Presentations to hospital of older people receiving family care at home incur substantial costs for patients, families, and the health care system, yet there can be positive carer outcomes when systematically assessing/addressing their support needs, and reductions in older people’s returns to hospital attributed to appropriate discharge planning. This study will trial the Further Enabling Care at Home program, a 2-week telephone outreach initiative for family carers of older people returning home from hospital. Hypotheses are that the program will (a) better prepare families to sustain their caregiving role and (b) reduce patients' re-presentations/readmissions to hospital, and/or their length of stay; also that reduced health system costs attributable to the program will outweigh costs of its implementation.N = 180 dyads). Carers will be randomly assigned  to receive usual care (control) or the new program (intervention). The primary outcome is the carer’s self-reported preparedness for caregiving . To detect a clinically meaningful change of two points with 80 % power, 126 carers need to complete the study. Patients’ returns to hospital and subsequent length of stay will be ascertained for a minimum of 3 months after the index admission. Regression analyses will be used to determine differences in carer and patient outcomes over time associated with the group (intervention or control). Data will be analysed using an Intention to Treat approach. A qualitative exploration will examine patients’ and their family carers’ experiences of the new program (interviews) and explore the hospital staff’s perceptions (focus groups). Process evaluation will identify barriers to, and facilitators of, program implementation. A comprehensive economic evaluation will determine cost consequences.In this randomised controlled trial, family carers of older patients aged 70+ discharged from a Medical Assessment Unit in a Western Australian tertiary hospital, plus the patients themselves, will be recruited at discharge (This study investigates a novel approach to identifying and addressing family carers’ needs following discharge from hospital of the older person receiving care. If successful, the program has potential to be incorporated into routine post-discharge support.ACTRN12614001174673.Australian and New Zealand Clinical Trial Registry:  This study is being conducted in metropolitan Western Australia (WA), where increasing numbers of older people are experiencing multiple chronic health conditions, disability, and high level health care utilization . This siFor older people receiving care and in poor health, readmissions to hospital are potentially distressing and costly, yet sometimes avoidable with high quality discharge planning . A key cIn parallel work in community palliative care in the United Kingdom, a need for a systematic and effective carer needs assessment process was identified. The Carer Support Needs Assessment Tool (CSNAT) was developed following extensive reviews of the literature –12, and H1: That the enhanced support of family carers facilitated by the FECH program will prepare families to sustain their caregiving role better than usual care.H2: That, because family carer roles are better supported, implementation of this program will reduce (a) patients’ re-presentations and readmissions to hospital within 3 months of discharge, and (b) length of hospital stay when readmissions do occur.H3: That reduced costs to WA Health will outweigh costs of implementing the program.The aim of this study is to determine how implementing an evidence-based, systematic, and targeted support program for family carers of older patients - immediately after the patient’s discharge from a metropolitan Western Australian hospital’s MAU - impacts upon these carers; the patients for whom they provide care; and costs to WA Health, the local health care system. The program being evaluated is termed the Further Enabling Care at Home (FECH) program, and it uses the CSNAT to identify and prioritise family carers’ support needs that are subsequently addressed. The study has three hypotheses:Compare family carer preparedness to care between those included in the FECH program and those receiving usual care.Compare patient outcomes from the FECH program versus those from usual care in terms of re-presentations to Emergency Departments (EDs), readmissions to hospital within the months (at least 3) following the index separation date – also Length of Stay (LoS) if readmission does eventuate.Document costs of a suitably qualified nurse (FECH nurse) implementing the program to inform the economic evaluation and determine a sustainable full time FECH nurse ‘caseload’.Compare costs of re-presentations to EDs, hospital readmissions, and LoS between the intervention group (FECH program) and the control group .Estimate overall cost effectiveness for the local health system from FECH program implementation during the study period.Explore and describe family carers’ perceptions of how the FECH program impacts upon caregiving sustainability plus any other outcomes for them; also how it might be refined to (a) minimise any negative outcomes, (b) enhance those that are positive, and (c) (further) enhance caregiving sustainability.Explore and describe patients’ perceptions of how the FECH program impacts upon them and how it might be refined to ensure the best possible outcomes (for them).Use process evaluation and obtain perspectives of MAU health care professionals to determine how the FECH program’s implementation might be improved.Refine the program from study recommendations and develop a plan to embed it into practice in the study setting and other similar health services.Develop a plan for testing the FECH program in other health settings – should it be shown to have cost benefits and no negative patient/carer outcomes when implemented in the MAU.Study objectives are to:Randomised Controlled Trial (RCT) , adhering to CONSORT guidelines for transparent reporting [Qualitative Evaluation and FECH program Process Evaluation will also be undertaken. The study will also be supported by an expert reference group. The RCT will compare outcomes between the control condition  and the experimental condition . Approval has been received from the Sir Charles Gairdner Group Human Research Ethics Committee (HREC) (2014–133), the Department of Health WA HREC (2014/78), and from the Curtin University HREC (HR14/2015).This is a mixed methods study addressing objectives and testing hypotheses in a single blind eporting , during The MAU is a 36-bed unit providing intensive assessment and treatment for patients with acute medical conditions, most of whom are over 70 years of age. MAUs are widely implemented in the UK, Australia and New Zealand in response to the need to increase patient through-put  and sustIncluded participants will comprise dyads of older people (aged 70+) discharged home from the MAU during the recruitment period and their adult aged 18+), English speaking, family carers (one per patient). The definition of a family carer is that used in a recent Australian study investigating the care of frail older people: “a family member or friend who provides unpaid personal care, support and assistance” [+, EnglisCarer participants in the intervention group will receive standard care plus the FECH program implemented by the FECH nurse who will be appropriately skilled and trained. Currently there is no nurse involved in providing the FECH or any similar program to patients or carers.Contacts will be made by telephone, after discharge Fig. . The FECStandard discharge ‘care’ includes the provision of a letter from the MAU’s physician to the patient’s general practitioner, with a copy provided to the patient. Medications are provided/organised by the MAU pharmacist. The MAU information booklet provides information about post-discharge support options and is intended to be taken home. Carers regarded as ‘at particular risk’ by the social work team receive social work assessment and links to services. Services put in place for patients may include a variety of care packages or programs. Information packs from Carers Australia are made available in the hospital rooms. Any one or more of these options considered by treating ward staff to be relevant to the patient and their carer will be provided as usual care.The primary outcome is preparedness for caregiving, to be measured with the Preparedness for Caregiving Scale (PCS) from the Family Care Inventory  (T1- T3)Data on potentially confounding variables will be collected to help inform interpretation of results. Carer rated patient Symptom Assessment Scale scores  and careBased upon recent findings using the CSNAT tool , caregivA Research Officer RO1) will develop a schedule for collecting data from all participating family carers (both groups) by telephone, at the time of recruitment to the study. At baseline assessment (T1), RO1 will also collect demographic details of the patient and the carer from the carer, including the carer’s familial relationship with the patient, age and gender (carer and patient), highest education level, occupation, usual place of residence, country of birth, years in Australia, support provided for the patient, contact with the patient, length of time caring for the patient, education received to help in the caring role, location of care, whether currently living with patient , any care provided by others, and known current medical conditions (patient and carer). Brief, robust measures to minimise questionnaire burden will then be administered (each contact is estimated to last approximately 30 min). Questionnaire administration across the three assessments  is summarised in Table  will devQuantitative patient outcome data will address Western Australian health care system utilisation and will be obtained through linked administrative health data provided via the WA Data Linkage System (WADLS) . These DThe data retrieved from data linkage will cover the time period from the date of the index separation of the patient whose carer is the first to be recruited to the study until 3 months after the index separation of the patient whose carer is the last to be recruited. Since recruitment is planned to last approximately 6 months, this time period will cover approximately 9 months.The primary outcome is the total score on the Preparedness for Caregiving Scale . An imprFigure Although the primary study outcome relates to carers of patients discharged from the MAU, other outcomes relate to the former patients themselves so carer/patient dyads will be recruited. Whenever a patient aged 70 years or older is admitted to the MAU during the recruitment period, family carers - and, when appropriate, patients - will be provided with information about the project and asked to provide written consent to participate in the study by RO1. However, many patients are likely to be too unwell to be approached with information about the study during their hospitalisation and are likely to experience ongoing poor health that may also fluctuate . Others To facilitate the assignment to group (control or intervention) of participants, a list of treatment allocations will be prepared before the study commences; it will contain a study number , and a code to indicate the group (intervention or control). The list of codes will be obtained using a sequence of computer-generated random numbers, and organised so that recruitment to the two study arms occurs at an approximately equal rate (using a permuted random block strategy). Allocation of participants to their treatment group will occur as follows: as each new dyad is recruited to the study, the next study number will be allocated to them (next in sequence on the list), and the treatment allocation for that study number will be read from the list.An ‘exit’ telephone interview will be conducted with an estimated 30 carers in the intervention group and, when possible, the older people receiving care from them (estimated 20). These participants will be purposively sampled on the basis of questionnaire data to cover a wide variety of carer profiles . The sample will be extended if issues need further exploration and until data saturation is reached.Interviews will occur within two weeks following administration of the final measures, to: investigate how the FECH model affected the participants, assess the support provided, identify factors influencing feasibility/usefulness, and assess how the FECH model could be improved. Written informed consent for participation will be obtained separately for this step and will involve mailing the information sheet and consent forms (for the carer and for the patient); then following up with a phone call during which questions can be answered, before requesting the return of the completed consent form in a prepaid study envelope. It is anticipated that the interviews will take approximately 30 min. A second telephone call will be offered if the interview takes longer than 30 min and the carer wishes to provide further relevant information.A focus group interview will be convened with the MAU staff as soon as carer recruitment for the trial has been completed. The staff working on the unit during the trial will be invited to take part and will be asked to comment on any impact from the FECH program on the Unit and to suggest: program refinements that would minimise negative outcomes and maximise those that are positive, how the program could be integrated into practice, and how its sustainability could be addressed. The staff members will be invited to take part by mail, and will also be sent an information sheet and consent form.Evaluation of FECH program processes will involve the FECH nurse documenting, during the trial: (a) adherence to, or deviation from, planned FECH processes; (b) information provided to carers and the resources to which they were referred; (c) the extent to which carers engaged with resources; (d) the contextual factors that were barriers to, or facilitators of, resource and service access and engagement; and (e) costs issues – primarily time taken to implement processes. This documentation will be achieved using an electronic database developed at the same time as the process manual and completed by the FECH nurse as the process is implemented.Group assignment will be concealed from RO1. When RO1 conducts the T1-T3 data collection telephone questionnaire administration, he or she will commence the conversation with a request to the participant (the carer) not to mention any phone calls from other study personnel. This reminder will not always be sufficient to prevent disclosure, and instances when it occurs will be documented to inform study reports. In a previous study, quantification of any ‘unblinding’ involved asking the hospital staff to identify to which group they thought patient participants had been assigned . In thisData analyses will be performed using the IBM SPSS statistical software package . A p-valStandard descriptive statistics  will be used to summarise the characteristics of participants in the study . Chi-square tests and t-tests will be used to compare the treatment groups (intervention versus control) on the basis of these variables. It is anticipated that there will be no significant differences between groups in terms of demographic characteristic or potentially confounding variables, which will confirm that the randomisation process has allocated participants evenly to each arm of the study.t-test will compare changes between treatment groups. If changes in scores are not normally distributed, a non-parametric method will be used instead (Wilcoxon 2-sample test). In the (unlikely) event that groups differ on the basis of baseline variables, a regression model will be used instead of the t-test, so that these potentially confounding variables can be taken into account. A random effects regression model will be used to examine changes in the Preparedness for Caregiving Scale score over all three data collection periods (instead of just baseline/end of study). This model will be used so that correlations between measurements made on the same participants can be taken into account. Results of the model will help show whether changes in scores happen soon after recruitment, or later. The model can be extended to adjust for other potentially confounding variables.Outcome analysis will be conducted using an Intention to Treat approach. The change in the total Preparedness for Caregiving Scale  score bet-test (after log-transformation of the data if indicated). Number of re-admissions to hospital or presentations to ED will be compared using the same method. A regression model will be used to take into account potentially confounding variables (if relevant). The association between change in preparedness and change in health care utilisation will be evaluated using carer outcomes linked to the administrative data.Patient outcomes will be compared between groups using t-tests or regression models. For example, the total length of hospital stay will be calculated and compared between groups using a Since a randomised controlled trial is being undertaken to determine the efficacy of the new support program for older patients’ carers, the economic evaluation reflects a service substitution model without cost sharing or transfer. Costs of the program will be evaluated using prospective data collection for each patient/carer dyad (cases and controls) and will include the costs associated with the intervention and outcomes using a Western Australian health system perspective.Program costs in addition to those for usual care will include those documented during the process evaluation, in particular: (1) training of the FECH nurse to implement the program; (2) the FECH nurse salary; (3) costs associated with providing discharge information to carers (costed on a case by case basis) – FECH nurse time and web access (to identify service providers), any costs for communication that is part of the intervention, and stationery used. Costs associated with research components/activities will be excluded since they would not be incurred if the program was taken up. Outcome costs associated with utilisation of health services during follow up for patients (cases and controls) will include: (1) cost of ED visits, (2) cost of additional in-patient hospitalisation, and (3) cost of ambulance use.In-patient costs will be calculated using Diagnostic Related Group (DRG) based costings from the appropriate cost report available from the Australian Government Department of Health. Since Urgency Related Group (URG) is not available directly from the ED data, cost of ED attendances will be based on derivation of the closest urgency related/disposition group using data obtained from the Standard Emergency Record Information. The derivation algorithm follows as closely as possible the URG Grouper application developed by the Independent Hospital Pricing Authority (IHPA) which uses Episode End Status, Type of Visit, Triage, Sex, and Diagnosis Code. Costing will then be undertaken using the price weight of the URG and National Efficient Price provided in the closest IHPA National Efficient Price Determination report to the date of the episode .Patient ambulance utilisation will be costed at $AUD898 per service. The use of ambulance services will be obtained via the hospital mortality data system data  and ED  data sets.Costs and outcomes associated with delivering the intervention will be compared using cost-consequence analysis, a variant of cost-effectiveness analysis in which the components of incremental costs and outcomes are computed and listed without aggregating these results into an overall ratio. Cost-consequence analysis provides a more comprehensive presentation of information than other types of economic evaluation and is appropriate for complex interventions that generate outcomes that cannot meaningfully be expressed using a single metric such as those in this study. Consequences (outcome measures as described above under patient and carer data) and net costs (cost of intervention minus cost savings produced by the intervention) will be tabulated to allow analysis of incremental cost per net change for each outcome.A decision tree analysis using TreeAge Pro 2015  will evaAs with all research, this study will incorporate assumptions, uncertainties, and variability in the data. To evaluate the importance of the assumptions and uncertainties, comprehensive sensitivity analyses (deterministic and probabilistic) will be performed. Sensitivity analyses strengthen economic evaluations by indicating the stability of the reported outcome and identifying which variables have the most influence on it. This step will provide an estimation of likely generalisability of the cost-consequence estimate outside the trial. Examples of uncertainties and variables are in Table All interviews will be audio-recorded and transcribed verbatim. Analysis will be aided by the use of the NVivo software program . ResponsFindings from the process evaluation will be summarised to support recommendations. In addition, a feasible ‘caseload’ for a full-time FECH nurse will be determined.Increasing numbers of older people are experiencing multiple chronic health conditions, disability, and high level health care utilization . StrategThis study investigates a novel approach to identifying prioritised carers’ needs in the immediate weeks post- discharge from hospital of the older person for whom they are providing informal care - evaluating a program aimed to support carers in this challenging time of re-acclimatisation to the home environment that has been shown to be associated with high risk of hospital re-admission . ImportaThe study also includes a comprehensive economic evaluation of the intervention, with robust service use data obtained via the comprehensive Western Australian Data Linkage System such as hospitalisation, ED use, and death and morbidity data. Results of this analysis will inform health services of the cost effectiveness associated with implementing the FECH program more widely across the health system.In summary, this randomised controlled trial with embedded economic evaluation will determine carer, patient, and health service outcomes associated with introduction of a carer support program for carers of older patients being discharged from an acute medical unit in a tertiary hospital. The program may be appropriate for incorporation into routine post-discharge support if shown to be effective and if costs of implementation are offset by resultant cost savings.


