Drug and Alcohol Rehabilitation: Twenty-Four-Hour Ambulatory Blood Pressure Monitoring in Hypertension: An Evidence-Based Analysis.
Twenty-four-hour ambulatory blood pressure monitoring in hypertension: an evidence-based analysis.
Filed under: Drug and Alcohol Rehabilitation
Ont Health Technol Assess Ser. 2012; 12(15): 1-65
The objective of this health technology assessment was to determine the clinical effectiveness and cost-effectiveness of 24-hour ambulatory blood pressure monitoring (ABPM) for hypertension. CLINICAL NEED: CONDITION AND TARGET POPULATION Hypertension occurs when either systolic blood pressure, the pressure in the artery when the heart contracts, or diastolic blood pressure, the pressure in the artery when the heart relaxes between beats, are consistently high. Blood pressure (BP) that is consistently more than 140/90 mmHg (systolic/diastolic) is considered high. A lower threshold, greater than 130/80 mmHg (systolic/diastolic), is set for individuals with diabetes or chronic kidney disease. In 2006 and 2007, the age-standardized incidence rate of diagnosed hypertension in Canada was 25.8 per 1,000 (450,000 individuals were newly diagnosed). During the same time period, 22.7% of adult Canadians were living with diagnosed hypertension. A smaller proportion of Canadians are unaware they have hypertension; therefore, the estimated number of Canadians affected by this disease may be higher. Diagnosis and management of hypertension are important, since elevated BP levels are related to the risk of cardiovascular disease, including stroke. In Canada in 2003, the costs to the health care system related to the diagnosis, treatment, and management of hypertension were over $ 2.3 billion (Cdn). TECHNOLOGY: The 24-hour ABPM device consists of a standard inflatable cuff attached to a small computer weighing about 500 grams, which is worn over the shoulder or on a belt. The technology is noninvasive and fully automated. The device takes BP measurements every 15 to 30 minutes over a 24-to 28-hour time period, thus providing extended, continuous BP recordings even during a patient’s normal daily activities. Information on the multiple BP measurements can be downloaded to a computer. The main detection methods used by the device are auscultation and oscillometry. The device avoids some of the pitfalls of conventional office or clinic blood pressure monitoring (CBPM) using a cuff and mercury sphygmomanometer such as observer bias (the phenomenon of measurement error when the observer overemphasizes expected results) and white coat hypertension (the phenomenon of elevated BP when measured in the office or clinic but normal BP when measured outside of the medical setting).Is there a difference in patient outcome and treatment protocol using 24-hour ABPM versus CBPM for uncomplicated hypertension?Is there a difference between the 2 technologies when white coat hypertension is taken into account?What is the cost-effectiveness and budget impact of 24-hour ABPM versus CBPM for uncomplicated hypertension?A literature search was performed on August 4, 2011 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing and Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from January 1, 1997 to August 4, 2011. Abstracts were reviewed by a single reviewer. For those studies meeting the eligibility criteria, full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. Articles with unknown eligibility were reviewed with a second clinical epidemiologist and then a group of epidemiologists until consensus was established. The quality of evidence was assessed as high, moderate, low, or very low according to GRADE methodology.English language articles;published between January 1, 1997 and August 4, 2011;adults aged 18 years of age or older;journal articles reporting on the effectiveness, cost-effectiveness, or