Association of State Insulin Out-of-Pocket Caps With Insulin Cost-Sharing and Use Among Commercially Insured Patients With Diabetes : A Pre-Post Study With a Control Group.

BACKGROUND: Twenty-five states have implemented insulin out-of-pocket (OOP) cost caps, but their effectiveness is uncertain. OBJECTIVE: To examine the effect of state insulin OOP caps on insulin use and OOP costs among commercially insured persons with diabetes. DESIGN: Pre-post study with control group. SETTING: Eight states implementing insulin OOP caps of $25 to $30, $50, or $100 in January 2021, and 17 control states. PARTICIPANTS: Commercially insured persons with diabetes and insulin users younger than 65 years. Subgroups of particular interest included members from states with insulin OOP caps of $25 to $30, enrollees with health savings accounts (HSAs) that require high insulin OOP payments, and lower-income members. MEASUREMENTS: Mean monthly 30-day insulin fills and OOP costs. RESULTS: State insulin caps were not associated with changes in insulin use in the overall population (relative change in fills per month, 1.8% [95% CI, -3.2% to 6.9%]). Insulin users in intervention states saw a 17.4% (CI, -23.9% to -10.9%) relative reduction in insulin OOP costs, largely driven by reductions among HSA enrollees; there was no difference in OOP costs among nonaccount plan members. More generous ($25 to $30) state insulin OOP caps were associated with insulin OOP cost reductions of 40.0% (CI, -62.5% to -17.6%), again primarily driven by a larger reduction in the subgroup with HSA plans. LIMITATIONS: Single national insurer; 9-month follow-up. CONCLUSION: Insulin OOP caps were associated with reduced insulin OOP costs but no overall increases in insulin use. A proposed national insulin cap of $35 for commercially insured persons might lead to meaningful insulin OOP savings but have a limited effect on insulin use. PRIMARY FUNDING SOURCE: Centers for Disease Control and Prevention and National Institute of Diabetes and Digestive and Kidney Diseases.

How do carbon emissions trading impact the financialization of non-financial companies? Evidence from a quasi-natural experiment in China.

This study examines whether and how carbon trading policy impacts the financialization of non-financial firms, using China emission trading scheme as a quasi-natural experiment. We find that the carbon trading policy exerts a substantial and enduring inhibitory effect on corporate financialization. Our findings are robust to possible result bias and more precise control group. Additionally, we explore potential channels through which carbon trading policy can affect financialization, and find that it curbs financialization by reducing financing constraints. Finally, we demonstrate that the relationship between carbon trading policy and financialization of non-financial companies is moderated by company's ownership, region, and industry competition.

Effect of the clinical decision assessment system on clinical outcomes of delirium in hospitalized older adults: study protocol for a pair-matched, parallel, cluster randomized controlled superiority trial.

BACKGROUND: Prompt recognition of delirium is the first key step in its proper management. A previous study has demonstrated that nurses' delirium screening using the usual paper version assessment tool has no effect on clinical outcomes. Clinical decision assessment systems have been demonstrated to improve patients' adherence and clinical outcomes. Therefore, We developed a clinical decision assessment system (3D-DST) based on the usual paper version (3-min diagnostic interview for CAM-defined delirium), which was developed for assessing delirium in older adults with high usability and accuracy. However, no high quality evidence exists on the effectiveness of a 3D-DST in improving outcomes of older adults compared to the usual paper version. METHODS: A pair-matched, open-label, parallel, cluster randomized controlled superiority trial following the SPIRIT checklist. Older patients aged 65 years or older admitted to four medical wards of a geriatric hospital will be invited to participate in the study. Prior to the study, delirium prevention and treatment interventions will be delivered to nurses in both the intervention and control groups. The nurses in the intervention group will perform routine delirium assessments on the included older patients with 3D-DST, while the nurses in the control group will perform daily delirium assessments with the usual paper version. Enrolled patients will be assessed twice daily for delirium by a nurse researcher using 3D-DST. The primary outcome is delirium duration. The secondary outcomes are delirium severity, incidence of delirium, length of stay, in-hospital mortality, adherence to delirium assessment, prevention, and treatment of medical staff. DISCUSSION: This study will incorporate the 3D-DST into clinical practice for delirium assessment. If our study will demonstrate that 3D-DST will improve adherence with delirium assessment and clinical outcomes in older patients, it will provide important evidence for the management of delirium in the future. TRIAL REGISTRATION: Chinese Clinical Trial Registry, Identifier: ChiCTR1900028402. https://www.chictr.org.cn/showproj.aspx?proj=47127 . PROTOCOL VERSION: 1, 29/7/22.

