Cost of medication overuse headache in Italian patients at the time-point of withdrawal: a retrospective study based on real data.

The objective was to assess the cost of Medication Overuse Headache (MOH) at the time-point of withdrawal treatment. We implemented a protocol in which both direct and indirect cost were directly gathered from patients and referred to the previous three months. Direct costs were calculated by medications for acute treatment and prophylaxis, diagnostic procedures, visits, complementary treatments, informal care. Indirect costs were referred to missed workdays and workdays with reduced productivity: we asked patients to refer their salaries and to rate the overall level of performance in days worked with reduced productivity, and we calculated indirect costs on this basis. A total of 135 patients were enrolled: direct costs were around 415€/month; indirect costs were 530€/month, and were mostly due to presenteeism (350€, 66.3%) rather than to absenteeism (160€, 33.7%). Our data showed higher cost than those of a previous study: this is likely due to a different approach to cost definition, to the inclusion of direct non-medical cost, and of non-pharmacological treatments.

Coding in Stroke and Other Cerebrovascular Diseases.

Accurate coding is critical for clinical practice and research. Ongoing changes to diagnostic and billing codes require the clinician to stay abreast of coding updates. Payment for health care services, data sets for health services research, and reporting for medical quality improvement all require accurate administrative coding. This article provides an overview of coding principles for patients with strokes and other cerebrovascular diseases and includes an illustrative case as a review of coding principles in a patient with acute stroke.

AMCP Partnership Forum: FDAMA Section 114-Improving the Exchange of Health Care Economic Data.

The Food and Drug Administration Modernization Act (FDAMA) of 1997 included Section 114 as a regulatory safe harbor with the goal of increasing the dissemination of health care economic information (HCEI) to those responsible for formulary decision making. HCEI is typically not included within FDA-approved labeling. Although it has been nearly 20 years since passage and enactment of Section 114, proactive distribution of HCEI has been underutilized by biopharmaceutical companies partly because of (a) vague wording in the statute and (b) the absence of FDA-implementing regulations. Consequently, companies and health care decisions makers have had to speculate about the scope of the provisions. As a result, the biopharmaceutical industry has significant concerns about stepping over the line when using the safe harbor. Also, payers and other "payer-like" decision makers (e.g., self-funded corporate insurers) who are trying to make appropriate coverage and utilization decisions are demanding this information but are not receiving it because of the uncertainties in the statute. Considering this renewed interest by multiple stakeholders regarding the need for revisions and/or guidance pertaining to Section 114, the Academy of Managed Care Pharmacy held a partnership forum on March 1-2, 2016, with a diverse group of health care stakeholders to provide the FDA with considerations for disseminating a guidance document on current thinking for the sharing of HCEI with health care decision makers. Forum participants represented the managed care industry, biopharmaceutical industry, health care providers, pharmacoeconomic experts, policy experts, and patient advocacy groups with specific expertise in the development, use, and dissemination of HCEI. The multistakeholder group represented the key professionals and entities affected by the provisions of Section 114 and present the collective credibility necessary for Congress and the FDA to modernize and operationalize the safe harbor by using the consensus recommendations developed during the forum. Speakers, panelists, and attendees focused on 4 terms in Section 114 that remain open to interpretation by companies and enforcement bodies: (1) the scope of HCEI, (2) the scope of "formulary committee or similar entity," (3) the definition of "competent and reliable scientific evidence (CRSE)," and (4) the parameters of how information "directly relates to an approved indication." Based on the forum results, it was recommended that the safe harbor for companies' proactive dissemination of information under Section 114 should include health care decision makers beyond health plan formulary committees, including organizations, or individuals in their role in an organization, who make health care decisions for patient populations. Recommendations also suggested expansion to organizations that evaluate HCEI or develop value frameworks and compendia and individuals in such organizations. Forum participants also recommended that HCEI be truthful, and not misleading, and be based on the expertise of professionals in the relevant area. HCEI must also be developed and disclosed in a transparent, reproducible, and accurate manner. Forum participants also discussed and agreed on the types of information, format, and processes by which managed care pharmacy and other health care decision makers seek to receive HCEI from biopharmaceutical companies. Finally, participants encouraged the FDA, Congress, and other stakeholders to find ways to ensure that patients or their representative organizations have appropriate access to a full range of information about their medications and that information related to the medication pipeline is communicated to appropriate stakeholders in a timely manner. DISCLOSURES: The AMCP Partnership Forum on FDAMA Section 114-Improving the Exchange of Pharmacoeconomic Data and the development of this proceedings document were supported by AbbVie, Amgen, Boehringer Ingelheim Pharmaceuticals, Merck & Co., National Pharmaceutical Council, Pharmaceutical Research and Manufacturers of America, Precision for Value, Pfizer, Takeda Pharmaceuticals, U.S.A., and Xcenda. All sponsors participated in the forum and participated in revising and approving the manuscript.