This rare surgical procedure was successfully employed in a patient with cutaneous malignant melanoma and nodal metastases at the popliteal fossa. The technique described by Karakousis was reproduced in a step-by-step fashion to allow anatomical identification of the neurovascular structures and radical resection with no post-operative morbidity and prompt recovery. Popliteal lymph node dissection is a rarely performed operative procedure. Following a lymphoscintigraphic examination of the popliteal nodal station, surgeons can be asked to explore the popliteal fossa. Detailed familiarity of the operative procedure is necessary, however, to avoid complications.Popliteal lymph node dissection is performed when grossly metastatic nodal disease is encountered in the popliteal fossa or after microscopic metastasis is found in interval sentinel nodes during clinical staging of cutaneous malignant melanoma. Initially, an S-shaped incision is made to gain access to the popliteal fossa. A careful  Metastasis to the lymph nodes represents the most important predictor of disease outcome among patients with malignant melanoma (MM) of the skin. UsuallyWhen metastatic disease is identified in the popliteal fossa, surgeons are called on to explore the popliteal nodal station and perform radical lymphadenectomy. This necessitates a profound familiarity of the surgical anatomy and the technique of this uncommon operative procedure.In our clinic, this procedure was recently performed in a patient with MM of the heel, presented with concomitant popliteal and inguinal lymph node metastases. In this communication, a detailed description of the surgical anatomy is provided and the technique of the popliteal lymph node dissection is described.The patient (JRS), a 58-year-old man was subjected to an excisional biopsy of a dark skin lesion in the left foot. On light microscopy, an acral melanoma was diagnosed, with a Breslow thickness of 1.5 mm. Clinical staging was T2 N0 M0, with a normal LDH (355 mg/dL) and normal chest and abdomen CT findings.Based on the clinical stage and Breslow thickness, a sentinel node biopsy and a wide-margin excision were carried out. On lymphoscintigraphic examination, a major uptake of radionuclide was localized in the popliteal and groin lymph nodes, which were excised and submitted to histopathological examination. These lymph nodes were deemed positive for metastatic melanoma and, consequently, a lymphadenectomy of the deep and superficial groin as well as popliteal regions was indicated. After this procedure, histopathological examination disclosed seven popliteal lymph nodes, all being disease-free.en bloc removal of all fibrous, fatty, and lymphatic tissue in the popliteal fossa, with careful preservation of the nerves and vessels.Normally, there are 2 to 9 lymph nodes localized within the fat tissue surrounding the nerves and major vessels of the popliteal fossa. Popliteal lymph nodes are deep structures encountered under the investing fascia of the leg, and they receive the lymphatic drainage of the deep structures of the distal leg and foot. Although infrequent, the lymphatic drainage from the skin is direct to these lymph nodes in some individuals. The surgical procedure of popliteal lymph node dissection involves The patient is placed in the prone position with the knee slightly flexed. To gain access to the popliteal fossa, an S-shaped incision is performed Figure . The latThe upper angle of the popliteal fossa is formed by the biceps and semimembranosus muscle. Medially to the edge of the biceps femoris muscle, the common peroneal nerve is identified through a layer of fat tissue. An ascending sharp dissection is made superficially to the nerve until the level of its origin from the sciatic nerve. This careful dissection continues distally until the surface of the peroneus longus muscle. At this point, the tibial nerve is also dissected in the popliteal space superficially to the popliteal vessels and both nerves are hooked with vessel loops to allow gentile lateral traction Figure .Emerging from the lateral surface of the peroneal nerve, we can identify the lateral sural cutaneous nerve Figure . This neThe deep fascia is stripped off the surface of the gastrocnemius muscle, and the medial cutaneous sural nerve is hooked with vessel loops, like the lateral sural cutaneous nerve, both being held laterally. The popliteal vessels are now approached. The popliteal artery is medial to the popliteal vein and lies deeper. Both are located between the heads of the gastrocnemius muscle Figure .The descendent dissection continues and the small saphenous vein is ligated close to its insertion in the popliteal vein Figure . All fibThe superficial lymphatics localized on the calf may accompany the short saphenous vein towards the popliteal fossa draining to popliteal lymph nodes. In a series from the Sidney Cancer Database, there wThere are two basic indications to perform popliteal lymph node dissection: i) grossly metastatic disease detected on clinical examination or ii) microscopic disease identified in sentinel node lymphadenectomy specimens. PopliteIn 1980, Karakousis published an elegant description of this infrequent operative procedure with detailed information about the surgical anatomy and the technique. Since tTo guarantee sufficient exposure, a progressive dissection, initiated by the confection of the lateral flap, was continued throughout removal of all soft tissue. The subsequent surgical steps are followed according to the same principle of removing all fibrous and fatty tissue around, beneath, and alongside the popliteal vessels and nerves. After retraction of the flaps, an easy identification of the peroneal nerve and its ascending dissection until its origin in the sciatic nerve offers prompt identification of the tibial nerve. Subsequent recognition of the sural cutaneous nerves and their branches makes the dissection secure. The next crucial step involves the resection of all fat pad tissue close to the popliteal vessels. Meticulous inspection and palpation of the popliteal fossa must be performed not to leave any lymph node undetected.When a surgeon faces a rare surgical problem of regional nodal disease outside the common nodal stations, such as popliteal or epitrochlear chains, the knowledge of anatomy and surgical technique is crucial to guarantee preservation of the key functional structures to avoid permanent disability. Inappropriate dissection can also result in a suboptimal radical lymphadenectomy. The technique of popliteal lymph node dissection described here was successfully performed in a patient with metastatic acral MM, without any post-operative complications or morbidity.Written informed consent was obtained from the patient for publication of this case report and any accompanying images. A copy of the written consent is available for review by the Editor-in-Chief of this journal.The authors declare that they have no competing interests.FT and EA designed and operated on the case reported. VM and SC made substantial contributions to conception, design, and acquisition of data. ML, TL, GM, and AP wrote the manuscript and edited photographs. SR and EU finally reviewed and actively edited the manuscript. All authors read and approved the final manuscript.


The interactions between the anti-TMV compounds and the TMV CP disk were analyzed by size exclusion chromatography, isothermal titration calorimetry and native-polyacrylamide gel electrophoresis methods. The results revealed that assembly of the four-layer aggregate disk was inhibited by NNM; it changed the four-layer aggregate disk into trimers, and affected the regular assembly of TMV CP and TMV RNA. The four-layer aggregate disk of TMV CP was little inhibited by ATF, DFL and BQX. Our results provide original data, as well as new strategies and methods, for research on the mechanism of action of anti-viral drugs.Studies of the targets of anti-viral compounds are hot topics in the field of pesticide research. Various efficient anti-TMV (Tobacco Mosaic Virus) compounds, such as Ningnanmycin (NNM), Antofine (ATF), Dufulin (DFL) and Bingqingxiao (BQX) are available. However, the mechanisms of the action of these compounds on targets remain unclear. To further study the mechanism of the action of the anti-TMV inhibitors, the TMV coat protein (TMV CP) was expressed and self-assembled into four-layer aggregate disks  Streptomyces nourseivar. xichangensis. Some reports have indicated that NNM is a good anti-viral drug .,33.Kd erN. glutinosa by mechanical inoculation. The leaves on N. glutinosa of the same ages were selected. The reconstituted TMV with 58.8 μg/mL concentration was dipped and inoculated on the whole leaves. Then the leaves were washed with water and dried. The compound solution (100 and 500 μg/mL) was smeared on one side and the buffer was smeared on the other side for control. The local lesion numbers were then recorded 3–4 days after inoculation. For each compound, three repetitions were conducted to ensure the reliability of the results. The in vivo assays were showed in (We performed the efficacy of BQX, DFL, ATF and NNM on reconstituted TMV virus infection by howed in  as folloTMV CP disk were used as targets of anti-viral compounds. In our study, TMV CP disk were disassembled into trimers when the NNM solution concentrations increased; and TMV CP disk were partly disassembled into trimers or dimers when ATF was added. By contrast, the disk showed little disassembly into trimers or dimers with the addition of DFL and BQX. The results demonstrated that there were interactions between NNM and TMV CP disk, and that interactions between the inter-subunits and layers of the TMV CP disk were disrupted by NNM. We speculate NNM replaced the binding sites in the disk and disrupted the interactions between the inter-subunits and layers of the TMV CP disk.To the best of our knowledge, this study is the first to clearly show the inhibition of the TMV assembly through a small-molecule-protein interaction. This approach provides original data, as well as alternative strategies and methods, which can be used in anti-viral drug mechanism research.