The paradox of closing mutual funds to new investors.

I provide an explanation for the well-established paradox that mutual funds that close to new investors fail to maintain their pre-closure positive abnormal performance after closing. Using a large sample of active US equity mutual funds, I find that the within-style performance ranks of closed funds revert to the mean as strongly as those of a control group of open funds. Furthermore, I show that funds that are closed do not drastically alter their investment allocations and hold portfolios that are indistinguishable from their portfolios prior to closing in terms of risk-adjusted performance. Therefore, mean reverting stock returns explain the deterioration in fund performance after closing to new investors. I also document that funds are not capable of better preserving their assets when anticipating a decline in performance by closing to new investors and thus adding exclusivity. Furthermore, the control group of open funds does not suffer from excessive flows. Closing to new investors is at best unnecessary from the stand-alone perspective of the fund.

Expanded nursing competencies to improve person-centred care for nursing home residents with complex health needs (Expand-Care): study protocol for an exploratory cluster-randomised trial.

INTRODUCTION: Older age is associated with multimorbidity, chronic diseases and acute deteriorations and leads to complex care needs. Nursing home residents are more often unnecessarily transferred to emergency departments or hospitals than community dwellers-largely due to a lack of qualified staff and diffusion of responsibility in the institutions. In Germany, only few academically trained nurses work in nursing homes, and their potential roles are unclear. Therefore, we aim to explore feasibility and potential effects of a newly defined role profile for nurses with bachelors' degree or equivalent qualification in nursing homes. METHODS AND ANALYSIS: A pilot study (Expand-Care) with a cluster-randomised controlled design will be conducted in 11 nursing homes (cluster) in Germany, with an allocation ratio of 5:6 to the intervention or control group, aiming to include 15 residents per cluster (165 participants in total). Nurses in the intervention group will receive training to perform role-related tasks such as case reviews and complex geriatric assessments. We will collect data at three time points (t0 baseline, t1 3 months and t2 6 months after randomisation). We will measure on residents' level: hospital admissions, further health services use and quality of life; clinical outcomes (eg, symptom burden), physical functioning and delivery of care; mortality, adverse clinical incidents and changes in care level. On nurses' level, we will measure perception of the new role profile, competencies and implementation of role-related tasks as part of the process evaluation (mixed methods). An economic evaluation will explore resource use on residents' (healthcare utilisation) and on nurses' level (costs and time expenditure). ETHICS AND DISSEMINATION: The ethics committees of the University of Lübeck (Nr. 22-162) and the University Clinic Hamburg-Eppendorf (Nr. 2022-200452-BO-bet) approved the Expand-Care study. Informed consent is a prerequisite for participation. Study results will be published in open-access, peer-reviewed journals and reported at conferences and in local healthcare providers' networks. TRIAL REGISTRATION NUMBER: DRKS00028708.

Anchoring effects in the assessment of papers: An empirical survey of citing authors.

In our study, we have empirically studied the assessment of cited papers within the framework of the anchoring-and-adjustment heuristic. We are interested in the question whether the assessment of a paper can be influenced by numerical information that act as an anchor (e.g. citation impact). We have undertaken a survey of corresponding authors with an available email address in the Web of Science database. The authors were asked to assess the quality of papers that they cited in previous papers. Some authors were assigned to three treatment groups that receive further information alongside the cited paper: citation impact information, information on the publishing journal (journal impact factor) or a numerical access code to enter the survey. The control group did not receive any further numerical information. We are interested in whether possible adjustments in the assessments can not only be produced by quality-related information (citation impact or journal impact), but also by numbers that are not related to quality, i.e. the access code. Our results show that the quality assessments of papers seem to depend on the citation impact information of single papers. The other information (anchors) such as an arbitrary number (an access code) and journal impact information did not play a (important) role in the assessments of papers. The results point to a possible anchoring bias caused by insufficient adjustment: it seems that the respondents assessed cited papers in another way when they observed paper impact values in the survey. We conclude that initiatives aiming at reducing the use of journal impact information in research evaluation either were already successful or overestimated the influence of this information.

