Science journal editors' views on publication ethics: results of an international survey.

BACKGROUND: Breaches of publication ethics such as plagiarism, data fabrication and redundant publication are recognised as forms of research misconduct that can undermine the scientific literature. We surveyed journal editors to determine their views about a range of publication ethics issues. METHODS: Questionnaire sent to 524 editors-in-chief of Wiley-Blackwell science journals asking about the severity and frequency of 16 ethical issues at their journals, their confidence in handling such issues, and their awareness and use of guidelines. RESULTS: Responses were obtained from 231 editors (44%), of whom 48% edited healthcare journals. The general level of concern about the 16 issues was low, with mean severity scores of <1 (on a scale of 0-3) for all but one. The issue of greatest concern (mean score 1.19) was redundant publication. Most editors felt confident in handling the issues, with <15% feeling "not at all confident" for all but one of the issues (gift authorship, 22% not confident). Most editors believed such problems occurred less than once a year and >20% of the editors stated that 12 of the 16 items never occurred at their journal. However, 13%-47% did not know the frequency of the problems. Awareness and use of guidelines was generally low. Most editors were unaware of all except other journals' instructions. CONCLUSIONS: Most editors of science journals seem not very concerned about publication ethics and believe that misconduct occurs only rarely in their journals. Many editors are unfamiliar with available guidelines but would welcome more guidance or training.

Technical editing of research reports in biomedical journals.

BACKGROUND: Most journals try to improve their articles by technical editing processes such as proof-reading, editing to conform to 'house styles' and grammatical conventions. Despite the considerable resources devoted to technical editing, we do not know whether it improves the accessibility of biomedical research findings or the utility of articles. OBJECTIVES: To assess the effects of technical editing on research reports in peer-reviewed biomedical journals. SEARCH STRATEGY: We searched the Cochrane Library Issue 1, 2001, MEDLINE (last searched February 2000), 12 other databases, handsearched 9 journals and checked relevant articles for further references. We also searched the Internet and contacted researchers and experts in the field. SELECTION CRITERIA: Prospective or retrospective comparative studies of technical editing processes applied to original research articles in biomedical journals. DATA COLLECTION AND ANALYSIS: Two reviewers independently assessed each study against the selection criteria and assessed the methodological quality of each study. One reviewer extracted the data, and the second reviewer repeated this. MAIN RESULTS: We located 18 studies addressing technical editing and 35 surveys of reference accuracy. Only two of the studies were randomized controlled trials. A 'package' of largely unspecified editorial processes applied between acceptance and publication was associated with improved readability in two studies and improved reporting quality in another two studies, while another study showed mixed results after stricter editorial policies were introduced. More intensive editorial processes were associated with fewer errors in abstracts and references. Providing instructions to authors was associated with improved reporting of ethics requirements in one study and fewer errors in references in two studies, but no difference was seen in the quality of abstracts in one randomized controlled trial. Structuring generally improved the quality of abstracts, but increased their length. The reference accuracy studies showed a median citation error rate of 39% and a median quotation error rate of 20%. AUTHORS' CONCLUSIONS: Surprisingly few studies have evaluated the effects of technical editing rigorously. However there is some evidence that the 'package' of technical editing used by biomedical journals does improve papers.

The TATGARAT box of the HSV-1 ICP27 gene is essential for immediate early expression but not critical for efficient replication in vitro or in vivo.

We constructed a recombinant virus containing a promoter mutation altering the immediate-early expression of the HSV-1 ICP27 transcript, ICP27DeltaSma, which contains a deletion of the "TATGARAT" and surrounding sequences, but retains the rest of the ICP27 promoter. This mutant does not exhibit immediate-early expression of ICP27 using criteria of expression in the absence of de novo protein synthesis and earliest expression in the kinetic cascade. While transcript abundance at 1h after infection at 0.1 PFU/cell in mouse embryo fibroblasts was significantly altered compared to infections with wt -rescues, by 4 h after infection these differences were diminished or absent. Consistent with this observation, levels of some critical proteins were reduced in the mutant as compared to rescue infections at the earliest times tested, but were equivalent by 8-12 h pi. Further, both single and multi-step virus replication was equivalent with both mutants and rescues. Thus, altering the immediate early kinetics of ICP27 leads to a sub-optimal quantitative lag-phase in gene expression but without consequence to replication fitness in vitro . Infections in vivo also revealed the ability of mutant and rescue virus to invade the CNS of mice following footpad injections was equivalent. The nature of the role of immediate-early ICP27 expression is discussed in light of these observations.

Large-scale UK audit of blood transfusion requirements and anaemia in patients receiving cytotoxic chemotherapy.

