Hypertension in diabetes.
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Adrenergic beta-Antagonists↗
Biomedical subjects
Sandeep Vijan
Publications and source records attributed to Sandeep Vijan.
Case management for patients with poorly controlled diabetes: a randomized trial.
PURPOSE: To evaluate the effects of a collaborative case management intervention for patients with poorly controlled type 2 diabetes on glycemic control, intermediate cardiovascular outcomes, satisfaction with care, and resource utilization. METHODS: We conducted a randomized controlled trial at two Department of Veterans Affairs Medical Centers involving 246 veterans with diabetes and baseline hemoglobin A(1C) (HbA(1C)) levels >or=7.5%. Two nurse practitioner case managers worked with patients and their primary care providers, monitoring and coordinating care for the intervention group for 18 months through the use of telephone contacts, collaborative goal setting, and treatment algorithms. Control patients received educational materials and usual care from their primary care providers. RESULTS: At the conclusion of the study, both case management and control patients remained under poor glycemic control and there was little difference between groups in mean exit HbA(1C) level (9.3% vs. 9.2%; difference = 0.1%; 95% confidence interval: -0.4% to 0.7%; P = 0.65). There was also no evidence that the intervention resulted in improvements in low-density lipoprotein cholesterol level or blood pressure control or greater intensification in medication therapy. However, intervention patients were substantially more satisfied with their diabetes care, with 82% rating their providers as better than average compared with 64% of patients in the control group (P = 0.04). CONCLUSION: An intervention of collaborative case management did not improve key physiologic outcomes for high-risk patients with type 2 diabetes. The type of patients targeted for intervention, organizational factors, and program structure are likely critical determinants of the effectiveness of case management. Health systems must understand the potential limitations before expending substantial resources on case management, as the expected improvements in outcomes and downstream cost savings may not always be realized.
Aged↗
Pharmacologic lipid-lowering therapy in type 2 diabetes mellitus: background paper for the American College of Physicians.
BACKGROUND: Cardiovascular disease is the primary complication and cause of death in patients with type 2 diabetes mellitus. Modification of cardiovascular risk factors may improve patient outcomes. PURPOSE: To evaluate the effectiveness of pharmacologic lipid-lowering therapy on outcomes in type 2 diabetes mellitus. DATA SOURCES: Review of the literature. STUDY SELECTION: Randomized trials evaluating clinical outcomes of lipid-lowering treatment in patients with diabetes. DATA EXTRACTION: Studies were identified by searching the Cochrane Library, MEDLINE, meta-analyses, review articles, and inquiries to experts. The Cochrane Library and MEDLINE searches were done in September 2002. Data were abstracted onto standardized forms by a single reviewer and were confirmed by a second reviewer. DATA SYNTHESIS: Meta-analysis of 6 primary prevention studies showed that lipid-lowering medications reduced risks for cardiovascular outcomes (relative risk, 0.78 [95% CI, 0.67 to 0.89]; absolute risk reduction, 0.03 [CI, 0.01 to 0.04] in 4.3 years of treatment); 1 major cardiovascular event was prevented by treating 34 to 35 patients. Meta-analysis of 8 studies of secondary prevention showed a similar relative risk (0.76 [CI, 0.59 to 0.93]) but more than twice the absolute risk reduction (0.07 [CI, 0.03 to 0.12] in 4.9 years of treatment) and a number needed to treat for benefit of 13 to 14. Most studies compared a lipid-lowering drug with placebo but did not evaluate the effect of reaching specific cholesterol levels. The benefit of lipid lowering with a fixed dose of a statin appeared to be similar regardless of starting cholesterol levels. LIMITATIONS: Target cholesterol levels and the effectiveness of dose titration (or the use of multiple agents) have not been rigorously examined. CONCLUSIONS: In patients with type 2 diabetes, treatment with lipid-lowering agents reduces cardiovascular risk. Most patients, including those whose baseline low-density lipoprotein cholesterol levels are below 2.97 mmol/L (<115 mg/dL), and possibly below 2.59 mmol/L (<100 mg/dL), benefit from statins. Moderate doses of these drugs suffice in most patients with diabetes.
Anticholesteremic Agents↗
Tissue plasminogen activator was cost-effective compared to streptokinase in only selected patients with acute myocardial infarction.