A win ratio approach for comparing crossing survival curves in clinical trials.

Many clinical trials include time-to-event or survival data as an outcome. To compare two survival distributions, the log-rank test is often used to produce a P-value for a statistical test of the null hypothesis that the two survival curves are identical. However, such a P-value does not provide the magnitude of the difference between the curves regarding the treatment effect. As a result, the P-value is often accompanied by an estimate of the hazard ratio from the proportional hazards model or Cox model as a measurement of treatment difference. However, one of the most important assumptions for Cox model is that the hazard functions for the two treatment groups are proportional. When the hazard curves cross, the Cox model could lead to misleading results and the log-rank test could also perform poorly. To address the problem of crossing curves in survival analysis, we propose the use of the win ratio method put forward by Pocock et al. as an estimand for analysing such data. The subjects in the test and control treatment groups are formed into all possible pairs. For each pair, the test treatment subject is labelled a winner or a loser if it is known who had the event of interest such as death. The win ratio is the total number of winners divided by the total number of losers and its standard error can be estimated using Bebu and Lachin method. Using real trial datasets and Monte Carlo simulations, this study investigates the power and type I error and compares the win ratio method with the log-rank test and Cox model under various scenarios of crossing survival curves with different censoring rates and distribution parameters. The results show that the win ratio method has similar power as the log-rank test and Cox model to detect the treatment difference when the assumption of proportional hazards holds true, and that the win ratio method outperforms log-rank test and Cox model in terms of power to detect the treatment difference when the survival curves cross.

The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain.

Assessment of reversibility from nonclinical toxicity findings in animals with potential adverse clinical impact is required during pharmaceutical development, but there is flexibility around how and when this is performed and if recovery animals are necessary. For monoclonal antibodies (mAbs) and in accordance with ICH S6(R1) if inclusion of recovery animals is warranted, this need only occur in one study. Data on study designs for first-in-human (FIH)-enabling and later-development toxicity studies were shared from a recent collaboration between the NC3Rs, EPAA, Netherlands Medicines Evaluation Board (MEB) and 14 pharmaceutical companies. This enabled a review of practices on recovery animal use during mAb development and identification of opportunities to reduce research animal use. Recovery animals were included in 68% of FIH-enabling and 69% of later-development studies, often in multiple studies in the same program. Recovery groups were commonly in control plus one test article-dosed group or in all dose groups (45% of studies, each design). Based on the shared data review and conclusions, limiting inclusion of recovery to a single nonclinical toxicology study and species, study design optimisation and use of existing knowledge instead of additional recovery groups provide opportunities to further reduce animal use within mAb development programs.

Retrospective analysis of the potential use of virtual control groups in preclinical toxicity assessment using the eTOX database.

Virtual Control Groups (VCGs) based on Historical Control Data (HCD) in preclinical toxicity testing have the potential to reduce animal usage. As a case study we retrospectively analyzed the impact of replacing Concurrent Control Groups (CCGs) with VCGs on the treatment-relatedness of 28 selected histopathological findings reported in either rat or dog in the eTOX database. We developed a novel methodology whereby statistical predictions of treatment-relatedness using either CCGs or VCGs of varying covariate similarity to CCGs were compared to designations from original toxicologist reports; and changes in agreement were used to quantify changes in study outcomes. Generally, the best agreement was achieved when CCGs were replaced with VCGs with the highest level of similarity; the same species, strain, sex, administration route, and vehicle. For example, balanced accuracies for rat findings were 0.704 (predictions based on CCGs) vs. 0.702 (predictions based on VCGs). Moreover, we identified covariates which resulted in poorer identification of treatment-relatedness. This was related to an increasing incidence rate divergence in HCD relative to CCGs. Future databases which collect data at the individual animal level including study details such as animal age and testing facility are required to build adequate VCGs to accurately identify treatment-related effects.

