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PubMed1989

Retrospective and prospective identification of unpublished controlled trials: lessons from a survey of obstetricians and pediatricians.

Investigations in which statistically significant differences between treatment groups have not been observed are less likely than others to be reported in scientific journals. In clinical research, this selective suppression of "negative" results may lead to the adoption of ineffective or hazardous treatments. In an attempt to obtain information about unpublished trials in perinatal medicine, letters were sent to 42,000 obstetricians and pediatricians in 18 countries. As a result, we were notified of 395 unpublished randomized trials. Only 18 of the trials had been completed more than 2 years before the survey, a period during which at least 2300 reports of perinatal trials had been published. Of the 395 unpublished trials, 125 had ceased recruitment within the 2 years prior to the survey, 193 were actively recruiting at the time of the survey, and 59 were about to begin recruitment. It was concluded that publication bias will not be addressed successfully by attempts to obtain information about unpublished trials retrospectively. However, since the response rate to our request for details about ongoing and planned trials was good, prospective registration of trials at inception appears to be a feasible approach to reducing publication bias and its adverse consequences. An additional merit of prospective registration of clinical trials is that it should reduce unnecessary duplication (as opposed to necessary replication) in research and promote more effective collaboration.

Clinical Trials as Topic↗

PubMed2005

Publication in otology and neuro-otology: dos and don'ts.

INTRODUCTION: Medical publication continues to be important to academicians, physicians in private practice, researchers and corporate sponsors. This article provides valuable dos and don'ts for authors. MATERIALS AND METHODS: Literature review and personal experience of the author. RESULTS: Advice is provided for understanding the publishing world, the peer-review process, duplicate publication, authorship, and dos and don'ts for successful authors. CONCLUSIONS: Publishing is a competitive art and science. The key to success is the submission of a proper manuscript that contains important, new, scientific information of value to the readers.

Humans↗

PubMed1980

Should health systems agencies be involved in environmental health planning?

Public Law 93-641 provides health systems agencies (HSAs) with a broad planning preview which has enabled a number of agencies to address environmental health issues in their health systems plans. Opponents of HSA involvement in environmental health planning charge that these activities overextend agency resources, duplicate efforts of other government agencies and involve HSAs in "issues of public policy." Closer examination of these charges finds them lacking in validity. The planning activities of health systems agencies are cooperative in nature, drawing upon the planning efforts of other institutions and agencies. It is illogical to exclude environmental concerns from general health planning in light of the impact of the environment upon health. Charges that issues of public policy are inappropriate topics for health planning are seen as attempts to avoid scrutiny of inconsistant legislative policies. Cooperative planning between health systems agencies and environmental health agencies is considered both desirable and essential for the development of effective health planning.

Environmental Health↗

PubMed2001

A comparison of the coverage of clinical medicine provided by PASCAL BIOMED and MEDLINE.

The bibliographic databases PASCAL BIOMED and MEDLINE, available both at SilverPlatter, were compared for their coverage of clinical medicine. The main objective of the study was to identify the information in PASCAL BIOMED that is supplementary to MEDLINE. In PASCAL BIOMED and MEDLINE 10 searches were performed, all limited to publication year 1996. Search profiles in PASCAL BIOMED were free text only, while in MEDLINE they were mainly composed of MeSH headings, with additional free text. Search results were analysed for numbers of (relevant) references retrieved, unique and duplicate references, precision and uniqueness ratio. Also the presence of abstracts in both databases, and the abstract language and the presence of English descriptors and identifiers in PASCAL BIOMED were studied. MEDLINE contained more relevant information than PASCAL BIOMED on nearly all topics studied. The precision of the PASCAL BIOMED searches varied from 29 to 87% (median = 68%) and of the MEDLINE searches from 20 to 91% (median = 66%). The uniqueness ratio in PASCAL BIOMED varied from 0 to 33% (median = 20%) and in MEDLINE from 28 to 83% (median 37%). Considering the numbers of relevant and unique references retrieved, MEDLINE performed better than PASCAL BIOMED. Yet a sizeable proportion of the relevant references were unique to PASCAL BIOMED. Probably PASCAL BIOMED would have performed better if lists of descriptors had been accessible in the database, preferably with support to trace them.

Clinical Medicine↗

PubMed2004

The role of measurement reliability in clinical trials.

