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www.sciencedomain.org

Recovery Expectations and Quality of Life after

Revascularization Treatments

Renata Ferrari

1*

, Giulio Vidotto

2

, Teresa Ferraro

2

, Federico Tosato

3

and Domenico Milite

3

1

Division of Psychology, San Bortolo Hospital, Vicenza, Italy. 2

Department of General Psychology, University of Padua, Italy. 3

Division of Vascular Surgery, San Bortolo Hospital, Vicenza, Italy.

Authors’ contributions

This work was carried out in collaboration between all authors. Author RF designed the study, wrote the protocol, and wrote the first draft of the manuscript. Authors GV and TF managed the literature searches and the statistical analyses. Authors FT and DM contributed to the definition of the study design. All authors read and approved the final manuscript.

Article Information

DOI:10.9734/BJMMR/2015/14264 Editor(s): (1) Vijay K Sharma, Division of Neurology, Yong Loo Lin School of Medicine, National University of Singapore, National University Hospital, Singapore. Reviewers: (1)Anonymous, University of Sulaimani, Iraq. (2)Arijana Lovrencic-Huzjan, University department of neurology, UHC Sisters of mercy, Zagreb, Croatia.

(3)Anonymous, University of Insubria, Varese, Italy. Complete Peer review History:http://www.sciencedomain.org/review-history.php?iid=718&id=12&aid=6958

Received 25th September 2014 Accepted 28th October 2014 Published 15th November 2014

ABSTRACT

Aims: Despite the recognized effectiveness of revascularization treatments in patients with peripheral arterial disease (PAD), a significant number of patients continue to bear a compromised health related quality of life (HRQoL). The aim of this study was to investigate the role of patients’ recovery expectations in perceived health outcomes after lower-extremity revascularization.

Study Design: Single-center prospective observational study, conducted in the Division of Vascular Surgery – S. Bortolo Hospital, Vicenza - between February 2011 and June 2012.

Methodology: 60 consecutive patients, 26 with critical limb ischemia (CLI) and 34 with intermittent claudication (IC), undergoing open surgery (n = 38) or endovascular interventions (n= 22) were enrolled. Measurement of HRQoL (SF-36 and VascuQoL), mood states (HADS), pain (NRS) and functional status (Pain Disability Index, PDI)were administered before treatment (T1) and at 3-month follow-up (T2).

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Results: ANOVA showed a significant improvement (P < .001) from T1 to T2 in almost all the domains of VascuQoL and in ‘Bodily pain’ scale of SF-36. Positive changes in T2 were also identified in 11-point NRS pain intensity (P < .01) but not in mean scores of anxiety and depression.

Recovery disappointment (negative differences between perceived and expected outcomes) in ‘Occupation’ and ‘Recreation’ scales of PDI were correlated (Pearson r coefficient) with lower improvement in HRQoL indices and higher scores of anxiety and depression.

Conclusion: our findings evidence the role of expectations on perceived health outcomes after treatment in patients with PAD and underline the utility to help patients to develop realistic expectations.

Keywords: Peripheral arterial disease; revascularization; quality of life; expectations; mood state.

1. INTRODUCTION

In patients at the end stage of peripheral arterial disease (PAD), with critical limb ischemia (CLI) and intermittent claudication (IC), the effectiveness of some revascularisation treatments - such as bypass surgery and endovascular treatment- in reducing symptoms and cardiovascular risk has been well established [1,2].

Nonetheless, it is increasingly recognized that traditional methods of assessing outcomes and quality of care in patients with PAD do not fully address the broad range of concerns affecting these patients [3,4]. Recent studies have demonstrated that walking capacity, pain relief and wellbeing, are even more important than clinical outcomes in patients’ health perception [4,5].

According to the biopsychosocial model of health [6], the improvement of health related quality of life (HRQoL) indices, such as physical functioning, emotional and mood state, social functioning, role performance and pain, has become an accredited treatment goal in patients with PAD [7,8].

A consistent reduction of HRQoL in patients with PAD, when compared to health control groups, has been reported in several studies [9,10], mainly in health perceptions, physical mobility, energy, social role, and pain domains.

