medsci-skills 4.1.0

package/skills/check-reporting/references/checklists/RoB_NMA.md

@@ -0,0 +1,96 @@
+# RoB NMA Assessment Guide
+
+Risk of Bias in Network Meta-Analysis Tool, Version 1 (March 2024).
+Reference: Lunny C et al. Developed by the Knowledge Translation Foundation.
+Website: https://www.riskofbias.info
+
+## Purpose
+
+The RoB NMA tool identifies potential limitations in the way a **network meta-analysis (NMA)** was conducted, including aspects of how the evidence was assembled that may lead to bias in the NMA's results or conclusions.
+
+## Structure
+
+The tool contains **18 items** organized into 3 domains:
+1. Interventions and network geometry
+2. Effect modifiers
+3. Statistical synthesis
+
+Within each domain, signalling statements are evaluated.
+
+Response options: True (T) / Probably True (PT) / Probably False (PF) / False (F) / No Information (NI)
+
+Domain-level judgments: Low risk of bias / Some concerns / High risk of bias
+
+## Using ROBIS with the RoB NMA Tool
+
+The final phase combines:
+- RoB NMA domain judgments (for the NMA-specific aspects)
+- A systematic review-level quality judgment (e.g., using ROBIS or AMSTAR-2)
+
+This determines whether the **systematic review as a whole** is at risk of bias.
+
+## Domain 1: Interventions and Network Geometry
+
+Assesses whether all relevant interventions and comparators are included and whether the network structure is appropriate.
+
+### Signalling Statements
+1.1 All interventions and their comparators included in the NMA are reasonable alternatives for the whole target population
+1.2 The interventions and comparators are clearly defined (e.g., dose, frequency, duration)
+1.3 The network includes all important interventions that would inform clinical decision-making
+1.4 Studies were not selectively included based on which comparisons they evaluated
+1.5 The network geometry does not suggest that important comparisons are missing
+1.6 Node definitions are clinically meaningful and not arbitrarily lumped or split
+
+### Risk of Bias Judgment
+- **Low**: All signalling statements true or probably true
+- **Some concerns**: Some statements probably false but unlikely to materially affect conclusions
+- **High**: One or more statements false, likely to bias results
+
+## Domain 2: Effect Modifiers
+
+Assesses whether the distribution of effect modifiers is balanced across comparisons (transitivity assumption).
+
+### Signalling Statements
+2.1 The distribution of potential effect modifiers is similar across treatment comparisons
+2.2 Study characteristics (design, quality, sample size) are balanced across comparisons
+2.3 Patient characteristics (age, severity, comorbidities) are balanced across comparisons
+2.4 There is no evidence that the transitivity assumption is violated
+2.5 Potential sources of intransitivity have been identified and assessed
+2.6 Studies informing different comparisons are sufficiently similar to allow valid indirect comparisons
+
+### Risk of Bias Judgment
+- **Low**: Effect modifiers are balanced; transitivity assumption appears valid
+- **Some concerns**: Some imbalance in effect modifiers but unlikely to materially affect results
+- **High**: Clear imbalance in effect modifiers threatening the validity of indirect comparisons
+
+## Domain 3: Statistical Synthesis
+
+Assesses whether appropriate statistical methods were used for the NMA.
+
+### Signalling Statements
+3.1 An appropriate NMA model was used (e.g., Bayesian or frequentist, fixed or random effects)
+3.2 The model adequately accounts for heterogeneity (between-study variation)
+3.3 The consistency assumption was assessed (agreement between direct and indirect evidence)
+3.4 Methods for assessing inconsistency were appropriate (node-splitting, design-by-treatment interaction)
+3.5 Sensitivity analyses were conducted to examine the robustness of results
+3.6 The ranking of treatments was based on appropriate methods (SUCRA, P-score, mean ranks with uncertainty)
+
+### Risk of Bias Judgment
+- **Low**: Appropriate statistical methods used; consistency assessed
+- **Some concerns**: Minor methodological concerns unlikely to materially affect conclusions
+- **High**: Inappropriate methods or unaddressed inconsistency likely to bias results
+
+## Overall Risk of Bias
+
+Combine domain judgments:
+- **Low**: Low risk in all 3 domains
+- **Some concerns**: Some concerns in at least one domain, no high risk in any
+- **High**: High risk in at least one domain
+
+## When to Use
+
+- Assessing the quality of network meta-analyses
+- Guideline development involving multiple treatment comparisons
+- Overview of NMAs comparing different treatment networks
+- Complements individual study RoB tools (RoB 2, ROBINS-I) which assess primary studies within the NMA
+- Not for pairwise meta-analyses (use ROB-ME for missing evidence assessment)

package/skills/check-reporting/references/checklists/SPIRIT.md

@@ -0,0 +1,112 @@
+# SPIRIT 2025 Checklist
+
+**Standard Protocol Items: Recommendations for Interventional Trials**
+Version: SPIRIT 2025
+Source: https://www.consort-spirit.org
+Reference: Chan AW, Hopewell S, Moher D, et al. SPIRIT 2025 statement: updated guideline for protocols of randomised trials. BMJ 2025;389:e081477 (published simultaneously in BMJ, JAMA, Lancet, Nature Medicine, PLoS Medicine).
