The impact of emerging safety and effectiveness evidence on the use of physician-administered drugs: the case of bevacizumab for breast cancer.

BACKGROUND: Spending on physician-administered drugs is high and uses not approved by the US Food and Drug Administration (FDA) are frequent. Although these drugs may be targets of future policy efforts to rationalize use, little is known regarding how physicians respond to emerging safety and effectiveness evidence. STUDY OBJECTIVE: We analyzed changes in bevacizumab (Avastin) use for breast cancer in response to its market launch (February 2008), 2 FDA meetings reviewing data suggesting that its risks exceed its benefits (July 2010 and June 2011), and the FDA's withdrawal of approval (November 2011). DATA: Data from a population-based audit of oncologists' prescribing (IntrinsiQ Intellidose) were used to measure the monthly number of breast cancer patients treated with bevacizumab (January 2008-April 2012). METHODS: The number of bevacizumab patients following each regulatory action was estimated using negative binomial regression, compared with patients before the first FDA meeting, adjusting for cancer stage, treatment line, patient age, and outpatient office affiliation. RESULTS: Bevacizumab use for breast cancer increased significantly after FDA approval. After all regulatory actions, there was a 65% decline (95% CI, 64%-65%) in use compared with the period before the first meeting. The largest decline was in the 6-month period after the first meeting (37%; 95% CI, 28%-47%). The rate of decline did not differ by patient or cancer characteristics and differed minimally by office affiliation. DISCUSSION: Bevacizumab use for breast cancer declined dramatically after FDA meetings and regulatory actions, a period without changes in guideline recommendations or insurance coverage. Physicians seem to be responsive to emerging evidence concerning physician-administered drug safety and effectiveness.

Garden-based interventions and early childhood health: a protocol for an umbrella review.

BACKGROUND: Garden-based interventions have the potential to impact young children's health in a number of ways, including enhancing dietary intake, increasing outdoor physical activity, diversifying the gut microbiome, and promoting general wellbeing. A number of recent systematic reviews have either included or focused on garden-based interventions for young children. However, most prior reviews including young children only focus on one health outcome or one setting, making a full summary of prior research assessing the impact of garden-based interventions nonexistent. As such, this umbrella systematic review aims to synthesize the literature on health outcomes of garden-based interventions for young children. METHODS: This protocol outlines the systematic steps we will take to conduct an umbrella review on health-related outcomes of garden-based interventions in children younger than 6 years of age. We will systematically search PubMed, PsycINFO, ERIC, CINAHL, Embase, Scopus, OVID-Agricola, and CAB Direct, including all systematic reviews and meta-analyses fitting the pre-determined inclusion/exclusion criteria. We will double screen at each phase of the review: title/abstract, full text, data extraction, and quality appraisal. We will assess the quality of included reviews using A Measurement Tool to Assess Systematic Reviews (AMSTAR 2). Based on the potential for stark variability in what how reviews report child health outcomes, we will analyze the reviews both narratively and quantitatively, reporting summary of findings tables and iteratively mapping the results. This protocol aligns with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols statement (PRISMA-P). DISCUSSION: This umbrella review aims to summarize the role that garden-based interventions play in health promotion for young children. We will focus on a number of diverse child health outcomes in an effort to comprehensively synthesize the evidence to inform future garden-based interventions, research, and policy. SYSTEMATIC REVIEW REGISTRATION: PROSPERO CRD42019106848.

Puberty Experiences of Low-Income Girls in the United States: A Systematic Review of Qualitative Literature From 2000 to 2014.

