MedicalResearch.com Interview with:
Dr. Michael Bailey, Ph.D.
Senior Principal Engineer
Assistant Professor, Mechanical Engineering
and Adjunct Assistant Professor, Urology
University of Washington
Medical Research: What is the background for this study? What are the main findings?
Dr. Bailey: Ultrasonic propulsion is a new technology that uses focused ultrasound energy to reposition kidney stones transcutaneously. We report the findings from the first human investigational trial of ultrasonic propulsion toward the applications of expelling small stones and dislodging large obstructing stones. Subjects underwent ultrasonic propulsion either awake without sedation or during ureteroscopy while anesthetized. A pain questionnaire was completed before, during, and after propulsion for awake subjects. Potential adverse events were assessed weekly for 3 weeks after propulsion for all subjects.
The primary outcome was to reposition stones in the collecting system. Secondary outcomes included safety, controlled movement of stones, and movement of stones < 5 mm and ≥ 5 mm. Stones were localized and repositioned in 14 of 15 enrolled subjects. Of the 43 targets, 28 (65%) showed some level of movement while 13 (30%) were displaced to a new location > 3 mm. No adverse events were reported. Mild discomfort during the procedure was rare, brief, and self-limited. Stones were moved in a controlled direction with over 30 fragments being passed by most patients who previously had a lithotripsy procedure. The largest stone moved was 10 mm. One patient experienced pain relief during treatment of an obstructing stone. In 4 subjects a seemingly large stone, which might have required surgery, was determined to be a cluster of small passable stones.
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MedicalResearch.co Interview with:
Katherine Ornstein, PhD MPH
Assistant Professor
Brookdale Department of Geriatrics and Palliative Medicine
Institute for Translational Epidemiology
Icahn School of Medicine at...
MedicalResearch.com Interview with:
David S. Lopez, Dr.P.H., M.P.H.
Assistant professor
University of Texas Health School of Public Health
Medical Research: What is the background for this study? What are the main findings?
Dr. Lopez: Coffee, and its most studied component, caffeine, have been implicated in potential health benefits due to the rich sources of antioxidants and anti-inflammatory compounds contained in this beverage.
Caffeine intake reduced the odds of prevalent erectile dysfunction, especially an intake equivalent to approximately 2-3 daily cups of coffee (170-375 mg/day). This reduction was also observed among overweight/obese and hypertensive men, but not among diabetic men. These associations are warranted to be investigated in prospective studies.
Medical Research: What are the main findings?Dr. Lopez: Caffeine intake reduced the odds of prevalent erectile dysfunction, especially an intake equivalent to approximately 2-3 daily cups of coffee (170-375 mg/day). This reduction was also observed among overweight/obese and hypertensive men, but not among diabetic men. These associations are warranted to be investigated in prospective studies.
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MedicalResearch.com Interview with:
Robert E Kalb, M.D.
Clinical Professor of Dermatology
State University of New York at Buffalo School of Medicine and Biomedical Sciences
Buffalo Medical Group, P.C.
Buffalo, NY 14221
Medical Research: What is the background for this study? What are the main findings?Dr. Kalb: It's important to evaluate the safety of biologics in the real world post-marketing setting, and in particular with respect to serious infections. We studied patients with psoriasis in the PSOLAR registry and evaluated the risk of various biologic therapies. We found that infliximab and adalimumab were associated with increased risk of serious infections when compared with non-biologic/non-methotrexate therapies, while ustekinumab and etanercept were not associated with increased risk. (more…)
MedicalResearch.com Interview with:
Wei Zhang, Ph.D., Professor
Department of Pathology
Director, Cancer Genomics Core Lab
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Medical Research: What is the background for this study? What are the main findings?
Dr. Zhang: Epithelial ovarian cancer remains the most lethal gynecological malignancy. The 5-year survival rate for patients with advanced ovarian cancer is only 30-40%, and acquired resistance to platinum is considered a major factor in disease relapse. A major challenge in cancer treatment is the resilient ability of cancer cells to repair DNA damage caused by chemotherapy agents. In this study, we found that adding a molecule called miR-506 to standard chemotherapy can help cells overcome drug resistance, so that the chemotherapy drugs remain effective against ovarian cancer. This research supports a new combination approach, which may substantially benefit patients with this deadly disease.
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MedicalResearch.com Interview with:
Ulka Agarwal, M.D.
California State University, East Bay
Student Health and Counseling Services
Hayward, CA
MedicalResearch: What is the background for this study? What are the main findings?Dr. Agarwal: Diabetic peripheral neuropathy affects 60 percent of patients with type 2 diabetes and can come with painful symptoms but limited treatment options. We thought a dietary intervention may help alleviate these symptoms since glycemic control plays a role in diabetes complications.
To get started with the pilot, we put 17 adults on a low-fat vegan diet for 20 weeks and prescribed weekly nutrition classes. We found significant improvements in pain, measured by the Short Form McGill Pain questionnaire, the Michigan Neuropathy Screening Instrument physical assessment, and through electrochemical skin conductance in the foot. The participants also lost an average of 14 pounds.
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MedicalResearch.com Interview with:
Catterina Ferreccio, MD, MPH
School of Medicine
Pontificia Universidad Católica de Chile
Santiago, Chile
Medical Research: What is the background for this study? What are the main findings?
Dr. Ferreccio: In Chile, gallbladder cancer (GBC) is the 2nd highest cause of cancer death in women. Other than gallstones no other causal factors have been identified. We conducted a pilot case-control study of gallbladder cancer to evaluate its association with aflatoxin B1 (AFB1) exposure. Aflatoxins are toxics products of the fungis Aspergillus flavus and Aspergillus parasiticus and are contaminants of food; AFB1 is carcinogenic. Usually they are found in areas closer to the Equator than Chile.
