Effectiveness and Cost-effectiveness of an Empowerment-Based Self-care Education Program on Health Outcomes Among Patients With Heart Failure

Key Points Question What are the effectiveness and cost-effectiveness of a 12-week, empowerment-based self-care intervention on health outcomes and health care use among patients with heart failure? Findings In this randomized clinical trial of 236 patients with heart failure, when compared with didactic education, an empowerment-based self-care intervention was effective and cost-effective, resulting in improvement in symptom perception and response. Meaning These findings suggest that education using an empowerment approach is more effective than didactic methods to improve self-care and health outcomes of patients with heart failure.

Heart failure (HF) is a complex clinical syndrome resulting from inefficient myocardial pumping, and is commonly presented as the end manifestation of many cardiac diseases. Similar to other organ failure, HF is characterised by a 13 typical progressively deteriorating trajectory punctuated by serious episodes of acute disease decompensation. 1 The the sequence of block size to be used. For each chosen block size, the computer will then, randomly generate a 134 sequence of subject allocation between the intervention and control groups. Subjects chronologically recruited to the 135 study will be allocated to the study groups by the research nurse according to the computer generated sequence.

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SNOSE technique was used to keep the allocation concealment. The subjects was not informed of whether they 137 participated in the test intervention or control intervention.

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For the intervention group: the empowerment-based self-care education program Subjects in the intervention group had participated in a 12-week empowerment-based self-care program, which was delivered by a cardiac nurse who has a baccalaureate degree in nursing and at least 3 years of clinical experience in cardiovascular nursing. The program will comprise five weekly 90-minute face-to-face sessions in small groups of 145 4-5 patients, followed by three weekly and two bi-weekly telephone follow-ups. Group teaching was used because 146 the literature indicates patients appreciated the peer learning experience and its positive effect on improving 147 motivation in behavioral changes. 16 To enhance the fidelity of the study intervention, a User Manual (Additional conducting telephone follow-up care has been developed to guide the delivery of the intervention. The five face-to-face sessions was delivered in the specialist clinics, and cover five major topics in CHF 152 self-care, i) CHF manifestations and symptom monitoring, ii) dietary and fluid modification, iii) medication management, iv) recognition and management of deteriorated symptoms and v) activity and exercise. The educational content of each session complied with the international clinical guidelines and recommendations 155 published by the British Heart Foundation and American Heart Association. The content has been validated by a 156 multidisciplinary team that included cardiologists, an advanced practice nurse, nursing academicians in cardiologist, on international guidelines on CHF management and self-care, principles and skills in patient empowerment, and the methods used to deliver the study protocol.
Guided by empowerment-based philosophies in self-care education, each session will be incorporated with a five-step goal setting process to facilitate self-directed goal attainment. 12 on helping the patients to understand the link between the symptoms, the underlying mechanism of the disease, symptom exacerbation and realize the importance of the recommended self-care.

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3) The nurse helped the patients to identify their own self-care deficits by encouraging them to compare their usual 174 self-care practice with the recommended health information, and highlighted the associated health effect of 175 these behavioural discrepancies. After reflection, the nurse assisted the patients to set their self-care goals which 176 was documented on a goal attainment form. 177 4) Skill building is followed during which interactive teaching strategies, such as role play or scenario-based group 178 activities, will be used to enhance the patients' tactical and situational skills relevant to the topic of the session.

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The tactical skills focus on self-care skills in daily behaviours, while the situational skills focus on those 180 required in challenging situations (e.g., dietary compliance when eating out or during festivals). 20 181 5) The nurse encouraged the patients to discuss their feelings, concerns, perceived barriers and resources in 182 achieving their goals. Each patient then set up individualized action plan for goal attainment. Resource notes 183 relevant to the topic area in a concise writing style, with large-font print and visual depictions was provided to 184 enable the patients to retrieve the required health information in a convenient and time-efficient manner. The

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nurse also helped to document the action plan with concise statements in the goal attainment form, which was 186 kept by the patients as reminder.

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Each session is began with a review of the key messages from and a discussion of the patients' progress in 189 attaining the goals set in the previous session. Symptom monitoring, which enabled patients to detect early signs of 190 fluid overload or inadequate cardiac output, was taught in the first session. This arrangement helped to increase the 191 patients' understanding of the subsequently taught self-care practices, because fluid status and cardiac output serve 192 as important indicators to guide the decision-making process for dietary modifications, diuretic adjustments and 193 activity pacing. The patients will be taught to record their daily symptom status, including body weight, peripheral 194 oedema and shortness of breath, on a self-monitoring form using simple methods (Additional Material 2), and 195 emphasis was placed on teaching the patients to observe and interpret any changes. To help the patients to develop 196 the habit of daily self-monitoring, the nurse reviewed their records for five consecutive weeks during the face-to-197 face sessions and provided them with feedback. As we found that the majority of CHF patients had difficulty in 198 reading a needle-base bath scale in our previous HMRF project, a digital bath scale with an enlarged font display 199 was provided to the intervention group. Because the main purpose of the study was to test the effects of an 200 empowerment-based educational method, subjects in the control group also received the same weight scale. Indeed, 201 the weight scale serves as a meaningful incentive to encourage subjects' participation in the study.

