Patient-reported usability and satisfaction with electronic medication event reminder and monitor device for tuberculosis: a multicentre, randomised controlled trial.

Background: The success of a tuberculosis digital adherence technology relies on patients' satisfaction with and the usability of the technology. This study aimed to evaluate treatment satisfaction and usability of a digital medication event reminder and monitor (MERM) device for patients with tuberculosis to address the prespecified secondary endpoint of the SELFTB trial. Methods: In this multicenter, randomised controlled trial, adults (≥18 years) with new or previously treated, bacteriologically-confirmed, drug-sensitive pulmonary tuberculosis who were eligible to start anti-tuberculosis therapy were recruited from 10 healthcare facilities in Ethiopia. With a computer-generated random number sequence, participants were randomly assigned 1:1 to receive a 15-day tuberculosis medication supply dispensed with an evriMED500® MERM device to self-administer and return every 15 days or the standard in-person DOT. Both arms were followed throughout the standard two-month intensive treatment phase. Treatment was based on the WHO-recommended two-month fixed-dose-combination of first-line anti-tuberculosis drug delivered as a single daily dose (2RHZE). Treatment Satisfaction Questionnaire for Medication version 4 (TSQM 1.4©) was used to measure and compare treatment satisfaction between arms. Adapted System Usability Scale (SUS) was used to assess the usability of the device, with emphasis on ease of use, challenges, benefits, motivation, popularity, and recommendation. The findings were correlated with adherence and clinical endpoints including sputum smear conversion and IsoScreen urine isoniazid test results. This trial is registered with ClinicalTrials.gov, NCT04216420. Findings: Between June 2, 2020, and June 15, 2021, 337 patients were screened for eligibility, of whom 109 participants enrolled and completed the satisfaction [control (n = 57) and intervention (n = 52) arms] and usability [intervention arm (n = 52)] questionnaires. TSQM 1.4© geometric mean scores were: Effectiveness 73.25 [geometric standard deviation (GSD) 1.28], Side Effects 100, Convenience 63.31 (GSD 1.45), and Global Satisfaction 77.29 (GSD 1.25). TSQM score was significantly higher in the intervention vs the control: Effectiveness [85.78 vs 63.43, 95% CI 1.35 (1.26-1.45), p < 0.001], Convenience [85.41 vs 48.18, 95% CI 1.77 (1.63-1.93), p < 0.001], and Global Satisfaction [90.19 vs 67.11, 95% CI 1.34 (1.26-1.43), p < 0.001]. There were significant associations between Global Satisfaction and medication adherence (p = 0.017). Average SUS score was 97.45%, which was close to the best imaginable SUS value of 100%. Likelihood to Recommend (LTR) value was ≥9, on a scale of 0-10, for 90.4% of MERM users, yielding higher net promoters. There was no significant association between usability and medication adherence (p = 0.691). Interpretation: Our findings suggested that treatment satisfaction scores were superior in the intervention vs control arms and across the domains of Effectiveness, Convenience, and Global Satisfaction. There was excellent usability of the MERM device and a significantly higher number of users likely to promote the device. High tuberculosis burden countries may transform patient-centered care through ongoing evaluation and scale-up of digital health innovations. Funding: U.S. National Institute of Health (NIH) Fogarty International Center and National Institute of Allergy and Infectious Diseases (D43 TW009127) and the Emory Center for AIDS Research (P30 AI050409).

Clean and Safe Healthcare Environment: Knowledge, Attitude, and Practice of Infection Prevention and Control among Health Workforce at North Showa Zone Oromiya Region.

