What Happens When Pay for Performance Incentives Are Withdrawn?

MedicalResearch.com Interview with:

Prof-Bruce Guthrie Head of Population Health Sciences Division Professor of Primary Care Medicine and Honorary Consultant NHS Fife

Prof. Guthrie

Prof. Bruce Guthrie PhD
Head of Population Health Sciences Division
Professor of Primary Care Medicine and Honorary Consultant NHS Fife 

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

Response: The UK Quality and Outcomes Framework (QOF)) is a primary care pay for performance programme (P4P) implemented in 2004. QOF was and still is the largest healthcare P4P programme in the world, initially having ~150 indicators and accounting for ~20% of practice income. QOF has been reduced in scale and scope over time, with 40 indicators retired in 2014. It was abolished in Scotland in 2016 and is due to be further reformed in England. There is some evidence that P4P (and QOF itself) is associated with modest improvements in quality when introduced, but little evidence about what happens when financial incentives are withdrawn.

Our study examined what happened when incentives were withdrawn in 2014 for 12 indicators where there is good before and after data. There were immediate reductions in documented quality of care, which were similar in size to improvements observed when incentives were introduced. These reductions were small to modest (~10%) for indicators relating to care that is already systematically delivered (eg routine diabetes, hypertension and cardiovascular disease) and large for indicators which has historically been less systematically delivered (eg lifestyle advice).

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Subcutaneous Emicizumab Reduces Number of Injections Needed to Control Hemophilia

MedicalResearch.com Interview with:

Dr. Johnny Mahlangu  MBBCh Faculty of Health Sciences University of the Witwatersrand and National Health Laboratory Service Johannesburg, South Africa

Dr. Mahlangu

Dr. Johnny Mahlangu  MBBCh
Faculty of Health Sciences
University of the Witwatersrand and National Health Laboratory Service
Johannesburg, South Africa

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

Response: Current unmet needs in patients with haemophilia without inhibitors are the high disease burden imposed by the frequent injections which have to be given intravensously .

Emicizumab which is given subcutaneously weekly or fortnightly aims to address these unmet needs.

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Ibudilast Slowed Brain Atrophy Progressive Multiple Sclerosis in Phase 2 Study

MedicalResearch.com Interview with:

Robert J. Fox, MD, FAAN Principal Investigator | SPRINT-MS Trial Mellen Center for MS  |  Cleveland Clinic Cleveland, OH 44195  

Dr. Fox

Robert J. Fox, MD, FAAN
Principal Investigator | SPRINT-MS Trial
Mellen Center for MS  |  Cleveland Clinic
Cleveland, OH 44195 

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

Response: The current treatment options for progressive multiple sclerosis are very limited. The SPRINT-MS trial sought to obtain proof-of-concept evidence that ibudilast has beneficial activity in progressive multiple sclerosis. In a placebo-controlled, 96-week trial of 255 people living with progressive MS, treatment with ibudilast slowed the progression of brain atrophy (brain shrinkage) by 48% compared to placebo. Side-effects of ibudilast included gastrointestinal symptoms, headache, and depression. 

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Percutaneous Repair or Medical Treatment for Secondary Mitral Regurgitation?

MedicalResearch.com Interview with:
Jean François Obadia Adult Cardiovascular Surgery and Transplantation Louis Pradel HospitalJean François Obadia MD PhD
Adult Cardiovascular Surgery and Transplantation
Louis Pradel Hospital

MedicalResearch.com: What is the background for this study?

-By definition a secondary MR concerns a normal valve or sub normal valve inside a dilated heart with poor LV function in a population of Heart failure patients. It is perfectly established today that secondary MR is a predictor of poor clinical outcomes of thissevere population.

-Therefore,it has been proposed to treat those regurgitation either by surgery (mainly the downsizing anuloplasty) or by percutaneous technique like the mitraclipwhich has been used more and more frequently recently.

-However, a beneficial effect on hardclinical outcomes has never been provedandwe still don’t know if those regurgitations need to be corrected or not, We still don’t Know if the regurgitation is the cause, the consequence or just a marker of poor prognosis.

-In this context according to the guidelines, there is a low level of evidence to support those treatments, and Europe and US Guidelines call for prospective randomized studies in this severe population.​

And this excatly what we have done with MITRA-FR

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Coronary CT Angiography May Be Best Approach to Chest Pain

MedicalResearch.com Interview with:

Prof David Newby FRSE FMedSci Personal Chair - BHF John Wheatley Chair of Cardiology University of Edinburgh

Prof. Newby

Prof David Newby FRSE FMedSci
Personal Chair – BHF John Wheatley Chair of Cardiology
University of Edinburgh

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

Response: There are many tests that can try and determine whether a patient has heart disease. All are imperfect and do not directly see if the heart arteries are diseased.

