MedicalResearch.com - Medical Research Week in Review

MedicalResearch.com
Exclusive Interviews with Medical Research and
Health Care Researchers from Major and Specialty Medical
Research Journals and Meetings
Editor: Marie Benz, MD
info@medicalresearch.com
April 27 2014
For Informational Purposes Only: Not for Specific Medical Advice.

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Obstructive Sleep Apnea Associated with Hypertension in Perimenopausal Women
MedicalResearch.com Interview with: Rodrigo Pinto Pedrosa, MD, PhD
Sleep and Heart Laboratory, Pronto Socorro Cardiológico de Pernambuco Pernambuclo, Brazil
• MedicalResearch.com: What are the main findings of the study?
• Dr. Pedrosa: Perimenopause is associated with increased cardiovascular risk. This study
evaluated the association between obstructive sleep apnea (OSA) and arterial stiffness and
hypertension in perimenopausal women. OSA (apnea-hypopnea index: ≥5 events/hour) and
moderate/severe OSA (apnea-hypopnea index: ≥15 events/h) were diagnosed in 111 (40.1%)
and 31 (11.1%) of women, respectively. Women with moderate/severe obstructive sleep
apnea had a higher prevalence of hypertension, were prescribed more medications for
hypertension, had higher awake blood pressure, nocturnal blood pressure, diastolic blood
pressure, as well as higher arterial stiffness (pulse wave velocity: 11.5 [10.1 to 12.3] vs 9.5
[8.6 to 10.8] m/s, p<0.001) than women without obstructive sleep apnea, respectively.
Oxygen desaturation index during the night was independently associated with 24h arterial
blood pressure and with arterial stiffness.
MedicalResearch.com: Were any of the findings unexpected?
• Dr. Pedrosa: No. Previously, we had more evidence of the association between arterial
stiffness and obstructive sleep apnea among men. Now, our results extends this knowledge
to the perimenomausal population.
Read the rest of the interview on MedicalResearch.com

Obstructive Sleep Apnea Associated with Hypertension in Perimenopausal Women
MedicalResearch.com Interview with: Rodrigo Pinto Pedrosa, MD, PhD
Sleep and Heart Laboratory, Pronto Socorro Cardiológico de Pernambuco Pernambuclo, Brazil
• MedicalResearch.com: What should clinicians and patients take away from your report?
• Dr. Pedrosa: Obstructive sleep apnea is common, underdiagnosed and
independently associated with high blood pressure and increased arterial stiffness in the
perimenopause.
• MedicalResearch.com: What recommendations do you have for future research as a result
of this study?
• Dr. Pedrosa: Future studies must address the role of OSA treatment in this population to
evaluate blood pressure and arterial stiffness reductions.
• Citation:
• Obstructive sleep apnea is common and independently associated with hypertension and
increased arterial stiffness in consecutive perimenopausal women
Pedrosa RP, Barros IL, Drager LF, et al.
• Published online April 17, 2014.
doi:10.1378/chest.14-0097.

Prostate Cancer: Cost Savings from Active Surveillance
MedicalResearch.com Interview with: Alice Dragomir, MSc, PhD
Assistant Professor, Urology/Surgery, McGill University
Scientist, RI-MUHC
• Authors’ response: Our study demonstrates that for eligible patients, active surveillance
could offer not only the known clinical advantages from the patient’s perspective, but also
economic benefits from the health care system’s perspective. At the national level, the cost
savings of an annual cohort of incident prostate cancers managed with active surveillance
over a first year and 5 years of follow-up could be substantial. These are estimated at $96
million.
• MedicalResearch.com: Were any of the findings unexpected?
• Authors’ response: The difference between the cost per patient on active surveillance and
cost per patient receiving immediate treatment is impressive. Over the first year and 5 years
of follow-up these costs are estimated at: $6200 for active surveillance and $13 735 for
immediate treatment, corresponding to a relative reduction of 54.9% for active surveillance.

Prostate Cancer: Cost Savings from Active Surveillance
MedicalResearch.com Interview with: Alice Dragomir, MSc, PhD
Assistant Professor, Urology/Surgery, McGill University
Scientist, RI-MUHC
• Authors’ response: When no additional clinical benefits are expected with an early initiation
of an active treatment, clinicians can be reassured that there is no economic reason for it.
Our results confirm that delayed treatment is associated with additional costs in patients
requiring treatment after active surveillance, but this cost is minimal.
of this study?
• Authors’ response: Our study was based on a modeling approach, with initial and follow-up
costs of treatments and active surveillance derived from hospital protocols. Future research
on observational studies could be performed to account for actual healthcare resources
used, as well as for adverse events and complications related to treatments.
Citation:
Active surveillance for low-risk prostate cancer
compared with immediate treatment: a Canadian cost comparison
Alice Dragomir PhD, Fabio L. Cury MD, Armen G. Aprikian MD
CMAJ Open April 24, 2014

Suicide and Self-Harm: Genetic and Environmental Influences Overlap
MedicalResearch.com Interview Invitation
Karin J. H. Verweij, PhD
Department of Developmental Psychology and EMGO Institute for Health and Care Research, VU University
Amsterdam, the Netherlands
• Dr. Verweij: We performed a twin study using over 10,000 adult Australian twins to determine the relative importance of
genetic and environmental influences on individual differences in non-suicidal self-injury (NSSI) and suicidal ideation and
their covariation.
• We found that individuals that report self-harm are approximately eight times more likely to also report suicidal ideation.
Results from the bivariate genetic model indicated that the substantial correlation between non-suicidal self-injury and
suicidal ideation (r=0.49 for males and 0.61 for females) is largely explained by overlapping genetic factors: 62% and 76% for
males and females, respectively. Overlapping residual influences, including nonshared environmental influences and
measurement error, also explain part of the covariance between the two traits. These findings suggest that the two
behaviors share similar biological underpinnings.
• Dr. Verweij: This study showed that there is a high comorbidity between non-suicidal self-injury and suicidal ideation, and
this comorbidity is for a substantial part due to overlapping genetic influences. An important implication for clinicians and
patients is that individuals that engage in non-suicidal self-injury are at risk for also developing suicidal behaviors. Early
intervention targeting non-suicidal self-injury should therefore also focus on preventing suicidal behaviors.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
• Dr. Verweij: Future research should further investigate which genetic and environmental influences underlie the
vulnerability in NSSI and suicidal ideation. Studies may focus on both the overlapping genetic and environmental influences
as well as on the influences that are unique for each behavior. There are currently not many studies that directly
compare non-suicidal self-injury and suicidal behaviors; identification of the overlapping and unique risk factors will be
valuable for developing effective prevention and intervention strategies.
• Citation:
Overlapping Genetic and Environmental Influences on Nonsuicidal Self-injury and Suicidal Ideation: Different Outcomes,
Same Etiology?
• Dominique F. Maciejewski, BSc; Hanneke E. Creemers, PhD; Michael T. Lynskey, PhD; Pamela A. F. Madden, PhD; Andrew
C. Heath, PhD; Dixie J. Statham, DPsych; Nicholas G. Martin, PhD; Karin J. H. Verweij, PhD
• JAMA Psychiatry. Published online April 23, 2014. doi:10.1001/jamapsychiatry.2014.89
•