Background: Infection prevention and control practice (IPCP) is essential for healthcare safety and quality service delivery. The Ethiopian government has already put in place programs and initiatives for clean and safe healthcare facilities. However, in the North Showa Zone of the Oromiya Region, the infection prevention and control practice level was not well understood. Therefore, this study aimed to assess the knowledge, attitude, and practice of infection prevention and control practice among the health workforce (HWF) in North Shoa healthcare facilities (NSHCFs) environment. Methods: Healthcare facility-based cross-sectional study design was employed. Structured and pretested self-administered questionnaires were distributed for 373 health workforce. Three hospitals and six health centers were randomly selected, and the study participants were selected by systematic sampling technique. Data were entered into Epi-data version 3.5.2 and then exported to SPSS version 23 for analysis. Multivariable logistic regression was performed to determine the associated factors with infection prevention practice, and a p value of less than 0.05 was considered statistically significant. Results: A total of 361 (96.8%) health workforce responded to self-administered questionnaires. About 55.70% of study participants had good knowledge, 59.3% of them had a positive attitude, and 46.8% had a good infection prevention practice. Age category of 20-29(AOR = 4.08, 95%, CI = (1.97, 8.49)), female participants (AOR = 3.87, 95%, CI = (1.91, 7.86)), single participants (AOR = 3.89, 95%, CI = (1.92, 7.87)), having greater than ten years of working experience (AOR = 3.10, 95% CI = (1.19, 8.10)), positive attitude (AOR = 10.07, 95% CI = (4.82, 21.05)), and availability of water at working area (AOR = 2.27, 95% CI = (1.18, 4.35)) were significantly associated with good infection prevention practice. Conclusion: In this study, a significant number of health workers had low knowledge, negative attitudes, and poor infection prevention practices. Female participants, higher work experience, a positive attitude, and water availability in the healthcare facilities were positively associated with infection prevention and control practice. Healthcare facilities should be continued capacitating the health workforce on infection prevention and control measures and equipping health facilities with infection prevention materials.

Is directly observed tuberculosis treatment strategy patient-centered? A mixed method study in Addis Ababa, Ethiopia.

INTRODUCTION: The directly observed treatment, short course (DOTS) strategy has been considered as an efficacious approach for better tuberculosis (TB) treatment adherence and outcome. However, its level of patient centerdness has not been studied and documented well. Hence, the study aimed to determine the level of patient centeredness' of the DOTS. METHOD: The study used explanatory sequential mixed method design in Addis Ababa, Ethiopia. The study employed an interviewer-administered questionnaire with 601 patients with TB, focus group discussions with 23 TB experts, and telephonic-interview with 25 persons lost to follow-up from TB treatment. Descriptive and multivariable analyses carried out for the quantitative data while thematic analysis was used for the qualitative data. RESULT: Forty percent of patients with TB had not received patient-centered TB care (PC-TB care) with DOTS. Male gender (AOR = 0.45, 95% CI 0.3, 0.7), good communication (AOR = 3.2, 95%CI 1.6, 6.1), and health care providers as a treatment supporter (AOR = 3.4, 95% CI 2.1, 5.48) had significant associations with PC-TB care. All persons lost to follow-up and TB experts perceived that DOTS is merely patient-centered. The identified categories were patient preferences, treatment supporter choice, integration of DOTS with nutritional support, mental health, and transport services, provider's commitment and communication skills. CONCLUSION: DOTS is limited to provide patient-centered TB care. Hence, DOTS needs a model that enhances effectiveness towards patient centeredness of TB care.

Satisfaction of patients with directly observed treatment strategy in Addis Ababa, Ethiopia: A mixed-methods study.

BACKGROUND: Directly observed treatment, short course (DOTS) strategy has been a cornerstone for Tuberculosis (TB) control programs in developing countries. However, in Ethiopia satisfaction level of patients' with TB with the this strategy is not well understood. Therefore, the study aimed to assess the satisfaction level of patients with TB with the DOTS. METHOD: Explanatory sequential mixed method design was carried out in Addis Ababa, Ethiopia. Interviewer-administered questionnaire with 601 patients with TB who were on follow-up was employed in the quantitative approach. In the qualitative approach telephonic-interview with 25 persons lost to follow-up and focus group discussions with 23 TB experts were conducted. RESULT: Sixty seven percent of respondent was satisfied with the DOTS. Rural residency (AOR = 3.4, 95% CI 1.6, 7.6), having TB symptoms (AOR = 0.6, 95% CI 0.4, 0.94) and treatment supporter (AOR = 4.3, 95%CI 2.7, 6.8) were associated with satisfaction with DOTS. In qualitative finding, all persons lost to follow-up were dissatisfied while TB experts enlightened lack of evidence to affirm the satisfaction level of patients with DOTS. Explored factors contributing to satisfaction include: on time availability of health care providers, DOTS service delivery process, general condition of health care facilities, nutritional support and transportation. CONCLUSION: DOTS is limited to satisfy patients with TB and lacks a consistent system that determines the satisfaction level of patients with TB. Therefore, DOTS strategy needs to have a system to captures patients' satisfaction level to respond on areas that need progress to improve DOTS service quality.