safety for the comparison of interest;clearly described study design and methods;health technology assessments, systematic reviews, meta-analyses, or randomized controlled trials.non-English papers;animal or in vitro studies;case reports, case series, or case-case studies;studies comparing different antihypertensive therapies and evaluating their antihypertensive effects using 24-hour ABPM;studies on home or self-monitoring of BP, and studies on automated office BP measurement;studies in high-risk subgroups (e.g. diabetes, pregnancy, kidney disease). OUTCOMES OF INTEREST: PATIENT OUTCOMES: MORTALITY: all cardiovascular events (e.g., myocardial infarction [MI], stroke);non-fatal: all cardiovascular events (e.g., MI, stroke);combined fatal and non-fatal: all cardiovascular events (e.g., MI, stroke);all non-cardiovascular events;control of BP (e.g. systolic and/or diastolic target level). DRUG-RELATED OUTCOMES: percentage of patients who show a reduction in, or stop, drug treatment;percentage of patients who begin multi-drug treatment;drug therapy use (e.g. number, intensity of drug use);drug-related adverse events.The quality of the body of evidence was assessed as high, moderate, low, or very low according to the GRADE Working Group criteria. As stated by the GRADE Working Group, the following definitions of quality were used in grading the quality of the evidence: HighFurther research is very unlikely to change confidence in the estimate of effect.ModerateFurther research is likely to have an important impact on confidence in the estimate of effect and may change the estimate.LowFurther research is very likely to have an important impact on confidence in the estimate of effect and is likely to change the estimate.Very LowAny estimate of effect is very uncertain.SHORT-TERM FOLLOW-UP STUDIES (LENGTH OF FOLLOW-UP OF #ENTITYSTARTX02264; 1 YEAR): Based on very low quality of evidence, there is no difference between technologies for non-fatal cardiovascular events.Based on moderate quality of evidence, ABPM resulted in improved BP control among patients with sustained hypertension compared to CBPM.Based on low quality of evidence, ABPM resulted in hypertensive patients being more likely to stop antihypertensive therapy and less likely to proceed to multi-drug therapy compared to CBPM.Based on low quality of evidence, there is a beneficial effect of ABPM on the intensity of antihypertensive drug use compared to CBPM.Based on moderate quality of evidence, there is no difference between technologies in the number of antihypertensive drugs used.Based on low to very low quality of evidence, there is no difference between technologies in the risk for a drug-related adverse event or noncardiovascular event. LONG-TERM FOLLOW-UP STUDY (MEAN LENGTH OF FOLLOW-UP OF 5 YEARS): Based on moderate quality of evidence, there is a beneficial effect of ABPM on total combined cardiovascular events compared to CBPM.Based on low quality of evidence, there is a lack of a beneficial effect of ABPM on nonfatal cardiovascular events compared to CBPM; however, the lack of a beneficial effect is based on a borderline result.Based on low quality of evidence, there is no beneficial effect of ABPM on fatal cardiovascular events compared to CBPM.Based on low quality of evidence, there is no difference between technologies for the number of patients who began multi-drug therapy.Based on low quality of evidence, there is a beneficial effect of CBPM on control of BP compared to ABPM. This result is in the opposite direction than expected.Based on moderate quality of evidence, there is no difference between technologies in the risk for a drug-related adverse event.
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Cost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease (COPD) Using an Ontario Policy Model.
