Improving the conduct and reporting of clinical trials.
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Clinical Trials as Topic↗
Biomedical subjects
E Wager
Publications and source records attributed to E Wager.
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.
Adolescent↗
Good publication practice guideline for pharmaceutical companies.
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Clinical Trials as Topic↗
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.
Agranulocytosis↗
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.
Adolescent↗
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.
Abdominal Pain↗
Redefining authorship. Drug industry is increasingly allowing employees to be named as authors.
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Authorship↗
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.
Clinical Trials as Topic↗