Tuberculosis care strategies and their economic consequences for patients: the missing link to end tuberculosis.

BACKGROUND: While investment in the development of Tuberculosis (TB) treatment strategies is essential, it cannot be assumed that the strategies are affordable for TB patients living in countries with high economic constraints. This study aimed to determine the economic consequences of directly observed therapy for TB patients. METHODS: A cross-sectional cost-of-illness analysis was conducted between September to November 2015 among 576 randomly selected adult TB patients who were on directly observed treatment in 27 public health facilities in Addis Ababa, Ethiopia. Data were collected using interviewer-administered questionnaire adapted from the Tool to Estimate Patients' Costs. Mean and median costs, reduction of productivity, and household expenditure of TB patients were calculated and ways of coping costs captured. Eta (η), Odds ratio and p values were used to measure association between variables. RESULTS: Of the total 576 TB patients enrolled, 43 % were smear-positive pulmonary TB (PTB), 17 % smear-negative PTB, 37 % Extra-PTB and 3 % multi-drug resistant TB cases. Direct (Out-of-Pocket) mean and median costs of TB illness to patients were $123.0 (SD = 58.8) and $125.78 (R = 338.12), respectively, and indirect (loss income) mean and median costs were $54.26 (SD = 43.5) and $44.61 (R = 215.6), respectively. Mean and median total cost of TB illness to patient were $177.3 (SD = 78.7) and $177.1 (R = 461.8), respectively. The total cost had significant association with patient's household income, residence, need for additional food, and primary income (P <0.05). Direct costs were catastrophic for 63 % of TB patients, regardless of significant difference between gender (P = 0.92) and type of TB cases (P = 0.37). TB patients mean productivity and income reduced by 37 and 10 %, respectively, compared with pre-treatment level, while mean household expenditure increased by 33 % and working hours reduced by 78 % due to TB illness. Income quartile categories were directly correlated with catastrophic costs (η = 0.684). CONCLUSION: Despite the availability of free-of-charge anti-TB drugs, TB patients were suffering from out-of-pocket payments with catastrophic consequences, which in turn were hampering the efforts to end TB. TB patients in resource-limited countries deserve integrated patient-centered care with comprehensive health insurance coverage, financial incentives, and nutrition support to reduce catastrophic costs and retain them in care. Such countries should induce home-based directly observed therapy programs to reduce costs due to attending health facilities, intensify home treatment of critically-ill patients with impaired mobility, and reduce the spread of TB due to patients traveling to seek care.

Treatment outcome of tuberculosis patients under directly observed treatment in Addis Ababa, Ethiopia

BACKGROUND: Tuberculosis is one of the leading causes of mortality among infectious diseases worldwide. For effective tuberculosis control, it is a pre-requisite to detect the cases as early as possible, and to ensure that the tuberculosis patients complete their treatment and get cured. However, in many resource-constrained settings treatment outcome for tuberculosis has not been satisfactory. OBJECTIVE: The aim of the study was to assess the treatment outcome of tuberculosis patients and investigate the association of demographic and clinical factors with treatment success of patients enrolled in Directly Observed Treatment Short Course program in government owned health centers over the course of five consecutive years in Addis Ababa, Ethiopia. METHODS: A register based historical cohort study covering the period of July 2004 to June 2009 was conducted to determine the treatment outcome of Directly Observed Treatment Short Course in government owned health centers in Addis Ababa. Sex and age of tuberculosis patients, health center at which the patient was treated, year of treatment, type of tuberculosis for which the patient was treated, type of treatment offered to the patient, follow-up status and documented treatment outcome were extracted from the Directly Observed Treatment Short Course clinics of three randomly selected health centers. RESULT: Records of 6450 registered tuberculosis patients (n = 3147 males and 3433 females) were included in this document review. Of these patients 18.1% were reported as being cured, 64.6% were documented as treatment completed, 3.7% died during follow-up, 5.1% were reported as defaulters, 0.4% were documented as treatment failure and 8.2% were transferred out to another health institution. Treatment center and year of enrollment were significantly associated with treatment success. CONCLUSION: Year of enrollment and treatment center were significantly associated with treatment success. Although the overall treatment success obtained in this study is in line with the World Health Organization (WHO) target, continuous follow-up of patients with frequent supportive supervision during the course of treatment, and further investigate the cause for the observed difference in treatment success across treatment centers are recommended.

