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Severe acute malnutrition (SAM) remains a major global public health problem. SAM cases are treated using ready‐to‐use therapeutic food (RUTF) at a dosage of ∼200 kcal/kg/day per the standard treatment protocol (STD). Emerging evidence on simplifications to the standard protocol, which among other adaptations, includes reducing the daily RUTF dosage, indicates that it is effective and safe for treating children with SAM. In response to a foreseen stock shortage of RUTF, the government of Afghanistan endorsed the temporary use of a modified treatment protocol in which the daily RUTF dosage was prescribed at 1000 kcal/day (irrespective of body weight) until the child achieved moderate acute malnutrition status (weight‐for‐height z‐score ≥ −3 or mid‐upper arm circumference [MUAC] ≥ 115 mm), at which point 500 kcal/day was prescribed until cured (modified treatment protocol [MTP]). In this paper, we report the results of this nonweight‐based daily RUTF dosage experience. Data of 2042 children with SAM, treated using either the STD protocol (n = 269) or the MTP protocol (n = 1773) from August 2019 to March 2021 in five provinces, were analyzed. The per‐protocol analyses confirmed noninferiority of MTP protocol when compared to STD protocol for recovery rate [93.3% vs. 90.2%; ∆ (95% confidence interval, CI) = 3.1 (−0.9; 7.2) %] and length‐of‐stay [82.6 vs. 75.6 days; ∆ (95% CI) = 6.9 (3.3; 10.5) days], considering the margin of noninferiority of −10% and +14 days, respectively. Weight gain velocity was smaller in the MTP protocol group than in the STD protocol group [3.7 (1.7) vs. 5.2 (2.9) g/kg/day; ∆ (95% CI) = −1.5 (−1.8, −1.2); p < 0.001]. The STD group had a significantly higher mean than the MTP group for absolute MUAC gain [∆ (95% CI) = 1.7 (1.0; 2.3) mm; p < 0.001] and the MUAC velocity [∆ (95% CI) = 0.29 (0.20; 0.37) mm/week; p < 0.001]. Our results confirm the noninferiority of a nonweight‐based daily dosage and support the endorsement of this modification as an alternative to the standard protocol in resource‐constrained contexts. Key messages: More evidence supporting the use of the nonweight‐based daily ready‐to‐use therapeutic food (RUTF) dosage for treating uncomplicated severe acute malnutrition (SAM), in specific contexts, is needed.Our real‐world prospective nonrandomized study showed that the fixed nonweight‐based daily RUTF dosage protocol is as effective as the standard weight‐based protocol for treating uncomplicated SAM in children <5 in the Afghanistan context.Our findings support the reflection of a nonweight‐based daily RUTF dosage in resource‐constrained contexts in national and global policies and guidelines to improve coverage of all children in need of treatment. [ABSTRACT FROM AUTHOR]

Background: As part of a multifaceted approach to patient and public involvement and engagement (PPIE), alongside traditional methods, a closed Facebook group was established to facilitate PPIE feedback on various aspects of a project that used video‐recording to examine risk communication in NHS Health Checks between June 2017 and July 2019. Objective: To explore the process and impact of conducting PPIE through a closed Facebook group and to identify the associated benefits and challenges. Methods: Supported by reflections and information from project meetings used to document how this engagement informed the project, we describe the creation and maintenance of the Facebook Group and how feedback from the group members was obtained. Facebook data were used to investigate levels and types of engagement in the closed Facebook group. We reflect on the challenges of using this method of engaging the public in health research. Results: A total of 289 people joined the 'Risk Communication of Cardiovascular disease in NHS Health Checks' PPIE closed Facebook group. They provided feedback, which was used to inform aspects of the study, including participant‐facing documents, recruitment, camera position and how the methodology being used (video‐recorded Health Checks and follow‐up interviews) would be received by the public. Discussion: Using a closed Facebook group to facilitate PPIE offered a flexible approach for both researchers and participants, enabled a more inclusive method to PPIE (compared with traditional methods) and allowed rapid feedback. Challenges included maintaining the group, which was more labour intensive than anticipated and managing members' expectations. Suggestions for best practice include clear communication about the purpose of the group, assigning a group co‐ordinator to be the main point of contact for the group, and a research team who can dedicate the time necessary to maintain the group. Conclusion: The use of a closed Facebook group can facilitate effective PPIE. Its flexibility can be beneficial for researchers, patients and public who wish to engage in the research process. Dedicated time for sustained group engagement is important. Patient or Public Contribution: Patient representatives were engaged with the development of the research described in this paper and a patient representative reviewed the manuscript. [ABSTRACT FROM AUTHOR]

