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Originally published as JCO Early Release 10.1200/JCO.2003.09.979 on November 3 2003 © 2003 American Society for Clinical Oncology
Patterns of Care Studies: Creating "An Environment of Watchful Concern"
1 Dana-Farber Cancer Institute, Boston, MA MEDICINE STANDS out as an enterprise that consumes enormous resources, yet has surprisingly little systematic monitoring of the quality of its output integrated into its operations. Quality medical care has been described as delivering optimal health services1 with technical proficiency,2 and avoiding overuse, underuse, or misuse of technologies.3 The components of quality are usually categorized as structure, process, and outcome. Structure refers to the characteristics of a provider—a physician, institution, or insurer—that allows for good care. These are often the elements that accrediting bodies like the Joint Commission on Accreditation of Healthcare Organizations evaluate, such as physician certification and hospital facilities and capacity. Processes of care are things that are done to patients, in particular whether interventions that are associated with desirable outcome, based on randomized trials or consensus guidelines, are provided to patients. Outcomes such as survival, quality of life, and satisfaction with care are the ultimate components of quality. However, they must be treated with caution because case-mix factors and the time required for some outcomes to occur may make them difficult to compare among providers.4 The idea behind this framework is that structure influences process, process influences outcome, and therefore, structure influences outcome.5 These types of interrelationships justify the common approach of examining adherence to the processes of care as a proxy for overall health care quality. Since 1973, the National Cancer Institute has been funding Patterns of Care Studies (PCS) in radiation oncology with a goal of determining how processes of radiation delivery affect outcomes like local-regional control, treatment-related morbidity and mortality, survival, and quality of life. In particular, the focus has been on documenting patterns of diagnostic methodology, treatment workup, implementation of new research findings, and follow-up care in order "to identify those variables associated with maximizing local control, with the goal of increasing survival and minimizing complications of normal tissues.6" Some of these studies also strive to examine the patterns of care among vulnerable populations, defined based on race, socio-economic status and other variables, in order to identify disparities in care and their sources. Others explore the effect of comorbidity or age on treatment decisions, or the impact of specialized or multidisciplinary approaches on the quality of care. Successful efforts have been carried out in prostate cancer, cervical cancer, Hodgkin’s disease, breast cancer, colorectal cancer, anal cancer, and esophageal cancer. Consequently, the PCS initiative has served as a model for similar programs in other countries.7 In this issue of the Journal, Movsas et al8 present the findings of one such effort examining patterns of radiotherapy delivery in lung cancer, an excellent case because of its dominant role in cancer mortality. They report several worrisome findings. First, staging evaluations of bone and brain scans were not obtained in up to half of patients with stage III non–small-cell lung cancer despite guidelines recommending that they be a routine part of the work-up.9 The study also provides further documentation of remarkably low accrual (just 3%) of patients to clinical trials for a disease in which the majority of patients will not be cured. Additionally, this study re-emphasizes the slow diffusion of "state-of-the-science" cancer care to the general cancer population. For example, despite trial results demonstrating the benefit of prophylactic cranial irradiation in complete remission of small-cell lung cancer and accelerated hyperfractionated radiation for limited disease, these interventions have yet to be systematically adopted. Use of combined-modality therapy in locally advanced non–small-cell lung cancer is gradually increasing, but there is still wide practice variability. Such findings should provoke discussion in the radiation community as to why practitioners have not accepted these procedures into evidence-based care, and efforts should be undertaken to look for ways to overcome practical barriers that may be limiting uptake. To achieve the overarching goal of the PCS, Donabedian10 described the need to create "an environment of watchful concern." The idea is that physicians are generally conscientious and want to provide optimal care. To this end, data need to be presented to the radiation oncology community to educate practitioners about the pretreatment and treatment factors that affect outcome, inform them of the areas in which best practices are not consistently being applied, and develop mechanisms to translate them promptly into practice changes so that the overall quality of care can be improved. If physicians know what the standard of care is, and know that their own practices are being monitored, it will induce them to deliver a higher quality of care. Continuous, timely performance feedback should lead to continuous quality improvement. In "an environment of watchful concern" the type of study conducted by Movsas et al8 would be obsolete. Such research projects are complex, resource-intensive undertakings that only very intermittently report on highly selected topics. Each involves reinventing methods for accessing and assessing inpatient and outpatient medical records, patient and physician