Physician reviews of HM-related literature, including LOS in geriatric patients, outcomes of transcatheter aortic-valve implantation, renal ultrasound predictor for acute kidney injury, and romiplostim use in immune thrombocytopenia
by Elizabeth Schulwolf, MD, MA, Sean Greenhalgh, MD, Aziz Ansari, DO, FHM, Nathan Derhammer, MD, FAAP, Paula Marfia, MD, Elizabeth Wantuch, MD, MS, Division of Hospital Medicine, Loyola University, Chicago
A guide to this month’s studies
Clinical question: Is there an association between an early increase in ambulation and length of stay (LOS) in geriatric patients admitted with an acute illness?
Background: Early ambulation leading to better recovery in such illnesses as pneumonia and myocardial infarction is well known, as is early ambulation after hip fracture surgery to prevent complications. However, no specific guidelines exist in regard to ambulation in older patients.
Study design: Prospective, nonblinded study.
Setting: Acute-care geriatric unit in an academic medical center.
Synopsis: A total of 162 patients 65 or older were studied. Data were collected during a four-month period in 2009. A Step Activity Monitor (SAM) was placed on admission. Patients were instructed to walk as usual. Investigators measured the number of steps taken per day and change in steps between the first and second day.
Patients averaged 662.1 steps per day, with a mean step change of 196.5 steps. The adjusted mean difference in LOS for patients who increased their total steps by 600 or more between the first and second day was 2.13 days (95% CI, 1.05-3.97). Patients who had low or negative changes in steps had longer LOS. The 32 patients who walked more than 600 steps were more likely to be men (P=0.02), independently ambulate (P<0.01), and have admitting orders of “ambulate with assist” (P=0.03).
One limitation of this study is that patients who walked more might have been less ill or very functional on admission.
Bottom line: Increasing ambulation early in a hospitalization (first two days) is associated with a decreased LOS in an elderly population.
Citation: Fisher SR, Kuo YF, Graham JE, Ottenbacher KJ, Ostir GV. Early ambulation and length of stay in older adults hospitalized for acute illness. Arch Intern Med. 2010;170(21):1942-1943.
Clinical question: As hospitals focus more on programs to improve patient safety, has the rate of harms decreased?
Background: Since the Institute of Medicine published a groundbreaking report (To Err is Human) a little more than a decade ago, policymakers, hospitals, and healthcare organizations have focused more on efforts to improve patient safety with the goal of reducing harms. It is not clear if these efforts have reduced harms.
Study design: Retrospective chart review.
Setting: Ten hospitals in North Carolina.
Synopsis: Ten charts per quarter were randomly selected from each hospital from January 2002 through December 2007. Internal and external reviewers used the IHI Global Trigger Tool for Measuring Adverse Events to identify rates of harm. Harms were classified into categories of severity and assessed for preventability.
Kappa scores were generally higher for internal reviewers, indicating higher reliability for internal reviewers. Internal reviewers identified 588 harms for 10,415 patient days (25.1 harms per 100 patient days), which occurred in 423 unique patients (18.1%). A majority (63.1%) of harms were considered preventable. Forty-one percent of harms were temporary and required intervention; 2.4% caused or contributed to a patient’s death.
There was no significant change over time in the rate of harms (regardless of reviewer type) even after adjusting for demographics.
This study is limited because it is based only in North Carolina hospitals. It was not powered to evaluate change in individual hospitals. There might have been unmeasurable improvements that were not accounted for by the trigger tool.
Bottom line: Despite a higher focus on patient safety, investigators did not find a decrease in the rate of harms. A majority of the harms were preventable. This study should not preclude efforts to continue to improve patient safety.
Citation: Landrigan CP, Parry GJ, Bones CB, Hackbarth AD, Goldmann DA, Sharek PJ. Temporal trends in rates of patient harm resulting from medical care. N Engl J Med. 2010;363(22):2124-2134.
Clinical question: Does the combination of diet modification and increased physical activity lead to weight loss and improve health risks in severely obese patients?
Background: Obesity is at epidemic proportions, but there are no evidence-based treatment guidelines for severe obesity.
Study design: Randomized, single-blind trial.
Setting: Community volunteers.
Synopsis: A total of 130 individuals with a body mass index (BMI) of ≥35 were randomized to receive lifestyle interventions consisting of diet and initial physical activity for 12 months, or diet for six months and delayed physical activity for the remainder of the year.
The initial-physical-activity group demonstrated greater weight loss at six months, but the overall weight loss did not differ between the two groups. At 12 months, the initial physical activity group lost 12.1 kg and the delayed-physical-activity group lost 9.87 kg. Both groups demonstrated significantly reduced blood pressure, reduced serum liver enzymes, and improved insulin resistance.
Candidates with a history of coronary artery disease, uncontrolled blood pressure, or diabetes were excluded. Participants were provided with prepackaged meal replacements for the first six months and received financial compensation for participation in the study.
