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Who is blinded in randomized clinical trials? A study of 200 trials and a survey of authors.

BACKGROUND: Insufficient blinding of persons involved in randomized clinical trials is associated with bias. The appraisal of the risk of bias is difficult without adequate information in trial reports. PURPOSE: We wanted to study how blinding is reported in clinical trials and how lack of reporting relate to lack of blinding. METHODS: A cohort study of 200 blinded randomized clinical trials published in 2001 randomly sampled from the Cochrane Central Register of Controlled Trials, and a questionnaire survey of the trial authors. RESULTS: One-hundred and fifty-six (78%) articles described trials as 'double blind'. In three (2%) of such articles the blinding status of patients, health care providers and data collectors was explicitly described. Eighty-eight (56%) articles did not describe the blinding status of any trial person, and 41 articles (26%) reported no blinding relevant information at all beyond the trial being 'double blind'. One-hundred and thirty (65%) surveyed authors responded. Patients were blinded in 101 (97%) 'double blind' trials, and health care providers in 93 (89%). Twenty (19%) 'double blind' trials had not blinded either patients, health care providers or data collectors. Survey responders provided 15 different operational meanings of the term 'double blind', and typically felt that their preferred definition was the most widely used. LIMITATIONS: The proportions in the author survey may be too optimistic due to reporting bias. It is not known how the increased use of the CONSORT guidelines may have affected reporting in years after 2001. CONCLUSIONS: The blinding status of key trial persons was incompletely reported in most randomized clinical trials. Unreported blinding may be frequent, but one of five 'double blind' trials did not blind either patients, treatment providers or data collectors. Authors, referees, and journal editors could improve the completeness of reporting of blinding, eg, by adhering to the CONSORT statement. It is inappropriate to presume blinding of key trial persons based only on the ambiguous term 'double blind'.

Double-Blind Method↗

An icon in distress ponders the future: compete or collaborate? IBM. Interview by William Andrew.

Bureaucratic, buttoned-down, big-box-based IBM, reeling from a record $5 billion loss in 1992, free-falling stock value, a $77 billion market value slide since 1978, layoffs that could downsize the giant firm from 406,000 employees in 1986 to 235,000 in 1993, now limps away from the 8-year era of CEO John Akers. His yet-to-be-announced replacement, for what many people call the single most difficult job in the country, will inherit a set of heritage-based problems that might send even Lee Iaccoca running for cover. In an exclusive interview with Scott Roeth, Health Industry Marketing Director, IBM UNited States, contributing editor William Andrew, P.E., posed the following questions regarding IBM's commitment to the healthcare marketplace. Roeth's answers may prove insightful for HI's readers.

Computer Systems↗

SEQGEL: a versatile and comfortable DNA editor which supports a special keyboard and a speech synthesizer.

A DNA editor for an Apple II is described which contains many additional functions apart from just editing sequences. The data files are normal ASCII text or binary files and can thus be used easily by other programs. The program supports a special keyboard which greatly facilitates typing of DNA sequences. Furthermore a speech synthesizer is supported by the editor. The speech feedback, together with the special keyboard, reduces typing errors to a minimum.

Base Sequence↗

[Information system in primary health care].

