Molla S. Donaldson

National Cancer Institute

For several reasons, cancer care is an especially interesting and challenging field. First, cancer is a major cause of mortality. Second, we have a large, rapidly increasing evidence base of what works, promoted in part by strong patient advocacy groups. Third, as more patients survive for longer periods of time, cancer is changing from an acute condition to a chronic condition. Fourth, despite the existence of comprehensive cancer centers, we need new models of care delivery based on the consistent use of evidence about ways to deliver care that meet the needs and expectations of patients and their families.

This year, 1.3 million new cases of cancer will be diagnosed in the United States. Cancer is the second leading cause of death in the United States, accounting for slightly more than 23 percent of all deaths; large disparities in incidence and mortality rates have been found for different racial and ethnic groups, despite the strong evidence base that has been developed for cancer screening, diagnosis, and treatment (DHHS, 2001). Randomized controlled trials (RCTs)—cancer's working models of care—are the gold standard in cancer care. RCTs compare, for example, the best known treatments with new approaches. Based on a few simplified assumptions and a very restricted set of variables, RCTs test the efficacy of new agents or combinations of agents. Based on the results, they put forward hypotheses about how well a model will work and its effectiveness in real-world practice. Only 2.5 percent of adults with cancer are ever involved in clinical trials, and participation in trials varies by age (Sataren et al., 2002). One estimate is that more than half of children younger than 15 are in clinical trials and that findings are quickly translated into pediatric oncology practice (Bleyer et al., 1997).

The evidence base on effective cancer treatment and management has been used as the basis of guidelines that include descriptions of the strength of the evidence for treatment and supportive care for most tumor sites by stage. The guidelines developed by the National Comprehensive Cancer Network, for example, are reviewed annually by standing panels, for a large set of tumor types and are readily available to oncologists (NCCN, 2001) and patients (www.nccn.org). Yet, when researchers studied oncologists' compliance with these guidelines, they found a lot of room for improvement. For example, the appropriate use of guidelines depends on accurate staging, yet many patients are not accurately staged, not staged at all, or staging information is not available to treating clinicians.

The evidence base is also growing because of major advances in basic biology. The implication of the genome project is that oncologists will no longer classify cancers by tumor site (e.g., lung, prostate, pancreas, etc.) but by genetic transcription errors in the germ line (i.e., in the genetic makeup) or in somatic cells. Previously unexplainable differences in patient responses to therapy for tumors that look alike to pathologists are beginning to be understood in terms of the chemical pathways that produce various proteins. Recent advances have raised hopes that molecular profiles and individual phenotypes can be matched to the most effective therapy, something like matching antibiotics to specific bacteria, but at the molecular level.

With earlier diagnosis and more effective treatment, survival times have increased, sometimes making cancer care more like treating a chronic condition than an acute condition; thus, coordinated follow-up care and the late effects of treatment are becoming a central interest. New therapies may also require sustained treatment. Molecular therapies may mean less toxic and more targeted interventions, but they may also mean that patients will have to take pills for a very long time, perhaps even for a lifetime. Successful treatment will also mean that survivors will live much longer, which will shift the emphasis to follow-up care. Like care for other chronic diseases, long-term follow-up care is complex and requires multidisciplinary, multisetting, coordinated services. In addition, early detection may require long-term chemoprevention. Long periods of time may pass during which cells change before genetic defects become evident as tumors, and the distinction between prevention and therapy may disappear as detectable genetic errors are treated long before they are expressed as lesions.

The achievements and promise of genomics, proteomics, and molecular discoveries, however, have not been matched by advances in the organization and delivery of services. When patients are diagnosed with cancer, they often find navigating the medical care system a nightmare. A colleague I had not seen for a while said to me, “When I was diagnosed with Stage 3 melanoma, I thought everyone in the health system would swing into action and take care of me. I didn't realize until much later that no one could or would. It was up to me to make sure things happened and that my doctors knew about it.” She is a patient in a world-class medical center in the Baltimore-Washington area. Despite her education, her considerable resources, her excellent insurance, and her husband who took full-time leave to help her, she was not able to make the system work.

The processes by which a patient accesses care (because of a symptom or for screening), receives a diagnosis, makes decisions, and plans for care in a hospital or outpatient facility or arranges for services from community service and support groups or home care may include initial treatment (such as surgery), follow-up treatment (such as adjuvant chemotherapy or radiation therapy), palliative care, education and information about community services, monitoring as a survivor, and treatment for recurrent disease, continuing primary care, and if needed, timely and appropriate end-of-life care in a hospital, hospice, or home. It may also involve genetic screening, rehabilitation, and support for family and others during and after serious illness. It is easy to understand why when Lee Atwater, campaign manager for Ronald Reagan, was diagnosed with a brain tumor and began treatment, he is reported to have exclaimed, “I need a campaign manager.”

