Health-Related Quality of Life in Pacemaker Patients: A Single and Multidimensional Self-Rated Health Comparison Study

Abstract

Since implantation of the first permanent pacemaker in 1958, significant advances have been made in pacemaker technology. To date, however, health-related quality of life (HRQoL) in a large pacemaker population has not been investigated. With dwindling clinical resources, it is important to study HRQoL in a pacemaker population in a reliable and straightforward manner. This study aimed to determine and compare single and multidimensional self-rated health (SRH) in a pacemaker population in terms of sociodemographic characteristics, pacemaker mode and symptoms. The findings showed that irrespective of whether the perspective was single or multidimensional, this Swedish pacemaker population (n=697) with a mean age of 76 years had an acceptable HRQoL. Men, aged 65–84 years, persons who were cohabiting, who had their own dwelling, who had a DDD or who had a pacemaker for ≤3 and 4–7 years experienced better HRQoL. Efforts need to be made for women, single persons, the elderly and retired persons. In conclusion, the SRH of a pacemaker population can be trustworthy established by means of a single-dimensional SRH question.

Keywords

1 Introduction

Pacemaker therapy was introduced in the 1950s with the main objective of improving survival. Today, high-technological developments have produced increasingly advanced pacemaker algorithms to compensate for and in certain cases replace the heart's inability to vary its rate. The subsequent introduction of atrioventricular synchronous pacemakers (DDDC, AAIC) and ventricular rate adaptive pacemakers (VVIR) has resulted in improved haemodynamics and maximal exercise capacity compared to earlier fixed rate pacemakers (VVIC) [1]. Some studies have suggested that patients with DDD pacemakers have a better health-related quality of life (HRQoL) than those with VVI pacemakers [2–5].

HRQoL can be defined using a holistic, dynamic approach, in which continuous changes in people's lives influence their health and well-being [6]. The patient's quality of life (QoL) can be measured objectively, based on the health status, functioning, financial resources and social contacts, by experts like physicians and nurses or subjectively by means of the patient's own self-rated health (SRH), which is based on happiness, life satisfaction and self-esteem. There are several different approaches to investigate how a person assesses his/her SRH [7]. The measurement of SRH comprises two main strategies, the single-question strategy and the multi-question strategy. The single-question strategy is based on three main categories: global non-comparative SRH, global age-comparative SRH and global time-comparative SRH. From a conceptual standpoint, HRQoL is a multi-dimensional concept, and if more information is desired, multi-questions are to be used [7,8].

The effect of the new pacemaker technology and patients’ SRH have been evaluated in a number of studies [9,10]. The results show that pacemaker patients’ SRH improves to a great extent. Some studies suggest that in comparisons between patients with ventricular pacemakers and those with dual-chamber pacemakers, patients with dual-chamber pacemakers experience better HRQoL [10,11]. However, studies of ventricular pacing with a rate adaptive mode show no differences between the two pacing modes (VVI/R and DDD/R) with respect to either SRH or prespecified clinical outcomes in pacemaker patients [12,13]. The validity of the instruments used can be considered satisfactory, as they have been widely used and tested clinically, but there can be problems with reliability when patients are to answer a large number of questions and feel this is too much for them [14]. Pacemaker care requires continuous quality assurance by means of studies based on interviews or questionnaires. The difficulty in motivating patients to answer a large number of questions can be resolved by using a question from a single perspective that can give equivalent information [6,7]. A low drop-out rate is of great importance to the validity of a study, and having the patient answer a smaller number of questions might increase the reliability. To our knowledge no study has been carried out focusing on whether a single perspective is sufficient, in order to measure QoL in pacemaker patients. The aim of the study was, therefore, manifold: to determine QoL in general as well as to specifically compare pacemaker patients’ QoL from a single-dimensional and a multi-dimensional SRH perspective with respect to socio-demographic characteristics, pacemaker mode and symptoms.

1.1 Literature review

1.1.1 Pacemaker patients’ HRQoL in experimental studies

Investigations of different pacemaker treatments and HRQoL over the past 3 years have largely comprised arrhythmia and heart failure studies. In two thirds of the studies, instruments were used to evaluate pacemaker patients’ HRQoL. There were fewer than 80 patients in four fifths of the studies. The most frequently used instruments were the Minnesota Living with Heart Failure (MHF) instrument [15], the 36-item Medical Outcomes Study Short-Form General Health Survey (SF-36) [16], the Karolinska questionnaire (KQ) [11], the Euro-Qol (EQ-5D) [17,18] and the Ferrans and Powers QoL Index, cardiac version III [19]. All the instruments are considered to be reliable and valid.

