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From Research to Health Care Practice

From Research to Health Care Practice As the US government works to implement health care reform, it has committed more than $1.1 billion to funding comparative effectiveness research that may help guide decision making. In doing so, the United States has joined other nations that are looking toward comparative effectiveness data as a means to improve health care quality. Several other countries have already established systems to develop comparative effectiveness data, assess that data, and translate it into policy. Since 1999, the National Institute for Health and Clinical Excellence (NICE) has been fulfilling this role in the United Kingdom. Kalipso Chalkidou, MD, PhD, director of NICE's international program, spoke with JAMA recently about how the National Health Service (NHS) in England and Wales uses comparative effectiveness data. (Photo credit: Duncan Rand) Kalipso Chalkidou, MD, PhD, director of the international program at the United Kingdom's National Institute for Health and Clinical Excellence (NICE). NICE assesses comparative effectiveness data to guide policy making. JAMA:Why was NICE created? Dr Chalkidou: The idea was to try to address inappropriate variation in the type and quality of health services people were receiving, which was a big problem back then and still is, though things have improved. The second goal was to improve the uptake of new technologies [by instructing the NHS to pay for them]. In fact, we do have the data to show we have done exactly that in many areas. Additional reasons for the creation of NICE were improving quality of care, making sure guidelines were available for professionals across the board, and ensuring that any additional money going into the health service is used efficiently. JAMA:How does NICE fulfill this mission to improve care and efficiency? Dr Chalkidou: We use local and international evidence and the local cultural values of England and Wales as inputs into a process that is transparent, consultative, and independent from interference from central government, hospitals, patients, clinicians, the pharmaceutical industry, or the health care industry in general. The output is actionable policy and practice recommendations. The idea is to translate evidence into policies. JAMA:How are topics selected for evaluation, and how are they evaluated? Dr Chalkidou: We have different sources of potential topics. We have a horizon scanning center, based at a university and funded by the department of health, that looks at pharmaceutical company pipelines to identify what we should be looking at. We have a Web site where basically anybody can suggest a topic. We have a network of consultants who work regionally with clinicians, administrators, and patients, and we get a lot of suggestions from them. There's a process for NICE staff to suggest topics. There are also policy priorities indicated by our government. All of these things get fed through to topic selection panels manned mostly by clinicians, though there are other stakeholders—industry representatives, patient representatives, academics, epidemiologists, and economists. They have a set of criteria and a process for identifying the key priorities. The minister of the department of health approves the selected topics. JAMA:How are NICE guidelines developed? Who is involved? Dr Chalkidou: Before NICE was established, the royal colleges and the professional associations were responsible for developing guidelines. The government would give money to the organizations to develop guidelines. But this was perceived to be problematic. Every group had its own priorities. There was a lack of consistency in the process of developing the guidelines, reflected in different formats, different ways of appraising the evidence, and different ways of engaging with people. A lot of the time there was very little public engagement. There was also a perception that these guidelines might not be that independent. Now the government directs funds through NICE to the professional organizations. NICE takes the role of a quality assurer. We set out how the guidelines will be developed and for what problems. We set requirements—for instance, on how many patients to involve and how to involve them. Every guideline that comes out has the stamp of the professional association or college and NICE. JAMA:How are cost considerations figured into NICE recommendations? Dr Chalkidou: There is a lot of science on how economic analysis can inform decision making. The first hurdle is clinical effectiveness—the technology or service has to be demonstrated to work. After that, given the likelihood it could work and the margins of the clinical benefit, is it worth the extra cost? It's not an exact science. It's not as if there is a figure that comes out of the model and the decision is made automatically. Our committees have a lot of flexibility. One of our first appraisals considered a drug for flu-like symptoms in otherwise healthy adults. The drug seemed to work and was relatively inexpensive, about £5 [approximately $7.62] per day for 5 days. However, the magnitude of the clinical benefit was a reduction in symptoms by half a day, 2 days instead of 2.5. So the committee felt it was not clinically worth the overall cost and the increased number of visits to family physicians. Some things are approved even though they are a lot less cost-effective