Canadian Researcher

Clinical Research Coordinator Handbook, 5th edition

noreply@blogger.com (BASIM IBRAHM) — Mon, 31 May 2021 07:20:00 +0000

“This extremely useful title is written for anyone planning to implement clinical trials at an institution. … the author has carefully detailed the types of forms, study records, and case report forms. … A powerful appendix and glossary of relevant terms help make this a needed book for any clinical trials office.”
— Journal of Hospital Librarianship

In this fully revised and expanded fifth edition of the essential reference for clinical research coordinators, Deborrah Norris provides expanded coverage of CRC duties and regulatory requirements, including new sections on investigator responsibilities, data clarification, and adverse event reporting. The book's five appendices include a directory of CRC resources, updated forms and checklists, state regulatory requirements and contact information, conversion charts and tables, and a glossary.

This book covers these topics and more:

Federal Regulations/GCP and ICH Guidelines
Clinical Research Coordinator Responsibilities
Investigator Responsibilities
Obtaining Informed Consent/Assent
Creating and Examples of Source Documents
Electronic Data Capture (EDC)
Preparing for Regulatory Inspections
Reporting Study Results

Single-Case Research Designs: Methods for Clinical and Applied Settings

noreply@blogger.com (BASIM IBRAHM) — Wed, 19 May 2021 07:00:00 +0000

Kazdin's text is a notable contrast to the quantitative methodology approach that pervades the biological and social sciences. The methodology in Single-Case Reasearch Designs focuses on a widely applicable methodology for evaluating interventions, such as treatment, or psychotherapy, using applied behavior anlaysis. However, this revision aims to encompass a broader range of research areas that utilize single-case designs. The text will convey the pertinence of this research methodology to disciplines ranging from psychology and medicine to business and industry. The first edition of this book, which was published in 1982, still sells a steady amount of copies today. The fact that professors continue to use the first edition of this book more than twenty years after it was published is a testament to the quality of information, organization, and narrative throughout the text. The possibility of a revision has professors excited that they can expose their students to a well-written, clear, and updated text that will reflect the current status of single-case research.

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The Clinical Research Associate (CRA) Career & Beyond

noreply@blogger.com (BASIM IBRAHM) — Sat, 15 May 2021 15:32:00 +0000

The Bio Pharmaceutical industry and the drug development sector in particular is a VERY CLOSED industry and difficult to penetrate. For most graduates, the role of a Clinical Research Associate is the first step into the lucrative drug development sector of the Bio Pharmaceutical industry. For readers new to the clinical research industry and the bio pharmaceutical drug development in general, this book gives you a detailed picture of the role of the CRA and may serve as your career guide into this lucrative industry. For the experienced CRAs this book shows you the way forward beyond a CRA career within the clinical research industry. Reading this book you will understand why demand and hiring of Clinical Research Associates has continued to grow year after years despite an economic crisis in all other areas of the world economy. What awaits your career beyond a CRA within the drug development industry years ahead. This book shows readers the future of the clinical research industry. it shows projected clinical research market growth and trends in the foreseeable future. The Clinical Research Associate (CRA) career and Beyond. INSIDE THE LUCRATIVE BIO PHARMACEUTICAL INDUSTRY will help readers answer the following 7 KEY QUESTIONS about the CRA career. 1. What is a Clinical Research Associate (CRA)? 2. Why Do We Perform Clinical Research? 3. What Is The Value And Importance Of A CRA? 4. Who Can be a CRA? Pre-Requirements and Qualifications. 5. How to become A CRA? Ways on how to get into the CR industry 6. Where Is Best To Be A CRA? Contract Research Organization (CRO) or Bio-Pharmaceutical Industry (Sponsors). 7. What Are The Open Career Options Beyond A CRA? For those CRAs with the ambition to grow and develop within the bio-pharmaceutical industry and clinical research in particular, what are the future opportunities and options. Possible career growth options are detailed in the book. In addition the book gives readers an insight about CRA salaries with year 2015 CRA salary benchmark.

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Novartis $2 million gene therapy for rare disorder is world's most expensive drug

noreply@blogger.com (BASIM IBRAHM) — Thu, 30 May 2019 08:01:00 +0000

Novartis $2 million gene therapy for rare disorder is world's most expensive drug

Swiss drugmaker Novartis on Friday won U.S. approval for its gene therapy Zolgensma for spinal muscular atrophy (SMA), the leading genetic cause of death in infants, and priced the one-time treatment at a record $2.125 million.The Food and Drug Administration approved Zolgensma for children under the age of two with SMA, including those not yet showing symptoms. The approval covers babies with the deadliest form of the inherited disease as well as those with types where debilitating symptoms may set in later.“This is potentially a new standard of care for babies with the most serious form of SMA,” said Dr. Emmanuelle Tiongson, a pediatric neurologist at Children’s Hospital Los Angeles who has provided Zolgensma to patients under an expanded access program. “The job now is trying to negotiate with insurers that this would be a long-term savings.”Novartis executives defended the price, saying that a one-time treatment is more valuable than expensive long-term treatments that cost several hundred thousand dollars a year.

Gut enzymes convert donor blood to much-needed universal type O

noreply@blogger.com (BASIM IBRAHM) — Sat, 25 Aug 2018 06:51:00 +0000

TORONTO — Canadian researchers believe they have found the means to convert any type of blood into universally usable group O with enzymes found in the human gut — a finding that could expand the pool of potential blood donors and make blood-matching easier and safer.

For transfusions to be safe, blood from a donor — for instance, A, B or AB types — must match that of a patient. O-type blood can be transfused into anyone and is always in high demand.

"Blood type is determined by the presence of antigens on the surface of red blood cells; type-A blood has the A antigen, B has the B antigen, AB blood has both antigens and O blood has none," said lead researcher Stephen Withers, a professor of chemistry and biochemistry at the University of British Columbia.

"Antigens can trigger an immune response if they are foreign to the body, so transfusion patients should receive either their own blood type, or type O to avoid a reaction," he said. "That's why O blood is so important."

Withers said the UBC team sampled DNA from millions of microorganisms found in various environmental samples to find one in which the desired enzymes might be found.

The researchers then turned their attention to the mucosal lining of the human gut — which contains sugars similar in structure to blood antigens — by extracting bacterial DNA from fecal samples.

"By homing in on the bacteria feeding on those sugars, we isolated the enzymes the bacteria use to pluck off the sugar molecules," said Withers, adding that researchers then used E. coli bacteria as "little factories" to produce quantities of the enzymes "and found that they were capable of performing a similar action on blood antigens.

"So we just simply add them to the red blood cells, they attach themselves to the surface of the red blood cell and then they cut the sugar off," he said Wednesday in an interview from Boston, where the research was presented at this week's American Chemical Society annual meeting.

Scientists have been studying the use of enzymes to modify blood since 1982, said Withers. "However, these new enzymes can do the job 30 times better."

The UBC team focused on transforming A-type blood into O-type. Enzymes to snip sugars off the surface of B-type blood cells had already been identified, so using both groups of enzymes together could convert AB blood to O, he noted.

Withers and his colleagues plan to apply for a patent on the newly identified enzymes and are set to work with Canadian Blood Services and the Centre for Blood Research to test them on different types of blood from a variety of donors.

"The next step is very much all about safety," he said. "There are further tests we need to do to make sure that in the process we've not inadvertently changed anything else on the red blood cell surface which could be deleterious to its function."

One advantage of these enzymes is that they work in whole blood, not just components of blood, meaning that donations could be quickly converted to universal type O, he suggested.

"So I could imagine that what could happen is it could be added to blood when it's donated and just left sitting there to do its conversion while this stuff is being stored."

Canadian Blood Services said 46 per cent of Canada's population has group-O blood, while 42 per cent is group A, nine per cent group B, and three per cent group AB.

"One of the main challenges with maintaining an adequate blood supply in developed countries is that the use of group O is not in proportion to the incidence of that blood group in the population," said CBS chief scientist Dr. Dana Devine, who called the blood-converting enzymes a potential "game-changer."

"This imbalance arises because group O blood can be transfused to any recipient and is used to treat patients in emergency settings when there is no time to determine the patient's actual blood type," she said in a statement. While it would be unnecessary to modify all non-O blood units, Devine said the technology will be important in settings where there are anticipated shortages of group O, including Canadian summers marked by increased motor vehicle accidents, as well as hurricane season in the Caribbean and troop deployments to combat zones.

Expanding global blood supply is critical in light of growing populations and the frequency of natural disasters, Withers agreed.

Sheryl Ubelacker, The Canadian Press

Dutch medical trial using Viagra stopped after 11 babies die

noreply@blogger.com (BASIM IBRAHM) — Wed, 25 Jul 2018 14:07:00 +0000

A Dutch trial with the drug best known under the brand name Viagra, has been immediately halted after 11 babies of mothers using the medication died, one of the participating hospitals said on Tuesday.

When the trial was stopped on Monday, roughly half of 183 pregnant women participating were taking sildenafil, the Amsterdam University's Academic Medical Centre (AMC) said.

A similar Canadian study has been halted because of the Dutch findings, although the researchers say there have been no negative side effects reported in that study.

A professor at the University of British Columbia confirmed 21 Canadians have been taking part in the trial. They were recruited in 2017 under Health Canada approval, with funding from the Canadian Institutes of Health Research.

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The Canadian trial's principal investigator, Dr. Ken Lim, said all three recruiting sites in Canada have been suspended.

"We are not aware of an increase in adverse outcomes," among the Canadian participants," Lim said in a statement.

