Allen F. Shaughnessy, PharmD

The nonsteroidal anti-inflammatory drug (NSAID) class has become large enough to form 3 subgroups: aspirin, the traditional NSAIDs, and the cylooxygenase-2 (COX-2)–inhibiting NSAIDs. Although pharmacologically distinct, however, a clear advantage of the COX-2 inhibitors over the traditional NSAIDs remains to be demonstrated for typical short-term or long-term users of anti-inflammatory therapy.

Kivitz and colleagues¹ found that valdecoxib, a COX-2 inhibitor, produces similar pain relief to the older NSAID naproxen in the treatment of moderate to severe osteoarthritis of the knee. The effect on pain was dose related, with 20 mg daily producing results similar to those of naproxen at 500 mg twice daily.¹

When the researchers evaluated the safety of the 2 NSAIDs, the results were not as straightforward. The investigators performed endoscopy before the study and after 12 weeks of treatment. At 12 weeks, more ulcers were found on endoscopy in the naproxen group (10%) than in the 5- and 10-mg valdecoxib groups (3% incidence in each group, P ≤ .05). No difference was noted in the incidence of gastroduodenal ulcers between the naproxen and valdecoxib 20-mg groups. As in other studies of NSAIDs, most of these ulcers were asymptomatic. Ulcers caused by NSAIDs frequently are transient, and gastric symptoms correlate poorly with the presence of these ulcers.² Further, the Food and Drug Administration does not consider endoscopically proven ulcers to be a surrogate for clinically relevant events.³

The much more important safety outcome for NSAIDs is the incidence of POBs: perforation, gastric outlet obstruction, or gastric bleeding. These adverse effects may result in hospitalization and death. Fortunately for patients, these effects occur rarely, even in the worst offenders in the NSAID class.

Such is the case with another COX-2 inhibitor, celecoxib. Although data after 6 months of therapy showed a lower incidence of POBs as compared with ibuprofen or diclofenac,⁴ unpublished data for the second 6 months of treatment showed, overall, similar rates among the 3 drugs.⁵ Dropouts due to adverse effects were also similar in the ibuprofen- and celecoxib-treated patients.

Rofecoxib, another COX-2 inhibitor, produced a slightly lower rate of POBs than did other NSAIDs (1.3% vs 1.8%).⁶ Given these statistics, 1 POB would be prevented for every 200 patients given rofecoxib rather than a traditional NSAID for a full year.

The study by Kivitz et al does not give us much guidance with regard to the role valdecoxib or, by implication, other COX-2 inhibitors should play in clinical care. At equivalent doses, all of the COX-2 inhibitors seemed to produce analgesia and inflammation reduction similar to that of the older NSAIDs. Current research, however, does not support a safety or tolerability advantage of this class of drugs for most patients over the nonspecific NSAIDs that have been around since the 1960s. Even if there is a small advantage of COX-2 inhibitors with regard to POBs, this advantage would be realized only in patients at high risk of complications who will be taking the drug for many months—the only group for whom COX-2 inhibitors should be considered a drug of choice. Although definitive work has not been done to identify high-risk groups, it may be reasonable to include patients for whom a bleeding complication would be devastating, such as the frail elderly and patients with a history of significant gastrointestinal bleeding.

The nonsteroidal anti-inflammatory drug (NSAID) class has become large enough to form 3 subgroups: aspirin, the traditional NSAIDs, and the cylooxygenase-2 (COX-2)–inhibiting NSAIDs. Although pharmacologically distinct, however, a clear advantage of the COX-2 inhibitors over the traditional NSAIDs remains to be demonstrated for typical short-term or long-term users of anti-inflammatory therapy.

Kivitz and colleagues¹ found that valdecoxib, a COX-2 inhibitor, produces similar pain relief to the older NSAID naproxen in the treatment of moderate to severe osteoarthritis of the knee. The effect on pain was dose related, with 20 mg daily producing results similar to those of naproxen at 500 mg twice daily.¹

When the researchers evaluated the safety of the 2 NSAIDs, the results were not as straightforward. The investigators performed endoscopy before the study and after 12 weeks of treatment. At 12 weeks, more ulcers were found on endoscopy in the naproxen group (10%) than in the 5- and 10-mg valdecoxib groups (3% incidence in each group, P ≤ .05). No difference was noted in the incidence of gastroduodenal ulcers between the naproxen and valdecoxib 20-mg groups. As in other studies of NSAIDs, most of these ulcers were asymptomatic. Ulcers caused by NSAIDs frequently are transient, and gastric symptoms correlate poorly with the presence of these ulcers.² Further, the Food and Drug Administration does not consider endoscopically proven ulcers to be a surrogate for clinically relevant events.³

The much more important safety outcome for NSAIDs is the incidence of POBs: perforation, gastric outlet obstruction, or gastric bleeding. These adverse effects may result in hospitalization and death. Fortunately for patients, these effects occur rarely, even in the worst offenders in the NSAID class.

Such is the case with another COX-2 inhibitor, celecoxib. Although data after 6 months of therapy showed a lower incidence of POBs as compared with ibuprofen or diclofenac,⁴ unpublished data for the second 6 months of treatment showed, overall, similar rates among the 3 drugs.⁵ Dropouts due to adverse effects were also similar in the ibuprofen- and celecoxib-treated patients.

Rofecoxib, another COX-2 inhibitor, produced a slightly lower rate of POBs than did other NSAIDs (1.3% vs 1.8%).⁶ Given these statistics, 1 POB would be prevented for every 200 patients given rofecoxib rather than a traditional NSAID for a full year.

The study by Kivitz et al does not give us much guidance with regard to the role valdecoxib or, by implication, other COX-2 inhibitors should play in clinical care. At equivalent doses, all of the COX-2 inhibitors seemed to produce analgesia and inflammation reduction similar to that of the older NSAIDs. Current research, however, does not support a safety or tolerability advantage of this class of drugs for most patients over the nonspecific NSAIDs that have been around since the 1960s. Even if there is a small advantage of COX-2 inhibitors with regard to POBs, this advantage would be realized only in patients at high risk of complications who will be taking the drug for many months—the only group for whom COX-2 inhibitors should be considered a drug of choice. Although definitive work has not been done to identify high-risk groups, it may be reasonable to include patients for whom a bleeding complication would be devastating, such as the frail elderly and patients with a history of significant gastrointestinal bleeding.

The nonsteroidal anti-inflammatory drug (NSAID) class has become large enough to form 3 subgroups: aspirin, the traditional NSAIDs, and the cylooxygenase-2 (COX-2)–inhibiting NSAIDs. Although pharmacologically distinct, however, a clear advantage of the COX-2 inhibitors over the traditional NSAIDs remains to be demonstrated for typical short-term or long-term users of anti-inflammatory therapy.

Kivitz and colleagues¹ found that valdecoxib, a COX-2 inhibitor, produces similar pain relief to the older NSAID naproxen in the treatment of moderate to severe osteoarthritis of the knee. The effect on pain was dose related, with 20 mg daily producing results similar to those of naproxen at 500 mg twice daily.¹

When the researchers evaluated the safety of the 2 NSAIDs, the results were not as straightforward. The investigators performed endoscopy before the study and after 12 weeks of treatment. At 12 weeks, more ulcers were found on endoscopy in the naproxen group (10%) than in the 5- and 10-mg valdecoxib groups (3% incidence in each group, P ≤ .05). No difference was noted in the incidence of gastroduodenal ulcers between the naproxen and valdecoxib 20-mg groups. As in other studies of NSAIDs, most of these ulcers were asymptomatic. Ulcers caused by NSAIDs frequently are transient, and gastric symptoms correlate poorly with the presence of these ulcers.² Further, the Food and Drug Administration does not consider endoscopically proven ulcers to be a surrogate for clinically relevant events.³

The much more important safety outcome for NSAIDs is the incidence of POBs: perforation, gastric outlet obstruction, or gastric bleeding. These adverse effects may result in hospitalization and death. Fortunately for patients, these effects occur rarely, even in the worst offenders in the NSAID class.

Such is the case with another COX-2 inhibitor, celecoxib. Although data after 6 months of therapy showed a lower incidence of POBs as compared with ibuprofen or diclofenac,⁴ unpublished data for the second 6 months of treatment showed, overall, similar rates among the 3 drugs.⁵ Dropouts due to adverse effects were also similar in the ibuprofen- and celecoxib-treated patients.

Rofecoxib, another COX-2 inhibitor, produced a slightly lower rate of POBs than did other NSAIDs (1.3% vs 1.8%).⁶ Given these statistics, 1 POB would be prevented for every 200 patients given rofecoxib rather than a traditional NSAID for a full year.

The study by Kivitz et al does not give us much guidance with regard to the role valdecoxib or, by implication, other COX-2 inhibitors should play in clinical care. At equivalent doses, all of the COX-2 inhibitors seemed to produce analgesia and inflammation reduction similar to that of the older NSAIDs. Current research, however, does not support a safety or tolerability advantage of this class of drugs for most patients over the nonspecific NSAIDs that have been around since the 1960s. Even if there is a small advantage of COX-2 inhibitors with regard to POBs, this advantage would be realized only in patients at high risk of complications who will be taking the drug for many months—the only group for whom COX-2 inhibitors should be considered a drug of choice. Although definitive work has not been done to identify high-risk groups, it may be reasonable to include patients for whom a bleeding complication would be devastating, such as the frail elderly and patients with a history of significant gastrointestinal bleeding.

It’s one thing to say that we have evidence that something works. It’s far more important to know how well it works. —David M. Eddy¹

In previous articles in this series on information mastery we outlined the importance of finding, evaluating, and implementing POEMs (Patient-Oriented Evidence that Matters) to maximize patient outcome at the point-of-care. Clinicians practicing as “information masters” will have the information they need when they need it, allowing them to offer their patients the best care.

In this article we take the concept of using POEMs one large and significant step further, and apply it not only to making decisions about individual patients, but also within the context of the entire community and population. Information mastery can improve the value of health delivery systems by increasing quality and controlling costs. By improving the value of health care, physicians should be able to provide universal and equitable health care access for all.

The problem of cost

Our collective complacency for 44 million uninsured is a national disgrace.²

The amount of money spent yearly in the United States for health care continues to rise at a rate faster than the rate of inflation. Whereas in 1960, when 5% of the gross national product was consumed by health care costs, this proportion has increased to 15% in the year 2000.³

Translating this number into actual dollars, the average family of 4 pays at least $10,000 per year in direct and indirect health care costs.⁴ Direct health care costs include insurance premiums and co-pays, and out-of-pocket expenses for medicines and devices. Additional, indirect, health care costs come in the form of higher costs of purchased goods as a result of the burden of paying for the health care of the workers who manufacture and sell the products.

More money is spent, per person, in the United States on health care than in any other country in the world. Approximately 50% more is spent on health care in the United States than is spent in Canada. The United Kingdom spends only about one-third of this amount of money.⁵ Despite this increased spending, average life expectancy is not substantially longer here than in other industrialized countries.^5,6

Socioeconomic status plays a larger role in the United States than health care spending in determining the length and quality of life.^7-12 In a recent study comparing survival rates for 15 “curable” cancers in Toronto, Ontario, and Detroit, Michigan, researchers found that socioeconomic status had no effect on survival for 12 of the 15 cancers occurring in the Canadians. However, patients who were in the lowest economic strata in Detroit had survival rates 40% lower than patients who had greater income did.⁹ Similar results have been found with heart disease,⁷ breast cancer,⁸ and HIV infection,¹¹ and for mortality rates in general across socioeconomic strata.¹³

It is a common assumption among many US lay persons and clinicians that the increase in mortality among the poor is due to an increase in high risk health behaviors, such as smoking, alcohol and drug abuse, obesity, and sedentary lifestyle. However, controlling for age, sex, race, urbanicity, education level, and health risk behaviors, people in the lowest-income group (family income $30,000 per year) have a mortality rate almost three-fold higher than those in the highest income group.¹⁴ This risk is especially high for low-income women, presumably because of inadequate prenatal care.

Despite an unemployment level that is at a 30-year low, more than 44 million people are uninsured, including 11 million children.¹⁵ The number of uninsured people grows at a rate of 100,000 people per month. These uninsured people are termed the “working poor”: persons who work in jobs with an income that makes them ineligible for public assistance programs but is insufficient to allow them to afford health care. These are the people who sell us our shirts, our shoes, our fast food, and those who cut our hair. The icon of the middle class—the shopping mall—is staffed largely by the uninsured.

