VALIDATION OF A DISEASE SPECIFIC HEALTH STATUS INSTRUMEN

在20世纪60年代，人们意识到许多选择性扁桃体切除术 可能是不必要的，在美国进行的数量 从1959年的140万人急剧下降到1979年的40万人。 然而，腺样体切除术仍然是最常见的外科手术之一， 对儿童进行的手术，并负责重大 医疗保健支出（每年超过8亿美元， 美国）。 今天，许多腺样体切除术的适应症仍然是 定义不明确和有争议，存在重大差异， 不同地区扁桃体切除率 地区一些情况，如睡眠呼吸暂停，似乎改善后， 腺样体切除术，而其他，如复发性感染，可能会显示， 与观察等待或医疗相比， 疗法 没有研究评价扁桃体和腺样体（T 和A）疾病对受影响的健康状况或生活质量（QOL）的影响 孩子 在进行前瞻性临床试验以比较 适当和有效的手术和药物治疗，我们 需要客观地衡量特定疾病的健康状况， 受影响的儿童。 此外，还需要进一步的研究来确定 T和A疾病的自然史。 因此，这一目标 研究是为了创造一个有效的，可靠的，敏感的，全面的 用于保健服务的特定疾病健康状况工具 儿童T和A疾病的研究。 与其他儿科健康 测试和评估文书将由 受影响孩子的父母。 我们提出了一个前瞻性的仪器验证研究分三个阶段。 第1阶段（焦点小组、项目开发、初始项目测试和 减少和开发测试版）的工作已经完成 作为试点研究。 在第二阶段，我们将评估重测， 内部一致性信度、结构效度和效标效度，以及 测试版工具的群体间歧视- 使用现有的通用工具，客观的临床措施， 对照组为无T和A病的患者。 第三阶段 研究将评估仪器对以下变化的敏感性： 临床状态 我们预计T和A的有效性 仪器将在24个月内完成。

In the 1960's it was realized that many elective tonsillectomies were probably unnecessary and the number performed in the United States decreased dramatically - from 1,400,000 in 1959 to 400,000 in 1979. However, adenotonsillectomy remains once of the most common surgical procedures performed on children, and is responsible for significant health care expenditures (over 800 million dollars annually in the U.S.). Today, many of the indications for adenotonsillectomy are still poorly defined and controversial, and significant variation exists in the rate of adenotonsillectomy performed in different geographic regions. Some conditions, such as sleep apnea, appear to improve after adenotonsillectomy whereas others, such as recurrent infection, may show only short-term benefit compared with watchful waiting or medical therapy. No studies have evaluated the impact of tonsil and adenoid (T and A) disease on the health status or quality of life (QOL) of affected children. Before prospective clinical trials can be carried out to compare the appropriateness and effectiveness of surgical and medical treatment, we need to objectively measure the disease-specific health status of affected children. In addition, further research is needed to define the natural history of T and A disease. Therefore, the goal of this research is to create a valid, reliable, sensitive, and comprehensive disease-specific health status instrument for use in health services research on pediatric T and A disease. As in other pediatric health status instruments, the T and A instrument will be completed by the parent of the affected child. We propose a prospective instrument validation study in three phases. Phase 1 (focus groups, item development, initial item testing and reduction, and development of a beta-version) has already been completed as a pilot study. In phase 2, we will assess the test-retest and internal consistency reliability, construct and criterion validity, and between-groups discrimination of the beta-version of the instrument - using existing generic instruments, objective clinical measures, and a control group of patients without T and A disease. Phase 3 of this study will assess the sensitivity of the instrument to change in clinical status. We anticipate that validation of the T and A instrument will be completed in 24 months.