Study planning

Flows for this purpose

• Study overview

  Question → objectives → population → comparison → endpoints → study approach

• Study arms and assignments

  Eligible participant → assignment approach → study arms → intervention or comparator

• Endpoint map

  Objectives → primary, secondary, exploratory and safety endpoints → assessment definitions

• Assessment and follow-up schedule

  Entry or index → baseline → assessments → end of follow-up

• Estimand specification

  Question → population and conditions → outcome → intercurrent-event strategy → summary measure

• Target trial specification

  Target protocol → eligibility and strategies → assignment emulation → aligned time zero → follow-up and estimand

• Variables and outcomes

  Define measurements and event ascertainment

• Endpoints and measurements

  Define exposures outcomes and assessments

• Endpoints and estimands

  Define objectives outcomes and effects

• Index and reference testing

  Specify thresholds blinding and timing

• Follow-up and safety

  Plan assessments monitoring and disposition

• Endpoints and benchmark rationale

  Define outcomes and comparison basis

• Recruitment and intervention delivery

  Assess enrollment adherence and procedures

• Feasibility endpoints and progression

  Define criteria for study progression

• Target trial specification

  Define hypothetical trial and estimands

• Time-series intervention and comparison definition

  Specify timing controls and mechanisms

• Frozen model and validation population

  Define frozen model and applicability

• Crossover treatment periods and washout

  Specify period timing and carryover

• Crossover endpoints and estimands

  Define period outcomes and effects

• Factor definitions and estimands

  Define main effects and interactions

• Cluster allocation and intervention delivery

  Specify assignment contamination and implementation

• Cluster trial endpoints and estimands

  Define cluster and individual effects

• Stepped-wedge rollout and transitions

  Assign sequences periods and transitions

• Stepped-wedge endpoints and estimands

  Define effects and exposure duration

• Dosing and toxicity assessment windows

  Specify schedules toxicity and activity

• Platform arm lifecycle and allocation

  Track entry closure and assignment

• Platform endpoints, estimands and comparisons

  Define arm-specific questions and populations

• Outcomes and estimands

  Define outcomes and comparison targets

• Scoping review overview — Scoping review

  Scope through evidence mapping

• Review overview — Systematic review without meta-analysis

  Question through structured synthesis

• Review overview — Systematic review with pairwise meta-analysis

  Question through evidence interpretation

• Diagnostic review overview — Systematic review of diagnostic test accuracy

  Question through test evidence interpretation

• Participant-data review overview — Systematic review with individual participant data meta-analysis

  Question through participant-level synthesis

• Network review overview — Systematic review with network meta-analysis

  Question through network comparison

• Cross-sectional study overview — Cross-sectional study

  Question through population snapshot reporting

• Cohort overview — Retrospective descriptive cohort

  Question through longitudinal study reporting

• Cohort overview — Prospective observational cohort

  Question through prospective study reporting

• Case-control overview — Case-control study

  Question through exposure association reporting

• Nested study overview — Nested case-control study

  Question through sampled cohort analysis

• Comparative study overview — Comparative cohort using existing data

  Question through comparative effect interpretation

• Time-series study overview — Interrupted time-series study

  Question through intervention impact reporting

• Comparative change overview — Difference-in-differences study

  Question through comparative change interpretation

• Self-controlled study overview — Self-controlled case series

  Question through within-person incidence comparison

• Emulation overview — Target trial emulation

  Question through causal effect interpretation

• Diagnostic study overview — Diagnostic accuracy study

  Clinical question through accuracy interpretation

• Validation study overview — External prediction model validation

  Existing model through independent evaluation

• Prediction study overview — Clinical prediction model development

  Intended use through model reporting

• Feasibility study overview — Pilot or feasibility trial

  Question through future-study decisions

• Single-arm study overview — Single-arm interventional study

  Question through intervention study reporting

• Trial overview — Parallel-group randomized trial

  Question through randomized trial reporting

• Comparative intervention overview — Nonrandomized comparative interventional study

  Question through nonrandomized intervention reporting

• Crossover trial overview — Randomized crossover trial

  Question through within-participant trial reporting

• Factorial trial overview — Factorial randomized trial

  Question through combined intervention evaluation

• Cluster trial overview — Cluster-randomized parallel trial

  Question through clustered trial reporting

• Dose-finding study overview — Dose-escalation and dose-finding study

  Question through dose recommendation

• Stepped-wedge trial overview — Stepped-wedge cluster trial

  Question through phased rollout evaluation

• Adaptive trial overview — Adaptive randomized trial

  Question through adaptive trial reporting

• Platform trial overview — Platform trial

  Master question through evolving comparisons