MedicalResearch.com Interview with: Prof. Raj S Bhopal
Bruce and John Usher Professor of Public Health
Edinburgh Ethnicity and Health Research Group,
Centre for Population Health Sciences,
University of Edinburgh, Teviot Place, Edinburgh EH89AG
MedicalResearch.com: What are the main findings of the study?Prof. Bhopal:In a randomised controlled trial, a tailored, family orientated intervention whereby dietitians worked in the family home to provide diet and exercise advice in people at high risk of developing diabetes, had a modest but potentially important effect in reducing weight at the end of the three-year intervention, by 1.6 kg more than in the control group.
MedicalResearch.com Interview with:Catherine H. Mercer Ph.D.
UCL Centre for Sexual Health & HIV Research
Research Department of Infection & Population Health
University College London London U.K.
MedicalResearch.com: What are the main findings of the study?Dr. Mercer: Firstly, the National Surveys of Sexual Attitudes and Lifestyles, Britain’s nationally-representative surveys of sexual behaviour (or Natsal for short), have captured substantial changes in sexual attitudes and lifestyles over the past 60 years, having collected data from over 45,000 people born between the 1930s and the 1990s – a period spanning much of the 20th Century.
Secondly, the recent changes in behaviour that we have observed - so over the past decade - have however been considerably more marked for women than men, with the gender gap in reported behaviour narrowing, and in some cases, disappearing altogether.
Thirdly, we’ve seen a greater acceptance of more diverse sexual lifestyles, such as same-sex sexual partnerships, but greater intolerance of what many people might consider as ‘disrespectful’ sexual partnerships, including non-exclusivity in marriage.
MedicalResearch.com Interview with:Dr Kirstin R Mitchell PhD
Lecturer in Sexual and Reproductive Health
Dept of Social and Environmental Health Research
Faculty of Public Health & Policy
London School of Hygiene and Tropical Medicine
MedicalResearch.com: What are the main findings of the study?Dr. Mitchell: We explored the distribution of sexual function in the British population using a probability sample survey (the third National Survey of Sexual Attitudes and Lifestyles [Natsal-3]) of 15 162 individuals aged 16–74 years. We measured sexual function using the Natsal-SF, a novel validated measure, which assessed problems with individual sexual response, sexual function in a relationship context, and self-appraisal of sex life.
Men and women in the oldest age groups surveyed (55 – 74) were more likely to have low overall sexual function than those in the youngest age group (16 – 24). After taking account of age differences, low sexual function was associated in both men and women with being unemployed, with current depression, and with poor general health. It was also associated with higher numbers of lifetime partners (women only), paying for sex (men only), and reporting same-sex partners, as well as with other aspects of sexual health, such as being diagnosed with an STI and experiencing sex against their will.
Low sexual function was associated with relationship breakdown, and with people not being happy with their relationship. Within relationships, the most common problem was an imbalance in level of interest in sex between partners, which affected around a quarter of both men and women. Just under one in five men and women said their partner had experienced sexual difficulties in the last year, and this proportion increased with age, particularly among women.
Lack of interest in sex was one of the most commonly reported problems for both men and women, affecting three in every twenty (15%) men, and with women twice as likely as men to say that this had been an issue in the last year. Difficulty reaching climax (16%) and vaginal dryness (13%) were among common problems for women; and reaching a climax more quickly than desired (15%), and difficulty getting or keeping an erection (13%) among men.
MedicalResearch.com Interview with:Dr Nigel Field MBPhD
Research Department of Infection and Population Health
University College London, London, UK
MedicalResearch.com: What are the main findings of the study? Dr. Field:This study, published in The Lancet on Tuesday 26 November, reports data from the third National Survey of Sexual Attitudes and Lifestyles (Natsal), interviewing over 15,000 participants aged 16-74 years, to systematically assess the association between people’s health and their sexual lifestyles in Britain. The key findings from the study are that close to one in six (17%) of men and women feel that their health had affected their sex life in the past year. This rises to three fifths (60%) among men and women who say that they are in bad health. However, only a quarter of men (24%) and under a fifth of women (18%) who say that ill-health affects their sex life had sought help from a health profession, usually a family doctor.
