International Journal of Infectious Diseases 31 (2015) 4–8

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International Journal of Infectious Diseases

journal homepage: www.elsevier.com/locate/ijid

Health-related quality of life as a predictor of tuberculosis treatment

outcomes in Iraq
Juman Abdulelah Dujaili a,*, Syed Azhar Syed Sulaiman a, Mohamed Azmi Hassali b,
Ahmed Awaisu c, Ali Qais Blebil d, Jason M. Bredle e
a
Discipline of Clinical Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, 11800 Minden, Penang, Malaysia
b
Discipline of Social and Administrative Pharmacy, School of Pharmaceutical Sciences, Universiti Sains Malaysia, Minden, Penang, Malaysia
c
Clinical Pharmacy and Practice Section, College of Pharmacy, Qatar University, Doha, Qatar
d
Department of Clinical Pharmacy, Faculty of Pharmaceutical Sciences, UCSI University, Jalan Menara Gading, UCSI Heights, Kuala Lumpur, Malaysia
e
FACIT.org, Elmhurst, Illinois, USA

A R T I C L E I N F O S U M M A R Y

Article history: Objectives: To determine how tuberculosis (TB) treatment affects the health-related quality of life
Received 23 August 2014 (HRQL) of patients with pulmonary TB and to identify the predictors of favourable TB treatment
Received in revised form 27 November 2014 outcomes in Baghdad, Iraq.
Accepted 1 December 2014
Methods: The Functional Assessment of Chronic Illness Therapy – Tuberculosis (FACIT-TB), a new TB-
specific quality of life instrument derived from the internationally recognized FACIT measurement
Keywords: system for the assessment of HRQL, was administered. The mean total and subscale scores of the FACIT-
Tuberculosis TB at baseline, end of the intensive phase, and end of TB treatment were compared.
Treatment
Results: After the 2-month intensive phase, physical well-being, functional well-being, and the overall
Outcome
total scores were significantly increased (p < 0.01). Furthermore, at completion of TB treatment, there
HRQL
FACIT were significant improvements in the overall HRQL as indicated by the FACIT-TB total score and all
FACT-G subscales, except social and economic well-being and spiritual well-being. In a direct logistic regression
model, only the FACIT-TB total score made a statistically significant contribution towards predicting the
likelihood that a patient would have a favourable TB treatment outcome.
Conclusions: Therapeutic intervention had a positive impact on patient HRQL. We conclude that FACIT-
TB is a reliable tool to monitor HRQL during the course of TB treatment.
ß 2014 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases.
This is an open access article under the CC BY-NC-ND license (http://creativecommons.org/licenses/by-
nc-nd/3.0/).

1. Introduction practical use in clinical practice and clinical trials.2,3 Therefore, we

developed a multi-dimensional HRQL measure specific for pulmonary
The evaluation of therapeutic interventions is no longer limited TB (PTB) patients in Iraq called the Functional Assessment of Chronic
to clinical outcomes such as curing diseases, reducing associated Illness Therapy – Tuberculosis (FACIT-TB). Building on the conceptual
morbidity or symptoms, preventing mortality, and normalizing and methodological framework for the assessment of health status
biomedical markers that have been measured traditionally, but it is proposed by Cella and colleagues in the USA4 and Aaronson and
now also focused on humanistic outcomes such as patient colleagues in Europe,5,6 a modular approach was adopted for the
satisfaction and quality of life (QoL). Hence, health-related quality development of this instrument. The intent was to construct a core
of life (HRQL) assessments are being used in direct patient care questionnaire covering broad domains of QoL, such as physical well-
processes, clinical trials, program evaluations, and for monitoring being, emotional well-being, and social well-being, relevant to a broad
health status in populations.1 range of patients regardless of their specific diagnosis, supplemented
Until recently, no psychometrically robust, concise instrument by disease and treatment-specific (i.e. PTB) modules. The core, general
existed to assess HRQL in patients with tuberculosis (TB) that was of HRQL questionnaire is comprised of the Functional Assessment of
Cancer Therapy – General (FACT-G) items.4 FACT-G was selected
because of its established psychometrics and history in measuring
* Corresponding author. Tel.: +60 14 3427583.
HRQL symptoms in patients with a variety of chronic illnesses as well
E-mail address: [email protected] (J.A. Dujaili). as in the general population.7

http://dx.doi.org/10.1016/j.ijid.2014.12.004
1201-9712/ß 2014 The Authors. Published by Elsevier Ltd on behalf of International Society for Infectious Diseases. This is an open access article under the CC BY-NC-ND
license (http://creativecommons.org/licenses/by-nc-nd/3.0/).
 J.A. Dujaili et al. / International Journal of Infectious Diseases 31 (2015) 4–8 5

