1. Pfeifer, Gail M. MA, RN

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In January 2006 the New York City Department of Health and Mental Hygiene (NYCDOH) mandated that laboratories testing serum glycosylated hemoglobin (HbAIc)- a value that determines the level of glycemic control in people with diabetes-must report the results to the department. The NYCDOH aims to use the laboratory values to improve public health surveillance of trends in glycemic control-a move the department hopes will lead to savings in lives and costs. Some critics have called the reporting requirement well intentioned but misguided, and diabetes specialists who were initially enthusiastic regarding efforts to improve diabetes outcomes have raised more questions about this approach.


Diabetes is the sixth leading cause of death in the United States. According to the Centers for Disease Control and Prevention (CDC), 7% of the population in the United States has diabetes, with 1.5 million new cases in people 20 years or older reported in 2005. The macrovascular and microvascular consequences of the disease, including heart disease, stroke, hypertension, blindness, kidney and nervous system diseases, and pregnancy complications, are devastating. Despite several studies that have highlighted the importance of glycemic control to prevent such complications, HbAIc levels have not been well controlled in most patients with diabetes. A 2004 review of data from the Third National Health and Nutrition Examination Survey (NHANES III, which ran from 1988 to 1994) and NHANES 1999-2000 showed that control of HbAIc levels, blood pressure, and total cholesterol-all risk factors for vascular disease-was achieved in only about 7% of the participants, with little change over the course of the two surveys. The term clinical inertia has been used to describe the failure of health care providers to intensify diabetes therapy when indicated.

FIGURE. New York Cit... - Click to enlarge in new windowFIGURE. New York City mayor Michael R. Bloomberg, center, health commissioner Dr. Thomas R. Frieden, right, and Dr. Peter Sheehan, president of the American Diabetes Association (ADA) New York City Leadership Council, unveil the ADA's New York City subway ad campaign "Are You at Risk?" in March. The new campaign comes on the heels of the city's controversial requirement that laboratories report serum glycosylated hemoglobin results in people with diabetes to the city's department of health.

The NYCDOH has declared diabetes an epidemic, with the number of New Yorkers afflicted estimated in 2003 at 530,000-9% of the city's population, 20% of adults over 65 years of age. It ranks as the city's fourth leading cause of death. Yet only 10% of New Yorkers with diabetes know their HbAIc levels.


Using public health tactics for a chronic disease.

Public health efforts to monitor disease, including surveillance, have typically focused on infectious disease and environmental threats to the public. How does monitoring diabetes fit into this framework? According to the Kaiser Health Policy Report, New York City's recent mandate marks the first time a health department has issued a reporting requirement for a noninfectious disease.


The new statute will allow the NYCDOH to develop a registry of reported HbAIc levels matched by patient and clinician. A quarterly roster stratified by glycemic control, daily alerts for HbAIc levels above 8%, and best practice recommendations will be sent to the clinicians. Patients with HbAIc levels above 8% will receive a letter with education and resource materials unless they opt out of the plan.


The main controversy: privacy.

One of the primary criticisms reported in the media has been the issue of privacy and the lack of prior consent. Reports to the NYCDOH will include personal identifiers such as birth date and place of residence and will match the patient to the health care provider. The NYCDOH has responded to this criticism by citing its success in holding confidential information on infectious diseases and disease registries in cancer, Alzheimer disease, immunization, and communicable diseases such as HIV for more than 100 years with no privacy breaches.


Both the ANA and the American Medical Association acknowledge in their codes of ethics that the rules of privacy are not absolute.


Also of concern is the issue of consent. Patients are not given the choice to participate in the program, although they may opt out of notification and intervention. The American Diabetes Association comes down clearly on the side of prior consent, stating in its July 2005 policy statement on diabetes registries for care and surveillance that such registries must contain a prior consent mechanism allowing each individual to opt in or out of such a registry before private information is distributed.


Many other U.S. registries that collect personal patient data for disease surveillance and tracking exist but have not drawn the fire NYCDOH's plan has.


"Registries are not new," says Ann Albright, PhD, RD, chief of California's diabetes program in the California Department of Health Services. What she says is unusual in the NYCDOH program registry is that "the tracking of data is not by the providers directly involved in patient care." Although the NYCDOH says it has safeguards to protect patient data, she points out that this type of tracking adds another layer of people who are exposed to the data, and mistakes can happen. In that case, she would like to know who will be there to assist these people.


Is there a next step?

The missing plan for what will be done with the collected data concerns Jane J. Seley, MSN, GNP, CDE, a diabetes nurse practitioner and certified diabetes educator (CDE) at New York-Presbyterian Hospital in New York City. Seley explains that there can be as much as a 2% variation in HbAIc results among laboratories. Seley is also concerned that few diabetes experts were consulted by the NYCDOH in the initial planning phase. Only one nurse was on the 10-member advisory board.


Linda M. Siminerio, PhD, RN, CDE, assistant professor at the University of Pittsburgh's School of Nursing and director of the university's diabetes institute, agrees. "It's critical that we start tracking and monitoring," says Siminerio, but "it's important that we are not exposing our patients to [more] challenges. We don't want people with diabetes to be blamed for not achieving goals." Siminerio emphasizes the importance of an infrastructure that's needed to achieve diabetes care goals, a method for evaluating interventions, and policies that will help pay for all of this, such as the statewide plan in progress in Pennsylvania.


The Pennsylvania initiative in addressing the diabetes epidemic gathered leaders from academia, health insurance organizations, public health, medicine, and nursing to form the Diabetes Stakeholder Group, which is developing a statewide blueprint to address diabetes care in Pennsylvania. The group identified the strategic components as surveillance, standards of care, policy, and evaluation. Will the surveillance plan follow NYCDOH's lead? Probably not, but they are taking a "wait and see approach," Siminerio says.


Continued planning.

Diana K. Berger, MD, medical director of the NYCDOH Diabetes Prevention and Control Program, acknowledges that data security is a valid concern but is confident in the safeguards the NYCDOH has in place and its 100-year history of no security breaches.


"All data are sensitive and important to someone," Berger says, and "very few people in the NYCDOH will have access to [these] data."


Surveillance is just the first step, according to Berger. "We are in the very early phase of designing this," she says. "What will we do with all these HbAIc levels?" Matching patients to clinicians is the first challenge; designing interventions and evaluations that will be meaningful for clinical and patient communities is next.