Main findings were the high proportion (35%) of study subjects carrying aflatoxins adducts and the particularly high exposure among the Gallbladder cancer (GBC) cases (64%) compared with gallstones controls (18%) or with population controls (23%).
Difference of gallbladder cancer vs controls were statistically significant and suggests aflatoxins may be a significant risk factor for gallbladder cancer; hypothesis never tested before.
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MedicalResearch.com Interview with :
Prof. Alexandre Reymond
Director, Center for Integrative Genomics
University of Lausanne
Lausanne Switzerland
MedicalResearch : What is the background for this study?Prof. Reymond: Though a subset of recurrent DNA copy number variants (differing numbers of copies of genetic sequence at locations in the genome; CNVs) with rare population prevalence are known to have strong impact on carrier’s health, up to now their association with phenotypes such as intellectual disability has been almost exclusively evaluated in clinical context using individuals ascertained for diagnostics of developmental disorders. Thus the contribution of these genetic variants to health, cognition and life quality in the general population remains unclear. We used a population biobank, that of Estonia (Estonian Genome Center, University of Tartu), which contains samples from 52,000 adult participants (representative 5% of the country’s adult population), a British birth cohort (The Avon Longitudinal Study of Parents and Children; ALSPAC) and two more population-based cohorts from the USA and Italy to explore the consequences of CNVs in presumptively healthy populations.
MedicalResearch : What are the main findings?Prof. Reymond: Rare recurrent CNVs known to be causative for specific syndromes (termed genomic disorders) have a global population prevalence of around 1%. Contrary to popular assumption that carriers of these syndromic CNVs identified in unselected, but assumed to be healthy, adult population cohorts are asymptomatic, we found that they are associated with unrecognized, but serious clinical sequelae.
Additionally our results showed that individually rare (less than 1 in 2000 individuals) but collectively common (around 10% of population) intermediate-size CNVs are negatively associated with carriers’ educational attainment. Altogether our results suggest that the life quality of at least 1 of 40 people might be negatively affected by rare CNVs.
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MedicalResearch.com Interview with:Professor Ramsey Cutress
Associate Professor in Breast Surgery
University of Southampton
Medical Research: What is the background for this study? What are the main findings?Response: The main finding is that in young women with breast cancer, a breast cancer family history of breast cancer did not affect recurrence rates.
This work forms part of the Prospective Outcomes in Sporadic versus Hereditary breast cancer (POSH) study, which included 2850 women under age 41 years who were diagnosed with breast cancer and treated in the UK. The study, led by principal investigator Professor Diana Eccles, recorded patients’ personal characteristics, tumour characteristics, treatment, and family history of breast/ovarian cancer over a 15-year period.
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MedicalResearch.com Interview with:
Dr. Michael Eriksen Benrós
Mental Health Centre Copenhagen
University of Copenhagen Faculty of Health Sciences
Copenhagen NV, Denmark,
National Centre for Register-based Research
Aarhus University Denmark
Medical Research: What is the background for this study?
Response: It is increasingly recognized that infections and immune responses can affect the brain and activate immunocompetent cells within the brain, influencing on neuronal signal transduction and possibly cognition. Impaired cognition has been observed in association with several infections and with elevated levels of CRP in smaller studies. Furthermore, experimental activation of inflammatory reactions in healthy volunteers has been shown to induce short-term reduced cognitive performance. Moreover, particularly patients with infection in the brain or sepsis have been shown to have affected cognition in long time periods after the infection has been cleared, thus infections might also have a longer lasting effect on cognition. However, large-scale longitudinal studies had been lacking on the association between infections and cognitive ability in the general population.
Medical Research: What are the main findings?
Response: Our study is the first large-scale study utilizing the extensive Danish registers to follow 190,000 males that had their IQ assessed at conscription, out of which 35% had a previous hospital contact with infection before the IQ testing was conducted. Our research shows a correlation between severe infections with a hospital contact and subsequent impaired cognition corresponding to an IQ score of 1.76 lower than the average. People with five or more hospital contacts with infections had an IQ score of 9.44 lower than the average. The study thus shows a clear dose-response relationship between the number of infections. Furthermore the effect on cognitive ability increased with the temporal proximity of the last infection and with the severity of the infection. Infections in the brain affected the cognitive ability the most, but many other types of infections severe enough to require a hospital contact where also associated with impairment of the cognitive ability.
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MedicalResearch.com Interview with:
Enayet Karim Chowdhury, Research Fellow
Department of Epidemiology and Preventive Medicine
School of Public Health and Preventive Medicine
Monash University The Alfred Centre
Melbourne VIC 3004
Medical Research: What is the background for this study? What are the main findings?
Dr. Chowdhury: The study was conducted on elderly treated hypertensive population. Australia is currently undergoing a demographic transition towards having increasing number of older people. As age advances quality of life becomes increasingly affected by a variety of chronic diseases including poor renal function. Therefore early detection and management of the risk associated with these chronic diseases is crucial. Managing hypertension, even though challenging, can significantly improve quality of life of a person by reducing risk of having cardiovascular events. The main finding of the study is that in elderly treated hypertensive people, a rapid decline in renal function was associated with a higher risk of having cardiovascular events irrespective of having chronic kidney disease or not. (more…)
MedicalResearch.com Interview with:
Dr. Simon Cheng PhD.
Department of Sociology
University of Connecticut, Storrs, CT
Medical Research: What is the background for this study? What are the main findings?