We have a hard time “seeing” these people since they do not walk into our offices. Those who get sick either self-treat or overload our emergency departments. As a result, they become almost invisible to a health care industry in which, despite advances in community medicine, care begins at the time of an office visit.

And so, medical care in America has a seeming incongruity: Americans spend more money on health care than any other people in the world, yet 25% of them do not have adequate care. On the surface we seem to have a free and open system, unlike other countries in which health care is rationed. As we delve below the surface, however, we find that instead of rationing health care, we limit it to those who can afford it.

Can we open the doors to everyone?

We are in a tailspin: Individual patients drive up costs, which are passed on to other people, who try to recover their ‘fair share’ by overusing services when their turn comes around. —David M. Eddy⁴

The easiest course of action is to simply do nothing and allow US society to continue to devote more resources to health care. This choice, however, is likely not acceptable to that family of 4 that already devotes more than $10,000 per year for this care in direct and indirect costs.

In addition, it may not be financially feasible in the world economy. Managed care organizations pass on their costs to the companies, large and small, that ultimately pay for health care. Most clinicians and lay-persons are all too familiar with the problem of high business costs leading to many US businesses relocating their manufacturing plants in other countries where the costs are lower. One of the leading determinants of the costs of doing business in the United States is the cost of health care for the workers.

Historically, the costs of health care have generally risen at a rate of approximately 3% above the yearly rate of inflation. Eliminating many costs of health care services Table 1 which would be unrealistic—would produce a reduction in health care spending for about 5 years until the continued outpacing of inflation by health care costs would return us to the steady rise we currently are experiencing.

Another cost-sparing approach is to eliminate coverage for potentially beneficial health care services that are not essential. Patients would have the option of obtaining these services, but only if they choose to pay for them at full price. This approach takes away a major incentive that drives up medical costs; patients who pay insurance premiums often want to get their money’s worth, whether or not they need the care. Patients, not physicians, may therefore make decisions concerning whether they would like to pay for beneficial but not absolutely necessary services.

Rationing

I think it’s clear that future generations will marvel at our capacity to invent and document effective health services; let’s hope they will not marvel equally at our failure to deliver access to these services. —Mark Chassin¹

Deciding where the split occurs between necessary and beneficial is not as easy as it sounds. For example, if we had to choose between paying for mammograms for all women starting at age 50 years, or paying for bone marrow transplants for metastatic breast cancer, how would we decide? Would it be fair to ask a 50-year-old woman with metastatic breast cancer, her family, or her doctor? Of course not.

Instead, what would happen if we were able to ask the same 50-year-old woman with breast cancer when she was only 20 years old and cancer free? Which option would she have chosen at that time in her life: mammogram screening starting at age 50 or bone marrow transplant for metastatic cancer? Chances are good that she would have picked periodic mammography screening, since the likelihood of benefit would appear to her to be greater. More likely, though, a woman, her family, and her doctor would want both.

Faced with limited resources, paying for both and not making a choice leaves us in our present position: We don’t ration services in the United States, we ration people.

The R word—rationing—seems to induce the ire of most of us in health care. To many, rationing is defined as “denying necessary health care to persons who need it,” “not allowing people to receive expensive services,” or “interference by government or business entities in the practice of medicine.” Whatever the definition, explicit debate about methods of rationing health care is emotional and seems to focus on issues of a moral nature.

Yet clinicians already ration health care based on need. The patient with crushing substernal chest pain is given more time and effort than the hypochondriacal patient who comes in every month for a reassurance visit. Clinicians frequently make decisions about how to deliver health care based on a comparison of individual need—rationing in its purest form.

Understanding Rationing

This type of rationing is justifiable because it does not seem to violate the patient’s best interest—although patients might derive additional benefit from a few minutes of your time, this benefit would be small and not essential. When discussing rationing of services, one needs to make this crucial distinction between beneficial and necessary services, especially when resources are limited.¹⁶

Several other misunderstandings cloud the concept of rationing.¹⁷ The more-is-better fallacy stipulates that more care is synonymous with better care, and, since rationing limits care, it must be wrong. Research and common sense do not bear out this assumption. The common build-it-and-they-will-come approach to offering new health care services offers many examples of increased care without better outcomes.^18,19

The good-old-days fallacy occurs when we remember fondly those times when we did not have to face the endless frustrations of insurance forms, authorizations and peer-review forms. Unfortunately, getting paid in direct proportion to what services a clinician delivers also directly rewards unnecessary and even harmful interventions.

The Marcus Welby fallacy particularly applies to family physicians and is the most important one to correct. Named after the TV doctor who cared for only 1 patient per week, this fallacy refuses to let us acknowledge that (1) patients have a life outside of our offices, and (2) there are patients outside of our practice who are nonetheless affected by what goes on within our 4 walls.

All clinicians must recognize that always choosing to maximize care for individual patients places these patients, not only in conflict with society, but, ultimately, in conflict with themselves. For example, even though the incremental cost of an expensive versus inexpensive antibiotic for a respiratory infection seems minimal at the time, each of these decisions takes away money in the system that could be used by the same patients later in their life for truly life-threatening infections. In essence, beneficial yet unnecessary care mortgages the patient’s—and society’s—future.

The True Mission

If we fix overuse or misuse problems, we improve quality and reduce costs at the same time. Overuse is ubiquitous in American medicine.¹

Evidence-based medicine, and our derivation, information mastery, evolved as a way to make sense of the incredible amount of information available to practicing physicians so that they might improve their delivery of medical care. Lately the use of evidence-based/outcomes-based medicine techniques have been met with suspicion, especially because nonmedical professionals have embraced this approach.

The true goal of evidence-based medicine and information mastery is to provide effective and efficient care to patients via a health care system that allows all people to receive basic care. To meet this goal, this system has to be reconfigured so that existing resources are used in a way that is fair and equitable to all persons (and not just patients). Costs must be considered.

Improving quality and decreasing costs

The value of health care services can be improved either by improving quality or decreasing costs. This relationship can be conceptualized by the following equation:

Value = Quality Cost

If we decrease cost and compromise quality in the process, we gain nothing and may lose value. This is many clinicians’ greatest concern regarding cost-cutting efforts. If we can raise quality and decrease costs, however, we can significantly improve value.

Improving quality can be accomplished by reducing underuse, overuse, and misuse of medical care. Most current efforts to improve the quality of health care are focused on reducing underuse and are aimed at ways (practice guidelines, peer-review reports, and so forth) to get clinicians to do things they should be doing but are not. The problem, however, is that doing more is expensive and raises costs, thus reducing the amount of value gained as a result of the increase in quality. As a result, the gains are usually minimal and do nothing to lower the costs of health care or to make access universal.

However, it is estimated that we can safely eliminate almost 20% of the things we do in medicine and no one will be harmed as a result.20 The question is: which 20%? The best way to improve quality in the system is to address misuse and overuse of resources by focusing on using interventions that are less expensive, more effective, or both. Protecting our patients from overuse of services prevents them from being exposed to the risks of unnecessary interventions. This process starts by paying attention to what the evidence is telling us about our care. The concept of Patient-Oriented Evidence that Matters grew out of a need to identify information that tells us what treatments allow patients to live longer or better. As valid POEMs accumulate, practices must be changed according to this new and better information Table 2.

Using POEMs as our guide to which services to provide and which to leave out can eliminate waste in medicine, and in so doing, may result in a more fair distribution of resources. This will occur only if free market competition resulting from industry payers or legislation prevents the additional savings from becoming more profits for shareholders. A focus on POEMs will fit into any health care system concerned with proportioning limited resources. Many clinicians and laypersons in the United States connect the idea of rationing with the long waiting lists for health services in Canada and the United Kingdom. Even countries with universal health care access would benefit from eliminating useless or marginally helpful services.

Think Globally, Act Locally: What Each Clinician Should Do

Every dollar that is spent unnecessarily in the care of a healthy person potentially leads to further restrictions on reimbursement, further increases in health insurance premiums, loss of health insurance in borderline cases and, ultimately, fewer available resources for the care of the sicker patients who desperately need them. —Raymond J. Gibbons, MD²¹

Medicine has some very crucial decisions to make in the immediate future involving the allocation of resources, including the appropriate use of antibiotics, screening diabetics for microalbuminuria, screening for osteoporosis using bone densiometry, screening for prostate cancer using the prostate specific antigen test, and the use of routine obstetrical ultrasound. By continuing to provide services that do not improve patient outcomes, we add to the rising costs of health care, which results in fewer patients being able to receive the health care they need.

What can the individual clinician do? Each of us needs to learn about the benefits, harms, and costs of important interventions.²² We need to identify both the unnecessary and underused services and determine with patients if those services are worth the costs. More basic, applied, and practice-based research is needed to determine patient preferences about what information they want or need and how they would like to be included in the decision-making process. In addition, we must take responsibility for incorporating valid POEMs and guidelines into our everyday practice. Finally, we must accept that resources are limited and we can either continue to limit people who receive services, or limit the services themselves.

Practice behaviors this year have a direct effect on the health care budget for next year, both in a fee-for-service and capitated system. Excess spending this year results in fewer patients being insured next year and has a direct impact on how many people can afford coverage or how many individuals a specific company can afford to employ. The money saved by increasing the value of the services we provide (by limiting costs or increasing quality using valid POEMs as a guide to delivering these services) may not result in a direct decrease in the overall cost of health care. It will, however, reduce the yearly increase in health care spending occurring above and beyond the inflation rate. Figure

The role of family medicine

The only thing necessary for the triumph of evil is for good men to do nothing.—attributed to Edmund Burke

The survival of family medicine as an independent specialty is being challenged by competition from other providers and increased control by insurance organizations. These challenges are reflected in the lower number of medical students attracted to the specialty.

What does family medicine have to offer the students who have only the dictatorial dons of medicine or the young, brash hero-docs on “ER” as role models? By comparison, family medicine does not look challenging or sexy. Family medicine must be seen as cutting-edge and patient-centered. To achieve these goals, the specialty must embrace patient-oriented evidence that matters and balance the needs of each individual with the needs of the family and the entire community.

It’s one thing to say that we have evidence that something works. It’s far more important to know how well it works. —David M. Eddy¹

In previous articles in this series on information mastery we outlined the importance of finding, evaluating, and implementing POEMs (Patient-Oriented Evidence that Matters) to maximize patient outcome at the point-of-care. Clinicians practicing as “information masters” will have the information they need when they need it, allowing them to offer their patients the best care.

In this article we take the concept of using POEMs one large and significant step further, and apply it not only to making decisions about individual patients, but also within the context of the entire community and population. Information mastery can improve the value of health delivery systems by increasing quality and controlling costs. By improving the value of health care, physicians should be able to provide universal and equitable health care access for all.

The problem of cost

Our collective complacency for 44 million uninsured is a national disgrace.²

The amount of money spent yearly in the United States for health care continues to rise at a rate faster than the rate of inflation. Whereas in 1960, when 5% of the gross national product was consumed by health care costs, this proportion has increased to 15% in the year 2000.³

Translating this number into actual dollars, the average family of 4 pays at least $10,000 per year in direct and indirect health care costs.⁴ Direct health care costs include insurance premiums and co-pays, and out-of-pocket expenses for medicines and devices. Additional, indirect, health care costs come in the form of higher costs of purchased goods as a result of the burden of paying for the health care of the workers who manufacture and sell the products.

More money is spent, per person, in the United States on health care than in any other country in the world. Approximately 50% more is spent on health care in the United States than is spent in Canada. The United Kingdom spends only about one-third of this amount of money.⁵ Despite this increased spending, average life expectancy is not substantially longer here than in other industrialized countries.^5,6

Socioeconomic status plays a larger role in the United States than health care spending in determining the length and quality of life.^7-12 In a recent study comparing survival rates for 15 “curable” cancers in Toronto, Ontario, and Detroit, Michigan, researchers found that socioeconomic status had no effect on survival for 12 of the 15 cancers occurring in the Canadians. However, patients who were in the lowest economic strata in Detroit had survival rates 40% lower than patients who had greater income did.⁹ Similar results have been found with heart disease,⁷ breast cancer,⁸ and HIV infection,¹¹ and for mortality rates in general across socioeconomic strata.¹³

It is a common assumption among many US lay persons and clinicians that the increase in mortality among the poor is due to an increase in high risk health behaviors, such as smoking, alcohol and drug abuse, obesity, and sedentary lifestyle. However, controlling for age, sex, race, urbanicity, education level, and health risk behaviors, people in the lowest-income group (family income $30,000 per year) have a mortality rate almost three-fold higher than those in the highest income group.¹⁴ This risk is especially high for low-income women, presumably because of inadequate prenatal care.

