heor-agent-mcp 1.0.2 → 1.0.4

package/README.md

@@ -12,6 +12,21 @@ Built for pharmaceutical, biotech, CRO, and medical affairs teams who need rigor
 
 ---
 
+## What's new in v1.0.4
+
+Senior HEOR methodology + ChatGPT support:
+
+- **GRADE inconsistency now uses I²** instead of study count. Single-study comparisons return `not_assessable` (per Cochrane 10.10) instead of being silently auto-downgraded as "Serious". Pass `heterogeneity_per_outcome` to `hta_dossier` and the Cochrane bands (50–74% Moderate, 75–89% Serious, ≥90% Very Serious) are applied directly.
+- **GRADE upgrading (Guyatt 2011)** — observational evidence with strong effects can now be upgraded from Low. Three criteria via `upgrading_per_outcome`: large effect (RR <0.5/>2.0 → +1; <0.2/>5.0 → +2), dose-response (+1), plausible confounding biasing toward null (+1). Capped at +2.
+- **Bucher consistency check** — when direct head-to-head A-vs-C evidence exists alongside the indirect A-vs-C estimate, `evidence_indirect` automatically tests Bucher's consistency assumption and flags violations (NICE DSU TSD 18). |z|≥1.96 = "substantial — consistency assumption appears violated."
+- **EQ-5D 5L impact is baseline-utility-aware.** Biz 2026 reports category-level medians, but the new 5L value set compresses utilities in the 0.6–0.9 range — a drug for mild plaque psoriasis (baseline ~0.85) sees a much bigger ICER increase than one for severe HS (baseline ~0.45), even though both are `non_cancer_qol_only`. Pass `baseline_utility` to `utility_value_set` for a calibrated estimate.
+- **ChatGPT Custom GPT support** — new OpenAPI 3.1 adapter at `/api/openapi` lets you build a Custom GPT in 5 minutes. See [ChatGPT Custom GPT](#chatgpt-custom-gpt) below.
+- **Surface-tagged analytics** — every `tool_call` PostHog event now carries a `surface` property (`claude_anthropic_web` / `chatgpt_adapter` / `claude_desktop` / `direct_mcp`) so you can break down usage by client.
+
+See [CHANGELOG.md](./CHANGELOG.md) for the full diff.
+
+---
+
 ## Quick Start
 
 ### Claude Code
@@ -45,15 +60,23 @@ Add to your MCP configuration:
 
 ---
 
-## Tools
+## Tools (17)
 
 | Tool | Purpose |
 |------|---------|
-| `literature_search` | Search 42 data sources with a full PRISMA-style audit trail |
+| `literature_search` | Search 44 data sources with a full PRISMA-style audit trail |
 | `screen_abstracts` | PICO-based relevance scoring and study design classification |
 | `risk_of_bias` | Cochrane RoB 2 / ROBINS-I / AMSTAR-2 with GRADE RoB domain summary |
-| `cost_effectiveness_model` | Markov / PartSA / decision-tree CEA with PSA, OWSA, CEAC, EVPI |
-| `hta_dossier_prep` | Draft submissions for NICE, EMA, FDA, IQWiG, HAS, and EU JCA — GRADE table uses structured RoB when `rob_results` passed |
+| `evidence_network` | Build treatment comparison network and assess NMA feasibility |
+| `evidence_indirect` | Bucher and frequentist NMA with **automatic consistency check** vs direct h2h evidence (NICE DSU TSD 18) |
+| `population_adjusted_comparison` | MAIC and STC for population-adjusted indirect comparisons |
+| `survival_fitting` | Fit 5 parametric distributions to KM data (NICE DSU TSD 14) |
+| `itc_feasibility` | Assess the 3-assumption ITC framework and recommend Bucher / NMA / MAIC / STC / ML-NMR |
+| `cost_effectiveness_model` | Markov / PartSA / decision-tree CEA with PSA, OWSA, CEAC, EVPI, EVPPI; QALY + evLYG support |
+| `budget_impact_model` | ISPOR-compliant BIA with year-by-year output and treatment-displacement modelling |
+| `hta_dossier` | Draft submissions for NICE, EMA, FDA, IQWiG, HAS, and EU JCA — GRADE table uses structured RoB when `rob_results` passed; **inconsistency uses I² when `heterogeneity_per_outcome` passed**; **GRADE upgrading (Guyatt 2011) supported via `upgrading_per_outcome`** |
+| `utility_value_set` | EQ-5D-3L / 5L value-set reference + **baseline-utility-aware** Biz 2026 ICER impact estimator (UK 5L transition) |
+| `validate_links` | HTTP validation of citation URLs before presentation |
 | `project_create` | Initialize a persistent project workspace |
 | `knowledge_search` | Full-text search across a project's raw/ and wiki/ trees |
 | `knowledge_read` | Read any file from a project's knowledge base |
@@ -61,7 +84,7 @@ Add to your MCP configuration:
 
