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提高荷兰医疗保健监管判断的可靠性和有效性的实验研究:一项随机对照试验及前后案例研究。

Experimental studies to improve the reliability and validity of regulatory judgments on health care in the Netherlands: a randomized controlled trial and before and after case study.

作者信息

Tuijn Saskia M, van den Bergh Huub, Robben Paul, Janssens Frans

机构信息

O&I, IGZ, Utrecht, The Netherlands.

出版信息

J Eval Clin Pract. 2014 Aug;20(4):352-61. doi: 10.1111/jep.12136. Epub 2014 May 12.

Abstract

RATIONALE, AIMS AND OBJECTIVES: We examined the effect of two interventions on both the reliability and validity of regulatory judgments: adjusting the regulatory instrument and attending a consensus meeting.

METHOD

We adjusted the regulatory instrument. With a randomized controlled trial (RCT) we examined the effect of the adjustments we made to the instrument. In the consensus meeting inspectors discussed cases and had to reach consensus about the order of the cases. We used a before and after case study to assess the effect of the consensus meeting. We compared the judgments assigned in the RCT with the unadjusted instrument with the judgments assigned with the unadjusted instrument after the consensus meeting. Moreover we explored the effect of increasing the number of inspectors per regulatory visit based on the estimates of the two interventions.

RESULTS

The consensus meeting improved the agreement between inspectors; the variance between inspectors was smallest (0.03) and the reliability coefficient was highest (0.59). Validity is assessed by examining the relation between the assigned judgments and the corporate standard and expressed by a correlation coefficient. This coefficient was highest after the consensus meeting (0.48). Adjustment of the instrument did not increase reliability and validity coefficients.

CONCLUSIONS

Participating in a consensus meeting improved reliability and validity. Increasing the number of inspectors resulted in both higher reliability and validity values. Organizing consensus meetings and increasing the number of inspectors per regulatory visit seem to be valuable interventions for improving regulatory judgments.

摘要

原理、目的和目标:我们研究了两种干预措施对监管判断的可靠性和有效性的影响:调整监管工具和参加共识会议。

方法

我们调整了监管工具。通过随机对照试验(RCT),我们研究了对该工具所做调整的效果。在共识会议中,检查员讨论案例,并必须就案例的顺序达成共识。我们采用前后案例研究来评估共识会议的效果。我们将RCT中使用未调整工具时给出的判断与共识会议后使用未调整工具时给出的判断进行比较。此外,我们根据这两种干预措施的评估结果,探讨了每次监管检查增加检查员人数的效果。

结果

共识会议提高了检查员之间的一致性;检查员之间的方差最小(0.03),可靠性系数最高(0.59)。有效性通过检查所给出的判断与公司标准之间的关系来评估,并用相关系数表示。该系数在共识会议后最高(0.48)。调整工具并没有提高可靠性和有效性系数。

结论

参加共识会议提高了可靠性和有效性。增加检查员人数导致可靠性和有效性值都更高。组织共识会议和每次监管检查增加检查员人数似乎都是改善监管判断的有价值的干预措施。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9088/4282468/679071191e7f/jep0020-0352-f1.jpg

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