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Food and Drug Administration Issues Strategic Plan for Risk Communication
Gastroenterology and Hepatology News Richard Peek and K. Rajender Reddy, Section Editors
Study Shows How to Lower Costs, Waiting Times for Colonoscopies esearchers from North Carolina State University (NCSU), The Mayo Clinic, and the University of Massachusetts report the creation of a tool to help colonoscopy facilities operate more efficiently, decreasing the cost of the procedure and leading to shorter waiting times for patients. Their study, “A Discrete Event Simulation Model to Evaluate Operational Performance of a Colonoscopy Suit,” appeared in the September 22, 2009, on-line edition of Medical Decision Making. The authors used data from a computerized colonoscopy database to develop a discrete event simulation model of a colonoscopy suite. “This study’s aim is to evaluate resource allocation for optimal use of facilities for colonoscopy screening,” the authors write. Operational configurations were compared by varying the number of endoscopists, procedure rooms, patient arrival times, and procedure room turnaround time. Performance measures included the number of pa-
tients served during the clinic day and utilization of key resources. Further analysis included considering patient waiting time tradeoffs as well as the sensitivity of the system to procedure room turnaround time. The study found a linear relationship between the maximum number of patients served and the number of procedure rooms in the colonoscopy suite, with a fixed room to endoscopist ratio. “Utilization of intake and recovery resources becomes more efficient as the number of procedure rooms increases, indicating the potential benefits of large colonoscopy suites. Procedure room turnaround time has a significant influence on patient throughput, procedure room utilization, and endoscopist utilization for varying ratios between 1:1 and 2:1 rooms per endoscopist,” the authors state. “Finally, changes in the patient arrival schedule can reduce patient waiting time while not requiring a longer clinic day.” The report concludes that suite managers should keep a procedure room to endosco-
Food and Drug Administration Issues Strategic Plan for Risk Communication
about ways to minimize risk as they become increasingly involved in managing their health and well-being.” The plan defines 3 key areas— FDA’s scientific base, its operational capacity, and its policy and processes—in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies ⬎70 specific actions for the FDA to take over the next 5 years, including 14 that the agency commits to accomplishing over the next year. They include:
R
T
he US Food and Drug Administration (FDA) in September issued a strategic plan that outlines a framework for the agency to provide information about FDA-regulated products to health care professionals, patients and consumers in a usable and timely fashion, and which also describes how the agency oversees industry communications. “We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, MD. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers GASTROENTEROLOGY 2009;137:1866 –1868
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Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products.
pist ratio between 1:1 and 2:1 while considering the utilization of related key resources as a decision factor as well. The sensitivity of the system to processes such as turnaround time should be evaluated before improvement efforts are made.” “Colonoscopy facility managers can try out different ideas in the model to see how they work before trying them in the real world—which is an expensive place to experiment,” says Brian Denton, PhD, assistant professor of industrial and systems engineering at NCSU and co-author of the paper. “For example, a manager could see whether it is worthwhile to hire another endoscopist who can perform colonoscopies, hire another nurse, or buy another scope for their facility.” The researchers say they are now working with University of North Carolina Hospitals in Chapel Hill to implement the model, and ultimately hope to make it available for general use. See: Medical Decision Making, September 22, 2009, on-line. http://mdm. sagepub.com/cgi/rapidpdf/0272989X 09345890v1.
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Producing a research agenda for public dissemination.
●
Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research.
●
Developing an expert model to characterize tobacco-use related consumer decision making and better understand the likely impact of FDA oversight of tobacco products.
●
Developing a “library” of multimedia communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes.
●
Posting pictures of FDA-regulated products affected by class I or
Gastroenterology and Hepatology News continued
high-priority class II recalls as part of recall notices/information. ●
Developing detailed action plans at the agency and center levels for implementing and achieving the
Study Outlines Strategies to Test New Payment Models for Health Care
N
ew research outlines methods that might be used to test a novel payment system for medical care that would provide doctors, hospitals and other health providers a set fee for treatments. Proposals to pay health providers for so-called “episodes of care” have gained momentum during the ongoing debate about national health care reform as a strategy that could both curb medical spending and improve the quality of care. Although payments based on episodes of care have been widely discussed, the approach is largely conceptual with little realworld experience that might help to guide the design or adoption of the strategy, according to the study published in the September/October issue of the journal Health Affairs. Researchers from RAND Health analyzed claims information from a large group of Medicare beneficiaries and identified key issues that should be considered to help determine how to define episodes of care and identify which provider is accountable for an episode. “While using episodes of care as the basis for payment has enormous potential, we found there are many unanswered questions that must be addressed before moving forward,” said Peter Hussey, the
According to the FDA, the plan “reflects the agency’s belief that risk
communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness.” See: http://www.fda.gov “FDA’s Strategic Plan for Risk Communication.”
