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I.

Clinical Question:

What are the effects of simultaneous use of highly active antiretroviral Therapy on the rate of survival of HIV Patients with Tuberculosis?

II. Citation:
Effect of Simultaneous Use of Highly Active Antiretroviral Therapy on Survival of HIV Patients with Tuberculosis

III.Study Characteristics 1. Patients included:


The study selected all HIV patients included in the COMESEM cohort with TB diagnosis after 1996. Clinical and epidemiological data were registered. 6934 HIV patients were included in the cohort. COMESEM cohort comprises demographic and clinical data of all HIV-infected adult patients attended in 5 population-based hospitals in Madrid during more than 20 years (from 1984). The cohort was prospectively constituted in 2000; data before this date (since 1984-2000) were retrospectively collected. The study selected all patients included in the cohort with a diagnosis of TB of any kind from 1987 until 2004. To assess the effect of HAART on the survival of patients with TB and to avoid the bias of antiretroviral potency, the study analyzed the patients with TB diagnosed after 1996.

2. Interventions compared:
The interventions compared were the use of HAART treatment of patients at the diagnosis of TB (simultaneous therapy) or not.

3. Outcomes monitored:
The outcomes monitored were the survival rate of patients diagnosed with TB who started HAART early, specifically the mortality rate. Also, the effectiveness of the said drugs was also included in the study.

4. Does the study focus on a significant problem in clinical practice?


Yes the study focuses on a significant problem because upon starting with HIV which is predominantly considered as one of the factors that predisposes you in an increase risk for having tuberculosis which stands as one of the leading causes of mortality in the population. This is a leading cause of mortality and morbidity that causes bodily symptoms that alters the patients immunologic status thereby predisposing the patient to acquiring more infections and later on if not treated leads the patient to demise in a relatively short period of time due to the complications of the disease. Therefore through this we would be able to determine which specific intervention should be performed in treating patients who have been diagnosed with tuberculosis and also maximizing the use of HAART.

I. Methodology/Design 1. Methodology used:


The study included all the HIV patients included in the COMESEM cohort with TB diagnosis after 1996. Clinical and epidemiological data were registered. We compared patients who started HAART at the diagnosis of TB [simultaneous therapy (ST)] or not. Survival was assessed by Cox analysis (SPSS). 2. Design: All the HIV patients included in the COMESEM cohort with TB diagnosis after 1996 were selected as subjects of the study. Then their clinical and epidemiological data were registered. Then we compared patients who started HAART at the diagnosis of TB [simultaneous therapy (ST)] or not. Then the survival rate was assessed by Cox analysis. The treatment includes HAART (Highly active antiretroviral treatment through the use of different drugs such as AZT. 3. Setting: The study took place in 5 population-based hospitals in Madrid, Spain. 4. Data sources: Lawn SD, Myer L, Bekker LG, et al. Tuberculosis-associated immune reconstitution disease: incidence, risk factors and impact in an antiretroviral treatment service in South Africa. AIDS. 2007;21:335-341. Dean GL, Edwards SG, Ives NJ, et al. Treatment of tuberculosis in HIV-infected persons in the era of highly active antiretroviral therapy. AIDS. 2002;16:75-83. Kwara A, Carter EJ, Rich JD, et al. Development of opportunistic infections after diagnosis of active tuberculosis in HIV-infected patients. AIDS Patient Care STDS. 2004;18:341-347. Breen RA, Smith CJ, Cropley I, et al. Does immune reconstitution syndrome promote active tuberculosis in patients receiving highly active antiretroviral therapy? AIDS. 2005;19:1201-1206. Blanc FX, Havlir DV, Onyebujoh PC, et al. Treatment strategies for HIV-infected patients with tuberculosis: ongoing and planned clinical trials. J Infect Dis. 2007;196:S46-S51. Castilla V, Alberdi JC, Barros C, et al. Cohorte multicentrica de pacientes con infeccion VIH de la corona metropolitana sudeste de Madrid (COMESEM): fundamentos, organizacion y resultados iniciales. Rev Clin Esp. 2003;203:170-177. Couzigou C, Semaille C, Strat YL, et al. Differential improvement in survival among patients with AIDS after the introduction of HAART. AIDS Care. 2007;19:523-531.

