Development and validation of a questionnaire to evaluate association of tobacco abuse with oral submucous fibrosis.

OBJECTIVE: Development of a reliable questionnaire to quantify habit of substance abuse with development of oral submucous fibrosis. MATERIALS AND METHODS: The questionnaire, substance abuse and precancer evaluation (SAPE) tool, was designed to assess the association of the habit of substance abuse with development of oral submucous fibrosis, a precancerous condition and various physical, social, psychological factors. Health professionals confirmed the content validity. Face validity was established by a participant focus group. The questionnaire was applied to 1100 participants with or without habit of substance abuse. RESULTS: A total of 52 validated items were applied to the participants. Principal component analysis yielded 8 components having eigenvalues >/=2.0. Reliability was obtained by Cronbach's alpha. The validity was measured by computing product-moment correlation coefficient between the diagnosis and the scores on the selected components. CONCLUSIONS: Preliminary reliability and validity of the SAPE tool has been demonstrated although more extensive testing is suggested.