 ### `literature_search`
 
-Searches across 42 sources in parallel. Every call returns a **source selection table** showing which of the 42 sources were used and why — essential for HTA audit trails.
+Searches across 44 sources in parallel. Every call returns a **source selection table** showing which of the 44 sources were used and why — essential for HTA audit trails.
 
 **Example call:**
 ```json
@@ -197,7 +220,7 @@ This single prompt exercises: `project_create` → `literature_search` → `scre
 
 ## Data Sources
 
-**42 sources across 9 categories.** Every `literature_search` call includes a source selection table showing used/not-used status and reason for each.
+**44 sources across 10 categories.** Every `literature_search` call includes a source selection table showing used/not-used status and reason for each.
 
 <details>
 <summary><b>Biomedical & Clinical Trials (5)</b></summary>
@@ -270,9 +293,11 @@ This single prompt exercises: `project_create` → `literature_search` → `scre
 </details>
 
 <details>
-<summary><b>Other (1)</b></summary>
+<summary><b>HEOR Methodology & Utility Reference (3)</b></summary>
 
 - **ISPOR** — HEOR methodology and conference abstracts
+- **OHE (Office of Health Economics)** — EQ-5D value set research and HEOR methodology
+- **EuroQol Group** — EQ-5D instruments, value sets, and registry
 </details>
 
 ---
@@ -293,7 +318,7 @@ DOCX files are saved to `~/.heor-agent/projects/{project}/reports/` (when a proj
 
 Every tool call returns a full audit record:
 
-- **Source selection table** — all 42 sources with used/not-used and reason
+- **Source selection table** — all 44 sources with used/not-used and reason
 - **Sources queried** — queries sent, response counts, status, latency
 - **Inclusions / exclusions** — counts with reasons
 - **Methodology** — PRISMA-style for literature, ISPOR/NICE for economics
@@ -333,10 +358,11 @@ A companion chat interface is available at:
 
 **https://web-michael-ns-projects.vercel.app**
 
-- Chat with Claude Opus 4.6 + all 7 HEOR tools
+- Chat with Claude Sonnet 4.6 + all 17 HEOR tools
 - **BYOK (Bring Your Own Key)** — paste your Anthropic API key in the settings; it stays in your browser's localStorage and is never stored on our servers
-- Markdown rendering with styled tables, tool call cards with live progress timers
-- Example prompts for common HEOR workflows
+- Markdown rendering with styled tables, tool call cards with live progress timers, and theme-aware mermaid network diagrams
+- 12 example prompts covering literature search, CEA, BIA, NMA, ITC feasibility, RoB, EQ-5D 5L, EU JCA dossiers
+- Per-request MCP sessions (no cross-user session bleed)
 
 The web UI calls the hosted MCP server on Railway for tool execution. No setup required — just add your API key and start querying.
 
@@ -353,6 +379,70 @@ Set `MCP_SERVER_URL` to point to your own MCP server instance (default: the publ
 
 ---
 
+## ChatGPT Custom GPT
+
+HEORAgent can also be used as a ChatGPT Custom GPT Action — useful when you (or your team) prefer the ChatGPT interface or have a ChatGPT Plus/Team account but no Anthropic API access.
+
+The web tier exposes an OpenAPI 3.1 adapter at `/api/openapi`, with one POST endpoint per tool at `/api/v1/{tool_name}`. ChatGPT speaks this contract natively.
+
+### What's different from the Anthropic surface
+
+| | Web UI / MCP / Claude Desktop | ChatGPT Custom GPT |
+|---|---|---|
+| Streaming | yes (SSE) | no (45s single response) |
+| `psa_iterations` | up to 10,000 | capped to 1,000 (CEA) / 500 (BIA) |
