A comparative analysis on treatments for heart failure patients - Research Proposal Example

? A Comparative Analysis on Treatments Available for Heart Failure Patients Table of Contents Page Page i Table of Contents ii List of Tables iii List of Appendices iv Abstract v Introduction 1 Literature Review 5 Methods of Procedure 9 Findings/Results 11 Discussion/Summary 12 Conclusion 17 References 18 Appendices 22 List of Tables Table Page 1. New York Heart Association Classification of 13 Stages of Heart Failure 2. Costs and Survival at Selected Time Points Over the Modeled 34 Treatment Episode List of Appendices Page A. Sample Questionnaire (for HF Patients) 21 B. Sample Questionnaire (for Physicians/Practitioners) 27 C. Sample Questionnaire (for product manufacturers/distributors) 28 D. Proportion of Interviewed HF Patients Undergoing 30 the Method of Their Choice E. Proportion of Interviewed Doctors and Their Preferred HF Methods 31 F. Costs and Survival at Selected Time Points 34 Over the Modeled Treatment Episode Abstract Heart failure (HF) is included in the group of cardiovascular diseases, which is the leading cause of death not just in the United States but all over the globe. Two of the many options of treating HF are the use of pharmacologic therapy (PT), and another is the use of an implanted cardiac resynchronization device (I-CRD) to regulate the heart’s beating. It was found out that the combination of both PT and I-CRD to treat HF patients was overall the best choice in both cost-effectiveness as well as improving the quality of life of patients, followed by sole use of I-CRD and PT, respectively. Also, among the patients surveyed, patients below 60 years of age prefer OPT more than I-CRT, while older patients have a preference for I-CRT, combined with OPT. For physicians, there is an equal preference for OPT and combination of OPT and I-CRT, but not I-CRT alone due to risks of sudden death. Lastly, although longer lives may be expected from users of implanted devices, the costs are double those of OPT alone, which makes OPT more affordable. keywords: heart failure, HF, implanted cardiac resynchronization device, I-CRT, pharmacologic therapy, PT A Comparative Analysis on Treatments Available for Heart Failure Patients Heart failure is the failure of the heart to pump enough oxygen in the bloodstream as needed by the body for normal functioning (Abraham & Krum, 2007). It is at present one of the most prevalent diseases occurring in the modern age. In the US alone, the rates of patients that seek medical help for treatment of heart failure increased from 1.7 million to 2.9 million annually (Jessup & Loh, 2003). Substantial disturbance of pumping enough oxygenated blood throughout the body can gravely affect the health of a person and may even be the cause of slow death of organs and eventually the body. In order to assess whether or not a patient has heart failure, assessment via echocardiogram (ECG), magnetic resonance imaging (MRI) as well as x-rays may be used, along with the use of certain biochemical tests (Abraham & Krum, 2007). Upon verification of disease, treatment may ensue, depending on the severity of the disease. These can be either or both the use of pacemakers as well as pharmacological agents to treat the symptoms of heart disease in patients (Timperley, Leeson, Mitchell & Betts, 2008). Today there are many pacemakers available for heart failure patients, which can either be temporary or permanent, operates on just one chamber or two chambers of the heart, and can be implanted inside the abdomen or is just placed outside the chest, over the heart (Maisel, 2010). With its invention in the 1950’s, as a device that could help the heart pump out blood as much as what is needed, patients with heart failure were given an increased life span (Timperley et al., 2008). Since its invention, over two million people have reaped the benefits of a technology that is still evolving up to this date. At present, one of the most advanced technologies available for heart failure patients is the implanted cardiac resynchronization device (I-CRT). In a study by van Veldhuisen et al. in 2009, there was a significant decrease of patient mortality receiving such treatments in the European Union, by up to 36%. Along with the use of an implanted cardiodefibrillator, mortality rates were also significantly decreased by 20%. Due to the high costs of implanted medical devices, many patients still resort in using pharmacologic treatment of heart failure, which is mostly the usage of drugs such as digoxin, beta-blockers and ACE that affect the dilation of major blood vessels as well as minimizing or preventing heart arrhythmia in patients with heart failure (Feldman, 2006). Combinations of drugs are usually employed in treating heart failure. This is mainly to alleviate the side-effects of one or more drugs, as well as to prevent fluid retention in the body (Jessup & Loh, 2003). Though the use of drugs and pacemakers may have increased the lifespan of some heart failure patients, it can’t be denied that the costs of treatment as well as maintenance can be high. If the disease is already severe, treatment may only extend the life of patients as well as alleviate the symptoms being experienced, but eventually there would still be deterioration