MedicalResearch.com Interview with:
Joshua P. Cohen Ph.D
Research Associate Professor
Tufts Center for the Study of Drug Development
Boston, Massachusetts
Medical Research: What is the background for this study?
Dr. Cohen: Florbetapir 18F was the first radioactive diagnostic agent approved by the US Food and Drug Administration for positron emission tomography imaging of the brain to evaluate amyloid â neuritic plaque density.
Medical Research: What are the main findings?Dr. Cohen: Medicare has restricted coverage of florbetapir in the US, whereas conspicuously the UK NHS decided to reimburse the radiopharmaceutical. Note, the British NHS is generally more restrictive with regard to coverage of new technologies than the Centers for Medicare and Medicaid Services. Historically Medicare has rejected coverage of 25% of diagnostics approved by the FDA, but covers all FDA approved drugs administered in the physicians office. Furthermore, Medicare has subjected labeled use of diagnostics, including a half-dozen Alzheimer's diagnostics, to its coverage with evidence development program while not subjecting any labeled uses of drugs to coverage with evidence development. In sum, diagnostics are subject to a level of scrutiny by Medicare that is rarely given Medicare Part B drugs (physician-administered).
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MedicalResearch.com Interview with:
Igho Onakpoya MD MSc
Clarendon Scholar
University of Oxford
Centre for Evidence-Based Medicine
Nuffield Department of Primary Care Health Sciences
Oxford UK
MedicalResearch: What is the background for this study? What are the main findings?Dr. Onakpoya: Several orphan drugs have been approved for use in Europe. However, the drugs are costly, and evidence for their clinical effectiveness are often sparse at the time of their approval.
We found inconsistencies in the quality of the evidence for approved orphan drugs. We could not identify a clear mechanism through which their prices drugs are determined. In addition, the costs of the branded drugs are much higher than their generic or unlicensed versions.
MedicalResearch: What should clinicians and patients take away from your report?Dr. Onakpoya: Because of inconsistencies in the evidence regarding the benefit-to-harm balance of orphan medicines, coupled with their high prices, clinicians and patients should assess whether the orphan drugs provide real value for money before making a decision about their use for a medical condition.
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MedicalResearch.com Interview with:
John Maret-Ouda MD, PhD candidate
Upper Gastrointestinal Surgery
Department of Molecular medicine and Surgery
Karolinska Institutet
Stockholm, Sweden
MedicalResearch: What is the background for this study? What are the main findings?Dr. Maret-Ouda : This review is part of the BMJ series “Uncertainties pages”, where clinically relevant, but debated, medical questions are highlighted and discussed. The present study is assessing treatment of severe gastro-oesophageal reflux disease, where the current treatment options are medical (proton-pump inhibitors) or surgical (laparoscopic antireflux surgery). The clinical decision-making is often left to the clinician and local guidelines. We evaluated the existing literature to compare the two treatment options regarding reflux control, complications, future risk of oesophageal adenocarcinoma, health related quality of life, and cost effectiveness.
The main findings were that surgery might provide slightly better reflux control and health related quality of life, but is associated with higher risks of complications compared to medication. A possible preventive effect regarding oesophageal adenocarcinoma remains uncertain. Regarding cost effectiveness, medication seems more cost effective in the short term, but surgery might be more cost effective in the longer term. Since medication provides good treatment of severe gastro-oesophageal reflux disease, but with lower risks of complications, this remains the first line treatment option.
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MedicalResearch.com Interview with:
Siv Klevar, DVM,PhD.
Norwegian Veterinary Institute
Department of Diagnostics
Section of Immunology
Oslo
Medical Research: What is the background for this study?
Dr. Klevar: Border control veterinary officers reported a surge in the number of imported dogs after the pet travel regulations were relaxed in 2012. At the same time rescue groups, through social media advertisement, encouraged and facilitated the adoption of dogs from shelters in Eastern Europe. The removal of the requirement regarding individual serological testing for antibodies to rabies before importing pets into UK, Ireland, Sweden, Malta and Norway, made it much easier to import pets into these countries. Previously import required several months of preparation and additional costs whereas under the new regulations it could be done after a single vaccination and a 3 week wait. The Norwegian Food Authority initiated a project to look at exotic pathogens in these re-homed dogs. This study reports the rabies antibody levels detected in some of the rehomed stray dogs entering Norway during 2012. The Norwegian Veterinary Institute and National Veterinary Institute in Sweden carried out the study.
Medical Research: What are the main findings?
Dr. Klevar: Our results showed that a high proportion of stray dogs, compared to a control group of pet dogs from Sweden, didn’t have sufficient protection against rabies virus after vaccination. Although we do not know exactly why this was the case, the exceedingly low levels of antibodies detected in some of the stray animals would suggest that they were not properly vaccinated, even though all the paperwork showed they were fully compliant with Pet Travel Regulations.
The main issue highlighted by this study is that the current regulations are not sufficient to prevent rabies introduction when importing rescue dogs from countries where the virus is present to countries free from the disease. The reason for this is that the current regulations do not require a check to see if the pet has been properly vaccinated (by testing the animal’s blood for antibodies). In addition to this, the 21 day waiting period after vaccination isn’t long enough for rabies to develop if the dog had been infected prior to vaccination.