MedicalResearch.com Interview with:Professor Clive Page
Director, Sackler institute of Pulmonary Pharmacology
Joint Head, Institute of Pharmaceutical Science
King's College London
150 Stamford Street Waterloo Campus
London SE1 9NH
MedicalResearch.com: What are the main findings of the study?Prof. Page: RPL 554 was shown to cause bronchodilation and anti-inflammatory activity at the same dose. The drug showed benefit in both patients with COPD and asthma.
MedicalResearch.com Interview with:Prof Eric Lawitz MD
Vice President of Scientific and Research Development at The Texas Liver Institute
Clinical professor of Medicine
San Antonio University of Texas Health Science Center.
MedicalResearch.com: What are the main findings of the study?Dr. Lawitz: Currently available treatments for HCV involve weekly injections of pegylated interferon and daily doses of oral antivirals that must be taken for up to a year. These regimens are not only burdensome for patients, but are not always effective and can cause serious and debilitating side effects, including anemia. So there is a significant need for new tablet-based treatment regimens for HCV that eliminate interferon and ribavirin, are more effective, better tolerated and easier for patients to take.
MedicalResearch.com Interview with:Dr. Kelly K. Hunt, M.D., F.A.C.S.
Professor, Department of Surgical Oncology, Division of Surgery
Chief, Breast Surgical Oncology Section, Department of Surgical Oncology
The University of Texas MD Anderson Cancer Center, Houston, TX
MedicalResearch.com: What are the main findings of the study?Dr. Hunt: The primary endpoint of the Z1041 trial was the proportion of patients who had pathological complete response in the breast, defined as the percentage of women who started the neoadjuvant treatment with no histological evidence of disease in the breast at surgery. We found that high pathologic response rates were observed in both treatment groups with similar cardiac safety profiles in both arms of the trial. Specifically, 56.5% of patients in the sequential group (fluorouracil, epirubicin and cyclophosphamide on day one of a 21-day cycle for four cycles followed by paclitaxel plus trastuzumab weekly for 12 weeks) had a complete pathological response versus 54.2% of the patients who received the concurrent regimen (paclitaxel and trastuzumab weekly for 12 weeks followed by fluorouracil, epirubicin and cyclophosphamide on day one of a 21-day cycle with trastuzumab on days one, eight and 15 of the 21-day cycle for four cycles). The difference in pathologic complete response rates between the treatment arms was not statistically significant. Cardiac safety was a secondary endpoint of the trial and we found that both regimens had acceptable cardiac safety profiles.
MedicalResearch.com Interview with:Prof David K Menon MD PhD FRCP FRCA FFICM FMedSci
Head, Division of Anaesthesia, University of Cambridge Consultant,
Neurosciences Critical Care Unit BOC Professor,
Royal College of Anaesthetists
Professorial Fellow, Queens' College, Cambridge
Senior Investigator, National Institute for Health Research
Box 93, Addenbrooke's Hospital, Cambridge CB2 2QQ, UK
MedicalResearch.com: What is the background for your study?Dr. Menon:We have known for some time that a history of traumatic brain injury (TBI) results in a significant (between 2 and 10 fold) increase in the likelihood of getting dementia in later life. On possible mechanistic explanation for this comes from the finding that about a third of individuals who died of TBI, regardless of age, are found at autopsy to have deposits of β-amyloid in the brain, often Aβ42, which is the same variant of amyloid seen in the brain of patients who have Alzheimer’s Disease.
However, such detection after death has made it impossible to examine the linkage of such early amyloid deposition to late dementia. More recently, imaging with positron emission tomography (PET) and Pittsburgh compound B (PIB) has been used to image amyloid deposits in Alzheimer’s Disease. However, the technique had not been validated in traumatic brain injury.