Cancer patients receiving cytotoxic chemotherapy often become anaemic and may require blood transfusions. A large-scale audit of patients with a variety of solid tumours receiving chemotherapy at 28 specialist centres throughout the UK was undertaken to quantify the problem. Data were available from 2719 patients receiving 3206 courses of cytotoxic chemotherapy for tumours of the breast (878), ovary (856), lung (772) or testis (213). Their mean age was 55 years (range 16-87). Overall, 33% of patients required at least one blood transfusion but the proportion varied from 19% for breast cancer to 43% for lung. Sixteen per cent of patients required more than one transfusion (7% for breast, 22% in lung). The mean proportion of patients with Hb < 11 g dl(-10 rose over the course of chemotherapy from 17% before the first cycle, to 38% by the sixth, despite transfusion in 33% of patients. Of the patients receiving transfusions, 25% required an inpatient admission and overnight stay. The most common symptoms reported at the time of transfusion were lethargy, tiredness and breathlessness. Further research is needed to evaluate the role of blood transfusions in patients receiving cytotoxic chemotherapy.

Haematological safety of antipsychotic drugs.

Many clinicians have become concerned about the safety of new antipsychotics particularly in view of the association of agranulocytosis with clozapine and of aplastic anaemia with remoxipride. The Committee on Safety of Medicines and Medicines Control Agency 'yellow card' post-marketing surveillance data were analysed for reports of haemopoietic disorders with the 16 antipsychotics in common use. Corrections for relative risk were made in three separate ways: (i) control for degree of use, using Northern Ireland prescribing data for 1995; (ii) percentage of total reports from 1963 to 1996; and (iii) examination of the first 5 years' post-marketing data only. After clozapine and remoxipride the highest risks of haemopoietic reactions appeared to be associated with the aliphatic phenothiazine derivatives thioridazine and chlorpromazine. There is therefore no evidence of any increased risk with high-potency drugs such as haloperidol or pimozide or with the newer drugs such as sulpiride or risperidone. Continued vigilance, however, is necessary as more new atypicals become available and begin to be widely prescribed.

Reliability of symptom assessment in dyspepsia.

OBJECTIVE: To examine the variation between doctors in their clinical assessment of dyspeptic symptoms. DESIGN: Simulated presentation of three dyspeptic symptom complexes to a total of 27 general practitioners, who each interviewed the 'patient' in accord with their own clinical practice A structured record form was used to record details of the history elicited. SETTING: Simulation of a primary care consultation. RESULTS: Although overall agreement in symptom assessment was reasonable for each of the three symptom complexes, both the accuracy and consistency of assessment varied considerably for individual symptoms. Inconsistency and inaccuracy in the assessment of epigastric pain were unexpectedly large, demonstrating that neither the nature nor severity of pain were communicated reliably. CONCLUSION: The findings illustrate the feasibility of quantitative appraisal of patient-doctor communication in respect of symptoms and show that there is much variation in the reliability with which different symptoms are communicated. Difficulty in characterizing abdominal pain reliably may contribute to the well recognized inadequacy of a conventional clinical history in identifying the cause of a patient's dyspepsia.

A comparison of two cohort studies evaluating the safety of cisapride: Prescription-Event Monitoring and a large phase IV study.

OBJECTIVE: The results of Prescription-Event Monitoring (PEM) from over 13,000 patients receiving cisapride are compared with safety data from a large-scale clinical study involving nearly 10,000 patients. RESULTS: The clinical study population showed a significantly younger age profile than the PEM population and excluded patients with serious disease; however, both studies showed similar patterns of adverse events. The most common adverse events reported in association with cisapride in both studies were diarrhoea, headache, abdominal pain, constipation and nausea. Some of these may be attributed to the underlying condition rather than the action of the drug. Prompting patients about adverse events during a clinical trial assessment appeared to increase the reporting of some conditions: for example, diarrhoea was reported more frequently in the clinical trial than in the PEM study. CONCLUSION: Both studies showed cisapride to be generally safe and well tolerated.

How to do it. Get patients' consent to enter clinical trials.

Gaining patients' consent to enter clinical trials is essential, but not easy. Giving careful thought to the design of the study itself, information which patients receive, and the use of a signed consent form may all help. To be properly informed, patients need to know something about their condition, the proposed study, and alternative options. The type and amount of information will vary and investigators need to judge the level appropriate for each person. Patients should understand that taking part in a clinical trial is voluntary and that their decision will not affect the quality of care they receive. The process of obtaining consent requires time and good communication. Working with young, elderly, or mentally impaired patients, or those particularly vulnerable to coercion, requires special sensitivity to the potential dangers.