COCHRANE ROB 2 · 偏誤風險評讀
治療有效率（response rate，第4週）
← 回到「消化不良」的圖表
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
本試驗為多中心、假針灸對照、1:1隨機分組的隨機臨床試驗，評讀終點為第4週「治療有效率」（患者自評整體改善，屬主觀結果）。隨機由生物統計學家以分層區組（區組6）產生序列、並經中央網路系統分配，序列產生與分配隱匿均適當，基線平衡，隨機領域風險低。分析採全體隨機者ITT、缺失值多重插補，並有型態混合模型敏感度分析；雖整體約18%退出且第4週前已有相當缺失，但插補與敏感度分析支持結果穩健。施針者未盲化，但患者、結果評估者與統計者皆盲化且盲化檢測成功，主觀結果的測量偏誤風險低；主要終點與分析方法均事前登記、依計畫報告。整體而言各領域偏誤風險偏低。
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：Patients were randomly assigned in a 1:1 ratio to receive either acupuncture or sham acupuncture by a central web-based randomization system (Beijing Guide Technology Center). Stratified block randomization was used, and block size was set at 6. A randomization sequence was created by a biostatistician who did not participate in this trial.患者以1:1比例經中央網路隨機系統（北京匯智科技中心）隨機分配接受針灸或假針灸。採用分層區組隨機，區組大小設為6。隨機序列由未參與本試驗的生物統計學家產生。
- 理由：由生物統計學家以分層區組方式產生隨機序列，含真正的隨機成分，序列產生方法明確且適當。
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：by a central web-based randomization system (Beijing Guide Technology Center)經中央網路隨機系統（北京匯智科技中心）。
- 理由：採用中央網路隨機系統分配，由獨立於收案人員的外部單位控制配置過程，屬適當的分配隱匿，招募者無法預知下一個分組。
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：否（No — 有明確證據支持）
- 原文引述：Patient demographic characteristics were similar between the groups at baseline (Table 1). ... There were no significant differences (P < 0.05) between the study groups.兩組基線人口學特徵相似（表1）……兩組間無顯著差異（P<0.05）。
- 理由：兩組各138與140人，接近1:1配置；表1各項基線特徵相似、無顯著差異，未見提示隨機過程有問題的不平衡。
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：Superficial skin penetration (2 to 3 mm in depth) at nonacupoints was done in the sham acupuncture group without de qi manipulations. ... no difference was found between groups in the proportion of patients who guessed that they received acupuncture at the first and sixth sessions (P = 0.72 and 0.69, respectively).假針灸組於非穴位處淺刺（深2至3公釐）且不行得氣操作……第一次與第六次治療時，兩組猜測自己接受真針灸的比例無差異（P分別=0.72、0.69）。
- 理由：設有假針灸對照，盲性檢測顯示兩組患者猜測分組比例無差異，盲化成功，患者不知自己的分組。
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：Acupuncturists were not blinded to the treatment.施針者未對治療分組盲化。
- 理由：施針者（介入提供者）明確未盲化，知道患者所屬分組。
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：Patients received twelve 20-minute sessions of acupuncture or sham acupuncture [3 sessions per week ... for 4 weeks]. Both acupuncture and sham acupuncture were done by licensed acupuncturists with at least 3 years of experience.患者接受12次、每次20分鐘的針灸或假針灸（每週3次，共4週）。真假針灸均由具至少3年經驗的合格針灸師執行。
- 理由：兩組均依標準作業流程由合格針灸師執行、療程一致；未見因試驗情境導致偏離方案的非方案介入或方案未落實的證據。
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：All statistical analyses were based on the intention-to-treat population of all randomly assigned participants, with a 2-sided significance level of less than 0.05. ... Missing data on the primary outcomes were multiply imputed using the monotone regression option in SAS PROC MI.所有統計分析以全部隨機分配患者的意向治療族群為基礎，雙側顯著水準小於0.05……主要結果的缺失資料以SAS PROC MI單調迴歸方式多重插補。
- 理由：採全體隨機分配者的ITT分析（138 vs 140），缺失值以多重插補處理，為估計分配效果的適當分析。
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：可能否（Probably no — 綜合判斷後傾向「否」）