study’s lead author and a policy researcher at RAND, the nonprofit research organization. “We’ve identified steps that should be taken to help move from concept to implementation.” Critics of the current payment system for health care say it encourages overuse of services because physicians and others are paid separately for each procedure or test performed. Under an episode of care approach, some or all of the services related to the management of a patient’s chronic or acute medical condition would be grouped together and paid for in a lump sum. For example, public or private insurance programs might make a single payment for all physician, facility, and pharmacy services related to care for conditions such as implanting an artificial hip or managing a patient’s diabetes. Supporters of the strategy say it would shift the financial incentives in a way that would encourage providers to eliminate unnecessary procedures and tests, as well as promoting the best quality care to help patients stay healthy or recover quickly. The RAND study highlights some of the challenges that must be overcome in designing a program to test the utility of paying for medical care based on episodes of care. Among those challenges is defining what provider is responsible for managing
treatment for different conditions, a complicated task because patients frequently are treated by a wide variety of providers and in numerous settings for many different problems. For example, the researchers found that in more than half of the hip fractures they examined among Medicare beneficiaries, patients were treated in ⱖ4 different settings. For some conditions, including diabetes and low back pain, most patients were treated in just 1 setting. In addition, many of the patients studied had multiple chronic conditions such as high blood pressure and elevated cholesterol levels. Encouraging a single-condition focus through an episode-based payment plan may not be optimal for these patients, according to the study. The researchers outlined several applied studies they say would facilitate more rapid movement of episode-based payment approaches from concept to implementation beyond the approaches used in the current pilot studies. “Among the issues studies must address are how to define an episode of care; understanding the sources of variation within episodes of care; and whether some types of providers would be put at undue financial risk if their patients were treated under an episode of care scheme,” the report states. See: Health Affairs 2009;28:1406 –1417.
proposed action steps, including timelines, responsibilities, and resource needs.
1867
Study Shows How to Lower Costs, Waiting Times for Colonoscopies esearchers from North Carolina State University (NCSU), The Mayo Clinic, and the University of Massachusetts report the creation of a tool to help colonoscopy facilities operate more efficiently, decreasing the cost of the procedure and leading to shorter waiting times for patients. Their study, “A Discrete Event Simulation Model to Evaluate Operational Performance of a Colonoscopy Suit,” appeared in the September 22, 2009, on-line edition of Medical Decision Making. The authors used data from a computerized colonoscopy database to develop a discrete event simulation model of a colonoscopy suite. “This study’s aim is to evaluate resource allocation for optimal use of facilities for colonoscopy screening,” the authors write. Operational configurations were compared by varying the number of endoscopists, procedure rooms, patient arrival times, and procedure room turnaround time. Performance measures included the number of pa-
tients served during the clinic day and utilization of key resources. Further analysis included considering patient waiting time tradeoffs as well as the sensitivity of the system to procedure room turnaround time. The study found a linear relationship between the maximum number of patients served and the number of procedure rooms in the colonoscopy suite, with a fixed room to endoscopist ratio. “Utilization of intake and recovery resources becomes more efficient as the number of procedure rooms increases, indicating the potential benefits of large colonoscopy suites. Procedure room turnaround time has a significant influence on patient throughput, procedure room utilization, and endoscopist utilization for varying ratios between 1:1 and 2:1 rooms per endoscopist,” the authors state. “Finally, changes in the patient arrival schedule can reduce patient waiting time while not requiring a longer clinic day.” The report concludes that suite managers should keep a procedure room to endosco-
Food and Drug Administration Issues Strategic Plan for Risk Communication
about ways to minimize risk as they become increasingly involved in managing their health and well-being.” The plan defines 3 key areas— FDA’s scientific base, its operational capacity, and its policy and processes—in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies ⬎70 specific actions for the FDA to take over the next 5 years, including 14 that the agency commits to accomplishing over the next year. They include:
R
T
he US Food and Drug Administration (FDA) in September issued a strategic plan that outlines a framework for the agency to provide information about FDA-regulated products to health care professionals, patients and consumers in a usable and timely fashion, and which also describes how the agency oversees industry communications. “We are committed to improving communications the public receives about the products we regulate,” said Commissioner of Food and Drugs Margaret A. Hamburg, MD. “The FDA must communicate frequently and clearly about risks and benefits and inform patients and consumers GASTROENTEROLOGY 2009;137:1866 –1868
●
Designing a series of surveys to assess the public’s understanding of, and satisfaction with, FDA communications about medical products.
