Table 3.

Guidance for researchers on how to use Patient-Centered Outcomes Research Institute’s (PCORI) methodology standards for qualitative and mixed methods research in application preparation

	Application preparation*
Background	Describe the impact of the condition or phenomenon of interest on the health of individuals and populations. Identify and describe evidence gaps that support the need for a qualitative component (QM-1, A) or mixed methods approach of the study (MM-1, A). State the overall goal that addresses the overarching research problem and proposed research question(s). Ensure that the goal informs the research question(s) and specific aims, leading naturally to a qualitative or mixed methods approach.
Research questions and specific aims	State the question(s) the research is designed to address. Describe the specific aims of the study.
Significance	Identify rationale for using qualitative or mixed methods data to address the research question and describe how the study findings will enhance the scientific knowledge.
Study design or approach	Describe the research strategy or methodological approach, including a clear conceptual framework, theory, or model that anchors the background and significance and informs the design. Identify the qualitative approach (eg, ethnography, grounded theory) that will be used, including the purpose, why it is an appropriate approach to answer the research question(s), and how it will be operationalized (QM-1, B). For mixed methods studies describe whether the quantitative and qualitative methods will be sequential, concurrent, or a mixture of both, over time (MM-1, B). Qualitative sampling: Describe and provide the rationale for the sampling strategy, including how the strategy flows logically from the qualitative approach and how it fits the research question(s) (QM-2, A). Explain the anticipated sample size and state the criteria for deciding when no further sampling is necessary (eg, thematic saturation) (QM-2, B). Describe how the methods will ensure that the data capture the depth of experiences of the participants or phenomenon of interest (QM-2, C). Mixed methods sampling: Provide a clear description of the relationship between the sampling techniques and the generation of different types of data (eg, numeric or closed ended v narrative or open ended) (MM-1, A). Describe the sampling strategies and outline the temporality with which they will take place as they relate to selected qualitative and quantitative methodologies, including a justification of the emergence of other samples that may arise during the study, as applicable (MM-2, B). Qualitative studies: Describe the types of data to be collected, strategies for data collection (eg, focus groups, observations, interviews, documents, audio or video recordings), and when the data will be collected (QM-1, C). Mixed methods studies: Describe how the mixed methods design will integrate qualitative and quantitative approaches at one or more stages of the research process and achieve the intent of the design (eg, by aligning the aims to data collection instruments, procedures and analyses of data, and interpretation of the findings) (MM-1, C). Describe how confidentiality will be maintained through data collection, management, analysis, and reporting (QM-1, D). Trustworthiness focuses on consistency and whether the results would be the same if replicated by others. To determine trustworthiness, describe a detailed audit trail, while maintaining fairness, balance, and neutrality. State how documentation regarding all phases of the analysis will be captured. Multiple data collection methods (eg, interviews, focus groups, observations) and/or experts with diverse backgrounds can be used to increase trustworthiness, in addition to an inter-coder reliability process (QM-4, A). To enhance credibility, discuss three distinct elements: rigorous techniques and methods, the role of the qualitative researcher, and the value of participants’ perspectives and experiences. Credibility must be explained and demonstrated in the analysis in at least one of the following three ways: audit trail, reflexivity, negative case analysis, triangulation, and/or member checking (QM-4, B).
Analytic plan	Describe specific plans for data analysis that correspond to major aims. State who will be involved in the data analysis and interpretation and describe how their qualifications, training, and expertise equip them to understand and address the complexities and challenges unique to qualitative methods (QM-3, A). Describe data analysis procedures and their link to the study’s research questions (QM-3, B). This includes data preparation procedures including recording and transcription of data. Coding and theme development strategies should be described. Describe the process by which inferences, and themes will be identified and developed as well as how this process is congruent with the chosen qualitative approach and its methodology (QM-3, C). Describe how conclusions will be derived and how they relate to interpretations and content of the original data (QM-3, D). For mixed methods studies: Describe the analytic approaches to integration and demonstrate how the analysis plan is congruent with the study design and aims, and that it has been developed based on the methodological approach (MM-3, A). Identify the order of study components and the points of integration. State who will conduct the integration; describe how their qualifications, training, and expertise equip them to understand and address the complexities and challenges unique to mixed methods analysis; and state how integrated analyses will proceed in terms of the qualitative and quantitative components (MM-3, B). Describe the approach used to interpret integrated data and how conclusions are supported by the context of original qualitative and quantitative findings. Address divergent findings from both qualitative and quantitative components, as well as method specific biases across the methods (MM-3, C). State the computer software program used to assist with analysis (QM-1, E).
Patient and stakeholder engagement	Describe the plan to engage patients and stakeholders meaningfully in the various phases of the proposed research, identify the patient and other stakeholder partners (individuals or organizations) who will be involved, provide the rationale for their inclusion, and outline the scope of their involvement over the course of the project. Refer to the engagement resources page on the PCORI website (www.pcori.org).

^*Based on PCORI research plan template (https://www.pcori.org/funding-opportunities/announcement/broad-pcori-funding-announcements-cycle-1-2020. PCORI methodology standards can be found at: https://www.pcori.org/research-results/about-our-research/research-methodology/pcori-methodology-standards. QM-1=qualitative approach to research inquiry, design, and conduct; QM-2=select and justify appropriate qualitative methods sampling strategy; QM-3=link the qualitative data analysis, interpretation, and conclusions to the study question; QM-4=establish trustworthiness and credibility of qualitative research; MM-1=specify how mixed methods are integrated across design, data sources, and data/or collection phases; MM-2=select and justify appropriate mixed methods sampling strategy; MM-3=integrate data analysis, data interpretation, and conclusions.