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Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV Gabriela Lima de Melo Ghisi* , Nicole Sandison, Paul Oh Cardiovascular Prevention and Rehabilitation Program, University Health Network,Toronto, Canada

A R T I C L E I N F O

A B S T R A C T

Article history: Received 28 August 2015 Received in revised form 3 November 2015 Accepted 3 November 2015

Objective: To develop, pilot test and psychometrically validate a shorter version of the coronary artery disease education questionnaire (CADE-Q), called CADE-Q SV. Methods: Based on previous versions of the CADE-Q, cardiac rehabilitation (CR) experts developed 20 items divided into 5 knowledge domains to comprise the first version of the CADE-Q SV. To establish content validity, they were reviewed by an expert panel (N = 12). Refined items were pilot-tested in 20 patients, in which clarity was provided. A final version was generated and psychometrically-tested in 132CR patients. Test-retest reliability was assessed via the intraclass correlation coefficient (ICC), the internal consistency using Cronbach’s alpha, and criterion validity with regard to patients’ education and duration in CR. Results: All ICC coefficients meet the minimum recommended standard. All domains were considered internally consistent (a > 0.7). Criterion validity was supported by significant differences in mean scores by educational level (p < 0.01) and duration in CR (p < 0.05). Knowledge about exercise and nutrition was higher than knowledge about medical condition. Conclusion: The CADE-Q SV was demonstrated to have good reliability and validity. Practice Implications: This is a short, quick and appropriate tool for application in clinical and research settings, assessing patients’ knowledge during CR and as part of education programming. ã 2015 Published by Elsevier Ireland Ltd.

Keywords: Coronary artery disease Patient education Health knowledge Attitudes Practice Questionnaires Psychometric validation

1. Introduction Cardiovascular diseases (CVDs) are the leading cause of mortality worldwide, and are a significant contributor to morbidity and health-related costs [1]. For persons with coronary artery disease (CAD), secondary prevention strategies (e.g. cardiac rehabilitation; CR) are highly effective to promote behavior change, but multi-factorial, necessitating patient awareness and adherence to optimize health outcomes [2–5]. Thus, the long-term success of CR rests in part on the patient's ability to maintain health behaviors, including participation in regular physical activity, following the end of the program [6,7]. Therefore, patient education is an essential part of the rehabilitation of CAD patients

* Corresponding author at: University Health Network—Toronto Rehabilitation Institute, Cardiovascular Prevention and Rehabilitation Program, 347 Rumsey Road, Toronto, Ontario M4G 1R7, Canada. Fax: +1 416 425 0301. E-mail addresses: [email protected], [email protected], [email protected] (G.L.M. Ghisi).

targeting self-management behavior to reduce risk factors and subsequent cardiac events [5]. Patient education has been formally defined as “the process by which health professionals and others impart information to patients that will alter their health behaviours or improve their health status” [8]. American and Canadian Cardiovascular Societies include patient education as a quality indicator of CR [9,10]. Findings from meta-analysis provide evidence of the effectiveness of patient education in CAD patients, in improving self-management behaviors [6,7,11], health-related quality of life, and potentially reducing healthcare costs [12] and recurrence of acute events [11]. Thus, a recent systematic review demonstrates the benefits of educational intervention in CHD, through increase in patients’ knowledge and behavior change (physical activity, dietary habits, and smoking cessation) [5]. In this context, the coronary artery disease education questionnaire (CADE-Q) was previously developed and psychometrically validated to assess patients’ knowledge about CAD in Brazilian CR patients [13]. It was later translated, cross-culturally adapted, and psychometrically validated to English [14]. It has also being used to

http://dx.doi.org/10.1016/j.pec.2015.11.002 0738-3991/ ã 2015 Published by Elsevier Ireland Ltd.