Despite an unemployment level that is at a 30-year low, more than 44 million people are uninsured, including 11 million children.¹⁵ The number of uninsured people grows at a rate of 100,000 people per month. These uninsured people are termed the “working poor”: persons who work in jobs with an income that makes them ineligible for public assistance programs but is insufficient to allow them to afford health care. These are the people who sell us our shirts, our shoes, our fast food, and those who cut our hair. The icon of the middle class—the shopping mall—is staffed largely by the uninsured.

We have a hard time “seeing” these people since they do not walk into our offices. Those who get sick either self-treat or overload our emergency departments. As a result, they become almost invisible to a health care industry in which, despite advances in community medicine, care begins at the time of an office visit.

And so, medical care in America has a seeming incongruity: Americans spend more money on health care than any other people in the world, yet 25% of them do not have adequate care. On the surface we seem to have a free and open system, unlike other countries in which health care is rationed. As we delve below the surface, however, we find that instead of rationing health care, we limit it to those who can afford it.

Can we open the doors to everyone?

We are in a tailspin: Individual patients drive up costs, which are passed on to other people, who try to recover their ‘fair share’ by overusing services when their turn comes around. —David M. Eddy⁴

The easiest course of action is to simply do nothing and allow US society to continue to devote more resources to health care. This choice, however, is likely not acceptable to that family of 4 that already devotes more than $10,000 per year for this care in direct and indirect costs.

In addition, it may not be financially feasible in the world economy. Managed care organizations pass on their costs to the companies, large and small, that ultimately pay for health care. Most clinicians and lay-persons are all too familiar with the problem of high business costs leading to many US businesses relocating their manufacturing plants in other countries where the costs are lower. One of the leading determinants of the costs of doing business in the United States is the cost of health care for the workers.

Historically, the costs of health care have generally risen at a rate of approximately 3% above the yearly rate of inflation. Eliminating many costs of health care services Table 1 which would be unrealistic—would produce a reduction in health care spending for about 5 years until the continued outpacing of inflation by health care costs would return us to the steady rise we currently are experiencing.

Another cost-sparing approach is to eliminate coverage for potentially beneficial health care services that are not essential. Patients would have the option of obtaining these services, but only if they choose to pay for them at full price. This approach takes away a major incentive that drives up medical costs; patients who pay insurance premiums often want to get their money’s worth, whether or not they need the care. Patients, not physicians, may therefore make decisions concerning whether they would like to pay for beneficial but not absolutely necessary services.

Rationing

I think it’s clear that future generations will marvel at our capacity to invent and document effective health services; let’s hope they will not marvel equally at our failure to deliver access to these services. —Mark Chassin¹

Deciding where the split occurs between necessary and beneficial is not as easy as it sounds. For example, if we had to choose between paying for mammograms for all women starting at age 50 years, or paying for bone marrow transplants for metastatic breast cancer, how would we decide? Would it be fair to ask a 50-year-old woman with metastatic breast cancer, her family, or her doctor? Of course not.

Instead, what would happen if we were able to ask the same 50-year-old woman with breast cancer when she was only 20 years old and cancer free? Which option would she have chosen at that time in her life: mammogram screening starting at age 50 or bone marrow transplant for metastatic cancer? Chances are good that she would have picked periodic mammography screening, since the likelihood of benefit would appear to her to be greater. More likely, though, a woman, her family, and her doctor would want both.

Faced with limited resources, paying for both and not making a choice leaves us in our present position: We don’t ration services in the United States, we ration people.

The R word—rationing—seems to induce the ire of most of us in health care. To many, rationing is defined as “denying necessary health care to persons who need it,” “not allowing people to receive expensive services,” or “interference by government or business entities in the practice of medicine.” Whatever the definition, explicit debate about methods of rationing health care is emotional and seems to focus on issues of a moral nature.

Yet clinicians already ration health care based on need. The patient with crushing substernal chest pain is given more time and effort than the hypochondriacal patient who comes in every month for a reassurance visit. Clinicians frequently make decisions about how to deliver health care based on a comparison of individual need—rationing in its purest form.

Understanding Rationing

This type of rationing is justifiable because it does not seem to violate the patient’s best interest—although patients might derive additional benefit from a few minutes of your time, this benefit would be small and not essential. When discussing rationing of services, one needs to make this crucial distinction between beneficial and necessary services, especially when resources are limited.¹⁶

Several other misunderstandings cloud the concept of rationing.¹⁷ The more-is-better fallacy stipulates that more care is synonymous with better care, and, since rationing limits care, it must be wrong. Research and common sense do not bear out this assumption. The common build-it-and-they-will-come approach to offering new health care services offers many examples of increased care without better outcomes.^18,19

The good-old-days fallacy occurs when we remember fondly those times when we did not have to face the endless frustrations of insurance forms, authorizations and peer-review forms. Unfortunately, getting paid in direct proportion to what services a clinician delivers also directly rewards unnecessary and even harmful interventions.

The Marcus Welby fallacy particularly applies to family physicians and is the most important one to correct. Named after the TV doctor who cared for only 1 patient per week, this fallacy refuses to let us acknowledge that (1) patients have a life outside of our offices, and (2) there are patients outside of our practice who are nonetheless affected by what goes on within our 4 walls.

All clinicians must recognize that always choosing to maximize care for individual patients places these patients, not only in conflict with society, but, ultimately, in conflict with themselves. For example, even though the incremental cost of an expensive versus inexpensive antibiotic for a respiratory infection seems minimal at the time, each of these decisions takes away money in the system that could be used by the same patients later in their life for truly life-threatening infections. In essence, beneficial yet unnecessary care mortgages the patient’s—and society’s—future.

The True Mission

If we fix overuse or misuse problems, we improve quality and reduce costs at the same time. Overuse is ubiquitous in American medicine.¹

Evidence-based medicine, and our derivation, information mastery, evolved as a way to make sense of the incredible amount of information available to practicing physicians so that they might improve their delivery of medical care. Lately the use of evidence-based/outcomes-based medicine techniques have been met with suspicion, especially because nonmedical professionals have embraced this approach.

The true goal of evidence-based medicine and information mastery is to provide effective and efficient care to patients via a health care system that allows all people to receive basic care. To meet this goal, this system has to be reconfigured so that existing resources are used in a way that is fair and equitable to all persons (and not just patients). Costs must be considered.

Improving quality and decreasing costs

The value of health care services can be improved either by improving quality or decreasing costs. This relationship can be conceptualized by the following equation:

Value = Quality Cost

If we decrease cost and compromise quality in the process, we gain nothing and may lose value. This is many clinicians’ greatest concern regarding cost-cutting efforts. If we can raise quality and decrease costs, however, we can significantly improve value.

Improving quality can be accomplished by reducing underuse, overuse, and misuse of medical care. Most current efforts to improve the quality of health care are focused on reducing underuse and are aimed at ways (practice guidelines, peer-review reports, and so forth) to get clinicians to do things they should be doing but are not. The problem, however, is that doing more is expensive and raises costs, thus reducing the amount of value gained as a result of the increase in quality. As a result, the gains are usually minimal and do nothing to lower the costs of health care or to make access universal.

However, it is estimated that we can safely eliminate almost 20% of the things we do in medicine and no one will be harmed as a result.20 The question is: which 20%? The best way to improve quality in the system is to address misuse and overuse of resources by focusing on using interventions that are less expensive, more effective, or both. Protecting our patients from overuse of services prevents them from being exposed to the risks of unnecessary interventions. This process starts by paying attention to what the evidence is telling us about our care. The concept of Patient-Oriented Evidence that Matters grew out of a need to identify information that tells us what treatments allow patients to live longer or better. As valid POEMs accumulate, practices must be changed according to this new and better information Table 2.

Using POEMs as our guide to which services to provide and which to leave out can eliminate waste in medicine, and in so doing, may result in a more fair distribution of resources. This will occur only if free market competition resulting from industry payers or legislation prevents the additional savings from becoming more profits for shareholders. A focus on POEMs will fit into any health care system concerned with proportioning limited resources. Many clinicians and laypersons in the United States connect the idea of rationing with the long waiting lists for health services in Canada and the United Kingdom. Even countries with universal health care access would benefit from eliminating useless or marginally helpful services.

Think Globally, Act Locally: What Each Clinician Should Do

Every dollar that is spent unnecessarily in the care of a healthy person potentially leads to further restrictions on reimbursement, further increases in health insurance premiums, loss of health insurance in borderline cases and, ultimately, fewer available resources for the care of the sicker patients who desperately need them. —Raymond J. Gibbons, MD²¹

Medicine has some very crucial decisions to make in the immediate future involving the allocation of resources, including the appropriate use of antibiotics, screening diabetics for microalbuminuria, screening for osteoporosis using bone densiometry, screening for prostate cancer using the prostate specific antigen test, and the use of routine obstetrical ultrasound. By continuing to provide services that do not improve patient outcomes, we add to the rising costs of health care, which results in fewer patients being able to receive the health care they need.

What can the individual clinician do? Each of us needs to learn about the benefits, harms, and costs of important interventions.²² We need to identify both the unnecessary and underused services and determine with patients if those services are worth the costs. More basic, applied, and practice-based research is needed to determine patient preferences about what information they want or need and how they would like to be included in the decision-making process. In addition, we must take responsibility for incorporating valid POEMs and guidelines into our everyday practice. Finally, we must accept that resources are limited and we can either continue to limit people who receive services, or limit the services themselves.

Practice behaviors this year have a direct effect on the health care budget for next year, both in a fee-for-service and capitated system. Excess spending this year results in fewer patients being insured next year and has a direct impact on how many people can afford coverage or how many individuals a specific company can afford to employ. The money saved by increasing the value of the services we provide (by limiting costs or increasing quality using valid POEMs as a guide to delivering these services) may not result in a direct decrease in the overall cost of health care. It will, however, reduce the yearly increase in health care spending occurring above and beyond the inflation rate. Figure

The role of family medicine

The only thing necessary for the triumph of evil is for good men to do nothing.—attributed to Edmund Burke

The survival of family medicine as an independent specialty is being challenged by competition from other providers and increased control by insurance organizations. These challenges are reflected in the lower number of medical students attracted to the specialty.

What does family medicine have to offer the students who have only the dictatorial dons of medicine or the young, brash hero-docs on “ER” as role models? By comparison, family medicine does not look challenging or sexy. Family medicine must be seen as cutting-edge and patient-centered. To achieve these goals, the specialty must embrace patient-oriented evidence that matters and balance the needs of each individual with the needs of the family and the entire community.

It’s one thing to say that we have evidence that something works. It’s far more important to know how well it works. —David M. Eddy¹

In previous articles in this series on information mastery we outlined the importance of finding, evaluating, and implementing POEMs (Patient-Oriented Evidence that Matters) to maximize patient outcome at the point-of-care. Clinicians practicing as “information masters” will have the information they need when they need it, allowing them to offer their patients the best care.

In this article we take the concept of using POEMs one large and significant step further, and apply it not only to making decisions about individual patients, but also within the context of the entire community and population. Information mastery can improve the value of health delivery systems by increasing quality and controlling costs. By improving the value of health care, physicians should be able to provide universal and equitable health care access for all.

The problem of cost

Our collective complacency for 44 million uninsured is a national disgrace.²

The amount of money spent yearly in the United States for health care continues to rise at a rate faster than the rate of inflation. Whereas in 1960, when 5% of the gross national product was consumed by health care costs, this proportion has increased to 15% in the year 2000.³

Translating this number into actual dollars, the average family of 4 pays at least $10,000 per year in direct and indirect health care costs.⁴ Direct health care costs include insurance premiums and co-pays, and out-of-pocket expenses for medicines and devices. Additional, indirect, health care costs come in the form of higher costs of purchased goods as a result of the burden of paying for the health care of the workers who manufacture and sell the products.