This study used a CT heart scan to see if there was any heart disease in patients who presented to the outpatient clinic with chest pains that could be due to coronary heart disease. The doctor use the scan result to decide whether they had heart disease and how to manage the patient.

The study has found that if you use a CT heart scan then you are less likely to have a heart attack in the future. In the first year, you may require treatment with an angiogram and heart surgery (stent or heart bypass) but after the first year, you are less likely to need these treatments because the disease has already been treated promptly.

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Single Dose of Ibalizumab Boosts Immunity in Resistant HIV

MedicalResearch.com Interview with:

Brinda Emu, MD Assistant Professor of Medicine (Infectious Diseases) Yale School of Medicine

Dr. Emu

Brinda Emu, MD
Assistant Professor of Medicine (Infectious Diseases)
Yale School of Medicine

MedicalResearch.com: What is the background for this study?

Response: This was a Phase 3 study of a new antiretroviral agent, ibalizumab, for the treatment of HIV-1 infection.  Ibalizumab is a monoclonal antibody that targets the CD4 receptor on host cells.  CD4 is the receptor that HIV uses to infect CD4+ T cells.  By binding to the CD4 receptor, ibalizumab prevents viral entry.  This study recruited patients that harbor multi-drug resistant HIV and were failing their current regimen of antiretroviral agents, and thus had limited options for treatment of their HIV-1 infection using approved medications.

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Elective Induction at 39 Weeks May Reduce Need for Cesarean Section

MedicalResearch.com Interview with:

George R. Saade, MD Professor Jennie Sealy Smith Distinguished Chair Professor, Obstetrics & Gynecology, and Cell Biology Chief of Obstetrics and Maternal Fetal Medicine Director, Perinatal Research Division Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine UTMB at Galveston

Dr. Saade

George R. Saade, MD
Professor Jennie Sealy Smith Distinguished Chair Professor,
Obstetrics & Gynecology, and Cell Biology
Chief of Obstetrics and Maternal Fetal Medicine
Director, Perinatal Research Division
Department of Obstetrics and Gynecology Division of Maternal Fetal Medicine
UTMB at Galveston

MedicalResearch.com: What is the background for this study?

Response: Several analyses show that the lowest risk to the baby is if delivered at 39 weeks. As pregnancy goes beyond 39 weeks, the risk to the baby increases. On the other hand, the general belief was that induction of labor at 39 increases the risk of cesarean and may not be good for the baby. The guideline were that induction without medical indication, or what we call elective induction of labor, should not be done. However, the studies on which this belief was based were not appropriately designed or analyzed. These studies compared women who were induced at 39 weeks to those who had spontaneous labor at 39 weeks. This comparison is not appropriate. While induction is a choice, having spontaneous labor at 39 weeks is not by choice.  So the correct comparison should be between women who were induced at 39 weeks to those who were not induced and continued their pregnancy beyond 39 weeks. In other words, they continued until they had spontaneous labor or developed an indication to be delivered (expectantly managed). That is how the study was done. First time pregnant women were randomized between these 2 options. The reason the study was done in first time mothers is that they have the highest risk of cesarean compared with women who had delivered vaginally before.

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Harmless or Hormone disorder?  New Test Enables Quick Diagnosis For Drinking by the Liter

MedicalResearch.com Interview with:

Prof. Dr. Mirjam Christ-Crain Professor of endocrinology, diabetes and metabolism Heads the Department of Clinical Research University and University Hospital of Basel 

Prof. Christ-Crain

Prof. Dr. Mirjam Christ-Crain
Professor of endocrinology, diabetes and metabolism
Heads the Department of Clinical Research
University and University Hospital of Basel  

MedicalResearch.com: What is the background for this study? Would you briefly explain what is meant by Diabetes Insipidus?

Response: Drinking more than three litres per day with the equivalent increase in urination is regarded as too much. This drinking by the liter – known as “polyuria polydipsia syndrome” – usually develops over time through habit, or can be a side effect of a mental illness.

In rare cases, however, it may be caused by diabetes insipidus. This is when the pituitary gland lacks the hormone vasopressin, which regulates the water and salt content in our body. Patients have a decreased ability to concentrate the urine, therefore lose a lot of fluid and have to increase their fluid intake accordingly to prevent dehydration (= Diabetes insipidus).