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MedicalResearch.com Interview with:
Dr Matthew Miller
Department of Health Science Northeastern University
Department of Health Policy and Management,
Harvard T.H. Chan School of Public Health Harvard University
Boston, Massachusetts
and Yi-Han Sheu
Department of Epidemiology
Harvard T.H. Chan School of Public Health
Harvard University Boston, Massachusetts
Medical Research: What is the background for this study?
Response: Selective serotonin reuptake inhibitors (SSRIs) were recently approved by the FDA to treat vasomotor symptoms associated with menopause. No prior study has directly examined whether fracture risk is increased among perimenopausal women who initiate SSRIs or among a population of women without mental disorders more generally..
Medical Research: What are the main findings?
Response: We found that SSRIs treatment for non-psychiatric conditions at doses customarily used to treat depression is, all else equal, associated with higher rates of fractures -- an effect that first became evident several months after beginning treatment and, importantly, persisted over the five year study period.
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MedicalResearch.com Interview with:
Prof. Jason Smith
Consultant in Emergency Medicine, Derriford Hospital, Plymouth, UK
Royal College of Emergency Medicine Professor
Defence Professor of Emergency Medicine, Academic Department of Military Emergency Medicine, Royal Centre for Defence Medicine, UK
Honorary Professor in Emergency Medicine, Plymouth University Peninsula Schools of Medicine and Dentistry, UK
Medical Research: What is the background for this study?Prof. Smith: Patients commonly present to emergency departments in pain. When patients are asked about their emergency department experience, they often say that more could have been done to manage their pain.
Routine care for patients in moderate or severe pain who present to emergency departments usually involves intravenous (IV) morphine, delivered by a nurse. There may be a delay when patients are admitted to a hospital ward before they are reviewed by the admitting medical team, when their pain needs are reassessed.
Patient controlled analgesia (PCA) is used to good effect elsewhere in the hospital.
The aim of this study was to compare PCA with routine care in patients presenting to emergency departments with either traumatic injuries or non-traumatic abdominal pain, who require admission to hospital.
Medical Research: What are the main findings?Prof. Smith: We found that significant reductions in pain were possible using patient controlled analgesia in patients with abdominal pain. Patients spent significantly less time in moderate or severe pain, and were more likely to be very or perfectly satisfied with their pain management.
In patients with traumatic injuries, a modest (but non-significant) reduction in pain was seen in patients allocated to the PCA group compared with the routine care group. Patients in the PCA group were more likely to be very or perfectly satisfied with their pain management. (more…)
MedicalResearch.com Interview with:
Dr. Andrea Tricco Ph.DDalla Lana School of Public Health
University of Toronto
Medical Research: What is the background for this study? What are the main findings?
Dr. Tricco: We were commissioned by Health Canada to assess the safety and effectiveness of serotonin (5-HT3) receptor antagonists in patients undergoing surgery. In order to examine this research question, we conducted a systematic review and network meta-analysis including >450 studies.
We found that more patients receiving granisetron plus dexamethasone experienced arrhythmia compared to all other interventions and placebo. No differences were observed regarding mortality and QT prolongation in meta‐analysis; no studies reported on PR prolongation or sudden cardiac death. Granisetron plus dexamethasone was often the most effective antiemetic, with the number needed to treat ranging from two to nine. We found that ondansetron plus droperidol intravenous (IV) was also a highly effective antiemetic for decreasing the risk of vomiting and post-operative nausea and vomiting (PONV). (more…)
MedicalResearch.com Interview with:Mr. Angus Turnbull
Imperial College School of Medicine,
London UK
Medical Research: What is the background for this study? What are the main findings?
Mr. Turnbull: Autopsy has been used to advance medical knowledge and understanding of pathological processes for millennia but increasing evidence indicates its decline in the UK and elsewhere. This study not only confirms that but suggests autopsy for learning purposes has almost disappeared.
In the United Kingdom autopsy is divided into medico-legal autopsy (that required by law under the jurisdiction of HM Coroner) and consented autopsy (performed with the consent of the bereaved or their family). Over the past half-century, small single site studies have noted a marked decline in consented autopsy rates, however there has been no study for over 20 years to determine the extent of the decline nationwide.
This study examined all acute NHS Trusts within England, NHS Boards in Scotland and Wales and Social Care Trusts in Northern Ireland. We found that the average autopsy rate (the percentage of adult inpatient deaths which under go consented autopsy) in the United Kingdom in 2013 was only 0.7%. The study showed that in nearly a quarter (23%) of all NHS Trusts in the United Kingdom, consented autopsy is now extinct.
These findings may have implications for training, for research and for learning from mortality – a key aspect of patient safety. (more…)
MedicalResearch.com Interview with:
Professor Phyo Kyaw Myint MBBS MD FRCP(Edin) FRCP(Lond)
Clinical Chair in Medicine of Old Age
Epidemiology Group, Division of Applied Health Sciences
University of Aberdeen
Scotland
Medical Research: What is the background for this study? What are the main findings?
