Clinical Epidemiology Research Center

West Haven, CT, United States

Clinical Epidemiology Research Center

West Haven, CT, United States
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Falzer P.R.,Clinical Epidemiology Research Center
Acta Psychiatrica Scandinavica | Year: 2012

Objective: Recognizing and incorporating the patient's own perspective into treatment recommendations are essential to optimizing clozapine use. The study describes how the patient's perspective influences clinicians' decision strategies and affects their clozapine recommendations. Method: Psychiatric trainees examined six case vignettes of varying complexity that included clinical and patient perspective information. They made treatment recommendations guided by a well-known switching guideline and rated the factors that influenced their recommendations. Results: The decision to follow the guideline's switch recommendation was influenced principally by the importance of the patient's positive symptom profile. The decision to recommend clozapine in lieu of another treatment was influenced principally by the importance of patient's perspective and patient-specific clinical information. These factors had a significant combined influence on the clozapine recommendation rate: When clinical factors were moderately important, the rate was 8%. When clinical factors were extremely important, the rate was 22% when the patient's perspective was moderately important, but 80% when the patient's perspective was very or extremely important. Conclusion: A clozapine optimization strategy requires skill in advanced decision making, and specifically in prioritizing the patient's perspective without diminishing the importance of clinical information. This skill can be developed through practice-based learning. © 2012 John Wiley & Sons A/S.

Sudore R.L.,University of California at San Francisco | Fried T.R.,Clinical Epidemiology Research Center
Annals of Internal Medicine | Year: 2010

The traditional objective of advance care planning has been to have patients make treatment decisions in advance so that clinicians can attempt to provide care consistent with their goals. The authors contend that the objective for advance care planning ought to be the preparation of patients and surrogates to participate with clinicians in making the best possible in-the-moment medical decisions. They provide practical steps for clinicians to help patients and surrogate decision makers achieve this objective in the outpatient setting. Preparation for in-the-moment decision making shifts the focus from having patients make premature decisions based on incomplete information to preparing them and their surrogates for the types of decisions and conflicts they may encounter when they do have to make in-the-moment decisions. Advance directives, although important, are just one piece of information to be used at the time of decision making.

Fried T.R.,Yale University | Fried T.R.,Clinical Epidemiology Research Center | Vaz Fragoso C.A.,Yale University | Vaz Fragoso C.A.,Clinical Epidemiology Research Center | Rabow M.W.,University of California at San Francisco
JAMA - Journal of the American Medical Association | Year: 2012

Chronic obstructive pulmonary disease (COPD), acommon disease in elderly patients, is characterized by high symptom burden, health care utilization, mortality, and unmet needs of patients and caregivers. Respiratory failure and dyspnea maybe exacerbated by heart failure, pulmonary embolism, and anxiety; by medication effects; and by other conditions, including deconditioning and malnutrition. Randomized controlled trials, which provide the strongest evidence for guideline recommendations, may underestimate the risk of adverse effects of interventions for older patients with COPD. The focus of guidelines on disease-modifying therapies may not address the full spectrum of patient and caregiver needs, particularly the high rates of bothersome symptoms, risk of functional and cognitive decline, and need for end-of-life care planning. Meeting the many need so folder patients with COPD and their families requires that clinicians supplement guideline-recommended care with treatment decision making that takes into account older persons' comorbid conditions, recognizes the trade-offs engendered by the increased risk of adverse events, focuses onsymptomrelief and function, and prepares patients and their loved ones for further declines in the patient's health and their end-of-life care. A case of COPD in an 81-year-old man hospitalized with severe dyspnea and respiratory failure highlights both the challenges in managing COPD in the elderly and the limitations in applying guidelines to geriatric patients. ©2012 American Medical Association. All rights reserved.

Fraenkel L.,Yale University | Fried T.R.,Clinical Epidemiology Research Center
Archives of Internal Medicine | Year: 2010

The need is urgent to provide older persons with individualized information about the benefits and harms of different diagnostic and treatment strategies. This need results from the growing recognition of the heterogeneity in outcomes in older persons with differing comorbidity profiles. The heterogeneity of benefits and harms resulting from treatment is not yet as well appreciated. Warfarin vs aspirin therapy for the reduction of stroke risk in nonvalvular atrial fibrillation provides an example of a treatment for which the benefit-to-harm ratio may actually reverse according to an older person's comorbidities, thus highlighting the importance of basing this treatment decision on individualized outcome data. Despite the wealth of studies in nonvalvular atrial fibrillation, many assumptions are necessary to calculate patient-specific outcomes, and these assumptions may lead to substantial overestimation or underestimation of benefits and harms. Improving care for patients with comorbidities will require substantive increases in the efforts and resources allocated to the collection and dissemination of outcome data for patients with varying comorbidities. ©2010 American Medical Association. All rights reserved.

