Polydextrose and soluble corn fiber increase five-day fecal wet weight in healthy men and women.

Dietary fiber has well-established beneficial effects on laxation. Many fibers have been developed with positive sensory properties and 2 such fibers are polydextrose (PDX) and soluble corn fiber (SCF), which can be added to many commercially produced products. We conducted a randomized, double-blind, placebo-controlled, crossover study comparing the laxative effects of PDX and SCF at a dose of 20 g/d with a low fiber control (LFC) eaten daily as a muffin and cereal in 36 healthy men and women. Each treatment period was 10 d with a 2-wk washout period between. Participants collected fecal samples during the last 5 d of each treatment and completed food diaries and gastrointestinal tolerance questionnaires on d 1, 2, and 10 of each treatment period. Five-day fecal wet weight was higher after the PDX and SCF treatments than the LFC treatment (P ≤ 0.0007). The number of stools per day and daily fecal output also were significantly greater during the PDX treatment compared with the LFC treatment. The whole gut transit time did not differ among treatments. The PDX treatment resulted in a softer stool (P = 0.002) than the SCF and LFC treatments. Fecal pH was lowered by the PDX treatment (P = 0.02), whereas SCF tended to lower it compared with the LFC treatment (P = 0.07). When the participants consumed PDX and SCF, they reported significantly more flatulence and borborygmi compared with when they consumed the LFC. Consumption of PDX and SCF at a dose of 20 g/d results in a mild laxative effect with nominal gastrointestinal tolerance issues.

Best Practices for Microbial Challenge In-use Studies to Evaluate the Microbial Growth Potential of Parenteral Biological Products; Industry and Regulatory Considerations.

Microbial challenge in-use studies are performed to evaluate the potential for microbial proliferation in preservative-free single dose biological products after first puncture and potential accidental contamination during dose preparation (e.g. reconstitution, dilution) and storage. These studies, in addition to physicochemical in-use stability assessments, are used as part of product registration to define in-use hold times in Prescribing Information and in the pharmacy manual in the case of clinical products. There are no formal guidance documents describing regulator expectations on how to conduct microbial challenge in-use studies and interpret microbial data to assign in-use storage hold-times. In lieu of guidance, US Food and Drug Administration (FDA) regulators have authored publications and presentations describing regulator expectations. Insufficient or unavailable microbial challenge data can result in shortened in-use hold times, thus microbial challenge data enables flexibility for health care providers (HCPs) and patients, while ensuring patient safety. A cross-industry/FDA in-use microbial working group was formed through the Innovation & Quality (IQ) Consortium to gain alignment among industry practice and regulator expectations. The working group assessed regulatory guidance, current industry practice via a blinded survey of IQ Consortium member companies, and scientific rationale to align on recommendations for experimental design, execution of microbial challenge in-use studies, and a decision tree for microbial data interpretation to assign in-use hold times. Besides the study execution and data interpretation, additional considerations are discussed including use of platform data for clinical stage products, closed system transfer devices (CSTDs), transport of dose solutions, long infusion times, and the use of USP <797> by HCPs for preparing sterile drugs for administration. The recommendations provided in this manuscript will help streamline biological product development, ensure consistency on assignment of in-use hold times in biological product labels across industry, and provide maximum allowable flexibility to HCPs and patients, while ensuring patient safety.

Comparison of midwife-led and consultant-led care of healthy women at low risk of childbirth complications in the Republic of Ireland: a randomised trial.

