Rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART): Study protocol for a randomized controlled trial

Background: Acute respiratory distress syndrome (ARDS) is associated with high in-hospital mortality. Alveolar recruitment followed by ventilation at optimal titrated PEEP may reduce ventilator-induced lung injury and improve oxygenation in patients with ARDS, but the effects on mortality and other clinical outcomes remain unknown. This article reports the rationale, study design, and analysis plan of the Alveolar Recruitment for ARDS Trial (ART). Methods/Design: ART is a pragmatic, multicenter, randomized (concealed), controlled trial, which aims to determine if maximum stepwise alveolar recruitment associated with PEEP titration is able to increase 28-day survival in patients with ARDS compared to conventional treatment (ARDSNet strategy). We will enroll adult patients with ARDS of less than 72 h duration. The intervention group will receive an alveolar recruitment maneuver, with stepwise increases of PEEP achieving 45 cmH(2)O and peak pressure of 60 cmH2O, followed by ventilation with optimal PEEP titrated according to the static compliance of the respiratory system. In the control group, mechanical ventilation will follow a conventional protocol (ARDSNet). In both groups, we will use controlled volume mode with low tidal volumes (4 to 6 mL/kg of predicted body weight) and targeting plateau pressure <= 30 cmH2O. The primary outcome is 28-day survival, and the secondary outcomes are: length of ICU stay; length of hospital stay; pneumothorax requiring chest tube during first 7 days; barotrauma during first 7 days; mechanical ventilation-free days from days 1 to 28; ICU, in-hospital, and 6-month survival. ART is an event-guided trial planned to last until 520 events (deaths within 28 days) are observed. These events allow detection of a hazard ratio of 0.75, with 90% power and two-tailed type I error of 5%. All analysis will follow the intention-to-treat principle. Discussion: If the ART strategy with maximum recruitment and PEEP titration improves 28-day survival, this will represent a notable advance to the care of ARDS patients. Conversely, if the ART strategy is similar or inferior to the current evidence-based strategy (ARDSNet), this should also change current practice as many institutions routinely employ recruitment maneuvers and set PEEP levels according to some titration method.

Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials

BACKGROUND: Neovascular age-related macular degeneration (AMD) has a poor prognosis if left untreated, frequently resulting in legal blindness. Ranibizumab is approved for treating neovascular AMD. However, further guidance is needed to assist ophthalmologists in clinical practice to optimise treatment outcomes. METHODS: An international retina expert panel assessed evidence available from prospective, multicentre studies evaluating different ranibizumab treatment schedules (ANCHOR, MARINA, PIER, SAILOR, SUSTAIN and EXCITE) and a literature search to generate evidence-based and consensus recommendations for treatment indication and assessment, retreatment and monitoring. RESULTS: Ranibizumab is indicated for choroidal neovascular lesions with active disease, the clinical parameters of which are outlined. Treatment initiation with three consecutive monthly injections, followed by continued monthly injections, has provided the best visual-acuity outcomes in pivotal clinical trials. If continued monthly injections are not feasible after initiation, a flexible strategy appears viable, with monthly monitoring of lesion activity recommended. Initiation regimens of fewer than three injections have not been assessed. Continuous careful monitoring with flexible retreatment may help avoid vision loss recurring. Standardised biomarkers need to be determined. CONCLUSION: Evidence-based guidelines will help to optimise treatment outcomes with ranibizumab in neovascular AMD.

Assessment of publication bias in dental specialty journals

OBJECTIVE: The purpose of this study was to investigate the presence of publication bias (acceptance of articles indicating statistically significant results). METHODS: The journals possessing the highest impact factor (2008 data) in each dental specialty were included in the study. The content of the 6 most recent issues of each journal was hand searched and research articles were classified into 4 type categories: cross-sectional, case-control, cohort, and interventional (nonrandomized clinical trials and randomized controlled trials). In total, 396 articles were included in the analysis. Descriptive statistics and univariate and multivariate logistic regression was used to examine the association between article-reported statistical significance (dependent variable) and journal impact factor and article study type subject area (independent variables). RESULTS: A statistically significant acceptance rate of positive result was found, ranging from 75% to 90%, whereas the value of impact factor was not related to publication bias among leading dental journals. Compared with other research designs, clinical intervention studies (randomized or nonrandomized) presented the highest percentage of nonsignificant findings (20%); RCTs represented 6% of the examined investigations. CONCLUSIONS: Compared with the Journal of Clinical Periodontology, all other subspecialty journals, except the Journal of Oral and Maxillofacial Surgery, showed significantly decreased odds of publishing an RCT, which ranged from 60% to 93% (P < .05).

