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PubMed2005

Lack of herbal supplement characterization in published randomized controlled trials.

PURPOSE: Herbal supplements in the United States and abroad have poor quality control and high content variability. We assessed the extent to which recently published randomized controlled trials of herbal supplements characterized and verified the content of the supplement under study. METHODS: We identified all MEDLINE-indexed English language randomized controlled trials evaluating single-herb preparations of echinacea, garlic, ginkgo, saw palmetto, or St. John's wort that were published between January 1, 2000, and February 9, 2004. From each article we extracted information characterizing the herbal supplement studied. RESULTS: Of 81 randomized controlled trials meeting inclusion criteria, 12 (15%) reported performing tests to quantify actual contents, and 3 (4%) provided adequate data to compare actual with expected content values of at least one chemical constituent. In those 3 studies, actual content varied between 80% and 113% of expected values. Studies of higher overall quality (Jadad score > or =3) performed testing somewhat less frequently (5/54; 9%) than those with lower Jadad scores (7/27; 26%) (P = .09). CONCLUSION: Documented characterization of herbal supplements in published randomized controlled trials is inadequate. Investigators may be unaware of the extent to which herbal quality-control issues may detract from the value of otherwise well-designed clinical trials. The scientific and clinical utility of future herbal randomized controlled trials would be enhanced if authors provided evidence that the herbal products studied were of high quality.

Drug Contamination↗
PubMed2006

Prevention of catheter-related bloodstream infections: analysis of studies published between 2002 and 2005.

As the most recent guidelines for the prevention of catheter-related bloodstream infections (CR-BSIs) were published four years ago, a systematic review was conducted to determine whether any recently published articles should further influence existing guidelines. Articles published between 2002 and 2005 dealing with infection control measures for prevention of CR-BSI were evaluated in order to identify evidence for the possible modification of routine practice. Special emphasis was placed on randomized controlled trials (RCTs), meta-analyses or systematic reviews, and studies applying multi-module interventions. Thirty-three RCTs and 10 meta-analyses or systematic reviews were retrieved. In addition, 10 cohort studies were identified where multi-module programmes were introduced for reducing CR-BSI rates. It was found that RCTs and meta-analyses only have a minor influence on the existing guidelines for the prevention of CR-BSIs and confirm the earlier recommendations on several points. Studies investigating multi-module programmes, however, found a substantial reduction in CR-BSIs ranging from 29% to 95%. The data show that many CR-BSIs are preventable and that there is room for improvement in many institutions. Simple interventions are often useful for reducing CR-BSI rates and the opportunities to decrease CR-BSI rates appear to be greatest when multi-module programmes are applied. An average reduction of more than 50% seems to be possible.

Bacteremia↗
PubMed2001

Factors associated with acceptance and full publication of GI endoscopic research originally published in abstract form.

BACKGROUND: Many abstracts submitted to annual scientific meetings never come to full publication in peer-reviewed journals. The objective of this study was to determine factors associated with the fate of endoscopic research abstracts submitted to the annual scientific meeting of the American Society for Gastrointestinal Endoscopy (ASGE). METHODS: All abstracts (n = 461) submitted to the annual meeting of the ASGE in May of 1994 were retrospectively reviewed. The following databases were searched for evidence of publication of abstracts in full-manuscript form: Medline, HealthSTAR, Current Contents, CINHAL, and Cancerlit. All abstracts were reviewed between May 4, 1998 and June 30, 1998. Univariate and multivariate analysis were performed to determine the association between abstract characteristics and acceptance for presentation at the meeting and for publication. RESULTS: Fifty-five percent (247/451) of submitted abstracts were accepted for presentation. In univariate analysis, pediatric studies, prospective studies, randomized studies, and studies from university-affiliated medical centers (UAMC), were more likely to be accepted for presentation (p < 0.05). In multivariate analysis, the variables: pediatric studies (p = 0.01), prospective studies (p = 0.005), randomized studies (p = 0.06), and studies from UAMC (p = 0.01) predicted acceptance of abstracts for presentation at the meeting. The overall publication rate was 25.1%. The publication rates 1, 2, 3, and 4 years after the meeting were 6.7%, 16.2%, 22.8%, and 25.1%, respectively. Multivariate Cox proportional hazards analysis showed that accepted abstracts (p = 0.0003) studies reporting positive results (p = 0.0015), and studies from outside the United States (p = 0.036) were more likely to be published in manuscript form. CONCLUSIONS: The overall publication rate of abstracts reporting endoscopic research is 25%, lower than that in any published report from other medical societies. Abstracts from the United States were less likely to be published in full-manuscript form. Although there was no positive outcome bias for acceptance of abstracts for presentation at the meeting, there was bias toward publication of statistically significant results. Further investigations are warranted to determine the variation in the publication of research results according to country of origin and to determine factors that hinder publication of GI endoscopic research in manuscript form.

