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To develop two ethical checklists to evaluate (i) management of ethical concerns in research projects and (ii) awareness of ethical conduct of healthcare laboratory professionals. Comprehensive discussion among the members of IFCC Task Force on Ethics based on pertinent literature. This Checklist for Clinical Research Projects should be useful to evaluate research proposals from an ethical perspective before submitting it to an IRB or its equivalent, thereby diminishing rejection rates and resulting in more time-effective projects. The checklist designed to evaluate the ethical conduct in laboratory medicine could be useful for self evaluation (internal audits) and for certification/accreditation processes performed by third parties. These checklists are simple but powerful tools useful to guide professionals to adhere to ethical principles in their practice, especially in developing countries where accredited ethics committees may be difficult to find. [ABSTRACT FROM AUTHOR]

Purpose: To analyze outcomes after multiple light redirection (MLR) by photoablation of a small paracentral portion of Bowman's layer in each corneal quadrant using standard myopic laser in situ keratomileusis (LASIK) software with non-customized fenestrated MLR corneal light shields (Excimer-MLR) without postoperative visual training or magnification in pseudophakic eyes with central visual loss from age-related macular degeneration (AMD) with geographic atrophy (GA). Methods: Retrospective analysis of two cases. Results: Outcomes after Excimer-MLR in the worse-seeing eyes of an 86-year-old and a 65-year-old pseudophakic man with AMD and GA revealed corrected distance/near visual acuity gains of 6.0/6.0 and 11.8/10.0 lines within 12 days and 5.0/5.0 and 12.2/9.8 lines at 9 months, respectively, with improved Amsler grids, no distance or near glasses change, no complications, and no adverse events related to Excimer-MLR. Contrast sensitivity and stereopsis, measured in case 2, improved postoperatively. Conclusions: This first report showed that Excimer-MLR safely produced large improvements in visual function up to 9 months postoperatively in two eyes with central visual loss from AMD. [Journal of Refractive Surgery Case Reports. 2024;4(4):e29–e35.] [ABSTRACT FROM AUTHOR]

Screening, Brief Intervention, and Referral to Treatment (SBIRT) is an evidence-based practice that provides early integrated intervention and treatment to patients with Alcohol Use Disorder (AUD) and/or Substance Use Disorders (SUD). Three Primary Care Medical Homes (PCMHs) in North Texas were selected as pilot sites for a SAMHSA grant designed to integrate SBIRT into existing services. The goal of this program is to support the stabilization and community reintegration of individuals who present with SUD by providing them with a continuum of care from screening, to brief intervention, to brief treatment, to referral for more advanced services. Specific aims of the grant included: provide SBIRT services to eligible participants, decrease substance and alcohol use at 6-month follow-up, improve patient physical and behavioral health measured at 6 months, and decrease in emergency department visits and costs for program participants. This brief report examines project design, outlines the implementation strategies, and provides preliminary results. [ABSTRACT FROM AUTHOR]

The origins of the notion of matchings in groups spawn from a linear algebra problem proposed by E. K. Wakeford [On canonical forms. Proc London Math Soc (2). 1920;18:403–410] which was tackled in Fan and Losonczy [Matchings and canonical forms for symmetric tensors. Adv Math. 1996;117(2):228–238]. In this paper, we first discuss unmatchable subsets in abelian groups. Then we formulate and prove linear analogues of results concerning matchings, along with a conjecture that, if true, would extend the primitive subspace theorem. We discuss the dimension m-intersection property for vector spaces and its connection to matching subspaces in a field extension, and we prove the linear version of an intersection property result of certain subsets of a given set. [ABSTRACT FROM AUTHOR]

We extend the existing literature on gender differences in competitive behavior by investigating tournament entry choices when a principal decides for an agent. In a laboratory experiment, we randomly assign subjects the role of either principal or agent. The principal decides whether the agent performs a real-effort task under piece-rate or tournament incentives. When deciding, the principal is informed about the agent's previous performance, age, and residency. Between treatments, we vary whether the principal knows the agent's gender. In a baseline treatment, we replicate the standard setting in which subjects decide for themselves whether to compete. Our main findings are, first, that there is no gender gap in tournament entry when principals decide for agents as opposed to the baseline treatment. Second, the gender gap closes because more women are made to compete by principals. Third, whereas there is no gender gap in either of the principal treatments, revealing the agent's gender is associated with higher overall tournament entry rates. Exploratory analyses of principals' choice determinants reveal a positive effect of preferences to take risks, competitiveness, and confidence in agents' performances on making agents compete. In addition, we find no difference in how principals evaluate male and female agents' performances. Finally, we test the efficiency of principals' competition choices and show that they lead to fewer payoff-maximizing outcomes than when subjects decide for themselves. Additionally, overall tournament performances and winners' performances are lower when agents are made to compete, but this effect is not robust to controlling for agents' previous performances. This paper was accepted by Yan Chen, behavioral economics and decision analysis. Funding: This work was supported by L. Meltzers Høyskolefond; Austrian Science Fund [Grant SFB F63 "Credence Goods, Incentives and Behavior"], and the Department of Economics at the University of Bergen. Also, we are grateful for funding from the Equal Opportunity Coordination Office of the University of Regensburg and its faculty of Business and Economics. Supplemental Material: The supplementary online material and data are available at https://doi.org/10.1287/mnsc.2022.4413. [ABSTRACT FROM AUTHOR]