"We contacted the one Canadian woman who was currently in the trial, directing her to stop taking the drug or placebo."

The Dutch study started in 2015 and involved 11 hospitals. It was designed to look at possible beneficial effects of increased blood flow to the placenta in mothers whose unborn babies were severely underdeveloped.

Viagra turns 15, but has it helped couples’ sex lives?

Around 15 women who took the medication have not yet given birth.

"Previous studies have shown that sildenafil would have a positive effect on the growth of babies. The first results of the current study showed that there may be adverse effects for the baby after birth," the AMC said.

Unauthorized prescription drugs seized in Richmond may pose serious risks, Health Canada says

Yet the results showed that 17 babies were born with lung conditions and 11 died. Among the roughly equal control group, just three babies had lung problems and none died.

Among the women taking sildenafil, 11 of the babies died due to "a possibly related lung condition" that caused high blood pressure in the lungs and may have resulted from reduced oxygen levels.

'We cannot take chances'

An interim analysis found that the chance of blood vessel disease in the lungs "appears to be greater and the chance of death after birth seems to have increased. The researchers found no positive effect for the children on other outcomes," the AMC said.

Stephen Evans, a professor of pharmacoepidemiology at the London School of Hygiene and Tropical Medicine, said the small number of trials with pregnant women has limited our knowledge of medicines in pregnant women.

"There have been other studies in this area, both involving preliminary work using animals and using pregnant women, and there was no indication that the treatment was dangerous based on previous research," he said.

UBC's Lim said although there were no known negative reactions in Canada, "we cannot take any chances with the health of mothers and their infants," and researchers will look into previous studies on sildenafil.

"We are working co-operatively with our international research partners in the Netherlands, the United Kingdom, Australia and New Zealand to better understand the cause of the results in the Netherlands, and how they relate to results being reported by U.K. and other researchers, which did not indicate any evidence of harm," Lim stated.

Sildenafil was originally developed by Pfizer but is now off patent and available as a generic. Pfizer had no immediate comment.

Boys should be given HPV jab, says vaccine committee. Here’s what happens next.

noreply@blogger.com (BASIM IBRAHM) — Mon, 23 Jul 2018 06:42:00 +0000

It’s nearly a decade since the human papillomavirus (HPV) vaccine was first introduced in the UK to help protect against the virus that causes most cases of cervical cancer. But until now, it has only been routinely offered to girls.Today, the Joint Committee for Vaccination and Immunisation (JCVI) recommended that adolescent boys should now also receive the vaccine.When and how this will happen is now down to the Government. But the recommendation comes from years of mounting evidence around likely health benefits and overall cost effectiveness.

HPV and cancer

HPV is a big family of viruses. There are more than 100 different types and some are more dangerous than others. While some low-risk types cause growths like warts or verrucas, there are thirteen high-risk types that are linked to cancer.HPV is very common, with 8 in 10 people infected at some point in their life. Usually our bodies clear the infection without it causing any problems. But in some cases a lasting infection can lead to cancer.This is because the virus damages the infected cells’ DNA and causes them to start dividing out of control, setting them on the road to cancer.Thanks to the vaccination programme, many people know that HPV causes cervical cancer – in fact it’s linked to all cases of the disease in the UK. But HPV is linked to other cancers too – including anal, penis and some types of mouth and throat cancer.

Why wasn’t the HPV vaccine always available for boys?

The HPV vaccine protects against 4 types of HPV. Two are linked to cancer: HPV 16 and 18, which together cause around 7 in 10 cervical cancer cases in the UK. The vaccine also protects against HPV 6 and 11, which cause most genital warts.The vaccine has been available to girls in the UK since 2008. It was initially only recommended for girls as the strongest evidence of health benefits and cost effectiveness was for cervical cancer and genital warts.Since the vaccine was introduced, we’re starting to see HPV infections in people who have been vaccinated falling. This suggests the vaccine is preventing HPV infection and, in the future, this should prevent cervical cancers.But HPV is linked to cancers in men as well as women.Men who have sex with women will get some protection from the current vaccination programme if their partner is vaccinated. The same can’t be said for adult men who have sex with men .In 2015, the JCVI, which advises UK health departments on vaccines, recommended extending vaccination to adult men who have sex with men. This group of men are at a higher risk of anal cancer. Up to the age of 45, these men can request HPV vaccination at sexual health clinics.But up until today, the programme hadn’t been recommended for boys, as the JCVI weren’t convinced it would be cost-effective.Today’s decision brings the UK in line with other countries including the US and Australia, which already offer the vaccination to boys.

Who will be offered the vaccine?

The JCVI has recommended the vaccine for boys aged 11-13, similar to the vaccination programme for girls. HPV vaccination is most effective in people who haven’t ever had an HPV infection. And as HPV is mostly transmitted through close sexual contact, vaccination is offered at a young age when people are unlikely to have had any sexual experiences.Men above the vaccination age who don’t have sex with men won’t be offered the vaccine. But it’s important to remember that most people clear HPV infections without them causing any symptoms or problems. And for most cancers linked to HPV there are also other ways to reduce your risk through things like not smoking or drinking less alcohol.

What happens now?

The recommendation for a gender neutral vaccination programme for adolescents has been years in the making. The next step is for the Government to formally accept the recommendation and extend the programme to boys.Until it does, we won’t know the details of when and how the programme will be rolled out. Once they have accepted the recommendation, the Government must publish a plan and timetable for the roll-out.This will need to be accompanied by more details on the programme itself. When the vaccine was first offered to girls in the UK, a ‘catch-up’ programme was introduced for girls up to the age of 18, and we want the Government to do the same for boys.Finally, the programme will do nothing if people aren’t aware it’s happening. We want to see a national awareness campaign to clearly communicate about the vaccine and its potential benefits, as well as new information for parents and boys.By offering the vaccine to everyone aged 11-13, the number of cases of HPV, along with the cancers they cause, could be dramatically reduced in the future.

FDA Approves Krintafel (tafenoquine) for the Radical Cure of Plasmodium vivax Malaria

noreply@blogger.com (BASIM IBRAHM) — Mon, 23 Jul 2018 06:16:00 +0000

GSK and Medicines for Malaria Venture (MMV) today announced that the United States Food and Drug Administration (FDA) has approved, under Priority Review, single-dose Krintafel (tafenoquine) for the radical cure (prevention of relapse) of Plasmodium vivax (P. vivax) malaria in patients aged 16 years and older who are receiving appropriate antimalarial therapy for acute P. vivax infection.Dr. Hal Barron, Chief Scientific Officer and President of Research and Development, GSK, said: “Today’s approval of Krintafel, the first new treatment for Plasmodium vivax malaria in over 60 years, is a significant milestone for people living with this type of relapsing malaria. Together with our partner, Medicines for Malaria Venture, we believe Krintafel will be an important medicine for patients with malaria and contribute to the ongoing effort to eradicate this disease.”

Dr. David Reddy, Chief Executive Officer of MMV said: “The US FDA’s approval of Krintafel is a major milestone and a significant contribution towards global efforts to eradicate malaria. The world has waited decades for a new medicine to counter P. vivax malaria relapse. Today, we can say the wait is over. Moreover, as the first ever single-dose for this indication, Krintafel will help improve patient compliance. We are proud to have worked side-by-side with GSK for more than a decade to reach this point. Our focus is now on working to ensure the medicine reaches the vulnerable patients that need it most.”

The approval was based on efficacy and safety data from a comprehensive global clinical development P. vivax radical cure programme designed in agreement with the FDA. Thirteen studies in healthy volunteers and patients directly supported the programme. The primary evidence for the clinical efficacy and safety of the 300mg single-dose, to which more than 800 subjects were exposed, was provided by three randomised, double-blind studies: DETECTIVE Part 1 and Part 2 (TAF112582) and GATHER (TAF116564). The results of the two phase III studies were announced in June 2017. The submission included data analysed from a total of thirty-three studies involving more than 4,000 trial subjects exposed to the 300mg single-dose and other doses of tafenoquine.With the approval of Krintafel, the FDA awarded GSK a tropical disease priority review voucher. The tropical disease priority review voucher programme is designed to encourage development of new drugs and biological products for prevention and treatment of certain neglected tropical diseases affecting millions of people throughout the world.The new drug application (NDA) was submitted by GSK to the FDA in November 2017 and a regulatory submission was also made to the Australian Therapeutics Good Administration (TGA) in December 2017. A decision from the TGA is awaited. Approvals by FDA and TGA will be informative to other regulatory agencies for their own approval process in malaria-endemic countries where tafenoquine will be provided as a not-for-profit medicine to maximise access to those who need it most.

About Krintafel (tafenoquine)

Krintafel is an 8-aminoquinoline derivative with activity against all stages of the P. vivax lifecycle, including hypnozoites. It was first synthesised by scientists at the Walter Reed Army Institute of Research in 1978. GSK’s legacy in the research and development of tafenoquine as a potential medicine for malaria commenced over 20 years ago. In 2008, GSK entered into a collaboration with the not-for-profit drug research partnership, MMV, to develop tafenoquine as an anti-relapse medicine for patients infected with P. vivax. The tafenoquine clinical programme is part of GSK’s global health programme aimed at improving healthcare for vulnerable populations.

Important Safety Information

CONTRAINDICATIONS

Krintafel should not be administered to:

patients who have glucose-6-phosphate dehydrogenase (G6PD) deficiency or have not been tested for G6PD deficiency
patients who are breastfeeding a child known to have G6PD deficiency or one that has not been tested for G6PD deficiency
patients who are allergic to tafenoquine or any of the ingredients in Krintafel or who have had an allergic reaction to similar medicines containing 8-aminoquinolines.