Response: The research was carried out by academics from the Universities of Aberdeen, Manchester, Cambridge and East Anglia, as well as the Lancashire Teaching Hospital, the Medical Research Council Epidemiology Unit, Cambridge and the Academic Medical Centre, Amsterdam. It has been published online in the journal Heart. The team base their findings on almost 21,000 adults taking part in the EPIC-Norfolk study, which is tracking the impact of diet on the long term health of 25,000 men and women in Norfolk, England, using food frequency and lifestyle questionnaires. The researchers also carried out a systematic review of the available international published evidence on the links between chocolate and cardiovascular disease, involving almost 158,000 people—including the EPIC study participants.
The EPIC-Norfolk participants (9214 men and 11 737 women) were monitored for an average of almost 12 years, during which time 3013 (14%) people experienced either an episode of fatal or non-fatal coronary heart disease or stroke. Around one in five (20%) participants said they did not eat any chocolate, but among the others, daily consumption averaged 7 g, with some eating up to 100 g.
Higher levels of consumption were associated with younger age and lower weight (BMI), waist: hip ratio, systolic blood pressure, inflammatory proteins, diabetes and more regular physical activity —all of which add up to a favourable cardiovascular disease risk profile. Eating more chocolate was also associated with higher energy intake and a diet containing more fat and carbs and less protein and alcohol.
The calculations showed that compared with those who ate no chocolate higher intake was linked to an 11% lower risk of cardiovascular disease and a 25% lower risk of associated death. It was also associated with a 9% lower risk of hospital admission or death as a result of coronary heart disease, after taking account of dietary factors. And among the 16,000 people whose inflammatory protein (CRP) level had been measured, those eating the most chocolate seemed to have an 18% lower risk than those who ate the least. The highest chocolate intake was similarly associated with a 23% lower risk of stroke, even after taking account of other potential risk factors.
Of nine relevant studies included in the systematic review, five studies each assessed coronary heart disease and stroke outcome, and they found a significantly lower risk of both conditions associated with regular chocolate consumption. And it was linked to a 25% lower risk of any episode of cardiovascular disease and a 45% lower risk of associated death.
The study concluded that cumulative evidence suggests higher chocolate intake is associated with a lower risk of future cardiovascular events.
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MedicalResearch.com Interview with:
Anne Winther Msc
Department of Health and Care Sciences, UiT The Arctic University of Norway
Division of Rehabilitation Services, University Hospital of North Norway, Tromsø, Norway
Medical Research: What is the background for this study? What are the main findings?
Response: Norway has one of the highest reported incidences of osteoporotic fractures in the world. Research on fracture risk has primarily focused on bone mass in the elderly. However, there is a growing awareness of the importance of bone mass during growth as a compensation for the inevitable bone loss and prevention of fractures in the elderly . A recent study on Norwegian adolescents´ lifestyle and bone health concluded that peak bone mass seem to be modifiable by lifestyle factors as higher physical activity levels were strongly associated with bone mass. The other way around; low levels of physical activity may have considerable negative effects on bone health, and increasing sedentary behavior in place of sports and play during growth is worrying. In this study we explored the associations between self-reported hours spent in front of television/computers during weekends along with self reported hours spent on leisure time physical activities and bone mass density (BMD) levels at the hip. This population based study, Fit Futures 1 consisting of 388 girls and 359 boys 15-17 years old was conducted in 2010/2011, and repeated two years later including 66% of the original cohort (Fit Futures 2; 312 girls and 231 boys).
Boys spent more time in front of computers and television than girls; approximately 5 and 4 hours, compared with 4 and 3 hours daily in weekends and weekdays, respectively.
Physical activity levels were adversely related to leisure time computer use at weekends. However, 20 % of the girls and 25 % of the boys balanced 2-4 hours in front of the screen daily with more than 4 hours of sports and hard training per week.
Screen time at weekends was negatively associated with bone mass density levels in boys and positively in girls, after adjustments of several confounders known to affect bone, including age, puberty, physical activity levels and weekday screen time.
Moreover; these contrasting patterns persisted two years later.
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MedicalResearch.com Interview with:
Nynne Nyboe Andersen, MD, PhD student
Department of Epidemiology Research
Statens Serum Institut
Copenhagen, Denmark Medical Research: What is the background for this study? What are the main findings?
Dr. Andersen: The use of TNF-α inhibitors, including infliximab, adalimumab and certolizumab pegol to treat people with inflammatory bowel disease is increasing worldwide and has upgraded the medical treatment modalities. However, concerns about their safety, including an increased risk of serious infections have persisted because they suppress the immune system. Previous meta-analyses based on randomized controlled trials did not suggest an increased risk of serious infections in people with inflammatory bowel disease treated with TNF-α inhibitors compared to placebo. However, the trials included in the meta-analyses were designed to investigate efficacy, and not to analyze risk of rare adverse events such as serious infections and often represent selected populations. Therefore, observational studies are essential to evaluate safety in a real world setting; however, results from these studies have been conflicting. Thus, as the risk of infections associated with TNF-α inhibitor treatment in people with inflammatory bowel disease is unclear we aimed at investigating this potential risk in a population-based setting based on the entire Danish inflammatory bowel disease population.
