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. 2020 Dec 23;371:m4435. doi: 10.1136/bmj.m4435

Table 2.

Patient-Centered Outcomes Research Institute’s (PCORI) methodology standards for qualitative methods and mixed methods

Standards for qualitative methods
QM-1: State the qualitative approach to research inquiry, design, and conduct A. Identify and describe evidence gaps that support the need for a qualitative component(s) of the study
B. 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
C. 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
D. Describe how confidentiality will be maintained through data collection, management, analysis, and reporting
E. State the computer software program used to assist with analysis
QM-2: Select and justify appropriate qualitative methods sampling strategy A. Describe and provide the rationale for the sampling strategy (see RQ-3†, RQ-4†, and PC-2‡), including how the strategy flows logically from the qualitative approach and how it fits the research question(s)
B. Explain the anticipated sample size, detail any variation in sampling that may occur over the course of study, and state the criteria for deciding when no further sampling is necessary (eg, thematic saturation)
C. Describe how the methods will ensure that the data capture the depth of experiences of the participants or phenomenon of interest (see PC-2‡ and PC-3‡)
QM-3: Link the qualitative data analysis, interpretations, and conclusions to the study question A. 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
B. Describe data analysis procedures and their link to the study’s research questions
C. 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
D. Describe how conclusions will be derived and how they relate to interpretations and content of the original data
QM-4: Establish trustworthiness* and credibility of qualitative research A. 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
B. 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 (see RQ-1†, RQ-2†, and IR-7§) and demonstrated in the analysis in at least one of the following three ways: reflexivity, negative case analysis, and/or member checking
Standards for mixed methods research
MM-1: Specify how mixed methods are integrated across design, data sources, and/or data collection phases A. State which mixed methods approach will be used and describe how it will inform the study procedures
B. Describe whether the quantitative and qualitative methods will be sequential, concurrent, or a mixture of both, over time
C. 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-2: Select and justify appropriate mixed methods sampling strategy A. 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; see RQ-3†, RQ-4†, and QM-2¶)
B. Describe the sampling strategies and outline the temporality with which they will take place as they relate to selected qualitative and quantitative methodologies (see IR-1§, IR-2§, PC-2‡, PC-3‡, and QM-1¶), including a justification of the emergence of other samples that may arise during the study, as applicable
MM-3: Integrate data analysis, data interpretation, and conclusions A. 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 (eg, either a priori or emergently; see IR-1§, IR-2§, PC-2‡, PC-3‡, QM-1¶, and QM-3¶)
B. 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
C. 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 (see QM-4¶)
*

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.