Reliability of howRU and howRwe Questionnaires

Quality of Life Clinical Trial

Official title:

Reliability of howRU and howRwe Questionnaires

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01830803
• Other study ID #: HowRU/we/1
• Status: Completed
• First received: April 5, 2013
• Last updated: March 20, 2018
• Start date: February 2013
• Est. completion date: May 2014

Study information

• Verified date: March 2018
• Source: Medical Research Foundation, The Netherlands
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Each set of interviews, that will be sent out for review, will contain 10 randomly assigned interviews, including information on the patients' gender and age. The order in which interviews will be in the package will be randomised to prevent fatigue of the reviewers and learning effects in the interviews performed later in sequence. Additionally, all interviews will be sent to a panel of patients. These patients will be selected by an investigator.

For statistical analysis SPSS will be used. The data will be manually entered twice to check for errors. The agreement between patient score, treating physician/nurse practitioner and reviewing panel will be presented in Bland & Altman plots for both the howRU and howRwe questionnaires. To assess normality Q-Q plot will be used.

The concordance between patient scores, treating physician/practice nurse scores, and the mean of the scores of the reviewing clinicians and patients will be studied by Lin's concordance correlation (CCC), an extended intraclass correlation (ICC). Additionally, the scores of the five reviewing clinicians will be compared to the scores of the patient panel, also using the ICC.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 101
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 18 years of age or older

• Visiting the general practice in the period of February/March to May 2013

Exclusion Criteria:

• Illiteracy

• Insufficient understanding of the Dutch language

• Mental retardation

• Visual impairments, such that the questionnaires can not be read

Related Conditions & MeSH terms

• Quality of Life

Locations

Country	Name	City	State
Netherlands	General Practice Blanker en Thiele	Zwolle	Overijssel

Sponsors (1)

Lead Sponsor	Collaborator
Medical Research Foundation, The Netherlands

Country where clinical trial is conducted

Netherlands, 

References & Publications (2)

Benson T, Sizmur S, Whatling J, Arikan S, McDonald D, Ingram D. Evaluation of a new short generic measure of health status: howRu. Inform Prim Care. 2010;18(2):89-101. — View Citation

Kocks JW, Kerstjens HA, Snijders SL, de Vos B, Biermann JJ, van Hengel P, Strijbos JH, Bosveld HE, van der Molen T. Health status in routine clinical practice: validity of the clinical COPD questionnaire at the individual patient level. Health Qual Life Outcomes. 2010 Nov 16;8:135. doi: 10.1186/1477-7525-8-135. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reliability HowRU and HowRwe	This primary outcome measure concerns the scores on the howRU and howRwe questionnaires as filled out by the patients and the reviewing panel.	Average 12 weeks
Secondary	HowRU and HowRwe physician scores	The agreement and concordance between patient scores and treating physician/nurse practioner scores on both the howRU and the howRwe questionnaires.	1 day