Homeless Men: Association with High Rate of Prior Brain Injury
MedicalResearch.com Interview with:
Jane Topolovec-Vranic, PhD
Clinical Researcher, Trauma and Neurosurgery Program
Assistant Professor, Department of Occupational Science and Occupational Therapy, University of Toronto
• MedicalResearch.com What are the main findings of the study?
• Answer: In our study we found that almost half of the men interviewed in a homeless shelter
in Toronto had experienced a traumatic brain injury in their past, and that most of them had
experienced their first brain injury prior to becoming homeless, usually in the early teenage
years.
MedicalResearch.com Were any of the findings unexpected?
• Answer: An unexpected finding was that although many of the men had experienced at least
one of their brain injuries as a result of an assault, high numbers of them indicated that they
had experienced them as a result of sports and recreation, motor vehicle collisions, and or
falls.

Homeless Men: Association with High Rate of Prior Brain Injury
Jane Topolovec-Vranic, PhD
Clinical Researcher, Trauma and Neurosurgery Program
Assistant Professor, Department of Occupational Science and Occupational Therapy, University of Toronto
• MedicalResearch.com What should clinicians and patients take away from your report?
• Answer: Given that many of the injuries occurred in youth, by events that could happen to
any of us, this strongly supports the need for injury prevention strategies and potential
longer-term monitoring of youth after brain injuries. Clinicians and frontline workers should
also keep in mind that the behaviors of these individuals may be influenced by a brain injury
from their past.
• MedicalResearch.com What recommendations do you have for future research as a result
of this study?
• Answer: Future research could assess the comfort and ability of workers with individuals who
are homeless to assess for and manage symptoms of traumatic brain injury. Also, the effect of
implementing strategies to reduce the symptoms related to past traumatic brain injury, or to
prevent the occurrence of new injuries should be evaluated.
• Citation:
• Traumatic brain injury among men in an urban homeless shelter: observational study of rates
and mechanisms of injury
Jane Topolovec-Vranic PhD, Naomi Ennis BA(Hons), Mackenzie Howatt BSc(Hons) and
colleagues
CMAJ Open April 25, 2014

Stroke: Prediction Tool Separates Risk For Ischemic vs Hemorrhagic Event
M. Arfan Ikram, MD, PhD
Assistant professor in Neuroepidemiology Erasmus Medical Center
Rotterdam, the Netherlands
• MedicalResearch.com: What are the main findings of this study?
• Dr. Ikram: We show that the risk of stroke might be increased due to an increased risk of
ischemic stroke or increased risk of hemorrhagic stroke. Because these subtypes of stroke
require different -often opposite- clinical management, currently available prediction rules
for any stroke are insufficient. We propose a novel prediction rule that provides separate
risks for ischemic stroke and hemorrhagic stroke.
• MedicalResearch.com: Were any of the findings surprising?
• Dr. Ikram: We show that an increased risk of ischemic stroke stroke does not parallel an
increased risk of hemorrhagic stroke. In other words, there is a subgroup of persons that
specifically has an increased risk of hemorrhagic stroke and not ischemic stroke, and vice
versa. These different subgroups may therefore require different clinical management.
Ischemic strokes occur due to insufficient blood supply to parts of the brain; these strokes
require opening the obstructed artery to re-establish blood flow. In contrast, hemorrhagic
strokes occur due to leakage of blood through blood vessels into the brain; these strokes
require stopping the bleeding.

Stroke: Prediction Tool Separates Risk For Ischemic vs Hemorrhagic Event
M. Arfan Ikram, MD, PhD
Assistant professor in Neuroepidemiology Erasmus Medical Center
Rotterdam, the Netherlands
• MedicalResearch.com: What should patients and clinicians take away from this report?
• Dr. Ikram: An increased risk of stroke can be either due to ischemic stroke or hemorrhagic
stroke, and these two risks should be assessed differently.
• MedicalResearch.com: What further research do you recommend as a result of this study?
• Dr. Ikram: Future studies can focus on several points.
• First, they can investigate whether this prediction rule can be further refined by using
additional clinical information, e.g. APOE-genotype, medication use etc.
• Second, studies should investigate to what extent the clinical management between the
subgroups should indeed differ. Finally, a further refinement of subgroups can be made, for
instance studying subtypes of ischemic stroke (small vessel, large vessel, cardioembolic) or
hemorrhagic stroke (lobar versus deep).
• Citation:
Separate prediction of intracerebral hemorrhage and ischemic stroke
Bart S. Ferket, Bob J.H. van Kempen, Renske G. Wieberdink, Ewout W. Steyerberg, Peter J.
Koudstaal, Albert Hofman, Eyal Shahar, Rebecca F. Gottesman, Wayne Rosamond, Jorge R.
Kizer, Richard A. Kronmal, Bruce M. Psaty, W.T. Longstreth, Jr, Thomas Mosley, Aaron R.
Folsom, M.G. Myriam Hunink, and M. Arfan Ikram
Neurology 10.1212/WNL.0000000000000427; published ahead of print April 23, 2014

Diuretic Acetazolamide Improved Visual Outcomes in Intracranial Hypertension
MedicalResearch.com Interview with: Michael Wall, MD
Department of Neurology,
University of Iowa Hospitals and Clinics, 200 Hawkins D
Iowa City, IA 52242-1091
• Dr. Wall: We studied patients with idiopathic intracranial hypertension (formerly called
pseudotumor cerebri) with mild visual loss. We found that subjects taking acetazolamide, a
type of diuretic, along with a low sodium weight loss program had significantly better visual
outcomes than those taking placebo along with the diet.
• Dr. Wall:
• 1. Acetazolamide improved vision and symptoms independent of the amount of weight loss.
• 2. Acetazolamide prevented severe visual field worsening (treatment failures).
• 3. Patients with higher grades of optic disc swelling regained much more vision than those
with lower grades.
• 4. Acetazolamide, in spite of having side effects, improves patients’ quality of life scores.