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Telephone follow-up

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The research nurse made three weekly and thereafter two bi-weekly telephone calls to the patients on the 204 completion of the five face-to-face sessions. A telephone follow-up record has been developed to facilitate the 205 process. The record documented the patient's clinical profile, CHF-related treatment (medication, diet and fluid 206 prescription) and self-care goals and corresponding action plan identified in the face-to-face sessions. The nurse read 207 this information before making the telephone call, so that she had clear focus on the monitoring and supporting self-208 care performance of each individual patient. During each telephone call, the nurse clarified any questions and 209 concerns on self-care. Particular focus was placed on monitoring the level of goal attainment, identifying any 210 challenges being encountered by the patients in implementing the action plan, and suggesting methods to resolve 211 any self-care problems. Depending on the patients' progress, the goal and action plan was adjusted when necessary.

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Further health counselling that was relevant to individual patients' self-care needs were provided. After each 213 telephone conversation, the nurse updated the telephone monitoring record by documenting the progress in goal 214 attainment, any unresolved or new problems in self-care performance and the health counselling given. Such 215 information helped to guide the discussions in subsequent telephone follow-ups.

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For the control group: didactic education 217 Subjects in the control group received didactic education, which included a total of five 45-min health 218 education sessions on the same topics as the intervention group. The nurse presented the health information to the 219 patients, but no empowerment strategies, such as the five-step goal setting process, ongoing monitoring and patient-220 centered supportive interventions on goal attainment were offered. Upon completion of the education sessions, the 221 nurse made three telephone calls over 7 weeks to each subject. The purpose of the telephone call will be to act as an attention placebo. The nurse had general discussion on disease management with the patients and reminded them to 223 follow the given health advice.

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The measures listed below were used to measure the outcome variables.
with a higher score representing a better self-care attribute. The SCHFI (Chinese version) is culturally relevant when used in elderly Chinese CHF patients in Hong Kong, with Cronbach's alpha of 0.93. 3) The Self-care Self-Efficacy Scale

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The 10-item SCSES was used to measure the self-care efficacy of HF patients in performing self-care. 23 Each 238 item was rated on a '1-5' Likert Scale and the total score is rescaled to '0-100' range, with higher score 239 indicating higher level of self-confidence.

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The 21-item MLHFQ (Chinese version) 24 will be used to measure the disease-specific HRQL of HF patients.

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The total score can range of 0 to 105, with higher scores indicating poorer HRQL. Cronbach's alpha is reported

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The AED attendance of the subjects after they have been randomized to the study group will be monitored up to 249 a period of 6 months (i.e., from baseline to 3 months upon the completion of the study interventions). The 250 information was traced from the clinical management system of Hospital Authority.

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Hospital admission of the subjects after they have been randomized to the study group was monitored up to a 254 period of 6 months (i.e., from baseline to 3 months upon the completion of the study interventions). The 255 information was traced from the clinical management system of Hospital Authority. Information about the date 256 of admission, the total length of hospital stay and the index diagnosis of admission was retrieved. The research 257 nurse will also ask the subjects for any admission to the private hospital and collect the same information by 258 patients self-report.

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The data was double-entered for validation and analyzed on an intention-to-treat basis. Skewed variables would be 262 appropriately transformed before being subjected to analyses. Baseline characteristics between the two arms of 263 participants was compared using t-test, chi-square or Fisher's exact tests, as appropriate. For the self-care, self-care 264 self-efficacy, heart failure knowledge and HRQL outcomes, generalized estimating equations (GEE) model will be 265 used to compare the differential changes in each of the outcomes (self-care maintenance, self-care management, 266 self-care confidence, self-care knowledge and HRQL) across the time-points T0 (baseline), T1 (post-test) and T2 (3 267 months after post-test) between the two study arms, with adjustment for potential confounding variables in order to 268 obtain a more precise estimation of intervention effect. The potential confounding variables would selected on the 269 basis of statistical incomparability at the baseline with p values < 0.25 for between-group differences 25 . GEE model 270 can account for intra-correlated repeated measures data and accommodate missing data caused by incomplete visits or drop-out, provided the data are missing at random 26 and thus is particularly suitable for intention-to-treat (ITT) analysis without the need to impute missing data. If the data is not missing at random, multiple imputation method 273 would be used to impute missing data, using all available baseline characteristics as covariate. Predictive mean 274 matching approach 27 which relies less on the parametric assumptions of the imputation models would be used. The 275 episodes of accidental emergency department (AED) attendance and hospitalization was compared between the two 276 groups using generalized linear model with the use of appropriate link function. The choice of the link function will 277 be determined on the basis of the distributions of the above hospital utilization outcomes. Furthermore, Cox 278 regression analysis will be performed to compare the time to hospital admission between the two.