of the patient’s heart in the long term (Jessup & Loh, 2003). Maisel (2010) also mentions that depending on the severity of the patient’s disease, either drugs or I-CRT would work well alone. Depending on the clinical trials being given, it can be expected that in order to see any improvement in the implementation of such treatments, the benefit should outweigh the risk. If the disease is mild, the use of medicine to alleviate the symptoms should suffice. However, with patients that have severe symptoms, the use of pacemakers could only help increase their lifespan substantially (Maisel, 2010). More often than not, the use of drugs alone with patients that have severe chronic heart failure would cause eventual heart failure due to sudden death (Feldman, 2006). Also, there is a decreased novelty in the use of pharmacological methods of treating heart failure patients, mainly due to initial clinical trials that yield positive results in small-scale trials but have a slightly lower positive response when conducted at a large scale (van Veldhuisen et al., 2009). The complicated side-effects in the use of drugs also add up to the bulk of the problem with respect to the well-being of patients (Maisel, 2010) This study aimed to find out whether the sole usage of either pharmacological treatment of heart failure or the usage of a pacemaker, specifically the implantable cardiac resynchronization therapy (I-CRT) would be a better option for heart failure patients. The objectives of the study were the following: 1. To compare and contrast the mechanism of actions of I-CRT and drugs on heart failure patients; 2. To compare the efficiency of the use of pharmacological treatment versus I-CRT in patients with respect to their lifespan and quality of life; and 3. To assess the risk and cost analyses of using either of the two treatments alone or when used in combination with each other. After the completion of the study, the following questions are answered: 1. Is there a preference for either I-CRT or the use of medicines in the treatment of heart failure among patients? 2. Which method of treatment has a higher percentage of use among patients? 3. Which treatment method significantly increases the lifespan as well as the quality of life of afflicted patients? 4. Which method of treatment has lower risks and cost effectiveness when implemented? The scope of the study focused within patients that have a light to medium severity of heart failure, since the effects of therapies would be more apparent to them, and that they could easily compare their quality of life before and after treatment. The research did not include patients under hospice care, inpatient confinement or bedridden, due to sensitivity issues (e.g. possibility of patient undergoing end-of-life care, thus not providing any information regarding the effects of preferred treatment). Also, there is additional information that needs physicians and other healthcare practitioners’ input, so the scope was limited within specialists or those that work with heart patients as well (e.g. cardiologists), in order to provide assessment and other information with much more relevance to the topic at hand. Literature Review Although there are many definitions of “heart failure”, Abraham and Krum (2007) simplified the various definitions as a group of clinical symptoms that may or may solely cause abnormalities in the function of the heart. Substantial disturbance of pumping enough oxygenated blood throughout the body can gravely affect the health of a person and may even be the cause of slow death of organs and eventually the body. It is at present one of the most prevalent diseases occurring in the modern age. In the US alone, the rates of patients that seek medical help for treatment of heart failure increased from 1.7 million to 2.9 million annually (Jessup & Loh, 2003). In order to assess whether or not a patient has heart failure, assessment via echocardiogram (ECG), magnetic resonance imaging (MRI) as well as x-rays may be used, along with the use of certain biochemical tests (Jessup & Loh, 2003). With such abnormalities present, the typical job of the heart to carry oxygenated blood to all parts of the body would be greatly compromised. Recommended treatments available for heart failure at present are drug treatments, controlled diet, additional physical activity (depends on heart failure severity) as well as additional surgeries like repair of the damaged vascular tissues, surgical implantation of circulatory support devices (pacemakers) or the eventual transplant of a new heart (Young & Mills, 2004). Although there are developments in the course of heart failure and other cardiovascular-related diseases, there is still an observed rise in the population of heart failure patients, mainly due to the acquisition of the disease by the younger generations and the increased lifespan of heart failure sufferers (Moser & Riegel, 2001). Feldman (2006) explained how certain drugs could also help HF patients in alleviating their symptoms. Aside from using implanted devices to control the heartbeat of a patient with HF (heart failure), additional drug treatment for suppression of irregular beat may be required. This is to help prolong the functioning of an implanted device in a patient, such as a cardiac