Please cite this article in press as: G.L.M. Ghisi, et al., Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV, Patient Educ Couns (2015), http://dx.doi.org/10.1016/j.pec.2015.11.002

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compare knowledge between a developed and a developing country [15]. Although both versions demonstrated good reliability and validity, the CADE-Q presented lack of detailed assessment of all core components of cardiac rehabilitation (CR), such as nutrition and psychosocial risk. Therefore, a second version (CADEQ II) was developed and validated in English [16]. However, both tools take around 20 min to complete and there was a need for a short and quick instrument to assess CR patients’ knowledge easier in clinical practice. The aim of this study was to develop, pilot test and psychometrically validate a shorter version of the CADE-Q, called CADE-Q SV. 2. Methods 2.1. Design and procedure This study was reviewed and approved by the University Health Network Ethics Board. The design consisted of a series of crosssectional, observational studies. First, based on previous versions of CADE-Q [13,14,16] a first version of the questionnaire was developed. This phase involved experts in each one of the 5 knowledge domains that the tool was structured around. A committee of 12 health providers and researchers who were experts in CR then reviewed this first version. They performed a content analysis, verifying if the new instrument was appropriate for administration in a CR population. Items were refined based on this review. Second was a pilot study to verify the applicability of the CADEQ SV, and to evaluate patient understanding of the items (clarity). Here a convenience sample of coronary patients that finished their CR programs and had previously-agreed to be contacted about research opportunities were recruited. Results were used to further refine the questionnaire. Third, a psychometric validation was performed. The refined tool was administered to a larger sample of current CR participants. The questionnaire was re-administered two weeks after the first application in 50 randomly selected participants to assess testretest reliability. Data were collected between July and August of 2015. 2.2. Participants For the pilot test, graduates of the Toronto Rehabilitation Institute CR program (Toronto, Canada) were surveyed. For the psychometric-validation, a convenience sample of current CR patients from the same institution was recruited. This program is 6 months in duration and patients were recruited from all classes. The sample size calculation for the psychometric analysis was based on Hair & Anderson [17] recommendation of a sample size of 5 subjects per item, and/or at least 100 participants. The inclusion criteria were the following: confirmed coronary artery disease diagnosis or multiple cardiovascular risk factors (such as hypertension and diabetes). The exclusion criteria were the following: younger than 18 years old, lack of English-language proficiency, any significant visual or cognitive condition or serious mental illness which would preclude the participant's ability to answer the questionnaire. 2.3. Measures To assess clarity, pilot study patients were asked to rate each item on a Likert-type scale [18] ranging from 1 (not clear) to 10 (very clear). Time to complete the questionnaire was also assessed during this phase of the study.

CR participants from the psychometric-validation were characterized according to sex, age, educational level, comorbidities, cardiac risk factors and history, and duration of participation in CR. All characteristics were self-reported. 2.4. Statistical analyses SPSS Version 22.0 (IBM Inc 2013, NYC) was used for entering, cleaning and analyzing the data and the level of significance was set at 0.05 for all tests. Where more than 10% of the items were missing, the data were excluded from further analysis. To test the psychometric properties of the new tool, we investigated reliable measures of each one of the knowledge domains. The first analysis was test-retest reliability, assessed through the intraclass correlation coefficient (ICC). If bad items were found they were eliminated [19]. We then proceed to internal consistency analysis of each area by Cronbach’s alpha. For this analysis, values higher than 0.70 were considered acceptable, reflecting the internal correlation between items of the same area [17]. The factor structure was an option of assessment if the internal correlation between items in the areas was not confirmed. Criterion validity was also assessed by comparing CADE-Q SV total scores by participant’s level of education and duration in CR, using t-tests and Pearson’s correlation respectively. Item completion rates were also described. Finally, a descriptive analysis of the CADE-Q SV was performed. A mean total score was computed to reflect total knowledge. Ttests, one-way analysis of variance and chi-square tests were used as appropriate to assess differences in total knowledge based on patient’s socio-demographic and clinical characteristics. 3. Results 3.1. Participants characteristics For the first phase (expert’s review), there were 10 (85%) clinicians, and 2 (15%) researchers who reviewed the items. For the pilot test, 30CR graduates who agreed to be contacted were contacted. Twenty (67%) responded, of which 8 (40%) were female, with a mean age of 66.7  3.4 years old. For the psychometric validation study, 200 coronary patients participating in CR (representing approximately 20% of total annual CR patients) were approached to participate in this study during the recruitment phase. One hundred and thirty two (66%) participants signed the consent form and completed the CADE-Q SV. The characteristics of these participants are presented in Table 1. To assess test-retest reliability, 50 of these participants were randomly selected and asked to complete the CADE-Q SV twice, in an interval of 2 weeks. 3.2. Development of the tool Based on previous versions of CADE-Q [13,14,16] the first version of the CADE-Q SV was developed. Experts in each area of knowledge—medical condition, risk factors, exercise, nutrition, and psychosocial risk—reviewed each area and defined the questions that should be included based on patients’ information needs, importance and education guidelines. Overall, all statements were based on the CADE-Q II. The CADE-Q SV was designed to be a true/false/I do not know questionnaire, with 20 items (4 in each domain). Each correct answer equals to 1 point; therefore, the maximum score possible is 20 overall, 4 by domain, and 1 per item. The first version was reviewed by a committee of CR experts, who concluded that all items were appropriate for administration in a CR population and no changes were made in the scale at this phase.

