In the News
for the Week of 8-17-10
- Vena cava filters might fracture, embolize
- New RA criteria focus on early indicators to prevent later damage
- MKSAP Quiz: kidney stone prevention
- Disclosing medical errors does not increase malpractice claims
- Age, disability among indicators of medication adherence 3 months after stroke
- Invasive MRSA rates dropped dramatically
From ACP Foundation
- Free patient resource on adult vaccines available
Cartoon caption contest
- Put words in our mouth
Physician editor: Darren Taichman, FACP
Vena cava filters might fracture, embolize
When patients have retrievable inferior vena cava (IVC) filters implanted but not removed, there is a risk of serious cardiac events, a new study and a communication from the FDA warn.
Physicians at York Hospital in Pennsylvania conducted a retrospective study of all of their patients who had received a Bard Recovery or Bard G2 filter between April 2004 and January 2009, after one patient required open-heart surgery to retrieve a fractured filter. Patients who had died or had filters removed were eliminated, leaving 80 patients in the trial.
The patients underwent fluoroscopy to assess the integrity of their filters. The testing revealed strut fractures in 13 (or 16%) of the patients. Of the 28 Bard Recovery filters studied, seven (or 25%) had fractured, and fragments had embolized to the heart in five of those seven patients. Three patients experienced ventricular tachycardia and/or tamponade, including one case of sudden death during the study. There were 52 of the newer Bard G2 filters in the study, and 6 (or 12%) fractured, resulting in two cases of asymptomatic end-organ fragmentation.
Although the results would appear to indicate that the Bard G2 is associated with less fracture risk, the study authors cautioned against that interpretation, because the Bard Recovery filters had been implanted earlier. If the prevalence of fractures observed with the Bard G2 was extrapolated to the 50 months that the Bard Recovery was observed, the rate would be the same, the authors noted.
The authors also expressed concerns about the difficulty of removing the filters after local fibrosis, and noted that implantation of these specific devices has been halted at their institution. They urged other physicians and medical centers to evaluate patients who have received the filters, warning that the symptoms of perforation of the heart resulting from filter fracture are similar to those of pulmonary embolism (PE), and could be misdiagnosed as a recurrence.
An accompanying commentary called for closer and more public scrutiny of such devices during the FDA approval process. The article and commentary were published online by Archives on Internal Medicine on Aug. 9.
The same day, the FDA issued an initial communication about retrievable IVC filters, recommending that removal of the filters be considered as soon as protection from PE is no longer needed. Since 2005, the agency has received 921 adverse event reports about IVC filters, of which 328 involved device migration, 146 involved embolizations, 70 involved perforation of the IVC, and 56 involved filter fracture..
New RA criteria focus on early indicators to prevent later damage
New criteria for rheumatoid arthritis (RA) seek to redefine the disease by early indicators, allowing for earlier treatment to prevent joint damage in later disease stages.
The new criteria, developed jointly by the American College of Rheumatology (ACR) and the European League against Rheumatism, replace existing criteria published in 1987, which focused on established rather than early indicators of disease. They were jointly published in the September Arthritis & Rheumatism and the September Annals of the Rheumatic Diseases.
The work focused on identifying, among patients newly presenting with undifferentiated inflammatory synovitis, factors that best discriminated between those who were and those who were not at high risk for persistent and/or erosive disease.
The new criteria classify “definite RA” as:
- confirmed presence of synovitis in at least one joint,
- absence of an alternative diagnosis to explain the synovitis, such as gout or infection, and
- a combined score of 6 or more out of 10 from each of the following four domains:
- number and sites of affected joints (range, 0 to 5),
- blood test results for autoantibodies indicative of RA (range, 0 to 3),
- evidence of an increase in inflammatory proteins (range, 0 to 1), and
- duration of symptoms (range, 0 to 1).
The 2010 criteria focus on early diagnosis and treatments that are effective in earlier stages of the disease, such as disease-modifying antirheumatic drugs.
The authors wrote, "The criteria are meant to be applied only to eligible patients, in whom the presence of obvious clinical synovitis in at least one joint is central. They should not be applied to patients with mere arthralgia or to normal individuals. However, once definite clinical synovitis has been determined (or historical documentation of such has been obtained)…a more liberal approach is allowed for determining the number and distribution of involved joints, which permits the inclusion of tender or swollen joints."
For information on how general internal medicine physicians can partner with subspecialists to manage RA and its associated cardiovascular, cancer or infection risks, read the cover story in the current issue of ACP Internist.
MKSAP Quiz: kidney stone prevention
A 22-year-old woman comes for a routine office visit. Medical history is insignificant, and she takes no medications. Her father and brother have kidney stones caused by high levels of urine calcium. She has increased her fluid intake.
