Published on March 14, 2014
MedicalResearch.com Exclusive Interviews with Medical Research and Health Care Researchers Editor: Marie Benz, MD email@example.com March 14 2014 For Informational Purposes Only: Not for Specific Medical Advice.
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HPV Vaccination and Prevention of Cervical Abnormalities MedicalResearch.com Interview with: Dr Julia Brotherton Victorian Cytology Service, Melbourne, Victoria, Australia Dr Elizabeth Crowe The University of Queensland, School of Population Health, Brisbane, Australia Prof. David Whiteman Group Leader / Department Coordinator QIMR Berghofer Medical Research Institute Royal Brisbane Hospital, QLD 4029 • MedicalResearch.com: What are the main findings of the study? • 1. We conducted a case-control study in which we retrieved the HPV vaccination histories of young Australian women who were notified to the Pap smear registry with high-grade cervical lesions or with other types of cervical lesions, and compared them with the vaccination histories of women whose Pap smears showed only normal cytology. • 2. We found that women with high grade cervical lesions were significantly less likely than women with normal cytology to have received 3 doses of the quadrivalent HPV vaccine, equivalent to a vaccine effectiveness of 46%. • 3. The vaccine effectiveness among 15-19 year old women was even higher at 57%. We believe this reflects the fact that HPV16 causes an even higher proportion of high grade disease in young women due to its higher oncogenicity and shorter latent period. • 4. The HPV vaccine had 34% effectiveness against other cervical lesions (i.e. those not proven to be high grade lesions on histology). • 5. We also observed that 2 doses of the vaccine were 21% effective in preventing both high grade lesions and other grade lesions. MedicalResearch.com: Were any of the findings unexpected? • 1. Before this study was performed, we did not know whether less than three doses of vaccine would provide any protection. Our findings that 2 doses conferred 21% protection against both high grade lesions and other lesions are encouraging, but suggest that three doses are required for best protection using the current dose schedule. • MedicalResearch.com: What should clinicians and patients take away from your report? • 1. This report demonstrates the effectiveness of the HPV vaccine in the ‘real world’ population setting (i.e. outside of clinical trials). • 2. The vaccine is targeted against two HPV types (16 and 18) that are known to cause about 50% of high grade cervical lesions. Among women receiving the vaccine, we observed a 46% reduction in the risk of high grade lesions, consistent with the vaccine preventing almost all high grade lesions that are caused by HPV 16 and 18. • 3. Importantly, because the vaccine does not target other HPV types known to cause the remainder of high grade lesions, it is essential that women continue to be screened, even if they have received the vaccine. Read the rest of the interview on MedicalResearch.com
HPV Vaccination and Prevention of Cervical Abnormalities MedicalResearch.com Interview with: Dr Julia Brotherton Victorian Cytology Service, Melbourne, Victoria, Australia Dr Elizabeth Crowe The University of Queensland, School of Population Health, Brisbane, Australia Prof. David Whiteman Group Leader / Department Coordinator QIMR Berghofer Medical Research Institute Royal Brisbane Hospital, QLD 4029 • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • 1. We need to continue to monitor trends in HPV vaccination rates, and also closely monitor trends in cervical lesions and cancers into the future as it is predicted that vaccine effectiveness will be seen to improve with longer follow-up times. • 2. The performance of the Pap smear programs must be monitored to rapidly flag any changes in screening practices among women. • 3. While we estimated the effectiveness of 2 doses of the vaccine as 21%, this needs to be confirmed in other studies. • Citation: • Effectiveness of a quadrivalent human papillomavirus vaccine for the prevention of cervical abnormalitites MJ 2014; 348 doi: http://dx.doi.org/10.1136/bmj.g1458 (Published 4 March 2014) • Cite this as: BMJ 2014;348:g1458 Read the rest of the interview on MedicalResearch.com
Atrial Fibrillation, Warfarin and Kidney Function after Heart Attack MedicalResearch.com Interview with: Juan Jesus Carrero PhD (Pharm and Med) Associate Professor in Renal Medicine Karolinska Institutet, Sweden. • MedicalResearch.com: Why did you choose to study this particular question? • Answer: We chose this question because there is currently an important knowledge gap regarding safety and effectiveness of common drugs in individuals with chronic kidney disease. Because kidney dysfunction interferes with drug metabolism and drug elimination, patients with kidney dysfunction have traditionally been excluded from randomized controlled trials. Yet, practice guidelines are afterwards extrapolated to those in the absence of formal evaluation. • MedicalResearch.com: Tell us about your study…. What did you set out to discover? • Answer: We studied outcomes associated to warfarin treatment in patients with both atrial fibrillation and kidney disease. These individuals are at a markedly increased risk of bleeding and ischemic stroke. Although such patients have a clear indication for anticoagulant therapy, recent observational studies in advanced chronic kidney disease have provided conflicting results, suggesting that warfarin treatment may instead confer harm. • Our study considered all consecutive Swedish patients with Atrial Fibrillation admitted to the hospital for an acute myocardial infarction. Because of availability of creatinine assessments, we were able to estimate the severity of underlying chronic kidney disease. Our pre-specified outcomes were the composite of death, myocardial infarction and stroke, as well as the risk of bleeding, within one year from discharge date. • MedicalResearch.com: What were your findings? • Answer: We observed that more than 50% of the included patients were considered to have chronic kidney disease, evidencing the commonness of kidney dysfunction in individuals with cardiovascular disease. • Our main finding was that warfarin treatment was associated with a lower risk for the composite outcome without increased risk of bleeding. This was observed not only for individuals with normal kidney function but also for those with moderate, severe or end-stage kidney disease. • MedicalResearch.com: What are the implications of the study findings? • Answer: Our study may therefore suggest that patients with Atrial Fibrillation and renal disease not requiring dialysis can also benefit from warfarin therapy and thus should not be excluded from this treatment option. • MedicalResearch.com: What additional research is needed? • Answer: This study includes individuals with kidney disease not requiring dialysis. The evaluation of warfarin safety in dialysis patients still is not fully established. Finally, because ours is an observational study, further clinical trials are necessary to definitely answer this question. • Citation: • Warfarin, Kidney Dysfunction, and Outcomes Following Acute Myocardial Infarction in Patients With Atrial Fibrillation • Juan Jesús Carrero PhD(Pharm and Med), Marie Evans MD, PhD, Karolina Szummer MD, PhD, Jonas Spaak MD, PhD, Lars Lindhagen PhD, Robert Edfors MD, Peter Stenvinkel MD, PhD, Stefan H Jacobson MD, PhD, Tomas Jernberg MD, PhD • JAMA. 2014;311(9):919-928. doi:10.1001/jama.2014.1334 Read the rest of the interview on MedicalResearch.com