Lower fine motor performance in childhood has been associated with poorer cognitive development and neurodevelopmental conditions such as autism spectrum disorder, yet, biological underpinnings remain unclear. DNA methylation (DNAm), an essential process for healthy neurodevelopment, is a key molecular system of interest. In this study, we conducted the first epigenome-wide association study of neonatal DNAm with childhood fine motor ability and further examined the replicability of epigenetic markers in an independent cohort. The discovery study was embedded in Generation R, a large population-based prospective cohort, including a subsample of 924 ~ 1026 European-ancestry singletons with available data on DNAm in cord blood and fine motor ability at a mean (SD) age of 9.8 (0.4) years. Fine motor ability was measured using a finger-tapping test (3 subtests including left-, right-hand and bimanual), one of the most frequently used neuropsychological instruments of fine motor function. The replication study comprised 326 children with a mean (SD) age of 6.8 (0.4) years from an independent cohort, the INfancia Medio Ambiente (INMA) study. Four CpG sites at birth were prospectively associated with childhood fine motor ability after genome-wide correction. Of these, one CpG (cg07783800 in GNG4) was replicated in INMA, showing that lower levels of methylation at this site were associated with lower fine motor performance in both cohorts. GNG4 is highly expressed in the brain and has been implicated in cognitive decline. Our findings support a prospective, reproducible association between DNAm at birth and fine motor ability in childhood, pointing to GNG4 methylation at birth as a potential biomarker of fine motor ability. [ABSTRACT FROM AUTHOR]

Background Parental education is one of the best predictors of child school achievement. Higher parental education is not only associated with higher child intelligence, but children from highly educated parents also perform better in school due to other family related factors. This study evaluates the relation between parental education, child non-verbal intelligence and parenting practices with child school achievement. Methods Longitudinal data from a large population-based, multi-ethnic cohort of children in the Netherlands (63% Dutch origin) followed from birth to age 13 years (3547 children; 52.3% girls) were analyzed. School achievement was measured at the end of primary school (12 years of age) with a national Dutch academic test score. Parental education was assessed at age 3 years. The non-verbal intelligence of the child was measured at age 6 years and a full intelligence was measured at age 13 years. Maternal and paternal family routines, harsh parenting and corporal punishment were assessed in early and mid-childhood. Mediation analysis was performed with the G-formula and Structural Equation Models. Results Child intelligence partially mediated [B indirect effect =0.54 95% CI (0.46, 0.62) P  < 0.001] the association between parental education and child school achievement. Independent of intelligence, family routines [B indirect effect =0.04 95% CI (0.01, 0.07) P  < 0.01], but not harsh parenting mediated this association. Conclusions Higher parental education was associated with better school achievement through two independent mechanisms, through higher intelligence of the child and parenting practices. [ABSTRACT FROM AUTHOR]

Background: Women bear a heavier burden of the consequences related to prescription opioid use compared to their male counterparts; however, there has been little attention in the literature regarding prescription opioid use among women. We aimed to examine risk factors for prescription opioid use among women. Methods: Demographics, health status, and substance use data, including prescription opioid use, were collected through a community engagement program, HealthStreet, during a health needs assessment. Women older than 18 years were classified by opioid use: past 30-day, lifetime, but not past 30-day, or no lifetime prescription opioid use. Descriptive statistics and chi-square tests were calculated, and multinomial logistic regression was used to calculate adjusted odds ratios (aORs; confidence interval [CI]). Results: Among 5,549 women assessed, 15% reported past 30-day use and 41% reported lifetime use of prescription opioids. While prescription sedative use was the strongest risk factor for past 30-day use among younger women (aOR = 4.84; 95% CI, 3.59–6.51), past 6-month doctor visits was the strongest risk factor for past 30-day use among older women (aOR = 4.15; 95% CI, 2.62–6.60). Conclusions: We found higher rates of prescription opioid use in this community sample of women compared to national rates. Risk factors for recent prescription opioid use (past 30-day use) differed among older and younger women. Clinicians should be more vigilant about prescribing opioids as the medical profile for women may change through age, especially the co-prescribing of opioids and sedatives. [ABSTRACT FROM AUTHOR]

Why choose less money over more when no one is watching? A central tenet of economics is that this behaviour can be explained by intrinsic motivation. But what does intrinsic motivation entail? What encourages it? This paper answers these questions through a Smithian lens: moral motivation includes not only a naturally strong love of praise and dread of blame but also a natural, and stronger, love of being worthy of praise and dread of being worthy of blame, even if neither is necessarily given. I rely on quantitative and qualitative data from economic experiments to illustrate this claim. While the current scholarship on Smith has applied his theory to situations in which our actions either evoke reactions from others or have monetary consequences for them, I extend his insights to receiver games (Tjøtta 2019) and dice-rolling games (Fischbacher and Föllmi-Heusi 2013) aimed at eliciting self-regarding concerns, that is, actions affecting the interests of only ourselves. I argue that these games accentuate the strength of the love of praiseworthiness in guiding behaviour, emphasising its immediate reference to others and foundation in intentions along with outcomes. [ABSTRACT FROM AUTHOR]

Recent studies have shown that there are systematic differences among total and free prostate-specificantigen (PSA) immunoassays. In this study we analyzedintermethod differences in total PSA (tPSA) and free PSA(fPSA) measurement using ARCHITECT i2000SR (Abbott Diagnostics) and COBAS E601 (Roche Diagnostics). A number of 160 blood samples were tested for tPSA and 50 samples for fPSA (selecting only sampleswith tPSA: 4.1–10.0 μg/L). Passing–Bablok regression analysis was used to compare the two analytical methods fortPSA, fPSA and percentage of fPSA (%fPSA). A strong correlation was noticed between ARCHITECT i2000SR and COBAS E601 for tPSA, fPSA and %fPSA (r between 0.94 and 0.99). Concentrations of tPSA and fPSA measured by COBAS E601 were higher thanthose measured by ARCHITECT i2000SR with a bias of 0.8 μg/L for tPSA and 0.14 μg/L for fPSA. Analyzing therelative difference between methods for fPSA and %fPSA, COBAS E601 exceed a 10% relative difference limit. Our study confirms that there are differences in measured concentrations of tPSA and fPSA byvarious commercial methods. Because clinical judgment on subsequent diagnostic procedures, such as prostatebiopsy, is based on tPSA and fPSA results, tests harmonization should be a priority. [ABSTRACT FROM AUTHOR]