On physical examination, vital signs are normal. BMI is 27.
|Blood urea nitrogen||10 mg/dL (3.6 mmol/L)|
|Serum creatinine||0.7 mg/dL (61.9 µmol/L)|
|Urinalysis||pH 5.0; no protein or blood|
Which of the following is the most appropriate next step in this patient’s management?
A) Add a calcium supplement
B) Decrease dietary animal protein intake
C) Increase dietary calcium intake
D) Increase dietary sucrose intake
Click here or scroll to the bottom of the page for the answer and critique.
Disclosing medical errors does not increase malpractice claims
The University of Michigan Health System (UMHS) has fully disclosed and offered compensation to patients for medical errors without increasing its total claims and liability costs, a report said.
An analysis funded by Blue Cross Blue Shield of Michigan Foundation and published in the Aug. 17 Annals of Internal Medicine found a decrease in new legal claims, number of lawsuits per month, time to claim resolution, and costs after implementation of the program of disclosure with offer of compensation.
In 2001, UMHS launched a comprehensive claims management program that centered on full disclosure for medical errors. Under this model, UMHS proactively looked for medical errors, fully disclosed found errors to patients, and offered compensation when at fault.
Changes in rates of claims before and after program implementation (from 1995 to 2007) were statistically significant only for claims that resulted in a lawsuit. The UMHS experienced 232 lawsuits (38.7 per year) before and 106 (17.0 per year) after program implementation. A decrease was still evident, assuming all cases that were open at the end of the observation period (1 before and 35 after implementation) resulted in lawsuits, with 233 lawsuits (38.8 per year) before and 141 lawsuits (22.6 per year) after program implementation.
Monthly lawsuit rates decreased from 2.13 (95% CI, 1.58 to 2.67) per 100,000 patient encounters before to 0.75 (95% CI, 0.47 to 1.03) per 100,000 patient encounters after full implementation (rate ratio [RR], 0.35 [95% CI, 0.22 to 0.58]). The trend was significant (difference in trend, −0.028; 95% CI, −0.054 to −0.001]; P=0.04)
After full implementation of a disclosure-with-offer program, the average monthly rate of new claims decreased from 7.03 to 4.52 per 100,000 patient encounters. The average monthly rate of lawsuits decreased from 2.13 to 0.75 per 100,000 patient encounters. Median time from claim reporting to resolution decreased from 1.36 years to 0.95 year. Average monthly cost rates decreased for total liability, patient compensation, and non-compensation-related legal costs.
Median and mean total liability costs decreased after full program implementation (RR for mean costs, 0.41; 95% CI, 0.26 to 0.66; P<0.001), attributable to decreases in both legal and patient compensation costs. After initial program implementation, total cost rates significantly decreased (P=0.014) as did legal and patient compensation costs (P=0.004 and P=0.024, respectively) costs. Although the total costs associated with lawsuits decreased after full implementation, the total costs for nonlawsuit claims did not.
Limitations include that the retrospective study design cannot establish causality. Also, malpractice claims generally declined in Michigan toward the end of the study period, and the findings might not apply to other health systems, given that UMHS has a closed staff model covered by a captive insurance company and often assumes legal responsibility.
Age, disability among indicators of medication adherence 3 months after stroke
Age, stroke-related disability, and several other factors indicate whether a patient will continue adhering to discharge medications three months after a stroke, a new study has found.
The AVAIL (Adherence Evaluation After Ischemic Stroke–Longitudinal) investigators analyzed data from hospitals participating in the Get with the Guidelines–Stroke program to determine what variables were associated with long-term medication adherence after hospital discharge for stroke. The main outcome measures were regimen persistence from discharge to three months for five classes of medications (antiplatelet therapies, warfarin, antihypertensive therapies, lipid-lowering therapies or diabetes medications) and reasons for nonpersistence. The study results were published online Aug. 9 by Archives of Neurology.
Overall, 2,598 patients at 106 U.S. hospitals were included in the study analysis. Of these, 75.5% continued to take all of the stroke prevention medications prescribed at discharge three months later. Patients were most likely to continue taking antihypertensive and antiplatelet medications. Patients who were older, had less severe stroke-related disability, had been prescribed fewer discharge medications, and had insurance were more likely to continue taking their medications. Patients who understood why they were taking the medications and how to get them refilled were also more likely to take them long-term. Better quality of life, greater financial hardship, working status, geographic region and hospital size were also associated with adherence at three months.
