Background
Directly observed treatment (DOT) has been the standard of care for tuberculosis
since the early 1990s, but delivery entails substantial inconvenience to patients and
service providers. Remote video observed therapy (VOT) has recently been
conditionally recommended by the WHO as an alternative to DOT. We tested
whether levels of treatment observation were improved with VOT.
Methods
We conducted a randomised controlled trial of VOT (daily remote observation using a
smartphone app) compared to DOT (three or five-weekly observation in home,
community or clinic settings). Tuberculosis patients eligible for DOT at 22 clinics in
England were allocated to trial arms by the SealedEnvelopeTM service using
randomisation by minimisation. The primary outcome was completion of 80% or more
scheduled treatment observations over the first two months following enrolment.
Intention-to-treat and restricted (including only patients with at least one week of
observation on allocated arm) analyses were conducted. The trial is registered with
the ISRCTN, number ISRCTN26184967.
Findings
Between September 1, 2014 and October 1, 2016, we enrolled 226 patients; 112
randomised to VOT and 114 to DOT. Overall, 58% (131 of 226) had a history of
homelessness, imprisonment, drug use, alcohol problems or mental health problems.
Seventy percent of patients on VOT (78 of 112) had the primary outcome compared
to 31% (35 of 114) of those on DOT (adjusted odds ratio 5·48; 95% confidence
interval 3·10-9·68; p<0·0001). Drop-out during the first week of observation was less
for VOT (10%, 11 of 112) than DOT (51%, 58 of 114). High observation levels were
sustained throughout treatment for VOT patients, but declined rapidly for DOT
patients.
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Interpretation
VOT is a more effective approach to observation of tuberculosis treatment than clinic-
, community- or home-based DOT.