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Written Statement

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National Summit on Medical Errors and Patient Safety Research

Panel 1: Consumers and Purchasers

Testimony of Robert F. Meenan, M.D., M.P.H., M.B.A., Secretary, Arthritis Foundation, Dean, Boston University School of Public Health


The first National Summit on Medical Errors and Patient Safety Research was held on September 11, 2000, in Washington, DC. Sponsored by the Quality Interagency Coordination Task Force (QuIC), the Summitís goal was to review the information needs of individuals involved in reducing medical errors and improving patient safety. More importantly, the summit set a coordinated and usable research agenda for the future to answer these identified needs.

Individuals were selected by the Agency for Healthcare Research and Quality (AHRQ) to testify at the summit as members of the witness panels. Each submitted written statements for the record before the event, documenting key issues that they confront with regard to patient safety as well as questions to be researched. Other applicants were invited to submit written statements.

Disclaimer and Copyright Statements


Quality health care is traditionally considered to include elements of structure, process and outcome. Structure refers to the inputs of medical care such as the training level of the physician, the ratio of nurses to patients, and the accreditation status of the health care facility. Process refers to what is actually done to patients. Process includes such elements as sponge counts after surgery, adherence to established treatment guidelines, and the number of laboratory tests ordered per patient visit. Outcome considers the results that the patient actually experiences. Outcomes relevant to patients and physicians include biological status, functional status, and quality of life.

Research on medical errors and patient safety involves an important new emphasis on the process of medical care. Health services research has, of late, focused primarily on outcome rather than process because numerous studies have shown that outcome is not closely related to process. That is, good process may result in poor outcome and vice versa.

Research on medical errors and patient safety involves a renewed focus on the process of medical care. This rationale for this renewed emphasis is based in part on recognizing the work of Demming and other systems experts who have consistently and convincingly documented the strong link between process changes and better outcomes in other fields. It is based in part on work by Wennberg and others that has revealed large and inexplicable variations in process across different health-care settings and different doctors. It is based in part on studies that have shown a disturbingly high frequency of medication errors in the hospital setting. And, it is based on the powerful impact of health care horror stories that involve amputation of the wrong limb or removal of the wrong organ.

This new emphasis on process research has great potential for improving the quality of health care. However, as we increase our emphasis on research into the process of medical care, it is crucial that we design research programs that foster a balanced and comprehensive approach to this intriguing and important area. For many years, our approaches have focused very heavily on fatal diseases, inpatient care, and mainstream medical and surgical therapies. Those approaches are too limited. New efforts in process research must recognize the importance of chronic, disabling diseases, outpatient care, and the full range of commonly used treatments.

The Arthritis Foundation is an organization that represents the needs and interests of 43 million Americans with various forms of chronic, disabling musculoskeletal disease. The Arthritis Foundation believes that new efforts in medical error and patient safety research must incorporate perspectives that are relevant to the process and outcome of care for people with chronic disease. Specifically, the Foundation recommends that the Agency for Healthcare Research and Quality (AHRQ) and its partners incorporate four important perspectives into their new research initiatives on medical errors and patient safety.

  • Research on medical errors and patient safety must not focus exclusively on killer diseases.
  • As Congress has increasingly made clear in its appropriations for the National Institutes of Health (NIH), research expenditures should bear a substantial relationship to the burden of disease. The vast majority of disease burden in this country is caused by chronic illnesses that produce long-term impacts on quality of life, functional status and economic well-being. Chronic disabling conditions cause major limitations in activity for more than 1 of every 10 Americans. Arthritis alone costs the nation $65 billion annually, a figure equivalent to a moderate national recession. Arthritis is also the number one cause of chronic disability for adult Americans. The magnitude of the disease burdens attributable to arthritis and other chronic diseases will increase substantially in the near future as the boomer generation ages.

    Because these conditions are so common and have such profound and pervasive impacts, issues related to the care of arthritis and other chronic diseases deserve substantial consideration in any new program of research on medical errors and patients' safety. Studies should be done to better define the process of care for these diseases. Variations from these best practices should be defined as medical errors, and their causes and corrections should be pursued.