+
+> Note: SPIRIT 2025 supersedes SPIRIT 2013. It is a 34-item checklist (two new items, five revised, five deleted/merged) restructured with a new Open Science section. Use for clinical trial *protocols* (CONSORT is for the completed trial report).
+
+## Checklist Items (34 items)
+
+### Administrative Information
+
+| # | Item | Description |
+|---|------|-------------|
+| 1a | Title | Title stating the trial design, population, and interventions, with identification as a protocol. |
+| 1b | Abstract | Structured summary of trial design and methods, including items from the World Health Organization Trial Registration Data Set. |
+| 2 | Protocol version | Version date and identifier. |
+| 3a | Roles — contributors | Names, affiliations, and roles of protocol contributors. |
+| 3b | Roles — sponsor contact | Name and contact information for the trial sponsor. |
+| 3c | Roles — sponsor role | Role of trial sponsor and funders in design, conduct, analysis, and reporting of trial; including any authority over these activities. |
+| 3d | Roles — committees | Composition, roles, and responsibilities of the coordinating site, steering committee, endpoint adjudication committee, data management team, and other individuals or groups overseeing the trial, if applicable. |
+
+### Open Science
+
+| # | Item | Description |
+|---|------|-------------|
+| 4 | Trial registration | Name of trial registry, identifying number (with URL), and date of registration. If not yet registered, name of intended registry. |
+| 5 | Protocol and SAP | Where the trial protocol and statistical analysis plan can be accessed. |
+| 6 | Data, code, materials | Where and how the individual de-identified participant data (including data dictionary), statistical code, and any other materials will be accessible. |
+| 7a | Funding | Sources of funding and other support (e.g., supply of drugs). |
+| 7b | Conflicts of interest | Financial and other conflicts of interest for principal investigators and steering committee members. |
+| 8 | Dissemination | Plans to communicate trial results to participants, healthcare professionals, the public, and other relevant groups (e.g., reporting in trial registry, plain language summary, publication). |
+
+### Introduction
+
+| # | Item | Description |
+|---|------|-------------|
+| 9a | Background | Scientific background and rationale, including summary of relevant studies (published and unpublished) examining benefits and harms for each intervention. |
+| 9b | Comparator choice | Explanation for choice of comparator. |
+| 10 | Objectives | Specific objectives related to benefits and harms. |
+
+### Methods: Patient and Public Involvement, Trial Design
+
+| # | Item | Description |
+|---|------|-------------|
+| 11 | Patient and public involvement | Details of, or plans for, patient or public involvement in the design, conduct, and reporting of the trial. |
+| 12 | Trial design | Description of trial design including type of trial (e.g., parallel group, crossover), allocation ratio, and framework (e.g., superiority, equivalence, non-inferiority, exploratory). |
+
+### Methods: Participants, Interventions, and Outcomes
+
+| # | Item | Description |
+|---|------|-------------|
+| 13 | Study setting | Settings (e.g., community, hospital) and locations (e.g., countries, sites) where the trial will be conducted. |
+| 14a | Eligibility — participants | Eligibility criteria for participants. |
+| 14b | Eligibility — sites/deliverers | If applicable, eligibility criteria for sites and for individuals who will deliver the interventions (e.g., surgeons, physiotherapists). |
+| 15a | Interventions — description | Intervention and comparator with sufficient details to allow replication including how, when, and by whom they will be administered. If relevant, where additional materials describing the intervention and comparator (e.g., intervention manual) can be accessed. |
+| 15b | Interventions — modifications | Criteria for discontinuing or modifying allocated intervention/comparator for a trial participant (e.g., drug dose change in response to harms, participant request, or improving/worsening disease). |
+| 15c | Interventions — adherence | Strategies to improve adherence to intervention/comparator protocols, if applicable, and any procedures for monitoring adherence (e.g., drug tablet return, sessions attended). |
+| 15d | Interventions — concomitant care | Concomitant care that is permitted or prohibited during the trial. |
+| 16 | Outcomes | Primary and secondary outcomes, including the specific measurement variable (e.g., systolic blood pressure), analysis metric (e.g., change from baseline, final value, time to event), method of aggregation (e.g., median, proportion), and time point for each outcome. |
+| 17 | Harms | How harms are defined and will be assessed (e.g., systematically, non-systematically). |
+| 18 | Participant timeline | Time schedule of enrolment, interventions (including any run-ins and washouts), assessments, and visits for participants. A schematic diagram is highly recommended. |
+| 19 | Sample size | How sample size was determined, including all assumptions supporting the sample size calculation. |
+| 20 | Recruitment | Strategies for achieving adequate participant enrolment to reach target sample size. |
+
+### Methods: Assignment of Interventions