WARNINGS AND PRECAUTIONS

Hemolytic Anemia Breakdown of red blood cells (hemolytic anemia) may occur in a patient who has G6PD deficiency. G6PD testing must be performed before prescribing Krintafel. Treatment with Krintafel is contraindicated in patients with G6PD deficiency or unknown G6PD.

G6PD Deficiency in Pregnancy or Lactation The use of Krintafel during pregnancy may cause hemolytic anemia in a G6PD-deficient fetus. Krintafel is not recommended during pregnancy. Females of reproductive potential should avoid pregnancy or use effective contraception for 3 months after the dose of Krintafel.

A G6PD-deficient infant may be at risk for hemolytic anemia from exposure to Krintafel through breast milk. Infant G6PD status should be checked before breastfeeding begins. Krintafel is contraindicated in breastfeeding women when the infant is found to be G6PD deficient or the G6PD status of the infant is unknown. A woman with a G6PD-deficient infant or if the G6PD status of the infant is not known should not breastfeed for 3 months after the dose of Krintafel.

Methemoglobinemia Asymptomatic elevations in methemoglobin have been observed in the clinical trials of Krintafel. Physicians should carefully monitor individuals with nicotinamide adenine dinucleotide (NADH)-dependent methemoglobin reductase deficiency and advise patients to seek medical attention if signs of methemoglobinemia occur.

Psychiatric Effects Serious psychiatric adverse reactions have been observed in patients with a previous history of psychiatric conditions at doses higher than the approved dose. The benefit of treatment with Krintafel must be weighed against the potential risk for psychiatric adverse reactions in patients with a history of psychiatric illness. Due to the long half-life of Krintafel (15 days), any signs or symptoms of psychiatric adverse reactions that may occur could be delayed in onset and/or duration.

Hypersensitivity Reactions Serious hypersensitivity reactions (e.g., angioedema) have been observed with administration of Krintafel. Due to the long half-life of Krintafel (15 days), any signs or symptoms of hypersensitivity adverse reactions that may occur could be delayed in onset and/or duration. Physicians should advise patients to seek medical attention if signs of hypersensitivity occur.

ADVERSE REACTIONS

The most common adverse reactions (≥5%) observed for Krintafel in clinical trials were dizziness, nausea, vomiting, headache, and decreased hemoglobin.

DRUG INTERACTIONS

Physicians should avoid coadministration of Krintafel with drugs that are substrates of organic cation transporter-2 (OCT2) or multidrug and toxin extrusion (MATE) transporters (for example, dofetilide, metformin).

To report SUSPECTED ADVERSE REACTIONS, contact GlaxoSmithKline at 1-888-825-5249 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

GSK - a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. For further information please visit www.gsk.com

Medicines for Malaria Venture (MMV) - MMV is a leading product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and facilitating delivery of new, effective and affordable antimalarial drugs.

Since its foundation in 1999, MMV and partners have built the largest portfolio of antimalarial R&D and access projects ever assembled, and brought forward seven new medicines that are already saving lives. MMV's success is based on its extensive partnership network of around 160 active pharmaceutical, academic and endemic-country partners in more than 55 countries.

MMV's vision is a world in which innovative medicines will cure and protect the vulnerable and under-served populations at risk of malaria, and help to ultimately eradicate this terrible disease.

Cautionary statement regarding forward-looking statements

GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described under Item 3.D 'Principal risks and uncertainties' in the company's Annual Report on Form 20-F for 2017.

Source: GSK

Posted: July 2018

FREE ONLINEULTRASOUND COURSES

noreply@blogger.com (BASIM IBRAHM) — Sun, 11 Mar 2018 06:20:00 +0000

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Each course contains highly relevant contents in the medical education of ultrasound. Topics range from echocardiography including TEE to critical care (emergency), vascular and abdominal ultrasound. We can help you reach your personal goals: prepare for exams, improve your medical, clinical and diagnostic skills. Our training sessions include high-quality video lectures, cases, webinars, quizzes and an instant review of your performance. Are you are interested in an hands-on-training course? We offer special live course offers to our members. So start now and get instant access! Benefit from state-of-the-art education in medicine and become an ultrasound expert the smart way: online, anywhere, anytime you please! Our research-based and practice-proven education in medicine helps you to reach your goals. We won’t overload you with overcrowded slides, complex statistics and endless rows of numbers. Each course is fun, inspiring, emotional, practical and rich in examples and cases. How does our 123 approach differ from other approaches? Check it out:

ACP Recommends Less-Intensive HbA1c Target for T2D No proof of benefit for targets below 7%, new guidelines say

noreply@blogger.com (BASIM IBRAHM) — Sat, 10 Mar 2018 05:52:00 +0000

New type 2 diabetes guidelines from the American College of Physicians (ACP) recommend less-intensive blood sugar control for most patients, with a glycated hemoglobin (HbA1c) target between 7% and 8%.

"Studies have not consistently shown that intensive glycemic control to HbA1c levels below 7% reduces clinical microvascular events, such as loss or impairment of vision, end-stage renal disease, or painful neuropathy, or reduces macrovascular events and death," said first author Amir Qaseem, MD, PhD, ACP vice president for clinical policy, and colleagues.

To develop the new recommendations, the authors evaluated six sets of current guidelines from other organizations and reviewed five important clinical trials on which those guidelines are based. The updated guidance, published online in Annals of Internal Medicine, offers four key statements:

Statement 1: Clinicians should personalize goals for glycemic control in patients with type 2 diabetes on the basis of a discussion of the benefits and harms of pharmacotherapy, patients' preferences, patients' general health and life expectancy, treatment burden, and costs of care
Statement 2: Clinicians should aim to achieve an HbA1c level between 7% and 8% in most patients with type 2 diabetes
Statement 3: Clinicians should consider de-intensifying pharmacologic therapy in patients with type 2 diabetes who achieve HbA1c levels less than 6.5%
Statement 4: Clinicians should treat patients with type 2 diabetes to minimize symptoms related to hyperglycemia and avoid targeting an HbA1c level in patients with a life expectancy less than 10 years due to advanced age (80 years or older), residence in a nursing home, or chronic conditions (such as dementia, cancer, end-stage kidney disease, or severe chronic obstructive pulmonary disease or congestive heart failure) because the harms outweigh the benefits in this population

Qaseem et al reviewed and scored currently available guidelines using the AGREE II(Appraisal of Guidelines for Research and Evaluation II) instrument. This tool asks 23 questions about central aspects of recommendations, including their scope and purpose, stakeholder involvement, rigor of development, clarity of presentation, applicability, and editorial independence. The authors scored each guideline independently, and then compared the scores.

The two lowest-scoring guidelines were from the American Association of Clinical Endocrinologists/American College of Endocrinology (AACE/ACE) and the American Diabetes Association (ADA). Both scored lowest on stakeholder involvement, applicability, editorial independence, and scientific rigor.

"Several factors were important in considering guideline quality," the authors said. "For example, although many guidelines described benefits, adverse effects, and the strength and limitations of evidence or linked the evidence to the recommendation, they often inadequately described how they had considered or weighted these factors in developing the final recommendations. The guidelines frequently relied on selective reporting of studies or outcomes and focused on relative versus absolute effects and asymptomatic surrogate measures rather than patient-centered health outcomes."

The five clinical trials reviewed were:

ACCORD (Action to Control Cardiovascular Risk in Diabetes)
ADVANCE (Action in Diabetes and Vascular Disease: Preterax and Diamicron Modified Release Controlled Evaluation)
VADT (Veterans Affairs Diabetes Trial)
Both UKPDS (United Kingdom Prospective Diabetes Study) trials

"Collectively, these trials showed that treating to targets of 7% or less compared with targets around 8% did not reduce death or macrovascular events over about 5 to 10 years of treatment but did result in substantial harms, including but not limited to hypoglycemia," the authors wrote. "No trials show that targeting HbA1c levels below 6.5% in diabetic patients improves clinical outcomes, and pharmacologic treatment to below this target has substantial harms."

The ACP recommendation to de-escalate therapy in patients who achieve HbA1c levels less than 6.5% is notably different from other guidelines, said David Lam, MD, of Icahn School of Medicine at Mount Sinai in New York City, in a statement. "This may change how some providers care for patients who are able to achieve this level of control. However, it is important to also consider what potential impact the subsequent increase in HbA1C level may have on the patient's quality of life and their perception of overall health."

The recommendation against a specific HbA1C target in patients with limited life expectancy and multiple comorbidities is another difference, he continued. "While many providers likely already adjust their A1C goals in this subset of patients, this guideline may further change the care in this group of patients."

Qaseem and co-authors concluded: "The ACP believes that clinicians should reevaluate HbA1c levels and revise treatment strategies on the basis of changes in the balance of benefits and harms due to changed costs of care and patient preferences, general health, and life expectancy."

‘Magic’ blood test could make bone marrow transplants for blood cancer safer

noreply@blogger.com (BASIM IBRAHM) — Tue, 14 Feb 2017 21:39:00 +0000

A blood test could help predict the risk of complication following a bone marrow transplant in some blood cancer patients, according to a new US study.

The test could help identify which patients given a transplant are likely to develop a potentially fatal complication, the researchers report in The Journal of Clinical Investigation Insight

(link is external)

"The test worked in different hospitals and in different groups of patients in the US and Europe, suggesting that it could be used widely" – Professor Ronjon Chakraverty, Cancer Research UK

In doing so, the test could “allow early intervention and potentially save many lives”, said lead researcher Professor James Ferrara from Mount Sinai School of Medicine(link is external).

