Research planning and methods-readiness watcher

Turn a rough clinical study idea into a protocol-ready checklist.

StudyVahti maps early study ideas to PICOTS, protocol/reporting standards, bias domains, estimand logic, feasibility assumptions, and places where statistical or methodological review is needed before protocol drafting.

1. Study Identity

Define the clinical question, study pathway, and intended estimand before asking for artifacts.

Working title

Disease area

Question type

Study design

Analysis target

Data source

Research question

2. PICOTS

StudyVahti is strict here because vague populations, comparators, timing, or settings become vague analyses.

Population

Exposure or intervention

Comparator

Primary outcome

Time zero

Follow-up

3. Variables And Codebook

Use stable variable names, roles, and coding notes so data provenance and analysis assumptions stay inspectable.

Recommended packs update from the current study setup.

Variable audit updates as rows are added.

Variable coding plan

Variable packs append modular rows and skip duplicate names. Format: variable_name | label | type | role | allowed values or coding note

Primary exposure variable

Primary outcome variable

Survival time variable

Planned adjustment variables

4. Bias And Causal Validity

These checks are mapped to target-trial thinking, nonrandomized-study bias domains, and transparent reporting expectations.

5. Feasibility And Power Readiness

StudyVahti records sample, event, precision, and governance assumptions. It does not replace a formal sample-size calculation.

Expected sample size

Expected event rate

Minimum useful effect

Feasibility notes

Readiness Sheet

Generated locally from the fields above.

Generate the readiness sheet to see the protocol-planning output.

Planning Cockpit

Gate status and open planning decisions generated from the same fields.

Generate the readiness sheet to see planning gates.

Generate the readiness sheet to see the planning ledger.

Local Artifacts

Scaffolds only. Review before using in a protocol, analysis plan, or repository.

Generate the readiness sheet to create local artifacts.

Workflow

Idea Capture question and PICOTS.
Variables Create a codebook-ready skeleton.
Bias Flag design and causal risks.
Decision Triage readiness for protocol drafting.
Artifacts Export local scaffolds only.

Scientific Backbone

PICOTS / AHRQQuestion structure: population, intervention or exposure, comparator, outcome, timing, and setting.
SPIRIT 2025 / CONSORT 2025Trial protocol and reporting completeness for randomized or prospective interventional work.
STROBE / RECORDObservational and routinely collected health-data transparency, including selection, variables, and data linkage.
Target Trial / ROBINS-ICausal observational studies are treated as attempts to emulate a clearly specified randomized trial.
STARD / TRIPOD+AI / PROBAST+AIDiagnostic accuracy and prediction-model studies need transparent test, model, validation, bias, and applicability planning.
SRQR / COREQ / SQUIRE 2.0Qualitative, mixed-methods, and care-improvement pathways need explicit context, theory, reflexivity, and intervention logic.
PRISMA 2020 / CHEERS 2022Evidence synthesis and health-economic evaluations need search, selection, cost, outcome, uncertainty, and decision-context structure.

State Language

State	Meaning
[oo]	Ready for protocol drafting after human methods review where required.
[o]	Needs support before it is ready to draft.
[r]	Methods review needed due to causal, survival, mixed-methods, or feasibility risk.
[d]	Not ready; the study identity is too incomplete.

Integrity Boundary

No clinical, ethical, statistical, or funding approval.
No backend, telemetry, credential storage, or hidden writes.
Generated R and CSV files are starting points, not validated analysis code.
Framework mapping is not evidence appraisal, risk-of-bias rating, or checklist completion.
Any causal or inferential study should involve a qualified methodologist.