Development of a symptoms-based thyroid risk questionnaire to screen for hypothyroidism in India

Abstract

Context: In India, many cases of hypothyroidism go undetected due to lack of timely screening. Aims: The aim of the study is to develop a symptom-based thyroid risk index (STRI) questionnaire. Subjects and Methods: Questionnaire development involved the following steps: (1) hypothyroidism symptom selection and questionnaire construction based on the literature survey, (2) expert (2 endocrinologists and 2 consultant physicians) review, (3) face validation (Phase 1, cross-sectional survey followed by review by a psychometrician, an endocrinologist, and a layperson), and (4) pilot survey (Phase 2). The face validation was conducted in subjects from general population naïve to their thyroid status (Arm 1 [at 2 nonclinical settings], n = 16) and in subjects with hypothyroidism who were treatment-naïve (Arm 2 [at 2 clinical centers], n = 19). Results were summarized descriptively. Results: Hypothyroid symptoms were incorporated into the questionnaire in the form of 18 questions under four sections and were assigned a score from 1 to 4 based on the strength of literature evidence. The questionnaire underwent face validation followed by incorporation of expert review and recommendations. In Arm 1, 12 subjects (75%) had thyroid-stimulating hormone levels >4.5 mIU/L indicating hypothyroidism. The total mean (standard deviation) STRI score was 25.4 (10.7) in the Arm 1 (29.8 [8.2] in the 12 hypothyroid-positive subjects) and was 18.6 (10.8) in the Arm 2. Conclusions: The STRI questionnaire was successfully face validated for its applicability in clinical and nonclinical settings. The questionnaire, finalized after expert committee review and recommendations, will be validated for its sensitivity and specificity to detect symptoms of hypothyroidism in a pan-India pilot study.