Bone marrow transplants, in which a patient’s blood stem cells are replaced with those from a donor, are given to some patients with blood cancer to cure their disease. But around half of patients who receive the procedure develop a serious and often fatal complication called graft-versus-host disease (GVHD).

This happens when the donated immune cells recognise the patient’s body as a threat and launch an attack against it, causing inflammation that sometimes doesn’t respond to treatment.

For this latest study, researchers from 11 cancer centres in the US and Europe looked at blood samples from almost 1,300 bone marrow transplant patients to see if they could predict whether a patient will develop GVHD, and also their outlook.

They developed a test, called ‘MAGIC’ (Mount Sinai Acute GVHD International Consortium), looked at four different molecules in the blood. The researchers found that measuring the levels of two of these molecules – ST2 and REG3a – just one week after the transplant procedure, could help identify those at high risk of developing the complication and dying.

Researchers at Mount Sinai are now using these results to design clinical trials looking into whether certain immunotherapy drugs, normally given at the onset of GVHD, could improve the outlook for some patients if given earlier on, after the test identifies them as high risk.

Professor Ronjon Chakraverty(link is external), a Cancer Research UK expert on stem cell transplants, said: “This study reveals that a blood test performed just one week following a bone marrow transplant accurately identifies which patients are at the greatest risk of this life-threatening condition.

“Importantly, the test worked in different hospitals and in different groups of patients in the US and Europe, suggesting that it could be used widely. Tests such as this could spot patients who are most at risk, and make sure they get special targeted treatment before GVHD develops.”

References

Hartwell, M. J. et al. (2017). An early-biomarker algorithm predicts lethal graft-versus-host disease and survival. JCI Insight.

FDA Approves Viekira XR

noreply@blogger.com (BASIM IBRAHM) — Sat, 30 Jul 2016 12:02:00 +0000

AbbVie Receives U.S. FDA Approval of Once-Daily Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) for the Treatment of Genotype 1 Chronic Hepatitis C

NORTH CHICAGO, Ill., July 25, 2016 /PRNewswire/ -- AbbVie (NYSE: ABBV), a global biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved a New Drug Application (NDA) for Viekira XR (dasabuvir, ombitasvir, paritaprevir and ritonavir) extended-release tablets. Viekira XR is a once-daily, extended-release co-formulation of the active ingredients in Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) and is for the treatment of patients with chronic genotype 1 (GT1) hepatitis C virus (HCV) infection, including those with compensated cirrhosis (Child-Pugh A). Viekira XR is not for people with decompensated cirrhosis.

Viekira XR is the first co-formulated three direct-acting antiviral (DAA) treatment for adult patients with GT1 HCV. Viekira XR is given once-daily as three oral tablets and must be taken with a meal. It is used without ribavirin (RBV) in GT1b patients and in combination with twice daily RBV in GT1a patients. The approval is supported by Phase 3 clinical trials for Viekira Pak which include data that demonstrated 100 percent sustained virologic response 12 weeks following treatment (SVR12) in GT1b patients with 12 weeks of therapy without ribavirin and 95 percent SVR12 in GT1a patients when used with ribavirin for 12 or 24 weeks of therapy.

"AbbVie's work continues to contribute to the transformation of hepatitis C care through our focus on evolving our current therapies as part of our ongoing commitment to patients," said Rob Scott, M.D., vice president, development and chief medical officer, AbbVie. "The approval of Viekira XR provides a new treatment option for genotype 1 hepatitis C patients in the U.S. with clinical trial data using the components of Viekira XR demonstrating 100 percent cure rates in genotype 1b patients."

There are six major HCV genotypes (GT1-6) and GT1 is the most prevalent form of HCV in the U.S., accounting for approximately 74 percent of all cases.1 Hepatitis C continues to be an important public health issue, with the Centers for Disease Control and Prevention (CDC) estimating that in the U.S. approximately 2.7 million people are chronically infected with HCV.2

The approval of Viekira XR is supported by data from seven Phase 3 clinical trials in more than 2,300 patients who received Viekira Pak with or without RBV for 12 or 24 weeks and two bioavailability studies comparing the formulations.

About Clinical Studies

The components of Viekira XR (administered twice daily with a meal) have been studied in seven Phase 3 clinical trials where 1076 subjects (including 181 with compensated cirrhosis) received the recommended regimen of Viekira +/? RBV for 12 weeks, or for 24 weeks in GT1a patients with compensated cirrhosis. Ninety-five to 100 percent achieved SVR12, which means the hepatitis C virus is not detectable in the blood three months after treatment ends. Cure rates varied by the subtype of hepatitis C and whether or not the person had cirrhosis. Individual results may vary.

USE

Viekira XR (dasabuvir, ombitasvir, paritaprevir, and ritonavir) extended-release tablets/Viekira Pak (ombitasvir, paritaprevir, and ritonavir tablets; dasabuvir tablets) (Viekira) are prescription medicines used with or without ribavirin to treat adults with genotype 1 chronic (lasting a long time) hepatitis C (hep C) virus infection.

Viekira can be used in people who have compensated cirrhosis.

Viekira is not for people with advanced cirrhosis (decompensated). If people have cirrhosis, they should talk to a doctor before taking Viekira.

About Viekira XR

The components of Viekira XR* have been studied in a broad range of genotype 1 (GT1) patients with chronic hepatitis C virus (HCV) infection, ranging from treatment-naïve to difficult to treat patients, such as those with compensated (mild, Child-Pugh A) cirrhosis of the liver, HCV/HIV-1 co-infection, liver transplant recipients with normal hepatic function and mild fibrosis, and those who have failed previous treatment with pegylated interferon (pegIFN) and ribavirin (RBV).

The extended-release co-formulation of these components, Viekira XR, consists of 200 mg of dasabuvir, 8.33 mg of ombitasvir, 50 mg of paritaprevir, and 33.33 mg of ritonavir per tablet, and is dosed three tablets once daily. Viekira XR must be taken with a meal, and tablets should be swallowed whole. People should not drink alcohol within four hours of taking Viekira XR. Viekira XR is contraindicated in patients with moderate to severe hepatic impairment (Child-Pugh B and C) due to risk of potential toxicity. Viekira XR is taken for 12 weeks, except in GT1a patients with cirrhosis and all liver transplant recipients with normal hepatic function and mild fibrosis, who should take it for 24 weeks. Ribavirin should be co-administered in GT1a patients and in all patients who have received a liver transplant.

Paritaprevir was discovered during the ongoing collaboration between AbbVie and Enanta Pharmaceuticals (NASDAQ: ENTA) for HCV protease inhibitors and regimens that include protease inhibitors. Paritaprevir is used in combination with AbbVie's ombitasvir with or without dasabuvir for the treatment of hepatitis C.

*Given as a fixed-dose combination of ombitasvir 25mg (an NS5A inhibitor), paritaprevir 150mg (an NS3/4A protease inhibitor), and ritonavir 100mg (an HIV-1 protease inhibitor), dosed once daily with a meal, and dasabuvir 250mg (a non-nucleoside NS5B palm polymerase inhibitor), dosed twice daily with a meal.

About AbbVie's Patient Assistance Program

AbbVie supports patient assistance programs to help qualified people access their needed AbbVie medication at no cost. In 2015, more than 81,000 U.S. patients received AbbVie's medicines at no cost3. For those who qualify, AbbVie plans to offer a patient assistance program for people taking Viekira XR. Since Viekira Pak's approval in 2014, AbbVie has supported access to medication for those living with chronic HCV and facing financial difficulties.

About AbbVie's HCV Clinical Development Program

AbbVie's HCV clinical development program is intended to advance scientific knowledge and the clinical care of people with chronic HCV infection. AbbVie is investigating a pan-genotypic (genotypes 1-6) regimen and is in Phase 3 of clinical development. For more information on AbbVie Phase 3 HCV studies, visit www.clinicaltrials.gov (NCT02243293).

About HCV

Hepatitis C is inflammation of the liver caused by an infection with the hepatitis C virus. It is transmitted when an infected person's blood enters the bloodstream of an uninfected person. The Centers for Disease Control (CDC) estimates that approximately 2.7 million people have chronic HCV infection in the U.S. There are six major HCV genotypes (GT1-6), with genotype 1 (GT1) as the most prevalent form in the U.S. It is estimated that of people infected with chronic HCV, about 5 to 20 percent will go on to develop cirrhosis over a period of 20–30 years, and with HCV-related liver transplants on the rise, HCV is a critical public health issue. Presently, there is no vaccine for HCV infection.

About AbbVie

AbbVie is a global, research-based biopharmaceutical company formed in 2013 following separation from Abbott Laboratories. The company's mission is to use its expertise, dedicated people and unique approach to innovation to develop and market advanced therapies that address some of the world's most complex and serious diseases. Together with its wholly-owned subsidiary, Pharmacyclics, AbbVie employs more than 28,000 people worldwide and markets medicines in more than 170 countries. For further information on the company and its people, portfolio and commitments, please visit www.abbvie.com. Follow @abbvie on Twitter or view careers on our Facebook or LinkedIn page.

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry.

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2015 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law.

