Universal or not? Top programs respond

Some do fine with selective DOT, thank you

After a four-year campaign, directly observed therapy (DOT) has become an accepted practice in most TB programs. Where experts split, or at least differ in varying degrees, is in whether they believe a policy of DOT for all is best, and whether implementing universal DOT would improve their already notably successful programs.

TB Monitor set out to find where good TB control programs stood on the issue by conducting an informal telephone survey in November. The TB controllers surveyed are the heads of programs in the 10 states where 90% or more of all active TB cases completed their therapy within 12 months or less, according to a study of aggregate data from 1992 that was released last year by the Centers for Disease Control and Prevention in Atlanta.

The 10 states’ TB controllers were asked to describe how big a role DOT played in their TB control programs. They were also asked whether they hoped eventually to enroll all their patients in DOT, increase the proportion getting DOT, or keep the level about the same.

Of the 10 states in the nation with the best completion-of-therapy rates, five have a high proportion — between 75% and 100% — of tuberculosis cases on DOT. In the other five states, DOT plays what might be described as a supporting role, with the proportion of TB patients who are on DOT ranging from 30% to 53%

Certainly, no one in any of the 10 states disputes the value of DOT for some patients. Saying you’re for DOT is "like saying you support apple pie and motherhood," notes Jim Jones, MPH, TB controller of North Carolina.

Perhaps not surprisingly, program heads in the five states that already have high rates of DOT — namely, Alabama, Maryland, Colorado, South Dakota, and Mississippi — profess enthusiasm about increasing the amount of DOT; likewise, more say their ultimate goal is to achieve universal DOT.

In the other five states — Wyoming, Tennessee, North Carolina, Connecticut, and New Mexico — some program directors are satisfied with relatively low rates of patients on DOT; others express disagreement, or at least are skeptical of, the notion that everyone should get DOT.

Two big cities where TB controllers were also surveyed mirrored the same pair of attitudes on the subject. In New York City, TB controller Paula Fujiwara, MD, says that she’d like to see all the city’s TB cases on DOT; in Los Angeles, TB controller Paul Davidson, MD, says he is happy with his mix of DOT and self-administration — though he would like to increase the proportion of cases on DOT to about 50%.

Reasons why some programs aim for universal DOT and other don’t are somewhat predictable, but not entirely.

Those who favor lots of DOT and wish they were universal cite decreasing rates of acquired resistance, coupled with increased patient and worker satisfaction. Only one person, Mike Holcombe, MPH, TB controller for Mississippi, mentioned cost as an incentive for universal DOT, commenting that "it may not be cheaper in the short run, but in the long run it certainly is."

Reasons why other programs aren’t setting their compasses for universal DOT are more varied.

With less than half of North Carolina’s cases on DOT, Jones explains that his success with relatively low rates of DOT makes it tough to argue for increased resources to do more DOT.

Other directors cite the possibility of annoying or alienating patients; they say they’ve reached a point of diminishing returns or their scant resources are already stretched thin across wide-open spaces.

State by state, here’s what people in the U.S. are saying about the subject of universal DOT:

Alabama: With about 90% of his TB cases already on DOT, TB controller Frank Bruce, MD, still likes to leave the door open for some selectivity, he says, and doesn’t plan on moving the state any farther toward universal DOT.

Strangely, some patients actually appear to be developing drug resistance, even though, because they are getting DOT, there’s absolutely no question as to whether they’re taking their meds, Bruce notes. Looking at data from three states (including Alabama), Nancy Dunlap, MD, medical consultant to the state’s TB control program, has found that TB drugs are present in some patients’ blood in sub-therapeutic levels.

Dunlap’s findings notwithstanding, Bruce describes himself as a firm believer in the value of DOT. "But I do think you need a little [flexibility] on some occasions," he says.

Colorado: With outspoken proponents of universal DOT encamped in Denver, it doesn’t take a rocket scientist to predict where this state stands on the subject. Colorado has 95% of cases on DOT, and is shooting for 100%, says Barbara Hummel, RN, CIC, BSN, public health nurses consultant for the state’s TB program. "I believe in universal DOT," she says. "There’s no reliable information" that predicts adherence, she says, echoing a theme commonly mentioned by those who promote universal DOT.