In a propensity score matched cohort we found a significant 63% increased risk of serious infections within 90 days after treatment initiation. When we prolonged follow-up to 356 days the risk was attenuated and no longer significant. For site-specific serious infections, we found increased point estimates for sepsis, urological/gynecological infections, and skin and soft tissue infections; but these results should be interpreted cautiously because of limited power.
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MedicalResearch.com Interview with: Bilal Chughtai, MD & Art Sedrakyan, MD, PhD
Department of Urology
Weill Cornell Medical College
Medical Research: What is the background for this study? What are the main findings?
Response: Since 2008, the U.S. Food and Drug Administration has released number of public health notifications cautioning the use of mesh in pelvic organ prolapse (POP) surgery. Despite these notifications and subsequent public scrutiny, studies have reported a large increase of mesh use in female patients with pelvic organ prolapse during the last decade. In light of the reported rise in mesh utilization, we sought to determine the use of mesh in prolapse surgery and compare short-term outcomes of prolapse surgery with or without mesh.
After identifying 7,338 and 20,653 patients who underwent prolapse repair procedures with and without mesh in a 4-year period, we found that mesh use increased 44.7%. Most patients were under 65 (62.3%), and there were more patients older than 65 years in the mesh group (44.3% versus 35.4%). Overall, complications were not common. However, patients who received mesh were more likely to experience urinary retention within 90-days and had a higher chance of having re-intervention at 1 year. Mesh use was also associated with higher risk of urinary retention in older patients (≥ 65 year olds) and re-intervention within 1 year in younger patients (<65 year olds).
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MedicalResearch.com Interview with:
Prachi Bhatnagar, MPH, DPhil
Researcher University of Oxford
British Heart Foundation Centre on Population Approaches for Non-Communicable Disease Prevention
Nuffield Department of Population Health
Oxford
Medical Research: What is the background for this study? What are the main findings?
Response: We know that cardiovascular disease presents a large burden to the UK. We aimed to bring together all the main data on cardiovascular disease mortality, morbidity, treatment and economic costs. We found that there are regional inequalities in cardiovascular disease mortality and prevalence in the UK.
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MedicalResearch.com Interview with:
Dr. Lucy Bowes Ph.D
Leverhulme Early Career Research Fellow
Fellow of Magdalen College
Department of Experimental Psychology
University of Oxford Oxford
Medical Research: What is the background for this study? What are the main findings?
Response: Major depression is a severe mental illness, and a leading contributor to the global burden of disease. Rates of depression begin to rise in the teenage years, though the reasons for this remain unclear. Peers become particularly important during this time, and victimisation by peers or “bullying” has been proposed as one potentially modifiable risk factor for depression. There are robust findings that peer victimisation in childhood is associated with short-term internalizing symptoms, however it remains unclear whether victimization in the teenage years is associated with major depression. Only a relatively small number of longitudinal studies have prospectively investigated victimisation in relation to depression meeting diagnostic criteria in late adolescence or adulthood. Limitations of these studies include poor measures of bullying, lack of adjustment for key confounders such as baseline emotional and behavioral difficulties and child maltreatment.
Our prospective cohort observational study, published in The BMJ, used detailed self-report data on peer victimisation at 13 years from 6,719 participants of the ALSPAC or ‘Children of the 90s’ study. The outcome was depression at 18 years, measured using a self-administered computerised version of the Clinical Interview Schedule Revised, CIS-R (data available for 3,898 participants). We adjusted for a range of confounders including baseline emotional and behavioral problems, family background and other risk factors. Of the 683 children who reported frequent victimisation at 13 years, 101 (14.8%) were depressed at 18 years. Of the 1,446 children reporting some victimisation, 103 (7.1%) were depressed, and of the 1,769 children reporting no victimisation at 13 years, 98 (5.5%) were depressed. Children who were frequently victimized had over a two-fold increase in odds of depression compared with children who were not victimized by peers. This association was slightly reduced when adjusting for key confounders. The population attributable fraction suggested that 29% of depression at 18 could be explained by peer victimisation if this were a causal relationship.
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MedicalResearch.com Interview with:
Alexandra Gonçalves, MD, PhD
Postdoctoral Research Fellow
Cardiovascular Department
Brigham and Women's Hospital
Boston, MA 02115
MedicalResearch.com: What is the background for this study?Dr. Gonçalves: Excessive alcohol consumption is associated with alcoholic cardiomyopathy, while light to moderate drinking might have benefits in the risk of heart failure (HF). However, the cardiovascular mechanisms and the alcohol dosage associated with risks or potential benefits are uncertain. Furthermore, the variation in the toxic and protective effects of alcohol by sex remains controversial, as women may be more sensitive than men to the toxic effects of alcohol on cardiac function, developing alcoholic cardiomyopathy at a lower total lifetime dose of alcohol compared to men. In this study we assessed the associations between alcohol intake and cardiac structure and function by echocardiography, in elderly men and women in the large, community-based Atherosclerosis Risk in Communities (ARIC) Study.
