Stephen G Pauker

• Tufts Medical Center

Introduction: Randomized studies have demonstrated that compared to chemotherapy alone (ChemoTx), combined modality therapy (CMT) improves early event-free survival in HL patients with early stage disease. However, long-term follow up from randomized trials suggests that overall survival (OS) when receiving ChemoTx alone is equivalent or superior t...

Background There are no randomized controlled trials to inform the decision of which cranial radiation therapy (CRT) strategy to apply to pediatric patients with T-cell acute lymphoblastic leukemia (ALL).ProcedureWe performed a decision analysis using a Markov model in which we compared the life expectancy and quality-adjusted life expectancy when...

Background: The threshold model represents an important advance in the field of medical decision-making. It is a linchpin between evidence (which exists on the continuum of credibility) and decision-making (which is a categorical exercise - we decide to act or not act). The threshold concept is closely related to the question of rational decision-...

Introduction. A consensus-based approach to central nervous system (CNS) directed therapy has yet to emerge for pediatric patients with T-lineage acute lymphoblastic leukemia (T-cell ALL). We previously completed a meta-analysis of event-free survival (EFS) among studies using one of four prophylactic or therapeutic cranial radiation (CRT) strategi...

Individual patients’ values and preferences are critical to patient-centered decisions. When dealing with health outcomes on an interval scale, where many intermediate outcomes must be considered, it can be helpful to encourage the patient decision maker to consider what functional form may be specified and parameterized for a given outcome attribu...

Summary of recommendations: The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group (EWG) found insufficient evidence to recommend testing for predictive variants in 28 variants (listed in Table 1) to assess risk for type 2 diabetes in the general population, on the basis of studies in populations of northern Europe...

Summary of recommendations: The Evaluation of Genomic Applications in Practice and Prevention (EGAPP) Working Group (EWG) found that, for patients with metastatic colorectal cancer (mCRC) who are being considered for treatment with cetuximab or panitumumab, there is convincing evidence to recommend clinical use of KRAS mutation analysis to determi...

To provide an update on recent revisions to Evaluation of Genomic Applications in Practice and Prevention (EGAPP) methods designed to improve efficiency, and an assessment of the implications of whole genome sequencing for evidence-based recommendation development. Improvements to the EGAPP approach include automated searches for horizon scanning,...

Dual processing theory of human cognition postulates that reasoning and decision-making can be described as a function of both an intuitive, experiential, affective system (system I) and/or an analytical, deliberative (system II) processing system. To date no formal descriptive model of medical decision-making based on dual processing theory has be...

Table S1. Evaluation of Behavior of Dual Processing Model for Medical Decision-Making (DSM -M). Threshold probability as a function of individual risk perception.

Appendix: Derivation of DSM-M equation.

Although clinical trials often provide "best evidence" comparing the effectiveness of alternative management strategies, such evidence can be limited in duration or in the results reported, causing clinicians and policy analysts to wonder "what if?" Models of the clinical prognosis-often spanning patients' lifetimes (the "long haul")-are perhaps we...

VTE is a serious, but decreasing complication following major orthopedic surgery. This guideline focuses on optimal prophylaxis to reduce postoperative pulmonary embolism and DVT. The methods of this guideline follow those described in Methodology for the Development of Antithrombotic Therapy and Prevention of Thrombosis Guidelines: Antithrombotic...

Objective testing for DVT is crucial because clinical assessment alone is unreliable and the consequences of misdiagnosis are serious. This guideline focuses on the identification of optimal strategies for the diagnosis of DVT in ambulatory adults. The methods of this guideline follow those described in Methodology for the Development of Antithromb...

Clinical research needs to be more useful to patients, clinicians, and other decision makers. To meet this need, more research should focus on patient-centered outcomes, compare viable alternatives, and be responsive to individual patients’ preferences, needs, pathobiology, settings, and values. These features, which make comparative effectiveness...

Summary of recommendations: The Evaluation of Genomic Applications in Practice and Prevention Working Group (EWG) found insufficient evidence to recommend testing for the 9p21 genetic variant or 57 other variants in 28 genes (listed in ) to assess risk for cardiovascular disease (CVD) in the general population, specifically heart disease and strok...

