{
  "name": "The Shape of Harm Research Framework",
  "scientific_title": "A scenario-based comparative risk and decision-analysis framework for psychoactive substances",
  "version": "0.7",
  "date": "2026-07-23",
  "status": "external_review_launch_package_prepared_pending_team_registration_and_search",
  "identity": {
    "primary": "scenario_based_comparative_risk_model",
    "optional": "multi_criteria_decision_analysis_layer",
    "not": [
      "psychometric_reflective_scale",
      "context_free_drug_badness_measure",
      "individual_clinical_prediction_tool"
    ]
  },
  "views": [
    {
      "id": "one_episode",
      "denominator": "100000 defined episodes",
      "default_aggregate": false
    },
    {
      "id": "regular_use",
      "denominator": "1000 user-years or outcome-specific conditional denominator",
      "default_aggregate": false
    },
    {
      "id": "population_burden",
      "denominator": "100000 residents per year and total burden",
      "default_aggregate": false
    }
  ],
  "required_scenario_fields": [
    "substance",
    "formulation",
    "supply_source",
    "dose_or_intensity",
    "route",
    "frequency",
    "duration",
    "co_use",
    "setting",
    "supervision",
    "user_history_or_vulnerability",
    "population",
    "geography",
    "calendar_period",
    "comparator",
    "outcome_window"
  ],
  "analysis_principles": [
    "natural_units_before_0_to_100_transformation",
    "non_overlapping_outcomes",
    "missing_is_not_zero",
    "direct_estimates_distinguished_from_model_predictions",
    "evidence_estimates_separate_from_value_weights",
    "swing_weights_only_after_value_functions_and_scale_anchors",
    "parameter_heterogeneity_bias_indirectness_and_structural_uncertainty_explicit",
    "no_universal_overall_rank_by_default"
  ],
  "validation_targets": [
    "content_validity",
    "review_process_reliability",
    "construct_behavior_hypotheses",
    "external_holdout_validation",
    "uncertainty_calibration",
    "temporal_and_geographic_transportability",
    "decision_robustness",
    "independent_replication"
  ],
  "prohibited_shortcuts": [
    "single_author_unblinded_scoring_as_primary_evidence",
    "cronbach_alpha_as_validation_of_distinct_harm_domains",
    "fixed_uncertainty_width_by_evidence_grade",
    "mixing_per_user_and_population_burden_in_one_axis",
    "combining_use_disorder_physical_dependence_and_withdrawal_as_one_construct",
    "publishing_rank_before_estimand_and_denominator_are_locked"
  ],
  "files": {
    "protocol": "RESEARCH_PROTOCOL_V0.2.md",
    "validation": "VALIDATION_PLAN.md",
    "scenarios": "scenario-registry.csv",
    "outcomes": "outcome-dictionary.csv",
    "extraction": "evidence-extraction-template.csv",
    "research_page": "research.html",
    "estimand_protocol": "PILOT_ESTIMANDS_V0.2.md",
    "estimand_registry": "estimand-registry.csv",
    "estimand_json": "estimands-v0.2.json",
    "content_validity_form": "estimand-content-validity-form.csv",
    "estimand_page": "estimands.html",
    "feasibility_register": "estimand-feasibility-register.csv",
    "estimand_implementation_audit": "ESTIMAND_IMPLEMENTATION_AUDIT.md",
    "certainty_page": "certainty.html",
    "certainty_analysis": "CERTAINTY_AND_INFORMATION_ANALYSIS_V0.1.md",
    "grade_profile": "grade-evidence-profile.csv",
    "sensitivity_analysis": "rare-event-sensitivity.csv",
    "information_targets": "information-size-targets.csv",
    "review_readiness": "review-readiness-checklist.csv",
    "replication_page": "replication.html",
    "independent_replication_protocol": "PSILOCYBIN_INDEPENDENT_REPLICATION_PROTOCOL_V0.2.md",
    "protocol_lock": "protocol-lock.json",
    "launch": "launch.html",
    "launch_plan": "EXTERNAL_REVIEW_LAUNCH_PLAN_V0.7.md"
  },
  "estimand_framework": {
    "basis": "ICH E9(R1) adapted for observational and public-health risk estimation",
    "required_attributes": [
      "target_population",
      "exposure_strategy",
      "comparator_strategy",
      "outcome_set",
      "intercurrent_events_strategy",
      "summary_measure",
      "time_horizon",
      "geography",
      "calendar_period",
      "comparability_class",
      "identification_assumptions"
    ],
    "change_control": "material changes create a new estimand version and dated amendment",
    "cross_scenario_rule": "no ranking across incompatible comparability classes"
  },
  "pilot_estimands": [
    {
      "id": "EST-AE-ALC-001",
      "scenario_id": "PILOT_A_ALC_60G_COMMUNITY",
      "status": "provisional_frozen_pending_content_review",
      "feasibility": "medium-low"
    },
    {
      "id": "EST-RU-TOB-001",
      "scenario_id": "PILOT_B_TOB_CONTINUE_VS_CEASE",
      "status": "provisional_frozen_pending_content_review",
      "feasibility": "medium-high"
    },
    {
      "id": "EST-AE-OPI-001",
      "scenario_id": "PILOT_C_OPIOID_UNVERIFIED_INTRNASAL",
      "status": "provisional_frozen_pending_content_review",
      "feasibility": "low"
    },
    {
      "id": "EST-AE-PSI-001",
      "scenario_id": "PILOT_D_PSI_25MG_CLINICAL",
      "status": "provisional_frozen_pending_content_review",
      "feasibility": "high within controlled setting"
    }
  ],
  "feasibility_stage": {
    "status": "author_screen_complete_not_independent_validation",
    "page": "feasibility.html",
    "decisions": {
      "EST-AE-ALC-001": "blocked_pending_denominator_study",
      "EST-RU-TOB-001": "revise_or_data_fusion_before_estimation",
      "EST-AE-OPI-001": "blocked_pending_episode_denominator_and_linkage",
      "EST-AE-PSI-001": "proceed_to_systematic_evidence_map"
    },
    "first_review_protocol": "PSILOCYBIN_SAFETY_REVIEW_PROTOCOL_V0.1.md"
  },
  "evidence_stage": {
    "estimand_id": "EST-AE-PSI-001",
    "direct_studies": 2,
    "releasable_outcomes": 1,
    "blocked_outcomes": 3,
    "independent_review_complete": false,
    "certainty_assessment": "very_low_provisional",
    "certainty_independently_adjudicated": false,
    "information_target_n_upper_10_per_1000": 368
  }
}