The distinction between what is considered a “harmless” primary polydipsia and a diabetes insipidus is crucial, as their therapy is fundamentally different. Diabetes insipidus must be treated with the hormone vasopressin, while patients with primary polydipsia require behavioural therapy to reduce their habitual drinking. A wrong therapy can have life-threatening consequences as treatment with vasopressin without indication can lead to water intoxication.

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Biomarker Procalcitonin Offered Limited Benefit Over Clinical Judgement In Antibiotic Prescribing Patterns

MedicalResearch.com Interview with:

David T. Huang, MD, MPH Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science Director, MACRO (Multidisciplinary Acute Care Research Organization) Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness) University of Pittsburgh

Dr. David Huang

David T. Huang, MD, MPH
Associate Professor, Critical Care Medicine, Emergency Medicine, Clinical and Translational Science
Director, MACRO (Multidisciplinary Acute Care Research Organization)
Director, CRISMA Administrative Core (Clinical Research, Investigation, and Systems Modeling of Acute illness)
University of Pittsburgh

MedicalResearch.com: What is the background for this study?

Response: The overuse of antibiotics has become a serious threat to global public health, causing antibiotic resistance and increasing health care costs. Physicians have long known that antibiotics are usually unnecessary for acute bronchitis and for some other cases of lower respiratory tract infections, and that antibiotics treat only bacterial infections, not viral. But in daily practice, many physicians often prescribe them.

Previous research had reported that using a biomarker blood test and following an antibiotic guideline tied to the test results could reduce antibiotic use in lower respiratory tract infections. In February 2017, the U.S. Food and Drug Administration approved the biomarker test that measures procalcitonin – a peptide that typically increases in bacterial infections, but not viral.

We conducted the Procalcitonin Antibiotic Consensus Trial (ProACT) trial to evaluate whether a procalcitonin antibiotic prescribing guideline, implemented for the treatment of suspected lower respiratory tract infection with reproducible strategies, would result in less exposure to antibiotics than usual care, without a significantly higher rate of adverse events.

The ProACT trial involved 14 predominately urban academic hospitals. We enrolled 1,656 adult patients who presented to the hospital emergency department and were initially diagnosed with a lower respiratory tract infection. All the patients were tested for their procalcitonin levels, but the results were shared only with the physicians of the patients randomly assigned to procalcitonin-guided antibiotic prescription.

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TPOXXÒ (tecovirimat): Novel Antiviral Agent in the Event of a Smallpox Epidemic

MedicalResearch.com Interview with:

This 1967 photograph, which was captured in Accra, Ghana, depicts the face of a smallpox patient CDC/ John Noble, Jr., M.D.

This 1967 photograph, which was captured in Accra, Ghana, depicts the face of a smallpox patient.

Dr. Dennis E. Hruby PhD
Chief Science Officer of SIGA Technologies
Corvallis, OR

MedicalResearch.com: What is the background for this study? 

Response: Naturally occurring smallpox was declared eradicated in 1980 following coordinated decades-long global vaccination campaigns. However, there is a significant concern that smallpox, which is both highly contagious and highly lethal, could be used as a potential bioweapon.

DNA synthesis technology and the possibility of unaccounted for smallpox stocks pose significant risks. While there are two publicly acknowledged stocks of smallpox virus held by the United States and Russia, some believe that additional stores of the virus could be in the hands of governments or organizations that might use them to cause harm. The DNA sequence of the smallpox genome is in the public domain and could potentially be synthesized in a laboratory from scratch or created by genetically modifying a similar virus.

Currently, there are no therapies approved for the treatment of smallpox infection. A smallpox bioterror attack could be especially damaging because the majority of today’s population is not immune to the virus, as routine vaccination ended in the 1970s. It is estimated that without vaccination or treatment, each person infected with smallpox would infect 5 – 7 others. Rapid spread from person-to-person can occur through speaking, breathing or touching. Smallpox also can be transmitted by direct contact with infected fluids and contaminated objects. Furthermore, vaccination must occur within 3-5 days of exposure to smallpox, when patients are still asymptomatic, to be effective. These limitations underscore the need for an effective smallpox antiviral therapy, in addition to any available vaccine.