MedicalResearch.com: What are the main findings?Dr. Gonçalves: We studied 4466 participants (76±5 years and 60% women) with alcohol consumption ascertained, who underwent transthoracic echocardiography. Participants were classified into 4 categories based on self-reported alcohol intake: non-drinkers, drinkers of up to 7 drinks per week, ?7 to 14 and ? 14 drinks per week. In both genders, increasing alcohol intake was associated with larger left ventricular (LV) diastolic and systolic diameters and larger left atrial diameter. In men, increasing alcohol intake was associated with greater LV mass and higher E/E’ ratio. In women, increasing alcohol intake was associated with lower LV ejection fraction. (more…)
MedicalResearch.com Interview with: Yana Vinogradova, Research Fellow
Division of Primary Care
School of Medicine
University of NottinghamMedical Research: What is the background for this study? What are the main findings?
Response: Combined oral contraceptives are an effective method of birth control but do have measurable side effects. One – common to all combined contraceptives and sometimes fatal – is an increased risk of venous thromboembolism (VTE). A number of earlier studies investigated VTE risks for different types of hormonal contraceptives, but all were performed some years ago or had insufficient data to analyse newer preparations, while some included only healthy users and others did not adequately control for lifestyle and health issues. The data used for this study were representative of the UK population and covered all currently prescribed drugs, with results adjusted for the widest possible range of available relevant factors.
We found that the venous thromboembolism risks of combined oral contraceptives appear to fall into two distinct groups. Newer drugs containing gestodene, desogestrel, drospirenone or cyproterone were associated with risks of VTE between 1.5 and 1.8 times higher than both the older compositions containing norethisterone or levonorgestrel and the relatively newer norgestimate. While our findings are statistical associations between different compositions and venous thromboembolism risks, they do represent more comprehensive and reliable information for doctors making evidence-based prescribing decisions. (more…)
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:
Christophe Tzourio, MD, PhD
Professor of Epidemiology
University of Bordeaux
Medical Research: What is the background for this study? What are the main findings?
Dr. Tzourio: The efficacy of lipid-lowering drugs (LLD) - which include statins and fibrates - to reduce the risk of coronary events and stroke has already been demonstrated in randomized trials. However, these trials were performed on highly selected patients, usually of middle-age (50-70 yrs) and with a history of cardiovascular disease or a high vascular profile. There is therefore currently no indication on the benefit of these drugs in elderly individuals of the general population without a past-history of cardiovascular disease and guidelines do not recommend the use of lipid-lowering drugs in elderly individuals without clinical atherosclerotic disease.
As there are not randomized trials in non-selected individuals in this age category, observational population-based cohorts are therefore the only alternative to study the impact of lipid-lowering drugs on the risk of cardiovascular diseases in the elderly.
We analyzed data from the Three-City study, a community-based cohort in 7484 elderly individuals (mean age 74 years), followed-up during 9 years, without known history of vascular disease at baseline. We observed a one third decrease in the risk of stroke in lipid lowering drug users (hazard ratio 0.66, 0.49 to 0.90) compared with non-users. Reduction in stroke risk was similar for the statin and fibrate groups. No protective effect was seen on the risk of coronary heart disease. (more…)
MedicalResearch.com Interview with:Dr. Shang-Ming Zhou
Senior Lecturer in Statistical Modelling and Analytics for Epidemiology and Public Health,
Public Health Informatics Group,
Health Information Research Unit (HIRU),
UKCRC DECIPHer (Development and Evaluation of Complex Interventions for Public Health Improvement) Centre,
College of Medicine, Swansea University, Swansea, UK
Medical Research: What is the background for this study? What are the main findings?Response: In medical and sport science research, body-worn accelerometers are widely used to provide objective measurements of physical activity. However, accelerometers collect data continuously even during periods of nonwear (i.e. periods when participants may not be wearing their monitor, such as during sleeping). It is important to distinguish time of sedentary behaviours (eg. watching television) from time of nonwear. The clinical consequence of misclassification of accelerometer wear and nonwear would overestimate or underestimate physical activity level, and mislead the interpretation of the relationship between physical activity and health outcomes. Automated estimation of accelerometer wear and nonwear time events is particularly desired by large cohort studies, but algorithms for this purpose are not yet standardized and their accuracy needs to be established. This study presents a robust method of classifying wear and nonwear time events under free living conditions for triaxial accelerometers which combines acceleration and surface skin temperature data.
The new findings are: Either acceleration data or skin temperature data alone is inadequate to accurately predict wear and nonwear events in some scenarios under a free living condition; This study provides a simple and efficient algorithm on use of short time periods of consecutive data blocks for accurately predicting triaxial accelerometer wear and nonwear events; Combining both types of acceleration and skin temperature data can significantly improve the accuracy of accelerometer wear and nonwear events classification in monitoring physical activity. (more…)
MedicalResearch.com Interview with:
Dr. Johannes Berkhof
Department of Epidemiology and Biostatistics, VU University Medical Centre
Amsterdam
Centre for Infectious Disease Control,
National Institute for Public Health and the Environment, Bilthoven, Netherlands
Medical Research: What is the background for this study? What are the main findings?Response: Vaccination against the sexually transmitted human papillomavirus (HPV) is offered free-of-charge to 12-year-old girls in the Netherlands.
