D57: run-time trims (V3 skipped where physician plays no role, NCE without V3, landmark_m5 under V1 only)
Co-Authored-By: Claude Opus 5.5 <[email protected]>
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@@ -118,3 +118,4 @@ Each decision is listed with the date and the reason for it. Settled decisions a
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| 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. |
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| 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. |
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| 56 | **Primary outcome changed to limb MALE: the first of coded CLTI, major amputation or open bypass** (user, 2026-10-28). D7's MALE (which also counts any revascularization after the first) moves to the supplement as "MALE including repeat revascularization". Repeat revascularization is reported on its own as a physician-driven outcome. Limb MALE also replaces the disease composite (CLTI or amputation) as the headline (D34); the disease composite stays as a secondary outcome. Negative-control bias (Aim 3) is now measured on limb MALE. Clean-world truths: 0 under the null (exactly); +6.2 under harm; −0.7 at 12 months, −1.7 at 24 and +3.6 at 60 under benefit-then-harm. Acute limb ischemia is not simulated (rare in claudication; limitation). | Standard MALE definitions (Conte 2009 *JVS* 19897335; Nordanstig 2024 *EJVES* 39121905) are built for follow-up **after** a revascularization: reintervention exists only for treated patients. D7 argued that excluding the index PVI in both arms made the outcome symmetric. It does not: under A everyone is at risk of a repeat for about 55 months, under B1 about 3.6% are. In the clean world under the null, repeat revascularization is 18.6% vs 0.7%, giving +14 pp of MALE from the definition alone. |
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| 57 | **Run-time trims** (user, 2026-10-28). One replicate is about 77 s of compute, half of it in the random-intercept variant (V3). Trims: `landmark_m5` runs under V1/V2 only (supplement); the NCE runs under V1/V2 and V4, not V3; V3 is skipped in W0 and W4, where the physician plays no role by design. V3 stays in W1, W1_rho0, W2, W3, W5, WE and WR. About 20–25% less run time. The run is started manually when the laptop is plugged in (`nohup caffeinate -i -s zsh results/run_v2.sh &`), at nice 10. | Faster, with no loss for the main text. |
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