Over the past several years, a growing number of studies from 0.81 to 0.93. Item intra-class correlation coefficients for test–
assessing the impact of TB and TB-associated treatment on patient re-test reliability analysis ranged from 0.72 to 0.92.
HRQL have been conducted in many regions.8–13 However, such
studies were lacking in Iraq. Therefore, the current study was 2.3. Data collection
conducted to determine how TB treatment affects HRQL of patients
with PTB attending the Thoracic and Respiratory Disease Specialist When eligible cases were identified, the FACIT-TB was
Centre in Baghdad, Iraq, and to assess the impact of a number of administered and completed by the patient him/herself or through
factors on the likelihood that a patient would have a favourable TB face-to-face interview for those who were illiterate or who had
treatment outcome (i.e., cured or completed treatment). other difficulties. The interviews were conducted by a medical
social worker who was trained prior to the study to standardize the
2. Methods interview procedure. Subsequently, the interviewer conducted a
structured interview using a data collection form to collect
2.1. Study design, setting, and population information on demographics and socio-economic status. The
FACIT-TB HRQL instrument was administered before the respon-
A prospective cohort study was conducted in Baghdad, Iraq dent was asked about socio-demographic characteristics so that
between September 1, 2012 and July 31, 2013, among consecutive any discussion did not affect their answers to the questionnaire.
patients with PTB who received treatment at the Thoracic and Moreover, the interviews were conducted in a quiet, distrac-
Respiratory Disease Specialist Centre, the largest centre for the tion-free area at the study centre after informed consent had been
diagnosis, treatment, and recording of all new and previously obtained from the individual patient. Additionally, patients were
treated TB cases in Iraq. Patients aged 18 years or older at the time informed about the aim of the study, the confidentiality of the data
of PTB diagnosis were included in the study. Patients with any to be collected, and their right to withdraw from the study at any
associated pulmonary diseases such as lung cancer, chronic time. The principal investigator accompanied the interviewer
obstructive pulmonary disease, and asthma, and other chronic during the first 2 months of the data collection for the purpose of
diseases likely to affect HRQL including diabetes mellitus and quality control.
cardiovascular diseases, as well as hospitalized patients and
patients with underlying immune suppression, were excluded 2.4. Statistical analysis
from the study.
Data were analysed using SPSS version 18 software (SPSS Inc.,
2.2. Quality of life and data collection instruments Chicago, IL, USA). Descriptive statistics, such as percentages, mean,
and standard deviation, were calculated. To analyse the signifi-
A standardized data collection tool was designed to collect the cance of the continuous data, the independent samples t-test and
following data: (1) socio-demographic information including age, Mann–Whitney U-test were applied, as appropriate. Furthermore,
gender, marital status, occupation, and educational level; (2) direct logistic regression analysis was performed to assess the
environmental variables including habitat and number of house- impact of a number of factors on the likelihood that a patient
hold contacts; (3) financial status using a measure rating this as would have a favourable TB treatment outcome. Statistical
poor, intermediate, or good; and (4) FACIT-TB questionnaire items. significance was set at p < 0.05 for all analyses.
FACIT-TB is a disease-specific instrument designed to assess
HRQL in patients diagnosed with PTB and is a part of the FACIT 2.5. Ethical considerations
measurement system.14 We followed a modular approach to
develop the FACIT-TB questionnaire. In this approach, a set of items The study protocol, informed consent, and other relevant
assessing QoL issues considered to be relevant and specific to the documents were reviewed and approved by the Research and
target population of TB patients, but not sufficiently covered in the Teaching Aids Division, Training and Development Centre, Minis-
original FACT-G instrument, were added. Furthermore, the new try of Health, Iraq.
subscale structure of the questionnaire was determined through
principal component analysis. It comprises 45 items: 17 items 3. Results
covering physical well-being (possible score range 0–68), seven
items covering social and economic well-being (possible score 3.1. Demographic characteristics of the study participants
range 0–28), 11 items covering emotional well-being/living with
TB (possible score range 0–44), seven items covering functional Three hundred five participants were recruited consecutively
well-being (possible score range 0–28), and three items covering over a period of 11 months. Participants ranged in age from 18 to
spiritual well-being (possible score range 0–12). A 5-point Likert- 91 years, with a mean age of 41.6 years; 64.6% were male and 28.2%
type scale ranging from 0 (not at all) to 4 (very much) is assigned to were illiterate. Furthermore, poor financial status was predomi-
each item. Two different total scores in addition to each individual nant in our cohort and 50.8% of the patients in the sample were the
subscale score can be obtained (FACT-G total score and FACT-G breadwinners for their families (Table 1).
plus disease-specific domain scores). The FACT-G total score
provides a useful summary of overall QoL across a diverse group of 3.2. The effect of TB treatment on patient health-related quality of life
patients. The disease-specific questionnaire total scores (i.e., FACT-
G plus disease-specific subscale score) may further refine the To investigate the effect of TB treatment on HRQL of patients
FACT-G summary score. The FACIT-TB total score ranges from 0 to with PTB, the mean of the FACIT-TB total score and its subscale
180, with a higher score corresponding to a better HRQL. Using a scores at different stages of treatment were compared. Participants
classical psychometric approach, FACIT-TB has demonstrated completed the FACIT-TB questionnaire at baseline, after 2 months
excellent reliability, constructs validity, and is a sensitive of treatment, and at completion of treatment during their regularly
instrument to set clinically significant differences in longitudinal scheduled follow-up visits. After the 2-month intensive phase,
studies of TB treatment. The internal consistency estimate was physical well-being, functional well-being, and FACIT-TB total
0.92 and the Cronbach’s alpha coefficients for the FACIT-TB scores were significantly increased (p < 0.01). Furthermore, there
subscales were uniformly high across all of the subscales, ranging was a significant improvement in overall HRQL as indicated by the
6 J.A. Dujaili et al. / International Journal of Infectious Diseases 31 (2015) 4–8