One of the principal characteristics of an outcome measure in a clinical trial, and any measurement in general, is its reliability. Reliability refers to the reproducibility of the measurement when repeated at random in the same subject or specimen. Reliability is often confused with validity, which refers to the extent to which the variable properly measures the underlying trait of interest. The coefficient of reliability is an estimate of the proportion of all variation that is not due to measurement error and is readily estimated from replicate measurements. The reliability of a measurement determines its maximal correlation or R2 and slope (or effect size) in regression models, its sensitivity and specificity when used for classifications or predictions, and the power of a statistical test employing the measurement. All decline as the reliability of the measure declines. The reliability of a measurement is an important consideration in the choice of the primary outcome measure for a clinical trial and in the choice of measures used for assessment of eligibility and exclusion. Reliability of measures should be assessed and assured by a quality control program based on randomly selected duplicate assessments. Just as the power of a study is reported in a final publication, so also should the reliability of the outcome and eligibility measurements so as to allow the authors to better describe, and readers to better understand, the sources of imprecision in study results, and those who follow to improve the design of future trials.

Clinical Trials as Topic↗

PubMed2005

Effectiveness of erythropoietin in the treatment of patients with malignancies: methods and preliminary results of a Cochrane review.

Cancer and cancer therapy-associated anemia may have an impact on tumor response and overall survival. Additionally, anemia represents an important economic factor. Therefore, therapeutic alternatives such as erythropoietin (EPO) and red blood cell transfusions have to be evaluated systematically. The effectiveness of recombinant human EPO to prevent or alleviate anemia in patients with malignant disease was determined. Randomized controlled trials comparing prophylaxis or treatment of anemia with EPO plus red blood cell transfusion (RBCT) or RBCT only in patients with malignant disease undergoing antineoplastic therapy were included. The endpoints needed for RBCT were hematological response (hemoglobin increase of 2g/dL or hematocrit increase of 6%), tumor response, and overall survival. Medical databases (Cochrane Library, MEDLINE, EMBASE) and conference proceedings were searched (1985-2001). Full-text and abstract publications were included as well as unpublished data. Data extraction and quality assessment were done in duplicate. All authors were contacted to obtain missing data. Out of 33 eligible studies, 27 trials with 3,287 randomized patients were included.

Anemia↗

PubMedDate not supplied

Meta-analysis of clinical trials as a scientific discipline. I: Control of bias and comparison with large co-operative trials.

Meta-analysis is an important method of bridging the gap between undersized randomized control trials and the treatment of patients. However, as in any retrospective study, the opportunities for bias to distort the results are widespread. Attempts must be made to introduce the controls found in prospective studies by blinding the selection of papers and extraction of data and making blinded duplicate determinations. Informal and personalized methods of obtaining data are probably more liable to error and bias than employing only published data. Publication bias is a serious problem requiring further research. There also need to be more comparisons of meta-analysed small studies with large co-operative trials.

Adrenergic beta-Antagonists↗

PubMed1976

Effects of binding policy and other factors on the availability of journal issues.

Random samples of journal issues, derived from a test set of 106 biomedical journal titles, were checked against the shelves of the Woodward Biomedical Library under circulating and noncirculating conditions. As well as circulation, binding procedures and duplication of sets were seen to affect availability. Indications are that the practice of binding journals upon completion of the volume may remove them from use at a time of peak demand. The usefulness of second sets of journals appeared to decline rapidly within a few years after publication. A change from circulating to noncirculating conditions may have increased availability certain journals by discouraging use.

Bookbinding↗

PubMed1989

[Online patent searching--rapid responses to critical questions].

Online searching in publically available patent files opens up interesting possibilities to provide a rapid response to critical questions. A computerized analysis of all patents of leading German pharmaceutical companies over the last decade in important indication areas is described. Supported by subsequent manual processing of individual patents it is shown that duplicate experiments on animals practically never occur.

Chemical Phenomena↗

PubMed1999

[The International Network of Agencies for Health Technology Assessment (INAHTA) or the need for collaboration in evaluating health technologies].

Given the current situation of globalization, rapidity of changes and open market, the problems in the health care sector also go beyond the local boundary. Thus, it is frequent for different health systems to have similar evaluation needs. The assessment reports are among the main tools that assessment agencies use to communicate with the health care professionals and policy makers in any responsibility: politics, management, or clinical care. Occasionally different evaluation teams have to deal with similar topics. It is in this context, with the aim to avoid duplicity and to join efforts, that the idea of collaboration within assessment agencies started, with an obvious benefit to all of them. The International Network of Agencies for Health Technology Assessment (INAHTA) was created with the aim of serving as a forum to identify common interests of agencies for health technology assessment. In these five years, a lot of activities and important outcomes have been achieved. Among others, we can mention the implementation of data bases with all the information produced by the member agencies, the establishment of an Internet Web site, the periodical publication of the newsletter, the joint assessment projects and the collaboration with developing countries. New projects for the future are currently under discussion.

