Randomized clinical trial of total vs. subtotal hysterectomy: validity of the trial questionnaire

Autor: Helga Gimbel, Ann Tabor, Bent Ottesen, Vibeke Zobbe
Rok vydání: 2002
Předmět:
Zdroj: Acta Obstetricia et Gynecologica Scandinavica. 81:968-974
ISSN: 0001-6349
DOI: 10.1034/j.1600-0412.2002.811012.x
Popis: Acta Obstet Gynecol Scand 2002; 81: 968-974. © Acta Obstet Gynecol Scand 2002 Background. To ensure the internal validity of a trial it is recommended to undertake a validation study of the method measuring the outcome. Aims. To validate a self-administered, postal questionnaire ( http://www.gyncph.suite.dk/praes/gimbel/gihtm) used for measuring the outcomes of a randomized clinical trial of total vs. subtotal abdominal hysterectomy. Methods. A study of the content validity (10 patients) and a combined qualitative and quantitative validation study (20 patients) were performed. Results. The median kappa of the 74 questions was 0.71 (range 0.22-1.00) and the median overall agreement was 0.76 (range 0.25-1.00). Five questions (7%) had kappa values below 0.40, 11 questions (15%) between 0.40 and 0.60, and 58 questions (78%) above 0.61. Three questions with a kappa value below 0.40 had an overall agreement of 0.75 or more. Significant logical inconsistencies were found in five questions, where the operation me...
Databáze: OpenAIRE