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NIHR Signal Smartphones instead of direct supervision can improve adherence rates for TB treatment

Published on 11 June 2019

doi: 10.3310/signal-000777

People who need supervision take their medication for tuberculosis (TB) more reliably when using a smartphone to send video evidence instead of direct observations; for example, by attending a clinic appointment. Almost double the number of observations was completed in the video-supervised arm at six months than when people were directly observed.

Ensuring the effectiveness of treatment is central to worldwide TB control. Directly-observed treatment, in which a healthcare professional supervises a patient taking medication, is the established standard of care for those at risk of not completing the course for TB in the UK, but is not for everyone. This well-conducted NIHR-funded trial achieved good rates of supervision with video-observed treatment and showed potential for engaging populations at risk of not completing their therapy.

The study is likely to be too small to show if video-observed treatment reduced rates of TB but indicates it may have benefits for patients and clinicians. These results may support local authorities and public health practitioners in service development initiatives for TB and infection control, with the added bonus that they were cost-saving too.

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Why was this study needed?

Globally, TB accounts for 1.6 million deaths and causes disease in 10 million people annually. In the UK, the incidence of TB is highest in the most deprived sections of the population often affecting people with histories of homelessness, imprisonment, and drug or alcohol problems.

Adherence to therapy is key in TB control. For effective outcomes and reduced antimicrobial resistance, TB is treated with a full course of antibiotics taken at regular intervals for several months. This treatment is sometimes prescribed as directly-observed therapy, a well-established treatment for supervision in community and outpatient settings. Observation is reserved for those at risk of not completing treatment because they have socially complex lives or mental illness.

Direct observation can be inconvenient and costly for both patients and service providers, and remote video-observation presents an alternative that is potentially more convenient. This study aimed to identify whether it can improve levels of adherence.

What did this study do?

This randomised controlled trial included 226 patients aged over 16 years with active TB from 22 clinics in England. They were allocated to receive either standard observation or video observation. Directly observations were undertaken three to five times per week at home, community or clinical settings. Those randomised to video observation by smartphone were trained to use an app and to send video recordings of each treatment dose taken.

Over half the participants in this well-conducted study were representative of homeless and other at-risk population groups. Smartphones, the app and data plans were provided by the study investigators for the duration of the study.

What did it find?

  • 70% (78/112) of patients on video observed treatment achieved over 80% of their scheduled observations within the first two months of the study compared with 31% (35/114) on directly observed treatment: odds ratio 5.48 (95% confidence interval [CI] 3.10 to 9.68).
  • In analysis restricted to those who initially engaged with therapy (at least for the first week), video observation was still more successful, with 77% (78/101) compared with 63% (35/56) of people in the direct observation group achieving over 80% of their scheduled observations.
  • Over the six-month follow-up period, high observation rates were maintained with those on video observation but quickly decreased with those on direct observation. Scheduled observations were completed 77% of times in the video observed arm (95% CI 76 to 77) compared with 39% (95% CI 38 to 40) in the direct observation arm (p<0·0001).
  • When factoring in the cost of providing a free mobile device and data plan to all study participants, video observation saved money compared with direct observation. The costs of providing direct observation over six months were estimated at £5,700 per patient for observations five times per week, and £3,420 for observations three times per week. For daily video observation over six months, costs were estimated at £1,645 per patient.
  • The side effects of stomach pain, nausea or vomiting were reported frequently by 14% of those on video observation and 8% of those on direct observation.

What does current guidance say on this issue?

Current NICE guidelines recommend unsupervised treatment programmes for those likely to comply with therapy. The use of direct observation is recommended by both NICE and the World Health Organization for those less likely to comply. This includes individuals with socially complex lives or a mental illness.

There is a developing evidence-base for the use of video observation in improving adherence to treatment in TB. The World Health Organization has conditionally recommended it as an alternative to direct observation, but it is not yet included in UK guidelines.

What are the implications?

This study suggests video observation offers strong possibilities for achieving better outcomes in TB treatment compliance at a lower cost. It also appears to be more acceptable to patients. Following this study, video observation by smartphone was implemented in London services, the outcomes of which are awaited.

The benefits of the service are unlikely to be realised without the free provision of mobile devices and data plans, particularly to those from deprived or at-risk social situations. Indeed, 40% of the handsets were not returned on completion of treatment. Nevertheless, for the NHS, this intervention still resulted in cost savings compared with direct observation by a healthcare professional.

People with socially complex or disordered lives may still need additional encouragement to engage. Further data on the real-life implementation of this technology will help in interpreting the study outcomes.