Diuretic Acetazolamide Improved Visual Outcomes in Intracranial Hypertension
MedicalResearch.com Interview with: Michael Wall, MD
Department of Neurology,
University of Iowa Hospitals and Clinics, 200 Hawkins D
Iowa City, IA 52242-1091
• Dr. Wall: The main message is that there for the first time, data from a properly controlled
clinical trial to guide therapy in idiopathic intracranial hypertension patients. In IIH patients
with mild visual loss, acetazolamide when combined with a low sodium weight reduction
program improves vision, reduces optic disc swelling and improves quality of life. The
medication was well tolerated with no known permanent untoward side effects.
of this study?
• Dr. Wall: Future research should be aimed at finding the cause of idiopathic intracranial
hypertension. Secondly, we need another clinical trial to develop protocols for treating more
severe visual loss.
• Citation:
• The NORDIC Idiopathic Intracranial Hypertension Study Group Writing Committee. Effect of
Acetazolamide on Visual Function in Patients With Idiopathic Intracranial Hypertension and
Mild Visual Loss: The Idiopathic Intracranial Hypertension Treatment Trial. JAMA.
2014;311(16):1641-1651. doi:10.1001/jama.2014.3312.

Predicting Alzheimer’s Disease in Patients With Mild Cognitive Impairment
Ziad Nasreddine MD FRCP© Professeur adjoint
Université de Sherbrooke et McGill University
Neuro Rive-Sud/CEDRA: Centre Diagnostique et Recherche sur la Maladie d’Alzheimer Québec, Canada
• MedicalResearch.com: What are the main findings of this study?
• Dr. Nasreddine: The Montreal Cognitive Assessment (MoCA) total score (MoCA-TS) and Memory Index
Score (MoCA-MIS) are useful in predicting conversion to Alzheimer’s disease (AD) in individuals with mild
cognitive impairment (MCI). Identifying individuals with MCI at high of conversion to Alzheimer’s disease is
important clinically and for selecting appropriate subjects for therapeutic trials.
MedicalResearch.com: What should clinicians and patients take away from your report?
• Dr. Nasreddine: The MoCA and it’s Memory index sub-score is a short and simple test that may be very
useful in determining which mild cognitive impairment patients would require close follow-up and
attention because of their risk of conversion to dementia.
• MedicalResearch.com: What recommendations do you have for future research as a result of this study?
• Dr. Nasreddine: The MoCA usefulness to predict MCI to AD conversion should be compared to Alzheimer’s
disease Biomarkers, and possibly associated with them, to improve biomarkers‘ performance, or help
determine when biomarkers should be used in mild cognitive impairment subjects in order to improve
sensitivity and specificity of these expensive measures.
• Citation:
Montreal Cognitive Assessment Memory Index Score (MoCA-MIS) as a Predictor of Conversion from Mild
Cognitive Impairment to Alzheimer’s Disease
J Am Geriatr Soc 62:679–684, 2014.
• Parunyou Julayanont MD,
• Mélanie Brousseau SWT,
• Howard Chertkow MD,
• Natalie Phillips PhD3,6 and
• Ziad S. Nasreddine MD

Stroke: More Patients Getting Faster Treatment, Fewer Complications
Dr. Gregg C. Fonarow MD
Director, Ahmanson-UCLA Cardiomyopathy Center
Professor, Department of Medicine Associate Chief, Cardiology
• Dr. Fonarow: This study examined data from hospitals that have adopted the American Heart
Association/ American Stroke Association’s national quality initiative, Target: Stroke, which aims to
increase the number of stroke patients treated with clot-busting drugs for ischemic stroke within 60
minutes or less after hospital arrival. Initiated nationwide in 2010, Target: Stroke provided 10 key
strategies as well as tools to facilitate timely tPA administration, as well as additional approaches to
improve stroke care and outcome.
• Data from 71,169 tPA-treated stroke patients at 1,030 hospitals participating in Target: Stroke were
analyzed to compared the time to treatment and incidence of complications before
implementation, from 2003 to 2009, to the post-implementation years, from 2010 to 2013.
• This study found that the percentage of patients treated within the recommended timeframe
increased from less than one-third before Target: Stroke to more than half afterwards. The Target:
Stroke program goal of 50 percent or more of patients having door-to-needle times within 60
minutes was successfully achieved. In addition, the average time to treatment dropped by 15
minutes, from 74 to 59 minutes.
• Faster treatment was associated with lower rates of complications, including death. Before Target:
Stroke, 9.9% of stroke patients died in the hospital, compared to 8.3% of patients treated after the
initiative started, a difference which was statistically significant. In addition, patients treated by
Target: Stroke strategies were less likely to develop the complication of symptomatic intracranial
hemorrhage.

• Dr. Fonarow: While there have been concerns that attempting to achieve shorter DTN times
may lead to rushed assessments, inappropriate patient selection, dosing errors, and greater
likelihood of complications, our findings suggest that more rapid reperfusion therapy in acute
ischemic stroke is feasible and, importantly, can be achieved not only without increasing rates
of symptomatic intracranial hemorrhage, but with actual reductions in complications and
improvements in overall tPA treatment rates.
• While the clinical outcome improvements observed in this study and their magnitude are
consistent with those expected with more timely tPA treatment based prior studies in acute
ischemic stroke, these findings stand in contradistinction to an analysis involving 515
hospitals and 96,738 admissions in which reductions in door-to-balloon times in ST-segment
elevation myocardial infarction were not accompanied by any changes in short-term
mortality rates. This difference potentially reflects greater sensitivity of the brain versus the
heart to functionally relevant ischemia progression over time spans of several minutes.