than what we tend to approve. For example, we looked at a drug for a malignancy of the lungs caused by asbestos exposure in miners and shipyard workers. At the time these people were working, nobody knew this was a cause of cancer. It's a difficult disease. This drug is not curative, but it extends life by 2 to 3 months. Even though it was not cost-effective, the committee felt it was something worth paying for. JAMA:Has NICE reduced health care costs in England and Wales? Dr Chalkidou: NICE published its first guidance in 2002, the year that the government announced the biggest funding boost for the NHS in its history. There was a 50% real increase in NHS funding, about an extra £100 billion (approximately $156 billion), between 2002 and 2009. So, the first 10 years of NICE have been years of investment in the NHS, and we’ve been asked to come up with good investments. The coming decade will be years where we have to help the system make efficiency savings because the money is running out and we won't be able to continue the funding increases. They will be testing times for NICE and the health system to try to identify, in an evidence-based way, things that we shouldn't be doing, and things we should be doing more efficiently. JAMA:What is the process for appealing a decision by NICE? Dr Chalkidou: People can be involved throughout the process, from selecting the topic all the way to publishing the final recommendation. Appeal is the final step, if somebody disagrees. We get appeals from manufacturers that feel their products ought to have been covered and from patients and professional organizations that think a drug should be made available. We get an increasing number of appeals from local public insurers, who basically feel something is unaffordable and doesn't offer as much value as alternatives for their populations in their areas. The appeal process gives us an opportunity to address their concerns and to revisit the guidance. The appeals are heard by an independent committee led by the chair of NICE, who is not involved in the guidance development process itself. We also have representatives of NHS, industry, clinicians, and other representatives of NICE on the committee. About half of NICE's decisions on technologies are appealed. Decisions can and do change, and in about 1 in 3 cases the appeals are upheld, at least partly. If the appeal is upheld, the committee [that came to the original decision] is asked to have another look. The change the committee makes could be minor—rewriting to make sure people understand what they are saying—or substantive. For example, if the committee looks at another piece of evidence that it hadn't realized was there, the actual decision could change. If an appeal is upheld, it can delay publication of the guidance about 2 months, but it is important and fair to allow people to raise their concerns. JAMA:What would you say are the key elements of a successful comparative effectiveness program? Dr Chalkidou: It is context-specific. Something that is important to success in the United States might not work in England or Japan. I think our model has some good aspects to it. The principle of independence is very important. It is also really important to be responsive, to show people how you do what you do, what type of evidence you consider, how you evaluate the evidence, and how you reach the final decision. Engagement is really important. It is important to be scientific in your methods, the way you evaluate the evidence and the way you do the economic evaluation. If you lose your science, you lose your credibility. JAMA:Are their any lessons to be learned from NICE's experience? Dr Chalkidou: Allowing policy makers to have a say is hugely important. We talk about evidence-based policy making, but setting the priorities for research is undertaken by a different group of people. To close the loop, we need to make sure policy makers have a say to make sure research is policy relevant. JAMA:Do you think the experience at NICE has implications for the United States as we begin to promote more comparative effectiveness research? Dr Chalkidou: One thing worth thinking about in the United States is whether you will take the step from research to policy. It's not clear whether it will happen. It would have to happen in a unique and America-specific way, but it will have to happen. Otherwise you send all the money to research, but don't have the mechanisms for translating and implementing this research into practice. It's one thing to disseminate and make things available, but to get people to use these things is a different story. JAMA:Are there other considerations unique to the United States? Dr Chalkidou: Some general principles should be applicable; how you implement them would be different. We have a pay-for-performance scheme for general practitioners. About 20% of the salaries of primary care practitioners can be made up of rewards for doing things that are evidence-based. NICE is now responsible for setting metrics for measuring clinicians' performance. I’m not sure you could have such a framework across the United States. You have different insurers, sometimes paying for care for very different population groups. There are differences, but the principle of using evidence and values to inform and reward good practice, or not reward bad practice, is the same. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png JAMA American Medical Association

