Lassa fever (LF) is a devastating hemorrhagic viral disease that is endemic to West Africa and responsible for thousands of human deaths each year. Analysis of humoral immune responses (IgM and IgG) by antibody-capture ELISA (Ab-capture ELISA) and Lassa virus (LASV) viremia by antigen-capture ELISA (Ag-capture ELISA) in suspected patients admitted to the Kenema Government Hospital (KGH) Lassa Fever Ward (LFW) in Sierra Leone over the past five years is reshaping our understanding of acute LF.Analyses in LF survivors indicated that LASV-specific IgM persists for months to years after initial infection. Furthermore, exposure to LASV appeared to be more prevalent in historically non-endemic areas of West Africa with significant percentages of reportedly healthy donors IgM and IgG positive in LASV-specific Ab-capture ELISA. We found that LF patients who were Ag positive were more likely to die than suspected cases who were only IgM positive. Analysis of metabolic and immunological parameters in Ag positive LF patients revealed a strong correlation between survival and low levels of IL-6, -8, -10, CD40L, BUN, ALP, ALT, and AST. Despite presenting to the hospital with fever and in some instances other symptoms consistent with LF, the profiles of Ag negative IgM positive individuals were similar to those of normal donors and nonfatal (NF) LF cases, suggesting that IgM status cannot necessarily be considered a diagnostic marker of acute LF in suspected cases living in endemic areas of West Africa.Only LASV viremia assessed by Ag-capture immunoassay, nucleic acid detection or virus isolation should be used to diagnose acute LASV infection in West Africans. LASV-specific IgM serostatus cannot be considered a diagnostic marker of acute LF in suspected cases living in endemic areas of West Africa. By applying these criteria, we identified a dysregulated metabolic and pro-inflammatory response profile conferring a poor prognosis in acute LF. In addition to suggesting that the current diagnostic paradigm for acute LF should be reconsidered, these studies present new opportunities for therapeutic interventions based on potential prognostic markers in LF. Arenaviridae family and is the etiologic agent of LF, which is an acute and often fatal illness endemic in West Africa. There are an estimated 300,000 - 500,000 cases of LF each year [LASV is a member of the ach year -7 with aach year ,9 and 90ach year , and theach year ,8,9. The® blood chemistry analyzer coupled with comprehensive metabolic panel disks. Flow cytometry powered by a 4-color Accuri® C6 cytometer performs immunophenotyping, intracellular cytokine and bead-based secreted cytokine analysis on patient sera. These resources contributed to advances in real time diagnosis along with metabolic and immunological characterization of acute LF, thus resulting in a marked improvement in the management of the disease. Herein we present evidence that introduces new insight into humoral and cellular immune responses to LASV that have lead us to reevaluate the role of LASV IgM seropositivity in diagnosing acute LF in suspected cases living in the LASV endemic areas of West Africa. An improved understanding of the natural history of LF will be helpful in guiding future research in diagnosis and treatment.Since 2005, continuous infrastructure improvements at the KGH Lassa Fever Laboratory (LFL) by the National Institutes of Health (United States), the Department of Defense (DoD), the Naval Facilities Engineering Command (NAVFAC), the United States Army Medical Research Institute of Infectious Diseases (USAMRIID), the World Health Organization (WHO), Global Viral Forecasting (GVF) and Tulane University have resulted in the implementation of sophisticated, on-site diagnostic and research capabilities ,12. CurrSuspected LF patients, individuals reporting close contact with confirmed LF patients, and healthy volunteers were eligible to participate in these studies as outlined in Tulane University's Institutional Review Board (IRB) protocol, National Institutes of Health/National Institutes of Allergy and Infectious Diseases (NIH/NIAID) guidelines governing the use of human subjects for research, and Department of Health and Human Services (HHS)/NIH/NIAID Challenge and Partnership Grant Numbers AI067188 and AI082119 and HHS Contract HHSN272200900049C. The Tulane University IRB has approved these projects. All subjects participating in the study gave written informed consent to the publication of their case details.g, 20 minutes at room temperature). The serum fraction was collected for analysis, and aliquots were stored in cryovials at -20°C. Sera from a panel of 50 randomized U.S. male donors were purchased from Bioreclamation, Inc. , and a similar panel of 50 U.S. female donors was obtained from SeraCare Life Sciences, Inc. . All U. S. donors were at least 18 years of age and reported their ethnic groups as Caucasian, Hispanic, or African American.Small blood volumes , for serum separation were collected from study subjects with consent from the attending physician. Blood from healthy Sierra Leonean volunteers were used as normal controls. Three groups of normal donors were assembled for this study: 1) non-febrile volunteers comprised of Lassa program staff from Kenema district and nursing staff from a hospital in Bo, Sierra Leone, who reported to be in generally good health at the time of blood collection; 2) volunteers from randomly-chosen, historically non-endemic villages in the District of Moyamba (N = 101) and the District of Bombali (N = 13) that also reported to be in generally good health, not having any recent illnesses or having travelled to Africa's Eastern Province. Both patients and healthy volunteer samples received a coded designation and were collected in serum vacutainer tubes and allowed to coagulate for 20 minutes at room temperature. Serum was separated from coagulated blood by centrifugation -specific Ag were measured using LASV Antigen Rapid Test cassettes and dipstick LFI currently under pre-clinical development by Corgenix Medical Corp.  and the Viral Hemorrhagic Fever Consortium (see acknowledgements), as described by Grove et al. . PositivIndividual recombinant LASV (reLASV) proteins  and combinations of reLASV proteins optimized for detection of virus-specific IgM and IgG levels in serum were coated in stripwell plates at Corgenix Medical Corp. and packaged as test kits. Detection of LASV-specific IgM and IgG in suspected LF patient and normal control sera was performed as previously outlined by Grove et al. . IgM bin® blood chemistry analyzer  and Comprehensive Metabolic Reagent Discs, as per manufacturer's recommendations.The kinetics of fourteen serum analytes were analyzed with a Piccolo® benchtop cytometer  and an eBioscience FlowCytomix Human Th1/Th2 11-plex Kit . Additionally, VEGF-A, CRP, RANTES, IFN-α, and CD40L simplex kits were multiplexed for analysis of additional ligands. Serum aliquots collected and frozen throughout the experimental timeline were analyzed concurrently at the end of the study.Profiles of eleven serum cytokines were analyzed with an Accuri C6All serum samples were tested for LASV-specific Ag and IgM and IgG antibodies by ELISA, as outlined above. ReLASV NP was serially diluted and used to generate a standard curve in Ag-capture ELISA and LFI formats. Sera from previously diagnosed LF patients were used as IgM and IgG Ab-capture ELISA calibrators. As discussed in detail herein, patients who presented to the KGH LFW with a febrile illness were assessed by the following criteria: Patients were considered to have acute LF if a reaction above background levels developed on reLASV LFI modules and/or LASV Ag-capture ELISA, and/or LASV-specific RT-PCR generated a GPC gene-specific amplicon using oligonucleotides previously described by Olschläger et al. . SubjectPatients were assigned to one of five groups on the basis of LASV Ag status, IgM and IgG profiles, and outcome. Group assignment was largely based on real-time data at the time of testing or admission to the KGH, and in a few cases the course of illness was followed into early convalescence ,13. The th percentile obtained with a panel of sera from U.S. (USN) and Sierra Leonean donors without detectable LASV Ag, IgM, and IgG titers. Cytokine levels were calculated by applying curve fitting techniques to data generated with quantified standards for each analyte.ELISA data were plotted as mean ± SD, where each mean was based on two replicates, and error bars were used to represent the standard deviations. Limits of detection and quantitation of LASV-specific IgM were based on the upper 95p < 0.05.Box plots of IgM and IgG serum responses were generated for seven comparison groups: USN, MOY NHS, BOM NHS, LF FU, LF NF, LF F, and NL FI IgM+. Box plots of serum responses for IgM and IgG profiles were generated using the Vertex42 Microsoft Excel template . The Krup < 0.01). Similarly, Ag+ patients with no IgM upon admission were 5.36 times more likely to die than those who presented with neither Ag nor IgM titers (p < 0.01). We found no statistical difference between patients who had the same Ag status, again, irrespective of IgM. Both Ag+ groups  were nearly equally likely to die (p = 0.83), while both Ag- groups  where similarly likely to live (p = 0.61). IgM status, therefore, does not appear to impact survival outcome. Only 5 patients of this large cohort have presented to the KGH LFW with an Ag+ IgM- IgG+ profile: Four patients survived and one succumbed.Survival data from a database comprised of 1,909 suspected LF patients who were tested for LASV Ag and IgM at the KGH LFL from 2007 - 2011 is summarized in Table p < 0.01; Figure LASV NP Ag levels were measured in the serum of suspected LF patients by LFI, ELISA, PCR, or a combination of the three methods. Quantitative LASV NP Ag-capture ELISA was used to quantify levels of NP in LF patients. At the time of admission NP Ag levels between eventual fatal and non-fatal LF patients were statistically different , suggesting that IgM does not subside rapidly following the rise of IgG titers in convalescence . A moderate to high level of IgG was recorded in all follow-up sera , surviving LF patients (LF FU), acute fatal and nonfatal LF patients, and febrile LASV Ag-IgM+ subjects Figure . Additioe Figure . Similara Figure , 3B.Kenema district is a highly endemic LF region of Sierra Leone; therefore, collecting a representative sample population of Sierra Leonean normal controls