1.1.2 Quasi-experimental studies

Slightly more than half of these studies used a one-group, pre-post test design. With respect to pacemaker patients’ HRQoL, earlier studies showed that pacemakers with a rate response gave improved HRQoL, particularly all DDD-systems as compared with VVI-systems in sick sinus syndrome (SSS) [2,20]. It was also found that there were difficulties in measuring experienced health and physical capacity. In the majority of these studies, primarily in the treatment of heart failure, a 6-min walk test was carried out in order to objectively measure physical capacity.

Most of these studies were conducted to investigate atrial arrhythmias, particularly atrial fibrillation (AF), and different treatment possibilities such as ablation, atrial-overdrive pacing and dual site atrial pacing [21–23]. These studies showed that ablation was effective and resulted in equivalent or improved HRQoL in intractable paroxysmal AF. Overdrive pacing also produced a slight improvement in HRQoL, while dual site atrial pacing showed no advantages over right atrial pacing, and health was experienced as the same with both the treatments.

The next largest diagnosis group investigated was heart failure, and different treatment possibilities were considered such as multisite pacing, AF and ablation and pacemaker treatment vs. no pacemaker treatment in heart failure [24,25]. The studies showed that multisite pacing resynchronised the electrical activation, and resulted in a lower New York Heart Association Classification (NYHA Class), fewer hospitalisation days, and increased possibilities for physical activity. When ablation was carried out in these patients, there was an improvement in physical HRQoL. Pacemaker treatment for heart failure was very advantageous when compared with no pacemaker treatment.

1.1.3 Experimental studies

In these studies, different treatments for AF were investigated such as VVI vs. VVI/R pacing and ablation in heart failure [26,27]. In some of these studies, the 6-min walk test was used as an objective test for measuring the patient's physical capacity. The results showed that by means of pacing, ablation and medication, the patients obtained improved physical capacity as well as improved HRQoL.

2 Methods

2.1 Design and setting

A cross-sectional survey of a pacemaker patient population was conducted in a healthcare area in Southern Sweden with 310000 inhabitants. The study was approved by the Committee for Ethics in Medical Investigations, Linköping University, Sweden.

2.2 Patients and reasons for dropout

Consecutive pacemaker patients (N=869) were included if they fulfilled the inclusion criteria of being Swedish speaking and >18 years, and following one reminder 832 patients were included. External exclusions due to no response (n=57) and senile patients (n=2) gave a dropout rate of 7%. Another 76 patients dropped out (9%) due to internal exclusions of missing data (n=69) or refusing to answer a question (n=7), resulting in a total of 697 participating patients (Table 1).

Table 1
Baseline characteristics of a pacemaker population (n=697)

Characteristics

Sex

  Male (%) 51

  Mean age (range/S.D.) 74.2 (27–96/10,9)

  Female (%) 49

  Mean age (range/S.D.) 76.9 (18–98/11,1)

Civil status (%)

  Married/Cohabiting 61

  Single person 39

Employment (%)

  Retired 90

  Employed 10

Pacemaker (%)

  AAI/R^∗   1

  VVI/R 86

  DDD/R 13

Characteristics
Sex
Male (%)	51
Mean age (range/S.D.)	74.2	(27–96/10,9)
Female (%)	49
Mean age (range/S.D.)	76.9	(18–98/11,1)

Civil status (%)
Married/Cohabiting	61
Single person	39

Employment (%)
Retired	90
Employed	10

Pacemaker (%)
AAI/R^∗	1
VVI/R	86
DDD/R	13

∗

Patients with atrial inhibited pacemakers (AAI/R) were included in the dual-chamber pacing (DDD/R) group.

2.3 Instrumentation

Socio-demographic data and clinical characteristics obtained from medical records included six areas: sex, age, civil status, occupation, type of dwelling and place of residence (Table 3). Pacemaker mode information, also obtained from medical records, comprised pacing modes, years with a pacemaker and symptoms such as dizziness and syncope at implantation (Table 4). In measuring SRH there were two main strategies, the single-question strategy and the multi-question strategy. A non-comparative single question was used for the single-question (s-SRH) strategy: Compared with my general level of health over the past 12 months, my health today is: better, much the same or worse. For the multi-question (m-SRH) strategy the Euro-QoL (EQ-5D) was used [28], a questionnaire with few questions for an elderly population. The internal consistency of the EQ-5D, assessed by Cronbach's alpha coefficient, was found to be 0.75.