Abstracting and Indexing↗
PubMed1998

Sociodemographic representation in published studies of cocaine abuse pharmacotherapy.

This study evaluated: (1) the reporting of sociodemographic characteristics of research subjects in published outpatient studies of cocaine abuse pharmacotherapy; (2) the association of study characteristics with such reporting and with the distribution of characteristics; and (3) the comparison of sociodemographic characteristics in the research subjects with those of a community-based sample of cocaine abusers who had sought treatment. Medline search identified 68 articles on cocaine abuse outpatient pharmacotherapy published from 1983 to 1993 in an English language, peer-reviewed journal. Sociodemographic characteristics of research subjects (n = 1802) were compared with those of respondents (weighted n = 135) to the National Comorbidity Survey (1990-1992), who reported at least one cocaine-related problem and had sought substance abuse treatment. Only three (4.4%) articles reported all six of the following sociodemographic characteristics of their subjects: 82.4%, reported mean age; 58.8%, race/ethnicity; 85.3%, sex; 22.1%, employment status; 13.2%, educational status; and 5.9%, socioeconomic status/income. Compared to survey respondents, research subjects were significantly more likely to be African-American and live in the Northeast region of the US and marginally more likely to be male and currently unemployed. These findings indicate that many published articles do not follow currently recommended guidelines for describing sociodemographic characteristics of research subjects and that, aside from race/ethnicity and geographic location, research subjects are fairly comparable in basic sociodemographic characteristics to the larger population of treatment-seeking individuals with cocaine-related problems.

Adult↗
PubMed2002

Patient adherence to HIV medication regimens: a review of published and abstract reports.

A literature search was conducted to collect published articles reporting correlates of HIV medication adherence or interventions designed to increase HIV medication adherence. Proceedings from seven HIV/AIDS-related conferences were searched for relevant abstracts. We found 18 descriptive studies in published articles and 57 in conference proceedings producing over 200 separate variables falling into four broad areas: (1) factors related to treatment regimen; (2) social and psychological factors; (3) institutional resources; and (4) personal attributes. More complex regimens were related to decreased adherence, but were often successfully mitigated by regimen aids. Social and psychological factors reflecting emotional adjustment to HIV/AIDS and provider support were related to adherence. Access to institutional resources was associated with better adherence. Personal attributes showed a mixed relationship; gender was not consistently related to adherence, but younger age, minority status, and a history of substance abuse were often related to non-adherence. The intervention search yielded 16 interventions employing a wide range of behavioral, cognitive and affective strategies. Evidence of effectiveness was weak. We conclude the abstracts are a useful source of information as part of a systematic review, particularly when available published literature is limited, if results and study characteristics are reported in an adequate and standard manner.

Adult↗
PubMed1999

Can the published data tell us about the effectiveness of neoadjuvant chemotherapy for locally advanced cancer of the uterine cervix?