Reporting Experiments in Homeopathic Basic Research—Description of the Checklist Development

The objective of this study was to develop a criteria catalogue serving as a guideline for authors to improve quality of reporting experiments in basic research in homeopathy. A Delphi Process was initiated including three rounds of adjusting and phrasing plus two consensus conferences. European researchers who published experimental work within the last 5 years were involved. A checklist for authors provide a catalogue with 23 criteria. The “Introduction” should focus on underlying hypotheses, the homeopathic principle investigated and state if experiments are exploratory or confirmatory. “Materials and methods” should comprise information on object of investigation, experimental setup, parameters, intervention and statistical methods. A more detailed description on the homeopathic substances, for example, manufacture, dilution method, starting point of dilution is required. A further result of the Delphi process is to raise scientists' awareness of reporting blinding, allocation, replication, quality control and system performance controls. The part “Results” should provide the exact number of treated units per setting which were included in each analysis and state missing samples and drop outs. Results presented in tables and figures are as important as appropriate measures of effect size, uncertainty and probability. “Discussion” in a report should depict more than a general interpretation of results in the context of current evidence but also limitations and an appraisal of aptitude for the chosen experimental model. Authors of homeopathic basic research publications are encouraged to apply our checklist when preparing their manuscripts. Feedback is encouraged on applicability, strength and limitations of the list to enable future revisions.

Getting started with taiji: investigating students expectations and teachers appraisals of taiji beginners courses

In recent years, Taiji has been frequently investigated and considered as a stress management intervention. Although health care providers' appraisals and consumers' expectations are regarded as essential for treatment outcome, little attention has been drawn to this issue in Taiji research. In our study we have conducted two surveys to explore beginners' (n = 74) expectations and teachers' (n = 136) appraisals of their Taiji courses in general as well as more particularly related to stress management. Qualitative data analysis revealed that beginners mainly expected to learn a new method that is applicable in their daily life to foster peace of mind and to enhance their stress management. Congruently moderate-to-high improvements in stress management have also been found in quantitative analysis, whereby a lower educational level predicted higher expectations (P = 0.016). Taiji-teachers stated body- and mind-related benefits most frequently and appraised moderate-to-high improvements in stress management. Higher appraisals were predicted by a shorter teaching experience (P = 0.024). Our results inform about beginners' expectations and teachers' appraisals related to a Taiji-beginners course and highlight the role of educational background and teaching experience in shaping stress-management-related beginners' expectations and teachers' appraisals.

Ordering CT pulmonary angiography to exclude pulmonary embolism: defense versus evidence in the emergency room

To identify reasons for ordering computed tomography pulmonary angiography (CTPA), to identify the frequency of reasons for CTPA reflecting defensive behavior and evidence-based behavior, and to identify the impact of defensive medicine and of training about diagnosing pulmonary embolism (PE) on positive results of CTPA.

The precipitous decline of the ortolan bunting Emberiza hortulana: time to build on scientific evidence to inform conservation management

In recent decades there has been a marked decline in most ortolan bunting Emberiza hortulana populations in temperate Europe, with many regional populations now extinct or on the brink of extinction. In contrast, Mediterranean and, as far as we know, eastern European popula-tions seem to have remained relatively stable. The causes of decline remain unclear but include: habitat loss and degradation, and related reduction in prey availability; climate change on the breeding grounds; altered population dynamics; illegal captures during migration; and environmental change in wintering areas. We review the current knowledge of the biology of the ortolan bunting and discuss the proposed causes of decline in relation to the different population trends in temperate and Mediterranean Europe. We suggest new avenues of research to identify the factors limiting ortolan bunting populations. The main evidence-based conservation measure that is likely to enhance habitat quality is the creation of patches of bare ground to produce sparsely vegetated foraging grounds in invertebrate-rich grassy habitats close to breeding areas.

Diabetes and acute coronary syndromes

Diabetic patients with acute coronary syndromes (ACSs) are at a high risk for subsequent cardiovascular events but derive, at the same time, greater benefit from evidence-based therapy than non-diabetic individuals. State-of-the-art anti-thrombotic therapy includes a triple anti-platelet combination - aspirin, clopidogrel and glycoprotein (GP) IIb/IIIa receptor inhibitors - and unfractionated heparin or enoxaparin. For low- or medium-risk individuals, a treatment based on aspirin, clopidogrel and bivalirudin is a valuable alternative. Prasugrel, a new and more potent inhibitor of the platelet P2Y(12) receptor, has to be regarded as the most promising anti-thrombotic agent for diabetic patients with ACS. This agent may replace clopidogrel - and possibly GP IIb/IIIa inhibitors - in the future. In addition to aggressive anti-thrombotic therapy, diabetic patients should undergo systematic early invasive angiography if presenting with non-ST-segment elevation ACS, and immediate percutaneous coronary intervention if presenting with ST-segment elevation myocardial infarction. Indeed, the benefit derived from these strategies appears to be more pronounced in the diabetic population than in non-diabetic individuals. Despite the benefit, multiple surveys have demonstrated that, in the setting of ACS, diabetic patients receive evidence-based therapy less frequently than non-diabetic counterparts.