Please cite this article in press as: G.L.M. Ghisi, et al., Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV, Patient Educ Couns (2015), http://dx.doi.org/10.1016/j.pec.2015.11.002

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Table 1 Sociodemographic/clinical characteristics of the participants for the psychometric validation and CADE-Q SV mean scores and differences among subgroups (N = 132). Characteristic Sociodemographic Age (mean  SD) Sex n (%) Educational level n (%)

Clinical Risk factors n (%)

Comorbidities n (%)

CADE-Q SV Score (mean  SD) Male Female Elementary school High school College University Postgraduate Hypertension Dyslipidemia Smoking history Heart failure Diabetes mellitus type I Diabetes mellitus type II Peripheral arterial disease Chronic obstructive pulmonary disease

Myocardial infarction n (%) Coronary bypass n (%) Angioplasty n (%) Duration in CRa (mean  SD) 1 2 3 4 5 6

month months months months months months

66.33  10.32 92 (69.7%) 40 (30.3%) 9 (7.0%) 27 (20.9%) 23 (17.8%) 39 (29.5%) 31 (24.0%) 73 (55.3%) 58 (43.9%) 26 (19.7%) 13 (9.8%) 1 (0.8%) 30 (22.7%) 8 (6.1%) 2 (1.5%) 46 (34.8%) 27 (20.5%) 49 (37.1%) 2.70  1.63 33 (31.1%) 25 (23.6%) 18 (17.0%) 8 (7.5%) 15 (14.2%) 7 (6.6%)

p

16.51  2.28 16.48  1.84 14.22  3.73 15.78  1.78 16.74  1.48 16.28  2.46 17.03  1.43

0.93

16.49  2.22 16.59  1.77 16.54  2.55 16.92  1.61 11.00  0.00 16.80  1.75 16.50  2.20 16.50  0.71 16.50  2.35 16.78  1.76 16.59  1.77

0.97 0.68 0.92 0.47 0.06 0.39 1.00 1.00 1.00 0.45 0.71

13.15  1.75 13.68  1.57 14.60  1.73 16.63  2.00 16.00  3.16 16.43  1.72

0.02*

0.009**

SD = standard deviation. Significant differences between groups: *p < 0.05; **p < 0.01. a Maximum duration of the CR program is 6 months.

3.3. Pilot testing The 20 participants took a mean of 7  2 min to complete the CADE-Q SV. Clarity ratings are shown in Table 2: mean clarity of the items was 9.10  1.12 and no items had mean clarity scores lower than 7. These results indicated that the target population understood the questionnaire. 3.4. Psychometric validation CADE-Q SV mean scores per item and domain are shown in Table 2. Item completion rates are also shown in Table 2. The test-retest reliability was evaluated through the intraclass correlation coefficient (ICC) for each item, and all coefficients meet the minimum recommended standard (therefore, no items were eliminated). After that, the reliability of each area was assessed by Cronbach’s alpha. All areas were considered internally consistent (a > 0.7). Table 2 displays Cronbach’s alpha of each area. With regard to criterion validity, total CADE-Q SV scores were compared by education level and by duration in CR. As shown in Table 1, patients with lower educational level had significantly lower knowledge than those with higher education (p < 0.01). Regarding duration in CR, there was a correlation between this characteristic and knowledge (r = 0.13; p < 0.05): patients in the first 3 months of the program had significantly lower knowledge compared to patients finishing the program (5–6 months of duration). 3.5. Descriptive analysis of knowledge The mean total score was 16.50  2.15. Besides educational level and participation in CR (reported previously) no differences were found in mean CADE-Q SV scores by other patients’ sociodemographic and clinical characteristics.

