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PREPARE study BMJ Blog and how these two are related

Primary pREvention strategies at the community level to Promote treatment Adherence to pREvent cardiovascular disease.

Dr Dominic Misquith Principal Investigator and Dr Twinkle and Dr Farrah are con-investigators of this study.A household-level cluster-randomized trial to evaluate primary prevention interventions in CVD in three rural communities (population of 15,000).

Dr Richard Smith from the UIH Ovations Group. Dr Auun Chokalingam and Dr Cristina fronm the NHLBI were in Bangalore last weekto inaugurate our NIH Centre of Excellence. Since one of projects is to train and use community health workers to screen and monitor Hypertensions treatment in rural areas, Dominic took them to Mugalur. They were much impressed.says Dr Prem Pais

Richard Smith: A day in village India

The village is the real India,” said an Indian friend, echoing Gandhi and the continuing belief of many Indian intellectuals. “What is the village but a sink of localism, a den of ignorance, narrow mindedness, and communalism [putting your own ethnic group ahead of society],” said Bhimrao Ambedkar, who drafted the Indian constitution and was the first “untouchable” to receive an overseas education.
Both statements were in my mind as I sat in the house of the panchayet (headman) of Jagadeenahalhi, a village of about 600 people in Karnataka and close to Bangalore. I was there with two community health workers, three community health doctors from St John’s Medical College in Bangalore, a catholic college committed to serving the poor, and two colleagues from the National Institutes of Health in the US. [I may be using panchayet wrongly. It is the council of the village, and after a good bit of time on Google I’m not certain that it does mean leader. Somebody will correct me if I’m wrong, I hope.]
The panchayet was hugely jolly, laughed all the time, and seemed delighted to have us there. He is elected to his position, but serves alternating terms of five years as the role switches between “upper” and “lower” castes. As in Britain, an election is coming, and the women of the village, whom we met later, joke that this is a good time to get whatever you want.
We are there because we are starting a project to identify people in the village at high risk of cardiovascular disease and then use community health workers to help them improve their lifestyle and take any treatment that might be necessary. The panchayet is pleased that this is happening and tells us that many people in the village have “sugar diabetes” and that people are dying of heart attacks.
As we leave, he insists that we come and see his field of cabbages, which is small but well irrigated, and gives me a bag of potatoes. The village has no tarmac road but does have a primary school, and all our conversations take us back to the teacher, who is clearly a driving force in the village. We walk past the small houses, some very brightly painted, past the water tank where villagers come to collect water, and past dirty ditches filled with rubbish and murky water to the house of the leader of a local woman’s cooperative.
Almost a dozen women are sat on the floor in their brightly coloured saris, and with the community doctors translating we question them. They are a group of about 20 women from the village who all contribute 30 Rupees (around 50 p) each week to create a pool of money that is lent to members of the group to perhaps buy a goat or some seed or start a small business. The money must be paid back with interest. It’s a microfinance scheme started some nine years ago with the encouragement of the government. The women meet once a week to thrash out both business and social issues. There are eight such groups in the village.

the womens group

DrTwinkle and Dr Farrah with womens groups

They are happy to answer any question.
“Why are there no men?” “Men are too unreliable?”
“Do the men object to you forming a group?” “They did at first. Not now. They see the benefits.”
“Do you lend money for sickness?” “Yes.”
“What happens if a woman can’t pay money back?” “We give her time. We help. We’re friends.”
“Do you campaign for better facilities for the village?” “We do. We get together and go to the panchayet.”
“Can you stop the men drinking, smoking, and playing cards?” “We try, but we’re not successful.”
There’s lots of laughing as we talk.

with the health workers

Drs Rchard Smith,Dr Christina,Dr Arun at the meeting

Before we leave we sit down among them and have our photographs taken. I feel privileged to have the opportunity to meet them.
We then drive to Mugalur, a bigger village where St John’s has built a community health centre. On the way we stop at a temple with the brightly coloured, semi-naked Hindu gods swarming over the tower of the temple, monkeys joining them, and a collection of blind and elderly people begging outside. We wash our feet and hands and together—Hindus, a Muslim, some Catholics, and an atheist—receive a blessing via the priest from Krishna, who can be glimpsed deep in the temple covered in flowers.
At the clinic we meet “Dr Daisy,” known in the village as “the god of sight” who has removed over 5000 cataracts, often from people who haven’t been able to see for years. She can remove a cataract and insert an intraocular lens in about five minutes, and once did 120 in a day. “If I need a cataract removed I’ll go to her,” says one of the community health doctors.
We also meet a professor of paediatric orthopaedics who comes to the clinic once a month to see children with deformities caused by birth injury, cerebral palsy, infections, accidents, and unhealed fractures. He does such a good job that his clinic constantly grows and adults come as well, but nobody is turned way. “Consanguinous marriages are a big part of the problem” he observes.
Then we get to sit cross legged (ever tougher for my old joints) and talk to the 11 community health workers, again all women. Some of them have been working with the clinic for 13 years, doing an ever wider range of tasks. They are paid, have high status in their villages and know everything about everybody.

