7199 Cognitive debriefing of the HBQOL v1

  • Research type

    Research Study

  • Full title

    A cognitive debriefing study with patients with chronic Hepatitis B (CHB) in the UK to explore and document the content validity of the Hepatitis B Quality of Life (HBQOL) questionnaire

  • IRAS ID

    247313

  • Contact name

    Patrick Kennedy

  • Contact email

    p.kennedy@qmul.ac.uk

  • Sponsor organisation

    Janssen Global Services LLC

  • Duration of Study in the UK

    0 years, 11 months, 31 days

  • Research summary

    Research Summary

    The objective of this work is to explore and document the content validity (that is, evidence that the questionnaire measures what it is intended to measure) of the Hepatitis B Quality of Life (HBQOL) questionnaire through a cognitive debriefing study with patients with chronic Hepatitis B (CHB) in the UK. Cognitive debriefing is a 'think aloud' process where patients complete the questionnaire explaining their interpretation/understanding of each question, and speaking out loud any difficulties or confusion.

    Summary of Results

    What we did and why

    • We spoke to 24 people who are living with chronic hepatitis B.
    • When new treatments are developed for hepatitis it is important that they are assessed for how they affect patients’ health-related quality of life (HRQoL) and wellbeing. The best way do to this is to ask patients how they are feeling and how the treatment is affecting them. One way to do this is to ask patients taking a new treatment to fill out a questionnaire about how they are feeling.
    • We wanted to find out if a questionnaire called the Hepatitis B Quality of Life (HBQOL) questionnaire is suitable for this purpose.
    • To make this assessment, we needed to find out from participants what their hepatitis B-related symptoms and problems are, so that we could check they are included in the questionnaire.
    • We also wanted to find out if the questionnaire is written in words that participants could easily understand, and if participants find it easy to choose an answer to the questions.
    • This helped us to decide if the questionnaire works well, or if we needed to make changes to it before it could be used in any future research.

    What we learned about what it’s like to live with hepatitis B

    • Just over half of the people who took part in this study told us that they had not generally experienced any physical symptoms which is unsurprising as hepatitis B is considered to be broadly asymptomatic.
    • For people who did experience symptoms, the most commonly reported symptom was fatigue; people described feeling tired, weak, and lacking energy.
    • The main impact of hepatitis B appeared to be on how people feel emotionally and psychologically. Many people felt shocked and upset at their diagnosis. After diagnosis it was common for people to have strong feelings of worry and anxiety. People worried about transmitting hepatitis B to others and worried about how the disease would progress. People in this study also told us that they felt depressed and that living with hepatitis B impacted their confidence and identity.
    • Before we started this study we reviewed what other researchers have learned in other studies like this in the past. Most of what we found out in our study matched with what other researchers have reported.
    • However, people in this study told us about two impacts that we didn’t know about before. We learned that people with hepatitis B sometimes need to take time off from work and school to attend appointments, which negatively impacts their work and school life. We also learned that people take general health precautions, like eating healthily and staying active, to cope with their hepatitis B and manage the condition.

    What we learned about the HBQOL questionnaire

    • We learned that most of the questions in the HBQOL are relevant, and ask about things that affect people with hepatitis B.
    • We learned that the most important questions on the HBQOL are the ones that ask about whether you are worried about your health getting worse, and the ones that ask about whether you are worried about passing on hepatitis B to somebody else.
    • Based on the feedback from the people who took part in this study, we made some changes to the HBQOL to make it easier to use in the future.
    • Firstly, we learned that we should change the questions to ask you whether you have experienced each symptom, feeling, or problem “in the past four weeks.” This will allow us to make sure that everybody who completes the questionnaire is thinking about the same time period.
    • Secondly, we learned that some of the words in the questionnaire were difficult to understand.
    • For example, we changed ‘Someone influential, like your boss, might find out about your hepatitis B’ to ‘Someone important like your boss, might find out about your hepatitis B’ to improve clarity.
    • We also changed ‘Hepatitis B might affect your life expectancy’ to ‘Hepatitis B might affect how long you will live.’
    • Finally, we found out that some people with hepatitis B feel bad about themselves, or judge themselves for having hepatitis B. This is known as ‘self-stigma.’ However, the HBQOL doesn’t include any questions about that. People told us that this was an important experience of living with hepatitis B, and so we have suggested to the pharmaceutical company that sponsored this research that they find another questionnaire to measure whether these feelings change when people take treatment for their hepatitis B.

    Thank you to our participants

    • By taking part in this study our study participants have helped us to make sure the HBQOL is a good questionnaire to use to assess how new treatments for hepatitis affect patients’ HRQoL and wellbeing.
    • Our participants have also helped us to better understand what it’s like to live with hepatitis B.
    • Participants’ answers to our questions will help pharmaceutical companies to develop new treatments that improve the symptoms and problems that are most important to people with hepatitis B.

  • REC name

    North West - Greater Manchester West Research Ethics Committee

  • REC reference

    18/NW/0649

  • Date of REC Opinion

    30 Oct 2018

  • REC opinion

    Further Information Favourable Opinion