Moreover, several studies investigated patients with CLI and IC with respect to HRQoL improvements after revascularisation. Overall, these studies showed improvements in HRQoL

between three and six months after

revascularization; no relevant differences after open surgery and endovascular approach were found in any study [5,11,12,13].

Some psychological factors, such us depressive symptoms -which are quite common among patients with PAD [14,15]- seem to be associated with increased functional impairment and early functional decline [14,16], low compliance [17], and poor quality of life [18]. Furthermore, higher anxiety scores in patients with PAD were related to an increase in atypical leg symptoms and pain at rest [16].

A psychological process that may potentially influence the subjectively perceived quality of life after revascularization is the patients’ expectation about the treatment outcomes. The few studies on this topic showed a relation between positive expectations and higher improvement of physical functioning and perceived wellbeing [19].

Overall, there is a paucity of studies that analyze the relation between mood state and functional disability while, to our knowledge, there are no studies investigating the relation between pre-treatment expectations and HRQoL after revascularization in patients with PAD.

Therefore, the aim of the present study was: (i) to examine the relationship between clinical parameters and patient-related outcomes, such as HRQoL, mood state, and perceived functional status before (1-3 days) and after treatments (3 months); and (ii) to investigate the role of expectations on the individually perceived improvement of functional status and personal wellbeing after treatment in patients with PAD.

2. MATERIALS AND METHODS

2.1 Subjects

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study. Ten of them failed to complete the whole evaluation procedure, thus 50 patients formed the final group. Patients characteristics’ are summarized in Table 1.

Exclusion criteria included: age >85, illiteracy, neurocognitive deficits, psychiatric illnesses, history of stroke, neurodegenerative diseases and sensory deficit disorders. All patients are Italian mother-tongue speakers.

2.2 Clinical Data

The primary indications for revascularization (open or endovascular) were severe intermittent claudication (category 3 in Rutherford classification) and critical limb ischemia (category 4,5 and 6). The choice of open vs endovascular revascularization was made according to the TASC II indication (1). Both for the aorto-iliac and the femoral-popliteal district, patients with TASC A and B lesions received an endovascular

treatment while patients with TASC C and D lesions received an open surgical treatment.

2.3 Assessment

All patients underwent a battery of tests 1 day before treatment (T1) and 3 months after treatment (T2). The Institutional Ethics Committee approved the study protocol and all patients signed an informed consent form.

2.3.1 Quality of life

2.3.1.1 Medical outcome study short form (SF-36) [20]

It is a validated self-administered health survey instrument consisting of eight domains: physical function(PF), physical role function (PR), bodily pain (BP), general health (GH), vitality (VT), socialfunction (SF), emotional role function (RE), and mental health (MH). A score from zero to 100 iscalculated for each subscale, with higher values representing a better health perception.

Table 1. Patients’ characteristics*

Patients Total N = 50

Mean age in years (±SD) 67.16 (±9.96)

Range 48-85

Gender Male 33 (66%)

Schooling Primary education 29 (58%)

Junior high school 13 (26%) Senior high school 4 (8%) University 4 (8%)

Current Occupation (yes) 13(26%)

Civil status Married 41(82%)

Single 1 (2%) Divorced or widowed 8 (16%) Clinical factors

Ischemic Cardiopaty (yes) 11 (25%)

Hypertension (yes) 38 (84.4%)

Diabetes mellitus (yes) 14 (31,1%)

Hypercholesterolemia (yes) 15 (33.3%)

Renal disease 6 (13.3%)

Pneumophatia 4 (8.9%)

Obesity (yes) 8 (17.8%)

Smoke (yes) 35 (77.8%)

Rutherford Classification category 3 28 (62.2%) category 4 2 (4.4%) category 5 15 (33.3%)

Diagnosis CLI 20 (40%)

IC 30 (60%

Treatments Open surgery 35 (70%)

Endovascular 15 (30%)

Previousrevascolarization (yes) 9 (20%)

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2.3.1.2 Vascular quality of life questionnaire (VascuQoL) [21]

Itis a disease-specific questionnaire for patients with PAD. The questionnaire contains 25 items subdivided into 5 dimensions: pain, symptoms, activities, social being, and emotional well-being. Scores are based on responses from a 7-point scale for each item; patients’ responses were converted to a scale ranging from 1 (worst possible score) to 7 (best possible score).