20 anos da comissão consultiva em avaliação psicológica: desafios da ADI 3481 / 20 years of the advisory committee on psychological assessment: challenges of ADI 3481 / 20 años de la comisión consultiva en evaluación psicológica: desafíos de la ADI 3481

A Comissão Consultiva em Avaliação Psicológica (CCAP) do Conselho Federal de Psicologia (CFP), em seu 20º aniversário, vem discutir os possíveis efeitos, ainda efetivamente desconhecidos, da Ação Direta de Inconstitucionalidade (ADI) 3481, instruída no Supremo Tribunal Federal (STF), a qual desestruturou o modo como os testes psicológicos eram comercializados no Brasil. A livre comercialização de testes psicológicos coloca em risco a segurança de avaliações psicológicas e cabe à categoria profissional pensar estratégias de enfrentamento desses riscos. Neste artigo, são discutidos possíveis efeitos da ADI 3481 para a categoria profissional da psicologia, bem como para a sociedade em geral, e são também elencadas possíveis estratégias de enfrentamento desses riscos, sem desconsiderar aspectos éticos relacionados a eles. Dessa forma, busca-se neste manuscrito, além da problematização dos efeitos derivados da ADI 3481, pensar soluções ou alternativas que venham a redirecionar a trajetória da área da avaliação psicológica no Brasil. Com isso, abre-se um espaço de discussão e encaminhamentos que a categoria profissional precisará tomar nos próximos anos.(AU)

The Advisory Commission for Psychological Assessment of the Federal Council of Psychology discusses, on its 20th anniversary, the possible and still effectively unknown effects of the Direct Action of Unconstitutionality (DAU) 3481, following the Supreme Federal Court, which interrupted how psychological tests were marketed in Brazil. The free trade of psychological tests puts the safety of psychological assessments at risk, and this professional category must think of strategies to face these risks. This study discusses the possible effects of DAU 3481 for professional psychology and for society in general, listing possible strategies for coping with these risks without disregarding its ethical aspects. Thus, this study seeks to problematize the effects derived from DAU 3481 and think of solutions or alternatives that may redirect the trajectory of the field of psychological assessment in Brazil, thus opening a space for discussion and referrals professional psychology will require in the coming years.(AU)

La Comisión Consultiva en Evaluación Psicológica (CCEP) del Consejo Federal de Psicología (CFP), en su 20.º aniversario, propone discutir los posibles efectos aún efectivamente desconocidos de la Acción Directa de Inconstitucionalidad (ADI) 3481, determinada por el Supremo Tribunal Federal (STF), por la cual trastornó la forma de comercializar las pruebas psicológicas en Brasil. La comercialización sin restricciones de las pruebas psicológicas pone en riesgo la seguridad de las evaluaciones psicológicas, y le corresponde a la categoría profesional pensar estrategias para enfrentar estos riesgos. En este artículo se discuten los posibles efectos de la ADI 3481 para la categoría profesional de la Psicología, así como para la sociedad en general, pero también se enumeran posibles estrategias para el enfrentamiento de estos riesgos, sin descuidar los aspectos éticos relacionados con ellos. Así, este manuscrito busca, además de problematizar los efectos derivados de la ADI 3481, pensar en soluciones o alternativas que puedan reconducir la trayectoria del campo de la evaluación psicológica en Brasil. Esto abre un espacio de discusión y derivaciones que la categoría profesional deberá tomar en los próximos años.(AU)

Comparative assessment of enamel remineralisation on the surface microhardness of demineralized enamel - an in vitro study.

Objective: The main objective of the study was to compare two different remineralising materials containing casein phosphopeptide-amorphous calcium phosphate, bioactive glass on enamel surface microhardness. Materials and Methods: Thirty premolars were used for specimen preparation. Group 1 (the control group) consisted of intact enamel samples, group 2: CPP-ACPF (Tooth Mousse Plus), group 3: bioenamel remineralising gel (Prevest DenPro). All specimens were subjected to demineralisation except the control group, followed by which remineralising agents were applied. A universal hardness tester was used to assess the surface microhardness of all samples. Results were analysed using one-way ANOVA test and comparison was analysed using Scheffe's post hoc least significant difference (LSD) test. Results: Both remineralising agents used in groups 2 and 3 have shown significant outcome in terms of improving the surface microhardness in comparison with the control group. Group 2 increased the enamel hardness by 8.34 where P = 0.023 whereas group 3 increased the hardness by 5.87, where P = 0.01. Conclusion: Group 2 has a superior hardness value than group 3; however, no statistically significant results were obtained between both the groups.