The Croatian Ministry of Health started a health care system computerization project aimed at strengthening the collaboration among health care institutions, expert groups and individual health care providers. A tender for informatic system for Primary Health Care (PHC) general practice, pediatrics and gynecology, a vital prerequisite for project realization, has now been closed. Some important reasons for undertaking the project include rationalization of drug utilization, savings through a reduced use of specialists, consultants and hospitalization, then achievement of better cooperation, work distribution, result linking, data quality improvement (by standardization), and ensuring proper information-based decision making. Keeping non-standardized and thus difficult to process data takes too much time of the PHC team time. Since, however, a vast amount of data are collected on only a few indicators, some important information may remain uncovered. Although decisions made by health authorities should rely on evidence and processed information, the authorities spend most of the time working with raw data from which their decisions ultimately derive. The Informatic Technology (IT) in PHC is expected to enable a different approach. PHC teams should be relieved from the tedious task of data gathering and the authorities enabled to work with the information rather than data. The Informatics Communication Technology (ICT) system consists of three parts: hardware (5000 personal computers for work over the Internet), operative system with basic software (editor, etc.), and PHC software for PHC teams. At the national level (National Public Health Informatics System), a software platform will be built for data collection, analysis and distribution. This data collection will be based on the International Classification of Primary Care (ICPC-2) standard to ensure the utilization of medical records and quality assessment. The system permits bi-directional data exchange between a central database and sources at different levels, across the spectrum from basic PHC teams to local authorities. This will enable data collection control, comparisons with national averages and prompt distribution of information over the Internet. The investment into IT is a strategic imperative having no alternative. A cost/benefit analysis has shown its operation in the PHC system to return the investment in two years. As defined according to the Project priorities (with measurable objectives), the use of new technologies will be introduced by stages.

Croatia↗

Specific dermatoses of pregnancy: an evidence-based systematic review.

OBJECTIVE: We conducted an evidence-based systematic analysis of the literature on specific dermatoses of pregnancy. STUDY DESIGN: The bibliographic databases MEDLINE and EMBASE were screened for studies and reports in all languages about herpes gestationis, pruritic urticarial papules and plaques of pregnancy, pruritic folliculitis of pregnancy, and prurigo of pregnancy from January 1962 to January 2002. As main index terms, including analogs and derivatives, we used the names of specific dermatoses of pregnancy. Intrahepatic cholestasis of pregnancy, not a primary dermatosis, was included herein because this disorder is associated with pregnancy and its secondary skin manifestations must be differentiated from specific dermatoses of pregnancy. Other sources were abstract books of symposia and congresses, theses, textbooks, monographs, reviews, editorials, letters to the editor, free or rapid communications, and the reference lists from all the articles that were retrieved. All articles selected for inclusion in this review were evaluated critically with regard to their impact factor and evidence-based contribution to this field, as measured by their citation index and impact factor of the journal in which they were published. Approximately 39% of articles met the selection criteria. RESULTS: The clinical features and prognosis of the specific dermatoses of pregnancy have been delineated through a number of retrospective and cohort studies. The molecular biologic and immunogenetic properties of herpes gestationis, pruritic urticarial papules and plaques of pregnancy, and intrahepatic cholestasis of pregnancy have been further clarified. A meta-analysis in this review reveals a higher prevalence of multiple gestation pregnancy (11.7%) among patients with pruritic urticarial papules and plaques of pregnancy. Several investigations have unraveled the fetal complications in intrahepatic cholestasis of pregnancy and herpes gestationis. New treatment modalities in intrahepatic cholestasis of pregnancy (cholestyramine, ursodeoxycholic acid) and herpes gestationis (cyclosporin, intravenous immunoglobulin, and tetracyclines postpartum) have shown promise and warrant further evaluation. CONCLUSION: During the past few decades, a significant amount of new data has provided new insights into the classification, pathogenesis, treatment, prognosis, and fetal risks that are associated with the specific dermatoses of pregnancy.

Cholestasis, Intrahepatic↗

Estimating intervention effectiveness: synthetic projection of field evaluation results.

In a 46-site, 5-year high-risk youth substance abuse prevention evaluation, effect sizes were adjusted using a meta-analytic regression technique to project potential effectiveness under more optimal research and implementation conditions. Adjusting effect size estimates to control for the impact of comparison group prevention exposure, service intensity, and coherent program implementation raised the mean effectiveness estimate from near zero (.02, SD = .21) to .24 (SD = .18). This finding suggests that adolescent prevention programs can have significant positive effects under optimal, yet obtainable conditions. EDITORS' STRATEGIC IMPLICATIONS: The authors present a meta-analytic technique that promises to be an important tool for understanding what works in multi-site community-based prevention settings. Researchers will find this to be a creative approach to model the "noise'' in implementation that may often overshadow the potential impact of prevention programs.

