Published: 2022-01-28

Tool development and validation of the oral cancer patient and diagnostic interval measure

Phinse Mappalakayil Philip, Srinivasan Kannan


Background: The poor survival rates observed in oral cancer can be improved if diagnosed early. A greater understanding of the patient and diagnostic interval in the diagnostic journey of oral cancer is vital for facilitating early diagnosis. The non-availability of a validated tool for measuring these intervals impedes early diagnosis research.  The present study aimed to develop a tool to measure the patient and diagnostic intervals for early oral cancer diagnosis researchers.

Methods: To include appropriate questions to get the exact days, the researcher has first searched for published articles on the subject. This was followed by consultations with health care providers. The list of variables finalized through these iteration processes was circulated among the experts for establishing content validity. The face validity of the conceptually equivalent local language version of the tool was also assessed. The tool was developed as an interview schedule.

Results: The final tool had 16 symptom response categories and 14 other questions. Items with a content validity index of 0.8 or above were only included. The validated tool was further used in a cross-sectional study on patient interval. The most common initial symptoms recognized by the participants were non-healing ulcer with pain (n=97), tooth mobility (n=26), and non-healing ulcer without pain (n=25).

Conclusions: A tool was developed and validated for collecting various time points for measuring various time points in the diagnostic journey of oral cancer. To our knowledge, this is the first tool for measuring patient intervals and diagnostic interval in oral cancer.


Diagnostic interval, Oral cancer, Patient interval, Tool development

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