• Dr. Fonarow: The Target: Stroke quality improvement initiative was highly successful in
improve stroke care and clinical outcomes at the national level. These findings also further
reinforce the importance and clinical benefits of faster administration of intravenous tPA. By
showing that the timeliness of tPA administration can be improved at the national level,
these findings also support further expansion of the Target: Stroke initiative.

of this study?
• Dr. Fonarow: The American Heart Association/American Stroke Association will be launching
Target: Stroke Phase II to further improve the timeliness of tPA administration and clinical
outcomes for acute ischemic stroke. The Phase II Program goal is to increase the proportion
of patients with door-to-needle times within 60 minutes to 75% and to achieve door-to-
needle times of 45 minutes or less in at least 50% of patients.
• Citation:
• Door-to-Needle Times for Tissue Plasminogen Activator Administration and Clinical Outcomes
in Acute Ischemic Stroke Before and After a Quality Improvement Initiative
• Gregg C. Fonarow MD, Xin Zhao MS, Eric E. Smith MD, MPH, Jeffrey L. Saver MD, Mathew J.
Reeves PhD, Deepak L. Bhatt MD, MPH, Ying Xian MD, PhD, Adrian F. Hernandez MD, MHS,
Eric D. Peterson MD, MPH, Lee H. Schwamm MD
• JAMA. 2014;311(16):1632-1640. doi:10.1001/jama.2014.3203

Rare Childhood Disorder Enhances Understanding of Resistance to Viral Infections
MedicalResearch.com Interview with: Sergio D. Rosenzweig, MD, PhD
Director, Primary Immunodeficiency Clinic (PID-C)
Head of the Infectious Diseases Susceptibility Unit at the Laboratory of Host Defenses, National Institutes of Allergy and Infectious Diseases
National Institutes of Health Bethesda, MD, 20892
• Dr. Rosenzweig: We diagnosed a disease called CDG-IIb in two siblings with severe
development issues and very low levels of immunoglobulins, which include infection-fighting
antibodies. These children were referred to the NIAID Primary Immunodeficiency Clinic
through the NIH Undiagnosed Diseases Program. CDG-IIb is an extremely rare congenital
disorder of glycosylation (CDG), with only one other case reported. The genetic defect of the
disease disrupts glycosylation, the process for attaching and trimming sugars from proteins.
Almost 50% of our proteins have sugars attached, and these are called glycoproteins. They
include immunoglobulins and also some viral glycoproteins that are made when cells are
infected by a virus. The spread of some viruses, including HIV and influenza, depend on viral
glycoproteins in order to infect additional cells and form viral protective shields. We found
that this type of virus was less able to replicate, infect other cells, or create adequate
protective shields in CDG-IIb patient cells because of the glycosylation defect. In comparison,
adenovirus, poliovirus, and vaccinia virus, which either do not rely on glycosylation or do not
form protective glycoprotein shields, replicated normally when added to both CDG-IIb and
healthy cells.

• Dr. Rosenzweig: While most of our patients’ clinical manifestation fit into what would be
expected in patients with CDGs, the fact that they also presented with severe
hypogammaglobulinemia (low levels of immunoglobulins) but did not have increased rates of
infections was paradoxical, because patients with severe hypogammaglobulinemia typically
have recurrent and severe bacterial and viral infections.

• Dr. Rosenzweig: There are 3 major lessons we learned from these patients:
• First, they taught us that hypogammaglobulinemia not only could arise from production
defects (T and B cell disorders), or loss of immunoglobulins through stools and urine, but also
due to intrinsic immunoglobulin defects related to the glycosylation pattern, which in turn
determines the half life, or stability, of these molecules.
• Second, and perhaps the most important lesson we learned, is that we may potentially treat
individuals with molecules that modify glycosylation, and this may afford protection against
infection from glycosylation-dependent viruses.
• Last, but not least, these children reinforce the concept that by taking care of patients with
very rare diseases, we can learn about basic mechanisms that not only help us to understand
their uncommon diseases but can be generalized and extended for the benefit of the rest of
the population.

of this study?
• Dr. Rosenzweig: We are exploring the possibility of using drugs that modify glycosylation to
prevent and treat certain viral infections that depend on glycoproteins for the infection to
spread. Besides HIV and influenza, which we already show in our work, other candidates may
be dengue, respiratory syncytial virus (RSV) or even ebola virus, all microorganisms with very
important clinical and epidemiological impacts.
•
• Citation:
Brief Report: Glycosylation, Hypogammaglobulinemia, and Resistance to Viral Infections
• M.A. Sadat and Others
NEJM Published Online: April 9, 2014

Diabetes: Nocturnal Hypoglycemia and Risk of Cardiac Arrhythmias
Prof. Simon R. Heller Professor of Clinical Diabetes
Department of Human Metabolism
University of Sheffield, Sheffield, U.K.
• Prof. Heller: We explored the potential to hypoglycaemia to cause cardiac arrhythmias since
we have previously shown that a low glucose can alter the electrocardiogram. We had a
hypothesis that alterations in heart rhythm or ectopic beats might contribute to cardiac
mortality and in part explain the association between intensive diabetic therapy and
increased mortality. We therefore undertook continuous glucose monitoring and 12 lead
EKG monitoring for a period of 5 days in individuals with Type 2 diabetes at increased CV
risk. We found that hypoglycaemia was fairly common and that nocturnal episodes in
particular, were generally marked by a pattern whereby glucose levels dropped to low levels
for some hours during which patients slept. These periods of hypoglycemia were associated
with a high risk of marked slow heart rates (bradycardia) accompanied by ectopic beats. Our
data suggest that this was due to overactivity of the vagus nerve. We have therefore
identified a mechanism which might contribute to increased mortality in individuals with
Type 2 diabetes and high CV risk during intensive insulin therapy.
• Prof. Heller: We were surprised to see how common, prolonged episodes of hypoglycaemia
were in these patients with type 2 diabetes and that these were symptomatic (i.e. patients
slept through them) although such a pattern has been described in people with type 1
diabetes, particularly children. We also didn’t expect to see these very slow heart rates
during nocturnal hypoglycaemic episodes.

