Heart failure (HF) is a chronic, symptomatic and progressive disease associated with reduced health-related quality of life (HRQoL) in both patients and their caregivers. This study assessed the HRQoL of HF patients (n=191; mean age 70 [range 21–95] years; New York Heart Association [NYHA] class II–IV) and their caregivers (n=72; mean age 69 [range 43–88] years) in England. Patients had poor HRQoL assessed by the EQ-5D-5L weighted index (mean ± standard deviation [SD] 0.60 ± 0.25 [normal 0.78 ± 0.26 for people aged 65–74 years]). The impact of HF on patients’ HRQoL varied markedly; importantly, the extent of comorbidity most influenced the reduction in patients’ HRQoL, as well as disease-related symptoms. The impact on HRQoL on caregivers of patients with HF was on average limited, with the EQ-5D-5L index for caregivers (0.75 ± 0.18) in-line with the normal values for their age range. However, as with the patients, the impact on HRQoL varied markedly, with some caregivers having a bad caregiving experience as measured by the Carer Experience Scale weighted index. This study provides important information on the impact on HRQoL and burden of HF for patients and their caregivers.
For UK healthcare professionals only
Heart failure (HF) is a chronic condition affecting more than 500,000 individuals in the UK.1 As well as substantial mortality, HF also has a negative impact on health-related quality of life (HRQoL).2 HRQoL is predictive of hospitalisation and mortality in HF,3,4 and improvement of HRQoL is an important component of HF management.5
Informal caregivers are an immense asset to the National Health Service (NHS) in the UK, alleviating the burden on resources and costs.6 However, caring for patients with chronic diseases, such as HF, can have a detrimental impact upon the caregivers themselves, reducing their ability to provide effective care.7
Improving HRQoL of people with chronic conditions and their caregivers is one of the UK government’s key priorities for NHS England, as set out in the NHS Outcomes Framework.8 The identification of factors associated with changes in HRQoL is important to help inform clinical decisions. This study assessed the HRQoL of patients with HF and their caregivers in England using patient- and caregiver-reported measures.
This was a multi-site (seven centres in England), non-interventional, cross-sectional, descriptive study of patients with HF and their primary caregivers (A non-interventional Study meaSuring the Economic burden of heart failure to Society in the United Kingdom via patient and caregiver Surveys; the ASSESS study), conducted from January to May 2015. The study protocol was approved by a National Research Ethics Services Committee (ref 14/SC/1321). Written informed consent was obtained from study participants prior to enrolment.
Patients aged ≥18 years, with chronic HF (New York Heart Association [NYHA] class II–IV) diagnosed at least 12 months before enrolment were included. Patients participating in any clinical trial for HF, or currently treated for an episode of acute decompensated HF were excluded. Patients were invited to nominate a caregiver (informal, non-professional primary caregivers of eligible patients, aged ≥18 years) to participate; this was not mandatory to their own participation. Potential participants were excluded if they were not fluent or literate in English.
Patients completed the EuroQol-five-dimensions, five-level (EQ-5D-5L) questionnaire, a generic instrument comprising of a visual analogue scale (VAS) of self-rated general health, an assessment of five health domains and a weighted index of the five domains;9 and the Kansas City Cardiomyopathy Questionnaire (KCCQ), a HF-specific HRQoL measure that assesses the effect of HF on physical limitations (six items), HF specific symptoms (e.g. swelling, shortness of breath, and fatigue) – assessing frequency (four items), severity (three items) and stability (one item), quality of life (three items), social limitations (four items), and patients’ assessments of their disease knowledge, called self-efficacy (two items).10 Caregivers completed the EQ-5D-5L and the Carer Experience Scale (CES), which measures care-related welfare over six domains and as a weighted index.11,12
This study was not testing any hypothesis; therefore, no formal power calculations were performed. Descriptive statistics were summarised separately for patients and caregivers. Analyses stratified by left ventricular ejection fraction (LVEF) ≤35% or >35% were performed, showing that HRQoL scores were generally similar between LVEF subgroups; however, in view of small numbers in the subgroups and the lack of power to consider differences between them, only aggregated data are presented.
