Symptom measurement in the Breast Cancer Prevention Trial (BCPT) (P-1): psychometric properties of a new measure of symptoms for midlife women
Symptom measurement in the Breast Cancer Prevention Trial (BCPT) (P-1): psychometric properties of a new measure of symptoms for midlife women
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DOI：
10.1007/s10549-007-9682-9
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发表时间：
2008-06-01
影响因子：
3.8
通讯作者：
Ganz, Patricia A.
中科院分区：
文献类型：
--
作者：
Cella, David;Land, Stephanie R.;Ganz, Patricia A.
目的：为了评估妇女参加乳腺癌预防试验（BCPT）（P-1）的国家外科辅助乳腺和肠道项目（NSABP）进行的症状量表管理的可扩展性和方法：11,064名妇女招募到一项研究，20毫克每日他莫昔芬与安慰剂，以防止乳腺癌的高危妇女的反应进行了分析。对4,000名妇女的随机子集进行了12个月数据的探索性因素分析，以估计因素结构。对这4,000名妇女的基线数据进行了分析，以确认结构。剩余的样本被随机分为两个数据集。然后将每组数据按年龄（35-49岁、50-59岁或≥ 60岁）和治疗（他莫昔芬或安慰剂）分组，以证实这些分析。获得的症状群和两个标准工具（SF-36和CES-D）之间的相关性进行了检查。内容分析的开放式的回应也carried.Results：八个临床解释集群的症状被确定和确认：认知症状，肌肉骨骼疼痛，血管痉挛症状，恶心，性问题，膀胱问题，身体形象，阴道症状。提供了这八个聚类所代表的每个量表的评分。开放式回答的内容分析表明，有四个项目是额外的候选人：疲劳，背部问题，腹痛，腿/脚抽筋或疼痛。结论：与乳腺癌激素治疗相关的症状可能不同。然而，BCPT八项症状量表（BESS）可以聚类为临床相关和可重复的因素，可能是有用的，在未来的结果研究。
Purpose: To evaluate scalability of a symptom scale administered to women enrolled in the Breast Cancer Prevention Trial (BCPT) (P-1) conducted by the National Surgical Adjuvant Breast and Bowel Project (NSABP).Patients and methods: Responses of 11,064 women recruited into a study of 20 mg daily tamoxifen versus placebo to prevent breast cancer in high-risk women were analyzed. Exploratory factor analyses of the 12 month data were conducted on a random subset of 4,000 women to estimate the factor structure. Baseline data on these same 4,000 women were analyzed to confirm the structure. The remaining sample was divided randomly into two data sets. Data on each set were then grouped by age (35-49, 50-59, or >= 60 years) and treatment (tamoxifen or placebo) to corroborate these analyses. Correlations between the obtained symptom clusters and two standard instruments (SF-36 and CES-D) were examined. Content analysis of open-ended responses was also conducted.Results: Eight clinically-interpretable clusters of symptoms were identified and confirmed: Cognitive symptoms, musculoskeletal pain, vasomotor symptoms, nausea, sexual problems, bladder problems, body image, and vaginal symptoms. Scoring for each scale represented by these eight clusters is provided. Content analysis of open-ended responses suggested four items that are additional candidates: fatigue, back problems, abdominal pain, and leg/foot cramps or pain. Conclusions: Symptoms associated with hormone therapy for breast cancer can vary. Nevertheless, the BCPT Eight Symptom Scale (BESS) can be clustered into clinically relevant and reproducible factors that may be useful in future outcomes research.