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 Table of Contents  
ORIGINAL ARTICLE
Year : 2021  |  Volume : 10  |  Issue : 3  |  Page : 285-292

The effect of collaborative care on treatment outcomes of newly diagnosed tuberculosis patients with Type-2 diabetes mellitus and adverse drug reaction presentations: A prospective study


Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Lagos, Lagos, Nigeria

Date of Submission02-Jun-2021
Date of Acceptance10-Jul-2021
Date of Web Publication3-Sep-2021

Correspondence Address:
Foluke Adenike Ayeni
Department of Clinical Pharmacy and Biopharmacy, Faculty of Pharmacy, University of Lagos, Lagos
Nigeria
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Source of Support: None, Conflict of Interest: None


DOI: 10.4103/ijmy.ijmy_124_21

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  Abstract 


Background: The burdens of tuberculosis (TB) and diabetes mellitus (DM) in Nigeria are high. DM often goes unrecognized in TB patients, resulting in poorer treatment outcomes compared with TB patients only. This study set out to compare TB treatment outcomes and associated factors in TB only and TBDM patients when a collaborative care (CC) model is in place. Methods: A prospective quasi-experimental study, modeled after the World Health Organization and The Union's Collaborative Framework for Care and Control of TB and DM was carried out among TB patients in two chest clinics in Lagos state. Patients were grouped into TB only, who received the usual TB care, directly observed treatment, short course (DOTS), and TBDM, who received DOTS and CC. Data were analyzed with IBM Statistical Package for the Social Sciences, version 23.0. Chi-square and multivariate analysis determined the association between treatment success and CC. Statistical tests were calculated at 95% confidence intervals and considered significant when P value is < 0.05. Results: Of 671 participants in the study, 52 (7.7%) had DM. At TB treatment completion, there was no statistically significant difference in outcomes between TBDM and TB-only patients (P = 0.40). Patients who received CC were about 32 (OR: 31.60, 95% CI: 3.38-293), and 5 times (OR: 5.08, 95% CI: 1.35-19.17) more likely to achieve success and cure, respectively, compared to those who did not. Conclusion: Provision of CC with DOTS ensured improved TB treatment outcomes in TBDM patients. Recommendations of WHO/The Union are feasible in our setting.

Keywords: Collaborative care, diabetes mellitus, treatment outcomes, tuberculosis


How to cite this article:
Ayeni FA, Oyetunde OO, Aina BA. The effect of collaborative care on treatment outcomes of newly diagnosed tuberculosis patients with Type-2 diabetes mellitus and adverse drug reaction presentations: A prospective study. Int J Mycobacteriol 2021;10:285-92

How to cite this URL:
Ayeni FA, Oyetunde OO, Aina BA. The effect of collaborative care on treatment outcomes of newly diagnosed tuberculosis patients with Type-2 diabetes mellitus and adverse drug reaction presentations: A prospective study. Int J Mycobacteriol [serial online] 2021 [cited 2021 Dec 3];10:285-92. Available from: https://www.ijmyco.org/text.asp?2021/10/3/285/325492




  Introduction Top


Tuberculosis (TB) and Diabetes Mellitus (DM) are recognized major health problems of epidemic proportions.[1] TB is a global leading cause of death infecting about 10 million people annually,[2] and concurrently, about 642 million people are expected to be living with DM by the year 2040, up from 415 million in 2015.[3] There are concerns that TB control is being undermined by the increasing number of people living with TB and DM, which currently stands at an estimated 8.0% in the African region.[4] Poor glycemic control and/or uncontrolled DM in diabetic patients increases the risk of developing active TB infection. It also adversely affects TB disease progression, and co-occurrence of both diseases results in mutual negative interactions leading to worsening prognosis and treatment outcomes.[5],[6]

According to the World Health Organization (WHO), Nigeria has the highest burden of TB, and the third-highest burden of DM, in Africa.[1],[7] Several studies, carried out in different settings within the country revealed that the prevalence of DM in TB patients is substantial, ranging from 9.4% to 12.3%.[8],[9] Despite this, the presence of DM in TB patients undergoing TB treatment often go unrecognized, as it is not part of routine care. Thus, DM is often missed in TB patients, DM care is not given, and TB patients with comorbid DM (TBDM patients) often have poorer TB treatment outcomes compared to their TB-only counterparts.[10]