Nahid P, Gonzalez LC, Rudoy I, et al. Treatment outcomes of patients with HIV and Tuberculosis. Am J Respir Crit Care Med. 2007;175:1199-1206. Lawn SD, Wood R. Incidence of tuberculosis during highly active antiretroviral therapy in high-income and low-income countries. Clin Infect Dis. 2005;41:17831786. Manosuthi W, Chottanapand S, Thongyen S, et al. Survival rate and risk factors of mortality among HIV/tuberculosis-coinfected patients with and without antiretroviral therapy. J Acquir Immune Defic Syndr. 2006;43:42-46. Dheda K, Lampe FC, Johnson MA, et al. Outcome of HIV-associated tuberculosis in the era of highly active antiretroviral therapy. J Infect Dis. 2004;190:1670-1676.

5. Subject selection a. Inclusion criteria:


The study selected all patients included in the cohort with a diagnosis of TB of any kind from 1987 until 2004. To assess the effect of HAART on the survival of patients with TB and to avoid the bias of antiretroviral potency, we analyzed the patients with TB diagnosed after 1996. b. Exclusion criteria: Patients diagnosed of TB before the year 1996 were excluded from the study. Patients receiving HAART for more than 2 months before the diagnosis of TB were also excluded from the study.

1. Has the original study been replicated?


Yes, the study has been replicated. It indicated that a recent preliminary report has also described a higher mortality rate in patients who did not start HAART and TB treatment at the same time.] Given the fact that results from clinical trials are pending, data from studies with a lower level of evidence (such cohort studies) are a very important source of information, as they are the best evidence available. In the same way, other authors have emphasized the good evolution of patients with concomitant TB treatment and HAART, yet without data about mortality. Hung et al showed a similar virological, immunological, and clinical response of treated patients for TB and HIV than patients without TB (who received only HAART). In addition, HAART may have beneficial effects in the evolution of TB as it was stated by Nahid et al. They found that use of HAART during TB treatment was associated with more rapid conversion of smears and cultures and improved survival. In addition, none of the patients in this study who received concomitant HAART relapsed.

2. What were the risks and benefits of the nursing action/intervention tested in the study?
The study did not provide information about side effects or interactions of drugs or about immune reconstitution inflammatory syndrome (IRIS). The end point of the study, death, is hard enough to prevail over less relevant complications such as side effects not affecting survival. The benefit of the study that the specified intervention has caused decreased mortality.

I. Results of the Study


Among the 6934 HIV patients included in the cohort, 1217 patients had at least 1 episode of TB (17.6%), and there were 322 (26.5%) patients with TB in the period after 1996. Nine of them were receiving HAART for more than 2 months at the moment of diagnosis of TB and were excluded from the study. Patients with TB after 1996 were 80% male and mean age was 34.9 years (SD 7.5). Endovenous drug use was the most common risk group (75%). Extrapulmonary TB was diagnosed in 67.4%. Other simultaneous AIDS-defining conditions were present in 15% of cases. CD4 lymphocyte count at diagnosis of TB did not vary with time [mean 210 (193), median 160 (IQR 69-289)]. Viral load at the TB diagnosis was 4.7 log copies per milliliter (SD 1.6), median 5.0 (IQR 4.0-5.7). HIV and TB infections were diagnosed in the same year in the 37.4% of patients and in following 3 years in the 60% of cases. These data did not change significantly with time, although there was a tendency to a later diagnosis of TB (3 years) in the last 5 years. Fortyseven patients (15%) died during the follow-up. Forty-five percent of patients (n = 140) received HAART at the time of TB diagnosis. There were no differences between those who started HAART at the diagnosis of TB or not regarding age, sex, risk practice for HIV infection, being immigrant, CD4 count at diagnosis of TB, presence of other AIDS-defining illnesses, and in the proportion of extrapulmonary TB ( Table 1 ). However, viral load was somewhat lower in patients who started TB treatment and HAART simultaneously [median viral load 4.8 (IQR 3.3-5.7) versus 5.1 log copies per milliliter (IQR 4.7-5.9), P = 0.011]. At the end of follow-up, there were no significant differences in CD4 cell count, viral load, or the number of antiretroviral drugs used (3 both groups) between patients who started HAART at the diagnosis of TB or not ( Table 1 ). Age, sex, extrapulmonary TB, and CD4 cell count and viral load at the moment of diagnosis of TB were not significantly different in patients who died ( Table 2 ). In contrast, patients who died were more likely to be drug users, had an earlier year of diagnosis of both TB and HIV infection, had another AIDS-defining condition, and received nonsimultaneous TB-HIV treatment ( Table 2 ). However, by univariate Cox analysis, being drug users, year of diagnosis of TB, other AIDS-defining conditions, and nonsimultaneous treatment were the only significant (or nearly significant) variables associated with poor survival ( Table 3 ). In Cox univariate analysis, simultaneous treatment was associated with a markedly improved survival [hazard ratio (HR) 0.38; 95% confidence interval (CI) 0.20 to 0.72, P = 0.003], ( Fig. 1). In a

