Design and rationale of a multi-center, pragmatic, open-label randomized trial of antimicrobial therapy - the study of clinical efficacy of antimicrobial therapy strategy using pragmatic design in Idiopathic Pulmonary Fibrosis (CleanUP-IPF) clinical trial

Compelling data have linked disease progression in patients with idiopathic pulmonary fibrosis (IPF) with lung dysbiosis and the resulting dysregulated local and systemic immune response. Moreover, prior therapeutic trials have suggested improved outcomes in these patients treated with either sulfamethoxazole/ trimethoprim or doxycycline. These trials have been limited by methodological concerns. This trial addresses the primary hypothesis that long-term treatment with antimicrobial therapy increases the time-to-event endpoint of respiratory hospitalization or all-cause mortality compared to usual care treatment in patients with IPF. We invoke numerous innovative features to achieve this goal, including: 1) utilizing a pragmatic randomized trial design; 2) collecting targeted biological samples to allow future exploration of 'personalized' therapy; and 3) developing a strong partnership between the NHLBI, a broad range of investigators, industry, and philanthropic organizations. The trial will randomize approximately 500 individuals in a 1:1 ratio to either antimicrobial therapy or usual care. The site principal investigator will declare their preferred initial antimicrobial treatment strategy (trimethoprim 160 mg/ sulfamethoxazole 800 mg twice a day plus folic acid 5 mg daily or doxycycline 100 mg once daily if body weight is < 50 kg or 100 mg twice daily if ≥50 kg) for the participant prior to randomization. Participants randomized to antimicrobial therapy will receive a voucher to help cover the additional prescription drug costs. Additionally, those participants will have 4-5 scheduled blood draws over the initial 24 months of therapy for safety monitoring. Blood sampling for DNA sequencing and genome wide transcriptomics will be collected before therapy. Blood sampling for transcriptomics and oral and fecal swabs for determination of the microbiome communities will be collected before and after study completion. As a pragmatic study, participants in both treatment arms will have limited in-person visits with the enrolling clinical center. Visits are limited to assessments of lung function and other clinical parameters at time points prior to randomization and at months 12, 24, and 36. All participants will be followed until the study completion for the assessment of clinical endpoints related to hospitalization and mortality events. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT02759120

Quality Improvement for Well Child Care

Presented to the Faculty of University of Alaska Anchorage in Partial Fulfillment of Requirements for the Degree of MASTER OF SCIENCEThe American Academy of Pediatrics (AAP) Bright Futures (BF) guidelines for well child care were designed to provide quality pediatric care. Adherence to AAP-BF guidelines improves: screenings, identification of developmental delay, immunization rates, and early identification of children with special healthcare needs. The current guideline set is comprehensive and includes thirty one well child exams, thirty three universal screening exams and one hundred seventeen selective screening exams. Many providers have difficulty meeting all guideline requirements and are at risk of committing Medicaid fraud if a well exam is coded and requirements are not met. The goal of this quality improvement project was to design open source and adaptable templates for each pediatric age group to improve provider adherence to the BF guidelines. A Plan-Do-Study-Act (PDSA) quality improvement model was used to implement the project. Templates were created for ages twelve months to eighteen years and disseminated to a pilot clinic in Anchorage, Alaska. The providers were given pre-implementation and postimplementation surveys to determine the efficacy and usefulness of the templates. Templates were determined to be useful and efficient means in providing Bright Futures focused well child care. The templates are in the process of being disseminated on a large scale to assist other providers in meeting BF guideline requirements.Title Page / Table of Contents / List of Tables / List of Appendices / Abstract / Introduction / Background / Clinical Significance / Current Clinical Practice / Research Question / Literature Review / Framework: Evidence Based Practice Model/ Ethical Considerations and Institutional Review Board / Methods / Implementation Barriers / Findings / Discussion / Disseminatio

Use of programme budgeting and marginal analysis to set priorities for local NHS dental services: learning from the north east of England

