Demographic and Clinical Donor Characteristics as Predictors of Total Nucleated Cell Concentrations in Harvested Marrow Products.

Successful allogeneic hematopoietic stem cell transplantation (alloHSCT) relies significantly on adequate allograft cell composition to achieve sustained engraftment, and a minimum of 2 × 108 total nucleated cells (TNCs) per kilogram of recipient body weight has been identified as the prerequisite cell dose for successful engraftment of marrow-derived products. To meet this minimum requirement, marrow harvest volumes are estimated based on anticipated TNC concentrations of 18.3 × 106/mL. However, there is considerable variability in marrow TNC concentrations. Thus, an algorithm that incorporates baseline donor characteristics to predict TNC concentrations could optimize outcomes for both donors and recipients. For this study, donor baseline characteristics and corresponding unstimulated marrow products harvested between 2004 and 2017 at a single large-volume donor center were collected. Multivariable analysis was used to identify significant predictors of TNC concentration. Two models-ordinary least squares (OLS) and least absolute shrinkage and selection operator (LASSO) regression-were compared for their fitness to the data and their utility in predicting TNCs. Donors with higher body mass index, younger age, male sex, white race/ethnicity, smaller harvest volumes, lower preharvest hematocrit, higher preharvest platelet count, and higher preharvest WBC count predicted significantly higher TNC concentrations in marrow products. When comparing predictive models that incorporate these characteristics, the cross-validated LASSO and bootstrapped OLS provided the best fit. We now supply these formulas to be validated in other datasets before clinical use. TNC concentration in marrow products can be predicted using donor characteristics, most of which are readily available during the donor clinical assessment. The ability to predict marrow allograft TNC concentrations can optimize collection volumes during a harvest.

Written Informed Consent-Translating into Plain Language. A Pilot Study.

BACKGROUND: Informed consent is important in clinical practice, as a person's written consent is required prior to many medical interventions. Many informed consent forms fail to communicate simply and clearly. The aim of our study was to create an easy-to-understand form. METHODS: Our assessment of a Polish-language plastic surgery informed consent form used the Polish-language comprehension analysis program (jasnopis.pl, SWPS University) to assess the readability of texts written for people of various education levels; and this enabled us to modify the form by shortening sentences and simplifying words. The form was re-assessed with the same software and subsequently given to 160 adult volunteers to assess the revised form's degree of difficulty or readability. RESULTS: The first software analysis found the language was suitable for people with a university degree or higher education, and after revision and re-assessment became suitable for persons with 4-6 years of primary school education and above. Most study participants also assessed the form as completely comprehensible. CONCLUSIONS: There are significant benefits possible for patients and practitioners by improving the comprehensibility of written informed consent forms.

Drug-safety reporting in Polish nursing practice-Cross sectional surveys.

INTRODUCTION: Nurses play a significant role in ensuring the safety and quality of drugs. Our aim was to assess significant factors in nurses' participation in ensuring pharmacotherapy safety by reporting adverse drug reactions (ADR) and detecting substandard drugs (SD). MATERIALS AND METHODS: The study was a cross-sectional, comparative survey, using original questionnaires. Survey questions were grouped to probe the opinions, attitudes and practices of nurses reporting ADRs and SDs. Data were obtained from nurses working in teaching hospitals in Poland (group A) and, for comparison, in the USA (group B). 1200 questionnaires were distributed in Poland (return rate: 55.7%) and 200 questionnaires in the USA (return rate: 73%). Both groups were surveyed during the same period. There were no exclusion criteria. The questionnaires were self-administered. Distribution and collection were anonymous. Participation was voluntary. The Spearman correlation test was used. Both groups' responses were cross-tabulated and compared using Fisher's Exact Test for Count Data. RESULTS: The study group comprised 669 Polish and 146 American professionally active nurses working in general care and surgical departments. Age range: 18 to 72 years. Median job seniority: 18.3 years (group A) and 20.6 years (group B). Education levels varied. ADR reporting conditions in Poland are unfavorable: shortage of time-83.9% vs 22.6% in the US (p = 0.01); no incentive-58.2% vs 6.1% in the US (p = 0.01); and no equipment-44.7% vs 2.8% in the US (p < 0.01). Both Polish and American nurses indicate they rarely report SDs, with rates of 0.4% and 11% (p < 0.0001) respectively, during the study period. CONCLUSIONS: Nurses in Poland are insufficiently prepared to ensure drug safety conscientiously and responsibly. Training is required for Polish nurses. Nurses' employers need to improve conditions to enable reporting of ADRs and SDs.