BACKGROUND: No midwifery-led units existed in Ireland before 2004. The aim of this study was to compare midwife-led (MLU) versus consultant-led (CLU) care for healthy, pregnant women without risk factors for labour and delivery. METHODS: An unblinded, pragmatic randomised trial was designed, funded by the Health Service Executive (Dublin North-East). Following ethical approval, all women booking prior to 24 weeks of pregnancy at two maternity hospitals with 1,300-3,200 births annually in Ireland were assessed for trial eligibility.1,653 consenting women were centrally randomised on a 2:1 ratio to MLU or CLU care, (1101:552). 'Intention-to-treat' analysis was used to compare 9 key neonatal and maternal outcomes. RESULTS: No statistically significant difference was found between MLU and CLU in the seven key outcomes: caesarean birth (163 [14.8%] vs 84 [15.2%]; relative risk (RR) 0.97 [95% CI 0.76 to 1.24]), induction (248 [22.5%] vs 138 [25.0%]; RR 0.90 [0.75 to 1.08]), episiotomy (126 [11.4%] vs 68 [12.3%]; RR 0.93 [0.70 to 1.23]), instrumental birth (139 [12.6%] vs 79 [14.3%]; RR 0.88 [0.68 to 1.14]), Apgar scores < 8 (10 [0.9%] vs 9 [1.6%]; RR 0.56 [0.23 to 1.36]), postpartum haemorrhage (144 [13.1%] vs 75 [13.6%]; RR 0.96 [0.74 to 1.25]); breastfeeding initiation (616 [55.9%] vs 317 [57.4%]; RR 0.97 [0.89 to 1.06]). MLU women were significantly less likely to have continuous electronic fetal monitoring (397 [36.1%] vs 313 [56.7%]; RR 0.64 [0.57 to 0.71]), or augmentation of labour (436 [39.6%] vs 314 [56.9%]; RR 0.50 [0.40 to 0.61]). CONCLUSIONS: Midwife-led care, as practised in this study, is as safe as consultant-led care and is associated with less intervention during labour and delivery.

Attitudes of psychiatric nurses towards aggression: A polish study.

WHAT IS KNOWN ABOUT THE SUBJECT? (SCIENTIFIC RATIONALE): Mental health care in Poland lags behind that of many other countries, and coercive measures are used on a regular basis. Scant research has been conducted in Poland regarding the treatment of psychiatric patients. The perspectives of Polish psychiatric nurses towards aggression remain unknown. WHAT DOES THIS PAPER ADD TO THE EXISTING KNOWLEDGE?: The translated and validated Attitude Towards Aggression Scale (ATAS) in Polish will serve as an instrument that gauges Polish nurses' attitudes towards aggression. The Polish nurses have unenlightened and negative attitude towards aggression. WHAT ARE THE IMPLICATIONS FOR PRACTICE?: There is now an instrument in Polish by which we can gauge the attitudes of mental health nurses, which must precede any educational efforts. Polish nurses showed more restrictive and antiquated attitudes about patient violence than nurses in some other parts of the world. With a shift to more positive attitudes, the use of coercion could be reduced, resulting in improved patient care. INTRODUCTION: In Poland, the mode and site of patient treatment have changed little in the past 75 years, despite therapeutic advances worldwide. There is limited information regarding attitudes of nurses towards aggression in psychiatric settings in Poland, nor has there been an instrument in Polish to measure it. AIM: To translate and validate the Attitudes Towards Aggression Scale (ATAS) for use in Poland, and to assess the attitudes of three groups of nursing personnel towards aggression. METHOD: We surveyed 980 psychiatric and general nurses as well as nursing students. We translated the ATAS into Polish, and validated it using exploratory factor analysis. RESULTS: The Polish version of the ATAS showed good psychometric properties. We found that Polish nurses perceived patient aggression extremely negatively. DISCUSSION: Polish nurses perceive aggression as destructive, negative and not to be tolerated, leading to use of restraints. Among the three groups, psychiatric nurses showed the most negative attitude towards aggression. Thus, education is needed for preservice and inservice nurses alike to address this issue. WHAT THIS STUDY ADDS TO EXISTING EVIDENCE: We now have a validated instrument to assess nurses' attitudes about aggression. We also know that Polish nurses have exceedingly negative attitudes towards aggression. IMPLICATIONS FOR PRACTICE: The Polish version of ATAS was found valid and reliable. Therefore, we can now measure the attitudes of Polish nurses towards aggression, which was not possible previously. The baseline data provide a starting point from which to determine effects of educational efforts.

Perceptions of Fear, Likelihood of Victimization, and Confidence About Dangerous Situations Among University Women in Poland.

