CONSORT-PRO

What it is

CONSORT-PRO is the Consolidated Standards of Reporting Trials extension for Patient-Reported Outcomes, published by Calvert and colleagues (JAMA, 2013) as a formal extension to the CONSORT 2010 statement. It is a reporting checklist — not a design protocol, a risk-of-bias tool, or a quality score — that tells authors, reviewers, and regulators what must appear in a trial report whenever a PRO is a primary or important secondary endpoint. It adds five PRO-specific elaborations to the core CONSORT items (and modifies several others): the PRO is identified in the abstract; a PRO hypothesis is stated with relevant domains; the instrument's validity, reliability, and (where relevant) responsiveness are documented with citations; statistical approaches for dealing with missing PRO data are described; and PRO-specific limitations, generalizability, and clinical implications are discussed. It is maintained within the EQUATOR Network and is now supported by the PROTEUS (Patient-Reported Outcomes Tools: Engaging Users and Stakeholders) consortium, with a companion protocol extension, SPIRIT-PRO (Calvert et al., JAMA 2018), governing the trial protocol stage.

When to use

Apply CONSORT-PRO when reporting the results of any randomized or pragmatic trial in which a PRO — health-related quality of life, symptom burden, functioning, treatment satisfaction, or another patient-reported construct — is a primary endpoint, a key secondary endpoint, or used in the label or value story. It is the relevant guideline for peer-reviewed publication, for the PRO sections of an HTA/payer dossier (where HRQoL and utility evidence drive cost-utility models), and for FDA/EMA submissions where PRO endpoints support labeling claims. Decision rule for choosing the right member of the family: use SPIRIT-PRO at the protocol stage and CONSORT-PRO at the trial-report stage; use the parent CONSORT 2010 when no PRO endpoint is in play; and if the PRO evidence comes from a non-randomized real-world study, CONSORT-PRO does not govern the design — pair PRO-measurement rigor with STROBE/RECORD-PE reporting and the RWE methods below. Within a registry-based or pragmatic randomized trial, CONSORT-PRO still applies because randomization is present.

What it requires

The substantive domains it enforces, framed for evidence that will face regulatory or HTA review: (1) PRO endpoint definition and hypothesis — the construct, the specific instrument and version, the recall period, the mode and schedule of administration, and a pre-stated hypothesis with the responder/minimally important difference threshold. (2) Instrument fitness-for-purpose — evidence of content validity, construct validity, reliability, and responsiveness in the target population, with citations rather than assertions. (3) Estimand and intercurrent-event thinking — what the PRO contrast actually estimates and how death, treatment discontinuation, and disease progression are handled (terminal events that truncate PRO collection are estimand-defining, not nuisance missingness). (4) Missing PRO data — the expected and observed completion rates by arm and timepoint, the missingness mechanism assumed, the primary analysis model, and sensitivity analyses under alternative (e.g., not-at-random) assumptions. (5) Multiplicity across domains/timepoints and the analysis of repeated PRO measures. (6) Interpretation — clinical meaning anchored to a justified threshold, generalizability, and PRO-specific limitations. It does not require code, a numeric score, or a verdict on study validity.

When NOT to use — limitations and common misapplications

CONSORT-PRO is a transparency instrument, so the predictable failures are: (a) treating the checklist as a risk-of-bias or quality assessment — a fully reported PRO trial can still be biased; completeness of reporting is not internal validity, and CONSORT-PRO is not RoB 2 or ROBINS-I. (b) Checklist-as-theater — pasting a completed checklist into supplementary material while the manuscript omits arm-specific completion rates or the assumed missingness mechanism. (c) Wrong member of the family — using CONSORT-PRO to appraise a single-arm or observational PRO study, where there is no randomization to report and STROBE plus PRO-measurement standards (and RECORD-PE for routinely collected data) are the correct frame. (d) Confusing CONSORT-PRO with SPIRIT-PRO — protocol content (sample-size justification for the PRO, data-collection plan, missing- data strategy specified a priori) belongs in SPIRIT-PRO; reporting after the fact belongs in CONSORT-PRO. (e) Ignoring terminal/intercurrent events — analyzing PRO change only among survivors who completed assessments silently changes the estimand and inflates apparent benefit; this is the single most common substantive failure CONSORT-PRO is meant to surface.

How it maps to this catalog

Each CONSORT-PRO requirement is implemented by a concept here. PRO instrument selection, validity, and responsiveness → pro-validation, pro-development, and hrqol (with qaly-utility-mapping-rwe when PRO/HRQoL feeds a cost-utility model for HTA). Estimand specification and intercurrent events (death, discontinuation, progression) → estimands-ate-att-intercurrent-events-rwe and estimand-analysis-traceability-rwe. Missing-data reporting and analysis → attrition-and-loss-to-follow-up-rwe, missing-data-pattern-table-rwe, multiple-imputation-longitudinal-rwe, and tipping-point-analysis-rwe for the not-at-random sensitivity analyses CONSORT-PRO asks for. Repeated-measures and longitudinal PRO modeling → mmrm-repeated-measures-rwe and longitudinal-outcomes-modeling-rwe. Composite or multi-domain PRO endpoints → composite-endpoint-construction-rwe. Baseline comparability of the randomized arms → baseline-characteristics-and-covariate-balance-rwe.

Applied note for claims/EHR/registry RWE

PROs are, by definition, collected directly from patients and are almost never present in administrative claims; EHRs capture them only sporadically and non-systematically (free-text notes, ad hoc questionnaires). In a registry-based or pragmatic randomized trial, CONSORT-PRO applies in full — but the report must be explicit that PRO ascertainment is visit-driven, so completion is tied to the same encounters that generate the routinely collected data, making missingness informative and arm-differential. Report PRO completion as a funnel by arm and timepoint, distinguish administrative censoring (disenrollment, end of registry follow-up) from non-response and from death, and pre-specify the estimand strategy for terminal events. Using a claims/EHR backbone to recruit and follow a PRO cohort does not make claims a PRO source: the patient-facing instrument and its validation evidence still carry the reporting burden.