Evidence Focused Social Care: on Target or Off-Side?

As contentions continue to engulf the evidence-based practice (EBP) debate within social care, consensus seems to be gravitating towards the softer term of ‘evidence-aware’ practice, although there is as yet no definitive concept on the horizon. Set against a back-drop of competing ideologies, heavily influenced by the natural sciences, what is at stake is the essence of social work: there is a real danger that social work practice be reduced to mere base elements, which seek to eliminate all notions of uncertainly, so essential and endemic to our social world

Desertification mitigation and water harvesting based on sustainable land management

Traditionally, desertification research has focused on degradation assessments, whereas prevention and mitigation strategies have not sufficiently been emphasised, although the concept of sustainable land management (SLM) is increasingly being acknowledged. SLM strategies are interventions at the local to regional scale aiming at increasing productivity, protecting the natural resource base, and improving livelihoods. The global WOCAT initiative and its partners have developed harmonized frameworks to compile, evaluate and analyse the impact of SLM practices around the globe. Recent studies within the EU research project DESIRE developed a methodological framework that combines a collective learning and decision-making approach with use of best practices from the WOCAT database. In-depth assessment of 30 technologies and 8 approaches from 17 desertification sites enabled an evaluation of how SLM addresses prevalent dryland threats such as water scarcity, soil and vegetation degradation, low production, climate change, resource use conflicts and migration. Among the impacts attributed to the documented technologies, those mentioned most were diversified and enhanced production and better management of water and soil degradation, whether through water harvesting, improving soil moisture, or reducing runoff. Water harvesting offers under-exploited opportunities for the drylands and the predominantly rainfed farming systems of the developing world. Recently compiled guidelines introduce the concepts behind water harvesting and propose a harmonised classification system, followed by an assessment of suitability, adoption and up-scaling of practices. Case studies go from large-scale floodwater spreading that make alluvial plains cultivable, to systems that boost cereal production in small farms, as well as practices that collect and store water from household compounds. Once contextualized and set in appropriate institutional frameworks, they can form part of an overall adaptation strategy for land users. More field research is needed to reinforce expert assessments of SLM impacts and provide the necessary evidence-based rationale for investing in SLM. This includes developing methods to quantify and value ecosystem services, both on-site and off-site, and assess the resilience of SLM practices, as currently aimed at within the new EU CASCADE project.

Choosing and Maintaining Programs for Sex Education in Schools: The CHAMPSS Model

Background: Despite effective solutions to reduce teen birth rates, Texas teen birth rates are among the highest in the nation. School districts can impact youth sexual behavior through implementation of evidence-based programs (EBPs); however, teen pregnancy prevention is a complex and controversial issue for school districts. Subsequently, very few districts in Texas implement EBPs for pregnancy prevention. Additionally, school districts receive little guidance on the process for finding, adopting, and implementing EBPs. Purpose: The purpose of this report is to present the CHoosing And Maintaining Programs for Sex education in Schools (CHAMPSS) Model, a practical and realistic framework to help districts find, adopt, and implement EBPs. Methods: Model development occurred in four phases using the core processes of Intervention Mapping: 1) knowledge acquisition, 2) knowledge engineering, 3) model representation, and 4) knowledge development. Results: The CHAMPSS Model provides seven steps, tailored for school-based settings, which encompass phases of assessment, preparation, implementation, and maintenance: Prioritize, Asses, Select, Approve, Prepare, Implement, and Maintain. Advocacy and eliciting support for adolescent sexual health are also core elements of the model. Conclusion: This systematic framework may help schools increase adoption, implementation, and maintenance for EBPs.

Current Resources

Reviews of: Children Who Could Have Been: The Legacy of Child Welfare in Wealthy America. (1999) William M. Epstein Madison, Wisconsin: University of Wisconsin Press Reviewed by: Leroy H Pelton Skills for Families Skills for Life. (1999) Linda M. Shadoin, Joni Cook-Griffin, and JaneL. Peterson. Nebraska: Boys Town Press. Reviewed by Shelley Leavitt Attachment Disorganization. (1999) J. and George C. Solomon, Eds. New York: The Guilford Press. Reviewed by Alice Chornesky Infants. Toddlers. and Families: A Framework for Support and Intervention. (1999) Martha Farrell Erickson and Karen Kurz-Riemer.New York: The Guilford Press.Reviewed by Halaevalu F. Vakalahi Solution-Based Casework: An Introduction to Clinical and Case Management Skills in Casework Practice. (1999) D. N. Christensen, J. Todahl, and W. C. Barrett New York: Aldine De Gruyter.Reviewed by Charles H Huber Childhood Sexual Abuse: An Evidence-Based Perspective. (1999) David M. Fergusson and Paul E. Mullen Thousand Oaks, Sage Publications, Inc.Reviewed by Elaine S. LeVine Spiritual Resources in Family Therapy. (1999) F. Walsh. New York: Guilford Press.Reviewed by David Derezotes