  • Research on medical errors and patient safety should not overemphasize issues of inpatient care.
  • The risks for medical error are undoubtedly high in the hospital setting. However, the cumulative burden of medical errors is almost certainly greater in the outpatient setting, given the substantially higher number of encounters and exposures that occur in those settings. In 1997, adults in this country made 960 million ambulatory care visits, of which 82 percent were to physicians' offices. That same year, there were 31 million discharges from short-stay hospitals. If the number of discharges is multiplied by the average length of stay of 4.4 days, it means that there was roughly seven outpatient encounters that year for every hospital day.

    Incorporating an outpatient perspective into medical error and patient safety research programs is particularly relevant for arthritis and other chronic disorders since people with these conditions have the vast majority of their medical care provided outside of the hospital. Arthritis in particular is almost exclusively cared for in the outpatient setting. With the exception of hospitalizations for joint replacement surgery, people with osteoarthritis and even those with severe rheumatoid arthritis are virtually never cared for in the hospital.

    Outpatient errors also merit consideration apart from inpatient errors because they very likely involve different doctors, different causes and different solutions. Rheumatologists, to take a pertinent example, provide care almost exclusively in the office setting. Efforts to reduce medical errors that focus on the inpatient setting will not improve the care provided by this group of physicians. That, in turn, will not improve the process of care for many people with arthritis.

    Outpatient errors also involve different causes and solutions. The dispensing of medications in the hospital involves a very different process from the dispensing of medications at the local drugstore. Research on errors in hospital drug dispensing will likely provide limited insight into the causes of outpatient prescription errors and their solutions.

  • Research on medical errors and patient safety must not focus exclusively on drugs and surgery.
  • People with chronic illnesses, and people with arthritis in particular, are treated with a variety of modalities including physical therapy, alternative medicine and assistive devices. While errors related to the use of surgery and prescription drugs pose clear risks for patient safety, errors associated with other forms of treatment may also have substantial relevance for patient safety and outcome.

    Once again, the importance of this issue is a product of magnitude of risk times frequency of use. Many people with arthritis receive care from chiropractors. While chiropractic treatment may not be that inherently dangerous, the volume of services involved merits attention in any patient safety research program that considers people with arthritis. Similarly, studies have shown that roughly one-third of Americans use alternative medicines and other unconventional therapies in a given year. Other studies have shown that certain alternative medicines, such as unregulated herbal treatments, may pose substantial risks. This combination of high frequency and mild to moderate inherent risk calls for attention.

  • Research on medical errors and patient safety must not focus exclusively on errors of commission.
  • Medical error may be defined as an unintended act of either omission or commission. While errors of commission, such as operating on the wrong knee, may be more visible and anxiety provoking, errors of omission undoubtedly have an enormous cumulative impact on patient outcomes.

    There is no a priori reason for arguing that errors of commission are inherently more important to patient safety or outcome then are errors of omission. It depends on the disease, the treatment that is given or not given, and other contextual considerations. For example, an error of commission involving the provision of a relatively non-toxic treatment in the setting of a mild disease poses only modest risks for patient safety and outcome. An error of omission involving the failure to provide an effective treatment in the setting of a severe disease poses very substantial risks for patient safety and outcome. And safety and outcome are, after all, the ultimate goals for the patient, the provider and the policy maker.

In summary, as medical error and patient safety concerns increase our focus on the process of medical care, it is crucial that research programs in this exciting area are designed with certain considerations in mind. In their early years, research programs on medical care outcomes focused very heavily on fatal diseases, inpatient care, and traditional therapies. The Arthritis Foundation believes strongly that these orientations involved errors of omission that should not be repeated. New efforts in process research must take a more balanced and comprehensive approach that recognizes the relevance of chronic, disabling diseases, outpatient care, and the full range of commonly used treatments.

Current as of September 2000


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