OBJECTIVE: We sought to explore the patient-specific cost-effectiveness in a community-based sample for a therapy for which the average cost-effectiveness in a clinical trial has been well-described. STUDY DESIGN AND SETTING: Based on a validated multivariate model, we generated predictions of the effectiveness and cost-effectiveness of t-PA compared to streptokinase on 921 consecutive patients who received thrombolytic therapy for acute myocardial infarction. RESULTS: The average cost-effectiveness of t-PA was US dollar 40,140 per life-year saved. For the quartile of patients most likely to benefit, the incremental cost-effectiveness of t-PA was US dollar 15,396. However, only 44% of patients who received thrombolytic therapy had an estimated cost-effectiveness ratio below US dollar 50,000 per year of life saved; the ratio was greater than US dollar 100,000 in 37% of treated patients. Patients in the lowest quartile of expected benefit are, overall, more likely to be harmed than to benefit from t-PA. CONCLUSION: Compared to the pattern of thrombolytic agent choice observed, targeting t-PA to the half of patients most likely to benefit could save 247 lives and US dollar 174 million nationally per year.
Aged↗
The impact of diabetes on workforce participation: results from a national household sample.
OBJECTIVE: Diabetes is a highly prevalent condition that results in substantial morbidity and premature mortality. We investigated how diabetes-associated mortality, disability, early retirement, and work absenteeism impacts workforce participation. DATA SOURCE: We used the Health and Retirement Study (HRS), a national household sample of adults aged 51-61 in 1992, as a data source. STUDY DESIGN: We conducted cross-sectional analyses on the baseline HRS data, and longitudinal analyses using data from eight years of follow-up. We used two-part regression models to estimate the adjusted impact of diabetes on workforce participation, and then estimated the economic impact of diabetes-related losses in productivity. PRINCIPAL FINDINGS: Diabetes is a significant predictor of lost productivity. The incremental lost income due to diabetes by 1992 was 60.0 billion US dollars over an average diabetes duration of 9.7 years. From 1992 to 2000, diabetes was responsible for 4.4 billion US dollars in lost income due to early retirement, 0.5 billion US dollars due to increased sick days, 31.7 billion US dollars due to disability, and 22.0 US dollars billion in lost income due to premature mortality, for a total of 58.6 billion dollars in lost productivity, or 7.3 billion US dollars per year. CONCLUSIONS: In the U.S. population of adults born between 1931 and 1941, diabetes is associated with a profound negative impact on economic productivity. By 1992, an estimated 60 billion US dollars in lost productivity was associated with diabetes; additional annual losses averaged 7.3 billion US dollars over the next eight years, totaling about 120 billion US dollars by the year 2000. Given the rising prevalence of diabetes, these costs are likely to increase substantially unless countered by better public health or medical interventions.
Chronic Disease↗
Extent and cost of informal caregiving for older Americans with symptoms of depression.
OBJECTIVE: The purpose of this study was to obtain nationally representative estimates of the additional time and cost associated with informal caregiving for older Americans with depressive symptoms. METHOD: Data from the 1993 Asset and Health Dynamics Among the Oldest Old Study, a nationally representative survey of people age 70 years or older (N=6,649), were used to determine the weekly hours and imputed costs of informal caregiving for elderly people with no depressive symptoms in the last week, one to three depressive symptoms in the last week, and four to eight depressive symptoms in the last week. RESULTS: Forty-four percent of survey respondents reported one to three depressive symptoms, and 18% reported four to eight depressive symptoms. In multivariate regression analyses that adjusted for sociodemographics, caregiver network, and coexisting chronic health conditions, respondents with no depressive symptoms received an average of 2.9 hours per week of informal care, compared with 4.3 hours per week for those with one to three symptoms and 6.0 hours per week for those with four to eight symptoms. Caregiving associated with depressive symptoms in elderly Americans represented a yearly cost of about $9 billion. CONCLUSIONS: Depressive symptoms in elderly persons are independently associated with significantly higher levels of informal caregiving, even after the effects of major coexisting chronic conditions are adjusted. The additional hours of care attributable to depressive symptoms represent a significant time commitment for family members and, therefore, a significant societal economic cost. Further research should evaluate the causal pathways by which depressive symptoms lead to high levels of caregiving and should examine whether successful treatment of depression reduces the need for informal care.
Activities of Daily Living↗
The impact of a celebrity promotional campaign on the use of colon cancer screening: the Katie Couric effect.