Pathways to care in subjects at high risk for psychotic disorders — A European perspective

Evidence-based decisions on indicated prevention in early psychosis require large-scale studies on the pathways to care in high-risk subjects. EPOS (The European Prediction of Psychosis Study), a prospective multi-center, naturalistic field study in four European countries (Finland, Germany, The Netherlands and England), was designed to acquire accurate knowledge about pathways to care and delay in obtaining specialized high risk care. Our high risk sample (n=233) reported on average 2.9 help-seeking contacts, with an average delay between onset of relevant problems to initial help-seeking contact of 72.6 weeks, and between initial help-seeking contact and reaching specialized high risk care of 110.9 weeks. This resulted in a total estimated duration of an unrecognized risk for psychosis of 3 ½ years. Across EPOS EU regions, about 90% of care pathway contacts were within professional health care sectors. Between EPOS regions, differences in the pathways parameters including early detection and health-care systems were often very pronounced. High-risk participants who later made transition to a full psychotic disorder had significantly longer delays between initial help-seeking and receiving appropriate interventions. Our study underlines the need for regionally adapted implementation of early detection and intervention programs within respective mental health and health care networks, including enhancing public awareness of early psychosis.

Effects of Passive Hydrotherapy WATSU (WaterShiatsu) in the Third Trimester of Pregnancy: Results of a Controlled Pilot Study

Background. WATSU (WaterShiatsu) is a complementary therapeutic treatment method comprising passive stretches and massage techniques administered in 35°C warm water. Pregnant women claim safe methods to reduce pain, stress, and fatigue. Therefore, we conducted a pilot study evaluating the effects of WATSU on pregnancy-related complaints in third trimester pregnant women. Methods. Nine healthy pregnant women at gestational week ≥34 were included in an intervention group (receiving WATSU) and compared to eight women in a passive control group (receiving no treatment). WATSU was performed on days 1 and 4 of the study, accompanied by ultrasound examinations. Outcomes include physiological and psychometric as well as qualitative data. Participants in the control group completed questionnaires only. Results. WATSU was found to significantly lower participants’ levels of stress and pain and to improve their mental health-related quality of life and mood. In comparison to the passive control group, participants in the intervention group reported reduction in perceived stress from day 1 to day 8 (p = 0.036, Cohen’s f = 0.57). Qualitative data indicate that WATSU was appreciated as enjoyable and deeply relaxing. No negative side effects were reported. Conclusion. Our findings support the notion that WATSU yields therapeutic benefits for pregnant women and warrant further research. This study has been registered at ClinicalTrials.gov: NCT01708018.

Excision of fascia in melanoma thicker than 2 mm: no evidence for improved clinical outcome.

BACKGROUND Lack of evidence-based data causes significant variation among surgeons concerning the depth of wide excision for primary cutaneous melanomas. OBJECTIVES To evaluate the clinical effect of excision of the deep fascia in melanomas thicker than 2 mm on patient outcome. METHODS We performed a retrospective cohort review (1996-2012) of patients with melanomas thicker than 2 mm. Included patients underwent excision with a 1-cm margin. Data collected included the patients' sex, age, tumour location, tumour type, Breslow depth and presence of ulceration. Local recurrences, locoregional and distant metastases, and disease-free and overall survival were compared between the fascia-excised and the fascia-preserved groups. RESULTS Out of 2182 patients with malignant melanomas, 213 melanomas thicker than 2 mm, with a median follow-up of 1547 days, were included. The mean age of the patients was 62·6 years and the mean Breslow depth was 4·2 mm. Analysis of data for death attributable to melanoma (P = 0·72), local recurrence (P = 0·71), and locoregional (P = 0·87) and distant metastases (P = 0·34) were not significantly different between the study groups. Furthermore, Kaplan-Meier and Cox regression analysis of both groups showed no evidence of significant difference regarding disease-free [P = 0·35; hazard ratio (HR) 1·25; 95% confidence interval (CI) 0·79-1·97] and overall survival (P = 0·63; HR 1·18; 95% CI 0·61-2·27). CONCLUSIONS We believe that excision of the deep fascia does not improve the outcome of melanomas thicker than 2 mm.