Interventions for treating hyperemesis gravidarum.

BACKGROUND: Hyperemesis gravidarum is a severe form of nausea and vomiting in pregnancy affecting 0.3% to 1.0% of pregnancies, and is one of the most common indications for hospitalization during pregnancy. While a previous Cochrane review examined interventions for nausea and vomiting in pregnancy, there has not yet been a review examining the interventions for the more severe condition of hyperemesis gravidarum. OBJECTIVES: To assess the effectiveness and safety, of all interventions for hyperemesis gravidarum in pregnancy up to 20 weeks\u27 gestation. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group\u27s Trials Register and the Cochrane Complementary Medicine Field\u27s Trials Register (20 December 2015) and reference lists of retrieved studies. SELECTION CRITERIA: Randomized controlled trials of any intervention for hyperemesis gravidarum. Quasi-randomized trials and trials using a cross-over design were not eligible for inclusion.We excluded trials on nausea and vomiting of pregnancy that were not specifically studying the more severe condition of hyperemesis gravidarum. DATA COLLECTION AND ANALYSIS: Two review authors independently reviewed the eligibility of trials, extracted data and evaluated the risk of bias. Data were checked for accuracy. MAIN RESULTS: Twenty-five trials (involving 2052 women) met the inclusion criteria but the majority of 18 different comparisons described in the review include data from single studies with small numbers of participants. The comparisons covered a range of interventions including acupressure/acupuncture, outpatient care, intravenous fluids, and various pharmaceutical interventions. The methodological quality of included studies was mixed. For selected important comparisons and outcomes, we graded the quality of the evidence and created \u27Summary of findings\u27 tables. For most outcomes the evidence was graded as low or very low quality mainly due to the imprecision of effect estimates. Comparisons included in the \u27Summary of findings\u27 tables are described below, the remaining comparisons are described in detail in the main text.No primary outcome data were available when acupuncture was compared with placebo, There was no clear evidence of differences between groups for anxiodepressive symptoms (risk ratio (RR) 1.01, 95% confidence interval (CI) 0.73 to 1.40; one study, 36 women, very low-quality evidence), spontaneous abortion (RR 0.48, 95% CI 0.05 to 5.03; one study, 57 women, low-quality evidence), preterm birth (RR 0.12, 95% CI 0.01 to 2.26; one study, 36 women, low-quality evidence), or perinatal death (RR 0.57, 95% CI 0.04 to 8.30; one study, 36 women, low-quality evidence).There was insufficient evidence to identify clear differences between acupuncture and metoclopramide in a study with 81 participants regarding reduction/cessation in nausea or vomiting (RR 1.40, 95% CI 0.79 to 2.49 and RR 1.51, 95% CI 0.92 to 2.48, respectively; very low-quality evidence).In a study with 92 participants, women taking vitamin B6 had a slightly longer hospital stay compared with placebo (mean difference (MD) 0.80 days, 95% CI 0.08 to 1.52, moderate-quality evidence). There was insufficient evidence to demonstrate a difference in other outcomes including mean number of episodes of emesis (MD 0.50, 95% CI -0.40 to 1.40, low-quality evidence) or side effects.A comparison between metoclopramide and ondansetron identified no clear difference in the severity of nausea or vomiting (MD 1.70, 95% CI -0.15 to 3.55, and MD -0.10, 95% CI -1.63 to 1.43; one study, 83 women, respectively, very low-quality evidence). However, more women taking metoclopramide complained of drowsiness and dry mouth (RR 2.40, 95% CI 1.23 to 4.69, and RR 2.38, 95% CI 1.10 to 5.11, respectively; moderate-quality evidence). There were no clear differences between groups for other side effects.In a single study with 146 participants comparing metoclopramide with promethazine, more women taking promethazine reported drowsiness, dizziness, and dystonia (RR 0.70, 95% CI 0.56 to 0.87, RR 0.48, 95% CI 0.34 to 0.69, and RR 0.31, 95% CI 0.11 to 0.90, respectively, moderate-quality evidence). There were no clear differences between groups for other important outcomes including quality of life and other side effects.In a single trial with 30 women, those receiving ondansetron had no difference in duration of hospital admission compared to those receiving promethazine (MD 0.00, 95% CI -1.39 to 1.39, very low-quality evidence), although there was increased sedation with promethazine (RR 0.06, 95% CI 0.00 to 0.94, low-quality evidence) .Regarding corticosteroids, in a study with 110 participants there was no difference in days of hospital admission compared to placebo (MD -0.30, 95% CI -0.70 to 0.10; very low-quality evidence), but there was a decreased readmission rate (RR 0.69, 95% CI 0.50 to 0.94; four studies, 269 women). For other important outcomes including pregnancy complications, spontaneous abortion, stillbirth and congenital abnormalities, there was insufficient evidence to identify differences between groups (very low-quality evidence for all outcomes). In other single studies there were no clear differences between groups for preterm birth or side effects (very low-quality evidence).For hydrocortisone compared with metoclopramide, no data were available for primary outcomes and there was no difference in the readmission rate (RR 0.08, 95% CI 0.00 to 1.28;one study, 40 women).In a study with 80 women, compared to promethazine, those receiving prednisolone had increased nausea at 48 hours (RR 2.00, 95% CI 1.08 to 3.72; low-quality evidence), but not at 17 days (RR 0.81, 95% CI 0.58 to 1.15, very low-quality evidence). There was no clear difference in the number of episodes of emesis or subjective improvement in nausea/vomiting. There was insufficient evidence to identify differences between groups for stillbirth and neonatal death and preterm birth. AUTHORS\u27 CONCLUSIONS: On the basis of this review, there is little high-quality and consistent evidence supporting any one intervention, which should be taken into account when making management decisions. There was also very limited reporting on the economic impact of hyperemesis gravidarum and the impact that interventions may have.The limitations in interpreting the results of the included studies highlights the importance of consistency in the definition of hyperemesis gravidarum, the use of validated outcome measures, and the need for larger placebo-controlled trials

