Partial Meniscectomy Doesn’t Reduce Mechanical Knee Symptoms Any Better Than Sham Procedure

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MedicalResearch.com Interview with:

Teppo L N Järvinen MD PhD Sports Medicine, Orthopedic Surgery, Clinical Trials University of Helsinki, Helsinki

Dr. Teppo Järvinen

Teppo L N Järvinen MD PhD
Sports Medicine, Orthopedic Surgery, Clinical Trials
University of Helsinki, Helsinki

MedicalResearch: What is the background for this study? What are the main findings?

Dr. Järvinen: When the primary analysis of the FIDELITY trial was published in the New England Journal of Medicine (http://www.nejm.org/doi/full/10.1056/NEJMoa1305189), showing that arthroscopic partial meniscectomy (APM) is no better than sham/placebo surgery in relieving knee pain and improving knee function in patients with a degenerative meniscus tear and no knee OA, the study was met with unprecedented criticism, even hostility. The advocates of APM (which was at the time and probably still is the most common orthopedic procedure in the US and most other “western” countries) argued – despite the fact that our study only confirmed what several other high-quality RCTs had suggested – that  arthroscopic partial meniscectomy is a highly beneficial procedure in the “right” patients. Among the subgroups of patients allegedly having a favourable response to APM, those experiencing “mechanical symptoms” — sensations of knee catching or locking — represented the most obvious group who would benefit from  arthroscopic partial meniscectomy surgery. This assertion is plausible because knee catching or locking is believed to result from a mechanical blocking mechanism in the knee – a piece of the joint structure lodging between the articular surfaces. Because degenerative meniscal tears are very common pathologic alterations found by arthroscopy in the knee joints of patients with degenerative knee disease, trimming the torn meniscus should, in theory at least, improve the apparent mechanical derangement.

Against this background, it is somewhat unusual that no study has yet specifically tested whether  arthroscopic partial meniscectomy is effective in alleviating these symptoms. Mechanical symptoms are usually thought to be a solid indication for arthroscopic knee surgery. This is what we set out to examine in our secondary analysis of our sham-surgery controlled FIDELITY trial.

Our key finding: arthroscopic partial meniscectomy (partial resection of a torn meniscus) does not reduce or alleviate mechanical symptoms any better than a sham surgical procedure.

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Nanobody is Potentially First Targeted Therapy for TTP

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MedicalResearch.com Interview with:
Dr. Filip Callewaert PhD
Senior Clinical Scientist
Clinical Development, Ablynx
Zwijnaarde, Belgium

Medical Research: What is the background for this study? What are the main findings?

Dr. Callewaert: Acquired thrombotic thrombocytopenic purpura (TTP) is a rare and life-threatening coagulation disorder, in which accumulation of ultra-large von Willebrand factor (ULvWF) multimers is implicated, leading to an increased risk of thrombus formation in small blood vessels due to excessive platelet aggregation. There are no approved pharmacological therapies for acquired TTP. Despite treatment with the current standard of care (plasma exchange and immunosuppressive therapy), mortality remains at 10-20% and there is significant neurological, cardiac, and renal morbidity.

Caplacizumab is a bivalent Nanobody that binds to the A1 domain of vWF thereby preventing vWF-mediated platelet aggregation. The clinical effects of caplacizumab were demonstrated in the phase II randomised, placebo-controlled TITAN study in 75 patients with acquired TTP. Compared to placebo, there was a nearly 40% reduction in median time to platelet count normalisation in the caplacizumab group (p = 0.005). Treatment with caplacizumab reduced the use of daily plasma exchange and prevented further consumption of platelets in microthrombi and small blood vessel occlusion. In addition, there were fewer recurrences of TTP requiring re-initiation of daily plasma exchange during treatment with caplacizumab (N=3) vs. placebo (N=11). The safety profile of caplacizumab was favorable, with a slightly higher tendency of mostly mild bleeding events.  Continue reading

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Euthanasia and/or Physician Assisted Suicide in Psychiatric Disorders Legal in Belgium and The Netherlands

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MedicalResearch.com Interview with:

Scott Y. H. Kim, MD, PhD Department of Bioethics, National Institutes of Health Bethesda, MD 20892

Dr. Scott Kim

Scott Y. H. Kim, MD, PhD
Department of Bioethics, National Institutes of Health
Bethesda, MD 20892

Medical Research: What is the background for this study?