The aim of the present study was to investigate the impact of the Great East Japan Earthquake on laboratory findings in chronic hemodialysis (HD) patients in Fukushima.Changes in laboratory findings and cardiothoracic ratio (CTR) between before and after the earthquake were retrospectively analyzed in 90 adult HD patients with end-stage renal disease (ESRD). Two hospitals located within 80 km from the Fukushima Daiichi Nuclear Power Plant, where American government recommended to evacuate from the area, participated in the study. HD duration was shortened by 0.5-1 hour for 1 month after the earthquake. Multivariate analyses were performed to identify the factors contributing to change of measurement values.P=0.002). In multivariate analysis, age showed a tendency to be related to the decrease of BUN level (P=0.05). Hematocrit value was significantly elevated after two months compared with that at baseline (P=0.02), although the elevation was small. The other measured values and CTR were not significantly changed compared with those before the earthquake.Blood urea nitrogen (BUN) value was significantly transiently decreased for 1-2 weeks after the earthquake (Laboratory findings and CTR did not worsen despite the shortening of HD duration. Hence, in this disaster, as far as chronic HD patients with ESRD were concerned, it was possible for the duration of HD treatment to be safely decreased. The Great East Japan Earthquake, measuring 9.0 on the Richter scale, struck Fukushima prefecture on March 11, 2011. About 20,000 people died or disappeared due to the direct effects of trauma by the earthquake as well as a huge tsunami that subsequently occurred. In Fukushima prefecture, secondary damage associated with this disaster occurred due to an accident at Fukushima Daiichi Nuclear Power Plant, which was a Level-7 nuclear event, defined as the most serious on the International Nuclear and Radiological Event Scale (INES). Several explosions and other events led to the scattering of a large amount of radioactive substances into the air, water, and soil[After the disaster, infrastructure, such as roads, bridges, rail, water pipes, and telecommunication systems, was severely damaged. In addition, the flow of various supplies, such as food, water, medicine, and gasoline, was interrupted. The main causes of this interruption were that the infrastructure was severely damaged and that individuals tasked with transporting such supplies were not willing to enter Fukushima prefecture because of fears about the possibility of radiation exposure associated with the nuclear accident. Moreover, supplies could not be gathered directly from other prefectures owing to a shortage of gasoline. As such, there was the potential for an increase in physically or psychologically adverse effects for not only healthy people but also patients with chronic conditions like end-stage renal disease (ESRD) requiring hemodialysis (HD) in the affected area. Residents in the area were compelled to consume relief food for days or weeks as a result of this situation. Relief food contains high potassium levels or high salt levels to preserve it against decay,3. WhileAlthough the impact of a major disaster on HD patients with ESRD has been investigated in several studies-8, an anThis study included 90 adult HD patients with ESRD who had been on maintenance HD three times weekly (4 hours per session) for at least 3 months before the earthquake in Fukushima prefecture. Changes in laboratory data, cardiothoracic ratio (CTR) on chest radiographs and interdialitic weight gain before and after the earthquake were retrospectively analyzed. Two hospitals participated in this study. One is Soma Central Hospital, located 2 km away from the coast, which suffered from serious damage from the huge tsunami that resulted from the earthquake, which took the lives of 475 people living in Soma city. In addition, Soma city is located 40 km away from Fukushima Daiichi Nuclear Power Plant. The other hospital is Hanawa Welfare Hospital, which was not damaged by the tsunami and is located 70 km away from Fukushima Daiichi Nuclear Power Plant. However, both hospitals were located within 80 km from the Fukushima Daiichi Nuclear Power Plant, where American government recommended to evacuate from the area Figure . Then, tThis study complied with the Declaration of Helsinki and was approved by the ethics committee of Hanawa Welfare Hospital and the ethics committee of Soma Central Hospital. All participants read and signed an informed consent form prior to this investigation.2 surface area dialyzers with bicarbonate-based dialysates ; bicarbonate, 30 mEq/L (mmol/L); potassium, 2.0 mEq/L (mmol/L); calcium, 3.0 mEq/L; and magnesium, 1.0 mEq/L). The blood flow rate was 150-200 ml/min. The dialysate flow rate was 500 ml/min. The dialysate temperature was 36.5°C. The mean value of Kt/V before the earthquake was 1.01±0.16. However, soon after the earthquake, our department, which was composed of some board-certified specialists for dialysis, rapidly decided to reduce the HD duration at both our affiliated hospitals. Because we anticipated the difficulties in saving the dialysate and tap water, moreover, both hospitals received the hemodialysis patients from other hospitals and performed hemodialysis for them, we decided to shorten dialysis duration.The overall number of dialysis machines is 44 . All patients underwent HD three times weekly (4 hours per session), using 1.2-2.1 mHD duration was shortened by 1 hour for about 2 weeks, and was then shortened by 0.5 hours for the next 2 weeks because of incomplete recovery from damage to the infrastructure, and thus both hospitals had low reserves of water, dialysates, medicines, and so on.1c (HbA1c) concentration were analyzed. FBS and HbA1c were tested only for the patients diagnosed with diabetes mellitus.Blood samples were drawn before and after HD. Blood urea nitrogen (BUN), creatinine, sodium, potassium, chloride, hemoglobin, hematocrit (Hct), fasting blood glucose (FBS), and hemoglobinACTR was measured on chest radiographs. Standard chest radiographs were taken in a standing position via the posterior-anterior view. CTR was determined by dividing the maximal horizontal width of the heart by the horizontal inner width of the rib cage.Blood examination results and CTR from just before the earthquake were picked up as baseline data. After the earthquake, measurement values in the first/second week (first examination), and those in the fourth week (second examination), and the eighth week (third examination) were picked up as post-earthquake data.U test was used to determine significant differences of values in binary variables. The correlations between measurement values and continuous variables were investigated by simple regression analysis using the Spearman rank correlation coefficient. Multivariate analyses were performed using multiple linear regression to identify the factors contributing to change of measurement values. P-values < 0.05 were considered significant. Analyses were performed with StatView version 5.0 software .All values are presented as mean ± standard deviation or median. Time-dependent change of values was statistically analyzed using one-way analysis of variance with the Bonferroni post hoc test. Two-sided Mann-Whitney P=0.002) (Table P=0.04) and increasing age (P=0.008) were significantly associated with the decrease of BUN level (Table P=0.05) (Table P=0.02), although the elevation was small (Table P=0.05) . Additionally, although we selected two hospitals with different levels of damage due to the tsunami and nuclear power accident, we did not show that the resultant differences in psychological stress might have led to differences in the BUN level in HD patients.The present study demonstrated that BUN level was significantly decreased during the first to second week (the first examination) after the earthquake. This finding suggests that transient anorexia or food restriction in chronic HD patients might have occurred, although Inui decrease. Then, wHct level was significantly elevated two months after the earthquake (the third examination) in the current study. The difference of hospital tended to be related to the increase of Hct level. However, as the elevation was small, it might not constitute clinically meaningful data.1c concentration was increased after the earthquake compared with that before it owing to chronic psychological stress[1c concentration changed after the earthquake. The reason for this discrepancy might be that, in the present study, we investigated ESRD patients with diabetes mellitus and the observation period was shorter in the present study than in the above-mentioned study.In the patients with diabetes mellitus at the Great Hanshin-Awaji Earthquake in 1995 in Japan, HbAl stress. Howeveret al. reported that the frequency of HD treatment could be safely reduced, although the laboratory findings were not investigated[In the Great Hanshin-Awaji Earthquake, a significant increase of CTR was transiently observed in chronic HD patients who were in the seriously damaged area during and after the earthquake. In the stigated. Indeed,Several limitations of the present study must be considered. First, this study included a small sample size. This may have limited the power to find associations between patient characteristics and change of laboratory findings and CTR. Second, we did not investigate every laboratory finding because of the shortage of laboratory chemicals. Third, we did not investigate the laboratory findings and CTR within 1 week after the disaster because the necessary equipment was not fully prepared. However, in Fukushima prefecture, in particular at the “exposed” hospital, this period might have been the most critical because of the shortage of supplies and the physical and psychological stress associated with the fear of nuclear explosions and earthquake-related events, such as another huge tsunami being triggered by the frequent aftershocks, as well as death in the family and the loss of property induced by the earlier tsunami.In the present study, laboratory findings and CTR were not exacerbated despite a shortening of HD duration. Hence, in this disaster, as far as chronic HD patients were concerned, it is possible that the duration of HD treatment could be safely decreased.INES: International nuclear and radiological event scale; ESRD: End-stage renal disease; HD: Hemodialysis; CTR: Cardiothoracic ratio; BP: Blood pressure; BUN: Blood urea nitrogen; Hct: Hematocrit.We declare that we have no conflicts of interest.NH, MK and HA carried out the studies of clinical trials and drafted the manuscript. HJ and MH participated in collecting and organizing of data. KI and NT performed the statistical analysis. KU, SO and YK conceived of the study, and participated in its design and coordination and helped to draft the manuscript. All authors read and approved the final manuscript.The pre-publication history for this paper can be accessed here:http://www.biomedcentral.com/1471-2369/14/239/prepub


