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Tuesday, November 12, 2013

Engineering the fitness of older patients for chemotherapy: An exploration of Comprehensive Geriatric Assessment in practice

Impact Factor:1.137 | Ranking:21/36 in Social Sciences, Biomedical | 81/136 in Public, Environmental & Occupational Health | 5-Year Impact Factor:1.396Source:2012 Journal Citation Reports® (Thomson Reuters, 2013)
Alexandra L McCarthy al.mccarthy{at}qut.edu.au

Institute of Health and Biomedical Innovation, Queensland University of Technology; Division of Cancer Services, Princess Alexandra Hospital, Australia Peta S Cook

University of Tasmania, AustraliaPatsy Yates

Institute of Health and Biomedical Innovation, Queensland University of Technology; Division of Cancer Services, Princess Alexandra Hospital, Australia Clinicians often report that currently available methods to assess older patients, including standard clinical consultations, do not elicit the information necessary to make an appropriate cancer treatment recommendation for older cancer patients. An increasingly popular way of assessing the potential of older patients to cope with chemotherapy is a Comprehensive Geriatric Assessment. What constitutes Comprehensive Geriatric Assessment, however, is open to interpretation and varies from one setting to another. Furthermore, Comprehensive Geriatric Assessment’s usefulness as a predictor of fitness for chemotherapy and as a determinant of actual treatment is not well understood. In this article, we analyse how Comprehensive Geriatric Assessment was developed for use in a large cancer service in an Australian capital city. Drawing upon Actor–Network Theory, our findings reveal how, during its development, Comprehensive Geriatric Assessment was made both a tool and a science. Furthermore, we briefly explore the tensions that we experienced as scholars who analyse medico-scientific practices and as practitioner–designers charged with improving the very tools we critique. Our study contributes towards geriatric oncology by scrutinising the medicalisation of ageing, unravelling the practices of standardisation and illuminating the multiplicity of ‘fitness for chemotherapy’.

View the original article here

Friday, June 21, 2013

Post-PCI Risk Mixed in Obese Patients (CME/CE)

By Charles Bankhead, Staff Writer, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse PlannerObesity had a mixed effect on outcomes after PCI, conferring an increased mortality risk only after adjustment for potential confounders.Note that obese patients had a higher mortality despite a lower-risk profile that included younger age and less extensive coronary disease.

Obesity had a mixed effect on outcomes after percutaneous coronary intervention (PCI), conferring an increased mortality risk only after adjustment for potential confounders, analysis of a large PCI database showed.

By multivariable analysis, extremely obese patients (body mass index =40 kg/m2) had a 14% higher mortality after PCI compared with normal-weight individuals, including a 22% increase in the mortality hazard among patients with ST segment-elevation myocardial infarction (STEMI), reported Ramesh Daggubati, MD, of East Carolina University in Greenville, N.C, and colleagues.

Obese patients had a higher mortality despite a lower-risk profile that included younger age and less extensive coronary disease, they wrote online in the Journal of the American College of Cardiology.

Before adjustment, post-PCI mortality was slightly lower in extremely obese patients, who also had significantly fewer bleeding complications, the authors stated.

"Unmeasured factors, such as pulmonary embolism and difficulties with airway management may explain the increased risk of in-hospital mortality associated with STEMI in these patients," the authors said of their findings. "Moreover, it is plausible that difficulties with obtaining venous or arterial access in extremely obese patients may be associated with increased complications; however, there are little data to support it."

Another study published simultaneously in JACC showed that the prevalence of obesity in patients undergoing PCI almost doubled from 1998 to 2009. In contrast to the findings reported by Daggubati's groups, the study showed that obesity was associated with significantly higher rates of vascular complications, contrast-induced nephropathy, and nephropathy requiring dialysis, as well as higher mortality.

"A large body of data suggests that obesity is a growing epidemic in the general population, and our study suggests that this has been accompanied by an increase in the obesity profile of the patients undergoing PCI," Hitinder Gurm, MD, of the University of Michigan in Ann Arbor, and colleagues concluded. "There has been a steady increase in the proportion of patients who are submorbidly and morbidly obese, with the submorbidly obese population making up the largest cohort of patients in recent years."

