The Institute of Medicine has just published a report entitled, Initial National Priorities for Comparative Effectiveness Research, which lists many high to low priority comparative research areas to be investigated. Their proposed objective was stated as:
"CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels."
The purpose is an interesting one. It assists consumers first, then clinicians and then purchasers, one assumes the Government, and then policy makers. The intent is to improve health care whatever they mean by that. One hopes that they did not want to destroy health care. But some much for the staff member who wrote this.
We now look at a few here briefly:
First in their first tier of studies they include;
Compare the effectiveness of treatment strategies for atrial fibrillation including surgery, catheter ablation, and pharmacologic treatment.
There are many arguments which can be had here for in some cases ablation works and in others one may ablate the wrong location. Typically it is a set of customized treatments fine tuned to fit the patient. Here they are most likely trying to reduce the surgery load and its co-morbidity.
Compare the effectiveness of upper endoscopy utilization and frequency for patients with gastroesophageal reflux disease on morbidity, quality of life, and diagnosis of esophageal adenocarcinoma.
This is an interesting study because we know that a Barrett's esophagitis is often a precursor to esophageal cancer. Upper endoscopy is a gold standard to use but there is a concern for overuse. The issue is when and how long to wait. With mild gastric reflux should there be an upper GI scoping, just to be certain, and many times it may be junctional as well. The question they pose is one of cost effectiveness, for scoping everyone would clearly reduce mortality but at what cost? That is what Medicare and the current Administration want to control.
Compare the effectiveness of genetic and biomarker testing and usual care in preventing and treating breast, colorectal, prostate, lung, and ovarian cancer, and possibly other clinical conditions for which promising biomarkers exist.
This we have been arguing for on an ongoing basis. However as we has written we see this as a continually evolving area and one with great changes as well. Thus why CER for this? The results willl be unstable at best.
Compare the effectiveness of management strategies for localized prostate cancer (e.g., active surveillance, radical prostatectomy [conventional, robotic, and laparoscopic], radiotherapy [conformal, brachytherapy, proton-beam, and intensity-modulated radiotherapy]) on survival, recurrence, side effects, quality of life, and costs.
This is a really problematic issue. Here we have the catch phrase of quality which we have already had a discussion on. Every time I see another prostate carcinoma I can see multiple options presented. Some patients want to retain sexual capability at all costs, thus ruling out surgery, and others want to reduce the chance of any bowel malfunction thus ruling out seed implants. The problem here is I believe a genetic staging issue to begin with. Not all prostate cancers are the same, there are that 5-10% which are excessively aggressive and we would want to deal with them accordingly. A robotic approach makes up for a mediocre surgeon but it is also a good marketing tool. This again is a personal decision which the CER approach wants to generalize. I believe that it will be difficult to do.
Finally one of the class 4 CER proposals is:
Compare the effectiveness of different long-term treatments for acne.
This I really like, it brings me back fifty five years! It is good to see our money being well spent. The solution is just grow up in some cases. Indeed there are those few acne cases which are disfiguring, but they still present as a clinical challenge.
The NEJM article by Iglehart states:
" The ARRA, which is the $787 billion economic stimulus package that President Barack Obama signed into law on February 17, 2009, included $1.1 billion for CER. The research priorities developed by the IOM committee — delivered as Congress requested only 19 weeks after Obama signed the measure — must be taken into account by the DHHS as it allocates $400 million in support of CER projects over the next 2 years."
Thus what happens here is the stimulus is passed and the fuse is running and this longs fishing list is prepared and funding distributed. It is likely that much of what is here will be wasted. This is the problem with this type of Government, just spend money, and watch it wasted.
Iglehart continues:
"The IOM committee placed particular emphasis on leading questions regarding the clinical effectiveness of care. Half the 100 recommended primary research areas compare some aspect of the health care delivery system .... Explaining this emphasis, the report says: “Research topics categorized in this group focus on comparing how or where services are provided, rather than which services are provided. The prominence of health care delivery systems in the portfolio primarily reflects the interest of the public . . . as well as the committee’s belief that an early investment in CER should focus on learning how to make services more effective
Nearly a third of the other primary research priorities address racial and ethnic disparities, and nearly a fifth address patients’ functional limitations and disabilities. Other key priority areas are cardiovascular disease, geriatrics, psychiatric disorders, neurologic disorders, and pediatrics."
The focus on many issues was on how care is provided and what makes for better care. In a manner these are process questions rather than true clinical questions.
In another NEJM paper by Conway and Clancy the authors state:
"The Council’s vision is to lay the foundation and build the infrastructure for CER to develop
and prosper so it can inform decisions made by patients and clinicians. The Council specifically
identified high-priority research gaps and one-time investments in infrastructure that would accelerate the conduct of CER by multiple researchers. We set three main objectives: to develop a definition, establish prioritization criteria, create a strategic framework, and identify priorities for CER; to foster optimal coordination of CER conducted or supported by federal departments; and to formulate recommendations for investing the $400 million provided to the Office of the Secretary.
To establish a transparent, collaborative process for making recommendations, the Council sought public input through three public listening sessions and extensive commenting on its public Web site. The Council heard from hundreds of diverse stakeholders and received feedback on draft documents.
We defined CER as the conduct and synthesis of research comparing the benefits and harms
of various interventions and strategies for preventing, diagnosing, treating, and monitoring health conditions in real-world settings.
The purpose of this research is to improve health outcomes by developing and disseminating evidence based information to patients, clinicians, and other decision makers about which interventions are most effective for which patients under specific circumstances."
Unfortunately there is a rush here to satisfy the Government mandate and I fear that many well posed questions will be thrown under the trucks of the Government need to spend rather than the true need to think and act accordingly.