Dr. Kim: Euthanasia and/or physician assisted suicide (EAS) of persons suffering from psychiatric disorders is increasingly practiced in some jurisdictions such as Belgium and the Netherlands but very little is known about the practice.  There is an active debate over whether to legalize such a practice in Canada, after a Supreme Court ruling last year that struck down laws banning physician assisted death. 

Medical Research: What are the main findings?

Dr. Kim: The main findings are that:

  1. Most patients who receive psychiatric euthanasia and/or physician assisted suicide are women, of diverse ages, with a variety of chronic psychiatric conditions accompanied by personality disorders, significant physical problems, and social isolation/loneliness, often in the context of refusals of treatment.  A minority who are initially refused EAS ultimately receive euthanasia and/or physician assisted suicide through a mobile euthanasia clinic.
  2. Given that the patients have chronic, complicated histories requiring considerable physician judgment, extensive consultations are common. But independent psychiatric input does not always occur; disagreement among physicians occurred in one in four cases; and the euthanasia review committees generally defer to the judgments of the physicians performing euthanasia and/or physician assisted suicide.

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Accidents, Guns and Overdoses Account For Increase in Death Rate in US Adults

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MedicalResearch.com Interview with:

Dr. Andrew Fenelon PhD NIH Postdoctoral Fellow Brown University

Dr. Andrew Fenelon

Dr. Andrew Fenelon PhD
NIH Postdoctoral Fellow
Brown University

Medical Research: What is the background for this study? What are the main findings?

Dr. Fenelon: The life expectancy of the US population is about 2 years less than that of other high-income nations, which is an important problem in public health. Although much previous work looks at differences in death rates among older adults, some recent work has shown that deaths at younger ages (below age 50) account for a significant fraction of the life expectancy gap. Our study examines the contribution of major injuries, Motor Vehicle Crashes, Firearm-related deaths, and drug poisonings, which often occur at younger ages and account for many years of lost life.

Our findings indicate that US men and women experience significantly higher death rates from these three causes of injury death than each of the 12 comparison high-income countries. Overall, these three causes of death explained 48% of the 2.2 year life expectancy gap between the United States and other high-income countries among men, with firearm injuries alone explaining 21%. Among women, these causes explained 19%.

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Radiation Converts Some Resistant Head and Neck Cancer Cells Into Aggressive Stem Cells

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MedicalResearch.com Interview with:

Erina Vlashi, PhD Assistant Professor Department of Radiation Oncology David Geffen School of Medicine at UCLA Los Angeles, CA 90095-1714

Dr. Erina Vlashi

Erina Vlashi, PhD
Assistant Professor
Department of Radiation Oncology
David Geffen School of Medicine at UCLA
Los Angeles, CA 90095-1714

Medical Research: What is the background for this study? What are the main findings?

Dr. Vlashi: It has been known for quite some time that head and neck squamous cell carcinomas (HNSCC) that test positive for human papilloma virus (HPV) respond to radiation therapy more favorably than HPV-negative HNSCCs. Our team reviewed a cohort of 162 patients with a head and neck squamous carcinoma diagnosis over a two-year period, and confirmed that the outcomes were correlated with the patient’s HPV status. The work that followed was prompted by a discovery we had made earlier in breast cancer suggesting that breast cancer cells that manage to survive radiation therapy have the capacity to convert into more de-differentiated, therapy-resistant cells with characteristics of cancer stem cells, and that the degree of this conversion depended on the type of breast cancer: the more aggressive types of breast cancer being more prone to the therapy-induced phenotype conversion. So, we hypothesized that this therapy-induced conversion phenomenon may especially be at play in  head and neck squamous cell carcinomas given the clinical observation that HPV-positive HNSCCs respond to radiation therapy much more favorably than HPV-negative HNSCCs, despite optimum treatment modalities. And indeed, that is what we found: tumor cells derived from a panel of  head and neck squamous cell carcinomas cell lines that do not respond well to radiation therapy have an enhanced ability to convert the cells that survive radiation into more aggressive cells, cancer stem-like cells that will resist the next round of radiation therapy.  Continue reading