+| `literature_search.runs` | 1–5 | capped to 1 |
+| `literature_search.max_results` | up to 100 | capped to 30 |
+| Auth model | BYOK Anthropic | optional `X-API-Key` header (server-side `CHATGPT_ADAPTER_TOKEN`) |
+| Surface label in PostHog | `claude_anthropic_web` / `claude_desktop` | `chatgpt_adapter` |
+
+The caps exist because ChatGPT Actions hard-fail at the 45-second response timeout. PSA, multi-run literature search, and full max_results would routinely exceed it. The web UI and MCP clients are unaffected.
+
+### Build a Custom GPT (ChatGPT Plus / Team required)
+
+1. Visit [chatgpt.com/gpts/editor](https://chatgpt.com/gpts/editor) and click **Create**.
+2. **Configure** tab — fill in name (e.g., "HEORAgent"), description, and conversation starters. Paste the system prompt from `web/lib/claude.ts` (or write your own — the tool descriptions are self-documenting).
+3. **Actions** → **Create new action** → **Import from URL** → paste:
+   ```
+   https://web-michael-ns-projects.vercel.app/api/openapi
+   ```
+   ChatGPT auto-imports all 17 endpoints with their schemas.
+4. **Authentication** — choose **None** for the open public endpoint, or **API Key** with the `CHATGPT_ADAPTER_TOKEN` value if you've configured one (recommended for prod).
+5. **Privacy policy URL** — required by GPT Store. Use the web UI's privacy URL or your own.
+6. **Test** in the playground (right pane), then **Publish** → "Anyone with the link" or "GPT Store".
+
+### Securing the adapter for production
+
+By default the `/api/v1/*` endpoint is open. Two layers of protection are recommended for any public-facing GPT:
+
+```bash
+# 1. Token-gate the endpoint
+cd web
+vercel env add CHATGPT_ADAPTER_TOKEN production   # generate a long random token
+# Configure the same token in your Custom GPT under Authentication → API Key
+
+# 2. Built-in rate limit
+# 60 req/min per IP is enforced automatically (lib/rateLimit.ts).
+# For multi-region/high-traffic prod, swap in @upstash/ratelimit + Vercel KV.
+```
+
+### Sample call (manual, no GPT needed)
+
+```bash
+curl -X POST https://web-michael-ns-projects.vercel.app/api/v1/utility_value_set \
+  -H "Content-Type: application/json" \
+  -d '{
+        "action": "estimate_impact",
+        "indication_type": "non_cancer_qol_only",
+        "baseline_utility": 0.85,
+        "base_icer": 30000
+      }'
+```
+
+Returns the Biz 2026 baseline-utility-adjusted ICER projection (the new EQ-5D 5L impact estimator).
+
+---
+
 ## HTTP Transport
 
 The server supports both **stdio** (default, for local MCP clients) and **Streamable HTTP** (for hosted deployment).
@@ -379,7 +469,7 @@ HTTP endpoints:
 git clone https://github.com/neptun2000/heor-agent-mcp
 cd heor-agent-mcp
 npm install
-npm test          # 244 tests across 66 suites
+npm test          # 401 tests across 84 suites
 npm run build     # Compile TypeScript to dist/
 npm run dev       # Run with tsx (no build step)
 ```
@@ -398,10 +488,10 @@ npm run dev       # Run with tsx (no build step)
 ┌────────────────▼──────────────────────────┐
 │  heor-agent-mcp server                    │
 │  ┌──────────────────────────────────────┐ │
-│  │ 7 MCP tools (Zod-validated)          │ │
+│  │ 17 MCP tools (Zod-validated)         │ │
 │  ├──────────────────────────────────────┤ │
 │  │ DirectProvider (default)             │ │
-│  │   ├─ 42 source fetchers              │ │
+│  │   ├─ 44 source fetchers              │ │
 │  │   ├─ Audit builder + PRISMA trail    │ │
 │  │   ├─ Markov / PartSA economic models │ │
 │  │   ├─ Markdown + DOCX formatters      │ │