pist ratio between 1:1 and 2:1 while considering the utilization of related key resources as a decision factor as well. The sensitivity of the system to processes such as turnaround time should be evaluated before improvement efforts are made.” “Colonoscopy facility managers can try out different ideas in the model to see how they work before trying them in the real world—which is an expensive place to experiment,” says Brian Denton, PhD, assistant professor of industrial and systems engineering at NCSU and co-author of the paper. “For example, a manager could see whether it is worthwhile to hire another endoscopist who can perform colonoscopies, hire another nurse, or buy another scope for their facility.” The researchers say they are now working with University of North Carolina Hospitals in Chapel Hill to implement the model, and ultimately hope to make it available for general use. See: Medical Decision Making, September 22, 2009, on-line. http://mdm. sagepub.com/cgi/rapidpdf/0272989X 09345890v1.
●
Producing a research agenda for public dissemination.
●
Creating and maintaining a useful, easily accessible internal database of FDA and other relevant risk communication research.
●
Developing an expert model to characterize tobacco-use related consumer decision making and better understand the likely impact of FDA oversight of tobacco products.
●
Developing a “library” of multimedia communications on safe food practices for general education purposes and for use with crisis communications concerning food contamination episodes.
●
Posting pictures of FDA-regulated products affected by class I or
Gastroenterology and Hepatology News continued
high-priority class II recalls as part of recall notices/information. ●
Developing detailed action plans at the agency and center levels for implementing and achieving the
Study Outlines Strategies to Test New Payment Models for Health Care
N
ew research outlines methods that might be used to test a novel payment system for medical care that would provide doctors, hospitals and other health providers a set fee for treatments. Proposals to pay health providers for so-called “episodes of care” have gained momentum during the ongoing debate about national health care reform as a strategy that could both curb medical spending and improve the quality of care. Although payments based on episodes of care have been widely discussed, the approach is largely conceptual with little realworld experience that might help to guide the design or adoption of the strategy, according to the study published in the September/October issue of the journal Health Affairs. Researchers from RAND Health analyzed claims information from a large group of Medicare beneficiaries and identified key issues that should be considered to help determine how to define episodes of care and identify which provider is accountable for an episode. “While using episodes of care as the basis for payment has enormous potential, we found there are many unanswered questions that must be addressed before moving forward,” said Peter Hussey, the
According to the FDA, the plan “reflects the agency’s belief that risk
communications must be adapted to the needs of different audiences and should be evaluated to ensure effectiveness.” See: http://www.fda.gov “FDA’s Strategic Plan for Risk Communication.”
study’s lead author and a policy researcher at RAND, the nonprofit research organization. “We’ve identified steps that should be taken to help move from concept to implementation.” Critics of the current payment system for health care say it encourages overuse of services because physicians and others are paid separately for each procedure or test performed. Under an episode of care approach, some or all of the services related to the management of a patient’s chronic or acute medical condition would be grouped together and paid for in a lump sum. For example, public or private insurance programs might make a single payment for all physician, facility, and pharmacy services related to care for conditions such as implanting an artificial hip or managing a patient’s diabetes. Supporters of the strategy say it would shift the financial incentives in a way that would encourage providers to eliminate unnecessary procedures and tests, as well as promoting the best quality care to help patients stay healthy or recover quickly. The RAND study highlights some of the challenges that must be overcome in designing a program to test the utility of paying for medical care based on episodes of care. Among those challenges is defining what provider is responsible for managing
treatment for different conditions, a complicated task because patients frequently are treated by a wide variety of providers and in numerous settings for many different problems. For example, the researchers found that in more than half of the hip fractures they examined among Medicare beneficiaries, patients were treated in ⱖ4 different settings. For some conditions, including diabetes and low back pain, most patients were treated in just 1 setting. In addition, many of the patients studied had multiple chronic conditions such as high blood pressure and elevated cholesterol levels. Encouraging a single-condition focus through an episode-based payment plan may not be optimal for these patients, according to the study. The researchers outlined several applied studies they say would facilitate more rapid movement of episode-based payment approaches from concept to implementation beyond the approaches used in the current pilot studies. “Among the issues studies must address are how to define an episode of care; understanding the sources of variation within episodes of care; and whether some types of providers would be put at undue financial risk if their patients were treated under an episode of care scheme,” the report states. See: Health Affairs 2009;28:1406 –1417.
proposed action steps, including timelines, responsibilities, and resource needs.
1867