Nasal Spray Flu Vaccine Ineffective and Not Recommended

MedicalResearch.com Interview with:

Michael Jackson  PhD, MPH Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network

Dr. Jackson

Michael Jackson  PhD, MPH
Kaiser Permanente Washington Health Research Institute (KPWHRI) principal investigator for the United States Influenza Vaccine Effectiveness Network 

MedicalResearch.com: What is the background for this study?

  • Response: Each year, Kaiser Permanente Washington is one of five sites across the country that participate in the United States Influenza Vaccine Effectiveness Network. The Network reports its early interim results in the MMWRand presents additional interim results to the Advisory Committee on Immunization Practices (ACIP)This New England Journal of Medicine publication is an update of those interim results.
  • The findings in this New England Journal of Medicine are special because prior randomized controlled trials indicated that the nasal spray vaccine (FluMist)—also called live attenuated influenza vaccine (LAIV)—would work well to protect children and teens from the flu, whereas in actual practice we found that the flu shot worked much better, particularly against the predominant strain, A(H1N1)pdm09.
  • The nasal spray vaccine was first seen to be less effective for young children than the flu shot in 2013-2014 for the A(H1N1)pdm09 virus strain. In response, the A(H1N1)pdm09 virus strain used in the nasal spray vaccine was changed for the 2015-2016 influenza season. The 2016/17 season was the first since 2015-2016 to be dominated by the A(H1N1)pdm09 virus, making this our first opportunity to evaluate the updated nasal spray vaccine.
  • The Influenza Vaccine Effectiveness Network evaluated the impact of this change as part of our estimates of influenza vaccine effectiveness in 2015-2016. Preliminary findings from this study were presented to the ACIP in June 2016, which led to the nasal spray vaccine not being recommended in 2016-2017 in the US, although the nasal spray vaccine remains licensed in the US. In 2016-2017, the LAIV A(H1N1)pdm09 vaccine strain was unchanged from 2015-2016.

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Higher HIV Viral Loads Linked to Increased Squamous Cell Cancers of Skin

MedicalResearch.com Interview with:

Maryam M. Asgari, MD, MPH Department of Dermatology, Massachusetts General Hospital, Department of Population Medicine Harvard Medical School, Boston, Massachusetts Division of Research, Kaiser Permanente Northern California, Oakland

Dr. Asgari

Maryam M. Asgari, MD, MPH
Department of Dermatology
Massachusetts General Hospital,
Department of Population Medicine
Harvard Medical School, Boston, Massachusetts
Division of Research, Kaiser Permanente
Northern California, Oakland

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Nonmelanoma skin cancer – defined as basal cell carcinoma (BCC) and squamous cell carcinoma (SCC) – is a common malignant condition, affecting more than 2 million Americans every year. BCCs are more common than SCCs among individuals with healthy immune systems, while SCCs are more predominate than BCCs among people who are immunocompromised.

We examined how laboratory markers used to evaluate HIV disease progression may be associated with subsequent nonmelanoma skin cancer risk in white patients previously diagnosed with at least one such cancer from 1996 to 2008.  We measured CD4 count, viral load and subsequent nonmelanoma skin cancer. The study included 455 participants with HIV and 1,952 without HIV. All were members of the Kaiser Permanente Northern California health care plan.

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Many CT Scans Can Be Avoided During ER Evaluation of Head Trauma

MedicalResearch.com Interview with:

Adam L. Sharp MD MS Research Scientist/Emergency Physician Kaiser Permanente Southern California Kaiser Permanente Research Department of Research & Evaluation Pasadena, CA 91101

Dr. Adam Sharp

Adam L. Sharp MD MS
Research Scientist/Emergency Physician
Kaiser Permanente Southern California
Kaiser Permanente Research
Department of Research & Evaluation
Pasadena, CA 91101

MedicalResearch.com: What is the background for this study?

Response: Millions of head computed tomography (CT) scans are ordered annually in U.S. emergency Departments (EDs), but the extent of avoidable imaging is poorly defined. Ensuring appropriate use is important to ensure patient outcomes and limited resources are optimized. A large number of stake holders have highlighted the need to reduce “unnecessary” CT scanning as part of their recommendations for the Choosing Wisely campaign. However, despite calls for improved stewardship, the extent of avoidable CT use among adults with minor trauma in community EDs is not known.

The Canadian CT Head Rule (CCHR) is perhaps the most studied of many validated decision instruments designed to assist providers in evaluating patients with minor head trauma. This study aims to describe the scope of overuse of CT imaging by ED providers in cases where application of the CCHR could have avoided imaging.

Secondarily, we sought to describe the extent to which avoidable CTs, if averted, would have resulted in “missed” intracranial hemorrhages requiring a neurosurgical intervention.

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Infections in Infancy, Not Antibiotics Associated With Childhood Obesity

MedicalResearch.com Interview with:

De-Kun Li, MD, PhD Senior Research Scientist Division of Research Kaiser Foundation Research Institute Kaiser Permanente Oakland, CA 94612

Dr. De-Kun Li,

De-Kun Li, MD, PhD
Senior Research Scientist
Division of Research
Kaiser Foundation Research Institute
Kaiser Permanente
Oakland, CA 94612

MedicalResearch.com: What is the background for this study?