2.3.1.3 Numerical rating scale (NRS)

It is a self-report measure of pain intensity that is valid and reliable even in elderly patients and consists of an 11-point scale along whichpatients rate their pain intensity from zero, representing “no pain,” to 10, representing “the worstpossible pain.” Patients were asked to evaluate the “present” and the “maximum” pain perceived in the last month.

2.3.1.4 Emotional-affective variables

Hospital Anxiety and Depression Scale (HADS) [22]. It is a 14-item self-report instrument assessing anxiety (seven items) and depression (seven items) in physically ill subjects. Each item is scored from zero to three; accordingly, possible scores ranged from zeroto 21 for each subscale. The recommended cut-off scores are eight (which suggests the presence of ananxious or depressed state) and 11 (which indicates a probable clinically significant disorder) for eachsubscale.

2.3.2 Functional status perception and expectations

2.3.2.1 Pain disability index (PDI)[23]

It is a questionnaire designed to measure the extent to which chronic pain and diseases interfere with a person’s ability to engage in various life activities.

For each of seven categories of life activity (Family/Home Responsibility, Recreation, Social Activity, Occupation, Sexual Behavior, Self Care, and Life Support Activity), patients are asked to rate their level of disability on a graphic rating scale ranging from 0 (no disability) to 10 (total disability). A total disability score is determined by adding the numerical ratings of the seven categories of life activity (range = 0 to 70).

2.3.2.2 Functional outcome expectations (PDI-Exp)

They were evaluated in T1 by asking patients to rate, throughout the Pain Disability Index Scales, the level of functional impairment predicted after the revascularization intervention. For each PDI scale, patients were asked: “How would you expect your level of disability would be in this specific area after treatment/surgery?

3. STATISTICAL METHODS

Continuous variables were summarised by mean, standard deviation or median, as appropriate; categorical variables were described by counts and percentages.

In order to examine the presence of significant interactions between “time” and “treatment”, a two-way repeated-measures ANOVA, with an a priori contrasts analysis, was performed for quality of life (SF-36; VascuQol), mood state (HADS) and functional status (PDI; HAQ) indices, comparing the pre-treatment scores (T1) and three month after surgery results (T2). Bonferroni correction was used in post hoc analysis to control for Type I errors.

Student’s t-test (for paired samples) for two independent samples was used to detect differences for diagnosis and type of treatment, and between perceived disability at 3 months follow up (PDI_T2) and outcome expectation (PDI-Exp) before treatment.

Pearson r correlation coefficient was performed to investigate the relationship between changes in perceived disability (i.e. differences between patients’ recovery expectations and perceived outcomes 3-month after treatment, PDI), mood states (HADS), and QoL(SF-36; VascuQol) scores.

SPSS 17 software was used for all statistical analysis.

4. RESULTS

4.1 Surgical Outcomes

At 3-month follow-up, graft occlusion rate was

4.55% and major wound complications

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secondary patency 100% All patients regained walking function.

4.2 Quality of Life

In T1, HRQoL in the total sample appeared markedly compromised in the following scales of the SF-36: ‘Physical role’ (mean = 20.41; SD = ±30.90), ‘Bodily pain’ (mean = 29.57; SD = ±13.48) and ‘Physical function’ (mean = 41.94; SD = ±18.31) (Table 2).

As for the VascuQol, the mean ‘Overall’ score at baseline was 3.62 (SD = ±18.31) and lower scores were obtained in ‘Activity’ (mean = 2.89; SD = ±0.85) and “Pain” (mean = 3.09; SD = ±1.12) dimensions.

No significant differences (Student’s t-test) based on diagnosis were found in any SF-36 and VascuQol domains.

