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临床试验/NCT01830803
NCT01830803已完成不适用

Reliability of howRU and howRwe Questionnaires

Medical Research Foundation, The Netherlands1 个研究点 分布在 1 个国家目标入组 101 人开始时间: 2013年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
101
试验地点
1
主要终点
Reliability HowRU and HowRwe

研究概览

简要总结

Quality of life and patient satisfaction are two important concepts in health care, especially in chronic diseases. Currently, there are several instruments available to determine this, but many are not easily applicable in daily practice because of their length and the consequential effort they require from both patients and caregivers.

In the UK, Benson et al. recently developed two short generic patient questionnaires on quality of life and patient satisfaction: the howRu and howRwe questionnaires. Both questionnaires contain four items.

The howRU questionnaire has already been validated and seems highly applicable to be used in large patient groups. The howRwe questionnaire has not been validated yet. The reliability of both questionnaires has not been assessed either. The procedure as suggested by Kocks et al. provides us with the opportunity to perform a reliability procedure on patient level.

The purpose of this study is to assess the reliability of the howRU and the howRwe questionnaires on patient level in the Dutch population.

详细描述

Prior to the start of this study, the howRU and howRwe questionnaires have been translated into Dutch by the MAPI-institute.

All possible eligible patients who are visiting the general practice between February 2013 and April 2013 are asked to complete the howRU questionnaire prior to consultation and the howRwe questionnaire directly after consultation. The scores are not shown to the health care provider who will also complete both questionnaires after consultation as he/she thought the patient should have completed the questionnaires.

An investigator will then select patients based on the scores on the howRU and howRwe questionnaires and their diseases. We will aim to include at least 90 patients: a minimum of 30 patients with diabetes, 30 COPD patients and 30 persons without these diseases. For each patient category, a maximum of 15 patients with a maximum score (defined as 10-12) will be included. All other patients need to have lower scores. As this study aims to assess the reliability of the questionnaires, it is not necessary to select the study participants at random.

The selected patients will be asked to participate in our study. Participating patients will be asked to fill in other questionnaires (EQ-5D and Europep) and the investigator will hold semi-structured interviews, preferably on the day of consultation. Patients are asked to comment on each separate concept of the questionnaires. They are asked what thoughts they had during the completion of the individual questions, and are asked to give examples of these.

The participants' opinions about the questionnaires will also be asked. All interviews will be recorded and fully transcribed. All references to scores on individual items of the questionnaire (in number or words) will be covered with black bars to blind these results. These elaboration will be sent to a reviewing panel consisting of 45 clinicians and 45 patients. They will be instructed to complete the howRU and howRwe questionnaires of a patient, the way they thought the patient should have rated the questionnaires based on the interview, gender and age. Each interview has to be reviewed and scored by five separate clinicians and five patients for both howRU and howRwe.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • 18 years of age or older
  • Visiting the general practice in the period of February/March to May 2013

排除标准

  • Illiteracy
  • Insufficient understanding of the Dutch language
  • Mental retardation
  • Visual impairments, such that the questionnaires can not be read

结局指标

主要结局

Reliability HowRU and HowRwe

时间窗: Average 12 weeks

This primary outcome measure concerns the scores on the howRU and howRwe questionnaires as filled out by the patients and the reviewing panel.

次要结局

  • HowRU and HowRwe physician scores(1 day)

研究者

发起方
Medical Research Foundation, The Netherlands
申办方类型
Other
责任方
Principal Investigator
主要研究者

Henk Bilo, MD

MD PhD

Medical Research Foundation, The Netherlands

研究点 (1)

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