One hears the same complaints from the medical side of health care. Ensuring Quality Cancer Care, a report by the Institute of Medicine National Cancer Policy Board, states emphatically, “There is no national cancer program, care program or system of care in the United States” (IOM, 1999). A pediatric oncologist commented, “In the standard model of delivery of care to pediatric cancer patients, the onus of negotiating all aspects of treatment falls on the patient and his or her family” (Wolfe, 1993).

Figure 1 shows a very common model of health care for cancer. In this distributed model, with oncologists practicing in the community, the patient goes from one doctor and laboratory to another trying to integrate sometimes conflicting information. In addition, oncologists have difficulty obtaining information, which results in waste, duplication of effort, and delays; and the primary care physician often has little information about the patient's treatments. Care is provided in multiple settings, not only at the time of diagnosis and primary treatment, but also over time through later treatments and follow-up, as needed. Recently, interest has grown in the use of “patient navigator” programs to help patients schedule appointments and keep up with their treatment and progress, but I am not aware that such programs have been evaluated for effectiveness (American Cancer Society, 2002; Christensen and Akcasu, 1999).

FIGURE 1

Distributed model of health care for cancer.

Figure 2 shows a different model based on care in a comprehensive cancer center, such as M.D. Anderson, Memorial Sloan Kettering, or Dana Farber, where oncologists and other caregivers are grouped together in one facility. Even in these settings, patients may still go from one caregiver to another, and their records may be quite separate. A care coordinator, such as a nurse oncologist, might help the patient coordinate his or her care, and patients in these centers are more likely to enter clinical trials with stringent protocols and follow-up. In this model, tumor boards or multidisciplinary conferences among oncologists and pathologists develop a plan for patient care. Such conferences, which may be held periodically after primary treatment, may, but usually don't, include the patient and his or her family (Joishy, 2001).

FIGURE 2

Comprehensive cancer center model.

Figure 3, a pediatric multisite model, was developed by Dr. L.C. Wolfe and his colleagues when he was at the New England Medical Center (Wolfe, 1993). The model attempts to remedy the boundary problems at the transitions between settings, particularly between the hospital and home, home care and some outpatient care, and outpatient care and inpatient care. When something goes wrong, people do not always know what to do or who to contact.

FIGURE 3

Pediatric multisite model. Source: Wolfe, 1993.

The model addresses these problems by having the oncologist and the nurse spend time in the hospital together with the patient and then in the outpatient setting and then, as a team, continuing to care for patients who had been in the hospital. To ease the boundary problems between hospital and home care, Wolfe devised an electronic system that enables families to transmit problems and questions to their doctors. O'Connell and colleagues (2000) have critiqued other models of care that try to integrate the hospital-community interface.

Only a few efforts to design better health care delivery systems have been reported. Last week, I attended the annual meeting of the American Society of Clinical Oncology, which drew 25,000 participants from all over the world. Of the more than 3,000 abstracts published, only two reported on programs for improving care. One was a report from France on the number of cancer patients who had attended a nutritional workshop; the other was on the costs and satisfaction of palliative care service in a hospital.

This points up a stark contrast. The knowledge base for the science of cancer care has undergone a radical transformation, but little attention has been paid to ensuring the consistent translation of this knowledge to the health care setting—not just for patients in cancer centers on protocols, but for all cancer patients all the time. Indeed, the assumption seems to be that the results of clinical trials will be translated into practice without error and without specifying how services should be organized and delivered.

The lack of well designed systems can result in the loss of benefits to patients. In many systems, failures can and do occur that could have been addressed by operational engineering. One of the most common consequences is the failure to screen patients. A research project involving health maintenance organizations found that only 50 to 83 percent of women who were expected to have mammographies in a particular year actually had them (Taplin et al., 2002). In Colorado, a risk-management study of lawsuits for failure to diagnose breast cancer found that the average length of delay from symptom to detection or detection to diagnosis was 13.4 months (Marjie G. Harbrect, M.D., personal communication, April 2001). There were many reasons for the delay, but most of them were system problems. In some cases, the primary care clinics did not have systems for tracking or follow-up. In many cases, individuals thought someone else was following up with the patient. Sometimes a lump found in an exam was not visible on a mammogram, and there was simply no follow-up. Failure to diagnose was also found in the United Kingdom, where there was on average a seven-month delay between detection and definitive diagnosis.