in Kenema with low exposure to LASV was not possible. Instead, a panel of 101 sera samples was collected in April 2010 from individuals in the Southwestern province of Moyamba, described in the literature as a non-endemic region for LF ,16-23, fp < 0.001; Figure p < 0.001) but they did not differ from Bombali donors  and LF F (p < 0.001) patients at the time of diagnosis , calcium (Ca2+) corrected for albumin (ALB), alkaline phosphatase (ALP), alanine aminotransferase (ALT), and aspartate aminotransferase (AST)  levels in non-fatal and fatal LF were significantly higher than normal after correcting for albumin levels  -10, IL-8, IL-6, macrophage inflammatory protein 1 beta (MIP-1β) Figure , blood u) Figure  in LF pa) Figure , IL-4, a) Figure . Calciums Figure . The moss Figure . The LF 2+ levels . Alternatively, elevated LASV-specific IgM has served as a surrogate marker of a recent infection when LASV Ag could no longer be detected . With liBecause Kenema is historically endemic for LASV, we looked to the Northeastern and Southwestern districts of Bombali and Moyamba, respectively, to collect a panel of normal Sierra Leonean serum. These districts lie within reportedly non-endemic areas so exposure to LASV should be low. The donors from these two regions reported normal health at the time of blood draw without febrile episodes in the recent past, and had not travelled to the Eastern provinces where LF is endemic. Contrary to our expectations, a significant percentage in each population had LASV-specific IgM and IgG titers indicating a past infection with LF. Our findings challenged past reports claiming that LF is highly endemic primarily in the Eastern districts of Sierra Leone, and is largely absent in the country's Northern and Southern regions . Additionally, we found that positive LASV IgM seropositivity is not a reliable marker of acute LF base on the adjusted odds ratio of 1.13 in Ag-IgM+ (N = 171) versus Ag-IgM- (N = 244) in suspected LF patients , suggesting that IgM-producing cells have remained largely obscure and underappreciated in the characterization of arenaviral infections . AdditioIn the Ag positive subset of patients, remarkable differences were noted in cytokine and metabolite levels that could be used as early prognosticators in LF. Our results have confirmed historical reports demonstrating significant hepatic and renal dysfunction in LF, namely the high levels of ALP, ALT, and AST -39. HoweOur analysis of a nonfatal non-Lassa febrile illness (NF NL FI) study group revealed levels of IL-8 similar to those in the LF NF and LF F groups, despite observing increased levels of the inflammatory mediator in some subjects Figure . The onl2, Ca2+, RANTES, and CRP levels provide a statistical basis for poor prognosis. Two recent extensively-characterized reports of hemorrhagic LF in Sierra Leone with positive outcome presented to the KGH LFW with AST > 2000 U/mL and low levels of IL-6, -8, and in one case elevated IL-10 [Together, these data indicate that upon admission to the hospital with suspicion of LF, a profile of low to moderate IL-6, -8, -10, MIP-1β, CD40L, BUN, ALP, ALT, and AST levels predict a positive outcome following treatment with a full regimen of ribavirin, fluids management, antibiotics, and other appropriate medical intervention. Conversely, AST levels greater than 2000 U/mL are almost always indicative of a poor survival outcome. In addition to high AST, combined elevated IL-6, -8, -10, BUN, ALP, ALT, and reduced tCOed IL-10 ,12. BaseLimitations of this study include lack of randomization, limited number of fatal Lassa cases, potential patient by treatment interaction, and the limited duration of the study. Random assignment of subjects to comparison groups was not possible due to the uncontrollable nature of the outcome, and random selection of patients was impractical due to the limited number of fatal Lassa cases. As a result, some of the results that we observed may be due to inherent characteristics of our study subjects. This is perhaps most evident in the 13 normal donors from Bombali that registered greater than 90% IgG reactivity to LASV antigens. It is important to note that these limited studies were not designed to ascertain levels of IgM and IgG seroprevalence in Sierra Leonean populations. Instead, through the continuous analysis of incoming sera from patients and random collection of normal samples in two districts outside historically endemic regions, it was established that LASV infections in humans might be more prevalent across Sierra Leone than previously reported. In the case of Bombali donors we may have collected sera from a cluster of individuals who may have had an unknown exposure bias to LASV, thus registering high levels of IgG (and possibly IgM) to viral antigens. We suspect our study subjects are more likely to have multiple exposures to LASV than subjects from previous studies due to the increasing prevalence of the disease. Due to the small sample sizes for each of the comparison groups, we were unable to adjust for confounding variables, which makes the generalization of these findings inappropriate, particularly for those outside of Sierra Leone. Although all of the patients in this study were subjected to the same treatment protocol, it is unknown whether the treatment was administered in a consistent manner and whether patients responded differently to the ribavirin treatment. A randomized trial on the effect of ribavirin would be beneficial to future studies on Lassa fever. It is worth noting that there is a temporal component for the outcomes investigated in this study that is not well understood.Due to our characterization of a prolonged IgM response in convalescent LF patients, high prevalence of IgM seropositive in healthy normal controls, and the failure of most IgM only suspected cases to display a dysregulated metabolic and inflammatory cytokine profile similar to LASV-specific Ag+ patients regardless of IgM status, we suggest that the traditional paradigm for diagnosis of acute LF in West Africa should be reconsidered and changed. Rather than diagnosing an Ag+ and/or IgM+ result as acute LF, only in the subset of patients displaying LASV viremia, as determined by LFI and Ag-capture ELISA, with confirmation by RT-PCR should be definitively categorize a patient as being acutely infected with LASV. Patients that presented with symptoms indicative of potential LF and who do not test positive for viremia by any of the three methods employed while presenting with IgM and/or IgG titers should not be categorized as acute LF. Unfortunately, ultimate diagnosis of the non LF febrile illness for these patients will often not be possible due to low resources and lack of diagnostics for additional suspected infectious agents. Though, the new prognostic immune correlates of LF identified in this study will allow the scientific community to better understand, monitor, and possibly treat and prevent the disease.This work was performed as partial fulfilment of Ph.D. dissertation requirements for Jessica N Grove.Conceived and designed the experiments: LMB, JNG, MLB, RFG. Performed the experiments: LMB, JNG, MLB, AG, MF, MM. Analyzed the data and critically reviewed the manuscript: LMB, MLB, JNG, JGS, DSG, RFG. Performed critical statistical analysis of the data: JGS. Wrote the manuscript: LMB, JNG, JGS, RFG. All authors read and approved the manuscript.Complete characteristics of study subjects analyzed for cytokines and clinical chemistry. An expanded set of groups was analyzed for age, gender, duration of illness, and major signs. Corresponding odds ratios are shown, and asterisks (*) indicate significance at the 5% level.Click here for fileMap of West Africa displaying calculated rates of LASV Ag, IgM, IgG, and dual antibody in sera samples obtained from Sierra Leonean Districts of Moyamba and Bombali. (A) Districts of Sierra Leone: the historically hyperendemic districts of Kenema and Kallahun are circled in blue, and the Northern and Southern districts of Bombali and Moyamba are underlined in red. A map outlining Sierra Leone's four provinces is shown in (B). The relative locations in Sierra Leone where panels of normal sera study samples were collected are boxed in red. Antigen and immunoglobulin rates for locations sampled in this study are outlined in insets. Numbers of sera analyzed from each region are noted (N). Serological evidence of LF has been reported in Senegal and Mali (denoted with solid blue circles), and outbreaks are commonly reported in endemic regions of Sierra Leone, Guinea, and Liberia (denoted with solid red circles). The relative sub-Saharan geographical boundary for LF is outlined by the thick transparent orange line dissecting Guinea and Southern Mali [http://commons.wikimedia.org/wiki/Atlas_of_Sierra_Leone; C. Google maps.ern Mali . Source Click here for file


Risk for food induced anaphylaxis appears to be increasing with significant impact on children, parents and family life. Families need to understand how to avoid the allergen and recognize and respond to reactions. Safety measures and risk must be balanced to ensure the child and family live well with the allergy. We developed and piloted an education program for parents of children <6 years old recently diagnosed with a severe food allergy.• Literature review• Creation of program objectives and outline• Consultation with health care experts, parent representatives of food allergy organizations and an education specialist• Development of program content and process• Feedback from reviewers• Piloted Program: participant pre-assessment, small group sessions, participant feedback post program™ technology, iclickers®, discussion, video clips, skill training and problem-solving• We developed a small group, 2 session, interactive program using SMARTBoard• 43 families registered• 29 (67%) families completed • Parental burden & self-efficacy pre-assessment indicated concerns about activities, communication and allergic reactions• Auto-injector pre-assessment – 48 demonstrations observed; 73% did not complete all steps correctly• 32 (73%) people completing the program believed 2 sessions were sufficientOur pilot suggests this interactive, small group program is a useful resource for families learning how to live with a serious food allergy. We identified activities and topics requiring adjustment and obtained feedback to help improve future sessions. Follow up with families will be important for further evaluation.