More money is spent, per person, in the United States on health care than in any other country in the world. Approximately 50% more is spent on health care in the United States than is spent in Canada. The United Kingdom spends only about one-third of this amount of money.⁵ Despite this increased spending, average life expectancy is not substantially longer here than in other industrialized countries.^5,6

Socioeconomic status plays a larger role in the United States than health care spending in determining the length and quality of life.^7-12 In a recent study comparing survival rates for 15 “curable” cancers in Toronto, Ontario, and Detroit, Michigan, researchers found that socioeconomic status had no effect on survival for 12 of the 15 cancers occurring in the Canadians. However, patients who were in the lowest economic strata in Detroit had survival rates 40% lower than patients who had greater income did.⁹ Similar results have been found with heart disease,⁷ breast cancer,⁸ and HIV infection,¹¹ and for mortality rates in general across socioeconomic strata.¹³

It is a common assumption among many US lay persons and clinicians that the increase in mortality among the poor is due to an increase in high risk health behaviors, such as smoking, alcohol and drug abuse, obesity, and sedentary lifestyle. However, controlling for age, sex, race, urbanicity, education level, and health risk behaviors, people in the lowest-income group (family income $30,000 per year) have a mortality rate almost three-fold higher than those in the highest income group.¹⁴ This risk is especially high for low-income women, presumably because of inadequate prenatal care.

Despite an unemployment level that is at a 30-year low, more than 44 million people are uninsured, including 11 million children.¹⁵ The number of uninsured people grows at a rate of 100,000 people per month. These uninsured people are termed the “working poor”: persons who work in jobs with an income that makes them ineligible for public assistance programs but is insufficient to allow them to afford health care. These are the people who sell us our shirts, our shoes, our fast food, and those who cut our hair. The icon of the middle class—the shopping mall—is staffed largely by the uninsured.

We have a hard time “seeing” these people since they do not walk into our offices. Those who get sick either self-treat or overload our emergency departments. As a result, they become almost invisible to a health care industry in which, despite advances in community medicine, care begins at the time of an office visit.

And so, medical care in America has a seeming incongruity: Americans spend more money on health care than any other people in the world, yet 25% of them do not have adequate care. On the surface we seem to have a free and open system, unlike other countries in which health care is rationed. As we delve below the surface, however, we find that instead of rationing health care, we limit it to those who can afford it.

Can we open the doors to everyone?

We are in a tailspin: Individual patients drive up costs, which are passed on to other people, who try to recover their ‘fair share’ by overusing services when their turn comes around. —David M. Eddy⁴

The easiest course of action is to simply do nothing and allow US society to continue to devote more resources to health care. This choice, however, is likely not acceptable to that family of 4 that already devotes more than $10,000 per year for this care in direct and indirect costs.

In addition, it may not be financially feasible in the world economy. Managed care organizations pass on their costs to the companies, large and small, that ultimately pay for health care. Most clinicians and lay-persons are all too familiar with the problem of high business costs leading to many US businesses relocating their manufacturing plants in other countries where the costs are lower. One of the leading determinants of the costs of doing business in the United States is the cost of health care for the workers.

Historically, the costs of health care have generally risen at a rate of approximately 3% above the yearly rate of inflation. Eliminating many costs of health care services Table 1 which would be unrealistic—would produce a reduction in health care spending for about 5 years until the continued outpacing of inflation by health care costs would return us to the steady rise we currently are experiencing.

Another cost-sparing approach is to eliminate coverage for potentially beneficial health care services that are not essential. Patients would have the option of obtaining these services, but only if they choose to pay for them at full price. This approach takes away a major incentive that drives up medical costs; patients who pay insurance premiums often want to get their money’s worth, whether or not they need the care. Patients, not physicians, may therefore make decisions concerning whether they would like to pay for beneficial but not absolutely necessary services.

Rationing

I think it’s clear that future generations will marvel at our capacity to invent and document effective health services; let’s hope they will not marvel equally at our failure to deliver access to these services. —Mark Chassin¹

Deciding where the split occurs between necessary and beneficial is not as easy as it sounds. For example, if we had to choose between paying for mammograms for all women starting at age 50 years, or paying for bone marrow transplants for metastatic breast cancer, how would we decide? Would it be fair to ask a 50-year-old woman with metastatic breast cancer, her family, or her doctor? Of course not.

Instead, what would happen if we were able to ask the same 50-year-old woman with breast cancer when she was only 20 years old and cancer free? Which option would she have chosen at that time in her life: mammogram screening starting at age 50 or bone marrow transplant for metastatic cancer? Chances are good that she would have picked periodic mammography screening, since the likelihood of benefit would appear to her to be greater. More likely, though, a woman, her family, and her doctor would want both.

Faced with limited resources, paying for both and not making a choice leaves us in our present position: We don’t ration services in the United States, we ration people.

The R word—rationing—seems to induce the ire of most of us in health care. To many, rationing is defined as “denying necessary health care to persons who need it,” “not allowing people to receive expensive services,” or “interference by government or business entities in the practice of medicine.” Whatever the definition, explicit debate about methods of rationing health care is emotional and seems to focus on issues of a moral nature.

Yet clinicians already ration health care based on need. The patient with crushing substernal chest pain is given more time and effort than the hypochondriacal patient who comes in every month for a reassurance visit. Clinicians frequently make decisions about how to deliver health care based on a comparison of individual need—rationing in its purest form.

Understanding Rationing

This type of rationing is justifiable because it does not seem to violate the patient’s best interest—although patients might derive additional benefit from a few minutes of your time, this benefit would be small and not essential. When discussing rationing of services, one needs to make this crucial distinction between beneficial and necessary services, especially when resources are limited.¹⁶

Several other misunderstandings cloud the concept of rationing.¹⁷ The more-is-better fallacy stipulates that more care is synonymous with better care, and, since rationing limits care, it must be wrong. Research and common sense do not bear out this assumption. The common build-it-and-they-will-come approach to offering new health care services offers many examples of increased care without better outcomes.^18,19

The good-old-days fallacy occurs when we remember fondly those times when we did not have to face the endless frustrations of insurance forms, authorizations and peer-review forms. Unfortunately, getting paid in direct proportion to what services a clinician delivers also directly rewards unnecessary and even harmful interventions.

The Marcus Welby fallacy particularly applies to family physicians and is the most important one to correct. Named after the TV doctor who cared for only 1 patient per week, this fallacy refuses to let us acknowledge that (1) patients have a life outside of our offices, and (2) there are patients outside of our practice who are nonetheless affected by what goes on within our 4 walls.

All clinicians must recognize that always choosing to maximize care for individual patients places these patients, not only in conflict with society, but, ultimately, in conflict with themselves. For example, even though the incremental cost of an expensive versus inexpensive antibiotic for a respiratory infection seems minimal at the time, each of these decisions takes away money in the system that could be used by the same patients later in their life for truly life-threatening infections. In essence, beneficial yet unnecessary care mortgages the patient’s—and society’s—future.

The True Mission

If we fix overuse or misuse problems, we improve quality and reduce costs at the same time. Overuse is ubiquitous in American medicine.¹

Evidence-based medicine, and our derivation, information mastery, evolved as a way to make sense of the incredible amount of information available to practicing physicians so that they might improve their delivery of medical care. Lately the use of evidence-based/outcomes-based medicine techniques have been met with suspicion, especially because nonmedical professionals have embraced this approach.

The true goal of evidence-based medicine and information mastery is to provide effective and efficient care to patients via a health care system that allows all people to receive basic care. To meet this goal, this system has to be reconfigured so that existing resources are used in a way that is fair and equitable to all persons (and not just patients). Costs must be considered.

Improving quality and decreasing costs

The value of health care services can be improved either by improving quality or decreasing costs. This relationship can be conceptualized by the following equation:

Value = Quality Cost

If we decrease cost and compromise quality in the process, we gain nothing and may lose value. This is many clinicians’ greatest concern regarding cost-cutting efforts. If we can raise quality and decrease costs, however, we can significantly improve value.

Improving quality can be accomplished by reducing underuse, overuse, and misuse of medical care. Most current efforts to improve the quality of health care are focused on reducing underuse and are aimed at ways (practice guidelines, peer-review reports, and so forth) to get clinicians to do things they should be doing but are not. The problem, however, is that doing more is expensive and raises costs, thus reducing the amount of value gained as a result of the increase in quality. As a result, the gains are usually minimal and do nothing to lower the costs of health care or to make access universal.

However, it is estimated that we can safely eliminate almost 20% of the things we do in medicine and no one will be harmed as a result.20 The question is: which 20%? The best way to improve quality in the system is to address misuse and overuse of resources by focusing on using interventions that are less expensive, more effective, or both. Protecting our patients from overuse of services prevents them from being exposed to the risks of unnecessary interventions. This process starts by paying attention to what the evidence is telling us about our care. The concept of Patient-Oriented Evidence that Matters grew out of a need to identify information that tells us what treatments allow patients to live longer or better. As valid POEMs accumulate, practices must be changed according to this new and better information Table 2.

Using POEMs as our guide to which services to provide and which to leave out can eliminate waste in medicine, and in so doing, may result in a more fair distribution of resources. This will occur only if free market competition resulting from industry payers or legislation prevents the additional savings from becoming more profits for shareholders. A focus on POEMs will fit into any health care system concerned with proportioning limited resources. Many clinicians and laypersons in the United States connect the idea of rationing with the long waiting lists for health services in Canada and the United Kingdom. Even countries with universal health care access would benefit from eliminating useless or marginally helpful services.

Think Globally, Act Locally: What Each Clinician Should Do

Every dollar that is spent unnecessarily in the care of a healthy person potentially leads to further restrictions on reimbursement, further increases in health insurance premiums, loss of health insurance in borderline cases and, ultimately, fewer available resources for the care of the sicker patients who desperately need them. —Raymond J. Gibbons, MD²¹

Medicine has some very crucial decisions to make in the immediate future involving the allocation of resources, including the appropriate use of antibiotics, screening diabetics for microalbuminuria, screening for osteoporosis using bone densiometry, screening for prostate cancer using the prostate specific antigen test, and the use of routine obstetrical ultrasound. By continuing to provide services that do not improve patient outcomes, we add to the rising costs of health care, which results in fewer patients being able to receive the health care they need.

What can the individual clinician do? Each of us needs to learn about the benefits, harms, and costs of important interventions.²² We need to identify both the unnecessary and underused services and determine with patients if those services are worth the costs. More basic, applied, and practice-based research is needed to determine patient preferences about what information they want or need and how they would like to be included in the decision-making process. In addition, we must take responsibility for incorporating valid POEMs and guidelines into our everyday practice. Finally, we must accept that resources are limited and we can either continue to limit people who receive services, or limit the services themselves.

Practice behaviors this year have a direct effect on the health care budget for next year, both in a fee-for-service and capitated system. Excess spending this year results in fewer patients being insured next year and has a direct impact on how many people can afford coverage or how many individuals a specific company can afford to employ. The money saved by increasing the value of the services we provide (by limiting costs or increasing quality using valid POEMs as a guide to delivering these services) may not result in a direct decrease in the overall cost of health care. It will, however, reduce the yearly increase in health care spending occurring above and beyond the inflation rate. Figure

The role of family medicine

The only thing necessary for the triumph of evil is for good men to do nothing.—attributed to Edmund Burke

The survival of family medicine as an independent specialty is being challenged by competition from other providers and increased control by insurance organizations. These challenges are reflected in the lower number of medical students attracted to the specialty.

What does family medicine have to offer the students who have only the dictatorial dons of medicine or the young, brash hero-docs on “ER” as role models? By comparison, family medicine does not look challenging or sexy. Family medicine must be seen as cutting-edge and patient-centered. To achieve these goals, the specialty must embrace patient-oriented evidence that matters and balance the needs of each individual with the needs of the family and the entire community.

The analysis of the screening mammography data in The Lancet¹ and our subsequent Patient-Oriented Evidence that Matters (POEMs) review² have accomplished an important goal: They got people talking about the benefits versus the risks of this common medical intervention. The practice of evidence-based medicine always begins with a question. The editorial by Dr Woolf³ shows that a POEM review can have the effect of generating questions in the minds of readers.