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Enzalutamide (Xtandi) Provides Men with NonMetastatic Castration Resistant Prostate Cancer an Effective Treatment Option

MedicalResearch.com Interview with:

Maha Hussain, MD, FACP, FASCO Genevieve Teuton Professor of Medicine Division of Hematology/Oncology Deputy Director Robert H. Lurie Comprehensive Cancer Center Northwestern University Feinberg School of Medicine

Dr. Hussain

Maha Hussain, MD, FACP, FASCO
Genevieve Teuton Professor of Medicine
Division of Hematology/Oncology
Deputy Director
Robert H. Lurie Comprehensive Cancer Center
Northwestern University Feinberg School of Medicine

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

Response: Until recently patients with non metastatic castration resistant prostate cancer (nmcrpc) had no impactful systemic therapy options.  Progression to metastatic crpc; the deadly phase of the cancer, is a given in the vast majority of patients.

Enzalutamide significantly delayed the time to metastases development by almost 2 years compared to placebo with a 71% reduction in the risk of metastases or death and a median metastases free survival of 36.6 compared to 14.7 months respectively.  This was accomplished without negative impact on quality of life (qol).  Enzalutamide treated patients had a higher rate of PSA declines and delayed time to requiring other anticancer therapies.   

MedicalResearch.com: What should readers take away from your report?

Response: Androgen receptor targeting continues to be clinically relevant in this disease and the therapeutic impact is greater in earlier disease settings with lower tumor burden. This data provides men with non metastatic castration resistant prostate cancer an effective treatment option.

MedicalResearch.com: What recommendations do you have for future research as a result of this work? 

Response: In this disease setting maximizing the antitumor effect with rational combinations to increase tumor kill with the goal of further reducing the risk of metastasis and prolonging overall survival and potentially hope for “cure”. 

MedicalResearch.com: Is there anything else you would like to add? Any disclosures:

Response: On behalf of all my coauthors and study investigators I wish to thank the patients and their caregivers for participating in this trial.  Their partnership is critical to defeat prostate cancer.

Research funding to our institutions for clinical trials from Pfizer.

Citation:

Enzalutamide in Men with Nonmetastatic, Castration-Resistant Prostate Cancer

Maha Hussain, M.D., Karim Fizazi, M.D., Ph.D., Fred Saad, M.D., Per Rathenborg, M.D., Neal Shore, M.D., Ubirajara Ferreira, M.D., Ph.D., Petro Ivashchenko, M.D., Eren Demirhan, Ph.D., Katharina Modelska, M.D., Ph.D., De Phung, B.S., Andrew Krivoshik, M.D., Ph.D., and Cora N. Sternberg, M.D.
June 28, 2018
N Engl J Med 2018; 378:2465-2474
DOI: 10.1056/NEJMoa1800536

 

 

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Recombinant Polio Vaccine Improved Survival Rate Among Some With Aggressive Recurrent Brain Tumor

MedicalResearch.com Interview with:

Dr. Annick Desjardins, Assistant Professor of Medicine, photographed on October 2, 2013.

Dr. Desjardins

Annick Desjardins, M.D., F.R.C.P.C.
Associate Professor of Neurology
Associate Professor of Neurosurgery
Director of Clinical Research
The Preston Robert Tisch Brain Tumor Center at Duke
Duke University School of Medicine
Durham, NC 27710

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

Response: The poliovirus receptor (CD155) is an onco-fetal cell adhesion molecule with widespread expression in all solid tumors and particularly in primary CNS tumors (adult and pediatric).

Recombinant nonpathogenic polio–rhinovirus chimera (PVSRIPO) was generated by replacing a critical piece of the genetic information from the Sabin type 1 polio vaccine, making PVSRIPO incapable of harming or killing normal brain cells, but toxic/lethal in cancer cells. In preclinical models, it has been demonstrated that the infection of tumor cells, leads to the release of danger signals, which triggers a recruitment of dendritic/CD4/CD8 T cells and a destruction of tumor cells by anti-tumor T cells.

The manuscript reports the results of the phase 1 trial of PVSRSIPO in recurrent WHO grade IV malignant glioma patients. Adult patients with recurrence of a single glioblastoma lesion, 1-5.5cm in dimension, in a non-eloquent area of the brain, were enrolled on study. PVSRIPO is injected slowly over 6.5 hours directly into the tumor via a small catheter inserted via a small bur hole. Once intratumoral injection is completed, the catheter is removed and patients are observed for localized tumor inflammation, followed by tumor contraction. A total of 61 patients were treated on study, 9 patients in a dose escalation phase and 52 in a dose expansion phase. Side effects observed were in relation to the localized inflammation of the tumor and depending on the cerebral functions in close proximity to the tumor: headaches, visual field changes, hemiparesis, etc.