Aim: This study aimed to identify and map the production of knowledge on non‐pharmacological strategies to reduce stress and anxiety in patients undergoing endovascular procedures. Design: Scoping review. Methods: The review was performed using the PRISMA‐ScR guidelines. The searches were conducted in Scopus, PubMed, Web of Science, Wiley Online Library, BVS/BIREME, Lilacs, Gale Academic OneFile, SciELO, Cochrane Library, CAPES Catalog of Dissertations and Theses, Oswaldo Cruz Foundation Portal of Theses and Dissertations, and Theses and Dissertations from Latin America. Results: Twenty‐two articles were selected. The articles were published from 2001 to 2022, mostly in Iran, and there was a predominance of randomized clinical trials. The Spielberger State‐Trait Anxiety Inventory was the most used instrument. The findings indicated that music therapy, educational guidelines or videos on the procedure, massage, psychological preparation and aromatherapy were the main non‐pharmacological therapies used to reduce anxiety and stress in patients undergoing vascular procedures. [ABSTRACT FROM AUTHOR]

Although sucrose is widely administered to hospitalized infants for single painful procedures, total sucrose volume during the entire neonatal intensive care unit (NICU) stay and associated adverse events are unknown. In a longitudinal observation study, we aimed to quantify and contextualize sucrose administration during the NICU stay. Specifically, we investigated the frequency, nature, and severity of painful procedures; proportion of procedures where neonates received sucrose; total volume of sucrose administered for painful procedures; and incidence and type of adverse events. Neonates <32 weeks gestational age at birth and <10 days of life were recruited from four Canadian tertiary NICUs. Daily chart reviews of documented painful procedures, sucrose administration, and any associated adverse events were undertaken. One hundred sixty‐eight neonates underwent a total of 9093 skin‐breaking procedures (mean 54.1 [±65.2] procedures/neonate or 1.1 [±0.9] procedures/day/neonate) during an average NICU stay of 45.9 (±31.4) days. Pain severity was recorded for 5399/9093 (59.4%) of the painful procedures; the majority (5051 [93.5%]) were heel lances of moderate pain intensity. Sucrose was administered for 7839/9093 (86.2%) of painful procedures. The total average sucrose volume was 5.5 (±5.4) mL/neonate or 0.11 (±0.08) mL/neonate/day. Infants experienced an average of 7.9 (±12.7) minor adverse events associated with pain and/or sucrose administration that resolved without intervention. The total number of painful procedures, sucrose volume, and incidence of adverse events throughout the NICU stay were described addressing an important knowledge gap in neonatal pain. These data provide a baseline for examining the association between total sucrose volume during NICU stay and research on longer‐term behavioral and neurodevelopmental outcomes. [ABSTRACT FROM AUTHOR]