The analysis of the data supporting screening mammography by Gøtzsche and Olsen¹ focused on 2 limitations of the available research. The first is the appearance of data loss in the trials indicated by differing reports of the number of patients in several of the trials. The databases in these studies are very large (more than 500,000 women have been studied) making them unwieldy and subject to mistakes.

The second limitation found in these trials is the one that causes the most concern: the inadequate concealment of allocation assignment. Researchers enrolling a patient into the trial knew or could have known whether a woman would be in the screened or unscreened group and could have chosen not to enroll a particular patient or type of patient. According to Gøtzsche and Olsen, this knowledge resulted in an imbalance within the 2 groups.

The importance of study design

Along with randomization and blinding, concealed allocation is a way to keep researchers from succumbing to those human traits that get in the way of the scientific method. The Cochrane Collaboration⁴ considers concealed allocation more important than the method of randomization for preventing the introduction of bias into a study, and others⁵ consider it essential for the prevention of selection bias.⁴ This lack of concealed allocation is a serious flaw—not a random error for which a meta-analysis of multiple studies can compensate—that can be responsible for the same bias occurring over and over in different studies, as was demonstrated in this analysis. Studies without concealed allocation may markedly overestimate a benefit of treatment.^5-8

The issues of study design seem to be technical nitpicking until one realizes that the difference in deaths of women screened for breast cancer compared with those who were not screened was only 65 out of a population of almost 0.5 million women. Although the screening may have benefited many women, this benefit has to be weighed against the lack of benefit or actual harm that might have been experienced by others. Ewart⁹ has discussed the ethics of screening programs such as this one and concluded that screening tests must be shown to be beneficial beyond a reasonable doubt before widespread use. The article by Gøtzsche and Olsen and the POEM review suggest that this criterion is not met with our current research.

The POEMs process

The primary goal of the POEMs section in JFP is to present relevant and accurate new research findings in a way that makes them accessible to the busy practicing clinician.* The studies are rigorously evaluated in a redundant process by the primary writer of the review, an editor, members of our editorial board at the University of Missouri, and a supervising editor. In recognition of the fact that the typical clinician has fewer than 30 minutes per week to devote to foraging for new information, each review is limited to 700 words or less. In this short space we try to achieve a balance of information that is clear and concise yet points out the limitations of the research. Reviews that painstakingly outline the complete critical appraisal for each article would be complete but essentially unreadable for all but the most fanatical reader.

The best available evidence

As stated by Dr Woolf, clinical practice guidelines that are based on and linked to clinical evidence are excellent tools for directing practice decisions. However, guidelines often take years to produce, may be influenced by politics more than an explicit evaluation of the best evidence,^10,11 and are not available for many clinical problems. Physicians must act now, using the best available evidence, and they must know today how to integrate a new research finding into their clinical practices. Some articles should change practice. We focus on articles that use patient-oriented outcomes, because we feel that these are much less susceptible to the ping-pong seen when the focus is on disease-oriented outcomes.

As our technological armamentarium increases in size and invasiveness, it is important that we remember the dictum primum non nocere (first do no harm). These days we can do a lot of harm if we are not careful. Absolute certainty is absolutely impossible, and we do not have to wait for that, of course. The results of the reanalysis of the mammography research data suggest no benefit. We evaluated this analysis and reported the results in the POEMs review. It caused several people to ask questions.,¹² That is a good thing.

The analysis of the screening mammography data in The Lancet¹ and our subsequent Patient-Oriented Evidence that Matters (POEMs) review² have accomplished an important goal: They got people talking about the benefits versus the risks of this common medical intervention. The practice of evidence-based medicine always begins with a question. The editorial by Dr Woolf³ shows that a POEM review can have the effect of generating questions in the minds of readers.

The analysis of the data supporting screening mammography by Gøtzsche and Olsen¹ focused on 2 limitations of the available research. The first is the appearance of data loss in the trials indicated by differing reports of the number of patients in several of the trials. The databases in these studies are very large (more than 500,000 women have been studied) making them unwieldy and subject to mistakes.

The second limitation found in these trials is the one that causes the most concern: the inadequate concealment of allocation assignment. Researchers enrolling a patient into the trial knew or could have known whether a woman would be in the screened or unscreened group and could have chosen not to enroll a particular patient or type of patient. According to Gøtzsche and Olsen, this knowledge resulted in an imbalance within the 2 groups.

The importance of study design

Along with randomization and blinding, concealed allocation is a way to keep researchers from succumbing to those human traits that get in the way of the scientific method. The Cochrane Collaboration⁴ considers concealed allocation more important than the method of randomization for preventing the introduction of bias into a study, and others⁵ consider it essential for the prevention of selection bias.⁴ This lack of concealed allocation is a serious flaw—not a random error for which a meta-analysis of multiple studies can compensate—that can be responsible for the same bias occurring over and over in different studies, as was demonstrated in this analysis. Studies without concealed allocation may markedly overestimate a benefit of treatment.^5-8

The issues of study design seem to be technical nitpicking until one realizes that the difference in deaths of women screened for breast cancer compared with those who were not screened was only 65 out of a population of almost 0.5 million women. Although the screening may have benefited many women, this benefit has to be weighed against the lack of benefit or actual harm that might have been experienced by others. Ewart⁹ has discussed the ethics of screening programs such as this one and concluded that screening tests must be shown to be beneficial beyond a reasonable doubt before widespread use. The article by Gøtzsche and Olsen and the POEM review suggest that this criterion is not met with our current research.

The POEMs process

The primary goal of the POEMs section in JFP is to present relevant and accurate new research findings in a way that makes them accessible to the busy practicing clinician.* The studies are rigorously evaluated in a redundant process by the primary writer of the review, an editor, members of our editorial board at the University of Missouri, and a supervising editor. In recognition of the fact that the typical clinician has fewer than 30 minutes per week to devote to foraging for new information, each review is limited to 700 words or less. In this short space we try to achieve a balance of information that is clear and concise yet points out the limitations of the research. Reviews that painstakingly outline the complete critical appraisal for each article would be complete but essentially unreadable for all but the most fanatical reader.

The best available evidence

As stated by Dr Woolf, clinical practice guidelines that are based on and linked to clinical evidence are excellent tools for directing practice decisions. However, guidelines often take years to produce, may be influenced by politics more than an explicit evaluation of the best evidence,^10,11 and are not available for many clinical problems. Physicians must act now, using the best available evidence, and they must know today how to integrate a new research finding into their clinical practices. Some articles should change practice. We focus on articles that use patient-oriented outcomes, because we feel that these are much less susceptible to the ping-pong seen when the focus is on disease-oriented outcomes.

As our technological armamentarium increases in size and invasiveness, it is important that we remember the dictum primum non nocere (first do no harm). These days we can do a lot of harm if we are not careful. Absolute certainty is absolutely impossible, and we do not have to wait for that, of course. The results of the reanalysis of the mammography research data suggest no benefit. We evaluated this analysis and reported the results in the POEMs review. It caused several people to ask questions.,¹² That is a good thing.

The analysis of the screening mammography data in The Lancet¹ and our subsequent Patient-Oriented Evidence that Matters (POEMs) review² have accomplished an important goal: They got people talking about the benefits versus the risks of this common medical intervention. The practice of evidence-based medicine always begins with a question. The editorial by Dr Woolf³ shows that a POEM review can have the effect of generating questions in the minds of readers.

The analysis of the data supporting screening mammography by Gøtzsche and Olsen¹ focused on 2 limitations of the available research. The first is the appearance of data loss in the trials indicated by differing reports of the number of patients in several of the trials. The databases in these studies are very large (more than 500,000 women have been studied) making them unwieldy and subject to mistakes.

The second limitation found in these trials is the one that causes the most concern: the inadequate concealment of allocation assignment. Researchers enrolling a patient into the trial knew or could have known whether a woman would be in the screened or unscreened group and could have chosen not to enroll a particular patient or type of patient. According to Gøtzsche and Olsen, this knowledge resulted in an imbalance within the 2 groups.

The importance of study design

Along with randomization and blinding, concealed allocation is a way to keep researchers from succumbing to those human traits that get in the way of the scientific method. The Cochrane Collaboration⁴ considers concealed allocation more important than the method of randomization for preventing the introduction of bias into a study, and others⁵ consider it essential for the prevention of selection bias.⁴ This lack of concealed allocation is a serious flaw—not a random error for which a meta-analysis of multiple studies can compensate—that can be responsible for the same bias occurring over and over in different studies, as was demonstrated in this analysis. Studies without concealed allocation may markedly overestimate a benefit of treatment.^5-8

The issues of study design seem to be technical nitpicking until one realizes that the difference in deaths of women screened for breast cancer compared with those who were not screened was only 65 out of a population of almost 0.5 million women. Although the screening may have benefited many women, this benefit has to be weighed against the lack of benefit or actual harm that might have been experienced by others. Ewart⁹ has discussed the ethics of screening programs such as this one and concluded that screening tests must be shown to be beneficial beyond a reasonable doubt before widespread use. The article by Gøtzsche and Olsen and the POEM review suggest that this criterion is not met with our current research.

The POEMs process

The primary goal of the POEMs section in JFP is to present relevant and accurate new research findings in a way that makes them accessible to the busy practicing clinician.* The studies are rigorously evaluated in a redundant process by the primary writer of the review, an editor, members of our editorial board at the University of Missouri, and a supervising editor. In recognition of the fact that the typical clinician has fewer than 30 minutes per week to devote to foraging for new information, each review is limited to 700 words or less. In this short space we try to achieve a balance of information that is clear and concise yet points out the limitations of the research. Reviews that painstakingly outline the complete critical appraisal for each article would be complete but essentially unreadable for all but the most fanatical reader.

The best available evidence

As stated by Dr Woolf, clinical practice guidelines that are based on and linked to clinical evidence are excellent tools for directing practice decisions. However, guidelines often take years to produce, may be influenced by politics more than an explicit evaluation of the best evidence,^10,11 and are not available for many clinical problems. Physicians must act now, using the best available evidence, and they must know today how to integrate a new research finding into their clinical practices. Some articles should change practice. We focus on articles that use patient-oriented outcomes, because we feel that these are much less susceptible to the ping-pong seen when the focus is on disease-oriented outcomes.

As our technological armamentarium increases in size and invasiveness, it is important that we remember the dictum primum non nocere (first do no harm). These days we can do a lot of harm if we are not careful. Absolute certainty is absolutely impossible, and we do not have to wait for that, of course. The results of the reanalysis of the mammography research data suggest no benefit. We evaluated this analysis and reported the results in the POEMs review. It caused several people to ask questions.,¹² That is a good thing.

One of the greatest pains to human nature is the pain of a new idea.

Medicine, like most professions, is in danger from a tsunami created by the information explosion of the 1990s. This tidal wave of information, as well as its push-button accessibility, is threatening the basic foundations of the profession. The clinician is no longer considered the exclusive interpreter of medical wisdom and the sole arbiter of what is best for patients. Government agencies, managed care organizations, the news media, and advocacy groups all use medical information to influence patient care. All of these groups are constantly monitoring medical research to determine whether we are changing the way we practice when new and better information comes along.

In this article, we focus on how we learn from this information. From that perspective we will talk about how to change, since change is the ultimate goal of information use.

Why is change so important? The advent of new diagnostic tests, procedures, and medications make it necessary for us to change on a regular basis. Every clinician must change practice habits many times during a career. One can choose either to lead change or be dragged along behind it.

Our article is not about reacting to outside attempts to induce change, the carrots or sticks used by agencies and organizations to motivate us do something different. It is about truly being a master of information rather than its servant.

Information and change: How we learn

At the beginning of life, our minds are like empty shelves in a grocery store. As we learn, we stock them with units of information. Much of our lives are spent filling those shelves with the things we have learned.

Like bread in the grocery store, our information becomes stale and eventually expires. As we continue the lifelong learning process, we replace what has gone stale with fresh units of information. Unfortunately unlike the grocer’s shelves, the information gathered during medical school and in practice does not have an expiration date stamped on it. As a result, we may not know when our existing information has become stale or invalid. And similar to a loaf of stale bread, the information that we store can appear fresh, even though it is past its expiration date.