This study is limited by the fact that a majority of the participants were female (85.1%). Providing meals to the participants also limits the application of this program to the general public.
Bottom line: The results of this study reflect the importance of diet and exercise on weight loss in obese individuals. However, adherence to the goals of the study required multiple individual and group meetings throughout the year, the provision of prepackaged meals, and some financial incentive for compliance.
Citation: Goodpaster GH, Delany JP, Otto AD, et al. Effects of diet and physical activity interventions on weight loss and cardiometabolic risk factors in severely obese adults: a randomized trial. JAMA. 2010;304 (16):1795-1802.
Clinical question: Is there a mortality benefit to transcatheter valve implantation over standard therapy in nonsurgical candidates with severe aortic stenosis (AS)?
Background: Untreated, symptomatic AS has a high rate of death, but a significant proportion of patients with severe aortic stenosis are poor surgical candidates. Available since 2002, transcatheter aortic-valve implantation (TAVI) is a promising, nonsurgical treatment option for severe AS. However, to date, TAVI has lacked rigorous clinical data.
Study design: Prospective, multicenter, randomized, active-treatment-controlled clinical trial.
Setting: Twenty-one centers, 17 of which were in the U.S.
Synopsis: A total of 358 patients with severe AS who were considered nonsurgical candidates were randomized to either TAVI or standard therapy. A majority (83.8%) of the patients in the standard group underwent balloon aortic valvuloplasty.
Researchers found a significant reduction (HR 0.55, 95% CI 0.40 to 0.74, P<0.001) in all-cause mortality at one year in those patients undergoing TAVI (30.7%) vs. standard therapy (50.7%). Additional benefits included lower rates of the composite endpoints of death from any cause or repeat hospitalization (42.5% vs. 71.6%, P<0.001) and NYHA Functional Class III or IV symptoms (25.2% vs. 58.0%, P<0.001) at one year. However, higher incidences of major strokes (5.0% vs. 1.6%, P=0.06) and major vascular complications (16.2% vs. 1.1%, P<0.001) were seen.
While the one-year mortality benefit of TAVI over standard nonoperative therapy was clearly demonstrated by this study, hospitalists should interpret these data cautiously with respect to their inpatient populations as exclusion criteria were extensive, including bicuspid or noncalcified aortic valve, LVEF less than 20%, and severe renal insufficiency. Additionally, the entity of standard therapy was poorly delineated.
Bottom line: TAVI should be considered in patients with severe aortic stenosis who are not suitable surgical candidates.
Citation: Leon MB, Smith CR, Mack M, et al. Transcatheter aortic-valve implantation for aortic stenosis in patients who cannot undergo surgery. N Engl J Med. 2010;363(17):1597-1607.
Clinical question: Are current Medicare hospice eligibility guidelines accurate enough to predict six-month survival in nursing home residents with dementia when compared with the Advanced Dementia Prognostic Tool (ADEPT)?
Background: Incorrectly estimating the life expectancy in almost 5 million nursing home residents with dementia prevents enrollment to palliative care and hospice for those who would benefit most. Creating and validating a mortality risk score would allow increased services to these residents.
Study design: Prospective cohort study.
Setting: Twenty-one nursing homes in Boston.
Synopsis: A total of 606 nursing home residents with advanced dementia were recruited for this study. Each resident was assessed for Medicare hospice eligibility and assigned an ADEPT score. Mortality rate was determined six months later. These two assessment tools were compared regarding their ability to predict six-month mortality.
The mean ADEPT score was 10.1 (range of 1.0-32.5), with a higher score meaning worse prognosis. Sixty-five residents (10.7%) met Medicare hospice eligibility guidelines. A total of 111 residents (18.3%) died.
The ADEPT score was more sensitive (90% vs. 20%) but less specific (28.3% vs. 89%) than Medicare guidelines. The area under the receiver operating characteristic (AUROC) curve was 0.67 (95% CI, 0.62-0.72) for ADEPT and 0.55 (95% CI, 0.51-0.59) for Medicare.
ADEPT was slightly better than hospice guidelines in predicting six-month mortality.
This study was limited in that the resident data were collected at a single random time point and might not reflect reality, as with palliative care and hospice, there usually is a decline in status that stimulates the referrals.
Bottom line: The ADEPT score might better estimate the six-month mortality in nursing home residents with dementia, which can help expand the enrollment of palliative care and hospice for these residents.
Citation: Mitchell SL, Miller SC, Teno JM, Kiely DK, Davis RB, Shaffer ML. Prediction of 6-month survival of nursing home residents with advanced dementia using ADEPT vs hospice eligibility guidelines. JAMA. 2010;304(17):1929-1935.
Clinical question: How do residents believe the forthcoming revised ACGME Rules for Supervision and Duty Hours will impact their residency?
Background: On July 1, revised ACGME duty-hour rules go into effect, limiting PGY-1 residents to 16-hour duty periods and PGY-2 and above to 28 hours. The effect these recommendations will have on patient care and resident education is unknown.