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Gastric Bypass Surgery Reduces Mortality Even In Older Patients

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MedicalResearch.com Interview with:

Lance Davidson, PhD Assistant Professor Department of Exercise Sciences Brigham Young University Provo, UT 84602

Dr. Lance Davidson

Lance Davidson, PhD
Assistant Professor
Department of Exercise Sciences
Brigham Young University
Provo, UT  84602 

Medical Research: What is the background for this study? What are the main findings?

Dr. Davidson: A growing body of literature indicates that bariatric surgery imparts a mortality benefit in severely obese individuals.  Whether age at surgery affects this relationship is not well established.  One might suppose that a person who has been severely obese for several decades may already have sustained enough metabolic damage that weight loss surgery would have less influence on subsequent mortality.  We conducted an age-specific analysis of a previously-published mortality cohort in gastric bypass patients and severely obese controls, following them for up to 18 years (mean 7.2 years), and examined mortality rates in four age categories: under 35, 35-44, 45-54, and 55-74.

The primary finding of this retrospective cohort study was that gastric bypass surgery attenuated the age-related increase in mortality, demonstrating a widening gap in mortality risk when compared to age-matched severely obese controls as age-at-surgery increased, with a 66% reduction in mortality in the oldest group.  Another interesting result, highlighted in our previous publication on this cohort (Adams et al. NEJM 2007), was a higher mortality rate from external causes (accidents, poisonings, suicides, homicides) in surgery patients.  We explored this phenomenon further by age at surgery and found that externally-caused deaths were only increased in women (not men) who had surgery before age 35.

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Alcohol Impaired Driving Crimes Rise Right After Legal Drinking Age Reached

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MedicalResearch.com Interview with:

Dr. Russ Callaghan, PhD Associate Professor Northern Medical Program University of Northern British Columbia Prince George, British Columbia

Dr. Russ Callaghan

Dr. Russ Callaghan, PhD
Associate Professor
Northern Medical Program
University of Northern British Columbia
Prince George, British Columbia 

Medical Research: What is the background for this study?

Dr. Callaghan: In Canada, the minimum legal drinking age (MLDA) is 18 years in Alberta, Manitoba and Québec, and 19 in the rest of the country. Given that public-health organizations not only have recommended increasing the MLDA to 19 years, but also have identified 21 years as ideal, the current study tested whether drivers slightly older than the MLDA had significant and abrupt increases in alcohol-impaired driving (AID) crimes, compared with their counterparts just younger than the MLDA. Data on the effectiveness of Canadian drinking-age laws is lacking, and the current study provides important information for the current national and international MLDA debates.

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Link Between Zika Virus, Microcephaly, Stillbirths and Miscarriages

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MedicalResearch.com Interview with:
Nancy Dirubbo, DNP, FNP, FAANP
, Certificate in Travel Health, American Association of Nurse Practitioners (AANP) Fellow
Cindy Cooke, DNP, FNP-C, FAANP, American Association of Nurse Practitioners (AANP) President of the Board

Medical Research: Can you provide some background on what is the Zika virus?

