Study Protocol: Validation and Adaptation of community-worker-administered stroke symptom questionnaire in a periurban Pakistani community to determine disease burden.

BACKGROUND Stroke is the second leading cause of mortality and the leading cause of disability in the world today. The disease burden is on the rise in developing nations, but there is scarcity of data from these regions to inform policy decisions. Stroke burden can be determined by clinical diagnosis alone in the public health context and is a far more feasible way to assess disease status in low- to middle-income countries like Pakistan. We aim to translate and adapt a validated stroke symptom questionnaire, train community health workers in its administration, and verify it against assessment by two trained neurologists. METHODS/DESIGN This is a prospective study, which we aim to carry out in Ibrahim Hyderi, a periurban slum of Karachi. We translated into Urdu the questionnaire for verifying stroke free status (QVSFS), which is an internationally validated tool to assess the same. Two community health workers (CHW) will be identified and will receive training by neurologists, which will include teaching regarding stroke pathophysiology, symptomatology, and detection. They will be familiarized with the QVSFS, and their questionnaire administration will be assessed through roleplay. We intend to recruit 322 subjects from the same community and the CHWs will gather data on them. The same subjects will later be assessed by two trained neurologists, and the findings collaborated to validate those obtained by the CHWs. Sensitivity, specificity, positive and negative predictive values, and Cohen's kappa will be determined for the CHW-administered questionnaire tested against assessment by two neurologists together and separately for the two CHWs. Data analysis will be done using SPSS version 19.0. DISCUSSION The results of this study will determine if and how well CHW-administered questionnaires are at assessing stroke status in a community. This will facilitate use of the same as a practical alternative for stroke surveillance in the country. TRIAL REGISTRATION NCT02073955.