Implementation of Bedaquiline, Pretomanid, and Linezolid in the United States: Experience Using a Novel All-Oral Treatment Regimen for Treatment of Rifampin-Resistant or Rifampin-Intolerant Tuberculosis Disease.

BACKGROUND: Rifampin-resistant tuberculosis is a leading cause of morbidity worldwide; only one-third of persons start treatment, and outcomes are often inadequate. Several trials demonstrate 90% efficacy using an all-oral, 6-month regimen of bedaquiline, pretomanid, and linezolid (BPaL), but significant toxicity occurred using 1200-mg linezolid. After US Food and Drug Administration approval in 2019, some US clinicians rapidly implemented BPaL using an initial 600-mg linezolid dose adjusted by serum drug concentrations and clinical monitoring. METHODS: Data from US patients treated with BPaL between 14 October 2019 and 30 April 2022 were compiled and analyzed by the BPaL Implementation Group (BIG), including baseline examination and laboratory, electrocardiographic, and clinical monitoring throughout treatment and follow-up. Linezolid dosing and clinical management was provider driven, and most patients had linezolid adjusted by therapeutic drug monitoring. RESULTS: Of 70 patients starting BPaL, 2 changed to rifampin-based therapy, 68 (97.1%) completed BPaL, and 2 of the 68 (2.9%) experienced relapse after completion. Using an initial 600-mg linezolid dose daily adjusted by therapeutic drug monitoring and careful clinical and laboratory monitoring for adverse effects, supportive care, and expert consultation throughout BPaL treatment, 3 patients (4.4%) with hematologic toxicity and 4 (5.9%) with neurotoxicity required a change in linezolid dose or frequency. The median BPaL duration was 6 months. CONCLUSIONS: BPaL has transformed treatment for rifampin-resistant or intolerant tuberculosis. In this cohort, effective treatment required less than half the duration recommended in 2019 US guidelines for drug-resistant tuberculosis. Use of individualized linezolid dosing and monitoring likely enhanced safety and treatment completion. The BIG cohort demonstrates that early implementation of new tuberculosis treatments in the United States is feasible.

Primary care clinicians' perspectives about quality measurements in safety-net clinics and non-safety-net clinics.

BACKGROUND: Quality metrics, pay for performance (P4P), and value-based payments are prominent aspects of the current and future American healthcare system. However, linking clinic payment to clinic quality measures may financially disadvantage safety-net clinics and their patient population because safety-net clinics often have worse quality metric scores than non-safety net clinics. The Minnesota Safety Net Coalition's Quality Measurement Enhancement Project sought to collect data from primary care providers' (PCPs) experiences, which could assist Minnesota policymakers and state agencies as they create a new P4P system. Our research study aims are to identify PCPs' perspectives about 1) quality metrics at safety net clinics and non-safety net clinics, 2) how clinic quality measures affect patients and patient care, and 3) how payment for quality measures may influence healthcare. METHODS: Qualitative interviews with 14 PCPs (4 individual interviews and 3 focus groups) who had worked at both safety net and non-safety net primary care clinics in Minneapolis-St Paul Minnesota USA metropolitan area. Qualitative analyses identified major themes. RESULTS: Three themes with sub-themes emerged. Theme #1: Minnesota's current clinic quality scores are influenced more by patients and clinic systems than by clinicians. Theme #2: Collecting data for a set of specific quality measures is not the same as measuring quality healthcare. Subtheme #2.1: Current quality measures are not aligned with how patients and clinicians define quality healthcare. Theme #3: Current quality measures are a product of and embedded in social and structural inequities in the American health care system. Subtheme #3.1: The current inequitable healthcare system should not be reinforced with financial payments. Subtheme #3.2: Health equity requires new metrics and a new healthcare system. Overall, PCPs felt that the current inequitable quality metrics should be replaced by different metrics along with major changes to the healthcare system that could produce greater health equity. CONCLUSION: Aligning payment with the current quality metrics could perpetuate and exacerbate social inequities and health disparities. Policymakers should consider PCPs' perspectives and create a quality-payment framework that does not disadvantage patients who are affected by social and structural inequities as well as the clinics and providers who serve them.