Revicki D A, Sorensen S, Wu A W
MEDTAP International, Bethesda, MD 20814, USA.
Med Care. 1998 Feb;36(2):126-37. doi: 10.1097/00005650-199802000-00003.
Health-related quality of life measures are used to evaluate patient outcomes in clinical trials of new treatments for human immunodeficiency virus (HIV)/acquired immunodeficiency syndrome (AIDS). Summary index scores, rather than profiles of scale scores, would simplify data analysis and interpretation of findings from clinical trials and comparison across studies.
Baseline MOS HIV Health Survey scores from two clinical trials of new antiretroviral medications in HIV/AIDS patients (total n = 2253) and an observational study (n = 162) were used to develop physical health summary (PHS) and mental health summary (MHS) scores. Exploratory and confirmatory factor analysis were used to identify the factor structure of the summary scores based on MOS HIV Health Survey scales. Physical health summary and MHS scores were derived and the factor structure proved invariant across the two groups.
Reliability of the PHS score was 0.90 to 0.92 and MHS score was 0.91 to 0.94. Mean PHS and MHS scores differed in patient groups defined by HIV disease stage, HIV disease severity, Karnofsky performance status scores, and global ratings of health status. Mean PHS and MHS scores in patient reporting worsening health status were significantly lower than scores of patients reporting stable or improving health status.
The PHS and MHS were reproducible across different samples of HIV/AIDS patients and are reliable and valid measures for demonstrating treatment impact on patient functioning and well-being.
在人类免疫缺陷病毒(HIV)/获得性免疫缺陷综合征(AIDS)新疗法的临床试验中,与健康相关的生活质量测量指标用于评估患者的治疗结果。汇总指数得分而非量表得分概况,将简化临床试验数据分析和结果解读以及不同研究间的比较。
来自两项HIV/AIDS患者新抗逆转录病毒药物临床试验(总计n = 2253)和一项观察性研究(n = 162)的基线MOS HIV健康调查得分,用于制定身体健康汇总(PHS)和心理健康汇总(MHS)得分。探索性和验证性因素分析用于根据MOS HIV健康调查量表确定汇总得分的因素结构。得出了身体健康汇总得分和MHS得分,且两组间因素结构被证明具有不变性。
PHS得分的信度为0.90至0.92,MHS得分的信度为0.91至0.94。在根据HIV疾病阶段、HIV疾病严重程度、卡诺夫斯基功能状态评分和总体健康状况评定所定义的患者组中,PHS和MHS的平均得分有所不同。报告健康状况恶化的患者的PHS和MHS平均得分显著低于报告健康状况稳定或改善的患者的得分。
PHS和MHS在不同的HIV/AIDS患者样本中具有可重复性,是证明治疗对患者功能和幸福感影响的可靠且有效的测量指标。