Diabetes: Nocturnal Hypoglycemia and Risk of Cardiac Arrhythmias
Prof. Simon R. Heller Professor of Clinical Diabetes
Department of Human Metabolism
University of Sheffield, Sheffield, U.K.
• Prof. Heller: There should be no undue cause of alarm among patients. These slow heart rates
while a cause for concern, were not in this study associated with any very serious heart
rhythms. However it does suggest that even those with standard insulin therapy and who are not
aiming for intensive glucose targets should be aware of the risk of running low overnight
(particularly if they have known cardiovascular disease), perhaps check their blood glucose in the
middle of the night every now and then and work with their doctor to either change insulin dose
timing or type to minimize the risk of prolonged episodes of hypoglycemia overnight.
• Clinicians responsible for the care of insulin treated patients with type 2 diabetes need to be more
aware of the potential for prolonged nocturnal episodes of hypoglycemia at night to check for it
and alter therapy to reduce the risk especially for those who have known CV disease.
• MedicalResearch.com: What recommendations do you have for future research as a result of this
study?
• Prof. Heller: More research of this type needs to be undertaken, with larger numbers, perhaps with
Holter monitoring to see how common these abnormal heart rates and rhythms are occurring in
people with type 2 diabetes at CV risk. More studies of the effect of hypoglycaemia on nerve
function affecting the heart (autonomic nervous system) should also be undertaken, particularly in
patients with diabetes.
• Citation:
• Elaine Chow, Alan Bernjak, Scott Williams, Robert A. Fawdry, Steve Hibbert, Jenny Freeman, Paul J.
Sheridan, and Simon R. Heller
• Risk of Cardiac Arrhythmias During Hypoglycemia in Patients With Type 2 Diabetes and
Cardiovascular Risk Diabetes May 2014 63:5 1738-1747; doi:10.2337/db13-0468 1939-327X

Vitamin D Did Not Alter Risk of Falls
Dr Mark Bolland, PhD
Bone and Joint Research Group, Department of Medicine
University of Auckland, Auckland, New Zealand
• Prof. Bolland: In a meta-analysis of 20 randomized clinical trials, there was no effect of vitamin D with or without calcium on
falls. In a trial sequential analysis of these trials, the effect estimate for vitamin D with or without calcium on falls lay within
the futility boundary, providing reliable evidence that vitamin D supplementation does not alter the relative risk of falls by
≥15% and suggesting that future trials that are similar in design to current trials are unlikely to change that conclusion.
•
• Prof. Bolland: Previously meta-analyses have reported conflicting results on the effect of vitamin D on falls, but a number of
large, fairly recent randomised clinical trials have reported either harm or no effect of vitamin D on falls. The most recent
meta-analyses that include these trials, generally report similar findings to ours. The results are in broad agreement with a
number of recent meta-analyses and systematic reviews that report no effect of vitamin D supplements in community
dwelling individuals on a very broad range of health outcomes including fracture, bone density, cancer, and cardiovascular
events.
• Prof. Bolland: There is little justification currently for prescribing vitamin D to prevent falls. People who are at risk of
osteomalacia because of very low vitamin D levels (frail elderly people living in residential care, people who actively avoid
the sun, and people with deeply pigmented skin) should consider taking vitamin D supplements. For others, vitamin D
supplements are not necessary.
• Prof. Bolland: Research should focus on better defining what vitamin D level is adequate for health, rather than carrying out
more trials of vitamin D supplements that are similar to the existing ones.
• Citation:
The effect of vitamin D supplementation on skeletal, vascular, or cancer outcomes: a trial sequential meta-analysis
Dr Mark J Bolland PhD,Andrew Grey MD,Greg D Gamble MSc,Prof Ian R Reid MD
The Lancet Diabetes & Endocrinology – 1 April 2014 ( Vol. 2, Issue 4, Pages 307-320 )
DOI: 10.1016/S2213-8587(13)70212-2

Cannabis Associated Cardiovascular Complications Increase
Emilie Jouanjus, PharmD, PhD
Risques, maladies chroniques et handicaps Facult_e de M_edecine,
Guesde, Toulouse 31073, France.
• Dr. Jouanjus: Our study emphasizes that cardiovascular complications make up 1.8 percent of
cannabis-related health complications reported in France. These were cases of peripheral
arteriopathies, and cardiac and cerebrovascular disorders, some of which resulted in the
death. These findings conducted us to conclude that marijuana is a possible risk factor for
cardiovascular disease in young adults.
• MedicalResearch.com: Were any of the results unexpected?
• Dr. Jouanjus: In a previous study, we had been stunned to observe several very serious cases
of cardiovascular complications in young cannabis users (Jouanjus et al. British Journal of
Clinical Pharmacology, 2011: 71; 758-65). With the present work, we were willing to explore
at the national level whether such cases were described, and to survey their evolution across
time. Cardiovascular or cerebrovascular disorders and peripheral arteriopathies arisen in 34
years old (on average) cannabis users confirmed our fears. Cases were remarkably serious, or
even lethal. Moreover, their report has constantly increased, especially during the last three
observed years. This result is surprising considering that cardiovascular complications, when
toxic cause is suspected, are more commonly attributed by doctors to cocaine or
amphetamine use. These results raise concern about the harmful potential of marijuana and
its impact on public health, notably because its medicinal use has become more prevalent in
particular since some governments are legalizing its use.

Cannabis Associated Cardiovascular Complications Increase
Emilie Jouanjus, PharmD, PhD
Risques, maladies chroniques et handicaps Facult_e de M_edecine,
Guesde, Toulouse 31073, France.
• Dr. Jouanjus: Cannabis use is commonly thought to be harmless, however, there is now compelling
evidence on the growing risk of cannabis-associated adverse cardiovascular effects, especially in
the Young. It is therefore important that users as well as clinicians be aware of this. Doctors,
including cardiologists, must consider cannabis use as one of the potential causes of cardiovascular
disorders. Indeed, exposure to cannabis should be systematically investigated in patients presenting
with cardiovascular problems. This should contribute to improve the clinical management of
cannabis using patients, as well as prognosis of the pathologies their suffer from.
study?
• Dr. Jouanjus: The surveillance of cannabis-related reports of cardiovascular disorders needs to be
maintained. Furthermore, fundamental experiments would be of interest to ascertain the
mechanisms through which cannabis may trigger such cardiovascular disorders, especially since its
medicinal use is increasing. Actually, the precise pathways involved are still debated and remain
somehow controversial. Their elucidation would help in understanding how harmful cannabis may
be, in particular in young people. The return expected concerns prevention and therapeutics, with
meaningful impact towards public health.
• Citation:
• Cannabis Use: Signal of Increasing Risk of Serious Cardiovascular Disorders
• Emilie Jouanjus, PharmD, PhD; Maryse Lapeyre-Mestre, MD, PhD; Joelle Micallef, MD, PhD; The
French Association of the Regional Abuse
• and Dependence Monitoring Centres (CEIP-A) Working Group on Cannabis Complications*
• Journal of the American Heart Association Journal Report: April 23 2014