The efficacy of drug-based treatments and psychological interventions on the primary negative symptoms of schizophrenia remains limited. Recent literature has distinguished negative symptoms associated with a diminished capacity to experience, from those associated with a limited capacity for expression. The positive emotions program for schizophrenia (PEPS) is a new method that specifically aims to reduce the syndrome of a diminished capacity to experience.The intervention’s vital ingredients were identified through a literature review of emotion in schizophrenia and positive psychology. The program has been beta-tested on various groups of health-care professionals.A detailed description of the final version of PEPS is presented here. The French version of the program is freely downloadable.PEPS is a specific, short, easy to use, group-based intervention to improve pleasure, and motivation in schizophrenia. It was built considering a recovery-oriented approach to schizophrenia. Negative symptoms have long been recognized as a central feature of the phenomenology of schizophrenia, dating back to early descriptions by Kraepelin and Bleuler . They neThe efficacy of drug-based treatments and psychological interventions on primary negative symptoms remains limited, however –9. FusarRecent literature has distinguished the negative symptoms associated with a diminished capacity to experience  from those who were associated with a limited capacity for expression  –20. The A symptom-specific strategy has been used in the development of specific therapeutic techniques for positive symptoms , 23 and Anhedonia has been defined as a reduction in the ability to experience pleasure. Despite its clinical significance, research into anhedonia has produced a paradoxical set of findings, raising questions about its nature. On the one hand, using self-reported measures of trait social and physical anhedonia, individuals with schizophrenia typically report experiencing lower levels of pleasure in their daily lives than non-patients –35. On tFurther emotional deficits may be present in schizophrenia  and shouWith this as a background, Jérôme Favrod and Alexandra Nguyen conceived an intervention, which they named the “positive emotions program for schizophrenia,” to reduce anhedonia and apathy. The program teaches skills to help overcome defeatist thinking , 56 and During its development, PEPS, as well as the sensitivity of self-reporting instruments, was beta-tested on volunteer health-care professionals in order to improve its efficacy on anticipatory and consummatory pleasure, as well as savoring. Four 1-day training sessions of 7 h of PEPS were beta-tested on four different mixed groups of health-care professionals. At the end of each session, oral feedback and advice were collected, as were pre- and posttest assessments. Sessions 1–3 were conducted between February and March 2014 using version 1.0 of PEPS. Session 4 was conducted in March 2015 using the improved version 1.1 of PEPS, developed on the basis of the results of the previous sessions.Participants were health-care professionals, including psychiatrists, psychologists, nurses, occupational therapists, and social workers, interested in participating in the program’s development. No participant followed more than one session. Participation was anonymous, and the subjects gave only their sex and age. The clinical studies with PEPS have the agreement of the Vaud Cantonal Ethics Commission on Human Research (127/14 and 446/15).•The Savoring Belief Inventory (SBI) is a self-reported scale for measuring beliefs about one’s capacity for savoring things. The scale has 24 items, including a positive scale (12 items) and a negative scale (12 items). The inventory has good validity and a high test–re-test reliability  and consummatory pleasure (8 items) (8 items) . Items t8 items) . The tot•The Anticipatory and Consummatory Interpersonal Pleasure Scale (ACIPS) ( (ACIPS) , 60 is dThe following measurement instruments were used:t-tests of pre- and posttest results were calculated using IBM SPSS Statistics Version 22. Cohen’s d effect sizes were calculated for within-subjects in correcting for dependence among means. Formula 8 from Morris and DeShon (Two-tailed paired sample d DeShon  was alsoTable The pedagogical concept underpinning PEPS was designed according to Kolb and Kolb’s model  of experThe program uses a collaborative, egalitarian approach. Group facilitators participate in sessions just as the participants do, by doing the exercises, sharing their experiences, and carrying out the given tasks. Group facilitators receive a day’s training before leading a group themselves and are supervised during two 1-h periods during the program.Each session includes a number of the following steps. Part 1 begins with a welcome, followed by a 5-min relaxation–meditation exercise. In part 2, group leaders go over the homework task given during the previous session. Part 3 involves an exercise in challenging specific defeatist thoughts, which are presented using the program’s two fictitious heroes – Jill and Jack. Jill, for example, expresses such defeatist thinking as “I can’t relax; I’m useless.” The participant’s role is to challenge her belief, initially by assigning different reasons to why Jill has difficulty relaxing. They learn to find reasons that might be linked not only to the program’s heroine but also to other people or her environment. They subsequently try to develop an alternative, more positive way of thinking.The following slides show how the exercise appears to the participants. This first slide presents a defeatist belief.The next slide presents questions to find a more balanced set of reasons to explain Jill’s belief that she is unable to relax. Since defeatist beliefs are often linked to the internal attribution of failures, participants are asked to find a set of different reasons to explain why Jill was not able to relax. These questions are asked by the group leaders to the participants. Each of the eight sessions of PEPS will address a defeatist belief using the same methods in order to facilitate patients’ understanding of how the method works.The third slide only appears after the participants have given answers to slide 2. Other suggestions are also given to complement or confirm the work they did for the previous slide.The fourth slide asks the participants to give an alternative to Jill’s conclusion and defeatist belief that she is useless.The final slide in this sequence about changing defeatist beliefs gives suggestions to complement or confirm the work the participants did for the previous slide.Subsequently, and according to the session’s theme, participants learn and practice a new skill to improve their anticipation or maintenance of pleasure. The session ends with group leaders setting the homework task that the participants must accomplish for the next session.The skills taught include savoring a pleasant experience, expressing emotions by increasing behavioral expression, making the most of or capitalizing on positive moments, and anticipating pleasant moments in the future. Savoring a pleasant experience involves becoming aware of that pleasure or of the positive emotions the participant feels at a given moment . For exaThe next slide is an example of a picture to imitate.The following slide allows participants to think about the exercise. Group leaders will help each participant to share their feelings during the exercise. The group leaders will also describe what they have felt, in order to help demonstrate ways of sharing experiences and guide participants in self-observation.Making the most of positive moments entails communicating and celebrating positive events with others. For example, participants are asked to describe positive events to one another through role playing. The next slides show a complete sequence of training with its experiential learning steps: concrete experience, reflective observation, abstract conceptualization, and active experimentation. During the concrete experience phase, participants experience the skill they are to be taught. During reflective observation phase, they consciously express and formulate the ingredients of that experience. During abstract conceptualization phase, the participants receive theoretical information about the skill they are being taught. Finally, during active experimentation phase, they practice the skill in their natural environment as homework. The homework is reviewed at the beginning of the next session.http://www.seretablir.net/outils-interventions/peps/.Anticipating pleasant moments involves imagining the sensations produced by positive future events. This strategy is meant to guide the participants through different positive feelings and emotions. It can engage their senses, for example, by imagining they are eating a smooth, shiny, crunchy, tasty, sweet-smelling fruit, or by anticipating the emotion produced and the physical sensations experienced upon the completion of a pleasurable physical or social activity. A simple homework task is assigned to be done between each session. For example, this could be choosing an image or an object that provokes a positive emotion or feeling in the participant, who must then bring it back and describe it to the group. The original French version of PEPS can be downloaded for free at Drug and psychological treatments for the negative symptoms of schizophrenia have shown poor clinical efficacy. Furthermore, they require lengthy therapeutic interventions involving highly skilled professionals. This paper presents a specific, short, easy to use, group-based intervention to improve pleasure, and motivation in schizophrenia. A more targeted syndrome approach was grafted to a model of the advancement of psychological therapies for delusions. The program targets apathy and anhedonia as they can be combined into a single reduced-experience syndrome. The program was built with regard to the specific deficits described in the literature on pleasure and motivation. The program was developed by beta-testing on health-care professionals and was improved according to the results of earlier tests. A pilot study was conducted with participants who met the ICD-10 criteria for schizophrenia or schizoaffective disorders . Thirty-Positive emotions program for schizophrenia was designed using a recovery-oriented approach rather than a deficit-centered approach. The deficits of pleasure, and above all of motivation, may be related to factors that were not selected as targets in the program. This could be mainly because the authors were looking for a rapid, targeted intervention on the diminished experience syndrome. For example, apathy is associated with poor performance on executive tests –66. CR hThe use of health-care professionals in the beta tests for developing the program may be questionable since they were not representative groups of people with schizophrenia. The high female-to-male ratio of the beta test samples did not fit with the high male-to-female ratio of patients with enduring schizophrenia . HoweverThe findings presented here indicate that PEPS is indeed a feasible intervention, and it was associated with an apparently specific reduction of anhedonia and apathy. However, these findings are limited by the absence of a control group and the fact that the rater was not blind to the treatment objectives. A randomized controlled study with blind raters is needed to assess more correctly the efficacy of PEPS.AN and JF, in equal measure, conceptualized this research and PEPS, acquired, analyzed, and interpreted the data, and drafted the first version of the manuscript. LF, IM, PG, and CB gave a substantial contribution to the analysis and interpretation of data and critically revised the article for important intellectual content. All the authors approved the final version for publication. All the authors agree to be accountable for all aspects of the work by ensuring that any questions related to its accuracy or integrity can be appropriately investigated and resolved.The authors declare that this research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.