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Cost effectiveness analysis was performed on total cost incurred in both the empowerment-based self-care program 280 (intervention) and dialectic education (control) as well as incremental cost-effectiveness ratios expressed as 281 incremental cost per (1) an AED attendance avoided, (2) a day of hospitalization reduced, (3) a minimal clinically 282 important difference (MCID) in SCFHI scores (self-care management, symptom perception, and self-care 283 maintenance which showed significant between-group difference), and (4) a quality-adjusted life year (QALY) 284 gained derived from MLHQ over the period from T0 to T2 (i.e., approximately 6-month time horizon) of the study.

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The component items of the total cost, including intervention, direct medical and societal costs are listed in Table 1.

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All the cost data involved will be expressed in Hong Kong dollars and valued on the starting date of the study from a 287 health-care system perspective (i.e., all the medical costs will be valued on the basis of non-subsidized cost). All 288 intervention, direct medical and societal costs incurred will be estimated per each participants using the method of

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Thompson & Barber 28 and the average cost difference between the intervention and control groups (intervention -290 control) was used to derive the incremental total cost (or total cost saved). Biased-corrected and accelerated 291 bootstrapping method with 10000 replications 29 will be used to estimate a 95% confidence interval (CI) for the 292 incremental total cost (or total cost saved). Mean differences in (1) episode of AED attendance and (2) total length 293 of hospitalization during the period from T0 to T2 (approximately 6 months as well as (3) one MCID SCFHI at T2 294 (6 months) relative to T0 (the baseline) and (4) QALY between the two groups were adopted as the incremental 295 effect measures. The above bootstrapping method was used to estimate 95% confidence intervals for the incremental confidentiality and anonymity, and right to withdraw was emphasized. In particular, the subjects' was informed that 306 they could refuse to participate or withdraw consent at any time without affecting the service they are entitled to 307 receive. The subjects' name will not appear on any data record sheets and will be locked up in a secure location.

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Confidentiality of the subjects' personal data will be protected according to the Personal Data (Privacy) Ordinance.

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They can enjoy this right for the protection of their personal data, such as collection, retention, management, use 310 (including analysis or comparison), non-disclosure, and erasure and/or in any way dealing with or disposing of any 311 of their personal data in or for this study. Written informed consent will be obtained.

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Impact and future direction

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The detrimental consequences of HF not only hamper the quality of life of patients, but also strain already over-314 stretched hospital resources. As ineffective self-care behaviour has been consistently identified as a significant 315 modifiable predictor of hospital admissions, enhancing patients' ability to manage the disease and treatment regimen is regarded as the cornerstone of a successful HF management model. However, the degree to which HF-related selfprogramme proposed in this study is targeted at addressing this research gap. The unique program features to empower the patients to engage in the complex decision making of symptom recognition, interpretation and response as well as self-care maintenance through goal-setting, patient-professional partnership and explicit methods and tools are central to modify their clinical outcomes. If the empowerment-based self-care programme is effective the established materials (e.g. protocol, resource materials, and telephone follow-up records), can readily applied to clinical venues locally and beyond through knowledge translation process. The model of self-care enhancement can 325 also be applied to primary care settings to empower CHF patients to manage the disease in the community. It can 326 also be integrated to rehabilitation or transitional care service to enhance the patients' outcomes. Whereas 327 international practice guideline advocates on self-care enhancement for this clinical cohort, this study can provide 328 important insights to advance the corresponding evidence-based practice.

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 Patients will be asked to explain why they make the selection.

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3. Structured education on the following topics:

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 What is heart failure.

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 Highlight failing of the myocardium pump to maintain adequate metabolic needs and normal 502 venous blood flow.

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 Symptom manifestations of heart failure.

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 Highlights that the symptoms occur as a result of venous congestion and inadequate 505 myocardial blood supply, and thereby explain the importance of symptom recognition.

