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Purpose:  Summarize and appraise an article for bias and validity in a collaborative environment.

Instructions: Carefully read, summarize, and appraise the assigned article.  The discussion board for this week should cover the following concepts in order to have a complete draft by the end of the week. As you provide input to your peers, be sure to state a rationale for your claims. 

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1. Identify and discuss the broader importance of the topic of the study as it applies to patients and organizations.

2. Discuss the nursing implications of the findings of the research.  Consider the following questions:

o Were the results statistically significant, if reported?   

o What is the clinical significance of the findings? 

o What are the risks vs. benefits to practice of the findings?  

o Are the findings feasible to implement?

124 | wileyonlinelibrary.com/journal/ajr Aust. J. Rural Health. 2020;28:124–131.© 2020 National Rural Health Alliance Ltd.

Received: 18 December 2018 | Revised: 16 April 2019 | Accepted: 30 September 2019 DOI: 10.1111/ajr.12587

S P E C I A L I S S U E A R T I C L E

Nurse-led psychological intervention reduces anxiety symptoms and improves quality of life following percutaneous coronary intervention for stable coronary artery disease

Zongxia Chang RN1 | Ai-qing Guo RN1 | Ai-xia Zhou RN1 | Tong-Wen Sun PhD2 | Long-le Ma MD2 | Fergus W. Gardiner PhD3,4 | Le-xin Wang PhD1,5

1Department of Cardiology and Nursing, Liaocheng People’s Hospital, Liaocheng City, China 2Henan Key Laboratory of Critical Care Medicine, Department of General ICU, The First Affiliated Hospital of Zhengzhou University, Zhengzhou, China 3The Royal Flying Doctor Service, Canberra, ACT, Australia 4The Australian National University, Canberra, ACT, Australia 5School of Biomedical Sciences, Charles Sturt University, Wagga Wagga, NSW, Australia

Correspondence Professor Le-xin Wang, Department of Cardiology, Liaocheng People’s Hospital, Liaocheng City, Shandong 252000, China. Email: [email protected]

Abstract Objective: To study the effect of nurse-led counselling on the anxiety symptoms and the quality of life following percutaneous coronary intervention for stable coronary artery disease. Design: Randomised control trial. Setting: Rural and remote China. Participants: Rural and remote patients were consecutively recruited from a medical centre located in China between January and December 2014. Interventions: The control group received standard pre-procedure information from a ward nurse on the processes of the hospitalisation and percutaneous coronary intervention, and post-procedural care. The intervention group received a structured 30-minute coun- selling session the day before and 24 hours after the percutaneous coronary intervention, by nurse consultants with qualifications in psychological therapies and counselling. The health outcomes were assessed by a SF-12 scale and the Seattle Angina Questionnaire at 6 and 12 months after percutaneous coronary intervention. The anxiety and depression symptoms were evaluated by a Zung anxiety and depression questionnaire. Main outcome measures: Cardiac outcomes, quality of life and mental health status. Results: Eighty patients were randomly divided into control (n = 40) and interven- tion groups (n  =  40). There was a significant increase in the scores of the three domains of Seattle Angina Questionnaire 12 months after percutaneous coronary in- tervention in the intervention group (P < .01). The mental health and physical health scores also increased (P < .01). In the control group, the mean scores of Zung self- rating anxiety scale 12 months following percutaneous coronary intervention were higher than the baseline scores, and higher than in the intervention group (P < .01). Conclusions: Counselling by a clinician qualified in psychological therapies and counselling significantly reduces anxiety symptoms and improves quality of life.