BACKGROUND: Public participation in many preventive health programs is suboptimal. While various interventions to increase participation have been studied, the impact of a celebrity spokesperson on cancer screening has not been rigorously examined. The objective of this study was to assess the impact of Katie Couric's March 2000 Today Show colorectal cancer awareness campaign on colonoscopy rates. METHODS: A population-based observational study was conducted using 2 different data sources: (1) The Clinical Outcomes Research Initiative (CORI) database-a voluntary consortium of 400 endoscopists who performed 95 000 colonoscopies from July 1998 to December 2000; and (2) 44 000 adult members of a managed care organization. Using change point analyses and linear regression models, we compared colonoscopy utilization rates before and after Ms Couric's March 2000 television series. RESULTS: The number of colonoscopies performed per CORI physician per month after Ms Couric's campaign increased significantly (15.0 per month before campaign; 18.1 after campaign; P<.001). After adjusting for temporal trends, a significantly higher postcampaign colonoscopy rate was sustained for 9 months. Analysis also demonstrated a trend toward an increase in the percentage of colonoscopies performed on women (43.4% before campaign; 47.4% after campaign; P =.054). Colonoscopy rates also increased significantly in the managed care organization after Ms Couric's campaign (1.3 per 1000 members per month before; 1.8 after; P<.001). CONCLUSIONS: Katie Couric's televised colon cancer awareness campaign was temporally associated with an increase in colonoscopy use in 2 different data sets. These findings suggest that a celebrity spokesperson can have a substantial impact on public participation in preventive care programs.
Chi-Square Distribution↗
Treatment of hypertension in type 2 diabetes mellitus: blood pressure goals, choice of agents, and setting priorities in diabetes care.
BACKGROUND: Hypertension in patients with type 2 diabetes mellitus is a prevalent condition that leads to substantial morbidity and mortality. PURPOSE: To evaluate the goals and optimal agents for treatment of hypertension in type 2 diabetes. DATA SOURCES: Review of the medical literature STUDY SELECTION: Randomized trials that evaluated the pharmacologic treatment of hypertension in patients with diabetes and reported microvascular and macrovascular outcomes. DATA EXTRACTION: Studies were identified by using the Cochrane Library, MEDLINE, meta-analyses, review articles, and expert recommendation. The searches of the Cochrane Library and MEDLINE were performed in May 2000 and updated in April 2002. Data were abstracted to standardized forms by a single reviewer and were confirmed by a second reviewer. DATA SYNTHESIS: Treatment of hypertension in type 2 diabetes provides dramatic benefit. Target diastolic blood pressures of less than 80 mm Hg appear optimal; systolic targets have not been as rigorously evaluated, but targets of 135 mm Hg or less are reasonable. Studies that compare drug classes do not suggest obviously superior agents. However, it is reasonable to conclude that thiazide diuretics, angiotensin-II receptor blockers, and perhaps angiotensin-converting enzyme (ACE) inhibitors may be the preferred first-line agents for treatment of hypertension in diabetes. beta-Blockers and calcium-channel blockers are more effective than placebo, but they may not be as effective as diuretics, angiotensin-II receptor blockers, or ACE inhibitors; however, study results are inconsistent in this regard. CONCLUSIONS: Treatment of hypertension in type 2 diabetes, with blood pressure goals of 135/80 mm Hg, provides dramatic benefits. Thiazide diuretics, angiotensin II receptor blockers, and ACE inhibitors may be the best first-line treatments, although other agents are usually necessary and goals may not be achieved even with three or four agents. Aggressive blood pressure control may be the most important factor in preventing adverse outcomes in patients with type 2 diabetes.
Adrenergic beta-Antagonists↗
Public use of automated external defibrillators.
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Aircraft↗
When do patients and their physicians agree on diabetes treatment goals and strategies, and what difference does it make?