+
+| # | Item | Description |
+|---|------|-------------|
+| 21a | Allocation — sequence | Who will generate the random allocation sequence and the method used. |
+| 21b | Allocation — restriction | Type of randomisation (simple or restricted) and details of any factors for stratification. To reduce predictability, other details of any planned restriction (e.g., blocking) should be provided in a separate document unavailable to those who enrol participants or assign interventions. |
+| 22 | Allocation concealment | Mechanism used to implement the random allocation sequence (e.g., central computer/telephone; sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence until interventions are assigned. |
+| 23 | Implementation | Whether the personnel who will enrol and those who will assign participants to the interventions will have access to the random allocation sequence. |
+| 24a | Blinding — who | Who will be blinded after assignment to interventions (e.g., participants, care providers, outcome assessors, data analysts). |
+| 24b | Blinding — how | If blinded, how blinding will be achieved and description of the similarity of interventions. |
+| 24c | Blinding — unblinding | If blinded, circumstances under which unblinding is permissible, and procedure for revealing a participant's allocated intervention during the trial. |
+
+### Methods: Data Collection, Management, and Analysis
+
+| # | Item | Description |
+|---|------|-------------|
+| 25a | Data collection | Plans for assessment and collection of trial data, including any related processes to promote data quality (e.g., duplicate measurements, training of assessors) and a description of trial instruments (e.g., questionnaires, laboratory tests) along with their reliability and validity, if known. Reference to where data collection forms can be accessed, if not in the protocol. |
+| 25b | Retention | Plans to promote participant retention and complete follow-up, including list of any outcome data to be collected for participants who discontinue or deviate from intervention protocols. |
+| 26 | Data management | Plans for data entry, coding, security, and storage, including any related processes to promote data quality (e.g., double data entry; range checks for data values). Reference to where details of data management procedures can be accessed, if not in the protocol. |
+| 27a | Statistical methods | Statistical methods used to compare groups for primary and secondary outcomes, including harms. |
+| 27b | Analysis populations | Definition of who will be included in each analysis (e.g., all randomised participants), and in which group. |
+| 27c | Missing data | How missing data will be handled in the analysis. |
+| 27d | Additional analyses | Methods for any additional analyses (e.g., subgroup and sensitivity analyses). |
+
+### Methods: Monitoring
+
+| # | Item | Description |
+|---|------|-------------|
+| 28a | Data monitoring committee | Composition of data monitoring committee (DMC); summary of its role and reporting structure; statement of whether it is independent from the sponsor and funder; conflicts of interest and reference to where further details about its charter can be found, if not in the protocol. Alternatively, an explanation of why a DMC is not needed. |
+| 28b | Interim analyses | Explanation of any interim analyses and stopping guidelines, including who will have access to these interim results and make the final decision to terminate the trial. |
+| 29 | Trial monitoring | Frequency and procedures for monitoring trial conduct. If there is no monitoring, give explanation. |
+
+### Ethics and Dissemination
+
+| # | Item | Description |
+|---|------|-------------|
+| 30 | Research ethics approval | Plans for seeking research ethics committee/institutional review board approval. |
+| 31 | Protocol amendments | Plans for communicating important protocol modifications to relevant parties. |
+| 32a | Consent | Who will obtain informed consent or assent from potential trial participants or authorised proxies, and how. |
+| 32b | Ancillary consent | Additional consent provisions for collection and use of participant data and biological specimens in ancillary studies, if applicable. |
+| 33 | Confidentiality | How personal information about potential and enrolled participants will be collected, shared, and maintained in order to protect confidentiality before, during, and after the trial. |
+| 34 | Ancillary and post-trial care | Provisions, if any, for ancillary and post-trial care, and for compensation to those who suffer harm from trial participation. |
+
+---
+
+*Educational summary of the SPIRIT 2025 checklist (CC BY 4.0). Cite the original statement (Chan et al., BMJ 2025) and consult https://www.consort-spirit.org for the authoritative, full checklist with explanation and elaboration.*

package/skills/check-reporting/references/checklists/SQUIRE_2.md

@@ -0,0 +1,68 @@
+# SQUIRE 2.0 Checklist
+
+**Standards for QUality Improvement Reporting Excellence 2.0**
+Version: SQUIRE 2.0 (2015)
+Source: http://squire-statement.org
+Reference: Ogrinc G, Davies L, Goodman D, Batalden P, Davidoff F, Stevens D. SQUIRE 2.0 (Standards for QUality Improvement Reporting Excellence): revised publication guidelines from a detailed consensus process. BMJ Qual Saf. 2016;25(12):986-992. doi:10.1136/bmjqs-2015-004411