The effect of neoadjuvant chemotherapy on survival of patients with locally advanced cervical cancer was investigated by conducting a systematic review and meta-analysis of the published data. Of the 21 randomised trials that we identified, only 15 were published. Furthermore, 2-year survival data could be extracted from only seven trial reports and 3-year survival from only nine trial reports. Meta-analyses of the published data at 2 and 3 years are neither clearly in favour of neoadjuvant chemotherapy nor control (2 years: odds ratio (OR) = 1.09, 95% confidence interval (CI) = 0.83-1.45, P = 0.37; 3 years: OR = 0.96, 95% confidence interval (CI) = 0.73-1.25, P = 0.45). Being restricted to only some of the data from a relatively small fraction of the randomised trials, these analyses potentially suffer from a number of biases and are therefore inconclusive. The only reliable way to judge the value of neoadjuvant chemotherapy in this disease is to perform a meta-analysis of centrally collected, updated, individual data on all patients from all known randomised trials. Such an analysis is currently being carried out by an international collaborative group.

Antineoplastic Combined Chemotherapy Protocols↗
PubMed2006

Who publishes in leading general surgical journals? The divide between the developed and developing worlds.

BACKGROUND: Most articles in top general surgical journals seem to originate from a limited few developed countries. The purpose of this study was to establish which countries publish the most in leading general surgical journals. METHODS: We analysed all the studies, reviews and case reports published in 2003-2004 in 10 leading English-language general surgical journals with the highest impact factors to obtain country-wise data with regard to the origin of articles. Editorials, historical articles, commentaries, guidelines, biographies, interviews and letters to editors were excluded from the analysis. RESULTS: A total of 5,081 articles were reviewed. Out of these, 834 were excluded as detailed above and the remaining 4,247 articles were analysed. Most of these were from USA, European countries, Japan, and Australia. It seems that the vast majority of the world's population living in the developing countries do not find adequate representation in leading general surgical journals. CONCLUSION: Very few articles are published from developing countries in leading general surgical journals. Both developing countries and medical journals need to take steps to curb this trend. Steps are suggested to improve the situation so that the developing world is also adequately represented in the surgical literature.

Authorship↗
PubMed2001

Clinical crown height (length)--a review of published measurements.

BACKGROUND, AIMS: Clinical crown height is an objective measure of the position of the gingival margin which could be used in determining the 'normal' position of the gingival margin. The aim of this study was to do a systematic review of published clinical crown heights in the human permanent dentition to compare the measurements and to see if a clear trend with age exists. MATERIAL AND METHODS: An on-line literature search was done using the key words clinical crown height (or) clinical crown length. From January 1975 to August 2000, 11 published papers have listed measurements; three of these report on all tooth types, the remainder on anterior teeth. RESULTS: All studies used the same measuring technique but age group reporting differed as did the tooth types measured. Measurements from the 10 acceptable studies of the clinical crown height of the same teeth are comparable at similar ages, so published values are reasonable estimates of 'normality' for diagnosis. There is a statistically significant increase in clinical crown height of central and lateral incisors with age that slows as age increases.

Age Factors↗
PubMed1995

Adjuvant chemotherapy for soft-tissue sarcoma: review and meta-analysis of the published results of randomised clinical trials.

Fifteen published randomised trials comparing adjuvant chemotherapy with no chemotherapy in soft-tissue sarcoma (STS) were identified (1546 patients). A qualitative review and a meta-analysis of this published literature were performed. With the qualitative review it was not possible to synthesise the apparently conflicting results of individual trials. The meta-analysis of the published data suggests an improvement in survival at 2 years (OR = 0.73, 95% CI = 0.53-0.99, P = 0.044) and at 5 years (OR = 0.59, 95% CI = 0.45-0.78, P = 0.0002) in favour of chemotherapy. However, the assumptions and approximations required to conduct this quantitative summary demand that the results are interpreted with caution. The only reliable means of assessing the current evidence on whether adjuvant chemotherapy has a role in the treatment of patients with STS, is to collect, check and reanalyse individual patients data (IPD) from each trial centrally, and formally combine the results in a stratified time-to-event analysis. Such an IPD analysis is currently being undertaken by an international collaborative group.