Dr. Cheng: Our research is an empirical response to the Regnerus study, one of the most visible and controversial articles ever published in the social sciences. His study concluded that individuals raised by a gay or lesbian parent display less favorable adulthood outcomes than those who grew up in intact biological families. There have been many debates about the study’s conclusion and analysis, but we (Cheng and Powell) are the first to reassess Regnerus’s findings by analyzing his own data. Our reanalysis seriously calls into question his conclusions. We find that a large number of the people studied in the Regnerus study likely were misclassified as living with gay/lesbian parents. The misclassifications took several forms:
Of the 236 people Regnerus defined as being raised by a “lesbian mother” or “gay father’ 24 (10%) report that they actually never lived with that parent
An additional 34 (14%) report that they lived with that parent for a year of less.
The 236 people include some questionable responses that lead us to doubt the seriousness of the person completing the survey. The most notable example is a 25 year-old man who reports that his father had a romantic relationship with another man, but also reports that he (the respondent) was 7-feet 8-inches tall, weighted 88 pounds, was married 8 times, and had 8 children. Another person claims to have been arrested at age 2.
The 236 people also include responses that at best are inconsistent and illogical. For example, one person repots “having always live alone but also claims to have always lived with the mother, father, and two grandparents.”
After reviewing each case, we demonstrated that at least one-third and up to two-fifths were miscounted by Regnerus as having been raised by gay or lesbian parents. Regnerus’s disputable findings are due to these misclassifications and other questionable methodological choices. When the analyses are more carefully done, our results show minimal differences between young adults who were raised by gay and lesbian parents and young adults who were raised by heterosexual parents. (more…)
MedicalResearch.com Interview with:
Ms. Pajau Vangay
Graduate Research Fellow
Biomedical Informatics and Computational Biology
Vice President of Grants, Council of Graduate Students
University of Minnesota
Medical Research: What is the background for this study? What are the main findings?
Response: Previous studies showed links between antibiotic use and unbalanced gut bacteria, and others showed links between unbalanced gut bacteria and adult disease. Over the past year we synthesized hundreds of studies and found evidence of strong correlations between antibiotic use, changes in gut bacteria, and disease in adulthood.
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MedicalResearch.com Interview with:
Marie Crandall, MD, MPH, FACS
Associate Professor of Surgery
Northwestern University Feinberg School of Medicine
Chicago, IL 60611
Medical Research: What is the background for this study? What are the main findings?
Dr. Crandall: While the association between alcohol and interpersonal violence has been well established, research has been divided with respect to the direct effect of proximity to an establishment with a liquor license and violence. We used geographic regression analysis, which is a type of multivariate regression including geography as a variable, to examine the association between proximity to an establishment with a liquor license, such as a liquor store or tavern, and gun violence in Chicago.
We utilized our state trauma registry and geocoded 11,744 gunshot wounds that occurred between 1999-2009. On the assumption that different neighborhoods might experience risk differently, we used a combination of ordinary least squares and geographic regression analysis to identify homogenous areas with similar risk. We used sociodemographic variables as covariates in the analysis.
We found that the impact of proximity to an establishment with a liquor license and occurrence of gunshot wounds varied markedly by neighborhood. The areas of highest risk were found to have enormous associations, Odds Ratios (OR) greater than 500. These areas also tended to be more socioeconomically distressed areas of the city.
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MedicalResearch.com interviewDorota Kaminska, MSc
Department of Clinical Nutrition
University of Eastern FinlandMedicalResearch: What is the background for this study? What are the main findings?Response: The prevalence of obesity is increasing worldwide, making it one of the biggest health problems currently facing both developed and developing countries. Obesity is considered a primary risk factor for developing type 2 diabetes. While the majority of people with type 2 diabetes are obese, most of obese people do not develop diabetes, indicating that obesity is not the only risk factor for type 2 diabetes. Both obesity and type 2 diabetes are multifactorial complex diseases that are caused by a combination of genetic, environmental, and lifestyle factors. Results from twin studies suggest that genetic factors explain 50% to 90% of the variance in body mass index (BMI) and from 45% to 85% of the diabetes risk. However genetic variations identified by genome wide association studies (GWAS) explain only 2-4% of the obesity risk and 5-10% of the type 2 diabetes risk. Several options have been debated to be a source of so called “missing heritability”, including, among others, structural DNA variations, gene-gene and gene-environment interactions, epigenetic modifications and RNA splicing.
We used adipose tissue samples from Kuopio Obesity Surgery (KOBS), very low calorie diet (VLCD), Metabolic Syndrome in Men (METSIM) and European Network on Functional Genomics of Type 2 Diabetes (EUGENE2) studies to determine alternative splicing pattern of selected genes.
The study focused on determining the effects of obesity and weight loss on alternative splicing of metabolically active genes (TCF7L2 and INSR). We showed that alternative splicing of both genes is dysregulated in obesity and type 2 diabetes, resulting in impaired insulin action in adipose tissue. Additionally we demonstrated, that obesity induced changes in splicing can be reversed by weight loss induced by gastric bypass surgery or very low calorie diet.
Furthermore, the study identified alternatively spliced genes in the genomic regions associated with obesity risk, demonstrating that splicing of the MSH5 gene in subcutaneous fat is regulated by weight loss. The study also found that body mass index is a main determinant of TRA2B, BAG6 and MSH5 splicing in subcutaneous fat; however, the functional consequences of this finding require further investigation. These findings imply that the obesity-associated gene variants might act through regulation of splicing which in turn might underlie the pathogenesis of obesity in individuals carrying the risk variants.
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MedicalResearch.com Interview with: Mr Matthew Nankivell
MRC Clinical Trials Unit at University College London
Institute of Clinical Trials and Methodology
Aviation House, London
UK
Medical Research: What is the background for this study? What are the main findings?