The state tries to be as creative as possible in finding ways to get people on DOT, she says. "We make home visits, help pay for visiting nurses to go to the home, and give bus tokens and gift certificates," she says, and even throws "completion parties" for patients who have finished their DOT-administered therapy.

Connecticut: With only five outreach workers assigned to cover the state, slightly more than half of Connecticut’s TB cases are on DOT, says TB controller Joe Marino. Although the completion-of-therapy rate is 95%, he’d like to raise the percentage of cases on DOT to "between 60% and 70%," he adds.

Marino attributes his state’s good completion rate to two things: a recently passed state law that allows health departments to force nonadherent patients to undergo DOT; and an emphasis on "individual accountability" that guarantees that some individual is responsible for every patient completing therapy, whether by means of DOT or not.

Though limited resources mean he can’t shoot for 100% DOT, more DOT is still a worthy goal, Marino says, "because the more therapy you get in a shorter period of time, the better off you are."

Maryland: Maryland calls itself a "universal" state, and with 82% of patients on DOT, that’s more than wishful thinking but less than technically correct.

‘We’ve got 24 local fiefdoms’

The gap exists because "we’re still persuading" the remaining 18%, says Sarah Burr, RN, MPH, the state chief of TB control. Burr explains: "In Mississippi, the state TB control department is the local department. They can say, ‘Thou shalt do X,’ and X gets done." In Maryland, on the other hand, the state office can’t dictate policy. "Instead," says Burr, "we’ve got 24 local fiefdoms that do whatever they want."

To help whip the counties into line, Burr has two weapons at her command: education ("We’ve said DOT is the standard of care till we’re blue in the face") and data "report cards" for each county that let the state’s 24 counties see how each other is doing.

The state’s 98% completion rate is also helped by the fact that Maryland leads the nation for numbers of patients started on four-drug therapy.

The only downside to the picture is lingering resistance among outreach workers to the notion of universal DOT. "[Some] still find it intrusive," Burr says. "Me, I can’t get through five days of antibiotics — I’m a complete believer."

Mississippi: The state became the first in the nation to go to universal DOT in 1985, and Mike Holcombe, state TB controller, professes no regrets. Before universal DOT, "we had a very high rate of drug resistance, a lot of it acquired; lots of patients not taking their meds; and lots of people on extended therapy," he says.

The state tried universal DOT in a pilot program, and the results spoke for themselves, Holcombe says.The pilot patients on DOT got better faster than patients on self-administered therapy, he says. In addition, making the protocol universal seemed to please patients and staff alike, he says. "With self-administered therapy, there are too many chances to overlook things."

New Mexico: Thirty-four percent of TB cases were placed on DOT in 1995, says Doris Fields, MA, state TB controller. That’s plenty for David Simpson, MD, PhD, MPH, the medical director for infectious diseases in the state’s Department of Health.

"I’ve always found the DOT maxim a little oppressive and a little paternalistic," says Simpson. "I find only having one way of doing things particularly offensive. Public health sometimes suffers from trying to put everything into dogma. We try to avoid words like ‘protocol,’ and prefer ‘guidelines.’"

The state is extremely diverse ethnically and racially says Simpson, and lends itself well to a tailored approach to issues of therapy completion. "We try to treat each case so people can claim ownership for [their finishing treatment]," he says.

Simpson credits the state’s high marks in completion partly to a good infrastructure left over from the days when the state was a mecca for TB patients. TB was a growth industry that has left New Mexico blessed with a good infrastructure and dedicated public-health nurses in virtually every far-flung hamlet and isolated village, Simpson says.

North Carolina: Fifty-three percent of TB cases are on DOT now, a figure Jim Jones, MPH, TB branch chief would like to ratchet up to about 75% to 85%. "Based on data from other states, we’re not certain you can keep a much higher percentage on DOT than that," he says. "We think you reach a point of diminishing returns."