In response to the TBDM management challenges, the World Health Organization (WHO) and the International Union Against TB and Lung Disease (The Union) launched a Collaborative Framework for Care and Control of TB and DM.[11] This framework seeks to guide the development and implementation of collaborative activities aimed at decreasing the joint burden of DM and TB in populations affected by both diseases. This study adopted the framework to develop essential collaborative activities for the management of TBDM comorbidity in two chest clinics in Lagos state, Nigeria. The study thus aimed at determining the effect of collaborative care (CC) on TB treatment outcomes of TB only and TBDM patients and associated factors of treatment success when managed under a CC model.


  Methods Top


Study design and setting

A prospective, observational study which employed a quasi-experimental study design was conducted among a cohort of TB patients registered in two (a secondary and a specialist) chest clinics in Lagos state, Nigeria. Lagos State, located in the south west part of Nigeria, and home to about 21 million people was created in 1967 and is the commercial nerve center of the country.[12]

Newly diagnosed TB patients with previously undiagnosed DM, aged 18 years and above and known Type 2 DM patients recently diagnosed for TB were included in the study, while TB patients <18 years of age, known or suspected MDR-TB cases, and patients diagnosed with any disease condition other than TB and DM were excluded to avoid the confounding effect on treatment outcome. The sample size for Cross-Sectional, Cohort, and Randomized Clinical Trials at 95% confidence interval (CI) was used to calculate the sample size.[13] Based on required parameters, a sample size of 619 for TB only and 52 for TBDM patients was calculated.

Study instrument/study procedure

A total of 671 patients were recruited using a non-probability consecutive sampling technique.

A structured, pre-tested questionnaire comprising 3 sections was developed to collect data.

Section A obtained information on the patient's sociodemographic data. Section B recorded clinical data such as type and category of TB disease, contact with a past or current TB case, symptoms, habitual risk factors for both TB and DM, family history of TB and DM, and complications of the disease if any. Also recorded for patients with pre-existing DM was the type of DM disease, duration of disease, prescribed antidiabetic medications, and adherence to treatment. Section C recorded reported adverse reactions experienced after treatment initiation, and TB treatment outcomes at the end of Directly Observed Treatment, Short-course (DOTS) therapy.

Diagnosis of TB was based on existing practices in the study center, according to the national TB and Leprosy Control Program and WHO guidelines.[14] Screening and diagnosis of DM were assessed with an initial measurement of random blood glucose (RBG) at treatment initiation, followed with fasting blood glucose (FBG) and glycated hemoglobin (HbA1c) levels measurement one week after, if RBG levels are above 200 mg/dL.[15] Body weights of all recruited patients before starting, and at the end of TB treatment were recorded. Two blood pressure measurements were taken while the patient was in a sitting position and the average of the two readings recorded. Based on their DM status, study participants were divided into two groups: Patients with TB and no DM as TB only patients, and patients with both TB and newly diagnosed or existing DM as TBDM patients [Figure 1].
Figure 1: Flow chart of study methods

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Both groups of patients were managed under DOTS therapy (2RHZE/4RH) for six months[14] while TBDM patients, in addition, were managed under CC which comprised of DOTS, pharmacist's intervention which in turn comprised of adverse drug reaction monitoring, drug-related problem resolution, HbA1c, and monthly FBG monitoring, drug and disease education, and DM management in an endocrinology clinic in accordance with International diagnostic criteria.[15] TB-only patients were passively followed up, while TBDM patients were actively followed with monthly evaluations till the end of TB treatment.

Classifications of treatment outcomes

TB Treatment outcomes were classified and defined in accordance with WHO recommendations.[16] as shown in [Table 1].
Table 1: Definitions of tuberculosis treatment outcomes

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DM treatment outcomes were set as the reduction in symptoms, FBG and HbA1c levels,[17] and successful TB treatment outcomes.