resynchronization therapy device. Since the heartbeat is being regulated by drugs, the I-CRT would need not to send pulses to correct the pumping of the heart. Different pharmacologic treatments such as the combined use of enzyme inhibitors, hormonal regulators and diuretics as well as the use of neuroregulators are available for patients, as well as other drugs which function as “bridges” before the patient undergoes either a surgical addition of heart beat regulatory devices like pacemakers or eventual heart transplant (Yu, Hayes & Auricchio, 2008). Morbidity and mortality among HF patients can be prevented or delayed through the use of pharmacologic agents, such as ACE inhibitors and beta-blockers. As long as proper dosages are given, there are no observed negative effects on patients. However, proper assessments on HF patients should first be undertaken, since side effects like water retention in the lungs and excessive bleeding may be observed (American Heart Association, 2009; Cannon & O’Gara, 2007). At present, there is an increased and improved survival of patients with heart failure due to the impact of the advancement of drugs such as neurohormonal blocking agents and devices such as intracardiac defibrillators (ICD) and biventricular pacemakers (CRT). Unfortunately due to the longer lives of patients, more heart failure sufferers are added each year, making heart failure a rising epidemic in many countries (Greenberg, Barnard, Narayan & Teerlink, 2010). To alleviate the side-effects of the different drugs used in treating heart failure, other medicines are prescribed to prevent onset of additional symptoms, like fluid retention or enema in parts of the body (Jessup & Loh, 2003). Implanted devices as well as pharmacologic treatment can be used in combination with each other due to their synergistic reactions, which can help improve the condition of heart failure patients. This includes the reduced possibility of sudden death among patients (Abraham & Baliga, 2010). The use of devices such as I-CRT not only help in bridging a patient towards a heart transplant, but also help in prolonging the life of HF patients, since more often than not are there more donor hearts to serve the number of potential benefactors of such organ transplants, around 6% of HF patients would be able to get a new heart each year (Iaizzo, 2009). The invention of the pacemaker in the 1950’s ushered the development of devices that serve to bridge the gap before getting an operation in the heart, as well as after the operation. These implantable devices may also be used in conjunction with heart failure therapy drugs in order to alleviate symptoms among affected individuals (Timperley, Leeson, Mitchell. & Betts, 2008). Initially the use of devices such as pacemakers was to allow the patient’s body to stabilize while waiting for a heart transplant. Depending on the clinical trials being given, it can be expected that in order to see any improvement in the implementation of such treatments, the benefit should outweigh the risk. If the disease is mild, the use of medicine to alleviate the symptoms should suffice. However, with patients that have severe symptoms, the use of pacemakers could only help increase their lifespan substantially (Maisel, 2010). More often than not, the use of drugs alone with patients that have severe chronic heart failure would cause eventual heart failure due to sudden death (Feldman, 2006). Also, there is a decreased novelty in the use of pharmacological methods of treating heart failure patients, mainly due to initial clinical trials that yield positive results in small-scale trials but have a slightly lower positive response when conducted at a large scale (van Veldhuisen et al., 2009). The complicated side-effects in the use of drugs also add up to the bulk of the problem with respect to the well-being of patients (Maisel, 2010) At present, aside from using drugs, implantable devices such as defibrillators and cardiac resynchronization therapy devices help in alleviating HF symptoms in patients. (Maisel, 2010). Availability of simplified I-CRT and defibrillators became widespread in alleviating the symptoms of HF, but most importantly, it prevents the occurrence of sudden death among HF patients (Wang & Hayes, 2004). Mortality rates, particularly in the European Union due to heart failure were decreased due to the use of implanted cardiac resynchronization devices, as well as combining them with implanted cardiodefibrillators to enhance blood circulation (Van Veldhuisen, Maass, Priori, Stolt, van Gelder, Dickstein & Swedberg, 2009). For this study, it is hypothesized that depending on the age bracket of the patients, there would be an increasing preference for implanted devices such as I-CRT as the patients get older, and younger patients would be preferring OPT since they do not suffer as much as older patients, and are still able to function normally. Methods of Procedure In order to obtain data for the comparison of both I-CRT as well as the use of pharmacological agents in the treatment of heart failure patients, interviews were conducted based on the following patient demographics: Age Sex Severity of the disease (mild, moderate) Treatment methods being used at the time of interview Almost all of the participants that were included in