Bone Mineral Density: What is Impact of Change in Physician Reimbursement?
Susan Jaglal, PhD
Senior Scientist Toronto Rehabilitation Institute University of Toronto,
Toronto, Ontario
• Dr. Jaglal: Bone Mineral Density (BMD) tests are used to both diagnose osteoporosis and assess and individual’s risk of fracture. While the tests play
an important role in bone health, they are sometimes ordered inappropriately. For example, while women age 40-44 are typically not at risk of
fragility fracture or in need of Bone Mineral Density testing, these individuals received almost half the Bone Mineral Density tests performed in
Ontario in 2007/2008.
• Policy changes have been made in recent years in an effort to curb unnecessary testing of low risk individuals in both the United States and Canada.
Policy efforts in Ontario included a 2008 fee schedule change that limited repeated testing among low-risk patients and included a new fee code for a
“baseline” tests. Patients were limited to 1 baseline test in their lifetime.
• The goal of the present study was to determine the impact of this fee schedule change on Bone Mineral Density testing rates. The study was based
on an analysis of provincial administrative data including physician billings, hospital discharges, and emergency department visits.
• Results demonstrated that while fee schedule changes were associated with a decrease in BMD testing rates, the decreases affected both low and
high-risk patients. Most decreases were seen in testing rates of low-risk women. However, the associated decrease in testing among high-risk
patients (e.g., those over 65 or with a recent fracture) is concerning, as high-risk patients benefit from screening and monitoring of Bone Mineral
Density.
• Dr. Jaglal: Current clinical guidelines for Bone Mineral Density testing need to be better communicated to both clinicians and patients. Osteoporosis
Canada currently suggests baseline Bone Mineral Density testing for all men and women who are over age 65. Men and women who are over 50 and
have clinical risk factors for fracture, like low body weight or history of fragility fracture, should also be tested. Clinicians should be aware that men
and women under age 50 typically should not be tested unless major risk factors for bone loss exist.
• While it is important to curb testing rates among low risk women (i.e., those under age 50), this cannot be done at the expense of testing individuals
who are genuinely at risk. Testing rates for individuals following a recent fragility fracture were low before fee schedule changes and are now lower.
Similarly, testing rates in Ontario for eligible seniors remain below 50% and have been declining among women since fee schedule changes. These
two groups of at-risk patients need to be better identified in practice and screened.
• Dr. Jaglal: Why the change in the Ontario fee schedule reimbursement was associated with such a dramatic decrease in the rate of testing among
patients with recent fracture is of particular concern. Additional research to understand the failure to enforce guidelines in this patient population is
required. What is not known from this study is the appropriateness of testing. Future research needs to determine if those who were not tested
more likely to have normal Bone Mineral Density. This would require information on BMD test result.
• Citation:
• Susan Jaglal, Gillian Hawker, Ruth Croxford, Cathy Cameron, Anne-Marie Schott, Sarah Munce, and Sonya Allin
• Impact of a change in physician reimbursement on bone mineral density testing in Ontario, Canada: a population-based study cmajo 2:E45-E50;
published online March 31, 2014, doi:10.9778/cmajo.2013-0052

Dementia Symptoms Management in Clinical Settings: Panel Recommendations
MedicalResearch.com Interview with Helen C. Kales MD
Professor of Psychiatry Director, Section of Geriatric Psychiatry and The Program for Positive Aging, University of Michigan
Research Scientist, VA Center for Clinical Management Research and Geriatric Research Education and Clinical Center
VA Ann Arbor Healthcare System
• Please note that this paper is the result of the deliberations of a multi-disciplinary national expert
panel, not a specific study.
• MedicalResearch.com: What were the main findings of the expert panel?
• Dr. Kales: Often more than memory loss, behavioral symptoms of dementia are among the most
difficult aspects of caring for people with dementia. These symptoms are experienced almost
universally, across dementia stages and causes, and are often associated with poor outcomes
including early nursing home placement, hospital stays, caregiver stress and depression, and
reduced caregiver employment. Doctors often prescribe these patients psychiatric medications like
antipsychotics, despite little hard evidence that they work well in this population and despite the
risks they pose including hastening death. Meanwhile, studies show promise for non-medication
behavioral and environmental approaches (such as providing caregiver education/support, creating
meaningful activities and simplifying/enhancing the environment), but too few health providers are
trained in their use. The method created by the national multidisciplinary group of experts (DICE
which stands for Describe, Investigate, Create and Evaluate) represents a comprehensive approach
to assessment and management of behavioral symptoms in dementia. For example, a new report
of “agitation” from a caregiver, should be fully understood and described (e.g.
who/what/when/where/risk/safety); underlying causes should be investigated (e.g. pain, changes
in medications, medical conditions, poor sleep, fear); a treatment plan should be created (e.g.
responding to physical problems, working collaboratively with the caregiver and other team
members to institute non-pharmacologic interventions); and evaluating whether the interventions
tried were effective.

• Dr. Kales: Given the mixed evidence-base for most psychotropics used for behavioral
symptoms of dementia, several of the expert panelists were hesitant recommend first-line
treatment with medications under any circumstances. Others noted that lack of
homogeneity of behavioral symptoms in prior trials may have been problematic. Given the
limitations of the current evidence base, the panel consensus was that psychotropic drugs
should only be used after significant efforts have been made to mitigate behavioral
symptoms using behavioral and environmental modifications and medical interventions (e.g.
treatment of a urinary tract infection that could underlie behavioral changes), with three
exceptions. In each of the three “exceptions”, medication use would follow a concern for
significant and imminent risk:
• · Major depression with or without suicidal ideation
• · Psychosis causing harm or great potential of harm
• · Aggression causing risk to self or others
• If medications are used, close followup is needed to monitor for adverse effects and use
should be time-limited as behaviors and symptoms may resolve over time with or without
drug intervention.

