Methodology & Editorial Standards

How the American Society of Hirudotherapy evaluates evidence, manages conflicts of interest, and maintains scientific rigor across 134+ pages of clinical and scientific content

Last Updated: May 27, 2026Reviewed by: Andrei Dokukin, MD

Editorial & evidence methodologyReference framework

Last updated: June 18, 2026

Why Methodology Transparency Matters

Medical-society websites are read by clinicians making patient-care decisions, patients evaluating treatment options, journalists writing health stories, researchers seeking grants, and regulators conducting oversight. Each reader deserves to know HOW our content is built — what evidence we cite, how we weight it, who reviews it, how we handle disagreement, and how we correct errors when we make them. This page documents the editorial methodology that governs everything published on hirudotherapysociety.org.

Our methodology is modeled on the highest standards in medical publishing — Cochrane's PRISMA framework, GRADE evidence appraisal, ICMJE authorship criteria, IRS Form 1023 Sample Conflict-of-Interest Policy, and CMS Open Payments transparency. Where our practice differs from these references, we explain why.

Important: ASH is a 501(c)(3) non-profit medical professional society — not a regulatory agency. Our editorial methodology does not substitute for FDA, EMA, or other government regulatory authority decisions. Where ASH's evidence appraisal differs from a government regulator's, we cite both positions and let the reader evaluate.

Seven methodology sections:

Evidence Framework: GRADE + ASH Tier System

How we classify the strength of evidence behind every clinical claim

ASH uses two complementary evidence-classification systems, applied to every clinical claim on every page.

GRADE Framework (Standard Medical Evidence Appraisal)

The Grading of Recommendations Assessment, Development and Evaluation (GRADE) framework is the international standard for evaluating clinical evidence, used by WHO, NICE, Cochrane, and ACC/AHA. GRADE rates each clinical question's evidence quality from High (further research very unlikely to change the estimate) through Moderate, Low, to Very Low (estimate is very uncertain). For hirudotherapy: knee osteoarthritis evidence is GRADE Moderate (6 RCTs, n=400+, Cohen's d=0.82); microsurgical flap salvage is GRADE Low-to-Moderate (large case series, no RCT possible due to ethical constraints); off-label indications are typically GRADE Low or Very Low.

ASH Tier System (Regulatory Status)

Beyond GRADE, ASH applies a three-tier system that maps every indication to its U.S. regulatory status: Tier A (FDA-Cleared) — venous congestion in microsurgical flaps, grafts, and replants under K040187/K132958/K140907. Tier B (Clinical Evidence) — published RCTs or systematic reviews supporting use (e.g., knee OA, lateral epicondylitis), but not part of FDA-cleared indications. Tier C (Investigational) — documented historical or contemporary use without published RCT evidence (e.g., migraine, hypertension, neuropathy).

Combined Application

Every clinical page on this site identifies BOTH the GRADE rating AND the ASH Tier. A patient or clinician seeing 'GRADE Moderate · Tier B' immediately knows: evidence quality is moderate, but use is off-label. 'GRADE Low-Moderate · Tier A' means lower evidence quality but FDA-cleared indication. The combination prevents confusion that arises when a treatment has either strong evidence but no regulatory approval OR regulatory approval but limited evidence.

Citation Standards

How every claim links to primary evidence

Every quantitative claim or evidence-based assertion on this site links to identifiable primary literature. We use four citation tiers.

Tier 1: Peer-Reviewed PMID Citations

For clinical evidence — RCTs, systematic reviews, meta-analyses — we cite by author + year + journal + PMID (e.g., 'Whitaker et al., 2012, Microsurgery, PMID 22407551'). The PMID resolves to the canonical PubMed record. Where the article has an open-access version, we link to PubMed Central (PMC). Where DOI is the more stable identifier, we provide both.

Tier 2: FDA Regulatory Documents

For regulatory claims, we cite FDA AccessData directly — 510(k) clearance letters, summary of safety and effectiveness data (SSED), and labeling. Example: 'K040187 (Ricarimpex SAS, FDA-cleared June 21, 2004) lists venous congestion in flaps/grafts/replants as the cleared indication.' The FDA AccessData record is the source of truth.

Tier 3: Professional Society Guidelines

For practice standards, we cite specialty-society guidelines (ACC/AHA, ACR, ASRM, etc.) by year and full document title. Example: 'ACC/AHA 2021 PCI Guidelines list bivalirudin as Class I recommendation in selected patient populations.'

Tier 4: Historical and Trade Sources

For pre-1990 literature (Haycraft 1884, Jacoby 1902, Termier 1922, Markwardt 1957), we cite original journal + year. Where electronic indexing is incomplete, we identify the source library archive. For pharmaceutical company history (lepirudin/Refludan, bivalirudin/Angiomax), we cite manufacturer press releases or SEC filings.