with the womens group

Drs Farrah,Christina with the womens group

“Doesn’t knowing so much about people mean that they respect you but keep you at a distance?” I ask, thinking of John Berger’s account of the life of a country GP.
“No, definitely not,” they answer, clearly thinking my question strange. Their value comes in large part from their intimate knowledge of their villages. “It just doesn’t work to have community health workers from other villages,” observes the community health doctor.
After answering dozens of questions from us they ask us questions. What are we expert at? My colleagues from NIH explain about their interest in chronic disease. When it’s my turn, I answer truthfully but maybe a touch pretentiously: “I’m expert at nothing but interested in everything.” This causes the translator and then the women to explode with laughter.
On our drive back the community health doctor explains that the villagers have sold all the land around their village for sums that are huge to them. A politician has bought the land and will have no difficulty getting it rezoned from agricultural land to land for development. Then he’ll build luxury houses to provide homes for the software engineers from Bangalore, which is rapidly swallowing up the surrounding countryside. The villagers, although temporarily rich, will lose income, and the traditional village will die. Worst affected will be the landless labourers who will share none of the payment for the land and the very poor, the “untouchables,” who cluster away from the village.
Eating jackfruit and reflecting as we drove back on the quotes that began this blog, I thought that I’d seen more nobility than ignorance in the villages, but will India avoid the urbanization that seems inevitably to accompany development? I doubt it.

Dr Sunil Babu In the News

KUDOS TO OUR RESEARCH DEPARTMENT. Recently, Dr. Sunil Babu and members of the research department were able to open an industry trial that may help save a young mother’s life.

On Wednesday, November 25 (the day before Thanksgiving), Babu and Leslie Edgar, RN, CS, NP, research coordinator, were able to make contact and arrangements with Alexion Pharmaceuticals to begin the regulatory process necessary to offer Eclulizumab, an investigational drug, to a 19-year-old female diagnosed with relapsed atypical hemolytic-uremic syndrome.

Atypical hemolytic-uremic syndrome (aHUS) is a serious, life-threatening condition that causes hemolytic anemia, thrombocytopenia, and kidney failure. The disease is very rare, with only three per million in children younger than 18. The incidence in adults is even rarer. Prognosis is typically poor, with most patients either dying or going into end-stage renal failure within a year of diagnosis. Babu’s patient was already on kidney dialysis and requiring blood and platelet transfusions. She had originally been diagnosed in February 2009 with the birth of her first child, but had recently relapsed and required hospitalization. She had already received standard treatment for the condition in February.

Babu determined that a new monoclonal antibody, Eculizumab, was undergoing trials in adult patients with plasma-resistant aHUS. Contact was made with Alexion Pharmaceuticals, and over the Thanksgiving holiday, regulatory documents were forwarded by Angela Hamman, data management, to Edgar. Contacts were made over home phones and by e-mail. The Western Institutional Review Board amazingly agreed to review the trial on Monday. The study “SWAT team” flew to Fort Wayne Sunday evening and arrived at our Lutheran Hospital office Monday morning to begin the patient screening process. The south office lab and pharmacy handled the pressure and extra work gracefully and without complaint. Carrie Boots, RN, NP, and Babu juggled their schedules with the help of Deborah Meyer-Vilensky, RN, to ensure that the patient and the study team were satisfied. Treatment began successfully on Tuesday, and the patient is currently doing very well and improving.

The typical industry study startup time is at least four weeks, and includes the preparation of documents, Institutional Review Board (IRB) approval, and the signing of the contract and budget. Even though we’re still tying up loose ends and trying to work through the expedited process, the research department needs to be commended for going the extra mile to ensure that the patient was given the appropriate treatment to promote the best possible outcome possible

http://www.fwmoh.com/index.php/2009/11/practice-news/

NIH &UNITED HEALTH UK selects saint Johns Medical College as centre for excelllence

NIH & United Health, UK selects St John’s Medical College as Centre for Excellence for CVD study

Friday, April 23, 2010 08:00 IST
Our Bureau, Bangalore

St John’s Medical College, recognized as one of the Centres of Excellence by the National Institute of Health (NIH), USA and the United Health UK, to carry out research on cardiovascular disease (CVD). The Bangalore-based missionary hospital is one of the 11 centres globally in the international research initiative to carry out patient studies to prevent the risk of CVD.