package/dist/analytics.d.ts

@@ -1,3 +1,12 @@
+/**
+ * Map MCP `clientInfo.name` (set by the calling client during initialize)
+ * to a canonical surface label so PostHog can distinguish events from
+ * Claude Desktop, the Vercel web UI, the ChatGPT Custom GPT adapter, etc.
+ *
+ * Returns "direct_mcp" for unknown / npx / third-party clients.
+ */
+export type ClientSurface = "claude_anthropic_web" | "chatgpt_adapter" | "claude_desktop" | "smithery" | "glama" | "pulsemcp" | "direct_mcp";
+export declare function inferSurface(clientName: string | undefined): ClientSurface;
 export declare function trackEvent(event: string, properties?: Record<string, unknown>, sessionId?: string): void;
 export declare function trackToolCall(toolName: string, durationMs: number, status: "ok" | "error", sessionId?: string, properties?: Record<string, unknown>): void;
 export declare function trackSession(event: "session_start" | "session_end", sessionId: string, properties?: Record<string, unknown>): void;

package/dist/analytics.d.ts.map

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package/dist/analytics.js

@@ -1,4 +1,24 @@
 import { PostHog } from "posthog-node";
+export function inferSurface(clientName) {
+    if (!clientName)
+        return "direct_mcp";
+    const n = clientName.toLowerCase();
+    if (n.startsWith("heor-web-ui"))
+        return "claude_anthropic_web";
+    if (n.startsWith("chatgpt-adapter"))
+        return "chatgpt_adapter";
+    if (n === "claude" ||
+        n.startsWith("claude-ai") ||
+        n.startsWith("claude-desktop"))
+        return "claude_desktop";
+    if (n.startsWith("smithery"))
+        return "smithery";
+    if (n.startsWith("glama"))
+        return "glama";
+    if (n.startsWith("pulsemcp"))
+        return "pulsemcp";
+    return "direct_mcp";
+}
 let client = null;
 function getClient() {
     if (client)

package/dist/analytics.js.map

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package/dist/formatters/comparisonMarkdown.d.ts.map

@@ -1 +1 @@
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package/dist/formatters/comparisonMarkdown.js

@@ -47,6 +47,22 @@ export function comparisonToMarkdown(result) {
             lines.push(`| ${e.intervention} vs ${e.comparator} | ${est} | ${ci} | ${p} | ${via} | ${method} |`);
         }
         lines.push("");
+        // Bucher consistency check (when direct h2h evidence available)
+        const conflicts = estimates.filter((e) => e.consistency_check && e.consistency_check.severity !== "none");
+        if (conflicts.length > 0) {
+            lines.push("**Bucher consistency check (direct vs indirect):**");
+            lines.push("");
+            for (const e of conflicts) {
+                const c = e.consistency_check;
+                const icon = c.severity === "substantial"
+                    ? "🚨"
+                    : c.severity === "moderate"
+                        ? "⚠️"
+                        : "ℹ️";
+                lines.push(`${icon} **${e.intervention} vs ${e.comparator}** (severity: ${c.severity}): ${c.rationale}`);
+            }
+            lines.push("");
+        }
     }
     // Heterogeneity statistics (I², Cochran Q)
     if (result.heterogeneity && result.heterogeneity.length > 0) {

package/dist/formatters/comparisonMarkdown.js.map

@@ -1 +1 @@
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package/dist/grade/eq5dImpact.d.ts

