The Patient Needs in Asthma Treatment (NEAT) Questionnaire: Further Validation and Preparation of its Application in Routine Care

背景：先前的证据表明，在哮喘患者的治疗背景下，存在着主要的未得到满足的需求。满足这些需求可能会改善患者的依从性和健康结果。但前提条件是，患者的需求可以可靠而有效地衡量。由于缺乏这样的工具，我们最近开发了患者对哮喘治疗的需求(NEAT)问卷，并对其有效性进行了初步的了解。目标：虽然对我们的工具的有效性的初步见解是令人鼓舞的，但在它可以被常规部署之前，还需要进行额外的验证工作。特别是，我们现在需要检查进一步的测量属性，包括预测有效性、对变化的响应性、最小临床重要差异(MCID)和重测可靠性。此外，我们的目标是探索在常规患者护理中，患者和医生都能接受的器械管理模式。方法：在四项研究的基础上提出研究目标。研究1将基于为我们先前的研究招募的哮喘患者的3年跟踪调查，这导致了整齐的问卷开发。据估计，将对80%的样本进行随访(n=214)，以检查NEAT仪器的预测有效性(关于已确定的哮喘特异性结果)、对变化的反应性和MCID(例如，使用锚)。对于研究2，我们将招募115名哮喘患者，并在大约4周后对他们进行随访，以检查重测的可靠性。在研究3中，我们将在两个诊所对至少100名住院患者在肺部康复前后使用该仪器，以a)评估由于干预而产生的变化的响应性，以及b)探索医护人员在临床实践中使用我们的工具所取得的经验。最后，在研究4中，我们将探索在常规护理中实施整洁工具的可接受方法的特点。这将通过在患者、医生和潜在的其他相关卫生保健专业人员群体中进行定性研究(焦点小组和深入访谈)来实现。含义：进一步建立整齐问卷的有效性、响应性和可靠性将证明我们的工具对哮喘研究的适用性。在研究中，我们的工具可以用来确定未得到满足的患者需求的分布和决定因素，目的是为干预发展及其评估提供信息。此外，通过探索在常规护理中实施的潜在方法，我们增加了将整洁问卷转移到临床实践并因此可用于临床决策的可能性，例如，促进以患者为中心的哮喘护理的提供。

Background: Prior evidence suggests that major unmet needs exist among asthma patients in the context of their treatment. Addressing those needs may improve the compliance and health outcomes of patients. A prerequisite is though that patient needs can be measured reliably and validly. As such an instrument had been lacking, we have recently developed the Patient Needs in Asthma Treatment (NEAT) questionnaire and gained preliminary insights into its validity. Objectives: While initial insights into the validity of our instrument were encouraging, additional validation work needs to be done before it can be routinely deployed. In particular, we now need to examine further measurement properties, including the predictive validity, responsiveness to change, the minimal clinically important difference (MCID), and test-retest reliability. In addition, we aim to explore what mode of instrument administration in routine patient care would be acceptable to both patient and physicians. Methods: The objectives will be addressed based on a series of four studies. Study 1 will be based on a 3-year follow-up of asthma patients recruited for our prior study which has led to the NEAT questionnaire development. It is estimated that 80% of the sample will be followed-up (n=214) to examine the predictive validity (with regard to established asthma-specific outcomes), responsiveness to change and the MCID (e.g., using anchors) of the NEAT instrument. For Study 2, we will recruit 115 asthma patients and will follow these up after about 4 weeks to examine the test-retest reliability. In Study 3, we will administer the NEAT instrument before and after pulmonary rehabilitation to at least 100 inpatients at two clinics to a) assess the responsiveness to change due to intervention and b) to explore the experiences the health care staff has made with the administration of our tool in clinical practice. Finally, in Study 4 we will explore the characteristics of acceptable approaches to implement the NEAT instrument in routine care. This will be achieved by a qualitative study (focus groups and in-depth interviews) among patients, physicians and potentially other relevant groups of health care professionals. Implications: Further establishment of the validity, responsiveness, and reliability of the NEAT questionnaire will document the suitability of our tool for asthma research. In research, our instrument could be used to identify the distribution and determinants of unmet patient needs with the goal to inform intervention development and their evaluation. Further, by exploring potential approaches to implementation in routine care, we increase the likelihood that the NEAT questionnaire is transferred to clinical practice and thus may be used in clinical decision-making, e.g. to facilitate the delivery of patient-centered asthma care.