D55: EHR/registry-like world (noisy severity), non-random trial consent, trial analyses at 12/24/60 months

Co-Authored-By: Claude Opus 5.5 <[email protected]>
2026-10-28 16:26:01 -04:00
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@@ -116,3 +116,4 @@ Each decision is listed with the date and the reason for it. Settled decisions a
 | # | Decision | Why |
 |---|---|---|
 | 54 | **The paper's question: "Can target trial emulation overcome the problems that make randomized trials hard in surgery?"** Early PVI for claudication is the worked example. Medicare only supplies realistic simulation inputs, and the paper makes no claims about Medicare findings or the authors' earlier papers. The structure is a scorecard: each surgical-RCT barrier (small/stopped early, short follow-up/soft endpoints, crossover, selected surgeons, practice style, unmeasured severity) against whether TTE solves it, checked against the known truth. Aims 1–3 stay. Aim 1 = "TTE is not one method", Aim 2 = the scorecard rows, Aim 3 = whether the one unfixable problem can be detected. The MALE/repeat-revascularization point is secondary, general outcome-definition guidance. The Medicare "dial" idea is dropped. **Novelty (quick PubMed check, 2026-10-28):** there are TTE guides for surgeons (e.g. JBJS Rev 2026) and immortal-time design comparisons (Duchesneau 2022 *CEBP*), but no search hit for a known-truth simulation comparing TTE with a feasible surgical RCT under surgeon-level threats. | User: the aim is to test whether TTE can solve RCT challenges in surgery, without arguing against the authors' earlier results. |
+| 55 | **Three additions from literature review 3 (user, 2026-10-28), for the overnight run.** (1) **New world WE, "EHR/registry-like":** the same DGP and calibration as W0, but the analyst sees severity with measurement error (monthly Z_t + N(0, 0.75²), correlation with true severity about 0.8), a frailty index with reliability 0.7, and true smoking. It sits between W0 (exact) and W5 (claims proxy) and answers the claims-vs-EHR row of Table 1. (2) **Non-random consent in the realistic trial:** mean 30%, OR 0.7 per 10 years of age and per SD of frailty (Wasmann 2019, King 2005). The trial's ITT truth is weighted by consent probability. (3) **Trial horizons 12, 24 and 60 months:** ITT and as-treated at each. Truths `rct_<design>_itt_h12/_h24`. The reference at the short horizons is RD(A − B1) at that month, from the risk curves. **Learning curve:** not simulated; limitation (user). | Completes Table 1 rows 3, 5 and 17. |