Conflict of Interest Policy

How we identify and manage financial and non-financial conflicts

ASH maintains a Conflict of Interest (COI) policy aligned with IRS Form 1023 Sample COI Policy, ICMJE authorship requirements, and CMS Open Payments framework.

Disclosure Requirements

Every Board member, advisor, content contributor, and staff member submits a written annual disclosure covering: (a) financial relationships with pharmaceutical, device, or biotech companies (any equity, royalty, consulting, speaker, advisory board, or grant support); (b) non-financial relationships including unpaid advisory roles, family member employment, and intellectual-property positions; (c) relevant patent filings or pending patents. Disclosures cover the prior 24 months.

Recusal Standards

Any disclosed conflict exceeding $5,000/year in financial value or any equity position triggers recusal from related editorial decisions. The Board chair reviews disclosures annually and identifies content areas where recusal applies. Recused individuals do not vote on, edit, or approve content where the conflict applies.

Public Availability

Aggregate disclosure data (categories and totals, not individual amounts) is published in the Annual Report. Individual disclosures are available upon request for legitimate journalistic, research, or regulatory inquiries. Disclosure access requests are logged and answered within 30 days.

Current State

As of 2026, ASH's founding officers have no material financial relationships with leech aquaculture suppliers (Ricarimpex, Biopharm UK, Carolina Biological), with pharmaceutical companies marketing leech-derived drugs (Bayer/lepirudin, Spectrum/bivalirudin, Sanofi/desirudin, Boehringer Ingelheim/dabigatran), or with medical device manufacturers in adjacent spaces. The Board chair maintains primary-care medical practice with no leech-therapy revenue; the Director of Operations leads aquaculture-research efforts that may eventually create a separate commercial entity (disclosed proactively).

Peer Review & Quality Assurance

Multi-layer review process before any content is published

Every page on this site passes through a four-layer review process before publication.

Layer 1: Draft + Citation Pull

Content is drafted by a topic specialist (typically the Clinical Director for clinical content; the Director of Operations for organizational content). Every quantitative claim is annotated with its primary-source citation at draft stage. Drafts are not advanced without complete citations.

Layer 2: Editorial Review

Editorial review checks: (a) every cited PMID resolves to the asserted claim, (b) GRADE rating + Tier classification are appropriate, (c) regulatory framing distinguishes FDA-cleared from off-label, (d) patient-facing language meets readability standards (Flesch-Kincaid grade 8–10 target), (e) no commercial endorsements implicit in tone.

Layer 3: Clinical Accuracy Review

Clinical content is reviewed by the Clinical Director (Andrei Dokukin, MD) for medical accuracy, appropriate dosing/protocols, safety framing, and consistency with current standard-of-care literature. Where clinical judgment is required, the reviewer cites the source of that judgment.

Layer 4: Regulatory Review

Final regulatory review confirms: FDA-cleared status correctly stated; off-label content includes appropriate disclaimers; HIPAA requirements met for any patient-stories content; intellectual property attribution complete; no misleading or unverifiable claims.

Re-Review Cadence

Every published page is re-reviewed annually for accuracy and currency. Major regulatory changes (e.g., FDA jurisdiction transfer December 30, 2024) trigger immediate review of all affected pages. The Correction Log (linked below) lists every substantive change with date, scope, and rationale.

Error Correction Protocol

How we handle errors transparently when we make them

ASH maintains a public Correction Log documenting every substantive content change. This is the most-important transparency commitment of a medical-society website.

What Triggers a Correction Log Entry

Any change to a clinical fact, citation, regulatory claim, or quantitative value triggers a Correction Log entry. Typo corrections, formatting changes, and stylistic edits do not. The threshold is: would a reader's understanding of the topic change after the correction?

Correction Log Format

Every entry includes: date of correction, type (regulatory/clinical/citation/safety/scientific), scope (which pages affected), what was changed (old text → new text in summary form), and rationale (why the change was needed). The log is append-only — corrections are never deleted, even when superseded by later corrections.

Reporting Errors to ASH

Readers who identify errors can report them via the contact form or email. We commit to acknowledging error reports within 48 hours, assessing within 2 weeks, and either correcting or providing rationale for non-correction within 4 weeks. Significant errors triggering correction are credited to the reporter (anonymously by default; named if reporter consents).

Evidence Over Anecdote

Our editorial commitment to data-driven medicine

ASH's founding mission is the restoration of evidence-based medicinal leech therapy to U.S. clinical practice. The phrase 'evidence over anecdote' is not slogan — it is operational policy applied at every editorial decision.