Table 3
Changes in quality of life in a pacemaker population according to characteristics and a single-dimensional self-rated health (s-SRH) question (n=697)

Characteristics n s-SRH P-value

Better (%) Unchanged (%) Worse (%)

Sex NS

  Women 345 22 58 20

  Men 352 20 62 18

Age 0.001

  ≤64 years   94 33 59   8

  65–84 years 478 21 60 19

  ≥85 years 125 13 61 26

Civil status the year of implant <0.04

  Married/Cohabiting 482 21 62 17

  Single person 215 19 57 24

Occupation

Employed: <0.01

  Day of implantation 172 12 73 15

  Today   56 31 62   7

Old age pensioner: NS

  Day of implantation

  Today 469 21 56 23

Place of residence

Urban: NS

  Day of implantation 559 21 60 19

  Rural today   7 14 72 14

Rural: NS

  Day of implantation 102 19 63 18

  Urban today   29 21 52 27

Dwelling <0.001

  Own 620 22 62 16

  Group dwelling   29   5 36 59

  Nursing home   48   9 56 35

Characteristics	n	s-SRH	P-value
Sex		NS
Women	345	22	58	20
Men	352	20	62	18

Age		0.001
≤64 years	94	33	59	8
65–84 years	478	21	60	19
≥85 years	125	13	61	26

Civil status the year of implant		<0.04
Married/Cohabiting	482	21	62	17
Single person	215	19	57	24

Occupation
Employed:		<0.01
Day of implantation	172	12	73	15
Today	56	31	62	7
Old age pensioner:		NS
Day of implantation
Today	469	21	56	23

Place of residence
Urban:		NS
Day of implantation	559	21	60	19
Rural today	7	14	72	14
Rural:		NS
Day of implantation	102	19	63	18
Urban today	29	21	52	27

Dwelling		<0.001
Own	620	22	62	16
Group dwelling	29	5	36	59
Nursing home	48	9	56	35

Table 4

Changes in quality of life in a pacemaker population according to pacemaker mode characteristics and a single dimensional self-rated health (s-SRH) question (n=697)

Pace	n	s-SRH			P-value
		Better (%)	Unchanged (%)	Worse (%)
Pacing mode					<0.001
VVI/R	604	18	62	20
DDD/R	93	40	54	6

Years with					<0.001
pacemaker
≤3 years	240	39	45	16
4–7 years	208	13	68	19
8–14 years	185	11	67	22
≥15 years	64	8	72	20

Symptoms					<0.001
Gone	434	23	64	13
Still partially present	219	18	55	27
Still present	44	11	45	44

The EQ-5D is a multidimensional questionnaire for assessment of health-related quality of life [28]. It is the result of interdisciplinary collaboration among researchers in Europe, the purpose of which was to operationalise the concept of HRQoL in a small number of dimensions in order to construct a self-administered questionnaire with a limited number of items. The EQ-5D consists of a descriptive system of five dimensions: mobility, self-care, usual activities, pain and anxiety/depression. Each dimension was measured on the three levels: ‘no problems’ (1), ‘moderate problems’ (2) and ‘severe problems or complete incapacity’ (3). Hence, the recorded data are ordered categorically, meaning that the categories represent only a rank order and not a numerical value. One order can replace a set of labels: the verbal descriptors are replaced by the numerals 1, 2 and 3. Statistical methods should, therefore, be unaffected by the relabelling of categories, which means that statistical methods designed for metric, quantitative data cannot be used with ordered categorical data. This non-metric property of categorical data means that the sum of scores of multi-item scales has no interpretable meaning and is, therefore, inappropriate as a global score (Table 7) for a multi-item instrument [29]. Therefore, our approach to obtain an overall measure of the pacemaker patients’ HRQoL was to construct a global conditional index (Tables 8 and 9) based on their responses on the five dimensions of the EQ-5D [30–32].

Table 7

Classification of health-related quality of life (HRQoL) based on the Euro-qol (EQ-5D) [17,18] five-dimensional scale in a pacemaker population (n=697)

Dimension	Criteria
Physical
Mobility	1.	I can walk without difficulty.
	2.	I can walk with some difficulty.
	3.	I am bedridden.

Hygiene	1.	I don't need any help with my daily
		hygiene, meals or getting dressed.
	2.	I have some difficulty washing or dressing
		myself.
	3.	I can't wash or dress myself.

Social
Usual activities	1.	I can manage my usual activities (for
		example work, studies, housework, family-
		and leisure activities).
	2.	I have some difficulty managing my usual
		activities.
	3.	I can't manage my usual activities.

Mental
Pain/discomfort	1.	I have no pain or discomfort.
	2.	I have moderate pain or discomfort.
	3.	I have severe pain or discomfort.

Fear/	1.	I am not anxious or depressed.
depression	2.	I am anxious or depressed to some extent.
	3.	I am extremely anxious or depressed.