Hepatitis C: About 1% US Population Infected MedicalResearch.com Interview with: Scott D. Holmberg, MD, MPH Chief, Epidemiology and Surveillance Branch Division of Viral Hepatitis. • MedicalResearch.com: What are the main findings of the study? • Dr. Holmberg: Based on interview and testing of over 30, 000 National Health and Nutrition and Examination Survey (NHANES) participants from 2003 to 2010, 273 US residents or about 1%, are chronically (actively) infected with hepatitis C virus (HCV). This translates to about 2.7 million chronic HCV-infected persons in the non-institutionalized population. • MedicalResearch.com: Were any of the findings unexpected? • Dr. Holmberg: This analysis indicated that the number of chronically infected persons are about 500,000 fewer than a similar NHANES analysis done between 1999 and 2002. This may be related to statistical variation between the two samples, or, as we have observed, increasing mortality in HCV-infected patients. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Holmberg: Hepatitis C virus is a widely prevalent infection that causes more morbidity and mortality than most other infectious diseases. Because of the long incubation period between infection and overt disease—often 20, 30, or more years—infected patients and even clinicians may be inclined to dismiss HCV as an indolent, even benign infection. This study underscores the importance of CDC and US Preventive Services Task Force recommendations that all persons born between 1945 and 1965, about 75% of all cases, should get tested at least once for hepatitis C virus. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Holmberg: This analysis needs to be repeated in future years as an important index and measure of trends in chronic hepatitis C. • Citation: • Chronic Hepatitis C Virus Infection in the United States, National Health and Nutrition Examination Survey 2003 to 2010 • Ann Intern Med. 2014;160(5):293-300-300. doi:10.7326/M13-1133 • Maxine M. Denniston, MSPH; Ruth B. Jiles, PhD, MS, MPH; Jan Drobeniuc, MD, PhD; R. Monina Klevens, DDS, MPH; John W. Ward, MD; Geraldine M. McQuillan, PhD; and Scott D. Holmberg, MD, MPH Read the rest of the interview on MedicalResearch.com
Herbal Cannabis Not Proven Effective For Rheumatic Diseases MedicalResearch.com Interview with: Mary-Ann Fitzcharles, MB, ChB, MRCP(UK), FRCP(C) McGill University Health Centre Division of Rheumatology and Alan Edwards Pain Management Unit • MedicalResearch.com: What are the highlights of your review? • Dr. Fitzcharles: Thank you for your interest in the review article which will shortly be published in Arthritis Care & Research. This was not a research study but rather a review focused towards the use of herbal cannabis for patients with rheumatic diseases. • The essence of our message after a thorough review of the literature is that there is not a single study published regarding efficacy or side effects of herbal cannabis in the rheumatic diseases. It is notable that almost 2 thirds of persons using herbal cannabis for therapeutic reasons report use for musculoskeletal complaints. In the 21st century, we cannot rely upon heresay or anecdote to justify use of a treatment intervention. It is unacceptable to recommend use of a substance without knowledge of concentration of molecules in the product, any knowledge of blood concentrations that might have a positive or negative effect, and formal study in defined patient populations with acceptable endpoint criteria and evidence for short and long term risks. • With the knowledge of short and long term risks that are emerging from study of recreational user, we recommend that the herbal product should only be used in the extreme and very rare situation when a patient with rheumatic disease is suffering severe pain that has been unresponsive to trials of standard medical therapy. • Citation: • The Dilemma of Medical Marijuana Use by Rheumatology Patients • Mary-Ann Fitzcharles, Daniel J. Clauw, Peter A. Ste-Marie and Yoram Shir Arthritis Care and Research Accepted manuscript online: 3 MAR 2014 07:30AM EST | DOI: 10.1002/acr.22267 Read the rest of the interview on MedicalResearch.com
Obesity Rates Triple in Canada Over 25 Years MedicalResearch.com Interview with: Dr. Laurie K. Twells, PhD School of Pharmacy, Memorial University, St. John’s Faculty of Medicine, Memorial University St. John’s Newfoundland and Labrador • MedicalResearch.com: What are the main findings of the study? • Dr. Twells: Obesity rates in Canada tripled between 1985 and 2011. Although class I obesity (BMI ≥ 30) appears to have increased at a slower rate, obese classes II (BMI ≥ 35) and III (BMI ≥40) continued to increase disproportionately. Over the last decade, every province in Canada experienced increases in obesity rates. Overall obesity rates were lower in the west and higher in the eastern provinces and people over age 40 years were more likely to be overweight/obese than younger people. By 2019 it is projected that twenty-one per cent of Canadians will be obese but this will vary by province from 15.7% in British Columbia to 34.6% in Newfoundland and Labrador. • MedicalResearch.com: Were any of the findings unexpected? • Dr. Twells: The provincial comparisons in Canada were interesting and presenting the data in this format uncovered the differences in obesity rates (current and predicted) across the country. The predicted prevalence rates for some provinces are very concerning given the health system burden and impact on quality of life associated with being in the excessive weight categories. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Twells: In Canada, the number of individuals with a BMI greater than 35 and 40 are predicted to increase over the next five years. These individuals are at a much higher risk of developing serious comorbid conditions such as hypertension, dyslipidemia, diabetes, reporting impaired quality of life and dying prematurely. Clinicians will need to be resourced to manage and treat affected individuals effectively. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Twells: One area for future research is the need to help explain why such significant inter-provincial variations exist in Canada. This might include a focus on evaluating existing provincial policies, programs and approaches to the prevention, management and treatment of obesity. For example, provincial variation exists in the provision of bariatric surgery, the training or lack of training of health professionals in weight management and in patient access to other types of expertise in weight loss such as dieticians and psychologists. There is the potential in Canada for provinces to share effective practices to improve the overall health of the country. • Citation: • Current and predicted prevalence of obesity in Canada: a trend analysis • Laurie K. Twells PhD, Deborah M. Gregory PhD, Jacinta Reddigan MSc, William K. Midodzi PhD cmajo 2:E18-E26; published online March 3, 2014, doi:10.9778/cmajo.20130016 Read the rest of the interview on MedicalResearch.com