The literature on simulated or standardized patient (SP) methodology is expanding. However, at the level of the program, there are several gaps in the literature. We seek to fill this gap through documenting experiences from four programs in Australia, Canada, Switzerland and the United Kingdom. We focused on challenges in SP methodology, faculty, organisational structure and quality assurance.We used a multiple case study method with cross-case synthesis. Over eighteen months during a series of informal and formal interactions (focused meetings and conference presentations) we documented key characteristics of programs and drew on secondary document sources.Although programs shared challenges in SP methodology they also experienced differences. Key challenges common to programs included systematic quality assurance and the opportunity for research. There were differences in the terminology used to describe SPs, in their recruitment and training. Other differences reflected local conditions and demands in organisational structure, funding relationships with the host institution and national trends, especially in assessments.This international case study reveals similarities and differences in SP methodology. Programs were highly contextualised and have emerged in response to local, institutional, profession/discipline and national conditions. Broader trends in healthcare education have also influenced development. Each of the programs experienced challenges in the same themes but the nature of the challenges often varied widely. Simulation-based education is expanding rapidly in medical and other health professional curricula. In the United Kingdom (UK), simulation was recently identified by the Chief Medical Officer as one of five significant challenges for health services in the next decade . The driIn this paper, we examine SP programs drawing examples from Australia, Canada, Switzerland and the United Kingdom (UK). We use the terms 'simulated' and 'standardised' patient (SP) to describe a person trained to portray a patient in a clinical scenario for educational purposes. The SP may also provide feedback to students, trainees and clinicians on their performance. In Australia and the UK, 'simulated patient' is usually a generic term where 'standardised patient' refers to actors trained to reproduce an equivalent performance for students in high stakes assessments . In CanaSPs have potential to be the highest fidelity 'simulator' and are well established in most undergraduate medical programs ,10. TheiThere are several reviews on different facets of SP methodology ,22,23, v1. What are key challenges associated with SPs in SP programs?2. What are key challenges for faculty in SP programs?3. What are key challenges in organisational structure of SP programs?4. What are key challenges of quality assurance in SP programs?We adopted a multiple case study approach -32 suiteOur experiences with SP programs are summarised according to number of SPs, recruitment strategies, training programs, principal foci, funding models, pay, research output, future plans and challenges Table .The SP program at Gippsland Medical School was developed in 2008 to support graduate entry medical students in a new medical school at Monash University. There are sixty to ninety students in each of the four years of the medical curriculum. Gippsland is situated in a rural environment and is characterised by high levels of community engagement. There are 45 SPs on the database. The program has academic leadership, is closely associated with a clinical skills curriculum theme and has technical and administrative support. SPs support the development of clinical skills in medical students with an emphasis on communication. They work almost exclusively with first-year students. SPs make a substantial contribution to implementation of skills assessments in the Objective Structured Clinical Examination (OSCE). The School has facilities designed to support teaching and learning in simulated clinical settings with opportunities for audiovisual review.As the largest (SPs = 592) and oldest, the SP program at the University of Toronto was started in 1984 in the Department of Family and Community Medicine (DFCM). As its activities expanded beyond family medicine, the program moved to the Wilson Centre for Research in Education. The program director reports to the Education Dean responsible for Continuing Education and Professional Development. SP teaching and assessment is thoroughly embedded in medical and health professional curricula. The cost-recovery program has eighteen full-time staff who manage academic and business activities. There have been enormous changes in the program - from the initial typed SP roles kept in a single filing cabinet and hand-entered accounts in a small black ledger the program has evolved to web-based training materials and an electronic database to manage over 500 registrants. SPs are employees of the University and classified as casual members of the United Steelworkers of America (USWA). Exponential growth during the 1990s was largely in response to the performance-based component of Canadian national licensing examinations in medicine, pharmacy and physiotherapy. The focus of the program has been teaching and learning clinical skills with an emphasis on communication behaviours. SP-based activities have expanded to include standardised caregivers/relatives, standardised students for faculty development, standardised parties in dispute for conflict resolution and standardised health professionals for inter-professional and team training.The SP program of HECVSanté was developed in 2009 and is located in the Unit of Educational Innovation. The SP program supports activities in four faculties - nursing, midwifery, physiotherapy and radiology technology. The program has an academic lead, an SP trainer (50%) and an administrator (20%) who work closely with the clinical skills centre. The database has 38 SPs. Each course has 25 to 38 students per year. SPs support the acquisition of clinical skills with an emphasis on communication. SP feedback to students plays a critical role in the educative process. The SP program has a strong interprofessional orientation.At Imperial College, the SP program evolved in 1998 with the creation of a Faculty of Medicine, an amalgamation of three established undergraduate medical schools together with research and other institutes in central London. The College graduates approximately 350 students each year. There are 260 SPs on the Imperial database. SPs work throughout the medical curriculum for teaching and assessment in a range of sessions on communication, general practice, patient safety and ethics. Although there is one SP program  located in the Department of Surgery and Cancer, there are several databases across the College. Similarly, there are several administrators supporting local needs with one overall academic lead.Table Many challenges emanated from SPs and the nature of their work. We discuss these according to recruitment, categories of SPs and performance and training.Challenges vary between programs with under and oversubscription influencing recruitment strategies. At Toronto there are 153 applicants awaiting interviews. At Imperial there is a waiting list to join the SP program while Gippsland and Lausanne are undersubscribed. Criteria for selection to SP programs are intentionally broad at Gippsland and Imperial. That is, SPs need to be interested, reliable and have an ability to retain information. After expressing interest, SPs at Gippsland are invited to a training session in which the methodology is outlined and demonstrated. While some participants withdraw at this point, the remainder stay on the database and are contacted when a session is scheduled. Personal and program referral  are the most common methods for recruitment at Imperial. In collaboration with other medical schools, Imperial offer recruitment and training sessions enabling SPs to demonstrate their role-play and feedback skills before joining the program. At Toronto, applicants are put through a rigorous screening and selection process that involves a large group orientation, followed by interview with at least two SP representatives. At Lausanne, SPs are also screened. After an initial phone interview, the SP attends the centre where they are interviewed, complete a questionnaire addressing different facets of SP work including their reasons for participating and have an opportunity to demonstrate their role-playing skills. All SPs have a 'conditional period' before being admitted to the program.Substantial gaps exist in all four programs with respect to special populations  requiring targeted advertising or recruitment by referral.The programs have several categories of SPs summarised in Table The sessional nature of SP work means that under-performing SPs  may not be invited for further work. Although training is always considered as an option to improve performance, the nature of the performance deficit will determine the course of action. At Toronto and Lausanne, teachers working with SPs are asked to complete brief written evaluations on scenario realism, SP performance and quality of feedback. Further, processes have been developed to note areas of concern with reference to SP performance. If an extreme breach of professional behaviour occurs, the SP is released .All four programs provide training that outlines learning objectives for trainees, the schedule, expectations of the SP and an opportunity for reviewing and rehearsing roles. Sessions on feedback provide guidance to SPs on the preferred format and process. Feedback varies according to the session goals and may include the use of structured protocols and rating forms. Feedback may be in-person and immediately after the role-play or videotaped for later review by the trainee. Training sometimes includes tutors with whom the SPs will be working but this is often difficult to schedule. Training for assessments includes examination protocols , expected trainee standards, rehearsal and calibration of performance.At Gippsland, SP training consists of generic programs that introduce the concept of SP-based education. These are offered up to twice annually to people who have expressed interest in being an SP. At Toronto, with its established cohort of SPs, the program has developed an annual professional development day which offers a menu of workshops on a variety of topics from which attendees (~200) can choose.We define faculty as all staff associated with SP programs - administrators, educators, clinicians and academics. A key challenge for all four programs is faculty development. That is, supporting faculty in further developing expertise in their roles.At Gippsland, Imperial and Lausanne, the SP program leads have academic appointments. They also have responsibilities outside the SP program as communication, clinical and/or education specialists. The leads provide training to SPs and tutors and share responsibility for SP role development and curriculum design. Research activity is expected and is perceived to be fundamental to success. Faculty development for academic staff is supported through attendance at conferences and other professional meetings. Tutors are offered focused training on working with SPs.At Imperial and Toronto, as part of quality assurance, a set of responsibilities for all those involved in SP work was developed through stakeholder consultation . The docHistorically, the Toronto program has been considered a 'service' entity although clearly it has become an integral part of the academic enterprise at the University. A project manager/SP trainer takes charge of a given course or assignment. Although the SP program is working toward full faculty appointments, this process is complicated by the union presence. Research activities and attendance at international conferences are strongly encouraged.The challenges associated with organisational structure varied according to scale of the program. The relationship of the program to the host institution is critical together with management and leadership.At Gippsland and