Non-medical use (NMU) of prescription opioids is of concern due to the opioid epidemic in the United States. Objective: We examined sex differences in the effect of age of first use of prescription opioids on prescription opioid NMU among 17- and 18-year olds. Methods: The National Monitoring of Adolescent Prescription Stimulants Study (N-MAPSS) recruited youth 10–18 years from 10 United States cities between 2008 and 2011 (n = 11,048). The cross-sectional survey included questions on past 30 day prescription opioid use (10,965 provided responses; 278 age 17 to 18 years who used opioids in past 30 days), with NMU defined as non-oral use and/or use of someone else's opioids. Nonparametric survival analysis with lifetable estimates was used to examine age at first use. Binomial logistic regression was conducted predicting any NMU, adjusted for covariates. Results: Among 278 youth 17 to 18 years, a significant difference in age of first use between those with MU only and any NMU (p <.0001) was observed. Each one year increase in age resulted in a 33% decrease in the odds of any prescription opioid NMU compared to MU only, after controlling for covariates (Odds Ratio = 0.67, 95% Confidence Interval: 0.47,0.96). Sex differences in age at first use were not observed. Conclusions: Risk of past 30 day prescription opioid NMU decreased by a third for each one year increase in age of first use, after adjustment for other covariates. Use of prescription opioids in young adolescents may need to be limited where possible and researched further. [ABSTRACT FROM AUTHOR]

Although results of animal research show that interactions between stress and sex hormones are implicated in the development of affective disorders in women, translation of these findings to patients has been scarce. As a basic step toward advancing this field of research, we analyzed findings of studies which reported circulating cortisol levels in healthy women in the follicular vs. luteal phase of the menstrual cycle. We deemed this analysis critical not only to advance our understanding of basic physiology, but also as an important contrast to the findings of future studies evaluating stress and sex hormones in women with affective disorders. We hypothesized that cortisol levels would be lower in the follicular phase based on the proposition that changes in levels of potent GABAergic neurosteroids, including allopregnanolone, during the menstrual cycle dynamically change in the opposite direction relative to cortisol levels. Implementing strict inclusion criteria, we compiled results of high-quality studies involving 778 study participants to derive a standardized mean difference between circulating cortisol levels in the follicular vs. luteal phase of the menstrual cycle. In line with our hypothesis, our meta-analysis found that women in the follicular phase had higher cortisol levels than women in the luteal phase, with an overall Hedges' g of 0.13 (p < 0.01) for the random effects model. No significant between-study difference was detected, with the level of heterogeneity in the small range. Furthermore, there was no evidence of publication bias. As cortisol regulation is a delicate process, we review some of the basic mechanisms by which progesterone, its potent metabolites, and estradiol regulate cortisol output and circulation to contribute to the net effect of higher cortisol in the follicular phase. [ABSTRACT FROM AUTHOR]

Background: Non-medical use of prescription drugs is a major public health concern in the United States. Prescription opioids and sedatives are among the most widely abused drugs and their combined use can be lethal. Increasingly rigid prescribing guidelines may contribute to the changing context of opioid use and increase drug diversion.Objective: To examine gender differences in diversion of prescription opioids and sedatives among non-medical prescription opioid and sedative polysubstance users. We hypothesize that men will be more likely than women to engage in incoming diversion.Methods: Data from the Prescription Drug Abuse, Misuse, and Dependence Study, a cross-sectional study focused on prescription drug users, were analyzed. Non-medical use was defined as use of a drug that was not prescribed or use in a way other than prescribed. Individuals who reported past 12-month non-medical opioid and sedative use were included; diversion was defined as incoming (obtaining drugs from a source other than a health professional) and outgoing (giving away/selling/trading prescription drugs).Results: Among the 198 polysubstance users, 41.4% were female. Men were 2.85 times as likely as women to report incoming diversion (95% CI: 1.21-6.72). Women were more likely to obtain opioids from a healthcare professional; men were more likely to obtain sedatives from a roommate, coworker, or friend. Over half of men and women reported outgoing diversion opioids or sedatives.Conclusion: Drug diversion highlights an important point of intervention. Current prevention efforts that target prescribers should be expanded to include users and diversion activities; these interventions should be gender-specific. [ABSTRACT FROM AUTHOR]

Parental separation is a major adverse childhood experience. Parental separation is generally preceded by conflict, which is itself a risk factor for child problem behavior. Whether parental separation independent of conflict has negative effects on child problem behavior is unclear. This study was embedded in Generation R, a population-based cohort followed from fetal life until age 9 years. Information on family conflict was obtained from 5,808 mothers and fathers. The 4-way decomposition method was used to apportion the effects of prenatal family conflict and parental separation on child problem behavior into 4 nonoverlapping components. Structural equation modeling was used to test bidirectional effects of child problem behavior and family conflict over time. Family conflict from pregnancy onward and parental separation each strongly predicted child problem behavior up to preadolescence according to maternal and paternal ratings. Using the 4-way decomposition method, we found evidence for a strong direct effect of prenatal family conflict on child problem behavior, for reference interaction, and for mediated interaction. The evidence for interaction implies that prenatal family conflict increased the children's vulnerability to the harmful effect of parental separation. There was no evidence of a pure indirect effect of parental separation on child problem behavior. Overall, results indicated that if parental separation occurs in families with low levels of conflict, parental separation does not predict more child problem behavior. Moreover, the bidirectional pattern suggested that child problem behavior influences the persistence of family conflict. [ABSTRACT FROM AUTHOR]

