Introduction of a clinical guideline to manage type-2 diabetes by ayurvedic practitioners in Nepal: intervention development and feasibility study

糖尿病（2型）是一种复杂的疾病，具有重大的健康，社会和经济后果。尼泊尔的糖尿病负担很高。糖尿病是患者咨询阿育吠陀医生的主要疾病之一。高比例的糖尿病患者使用阿育吠陀治疗，通常从一开始就完全使用，并贯穿其一生。这些方案在农村、穷人、老年人和部落人口中特别受欢迎。阿育吠陀起源于印度次大陆，许多阿育吠陀草药生长在喜马拉雅山脉。阿育吠陀是尼泊尔公认的医疗体系，阿育吠陀从业者是尼泊尔卫生工作者的一部分。尽管在研究环境中发现了几种阿育吠陀药物用于管理糖尿病的有效性和安全性，但仍然强烈关注阿育吠陀临床实践中许多患者的次优糖尿病管理。在糖尿病护理途径的不同阶段采取的行动在很大程度上取决于个体阿育吠陀医生的判断，导致阿育吠陀临床实践中不可接受的变化。许多非循证的阿育吠陀药物是由阿育吠陀从业者开出的，这可能对患者产生严重的不良影响。一个潜在的解决方案可能是引入一个临床指南，该指南将根据现有的最佳证据提出建议。主要目的是确定与通常的阿育吠陀管理相比，引入临床指南是否可以改善阿育吠陀从业者对糖尿病的管理（即，没有任何临床指南）。这将在未来的主要研究中进行测试。在此之前，我们将制定临床指南，并与参与者核实是否可以进行主要研究。我们将遵循标准的临床指南制定过程。认识到许多阿育吠陀成分的科学证据基础并不大（例如，生活方式），我们会从标准西医临床指引中取得类似的证据。将对阿育吠陀药物在糖尿病管理中的有效性和安全性进行系统评价，以生成证据声明。这些声明将提交给一个独立的临床指南制定委员会（涉及一系列利益相关者），以做出最终决定。根据这些决定，将起草并最终确定临床指南。随后，将进行一项研究以检查是否可以完成主要研究。12个拥有阿育吠陀医生的初级卫生中心（PHCs）将被随机分配到基于临床指南的糖尿病管理组或对照组。将招募至少120名新的糖尿病患者，由参与的阿育吠陀医生诊断。将收集并分析研究特定问题的定量数据（数值），例如估计主要研究的研究规模所需的数量、PHC和患者的招募、患者的随访以及阿育吠陀从业者对临床指南的依从性。将对所有12名阿育吠陀从业者和20-30名患者进行定性访谈，以探讨他们如何参与研究以及经历的任何特定问题。我们会与拒绝参与研究的人士会面，以探讨其原因。如果进行主体研究的可行性有希望，我们便会进行主体研究。如果发现有效，糖尿病患者将受益于改善的健康结果，例如更好的血糖控制和更低的糖尿病并发症。患者及其护理人员和家庭未来的相关临床、个人和经济负担将减轻。

Diabetes (type 2) is a complex disorder with major health, social and economic consequences. The burden of diabetes is high in Nepal. Diabetes is one of the top diseases for which patients consult ayurvedic practitioners. A high proportion of diabetes patients use ayurvedic treatments, often from the beginning and exclusively and throughout their lives. These are particularly popular among rural, poor, older and tribal populations. Ayurveda originated in the Indian subcontinent, and many ayurvedic herbs grow in the Himalayan mountains. Ayurveda is a recognised medical system in Nepal, and ayurvedic practitioners are part of the health workforce in Nepal. Despite the effectiveness and safety of several ayurvedic medicines for managing diabetes found in study settings, strong concerns remain about the sub-optimal diabetes management of many patients in ayurvedic clinical practice. The actions to be taken at different stages of the diabetes care pathway are largely left to the judgement of the individual ayurvedic practitioner, resulting in unacceptable variations in ayurvedic clinical practice. Many non-evidence based ayurvedic medicines are prescribed by ayurvedic practitioners, which can have serious adverse effects on patients. A potential solution could be the introduction of a clinical guideline that will make recommendations based on the best available evidence.The main aim is to establish whether the introduction of a clinical guideline can improve the management of diabetes by ayurvedic practitioners as compared to usual ayurvedic management (i.e., without any clinical guideline) in Nepal. This will be tested in a future main study. Before this, we will develop the clinical guideline and will check with our participants if the main study can be conducted. We will follow the standard clinical guideline development process. Recognising that the scientific evidence base is not large for many ayurvedic components (e.g., lifestyle), we will draw similar evidence from the standard western medicine clinical guidelines. A systematic review will be conducted on the effectiveness and safety of ayurvedic medicines in diabetes management, to generate evidence statements. These statements will be presented to an independent clinical guideline development committee (involving a range of stakeholders) for making the final decisions. Based on these decisions, the clinical guideline will be drafted and finalised. Subsequently, a study will be conducted to check if the main study can be done. 12 Primary Health Centres (PHCs) with an ayurvedic practitioner will be randomly allocated either to the clinical guideline-based diabetes management group or the comparator group. At least 120 new diabetes patients, diagnosed by the participating ayurvedic practitioner, will be recruited. Quantitative data (numerical) will be collected and analysed on the study-specific issues, such as quantities that are needed to estimate study size of the main study, recruitment of PHCs and patients, follow-up of patients, and ayurvedic practitioners' adherence to the clinical guideline. Qualitative interviews will take place with all the 12 ayurvedic practitioners and 20-30 patients to explore how they have found taking part in the study and any particular issues experienced. Those who decline to participate in the study will be interviewed to explore the reasons behind.If the feasibility of undertaking the main study is promising, the main study will be conducted. If found to be effective, diabetes patients will benefit from improved health outcomes, such as better blood glucose control and lower diabetes complications. The related future clinical, personal and economic burden on patients and their carers and families will be reduced.