Not every TB patient needs directly observed therapy to comply

Case management is critical component

When the incidence of tuberculosis increased in the early 1990s, the threat of multidrug-resistant strains was limited with directly observed therapy (DOT) - a program in which a public health care worker actually watches a patient take each dose of medicine. Yet a new study published in the July issue of the American Journal of Public Health calls for re-examination of this standard of care, in which all people diagnosed with TB - regardless of socioeconomic status - receive DOT.

The initial push for widespread use of DOT was based on the fact that many TB patients, especially those on the margins of society, fail to take their medicine properly during the six-month course of treatment. Failure to adhere to the drug regimen can lead to the emergence of multidrug resistant strains of Mycobacterium tuberculosis. In fact, in 1996, the Centers for Disease Control and Prevention recommended that universal DOT be considered in all places where treatment completion rates fell below 90%.

The current study is the first to examine the relationship between DOT rates and completion rates in 25 cities or counties with 100 or more newly diagnosed TB cases from 1990 to 1994, the period in which universal DOT became a national policy.

"Our conclusion was that a one-size-fits-all approach is not necessarily the most cost-effective method for TB control," says co-author Ronald Bayer, PhD, professor at the Columbia School of Public Health in New York City.

The study found that in areas with high treatment completion rates, increasing DOT use had only marginal effects.

The study also found that treatment rates can rise without universal DOT. For example, New York City's treatment completion rate rose from less than 60% in 1990 to 89% in 1994, but only slightly more than one-third of TB patients were on DOT, Bayer says.

Yet Bayer does not diminish the use of supervised therapy. "It clearly plays an important role in improvement," he says. For example, the study found that in places with historically low treatment completion rates, the increased use of DOT led to radical improvements, he says.

But Bayer stresses that careful surveillance, case management, adequate training of committed caregivers and "administrative rigor on treatment completion rates" play an equally vital role in combating the disease.

"In cities where the TB control program or public health infrastructure is in disarray, formal increases in DOT do not result in improvements in treatment completion," he says.

For example, despite an increase in DOT in Washington, DC, treatment completion rates actually declined.

Teamwork key to fighting TB

Bayer also points out that, even within a given city, all DOT programs are not equally effective. "Much depends on the quality of the staff, the skill with which it is managed, and the capacity to establish ongoing relationships with patients," he says.

For example, in 1994, The New Jersey Medical School National Tuberculosis Center began integrating clinical and outreach functions of TB control by using a team approach that features case management as the cornerstone.

"We found that this case management component is vital," says Lee B. Reichman, MD, MPH, executive director, who attributes this approach in "turning the tide of TB in Newark."

The team includes a nurse, who serves as case manager and team leader, a physician who directs changes in medication and reviews lab reports, an LPN who gives injectable drugs, the TB control officer for the county, and two levels of outreach workers. The first conducts first investigations and the second delivers DOT.

However, case managers aren't merely paper pushers. "They also go into the field," stresses Bonita T. Mangura, MD, the center's clinical studies director.

Four such teams serve Newark, which is divided into wards according to ZIP codes, she says. "We match the ethnic background of our outreach workers with the culture that is more predominant in that area," she explains. "For effective TB treatment, you must not only provide services, but do so with an understanding of another's culture."

Being willing to go the extra mile - literally - can also mean the difference between DOT success and failure. "We call it 'shoe leather delivery,'" says Mangura. "The workers go to no-police zones - places the police won't enter," she says.

Then there's the team's ability to problem-solve, facilitate, and empathize with patients, especially indigent ones. "You have to establish rapport and trust. If you treat them in a condescending manner, it will create discomfort and lead to treatment obstacles," she says.

Team members often brainstorm solutions to patients' problems that are not directly related to DOT. "If you're homeless, the last thing on your mind is taking your TB medicine," she says.

For more information, contact:

· Ronald Bayer, 600 West 168th St., New York, NY 10032.

· Lee Reichman, The New Jersey Medical School National Tuberculosis Center, 65 Bergen St., Newark, NJ 07107-3001. Telephone: (973) 972-3270. Information Line: (800) 4TB-DOCS.