This lack of expiration labeling makes the job of the information master much more difficult. We need to search continually for new information to discover when our existing information has become outdated.

Think about the information that has become available in the last 10 years: antibiotics for treatment of peptic ulcer disease, the ineffectiveness and possible harm of patching corneal abrasions, therapy of deep venous thrombosis changing from 14 days of hospitalization to at-home treatment, and angiotensin-converting enzyme inhibitors and b-blockers used instead of digoxin as the cornerstone of heart failure therapy. To do what is best for patients, we need to identify new information and assimilate it into daily practice. Maintaining best practices requires change.

In our first paper, we distinguished “data” and “information” from the “knowledge” and “wisdom” that are the results of our brainpower. As a critical prerequisite to change, we must separate our view of ourselves from the information we have. Our value—to individual patients as well as society—is based on our ability to think using the information we accumulate.^11,12 Descartes said, “I think, therefore I am,” not “I know a lot, therefore I am.” We can only think best when we have the best information. Information is useless without reflection and questioning.

Too often we get so attached to hard-earned knowledge that we get defensive when it is challenged by new information. We might interpret evidence requiring us to change as an assault on the integrity of our previous education (and so, in some ways, an attack on our very being).

But information only affects our decisions: It does not change our ability to think. The correct decisions of 5, 10, or 20 years ago were based on the best information available at that time. New evidence, however, requires that we change the way we think about things.

Barriers to Change

Humans spend their lives resisting change.

The idea of change seems self-evident: If people want to change, they will. However, it is not that simple. Many smokers want to quit. Many overweight people want to become svelte. There is a large gulf between wanting to change a behavior and actually changing it.

Several barriers get in the way of this process of change. Fear, discomfort with ambiguity, guilt, and loss of control top the list of reasons for resistance to change. The Figure 1 illustrates some of the factors that have an impact on the process of change. Another barrier is a lack of awareness of information. Sometimes, even when information is found, it may not seem trustworthy. We may think that the information is flawed, that our patients are different from those in the study, or that the results are not applicable to a particular patient. Or we may be uncomfortable with straying from the pack. Fear of lawsuits, bowing to authority, and the “we’ve-never-done-it-that-way-before” syndrome can keep us from doing something new and different.

Changing Yourself

For most doctors, change is virtually a routine part of life…. The alternative to controlling the process of change is to be controlled by it, and in dramatic cases, to experience professional or personal collapse.

Taking control of learning requires the prerequisites outlined in the Table 1. The process of change has 5 steps: obtaining new information; deciding, based on that information, that a new approach may be better; deciding to use a new approach; implementing it; and confirming that this change is beneficial. Below are several ideas to make these steps easier.

Become a Reflective Clinician

The process of change begins with reflection in action: thinking about what you are doing while you are doing it. This introspection, often confused with clinical experience, allows you to identify, though not necessarily fix, those aspects of practice you feel uncertain about. The first requirement of change is the identification of tried-and-true, yet not wholly satisfactory, modes of patient management. Ask yourself: What am I doing in my practice, and why am I doing it?

The next step is to open our minds to the idea of change. Our value lies in our analytical skills and our ability to synthesize information, not in being storehouses of facts. We need to work hard to cultivate the talent to question all things, especially our own knowledge.

Once our minds are open, we need to listen. We have to hear what patients are saying between the lines. We have to take the letters from insurance carriers concerning prescribing or referral habits out of the trash and see what they have to say. Find out what is behind their pronouncements, not for argument’s sake, but to analyze and understand the information.

Many of us get defensive when we realize that our practice habits can be improved. We are not used to nonsuccess of any sort. We get embarrassed, feel threatened and then guilty. Anything short of perceived perfection is threatening. Information mastery means realizing there is much we do not know. The first step to knowledge is the confession of ignorance. We need to look for ways to become free of self-deception (take off the rose-colored glasses) by looking beyond the dogma.

Determine Patient-Oriented Outcomes of Importance

There are many questions that have not been answered by the science of medicine. We know much less about the optimal care of patients than most of us care to confess.

Information masters know that there is much work to be done to shore up the science that supports medicine. Recent studies have shown that only approximately half of the best clinical information is based on good evidence. For example, the latest anticoagulation guidelines were developed using the highest quality evidence only 44% of the time.

Nonetheless, everyone needs to figure out the patient-oriented outcomes of importance to their patients. Start with the concept that patients want to live long healthy symptom-free productive lives. What are you willing to do to meet this goal? Independent thinking is a necessary requirement for exploration of new ideas.

Develop Information Skills

There are several skills necessary for becoming an effective information manager. All of us need to develop quick ways of identifying new information and evaluating its validity. We can begin by being discriminating in our sources of information, since the easiest source may not be the best.

Hunt and forage. Most of us seek information in 2 ways. Sometimes we hunt, searching for information to answer specific questions. To hunt for information, we need to assemble sources that will allow us to find what we need in the least amount of time. Some computerized sources of information are designed to lead us to well-validated, predigested information within 1 minute of starting. InfoRetriever, The Cochrane Database of Systematic Reviews, and Best Evidence, are CD-based databases that provide validated information in an easily searchable format.* In addition, various Internet sites are available that give access to valid, predigested information, including this journal’s POEMs online (www.infopoems.com), Bandolier (www.jr2.ox.ac.uk/Bandolier), Dr’s Desk (drsdesk.sghms.ac.uk), the TRIP database (www.ceres.uwcm.ac.uk), and DynaMed (www.dynamicmedical.com).

At other times we forage; rummaging for new information. To stay up to date, it is necessary to develop an information-gathering plan. This is not as onerous as it sounds. We can use POEM bulletin boards to keep on top of new information. These sources, such as Evidence-Based Practice, Evidence-Based Medicine, and ACP Journal Club, use specific criteria to identify and present the results of studies that investigate patient-oriented outcomes.

We need to forage and hunt to keep up to date and to find information as necessary. Without both, you do not know what you are looking for and cannot find it when you do.

Use YODAs. In the Star Wars mythology, Yoda is a mentor who provides guidance and interpretation. In a previous paper we defined a YODA—Your Own Data Analyzer—as a person or source of information that can take the best information available, analyze it to determine whether it is valid, and interpret it within the context of clinical practice. In medical practice, we need to identify our own YODAs and also be one for others.

A YODA can be a colleague or someone in the community who has demonstrated an understanding of evidence-based medicine. We need to identify our YODAs, and ask them regularly for their thoughts on issues we confront in practice. Do not rely solely on their pronouncements, however; ask them to identify the evidence supporting their assertions.

An alternative to local YODAs are published YODAs, such as The Cochrane Library a database of meta-analyses, or the POEMs column and the evidence-based reviews in The Journal of Family Practice. Both the Journal’s evidence-based reviews section and the Cochrane database start with a clinical question and employ all of the valid research literature on the topic to formulate an answer based on the best available evidence. The Cochrane database is available on compact disk or at the Cochrane Collaboration’s Web site (www.updateusa.com/clibip/clib.htm).

In addition to identifying YODAs, we should strive to become one. No one can be an expert on everything in medicine, but we can all become one on a few topics that we find especially interesting. For those topics, know the literature. Become a resource. Once we have developed the confidence in our own YODA-hood, we can be one for others. Our positive influence on our colleagues will help them and their patients.

Be discriminating in CME participation. Choose your continuing medical education (CME) time carefully. The research is quite clear: Most people retain very little information presented at CME conferences. Two options present themselves: (1) pick useful CME; or (2) use the opportunity as an excuse to go to a fun locale. If you decide on the first option, work to identify CME opportunities that use interactive formats, such as workshops during which YODAs present evidence that can be evaluated for validity. Not all evidence-based medicine CME conferences meet this criterion.

Whether listening to a speaker or talking with a colleague or consultant, keep in mind the golden question: “That’s interesting … what evidence supports that idea?” There are hundreds of ways to ask that question diplomatically. It is not a judgment or an accusation, but simply a way to further understand the strength of a recommendation or clinical practice. If it is not a valid POEM, it is not necessarily useful information.

You may also need to spend some time tracking down the information supporting the speaker’s conclusions. Speakers may not have that information at their fingertips but they may be able to point you in the right direction. Always write down your questions for follow-up later.

Learn by doing. We learn best by doing. Consider setting up a practice-based small-group CME.³³ Set aside time each month to work with colleagues to answer clinical questions. Decide on a clinical question, find information to answer it, and use the monthly meeting time to present and discuss the information with others in the group.

The development of practice protocols or guidelines is an easy outgrowth of this type of CME activity. Many opportunities exist to get involved in local guideline or protocol development at your hospital or managed care organization. Use the opportunity to learn and teach. Guidelines have their greatest impact on those who are instrumental in developing them.

Finally, we should teach our pharmaceutical representatives to bring us POEMs. Tell them that physicians do not have time for interesting but irrelevant information; we want evidence that shows their product is safer, more tolerable, more effective, less expensive, or simpler to use than the alternatives. Do not let them schedule reminder appointments; tell them we do not want to see them unless their information is new and important to our patients.³⁴

Make the Change a Part of Practice

We are not finished once we have simply decided to change. We have to make the change part of our practice routine. Our subconscious tendency is to resist change—especially large changes. Doing something differently requires more than good intentions.

We should start by sharing what we have learned with others. One of the best ways to learn something is to teach it to others. (As we noted in a previous article, the only one who really learns anything from a CME presentation is the presenter.²)

Another method of incorporating change is to break down the barriers to change by getting everyone on the same team. Relationships within a medical practice (or in a medical community) can be parasitic, competitive, or complementary. Medical offices staffed by personnel with parasitic relationships do not succeed because they destroy the practice from within. Competitive relationships within a practice—pitting physicians against one another or professional staff against administrative staff—drain energy from everyone. Complementary relationships in a practice, however, overcome barriers, foster an atmosphere of teamwork, and most important, allow everyone to teach everyone else. In one of our offices, the expert source of vaccine-related information is not an physician or a pharmacist, but a nurse who can quote dosing information and Centers for Disease Control recommendations. She regularly updates the staff on vaccination issues.

Another idea is to change processes rather than ourselves. Some behaviors can not change until we change the underlying structure of practice.³⁵ This is a central concept of continuous quality improvement. For example, if we decide to let men make their own decision regarding prostate cancer screening, we must make sure that patient information sheets about the test are within easy reach. And instead of having to remember to examine the feet of every patient with diabetes at each visit as outlined in recent guidelines, we can institute a policy in which all of these patients are instructed to take off their shoes and socks at each visit.

Everyone in the office can be involved in process change. Involve all of the staff, from the nurses to the administration staff, in identifying patients who need a flu shot or who are still smoking, so one person does not have to remember it all. Be goal oriented. Keep the big picture in mind. Set the boat’s destination, and let everyone help do the rowing.

Conclusions

Change before you have to.

Change begins with a questioning mind searching for new and better information. The development of the skills necessary to find and evaluate information should follow. And implementing the changes of ingrained habits is the final and most difficult part of the process.

Evidence that matters is information that requires a change in practice. Information mastery is necessary because of the core value of all health care: we strive to do what is best for patients. When presented with valid evidence that will improve the quality of care of our patients, we must accept the challenge and the responsibility of changing our behavior and implementing those changes in our practices.

One of the greatest pains to human nature is the pain of a new idea.

Medicine, like most professions, is in danger from a tsunami created by the information explosion of the 1990s. This tidal wave of information, as well as its push-button accessibility, is threatening the basic foundations of the profession. The clinician is no longer considered the exclusive interpreter of medical wisdom and the sole arbiter of what is best for patients. Government agencies, managed care organizations, the news media, and advocacy groups all use medical information to influence patient care. All of these groups are constantly monitoring medical research to determine whether we are changing the way we practice when new and better information comes along.

In this article, we focus on how we learn from this information. From that perspective we will talk about how to change, since change is the ultimate goal of information use.

Why is change so important? The advent of new diagnostic tests, procedures, and medications make it necessary for us to change on a regular basis. Every clinician must change practice habits many times during a career. One can choose either to lead change or be dragged along behind it.

Our article is not about reacting to outside attempts to induce change, the carrots or sticks used by agencies and organizations to motivate us do something different. It is about truly being a master of information rather than its servant.