2.4 Data procedure

2.4.1 Data processing

Five items from the EQ-5D instrument were used (Table 7). In accordance with the EQ-5D, the classification of health status was defined by the following five dimensions: mobility, self-care, usual activity, pain/discomfort and anxiety/depression. Each dimension was rated using a three-point, ordered, categorical scale. The categories were: no problems (1), some problems (2) and extreme problems (3). There were 243 possible combinations of responses for the five items.

2.4.2 Data analysis

Data were described by means of frequency or proportions. Possible relationships between s-SRH and m-SRH as well as the demographic data were analysed by means of the Spearman rank-order correlation coefficient and/or chi-square analysis. In order to obtain an overall significance level of 0.05, adjustments for multiple tests according to Holm were performed [33].

In order to define a global scale of m-SRH, which would be useful in a clinical setting, the dimensions of mobility and self-care were regarded as representing the physical dimension; pain/discomfort and anxiety/depression were regarded as representing the mental dimension, and usual activities representing the social dimension (Table 7). The categories of the physical and mental dimensions were defined by the pairs of responses within each dimension. The physical and mental dimensions were scored 1, 2 and 3 when the pairs of ordered categorical assessments were (11), (22) and (33), respectively. The pairs of response categories for two items within a dimension, (12), (21), (13) and (31), defined a score of 2, and the pairs of responses (2,3), (3,2) and (3,3) resulted in a score of 3 in the physical and mental dimension. The final global conditional index of m-SRH in this study was defined by the joint distribution of the overall categorical levels of the physical, mental and social dimensions according to nine pairs of categorical combinations of the physical and mental dimensions (Table 8).

Table 8
The global assessment of Euro-qol (EQ-5D) [17,18] defined by the joint distribution of the overall categorical levels of the physical, mental and social dimensions

The mental The social The physical dimension

dimension dimension 1 2 3

1 1 High Acceptable Acceptable

2 Acceptable Acceptable Acceptable

3 Acceptable Low Low

2 1 Acceptable Acceptable Low

2 Acceptable Acceptable Low

3 Low Low Low

3 1 Acceptable Low Low

2 Acceptable Low Low

3 Low Low Low

The mental	The social	The physical dimension
1	1	High	Acceptable	Acceptable
	2	Acceptable	Acceptable	Acceptable
	3	Acceptable	Low	Low

2	1	Acceptable	Acceptable	Low
	2	Acceptable	Acceptable	Low
	3	Low	Low	Low

3	1	Acceptable	Low	Low
	2	Acceptable	Low	Low
	3	Low	Low	Low

Table 9

The criteria for high, acceptable and low quality of life for a pacemaker population (n=697) according to the Euro-qol (EQ-5D) [17,18]

Index category	Definition
High QoL	The pacemaker patient has a high QoL when
	his/her QoL is assessed as follows: physical
	health status (1), mental health status
	(1) and social health status (1).

Acceptable QoL	The pacemaker patient has a acceptable QoL
	when his/her QoL is assessed as follows:
	physical health status (1), mental health
	status (1) and social health status (2–3),
	or physical health status (1),
	mental health status (2–3) and social health
	status (1–2), or physical health status (2–3),
	mental health status (1) and social health
	status (1–2), or physical health status (2),
	mental health status (2) and social health
	status (1–2).

Low QoL	The pacemaker patient has a low QoL when
	his/her QoL is assessed as follows: physical
	health status (1), mental health status (2–3)
	and social health status (3), or physical
	health status (2), mental health status (2) and
	social health status (3), or physical health
	status (2), mental health status (3) and social
	health status (1–3), or physical health
	status (3), mental health status (2–3) and
	social health status (1–3).

The criteria for a ‘high’ level of m-SRH was that there were no problems in any of the activities, and hence the levels of the physical, mental and social dimensions were one, i.e. (111). When the social level was rated two or three, i.e. responses (112) or (113), the global index of m-SRH was defined as ‘acceptable’ (Table 8). When the median levels of the physical and mental dimensions were (23), (32) and (33), the m-SRH was classified as ‘low’ irrespective of the response in the social dimension. For the other combinations of the mental and physical median levels, global self-rated health was regarded as acceptable provided that the social level was rated one or two (Tables 8 and 9).

3 Results

3.1 Health-related quality of life in general

Table 2 shows the distribution of patients for the various combinations of physical, mental and social health status defined by the median level within each dimension. According to the global scale, it can be seen that 30% of the patients had a high HRQoL, 58% had an acceptable HRQoL and 12% had a low HRQoL.