Means and standard deviations of each item are reported in detail in Table 2. The statements with higher scores were the following: “Examples of risk factors for heart disease that can be changed are: blood pressure, cholesterol, smoking and second hand smoking, waist size, and reaction to stress” (0.98  0.15), “To control blood pressure, one should lower the amount of sodium in the diet to less than 2000 mg per day, exercise, take blood pressure medication regularly (if prescribed), and learn relaxation techniques” (0.95  0.23), and “The benefits of resistance training (lifting weights or using elastic bands) include: increasing strength, improving the ability to carry out day to day activities, improving blood sugar levels and increasing muscle mass” (0.95  0.21). Regarding the 5 areas of the questionnaire, exercise and nutrition were the areas with the greatest knowledge; and medical condition was the one with the lowest knowledge. Mean and standard deviation of each area are also reported in Table 2. 4. Discussion and conclusion 4.1. Discussion Education is a core component of CR, and is necessary to promote patient understanding of secondary prevention strategies and adherence to these strategies. Herein, this study sought to develop, pilot test and validate the CADE-Q SV, a shorter and more practical version to assess CR patients' knowledge about their condition and related factors. Internal reliability, test-retest reliability, content and criterion validity were all established, and demonstrate the utility of this questionnaire. When a new version of a questionnaire is developed it should not only be updated, and better on theoretical basis, but must also be shown to be at least as good as the original instrument in terms of validity and reliability. In this context, results of the

Please cite this article in press as: G.L.M. Ghisi, et al., Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV, Patient Educ Couns (2015), http://dx.doi.org/10.1016/j.pec.2015.11.002

Clarity Rating by Pilot study patientsa Mean  SD

CADE-Q SV score per itemb Mean  SD

CADE-Q SV item completion rates

CADE-Q SV score per domain Mean  SD

%

2.72  0.66

100%

Cronbach’s alpha per domain

Domainc

Item

Medical condition

1. Coronary Artery Disease is a disease of the arteries in the heart, which only happens in older people who have high 9.45  0.20 cholesterol or smoke. 3. “Angina” is chest pain or discomfort, at rest or during physical activity, which can be felt in the arm, back and/or 9.55  0.70 neck. 6. Anti-platelet medications such as aspirin (ASA) are important because they lower the “stickiness” of platelets in the 9.10  0.77 blood, which helps blood flows more easily through coronary arteries and past coronary stents. 11. The “statin” medications limit how much cholesterol the body absorbs from food. Statin medications include 7.70  0.76 atorvastatin (LipitorTM), rosuvastatin (CrestorTM), or simvastatin (ZocorTM).

0.89  0.31

9.45  1.25

0.98  0.15

9.70  0.35

0.95  0.23

100%

8.70  1.17 8.40  0.39

0.87  0.34 0.67  0.47

99.2% 99.2%

4. The benefits of resistance training (lifting weights or using elastic bands) include: increasing strength, improving 9.45  0.25 the ability to carry out day to day activities, improving blood sugar levels and increasing muscle mass. 8. An exercise warm-up slowly increases heart rate and can lower the risk of developing angina. 9.30  0.54 13. If someone gets chest discomfort during a walking exercise session, he or she should speed up to see if the 9.500.71 discomfort goes away. 17. Someone knows if he or she is exercising at the right level when the heart rate is in the target zone, the exertion 9.15  0.19 level is no higher than “somewhat hard”, and he or she can exercise and talk at the same time.

0.95  0.21

Nutrition

5. Eating more meat and dairy products is a good way to add more fibre to one’s diet. 9. Prepared, processed foods usually have high sodium content. 14. Trans fats are partially hydrogenated vegetable oils (e.g. vegetable shortening) and are unhealthy. 20. A diet that can help lower blood pressure is rich in: vegetables and fruits, whole grains, low fat dairy, nuts and seeds.

