Ahmed Anam, Mewes Janne C, Boot Iris W A, Vrijhoef Hubertus J M
Panaxea, Amsterdam, Netherlands.
JMIR Form Res. 2023 Jan 11;7:e36401. doi: 10.2196/36401.
Notwithstanding the benefits of heat and moisture exchangers (HMEs) in both clinical research and practice, a gap exists between the optimal physiological humidification created through the nasal function and the humidification capacity of HMEs for patients after total laryngectomy. In this study, 5 new HMEs (Provox Life) specialized for situational use with improved humidification capacities were evaluated.
This study aims to evaluate the effectiveness of the existing HMEs, assess the potential effectiveness of the new HMEs, and elicit expert judgments on the new HMEs' expected effectiveness and impact on health care use.
First, a rapid literature review (RLR) was performed to identify evidence on the clinical outcomes, health outcomes, and complications of HMEs in patients who underwent laryngectomy. Second, semistructured interviews with German experts (n=4) were conducted to validate the findings of the RLR and identify reasonable expectations regarding the potential of the new HMEs. Third, a structured expert elicitation among German experts (n=19) was used to generate quantitative evidence on the expected effectiveness of the new HMEs in clinical and health outcomes.
The RLR (n=10) demonstrated that HME use by patients has advantages compared with no HME use concerning breathing resistance, tracheal dryness and irritation, mucus production and plugging, frequency of cough and forced expectorations, sleep quality, voice quality, use of physiotherapy, tracheobronchitis or pneumonia episodes, quality of life, and patient satisfaction. From the expert interviews and structured expert elicitation, it was found that, on average, experts expect that compared with the second-generation HMEs, the new HMEs will lead to a decrease in tracheal dryness or irritation (51%, SD 24%, of patients), mucus plug events (33%, SD 32%, of patients), mucus production (53%, SD 22%, of patients), physiotherapy (0.74, SD 0.70, days) and pulmonary infections (34%, SD 32%) and an increase or improvement in speech quality (25%, SD 23%, of patients), social contacts (13%, SD 18%), quality of life (33%, SD 30%), and patient satisfaction (44%, SD 30%). An improvement in breathing (53%, SD 28%, of patients) and shortness of breath (48%, SD 25%, of patients) was expected. The average number of daily cough periods and forced expectorations was expected to be 2.95 (SD 1.61) and 2.46 (SD 1.42), respectively. Experts expect that, on average, less than half of the patients will experience sleeping problems (48%, SD 22%) and psychosocial problems (24%, SD 20%).
According to German experts, it is expected that the new HMEs with improved humidification levels will lead to additional (clinical) effectiveness on pulmonary health and an improved overall quality of life of patients compared with the currently available HMEs.
尽管热湿交换器（HMEs）在临床研究和实践中都有诸多益处，但全喉切除术后患者通过鼻腔功能实现的最佳生理加湿与HMEs的加湿能力之间仍存在差距。在本研究中，对5种专为特定情况使用且加湿能力有所改进的新型HMEs（Provox Life）进行了评估。
本研究旨在评估现有HMEs的有效性，评估新型HMEs的潜在有效性，并征求专家对新型HMEs预期有效性及其对医疗保健使用影响的判断。
首先，进行了快速文献综述（RLR），以确定有关接受喉切除术患者使用HMEs的临床结局、健康结局和并发症的证据。其次，对德国专家（n = 4）进行了半结构化访谈，以验证RLR的结果，并确定对新型HMEs潜力的合理期望。第三，对德国专家（n = 19）进行了结构化专家意见征集，以生成关于新型HMEs在临床和健康结局方面预期有效性的定量证据。
快速文献综述（n = 10）表明，与不使用HMEs相比，患者使用HMEs在呼吸阻力、气管干燥和刺激、黏液产生和堵塞、咳嗽和用力咳痰频率、睡眠质量、声音质量、物理治疗使用、气管支气管炎或肺炎发作、生活质量以及患者满意度等方面具有优势。从专家访谈和结构化专家意见征集中发现，平均而言，专家预计与第二代HMEs相比，新型HMEs将使气管干燥或刺激减少（51%的患者，标准差24%）、黏液堵塞事件减少（33%的患者，标准差32%）、黏液产生减少（53%的患者，标准差22%）、物理治疗减少（0.74天，标准差0.70）以及肺部感染减少（34%，标准差32%），并使语音质量提高或改善（25%的患者，标准差23%）、社交接触增加（13%，标准差18%）、生活质量提高（33%，标准差30%）以及患者满意度提高（44%，标准差30%）。预计呼吸改善（53%的患者，标准差28%）和气促改善（48%的患者，标准差25%）。预计每日平均咳嗽次数和用力咳痰次数分别为2.95次（标准差1.61）和2.46次（标准差1.42）。专家预计，平均而言，不到一半的患者会出现睡眠问题（48%，标准差22%）和心理社会问题（24%，标准差20%）。
根据德国专家的意见，预计加湿水平得到改进的新型HMEs与目前可用的HMEs相比，将在肺部健康方面带来额外的（临床）有效性，并改善患者的整体生活质量。