Polish women have not been studied in regard to fear, likelihood, or confidence about dangerous situations, nor has there been an instrument to measure those perceptions. The purpose of the study was fourfold: first, to present the Polish translation and validation of the Perception of Dangerous Situations Scale (PDSS-P) and second, to assess Polish women's perceived fear, likelihood, and confidence about dangerous situations using the PDSS-P (41 items). The third purpose was to determine to what degree the General Self-Efficacy Scale (GSES) and/or the Hope for Success Scale (KNS) correlated with any of the three subscales of the PDSS-P. The fourth purpose was to determine the congruence of the PDSS-P to the original PDSS. Two other tools (GSES and KNS) were administered to determine concurrent validity with the PDSS. A sample of 208 women aged 19 to 27 years (M = 21.04, SD = 1.88) participated in the study. Five factors were determined for each subscale, similar to the original version of the PDSS. Women reported they were more afraid of being raped by a stranger than being murdered. Their estimation of the likelihood of some serious events occurring was not congruent with statistical realities. The women thought the least likely events to happen to them in the next year would be being raped or beaten by someone they know, or being held prisoner by someone who wanted to murder them. Confidence to manage dangerous situations was low in cases of being raped by strangers or known people, being kidnapped, or being attacked. The GSES and KNS provided useful information, in that they did not measure the same constructs as the PDSS-P.

Reducing aggression in psychiatric wards using Safewards-A Polish study.

PURPOSE: To reduce the use of mechanical restraints, Safewards was introduced to a ward in a psychiatric hospital in Poland. DESIGN AND METHODS: Three aspects of Safewards were applied for 8 months. The comparison time period was the same time frame of the previous year. FINDINGS: Restraint use dropped by 24%, and the number of patients restrained dropped 34%. The duration of restraint remained at 2.8 days per episode. PRACTICE IMPLICATIONS: Simple techniques aimed at promoting positive interactions between staff and patients can reduce the frequency of restraints.

The Gender-Related Impact of a Violence Management Training Program on Medical School Students-Preliminary Results.

Phenomenon: Patient aggression directed toward medical personnel, including medical school students during their internships, is an increasingly important issue. To minimize this phenomenon, violence management training programs were carried out. Approach: To assess the efficacy of a violence management training program among medical school students and evaluate changes in the perception of aggressive behavior in relation to the participants' sense of self-efficacy and self-confidence by sex. A quasi-experimental examination of medical school students was performed before and after completion of a training program. Two hundred seventy-six students, including students of medicine, nursing, emergency medical services, and physiotherapy, participated in the study. Three standardized questionnaires were used: The Perception of Aggression Scale (POAS), the Hope for Success Questionnaire (HSQ), and the General Self -Efficacy Scale (GSES). Findings: The training program had a positive impact on the sense of self-efficacy in both men and women. However, the perception of aggressive behavior changed only in women and the impact of such intervention was higher for women. Further studies should look at the long-term outcomes.

Weather and Aggressive Behavior among Patients in Psychiatric Hospitals-An Exploratory Study.

Background: The number of meteoropaths, or people negatively affected by weather conditions, is rising dramatically. Meteoropathy is developing rapidly due to ever poorer adaptations of people to changes in weather conditions. Strong weather stimuli may not only exacerbate symptoms in people with diseases of the cardiovascular and respiratory systems but may also induce aggressive behavior. Researchers have shown that patients suffering from mental illnesses are most vulnerable to changes in the weather and postulate a connection between the seasons and aggressive behavior. Methods: The goal of the study was to analyze the relationship between coercive measures and weather factors. The researchers identified what meteorological conditions prevailed on days with an increased number of incidents of aggressive behavior leading to the use of physical coercion towards patients in a psychiatric hospital in Poland. In order to determine the impact of weather conditions on the frequency at which physical coercion measures were used, the hospital's "coercion sheets" from 1 January 2015 to 31 March 2017 were analyzed. The data were correlated with meteorological data. In order to determine the relationship between the occurrence of specific weather conditions and the number of coercive interventions (N), researchers utilized Spearman's rank correlation analysis together with two-dimensional scatter diagrams (dependency models), multiple regression, stepwise regression, frequencies, and conditional probability (%). Results: Lower barometric pressure and foehn wind increased aggressive behavior in patients that led to coercive measures. For temperature (positive correlation) and humidity (negative correlation), there was a poor but statistically significant correlation. Conclusions: Monitoring weather conditions might be useful in predicting and preventing aggression by patients who are susceptible to weather changes.

Psychological vulnerability in children next-born after stillbirth: a case-control follow-up study.