+
+## Checklist Items (18 items)
+
+### Title and Abstract
+
+| # | Item | Description |
+|---|------|-------------|
+| 1 | Title | Indicate that the manuscript concerns an initiative to improve healthcare (broadly defined to include the quality, safety, or value of care). |
+| 2 | Abstract | a) Provide adequate information to aid in searching and indexing. b) Summarize all key information from each section of the text. |
+
+### Introduction
+
+| # | Item | Description |
+|---|------|-------------|
+| 3 | Problem description | Nature and significance of the local problem. |
+| 4 | Available knowledge | Summary of what is currently known about the problem, including relevant previous studies. |
+| 5 | Rationale | Informal or formal frameworks, models, concepts, and/or theories used to explain the problem, any reasons or assumptions that were used to develop the intervention(s), and reasons why the intervention(s) was expected to work. |
+| 6 | Specific aims | Purpose of the project and of this report. |
+
+### Methods
+
+| # | Item | Description |
+|---|------|-------------|
+| 7 | Context | Contextual elements considered important at the outset of introducing the intervention(s). |
+| 8 | Intervention(s) | a) Description of the intervention(s) in sufficient detail that others could reproduce it. b) Specifics of the team involved in the work. |
+| 9 | Study of the intervention(s) | a) Approach chosen for assessing the impact of the intervention(s). b) Approach used to establish whether the observed outcomes were due to the intervention(s). |
+| 10 | Measures | a) Measures chosen for studying processes and outcomes of the intervention(s), including rationale for choosing them, their operational definitions, and their validity and reliability. b) Description of the approach to the ongoing assessment of contextual elements that contributed to the success, failure, efficiency, and cost. c) Methods employed for assessing completeness and accuracy of data. |
+| 11 | Analysis | a) Qualitative and quantitative methods used to draw inferences from the data. b) Methods for understanding variation within the data, including the effects of time as a variable. |
+| 12 | Ethical considerations | Ethical aspects of implementing and studying the intervention(s) and how they were addressed, including, but not limited to, formal ethics review and potential conflict(s) of interest. |
+
+### Results
+
+| # | Item | Description |
+|---|------|-------------|
+| 13 | Results | a) Initial steps of the intervention(s) and their evolution over time, including modifications made to the intervention during the project. b) Details of the process measures and outcome. c) Contextual elements that interacted with the intervention(s). d) Observed associations between outcomes, interventions, and relevant contextual elements. e) Unintended consequences such as unexpected benefits, problems, failures, or costs associated with the intervention(s). f) Details about missing data. |
+
+### Discussion
+
+| # | Item | Description |
+|---|------|-------------|
+| 14 | Summary | a) Key findings, including relevance to the rationale and specific aims. b) Particular strengths of the project. |
+| 15 | Interpretation | a) Nature of the association between the intervention(s) and the outcomes. b) Comparison of results with findings from other publications. c) Impact of the project on people and systems. d) Reasons for any differences between observed and anticipated outcomes, including the influence of context. e) Costs and strategic trade-offs, including opportunity costs. |
+| 16 | Limitations | a) Limits to the generalizability of the work. b) Factors that might have limited internal validity such as confounding, bias, or imprecision in the design, methods, measurement, or analysis. c) Efforts made to minimize and adjust for limitations. |
+| 17 | Conclusions | a) Usefulness of the work. b) Sustainability. c) Potential for spread to other contexts. d) Implications for practice and for further study in the field. e) Suggested next steps. |
+
+### Other Information
+
+| # | Item | Description |
+|---|------|-------------|
+| 18 | Funding | Sources of funding that supported this work. Role, if any, of the funding organization in the design, implementation, interpretation, and reporting. |
+
+---
+
+## Notes for Assessors
+
+- SQUIRE 2.0 is designed for studies evaluating quality improvement interventions in healthcare, including medical education QI initiatives.
+- Not all items will be relevant to every QI study. Items should be assessed in the context of the specific improvement effort.
+- Item 13 (Results) has 6 sub-items (a-f). Assess each sub-item separately for comprehensive evaluation.
+- Items 5 (Rationale) and 9 (Study of the intervention) are critical for distinguishing QI reports from simple descriptions of implementation.
+- For educational quality improvement studies, "intervention" refers to the educational program, curriculum change, or training initiative being evaluated.
+- SQUIRE 2.0 applies to systematic efforts to improve the quality, safety, and value of healthcare; it is not intended for basic science or clinical trials (use CONSORT for RCTs).
+- The original SQUIRE guidelines (1.0) were published in 2008. SQUIRE 2.0 (2015) is the current version and should be used for all new submissions.