Current Regulation of Mobile Mental Health Applications.

In recent years, the availability of software that is targeted toward the general public and designed to assist in the diagnosis and treatment of mental illness or to promote general mental health has expanded greatly. Regulation of more traditional health care providers and health care-associated devices is well established by statute, regulatory guidelines, and common law precedents. Applications (apps), in contrast, pose a novel regulatory challenge. This review examines the current regulatory guidelines for psychiatric mobile mental health apps, as well as the current state of case law in the psychiatric mobile mental health realm.

St. George's Respiratory Questionnaire has longitudinal construct validity in lymphangioleiomyomatosis.

BACKGROUND: Lymphangioleiomyomatosis (LAM) is an uncommon, progressive, cystic lung disease that causes shortness of breath, hypoxemia, and impaired health-related quality of life (HRQL). Whether St. George's Respiratory Questionnaire (SGRQ), a respiratory-specific HRQL instrument, captures longitudinal changes in HRQL in patients with LAM is unknown. METHODS: Using data from the Multicenter International Lymphangioleiomyomatosis Efficacy and Safety of Sirolimus trial, we performed analyses to examine associations between SGRQ scores and values for four external measures (anchors). Anchors included (1) FEV1, (2) diffusing capacity of the lung for carbon monoxide, (3) distance walked during the 6-min walk test, and (4) serum vascular endothelial growth factor-D. RESULTS: SGRQ scores correlated with the majority of anchor values at baseline, 6 months, and 12 months. Results from longitudinal analyses demonstrated that SGRQ change scores tracked changes over time in values for each of the four anchors. At 12 months, subjects with the greatest improvement from baseline in FEV1 experienced the greatest improvement in SGRQ scores (Symptoms domain, -13.4 ± 14.6 points; Activity domain, -6.46 ± 8.20 points; Impacts domain, -6.25 ± 12.8 points; SGRQ total, -7.53 ± 10.0 points). Plots of cumulative distribution functions further supported the longitudinal validity of the SGRQ in LAM. CONCLUSIONS: In LAM, SGRQ scores are associated with variables used to assess LAM severity. The SGRQ is sensitive to change in LAM severity, particularly when change is defined by FEV1, perhaps the most clinically relevant and prognostically important variable in LAM. The constellation of results here supports the validity of the SGRQ as capable of assessing longitudinal change in HRQL in LAM.

Factors associated with the sexual assault of students: an exploratory study of victims treated at hospital-based sexual assault treatment centers.

Research suggests that students experience high levels of sexual assault, but studies addressing how they differ in their experiences from other sexual assault victims are virtually nonexistent. To address this gap, information was collected from consecutive individuals, aged 16 years or older, presenting to one of 7 hospital-based sexual assault treatment centers in Ontario from 2005 to 2007. Of the 882 victims seen during the study period, 32% were students. Relative to other sexual assault victims, students were more likely to be aged 16 to 18 years and 19 to 24 years versus 25 years and older. They were more likely to be living alone, with family of origin, a partner or spouse, or a nonrelative than on the street or in a shelter or institution. They were also more likely to report having consumed over-the-counter medication in the 72 hours prior to examination. Student victims were less likely than nonstudent victims to report having a disability and having used street drugs. Implications for research, education, and practice are discussed.

Efficacy and safety of sirolimus in lymphangioleiomyomatosis.

BACKGROUND: Lymphangioleiomyomatosis (LAM) is a progressive, cystic lung disease in women; it is associated with inappropriate activation of mammalian target of rapamycin (mTOR) signaling, which regulates cellular growth and lymphangiogenesis. Sirolimus (also called rapamycin) inhibits mTOR and has shown promise in phase 1-2 trials involving patients with LAM. METHODS: We conducted a two-stage trial of sirolimus involving 89 patients with LAM who had moderate lung impairment--a 12-month randomized, double-blind comparison of sirolimus with placebo, followed by a 12-month observation period. The primary end point was the difference between the groups in the rate of change (slope) in forced expiratory volume in 1 second (FEV(1)). RESULTS: During the treatment period, the FEV(1) slope was -12±2 ml per month in the placebo group (43 patients) and 1±2 ml per month in the sirolimus group (46 patients) (P<0.001). The absolute between-group difference in the mean change in FEV(1) during the treatment period was 153 ml, or approximately 11% of the mean FEV(1) at enrollment. As compared with the placebo group, the sirolimus group had improvement from baseline to 12 months in measures of forced vital capacity, functional residual capacity, serum vascular endothelial growth factor D (VEGF-D), and quality of life and functional performance. There was no significant between-group difference in this interval in the change in 6-minute walk distance or diffusing capacity of the lung for carbon monoxide. After discontinuation of sirolimus, the decline in lung function resumed in the sirolimus group and paralleled that in the placebo group. Adverse events were more common with sirolimus, but the frequency of serious adverse events did not differ significantly between the groups. CONCLUSIONS: In patients with LAM, sirolimus stabilized lung function, reduced serum VEGF-D levels, and was associated with a reduction in symptoms and improvement in quality of life. Therapy with sirolimus may be useful in selected patients with LAM. (Funded by the National Institutes of Health and others; MILES ClinicalTrials.gov number, NCT00414648.).

