COCHRANE ROB 2 · 偏誤風險評讀
首次進食/腸道功能恢復時間
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總體判斷 OVERALL＋Low（低風險）
Domain 與 overall 判斷由程式依 Cochrane RoB 2 官方演算法計算；AI 只負責回答下方各訊號問題。符號：＋ 低風險、？ 有些疑慮、－ 高風險（不只靠顏色）。
風險偏誤紅綠燈
- ＋Domain 1 隨機化過程：Low（低風險）
- ＋Domain 2 偏離預定介入：Low（低風險）
- ＋Domain 3 缺失結局資料：Low（低風險）
- ＋Domain 4 結局測量：Low（低風險）
- ＋Domain 5 選擇性報告：Low（低風險）
- ＋總體（Overall）：Low（低風險）
中文摘要（給一般讀者）
這篇論文的偏誤風險與 limitation
本試驗為四中心、假電針對照的隨機臨床試驗，採動態區組隨機、中央網路化分派並依醫院分層，分派隱蔽充分，基線特徵兩組相近，隨機化領域風險低。針對「首次進食／腸道功能恢復時間」此次要結果，採意向治療分析；雖施針者未設盲，但病人、外科醫師與結果評估者均設盲且盲性經查核驗證，無證據顯示因試驗情境而起、不符方案的偏離，亦未影響測量。結果由設盲病人以日誌記錄、設盲評估者每日查核，測量方法適當且組間一致。缺失資料極少（僅約1人完全缺值），未插補但敏感度分析一致，不致造成偏誤。試驗事前註冊且分析計畫載於補充資料，結果係依預定計畫與單一定義分析報告，無選擇性報告之虞，整體各領域偏誤風險低。
詳細評讀（給專業讀者）
Domain 1：隨機化過程 — 判斷：Low
偏誤來源：隨機分組的過程——分配序列是否隨機產生、是否隱蔽到分組為止、基線（第一期開始時）是否平衡。
1.1 Was the allocation sequence random?
分配序列是否隨機產生？
- 回答：是（Yes — 有明確證據支持）
- 原文引述：Eligible postoperative patients were randomly assigned (1:1) to the EA group or the sham electroacupuncture (SA) group using dynamic block randomization. Randomization was achieved via a central web-based system for clinical research (Yale Joint Center for Biostatistics) and stratified within the 4 enrollment hospitals. The randomization sequence was created by a statistician who did not participate in the study.符合資格的術後病人以動態區組隨機（1:1）分派至電針組或假電針組；隨機化透過中央網路系統（Yale Joint Center for Biostatistics）執行，並依四家收案醫院分層。隨機序列由一位未參與研究的統計師產生。
- 理由：明確使用動態區組隨機並由獨立統計師以中央網路系統產生序列，含明確隨機成分，屬適當的隨機序列產生。
1.2 Was the allocation sequence concealed until participants were enrolled and assigned to interventions?
分配是否隱蔽到分組為止？
- 回答：是（Yes — 有明確證據支持）
- 原文引述：Randomization was achieved via a central web-based system for clinical research (Yale Joint Center for Biostatistics) ... Patients were randomly assigned to treatment group by a central system.隨機化透過中央網路系統執行……病人由中央系統隨機分派至治療組。
- 理由：採中央網路化隨機分派系統，分派由獨立外部單位控制，收案人員無法預知下一個分派，屬適當的分派隱蔽。
1.3 Did baseline differences between intervention groups suggest a problem with the randomization process?
（第一期開始時）基線差異是否暗示隨機化有問題？
- 回答：可能否（Probably no — 綜合判斷後傾向「否」）
- 原文引述：The patients in the 2 groups had similar baseline characteristics (Table 1).兩組病人的基線特徵相似（表1）。
- 理由：表1所列年齡、BMI、腫瘤分期、手術類型等基線特徵兩組相近，組別人數亦接近1:1（125 vs 123），無顯示隨機過程出問題的不平衡。
Domain 2：偏離預定介入 — 判斷：Low
偏誤來源：實際執行時偏離預定的介入——盲性如何、是否依「隨機分到的組別」分析（ITT）。
2.1 Were participants aware of their assigned intervention during the trial?
參與者是否（在每一期）知道自己的分組？
- 回答：否（No — 有明確證據支持）
- 原文引述：Patients, surgeons, and outcome assessors were masked to group assignment, but acupuncturists were not. ... In the masked assessment, no between-group difference was found in the proportion of patients who guessed that they received acupuncture.病人、外科醫師與結果評估者均對分組設盲，但施針者未設盲。……在盲性評估中，兩組猜測自己接受真針灸的比例並無差異。
