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European Journal of Heart Failure 2003 5(6):783-791; doi:10.1016/S1388-9842(03)00158-2
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© 2003 European Society of Cardiology

Instruments to measure acceptability of information and acquisition of knowledge in patients with heart failure

Femida Gwadry-Sridhara,b, Gordon H. Guyatt*, J.Malcolm O. Arnolda, David Massela, Jim Browna, Lorraine Nadeaua and Sharon Lawrencea

a Division of Cardiology, London Health Sciences Centre London, Canada
b Clinical Epidemiology and Biostatistics, HSC-2C12, McMaster University Medical Centre 1200 Main Street West, Hamilton, ON, Canada, L8 N 3Z5

* Corresponding author. Tel.: +1-905-525-9140x22900; fax: +1-905-524-3841 E-mail address: fsridhar{at}sympatico.ca


    Abstract
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 
Background: Patients with heart failure suffer from poor health outcomes and require combinations of medications to treat their disease. Providing patients with knowledge through education is one mechanism to help them improve compliance with complicated treatment regimens.

Methods: We developed and tested two instruments. The first instrument, which we call the measure of educational material acceptability (EMA), was designed to help us differentiate between written educational materials according to patients’ subjective responses. The second instrument, the knowledge acquisition questionnaire (KAQ), which measures knowledge gained, was designed to determine whether patients understand the rationale and mechanics of their heart failure management. We explored the measurement properties of both instruments.

Results: The internal consistency of the EMA was 0.79 (Cronbach's alpha). The internal consistency of the KAQ was 0.61 and its responsiveness, measured using change scores of knowledge before and after an educational intervention, was 0.75.

Conclusions: We have developed instruments that measure acceptability and knowledge acquisition, and that clinicians and investigators involved in heart failure programs may find useful in developing educational material and measuring the impact of their interventions on patients’ knowledge.

Key Words: Educational material acceptability (EMA) • Knowledge acquisition questionnaire (KAQ) • Health decision making theory (HDMT)

Received May 14, 2002; Revised April 23, 2003; Accepted June 17, 2003


    1. Introduction
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 
Chronic disease states are complex and multidimensional requiring multi-faceted interventions to improve clinical outcomes and quality of life. Typically, people with chronic disease face a high risk of adverse outcomes such as poor functional status, impaired quality of life and premature death. This is particularly true of patients with heart failure, whose management requires dietary and fluid restrictions, exercise prescriptions and the use of multiple medications [15]. Patients who do not follow diet and medication instructions suffer an increased rate of morbid events and sub-optimal outcomes [610].

Patients who misunderstand their diagnosis and treatment plans may use their medication sub-optimally [11]. There are many reasons why people do not use their medications as prescribed. An established theoretical framework, Health Decision Making Theory (HDMT) [12] provides some insight into patient non-compliance. One of the determinants of medication use, HDMT posits, is the direct or indirect experience that patients, or their friends or family, have with medications. Patients also have varying perceptions about the potential usefulness of medications and the impact of the drugs’ effects on their lives. Ultimately, a number of complex interactions between patients and their physicians, other health care providers or information they receive from various sources will influence their behaviour [13].

While the HDMT provides reasons why people don't comply, improving compliance requires a model to guide the development of interventions. One such model, the Health Education Model [14], is based on the premise that knowledge is fundamental to the decision-making process of behaviour choice by helping people weigh the costs and benefits [1517]. The Health Education Model framework constitutes a first step in dealing with the issues related to non-compliant behaviour [18].

Ensuring optimal knowledge acquisition requires that educational material be understandable and appealing to patients, and that clinicians need to measure the extent to which patients have integrated their educational messages. In preparation for a controlled clinical trial of a knowledge enhancing intervention we designed (1) a measure of patient satisfaction with educational material, the educational material acceptability (EMA) instrument; and (2) a measure of knowledge of the management of heart failure, the knowledge acquisition questionnaire (KAQ). In this paper, we describe the development of both instruments and how we tested their measurement properties.


    2. Methods
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 
This study was conducted in a University affiliated hospital, the London Health Sciences Centre, London, Canada, Victoria Campus in patients hospitalized with heart failure as a primary or secondary diagnosis as the reason for admission. The research team consisted of three cardiologists, one nurse practitioner, one hospital pharmacist, one Ph.D. student and two research assistants. The investigation conformed with the principles outlined in the Declaration of Helsinki.

2.1. Selection of relevant information for educational intervention
To enhance patient understanding of their illness, and its optimal management, it was first necessary to develop and select appropriate educational interventions. The research team developed, by consensus, a list of minimal information detailing specific issues relevant to both healthy lifestyle and medication use that patients should know with respect to their disease, diet and medical treatment [3] (Table 1). Commercially available, commonly used educational materials, written in English, were requested from other hospitals, Foundations and Canadian based pharmaceutical companies. We evaluated these materials and found that no ones booklet met the predefined minimal criteria. Thus, we selected three candidates heart failure booklets that we felt best matched our criteria [19,20].