@@ -0,0 +1,43 @@
+/**
+ * Baseline-utility-aware EQ-5D 3L→5L impact estimator.
+ *
+ * Biz, Hernández Alava, Wailoo (2026) report category-level medians for the
+ * UK 3L→5L value-set transition. The new 5L value set has compressed utilities
+ * in mild–moderate health states relative to 3L (DSU mapping), which means
+ * the ICER impact of the transition depends strongly on the patient cohort's
+ * baseline utility:
+ *
+ *   - non_cancer_qol_only: utility loss is concentrated in the 0.6–0.9 zone.
+ *     Drugs treating MILD chronic conditions (baseline ~0.85, e.g., mild
+ *     plaque psoriasis) see the biggest ICER increase. SEVERE versions of
+ *     these conditions (baseline ~0.45, e.g., severe HS Hurley III) see
+ *     less impact because patients spend more time in low-utility states
+ *     where 5L compression is less severe.
+ *
+ *   - cancer_life_extending: improvement is concentrated in severe states
+ *     (5L assigns higher utility to the worst states than DSU mapping does),
+ *     so a drug treating advanced/metastatic disease (baseline ~0.4) sees
+ *     a bigger ICER decrease than one treating early-stage disease.
+ *
+ *   - non_cancer_life_extending: Biz report mixed direction (7/11 decreased,
+ *     4/11 increased). Modulation is not defensible without the underlying
+ *     state-by-state utility differences, so we return median + warning.
+ *
+ * The modulation factor is deliberately conservative — labelled as an
+ * extrapolation, not a finding from the paper. Users are advised to re-run
+ * their economic model with both value sets for an exact estimate.
+ */
+import type { IndicationType } from "../data/eq5dValueSets.js";
+export interface BaselineAdjustedImpact {
+    indication_type: IndicationType;
+    icer_change_pct: {
+        point: number;
+        lower: number;
+        upper: number;
+    };
+    is_baseline_adjusted: boolean;
+    baseline_utility?: number;
+    rationale: string;
+}
+export declare function estimateBaselineAdjustedImpact(indication: IndicationType, baseline_utility: number | undefined): BaselineAdjustedImpact;
+//# sourceMappingURL=eq5dImpact.d.ts.map

package/dist/grade/eq5dImpact.d.ts.map

@@ -0,0 +1 @@
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package/dist/grade/eq5dImpact.js