Hospital Mortality: Association With Nurses’ Work Load and Education MedicalResearch.com Interview with: Professor Linda H Aiken PhD, FAAN, FRCN, RN Claire M. Fagin Leadership Professor in Nursing, Professor of Sociology Director of the Center for Health Outcomes and Policy Research Center for Health Outcomes and Policy Research University of Pennsylvania School of Nursing • MedicalResearch.com: Austerity measures and health-system redesign to minimise hospital expenditures risk adversely affecting patient outcomes. Against that backdrop, can you start by letting us know the background of the study? • Prof. Aiken: European Surgical Outcomes Study in 28 countries showed higher than necessary deaths after surgery. • A comparable study in the US showed that despite the nation spending hundreds of millions of dollars on improving patient safety, there were no improvements in adverse outcomes after surgery in US hospitals between 2000 and 2009. Clearly it is time to consider new solutions to improving hospital care for surgical patients, who make up a large proportion of all hospital admissions. Our study was designed to determine whether there are risks for patients of reducing hospital nurse staffing, and what, if any, are the benefits to patients of moving to a more educated nurse workforce. • MedicalResearch.com: Could you tell us a little about what the average workload of nurses were in the countries you studied is? • Prof. Aiken: The average patient to nurse ratio in hospitals in the 9 countries is 8.3 patients per nurse (which compares to about 5.5 in the USA) but these ratios varied from hospitals in which nurses care for 3 patients each to others where nurses care for 18 patients each. On average nurses’ workloads are lowest in Norway and highest in Spain but within every country there is substantial variation in hospital nurse staffing. In England with a national health service where standardization might be expected, the workloads of nurses in some hospitals were double those of others, ranging from 5 patients per nurse to over 11 patients per nurse. It is this difference in nurse staffing levels across hospitals within every country that contributes to what we found to be a 7-fold difference in death rates after surgery for similar kinds of patients. We found every one patient increase in a nurses work load was associated with a 7% increase in the risk of death for patients– which illustrates the hazards of increasing nurses’ workloads in attempts to save money. These findings in Europe mirror the findings of papers we have published on nurses and mortality in the USA. Read the rest of the interview on MedicalResearch.com
Hospital Mortality: Association With Nurses’ Work Load and Education MedicalResearch.com Interview with: Professor Linda H Aiken PhD, FAAN, FRCN, RN Claire M. Fagin Leadership Professor in Nursing, Professor of Sociology Director of the Center for Health Outcomes and Policy Research Center for Health Outcomes and Policy Research University of Pennsylvania School of Nursing • MedicalResearch.com: Can you tell us a little more about your findings with regard to nurses’ education? • Prof. Aiken: Generally we think of educational attainment as a characteristic of an individual. But the educational composition of a hospital’s nursing staff is also an attribute of an institution. In Norway and Spain, all nurses must have a bachelor’s degree but in other countries, hospitals may employ nurses with and without university education. There has been a contentious debate within the European Union on standardization of nursing education, and whether the goal of standardization should be the bachelor’s degree as in other professions. Currently two very different levels of education for nurses are recognized within the EU: nurses with 12 years of general schooling plus university education and nurses with only 10 years of general schooling followed by vocational training. Like nurse staffing, the educational composition of nurses in hospitals varies substantially with some hospitals having no nurses with bachelor’s qualifications and some hospitals having 100% bachelor’s qualified nurses. In England, for example, the NHS hospitals studied varied from 10% of bachelor’s educated nurses to 49%. That hospital-level variation in the proportion of nurses with bachelor’s education was significantly associated with patient deaths, after taking into account other possible explanations including nurses’ workloads and how sick the patients were before surgery. We found that every 10% increase in the proportion of nurses in a hospital with bachelor’s qualifications was associated with a 7% decline in patient deaths. The Institute of Medicine of the National Academy of Sciences has acted upon our similar findings in the USA and has proposed that by 2020, at least 80% of USA nurses should hold the bachelor’s degree in nursing. • MedicalResearch.com: Were there any unusual findings you’d like to comment on? • Prof. Aiken: Patients have the highest risk of death after surgery in hospitals where nurses with lower education care for more patients each. • Our most important finding for policymakers and consumers is that there is an unjustifiable difference in death rates following common surgery across hospitals in every country, and differences in nursing resources are a contributing factor to high death rates in many hospitals. • In every country there are well performing hospitals suggesting that even under less than optimal economic circumstances it is possible to achieve a high quality of hospital care. A reasonable strategy to proceed in reducing preventable hospital deaths would appear to be improving nurse staffing in the hospitals in every country where nurses’ workloads are high, and transitioning to bachelor’s education for nurses. • Some might say that university education for nurses is not feasible for a variety of reasons. The fact that both Norway, a well-resourced country, and Spain, a country struggling more to contain spending, could have successfully transitioned to an all university educated nurse workforce suggests that all countries in Europe could make the transition, and our results suggest that such a transition is in the public interest. • MedicalResearch.com: What conclusions can be drawn from your results, and what are the implications for the future? • Prof. Aiken: While our study was immensely complicated to conduct, the conclusions and recommendations are remarkably simple. Modern hospitals exist to provide 24 hour professional nursing care to people too sick to recover at home. Thus it is foolish at best, and fatal at worst to under invest in nursing which is the primary service provided by hospitals. Health reform initiatives and austerity measures, both of which tend to focus on reducing hospital nurses, put patients at serious risk of unnecessary death and other adverse outcomes. • Given the aging of Europe (and the USA), more nurses will be needed in the future. It is unrealistic to expect the best and brightest of next generations to enter careers that do not provide a university education. There won’t be enough talented and committed professional nurses to take on impossible burdens of unreasonable workloads and unsafe patient care. Improving quality of hospital care now and for the future requires serious investments in professional nurses. • Citation: • Aiken LH, Sloane DM, Bruyneel L, Van den Heede K, Griffiths P, Busse R, Diomidous M, Kinnunen J, Kozka M, Lesaffre E, McHugh M, Moreno-Casbas MT, Rafferty AM, Schwendimann R, Tishelman C, van Achterberg T, Sermeus W. 2014. Association of nurse staffing and education with hospital mortality in 9 European countries. The Lancet. http//dx.doi.org/a0.1016/S0140-6738(13)62631-8 February 26, 2014. Read the rest of the interview on MedicalResearch.com