Provider must believe in DOT

Jones says the key to successful DOT is for the worker who gives it to be positive, not regard it as a punishment. "The health care provider needs to believe in DOT," he says. "That’s the single biggest key."

Though he feels 100% DOT may not be achievable, Jones says he subscribes to one of the rationales offered in its support — the inability to predict adherence. "You have plenty of doctors, nurses, schoolteachers, and lawyers you cannot rely upon to take their meds," he says.

South Dakota: With 76% of cases on DOT, Kristin Rounds, the state TB controller, says she’d like to have 100%. "We’d even like to have everyone on DOPT [directly observed preventive therapy]," she adds, referring to preventive therapy for infected patients. "We’re a little over-eager."

Despite the fact that the state is huge, with only scant resources to cover its sparsely populated area, Rounds attributes her good completion-of-therapy rate to the way TB cases are restricted to several manageable clusters in specific geographic locations.

Those spots, which Rounds targets with outreach-worker programs, include a couple of Native American reservations, and Sioux Falls, the state’s biggest city, where foreign-born patients account for most of the cases.

A pair of oddities appear to account for the state’s notably low rates of drug resistance. First, it’s state policy to provide DOT to all foreign-born cases — not because they’re a bad risk for adherence, Rounds says, but to make absolutely certain they don’t import drug resistance into the state.

By comparison, many locales that have adopted a strong philosophical stance against universal DOT do so partly because they find the foreign-born to be reliable med-takers, and they would only be inconvenienced — or frightened into "going underground" — if they were instructed to take DOT. (See related story in TB Monitor, December 1996, p. 136.)

The second factor behind the state’s low rate of resistance is the fact that when Native Americans fail to take their meds, they do so across the board, not selectively, Rounds says. "They’re so bad about compliance, they don’t take sporadic meds — instead, they just don’t take ‘em at all," she says. "As far as resistance goes, that’s to our benefit."

Tennessee: Here, the proportion of patients on DOT stands at about 45%, says state TB controller Dave Crowder. Even though he’d like to see more patients at risk for nonadherence on DOT, Crowder says he finds it hard to make the argument for the extra money needed to push Tennessee toward universal DOT.

"We’ve got little if any acquired drug resistance, and we’ve got high rates of completion. So when you go to make the case for universal, they look at you and say, ‘Uh, well. . . .’"

He doesn’t find it terribly difficult to predict which patients will need DOT and which won’t, Crowder adds. Indeed, one reason the state program is in such good shape is that many TB cases occur among the elderly, who "tend to be more compliant."

So do people in rural areas, where less DOT is used, he adds. By comparison, in urban areas like Nashville, more people fall into high-risk categories for nonadherence; there, too, more patients are on DOT.

Wyoming: Of the six to 12 cases of TB identified for each of the past three years, about 37% got placed on DOT, says Alex Bowler, MPH, CHE, state TB controller. "We plan to increase the percentage, and I’ve love to have everyone on DOT — but frankly, we just don’t need it," he says. "Most of our patients are older white people with reactivation TB, and they’re highly motivated to get well."

Los Angeles: Here, about 30% of all TB cases are on DOT; and Paul Davidson, MD, the city’s TB controller, is aiming at 50%. "I can’t say our goal should be 100%," says Davidson. "Nor do we have that great a problem in completion of treatment." Furthermore, patients who are apt to be compliant "find [being placed on DOT] offensive," Davidson says.

New York City: In 1995, about 1,300 patients were receiving DOT, and there were 2,995 active cases, says Paula Fujiwara, MD, city TB controller. (She cautions that because two different counting methods are used, the "numerator and the denominator don’t match" for the two sets of figures.)

Despite the fact that her numbers resemble those in L.A., she comes down on the subject of universal DOT completely differently. "I think the goal of a program should be to put everyone on universal DOT," she says.

Lacking the infrastructure to do so right now, Fujiwara says the program has established as its top priority for DOT those patients who are HIV-positive patients, followed by those who are smear-positive. The lowest priority are patients with extrapulmonary TB, she says.

Special Report: Directly Observed Therapy