Background: Previous studies have shown that poor family environments are related to more sleep problems; however, little is known about how family irregularity in early life affects the development of sleep problems over childhood using objective sleep measures. The current study tests the hypothesis that early family irregularity contributes to the development of sleep problems. Methods: This population‐based study comprises 5,443 children from the Generation R Study. Family irregularity was measured with seven maternal‐reported questions on family routines when children were 2 and 4 years old. Mothers reported on sleep problems at child age 3, 6, and 10 years, whereas children completed questionnaires on sleep problems at age 10. Additionally, we used tri‐axial wrist accelerometers for five nights in 851 children (mean age 11.7 years) to assess sleep objectively. Results: Family irregularity was associated with more mother‐ and child‐reported sleep problems at ages 3, 6, and 10 years as well as with a shorter sleep duration and later objective sleep onset, but not with sleep efficiency or waking time. The association between family irregularity and multi‐informant subjective sleep problems at age 10 years was mediated by mother‐reported child psychopathology at age 6 years. Conclusions: Our findings show a long‐term robust association of preschool family irregularity with more sleep problems during childhood as well as shorter sleep duration and later sleep onset as measured objectively with actigraphy. In part, these sleep problems were associated with family irregularity by way of child psychopathology. These findings suggest that interventions improving preschool family irregularity, which are targeted to reduce child psychopathology, may also impact the development of sleep problems beneficially. [ABSTRACT FROM AUTHOR]

Concurrent use of prescription medications and alcohol is prevalent among older adults and impacts women more than men, however little is known about characteristics of older women who use both. The current analysis aims to evaluate those characteristics. Participants were recruited through HealthStreet, an outreach program. Community health workers (CHWs) assess health needs and concerns among community members. CHWs collect demographic, substance use, and other health data from participants. Female participants (≥ 50 years) interviewed November 2011-November 2017 were included and stratified into four groups: neither prescription opioid nor hazardous alcohol use (three or more drinks in a single day), hazardous alcohol use only, prescription opioid use only, and both prescription opioid and hazardous alcohol use. Chi square and ANOVA tests were used to compare these groups. Among the 2370 women (53% black; mean age 61 years), 70% reported neither prescription opioid nor hazardous alcohol use, 12% reported hazardous alcohol use only, 15% reported prescription opioid use only, and 3% reported use of both in the past 30 days. Concurrent prescription opioid and hazardous alcohol use were significantly associated with comorbid depression and anxiety (p < 0.0001); women who endorsed prescription opioid use only were significantly more likely to report a history of back pain, cancer, or diabetes compared to their counterparts (p < 0.0001). Nearly a third of women reported prescription opioid and/or hazardous alcohol use in the past 30 days. Because the risk and consequences of concomitant alcohol and opioid use increase with age, interventions tailored to women are needed. [ABSTRACT FROM AUTHOR]

Introduction: Carcinoembryonic antigen (CEA) is used for monitoring of disease progression and treatment response in cancer patients. The aim was to compare the performance of chemiluminescent microparticle immunoassay with electrochemiluminescence immunoassay for CEA. Methods: A total of 115 samples were collected during routine diagnostic, prognostic, and therapy monitoring procedures in patients with colorectal and pancreatic cancer. We used Architect i2000SR and Cobas E601 for CEA analysis in sera samples. Results: The correlation coefficient of 0.984 (95% confidence interval [CI]: 0.972-0.991) for results obtained on both platforms was observed for CEA ≤10 ng/mL group. Moreover, intercept of 0.9027 (95% CI: 0.705-1.099) and slope 0.8076 (95% CI: 0.765-0.8498) (p < 0.0001) were observed in this group. In CEA >10 ng/mL group, we observed slope = 1.1986 (95% CI: 1.1474-1.2498) (p < 0.0001), intercept = -11.69 (-17.53--5.84), and correlation coefficient = 0.985 (95% CI: 0.976-0.9914). Mean differences between assays in group ≤10 ng/mL and >10 ng/mL were 0.2066 (95% CI: 0.0019-0.4113) and -2.66 (95% CI: -10.10-4.76) ng/mL, respectively. Conclusion: Although there were differences, based on 20 days' precision tests, overall results showed a good analytical performance and correlation between CEA assays on Architect i2000SR and Cobas E601 platforms. Reference intervals appropriate for the method of CEA measurement should be used. The standardization and harmonization of serum CEA concentration assays are needed. [ABSTRACT FROM AUTHOR]

In a longitudinal population-based study of 2,905 children, we investigated if infants' neuromotor development was associated with autistic traits in childhood. Overall motor development and muscle tone were examined by trained research assistants with an adapted version of Touwen's Neurodevelopmental Examination between ages 2 and 5 months. Tone was assessed in several positions and items were scored as normal, low, or high tone. Parents rated their children's autistic traits with the Social Responsiveness Scale (SRS) and the Pervasive Developmental Problems (PDP) subscale of the Child Behavior Checklist at 6 years. We defined clinical PDP if scores were >98th percentile of the norm population. Diagnosis of autism spectrum disorder (ASD) was clinically confirmed in 30 children. We observed a modest association between overall neuromotor development in infants and autistic traits. Low muscle tone in infancy predicted autistic traits measured by SRS (adjusted beta = 0.05, 95% CI for B: 0.00-0.02, P = 0.01), and PDP (adjusted beta = 0.08, 95% CI for B: 0.04-0.10, P < 0.001). Similar results emerged for the association of low muscle tone and clinical PDP (adjusted OR = 1.36, 95% CI: 1.08-1.72, P = 0.01) at age 6 years. Results remained unchanged if adjusted for child intelligence. There was no association between high muscle tone and SRS or PDP. Exclusion of children with ASD diagnosis did not change the association. This large study showed a prospective association of infant muscle tone with autistic traits in childhood. Our findings suggest that early detection of low muscle tone might be a gateway to improve early diagnosis of ASD. Autism Res 2017, 10: 757-768. © 2017 International Society for Autism Research, Wiley Periodicals, Inc. [ABSTRACT FROM AUTHOR]

Within a population-based study of 3356 children, we investigated whether infant neuromotor development was associated with cognition in early childhood. Neuromotor development was examined with an adapted version of Touwen's Neurodevelopmental Examination between 9 and 20 weeks. Parents rated their children's executive functioning at 4 years. At age 6 years, children performed intelligence and language comprehension tests, using Dutch test batteries. At age 6-9 years, neuropsychological functioning was assessed in 486 children using the validated NEPSY- II- NL test battery. We showed that less optimal neurodevelopment in infancy may predict poor mental rotation, immediate memory, shifting, and planning; but not nonverbal intelligence or language comprehension. [ABSTRACT FROM AUTHOR]