BACKGROUND: For patients with chronic illnesses, it is hypothesized that effective patient-provider collaboration contributes to improved patient self-care by promoting greater agreement on patient-specific treatment goals and strategies. However, this hypothesis has not been tested in actual encounters of patients with their own physicians. OBJECTIVE: To assess the extent to which patients with type 2 diabetes agree with their primary care providers (PCPs) on diabetes treatment goals and strategies, the factors that predict agreement, and whether greater agreement is associated with better patient self-management of diabetes. DESIGN: One hundred twenty-seven pairs of patients and their PCPs in two health systems were surveyed about their top 3 diabetes treatment goals (desired outcomes) and strategies to meet those goals. Using several measures to evaluate agreement, we explored whether patient characteristics, such as education and attitudes toward treatment, and patient-provider interaction styles, such as shared decision making, were associated with greater agreement on treatment goals and strategies. We then examined whether agreement was associated with higher patient assessments of their diabetes care self-efficacy and self-management. RESULTS: Overall, agreement on top treatment goals and strategies was low (all kappa were less than 0.40). In multivariable analyses, however, patients with more education, greater belief in the efficacy of their diabetes treatment, and who shared in treatment decision making with their providers were more likely to agree with their providers on treatment goals or strategies. Similarly, physician reports of having discussed more content areas of diabetes self-care were associated with greater agreement on treatment strategies. In turn, greater agreement on treatment goals and strategies was associated both with higher patient diabetes care self-efficacy and assessments of their diabetes self-management. CONCLUSION: Although patients and their PCPs in general had poor agreement on goals and strategies for managing diabetes, agreement was associated with higher patient self-efficacy and assessments of their diabetes self-management. This supports the hypothesis that enhancing patient-provider agreement on both overall treatment goals and specific strategies to meet these goals may lead to improved patient outcomes.
Adult↗
Cost-effectiveness of automated external defibrillator deployment in selected public locations.
OBJECTIVE: The American Heart Association (AHA) recommends an automated external defibrillator (AED) be considered for a specific location if there is at least a 20% annual probability the device will be used. We sought to evaluate the cost-effectiveness of the AHA recommendation and of AED deployment in selected public locations with known cardiac arrest rates. DESIGN: Markov Decision Model employing a societal perspective. SETTING: Selected public locations in the United States. PATIENTS: A simulated cohort of the American public. INTERVENTION: Strategy 1: individuals experiencing cardiac arrest were treated by emergency medical services equipped with AEDs (EMS-D). Strategy 2: individuals were treated with AEDs deployed as part of a public access defibrillation program. Strategies differed only in the initial availability of an AED and its impact on cardiac arrest survival. RESULTS: Under the base-case assumption that a deployed AED will be used on 1 cardiac arrest every 5 years (20% annual probability of AED use), the cost per quality-adjusted life year (QALY) gained is $30,000 for AED deployment compared with EMS-D care. AED deployment costs less than $50,000 per QALY gained provided that the annual probability of AED use is 12% or greater. Monte Carlo simulation conducted while holding the annual probability of AED use at 20% demonstrated that 87% of the trials had a cost-effectiveness ratio of less than $50,000 per QALY. CONCLUSIONS: AED deployment is likely to be cost-effective across a range of public locations. The current AHA guidelines are overly restrictive. Limited expansion of these programs can be justified on clinical and economic grounds.
Cost-Benefit Analysis↗
An independently derived and validated predictive model for selecting patients with myocardial infarction who are likely to benefit from tissue plasminogen activator compared with streptokinase.
BACKGROUND: In the Global Utilization of Streptokinase and tPA for Occluded coronary arteries (GUSTO) trial, patients with myocardial infarction who were treated with tissue plasminogen activator (tPA) had a 6.3% 30-day mortality, compared with a mortality of 7.3% among those treated with streptokinase, despite a greater risk of intracranial hemorrhage with tPA. However, in part because of its higher cost, tPA has not been adopted universally. METHODS: Using an independently developed model, we predicted the benefits of tPA therapy in the 24,146 patients in the GUSTO trial and compared these predictions with the actual benefits of tPA, after classifying patients by their risks of mortality and intracranial hemorrhage. We also performed a "patient-specific" cost-effectiveness analysis among different strata of expected benefit of tPA. RESULTS: Our model predicted that among patients with myocardial infarction, 61% of the benefit of tPA use in reducing mortality accrued to only 25% of patients; treating half of patients could capture 85% of the benefit. Including the risk of intracranial hemorrhage, our model predicted that treating half the GUSTO patients with tPA and the others with streptokinase would yield similar outcomes as treating all patients with tPA, because the additional risk of intracranial hemorrhage exceeded the expected benefit in some patients. When patients were stratified into quartiles of risk, the observed outcomes in the GUSTO patients corresponded well with these predicted results. The estimated cost-effectiveness of tPA was sensitive to patient characteristics. CONCLUSION: For selected patients, use of tPA yields substantially better outcomes than streptokinase, and use of the less expensive agent is difficult to justify. For many patients, however, tPA is unlikely to provide any additional benefit and, in some patients, it may even cause net harm.
Adult↗
Informal caregiving for diabetes and diabetic complications among elderly americans.