PURPOSE: Puberty is a critical period of development that lays the foundation for future sexual and reproductive health. It is essential to learn about the puberty experiences of low-income girls in the United States given their increased vulnerability to negative sexual and reproductive health outcomes. To understand the present-day puberty experiences of this population, we conducted a qualitative systematic review. METHODS: We systematically searched the peer-reviewed literature published between 2000 and 2014 on the puberty experiences of low-income girls in the United States. Reviewers screened titles, abstracts, and the full texts of articles. Using standardized templates, reviewers assessed the methodologic quality and extracted data. Data were synthesized using thematic analysis. Confidence in each finding was assessed using Confidence in the Evidence from Reviews of Qualitative research. RESULTS: Twenty qualitative articles were included. They described the experiences of mostly African-American, Caucasian, and Hispanic girls living primarily in urban areas of Northeastern United States. Five overarching themes emerged: content of girls' puberty experiences, quality of girls' puberty experiences, messages girls receive about puberty, other factors that shape girls' puberty experiences, and relationships that shape girls' experiences of puberty. CONCLUSIONS: The limited existing evidence suggests that low-income girls in the United States are unprepared for puberty and have largely negative experiences of this transition.

"Let Me Help You Help Me": Church-Based HIV Prevention for Young Black Men Who Have Sex With Men.

The goal of this study was to identify strategies that could yield more inclusive church-based HIV prevention efforts. In-depth interviews were conducted with 30 young Black men who have sex with men (YBMSM) living in Baltimore, Maryland. The sample had an equal number of regular and infrequent church attendees. Nearly one-fourth of the sample was HIV-positive. Interviews were transcribed verbatim and analyzed inductively using a qualitative content analytic approach. Two main recommendations emerged for churches to offer more inclusive HIV prevention efforts: (1) reduce homosexuality stigma by increasing interpersonal and institutional acceptance, and (2) address the sexual health needs of all congregants by offering universal and targeted sexual health promotion. Thus, results support a tiered approached to providing more inclusive church-based HIV prevention efforts. We conclude that Black churches can be a critical access point for HIV prevention among YBMSM and represent an important setting to intervene.

Understanding Factors that Shape Gender Attitudes in Early Adolescence Globally: A Mixed-Methods Systematic Review.

BACKGROUND: Early adolescence (ages 10-14) is a period of increased expectations for boys and girls to adhere to socially constructed and often stereotypical norms that perpetuate gender inequalities. The endorsement of such gender norms is closely linked to poor adolescent sexual and reproductive and other health-related outcomes yet little is known about the factors that influence young adolescents' personal gender attitudes. OBJECTIVES: To explore factors that shape gender attitudes in early adolescence across different cultural settings globally. METHODS: A mixed-methods systematic review was conducted of the peer-reviewed literature in 12 databases from 1984-2014. Four reviewers screened the titles and abstracts of articles and reviewed full text articles in duplicate. Data extraction and quality assessments were conducted using standardized templates by study design. Thematic analysis was used to synthesize quantitative and qualitative data organized by the social-ecological framework (individual, interpersonal and community/societal-level factors influencing gender attitudes). RESULTS: Eighty-two studies (46 quantitative, 31 qualitative, 5 mixed-methods) spanning 29 countries were included. Ninety percent of studies were from North America or Western Europe. The review findings indicate that young adolescents, across cultural settings, commonly express stereotypical or inequitable gender attitudes, and such attitudes appear to vary by individual sociodemographic characteristics (sex, race/ethnicity and immigration, social class, and age). Findings highlight that interpersonal influences (family and peers) are central influences on young adolescents' construction of gender attitudes, and these gender socialization processes differ for boys and girls. The role of community factors (e.g. media) is less clear though there is some evidence that schools may reinforce stereotypical gender attitudes among young adolescents. CONCLUSIONS: The findings from this review suggest that young adolescents in different cultural settings commonly endorse norms that perpetuate gender inequalities, and that parents and peers are especially central in shaping such attitudes. Programs to promote equitable gender attitudes thus need to move beyond a focus on individuals to target their interpersonal relationships and wider social environments. Such programs need to start early and be tailored to the unique needs of sub-populations of boys and girls. Longitudinal studies, particularly from low-and middle-income countries, are needed to better understand how gender attitudes unfold in adolescence and to identify the key points for intervention.