Background: Evidence shows that online interventions could prevent depression. However, to improve the effectiveness of preventive online interventions in individuals with subthreshold depression, it is worthwhile to study factors influencing intervention outcomes. Outcome expectancy has been shown to predict treatment outcomes in psychotherapy for depression. However, little is known about whether this also applies to depression prevention. The aim of this study was to investigate the role of participants' outcome expectancy in an online depression prevention intervention. Methods: A secondary data analysis was conducted using data from two randomised‐controlled trials (N = 304). Multilevel modelling was used to explore the effect of outcome expectancy on depressive symptoms and close‐to‐symptom‐free status postintervention (6–7 weeks) and at follow‐up (3–6 months). In a subsample (n = 102), Cox regression was applied to assess the effect on depression onset within 12 months. Explorative analyses included baseline characteristics as possible moderators. Outcome expectancy did not predict posttreatment outcomes or the onset of depression. Results: Small effects were observed at follow‐up for depressive symptoms (β = −.39, 95% confidence interval [CI]: [−0.75, −0.03], p =.032, padjusted =.130) and close‐to‐symptom‐free status (relative risk = 1.06, 95% CI: [1.01, 1.11], p =.013, padjusted = 0.064), but statistical significance was not maintained when controlling for multiple testing. Moderator analyses indicated that expectancy could be more influential for females and individuals with higher initial symptom severity. Conclusion: More thoroughly designed, predictive studies targeting outcome expectancy are necessary to assess the full impact of the construct for effective depression prevention. Patient or Public Contribution: This secondary analysis did not involve patients, service users, care‐givers, people with lived experience or members of the public. However, the findings incorporate the expectations of participants using the preventive online intervention, and these exploratory findings may inform the future involvement of participants in the design of indicated depression prevention interventions for adults. Clinical Trial Registration: Original studies: DRKS00004709, DRKS00005973; secondary analysis: osf.io/9xj6a. [ABSTRACT FROM AUTHOR]

Background and objective: End‐stage renal disease (ESRD) affects a multitude of aspects in the patient's daily life, often entailing their own involvement in various aspects of the treatment. Although patient participation is a core health‐care value, what the concept signifies is not yet fully known. The purpose of this paper is to conceptualize patient participation in dialysis care, depicting patients' and health‐care professionals' perspectives. Design: This explorative study employed qualitative interviews and content analysis. Setting and participants: Seven focus group discussions engaging 42 key informants were performed, including patients, staff and managers with experience of dialysis care. Results: In dialysis care, patient participation connotes a sharing of information and knowledge, the learning of and planning of care, including partaking in shared decisions with regards to treatment and management, and being involved in the management of one's own health‐care treatment and/or self‐care activities. Although these attributes were illustrated by all stakeholders, their significance varied: patients suggested that their preferences regarding primary aspects of participation vary, while staff considered patients' performance of dialysis to be the ultimate form of participation. Further, while patients considered multiple ways to execute participation, staff suggested that aspects such as sharing information were a route to, rather than actual, involvement. Conclusions: Without a common understanding to denote the idea of patient participation, staff and patients are exposed to a potential deficit in terms of facilitating patient participation in everyday encounters of dialysis treatment. Further studies and means to serve a mutual understanding are needed. [ABSTRACT FROM AUTHOR]

Background and Objective: To improve quality, child and adolescent mental health services (CAMHS) are expected to quantify families' views on healthcare with user satisfaction measures. As little is known about what influences satisfaction in CAMHS, this study aimed to examine predictors of adolescents' and parents' user satisfaction. Methods: Data from 231 adolescents and 495 parents in treatment at an outpatient clinic who returned a user satisfaction measure, the Experience of Service Questionnaire (ESQ), was analyzed. Registry data on background, clinical and service characteristics were predictors for the ESQ factors general satisfaction, satisfaction with care and satisfaction with environment. Results: In regression models, satisfaction with care for adolescents (r2 =.12) was significant and was predicted by low parent‐self‐reported mental health burden and low clinician‐rated overall symptom burden at intake. For parents, regression models for general satisfaction (r2 =.07), satisfaction with care (r2 =.06) and satisfaction with environment (r2 =.08) were significant. Parents general satisfaction was predicted by higher levels of hyperactivity, less family stress and longer travelling distances to the service. Satisfaction with care for parents was predicted by higher levels of hyperactivity at intake and longer travelling distances. Satisfaction with environment for parents was more likely if the adolescents was a boy, with low levels of family stress and longer travelling distances. Conclusion: Predictors for adolescent and parent user satisfaction in CAMHS differ. Hence, to improve quality CAMHS should enhance focus on collaborative practice with parents, and person‐centred care for adolescents with moderate to severe mental health illness. Patient or Public Contribution: Representatives from the hospitals' youth panel and the non‐governmental organization called The Change Factory have been consulted regarding study design and results. [ABSTRACT FROM AUTHOR]