Filed under: Drug and Alcohol Rehabilitation
Ont Health Technol Assess Ser. 2012; 12(12): 1-61
Chandra K, Blackhouse G, McCurdy B, Bornstein M, Campbell K, Costa V, Franek J, Kaulback K, Levin L, Sehatzadeh S, Sikich N, Thabane M, Goeree R
In July 2010, the Medical Advisory Secretariat (MAS) began work on a Chronic Obstructive Pulmonary Disease (COPD) evidentiary framework, an evidence-based review of the literature surrounding treatment strategies for patients with COPD. This project emerged from a request by the Health System Strategy Division of the Ministry of Health and Long-Term Care that MAS provide them with an evidentiary platform on the effectiveness and cost-effectiveness of COPD interventions.AFTER AN INITIAL REVIEW OF HEALTH TECHNOLOGY ASSESSMENTS AND SYSTEMATIC REVIEWS OF COPD LITERATURE, AND CONSULTATION WITH EXPERTS, MAS IDENTIFIED THE FOLLOWING TOPICS FOR ANALYSIS: vaccinations (influenza and pneumococcal), smoking cessation, multidisciplinary care, pulmonary rehabilitation, long-term oxygen therapy, noninvasive positive pressure ventilation for acute and chronic respiratory failure, hospital-at-home for acute exacerbations of COPD, and telehealth (including telemonitoring and telephone support). Evidence-based analyses were prepared for each of these topics. For each technology, an economic analysis was also completed where appropriate. In addition, a review of the qualitative literature on patient, caregiver, and provider perspectives on living and dying with COPD was conducted, as were reviews of the qualitative literature on each of the technologies included in these analyses.The Chronic Obstructive Pulmonary Disease Mega-Analysis series is made up of the following reports, which can be publicly accessed at the MAS website at: http://www.hqontario.ca/en/mas/mas_ohtas_mn.html.Chronic Obstructive Pulmonary Disease (COPD) Evidentiary FrameworkInfluenza and Pneumococcal Vaccinations for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisSmoking Cessation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisCommunity-Based Multidisciplinary Care for Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisPulmonary Rehabilitation for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisLong-Term Oxygen Therapy for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisNoninvasive Positive Pressure Ventilation for Acute Respiratory Failure Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisNoninvasive Positive Pressure Ventilation for Chronic Respiratory Failure Patients With Stable Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisHospital-at-Home Programs for Patients With Acute Exacerbations of Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisHome Telehealth for Patients With Chronic Obstructive Pulmonary Disease (COPD): An Evidence-Based AnalysisCost-Effectiveness of Interventions for Chronic Obstructive Pulmonary Disease Using an Ontario Policy ModelEXPERIENCES OF LIVING AND DYING WITH COPD: A Systematic Review and Synthesis of the Qualitative Empirical LiteratureFOR MORE INFORMATION ON THE QUALITATIVE REVIEW, PLEASE CONTACT MITA GIACOMINI AT: http://fhs.mcmaster.ca/ceb/faculty_member_giacomini.htm.FOR MORE INFORMATION ON THE ECONOMIC ANALYSIS, PLEASE VISIT THE PATH WEBSITE: http://www.path-hta.ca/About-Us/Contact-Us.aspx.The Toronto Health Economics and Technology Assessment (THETA) collaborative has produced an associated report on patient preference for mechanical ventilation. For more information, please visit the THETA website: http://theta.utoronto.ca/static/contact.Chronic obstructive pulmonary disease (COPD) is characterized by chronic inflammation throughout the airways, parenchyma, and pulmonary vasculature. The inflammation causes repeated cycles of injury and repair in the airway wall- inflammatory cells release a variety of chemicals and lead to cellular damage. The inflammation process also contributes to the loss of elastic recoil pressure in the lung, thereby reducing the driving pressure for expiratory flow through narrowed and poorly supported airways, in which airflow resistance is significantly increased. Expiratory flow limitation is the pathophysiological hallmark of COPD. Exacerbations of COPD contribute considerably to morbidity and mortality, and impose a burden on the health care system. They are a leading cause of emergency room visits and hospitalizations, particularly in the winter. In Canada, the reported average cost for treating a moderate exacerbation is $ 641; for a major exacerbation, the cost is $ 10,086.The objective of this study was to evaluate the cost-effectiveness and budget impact of the following interventions in moderate to very severe COPD, investigated in the Medical Advisory Secretariat Chronic Obstructive Pulmonary Disease Mega-Analysis Series: smoking cessation programs in moderate COPD in an outpatient setting:- intensive counselling (IC) versus usual care (UC)- nicotine replacement therapy (NRT) versus UC- IC + NRT versus placebo- bupropion versus placebomultidisciplinary