Introduction of new vaccines for immunization in pregnancy - Programmatic, regulatory, safety and ethical considerations.

Immunizing pregnant women is a promising strategy to reduce infectious disease-related morbidity and mortality in pregnant women and their infants. Important pre-requisites for the successful introduction of new vaccines for immunization in pregnancy include political commitment and adequate financial resources: trained, committed and sufficient numbers of healthcare workers to deliver the vaccines; close integration of immunization programs with antenatal care and Maternal and Child Health services; adequate access to antenatal care by pregnant women in the country (especially in low and middle-income countries (LMIC)); and a high proportion of births occurring in health facilities (to ensure maternal and neonatal follow-up can be done). The framework needed to advance a vaccine program from product licensure to successful country-level implementation includes establishing and organizing evidence for anticipated vaccine program impact, developing supportive policies, and translating policies into local action. International and national coordination efforts, proactive planning from conception to implementation of the programs (including country-level policy making, planning, and implementation, regulatory guidance, pharmacovigilance) and country-specific and cultural factors must be taken into account during the vaccines introduction.

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.

Use of evidence for clinical practice guideline development.

Clinical practice guidelines provide a framework against which quality of care is measured. Recommendations contained within guidelines are used for decision-making not only within the clinical domain but also other related issues within the health systems. As such the use of research evidence for formulating recommendations contained in a guideline is a global standard to ensure guideline quality. The paper briefly reviews how the need for and use of evidence in guideline development shaped up historically and then provides an overview of the four typologies of guideline development mechanisms at the country level.