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Factors Important for the Selection of Key Patient Management Issues and Related Research Activities Hip fracture was selected for the Effectiveness Initiative research pro- gram because of its high concentration among elderly people and strong relationship to age; its high mortality, morbidity, and disability rates; con- siderable disagreement about surgical approaches in at least some classes of hip fracture; appreciable concern about whether the standard therapy surgery is appropriate in all cases (especially for patients whose prefrac- ture status was poor); wide variation in approaches to rehabilitation; and high costs of care that will increase in the future as the population ages. The committee agreed, in principle, that the HCFA data banks should be used to develop preliminary information on the costs and effectiveness of prevention, treatment, and rehabilitation of hip fracture. It also endorsed the general concept that analysis of variations in patterns of care and outcomes by geographic area, institution, type of provider or practitioner, and other factors could be a useful component of any effectiveness research program. Finally, it concluded that separate studies to determine the outcomes of care provided to the Medicare population will be valuable, especially if those analyses advance the understanding of the effectiveness of prevention strategies, Claris whether interventions offered to the elderly reduce the incidence of hip fracture at any given age, and identify preferred patient management regimens. SELECTING PATIENT MANAGEMENT ISSUES Several factors affect the selection of patient management issues for effectiveness research into hip fracture. Although not equally well docu- mented in the clinical or health policy literature, the committee believed 21
22 EFFECTIVENESS INITL24TIVE that all these factors deserved to be considered in choosing specific study topics: · epidemiologic aspects of hip fracture (e.g., the relative incidence of osteoporosis, falls, fractures, and repeat fractures in particular subgroups) · health status and quality-of-life aspects of both the illness itself and different treatment options for elderly people different treatment options characterized by the likelihood of pro- longing survival, producing major impairment and disability, or improving the patient's physical functioning and mobility, emotional well-being and social interaction, and independence · high degree of professional and clinical uncertainty or disagreement about alternative strategies for managing the care of hip fracture patients · substantial variation across geographic areas in the per-person use of services for hip fracture, including those for prevention and management of risk factors, beyond that explained by differences in patient characteristics or health resources · substantial variation across geographic areas or institutions in the outcomes of care for patients with hip fractures, beyond that explained by the differences in the severity or type of fracture or the sociodemographic characteristics of patients · relatively high costs to the Medicare program for the services to prevent hip fractures and to treat and rehabilitate hip fracture patients · relatively high out-of-pocket costs to Medicare beneficiaries for hip fracture prevention, treatment, and follow-up care. SELECTING RESEARCH TOPICS AND ACTIVITIES Content, Conduct, and Use of Research For high priority hip fracture research, the committee raised three additional points. First, it endorsed four generic subjects identified by the October 1988 workshop: prevention, generation and use of outcomes measures that include functional status and quality of life, analysis of men- tal and emotional dimensions of an illness (cognitive functioning, anxiety and depression), and clarification of the difference between efficacy and effectiveness. Second, the research strategy adopted should be the one that is most appropriate for the specific question being asked. For effective- ness research, the choice of strategies include monitoring through analy- sis of administrative data; observational (cross-sectional, case-control, or longitudinal-cohort) studies; quasi-experimental studies and demonstra- tions; and, potentially, Reins. The choice is often determined by the research question, but if the question can be addressed by more than one
HIP FIUCTURE 23 approach, then the complexity, rigor, and expense of alternative research designs should be examined. Plans to use more than one strategy either simultaneously or sequentially should also be considered. In addition, projects based on newer, more sophisticated, nonexper- imental techniques, such as meta-analysis and cost-effectiveness analysis, should be included among the research options. Furthermore, the Medi- care claims databases might yield information that is useful for developing decision-analytic methods (which incorporate data-based probabilities). In short, the committee concurred that all these approaches should be con- sidered potential investigational methods for effectiveness research and cautions that there is no single appropriate strategy. The committee also wishes to emphasize the importance of evaluating beforehand the trade-off; implicit in selecting one approach over another and in mounting combined approaches. Third, the committee stressed the contributions that studies of partic- ular illnesses can have as prototypes for examining other conditions. Hip fracture research should be seen as an opportunity to address conceptual and methodologic issues relevant to other conditions or functional im- pairments that are prevalent in the Medicare population and that call for attention to prevention, rehabilitation, or situations in which standard ther- apy (e.g., surgery in a patient who suffers from dementia or is bedridden) may not be in that patient's best interest. Data Issues The October 19~ worl~;hop committee questioned the adequacy and availability of data to investigate key effectiveness questions through HCFA's existing (or anticipated) administrative data files. As effectiveness research proposals depend on the quality of the data collected and used, the hip fracture committee reiterated this general concern with respect to hip fracture. First, adequate data on health and functional status of patients with hip fracture must be available before any longitudinal studies of alternative therapies (surgical and rehabilitative) are undertaken with the Medicare files. Second, accurate case identification and coding must be assured. Problems with the Medicare files include inaccurate descriptions of race, discrepancies in numbers of identifiable cases based on diagnosis versus those derived by summing over appropriate procedures, inability to identify reliably the type or stage of fracture, and inability to differentiate left from right hip fracture (meaning that it is also difficult to distinguish a reoperation on one hip from a first operation on the other). 1b the extent that information about hip fracture from the administrative data
24 EFFECTIVENESS INITLi4TIVE bases lacks reliability and validity, data analysis and interpretation will be severely restricted; this limitation must be acknowledged and overcome. Third, extensive and high quality data are necessary for the analysis of comorbidity (or case mix). Analyses of hip fracture, for instance, should not combine (or confuse) patients who were healthy before the fracture with those for whom the fracture is a culmination of numerous chronic conditions. Adequate case mix data are needed-both for interpreting prac- tice variations and, more critically, for investigating outcomes (especially those with strong quality-of-life components). Notwithstanding the above caveats, the committee endorsed the view that the existing administrative data sets even now can provide information on several important topics, such as the site of service, shifts in the choice of procedures over time (e.g., from pinning to total hip replacement), and geographic variations in broad patterns of care. They can also be used to evaluate in-hospital survival, time-based survival (30 days, six months, one year), readmissions, some complications, and other simple outcome measures. Thus, although the discussion emphasized the necessity of obtaining richer clinical and patient outcome data through, for instance, Medicare PROs or primary data collection, the potential of the existing data sets to answer some questions was acknowledged.