Extreme Obesity and In-Hospital Mortality

Currently 2% of American adults are extremely obese (BMI =40 kg/m2), and the prevalence of extreme obesity quadrupled from 1986 to 2000. Extreme obesity is associated with increased operative and 30-day mortality after coronary artery bypass grafting, but little information has accumulated regarding outcomes after PCI in extremely obese patients.

Several studies have yielded evidence of an obesity paradox, whereby obese patients tend to have better outcomes after PCI, which different investigators have attributed to more intensive medical therapy, early referral, and a reduced risk of vascular complications and bleeding resulting from use of radial access and vascular-closure devices.

Daggubati and colleagues hypothesized that extreme obesity would be associated with increased post-PCI morbidity and mortality. To test the hypothesis, they evaluated data from the American College of Cardiology's CathPCI Registry.

The investigators identified adults who had undergone PCI via femoral or radial access and were discharged from July 1, 2009 to June 30, 2011. They limited the search to patients who had a BMI =40 kg/m2 or who had a BMI of 20 to 25 kg/m2 (normal weight). Outcomes of interest included in-hospital death, bleeding, and intra- and post-procedural adverse events. Bleeding was defined as having occurred within 72 hours of PCI.

The analysis consisted of 83,861 extremely obese patients and 217,616 normal-weight patients. The obese patients had a median age of 60 versus 69 for normal-weight patients (P<0.0001) and were more likely to be female (47% versus 37% of normal-weight patients, P<0.0001) and African American (12% versus 7%, P<0.0001).

Additionally, extremely obese patients had higher rates of hypertension, dyslipidemia, and diabetes (P<0.0001 for all comparisons), and they were more likely to have a history of coronary intervention (41% versus 37%, P<0.0001).

The normal-weight group had higher rates of STEMI (19% versus 12%), cardiogenic shock (4% versus 2%), emergency PCI (20% versus 13%), and multivessel disease (41% versus 36%, P<0.0001 for all comparisons).

Extremely obese patients had a lower unadjusted in-hospital mortality (1.2% versus 2.0%). They also had lower rates of bleeding, periprocedural MI, cardiogenic shock, heart failure, and tamponade, but higher rates of renal failure and access-site hematoma.

After multiple variable adjustment, extremely obese patients had a mortality odds ratio of 1.14 versus normal-weight patients (95% CI 1.04-1.25, P=0.005). Bleeding rate remained lower in the obese patients (OR 0.80, 95% CI 0.76-0.83, P<0.001).

Radial access was more common in the obese patients (10% versus 5%) but did not influence mortality or bleeding risk in the adjusted analysis. Obese patients had a reduced risk of bleeding with femoral access (OR 0.79, P<0.001) and with radial access (OR 0.76, P=0.011).

Study limitations included lack of information on complications unrelated to PCI and the possibility of selection bias as the registry does not include all U.S. hospitals that perform PCI.

Implications for PCI Technique

Gurm and colleagues examined the prevalence of morbid obesity and implications for PCI by analyzing data from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium registry. The analysis included 227,044 patients who underwent PCI from 1998 to 2009.

The prevalence of morbid obesity increased from 4.38% in 1998 to 8.36% in 2009. As compared with overweight patients (BMI 25 to 30 kg/m2), morbidly obese patients had significantly higher (P<0.0001) rates of: Vascular complications: OR 1.31Contrast-induced nephropathy: OR 1.89Nephropathy requiring dialysis: OR 4.08Mortality: OR 1.63

"These epidemiological changes have important implications for technical considerations of cardiac catheterization, design of the catheterization lab to accommodate these patients, and most importantly, for societal effort toward prevention of obesity," Gurm and colleagues concluded.

The two major limitations of their study are the lack of randomization and the fact that it is observational.

The study by Daggubati's group was supported by the American College of Cardiology Foundation's National Cardiovascular Data Registry.

Daggubati disclosed relationships with Medtronic, Abbott, Eli Lilly, AstraZeneca, and Volcano.

Data for the study by Gurm's group came from a registry supported by Blue Cross Blue Shield of Michigan.

