Historical design document
The proposed Community Observation Program
Experience can help identify research questions. The proposed Community Observation Program would document independently occurring exposures through a defined protocol, consistent follow-up and transparent analysis. It is currently in design; health-data collection is not open.
Design document · actual participation is in the registry
Go to the Community Peptide Use Registry: contribute, my record, results and methods
How the registry would be organized
One proposed platform with two views: readers explore by reported goal or by molecule; research would happen only inside defined cohorts with study-specific protocols.
- 1 →
Goal or topic discovery
People describe what they hoped for (for example recovery or sleep). A reported goal is an intention, not an outcome and not a study entry criterion.
- 2 →
Defined condition + prespecified measurable outcome
Research cohorts are defined by a condition and an outcome chosen in advance (for example tendon pain and function on a named instrument). Broad aims such as “longevity” are not measurable endpoints.
- 3
Linked exposures and follow-up
Within a cohort, exposures are linked to the person with exact molecule, commercial product/formulation and lot where known, plus scheduled follow-up and recorded missingness.
- One platform, not separate product databases; each study has its own protocol that decides which fields are proportionate.
- Participants, exposures and outcomes have distinct denominators.
- One person can report several goals and products and appear in several reviewed aggregate views, but is counted once in overall participant counts.
- Product-only safety or quality substudies remain possible under their own protocol.
- Product information is required, but “unknown” is an allowed, explicit answer; no invented precision.
- No public vendor rankings and no dose leaderboards.
Historical note: this design proposed a pilot in one narrow cohort. That assumption is superseded: the operating registry is broad across all goals and products, and any cohort-specific analysis would be defined later. Collection status is shown on the registry pages.
Fictional example: tendon symptoms
Fictional illustration — not a real person, record or result
- Reported goal
- Recovery from an Achilles tendon problem (an intention, not an outcome).
- Cohort fit
- Would only be relevant to a defined tendon-symptom cohort with a prespecified pain and function measure.
- Baseline
- Pain and function recorded on the protocol’s instrument before follow-up begins.
- Exposure
- A product chosen independently by the person beforehand; molecule, product/formulation and lot recorded, with “unknown” where not known.
- Rehabilitation and cointerventions
- Physiotherapy exercises and reduced training recorded as concurrent changes.
- Follow-up and missingness
- Scheduled follow-up; a missed visit is recorded with its reason, not dropped.
- Interpretation
- No causal attribution: changes may reflect rehabilitation, natural course, other changes or chance.
Why a protocol, not a data dump
A pile of stories without a defined denominator cannot tell how many people tried something, how many saw no change or how many stopped. The proposed program would therefore document independently occurring exposures, recording what is unknown as well.
An anonymous survey is not automatically exempt from ethics review. Before any data are collected there must be an accountable entity, an operational contact, an ethics determination, consent and security. That work is still pending.
Four separate streams
- 01
Editorial feedback
Nonclinical education-topic feedback; separate from research consent and membership/newsletter preferences
Current state: Questionnaire preview only; no new submission endpoint created
- 02
Source corrections
Claim ID, public reference and exact page; no personal medical history or raw case upload
Current state: Proposed moderated editorial intake; publication requires review
- 03
Observational feasibility
Defined adult cohort and outcomes; retrospective and prospective records labeled distinctly
Current state: Protocol and synthetic demonstration only
- 04
Future condition-specific studies
Separate scientific question, protocol, cohort, endpoints and analysis
Current state: Concept only; not a universal peptide trial
Initial question and purpose
Proposed observational learning and research program documenting independently occurring exposures; no treatment assignment or experimentation solicitation.
Feasibility and completeness of recording identity, exposure context and comparable follow-up; not efficacy of every peptide.
Design discussion: baseline and prespecified windows suited to a condition-specific outcome. The same instrument/version and measurement method should be retained. No universal schedule is prescribed.
Analysis principles
- 1Prespecify feasibility endpoints: proportion with identifiable molecule, route, time denominator, baseline and comparable follow-up.
- 2Separate analytically characterized, documented and label-only exposures; never call self-reported identity verified.
- 3Define participant, exposure and outcome denominators separately; distinguish no events reported, not asked and unknown.
- 4Describe improvement, no change, worsening, discontinuation and loss to follow-up; no success-only testimonial selection.
- 5Stratify retrospective recall versus prospective documentation; report measurement and selection limitations.
- 6Any later comparative effectiveness question needs its own confounding strategy, comparator design, missing-data analysis and sufficient precision; feasibility data do not establish causality.
- 7No automatic best-peptide rankings, dosing recommendations or causal safety claims from volunteer counts.