this study were approached while waiting for their scheduled check-ups in hospitals specializing in cardiovascular diseases. This would ensure that they would be able to comply with the need for HF patients. Also, interviews with health practitioners that specifically deal with heart failure patients were done, in order to assess the current trends in the usage of either I-CRT or pharmacological agents in the treatment of heart failure. Lastly, some companies that produce implanted CRT, pharmaceutical companies as well as distributors of products were interviewed regarding their sales in addition to interviews and surveys on medical practitioners and patients in order to estimate the volume of products being sold and used, either on an annual basis or in a specific timeframe (van Veldhuisen et al., 2009). Questionnaires were patterned based on template questionnaires available online (Best Sample Questionnaire, n.d.; Heart Place, 2007.). Four groups or localities were used as sample populations, and for each population the percentage of each patient for each kind of treatment (I-CRT, medical/pharmacological or combination of both) were recorded. Trends for the use of either or both methods are presented via line and bar graphs upon data collection. Findings/Results The study is to be expected to generate results that would show the proportions of the frequency of usage of different HF treatment methods as well as the preferences of physicians in treating them. A total of 520 patients from four sampled populations were interviewed, and their responses were tallied. Of the four sampled populations, although the sample sizes were not the same, there is a recurring trend among the usage of PT and the use of heart implanted devices such as I-CRT. One trend is that the majority of the patients rely solely on PT alone. Another observed trend is that of the patients relying mostly on PT, these were mostly below the age of 60 years. The 64 physicians that were interviewed were only recommending two methods for treatment of HF: either PT or the combined use of implanted devices, such as I-CRT with defibrillator (I-CRD). All of the physicians interviewed mostly have patients from different racial backgrounds, and their choice of therapy depended on the age of the patient and the severity of their HF. On the other hand, none of the distributors were able to generate data for the cost of PT and implanted devices, since they consider most of these confidential, and would also be dependent on the distributor as well as to where these would be sold. Distributors were only able to provide brochures and leaflets of their products, but these are not within the scope of the study, and are therefore not included in this report. Also, participants were not asked regarding the amount spent on their preferred treatment since the study only surveyed them once. Hence previously published findings are added to support arguments for this case. Discussion and Summary Heart failure, as defined by Abraham & Krum (2007) is any abnormalities exhibited by the heart during its function. The most often used scale in assessing whether a patient’s heart failure is mild, moderate or severe is the New York Heart Association’s Classification of Stages of Heart Failure (Heart Failure Society of America, 2002). Table 1, as shown in the proceeding page shows how the physical activity of a patient correlates with the intensity of the disease, as well as when symptoms would arise. In this study, since only mild to moderate HF patients are interviewed, there would be no data generated regarding severely afflicted HF patients since it is outside the scope and limits. In order to correct the abnormalities being exhibited by heart failure patients such as irregular beats of the heart (arrhythmias), ventricular fibrillation (improper synchronization of the contractions of the heart) and tachycardia (fast heart beat), medicines such as neurohormonal inhibitors, digitalis, diuretics and beta-blockers are used to normalize the exchange of sodium and calcium ions in the nerve receptors of the heart, which helps in keeping the contractions of all ventricles synchronized (Caro et al., 2006; Greenberg, et al., 2010). Implanted regulatory devices such as cardiac resynchronization devices may also be combined with implanted cardiac defibrillators also help in the treatment of HF patients, simply by sending timed electric impulses to the ventricles of the heart that would make them contract, or would force them to contract harder than usual. This repeated sending of steady signals to the heart would help prevent sudden death in HF patients, which is usually caused by irregular beating of the heart, and its eventual cessation (Abraham & Baliga, 2010). Table 2. New York Heart Association Classification of Stages of Heart Failure Class Patient Symptoms Class I (Mild) No limitation of physical activity. Ordinary physical activity does not cause undue fatigue, palpitation, or dyspnea (shortness of breath). Class II (Mild) Slight limitation of physical activity. Comfortable at rest, but ordinary physical activity results in fatigue, palpitation, or dyspnea. Class III (Moderate) Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea. Class IV (Severe) Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased. The