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Table 1 Data Extraction of longitudinal studies evaluating HRQOL and adherence in TB

From: Health-related quality of life and its association with medication adherence in active pulmonary tuberculosis– a systematic review of global literature with focus on South Africa

Reference

Study Objective

Study Setting/Sample Size

Population

Comparator Group

HRQOL Measure

Application time pointof HRQOL Measure

Overall Outcome in HRQOL

Outcomes in HRQOL Domains

Aggarwal et al.2013 [10]

To quantify impairment in HRQOL and to evaluate the utility

India

N = 1034

Newly diagnosed PTB patients

None

WHOQOL-BREF

Hindi version

1st time point: within 2 weeks of initiating intensive phase 2nd time point: within 2 weeks of switching to continuation phase 3rd time point: within 2 weeks of stopping treatment

Impaired HRQOLimproves significantlywith anti-tuberculosistreatment. Residualimpairment is noticedin some patients at theend of treatment

Patients in urban areas and those with higher socioeconomic status (SES) have higher domain scores and better HRQOL. The WHOQOL-BREF physical and psychological domain scores are significantly lower and more affected than other domains.

Atif et al. 2014 [64]

To evaluate the impact of TB treatment on HRQOL

Malaysia

n = 216

New smear positive PTB patients; no HIV co-infection

None

SF-36 v2 Tamil, Malay and Mandarin version

1st time point: start of treatment 2nd time point: end of intensive phase 3rd time point: end of treatment

Impaired HRQOL improves significantly with anti-tuberculosis treatment. Scores inthe physical and mental health components were still impaired after end of treatment

Health domains improve between baseline and end of the intensive phase, and end of treatment, except for bodily pain and vitality. At the start of treatment, 67.1 % of patients are at risk of depression, compared to 35 % at end of intensive phase and 23.5 % at end of treatment. Patients aged <45 years and/or non-smokers have a better mean physical component summary (PCS)score. Lower and affected mental health is related to smoking, low income and presence of more than three TB symptoms.

Balgude et al. 2012 [19]

To assess the impact of TB and treatment on HRQOL

India

n = 60, (30 patients and 30 controls)

Newly diagnosed smear positive TB patients

Healthy control from the general population

WHOQOL-BREF plus 2 items examined separately

1st time point: baseline 2nd time point: after 2 months 3rd time point: after 4 months

At baseline, HRQOL is significantly affected with physical and psychological domains most affected. All domains improve after 2 and 4 month treatment.

Mean scores of patients’ physical and psychological domains are lower than controls at all 3 time points of assessment. There is significant improvement in the scores at 2 & 4 months of treatment. The mean scores of patients’ environmental and social domains are lower than control at baseline, but improve at 4 months of treatment and are comparable to control

Chamla 2004 [29]

To assess impact of TB and treatment on HRQOL

China

n = 205, (102 patients and 103 controls

TB patients

General population without TB

SF-36

Chinese version

1st time point: before treatment 2nd time point: after 2 months 3rd time point: end of treatment.

HRQOL is impaired at baseline with physical scales most affected and improves due to treatment.

Treatment improves all domains; at end of treatment physical functioning, role-emotional, bodily pain, social functioning and general health are not different from control. Physical scales are more commonly affected than mental health scales.

Dhuria et al. 2009 [26]

To assess impact of TB and treatment on HRQOL

India

n = 180,(n = 90 patients and 90 controls)

TB patients

General population matching for age, gender and socioeconomic status

WHOQOL-BREF

Hindi version

1st time point: baseline 2nd time point: 3 months 3rd time point: end of treatment.

TB patients have an impaired HRQOL with significant improvement in all domains except social domain after treatment.

The highest improvement is in physical domain, followed by psychological domain. The mean score of overall HRQOL and physical domain at completion of treatment is better in females than males. Males score better in psychological, social and environmental domains. After end of treatment HRQOL is still affected in physical domains compared to healthy controls.

