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Independent Hospital and Healthcare Professional, Ghent, Belgium.
Patient. 2019 Oct;12(5):527-537. doi: 10.1007/s40271-019-00369-8.
Clinical outcome assessments may not fully capture patients' perspectives of treatment benefit or tolerability. Incorporating individual exit interviews might enhance the description of the patient experience of drug effects.
The objective of this study was to evaluate the patient treatment experience in a clinical trial of treatment-resistant depression utilizing exit interview methodology.
Individual patient interviews were conducted with subjects exiting two phase II clinical trials involving investigational agents for treatment-resistant depression. Interviews included standardized questions about patients' perceptions of health changes and interest in continued use of the investigational agent. Constant comparative analysis of blinded data was used to identify, code, and categorize the data followed by a subsequent analysis of unblinded data to evaluate any potential treatment differences.
Ninety subjects completed exit interviews across the two trials. Most subjects (90%, Trial 2001; 74%, Trial 2002) reported at least one health change. Most subjects rated these changes to be at least moderately important, with most being rated "very important" to "extremely important." After unblinding, participants receiving active therapy alone reported most of the positive health changes (80% of overall positive changes in Trial 2001, 89% in Trial 2002), whereas patients taking placebo alone reported the majority of negative health changes (57% in Trial 2002). Positive changes included not only anticipated changes in mood but also potential cognitive benefits such as mental alertness, improved sleep, and better concentration.
Standardized interview data provided direct patient insight into the treatment experience from the patient perspective. Data from these interviews assisted in phase III endpoint selection by providing data on relevant concepts in the target treatment-resistant depression population receiving a new treatment, thus enabling the selection of tools to capture noted treatment effects and, by eliminating irrelevant constructs or measures, thereby reducing data "noise."
ClinicalTrials.gov NCT01640080; NCT01627782.
临床疗效评估可能无法充分体现患者对治疗获益或耐受性的看法。纳入个体退出访谈可能会增强对药物效应患者体验的描述。
本研究旨在利用退出访谈方法评估治疗抵抗性抑郁症临床试验中患者的治疗体验。
对参与两项涉及治疗抵抗性抑郁症研究性药物的 II 期临床试验的受试者进行个体患者访谈。访谈包括关于患者对健康变化的看法和对继续使用研究性药物的兴趣的标准化问题。使用盲法数据的恒定比较分析来识别、编码和分类数据，然后对未盲数据进行后续分析，以评估任何潜在的治疗差异。
两项试验共 90 名受试者完成了退出访谈。大多数受试者（90%，试验 2001；74%，试验 2002）报告至少有一项健康变化。大多数受试者认为这些变化至少是中度重要的，大多数被评为“非常重要”到“极其重要”。在解除盲法后，单独接受活性治疗的参与者报告了大多数阳性健康变化（试验 2001 中总体阳性变化的 80%，试验 2002 中 89%），而单独服用安慰剂的患者报告了大多数负面健康变化（试验 2002 中 57%）。阳性变化不仅包括预期的情绪变化，还包括潜在的认知益处，如精神警觉、改善睡眠和更好的注意力。
标准化访谈数据从患者角度直接提供了对治疗体验的患者见解。这些访谈数据通过提供新治疗方案的目标治疗抵抗性抑郁症人群中相关概念的数据，协助了 III 期终点选择，从而选择了能够捕捉到已注意到的治疗效果的工具，并通过消除不相关的结构或措施，从而减少数据“噪音”。
ClinicalTrials.gov NCT01640080；NCT01627782。