Response: Ovarian cancer is diagnosed in over 7000 women each year in the UK. Over 75% of these already have advanced disease, for which the standard treatment is surgery followed by platinum based chemotherapy. The prognosis for these patients remains poor however, with less than 25% surviving for 5 years. There is consistent evidence that achieving optimal debulking (meaning less than 1cm of residual tumour after surgery) is key to increasing survival. The theory tested in Chorus is that giving the chemotherapy before surgery (neo-adjuvantly) would be as least as effective as giving it post-operatively, and may in fact increase the chance of achieving optimal debulking, and subsequently living for longer.
In Chorus we randomised 552 women to receiving either the current standard of immediate surgery followed by chemotherapy, or chemotherapy followed by surgery. The trial met its primary aim of showing that neo-adjuvant chemotherapy was no worse than post-operative chemotherapy, with median survival times of 24.1 and 22.6 months respectively. The proportion of women achieving optimal debulking increased from 41% in the post-operative chemotherapy group to 73% in the neo-adjuvant chemotherapy group. Additionally we saw that fewer women experienced serious post-operative complications having had neo-adjuvant chemotherapy (14% vs 24%), and fewer women died within 28 days of surgery (<1% vs 6%).
There is a planned meta-analysis, to combine the data from Chorus with those from a similar European trial, which will allow further investigations to take place, and may allow the identification of groups of women who are more likely to benefit from one or other of the approaches.
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MedicalResearch.com Interview with:
Jasmine Lee, M.Sc. and Chris I. Ardern, Ph.D.
School of Kinesiology and Health Science
York University
Toronto, ON, Canada
Medical Research: What is the background for this study?
Response: Although the benefits of physical activity are well known, the health and mortality risks associated with sedentary time (activities <1.5 MET)—which can occur in long, continuous bouts, such as at the workplace, during motorized transportation and via screen time— have been less frequently explored, and may differ across subgroups of the population. Like physical activity, sedentary time may fluctuate with major life events and occupation (e.g. aging, retirement, etc.), which raises the question of the short-term relationship between changes in sitting time and mortality risk.
Medical Research: What are the main findings?
Response: Maintenance of minimal sedentary time, as well as short-term reduction in sedentary time, were found to reduce the risk of all-cause and cancer- mortality amongst a sample of middle-aged and older women (50-79 y) who are prone to high rates of physical inactivity and sedentary time.
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MedicalResearch.com Interview with:
Katherine Jones, M.A.
Research Associate, Department of Research
The American College of Obstetricians and Gynecologists
Department of Psychology, American University
Medical Research: What is the background for this study? What are the main findings?
Response: It is well evidenced that breastfeeding is highly advantageous for the mother, child, and society. Benefits to breastfeeding may be significantly larger for minority women as they are disproportionately affected by numerous adverse health outcomes. The benefits of breastfeeding may help mitigate some of these negative health consequences, and thus, also bridge larger gaps in racial and ethnic health disparities. This article aimed to review the literature on racial and ethnic disparities in breastfeeding rates and practices, conduct a systematic review of breastfeeding interventions, address barriers to breastfeeding among minority women, and provide obstetrician-gynecologists (ob-gyns) with recommendations on how they can help improve rates among minority women.
Overall, racial and ethnic minority women continue to have lower breastfeeding rates than white women in the United States, with African American women having the lowest rates of breastfeeding initiation and continuation among to all women. Minority women report several unique barriers to breastfeeding, including lack of access to information that promotes and supports breastfeeding, lack of work and cultural acceptance and support, language and literacy barriers, acculturation, and historical, sociopolitical, and economic challenges. Results from the systematic review of breastfeeding interventions among minority women indicated that breastfeeding-specific clinic appointments, enhanced breastfeeding programs, group prenatal education, peer counseling, and hospital policy changes significantly improve breastfeeding initiation, duration, and exclusivity. (more…)
MedicalResearch.com Interview with:
Dr. Jeanne Tie
Medical Oncologist | Royal Melbourne and Western Hospital
Research Fellow
Walter and Eliza Hall Institute of Medical Research
Parkville, VIC
Medical Research: What is the background for this study?
Dr. Tie: The increasing number of active agents available to treat metastatic colorectal cancer has resulted in an ever-improving life expectancy in this group of patients. However, the ability to expose patients with metastatic colorectal cancer to all effective anti-cancer treatment, particularly 3rd line treatment and beyond, is increasingly challenging in routine practice as some patients’ condition deteriorate too rapidly and do not live long enough to enjoy the benefit of these additional therapies. This is partly due to the current imaged-based method of assessing treatment response with the Response Evaluation Criteria in Solid Tumors (RECIST), which is usually performed every 8-12 weeks during the course of treatment. This means that for non-responders to treatment, several weeks to months will elapse before a switch to alternative therapy will be made. Conceptually, if a patient’s response to treatment could be made earlier, such as with a blood test, then an earlier switch to an alternative treatment can be made, minimizing the side-effects of the ineffective therapy and providing the opportunity for a more effective one. Currently, blood biomarkers add little to imaging-based assessment, with CEA lacking sensitivity and specificity.
Colorectal cancer is characterised by several recurrently mutated genes and advances in genomics and molecular technologies have now enabled rapid detection and quantification of these cancer-specific mutations in patient’s circulation (circulating tumor DNA - ctDNA). Previous studies have demonstrated that ctDNA can be detected in a high proportion of patients with advanced cancer. In this study, we describe the potential role of ctDNA as an early predictor of treatment response in patients with treatment naïve metastatic colorectal cancer (mCRC) undergoing chemotherapy and as a marker of disease bulk that could complement RECIST measurement. (more…)
MedicalResearch.com Interview with:Perry N Halkitis, Ph.D., M.S., MPH
Professor of Applied Psychology
Global Public Health, and Population Health/Medicine
New York University.