Adolescent↗

Reporting of instrument validity and reliability in selected clinical nursing journals, 1989.

Before research findings are applied to practice, the quality of the research must be assessed so that flawed research does not lead inadvertently to flawed practice. Two critical indicators of research quality are the validity and reliability of the data collection instruments. This article summarizes the principles of instrument validity and reliability and identifies deviations from these principles in a random sample of 55 research studies published in 1989 in five refereed nursing journals targeted toward practicing clinicians. Using a valid and reliable instrument, the investigators found that even with a policy of giving authors "the benefit of the doubt," 47% of the research studies contained no evidence of validity for any data collection instruments and 36% had no evidence of reliability; 29% had no evidence of either validity or reliability. Content validity, a basic requirement for all research instruments, was addressed in only 27% of the studies. This article provides documentation, justification, and suggestions for nursing educators, journal editors, and researchers to take action to improve the reporting of instrument validity and reliability to help ensure the quality of the research on which nursing practice is based.

Clinical Nursing Research↗

SEAVIEW and PHYLO_WIN: two graphic tools for sequence alignment and molecular phylogeny.

SEAVIEW and PHYLO_WIN are two graphic tools for X Windows-Unix computers dedicated to sequence alignment and molecular phylogenetics. SEAVIEW is a sequence alignment editor allowing manual or automatic alignment through an interface with CLUSTALW program. Alignment of large sequences with extensive length differences is made easier by a dot-plot-based routine. The PHYLO_WIN program allows phylogenetic tree building according to most usual methods (neighbor joining with numerous distance estimates, maximum parsimony, maximum likelihood), and a bootstrap analysis with any of them. Reconstructed trees can be drawn, edited, printed, stored, evaluated according to numerous criteria. Taxonomic species groups and sets of conserved regions can be defined by mouse and stored into sequence files, thus avoiding multiple data files. Both tools are entirely mouse driven. On-line help makes them easy to use. They are freely available by anonymous ftp at biom3.univ-lyon1.fr/pub/ mol_phylogeny or http:@acnuc.univ-lyon1.fr/, or by e-mail to galtier@biomserv.univ-lyon1.fr.

Animals↗

Cesarean delivery for fetal distress: rate and risk factors.

UNLABELLED: The objective of this article was to review the recent English language literature on cesarean delivery for fetal distress to determine its incidence, diagnostic tests, and the contributing factors to this obstetric complications. A PubMed search (1990-2000) with items of "cesarean, fetal distress," "cesarean, non-reassuring fetal heart rate," "cesarean, neonatal acidosis," and "cesarean, umbilical arterial pH," was undertaken. Reports, letters to the editor, focus on anomalous fetuses, and papers not specifically focused on this topic were excluded. Of the 392 articles that the search yielded, 169 met the inclusion criteria. Based on 37 reports with more than 1,000 patients each, the overall risk of prompt cesarean delivery for fetal concern was 3.1% (43,340 of 13,989,74). The risk exceeded 20% in patients with moderate/severe asthma, severe hypothyroidism, severe preeclampsia, and postterm or fetal growth restricted fetuses with abnormal Doppler studies. Use of likelihood ratios suggests that Doppler of the umbilical artery is a superior diagnostic test to amniotic fluid index in identifying parturients at risk for cesarean for non-reassuring fetal heart rate tracing. Although several risk factors increase the need for cesarean delivery for fetal distress, in general, most are unpreventable. TARGET AUDIENCE: Obstetricians & Gynecologists, Family Physicians. LEARNING OBJECTIVES: After completion of this article, the reader will be able to estimate the incidence of cesarean delivery for non-reassuring fetal heart rate tracing, outline potential diagnostic tests that are useful for the detection of fetal distress, and summarize medical and obstetric conditions that place patients at risk for cesarean delivery for fetal distress.