Lausanne, the SP program's relationship with the host institution is very clear. The program exists to support trainees in the school/faculty. At Imperial, the SP program resides in one department although it works across the Faculty of Medicine. Again, it exists largely to support the delivery of the medical curriculum. At Toronto, the program operates as a business with a cost-recovery funding model based on fee for service. Although the program started in medical education, it now works across several faculties and outside healthcare. The program charges higher rates for private  enterprises, which partially underwrites university projects.At Gippsland, the clinical skills team provide leadership. The medical school offers administrative support. Academic activities include curriculum development, SP training program development, delivery and research. Administration support activities include maintenance of a database, recruitment and booking of SPs, preparing rooms and clinical skills equipment, audiovisual management, arranging payment, ensuring human resource compliance and copying program materials. As a relatively new program there is an opportunity to implement robust structures and processes for SP program management .At Toronto, the director, who is also the professional manager, oversees the program. There are three associate directors with portfolios of research, academic and business, a manager of SP relations and program operations, a systems manager, two business administrative officers, a digital media specialist, and nine faculty who function as project managers, SP educators, session leaders and SP trainers. All employees with the exception of the director are classified as Union members (USWA). This is an important point of difference with the other programs where union membership is not compulsory.At Lausanne, the SP program has a manager and academic leader both of whom work closely with discipline-specific teachers to develop relevant SP-based activities. The academic lead has responsibility for the expansion of the program and research. Administration activities include development and maintenance of a database, copying materials, establishing contracts, arranging payment, booking rooms, and organising evaluations.At Imperial, there is an SP academic lead who has responsibility for the program across the medical curriculum. This allows close ties with academics in several departments enabling a multi-disciplinary approach to writing scenarios. Administrators manage the SP database and all human resource support. The recent formation of the Imperial Academic Health Science Centre through the merging of two West London Hospital Trusts and Imperial College has added an extra level of complexity to the organisation, but has encouraged collaboration between academic and clinical teams.Funding models play a significant role in SP programs. The global financial crisis has had significant impact. The teaching and assessment activities at Gippsland, Imperial and Lausanne are funded through university budgets allocated to the curriculum. SP payments fall within this budget as do staff who support the program. Research projects and educational activities outside the curriculum are paid independently by the funding source. At Toronto, the cost recovery model has been in place since the outset of the program. There is a fee schedule that includes a mark up to cover Toronto benefits paid to SPs and an "access fee" of 25% covering the salaries of full-time staff and all operating expenses. SPs are provided to any programs within and outside of the University for which fees are paid.SPs at Gippsland sign one-year contracts prior to undertaking work. There is one rate of pay for all SP activities . Pay forms are completed at the time of the session with a minimum number of three hours for each session.At Imperial and Lausanne, SPs are employed on a sessional basis for specific teaching, assessment and research. Fees vary depending on the purpose of the session. At Imperial, SPs do not sign a contract and are paid according to an hourly rate, with a minimum payment of three hours for a session. Most SPs are registered as self-employed, and are required to provide proof of self-employment. Because London has several medical schools geographically close together, many of the SPs also work regularly for other medical schools.At Toronto, SPs do not sign contracts. However, they are required to read and acknowledge a letter setting out responsibilities and expectations of the SP and the program. SPs are classified as casual employees and are therefore members of the USWA. Fees vary depending on the complexity of the session with a minimum payment of two hours.SP databases contain information about SPs that enable appropriate casting. Examples of content contained in the databases are included in Table At Imperial and Lausanne, the database is currently in Microsoft Excel, with plans to move to a web-based system to increase flexibility. At Imperial, SPs are sourced and booked electronically. The large scale of examinations (with some exams occurring simultaneously over multiple sites) has facilitated change with more electronic systems used for confirmation of bookings. However, this program requires further development. Currently only the program manager and administrators have access to the database, acting as gatekeepers to other interested parties.Toronto faces several challenges in data management and has survived several phases of re-design. Financial records and payroll must be compatible with the larger university system. The main database and some supplementary databases unique to outside clients are contained in Microsoft Access providing complete information on every SP. Although progress has been made towards booking and communicating with SPs electronically, not all SPs are computer literate. The program website will become the forum for all SP communication.All SP programs recognised the need for quality assurance at the level of the program. This includes setting standards for recruitment, training and feedback processes. Gippsland and Lausanne implemented processes to capture session evaluations. This was considered especially important as they are relatively new programs with evolving resources. Their scale also permitted collection and collation of data. Toronto and Imperial are more established and have targeted session evaluations. Each program had informal measures in place to identify under-performing SPs. Faculty are encouraged to report any concerns to program leads who will decide how best to deal with the issue. Programs acknowledged the need to improve feedback to SPs on all aspects of their work. Although valued by program directors and SPs, feedback to SPs is often omitted because of time pressures and hourly rates of pay.Local , institutional , discipline/profession  and national  contexts have profoundly influenced the development of the SP programs. The four programs have emerged in different educational 'eras' and to meet different needs. Although highly contextualised, there are similarities between programs. These include their shared goal to provide high quality educational opportunities for trainees. Recent sharing of resources between programs has facilitated standard setting and perceived enrichment of programs. However, funding models constrain the extent to which resources can be freely shared.While each program faced similar challenges the nature and direction of challenges differed. For example, in synthesizing key challenges for SPs, recruitment proved an issue. Two programs had difficulty recruiting SPs (Gippsland and Lausanne) while two programs were oversubscribed . This led to different recruitment strategies and selection processes. However, all programs were challenged by recruitment of special populations . Similarly, with performance and training, there were differences in the nature of challenges. The amount and type of training was strongly influenced by program resources and the volume of SP work.In the synthesis of key challenges for faculty in SP programs, faculty development was highly valued and well supported for academic leads but there was less evidence of development opportunities for other faculty. For key challenges in the organisational structure of SP programs, clarity in the relationship with the host institution was critical and influenced several facets of the programs. The programs differed in relation to the type of leadership. That is, academic or professional management. The nature of the leadership in part reflected the funding models for each program. In this case study, only Toronto had a cost-recovery model. That is, they are self-funded charging for all services. In contrast, the three other programs were funded through university curriculum budgets. Additional differences between programs related to the role of union membership. Again, only Toronto had a union presence.We hypothesise that the program 'culture' is influenced by their core business and scale. For example, the 'program' at Gippsland does not have an identity independent of its host institution while the program at Toronto has an international profile. The culture of the SP program at Toronto is highly 'professional'. The program sustains many SPs in work on a weekly basis. In contrast, at Gippsland and Lausanne no individual SP works on a weekly basis. This reduces opportunities for development and advancement of the methodology because there are fewer opportunities to practice, Further, undersubscribed programs are more likely to be challenged by quality assurance issues associated with the limited pool of SPs. It is also apparent that SP programs take time to 'mature' as SPs develop expertise through practice, feedback and mentoring  and are In this analysis, national assessments and scale are interrelated. In our case study, only Canada has national health professional exams at the undergraduate level. This strongly influenced the size and focus of SP programs. Identity was also influenced by the location of the program in the University - in a small medical school, as an independent SP program, in specialist education unit and in a surgical department.Terminology between SP programs varied and this created confusion and misunderstanding in cross-institutional comparisons. Notable differences in programs include their longevity, the consequent level of experience of SPs, numbers of registrants, funding models, pay rates, research profile and challenges. Research activity was partially influenced by funding models. However, local champions and expertise in educational research was also important.The SP programs at Gippsland, Imperial and Toronto support the development of patient-centred communication and other professional skills in medical students and doctors. Lausanne differs in its target group working almost exclusively across professional disciplines. Toronto also works extensively across health professional groups. Imperial and Toronto cater to large numbers of trainees. In each program, strong academic and administrative leadership was considered critical for embedding SP-based education in curricula and for seeking new opportunities.The literature offers little guidance on recruitment although qualities of SPs are regularly reported ,24. QualThe Gippsland and Imperial programs are co-located with clinical skills simulation centres. Broader trends in the 'accreditation of simulation centres' are likely to impact SP programs. SPs in these programs were perceived as core to such centres rather than separate.SP programs need to be responsive to local needs. Although larger and more established programs can offer a suite of educational activities, they were also constrained by instructional and regulatory issues. They have the ability to offer large-scale examinations while smaller programs focused on meeting specific local needs. The scale of the program seems to create different types of challenges.The authors were all involved in the research process and so it is possible that responses were biased. However, the extended period over which the study occurred and the