Table 1 treatment). Preliminary analysis confirmed that poor educational

Demographic characteristics of patients with pulmonary tuberculosis in Iraq
status, poor financial status, and being a smoker, were independent
(N = 305)
determinants of poor HRQL as indicated by the FACIT-TB total
Characteristics n (%), or mean  SD score. Therefore, four independent variables (FACIT-TB total score
Age, years 41.59  15.43 at baseline, smoking status, education level, and financial status)
Sex were included in the model. The full model containing all
Male 197 (64.6) predictors was statistically significant (Chi-square (4,
Female 108 (35.4)
n = 129) = 10.49, p = 0.033), indicating that the model was able
Education status
No formal education 86 (28.2) to distinguish between subjects who had favourable TB treatment
Primary school 132 (43.3) outcomes and those who did not. The model as a whole explained
Secondary school 57 (18.7) between 7.8% (Cox and Snell R-square) and 11% (Nagelkerke R-
University 30 (9.8)
square) of the variance in treatment outcome, and correctly
Marital status
Single 71 (23.3)
classified 69% of the cases. As shown in Table 3, of the independent
Married 208 (68.2) variables, only the FACIT-TB total score at baseline made a unique
Divorced 4 (1.3) statistically significant contribution to the model. The FACIT-TB
Widow/widower 22 (7.2) total score at baseline recorded an odds ratio of 1.02. This indicates
Number of household members 7.72  4.08
that the higher the FACIT-TB total score at baseline, the more likely
Type of the job
Salaried 60 (19.7) that a PTB patient will have a more favourable outcome at the
Waged 18 (5.9) completion of treatment, while controlling for the other factors in
Self-employed 93 (30.5) the model.
Other 134 (43.9)
Breadwinner
No 150 (49.2) 4. Discussion
Yes 155 (50.8)
Financial status A study of the impact of PTB on various aspects of QoL is
Poor 115 (37.8) possible by using a disease-specific HRQL measure. QoL has
Intermediate 88 (28.9)
Good 102 (33.3)
become an instrumental outcome measure in clinical research, and
Smoking status advances have been made in assessing the impact of many diseases
Never smoker 135 (44.3) on QoL.10 Different generic HRQL instruments and health utility
Ever smoker 170 (55.7) measures such as SF-36, SF-12, EQ-5D, WHOQOL-100, and
WHOQOL-BREF, have been used among the studies that have
quantitatively assessed health for patients with TB.2 Although
FACIT-TB total score and all subscales, except social and economic these instruments have been applied successfully to measure QoL
well-being and spiritual well-being at completion of TB treatment in patients with TB, perhaps the most significant drawback has
(Table 2). been the absence of a widely accepted psychometrically robust TB-
specific instrument for carrying out such assessments in the
3.3. Factors predicting the likelihood of a favourable TB treatment context of TB.2,3,15
outcome In the current study, the gradual increase in physical well-
being, functional well-being, and emotional well-being/TB sub-
Direct logistic regression was performed to assess the impact of scale scores over the course of TB treatment indicates the positive
a number of factors on the likelihood that a patient would have a impact of therapeutic interventions on patient QoL. However, the
favourable TB treatment outcome (i.e., cured or completed emotional well-being/TB subscale score at 2 months of TB