Response: The composition of gut microbia (microbiome) has emerged as a key contributor to human disease risk. The external influence on the composition of microbiome in early childhood, especially in infancy, has been linked to increased risk of childhood obesity. Several studies have examined use of antibiotics in infancy and reported an association between use of antibiotics and increased risk of childhood obesity. This has caused a great uncertainty among both pediatricians and parents regarding treatment of infant infections. However, the previous studies failed to separate the effect of underlying infections for which antibiotics were used from the effect of the antibiotics itself. The contribution of our study was to examine the effects of infections and antibiotic use separately.

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Compared To Other Blood Pressure Medications Diuretics Have Bone Protective Effect

MedicalResearch.com Interview with:

Joshua I. Barzilay, MD Kaiser Permanente of Georgia Duluth, GA 30096

Dr. Joshua I. Barzilay

Joshua I. Barzilay, MD
Kaiser Permanente of Georgia
Duluth, GA 30096

MedicalResearch.com: What is the background for this study?

Response: Hypertension (HTN) and osteoporosis (OP) are age-related disorders. Both increase rapidly in prevalence after age 65 years. Prior retrospective, post hoc studies have suggested that thiazide diuretics may decrease the risk of osteoporosis. These studies, by their nature, are open to bias. Moreover, these studies have not examined the effects of other anti HTN medications on osteoporosis.

Here we used a prospective blood pressure study of ~5 years duration to examine the effects of a thiazide diuretic, a calcium channel blocker and an ACE inhibitor on hip and pelvic fractures. We chose these fractures since they are almost always associated with hospitalization and thus their occurrence can be verified.

After the conclusion of the study we added another several years of follow up by querying medicare data sets for hip and pelvic fractures in those participants with medicare coverage after the study conclusion.

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5ARIs Found Not Linked To Increased Prostate Cancer Mortality

MedicalResearch.com Interview with:

Lauren P. Wallner, PhD, MPH Assistant Professor, Departments of Medicine and Epidemiology, University of Michigan Adjunct Investigator, Kaiser Permanente Southern California North Campus Research Complex Ann Arbor, MI

Dr. Lauren P. Wallner

Lauren P. Wallner, PhD, MPH
Assistant Professor, Departments of Medicine and Epidemiology, University of Michigan
Adjunct Investigator
Kaiser Permanente Southern California
North Campus Research Complex
Ann Arbor, MI

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: 5 alpha-reductase inhibitors (5ARIs) are often used for the management of lower urinary tract symptoms in men. Two prior clinical trials found 5ARIs also reduced the risk of prostate cancer, but there was an increase in more aggressive (Gleason 7-10) cancers among the men who were diagnosed. Thus, concerns over whether 5ARIs may increase the risk of prostate cancer death have limited their use in the prevention of prostate cancer, which remains controversial. To address the safety of 5ARIs for the primary prevention of prostate cancer, we conducted a large population-based study of over 200,000 men in community practice settings of over a 19 year observation period to assess whether 5ARI use (as compared to alpha-blocker use) was associated with prostate cancer mortality.

Our results suggest that 5ARI use was not associated with an increased risk of prostate cancer mortality when compared to alpha-blocker use.

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Many Elderly Patients Not Receiving Adequate Colon Cancer Screening or Follow Up

MedicalResearch.com Interview with:

Carrie N. Klabunde, PhD Office of Disease Prevention Office of the Director NIH Rockville MD

Dr. Carrie Klabunde

Carrie N. Klabunde, PhD
Office of Disease Prevention
Office of the Director
NIH
Rockville MD

MedicalResearch.com: What is the background for this study? What are the main findings?

Response: Many studies of colorectal cancer screening focus on adults 50-75 years of age; few specifically look at screening in the elderly. We wanted to examine colorectal cancer screening use, including follow-up diagnostic testing for those with abnormal fecal blood screening tests, in adults 65 years of age and older. We also wanted to assess whether screening use in this population is influenced more by elderly individual’s chronological age, or their health status (called comorbidity in our study). The study was conducted in three large, integrated healthcare systems: Kaiser Permanente in Northern California and Southern California, and Group Health in Washington state and Idaho. We examined data on nearly 850,000 patients aged 65-89.

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Study Finds Small Link Between Phototherapy and Infantile Cancer

MedicalResearch.com Interview with:

Dr-Andrea-Wickremasinghe

Dr. Andrea Wickremasinghe

Andrea C. Wickremasinghe, MD
Neonatologist
Kaiser Santa Clara California

MedicalResearch.com: What is the background for this study?

Response: Neonatal jaundice is common and is often treated with phototherapy. Phototherapy is typically considered to be benign. In the past decade, phototherapy use has increased and it is sometimes started at bilirubin levels below recommended treatment thresholds. Beginning in the 1970’s, in-vitro and in-vivo studies have shown phototherapy to be associated with cellular changes implicated in the pathogenesis of cancer. Epidemiologic studies have yielded mixed results, with some studies showing associations between phototherapy and leukemia and other studies failing to show this association. In this study, we used a large statewide administrative dataset to investigate the relationship between neonatal phototherapy and cancer in the first year after birth.

