跳至主要内容
临床试验/NCT05360199
NCT05360199已完成不适用

Are Postoperative Patient Patient Reported Outcome Measures Influenced by Recall of Preoperative Scores? - a Randomized Controlled Trial

Centro Hospitalar De São João, E.P.E.2 个研究点 分布在 1 个国家目标入组 236 人开始时间: 2021年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
236
试验地点
2
主要终点
Median COMI score results

研究概览

简要总结

To evaluate whether postoperative PROM scores of spine patients are influenced by memory bias

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Participant)

盲法说明

patients are unaware whether they are in the intervention or control group

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All adult patients with valid preoperative PROM scores submitted to spine surgery due to degenerative pathology from January 2019 to April 2020 at our center (spine unit of a neurosurgical department in a Portuguese university hospital) were included in the study and received PROMs questionnaires with a letter of consent.

排除标准

  • Patients without valid preoperative questionnaires were excluded from the study while patients were lost to follow-up if mail questionnaires were not completed two months after PROMs remittance or if they had submitted incomplete or invalid answers.

结局指标

主要结局

Median COMI score results

时间窗: 4 weeks

Core outcome measures index. Scale 0 to 10 where 0 means the best score

次要结局

  • Median ODI score(4 weeks)
  • Median EQ-5D score(4 weeks)
  • Median NDI(4 weeks)

研究者

发起方
Centro Hospitalar De São João, E.P.E.
申办方类型
Other
责任方
Principal Investigator
主要研究者

Pedro Daniel Valente Aguiar

Doctor

Centro Hospitalar De São João, E.P.E.

研究点 (2)

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