package/skills/check-reporting/references/checklists/STARD.md

@@ -0,0 +1,129 @@
+# STARD 2015 Checklist
+
+**Standards for Reporting of Diagnostic Accuracy Studies**
+Version: STARD 2015
+Source: https://www.stard-statement.org
+
+## Checklist Items (30 items)
+
+### Title and Abstract
+
+| # | Item | Description |
+|---|------|-------------|
+| 1 | Title | Identification as a study of diagnostic accuracy using at least one measure of accuracy (such as sensitivity, specificity, predictive values, or AUC). |
+| 2 | Abstract | Structured abstract with: study design, methods (participants, index test, reference standard), results (number of participants, estimates of diagnostic accuracy with confidence intervals), conclusions. |
+
+### Introduction
+
+| # | Item | Description |
+|---|------|-------------|
+| 3 | Scientific background | Scientific and clinical background, including the intended use and clinical role of the index test. |
+| 4 | Objectives | Study objectives and hypotheses. |
+
+### Methods
+
+#### Participants
+
+| # | Item | Description |
+|---|------|-------------|
+| 5 | Study design | Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study). |
+| 6 | Eligibility criteria | Eligibility criteria: inclusion and exclusion criteria, settings and locations where data were collected. |
+| 7 | Sampling | Whether participants formed a consecutive, random, or convenience series. |
+
+#### Test Methods
+
+| # | Item | Description |
+|---|------|-------------|
+| 8a | Index test | Index test, in sufficient detail to allow replication. |
+| 8b | Reference standard | Reference standard, in sufficient detail to allow replication. |
+| 9 | Rationale for reference standard | Rationale for choosing the reference standard (if alternatives exist). |
+| 10a | Pre-specification | Definition of and rationale for test positivity cut-offs or result categories of the index test, distinguishing pre-specified from exploratory. |
+| 10b | Pre-specification | Definition of and rationale for test positivity cut-offs or result categories of the reference standard, distinguishing pre-specified from exploratory. |
+| 11 | Blinding | Whether clinical information and reference standard results were available to the performers/readers of the index test and vice versa. |
+| 12 | Additional analyses | Methods for estimating or comparing measures of diagnostic accuracy. Methods for calculating test reproducibility, if done. |
+| 13 | Sample size | How the sample size was determined (power analysis, convenience, or other rationale). |
+
+### Results
+
+#### Participants
+
+| # | Item | Description |
+|---|------|-------------|
+| 14 | Dates and setting | When the study was done, including beginning and end dates of recruitment. |
+| 15 | Demographics | Clinical and demographic characteristics of participants (age, sex, disease spectrum, comorbidities, current treatments, recruitment centers). |
+| 16 | Participant numbers | The number of participants satisfying the criteria for inclusion who did or did not undergo the index test and/or the reference standard; describe why participants failed to receive either test (a flow diagram is strongly recommended). |
+
+#### Test Results
+
+| # | Item | Description |
+|---|------|-------------|
+| 17 | Time interval | Time interval and any clinical interventions between index test and reference standard. |
+| 18 | Distribution of severity | Distribution of severity of disease in those with the target condition; distribution of alternative diagnoses in those without the target condition. |
+| 19 | Cross-tabulation | A cross tabulation of the index test results (or their distribution) by the results of the reference standard. |
+| 20 | Indeterminate results | Any adverse events from performing the index test or the reference standard. |
+| 21 | Accuracy estimates | Estimates of diagnostic accuracy and their precision (such as 95% confidence intervals). |
+| 22 | Handling of indeterminate | How indeterminate index test or reference standard results were handled. |
+| 23 | Subgroup analyses | Any analyses of variability in diagnostic accuracy, distinguishing pre-specified from exploratory (subgroup analyses by age, sex, disease severity, etc.). |
+
+### Discussion
+
+| # | Item | Description |
+|---|------|-------------|
+| 24 | Study limitations | Study limitations, including sources of potential bias, statistical uncertainty, and generalisability. |
+| 25 | Clinical applicability | Implications for practice, including the intended use and clinical role of the index test. |
+
+### Other Information
+
+| # | Item | Description |
+|---|------|-------------|
+| 26 | Registration | Registration number and name of registry. |
+| 27 | Protocol | Where the full study protocol can be accessed. |
+| 28 | Funding | Sources of funding and other support; role of funders. |
+
+---
+
+## STARD Flow Diagram
+
+The STARD flow diagram is **strongly recommended** (item 16). It should show:
+
+```
+Eligible patients (N = ?)
+  |
+  v
+Enrolled (N = ?)
+  |
+  +-- Did not receive index test (N = ?, reasons)
+  |
+  v
+Received index test (N = ?)
+  |
+  +-- Did not receive reference standard (N = ?, reasons)
+  |
+  v
+Received both index test AND reference standard (N = ?)