In homozygous qkv mutant mice (qkv/qkv), the optic nerve expression levels of QKI-6 and 7, but not QKI-5 were reduced. In the retina of the mutant homozygote, QKI-5 levels were unchanged, and QKI-6 and 7 levels, already low, were also unaffected. We conclude that QKI is expressed in developing and adult Müller glia. QKI is additionally expressed in progenitors and in differentiating neurons during retinal development, but expression weakened or diminished during maturation. Among QKI isoforms, we found that QKI-5 predominated in the adult mouse retina. Since Müller glial cells are thought to share properties with retinal progenitor cells, our data suggest that QKI may contribute to maintaining retinal progenitors prior to differentiation into neurons. On the other hand, the expression of QKI in different retinal neurons may suggest a role in neuronal cell type specific fate determination and maturation. The data raises the possibility that QKI may function in retinal cell fate determination and maturation in both glia and neurons.Quaking (QKI), which belongs to the STAR family of KH domain-containing RNA-binding proteins, functions in pre-mRNA splicing, microRNA regulation, and formation of circular RNA. QKI plays critical roles in myelinogenesis in the central and peripheral nervous systems and has been implicated neuron-glia fate decision in the brain; however, neither the expression nor function of QKI in the neural retina is known. Here we report the expression of QKI RNA-binding protein in the developing and mature mouse retina. QKI was strongly expressed by Müller glial cells in both the developing and adult retina. Intriguingly, during development, QKI was expressed in early differentiating neurons, such as the horizontal and amacrine cells, and subsequently in later differentiating bipolar cells, but not in photoreceptors. Neuronal expression was uniformly weak in the adult. Among QKI isoforms , QKI-5 was the predominantly expressed isoform in the adult retina. To study the function of QKI in the mouse retina, we examined  QkI is a cloned gene lying immediately proximal to the deletion site in the quakingviable (qkv) mutation on mouse chromosome 17. The dysmyelination phenotype of qkv mutant mice is attributed to a deletion of a promoter element that drives QkI expression in myelinating glia. Cy. Cy38]. Since QKI was expressed in proliferating cells at early postnatal stages, we next examined its expression during embryonic stages. We examined the localization of QKI signals in the developing retina during embryonic stages by co-labeling retinal sections with antibodies against QKI and Ki67 . QKI sigMouse QKI has 3 isoforms resulting from splice variants QKI-5, -6, -7) , -6, -7 , we obtaqkv mutant to study the contribution of QKI in the retinal development. We first analyzed the expression levels of QKI isoforms in the qkv mutant retina by western blot using the optic nerve as a control (qkv/qkv mutant mice (q/q), the expression levels of QKI-6 and -7 were markedly reduced as compared to the qkv/wt control (q/w) due to defects of QKI in myelinating oligodendrocytes whereas the levels of QKI-5 were unaffected. In contrast, in the q/q retina, we did not detect reduction of the predominant QKI5 isoform or the weakly expressed QKI-6 and QKI-7 isoforms. The continued expression of QKI in q/q mouse retina did not recommend the qkv mutant for further studies on retinal anatomy and function. It is known that the reductions of QKI isoforms in q/q mouse are detected in oligodendrocytes but not astrocytes[qkv oligodendrocytes in which QKI-6 and QKI-7 are preferentially diminished, the genetic lesion in qkv mice does not affect QKI expression in the retina, which supports the hypothesis that the qkv deletion possibly affected a promoter and/or enhancer that drives expression of the qkI gene specifically in oligodendrocytes [Because QKI-deficient mice are embryonic lethal at an early stage, we attempted to use the  control . In the strocytes. Thus, udrocytes .In summary, our data show that QKI, an RNA-binding protein, was expressed predominately in Müller glia, and weakly in the early differentiating neurons, horizontal and amacrine cells in the mouse retina throughout late postnatal development . We did qkv mutant mice did not detect significant reductions of QKI proteins in the retina, however, there were no significant reductions of QKI isoforms including QKI-5 in the q/q mutant retina compared with the q/w control. We also did not see any changes in morphology and cell specific markers in q/q mutant retinas by immunohistochemistry (data not shown). In contrast, QKI-6 and -7, but not QKI-5, were reduced in the q/q mutant optic nerve demonstrating an effect of the qkv mutation. It is reported that QKI is required for oligodendrocyte cell fate and myelination [Among QKI isoforms, we found that QKI-5 predominates in the adult mouse retina Figs  and 2E. lination ,42,43, alination ,10. Sinclination , conditiS1 FigImmunodeletion assays were performed at P5 (A) and P9 (B) retina. Far left is control without primary antibody. Immunostaining with anti-QKI antibody showed strong signals (middle left). The anti-QKI antibody immunodepleted by incubation with GST–QKI (far right) significantly decreased the signals, whereas the anti-QKI antibody immunodepleted with GST showed strong signals by immunostaining (middle right). Scale bar is 50 μm.(TIF)Click here for additional data file.S1 TableParentheses show reference numbers.(TIF)Click here for additional data file.


Fit and Strong! began in 1998. It grew out of the Hughes doctoral dissertation many years ago that examined the impact of a model long-term home care program for older adults. We learned at that time (1981) that arthritis was the most common chronic condition reported by homebound clients and the condition that was most frequently cited by them as interfering greatly with their function. To learn more about this story, we obtained funding from the National Institutes of Health (NIH) to conduct a prospective, longitudinal study in Chicago of 600 seniors who were unselected for presence of arthritis at baseline. We found again that arthritis was the most common condition reported and the number one cause of disability .We conducted the longitudinal study in order to understand the links between presence of OA and development of disability. Once we understood the causal chain, it was clear that our next step should be the development of an intervention to interrupt it. We examined the OA physical activity literature and found that people with OA have two problems. They are aerobically de-conditioned and have weaker muscles than age-matched controls , 4. PeopThe resulting program, Fit and Strong!, consists of three 90-min sessions per week over 8 weeks. The first hour of each session is devoted to exercise  and the last 30 min is devoted to a structured health education/group problem solving curriculum. We tested the program in an efficacy trial that found differential benefits in the treatment group on physical activity, self-efficacy for exercise, and lower extremity stiffness at 8 weeks. At 6 months, those gains were maintained and we saw additional benefits on self-efficacy for adherence to physical activity over time and lower extremity pain. Several of these gains were maintained at 12 months with large effect sizes .The efficacy trial sought to demonstrate that a structured program of aerobic exercise and resistance training would not harm persons with painful lower extremity joints. The program was delivered by trained physical therapists who had experience working with persons with OA, but this was an expensive model for translation. By this time, we had obtained funding to test different ways of bolstering maintenance of physical activity after Fit and Strong! ends. This effectiveness trial was conducted on the south side of Chicago, enabling us to expand the reach of the program into largely African American communities. We used this study as an opportunity to conduct a natural experiment. We used the physical therapist instructor model with the first 200+ enrollees and then taught the remaining 300 enrollees using certified exercise instructors. Outcomes were very strong at 8 weeks and 6 months with both types of instructors, attendance was high and participant evaluations glowing . TherefoWe subsequently received funding from the Centers for Disease Control and Prevention (CDC) to test the translation of Fit and Strong! in partnership with Area Agencies in Aging in Illinois and North Carolina. This work with community partners enabled us to develop a license and fee structure, fine tune Lead , Master, and Instructor trainings, and develop many other types of materials including a program implementation guide and participant and instructor manuals. We also developed an interactive website that enables us to track participant attendance, conduct program evaluations, and collect a reduced set of outcome measures for all participants at baseline and immediately post-program. The outcomes now tracked across sites include: body mass index (BMI), lower extremity joint pain and stiffness, self-efficacy for exercise, engagement in physical activity, and energy/fatigue. We also learned along the way that some sites find it more practical to offer the program two times per week. We now allow providers to make this adaptation to the program when necessary as long as they cover the full complement of 24 sessions, which extends the program to 12 weeks in length.More recently, we developed and tested a new Hispanic version of the program, ¡en Forma y Fuerte!, in Chicago and Phoenix. That pilot taught us that many older Latinos who have immigrated to the U.S. have low levels of formal education. Our participant manuals are written for eighth grade literacy levels. We are now revising the Hispanic Manual to a fourth grade level and will work with instructors to use pictures and stories to get points across. We obtained participant baseline, 8-week and 6-month outcomes for this pilot. Preliminary analyses show strong results at both time points and we plan to publish the findings very soon .There is currently no process in place for providers to help graduates of an evidence-based program move on to a different, complementary evidence-based program. For this reason, we obtained foundation funding to examine initial steps that could be taken to bundle Fit and Strong! with other evidence-based programs like Matter of Balance and CDSMP. This lay leader effort is training people who have already been trained in an evidence-based program and layering the Fit and Strong! training on top. Currently, we are implementing the lay leader model in IL, TX, and MI, USA. Sites that are using the lay leader approach continue to use our interactive website to enter pre- and post-participant outcome assessments and attendance data. We will be analyzing the outcome data soon to learn whether participant outcomes with this new instructor model are as strong as outcomes seen with the physical therapist and certified exercise instructor models. Anecdotal feedback from participating sites has been very positive.Finally, while offering the program on the south side of Chicago we were asked by participants to include more information in the Fit and Strong! participant manual about diet/weight management. We researched this issue, learned about the strong relationship between overweight/obesity and knee OA, and obtained funding from the National Institute on Aging to compare the effectiveness of customary Fit and Strong! to that of a new version, Fit and Strong! Plus, that includes both physical activity and an explicit dietary change/weight management component. The new program also has 24 sessions, but the health education curriculum has been adapted to include dietary behavior change information intended to facilitate participant weight loss. Early returns from this study have been quite positive . We are To conclude, the enduring hallmark of an evidence-based program is the capacity to produce the same, consistent results across different populations, geographic sites, and instructors. Fit and Strong! has demonstrated the capacity to produce nearly identical participant outcomes across six different evaluations with Caucasian, African American, and Hispanic participants; across sites in IL, MI, NC, TX, and AZ; and with three different types of instructors – physical therapists, certified exercise instructors, and experienced evidence-based program lay leaders. Our program that combines structured physical activity with health education for building self-efficacy and behavior change is starting to demonstrate similar positive outcomes with additional clinical populations like cancer survivors and is being tested with persons with symptoms of depression. We are also very excited about the potential contribution of the new Fit and Strong! Plus program to not only promote a physically active lifestyle but also simultaneously promote healthy eating and weight management. As the foregoing demonstrates, the chapter is still very much being written on Fit and Strong! adaptations and outcomes, so stay tuned for future developments!The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.This paper is included in the Research Topic, “Evidence-Based Programming for Older Adults.” This Research Topic received partial funding from multiple government and private organizations/agencies; however, the views, findings, and conclusions in these articles are those of the authors and do not necessarily represent the official position of these organizations/agencies. All papers published in the Research Topic received peer review from members of the Frontiers in Public Health  panel of Review Editors. Because this Research Topic represents work closely associated with a nationwide evidence-based movement in the US, many of the authors and/or Review Editors may have worked together previously in some fashion. Review Editors were purposively selected based on their expertise with evaluation and/or evidence-based programming for older adults. Review Editors were independent of named authors on any given article published in this volume.