Study design: Twenty-question electronic, anonymous survey.
Setting: Twenty-three medical centers in the U.S., including residents from all disciplines and years in training.
Synopsis: Twenty-two percent of residents responded to the survey (n=2,521). Overall, 48% of residents disagreed with this statement: “Overall the changes will have a positive effect on education,” while only 26% agreed. Approximately half of those surveyed agreed that the revisions would improve their quality of life, but the same percentage also believed the revisions would increase the length of their residencies.
Residents reacted negatively to the idea that the proposed changes would improve patient safety and quality of care delivered, promote education over service obligations, and prepare them to assume senior roles. In free-text comments, residents expressed concerns about an increased number of handoffs and decreased continuity of care.
While the sample size is large and diverse, results of this survey can be affected by voluntary response bias and, therefore, could be skewed toward more extreme responses (in this case, more negative responses). The wide distribution of the responses suggests this might not be the case.
Bottom line: Residents do not believe the new requirements—though they could improve their quality of life—will positively impact patient care and education.
Citation: Drolet BC, Spalluto LB, Fischer SA. Residents’ perspectives on ACGME regulation of supervision and duty hours—a national survey. N Engl J Med. 2010;363(23):e34(1)-e34.
Clinical question: Can a clinical prediction rule aid clinicians in deciding when to order a renal ultrasound (RUS) in hospitalized patients with acute kidney injury?
Background: RUS routinely is obtained in patients admitted with acute kidney injury (AKI) to rule out obstruction as a cause of AKI. It is not known if this test adds any additional information in the routine evaluation of AKI and if obtaining the test is cost-effective.
Study design: Cross-sectional study.
Setting: Yale-New Haven Hospital in Connecticut.
Synopsis: This study evaluated 997 inpatients with AKI who underwent RUS. Outcome events were RUS identification of hydronephrosis (HN) or hydronephrosis requiring intervention (HNRI). The patients were divided into two samples: 200 in derivation sample and 797 in validation sample. The derivation sample was used to identify specific factors associated with HN. Seven clinical variables were identified and were used to create three risk groups: low, medium, and high.
In the validation sample, 10.6% of patients had HN and 3.3% had HNRI. The negative predictive value for HN was 96.9%, sensitivity 91.8%, and negative likelihood ratio 0.27. The number needed to screen (NNS) low-risk patients for HN was 32 and 223 for HNRI. Based on their findings, if the patient was classified low-risk, clinicians might be able to delay or avoid ordering RUS.
The major limitation of this study was that it was based at a single institution. This study only evaluated RUS obtained in patients who were hospitalized and might not be applicable to outpatients.
Bottom line: RUS was not found to change clinical management in patients with AKI and classified as low-risk for HN. Limiting RUS to patients who are high-risk for obstruction will increase the chance of finding useful clinical information that can change management decisions and limit cost of unnecessary testing.
Citation: Licurse A, Kim MC, Dziura J, et al. Renal ultrasonography in the evaluation of acute kidney injury: developing a risk stratification framework. Arch Intern Med. 2010;170(21):1900-1907.
Clinical question: Does the use of romiplostim lead to increased platelet counts and lower rates of splenectomy and other adverse events when compared with standard therapy in patients with immune thrombocytopenia?
Background: Romiplostim is a thrombopoetin mimetic used to increase platelet counts in immune thrombocytopenia. Initial treatments for this disease involve glucocorticoids or intravenous immune globulin. Most patients require second-line medical or surgical therapies, including splenectomy.
Study design: Randomized, open-label controlled trial.
Setting: Eighty-five medical centers in North America, Europe, and Australia.
Synopsis: A total of 234 patients were randomized in a 2:1 ratio to receive either romiplostim or the medical standard of care. Co-primary endpoints were the incidence of treatment failure and the incidence of splenectomy; secondary endpoints included time to splenectomy, platelet count, platelet response, and quality of life. Treatment failure was defined as a platelet count of 20x109 per liter or lower for four weeks, or a major bleeding event.
At the end of 52 weeks, patients receiving romiplostim had higher platelet counts, fewer bleeding events, less need for splenectomy (9% vs. 36%), and a better quality of life.
The short-term use of romiplostim in this study was not associated with an increase in adverse events when compared with standard therapy. However, maintenance of the elevated platelet count, which results from romiplostim treatment, requires continuous use of the drug; the long-term effects are unknown.
Bottom line: In patients with immune thrombocytopenia, romiplostim leads to increased platelet counts, decreased bleeding events, and decreased need for splenectomy compared to standard of care. However, the cost of the medication, when compared with current therapies, could be prohibitive.
Citation: Kuter DJ, Rummel M, Boccia R, et al. Romiplostim or standard of care in patients with immune thrombocytopenia. N Engl J Med. 2010;363(20):1889-1899. TH
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