CSP+K — HRV summary dataset & analysis code (v1.5.1 REPRO READY)

Japanese summary本パッケージは、論文本文の主要臨床解析(患者レベル**≥80% responder**、非調整ARD+Newcombe 95%CI+Fisher)に整合したHRV支持解析(AAW)の再現アーカイブです。臨床個票は含まず、HRVの要約データと実行コードのみを配布します。本文のセッション判定は階層ルール(同日優先/同日が無ければ次回受診)で定義されており、本パック内では参照のみ明記します(臨床データは配布しません)。 English (primary) Title. CSP+K HRV supportive dataset & code — v1.5.1 (REPRO) Scope & alignment. This repository distributes HRV supportive physiology only for the CSP+K program. It aligns with the manuscript’s design posture: the primary clinical endpoint is patient‑level responder = ≥80% of rated sessions “improved”, with session ratings captured via a hierarchical source rule (same‑day pre‑discharge preferred; else first follow‑up explicitly attributing the index session). The clinical endpoints are not distributed here; this pack contains anonymized HRV summary counts and reproducible code implementing design‑based contrasts (AAW = ΔHR<0 ∧ ΔRMSSD>0; Newcombe 95% CIs; two‑sided Fisher). What’s included. data/ HRV summary tables (same‑session pairs; pooled 3‑ and 5‑min; ≤5% artifact; ≤3% HQ subset). code/analysis.py Reproducible analysis producing AAW risk differences (Newcombe 95% CIs) & Fisher p and PNG bar plots. docs/SAP_v1.5.0.md Statistical Analysis Plan (supportive HRV only); CODEBOOK.md; SOP_excerpt.md. CITATION.cff (Concept DOI) and dual licenses (LICENSE-CODE, LICENSE-DATA). How to reproduce. python -m pip install -r code/requirements.txtpython code/analysis.py# outputs:# code/Summary_RD_Newcombe.csv# code/figures/bar_overall.png, bar_3min.png, bar_5min.png Analytical posture. No covariate adjustment / no model‑based regression. We report absolute risk differences (ARD) with Newcombe 95% CIs and Fisher’s exact p‑values; design‑based robustness only. This mirrors the manuscript’s unadjusted, patient‑level primary analysis (responder = ≥80% improved under an IV‑dominant assignment). Versioning & DOIs. Concept DOI (cite in manuscript): 10.5281/zenodo.1739113110 Version DOI (this snapshot): (auto‑assigned on publish; add here after release)The Supplement cites the Version DOI for this exact snapshot; the article cites the Concept DOI. Licensing. Code and data use separate licenses; see LICENSE-CODE and LICENSE-DATA. How to cite. Cite the Concept DOI above and the article:“Association of high‑thoracic epidural priming with higher effectiveness at lower ketamine dose in outpatient care: a single‑center cohort.” (MCPIQO, Original Research). The cover letter and manuscript explicitly present the patient‑level ≥80% responder definition and unadjusted ARD with Newcombe CIs. What’s new in v1.5.1. Fixed the analysis runner; clarified alignment with the manuscript (patient‑level ≥80%, hierarchical rating source); removed S‑ROB1/logistic/IPTW mentions; design‑based RD + Newcombe + Fisher only (no data changes). Package structure (excerpt). CSPK_HRV_Public_v1.5.1_REPRO/ README.md, VERSION, CHANGELOG.md, CITATION.txt, CITATION.cff code/ analysis.py # design-based RD (Newcombe 95% CI) + Fisher; outputs CSV & PNGs requirements.txt figures/ # outputs appear here data/ cspk_hrv_pairs_v1.4.csv hrv_counts_by_length_v1.4.csv hrv_counts_overall_v1.4.csv docs/ SAP_v1.5.0.md SOP_excerpt.md CODEBOOK.md Keywords. HRV; RMSSD; ketamine; cervical epidural; outpatient; design‑based inference; absolute risk difference; Newcombe CI; Fisher exact; real‑world evidence.### 日文摘要 本软件包为与论文正文核心临床分析（患者层面≥80%应答者（responder）、未校正绝对风险差（absolute risk difference, ARD）+纽科姆95%置信区间（Newcombe 95% confidence interval, Newcombe 95%CI）+费希尔精确检验（Fisher's exact test, Fisher））相契合的心率变异性（Heart Rate Variability, HRV）支持性分析（AAW）可复现归档包。本包不包含临床个体数据，仅公开心率变异性汇总数据与可复现代码。论文正文的疗程判定采用层级规则（优先同日就诊；若无同日就诊则采用下次复诊），本包仅作参考说明（临床数据不对外分发）。 ### 英文原文翻译 #### 标题 CSP+K心率变异性（HRV）支持数据集与代码 — v1.5.1（可复现版） #### 范围与契合度 本仓库仅针对CSP+K项目分发心率变异性（HRV）支持性生理学数据。其与论文的设计框架保持一致：核心临床终点为患者层面的应答者定义为≥80%的评定疗程“改善”，疗程评定通过层级来源规则获取（优先出院前当日评定；若无则采用明确关联基线疗程的首次随访）。本仓库不包含临床终点数据；本软件包仅包含匿名化的心率变异性汇总统计量与实现基于设计对比的可复现代码（AAW定义为ΔHR<0且ΔRMSSD>0；纽科姆95%置信区间；双侧费希尔精确检验）。 #### 包含内容 1. `data/`：HRV汇总表（同疗程配对数据；合并3分钟与5分钟时长数据；伪影占比≤5%；高质量子集占比≤3%）。 2. `code/analysis.py`：可复现分析代码，可生成AAW风险差（纽科姆95%置信区间）、费希尔精确检验P值及PNG格式柱状图。 3. `docs/SAP_v1.5.0.md`：统计分析计划（仅针对心率变异性支持性分析）；`CODEBOOK.md`；`SOP_excerpt.md`。 4. `CITATION.cff`（概念DOI）与双重许可协议（`LICENSE-CODE`、`LICENSE-DATA`）。 #### 复现步骤 bash python -m pip install -r code/requirements.txt python code/analysis.py # 输出结果： # code/Summary_RD_Newcombe.csv # code/figures/bar_overall.png, bar_3min.png, bar_5min.png #### 分析框架 无协变量校正/无基于模型的回归分析。本研究报告绝对风险差（ARD）搭配纽科姆95%置信区间与费希尔精确检验P值；仅采用基于设计的稳健性分析。这与论文中未校正的、患者层面的核心分析保持一致（应答者定义为在工具变量（instrumental variable, IV）主导分配下≥80%疗程改善）。 #### 版本管理与DOI - 概念DOI（需在论文中引用）：10.5281/zenodo.1739113110 - 版本DOI（本快照版本）：（发布时自动分配；发布后补充至此处） 补充说明：补充材料引用本精确快照的版本DOI，论文引用概念DOI。 #### 许可协议 代码与数据采用分开的许可协议；详见`LICENSE-CODE`与`LICENSE-DATA`。 #### 引用方式 请引用上述概念DOI及对应论文： >"Association of high‑thoracic epidural priming with higher effectiveness at lower ketamine dose in outpatient care: a single‑center cohort."（MCPIQO，原创研究） 附信与论文中明确说明了患者层面≥80%应答者的定义，以及未校正的绝对风险差（ARD）搭配纽科姆置信区间的分析方法。 #### v1.5.1版本更新内容 修复了分析运行脚本；明确了与论文的契合点（患者层面≥80%应答者、层级化疗程评定来源）；移除了S-ROB1/逻辑回归/逆概率加权（inverse probability of treatment weighting, IPTW）相关提及；仅保留基于设计的风险差（RD）+纽科姆置信区间+费希尔精确检验分析（无数据变更）。 #### 软件包结构（节选） CSPK_HRV_Public_v1.5.1_REPRO/ README.md, VERSION, CHANGELOG.md, CITATION.txt, CITATION.cff code/ analysis.py # 基于设计的风险差（Newcombe 95% CI）分析 + 费希尔精确检验；输出CSV与PNG文件 requirements.txt figures/ # 分析输出结果存放于此 data/ cspk_hrv_pairs_v1.4.csv hrv_counts_by_length_v1.4.csv hrv_counts_overall_v1.4.csv docs/ SAP_v1.5.0.md SOP_excerpt.md CODEBOOK.md #### 关键词 心率变异性（HRV）；根均方差（Root Mean Square of Successive Differences, RMSSD）；氯胺酮；颈段硬膜外阻滞；门诊诊疗；基于设计的推断；绝对风险差；纽科姆置信区间；费希尔精确检验；真实世界证据。