Gurm disclosed a relationship with Blue Cross Blue Shield of Michigan. Co-authors included an employee of Blue Cross Blue Shield of Michigan.

From the American Heart Association:

Primary source: Journal of the American College of Cardiology
Source reference:
Daggubati R, et al "In-hospital ooutcomes of percutaneous coronary interventions in extremely obese and normal weight patients: Findings from the NCDR" J Am Coll Cardiol 2013.

Additional source: Journal of the American College of Cardiology
Source reference:
Buschur ME, et al "The burgeoning epidemic of morbid obesity in patients undergoingn percutaneous coronary intervention: Insight from the Blue Cross Blue Shield of Michigan Cardiovascular Consortium" J Am Coll Cardiol 2013.

Charles Bankhead

Staff Writer

Working from Houston, home to one of the world's largest medical complexes, Charles Bankhead has more than 20 years of experience as a medical writer and editor. His career began as a science and medical writer at an academic medical center. He later spent almost a decade as a writer and editor for Medical World News, one of the leading medical trade magazines of its era. His byline has appeared in medical publications that have included Cardio, Cosmetic Surgery Times, Dermatology Times, Diagnostic Imaging, Family Practice, Journal of the National Cancer Institute, Medscape, Oncology News International, Oncology Times, Ophthalmology Times, Patient Care, Renal and Urology News, The Medical Post, Urology Times, and the International Medical News Group newspapers. He has a BA in journalism and MA in mass communications, both from Texas Tech University.

Tuesday, June 18, 2013

Outlier Hospitals May Cherry-Pick PCI Patients (CME/CE)

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By Charles Bankhead, Staff Writer, MedPage Today Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse PlannerPublic reporting of mortality after PCI might have led operators at outlier hospitals to shy away from high-risk patients.Point out that the findings add to a growing volume of evidence that public reporting of hospital performance data might result in unintended negative consequences for patient care, according to the author of an accompanying editorial.

Public reporting of mortality after percutaneous coronary interventions (PCI) might have led operators at outlier hospitals to shy away from high-risk patients, investigators concluded after reviewing more than 100,000 cases.

Predicted post-PCI mortality declined by almost 20% at Massachusetts hospitals identified as negative outliers by public-reporting data. Investigators found that the lower mortality resulted from a shift in the risk profile of patients undergoing PCI at the outlier hospitals, not improved clinical outcomes, as reported in the June issue of JACC: Cardiovascular Interventions.

"The risk profile of PCI patients at outlier institutions was significantly lower after public identification compared with non-outlier institutions, suggesting that risk-aversive behaviors among PCI operators at outlier institutions may be an unintended consequence of public reporting in Massachusetts," James McCabe, MD, of Harvard and Brigham and Women's Hospital in Boston, and co-authors concluded.

"Arguably, an aversion to performing PCI in the sickest patients at poorly performing hospitals is, in fact, the intended consequence of public reporting of PCI outcomes," they added. "However, the hospitals identified as negative outliers in Massachusetts were larger centers with greater average procedure volumes, features classically associated with superior technical performance."

The findings add to a growing volume of evidence that public reporting of hospital performance data might result in unintended negative consequences for patient care, according to the author of an accompanying editorial.

"Skeptics of public reporting voice many concerns about the accuracy and reliability of the information in reports and weaknesses in the risk-adjustment methods that are frequently used," wrote Gregory Dehmer, MD, of Texas A&M University Health Science Center in Temple. "There are additional concerns that the system could be 'gamed' by providers, and consumers could misinterpret data if they do not understand the terminology or context of a public report."

Public reporting of risk-adjusted in-hospital mortality after PCI came about as a means of building public trust and encouraging adoption of best practices. However, concern has arisen regarding the ability of public reporting to improve patient outcomes and at the same time preserving access to potentially lifesaving care, McCabe and colleagues noted.

Mortality for patients with ST-segment elevation myocardial infarction (STEMI) and shock declined in Massachusetts and in New York following implementation of public reporting. Some authorities have argued that the improvement resulted primarily from avoidance of high-risk patients, the authors continued.