1 Wedemeyer H. Hepatitis C. Chapter 80: In: Feldman M, Friedman LS, Brandt LJ, eds. Sleisenger and Fordtran's Gastrointestinal and Liver Disease. Vol 2. 10th ed. Philadelphia, PA: Saunders Elsevier; 2016.
2 Centers for Disease Control and Prevention (CDC). Hepatitis C FAQs for health professionals. http://www.cdc.gov/hepatitis/hcv/hcvfaq.htm#section1. Accessed June 9, 2016.
3 AbbVie 2016 Impact by the Numbers. http://www.abbvie.com/responsibility/home.html

SOURCE AbbVie

FDA Approves Adlyxin

noreply@blogger.com (BASIM IBRAHM) — Sat, 30 Jul 2016 11:54:00 +0000

Sanofi Receives FDA Approval of Adlyxin (lixisenatide) for Treatment of Adults With Type 2 Diabetes

PARIS, July 27, 2016 /PRNewswire/ -- Sanofi announced today that the U.S. Food and Drug Administration (FDA) approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes.

"The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," said Peter Guenter, Executive Vice President, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled."

The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA's request to demonstrate CV safety. The GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for Adlyxin included nausea, hypoglycemia and vomiting.

Adlyxin will be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will also receive a disposable pre-filled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days. On Day 15, patients will increase dosage to 20 micrograms once daily.

Adlyxin is approved under the proprietary name, Lyxumia® in more than 60 countries and marketed in over 40. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. Adlyxin was in-licensed from Zealand Pharma A/S (NASDAQ OMX Copenhagen: ZEAL), www.zealandpharma.com.

About Adlyxin

Adlyxin is a once-daily glucagon-like peptide-1 receptor agonist (GLP-1 RA) for the treatment of adult patients with type 2 diabetes mellitus as an adjunct to diet and exercise. GLP-1 is a peptide hormone that is released within minutes after eating a meal. It is known to suppress glucagon secretion from pancreatic alpha cells and stimulate glucose-dependent insulin secretion by pancreatic beta cells. Adlyxin increases glucose-dependent insulin release, decreased glucagon secretion, and slows gastric emptying.

About Sanofi Diabetes & Cardiovascular

Diabetes and cardiovascular disease affect millions of people worldwide, with many managing the complex challenges of both. Building on our portfolio evolution, heritage and expertise, Sanofi has a focused business unit dedicated to delivering innovative, value-based medicines and integrated solutions in these therapeutic areas. We are committed to a collaborative approach that involves strategic alliances with professional and patient associations, research institutions and leaders in healthcare and other industries, with the goal of advancing scientific knowledge, driving the convergence of science and technology, helping to improve outcomes and inspiring an evolution in care.

About Sanofi

Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Merial. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).

Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words "expects", "anticipates", "believes", "intends", "estimates", "plans" and similar expressions. Although Sanofi's management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under "Risk Factors" and "Cautionary Statement Regarding Forward-Looking Statements" in Sanofi's annual report on Form 20-F for the year ended December 31, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

SOURCE: Sanofi

Novel Therapeutic Advances for Management of Diabetes Mellitus

noreply@blogger.com (BASIM IBRAHM) — Sun, 17 Jul 2016 08:30:00 +0000

Diabetes mellitus (DM) has become one of the most challenging health problems in the 21st century. It is a serious public health problem globally, but the good news is that various advances are being made in prevention, detection, and treatment of diabetes. Though prevention is always better than cure, yet sometimes prevention is not possible and the cure seems to take ages. The interest to find a possible cure for diabetes has eventually led to exploration of various new scientific areas of research.

Volanesorsen

Volanesorsen (formerly ISIS-APOCIIIRx)is an antisense drug in development intended to treat patients with severely high triglycerides either as a single agent or in combination with other triglyceride-lowering agents.Elevation in triglycerides has always increased the risk of cardiovascular disorders as well as type 2 diabetes mellitus (T2DM). Researchers from the University of Pennsylvania have found the therapeutic effect of lipid-lowering medication sin improving insulin sensitivity in people with T2DM. Volanesorsen is an oral medication that can help to control the blood sugar levels. Itis believed to improve the insulin sensitivity and significantly decrease the patients’ overall glycated hemoglobin (HbA1c). After taking the medication for 12 weeks, researchers found that adult T2DM patients receiving volanesorsen experienced 69% reduction in triglycerides, and 57% improvement in whole-body insulin sensitivity.Researchers concluded that decrease in triglycerides was strongly related to improved insulin sensitivity and improved HbA1c.

PEGylated Lispro

PEGylated lispro (LY2605541) has been developed by the addition of polyethylene glycol (PEG) to insulin lispro, leading to its extended half-life. Early phase evaluations of PEGyalted lispro confirm its non-inferiority to glargine with a potential weight advantage when used in T2DM. Since insulin therapy is anabolic and its initiation is commonly associated with weight gain, an insulin preparation associated with a beneficial weight profile would represent a particularly valuable therapeutic entity.

Pre-clinical studies indicate that LY2605541 has low mitogenic potency, exerting a preferential hepatic effect on glucose homeostasis. However, LY2605541 appears to cause elevated transaminases and derangement of lipid profiles. On the basis of these initial observations, LY2605541 requires further extensive clinical evaluation to fully assess its risk/benefit profile in the management ofdiabetes.

Islet Transplantation

A novel technology has been developed to help treat type 1 diabetes mellitus (T1DM) and potentially negate the need for insulin injections. Islets are organoids that produce multiple hormones, including insulin, and donated islets are already treating severe cases of T1DMeffectively. Islet transplantation can transform the lives of T1DM patients, and may result in long-term freedom from insulin injections with excellent glucose control.

Natural Products

Plants possessing antidiabetic properties may be suitable as an adjunct to the existing therapies or as a prospective source of new hypoglycemic compounds. Many new bioactive drugs isolated from plants demonstrate antidiabetic activity equal to known oral hypoglycemic agents such as tolbutamide and chlorpropamide. Several plant species with terpenoids, flavonoids, phenols, coumarins, and other bioactive constituents have shown their potency in reducing blood glucose levels. Plants likeAllium sativum(Liliaceae),Gymnema sylvestre(Asclepiadaceae),Murraya koenigii(Rutaceae),Allium cepa(Liliaceae),Withania somnifera (Solanaceae), andFerula foetida (Umbelliferae) have exhibited antidiabetic properties when assessed in experimental models of diabetes. These traditional approaches might prove to bebeneficial in treatment of diabetic complications.

Great strides have been made clinically in the management of diabetes. Extensive research may lead to discovery of newer and better options for diabetes. With new technologies revolutionizing the treatment possibilities, the search for an effective medication is not far ahead.

Turacoz Healthcare Solutions aims to create awareness for such healthcare issues like diabetes mellitus which pose a serious threat to people, irrespective of race, gender, or age. We consider it our corporate responsibility to share the knowledge related to therapeutic research and development, and keep you updated with the recent medical advancements in the healthcare industry.“Being aware of a disease and its deleterious consequences”is the first-step towards its prevention. So stay healthy and stay long.

Fascinating Facts About Your Body

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 12:29:00 +0000

Even though you’re around human bodies all day (after all, you have one of your very own), you probably don’t know everything there is to know about them. Each of our bodies are a miracle; it’s amazing they work the way they do, day in and day out. If you thought what our bodies could do before, once you read this list of insane facts about the human body, you’ll be in awe. Never take your own body for granted, because some of the things it can do are mind-blowing.

Does This Cause Cancer?

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 12:21:00 +0000

Cancer is a class of diseases characterized by out-of-control cell growth. There are over 100 different types of cancer, and each is classified by the type of cell that is initially affected. Cancer harms the body when damaged cells divide uncontrollably to form lumps or masses of tissue called tumors (except in the case of leukemia where cancer prohibits normal blood function by abnormal cell division in the blood stream). Tumors can grow and interfere with the digestive, nervous, and circulatory systems, and they can release hormones that alter body function. Tumors that stay in one spot and demonstrate limited growth are generally considered to be benign.

How to Have a Healthy Day From Morning to Night

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 12:07:00 +0000

We work, we plan, we organize, we go, fueling ourselves on coffee and pure determination. Until, that is, we fall onto the sofa in a stupor. More of us are struggling with energy issues, experts say; they point to the weak economy, which has us working harder and plugging in longer, and the belief that we can have it all (so what if we’re up till midnight making it happen).
“Just like houseplants need water, our energy reserves need regular replenishing,”

Protect Yourself From Medical Costs and Disability

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 11:51:00 +0000

An estimated 22.4% of women 18 years of age or older and 29.3% of women 40 years of age or older had a self-reported disability.Women 40 years of age or older with a disability were less likely to have had a mammogram (72.2%) than were women without a disability (77.8%)

Foods to Avoid If You Have High Triglycerides

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 10:07:00 +0000

When you have high triglyceride levels, there's a good chance you also have abnormal cholesterol numbers: specifically, low levels of HDL "good" cholesterol and high levels of LDL "bad" cholesterol. This combination increases the likelihood that you’ll have a heart attack orstroke.

Tips to Stay Smart, Sharp, and Focused

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 09:41:00 +0000

We all want to keep our minds sharp and fresh. By working to keep your mind sharp, you can improve your attitude. Nothing angers a person more than not being able to remember mportant things or events. By having a sharp mind you can figure situations out more effectively and make wiser decisions. There are numerous ways to keep your mind sharp while keeping a good, well-rounded attitude. Reading this article will tell you those ways.

Interactive DRI for Health Care Professional

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 09:29:00 +0000

Use this tool to calculate daily nutrient recommendations for dietary planning based on the Dietary Reference Intakes (DRIs). These represent the most current scientific knowledge on nutrient needs, developed by the National Academy of Science’s Institute of Medicine. Individual requirements may be higher or lower than the DRIs.

Mobile app now available: download from the Apple Store or Google Play.

