VALIDATION OF A DISEASE SPECIFIC HEALTH STATUS INSTRUMEN

在20世纪60年代，S意识到，许多择期扁桃体切除术是 可能没有必要，而且在美国演出的人数 急剧减少--从1959年的140万人减少到1979年的40万人。 然而，扁桃体切除术曾经是最常见的手术之一。 对儿童进行的手术，并负责显著的 医疗保健支出(每年超过8亿美元 美国)。今天，许多腺体扁桃体切除术的适应症仍然存在。 定义不明确且有争议，并且存在显著差异 不同地区扁桃体摘除术的发生率 地区。一些情况，如睡眠呼吸暂停，似乎在治疗后有所改善 腺扁桃体切除术，而其他，如复发感染，可能会显示 与警惕的等待或医疗相比，只有短期的好处 心理治疗。没有研究评估扁桃体和腺样体(T)的影响 和a)疾病对患者的健康状况或生活质量(QOL)的影响 孩子们。 在进行前瞻性临床试验之前， 手术和内科治疗的适当性和有效性，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疾病的自然病史。因此，这一目标是 研究就是要创造一个有效、可靠、敏感、全面的 保健服务中使用的疾病特定健康状况测定仪 儿童T-A病的研究进展就像在其他儿科健康中一样 状态仪器，T和A仪器将由 受影响孩子的父母。 我们提出了一项分三个阶段进行的前瞻性工具验证研究。 阶段1(焦点小组、项目开发、初始项目测试和 减少，并开发测试版)已经完成 作为一项先导研究。在第二阶段，我们将评估重测和 内部一致性信度、结构效度和效标效度 对该工具的测试版的组间歧视-- 使用现有的通用工具、客观的临床措施和 对照组为非T、A类疾病患者。此操作的第三阶段 研究将评估仪器对变化的敏感性 临床状态。我们期待着T和A的验证 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.