8.80  0.70 9.65  0.78 9.60  0.48 9.65  0.10

0.91  0.29 0.95  0.23 0.84  0.37 0.92  0.27

3.61  0.55

100% 99.2% 100% 99.2%

0.84

Psychosocial risk

7. The only effective strategy to manage stress is to avoid people who cause unpleasant feelings. 7.00  1.40 10. Depression is common after a heart attack. Depression can lower one’s energy level for rehab and increases the 9.40  1.12 risk of another heart attack. 15. Sleep apnea that is not treated increases the risk for another heart attack, but it does not increase risk of death. 8.95  0.56 19. Stress is a large risk for heart attack and is as important as high blood pressure and diabetes. 9.10  1.12

0.86  0.35 0.88  0.33

3.11  0.84

100% 100%

0.91

Risk factors

Total

SD = standard deviation. a Clarity rating raging from 1 = not clear and 10 = very clear. b CADE-Q SV scores raging from 1 = correct; 0 = incorrect or I do not know. c Maximum score per domain = 4.

98.5%

0.90  0.30

98.5%

0.10  0.30

100%

3.47  0.74

3.58  0.69

99.2%

99.2%

0.86  0.35 0.930.25

98.5% 99.2%

0.84  0.37

99.2%

0.52  0.50 9.60  1.12 16.50  2.15

0.86  0.34 –

98.5% 97.7% 99.3%

0.79

0.76



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Exercise

2. Examples of risk factors for heart disease that can be changed are: blood pressure, cholesterol, smoking and second hand smoking, waist size, and reaction to stress. 12. To control blood pressure, one should lower the amount of sodium in the diet to less than 2000 mg per day, exercise, take blood pressure medication regularly (if prescribed), and learn relaxation techniques. 16. To control cholesterol, one should become a vegetarian and avoid eggs. 18. Diabetes cannot be prevented with exercise and healthy eating.

0.83  0.38

0.94

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Please cite this article in press as: G.L.M. Ghisi, et al., Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV, Patient Educ Couns (2015), http://dx.doi.org/10.1016/j.pec.2015.11.002

Table 2 Mean and standard deviation of clarity rating by pilot study patients (N = 20), CADE-Q SV score per item and domain (N = 132), CADE-Q SV item completion rates, and Cronbach’s alpha per domain.

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CADE-Q SV were consistent with those presented in previous versions of this instrument [13,14,16], particularly in relation to criterion validity (correlation to educational level) and all areas being considered internally consisted (a > 0.70). The overall mean, as well as the means of the areas were high, reinforcing the idea that CR patients are knowledgeable of the information that is important for them. It may also suggest that individuals with low socioeconomic levels or low literacy are not participating in these programs and strategies to eliminate barriers to access CR should be implemented [20]. There are some limitations to this study, which should be stated. There are some elements of the scale, which require further assessment. First, future research is needed to assess whether the scale is sensitive to change, such as following participation in CR, or to test implementation of new education materials. Second, whether the CADE-Q SV is a valuable and valid tool to identify knowledge differences in non-CR patients should be explored. 4.2. Conclusion In conclusion, the CADE-Q SV proved to have strong psychometric properties, providing preliminary evidence of its reliability and validity to assess CR patients’ knowledge. It is hoped this tool can support CR programs to evaluate their patients’ knowledge in clinical practice and promote greater provision of information consistent with patients’ educational needs. 4.3. Practice Implications The availability of a short and quick version to assess CR patients’ knowledge is essential in clinical and research settings, assessing patients’ knowledge during CR and as part of education programming. Clinical and educational practice can be enhanced or changed using findings from questionnaire-based methods and CADE-Q SV is hoped to be an option for this purpose.

Conflict of interest Authors declares there are no conflict of interest. Role of funding Authors declares there are no role of funding. Patient/personal identifiers statement I confirm all patient/personal identifiers have been removed or disguised so the patient/person(s) described are not identifiable and cannot be identified through the details of the story.

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Please cite this article in press as: G.L.M. Ghisi, et al., Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV, Patient Educ Couns (2015), http://dx.doi.org/10.1016/j.pec.2015.11.002

Development, pilot testing and psychometric validation of a short version of the coronary artery disease education questionnaire: The CADE-Q SV.

To develop, pilot test and psychometrically validate a shorter version of the coronary artery disease education questionnaire (CADE-Q), called CADE-Q ...
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