Characteristics and publication fate of unregistered and retrospectively registered clinical trials submitted to The BMJ over 4 years.

OBJECTIVES: We sought to evaluate the characteristics and publication fate of improperly registered clinical trials submitted to a medical journal (The BMJ) over a 4-year period to identify common types of registration issues and their relation to publication outcomes. DESIGN: Research articles submitted to The BMJ and identified as unregistered or retrospectively registered by editors were included if they reported outcomes of a clinical trial. Relevant data regarding the trials were then extracted from each paper. Trials were categorised as prospectively registered, registered in an unapproved registry, unregistered or other, and explanations for registration deficiencies were grouped into six categories. We searched PubMed and Google to determine whether, where and when improperly registered studies were subsequently published and whether registration issues were disclosed. RESULTS: 123 research papers reporting apparently unregistered or retrospectively registered clinical trials were identified. 110 studies (89.4%) were retrospectively registered, nine (7.3%) were unregistered, three (2.4%) had been registered in an unapproved registry and one study originally lacking registration details was later discovered to have been prospectively registered. 82 studies (66.6%) were funded entirely or in part by government sources, and only seven studies (5.7%) received funding from industry. Of those papers submitted to The BMJ through the end of 2015, 67 of the 70 papers rejected for registration problems (95.7%) were subsequently published in another journal. The registration problem was disclosed in only 2 (2.9%). CONCLUSIONS: Improper registration remains a problem, particularly for clinical trials that are government or foundation-funded. Nonetheless, improperly registered trials are almost always published, suggesting that medical journal editors may not actively enforce registration requirements.

Posttraumatic Stress Symptoms and their Relationship to Drug and Alcohol use in an International Sample of Latino Immigrants.

We identify the prevalence and correlates of posttraumatic stress (PTSD) symptoms and their relationship to alcohol and substance use disorders (AUD/SUD) among Latino immigrants in two countries. A screening battery assessing PTSD symptoms (PCL-C), alcohol use (AUDIT), drug abuse (DAST), and psychological measures was administered to 562 Latino immigrants recruited in clinics. We used logistical regression analyses to evaluate the relationship between PTSD symptoms and AUD/SUD. Prevalence of elevated PTSD symptoms was high (53.7 % in Boston, 47.9 % in Madrid and, 43.8 % in Barcelona). Screening positive for psychological measures was significantly correlated to screening positive on the PCL-C (p < 0.001). Significant gender differences in risk of AUD/SUD were moderated by PTSD symptoms. Presence of any PTSD symptoms predicted problems with benzodiazepine misuse. Given the high rates of co-morbidity between PTSD symptoms and AUD/SUD, we recommend early interventions for dual pathology for Latino immigrants with trauma history.

The prevalence, burden, and treatment of severe, frequent, and migraine headaches in US minority populations: statistics from National Survey studies.