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Maternal obesity, gestational diabetes, breastfeeding and childhood overweight at age 2 years

MedicalResearch.com Interview with:

Anny H. Xiang, PhD Kaiser Permanente Southern California Department of Research & Evaluation

Dr. Anny Xiang

Anny H. Xiang, PhD
Kaiser Permanente Southern California Department of Research & Evaluation

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Xiang: Previous studies have identified a link between maternal obesity, diabetes and/or excessive gestational weight gain and long-term obesity risk in children. Our study examined the interplay among all four factors associated with childhood obesity: pre-pregnancy obesity, gestational weight gain, gestational diabetes and breastfeeding. To our knowledge, the interplay among these factors and their independent contributions to childhood obesity with data from a large and multi-ethnic cohort under current standard clinical care had not been previously studied.

The study included 15,710 women who delivered babies at Kaiser Permanente medical facilities in Southern California in 2011. The key findings were:

  • A woman being obese (BMI of 30.0 or higher) prior to getting pregnant increased the odds of her child being overweight at age 2 by more than two-fold compared to women who had a normal pre-pregnancy weight (BMI between 18.5 and 25), after adjusting for weight gain during pregnancy, gestational diabetes and breastfeeding.
  • A woman being overweight (BMI between 25.0 and 29.9) prior to pregnancy was associated with 50 percent increased odds of her child being overweight at age 2.
  • Excessive weight gain during pregnancy was associated with 23 percent increased odds of a child being overweight at age 2 compared to women who had healthy weight gain during pregnancy after adjusting for pre-pregnancy weight, gestational diabetes and breastfeeding.
  • Breastfeeding for at least six months was associated with a 24 percent reduction for the odds of a child being overweight at age 2 regardless of a mother’s pre-pregnancy weight, gestational diabetes or excessive weight gain during pregnancy.
  • Gestational diabetes was not associated with the risk of a child being overweight at age 2. Women with gestational diabetes in this cohort were treated following standard clinical practice and had 40-49 percent lower rate of excessive weight gain during pregnancy and similar breastfeeding rates compared to women without gestational diabetes.

Excessive weight gain was defined according to Institute of Medicine guidelines, with normal-weight women gaining more than 35 pounds, overweight women gaining more than 25 pounds and obese women gaining more than 20 pounds during their pregnancy. Children were considered overweight at age 2 if their BMI was greater than the 85th percentile for their age and sex, based on growth charts from the Centers for Disease Control and Prevention.

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Aromatase Inhibitors Do Not Increase Risk of the Most Fatal Cardiovascular Events in Breast Cancer Patients

MedicalResearch.com Interview with:

Reina Haque, PhD, MPH Research scientist Department of Research & Evaluation Kaiser Permanente Southern California Pasadena Calif

Dr. Reina Haque

Reina Haque, PhD MPH
Research scientist
Kaiser Permanente Southern California Department of Research & Evaluation

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Haque: The study fills an important knowledge gap about the long-term association of aromatase inhibitors on cardiovascular disease risk in breast cancer survivors.

This was a retrospective cohort study that included a cohort of 13,273 postmenopausal breast cancer survivors who were diagnosed with breast cancer, either estrogen or progesterone receptor positive, from 1991 to 2010. The patients were followed through 2011, or a maximum of 21 years. The study participants were divided into four groups based on the drugs they received: 31.7 percent were treated only with tamoxifen; 28.6 percent only with aromatase inhibitors; 20.2 percent used both; and 19.4 percent did not use any of these drugs. These oral drugs are used to combat breast cancer recurrence, but may have long-term side effects on other organs.

The study determined that the risk of cardiac ischemia (which can lead to a heart attack) and stroke were not elevated in patients who only took aromatase inhibitors compared to those who only took tamoxifen. These results provide reassurance that aromatase inhibitors may not increase risk of the potentially fatal cardiovascular outcomes compared to tamoxifen.

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Hospital Stays Provide Opportunity to Vaccinate High Risk Patients

MedicalResearch.com Interview with:

Sara Y. Tartof, PhD, MPH Kaiser Permanente Southern California Department of Research & Evaluation

Dr. Sarah Tartoff

Sara Y. Tartof, PhD, MPH
Kaiser Permanente Southern California Department of Research & Evaluation

MedicalResearch.com: What is the background for this study? What are the main findings?

Dr. Tartof: The flu is a highly contagious respiratory infection that can cause serious complications, hospitalizations and, in some cases, even death. Some people, such as older adults, young children and people with certain health conditions, are at high risk for serious complications. In addition to recommending annual flu vaccination for people 6 months of age and older, the Centers for Disease Control and Prevention recommends that hospitalized patients who are eligible receive the flu vaccine before discharge.

Historically, inpatient rates of vaccination have been low. There has been concern among surgeons that vaccinating patients while they are in the hospital can contribute to increased risk of vaccine-related fever or muscle pain, which might be incorrectly attributed to surgical complications. However, there have been no data to support that concern. The objective of this study was to provide clinical evidence that would either substantiate or refute concerns about the safety of perioperative vaccination.

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Online Health Portals Linked To Better Adherence To Preventive Care

MedicalResearch.com Interview with:

Shayna L. Henry, PhD Postdoctoral Research Fellow Department of Research & Evaluation Kaiser Permanente Southern California

Dr. Shayna Henry

Shayna L. Henry, PhD
Postdoctoral Research Fellow
Department of Research & Evaluation
Kaiser Permanente Southern California

Medical Research: What is the background for this study? What are the main findings?