Following the path forged a half century ago by psychologist Ward Edwards1 and economists John von Neumann and Oskar Morgenstern,2 academicians have proffered descriptive observations and prescriptive theories concerning decision making under uncertainty.3,4 Edwards and his intellectual progeny spawned the field of behavioral decision theory, which...

Background Appreciating the need to better translate biomedical research into improved clinical care and health, the NIH Roadmap was initiated in 2003 to focus on this by strengthening NIH’s central role in clinical research and clinical research training. As part of the needed re-engineering, in 2006 NIH began the CTSA program. At this writing (Su...

A Working Group appointed by the Director of the National Heart, Lung, and Blood Institute (NHBLI) has reviewed the current status of mechanical circulatory support systems (MCSS), and has examined the potential need for such devices, their cost, and certain societal and ethical issues related to their use. The media have reported the limited clini...

Thousands of Americans are injured or die each year from adverse drug reactions, many of which are preventable. The burden of harm conveyed by the use of medications is a significant public health problem, and therefore, improving the medication-use process is a priority. Recent and ongoing efforts to improve the medication-use process have focused...

Some hospitals have instituted voluntary electronic error reporting systems (e-ERSs) to gather data on medical errors, adverse events, near misses, or environmental issues in a peer review-protected environment. An e-ERS allows for real-time review, oversight, and intervention and provides insight into hospital processes in need of modification to...

The American College of Physicians recently highlighted the need to provide increased information comparing the effectiveness of health care interventions to ensure the rational and effective practice of medicine. Comparative effectiveness refers to the evaluation of the relative clinical effectiveness, safety, and cost of 2 or more medical service...

This chapter describes the system used by the American College of Chest Physicians to grade recommendations for antithrombotic and thrombolytic therapy as part of the Antithrombotic and Thrombolytic Therapy: American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Clinicians need to know if a recommendation is...

This chapter about antithrombotic therapy for valvular heart disease is part of the American College of Chest Physicians Evidence-Based Clinical Practice Guidelines (8th Edition). Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh risks, burden, and costs. Grade 2 suggests that individual patient values might...

To determine how hypnosis and empathic attention during percutaneous tumor treatments affect pain, anxiety, drug use, and adverse events. For their tumor embolization or radiofrequency ablation, 201 patients were randomized to receive standard care, empathic attention with defined behaviors displayed by an additional provider, or self-hypnotic rela...

To describe the rate and types of events reported in acute care hospitals using an electronic error reporting system (e-ERS). Descriptive study of reported events using the same e-ERS between January 1, 2001 and September 30, 2003. Twenty-six acute care nonfederal hospitals throughout the U.S. that voluntarily implemented a web-based e-ERS for at l...

OBJECTIVE: To describe the rate and types of events reported in acute care hospitals using an electronic error reporting system (e-ERS). DESIGN: Descriptive study of reported events using the same e-ERS between January 1, 2001 and September 30, 2003. SETTING: Twenty-six acute care nonfederal hospitals throughout the U.S. that voluntarily implemente...

Most panels that develop clinical practice guidelines are poorly equipped to address resource allocation or cost issues associated with management options. This risks neglect, arbitrariness, lack of transparency, and methodological flaws in consideration of resource allocation. We provide recommendations for guideline panels to promote greater tran...

Mortality from invasive candidiasis is high. Low culture sensitivity and treatment delay contribute to increased mortality, but nonselective early therapy may result in excess costs and drug resistance. To determine the cost-effectiveness of anti-Candida strategies for high-risk patients in the intensive care unit (ICU). Cost-effectiveness decision...

Primum non nocere. In Epidemics,1 Hippocrates urged all physicians to provide safe and effective care. Of course, that is not always possible because adverse events or bad outcomes sometimes occur. But physicians are driven to minimize the likelihood of harm, especially adverse events that more careful reasoning, better practices, and better system...

Although influence diagrams have used medical examples almost from their inception, that graphical representation of decision problems has disseminated surprisingly slowly in the medical literature and among clinicians performing decision analyses. Clinicians appear to prefer decision trees as their primary modeling metaphor. This perspective exami...

Women with a history of prior venous thromboembolism have an increased risk for recurrence during pregnancy. Although thromboprophylaxis reduces this risk, recent evidence suggests that, in many cases, prophylaxis can be safely withheld because the estimated recurrence risk is very low. The balance of risks and benefits in women with different recu...