One patient experienced a brain hemorrhage at the time of catheter removal, which triggered right sided weakness and aphasia. The patient remained alive 57.5 months after PVSRIPO infusion at data cutoff of March 20th, 2018. Two on-study death were observed, a patient died from cerebral edema and seizures, which was later found to be due to tumor progression, and one patient died from the complications of an intracranial hemorrhage while receiving anticoagulation and bevacizumab.

The median overall survival among all 61 patients who received PVSRIPO was 12.5 months (95% CI, 9.9 to 15.2), comparatively to 11.3 months (95% CI, 9.8 to 12.5) in a historical control group of patients treated at Duke and who would have met eligibility on trial, would have the trial been available to them.

At 24 months, the survival plateaued in patients treated with PVSRIPO with an overall survival rate of 21% (95% CI, 11 to 33) at 24 months and 36 months in PVSRIPO treated patients, while overall survival in the historical control group continued to decline, with an overall survival rates of 14% (95% CI, 8 to 21) at 24 months and 4% (95% CI, 1 to 9) at 36 months in the historical control group.  Continue reading

Closed-Loop Diabetes Systems (Artificial Pancreas) Can Be Used For Inpatient Care

MedicalResearch.com Interview with:

Roman Hovorka PhD FMedSci Director of Research University of Cambridge Metabolic Research Laboratories  Wellcome Trust-MRC Institute of Metabolic Science Addenbrooke’s Hospital Cambridge

Dr. Hovorka

Roman Hovorka PhD FMedSci
Director of Research
University of Cambridge Metabolic Research Laboratories
Wellcome Trust-MRC Institute of Metabolic Science
Addenbrooke’s Hospital
Cambridge

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

Response: Inpatient diabetes is generally not managed well when patients are admitted for a range of health issues on the general ward.

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Bezafibrate: Potential Treatment for PBC and Itching From Biliary Disease

MedicalResearch.com Interview with:

Dr Christophe Corpechot Centre de Référence Maladie Rares: Maladies Inflammatoires des Voies Biliaires et Hépatites Auto-immunes (MIVB-H) Filière Maladies Rares: Maladies Rares du Foie de l’Adulte et de l’Enfant Hôpital Saint-Antoine (APHP) et Sorbonne Universités Paris

Dr. Corpechot

Dr Christophe Corpechot
Centre de Référence Maladie Rares: Maladies Inflammatoires des Voies Biliaires et Hépatites Auto-immunes (MIVB-H)
Filière Maladies Rares: Maladies Rares du Foie de l’Adulte et de l’Enfant
Hôpital Saint-Antoine (APHP) et Sorbonne Universités
Paris

MedicalResearch.com: What is the background for this study?

Response: Primary biliary cholangitis (PBC, previously known as “primary biliary cirrhosis”) is a rare, chronic, slowly progressive liver disease of unknown cause, mainly affecting women of middle age. It is characterized by serum marks of autoimmunity (specific auto-antibodies), chronic inflammation and destruction of small intra-hepatic bile ducts, and consequent bile secretion impairment (chronic cholestasis) leading to the progressive development of cirrhosis and liver failure. Ursodeoxycholic acid (UDCA) is the only first-line approved treatment for PBC. It improves the biochemical measures of cholestasis and prolongs survival without liver transplantation. However, 30% to 40% of UDCA-treated patients continue to have clinically significant abnormalities of their biochemical liver tests and those patients remain at high risk of developing end-stage liver disease complications.

Recently (2016), obeticholic acid (OCA) in association with UDCA has been conditionally approved in patients with an inadequate response to UDCA. This approval (FDA, EMA) was based one the results of a 1-year randomized, double-blind, placebo-controlled trial of OCA in patients with an incomplete response or intolerance to UDCA (POISE trial). In this trial, OCA was shown to improve the biochemical features of cholestasis (alkaline phosphatase (ALP) level < 1.67 times the upper limit of the normal range and a reduction of at least 15% from baseline) but was associated with a significant increase of pruritus, a characteristic, potentially debilitating symptom of PBC. BEZURSO is the first ever placebo-controlled phase 3 trial of a fibrate (a class of drugs known to be agonists of the peroxisome proliferator-activated receptors alpha) in PBC. In this 2-year randomized double-blind trial, 100 patients with an incomplete response to UDCA were assigned to bezafibrate 400 mg/day (n=50) or placebo (n=50), all in association with continued UDCA therapy.