Gaining Prescription Drug Insurance Reduced Inpatient Medicare Payments MedicalResearch.com Interview with: Prof. Robert Kaestner University of Illinois at Chicago – Institute of Government and Public Affairs Chicago, IL 60607 and National Bureau of Economic Research New York, NY 10016-4309 • MedicalResearch.com: What are the main findings of the study? • Prof. Kaestner: Gaining prescription drug insurance through Medicare Part D was associated with a 8% reduction in the probability of a hospital admission, a 7% reduction in Medicare payments for inpatient services per person (who obtained insurance), and a 12% reduction in hospital resource use per person. MedicalResearch.com: What should clinicians and patients take away from your report? • Prof. Kaestner: Prescription drugs are, on average, a substitute for inpatient care. The greater use of prescription drugs that comes with insurance prevents hospitalizations. MedicalResearch.com What recommendations do you have for future research as a result of this study? • Prof. Kaestner: Future research should try to identify the specific biological and clinical mechanisms underlying the finding that prescription drug use decreased hospitalization. • Citation: Kaestner, Robert and Long, Cuiping and Alexander, G. Caleb, Effects of Prescription Drug Insurance on Hospitalization and Mortality: Evidence from Medicare Part D (February 2014). NBER Working Paper No. w19948. Available at SSRN: http://ssrn.com/abstract=2403672 Read the rest of the interview on MedicalResearch.com
After Outgrowing One Food Allergy, Some Patients Develop Second Allergic Reaction to Same Food MedicalResearch.com Interview with: Jonathan M. Spergel, M.D., Ph.D. The Children’s Hospital of Philadelphia Chief, Allergy Section Associate Professor of Pediatrics Perelman School of Medicine at the University of Pennsylvania • MedicalResearch.com: What are the main findings of the study? • Dr. Spergel: We were examining patients with Eosinophilic Esophagitis, an unique food allergy of the esophagus. We found a subset of patients, who in the past had IgE mediated reaction to the food (hives, anaphylaxis) and had outgrown it. Two-three years after outgrowing the food, then the patients developed Eosinophilic Esophagitis to the same food. MedicalResearch.com: Were any of the findings unexpected? • Dr. Spergel: Yes, this finding indicated two important things: • You can get two different reactions to the same food. • The mechanism of the reactions for IgE-mediated reactions and Eosinophilic Esophagitis are different. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Spergel: For patients and clinician, if someone has outgrown the food allergy. But, then gets new symptoms, it could be the food that they had outgrown. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Spergel: This research raises two important questions. • How often does this happen? How many patients that outgrown their food allergy will develop a different reaction to the same food? • Is there a better to treat patients with Eosinophilc Esophagitis or food allergy due to this difference in mechanism? • Citation: • Maggadottir et al, “Development of Eosinophilic Esophagitis to Food after Development of IgE Tolerance to the Same Food, abstract 990, presented March 2, 2014 at the AAAAI Annual Meeting. Read the rest of the interview on MedicalResearch.com
Pneumonia Risk Increased From Sleep Apnea MedicalResearch.com Interview with: Dr. Vincent Yi-Fong Su Department of Chest Medicine Taipei Veterans General Hospital Taipei, Taiwan • MedicalResearch.com: What are the main findings of the study? • Answer: We found interestingly that patients with sleep apnea experienced a 1.20-fold (95% CI, 1.10-1.31; p <0.001) increase in incident pneumonia compared to patients without sleep apnea. We also demonstrated an “exposure-response relationship,” in that the patients with more severe sleep apnea might have a higher risk for pneumonia than did those of milder severity. MedicalResearch.com: What should clinicians and patients take away from your report? • Answer: Based on our results, primary care generalists are suggested to survey sleep disorders among pneumonia patients without other identified risk factors or among patients with recurrent pneumonia. For sleep specialists, our finding may broaden the spectrum of sleep apnea-related complications, which may not limited to the cardiovascular or neurocognitive aspects. As well, while caring CPAP users, every effort should be made to minimize the risk of pneumonia, such as enhanced cleaning of CPAP tubing and humidifier or being vigilant if recurrent pneumonia was noted among CPAP users. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Answer: Future more elaborate prospective research is needed to confirm our finding and elucidate the possible underlying mechanisms. • Citation: • Sleep apnea and risk of pneumonia: a nationwide population-based study • Vincent Yi-Fong Su, Chia-Jen Liu, Hsin-Kai Wang, Li-An Wu, Shi-Chuan Chang,Diahn-Warng Perng, Wei-Juin Su,Yuh-Min Chen, Elizabeth Ya-Hsuan Lin ,Tzeng-Ji Chen and Kun-Ta Chou • CMAJ cmaj.131547; published ahead of print March 3, 2014, doi:10.1503/cmaj.131547 Read the rest of the interview on MedicalResearch.com
Chronic Urticaria: Supplemental Vitamin D3 for Hives Management MedicalResearch.com Interview with: Dr. Jill A Poole MD Pulmonary, Critical Care, Sleep, and Allergy Division, Department of Medicine College of Medicine, University of Nebraska Medical Center The Nebraska Medical Center, Omaha, Nebraska • MedicalResearch.com: What are the main findings of the study? • Dr. Poole: Our study found that adding vitamin D 4000 IU daily to a cocktail of anti-allergy medications resulted in a further 40% reduction in hive symptom scores at 3 months. There was no further reduction in hive symptoms when 600 IU of vitamin D was added to the anti-allergy medications. The anti-allergy regimen utilized was triple drug therapy with cetirizine (twice daily), ranitidine (twice daily), and montelukast (once daily). No adverse reactions occurred. Dr. Poole: Were any of the findings unexpected? • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Poole: Clinicians and patients might want to consider adding 4000 IU of vitamin D with their anti-allergy medications to gain further reduction in hive symptoms. They should note that supplemental vitamin D should be taken for 3 months. Vitamin D has a long half life, meaning, it takes 6-8 weeks to replenish vitamin D stores and/or reach a steady state. Our findings of a beneficial role for add-on vitamin D were independent of patient’s vitamin D status; therefore, a minimum of a 3 month trial of supplemental vitamin D might be a consideration for management, even in patients with normal serum vitamin D levels. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Poole: Future research should consider extending the observation time past 3 months, as benefits with vitamin D supplementation were not at 6 weeks, but at 3 months. It is not known whether further improvement would occur beyond 3 months. Next, our study was a single center study, and a multi-center study could be considered. Next, our study population was representative of persons in our Mid-West region, and we would recommend studying the effects of supplemental vitamin D in other diverse and under-represented, minority populations. • Citation: • Beneficial role for supplemental vitamin D3 treatment in chronic urticaria: a randomized study • Annals of Allergy, Asthma & Immunology • Available online 5 February 2014 Andy Rorie, Whitney S. Goldner, Elizabeth Lyden, Jill A. Poole Read the rest of the interview on MedicalResearch.com