multivariate analysis including all nearly significant variables (P < 0.1), simultaneous treatment remained as a powerful predictor of survival (HR 0.35; 95% CI 0.18 to 0.67, P = 0.001). Finally, after further adjusting for age, sex, CD4 cell count, and log viral load at the moment of TB diagnosis, the association of simultaneous treatment with survival remained essentially unchanged (HR 0.37; 95% CI 0.17 to 0.66, P = 0.001). Interestingly, a dramatic survival advantage was evident in the short term (Fig. 1). At 6 months of follow-up, HR for simultaneous use of TB-HAART was 0.15 (95% CI 0.03 to 0.586, P = 0.007). This survival effect was attenuated at 12 months (HR 0.33; 95% CI 0.14 to 0.78) and was maintained in a similar HR until the end of follow-up.

II. Authors Conclusions/Recommendations 1. What contribution to client health status does the nursing action/intervention make?
The simultaneous use of HAART and TB treatment in HIV patients with TB is associated with improved survival rates. Thus, help prolong the lifespan of the client.

2. What overall contribution to nursing knowledge does the study make?


The study implies that the use of simultaneous treatment in combination with the antituberculosis medications results to higher chances of survival of the patient.

I. Applicability 1. Does the study provide a direct enough answer to your clinical question in terms of type of patients, intervention and outcome?
For me, the study provided a direct answer to my clinical question. This is because the research monitored the clients carefully. The study had good criteria in selecting participants in the research process. The study had more credibility because its not limited to a few number of patients. It was also strengthen with the use of statistical tests and measurement in proving the significance of the results.

2. Is it feasible to carry out the nursing action in the real world?


For me, the study is feasible enough to be carried out to the nursing world, especially in our country; considering the fact, that Tuberculosis is included in the top illnesses that causes mortality. In addition, this study will be useful enough in providing care for the HIV positive clients who develop the TB complications. In this way, the benefits of the study will aid Filipinos in achieving a higher mortality survival rate as well as maximizing the effect of the medications.

I.

Reviewers conclusion/commentary

The study does not have data about side effects or interactions of drugs or about immune reconstitution inflammatory syndrome (IRIS). The end point of the study, death, is hard enough to prevail over less relevant complications such as side effects not affecting survival. The effect of physician preference for starting HAART may be a source of bias. Patients with suspected better adherence and lower probability of side effects could have been selected to start simultaneous treatment. Some variables to identify these patients such as other comorbidities or adherence are unknown in our study. Causes of death were not included. NonHIV related causes of death might change the conclusion of the study. Several works about mortality showed a shift in the causes of death toward 2000-2003 In summary, the findings suggest improved survival by using concomitant TB therapy and HAART that seems independent of other classical factors such as CD4 count. Further research should be done to identify the optimal time for HAART in the treatment of HIV-related TB.

II. Evaluating nursing care practices a. Safety:


Though the study involves the use of HAART which poses some harm to the patients even so this study is still considered safe. b. Competence of the care provider: Proper knowledge on carrying out the treatment, having knowledge about the side effects, drug interactions and careful monitoring of the side effects of the drugs involved in HAART are the competencies that nurse should acquire in order to be competent enough to carry out this nursing practice. c. Acceptability: The intervention is widely accepted in the Philippines because there are no barriers such as religious and cultural practices and restrictions that would inhibit people from utilizing the HAART as an effective way of prolonging lifespan of HIV patients with TB. Though there might be financial constraints on the part of the patient regarding the drugs to be administered still this can still be considered highly acceptable. d. Effectiveness: Based on the results that have been seen in the study, simultaneous HAART and TB treatment in HIV patients with TB is associated with higher survival rate which only proves it to be effective. e. Appropriateness: The intervention of giving simultaneous HAART and TB treatment is appropriate in the situation because this corresponds to the clients HIV and TB and then improves the clients condition thereby also prolongs lifespan of patients with both HIV and TB.

f. Accessibility: The intervention of giving simultaneous HAART and TB treatment can be considered readily accessible because nowadays there have government projects that have been offering medications for the treatment of both the TB and HIV.