There is strong evidence that HPV also causes cancer in men: the virus is associated with cancers of the penis, anus, and oropharynx, and possibly with a small proportion of oral cancers. A number of these cancers will be prevented because vaccination of girls leads to a decrease of HPV in the general population and thus provides indirect protection to heterosexual men.
However, vaccine uptake among girls is only about 60 percent in the Netherlands. Moreover, men who have sex with men are at increased risk of HPV-related cancer and will not be protected by vaccination of girls.
On the basis of data from several epidemiological studies and a dynamic model for virus transmission, we calculated that, if the vaccine uptake is low, about 200 girls need to be vaccinated to prevent one case of cervical cancer and 470 boys need to be vaccinated to prevent one case of cancer in men.
An increase in vaccine uptake in girls will decrease the HPV infection risk in heterosexual men and if the uptake in girls is 60 percent, around 800 boys need to be vaccinated to prevent one additional case of cancer in men.
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MedicalResearch.com Interview with:
Dr. Brian Rowe, MD, MSc, CCFP(EM), FCCP
Professor, Department of Emergency Medicine
University of Alberta, Edmonton, Alberta, Canada
MedicalResearch: What is the background for this study? Dr. Rowe: Frequent users are also called “familiar faces” or “heavy users” and they represent an important sub-group of patients in the emergency setting, with often complex needs that contribute to overcrowding and excess health care costs. The evidence suggests that frequent users account for up to one in 12 patients seeking emergency care, and for around one in four of all visits.
MedicalResearch: What are the main findings?Dr. Rowe: Frequent users of emergency department care are more than twice as likely to die, be admitted to hospital, or require other outpatient treatment as infrequent users, concludes an analysis of the available evidence, published in Emergency Medicine Journal.
These conclusions are based on a thorough search of seven electronic databases of relevant research relating to the frequency and outcomes of emergency department use by adults. Out of a total of more than 4000 potential studies, 31 relevant research reports published between 1990 and 2013 were included in the final analysis. Frequent users were variably defined as visiting emergency care departments from four or more times up to 20 times a year.
Among the seven studies looking at deaths, the analysis showed that frequent attenders at emergency care departments were more than twice as likely to die as those who rarely sought emergency care. Most of the studies included hospital admission as an outcome, and these showed that frequent users were around 2.5 times as likely to be admitted as infrequent users. Ten studies looked at use of other hospital outpatient care, and these showed that frequent users were more than 2.5 times as likely to require at least one outpatient clinic after their visit to the emergency care department.
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MedicalResearch.com Interview with:
Donna Zulman MD MS
Center for Innovation to Implementation, VA Palo Alto Health Care System, Menlo Park
Division of General Medical Disciplines, Stanford University, Stanford California, USA
Medical Research: What is the background for this study?
Dr. Zulman: Within the United States, a small number of individuals account for disproporationate health care spending. Many of these high-cost patients have complex chronic conditions such as heart failure and diabetes. Others have complicated mental health conditions. But the vast majority have multiple chronic conditions, which can create challenges when patients are navigating their health care. For this study, we examined patterns of chronic conditions among high-cost patients in the Veterans Affairs (VA) Health Care System, and studied the relationship between different chronic conditions patterns and health care utilization and costs.
Medical Research: What are the main findings?Dr. Zulman: We found that within the VA, the 5% highest cost patients accounted for 47% of total VA health care costs. Approximately two-thirds of these patients had chronic conditions affecting 3 or more body systems (for example, cardiovascular disease, asthma, and depression). However, patients with severe, dominating diseases such as cancer and schizophrenia were less likely to have a lot of comorbid conditions.
In addition, we found that even among these high-cost patients, having more conditions was associated with greater use of outpatient and inpatient services. However, as patients' multimorbidity across body systems increased, a greater share of their costs was generated in the outpatient setting and a smaller share of their costs was generated in the inpatient setting. This suggests that interventions focusing on high-cost patients should not only target costly hospitalizations, but should also coordinate and maximize efficiency of outpatient services across multiple conditions. (more…)
MedicalResearch.com Interview with: Professor Hossam Haick Ph.D
Department of Chemical Engineering and Russell Berrie Nanotechnology Institute
Haifa, Israel
Medical Research: What is the background for this study? What are the main findings?
Dr. Haick: Our study is based on the hypothesis that timely detection of premalignant lesions (PMLs) may provide a tool to decrease either cancer mortality or incidence, thought, currently, there is no perfect non-invasive tool to screen for gastric cancer (GC) and the related premalignant lesions. Using 1002 samples collected from 501 volunteers, we show for the first time that premalignant lesions (PMLs) relevant to (gastric) cancer result in detectable differences in Volatile Organic Compound (VOC) signatures that can be detected and classified non-invasively through exhaled breath. We show additionally that these premalignant lesions can be well-discriminated from various stages of gastric cancer as well as other background stomach diseases.
