MedicalResearch.com Interview with: [caption id="attachment_22541" align="alignleft" width="200"] Dr. Robert Boyle[/caption] Dr. Robert J Boyle Pediatric Allergist Imperial College London MedicalResearch.com: What is the background for this...
Dr. Changhai Ding[/caption]
Changhai Ding, MBBS, MMED, MD
Australian Research Council Future Fellow
Associate Director (International), Menzies Institute for Medical Research
Professor, University of Tasmania, Australia
Honorary Professor, University of Sydney, Australia
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Ding: Vitamin D can reduce bone turnover and cartilage degradation, thus potentially preventing the development and progression of knee osteoarthritis. Observational studies suggest that vitamin D supplementation is associated with benefits for knee osteoarthritis, but current evidence from clinical trials is contradictory.
We conducted a randomised clinical trial in Hobart, Tasmania and Melbourne, Victoria in Australia. We randomly assigned 413 patients with symptomatic knee osteoarthritis and low 25-hydroxyvitamin D to receive monthly treatment with oral vitamin D3 (50,000 IU; n = 209) or an identical placebo (n = 204) for 2 years.
Of 413 enrolled participants (average age, 63 years; 50 percent women), 340 (82 percent) completed the study. Vitamin D supplementation significantly increased blood 25-hydroxyvitamin D levels over 2 years compared with placebo treatment; however, vitamin D supplementation, compared with placebo, did not result in significant differences in change in MRI-measured tibial cartilage volume or a measure of knee pain over 2 years. There were also no significant differences in change of tibiofemoral cartilage defects or change in tibiofemoral bone marrow lesions.
Post-hoc analyses indicated that vitamin D supplementation might improve knee physical function and reduce another measure of knee pain and increases in bone marrow lesion.
Dr. Cathy Handy[/caption]
Cathy Handy, MD MPH
Fellow, Department of Oncology
Johns Hopkins Hospital
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Handy: We explored the relationship between coronary artery calcium and age related diseases. Coronary artery calcium refers to calcium deposits in the blood vessels of the heart. It can be seen with a non invasive imaging test and is thought to be a biologic measure of aging. Previous research has shown coronary artery calcium to be highly correlated with cardiovascular disease and mortality. We found that it is also associated with an increased risk of cancer, pneumonia, chronic kidney disease, chronic obstructive pulmonary disease and hip fractures.
Benedicte Kirkøen[/caption]
MedicalResearch.com Interview with:
Benedicte Kirkøen, PhD candidate
Bowel Cancer Screening in Norway – a pilot study
Cancer Registry of Norway (Kreftregisteret)
MedicalResearch.com: What is the background for this study?
Response: Randomised controlled trials have demonstrated that screening for colorectal cancer (CRC) can reduce CRC related mortality, but the total benefit and harm of national cancer screening programmes are under debate. Saving relatively few lives requires a large number of people to be screened. Most people who attend screening will never develop cancer, but may be exposed to potential psychological stress by participation. Cancer is one of the largest threats to peoples’ health, and participating in screening for cancer might therefore cause anxiety.
In Norway, colorectal cancer incidence has nearly tripled since the 1950s, and currently a large randomised pilot study of a national screening programme (Bowel Cancer Screening in Norway) is investigating the effect of screening on reduction in CRC incidence and mortality. As part of an evaluation of the benefits and harms of the pilot, we investigated the psychological effect of screening participation in a large group of participants. Of particular interest to us were participants who received a positive screening result and were referred to colonoscopy.
Dr. Robert Nam[/caption]
Robert Nam, MD, FRCSC
Ajmera Family Chair in Urologic Oncology
Professor of Surgery
University of Toronto
Head, Genitourinary Cancer Site
Odette Cancer Centre
Sunnybrook Health Sciences Centre
Toronto, Ontario
MedicalResearch.com: What is the background for this study?
