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Tuberculosis in the Time of COVID-19: Quality of Life and Digital Innovation
PDPI Lampung & Bengkulu, 09 Jun 2020 15:18:13

Introduction: the COVID-19 “storm” on individuals, patients and health care professionals

The year 2020 will be remembered as the year COVID-19 swept the world and overwhelmed healthcare systems, demonstrating several vulnerabilities and lack of capacity.

The “COVID-19” storm has created much damage, and will hopefully end (with or without secondary waves, we do not know yet) leaving us in the aftermath with numerous challenges for the different actors involved (table 1) [1, 2].

TABLE 1

Selected challenges or changes for healthcare staff and patients during the COVID-19 epidemic

Challenge Changes/unwanted consequences Affected
Lockdown • Loss of work, loss of income
• Increase in mental health issues, domestic violence and suicide
• Limited possibilities of transportation to health care facilities
• Aggression and racism against minorities
• Cancellation of appointments and elective surgery
• Reduced or negated access to hospital to visit love ones
• Reduced or no access to funerals and religious cerimonies
• Less attention/priority for co-morbidities or other diseases (i.e. avoiding to access health care facilities for fear even in the presence of severe symptoms)
• Personal drug procurement: less access to pharmacies, especially to hospital pharmacies and public dispensaries
• Drugs distribution irregularities
• Nursery and school closures
• Loss of exams, school years
• Loss of holidays
• Patients
• HCWs
• Everyone
Social distancing • Reduction in support from peers, social workers, relatives, friends
• Increased isolation and deprivation
• Challenges in travelling: disruption of public transport, fewer seats available, booking necessity (even for short-medium distances)
• Long queues for shopping of essentials
• Increase in mental health issues, domestic violence and suicide
• Patients
• Everyone
Differential diagnosis • Increase in number and type of diagnostic procedures and tests (to exclude or confirm concomitant COVID-19)
• Reduction in spirometry, imaging and ultrasonography due to infection control concerns
• Lack of reagents due to unprecendented global demand
• Lack of laboratory capacity
• Reduced medical workforce due to illness
• Misdiagnosis, especially of respiratory co-morbidities (at least during COVID peaks)
• Delayed diagnosis
• Underestimation of clinical impact of concomitant co-morbidities (respiratory or not)
• Challenges in diagnosis of COVID versus TB sequelae
• Patients
• HCWs
Avoiding transmission of SARSCoV2 in healthcare settings • Reduction in number of patients evaluated per day (more time needed to assess patients)
• Changes in flow for diagnosis and visits within health facilities
• Slower procedures: triage pre-entry; disinfection after each visit/diagnostic procedure; personal distancing (from a patient to another or from patient to health staff), etc.
• Postponement of appointments (at least during COVID peaks)
• Temporary discontinuation of rehabilitation activities (at least during COVID peaks)
• Limiting outpatients’ activities to urgent issues (at least during COVID peaks)
• Replacement of face-to-face activities towards phone, remote web-based interactions (including psychological support; adherence support initiatives, etc)
• Stockouts of protective equipment (at least during COVID peaks)
• Increased cost of healthcare services
• Patients
• HCWs
Peaks of epidemics • Shift of resources (financial, staff, protective equipment, laboratory, other diagnostics, etc.) from existing programmes to COVID
• Paralysis of emergency departments (at least during COVID peaks)
• Shift of HCWs to COVID wards
• High transmission of SARSCoV2 to HCWs: sick leave, HCWs hospitalisations, HCWs deaths
• Health staff for contact tracing activities shifted to COVID activities
• Rapid exhaustion of protective equipment (at least during COVID peaks)
• Lack of drugs, oxygen, consumables
• Lack of invasive and non-invasive ventilators
• Patients
• HCWs

Legend: HCWs: health care workers; TB: tuberculosis.

Healthy individuals. Widespread worldwide implementation of social distancing measures, lockdown, unprecedented economic crisis with resultant unemployment and not knowing when it will end, have generated anxiety and an increase in mental health issues and suicide.

Patients. Varying numbers globally, with important mortality particularly amongst the elderly and patients with pre-existing co-morbidities. The socio-economic consequences of the storm are contributing to increase poverty, deprivation, isolation, malnutrition and related morbidity and mortality [3].

Healthcare professionals. A nightmare, with request to focus on COVID-19 as the priority; redistribution of healthcare workers into clinical duties, devoting all their energy to prevent, diagnose and treat this new disease with limited possibilities to rest and enjoy their family, whilst observing an unprecedented pressure on the health system and many colleagues admitted (3.8% in China to 6% in UK and 10% in Spain) and –unfortunately- dying.