Kruijshaar et al. 2010 [39]

To assess the impact of TB and its treatment on patients’ health status

UK

n = 61

TB patients

None

SF-36 v2

UK version

EQ-5D

STAI-6 CES-D

1st time point: diagnosis 2nd time point: 2 months

Impaired HRQOL improves already after 2 month treatment, but is still below the UK norm score

SF-36 v2 scores improve significantly except for physical functioning, general health perceptions and physical summary score. Vitality, mental health and mental health summary scores are comparable to the UK norm. EQ-5D: pain/discomfort andproblems with self-care improvewhile a borderline decrease is seen for mobility, except for self-care. Depression and anxiety improveddue to treatment (CES-D andSTAI-6 scores). 51 % report economic burden due to TB.

Maguire et al. 2009 [66]

To quantify the impact of TB HRQOL

Indonesia

n = 115

smear positive PTB patients

None

SGRQ

1st time point: baseline 2nd time point: 2 months 3rd time point: 6 months

Impaired HRQOL improves with treatment at 2 and 6 months

Although HRQOL improves due to treatment 24.6 % of patients still have significant lung function impairment after at end of treatment

Mamani et al. 2014 [65]

To assess the QOL among TB patients

Iran

n = 184 (64 patients and 120 controls)

Pulmonary and extrapulmonary TB patients

Healthy control from general population

SF-36

Persian version

1st time point: baseline 2nd time point: 2 months 3rd time point: 6 months

Impaired HRQOL improves due to treatment compared to controls

All domains of SF-36 aresignificantly impaired andimprove after 2 month treatment; improvement betweentwo and six months is not significant. Physical functioningand energy are most affected.

Marra et al. 2008 [28]

To identify areas of HRQOL affected by latent and active TB; treatment impact on HRQOL

Canada

n = 206 (104 active TB and 102 latent TB)

Active and latent TB patients (LTBI)

LTBI defined as a positive TST result without radiographic or clinical evidence of active TB

SF-36 v2

BDI

1st time point: baseline 2nd time point: 3 months 3rd time point: 6 months

At baseline HRQOL is more affected in active than latent TB patients. Treatment improves HRQOL in active but not in latent TB. Patients with active TB have still impaired HRQOL after treatment completion compared to US norms.

All domains of SF-36 improve overtreatment in active and latent TBexcept bodily pain inactive andexcept social functioning andvitality in latent TB.BDI showsnoimprovement in LTBIparticipants, but significant improvement for those with active TB.

Ralph et al. 2013 [17]

To investigate morbidity over TB treatment period

Indonesia

n = 240, (200 patients and 40 controls)

smear positive TB

Healthy control from the general population

SGRQ

Indonesian version

1st time point: baseline 2nd time point: 4 weeks 3rd time point: 8 weeks 4th point time: 24 weeks

Impaired HRQOL improved over treatment time.

After treatment 27 % of TB patients have moderate to severe pulmonary function impairment. HIV -positive status was significantly associated with worse HRQOL

Reference

Study Objective

Study Setting

Population

Comparator Group

Adherence Measure

Application time point of Adherence Measure

Overall Outcome in Adherence

Specific Outcome in Adherence

Chirwa et al. 2013 [51]

To estimate cure rates, and their association with adherence to TB treatment

Malawi

n = 524

TB patients

None

Retrospective counting of missing days during treatment

Retrospective review of records

Adherence to TB treatment had a significant effect on cure of TB

Overall, 35.1 % of patients did not fully adhere to TB treatment. Of these, 86.4 % missed < 15 days and 23.4 % missed at least 1 day of treatment Overall, 92.7 % of patients were cured from TB and 33.7 % of these missed at least 1 day of treatment. Patients who missed <15 days and 15 to 29 days of treatment were less likely to be cured compared with those who fully adhered.

  1. Table 1: data extraction from 11 longitudinal studies evaluating HRQOL (10 studies) and adherence (1 study)
  2. SF-36 short form 36, EQ-5D EuroQol 5 dimensions, SGRQ St. George’s respiratory questionnaire, WHOQOL-BREF World Health Organization Quality of Life Short Form, BDI Beck’s depression index, STAI-6 state-trait anxiety short-form, CES-D Center for Epidemiologic Studies Depression Scale