Dr. Henry: In this study, we analyzed the electronic health records of 838,638 Kaiser Permanente members in Southern California. We decided to conduct this study because Kaiser Permanente always strives to advance standards of excellence for care, and even with all the outreach resources available to health care providers and staff, gaps in preventive care still arise. It can be hard to get patients engaged in managing their preventive care, because there are so many tasks for them to keep track of – many of which don’t happen on a very regular basis. Online patient portals have been very useful at helping patients get more engaged in their care, but patients still have to make the first move, and put all the pieces together. Our tool, the Online Personal Action Plan (oPAP), puts our members’ health status and preventive and chronic care tasks in a single dashboard, and alerts them via email to their upcoming care needs, prompting them to log in, view their upcoming health care tasks such as annual vaccinations, tests and blood draws for chronic conditions, and routine cancer screenings, and make the necessary medical appointments to close those gaps in care. We wanted to better understand if having access to the oPAP tools was associated with a higher likelihood of taking care of those outstanding health care tasks in a timely manner.

We found that members who used oPAP were more likely to get a mammogram, Pap smear, receive colorectal cancer screenings, and more likely to complete HbA1c testing for diabetes within 90 days of their coming due compared to members who were not registered on our patient portal.   Continue reading

Postpartum Screening Important For Women With Hypertension During Pregnancy

MEDICALRESEARCH.COM INTERVIEW WITH:
KRISTI REYNOLDS, PHD, MPH 

MEDICALRESEARCH.COM INTERVIEW WITH: KRISTI REYNOLDS, PHD, MPH KAISER PERMANENTE RESEARCH RESEARCH & EVALUATION PASADENA, CA 91101

Dr. Kristi Reynolds

KAISER PERMANENTE RESEARCH
RESEARCH & EVALUATION
PASADENA, CA 91101 

Medical Research: What is the background for this study?

Dr. Reynolds: Hypertensive disorders during pregnancy are common, affecting up to 10 percent of all pregnant women, and include gestational hypertension, preeclampsia (which is a combination of high blood pressure and protein in the urine), and eclampsia, which includes seizures in women with severe preeclampsia. Research has shown that hypertensive disorders in pregnancy are associated with long-term cardiovascular disease risk, but little is known about the effect of these conditions in the early years after delivery.

As part of our study, we examined the electronic health records of 5,960 women who had prenatal care and delivered a baby at the Kaiser Permanente Southern California Bellflower Medical Center between 2005 and 2010. Women with high blood pressure before their pregnancy were excluded from the analysis.

Medical Research: What are the main findings?

Dr. Reynolds: We found that women who had a hypertensive disorder during pregnancy were 2.4 times more likely – and women with pre-eclampsia/eclampsia 2.5 times more likely – to develop pre-hypertension or hypertension in the year after delivery than those who maintained a normal blood pressure during their pregnancy, after controlling for differences between the groups.

In comparison to women with normal blood pressure during pregnancy, women with pregnancy-related hypertension tended to be slightly younger and overweight or obese before pregnancy. In addition, they were more likely to have had one or more children previously and to gain excess weight and develop gestational diabetes during their pregnancy.

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Stool Test May Get More People To Be Screened For Colon Cancer

Douglas A. Corley, MD, PhD Gastroenterologist and Research Scientist III Division of Research Kaiser Permanente Oakland, CA

Dr. Douglas Corley

MedicalResearch.com Interview with:
Douglas A. Corley, MD, PhD

Gastroenterologist and Research Scientist III
Division of Research
Kaiser Permanente
Oakland, CA 

Medical Research: What is the background for this study? What are the main findings?

Dr. Corley: Colorectal cancer is a leading cause of cancer death in the United States, so understanding how cancer screening tests for this cancer are used and if they are effective is extremely important.

There are two commonly used tests for colorectal cancer screening in the United States: colonoscopy and fecal immunochemical tests (also known as “FIT”). Colonoscopy requires a bowel preparation to clean you out and is invasive but, if normal, it is done infrequently (every ten years).

FIT is simple to do at home but, to be most effective, needs to be done every year. This has the advantage of potentially picking up cancers that grow between tests. There are few studies that have looked at how well FIT picks up cancers when used year after year. If a test picks up most cancers, it is said to be very “sensitive” for picking up cancer. Most studies only looked at 1 or 2 years of use for how well FITdetected cancers. It is possible that the first year of use may “clear out” most of the easily detectable cancers and that FIT might not work as well in subsequent years.

This very large study over several years at Kaisier Permanente, where we use both colonoscopy and FIT for colorectal cancer screening, looked at whether FIT worked as well at detecting cancer in years 3 and 4 as it did the first time someone used it.

We found that the sensitivity was highest in the first year, likely from clearing out cancers that were there for a while and easily detected, but that in subsequent years the sensitivity, though 5-10% lower, remained high. Also, most people who started with FIT continued doing it, suggesting that it is both feasible and effective for colorectal cancer screening.

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No Increase Risk of Breast Cancer Recurrence With Antidepressants While On Tamoxifen

Reina Haque, PhD, MPH Research scientist Department of Research & Evaluation Kaiser Permanente Southern California Pasadena Calif

Dr. Haque

MedicalResearch.com Interview with:
Reina Haque, PhD, MPH

Research scientist
Department of Research & Evaluation
Kaiser Permanente Southern California
Pasadena Calif

Medical Research: What is the background for this study? What are the main findings?