care (MDC) teams versus UC in moderate to severe COPD in an outpatient settingpulmonary rehabilitation (PR) versus UC following acute exacerbations in moderate to severe COPDlong-term oxygen therapy (LTOT) versus UC in severe hypoxemia in COPD in an outpatient settingventilation:- noninvasive positive pressure ventilation (NPPV) + usual medical care versus usual medical care in acute respiratory failure due to an acute exacerbation in severe COPD in an inpatient setting- weaning with NPPV versus weaning with invasive mechanical ventilation in acute respiratory failure due to an acute exacerbation in very severe COPD in an inpatient settingA cost-utility analysis was conducted using a Markov probabilistic model. The model consists of different health states based on the Global Initiative for Chronic Obstructive Lung Disease COPD severity classification. Patients were assigned different costs and utilities depending on their severity health state during each model cycle. In addition to moving between health states, patients were at risk of acute exacerbations of COPD in each model cycle. During each cycle, patients could have no acute exacerbation, a minor acute exacerbation, or a major exacerbation. For the purposes of the model, a major exacerbation was defined as one that required hospitalization. Patients were assigned different costs and utilities in each model cycle, depending on whether they experienced an exacerbation, and its severity. Starting cohorts reflected the various patient populations from the trials analyzed. Incremental cost-effectiveness ratios (ICERs)-that is, costs per quality-adjusted life-year (QALY)-were estimated for each intervention using clinical parameters and summary estimates of relative risks of (re)hospitalization, as well as mortality and abstinence rates, from the COPD mega-analysis evidence-based analyses. A budget impact analysis was also conducted to project incremental costs already being incurred or resources already in use in Ontario. Using provincial data, medical literature, and expert opinion, health system impacts were calculated for the strategies investigated. All costs are reported in Canadian dollars.All smoking cessation programs were dominant (i.e., less expensive and more effective overall). Assuming a base case cost of $ 1,041 and $ 1,527 per patient for MDC and PR, the ICER was calculated to be $ 14,123 per QALY and $ 17,938 per QALY, respectively. When the costs of MDC and PR were varied in a 1-way sensitivity analysis to reflect variation in resource utilization reported in the literature, the ICER increased to $ 55,322 per QALY and $ 56,270 per QALY, respectively. Assuming a base case cost of $ 2,261 per year per patient for LTOT as reported by data from the Ontario provincial program, the ICER was calculated to be $ 38,993 per QALY. Ventilation strategies were dominant (i.e., cheaper and more effective), as reflected by the clinical evidence of significant in-hospital days avoided in the study group. Ontario currently pays for IC through physician billing (translating to a current burden of $ 8 million) and bupropion through the Ontario Drug Benefit program (translating to a current burden of almost $ 2 million). The burden of NRT was projected to be $ 10 million, with future expenditures of up to $ 1 million in Years 1 to 3 for incident cases. Ontario currently pays for some chronic disease management programs. Based on the most recent Family Health Team data, the costs of MDC programs to manage COPD were estimated at $ 85 million in fiscal year 2010, with projected future expenditures of up to $ 51 million for incident cases, assuming the base case cost of the program. However, this estimate does not accurately reflect the current costs to the province because of lack of report by Family Health Teams, lack of capture of programs outside this model of care by any data set in the province, and because the resource utilization and frequency of visits/follow-up phone calls were based on the findings in the literature rather than the actual Family Health Team COPD management programs in place in Ontario. Therefore, MDC resources being utilized in the province are unknown and difficult to measure. Data on COPD-related hospitalizations were pulled from Ontario administrative data sets and based on consultation with experts. Half of hospitalized patients will access PR resources at least once, and half of these will repeat the therapy, translating to a potential burden of $ 17 million to $ 32 million, depending on the cost of the program. These resources are currently being absorbed, but since utilization is not being captured by any data set in the province, it is difficult to quantify and estimate. Provincial programs may be under-resourced, and patients may not be accessing these services effectively. (ABSTRACT TRUNCATED)
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Internet-based device-assisted remote monitoring of cardiovascular implantable electronic devices: an evidence-based analysis.
