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Public Health in the News – July 26, 2015

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Public Health in the News – July 19, 2015

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Public Health in the News – July 5, 2015

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Public Health in the News – June 28, 2015

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Spotlight on Recent Research: The Long-Term Health Consequences of Bullying

By Mo McNulty

Bullying has long been recognized as a public health problem, with both victims of bullying as well as the bullies themselves experiencing health problems such as headaches and anxiety. Additionally, other studies show that bullying victims are more likely to consider suicide, and a large proportion of suicides among young people are likely linked to bullying. Now, a new study published in the BMJ has found that negative health effects caused by bullying persist for years; children who had encountered peer victimization experienced higher rates of depression as young adults.

Oxford researcher Lucy Bowes and her colleagues conducted a longitudinal observational study: they collected data on the same subjects over time. Their subjects came from the ALSPAC cohort, a group of British children who have been followed since before birth.

Bowes et al. interviewed children at the ages of 8, 10, and 13 to see how often they experienced different types of bullying. The researchers then followed up with a subset of the children five years later to determine how many experienced symptoms of depression. They found that children who were frequently victimized were more likely to be depressed at the age of 18. Furthermore, there was a dose-dependent association between bullying and depression: subjects who were bullied often were more likely to report depression than those who were only bullied occasionally.

Here’s a table showing the proportion and odds ratios of depressed teens, based on how frequently they were bullied. Their authors presented their data in both unadjusted form, as well as adjusted for various confounding factors:

Odds Ratios for Depression

The researchers also calculated the population attributable fraction, which is the amount that a given risk factor contributes to a disease. They found that 29.2% of the risk of young adult depression in their cohort could be explained by childhood bullying.

Because this was an observational trial, it was impossible for the researchers to directly determine whether the relationship between bullying and depression is causal. However, their evidence does support this notion. Additionally, the authors noted that there might be some bias in their study, as 18 year-olds from more wealthy, educated families were more likely to return to the clinic. Therefore, the sample of young adults that was tested for depression may have had different characteristics than the starting sample of children in which bullying was measured.

Although other studies have previously shown similar links between bullying and later mental health problems, this study is by far the biggest; as a result Bowes et al. were better able to adjust for some confounding factors that had limited previous studies. This study indicates that bullying prevention programs are an important public health intervention.

Bowes L, Joinson C, Wolke D, Lewis G. Peer victimisation during adolescence and its impact on depression in early adulthood: prospective cohort study in the United Kingdom. BMJ 350, h2469 (2015). PMID: 26037951


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Public Health in the News – June 21, 2015

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Building a Comprehensive Medical Records System to Improve Patient Health Outcomes

An interview with Dr. Abel Kho, Director of the recently launched Center for Health Information Partnerships (ChiP)Abel_headshotDr. Kho is a practicing physician at the Northwestern Medical Group and director of the new Center for Health Information Partnerships (CHiP) in the Institute for Public Health and Medicine at the Feinberg School of Medicine. Dr. Kho is also the principal investigator of Healthy Hearts in the Heartland, and co-executive director of the Chicago Health IT Regional Extension Center (CHITREC). His research includes creation of multi-institutional clinical data networks, health applications of geographic information systems, and data set-driven decision support.

NPHR: Tell us a bit about how you got to where you are?

Dr. Kho: I really debated whether to go to medical school and I only applied on time to one medical school. I always wanted to do something with technology. I remember while I was interviewing for my residency at the University of Michigan, the faculty member asked me, “What do you think are the two biggest innovations in health care?” And I said, “genetics and the rise of computing power”- and of course I did not get in – but I still believe that. If you look at where things are going, technology is not going to fade; it’s only going to be more and more ubiquitous and we have to do a better job and think of smarter ways to integrate technology to improve health care. Likewise we are only going to get more insight into how genetics affect our lives and health outcomes – it will happen.

How did you first get started in health informatics? 

Dr. Kho: During my chief year in Internal Medicine Residency I had a great mentor in Robert Schilling , (below with Dr.Kho) the inventor of the Schilling test for B12 deficiency and a hematologist. He and his colleague Dr. Warren Slack were professors at the University of Wisconsin – Madison where I did my residency. During my chief year I had a little bit of research time and started helping Dr. Schilling with this database that he created of all the known hereditary spherocytosis patients he had ever encountered. In exchange for working on this database, he would take me fly-fishing. So each time we went fly fishing he gave me some hand tied flies and we would have a beer and just talk about cases and career.