The authors noted that although about three-quarters of patients did continue taking their stroke prevention medications three months after discharge, about a quarter did not. They also pointed out that rates might be worse at hospitals not participating in Get with the Guidelines, which might not be as focused on stroke care. Although their study had limitations, including limited generalizability, use of self-reported data, and lack of information on clinician visits at three months, they concluded that long-term adherence to stroke medications depends on many factors, some of them modifiable. Using their data, they wrote, "We can begin to develop and evaluate strategies to improve appropriate use of evidence-based therapies and reduce the risk of recurrent stroke."
Invasive MRSA rates dropped dramatically
Rates of health care-associated invasive methicillin-resistant Staphylococcus aureus (MRSA) declined substantially between 2005 and 2008, according to a CDC surveillance program.
Between 2005 and 2008, 21,503 invasive MRSA infections were reported to the CDC’s Active Bacterial Core surveillance program. Of these, 17,508 were health care associated. In 2005, the incidence rate of hospital-onset invasive MRSA infections was 1.02 per 10,000 population. Over the next three years, that rate decreased by 9.4% per year. The incidence of health-care associated community-onset infections (which were defined as infections that could be linked to recent health care exposure but occurred in outpatients or patients recently admitted to the hospital) was 2.20 per 10,000. That rate declined by 5.7% per year during the study period.
The majority of the reported infections were MRSA bloodstream infections, and the greatest decreases were also seen in this subset (hospital-onset, −11.2%; community-onset, −6.6%). Decreased infection rates were also observed in the subset of patients who were on dialysis, comparable to the overall decreases. The results were published in the Aug. 11 Journal of the American Medical Association.
The study authors concluded that these significant declines in invasive MRSA infections (overall about 28% for hospital-onset and 17% for community-onset) could potentially be attributed to MRSA prevention practices in hospitals, and they noted that the results complement previous small studies that have found positive effects from infection prevention interventions. The greater decrease seen in the hospital compared with the community could also support this conclusion.
However, an accompanying editorial noted that the decreases pre-date many MRSA prevention efforts, and may instead be due to general infection control efforts, such as improved hand hygiene and central line management. In fact, the finding of widespread, continued decreases could have confounded the results of any before-after study that tested MRSA prevention efforts. The decreases could also be due to a natural biological trend rather than any intervention at all, the editorialists wrote. They called for more detailed and broader surveillance of MRSA and other similar pathogens to help establish explanations for this study’s findings.
From ACP Foundation.
Free patient resource on adult vaccines available
The ACP Foundation recently launched free new tool, HEALTH NoTES, to facilitate physician-patient communication around adult vaccines. The tool contains key information that reinforces physician messages and helps patients and family members understand what vaccines they may need. More information and ordering instructions are available on the ACP Foundation Web site.
Cartoon caption contest.
Put words in our mouth
ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.
E-mail all entries to firstname.lastname@example.org. ACP staff will choose finalists and post them online for an online vote by readers. The winner will appear in an upcoming edition..
MKSAP answer and critique
The correct answer is C) Increase dietary calcium intake. This item is available to MKSAP 15 subscribers as item 57 in the Nephrology module.
An estimated 33% of patients with kidney stones have a family history of stone formation, and most of these stones are caused by hypercalciuria. This patient is therefore at increased risk for stone formation, and the most appropriate next step in management is an increase in her dietary calcium intake. Calcium oxalate stones can develop when calcium binds to oxalate in the urine. Adherence to a high-calcium diet (generally defined as 1 to 4 g/d of calcium) has been shown to decrease the risk of calcium oxalate stone formation by binding calcium to oxalate in the gut and preventing oxalate absorption and its filtration into the urine.
Calcium supplementation in addition to or in place of increased dietary calcium intake has not been shown to decrease the risk of kidney stone formation. Furthermore, calcium carbonate supplementation with meals may be associated with slightly increased rates of stone formation.
Animal protein intake contributes to increased purine metabolism and uric acid production and has been associated with uric acid stone formation. Animal protein ingestion also leads to decreases in urine citrate and increases in urine calcium. In a randomized, controlled trial to prevent stone formation, a diet with increased calcium content and reduced animal protein and salt was shown to effectively decrease stone recurrence in men with hypercalciuria compared with a reduced-calcium diet; however, this intervention has not been shown to prevent the incidence of calcium stones in women, and a low-protein diet alone has not been shown to reduce calcium stone formation in either men or women.
Increased dietary intake of sucrose appears to increase urine calcium excretion independent of calcium intake and has been shown to increase the risk of incident kidney stones in women. This intervention would not be recommended for a patient at risk for stone formation.
- Adherence to a high-calcium diet (generally defined as 1 to 4 g of calcium per day) has been shown to decrease the risk of incident and recurrent calcium oxalate stone formation.
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A 30-year-old woman is evaluated for a 1-year history of fatigue, headaches, poor sleep, depression, intermittently blurred vision, and weakness when climbing stairs. She takes no medication.
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