multiple authors provided repeated opportunities for validation. Further, it is possible that as a self-selected group of academics sharing a similar philosophy to SP methodology there is bias in our reporting. The cases do not represent all types of SP programs. We acknowledge the highly contextual nature of each SP program and like much qualitative research we do not make claims for generalisability.Using a case study approach we have offered insight to four SP programs in different parts of the world. We specifically examined key challenges in SP methodology, of faculty in SP programs, of organisational structure and quality assurance. While each program faced similar challenges the nature and direction of challenges differed. For example, programs were challenged by SP recruitment with over and under subscription, which in turn led to different recruitment strategies and selection processes.As simulation-based education expands we hope our experiences may be valuable for faculty entering this field and for those already established, to promote reflection on their programs and to plan future activities. We do not make recommendations about 'best practice' because our experiences demonstrated that each SP program was highly contextualised. We hope others will take from each program what they think is appropriate for their own. We believe our own practices have improved as a consequence of sharing experiences in the process of preparing this paper. A concluding message is the need for continued efforts in establishing an evidence-base of SP methodology.The authors declare that they have no competing interests.DN and DT developed the concept. All authors contributed to the provision of data for the case study. DN drafted the first manuscript. All authors contributed to the writing of the manuscript. All authors have read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1472-6920/11/69/prepub


Significant improvements were seen in all measures of PA, self-concept, and anxiety. CHW-SB, a government-funded program, is the first obesity-treatment program to be evaluated in Canada. While short-term evaluation revealed significant improvements in adiposity, PA, and psychological measures, the lack of full follow-up is a limitation in interpreting the clinical effectiveness of this program, as drop-out may be associated with lack of success in meeting program goals. These data also emphasize the need for ongoing evaluation to assess the long-term implications of this unique program and ultimately optimize utilization of governmental resources.The objective was to conduct a program evaluation of the Centre for Healthy Weights—Shapedown BC (CHW-SB), a family-centered, multidisciplinary program for obese children, by assessing the change in weight trajectories from program intake to completion. Secondary outcomes included changes in clinical, biochemical and psychological parameters, and in physical activity (PA) levels. The CHW-SB program was evaluated over 10 weeks. Data collection included anthropometric, metabolic, PA and psychological measures. Longitudinal mixed effects regression was performed to evaluate weight change from Phase 1 (before program on waitlist) to Phase 2 (during program). 238 children <18 years of age were referred to the program of which 119 were eligible for participation. There was a significant decrease in weight trajectory in children following program entry. Participants experienced an average .89% monthly increase before program entry, compared to a .37% monthly decline afterwards, a drop of 1.26% ( Childhood obesity is a serious public health concern worldwide ,2,3. In Further to the growing body of literature showing increases in obesity prevalence, there are also compelling data demonstrating a positive relationship between obesity and risk for future chronic disease. Specifically, an elevated body mass index (BMI) in children greatly increases the likelihood of developing type 2 diabetes, hypertension, hyperlipidemia, nonalcoholic fatty liver disease, orthopedic complications and sleep apnea ,14,15,16It is estimated that as many as 30% of obese adolescents have the metabolic syndrome ; a conceCurrently, options for long-term management of obesity include programs targeting behavior surrounding diet and exercise, pharmacological agents, and bariatric surgical approaches. In the pediatric population, lifestyle modification interventions should be the first line of treatment when dealing with this problem, given the invasiveness of other approaches . Such inLifestyle and behavior modification approaches have been found to be efficacious to treat childhood obesity, at least in the short-term ,26,27. RThe objective of this study was to evaluate the Centre for Healthy Weights—Shapedown BC (CHW-SB) familial intervention program targeted at overweight and obese children by assessing the change in weight trajectories from program intake date to program completion date. We hypothesized that the CHW-SB program would decrease the slope of the weight gain trajectory in children over the course of the 10-week program. Our secondary outcomes included changes in clinical, biochemical and psychological parameters, as well as changes in physical activity levels in program participants.The protocol was approved by both the University of British Columbia Clinical Research Ethics Boards and the Children’s & Women’s Research Review Committee. Parents provided informed written consent and children provided assent. This study was a registered clinical trial (NCT00564798) designed as a prospective program evaluation of a cohort of participants where children were assessed from date of intake to the CHW-SB program (described in detail below) until date of completion of the 10-week program. Participants waited a median of 87 days (range: 12 to 272) to participate in the CHW-SB program. They were measured at the intake visit and again at the time of starting the program, which made it possible to assess weight trajectories changes before the program intervention compared to during the program. By taking advantage of this practical situation, we were able to obtain a waitlist control group for comparison purposes without delaying access to treatment.Shapedown program developed in the United States as a family-centered, multidisciplinary program that includes cognitive, behavioral, affective and interactional techniques for obese children and their families. In a pilot evaluation conducted by Mellin et al., Shapedown participants demonstrated improvements in weight, self-esteem, weight-management knowledge and depression h Curves . Waist ch Curves . In thiswas used .Laboratory samples were obtained after at least 8 hours of fasting. Fasting glucose and fasting insulin were obtained at intake and 10 weeks and cholesterol, high-density lipoprotein cholesterol (HDL-c), low-density lipoprotein cholesterol (LDL-c) and triglycerides were obtained at intake only. Insulin resistance was calculated using the homeostasis model assessment of insulin resistance (HOMA-IR): [Fasting glucose (mmol/L) × (fasting insulin (pmol/L)/7)]/22.5 . The conth percentile for age and sex [th percentile for age, sex and height and impaired fasting glucose ≥ 5.6 mmol/L (modified to reflect the 2007 American Diabetes Association definition of IFG) [A pediatric definition of the metabolic syndrome modified from the Third National Cholesterol Education Program (NCEP III) , compris and sex , TG ≥ 1. of IFG)  was usedet al. [Ainsworth Compendium of Physical Activity [The physical activity questionnaire (PAQ), modified from Crocker et al.  was usedet al. ,42 and iActivity .The Child Behavior Checklist (CBC)  was comp® 10.1 software  package and PASW® Statistics Version 18 . All continuous variables were expressed as mean ± SD and paired-samples t-tests were used to assess changes in these variables over the course of the program. Where the data was not normally distributed, a Wilcoxon signed-rank test was used in place of a t-test.The analysis was done using STATAz-score since height was only measured at intake, baseline, and evaluation. To test change in slope as a result of participating in the CHW-SB program, the weight measurements were divided into two phases. Phase 1 (intake to baseline) included weight change that occurred while the participants were on the program waitlist. Phase 2  included weight change that occurred during the 10-week CHW-SB program. Independent variables were sex, age at program entry, phase, and days elapsed from program entry . Trajectory slopes for phases 1 and 2 were compared and served to assess the effect of the CHW-SB program, where a significant change in slope was indicative of a program effect. Slopes are reported as monthly percentage growth for ease of interpretation. A p-value <0.01 was considered statistically significant to adjust for multiple comparisons.Longitudinal mixed effects regression analysis  was perfOf the 214 children referred to the CHW-SB program, 42.2% were referred by family physicians, 40.2% by general pediatricians, and 17.6% by pediatric sub-specialists. Individuals declined participation due to geographic location or motivation and readiness barriers. The flow of subjects through the study is presented in 2, and the mean BMI z-score was 2.3 ± 0.33. The mean waist circumference was 98.5 ± 15.70 cm, and 97.5% of the children had a waist circumference ≥90th percentile. The prevalence of the metabolic syndrome and its individual components are presented in Baseline characteristics of the program participants are shown in th percentile).In addition, psychological data collected at intake revealed that 49.1% and 19.1% of participants, respectively, presented with Internalizing and Externalizing problems that fell within the Clinical range . Entry into the program was associated with a change from weight gain to weight loss. z-score,  and in mean waist circumference  over the 10 weeks. Fasting insulin decreased from 137 ± 94.8 to 121 ± 83.4 (p < 0.001). There was also a trend in reduction of HOMA-IR ; however, this was not statistically significant. There was no difference in mean fasting glucose from intake to program evaluation. There were significant decreases in mean BMI p < 0.0001).Changes in self-reported physical activity as measured by the PAQ over the course of the 10-week program are presented in p < 0.001). The mean BYI-II T-Score for anxiety significantly decreased from 49.6 ± 8.70 to 45.7 ± 11.80 (p = 0.001). Mean BYI-II T-Scores for depression were 47.2 ± 8.31 and 46.2 ± 9.35 before and after the program, respectively, and were not statistically different (p = 0.21).Mean BYI-II T-Score for Self Concept significantly improved from 46.4 ± 7.86 to 51.5 ± 9.56  to Phase 2 . Furthermore, longitudinal mixed effects regression analysis revealed that more days spent in the program resulted in a greater reduction in weight trajectory. In addition to these encouraging changes, when BMI was standardized for the child’s age and sex by conversion to a  to rise .et al. also evaluated a family-centered, weight management program for overweight children [z-scores during the 12-week program compared to before the program started. Furthermore, this study also noted improvements in emotional well-being as measured by a Child Health Questionnaire. Savoye and colleagues [Bright Bodies for overweight children and found that after 12 months, participants gained significantly less weight during the program than controls. Like CHW-SB, this program also utilized a behaviour modification component, exercise component, and a nutrition education component focusing on a non-diet approach. In addition, the program evaluated by Savoye et al. [z-score was found to decrease by 1.2% [et al. [versus 5-year follow-up: 2.74 ± 0.85). It will be important to continue to evaluate CHW-SB program to assess whether the positive results reported herein can be sustained over the long-term.At least 17 other pediatric obesity intervention programs similar to the CHW-SB program exist in Canada; however, to our knowledge, formal evaluation of these programs has not yet been reported . In the children . Like thlleagues  also impe et