BACKGROUND: Case studies and anecdotal accounts suggest that perinatal loss may impact upon other children in the family, including those born subsequent to loss. However, there is a dearth of systematically collected quantitative data on this potentially vulnerable group. METHODS: Case-controlled follow-up of 52 mothers with history of stillbirth with their next-born children aged 6-8 years, and 51 control mother-child dyads. Previously reported baseline data included maternal antenatal and postnatal psychological assessment, and infant security of attachment at 12 months. Follow-up assessments included maternal psychiatric and socio-demographic data, mother and teacher-rated scales of the child's strengths and difficulties, child IQ, observer-rated mother-child interaction and maternal reports of child health. RESULTS: There were no significant between-group differences in child cognitive or health assessments, or in teacher-rated child difficulties. However, mothers with history of stillbirth (the index group) reported increased child difficulties, in particular peer problems, and more adverse interaction was observed in respect of higher levels of maternal criticism of the child's actions, more overall controlling behaviour by the mother, a less harmonious emotional atmosphere and a lower level of maternal engagement with the child. Some of these effects appeared to be mediated by maternal perinatal psychological symptoms and family breakdown. CONCLUSIONS: This study provides no evidence to suggest that siblings born after stillbirth are clinically at risk but does lend empirical support to clinical reports that such children are seen by their mothers as having problems and that they are exposed to less optimal interaction with their mothers. Possible interpretations of these findings are discussed in the context of theoretical accounts of 'replacement child' and 'vulnerable child' syndromes.

Risky sexual behavior, bleeding caused by intimate partner violence, and hepatitis C virus infection in patients of a sexually transmitted disease clinic.

OBJECTIVES: We sought to investigate independent contributions of risky sexual behaviors and bleeding caused by intimate partner violence to prediction of HCV infection. METHODS: We conducted a case-control study of risk factors among patients of a sexually transmitted disease clinic with and without HCV antibodies, group-matched by age. RESULTS: Multivariate analyses indicated that Black race (odds ratio [OR] = 2.4; 95% confidence interval [CI] = 1.3, 4.4), injection drug use (OR = 20.3; 95% CI = 10.8, 37.8), sharing straws to snort drugs (OR = 1.8; 95% CI = 1.01, 3.0), sharing razors (OR = 7.8; 95% CI = 2.0, 31.0), and exposure to bleeding caused by intimate partner violence (OR = 5.5; 95% CI = 1.4, 22.8) contributed significantly to the prediction of HCV infection; risky sexual behavior and exposure to blood or sores during sexual intercourse did not. CONCLUSIONS: HCV risk among patients of a sexually transmitted disease clinic can be explained by direct blood exposure, primarily through injection drug use. Exposure to bleeding caused by intimate partner violence may be a previously unrecognized mechanism for HCV transmission associated with risky sexual behavior.

Long-term psychosocial sequelae of stillbirth: phase II of a nested case-control cohort study.

Stillbirth is associated with increased psychological morbidity in the subsequent pregnancy and puerperium. This study aimed to assess longer-term psychological and social outcomes of stillbirth and to identify factors associated with adverse outcome. We conducted seven-year follow-up of a cohort of women who were initially assessed during and after a pregnancy subsequent to stillbirth, together with pair-matched controls. All women were living with a partner at baseline and none had live children. Measured outcomes at follow-up included depression, posttraumatic stress disorder (PTSD) and partnership breakdown. Comparison variables included social and psychological factors and, for the stillbirth group, factors relating to the lost pregnancy. There were no differences between groups in case level psychological morbidity, but significantly higher levels of PTSD symptoms persisted in stillbirth group mothers who had case level PTSD 7 years earlier. Stillbirth group mothers were more likely to have experienced subsequent partnership breakdown. In the stillbirth group such breakdown was associated with having held the stillborn infant and having had case-level PTSD. Interpretations and clinical implications of these findings are discussed.

A 13-week dietary toxicity study in rats of a Napin-Rich Canola Protein Isolate.