Coca S.G.,Yale University | Coca S.G.,Clinical Epidemiology Research Center
Current Opinion in Nephrology and Hypertension | Year: 2010

PURPOSE OF REVIEW: The goal of this review is to summarize the recent plethora of data that relate to long-term outcomes after acute kidney injury (AKI). RECENT FINDINGS: Surviving patients with AKI are still at high risk for long-term adverse outcomes, even if serum creatinine returns to normal. After adjusting for potential confounders, many recent studies have demonstrated that AKI is independently associated with chronic kidney disease, end-stage renal disease, and premature death. Unfortunately, definitive evidence from randomized controlled trials demonstrating that prevention or treatment of AKI prevents long-term adverse outcomes is not yet available. SUMMARY: AKI is clearly a prognostic marker for poor long-term outcomes, but more studies will be needed to determine whether AKI is truly causal and whether or not the risk is modifiable. © 2010 Wolters Kluwer Health | Lippincott Williams & Wilkins.

Koyner J.L.,University of Chicago | Parikh C.R.,Yale University | Parikh C.R.,Clinical Epidemiology Research Center
Clinical Journal of the American Society of Nephrology | Year: 2013

AKI is a common and serious complication that is associated with several adverse outcomes in hospitalized patients. The past several years have seen a large number of multicenter investigations of biomarkers of AKI in the setting of cardiac surgery and critical illness. This review summarizes these biomarker results to identify applications for clinical use. The Translational Research Investigating Biomarker Endpoints in AKI (TRIBE-AKI) study showed that blood and urine biomarkers measured preoperatively, immediately postoperatively, and at the time of the clinical increase in serum creatinine in the setting of cardiac surgery all had the ability to improve patient risk stratification for a variety of important clinical end points. Analyses of biomarkers concentrations from the Acute Respiratory Distress Syndrome Network, EARLY ARF, and other studies of critically ill subjects have similarly shown that biomarkers measured early in the clinical course can forecast the development of AKI and need for renal replacement therapy as well as inpatient mortality. Although biomarkers have informed the diagnosis, prognosis, and treatment of AKI and are inching closer to clinical application, large multicenter interventional clinical trials to prevent AKI using biomarkers should continue to be an active area of clinical investigation. © 2013 by the American Society of Nephrology.

Belcher J.M.,Yale University | Belcher J.M.,Clinical Epidemiology Research Center
Advances in Chronic Kidney Disease | Year: 2015

Acute kidney injury (AKI) is a common complication in patients with advanced cirrhosis and is associated with significant mortality. The most common etiologies of AKI in this setting are prerenal azotemia, acute tubular necrosis, and hepatorenal syndrome. Despite the overall poor outcomes of patients with cirrhosis and AKI, potentially efficacious therapies exist but must be tailored to the specific AKI etiology. Unfortunately, determining the etiology of AKI in the setting of cirrhosis is notoriously difficult. Many of the standard diagnostic tools, such as urine microscopy and the fractional excretion of sodium, have traditionally been ineffective. Novel biomarkers of kidney tubular injury may be able to assist with differential diagnosis and the appropriate targeting of treatments by distinguishing structural from functional causes of AKI. In recent studies, both urinary neutrophil gelatinase-associated lipocalin and interleukin-18 have shown the ability to distinguish hepatorenal syndrome from prerenal azotemia and acute tubular necrosis. In addition, multiple biomarkers, including neutrophil gelatinase-associated lipocalin and interleukin-18, have demonstrated the ability to independently predict both progression of AKI and mortality. Critically, recent research also indicated that commonly available tests, fractional excretion of sodium and proteinuria, may also be able to distinguish etiologies of AKI in cirrhosis, but diagnostic cutoffs must be re-conceptualized specifically to this unique AKI setting. © 2015.