- 理由：假電針採真針淺刺非穴位、相同貼電極外觀，盲法經先前研究驗證，且盲性查核顯示兩組猜中比例無差異，故病人未察覺其分派。
2.2 Were carers and people delivering the interventions aware of participants' assigned intervention during the trial?
照護／執行者是否（在每一期）知道分組？
- 回答：是（Yes — 有明確證據支持）
- 原文引述：Patients, surgeons, and outcome assessors were masked to group assignment, but acupuncturists were not.病人、外科醫師與結果評估者均對分組設盲，但施針者未設盲。
- 理由：施針者（執行介入者）知悉分組；外科醫師等其他照護人員雖設盲，但實際執行介入的施針者未盲，故照護/執行介入者知悉分派。
2.3 Were there deviations from the intended intervention that arose because of the trial context?
是否因試驗情境造成偏離？
- 回答：可能否（Probably no — 綜合判斷後傾向「否」）
- 原文引述：We conducted our analyses using the intention-to-treat principles regardless of whether patients had received the assigned intervention or completed all treatment sessions. ... Treatment-related AEs were mild and transient.我們依意向治療原則分析，不論病人是否接受所分派的介入或完成全部治療。……治療相關不良事件皆輕微且短暫。
- 理由：施針者雖未盲，但介入為標準化、固定穴位的短療程，無證據顯示因試驗情境導致偏離方案的處置；兩組照護均在相同ERAS方案下進行，未見因試驗情境而起、且不符方案的偏離。
2.4 Were these deviations likely to have affected the outcome?
這些偏離是否可能影響結局？
- 回答：不需評估（NA）
- 原因：條件題：依 2.3 的答案，本題依 RoB 2 官方路由不需評估（NA）。
2.5 Were these deviations from intended intervention balanced between groups?
這些偏離在兩組間是否平衡？
- 回答：不需評估（NA）
- 原因：條件題：依 2.4 的答案，本題依 RoB 2 官方路由不需評估（NA）。
2.6 Was an appropriate analysis used to estimate the effect of assignment to intervention?
是否用了適當分析（ITT）？
- 回答：是（Yes — 有明確證據支持）
- 原文引述：We conducted our analyses using the intention-to-treat principles regardless of whether patients had received the assigned intervention or completed all treatment sessions. ... Thus, 125 patients in the EA group and 123 in the SA group were included in the intention-to-treat analyses.我們依意向治療原則進行分析，不論病人是否接受所分派介入或完成全部療程……因此電針組125位、假電針組123位納入意向治療分析。
- 理由：明確採意向治療分析，依分派組別分析；唯一排除者為隨機後確診腸結核（不符合資格、與分派無關）的1人，屬可接受的隨機後排除。
2.7 Was there potential for a substantial impact (on the result) of the failure to analyse participants in the group to which they were randomized?
未依隨機分組分析，是否可能對結果造成重大影響？
- 回答：不需評估（NA）
- 原因：條件題：依 2.6 的答案，本題依 RoB 2 官方路由不需評估（NA）。
Domain 3：缺失結局資料 — 判斷：Low
偏誤來源：結局資料缺失——是否幾乎所有人都有資料、缺失是否可能與病情（結局真實值）相關。
3.1 Were data for this outcome available for all, or nearly all, participants randomized?
是否幾乎所有受試者都有此結局的資料？
- 回答：可能是（Probably yes — 綜合判斷後傾向「是」）
- 原文引述：Secondary outcomes in the observed cases were analyzed without imputation of missing data. ... Six patients withdrew from the trial because of the lack of efficacy (n = 1), withdrawal of consent (n = 2), or AEs (n = 3).次要結果以觀察到的病例分析、未對缺失資料插補。……六位病人退出試驗（無效n=1、撤回同意n=2、不良事件n=3）。