Filed under: Drug and Alcohol Rehabilitation
Ont Health Technol Assess Ser. 2012; 12(1): 1-86
Pron G, Ieraci L, Kaulback K,
OBJECTIVE: The objective of this Medical Advisory Secretariat (MAS) report was to conduct a systematic review of the available published evidence on the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted remote monitoring systems (RMSs) for therapeutic cardiac implantable electronic devices (CIEDs) such as pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. The MAS evidence-based review was performed to support public financing decisions. CLINICAL NEED: CONDITION AND TARGET POPULATION Sudden cardiac death (SCD) is a major cause of fatalities in developed countries. In the United States almost half a million people die of SCD annually, resulting in more deaths than stroke, lung cancer, breast cancer, and AIDS combined. In Canada each year more than 40,000 people die from a cardiovascular related cause; approximately half of these deaths are attributable to SCD. Most cases of SCD occur in the general population typically in those without a known history of heart disease. Most SCDs are caused by cardiac arrhythmia, an abnormal heart rhythm caused by malfunctions of the heart’s electrical system. Up to half of patients with significant heart failure (HF) also have advanced conduction abnormalities. Cardiac arrhythmias are managed by a variety of drugs, ablative procedures, and therapeutic CIEDs. The range of CIEDs includes pacemakers (PMs), implantable cardioverter-defibrillators (ICDs), and cardiac resynchronization therapy (CRT) devices. Bradycardia is the main indication for PMs and individuals at high risk for SCD are often treated by ICDs. Heart failure (HF) is also a significant health problem and is the most frequent cause of hospitalization in those over 65 years of age. Patients with moderate to severe HF may also have cardiac arrhythmias, although the cause may be related more to heart pump or haemodynamic failure. The presence of HF, however, increases the risk of SCD five-fold, regardless of aetiology. Patients with HF who remain highly symptomatic despite optimal drug therapy are sometimes also treated with CRT devices. With an increasing prevalence of age-related conditions such as chronic HF and the expanding indications for ICD therapy, the rate of ICD placement has been dramatically increasing. The appropriate indications for ICD placement, as well as the rate of ICD placement, are increasingly an issue. In the United States, after the introduction of expanded coverage of ICDs, a national ICD registry was created in 2005 to track these devices. A recent survey based on this national ICD registry reported that 22.5% (25,145) of patients had received a non-evidence based ICD and that these patients experienced significantly higher in-hospital mortality and post-procedural complications. In addition to the increased ICD device placement and the upfront device costs, there is the need for lifelong follow-up or surveillance, placing a significant burden on patients and device clinics. In 2007, over 1.6 million CIEDs were implanted in Europe and the United States, which translates to over 5.5 million patient encounters per year if the recommended follow-up practices are considered. A safe and effective RMS could potentially improve the efficiency of long-term follow-up of patients and their CIEDs. TECHNOLOGY: In addition to being therapeutic devices, CIEDs have extensive diagnostic abilities. All CIEDs can be interrogated and reprogrammed during an in-clinic visit using an inductive programming wand. Remote monitoring would allow patients to transmit information recorded in their devices from the comfort of their own homes. Currently most ICD devices also have the potential to be remotely monitored. Remote monitoring (RM) can be used to check system integrity, to alert on arrhythmic episodes, and to potentially replace in-clinic follow-ups and manage disease remotely. They do not currently have the capability of being reprogrammed remotely, although this feature is being tested in pilot settings. Every RMS is specifically designed by a manufacturer for their cardiac implant devices. For Internet-based device-assisted RMSs, this customization includes details such as web application, multiplatform sensors, custom algorithms, programming information, and types and methods of alerting patients and/or physicians. The addition of peripherals for monitoring weight and pressure or communicating with patients through the onsite communicators also varies by manufacturer. Internet-based device-assisted RMSs for CIEDs are intended to function as a surveillance system rather than an emergency system. Health care providers therefore need to learn each application, and as more than one application may be used at one site, multiple applications