A common observation which has been the subject of debate in several medical journals was the rapid reorganisation of health systems to tackle the COVID-19 pandemic by increasing the number of intensive care unit (ICU) beds [4], reducing/cancelling out-patient activities and non-urgent clinical activities (e.g. screening and follow-up activities, elective surgery, etc.). Another important shift was to substitute, in whichever way possible, clinical examinations and “in person” meetings with phone consultations and web-based activities [5].

In many countries pulmonologists, infectious disease and public health experts (those also involved in TB prevention and care) together with ICU specialists are or have been re-deployed to the frontline to fight COVID-19 [5].

COVID-19 and TB services

A modelling analysis [6] commissioned by the STOP TB Partnership, Geneva, Switzerland, indicates that the COVID-19 pandemic is deeply affecting TB services effort in prevention, case-detection and management. This is particularly evident in resource-limited settings but also in resource rich settings to varying degrees [6]. As a result, an increase of TB incidence and mortality is expected in the coming future potentially compromising the results achieved so far and delaying the End TB strategy timelines [6].

To support the ongoing discussion on the association between COVID-19 and TB the analysis of 2 cohorts of co-infected patients show that COVID-19 can appear before, simultaneously or after TB (including patients with post-TB treatment sequelae) [79] and that mortality is higher amongst elderly TB patients with pre-existing comorbidities [9].

There are 2 interesting topics which are generating scientific debate: the effects of TB on Quality of Life (QoL) of TB patients with or without COVID-19 before, during and after the end of anti-TB treatment (with need for pulmonary rehabilitation) and the potential offered by web-based approaches for TB management [10].

We aim to discuss these two areas by presenting 2 articles appearing in this issue of the ERJ [11, 12] and making a rapid scoping review on the evidence available on TB, QoL and TB rehabilitation in the literature searching on Medline and in the grey literature. The key-words “quality of life”, “pulmonary rehabilitation” and “tuberculosis” were used without any time limits.

Tuberculosis, QoL and pulmonary rehabilitation

Fifty-one records were identified including a review focused on the effectiveness of pulmonary rehabilitation in patients with post-treatment sequelae, 5 original articles [1317] and 1 case-report [18] reporting both pre- and post-TB rehabilitation information on at least one core examination (i.e., spirometry, walking test, QoL tests) [1319]. The studies all reported in English, were conducted in 4 continents (Africa, Asia, Europe and Latin America) with a small sample size (1–64 patients), 50% of them on in-patients basis. The 6-min walking test (6MWT) or equivalent was conducted in all studies as well as QoL tests. The mean distance covered with the 6MWT was significantly higher after pulmonary rehabilitation, ranging from 11 to 110 meters.

In five studies spirometry was conducted showing improvement of the core spirometry parameters (FEV1: forced expiratory volume in the 1st second; FVC: Forced Vital Capacity) after pulmonary rehabilitation, although age and smoking habits were different in the different studies.

Among the main messages of the existing review [19] we underline: a) the high proportion of patients with post-TB treatment sequelae suffering from limited capacity to perform exercise and poor QoL; b) the effectiveness of pulmonary rehabilitation in improving walking distance (6MWT), the QoL assessment and core spirometry parameters and the need for further research [20].

The importance of QoL in TB is increasing over time. According to WHO, health is “a state of complete physical, mental, and social wellbeing and not merely the absence of disease or infirmity”.

Therefore, QoL is getting a precise role under the WHO-recommended vision of “people-centred care”, which is in-built in the End TB Strategy [21].

The traditional vision of National TB Programmes, largely due to historical funding constraints, focused on improving treatment success rates more than on individual post-treatment wellbeing [13, 22].

In recent years, and before the COVID-19 pandemic, more and more countries (starting from Brazil, Russia, South Africa and other intermediate-income ones) are showing interest on the rehabilitation of post-treatment sequelae due to increased access to funding and technology [22].

Among the different QoL tools reported in the literature [23] we have generic questionnaires (e.g. 36-item Short Form-SF health survey or SF-36 and its shortened version with 12 questions, the SF-12) or specific tools as the SGRQ (St. Georges's Respiratory Questionnaire) specifically investigating QoL in chronic respiratory diseases (table 2).

