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血液透析治疗后的恢复时间:一个简单的与健康相关的生活质量问题,该问题可靠、有效且对变化敏感。

Minutes to recovery after a hemodialysis session: a simple health-related quality of life question that is reliable, valid, and sensitive to change.

作者信息

Lindsay Robert M, Heidenheim Paul A, Nesrallah Gihad, Garg Amit X, Suri Rita

机构信息

Division of Nephrology and Optimal Dialysis Research Unit, University of Western Ontario, London, Ontario, Canada.

出版信息

Clin J Am Soc Nephrol. 2006 Sep;1(5):952-9. doi: 10.2215/CJN.00040106. Epub 2006 Jul 6.

Abstract

Patients who have end-stage renal failure and are treated by hemodialysis (HD) face a stressful chronic illness with a demanding treatment regimen that affects quality of life. Quality-of-life domains can be measured by assessment questionnaires that are easy to complete, reliable, valid, and sensitive to change. There is current interest in HD regimens that provide more frequent treatments (e.g., daily) than the conventional thrice weekly. Improvement in quality of life by these regimens has been reported. A published prospective, cohort, controlled study (London Daily/Nocturnal Hemodialysis Study) included the results of a number of quality-of-life indicators that were applied to the study patients. In general, the indicators used were well established and of proven validity. Included was one single question that was added intuitively and had not received previous validation: "How long does it take you to recover from a dialysis session?" The responses to this question allow the validation of this simple question as a tool to be used in HD clinical research. Twenty-three patients who were treated by frequent HD (5 to 7 d or nights) and 22 control subjects who were treated by thrice-weekly dialysis were studied during an 18-mo period. The "time to recovery" question was administered along with a battery of renal disease-specific questionnaires and the Generic Medical Outcomes Survey 36 Item-Short Form (SF-36) plus the global Health Utilities Index. Missing data rates, reliability over time, construct validity, and sensitivity to change were assessed from the "time to recovery" responses by standard methods. The question was administered on a total of 314 occasions and answered successfully on 313. The test-retest correlation over 3-mo intervals was highly significant (r = 0.962, P = 0.000; n = 100). Convergent construct validity was established by significant correlations between time to recovery and fatigue (r = 0.38, P = 0.000; n = 313), dialysis stress (r = 0.348, P = 0.000), disease stress (r = 0.374, P = 0.000), SF-36 subscales especially vitality (r = -0.356 P = 0.000), and the Health Utilities Index (r = -0.232, P = 0.000). These scales captured mainly physical or physiologic domains. Divergent construct validity was established by lack of correlations between "time to recovery" and a number of subscales that captured mainly emotional or psychosocial domains, e.g., SF-36 subscale for "role emotional" (r = -0.102, NS) and dialysis stressors such as access problems (r = -0.015, NS) or equipment malfunction (r = 0.032, NS). Test sensitivity was established when the conventionally dialyzed group showed no significant difference in time to recovery between baseline and other time periods, whereas the daily/nocturnal group had a significant reduction between baseline (while on conventional dialysis) and the result at each other time period (minimum P = 0.05). There also was a significant difference between the control and experimental groups over time (ANOVA P = 0.000). The response to the question, "How long does it take you to recover from a dialysis session?" is interpreted easily, is easy to which to respond, shows stability over time by test-retest, shows both convergent and divergent validity, and is sensitive to change. As such, it should be considered as a standard question in HD-related studies in which a health-related quality-of-life outcome is examined.

摘要

患有终末期肾衰竭且接受血液透析(HD)治疗的患者面临着一种压力巨大的慢性疾病,其治疗方案要求苛刻,会影响生活质量。生活质量领域可以通过易于完成、可靠、有效且对变化敏感的评估问卷来衡量。目前人们对提供比传统每周三次更频繁治疗(如每日治疗)的血液透析方案很感兴趣。已有报道称这些方案能改善生活质量。一项已发表的前瞻性队列对照研究(伦敦每日/夜间血液透析研究)纳入了多项应用于研究患者的生活质量指标结果。总体而言,所使用的指标已确立且经过验证有效。其中包括一个直观添加且此前未经验证的单一问题:“你从一次透析治疗中恢复需要多长时间?”对这个问题的回答使得这个简单问题作为一种可用于血液透析临床研究的工具得到了验证。在18个月的期间内,对23名接受频繁血液透析(每周5至7天或夜间)治疗的患者和22名接受每周三次透析治疗的对照受试者进行了研究。“恢复时间”问题与一系列肾脏疾病特异性问卷、通用医疗结果调查简表36项(SF - 36)以及全球健康效用指数一起进行询问。通过标准方法从“恢复时间”的回答中评估缺失数据率、随时间的可靠性、结构效度和对变化的敏感性。该问题总共询问了314次,成功回答了313次。3个月间隔的重测相关性非常显著(r = 0.962,P = 0.000;n = 100)。通过恢复时间与疲劳(r = 0.38,P = 0.000;n = 313)、透析压力(r = 0.348,P = 0.000)、疾病压力(r = 0.374,P = 0.000)、SF - 36子量表尤其是活力(r = -0.356,P = 0.000)以及健康效用指数(r = -0.232,P = 0.000)之间的显著相关性建立了收敛结构效度。这些量表主要涵盖身体或生理领域。通过“恢复时间”与一些主要涵盖情感或心理社会领域的子量表之间缺乏相关性建立了区分结构效度,例如SF - 36“角色情感”子量表(r = -0.102,无显著性差异)以及透析应激源如通路问题(r = -0.015,无显著性差异)或设备故障(r = 0.032,无显著性差异)。当传统透析组在基线和其他时间段之间的恢复时间无显著差异,而每日/夜间透析组在基线(接受传统透析时)和其他每个时间段的结果之间有显著降低(最小P = 0.05)时,建立了测试敏感性。随着时间推移,对照组和实验组之间也存在显著差异(方差分析P = 0.000)。对“你从一次透析治疗中恢复需要多长时间?”这个问题的回答易于理解,易于回答,通过重测显示出随时间的稳定性,显示出收敛效度和区分效度,并且对变化敏感。因此,在研究与健康相关的生活质量结果的血液透析相关研究中,应将其视为一个标准问题。

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