Krishna Raj's Framework for Mixed-Methods Protocol: A Structured Eleven-Step Guide to Writing a Mixed-Methods Research Protocol in the Health Sciences

BACKGROUND Mixed-methods research integrates quantitative and qualitative enquiry within a single study and is increasingly employed in community medicine, public health, epidemiology, health systems research, and implementation science. Formal training in mixed-methods protocol development is, however, limited in many medical curricula. Protocols consequently often describe two parallel studies rather than one integrated design, leaving the philosophical paradigm implicit, the point of integration unstated, and joint displays absent. PURPOSE Existing reporting standards - STROBE, CONSORT, COREQ, SRQR, and GRAMMS - guide the reporting of research already conducted. None functions as a template for writing a protocol before a study begins. This framework addresses that gap. THE FRAMEWORK Krishna Raj's Framework for Mixed-Methods Protocol comprises eleven sequenced components: (1) Theories; (2) Introduction; (3) SMART Aims; (4) Research Question; (5) Paradigm; (6) Literature Review; (7) Method; (8) Planned Interpretation and Integration; (9) Expected Outcomes and Dissemination; (10) References; (11) Appendix. Each component is paired with a clinical analogy - a familiar diagnostic or procedural reasoning pattern - intended to render abstract methodological constructs intuitive to clinician-researchers encountering mixed-methods design for the first time. The framework applies across the principal mixed-methods design typologies: explanatory sequential, exploratory sequential, and convergent parallel. Because a protocol describes research not yet undertaken, the framework contains no Results component. INTENDED USERS Medical researchers; public health professionals; postgraduate students preparing dissertation protocols; research supervisors; institutional ethics committee members; and reviewers assessing mixed-methods submissions. DEVELOPMENT STATUS This document presents the framework as originally developed. It is listed on the EQUATOR Network register of reporting guidelines under development, under Qualitative or mixed-methods studies. The EQUATOR Network states that registration of a guideline under development does not imply endorsement; no endorsement by the EQUATOR Network, or by any other body, is claimed or implied. A modified Delphi expert consensus study is in preparation to establish the content validity of the framework, to be conducted in accordance with CREDES guidance. Ethical approval has been obtained from the Institutional Ethics Committee, Malabar Medical College Hospital and Research Centre (Ref: MMCH&RC/IEC/2026/Aug/47, dated 21 August 2026). A revised version will be deposited following completion of the study. RIGHTS Registered under the Copyright Act, Government of India, Registration No. LD-20260185261, dated 16 April 2026, held jointly by Dr Krishna Raj J S and Malabar Medical College and Research Centre. Made available under a Creative Commons Attribution 4.0 International licence. Further information: https://www.mixedmethodsprotocol.org