MedicalResearch.com Interview with:Prof Jayant S Vaidya PhD
Clinical Trials Group, Division of Surgery and Interventional Science
University College London, London, UK
MedicalResearch.com: What are the main findings of the study?Dr. Vaidya:The main findings are
a) these are longer term results that have confirmed our original publication in 201
(b) We found that when TARGIT intraoperative radiotherapy is given at the time of lumpectomy for breast cancer, the local control and survival from breast cancer is similar to several weeks of whole breast radiotherapy
c) we also found that with TARGIT there are significantly fewer deaths from other causes - i.e., fewer deaths from cardiovascular causes and other cancers
MedicalResearch.com Interview with:Dr. Colin Derdeyn
Mallinckrodt Institute of Radiology and the Departments of Neurology and Neurosurgery
Washington University School of Medicine, St Louis, MO, USA
MedicalResearch.com: What are the main findings of the study? Dr. Derdeyn: The primary results indicate that medical management, consisting of dual antiplatelets for 3 months after a transient ischemic attack (TIA) or stroke, and rapid, effective control of blood pressure (systolic BP less than 140 mm Hg and 130 mm Hg if diabetic) and LDL-cholesterol (less than 70 mg/dl), in addition to management of other risk factors, is superior to angioplasty and stenting in addition to the same medical regimen for reducing the risk of future stroke in patients with severe atherosclerotic stenosis (>70%) of a major intracranial artery. In addition, while there were subgroups at higher risk for stroke on medical treatment (older age, female gender, prior stroke in the territory), none of these subgroups appeared to have a benefit from stenting (i.e. stroke rates in the stenting groups in these subgroups was higher too).
MedicalResearch.com Interview with :Dr Belén Pedrique
Drugs for Neglected Diseases initiative
DNDi, 15 Chemin Louis Dunant
1202 Geneva, Switzerland
MedicalResearch.com : What are the main findings of the study?Dr. Pedrique: Of the 850 new drugs and vaccines approved for all diseases in 2000-2011, 4% (37) were for neglected diseases, defined broadly as those prevalent primarily in poor countries: malaria, tuberculosis, 17 neglected tropical diseases (NTDs) as defined by the World Health Organization (WHO), 11 diarrheal diseases, and 19 other diseases of poverty, excluding HIV/AIDS. Globally these neglected diseases represent an 11% health burden, based on a recent assessment of 2010 disability-adjusted life-years (DALYs).
Most newly developed therapeutic products were repurposed versions of existing drugs. Of the 336 brand-new drugs (new chemical entities, or NCEs) approved for all diseases in 2000-2011, only four, or 1%, were for neglected diseases; three were for malaria, and one for diarrheal disease. None were for any of the 17 WHO-listed NTDs
Of 148,445 phase I-III clinical trials registered as of Dec 31, 2011, only 1% (2,016) were for neglected diseases.
MedicalResearch.com Interview with :Prof Didier Pittet, MD, MS
Director of the Infection Control Programme and WHO Collaborating Centre on Patient Safety, University of Geneva Hospitals, Geneva, Switzerland
MedicalResearch.com : What are the main findings of the study?Prof. Pittet: The main finding is that the WHO hand hygiene promotion strategy is feasible and sustainable across healthcare settings worldwide. For the first time, we have evidence of its feasibility and successful effects to improve hand hygiene in a variety of different geographical and income settings, with an even greater impact in low-/middle-income countries than in high-income countries.
MedicalResearch.com Interview with Dr. Ethan Basch MD
Memorial Sloan-Kettering Cancer Center
MedicalResearch.com: What are the main findings of the study?Dr. Basch: The primary clinical finding of this study is that treatment with abiraterone acetate delays the time until pain develops or worsens in men with advanced prostate cancer. Furthermore, abiraterone delays the time until quality of life and functioning deteriorate, compared to placebo. There is also a broader research finding of this study, which is that it is feasible to rigorously study the time until symptom progression in cancer clinical trials, which paves the way for future studies to use a similar approach.
Dr. Chris Bullen MBChB MPH PhD FAFPM FNZCPHM Director
School of Population Health, The University of Auckland
Private Bag 92019 Auckland 1142, New Zealand
Co-Director of the NZ Tobacco Control Research Turanga: A national programme of research to inform rapid smoking prevalence reduction.