Antiseizure medication and perceived "fair" cost allocation: A factorial survey among neurologists, persons with epilepsy, their relatives, and a control group.

OBJECTIVE: Because resources are limited in modern health care systems, the decision on the allocation of expensive drugs can be supported by a public consent. This study examines how various factors influence subjectively perceived "fair" pricing of antiseizure medication (ASM) among four groups including physicians, persons with epilepsy (PWEs), their relatives, and a control group. METHODS: We conducted a factorial survey. Vignettes featured a fictional PWE receiving a fictional ASM. The characteristics of the fictional PWE, ASM, and epilepsy varied. Participants were asked to assess the subjectively appropriate annual cost of ASM treatment per year for each scenario. RESULTS: Fifty-seven PWEs (mean age (SD) 37.7 ± 12.3, 45.6% female), 44 relatives (age 48.4 ± 15.7, 51.1% female), 46 neurologists (age 37.1 ± 9.6, 65.2% female), and 47 persons in the control group (age 31.2 ± 11.2, 68.1% female) completed the questionnaire. The amount of money that respondents were willing to spend for ASM treatment was higher than currently needed in Germany and increased with disease severity among all groups. All groups except for PWEs accepted higher costs of a drug with better seizure control. Physicians and the control group, but not PWEs and their relatives, tended to do so also for minor or no side effects. Physicians reduced the costs for unemployed patients and the control group spent less money for older patients. SIGNIFICANCE: ASM effectiveness appears to justify higher costs. However, the control group attributed less money to older PWEs and physicians allocated fewer drug costs to unemployed PWEs.

Assessment of Mental Workload by Visual Motor Activity among Control Group and Patient Suffering from Depressive Disorder.

Major depressive disorder (MDD) is a mood state that is not usually associated with vision problems. Recent research has found that the inhibitory neurotransmitter GABA levels in the occipital brain have dropped. Aim. The aim of the research is to evaluate mental workload by single channel electroencephalogram (EEG) approach through visual-motor activity and comparison of parameter among depressive disorder patient and in control group. Method. Two tests of a visual-motor task similar to reflect drawings were performed in this study to compare the visual information processing of patients with depression to that of a placebo group. The current study looks into the accuracy of monitoring cognitive burden with single-channel portable EEG equipment. Results. The alteration of frontal brain movement in reaction to fluctuations in cognitive burden stages generated through various vasomotor function was examined. By applying a computerised oculomotor activity analogous to reflector image diagram, we found that the complexity of the path to be drawn was more important than the real time required accomplishing the job in determining perceived difficulty in depressive disorder patients. The overall perceived difficulty of the exercise is positively linked with EEG activity measured from the motor cortex region at the start of every experiment test. The average rating for task completion for depression patients and in control group observed and no statistical significance association reported between rating scale and time spent on each trial (p=1.43) for control group while the normalised perceived difficulty rating had 0.512, 0.623, and 0.821 correlations with the length of the pathway, the integer of inclination in the pathway, and the time spent to complete every experiment test, respectively (p < 0.0001) among depression patients. The findings imply that alterations in comparative cognitive burden levels during an oculomotor activity considerably modify frontal EEG spectrum. Conclusion. Patients with depression perceived the optical illusion in the arrays as weaker, resulting in a little bigger disparity than individuals who were not diagnosed with depression. This discovery provided light on the prospect of adopting a user-friendly mobile EEG technology to assess mental workload in everyday life.

The Impact of the Affordable Care Act on Trauma Outcomes in At-Risk Groups: An Interrupted Time Series Analysis with Control Group.