The objective was to study the safety of a Napin-Rich Canola Protein Isolate (NRCPI) fed to rats at various levels for 13-weeks. The study included four groups (20 animals/sex/group) of young Sprague Dawley rats. They were fed ad libitum with an AIN-93G based protein-free diet containing, respectively, 5%, 10% and 20% (w/w) NRCPI (test article) or 20% (w/w) vitamin-free casein (control article). Protein levels were adjusted at 18% in all groups with vitamin-free casein. Body weights, food consumption, locomotor activity and behavioral and clinical pathology parameters were recorded at various points in the study, followed by macroscopic examination, determination of organ weights and microscopic examination at termination. There were no test article-related effects on ophthalmology, functional observations, hematology, serum chemistry, urinalysis, organ weights and macroscopic or microscopic findings. Lower body weight gains were observed in the 10% NRCPI-treated males and the 20% NRCPI-treated males and females. The lower body weight gains were associated with significantly lower food consumption. Therefore, for NRCPI the No Observed Adversed Effect Level (NOAEL) was considered to be 20% (the highest fed level); equivalent to 12.46 g/kg BW/day for males and 14.95 g/kg BW/day for females. The NRCPI was considered safe under the tested conditions.

Psychological aspects of perinatal loss.

After perinatal loss, parents experience painful grief. Fathers and mothers show the same pattern of symptoms, but generally mothers' distress is more intense. Grief should be sympathetically acknowledged by health professionals, and parents should be reassured that their feelings are normal and that recovery may take many months. Intense depression lasting more than 6 months may require psychological treatment. There is some evidence that delaying conception for a year may allow an easier pregnancy psychologically. The common practice of encouraging parents to have contact with a dead infant is not evidence-based and may have adverse effects, including inducing symptoms of post-traumatic stress disorder. A protocol of postnatal follow-up allows parents to get appropriate information about the loss, including possible problems and timing of another pregnancy. The subsequent pregnancy is stressful, and health professionals should recognize that parents may suffer significant anxiety.

Isoflavone supplements containing predominantly genistein reduce hot flash symptoms: a critical review of published studies.

OBJECTIVE: Several reviews have evaluated the clinical evidence relating isoflavone treatment to the relief of menopausal hot flash symptoms. The majority of these reviews included a variety of isoflavone sources, often without discriminating between the identities of individual isoflavones contained in the study product. An evaluation of published studies using well-characterized isoflavone-containing supplements was conducted to determine whether the observed effects, or lack thereof, were attributable to differences in the composition of isoflavones in study products. DESIGN: Eleven studies that met the inclusion criteria were stratified according to specific isoflavone composition. RESULTS: All 11 studies contained similar total isoflavone doses. In five studies, involving a total of 177 treated participants, the study product provided more than 15 mg genistein (calculated as aglycone equivalents) per treatment. Each of these five studies consistently reported a statistically significant decrease in hot flash symptoms. In the six studies involving a total of 201 treated participants that provided less than 15 mg genistein per treatment, only one reported a statistically significant decrease in hot flash symptoms. Thus, the reduction in hot flashes was related to genistein dose, not total isoflavone content of the treatments. CONCLUSION: Reports concluding that isoflavone supplements do not significantly reduce hot flash symptoms may be incorrect. The lack of discrimination between individual isoflavones contained in heterogeneous isoflavone mixtures from differing sources can be misleading when designing studies, interpreting results, and conducting reviews. In light of these observations, evaluation of isoflavone effects should focus greater attention to the specific composition within supplements in future studies.

The psychological effects of stillbirth and neonatal death on fathers: systematic review.

OBJECTIVE: To review the available evidence on the psychological effects of perinatal death on fathers. METHOD: Electronic search of CINAHL, MEDLINE and PsycINFO databases from 1966-2005. INCLUSION CRITERIA: papers describing at least one psychological outcome for fathers who had experienced stillbirth or neonatal death. EXCLUSION CRITERIA: papers not in English, dissertations, reviews, books without original data, intervention studies, studies of parents without separate results for fathers, studies where perinatal loss was not distinguished from other losses, first person accounts of a single experience, studies reporting on fewer than five fathers. Seventy-seven potential papers were obtained and screened by two authors. Seventeen studies were included. Study quality was rated using a checklist and main findings were summarized. RESULTS: Quality of methodology varied. Qualitative studies described classical grief responses, but less guilt than mothers. Fathers described experiences related to their social role and potential conflict between grieving couples. Quantitative research reported symptoms of anxiety and depression, but at a lower level than mothers. Fathers may develop post-traumatic stress disorder following stillbirth. DISCUSSION: Case prevalence of psychological disorders is unknown. More good quality research is needed. The social role of fathers as carers for their partners needs recognition when planning care for bereaved families.

