Comparative Effectiveness of Field-Treatments for Multiple Actinic

多种光化剂现场处理的比较效果

基本信息

批准号：
8603196
负责人：
MARYAM Mandana ASGARI
金额：
$ 7.9万
依托单位：
KAISER FOUNDATION RESEARCH INSTITUTE
依托单位国家：
美国
项目类别：
财政年份：
2013
资助国家：
美国
起止时间：
2013-01-10 至 2015-12-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8603196
关键词：
Ablation Accounting Actinic keratosis Affect Ambulatory Care American Americas Anatomy Apoptosis Basal cell carcinoma California Caring Cells Clinic Clinical Clinical Markers Clinical Research Clinical Trials Cohort Studies Cold Therapy Combined Modality Therapy Comorbidity Confounding Factors (Epidemiology)Curettage procedure Cutaneous Precancerous Condition Data Databases Diagnosis Direct Costs Dose Drug Exposure Dysplasia Economic Burden Effectiveness Electronics Environment Epidemiology Facilities and Administrative Costs Fluorouracil Future Goals Growth Guidelines Healthcare Healthcare Systems Imiquimod Immune response Incidence Individual Knowledge Lesion Life Malignant Neoplasms Medicare Methodology Methods Office Visits Outcome Pathology Report Patients Pharmaceutical Preparations Pharmacy facility Population Premalignant Prevention Procedures Provider Randomized Controlled Trials Records Regimen Reporting Risk Skin Skin Cancer Skin Carcinoma Structural Models System The Sun Topical agent Visit base burden of illness cancer diagnosis cancer risk comparative effectiveness compare effectiveness cost cytotoxic follow-up health care delivery high risk immune function neglect neoplasm registry novel prevent primary outcome public health relevance response secondary outcome skin disorder skin squamous cell carcinoma standard of care

项目摘要

DESCRIPTION (provided by applicant): Non-melanoma skin cancer (NMSCs) is the most common cancer in America, with over 2 million cases diagnosed annually. Despite the large population affected and resultant burden of disease, no effective chemopreventative strategies have been identified, especially among sun-damaged individuals with existing precancerous skin lesions who are at high risk of developing skin cancer. Actinic keratoses (AKs) are precancerous skin lesions that arise on sun-damaged skin and can progress to NMSCs. The two most widely used topical agents for the treatment of multiple AKs are 5- fluorouracil (5-FU) and imiquimod. Although visits for AKs accounts for over 3.7 million ambulatory care office visits per year in the US and their treatment poses a substantial financial burden to our healthcare system, costing over a billion dollars annually, no studies have compared the effectiveness of the these twp topical field-based therapies. We propose to compare the effectiveness of 5-FU and imiquimod in preventing NMSCs (primary aim) and AKs (secondary aim) using retrospective data from Kaiser Permanente Northern California (KPNC). We also seek to ascertain dose-response curves for each drug over a 5 year follow-up period. One of the unique features of the project is the setting, which allows for ascertainment of effectiveness in a real-world practice environment. KPNC also offers the added advantage of rich electronic databases, with a wealth of information of exposure (detailed pharmacy database), outcome (unique NMSC registry which identified non-reportable skin cancer), and potentially relevant co-variates. The other unique aspect of this proposal is the way in which the retrospective observational data is approached, utilizing novel biostatistical methodologies (point-treatment marginal structural models) to draw casual inference regarding the relationship between exposure and outcome as would be obtained in a clinical trial setting. These newly developed methods have not been previously used in Dermato-epidemiology. The goals of this project align with NIAMS's long-range planning goals of increasing skin related clinical research by performing "comparative effectiveness of therapies, and combination therapy approaches for skin disease treatment." By accomplishing our study aims, we can help identify the most effective topical agent among high risk individuals for the prevention of the most common cancer in America.

描述（由申请人提供）：非黑色素瘤皮肤癌 (NMSC) 是美国最常见的癌症，每年诊断出超过 200 万例。尽管受影响人口众多并造成疾病负担，但尚未确定有效的化学预防策略，特别是对于患有癌前皮肤病变且患有皮肤癌的高风险的晒伤个体。光化性角化病 (AK) 是一种癌前皮肤病变，出现在阳光损伤的皮肤上，可进展为 NMSC。用于治疗多种 AK 的两种最广泛使用的外用药物是 5-氟尿嘧啶 (5-FU) 和咪喹莫特。尽管美国每年有超过 370 万人次到门诊就诊 AK，而且其治疗给我们的医疗保健系统带来了巨大的经济负担，每年花费超过 10 亿美元，但没有研究比较这些 twp 主题领域的有效性为基础的疗法。我们建议使用北加州凯撒医疗机构 (KPNC) 的回顾性数据来比较 5-FU 和咪喹莫特在预防 NMSC（主要目标）和 AK（次要目标）方面的有效性。我们还寻求确定每种药物在 5 年随访期内的剂量反应曲线。该项目的独特之处之一是其设置，可以在现实世界的实践环境中确定有效性。 KPNC 还提供了丰富的电子数据库的额外优势，其中包含大量的暴露信息（详细的药房数据库）、结果（识别不可报告皮肤癌的独特 NMSC 注册表）以及潜在相关的协变量。该提案的另一个独特之处是处理回顾性观察数据的方式，利用新颖的生物统计方法（点治疗边际结构模型）对临床试验中获得的暴露与结果之间的关系进行随意推论环境。这些新开发的方法以前从未用于皮肤流行病学。该项目的目标与 NIAMS 的长期规划目标一致，即通过“比较疗效的疗法和皮肤病治疗的联合疗法”来增加皮肤相关的临床研究。通过实现我们的研究目标，我们可以帮助在高危人群中确定最有效的外用药物，以预防美国最常见的癌症。