OBJECTIVE: Analyze the impact of the Affordable Care Act (ACA) on trauma outcomes at a population level and within at-risk subgroups. BACKGROUND: Trauma disproportionately affects the uninsured. Compared to the insured, uninsured patients have worse functional outcomes and increased mortality. The goal of the ACA was to increase access to insurance. METHODS: An interrupted time series was conducted using data from the National Inpatient Sample database between 2011 and 2016. Data from Alberta, Canada was used as a control group. Mortality, length of stay, and probability of discharge home with or without home health care was examined using monthly time intervals, with January 2014 as the intervention time. Single and multiple group interrupted time series were conducted. Subgroup analyses were conducted using income quartiles and race. RESULTS: After the intervention, there was a monthly reduction in mortality of 0.0148% ( P < 0.01) in the American cohort: there was no change in the Canadian cohort. The White subgroup experienced a mortality reduction: the non-White subgroup did not. There was no significant change in length of stay or discharge home rate at a population level. There was a monthly increase in the probability of discharge with home health (0.0247%: P < 0.01); this was present in the lower-income quartiles and both race groups. The White subgroup had a higher rate of utilization of home health pre-ACA, and this discrepancy persisted post-ACA. CONCLUSIONS: The ACA is associated with improved mortality and increased use of home health services. Discrepancies amongst racial groups and income quartiles are present.

Hegemony of economic values in conducting clinical trials with a placebo-control group to investigate the treatment of periodontitis in lower-middle-income countries.

This article analyzes the bioethical implications of using a control/placebo group when conducting clinical trials (CTs) investigating the treatment of periodontitis. For this, the deductive method was used, proposing the interrelation of values, and a scoping systematic review was carried out. A total of 53% of the CTs reviewed were performed in low- and middle-income (LMI) countries, and 92% used a control/placebo group as a comparison group. Although there is a gold standard for the adjunctive treatment of periodontitis, the research ethics committees of most of the analyzed studies approved the use of control/placebo groups for the performance of CTs that did not explore new therapeutic alternatives. In some cases, the CT protocols were not approved by ethics committees, nor was informed consent used. In the LMI countries, a shorter period of recruitment was observed for patients who attended universities and public hospitals. Likewise, most of the CTs reviewed had public funding, a significant amount of which came from the pharmaceutical industry. Only one CT reported the low economic and educational level of its participants. Furthermore, none of the authors of the reviewed CTs declared conflicts of interest. Although the axiology of techno-science always takes into account at least the epistemic, technical and economic value systems, the hegemony of the economic values imposed by the pharmaceutical industry is evident in the performance of CTs investigating the treatment of periodontitis in LMI countries.

Impact of global budget combined with pay-for-performance on the quality of care in county hospitals: a difference-in-differences study design with a propaensity-score-matched control group using data from Guizhou province, China.

BACKGROUND: Provider payment system has a profound impact on health system performance. In 2016, a number of counties in rural Guizhou, China, implemented global budget (GB) for county hospitals with quality control measures. The aim of this study is to measure the impact of GB combined with pay-for-performance on the quality of care of inpatients in county-level hospitals in China. METHODS: Inpatient cases of four diseases, including pneumonia, chronic asthma, acute myocardial infarction and stroke, from 16 county-level hospitals in Guizhou province that implemented GB in 2016 were selected as the intervention group, and similar inpatient cases from 10 county-level hospitals that still implemented fee-for-services were used as the control group. Propensity matching score (PSM) was used for data matching to control for age factors, and difference-in-differences (DID) models were constructed using the matched samples to perform regression analysis on quality of care for the four diseases. RESULTS: After the implementation of GB, rate of sputum culture in patients with pneumonia, rate of aspirin at discharge, rate of discharge with ß-blocker and rate of smoking cessation advice in patients with acute myocardial infarction increased. Rate of oxygenation index assessment in patient with chronic asthma decreased 20.3%. There are no significant changes in other indicators of process quality. CONCLUSIONS: The inclusion of pay-for-performance in the global budget payment system will help to reduce the quality risks associated with the reform of the payment system and improve the quality of care. Future reform should also consider the inclusion of the pay-for-performance mechanism.

Total health insurance costs in children with a migraine diagnosis compared to a control group.

BACKGROUND: Health care costs of migraine constitute a major issue in health economics. Several publications analyzed health care costs for adult migraine patients, based on questionnaires or secondary (health insurance) data. Although migraine often starts already in primary school age, data on migraine related costs in children is scarce. In this paper we aimed to assess the migraine-related health care costs in 6 to 11 year old children in Germany. METHODS: Using claims data of a large German health insurer (BARMER), overall annual health care costs of 6 to 11 year old children with a diagnosis of migraine in 2017 (n = 2597) were compared to a control group of 6 to 11 year old children without a headache diagnosis between 2013 and 2017 (n = 306,926). The association of migraine and costs was modeled by generalized linear regression (Gamma regression) with adjustment for sex, age and comorbidities. RESULTS: Children with migraine caused considerably higher annual per capita health care costs than children without a headache diagnosis (migraine group: € 1018, control group: € 618). Excess costs directly related to migraine amounted to € 115. The remaining excess costs were related to comorbidities, which were more frequent in the migraine group. Mental and behavioural disorders constituted the most expensive comorbidity, accounting for € 105 of the € 400 annual excess costs in the migraine group. CONCLUSION: 6 to 11 year old children with a migraine diagnosis cause significant direct and comorbidity related excess costs in the German health care system.

