A structured, eleven-step guide to writing a mixed-methods research protocol in the health sciences
Explore the 11 Steps How to CiteAbout the Framework
This framework guides the writing of a research protocol for a mixed-methods study in the health sciences — that is, the document prepared before data collection begins, for submission to a research committee, an institutional ethics committee, a doctoral committee, or a funding body.
It is not a guideline for reporting a completed mixed-methods study. For that purpose, readers are directed to the GRAMMS criteria and to the relevant EQUATOR-listed reporting guidelines for the component strands.
Because a protocol describes research not yet undertaken, the framework contains no Results component. Steps 8 and 9 accordingly address what the investigator plans to do with the findings, not what those findings were.
Mixed-methods research integrates quantitative precision with qualitative depth, offering a richer understanding of complex health phenomena. Yet clinician-researchers — especially in low- and middle-income settings — receive little formal training in designing or reporting such studies.
Krishna Raj's Framework for Mixed-Methods Protocol addresses this gap by providing eleven logically sequenced, mutually reinforcing steps — each explained through familiar clinical analogies — to make mixed-methods protocol writing accessible to every medical researcher, irrespective of their prior methodology training.
The framework is applicable across mixed-methods design typologies including Explanatory Sequential, Exploratory Sequential, and Convergent Parallel designs, and is particularly suited to community medicine, public health, health systems research, and implementation science.
Medical researchers • Public health professionals • Postgraduate students • Research supervisors • Journal reviewers • Funding bodies evaluating mixed-methods proposals
Every abstract methodological concept is paired with a clinical analogy — a familiar medical procedure or diagnostic reasoning pattern — so the framework feels intuitive to clinicians from day one.
The Framework
Each step represents a distinct, essential component of a mixed-methods research protocol. The steps are sequenced to guide the researcher from philosophical grounding through to complete documentation, mirroring the logical progression of clinical diagnostic reasoning. Because a protocol is written before a study begins, there is no Results step; Steps 8 and 9 set out what the investigator plans to do with the findings.
Select and justify the theoretical lens guiding both quantitative and qualitative strands. Analogous to selecting the diagnostic paradigm before ordering investigations.
Narrate the research problem, establish the gap in existing evidence, and justify why integration of both data types is necessary. Like a detailed clinical history that justifies the workup.
Define Specific, Measurable, Achievable, Relevant, and Time-bound objectives that span both data strands. Equivalent to setting clear treatment targets before initiating therapy.
Formulate a primary integrated research question and sub-questions that link quantitative and qualitative components. Like a clinical question that requires both lab values and patient narratives to answer.
Declare the philosophical stance (pragmatism, transformative, etc.) that underpins the mixed-methods design. Comparable to the clinician's epistemological approach to diagnosis — evidence-based versus narrative-centred.
Systematically map gaps in both quantitative and qualitative literature, demonstrating that integration is the only approach to fill the identified gap. Like a differential diagnosis supported by prior case evidence.
Specify the mixed-methods design type, sampling strategy, data collection instruments, integration point, and joint display plan. The core of the protocol — equivalent to the operating theatre protocol.
State in advance how the two strands will be brought together, how discordance between them will be handled if it arises, and what limitations are anticipated. Like the pre-operative plan that anticipates complications before the incision is made.
State what the study is expected to contribute, to whom the findings will matter, and how they will be disseminated. Like the discharge plan agreed at admission rather than written at discharge.
Document all cited sources in APA 7th edition format with a minimum of 30 sources spanning both methodological and substantive literature. Like the evidence base underpinning a clinical practice guideline.
Include all instruments (quantitative tools, qualitative guides), informed consent forms, ethical clearance, and a Gantt chart. The complete investigator's toolkit — like the surgical tray laid before the procedure.
Validation & Registration
A multi-round Modified Delphi consensus study is being prepared to establish the content validity of the framework, to be conducted in accordance with the CREDES (Conducting and REporting DElphi Studies) reporting standard. Consensus thresholds are pre-specified as an item-level Content Validity Index (I-CVI) of ≥0.78 together with ≥80% agreement. Recruitment of the expert panel has not yet commenced.
The framework is listed on the register maintained by the EQUATOR (Enhancing the QUAlity and Transparency Of health Research) Network, under Qualitative or mixed-methods studies, as “A Reporting Guideline for Mixed-Methods Research Protocols in Health Sciences (2026).”
The EQUATOR Network states that registration of a guideline under development does not imply endorsement. The register exists to signal work in progress and to prevent duplication of effort.
How to Cite
Researchers using, discussing, teaching, or applying this framework should cite it using the following format (APA 7th edition):
This framework is made available under a Creative Commons Attribution (CC BY 4.0) licence. You are free to share and adapt the material for any purpose, provided appropriate credit is given, the licence is indicated, and changes are noted.
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