Dr. Kho and Dr. Robert SchillingDuring one of these sessions he told me if you are ever interested in really working on these kinds of database projects, I know this guy Clem McDonald, in Indianapolis, who is also interested in building electronic medical records, you should meet him. So I took time some time off and met Clem McDonald. He invited me to do a fellowship in informatics in Indianapolis but advised me that ultimately I should do what was best for me. During this same period, I had just finished transitioning the whole residency program to a fully online system for tracking schedules, so I realized I was starting to do more work on how to change systems to improve the way we deliver care. I had trained previously in theoretical and applied mechanics at the University of Illinois Urbana-Champaign College of Engineering before going to medical school. Coming from this background during my residency training I kept thinking, we can do these things better, and we can use technology to scale improvements up – not just for my patients but for a whole region. So at the end of my residency training I became interested in tools that allow us to scale up health care improvements. So as I moved to Indianapolis I started asking, “What are health care problems that can be fixed and scaled?” At this time I read the book “The Coming Plague” and one of the questions raised in the book is drug resistance. It led me to wonder: how do we track drug resistance? So we developed a database and alerting tools to track drug-resistant bacteria in our county hospital in Indianapolis. That project morphed and grew and now we track not only MRSA or VRE at one hospital but all major hospital systems in Indianapolis, and we also automatically track all the multidrug-resistant gram negative organisms too. That technology does not have to just exist there. Now that we have created it we want to make it available to any region, as our system is relatively portable. So we can pick up our system drop it on a local server – turn on a couple of data feeds to it and we will be able to track similar infections in this region.

How do you use technology to improve patient outcomes?

Our current approach is fairly straightforward – we start with a simple problem in health care and ask how can technologies make it more efficient and how scalable is it and then we try to solve that simple problem and scale up our solution. Another project we’ve been working on recently: a couple of years ago we got a grant to install electronic health records in Chicago (CHITREC) and at the time we had to fight resistance like, “what are you doing, this isn’t research!” Still, we believed this work was important and would help us develop a framework for capturing and better understanding health data. Over the course of this work we have developed wonderful relationships around Chicago in non-academic settings where we have installed electronic health records. These non-academic settings include all the federally qualified health centers in Chicago, and numerous small clinics scattered around the Chicago metro area. This preliminary work allowed us to successfully apply for a recent even larger grant to directly connect the data from all the local health centers around the Chicago area (about 250 clinics) to a central common node so we can start to first measure the baseline quality of care in a region and to assess the effect of clinical and population-based interventions on a region – all data collated from the interconnected network of local health centers. It took us 5 years to build the framework to ask research-relevant questions but now we have both the relationships and the resources to tackle research questions that will affect 3 states: Illinois, Wisconsin and Indiana.

What specific questions do you think this new infrastructure allows you answer?

Dr. Kho: Much of this work is at the interface between primary care and public health – a lot of the work we are doing depends on public health partners, because when you think broadly, informatics and public health are both broad system-wide approaches to solutions to problems. If we succeed we will be able to know whether data capture through routine primary care can effectively measure the health of certain populations by following and tracking the health of those populations through time and to determine if those interventions are working.

The question this approach raises is how representative of the general population is the sample captured by our electronic health records. So what we are trying to do in parallel is a validation study to determine how representative our medical records obtained data is of the general population. One validation is at the population level and the other is at the individual level. Great work done at the Alliance of Chicago has also been trying to validate these data at the individual level through interviews and public health surveys that are linked to electronic records data.

What are some challenges of managing a comprehensive medical records system?