Table 2
Valuations in physical, mental and social health status on the Euro-qol (EQ-5D) [17,18], modified version, in a pacemaker population (n=697)

Euro-Qol health n (%)

status (EQ-5D)

High QoL 111 208   30

Accept QoL 112   14   2

121 131   19

122   33   5

131   2   0.3

132   2   0.3

211   22   2

212   15   2

221   68   10

222 115   17

311   1   0.2

Low QoL 113   2   0.3

123   3   0.5

213   9   1

223   32   5

231   1   0.2

232   11   2

233   9   1

313   4   0.5

322   1   0.2

323   10   1

333   4   0.5

697 100.0

	Euro-Qol health	n	(%)
High QoL	111	208	30

Accept QoL	112	14	2
	121	131	19
	122	33	5
	131	2	0.3
	132	2	0.3
	211	22	2
	212	15	2
	221	68	10
	222	115	17
	311	1	0.2

Low QoL	113	2	0.3
	123	3	0.5
	213	9	1
	223	32	5
	231	1	0.2
	232	11	2
	233	9	1
	313	4	0.5
	322	1	0.2
	323	10	1
	333	4	0.5
		697	100.0

3.2 Single dimensional self-rated health

3.2.1 Socio-demographic data and clinical characteristics

Pacemaker patients ≤64 years and 65–84 years reported unchanged to better SRH the past 12 months, while one fourth of those ≥85 years had worse SRH, as did the group that were single persons. One third of the pacemaker patients who were employed on the day of implantation and when they answered the questionnaire reported better SRH than those who were retired. Half of those living in group dwellings or nursing homes reported worse SRH than those who lived on their own (Table 3).

3.2.2 Pacemaker mode and symptoms

Less than 10% of those with DDD/R systems assessed a worse SRH than one fifth of those with VVI/R systems. Two thirds of the patients who had their pacemaker systems ≤3 years had unchanged or better SRH, while nine tenths of those who had their pacemaker systems ≥15 years reported unchanged or worse SRH. One third of the pacemaker patients reported that their symptoms were still present either partially or totally, and SRH was then reported by two thirds of them as worse as compared with the 10% of patients whose symptoms were gone (Table 4).

3.3 Multidimensional self-related health

3.3.1 Socio-demographic data and clinical characteristics

One fourth of the women reported high SRH as compared with two thirds of the men. The majority of pacemaker patients ≤64 years and 65–84 years had acceptable or high SRH, while one fourth of those ≥85 years had low SRH. One third of those who were cohabiting reported high SRH compared with one fifth of those who were single person. Better SRH was reported by two thirds of the pacemaker patients who were employed on the day of implantation and when the questionnaire was answered than those who were old age pensioner. Two thirds of those who lived in group dwellings reported low SRH compared with nine tenths of those in their own homes who reported acceptable or high SRH (Table 5).

Table 5
Changes in quality of life in a pacemaker population according to characteristics and a multi-dimensional self-rated health (m-SRH) instrument (n=697)

Characteristics n m-SRH P-value

High (%) Acceptable (%) Low (%)

Sex <0.001

  Women 345 23 64 13

  Men 352 37 55   8

Age <0.001

  ≤64 years   94 48 48   4

  65–84 years 478 30 63   7

  ≥85 years 125 18 57 25

Civil status the year of implant <0.04

  Married/Cohabiting 482 34 58   8

  Single person 215 19 68 13

Occupation

Employed: <0.001

  Day of implantation 172 32 61   7

  Today   56 61 39   0

Old age pensioner: NS

  Day of implantation

  Today 469 24 62 14

Place of residence

  Urban: NS

  Day of implantation 559 28 60 12

  Rural today   7 57 43   0

Rural: NS

  Day of implantation 102 34 62   4

  Urban today   29 35 55 10

Dwelling <0.001

  Own 620 32 60   8

  Group dwelling   29   0 36 64

  Nursing home   48 13 56 31

Characteristics	n	m-SRH	P-value
Sex	<0.001
Women	345	23	64	13
Men	352	37	55	8

Age	<0.001
≤64 years	94	48	48	4
65–84 years	478	30	63	7
≥85 years	125	18	57	25

Civil status the year of implant	<0.04
Married/Cohabiting	482	34	58	8
Single person	215	19	68	13

Occupation
Employed:	<0.001
Day of implantation	172	32	61	7
Today	56	61	39	0
Old age pensioner:	NS
Day of implantation
Today	469	24	62	14

Place of residence
Urban:					NS
Day of implantation	559	28	60	12
Rural today	7	57	43	0
Rural:	NS
Day of implantation	102	34	62	4
Urban today	29	35	55	10

Dwelling	<0.001
Own	620	32	60	8
Group dwelling	29	0	36	64
Nursing home	48	13	56	31

3.3.2 Pacemaker mode and symptoms

Two percent of the patients with DDD/R systems reported low SRH as compared with 12% of the patients with VVI/R systems, and half of those with DDD/R systems and one third of those with VVI/R systems reported high SRH. For symptoms, high SRH was reported by 40% of the patients whose symptoms were gone compared with 10% of those whose symptoms were still present (Table 6).

