> For the complete documentation index, see [llms.txt](https://www.parapathology.com/llms.txt). Markdown versions of documentation pages are available by appending `.md` to page URLs; this page is available as [Markdown](https://www.parapathology.com/writing-journal-articles/ai-study-appraisal.md).

# Appraising AI studies in pathology

Choose a reporting guideline or appraisal tool according to the study question. Reporting completeness, risk of bias, applicability, and demonstrated clinical benefit are separate judgments. A complete checklist does not by itself establish that a model works in another laboratory.

## Select the appropriate resource

| Resource   | Purpose                                                                                                    | Primary reference                                                                                     |
| ---------- | ---------------------------------------------------------------------------------------------------------- | ----------------------------------------------------------------------------------------------------- |
| TRIPOD+AI  | Reporting the development or evaluation of clinical prediction models using regression or machine learning | [Collins et al., BMJ 2024](https://doi.org/10.1136/bmj-2023-078378), PMID 38626948                    |
| PROBAST+AI | Assessing development quality, bias in performance evaluation, and applicability of prediction models      | [Moons et al., BMJ 2025](https://doi.org/10.1136/bmj-2024-082505), PMID 40127903                      |
| STARD-AI   | Reporting diagnostic-accuracy studies of AI-based tests                                                    | [Sounderajah et al., Nature Medicine 2025](https://doi.org/10.1038/s41591-025-03953-8), PMID 40954311 |
| DECIDE-AI  | Reporting early live clinical evaluation of AI decision-support systems                                    | [Vasey et al., BMJ 2022](https://doi.org/10.1136/bmj-2022-070904), PMID 35584845                      |

Use the current publisher versions and their checklists. The STARD-AI publisher page links an [author correction dated 13 July 2026](https://doi.org/10.1038/s41591-026-04570-9); this note does not reproduce the checklist or assess the correction's contents.

## Record the evidence before interpreting it

The following is a practical extraction worksheet for this vault, not an additional validated checklist. Mark unavailable details **not reported** or **not checked**, rather than treating them as absent by design.

| Item                       | What to record                                                                                                                                     |
| -------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------- |
| Source and version         | Title, authors, journal, publication date, DOI/PMID; preprint or peer-reviewed version; corrections checked                                        |
| Clinical question          | Intended use, target population, specimen type, setting, and current comparator                                                                    |
| Study design               | Development, internal or external validation, reader experiment, or live clinical evaluation; prospective data collection versus archived material |
| Sample and unit            | Patients, specimens, slides, regions, and tiles separately; institutions, scanners, stains, and relevant selection criteria                        |
| Reference standard         | Who supplied the labels, information available to readers, blinding, adjudication, and disagreement                                                |
| Data separation            | Patient and site overlap; training, tuning, and testing; preprocessing learned from test data; possible pretraining overlap                        |
| Results                    | Metric definition, denominator, operating threshold, confidence interval, and comparator; calibration and incremental value when relevant          |
| Human and workflow effects | Assisted and unassisted errors, incorrect-suggestion uptake, time, overrides, and cases the tool cannot process                                    |
| Appraisal                  | Applicable formal tool and domain judgments; distinguish not reported from demonstrably biased                                                     |
| Transfer and limitations   | External population differences, technical variation, conflicts of interest, unavailable data/code, and local validation needs                     |
| Interpretation             | What the result supports, what it does not establish, and the next evidence needed                                                                 |

## Record review progress

The existing `status` field describes editorial maturity (Stub, Developing, Evergreen). Use the separate `review_status` field when tracking evidence appraisal:

| Value        | Meaning                                                                                                   |
| ------------ | --------------------------------------------------------------------------------------------------------- |
| Pending      | Identified for appraisal; source and claims have not yet been checked                                     |
| Partial      | Some sources or claims checked; the body states the remaining work                                        |
| Reviewed     | The explicitly stated appraisal scope has been completed; limitations and domain judgments remain visible |
| Needs update | A previously reviewed scope needs reconsideration after new evidence, a correction, or a version change   |

Record `last_reviewed` as the date of the latest actual check, including a partial check. It is not a freshness guarantee. Add `doi`, `pmid`, and `study_design` when verified and appropriate to the note. Do not set a synthesis note's DOI to one of several papers as though it were the note's own publication.

A review record should state: **review date; sources/passages examined; claims checked; appraisal scope; unresolved questions**. Do not label an entire article critically appraised after verifying its identifier or abstract alone. The **Evidence to Review** saved view includes Clippings without a review status, notes marked Pending/Partial/Needs update, and Reviewed notes missing a review date. It does not automatically determine when an otherwise dated review has become stale.

## Review scope

On 28 September 2026, the identities and broad purposes of the four resources were checked through Life Sciences Literature and primary publisher records. This note provides a starting workflow; it does not reproduce all guideline items or claim that any linked study has completed formal appraisal. For worked applications and their current limitations, see \[\[digital-pathology-evidence]].