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 PowerPoint-guided story telling (The story depicts scenes of a HF patients (Sum Kor) accurately 507 integrating symptom monitoring on edema, body weight, fatigue and shortness of breath to 508 everyday life. The story will illustrate the common barriers to implement this self-care and the 509 corresponding coping methods.  6. Facilitate patients to take turn to mention how they incorporate symptom monitoring to daily routine.

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-Encourage patients to brainstorm how to achieve their identified goal. Provide as many options as 518 possible.

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-Encourage patients to discuss their concerns and anticipated barriers.

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-Encourage patients to identify resource (person/ equipment) which could help.

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Suggest resolving method and facilitate peer sharing.   Encourage patients to brainstorm how to achieve their identified goal. Provide as many options as 579 possible.

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 Encourage patients to discuss their concerns and anticipated barriers.

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 Encourage patients to identify resource (person/ equipment) which could help.

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 Suggest resolving method and facilitate peer sharing.

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 Summarize the actions for goal attainment for each patient, and document the action plan on the goal 584 attainment form.

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7. Distribute the resource note on dietary and fluid modification, in which patients can find a pictorial guide on 586 low sodium food and high sodium food, a pictorial guide of low-sodium diet from menus of Chinese restaurant.

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Assist the patients to document the action plan on the goal attainment form.

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Session 3: Medication management  3. Patients are able to identify medication safety tips for medication usage, storage and refill.

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Need to check the current medication record of the patients in the group from the baseline clinical data so as to tailor 599 the education content.

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 Patients take turns to describe the purpose of taking the current medications.

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 Patients take turns to describe the methods they used to prevent medication errors (e.g. skip dose or 614 taking the wrong medications).

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 Patients take turns to describe how they adjust the diuretics according to their symptom status.

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3. Structured education on the following topics using the PowerPoint Slides.

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 The roles of heart failure medications in disease management.

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 The indications, common side effects and safety considerations of the heart failure medications (focused 619 on those which are currently prescribed for the participants in the group)

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 The principles and methods of taking flexible diuretic regimen.

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 Quick tips to enhance medication compliance.

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 Medication safety tips. symptoms on the A4-size card.

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Patients have to explain why they pick the cards and how they response to those bodily 686 changes.

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3. Structured education on the following topics using the PowerPoint Slides.

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 The bodily cues which indicate the deterioration of heart failure.

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 Methods to increase ones' awareness to deteriorated symptoms.

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 Early remedies to reverse the deteriorated symptoms through dietary, activity and diuretic adjustment.

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 Methods to monitor and evaluate the effectiveness of the remedies for deteriorated symptoms.

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 Ways to make decision for seeking medical attention for deteriorated heart failure symptoms.

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 Health consequence for delayed remedy or care seeking for the disease deterioration.

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 PowerPoint-guided story telling (The story depicts scenes of a HF patients (Sum Kor) who recognizes 695 early deteriorated heart failure symptoms and demonstrate appropriate actions to cope with the symptoms.

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The scenario also illustrates how to cope with the common psychosocial barriers which hinder prompt 697 self-care management.

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Facilitate the patients to identify the discrepancies, if any, in how to monitor for and response to 702 deteriorated heart failure symptoms.

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Recall the information in the structured education and highlight the detrimental health consequence 704 of their self-care deficit in managing the symptom deterioration.

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 Support the patients to set their self-care goals on medication management.

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 Document the identified goals on the goal attainment booklet. intolerance.
Upon the completion of the five face-to-face sessions, the intervener has to give three weekly and thereafter two bi-796 weekly telephone calls to the patients. The main purpose of the telephone follow-up is to monitor patients' progress 797 on goal attainment and to support their implementation of the action plans in their home environment. Efforts have 798 to be placed on identifying patients' concerns, questions, and challenges encountered in implementing the self-care,

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and to suggest resolving methods. Further health counseling has to be provided, with emphasis placed on helping 800 patients to translate the knowledge and skills taught in the face-to-face session to their own real life situation.

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Depending on the patients' progress, adjust the self-care goal and action plan accordingly.

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Followings are the activity guide for the intervener before, during and after making the telephone call.

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 Identify their concerns, problems and difficulties encountered by the patient in implementing the action plan.

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Discuss with the patients the possible resource can help to overcome the difficulties.

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 Collaborate with the patients to identify any resolving methods to overcome the challenges. Recall the 818 knowledge and skills taught in the face-to-face session, and provide suggestion on how such knowledge and 819 skills can be applied to their real life situation.

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 Remind the patients to read the relevant resource notes provided in each face-to-face session.

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 Adjust the self-care goal if necessary and refine the action plan. Self-Monitoring Form activity, with '1' represents "no shortness of breath at all " and '5' represents "Shortness of breath as bad as can be".

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Please put a stick to represent your level of shortness of breath for each calendar day.