Table 2
Health-related quality of life determination over the course of tuberculosis treatment using the FACIT-TB instrument; FACIT-TB total and subscale scores (mean  SD)

PWB SEWB EWB/TB FWB SpWB Total score

At baseline 31.93  17.62 22.45  5.11 20.54  9.65 12.97  7.17 9.67  2.75 97.56  30.14
(n = 136)
After 2 months of treatment 38.30  18.04a 22.50  5.27 20.78  11.04 13.89  7.67a 9.61  2.80 105.10  30.20a
(n = 136)
At completion of treatment 49.75  14.58a,b 22.57  4.70 28.43  10.50a,b 17.41  6.74a,b 10.56  7.88 128.72  25.28a,b
(n = 109)

EWB/TB, emotional well-being/stigma of having TB; FACIT-TB, Functional Assessment of Chronic Illness Therapy – Tuberculosis; FWB, functional well-being; PWB, physical
well-being; SD, standard deviation; SEWB, social and economic well-being; SpWB, spiritual well-being.
a
p < 0.01 compared to score at baseline.
b
p < 0.001 compared to score after 2 months of treatment.

Table 3
Logistic regression analysis for predicting the likelihood of a favourable TB treatment outcome

B SE Wald df p-Value OR 95% CI for OR

FACIT-TB total score at baseline 0.019 0.008 6.280 1 0.012 1.020 1.004–1.035
Smoking status 0.222 0.411 0.292 1 0.589 0.801 0.358–1.792
Education status 0.153 0.237 0.416 1 0.519 1.165 0.732–1.856
Financial status 0.044 0.257 0.029 1 0.865 0.957 0.579–1.584
Constant 1.024 0.728 1.975 1 0.160 0.359

SE, standard error; OR, odds ratio; 95% CI, 95% confidence interval; FACIT-TB, Functional Assessment of Chronic Illness Therapy – Tuberculosis.
 J.A. Dujaili et al. / International Journal of Infectious Diseases 31 (2015) 4–8 7

treatment did not significantly differ from baseline. Studies have QoL instrument as a prognostic variable beyond established
demonstrated that emotional stress is associated with immuno- predictors in patients with PTB in Iraq and suggests that such
logical responsiveness and reactivation of bacillus.16 Moreover, the an instrument could reliably be used to monitor patient QoL
psychiatric complications as adverse effects of anti-TB medications progression. Understanding QoL trends according to specific
are also a matter of concern.17 These factors are viewed as a major domains will provide a basis for relating patient reported
barrier to treatment adherence.17 The risk of treatment default is outcomes with drug therapy and identifying domains that require
high during the first 2 months of TB treatment,18 suggesting that other interventions such as social support. Further research is
better management of emotional stress could improve treatment needed to provide more insight into the predictive validity and
outcomes and will serve as a framework for effective TB control. sensitivity of the instrument. Research is also needed to replicate
International health agencies are considering strategies to inte- these findings and to confirm them in other patient populations.
grate mental health services into the existing health systems for
the purpose of increasing responsiveness to patient needs.19 Acknowledgements
A study carried out to identify how TB affects the QoL of patients
attending two directly observed therapy (DOTS) centres in an The authors would like to thank the investigators of the
urban area of Delhi using the Hindi version of the WHOQOL-BREF Thoracic and Respiratory Diseases Specialist Centre in Iraq for their
questionnaire also reported similar results.10 The final findings help and support in the collection of the required data. We also
demonstrated that there was a significant increase in the overall greatly acknowledge the support provided by the FACIT measure-
QoL and in all domains except social after 3 months and at ment system and FACT-G developers for granting permission to
completion of treatment under DOTS, and that the maximum use the FACT-G and for their input during the FACIT-TB
improvement was seen in the physical domain followed by the development process. This research project was sponsored in part
psychological domain. Moreover, our results are consistent with by a grant from Universiti Sains Malaysia, Research University
the pattern observed in a study conducted in China using the SF-36 Postgraduate Research Grant Scheme (USM-RU-PRGS; grant
questionnaire,8 in which all physical scales including physical number 1001/PFARMASI/845040).
functioning, bodily pain, role-physical, and general health scores Conflict of interest: The authors declare that no conflicts of
showed a significant increase over the course of TB treatment interest exist.
(p < 0.05), while the improvement in vitality and mental health
was statistically not significant.
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