WHO essential medicines policies and use in developing and transitional countries: an analysis of reported policy implementation and medicines use surveys.

BACKGROUND: Suboptimal medicine use is a global public health problem. For 35 years the World Health Organization (WHO) has promoted essential medicines policies to improve quality use of medicines (QUM), but evidence of their effectiveness is lacking, and uptake by countries remains low. Our objective was to determine whether WHO essential medicines policies are associated with better QUM. METHODS AND FINDINGS: We compared results from independently conducted medicines use surveys in countries that did versus did not report implementation of WHO essential medicines policies. We extracted survey data on ten validated QUM indicators and 36 self-reported policy implementation variables from WHO databases for 2002-2008. We calculated the average difference (as percent) for the QUM indicators between countries reporting versus not reporting implementation of specific policies. Policies associated with positive effects were included in a regression of a composite QUM score on total numbers of implemented policies. Data were available for 56 countries. Twenty-seven policies were associated with better use of at least two percentage points. Eighteen policies were associated with significantly better use (unadjusted p<0.05), of which four were associated with positive differences of 10% or more: undergraduate training of doctors in standard treatment guidelines, undergraduate training of nurses in standard treatment guidelines, the ministry of health having a unit promoting rational use of medicines, and provision of essential medicines free at point of care to all patients. In regression analyses national wealth was positively associated with the composite QUM score and the number of policies reported as being implemented in that country. There was a positive correlation between the number of policies (out of the 27 policies with an effect size of 2% or more) that countries reported implementing and the composite QUM score (r=0.39, 95% CI 0.14 to 0.59, p=0.003). This correlation weakened but remained significant after inclusion of national wealth in multiple linear regression analyses. Multiple policies were more strongly associated with the QUM score in the 28 countries with gross national income per capita below the median value (US$2,333) (r=0.43, 95% CI 0.06 to 0.69, p=0.023) than in the 28 countries with values above the median (r=0.22, 95% CI -0.15 to 0.56, p=0.261). The main limitations of the study are the reliance on self-report of policy implementation and measures of medicine use from small surveys. While the data can be used to explore the association of essential medicines policies with medicine use, they cannot be used to compare or benchmark individual country performance. CONCLUSIONS: WHO essential medicines policies are associated with improved QUM, particularly in low-income countries. Please see later in the article for the Editors' Summary.

Data processing costs for three posture assessment methods.

BACKGROUND: Data processing contributes a non-trivial proportion to total research costs, but documentation of these costs is rare. This paper employed a priori cost tracking for three posture assessment methods (self-report, observation of video, and inclinometry), developed a model describing the fixed and variable cost components, and simulated additional study scenarios to demonstrate the utility of the model. METHODS: Trunk and shoulder postures of aircraft baggage handlers were assessed for 80 working days using all three methods. A model was developed to estimate data processing phase costs, including fixed and variable components related to study planning and administration, custom software development, training of analysts, and processing time. RESULTS: Observation of video was the most costly data processing method with total cost of € 30,630, and was 1.2-fold more costly than inclinometry (€ 26,255), and 2.5-fold more costly than self-reported data (€ 12,491). Simulated scenarios showed altering design strategy could substantially impact processing costs. This was shown for both fixed parameters, such as software development and training costs, and variable parameters, such as the number of work-shift files processed, as well as the sampling frequency for video observation. When data collection and data processing costs were combined, the cost difference between video and inclinometer methods was reduced to 7%; simulated data showed this difference could be diminished and, even, reversed at larger study sample sizes. Self-report remained substantially less costly under all design strategies, but produced alternate exposure metrics. CONCLUSIONS: These findings build on the previously published data collection phase cost model by reporting costs for post-collection data processing of the same data set. Together, these models permit empirically based study planning and identification of cost-efficient study designs.

Intergenerational transmission of reproductive behavior during the demographic transition.

New evidence from the Utah Population Database (UPDP) reveals that at the onset of the fertility transition, reproductive behavior was transmitted across generations - between women and their mothers, as well as between women and their husbands' family of origin. Age at marriage, age at last birth, and the number of children ever born are positively correlated in the data, most strongly among first-born daughters and among cohorts born later in the fertility transition. Intergenerational ties, including the presence of mothers and mothers-in-law, influenced the hazard of progressing to a next birth. The findings suggest that the practice of parity-dependent marital fertility control and inter-birth spacing behavior derived, in part, from the previous generation and that the potential for mothers and mothers-in-law to help in the rearing of children encouraged higher marital fertility.