Bibliography

NICE. Tuberculosis. NG33. London: National Institute for Health and Care Excellence; 2016.

Public Health England. Tuberculosis in England: 2018: presenting data to end of 2017. London: Public Health England; 2018.

WHO. Global tuberculosis report 2018: executive summary. Geneva: World Health Organization; 2018.

WHO. Guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update). Geneva: World Health Organization; 2017.

Why was this study needed?

Globally, TB accounts for 1.6 million deaths and causes disease in 10 million people annually. In the UK, the incidence of TB is highest in the most deprived sections of the population often affecting people with histories of homelessness, imprisonment, and drug or alcohol problems.

Adherence to therapy is key in TB control. For effective outcomes and reduced antimicrobial resistance, TB is treated with a full course of antibiotics taken at regular intervals for several months. This treatment is sometimes prescribed as directly-observed therapy, a well-established treatment for supervision in community and outpatient settings. Observation is reserved for those at risk of not completing treatment because they have socially complex lives or mental illness.

Direct observation can be inconvenient and costly for both patients and service providers, and remote video-observation presents an alternative that is potentially more convenient. This study aimed to identify whether it can improve levels of adherence.

What did this study do?

This randomised controlled trial included 226 patients aged over 16 years with active TB from 22 clinics in England. They were allocated to receive either standard observation or video observation. Directly observations were undertaken three to five times per week at home, community or clinical settings. Those randomised to video observation by smartphone were trained to use an app and to send video recordings of each treatment dose taken.

Over half the participants in this well-conducted study were representative of homeless and other at-risk population groups. Smartphones, the app and data plans were provided by the study investigators for the duration of the study.

What did it find?

  • 70% (78/112) of patients on video observed treatment achieved over 80% of their scheduled observations within the first two months of the study compared with 31% (35/114) on directly observed treatment: odds ratio 5.48 (95% confidence interval [CI] 3.10 to 9.68).
  • In analysis restricted to those who initially engaged with therapy (at least for the first week), video observation was still more successful, with 77% (78/101) compared with 63% (35/56) of people in the direct observation group achieving over 80% of their scheduled observations.
  • Over the six-month follow-up period, high observation rates were maintained with those on video observation but quickly decreased with those on direct observation. Scheduled observations were completed 77% of times in the video observed arm (95% CI 76 to 77) compared with 39% (95% CI 38 to 40) in the direct observation arm (p<0·0001).
  • When factoring in the cost of providing a free mobile device and data plan to all study participants, video observation saved money compared with direct observation. The costs of providing direct observation over six months were estimated at £5,700 per patient for observations five times per week, and £3,420 for observations three times per week. For daily video observation over six months, costs were estimated at £1,645 per patient.
  • The side effects of stomach pain, nausea or vomiting were reported frequently by 14% of those on video observation and 8% of those on direct observation.

What does current guidance say on this issue?

Current NICE guidelines recommend unsupervised treatment programmes for those likely to comply with therapy. The use of direct observation is recommended by both NICE and the World Health Organization for those less likely to comply. This includes individuals with socially complex lives or a mental illness.

There is a developing evidence-base for the use of video observation in improving adherence to treatment in TB. The World Health Organization has conditionally recommended it as an alternative to direct observation, but it is not yet included in UK guidelines.

What are the implications?

This study suggests video observation offers strong possibilities for achieving better outcomes in TB treatment compliance at a lower cost. It also appears to be more acceptable to patients. Following this study, video observation by smartphone was implemented in London services, the outcomes of which are awaited.

The benefits of the service are unlikely to be realised without the free provision of mobile devices and data plans, particularly to those from deprived or at-risk social situations. Indeed, 40% of the handsets were not returned on completion of treatment. Nevertheless, for the NHS, this intervention still resulted in cost savings compared with direct observation by a healthcare professional.

People with socially complex or disordered lives may still need additional encouragement to engage. Further data on the real-life implementation of this technology will help in interpreting the study outcomes.

Bibliography

NICE. Tuberculosis. NG33. London: National Institute for Health and Care Excellence; 2016.

Public Health England. Tuberculosis in England: 2018: presenting data to end of 2017. London: Public Health England; 2018.

WHO. Global tuberculosis report 2018: executive summary. Geneva: World Health Organization; 2018.

WHO. Guidelines for treatment of drug-susceptible tuberculosis and patient care (2017 update). Geneva: World Health Organization; 2017.