+  |
+  +-- Index test results:
+  |     Positive (N = ?)
+  |     Negative (N = ?)
+  |     Inconclusive (N = ?)
+  |
+  +-- Reference standard results:
+        Target condition present (N = ?)
+        Target condition absent (N = ?)
+```
+
+---
+
+## STARD-AI Extension
+
+For studies evaluating AI-based diagnostic tests, use the dedicated **STARD-AI checklist** (`STARD_AI.md`) instead of this file. STARD-AI (Sounderajah et al., Nat Med 2025) provides a comprehensive 40-item checklist that incorporates all STARD 2015 items plus 14 new and 4 modified AI-specific items. Do NOT apply both STARD 2015 and STARD-AI simultaneously.
+
+---
+
+## Notes for Assessors
+
+- Item 16 (flow diagram): if not provided as a figure, check whether the same information is conveyed in the text.
+- Item 11 (blinding): in retrospective studies with AI, consider whether the AI had access to clinical information beyond the intended input.
+- Item 19 (cross-tabulation): a 2x2 table is the minimum; report TP, FP, TN, FN counts.
+- Items 26-27 (registration/protocol): many diagnostic accuracy studies are not registered, but this is increasingly expected. Mark as MISSING if absent, with a note that registration is recommended.
+- For AI studies, use the dedicated STARD-AI checklist (`STARD_AI.md`).

package/skills/check-reporting/references/checklists/STARD_AI.md

@@ -0,0 +1,211 @@
+# STARD-AI Checklist
+
+**Standards for Reporting of Diagnostic Accuracy Studies — Artificial Intelligence**
+Version: STARD-AI 2025
+Source: https://doi.org/10.1038/s41591-025-03953-8
+
+**Reference:** STARD-AI Steering Committee, STARD-AI Consensus Group, Sounderajah V, Guni A, Liu X, Collins GS, Karthikesalingam A, Markar SR, Golub RM, Denniston AK, Shetty S, Moher D, Bossuyt PM, Darzi A, Ashrafian H. The STARD-AI reporting guideline for diagnostic accuracy studies using artificial intelligence. Nat Med. 2025;31:3283-3289. PMID: 40954311
+
+**License:** Creative Commons Attribution (CC BY)
+
+**Scope:** AI-centred diagnostic test accuracy studies. Applies to studies evaluating the diagnostic accuracy of AI systems including machine learning, deep learning models, natural language processing tools, and foundation models that generate or support diagnostic outputs. Does NOT apply to static/manually programmed rule-based systems or simple decision trees.
+
+**Relationship to STARD 2015:** STARD-AI extends STARD 2015 (Bossuyt et al. BMJ 2015). Of the 40 items, 22 are UNCHANGED from STARD 2015, 4 are MODIFIED, and 14 are NEW. Items are numbered to maintain alignment with STARD 2015 where possible.
+
+**Relationship to other guidelines:**
+- CONSORT-AI: for clinical trials of AI interventions
+- SPIRIT-AI: for trial protocols involving AI
+- TRIPOD+AI: for AI prediction/prognostic models
+- CLAIM 2024: for AI/ML in medical imaging
+- Use STARD-AI when diagnostic accuracy of an AI system is the primary focus
+
+---
+
+## Checklist Items (40 items; items 15, 16, 17, 26, and 40 have sub-items)
+
+### Title and Abstract
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 1 | Title | Identification as a study reporting AI-centered diagnostic accuracy and reporting at least one measure of accuracy within title or abstract. | MODIFIED |
+| 2 | Abstract | Structured summary of study design, methods, results and conclusions (for specific guidance, see STARD for Abstracts). | UNCHANGED |
+
+### Introduction
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 3 | Scientific background | Scientific and clinical background, including the intended use of the index test, whether it is novel or an established index test and its integration into an existing or new workflow, if applicable. | MODIFIED |
+| 4 | Objectives | Study objectives and hypotheses. | UNCHANGED |
+
+### Methods
+
+#### Study Design
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 5 | Study design | Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study). | UNCHANGED |
+
+#### Ethics
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 6 | Ethics approval | Formal approval from an ethics committee. If not required, justify why. | NEW |
+
+#### Participants
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 7 | Eligibility criteria | Eligibility criteria: listing separate inclusion and exclusion criteria in the order that they are applied at both participant level and data level. | MODIFIED |
+| 8 | Participant identification basis | On what basis potentially eligible participants were identified (such as symptoms, results from previous tests and inclusion in registry). | UNCHANGED |
+| 9 | Setting and dates | Where and when potentially eligible participants were identified (setting, location and dates). | UNCHANGED |
+| 10 | Participant series | Whether participants formed a consecutive, random or convenience series. | UNCHANGED |
+
+#### Dataset
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 11 | Data source | Source of the data and whether they have been routinely collected, specifically collected for the purpose of the study or acquired from an open-source repository. | NEW |
