Immunogenicity and Safety of Hepatitis B Virus (HBV) Vaccine With a Toll-Like Receptor 9 Agonist Adjuvant in HBV Vaccine-Naïve People With Human Immunodeficiency Virus.

In this international, multicenter open-label study (ACTG A5379) of HepB-CpG vaccine in people with human immunodeficiency virus (HIV) without prior hepatitis B virus (HBV) vaccination, all 68 participants achieved HBV seroprotective titers after the 3-dose series in the primary analysis. No unexpected safety issues were observed.

Measuring and paying for quality of care in performance-based financing: Experience from seven low and middle-income countries (Democratic Republic of Congo, Kyrgyzstan, Malawi, Mozambique, Nigeria, Senegal and Zambia).

BACKGROUND: Performance-based financing (PBF) both measures and determines payments based on the quality of care delivered and is emerging as a potential tool to improve quality. METHODS: Comparative case study methodology was used to analyze common challenges and lessons learned in quality of care across seven PBF programs (Democratic Republic of Congo, Kyrgyzstan, Malawi, Mozambique, Nigeria, Senegal and Zambia). The eight case studies, across seven PBF programs, compared were commissioned by the USAID-funded Translating Research into Action (TRAction) project (n = 4), USAID's Health Finance and Government project (n = 3), and from the Global Delivery Initiative (n = 1). RESULTS: The programs show similar design features to assess quality, but significant heterogeneity in their application. The seven programs included 18 unique quality checklists, containing over 1400 quality of care indicators, with an average per checklist of 116 indicators (ranging from 26-228). The quality checklists share a focus on structural components of quality (representing 80% of indicators on average, ranging from 38%-91%). Process indicators constituted an average of 20% across all checklists (ranging from 8.4% to 61.5%), with the majority measuring the correct application of care protocols for MCH services including child immunization. The sample included only one example of an outcome indicator from Kyrgyzstan. Performance data demonstrated a modest upward improvement over time in checklist scores across schemes, however, achievements plateaued at 60%-70%, with small or rural clinics reporting difficulty achieving payment thresholds due to limited resources and poor infrastructure. Payment allocations (distribution) and thresholds (for payments), data transparency, and approaches to measuring (verification) of quality differ across schemes. CONCLUSIONS: Similarities exist in the processes that govern the design of PBF mechanisms, yet substantial heterogeneity in the experiences of implementing quality of care components in PBF programs are evident. This comparison suggests tailoring further the quality component of PBF programs to local and country contexts, and a need to better understand how quality is measured in practice. The growing operational experiences with PBF programs in different settings offer opportunities to learn from best practices, improve ongoing and future programs, and inform research to alleviate current challenges.

Patient-reported Symptoms of Tenosynovial Giant Cell Tumors.

PURPOSE: Tenosynovial giant cell tumor (TGCT), a rare locally aggressive neoplasm of the synovium of joints and tendon sheaths, is associated with joint destruction, inflammation, pain, and swelling, in part due to colony-stimulating factor 1 receptor-bearing macrophages recruited to the tumor by genetic elevation of colony-stimulating factor 1 activity. The most common treatment is surgery, although promising pharmacologic treatments are in development. Patient-reported outcome (PRO) instruments are critical end points in demonstrating the clinical relevance of standard oncologic outcome measures and the overall impact of novel pharmacologic therapies in nonmalignant neoplastic conditions such as TGCT. The content validity of PROs relevant to patients with TGCT has not been formally investigated, and instruments to evaluate such outcomes do not exist for this condition. METHODS: PRO instruments of potential relevance were evaluated by using a literature review and by clinical and PRO experts. Patients with TGCT were recruited through clinical sites and the Internet for participation in qualitative research interviews to identify predominant symptoms and to test the relevance and content validity of several PRO measures. Select PRO measures were included in a Phase I clinical trial, and preliminary results of the PRO end points are reported descriptively. FINDINGS: Of the 22 subjects who participated in qualitative interviews, 73% were female, and their mean age was 42.5 years (range, 27-56 years). The TGCTs (19 diffuse and 3 localized) were located in the knee (n = 15), hip (n = 3), ankle (n = 2), elbow (n = 1), and forearm (n = 1). The most common symptoms cited were pain (82%), swelling (86%), stiffness (73%), reduced range of motion (64%), and joint instability (64%), which were consistent with clinical expert input and with the content of instruments chosen by PRO experts. The worst pain numeric rating scale, Patient Reported Outcomes Measurement Information System physical functioning items, and the Western Ontario and McMaster Universities Osteoarthritis Index, as well as a worst stiffness numeric rating scale developed for TGCT, were confirmed as meaningful measures of TGCT patient symptoms and were well understood in qualitative interviews. Results from the Phase I trial showed trends of improvement in both pain and stiffness over time. IMPLICATIONS: This study is the first to gather information directly from patients with TGCT regarding their symptom experiences. Pain, stiffness, and physical functioning are important treatment outcomes in patients with TGCT. We have identified content-valid PRO measures of these concepts, which are included in an ongoing Phase III TGCT clinical trial with pexidartinib (PLX3397) (NCT02371369).