1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [prajakta.sahasrabudhe2@gmail.com].
   


6. For how long will this data be available start date provided 10-11-2027 and end date provided 10-02-2031?
   Response - Beginning 9 months and ending 36 months following article publication.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

Although there is a wide choice of generic and disease specific patient reported outcome measures (PROM) available for patients diagnosed with cardiac pathologies, most of those are specific to diagnoses than for impairments perceived by the patients and fail to assess multiple aspects of impairments, activities and participations and contextual factors and domains of health-related quality of life comprehensively. Concept of HRQOL varies with respect to attitude, cultural practices and idea of societal participation; hence PROMs used to assess HRQOL might not be generalizable outside the boundaries of these culture specific factors.  None of the available tools for cardiac diseases were developed considering Indian cultural practices and beliefs at its core. All these factors necessitate need of a new and more comprehensive PROM for use in Indian adult patients who have either conservatively or surgically treated cardiac disease.  In the present proposal, we present the idea of development and validation of a patient reported tool to assess HRQOL in these patients.

In the development phase of the study, patients having known cardiac dysfunctions and stable disease will be assessed qualitatively and quantitatively to understand their lifestyle, severity and impact of disease related impairments, limitations in activities and participation and factors affecting these. On the basis of above assessment, a closed ended questionnaire will be generated in English, Hindi and Marathi with multiple choice options based on Likert scale by choosing relevant clinical items. In the validation phase, the questionnaire developed will be validated for its outline and contents by experts in the field. The final version of the questionnaire will be presented to a cohort of patients having diagnosed cardiac dysfunctions and construct validity, reliability and responsiveness of the tool will be established.