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MedicalResearch.com Interview with:
Gustavo C Machado, PhD student
The George Institute for Global Health, Sydney Medical School
University of Sydney Sydney Australia
(Editor’s note: Paracetamol isalso known as acetaminophen)
MedicalResearch: What is the background for this study? What are the main findings?
Response: Back pain and osteoarthritis are the two major musculoskeletal conditions affecting people worldwide, and paracetamol is the most used over the counter medicine to treat these conditions. Recent debates on the efficacy and safety of paracetamol prompted us to conduct a systematic review of literature on the efficacy of this medication. In our study we included all available clinical trials that compared paracetamol to placebo, and our conclusions are based on data from more than 5,300 patients with low back pain and hip or knee osteoarthritis. We found that paracetamol is ineffective for low back pain and provides small and not clinically important benefits to patients with osteoarthritis.
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MedicalResearch.com Interview with:
Melinda C Power, ScD
Post-Doctoral Research Fellow
Epidemiology Department, Johns Hopkins Bloomberg School of Public Health
Neurology Department, Johns Hopkins School of Medicine
Medical Research: What is the background for this study? What are the main findings?
Dr. Power: Air pollution may be related to mental health, particularly anxiety, through effects on oxidative stress and systemic inflammation or through promotion or aggravation of chronic diseases. However, there has been very little research on the relation between air pollution exposures and anxiety in people. Our study found that those with higher exposures to fine particulate matter, a type of air pollution, were more likely to experience elevated anxiety symptom levels. Our study also suggests that recent exposures to find particulate matter air pollution are potentially more relevant to anxiety symptom levels than long-term past exposures.
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MedicalResearch.com Interview with:
Dr Anoop Shah
Cardiology Research fellow
Centre of Cardiovascular sciences
University Of Edinburgh Edinburgh
Medical Research: What is the background for this study? What are the main findings?
Response: Stroke accounts for five million deaths each year and is a major cause of disability. The incidence of stroke is increasing, particularly in low and middle income countries, where two thirds of all strokes occur. The global burden of stroke related disability is therefore high and continues to rise. This has been primarily attributed to an aging population in high income countries and the accumulation of risk factors for stroke, such as smoking, hypertension, and obesity, in low and middle income countries. The impact of environmental factors on morbidity and mortality from stroke, however, might be important and is less certain.
From 103 studies and across 6.2 million fatal and non-fatal strokes, our findings suggest a strong association between short term exposure to both gaseous (except ozone) and particulate air pollution, and admissions to hospital for stroke or mortality from stroke. These associations were strongest in low and middle income countries, suggesting the need for policy changes to reduce personal exposure to air pollutants especially in highly polluted regions.
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MedicalResearch.com Interview with:
Minna Johansson, PhD student
Department of Public Health and Community Medicine, Institute of Medicine
The Sahlgrenska Academy, University of Gothenburg, Gothenburg, Research Unit and Section for General Practice, Vänersborg, SwedenMedical Research: What is the background for this study? What are the main findings?
Response: The decision to introduce screening for abdominal aortic aneurysms (AAA) was based on four randomised controlled trials from the 1980s and 1990s that showed a 50% relative risk reduction in aneurysm-related mortality. Over the last 15 years Sweden, the UK and the USA have introduced AAA screening programmes.
However, abdominal aortic aneurysms screening does not only have intended benefits but also unintended harms. The most important harm is overdiganosis; i.e. the overdetection of aneurysms that would not have caused symptoms in that man´s remaining life, nor been the cause of his death. In this study, we estimate that 176 of every 10,000 men invited to screening are overdiagnosed as a consequence of screening. These men are unnecessarily turned into patients and may experience appreciable anxiety throughout their remaining lives. Moreover, 37 of these men unnecessarily have preventive surgery and 1.6 of them die as a consequence.
Furthermore, a recent drop in abdominal aortic aneurysms prevalence by over 70% reduces the potential benefits of AAA screening. Unfortunately, the harms are not likely to be reduced by the same rate, thus leading to a worsened benefit:harm ratio. This means that the benefit:harm ratio is likely to be worse in current screening programmes than in the trials on which they were based.
Additionally, it has been proposed to lower the cut-off for the abdominal aortic aneurysms-diagnosis from 30 to 25 mm. Our estimates show that such a change of definition would increase the rate of overdiganosis substantially and further worsen the benefit:harm ratio of abdominal aortic aneurysms screening.
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MedicalResearch.com Interview with:
Prof. Dr. med. Paul Erne
AMIS Plus Data Center, Epidemiology, Biostatistics and Prevention Institute
University of Zurich
Department of Cardiology
Clinic St. Anna, Lucerne and University Hospital Zurich
Zurich, Switzerland
MedicalResearch: What is the background for this study? What are the main findings?Prof. Erne: Very little is known on this important subgroup of patients with Acute Coronary Syndrome (ACS) at admission who for various reasons receive restricted or palliative treatment only. Reasons for withholding comprehensive and/or invasive therapy may be the very limited life expectancy, advanced age or severe comorbidities. These patients are not represented in prospective trials and often not included in outcome statistics and registries.