Ethical approval

Ethical approval was obtained from the Health Research and Ethics Committee of Lagos University Teaching Hospital (Assigned No: ADM/DCST/HREC/APP/665). Administrative approval was obtained from Lagos State Health Service Commission (Ref No: SHMB/728/Vol VI/) and informed consent was obtained from all recruited patients.

Data analysis

Data were analyzed using IBM Statistical Package for the Social Sciences (SPSS), version 23.0 (SPSS Inc, Chicago, IL, USA). Summary statistics were presented in tables and charts as frequencies and proportions. Sociodemographic and clinical data were compared between TB only and TBDM patient groups. Differences in proportions between groups were compared by Chi-square analysis. The occurrence of Adverse drug reactions (ADRs) was presented in frequencies and percentages. The association between treatment success and CC, sociodemographic and clinical characteristics of the study participants and presence of ADRs was assessed through univariate, bivariate, and multivariate analyses. Only variables that were significant to a P = 0.05 were included in the multivariate model. All statistical tests were two-tailed, calculated at 95% CIs and considered significant at a P < 0.05.


  Results Top


Patient characteristics

This study revealed a prevalence of DM of 52 (7.7%) among 671 responding TB patients. Compared with TB only patients, TBDM patients were older 48 (92.3%), more female 28 (53.8%) than males, less commonly smear positive 30 (51.7%), and presented with higher blood pressures 24 (46.2%) and body mass index 13 (25%). They also had higher mean random (318.8 ± 90.6) and fasting (207.4 ± 80.3) blood glucose values. Patients in both groups presented with similar pulmonary cases [Table 2]. The presence of DM was significantly associated with gender and family history of DM (P = 0.01), age, weight, functionality status and coughing with sputum (P = 0.00), and contact with active TB case (P = 0.02).
Table 2: Patients sociodemographic and clinical status segregated by diabetes status

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About half, 24 (46.2%) of TBDM patients were newly diagnosed with DM [Table 3]. Compared with known TBDM patients, newly diagnosed TBDM patients were younger (48.5 ± 10.7 years), more female, 15 (62.5%), presented with higher RBG (331.6 ± 98.9) and FBG (216. 8 ± 100.7) values but lesser HbA1c (10.3 ± 2.7) and hypertensive cases, 6 (25%).
Table 3: Characteristics of tuberculosis diabetes mellitus patients segregated by occurrence of diabetes mellitus

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Mean body weights were comparable in both patient groups. Mean HbA1c for all TBDM patients reduced from 10.8% at treatment initiation to 9.7% at treatment completion. Similarly, the mean HbA1c for TBDM patients who were in the CC group reduced from 10.5% at treatment initiation to 8.8% at treatment completion. Average monthly FBG for all TBDM patients reduced from 206.8 mg/dL at TB treatment initiation to 152.1 mg/dL at treatment completion.

Treatment outcomes and associated factors

Equal proportions of patients in both groups (53.8%) achieved cure. TBDM patients recorded more treatment completion, 16 (30.8%) and deaths, 4 (7.7%) compared to TB patients only. More TB-only patients, 68 (11%) and 17 (2.7%) were lost to follow-up and transferred out of their treatment centers, respectively. There was no statistically significant difference in overall treatment success (P = 0.40) and other outcomes between both patient groups when CC was in place [Table 4].
Table 4: Comparison of treatment outcome between tuberculosis only and tuberculosis diabetes mellitus patients who received collaborative care and those who did not

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Univariate analysis evaluating the impact of CC among TBDM patients on treatment outcomes revealed a significant association with treatment success (P = 0.001) and cure rates (P = 0.01). Patients who received CC were about 32 (odds ratio [OR]: 31.60, 95% CI: 3.38–293), and 5 times (OR: 5.08, 95% CI: 1.35–19.17) more likely to achieve success and cure respectively compared to those who did not [Table 4]. No patient in CC was lost to follow-up, transferred out or died.