OBJECTIVES: Little is known regarding the amount of time spent by unpaid caregivers providing help to elderly individuals for disabilities associated with diabetes mellitus (DM). We sought to obtain nationally representative estimates of the time, and associated cost, of informal caregiving provided to elderly individuals with diabetes, and to determine the complications of DM that contribute most significantly to the subsequent need for informal care. METHODS: We estimated multivariable regression models using data from the 1993 Asset and Health Dynamics Among the Oldest Old Study, a nationally representative survey of people aged 70 or older (N = 7,443), to determine the weekly hours of informal caregiving and imputed cost of caregiver time for community-dwelling elderly individuals with and without a diagnosis of DM. RESULTS: Those without DM received an average of 6.1 hr per week of informal care, those with DM taking no medications received 10.5 hr, those with DM taking oral medications received 10.1 hr, and those with DM taking insulin received 14.4 hr of care (p <.01). Disabilities related to heart disease, stroke, and visual impairment were important predictors of diabetes-related informal care. The total cost of informal caregiving for elderly individuals with diabetes in the United States was between $3 and $6 billion per year, similar to previous estimates of the annual paid long-term care costs attributable to DM. DISCUSSION: Diabetes imposes a substantial burden on elderly individuals, their families, and society, both through increased rates of disability and the significant time that informal caregivers must spend helping address the associated functional limitations. Future evaluations of the costs of diabetes, and the cost-effectiveness of diabetes interventions, should consider the significant informal caregiving costs associated with the disease.
Aged↗
Aspirin use and counseling about aspirin among patients with diabetes.
OBJECTIVE: Despite being a safe, effective therapy for lowering cardiovascular risk, only 20% of diabetic patients were using aspirin in the early 1990s. This study examines current physician practices and the use of aspirin therapy by individuals with diabetes. RESEARCH DESIGN AND METHODS: A random sample of diabetic patients receiving care in the Department of Veterans Affairs health care system were surveyed during January-March 2000. The association between aspirin counseling, aspirin use, and reported coronary vascular disease (CVD) and classical CVD risk factors were examined using logistic regression. The effect of increasing aspirin use on risk of myocardial infarction (MI) and cardiovascular mortality was demonstrated by simulation. RESULTS: Seventy-one percent of respondents reported being counseled about aspirin use, and 66% were taking daily aspirin. Individuals with known CVD were more likely to be counseled (odds ratio [OR] 4.9, 95% CI 2.9-8.1) and to use aspirin (2.1, 1.2-3.7). The factor most strongly associated with aspirin use was having been counseled about aspirin therapy by a doctor. We estimate that for this population, increasing daily aspirin use to 90% could prevent an additional 11,000 MIs and potentially save >8,000 lives. CONCLUSIONS: Compared with previous reports, a substantial proportion of these diabetic patients have been counseled about and use aspirin. Most clinicians recognize aspirin as an important treatment for patients with preexisting coronary disease. However, since diabetes is now considered a CVD equivalent, it is imperative that clinicians include counseling about aspirin therapy as a care priority for all their diabetic patients, as this simple intervention may prevent many cardiovascular events and deaths.
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The impact of including passive benefits in cost-effectiveness analysis: the case of automated external defibrillators on commercial aircraft.
OBJECTIVE: Traditional cost-utility analysis assumes that all benefits from health-related interventions are captured by the quality-adjusted life-years (QALYs) gained by the few individuals whose outcome is improved by the intervention. However, it is possible that many individuals who do not directly benefit from an intervention receive utility, and therefore QALYs, because of the passive benefit (aka sense of security) provided by the existence of the intervention. The objective of this study was to evaluate the impact that varying quantities of passive benefit have on the cost-effectiveness of airline defibrillator programs. METHODS: A decision analytic model with Markov processes was constructed to evaluate the cost-effectiveness of defibrillator deployment on domestic commercial passenger aircraft over 1 year. Airline passengers were assigned small incremental utility gains (.001-.01) during an estimated 3-hour flight to evaluate the impact of passive benefit on overall cost-effectiveness. RESULTS: In the base case analysis with no allowance for passive benefit, the cost-effectiveness of airline automated external defibrillator deployment was US dollars 34000 per QALY gained. If 1% of all passengers received utility gain of.01, the cost-effectiveness declined to US dollars 30000. Cost-effectiveness was enhanced when the quantity of passive benefit was raised or the percentage of individuals receiving passive benefit increased. CONCLUSIONS: Automated external defibrillator deployment on passenger aircraft is likely to be cost-effective. If a small percentage of airline passengers receive incremental utility gains from passive benefit of automated external defibrillator availability, the impact on overall cost-effectiveness may be substantial. Further research should attempt to clarify the magnitude and percentage of patients who receive passive benefit.