BACKGROUND: The prevalence and burden of migraine and other severe headaches in the US population as a whole is well documented. Prevalence and treatment patterns in US racial and ethnic minorities, however, have received less attention. We sought to assemble and compare this information as identified in large, nationally representative studies. METHODS: We searched for summary statistics from studies performed in the United States between 1989 and 2014. Included studies had to provide population-based, nationally or broadly representative information on the prevalence, burden, or treatment of severe or frequent headache or migraine in adult US Blacks, Hispanics, Native Americans, or Asians. RESULTS: Nine studies were included in the review. Prevalence data from the National Health Interview Survey (NHIS) provide the most comprehensive information for major racial and ethnic groups. The average prevalence of severe headache or migraine from 2005 to 2012 NHIS was 17.7% for Native Americans, 15.5% for Whites, 14.5% for Hispanics, 14.45% for Blacks, and 9.2% for Asians. Severe headache or migraine prevalence was higher in females of all races and ethnic groups compared with males and across all included studies. Female to male prevalence ratios from the 2005-2012 NHIS were 2.1 for Whites, 2.5 for Hispanics, 2.1 for Blacks, and 2.0 for Asians. Among those with chronic migraine (≥15 days of headache per month), prevalence data from the American Migraine Prevalence and Prevention study showed that the prevalence of chronic migraine was highest in Hispanic women (2.26% compared with 1.2% for White females), whereas White males had the lowest prevalence at 0.46%. Data from the National Hospital Ambulatory Care Survey and National Ambulatory Care Survey show that Hispanics make only 89.5 annual ambulatory care visits per 10,000 population at which they receive a diagnosis of migraine, compared with 176.3 for Whites and 133.2 for Blacks. In contrast, visit rates resulting in a diagnosis of nonspecific headache were more comparable across all groups. Only one study obtained information on selected subgroups within Hispanic and Asian populations. This showed that differences among these subgroups, which suggest composite prevalence estimates for broadly defined racial and ethnic groups such as Asians, may conceal meaningful differences in subgroups, such as Vietnamese or Filipinos. CONCLUSIONS: In the United States, migraine prevalence is highest among Native Americans, then Whites, followed closely by Hispanics and Blacks. Asians have the lowest prevalence of severe, frequent headache or migraine of the major racial or ethnic groups. Differences in diagnosis and treatment of headache and migraine may indicate racial and ethnic disparities in access and quality of care for minority patients.

The prevalence and burden of migraine and severe headache in the United States: updated statistics from government health surveillance studies.

BACKGROUND AND OBJECTIVES: The US National Center for Health Statistics, which is part of the Centers for Disease Control, conducts ongoing public health surveillance activities. The US Armed Forces also maintains a comprehensive database of medical information. We aimed to identify the most current prevalence estimates of migraine and severe headache in the United States adult civilian and active duty service populations from these national government surveys, to assess stability of prevalence estimates over time, and to identify additional information pertinent to the burden and treatment of migraine and other severe headache conditions. METHODS: We searched for the most current publicly available summary statistics from the National Ambulatory Medical Care Survey, the National Hospital Ambulatory Medical Care Survey, and the National Health Interview Survey (NHIS). Summary data from the Defense Medical Surveillance System were also obtained, and PubMed was also searched for publications reporting summary statistics based on these studies. Data were abstracted, double-checked for accuracy, and summarized over time periods and as a function of demographic variables. RESULTS: 14.2% of US adults 18 or older reported having migraine or severe headache in the previous 3 months in the 2012 NHIS. The overall age-adjusted 3-month prevalence of migraine in females was 19.1% and in males 9.0%, but varied substantially depending on age. The prevalence of migraine was highest in females 18-44, where the 3-month prevalence of migraine or severe headache was 23.5%. The 3-month prevalence of migraine or severe headache has remained relatively stable over the period of2005-2012, with an average prevalence of 20.2% in females, 9.4% in males, and 14.9% overall [corrected]. During this time, the average female to male sex ratio for migraine or severe headache was 2.17. The unadjusted 1-year prevalence of migraine in active duty US military service members varied from 1% to 1.9% between 1998 and 2010, ranging from 0.7% to 1.2% in males and 3.5% to 6% in females. The 1-year prevalence of "other headache" in this military population ranged from a low of 1.9% in 2003 to a high of 3% in 2010. Headache or pain in the head was the fourth leading cause of visits to the emergency department (ED) in 2009-2010, accounting for 3.1% of all ED visits. Across all ambulatory care settings, migraine accounted for 0.5% of all visits and other headache presentations for 0.4% of all ambulatory care visits. 52.8% of all visits for migraine occurred in primary care settings, 23.2% in specialty outpatient settings, and 16.7% in EDs. In 2010, opioids were administered at 35% of ED visits for headache, while triptans were administered in only 1.5% of visits. CONCLUSIONS: This report summarizes the most recent government statistics on the prevalence and burden of migraine and severe headache in the US civilian and active duty military populations. The prevalence of migraine headaches is high, affecting roughly 1 out of every 7 Americans annually, and has remained relatively stable over the last 8 years. Migraine and headache are leading causes of outpatient and ED visits and remain an important public health problem, particularly among women during their reproductive years.