may need to be reviewed for alarms. All RMSs deliver system integrity alerting; however, some systems seem to be better geared to fast arrhythmic alerting, whereas other systems appear to be more intended for remote follow-up or supplemental remote disease management. The different RMSs may therefore have different impacts on workflow organization because of their varying frequency of interrogation and methods of alerts. The integration of these proprietary RM web-based registry systems with hospital-based electronic health record systems has so far not been commonly implemented. Currently there are 2 general types of RMSs: those that transmit device diagnostic information automatically and without patient assistance to secure Internet-based registry systems, and those that require patient assistance to transmit information. Both systems employ the use of preprogrammed alerts that are either transmitted automatically or at regular scheduled intervals to patients and/or physicians. The current web applications, programming, and registry systems differ greatly between the manufacturers of transmitting cardiac devices. In Canada there are currently 4 manufacturers-Medtronic Inc., Biotronik, Boston Scientific Corp., and St Jude Medical Inc.-which have regulatory approval for remote transmitting CIEDs. Remote monitoring systems are proprietary to the manufacturer of the implant device. An RMS for one device will not work with another device, and the RMS may not work with all versions of the manufacturer’s devices. All Internet-based device-assisted RMSs have common components. The implanted device is equipped with a micro-antenna that communicates with a small external device (at bedside or wearable) commonly known as the transmitter. Transmitters are able to interrogate programmed parameters and diagnostic data stored in the patients’ implant device. The information transfer to the communicator can occur at preset time intervals with the participation of the patient (waving a wand over the device) or it can be sent automatically (wirelessly) without their participation. The encrypted data are then uploaded to an Internet-based database on a secure central server. The data processing facilities at the central database, depending on the clinical urgency, can trigger an alert for the physician(s) that can be sent via email, fax, text message, or phone. The details are also posted on the secure website for viewing by the physician (or their delegate) at their convenience. RESEARCH QUESTIONS: The research directions and specific research questions for this evidence review were as follows: To identify the Internet-based device-assisted RMSs available for follow-up of patients with therapeutic CIEDs such as PMs, ICDs, and CRT devices.To identify the potential risks, operational issues, or organizational issues related to Internet-based device-assisted RM for CIEDs.To evaluate the safety, acceptability, and effectiveness of Internet-based device-assisted RMSs for CIEDs such as PMs, ICDs, and CRT devices.To evaluate the safety, effectiveness, and cost-effectiveness of Internet-based device-assisted RMSs for CIEDs compared to usual outpatient in-office monitoring strategies.To evaluate the resource implications or budget impact of RMSs for CIEDs in Ontario, Canada. RESEARCH METHODS: LITERATURE SEARCH: The review included a systematic review of published scientific literature and consultations with experts and manufacturers of all 4 approved RMSs for CIEDs in Canada. Information on CIED cardiac implant clinics was also obtained from Provincial Programs, a division within the Ministry of Health and Long-Term Care with a mandate for cardiac implant specialty care. Various administrative databases and registries were used to outline the current clinical follow-up burden of CIEDs in Ontario. The provincial population-based ICD database developed and maintained by the Institute for Clinical Evaluative Sciences (ICES) was used to review the current follow-up practices with Ontario patients implanted with ICD devices. SEARCH STRATEGY: A literature search was performed on September 21, 2010 using OVID MEDLINE, MEDLINE In-Process and Other Non-Indexed Citations, EMBASE, the Cumulative Index to Nursing & Allied Health Literature (CINAHL), the Cochrane Library, and the International Agency for Health Technology Assessment (INAHTA) for studies published from 1950 to September 2010. Search alerts were generated and reviewed for additional relevant literature until December 31, 2010. Abstracts were reviewed by a single reviewer and, for those studies meeting the eligibility criteria full-text articles were obtained. Reference lists were also examined for any additional relevant studies not identified through the search. (ABSTRACT TRUNCATED)
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