Should Dental Extractions Be Done Prior to Heart Surgery? MedicalResearch.com Interview with: Dr. Kendra J. Grim Department of Anesthesiology Mayo Clinic, Rochester, MN 55905 • MedicalResearch.com: What are the main findings of the study? • Dr. Grim: “The current guidelines say that if possible, treating the dental problems that patients have before heart surgery is best, to try to prevent both early and late heart infections. But the data is very unclear, because it’s very difficult to study. We found in our study that their risk of serious complications after having teeth removed may be higher than we thought. We were primarily looking at stroke, heart attack, renal failure and death. We found that actually the incidence of having one of those major morbidities was 8 percent. Of that 8 percent, we had six patients, or 3 percent, of the total group who died between their dental surgery and scheduled heart surgery, so these patients never made it to their heart surgery. An additional 3 percent of patients died after heart surgery. “ • MedicalResearch.com: Were any of the findings unexpected? • Dr. Grim: “Yes. The risk of having a serious complication after tooth extraction before heart surgery was higher than we expected, at 8%. Current ACC/AHA guidelines that rate dental extraction a low-risk procedure (<1% risk of major complication or death) may not apply to this patient population.” MedicalResearch.com Dr. Grim: “Our take-home message is that discussion among the specialists – the cardiologist, cardiac surgery, the oral surgeon and the anesthesiologist – would be in the best interest of the patient, to try to ascertain the risk for this particular patient. If we think the risk from taking the teeth out is low, but the benefit is perceived to be high, then we would proceed with the tooth extraction. But if we think the risk of having the teeth extracted before heart surgery is too high, then we would consider not proceeding with the tooth extraction. We really feel that it’s important, because the data is unclear, that rather than following a general rule of thumb, physicians assess each patient’s individual risk. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Grim: “Our hope is that this will spark further conversation that will lead to further research. It’s difficult to study, because the incidence of the infection in the new artificial heart valve is very low. Infection rates have not been studied in patients for bypass grafts, for the ventricular assist devices, total artificial hearts, and there has been minimal research in heart transplantation. So there are a lot of additional avenues open for research in this area to better understand the risk/benefit.” • Citation: • Morbidity and Mortality Associated With Dental Extraction Before Cardiac Operation • Mark M. Smith, David W. Barbara, William J. Mauermann, Christopher F. Viozzi, et al • The Annals of Thoracic Surgery Vol. 97, Issue 3, Pages 838-844 Read the rest of the interview on MedicalResearch.com
Stroke: Speedier Thrombolysis Therapy Prolongs Disability-Free Life MedicalResearch.com Interview with: Atte Meretoja, MD, PhD, MSc (Stroke Medicine) Associate Professor and Principal Fellow (Neurology), University of Melbourne The Royal Melbourne Hospital Australia Associate Professor of Neurology, University of Helsinki Helsinki University Central Hospital, Finland • MedicalResearch.com: What are the main findings of the study? • Dr. Meretoja: We used observational prospective data of consecutive stroke patients (n=2258) treated with intravenous thrombolysis in Australian and Finnish centers and a pooled analysis of thrombolysis trials to model the shift in patient outcomes with reducing treatment delays. We found out that each minute the treatment can be delivered faster granted on average 1.8 days of extra healthy life (95% prediction interval 0.9 to 2.7). In practice, this means that each 15 minute decrease in treatment delays provides an average equivalent of one month of additional disability-free life. MedicalResearch.com: Were any of the findings unexpected? • Dr. Meretoja: The magnitude of benefit from small realistically achievable gains in streamlining thrombolysis services has not been quantified before. This study provides a meaningful metric and an impetus to take action. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Meretoja: Even small achievements in streamlining acute stroke services provide very large health benefits for the patient. Co-operation of the ambulance service, ED, and the stroke team is critical, and validated methods for achieving this have been described by us and others. Best practice centers currently achieve <20 minutes median in-hospital delays, while most hospitals take more than an hour, effectively losing months of healthy life with every treated patient. Every hospital should know its door-to-needle times for stroke thrombolysis, take action to reduce these, and monitor the results. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Meretoja: Intravenous thrombolysis remains the only evidence-based acute recanalization therapy in stroke. Translation to practice has been slow, with the therapy most often contraindicated due to delays. This research should promote service streamlining for the benefit of our patients. Future research should concentrate on methods to further reduce delays and increase rate of use. • Citation: • Stroke Thrombolysis Save a Minute, Save a Day • Atte Meretoja,Mahsa Keshtkaran,Jeffrey L. Saver,Turgut Tatlisumak,Mark W. Parsons,Markku Kaste,Stephen M. Davis,Geoffrey A. Donnan,and Leonid Churilov • Stroke. 2014;STROKEAHA.113.002910published online before print March 13 2014, doi:10.1161/STROKEAHA.113.002910 Read the rest of the interview on MedicalResearch.com
Sports-Related Concussion Diagnosis Using Blood Biomarker Tau MedicalResearch.com Interview with: Pashtun Shahim, MD Clinical Neurochemistry Laboratory Institute of Neuroscience and Physiology Department of Neurochemistry Sahlgrenska University Hospital, Mölndal Sweden • MedicalResearch.com: What are the main findings of the study? • Dr. Shahim: Sports-related concussion in professional ice hockey players is associated with acute axonal and astroglial injury. Plasma total tau, which is a highly central nervous system-specific protein, is a promising biomarker to be used both in the diagnosis of concussion and in the decision-making when an athlete can be declared fit to return to play. MedicalResearch.com: Were any of the findings unexpected? • Dr. Shahim: The levels of total tau correlated with the duration of post-concussive, and the levels even at 144 h after concussion remained significantly elevated in players with persistent post- concussive symptoms > 6 days compared with the levels after a friendly game. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Shahim: Blood biomarkers, specifically total tau is a promising biomarker to be used in the diagnosis and prognosis of athletes with sports-related concussion, as well as patients seeking emergency clinics due to concussion or mild traumatic brain injury. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Shahim: These results are from an on going multi center study on professional ice hockey players from the Swedish Hockey League. These findings need to be replicated in a larger sample size. The promising results should also be evaluated in relation to general concussion in emergency care units. • Citation: • Blood Biomarkers for Brain Injury in Concussed Professional Ice Hockey Player • Shahim P, Tegner Y, Wilson DH, et al. Blood Biomarkers for Brain Injury in Concussed Professional Ice Hockey Players. JAMA Neurol. 2014;():. doi:10.1001/jamaneurol.2014.367. Read the rest of the interview on MedicalResearch.com
