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

Table 1.

Terms and definitions used in the development of the Patient-Centered Outcomes Research Institute’s (PCORI) qualitative and mixed methods research methodology standards

Term Definition Source
Patient centered outcomes research (PCOR) Research guided by those who will use the information and centered around outcomes important to patients; PCOR studies aim to help patients and caregivers make better informed decisions about the healthcare choices they face PCORI4
Comparative effectiveness research Generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. Comparative effectiveness research aims to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve healthcare at both the individual and population levels Institute of Medicine5
Qualitative methods research An approach to inquiry and evaluation that gathers non-numerical data, such as focus groups and interviews, which aims to characterize people’s beliefs, attitudes, experience, behaviors, and interactions to achieve a depth and richness of information about a research area of study Crabtree and Miller6
Trustworthiness Extent to which the investigative process establishes the study’s findings are credible, transferable, and confirmable, thereby ensuring reliability of its findings and enabling the replication of the processes and results Creswell and Miller7
Credibility Establishing the integrity of the research process to ensure a high level of confidence in the accuracy and validity of the findings Crabtree and Miller6; Creswell and Miller7
Reflexivity Process of systematically attending to and recording the process of knowledge construction that addresses the influence or effect of the researcher’s own beliefs and attitudes at every step of the research process Malterud8
Negative or deviant case analysis Process of exploring cases that run counter to emerging theories of conclusions, in order to include cases that might not fit an emerging perspective and thereby revising, broadening, or confirming emerging patterns from data analysis Patton9
Member checking Validation technique and process of proving or disproving a finding through exploring the credibility of results by returning the data to the participants Creswell and Poth10
Triangulation Use of different methods (eg, interviews and focus groups) or experts with different backgrounds (eg, anthropology and nursing) in one study, which enables a richer account of the narrative Creswell and Poth10; Patton11
Audit trail Providing detail about data collection and analysis so that readers can fully understand the process, such as a clear definition of methods, meticulous documentation of data collection and data analysis, details on coding strategies, and the codebook development process (eg, when conducting an audit trail for the coding process, researchers document the creation of codes, as well as the collapsing or splitting of codes so that a full inventory of the coding process can be produced) Creswell and Poth10
Mixed methods research Inquiry and evaluation that is driven by the research question and a priori deliberately integrates quantitative and qualitative methods from inception to analysis to provide a broader perspective than with a single method approach alone Creswell et al12
Integration Process of incorporating or linking qualitative and quantitative components at every level in the research process; from design to methods, interpretation, and reporting, each component of qualitative and quantitative efforts informs and guides the other Fetters et al3