Adult↗
PubMed2002

Measuring the outputs of Australian nursing research published 1995-2000.

AIMS: To analyse the research published in refereed nursing journals by Australian authors from 1995 to 2000. BACKGROUND: Analysis of the research topics and types of methodologies used by Australian nurse researchers has not been recently undertaken. The study was similar to an analysis of United Kingdom (UK) nursing research between 1988 and 1995 to allow comparison between the two countries. DESIGN: A quantitative approach analysed the research abstracts for the topic researched, source of data, location of data collection, paradigm and methodology used and funding source. RESULTS: A total of 509 articles from 11 generalist Australian and UK nursing journals were analysed. The highest numbers of articles were published in Australian Journal of Advanced Nursing and Journal of Advanced Nursing. The most popular topics were education of nurses (18.7%, n=95) and practice issues relating to patient care (15.3%, n=78). However, scant attention was paid to major Australian health issues. Most research was undertaken in the hospital setting (55.8%, n=247). Data were most often drawn from nurses themselves (40.7%, n=206), followed by patients (25.5%, n=129). Both quantitative (41%, n=203) and qualitative approaches (47%, n=230) were employed. A minority of studies acknowledged any funding (14.9%, n=76). CONCLUSIONS: Research findings need to be applied in practice to improve patient care. Nurse researchers need to publish their findings and align their research interests to meet national health priorities. They need to be involved in setting these health priorities to ensure that nursing has a place in health research.

Australia↗
PubMed2003

Fetal transcerebellar diameter nomogram in singleton gestations with special emphasis in the third trimester: a comparison with previously published nomograms.

OBJECTIVE: This study was undertaken to construct an institution-specific transverse cerebellar (transcerebellar) diameter nomogram with special emphasis in the third trimester and to compare its ability to predict gestational age with previously published nomograms. STUDY DESIGN: A cross-sectional nomogram was constructed using transcerebellar diameter measurements in 24,026 well-dated singleton fetuses by using linear regression models. Third-trimester measurements from 2,010 fetuses were included. The performance of previously established transcerebellar diameter nomograms for predicting gestational age was assessed in our population to determine comparability between nomograms. RESULTS: Interobserver and intraobserver variabilities in the second and third trimesters were 3.1% to 3.7% and 3.4% to 3.8%, respectively. Between 14 and 27 weeks' gestation, there were no clinically important differences between our nomogram and those previously published in terms of the predicted gestational age. However, predicted gestational age in the third trimester was considerably different by using our nomogram by 1 to 2 weeks from 28 to 30 weeks and by 4 to 6 weeks after 32 weeks. CONCLUSION: Transcerebellar measurements had a similar relationship with gestational age across previously published nomograms before 28 weeks. However, clinically significant differences in predicting gestational age appear later, especially after 32 weeks. These findings suggest that this new nomogram may be particularly useful for accurate dating of pregnancies in the third trimester.

Cerebellum↗
PubMed2001

A meta-analysis of the published research on the effects of child sexual abuse.

A meta-analysis of the published research on the effects of child sexual abuse (CSA) was undertaken for 6 outcomes: posttraumatic stress disorder (PTSD), depression, suicide, sexual promiscuity, victim-perpetrator cycle, and poor academic performance. Thirty-seven studies published between 1981 and 1995 involving 25,367 people were included. Many of the studies were published in 1994 (24; 65%), and most were done in the United States (22; 59%). All six dependent variables were coded, and effect sizes (d) were computed for each outcome. Average unweighted and weighted ds for each of the respective outcome variables were .50 and .40 for PTSD, .63 and .44 for depression, .64 and .44 for suicide, .59 and .29 for sexual promiscuity, .41 and .16 for victim-perpetrator cycle, and .24 and .19 for academic performance. A file drawer analysis indicated that 277 studies with null ds would be required to negate the present findings. The analyses provide clear evidence confirming the link between CSA and subsequent negative short- and long-term effects on development. There were no statistically significant differences on ds when various potentially mediating variables such as gender, socioeconomic status, type of abuse, age when abused, relationship to perpetrator, and number of abuse incidents were assessed. The results of the present meta-analysis support the multifaceted model of traumatization rather than a specific sexual abuse syndrome of CSA.