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Family-Support Intervention in ICUs Increased Patient Comfort and Reduced Costs

MedicalResearch.com Interview with:

Douglas B. White, M.D., M.A.S. Director of the Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center’s Program on  Ethics and Decision Making in  Department of Critical Care Medicine University of Pittsburgh 

Dr. White

Douglas B. White, M.D., M.A.S.
Director of the Clinical Research Investigation and Systems Modeling of Acute Illness (CRISMA) Center’s Program on
Ethics and Decision Making in  Department of Critical Care Medicine
University of Pittsburgh 

MedicalResearch.com: What is the background for this study? 

Response: We set out to test the effectiveness of PARTNER (PAiring Re-engineered ICU Teams with Nurse-driven Emotional Support and Relationship-building). PARTNER is delivered by the interprofessional team in the ICU, consisting of nurses, physicians, spiritual care providers, social workers and others who play a part in patient care. The program is overseen by nurse-leaders in each ICU who receive 12 hours of advanced communication skills training to support families. The nurses meet with the families daily and arrange interdisciplinary clinician-family meetings within 48 hours of a patient coming to the ICU. A quality improvement specialist helps to incorporate the family support intervention into the clinicians’ workflow.

PARTNER was rolled out at five UPMC ICUs with different patient populations and staffing. It was implemented in a staggered fashion so that every participating ICU would eventually get PARTNER. Before receiving PARTNER, the ICUs continued their usual methods of supporting families of hospitalized patients. None of the ICUs had a set approach to family communication or required family meetings at regular intervals before receiving PARTNER. A total of 1,420 adult patients were enrolled in the trial, and 1,106 of these patients’ family members agreed to be a part of the study and its six-month follow-up surveys. The patients were very sick, with about 60 percent dying within six months of hospitalization and less than 1 percent living independently at home at that point.

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More Young Women Than Men Now Get Lung Cancer

MedicalResearch.com Interview with:
“Woman smoking” by Pedro Ribeiro Simões is licensed under CC BY 2.0Ahmedin Jemal, DVM, PHD
Scientific Vice President, Surveillance & Health Services Rsch
American Cancer Society, Inc.
Atlanta, GA 30303

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

Response: Historically, lung cancer rates have been higher in men than women at all ages because of the substantially higher cigarette smoking prevalence in men.

However, cigarette smoking prevalences over the past few decades have become similar between young men and women. Consistent with this pattern, we previously reported the convergence of lung cancer rates between young men and young women. In this paper, we examined the lung cancer incidence rates in young women versus young men in the contemporary cohorts.

We found that the historically higher lung cancer incidence rates in young men than in young women have reversed in whites and Hispanics born since the mid-1960s. However, this emerging incidence patterns were not fully explained by sex difference in smoking prevalence as cigarette smoking prevalences among whites and Hispanics were not higher in young women than young men.

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Study Confirms Dupilumab Reduces Asthma Exacerbations

MedicalResearch.com Interview with:

Mario Castro, M.D., M.P.H. Alan A. and Edith L. Wolff Professor of Pulmonary and Critical Care Medicine, Professor of Medicine, Pediatrics, and Radiology Washington University School of Medicine 

Drr. Castro

Mario Castro, M.D., M.P.H.
Alan A. and Edith L. Wolff Professor of Pulmonary and Critical Care Medicine,
Professor of Medicine, Pediatrics, and Radiology
Washington University School of Medicine 

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

Response: This is a confirmatory phase 3 pivotal study that assessed the efficacy and safety of dupilumab in a population of uncontrolled moderate to severe asthmatics.

This was the largest phase 3 placebo controlled trial conducted in this population evaluating a biologic. It enrolled patients without any minimum requirement for any type of biomarker such as blood eosinophils. It clearly confirmed the efficacy of dupilumab in reducing severe asthma exacerbations, improving lung function, asthma control and quality of life in the overall population. It also showed that patients with evidence of type 2 inflammation (increased blood eosinophils or exhaled NO) had a greater magnitude of effect.

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Benefits of Clopidogrel and Aspirin In Minor Stroke and High-Risk TIA

MedicalResearch.com Interview with:

Dr. S. Claiborne "Clay" Johnston MD, PhD Dean Vice President for Medical Affairs Frank and Charmaine Denius Distinguished Dean’s Chair Dell Medical School The University of Texas at Austin

Dr. Johnston

Dr. S. Claiborne “Clay” Johnston MD, PhD
Dean
Vice President for Medical Affairs
Frank and Charmaine Denius Distinguished Dean’s Chair
Dell Medical School
The University of Texas at Austin

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

Response: Prior studies have shown that the risk of a stroke or other ischemic events is high in the days to weeks after a TIA or minor stroke.

