Evaluation of ultrasound for screening and diagnosis of pulmonary tuberculosis, KwaZulu Natal, South Africa, 2019-20
South Africa, 2019 - 2020
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AHRI.Pocus.AnalyticalDataset.2022.v1
Evaluation of ultrasound for screening and diagnosis of pulmonary tuberculosis, KwaZulu Natal, South Africa, 2019-20
| Name | Country code |
|---|---|
| South Africa | ZA |
Improved tests for screening and diagnosing TB in low-income settings are an essential component of the End TB strategy. Transthoracic ultrasound has generally been considered to perform poorly for the diagnosing pulmonary TB, but newer devices may offer better performance characteristics. The current research was a proof-of-concept study to determine the performance characteristics of thoracic and abdominal ultrasound for the diagnosis of TB in adults compared to a microbiological reference standard under ideal conditions, to inform whether future evaluation and development of the technique is needed.
We recruited participants during the period from October 2019 to March 2020 from two sources:
-
Vukuzazi: A population-based health care screening study (named Vukuzazi), which aimed to describe the frequency and distribution of multimorbidity, including an extensive TB screening component, among adults in the AHRI demographic surveillance area in northern KwaZulu-Natal (Gunda et al., 2021). Participants from this source were eligible if they had undergone a chest radiograph and had results from a sputum sample tested for mycobacteria in the AHRI lab;
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Clinic: Individuals who attended a primary healthcare clinic in KwaZulu-Natal to start TB treatment.
Participants were eligible to take part in the study if they were adults (aged 18 years or above) and healthy enough to travel and participate in the study. We recruited participants from the Vukuzazi study into four groups based on the following criteria:
- group 1: no TB symptoms, negative sputum Xpert MTB/RIF Ultra, normal chest radiograph;
- group 2: negative sputum Xpert MTB/RIF Ultra, abnormal chest radiograph;
- group 3: positive sputum Xpert MTB/RIF Ultra, abnormal chest radiograph;
- group 4, positive sputum Xpert MTB/RIF Ultra, normal chest radiograph.
Participants sampled from the clinic were classified into group 3. This allowed the comparison of those without evidence of TB (group 1) to those with either microbiological or radiological evidence of TB (groups 2-4). Participants from the clinic completed a questionnaire aligned to that used in Vukuzazi concerning health care history, TB symptoms, and HIV and TB treatment. All participants gave venous blood for testing for HIV antibodies. For the primary analysis all participants underwent comprehensive thoracic and focused abdominal ultrasound examination performed according to the study protocol by clinicians masked to all clinical and imaging data. Experienced ultrasonographers interpreted the resulting ultrasound images for the presence of typical chest radiography features of pulmonary or extrapulmonary TB. A comparison of these features between the study groups allowed us to estimate the sensitivity and specificity of individual and combined ultrasound features to detect TB (microbiological/radiological).
Clinical Data
Study participant
Version
V1.0.0
Scope
| Topic | Vocabulary | URI |
|---|---|---|
| Tuberculosis, Ultrasonography, Point-of-Care Testing | Africa Health Research Institute | www.ahri.org |
Coverage
Demographic surveillance area of the Africa Health Research Institute in uMkhanyakude district, KwaZulu-Natal, and a TB clinic near Durban, KwaZulu-Natal.
As above, participants were drawn from two populations. The first population was that covered by the ongoing ARHI demographic surveillance located in rural KwaZulu-Natal which was established in 2000 (Gareta et al., 2021). In 2018, within the ongoing surveillance, the 'Vukuzazi' study offered community-wide health screening and bio-sampling to understand the frequency and distribution of major health care needs in the population (Gunda et al., 2021). For this study we selected adult (18 years and above) participants of Vukuzazi who had completed the full set of TB screening tests and were healthy enough to travel to Durban to undergo the imaging for this the study. This allowed us to sample healthy participants and participants with varying degrees of microbiological and radiological evidence for TB. The second population were adults (18 years and above) who attended a primary healthcare clinic in KwaZulu-Natal to start TB treatment who had microbiologically-confirmed TB.
