Influence of the'directions for use'on positivity rates of the Hemoccult II test.
Objective A concise, detailed, and complete instruction sheet is indispensable for adequate completion by the users of a product This sheet should be enclosed in the envelope which contains Hemoccult II slides.
The authors found that the instructions provided by the French manufacturer were unsatisfactory.
They designed a short and simple notice, adequately detailed to be understandable by all volunteers and to obtain satisfactory stool smears.
Positivity rates of Hemoccult II performed with the manufacturer's notice were compared to those obtained with Hemoccult II performed with the authors'instructions.
Methods This study was made during the third screening campaign carried out by the Office Départemental de Lutte contre le Cancer (ODLC).
This screening programme only concerned women 59 to 69 years of age.
Six thousand three hundred and ninety-two Hemoccult II containing the manufacturer's instructions were received at the laboratory during March, April, May, June and July 1996, and 2633 Hemoccult II containing the ODLC instructions during March, April, May, June and July 1997.
All Hemoccult II were developed and read by one trained technician in the Biochemistry Laboratory (Grenoble University Hospital). the manufacturer's instructions, 157 (2.5%) were found positive, as compared to 36 (1.4%) Hemoccult II out of 2633 which contained the authors'instructions.
This difference is highly significant (P=0.001). (...)
Mots-clés Pascal : Carcinome, Côlon, Rectum, Diagnostic, Sang, Fèces, Examen laboratoire, Instruction, Utilisation, Evaluation performance, Homme, Tumeur maligne, Appareil digestif pathologie, Intestin pathologie, Côlon pathologie, Rectum pathologie, Economie santé, Equipement biomédical
Mots-clés Pascal anglais : Carcinoma, Colon, Rectum, Diagnosis, Blood, Feces, Laboratory investigations, Instruction, Use, Performance evaluation, Human, Malignant tumor, Digestive diseases, Intestinal disease, Colonic disease, Rectal disease, Health economy, Biomedical equipment
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 99-0074097
Code Inist : 002B24O06. Création : 31/05/1999.