Ocular Injuries from Laser Pointers MedicalResearch.com Interview with: Glenn Yiu, MD, PhD Duke Ophthalmology Duke University Medical Center • MedicalResearch.com: What are the main findings of the study? • Dr. Yiu: This paper reported a child who suffered injury to both eyes from a powerful blue laser pointer purchased via the internet from overseas. Our report reviews the scientific basis for laser injuries in eyes and the factors that may affect outcomes, such as power, wavelength, duration, and distance of exposure. Newer green and blue lasers, especially high- powered ones, may be more prone to inducing eye injuries. We summarized the clinical features of ocular laser injuries, methods of prevention, and discussed how consumer availability of high powered lasers may require careful federal regulations. • MedicalResearch.com: Were any of the findings unexpected? • Dr. Yiu: In this case, the laser caused retinal hemorrhages in both eyes resulting in severe loss of vision. This is uncommon since laser injuries over short distances are typically unilateral. The circumstances are unclear surrounding the young victim playing with an adult who directed the laser at him in jest. Fortunately, the hemorrhages resolved after several months and did not appear to result in permanent damage. This is not always the case, as some patients may suffer permanent scarring or recurrent bleeding from abnormal growth of blood vessels (known as choroidal neovascularization) as a result of the laser damage. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Yiu: Unlike trained personnel in occupational settings, the average consumer may not be familiar with laser safety practices. Ocular laser injuries among consumers may be underreported, and prompt referral to an ophthalmologist is necessary for diagnosis, possible treatment, and documentation for medicolegal purposes. Laser goggles are important for prevention of laser injuries, and care should be taken to ensure that the laser goggles are specific for the wavelength of the laser being used. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Yiu: Increased available of lasers in the consumer market requires careful regulation. High powered devices, particularly those with shorter-wavelengths, should be clearly labeled and safety instructions provided to ensure use of appropriate laser safety goggles or other barriers. Improved consumer awareness will be important for preventing future incidents from occurring. • Citation: Ocular Safety of Recreational Lasers • JAMA Ophthalmol. 2014 Jan 9. doi: 10.1001/jamaophthalmol.2013.5647. [Epub ahead of print] • Yiu G, Itty S, Toth CA. Read the rest of the interview on MedicalResearch.com
CABG Surgery in Patients with Acute Coronary Syndromes and Chronic Kidney Disease MedicalResearch.com Interview with: Martin Holzmann, MD, PhD Department of Emergency Medicine, Karolinska University Hospital Stockholm Sweden. • MedicalResearch.com: What are the main findings of the study? • Dr. Holzmann: The main finding is that patients with renal dysfunction are at increased risk of cardiovascular events after undergoing CABG for acute coronary syndromes. MedicalResearch.com: Were any of the findings unexpected? • Dr. Holzmann: We would have expected that the association would have been stronger than it was. We found an association only in patients with severe renal dysfunction. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Holzmann: Cardiologists should not hesitate to send their patients with renal dysfunction to undergo CABG in case it is needed. The prognosis after CABG is excellent even in patients with rather advanced renal dysfunction. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Holzmann: More research is needed to elucidate if there is a causal association between renal dysfunction and cardiovascular outcomes. Maybe renal dysfunction is merely a marker of increased risk or a composite of other cardiovascular risk factors. • Citation: • Long‐term Cardiovascular Outcomes in Patients With Chronic Kidney Disease Undergoing Coronary Artery Bypass Graft Surgery for Acute Coronary Syndromes • Citation: • Long‐term Cardiovascular Outcomes in Patients With Chronic Kidney Disease Undergoing Coronary Artery Bypass Graft Surgery for Acute Coronary Syndromes • Martin Holzmann, Tomas Jernberg, Karolina Szummer, and Ulrik Sartipy • J Am Heart Assoc. 2014;3:e000707, originally published March 4, 2014, doi:10.1161/JAHA.113.000707 Read the rest of the interview on MedicalResearch.com
Surgical Safety Checklists Did Not Substantially Improve Surgical Outcomes MedicalResearch.com Interview with: David R. Urbach, M.D From the Institute for Clinical Evaluative Sciences Department of Surgery Institute of Health Policy, Management and EvaluationUniversity of Toronto, the University Health Network Toronto, ON M5G 2C4, Canada • MedicalResearch.com: What are the main findings of the study? • Dr. Urbach: After surgical safety checklists were adopted by hospitals in Ontario, surgical outcomes—death after surgery, complications, length of stay, readmissions—did not improve substantially. MedicalResearch.com: Were any of the findings unexpected? • Dr. Urbach: These findings were unexpected because previous research suggested that there were large benefits from introducing surgical safety checklists. For example, the risk of death after surgery was reduced between 30% and 50% among early studies. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Urbach: Improving surgical safety requires more than just introducing safety checklists. Meaningful improvements in safety will probably require comprehensive, team-based interventions that result in a lasting change in culture. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Urbach: We need to continue to explore how safety and quality can be improved in surgery. Checklists are an important part of this, but not sufficient by themselves to cause major improvements. • Citation: • Introduction of Surgical Safety Checklists in Ontario, Canada • David R. Urbach, M.D., Anand Govindarajan, M.D., Refik Saskin, M.Sc., Andrew S. Wilton, M.Sc., and Nancy N. Baxter, M.D., Ph.D. • N Engl J Med 2014; 370:1029-1038 • March 13, 2014DOI: 10.1056/NEJMsa1308261 Read the rest of the interview on MedicalResearch.com
Bipolar Disorder: Genome-Wide Association Study MedicalResearch.com Interview with: Prof. Dr. Sven Cichon, PhD Director, Division of Medical Genetics University Hospital Basel Human Genomics Research Group Department of Biomedicine University of Basel Basel, Switzerland • MedicalResearch.com Interview with: Prof. Dr. Sven Cichon, PhD Director, Division of Medical Genetics University Hospital Basel Human Genomics Research Group Department of Biomedicine University of Basel Basel, Switzerland • MedicalResearch.com: What were the main findings of the study? • Answer: We have identified two new gene regions that represent pieces of the jigsaw puzzle of genetic and non-genetic factors that lead to the development of bipolar disorder. One is the gene ADCY2 (Adenylate Cyclase 2) which is involved in signal transmission within nerve cells. The other region comprises two genes, both presumably playing a role in neurodevelopmental processes (MIR2113 and POU3F2). Importantly, these results come out of the largest of these kinds of studies so far, involving altogether more than 24,000 people. MedicalResearch.com: Were the findings unexpected? • Answer: The exact nature of the identified genes and their involvement in bipolar disorder is new to us. We have indication from other susceptibility genes found in previous studies of bipolar disorder that both nerve cell signalling as well as neurodevelopmental processes may play a role in this common neuropsychiatric disorder. However, there are literally thousands of genes that are somehow related to these biological functions in the human brain. Our study now support the importance of these biological functions in disease development and specify more of the involved genes. • MedicalResearch.com: What should clinicians and patients take away from your report? • Answer: The most important message is that these kinds of studies help to understand the biological foundations of bipolar disorder. It is a long way because the disease is so complex, but step by step we are getting there. Biological knowledge of the disease will eventually be the starting point for new therapies. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Answer: The recent successes in identifying genetic factors involved in bipolar disorder and other complex diseases are the result of large international collaborations. In the present study, we have joined data generated by the MooDS consortium –involving researchers from Europe, Australia, and Canada- and the largest international consortium in the field of psychiatric genetic research, the Psychiatric Genomics Consortium (PGC). This enabled us to assemble the most powerful data set to date for such a systematic genetic study. Large numbers are necessary to clearly see the minor genetic differences of individual genes between patients and controls against the ‘background noise’ of genetic differences. • It is therefore of utmost importance to continue and extend large, international collaborations involving numerous psychiatrists, geneticists and statisticians world-wide. • Citation: • Genome-wide association study reveals two new risk loci for bipolar disorder • Nature Communications 5, Article number:3339 doi:10.1038/ncomms4339 Read the rest of the interview on MedicalResearch.com