The costs and benefits of reducing racial-ethnic disparities in mental health care.

OBJECTIVE: Previous studies have found that timely mental health treatment can result in savings in both mental health and general medical care expenditures. This study examined whether reducing racial-ethnic disparities in mental health care offsets costs of care. METHODS: Data were from a subsample of 6,206 individuals with probable mental illness from the 2004-2010 Medical Expenditure Panel Survey (MEPS). First, disparities in mental health treatment were analyzed. Second, two-year panel data were used to determine the offset of year 1 mental health outpatient and pharmacy treatment on year 2 mental and general medical expenditures. Third, savings were estimated by combining results from steps 1 and 2. RESULTS: Compared with whites, blacks and Latinos with year 1 outpatient mental health care spent less on inpatient and emergency general medical care in year 2. Latinos receiving mental health care in year 1 spent less than others on inpatient general medical care in year 2. Latinos taking psychotropic drugs in year 1 showed reductions in inpatient general medical care. Reducing racial-ethnic disparities in mental health care and in psychotropic drug use led to savings in acute medical care expenditures. CONCLUSIONS: Savings in acute care expenditures resulting from eliminating disparities in racial-ethnic mental health care access were greater than costs in some but not all areas of acute mental health and general medical care. For blacks and Latinos, the potential savings from eliminating disparities in inpatient general medical expenditures are substantial (as much as $1 billion nationwide), suggesting that financial and equity considerations can be aligned when planning disparity reduction programs.

Acculturation differences in communicating information about child mental health between Latino parents and primary care providers.

Significant Latino-white disparities in youth mental health care access and quality exist yet little is known about Latino parents' communication with providers about youth mental health and the role of acculturation in influencing this communication. We estimated regression models to assess the association between time in the US and the number of psychosocial issues discussed with the medical assistant (MA) and doctor, adjusting for child and parent mental health and sociodemographics. Other proxies of acculturation were also investigated including measures of Spanish and English language proficiency and nativity. Parent's length of time in the US was positively associated with their communication of: their child's psychosocial problems with their child's MA, stress in their own life with their child's MA, and their child's school problems with their child's doctor. These differences were especially apparent for parents living in the US for >10 years. Parent-child language discordance, parent and child nativity were also significantly associated with communication of psychosocial problems. Greater provider and MA awareness of variation in resistance to communicating psychosocial issues could improve communication, and improve the prevention, diagnosis and treatment of youth mental illness.

The time is now: tackling racial and ethnic disparities in mental and behavioral health services in Massachusetts.

Massachusetts is in the midst of a demographic shift that will leave the state with unprecedented ethnic, racial and cultural diversity. In light of this change, health care services in the Commonwealth need to respond to and serve an increasingly multicultural population. The time is now for bold initiatives to reduce behavioral health and health service disparities by building collaborations between policymakers, insurers/payers, provider organizations, training institutions, and community groups. In the same way collaboration among diverse stakeholders enabled the Commonwealth to lead the nation in achieving near universal access to health insurance, a new collaboration can pave the way for the elimination of behavioral health and health care disparities. This brief compiles current information on racial and ethnic disparities in mental health and substance use disorders and treatment disparities in Massachusetts. It concludes with state level policy recommendations. The Brief does not recommend policies already in motion, such as moving to universal insurance coverage, enforcement of parity laws, policies to expand coverage of drug treatment services or greater inclusion of consumers in the development and configuration of behavioral health services. Recommendations offered are based on best practices and evidence-based research. Most research, however, studies incremental changes. To transform rather than reform the system, we integrate consideration of experience and research from other policy areas. The ultimate goal is to generate an action plan that motivates policymakers to address persistent racial and ethnic disparities in the availability and quality of behavioral health services in the Commonwealth.