In primary care, collecting information about patient health behaviors between appointments can be advantageous. Physicians and researchers who embrace phone-based technology may find valuable ways to monitor patient-reported outcome measures of health (PROM). However, the level of phone technology sophistication should be tailored to the phone use of the population of interest. Despite the growing use of telephones as a means to gather PROM, little is known about phone use among primary care patients. As part of an ongoing study, the authors recruited primary care patients (N = 9126) for a health behavior screening study by calling them on the primary contact number listed in their medical record. The current study evaluated the frequency with which individuals were reached on landlines, basic cell phones, and smartphones, and examined participant characteristics. The majority of participants (63%) used landlines as their primary contact. Of the 37% using cell phones on the recruitment call, most (71%) were using smartphones. Landline users were significantly older than cell phone users (61.4 vs. 46.2 years; P = .001). Cell phone use did not differ significantly between participants with a college education and those without (37% vs. 38%; P = .82); however, smartphone use did differ (61% vs. 77%; P = .01). The majority of participants sampled used landlines as their primary telephone contact. Researchers designing phone-based PROM studies for primary care may have the broadest intervention reach using interactive voice response telephone technology, as patients could report health outcomes from any type of phone, including landlines. ( Population Health Management 2016;19:212-215) [ABSTRACT FROM AUTHOR]

Objective.To investigate the potential role of interleukin 4 (IL-4), interleukin 10 (IL-10) and high-sensitivity C-reactive protein (hs-CRP) as serum biomarkers of persistent/recurrent disease in papillary thyroid carcinoma (PTC) with/without Hashimoto's thyroiditis (HT).Methods.Eighty consecutive patients (64 F/16 M, 43.2 ± 12.7 years) with PTC and 40 (37 F/3 M, 40.6 ± 12.3 years) with papillary thyroid carcinoma associated with Hashimoto's thyroiditis (PTC + HT) were evaluated before radioiodine therapy. A control group of 20 patients with HT without thyroid cancer (18 F/2 M, 47.3 ± 2.8 years) was included in the study for the comparison of cytokine levels.Results.No meaningful differences were found in clinical outcomes between PTC and PTC + HT groups (47.5% vs. 45% persistent/recurrent disease). Serum IL-4, IL-10 and hs-CRP levels were higher in patients with persistent/recurrent disease compared to those without recurrence (p< 0.001). IL-4, IL-10 and hs-CRP were also found in substantially higher concentrations in PTC + HT patients with persistent/recurrent disease than in patients with HT or PTC (with or without recurrence) (p< 0.01). Positive correlations were observed between IL-4, IL-10, hs-CRP and thyroglobulin (Tg) (rbetween 0.48 and 0.56,p< 0.005) or antithyroglobulin antibodies (TgAb) (rbetween 0.63 and 0.80,p< 0.002) in PTC and PTC + HT patients with persistent/recurrent disease.Conclusions.Increased levels of serum IL-4, IL-10 and hs-CRP are associated with persistent/recurrent disease in PTC and PTC + HT patients. Our results suggest that these biomarkers might be used to improve patient stratification according to the risk of recurrence, especially in patients with PTC + HT, where Tg levels are not reliable due to presence of TgAb. [ABSTRACT FROM PUBLISHER]

This study uses data from the population-based Generation R Study of Rotterdam, the Netherlands, to assess an association of genetic risk for schizophrenia and bipolar disorder with infant neuromotor development. [ABSTRACT FROM AUTHOR]

Introduction: The diagnostic utility of B-type natriuretic peptide (BNP) has prompted interest in its use as an aid in the detection of early heart failure and assessment of diseases. The first objective of this study was measurement of BNP and troponin I (TnI) blood levels in patients with acute myocardial infarction (AMI) and unstable angina. The second objective of this study was to find a correlation between TnI and BNP in blood. Methods: The concentrations of BNP and TnI in 150 blood levels were determined using CMIA (chemiluminescent microparticle immunoassay) Architect and 2000 (Abbott diagnostics). The retrospective study included 100 patients who were hospitalized at the Department of Internal Medicine of the University Clinical Center Sarajevo and 50 healthy control. The reference blood range of BNP is 0-100 pg/mL and TnI is 0.00-0.4 ng/mL. Results: In the patients with AMI the mean value of BNP is 764.48 ± 639.52 pg/mL and TnI is 2.50 ± 2.28 ng/mL. The patients with unstable angina have BNP 287.18 ± 593.20 pg/mL and TnI 0.10 ± 0.23 ng/mL. Our studies have shown that the correlation between BNP and TnI was statistically significant for p < 0.05 using Student t test with correlation coefficient r = 0.36. Conclusions: BNP and TnI levels can help to identify the patients with a high risk for cardiovascular diseases. [ABSTRACT FROM AUTHOR]

Motivational interviewing (MI) is an evidence-based psychotherapeutic approach to health behavior change and has great potential to improve medical regimen adherence among the older population. This article provides a concise summary of MI as it can be applied to geriatric patient populations. The goal is to provide readers with an overview of MI, its clinical applications within psychological and medical settings and its adaptation for use with older individuals dealing with both mental health and general medical conditions. The article also discusses how varied systemic and therapeutic contexts (e.g., biomedical vs. psychological) may affect the meaning and implementation of MI. Although published randomized controlled studies on the effects of MI in the older population are limited, the majority of such studies indicates that MI is effective in influencing change in health behaviors. As a proven, cost-efficient treatment, MI should be considered for clinical use in geriatric and primary care clinics providing care to older adults. [ABSTRACT FROM AUTHOR]