Rates of depression and anxiety in urban and rural Canada.

BACKGROUND: Studies of urban-rural differences in rates of non-psychotic psychiatric disorders have produced contradictory results, with some finding higher urban rates and others no difference. AIMS: This study aimed to compare geographic variability of rates of depression and three anxiety disorders in a large, random community sample of Canadian residents. METHOD: Data from the 2002 Canadian Community Health Survey 1.2 were analyzed, using a four-category classification of urban-rurality. RESULTS: Significant bivariate urban-rural differences were found for age, marital status, country of birth, ethnicity, education, household income, income adequacy, employment, home ownership, physical activity, perceived stress, and physical health. In addition, participants in the urban core and urban fringe had a weaker sense of belonging to their community and reported lower social support. There was a modest urban excess of depression in the previous 12 months but no difference in rates of agoraphobia, panic disorder or social phobia across the geographical areas. The multivariate modeling showed a lower prevalence of depression for people living in the most rural environment only (odds ratio = 0.76, 95% confidence interval = 0.59, 0.98). Factors associated with an increased rate of depression in the model were female gender, younger age, being not married, being born in Canada, white ethnicity, higher education, unemployment, not owning one's home, and poor physical health. Also, participants with a stronger sense of belonging to their community and higher social support reported lower rates of depression. CONCLUSIONS: These results confirmed a lower risk of depression amongst rural dwellers, which was associated with a stronger sense of community belonging. Further research on this topic could usefully include community-level variables, usually subsumed under the rubric of social capital.

Drug-facilitated sexual assault in Ontario, Canada: toxicological and DNA findings.

The purpose of this study was to determine which persons reporting sexual assault to a hospital-based treatment centre may have been covertly drugged and to provide information about whether a sexual assault may have occurred. Each consecutive adolescent and adult presenting at a sexual assault treatment centre was screened for drug-facilitated sexual assault (DFSA). Urine was collected and tested for central nervous system active drugs. Oral, vaginal, and/or rectal swabs were tested for male DNA. Unexpected drugs were defined as those not reported as having been voluntarily consumed within the previous 72 h. Positive swabs for unexpected DNA were determined by whether the person reported having had consensual intercourse in the previous week. A total of 184 of 882 eligible participants met suspected DFSA criteria. Mean age was 25.8 years (SD=8.5), 96.2% were female and 64.7% White. Urine samples were positive for drugs in 44.9% of cases, alcohol in 12.9%, and both drugs and alcohol in 18.0%. The drugs found on toxicological screening were unexpected in 87 of the 135 (64.4%) cases with a positive drug finding and included cannabinoids (40.2%), cocaine (32.2%), amphetamines (13.8%), MDMA (9.2%), ketamine (2.3%), and GHB (1.1%). Male DNA was unexpected in 30 (46.9%) of 64 cases where it was found. Among those persons presenting to a sexual assault treatment centre with a suspicion of DFSA, the presence of unexpected drugs and male DNA was common, lending support for their contention that they had been intentionally drugged and sexually assaulted. Most unexpected drugs found were not those typically described as 'date rape drugs'.

Factors associated with child witnessing of intimate partner violence in Canada.

Knowing the characteristics associated with child exposure to spousal abuse could aid in early identification of at-risk children. The purpose of our study is to determine possible factors associated with child witnessing of intimate partner violence (IPV) in Canada using data from the 1999 General Social Survey, a representative telephone survey of Canadians aged 15 years and older. Respondents reporting IPV in the five years prior to the survey were asked whether a child had witnessed the incident. Multivariate logistic regression was used to determine the association between child witnessing of IPV and victim, assault, and help-seeking characteristics. Households in which child witnessing of IPV was reported were distinguished by the following factors: female respondent, visible minority, over age 30, separated, divorced, or widowed, low income, and the presence of children aged 0-14 years. Other significant variables associated with child witnessing of IPV were related to the frequency, reporting, and disclosure of violent incidents.