Despite a general positive trend from baseline to 3-month follow up in almost all the SF-36 scales, ANOVA showed a significant improvement from T1 to T2 only in ‘Bodily pain’ (T1= 29.77±13.55; T2= 69.73±18.60; F= 27.86; P< .001) scale. As regard the VascuQoL, a significant improvement from T1 to T2 was found in ‘Overall score’ (T1= 3.61±0.86; T2= 5.53±0.86; F=26.33; P< .001), as well as in ‘Activity’ (T1= 2.87±0.85; T2= 5.03±0.95; F= 30.30; P< .001), ‘Symptoms’ (T1= 4.10±1.05; T2= 5.81±0.87; F= 22.98; P< .001),‘Pain’ (T1= 3.12±1.11; T2= 5.47±1.26; F= 21.22; P< 0.001), and ‘Emotional’(T1= 4.37 ±1.14 ; T2= 5.88±0.88; F= 11.32 ; P< .01) domains.

No statistically differences (Student’s t-test) were identified with respect to ‘Diagnosis’ and ‘Treatments’.

4.3 Mood State, Pain and Perceived Disability

In the total group, the prevalence of clinically significant anxiety, as measured by HADS, was 18% before treatment and 10% at 3 months follow-up, while relevant depressive symptoms occurred in 14% of patients at T1 and 18% at T2. No significant differences were found in the mean scores of anxiety and depression between the two assessment times.

A statistically significant decrease was noticed in “present” (T1=2.45±2.21; T2= 0.86±1.71; F=5.27; P< .01) and “maximum” (T1=7.67±8.38;

T2=3.11±3.85; F=7.61; P< .001) pain intensity in 11-point NRS scales from T1 and T2.

With respect to the self-perceived disability, as evaluated by the PDI, a significant improvement was found only in ‘Life-support Activities’ scale (T1=1.98±2.72; T2=0.76±1.23; F=8.62; P< .01), although a general tendency of a lower impairment was noticed in all indices.

No differences (Student’s t-test for two independent samples) were found in the mean scores of anxiety, pain intensity, and functional impairment in T1 and T2 between patients grouped in different categories (28 patients in category 3 and 15 in category 5) according with Rutherford classification. A significant difference between the groups was only found in HADS-Depression scale in T1, with a higher mean score for patients in category 3 (category 3=5.07±2.43; category 5=3.07±2.31; t=2.66; P< .01).

4.4 Functional Outcome Expectations

Regarding the comparison between outcome expectations before treatment (PDI-Exp) and the disability perceived at 3-month follow-up (PDI-T2), significant differences (Student’s t test) in the mean scores were found in the following scales: ‘Occupation’ (Exp-T1=1.82±1.70; T2=3.54±2.67; t=-4.87; P< .001), and ‘Recreation’(T1=2.12±1.97; T2=3.46±2.70; t=-3.98; P< .001). As can be seen in Fig. 1, the mean scores of expected disability in these two scales were lower than those detected at the 3-month follow up.

No significant differences were found in functional outcome expectations based on Rutherford classification (category 3 and 5).

In order to identify the consequences of incongruity between perceived and expected outcomes () in ‘Occupation’ and ‘Recreation’ scales of PDI, Pearson r correlations with HRQoL (SF-36 and VascuQol) and mood states (HADS) indices were examined.

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Health’, ‘Mental Health e ‘Vitality’ scales of SF 36, and with higher scores of anxiety and depression (P< .001).

5. DISCUSSION

The aim of this study was to evaluate the role of subjective appraisal and individual characteristics on the perception of health outcomes after revascularization in patients with PAD. outcome has therefore shifted from surgery related events to patient-oriented result

use of instruments to evaluate the

together with more traditional medical

Table 2. Quality of life and NRS pain mean s

SF-36

Physical function Role physical Body pain General health Vitality

Social function Role emotional Mental health

VascuQol

Activity Emotional Pain Social Symptoms Overall

NRS

Maximum pain Present pain

Fig. 1. Pain Disability Index (PDI) scores before treatment (PDI Exp), an

0.00 1.00 2.00 3.00 4.00 5.00 6.00 7.00

Occupation

Health’, ‘Mental Health e ‘Vitality’ scales of SF-36, and with higher scores of anxiety and

The aim of this study was to evaluate the role of subjective appraisal and individual characteristics on the perception of health outcomes after arization in patients with PAD. The outcome has therefore shifted from

surgery-oriented results and the use of instruments to evaluate the HRQoL together with more traditional medical

parameters, has been strongly suggested In the present study, we analyze the influence of pre-treatment outcome expectations

individual perception of HRQoL.

