Management of Vaginal Complaints: A Pilot Study within

阴道不适的管理：一项试点研究

基本信息

批准号：
7026661
负责人：
Matthew Robert Anderson
金额：
$ 10万
依托单位：
MONTEFIORE MEDICAL CENTER (BRONX, NY)
依托单位国家：
美国
项目类别：
财政年份：
2006
资助国家：
美国
起止时间：
2006-07-01 至 2008-08-31
项目状态：
已结题

项目摘要

DESCRIPTION (Provided by the Applicant): Setting: The study will be carried out at two sites within the New York City Research and Improvement Network (NYC RING) an urban Practice Based Research Network comprising 21 clinical sites. Problem: Vaginal symptoms are the most common reason for outpatient gynecological consultation, yet the management of these symptoms is not well grounded in evidence from primary care. Purpose: To prepare for a randomized clinical trial (RCT) to test whether the current standard of care for evaluating vaginal symptoms (which involves looking for specific pathogens) produces better clinical outcomes than a simpler approach, which treats patients based on their symptoms. Methods: 55 pre-menopausal non-pregnant adult women presenting with vaginal complaints will be randomized into two groups. Women in Group A will be managed on the basis of presenting complaint without physical examination or office laboratory work. Women in Group B will receive a physical examination and office evaluation looking for trichomonads, Candida and bacterial vaginosis. They will be managed according to the clinical and office laboratory findings. Patients will be contacted by phone two weeks after consultation to assess symptom resolution, adverse reaction to drugs, satisfaction with care and treatment experiences. Patients will be screened for infection with gonorrhea and chlamydia using a urine antigen test and for trichomoniasis using vaginal culture. Patients whose tests demonstrate trichomoniasis, chlamydia or gonorrhea or who remain symptomatic at the two-week follow-up call will be re-evaluated promptly. Outcomes: AIM 1: Feasibility. The pilot will assess 1) ability to recruit and retain patients, 2) acceptability of study protocols to subjects and 3) prevalence and detection of important sexually transmitted diseases (STD's). AIM 2: Initial evidence of effectiveness: The pilot will provide data on key planned RCT outcome measurements including 1) treatment success rates (allowing estimation of future sample size), 2) need for re-consultation 3) adverse reactions, 4) medication usage and 5) patient satisfaction. Benefit to public health: This pilot study will lead to a RCT of the management of vaginal complaints in primary care. This RCT may support current practice, reinforcing the need for physical exam and laboratory testing in all patients. On the other hand, the trial may support a more limited approach that avoids a pelvic examination. This could result in substantial savings of health care dollars with equivalent clinical outcomes.

描述（由申请人提供）：设置：该研究将在纽约市研究与改进网络（NYC RING）的两个地点进行，一个基于城市实践的研究网络，包括21个临床站点。问题：阴道症状是门诊妇科咨询的最常见原因，但是这些症状的治疗并不能以初级保健的证据为基础。目的：准备一项随机临床试验（RCT），以测试当前用于评估阴道症状的护理标准（涉及寻找特定病原体）是否会产生更好的临床结局，而不是一种简单的方法，该方法根据患者的症状来治疗患者。方法：55个月经前的非怀孕前成年妇女，出现阴道抱怨的成年妇女将被随机分为两组。 A组中的妇女将根据未经身体检查或办公室实验室工作提出投诉进行管理。 B组中的妇女将接受体格检查和办公室评估，以寻找毛刺，念珠菌和细菌性阴道病。它们将根据临床和办公实验室发现进行管理。咨询后两周将通过电话与患者联系，以评估症状解决，对药物的不利反应，对护理和治疗经验的满意度。使用尿液抗原测试和使用阴道培养物，将对患者筛查患者感染淋病和衣原体。测试的患者表明，在为期两周的随访呼叫中表现出毛瘤，衣原体或淋病或症状的患者将迅速重新评估。结果：目标1：可行性。飞行员将评估1）招募和保留患者的能力，2）研究方案对受试者的可接受性和3）患病率和检测重要的性传播疾病（STD）。目标2：有效性的初始证据：飞行员将提供有关关键计划的RCT结果测量值的数据，包括1）治疗成功率（允许对未来样本量的估计），2）2）需要重新咨询3）3）不良反应，4）4）用药和5）患者满意度。对公共卫生的好处：这项试点研究将导致对初级保健中阴道投诉的管理。该RCT可以支持当前的实践，从而增强了所有患者进行身体检查和实验室检查的需求。另一方面，试验可能支持更有限的方法，以避免骨盆检查。这可能会导致大量节省的保健资金，并具有同等的临床结果。