Dr. Haque: Tamoxifen is a commonly prescribed generic drug taken by women with breast cancer to reduce their chances of developing a recurrence. Tamoxifen is recommended for five years, but has notable side effects, including hot flashes, night sweats and depression. Since hormone replacement therapy is not recommended to alleviate these symptoms in breast-cancer survivors, antidepressants have been increasingly prescribed for relief. Almost half of the 2.4 million breast-cancer survivors in the U.S. take antidepressants.

However, previous studies have suggested that antidepressants reduce tamoxifen’s effectiveness in lowering subsequent breast-cancer risk. This study was conducted to determine whether taking tamoxifen and antidepressants (in particular, paroxetine) concomitantly is associated with an increased risk of recurrence or contralateral breast cancer.
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Breastfeeding May Lower Risk of Maternal Diabetes

MedicalResearch.com Interview with: Dr. Erica Gunderson

Dr. Gunderson

MedicalResearch.com Interview with:
Erica P. Gunderson, PhD, MPH, MS, RD

Senior Research Scientist, Division of Research, Cardiovascular and Metabolic Conditions Section
Kaiser Permanente Northern California
Oakland, CA 94612

Medical Research: What is the background for this study?

Dr. Gunderson: Gestational diabetes mellitus (GDM) is a disorder of glucose tolerance affecting 5-9 percent of all U.S. pregnancies (approximately 250,000 annually), with a 7-fold higher risk of progression to type 2 diabetes. Strategies during the postpartum period for prevention of diabetes focus on modification of lifestyle behaviors, including dietary intake and physical activity to promote weight loss.

Lactation is a modifiable postpartum behavior that improves glucose and lipid metabolism, and increases insulin sensitivity, with favorable metabolic effects that persist post-weaning. Despite these metabolic benefits, evidence that lactation prevents type 2 diabetes remains inconclusive, particularly among women with gestational diabetes mellitus (GDM). Among women with GDM, evidence that lactation prevents diabetes is based on only two studies with conflicting findings.

The Study of Women, Infant Feeding and Type 2 Diabetes after GDM Pregnancy, also known as the SWIFT Study, is the first to measure breastfeeding on a monthly basis during the first year after delivery and the first to enroll a statistically significant number of women with gestational diabetes, and to evaluate social, behavioral and prenatal risk factors that influence development of type 2 diabetes, as well as breastfeeding initiation and success.

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Majority of Gout Patients Do Not Achieve Target Uric Acid Level

Marsha A. Raebel, PharmD Senior Investigator Kaiser Permanente Colorado's Institute for Health Research

Dr. Raebel

MedicalResearch.com Interview with:
Marsha A. Raebel, PharmD
Senior Investigator
Kaiser Permanente Colorado’s Institute for Health Research

Medical Research: What is the background for this study? What are the main findings?

Dr. Raebel: Gout is an inflammatory arthritis that affects at least 7.5 million American adults. A hallmark of gout is high serum uric acid that can result in urate crystals being deposited in joints, causing pain and joint damage. The American College of Rheumatology (ACR) guidelines recommend lowering serum uric acid to target values in patients with gout to prevent urate crystal deposition in joints and to promote crystal dissolution. For most patients, serum uric acid levels should be reduced to < 6mg/dL and maintained below that level. Measuring serum uric acid is a necessary step when titrating urate-lowering medications using a treat to target approach, but little is known about either serum uric acid measurement practices or attainment of target serum uric acid levels outside of clinical trials. We set out to characterize uric acid measurement and target serum uric acid attainment in patients with gout in the usual ambulatory care settings of the Kaiser Permanente integrated health system in the United States.

We identified 72,803 patients newly-diagnosed with gout in three Kaiser Permanente regions; 61% had at least one serum uric acid measurement within the baseline year prior to their gout diagnosis. Over each 12 month interval after the gout diagnosis, fewer patients had a serum uric acid measured. For example, serum uric acid measurement decreased to 40% of the patients the first year after the gout diagnosis, and to 26% of patients the second year after the gout diagnosis. While median serum uric acid levels across all patients decreased from 8.0 to 6.6 mg/dL over the entire 12 years of follow-up, almost 60% of patients never achieved a serum uric acid level less than 6 mg/dL. Achievement of this target serum uric acid level was more frequent in those who had a lower serum uric acid at baseline. Less than 12% of patients achieved all follow-up serum uric acid levels in the target range.

Medical Research: What should clinicians and patients take away from your report?

Dr. Raebel: Clinicians should be aware that, although most patients had at least one serum uric acid measured at some time, regular serum uric acid assessment was infrequent. Infrequent serum uric acid assessment impedes optimal use and monitoring of urate-lowering therapy. More than half of patients did not achieve any serum uric acid value within the target range of less than 6mg/dL. Given that the majority of patients with new-onset gout never reach the target serum uric acid level, more frequent serum uric acid measurement is urged.

Specifically, patients should adhere to having serum uric acid monitored as recommended by their physician and should request that their physician periodically order laboratory serum uric acid testing for them at frequencies based on treatment guidelines. To assist in reaching serum uric acid target levels, patients should take their urate-lowering medication as prescribed by their doctor. Furthermore, they should not stop their urate-lowering therapy without having been so advised by their doctor.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Raebel: We recommend developing interventions that support physicians and patients with gout in monitoring serum uric acid and treating to target serum uric acid levels. For example, best practice alerts could be developed and implemented in electronic health records that prompt physicians to order serum uric acid laboratory testing when more than a year has passed between measurements for any patient with gout or more frequently for patients who are not in the target range.

