Impact of hypoglycaemia on QoL V1
Research type
Research Study
Full title
Developing a preference-based quality of life (QoL) measure to determine the impact of hypoglycaemia in people with diabetes (PwD)
IRAS ID
274146
Contact name
Jill Carlton
Contact email
Sponsor organisation
Sheffield Teaching Hospitals NHS Foundation Trust
Clinicaltrials.gov Identifier
20302, Sheffield Teaching Hospitals project reference number
Duration of Study in the UK
0 years, 11 months, 28 days
Research summary
Research Summary
What domains of Quality of life (QoL) need to be incorporated into an instrument appropriate for measuring the impact of hypoglycaemia on QoL in people with diabetes?
The estimated worldwide prevalence of diabetes mellitus (DM) was 415 million people in 2015, which is expected to increase to 642 million by 2040 (Ogurtsova et al. 2017). The management of diabetes often involves treatment with insulin or sulphonylureas, which is associated with an increased risk of hypoglycaemia (low blood glucose). Hypoglycaemia can seriously impact the quality of life (QoL) of people with diabetes (PwD). This impact can be assessed using patient-reported outcome measures (PROMs). PROMs attempt to capture the individual’s experiences in a measurable and standardised manner. PROMs can include ‘any report of the status of a patient’s health condition that comes directly from the patient, without interpretation of the patient’s response by a clinician or anyone else’ (US FDA, 2009).
The purpose of this study is to develop a health state descriptive system suitable for measuring the impact of hypoglycaemia on QoL in PwD.
First the project will carry out a review of the existing literature about aspects of QoL affected by Hypoglycaemia in PwD to produce a guide for the interviews.
Next, interviews will take place with a sample of between 30-60 people with diabetes, that vary in age, type of diabetes, treatment type and number of severe hypoglycaemic occurrences. Participants will be identified and recruited via Sheffield Teaching Hospitals NHS trust. Participants will be aged 18+ years with a diagnosis of diabetes and a history of hypoglycaemic event(s). Participants will attend one interview and to review the transcript of their interview.
The data obtained from the interviews will be analysed and used to create a draft descriptive system to be further refined in stage 2 of the project.
Summary of Results
The overall purpose of this international project (called Hypo-RESOLVE) is to reduce the burden and consequences of hypoglycaemia in people living with diabetes. As part of Hypo-RESOLVE we want to understand how hypoglycaemia can affect the day-to-day lives of people living with diabetes. We will be using this information as part of a bigger project to help us develop a questionnaire to measure how hypoglycaemia affects people’s quality of life. The questionnaire will be able to be used in future research studies but also in routine clinical care and the evaluation of treatments, including their cost-benefit.
In Stage 1 we wanted to find out all the ways in which hypoglycaemia (or hypos) can affect people’s lives. We interviewed 32 people who live with either Type 1 or Type 2 diabetes and analysed what they said. Some of the people had experienced hypos for a number of years, others had only experienced a few hypos. We talked to people of different ages, and also different genders too. Some of the people were very aware of when they start to have a hypo – other people were not always aware.
When we looked at the types of things people talked about, we noticed that hypos can affect people in three main categories.
1. Physical functioning
2. Psychological functioning
3. Social functioningWithin each of the categories there were many subthemes. For example, people talked about the impact on work, leisure activities, travel, energy levels and fatigue. We heard about the impact on relationships with friends, family, colleagues, and examples of stigma and discrimination. People also described how hypos made them feel emotionally, such as feeling sad or depressed, anxious, stressed, vulnerable and lonely, and discussed issues such as autonomy and independence. The subthemes are shown in the figure above. We worked together with the Patient Advisory Committee (PAC) comprised of people living with both types of diabetes, to agree a framework that can be used to describe the impact that hypos can have on quality of life.
The framework was informed by what we heard in the interviews, and we used it to help write some draft questions that could be used in a questionnaire to try and measure quality of life in people who experience hypos. We came up with some questions that we tested in Stage 2.
In Stage 2 we interviewed more people who experience hypos. In these interviews we wanted to find out what people thought of the draft questions we had developed in Stage 1. We wanted to find out how relevant the questions were, how easy they were to understand, and whether we had missed out anything important. We also wanted to find out how we should ask the questions. (Sometimes questionnaires are designed to find out ‘how often’ people experience things, other questionnaires are designed to find out ‘how bad’ or ‘how much of a problem’ things are.) We also tested out the recall period (the time we ask people to think about when answering the questionnaire (e.g. ‘in the last week’, ‘in the last month’ etc.). We also wanted to test the instructions on how to complete the questionnaire.
We interviewed 35 people from the UK who experience hypos, and 10 clinicians who help support people who experience hypos. We analysed the results as we went along, which meant that we were able to change some of the draft questions if they were not easy to understand. We used the results of the interviews to decide which questions we should keep to test out further (and which questions we could get rid of). At the end of Stage 2 we had a smaller group of questions that are going to be tested out further to see how they perform in a large online survey (in Stage 3).
In Stage 3 we tested our questions in a large survey. The survey was mainly completed online, with some people completing a paper version as they did not have access to the internet. As well as our draft questions, the survey included questions about the person completing the survey, such as how old they are and what sex they are. There were questions about the person’s experiences of hypos, such as how many they had experienced recently and how aware they are of knowing a hypo is coming. Finally, there were some questions from questionnaires that are often used in research to either measure health or diabetes-related quality of life.
We analysed the results to find out which of our questions worked ‘best’. We used the results with other information, such as how well the questions can be translated into other languages, to help us select which questions should be kept for our new questionnaire. Our final questionnaire contains 14 questions.
REC name
HSC REC A
REC reference
20/NI/0048
Date of REC Opinion
13 Mar 2020
REC opinion
Further Information Favourable Opinion