TABLE 2

Tools available to evaluate Health Related Quality of Life, generic and specific for Chronic Respiratory Diseases (tuberculosis, asthma, COPD, non-cystic fibrosis bronchiectasis)

Generic HRQL questionnaires
Questionnaire Items Domains Administration time Mode of administration Score
World Health Organization Quality of Life questionnaire
WHOQOL-100
100 1. Physical Health
2. Psychological
3. Level of Independence
4. Social Relations
5. Environment
6. Spirituality/Religion/Personal beliefs
30 min. Self-administered Scores available for domains, facets, and overall.
Higher scores indicate better HRQoL#
World Health Organization Quality of Life questionnaire
WHOQOL-BREF
26 1. Physical health
2. Psychological
3. Social relationships
4. Environment
10–15 min. Self-administered Items answered by using individualized five-point scales. Each subscale is scored positively.
Higher scores indicate better HRQoL
EUROHIS-QOL 8 1. Physical health
2. Psychological
3. Social relationships
4. Environment
10 min Self-administered Items answered by using individualised five-point scales. Each subscale is scored positively.
0–32
Higher scores indicate better HRQoL
The Short Form (36) Health Survey
SF-36v2
36 1. Vitality Vitality
2. Physical functioning
3. Bodily pain
4. General health perceptions
5. Physical role functioning
6. Emotional role functioning
7. Social role functioning
8. Mental health
10±8 min. Self-administered Higher scores indicate better HRQoL
The correct calculation of SF-36 requires the use of special algorithms, which are strictly controlled by a private company#
Euroqol 5 dimensions
EQ-5D
5 1. Mobility
2. Self-care
3. Usual activities
4. Pain/discomfort
5. Anxiety/depression
Additional perceived health status measured through a visual-analogue scale (VAS)
5–10 min. Self-administered Two scores, one for the 5 domains and another for the VAS.
5 domains score: 1–3
Higher scores indicate worse HRQoL
VAS score: 0–100
Higher scores indicate better HRQoL
Nottingham Health Profile (NHP) 38 1. Physical mobility
2. Pain
3. Social isolation
4. Emotional reactions
5. Energy
6. Sleep
5–10 min. Self-administered 0–100
Higher scores indicate worse HRQoL
HRQOL Questionnaires for Chronic Respiratory Diseases
Functional Assessment of Chronic Illness Therapy
FACIT-TB
(Tuberculosis)
47 1. Physical Well-Being
2. Psychological Well-Being
3. Function Well-Being
4. Social Well-Being
5. Spiritual Well-Being
6. Environment
7. Perception
16.3±3.1 min. Self-administered
0–180
Higher scores indicate better HRQoL
Pulmonary Tuberculosis Scale of the System of Quality of Life Instruments for Chronic Diseases
QLICD-PT
(Tuberculosis)
40 1. Physical domain
2. Psychological domain
3. Social domain
4. TB Specific domain
 Approximately 10 min.  Self-administered 0–100
Saint George Respiratory Questionnaire
SGRQ
(Asthma and COPD)
76 1. Symptoms
2. Activity
3. Impacts
15/20 min. Self-administered 0–100
Higher scores indicate worse HRQoL
Maugeri Respiratory Failure Questionnaire
MRF-28
(Chronic respiratory failure)
28 1. Daily activities
2. Cognition
3. Invalidity, and additional items related to fatigue, depression and problems with treatment
15±6 min Self-administered 0–100
Higher scores indicate worse HRQoL
Chronic Respiratory Disease Questionnaire (CRQ)
(Chronic Respiratory Disease)
20 1. Dyspnoea
2. Fatigue
3. Emotional function
4. Mastery of disease
15–25 min Interviewer administered Numerical, 7-point modified Likert Scale
Higher scores indicate better HRQoL
Quality of Life-Bronchiectasis
QOL-B
(Non-cystic fibrosis Bronchiectasis)
37 1. Respiratory Symptoms
2. Physical
3. Role
4. Emotional
5. Social Functioning
6. Vitality,
7. Health Perceptions
8. Treatment Burden
4–5 min. Self-administered 0–100
Higher scores indicate better HRQoL
Asthma Quality of Life Questionnaire
AQLQ
(Asthma)
32 1. Symptoms
2. Activity Limitation
3. Emotional Function
4. Environmental Exposure
4–5 min. Self-administered 1–7
Higher scores indicate better HRQoL

HRQoL: Health-Related Quality of Life; QoL: Quality of Life, COPD: Chronic Obstructive Pulmonary Disease; TB: tuberculosis.

# www.optum.com/solutions/life-sciences/answer-research/patient-insights/sf-health-surveys.html;.

Details on scoring are included in manuals available from The WHOQOL Group: www.who.int/healthinfo/survey/whoqol-qualityoflife/en/index2.html.

QoL, treatment outcomes and the EURO-HIS questionnaire

Among the available questionnaires, the EQ-5D and SF-36, used to calculate quality adjusted life years (QALY) have been also used in TB [24, 25]. Unfortunately, they cannot capture the economic and social “areas” which are important for TB, given its relationship with poverty and isolation.

