Clinical practice guidelines in India: Quality appraisal and the use of evidence in their development.

Background: Guideline development in India has come under increased scrutiny with a growing interest in the use of evidence for guideline development.

Methods: Guidelines on the four leading causes of disability adjusted life years in India (ischemic heart disease, lower respiratory infections, chronic obstructive pulmonary diseases, tuberculosis), published on or after 2010 was searched in electronic databases and by other methods and their quality appraised by using the AGREE-II appraisal tool. In-depth, semistructured interviews were conducted with 15 individuals involved with the development of the included guidelines and the transcripts were analyzed using the framework approach.

Results: We included eleven guidelines. The median AGREE II domain scores was highest for "scope and purpose" (81%) and "clarity of presentation" (76%), and lowest for "rigor of development" (31%) and "editorial independence" (33%). Four main themes emerged from the interviews: (1) Guideline development in India was undergoing transition toward adoption of systematic, transparent and evidence-based approaches but several barriers in the form of attitudes toward use of evidence, lack of methodological capacity, inadequate governance structure and funding exist; (2) guideline development was an academic activity restricted to elite institutions and this affects panel composition, the consultative process and implementation of guidelines; (3) mixed views on patient involvement in guideline development; and (4) Taboo & Poor understanding of issues surrounding conflict of interests.

Conclusion: A multitude of efforts is needed by issuing agencies and the government to ensure development of guidelines in transparent, evidence-based and a systematic manner with high quality in India.