- 理由：248位隨機病人中僅6位退出，且文中指出多數退出者仍記錄了結果資料；此首次進食/腸道功能恢復屬次要結果、未插補但缺失極少，資料近乎涵蓋全部病人。
3.2 Is there evidence that the result was not biased by missing outcome data?
是否有證據顯示結果未受缺失資料偏誤？
- 回答：不需評估（NA）
- 原因：條件題：依 3.1 的答案，本題依 RoB 2 官方路由不需評估（NA）。
3.3 Could missingness in the outcome depend on its true value?
缺失是否可能取決於結局真實值？
- 回答：不需評估（NA）
- 原因：條件題：依 3.2 的答案，本題依 RoB 2 官方路由不需評估（NA）。
3.4 Is it likely that missingness in the outcome depended on its true value?
缺失是否很可能取決於結局真實值？
- 回答：不需評估（NA）
- 原因：條件題：依 3.3 的答案，本題依 RoB 2 官方路由不需評估（NA）。
Domain 4：結局測量 — 判斷：Low
偏誤來源：結局的測量——測量工具是否恰當、評估者是否盲化、評估是否可能受分組知情影響。
4.1 Was the method of measuring the outcome inappropriate?
結局測量方法是否不適當？
- 回答：可能否（Probably no — 綜合判斷後傾向「否」）
- 原文引述：The exact time of first occurrence of these events and severity of symptoms were recorded in a diary by patients and caregivers, and the completion of diary status was checked daily by local outcome assessors during hospitalization.這些事件首次發生的確切時間與症狀嚴重度由病人與照護者記錄於日誌，住院期間由當地結果評估者每日查核日誌完成狀況。
- 理由：以日誌記錄首次耐受半流質/固體飲食等腸道功能恢復時間，並由評估者每日查核，對此類臨床事件而言屬適當的測量方法，無不當之處。
4.2 Could measurement or ascertainment of the outcome have differed between intervention groups?
（每一序列內）結局測量是否可能因介入而異？
- 回答：可能否（Probably no — 綜合判斷後傾向「否」）
- 原文引述：The exact time of first occurrence of these events and severity of symptoms were recorded in a diary by patients and caregivers, and the completion of diary status was checked daily by local outcome assessors ... Patients, surgeons, and outcome assessors were masked to group assignment.事件首次發生時間由病人與照護者記錄於日誌、評估者每日查核；病人、外科醫師與結果評估者均對分組設盲。
- 理由：兩組使用相同的日誌記錄與查核方式測量結果，方法一致，且病人與評估者皆設盲，組間測量方式不致有別。
4.3 Were outcome assessors aware of the intervention received by study participants?
結局評估者是否知道受試者接受的介入？
- 回答：否（No — 有明確證據支持）
- 原文引述：Patients, surgeons, and outcome assessors were masked to group assignment, but acupuncturists were not.病人、外科醫師與結果評估者均對分組設盲，但施針者未設盲。
- 理由：結果由設盲的病人/照護者記錄並由設盲的結果評估者查核；唯一未盲者為施針者，但其不負責結果評估，故結果評估者不知悉所接受的介入。
4.4 Could assessment of the outcome have been influenced by knowledge of intervention received?
結局評估是否可能受介入知情影響？
- 回答：不需評估（NA）
- 原因：條件題：依 4.3 的答案，本題依 RoB 2 官方路由不需評估（NA）。
4.5 Is it likely that assessment of the outcome was influenced by knowledge of intervention received?
結局評估是否很可能受介入知情影響？
- 回答：不需評估（NA）
- 原因：條件題：依 4.4 的答案，本題依 RoB 2 官方路由不需評估（NA）。
Domain 5：選擇性報告 — 判斷：Low
偏誤來源：選擇性報告結果——是否依事前訂定的分析計畫分析、有無從多個結果中挑選有利者報告（交叉另含：是否因偵測到殘留而只報第一期）。
5.1 Were the data that produced this result analysed in accordance with a pre-specified analysis plan that was finalized before unblinded outcome data were available for analysis?
是否依事前訂定（取得未盲化資料前定版）的分析計畫分析？
- 回答：可能是（Probably yes — 綜合判斷後傾向「是」）
- 原文引述：Details of trial design and analysis plans are presented in Supplement 1. ... The study was registered at the Chinese Clinical Trial Registry. ... TRIAL REGISTRATION Chinese Clinical Trial Registry Identifier: ChiCTR2000038444試驗設計與分析計畫的細節見補充資料1……研究已在中國臨床試驗註冊中心註冊（ChiCTR2000038444）。
- 理由：試驗事前註冊且分析計畫載於補充資料、明列ITT分析與統計方法，腸道功能恢復時間屬預先指定的次要結果，研判係依事先計畫分析，故給PY而非常規NI。
5.2 Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible outcome measurements (e.g. scales, definitions, time points) within the outcome domain?
此數值結果是否可能依結果，從多個量表／定義／時間點中選出？
- 回答：可能否（Probably no — 綜合判斷後傾向「否」）
- 原文引述：Secondary outcomes included the time to first flatus (with bowel sound to recover), first tolerance of semiliquid diet, first tolerance of solid food, and first ambulation ... The exact time of first occurrence of these events ... were recorded in a diary.次要結果包含首次排氣時間、首次耐受半流質飲食、首次耐受固體食物及首次下床活動……這些事件首次發生的確切時間記錄於日誌。
- 理由：腸道功能恢復各時間點為單一明確定義的測量（首次耐受半流質/固體飲食、首次排氣），預先指定且依固定定義報告，未見從多種量表或定義中擇優報告的跡象。
5.3 Is the numerical result being assessed likely to have been selected, on the basis of the results, from multiple eligible analyses of the data?
此數值結果是否可能依結果，從多種分析中選出？
- 回答：可能否（Probably no — 綜合判斷後傾向「否」）
- 原文引述：an independent t test was used for normally distributed values, and the Mann-Whitney U test was used for skewed data. ... All analyses were performed using SAS software ... by an independent statistician.常態分布資料用獨立t檢定、偏態資料用Mann-Whitney U檢定……所有分析由獨立統計師以SAS軟體執行。
- 理由：分析方法事前依資料分布型態指定、由獨立統計師執行，各時間點皆以一致方法報告效果量與P值，未見從多種分析中擇優報告的跡象。