What This Means in Practice

When historical Russian-tradition literature describes hirudotherapy outcomes in conditions where no RCT exists (e.g., migraine, hypertension, neuropathy), we cite that literature as documentary evidence of historical use — NOT as evidence of efficacy. The distinction is made explicit on every relevant page. Where modern peer-reviewed RCTs exist (knee OA, lateral epicondylitis, microvascular salvage), we cite those as efficacy evidence.

Patient Stories

Patient stories on this site are framed as composite cases derived from documented clinical patterns — illustrative, not representational of named individuals. This protects patient privacy (HIPAA 45 CFR 164.514(b)) while providing accurate clinical context. Every patient story includes explicit composite framing. Off-label stories include FDA off-label disclosure callouts.

Off-Label Use Disclosure

Every off-label clinical application is explicitly marked. Off-label means: the indication described is not part of the FDA-cleared indications-for-use language. Off-label use is legal in the U.S. and is common across medicine (estimated 21% of prescriptions are off-label per JAMA Internal Medicine 2008), but transparency is essential for informed decision-making.

Data & Source Transparency

How readers can verify any claim on this site

Every page links to primary sources. Every database we maintain is publicly accessible. Every editorial decision pathway is documented.

Open Citation Network

The Research Library indexes 269 peer-reviewed publications with full citations, PMID links, and (where available) DOI and full-text URLs. The Trusted Sources page lists 71 external authoritative sources with brief descriptions and relevance notes. The Compound Reference catalogs 440+ identified salivary proteins with molecular weight, target, and functional category.

Sitemap & Coverage

The sitemap at /sitemap.xml lists every page. Internal coverage tracking (lib/sitemap-tree.json) records every locale's coverage status for every page — visible to internal admin but reflected in the Annual Report's content metrics (134+ evidence-based pages, growing).

Translation Transparency

Content is published in English, Russian, Spanish, and German. Translation accuracy is verified against the English canonical. Where translation disagrees with the canonical (e.g., locale-specific medical-term variations), the discrepancy is noted in the editorial review. The DACH (Germany/Austria/Switzerland), Russian-speaking, and Hispanic-American communities have distinct medical traditions; we accommodate that without diluting evidence standards.

Editorial Principles in Summary

Evidence Over Anecdote

Every clinical claim is anchored to primary literature. Historical and traditional uses are cited as documentary evidence of practice, not efficacy.

Regulatory Clarity

FDA-cleared, off-label, and investigational uses are distinctly marked on every page. Readers always know the regulatory context.

Transparency by Default

Correction logs, COI disclosures, methodology documents, and source links are public. Where we don't yet know something, we say so.

Patient Privacy & Dignity

Patient stories use composite framing per HIPAA 45 CFR 164.514(b). No re-identifiable patient data. No imagery without explicit written consent.

No Commercial Bias

ASH receives no compensation from leech aquaculture suppliers, pharmaceutical companies, or device manufacturers. Operations are funded by tax-deductible donations under IRS 501(c)(3).

Continuous Improvement

Pages are reviewed annually. Methodology evolves with the field. Reader-reported errors are acknowledged within 48 hours and resolved within 4 weeks.

How ASH's Methodology Compares to Industry Standards

ASH's editorial methodology is benchmarked against the most rigorous standards in medical publishing:

Standard	What It Requires	ASH Implementation
Cochrane Collaboration	PRISMA-compliant systematic reviews; pre-registered protocols on PROSPERO	ASH cites Cochrane reviews directly; pre-registers systematic-review work where applicable
GRADE Working Group	Evidence quality rating: High / Moderate / Low / Very Low	Applied to every clinical claim on every page, alongside ASH Tier system
ICMJE (International Committee of Medical Journal Editors)	Authorship criteria, COI disclosure, ethics standards	Applied to ASH content contribution; authorship credited for substantive contributions
IRS Form 1023 (501(c)(3) Sample COI Policy)	Annual written disclosure; recusal from conflicted decisions; public availability	ASH COI policy adapted from this template, applied to Board + advisors + contributors
CMS Open Payments (Sunshine Act)	Public reporting of physician–industry financial relationships	ASH does not have CMS Open Payments reporting obligations (not directly receiving CMS-reportable transfers), but voluntarily applies analogous transparency principles
HIPAA 45 CFR 164.514(b)	Safe Harbor de-identification for patient data	Patient stories use composite framing meeting Safe Harbor + clear composite disclosure

Engaging with ASH Methodology

Readers, clinicians, journalists, researchers, and regulators interested in ASH's methodology or who wish to report errors, request COI disclosures, or propose methodology improvements: