Craig F. Garfield

Impact of FDA drug risk communications on health care utilization and health behaviors: A systematic review

Objective:To review literature on the impact of The Food and Drug Administration (FDA) drug risk communications on medication utilization, health care services use, and health outcomes. Data Sources:The authors searched MEDLINE and the Web of Science for manuscripts published between January 1990 and November 2010 that included terms related to drug utilization, the FDA, and advisories or warnings. We manually searched bibliographies and works citing selected articles and consulted with experts to guide study selection. Study Selection:Studies were included if they involved an empirical analysis evaluating the impact of an FDA risk communication. Data Extraction:We extracted the drug(s) analyzed, relevant FDA communication(s), data source, analytical method, and main outcome(s) assessed. Results:Of the 1432 records screened, 49 studies were included. These studies covered 16 medicines or therapeutic classes; one third examined communications regarding antidepressants. Most used medical or pharmacy claims and a few rigorously examined patient-provider communication, decision making, or risk perceptions. Advisories recommending increased clinical or laboratory monitoring generally led to decreased drug use, but only modest, short-term increases in monitoring. Communications targeting specific subpopulations often spilled over to other groups. Repeated or sequential advisories tended to have larger but delayed effects and decreased incident more than prevalent use. Drug-specific warnings were associated with particularly large decreases in utilization, although the magnitude of substitution within therapeutic classes varied across clinical contexts. Conclusions:Although some FDA drug risk communications had immediate and strong impacts, many had either delayed or had no impact on health care utilization or health behaviors. These data demonstrate the complexity of using risk communication to improve the quality and safety of prescription drug use, and suggest the importance of continued assessments of the effect of future advisories and label changes. Identifying factors that are associated with rapid and sustained responses to risk communications will be important for informing future risk communication efforts.

Trends in Attention Deficit Hyperactivity Disorder Ambulatory Diagnosis and Medical Treatment in the United States, 2000-2010

OBJECTIVES Because of several recent clinical and regulatory changes regarding attention deficit-hyperactivity disorder (ADHD) in the United States, we quantified changes in the diagnosis of ADHD and its pharmacologic treatment from 2000 through 2010. METHODS We used the IMS Health National Disease and Therapeutic Index, a nationally representative audit of office-based providers, to examine aggregate trends among children and adolescents younger than 18 years of age. We also quantified how diagnosis and treatment patterns have evolved on the basis of patient and physician characteristics and the therapeutic classes used. RESULTS From 2000 to 2010, the number of physician outpatient visits in which ADHD was diagnosed increased 66% from 6.2 million (95% confidence interval 5.5-6.9M) to 10.4 million visits (95% confidence interval 9.3-11.6 million). Of these visits, psychostimulants have remained the dominant treatment; they were used in 96% of treatment visits in 2000 and 87% of treatment visits in 2010. Atomoxetine use decreased from 15% of treatment visits upon product launch in 2003 to 6% of treatment visits by 2010. The use of potential substitute therapies-clonidine, guanfacine, and bupropion-remained relatively constant (between 5% and 9% of treatment visits) during most of the period examined. During this period, the management of ADHD shifted away from pediatricians and towards psychiatrists (from 24% to 36% of all visits) without large changes in illness severity or the proportion of ADHD treatment visits accounted for by males (73%-77%). CONCLUSIONS In 10 years, the ambulatory diagnosis of ADHD increased by two-thirds and is increasingly managed by psychiatrists. The effects of these changing treatment patterns on childrens health outcomes and their families are unknown.

A Review of Men's Health and Masculinity

Mens health is a new and evolving area of specialty that goes beyond mens cancers and sexual activities. Mens health in the 21st century incorporates a broader conceptualization of health, health behaviors, and lifestyle choices. This new focus results from the fact that men continue to lag behind women in life expectancy and in health care use, a situation that is worse for minority men. Understanding how gender socialization and masculine ideology affects mens health is an important step toward providing effective care for men. In this article, the authors review these areas and then discuss each of the top actual causes of death for men: tobacco use, poor diet, alcohol use, and physical inactivity. They then discuss the important issue of steroid use among men. Throughout the review, the authors highlight racial and ethnic differences in health behaviors. Furthermore, they provide empirically supported clinical implications to assist clinicians who see men with health concerns in their practices. Finally, they offer suggestions for creating ways to include men in the health care system in hopes of improving their use.

The effects of early paternal depression on children's development

Objective: To examine the effects of paternal depression during childrens first year on their wellbeing at 4–5 years of age using a large, representative sample of Australian families.

A Longitudinal Study of Paternal Mental Health During Transition to Fatherhood as Young Adults

BACKGROUND AND OBJECTIVE: Rates of paternal depression range from 5% to 10% with a growing body of literature describing the harm to fathers, children, and families. Changes in depression symptoms over the life course, and the role of social factors, are not well known. This study examines associations with changes in depression symptoms during the transition to fatherhood for young fathers and whether this association differed by key social factors. METHODS: We combined all 4 waves of the National Longitudinal Study of Adolescent Health to support a 23-year longitudinal analysis of 10 623 men and then created a “fatherhood-year” data set, regressing age-adjusted standardized depressive symptoms scores on fatherhood status (nonresidence/residence), fatherhood-years, and covariates to determine associations between Center for Epidemiologic Studies Depression Scale scores and fatherhood life course intervals. RESULTS: Depressive symptom scores reported at the entry into fatherhood are higher for nonresident fathers than nonfathers, which in turn are higher than those of resident fathers. Resident fathers have a significant decrease in scores during late adolescence (β = –0.035, P = .023), but a significant increase in scores during early fatherhood (β = 0.023, P = .041). From entrance into fatherhood to the end of early fatherhood (+5 years), the depressive symptoms score for resident fathers increases on average by 68%. CONCLUSIONS: In our longitudinal, population-based study, resident fathers show increasing depressive symptom scores during childrens key attachment years of 0–5. Identifying at-risk fathers based on social factors and designing effective interventions may ultimately improve health outcomes for the entire family.

Association Between Adolescent Viewership and Alcohol Advertising on Cable Television

OBJECTIVES We examined whether alcohol advertising on cable television is associated with adolescent viewership. METHODS Using Nielsen data for every national cable alcohol advertisement from 2001 to 2006 (608 591 ads), we examined whether ad incidence in a given advertising time slot was associated with adolescent viewership (i.e., the percentage of the audience that was aged 12-20 years) after we controlled for other demographic variables. RESULTS Almost all alcohol ads appeared in time slots with audiences made up of 30% or fewer underage viewers. In these time slots (standardized by duration and number of viewers), each 1-percentage-point increase in adolescent viewership was associated with more beer (7%), spirits (15%), and alcopop (or low-alcohol refresher; 22%) ads, but fewer wine (-8%) ads (P < .001 for all). For spirits and alcopops, associations were stronger among adolescent girls than among adolescent boys (P < .001 for each). CONCLUSIONS Ad placements for beer, spirits, and alcopops increased as adolescent viewership rose from 0% to 30%, especially for female viewers. Alcohol advertising practices should be modified to limit exposure of underage viewers.

Need for and Use of Family Leave Among Parents of Children With Special Health Care Needs

OBJECTIVE. Parents of children with special health care needs are especially vulnerable to work–family conflicts that family leave benefits might help resolve. We examined leave-taking among full-time–employed parents of children with special health care needs. METHODS. We identified all children with special health care needs in 2 large inpatient/outpatient systems in Chicago, Illinois, and Los Angeles, California, and randomly selected 800 per site. From November 2003 to January 2004, we conducted telephone interviews with 1105 (87% of eligible and successfully contacted) parents. Among the samples 574 full-time–employed parents, we examined whether leave benefits predicted missing any work for child illness, missing >4 weeks for child illness, and ability to miss work whenever their child needed them. RESULTS. Forty-eight percent of full-time–employed parents qualified for federal Family and Medical Leave Act benefits; 30% reported employer-provided leave benefits (not including sick leave/vacation). In the previous year, their children averaged 20 missed school/child care days, 12 doctor/emergency department visits, and 1.7 hospitalizations. Although 81% of parents missed work for child illness, 41% reported not always missing work when their child needed them, and 40% of leave-takers reported returning to work too soon. In multivariate regressions, parents who were eligible for Family and Medical Leave Act benefits and aware of their eligibility had 3.0 times greater odds of missing work for child illness than ineligible parents. Parents with >4 weeks of employer-provided leave benefits had 4.7 times greater odds of missing >4 weeks than parents without benefits. Parents with paid leave benefits had 2.8 times greater odds than other parents of missing work whenever their child needed them. CONCLUSIONS. Full-time–employed parents of children with special health care needs experience severe work–family conflicts. Although most have leave benefits, many report unmet need for leave. Access to Family and Medical Leave Act benefits and employer-provided leave may greatly affect leave-taking.