Response: Prostate cancer treatment is associated with a number of complications including erectile dysfunction and urinary incontinence. Two years ago, we published a paper examining other, previously undescribed complications. The most controversial finding was a significantly increased risk of secondary cancers among men treated with radiotherapy. We therefore wanted to assess this in a meta-analysis, examining all the research currently available on the topic.
MedicalResearch.com: What are the main findings?
Response: We found that, for patients with prostate cancer, radiotherapy treatment was associated with significantly increased rates of bladder cancer, colorectal cancer and rectal cancer. There wasn't an increased risk for other cancers such as lung and blood system cancer. However, the absolute rates of these cancers remained low (1-4% of patients).
Dr.Alison Culyba[/caption]
Alison Culyba, MD MPH
Adolescent Medicine Advanced Research Fellow
Craig-Dalsimer Division of Adolescent Medicine
Children’s Hospital of Philadelphia
PhD Candidate, Epidemiology
Department of Epidemiology and Biostatistics
Perelman School of Medicine at the University of Pennsylvania
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Culyba: Youth violence is a major public health problem. Homicide is the second leading cause of death among all adolescents in the U.S., and the number one cause of death among African American adolescents. Prom prior research, we know that where you live and where you spend time has a major impact on health, and that making changes to environments, such as greening vacant lots and remediating abandoned buildings, can significantly reduce crime. However, much less is known about the relationship between adolescent’s immediate surroundings and the risk of homicide. The goal of this study was to examine associations between neighborhood environmental features, such as streets, buildings, and natural surroundings and adolescent homicide. We conducted a population-based case control study of 143 adolescents, ages 13 to 20, who were victims of homicides in Philadelphia and 155 matched controls in the same range, who were outdoors in Philadelphia at the same time that the homicides occurred. To assess features in the immediate environments of homicide victims and control individuals, trained field staff stood on the street corner of each homicide and control location and took a series of photographs that we stitched together into 360-degree high resolution panoramas, which we assessed for environmental features. After accounting for many individual and neighborhood contextual factors, we found that the odds of homicide was significantly lower in locations with street lighting, pedestrian infrastructure, public transportation, parks, and maintained vacant lots.
Dr. Agnes Dechartres[/caption]
Dr. Agnes Dechartres MD, PhD
Centre de Recherche Epidémiologie et Statistique
Paris, France
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Dechartres: In general, the availability of trial results is not optimal, with about half of the results from clinical trials, especially those with negative results, not being published in journals. To improve the availability of results, the FDA Amendment Act (FDAAA) requires results to be posted at ClinicalTrials.gov for all trials evaluating FDA-approved drugs, devices, or biologics within one year of trial completion. However, some previous methodological studies showed poor compliance with this law1-3.
Rare diseases are defined by a prevalence of fewer than 200,000 people, but overall, they may affect up to 25 million people in North America. The limited number of patients affected by each rare disease makes this research particularly challenging, and the access to information on all trials conducted and their results is even more necessary.
In this study, we aimed to describe the characteristics of completed phase 3 or 4 trials of rare diseases registered at ClinicalTrials.gov and assess whether their results were publicly available.
We found a substantial proportion of single-group trials and trials not randomized. Many trials were also conducted in a single-center.
Concerning the availability of results, 36 months after trial completion, results were posted at ClinicalTrials.gov for 35% of trials, published in journals for 47%, and publicly available (ie, posted at ClinicalTrials.gov or published in journals) for 63%.
Among the trials likely subject to the FDAAA, 68% had results posted at ClinicalTrials.gov: 4% had results posted at 12 months and 57% at 36 months. We also found that 21% of studies not concerned by the FDAAA had results posted.
Dr. Andrew Auerbach[/caption]
Dr. Andrew Auerbach MD
Professor of Medicine in Residence
Director of Research Division of Hospital Medicine
UCSF and
[caption id="attachment_22367" align="alignleft" width="100"]
Dr. Jeffrey Scnhipper[/caption]
Jeffrey L. Schnipper, MD, MPH
Associate Physician, Brigham and Women's Hospital
Associate Professor of Medicine, Harvard Medical School
Department of Medicine
Brigham and Women's Hospital
MedicalResearch.com: What is the background for this study?
