key: cord-0876474-1t2c4wvr authors: Bandhu Kalanidhi, Kamal; Ranjan, Piyush; Sarkar, Siddharth; Kaur, Tanveer; Dutt Upadhyay, Ashish; Singh, Amandeep; Sahu, Anamika; Khan, Munnoo; Vijay Prasad, Barre; Baitha, Upendra; Kumar, Arvind title: Development and validation of a questionnaire to assess socio-behavioural impact of COVID-19 on the general population() date: 2021-02-18 journal: Diabetes Metab Syndr DOI: 10.1016/j.dsx.2021.02.019 sha: 3033d18a593916dae2f8cfdd4eaa6b4254893e0e doc_id: 876474 cord_uid: 1t2c4wvr BACKGROUND AND AIM: The aim of the study is to develop a valid and reliable tool to assess socio-behavioural changes. METHODS: This mixed method study has two phases. Phase I for questionnaire development (literature review, focus group discussion, expert evaluation and pilot testing). Phase II for establishing construct validity via factor analysis and internal consistency via Cronbach's ɑ by administering the questionnaire on 179 participants. RESULTS: A questionnaire comprising 33 questions and five domains was developed having Cronbach's α of 0·82. DISCUSSION: The developed questionnaire is a concise, easy to administer and valid tool to assess socio-behavioural changes. Background and aim: The aim of the study is to develop a valid and reliable tool to assess socio-behavioral changes. Methods: This mixed method study has two phases. Phase I for questionnaire development (literature review, focus group discussion, expert evaluation and pilot testing). Phase II for establishing construct validity via factor analysis and internal consistency via Cronbach's ɑ by administering the questionnaire on 179 participants. Cronbach's α of 0·82. The developed questionnaire is a concise, easy to administer and valid tool to assess socio-behavioral changes. There is a pressing need to study the impact of these socio-behavioural changes, whether positive or negative, at an individual as well as at a community level. Having a scale or an instrument is likely to be helpful to assess these changes systematically. There is a paucity of comprehensive tools to assess the diversity and depth of the socio behavioural changes among the general population in response to the COVID pandemic. A couple of scales available are primarily from the developed countries and are not validated on Indian population (7, 8) . This paper aims to develop a validated tool to assess the sociobehavioural changes due to COVID-19. The development and validation of the questionnaire was done using mixed methods study design. A standardised methodology included literature review, focus group discussion, expert review, pre-testing (Phase 1) and validation (Phase 2) (9). For the purpose of item-generation, electronic literature review was carried out using Google scholar and PubMed search engines using the key string (Coronavirus OR Pandemic OR COVID-19) AND (Scale OR Questionnaire OR Tool) AND (Social*) AND (Behavioural*).The procedure for the development of the questionnaire is depicted in Table 1 . In this phase, a questionnaire was prepared and the data was collected from 179 participants of different demographic strata such as age, sex, socio-economic status, to ensure the principle of maximum diversity. The questionnaire was designed on Google forms and data was collected from 9th -16th December,2020. The face and the content validity of the developed questionnaire was established in FGDs, expert evaluation and pre-testing. For construct validity, the exploratory factor analysis with varimax rotation was carried out to test the domain structure (10). Cronbach's α was calculated to measure the internal consistency and Kaiser-Mayer-Olkin (KMO) measure was used to assess adequacy of the sample. Eigenvalue threshold of 1 was used to determine the number of factors in the factor (8), using IBM SPSS Statistics 24 software. Final questionnaire comprises 33 items. The questionnaire has a good internal consistency with Cronbach's α of 0·82. Construct validity of the questionnaire was established using principal factor analysis with varimax rotation. The correlation matrix was used to assess the degree of correlation. Kaiser-Meyer-Olkin value (0.78) with Bartlett test of sphericity (p <0.01) established adequacy of the sample. Kaiser's criterion was used to enter thirty-two items into the analysis. A total of nine domains were identified after the factor analysis. The questionnaire and the scoring scheme are enclosed in Appendix A and B, respectively. This questionnaire is free to use. The demographic details of 179 participants are presented in Table 2 . The responses of the participants in the respective domains have been given in the Supplementary table 1. As the world is going through the process of "Covidisation", significant changes in medical, economic, social and behavioural health are expected (11) . "The Bandwagon Effect" and "The Health Belief Model" play an important role in determining the compliance to these changes even after the flattening of the curve (12, 13) . Researchers have tried to study these changes by developing questionnaires to assess changes in lifestyle related behaviours, preventive practices and psycho-social functioning (14) (15) (16) (17) (18) . On the other hand, tools to assess social and behavioural changes have also been developed in the west but, their reliability and validity stands questionable and cannot be applied on the Indian population due to socio-cultural differences. Therefore, this tool can be used on the Indian as well as the South-East Asian countries. The limitations of the study include inability to determine the concurrent/ predictive validity, and limiting the sample primarily to those who could be accessed through online invites. Despite the limitations, it is the first tool to be developed to assess the socio-behavioural changes due to COVID among the general population. The tool has good internal consistency, content validity, face validity and construct validity. The questionnaire is short and can be self-administered in approximately 10 minutes. This tool will help in assessing the changes in the social and the behavioural domain and will help health professionals and educators to assess the outcomes of strategies and interventions to improve the adherence to behavioural measures and reduce the psychological impact due to these changes. J o u r n a l P r e -p r o o f COVID-19 and mental health: A review of the existing literature. 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