use of both medicine and cardiac implants at the same time is actually much more recommended than using each on their own, since using drugs to help regulate heartbeat would lessen the burden on synchronization devices, which depend on irregularities detected in the heart (Feldman, 2006). Also, there is a synergistic action between the device and the medicines being used, which could help alleviate the symptoms of heart failure, such as dizziness and fatigue (Abraham & Baliga, 2010). In order to gather data about the quality of life of some patients of HF, four localities were randomly selected and were chosen as source of sample populations for data gathering. Survey sheets were disseminated to patients and practitioners/specialists staying at hospitals which specialize in cardiovascular diseases. After getting around 130 patients and around 15 specialists in each sampled locality, the questionnaires were collected and the results gathered. For the distributors of medicine and implantable devices, only product descriptions and brochures were given, since the total amount of sales and costs were considered confidential. These are not within the scope of the study and thus are not included in the results. After all of the data has been gathered and sorted, it was found out that in all of the four sample populations, roughly 53-67% were solely using medicine to alleviate their HF symptoms, since the use of implanted devices were much more expensive due to additional costs (operations, other ambulatory services, additional drugs). Also, those that do choose to have implanted devices in their bodies most likely initially suffered a mild form of cardiac dysfunction, hence their reliance to additional treatments. These results coincide with several published data about the status of HF patients with mild or moderate disease (Daubert et al., 2009). Among the 24% that use both implanted devices and drugs in alleviating their symptoms, 74% were actually able to do light to moderate exercises, with a minimum of six minutes each activity. Some of the patients reported that they have lesser grave hospital visits as before, as compared to just using medicinal treatment alone. Lastly, those with a mild to moderate HF reported to have a quality of life that although not as robust as before, is still manageable and that they could still move by themselves. The mean age of the interviewees/respondents was 63 years, which is the common age for the detection of heart failure among patients (Roger et al., 2010). Around 56-63% of respondents were from 60-75 years of age, 27% were above 75 years of age, and 10% were younger than 60. Although they could still do some light daily physical activity, they often report dizziness and a bit of chest pain when overdoing it. Among the 64 cardiologists interviewed, 58% of them recommend that their patients get both drug therapy and implanted devices during the early onset of their HF, while the other 42% recommend the sole use of drugs only, unless the HF is already severe. Due to the non-invasive nature of pharmacological treatment, there is lesser onset of infections as compared to having implanted devices, however side-effects can still be observed if there is lack of proper intake of drugs (Zanolla & Zardini, 2003). None of the participating physicians recommended the sole use of implanted devices due to the risks involved, including infections, arrhythmias, and most notably death while having the operation (AHRQ, 2004). Some of the cardiologists also do not recommend implantation devices to patients with severe HF because there is no reported improvement in their quality of life. Instead, they recommend palliative care, which addresses the needs of patients in debilitating conditions. These include relief of pain, offering of support system for the patient, integrates psychological and spiritual aspects of healing, among others (Jaarsma et al., 2009). According to some of the cardiologists interviewed, although the use of pharmacologic therapy alone may be a lot cheaper for HF patients, it would still be a better choice for them to get implanted devices in combination with their drugs. This is because the additional regulatory feature of such devices would prevent the sudden cessation of proper beating of their heart, which is the common cause of sudden death among HF patients (Daubert et al., 2009). With regards to quality of life among patients, the use of implanted devices still outweigh the results by as much as 29% from just using only pharmacologic treatment since the longevity of patients with quality of life is also increased (Caro et al., 2006; Leon-Martin et al., 2007; Yu, et al., 2008). However, despite I-CRT being a more promising cure over OPT alone, with regards to costs in conjunction with additional quality of life among HF patients, the costs of getting implanted devices are on the average double the amount spent on OPT alone (Feldman et al., 2005). Aside from the average cost of implants, which is around $20,000 - $25,000, additional fees such as payments for facilities and professional fees, replacement of batteries and re-hospitalizations also account for the expenses accrued due to the preference of implants, as opposed to OPT. (Yancy & Filardo, 2009). The total expenditures of the US