The pre-treatment HRQoL data, measured both by general (SF-36) and disease

(VascuQol) instruments, replicate those previously reported in patients with PAD [8,10]. Domains related to physical component, such as ‘Physical Role’ and ‘Physical Functi

36 and ‘Activity’ in VascuQol, appeared more compromised before treatments.

Quality of life and NRS pain mean scores at baseline and follow

Base line-T1 3 months-T2

41.94 (±18.31) 66.94 (±18.25) 20.41 (±30.90) 56.63 (±35.27)

29.57 (±13.48) 69.94 (±18.46)

59.61 (±18.20) 62.49 (±16.21) 52.14 (±16.27) 54.49 (±16.02) 59.67 (±23.14) 74.86 (±17.13) 65.12 (±39.67) 85.57 (±27.33) 67.51 (±13.33) 69.39 (±14.50)

2.89 (±0.85) 5.02 (±0.94) 4.40 (±1.14) 5.90 (±0.88) 3.09 (±1.12) 5.48 (±1.25)

4.31 (±1.63) 5.76 (±1.23)

4.11 (±1.04) 5.82 (±0.87) 3.62 (±0.85) 5.54 (±0.86)

7.9 (±1.89) 3.28 (±2.64) 2.46 (±2.19) 0.84 (±1.69)

1. Pain Disability Index (PDI) scores before treatment (PDI-T1), outcome expectations (PDI Exp), and at 3-month follow-up (PDI-T2)

Recreation

PDI-baseline T1

PDI-Exp

PDI-T2

suggested [8,11]. In the present study, we analyze the influence of treatment outcome expectations on the

treatment HRQoL data, measured both 36) and disease-specific (VascuQol) instruments, replicate those previously reported in patients with PAD [8,10]. Domains related to physical component, such as ‘Physical Role’ and ‘Physical Functioning’ in SF-36 and ‘Activity’ in VascuQol, appeared more

cores at baseline and follow-up

P

.001

.001 .01 .001

.001 .001

.001 .01

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Table 3. Correlation coefficients (Pearson r) between ‘ Recreation’* and ‘ Occupation’* scales of PDI and indices of HRQoL and mood state

SF-36 Ricreation Occupation

Social function -0.43 (P= .002)

General health -0.46 (P= .001)

Mental health -0.49 (P= .001)

Vitality -0.55 (P= .001)

VascuQoL

Overall -0.44 (P= .001)

Social -0.47 (P= .001)

Emotional -0.46 (P= .001)

HADS

Depression 0.57 (P= .001)

Anxiety 0.51 (P= .001)

* (difference between perceived and expected outcomes)

Even the changes in HRQol detected 3 months after treatment are consistent with previous findings, sustaining the effectiveness of revascularization interventions [8,10,11] with no differences for diagnosis (critical limb ischemia vs. intermittent claudication) and type of treatment (open surgery vs. endovascular interventions). Significant improvements were found in ‘Overall’ score of VascuQoL and in almost all the other domains of the questionnaire (‘Activity’, ‘Symptoms’, ‘Pain’, and ‘Emotional’); on the other hand, only the ‘Bodily pain’ scales of SF-36 reached the statistical significance . As the VascuQol seems to show more sensitivity to identify important modifications in perceived health conditions after treatment, the present results support the utility to use this disease-specific instrument to measure quality of life in patients with PAD, both for clinical and research purposes.

Moreover, considering the severe negative impact on HRQoL and on functional performance of pain [5], the great improvement in the ‘present’ and in the ‘maximum’ pain intensity at 3 months follow-up uphold the positive results reported above.