IT service management: process capability, process performance, and business performance

As technology is at the core of almost every leading industry, organizations are increasingly scrutinizing their Information Technology (IT) group’s performance so that it is more in line with overall business performance and contributes to the business’ bottom line. Many IT departments are not equipped to meet these increasing IT service demands. They continue to operate as passive-reactive service providers, utilizing antiquated methods that do not adequately provide the quality, real-time solutions that organizations need to be competitive. Organizations need efficient Information Technology Service Management (ITSM) processes in order to cut costs, but ironically, in order to implement highly capable processes, there are significant costs involved, both in terms of time and resources. A potential way to achieve better performing and higher capable processes is to employ methods to compare an organization’s processes against best-practice standards to identify gaps and receive guidance to improve the processes. Many of the existing methods require large investments. Holding back progress towards best practice for financial benefit in the IT industry is the reluctance of many IT organizations to embrace the business side (specifically Service Portfolio Management and IT Financial Management) aspects of ITSM. Service Portfolio Management (SPM) is used to manage investments in Service Management across an organization, in terms of financial values. SPM enables managers to assess the quality requirements and associated costs. IT Financial Management aims to provide information on the IT assets and resources used to deliver IT services. Providing a Service Portfolio and practicing IT Financial Management requires a high level of maturity for an organization. It seems reasonable and logical that the organization’s Chief Information Officer should be able to articulate and justify the IT services provided, report the costs (by service) incurred in delivering these services, and can communicate the demand for those services, that is, how they are being consumed and projections on how they will be consumed in the future. However, a major investment in terms of time and resources may be needed to catalogue such information and report on it. The research problem that this paper addresses is the lack of a pragmatic model and method that associates ITSM process maturity (process capability and performance) with financial performance for organizations that lack mature ITSM processes. Previous studies have reported on cost savings, but there is currently no measurement model to associate ITSM maturity with financial profitability; which in turn prompts the research question: How can the association of ITSM process capability and process performance with financial performance of an organization be determined? This research iteratively develops and applies a measurement model that presents a pragmatic and cost-effective method to link ITSM process capability and process performance with business performance by operationalizing Key Performance Indicators (KPIs) to support Critical Success Factors (CSFs) and associating CSFs with business risks to determine business performance. This study employs a scholar-practitioner approach to changing/improving processes using action research and an adaptation of the Keys to IT Service Management Excellence Technique (KISMET) model to guide the process improvement initiative. This technique leads to the second research question: How can the ITSM measurement framework be demonstrated for CSI? The research was based on a single case study of a global financial services firm Company X that had implemented the ITIL® framework to improve the quality of its IT services. The study found that the measurement framework developed can be used as a starting point for self-improvement for businesses, identifying gaps in processes, benchmarking within an organization as well as guiding an organization’s process improvement efforts. The measurement model can be used to conduct What-If analyses to model the impacts of future business decisions on KPIs and CSFs. The measurement model presented in this study can be quickly implemented, adapted and evolved to meet the organization’s needs. The research offers an example from which other organizations can learn to measure their financial return on investment in ITSM improvement

Recruitment to randomised controlled trials with children

Recruitment to randomised controlled trials is known to be difficult. Poor recruitment has several adverse consequences. It affects the validity of study findings, is a common cause of trial extensions and may result in premature termination of trials, which is a huge loss in terms of invested funds, resources and lost knowledge. Non-completion or delayed completion of studies maintains the uncertainty about the efficacy and safety of interventions, thereby delaying or preventing the use of effective interventions and prolonging the use of ineffective or potentially harmful treatments. Recruitment of children to randomised controlled trials is thought to be more challenging due to the vulnerability of the population and the fact that consent is provided by another person usually parents. This thesis aims to review the recruitment performance, i.e. comparison of achieved to anticipated recruitment, of randomised controlled trials with children and identify the factors associated with good or poor recruitment. We undertook a pilot systematic review of recruitment and retention in randomised controlled trials with children, in published literature, and found that few studies report recruitment information but those that do, report very high rates of percentage total recruitment achieved (%TR) and consent. It was not possible to obtain unbiased estimates of recruitment performance and consent rate due to the likelihood of selective reporting and/or non-publication of trials with unsuccessful recruitment. We subsequently conducted a review of recruitment of children to randomised controlled trials in the National Institute of Health Research (NIHR) Clinical Research Network (CRN) portfolio and found that under-recruitment and delayed recruitment are common problems in paediatric trials. Having a trial manager or coordinator was found to be significantly associated with successful recruitment. Other factors such as being an IMP (Investigational Medicinal Product) vs. non-IMP trial, trial of acute vs. chronic illness, having CTU (Clinical Trials Unit) involvement, pilot/feasibility study and additional trial demands had no statistically significant association with recruitment success. Since recruitment to a clinical trial can be affected by a number of internal and external factors, we conducted a survey with the clinical teams of a multi-centre randomised controlled trial with children, the MAGNETIC trial, to understand the various facilitators and barriers to recruitment. In order to identify the facilitators and barriers to recruitment and establish the recruitment experience of clinical teams in a systematic manner, we developed an evidence based recruitment survey tool. The survey tool is an online questionnaire that presents a comprehensive evidence based list of facilitators and barriers and free text space for responders to record the strategies applied to overcome these barriers and suggestions for change in organisation of trials to boost recruitment. The survey of clinical teams recruiting to the MAGNETIC trial found that a motivated clinical team with effective communication skills, effective coordination between study team members at site and between sites and CTU, trial management support, research experience of PI, presence of a research nurse and availability of a designated research team were imperative for trial recruitment success. Heavy clinical workload, shift patterns of work, lack of trained staff particularly out of hours, GCP training, local clinical arrangements and parental anxiety about the safety of experimental treatment were recognised as important barriers to recruitment. A trial specific barrier was difficulty faced by the clinicians in seeking consent from the parents of an acutely ill child in the emergency setting and suggestions were made for consideration of deferred consent. We concluded that recruitment to randomised controlled trials with children is challenging and poor recruitment and recruitment delays are a common problem. Reporting of recruitment and consent in paediatric trials is poor and needs improvement. Presence of a dedicated trial manager is significantly associated with successful recruitment and the various generic and trial specific facilitators and barriers to recruitment that have been identified can be used by trialists in planning and conducting future clinical trials with children

Yale Medicine : Alumni Bulletin of the School of Medicine, Autumn 2005- Spring 2006

This volume contains Yale medicine: alumni bulletin of the School of Medicine, v.40 (Autumn 2005-Spring 2006). Prepared in cooperation with the alumni and development offices at the School of Medicine. Earlier volumes are called Yale School of Medicine alumni bulletins, dating from v.1 (1953) through v.13 (1965). Digitized with funding from the Arcadia fund, 2017.https://elischolar.library.yale.edu/yale_med_alumni_newsletters/1021/thumbnail.jp

An empirical analysis of top management team strategic cognition, managerial attributes, audit committee effectiveness and their implications for corporate risk and performance

The events of the global financial crisis have hastened the refinement of existing corporate governance regulations and the development of new ones to strengthen corporate governance mechanisms. However, critics of this approach argue that strengthening the corporate governance system by itself cannot guarantee better organizational outcomes. Rather, understanding the cognitive footprints of the top management team (top management strategic cognition) and its implications on organizational outcomes represent a better alternative. Currently, empirical research that examines the effects of top management team (TMT) strategic cognition on firm outcomes is scarce and sparse. Therefore, our knowledge and understanding of how TMT cognitive structures (mental models) influence organizational outcomes is limited and scattered. This study uses a sample of balanced panel data from 311 UK FTSE companies from 2007 to 2016 to examine the effects of TMT strategic cognition on organizational outcomes. Since TMT members differ in their cognitive structures, both researchers and policy makers find it difficult to identify specific cognitive elements that can secure optimum organizational outcomes. The motivation for this thesis is to contribute to the corporate governance literature by presenting a unique decision making framework that examines six different top management strategic cognition pathways and how the elements in each pathway influences firm outcomes. This thesis uses the partial least squares- structural equation modelling (PLS-SEM) and fixed effects estimation methods. The findings based on this thesis provide three original contributions to the literature. First, the results show that a TMT strategic cognition that combines innovativeness and high risk preference can secure better organizational outcomes. Second, the analyses further show that firms that have experienced accounting and finance experts and communicate more about their corporate sustainability to their stakeholders perform better in both crisis periods and stable periods. Third, a bankruptcy model that combines managerial attributes, accounting data and market data can provide a better prediction of a firm’s bankruptcy probability and the variability in its market returns