COREQ (Consolidated Criteria for Reporting Qualitative Research)
A 32-item reporting checklist, organized in three domains, for transparent reporting of qualitative studies that collect data through individual interviews or focus groups.
What it is
— COREQ (Consolidated Criteria for Reporting Qualitative Research) is a 32-item reporting checklist published by Tong, Sainsbury, and Craig in 2007 and maintained as an EQUATOR Network reporting guideline. It was developed by reviewing 22 prior qualitative checklists and consolidating their most frequently recommended items into a single instrument for interview- and focus-group-based studies. The 32 items sit in three domains: (1) Research team and reflexivity — interviewer/facilitator identity, credentials, occupation, gender, training, and the relationship with participants (prior contact, interviewer assumptions, reasons for the study); (2) Study design — theoretical/methodological orientation (grounded theory, phenomenology, content analysis, etc.), participant selection and recruitment, sample size, non-participation, setting, presence of non-participants, and a description of the sample; data collection covering the interview guide, pilot testing, repeat interviews, audio/visual recording, field notes, duration, and whether data saturation was discussed; and (3) Analysis and findings — number of coders, coding-tree derivation, software, participant checking (member checking), quotations with participant identifiers, consistency between data and findings, presentation of major and minor themes. COREQ is a reporting tool: it specifies what must be disclosed so a reader can judge a study, not a verdict on whether the study was done well.
When to use
— Reach for COREQ when you are reporting (or peer-reviewing, or registering a protocol for) a qualitative study whose primary data are one-on-one interviews or focus groups. In RWE/HEOR programs this is most often a qualitative arm rather than a standalone paper: concept-elicitation and cognitive-debriefing interviews that establish content validity of a patient-reported outcome (PRO) instrument under the FDA PRO Guidance; the formative qualitative phase of a stated-preference / DCE study; patient, caregiver, clinician, or payer interview substudies embedded in a registry, observational, or mixed-methods program; and exit interviews appended to pragmatic or single-arm studies. Decision rule for choosing COREQ over its siblings: if the data are interviews/focus groups, use COREQ; if the qualitative work spans broader methods (ethnography, document/textual analysis, observation), use SRQR (O'Brien 2014) instead; if you are synthesizing primary qualitative studies, use ENTREQ, not COREQ. COREQ supports — it does not replace — the design-level reporting standard for the quantitative components (STROBE/RECORD-PE for the observational analysis, CONSORT-PRO/SPIRIT-PRO for trial-embedded PROs, CHEERS for the economic model).
What it requires
— The substantive disclosures COREQ enforces are specific to qualitative inquiry and do not overlap with quantitative RWE reporting domains. It demands: reflexivity — who collected the data, their training and standpoint, and their relationship to participants, because the interviewer is the measurement instrument; transparent sampling — how participants were identified, approached, and selected, who declined, and a sample description, so readers can judge transferability rather than statistical representativeness; instrument and procedure transparency — the interview/topic guide, pilot testing, setting, recording method, field notes, and an explicit statement on whether thematic saturation was reached; and analytic auditability — number of coders, how the coding framework was derived, analysis software, whether participants reviewed findings, and verbatim quotations tied to identifiers that evidence each theme. These map onto the catalog's qualitative fitness-for-purpose ideas (credibility, dependability, confirmability, transferability) rather than phenotype validation, time-zero alignment, estimands, or confounding control, which are simply not in scope for an interview study.
When NOT to use — limitations and common misapplications
— (1) It is a reporting checklist, not a risk-of-bias or quality instrument. A study that reports all 32 items is fully described, not rigorous; use JBI's qualitative critical-appraisal checklist (or CASP) to appraise methodological soundness. Conflating COREQ completeness with study quality is the single most common error. (2) Wrong design. Applying COREQ to ethnography, observational fieldwork, document analysis, or grounded-theory work that is not interview/focus- group-based forces a mismatched instrument — use SRQR. (3) Wrong activity. COREQ does not govern qualitative evidence synthesis (use ENTREQ) and has nothing to say about the secondary-data, quantitative analyses in an RWE study — STROBE, RECORD-PE, HARPER, and CHEERS own those. Using COREQ where RECORD-PE/HARPER is required leaves the design-transparency gaps that regulators and HTA reviewers actually scrutinize. (4) Checklist-as- theater. A submitted COREQ grid with page numbers that do not contain the claimed content, or items marked "N/A" without justification, is worse than none. (5) Over-literal scoring. Buus & Perron (2020) replicated COREQ's development and documented inconsistent interpretation of several items; treat COREQ as a structured prompt for transparent narrative, not as a numeric score to be summed or thresholded.
How it maps to this catalog
— COREQ is the reporting layer for the catalog's qualitative and PRO-development concepts. It directly governs reporting for qualitative-interview (its core use case) and the qualitative arm of mixed-methods programs. Its strongest RWE/HEOR anchor is pro-development and pro-validation: concept-elicitation and cognitive-debriefing interviews that establish PRO content validity should be reported against COREQ so reviewers can audit saturation, sampling, and coding. It applies to the qualitative formative phase of a preference-study (the interviews that generate DCE attributes and levels). It is distinct from qualitative-synthesis, which is reported under ENTREQ — a deliberate contrast, not an overlap. For ethnographic designs see qualitative-ethnographic, where SRQR rather than COREQ is the appropriate standard. Applied note for claims/EHR/registry RWE: COREQ does not govern the secondary-data analysis itself — when a database study has no primary qualitative data collection, COREQ does not apply. It becomes relevant only when a qualitative component is bolted onto the program (e.g., clinician interviews to validate an EHR phenotype's clinical face validity, patient interviews to interpret an unexpected registry signal, or payer interviews in an HTA dossier). Report those qualitative substudies under COREQ and keep the quantitative analysis under its own design-appropriate guideline.