@@ -0,0 +1,132 @@
+/**
+ * Baseline-utility-aware EQ-5D 3L→5L impact estimator.
+ *
+ * Biz, Hernández Alava, Wailoo (2026) report category-level medians for the
+ * UK 3L→5L value-set transition. The new 5L value set has compressed utilities
+ * in mild–moderate health states relative to 3L (DSU mapping), which means
+ * the ICER impact of the transition depends strongly on the patient cohort's
+ * baseline utility:
+ *
+ *   - non_cancer_qol_only: utility loss is concentrated in the 0.6–0.9 zone.
+ *     Drugs treating MILD chronic conditions (baseline ~0.85, e.g., mild
+ *     plaque psoriasis) see the biggest ICER increase. SEVERE versions of
+ *     these conditions (baseline ~0.45, e.g., severe HS Hurley III) see
+ *     less impact because patients spend more time in low-utility states
+ *     where 5L compression is less severe.
+ *
+ *   - cancer_life_extending: improvement is concentrated in severe states
+ *     (5L assigns higher utility to the worst states than DSU mapping does),
+ *     so a drug treating advanced/metastatic disease (baseline ~0.4) sees
+ *     a bigger ICER decrease than one treating early-stage disease.
+ *
+ *   - non_cancer_life_extending: Biz report mixed direction (7/11 decreased,
+ *     4/11 increased). Modulation is not defensible without the underlying
+ *     state-by-state utility differences, so we return median + warning.
+ *
+ * The modulation factor is deliberately conservative — labelled as an
+ * extrapolation, not a finding from the paper. Users are advised to re-run
+ * their economic model with both value sets for an exact estimate.
+ */
+import { getImpactEstimate } from "../data/eq5dValueSets.js";
+/**
+ * Modulate the published median by baseline utility.
+ *
+ * Reference baselines (calibrated so multiplier=1.0 ≈ published median):
+ *   - non_cancer_qol_only:    ref_baseline = 0.65 (typical of NICE TA dataset)
+ *   - cancer_life_extending:  ref_baseline = 0.55
+ *
+ * Linear scaling within plausible bounds (×0.4 to ×1.7) — wider than the
+ * IQR of the published distribution to acknowledge extrapolation uncertainty.
+ */
+function multiplierForQolOnly(baseline) {
+    const ref = 0.65;
+    const slope = 1.5; // each +0.1 baseline → +15% multiplier
+    const raw = 1 + slope * (baseline - ref);
+    return Math.min(1.7, Math.max(0.4, raw));
+}
+function multiplierForCancer(baseline) {
+    // For cancer life-extending, a LOWER baseline means BIGGER impact (more negative %).
+    // ref=0.55 → multiplier=1.0
+    const ref = 0.55;
+    const slope = -2.0; // each +0.1 baseline → -20% multiplier (less impact)
+    const raw = 1 + slope * (baseline - ref);
+    return Math.min(1.7, Math.max(0.4, raw));
+}
+export function estimateBaselineAdjustedImpact(indication, baseline_utility) {
+    if (baseline_utility !== undefined) {
+        if (baseline_utility < 0 || baseline_utility > 1) {
+            throw new Error(`baseline_utility must be in [0, 1]; got ${baseline_utility}`);
+        }
+    }
+    const published = getImpactEstimate(indication);
+    // Guard: indication categories without a published median (future entries
+    // added before data is populated) must not silently return a degenerate
+    // {0, 0, 0} range. Return is_baseline_adjusted=false with an explicit
+    // "no estimate available" rationale so callers can branch.
+    if (!published) {
+        return {
+            indication_type: indication,
+            icer_change_pct: { point: 0, lower: 0, upper: 0 },
+            is_baseline_adjusted: false,
+            baseline_utility,
+            rationale: `No published impact estimate for ${indication} — this category has no Biz 2026 entry yet. Re-run your model under both value sets for a direct estimate.`,
+        };
+    }
+    const median = published.median_icer_change_pct;
+    // Range for unmodulated estimate (±25% of median to reflect inter-study spread)
+    const baseRange = {
+        point: median,
+        lower: median - Math.abs(median) * 0.25,
+        upper: median + Math.abs(median) * 0.25,
+    };
+    if (baseline_utility === undefined) {
+        return {
+            indication_type: indication,
+            icer_change_pct: baseRange,
+            is_baseline_adjusted: false,
+            rationale: `Published median for ${indication} (Biz et al. 2026, n=${published.examples?.length ?? 0} indication examples).`,
+        };
+    }
+    if (indication === "non_cancer_life_extending") {
+        return {
+            indication_type: indication,
+            icer_change_pct: baseRange,
+            is_baseline_adjusted: false,
+            baseline_utility,
+            rationale: "Mixed/heterogeneous direction in Biz 2026 (7/11 decreased, 4/11 increased) — cannot reliably modulate by baseline utility. Re-run the model with both value sets for an exact estimate.",
+        };
+    }
+    let multiplier;
+    let directionalNote;
+    if (indication === "non_cancer_qol_only") {
+        multiplier = multiplierForQolOnly(baseline_utility);
+        directionalNote =
+            baseline_utility > 0.75
+                ? `MILD baseline utility (${baseline_utility.toFixed(2)}) → 5L compression in mild-moderate states hits this cohort harder; expect larger ICER increase than category median.`
+                : baseline_utility < 0.55
+                    ? `SEVERE baseline utility (${baseline_utility.toFixed(2)}) → patients spend more time in low-utility states where 5L compression is less severe; expect smaller ICER increase than category median.`
+                    : `Baseline utility (${baseline_utility.toFixed(2)}) near typical NICE TA dataset average — expect impact close to published median.`;
+    }
+    else {
+        multiplier = multiplierForCancer(baseline_utility);
+        directionalNote =
+            baseline_utility < 0.45
+                ? `Advanced/metastatic disease (baseline=${baseline_utility.toFixed(2)}) — 5L assigns higher utility to severe states than DSU mapping; expect larger ICER decrease than median.`
+                : baseline_utility > 0.65
+                    ? `Earlier-stage disease (baseline=${baseline_utility.toFixed(2)}) — patients spend less time in severe states; expect smaller ICER decrease than median.`
+                    : `Baseline utility (${baseline_utility.toFixed(2)}) near typical advanced-cancer dataset average — expect impact close to published median.`;
+    }
+    const adjustedPoint = median * multiplier;
+    return {
+        indication_type: indication,
+        icer_change_pct: {
+            point: adjustedPoint,
+            lower: adjustedPoint - Math.abs(adjustedPoint) * 0.3,
+            upper: adjustedPoint + Math.abs(adjustedPoint) * 0.3,
+        },
+        is_baseline_adjusted: true,
+        baseline_utility,
+        rationale: `${directionalNote} This is an EXTRAPOLATION beyond Biz 2026 (which reports only category-level medians) — not a direct finding. Approximation: multiplier ${multiplier.toFixed(2)}× applied to published median ${median}%. Validate by re-running your model under both value sets.`,
+    };
+}
+//# sourceMappingURL=eq5dImpact.js.map