• MedicalResearch.com: What should clinicians and patients take away from this report?
• Dr. Kales: The DICE approach offers clinicians an evidence-informed structured approach that
can be integrated into diverse practice settings. The approach is inherently patient- and
caregiver- centered because the concerns of individuals with dementia and their caregivers
are integral to each step of the process. DICE enables clinicians to consider conjointly the
role of nonpharmacological, medical and pharmacologic treatments.
of this study?
• Dr. Kales: Ultimately, developing technology applications of DICE (e.g. in the form of an
“app”) may simplify its use, save time, standardize its application and facilitate evaluation of
its effectiveness. Drs. Kales and Gitlin are Co-PIs on a grant from the National Institute of
Nursing Research (R01NR014200) creating and testing the approach using technology with
the benefit of key stakeholder (patient, caregiver and provider) input.
• Citation:
• Management of Neuropsychiatric Symptoms of Dementia in Clinical Settings:
Recommendations from a Multidisciplinary Expert Panel
Kales HC1, Gitlin LN, Lyketsos CG; Detroit Expert Panel on the Assessment and Management
of the Neuropsychiatric Symptoms of Dementia.
J Am Geriatr Soc. 2014 Apr;62(4):762-9. doi: 10.1111/jgs.12730. Epub 2014 Mar
•

Autism and Prenatal Exposure to SSRIs
MedicalResearch.com Interview with Li-Ching Lee, PhD, ScM
Associate Scientist, Departments of Epidemiology and Mental Health
Johns Hopkins Bloomberg School of Public Health
Baltimore MD 21205
• Dr. Li-Ching Lee: This population-based case-control study in young children provides evidence that
prenatal selective serotonin reuptake inhibitor (SSRI) use may be a risk factor for autism and other
developmental delays (DD). Among boys, prenatal SSRI exposure was nearly 3 times as likely in
children with autism spectrum disorder (ASD) relative to children with typical development; the
strongest association occurred with first-trimester exposure. Exposure was also elevated among
boys with DD and was strongest in the third trimester.
• MedicalResearch.com: Were any of the findings different from previous studies?
• Dr. Li-Ching Lee: Recent ASD studies using electronic medical records and registries included large
samples of pregnant women with prospectively collected medication use. However, ASD diagnoses
were not validated. Furthermore, studies by Croen et al (2011) using Kaiser patients and by Hviid et
al (2013) using Danish registries were unable to confirm whether dispensed SSRIs were actually
taken by mothers, whereas the Rai et al (2013) study from Stockholm, Sweden, only included self-
reported use at the first antenatal visit. The Kaiser and Swedish studies reported modestly
increased autism spectrum disorder risk among children prenatally exposed to SSRIs, independent
of maternal mental health, whereas no significant differences were observed in the Danish cohort.
Similar to our results, the Kaiser study found the highest risk with first-trimester use. The Swedish
study could not assess timing of use. Neither assessed differences in SSRI effects by child gender.
Similar to the Danish cohort results, we found no association when boys and girls were combined.
Hviid et al reported no data on gender, nor gender-stratified analyses.

Autism and Prenatal Exposure to SSRIs
MedicalResearch.com Interview with Li-Ching Lee, PhD, ScM
Associate Scientist, Departments of Epidemiology and Mental Health
Johns Hopkins Bloomberg School of Public Health
Baltimore MD 21205
• Dr. Li-Ching Lee: Because of low exposure prevalence and possible cofactors influencing susceptibility
to autism spectrum disorder from SSRI exposure, any contribution of these medications to the increase in
autism diagnoses over time is likely minimal. The reported results must be viewed in the context of the
disorder SSRIs are used to treat and, particularly, with the risks associated with failure to treat the
condition. Maternal depression during pregnancy has itself been linked to preterm birth, fetal growth
restriction, and preeclampsia, as well as increased irritability in newborns and reduced activity and
attentiveness compared with infants of nondepressed women. Given these negative consequences,
depression during pregnancy and the positive aspects of pharmacologic management present pregnant
women and their doctors with complex treatment decisions. The benefits of treating depression with
SSRIs during pregnancy should continue to be carefully weighed against any potential risk of harm.
• Dr. Li-Ching Lee: Whether the risk of DDs other than autism spectrum disorder is also elevated in
association with prenatal SSRI exposure requires confirmation with a larger sample size; research might
usefully address how maternal SSRI use is affected by the knowledge of predisposing genetic conditions.
Also needed are studies in more girls, sufficient sample sizes to address possible differential effects from
specific SSRIs, and attention to mechanisms by which SSRIs might influence autism spectrum disorder and
other developmental outcomes. The field would benefit from a deeper understanding of the contribution
of maternal and fetal genetics in regulating serotonin.
• Citation:
Prenatal SSRI Use and Offspring With Autism Spectrum Disorder or Developmental Delay
• Rebecca A. Harrington, Li-Ching Lee, Rosa M. Crum, Andrew W. Zimmerman, and Irva Hertz-Picciotto
• Pediatrics peds.2013-3406; published ahead of print April 14, 2014, doi:10.1542/peds.2013-3406

Stroke: Specialized Ambulances Improved Treatment Time, Costs May Be Prohibitive
MedicalResearch.com Interview with: Priv.-Doz. Dr. med. Dr. phil. Martin Ebinger
Oberarzt der Klinik und Hochschulambulanz für Neurologie am Campus Charité Mitte
Center for Stroke Research Berlin (CSB) Charitéplatz 1 | 10117 Berlin | Germany
• Dr. Ebinger: The main findings of our study was a significant time reduction during randomized
weeks with prehospital thrombolysis compared to control weeks with regular care.
MedicalResearch.com: What should clinicians and patients take away from your report?
• Dr. Ebinger: Prehospital thrombolysis increased thrombolysis rate to 33%, reduced time from
alarm-to-treatment and was not associated with increased risks.
study?
• Dr. Ebinger: Researchers in emergency medicine may rethink the opportunities to place certain
time critical interventions into the prehospital phase.
Citation:
• Effect of the Use of Ambulance-Based Thrombolysis on Time to Thrombolysis in Acute Ischemic
Stroke: A Randomized Clinical Trial
Martin Ebinger MD, Benjamin Winter MD, Matthias Wendt MD, Joachim E. Weber MD, Carolin
Waldschmidt MD, Michal Rozanski MD, Alexander Kunz MD, Peter Koch MD, Philipp A. Kellner MD,
Daniel Gierhake MD, Kersten Villringer MD, Jochen B. Fiebach MD, Ulrike Grittner PhD, Andreas
Hartmann MD, Bruno-Marcel Mackert MD, Matthias Endres MD, Heinrich J. Audebert MD
• JAMA. 2014;311(16):1622-1631. doi:10.1001/jama.2014.2