surveys, and capturing other data sources. Instead, as the Institute of Medicine urges, we need enhanced health care data collection systems and linkages among systems that make systematic recording and analysis of process and outcome data part of routine quality monitoring and improvement.11 The challenge is to find a practical, rapid, and economically feasible way of creating such a surveillance system for cancer. Unfortunately, none of the current databases is adequate. Tumor registries, like the high-quality registries participating in the Surveillance, Epidemiology, and End-Results program, track incidence, survival, and mortality on a population basis, but aside from initial treatment given or planned within the first few months after diagnosis, are unable to track variation in patterns of care or outcomes such as recurrence. Administrative data, such as billing claims or the Medicare claims files, provide other possibilities as the data already exists, usually in a computer readable format, and it is therefore relatively inexpensive to study large, unbiased samples of patients and to give prompt feedback to providers about how their care compares to objective benchmarks.12 However, there is usually a lack of information about clinical factors, patient preferences, and technical and interpersonal skill. Also, administrative data, by definition, were not created for quality assessment, so their completeness and accuracy are frequently questioned. Linkages between registry and administrative data, such as the Surveillance, Epidemiology, and End-Results program–Medicare linked files, have been productive but are limited largely by the availability of consistent administrative data across insurance carriers. Patient-controlled electronic medical records may eventually serve as the way for capturing entire episodes of care regardless of the setting. However, there are privacy and portability challenges that will need to be addressed. In addition, inconsistent recording of vital data elements may obstruct complete linkages among databases. In response to the Institute of Medicine’s challenge to develop an infrastructure that will enable continuous monitoring and feedback of quality information, the American Society of Clinical Oncology has partnered with a number of organizations to establish National Initiative on Cancer Care Quality (NICCQ). NICCQ is currently evaluating the feasibility of a national system to monitor the quality of cancer care. In consultations with oncologists, methodological experts, and patient advocates, this project has developed 108 quality measures for breast and colorectal cancers that span the full range of cancer care, from diagnosis and staging, to initial management, coordination of care, and outcomes. NICCQ is evaluating the use of patient surveys and medical record reviews to assess performance on the quality measures. In particular, it is evaluating the ease and efficiency of identifying cohorts of patients, surveying them, and collecting their medical records while protecting their privacy. NICCQ is also evaluating the accessibility and reliability of the quality data from both sources, and the other steps necessary to establish an efficient and reliability real-time monitoring system. NICCQ is scheduled to complete work and report its results on quality of breast and colorectal cancer care as well as the monitoring system at the 2004 American Society of Clinical Oncology annual meeting. Performance feedback is just one method of improving quality. Other approaches include education, alignment of incentives, accountability, and decision support technologies. Until the infrastructure monitoring system is established, patterns of care studies such as the one presented by Movsas et al,8 and, in particular, repeated studies on the same topic to monitor trends, can give us some insight into where care needs to be improved on a population basis. AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST The authors indicated no potential conflicts of interest. REFERENCES 1. Lohr K: Medicare: A Strategy for Quality Assurance. Washington, DC, National Academy Press, 1990
2. McColl A, Roderick P, Gabbay J, et al: Performance indicators for primary care groups: An evidence based approach. BMJ 317:1354–1360, 1998 3. National Cancer Policy Board: Ensuring Quality Cancer Care. Washington, DC, National Academy Press, 1999 4. Donabedian A: Evaluating the quality of medical care. Milbank Mem Fund Q 44:166–203, 1966 5. Hillner BE, Smith TJ: The quality of cancer care: Does the literature support the rhetoric? Report to the National Cancer Policy Board. http://www.iom.edu/IOM/IOMHome.nsf/WFiles/mcvqual/$file/mcvqual.pdf 6. National Cancer Institute: Patterns of care in radiation oncology: RFA CA-94-006. NIH Guide 22: Number 40, 1993 7. Sugiyama H, Teshima T, Ohno Y, et al: The patterns of care study and regional cancer registry for non-small-cell lung cancer in Japan. Int J Radiat Oncol Biol Phys 56:1005–1012, 2003[CrossRef][Medline]
8. Movsas B, Moughan J, Komaki R, et al: Radiotherapy patterns of care study in lung carcinoma. J Clin Oncol 21:4553–4559, 2003 9. National Comprehensive Cancer Network: Oncology Practice Guidelines, version 3, 2003. http://www.nccn.org
10. Donabedian A: The quality of care: How can it be assessed? JAMA 260:1743–1748, 1988 11. Institute of Medicine NRC: Enhancing Data Systems to Improve the Quality of Cancer Care. Washington, DC, National Academy Press, 2000
12. Iezzoni LI: Assessing quality using administrative data. Ann Intern Med 127:666–674, 1997
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Copyright © 2003 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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