this was accounted for by improvements only in the measurement technologies used to estimate bone mineral content or density. There was no improvement in the quality of randomization methods, the extent to which withdrawals were accounted for, or in the baseline comparability of treated and control patients. Neither sample sizes nor durations of follow-up increased over time. CONCLUSIONS: This body of literature fails to address whether estrogen therapy reduces fracture rates, and does not allow for comparison of the effects of different active therapies on change in bone density. Although there were improvements in the techniques for estimating bone mass and delivering estrogen treatment, the studies published in the 1990s were no more informative for making clinical or policy decisions than those published in the 1970s.

Adult↗