This study provides evidence that the population which received palliative therapy is older and sicker when compared to patients who underwent conservative or reperfusion treatment. However, this study shows that these decisions are very individually addressed. Acute Coronary Syndrome patients treated palliatively were older, sicker, with more heart failure at admission and very high in-hospital mortality. Changes of treatment decisions over time and the proportion of patients surviving 1 year suggest in part non homogenous and potentially questionable decision criteria. While refraining from more active therapy may be the most humane and appropriate approach in many patients, in others it represents under treatment.
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MedicalResearch.com Interview with:
Ina S. Santos (on behalf of the co-authors)
Iná S. Santos, MD, PhD
Professora Titular Depto Medicina Social
Programa Pós-graduação Epidemiologia
Universidade Federal de Pelotas, Brasil
MedicalResearch: What is the background for this study? What are the main findings?Response: Early regulatory problems (excessive crying, sleeping and feeding problems in infancy) have been considered early markers for similar processes of inadequate or under-controlled behavior in childhood and psychosocial problems in childhood are associated with psychological disorders later in life. The prevalence of excessive crying during the first 3 months of life in representative community-based samples from high-income countries has been reported to range between 14% and 29%.
There is no consensus regarding the definition of excessive crying. A frequently used definition is the excessive paroxysmal crying, that is most likely to occur about the same time every day (usually in the late afternoon or evenings) without any identifiable cause in an otherwise healthy baby aged 2 weeks to 4 months and lasting more than three hours per day, occurring in more than three days in any week for three weeks (rule of three) that is typically known as colic. Others give less emphasis to the amount of crying and give relevance to maternal or parental stress due to the child unresponsiveness to soothing or to the maternal perception of the intensity of crying.
Negative consequences of excessive crying on maternal and child health have been described: it is associated with early weaning from breast milk, frequent changes of formulae, and maternal mental symptoms, besides being the most common proximal risk factor for shaken baby syndrome.
In a study conducted in a middle-sized city located in Southern Brazil, 4231 children enrolled in the 2004 Pelotas Birth Cohort were followed-up from birth to four years of age. At the 3-month post-partum follow-up mothers were asked whether their infants cried more, less or as the same as others of the same age. Infants whose mothers perceived them as crying more than others of the same age were classified as “crying babies”. When the cohort reached four years old, all children were screened to assess their risk of presenting psychological problems. After taking into account a series of maternal and child characteristics (like, maternal age, maternal level of education, type of delivery, gestational age at birth, and child sex, among others) “crying babies” were at increased risk of presenting behavior problems in comparison to “non-crying babies”.
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MedicalResearch.com Interview with:
Professor Stephen Peckham
Director, Centre for Health Services Studies
Professor of Health Policy
Department of Health Services Research and Policy
London School of Hygiene and Tropical Medicine
Director, Policy Research Unit in Commissioning and the Healthcare System University of Kent
Medical Research: What is the background for this study? What are the main findings?
Response: Community water fluoridation remains a controversial public health measure. There have been continued debates about both its effectiveness in the prevention of dental caries and also its safety. Previous studies have suggested that there is an association between fluoride ingestion and the incidence of hypothyroidism few population level studies have been undertaken. In April 2014 Public Health England published a monitoring report that used secondary analysis of routine health statistics to identify whether water fluoridation in England was associated with any adverse health outcomes. While hypothyroidism data is available this was not included in their monitoring report. In England approximately 10% of the population lives in areas with community fluoridation schemes and hypothyroidism prevalence can be assessed from general practice data. Tt examine whether there is a relationship – as suggested in smaller studies – we used a cross-sectional study design using secondary data to develop binary logistic regression models of predictive factors for hypothyroidism prevalence at practice level using 2012 data on fluoride levels in drinking water, 2012/13 Quality Outcomes Framework (QOF) diagnosed hypothyroidism prevalence data, 2013 General Practitioner (GP) registered patient numbers, and 2012 practice level Index of Multiple Deprivation scores. We found a positive association between fluoride levels and hypothyroidism. High hypothyroidism prevalence was found to be at least 30% more likely in practices located in areas with fluoride levels in excess of 0.3mg/L. This population study supports earlier hypotheses that fluoride is associated with hypothyroidism. In the UK water is fluoridated at 1ppm (1mg/L) and in areas where water is fluoridated the model predicts that after controlling for other factors, practice populations are significantly more likely to have higher levels of hypothyroidism than those in non-fluoridated areas. Higher levels of fluoride in drinking water, therefore, provide a useful contribution for predicting prevalence of hypothyroidism. For example in contrasting two urban areas we found that practices located in the West Midlands (a wholly fluoridated area) are nearly twice as likely to report high hypothyroidism prevalence in comparison to Greater Manchester (non-fluoridated area).
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