Response: Zika virus was first found in monkeys in the Zika Forest of Uganda in 1947 during a research project on mosquito borne viral diseases. From Africa, it spread to India, Indonesia and South East Asia over the next 20-30 years. Not much attention was paid to this illness, as it is often asymptomatic (perhaps as much as 80% of all cases). It causes few symptoms in adults (mild rash, conjunctivitis and headache) and so is often underdiagnosed or misdiagnosed as other self-limiting, viral diseases. Then fast forward to 2015, when a sudden increase in infants born in Brazil with microcephaly occurred and a connection was made with a sharp increase in Zika viral infections, even though the direct mechanism for causing this birth defect is not known. In 2014, there were less than 150 cases of microcephaly in Brazil, and by October 2015, there were 4,700 cases reported.

Medical Research: What is the concern regarding pregnant women and their babies?

Response: The concern for pregnant women is that there appears to be a link between Zika virus and microcephaly, still birth and miscarriages. Children who do survive have severe intellectual disabilities. The virus is most often transmitted by mosquitos, but may also be sexually transmitted. According to the CDC, “Sexual transmission of Zika virus is possible, and is of particular concern during pregnancy. Current information about possible sexual transmission of Zika is based on reports of three cases.” The CDC also recommends, “Men who reside in or have traveled to an area of active Zika virus transmission who have a pregnant partner should abstain from sexual activity or consistently and correctly use condoms during sex (i.e., vaginal intercourse, anal intercourse or fellatio) for the duration of the pregnancy.” It has yet to be determined if Zika virus can be transmitted in other ways, including blood transfusions.

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Flu Infection Raises Risk of New Onset Atrial fibrillation

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MedicalResearch.com Interview with:
Tze-Fan Chao MD PhD
Division of Cardiology, Department of Medicine
Taipei Veterans General Hospital
Institute of Clinical Medicine, and Cardiovascular Research Center
National Yang-Ming University, Taipei, Taiwan
Su-Jung Chen MD
Division of Infectious Diseases, Department of Medicine, Taipei Veterans General Hospital,
Institute of Public Health and School of Medicine, National Yang-Ming University
Taipei, Taiwan

MedicalResearch: What is the background for this study? What are the main findings?

Response: Atrial fibrillation (AF) is the most common cardiac arrhythmia in clinical practice, accounting for frequent hospitalizations, hemodynamic abnormalities, and thromboembolic events. Although the detailed mechanism of the occurrence of Atrial fibrillation remains unclear, systemic inflammation and sympathetic nervous system have been demonstrated to play an important role in the pathogenesis of AF. Flu (influenza infection) is a common disease which could happen to everyone in the daily life. It could cause significant morbidity and mortality, and is a serious human health concern worldwide. Previous studies have shown that influenza infection not only results in the productions of pro-inflammatory cytokines, but also activates the sympathetic nervous system, which are all related to the occurrence of  Atrial fibrillation. Therefore, we hypothesized that influenza infection could be a risk factor of new-onset AF. We also tested the hypothesis that influenza vaccination, a useful way to reduce the risk of influenza infection, could decrease the risk of AF.

In this large scale nationwide case-control study, a total of 11,374 patients with newly diagnosed  Atrial fibrillation were identified from the Taiwan National Health Insurance Research Database. On the same date of enrollment, 4 control patients (without AF) with matched age and sex were selected to be the control group for each study patient. The relationship between AF and influenza infection/vaccination 1 year before the enrollment was analyzed. The results showed that influenza infection was associated with an 18% increased risk of AF, and the risk could be easily reduced through influenza vaccination.

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Only Small Increase in CT Screening for Lung Cancer Despite New Guidelines

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MedicalResearch.com Interview with:

Phillip M. Boiselle, MD Professor of Radiology and Associate Dean for Academic and Clinical Affairs Harvard Medical School Beth Israel Deaconess Medical Center Boston, Massachusetts

Dr. Phillip Boiselle

Phillip M. Boiselle, MD
Professor of Radiology and Associate Dean for Academic and Clinical Affairs
Harvard Medical School
Beth Israel Deaconess Medical Center
Boston, Massachusetts

Medical Research: What is the background for this study?