Aircraft↗
Automated external defibrillator deployment in high schools and senior centers.
BACKGROUND: Policymakers with limited funds have been forced to make difficult decisions regarding which sites merit automated external defibrillators (AEDs). Guidelines have recommended that the allocation of AEDs be based largely on the site-specific risk of sudden cardiac death (cardiac arrest), with devices preferentially located at high-risk venues. However, there are limited data on whether such a strategy is being followed. The authors surveyed low-risk (schools) and high-risk (senior centers) venues to assess the availability of AEDs. METHODS: A random sample of 200 high schools was identified; 12 were excluded, resulting in a final sample of 188. Each was contacted to determine the number of students, number of teachers, availability of AEDs, and number of cardiac arrests during the 2001-02 academic year. For comparison, 20 licensed senior centers were surveyed to assess the availability of AEDs. RESULTS: Among 147 schools that responded to the survey, the mean student enrollment was 1,117 and the mean number of teachers was 58. There were three reported cases of cardiac arrest (2 students, 1 teacher), resulting in an annual incidence of cardiac arrest in a school of 2.1% (95% confidence interval [CI] 0.4%-5.7%). Thirty-seven schools (25%; 95% CI 18%-33%) reported having AEDs and 35 (27%) intended to purchase them. In contrast, among 20 senior centers, AEDs were available at two (10%; 95% CI 1%-32%), and the and there were four reported cardiac arrests (annual incidence 20%). CONCLUSION: The availability of AEDs across different sites may not correspond directly to the risk of cardiac arrest at these sites.
Adolescent↗
Implantable or external defibrillators for individuals at increased risk of cardiac arrest: where cost-effectiveness hits fiscal reality.
OBJECTIVES: Implantable cardioverter defibrillators (ICDs) are highly effective at preventing cardiac arrest, but their availability is limited by high cost. Automated external defibrillators (AEDs) are likely to be less effective, but also less expensive. We used decision analysis to evaluate the clinical and economic trade-offs of AEDs, ICDs, and emergency medical services equipped with defibrillators (EMS-D) for reducing cardiac arrest mortality. METHODS: A Markov model was developed to compare the cost-effectiveness of three strategies in adults meeting entry criteria for the MADIT II Trial: strategy 1, individuals experiencing cardiac arrest are treated by EMS-D; strategy 2, individuals experiencing cardiac arrest are treated with an in-home AED; and strategy 3, individuals receive a prophylactic ICD. The model was then used to quantify the aggregate societal benefit of these three strategies under the conditions of a constrained federal budget. RESULTS: Compared with EMS-D, in-home AEDs produced a gain of 0.05 quality-adjusted life-years (QALYs) at an incremental cost of $5225 ($104,500 per QALY), while ICDs produced a gain of 0.90 QALYs at a cost of $114,660 ($127,400 per QALY). For every $1 million spent on defibrillators, 1.7 additional QALYs are produced by purchasing AEDs (9.6 QALYs/$million) instead of ICDs (7.9 QALYs/$million). Results were most sensitive to defibrillator complication rates and effectiveness, defibrillator cost, and adults' risk of cardiac arrest. CONCLUSIONS: Both AEDs and ICDs reduce cardiac arrest mortality, but AEDs are significantly less expensive and less effective. If financial constraints were to lead to rationing of defibrillators, it might be preferable to provide more people with a less effective and less expensive intervention (in-home AEDs) instead of providing fewer people with a more effective and more costly intervention (ICDs).
Adult↗
Reporting clinical trial results to inform providers, payers, and consumers.
Results of randomized clinical trials are the preferred "evidence" for establishing the benefits and safety of medical treatments. We present evidence suggesting that the conventional approach to reporting clinical trials has fundamental flaws that can result in overlooking identifiable subgroups harmed by a treatment while underestimating benefits to others. A risk-stratified approach can dramatically reduce the chances of such errors. Since professional and economic incentives reward advocating treatments for as broad a patient population as possible, we suggest that payers and regulatory bodies might need to act to motivate prompt, routine adoption of risk-stratified assessments of medical treatments' safety and benefits.
Clinical Protocols↗