Medical Research: What is the background for this study?
Dr. Halkitis: The P18 Cohort Study is a prospective cohort study of gay, bisexual and other young men who have sex with men (YMSM) which seeks to examine the development of health behaviors as these young men transition from adolescent to adulthood. Officially named “Syndemic Production among Emergent Adult Men”, this study was funded by the National Institute on Drug Abuse from 2009-2014 and renewed on March 1, 2014 for an additional five years.
The original aims of the study were as follows:
1) to develop and test theoretically informed measurement models of the covariance of illicit drug use, unprotected sexual behavior and mental health burden (multiple overlapping epidemics known as a syndemic) among emergent adult HIV-negative YMSM within and across time;
2) to delineate the risk and protective bases- physical factors (e.g., pubertal onset, HIV status, etc.), relational and structural factors (e.g., family history of psychopathology, current romantic relationships, peer support, neighborhood factors, etc.), and psychosocial factors (e.g., sexual identity, internalized homophobia, hyper-masculine conceptions, etc.) that predict the development of syndemics; and
3) to determine the extent to which the development of a syndemic varies by race/ethnicity, social class, and homelessness/housing instability.
In this current five year continuation we also seek
1) to describe the social and sexual networks of YMSM, and to examine the relationship between social and sexual network-level structural characteristics, social support and normative influences on syndemic production (illicit drug use, unprotected sexual behaviors, and mental health burden) in YMSM, singly and in combination with the physical, psychosocial, and relational predictors, both within and across time;
2) to describe the acquisition of sexually transmitted infections (STIs) in YMSM, specifically, urethral and rectal gonorrhea and chlamydia, pharyngeal gonorrhea as well as syphilis serology; and to determine the extent to which physical, relational, and psychosocial factors explain STI acquisition as part of the syndemic model within and across time.
A third exploratory aim was also added: 3) to describe HIV clinical treatment markers (i.e., HIV viral load, ART uptake and adherence, HIV care) among HIV+ YMSM, and to assess the extent to which physical, relational, and psychosocial factors are associated with differences in these clinical markers among HIV+ YMSM, both within and across time. The study is led by Drs. Perry N Halkitis and Farzana Kapadia at New York University’s Center for Health, Identity, Behavior & Prevention Studies.
Potential participants were recruited through both active (e.g., approaching individuals to solicit study participation) and passive (e.g., flyer posting, website advertisements) methods from June 2009 to May 2011. Eligibility criteria included being 18-19 years old, biologically male, residing in the NYC metropolitan area, having sex (any physical contact that could lead to orgasm) with a man in the last 6 months, and reporting a seronegative or unknown HIV status at baseline. We ensured the diversity of our sample by setting a fixed recruitment quota for participants in each targeted racial/ethnic group, such that African Americans, Latino (across race), Asian-Pacific Islander (API), and mixed race men comprised the majority of the sample. All participants provided written, informed consent before data was collected and were compensated for their time and effort upon completing the baseline assessment. The New York University’s Institutional Review Board (IRB) approved all study protocols and a federal Certificate of Confidentiality protects these data.
A total of 2,068 participants were screened for eligibility to participate in the study, and 600 participants completed the baseline assessment in the first wave of the study. In 2014, we began the second wave and opened to cohort to recruit a baseline sample of 650 YMSM who will now be between the ages of 22-23; recruitment of participants is still underway.
Medical Research: What are the main findings?
Dr. Halkitis: Numerous publications have been generated from the P18 Cohort Study and can be accessed at www.chibps.org. A recent publication, “Incidence of HIV infection in Young Gay, Bisexual, and other YMSM: The P18 Cohort Study” became available in the May 2015 of JAIDS, the Journal of Acquired Immune Deficiency Syndromes. This paper reports that over a 36 month follow-up period, during the first wave of the study, 7.2% of study participants seroconverted, with Black and Hispanic men much more likely to seroconvert over this time frame than White men. This finding aligns with epidemiological trends for HIV infection at the national and local, NYC, levels. Also, men reporting a lower familial socioeconomic status were more likely to seroconvert than men reporting high familial socioeconomic status, and Black men were more likely to report a lower socioeconomic status. Moreover, the Black young men who seroconverted were more likely to reside in neighborhoods with higher area-level poverty and higher area-level HIV prevalence. Additionally we found that men who reported anal sex without a condom in the 30 days prior to assessment were no more likely to seroconvert than those who reported sex with a condom. However, an earlier age of sexual debut was a predictor of HIV seroconversion.
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MedicalResearch.com Interview with:
Michelle Schmiegelow, MD, PhD-student
Hjertemedicinsk Forskning
Gentofte Universitetshospital
Hellerup
Medical Research: What is the background for this study?
Dr. Schmiegelow: Obesity has become a worldwide epidemic, but the excess cardiovascular risk observed in obese individuals may primarily be attributable to metabolic mediators, rather than obesity per se. Several studies conducted in primarily non-Hispanic white populations suggest that obese individuals without the metabolic syndrome, defined as metabolically healthy obese, have a cardiovascular risk similar to that of normal weight metabolically healthy individuals.
We used prospectively collected data from the Women’s Health Initiative studies to evaluate whether obesity unaccompanied by metabolic abnormalities was associated with increased risk of cardiovascular disease (CVD) across racial/ethnic subgroups in postmenopausal women. Additionally, we examined whether the use of the metabolic syndrome to define the metabolically healthy obese applied to the various racial/ethnic subgroups by quantifying the number and type of metabolic syndrome components.