The recovery model of mental health has gained momentum in the last three decades as a guiding philosophy for the transformation of traditional mental health institutions into programmes that are more responsive to consumer needs and choices. Recovery has served as a framework for our ongoing efforts to transform a psychiatric institution into a model programme for similar organizations in the state of Georgia. We have taken several significant steps that include ongoing consultation with a state-appointed consultant, a partnership with an academic psychiatry department that espoused the recovery philosophy, transformation of medication-focused treatment teams into multidisciplinary recovery teams and proliferation of evidence-based rehabilitative interventions as a platform for medication management. The Medical College of Georgia Department of Psychiatry and Health Behavior had created the Georgia Recovery-based Educational Approach to Treatment (Project). In the context of its partnership with state psychiatric hospital, the Department of Psychiatry and Health Behavior made its recovery-based training curriculum available to the state hospital's clinical and support staff. As evident in our own experience, recovery-based systems transformation is fraught with challenges, but it also offers clinicians and clinical administrators useful guidelines for successful implementation of recovery framework within state psychiatric institutions. [ABSTRACT FROM AUTHOR]

This paper presents research results on the BIH firms' financial reporting quality, utilizing empirical relation between accounting conservatism, generated in created critical accounting policy choices, and management abilities in estimates and prediction power of domicile private sector accounting. Primary research is conducted based on firms' financial statements, constructing CAPCBIH (Critical Accounting Policy Choices relevant in B&H) variable that presents particular internal control system and risk assessment; and that influences financial reporting positions in accordance with specific business environment. I argue that firms' management possesses no relevant capacity to determine risks and true consumption of economic benefits, leading to creation of hidden reserves in inventories and accounts payable; and latent losses for bad debt and assets revaluations. I draw special attention to recent IFRS convergences to US GAAP, especially in harmonizing with FAS 130 Reporting comprehensive income (in revised IAS 1) and FAS 157 Fair value measurement. CAPCBIH variable, resulted in very poor performance, presents considerable lack of recognizing environment specifics. Furthermore, I underline the importance of revised ISAE and re-enforced role of auditors in assessing relevance of management estimates. [ABSTRACT FROM AUTHOR]

We report an outbreak associated with a dinner cruise on Lake Michigan. This took place on the same day as heavy rainfall, which resulted in 42·4 billion liters of rainwater and storm runoff containing highly diluted sewage being released into the lake. Of 72 cruise participants, 41 (57%) reported gastroenteritis. Stool specimens were positive for Shigella sonnei (n=3), Giardia (n=3), and Cryptosporidium (n=2). Ice consumption was associated with illness (risk ratio 2·2, P=0·011). S. sonnei was isolated from a swab obtained from the one of the boat's ice bins. Environmental inspection revealed conditions and equipment that could have contributed to lake water contaminating the hose used to load potable water onto the boat. Knowledge of water holding and distribution systems on boats, and of potential risks associated with flooding and the release of diluted sewage into large bodies of water, is crucial for public health guidance regarding recreational cruises. [ABSTRACT FROM PUBLISHER]

Background: The long-term safety and tolerability of sildenafil treatment of pulmonary arterial hypertension (PAH) were assessed.Methods: Two hundred fifty-nine of 277 randomized and treated patients completed a 12-week, double-blind, placebo-controlled trial (SUPER-1 [Sildenafil Use in Pulmonary Arterial Hypertension]) of oral sildenafil in treatment-naive patients with PAH (96% functional class II/III) and entered an open-label uncontrolled extension study (SUPER-2) that continued until the last patient completed 3 years of sildenafil treatment. Patients titrated to sildenafil 80 mg tid; one dose reduction for tolerability was allowed during the titration phase.Results: The median duration of sildenafil treatment across SUPER-1 and SUPER-2 was 1,242 days (range, 1-1,523 days); 170 patients (61%) completed both studies, and 89 patients discontinued from SUPER-2. After 3 years, 87% of 183 patients on treatment were receiving sildenafil 80 mg tid. Of patients remaining under follow-up, 3%, 10%, and 18% were receiving a second approved PAH therapy at 1, 2, and 3 years, respectively. At 3 years post-SUPER-1 baseline, 127 patients had an increased 6-min walk distance (6MWD); 81 improved and 86 maintained functional class. Most adverse events were of mild or moderate severity. At 3 years, 53 patients had died (censored, n = 37). Three-year estimated survival rate was 79%; if all censored patients were assumed to have died, 3-year survival rate was 68%. No deaths were considered to be treatment related.Conclusions: Long-term treatment of PAH initiated as sildenafil monotherapy was generally well tolerated. After 3 years, the majority of patients (60%) who entered the SUPER-1 trial improved or maintained their functional status, and 46% maintained or improved 6MWD. [ABSTRACT FROM AUTHOR]

The article explores the long-term safety and tolerability of sildenafil treatment of pulmonary arterial hypertension (PAH). Results reveal that, in general, long-term treatment of PAH initiated as sildenafil monotherapy was well tolerated. After three years, 60% of patients who entered the Sildenafil Use in Pulmonary Arterial Hypertension (SUPER)-1 trial improved or maintained their functional status, and 46% kept or improved 6-min walk distance (6MWD).

Objective: Inhaled human insulin (Exubera((R)); EXU) has shown encouraging tolerability in short-term trials. We evaluated the safety profile of EXU after long-term exposure. Design: In two, open-label, 2-year studies patients poorly controlled on a sulphonylurea were randomised to adjunctive EXU or metformin (study 1) and patients poorly controlled on metformin were randomised to adjunctive EXU or the sulphonylurea, glibenclamide (study 2). Patients: The studies included 446 (study 1) and 476 (study 2) patients with type 2 diabetes, no clinically significant respiratory disease and glycosylated haemoglobin (HbA(1c)) levels of 8-12%. Measurements: Main outcome measures were pulmonary function tests and insulin antibody assays. Results: A total of 109 patients (study 1) and 195 patients (study 2) completed 104 weeks treatment. In both studies, small treatment group differences in change from baseline forced expiratory volume in 1 s were greatest at 6 months (first time-point measured) and less at later visits, and reversed on treatment discontinuation. At 2 years, differences in mean changes were -0.10 and -0.01 l in studies 1 and 2, respectively, and -0.04 l for the pooled studies. There was no discernable effect of long-term EXU therapy on pulmonary gas exchange. Insulin antibody binding reached a plateau at 6 months and did not correlate with HbA(1c) or lung function changes. Glycaemic control was maintained over 2 years. Conclusions: Exubera was well tolerated during long-term use. Pulmonary function changes compared with comparator groups were small, non-progressive and reversed upon treatment discontinuation. Importantly, rates of lung function change were indistinguishable between EXU and comparator after 6 months of therapy. [ABSTRACT FROM AUTHOR]

