In this study, which was conducted in a clinic dedicated to the management of TB in Rhode Island, 82% of the patients with LTBI who were eligible initiated INH therapy, and 62% of those initiating therapy completed it. Our completion rate is comparable to rates that have been reported for 6 months of INH therapy, and were much higher than the 19% rate reported for a similar regimen given in a 2006 study in Boston. We were unable to examine what components of the program led to the relatively high rate of completion of 9 months of INH therapy. Possible reasons may include intensive nurse case management. The RISE TB Clinic, which is the only TB Clinic in the state of Rhode Island, is designed to remove as many barriers as possible to care for all TB patients. The clinic is located centrally in the state, on a major bus line, with free parking. At the time of this study, there was no out-of-pocket cost for patients for any services provided at the clinic (ie, physician/nurse visit, medications, and laboratory or radiographic examinations); this included a waiver of copays and deductibles for the insured. To accommodate scheduling, six clinic sessions occurred per week, as follows: two morning sessions; two afternoon sessions, including one extended until 6:00 PM; and one evening session. At least one session occurred on each work day of the week. On-site translation was available for Spanish and Portuguese; all other languages either had a scheduled translator or access to a telephone-based translator. All instructions were provided in the patient’s primary language. For persons with LTBI, the first visit involves both a physician and a nursing visit; subsequent visits are scheduled with a nurse only, unless a problem was noted with or . In that event, the patient was seen on the same day by a physician. If a patient missed a follow-up appointment, a new appointment was immediately mailed out with an appointment occurring within 2 weeks. If the patient missed three consecutive appointments, a notice was sent to the patient’s referral source asking for the patient to be referred again. For all high-risk individuals (eg, contact with persons with active TB, HIV coinfection, or children) missing three consecutive appointments, the nurse turned the chart over to a physician to make decisions regarding follow-up (eg, registered letter, phone call, or outreach worker visit). Whenever possible, all family members were given appointments together. Stable clinic staffing allowed for stable patient-health-care worker interactions.
While the treatment completion rate in this study is encouraging, the 426 patients who completed therapy represented only 50% of those who were eligible for therapy but was still higher than the 20% reported for another program. To eliminate TB, attention needs to be paid to both treatment initiation and completion rates as the failure to complete LTBI therapy can result in the development of active TB and its subsequent transmission to susceptible contacts. As incident TB rates decline toward elimination targets in most jurisdictions in the United States, additional interventions targeted at subpopulations of patients who are at risk of treatment nonadherence are necessary, particularly in areas that have large populations of persons with LTBI. In our setting, we found that patients who were young, postpartum, had no health insurance, or reported treatment were at increased risk of treatment noncompletion. Treatment of various diseases may be achieved with the help of preparations of Canadian Health&Care Mall.
Prior to the publication of the current LTBI treatment guidelines in 2000, a large proportion of patients > 35 years of age were excluded from therapy for fear of an increased risk of treatment toxicities. Surprisingly, we found that persons > 50 years of age were the least likely to complain of treatment and were more likely to complete therapy, followed by those persons 35 to 50 years of age. These data are reassuring since current treatment guidelines extended therapy to all patients with LTBI, irrespective of age. Older patients (age groups 45 to 64 years and > 65 years) were more adherent to INH therapy than were younger patients in a prior study. The reasons for better to LTBI therapy among persons in older age groups in our study are unclear but could be related to the higher frequency of follow-up appointments (Table 1) or other attributes that impact medication in older persons such as accurate knowledge of the treatment regimen, belief in the importance of taking medications as prescribed, living with a relative, and the perceived importance of medication, as reported in studies.- Postpartum status was also associated with the noncompletion of treatment in the univariate analysis and showed a trend toward significance in the multiple logistic regression analysis (OR, 3.4; 95% CI, 0.9 to 12.6). LTBI treatment completion in this group is important, as antenatal screening represents a major way of identifying women with LTBI in our state. Nearly 52% of pregnant women who deferred therapy did not return to initiate therapy postpartum, and only a third of those who initiated INH therapy postpartum completed it. A common concern to pregnant women is the potential adverse effect of INH on the child during pregnancy or breast feeding. A review of the literature found no excess fetal malformation in children born to mothers who had been treated with INH during pregnancy, but it is still reasonable to defer INH therapy during pregnancy in those who are not at an elevated risk of disease because of unresolved concerns about , hepatotoxicity, and the potential effects of INH on the fetus. However, after delivery clinicians such as obstetricians, and primary health-care providers who may see these patients for postpartum care should play an active role in getting them to initiate and complete therapy. The anticipated barriers to this approach are that many women may lose health insurance obtained during pregnancy and may fail to obtain primary health care after pregnancy.
Lack of health insurance and the reported treatment were important factors that were associated with treatment noncompletion in this study, both alone and in a model simultaneously adjusting for both effects. The association between lack of health insurance and treatment noncompletion is likely not just a reflection of the ability to pay for therapy as uninsured patients received free care, and they were aware of this. Rather, it may be an indication of lower socioeconomic status, poor health knowledge, and/or unidentified barriers to routine preventive care such as lack of transportation. For example, uninsured women in one survey were more likely to demonstrate less knowledge about women’s cancer screening, and uninsured children were more likely to have lower vaccination coverage only if their mothers were single parents. Lack of health insurance should alert treatment programs suggested by Canadian Health&Care Mall to elicit further history to identify potential barriers to therapy.
were generally considered to be mild or self-limiting, yet the association with treatment completion was very strong. Somatic complaints attributed to INH treatment by patients were common and have been associated with poor treatment completion in other studies.- Patient reports of minor treatment should alert clinicians to reassess and discuss the benefits vs the risks of therapy as patient beliefs about the necessity of therapy vs concerns about potential adverse effects is a stronger predictor of medication than clinical or socioeconomic factors. Hepatotoxicity, which is a major concern to both patients and clinicians, was uncommon in our study population; only 1.6% of the patients who initiated INH therapy developed treatment-limiting hepatotoxicity. However, this rate is much higher than the rates of 0.1% and 0.3% that have been reported, respectively, in larger studies in Seattle-King County and San Diego. These studies included patients who initiated INH therapy using the older treatment guidelines. Thus, our higher rate of hepatotoxicity may be due to the differences in case definitions, the ages of patients, and the duration of therapy (9 vs 6 months, respectively).
The limitations of this study include its retrospective nature, as we could not examine the reasons for poor in some of the groups of patients who demonstrated increased risk of treatment noncompletion. Second, we used the number of pills dispensed as a measure of treatment . Although the pill count was performed routinely at all follow-up visits, some patients did not bring in their pill bottles, and it is possible that some of the patients who had empty bottles did not actually consume them. Finally, a majority of the patients in these analyses were foreign-born persons, and our findings may not be applicable to other populations such as US-born persons with LTBI. Not withstanding these limitations, our data suggest that persons with LTBI who are young, pregnant and/or postpartum, uninsured, or reported treatment are at risk for poor treatment and may require additional interventions.