From Research to Health Care Practice

Kuehn, Bridget M.
JAMA , Volume 304 (10) – Sep 8, 2010
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Publisher
American Medical Association
Copyright
Copyright © 2010 American Medical Association. All Rights Reserved.
ISSN
0098-7484
eISSN
1538-3598
DOI
10.1001/jama.2010.1289
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Abstract

As the US government works to implement health care reform, it has committed more than $1.1 billion to funding comparative effectiveness research that may help guide decision making. In doing so, the United States has joined other nations that are looking toward comparative effectiveness data as a means to improve health care quality. Several other countries have already established systems to develop comparative effectiveness data, assess that data, and translate it into policy. Since 1999, the National Institute for Health and Clinical Excellence (NICE) has been fulfilling this role in the United Kingdom. Kalipso Chalkidou, MD, PhD, director of NICE's international program, spoke with JAMA recently about how the National Health Service (NHS) in England and Wales uses comparative effectiveness data. (Photo credit: Duncan Rand) Kalipso Chalkidou, MD, PhD, director of the international program at the United Kingdom's National Institute for Health and Clinical Excellence (NICE). NICE assesses comparative effectiveness data to guide policy making. JAMA:Why was NICE created? Dr Chalkidou: The idea was to try to address inappropriate variation in the type and quality of health services people were receiving, which was a big problem back then and still is, though things have improved. The second goal was to improve the uptake of new technologies [by instructing the NHS to pay for them]. In fact, we do have the data to show we have done exactly that in many areas. Additional reasons for the creation of NICE were improving quality of care, making sure guidelines were available for professionals across the board, and ensuring that any additional money going into the health service is used efficiently. JAMA:How does NICE fulfill this mission to improve care and efficiency? Dr Chalkidou: We use local and international evidence and the local cultural values of England and Wales as inputs into a process that is transparent, consultative, and independent from interference from central government, hospitals, patients, clinicians, the pharmaceutical industry, or the health care industry in general. The output is actionable policy and practice recommendations. The idea is to translate evidence into policies. JAMA:How are topics selected for evaluation, and how are they evaluated? Dr Chalkidou: We have different sources of potential topics. We have a horizon scanning center, based at a university and funded by the department of health, that looks at pharmaceutical company pipelines to identify what we should be looking at. We have a Web site where basically anybody can suggest a topic. We have a network of consultants who work regionally with clinicians, administrators, and patients, and we get a lot of suggestions from them. There's a process for NICE staff to suggest topics. There are also policy priorities indicated by our government. All of these things get fed through to topic selection panels manned mostly by clinicians, though there are other stakeholders—industry representatives, patient representatives, academics, epidemiologists, and economists. They have a set of criteria and a process for identifying the key priorities. The minister of the department of health approves the selected topics. JAMA:How are NICE guidelines developed? Who is involved? Dr Chalkidou: Before NICE was established, the royal colleges and the professional associations were responsible for developing guidelines. The government would give money to the organizations to develop guidelines. But this was perceived to be problematic. Every group had its own priorities. There was a lack of consistency in the process of developing the guidelines, reflected in different formats, different ways of appraising the evidence, and different ways of engaging with people. A lot of the time there was very little public engagement. There was also a perception that these guidelines might not be that independent. Now the government directs funds through NICE to the professional organizations. NICE takes the role of a quality assurer. We set out how the guidelines will be developed and for what problems. We set requirements—for instance, on how many patients to involve and how to involve them. Every guideline that comes out has the stamp of the professional association or college and NICE. JAMA:How are cost considerations figured into NICE recommendations? Dr Chalkidou: There is a lot of science on how economic analysis can inform decision making. The first hurdle is clinical effectiveness—the technology or service has to be demonstrated to work. After that, given the likelihood it could work and the margins of the clinical benefit, is it worth the extra cost? It's not an exact science. It's not as if there is a figure that comes out of the model and the decision is made automatically. Our committees have a lot of flexibility. One of our first appraisals considered a drug for flu-like symptoms in otherwise healthy adults. The drug seemed to work and was relatively inexpensive, about £5 [approximately $7.62] per day for 5 days. However, the magnitude of the clinical benefit was a reduction in symptoms by half a day, 2 days instead of 2.5. So the committee felt it was not clinically worth the overall cost and the increased number of visits to family physicians. Some things are approved even though they are a lot less cost-effective