Brain AV Malformations: Conservative Treatment May Be Best For Stable Lesions
MedicalResearch.com Interview with: Rustam Al-Shahi Salman
Professor of clinical neurology and MRC senior clinical fellow
University of Edinburgh
Honorary consultant neurologist, NHS Lothian
• Prof. Al-Shahi Salman: Patients with arteriovenous malformations (abnormal connection between
arteries and veins) in the brain that have not ruptured had a lower risk of stroke or death for up to
12 years if they received conservative management of the condition compared to an
interventional treatment.
• Interventional treatment for brain arteriovenous malformations (bAVMs)
with procedures such as neurosurgical excision, endovascular
embolization, or stereotactic radiosurgery can be used alone or in
combination to attempt to obliterate bAVMs. Because interventions may
have complications and the untreated clinical course of unruptured
bAVMs can be benign, some patients choose conservative management (no
intervention). Guidelines have endorsed both intervention and
conservative management for unruptured brain arteriovenous malformations. Whether
conservative management is superior to interventional treatment for unruptured
bAVMs is uncertain because of the lack of long-term experience,
according to background information in the article.
• Rustam Al-Shahi Salman, Ph.D., of the University of Edinburgh,
Scotland, and colleagues with the Scottish Audit of Intracranial
Vascular Malformations Collaborators, studied 204 residents of
Scotland (16 years of age or older) who were first diagnosed as having
an unruptured bAVM during 1999-2003 or 2006-2010 and followed over
time. The researchers analyzed the outcomes for patients who received
conservative management (no intervention; medications for seizures) or
an intervention (any endovascular embolization, neurosurgical
excision, or stereotactic radiosurgery alone or in combination).

• Of the 204 patients, 103 underwent some type of intervention. Those
who underwent intervention were younger, more likely to have presented
with seizure, and less likely to have large bAVMs than patients
managed conservatively. During a median (midpoint) follow-up of 6.9
years, the rate of progression to sustained disability or death was
lower with conservative management during the first 4 years of
follow-up, but rates were similar thereafter. The rate of nonfatal
stroke or death (due to the brain arteriovenous malformation or intervention) was lower with
conservative management during 12 years of follow-up (14 vs 38 events).
• Prof. Al-Shahi Salman: These findings are very similar to the results of the ARUBA trial,
recently published in The Lancet. Comparing this population-based
observational study and the ARUBA trial, treated participants were
similar in age and sex, and in the frequencies of incidental
presentation, bAVM location, superficial venous drainage
pattern, and Spetzler-Martin grades. The frequency of multimodality
intervention was similar in ARUBA and this observational study. In the
conservative management group, the event rate was similar in ARUBA and
this observational study. Finally, the association between
conservative management and stroke or death related to bAVM or its
intervention during 12 years in the observational study (adjusted
hazard ratio [HR] 0·37, 95% CI 0·19–0·72) was similar to the effect of
conservative management on stroke or death of any cause during 6 years
in the ARUBA randomised analysis (0·27, 0·14–0·54).

• Prof. Al-Shahi Salman: The similarity of the results of this observational study and ARUBA
and the persistent difference between the outcome of conservative
management and intervention during 12-year follow-up in our study
support the superiority of conservative management to intervention for
unruptured bAVMs, which may deter some patients and physicians from
intervention.
of this study?
• Prof. Al-Shahi Salman: Long-term follow-up in both this study and the ARUBA trial is needed
to establish whether the superiority of conservative management will
persist or change.
• Citation:
• Outcome After Conservative Management or Intervention for Unruptured Brain
Arteriovenous Malformations
• Rustam Al-Shahi Salman PhD, Philip M. White FRCR, Carl E. Counsell MD, Johann du Plessis
FRCR, Janneke van Beijnum MD, Colin B. Josephson MD, Tim Wilkinson MRCP, Catherine J.
Wedderburn MBChB, Zoe Chandy MB, ChB, E. Jerome St. George FRCS, SN, Robin J. Sellar
FRCR, Charles P. Warlow FRCP
• JAMA. 2014;311(16):1661-1669. doi:10.1001/jama.2014.3200

Cancer Survivors: Discussions of Survivorship Have Room For Improvement
Danielle Blanch Hartigan, PhD, MPH
Cancer Prevention Fellow
National Cancer Institute
• Dr. Blanch-Hartigan: Results from this nationally-representative survey of oncologists and
PCPs suggest that discussion of survivorship care planning with cancer survivors does not
always occur. Training and knowledge specific to survivorship care and coordinated care
between PCPs and oncologists were associated with increased survivorship discussions with
survivors.
•
• Dr. Blanch-Hartigan: Less than 5% of oncologists nationwide reported consistently giving
survivors a written survivorship care plan and having discussions of follow-up care with
survivors.

Cancer Survivors: Discussions of Survivorship Have Room For Improvement
Danielle Blanch Hartigan, PhD, MPH
Cancer Prevention Fellow
National Cancer Institute
• Dr. Blanch-Hartigan: Creating a written survivorship care plan may not be enough;
oncologists and PCPs should involve survivors in the survivorship care planning process
through discussions of recommendations for follow-up care.
of this study?
• Dr. Blanch-Hartigan: In addition to providing a benchmark to assess implementation of new
survivorship care mandates, future research should develop intervention studies to test the
hypothesis that improved care coordination and enhanced physician survivorship training will
increase the frequency of survivorship care discussions and downstream positive health
outcomes for the survivor.
•
• Citation:
• Provision and Discussion of Survivorship Care Plans Among Cancer Survivors: Results of a
Nationally Representative Survey of Oncologists and Primary Care Physicians
• Danielle Blanch-Hartigan, Laura P. Forsythe, Catherine M. Alfano, Tenbroeck Smith, Larissa
Nekhlyudov, Patricia A. Ganz, and Julia H. Rowland
• JCO JCO.2013.51.7540; published online on April 21, 2014;

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