Dr. Kho: As we have worked on this project a few challenges have emerged. And a major challenge for research based on electronic medical records is the question of unique patient identity – which comes up over and over again -particularly as we start doing work across multiple institutions. The reality is a person or people do not just interact with one health center, they interact with multiple health centers through time. The challenge becomes: how do you preserve the privacy of the individual, while preventing oversampling? So we had to design a novel approach that allowed us to do this in the past few years. This approach is now being employed by several institutions that are part of the Chicago Area Patient Centered Outcomes Research Network (CAPriCORN) (the PCORI-funded regional network of institutions that have agreed to form a clinical data network to conduct comparative effectiveness research). The long-term goal will be to integrate data from large institutional networks from groups like CAPRICORN to the data from smaller health centers from CHITREC to get a more comprehensive picture of the health of the region, and this can be used to track and measure health outcomes and intervention effectiveness. To help ensure we address any privacy concerns we are working closely with a health information privacy expert at Vanderbilt (Bradley Malin) for the past several years. He ensures the way we do our work minimizes the risk of identification and re-identification of participants. Fortunately he has been involved with writing the federal legislation on health privacy so he also ensures we are complying with federal regulations.

We are in a data age and everyone realizes the tremendous value that data has. But like all things of great value, folks that have it want to protect it and keep it for themselves. But greater value can be obtained from data when it is combined or compared with other data. To do this effectively you have to have appropriate stewardship, expertise and a human touch. So we believe the center is an opportunity to bring all the different components that make data powerful together, in a safe, secure, trusted and purposeful environment so that people can come up with and bring together their questions, methods, and data in a place where they can realize the greatest value from their data. This is important because a lot of the people who have the technical expertise don’t have access to the data and conversely a lot of the people generating valuable data don’t have the requisite tech savviness. We find that when it comes to data it is important to provide a safe stewardship environment that understands that people are dealing with something that is very valuable to them and need a relationship that provides clear value to all partners. This is a recurring theme in many of our projects.

What is the long-term goal of CHiP?

Dr. Kho: Our main goal through the center is to empower and enable a broader community than we currently have, to ask and answer their most pressing health questions. There is no upper bound to the types of questions community members might come up with. Personally, I would love to see work using these patient-based health records to result in true innovations in improving quality in clinical care. And I believe in time these resources will give us enough power to conduct certain types of analyses – particularly questions that relate to the influence of genes and environment on disease. A comprehensive, representative set of patient health records system over a diverse region like Chicago makes it more feasible to conduct studies like these.

What kinds of services are you able to offer at CHiP and what infrastructures do you have in place?

Methodology experts: we have domain experts that are important for health data projects. Privacy and security foremost. Big data analytics and folks who are really skilled at that. Epidemiologists and informatics folks who understand the key methods and also library and informatics folks who understand how to categorize and index data.

Database: We have already have built connections to extensive health records data through CAPRICORN and CHITREC and we are currently working on creating snapshots so people can get a better sense of the types of data we have as well as the geographic scope of that data especially as our data keeps expanding.

• Partners: We see an opportunity to engage industry partners; where we can’t or have not currently scaled a project, we can do so with industry partners. So what we are really hoping to engage are people, communities, methodologic experts, and data stewards as the framework of our services. Our goal is to create true partnerships that help our partners make the most of available data. We are starting off with three tracks to provide an anchor including one focused on gene-by-disease-by environment type studies.

As you look back at your career so far what lessons have stood out the most?

Dr. Kho: I think willingness to take a risk. One thing we try hard to instill in our team is the importance of taking risks and failing. A failure in one direction can be very empowering and can lead you in surprising directions. We’ve been lucky in that some risks have been really rewarding, but probability is also on your side if you fail enough times. It’s a wonderful confluence right now – it turns out that being an informatics person who is also a primary care provider is a really good thing right now and there are good funding opportunities for this type of research. I have never seen anyone succeed greatly by just following the path – it just does not happen – you have to be willing to take a risk and jump off the path.

Thanks for your time Dr. Kho.


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Public Health in the News – June 14, 2015

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Public Health in the News – June 7, 2015

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The FDA and drug shortages in remote clinics and surgical centers

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By Osefame Ewaleifoh (PhD/MPH candidate)

The problem of drug shortages remains a subtle but complex public health concern particularly for clinics in remote locations and surgical centers. Drug shortages stem from an intricate web of economic, legal, and clinical decisions that span from the need to tightly regulate the distribution of highly potent drugs to lack of infrastructure for delivering drugs to remote locations . Surgical center drug shortages  impact anesthesia and chemotherapy drugs most severely, creating problems for ambulatory surgery centers that depend heavily on these drugs for patient care. While seemingly inconsequential  drug shortages can have fatal consequences  as physicians find new substitutes for scarce drugs.