Adult↗

Relationship between conflicts of interest and research results.

CONTEXT: To date, research regarding the influence of conflicts of interest on the presentation of findings by researchers has been limited. OBJECTIVE: To evaluate the sources of funding for published manuscripts, and association between reported findings and conflicts of interest. METHODS: Data from both print and electronic issues of The New England Journal of Medicine (NEJM) and The Journal of the American Medical Association (JAMA) were analyzed for sources of funding, areas of investigation, conflict of interest (COI), and presentation of results. We reviewed all original manuscripts published during the year 2001 within NEJM (N = 193) and JAMA (N = 205). We use 3 definitions for COI in this paper: a broadly defined criterion, the criterion used by The International Council of Medical Journal Editors (ICMJE), and a criterion defined by the authors. RESULTS: Depending on the COI criteria used, 16.6% to 32.6% of manuscripts had 1 or more author with COI. Based on ICMJE criterion, 38.7% of studies investigating drug treatments had authors with COI. We observed a strong association between those studies whose authors had COI and reported positive findings (P <.001). When controlling for sample size, study design, and country of primary authors, we observed a strong association between positive results and COI (ICMJE definition) among all treatment studies (adjusted odds ratio [OR], 2.35; 95% confidence interval [CI], 1.08 to 5.09) and drug studies alone (OR, 2.64; 95% CI, 1.09 to 6.39). CONCLUSION: COI is widespread among the authors of published manuscripts and these authors are more likely to present positive findings.

Conflict of Interest↗

Continuing medical education with a personalized monthly newsletter.

The periodic newsletter is an approach to continuing medical education whose value is difficult to measure. A six-page monthly newsletter covering cancer and ambulatory medicine topics has been developed in two departments of a university medical center to meet perceived educational needs of new regional primary care practitioners and to maintain a helping relationship between university based and practicing physicians. The newsletter is sent free of charge to requesting clinicians. Each issue of the newsletter is introduced by a personalized letter signed individually by the editor. A reader survey was conducted to evaluate the interest of recipients and the content, usefulness, and format of the newsletter. A usable response rate of 76% was achieved. The evaluation documented that most readers found the publication useful in their practices, remembered receiving issues specifically, kept issues themselves after circulation to colleagues, and read the cover letter. Compared with conference or formal journal instructional methods of continuing medical education, a newsletter may consistently reach a larger audience at a fraction of the cost.

Education, Medical, Continuing↗

Stress and welfare: two complementary concepts that are intrinsically related to the animal's point of view.

The closely associated concepts of welfare and stress may be considered as opposites since welfare cannot be achieved under stress and vice versa. Stress was first considered as an unspecific response to any challenge taxing the organism's resources where the HPA axis plays a central role [Selye H. A syndrome produced by diverse nocuous agents. Nature 1936:32]. Along the same lines, welfare was considered as the state of an individual on a continuum between poor and good depending on the efforts required to adapt to the environment [Broom DM. Animal welfare: concepts and measurement. J Anim Sci 1991;69:4167-75]. However, these views cannot explain opposite results such as up- vs. down-regulation of the HPA axis and hypo- vs. hyper-behavioural reactivity under chronic stress. Later, it was shown that aversive situations trigger stress responses only if the individual perceives them as aversive. Mason [Mason JW. A re-evaluation of the concept of 'non-specificity' in stress theory. J Psychiatr Res 1971;8:323-33] suggested that the unspecificity of stress responses originates from a common emotion that produces them. Welfare has also been defined in terms of emotional states by Dawkins [Dawkins MS. Animal suffering, the science of animal welfare. London: Chapman and Hall Ltd.; 1980] and Duncan [Duncan IJH. Welfare is to do with what animals feel. J Agric Environ Ethics 1993;6:8-14]. Hence, both concepts are linked to mental states. Recent advances in psychology suggest that the very nature of an emotion results from a series of evaluations of the triggering situation that the individual makes based on criteria including novelty, predictability, controllability, and others [Scherer KR. Appraisal considered as a process of multi-level sequential checking. In: Scherer KR, Schorr A, Johnstone T, editors. Appraisal processes in emotion: theory, methods, research. New York: Oxford University Press; 2001. p. 92-120]. It is therefore suggested that the discrepancies found in the literature in terms of responses of the HPA axis or modification of behaviour under aversive conditions may stem from differences in the way a situation is evaluated. It is argued that stress comes from the animal's evaluation of the outcome of a situation, and that welfare is the state resulting from that evaluation.