Citation:

Abstract presented at the 2015 ACR meeting November 2015

Treating to Target in Gout: The Epidemiology of Serum Urate Measurement Among Patients with Incident Gout in Usual Care Settings in the United States

Marsha A. Raebel, PharmD (2015). Majority of Gout Patients Do Not Achieve Target Uric Acid Level 

Pediatric Obesity Slowly Declining

MedicalResearch.com Interview with:

Dr-Corinna-Koebnick Corinna Koebnick, PhD
Research scientist with Research & Evaluation
Kaiser Permanente Southern California

MedicalResearch: Please describe your study, what you were looking for, and why. 

Dr. Koebnick: This study is based on the Kaiser Permanente Southern California Children’s Health Study, which includes all children and adolescents 2–19 years of age in Southern California who are actively enrolled in a large, integrated, managed health care system. We examined the body weight from electronic health records of more than 1.3 million children and adolescents 2-19 years of age from 2008 to 2013.

The objective of this study was to investigate recent trends in pediatric obesity in Southern California between 2008 and 2013. Several recent studies have investigated national trends in childhood obesity in the United States and indicated that childhood obesity rates may have reached a plateau, but are not declining. Ours is one of the few studies that is large enough to be able to detect small changes in the prevalence of obesity in time periods of less than 10 years.

MedicalResearch: What are the findings of this study? 

Dr. Koebnick: Our study provides strong indication that the prevalence of overweight and obesity between 2008 and 2013 has not only plateaued, but also is slowly declining. While the decline in overweight and obesity was less pronounced in girls, adolescents, some minority groups and youth living in low income and low education areas, the decline was remarkably stable across all groups and significant even in minority youth and youth of lower socioeconomic status.

We found the prevalence of overweight and obesity decreased overall by 2.2 percent and 1.6 percent, respectively. This change corresponds to a relative decline of 6.1 percent in overweight youth and 8.4 percent in obese youth. Although a decline was seen across all groups, the decrease was not as strong in adolescents aged 12-19 years, in girls compared to boys, and Hispanic and black children compared to non-Hispanic whites.

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Both Gastric Banding and Bypass Surgery Reduce Medical Costs

MedicalResearch.com Interview with:
Kristina H. Lewis, MD, MPH, SM
Kaiser Permanente Georgia, Center for Clinical and Outcomes Research, Atlanta
Department of Population Medicine
Harvard Medical School/Harvard Pilgrim Health Care Institute, Boston, Massachusetts

Medical Research: What is the background for this study?

Dr. Lewis: The prevalence of severe obesity (BMI ≥40 kg/m2) in the U.S. is rising. This is concerning, because patients with severe obesity tend to be sicker and have higher healthcare costs.  Bariatric surgery produces substantial weight loss and remission of a number of obesity-related comorbidities, but there have been very few studies directly comparing current procedure types. This leaves patients, providers and insurers with little information to help them decide about the pros and cons of different surgeries.

We wanted to compare outcomes after two of the most common bariatric surgeries in the US – laparoscopic adjustable gastric banding (band) and laparoscopic roux-en-y gastric bypass (bypass). To do this, we examined commercial claims data from almost 10,000 U.S. band and bypass patients who were very similar with respect to age, gender, and medical conditions. We looked at what happened to these patients from one year before their surgeries through 3 years after surgery. We compared changes in medical costs and use of healthcare services before and after surgery.

Medical Research: What are the main findings?

Dr. Lewis: When performed laparoscopically, both gastric bypass and adjustable gastric banding appear to result in lower total medical costs after surgery.  Bypass patients see a greater immediate drop in prescription drug costs than band patients – this is not surprising given that we know that this surgery is more likely to induce weight loss and diabetes remission. Unfortunately, bypass patients also have an initial increase in emergency department visits after surgery that is not present for banding patients.

When we compared total annual medical costs between band and bypass, we found no difference between procedures in the first 2 years after surgery. But, by year 3, bypass patients’ total annual medical costs are about 16% lower than those for band patients.

Medical Research: What should clinicians and patients take away from your report?

Dr. Lewis: Patients and clinicians considering one of these procedures should see these findings as good news. On balance, it looks like, for a group of very sick patients whose annual medical costs are trending upwards before surgery, these procedures result in overall lower levels of healthcare use after they are performed. Deciding between the two procedures, or opting for even newer procedure types, such as sleeve gastrectomy, would require a conversation between patients and their providers about their specific medical needs and their personal health goals.

Medical Research: What recommendations do you have for future research as a result of this study?

Dr. Lewis: Studies are needed that examine the newer “vertical sleeve gastrectomy” procedure in a similar fashion. That procedure has become very popular in the U.S. recently but very little is known about longer-term outcomes after it.  Also – formal cost effectiveness studies that weigh the costs of the procedures against any potential benefits to patients would be important to conduct.

Citation:

Lewis KH, Zhang F, Arterburn DE, Ross-Degnan D, Gillman MW, Wharam J. Comparing Medical Costs and Use After Laparoscopic Adjustable Gastric Banding and Roux-en-Y Gastric Bypass. JAMA Surg. Published online June 03, 2015. doi:10.1001/jamasurg.2015.1081.