The WHO QoL group developed a 100-item questionnaire able to capture different QoL aspects in different cultural environments and with different languages.

Shorter versions were also developed for operational research and clinical use like the 24-question WHO-QOL-BREF, and the 8-question EUROHIS-QOL questionnaire [26].

Both tools assess the 4 QoL core dimensions which are relevant for TB patients: physical health, psychological health, social interactions and satisfaction with living conditions, including economic QoL [2630] The EUROHIS-QOL is a brief questionnaire with the potentialities of retaining the psychometric properties of WHO-QOL-BREF, but has only been used to evaluate QoL in few conditions [31].

In this issue of the ERJ, Datta S. et al. [11] report on QoL and treatment outcomes in a case-control and nested cohort of patients. The study in different settings (rural and urban) in Peru involving 1545 patients (individuals aged more than 15 years initiating anti-TB treatment in community health centres), 3180 “contacts” (individuals reporting to share the patient's household for more than 6 h per week in the 2 weeks preceding the patient's start of anti-TB treatment) and 277 “controls” (randomly selected within the same communities). The sample size, evaluated post-hoc, ensured >90% power at the 95% significance level to detect a 4-point QoL score difference in patients versus controls, and a 1-point difference in contacts versus controls.

The study results indicate that the EUROHIS-QOL 8-item questionnaire is a valid instrument to measure general QoL in TB patients. The vast majority of patients completed it showing that the questionnaire is reliable and therefore a valid tool to evaluate QoL in these patients. Importantly, patients with TB (and especially multidrug-resistant (MDR)-TB) had lower QoL than community controls as far as TB symptoms and psychosocial QoL dimensions are concerned. Finally, TB patients with lower QoL at diagnosis were less likely to complete their TB treatment cycle and survive. Furthermore, the study allowed to evaluate the QoL among patients’ household contacts.

This study shows that programmatic QoL evaluation is feasible, and can be conducted with simplified tools to improve the outcomes of TB and MDR-TB treatment.

Adherence and e-health

Adherence is a core component of TB treatment, as the traditional dogma of TB control is that rapid and effective treatment is the best preventive measure to reduce infectiousness and break the chain of transmission within the community [32].

Under this perspective, high adherence is core to ensure high success rates at the end of treatment, and DOT (Directly Observed Therapy) or its electronic version (VOT, Video Observed Therapy), important tools supporting it.

Ravenscroft et al., in this issue of the ERJ, evaluate the effectiveness of VOT for the first time in low and middle-income countries [12]. The Authors evaluated effectiveness and patient cost-difference of VOT by comparing VOT VS. clinic-based DOT in Moldova. The study was designed as a 2-arm randomised trial including 98 cases (VOT group) and 99 controls (DOT group) with observed medication adherence (measured by the number of days per two-week period that a patient failed to be observed taking medication).

The Authors found that VOT significantly decreased non-adherence by 4 days per a 2-week period (5.24 days missed per two-week period for DOT and 1.29 per VOT). Under the economic perspective, VOT patients spent approximately 30$ and 58 h less on their treatment than DOT ones. As in the majority of DOT studies, no significant improvements were found among VOT patients on treatment success as well as for patient wellbeing or patient employment status.

The main messages of this study is that, first of all, VOT is feasible in a Eastern European setting, and that VOT saved patients’ time and money, and increased satisfaction. These results “per se” useful and justifying larger studies (the sample size was relatively small) evaluating programmatic feasibility, are even more relevant in a context of COVID-19 pandemic, when prevention of transmission and need to focus on essential services has reduced the volume of out-patient activities. This, unfortunately, is affecting TB activities in several countries. An additional important result is the increase of adverse events reporting. This need to be seen as a positive “effect” of VOT, which allows otherwise not emerging adverse events to be reported, as recommended by WHO [33].

Conclusions

Lack of staff, protective equipment, tests, drug stock-outs are all well known in the management of TB in diverse settings; this has now unfortunately spread to other programmes and systems. COVID-19 will invariably affect the lung health of many and potentially lead to greater incidence of TB over the coming years. It is already evident that the pandemic has delayed our ambitious End-TB strategy timelines, so that greater attention and investments will now be needed to control TB.

The rehabilitation and QoL of TB patients is gaining traction as we understand that patients continue to have sequelae beyond TB treatment completion and more is required to improve QoL and raise life expectancy in this group of patients.

COVID-19 is radically changing the way we manage TB in the immediate future and is forcing us to accelerate the adoption of digital innovations that simplify and facilitate healthcare workers’ workload.

COVID-19 has unmasked and laid bare several vulnerabilities already well known in the TB world; innovation and digital technologies will need to be adopted to help us get back on track.

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