Dr. Boiselle: We surveyed leading academic medical centers in 2013 and found considerable variability in their practice patterns as well as a relatively small number of patients being screened for lung cancer at these sites. Considering landmark developments since that time, including favorable policy and payment decisions by USPSTF  and CMS  and development of radiology-specific nodule guidelines by the American College of Radiology, we were curious to see whether there would be greater conformity of practice patterns and increased patient volumes in response to these developments.

Medical Research: What are the main findings?

Dr. Boiselle: First, our finding of greater conformity of lung cancer screening practices at present compared to 2013 confirmed our hypothesis that the development of radiology-specific guidelines by ACR would contribute to greater uniformity.

Second, we were surprised by the very modest level of increase in patient volumes for CT screening over time despite the favorable USPSTF and CMS decisions. We emphasize, however, that the timing of our survey occurred too early to determine the full impact of CMS coverage on patient volumes

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Some Bacteria In Stored Food Raise Markers of Inflammation

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MedicalResearch.com Interview with:

Dr. Clett Erridge PhD Department of Cardiovascular Sciences University of Leicester Clinical Science Wing Glenfield General Hospital Leicester

Dr. Clett Erridge

Dr. Clett Erridge PhD
Department of Cardiovascular Sciences
University of Leicester
Clinical Science Wing
Glenfield General Hospital
Leicester

Medical Research: What is the background for this study? What are the main findings?

Dr. Erridge: We have spent many years seeking potential stimuli that might be responsible for triggering the chronic inflammatory processes that underpin atherosclerosis. Our earlier work focused mainly on the questions of whether and how various molecules related to lipoprotein particles, oxidised lipids and fatty acids interacted with receptors of the innate immune system, which we believe are central players in the initiation of atherosclerosis. However, we were surprised to discover (as a result of some control experiments that we expected to yield a null result), that extracts of some, but not all, foods trigger inflammatory cytokine production in human monocytes via stimulation of the innate immune receptors Toll-like receptor (TLR)-2 and TLR4. The molecules responsible for triggering these responses (collectively termed PAMPs, ‘pathogen-associated molecular patterns’), were found to arise in foods that have been finely chopped and stored at refrigeration temperature or above for some time, as a result of the growth and activity of common food spoilage bacteria. The foods most commonly affected are minced meats, ready chopped vegetables, some cheeses and chocolates.

The present study found that in 11 healthy volunteers who habitually consumed food products rich in PAMPs, switching to a low PAMP diet for 7 days resulted in an 18% reduction in LDL-cholesterol, 11% reduction in white blood cell count, a 1.5 cm reduction in waist circumference and a 0.6 kg reduction in body weight. Switching back to a high PAMP diet, in which the same volunteers were then fed meals tested and proven to be high in PAMPs, for just 4 days reversed these beneficial effects.

A second study in 13 healthy volunteers then showed that PAMPs can exert effects on white cell markers of inflammation within 24 h of consumption, when volunteers were fed either fresh or processed onion-based meals, which were nutritionally identical other than for content of bacteria and PAMPs.

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Tumor Suppressor Protein p53 Affects Progression of Rare Kidney Disease

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MedicalResearch.com Interview with:

Prof. Hirofumi Kai Kumamoto University Japan

Prof. Hirofumi Kai

Prof. Hirofumi Kai
Kumamoto University
Japan

MedicalResearch: What is the background for this study?

Dr. Kai: Alport Syndrome (AS) is a hereditary progressive kidney disease that affects 1 in 5000-10000 individuals in the US. Depending on the specific subtype and genetic mutation, the onset, symptoms and progression vary among patients. Some have earlier onset and severe phenotypes while others have slow progression towards end-stage renal disease (ESRD). The gene affected in  Alport Syndrome is type 4 collagen, which codes for a protein component of the glomerular basement membrane (GBM). This mutation leads to the dysregulated proliferation (or dysplasia) of the GBM, which has an important role in urine filtration. The pathophysiological process of dysplasia indicates a dysfunction of protein/s that control cellular homeostasis. Because the tumor suppressor p53 is critically involved in modulating cell proliferation, we focused our attention on this protein.

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