Web: http://www.turanga.org.nz/ MedicalResearch.com: What are the main findings of the study?Dr. Bullen:
E-cigarettes, with or without nicotine, were modestly effective at helping smokers to quit, with similar levels of abstinence as with nicotine patches, and few adverse events.
?At 6 months, verified abstinence was 7·3% with nicotine e-cigarettes, 5·8% with patches, and 4·1% with placebo e-cigarettes. However, there was insufficient statistical power to conclude superiority of nicotine e-cigarettes to patches or to placebo e-cigarettes.
No significant differences in rates of adverse events occurrence were found between the groups.
E-cigarettes, like the vapes found at MagicVaporizers, were very popular throughout the trial, with almost 90% of users stating they would recommend them to a friend trying to quit smoking.
MedicalResearch.com Interview with: Prof Aron Goldhirsch
Department of Medicine
European Institute of Oncology
Via Ripamonti 435, 20141 Milan, Italy
MedicalResearch.com: What are the main findings of the study?Prof. Goldhirsch: Two years of adjuvant trastuzumab after standard chemotherapy is not more effective than is 1 year of treatment with the drug for patients with HER2-positive early breast cancer.
MedicalResearch.com Interview with: Prof John R Yarnold
Division of Radiotherapy and Imaging
The Royal Marsden NHS Foundation Trust
Sutton, Surrey SM2 5PT, UK
MedicalResearch.com: What are the main findings of the study?Prof. Yarnold: A 3-week schedule of curative post-operative radiotherapy for women with breast cancer involving 15 treatments (fractions) delivered Monday to Friday each week, is at least as safe and effective as historical schedules given over 5 or 6 weeks. In fact the 3-week schedule is gentler on the healthy tissues than earlier standard regimens.
MedicalResearch.com Interview with: Prof Sally K Tracy DMid
Midwifery and Women's Health Research Unit
University of Sydney, Royal Hospital for Women
Randwick, NSW, Australia
MedicalResearch.com: What are the main findings of the study?
Prof. Tracy: We recruited 1748 pregnant women, of all risk types, from two tertiary teaching hospitals in different states in Australia and allocated them to receive either caseload midwifery care (871) or standard maternity care (877).
The study found more women in caseload midwifery experienced an unassisted vaginal birth without pharmacological analgesia, and fewer women experienced an elective caesarean. While the trial findings did not show a statistically significant difference in the rate of caesarean sections between either group, the overall rate fell by more than 20 percent from pre-trial levels.
Newborn infants in both groups achieved similar physical assessment scores (Apgar scores). A slightly lower number of pre-term births and neonatal intensive care admissions among the midwifery caseload group was not statistically significant.
Important secondary findings of the study include:
30 percent more spontaneous onset of labour
less induction of labour
less severe blood loss, and
stronger likelihood of breastfeeding at discharge from hospital.
These small differences accounted for an overall difference of AU$566.74 less with caseload midwifery than with standard care.
Caseload midwifery appeared to alter some of the pathways that recurrently contribute to increased obstetric intervention. Having this level of continuity of care works on the assumption that women will labour more effectively, need to stay in hospital less time and feel a stronger sense of satisfaction and personal control if they have the opportunity to get to know their midwife at the beginning of pregnancy. (more…)
Prof. Steve Allen
Professor of Paediatrics and International Health; RCPCH International Officer and David Baum Fellow
Room 314, The College of Medicine, Swansea University,
Swansea, SA2 8PP, UK.
MedicalResearch.com: What are the main findings of the study?Answer: Overall, diarrhoea occurred in just over 10% participants and diarrhoea caused by C. difficile in about 1%. These outcomes were equally common in those taking the microbial preparation and those taking placebo.
Other outcomes (e.g. common GI symptoms, length of hospital stay, quality of life) were also much the same in the two groups. So, there was no evidence that the microbial preparation had prevented diarrhoea or had led to any other health benefit.
In agreement with previous research, serious adverse events were also similar in the two groups – so we found no evidence that the microbial preparation caused any harm.