All women were classified by obesity level and metabolic health status at baseline. The women were thus categorized according to body mass index (BMI, kg/m2) into normal weight (BMI 18.5-24.9 kg/m2), overweight (25-29.9 kg/m2) and obese (30.0 kg/m2) women. Metabolic health status was first defined by presence of the metabolic syndrome (yes/no), and second by number of metabolic syndrome components. In accordance with the International Diabetes Federation and the American Heart Association/National Heart, Lung, and Blood Institute we defined the metabolic syndrome as any two of the following (criteria for women): increased waist circumference ≥80 cm; increased level of triglycerides ≥150 mg/dL (≥1.7 mM); decreased level of HDL-C <50 mg/dL (<1.3 mM); increased blood pressure with either systolic blood pressure ≥130 mmHg or diastolic blood pressure ≥85 mmHg, or treatment with antihypertensive drugs; and impaired fasting serum glucose ≥100 mg/dL (6.1 mM).
Medical Research: What are the main findings?Dr. Schmiegelow: The study population comprised 14,364 women without diabetes or prior cardiovascular disease. The women had a median age of 64 years (interquartile range 57–69), and 47% were white, 36% were black and 18% were Hispanic. Over a median follow-up of 13 years (interquartile range 12–14 years), 1,101 women (7.7%) had a first cardiovascular event.
The main findings of this study were that metabolic abnormalities appeared to confer more cardiovascular risk among black women than among white women. Consistent with other studies, among white women without the metabolic syndrome, obesity was not associated with increased cardiovascular risk compared with normal weight women. Conversely, black overweight and black obese women had increased cardiovascular risk compared with normal weight black women without the metabolic syndrome, even in absence of the metabolic syndrome.
According to number of metabolic syndrome components, black overweight or obese women with just two metabolic abnormalities had increased risk of cardiovascular disease, although they would be considered “metabolically healthy” based on the standard definition, particularly since one of these abnormalities were abdominal obesity for 79% of overweight and 98% of obese women, irrespective of race/ethnicity. White obese women with three metabolic abnormalities did not have a statistically significantly increased cardiovascular risk compared with normal weight metabolically healthy women. Thus, cardiovascular disease risk appeared to be elevated in black women by the presence of only two or three metabolic abnormalities to a degree that would require four or more metabolic abnormalities among white women. These findings did not appear to be driven by any particular combination of metabolic abnormalities.
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MedicalResearch.com Interview with:
Dr. Hope M. Tiesman MSPH, PhD
CDC, AtlantaMedical Research: What is the background for this study? What are the main findings?Dr. Tiesman: The authors regularly monitor non-occupational injury trends, including the recent and significant increase in suicide rates. This finding led the authors to consider how these non-occupational trends impacted the workplace. We used data for two large national surveillance systems. We obtained data on workplace suicides from the Bureau of Labor Statistics' Census of Fatal Occupational Injury (CFOI) which compiles data on all fatal work-related injuries in the US. We obtained data on non-workplace suicides from the CDC's Web-Based Injury Statistics Query and Reporting System or WISQARS. WISQARS data are compiled using national death certificate data. From here we calculated suicide rates and compared trends across workplace and non-workplace suicides as well as examined the socio-demographics and occupational characteristics of those who chose suicide in the workplace.
Several important findings to highlight. Across the 8-yr timeframe, we found that workplace suicide rates remained relatively stable, even somewhat decreasing that it is until 2007 when a large and significant jump in rates was found. This was in contrast with non-workplace suicide rates which increased over the entire study period. Men had signifıcantly higher workplace suicide rates compared to women and generally, as age increased, so did workplace suicide rates. Those aged between 65 and 74 years had the highest suicide rate of all workers which was also a bit different from non-workplace suicide rates. Finally, we found that those in protective service occupations, such as police and firefighters, had the highest workplace suicide rates, followed closely by those in farming/fishing/and forestry occupations. These occupations have been associated with higher overall suicide rates in prior studies. A somewhat novel finding was that those in automotive maintenance and repair occupations also had significantly higher workplace suicide rates. (more…)
MedicalResearch.com Interview with:
David F. Penson, MD, MPH
Hamilton and Howd Chair in Urologic Oncology
Professor and Chair, Department of Urologic Surgery
Director, Center for Surgical Quality and Outcomes Research
Vanderbilt University Medical Center
Nashville, TN 37232-2765
Medical Research: What is the background for this editorial? What are the main findings?
Response: This editorial discusses the implication of the recent removal of the PSA data from the seer-medicare dataset. It reviews the significance of the action: specifically what it means for prior publications that used this information to address clinical research questions in prostate cancer. It makes the point that, while these datasets are powerful, researchers have stretched the limits of what they can do too far. Simply put, we cant always guarantee that the clinical data collected in administrative datasets will necessarily be accurate so we need to be more selective in how we use these data and not simply run analyses on the data just because it is easy.
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MedicalResearch.com Interview with:
Thomas M. Gill, M.DHumana Foundation Professor of Medicine (Geriatrics)
Professor of Epidemiology and of Investigative Medicine
Director Yale Program on Aging and Yale Center for Disability and Disabling Disorders
Director, Yale Training Program in Geriatric Clinical Epidemiology and Aging-Related Research
Medical Research: What is the background for this study? What are the main findings?h
Response: Understanding the disabling process at the end of life is essential for informed decision-making among older persons, their families, and their physicians.
We know from prior research that the course of disability at the end of life does not follow a predictable pattern for most older persons. This raises the question about what is driving the development and progression of disability at the end of life.
We identified six distinct trajectories of disability in the last year of life, ranging from the least disabled to most disabled. We found that the course of disability in the last year of life closely tracked the monthly prevalence of hospitalization for each of the six trajectories.
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Medicalresearch.com Interview with:
Ross Anderson M.D.,M.C.R.
