Patient sample characteristics
All interviews were conducted between 3rd October 2014 and 24th November 2014. Thirty-two participants were interviewed (T1DM
n = 16, T2DM
n = 16). One of the interviews was terminated early, as the participant gave limited one-word answers, despite attempts to encourage more explanation behind their responses. Table
2 show a summary of the characteristics of the study population. The sample covers all the main groups of age, gender, HbA1c, age at diagnosis and duration of DM. There was a good spread between T1DM and T2DM. Interviews varied in length from approximately 12 to 64 min, with an average interview length of 32 min. Recruitment continued until data saturation was reached, and the number of interviews conducted exceeded this point. Confidence that data saturation was achieved was high, as all interviews were conducted by one researcher (JC).
Table 2
Characteristics of the study population
| <20 | 20–30 | 31–40 | 41–50 | 51–60 | 61–70 | >70 | | White | Non-white | <20 | 20–40 | >40 | <40 | 40–60 | >60 | <7.5% | 7.5–10% | >10% | <10 | 10–20 | >20 | <5 | 5–15 | >15 |
T1 | 0 | 1 | 1 | 4 | 8 | 0 | 2 | 6 | 16 | 0 | 6 | 6 | 4 | - | - | - | 1 | 12 | 3 | 5 | 2 | 9 | - | - | - |
T2 | 0 | 1 | 0 | 1 | 1 | 4 | 9 | 10 | 12 | 4 | - | - | - | 3 | 11 | 2 | 4 | 11 | 1 | - | - | - | 1 | 9 | 6 |
Potential attributes for the descriptive system
Analysis of the qualitative data identified eight potential attributes to be considered for the descriptive system.
Fear/Anxiety
Participants discussed emotional responses to having DM, and/or self-managing the condition. Fears, worries and anxieties were linked with a number of components of DM and self-management. Some fears were associated with DM treatment, particularly with insulin. These included a fear of needles, and a fear of being on insulin and the implications that this would have on the individual. Participants also discussed fears or worries of not administering insulin correctly. Such anxieties did not seem to be associated with the length of time that the individual had been on a given type of medication. Individuals still felt uncertain they were doing things as they should, and had a persistent low level of worry despite being on the same medication pathway for a prolonged time period. Some participants spoke of a worry of what diabetes and the implications of having diabetes would mean for them in the long-term. This was linked to the level of information (or lack of) on how DM affects the body, and so some individuals appeared to have a low level of understanding, and as such felt anxious that they would experience problems in the future. Other individuals felt that having too much information was not helpful in allaying fears or worries.
Guilt
Feelings of guilt were discussed by some of the participants, particularly in the context of blood sugar levels. Participants noted that when blood sugar level readings were high as a result of their behaviour, they often felt guilt and shame. Some individuals who had T1DM, and were diagnosed a number of years ago spoke of guilt associated with particular foods. This was still experienced despite alternative approaches to diabetes self-management which have since become the norm (e.g., feelings of guilt after eating chocolate. Historically individuals with DM were advised not to eat sweet foods. Recently self-management plans allow for consumption of all food types, providing insulin regimes are considered.
Stigma
Participants noted that there is a stigma associated with DM. One participant related this to when they were displaying symptoms of a hypoglycaemic episode (commonly referred to as a ‘hypo’). However, most of the comments regarding the stigma of diabetes related to diabetes monitoring and treatment. A number of individuals felt that either monitoring blood sugar levels or administering medication in a public place was not appropriate due to the negative connotations associated with needles. Those individuals altered their own behaviour due to how their actions may be perceived, particularly if children were present.
There was also a feeling that diabetes is negatively portrayed by the media, particularly T2DM. Obesity and poor diet and the media’s portrayal of these in association with diabetes were discussed by some participants. Some individuals went further to discuss how weight and weight management issues were raised by clinicians. They felt there was a misconception that individuals with diabetes had a poor diet or were overweight due to poor decision-making.
