10.5061/DRYAD.FFBG79CTB
MacPherson, Peter
0000-0002-0329-9613
Liverpool School of Tropical Medicine
Data from: Computer-aided X-ray screening for tuberculosis and HIV testing
among adults with cough in Malawi (the PROSPECT study): a randomized trial
and cost-effectiveness analysis
Dryad
dataset
2021
Tuberculosis
Screening
Clinical trials Randomized controlled
Global health
Wellcome Trust
https://ror.org/029chgv08
206575/Z/17/Z
2021-08-25T00:00:00Z
2021-08-25T00:00:00Z
en
135450 bytes
6
CC0 1.0 Universal (CC0 1.0) Public Domain Dedication
Suboptimal tuberculosis (TB) diagnostics and HIV contribute to the high
global burden of TB. We investigated costs and yield from systematic
HIV-TB screening, including computer-aided digital chest X-ray (DCXR-CAD).
Suboptimal tuberculosis (TB) diagnostics and HIV contribute to the high
global burden of TB. We investigated costs and yield from systematic
HIV-TB screening, including computer-aided digital chest X-ray (DCXR-CAD).
In this open, three-arm randomised trial, adults (≥18 years) with cough
attending acute primary services in Malawi were randomised (1:1:1) to
standard-of-care (SOC); oral HIV testing (HIV screening) and linkage to
care; or HIV testing and linkage to care plus DCXR-CAD with sputum Xpert
for high CAD4TBv5 scores (HIV-TB screening). Participants and study staff
were not blinded to intervention allocation, but investigator blinding was
maintained until final analysis. The primary outcome was time to TB
treatment. Secondary outcomes included proportion with same-day TB
treatment; prevalence of undiagnosed/untreated bacteriologically-confirmed
TB on day 56; and undiagnosed/untreated HIV. Analysis was done on an
intention to treat basis. Cost-effectiveness analysis used a
health-provider perspective. Between 15/11/2018-27/11/2019, 8236 were
screened for eligibility, with 473, 492, and 497 randomly allocated to
SOC, HIV, and HIV-TB screening arms; 53 (11%), 52 (9%), and 47 (9%) were
lost to follow-up, respectively. At 56 days, TB treatment had been started
in 5 (1.1%) SOC, 8 (1.6%) HIV-screening, and 15 (3.0%) HIV-TB screening
participants. Median (IQR) time to TB treatment was 11 (6.5-38), 6 (1-22)
and 1 (0-3) days (hazard ratio for HIV-TB vs. SOC: 2.86, 1.04-7.87), with
same-day treatment of 0/5 (0%) SOC, 1/8 (12.5%) HIV, and 6/15 (40.0%)
HIV-TB screening arm TB patients (p=0.03). At day 56, 2 SOC (0.5%), 4 HIV
(1.0%), and 2 HIV-TB (0.5%) participants had undiagnosed
microbiologically-confirmed TB. HIV screening reduced the proportion with
undiagnosed or untreated HIV from 10 (2.7%) in the SOC arm to 2 (0.5%) in
the HIV-screening arm (risk ratio [RR]: 0.18, 0.04-0.83), and 1 (0.2%) in
the HIV-TB screening arm (RR: 0.09, 0.01-0.71). Incremental costs were
US$3.58 and US$19.92 per participant screened for HIV and HIV-TB; the
probability of cost-effectiveness at a US$1200/quality-adjusted life-year
(QALY) threshold were 83.9% and 0%. Main limitations were the lower than
anticipated prevalence of tuberculosis and short participant follow-up
period; cost and quality of life benefits of this screening approach may
accrue over a longer time horizon. DCXR-CAD with universal HIV screening
significantly increased the timeliness and completeness of HIV and TB
diagnosis. If implemented at scale this has potential to rapidly and
efficiently improve TB and HIV diagnosis and treatment.
Adults aged 18 years attending acute primary care services with symptoms
of tuberculosis (cough of any duration) and who provided informed consent
were recruited to the trial and underwent baseline questionnaire, and were
randomly allocated to one of three trial arms: standard of care; HIV
testing; or HIV testing plus digital chest x-ray screening using CAD4TBv5
(DCXR-CAD), with TB confirmatory testing by sputum Xpert. Participants
were followed for 56 days after recruitment for outcome assessment. The
primary outcome was time to TB treatment. Secondary outcomes were
proportion with same-day TB treatment; prevalence of undiagnosed/untreated
bacteriologically-confirmed TB on day 56; and undiagnosed/untreated HIV.
This dataset contains individual-level data for participants who took part
in the PROSPECT Study (clinicaltrials.gov: NCT03519425
https://clinicaltrials.gov/ct2/show/NCT03519425), a three-arm randomised
trial of computer-aided chest-xray screening and HIV testing in primary
care in Malawi. The dataset is in .csv file format. There are a total of
1462 records, each containing data on an individual trial participant.
There are a total of 21 variables, which are defined below. group: trial
arm participant was randomly allocated to: SOC: standard of care; HIV: HIV
testing; HIV-TB: HIV testing plus DCXR-CAD cough: did participant report
cough at recruitment? yes; no duration_of_cough_weeks: duration of cough
in weeks night_sweats: did participant report night sweats? yes; no
weight_loss: did participant report weight loss? yes; no fever: did
participant report fever? yes; n0 reported_hiv_status: participant's
self-reported HIV status at baseline: HIV-positive; HIV-negative; never
tested taking_antiretoviral_therapy: was participant was taking
antiretroviral therapy for treatment of HIV? yes; no
euro_qol_5q_5d_3l_zimbabwe_tariff: EuroQol EQ5D3L score (Zimbabwe tariff),
measured at baseline cxr_done: among participants allocated to the HIV-TB
arm, was a chest x-ray done? yes; no cad4tbv5_score: CAD4TBv5 score on
digital chest x-ray (range 0-100, with higher score indicating greater
probability of pulmonary TB) cad4tbv5_above_threshold: was the CAD4TBv5
score on chest x-ray above the threshold for sputum testing (greater than
or equal to 45); yes; no sputum_xpert_done: for participants with CAD4TBv5
scores above the threshold, was a sputum Xpert test done? yes; no
sputum_xpert_result: for participants where a sputum Xpert test was done,
what was the result of the Xpert test (mtb detected: Xpert showed presence
of Mycobaterium tuberculosis) primary_outcome_tb_treatment_initiation:
primary trial outcome. Was TB treatment initiated within 56 days of
recruitment? 1=yes, 0=no primary_outcome_days_to_tb_initiation: primary
trial outcome. Days from recruitment to initiation of TB treatment, or
completion of follow-up/censoring if didn't initiate TB treatment
secondary_outcome_undiagnsed_tb: secondary trial outcome. Did participant
have undiagnosed/untreated microbiologically-confirmed TB on sputum smear,
culture or Xpert on sample taken at Day 56 outcome assessment? yes; no
secondary_outcome_same_day_tb_treatment: Secondary trial outcome. Did
participant initiate TB treatment on the same day as recruitment? yes; no
secondary_outcome_undiagnosed_hiv: Secondary outcome. Did participant have
undiagnosed or untreated HIV at Day 56 outcome assessment? yes; no
secondary_outcome_mortality: did participant die during follow-up period?
yes; no secondary_outcome_eq5d: EuroQol EQ5D3L score (Zimbabwe tariff),
measured at Day 56 outcome assessment visit