- 原文引述：Among the 278 randomly assigned participants, 228 (82%) completed outcome measurements at week 16. ... A total of 50 (18%) patients dropped out of the study (21 in the acupuncture group and 29 in the sham acupuncture group; 49 during the 4-week treatment and 1 during the 12-week follow-up).278位隨機分配者中，228位（82%）完成第16週結果測量……共50位（18%）退出研究（針灸組21位、假針灸組29位；49位於4週治療期間退出、1位於12週追蹤期間退出）。
- 理由：整體約18%退出，第4週主要終點前針灸組與假針灸組已有相當數量未完成（多數退出發生於4週治療期間），資料並非全部或近乎全部可得。
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：可能是（Probably yes — 綜合判斷後傾向「是」）
- 原文引述：Missing data on the primary outcomes were multiply imputed using the monotone regression option in SAS PROC MI ... Robustness of results to the missing data assumptions was examined via pattern mixture model sensitivity analyses (detailed in Supplement 2).主要結果的缺失資料以SAS PROC MI單調迴歸多重插補……並以型態混合模型敏感度分析檢驗結果對缺失資料假設的穩健性（詳見補充材料2）。
- 理由：主要終點以多重插補處理缺失值，並以型態混合模型敏感度分析驗證穩健性，顯示結果不太可能因缺失資料而產生偏誤。
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：否（No — 有明確證據支持）
- 原文引述：The response rate was based on the overall treatment effect questionnaire, which asked, "How were your gastric symptoms during the past week in comparison with the baseline period?" This was scored on a 7-point Likert scale ... Patients were considered responders if they answered "extremely improved" or "improved".有效率依整體治療效果問卷，詢問「過去一週您的胃部症狀與基線期相比如何？」，以7點Likert量表評分……答『極度改善』或『改善』者視為有效。
- 理由：以標準化7點Likert量表的患者整體評估界定有效率，對此症狀類結果而言為適當的測量方法。
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：否（No — 有明確證據支持）
- 原文引述：Patients, outcome assessors, and statistical analysts were blinded to group assignment.患者、結果評估者與統計分析者均對分組盲化。
- 理由：結果測量方法兩組一致（同一問卷與量表），無證據顯示測量或確認方式因組別而異。
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, outcome assessors, and statistical analysts were blinded to group assignment. ... no difference was found between groups in the proportion of patients who guessed that they received acupuncture at the first and sixth sessions (P = 0.72 and 0.69).患者、結果評估者與統計分析者均對分組盲化……兩組患者猜測接受真針灸的比例無差異（P=0.72、0.69）。
- 理由：本結果為患者自評，結果評估者與患者本人皆盲化、且盲化檢測顯示成功，評估者（含患者自身）不知所接受的介入。
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：The study protocol and statistical analysis plan are presented in Supplement 1 (available at Annals.org). ... (ISRCTN registry number: ISRCTN12511434). ... This trial had 2 primary outcomes: the response rate and the elimination rate after 4 weeks of treatment.研究計畫書與統計分析計畫見補充材料1（Annals.org），試驗於ISRCTN登記（ISRCTN12511434）。本試驗有2個主要結果：4週治療後的有效率與消除率。
- 理由：試驗已登記且提供事前的研究計畫書與統計分析計畫，主要終點（第4週有效率）與分析方法事先界定，研判分析依事前計畫進行。
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：This trial had 2 primary outcomes: the response rate and the elimination rate after 4 weeks of treatment (16). ... The 2 primary outcomes were the response rate based on overall treatment effect and the elimination rate of all 3 cardinal symptoms after 4 weeks of treatment.本試驗有2個主要結果：4週治療後的有效率與消除率。兩個主要結果為依整體治療效果的有效率，及4週治療後3項主要症狀的消除率。
- 理由：有效率為事前明確指定的主要終點、時間點（第4週）與定義（極度改善/改善）皆預先設定，且依計畫報告，無證據顯示係依結果從多個測量中挑選。
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：For primary outcomes, generalized linear mixed models for binary data was used ... Furthermore, a generalized linear model that used estimating equations with an unstructured covariance was fitted to validate the results.主要結果採二元資料的廣義線性混合模型……此外另以未結構化共變異的估計方程式廣義線性模型驗證結果。
- 理由：主要分析方法事先指定且報告其驗證分析（兩法結果一致），無證據顯示係依結果從多個分析中挑選有利者報告。