government with regards to cardiovascular diseases and stroke as of 2009 is estimated at $475.3 billion, which includes costs of physicians and other healthcare professionals, hospitals and other facilities, medications, etc. (American Heart Association, 2009). This is roughly 50% more than the amount spent on cancer and benign tumors, which is around $228 billion, which makes heart diseases relatively more expensive than any other disease group (American Heart Association, 2009). Among the patients of 60 and above age group interviewed, most of them were already receiving Medicare, which constitutes around 60% of their source of finance with regards to healthcare, thus adding up to the statistics of cardiovascular disease expenditures. To summarize, among the patients surveyed, patients below 60 years of age prefer OPT more than I-CRT, while older patients have a preference for I-CRT, combined with OPT. For physicians, there is an equal preference for OPT and combination of OPT and I-CRT, but not I-CRT alone due to risks of sudden death. Lastly, although longer lives may be expected from users of implanted devices, the costs are double those of OPT alone, which makes OPT more affordable. Conclusions Heart failure (HF) is in the group of cardiovascular diseases, which is the leading cause of death not just in the United States but all over the globe. Two of the many options of treating HF mentioned in this study are the use of pharmacologic therapy (PT), and another is the use of an implanted cardiac resynchronization device (I-CRD) to regulate the heart’s beating. It was found out that the combination of both PT and I-CRD to treat HF patients was overall the best choice in both cost-effectiveness as well as improving the quality of life of patients, followed by sole use of I-CRD and PT, respectively. Many doctors recommend the use of pharmacologic treatment because aside from its non-invasive nature, it is also easier to purchase. Although many doctors recommend their patients having implanted devices, it should be done at the early onset of the disease, because the effects would not be as noticeable when HF is severe. In conclusion, it is highly recommended that HF patients first study their options first before undergoing any form of treatment, and then going for checkups as well as following specialists’ orders since their choices would define if they would have the quality of life that they paid for. It is recommended that there should be additional sampled populations (populations of heart failure patients), since participants per sampling site are just above 100/site. Also, if possible and applicable, that quality of life of patients living with severe HF also included, since there might be significant differences than can be observed. Lastly, it is recommended that HF patients be observed for a specific period or a certain duration and be surveyed again (e.g. 5-12 months, repeat survey after one year, etc.) so that the same people interviewed could re-evaluate their quality of lives based on their own experiences. References Abraham, W.T. & Baliga, R.R. (2010). Cardiac resynchronization therapy in heart failure. Philadelphia: Lippincott Williams and Wilkins. Abraham, W.T. & Krum, H. (2007). Heart failure: a practical approach to treatment. New York: McGraw-hill Companies Inc. Agency for Health Research and Quality (2004). Cardiac resynchronization therapy for congestive heart failure. Evidence Report/Technology Assessment: Number 106. Retrieved January 26, 2012 from http://www.ahrq.gov/clinic/epcsums/resynsum.htm American Heart Association (2009). Heart disease and stroke statistics – 2009 update. Journal of the American heart association, 119, 1-161. Best sample questionnaire. (n.d.) Retrieved January 21, 2012. from site http://www.bestsamplequestionnaire.com Cannon, C.P. & O’Gara, P.T. (2007). Critical pathways in cardiovascular medicine (2nd ed.). Philadelphia: Lippincott Williams & Wilkins. Caro, J.J., Guo, S., Ward, A., Chalil, S., Malik, F. & Leyva, F. (2006). Modelling the economic and health consequences of cardiac resynchronization therapy in the UK. Current medical research and opinion, 22(6), 1171-1179. Daubert, J.D., Leclercq, C. & Mabo, P. (2009). Cardiac resynchronization therapy in combination with implantable cardioverter-defibrillator. Europace, 11, 87-92. Feldman, A.M. (2006). Heart failure: pharmacologic management. Oxford: Blackwell Publishing. Feldman, A.M., de Lissovoy, G., Bristow, M.R, Saxon, L.A., De Marco, T., Kass, D.A. (2005). Comparison of medical therapy, pacing, and defibrillation in heart failure (COMPANION) trial. Journal of the American College of Cardiology, 46 (12), 2311-2321. Greenberg, B., Barnard, D., Narayan, S. & Teerlink, J. (2010). Management of heart failure. West Sussex: John Wiley & Sons, Ltd. Heart Failure Society of America (2002). Questions about HF: nyha classification - the stages of heart failure. Retrieved February 16, 2012 from http://www.abouthf.org/questions_stages.htm Heart Place (2007). New patient medical questionnaire. Retrieved January 22, 2012 from http://www.medfusion.net/templates/groups/2869/3966/New%20Patient%20Medical%20Questionnaire.pdf Jaarsma, T., Beattie, J.M., Ryder, M., Rutten, F., McDonagh, T., & Mohacsi, P. (2009). Palliative care in heart failure: a position