than what we tend to approve. For example, we looked at a drug for a malignancy of the lungs caused by asbestos exposure in miners and shipyard workers. At the time these people were working, nobody knew this was a cause of cancer. It's a difficult disease. This drug is not curative, but it extends life by 2 to 3 months. Even though it was not cost-effective, the committee felt it was something worth paying for. JAMA:Has NICE reduced health care costs in England and Wales? Dr Chalkidou: NICE published its first guidance in 2002, the year that the government announced the biggest funding boost for the NHS in its history. There was a 50% real increase in NHS funding, about an extra £100 billion (approximately $156 billion), between 2002 and 2009. So, the first 10 years of NICE have been years of investment in the NHS, and we’ve been asked to come up with good investments. The coming decade will be years where we have to help the system make efficiency savings because the money is running out and we won't be able to continue the funding increases. They will be testing times for NICE and the health system to try to identify, in an evidence-based way, things that we shouldn't be doing, and things we should be doing more efficiently. JAMA:What is the process for appealing a decision by NICE? Dr Chalkidou: People can be involved throughout the process, from selecting the topic all the way to publishing the final recommendation. Appeal is the final step, if somebody disagrees. We get appeals from manufacturers that feel their products ought to have been covered and from patients and professional organizations that think a drug should be made available. We get an increasing number of appeals from local public insurers, who basically feel something is unaffordable and doesn't offer as much value as alternatives for their populations in their areas. The appeal process gives us an opportunity to address their concerns and to revisit the guidance. The appeals are heard by an independent committee led by the chair of NICE, who is not involved in the guidance development process itself. We also have representatives of NHS, industry, clinicians, and other representatives of NICE on the committee. About half of NICE's decisions on technologies are appealed. Decisions can and do change, and in about 1 in 3 cases the appeals are upheld, at least partly. If the appeal is upheld, the committee [that came to the original decision] is asked to have another look. The change the committee makes could be minor—rewriting to make sure people understand what they are saying—or substantive. For example, if the committee looks at another piece of evidence that it hadn't realized was there, the actual decision could change. If an appeal is upheld, it can delay publication of the guidance about 2 months, but it is important and fair to allow people to raise their concerns. JAMA:What would you say are the key elements of a successful comparative effectiveness program? Dr Chalkidou: It is context-specific. Something that is important to success in the United States might not work in England or Japan. I think our model has some good aspects to it. The principle of independence is very important. It is also really important to be responsive, to show people how you do what you do, what type of evidence you consider, how you evaluate the evidence, and how you reach the final decision. Engagement is really important. It is important to be scientific in your methods, the way you evaluate the evidence and the way you do the economic evaluation. If you lose your science, you lose your credibility. JAMA:Are their any lessons to be learned from NICE's experience? Dr Chalkidou: Allowing policy makers to have a say is hugely important. We talk about evidence-based policy making, but setting the priorities for research is undertaken by a different group of people. To close the loop, we need to make sure policy makers have a say to make sure research is policy relevant. JAMA:Do you think the experience at NICE has implications for the United States as we begin to promote more comparative effectiveness research? Dr Chalkidou: One thing worth thinking about in the United States is whether you will take the step from research to policy. It's not clear whether it will happen. It would have to happen in a unique and America-specific way, but it will have to happen. Otherwise you send all the money to research, but don't have the mechanisms for translating and implementing this research into practice. It's one thing to disseminate and make things available, but to get people to use these things is a different story. JAMA:Are there other considerations unique to the United States? Dr Chalkidou: Some general principles should be applicable; how you implement them would be different. We have a pay-for-performance scheme for general practitioners. About 20% of the salaries of primary care practitioners can be made up of rewards for doing things that are evidence-based. NICE is now responsible for setting metrics for measuring clinicians' performance. I’m not sure you could have such a framework across the United States. You have different insurers, sometimes paying for care for very different population groups. There are differences, but the principle of using evidence and values to inform and reward good practice, or not reward bad practice, is the same.

Journal

JAMA – American Medical Association

Published: Sep 8, 2010

Keywords: country of wales,guidelines,physicians, family,evidence-based practice,money,comparative effectiveness research,technology,reward,decision making,insurance carriers,policy making,cancer,influenza,asbestos exposure

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