Control
The term “control” was often used by participants, however it became apparent that the meaning of control was different for different people. Some participants referred to control in the context of controlling their blood sugar levels, or controlling their diabetes and management of it. For example, individuals discussed keeping control of their diabetes in the context of the monitoring of their blood sugar levels. They would routinely monitor their levels, and perhaps keep a written record of what those readings were. In doing so, they experienced feelings of control, irrespective of what the blood sugar level readings were. Conversely, others spoke of control in that they were able to keep their blood sugar level readings within a given range.
Control was also discussed specifically in the context of self-management. Some individuals felt that they were in control of their diabetes as they could control what they chose to eat, how and when to modify daily behaviours, such as what to eat, or when to test blood sugar levels. This could be interpreted that they were more in control of the self-management of their DM, and does not necessarily equate to achieving good control of their blood sugar levels. For some individuals control of behaviours (and possibly blood sugar levels) meant they felt in control of minimising the risk of diabetes-related complications in the future.
Hassle
Some individuals noted that having diabetes was a ‘hassle’. For some this was related to attending appointments with professionals in order to monitor their DM or diabetes-related complications. Issues such as taking time off work, travelling to and from appointments, parking and so on were problematic (to varying degrees). Others noted having to monitor blood sugar levels was a hassle and it was something that had to be fitted in to daily activities/routine. Although it is not a particularly time-consuming task for most, it was “something else” to have to deal with. Participants mentioned that having to carry blood sugar monitoring equipment, and/or food and medication was also a hassle.
Stress
The term “stress” was frequently used by participants, but its meaning varied between participants. Some noted that there was a degree of stress associated with being diagnosed with DM. For some individuals the stress was associated with uncertainty about the future (what the implications of having diabetes would be for them or how diabetes self-management would impact upon their life). Others spoke of stress relating to managing their diabetes, (planning the day ahead, carrying equipment round etc.). Some participants acknowledged that even routine appointments with health care professionals were a stressful experience. They had concerns over whether they were managing their blood sugar levels correctly, achieving stable and consistent blood sugar levels over a period of time, administering medication correctly, whether their diabetes was “stable” and/or whether there had been any implications of having diabetes on areas of their health (such as neuropathy). Individuals noted that there was a degree of stress with the “review appointments”, and spoke of concerns of being “told off”.
Feeling supported
Individuals noted that self-managing DM was positively affected by feeling supported. The type of support received (and wanted) varied from one person to another. To some the support came from friends and family, and manifested itself in a variety of ways. These included having someone to go with them to appointments, helping lifestyle changes and choices (such as diet and exercise), being there to talk/listen, reminded about monitoring blood sugar levels or to take medication. Some individuals discussed about the need for support from professionals. The level and meaning of support did vary between respondents. They included issues such as getting regular feedback on performance, up-to-date information on diabetes management, a point of contact for questions, and maintaining motivation. Some individuals acknowledged that regular interaction with professionals/clinicians was important to avoid becoming blasé over DM self-management. For some participants having the knowledge and understanding of diabetes and how to manage the condition was vital in order for them to firstly accept the diagnosis, and then to comply with good diabetes self-management techniques.
Freedom
Participants noted that having DM meant that there was a lack of freedom in how they chose to live their daily lives. This could be linked to what activities they chose to do on any given day, or what they chose to eat and when they chose to eat it. Either of these components then contributed to individuals having to consider what they may need to take (or have with them) to monitor and manage their blood sugar levels (such as testing kit or insulin). Some participants noted that due to changes in how people are advised to self-manage their diabetes, they have more freedom, particularly with respect to food choices.
Step IV: Selecting attributes and wording of the items for the questionnaire
Attributes reflecting both health related quality of life (HRQoL) and self-management are included in the questionnaire in order to provide a holistic measure. The questionnaire is designed therefore to be used in the economic evaluation of health care interventions for both T1DM and T2DM that reflects both HRQoL and self-management outcomes simultaneously.