Table 6
Changes in quality of life in a pacemaker population according to pacemaker mode characteristics and a multi-dimensional self-rated health (m-SRH) instrument (n=697)

Pace n m-SRH P-value

High (%) Acceptable (%) Low (%)

Pacing mode <0.001

VVI/R 604 27 61 12

DDD/R   93 49 49   2

Years with NS

pacemaker

  ≤3 years 240 29 62   9

  4–7 years 208 30 57 13

  8–14 years 185 30 60 10

  ≥15 years   64 33 58   9

Symptoms <0.001

  Gone 434 42 50   8

  Still partially present 219   9 78 13

  Still present   44 13 66 21

Pace	n	m-SRH	P-value
Pacing mode	<0.001
VVI/R	604	27	61	12
DDD/R	93	49	49	2

Years with	NS
pacemaker
≤3 years	240	29	62	9
4–7 years	208	30	57	13
8–14 years	185	30	60	10
≥15 years	64	33	58	9

Symptoms	<0.001
Gone	434	42	50	8
Still partially present	219	9	78	13
Still present	44	13	66	21

3.4 Comparison between the single and multidimensional self-rated health perspective

3.4.1 Socio-demographic data and clinical characteristics

Overall, small socio-demographic differences in HRQoL were found between single and multidimensional SRH (Tables 3 and 5). With respect to sex and age, better HRQoL was reported in m-SRH (one third of patients) as compared with s-SRH (one fourth of patients). Civil status and occupation had the same distribution but with a shift towards worse HRQoL in s-SRH. For own dwelling and s-SRH there was better HRQoL (one fifth of patients) as compared with m-SRH (one third of patients). For m-SRH, none of the pacemaker patients living in a group dwelling reported better HRQoL as compared with s-SRH (one tenth of patients).

3.4.2 Pacemaker mode and symptoms

With respect to pacing modes (Tables 4 and 6) it was found that two thirds of those with DDD/R pacemakers reported better or high HRQoL both within s- and m-SRH compared with those who had VVI/R pacemakers. For years with pacemaker, there was better or high HRQoL with s-SRH (one fourth of patients) and m-SRH (one third of patients) when the patients had their pacemakers ≤3 and up to 4–7 years. One tenth of those who had their pacemakers 8–14 years and ≥15 years reported low HRQoL with m-SRH compared with one fifth of those in the same age distribution with s-SRH. When symptoms at implantation was compared for s-SRH and m-SRH, acceptable to low m-SRH was found for 40% of the patients and unchanged to worse s-SRH for 40% of the patients.

4 Discussion

4.1 Methodological considerations

The design of any measure of health status must take into account the areas of application for which it is intended, and in this respect shortcomings have been found in many HRQoL studies of pacemaker patients [2]. These shortcomings comprise, for example, small sample sizes, and in the retrospective studies the patients are relatively young and less ill and their pacemakers comprise the latest technology in pacing [2]. In the present study, where the entire pacemaker population in a healthcare area was used, we are of the opinion that a more impartial picture of pacemaker patients’ HRQoL was obtained. In order to assess the pacemaker patients’ HRQoL in the best way, a combination of instruments was used, something which Stofmeel and colleagues also consider necessary in order to obtain correct results [34]. In this study determination of HRQoL was assessed based on the EQ-5D (m-SRH), which is a general HRQoL instrument that is well tested for reliability and validity [35,36]. In order to more specifically study the group of pacemaker patients, certain questions were selected that are associated with their experiences of being pacemaker patients (Tables 3 and 4). To establish whether m-SRH corresponds to and measures what is intended, the content, construct, concurrent and discriminant validity can be checked. In earlier studies the instrument has been shown to have good content and construct validity [17]. When the results were compared in this study, it was found that the concurrent validity between m-SRH and s-SRH was good, but no discriminant validity was performed. Furthermore, Cronbach's alpha was 0.75, which means that the responses can be considered reliable for m-SRH.

4.2 Health-related quality of life

4.2.1 Socio-demographic characteristics

The study showed that the pacemaker population had an acceptable HRQoL, which is also in agreement with the fact that the health of the elderly population in industrialised countries has improved as compared with that of previous generations. Most elderly individuals today have neither handicaps nor physical impairments [37]. However, the results of our study showed that women, as compared to men, assessed their HRQoL as poorer. Furthermore, elderly patients and women, as compared to younger ages and women, also felt their HRQoL was poorer, which has been found in earlier studies [38,39]. Older women's poorer HRQoL can be caused by the fact that they have fewer and fewer possibilities to carry out daily activities, and their dependence on help can be up to six times greater than that of men [37]. According to Liao et al. [40], a decrease in HRQoL occurs when only a few ADL activities can be carried out daily. With increasing age, cognitive function becomes a more important component of health status. The men in the study experienced their HRQoL as unchanged may consequently be explained partly by the fact that even when they were ≥85 years of age they could continue to carry out many of the tasks they had done previously [37,40].