The five year research, viewed as one of the largest studies, will focus on ways to prevent the cardiovascular diseases, said Dr Christina Rabadan-Diehl, programme director, National Heart, Lung and Blood Institute, National Institute of Health.

“It is observed that economically backward countries are reporting a rise in CVD. Heart problems are increasing among the poor people as they are reported to suffer from stress and consume low nutrition-high fat foods from unhygienic street outlets. There is a serious lack of awareness on early detection of heart diseases and its related complications,” she added.

Further, under the initiative of the Indian Cardiologists Research Advocacy Group, St. John’s has now three research projects spread over five years to assess diseases of the heart. The projects: Inspire (Indian Stroke Prospective Registry), Spread (Secondary Prevention of Coronary Events After Discharge ) and Prepare (Primary Prevention) will help to take stock of the disease prevalence and control.

‘Inspire’ project will involve 10,500 patients at 100 hospitals in 70 cities in the country.

‘Spread’ which is Secondary Prevention of Coronary Events After Discharge from hospital will focus on clinical trials to avoid heat attacks among such patients in 10 hospitals in the country.

Under ‘Prepare’ which is a Primary Prevention strategy at the community level is designed to prevent CVD on 20,000 patients.

These studies will analyze prevention of heart disease and strokes of three rural communities in three different regions of Bangalore Rural, Rajah Muthiah Medical College in Annamalainagar near Puducherry in Tamil Nadu and Sevagram in Maharashtra, said Dr Diehl.

St John’s will now tie-up with institutions like Mahatma Gandhi Institute of Medical Sciences, Sevagram and Fortis Escorts Hospital and Research Institute, Jaipur to conduct the research.

‘Inspire’ will observe how the 10,500 patients are treated and the post discharge care protocol will be assessed. This will help to improve the treatment of stroke which usually ensues with poor after care. While ‘Spread’ will study the stroke patients, but fail to take the medicines after discharge. This project will help to improve the lifestyle and create an awareness about the medication. The key objective of ‘Prepare is to conduct a national programme to control the risk factors that will reduce the complications of CVD.

As part of the programme researchers from not only India but Argentina, Bangladesh, China, Kenya, Peru, South Africa, Guatemala, Tunisia, and US-Mexico border will meet twice a year to share the information collected.

Besides the project also aims to train the young professionals to contribute to the research apart from development of infrastructure including data management which is also on the cards.

Dr Benedict Malliakal Contributes to New Findings to stop liver disease

Rochester Contributes to New Findings to Stop Liver Disease

March 25, 2010

In a major international study, physicians have found that a drug now used to treat a complication of end-stage liver disease known as hepatic encephalopathy is useful for preventing a relapse of the condition. As a result, yesterday the U.S. Food and Drug Administration approved the drug, rifaximin, to prevent severe recurrence of the condition.

The University of Rochester Medical Center was one of 70 sites across the globe, and the only one in upstate New York, to take part in the study, which looked at a drug that has been used in Europe for many years. The results of the study were published in the March 25 issue of the New England Journal of Medicine. The study was funded by Salix Pharmaceuticals, which markets the medication.

In Rochester, 10 patients took part in the study, along with physicians and nurses in the Division of Gastroenterology and Hepatology of the Department of Medicine at the University of Rochester Medical Center. The Rochester effort was led by Benedict Maliakkal, M.D., associate professor of Medicine and medical director of Transplant Hepatology at URMC.

Maliakkal and colleagues in the United States, Canada and Russia studied 299 patients with hepatic encephalopathy, a term that describes a specific change of mental status that can occur in patients with advanced liver disease. The condition comes about because the diseased liver is unable to adequately detoxify ammonia, which is a waste product generated during protein metabolism. Ammonia and other toxins build up in the gut, enter the bloodstream and get into the brain, where at high levels they can cause symptoms like confusion, impaired memory, poor concentration, disorientation, muscle tremors, and even coma.

More than half of the patients who have cirrhosis of the liver have some form of hepatic encephalopathy, and more than 50,000 people a year in the United States are hospitalized because of the condition.

The study focused on rifaximin, an antibiotic that previously was approved in the United States only for the treatment of travelers’ diarrhea. Physicians looked at whether the medication was able to maintain remission and prevent severe recurrence of episodes of hepatic encephalopathy requiring hospitalization.

The answer was a clear “yes.” Participants who received rifaximin were about half as likely as others not on the medication to develop severe hepatic encephalopathy: 22.1 percent on the drug developed the condition, compared to 45.9 percent who received placebo. The rate of complications such as nausea, fatigue, and sleepiness was about the same in the two groups.