Producers and sponsors
| Name | Affiliation |
|---|---|
| Prof. Alison Grant | Africa Health Research Institute, Durban, South Africa, London School of Hygiene & Tropical Medicine, UK |
| Dr Emily Wong | Africa Health Research Institute, Durban, South Africa |
| Dr Al Leslie | Africa Health Research Institute, Durban, South Africa |
| Dr Aaron Karat | London School of Hygiene & Tropical Medicine, UK |
| Dr Matthew Fentress | London School of Hygiene & Tropical Medicine, UK |
| Dr Priya Maharaj | Inkosi Albert Luthuli Central Hospital, Durban, South Africa |
| Dr Patricia Henwood | Brigham and Women’s Hospital/Harvard Medical School |
| Name |
|---|
| Africa Health Research Institute |
| Name | Role |
|---|---|
| Bill & Melinda Gates Foundation | Full funding |
| Name | Affiliation | Role |
|---|---|---|
| Dickman Gareta | Africa Health Research Institute | Data management |
| Njabulo Dayi | Africa Health Research Institute | Data management |
| Njabulo Myeza | Africa Health Research Institute | Data management |
| Mthokozisi Mnomiya | Africa Health Research Institute | Data collection |
| Thabani Mtshali | Africa Health Research Institute | Data collection |
| Zoey Mhlane | Africa Health Research Institute | Data collection |
| Nokwanda Ngcobo | Africa Health Research Institute | Data collection |
| Theresa Smit and the AHRI Laboratory Team | Africa Health Research Institute | Lab data collection and analysis |
| Dilshaad Khan | Department of Pulmonology and Critical Care, Inkosi Albert Luthuli Central Hospital, Durban, South Africa | Data collection |
| Mohammed Mitha | Department of Pulmonology and Critical Care, Inkosi Albert Luthuli Central Hospital, Durban, South Africa | Data collection |
| Philip Caligiuri | Department of Pulmonology and Critical Care, Inkosi Albert Luthuli Central Hospital, Durban, South Africa | Data analysis |
| Stephen Olivier | Africa Health Research Institute | Statistical analysis |
| Dirhona Ramjit | Africa Health Research Institute | Study coordination |
| Anita Edwards | Africa Health Research Institute | Study coordination |
| Farina Karim | Africa Health Research Institute | Study coordination |
| Tansy Edwards | LSHTM | Advised on approach to statistical analysis |
| Butterfly Network | Butterfly | Provided an ultrasound device |
Sampling
Sample size was based on precision estimates. With 50 participants with bacteriologically-confirmed TB, we calculated that we would be able to demonstrate ultrasound sensitivity of 80% with a 95% confidence interval (CI) of 67%-89%, and with 100 participants without active TB, we would be able to demonstrate specificity of ultrasound of 80% with a 95% CI of 71%-87%. The study was designed to be exploratory, with a relatively small number of participants, aiming to estimate sensitivity and specificity relatively imprecisely to guide whether larger-scale evaluation was warranted. We did not calculate predictive values because our sample purposively included more people with active TB than would usually be found in routine populations being screened for TB, and thus predictive values from this study could not be generalized.
Data collection
| Start | End |
|---|---|
| 2019-10-01 | 2020-03-30 |
Data Access
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Grant, A. et al. (2022) “Evaluation of ultrasound for screening and diagnosis of pulmonary tuberculosis, KwaZulu Natal, South Africa, 2019-20.” Africa Health Research Institute. doi: 10.23664/AHRI.POCUS.ANALYTICALDATASET.2022.V1
Metadata production
DDI.AHRI.PoCUS.AnalyticalDataset.2022.v1
| Name |
|---|
| Africa Health Research Institute |