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Table 1 Minimal content of education for heart failure patients

 
2.2. Development and testing of the measure of educational material acceptability (EMA)
During the development process we met with educators in the University of Western Ontario (UWO) Department of Family Medicine to review the instruments they used to measure acceptability of their educational materials for patients. Our research team revised the instruments to be more applicable to our patient population. Domains that we incorporated in the EMA included: clarity, accuracy, content, reading level and technical quality. The response options in this multi-item instrument used a five-point scale ranging from strongly disagree (1) to strongly agree (5). We chose a five-point scale to facilitate patient response and to reduce the burden to the patient [21].

Firstly, we conducted a pilot test in a cohort of heart failure patients and their spouses (n=13) admitted to the medicine and cardiology floors of our hospital, and in the Independent Senior's Research Group of lay people (n=5) affiliated with UWO. They tested the acceptability measure by rating three Heart Failure booklets. The booklets could be read in any order. The hospital inpatients and spouses were given a maximum of 24 h to read the booklets and answer the questions and the Seniors’ group were given 1 week to review and mail back the information. The patients and the Seniors’ Research Group were asked to reflect on the measure itself and provide us with written and verbal feedback on clarity and wording of the questions. The instrument was modified accordingly. Ultimately, we included two questions in each domain, for a total of 10 questions (Appendix A).

Secondly, the measurement properties of the final 10-item EMA were determined by giving the booklets and questionnaires to every fifth hospital patient, with an admission diagnosis of heart failure, or other cardiac disease (n=21), who provided verbal consent. The patients were identified as they appeared on a daily admissions list generated by the health records department. We included patients who provided verbal consent and had any cardiac disease including heart failure.

2.3. Development and testing of the knowledge acquisition questionnaire (KAQ):
We specified that the instrument to measure knowledge had to be multidimensional with each dimension representing a specific aspect of the educational process related to each of the minimal criteria used in selecting the education (Table 1). Thus, the questionnaire incorporated core areas of knowledge that would provide patients with the minimum information required to avoid preventable complications. Constraints that were imposed on the design of the questionnaire included suitability for self-administration and a length that would not create an excessive burden in this elderly population. Prior to presenting this to patients, we ensured readability at a grade 8 level by using commercially available specialized software. (Right Writer 3.1 version RIGHT SOFTTM 1988).

Firstly, we circulated the questionnaire to nurses, pharmacists, study personnel and physicians at our hospital. Respondents (n=10) commented on the readability and face validity of the questionnaire. We refined the questionnaire based on the feedback from the health providers. Secondly, we pilot tested the questionnaire, which at this point consisted of 18 questions, in 30 patients who were in hospital with heart failure, taking medical therapy, had no language barriers or dementia and provided verbal consent. A letter of information outlining the pilot was given to each patient and verbal consent was obtained. Patients completed a pre-test questionnaire, read the heart failure education booklets we had chosen, and completed a post-test (same questions as the pre-test in different order) within 24 h. Responses to the pre and post-tests were analyzed to further refine the questionnaire to maximize information gained. Questions that patients responded to correctly 80% of the time in both tests were deleted, as these questions would not help distinguish between patients according to knowledge gained. Eight such questions were deleted reducing KAQ to 11 questions that resulted in a maximum of 14 marks as multiple choice questions with multiple answers were given part marks and questions related to demographics were not given any marks (Appendix B).

Thirdly, we conducted a randomized controlled trial approved by UWO Institutional Review Board, in patients who were admitted to any ward in the hospital, over a 15-month period, and had a clinical diagnosis of heart failure. They were stratified by reason for admission (with heart failure as the primary or secondary reason for admission) and then randomized to receive ‘usual care’ (Control) or ‘enhanced care’ (Intervention). Patients in the Control arm received booklets on heart failure management. Any information that was generally available through the wards was not censured. Patients in the Intervention arm received the same educational booklets plus personalized feedback teaching over 48 h with a research team consisting of an educator and a pharmacist. The educator focused on discussions related to dietary management, exercise and health promotion. The pharmacist then reviewed the drugs that the patient was going receive on discharge. An innovative visual aid, that the pharmacist made, explicitly showed the patient the anatomy of the heart, the pump mechanism and described how the prescribed medication benefited heart function. Verbal and written information about the potential benefits and side-effects of the prescribed medications were provided and a customized medication calendar was developed. Patients received the pre-test prior to randomization and the post-test within 24 h following completion of teaching.