Bivariate analysis revealed adherence to treatment (P = 0.001), presence of ADRs (P = 0.008), and CC status (P = 0.001) were significantly associated with treatment success [Table 5].
Table 5: Bivariate analysis of factors associated with treatment success

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When subjected to multivariate analysis, patients who adhered to treatment and were in CC were six times (OR: 6.37, 95% CI: 2.46–17.29, P = 0.015), and four times (OR: 3.97, 95% CI: 1.82–9.65, P = 0.028) more likely to experience treatment success, respectively [Table 6].
Table 6: Multiple logistic regression analysis of independent predictors of treatment success

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Adverse drug reaction incidence

Overall, a total of 439 ADRs were reported in this study. Almost half of participants, 280 (41.7%), reported at least one ADR. More TBDM patients, 42 (80.8%), than TB only patients 238 (38.4%) significantly reported an ADR (P = 0.000) [Table 7]. Reports of 2 or more ADRs by a patient were statistically significantly higher (P = 0.0001) among TBDM patients, who, based on Hartwig's severity scale also reported significantly more moderately severe ADRs, 14 (33.3%; P = 0.003), which required more therapy modifications, 12 (28.6%; P = 0.002) compared to TB only patients. They also reported higher percentages of ADRs in all organ systems than TB-only subjects [Figure 2]. Commonly reported ADRs associated with DM were GIT (61.5%), systemic (40.4%), and skin related (17.3%) ADRs.
Figure 2: Prevalence of Adverse drug reactions in tuberculosis patients stratified by diabetes status

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Table 7: Characteristics of reported adverse drug reactions

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  Discussion Top


Despite the reported substantial prevalence of DM among TB patients in Nigeria, there is limited data available regarding the management of comorbidity. This study revealed a 7.7% prevalence of DM among recruited TB patients, consistent with national values and an estimated African prevalence (8.0%)[4],[8],[9]

The study demonstrated that there was no significant difference in TB treatment outcomes between TB only and TBDM patients when they were managed collaboratively. TBDM patients were 32 times, and five times more likely to achieve treatment success and cure respectively under CC than with traditional management in separate clinics, a finding which agrees with suggestions that TB patients who also have DM should be managed in the same setting.[11],[17] These findings are contrary to reports from Maryland, India, and Nigeria, all of which reported differences in treatment outcomes between TB and TBDM patients where TBDM patients had poorer outcomes.[18],[19],[20] However, studies from Thailand and India reported comparable treatment outcomes between both groups of patients where early screening of DM enhanced early diagnosis in TB patients which ultimately led to better glycaemic control during anti-TB treatment, resulting in favorable and comparable treatment outcomes.[21],[22] The difference observed in other studies could have been due to lack of CC as a result of traditional management in separate clinics, DM-associated pill burdens, or uncontrolled glycemic levels.[6],[23] However, the treatment success recorded in this study was just short of the WHO target of 85% treatment success rate.[2] The significant determinants of treatment success in this study were being adherent to treatment, having no ADR, and being in CC management. Having no ADR being a predictor of treatment success agrees with a study in India where having an ADR predisposes TBDM patients to greater risks of treatment failure.[19]

Consistent with reports, about half, 46.2% of TBDM patients in this study were newly diagnosed with DM.[7] Similar studies in India and Indonesia reported newly diagnosed DM of 40% and 73%, respectively, among TB patients.[19],[24] This calls for a high index of DM suspicion in presenting TB patients. High rates of undiagnosed DM predispose to infections such as TB and/or complications of the disease, contributes to adverse TB treatment outcomes, and undermines the ongoing global control efforts for TB.[10],[25] TBDM co-morbidity in this study was significantly associated with being female, of older age, higher body weights, and having a family history of DM. Almost all TBDM patients (92.3%) were older than 40 years when compared to patients with TB only (35.5%). This agrees with suggestions by the WHO and the IULTD[11] and implies that in our setting, to screen and detect over 90% of TB patients who are likely to have DM, only patients older than 40 years need to be screened.