Cooperative Behavior↗

PubMed1993

A comprehensive compilation of 1001 nucleotide sequences coding for proteins from the yeast Saccharomyces cerevisiae (= ListA2)

The amount of nucleotide sequence data is increasing exponentially. We therefore continued our effort to make a comprehensive database for the yeast Saccharomyces cerevisiae. In this database (ListA2) we have compiled 1001 protein coding sequences from this organism. Each sequence has been attributed a single genetic name and in the case of allelic duplicated sequences, synonyms are given, if necessary. For the nomenclature we have introduced a standard principle for naming gene sequences based on priority rules. We have also applied a simple method to distinguish duplicated sequences of one and the same gene from non-allelic sequences of duplicated genes. By using these principles we have sorted out a lot of confusion in the literature and databanks. Along with the genetic name, the mnemonic from the EMBL databank, the codon bias, reference of the publication of the sequence and the EMBL accession numbers are included for each entry. The database is available on request.

Alleles↗

PubMed1999

Photographic imaging for esthetic restorative dentistry.

Patient dental records are the most critical component of every dental practice. Whether these records are maintained in traditional cardboard folders or as digital bytes of information, the completeness of their contents is important to successful patient care. Two trends are expanding the contents of the dental record to include photographs. One of these trends is the widespread interest in esthetic restorative dentistry and the other is the increasing level of expectations by the public. More than ever, patients are seeking dental treatment to alter the appearance of their teeth. Unfortunately, esthetic restorative dentistry often is not part of a formal dental education. In addition, esthetics is a subjective topic, and patient demands and expectations can easily exceed a dentist's skill and expertise. This can ultimately lead to an "unhappy patient syndrome" and cause conflict between the patient and the dental team. Sometimes this conflict can result in litigation, which is another reason that photographs are a valuable addition to the patient record. The information that is contained in a good-quality set of "before" and "after" photographs cannot be duplicated with other components of the dental record. Taking the time to assemble adequate baseline records is always critical before any patient care is initiated. In restorative dentistry, this includes the standard of care elements: a health history, soft-tissue examination, periodontal examination, teeth and restoration examination, study casts, and an adequate radiographic survey. The use of photography in dentistry has historically been limited to the field of orthodontics. It is the standard of care for orthodontic baseline records, but has not been mandated for restorative dentistry. Memories are rarely accurate about subtle details of one's appearance and people can easily forget what their original smiles looked like even though treatment time may only be a matter of days. Baseline photographs provide an irrefutable record of pretreatment conditions in correct context. More importantly, you do not have to be a dentist to interpret the general information that is displayed on a photograph. To gain additional perspective on this issue, we consulted a panel of three dentists who are well recognized for their expertise in dental esthetics and imaging.

Dental Equipment↗

PubMed2005

Evaluating meta-analyses in the general surgical literature: a critical appraisal.

OBJECTIVE: To assess the methodologic quality of meta-analyses of general surgery topics published in peer-reviewed journals. SUMMARY BACKGROUND DATA: Systematic reviews and meta-analysis are used to seek, summarize, and interpret primary studies on a given topic. Accordingly, systematic reviews and meta-analyses of high-quality primary studies may be the highest level of evidence for issues of prevention and treatment in evidence-based medicine. However, not all published meta-analyses are rigorously performed. METHODS: We searched MEDLINE (from January 1, 1997, to September 1, 2002) and reference lists and solicited general surgery specialists to identify relevant meta-analyses. Inclusion criteria were use of meta-analytic methods to pool the results of primary studies in general surgery on issues of diagnosis, causation, prognosis, or treatment. Our search strategies identified 487 potentially relevant articles. After excluding articles based on a priori criteria, 51 meta-analyses fulfilled eligibility criteria. In duplicate and independently, 2 reviewers assessed the quality of these meta-analyses using a 10-item index called the Overview Quality Assessment Questionnaire. RESULTS: Overall concordance between 2 independent reviewers was good (interobserver agreement 81%, and a kappa of 0.62 (95% CI 0.55-0.69). Of 51 relevant articles, 38 were published in surgical journals. Most studies had major methodologic flaws (median score of 3.3, scale of 1-7). Factors associated with low overall scientific quality included the absence of any prior meta-analyses publications by authors and meta-analyses produced by surgical department members without external collaboration. CONCLUSIONS: This critical appraisal of meta-analyses published in the general surgery literature demonstrates frequent methodologic flaws. The quality of these reports limits the validity of the findings and the inferences that can be made about the primary studies reviewed. To improve the quality of future meta-analyses, we recommend following guidelines for the optimal conduct and reporting of meta-analyses in general surgery.

General Surgery↗

PubMed2007

Establishing procedures for institutional oversight of stem cell research.