Animal Welfare↗

Role-based access to patients clinical data: the InterCare approach in the region of Crete.

The basics of a particular Integrated Electronic Health Record (I-EHR) implementation are presented, as realised by the Patient Clinical Data Directory (PCDD) system. PCDD operates within the context of HYGEIAnet, the Integrated Healthcare Telematics Network of Crete. PCDD is based on a federation of autonomous information systems and provides to its authorized users alternative views of the health record as well as access and retrieval services to its geographically distributed segments. The data model of the PCDD is based on the Subjective Objective Assessment Plan (SOAP) model that originates from the primary healthcare domain. Access to detailed information on particular patients healthcare encounters is delivered via role-based authorization privileges and controls. The administration of the national healthcare organizations' business rules, for different user-groups, is made via a specially tailored and developed rule-editor.

Computer Security↗

The market made them do it. Participants in the Medicare Choices project say they're nudging out the insurance middleman--and insuring their own survival. Panel discussion.

Medicare is experimenting again. This time HCFA wants to figure out ways to expand managed care options for the elderly. Under the Medicare Choices Demonstration Project, hospitals and health systems are developing and testing alternatives to standard Medicare HMOs. Dick Davidson, president of the American Hospital Association, sees these pilot programs as the precursors to provider-sponsored organizations building up a base of knowledge about what it means to manage risk. The AHA recently convened a meeting of organizations involved in the demonstration project and asked Hospitals & Health Networks executive editor Alden Solovy to lead a panel discussion on the lessons being learned.

Aged↗

Letters to the editors.

Explore the source record for details and available documents.

Angiotensin-Converting Enzyme Inhibitors↗

[Recommendations for enhancing the quality of traditional Chinese medicine clinical research reporting].

Evidence based medicine (EBM) has drawn the attention of the medical community around the world and is rapidly becoming the standard in medical research. EBM requires both rigorous clinical trial research design, including adequate randomization and appropriate control, and accurate and thorough reporting of the findings of trials. Despite China's active research program, the majority of traditional Chinese medicine (TCM) clinical research in the Chinese literature fails to meet world standards of clinical research reporting, largely due to insufficient and inadequate reporting. Because of rising world demand for information on TCM research, enhancing the quality of research reporting in Chinese journals is imperative. Quality of reporting is important in all aspects of a manuscript, including the introduction/background, materials and methods, results, and discussion/conclusion sections. TCM journal editors, who serve as gatekeepers of quality, must encourage higher quality clinical research reporting by setting and upholding publication standards.

Biomedical Research↗

Creating values-based health care. An interview with ACMPE President Patty Brewster. Interview by Pamela L. Moore.

The new president of the American College of Medical Practice Executives (ACMPE), Patricia L. Brewster, FACMPE, regional director; Hughston Clinic, Atlanta, took time to talk to MGM Journal Managing Editor Pamela L. Moore, Ph.D., about her job, the ethics of medical practice management and the role of ACMPE. Brewster has 20 years experience in the medical marketplace. She formerly worked as the administrator at Phoenix: Orthopedic and Sports Medicine, Atlanta, and Orthopaedic Associates of Atlanta. She is also past-president of the MGMA Southern Section. Under her guidance, Hughston Clinic has from two to seven locations, covering a six county area in metropolitan Atlanta.

Ethics, Professional↗