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不同研究者对痴呆随机对照试验中生活质量测量的影响。

The impact of different researchers to capture quality of life measures in a dementia randomised controlled trial.

机构信息

NWORTH Clinical Trials Unit, Bangor University, Holyhead Road, Bangor, Gwynedd, LL57 2PZ, UK.

出版信息

Trials. 2023 Jan 17;24(1):33. doi: 10.1186/s13063-022-07064-4.

Abstract

BACKGROUND

Capturing changes in health and wellbeing within randomised controlled trials (RCTs) can be complex. The precision and accuracy of outcome scales to measure change is crucial, and therefore, consideration needs to be given to potential measurement errors when collecting these outcomes. Many RCTs use multiple researchers to collect data, which has the potential to introduce variation in measurements. This study aimed to identify if there was a measurable effect of using different researchers to collect repeated assessments of quality of life (QoL) at different time points.

METHODS

A previously conducted study assessing the impact of reminiscence therapy on participants with dementia and carer (PwD-carer) dyads, 'REMCARE' (Reminiscence groups for people with dementia and their family caregivers), provided the platform for this exploratory secondary analysis. Data was categorised into two broad groups: those where the same researcher attended all assessments and those where different researchers undertook the assessments. ANCOVA (analysis of covariance) models used in the original REMCARE analysis with the addition of the 'researcher-continuity' variable were run on two QoL measures, the QoL-AD (Quality of Life in Alzheimer's Disease) and QCPR (Quality of the Caregiving Relationship).

RESULTS

Three hundred thirty PwD-carer dyads were included in the analysis. For the PwD, a statistically significant effect was found on the researcher continuity variable for the QoL-AD and QCPR outcome measures at follow-up 1 but not at follow-up 2 signifying an impact of researcher attendance at the first follow-up but not follow-up 2. For the carer data, analyses revealed no statistically significant effects at follow-up 1; however, the QoL-AD measure at follow-up 2 was found to be statistically significant.

CONCLUSIONS

These exploratory results indicate the possible impact of researcher continuity on QoL outcomes in dementia studies. Further research is required to explore this further and establish causality. If demonstrated, this would have implications for the planning of future empirical studies in dementia, in order to reduce this potential source of bias.

摘要

背景

在随机对照试验(RCT)中捕捉健康和幸福感的变化可能很复杂。衡量变化的结果量表的精确性和准确性至关重要,因此,在收集这些结果时需要考虑潜在的测量误差。许多 RCT 使用多名研究人员来收集数据,这有可能导致测量结果存在差异。本研究旨在确定在不同时间点使用不同研究人员重复评估生活质量(QoL)时,是否存在可测量的影响。

方法

先前进行的一项评估回忆疗法对痴呆症患者和照顾者(PwD-照顾者)二人组影响的研究“REMCARE”(痴呆症患者及其家庭照顾者的回忆小组)为这项探索性二次分析提供了平台。数据分为两组:一组是所有评估都由同一名研究人员进行,另一组是由不同的研究人员进行评估。对 REMCARE 分析中使用的协方差分析(ANCOVA)模型进行了扩展,加入了“研究人员连续性”变量,对两个 QoL 测量指标,即 QoL-AD(阿尔茨海默病患者的生活质量)和 QCPR(照顾关系质量)进行了分析。

结果

共有 330 对 PwD-照顾者被纳入分析。对于 PwD,在随访 1 时,研究人员连续性变量对 QoL-AD 和 QCPR 结果测量具有统计学意义,但在随访 2 时则不具有统计学意义,这表明研究人员在第一次随访时的参与度有影响,但在第二次随访时则没有影响。对于照顾者的数据,分析结果在随访 1 时没有显示出统计学意义;然而,在随访 2 时,QoL-AD 测量值具有统计学意义。

结论

这些探索性结果表明,研究人员的连续性可能对痴呆症研究中的 QoL 结果产生影响。需要进一步研究以进一步探索并确定因果关系。如果得到证实,这将对未来痴呆症实证研究的规划产生影响,以减少这种潜在的偏倚来源。

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Changes in the quality of life of people with dementia living in care homes.养老院中痴呆患者生活质量的变化。
Alzheimer Dis Assoc Disord. 2009 Jul-Sep;23(3):285-90. doi: 10.1097/WAD.0b013e318194fc1e.

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