ADHD and infant disorganized attachment: a prospective study of children next-born after stillbirth.

OBJECTIVE: To examine whether infant disorganized attachment predicts ADHD at school age. METHOD: A cohort of 53 children who had been identified as having significant levels of disorganized attachment in infancy is compared to a control group. Symptoms and signs of ADHD at age 7 are evaluated together with a range of relevant maternal variables. RESULTS: An association is found between infant disorganized attachment scores and teacher-rated symptoms of ADHD (but not ADHD caseness). Probable ADHD caseness in the child is associated with self-rated retrospective ADHD scores in mothers. Possible ADHD caseness is associated with a measure of unresolved mourning in mothers. Mother-rated ADHD in the child was associated with low overall maternal psychosocial functioning. CONCLUSION: The finding of a link between scores for disorganized attachment at 1 year and later teacher-rated symptoms of ADHD suggests the need for further studies.

Psychiatrists' use of formulation: Commentary on Psychiatrists' understanding and use of psychological formulation.

Both psychologists and psychiatrists are trained to write formulations of their patients' illnesses, with some differences in how they do this. Psychologists focus on psychological understanding, while psychiatrists' formulation brings together aetiology, functioning and a management plan. Mohtashemi et al's study records how some psychiatrists understand formulation and its usefulness. Time pressure was an important barrier to making a full formulation, and some believed the medical role of the psychiatrist was a priority. The study illustrates some of the challenges facing psychiatrists working in the NHS in terms of maintaining high clinical standards and a holistic approach to patient care.

Melanin concentrating hormone (MCH): a novel neural pathway for regulation of GnRH neurons.

The link between the state of energy balance and reproductive function is well known. Thus, signals denoting negative energy balance and the accompanying hyperphagic drive are likely to be factors in the suppression of gonadotropin releasing hormone (GnRH) activity. We have previously found that appetite-regulating systems, such as neuropeptide Y (NPY) in the arcuate nucleus (ARH) and orexin in the lateral hypothalamic area (LHA), send fiber projections that come in close apposition with GnRH neurons. Furthermore, the appropriate receptors, NPY Y5 and OR-1, respectively, are coexpressed on GnRH neurons, providing neuroanatomical evidence for a direct link between the NPY and orexin systems and GnRH neurons. Therefore, these orexigenic neuropeptide systems are potential candidates that convey information about energy balance to GnRH neurons. The current studies focused on melanin concentrating hormone (MCH), another orexigenic neuropeptide system located in the LHA that is sensitive to energy balance. The results showed that MCH fiber projections came in close apposition with approximately 85-90% of GnRH cell bodies throughout the preoptic area and anterior hypothalamic area in the rat. In addition, the MCH receptor (MCHR1) was coexpressed on about 50-55% of GnRH neurons. These findings present evidence for a possible direct neuroanatomical pathway by which MCH may play a role in the regulation of GnRH neuronal function. Thus, MCH is another potential signal that may serve to integrate energy balance and reproductive function.

Preteen-parent experiences with PREP-T1 feasibility intervention.

PURPOSE: The purpose of this article is to report the focus group perspectives of preteens' and parents' experiences with a feasibility intervention entitled PREP-T1 (Preteen Re-Education with Parents-Type 1 Diabetes), an interactive education and peer mentoring intervention. METHODS: The parent and preteen focus groups were conducted by the principal investigator, coinvestigator, and note takers at 2 sites. The preteen-parent groups were conducted concurrently with a total of 11 preteens and 11 parents. Note-based qualitative content analysis was used, resulting in preteen-parent perspectives on reeducation and strategies for families to work more effectively in managing type 1 diabetes (T1DM). RESULTS: The findings suggest that the preteens enjoyed learning about their diabetes management from a teen educator mentor in conjunction with a human patient simulator. They reported this type of peer support would benefit other preteens with T1DM. Parents were overwhelmingly positive about their interactions with the parent educator mentor in conjunction with the psychologist and about focusing on how to better collaborate with their preteens on diabetes management decision making. Further recommendations about the timing and intervention dose were also discussed. CONCLUSIONS: Moderated peer mentoring with technology has potential as a means for teaching preteens and their parents shared diabetes management. These data will be used to inform the PREP-T1 fully powered intervention study.