title: [Quality assurance in clinical trials. Problems related to patient information].
abstract: In connection with a phase-III study of cholesterol lowering agents, a questionnaire survey was carried out on information to patients' during clinical trials. The survey included 124 patients and nine team members with different professional backgrounds. The results show that, in spite of the fact that the patients had received information in accordance with the guidelines, only 47% of them had perceived that conventional treatment would be offered to those who dropped out of the study. A test of the extent of the patients' understanding about the drugs they were taking showed that only 39% knew how the drug acted and the reasons for the chosen dosing schedule. 23% of the patients would like to have received more information, but 9% of these had problems in formulating questions to the health personnel. Anxiety was a problem for 16% of patients, especially in the early phase of the clinical study. Only half of the team-members were aware of this. 45% of the patients felt that they would disappoint the team if they expressed a wish to drop out of the study. Most of the team-members would have tried to motivate the patients to continue to participate in the trial. Based on the results of the survey, we suggest some main elements of standard procedures for providing information to patients in connection with clinical trials.
authors.affiliation: Rikshospitalet apotek, Oslo.
authors.forename: A G
authors.initials: AG
authors.lastname: Pettersen
authors.forename: G
authors.initials: G
authors.lastname: Eide
authors.forename: A
authors.initials: A
authors.lastname: Skjerdal
authors.forename: I
authors.initials: I
authors.lastname: Wold
authors.forename: L
authors.initials: L
authors.lastname: Ose
mesh_terms: D000328:Adult; D002792:Cholestyramine Resin / Q000008:administration & dosage; D002986:Clinical Trials as Topic / Q000592:standards*; D005229:Fatty Acids, Monounsaturated / Q000008:administration & dosage; D005260:Female; D000077340:Fluvastatin; D006381:Helsinki Declaration; D006801:Humans; D007211:Indoles / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009664:Norway; D010352:Patient Dropouts / Q000523:psychology; D010353:Patient Education as Topic / Q000592:standards*; D011785:Quality Assurance, Health Care; D011795:Surveys and Questionnaires
chemical_list: D005229:Fatty Acids, Monounsaturated; D007211:Indoles; D002792:Cholestyramine Resin; D000077340:Fluvastatin
vernacular_title: Kvalitetssikring ved kliniske utprøvninger. Problemstillinger relatert til pasientinformasjon.