MedicalResearch.com Interview with: Evelyn Wong MBBS (Hons) MPH PhD CandidateBaker IDI Heart and Diabetes Institute
Level 4, 99 Commercial Rd, Melbourne. VIC 3004
MedicalResearch.com: What are the main findings of the study?Answer: Researchers at Baker IDI Heart and Diabetes Institute reviewed previously published literature on the association between diabetes and the risk of developing physical and functional disability. In this study, disability was defined by a person’s difficulty walking; carrying out daily activities such as using a telephone or transport, managing finances, shopping; or attending to basic self-care needs such as eating, dressing and bathing. Although there have been many previous studies on diabetes and disability, the findings have varied and to date, no one has pooled all studies together for a combined measure of risk. From 26 relevant studies, we measured the pooled effect of the association between diabetes and disability. We found that diabetes increased the risk of disability by 50-80% compared to those without diabetes and this result was consistent across all types of disability. (more…)
MedicalResearch.com Interview with: Ole Raaschou-Nielsen, MSc, PhD
Head of Research Group for Work, Environment & Cancer
Danish Cancer Society Research Center
2100 Copenhagen Ø
MedicalResearch.com: What are the main findings of the study?Answer: The study shows that people who live at locations with higher levels of particles in the air are at higher risk for development of lung cancer.
It seems that there is no threshold for air pollution with particles below which there is no risk; the results show that it is more like “the more air pollution the worse and the less pollution the better”.
The strongest association was seen for adenocarcinoma of the lung.
MedicalResearch.com Interview with:Professor John Zajicek
Professor of Clinical Neuroscience, Centre for Clinical Trials & Health Research - Translational & Stratified Medicine (Peninsula Schools of Medicine and Dentistry)
MedicalResearch.com: What are the main findings of the study?Prof. Zajicek: Our study investigated whether dronabinol (one of the major active ingredients of cannabis) may slow the progression of multiple sclerosis. We currently have no treatments that are effective in modifying the disease course in people with either primary or secondary MS. We did a clinical trial across the UK involving nearly 500 patients, who were randomly allocated to dronabinol or placebo, and followed them up for three years to look at progression on rates. Overall we failed to find an effect of dronabinol on disease progression, either clinically (using a variety of clinical measures) or using magnetic resonance imaging (MRI). There was a suggestion of an effect in people with the least disability (who didn't need a stick to help them walk), and there were no major problems with serious side effects. However, over all the population that took part in the study also progressed less than we expected, which reduced our chances of finding an effect of treatment. The study was not designed to investigate an effect on MS-related symptoms (such as pain and muscle stiffness), which have been investigated before.
MedicalResearch.com Interview with:Daniel Belsky, PhDNIA Postdoctoral Fellow
Center for the Study of Aging and Human Development
Polygenic risk and the development and course of asthma: an analysis of data from a four-decade longitudinal studyMedicalResearch.com: What are the main findings of the study?Dr. Belsky :We looked to the largest-ever genome-wide association study of asthma (that study by the GABRIEL Consortium included more than 26,000 individuals) to identify genetic variants that could be used to construct a genetic profile of asthma risk. We then turned to The Dunedin Multidisciplinary Health and Development Study, a unique cohort of 1,000 individuals who have been followed from birth through their fourth decade of life with extensive measurements of asthma and related traits. We computed a “genetic risk score” for each person based on the variants identified in GWAS. Then, we looked at who developed asthma, when they developed asthma, and what that asthma looked like in terms of allergic response and impaired lung function.
What we found:
(1) People with higher genetic risk scores were more likely to develop asthma and they developed asthma earlier in life.
(2) Among children who developed asthma, the ones at higher genetic risk were more likely to have persistent asthma through midlife.
(3) Genetic risk was specifically associated with allergic asthma that resulted in chronic symptoms of impaired lung function.
(4) People with higher genetic risk score developed more severe cases of asthma. As compared to people with a lower genetic risk, they were more often absent from school and work because of asthma and they were more likely to be hospitalized for asthma.
(5) The genetic risk score provided new information about asthma risk that could not be obtained from a family history.
MedicalResearch.com Interview with: Dr David Strain, MRCP MD
Clinical senior lecturer and honorary consultant
University of Exeter Medical School
Institute of Biomedical and Clinical Science
Department of Diabetes and Vascular Research
Royal Devon & Exeter Hospital Exeter EX2 5AX
MedicalResearch.com: What is the Background of the study?