Response: The Affordable Care Act required the Department of Health and Human Services to establish a program to reduce what has been dubbed a “revolving door of re-hospitalizations.” Effective October 2012, 1 percent of every Medicare payment was deducted for a hospital that was determined to have excessive readmissions. This percentage has subsequently increased to up to 3 percent. Penalties apply to readmitted Medicare patients with some heart conditions, pneumonia, chronic lung disease, and hip and knee replacements.
Unfortunately, few data exist to guide us in determining how many readmissions are preventable, and in those cases how they might have been prevented.
MedicalResearch.com: What are the main findings?
Response: Our main findings were that 27 percent of readmissions were preventable, and that the most common contributors to readmission were being discharged too soon, poor coordination between inpatient and outpatient care providers, particularly in the Emergency Departments and in arranging post acute care.
Dr. Erin Marcotte[/caption]
Erin Marcotte, Ph.D.
Assistant Professor
Division of Epidemiology and Clinical Research
Department of Pediatrics
University of Minnesota
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Marcotte: Recently there have been several studies that indicate a higher risk of immune-related disorders, such as type-I diabetes, asthma, and allergies, among children born by cesarean delivery. Our analysis used pooled data from 13 independent studies of childhood leukemia that were conducted in 9 different countries. We used data on over 33,000 children to investigate the relationship between birth by cesarean delivery and risk of childhood leukemia. We did not find an association between cesarean delivery overall and childhood leukemia. However, when we looked at emergency cesarean deliveries and pre-labor (planned) cesarean deliveries separately, we found a 23% increase in risk of acute lymphoblastic leukemia among children born by pre-labor cesarean delivery.
Anna Hedström PhD student[/caption]
Anna Hedström PhD student
Karolinski Institute
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: Previous studies on the influence of coffee consumption on multiple sclerosis (MS) risk have yielded inconclusive results, perhaps largely due to statistical power problems since these studies comprised few cases. Caffeine consumption has a protective effect on neuroinflammation and demyelination in animal models of MS. We therefore aimed to investigate whether coffee consumption is associated with MS risk, using two large population-based case-control studies (a Swedish study comprising 1620 cases and 2788 controls, and a United States study comprising 1159 cases and 1172 controls).
The risk of multiple sclerosis was reduced by approximately 30% among those who reported a high coffee consumption, around six cups daily, compared to those who reported no coffee consumption. The risk of multiple sclerosis decreased with increasing coffee consumption. Potentially important influential factors were taken into consideration, such as smoking and adolescent obesity.
Dr. Hakan Ay[/caption]
Hakan Ay MD, FAHA
Associate Professor of Neurology and Radiology
Stroke Service, Department of Neurology
Director of Stroke Research,
A.A. Martinos Center, Department of Radiology
Massachusetts General Hospital
Harvard Medical School
Boston MA, USA
Medical Research: What is the background for this study? What are the main findings?
Dr. Ay: Recurrent stroke is an important public health problem. One quarter of all strokes are recurrent strokes. Approximately one out of every 10 patients with stroke develops a second stroke within the next 2 years. The most critical period for recurrence after stroke is the first 90 days; approximately half of recurrent strokes that occur within 2 years occur within the first 90 days. The RRE tool was developed at the Massachusetts General Hospital in 2010 to assess the 90-day risk of recurrent stroke. The RRE was subsequently tested in a separate cohort of patients with transient stroke symptoms (mini strokes) admitted to the Massachusetts General Hospital in 2011. The current study expands upon prior two studies by showing that the RRE tool provides reliable risk estimates when tested in cohorts of patients recruited from different academic centers in various parts of the world. The study reports that the RRE can stratify approximately one-half of patients with stroke either at high-risk or at low-risk with a reasonable accuracy.