al.  found th by 1.2% . In a lo [et al.  found thzBMI seen in CHW-SB participants came improvements in some of the metabolic syndrome components. Waist circumference decreased considerably over the relatively short evaluation time period of 10 weeks. This reduction is clinically relevant, since it has previously been shown that abdominal adiposity is a serious risk factor for cardiovascular disease [Along with improvements in weight and  disease . Further disease ,56 have th percentile [et al., it was found that in addition to a decrease in BMI z-score, there was a significant improvement in cardiorespiratory fitness; however, unlike CHW-SB, this program found a non-significant (p = 0.08) improvement in hours of moderate physical activity per week [The CHW-SB program also resulted in dramatic increases in physical activity. MET*minutes of exercise and moderate physical activity both increased by almost 50% and minutes of physical inactivity decreased by 38% over the 10-week program. In Virginia, TEENS was developed as a weight management program for adolescents with BMI ≥ 95rcentile . Like CHper week .Mi Piace Piacermi, where participants’ emotional and social behaviours improved [Shapedown program where after 15 months, a large improvement in self-esteem was observed both in a general population of overweight children and in a sub-population of obese children with type 2 diabetes [In addition to the significant improvement in adiposity, metabolic, and physical activity profiles observed in participants, the CHW-SB program also resulted in both clinically significant reductions in self- reported anxiety and increases in self-concept (self-esteem) as measured on the Beck Youth Inventories Second Edition. Our results are consistent with both the results of the Kids N Fitness where, after 12 weeks, participants’ emotional well-being and behaviour improved  and withimproved . As welldiabetes ,30. Thesdiabetes ,58,59.While other North-American weight management programs for overweight children have been successful in the past, the multi-disciplinary, family-centered approach, coupled with group therapy and a comprehensive medical evaluation, makes the CHW-SB program unique . In conjThe results of this study must be interpreted within its limitations. The main limitation of this study was that we did not have a standard control group. Nonetheless, we were able to utilize the waiting period before the program began to use each child’s data from baseline to intake as their own “control” for their changes during the program. Having a naturalistic comparison for weight changes that is appropriately matched for age and sex is a strength of this study. The lack of full follow-up is also a limitation in interpreting the effectiveness of this program, as drop-out may be associated with lack of success in meeting program goals. The longitudinal analysis ameliorates this issue but does not avoid it completely. The analyses of changes between visit 1 and visit 10 may reflect bias in the optimistic direction. Additionally, the PAQ only examined participants who attended >7 sessions; thus improvements in physical activity observed in our evaluation may be linked to attendance.Unfortunately, we were not able to assess whether the CHW-SB program decreased the prevalence of dyslipidemia and hypertension since these parameters were not measured at evaluation. It will be important that future program evaluation include analysis of these parameters to properly assess the programs influence on the metabolic syndrome. Furthermore, our evaluation did not include an assessment of nutrition or an objective assessment of physical activity. Both are important to include in subsequent evaluations to help us understand which behaviours are modified as a result of intervention. While we had positive results, they were of modest magnitude, and our evaluation did not include long-term follow-up. Our evaluation was limited because government funding for the CHW-SB program did not include the cost of program evaluation. Future program support should include means for long-term systematic evaluation to assess program effectiveness and ensure that tax-payer dollars are being spent appropriately. Finally, our participation rate of 71% is a strength as it is an improvement on participation rates of 63% reported in a weight intervention program of similar duration in children .CHW-SB, a government-funded program, is the first obesity treatment program to be evaluated in Canada. While short-term evaluation revealed significant improvements in adiposity, PA, and psychological measures, these data emphasize the need for ongoing evaluation to assess the long-term implications of this unique program and ultimately optimize utilization of governmental resources.


Assistance from non-professional disaster volunteers  is essential for disaster victims to recover physically and rebuild their lives; however, disaster victims in some areas are reluctant to accept assistance from volunteers. This study explored factors that may influence collaborative activities between volunteers and victims of earthquake disasters.From July to September 2008, a self-reporting questionnaire survey was conducted with all 302 leaders of neighborhood associations in a city within Niigata Prefecture at the time of the Niigataken Chuetsu-oki Earthquake in 2007. Each factor was determined based on the Health Belief Model. Multiple regression analysis was conducted, using collaborative activities as the objective variable.From 261 valid responses received (response rate 86.4%), 41.3% of leaders collaborated with volunteers, and 60.2% of associations had residents who collaborated with volunteers. Collaboration with volunteers was significantly and positively related to perceived severity of an earthquake disaster  and neighborhood association activities during the earthquake disaster . A positive and marginally significant relation was found between such collaboration and sense of coherence within a community , social capital , and perceived benefits .Collaboration between disaster victims and volunteers during the response to an earthquake may require the preemptive estimation of damage by residents during normal times and the enhancement of neighborhood association activities during a disaster. For residents to have such estimation abilities, public institutions should provide information related to anticipated disaster damage and appropriate disaster prevention training and education. In addition, residents should create a disaster prevention map with other residents. Lastly, promoting neighborhood association activities may require the participation of many residents in disaster drills and education as well as a preemptive discussion of neighborhood activities during a disaster. The natural conditions of Japan, including its geographical position, geographical formations, and geology, mean it is prone to earthquake disasters. Japan is also left vulnerable to such disasters due to its aging population, weakening of community ties, overcrowding of cities, and depopulation of rural areas. In circumstances such as these, neighborhood associations, recognized as “groups formed by neighborhood ties” During previous earthquake disasters, neighborhood associations within towns in the disaster areas have played important roles in saving lives, evacuating residents, and providing living assistance immediately after the earthquake. Since the functioning capacity of these neighborhood associations is far from sufficient, they respond to disasters with the help of government, businesses, schools, and disaster volunteers. Unlike the government's response to standard and common needs which is characterized by limited personnel and points of assistance, disaster volunteers are capable of flexibly responding, in large numbers, to the diverse needs of victims. Their activities are an absolute necessity Disaster volunteers are classified from various perspectives. They can be classified according to their expertise, as either specialist disaster volunteers who possess professional skills, such as those found in the medical profession, or non-professional disaster volunteers who are average citizens with no particular professional skills and who implement support activities in the disaster areas Following the significant attention that the volunteer efforts after the Great Hanshin-Awaji Earthquake of 1995 attracted, it has now become common for large numbers of volunteers to rush to disaster sites and conduct relief activities immediately following disasters This study concerned the 6.6 magnitude Niigataken Chuetsu-oki Earthquake that occurred on July 16, 2007. All 302 leaders of neighborhood associations across an entire city in the disaster area in Niigata Prefecture at the time of the disaster were surveyed in July to September, 2008. A self-administered questionnaire was distributed to the leaders by mail. The leaders completed the questionnaire anonymously and returned it by mail.We regarded the leaders in each community as representatives of victims on the basis of the results of a survey conducted by the city office in the previous year. Accordingly, the neighborhood association leaders were chosen by election, rotation, or via a lottery among all residents. Furthermore, 92.9% of neighborhood association leaders routinely talked with residents about local problems such as the environment, disaster prevention, and crime prevention during normal times This study used the Health Belief Model (HBM), a behavior modification theory, to systematically analyze the factors that contributed to carrying out collaborative activities between victims and volunteers during the earthquake disaster. HBM is a model which assumes that a person's perception and belief will affect his or her health behavior The conceptual framework of collaboration activities when using HBM in this study was as follows . The perBefore conducting the present study, we visited the disaster site and conducted a small face to face unstructured pilot survey. Then, on the basis of the results, we examined and created the current survey items to reflect factors of the conceptual framework, which was based on HBM factors such as health actions, perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cues for action, sociopsychological variables, and structural variables. Collaborative activity with volunteers was designated as health action. Sociopsychological variables were the four factors of neighborhood association activities, social capital , sense of coherence  in the community, and individual SOC. Knowledge and experience were selected as structural variables. From the following survey items, 11 factors were generated. 1) Collaborative activity items examined initiatives for cooperation between neighborhood association leaders, residents, and volunteers, triggers for cooperative activity, as well as support for volunteer efforts by leaders and residents. 2) Perceived susceptibility items related to estimates for earthquakes. 3) Perceived severity items related to earthquake scenarios. 4) Perceived benefit items related to usefulness and outcomes. 5) Perceived barrier items related to feelings of resistance. 6) Cue to action items related to information. 