Acupuncture for Symptom Management in Veterans with Hepatitis C

描述(由申请人提供)： 拟议的混合方法试点研究的主要目的是描述两组患有丙型肝炎(丙型肝炎)的退伍军人的经历：(1)患有丙型肝炎但未接受抗病毒治疗的退伍军人和(2)患有丙型肝炎并正在接受抗病毒治疗的退伍军人。另一个目的是确定8周针灸计划在处理两组共同经历的症状方面的可接受性和可行性。这项初步研究将使我们能够计算出全面试验的样本量。我们还将确定针灸疗法是否有足够的益处，以保证通过随机对照试验进行进一步研究。本研究将采用定性和定量相结合的前瞻性描述性纵向设计。对于这项研究来说，混合方法是合理的，因为这两种方法是相辅相成的，结合使用定量和定性数据可以更深入地了解使用针灸来管理丙型肝炎病毒感染者和丙型肝炎病毒感染者在抗病毒治疗中常见症状的可接受性和可行性。研究目的1：用定性的方法描述(1)未接受抗病毒治疗的丙型肝炎病毒感染者和(2)正在接受抗病毒治疗的丙型肝炎病毒感染者接受针灸治疗症状管理的经验。研究目的2：探讨和描述针灸疗法在(1)未接受抗病毒治疗的丙型肝炎病毒感染者和(2)正在接受抗病毒治疗的丙型肝炎病毒感染者中用于症状管理的可接受性和可行性。研究目标3：探索和描述(1)未接受抗病毒治疗的丙型肝炎病毒感染者和(2)正在接受抗病毒治疗的丙型肝炎病毒感染者的针灸后症状(抑郁、疼痛和疲劳)随时间的变化。项目方法：方便性样本包括20名丙型肝炎病毒感染者和20名正在接受抗病毒治疗的退伍军人。使用简明疲劳量表(C)(BFI)、视觉模拟疼痛评定量表(VAS 100)、流行病学研究中心抑郁量表(CES-D)、记忆症状评定量表(MSAS-SF)和VR-36获得定量数据。将在12周内收集20名丙型肝炎病毒感染者和20名丙型肝炎病毒感染者接受抗病毒治疗的数据。定性数据将从更大的定量样本的子集中收集。个人将参加每周两次的针灸治疗，总共8周。针灸将在小组环境中进行。结果将在基线、第2、4、6、8周收集，参与者将在最后一次针灸治疗后第1周和第2周完成一份问卷。定性数据将从较大数量样本的个体子集中收集。总共将采访8-10名丙型肝炎病毒感染者和8-10名正在接受抗病毒治疗的丙型肝炎病毒感染者。第一次访谈将在第一次针灸治疗之前进行，第二次访谈将在针灸干预的第6至8周之间进行。作为我们评估针灸治疗丙型肝炎患者症状可行性的一部分，我们将测量治疗依从性(针灸)。将为两个研究小组中的每一个获得这些信息。定性数据将使用内容分析进行分析。

DESCRIPTION (provided by applicant): The primary aim of the proposed mixed method pilot study is to describe the experience of two groups of Veterans with hepatitis C (HCV): (1) Veterans that have HCV, but who are not undergoing antiviral treatment and (2) Veterans that have HCV and who are receiving antiviral treatment. An additional aim is to determine the acceptability and feasibility of an 8 week acupuncture program in managing symptoms commonly experienced by both groups. This pilot study will allow us to calculate a sample size for a full-scale trial. We will also establish whether there is sufficient benefit from acupuncture therapy to warrant further study with a randomized control trial. The study will use a prospective descriptive longitudinal design using qualitative and quantitative methods. Mixed methods are justified for this study because the two methods complement each other and the combined use of quantitative and qualitative data allows for a more in-depth understanding of the acceptability and feasibility of using acupuncture to manage the symptoms commonly experienced by individuals with HCV and individuals with HCV on antiviral therapy. Research Aim #1: To describe, using qualitative methods, the experience of undergoing acupuncture therapy for symptom management in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Research Aim #2: To explore and describe the acceptability and feasibility of acupuncture therapy for symptom management in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Research Aim #3: To explore and describe symptom (depression, pain, and fatigue) changes over time following acupuncture in (1) Veterans with HCV and who are not receiving antiviral therapy and (2) Veterans with HCV who are receiving antiviral therapy. Project Methods: The convenience sample will include 20 veterans with HCV and 20 veterans with HCV undergoing antiviral therapy. Quantitative data will be obtained using the Brief Fatigue Inventory(c) (BFI), Visual Analogue Pain Scale (VAS 100), Center for Epidemiological Studies Depression Scale (CES-D), Memorial Symptom Assessment Scale- short form (MSAS-SF) and VR-36. Data will be collected over a period of 12 weeks from 20 individuals with HCV and 20 individuals with HCV undergoing antiviral therapy. Qualitative data will be collected from a subset of the larger quantitative sample. Individuals will attend two acupuncture sessions each week for a total of 8 weeks. The acupuncture will be administered in a group setting. Outcomes will be collected at baseline, weeks 2, 4, 6, 8, and participants will complete a questionnaire packet at weeks 1 and 2 after the final acupuncture session. Qualitative data will be collected from a subset of individuals of the larger quantitative sample. A total of 8-10 individuals with HCV and 8-10 individuals with HCV undergoing antiviral therapy will be interviewed. The first interview will take place before the first acupuncture session and the second between week 6 and 8 of the acupuncture intervention. As part of our assessment of the feasibility of acupuncture therapy for symptoms in HCV patients, we will measure compliance with treatment (acupuncture). These will be obtained for each of the two study groups. Qualitative data will be analyzed using content analysis.