Exposures to TB infection and the presence of TB risk factors are the bedrock of infection. The lesser contacts with active TB cases reported by TBDM patients in this study implies that the development of TB in diabetic patients could have occurred not only as a result of exposure to infectious TB cases but as a result of other factors, such as immune suppressive effects of DM and subsequently reduced immunity in diabetic patients.[17] This is consistent with reports from Ethiopia[26] but contrary in Indonesia where Alisjahbana et al., reported more symptoms in TBDM patients, but with no evidence of more severe disease. Similarly, higher blood pressures recorded among TBDM patients suggests the presence of diabetic risk factors, which if not promptly addressed at the onset could have contributed to the development of DM and the subsequent reduction in their innate adaptive immunity and infection with TB.[6]

FBG and HbA1c being indicators of glycemic control, reflects average plasma glucose over the previous 8 to 12 weeks. In this study, the mean FBG and HbA1c values for TBDM patients were expectedly higher than those of TB-only patients, and also well above recommended values[15] at TB treatment initiation. This is not ideal and indicates that DM was poorly controlled before the patients developing TB and this could have been instrumental to the patient's susceptibility to infections. Reductions in FBG and HbA1c values noted from treatment initiation to completion could have been as a result of collaborative and comprehensive care offered to TBDM patients, thus improving glycemic control, which in turn could have contributed to eliminating the expected worse treatment outcomes attributable to DM. This finding confirms reports that early screening and enhanced DM care may mitigate the impact of adverse effects of DM on TB treatment outcomes.[6],[11],[22] Higher FBG values observed in newly diagnosed TBDM patients call for targeting them with interventions to improve glycemic control and subsequently treatment outcomes. A 1% increment in HbA1c has been associated with a 10%–30% increase risk for total stroke, coronary heart disease, and all-cause deaths.[27]

Multiple drug therapy is the cornerstone of TB treatment and patients may experience a variety of significant ADRs when managed with first-line anti-TB drugs. In this study, almost half (41.7%) of all patients reported at least one ADR. A significantly higher number of TBDM patients reported 2 or more ADRs, which required more therapy modifications compared to their TB counterparts. This could have been caused by the concomitant presence of TB and DM in patients, coupled with the use of multiple drugs in managing both conditions. In addition, TBDM patients also reported higher percentages of ADRs stratified by body organs, the most frequent being systemic signs and symptoms, such as fever, general body weakness, and pain. GIT-related ADRs: Epigastric pain, nausea, vomiting, diarrhea was also rampant, probably due to synergistic side effects of their respective anti-tuberculous and antidiabetic medications. It could also have been as a result of the manifestation of more severe disease in TBDM comorbidity and/or diabetic-related side effects. Other lesser experienced ADRs were skin related: Skin rashes and pruritus, reproductive: Amenorrhea, and classic diabetes-related neuropathy. Similar high proportions of ADRs significantly associated with the presence of DM were reported in India.[19] Contrary to this were those observed in Malaysia.[28] Other studies among TB patients only reported severe side effects of anti-TB drugs as common in patients who have risk factors for ADRs.[29],[30]


  Conclusion Top


The findings of this study demonstrated that the provision of CC with DOTS eliminated the expected worse TB treatment outcomes in TB patients who also have comorbid DM while ensuring improved TB treatment outcomes, which is comparable to those of TB only patients. The study showed that interventions offered by a clinical pharmacist led to reductions in glycaemic and fasting blood levels, and had a positive impact in improving the likelihood of achieving treatment success and cure rates while reducing adverse outcomes.

Acknowledgment

The authors are grateful to Dr. O. Adesola (Infectious clinic, mainland hospital, Yaba), Dr. M. Lawal (DOTS clinic, GH, Odan, Lagos), and Dr. O. Akinlade (Endocrinology clinic, GH, Odan, Lagos) for their encouragement and support of this research in their institutions. We are grateful to the staff of the three clinics for their cooperation. We also thank all patients for participating in this study.

Ethical clearance

The study was approved by the institutional Ethics Committee of Lagos University Teaching Hospital (Approval No: ADM/DCST/HREC/APP/665).

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.



 
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  [Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]



 

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