 

Kristina H. Lewis, MD, MPH, SM, Kaiser Permanente Georgia, Center for Clinical and Outcomes Research, Atlanta, Department of Population Medicine,  Harvard Medical School/Harvard Pilgrim Health Care Institute, Boston, Massachusetts (2015). Both Gastric Banding and Bypass Surgery Reduce Medical Costs 

Lump Sum Payments To Long-term Care Hospitals May Have Created Incentive To Discharge Patients

Yan S. Kim, MD PhD Delivery Science Fellow Division of Research Kaiser Permanente Northern California Oakland, CA 94612MedicalResearch.com Interview with:
Yan S. Kim, MD PhD
Delivery Science Fellow Division of Research
Kaiser Permanente Northern California
Oakland, CA 94612

Medical Research: What is the background for this study? What are the main findings?

Dr. Kim: Long-term care hospitals first emerged in the 1980s as an alternative to lengthy acute-care hospital stays for patients with complex medical problems who need prolonged hospital-level care.  In 2002, Medicare changed its payment method for these facilities from cost-based to a lump sum per admission based on the diagnosis.  Under this system, which is still in place, Medicare pays these hospitals a higher rate for patients who stay a minimum number of days based on the patient’s condition.  Shorter stays are paid much less and longer stays do not necessary generate higher reimbursements.

Using Medicare data, we analyzed a national sample of patients who required prolonged mechanical ventilation – the most common, and among the most costly, conditions for patients in long-term care hospitals – to examine whether this payment policy has created incentives to base discharge decisions on payments.  We found that in the years after the policy’s implementation there was a substantial spike in the percentage of discharges on and immediately after the minimum-stay threshold was met, while very few patients were discharged before the threshold. By contrast, prior to 2002, discharges were evenly distributed around the day that later became the short-stay threshold.  These findings confirm that the current payment policy has created unintended incentives for long-term care hospitals to base the timing of patient discharges on payments and highlight how responsive these hospitals are to payment incentives.

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Pain From Sciatica Not Helped By Oral Steroids

Harley Goldberg, DO Physical Medicine and Rehabilitation Kaiser PermanenteMedicalResearch.com Interview with:
Harley Goldberg, DO
Physical Medicine and Rehabilitation
Kaiser Permanente

Medical Research: What is the background for this study? What are the main findings?

Dr. Goldberg: This is the first large-scale randomized, double-blind, placebo-controlled clinical trial of oral steroids for acute radiculopathy, commonly called sciatica, associated with a herniated lumbar disk.

Lumbar radiculopathy (or pain down the leg in a lumbar nerve root distribution) is a common source of pain and disability for many adults. It is thought that inflammation from a disk herniation is responsible for many of the symptoms, so giving a powerful anti-inflammatory, such as steroid medication, might help relieve sciatica symptoms quickly. Prior research has shown that lumbar diskectomy does not affect the one year outcome for most patients, and epidural steroid injections do not have strong support by clinical trials. If the use of epidural steroids injections is based on application of steroid anti-inflammatory to the affected nerve root(s), perhaps an oral steroid can have affect. Although oral steroids are used by many physicians and have been included in some clinical guidelines, no large-scale clinical trials of oral steroids for sciatica have been conducted before.

Our study found that among patients with acute radiculopathy associated with a herniated lumbar disk, a short course of oral steroids resulted in only modest improvement in function and no significant improvement in pain.
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Anticoagulation Bridge Therapy May Be Unnecessary For Low Risk Venous Thromboembolism Patients


MedicalResearch.com Interview with:
Nathan Clark, PharmD
Clinical pharmacy supervisor, anticoagulation and anemia management services and
Thomas Delate, PhD
Clinical research scientist
Kaiser Permanente Colorado

MedicalResearch: What is the background for this study? What are the main findings?

Response: Patients with a history of blood clots are commonly prescribed warfarin, an anticoagulant, to decrease the body’s ability to form additional clots. Clinicians typically stop the use of warfarin in patients to reduce the risk of serious bleeding when invasive procedures, such as colonoscopy or orthopedic surgery are scheduled. However, when warfarin interruptions occur, patients are exposed to an increased risk of blood clots three to five days before and five or more days after invasive procedures. Bridge therapy with another, faster acting anticoagulant is often initiated in an attempt to reduce the patients’ risk for developing blood clots during that gap.

Bridging has been a part of standard therapy for venous thromboembolism (VTE) patients undergoing invasive procedures for many years. But only limited data outlining the rates of bleeding and VTE recurrence were available to help clinicians analyze the risks and benefits of bridge therapy.

We examined the electronic medical records of 1,178 patients with VTE who underwent 1,812 invasive diagnostic or surgical procedures between January 2006 and March 2012 that required the interruption of warfarin therapy. Study patients were categorized into three groups based on their annual risk of VTE recurrence without anticoagulant therapy. Within those groups, a total of 555 patients – 28.7 percent of low-risk, 33.6 percent of moderate-risk and 63.2 percent of high-risk patients – received bridging anticoagulant therapy. The 1,257 patients who did not receive bridge therapy interrupted their warfarin use and received no other anticoagulants during the perioperative period. The use of bridge therapy resulted in a 17-fold higher risk of bleeding without a significant difference in the rate of blood clot formation compared to patients who didn’t receive bridge therapy. In addition, there were no significant differences in the rates of blood clot occurrence or death between the bridged and non-bridged patient groups. Continue reading

Study Finds No Increased Heart Attack Risk in HIV Patients

Dr. Daniel Klein, MD Kaiser Permanente Northern California San Leandro Medical Center San Leandro, CA MedicalResearch.com Interview with:
Dr. Daniel Klein, MD
Kaiser Permanente Northern California
San Leandro Medical Center
San Leandro, CA

Medical Research: What is the background for this study?

