Four-Month High-Dose Rifampicin Regimens for Pulmonary Tuberculosis.

BACKGROUND: Shorter but effective tuberculosis treatment regimens would be of value to the tuberculosis treatment community. High-dose rifampicin has been associated with more rapid and secure lung sterilization and may enable shorter tuberculosis treatment regimens. METHODS: We randomly assigned adults who were given a diagnosis of rifampicin-susceptible pulmonary tuberculosis to a 6-month control regimen, a similar 4-month regimen of rifampicin at 1200 mg/d (study regimen 1 [SR1]), or a 4-month regimen of rifampicin at 1800 mg/d (study regimen 2 [SR2]). Sputum specimens were collected at regular intervals. The primary end point was a composite of treatment failure and relapse in participants who were sputum smear positive at baseline. The noninferiority margin was 8 percentage points. Using a sequence of ordered hypotheses, noninferiority of SR2 was tested first. RESULTS: Between January 2017 and December 2020, 672 patients were enrolled in six countries, including 191 in the control group, 192 in the SR1 group, and 195 in the SR2 group. Noninferiority was not shown. Favorable responses rates were 93, 90, and 87% in the control, SR1, and SR2 groups, respectively, for a country-adjusted absolute risk difference of 6.3 percentage points (90% confidence interval, 1.1 to 11.5) comparing SR2 with the control group. The proportions of participants experiencing a grade 3 or 4 adverse event were 4.0, 4.5, and 4.4% in the control, SR1, and SR2 groups, respectively. CONCLUSIONS: Four-month high-dose rifampicin regimens did not have dose-limiting toxicities or side effects but failed to meet noninferiority criteria compared with the standard 6-month control regimen for treatment of pulmonary tuberculosis. (Funded by the MRC/Wellcome Trust/DFID Joint Global Health Trials Scheme; ClinicalTrials.gov number, NCT02581527.)

Practice, perceived barriers and motivating factors to medical-incident reporting: a cross-section survey of health care providers at Mbarara regional referral hospital, southwestern Uganda.

BACKGROUND: Medical-incident reporting (MIR) ensures patient safety and delivery of quality of care by minimizing unintentional harm among health care providers. We explored medical-incident reporting practices, perceived barriers and motivating factors among health care providers at Mbarara Regional Referral Hospital (MRRH). METHODS: We conducted a cross-sectional descriptive study on 158 health provider at Mbarara Regional Referral Hospital (MRRH), Western Uganda. Data was gathered using a structured questionnaire and analyzed with SPSS. The chi-square was used to determine factors associated with MIR at MRRH. RESULTS: The results showed that there was no formal incident reporting structure. However the medical-incidences identified were: medication errors (89.9%), diagnostic errors (71.5%), surgical errors (52.5%) and preventive error (47.7%). The motivating factors of MIR were: establishment of a good communication system, instituting corrective action on the reported incidents and reinforcing health workers knowledge on MIR (p-value 0.004); presence of effective organizational systems like: written guidelines, practices of open door policy, no blame approach, and team work were significantly associated with MIR (p-value 0.000). On the other hand, perceived barriers to MIR were: lack of knowledge on incidents and their reporting, non-existence of an incident reporting team and fear of being punished (p- value 0.669). CONCLUSION: Medical Incident Reporting at MRRH was sub-optimal. Therefore setting up an incident management team and conducting routine training MIR among health care workers will increase patient safety.