PDF(Pubmed)
Abstract：
Treatments for type 2 diabetes vary widely in their complexity. The simplicity or complexity of a treatment regimen may have an impact on patient preference, treatment adherence, and health outcomes. The purpose of this qualitative study was to develop two draft patient-reported outcome instruments focusing on patients\' experience with simplicity and complexity of treatment for type 2 diabetes.
The instruments were developed in a series of steps: gather information to support development of a concept elicitation interview guide (literature review and expert interviews), concept elicitation interviews with patients (N = 30), cognitive interviews with patients (N = 20), and a translatability assessment.
In concept elicitation interviews, patients with type 2 diabetes reported a range of treatment attributes that influence their perceptions of treatment simplicity and complexity, such as injection devices, medication preparation, dose timing, dose frequency, ease of taking the correct dose, flexibility of dose schedule, remembering to take medication, and food requirements. Two draft questionnaires were developed based on the literature review, expert interviews, and concept elicitation interviews with patients. Revisions were made to these draft instruments based on qualitative interviews with patients and translatability assessment.
The qualitative research conducted in this study supports the content validity of two newly developed instruments, the Simplicity of Diabetes Treatment Questionnaire (Sim-Q) and the Simplicity of Diabetes Treatment Questionnaire-Comparison (Sim-Q-Comp), designed to assess the simplicity and complexity of diabetes treatment from the patient\'s perspective.
Treatments for type 2 diabetes vary widely in their complexity, and previous research suggests that simpler treatments may have benefits for patients, such as better medication adherence and improved glycemic control. Despite the benefits of treatment simplicity, there are limited options for assessing simplicity of treatment from the patient perspective. This study was designed to develop two patient-reported outcome measures that assess simplicity and complexity of treatment for type 2 diabetes. Thirty patients with type 2 diabetes reported a range of treatment attributes that influence their perceptions of treatment simplicity and complexity. These attributes included injection devices, medication preparation, dose timing, dose frequency, ease of taking the correct dose, flexibility of dose schedule, and food requirements. Two questionnaires were developed based on literature review, expert interviews, and patient interviews (one questionnaire for rating a single treatment, and another questionnaire for comparing two treatments). Revisions were made to the draft instruments based on feedback from 20 additional participants and a translatability assessment. The resulting instruments are called the Simplicity of Diabetes Treatment Questionnaire (Sim-Q) and Simplicity of Diabetes Treatment Questionnaire-Comparison (Sim-Q-Comp). Future research with more patients is needed to further examine the psychometric properties of the questionnaires.
The instruments were developed in a series of steps: gather information to support development of a concept elicitation interview guide (literature review and expert interviews), concept elicitation interviews with patients (N = 30), cognitive interviews with patients (N = 20), and a translatability assessment.
In concept elicitation interviews, patients with type 2 diabetes reported a range of treatment attributes that influence their perceptions of treatment simplicity and complexity, such as injection devices, medication preparation, dose timing, dose frequency, ease of taking the correct dose, flexibility of dose schedule, remembering to take medication, and food requirements. Two draft questionnaires were developed based on the literature review, expert interviews, and concept elicitation interviews with patients. Revisions were made to these draft instruments based on qualitative interviews with patients and translatability assessment.
The qualitative research conducted in this study supports the content validity of two newly developed instruments, the Simplicity of Diabetes Treatment Questionnaire (Sim-Q) and the Simplicity of Diabetes Treatment Questionnaire-Comparison (Sim-Q-Comp), designed to assess the simplicity and complexity of diabetes treatment from the patient\'s perspective.
Treatments for type 2 diabetes vary widely in their complexity, and previous research suggests that simpler treatments may have benefits for patients, such as better medication adherence and improved glycemic control. Despite the benefits of treatment simplicity, there are limited options for assessing simplicity of treatment from the patient perspective. This study was designed to develop two patient-reported outcome measures that assess simplicity and complexity of treatment for type 2 diabetes. Thirty patients with type 2 diabetes reported a range of treatment attributes that influence their perceptions of treatment simplicity and complexity. These attributes included injection devices, medication preparation, dose timing, dose frequency, ease of taking the correct dose, flexibility of dose schedule, and food requirements. Two questionnaires were developed based on literature review, expert interviews, and patient interviews (one questionnaire for rating a single treatment, and another questionnaire for comparing two treatments). Revisions were made to the draft instruments based on feedback from 20 additional participants and a translatability assessment. The resulting instruments are called the Simplicity of Diabetes Treatment Questionnaire (Sim-Q) and Simplicity of Diabetes Treatment Questionnaire-Comparison (Sim-Q-Comp). Future research with more patients is needed to further examine the psychometric properties of the questionnaires.