Health attributes
To identify health attributes for the questionnaire, earlier psychometric work conducted with the Diabetes Health Profile (DHP-1/DHP-18) [
12,
13] was used as a starting point. The previous psychometric analyses resulted in a health state classification system amenable to valuation to form a diabetes specific preference-based measure, the DHP-5D. It is based on items from the DHP-18 (mood and barriers to activity) and DHP-1 (fear of hypoglycaemic attacks), supplemented by an item from the SF-6D vitality dimension [
12,
13]. The DHP-5D has five dimensions, psychological distress (2 items of mood and social limitations), disinhibited eating, fear of hypoglycaemic attack (four response levels) and vitality (five response levels).
For this study, the content of the DHP-5D was reviewed by the research team against the results of the patient interviews. In order to be able to incorporate more self-management items it was decided to remove the disinhibited eating item. It was felt that this item overlapped with some of the self-management attributes. The wording of the remaining four items was also reviewed and minor revisions were made to the wording of one item to make it compatible with the self-management items.
Self-management attributes
All self-management attributes identified from the patient interviews were considered by the research team for inclusion in the questionnaire to go alongside the health attributes. The general guiding principle was that attributes should focus on how self-management affects the patient rather than any specific process-related issues.
Fear/anxiety were not included as it was felt they were too vague and in the interviews they were not specifically related to self-management. Guilt was not included as it is a driver of self-management rather than a consequence of self-management. Stigma was not included as it was felt not to be about self-management per se. Control was included with the sense that it is about whether you feel in control of your diabetes (rather than whether you are actually in control). Hassle was included as it was clearly identified to be related to self-management. Although the term hassle was used by the interviewees it was noted that this term needed testing with a patient focus group to make sure it is understandable in this population. Stress was included as it was clearly related to self-management. Feeling supported was included but it was noted that there was weaker support for this attribute from the interviews and so this should be tested in a patient focus group as to whether it should be included or not. Freedom was not included as it was felt to be too closely linked to hassle and control. Therefore four attributes were included (control, hassle, stress and support).
The three attributes from the DHP and energy for the attributes designed to capture HRQoL, and the four attributes identified from the patient interviews cover self-management, resulting in the following eight attributes for inclusion in the questionnaire.
Administering the draft questionnaire
The revised questionnaire was piloted online with 15 DM patients. Patients were asked to complete the descriptive system and give general feedback on whether it was clear and understandable. All patients completed all questions. The spread in responses across the levels in the attributes was good. The only amendment to the questionnaire was that it was suggested that the description of
support should be slightly amended to ‘family, friends and health care professionals’. The final questionnaire (Health and Self-Management in Diabetes questionnaire, HASMID version 1) is shown in Table
3. The HASMID
v1 questionnaire consists of 8-items, each with four response options. Response options are scored from 0 to 3, with a higher score indicating little or no impact upon HRQoL. The overall questionnaire is therefore scored from 0 to 24, with a high score indicating good HRQoL, and a low score indicating poor HRQoL.
Table 3
Descriptive system of the HASMIDv1 questionnaire
Mood | You never find yourself losing your temper over small things |
You sometimes find yourself losing your temper over small things |
You usually find yourself losing your temper over small things |
You always find yourself losing your temper over small things |
Hypoglycaemic attacks | You never worry about going hypo |
You sometimes worry about going hypo |
You usually worry about going hypo |
You always worry about going hypo |
Energy | You are never tired |
You are sometimes tired |
You are usually tired |
You are always tired |
Social Limitations | Your days are never tied to mealtimes |
Your days are sometimes tied to meal times |
Your days are usually tied to meal times |
Your days are always tied to meal times |
Control | You feel you have a lot of control of your diabetes |
You feel you have some control of your diabetes |
You feel you have little control of your diabetes |
You feel you have no control of your diabetes |
Hassle | You find your life with diabetes is never a hassle |
You find your life with diabetes is sometimes a hassle |
You find your life with diabetes is often a hassle |
You find your life with diabetes is always a hassle |
Stress | You find your life with diabetes is never stressful |
You find your life with diabetes is sometimes stressful |
You find your life with diabetes is often stressful |
You find your life with diabetes is always stressful |
Support (All support you have; from family, friends and health care professionals) | You feel totally supported with your diabetes |
You feel you have a lot of support with your diabetes |
You feel you have a little support with your diabetes |
You feel you have no support with your diabetes |