Median regression models were used to explore the determinants of patients’ HRQoL (100*EQ-5D index and KCCQ summary scores), caregivers’ HRQoL (100*EQ-5D index) and caregivers’ burden of care (CES index). The variables explored were medical history including comorbidities and NYHA class, and sociodemographics including income and the index of multiple deprivation (IMD), an official measure of relative deprivation for small areas in England. The IMD ranks the 32,482 small areas in England from most deprived to least deprived, dividing them into deciles.13
Demographics of the patients and caregivers and details of patients’ medical history are shown in table 1. A total of 191 patients and 72 caregivers completed the study. The demographic characteristics of the patients were generally in-line with the 2014/2015 National HF Audit for Britain, although the mean age was slightly younger in this study (70 years vs. 78 years).14 Caregivers were mostly women (82%), mainly the spouse (87%) and of similar age to the patients (mean age 69 years). The majority of both patients and caregivers were retired (75% and 77%, respectively), with an annual income estimate of less than £15,000 (59% and 78%). Overall, 10% of patients and caregivers were living in the most deprived areas as measured by the IMD.
On average, patients reported significant reduction in HRQoL, with a wide range of reported values (table 2). The mean EQ-5D-5L weighted index for its five domains of mobility, usual activities, self-care, pain/discomfort, and anxiety/depression was 0.60 (standard deviation [SD] 0.25; median 0.66; range –0.27 to 1.00; normal mean values are 0.78 [SD 0.26] for people aged 65–74 and 0.73 [SD 0.27] for people aged ≥75 years15) and the mean VAS score for all patients was 63 (SD 20; median 65; range 10–100) (table 2). The most affected domains were mobility and usual activities (figure 1).
The median KCCQ clinical summary score, which assesses patients’ physical limitations and frequency of symptoms, was 57 (best state 100), with a range of 3–100 (table 2). The median overall summary score, derived by summing the clinical summary score and the quality of life and social limitation scores, was 50 with a range of 3–100 (table 2). Patients presented the lowest domain scores, and, thus, a high burden, for physical limitation, symptom stability, quality of life and social limitation, with median scores around 50 (best state 100). Symptom frequency, total symptom score, and symptom burden were slightly higher (60–67), whereas the highest mean score was observed for the self-efficacy domain (79). The ranges for all the domain scores were broad, encompassing the full spectrum of the scoring scale (data not shown).
The CES measures care-related quality of life according to the domains shown in figure 2. Of these individual domains, only 51% of caregivers could do most of the activities, and 15% estimated that they could do few activities outside caring. In addition, 91% received little assistance from organisations and government. The majority of caregivers found caregiving mostly (58%) or sometimes (35%) fulfilling; however, 7% found it rarely fulfilling. Overall, 10% of caregivers reported that they were in control of few aspects of the caring. The mean CES weighted index for all caregivers was 39, with a range of –0.1 to 86 (best possible score 100) (table 2).
The EQ-5D-5L weighted index for all caregivers was 0.75 (SD 0.18, median 0.77; range 0.28–1; best possible score 1; normal value for people aged 65–75 0.78 [SD 0.26]) and the VAS score was 78 (SD 17; median 80; range 35–100; best possible score 100) (table 2). For the five domains of the EQ-5D-5L, the majority of caregivers reported no, or only slight, problems (data not shown).
Predictors of HRQoL
Predictors of HRQoL are shown in table 3. Patients with NYHA class II had better HRQoL (EQ-5D-5L index and KCCQ overall summary score) than patients with NYHA class III or IV. Comorbidity decreased HRQoL; every additional comorbidity greater than one reduced the predicted value of the EQ-5D-5L index by –0.02 and decreased the predicted KCCQ overall summary score by –2.94. The only statistically significant predictor of the caregiver’s EQ-5D-5L index was the patient’s EQ-5D-5L index.
This study has two main findings. First, the extent to which HF impacts upon HRQoL differs markedly among patients; importantly, it is the extent of comorbidity that most influences the reduction in patients’ HRQoL, as well as disease-related symptoms. Second, the impact on HRQoL for caregivers of patients with HF varies enormously, with some caregivers reporting a bad caregiving experience; the caregivers HRQoL is associated with that of the patient.