Dr. Klein: The prognosis for individuals living with HIV infection has dramatically improved with the availability of potent, well-tolerated and convenient antiretroviral therapies. HIV infection can now be viewed as a chronic, manageable condition with the life expectancy of successfully treated patients approaching that of uninfected individuals. As the focus of long-term HIV care has shifted from the managing opportunistic infections and cancers that were the hallmark of the early years of the HIV epidemic, increased attention is being directed at the consequences of treatment, immunodeficiency and chronic inflammation. One such complication is a reported increased risk of coronary artery disease. A recent report from Kaiser Permanente researchers in California offers some good news on this topic. For more than a decade, these investigators, led by Dr Daniel Klein, Chief of Infectious Diseases at Kaiser Hospital in San Leandro, CA, have been comparing rates of hospitalizations for Acute Myocardial infarctions and other forms of coronary artery disease between a group of HIV infected individuals and a large comparison group of uninfected health plan members. In the early years of their study, they noted an increased risk of coronary disease among HIV infected individuals. However in a recently published report, researchers found that there was no longer an excess risk.

Kaiser Permanente is a large, not-for-profit health care provider based in California. For more than 20 years, researchers have been collecting information on their HIV infected members. By matching the HIV patients to other uninfected health plan members who were of comparable age, sex and race, these investigators have been comparing the rates of a number of medical problems between the groups. Their first report on an excess risk of coronary artery disease was published in 2002. The original observation of an excess risk for heart disease was attributed to higher rates of certain conventional risk factors among the HIV group such as smoking as well as exposure to protease inhibitor class drugs.

Medical Research: What was the findings of this study?

Dr. Klein: By comparing the relative rates over time in the most recent study interval, there was no longer an increased risk for a Myocardial infarction among the HIV group as compared to the uninfected group when matched by age, sex and presence.

Medical Research: To what do the authors ascribe this recent finding?

Dr. Klein: A number of factors may have contributed to the results including increased attention to conventional risk factor reduction with greater use of lipid lowering therapies and smoking cessation programs. Also, newer HIV medications may have less association with premature coronary artery disease. In keeping with national guidelines, Kaiser patients are initiating HIV treatment at higher CD4 cell counts and of those on therapy, more than 85 percent have undetectable viral loads. In an earlier report, these researchers observed that patients who maintained CD4 cell counts over 500 had no excess risk of an MI confirming the role of immunodeficiency in premature coronary artery disease among HIV individuals.

Medical Research: What are the main take away messages from this study?

Dr. Klein: For patients, knowing whether you are HIV positive is key to entering care and preserving your immune function. Also if you are a smoker, quitting is the best thing you can do for your own health in conjunction with regular exercise and a healthy diet.  For providers, aggressive conventional risk factor reduction efforts are clearly warranted, coupled with early initiation of antiretroviral treatments to preserve immune function, can translate into reduced heart disease in your patients.

What are the limitations of this study?

Dr. Klein: The majority of our HIV positive members were men so more information about outcomes among HIV infected women is needed. Also, the findings of no increased risk for MIs was over a two year period and further long-term follow up is warranted to ensure that this finding is sustained.

Citation:

Declining Relative Risk for Myocardial Infarction Among HIV-Positive Compared with HIV-Negative Individuals with Access to Care

Clin Infect Dis. first published online January 16, 2015 doi:10.1093/cid/civ014
Daniel B. Klein, Wendy A. Leyden, Lanfang Xu, Chun R. Chao, Michael A. Horberg, William J. Towner, Leo B. Hurley, Julia L. Marcus, Charles P. Quesenberry, Jr., and Michael J. Silverberg

 

 

 

Adverse Reactions to Cephalosporin Antibiotics Reviewed

Eric Macy, MS, MS Allergy & Immunology Kaiser Permanente Medical Group-AllergyMedicalResearch.com Interview with:
Eric Macy, MS, MS
Allergy & Immunology
Kaiser Permanente Medical Group-Allergy

 

Medical Research: What are the main findings of the study?

Dr. Macy:

  • Cephalosporins are currently widely and relatively safely used in individuals with a history of a penicillin “allergy” in their medical record.
  • Cephalosporin associated anaphylaxis is very rare, even in individuals with a history of penicillin “allergy”.
  • Cephalosporin associated serious cutaneous adverse reactions are extremely rare.
  • Cephalosporin associated Clostridium difficile and serious nephropathy are relatively common.
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Meningococcal Vaccine Menveo Response in Adolescents

Roger Paul Baxter, MD Co-Director Kaiser Permanente Vaccine Study Center Oakland, CA 94612.MedicalResearch.com Interview with:
Roger Paul Baxter, MD
Co-Director Kaiser Permanente Vaccine Study Center
Oakland, CA 94612.

MedicalResearch.com What are the main findings of the study?

Dr. Baxter:  Menveo, the currently licensed CRM-conjugate meningococcal vaccine, showed an excellent booster response in adolescents, regardless of which conjugate vaccine they had received previously.  Also, although titers from the priming dose waned, at 3 years there were still protective antibodies in the majority of immunized individuals.  The other US-licensed meningococcal conjugate vaccine, Menactra, uses a different protein conjugate.
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