Academic health centers (AHCs), which are at the forefront of stem cell research, need to establish institutional stem cell research oversight committees (SCROs) to comply with 2005 National Academy of Sciences (NAS) recommendations and to establish public trust in this sensitive research. Institutional review boards (IRBs) typically lack the expertise and time to adequately review the specific ethical issues raised by stem cell research. To assure careful, timely, and coordinated review of the science and ethics of stem cell protocols, AHCs need to address many practical procedural issues, such as SCRO membership, quorum, conflicts of interest, and procedures for protocol review. The SCRO committee at the University of California San Francisco (UCSF), established in 2003, has developed detailed policies and procedures on these issues. The UCSF SCRO has broad scientific expertise and uses ad hoc reviewers to strengthen the review process. Studies receiving full SCRO review have three lead reviewers: a scientist, a reviewer with ethics expertise, and a public representative. Studies introducing human stem cells into nonhuman blastocysts receive full review, even if the stem cells are anonymized. Some protocols are eligible for expedited review. The SCRO neither replaces nor duplicates review by the IRB and institutional animal care and use committees. Other AHCs can draw on the UCSF experience when developing their own policies and procedures for stem cell research oversight.

Academic Medical Centers↗

PubMed2005

Newer antidepressants in pregnancy and rates of major malformations: a meta-analysis of prospective comparative studies.

BACKGROUND: A substantial number of women of childbearing age suffer from depression. Despite this, relatively little is known about the safety of antidepressant use during pregnancy. PURPOSE: We conducted a meta-analysis of prospective comparative cohort studies to quantify the relationship between maternal exposure to the newer antidepressants and major malformations. METHODS: We searched Medline, Embase and Reprotox from 1996 to the present for studies comparing outcomes in first trimester exposures to citalopram, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, reboxetine, venlafaxine, nefazodone, trazodone, mirtazapine and bupropion to those of non-exposed mothers. Data were combined using a random effects model; heterogeneity was tested with chi2, and publication bias with a funnel plot and the Begg-Mazumdar statistic. RESULTS: Twenty-two studies were identified, 15 were rejected (4 reviews, 4 without comparison groups, 2 third trimester exposures, 2 retrospective database studies, 2 case reports and 1 duplicate); 7 studies (n = 1774) met inclusion criteria. Effects were not heterogeneous (chi2 = 2.04, p = 0.92); funnel plot and test (tau = -0.24, p = 0.45) indicated no publication bias. The summary relative risk was 1.01 (95%CI: 0.57-1.80). CONCLUSIONS: As a group, the newer antidepressants are not associated with an increased risk of major malformations above the baseline of 1-3% in the population.

Abnormalities, Drug-Induced↗

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↗

PubMed1987

Acuerdo No. 401, 31 March 1987.

This Accord creates a National Women's Council as an advisory council to the Ministry of Social Welfare. The Council is to have the following functions: a) to propose national policies to solve the problems that impede the progress of Ecuadoran women; b) to coordinate work done in both the private and public sectors for women in order to avoid duplication of activities and make the best use of human and financial resources; c) to give advice to and support the activities of the National Directorate of Women, when required; and d) to collect and maintain permanently information on plans and programs promoting women that are executed on the national level in both the governmental and nongovernmental spheres.

Americas↗

PubMed2005

The use of mitomycin-C for respiratory papillomas: clinical, histologic and biochemical correlation.

OBJECTIVE: To assess the clinical effects of mitomycin-C (MMC) on human papilloma virus (HPV)-infected tissues of the airway. METHODS: We included 10 patients with previous histologic diagnosis of recurrent respiratory papillomas (RRP) in this prospective study, conducted at the Department of Otolaryngology-Head and Neck Surgery, University of Alexandria, Egypt, between January 2000 and December 2002. Under general anesthesia, each patient underwent laser excision of all visible papillomas, followed by topical application of 1 cc of 0.5 mg/ml MMC. The procedure was repeated weekly until no visible papillomas could be microscopically detected. We histopathologically studied the obtained specimens and tested for the presence of HPV DNA using polymerase chain reaction (PCR) technique. We collected blood samples from all patients and from another 10 healthy volunteers for determination of serum interleukin-2 (IL-2) level using enzyme-linked immunosorbent assay technique. RESULTS: We achieved clinical remission in 8 of the patients (80%), a fact that was confirmed histopathologically and by PCR data. The mean serum IL-2 levels+/- SD was significantly lower in papilloma patients (83.6+/- 28.83 pg/ml) than in control subjects (196.3+/- 42.46 pg/ml) (p<0.01). Among patients with RRP, serum IL-2 levels+/-SD was lower in initial samples (83.6+/- 28.83) than follow-up (95.7+/- 27.98 and 112.3+/- 33.8 and 129.4+/- 34.04) and remission samples (154+/- 37.84 pg/ml) CONCLUSION: Our result suggests that topical application of MMC may act adjunctively to laser surgery for RRP.

Adolescent↗