Child↗
PubMed2005

The economic impact of uterine fibroids in the United States: a summary of published estimates.

OBJECTIVE: To present a summary of published estimates of the economic burden of uterine fibroids in the United States and identify areas for additional research. METHODS: A search of three electronic databases, MEDLINE, EMBASE, and Current Contents, was conducted, along with a review of information on the Internet and abstraction of economic data. RESULTS: Only 10 papers and 1 Internet document met our inclusion criteria and were used to abstract data. Cost estimates for surgically invasive treatments of uterine fibroids included hysterectomy (USD 5,012-7,934), myomectomy (USD 5,425-11,839), and uterine artery embolization (UAE) (USD 5,425-7,645) (2004 USD). One cost-effectiveness study estimated lower costs and higher quality-adjusted life years with UAE compared with hysterectomy. A second study estimated potential savings of USD 4.2 million in hospital charges in the United States if higher rates of vaginal (vs. abdominal) hysterectomy would be achieved after pretreatment with gonadotropin hormone-releasing hormone (GnRH) agonists compared to without pretreatment with GnRH agonists (80% vs. 13%). There were no estimates of the total direct and indirect economic burden of uterine fibroids. Neither estimates of the costs for the ambulatory care of fibroids nor studies estimating the indirect costs associated with the management of fibroids and their symptoms were found. CONCLUSIONS: This summary of published U.S. economic estimates shows that despite the high prevalence of fibroids and their impact on clinical practice and women's lives, there is very little published information on their economic impact apart from data showing standard treatments for uterine fibroids are invasive and expensive. Reduction in the need for and cost of invasive procedures by the increased usage of noninvasive treatments could potentially achieve significant national cost savings, but further clinical and economic studies are needed.

Antineoplastic Agents, Hormonal↗
PubMed2006

Inaccessible novel questionnaires in published medical research: hidden methods, hidden costs.

Although critical analysis of survey research is limited when reviewers and readers cannot view a study's questionnaire, access to novel questionnaires used in published research has not been systematically examined. The authors identified publications reporting the results of novel questionnaires in three medical journals (JAMA, The New England Journal of Medicine, and The Lancet) in January 2000-May 2003 and searched portable document format (PDF) versions of the studies for the complete questionnaire or a Uniform Resource Locator (URL) providing access to the questionnaire. When the questionnaire was not provided in the publication or a published URL, the authors requested it from the corresponding author in writing up to three times over a 6-week period. Of 93 publications with novel questionnaires, four printed the questionnaire in the article and three provided online access. Corresponding authors failed to provide questionnaires for 37 of 81 (46%) studies. Novel questionnaires used in published research are frequently not available to readers or researchers. Policies that improve access to novel questionnaires will allow better assessment of study results, reduce duplicated efforts, and improve authorship attribution for questionnaire design.

Access to Information↗
PubMed1998

Response rate in patient satisfaction research: an analysis of 210 published studies.

OBJECTIVES: To examine the quality of response rate reporting and to identify methodological factors influencing response rates in published patient satisfaction studies. DESIGN: Examination and analysis of 210 studies from 200 papers published in 1994 in 141 different health journals. Papers were located in the following databases: British Nursing Index, CINAHL, EMBASE, MedLine, Popline, and PsycLIT. MAIN MEASURES: Reported and calculated response rates, collection and recruitment procedures of published studies, and type of instruments used for data collection. RESULTS: Forty-eight per cent of studies reported a response rate. The mean response rate was 72.1%. There was no association between response rate and the type of instrument used for data collection. Studies which used a face-to-face approach to either subject recruitment (mean response rate, 76.7%) or data collection (mean response rate, 76.9%) were associated with significantly higher response rates than those in which subjects were recruited by mail (mean response rate, 66.5%) or data were collected by mail (mean response rate, 67%). Response rate was not related to questionnaire length. CONCLUSION: Patient satisfaction studies generally show poor awareness of the importance of methodological issues relevant to response rate. Far more attention to this aspect is needed if findings in this field are to be accepted as valid and useful.