Four hospitals have been identified as negative outliers since the beginning of public reporting in Massachusetts in 2003. Negative outlier refers to institutions that have risk-adjusted in-hospital mortality significantly greater than expected on the basis of risk-prediction models.

McCabe and colleagues hypothesized that PCI operators at outlier institutions might adopt a risk-averse approach to patient selection, which would lead to avoidance of high-risk patients.

"Paradoxically, these critically ill patients may stand the most to gain from reperfusion, albeit with a poor overall prognosis," the authors noted.

To examine trends in patient risk profiles at outlier hospitals, investigators reviewed data on 116,227 patients who underwent PCI at nonfederally funded hospitals in Massachusetts from 2003 to 2010.

By means of generalized estimating equations, the authors evaluated expected in-hospital mortality for the PCI patients. The Massachusetts reporting agency has developed separate prediction models for shock or STEMI (SOS) patients undergoing PCI and for not-shock, not-STEMI (non-SOS) patients. Averaged risk-adjusted expected mortality for each hospital is reported as standardized expected mortality incidence rates (SMIRs).

The primary endpoint of the analysis was the change in SMIRs for patients undergoing PCI at the four hospitals previously identified as negative outliers. The outlier hospitals were larger compared with non-outliers (P=0.03) and performed significantly more SOS and non-SOS PCI procedures each year (P<0.01).

The prevalence-weighted mean expected mortality for all cases was 1.38% (5.3% for SOS cases and 0.58% for non-SOS cases). Following public reporting of their negative outlier status, the four institutions subsequently had a significantly lower expected mortality as compared with non-outlier hospitals (1.08%, P<0.01), suggesting PCI patients at the four hospitals were less ill.

"Specifically, outlier institutions had significantly lower rates of expected mortality among non-SOS patients compared with non-SOS patients at non-outlier institutions (P<0.01), whereas illness severity of SOS patients ... did not appear to differ significantly," the authors reported.

Comparison of expected mortality at the four hospitals before and after identification of their outlier status showed even greater differences for SOS cases (7.49% versus 5.22%, P=0.03) and non-SOS cases (0.71% versus 0.47%, P<0.01).

Statewide, changes in expected in-hospital mortality derived from patient risk profiles paralleled actual observed in-hospital mortality (1.70% in 2003, 1.34% in 2010, P=0.02 for trend).

Moving forward, hospitals must find ways to satisfy demands for public reporting without leading the public to inappropriate conclusions or causing unintended harm, Dehmer said. He offered three suggestions for physicians: Adhere to guideline-directed therapyKnow and understand the performance measures applicable to their practice areasKnow how they compare with national benchmarks for key metrics

The findings underscore a message that has evolved over the past 2 decades, with respect to public reporting of outcome data, said Samin Sharma, MD, of Mount Sinai Medical Center in New York City, who was not involved in the study.

"Once you tell people about their outcomes, particularly if the outcomes are bad, they will improve outcomes by a system process and also, to a small extent, exclude some of the cases, which they otherwise would have done," Sharma told MedPage Today.

"We have learned that unless they are given the comparative data, everybody seems to feel or think that they're doing OK or doing good or doing the best," he added. "If you give them the data, everyone who becomes an outlier changes their practice. This has been shown by various institutions and by various services."

"Being transparent and reporting, in my opinion, will improve the overall quality of care and also patient selection," Sharma said. "Unless a patient is in imminent danger, there is nothing wrong with waiting on high-risk patients, particularly those with comorbid conditions. I am a strong proponent of that."

McCabe and co-authors reported no relevant conflicts of interest.

Dehmer reported no relevant conflicts of interest.

Primary source: JACC: Cardiovascular Interventions
Source reference:
McCabe JM, et al "Impact of public reporting and outlier status identification on percutaneous coronary intervention case selection in Massachusetts" JACC Cardiovasc Interv 2013; 6: 625-630.

Additional source: JACC: Cardiovascular Interventions
Source reference:
Dehmer GJ "Public reporting in interventional cardiology. The challenges ahead" JACC Cardiovasc Interv 2013; 6: 631-633.

Charles Bankhead

Staff Writer