Study on Overload Injuries during Periods of Intense Physical Activity Complemented by Isokinetic Dynamometry Evaluation / Estudo das lesões de sobrecarga durante período intenso de atividade física complementado com avaliação por dinamometria isocinética

Abstract Objective The present study aims to measure the incidence of overload injuries in training soldiers, who are subjected to intense physical exercise, and to compare it with a control group. Next, it intends to verify whether there is any relationship between overload injuries and some neuromuscular function parameters. Methods Analytical, prospective observational study. Both the observational and the control group consisted of soldiers from the Portuguese Army. Clinical evaluation was performed by medical interview in the week prior to the beginning of a military parachuting course and in the week immediately after its completion. The neuromuscular performance was assessed by isokinetic dynamometry during the medical interview. Results With 44 of the 57 military personnel in training complaining of pain, the observational group had significantly more injuries than the control group (p< 0.001). Five complaints had traumatic origin and 39 were overload injuries. Of the 39 military personnel with overload injuries, 21 reported limited sports performance. However, isokinetic dynamometry showed no statistically significant differences in neuromuscular performance (p = 0.223 and p = 0.229). Conclusion Military personnel in training are prone to overload injuries, with an incidence rate > 70%. The implementation of strategies for injury monitoring and prevention is critical to promote health and physical capacity.

Resumo Objetivo Os autores pretendem medir a incidência de lesões de sobrecarga em militares em formação, que são submetidos a exercício físico intenso, e compará-la com um grupo controle. Posteriormente, pretende-se verificar se existe alguma relação entre a ocorrência de lesões de sobrecarga e alguns parâmetros da função neuromuscular. Métodos Estudo observacional prospectivo analítico. Grupo de observação e grupo controle constituídos por militares do Exército Português. A avaliação clínica foi feita por entrevista médica na semana que antecede o início do curso de paraquedismo militar e na semana imediatamente após o final do curso. Em simultâneo com a entrevista médica, foi realizada a avaliação da performance neuromuscular através da dinamometria isocinética. Resultados Com 44 dos 57 militares em formação a referir queixas álgicas, o grupo de observação apresentou significativamente mais lesões que o grupo controle (p < 0.001). Cinco queixas foram de origem traumática e 39 foram lesões de sobrecarga. Dos 39 militares com lesões de sobrecarga, 21 referiram limitação do rendimento esportivo. No entanto, na avaliação por dinamometria isocinética, não se verificaram diferenças estatisticamente significativas na evolução da performance neuromuscular (p = 0.223 e p = 0.229). Conclusão Os militares em formação são indivíduos propensos a sofrerem lesões de sobrecarga, tendo-se obtido uma taxa de incidência de lesões de sobrecarga na ordem dos 70%. A implementação de estratégias de monitoração e prevenção das lesões são fundamentais na promoção da saúde e da capacidade física.

Functional Outcomes of Arthroscopic Treatment in Femoroacetabular Impingement in Patients over 60 Years Old Compared with Patients Aged 40 Years or Younger / Resultados funcionais do tratamento artroscópico no impacto femoroacetabular em pacientes com mais de 60 anos em comparação com pacientes com 40 anos ou menos