Long-Term Risk of Stroke Raised by PreHypertension MedicalResearch.com Interview with: Dingli Xu, MD From Department of Cardiology Nanfang Hospital, Southern Medical University, Guangzhou, China • MedicalResearch.com: What are the main findings of the study? • Answer：Our study showed that after controlling for multiple cardiovascular risk factors, the blood pressure range at 120-139/80-89 mm Hg (defined as ‘prehypertension’ in JNC 7), is significant associated with long-term risk of stroke. The results were consistent across stroke type, stroke endpoint, age, study characteristics, follow-up duration, and ethnicity. More importantly, even low- range prehypertension (BP 120-129/80-84mmHg) increased the risk of stroke compared with optimal BP (<120/80 mm Hg), and the risk was higher in individuals with high-range prehypertension (BP 130-139/85-85mmHg). In particular, we found that compared with individuals with optimal blood pressure individuals with low-range prehypertension were 44% more likely to develop stroke, and this risk was even greater (95%) in individuals with high-range prehypertension. • MedicalResearch.com: Were any of the findings unexpected? • Answer: Yes, we believed that two findings are very interesting. First, prehypertension, which seemed “normal” in the past, is significant associated with risk of stroke, even after adjusted multiple cardiovascular risk factors. This means that the mild elevation of blood pressure could directly increases the risk of stroke. • Second, even low range prehypertension, which is defined as ‘normal blood pressure’ in some hypertension guideline, could also increase the risk of stroke significantly. This result is different with prior studies and meta analysis. Therefore, our findings reaffirms the importance of the definition of “prehypertension” rather than being “normal”. Read the rest of the interview on MedicalResearch.com
Long-Term Risk of Stroke Raised by PreHypertension MedicalResearch.com Interview with: Dingli Xu, MD From Department of Cardiology Nanfang Hospital, Southern Medical University, Guangzhou, China • MedicalResearch.com: What should clinicians and patients take away from your report? • Answer: These findings have important clinical and public health implications. First, clinicians and patients should be aware of that blood pressure range at 120-139/80-89mmHg is not “normal”. These individuals are at a high risk to progress to sustained hypertension, as well as CVD, especially stroke, so periodic screening is important. Second, considering the robust evidence of an association between prehypertension and the risk of stroke shown in our study, it is preferable to consider earlier interventions for prehypertension among the general population. Currently, lifestyle modification is the mainstay of treatment for prehypertension in the general population (e.g. quit smoking, increased physical activity, maintain proper body weight.). This should be recommended to every individuals with prehypertension. • However, because of the significant difference in the risk of stroke for BP between 120–129/80–84 mm Hg and 130–139/85– 89 mm Hg, we suggest that, for clinicians, this category should be subdivided into low- and high-range prehypertension. Further studies are needed to reveal better predictors of high-risk subpopulations with prehypertension (especially in high- range prehypertension) to select subpopulations for future controlled trials of pharmacological treatment. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Answer: In our study, we found that prehypertension, even in the low range, elevates the risk of stroke after adjusting for multiple cardiovascular risk factors. However, whether treatment of prehypertension can reduces the risk of target organ damage is still with controversies. Based on the lack of prospective, randomized trials examining the effects of anti- hypertensive therapy on reducing target organ damage specifically in prehypertensives, professional societies do not recommend drug treatment in prehypertension, even in high-range prehypertension. • So we think that there is a great gap to be covered between epidemiological studies and randomized controlled studies in prehypertension. Prehypertensive individuals are at a high risk to progress to sustained hypertension, as well as CVD, especially stroke. So for therapeutic implications, we emphasize that lifestyle intervention, but not medical intervention is the mainstay of treatment for prehypertension. However, high-risk subpopulations with prehypertension are needed to be selected for future controlled trials of pharmacological treatment. • Citation: • Prehypertension and the risk of stroke A meta-analysis • Yuli Huang, MD, Xiaoyan Cai, MD, Yingying Li, MD, Liang Su, MD, Weiyi Mai, MD, PhD, Sheng Wang, MD, Yunzhao Hu, MD, Yanxian Wu, MD and Dingli Xu, MD • Published online before print March 12, 2014, doi: 10.1212/WNL.0000000000000268 Neurology Read the rest of the interview on MedicalResearch.com
Low Birth Weight Babies at Higher Risk of Infertility Later in Life MedicalResearch.com Interview with: Dr Josefin Vikström Division of Obstetrics and Gynecology Department of Clinical and Experimental Medicine Faculty of Health Sciences Linköping University, Linköping, Sweden • MedicalResearch.com: What are the main findings of the study? • Dr. Vikström: Our study showed that women with a female infertility factor were more than two times more likely to have been born with a low birth weight (less than 2500g) or small for gestational age compared to women where the cause of infertility was unknown and/or male. MedicalResearch.com: Were any of the findings unexpected? • Dr. Vikström: We hypothesized that being born with a low birth weight (<2500g) would increase the risk of infertility since the risk of other diseases such as cardiovascular disease and the metabolic syndrome is increased in these individuals. However, since this study is the first of its kind it was difficult to predict the results. • MedicalResearch.com: What should clinicians and patients take away from your report? • Dr. Vikström: Women born with a low birth weight might be at increased risk of infertility later on in life but more studies are needed to verify these results. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Vikström: More studies are needed to determine that there is an association between low birth weight and infertility in women and in that case why these women are at increased risk of infertility. • Citation: • Birth characteristics in a clinical sample of women seeking infertility treatment: a case–control study • Josefin Vikström, Mats Hammar, Ann Josefsson, Marie Bladh, Gunilla Sydsjö • BMJ Open 2014;4:3 e004197 doi:10.1136/bmjopen-2013-004197 Read the rest of the interview on MedicalResearch.com