Information and change: How we learn

At the beginning of life, our minds are like empty shelves in a grocery store. As we learn, we stock them with units of information. Much of our lives are spent filling those shelves with the things we have learned.

Like bread in the grocery store, our information becomes stale and eventually expires. As we continue the lifelong learning process, we replace what has gone stale with fresh units of information. Unfortunately unlike the grocer’s shelves, the information gathered during medical school and in practice does not have an expiration date stamped on it. As a result, we may not know when our existing information has become stale or invalid. And similar to a loaf of stale bread, the information that we store can appear fresh, even though it is past its expiration date.

This lack of expiration labeling makes the job of the information master much more difficult. We need to search continually for new information to discover when our existing information has become outdated.

Think about the information that has become available in the last 10 years: antibiotics for treatment of peptic ulcer disease, the ineffectiveness and possible harm of patching corneal abrasions, therapy of deep venous thrombosis changing from 14 days of hospitalization to at-home treatment, and angiotensin-converting enzyme inhibitors and b-blockers used instead of digoxin as the cornerstone of heart failure therapy. To do what is best for patients, we need to identify new information and assimilate it into daily practice. Maintaining best practices requires change.

In our first paper, we distinguished “data” and “information” from the “knowledge” and “wisdom” that are the results of our brainpower. As a critical prerequisite to change, we must separate our view of ourselves from the information we have. Our value—to individual patients as well as society—is based on our ability to think using the information we accumulate.^11,12 Descartes said, “I think, therefore I am,” not “I know a lot, therefore I am.” We can only think best when we have the best information. Information is useless without reflection and questioning.

Too often we get so attached to hard-earned knowledge that we get defensive when it is challenged by new information. We might interpret evidence requiring us to change as an assault on the integrity of our previous education (and so, in some ways, an attack on our very being).

But information only affects our decisions: It does not change our ability to think. The correct decisions of 5, 10, or 20 years ago were based on the best information available at that time. New evidence, however, requires that we change the way we think about things.

Barriers to Change

Humans spend their lives resisting change.

The idea of change seems self-evident: If people want to change, they will. However, it is not that simple. Many smokers want to quit. Many overweight people want to become svelte. There is a large gulf between wanting to change a behavior and actually changing it.

Several barriers get in the way of this process of change. Fear, discomfort with ambiguity, guilt, and loss of control top the list of reasons for resistance to change. The Figure 1 illustrates some of the factors that have an impact on the process of change. Another barrier is a lack of awareness of information. Sometimes, even when information is found, it may not seem trustworthy. We may think that the information is flawed, that our patients are different from those in the study, or that the results are not applicable to a particular patient. Or we may be uncomfortable with straying from the pack. Fear of lawsuits, bowing to authority, and the “we’ve-never-done-it-that-way-before” syndrome can keep us from doing something new and different.

Changing Yourself

For most doctors, change is virtually a routine part of life…. The alternative to controlling the process of change is to be controlled by it, and in dramatic cases, to experience professional or personal collapse.

Taking control of learning requires the prerequisites outlined in the Table 1. The process of change has 5 steps: obtaining new information; deciding, based on that information, that a new approach may be better; deciding to use a new approach; implementing it; and confirming that this change is beneficial. Below are several ideas to make these steps easier.

Become a Reflective Clinician

The process of change begins with reflection in action: thinking about what you are doing while you are doing it. This introspection, often confused with clinical experience, allows you to identify, though not necessarily fix, those aspects of practice you feel uncertain about. The first requirement of change is the identification of tried-and-true, yet not wholly satisfactory, modes of patient management. Ask yourself: What am I doing in my practice, and why am I doing it?

The next step is to open our minds to the idea of change. Our value lies in our analytical skills and our ability to synthesize information, not in being storehouses of facts. We need to work hard to cultivate the talent to question all things, especially our own knowledge.

Once our minds are open, we need to listen. We have to hear what patients are saying between the lines. We have to take the letters from insurance carriers concerning prescribing or referral habits out of the trash and see what they have to say. Find out what is behind their pronouncements, not for argument’s sake, but to analyze and understand the information.

Many of us get defensive when we realize that our practice habits can be improved. We are not used to nonsuccess of any sort. We get embarrassed, feel threatened and then guilty. Anything short of perceived perfection is threatening. Information mastery means realizing there is much we do not know. The first step to knowledge is the confession of ignorance. We need to look for ways to become free of self-deception (take off the rose-colored glasses) by looking beyond the dogma.

Determine Patient-Oriented Outcomes of Importance

There are many questions that have not been answered by the science of medicine. We know much less about the optimal care of patients than most of us care to confess.

Information masters know that there is much work to be done to shore up the science that supports medicine. Recent studies have shown that only approximately half of the best clinical information is based on good evidence. For example, the latest anticoagulation guidelines were developed using the highest quality evidence only 44% of the time.

Nonetheless, everyone needs to figure out the patient-oriented outcomes of importance to their patients. Start with the concept that patients want to live long healthy symptom-free productive lives. What are you willing to do to meet this goal? Independent thinking is a necessary requirement for exploration of new ideas.

Develop Information Skills

There are several skills necessary for becoming an effective information manager. All of us need to develop quick ways of identifying new information and evaluating its validity. We can begin by being discriminating in our sources of information, since the easiest source may not be the best.

Hunt and forage. Most of us seek information in 2 ways. Sometimes we hunt, searching for information to answer specific questions. To hunt for information, we need to assemble sources that will allow us to find what we need in the least amount of time. Some computerized sources of information are designed to lead us to well-validated, predigested information within 1 minute of starting. InfoRetriever, The Cochrane Database of Systematic Reviews, and Best Evidence, are CD-based databases that provide validated information in an easily searchable format.* In addition, various Internet sites are available that give access to valid, predigested information, including this journal’s POEMs online (www.infopoems.com), Bandolier (www.jr2.ox.ac.uk/Bandolier), Dr’s Desk (drsdesk.sghms.ac.uk), the TRIP database (www.ceres.uwcm.ac.uk), and DynaMed (www.dynamicmedical.com).

At other times we forage; rummaging for new information. To stay up to date, it is necessary to develop an information-gathering plan. This is not as onerous as it sounds. We can use POEM bulletin boards to keep on top of new information. These sources, such as Evidence-Based Practice, Evidence-Based Medicine, and ACP Journal Club, use specific criteria to identify and present the results of studies that investigate patient-oriented outcomes.

We need to forage and hunt to keep up to date and to find information as necessary. Without both, you do not know what you are looking for and cannot find it when you do.

Use YODAs. In the Star Wars mythology, Yoda is a mentor who provides guidance and interpretation. In a previous paper we defined a YODA—Your Own Data Analyzer—as a person or source of information that can take the best information available, analyze it to determine whether it is valid, and interpret it within the context of clinical practice. In medical practice, we need to identify our own YODAs and also be one for others.

A YODA can be a colleague or someone in the community who has demonstrated an understanding of evidence-based medicine. We need to identify our YODAs, and ask them regularly for their thoughts on issues we confront in practice. Do not rely solely on their pronouncements, however; ask them to identify the evidence supporting their assertions.

An alternative to local YODAs are published YODAs, such as The Cochrane Library a database of meta-analyses, or the POEMs column and the evidence-based reviews in The Journal of Family Practice. Both the Journal’s evidence-based reviews section and the Cochrane database start with a clinical question and employ all of the valid research literature on the topic to formulate an answer based on the best available evidence. The Cochrane database is available on compact disk or at the Cochrane Collaboration’s Web site (www.updateusa.com/clibip/clib.htm).

In addition to identifying YODAs, we should strive to become one. No one can be an expert on everything in medicine, but we can all become one on a few topics that we find especially interesting. For those topics, know the literature. Become a resource. Once we have developed the confidence in our own YODA-hood, we can be one for others. Our positive influence on our colleagues will help them and their patients.

Be discriminating in CME participation. Choose your continuing medical education (CME) time carefully. The research is quite clear: Most people retain very little information presented at CME conferences. Two options present themselves: (1) pick useful CME; or (2) use the opportunity as an excuse to go to a fun locale. If you decide on the first option, work to identify CME opportunities that use interactive formats, such as workshops during which YODAs present evidence that can be evaluated for validity. Not all evidence-based medicine CME conferences meet this criterion.

Whether listening to a speaker or talking with a colleague or consultant, keep in mind the golden question: “That’s interesting … what evidence supports that idea?” There are hundreds of ways to ask that question diplomatically. It is not a judgment or an accusation, but simply a way to further understand the strength of a recommendation or clinical practice. If it is not a valid POEM, it is not necessarily useful information.

You may also need to spend some time tracking down the information supporting the speaker’s conclusions. Speakers may not have that information at their fingertips but they may be able to point you in the right direction. Always write down your questions for follow-up later.

Learn by doing. We learn best by doing. Consider setting up a practice-based small-group CME.³³ Set aside time each month to work with colleagues to answer clinical questions. Decide on a clinical question, find information to answer it, and use the monthly meeting time to present and discuss the information with others in the group.

The development of practice protocols or guidelines is an easy outgrowth of this type of CME activity. Many opportunities exist to get involved in local guideline or protocol development at your hospital or managed care organization. Use the opportunity to learn and teach. Guidelines have their greatest impact on those who are instrumental in developing them.

Finally, we should teach our pharmaceutical representatives to bring us POEMs. Tell them that physicians do not have time for interesting but irrelevant information; we want evidence that shows their product is safer, more tolerable, more effective, less expensive, or simpler to use than the alternatives. Do not let them schedule reminder appointments; tell them we do not want to see them unless their information is new and important to our patients.³⁴

Make the Change a Part of Practice

We are not finished once we have simply decided to change. We have to make the change part of our practice routine. Our subconscious tendency is to resist change—especially large changes. Doing something differently requires more than good intentions.

We should start by sharing what we have learned with others. One of the best ways to learn something is to teach it to others. (As we noted in a previous article, the only one who really learns anything from a CME presentation is the presenter.²)

Another method of incorporating change is to break down the barriers to change by getting everyone on the same team. Relationships within a medical practice (or in a medical community) can be parasitic, competitive, or complementary. Medical offices staffed by personnel with parasitic relationships do not succeed because they destroy the practice from within. Competitive relationships within a practice—pitting physicians against one another or professional staff against administrative staff—drain energy from everyone. Complementary relationships in a practice, however, overcome barriers, foster an atmosphere of teamwork, and most important, allow everyone to teach everyone else. In one of our offices, the expert source of vaccine-related information is not an physician or a pharmacist, but a nurse who can quote dosing information and Centers for Disease Control recommendations. She regularly updates the staff on vaccination issues.

Another idea is to change processes rather than ourselves. Some behaviors can not change until we change the underlying structure of practice.³⁵ This is a central concept of continuous quality improvement. For example, if we decide to let men make their own decision regarding prostate cancer screening, we must make sure that patient information sheets about the test are within easy reach. And instead of having to remember to examine the feet of every patient with diabetes at each visit as outlined in recent guidelines, we can institute a policy in which all of these patients are instructed to take off their shoes and socks at each visit.

Everyone in the office can be involved in process change. Involve all of the staff, from the nurses to the administration staff, in identifying patients who need a flu shot or who are still smoking, so one person does not have to remember it all. Be goal oriented. Keep the big picture in mind. Set the boat’s destination, and let everyone help do the rowing.

Conclusions

Change before you have to.

Change begins with a questioning mind searching for new and better information. The development of the skills necessary to find and evaluate information should follow. And implementing the changes of ingrained habits is the final and most difficult part of the process.

Evidence that matters is information that requires a change in practice. Information mastery is necessary because of the core value of all health care: we strive to do what is best for patients. When presented with valid evidence that will improve the quality of care of our patients, we must accept the challenge and the responsibility of changing our behavior and implementing those changes in our practices.

One of the greatest pains to human nature is the pain of a new idea.

Medicine, like most professions, is in danger from a tsunami created by the information explosion of the 1990s. This tidal wave of information, as well as its push-button accessibility, is threatening the basic foundations of the profession. The clinician is no longer considered the exclusive interpreter of medical wisdom and the sole arbiter of what is best for patients. Government agencies, managed care organizations, the news media, and advocacy groups all use medical information to influence patient care. All of these groups are constantly monitoring medical research to determine whether we are changing the way we practice when new and better information comes along.