Despite declines over the past few decades, the United States has one of the highest rates of teen pregnancy compared to other industrialized nations. American Indian youth have experienced higher rates of teen pregnancy compared to the overall population for decades. Although it's known that community and cultural adaptation enhance program effectiveness, few teen pregnancy prevention programs have published on recommendations for adapting these programs to address the specific needs of Northern Plains American Indian youth. We employed a mixed-methods analysis of 24 focus groups and 20 interviews with a combined total of 185 urban and reservation-based American Indian youth and elders, local health care providers, and local school personnel to detail recommendations for the cultural adaptation, content, and implementation of a teen pregnancy prevention program specific to this population. Gender differences and urban /reservation site differences in the types of recommendations offered and the potential reasons for these differences are discussed. Although adolescents of all races and ethnicities engage in behaviors such as unprotected sex and substance use that increase their risk for sexually transmitted infections (STIs) and teen pregnancies , a peer education program developed for youth in rural Georgia . This comprehensive, skills-based program has been modified from its original version to better address the needs of AI/AN youth. The curriculum identifies and incorporates cultural strengths and traditional teachings coupled with the recognition that AI/AN youth face many of the same challenges as mainstream youth . Pre and post survey data from Native STAND indicates that student participants showed increases in sexual health communication with peers, knowledge of reproductive health and STI/HIV prevention, intention to use condoms to avoid pregnancy and STIs, and condom self-efficacy . These findings indicate the necessity of prevention programs to be responsive to community and cultural needs while simultaneously focusing on sexual behavior, including contraceptive use.Another evidence-based curriculum, the Discovery Dating curriculum, emerged as a result of the needs expressed by women of the Oneida Indians of Wisconsin reservation and is based on AI/AN teachings, traditions, and cultural norms as the foundation of healthy relationship development and sexual abstinence. Discovery Dating is a five-year teen pregnancy prevention program that was implemented with eighth-grade students attending a rural tribal school. Study findings indicate fewer pregnancies and higher rates of condom use among program participants compared to the control group; further highlighting the potential impact of culturally based approaches to support sexual health and reduce teen pregnancies .Live It! program, another example of a culturally tailored, teen pregnancy prevention and sex education program, has two versions of the curriculum, one for AI/AN youth ages 12–18 and one for parents, guardians, and other adults who work with AI/AN youth. The program was developed by the Division of Indian Work in Minneapolis, MN with the intention that the program could be adapted by tribes. According to The National Campaign to Prevent Teen and Unplanned Pregnancy (2009), the program has been implemented with more than 700 youth and 90 adults in more than 60 states. Pre/post test results suggest the program has increased knowledge among program participants about puberty and healthy relationships.The As seen in these examples, a number of teen pregnancy programs have achieved measurable successes. However, various problems with disseminating such “model practices” within AI/AN communities have also been identified. In their response to the evidence-based program mandate, Walker and Bigelow  proposedGiven this need for teen pregnancy prevention programs to be responsive to the specific cultural needs and contexts of AI/AN communities, it is important that researchers and practitioners understand the needs and context of the communities and youth with whom they work. In our review of the literature, the types of pregnancy prevention programs and suggestions for cultural tailoring that are of interest to urban and reservation-based AI/AN youth were rarely specified with a couple of exceptions. One of these exceptions was a study conducted by Garwick, Rhodes, Peterson-Hickey, and Hellerstedt (2008), which describes the various teen pregnancy prevention recommendations of 148 AI/AN youth living in the Minneapolis/St. Paul metropolitan area through the use of 20 focus groups with girls and boys aged 13–18 years. Content analyses of the focus group data revealed the following themes: “show the consequences of adolescent pregnancy; enhance and develop more pregnancy prevention programs for AI/AN youth in schools and community-based organizations; improve access to contraceptives; discuss teen pregnancy with AI/AN youth; and use key messages and media to reach Native youth” .Another exception was a study by Rushing and Stephens  using daGiven that previous research indicate that Northern Plains AI/AN youth face intense pressures to engage in sex at young ages, as illustrated by Kaufman et al. , coupledThe purpose of the present study is to provide community-driven suggestions for the design and implementation of a teen pregnancy prevention program for urban and reservation Northern Plains AI youth. Determining urban and reservation site differences in program recommendations was also a primary focus of this study. Understanding the variations in the needs and desires of these populations is beneficial in determining how to best tailor the program to fit the specific needs of these populations. In addition, particular attention was paid to understanding the gender differences in program recommendations to provide insight into the variations in the priorities of females versus those of males, which can be used to shed some light on how to better modify prevention efforts to address the specific needs of both genders.Throughout the development of this project, we used a CBPR approach, which can be defined as a partnership approach to research which equitably involves community members and researchers in all stages of the research process by means of contributing expertise and shared decision-making and responsibilities, including the selection of appropriate research design and methodology  with Northern Plains AI youth (both parents and nonparents) and elders and 20 semi-structured interviews (10 per site) with health care providers and high school personnel. A total of 185 community members participated in this study; however, two female parents from the reservation site who participated in the focus group did not complete the demographics survey. Of these participants, 90 were recruited from the reservation site and 95 were recruited from the urban site see . Local cData collection began during fall 2012 and continued through the winter and spring 2013. The focus groups and interviews were conducted in private rooms at local community health service buildings or libraries at each site. Focus groups included 5–11 participants per group, and groups were stratified by age, gender, and parental status. Written consent or assent was obtained from all participants, and parental consent was obtained for participants younger than 18 years of age. Participants were offered a $40 gift card to a retail store for their participation in the interview or focus group. The interviews and focus groups were tape-recorded and transcribed verbatim.Focus group and interview questions focused on soliciting recommendations for getting youth interested in participating in a teen pregnancy prevention program, program content, and where and when to host the program. In addition, interviewees were asked what the community's role is, if any, in preventing teen pregnancy. Responses to these questions contributed to detailed recommendations on how to best tailor a teen pregnancy prevention program to fit the needs of urban and reservation-based Northern Plains AI youth.Focus group and interview transcripts were stored and analyzed using the Qualitative Solutions and Research International NVivo 10 software program NVivo, . As recoThe development of the codebook was guided by recommendations from MacQueen, McLellan, Kay, and Milstein (1998), in which codes were operationalized through coding definitions and coding decision rules in an iterative process involving multiple coding manual revisions. This process involved the systematic review of codes by two independent coders to determine the utility of the codes and consistency in their application. Specific sections of unique text were coded by the two coders independently, and inconsistencies were reviewed by the coders and the principal investigator. Disagreements among coders with respect to the interpretation and application of codes and/or coder errors were identified and discussed until a consensus was reached on how to best define codes and set parameters for coding text. In such cases, the codebook was clarified as needed. All previously coded text was then reviewed and, if necessary, recoded to maintain consistency with revised definitions and/or application parameters. This process ultimately resulted in 42 coding categories, which is not unusual given the amount of data gathered by means of the 20 interviews and 24 focus groups.p <.05.After the themes were determined through the extensive qualitative analysis described above, frequencies were calculated for each theme and subsequent subthemes using SPSS version 20. Chi-square analyses were used to determine whether there were significant differences between the expected frequencies and the observed frequencies in the distribution of subthemes  between urban and reservation sites and females and males. The number of categories selected for this test was restricted to assure that less than 20% of the minimum expected cell frequency was less than 5. The traditional Bonferroni method of post-hoc analysis was also run to test for which specific differences contributed to the overall difference observed in the chi-square tests. This particular method of post-hoc analysis was selected given its ability to make multiple comparisons while simultaneously correcting for the significances of each comparison. Both chi-square and post-hoc results were considered significant when Another important piece of the qualitative data analysis was the calculation of inter-rater reliability. Two coders separately coded a random selection of 300 lines from the transcripts using the final draft of the codebook as recommended by Lombard, Snyder-Duch, and Bracken (2010). The kappa value was considered “substantial” (0.61 to 0.80) using the benchmarks set by Landis and Koch .Additional validity and reliability of the qualitative data were established through various methods. For example, ontological appropriateness and contingent validity were strengthened through the use of a diverse range of participant perspectives to describe the reality of teen pregnancy among AIs . The top five categories (detailed further below) were testimonials/guest speakers, cultural education, hands-on activities, sex/reproductive health education, and teen pregnancy impact. A summary of recommendations for a strengths-based approach to curriculum design is also included even though this recommendation was less frequent than a number of other categories given that such suggestions were characteristic of differences in program recommendations by site.When asked what participants would like to see included in a teen pregnancy prevention program, responses fell within 21 categories of suggested program content and activities (see n = 61) primarily from current or former teen parents. A young, urban father who suggested that a teen parent come in as a guest speaker commented, “Tell them their own experiences, bad or good, or good or bad, you know. Especially like the bad experiences, I think that would have a lot of effect on the youth… .” Other suggestions for testimonials and guest speakers included storytelling. A reservation elder expressed his want