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.

Comparing the efficacy of cisapride and ranitidine in oesophagitis: a double-blind, parallel group study in general practice.

Patients with endoscopically confirmed oesophagitis (n = 49) were treated for 8 weeks with either cisapride (10 mg four times a day) or ranitidine (150 mg twice a day) in a double-blind study in general practice. Mean overall symptom scores fell from 10.8 to 4.5 in the cisapride group and from 9.9 to 4.4 in the ranitidine group over the course of the study. The proportion of patients reporting improvements in individual symptoms in the two treatment groups (cisapride and ranitidine respectively) were: heartburn, 66% and 55%; acid regurgitation, 53% and 47%; epigastric pain, 60% and 52%; satiety, 57% and 47%; bloating, 69% and 71%; belching, 65% and 72%; nausea, 62% and 85%; vomiting, 77% and 66%; poor appetite, 50% and 75%. Improvement in the endoscopic grade of oesophagitis was observed in 66% of patients receiving cisapride and 63% of those receiving ranitidine. It was concluded that cisapride is as effective as ranitidine in relieving the symptoms of oesophagitis and in healing oesophageal erosions.

Treatment of vaginal candidosis--a UK patient survey 1989.

Female patients attending their general practitioner for any reason were asked to complete a questionnaire while waiting for their appointment, and return it to the receptionist before departing. The questionnaire included questions about the sex of the doctor with whom they were registered and whether they had any preference for the sex of doctor if attending with either a gynaecological or nongynaecological complaint. They were asked whether they were examined when attending with suspected vaginal infection, and whether they expected to be examined. Methods of contraception were established and a comparison was possible between the group of patients previously suffering candidosis and those who had never suffered from the complaint. Candidosis patients were asked about treatments received for vulvovaginal candidosis and their preferences for treatment type and length of course. The group of non-sufferers were also asked for their choices if they were ever to suffer from an attack of vulvovaginal candidosis in the future. From 1,167 questionnaires returned for analysis, it was found that 519 patients (44%) had previously suffered from vulvovaginal candidosis. The results show that the majority of candidosis patients would prefer oral therapy for one day, while noncandidosis patients showed a preference for a seven-day course of oral therapy. To select treatments that are acceptable to patients will surely improve compliance, increase chances of cure and hence promote patient satisfaction.

An open clinical trial with 2% miconazole plus 1% hydrocortisone ointment in the treatment of eczematous lesions.

An open, multi-centre study was carried out to assess the efficacy and acceptability of an ointment formulation of 2% miconazole and 1% hydrocortisone ('Daktacort') in 73 patients with eczematous lesions, with or without bacterial superinfection. Patients were instructed to apply the ointment to the lesions morning and evening for 14 days; those with residual lesions were asked to continue treatment for a further 14 days. Assessments of the severity of the patients' symptoms were made by investigators before and after 7 and 14 days of treatment, and a global evaluation of response was made at the end of the treatment period. Patients kept a daily diary for 14 days in which they recorded the severity of their symptoms, acceptability of the ointment and details of any problems associated with treatment. Investigator rating of pruritus, weeping/bleeding, scaling, crusting, erythema, excoriation and burning/pain showed a significant improvement in these symptoms after 7 days and global assessment showed 85% of patients had responded after 14 days of treatment. Patient assessment using a diary card confirmed this improvement, and 96% found the ointment to be an acceptable form of treatment.