Falzer P.R.,Clinical Epidemiology Research Center
Behavioral Sciences and the Law | Year: 2013

Structured professional judgment (SPJ) has received considerable attention as an alternative to unstructured clinical judgment and actuarial assessment, and as a means of resolving their ongoing conflict. However, predictive validity studies have typically relied on receiver operating characteristic (ROC) analysis, the same technique commonly used to validate actuarial assessment tools. This paper presents SPJ as distinct from both unstructured clinical judgment and actuarial assessment. A key distinguishing feature of SPJ is the contribution of modifiable factors, either dynamic or protective, to summary risk ratings. With modifiable factors, the summary rating scheme serves as a prognostic model rather than a classification procedure. However, prognostic models require more extensive and thorough predictive validity testing than can be provided by ROC analysis. It is proposed that validation should include calibration and reclassification techniques, as well as additional measures of discrimination. Several techniques and measures are described and illustrated. The paper concludes by tracing the limitations of ROC analysis to its philosophical foundation and its origin as a statistical theory of decision-making. This foundation inhibits the performance of crucial tasks, such as determining the sufficiency of a risk assessment and examining the evidentiary value of statistical findings. The paper closes by noting a current effort to establish a viable and complementary relationship between SPJ and decision-making theory. © 2013 John Wiley & Sons, Ltd.

Garlo K.,Rush University | O'Leary J.R.,Yale University | Van Ness P.H.,Yale University | Fried T.R.,Yale University | Fried T.R.,Clinical Epidemiology Research Center
Journal of the American Geriatrics Society | Year: 2010

Objectives: To examine caregiver burden over time in caregivers of patients with advanced chronic disease. Design: Observational cohort with interviews over 12 months. Setting: Community. Participants: Caregivers of 179 community-living persons aged 60 and older with advanced cancer, heart failure (HF), or chronic obstructive pulmonary disease (COPD). Measurements: Caregiver burden was assessed using a short-form of the Zarit Burden Inventory to measure psychosocial distress. Results: At baseline, the median caregiver burden was 5 (interquartile range (IQR) 1-11), which indicates that the caregiver endorsed having at least two of 10 distressing concerns at least some of the time. Only 10% reported no burden. Although scores increased modestly over time, the association between time and burden was not significant in longitudinal multivariable analysis. High burden was associated with caregiver need for more help with daily tasks (odds ratio (OR)=23.13, 95% confidence interval (CI)=5.94-90.06) and desire for greater communication with the patient (OR=2.53, 95% CI=1.16-5.53). The longitudinal multivariable analysis did not yield evidence of associations between burden and patient sociodemographic or health characteristics. Conclusion: Caregiver burden was common in caregivers of patients with cancer, HF, and COPD. High burden was associated with the caregiver's report of need for greater help with daily tasks but not with objective measures of the patient's need for assistance, such as symptoms or functional status, suggesting that burden may be a measure of the caregiver's ability to adapt to the caregiving role. © 2010, The American Geriatrics Society.

Coca S.G.,Yale University | Coca S.G.,Clinical Epidemiology Research Center | Singanamala S.,Yale University | Parikh C.R.,Yale University | Parikh C.R.,Clinical Epidemiology Research Center
Kidney International | Year: 2012

Acute kidney injury may increase the risk for chronic kidney disease and end-stage renal disease. In an attempt to summarize the literature and provide more compelling evidence, we conducted a systematic review comparing the risk for CKD, ESRD, and death in patients with and without AKI. From electronic databases, web search engines, and bibliographies, 13 cohort studies were selected, evaluating long-term renal outcomes and non-renal outcomes in patients with AKI. The pooled incidence of CKD and ESRD were 25.8 per 100 person-years and 8.6 per 100 person-years, respectively. Patients with AKI had higher risks for developing CKD (pooled adjusted hazard ratio 8.8, 95% CI 3.1-25.5), ESRD (pooled adjusted HR 3.1, 95% CI 1.9-5.0), and mortality (pooled adjusted HR 2.0, 95% CI 1.3-3.1) compared with patients without AKI. The relationship between AKI and CKD or ESRD was graded on the basis of the severity of AKI, and the effect size was dampened by decreased baseline glomerular filtration rate. Data were limited, but AKI was also independently associated with the risk for cardiovascular disease and congestive heart failure, but not with hospitalization for stroke or all-cause hospitalizations. Meta-regression did not identify any study-level factors that were associated with the risk for CKD or ESRD. Our review identifies AKI as an independent risk factor for CKD, ESRD, death, and other important non-renal outcomes. © 2012 International Society of Nephrology.

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