Those who were old age pensioners at the time of implantation and when the questionnaire was answered experienced no change in HRQoL while, irrespective of age, those who were employed at the time of implantation and when the questionnaire was answered experienced better HRQoL than those who had retired. These findings also indicate that, irrespective of age, the benefit of being physically active and having access to a social context results in a sense of well-being and heightened HRQoL. Avlund et al. [39] also reported similar findings as an explanatory factor with respect to the elderly experiencing their HRQoL as good [39]. The relationship between being less physically and socially active and poorer HRQoL can also explain the lower HRQoL for those who were not cohabiting in the present study as compared to those who were.

In earlier studies of patients with cardiovascular diseases, it has been found that social contacts are not dependent on how often they occur, but on the possibility of good contact resulting in an increased sense of security [41,42]. This finding may explain why there was no significant difference in experienced HRQoL in this study between the pacemaker patients who lived in urban areas and those who lived in rural areas, although more of them who lived in urban areas experienced lower HRQoL than those in rural areas.

It has been found in many studies [37,39] that being able to carry out activities is one of the most important factors with respect to experiencing good HRQoL. This is in accord with our findings that those patients with their own dwelling had higher HRQoL than those living in a group dwelling or nursing home. The same distribution was found for civil status as for age regarding HRQoL, which can mean that the pacemaker patients’ ages and whether or not they were cohabiting were of less importance than having their own dwelling and the possibility of being active and having the social contacts they wanted to have [37,39,42]. Welin et al. [43] showed that a life based on one's own prerequisites with the possibility of independent living, as well as experienced good health, resulted in increased well-being and reduced the risk for early death from cardiovascular disease in previously healthy men [43]. This was confirmed in our study, where 96% of the pacemaker population in rural areas lived in a house or flat in contrast to 88% in urban areas, and of these, those with their own dwelling experienced their HRQoL as being from acceptable to high, irrespective of whether they lived in rural or urban areas.

4.2.2 Pacing mode

The study did not demonstrate any differences between HRQoL and number of years since pacemaker implantation, and the majority experienced an acceptable to high HRQoL. Instead, an even distribution was found between high, acceptable and low HRQoL and number of years they had been pacemaker patients. The patients with DDD systems (13%) experienced higher HRQoL than those with VVI systems, which can be due to the fact that most of the younger patients had DDD systems. The younger patients probably experienced the greatest difference [4], as previously they had often developed a sudden slow pulse with dizziness or fainting, but with the DDD system, and sinus rate variability, they had regained the chance for normal physical activity and a return to work. These findings have also been confirmed by Sheldon et al. [44].

It is of great importance that older individuals for whom a DDD system is appropriate have this kind of pacemaker implanted in order to utilise the heart's haemodynamics in the best possible way, and to reduce atrial fibrillation and the risk of blood clots [45]. Assessing HRQoL in the elderly as a group is complex in that there are large variations between being healthy and living an active life and being prevented from doing so by conditions of old age [2]. Taking this into consideration, it was nevertheless found that elderly persons with DDD systems experienced their HRQoL as somewhat better than those with VVI systems.

The fact that those with DDD systems experienced better HRQoL may have been due to having a more physiological pacemaker system that they were some years younger, and had received more in-depth information regarding living with a pacemaker. Malm et al. [38] showed that focused, in-depth information could provide an increased sense of security that in turn influenced experienced HRQoL in both the patient and family [38].

Even when the individual receives help because of the loss of physical capacity, it has nevertheless been found that a life with decreased chances for social contacts reduces the possibility for an active life and can thereby be experienced as resulting in poorer HRQoL [39].