Objective: Inhaled human insulin (Exubera®; EXU) has shown encouraging tolerability in short-term trials. We evaluated the safety profile of EXU after long-term exposure. Design: In two, open-label, 2-year studies patients poorly controlled on a sulphonylurea were randomised to adjunctive EXU or metformin (study 1) and patients poorly controlled on metformin were randomised to adjunctive EXU or the sulphonylurea, glibenclamide (study 2). Patients: The studies included 446 (study 1) and 476 (study 2) patients with type 2 diabetes, no clinically significant respiratory disease and glycosylated haemoglobin (HbA1c) levels of 8–12%. Measurements: Main outcome measures were pulmonary function tests and insulin antibody assays. Results: A total of 109 patients (study 1) and 195 patients (study 2) completed 104 weeks treatment. In both studies, small treatment group differences in change from baseline forced expiratory volume in 1 s were greatest at 6 months (first time-point measured) and less at later visits, and reversed on treatment discontinuation. At 2 years, differences in mean changes were −0.10 and −0.01 l in studies 1 and 2, respectively, and −0.04 l for the pooled studies. There was no discernable effect of long-term EXU therapy on pulmonary gas exchange. Insulin antibody binding reached a plateau at 6 months and did not correlate with HbA1c or lung function changes. Glycaemic control was maintained over 2 years. Conclusions: Exubera was well tolerated during long-term use. Pulmonary function changes compared with comparator groups were small, non-progressive and reversed upon treatment discontinuation. Importantly, rates of lung function change were indistinguishable between EXU and comparator after 6 months of therapy. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To compare the efficacy and safety profile of adding inhaled human insulin (INH) (Exubera) or glibenclamide to metformin monotherapy in patients with poorly controlled type 2 diabetes. RESEARCH DESIGN AND METHODS-- We conducted an open-label, parallel, 24-week multicenter trial. Patients uncontrolled on metformin were randomized to adjunctive [NH (n = 243) or glibenclamide (n = 233). Before randomization, patients were divided into two HbA1c (A1C) arms: ≥8 to ≤9.5% (moderately high) and >9.5 to ≤12% (very high). The primary efficacy end point was A1C change from baseline. RESULTS -- Mean adjusted A1C changes from baseline were -2.03 and - 1.88% in the INH and glibenclamide groups, respectively; between-treatment difference - 0.17% (95 % CI - 0.34 to 0.01; P = 0.058), consistent with the noninferiority criterion. In the A1C >9.5% arm, inhaled insulin demonstrated a significantly greater reduction in A1C than glibenclamide, between-treatment difference -0.37% (-0.62 to -0.12; P = 0.004). In the A1C ≤9.5% arm, between-treatment difference was 0.04% (-0.19 to 0.27; P = 0.733). Hypoglycemia (events per subject-month) was greater with INH (0.18) than glibenclamide (0.08), risk ratio 2.24 (1.58-3.16), but there were no associated discontinuations. Other adverse events, except increased cough in the INH group, were similar. At week 24, changes from baseline in pulmonary function parameters were small. Insulin antibody binding increased more with INH but did not have any associated clinical manifestations. CONCLUSIONS -- In patients with type 2 diabetes poorly controlled on metformin, adding INH or glibenclamide was similarly effective in improving glycemic control, and both were well tolerated. A predefined subgroup with very high A1C (>9.5%) was more effectively treated with the addition of INH. [ABSTRACT FROM AUTHOR]

OBJECTIVE -- To compare the efficacy and safety profile of adding inhaled human insulin (INH; Exubera) or metformin to sulfonylurea monotherapy in patients with poorly controlled type 2 diabetes. RESEARCH DESIGN AND METHODS -- We performed an open-label, parallel, 24-week, multicenter trial. At week -1, patients uncontrolled on sulfonylurea monotherapy were divided into two HbA1c (A1C) arms: ≥8 to ≤9.5% (moderately high) and >9.5 to ≤12% (very high). Patients were randomized to adjunctive premeal INH (n = 225) or metformin (n = 202). The primary efficacy end point was change in A1C from baseline. RESULTS -- In the A1C >9.5% arm, INH demonstrated a significantly greater reduction in A1C than metformin. Mean adjusted changes from baseline were -2.17 and -1.79%, respectively; between-treatment difference was -0.38% (95% CI -0.63 to -0.14, P = 0.002). In the A1C ≤9.5% arm, mean adjusted A1C changes were -1.94 and -1.87%, respectively (-0.07% [-0.33 to 0.19], P = 0.610), consistent with the noninferiority criterion. Hypoglycemia (events/subject-month) was greater in the INH (0.33) than in the metformin (0.15) group (risk ratio 2.16 [95% CI 1.67-2.78]), but there were no associated discontinuations. Other adverse events, except increased cough in the INH group, were similar. At week 24, changes in pulmonary function parameters were small and comparable between groups. Insulin antibody binding increased more with INH but did not have any associated clinical manifestations. CONCLUSIONS -- In patients with type 2 diabetes poorly controlled on a sulfonylurea (A1C >9.5%), the addition of premeal INH significantly improves glycemic control compared with adjunctive metformin and is well tolerated. [ABSTRACT FROM AUTHOR]