Dr. Thomas Pilgrim[/caption]
Thomas Pilgrim, Prof. Dr. med.
Oberarzt, Invasive Kardiologie
Universitätsspital Bern
Bern Switzerland
MedicalResearch.com: What is the background for this study?
Dr. Pilgrim: Three quarters of all children worldwide grow up in regions endemic for rheumatic heart disease. Clinically manifest rheumatic heart disease represents only the tip of the iceberg: only one in in 5 to 8 children with valvular lesions consistent with rheumatic heart disease have a heart murmur or clinical symptoms; the remaining children have clinically silent disease that goes undetected unless echocardiography is performed. An understanding of incidence, prevalence, and progression of disease is an important prerequisite to guide active surveillance and secondary prevention. We therefore performed a school-based cross-sectional study among more than 5000 children from 26 schools in Nepal. The objective of the study was to assess prevalence of clinically silent and manifest rheumatic heart disease as a function of age, gender and socioeconomic status and to estimate the age-specific incidence from available prevalence data.
MedicalResearch.com: What are the main findings?
Dr. Pilgrim: In our population-based observational cross-sectional study, the prevalence of borderline or definite rheumatic heart disease among schoolchildren in Eastern Nepal amounted to 10.2 (95% CI 7.5-13.0) per 1000 children between the ages of 5 and 15 years, and was more common in girls as compared to boys. The prevalence increased across age categories in a nearly linear fashion from 5.5 (95% CI 3.5-7.5) per 1000 in children 5 years of age to 16.0 (95% CI 14.9-17.0) in children 15 years of age, while the average incidence remained stable at 1.1 per 1000 children per year. The prevalence of clinically silent rheumatic heart disease was 5 times higher compared to manifest disease and the ratio of manifest to subclinical disease increased with increasing age.
Dr. Katherine Musliner[/caption]
Katherine L. Musliner, PhD
National Centre for Register-Based Research, Department of Economics and Business Economics, Aarhus University, Aarhus, Denmark
The Lundbeck Foundation Initiative for Integrative Psychiatric Research
Department of Mental Health
The Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: There is great variation among patients with depression in terms of long-term illness course. This variation may be indicative of underlying differences in the cause of the illness, and from a practical perspective, it also has implications for treatment and allocation of public health resources. Our goal was to identify different trajectories of depression course by examining inpatient and outpatient contacts for depression at psychiatric treatment facilities in Denmark (where healthcare is free) during the 10-year period following patients’ initial depression diagnosis.
We found that the majority of patients (77% in our sample) followed a trajectory characterized by a brief period of contact with the psychiatric treatment system and no contact for depression during the remainder of the 10-year follow up period. Patients with more prolonged contact either had a drawn out initial period of contact lasting as long as five years (13%), left depression treatment for several years only to return with a depression diagnosis years later (7%) or exhibited a chronic course (3%).
Dr. Massimo Cristofanilli[/caption]
Massimo Cristofanilli, MD, FACP
Professor of Medicine
Associate Director of Translational Research and Precision Medicine
Department of Medicine-Hematology and Oncology
Robert H Lurie Comprehensive Cancer Center
Feinberg School of Medicine
Chicago, IL 60611
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Cristofanilli: The majority of breast cancer are estrogen-receptor positive and therefore candidate for treatment with endocrine therapy in the adjuvant and advanced settings. The most significant issue in the management of estrogen-receptor positive metastatic breast cancer is the development of drug resistance. Very few effective options are available for patients that demonstrate progression of disease while on standard endocrine therapy, particularly in premenopausal women and/or women that have even progressed on chemotherapy. The study demonstrated that the combination of fulvestrant with palbociclib, a novel inhibitor of CDK4/6 kinases, significantly improve response to treatment and delays disease progression with minimal toxicity. 
Dr. Albert Siu[/caption]
Dr. Albert Siu M.D., M.S.P.H.