Economic analysis of secondary trial data.

Clinical trials may furnish data to conduct economic analyses. An economic analysis requires us to identify all opportunity costs associated with the intervention over the time horizon chosen for the analysis and enumerate the improvements in benefits from the intervention of interest. We review the basic steps used when performing economic studies based on secondary analysis of data from clinical trials using examples from myocardial infarction studies. Different types of economic analyses and the potential contributions of Markov modeling are described. Issues of measuring quality of life, patient utilities, cost of care, and potential sources of cost data are reviewed. The interpretation of incremental cost-effectiveness ratios is discussed and economic benchmarks for defining good and poor value interventions are provided.

Composition, concentration and deprivation: exploring their association with social cohesion among different ethnic groups in the UK.

Although studies in the US have shown an association between the ethnic residential composition of an area and reports of decreased social cohesion among its residents, this association is not clear in the UK, and particularly for ethnic minority groups. The current study analyses a merged dataset from the 2005 and 2007 Citizenship Survey to assess the evidence for an association between social cohesion and ethnic residential concentration, composition and area deprivation across different ethnic groups in the UK. Results of the multilevel regression models show that, after adjusting for area deprivation, increased levels of social cohesion are found in areas of greater ethnic residential heterogeneity. Although different patterns emerge across ethnic groups and the measure of social cohesion used, findings consistently show that it is area deprivation, and not ethnic residential heterogeneity, which erodes social cohesion in the UK.

Methods, approaches and data sources for estimating stocks of irregular migrants.

This paper presents a comprehensive review of available methods for sizing irregular migrant populations as a particular group in the study of hidden populations. Based on the existing body of literature on the subject, a generic classification scheme is developed that divides existing estimation procedures into subcategories like "approaches", "methods" and "estimation techniques". For each of these categories, basic principles, methodical strengths and weaknesses, as well as practical problems, are identified and discussed with the use of existing examples. Special emphasis is placed on data requirements, data shortcomings and possible estimation biases. In addition, based on the empirical classification and quality assessment of country-specific estimates developed in the CLANDESTINO research project, the potential and requirements for replicating best practice models in other countries are explored. Finally, a number of conclusions on the appropriate design of estimation projects are offered.

The size of the irregular migrant population in the European Union ­ counting the uncountable?

It is difficult to estimate the size of the irregular migrant population in a specific city or country, and even more difficult to arrive at estimates at the European level. A review of past attempts at European-level estimates reveals that they rely on rough and outdated rules-of-thumb. In this paper, we present our own European level estimates for 2002, 2005, and 2008. We aggregate country-specific information, aiming at approximate comparability by consistent use of minimum and maximum estimates and by adjusting for obvious differences in definition and timescale. While the aggregated estimates are not considered highly reliable, they do -- for the first time -- provide transparency. The provision of more systematic medium quality estimates is shown to be the most promising way for improvement. The presented estimate indicates a minimum of 1.9 million and a maximum of 3.8 million irregular foreign residents in the 27 member states of the European Union (2008). Unlike rules-of-thumb, the aggregated EU estimates indicate a decline in the number of irregular foreign residents between 2002 and 2008. This decline has been influenced by the EU enlargement and legalisation programmes.

Child-care availability and fertility in Norway.

The child-care and fertility hypothesis has been in the literature for a long time and is straightforward: As child care becomes more available, affordable, and acceptable, the antinatalist effects of increased female educational attainment and work opportunities decrease. As an increasing number of countries express concern about low fertility, the child-care and fertility hypothesis takes on increased importance. Yet data and statistical limitations have heretofore limited empirical tests of the hypothesis. Using rich longitudinal data and appropriate statistical methodology, We show that increased availability of child care increases completed fertility. Moreover, this positive effect of child-care availability is found at every parity transition. We discuss the generalizability of these results to other settings and their broader importance for understanding variation and trends in low fertility.

The effects of racial/ethnic segregation on Latino and Black homicide.

Racial/ethnic residential segregation has been shown to contribute to violence and have harmful consequences for minority groups. However, research examining the segregation­crime relationship has focused almost exclusively on blacks and whites while largely ignoring Latinos and other race/ethnic groups and has rarely considered potential mediators (e.g., concentrated disadvantage) in segregation­violence relationships. This study uses year 2000 arrest data for California and New York census places to extend segregation­crime research by comparing the effects of racial/ethnic residential segregation from whites on black and Latino homicide. Results indicate that (1) racial/ethnic segregation contributes to both Latino and black homicide, and (2) the effects for both groups are mediated by concentrated disadvantage. Implications for segregation­violence relationships, the racial-invariance position, and the Latino paradox are discussed.