Sleep Decreased In Children Who Watch Excessive Television MedicalResearch.com Interview with: Marcella Marinelli, MSc, PhD Center for Research in Environmental Epidemiology Hospital del Mar Research Institute Spanish Consortium for Research on Epidemiology and Public Health Barcelona, Spain • MedicalResearch.com: What are the main findings of your study? • Answer: We found that each hour a day of television viewing decreased sleep by 13 % in the Joint group. I also examined the changes in terms of television behavior: Children who increased television exposure at 4 years in Sabadell and Valencia reduced sleep duration of a 20%. While children who reduced the amount of time spent in front of the television had some recovery of sleep duration. • Also children who watched more or exactly 1.5 hours of television at 2 years in Sabadell and Valencia reduced their sleep duration of a 30% compared to children who watched television for less than 1.5 hours per day. Moreover children that change their behavior and at 4 years reduced the amount of time spent in front of television (in this case children who pass from the >=1.5 hours per day group to the <1.5 hours per day group) had a recovery effect, increasing their sleep duration, although the coefficient is not statistically significant. Also children who pass from watching television for less than 1.5 hours per day and increase the amount of time spent in front of the television (more or equal to 1.5 hours per day) at 4 years decrease their sleep duration of 30%. • MedicalResearch.com: Were any of the findings unexpected? • Answer: Yes I could not believe that some of the children in my study watch television for 6-8 hours per day! • MedicalResearch.com: What should clinicians and patients take away from your report? • Answer: Clinicians should recommend parents to limit the use of television and other devices. Parents should avoid continuous exposure of children in front of the television and mobile phones and stimulate them with other activities such as music, sport or family life. Also play together will be beneficial. Television should be limited to no more than an hour and also the content of TV program should be monitored. There are some studies that evaluated the relationship between TV viewing and aggressive behavior. So be careful! • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Answer: Future research should consider the type of programs that children watch and other television habits in a longitudinal design. We could not distinguish between active and passive television exposure (TV is just switched on for example) so should be also interesting to evaluate if there is any differences on sleep duration. It will also important to evaluate more assessments for television and sleep during the all week. • I would like to add that I am very active in divulgating epidemiological research based on children in my life and for this reason I have created a blog for parents in Italy www.bambinofelice.it. • Citation: • Marinelli M, Sunyer J, Alvarez-Pedrerol M, et al. Hours of Television Viewing and Sleep Duration in Children: A Multicenter Birth Cohort Study. JAMA Pediatr. 2014;():. doi:10.1001/jamapediatrics.2013.3861. Read the rest of the interview on MedicalResearch.com
Randomized Controlled Trials: 25% Discontinued, Mostly in Patient Studies MedicalResearch.com Interview with: Matthias Briel, MD, MSc Basel Institute for Clinical Epidemiology and Biostatistics, University Hospital of Basel, Basel, Switzerland Department of Clinical Epidemiology and Biostatistics, McMaster University, Hamilton, Ontario, Canada • MedicalResearch.com: What are the main findings of the study? • Dr. Briel: Using a retrospective cohort of 1017 randomized controlled trials (RCTs) based on archived protocols approved by six research ethics committees in Switzerland, Germany, and Canada between 2000 and 2003, we found that 25% of initiated RCTs were discontinued. While discontinuation was common with RCTs involving patients (28%), it was rare in RCTs with healthy volunteers (3%). The most commonly reported reason for RCT discontinuation was poor recruitment (10% of included RCTs). We found that trials with investigator sponsor (versus industry) and those with smaller planned sample sizes were at higher risk of discontinuation due to poor recruitment. Of discontinued RCTs, up to 60% remained unpublished. Trial investigators rarely informed research ethics committees about trial discontinuation and publication. • MedicalResearch.com: Were any of the findings unexpected? • Dr. Briel: We did not expect such a poor reporting to ethics committees. Overall, only 96 of 253 discontinuations (38%) were reported to research ethics committees. For randomized controlled trials discontinued due to poor recruitment discontinuation was reported in 24 of 101 RCTs (24%), for RCTs discontinued due to futility it was 16 of 37 RCTs (43%), and for RCTs discontinued due to harm it was 13 of 24 RCTs (54%). • MedicalResearch.com: What should clinical researchers and patients take away from your report? • Dr. Briel: Our findings indicate that ethical obligations of RCTs are frequently not met. Failure to report premature discontinuation to ethics committees limits the ethics committees’ ability to carry out their mandate of ensuring ethical trial conduct and to monitor problematic randomized controlled trials. Not sharing with the scientific community the challenges resulting in RCT discontinuation removes any opportunity for learning within the trialist community, including identifying risks and instituting preventative action. Non- publication of inconclusive results leads to loss of valid evidence that could contribute to systematic reviews and meta-analyses. Our findings also highlight the necessity of current efforts to enhance the transparency, quality, and accessibility of trial protocols and results such as the ‘Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT)’ and ‘AllTrials’ (www.alltrials.net) initiatives. Patient recruitment to trials should be closely monitored and contingency plans should be in place if it is lower than expected. • MedicalResearch.com: What recommendations do you have for future research as a result of this study? • Dr. Briel: For investigator-initiated RCTs, stakeholders including trial investigators, funding agencies, and ethics committees need to develop strategies to prevent trial discontinuation. Based on our data retrospective or prospective screening of patients appears to hold little promise in estimating recruitment rates, but conducting a pilot study including patients’ consent to check that recruitment strategies are adequate might be effective. Further research is necessary to determine the optimal length of pilot trials and to develop reliable prediction models for recruitment performance. • Citation: • Prevalence, Characteristics, and Publication of Discontinued Randomized Trials • Kasenda B, von Elm E, You J, et al. Prevalence, Characteristics, and Publication of Discontinued Randomized Trials. JAMA. 2014;311(10):1045-1052. doi:10.1001/jama.2014.1361. Read the rest of the interview on MedicalResearch.com
E-Cigarettes Use By Adolescents May Lead to Heavier Smoking MedicalResearch.com Interview with: Lauren Dutra, ScD Postdoctoral Scholar, UCSF School of Medicine Cardiovascular Research Institute San Francisco, CA 94143 • MedicalResearch.com: What are the main findings of the study? • Answer: Middle and
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