Unlike most players in the healthcare continuum,  the U.S Food and Drug Administration (FDA) is uniquely poised to lead a carefully orchestrated and multifaceted effort to manage the drug shortage crises – The sole objective of the FDA is to protect public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and 5275421991_c207c4a945_oproducts.The FDA is also responsible for coordinating federal responses to drug shortages. Thus with the growing challenge of drug shortages the pressure on the FDA has also grown . In response the FDA has taken on the herculean task of working with stakeholders such as drug manufacturers and suppliers to prevent and respond to drug shortages in surgical centers. The FDA’s working model to manage drug shortages is simple; learn about an impending drug shortage as early as possible and bring critical stakeholders like manufacturers and suppliers together to prevent or ameliorate such a potential shortage.

At the core of the push to track and prevent drug shortages is the Center for Drug Evaluation and Research (CDER) (2). The CDER tracks shortages in both prescription and over the counter medications . The CDER’s drug shortage program (DHP) receives notifications from manufacturers, Health care centers, surgical centers and wholesalers and validates this potential shortage information with manufacturers. Upon confirming shortage the CDER activates a series of tools and strategies to mitigate and limit the potential drug shortage. The FDA currently employs two main approaches to managing drug shortages; prevention of drug shortages and response to drug shortages (3) .

To prevent drug shortages the FDA has three main strategies; expediting the review and approval of new manufacturing sites and new suppliers, exercising regulatory flexibility and discretion and asking other firms to increase production. To respond to drug shortages the FDA has three main strategies; Asking other firms to increase production, expediting review of regulatory submissions and exercising regulatory discretion such as controlled importation of similar products approved abroad but not in the U.S. Other efforts by the FDA to curb the growing shortage of drugs in surgical centers include writing a letter to drug manufacturers reminding them of their current legal obligation to notify the FDA in advance of drug shortages and supporting legislation that requires early notification from manufacturers on impending drug shortages.drug supply chainThe role of the FDA as a facilitator, managing drug shortage is complicated by the lingering perception that the FDA itself is partly responsible for drug shortages because of its intense regulatory activities. Today most of the FDA’s operational powers with regards to managing drug shortages come from section 506c (4)of the FD&C act which requires the sole source manufacturer of certain drugs (life sustaining or intended for use in the prevention of debilitating disease) to notify the agency at least six months prior to the date of discontinuation of the manufacture of such a drug. However this act does not provide the FDA with any explicit enforcement authority, leaving it relatively impotent. In response to this impotence, a recent bill ( S. 296) proposed by senator Klobuchar expands the 6 month rule by requiring manufacturers of all drugs (not just life threatening drugs) to report all supply disruptions or product discontinuations that could lead to shortages six months in advance or as soon as practicable or face very stiff penalties (5).

On the executive level, the Obama administration, also recently signed an executive order directing the FDA to streamline the process of approving changes to production lines (6) . This streamlined process should make it easier for drug manufacturers to respond more rapidly to notifications by quickly ramping up production of drugs anticipated to be in short supply.While individually important, these measures by the government and FDA remain only a small part of a desperately needed multi faceted approach to stem the growing crises of drug shortages in surgical centers around the country.

While some progress has been made by the FDA, it is clear that the challenge of ending drug shortages is a very daunting task.  A look at the FDA’s public drug shortage inventory online shows that this challenge is not going away any time soon. Resolving drug shortages both  domestically and internationally will require the brilliance and ingenuity of young scientist, public health scholars and entrepreneurs who  can adapt emerging technologies and models to crack this intransigent public health conundrum.

References:

2. Center for Drug Evaluation and Research, Food and Drug Administration. Manual of Policies and Procedures (MAPP). Available at:
http://www.fda.gov/downloads/AboutFDA/CentersOffices/CDER/ManualofPoliciesProcedures/ucm079936.pdf

3. A review of FDA’s approach to medical product shortages. Press release October 31, 2011. Available at http://www.fda.gov/DrugShortageReport

4. 21 U.S.C. 356c
5. Preserving Access to Life‐Saving Medications Act, S. 296, 112th Cong., 2011.

6.“Executive order–reducing prescription drug shortages”. Office of the press secretary, The white house October 31st 2011

7. FDA schematic on drug production and distribution to prevent shortage. http://www.fda.gov/Drugs/DrugSafety/DrugShortages/ucm277626.htm

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