Hrishikesh Kale[/caption]
Hrishikesh Kale
School of Pharmacy
Virginia Commonwealth University
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: The cost of cancer care in the United States is extremely high and escalating every year. Because of increased cost sharing, patients are paying higher out-of-pocket costs for their treatments. Along with high medical expenses, cancer survivors face problems such as loss of employment and reduced productivity. It has been well-established in the literature that because of high out-of-pocket costs, many cancer survivors forgo or delay medical care and mental health-related services and avoid filling prescriptions. This puts their physical and mental health at risk.
A related issue is the growing number of cancer survivors in the U.S. As of January 2014, there were approximately 14.5 million cancer survivors in the U.S. By 2024, this number is expected to reach 19 million as a result of improved survival among patients with cancer along with an aging population. Therefore, we decided to investigate the prevalence and sources of financial problems reported by a nationally representative sample of cancer survivors from the 2011 Medical Expenditure Panel Survey. We also studied the impact of cancer-related financial burden on survivors’ health-related quality of life and psychological health.
Dr. Charles Lockwood[/caption]
Charles J. Lockwood, MD
Member of of the March of Dimes Board of Trustees
Dean at Morsani College of Medicine
Senior Vice President, USF Health and Professor of Obstetrics & Gynecology, and Public Health The University of South Florida
MedicalResearch.com: What is the background for this study? What are the main findings?
Dr. Lockwood: There remain questions about the utility of vaginal progesterone therapy in asymptomatic women with singleton gestations at risk for preterm birth. The OPPTIMUM study investigators conducted a double-blind, randomized, placebo-controlled trial of vaginal progesterone delivered via a pessary releasing 200 mg per day (n=618) vs. placebo (n=610) from around 22 to 34 weeks gestation among women at high risk for prematurity on the basis of a characteristic history and/or the presence of cervicovaginal fetal fibronectin or a cervical length less than 25 mm in length on transvaginal ultrasound. The primary endpoints were fetal death or preterm birth before 34 weeks (obstetrical outcome), or a composite of neonatal mortality or morbidities (neonatal outcome). The authors found that progesterone had no significant impact on either primary endpoint, with an adjusted OR of 0·86, 95% CI: 0·61-1·22 for obstetrical outcomes and an OR of 0·62, 95% CI:0·38-1·03 for neonatal outcomes.
Dr. Ronald Chamberlain[/caption]
Ronald S. Chamberlain, MD, MPA, FACS
Chairman and Surgeon-in-Chief
Department of Surgery
Saint Barnabas Medical Center
Professor of Surgery
New Jersey Medical School
Rutgers University
MedicalResearch.com: What is the background for this study?
Dr. Chamberlain: With the rapidly growing arthritic, aging, and obese population, total hip replacement (THR) has become the most commonly performed orthopedic procedure in the United States (US). The Affordable Care Act signed by President Barack Obama imposed financial penalties for excess readmissions following certain procedures and diagnoses. While the initial program aimed to reduce readmissions for heart failure, pneumonia, and acute myocardial infarction (AMI), the program expanded to include THR in 2015. With current research estimating a 10%, 30-day readmission rate following a total or partial hip replacement, this study sought to identify factors associated with readmission and to create a scale which could reliably stratify preoperative readmission risk.
Dr. Joseph Unger[/caption]
Joseph Unger, PhD, MS
SWOG Statistical Center
Assistant Member, Public Health Sciences Division, Fred Hutchinson Cancer Research Center
Affiliate Assistant Professor, Health Services Research, University of Washington
Seattle, WA 98109-1024
MedicalResearch.com: What is the background for this study?
Dr. Unger: The rate at which trials are positive has previously been examined, and the relationship between trial results and publication rates in the context of publication bias has also been studied. But the comparative scientific impact of positive vs negative clinical trials using citation data has not been investigated
We used the phase III trial database of SWOG, a major national cooperative clinical trials group, in combination with its trial publication database and citation data from Google Scholar, to compare the scientific impact of positive vs negative phase III cancer clinical treatment trials.
Dr. Gary Tearney[/caption]
Guillermo J. Tearney, MD PhD
Mike and Sue Hazard Family MGH Research Scholar
Professor of Pathology, Harvard Medical School
Wellman Center for Photomedicine
Massachusetts General Hospital
MedicalResearch.com: What is the background for this study?
Dr. Tearney: In this study, we investigated a new, advanced catheter-based imaging technology for identifying the coronary plaques that may potentially precipitate heart attack. The new technique combines intracoronary OCT, that provides images of tissue emicrostructure with near-infrared autofluorescence (NIRAF) that informs on the molecular/biological characteristics of plaque.
MedicalResearch.com: What are the main findings?
Dr. Tearney: Our main findings were that:
1) Intracoronary OCT-NIRAF is safe and feasible in patients
2) NIRAF was elevated focally in portions of the coronary artery that contained high risk OCT features, and
3) The findings are suggestive that NIRAF may be a new imaging feature that is indicative of inflammation in human coronary lesions in vivo.
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 study? Dr. Boyle: For infants who are fed with formula milk, special hydrolysed formula is widely recommended if they are at risk of allergies, on the basis that this might reduce...
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.