This article about the grades of recommendation for antithrombotic and thrombolytic therapy is part of the Seventh American College of Chest Physicians Conference on Antithrombotic and Thrombolytic Therapy: Evidence-Based Guidelines. Clinicians need to know whether a recommendation is strong or weak, and about the methodological quality of the evid...

This chapter about antithrombotic therapy in native and prosthetic valvular heart disease is part of the Seventh ACCP Conference on Antithrombotic and Thrombolytic Therapy: Evidence Based Guidelines. Grade 1 recommendations are strong and indicate that the benefits do, or do not, outweigh risks, burden, and costs. Grade 2 suggests that individual p...

Differences between observational and randomized studies of the effects of menopausal hormone therapy (HT) on coronary heart disease (CHD) have been attributed to the fact that women who choose to use HT tend to be healthier than those who do not. Although this bias should affect all clinical outcomes with modifiable risk factors, estimates for str...

In the United States more than 6 million persons have chronic venous insufficiency and more than 500,000 have venous ulcers. Patients in whom conservative therapies fail may improve after surgical treatment of superficial and perforating venous disease, but the degree of this benefit is uncertain. We performed a systematic review of health outcomes...

To the Editor: Although the goal of the Health Insurance Portability and Accountability Act of 1996 (HIPAA) is to protect patients' privacy and rights, such protections, if either misunderstood or overzealously applied, could impede necessary communication and thereby negatively affect patient care and safety. One of the explicit exemptions to the...

We performed a meta-analysis of randomized trials comparing coronary artery bypass graft surgery (CABG) with percutaneous transluminal coronary angioplasty (PTCA) for the treatment of coronary artery disease, incorporating new trials and examining long-term outcomes. Previous meta-analyses of trials comparing CABG with PTCA have reported short- and...

With the proliferation of clinical data registries and the rising expense of clinical trials, observational data sources are increasingly providing evidence for clinical decision making. These data are viewed as complementary to randomized clinical trials (RCT). While not as rigorous a methodological design, observational studies yield important in...

With the proliferation of clinical data registries and the rising expense of clinical trials, observational data sources are increasingly providing evidence for clinical decision making. These data are viewed as complementary to randomized clinical trials (RCT). While not as rigorous a methodological design, observational studies yield important in...

Clinicians and patients must decide when treatment effects are large enough to more than offset the adverse effects and costs of therapy. Calculation of the number of patients one needs to treat (NNT) in order to prevent one patient from having the target event is one tool to help with this decision. Clinicians should treat patients when the NNT is...

This report contains most of the text of a proposal we submitted in March, 1994 to ARPA in response to BAA 94-13, for the Health Information Infrastructure Program. This report differs from the proposal only in its organization and in omitting budgetary and administrative details. To a large extent, we have retained the language typical of proposal...

This report contains most of the text of a proposal we submitted in March, 1994 to ARPA in response to BAA 94-13, for the Health Information Infrastructure Program. This report differs from the proposal only in its organization and in omitting budgetary and administrative details. To a large extent, we have retained the language typical of proposal...

Clinicians and patients must decide when treatment effects are large enough to more than offset the adverse effects and costs of therapy. Calculation of the number of patients one needs to treat (NNT) in order to prevent one patient from having the target event is one tool to help with this decision. Clinicians should treat patients when the NNT is...

Initial therapy with ribavirin and interferon alpha-2b results in a higher sustained virological response than interferon alone, but this regimen is expensive. We aimed to examine the cost-effectiveness of 24- or 48-wk initial treatment with combination therapy versus interferon alone for patients who have chronic hepatitis C. Data from recent rand...

OBJECTIVE: Initial therapy with ribavirin and interferon -2b results in a higher sustained virological response than interferon alone, but this regimen is expensive. We aimed to examine the cost-effectiveness of 24- or 48-wk initial treatment with combination therapy versus interferon alone for patients who have chronic hepatitis C.

Many patients with chronic hepatitis C who are treated with interferon suffer a relapse after an initial response. About half of these patients have a sustained virological response to retreatment with the combination of ribavirin and interferon alfa-2b. The aim of this study was to estimate the cost effectiveness of retreatment with combination th...