for storytelling as follows:I think one of the things that, I guess, I would like to see, or have seen, would be our older elders to share their stories with not only their grandchildren, but maybe within our tribal school system, because there's a lot of knowledge there. And these kids, if you share a story with them about your personal life, a lot of times they’ll open up to you. And I think our elders need to do that.The most frequent program content and activities suggestion was to include testimonials and/or guest speakers  through the incorporation of traditional, cultural teachings. It should be noted that six responses articulated hesitations about including cultural education in the program, all of which were from reservation study participants, either because some youth are not involved in traditional ceremonies, are not sure how cultural education relates to sexual decision-making, or because the school system may resist. However, these responses were coded under the overall cultural education category.The second most common recommendation was for program content to have a cultural focus  summed up her desire to include culture in the following way:sic] ways that we taught, you know, peoples [sic] who, our women and our men, what their roles and responsibilities were.”A similar sentiment was expressed by a reservation elder in her explanation for why including cultural education is important. She said, “Because within our ceremonies and our culture, you know, there was  like how hard it would be to stay in sports with a kid.” Similarly, one urban school personnel discussed how keeping youth actively involved in various activities might be an effective risk-taking behavior prevention method. She said, “… I guess that's another thing, kind of, you know, with just that prevention piece, is keeping kids active so they’re not having nothing [sic] to do and searching for things and [sic] that they maybe shouldn't be involved in.” Another way that incorporating hands-on activities was mentioned was in terms of making the program more appealing and fun for youth. This sentiment was reflected in a comment by a reservation elder. He stated, “First of all, you have to bring it down to their level. Make it interesting. Make it fun.”The third most common suggestion was to include hands-on activities in the program (n = 41). This recommendation often emphasized the need for providing youth with accurate, comprehensive information about sex and reproductive health so as to provide youth with the knowledge and the resources to make healthy, informed sexual decisions. An urban health care provider voiced this concern in the following way, “Then there's the blatant reality that kids need to know what their options are and certainly the health risks of STDs and everything. So I believe, totally, in being very open with kids… .” Respondents often indicated that conversations with youth about sex, regardless of whether these conversations are initiated by parents, teachers, or health care providers, should be open and honest. As one reservation health care provider stated, “I think having a conversation and listening to, and just being able to talk openly with the younger people about it. Just ask the questions, not being ashamed or afraid.”The fourth most frequently mentioned suggestion was to include sex/reproductive health education (n = 34). Similar to suggestions for having teen parents as guest speakers, recommendations that fell under this category often reflected the need for program content to include factual information which relate to lived experiences reflecting the potential hardships of teen parenting. As one urban male youth (nonparent) stated, “Yeah, honestly, that's the way I really think kids need to be taught these days. Get it in their face. Be straight up. Say it how it is. Tell ‘em [sic] how it is to struggle with a kid… .” In her suggestion to highlight the financial responsibility of raising a child, one female youth living on a reservation commented, “And I think, like, if teens knew the cost of raising a baby, they would be more careful or, I don't know, more interested in preventing themselves from having a baby.” In addition to including the cost of raising a child, other suggested impacts included: how a person's body changes throughout pregnancy, labor and delivery, potential difficulties in completing high school and pursuing postsecondary education, and the daily challenges of raising a child.The fifth most recurrent suggestion for program content and activities was to highlight the potential impact of teen pregnancy on a person's life . Specifically, post-hoc analyses comparing column proportions and adjusting the p values (Bonferroni method) revealed a significant difference in the frequency in which recommendations for including sex/reproductive health education were given by residency, with such recommendations occurring more often among the urban participants (27 vs. 14). A difference was also observed in the frequency in which recommendations for incorporating hands-on activities and utilizing a strengths-based approach were given by residency, with both suggestions being more frequent among reservation-based participants . There was no significant difference between the remaining program content categories by area of residence.To perform a more in-depth analysis of the data patterns, a mixed methods approach was used; namely, chi-square independent tests were run to test for significant differences between program recommendations and residence in an urban versus reservation area. A significant overall difference was found between program content and activities (top 12 subcategories) and area of residence . Notably, Bonferroni post-hoc analyses revealed a significant difference in the frequency in which recommendations for including sex/reproductive health education, cultural education, empowerment/self-esteem, and having one-on-ones were given by gender, with a higher frequency for all among females . A difference was also observed in the frequency in which recommendations for incorporating hands-on activities were given by gender, with a higher occurrence of these recommendations among males (23 vs. 20). Although this difference might appear minimal at first glance, it should be noted that, overall, there were 230 program content and activities suggestions from females versus 93 from males.Chi-square independent tests were also run to test for significant differences between program recommendations and gender. Analyses revealed a significant overall difference between program content and activities (top 11 subcategories) and gender , which reveal that females often felt pressured by family to have children at a young age and often felt obligated to engage in sexual intercourse “to please their boyfriend, even if they don't want to” (p. 812). Although contraception use is often seen as the female's responsibility among both males and females alike  is unusual in qualitative research. With a sizable dataset such as this, analyses were able to quantify the qualitative data to make statistical comparisons. The use of a mixed methods approach has proven to be beneficial in describing the program recommendations of study participants while also determining the specific site and gender differences in these recommendations. The use of a mixed methods design revealed both in-depth, contextualized program recommendations and statistically significant comparisons between participants based on the outcomes of interest. Determining site differences in program recommendations was important for understanding the variations in the needs and wants of these populations. In addition, understanding the gender differences in program recommendations provides insight into the priorities of females versus those of males, which can be used to better modify prevention efforts to address the specific needs of both genders.In relation to the research methods used in this particular study, such a considerable sample size , storytelling, and the application of traditional Northern Plains AI values  to healthy decision making and discussions of local coming-of-age ceremonies. In adherence with suggestions to include testimonials, guest speakers, and to highlight the impact of teen pregnancy, vignettes are included to incorporate the wisdom of tribal elders and a former AI teen parent is an invited guest speaker to reflect on their experiences and struggles as a teen parent. Given the differences in the recommendations between urban and reservation community members, there are variations by site in determining which lessons are essential to program delivery and dosage, with those lessons relating to sex/reproductive health content being more of a focus at the urban site, while those lessons utilizing experiential learning techniques being more critical at the reservation site.how knowledge is acquired is as important, if not more important, than the knowledge gained, especially in efforts to eliminate or reduce health disparities. Therefore, community involvement and cultural consultation are utilized throughout program and curriculum development and implementation to assure that traditional learning styles are being implemented accurately and appropriately. Given that the development of this program is guided by community-driven recommendations, the project will continue to involve AI community members, and we anticipate that the My Journey curriculum will have a sustained impact on Northern Plains AI youth.Moreover, the findings highlight the importance of taking into account indigenous methodologies and ways of knowing. As illustrated by Cochran et al. , how knon of the various coding categories. Future research could address these differences between the perceived need and desired characteristics of a teen pregnancy prevention program based on age, parental status, and community role. In addition, this research could be extended to other tribes and AI populations to explore differences in sexual decision-making and recommendations for teen pregnancy prevention efforts as they relate to specific AI cultures, gender norms, and variations in cultural assimilation.Participants in the focus groups and many of the key informant interviews were primarily Northern Plains AIs; therefore, the results cannot be generalized to all AIs. Furthermore, quantitative analyses could not be run to compare differences in program recommendations between youth parents and nonparents, elders, school personnel, and health care providers because of the low Our research advances the literature by providing detailed recommendations for the development of a teen pregnancy prevention program specific to the wants and needs of urban and reservation Northern Plains AI youth. The findings outlined in this article provide an in-depth look at how teen pregnancy prevention efforts might tailor a program to fit the wants and needs of these populations, while also outlining potential reasons for observed differences in the recommendations offered between urban and reservation sites and between females and males. Given that little is known about how to best tailor a teen pregnancy program to fit the cultural needs of these populations, this contribution adds to the literature by detailing the various community-driven suggestions for how this might be done. It also highlights the desirability of a culturally grounded teen pregnancy prevention program among both urban and reservation-based Northern Plains AIs.The authors thank Dr. Renee Seiving, Melissa Huff, Char Green, Jen Prasek, Dr. Paul Thompson, Ashley Miller, Noelani Villa, Donna Keeler, Reggan LaBore, Kathy White, Cassandra Crazy Thunder, Tonya Belile, Chad Birger, and Ashley Schwab for their contributions to this project.The authors disclosed receipt of the following financial support for the research, authorship, and or publication of this article: This work was supported by the National Institutes of Health, National Center on Minority Health and Health Disparities [P20MD001631-06]. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Center on Minority Health and Health Disparities or the National Institutes of Health (NIH).