+| 12 | Dataset annotation | Who undertook the annotations for the dataset (including experience levels and background) and how (within the same clinical context or in a post hoc fashion), if applicable. | NEW |
+| 13 | Data capture devices and software | Devices (manufacturer and model) that were used to capture data; software (with version number) used to engineer the index test, highlighting the intended use. | NEW |
+| 14 | Data acquisition and preprocessing | Data acquisition protocols (for example, contrast protocol or reconstruction method for medical images) and details of data preprocessing, in sufficient detail to allow replication. | NEW |
+
+#### Test Methods
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 15a | Index test | Index test, in sufficient detail to allow replication. | UNCHANGED |
+| 15b | Index test development | How the index test was developed, including any training, validation, testing and external evaluation, detailing sample sizes, when applicable. | NEW |
+| 15c | Index test cut-offs | Definition of and rationale for test positivity cutoffs or result categories of the index test, distinguishing prespecified from exploratory. | UNCHANGED |
+| 15d | End-user specification | The specified end-user of the index test and the level of expertise required of users. | NEW |
+| 16a | Reference standard | Reference standard, in sufficient detail to allow replication. | UNCHANGED |
+| 16b | Reference standard rationale | Rationale for choosing the reference standard (if alternatives exist). | UNCHANGED |
+| 16c | Reference standard cut-offs | Definition of and rationale for test positivity cutoffs or result categories of the reference standard, distinguishing prespecified from exploratory. | UNCHANGED |
+| 17a | Blinding (index test) | Whether clinical information and reference standard results were available to the performers or readers of the index test. | UNCHANGED |
+| 17b | Blinding (reference standard) | Whether clinical information and index test results were available to the assessors of the reference standard. | UNCHANGED |
+
+#### Analysis
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 18 | Statistical methods | Methods for estimating or comparing measures of diagnostic accuracy. | UNCHANGED |
+| 19 | Indeterminate results | How indeterminate index test or reference standard results were handled. | UNCHANGED |
+| 20 | Missing data | How missing data on the index test and reference standard were handled. | UNCHANGED |
+| 21 | Variability analyses | Any analyses of variability in diagnostic accuracy, distinguishing prespecified from exploratory. | UNCHANGED |
+| 22 | Sample size | Intended sample size and how it was determined. | UNCHANGED |
+| 23 | Fairness assessment (methods) | Details of any performance error analysis and algorithmic bias and fairness assessments, if undertaken. | NEW |
+
+### Results
+
+#### Participants and Dataset
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 24 | Flow diagram | Flow of participants, using a diagram. | UNCHANGED |
+| 25 | Baseline characteristics | Baseline demographic, clinical and technical characteristics of training, validation and test sets, if applicable. | MODIFIED |
+| 26a | Distribution of severity | Distribution of severity of disease in those with the target condition. | UNCHANGED |
+| 26b | Alternative diagnoses | Distribution of alternative diagnoses in those without the target condition. | UNCHANGED |
+| 27 | Time interval | Time interval and any clinical interventions between index test and reference standard. | UNCHANGED |
+| 28 | Test set representativeness | Whether the datasets represent the distribution of the target condition that one would expect from the intended use population. | NEW |
+| 29 | External evaluation differences | For external evaluation on an independent dataset, an assessment of how this differs from the training, validation and test sets. | NEW |
+
+#### Test Results
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 30 | Cross-tabulation | Cross-tabulation of the index test results (or their distribution) by the results of the reference standard. | UNCHANGED |
+| 31 | Accuracy estimates | Estimates of diagnostic accuracy and their precision (such as 95% confidence intervals). | UNCHANGED |
+| 32 | Adverse events | Any adverse events from performing the index test or the reference standard. | UNCHANGED |
+
+### Discussion
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 33 | Study limitations | Study limitations, including sources of potential bias, statistical uncertainty and generalizability. | UNCHANGED |
+| 34 | Clinical applicability | Implications for practice, including the intended use and clinical role of the index test. | UNCHANGED |
+| 35 | Ethical considerations and fairness | Ethical considerations and adherence to ethical standards associated with the use of the index test and issues of fairness. | NEW |
+
+### Other Important Information
+
+| # | Item | Description | Status vs STARD 2015 |
+|---|------|-------------|---------------------|
+| 36 | Registration | Registration number and name of registry. | UNCHANGED |
