"Appropriate" diagnostic testing: supporting diagnostics with evidence-based medicine and shared decision making.

BACKGROUND: Evidence-based medicine is an important approach to avoiding care that is unlikely to benefit patients in both the treatment and the diagnostic context. The medical evidence alone may not determine the most appropriate care decision. Patient interests are best served when the advantages and risks of a diagnostic test are viewed through the lens of the patient's values. That is, the paradigm of evidence-based medicine should be complemented by the paradigm of shared decision making. ANALYSIS: Diagnostic testing may offer physiological and psychological benefits. Clinicians should also discuss the potential harms, however, which may be physiological (e.g. radiation or scarring), psychological (e.g. anxiety), and financial (e.g. cost-sharing burdens). All three of these concerns are compounded by the risk of false positives or incidental findings that are not serious, but which require decisions about further testing or treatment. CONCLUSION: We suggest that patient-centered decision making around diagnostic testing involves a two-step inquiry:(1) Is the test medically appropriate? Does the available evidence documenting short- and long-term risk and benefits support the test for its intended use, given the patient's characteristics and symptoms?(2) Is the test appropriate for this patient? Has the provider initiated a conversation about tradeoffs that helps the patient evaluate whether the balance of risks and benefits is consonant with the patient's own values and preferences? Potential benefits and harms to consider include the physiological, the psychological, and the financial.

Principles over principals? How innovation affects the agency relationship in medical and legal practice.

This Note outlines a conceptual framework for defining and analyzing innovation in the professional practice of medicine and law. The two professions have structural and historical similarities, and both are organized around the principal-agent relationship. Some types of professional activity adhere to the traditional agency model of principal-centered practice, but innovative professionals who develop novel tools and techniques often deviate from the agency model in interesting ways. This Note explores how that distinction plays out by identifying examples from academic medicine, public interest "cause lawyering", and corporate law. The field of medicine is governed by a regulatory regime that strictly differentiates routine practice from the experimental activities of clinical research, but the legal profession is governed by a monolithic code of conduct that does not explicitly acknowledge the types of innovation described here. Certain key events in the twentieth century help to explain why the government has chosen to tightly regulate innovation in medicine but not in law, and it turns out that innovators in both fields have found ways to stretch or bend the rules. These observations shed light on each profession's unique culture and can inform current debates over regulatory reform.

Prevalence and risk factors for periprosthetic fracture in older recipients of total hip replacement: a cohort study.

BACKGROUND: The growing utilization of total joint replacement will increase the frequency of its complications, including periprosthetic fracture. The prevalence and risk factors of periprosthetic fracture require further study, particularly over the course of long-term follow-up. The objective of this study was to estimate the prevalence and risk factors for periprosthetic fractures occurring in recipients of total hip replacement. METHODS: We identified Medicare beneficiaries who had elective primary total hip replacement (THR) for non-fracture diagnoses between July 1995 and June 1996. We followed them using Medicare Part A claims data through 2008. We used ICD-9 codes to identify periprosthetic femoral fractures occurring from 2006-2008. We used the incidence density method to calculate the annual incidence of these fractures and Cox proportional hazards models to identify risk factors for periprosthetic fracture. We also calculated the risk of hospitalization over the subsequent year. RESULTS: Of 58,521 Medicare beneficiaries who had elective primary THR between July 1995 and June 1996, 32,463 (55%) survived until January 2006. Of these, 215 (0.7%) developed a periprosthetic femoral fracture between 2006 and 2008. The annual incidence of periprosthetic fracture among these individuals was 26 per 10,000 person-years. In the Cox model, a greater risk of periprosthetic fracture was associated with having had a total knee replacement (HR 1.82, 95% CI 1.30, 2.55) or a revision total hip replacement (HR1.40, 95% CI 0.95, 2.07) between the primary THR and 2006. Compared to those without fractures, THR recipients who sustained periprosthetic femoral fracture had three-fold higher risk of hospitalization in the subsequent year (89% vs. 27%, p<0.0001). CONCLUSION: A decade after primary THR, periprosthetic fractures occur annually in 26 per 10,000 persons and are especially frequent in those with prior total knee or revision total hip replacements.