statement from the palliative care workshop of the heart failure association of the European society of cardiology. European journal of heart failure, 11 (5), 433-443. Jessup, M.L. and Loh, E. (2003). Heart failure: a clinician’s guide to ambulatory diagnosis and treatment. New Jersey: Humana Press Inc. Leon-Martin, A.A., Benezet-Penaranda, J.M., Martinez Delgado, C., & Rodriguez-Martin, J.L. (2007). Effectiveness of resynchronization therapy in pharmacological treatment-resistant patients with NYHA class III-IV heart failure. Emergencias, 20, 237-244. Maisel, W.H. (2010). Device therapy in heart failure. New York, NY: Humana Press. Moser, D. K. & Riegel, B. (2001). Improving outcomes in heart failure: an interdisciplinary approach. Gaithersburg, Maryland: Aspen Publishers. Roger, V.L., Go, A.S., Lloyd-Jones, D.M., Brown, T.M. & Carnethon, M.R. (2010). Heart Disease and Stroke Statistics—2011 Update. Circulation – American Heart Association, 123, e18-e209. Timperley, J., Leeson, P., Mitchell, A. & Betts, T. (2008). Cardiac pacemakers and ICD’s. New York: Oxford University Press. Van Veldhuisen, D.J., Maass, A.H., Priori, S.G., Stolt, P., van Gelder, I.C., Dickstein, K. & Swedberg, K. (2009). Implementation of device therapy (cardiac resynchronization therapy and implantable cardioverter defibrillator) for patients with heart failure in Europe: changes from 2004 to 2008. European journal of heart failure, 11, 1143-1151. Wang, P.J. & Hayes, D.L. (2004). Implanted defibrillators and combined ic-resynchronization therapy in patients with heart failure. In Hayes, D.L. (Ed.), Resynchronization and defibrillation for heart failure: a practical approach (pp.177-208). Oxford: Blackwell Publishing. Yancy, C.W. & Filardo, G. (2009). Cardiac Resynchronization Therapy for Heart Failure Has the Time Come? Circulation – American Heart Association,119, 916-918. Young, J.B. & Mills, R.M. (2004). Clinical management of heart failure. Caddo, OK: Professional Communications Inc. Yu, C.M., Hayes, D.L. & Auricchio, A. (2008). Cardiac resynchronization therapy. Oxford: Blackwell Publishing. Zanolla, L. & Zardini, P. (2003). Selection of endpoints for heart failure clinical trials. European journal of heart failure, 5 (6), 717-723. Appendix A. Sample Questionnaire (for HF Patients) Patient Information Name_________________________________________ Date of Birth _______________________________________ Address ______________________________________________ Telephone Number ___________________________________________ Doctor’s name if registered with one _____________________________________ Please answer the following questions as honest as possible. Thank you! Please check any of the following disorders that you HAVE or HAVE HAD, and indicate the year it was first identified. ____ Yes _____No Cardiomegaly (Enlarged Heart) _________ ____ Yes _____No Heart Disease you were born with (congenital) ____ ____ Yes _____No Rheumatic Fever _________________________ ____ Yes _____No No Murmur_________________________________ ____ Yes _____No Abnormal Heart Valve _____________________ ____ Yes _____No Endocarditis (infected heart valve) ____________ ____ Yes _____No Abnormal ECG___________________________ ____ Yes _____No Angina (heart pain) ________________________ ____ Yes _____No Heart Attack _____________________________ ____ Yes _____No Heart Failure / Cardiomyopathy _____________ ____ Yes _____No Coronary Artery Disease ___________________ ____ Yes _____No Arrhythmia / Abnormal Rhythm______________ ____ Yes _____No Previous Cardiac Arrest ____________________ ____ Yes _____No Defibrillated / Shocked ____________________ ____ Yes _____No Pericardial (sac surrounding heart) Disease_____ ____ Yes _____No Marfan’s Syndrome_______________________ ____ Yes _____No Hospitalized for cardiac reasons______________ ____ Yes _____No Other type of heart disease ___________________________ Please list ALL the medications that you are taking at home. Include ALL prescription medications, non-prescription vitamins, herbal remedies and supplements. Name of Medication Dose/Strength How Many/How Often When Example Lasix 40 mg twice a day morning & night 1) ______________ ____________ _______________ ___________ 2) ______________ ____________ _______________ ___________ 3) ______________ ____________ _______________ ___________ 4) ______________ ____________ _______________ ___________ 5) ______________ ____________ _______________ ___________ 6) ______________ ____________ _______________ ___________ 7) ______________ ____________ _______________ ___________ 8) ______________ ____________ _______________ ___________ 9) ______________ ____________ _______________ ___________ 10) ______________ ____________ _______________ ___________ Please check that you have had or have not had any procedures / diagnostic tests. Write the year and the location of the test in the blank indicated. Procedure Year Location ____ Yes _____No Echo (Heart Ultrasound) _______ ___________ ____ Yes _____No Stress Test _______ ___________ ____ Yes _____No Holter/Event Monitor _______ ___________ ____ Yes _____No Carotid Artery Ultrasound _______ ___________ ____ Yes _____No Heart Catheterization _______ ___________ ____ Yes _____No Heart Angioplasty/Stent Placement _______ ___________ ____ Yes _____No Peripheral Artery