K E Y W O R D S

cardiovascular medicine, education and remote practice, international health, mental health, nurse practitionershttps://orcid.org/0000-0001-7592-832Xmailto:https://orcid.org/0000-0002-9760-7436mailto:[email protected]

| 125CHANG et Al. 1 | I N T R O D U C T I O N Cardiovascular disease is a leading cause of morbidity and mortality around the globe, responsible for one-third of the deaths worldwide.1,2 In the past three decades, there have been tremendous advances in the management of coronary artery disease and percutaneous coronary intervention (PCI). This has led to a significant improvement in cardiac out- comes in patients suffering from acute coronary syndrome or myocardial infarction.3

However, the impact of PCI on health-related quality of life (QoL), specifically mental health status, is not well un- derstood.4,5 While some studies show improvement in the QoL shortly after PCI, others indicate that the short-term improvement in QoL is not sustainable beyond 1  year.4,5 The factors determining the post-PCI QoL are yet to be de- termined. However, age, lifestyle measures, such as smok- ing and diet, as well as post-procedural self-care are thought to influence a patient’s QoL following successful PCI.6,7 Patients’ mental health status is associated with the outcomes of cardiovascular disease, with depression or anxiety at the time of PCI being related to a higher rate of post-procedural mortality than patients without mental illnesses.8 However, it is unclear whether anxiety or depression has any significant influence on QoL following PCI.

There is limited literature on the effectiveness of pre- and post-procedural counselling on the anxiety symptoms and the QoL following PCI, even though studies have identified that anxiety management is justified before and following PCI.9 While there has been extensive research on the benefits of cardiac rehabilitation following surgery,10 which often have poor rural and remote patient participation, there is a scarcity of quick and effective pre-procedural psychological inter- ventions aimed at a temporary rural and remote population. However, a recent study appears to confirm the belief that a psychological intervention program improves patient mental health following PCI.11 The researchers found that compared to the control group, patients in the intervention group had significantly better mental health, coupled with improved cop- ing styles and reduced levels of cortisol. This study included a single metropolitan based population, with regular access to other interventions. As such, its generalisability is limited, with other studies required to confirm the benefits of a psy- chological intervention on patients who received a PCI.11

The main objectives of this study are to determine the ef- fect of nurse-led counselling on the anxiety symptoms and the QoL following PCI for stable coronary artery disease; and to determine whether there was a general improvement in the cardiac outcomes, QoL and mental health status in rural and remote patients who have received PCI for stable coronary artery disease. Furthermore, the determining factors for post- PCI QoL were also analysed in order to improve the care and outcomes of these patients.

2 | M E T H O D 2.1 | Recruitment of participants Patients were consecutively recruited from a single medical centre (Figure 1) located in rural and remote China between January and December 2014 (12 months). Those selected for inclusion included those aged 18  years or older who were scheduled for elective PCI for stable coronary artery disease. Coronary artery disease was defined as a stenosis of more than 70% in at least one major coronary artery with clini- cal or laboratory evidence of myocardial ischaemia (eg, ST segment depression on ECG during angina or stress testing). Exclusion criteria included the following: (a) unable to give a written informed consent; (b) unable to participate in regular follow-ups at our hospital clinics; (c) a history of psychologi- cal disorders or mental health illnesses; and (d) a history of other chronic illnesses or heart failure (left ventricular ejec- tion fraction <45%).

Participants’ age, sex, level of education, monthly in- comes, general medical history, and current medications were recorded at baseline. The participants were ran- domised by an administration staff member into control and intervention group by a computer-generated randomisation program. Participants were randomised so that there were no statistically significant differences in age, sex, baseline clinical data and coronary disease status between the two

What is already known on this subject: • Percutaneous coronary intervention is associated

with an increased risk of post-procedural anxiety and depression. However, it is unclear whether a nurse-led psychological intervention reduces anx- iety and depression and improves quality of life after percutaneous coronary intervention.

What this study adds: • A nurse-led psychological intervention before and

immediately after percutaneous coronary inter- vention was associated with a significant reduc- tion in anxiety and depression symptoms, and improved quality of life 12 months after percuta- neous coronary intervention.

• Nurse-led psychological intervention and educa- tion should be an integrated part of the care for rural and remote patients undergoing percutane- ous coronary intervention for coronary artery disease, who do not have access to traditional re- habilitation services.

126 | CHANG et Al. groups. The clinical staff were blinded to the patient ran- domisation process.