Background - Priority setting is necessary where competing demands exceed the finite resources available. The aim of the study was to develop and test a prioritization framework based upon programme budgeting and marginal analysis (PBMA) as a tool to assist National Health Service (NHS) commissioners in their management of resources for local NHS dental services. Methods - Twenty-seven stakeholders (5 dentists, 8 commissioners and 14 patients) participated in a case-study based in a former NHS commissioning organization in the north of England. Stakeholders modified local decision-making criteria and applied them to a number of different scenarios. Results - The majority of financial resources for NHS dental services in the commissioning organization studied were allocated to primary care dental practitioners’ contracts in perpetuity, potentially constraining commissioners’ abilities to shift resources. Compiling the programme budget was successful, but organizational flux and difficulties engaging local NHS commissioners significantly impacted upon the marginal analysis phase. Conclusions - NHS dental practitioners’ contracts resemble budget-silos which do not facilitate local resource reallocation. ‘Context-specific’ factors significantly challenged the successful implementation and impact of PBMA. A local PBMA champion embedded within commissioning organizations should be considered. Participants found visual depiction of the cost-value ratio helpful during their initial priority setting deliberations

A randomised controlled pilot study: the effectiveness of narrative exposure therapy with adult survivors of the Sichuan earthquake

Background: Post-Traumatic Stress Disorder (PTSD) is a common psychological reaction after large-scale natural disasters. Given the number of people involved and shortage of resources in any major disaster, brief, pragmatic and easily trainable interventions are needed. The aim of this study is to evaluate the efficacy of Narrative Exposure Therapy (NET) as a short-term treatment for PTSD using Chinese earthquake survivors. Methods: A randomized waiting-list control pilot study was conducted between December 2009 and March 2010, at the site of the Sichuan earthquake in Beichuan County, China. Adult participants with newly diagnosed Post Traumatic Stress Disorder (PTSD) were randomly allocated to Narrative Exposure Therapy (NET) or a Waiting-List (WL) condition. The latter received NET treatment after a two-week waiting period. To compare the effectiveness of NET in traumatised earthquake survivors, both groups were assessed on PTSD symptoms, general mental health, anxiety and depression, social support, coping style and posttraumatic change before and after treatment and two months post treatment. Results: Adult participants (n=22) were randomly allocated to receive NET (n=11) or WL (n=11). Twenty two participants (11 in NET group, 11 in WL) were included in the analysis of primary outcomes. Compared with WL, NET showed significant reductions in PTSD symptoms, anxiety and depression, general mental stress and increased posttraumatic growth. The WL group later showed similar improvements after treatment. These changes remained stable for a two-month follow-up. Measures of social support and coping showed no stable effects. Conclusions: NET is effective in treating post-earthquake traumatic symptoms in adult Chinese earthquake survivors. The findings help advance current knowledge in the management of PTSD after natural disasters and inform future research. Larger sample sizes are needed to extend the present findings

Regulating sustainable construction in Europe: An inquiry into the European Commission's harmonization attempts

Purpose: The purpose of this paper is first, to gain insight into how the European member states have addressed the concept of sustainability in their building regulatory frameworks; and second, to gain insight in the effects of harmonization attempts o

Developing clinical decision tools to implement chronic disease prevention and screening in primary care: the BETTER 2 program (building on existing tools to improve chronic disease prevention and screening in primary care).

BackgroundThe Building on Existing Tools to Improve Chronic Disease Prevention and Screening in Family Practice (BETTER) trial demonstrated the effectiveness of an approach to chronic disease prevention and screening (CDPS) through a new skilled role of a 'prevention practitioner'(PP). The PP has appointments with patients 40-65 years of age that focus on primary prevention activities and screening of cancer (breast, colorectal, cervical), diabetes and cardiovascular disease and associated lifestyle factors. There are numerous and occasionally conflicting evidence-based guidelines for CDPS, and the majority of these guidelines are focused on specific diseases or conditions; however, primary care providers often attend to patients with multiple conditions. To ensure that high-level evidence guidelines were used, existing clinical practice guidelines and tools were reviewed and integrated into blended BETTER tool kits. Building on the results of the BETTER trial, the BETTER tools were updated for implementation of the BETTER 2 program into participating urban, rural and remote communities across Canada.MethodsA clinical working group consisting of PPs, clinicians and researchers with support from the Centre for Effective Practice reviewed the literature to update, revise and adapt the integrated evidence algorithms and tool kits used in the BETTER trial. These resources are nuanced, based on individual patient risk, values and preferences and are designed to facilitate decision-making between providers across the target diseases and lifestyle factors included in the BETTER 2 program. Using the updated BETTER 2 toolkit, clinicians 1) determine which CDPS actions patients are eligible to receive and 2) develop individualized 'prevention prescriptions' with patients through shared decision-making and motivational interviewing.ResultsThe tools identify the patients' risks and eligible primary CDPS activities: the patient survey captures the patient's health history; the prevention visit form and integrated CDPS care map identify eligible CDPS activities and facilitate decisions when certain conditions are met; and the 'bubble diagram' and 'prevention prescription' promote shared decision-making.ConclusionThe integrated clinical decision-making tools of BETTER 2 provide resources for clinicians and policymakers that address patients' complex care needs beyond single disease approaches and can be adapted to facilitate CDPS in the urban, rural and remote clinical setting.Trial registrationThe registration number of the original RCT BETTER trial was ISRCTN07170460

