慢性阻塞性肺病患者使用數位健康技術的無實時監督居家復健、醫院復健及常規治療的效果比較：系統性回顧和統合分析與臨床試驗計畫書

Abstract

1. 背景 慢性阻塞性肺病（COPD）是以氣流部分不可逆阻塞為特徵的呼吸系統疾病，是全球第三大死因，每年導致約 300 萬人死亡，影響十分之一的成人。肺復原是 COPD 治療的重要組成部分，能改善運動能力和生活質量。然而，傳統院內肺復原因交通與經濟障礙限制其可行性。數位健康技術（DHT）支持的家庭肺復原克服了這些障礙，提供靈活且可及的選擇。本研究通過系統性綜述與統合分析，探討無即時專業監督條件下，DHT 支持的肺復原對 COPD 患者運動能力和生活質量的影響。研究選用六分鐘步行距離（6MWD）、COPD 評估測試（CAT）及修訂版醫學研究委員會呼吸困難量表（mMRC）作為評估終點，旨在為遠端肺復原的臨床實踐提供實證支持。 2. 方法 本研究系統性回顧符合以下條件的隨機對照試驗：(1) GOLD 標準診斷的 COPD 患者；(2) 使用數位健康技術（DHT）進行無需即時監督的居家肺復原；(3) 比較對象為常規護理（UC）及院內肺復原（HP）；(4) 評估六分鐘步行距離（6MWD）、COPD 評估測試（CAT）及修訂版醫學研究委員會（mMRC）呼吸困難量表。排除非英語文獻、缺乏數據的研究及非原創性研究。數據來源包括 MEDLINE、Scopus 和 EMBASE，檢索日期截至 2024 年 1 月 30 日。 統計分析分為三個階段：(1) 直接比較 DHT vs. UC 和 HP vs. UC，並進一步比較 DHT vs. HP；(2) 根據肺部復健內容（全面性復健 vs. 單一性復健）、介入時間（≤6 個月 vs. >6 個月）及頻率（≤每週 3 次 vs. >每週 3 次）進行亞組分析；(3) 分析復健內容、介入時間與頻率的交互作用對 6MWD 的綜合影響。數據以均值差（MD）及 95% 信賴區間（CI）進行隨機效應模型分析，並通過網絡圖與森林圖展示。所有分析使用 R 語言完成。 3. 結果 本研究系統性回顧與薈萃分析了 21 篇研究，評估數位健康技術（DHT）、院內肺部復健（HP）和常規護理（UC）在慢性阻塞性肺病（COPD）患者中的療效。主要結果顯示，DHT 和 HP 均顯著改善六分鐘步行測試（6MWT）表現，相較於 UC，DHT 的平均差值（MD）為 23.37 米（95% CI：2.91 至 43.82），未超過臨床重要差異（MCID）25 米；HP 的 MD 為 67.81 米（95% CI：46.87 至 88.74），超過 MCID。DHT 與 HP 間的差異（MD：-0.56 米，95% CI：-12.50 至 11.38）未達統計和臨床顯著性，表明兩者效果相近。 亞組分析表明，復健內容（PR Content）、干預持續時間和頻率顯著影響療效。綜合復健內容（Comprehensive PR）的 6MWT 改善（MD：52.23 米，95% CI：45.63 至 58.83）顯著優於單一復健內容（Simple-Focus PR）（MD：6.55 米，95% CI：-0.22 至 13.32）。在持續超過 6 個月的情況下，DHT 的 6MWT 改善（MD：32.24 米，95% CI：4.52 至 59.95）超過 MCID，顯示臨床意義；而在頻率每週 ≤3 次的條件下，HP 的改善幅度（MD：69.77 米，95% CI：27.63 至 111.91）優於 DHT。 雙因素交互分析進一步證實，持續時間與頻率的結合對結果具有重要影響。雙因素交互分析顯示，持續時間超過 6 個月且頻率較高（每週 >3 次）的干預能顯著提升療效，DHT 在此條件下表現出與 HP 相近的效果，凸顯了特定條件下 DHT 的臨床可行性。PR 內容與頻率的交互作用發現，在頻率 ≤3 次/週時，綜合復健內容（Comprehensive PR）無論是 DHT 或 HP，均顯示顯著改善，兩者間無顯著差異。而單一復健內容（Simple-Focus PR）無論頻率高低，皆未顯示統計或臨床顯著改善，進一步強調完整復健內容的重要性。 4. 結論 本系統性回顧與薈萃分析納入了 21 篇研究，探討數位健康技術（DHT）與院內肺部復健（HP）在慢性阻塞性肺病（COPD）患者中的療效。亞組分析顯示，復健內容的多樣性對療效有重要影響。綜合肺部復健（Comprehensive PR）涵蓋多元訓練，如胸部物理治療、肌力訓練、有氧運動和呼吸訓練，顯著提升臨床效果；相較之下，僅專注於步行訓練的簡單肺部復健（Simple-Focus PR）效果有限。頻率與持續時間的分析顯示，HP 在低頻率（每週 ≤3 次）及長期（>6 個月）干預下效果最佳，而 DHT 在高頻率（每週 >3 次）及短期（≤6 個月）干預下更具優勢。DHT 作為靈活的居家復健模式，克服了傳統院內復健的地理與時間限制，對資源受限的患者尤具吸引力。 未來研究應進一步整合綜合復健內容至 DHT 方案中，探索其在真實世界中的應用潛力，以優化肺部復健策略並提升 COPD 患者的生活品質。