2.2 | Method of evaluation Three evaluation instruments were administered, at base- line, 6 and 12 months after PCI, by the nursing investigators (Chang ZC, Guo AQ and Zhou AX). Data were collected via face-to-face interviews when patients attended our outpa- tient clinics. Information about their tobacco use, physical activity, diet, mental health status, chest pain and compli- ance to medications was recorded. QoL was assessed with a short form (SF)-12 survey form. The SF-12 survey has 12 items that cover questions on physical functioning, physical health-related role limitations, pain, general health percep- tions, energy levels, emotional problems and general men- tal health. The answers to the questions on the SF-12 are calculated to generate a mental health score and physical

health score. Higher scores indicate less physical or mental disability.12,13

The Seattle Angina Questionnaire (SAQ) was used to as- sess disease-specific health status.14 The SAQ has 19 items that measure coronary artery disease-related health status, with scores ranging from 0 to 100 for each of the five do- mains, covering frequency of angina, restrictions to physical activity, satisfactory to treatment, stability of angina chest pain and QoL. In each domain, a higher score indicates bet- ter health status, with fewer symptoms and better survival.14 Angina frequency scale was defined as no angina (score, 100), monthly angina (score, 70-90), weekly angina (score, 40-60) or daily angina (score, <40). To reduce the workload of the investigators of this study, only frequency of angina, restrictions to physical activity and QoL scores were col- lected and analysed.

To evaluate the impact of generalised anxiety symp- toms, a Zung self-rating depression and anxiety scale was administered at baseline, 6 and 12  months after PCI. The

F I G U R E 1 Study flowchart

| 127CHANG et Al. Zung self-rating depression and anxiety scales were 20-item, self-administered questionnaires for the assessment of depres- sion and anxiety symptoms. They were reliable and validated instrument among Chinese populations.15,16 The 20 items on each scale give a total score from 20 to 80. A higher score denotes more depression or anxiety symptoms. A depression score of 50-59, 60-69 and 70-80 indicates mild, moderate and severe depression, respectively.15,16 An anxiety score of 45-59 and 60-80 denotes moderate to severe anxiety.15,16

2.3 | Psychological intervention The control and intervention groups both received standard pre-PCI care and general counselling about the procedure to be undertaken. The general counselling was conducted by the ward nurse on duty over a brief visit and consisted of com- municating the hospitalisation process and the procedure to be undertaken (ie PCI), and post-procedural care. No indi- vidualised psychological intervention was provided prior to PCI in the control group.

In addition to this standard counselling, the interven- tion group also received a structured 30-minute counselling session the day before and 24 hours after the PCI, by nurse consultants with qualifications of psychological therapies and counselling. The psychological interventions were comprised of individualised cognitive behavioural thera- pies and teaching of relaxation techniques. These measures included identifying the causes of anxiety, challenging and changing unhelpful thoughts or attitudes that may trigger or aggravate anxiety, and the development of personal coping strategies for anxiety prevention and treatment. The nurse consultants also used this time to answer any of the patients procedural and post-PCI concerns or questions. The post- PCI counselling focused on improving the patients’ com- fort level and confidence in participating in post-PCI care recommendations.

2.4 | Data analysis To detect a 10-point difference in the physical or mental health scores on the SF-12 scale, and in the three domains of the SAQ, a minimum of 34 patients were required for this study, to achieve a significance of 0.05 with a power of 80%. QoL measures were analysed by an analysis of variance (ANOVA) at 6 and 12  months following PCI. Categorical data were analysed using a chi-square test. Multivariate logistic regression analysis was conducted to ascertain factors (age, sex, smoking, hypertension, hy- perlipidaemia, diabetes and SAS scores) against the QoL scores. Statistical significance was determined at a P level of <.05.

2.5 | Ethics approval The study protocols received approval from our institutional review board: Human Ethics Committee, Liaocheng People’s Hospital (approval number 201338). Written consent was obtained from all participating patients. This study complied with the CONSORT guidelines, however, was not required to be a registered trail, reflective of local customs in China.

3 | R E S U LT S 3.1 | Patient population There were 20 females and 60 males with a mean age of 59.7 ± 8.7 years (range, 42-79 years; Table 1). Twenty-one (26.25%) patients had primary school education or less, with 34 (42.5%) having a high school education, with the remain- ing 25 (31.25%) having a tertiary education.