Importantly, most patients in the study were also on lactulose, a treatment commonly used both to treat and to prevent severe relapses of hepatic encephalopathy. But that treatment carries with it a host of unwanted side effects, including bloating, excess gas, and severe and unpredictable diarrhea, and many patients simply stop the treatment. So doctors have been searching for effective alternatives.

“Unfortunately, there is no perfect solution for patients with hepatic encephalopathy,” said Maliakkal. “Certain antibiotics like neomycin can be effective, but they can be potentially toxic to the kidneys and cause hearing loss. Lactulose is commonly used, but its side effects, such as diarrhea and bloating, are a major difficulty for patients. Rifaximin therapy looks promising as an effective way to prevent severe relapses of hepatic encephalopathy and has fewer troublesome side effects.”

http://www.miner.rochester.edu/news/story/index.cfm?id=2805

Man Fights back against pain Dr Eugene Pereria improves his quality of life

Man fights back against back pain

David Parker has his spinal cord stimulator adjusted at the office of Dr. Eugene Pereira, director of the SLUcare Pain Management Center. (Stephanie S. Cordle/P-D)

By Harry Jackson Jr.

ST. LOUIS POST-DISPATCH

02/04/2010

David Parker spent his life on his feet, working, lifting, carrying, reaching.

He didn't know until mid-2004 when he collapsed in the Home Depot parking lot, where he worked, that decades of toil had crushed a disk in his lower back.

He had back pain for years. But this was off the scale.

Doctors tried to inject a painkiller into his spine, but the disks were so close that the needle couldn't get through.

He tried surgery in 2005.

"If anything the pain was worse than before," Parker said.

'VERY HUMBLING'

He had to leave work, something worse, he said, than the damage to his back.

"One day I was the provider, I took care of my family, I bought food, kept a home for them," Parker said. "Then this happened. I went from provider to dependent — very, very humbling."

Life worsened, Parker said, when a temp worker in his surgeon's office errantly told Parker's disability insurance company that Parker could return to work.

After three years of no income while fighting to appeal the mistake, the Social Security Administration stepped in with a federal subsidy.

Depression set in. His weight went from 230 pounds to 360. He spent his day sitting, unable to move much more than to walk between rooms of his home and infrequent trips to a store. He took six to nine opiate pain killers a day.

"I'd have to come home and lay down an hour after going out," he said.

"I developed type 2 diabetes, and kept gaining.

"My (family) doctor fired me. He said if I didn't help myself, he couldn't help any more."

'GET UP AND MOVE'

Parker's only recreation was eating enormous, starchy meals in restaurants.

"My doctor said, 'I don't care how much it hurts. You have to get up and move around.'

"I had to do something," Parker said. He popped more pills and began short spells helping around the house.

He and his wife, Diane, began eating at home more often and eating less. "She got on board and she looks great," he said. "We ate better and smarter."

By early fall of last year, about 16 months after starting, he was back to 230 pounds.

"Losing the weight, has taken a lot of stress off of my back, gives me more energy and helps with the depression, better self-esteem and self worth," he said.

Feeling better, he searched for new help for his back.

In September, Parker found Dr. Eugene Pereira, director of the SLUcare Pain Management Center.

Pereira recommended a device called a spinal cord stimulator. It blocks pain by firing electronic impulses into Parker's spinal cord.

It works because pain impulses travel along a narrow route to the brain where only one signal at a time can get through, Pereira explained. The electronic pulse overrides the pain, sort of like two people unable to walk through a narrow door at the same time and the stronger person wins the shoving match.

Pereira installed the device much like he would install a heart pacemaker except the small device went into a fleshy part of Parker's backside. The doctor then threaded wires to the place where the pain originated.

'I'M MORE ALERT'

Pereira imbedded the wires into Parker's spine, where scar tissue would secure them over the next month.

Since getting the instrument, Parker said, he's down to one to two opiate painkillers a day.

"With all the drugs, there's no quality to life," he said. "I'm more alert.

"Just being able to go downstairs to my workshop for an hour a day, I'm able to be on my feet more, able to straighten up."

He still has to rest after moving around, but not as much.

"The pain isn't completely removed," he said. "But it has helped quite a bit."

The goal remains the same.

"I'm 51 years old; I'd give my right ear to go back to work," he said. "Maybe not now, but one day."

The procedure and device cost about $25,000 to $30,000, Pereira said. But it pays for itself with reduced doctor visits, treatments and medications, he said.

Pereira said he's not claiming this is better than some other methods for chronic pain, but when choosing, know that this is an option.

http://www.stltoday.com/stltoday/lifestyle/stories.nsf/healthfitness/story/F88C41B0990D608C862576BF006EDB32?OpenDocument

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