Background Chronic Obstructive Pulmonary Disease (COPD) is a leading global cause of mortality, affecting 10% of adults and causing 3 million deaths annually. Pulmonary rehabilitation enhances exercise capacity and quality of life but is often hindered by hospital access barriers. Digital health technology (DHT)-supported home rehabilitation provides a flexible alternative. This systematic review and meta-analysis evaluate the effects of DHT-based rehabilitation, without real-time supervision, on exercise capacity and quality of life in COPD patients, using six-minute walk distance (6MWD), COPD Assessment Test (CAT), and modified Medical Research Council (mMRC) dyspnea scale as endpoints. Method This systematic review included randomized controlled trials (RCTs) of COPD patients diagnosed by GOLD standards, assessing unsupervised home-based pulmonary rehabilitation using digital health technologies (DHT) compared to usual care (UC) or hospital-based pulmonary rehabilitation (HP). Primary outcomes were six-minute walk distance (6MWD), COPD Assessment Test (CAT), and modified Medical Research Council (mMRC) dyspnea scale. Non-English publications, studies lacking data, and non-original research were excluded. Data were retrieved from MEDLINE, Scopus, and EMBASE (cutoff: January 30, 2024). Statistical analysis was conducted in three phases: (1) direct comparisons (DHT vs. UC, HP vs. UC, and DHT vs. HP); (2) subgroup analyses based on pulmonary rehabilitation content (comprehensive vs. simple-focus), intervention duration (≤6 vs. >6 months), and frequency (≤3 vs. >3 times per week); and (3) interaction analyses examining the combined effects of rehabilitation content, duration, and frequency on 6MWD. A random-effects model was applied, with mean differences (MD) and 95% confidence intervals (CI), presented through network diagrams and forest plots. All analyses were performed using R. Result This meta-analysis of 21 studies assessed the effectiveness of Digital Health Technology (DHT) and hospital-based pulmonary rehabilitation (HP) in Chronic Obstructive Pulmonary Disease (COPD). Both interventions significantly improved six-minute walk test (6MWT) performance compared to usual care (UC). DHT showed a mean difference (MD) of 23.37 m (95% CI: 2.91 to 43.82), below the minimal clinically important difference (MCID) of 25 m, while HP achieved 67.81 m (95% CI: 46.87 to 88.74), exceeding the MCID. The difference between DHT and HP (MD: -0.56 m, 95% CI: -12.50 to 11.38) was neither statistically nor clinically significant, indicating comparable efficacy.Subgroup analyses identified pulmonary rehabilitation (PR) content, duration, and frequency as key factors. Comprehensive PR yielded greater improvements (MD: 52.23 m, 95% CI: 45.63 to 58.83) than Simple-Focus PR (MD: 6.55 m, 95% CI: -0.22 to 13.32). DHT demonstrated clinically meaningful gains when lasting >6 months (MD: 32.24 m, 95% CI: 4.52 to 59.95), while HP outperformed DHT at a frequency of ≤3 times per week (MD: 69.77 m, 95% CI: 27.63 to 111.91).Two-factor interaction analysis further confirmed the combined impact of duration and frequency. Interventions >6 months and at >3 times per week significantly improved 6MWT, with DHT achieving outcomes comparable to HP. For Comprehensive PR at ≤3 times per week, both DHT and HP showed significant improvements with no notable difference. In contrast, Simple-Focus PR, regardless of frequency, failed to reach statistical or clinical significance, emphasizing the importance of a structured, multidimensional rehabilitation approach. Conclusion This systematic review and meta-analysis included 21 studies evaluating the effectiveness of Digital Health Technology (DHT) and hospital-based pulmonary rehabilitation (HP) in patients with Chronic Obstructive Pulmonary Disease (COPD). Subgroup analyses highlighted the importance of rehabilitation content in determining outcomes. Comprehensive pulmonary rehabilitation (PR), incorporating chest physiotherapy, strength training, aerobic exercise, and breathing exercises, significantly enhanced clinical benefits, whereas Simple-Focus PR, primarily walking-based, showed limited effectiveness. Analysis of frequency and duration indicated that HP was most effective under low-frequency (≤3 times per week) and long-duration (>6 months) conditions, while DHT demonstrated greater benefits in high-frequency (>3 times per week) and short-duration (≤6 months) interventions. As a flexible home-based rehabilitation approach, DHT addresses geographical and logistical barriers associated with traditional hospital-based programs, making it a viable option for resource-limited patients. Future research should integrate comprehensive rehabilitation content into DHT interventions and assess its real-world applicability to optimize pulmonary rehabilitation strategies and improve the quality of life for COPD patients.