Regarding psychological distress in our group, the prevalence of depressive symptoms (14% of patients before treatment and 18% three months after treatment ) and anxiety (from 18% to 10% from baseline to follow up) is very low, with no significant differences in the mean scores of anxiety and depression between the assessment times. Even the significant difference in the pre-treatment mean score of depression found between patients assigned to two different categories of Rutherford classification, seems to

have a poor clinical relevance because of the low scores found in this variable in the whole group.

Previous research identified a prevalence of depressive symptoms ranging from 16% to 30% [14,15,16] and of anxiety in around 29% of patients with PAD [16].

The low incidence of clinically significant depression, previously identified as a relevant factor of increased risk of functional decline and poor quality of life [14] did not allow further investigation on the relationship between mood states and perceived outcomes after treatments. Incidentally, it should be noted that patients enrolled in our research are older than those examined in the cited literature, thus the HADS scale might have had low sensitivity in identifying correctly mood states in a geriatric population.

Regarding the self-perceived disability, a significant improvement from baseline to 3-month follow-up was found only in the ‘Life-support Activities’ scale, which refers to basic life supporting behaviours such as eating, sleeping and breathing, but not in more demanding and complex activities such as working, leisure activities or social functions.

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co-morbidities, evaluated a short time after interventions.

In a systematic review of the relation between patients’ recovery expectations and health outcomes, Mondloch and colleagues [19] found evidence for an association between positive expectations and better recovery results. In the present study, overly optimistic expectations in functional performance were related to worse scores in many HRQoL indices and higher scores in anxiety and depression scales.

Even though various theoretical models offer different explanations about the relationship between expectations and satisfaction in the setting of medical care [19], our data support the need for clinicians to evaluate and clarify patients’ expectations during pre-surgical consultation and to help them to develop appropriate expectations of recovery after revascularization.

6. CONCLUSION

Substantial improvement in quality of life and in life-support activities in patients with PAD from their pre-treatment condition was observed until 3 months after revascularization.

In recent decades, there has been growing recognition that patients’ perceptions of their health are as important as clinical data: thus, taking care of patients’ emotional and cognitive state and supporting improvements in their autonomy and independence is recognised as equally important.

To this purpose, patients’ recovery expectations are a potentially important determinant of perceived health state and outcome evaluation after treatment, yet they remain barely unexplored in the field of vascular surgery.

Our findings underscore the importance of

identifying patient-oriented outcome

expectations, as overly optimistic expectations before treatment are associated with lower improvement in quality of life indices and higher psychological distress after medical treatments. This analysis should assist the surgeon to convey more realistic expectations to the patients during the pre-operative consultation, and clinicians to educate and support patients along the whole recovery process.

This study has some limitations. Firstly, our results cannot be generalized since the number of enrolled patients is low and all participants were recruited from only one hospital (single-centre study). Secondly, the assessment time point was limited to 3-month follow up, while it would be interesting to extend the evaluation to at least 1 year. Lastly, functional outcome was assessed only by means of a self-report questionnaire, so we ignore if the improvement perceived by patients is actually connected to changes in daily activities performance.

Further investigations should analyze the influence of expectations over time, their relationship with mood states, and the efficacy of pre-treatment psycho-educational interventions in preventing or diminishing these psychological risk factors of poor outcomes after revascularization.

CONSENT

All authors declare that written informed consent was obtained from all the patients that participated in the present study. The written consents are available for review by the Editorial Board members of this journal.

ETHICAL APPROVAL

All authors hereby declare that the present study has been examined and approved by the appropriate Institutional Ethics Committee for Clinical Trials (study number assigned: 38/11 B) and has therefore been performed in accordance with the ethical standards laid down in the 1964 Declaration of Helsinki.

COMPETING INTERESTS

Authors have declared that no competing interests exist.

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© 2014 Ferrari et al.; This is an Open Access article distributed under the terms of the Creative Commons Attribution License

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Peer-review history:

Figure

Table 3. Correlation coefficients (Pearson r) between ‘∆ Recreation’* and ‘∆ Occupation’*scales of PDI and indices of HRQoL and mood state

References

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