Patient satisfaction among persons living with HIV/AIDS and receiving antiretroviral therapy in urban Uganda: A factor analysis.

INTRODUCTION: Patient satisfaction is an important predictor of health outcomes among patients in HIV/AIDS treatment and care, yet it is rarely measured in routine clinic settings in most of Africa. The aims of our study were to evaluate the internal validity and reliability of the Consumer Assessment of Healthcare Providers and Systems instrument for measuring satisfaction, assess the general level of patient satisfaction, and identify the factors associated with the level of satisfaction among patients receiving antiretroviral therapy in Uganda. MATERIALS AND METHODS: We conducted a cross-sectional study of 475 HIV/AIDS-infected patients from July to August 2015 in Kampala, Uganda. Eligible participants were 18 years or older, consented to the study and receiving antiretroviral therapy and outpatient care at the selected public health clinic. This study used a modified version of the validated Consumer Assessment of Healthcare Providers and Systems (CAHPS) instrument to assess the level of satisfaction among HIV/AIDS patients receiving outpatient care. We collected data on socio-demographics, clinical variables and 18-items adapted from the CAHPS instrument rating satisfaction with aspects of health services. We conducted an exploratory factor analysis to assess the internal validity of the 18 items and multiple linear regression analysis of factors associated with patient satisfaction with care. RESULTS: Majority of the respondents were females (76.8%), and the mean age was 37 years (SD = 10). The modified CAHPS instrument had high internal consistency (Cronbach's α = 0.94) for measuring satisfaction with HIV/AIDS care. Female sex (p = 0.016), perceived providers' technical and interpersonal skills (p = 0.022), emotional health (p = 0.032), and quality of reception services (p<0.001) were significantly associated with satisfaction in this urban HIV/AIDS public clinic. CONCLUSION: The reliability of the CAHPS instrument was high for measuring satisfaction. Providers' technical and interpersonal skills, and the quality of reception services are key to achieving patient satisfaction. Health system interventions to address the gaps identified will enhance the quality of patient-centered HIV/AIDS care in the Ugandan setting.

A Retrospective Review of Center for Biologics Evaluation and Research Advisory Committee Meetings in the Context of the FDA's Benefit-Risk Framework.

The US FDA Center for Biologics Evaluation and Research (CBER) is responsible for the regulation of biologically derived products. FDA has established Advisory Committees (AC) as vehicles to seek external expert advice on scientific and technical matters related to the development and evaluation of products regulated by the agency. We aimed to identify and evaluate common topics discussed in CBER AC meetings during the regulatory decision-making process for biological products and medical devices. We analyzed the content of 119 CBER-led AC meetings between 2009 and 2021 listed on the FDA AC webpage. We reviewed publicly available meeting materials such as briefing documents, summaries, and transcripts. Using a structured review codebook based on FDA benefit-risk guidance, we identified important considerations within the benefit-risk dimensions discussed at the AC meetings: therapeutic context, benefit, risk and risk management, and benefit-risk trade-off, where evidence and uncertainty are critical parts of the FDA benefit-risk framework. Based on a detailed review of 24 topics discussed in 23 selected AC meetings conducted between 2016 and 2021, the two most frequently discussed considerations were "Uncertainty about assessment of the safety profile" and "Uncertainty about assessment of the benefit based on clinical trial data" (16/24 times each) as defined in our codebook. Most of the reviewed meetings discussed Investigational New Drug or Biologics License Applications of products. This review could help sponsors better plan and design studies by contextualizing how the benefit-risk dimensions were embedded in the AC discussions and the considerations that went into the final AC recommendations.

Regulatory considerations for study of infant protection through maternal immunization.

Childhood Immunization is one of the critical strategies to decrease infant morbidity and mortality due to infectious diseases, but primary immunization schedules for infants in most countries start at 2 months of age. Childhood vaccines therefore begin providing adequate protection later in life, leaving infants vulnerable to infectious diseases and creating an immunity gap that results in higher morbidity and mortality among younger infants. Maternal immunization, the practice of vaccinating individuals during pregnancy, reduces the risk of infant infection primarily through the transfer of protective maternal antibodies to the fetus during late pregnancy. Although much progress has been made in public health policies to support maternal immunization research, inclusion of pregnant individuals and children in clinical trials remains challenging. This has resulted in paucity of evidence regarding safety and effectiveness of vaccines to support licensure of products intended for use during pregnancy and lactation to prevent disease in the infant. In addition, although safeguards for clinical research in pregnancy are supportive, experimental vaccines, e.g., Respiratory Syncytial Virus, are more complicated to study because data on safety, efficacy, and dosing are limited. This requires randomized controlled trials with safety monitoring for the mother, the fetus, and the infant with follow-up for at least 1 year or longer to assess long-term health outcomes that may be associated with peripartum vaccine exposure. The goal of this paper is to discuss the general regulatory considerations for clinical research to evaluate safety and effectiveness of vaccines administered during pregnancy to protect infants from disease. This could be useful to inform future vaccine trials. This discussion is not intended to provide agency guidance nor to articulate agency policy.