Cytomegalovirus (CMV) immune globulin (CMVIG) has been shown to significantly reduce severe CMV-associated disease complicating orthotopic liver transplant (OLT). We evaluated the economic impact of severe CMV-associated disease and calculated the marginal cost-effectiveness (C/E) of routine prophylaxis with CMVIG after OLT. C/E analysis. Four teac...

Objective: Cytomegalovirus (CMV) immune globulin (CMVIG) has been shown to significantly reduce severe CMV-associated disease complicating orthotopic liver transplant (OLT). We evaluated the economic impact of severe CMV-associated disease and calculated the marginal cost-effectiveness (C/E) of routine prophylaxis with CMVIG after OLT. Design: C...

Stage A 44-year-old, previously healthy man presented with a three-week history of fatigue and temperatures as high as 38.2°C (100.8°F). The man was a medical resident at a municipal hospital. Response Despite the long list of causes of fever and fatigue, I would be most worried about occupationally related illnesses, such as primary human immunode...

Alendronate sodium and raloxifene hydrochloride were recently approved for the prevention of postmenopausal osteoporosis, but data on their clinical efficacy are limited. We compared these drugs with hormone replacement therapy (HRT) to help women and physicians guide postmenopausal treatment decisions. To help physicians understand how they can be...

# How do you choose antibiotic treatment? {#article-title-2} Even the most common problems in antibiotic treatment do not have simple solutions. Choosing one antibiotic drug from among several candidates entails balancing the benefits and the detriments associated with each. In this article we engage the reader in a common scenario—deciding which...

Over the past decade, the management of patients with nonvalvular atrial fibrillation has been the subject of more papers than any clinician has time to digest. In this issue, Catherwood and colleagues extend their previous model to offer a new cost-effectiveness analysis of therapies for nonvalvular fibrillation.

Chronic hepatitis C (CHC) infection affects nearly 4 million people in the United States. Treatment with interferon alfa-2b has been limited by its cost and low likelihood of long-term response. To examine the cost-effectiveness of alternative pretreatment management strategies for patients with CHC. Decision and cost-effectiveness analysis using a...

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The most appropriate treatment(s) for patients with atrial fibrillation remains uncertain. To examine the cost-effectiveness of anti-thrombotic and antiarrhythmic treatment strategies for atrial fibrillation. We performed decision and cost-effectiveness analyses using a Markov state transition model. We gathered data from the English-language liter...

This is the sixth in a series of eight articles analysing the gap between research and practiceSeries editors: Andrew Haines and Anna DonaldEvidence based medicine is more than just reading the results of research and applying those results to patients because patients have particular features that may make them different from the “average” patient...

Medical decision making must address tradeoffs: between uncertainty and the risk of obtaining information, between quality of life and quantity of life, between the short term and the long run, between cost and effectiveness, between the individual and society, and perhaps between physicians and their patients. This journal focuses on making such t...

Chronic hepatitis C is a major cause of illness and death in the United States. Interferon-alpha 2b can induce clinical, biochemical, and virologic remission in some patients with chronic hepatitis C, but the long-term cost-effectiveness of this treatment, particularly in patients with histologically mild disease, is unknown. To estimate the cost-e...

With improvements in HIV antibody test (ELISA) performance, the window of time between infection and seroconversion becomes a major source of error in HIV screening. The authors examined its impact on the false-reassurance rate (FRR). Test sensitivity was modeled as the product of two factors: the inherent sensitivity (sensitivity when antibody is...

In Reply. —Dr Rozenberg and colleagues observed that Belgian gynecologists consider risk factors for osteoporosis, but not for CHD, when prescribing HRT. Similarly, recent surveys of US women found that CHD prevention was rarely cited as the reason for initiating HRT1 and that women with risk factors for CHD were no more likely to receive HRT than...

Lyme disease, which is caused by the tick-transmitted spirochete Borrelia burgdorferi, 1 usually begins with an expanding skin lesion, erythema migrans, accompanied by malaise and fatigue, fever, headache, stiff neck, and myalgias or arthralgias.2,3 Weeks later, some patients have objective neurologic signs, such as meningitis, cranial neuritis, or...

To examine the effect of hormone replacement therapy on life expectancy in postmenopausal women with different risk profiles for heart disease, breast cancer, and hip fracture. Decision analysis using a Markov model. Published regression models were used to link risk factors to disease incidence and to estimate the lifetime risks of developing coro...