Angiogram (Non Heart) _______ ___________ ____ Yes _____No Electrophysiology Study _______ ___________ ____ Yes _____No Heart Rhythm Ablation _______ ___________ ____ Yes _____No Pacemaker/ICD(defibrillator) _______ ___________ ____ Yes _____No Cardiac Surgery _______ ___________ Pains/Difficulties Encountered ____ Yes _____No Chest pain ____ Yes _____No Chest pressure ____ Yes _____No Shortness of breath ____ Yes _____No Difficulty breathing while laying flat ____ Yes _____No Awakening with breathing difficulty ____ Yes _____No Swelling in feet/ankles ____ Yes _____No Palpitations ____ Yes _____No Nearly passing out spells ____ Yes _____No Passing out spells Do you exercise? (Please encircle) No/Sedentary Occasional Regular Active Lifestyle Physically Unable to exercise Type: How long? (Mins) How often? (Per wk) Aerobics ___________________ ___________________ Cycling ___________________ ___________________ Dancing ___________________ ___________________ Jogging ___________________ ___________________ Running ___________________ ___________________ Swimming ___________________ ___________________ Team sports ___________________ ___________________ Walking ___________________ ___________________ Weights ___________________ ___________________ Thank you for your participation in our short survey. Rest assured that your contact details will not be disclosed within and after the conduct of our study. Appendix B. Sample Questionnaire (for Physicians/Practitioners) PCP/Practitioner Information Name_________________________________________ Date of Birth _______________________________________ Address ______________________________________________ Telephone Number ___________________________________________ Affiliations (if any) _____________________________________ Please answer the following questions as honest as possible. Thank you! Patient Demography (Please encircle) Male Female Caters both African-American Asian-American European Descent Hispanic-American Other (please specify)____________ 30 and below 31-45 years 46-60 years 61 years and above Preferred Treatment Methods for Patients with Heart Failure (Please check) Medicine (Pharmacologic Treatment) __________________ Implanted devices (Defibrillators, Pacemakers, etc.) ___________ Combination of both Comments to preferred treatment methods (effectiveness, appropriate for age, etc.) _______________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________________ Thank you very much for participating in our survey. Rest assured that your contact details will not be disclosed within and after the conduct of our study. Appendix C. Sample Questionnaire (for product manufacturers/distributors) Name of the vendor:   ______________________________ Phone number:   ______________________________ Email address:            ______________________________ Fax:                  ______________________________ Address:            ________________________________________________________ 1: Please list the products and services being offered by your firm. __________________________________________________________________________ 2. Please list the prices of each of those products and services being offered. Product1: _________________ Price: ___________________ Product2: _________________ Price: ___________________ Service1: _________________ Price: ___________________ Service2: _________________ Price: ___________________ 3. Provide the ownership and management details of your firm _______________________________________________________________ 4. Do you have collaborations and associations with other countries? a)   Yes b)   No 5. If the answer to the above question is ‘yes’, provide the details of those associations Collaboration1: ________________  Description: ____________________ Collaboration2: _________________ Description: _______________________ Collaboration3: _________________ Description: _____________________ 6. Do you have any discounts or pricing options with your clients? a)   Yes b)   No 7. If the answer to the above question is ‘yes’, mention the discount or pricing option available. _________________________________________________ 8. Does the firm follow any human resources policies and code of ethics? a)   Yes b)   No If ‘yes’, please mention ______________________________________________ 9. Do you keep a backup of all the development of products or services? a)   Yes b)   No Q10. Does your firm confirm with all government regulations? a)   Yes b)   No Appendix D Figure 1. Proportion of Interviewed HF Patients Undergoing the Treatment Method of Their Choice Appendix E Figure 2. Proportion of Interviewed Doctors and Their Preferred HF Methods Appendix F Table 2. Costs and Survival at Selected Time Points Over the Modeled Treatment Episode*     Treatment Group Time Point   CRT-d CRT-P OPT Cumulative average treatment cost          2 yrs   $48,262 $36,668 $25,224  3 yrs   $55,095 $42,562 $31,570  5 yrs   $74,023 $52,796 $40,494  7 yrs   $82,236 $59,870 $46,021 Cumulative average years survival          2 yrs   1.74 1.7 1.62  3 yrs   2.46 2.37 2.21  5 yrs   3.62 3.42 3.07  7 yrs   4.51 4.19 3.64 Cumulative quality-adjusted survival          2 yrs   1.32 1.33 1.11  3 yrs   1.86 1.85 1.51  5 yrs   2.75 2.67 2.1  7 yrs   3.42 3.26 2.48 *- As reported by Feldman et al., 2005. Read More