ABSTRACT
Background: Digital adherence technologies hold promise to improve patient-centered tuberculosis (TB) monitoring, yet few studies have incorporated direct adherence monitoring or assessed patients' experiences with these technologies. We explored acceptability, feasibility, and refinement needs of the TB Treatment Support Tools (TB-TSTs) intervention linking a mobile app, a urine drug metabolite test, and interactive communication with a treatment supporter. Methods: This pilot study was a parallel-designed single-center randomized controlled trial with exit interviews. Newly diagnosed TB patients were randomized 1:1 using a treatment allocation button in the REDCap software preloaded with a random allocation sequence to usual care or usual care plus the TB-TSTs intervention from a respiratory medicine hospital in the province of Buenos Aires, Argentina and followed for 6-months. Due to the nature of the intervention, blinding to the group allocation could not be achieved for the recruiter or patients. The treatment outcome data extractor was blinded to the group allocation of the participants. Intervention participants used the app to report self-administering medication, potential side effects, submit photos of the urine test, and interact with a treatment supporter. Outcomes were feasibility, acceptability, and treatment outcomes. Findings: Forty-two patients were enrolled and evenly assigned to each group. Intervention participants submitted 147·2±58 (mean, SD) medication self-administration and 144·5±55 side effect reports out of 180 and 47.5±38·4 photos of the urine test out of 77. Treatment success for usual care was 81% [17/21] and 95% [20/21] for the TB-TSTs intervention. Thirty-three themes were identified within the main categories of motivation, what worked, issues experienced, and recommendations. Participants (n=12) rated it as 'easy to use' (4.57/5), 'would highly recommend to others' (4·43/5) and reported that access to the treatment support was a critical component. Recommendations included adding an alarm, appointment reminders, and off-line functionality. Interpretation: Findings suggest that the TB-TSTs intervention was feasible and acceptable and further refinement and testing is warranted. Funding: National Institute of Health K23NR017210.
ABSTRACT
Regulatory Decree 170/91 of Law 10436 created a legal framework designed to ensure the socio-economic protection of patients suffering from TB. It consisted of the monthly payment of a minimum salary for employees in the local public administration. The evaluation criteria employed by the health team assessed who could be included in the protection law, their social situation and permanent residence of at least two years in the province of Buenos Aires, Argentina. The aim of our study was to analyze the differences in clinical and epidemiological data between patients included in the law and those not included, and whether the benefit was a factor in the outcome of the treatment. We describe a retrospective observational study that took place from January 1, 2004 to December 31, 2016. People receiving the benefit showed a good outcome in 93.1% of the total cases, 91.1% in confirmed lung cases, 83.7% in the TB-HIV association / AIDS and 81.5% in MDR-TB. In patients not receiving the benefit the success rates were 74.4%, 73.9%, 53.6% and 58.9%, respectively. The differences were statistically significant between both groups. The economic protection law was essential in motivating the patients and in following those cases of difficult management, thus improving treatment adherence. Overcoming TB means not only improving the use of current tools and interventions but also considering the possibility of extending or approving similar laws in Argentina.
Mediante la aprobación del Decreto Reglamentario 170/91 de la Ley 10436, se crea un régimen de amparo, destinado a asegurar la protección socioeconómica del paciente afectado de tuberculosis (TB). Consiste en el pago mensual de un salario básico de la administración pública provincial. El equipo de salud es el que evalúa quiénes se encuentran en condiciones de ser incluidos en la ley de amparo. Los criterios de evaluación contemplan la situación social y una residencia permanente, como mínimo de dos años en la Provincia de Buenos Aires. El objetivo de nuestro estudio es analizar las diferencias de los datos clínicos y epidemiológicos entre pacientes con y sin inclusión en el régimen de amparo y si el subsidio fue factor de éxito en el tratamiento. Este es un estudio observacional retrospectivo, realizado entre el 1º de enero de 2004 al 31 de diciembre de 2016. Las personas con subsidio mostraron éxito en 93.1% en el total de los casos, 91.1% en los casos pulmonares confirmados, 83.7% en la asociación TB-VIH/SIDA y 81.5% en tuberculosis multirresistente (MDR-TB). Sin subsidio el éxito fue 74.4%, 73.9%, 53.6% y 58.9% respectivamente. Las diferencias fueron estadísticamente significativas entre ambos grupos. El régimen de amparo económico, fue primordial para motivar y retener los casos de difícil manejo, mejorando la adhesión al tratamiento. Poner fin a la TB, consistirá, en mejorar el uso de las herramientas e intervenciones actuales y considerar la posibilidad de extender o aprobar leyes similares en el ámbito de nuestro país.