Allina Health clinics and
Jim Hotaling M.D.,M.S.,F.E.C.S.M.
Utah Center for Reproductive Medicine
Salt Lake City, UT 84108MedicalResearch: What is the background for this study? What are the main findings?Dr. Anderson: There is a growing trend of delayed marriage and childbearing, particularly into the third and fourth decade of life. Advanced maternal age is well recognized as a risk factor for chromosomal abnormalities and perinatal complications, but there is also growing interest in the impact of advanced paternal age.
Multiple studies have demonstrated that as men age their sperm quality and ability to have children decreases. We were interested in how the age of the parents and the age of the grandparents at the time of conception can affect a man’s sperm quality. We hypothesized that men with older parents and grandparents at the time of conception would have a linear decrease in the quality of their sperm.
We used Utah’s two largest andrology lab’s semen analyses and these men were linked to the Utah Population Database. The Utah Population Database allows us access to birth certificate data and pedigree data going back to the late 1800s. With this we can determine the age of the parents and grandparents at the time they had each subsequent generation.
We found that the age of the parents did not influence a man’s semen concentration, motility, or total sperm count. Interestingly, the age of the paternal grandfather was associated with an increased risk of poor semen concentration. For instance, if a grandfather was older than 45 year of age at the time of conception of the father, there is a 39% chance a man’s semen concentration would be considered low according to the World Health Organization (less than 15 million per milliliter). (more…)
MedicalResearch.com Interview with:
Wendong Li, Ph.D.
Assistant professor of psychological sciencesDepartment of Psychological Sciences
Kansas State University
Manhattan, KS
Medical Research: What is the background for this study? What are the main findings?Dr. Wen-Dong Li: There has been a "nature versus nurture" debate in leadership: Are leaders born or made? In academia, research on trait theories of leadership has shown that important individual characteristics such as personality traits are predictive of whether one is a leader or not (leadership role occupancy or emergence). One author of this paper, Dr. Arvey conducted twin studies showing that about 30% of the individual differences in leadership is attributable to individual differences in their genetic makeup. But so far, little research has examined whether specific genes are involved and no research has examined the pathways linking genes to leadership.
This is where this research came in. We found that a dopamine transporter gene, DAT1 was involved in genetic influences on leadership role occupancy, but through two opposing pathways. One pathway is through proactive personality: DAT1 10-repeat allele was negatively related to proactive personality, which in turn was positively associated with leadership role occupancy. The negative indirect effect was significant. On the other hand, DAT1 was positively related to (moderate) rule breaking, which was positively associated with leadership role occupancy. The overall relationship between DAT1 and leadership was not significant. Thus we call it a mixed blessing because the two opposing mechanisms offset each other.
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MedicalResearch.com Interview with:Rik Ossenkoppele PhD.
Postdoctoral researcher
UCSF Memory and Aging Center
MedicalResearch: What is the background for this study? Dr. Ossenkoppele: Since 2004, several PET tracers have been developed that measure fibrillar amyloid-β plaques, a neuropathological hallmark of Alzheimer’s disease (AD). Through visual assessment by a nuclear medicine physician or quantitative cut-points, the presence or absence of amyloid-β pathology can be determined in the living human brain. The FDA, in support of the clinical application of amyloid imaging, has recently approved three of these PET tracers. A proportion of patients with other types of dementia then Alzheimer’s disease that harbor cerebral amyloid-β pathology, however, potentially limits the clinical utility of amyloid imaging. When ordering clinical amyloid PET scans and correctly interpreting the significance of amyloid PET results, clinicians need to understand the prevalence of amyloid-positivity across different types of dementia. It is also important to be aware of the relationships of amyloid-positivity prevalence and demographic (e.g. age and sex), cognitive and genetic (e.g. presence of the AD-risk allele apolipoprotein E [APOE] ε4) factors. Most amyloid PET studies to date come from single centers with modest sample sizes. We therefore conducted a meta-analysis with individual participant data from 29 cohorts worldwide, including 1359 patients with clinically diagnosed Alzheimer’s disease and 538 patients with non-AD dementia. We also included 1849 healthy controls with amyloid PET data, and an independent sample of 1369 AD patients with autopsy data from the NACC database.
MedicalResearch: What are the main findings?Dr. Ossenkoppele: In patients clinically diagnosed with Alzheimer’s disease, the prevalence of amyloid-positivity decreased from 93% at age 50 to 79% at age 90. The drop in amyloid-positivity was most prominent in older Alzheimer’s disease patients who did not carry an APOE ε4 allele (~1/3 of these patients had a negative amyloid PET scan). This most likely reflects a mix of
1) clinical misdiagnoses (i.e. non-AD pathology causing an AD phenotype),
2) false negative PET scans (i.e. abundance of cerebral amyloid pathology that is not detected by PET), and
3) possibly elder patients need less amyloid pathology (sub-threshold levels for PET) to reach the stage of dementia due to age-related reductions in cognitive resilience (“cognitive reserve theory”) or simultaneous presence of multiple pathologies (“double-hit theory”).
The relatively high rate of amyloid-negative Alzheimer’s disease patients highlights the necessity of biomarker-informed patient selection for Alzheimer’s disease clinical trials.
In most patients clinically diagnosed with non-AD, the prevalence of amyloid-positivity increased with aging and was ~18% higher in APOE ε4 carriers. Presence of amyloid pathology in non-AD dementia may reflect
1) clinical misdiagnosis (i.e. AD pathology is the causative pathology), or
2) comorbid pathologies, where amyloid may be secondary to other pathologies that are actually driving the clinical presentation. Interestingly, patients with a clinical diagnosis of non-AD dementia who harbored cerebral amyloid pathology showed lower Mini-Mental State Examination scores (measure of global cognition), suggesting that amyloid-β is not just an innocent bystander.
