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临床试验/NCT02409251
NCT02409251已完成不适用

Requesting Behaviour of Rheumatologists Regarding Antinuclear Antibodies (ANA) in Patients With Rheumatologic Complaints

Sint Maartenskliniek3 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2012年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
29
试验地点
3
主要终点
Change from baseline (pre-intervention) % of repeated ANA testing at 12 months (post-intervention)

研究概览

简要总结

The aim of this study is to assess the effect of a simple intervention (a combination of education and feedback) on Antinuclear Antibody (ANA) testing.

This aim was chosen because of the known overuse of many laboratory tests, of which ANA testing is one. As overuse of ANA tests can have negative consequences (both for patients and society), the investigators designed an intervention to see how this would influence Antinuclear Antibody testing by rheumatologists.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •rheumatologists:
  • •rheumatologists who are consulting patients at the rheumatology outpatient clinic of a participating centre

排除标准

  • •rheumatologists:
  • •rheumatologists not working the full study period (pre- and post-intervention) at a participating centre
  • •rheumatologists not giving their consent to participate
  • •Inclusion Criteria patients - all patients with an ANA test requested by an included rheumatologist during the study period
  • •Exclusion Criteria patients
  • •patients with an ANA test requested during a clinical admission

研究组 & 干预措施

Education and feedback

Experimental

The intervention consisted of a one-hour, small group educational session. During this session information on rational ANA testing was provided and feedback on current ANA testing was provided to the rheumatologists. A booster session with the same components was held 6 months after the first session.

干预措施: Education and feedback (Behavioral)

结局指标

主要结局

Change from baseline (pre-intervention) % of repeated ANA testing at 12 months (post-intervention)

时间窗: Pre- and post-intervention (both 12 months)

Percentage of patients with ≥1 ANA test in 12 months (pre- or post-intervention period)

Change from baseline (pre-intervention) % of ANA associated diagnoses at 12 months (post-intervention)

时间窗: Pre- and post-intervention (both 12 months)

Percentage of patients, in which an ANA is done during the study period, with final diagnosis of SLE, SSc, PM/DM, MCTD or SS

Change from baseline (pre-intervention) APR variation between rheumatologists at 12 months (post-intervention)

时间窗: Pre- and post-intervention (both 12 months)

Standard deviation around the mean APR, calculated from the APRs of the individual rheumatologists

Change from baseline (pre-intervention) % of positive ANA tests at 12 months (post-intervention)

时间窗: Pre- and post-intervention (both 12 months)

Percentage of ANA tests reported as positive by the local laboratory. ANA tests reported as 'weakly positive' are regarded as negative.

Change from baseline (pre-intervention) ANA/new patient ratio (APR) at 12 months (post-intervention)

时间窗: Pre- and post-intervention (both 12 months)

Number of ANA tests divided by the number of new patients

Change from baseline (pre-intervention) reaching the of target APR at 12 months (post-intervention)

时间窗: Pre- and post-intervention (both 12 months)

Difference (percentage) between the actual APR and the target-APR defined during the intervention

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Nienke Lesuis

MD

Sint Maartenskliniek

研究点 (3)

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