What is a case-control study in medical research?

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 09:27:00 +0000

What is a case-control study in medical research?

Markus MacGill

A case-control study is a type of medical research investigation often used to help determine the cause of a disease, particularly when investigating a disease outbreak or a rare condition.

If public health scientists want a relatively quick and easy way to find clues about the cause of, for example, a new disease outbreak, they can compare two groups of people:

Those who already have the disease – ‘cases’
Similar people who have not been affected – ‘controls.’

A case-control study is retrospective – the researchers look back at data collected in the past, enabling them to test whether a particular outcome can be linked back to a suspected risk factor. To test for specific causes, the scientists need to formulate a hypothesis about what they think could be behind the outbreak or disease. They then compare how often the group of cases had been exposed to the suspected cause (risk factor), versus how often the controls had been exposed. If the risk factor has a greater prevalence among the cases, then this is some evidence to suggest that it is a cause of the disease.Risk factors could be uncovered by researchers studying the medical and lifestyle histories of the people in each group. A pattern may emerge that links the condition under investigation to certain factors.Case-control research is a central tool used by epidemiologists, who look into the factors that affect the health and illness of populations.Just one risk factor could be investigated for a particular disease outcome. A good example of this is to analyze how many people with lung cancer, versus how many without, have a history of smoking.

A case control study .pdf

The Truth About Probiotics and Your Gut

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 09:13:00 +0000

Probiotics are live bacteria and yeasts that are good for your health, especially your digestive system. We usually think of bacteria as something that causes diseases. But your body is full of bacteria, both good and bad. Probiotics are often called “good” or “helpful” bacteria because they help keep your gut healthy.Probiotics are naturally found in your body. You can also find them in some foods and supplements.It’s only been since about the mid-1990s that people have wanted to know more about probiotics and their health benefits. Doctors often suggest them to help with digestive problems. And because of their new found fame, you can find them in everything from yogurt to chocolate.

Healthy Living Can Prevent Cancer From Developing, Progressing, or Recurring

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 09:02:00 +0000

Many of the greatest reductions in cancer morbidity and mortality are a result of advances in cancer prevention and early detection. These advances were enabled by translating the discoveries of the causes and progressive nature of cancer into effective new clinical practices and public education and policy initiatives.Central to preventing cancer is the identification of factors that increase a person’s risk of developing cancer and eliminating or reducing these factors where possible (see Figure 4). As research has enhanced our knowledge of cancer risk factors, we have learned that more than 50 percent of the 585,720 cancer deaths expected to occur in the United States in 2014 will be related to preventable causes (16).Many factors that increase the risk of developing cancer are related to lifestyle; thus, adopting a healthy approach to living, where possible, can eliminate or reduce the risk of some cancers (seeFigure 5). Moreover, many healthy approaches to living can also reduce cancer recurrence and improve outcomes following a cancer diagnosis. However, a great deal more research and many more resources are needed to understand how best to help individuals change their lifestyle.

Adopting Healthy Approaches to Living

Tobacco use is responsible for almost 30 percent of cancer deaths each year in the United States (1) (see Figure 6). As a result, one of the most effective ways a person can lower the risk of developing cancer is to eliminate tobacco use (see sidebar on Reasons to Eliminate Tobacco Use). This relationship between tobacco use and cancer was first brought to the public’s attention 50 years ago, when the U.S. Surgeon General’s report on “Smoking and Health” was published (17). Since then, smoking rates among U.S. adults have more than halved, and as a result, an estimated 800,000 deaths from lung cancer were avoided between 1975 and 2000 (18).Unfortunately, the rate of decline in smoking prevalence in the United States has slowed in recent years (18). In fact, almost 70 million individuals age 12 or older are regular users of tobacco products (20).If we are to eradicate one of the biggest threats to public health, researchers, clinicians, advocates, and policymakers must continue to work together. Several steps that could be taken to achieve this goal are outlined in this year’s Surgeon General’s report, “The Health Consequences of Smoking—50 Years of Progress,” (see sidebar on Eliminating Tobacco Use Faster) (18). Of particular importance is the regulation of additional tobacco products by the FDA.Other healthy approaches to living that can significantly reduce cancer risk are maintaining a healthy weight, which is defined as a body mass index (BMI) between 18.5 and 24.9 kg/m2 for adults over 20 years of age; keeping active; and eating a balanced diet (see sidebar on Reasons to Maintain a Healthy Weight and Keep Active). The impact of adopting these aspects of a healthy lifestyle could be enormous because it is estimated that one-third of all new cancer diagnoses in the United States are related to being overweight or obese, not getting enough physical activity, and/or having poor dietary habits (10, 16). Moreover, more than one-third of adults, or more than 72 million individuals, and 17 percent of youth in the United States are obese (21, 22).Fortunately, regular physical activity, independent of body fatness, can decrease the risk of developing certain cancers (23). However, nearly half of adults in the United States do not meet the recommended guidelines for aerobic physical activity (25) (see sidebar on Physical Activity Guidelines). Moreover, sedentary behavior, independent of body mass and periodic physical activity, can increase the risk of developing certain types of cancer (24).

Beyond preventing the development of some cancers, following these recommendations may also improve outcomes for individuals diagnosed with certain types of cancer, in particular breast, colorectal, and prostate cancers, reducing risk of disease recurrence and metastasis and increasing chance of long-term survival (27-29).

Although small improvements in maintaining a healthy weight and increasing physical activity have been made, more action is urgently needed. Concerted efforts by individuals, families, communities, schools, workplaces and institutions, health care professionals, media, industry, government, and multinational bodies are required to develop effective and comprehensive strategies to promote the maintenance of a healthy weight and the participation in regular physical exercise. One new strategy, Park Rx, an initiative of the National Park Service seeks to encourage health care providers to help patients establish an exercise routine by effectively using their neighborhood parks.

Another way that individuals can reduce their risk of developing cancer, specifically the three main types of skin cancer—basal cell carcinoma, squamous cell carcinoma, and melanoma—is by limiting their exposure to ultraviolet (UV) radiation (see sidebar on Reasons to Protect Your Skin). In fact, the International Agency for Research on Cancer (IARC), an affiliate of the World Health Organization, considers exposure to UV radiation from any source as “carcinogenic to humans” (30), alongside agents such as plutonium and cigarettes.

Despite this, half of all adults in the United States report at least one sunburn in the past 12 months and 5 percent report using a UV indoor tanning device at least once, with many using these devices 10 or more times a year (37, 38). Moreover, 13 percent of all high school students and 21 percent of high school girls report using an indoor UV tanning device in the past year (39).Given that many cases of skin cancer are preventable, it is important that everyone work together to develop and implement more effective policy changes and public education campaigns to help reduce the health and economic burdens of the disease. For example, initiatives aimed at increasing the number of individuals who adopt sun-safe habits and tighter regulation of indoor tanning would dramatically reduce the incidence of skin cancer (see sidebar on Sun-safe Habits).

Persistent infection with a number of pathogens—bacteria, viruses, or parasites that cause disease—can result in certain types of cancer (40, 41) (see Table 4). In fact, pathogens are estimated to cause about 2 million cancer cases each year, with more than 90 percent of these cases attributable to just four pathogens—Helicobacter pylori, hepatitis B virus (HBV), hepatitis C virus (HCV), and human papilloma virus (HPV) (42) (see Figure 7).This knowledge has enabled the development of strategies to eliminate or prevent infection with these cancer-associated pathogens (see sidebar on Cancer-causing Pathogens: Prevention and Elimination). Consulting with a physician and following his or her advice regarding the use of these strategies can reduce an individual’s risk of certain cancers and is part of a healthy approach to living.

Despite the availability of strategies to eliminate or prevent infection with some cancer-associated pathogens, researchers estimate that pathogen-related cancers account for about 20 percent of cancer diagnoses worldwide (40) (see Figure 7). Thus, it is clear that these strategies are not being used optimally and that a dramatic reduction in the global cancer incidence could be achieved by more effective implementation. In fact, the CDC estimates that in 2012, only 33 percent of girls ages 13–17 in the United States had received the recommended three doses of HPV vaccine (60). Moreover, this percentage varies widely among states, with fewer than 26 percent of girls completing the vaccine course in six states, and the lowest rate being just 12.1 percent (44). Further, the “President’s Cancer Panel 2012–2013 Report” stated that in the United States alone, more than 50,000 cases of cervical cancer and thousands of cases of other types of cancer could be prevented if 80 percent of those for whom the HPV vaccine is recommended—girls and boys ages 11 and 12, respectively—were to be vaccinated (44) (see sidebar on The “President’s Cancer Panel Report”).

Research has provided and continues to increase our knowledge of the causes of cancer and the timing, sequence, and frequency of the genetic, molecular, and cellular changes that drive cancer initiation and development. This knowledge provides us with unique opportunities for developing ways to prevent cancer onset or to detect a cancer and intervene earlier in its progression. Finding a cancer early, asCongressman Ron Barber did in 2012, before it has spread to other parts of the body, makes it more likely that a patient can be treated successfully. Cancer screening is therefore an important part of a healthy lifestyle.

Screening to detect cancer in individuals showing no signs or symptoms of the disease they are being screened for can have tremendous benefits (see sidebar on Cancer Screening). However, it can also cause unintended harm, and this has made it difficult to develop strategies for screening for the majority of cancer types. For a screening program to be successful, it must meet two important criteria: It must decrease deaths from the screened cancer, and the benefits it provides must outweigh any harms. Determining whether a screening program meets these criteria requires an enormous amount of research and careful analysis of the data generated.