What the program would document
Examples of proposed fields for a future protocol. No data are collected or stored today.
- Product identity and confidence
- Route and formulation
- Exposure timing and concurrent changes
- Baseline and comparable outcome
- New symptoms, stopping and follow-up
- Unknown or missing information
Technical data dictionary (optional)
Historical design structure, not the operating registry schema. Stable field codes remain in English.
Study
study_id · protocol_version · jurisdictions · responsible_entity · investigator_assignments · ethics_determination · enrollment_status · analysis_plan_version
Consent
study_subject_id · consent_version · locale · consent_time · scope · withdrawal_status
Study-scoped; optional recontact separate
Participant
study_subject_id · age_band · country_or_region_if_justified · eligibility_codes
Minimize; no public individual records; any recontact key separate
Exposure
exposure_id · study_subject_id · molecule_id · identity_confidence · formulation · route · mixture_type · restricted_amount_value · unit · denominator · relative_start_day · relative_stop_day · source_of_record · unknown_reason · product_id · lot_id
Study-scoped; never a public dose feed
Component
exposure_id · component_identity · declared_amount · unit · identity_confidence
One row per ingredient; unknown is explicit
Outcome
study_subject_id · outcome_id · instrument_version · value · unit · relative_day · method · reporter · baseline_source · comparability_flag · missingness_reason
Concurrent change
study_subject_id · relative_day · category · coded_change · source_of_record
Adverse event
event_id · study_subject_id · event_term · onset_relative_day · severity · seriousness_criteria · care_received · outcome · reporter_causality · adjudicated_causality_if_available · followup_status
Severity and regulatory seriousness are distinct; association is not adjudicated causality
Audit history
record_id · actor_role · timestamp · before_version · after_version · reason · protocol_version
Aggregate publication
analysis_version · cohort_definition · denominator · followup_window · missingness · disclosure_review · uncertainty · methods_url · approved_release_date
Reported goal (intention)
study_subject_id · goal_code · free_text_redacted · reported_relative_day
Intention only; never used as an outcome or eligibility
Cohort definition
cohort_id · protocol_version · condition_definition · primary_outcome_id · outcome_instrument_version · followup_schedule · proportionate_field_set
Defined condition + prespecified measurable outcome
Cohort membership
cohort_id · study_subject_id · entry_relative_day · exit_relative_day · exit_reason
A person may belong to several cohorts; counted once overall
Exact molecule
molecule_id · canonical_name · variant · is_peptide
Variants (e.g. with/without DAC) are separate entries
Commercial product / formulation
product_id · label_name · formulation · declared_components · identity_status
Unknown allowed and explicit; no public vendor ranking
Lot
lot_id · product_id · lot_code_if_known · testing_document_status
Optional per protocol; unknown is explicit
Proposed data policy
- Public datasets
- Curated source/claim metadata may be exported as a versioned evidence dataset. Never public participant-level health records or uploaded raw narratives.
- Participant imports
- Future study-scoped structured import only after authorization; validate schema/units, quarantine conflicts, verify permitted provenance and consent. Preserve raw source in restricted storage only if protocol permits.
- Uploads
- No patient-document, photo, laboratory-report or identity upload in this phase.
- Privacy
- Pseudonymized is not anonymous. Resolve controller, hosting/data transfers, retention/deletion, access, encryption, backups, incident response and disclosure review before collection.
- Publication
- Only reviewed aggregate outputs; threshold and disclosure policy must be designed for the cohort, not an invented universal k-anonymity promise.
Requirements before any activation
- 1Accountable legal operator/controller, operational contact and scientific leadership established.
- 2Versioned protocol, eligibility, outcomes and analysis plan with realistic follow-up.
- 3Qualified jurisdiction-specific ethics/regulatory/privacy determination; do not self-declare survey exemption.
- 4Appropriate informed consent, withdrawal and optional recontact process in both languages.
- 5Study-scoped access, audit, retention, security assessment and response workflow tested.
- 6Adverse-event triage/reporting responsibilities and monitoring capacity defined; emergency care is not delivered by this form.
- 7Usability/translation testing and a limited approved pilot before broader collection.
These are proposed research operating requirements, not a request to delay building the educational section or synthetic questionnaire preview.
Synthetic documentation exercise
Synthetic documentation exercise — no submissions are saved or sent
- Product identity
- SYNTHETICLabel only
- Baseline
- SYNTHETICRecalled
- Follow-up
- SYNTHETICImprovement reported
- Concurrent changes
- SYNTHETICRehabilitation, Reduced training
Interpretation: Improvement reported; identity and causal attribution unresolved.
Methods resources
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