A study in New York hospitals on women who clearly should have had adjuvant breast therapy after treatment for early-stage breast cancer found that in hospitals that were part of the Mount Sinai system, only 18 to 33 percent of these patients, depending on the hospital, received their indicated adjuvant therapy for early-stage breast cancer (Bickell and Young, 2001; Bickell et al., 2000). This was not because of a lack of knowledge. After going through the medical records of these patients and talking to the surgeons, the study found that the surgeons simply did not know what had happened to these patients, they had simply “fallen through the cracks.”

Another serious problem is failure to use the evidence base. Dr. Ezekiel Emanuel (2001) at NIH recently reported on an excessive use of chemotherapy for patients in the last months of life. He found that in the last six months, three months, and one month of life, as much chemotherapy was given for tumors that are known to be unresponsive to chemotherapy as for tumors that are responsive to chemotherapy.

Other losses of benefits include: failure to ensure that the necessary information is available at the time of decision making and at the point of care; failure to help with transitions following active treatment; failure to monitor and manage symptoms, including pain; and failure to support dying patients and their families.

A few health systems have reported their attempts to develop an integrated model of care—financially, organizationally, and in data management (Clive, 1997; Demers et al., 1998; Glass, 1998). Other reports include the development of disease-management models of inpatient and outpatient oncology care (Hennings et al., 1998; Piro and Doctor, 1998; Sagebiel, 1996; Uhlenhake, 1995), breast cancer centers (Frost et al., 1999; Kalton et al., 1997), psychosocial support services (McQuellon et al., 1996), support for long-term cancer survivors (Hollen and Hobbie, 1995), and quality improvement teams (Frank and Cramer, 1998).

A remarkable example of what can be accomplished is the use of logistical engineering in the United Kingdom for cancer services (Kerr et al., 2002; NHS Modernisation Agency, 2001; H. Bevan, personal communication, May 2001). The story began with a major comparative study that showed that survival rates in the United Kingdom were low compared to rates in the rest of Europe and the United States. The study also found that therapy was initiated at a much more advanced stage of disease than expected, which resulted in low five-year survival rates. One reason was the seven- to eight-month delay between (1) detection and (2) diagnosis and staging. Patients were also not able to get the radiation therapy they needed, even though 20 to 50 percent of the appointment slots were not used. By the time patients were seen, the plan of care was often outdated or no longer appropriate. Although the patients' needs were predictable, they did not know what to do once they left the hospital. Further, the percentage of patients referred for abnormal exams or test results who will, in fact, have cancer can be predicted. Hence, services could be designed according to a known demand function.

Using such information, the National Health Service (NHS) made improvements in cancer care services a priority. The program began with 50 teams from nine cancer networks; the program has now been expanded to all 34 networks. The project teams tested more than 4,400 changes in the first 12 months and implemented nearly 550 of them. They instituted multidisciplinary teams that meet regularly to manage the experiences of families and caregivers. They revamped services to meet patient and family needs. For example, tests that used to require three separate hospital visits are now done in one visit.

As a result of this initiative, there was, on average, a 50-percent reduction in time to first appointment and a 60-percent reduction in radiology waiting times. The NHS believes the five-year cancer survival rate can be improved by 10 percent and is reengineering systems accordingly.

Engineering can play a major role in accelerating improvements in the quality and efficiency of cancer care. The unique skills of practicing engineers should be applied in six major arenas of cancer care:

1. Redesign care processes using engineering tools, such as the 80/20 rule, continuous flow, mass customization, production planning, and supply-chain manufacturing.
2. Use information technology to make medical information and patient-specific information available when needed. The goal is to ensure that timely, accurate information is available to clinicians and patients when they need to make decisions.
3. Redesign care to include the patient and family in decision making.
4. Encourage the continuous acquisition of knowledge and skills by all health care workers to support multidisciplinary work. The health care workforce must have the expertise to manage complex tasks, which may require changes in training, education, and protocols and rules about which tasks are permitted. Human factors analysis, which has been used in other industries for crew resource management, shift management, ensuring patient and worker safety, and ensuring high-level, reliable performance in dynamic, high-risk settings, should be applied to the health care setting.
5. Care should be coordinated across settings and over time using any engineering tools available.
6. Measurement of performance and outcomes should be used to improve care. This entails measuring the results of practice and removing the distinctions between research and clinical practice environments so that all patients and patient care can increase our knowledge.