7) Neighborhood association activity items related to the activities and circumstances of the town after the earthquake. Items on 8) SC and 9) SOC in the community were from the scale used in the extensive surveys carried out in the Aichi Gerontological Evaluation Study The study was conducted with approval from the Ethics Review Board of Hamamatsu University School of Medicine (No. 20-5).First, for each of the 11 factors, principle component analysis was conducted to aggregate 2–9 items into a single-factor score. Principal component analysis was used because it is generally appropriate for computing a total score from multiple variables. The analysis determines the weighting coefficient of each variable  so that the variance of composite variables is maximized Second, multiple regression analysis was conducted with collaborative activities as the objective variable and all other factors as explanatory variables. An adjusted standardized partial regression coefficient was calculated including explanatory variables of damage conditions and number of households as covariates. Associations were then examined. SPSS for Windows ver. 15.0  was used for all data analysis.There were 261 valid responses, for a valid response rate of 86.4%. Collaborative activities and each survey item are shown in As to perceived susceptibility to an earthquake before the disaster, 46.4% of respondents had anticipated a small earthquake. As to perceived severity, 37.6% predicted that an earthquake would affect their lives. With regard to perceived benefits, 68.2% had thought that collaborative activities with volunteers would be helpful in recovery efforts following a disaster. In terms of perceived barriers, 39.5% indicated reluctance in revealing personal information to volunteers, and as to cues to action, 90.8% had obtained information about volunteers from the media.During the earthquake disaster, 96.8% of neighborhood associations responded to address earthquake damage, and volunteers arrived in 58.6% of neighborhoods. Collaborative activities with volunteers were conducted by 41.8% of all neighborhood association leaders and 60.2% of neighborhoods had residents who performed such activities.Factor loadings for each factor item score are shown in This study found that leaders that had higher perceived severity of an earthquake disaster in normal times conducted more collaborative activities with volunteers. Given that perceived severity items concerned damage estimates, collaborative activities may have been influenced by pre-earthquake damage estimates considered by the leaders. Previously in October 2004, the 6.8 magnitude Niigata Prefecture Chuetsu Earthquake had struck in the region surveyed in this study. In a previous study, as actual cases have been shown to exert greater psychological influence than statistical figures Leaders may also have collaborated with volunteers after the earthquake because they knew the publicly reported extent of quantitative damage, and predicted that they themselves would suffer damage. In Japan, the Cabinet Office and local municipalities estimate total damage in earthquake scenarios, given the size of the quake, the number of collapsed buildings, the number of deaths, and the number of evacuees. Information about damage estimates are released on the Internet and in fliers and newsletters. Residents can get a general grasp of the risks of earthquakes for widespread residential districts. In recent years, hazard maps showing such risk information have been released to the public.However, a 2002 poll in Japan revealed that 68% of the people surveyed had never actually seen a hazard map In the present study, neighborhood associations more active in their response to the earthquake disaster were found to have carried out more collaborative activities with volunteers. Neighborhood association members live in the same community, help each other, work together to resolve issues, and have common interests In regard to the roles of the associations and circumstances of their members, it may be difficult for associations to manage the large number of issues they should respond to in times of disaster. Although all households are expected to join the association, participation rates have fallen recently, and members are growing older The present study found that more collaborative activities were conducted with volunteers when leaders have a stronger SOC in the community. SOC is a stress-coping ability, consisting of “comprehensibility”, “manageability”, and “meaningfulness” In the present study, there was a tendency toward more collaborative activities with volunteers the higher the SC was. Therefore, SC should be built for residents to collaborate with volunteers. Putnam defines SC as characteristics of societal organizations, namely “trust”, “social norms”, and “networks”, which can improve the effectiveness of society by facilitating collective action The present findings showed that the more the participants perceived the volunteer activities as being beneficial, specifically in terms of effectiveness and usefulness, the more they engaged in collaborative activities. In a previous survey, 72% of victims reported that volunteer activities at the time of the disaster contributed immensely to the response for recovery and reconstruction efforts, and 74% were extremely appreciative of volunteer activities There are several limitations to the present study. First, recall bias and lack of accuracy are possible since the survey was conducted a year after the earthquake disaster, on information before and during the disaster. It is extremely difficult to conduct a two-time survey on the same area before and after an earthquake, or in the early phase of an earthquake disaster, as earthquakes occur unexpectedly. This limitation is common to most disaster research. Second, the disaster area, and actions and thoughts of victims were understood solely from the responses of the neighborhood association leaders, in order to relieve victims of the burden of completing the survey. Although the leaders of the neighborhood associations had been selected from among neighbors, and because we had information on neighbors' opinions from past surveys, the actions and thoughts of all victims were not directly surveyed. Third, because the HBM was selected for this study, the survey items were not from existing scales, but were developed by the authors of the present study. Thus there may be some issues related to the validity and reliability of each item The strengths of the study include the quantified analysis of factors for collaborative activities between leaders, residents, and volunteers, and that it targeted all leaders of neighborhood associations of one city within an extensively damaged area. Furthermore, the findings will be a valuable resource for the development of future strategies and in earthquake disaster research because of the importance placed on the collaborative activities of people during disasters.In conclusion, collaborative activities with volunteers were significantly related to perceived severity during normal times and to neighborhood association activities during disaster times. Thus, collaboration of disaster victims with volunteers in response to earthquake disaster may require measures for residents to estimate possible damage and to enhance their response to the earthquake disaster in neighborhood association during normal times. For residents to have such estimation abilities, public institutions should provide information related to anticipated disaster damage and appropriate disaster drills and education. In addition, residents will be expected to collaborate in the creation of a disaster prevention map which shows hazards. Lastly, promoting neighborhood association activities may require the participation of many residents in disaster drills and education in normal time, as well as in discussion of neighborhood activities to be conducted during disaster times that includes the acceptance of aid from volunteers.Figure S1A conceptual framework leading to the collaborative activities using Health Belief Model. Becker et al.'s model was referred for the conceptual framework of the present study. The upper row shows the HBM factors reported by Becker et al. (TIFF)Click here for additional data file.Table S1The reliability  for each factor score.(XLS)Click here for additional data file.Table S2The criterion-related validity for each factor score.(XLS)Click here for additional data file.


The Disease Management Association of America identifies diabetes as one of the chronic conditions with the greatest potential for management. TRICARE Management Activity, which administers health care benefits for US military service personnel, retirees, and their dependents, created a disease management program for beneficiaries with diabetes. The objective of this study was to determine whether participation intensity and prior indication of uncontrolled diabetes were associated with health care use and costs for participants enrolled in TRICARE's diabetes management program.This ongoing, opt-out study used a quasi-experimental approach to assess program impact for beneficiaries  aged 18 to 64 living in the United States. Inclusion criteria were any diabetes-related emergency department visits or hospitalizations, more than 10 diabetes-related ambulatory visits, or more than twenty 30-day prescriptions for diabetes drugs in the previous year. Beginning in June 2007, all participants received educational mailings. Participants who agreed to receive a baseline telephone assessment and telephone counseling once per month in addition to educational mailings were considered active, and those who did not complete at least the baseline telephone assessment were considered passive. We categorized the diabetes status of each participant as "uncontrolled" or "controlled" on the basis of medical claims containing diagnosis codes for uncontrolled diabetes in the year preceding program eligibility. We compared observed outcomes to outcomes predicted in the absence of diabetes management. Prediction equations were based on regression analysis of medical claims for a historical control group  that in October 2004 met the eligibility criteria for TRICARE's program implemented June 2007. We conducted regression analysis comparing historical control group patient outcomes after October 2004 with these baseline characteristics.Per-person total annual medical savings for program participants, calculated as the difference between observed and predicted outcomes, averaged $783. Active participants had larger reductions in inpatient days and emergency department visits, larger increases in ambulatory visits, and larger increases in receiving retinal examinations, hemoglobin A1c tests, and urine microalbumin tests compared with passive participants. Participants with prior indication of uncontrolled diabetes had higher per-person total annual medical savings, larger reduction in inpatient days, and larger increases in ambulatory visits than did participants with controlled diabetes.Greater intensity of participation in TRICARE's diabetes management program was associated with lower medical costs and improved receipt of recommended testing. That patients who were categorized as having uncontrolled diabetes realized greater program benefits suggests diabetes management programs should consider indication of uncontrolled diabetes in their program candidate identification criteria. Disease management programs educate patients and teach them self-management skills that lead to more healthful lifestyle choices and appropriate use of health care services. These improvements can produce better health outcomes and reduced medical costs. The Disease Management Association of America describes type 2 diabetes as one of the chronic diseases best suited for disease management; most studies have found improved patient outcomes after participation in diabetes management programs -3.TRICARE Management Activity, the health care benefits administrator for US military service personnel, covers 9.4 million beneficiaries ; approximately 225,000 beneficiaries who are aged 18 to 64 years and ineligible for Medicare have been diagnosed with diabetes  visits or hospitalizations, more than 10 diabetes-related ambulatory visits, or more than twenty 30-day prescriptions for diabetes drugs.From June 2007 through September 2008, 37,370 patients were automatically selected for enrollment in this program; 11% opted out. Among program participants, approximately 25% chose to receive personalized telephone counseling. Services included a baseline assessment by telephone with a care manager (lasting 40-50 min); monthly telephone calls to educate patients and assess progress toward goals; educational materials ; and newsletters and online materials. These patients were categorized as "active" participants. The remaining 75% of patients, categorized as "passive" participants, received newsletters but chose not to receive personalized counseling. All patients