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MedicalResearch.com Interview with:
Robert Wong, M.D., M.S.
Attending Physician, Gastroenterology & Hepatology
Director, GI Research
Highland Hospital I A member of Alameda Health System
Oakland, CA 94602
Medical Research: What is the background for this study? What are the main findings?
Dr. Wong: The main findings are that despite the stabilizing prevalence of metabolic syndrome, a large proportion of U.S. adults affected with metabolic still raises concern, especially given the significant health consequences associated with this syndrome. In additional to cardiovascular disease, metabolic syndrome also increases the risk of concurrent nonalcoholic fatty liver disease, often considered the hepatic manifestation of metabolic syndrome. Many studies, including work that our group has completed suggests that nonalcoholic fatty liver disease will soon become the leading etiology of chronic liver disease in the U.S. Furthermore, our finding that metabolic syndrome increases with increasing age, reflects the increased risk for metabolic syndrome associated diseases such as hypertension, diabetes, and dyslipidemia with older age. This is important to recognize given the aging population of the U.S.
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MedicalResearch.com Interview with:
Jeff Bridge, Ph.D
Center for Innovation in Pediatric Practice
Principal InvestigatorThe Research Institute at Nationwide Children's Hospital
Medical Research: What is the background for this study?
Dr. Bridge: Suicide is a leading cause of death among children younger than 12 years. Suicide rates in this age group have remained steady overall for the past 20 years, but this is the first national study to observe higher suicide rates among black children compared to white children. Little is known about the epidemiology of suicide in this age group, as prior research has typically excluded children younger than 10 years old and investigated trends only within specific older age groups.
Medical Research: What are the main findings?
Dr. Bridge: We found that suicide ranked 14th as a cause of death among 5- to 11-year old black children in 1993-97 but rose to 9th in 2008-12. For white children, suicide ranked 12th in 1993-97 and 11th in 2008-12. Rates have remained stable in Hispanic and non-Hispanic children. The findings in this study highlight an emerging racial disparity in the epidemiology of childhood suicide.
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MedicalResearch.com Interview with:
Josep Rodés-Cabau MD
Quebec Heart and Lung Institute,
Quebec City, QC, Canada
Medical Research: What is the background for this study? What are the main findings?Dr. Rodés-Cabau: Hemolysis is the breakdown of red blood cells (RBC) in the body. There are many different causes of hemolysis, however a common cause is when RBCs traverse foreign substances, such as inserted heart valve prostheses. The biological interaction between the RBC and a foreign substance may cause RBC lysis/destruction. Furthermore, in the setting of turbulent blood flow, such as when a prosthetic heart valve is starting to leak, the degree of hemolysis could reflect the severity and duration of this leak. In the absence of valve leaks, hemolysis rates and severity may simply reflect how biocompatible a foreign/prosthetic valve is within the body. The lower the hemolysis rate and severity, the more biocompatible the valve/foreign body.
There are many different brands and generations of prosthetic heart valves that have been implanted in humans during the prior decades. The early-generation surgically implanted valves caused quite severe hemolysis requiring re-operation when possible. Modern-day surgical heart valves now have superior designs and rarely cause significant hemolysis. Nevertheless the rates of sub-clinical (or biochemical) hemolysis are around 30% for modern-day mechanical heart valves.
Nowadays, certain patients are eligible to undergo transcatheter aortic valve implantation (TAVI), a revolutionary means of valve replacement without the need for open heart surgery. However to-date, the biocompatibility of these new transcatheter heart valves has not been tested in humans in vivo. We systematically evaluated hemolysis rates and its associated factors in a large consecutive series of patients undergoing TAVI at the Quebec Heart & Lung Institute, Quebec, Canada.
We found that the rate of transcatheter heart valve hemolysis was 15%, lower than that reported for modern-day mechanical surgically implanted valves. No patient demonstrated severe hemolysis. The presence of a size mismatch between the patient and transcatheter valve (termed prosthesis patient mismatch) significantly associated with the likelihood of hemolysis. Indirect measurements of wall shear stress also associated with hemolysis rates.
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MedicalResearch.com Interview with:
Dr. Michael Bailey, Ph.D.
Senior Principal Engineer
Assistant Professor, Mechanical Engineering
and Adjunct Assistant Professor, Urology
University of Washington
Medical Research: What is the background for this study? What are the main findings?
Dr. Bailey: Ultrasonic propulsion is a new technology that uses focused ultrasound energy to reposition kidney stones transcutaneously. We report the findings from the first human investigational trial of ultrasonic propulsion toward the applications of expelling small stones and dislodging large obstructing stones. Subjects underwent ultrasonic propulsion either awake without sedation or during ureteroscopy while anesthetized. A pain questionnaire was completed before, during, and after propulsion for awake subjects. Potential adverse events were assessed weekly for 3 weeks after propulsion for all subjects.
The primary outcome was to reposition stones in the collecting system. Secondary outcomes included safety, controlled movement of stones, and movement of stones < 5 mm and ≥ 5 mm. Stones were localized and repositioned in 14 of 15 enrolled subjects. Of the 43 targets, 28 (65%) showed some level of movement while 13 (30%) were displaced to a new location > 3 mm. No adverse events were reported. Mild discomfort during the procedure was rare, brief, and self-limited. Stones were moved in a controlled direction with over 30 fragments being passed by most patients who previously had a lithotripsy procedure. The largest stone moved was 10 mm. One patient experienced pain relief during treatment of an obstructing stone. In 4 subjects a seemingly large stone, which might have required surgery, was determined to be a cluster of small passable stones.
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