摘要：
背景：2型糖尿病的治疗在其复杂性方面差异很大。治疗方案的简单性或复杂性可能会影响患者的偏好。治疗依从性，和健康结果。这项定性研究的目的是开发两个草稿患者报告的结果工具，重点关注患者在2型糖尿病治疗的简单性和复杂性方面的经验。
方法：工具是通过一系列步骤开发的：收集信息以支持概念启发访谈指南的开发（文献综述和专家访谈），对患者进行概念启发访谈(N=30)，对患者的认知访谈（N=20），和可译性评估。
结果：在概念启发访谈中，2型糖尿病患者报告了一系列影响他们对治疗简单性和复杂性的看法的治疗属性，如注射装置，药物准备,剂量计时,剂量频率,易于服用正确的剂量，剂量计划的灵活性，记得吃药，和食物要求。在文献综述的基础上，编制了两份问卷草案，专家访谈,以及对患者的概念启发访谈。根据对患者的定性访谈和可译性评估，对这些文书草案进行了修订。
结论：本研究中进行的定性研究支持两种新开发的仪器的内容有效性，糖尿病治疗问卷的简单性（Sim-Q）和糖尿病治疗问卷的简单性-比较（Sim-Q-Comp），旨在从患者的角度评估糖尿病治疗的简单性和复杂性。
2型糖尿病的治疗方法在复杂性上差异很大，以前的研究表明，更简单的治疗可能对患者有好处，如更好的药物依从性和改善血糖控制。尽管治疗简单的好处，从患者角度评估治疗简单性的选择有限.这项研究旨在开发两个患者报告的结果指标，以评估2型糖尿病治疗的简单性和复杂性。30名2型糖尿病患者报告了一系列影响他们对治疗简单性和复杂性的看法的治疗属性。这些属性包括注射装置，药物准备,剂量计时,剂量频率,易于服用正确的剂量，剂量计划的灵活性，和食物要求。在文献综述的基础上，编制了两份问卷，专家访谈,和患者访谈(一份评估单一治疗的问卷，和另一份比较两种治疗的问卷)。根据另外20名与会者的反馈和可译性评估，对文书草案进行了修订。所得到的仪器被称为糖尿病治疗问卷的简单性(Sim-Q)和糖尿病治疗问卷-比较的简单性(Sim-Q-Comp)。未来需要对更多患者进行研究，以进一步检查问卷的心理测量特性。
方法：工具是通过一系列步骤开发的：收集信息以支持概念启发访谈指南的开发（文献综述和专家访谈），对患者进行概念启发访谈(N=30)，对患者的认知访谈（N=20），和可译性评估。
结果：在概念启发访谈中，2型糖尿病患者报告了一系列影响他们对治疗简单性和复杂性的看法的治疗属性，如注射装置，药物准备,剂量计时,剂量频率,易于服用正确的剂量，剂量计划的灵活性，记得吃药，和食物要求。在文献综述的基础上，编制了两份问卷草案，专家访谈,以及对患者的概念启发访谈。根据对患者的定性访谈和可译性评估，对这些文书草案进行了修订。
结论：本研究中进行的定性研究支持两种新开发的仪器的内容有效性，糖尿病治疗问卷的简单性（Sim-Q）和糖尿病治疗问卷的简单性-比较（Sim-Q-Comp），旨在从患者的角度评估糖尿病治疗的简单性和复杂性。
2型糖尿病的治疗方法在复杂性上差异很大，以前的研究表明，更简单的治疗可能对患者有好处，如更好的药物依从性和改善血糖控制。尽管治疗简单的好处，从患者角度评估治疗简单性的选择有限.这项研究旨在开发两个患者报告的结果指标，以评估2型糖尿病治疗的简单性和复杂性。30名2型糖尿病患者报告了一系列影响他们对治疗简单性和复杂性的看法的治疗属性。这些属性包括注射装置，药物准备,剂量计时,剂量频率,易于服用正确的剂量，剂量计划的灵活性，和食物要求。在文献综述的基础上，编制了两份问卷，专家访谈,和患者访谈(一份评估单一治疗的问卷，和另一份比较两种治疗的问卷)。根据另外20名与会者的反馈和可译性评估，对文书草案进行了修订。所得到的仪器被称为糖尿病治疗问卷的简单性(Sim-Q)和糖尿病治疗问卷-比较的简单性(Sim-Q-Comp)。未来需要对更多患者进行研究，以进一步检查问卷的心理测量特性。