Factors associated with suspected drug-facilitated sexual assault.

BACKGROUND: There has been little systematic investigation of widespread reports of drugging and sexual assault. We sought to determine the prevalence of and factors associated with suspected drug-facilitated sexual assault. METHODS: Between June 2005 and March 2007, a total of 977 consecutive sexual assault victims underwent screening for suspected drugging at 7 hospital-based sexual assault treatment centres. We defined victims of drug-facilitated sexual assault as those who presented to a centre within about 72 hours of being assaulted and who provided at least 1 valid reason for suspecting that she or he had been drugged and sexually assaulted. We used logistic regression modelling to compare victims of suspected drug-facilitated sexual assault with other sexual assault victims, controlling for covariates. RESULTS: In total, 882 victims were eligible for inclusion in the study. Of these, 855 (96.9%) were women, and 184 (20.9%) met the criteria for suspected drug-facilitated sexual assault. Compared with other victims, victims of drug-facilitated sexual assault were more likely to have presented to a large urban centre for care (odds ratio [OR] 2.31, 95% confidence interval [CI] 1.47-3.65), to be employed (OR 1.92, 95% CI 1.34-2.76), to have consumed over-the-counter medications (OR 3.97, 95% CI 2.47-6.38) and street drugs (OR 1.71, 95% CI 1.12-2.62) in the 72 hours before being examined and to have used alcohol before the assault (OR 4.00, 95% CI 2.53-6.32). INTERPRETATION: Suspected drug-facilitated sexual assault is a common problem. Sexual assault services should be tailored to meet the needs of those experiencing this type of victimization.

Help-seeking behavior for intimate partner violence among racial minority women in Canada.

INTRODUCTION: Intimate partner violence (IPV) is experienced by women of all ethnoracial backgrounds. Despite the serious adverse impacts of IPV on women's lives, many abused women do not seek help. The main objective of this paper was to determine whether a woman's racial minority status was a significant predictor of help-seeking for IPV after controlling for other factors associated with help-seeking. METHODS: Data from a national Canadian, cross-sectional, telephone survey were used. Help-seeking variables included disclosure of IPV, reporting IPV to police, the use of social services subsequent to IPV, and barriers to social service use. RESULTS: In the bivariate analyses, rates of disclosure and reporting to police were similar for racial minority and white women, however, racial minority women, compared to white women, were significantly less likely to use social services. After adjustment for age, marital status, household income, number of young children at home, immigration status, household language, and severity of IPV, racial minority status was not a significant predictor of help-seeking in the multivariate analysis. DISCUSSION: Our findings suggest that further investigation is necessary to understand what aspects of membership in a racial minority group or sytemic factors may be contributing to inequalities in accessing help for IPV.

The association between role overload and women's mental health.

OBJECTIVE: To determine the importance of role overload (the extent to which a person feels overwhelmed by her total responsibilities) relative to other known social determinants of women's mental health. METHODS: A Canadian national, random sample, cross-sectional telephone survey in 2003 assessed the association among role overload, types and quality of roles (parent, employee, spouse), sociodemographics, and mental health (using the SF-12) using linear regression. Analysis included 716 women aged 25-54 who indicated that their youngest child living in the household was aged < or =17 years. RESULTS: Perceptions of greater role overload were associated with poorer mental health (p < 0.0001). Women working <35 hours per week (p = 0.04) or 35-40 hours per week (p 5 0.002) reported better mental health than nonemployed women, as did women with the highest annual household income ($70,000+)(p = 0.001). Also associated with better mental health were higher marital status quality scores for both married and single women (p < 0.001), higher job quality scores among employed women (p = 0.02), greater homemaking quality scores among unemployed women (p = 0.03), and women reporting high parental quality (p = 0.04) CONCLUSIONS: Role overload showed a stronger relationship to mental health than other sociodemographic variables, including income. Our findings indicate the importance of measuring women's experience of their multiple roles rather than focusing on single roles. More research is warranted on the totality of women's experiences of their many social role obligations.

Pregnancy experiences among women with lymphangioleiomyomatosis.