Chair of the U.S. Preventive Services Task Force
Chairman and professor of the Brookdale Department of Geriatrics and Palliative Medicine
Icahn School of Medicine at Mount Sinai
Director of the Geriatric Research, Education, and Clinical Center
James J. Peters Veterans Affairs Medical Center
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Siu: Impaired vision is a serious and common problem facing older adults and can affect their independence, ability to function, and quality of life. When the Task Force reviewed the research around screening older adults for vision impairment in a primary care setting, we concluded that the current evidence is insufficient to assess the balance of benefits and harms. As a result, we issued an I statement, which is consistent with the 2009 final and 2015 draft recommendations.
MedicalResearch.com: What should clinicians and patients take away from your report?
Dr. Siu: Older adults who are having problems seeing should talk to their primary care doctor or an eye specialist. Primary care doctors can explore the various causes of vision problems and do an eye exam to check for refractive error. An eye specialist can do a full eye exam to look for and treat refractive errors and other eye conditions that affect vision, such as cataracts and age-related macular degeneration (AMD). With regards to clinicians, in the absence of clear evidence, they should use their clinical judgment when deciding whether to screen patients who have not reported any concerns about their vision.
Dr. Oleg Gluz[/caption]
Oleg Gluz, MD
West German Study Group
Breast Center Niederrhein
Evangelical Hospital Bethesda
Moenchengladbach, Germany
MedicalResearch.com: What is the background for this study?
Dr. Gluz: PlanB trial is a Phase III chemotherapy study performed in patients with clinically high risk HER2 negative breast cancer. After early amendement, Recurrence Score (Oncotype Dx) as a selection criterion for or against chemotherapy together with central pathology review were included into the study. Patients with very low RS of below 12 and up to 3 positive lymph nodes were recommended to omit chemotherapy based on the low genomic recurrence risk. Chemotherapy was omitted in about 15% of all patients.
For the first time we present prospective data comparing a genomical tool (Oncotype Dx) and an independent central pathology review for grade, ER, PR, and Ki-67 from a large phase III study combined with an exploratory analysis on early relapse risk.
MedicalResearch.com: What are the main findings?
Dr. Gluz: The study has two major findings:
We have found a significant discordance in risk assessment between prognostic tools (grade by local and central lab, Oncotype Dx, Ki-67).
Patients treated by endocrine therapy alone based on very low Recurrence Score had an excellent disease free survival of 97% after 3 years of follow up.
Dr. David Hodgson[/caption]
David Hodgson, MD, MPH, FRCPC
Associate Professor
University of Toronto
Toronto, ON Canada
MedicalResearch.com: What is the background for this study?
Dr. Hodgson: We know that treatment for childhood Hodgkin lymphoma can cause some side effects that arise years after treatment is finished. In particular, radiotherapy given to the chest of adolescent females increases the risk of developing breast cancer in young adult survivors. But there are very little data about whether the early initiation of breast cancer screening will prevent breast cancer deaths in these survivors, and what kinds of screening is optimal. This is important because less than half of these young survivors are undergoing breast cancer screening, and in some jurisdictions early screening is not covered by insurance.
MedicalResearch.com: What are the main findings?
Dr. Hodgson: Because there has not been, and likely never will be, a large randomized screening trial for these patients, we used all the available information about their breast cancer risk, other health issues and the effectiveness of screening, and created a mathematical model that allows us to estimate the number of breast cancer deaths prevented by starting screening at age 25 for women who had received chest RT as teenagers. We found that one would have to invite about 260 survivors to early mammographic screening to prevent one breast cancer death, which compares favorably to other accepted reasons for breast cancer screening. Using MRI for screening, approximately 80 women would have to be invited to prevent one breast cancer death, because MRI is so much more sensitive than mammography. One of the problems with MRI, however, is that a substantial number of women will have "false positive" tests - abnormal findings that are not really cancer.