4.2.3 Symptoms

Dizziness in elderly people is a problem that has undergone much investigation [46]. Depending on the definition used and the population studied, it has been found that from one tenth to one third of elderly individuals have problems with dizziness [46]. In our study a total of two thirds of them became symptom-free (no dizziness or fainting) after pacemaker implantation, and these patients reported an acceptable HRQoL. Rose et al. [47] have also demonstrated that when patients who had problems with fainting received pacemakers, they reported improved HRQoL [47]. When the pacemaker patients in our study reported that their symptoms had partially disappeared, they assessed their HRQoL as acceptable. When they still had the same symptoms after pacemaker implantation as they had before, they reported their HRQoL as acceptable to low, and as the symptoms were primarily fainting or severe dizziness, the results of the study were confirmed by a number of other investigations [47,48]. Rose et al. [47] and Tenetti et al. [48] have shown that repeated fainting or dizziness markedly affects the patients’ entire life situation. In those with severe dizziness there is an association with depressive symptoms. Earlier studies have also shown an increased risk for early or sudden death [47]. As the possibility of having an active life is of greatest importance for well being, this can explain why the younger patients benefited the most (high HRQoL) from being symptom-free [37]. Of those who were employed, two thirds experienced high HRQoL if their symptoms were totally gone as compared to one third of those who were retired. However, Tinetti et al. [46] have demonstrated that dizziness can be a complex problem of ageing where a number of causes contribute to the severe dizziness experienced by elderly persons. According to Tenetti et al. [46], dizziness can be seen as an old age syndrome, which attests to the fact that those patients who have not totally recovered believe that the dizziness is a part of ageing [46]. This indicates that right from the year of implantation, pacemaker patients adjust to the possibilities and/or limitations involved in having a pacemaker.

Pacemaker mode (DDD or VVI) and symptoms (Tables 4 and 6) appeared to be associated when the pacemaker patients assessed their HRQoL, which is in accord with other studies showing that patients with DDD systems experience improved HRQoL as compared with those with VVI systems [4,5,11,36]. However, according to Stofmeel et al. [34] there is a lack of well-validated instruments for measuring pacemaker patients’ experienced HRQoL, which is a number of other studies (often small) regarding pacemaker patients’ HRQoL and pacing mode can be called into question [1,34].

4.2.4 Comparison between single- and multidimensional self-rated health

In the comparison (Tables 3–6) between s-SRH and m-SRH, the results were statistically significant for all characteristics with the exception of two (sex and year with pacemaker). This means that s-SRH can also be used when knowledge about patients’ HRQoL is sought for follow-up of quality assurance, and not only as indicators for healthcare utilisation and sick-listing. It is possible that the more negative HRQoL that was found with s-SRH may be due to the fact that it was limited to the last year, while m-SRH referred to how it was experienced today.

5 Conclusions

The study shows that a Swedish pacemaker population (n=697) with a mean age of 76 years had an acceptable HRQoL. Men aged 65–84 years, those cohabiting, and those with their own dwelling, those who with a DDD system, and those who had a pacemaker system from ≤3 to 4–7 years experienced better HRQoL. Rehabilitation and social activities both in groups and at the individual level are needed for women, single persons, the elderly and retired persons who report lower HRQoL. The majority of HRQoL-instruments used earlier were not tested for validity and reliability, which is why they can be questioned. However, the Euro-QoL has been tested for patients with cardiovascular diseases, and after the addition of specific pacemaker questions it was shown to have the possibility of quality assuring the HRQoL of pacemaker patients in a reliable way. In order to measure quality assurance, specific pacemaker questions seem to be needed, regardless of whether the multi-SRH instrument or the single-SRH question is used. It was also found that pacemaker patients’ SRH can be established by means of a single dimensional SRH question as compared with the multidimensional SRH instrument.

5.1 Clinical and research implications

In order for the patient to be treated with a suitable pacemaker system and thereafter feel that his/her social life is the same as before pacemaker implantation, sensitivity on the part of healthcare professionals is of extreme importance. With this approach, the patient and relatives can receive support when they come in contact with healthcare on an acute basis, and also during future elective pacemaker follow-ups. To enable the pacemaker patient to manage his/her life situation, training and continued education for healthcare professionals is required so that information is given to patients based on the perspectives of gender, age, civil status and employment status. The goal is for patients to be able to practice self-care with good HRQoL. The possibility of improving self-care and increasing the chances of good self-care should be promoted through continual follow-up. To firmly establish this quality follow-up in pacemaker care continued research should be carried out in this area. Based on the knowledge obtained concerning gender and age in particular, a randomised intervention programme focusing on the effects of self-care in pacemaker patients should be conducted. The objective of the intervention should be to shed light on whether increased knowledge about the patient's life situation would provide the possibility of increased HRQoL.

Footnotes

Acknowledgements

The authors acknowledge the support from the Department of Medicine, County Hospital Ryhov, Jönköping, Sweden and the School of Health Sciences, Jönköping University, Sweden.

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	Euro-Qol health	n	(%)
	status (EQ-5D)
High QoL	111	208	30

Accept QoL	112	14	2
	121	131	19
	122	33	5
	131	2	0.3
	132	2	0.3
	211	22	2
	212	15	2
	221	68	10
	222	115	17
	311	1	0.2

Low QoL	113	2	0.3
	123	3	0.5
	213	9	1
	223	32	5
	231	1	0.2
	232	11	2
	233	9	1
	313	4	0.5
	322	1	0.2
	323	10	1
	333	4	0.5
		697	100.0