In the United States, an independent group of experts convened by the Public Health Service rigorously evaluates clinical research to make evidence-based recommendations about clinical preventive services, including cancer-screening tests. These experts form the U.S. Preventive Services Task Force (USPSTF). As of Aug. 1, 2014, the USPSTF recommended that certain segments of the general population be screened for just four types of cancer (see sidebar onUSPSTF Cancer-screening Recommendations). In addition to considering evidence regarding potential new screening programs, the USPSTF routinely evaluates new research regarding established screening programs, and can revise recommendations if deemed necessary.

Although cancer screening is part of a healthy approach to living, it can be difficult for individuals to ascertain which cancers to be screened for and when. The USPSTF and other relevant professional societies’ recommendations are evidence-based guidelines that can help, but they are only one factor to consider when making decisions about cancer screening.

People have their own unique risks for developing each type of cancer. These risks are determined by genetic, molecular, cellular, and tissue makeup, as well as by lifetime exposures to the large number of factors that can increase the risk of developing cancer (see Figure 4). As a result, each individual should consult with his or her physicians to develop a personalized cancer-screening plan that takes into account evidence-based recommendations; the individual’s own cancer risks, including family history; and the individual’s tolerance to specific benefits and harms of screening (see sidebar on Cancer Screening). Importantly, the risk for different types of cancer can vary over time—for example, risk for most cancers increases with age—so it is important that individuals continually evaluate, and update if necessary, their personalized cancer-screening plans.

Some generally healthy individuals are at increased risk of certain cancers because they inherited a cancer-predisposing genetic mutation (see sidebar on How Do I Know If I Am at High Risk for Developing an Inherited Cancer?). However, inheriting a cancer-predisposing genetic mutation is a relatively rare occurrence. In fact, only about 5 percent of all new cases of cancer diagnosed in the United States each year are caused by such mutations (63). To date, not all potentially inheritable causes of cancer have been identified, but if an individual suspects that a relative has a cancer caused by one of the 17 known cancer-predisposing genetic mutations (see Table 5), he or she should consult a physician and consider genetic testing for verification.

As part of a healthy approach to living, persons who are at risk for developing an inherited cancer—both those who learn they carry a known cancer-predisposing genetic mutation and those who fulfill criteria for being at risk—should consult with their doctors to determine how this influences their personalized cancer prevention and screening plans. Some patients may be able to reduce their risk of developing cancer by modifying their behaviors. Others might need to increase their participation in screening or early detection programs or even consider taking a preventive medicine or having risk-reducing surgery (see Tables 6 and 7).

Beyond inherited cancers, a number of medical conditions place an individual at higher risk for certain types of cancer. For example, ulcerative colitis and Crohn disease increase an individual’s risk for colorectal cancer sixfold, but they are relatively rare conditions (64). A far more prevalent medical condition that increases an individual’s risk for developing cancer is type 2 diabetes, which raises the risk of developing liver, pancreatic, and endometrial cancers (65, 66). These factors are important considerations when developing a personalized cancer prevention and screening plan.

A Simple Method for Evaluating the Clinical Literature

noreply@blogger.com (BASIM IBRAHM) — Sun, 20 Mar 2016 08:59:00 +0000

The “PP-ICONS” approach will help you separate the clinical wheat from the chaff in mere minutes.

Robert J. Flaherty, MD

Keeping up with the latest advances in diagnosis and treatment is a challenge we all face as phycians. We need information that is both valid (that is, accurate and correct) and relevant to our patients and practices. While we have many sources of clinical information, such as CME lectures, textbooks, pharmaceutical advertising, pharmaceutical representatives and colleagues, we often turn to journal articles for the most current clinical information.

Unfortunately, a great deal of research reported in journal articles is poorly done, poorly analyzed or both, and thus is not valid. A great deal of research is also irrelevant to our patients and practices. Separating the clinical wheat from the chaff can take skills that many of us never were taught.

KEY POINTS

Reading the abstract is often sufficient when evaluating an article using the PP-ICONS approach.
The most relevant studies will involve outcomes that matter to patients (e.g., morbidity, mortality and cost) versus outcomes that matter to physiologists (e.g., blood pressure, blood sugar or cholesterol levels).
Ignore the relative risk reduction, as it overstates research findings and will mislead you.

The article “Making Evidence-Based Medicine Doable in Everyday Practice” in the February 2004 issue of FPM describes several organizations that can help us. These organizations, such as the Cochrane Library, Bandolier and Clinical Evidence, develop clinical questions and then review one or more journal articles to identify the best available evidence that answers the question, with a focus on the quality of the study, the validity of the results and the relevance of the findings to everyday practice. These organizations provide a very valuable service, and the number of important clinical questions that they have studied has grown steadily over the past five years. (See “Four steps to an evidence-based answer.”)

FOUR STEPS TO AN EVIDENCE-BASED ANSWER

When faced with a clinical question, follow these steps to find an evidence-based answer:

Search the Web site of one of the evidence review organizations, such as Cochrane (http://www.cochrane.org/cochrane/revabstr/mainindex.htm), Bandolier (http://www.jr2.ox.ac.uk/bandolier) or Clinical Evidence (http://www.clinicalevidence.com), described in “Making Evidence-Based Medicine Doable in Everyday Practice,” FPM, February 2004, page 51. You can also search the TRIP+ Web site (http://www.tripdatabase.com), which simultaneously searches the databases of many of the review organizations. If you find a systematic review or meta-analysis by one of these organizations, you can be confident that you’ve found the best evidence available.
If you don’t find the information you need through step 1, search for meta-analyses and systematic reviews using the PubMed Web site (see the tutorial athttp://www.nlm.nih.gov/bsd/pubmed_tutorial/m1001.html). Most of the recent abstracts found on PubMed provide enough information for you to determine the validity and relevance of the findings. If needed, you can get a copy of the full article through your hospital library or the journal’s Web site.
If you cannot find a systematic review or meta-analysis on PubMed, look for a randomized controlled trial (RCT). The RCT is the “gold standard” in medical research. Case reports, cohort studies and other research methods simply are not good enough to use for making patient care decisions.
Once you find the article you need, use the PP-ICONS approach to evaluate its usefulness to your patient.

If you find a systematic review or meta-analysis done by one of these organizations, you can feel confident that you have found the current best evidence. However, these organizations have not asked all of the common clinical questions yet, and you will frequently be faced with finding the pertinent articles and determining for yourself whether they are valuable. This is where the PP-ICONS approach can help.

What is PP-ICONS?

When you find a systematic review, meta-analysis or randomized controlled trial while reading your clinical journals or searching PubMed (http://www.ncbi.nlm.nih.gov/entrez/query.fcgi), you need to determine whether it is valid and relevant. There are many different ways to analyze an abstract or journal article, some more rigorous than others.1,2 I have found a simple but effective way to identify a valid or relevant article within a couple of minutes, ensuring that I can use or discard the conclusions with confidence. This approach works well on articles regarding treatment and prevention, and can also be used with articles on diagnosis and screening.

The most important information to look for when reviewing an article can be summarized by the acronym “PP-ICONS,” which stands for the following:

Problem,
Patient or population,
Intervention,
Comparison,
Outcome,
Number of subjects,
Statistics.

For example, imagine that you just saw a nine-year-old patient in the office with common warts on her hands, an ideal candidate for your usual cryotherapy. Her mother had heard about treating warts with duct tape and wondered if you would recommend this treatment. You promised to call Mom back after you had a chance to investigate this rather odd treatment.

When you get a free moment, you write down your clinical question: “Is duct tape an effective treatment for warts in children?” Writing down your clinical question is useful, as it can help you clarify exactly what you are looking for. Use the PPICO parts of the acronym to help you write your clinical question; this is actually how many researchers develop their research questions.

You search Cochrane and Bandolier without success, so now you search PubMed, which returns an abstract for the following article: “Focht DR 3rd, Spicer C, Fairchok MP. The efficacy of duct tape vs cryotherapy in the treatment of verruca vulgaris (the common wart). Arch Pediatr Adolesc Med. 2002 Oct;156(10):971-974.”

You decide to apply PP-ICONS to this abstract (see “Abstract from PubMed”) to determine if the information is both valid and relevant.

ABSTRACT FROM PUBMED

Using the PP-ICONS approach, physicians can evaluate the validity and relevance of clinical articles in minutes using only the abstract, such as this one, obtained free online from PubMed,http://www.ncbi. nlm.nih.gov/entrez/query.fcgi. The author uses this abstract to evaluate the use of duct tape to treat common warts.

Problem. The first P in PP-ICONS is for “problem,” which refers to the clinical condition that was studied. From the abstract, it is clear that the researchers studied the same problem you are interested in, which is important since flat warts or genital warts may have responded differently. Obviously, if the problem studied were not sufficiently similar to your clinical problem, the results would not be relevant.

Patient or population. Next, consider the patient or population. Is the study group similar to your patient or practice? Are they primary care patients, for example, or are they patients who have been referred to a tertiary care center? Are they of a similar age and gender? In this case, the researchers studied children and young adults in outpatient clinics, which is similar to your patient population. If the patients in the study are not similar to your patient, for example if they are sicker, older, a different gender or more clinically complicated, the results might not be relevant.

Intervention. The intervention could be a diagnostic test or a treatment. Make sure the intervention is the same as what you are looking for. The patient’s mother was asking about duct tape for warts, so this is a relevant study.

Comparison. The comparison is what the intervention is tested against. It could be a different diagnostic test or another therapy, such as cryotherapy in this wart study. It could even be placebo or no treatment. Make sure the comparison fits your question. You usually use cryotherapy for common warts, so this is a relevant comparison.