Long-term effects of birth weight and breastfeeding duration on inflammation in early adulthood

Chronic inflammation is a potentially important physiological mechanism linking early life environments and health in adulthood. Elevated concentrations of C-reactive protein (CRP)—a key biomarker of inflammation—predict increased cardiovascular and metabolic disease risk in adulthood, but the developmental factors that shape the regulation of inflammation are not known. We investigated birth weight and breastfeeding duration in infancy as predictors of CRP in young adulthood in a large representative cohort study (n = 6951). Birth weight was significantly associated with CRP in young adulthood, with a negative association for birth weights 2.8 kg and higher. Compared with individuals not breastfed, CRP concentrations were 20.1%, 26.7%, 29.6% and 29.8% lower among individuals breastfed for less than three months, three to six months, 6–12 months and greater than 12 months, respectively. In sibling comparison models, higher birth weight was associated with lower CRP for birth weights above 2.5 kg, and breastfeeding greater than or equal to three months was significantly associated with lower CRP. Efforts to promote breastfeeding and improve birth outcomes may have clinically relevant effects on reducing chronic inflammation and lowering risk for cardiovascular and metabolic diseases in adulthood.

Fathers' roles in the care and development of their children: The role of pediatricians

Fathers’ involvement in and influence on the health and development of their children have increased in a myriad of ways in the past 10 years and have been widely studied. The role of pediatricians in working with fathers has correspondingly increased in importance. This report reviews new studies of the epidemiology of father involvement, including nonresidential as well as residential fathers. The effects of father involvement on child outcomes are discussed within each phase of a child’s development. Particular emphasis is placed on (1) fathers’ involvement across childhood ages and (2) the influence of fathers’ physical and mental health on their children. Implications and advice for all child health providers to encourage and support father involvement are outlined.

Awareness and Use of California's Paid Family Leave Insurance Among Parents of Chronically Ill Children

CONTEXT In 2004, Californias Paid Family Leave Insurance Program (PFLI) became the first state program to provide paid leave to care for an ill family member. OBJECTIVE To assess awareness and use of the program by employed parents of children with special health care needs, a population likely to need leave. DESIGN, SETTING, AND PARTICIPANTS Telephone interviews with successive cohorts of employed parents before (November 21, 2003-January 31, 2004; n = 754) and after (November 18, 2005-January 31, 2006; n = 766) PFLI began, randomly sampled from 2 childrens hospitals, one in California (with PFLI) and the other in Illinois (without PFLI). Response rates were 82% before and 81% after (California), and 80% before and 74% after (Illinois). MAIN OUTCOME MEASURES Taking leave, length of leave, unmet need for leave, and awareness and use of PFLI. RESULTS Similar percentages of parents at the California site reported taking at least 1 day of leave to care for their ill child before (295 [81%]) and after (327 [79%]) PFLI, taking at least 4 weeks before (64 [21%]) and after (74 [19%]) PFLI, and at least once in the past year not missing work despite believing their childs illness necessitated it before (152 [41%]) and after (156 [41%]) PFLI. Relative to Illinois, parents at the California site reported no change from before to after PFLI in taking at least 1 day of leave (difference of differences, -3%; 95% confidence interval [CI], -13% to 7%); taking at least 4 weeks of leave (1%; 95% CI, -9% to 10%); or not missing work, despite believing their childs illness necessitated it (-1%; 95% CI, -13% to 10%). Only 77 parents (18%) had heard of PFLI approximately 18 months after the program began, and only 20 (5%) had used it. Even among parents without other access to paid leave, awareness and use of PFLI were minimal. CONCLUSIONS Parents of children with special health care needs receiving care at a California hospital were generally unaware of PFLI and rarely used it. Among parents of children with special health care needs, taking leave in California did not increase after PFLI implementation compared with Illinois.