Lymphangioleiomyomatosis (LAM) is a rare lung disease affecting women. Following case reports that pregnancy exacerbates LAM, patients are frequently advised to avoid pregnancy. Our objective was to determine pregnancy and health outcomes in LAM to provide better evidence with which to council patients contemplating pregnancy. We surveyed 328 women with LAM regarding pregnancy outcomes, pulmonary function, subjective and psychological functioning, quality of life, dyspnoea and fatigue. Amongst childless women the main reason not to attempt pregnancy was based on concerns about potential effects of pregnancy on LAM. Almost two thirds of patients had been pregnant, the majority before LAM was diagnosed, in whom pregnancy outcome was generally favourable. Women diagnosed with LAM (n=15) during pregnancy had high rates of pneumothorax (67%), miscarriage (7%) and premature birth (47%). The group diagnosed with LAM before or during pregnancy (n=12) had lower mean FEV(1), FVC and DLCO after pregnancy compared with those diagnosed following pregnancy or never pregnant. There were no differences in subjective or psychological functioning, quality of life, dyspnoea or fatigue scores between groups. In newly diagnosed LAM patients there was a high incidence of premature birth and pneumothorax. These adverse outcomes may be a marker of aggressive LAM.

Gender and psychotropic medication use: the role of intimate partner violence.

OBJECTIVE: Women are known to use more psychotropic medications than men which may be linked to women's greater exposure to intimate partner violence (IPV). METHOD: The use of medications for sleep, depression and anxiety in adults in the 1999 Canadian General Social Survey was assessed. Rates of medication use by adults exposed to IPV (physical, sexual, emotional and financial) were compared to rates of those reporting no IPV. RESULTS: More women (14.9%) than men (9.6%) reported use of psychotropic medications in the preceding month. Rates were significantly higher in both women and men who reported IPV. This link was still present after key sociodemographic and health predictors of medication use were held constant. CONCLUSION: This random population based study provides the first data to support the idea that IPV may explain at least some of the increased psychotropic medication use by women. IPV should be included as a predictor variable in future studies investigating psychotropic medication use which itself can be added to the list of adverse health risks of IPV.

Unexplained and underpowered: the relationship between psychosomatic disorders and interpersonal abuse -- a critical review.

Although it is commonly accepted that interpersonal violence (IntPV) leads to adverse health consequences, the available data are far from decisive. To test the hypothesized link, the authors devised an evidence-based strategy to determine the data quality in studies purporting to link IntPV and some medically unexplained disorders in women (irritable bowel syndrome, chronic pelvic pain, fibromyalgia/chronic fatigue, and other chronic pain syndromes). English language studies with control groups of unaffected women were assessed for the quality of their methodologies. The number of studies, together with the consistency of their findings in each domain, was collated to determine the overall weight of evidence regarding the link for each condition. The quantity and quality of research in each clinical area proved to be sparse. In general, most research was limited to small, convenience samples, with insufficient attention to the design of control groups and to sample size. The evidence currently available regarding irritable bowel syndrome, fibromyalgia/chronic fatigue, chronic pelvic pain, and other chronic pain syndromes does not allow for any firm conclusion regarding their link to IntPV. More research - paying particular regard to the methodological concerns identified here - is required in order to generate any definitive conclusions.

Gender differences in the symptoms of major depressive disorder.

Data from the Canadian Community Health Survey 1.2 were used for a gender analysis of individual symptoms and overall rates of depression in the preceding 12 months. Major depressive disorder was assessed using the Composite International Diagnostic Interview in this national, cross-sectional survey. The female to male ratio of major depressive disorder prevalence was 1.64:1, with n = 1766 having experienced depression (men 668, women 1098). Women reported statistically more depressive symptoms than men (p < 0.001). Depressed women were more likely to report "increased appetite" (15.5% vs. 10.7%), being "often in tears" (82.6% vs. 44.0%), "loss of interest" (86.9% vs. 81.1%), and "thoughts of death" (70.3% vs. 63.4%). No significant gender differences were found for the remaining symptoms. The data are interpreted against women's greater tendency to cry and to restrict food intake when not depressed. The question is raised whether these items preferentially bias assessment of gender differences in depression, particularly in nonclinic samples.

Who is most at risk for intimate partner violence? A Canadian population-based study.

Whole population studies on intimate partner violence (IPV) have given contradictory information about prevalence and risk factors, especially concerning gender. The authors examined the 1999 Canadian General Social Survey data for gender patterns of physical, sexual, emotional, or financial IPV from a current or ex-partner. More women (8.6%) than men (7.0%, p = .001) reported partner physical abuse in general, physical IPV causing physical injury (p < .0001), sexual abuse (1.7% vs. 0.2%, p < .0001), and financial abuse (4.1% vs. 1.6%, p < .0001). There were no gender differences for partner emotional abuse. Significant risk factors after multivariate modeling for physical/sexual IPV were younger age, being divorced/separated or single, having children in the household, and poor self-rated physical health. These findings from a large, randomly generated data set further refine our understanding of the risk profile for IPV in the developed world.