The majority of patients had a single or double coronary artery disease, with 11.2% having simultaneous involvement of the three main coronary arteries (Table 1). The left anterior descending coronary artery was involved in more than 83% of the patients (Table 1). None of the patients had a known history of mental health illness, such as depression or anxi- ety, nor were they on any antidepressants. However, six pa- tients (7.5%) had a Zung self-rating depression score of 59 and above at baseline (Table 2), suggesting moderate to severe depression. Five patients (6.3%) had a Zung self-rating anxi- ety score of 45 and above, indicating the presence of anxiety.

3.2 | Cardiac outcomes of PCI Percutaneous coronary intervention was successful in all pa- tients. The number of coronary stents received by each patient ranged from one to six (median = 2). Thirty-six patients (45%) received bare-metal stents, and 44 (55%) had drug-eluting stents. Antiplatelet therapy with clopidogrel and aspirin was adminis- tered to all patients following PCI. There was no statistically significant difference in patients who received bare-metal or drug- eluting stents between the study and control groups (P > .05).

Patients were followed up at our outpatient clinics monthly for 12 months after the procedures. None of the patient expe- rienced myocardial infarction, heart failure, stroke or cardiac arrest. Three (3.8%) patients were admitted to hospital for non-cardiac reasons.

3.3 | Quality of life measures As shown in Table 2, there was a significant increase in the three domains of SAQ, angina frequency, physical limitations

128 | CHANG et Al.

and QoL, 12 months after PCI in the study and control groups (P < .01, Table 2). The physical limitations and QoL scores in the intervention group were higher than in the control group (P < .05, Table 2). Twelve months following PCI, only two (2.5%) patients experienced occasional angina chest pain and repeat coronary angiogram did not reveal any stenotic lesions in the coronary arteries.

The mental health scores and physical health scores on the SF-12 scale were also increased 12  months after the PCI (P < .01, Table 2). The increase in the interven- tion group was higher than in the control group (P < .01, Table 2).

3.4 | Depression and anxiety symptoms following PCI

There was no statistically significant difference in the Zung self-rating depression scores before and after PCI in the inter- vention group or control group (P > .05, Table 2).

The mean scores of Zung self-rating anxiety scales in the control group were higher than in the intervention group following PCI (P  <  .01, Table 2). In the control group, the number of patients with anxiety symptoms and the mean anx- iety rating scores following PCI were higher than the baseline values (P < .05, Table 2).

3.5 | Factors for post-PCI quality of life Logistic regression analysis was performed to assess the fac- tors influencing post-PCI QoL measures, that is QoL scores in the SAQ, the mental health scores and physical health scores in the SF-12 survey. Age, sex, education levels, monthly incomes, co-morbidities, number of coronary lesions, types of coronary stents and post-PCI depression scores were not correlated to the measures for QoL. In the control group, an inverse correlation between Zung anxiety scores and the three QoL measures was identified (r = .822, .781 and .594, respectively, P < .01) following PCI.

Logistic regression analysis was performed to assess the factors influencing post-PCI Zung anxiety scores. Baseline Zung anxiety scores and lower monthly incomes were found to be correlated to the post-PCI Zung anxiety scores (r = .609 and .513, respectively, P < .01).

4 | D I S C U S S I O N This study indicated that PCI or coronary stenting is as- sociated with a significant improvement in QoL at 6 and 12 months in both the control (40.7 vs 63.7) and interven- tion (40.1 vs 83.6) groups, with a significant reduction in the monthly angina frequency in both groups following the procedure (control = 12.5% vs 2.5%; intervention = 22.5% vs 2.5%). In the control group, there was a significant in- crease in the Zung self-rating depression scores (45.7 vs 47.0) and an increase in the number of patients who ex- perienced generalised anxiety symptoms within the first 12 months of PCI (36.0 vs 47.1), whereas the intervention group significantly decreased their Zung self-rating de- pression scores (44.1 vs 24.5) and reduced their general- ised anxiety symptoms within the first 12  months of PCI (38.6 vs 18.9). Furthermore, anxiety symptoms prior to PCI and lower monthly incomes appeared to increase the risk of post-PCI anxiety.