package/dist/grade/eq5dImpact.js.map

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package/dist/grade/inconsistency.d.ts

@@ -0,0 +1,29 @@
+/**
+ * GRADE Inconsistency assessment.
+ *
+ * Per Cochrane Handbook Ch. 10.10 / GRADE Handbook 5.1, inconsistency reflects
+ * heterogeneity of effect estimates across studies — NOT the number of studies.
+ *
+ * Single-study comparisons cannot be assessed for inconsistency; they are
+ * downgraded for imprecision instead. This function returns "not_assessable"
+ * for k=1, mapping I² bands to GRADE inconsistency levels otherwise.
+ *
+ * I² interpretation bands (Cochrane):
+ *   0–40%   might not be important
+ *   30–60%  moderate heterogeneity
+ *   50–90%  substantial heterogeneity
+ *   75–100% considerable heterogeneity
+ *
+ * GRADE downgrade mapping:
+ *   <50%   Low (no downgrade)
+ *   50–75% Moderate (consider 1-step downgrade — "Serious")
+ *   >75%   Serious (1-step downgrade — "Very Serious" if ≥90%)
+ */
+export type GradeInconsistency = "not_assessable" | "Low" | "Moderate" | "Serious" | "Very Serious";
+export interface InconsistencyAssessment {
+    level: GradeInconsistency;
+    downgrade_steps: 0 | 1 | 2;
+    rationale: string;
+}
+export declare function assessInconsistency(n_studies: number, i_squared_pct: number | null): InconsistencyAssessment;
+//# sourceMappingURL=inconsistency.d.ts.map

package/dist/grade/inconsistency.d.ts.map

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package/dist/grade/inconsistency.js