could contact care managers by telephone if they had questions about their diabetes, and they could access Internet-based educational resources. Additional information about TRICARE's disease management program is available elsewhere .The voluntary, opt-out nature of this program, which based eligibility on high use of health care services, introduced 3 phenomena that we considered in the evaluation design. First, selection bias occurs when highly motivated patients are more likely to participate, participate at higher intensity, or more actively manage their disease. Second, regression to the mean occurs when program eligibility is determined by high use of health care services. That is, patient medical costs and health care use tend to decline in the period following program eligibility (even in the absence of a disease management program) when participants are identified on the basis of their high health care use. Third, the opt-out design does not allow for a concurrent natural comparison group to quantify program effect.We identified a historical control group (HCG) and used this group's information to develop equations predicting outcomes for patients in the absence of a diabetes management program. To estimate program effect, we calculated the mean difference between patients' observed and predicted outcomes.To create the analytical database, we used a unique patient identifier that linked medical and pharmacy claims from the Defense Health Information Management System Clinical Data Repository, patient characteristics from the Defense Enrollment Eligibility Reporting System, and disease management services received as indicated in the patient tracking information systems of the 3 disease management service providers. An institutional review board  approved the study protocols.On the basis of a literature review and data availability, we chose indicators considered best practices for evaluating program performance -9. IndicFrom the 37,370 patients who were eligible for the program, we excluded 1) 3,021 patients with fewer than 6 months’ program enrollment (for insufficient time to complete the program), 2) 449 patients not continuously eligible for TRICARE during the evaluation period, 3) 218 patients who became eligible for Medicare , 4) 154 patients who died or had HIV/AIDS or end-stage renal disease (ESRD), and 5) 3,924 opt-out patients. The final sample contained 29,604 patients; the median program tenure was 15 months .After TRICARE Management Activity identified candidates for the program, the disease management provider for each region contacted patients by letter and by telephone. Patients could choose to receive personalized counseling by telephone and mailing, to receive only the newsletters and other mailings, or to have no further contact with the program . The disease management providers did not record patients' reasons for opting out. However, care managers said that opt-out patients' typical reasons for choosing not to participate is that they would be unable to complete the program because of impending military transfers and enlistment terminations, did not have diabetes, or previously participated in other diabetes management programs and did not believe they would benefit from participating in this program. Patients who opted out had similar demographic characteristics to those of participants but had slightly higher medical costs in the year preceding program eligibility.The patient-level analytic file linked medical claims to program participation records. For each patient, we summarized health care use during 2 periods. The identification period was 1 year preceding the eligibility date; the postidentification period varied from 7 months to 15 months after the eligibility date. The outcome variables for each patient, standardized to a 12-month period, take into account a patient's program tenure. Although medical claims for participants were available through March 2009, to control for the time lag in claims processing and adjudication and to ensure we had complete claims data for participants, we allowed a minimum of 6 months from date of service to the final record extraction date and ended the observation period at September 30, 2008.International Classification of Diseases, Ninth Revision, 250.02, 250.03) during the year preceding program eligibility. Although lack of a medical claim with a diagnosis of uncontrolled diabetes does not necessarily mean a patient's glucose level was controlled, for discussion purposes we refer to these patients as having "controlled" diabetes.We categorized patients as having uncontrolled diabetes if they had at least 1 episode of care with the  diagnosis code for uncontrolled diabetes  and sex; TRICARE region; military service branch; number of ED visits, inpatient days, ambulatory visits, and 30-day prescriptions; indication of uncontrolled diabetes; Charlson comorbidity index score ,13; and Regression results, available from the authors on request, are consistent with expectations. For example, sicker patients  in the November 2003 through October 2004 period had higher average health care use and costs in the November 2004 through October 2005 period. The goodness-of-fit measures for the regressions — based on root mean square error for continuous outcomes and receiver operating curve for dichotomous outcomes — suggest that the regressions are robust. We used the regression coefficients based on these HCG analyses to predict program participants' annual health care use and costs.Of the 29,604 participants in the analytic sample, 12,776 (43%) had indications of uncontrolled diabetes in the year preceding program start . The ratThe HCG was similar to the program participant group in demographic characteristics, medical costs, and health care use. However, patients in the HCG had lower rates of receiving appropriate tests, particularly HbA1c and microalbumin urine tests.Because high health care use determined program eligibility, patient health care use and cost outcomes were higher in the year preceding program eligibility than in the year following eligibility (as extreme scores moved toward being less extreme). For the HCG, diabetes-related costs dropped by 28% and total costs dropped by 17% from the preidentification to postidentification period . HoweverProgram participants with prior indication of uncontrolled diabetes had higher observed diabetes-related costs per year  and highThe difference in observed and predicted outcomes (which controls for differences in case mix between subsets of program participants) suggests an average annual reduction in diabetes-related costs of $249 per person overall . The redThe average per-person reduction in total costs was $783 per year . The redThis study suggests that TRICARE's diabetes management program is associated with modest annual reductions in medical costs and improved receipt of recommended screening. Improvements were largest for active participants with prior indication of uncontrolled diabetes and smallest for patients with no prior indication of uncontrolled diabetes (whether active or passive participants). Active participants had greater improvements than passive participants in the proportion receiving appropriate screening. Increased costs for ambulatory care offset a portion of medical savings from reduced inpatient days and ED visits.Our estimates of average annual medical savings among all program participants  are within the range of estimates from other diabetes management programs. Published estimates for other programs, which may differ from this program in terms of population served and intensity of services, suggest an average annual per-patient savings of $626 in diabetes-related costs  -16. ThisA major contribution of our study is that patients with prior indications of uncontrolled diabetes appear to experience greater program benefits than do patients with no indication of uncontrolled diabetes in the 12 months preceding program eligibility. Patients with uncontrolled diabetes who want to improve their self-management skills (as indicated by active program participation) likely have the most to gain from an education-based diabetes management program.Compared with passive program participation, active participation is associated with larger reduction in inpatient days and ED visits and higher rates of recommended screening. Active participants also experienced larger increases in ambulatory visits and smaller decreases in use of medications. These differences in outcomes by participation intensity were not as pronounced as expected. The voluntary nature of this program, in which patients could choose their participation intensity, warrants caution when making comparisons between active and passive participants. We controlled for differences between active and passive participants, such as active participants' slightly higher preprogram expenditures for diabetes-related health care services, by using prediction equations. In addition, we controlled for differences that likely correlated with patients' motivation to improve their health: active participants had higher rates of receiving at least 1 HbA1c test, retinal examination, and microalbumin urine test annually.This study had several limitations. Patients could opt out of the disease management program, whereas the HCG had no opt-out component. Anecdotal evidence suggests that many who opted out would have been excluded from the HCG, for example, patients who would soon be leaving the Military Health System. Observed characteristics for the opt-out group were similar to those of program participants. The opt-out nature of this program also meant that there was no similar concurrent control group.The HCG was part of our study design because comparing program outcomes for TRICARE's disease management program with outcomes from published literature would have posed multiple problems. These include the datedness of published findings and the differences in populations, diseases, program designs, and insurance benefits. Identifying an HCG that met the eligibility criteria for program participation within the TRICARE health plan limited these issues. By using prediction equations, we could control for differences between the HCG and program participants . A limitUnobservable differences between active and passive participants may explain the smaller-than-expected differences in outcomes. Our study, for example, does not control for the possibility that patients received adequate diabetes counseling from other sources . Such information is unavailable for both the HCG and the program participants. If patients who already receive good diabetes counseling from other sources are more likely to be passive participants then our prediction equations could overestimate the program's effect on passive participants and underestimate the effect on active participants when comparing observed with predicted outcomes.Another limitation is the inability to precisely identify patients whose diabetes is controlled. The unavailability of laboratory results  prohibited us from testing whether patients with extremely high glucose levels benefited from the program more than patients with moderately high glucose levels. Some patients with no diagnosis code for uncontrolled diabetes undoubtedly had uncontrolled diabetes, and some patients with a prior diagnosis of uncontrolled diabetes likely had their diabetes under control at the start of disease management. This inexactness in identifying patients with uncontrolled diabetes may reduce the estimates of program differences by uncontrolled status.TRICARE's education-based disease management program was associated with modest reductions in annual medical costs and more appropriate use of health care services. Patients with prior indications of uncontrolled diabetes actively participated in the program at the same rate as patients with no indication of uncontrolled diabetes, and they appeared to benefit more from the program, leading to higher cost savings. This finding suggests that patients with indications of uncontrolled diabetes are strong candidates for participation in diabetes management programs.