T A B L E 1 Baseline data of the patients

Indices Study (n = 40) Control (n = 40)

Age (y) 59.7 ± 8.7 59.0 ± 7.7

Male/Female 30/10 30/10

Level of education (%)

Primary school or less 10 (25) 11 (27.5)

High school 18 (45.0) 16 (40.0)

Tertiary 12 (30.0) 13 (32.5)

Monthly incomes ($USD; %)

<150 10 (25.0) 12 (30.0)

150-299 16 (40.0) 15 (37.5.0)

>300 14 (35.0) 13 (32.5)

Clinical (%)

Smoking 5 (12.5) 4 (10.0)

Diabetes 13 (32.5) 11 (27.5)

Hypertension 35 (87.5) 34 (85.0)

Hyperlipidaemia 31 (77.5) 28 (70.0)

COPD 7 (17.5) 4 (10.0)

Prior MI or percutaneous coronary intervention

1 (2.5) 2 (5.0)

History of CHF 2 (5.0) 1 (2.6)

Previous stroke 1 (2.6) 0

Peripheral vascular disease

4 (10.0) 3 (4.5)

Angiographic (%)

Single vessel disease (LAD or RCA or left main)

20 (50) 21 (52.5)

Double vessel disease (LAD and RCA, or left main plus LAD or RCA)

15 (37.5) 12 (30.0)

Triple vessel disease (LAD, RCA and left main)

5 (12.5) 7 (17.5)

Abbreviations: COPD, chronic obstructive lung disease; LAD, left descending coronary artery; NS, no statistical significance; RCA, right coronary artery.

| 129CHANG et Al.

Percutaneous coronary intervention has become a nor- mal therapy for patients with acute coronary syndrome. It is also used to provide relief of angina in patients with stable coronary disease.17 PCI and optimised medical ther- apy have been found to reduce the frequency of angina and improve self-assessed health status.17 In line with previous studies, we found that PCI in patients with stable coronary artery disease was associated with significant improve- ment in generic and disease-specific QoL measures. The physical and mental health scores improved within the first 12  months of PCI, and the frequency of angina was significantly reduced, which translated into improvements in physical limitations and QoL on the Seattle Angina Questionnaires. These results may help with clinical de- cision making on the role of PCI in the treatment of stable coronary artery disease.

Depression and anxiety are very common mental illness in all societies. Patients with coronary artery disease were found to have an increased cardiovascular morbidity and mortality when depression or anxiety was present. Some evidence has suggested that post-procedural mental illness may have an impact on the major cardiovascular events after PCI. Reduced positive affect was independently associated with a 1.5-fold increased risk of all-cause mortality 7  years post-PCI.8 The prevalence and clinical significance of de- pression or anxiety in patients with stable coronary artery

disease treated with PCI are not clear. In the present study, depression and anxiety were found in 7.5% and 6.3% of the patients, respectively, prior to PCI. After PCI, there was a significant increase in the Zung anxiety scores and the pro- portion of patients who met the criteria for generalised anx- iety disorder 12  months after PCI within the control group. Further analysis in these patients revealed that the pre-PCI anxiety scores and low monthly incomes were associated with post-PCI anxiety symptoms. This is an important find- ing and supports research that has shown that mental disor- ders are associated with lower levels of income. Specifically, people with a household income of <$20  000 per year are at an increased risk of developing a mood disorder within 3  years, as compared to those with income of $70  000 or more per year.18 Furthermore, our results are supported by a recent study, where low levels of education and pre-proce- dural apprehension were some of the determining factors for post-procedural mental health disorders.19

The clarification of factors that determine post-PCI QoL has important clinical implications. A reduced frequency of angina is often associated with a better QoL after PCI.20 Other factors that are associated with a better post-procedural QoL are non-smoking status, cardiac rehabilitation,10 and lack of co-morbidities, such as heart failure.20 Depression compro- mises the QoL following PCI.20 In the present study, age, sex, level of education, monthly incomes, co-morbidities, location