In this article, we focus on how we learn from this information. From that perspective we will talk about how to change, since change is the ultimate goal of information use.

Why is change so important? The advent of new diagnostic tests, procedures, and medications make it necessary for us to change on a regular basis. Every clinician must change practice habits many times during a career. One can choose either to lead change or be dragged along behind it.

Our article is not about reacting to outside attempts to induce change, the carrots or sticks used by agencies and organizations to motivate us do something different. It is about truly being a master of information rather than its servant.

Information and change: How we learn

At the beginning of life, our minds are like empty shelves in a grocery store. As we learn, we stock them with units of information. Much of our lives are spent filling those shelves with the things we have learned.

Like bread in the grocery store, our information becomes stale and eventually expires. As we continue the lifelong learning process, we replace what has gone stale with fresh units of information. Unfortunately unlike the grocer’s shelves, the information gathered during medical school and in practice does not have an expiration date stamped on it. As a result, we may not know when our existing information has become stale or invalid. And similar to a loaf of stale bread, the information that we store can appear fresh, even though it is past its expiration date.

This lack of expiration labeling makes the job of the information master much more difficult. We need to search continually for new information to discover when our existing information has become outdated.

Think about the information that has become available in the last 10 years: antibiotics for treatment of peptic ulcer disease, the ineffectiveness and possible harm of patching corneal abrasions, therapy of deep venous thrombosis changing from 14 days of hospitalization to at-home treatment, and angiotensin-converting enzyme inhibitors and b-blockers used instead of digoxin as the cornerstone of heart failure therapy. To do what is best for patients, we need to identify new information and assimilate it into daily practice. Maintaining best practices requires change.

In our first paper, we distinguished “data” and “information” from the “knowledge” and “wisdom” that are the results of our brainpower. As a critical prerequisite to change, we must separate our view of ourselves from the information we have. Our value—to individual patients as well as society—is based on our ability to think using the information we accumulate.^11,12 Descartes said, “I think, therefore I am,” not “I know a lot, therefore I am.” We can only think best when we have the best information. Information is useless without reflection and questioning.

Too often we get so attached to hard-earned knowledge that we get defensive when it is challenged by new information. We might interpret evidence requiring us to change as an assault on the integrity of our previous education (and so, in some ways, an attack on our very being).

But information only affects our decisions: It does not change our ability to think. The correct decisions of 5, 10, or 20 years ago were based on the best information available at that time. New evidence, however, requires that we change the way we think about things.

Barriers to Change

Humans spend their lives resisting change.

The idea of change seems self-evident: If people want to change, they will. However, it is not that simple. Many smokers want to quit. Many overweight people want to become svelte. There is a large gulf between wanting to change a behavior and actually changing it.

Several barriers get in the way of this process of change. Fear, discomfort with ambiguity, guilt, and loss of control top the list of reasons for resistance to change. The Figure 1 illustrates some of the factors that have an impact on the process of change. Another barrier is a lack of awareness of information. Sometimes, even when information is found, it may not seem trustworthy. We may think that the information is flawed, that our patients are different from those in the study, or that the results are not applicable to a particular patient. Or we may be uncomfortable with straying from the pack. Fear of lawsuits, bowing to authority, and the “we’ve-never-done-it-that-way-before” syndrome can keep us from doing something new and different.

Changing Yourself

For most doctors, change is virtually a routine part of life…. The alternative to controlling the process of change is to be controlled by it, and in dramatic cases, to experience professional or personal collapse.

Taking control of learning requires the prerequisites outlined in the Table 1. The process of change has 5 steps: obtaining new information; deciding, based on that information, that a new approach may be better; deciding to use a new approach; implementing it; and confirming that this change is beneficial. Below are several ideas to make these steps easier.

Become a Reflective Clinician

The process of change begins with reflection in action: thinking about what you are doing while you are doing it. This introspection, often confused with clinical experience, allows you to identify, though not necessarily fix, those aspects of practice you feel uncertain about. The first requirement of change is the identification of tried-and-true, yet not wholly satisfactory, modes of patient management. Ask yourself: What am I doing in my practice, and why am I doing it?

The next step is to open our minds to the idea of change. Our value lies in our analytical skills and our ability to synthesize information, not in being storehouses of facts. We need to work hard to cultivate the talent to question all things, especially our own knowledge.

Once our minds are open, we need to listen. We have to hear what patients are saying between the lines. We have to take the letters from insurance carriers concerning prescribing or referral habits out of the trash and see what they have to say. Find out what is behind their pronouncements, not for argument’s sake, but to analyze and understand the information.

Many of us get defensive when we realize that our practice habits can be improved. We are not used to nonsuccess of any sort. We get embarrassed, feel threatened and then guilty. Anything short of perceived perfection is threatening. Information mastery means realizing there is much we do not know. The first step to knowledge is the confession of ignorance. We need to look for ways to become free of self-deception (take off the rose-colored glasses) by looking beyond the dogma.

Determine Patient-Oriented Outcomes of Importance

There are many questions that have not been answered by the science of medicine. We know much less about the optimal care of patients than most of us care to confess.

Information masters know that there is much work to be done to shore up the science that supports medicine. Recent studies have shown that only approximately half of the best clinical information is based on good evidence. For example, the latest anticoagulation guidelines were developed using the highest quality evidence only 44% of the time.

Nonetheless, everyone needs to figure out the patient-oriented outcomes of importance to their patients. Start with the concept that patients want to live long healthy symptom-free productive lives. What are you willing to do to meet this goal? Independent thinking is a necessary requirement for exploration of new ideas.

Develop Information Skills

There are several skills necessary for becoming an effective information manager. All of us need to develop quick ways of identifying new information and evaluating its validity. We can begin by being discriminating in our sources of information, since the easiest source may not be the best.

Hunt and forage. Most of us seek information in 2 ways. Sometimes we hunt, searching for information to answer specific questions. To hunt for information, we need to assemble sources that will allow us to find what we need in the least amount of time. Some computerized sources of information are designed to lead us to well-validated, predigested information within 1 minute of starting. InfoRetriever, The Cochrane Database of Systematic Reviews, and Best Evidence, are CD-based databases that provide validated information in an easily searchable format.* In addition, various Internet sites are available that give access to valid, predigested information, including this journal’s POEMs online (www.infopoems.com), Bandolier (www.jr2.ox.ac.uk/Bandolier), Dr’s Desk (drsdesk.sghms.ac.uk), the TRIP database (www.ceres.uwcm.ac.uk), and DynaMed (www.dynamicmedical.com).

At other times we forage; rummaging for new information. To stay up to date, it is necessary to develop an information-gathering plan. This is not as onerous as it sounds. We can use POEM bulletin boards to keep on top of new information. These sources, such as Evidence-Based Practice, Evidence-Based Medicine, and ACP Journal Club, use specific criteria to identify and present the results of studies that investigate patient-oriented outcomes.

We need to forage and hunt to keep up to date and to find information as necessary. Without both, you do not know what you are looking for and cannot find it when you do.

Use YODAs. In the Star Wars mythology, Yoda is a mentor who provides guidance and interpretation. In a previous paper we defined a YODA—Your Own Data Analyzer—as a person or source of information that can take the best information available, analyze it to determine whether it is valid, and interpret it within the context of clinical practice. In medical practice, we need to identify our own YODAs and also be one for others.

A YODA can be a colleague or someone in the community who has demonstrated an understanding of evidence-based medicine. We need to identify our YODAs, and ask them regularly for their thoughts on issues we confront in practice. Do not rely solely on their pronouncements, however; ask them to identify the evidence supporting their assertions.

An alternative to local YODAs are published YODAs, such as The Cochrane Library a database of meta-analyses, or the POEMs column and the evidence-based reviews in The Journal of Family Practice. Both the Journal’s evidence-based reviews section and the Cochrane database start with a clinical question and employ all of the valid research literature on the topic to formulate an answer based on the best available evidence. The Cochrane database is available on compact disk or at the Cochrane Collaboration’s Web site (www.updateusa.com/clibip/clib.htm).

In addition to identifying YODAs, we should strive to become one. No one can be an expert on everything in medicine, but we can all become one on a few topics that we find especially interesting. For those topics, know the literature. Become a resource. Once we have developed the confidence in our own YODA-hood, we can be one for others. Our positive influence on our colleagues will help them and their patients.

Be discriminating in CME participation. Choose your continuing medical education (CME) time carefully. The research is quite clear: Most people retain very little information presented at CME conferences. Two options present themselves: (1) pick useful CME; or (2) use the opportunity as an excuse to go to a fun locale. If you decide on the first option, work to identify CME opportunities that use interactive formats, such as workshops during which YODAs present evidence that can be evaluated for validity. Not all evidence-based medicine CME conferences meet this criterion.

Whether listening to a speaker or talking with a colleague or consultant, keep in mind the golden question: “That’s interesting … what evidence supports that idea?” There are hundreds of ways to ask that question diplomatically. It is not a judgment or an accusation, but simply a way to further understand the strength of a recommendation or clinical practice. If it is not a valid POEM, it is not necessarily useful information.

You may also need to spend some time tracking down the information supporting the speaker’s conclusions. Speakers may not have that information at their fingertips but they may be able to point you in the right direction. Always write down your questions for follow-up later.

Learn by doing. We learn best by doing. Consider setting up a practice-based small-group CME.³³ Set aside time each month to work with colleagues to answer clinical questions. Decide on a clinical question, find information to answer it, and use the monthly meeting time to present and discuss the information with others in the group.

The development of practice protocols or guidelines is an easy outgrowth of this type of CME activity. Many opportunities exist to get involved in local guideline or protocol development at your hospital or managed care organization. Use the opportunity to learn and teach. Guidelines have their greatest impact on those who are instrumental in developing them.

Finally, we should teach our pharmaceutical representatives to bring us POEMs. Tell them that physicians do not have time for interesting but irrelevant information; we want evidence that shows their product is safer, more tolerable, more effective, less expensive, or simpler to use than the alternatives. Do not let them schedule reminder appointments; tell them we do not want to see them unless their information is new and important to our patients.³⁴

Make the Change a Part of Practice

We are not finished once we have simply decided to change. We have to make the change part of our practice routine. Our subconscious tendency is to resist change—especially large changes. Doing something differently requires more than good intentions.

We should start by sharing what we have learned with others. One of the best ways to learn something is to teach it to others. (As we noted in a previous article, the only one who really learns anything from a CME presentation is the presenter.²)

Another method of incorporating change is to break down the barriers to change by getting everyone on the same team. Relationships within a medical practice (or in a medical community) can be parasitic, competitive, or complementary. Medical offices staffed by personnel with parasitic relationships do not succeed because they destroy the practice from within. Competitive relationships within a practice—pitting physicians against one another or professional staff against administrative staff—drain energy from everyone. Complementary relationships in a practice, however, overcome barriers, foster an atmosphere of teamwork, and most important, allow everyone to teach everyone else. In one of our offices, the expert source of vaccine-related information is not an physician or a pharmacist, but a nurse who can quote dosing information and Centers for Disease Control recommendations. She regularly updates the staff on vaccination issues.

Another idea is to change processes rather than ourselves. Some behaviors can not change until we change the underlying structure of practice.³⁵ This is a central concept of continuous quality improvement. For example, if we decide to let men make their own decision regarding prostate cancer screening, we must make sure that patient information sheets about the test are within easy reach. And instead of having to remember to examine the feet of every patient with diabetes at each visit as outlined in recent guidelines, we can institute a policy in which all of these patients are instructed to take off their shoes and socks at each visit.

Everyone in the office can be involved in process change. Involve all of the staff, from the nurses to the administration staff, in identifying patients who need a flu shot or who are still smoking, so one person does not have to remember it all. Be goal oriented. Keep the big picture in mind. Set the boat’s destination, and let everyone help do the rowing.

Conclusions

Change before you have to.

Change begins with a questioning mind searching for new and better information. The development of the skills necessary to find and evaluate information should follow. And implementing the changes of ingrained habits is the final and most difficult part of the process.

Evidence that matters is information that requires a change in practice. Information mastery is necessary because of the core value of all health care: we strive to do what is best for patients. When presented with valid evidence that will improve the quality of care of our patients, we must accept the challenge and the responsibility of changing our behavior and implementing those changes in our practices.