Background: Guideline development has changed internationally with greater stress on the use of rigorous, transparent and evidence-based methods, but not much is known about these issues in India.
1. To appraise the quality of Indian guidelines for 4 conditions with the highest disease burden.
2. To understand the guideline development process in India and how evidence is used in it.
Methods: Guidelines for 4 leading causes of disability-adjusted life years in India, published on or after 1 January 2010, were searched in multiple electronic databases, related websites, and by contacting experts and checking reference lists, and were quality appraised using the AGREE-II appraisal tool.
In-depth, semi-structured interviews with 15 people involved in the development of the included guidelines were conducted and analysed using the framework approach
Results: The median AGREE II domain scores for the 11 included guidelines were highest for 'scope and purpose' (81%) and 'clarity of presentation' (76%), and lowest for 'rigour of development' (31%) and ‘editorial independence’ (33%).
Four main themes emerged: (1) guideline development is undergoing a transition towards the adoption of systematic, transparent and evidence-based approaches but several barriers in the form of attitudes towards use of evidence, lack of methodological capacity, inadequate governance structure and funding exist; (2) guideline development is an academic activity restricted to elite institutions and this affects the panel composition, the consultative process and the implementation of guidelines; (3) there are mixed views on patient involvement; and, (4) there are taboos and poor understanding of issues surrounding conflicts of interest.
Conclusions: Progress towards better-quality guidelines in India requires governance, planning and dedicated funding, changes to the medical curriculum and capacity-building efforts. Issuing agencies need to make panels more representative, search and appraise evidence appropriately, and have formal processes for formulation of recommendations and disclosure of conflict of interest.