Baseline 12 mo

Intervention Control Intervention Control

Seattle Angina Questionnaire (SAQ)

Angina frequency 61.9 ± 7.2 60.2 ± 6.0 96.9 ± 4.1 97.6 ± 5.2

Physical limitations 63.1 ± 8.6 62.9 ± 8.0 83.1 ± 6.0 72.0 ± 6.3*

Quality of life 40.1 ± 5.2 40.7 ± 4.8 83.6 ± 5.9 63.7 ± 4.9*

SAQ angina frequency (%)

Daily 12 (30.0) 10 (25.0) 0 0

Weekly 19 (47.5) 24 (55.0) 0 0

Monthly 9 (22.5) 6 (12.5) 1 (2.5) 1 (2.5)

SF-12 scores

Mental health scores 43.6 ± 8.1 40.9 ± 6.6 79.4 ± 5.1 54.1 ± 4.4**

Physical health score 39.7 ± 8.1 40.6 ± 7.9 81.6 ± 4.4 55.3 ± 5.9**

Zung self-rating scales

Depression scores 44.1 ± 7.2 45.7 ± 8.0 24.5 ± 2.8 47.0 ± 6.5

Depression scores > 59 (%)

3 (7.5) 3 (7.5) 1 (2.5) 3 (7.5)

Anxiety scores 38.6 ± 5.7 36.0 ± 4.1 18.9 ± 5.8 47.1 ± 6.9*

Anxiety scores > 45 (%)

2 (5.0) 3 (7.5) 1 (2.5) 9 (22.5)*

*P < .01 compared to intervention group. **P < .05 compared to intervention group.

T A B L E 2 Quality of life measures of the 80 patients at baseline and 12 mo after percutaneous coronary intervention

130 | CHANG et Al. and severity of coronary lesions were not associated with the post-procedural measures for QoL. However, the post-PCI anx- iety scores were inversely correlated with the generic and dis- ease-specific measures for QoL, indicating anxiety may have a negative impact on the QoL in patients treated with PCI for stable coronary artery disease.

An important finding in this study is that brief psychologi- cal counselling by trained nurses the day before and after PCI was associated with a significantly reduced anxiety scores, and higher scores of qualities of life measures. These data indicate that integration of psychological intervention into pre- and post-PCI care may improve patient’s mental health following the procedure, particularly in those patients of a low socio-economic background.

This study was limited by the small number of partici- pants, limited to a single geographical area. Future studies are required to refine the intervention protocol, and to extend to other rural and remote populations without regular access to ongoing pre- and post-rehabilitation services. Furthermore, we were unable to determine why more males were referred to our service, however we suspect it is because these rural male populations have increased cardiovascular disease risk factors, such as smoking. However, future research will need to determine why more males are referred for PCI in this pop- ulation setting.

5 | C O N C L U S I O N In this randomised controlled study, we have found that in pa- tients with stable coronary artery disease, PCI elicits a signif- icant improvement in QoL, with reduced angina frequency, and increased physical and mental well-being. However, there is also a significant increase in anxiety symptoms fol- lowing PCI, and these symptoms were negatively correlated with the scores of qualities of life measures. A nurse-led, brief psychological intervention before and after PCI was as- sociated a reduction in anxiety scores and improvement in quality of life measures. These data suggest that a greater effort should be made in screen for mental health disorders, such as anxiety, before PCI. Brief psychological intervention before and after PCI may further improve the outcomes in patients with stable coronary artery disease.

O RC I D Fergus W. Gardiner  https://orcid. org/0000-0001-7592-832X Le-xin Wang  https://orcid.org/0000-0002-9760-7436

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How to cite this article: Chang Z, Guo A, Zhou A, et al. Nurse-led psychological intervention reduces anxiety symptoms and improves quality of life following percutaneous coronary intervention for stable coronary artery disease. Aust J Rural Health. 2020;28:124–131. https ://doi.org/10.1111/ajr.12587https://doi.org/10.1111/ajr.12587

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