"CER is the generation and synthesis of evidence that compares the benefits and harms of alternative methods to prevent, diagnose, treat, and monitor a clinical condition or to improve the delivery of care. The purpose of CER is to assist consumers, clinicians, purchasers, and policy makers to make informed decisions that will improve health care at both the individual and population levels."
The purpose is an interesting one. It assists consumers first, then clinicians and then purchasers, one assumes the Government, and then policy makers. The intent is to improve health care whatever they mean by that. One hopes that they did not want to destroy health care. But some much for the staff member who wrote this.
We now look at a few here briefly:
First in their first tier of studies they include;
Compare the effectiveness of treatment strategies for atrial fibrillation including surgery, catheter ablation, and pharmacologic treatment.
There are many arguments which can be had here for in some cases ablation works and in others one may ablate the wrong location. Typically it is a set of customized treatments fine tuned to fit the patient. Here they are most likely trying to reduce the surgery load and its co-morbidity.
Compare the effectiveness of upper endoscopy utilization and frequency for patients with gastroesophageal reflux disease on morbidity, quality of life, and diagnosis of esophageal adenocarcinoma.
This is an interesting study because we know that a Barrett's esophagitis is often a precursor to esophageal cancer. Upper endoscopy is a gold standard to use but there is a concern for overuse. The issue is when and how long to wait. With mild gastric reflux should there be an upper GI scoping, just to be certain, and many times it may be junctional as well. The question they pose is one of cost effectiveness, for scoping everyone would clearly reduce mortality but at what cost? That is what Medicare and the current Administration want to control.
Compare the effectiveness of genetic and biomarker testing and usual care in preventing and treating breast, colorectal, prostate, lung, and ovarian cancer, and possibly other clinical conditions for which promising biomarkers exist.
This we have been arguing for on an ongoing basis. However as we has written we see this as a continually evolving area and one with great changes as well. Thus why CER for this? The results willl be unstable at best.
Compare the effectiveness of management strategies for localized prostate cancer (e.g., active surveillance, radical prostatectomy [conventional, robotic, and laparoscopic], radiotherapy [conformal, brachytherapy, proton-beam, and intensity-modulated radiotherapy]) on survival, recurrence, side effects, quality of life, and costs.
This is a really problematic issue. Here we have the catch phrase of quality which we have already had a discussion on. Every time I see another prostate carcinoma I can see multiple options presented. Some patients want to retain sexual capability at all costs, thus ruling out surgery, and others want to reduce the chance of any bowel malfunction thus ruling out seed implants. The problem here is I believe a genetic staging issue to begin with. Not all prostate cancers are the same, there are that 5-10% which are excessively aggressive and we would want to deal with them accordingly. A robotic approach makes up for a mediocre surgeon but it is also a good marketing tool. This again is a personal decision which the CER approach wants to generalize. I believe that it will be difficult to do.
Finally one of the class 4 CER proposals is:
Compare the effectiveness of different long-term treatments for acne.
This I really like, it brings me back fifty five years! It is good to see our money being well spent. The solution is just grow up in some cases. Indeed there are those few acne cases which are disfiguring, but they still present as a clinical challenge.
The NEJM article by Iglehart states:
" The ARRA, which is the $787 billion economic stimulus package that President Barack Obama signed into law on February 17, 2009, included $1.1 billion for CER. The research priorities developed by the IOM committee — delivered as Congress requested only 19 weeks after Obama signed the measure — must be taken into account by the DHHS as it allocates $400 million in support of CER projects over the next 2 years."
Thus what happens here is the stimulus is passed and the fuse is running and this longs fishing list is prepared and funding distributed. It is likely that much of what is here will be wasted. This is the problem with this type of Government, just spend money, and watch it wasted.
Iglehart continues:
"The IOM committee placed particular emphasis on leading questions regarding the clinical effectiveness of care. Half the 100 recommended primary research areas compare some aspect of the health care delivery system .... Explaining this emphasis, the report says: “Research topics categorized in this group focus on comparing how or where services are provided, rather than which services are provided. The prominence of health care delivery systems in the portfolio primarily reflects the interest of the public . . . as well as the committee’s belief that an early investment in CER should focus on learning how to make services more effective
Nearly a third of the other primary research priorities address racial and ethnic disparities, and nearly a fifth address patients’ functional limitations and disabilities. Other key priority areas are cardiovascular disease, geriatrics, psychiatric disorders, neurologic disorders, and pediatrics."
The focus on many issues was on how care is provided and what makes for better care. In a manner these are process questions rather than true clinical questions.
In another NEJM paper by Conway and Clancy the authors state:
"The Council’s vision is to lay the foundation and build the infrastructure for CER to develop
and prosper so it can inform decisions made by patients and clinicians. The Council specifically
identified high-priority research gaps and one-time investments in infrastructure that would accelerate the conduct of CER by multiple researchers. We set three main objectives: to develop a definition, establish prioritization criteria, create a strategic framework, and identify priorities for CER; to foster optimal coordination of CER conducted or supported by federal departments; and to formulate recommendations for investing the $400 million provided to the Office of the Secretary.
To establish a transparent, collaborative process for making recommendations, the Council sought public input through three public listening sessions and extensive commenting on its public Web site. The Council heard from hundreds of diverse stakeholders and received feedback on draft documents.
We defined CER as the conduct and synthesis of research comparing the benefits and harms
of various interventions and strategies for preventing, diagnosing, treating, and monitoring health conditions in real-world settings.
The purpose of this research is to improve health outcomes by developing and disseminating evidence based information to patients, clinicians, and other decision makers about which interventions are most effective for which patients under specific circumstances."
Unfortunately there is a rush here to satisfy the Government mandate and I fear that many well posed questions will be thrown under the trucks of the Government need to spend rather than the true need to think and act accordingly.
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