@@ -0,0 +1,75 @@
+/**
+ * GRADE Inconsistency assessment.
+ *
+ * Per Cochrane Handbook Ch. 10.10 / GRADE Handbook 5.1, inconsistency reflects
+ * heterogeneity of effect estimates across studies — NOT the number of studies.
+ *
+ * Single-study comparisons cannot be assessed for inconsistency; they are
+ * downgraded for imprecision instead. This function returns "not_assessable"
+ * for k=1, mapping I² bands to GRADE inconsistency levels otherwise.
+ *
+ * I² interpretation bands (Cochrane):
+ *   0–40%   might not be important
+ *   30–60%  moderate heterogeneity
+ *   50–90%  substantial heterogeneity
+ *   75–100% considerable heterogeneity
+ *
+ * GRADE downgrade mapping:
+ *   <50%   Low (no downgrade)
+ *   50–75% Moderate (consider 1-step downgrade — "Serious")
+ *   >75%   Serious (1-step downgrade — "Very Serious" if ≥90%)
+ */
+export function assessInconsistency(n_studies, i_squared_pct) {
+    if (n_studies <= 0) {
+        return {
+            level: "not_assessable",
+            downgrade_steps: 0,
+            rationale: "No studies — domain not assessable",
+        };
+    }
+    if (n_studies === 1) {
+        return {
+            level: "not_assessable",
+            downgrade_steps: 0,
+            rationale: "Single study — inconsistency not assessable (consider imprecision instead)",
+        };
+    }
+    if (i_squared_pct == null) {
+        // Was: level="Moderate", downgrade_steps=0 — internally inconsistent
+        // (every other Moderate path uses 1 step). Returning not_assessable
+        // with 0 downgrade forces an explicit manual decision instead of
+        // silently inflating GRADE certainty.
+        return {
+            level: "not_assessable",
+            downgrade_steps: 0,
+            rationale: "Multiple studies but I² not computed — manual heterogeneity review recommended",
+        };
+    }
+    if (i_squared_pct >= 90) {
+        return {
+            level: "Very Serious",
+            downgrade_steps: 2,
+            rationale: `I²=${i_squared_pct.toFixed(0)}% (considerable heterogeneity, ≥90%)`,
+        };
+    }
+    if (i_squared_pct >= 75) {
+        return {
+            level: "Serious",
+            downgrade_steps: 1,
+            rationale: `I²=${i_squared_pct.toFixed(0)}% (considerable heterogeneity, 75–89%)`,
+        };
+    }
+    if (i_squared_pct >= 50) {
+        return {
+            level: "Moderate",
+            downgrade_steps: 1,
+            rationale: `I²=${i_squared_pct.toFixed(0)}% (substantial heterogeneity, 50–74%)`,
+        };
+    }
+    return {
+        level: "Low",
+        downgrade_steps: 0,
+        rationale: `I²=${i_squared_pct.toFixed(0)}% (low heterogeneity, <50%)`,
+    };
+}
+//# sourceMappingURL=inconsistency.js.map

package/dist/grade/inconsistency.js.map

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package/dist/grade/upgrading.d.ts

@@ -0,0 +1,32 @@
+/**
+ * GRADE Upgrading assessment for observational evidence (Guyatt 2011).
+ *
+ * GRADE allows upgrading observational studies that start at "Low" certainty
+ * for three specific reasons:
+ *   1. Large magnitude of effect (RR < 0.5 or > 2.0 → +1; RR < 0.2 or > 5.0 → +2)
+ *   2. Dose-response gradient
+ *   3. Plausible confounding/bias would reduce the observed effect (i.e.,
+ *      bias is biasing toward null, so the true effect is likely larger)
+ *
+ * Total upgrade is capped at +2 steps. Upgrading does NOT apply when the
+ * starting certainty is High (RCTs) — RCTs cannot be upgraded above High.
+ *
+ * Reference: Guyatt GH et al. GRADE guidelines: 9. Rating up the quality
+ * of evidence. J Clin Epidemiol. 2011;64(12):1311-1316.
+ */
+export interface UpgradingInput {
+    /** Starting certainty before downgrades — "High" for RCTs, "Low" for observational. */
+    start_certainty: "High" | "Low";
+    /** Magnitude of effect (effect size relative to control). */
+    large_effect?: "none" | "large" | "very_large";
+    /** Documented dose-response gradient. */
+    dose_response?: boolean;
+    /** Plausible residual confounding would bias the effect toward null. */
+    plausible_confounding_toward_null?: boolean;
+}
+export interface UpgradingAssessment {
+    upgrade_steps: 0 | 1 | 2;
+    rationale: string;
+}
+export declare function assessUpgrading(input: UpgradingInput): UpgradingAssessment;
+//# sourceMappingURL=upgrading.d.ts.map