We sought to test whether blocking platelet aggregation more effectively with clopidogrel plus aspirin could reduce this risk compared to aspirin alone.  We found that the combination did reduce risk of major ischemic events.  It also showed a small increase in risk of major hemorrhage, but for most people the benefits would outweigh the potential risk.

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Alzheimer Study: New Drug Did Not Reduce Cognitive Decline

MedicalResearch.com Interview with:
Dr. Michael F. Egan MD

Merck & Co.
North Wales, PA 19454  

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

Response: A leading theory of Alzheimer’s Disease is that it is caused by the buildup of amyloid plaques in the brain. Amyloid is composed of a sticky peptide called Abeta.  Abeta production can be blocked by Inhibiting an enzyme called BACE.  In animal models, BACE inhibtion prevent amyloid accumulation.  We aimed to see if a potent BACE inhibitor would slow clinical decline in Alzheimer’s Disease.

EPOCH was a Phase 2/3 randomized, placebo-controlled, parallel-group, double-blind study evaluating efficacy and safety of two oral doses of verubecestat an investigational BACE inhibitor, administered once-daily versus placebo in patients with mild-to-moderate AD currently using standard of care treatment. The primary efficacy outcomes of the study are the change from baseline in cognition (assessed using the Alzheimer’s Disease Assessment Scale Cognitive Subscale, or ADAS-Cog),  as well as the change from baseline in function (assessed using the Alzheimer’s Disease Cooperative Study – Activities of Daily Living, or ADCS-ADL)  after 78 weeks of treatment.

Following the recommendation of the external Data Monitoring Committee (eDMC), which assessed overall benefit/risk during  the trial,  the study was stopped early, as there was “virtually no chance of finding a positive clinical effect.”

Verubecestat did not reduce cognitive or functional decline in patients with mild-to moderate Alzheimer’s disease and was associated with treatment-related adverse events.  Continue reading

Stroke: Which Clot Buster Drug Works Best?

MedicalResearch.com Interview with:

A/Prof Bruce Campbell MBBS(Hons), BMedSc, PhD, FRACP

Dr. Campbell

A/Prof Bruce Campbell MBBS(Hons), BMedSc, PhD, FRACP
Consultant Neurologist, Head of Stroke
Department of Neurology, Royal Melbourne Hospital
Principal Research Fellow,Melbourne Brain Centre @ RMH
Department of Medicine
University of Melbourne Australia 

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

Response: Patients with stroke due to a large blood vessel in the brain receive a clot-dissolving medication followed by clot retrieval surgery performed via an angiogram. The standard clot dissolving medication “alteplase” rarely opens the artery prior to clot retrieval surgery. Tenecteplase is genetically modified form of alteplase that may be more effective and is widely available (it is the standard clot dissolving medication used for heart attacks). It can be given over 10 seconds instead of the 1 hour required to infuse alteplase, meaning that patients can be transferred between hospitals to receive treatment more easily. Tenecteplase is also less expensive than alteplase.

In EXTEND-IA TNK we found that tenecteplase doubles the number of patients who have blood flow restored to the brain earlier than is possible with clot retrieval surgery (22% vs 10%) and improves patient outcomes compared to the current standard medication called alteplase.

1 in 5 tenecteplase treated patients have blood flow rapidly restored and do not require clot retrieval surgery compared to 1 in 10 with alteplase.

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White Coat Hypertension Is Not Harmless

MedicalResearch.com Interview with:
“Blood Pressure” by Bernard Goldbach is licensed under CC BY 2.0José R. Banegas, M.D.
Department of Preventive Medicine and Public Health
Universidad Autónoma de Madrid
Madrid, Spain

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

Response: Population-based studies and a few relatively small clinical investigations have defined the prognostic role of ambulatory blood pressure monitoring (ABPM) in hypertensive patients. However, previous studies were mostly limited by relatively small number of outcomes.

Our study is the largest worldwide and provides unequivocal evidence that ABPM is superior to clinic pressure at predicting total and cardiovascular mortality across a wide range of clinical scenarios – the differences are striking. Also, whether white-coat hypertension is a benign phenotype is still debated.