    3. Statistical methods
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 
3.1. Patient rating of booklets
3.1.1. Acceptability
Each of the 10 items of the EMA were assessed using a repeated measures analysis of variance across the three booklets analysed using SAS 6.12 (SAS Institute Inc., Cory, NC, USA). Where booklets differed in their acceptability with significant differences between mean scores (P<0.05), the items in question were compared using a multiple comparisons test (Tukey's test).

3.2. Pre-post tests of knowledge
3.2.1. Reliability and responsiveness
The internal consistency of the instrument was measured using Cronbach's alpha [20]. The formula for Cronbach's alpha is ‘{forall}={Phi}s2/{Phi}s2+{Phi}sx I2/6, where ({Phi}s2) is the variance of the scores and ({Phi}sxi2) is the variance attributable to the subject and item and (6) is the number of items. For the pre-test and post-test KAQ questionnaires, the object of the measurement was the patient. Reliability was calculated pooling all patients from the control and intervention arms who received the pre-test and post-test. The SPSS statistical package 10.0 was used for these analyses (SPSS Inc., Chicago, IL).

Responsiveness refers to the ability of the instrument to detect changes in patient status, even if those changes are small. Responsiveness was calculated using the change in score from post-test to pre-test divided by the standard deviation of change post–pre-test score/SD change [22].

3.2.2. Validity
Content validity and face validity of the questionnaire were determined by the process of peer-review with members of the Heart Failure Team, and review by healthcare providers and members of the senior's independent research group

Construct validity considered the correlation between the dependent variable, which was the post-test score, and each of the following independent variables: patient age, reason for admission, baseline compliance and baseline pre-test score. We hypothesized that older people would score lower than younger people and that patients with pre-existing heart failure prior to the index admission would score higher. Computing a Pearson correlation coefficient using SPSS 10.0 tested these discriminating properties between various patient groups.


    4. Results
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 
4.1. Properties of the measure of educational material acceptability (EMA)
Rating of Booklets was performed on 21 patients. For the 10-item EMA instrument, scores from the three booklets were similar on seven out of ten items. For three items, significant differences were found (Table 2) suggesting that booklet 2 was better received than either booklet 1 or 3. Although there were no significant differences between booklets 1 and 3 there appeared to be a trend in favour of booklet 1. The internal consistency of the EMA using Cronbach's alpha was 0.79.


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Table 2 Patient (n=21) ratings (scale 0–5) of booklets by statement that differed across booklets

 
4.2. Patient characteristics
Table 3 presents the demographics of the 126 patients participating in the randomized controlled trial who received the pre- and post-test KAQ instrument. Patient characteristics were determined at the time of the index hospital admission. Measurement of LVEF was generally obtained at baseline and estimated using either echocardiography or left ventriculography at the time of cardiac catheterization. If the LVEF was not done at the time of the index admission it was included if performed within six months of the admission. The mean age was 66 years. The majority of subjects were male, had CHF as the secondary diagnosis and had severe left ventricular systolic dysfunction.


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Table 3 Baseline patient characteristics

 
4.3. Properties of the knowledge acquisition questionnaire
Internal consistency measured by Cronbach's alpha was 0.61 in the pre-test and 0.66 in the post-test. The responsiveness of the instrument was 1.74/2.33=0.75. The pre- and post-mean scores by randomization arm are shown in Table 4. The pooled mean scores by randomization arm are shown in Table 5.


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Table 4 Pooled mean KAQ scores by treatment group

 


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Table 5 Pooled scores for pre- and post-test

 
The questions that patients consistently answered incorrectly, primarily in the control group, were related to salt intake and recognising shortness of breath as a symptom of worsening heart failure. Overall 22% of patients answered incorrectly on each of the above questions.

4.4. Construct validity
Construct validity was using correlations between variables (Pearson correlation coefficient r) was not found to be statistically significant for the variables shown in Table 6.


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Table 6 Pearson correlation coefficients for patient variables

 

    5. Discussion of results
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 
Ascertaining the acceptance and usefulness of educational materials requires the ability to measure (1) the patient's perception (acceptability) of the material; and (2) measure knowledge gained (acquisition) as a result of the educational interventions. A search of the literature through Medline, PubMed and the Cochrane Library yielded no published instruments for patients with heart failure to measure either the acceptability of educational materials or patient knowledge about diet and medications.

We have developed instruments that help health care practitioners (1) determine from which educational interventions patients get the most information; and (2) provide a measure of how well the intervention contributes to patient knowledge about their disease and compliance with dietary and medical prescriptions. The ability to evaluate an intervention formally can assist researchers in targeting information that is beneficial to the patient's outcome. Future developments might warrant the inclusion of questions that speak to quality care measures where one could address accountability of health care providers for the education provided as well as measure the quality of the program to ensure that certain minimal standards are met. Currently, the health care environment albeit focused on patient education has not taken the next step in ensuring that certain standards are met consistently.

