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Development and Validation of Questionnaire Assessing the Perception of Hospital Patient Safety Practices in Public Health Facilities of India.

BACKGROUND
In ''To Err is Human'' released by the Institute of Medicine Committee on Quality of Health Care, it was emphasized that it is important to establish a safety culture in the hospitals and ensure that the patients are not inadvertently harmed by the errors. Hence, we developed and validated a questionnaire for assessing the perception of patient safety practices across the secondary and tertiary care facilities in India.


METHODS
The scale was developed based on literature review and expert opinion. It consisted of 10 questions and response to these items were based on a 5-point Likert scale ranging from "strongly agree" to "strongly disagree". All the analysis was performed using STATA version 14.2 software. Exploratory factor analysis (EFA) was run using principal components analysis with oblique Promax rotation, and confirmatory factor analysis (CFA) using structural equation modelling with maximum likelihood estimation.


RESULTS
The entire dataset was split into testing set to run EFA (with 692 participants) and validation set to run CFA (with 645 participants). In EFA, two factors were retained as they had eigenvalue more than one (4.76, 1.09) and the scree plot also showed that the slope flattens off after two factors. Factor loadings were generated using oblique promax rotation. Factor 1 consisted of seven items (Item 1, Item 2, Item 3, Item 4, Item 5, Item 6, Item 7 - questions related to patient-doctor communication, hospital environment and procedures) accounting for 47.6% of variance, and Factor 2 had three items (Item 8, Item 9, Item 10 - infection prevention and control practices in hospital) explaining 10.9% of the variance. Thus, together the two factors explained 58.5% of the variance. CFA revealed good confirmatory fit indices of 0.85, standardized root mean square residual of 0.07 and acceptable Tucker-Lewis Index of 0.80. The reliability coefficient was 0.88 indicating very good internal consistency.


CONCLUSION
This study develops and validates a scale that can be used universally for assessing the patients' perception on hospital safety practices across secondary and tertiary care facilities in India.