Smartphone-enabled video-observed versus directlyobserved treatment for tuberculosis: a multicentre,analyst-blinded, randomised, controlled superiority trial

Published on 21 February 2019

A Story, R Aldridge, C Smith, E Garber, J Hall, G Ferenando, L Possas, S Hemming, F Wurie, S Luchenski, Abubakar, T McHugh, P White, J Watson, M Lipman, R Garfein, A Hayward

The Lancet , 2019

Background Directly observed treatment (DOT) has been the standard of care for tuberculosis since the early 1990s, but it is inconvenient for patients and service providers. Video-observed therapy (VOT) has been conditionally recommended by WHO as an alternative to DOT. We tested whether levels of treatment observation were improved with VOT. Methods We did a multicentre, analyst-blinded, randomised controlled superiority trial in 22 clinics in England (UK). Eligible participants were patients aged at least 16 years with active pulmonary or non-pulmonary tuberculosis who were eligible for DOT according to local guidance. Exclusion criteria included patients who did not have access to charging a smartphone. We randomly assigned participants to either VOT (daily remote observation using a smartphone app) or DOT (observations done three to five times per week in the home, community, or clinic settings). Randomisation was done by the SealedEnvelope service using minimisation. DOT involved treatment observation by a health-care or lay worker, with any remaining daily doses self-administered. VOT was provided by a centralised service in London. Patients were trained to record and send videos of every dose ingested 7 days per week using a smartphone app. Trained treatment observers viewed these videos through a password-protected website. Patients were also encouraged to report adverse drug events on the videos. Smartphones and data plans were provided free of charge by study investigators. DOT or VOT observation records were completed by observers until treatment or study end. The primary outcome was completion of 80% or more scheduled treatment observations over the first 2 months following enrolment. Intention-to-treat (ITT) and restricted (including only patients completing at least 1 week of observation on allocated arm) analyses were done. Superiority was determined by a 15% difference in the proportion of patients with the primary outcome (60% vs 75%). This trial is registered with the International Standard Randomised Controlled Trials Number registry, number ISRCTN26184967. Findings Between Sept 1, 2014, and Oct 1, 2016, we randomly assigned 226 patients; 112 to VOT and 114 to DOT. Overall, 131 (58%) patients had a history of homelessness, imprisonment, drug use, alcohol problems or mental health problems. In the ITT analysis, 78 (70%) of 112 patients on VOT achieved ≥80% scheduled observations successfully completed during the first 2 months compared with 35 (31%) of 114 on DOT (adjusted odds ratio [OR] 5·48, 95% CI 3·10–9·68; p<0·0001). In the restricted analysis, 78 (77%) of 101 patients on VOT achieved the primary outcome compared with 35 (63%) of 56 on DOT (adjusted OR 2·52; 95% CI 1·17–5·54; p=0·017). Stomach pain, nausea, and vomiting were the most common adverse events reported (in 16 [14%] of 112 on VOT and nine [8%] of 114 on DOT). Interpretation VOT was a more effective approach to observation of tuberculosis treatment than DOT. VOT is likely to be preferable to DOT for many patients across a broad range of settings, providing a more acceptable, effective, and cheaper option for supervision of daily and multiple daily doses than DOT. Funding National Institute for Health Research.

Expert commentary

This approach holds promise for establishment and maintenance of communication with hard to reach groups of patients without being intrusive or controlling by empowering the patient to demonstrate adherence without having to interact with a monitoring person.

This method can be used in services for people, who prefer not to host the visit of a health care worker or family member whose presence may be perceived as humiliating and infringing on dignity when the home environment or personal appearance is not inviting and causing embarrassment.

Future trials adequately sized to be able to demonstrate a meaningful difference in treatment outcomes like cure or relapse by employing this approach for the entire duration of treatment will show whether it actually makes a difference beyond just perception.

Michael Eisenhut, Consultant Paediatrician, Luton and Dunstable University Hospital NHS Foundation Trust; Paediatric Lead for the tuberculosis service for children in Bedfordshire, Hertfordshire and Buckinghamshire; Editor of the Cochrane Infectious Diseases Group (Cochrane Collaboration)

The commentator declares no conflicting interests

Expert commentary

Video instead of directly observed treatment for TB? A randomised controlled trial suggests that a video of swallowing TB meds sent by mobile phone is better than direct observation. It appears to have better uptake, and people may feel more at ease to mention adverse effects. In the UK, such supervision is not routine, and both forms of observation may be as difficult in those with chaotic or busy lifestyles. The hard to treat may still benefit from a more personal approach. 

Graham Bothamley, Honorary Professor and Consultant Physician, Homerton University Hospital, QMUL and London School of Hygiene and Tropical Medicine