5.1. Measuring acceptability of booklets (EMA)
The internal consistency of the EMA using Cronbach's alpha was 0.79 (a value >0.70 indicates good internal consistency). Three of ten statements that were part of the EMA differentiated between the three booklets. There was sufficient range (1–5) in the response to the other seven statements to suggest that they do provide valuable information and should be retained.

5.2. Testing knowledge gained
Our primary finding was that the KAQ instrument proved responsive (0.75). The ability of an instrument to detect change over time is necessary for the evaluation of educational programs. Our measure of reliability, Cronbach's alpha, was 0.66 using the post-test. This is not unexpected as Table 4 illustrates that the mean pre-test scores for both Intervention and Control were between 10.07 and 10.47 and following the intervention both groups benefited from the information they were provided, however, the Intervention arm benefited to a greater degree and may have reached a ceiling with their responses (S.D.±1.84). The Cronbach's alpha indicates that patients do not respond consistently and the instrument may be limited as an instrument for discrimination but is very useful as an evaluative instrument, measuring within-person changes.

The baseline scores on the pre-tests were between 10–10.5 out of a possible score of 14. One could argue that a possible limitation of the KAQ is the possible ceiling effect in patients who have been previously educated.

Generally, the higher the reliability, the higher the maximum possible validity [20]. A potential limitation of our study is that we did not find any relationship between the variables that we had hypothesized would be correlated with knowledge. We do not consider this a failure of the instrument. Rather, we interpret the results as suggesting limitations in our a priori hypotheses about the relationship between knowledge and other variables. Firstly, most of our patients tended to be older. Secondly, we had more patients with heart failure as a secondary reason for admission (74%) rather than the primary reason (26%). Thirdly, the fact that we did not see any correlation between the pre- and post-test suggests the importance of the knowledge patients received through our education. Where an intervention is unsuccessful we would expect strong correlation between a pre- and post-test. Our a priori hypothesis about potential relationships that we tested under construct validity was based on our perceptions, as the literature was conflicting. Perhaps, the lack of any relationship between knowledge and variables such as prior diagnosis points to an even greater problem with a lack of adequate knowledge in patients with heart failure irrespective of the length or severity of their disease. The failure of our hypothesis highlights the danger in making assumptions about patient's underlying knowledge.

We used the framework of the Health Education Model, positing the following causal steps: patients will hear, understand and learn information about their disease and the importance of being compliant which will subsequently lead to improved clinical outcomes. Our two new instruments may help providers utilize information that patients understand and evaluate the impact of such on knowledge.

We acknowledge that increased testing of the KAQ instrument by others would be valuable.

We were unable to generate a priori hypotheses about the relationship between changes in scores following an intervention and variables that should change in parallel, and thus did not test the longitudinal validity of the KAQ.

The strength of our work lies in (1) the development of an instrument to measure patient acceptability of education; (2) the careful development of the instrument to measure knowledge; (3) the testing of the knowledge instrument within a randomized controlled trial; and (4) the inclusion of patients with a wide range of left ventricular function.

The external validity of the KAQ is supported by comparing our cohort to other patients with heart failure in Canada. A recent study provides confidence in our assertion that the data can be generalized. Patients in this population-based cohort were similar to our patients with respect to mean age. Canada uses a single payer health care system that encompasses many geographically variable regions and socioeconomic strata [23]. Our eligibility criteria did not exclude patients with multiple comorbidities and we did not screen out older patients. This does not preclude the fact that there may be variations across North America to which we cannot generalize. We required patients or their caregivers had to be conversational in English.


    6. Conclusions
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 
Health care programs treating heart failure patients need instruments that help evaluate specific aspects of a program. The instruments we constructed to evaluate patient satisfaction with education and knowledge about their disease, health issues and medication before and after an intervention can be used by health care educators and researchers. Further, the KAQ's ability to measure knowledge gained will allow researchers to further explore the relationship between knowledge change, clinical outcomes and medication compliance.


    Appendix A
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 

Formula


    Appendix B
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 

Formula


    Acknowledgements
 
Merck Frosst Canada for an investigator initiated, unrestricted research grant that allowed the implementation of this study; Heart and Stroke Foundation Canada for salary support for FGS, the Department of Family Medicine (Dr C. Maclean) for sharing educational materials, UWO Seniors group, Gord Marchiori, Martha Calhoun and Dorothy Beattie for assisting with the data collection and input.


    References
 Top
 Abstract
 1. Introduction
 2. Methods
 3. Statistical methods
 4. Results
 5. Discussion of results
 6. Conclusions
 Appendix A
 Appendix B
 References
 

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