Treatment outcome of tuberculosis patients under directly observed treatment in Addis Ababa, Ethiopia.

BACKGROUND: Tuberculosis is one of the leading causes of mortality among infectious diseases worldwide. For effective tuberculosis control, it is a pre-requisite to detect the cases as early as possible, and to ensure that the tuberculosis patients complete their treatment and get cured. However, in many resource-constrained settings treatment outcome for tuberculosis has not been satisfactory. OBJECTIVE: The aim of the study was to assess the treatment outcome of tuberculosis patients and investigate the association of demographic and clinical factors with treatment success of patients enrolled in Directly Observed Treatment Short Course program in government owned health centers over the course of five consecutive years in Addis Ababa, Ethiopia. METHODS: A register based historical cohort study covering the period of July 2004 to June 2009 was conducted to determine the treatment outcome of Directly Observed Treatment Short Course in government owned health centers in Addis Ababa. Sex and age of tuberculosis patients, health center at which the patient was treated, year of treatment, type of tuberculosis for which the patient was treated, type of treatment offered to the patient, follow-up status and documented treatment outcome were extracted from the Directly Observed Treatment Short Course clinics of three randomly selected health centers. RESULT: Records of 6450 registered tuberculosis patients (n=3147 males and 3433 females) were included in this document review. Of these patients 18.1% were reported as being cured, 64.6% were documented as treatment completed, 3.7% died during follow-up, 5.1% were reported as defaulters, 0.4% were documented as treatment failure and 8.2% were transferred out to another health institution. Treatment center and year of enrollment were significantly associated with treatment success. CONCLUSION: Year of enrollment and treatment center were significantly associated with treatment success. Although the overall treatment success obtained in this study is in line with the World Health Organization (WHO) target, continuous follow-up of patients with frequent supportive supervision during the course of treatment, and further investigate the cause for the observed difference in treatment success across treatment centers are recommended.

Mortality and associated risk factors in a cohort of tuberculosis patients treated under DOTS programme in Addis Ababa, Ethiopia.

BACKGROUND: Tuberculosis (TB) is the leading cause of mortality among infectious diseases worldwide. Ninty five percent of TB cases and 98% of deaths due to TB occur in developing countries. Globally, the mortality rate has declined with the introduction of effective anti TB chemotherapy. Nevertheless, some patients with active TB still die while on treatment for their disease. In Ethiopia, little is known on survival and risk factors for mortality among a cohort of TB patients. The objective of the study is to determine the magnitude and identify risk factors associated with time to death among TB patients treated under DOTS programme in Addis Ababa, Ethiopia. METHODS: This is a retrospective cohort study. Data was obtained by assessing medical records of TB patients registered from June 2004 to July 2009 G.C and treated under the DOTS strategy in three randomly selected health centers. A step-wise multivariable Cox's regression model and Kaplan- Meier curves were used to model the outcome of interest. Mortality was used as an outcome measure. Person-years of observation (PYO) were calculated from the date of starting anti-TB treatment to date of outcome and was calculated as the number of deaths/100 PYO. Statistical analysis SPSS version 16 was used for data analysis and results were reported significant whenever P-value was less than 5%. RESULTS: From a total of 6,450 registered TB patients 236(3.7%) were died. More than 75% death occurred within eight month of treatment initiation. The mean and median times of survival starting from the date of treatment initiation were 7.2 and 7.9 months, respectively. Comparison of survival curves using Kaplan Meier curves method with log-rank test showed that the survival status was significantly different between patient categories as well as across treatment centers (P < 0.05). The death rate of pulmonary positive, pulmonary negative and extra pulmonary TB patients were 2.7%, 3.6%, and 4.3%, respectively. Body weight at initiation of anti-TB treatment (<35 kg), patient category, year of enrollment and treatment center were independent predictors for time to death. CONCLUSIONS: Most of the patients were died at the end of treatment period. This underlines the need for devising a mechanism of standardizing the existing DOTS programme and nutritional support for underweight patients for better clinical and treatment outcome.