In early 2010 recent diabetes outcome trials such as ACCORD and ADVANCE had put into question the benefit of aggressive HbA1c reduction for all patients particularly in elderly population. After that there were several guidelines that suggested individualizing treatment targets for elderly patients according to their age, co-morbidities, frailty and baseline HbA1c. This featured in the Finnish guidelines and the European Working Party for the management of Diabetes in the Older Person. However this was also completely without any evidence base. I worked with Paivi Paldanius (the final author of the paper and a medical advisor for Novartis) to establish a pragmatic study. We both acknowledged the importance of having a patient-centric, pragmatic and 'real-life' approach and as there was already evidence that DPP-4 inhibitors, in this case vildagliptin (due to Päivi's affiliation), had demonstrated it's efficacious and had no tolerability issues in the elderly population we decided to go ahead with the study.
It was obvious that we needed to implement a holistic approach and take into account as many clinically relevant parameters as possible, such as age, baseline HbA1c, duration of the disease, co-morbidities and frailty, for implementation of the individualized care. Our primary goal was to request that the physicians acting as investigators would still apply their clinical judgment based on these clinical features of each individual patient but also, follow their local guidelines as in their daily clinical practice. This would later provide us with invaluable information and perspective when interpreting the data and recommending implementation of the results. For assessment of frailty we screened for many different methodologies but Prof Timo Strandberg (known expert of the field and mentioned in the acknowledgements section of our paper) suggested to apply modified Linda Fried's method for assessment of phenotype of frailty as this method is validated, very pragmatic, reproducible and also feasible to be used for the first time also by a non-geriatric investigator. All investigators were trained to follow these parameters by the protocol. We also wished to evaluate in parallel the conventional HbA1c drop assessment in order to be able to put the potential success of our new endpoint, meeting the individualized target, into perspective and for comparison against other standard data from other studies with DPP-4 inhibitors with elderly. We also wished to simulate a clinical, real-world setting as much as possible and included patients who would seem representative of most elderly T2DM patients.
MedicalResearch.com Interview with:Dr Patrick Freund
Spinal Cord Injury Center Balgrist
University Hospital Zurich, University of Zurich
8008 Zurich, Switzerland
MedicalResearch.com: What are the main findings of the study?Dr. Freund: Novel interventions targeting acute spinal cord injury (SCI) have entered clinical trials, but neuroimaging biomarkers reflecting structural changes within the central nervous system are still awaited. In chronic SCI, neuroimaging provided evidence of structural changes at spinal cord and brain level that could be related to disability. However, the pattern and time course of these structural changes and their potential to predict clinical outcomes is uncertain.
In a prospective longitudinal study, thirteen patients with acute traumatic SCI were assessed clinically and by longitudinal MRI (within five weeks of injury, after two, six and twelve months) and were compared to eighteen healthy controls. Cross-sectional cord area, cranial white matter (CST) and grey matter (cortex) volume decrease was evident at baseline and progressed over twelve months. Multi-parametric mapping of myelin sensitive magnetization transfer (MT) and longitudinal relaxation rate (R1) was reduced both within and beyond the areas of atrophic changes. Better neurological and functional outcomes were associated with less atrophic changes of the CST in both cord and brain.
Deputy Director of the Jiangsu Provincial Center for Disease Prevention and Control,
Jiangsu provincial center for disease prevention and control
MedicalResearch.com Editor's Note:
Hand Foot and Mouth Disease
MedicalResearch.com: What are the main findings of the study?
Answer: From this trial, the inactivated alum-adjuvant EV71 vaccine showed a good protection for both the EV71-associated HFMD and EV71-associated disease. The vaccine gave 90% protection against clinical EV71-associated HFMD and 80.4% against EV71-associated disease (including neurological complications) for at least 12 months. The safety profile and immunogenicity of this vaccine is proved to be clinical acceptable. We also proposed a titre (1:32) of neutralization antibody as surrogate of protection against EV71-associated disease.
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