The mean EQ-5D-5L weighted index was substantially lower than the expected value for people aged 65–74,15 and was comparable with prior reports showing poor HRQoL in HF patients in Scotland3 and Sweden.16 Perhaps unsurprisingly for a condition typified by symptoms of exertional breathlessness and fatigue, the most affected domains of EQ-5D-5L were mobility and usual activities. In addition, in keeping with previous observations,2 our study highlights the considerable burden on patients due to physical limitations and the frequency and severity of HF specific symptoms. Indeed, the severity of HF symptoms (NYHA class), as well as the number of comorbidities, were predictors of the level of HRQoL, as has been reported by other studies.2,17 Moreover, we observed the influence of the patient’s HRQoL on that of the caregiver. Thus, it seems appropriate and logical to suggest that improvements are needed in the management of HF to reduce the symptom burden, with the expectation of improving access to specialist care by multi-disciplinary HF teams, effective treatments, and additional patient education and support to help improve adherence to medication and self-management.18,19
While the average impact on HRQoL is clearly significant, the range of values observed is equally, perhaps even more, informative. The most burdened patients had KCCQ summary scores less than 10/100, indicative of an enormous impact on HRQoL. Further, it was the severity of the reduction in HRQoL in patients that impacted upon HRQoL in caregivers, which may in turn affect the caregivers’ abilities to care.20 This observation is likely to be clinically relevant, and we suggest there may be an association between HRQoL in both patient and caregiver with the risk of unplanned hospitalisation for patients with HF and of contact with healthcare professionals for both patients and caregivers.
The care-related quality of life was particularly poor in some caregivers. Nearly half of the caregivers reported limitations in their ability to carry out activities outside caring, and 91% of caregivers reported receiving little assistance from organisations and government. These results suggest that caregivers may benefit from extra support, especially where the patient has a low HRQoL. Since some people may be reluctant to identify themselves as caregivers, limiting their ability to access support, health and social care professionals can play a role by encouraging caregivers to seek support.21
Our study has the same limitations associated with any observational study in patients with long-term conditions. Patients and caregivers were studied at a specific point in time, and observations are likely to have differed at other times. Only 10% of our cohort lived in the lowest decile of socioeconomic deprivation, while over 40% were distributed over the three least deprived deciles. This is likely to have limited our ability to discern differences in HRQoL by socioeconomic status, which have been reported in patients with HF.2,3 The survey was completed directly by participants without the intervention of an interviewer, and, therefore, the quality of the data relied on the participants understanding the questions and their ability to identify suitable responses. Furthermore, the vast majority were of White British ethnicity, and, therefore, the findings from this study may not be applicable to other UK communities.
In conclusion, this study provides important information on the impact on HRQoL and perceived burden of HF for patients and their family caregivers. Interventions to improve the health and HRQoL of patients with HF and their caregivers are appropriate and should be the focus of multi-disciplinary care in HF.
The authors would like to thank the following study investigators: Dr Cairistine Grahame-Clarke, Dr Simon Williams, Dr Mark Dayer, Professor Theresa McDonagh, and Dr Gershan Davis. Dr Amanda Prowse provided editorial assistance in the preparation of the manuscript. Quintiles, Inc. provided analytical assistance.
Conflict of interest
The study was funded by Novartis Pharmaceuticals Ltd. JC, RH, DK and VG are employees of Novartis Pharmaceuticals Ltd. IS has received honoraria for participation in educational events and advisory boards organised by Novartis. JG’s institution has received support for research from Novartis.
- The impact of symptoms and health-related quality of life (HRQoL) are important aspects in the management of patients with heart failure (HF), a chronic, symptomatic and progressive disease
- In this study, patients with HF had poor HRQoL
- The number of comorbidities and New York Heart Association (NYHA) class were independent predictors of the patient’s HRQoL
- Some caregivers had a poor caring experience
- Interventions to improve the health and HRQoL of patients with HF and their caregivers are required.
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