Our study demonstrates that white-coat hypertension was not benign. Lastly, masked hypertension patients (clinic BP normal but ABPM elevated) experienced the greatest risk of death.   Continue reading

Obese Children Who Lose Weight Before Adulthood Can Reduce Risk of Diabetes

MedicalResearch.com Interview with:

Lise Geisler Bjerregaard PhD

Dr. Geisler Bjerregaard

Lise Geisler Bjerregaard PhD
Postdoc, PhD, M.Sc. Public Health
Center for Klinisk Forskning og Sygdomsforebyggelse/ Center for Clinical Research and Disease Prevention
Sektion for Klinisk Epidemiologi
Frederiksberg Hospital, Frederiksberg

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

Response: Being overweight in childhood and early adulthood is associated with an increased risk of developing type 2 diabetes in adulthood. We wanted to know whether or not remission of overweight before early adulthood can reduce the risks of type 2 diabetes later in life.

We studied the associations between different combinations of weight status in childhood, adolescence and early adulthood, and later development of type 2 diabetes.

We found that men who had been overweight at 7 years of age but normalised weight by age 13 years and were normal weight as young men had similar risks of type 2 diabetes as men who were never overweight. Men who normalised weight between age 13 years and early adulthood had increased risks of type 2 diabetes, but lower risks than men who were overweight at all ages.  Continue reading

Zika Birth Defects More Severe When Mothers Infected During First Trimester

MedicalResearch.com Interview with:

This image depicts a posterior view of a patient’s back, captured in a clinical setting, upon presenting with this blotchy rash. After a diagnostic work-up, it was determined that the rash had been caused by the Zika virus. Note: Not all patients with Zika get a rash CDC image

This image depicts a posterior view of a patient’s back, captured in a clinical setting, upon presenting with this blotchy rash. After a diagnostic work-up, it was determined that the rash had been caused by the Zika virus.
Note: Not all patients with Zika get a rash
CDC image

Professor Bruno Hoen, M.D., Ph.D
Dept of Infectious Diseases, Dermatology, and Internal Medicine
University Medical Center of Guadeloupe 

MedicalResearch.com: What is the background for this study?

Response: Zika virus (ZIKV) infection during pregnancy has been identified only recently to cause severe birth defects, including microcephaly, other brain defects, and the congenital Zika syndrome. However, the magnitude of this risk was not clearly defined, with discrepancies between observational data from Brazil and the U.S. Zika Pregnancy Registry. We implemented a cohort study of pregnant women who have been exposed to ZIKV throughout the outbreak that hit the Caribbean in 2016.
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Quadrupling Inhaled Steroids May Abort Some Asthma Attacks

MedicalResearch.com Interview with:
“Asthma Inhaler” by NIAID is licensed under CC BY 2.0Timothy Harrison, MBBS, BSc, FRCP, MD, MSc
Professor and Honorary Consultant
Faculty of Medicine & Health Sciences
University of Nottingham

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

Response: Self management plans are recommend for patients with asthma but previous studies have shown that doubling the dose of inhaled steroids when asthma starts deteriorating is ineffective at preventing the development of an exacerbation.

This study shows that quadrupling the dose is effective and in a real-life setting can reduce severe exacerbations by about 20%

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Balanced IV Fluids Can Reduce Kidney Damage and Death in Critically Ill Patients

MedicalResearch.com Interview with:

Todd W. Rice, MD, MSc Associate Professor of Medicine Director, Vanderbilt University Hospital Medical Intensive Care Unit Division of Allergy, Pulmonary, and Critical Care Medicine Nashville, TN  

Dr. Rice

Todd W. Rice, MD, MSc
Associate Professor of Medicine
Director, Vanderbilt University Hospital Medical Intensive Care Unit
Division of Allergy, Pulmonary, and Critical Care Medicine
Nashville, TN  

MedicalResearch.com: What is the background for this study?

Response: Our study (called the SMART study) evaluates the effects of different types of intravenous fluids used in practice in critically ill patients.  It is very similar to the companion study (called the SALT-ED study and published in the same issue) which compares the effects of different types of intravenous fluids on non-critically ill patients admitted to the hospital.  Saline is the most commonly used intravenous fluid in critically ill patients.  It contains higher levels of sodium and chloride than are present in the human blood.  Balanced fluids contain levels of sodium and chloride closer to those seen in human blood.

Large observational studies and studies in animals have suggested that the higher sodium and chloride content in saline may cause or worsen damage to the kidney or cause death.  Only a few large studies have been done in humans and the results are a bit inconclusive.

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