Outcome. The outcome is particularly important. Many outcomes are “disease-oriented outcomes,” which are based on “disease-oriented evidence” (DOEs). DOEs usually reflect changes in physiologic parameters, such as blood pressure, blood sugar, cholesterol, etc. We have long assumed that improving the physiologic parameters of a disease will result in a better disease outcome, but that is not necessarily true. For instance, finasteride can improve urinary flow rate in prostatic hypertrophy, but it does not significantly change symptom scores.3

DOEs look at the kinds of outcomes that physiologists care about. More relevant are outcomes that patients care about, often called “patient-oriented outcomes.” These are based on “patient-oriented evidence that matters” (POEMs) and look at outcomes such as morbidity, mortality and cost. Thus, when looking at a journal article, DOEs are interesting but of questionable relevance, whereas POEMs are very interesting and very relevant. In the study on the previous page, the outcome is complete resolution of the wart, which is something your patient is interested in.

Number. The number of subjects is crucial to whether accurate statistics can be generated from the data. Too few patients in a research study may not be enough to show that a difference actually exists between the intervention and comparison groups (known as the “power” of a study). Many studies are published with less than 100 subjects, which is usually inadequate to provide reliable statistics. A good rule of thumb is 400 subjects.4 Fifty-one patients completed the wart study, which is a pretty small number to generate good statistics.

Statistics. The statistics you are interested in are few in number and easy to understand. Since statistics are frequently misused in journal articles, it is worth a few minutes to learn which to believe and which to ignore.

Relative risk reduction. It is not unusual to find a summary statement in a journal article similar to this one from an article titled “Long-Term Effects of Mammography Screening: Updated Overview of the Swedish Randomised Trials”

“There were 511 breast cancer deaths in 1,864,770 women-years in the invited groups and 584 breast cancer deaths in 1,688,440 women-years in the control groups, a significant 21 percent reduction in breast cancer mortality.”

This 21-percent statistic is the relative risk reduction (RRR), which is the percent reduction in the measured outcome between the experimental and control groups. (See “Some important statistics” for more information on calculating the RRR and other statistics.) The RRR is not a good way to compare outcomes. It amplifies small differences and makes insignificant findings appear significant, and it doesn’t reflect the baseline risk of the outcome event. Nevertheless, the RRR is very popular and will be reported in nearly every journal article, perhaps because it makes weak results look good. Think of the RRR as the “reputation reviving ratio” or the “reporter’s reason for ‘riting.” Ignore the RRR. It will mislead you. In our wart treatment example, the RRR would be (85 percent – 60 percent)/60 percent x 100 = 42 percent. The RRR could thus be interpreted as showing that duct tape is 42 percent more effective than cryotherapy in treating warts.

SOME IMPORTANT STATISTICS

Absolute risk reduction (ARR): The difference between the control group’s event rate (CER) and the experimental group’s event rate (EER).

Control event rate (CER): The proportion of patients responding to placebo or other control treatment. For example, if 25 patients are in a control group and the event being studied is observed in 15 of those patients, the control event rate would be 15/25 = 0.60.

Experimental event rate (EER): The proportion of patients responding to the experimental treatment or intervention. For example, if 26 patients are in an experimental group and the event being studied is observed in 22 of those patients, the experimental event rate would be 22/26 = 0.85.

Number needed to treat (NNT): The number of patients that must be treated to prevent one adverse outcome or for one patient to benefit. The NNT is the inverse of the ARR; NNT = 1/ARR.

Relative risk reduction (RRR): The percent reduction in events in the treated group compared to the control group event rate.

View/Print Table

	When the experimental treatment reduces the risk of a bad event:	Example: Beta-blockers to prevent deaths in high-risk patients with recent myocardial infarction:	When the experimental treatment increases the probability of a good event:	Example: Duct tape to eliminate common warts.
Relative risk reduction (RRR)	CER-EER/CER	(.66 -. 50)/.66 = .24 or 24 percent	EER-CER/CER	(.85-.60)/.60 = .42 or 42 percent
Absolute risk reduction (ARR):	CER-EER	(.66 – .50) = .16 or 16 percent	EER-CER	.85-.60 = .25 or 25 percent
Number needed to treat (NNT)	1/ARR	1/.16 = 6	1/ARR	1/.25 = 4

Absolute risk reduction. A better statistic is the absolute risk reduction (ARR), which is the difference in the outcome event rate between the control group and the experimental treated group. Thus, in our wart treatment example, the ARR is the outcome event rate (complete resolution of warts) for duct tape (85 percent) minus the outcome event rate for cryotherapy (60 percent) = 25 percent. Unlike the RRR, the ARR does not amplify small differences but shows the true difference between the experimental and control interventions. Using the ARR, it would be accurate to say that duct tape is 25-percent more effective than cryotherapy in treating warts.

Number needed to treat. The single most clinically useful statistic is the number needed to treat (NNT). The NNT is the number of patients who must be treated to prevent one adverse outcome. To think about it another way, the NNT is the number of patients who must be treated for one patient to benefit. (The rest who were treated obtained no benefit, although they still suffered the risks and costs of treatment.) In our wart therapy article, the NNT would tell us how many patients must be treated with the experimental treatment for one to benefit more than if he or she had been treated with the standard treatment.

Now this is a statistic that physicians and their patients can really appreciate! Furthermore, the NNT is easy to calculate, as it is simply the inverse of the ARR. For our wart treatment study, the NNT is 1/25 percent =1/0.25 = 4, meaning that 4 patients need to be treated with duct tape for one to benefit more than if treated by cryotherapy.

Wrapped up in this simple little statistic are some very important concepts. The NNT provides you with the likelihood that the test or treatment will benefit any individual patient, an impression of the baseline risk of the adverse event, and a sense of the cost to society. Thus, it gives perspective and hints at the “reasonableness” of a treatment. The value of this statistic has become appreciated in the last five years, and more journal articles are reporting it.

What is a reasonable NNT? In a perfect world, a treatment would have an NNT of 1, meaning that every patient would benefit from the treatment. Real life is not so kind (see “Examples of NNTs”). Clearly, an NNT of 1 is great and an NNT of 1,000 is terrible. Although it is hard to come up with firm guidelines, for primary therapies I am satisfied with an NNT of 10 or less and very pleased with an NNT less than 5. Our duct tape NNT of 4 is good, particularly since the treatment is cheap, easy and painless.

EXAMPLES OF NNTS

The number needed to treat (NNT) is one of the most useful statistics for physicians and patients. It calculates the number of patients that must be treated to prevent one adverse event or for one patient to benefit. Note that NNTs for preventive interventions will usually be higher than NNTs for treatment interventions. The lower the NNT, the better.

The following examples of NNTs are borrowed from an excellent list available through the Bandolier Web site at http://www.jr2.ox.ac.uk/bandolier/band50/b50-8.html.

View/Print Table

Therapy	NNT
Triple antibiotic therapy to eradicate H. pylori	1.1
Isosorbide dinitrate for prevention of exercise-induced angina	5
Short course of antibiotics for otitis media in children	7
Statins for secondary prevention of adverse cardiovascular outcomes	11
Statins for primary prevention of adverse cardiovascular outcomes	35
Finasteride to prevent one operation for benign prostatic hyperplasia	39
Misoprostol to prevent any gastrointestinal complication in nonsteroidal anti-inflammatory drug users	166

Note that NNTs for preventive interventions (e.g., the use of aspirin to prevent cardiac problems) will usually be higher than NNTs for treatment interventions (e.g., the use of duct tape to cure warts). Prevention groups contain both higher-risk and lower-risk individuals, so they produce bigger denominators, whereas treatment groups only contain diseased patients. Thus, an NNT for prevention of less than 20 might be particularly good.

When discussing a particular therapy, I explain the NNT to my patient. Since this statistical concept is easy to understand, it can help the patient be a more informed partner in therapeutic decisions.

You will soon start to see a similar statistic, the number needed to screen (NNS), which is the number of patients needed to screen for a particular disease for a given duration for one patient to benefit.6Although few NNSs have been calculated, they are likely to involve higher numbers, since the screening population consists of patients with and without the disease. For example, in the article on mammography screening mentioned above, the NNS was 961 for 16 years. In other words, you would need to screen 961 women for 16 years to prevent one breast cancer death.

The good news and the bad

Using PP-ICONS to assess the wart study, the problem, the patient/population, the intervention, the comparison and the outcome are all relevant to your patient. The number of subjects is on the small side, making you a little wary, but the intervention is cheap and low-risk. The statistics, particularly the NNT, are reasonable. On balance, this looks like a fair approach, so you call the patient’s mother and discuss it with her.

The PP-ICONS approach is an easy way to screen an article for validity and relevance, and the abstract often contains all of the information you need. Even the statistics can be done quickly in your head. You can apply PP-ICONS when searching for a particular article, when you come across an article in your reading, when data are presented at lectures, when a pharmaceutical representative hands you an article to support his or her pitch, and even when reading news stories describing medical breakthroughs.

Don’t be discouraged if you find that high-quality articles are rare, even in the most prestigious journals. This seems to be changing for the better, although many careers are still being built on questionable research. Nevertheless, screening articles will help you find the truth that is out there and will help you practice the best medicine. And as we become more discerning end-users of research, we might just stimulate improvements in clinical research in the process.

Dr. Flaherty is a family physician with the Student Health Service and WWAMI Medical Program, Montana State University-Bozeman, and a clinical professor in the Department of Family Medicine, University of Washington.