Aim: To compare the effects of propiverine and oxybutynin on ambulatory urodynamic monitoring (AUM) parameters, safety, and tolerability in patients with overactive bladder. Methods: This was a randomized, double-blind, placebo-controlled, multicentre, crossover study. Patients ( n = 77) received two of the following treatments during two 2-week periods: propiverine 20 mg once daily, propiverine 15 mg three times daily, oxybutynin 5 mg three times daily, and placebo. AUM parameters, salivary flow, visual near point, and heart rate were assessed. Results: A consistent order in the efficacy between active treatment groups was observed for the reduction in mean involuntary detrusor contractions (IDCs; oxybutynin 15 mg ≤ propiverine 45 mg ≤ propiverine 20 mg). Differences between the oxybutynin and propiverine 20 mg groups were statistically significant for several AUM endpoints. Statistically significant differences between the oxybutynin and both propiverine groups were also noted in salivary flow rate and heart rate (oxybutynin 15 mg < both propiverine regimens) and in heart rate variability (both propiverine regimens < oxybutynin 15 mg). All active treatments lengthened visual near point. The incidence of dry mouth was significantly more pronounced in the oxybutynin group than in either propiverine group. Treatment with propiverine 45 mg resulted in the highest rates of constipation, lengthening of the visual near point, and effects on heart rate. Conclusions: Oxybutynin 15 mg was more effective than propiverine 20 mg in reducing symptomatic and asymptomatic IDCs in ambulatory patients. The primary differences between the two drugs were the incidence and type of adverse events, which varied with the antimuscarinic receptor specificity of each agent. [ABSTRACT FROM AUTHOR]

The purpose of this article is to outline the benefits of an ecological model framework for conducting cross-cultural psychological research with immigrant populations. There are four ways we hope to add to the existing literature. First, we propose an ecological framework to assess the develop mental processes and mental health outcomes for immigrants over time. Second, we present interdisciplinary and international research on immigrants' experiences to further efforts to share knowledge and enhance understanding of the impact of globalization on immigrants' experiences. Third, we describe factors leading to immigrants' positive and negative mental health outcomes. Fourth, we discuss the processes of acculturation and adaptation using an ecological framework. We conclude with recommendations for how scholars may use the ecological model to enhance research on immigrants' acculturation experiences. [ABSTRACT FROM AUTHOR]

Context The superiority of innovative over standard treatments is not known. To describe accurately the outcomes of innovations that are tested in randomized controlled trials (RCTs) 3 factors have to be considered: publication rate, quality of trials, and the choice of the adequate comparator intervention. Objective To determine the success rate of innovative treatments by assessing preferences between experimental and standard treatments according to original investigators' conclusions, determining the proportion of RCTs that achieved primary outcomes' statistical significance, and performing meta-analysis to examine if the summary point estimate favored innovative vs standard treatments. Data Sources Randomized controlled trials conducted by the Radiation Therapy Oncology Group (RTOG). Study Selection All completed phase 3 trials conducted by the RTOG since its creation in 1968 until 2002. For multiple publications of the same study, we used the one with the most complete primary outcomes and with the longest follow-up information. Data Extraction We used the US National Cancer Institute definition of completed studies to determine the publication rate. We extracted data related to publication status, methodological quality, and treatment comparisons. One investigator extracted the data from all studies and 2 independent investigators extracted randomly about 50% of the data. Disagreements were resolved by consensus during a meeting. Data Synthesis Data on 12 734 patients from 57 trials were evaluated. The publication rate was 95%. The quality of trials was high. We found no evidence of inappropriateness of the choice of comparator. Although the investigators judged that standard treatments were preferred in 71% of the comparisons, when data were meta-analyzed innovations were as likely as standard treatments to be successful (odds ratio for survival, 1.01; 99% confidence interval, 0.96-1.07; P = .5). In contrast, treatment-related mortality was worse with inn... [ABSTRACT FROM AUTHOR]

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Because of the lack of non-invasive methods for measuring muscle blood flow, quantitative investigations of blood flow in the skeletal muscle of hypertensive subjects are rare. We therefore developed a new method for the determination of muscle blood flow noninvasively and quantitatively by a combination of computed tomography and venous occlusion plethysmography (strain-gauge method). At two sites on one forearm (p=site of the largest diameter, d=1 cm proximal to the epicondyle lat.) the volumes of tissues [V=total volume, V=muscle volume, V=bone volume, V=residual volume=V−(V+V)] were determined by computed tomograms and total forearm blood flow (F and F, respectively in ml/100 ml tissue x min) measured by strain-gauge plethysmography. After correcting for the bone volume at the different sites, F and F were transformed into the absolute influx rates of blood volume (Q and Q). From Q and Q and the different tissue volumes, the muscle bloof flow (F in ml/100 ml muscle x min) could be calculated: Results thus derived were compared with data from the literature Cooper et al. (17). At rest there was neither a significant difference in F (own results: 3.62±1.67, Cooper: 3.25±1.42 ml/100 ml tissue x min, means±S.D.) nor in F (4.08±2.07 and 3.66±1.57 ml/100 ml muscle x min, respectively), however, F and F were significantly different (p<0.05). In the mean, F was 13% greater than F, range: −40 to +38% (Cooper 15%, range: −17 to +43%). The individual difference could not be predicted by any of the parameters. Testing the procedure by means of a pharmacological agent (clonidine) with known effects on muscle blood flow (no change) and skin blood flow (decrease) revealed the correct reproduction of this hemodynamic pattern with our method. The usual identification of total with muscle blood flow would have led to false conclusions. [ABSTRACT FROM AUTHOR]

32 patients with internal fixation of the spine were postoperatively examined by computerized tomography. Details of metallic osteosynthetic material were demonstrated in all our cases. Bony structures were well defined in 27 patients, whereas soft tissue imaging was degraded by scattering artifacts in 14 of 20 examinations. Application of intrathecal contrast medium, however, was helpful for the evaluation of intraspinal soft tissues. Involvement of extraspinal soft tissues could be interpreted on the basis extent of vertebral osseous destruction. [ABSTRACT FROM AUTHOR]