+| 37 | Protocol | Where the full study protocol can be accessed. | UNCHANGED |
+| 38 | Funding | Sources of funding and other support; role of funders. | UNCHANGED |
+| 39 | Commercial interests | Commercial interests, if applicable. | NEW |
+| 40a | Data and code availability | Availability of datasets and code, detailing any restrictions on their reuse and repurposing. | NEW |
+| 40b | Audit and evaluation | Whether outputs are stored, auditable and available for evaluation, if necessary. | NEW |
+
+---
+
+## Summary of Changes from STARD 2015
+
+### MODIFIED Items (4)
+
+| STARD-AI Item | Change Summary |
+|---------------|---------------|
+| 1 (Title) | Added requirement to identify the study as AI-centered diagnostic accuracy |
+| 3 (Introduction) | Added requirement for intended use, novelty, and workflow integration |
+| 7 (Eligibility criteria) | Expanded to include eligibility at both participant and data level |
+| 25 (Baseline characteristics) | Expanded to include characteristics of training, validation, and test sets |
+
+### NEW Items (14)
+
+| STARD-AI Item | Topic |
+|---------------|-------|
+| 6 | Ethics approval |
+| 11 | Data source and collection method |
+| 12 | Dataset annotation |
+| 13 | Data capture devices and software |
+| 14 | Data acquisition and preprocessing |
+| 15b | Index test development (training, validation, testing) |
+| 15d | End-user specification and expertise level |
+| 23 | Fairness assessment methods |
+| 28 | Test set representativeness |
+| 29 | External evaluation differences |
+| 35 | Ethical considerations and fairness |
+| 39 | Commercial interests |
+| 40a | Data and code availability |
+| 40b | Audit and evaluation of outputs |
+
+---
+
+## Notes for Assessors
+
+### When to Use STARD-AI vs Other AI Guidelines
+
+- **STARD-AI**: When the study evaluates diagnostic accuracy of an AI system as the primary outcome. Includes imaging AI, LLM-based diagnostic tools, pathology AI, EHR-based diagnostic systems.
+- **TRIPOD+AI / TRIPOD-LLM**: When the study develops or validates a prediction/prognostic model using AI/ML.
+- **CLAIM 2024**: When the study develops or validates an AI model specifically for medical imaging.
+- **CONSORT-AI**: When the study is a clinical trial of an AI intervention.
+- Authors may refer to multiple checklists and select the one most aligned with the study's primary aim.
+
+### Key Assessment Points
+
+1. **Item 1 (Title)**: The title must explicitly identify the study as reporting AI-centered diagnostic accuracy. Merely mentioning "machine learning" or "deep learning" without connecting it to diagnostic accuracy is PARTIAL.
+2. **Item 7 (Eligibility)**: STARD-AI requires eligibility criteria at BOTH participant level (e.g., age, diagnosis) AND data level (e.g., image quality, scanner type). Reporting only participant-level criteria is PARTIAL.
+3. **Item 12 (Annotation)**: Must include who annotated, their experience levels and background, and how (within clinical context or post hoc). Missing any of these elements is PARTIAL.
+4. **Item 14 (Data acquisition)**: Must describe data acquisition protocols and preprocessing in sufficient detail to allow replication.
+5. **Item 23 & 35 (Fairness/Ethics)**: These are paired items — methods/assessment in Item 23, ethical considerations and fairness discussion in Item 35. Both must be present. If the study claims fairness was not assessed, this should be explicitly stated with justification.
+6. **Item 25 (Baseline characteristics)**: For AI studies, characteristics must be reported for EACH dataset partition (training, validation, test), not just overall.
+7. **Items 39-40b (Other information)**: Commercial interests (39), data/code availability (40a), and audit/evaluation (40b) are NEW and commonly missing. These are increasingly required by journals.
+
+### Relationship to MI-CLEAR-LLM
+
+If the AI system under evaluation is an LLM (e.g., GPT-4, Claude, Gemini), apply MI-CLEAR-LLM (6 items) alongside STARD-AI. MI-CLEAR-LLM addresses LLM-specific concerns (stochasticity, prompt documentation, data contamination) that are not covered by STARD-AI.
+
+### Common Gaps in AI Diagnostic Accuracy Studies
+
+Based on the systematic review that informed STARD-AI development (Aggarwal et al. npj Digit Med 2021):
+1. Missing annotation process details
+2. Missing data preprocessing description
+3. No fairness/bias assessment
+4. No external validation or test set representativeness discussion
+5. Missing model architecture and training details
+6. No commercial interest disclosure
+7. No data/code availability statement
+
+---
+
+## Verification Note
+
+This checklist was verified against the published Table 2 of the STARD-AI paper in Nature Medicine (2025;31:3283-3289, DOI: 10.1038/s41591-025-03953-8). Item numbering, descriptions, and NEW/MODIFIED/UNCHANGED classifications match the published version. Verified 2026-04-11 via Nature Medicine online full-size Table 2 (https://www.nature.com/articles/s41591-025-03953-8/tables/2) and STARD 2015 checklist (EQUATOR Network). The STARD 2015 original checklist (Bossuyt et al. BMJ 2015) was used to confirm UNCHANGED items.