Evaluation of an oral health training program for school nurses

Pediatric dental disease is a silent epidemic (Committee on Health, Education, Labor, and Pensions, 2002). Dental decay is commonly unrecognized and under-treated, and can affect children\u27s growth and development as well as their ability to perform in school. Effective interventions to prevent dental decay include water fluoridation, dental sealants, pediatric dental screenings, and dental health education programs. This pre-experimental design study evaluated the effectiveness of an oral health training program for school nurses. This training program was designed based on the First 5 California \u3c;\u3eral Health Training Program (2003). A non-randomized sample of fourteen (N=l4) school nurses participated in the presentation. Pre and post test results indicated a statistically significant (p\u3c.O I) increase in oral health knowledge among the participants. As a result of this study, the researchers recommend that school nurses receive formal training in dental health assessments to effectively contribute to the improvement of pediatric oral health in the school setting

Evaluation of an Oral Health Training Program for School Nurses

Pediatric dental disease is a silent epidemic (Committee on Health, Education, Labor, and Pensions, 2002). Dental decay is commonly unrecognized and under-treated. Dental disease can affect children\u27s growth and development as well as their ability to perform in school. Effective interventions to prevent dental decay include water fluoridation, dental sealants, pediatric dental screenings, and dental health education programs. This pre-experimental design study evaluated the effectiveness of an oral health training program for school nurses. This training program was designed based on the First 5 California Oral Health Training Program, First Smiles (First Smiles Program of California, 2003). The presentation was given to a non-randomized sample of school nurses (N= 14). Pre and post test results indicated a statistically significant (p\u3c.Ol) increase in oral health knowledge among the participants. As a result of this study the researchers recommend that school nurses receive formal training in dental health assessments to effectively contribute to the improvement of pediatric oral health in the school setting

Making asset investment decisions for wastewater systems that include sustainability

Effective integrated water management is a key component of the World Water Vision and the way in which aspirations for water equity may be realized. Part of the vision includes the promotion of sustainability of water systems and full accountability for their interaction with other urban systems. One major problem is that “sustainability” remains an elusive concept, although those involved with the provision of urban wastewater systems now recognize that decisions involving asset investment should use the “triple bottom line” approach to society, the economy, and the environment. The Sustainable Water Industry Asset Resource Decisions project has devised a flexible and adaptable framework of decision support processes that can be used to include the principles of sustainability more effectively. Decision mapping conducted at the outset of the project has shown that only a narrow range of criteria currently influence the outcome of asset investment decisions. This paper addresses the concepts of sustainability assessment and presents two case studies that illustrate how multicriteria decision support systems can enhance the assessment of the relative sustainability of a range of options when decisions are being made about wastewater asset investment

Virtual Clinical Trials: One Step Forward, Two Steps Back

Virtual clinical trials have entered the medical research landscape. Today’s clinical trials recruit subjects online, obtain informed consent online, send treatments such as medications or devices to the subjects’ homes, and require subjects to record their responses online. Virtual clinical trials could be a way to democratize clinical research and circumvent geographical limitations by allowing access to clinical research for people who live far from traditional medical research centers. But virtual clinical trials also depart dramatically from traditional medical research studies in ways that can harm individuals and the public at large. This article addresses the issues presented by virtual clinical trials with regard to: (1) recruitment methods; (2) informed consent; (3) confidentiality; (4) potential risks to the subjects; and (5) the safety and efficacy of treatments that are approved