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Multi-national SCCS protocol builder

Self-controlled case series. Each case acts as their own control; all time-invariant between-person confounding (genetics, lifelong habits) is automatically removed. AsPEN convention: separate a short pretreatment window (e.g., 14 days) before the first dispensing to absorb confounding by indication and benchmark the underlying-disease risk before therapy (see Wang GH et al BMJ 2021; PMID 34503972).

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The protocol builder is currently restricted to AsPEN admins.

1 · Study identification

Study title Short ID Version · Date Lead investigator(s)

2 · Research question

Population Exposure Outcome

3 · Sites

Tick every database (not just country). Feature chips indicate what each database can support — only tick a site whose features cover what your case definition / exposure / time-varying covariates need.

Legend Rx Prescriptions Dx Diagnoses Lab Lab results Img Imaging Mor Mortality linkage Can Cancer-registry linkage Preg Pregnancy / birth linkage Gen Genomics / biobank linkage

Taiwan

CGRD RxDxLabImg NHIRD RxDxLabImgMorCanPreg TWB LabGen

South Korea

HIRA RxDx NHIS-NHID RxDxLabMorCan

Japan

JMDC Claims Database RxDxLab Medical Data Vision (MDV) Database RxDxLab NDB RxDx

Hong Kong

CDARS RxDxLabImgMorCan

Australia

PBS Rx VLHD RxDxMor

Finland

FinReg RxDxMorCanPreg

United Kingdom

CPRD RxDxMorCanPreg ISD RxDxLabMorCanPreg THIN RxDx UKB LabImgMorCanGen

Netherlands

PHARMO Database Network RxDxLabMorCan

United States

20% sample RxDxMorCan Medicaid RxDxMor

Others (one per line)

⚠ Feasibility heads-up — not a blocker

Your study question implies data features that some selected sites don't carry. Multi-country SCCS protocols often accommodate this; just be explicit in the per-site analytic plan.

4 · Case definition (outcome)

Validation citation auto-appends to References on export.

Operational definition Code set Event handling

5 · Exposure definition

Exposure — name Exposure — code set Exposure period definition Days of supply default (days) Grace period (days)

6 · Design variant

SCCS variant Choose Standard when most cases have substantial unexposed time. Choose Extended when within-person unexposed time is sparse and you want to borrow strength from a never-exposed cohort. Choose Active-comparator when patients are continuously on some therapy of the same indication and the relevant question is 'drug A vs drug B'.

7 · Risk windows

Pre-risk (pretreatment) window (days) A short window immediately before first exposure, separated out to (a) absorb event-dependent exposure where the outcome itself triggers prescribing and (b) benchmark the underlying-disease risk just before therapy. AsPEN antipsychotic-falls SCCS used 14 days (Wang GH, BMJ 2021;PMID 34503972) and found the pretreatment IRR was higher than treatment IRRs — confirming underlying disease, not the drugs, drove much of the early risk. Risk window definition Post-risk window (days) Washout after exposure end, not counted as exposed or baseline. Baseline (control) period

8 · Observation period

Period starts at Period ends at Study calendar period

9 · Time-varying confounders

Age band width Adjusts for within-person ageing within the observation period. Season adjustment Other time-varying covariates (one per line)

10 · Statistical analysis

Primary model Effect estimate Meta-analysis

Subgroup analyses — tick those to perform

Age (≥65 vs <65 years) Age (≥75 vs <75 years) Sex (male vs female) Country / site First-ever vs repeated exposure Index calendar year stratum Baseline CV disease (yes vs no) Baseline CKD (eGFR <60 vs ≥60) Frailty / Charlson Comorbidity Index (high vs low) Concomitant exposure (yes vs no)

Custom subgroups (one per line)

11 · Sensitivity analyses

Alternative risk window length (e.g., 7-30, 0-90, 0-180 d) Alternative pre-risk window (0, 30, 60 d) — checks for event-dependent exposure Alternative post-risk window (washout) (0, 30, 90 d) Restrict to first event only (vs all events) Method of Farrington for event-dependent exposure (SCCS-EDE) Negative-control outcome — should show null Exclude seasonal months (if outcome is seasonal) Restrict to patients with ≥1 year of observation before first exposure Sub-divide risk window into early (0-14 d) vs late (15+ d) to look at risk attenuation

Custom sensitivity analyses (one per line)

12 · Execution & timeline

Architecture

Timeline preset

Milestones (one per line)

13 · Ethics, dissemination, references (optional)

Ethics Dissemination Key references (one per line)

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Working title

Lead — name Lead — email

Description (summary from your draft)

Sites will be carried over from your draft.

Why this study? *