China's below-replacement fertility: government policy or socioeconomic development?

The article challenges the notion that below-replacement fertility and its local variation in China are primarily attributable to the government's birth planning policy. Data from the 2000 census and provincial statistical yearbooks are used to compare fertility in Jiangsu and Zhejiang, two of the most developed provinces in China, to examine the relationship between socioeconomic development and low fertility. The article demonstrates that although low fertility in China was achieved under the government's restrictive one-child policy, structural changes brought about by socioeconomic development and ideational shifts accompanying the new wave of globalization played a key role in China's fertility reduction.

Population decline in Polish and Czech cities during post-socialism? Looking behind the official statistics.

The evolving debate on "urban shrinkage" mirrors an increasing interest in demographic phenomena on the part of urban scholars. This paper discusses ambiguous evidence about recent population decline in the large cities of Poland and the Czech Republic, with a particular focus on Lódz and Brno in general and their inner cities more specifically. By applying a mixed-method approach, the paper identifies indications of inner-city repopulation and socio-demographic diversification which are not yet apparent in register or census data. It is argued that there are indications of a silent transformation of traditional residential patterns and neighbourhoods in east central Europe. In the inner cities, this is reflected, amongst other things, by the presence of new households that may be called "transitory urbanites".

Who lives and dies on death row? Race, ethnicity, and post-sentence outcomes in Texas.

A substantial body of research has explored the extent to which the race of offenders and victims influences who receives a death sentence for capital crimes. Little is known about how race and ethnicity might pattern death-row outcomes. Drawing upon evidence from male offenders sentenced to death in Texas during the years 1974 through 2009, we extend recent research by examining whether the race and ethnicity of offenders and victims and a number of offender, victim, and crime attributes influence the likelihood of executions and sentence relief (whereby prisoners leave death row). Cox regression analyses are used in conjunction with a multiple-imputation method for handling a modest amount of missing data. The results show that cases involving minorities­with black or Latino offenders or victims­have lower hazards of execution than cases in which both offenders and victims are white. Victim and offender race and ethnicity have little to no independent effect upon the hazard of sentence relief.

All connected? Geographies of race, death, wealth, votes and births.

In January 2010 we learnt that within London the best-off 10th of the population each had recourse to 273 times the wealth of the worse-off 10th of that population (Hills et al. 2010, An anatomy of economic inequality in the UK Report of the National Equality Panel, Government Equalities Office, London). It is hard to find any city in an affluent country that is more unequal. This wealth gap did not include the assets of the UK super-rich, who mostly live in or near London. In April 2010 the Sunday Times newspaper reported the wealth of the richest 1000 people in the UK had risen by an average of £77 million each in just one year, to now stand at £335.5 billion. Today in the UK we are again as unequal as we were around 1918. For 60 years we became more equal, but for the last 30 years, more unequal. Looking at inequality trends it is very hard, initially, to notice when the party of government changed. However, closer inspection of the time series suggests there were key times when the trends changed direction, when the future was much less like the past and when how people voted and acted appeared to matter more than at other times. With all three main parties offering what may appear to be very similar solutions to the issue of reducing inequality it seems unlikely that voting in 2010 will make much of a difference. However, today inequalities are now at unsustainable extremes. Action has been taken such that some inequalities, especially in education, have begun to shrink. The last two times that the direction of trends in inequalities changed, in the 1920s and 1970s, there were several general elections held within a relatively short time period. Inequality is expensive. The UK is not as well-off as it once was. It could be time for a change again. Which way will we go?

The politics of hope and despair: the effect of presidential election outcomes on suicide rates.

OBJECTIVES: This article examines the effect of election outcomes on suicide rates by combining the theory of social integration developed by Durkheim with the models of rational choice used in economics. METHODS: Theory predicts that states with a greater percentage of residents who supported the losing candidate would tend to exhibit a relative increase in suicide rates. However, being around others who also supported the losing candidate may indicate a greater degree of social integration at the local level, thereby lowering relative suicide rates. We therefore use fixed-effects regression of state suicide rates from 1981 to 2005 on state election outcomes during presidential elections to determine which effect is stronger. RESULTS: We find that the local effect of social integration is dominant. The suicide rate when a state supports the losing candidate will tend to be lower than if the state had supported the winning candidate-4.6 percent lower for males and 5.3 percent lower for females. CONCLUSION: Social integration works at many levels; it not only affects suicide risk directly, but can mediate other shocks that influence suicide risk.