Australia↗
PubMed2001

yMGV: a database for visualization and data mining of published genome-wide yeast expression data.

The yeast Microarray Global Viewer (yMGV) is an on-line database providing a synthetic view of the transcriptional expression profiles of Saccharomyces cerevisiae genes in most of the published expression datasets. yMGV displays a one-screen graphical representation of gene expression variations for each published genome-wide experiment, allowing quick retrieval of experimental conditions affecting expression of this gene. yMGV also provides tools to isolate groups of genes sharing similar transcription profiles in a defined subset of experiments. Additionally, yMGV furnishes a set of statistical tools for critical assessment of published data. We therefore believe that yMGV is an efficient tool that affords a quick and comprehensive overview of microarray data and generates new gene classifications. As of 20 March 2001 the yMGV database contains 6 000 000 measurements, representing genome-wide expression comparisons of 932 experiments from 39 microarray publications. The yMGV interface is available at http://transcriptome.ens.fr/ymgv/.

Computational Biology↗
PubMed2005

HuSiDa--the human siRNA database: an open-access database for published functional siRNA sequences and technical details of efficient transfer into recipient cells.

Small interfering RNAs (siRNAs) have become a standard tool in functional genomics. Once incorporated into the RNA-induced silencing complex (RISC), siRNAs mediate the specific recognition of corresponding target mRNAs and their cleavage. However, only a small fraction of randomly chosen siRNA sequences is able to induce efficient gene silencing. In common laboratory practice, successful RNA interference experiments typically require both, the labour and cost-intensive identification of an active siRNA sequence and the optimization of target cell line-specific procedures for optimal siRNA delivery. To optimize the design and performance of siRNA experiments, we have established the human siRNA database (HuSiDa). The database provides sequences of published functional siRNA molecules targeting human genes and important technical details of the corresponding gene silencing experiments, including the mode of siRNA generation, recipient cell lines, transfection reagents and procedures and direct links to published references (PubMed). The database can be accessed at http://www.human-siRNA-database.net. We used the siRNA sequence information stored in the database for scrutinizing published sequence selection parameters for efficient gene silencing.

Base Sequence↗
PubMed2003

Clinical trials in orthodontics I: demographic details of clinical trials published in three orthodontic journals between 1989 and 1998.

AIM: To test the hypothesis that there is insufficient evidence available, from clinical trials, to allow evidence-based decisions to be made on the effectiveness of orthodontic treatment. OBJECTIVES: To identify reports of orthodontic clinical trials and assess their demographic characteristics. DESIGN: A retrospective, observational study. SETTING: The American Journal of Orthodontics and Dentofacial Orthopedics, British Journal of Orthodontics, and European Journal Orthodontics. DATA SOURCE: Clinical trials published between 1989 and 1998. METHOD: A hand-search was performed to identify all clinical trials. The journal and year of publication, research method, interventions, and sample size of the trials reported were recorded. RESULTS: One-hundred-and-fifty-five trial reports were identified of which 56 (36.1%) were published from 1989 to 1993 and 99 (69%) from 1994 to 1998. Ninety-nine (69%) reports were published in the AJO-DO, 18 (11.6%) in the BJO and 38 (24.5%) in the EJO. Eighty-five (54.8%) were reports of randomized controlled trials and 70 (45.2%) of controlled clinical trials. The interventions most frequently assessed were bonding materials (21.9%), growth modification treatments (21.3%), and oral hygiene procedures (9.0%). The median sample size was 32 (IQR 19.5, 50). CONCLUSION: There is sufficient evidence available from clinical trials to warrant doing systematic reviews of orthodontic clinical trials to aid decision-making.

Controlled Clinical Trials as Topic↗