Abstract Objective To evaluate the functional outcomes of patients diagnosed with femoroacetabular impingement (FAI) older than 60 years, compared with those of patients of age 40 years or younger. Methods This was a retrospective review of patients with FAI who underwent hip arthroscopy between 2010 and 2015. The patients were adults aged over 60 years with Tönnis ≤ 1 matched in a 1:1 ratio with adults aged 40 years or younger, according to the type of deformity (cam, pincer, or mixed), sex, and the date when the surgery was performed. Results Thirty-four patients were included in each group. The mean age was 30.6 ± 6.9 years and 65.6 ± 4.6 years in the control and case groups, respectively. There were no significant differences between the groups at 1-year follow-up (p > 0.05). In the group with older patients (case group), we observed a change in the total Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score from 46.3 to 22.0 in the 1st postoperative year, while the control cases improved in the WOMAC score from 38.1 to 7.2 in relation to the preoperative stage. Conclusion In the group of patients ≤ 40 years old, a considerable change was observed in the WOMAC score without a statistical significance compared with the > 60 years group. This observation suggests that hip arthroscopy is beneficial when there is an appropriate selection of patients with FAI, regardless the age of the patient.

Resumo Objetivo Avaliar os resultados funcionais de pacientes diagnosticados com impacto femoroacetabular (IFA) e com mais de 60 anos de idade em comparação aos resultados de pacientes com até 40 anos de idade. Métodos Esta é uma revisão retrospectiva de pacientes com IFA submetidos à artroscopia do quadril entre 2010 e 2015. Os pacientes eram adultos com mais de 60 anos de idade e Tönnis ≤ 1, alocados na proporção de 1:1 com adultos de até 40 anos de idade, de acordo com o tipo de deformidade (came, pincer, ou misto), sexo e data de realização da cirurgia. Resultados Trinta e quatro pacientes foram incluídos em cada grupo. A idade média foi de 30,6 ± 6,9 anos e 65,6 ± 4,6 anos nos grupos controle e de casos, respectivamente. Não houve diferenças significativas entre os grupos no acompanhamento de 1 ano (p > 0.05). No primeiro ano após a cirurgia, a pontuação Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) passou de 46,3 para 22,0 no grupo de pacientes mais velhos (casos) e de 38,1 para 7,2 no grupo controle em comparação ao estágio pré-operatório. Conclusão O grupo de pacientes com até 40 anos de idade apresentou uma mudança considerável na pontuação WOMAC, mas sem significado estatístico em comparação ao grupo de pacientes acima de 60 anos. Essa observação sugere que a artroscopia do quadril é benéfica quando a seleção de pacientes com IFA é apropriada, independentemente da idade dos indivíduos.

Effects of a work-related stress model based mental health promotion program on job stress, stress reactions and coping profiles of women workers: a control groups study.

BACKGROUND: Work-related stress and its detrimental effects on human health have rapidly increased during the past several years. It causes many different stress reactions, related diseases and unhealthy behavior among workers, but especially women workers. Thus, the aim of this study was to examine the effects of the work-related stress model based Workplace Mental Health Promotion Programme on the job stress, social support, reactions, salivary immunoglobulin A and Cortisol levels, work absenteeism, job performance and coping profiles of women workers. METHODS: This study had a "pre-test post-test non-equivalent control groups" design and included 70 women workers (35 in each study group) selected by randomized sampling from two factories. The programme was delivered as an intervention including 12 weeks of follow-up. Reminder messages, videos, and WhatsApp texts were used at the follow-up stage. The research measurements were; the assessment form, the Brief Job Stress Questionnaire, the Brief Coping Profile Scale, salivary ELISA kits, and a self-reported check-list. RESULTS: There were no differences in sociodemographic characteristics, general health or working conditions between the Intervention and control groups(p > .05). Three months after the intervention, there was a significant decrease in job stress(p ≤ .001), physical and mental reactions' scores(p ≤ .001) and work absenteeism(p < .05), and there was an increase in job performance(p < .05), social support(p ≤ .001) among the intervention group. The programme showed positive effects on coping profiles(p < .05). After the intervention salivary-cortisol and IgA levels showed a statistically significant decrease(p < .05). A majority of effect sizes were very large (ηp2 > .14). CONCLUSIONS: Work-ProMentH was found to be effective and useful in job stress management and promotion of effective coping profiles. It enables its users to holistically assess worker stress and to plan and examine intervention programmes via a systematic approach. There is a need for more empirical studies that may support the data of the present study, but it is thought that the intervention can be maintained for the long-term. We recommend that occupational health professionals at workplaces should consider using this model-based cost-effective intervention, which seems easy and practical to apply in real-life situations. TRIAL REGISTRATION: ISRCTN registration ID: ISRCTN14333710 (2020/10/03, retrospective registration).