According to the UN Convention on the Rights of the Child (UNCRC), children have the right to be involved in decisions about medical procedures affecting them. However, research has shown that healthcare professionals sometimes find this difficult to achieve and those procedures then are performed against the will of the child. The aim was to illuminate restraint from the perspective of children's and young people's experiences of feeling forced during medical procedures. Following the phenomenological hermeneutic method, a secondary qualitative analysis of narrative data from four datasets collected between 2001 and 2020 was performed. Twelve children and young people aged 6–19 years (three male, nine female) from central and northern Sweden narrated their experiences of restraint related to medical procedures in nine narrative interviews and three short written narratives. The analysis revealed that it hurts to get forced, this being illustrated in six themes: bodily misery, emotional rebellion, feeling disregarded, physically limited, desiring escape, and leaving deep traces. From the perspective of children and young people, restraint was interpreted with inspiration from the philosopher Michel Foucault, as being overpowered – not voluntary submission but offering resistance – and according to the theory of caring and uncaring, a relationship in which the healthcare professional is perceived as indifferent to the patient as a person. In conclusion restraint hurts and means powerlessness to the child, leaving deep traces that remain for a long time. The findings call the healthcare profession to take action to support children's self‐determination, participation, and integrity in healthcare. How children experience restraint in healthcare merits further investigation from the children's own perspective. [ABSTRACT FROM AUTHOR]

Aim: The aim of the study was to identify interventions to promote mobility that has an impact on the quality of life of people living in nursing homes and assisted living facilities. Design: The design of the study was a systematic review. Methods: The search was performed in September 2021 in the databases PubMed, Epistemonikos and the Cochrane Library for studies published between 2010 and 2021 in the German or English language. Results: Four studies identified improvements in mobility and quality of life. Nine of the ten included studies showed impacts of the interventions on different mobility variables. Heterogeneous variables and instruments were used to assess quality of life and, in particular, mobility, which made it difficult to compare the results of the studies. Approximately 50% of the identified studies had small sample sizes. [ABSTRACT FROM AUTHOR]

Aim: To develop a set of evidence‐informed strategies to assist older people to improve swallowing functions and prevent further damage from complications. Design: A two‐round Delphi survey. Methods: An initial set of dysphagia care strategies with 74 relevant items for older people was formed based on a literature review by seven researchers. An online survey was conducted by 21 panellists, and data of experts' opinions were collected and analysed by improved Delphi method. Results: The positive coefficients in the two rounds of expert consultation were 85.71% and 83.33%, respectively. Consensus was reached with 53 items included and was allocated into the following five sections: (1) screening, (2) assessment, (3) training, (4) interventions and (5) management. These strategies were named with the acronym of each section—"SATIA". The management strategy can be applied to guide the management of older people with dysphagia. [ABSTRACT FROM AUTHOR]

Introduction: Following 2016 legislation permitting limited access to cannabis for research and medicinal purposes, the number of randomized clinical trials (RCTs) investigating the effectiveness of medicinal cannabis (MC) on symptom burden relief in cancer contexts has increased in Australia. This study aimed to understand the perceptions, hopes and concerns of people with advanced cancer regarding the future availability and regulation of MC in Australia. Methods: This qualitative study draws on semistructured interviews conducted between February 2019 and October 2020 in Brisbane, Australia, as part of an MC RCT substudy. Interviews were undertaken on 48 patients with advanced cancer in palliative care eligible to participate in an MC trial (n = 26 participated in an RCT; n = 2 participated in a pilot study; n = 20 declined). Interviews included a discussion of patients' decision‐making regarding trial participation, concerns about MC and perceptions of future availability, including cost. Transcribed interviews were analysed inductively and abductively, informed by constructivist thematic analysis conventions. Results: Overall, participants supported making MC legally accessible as a prescription‐only medication. Fear of financial toxicity, however, compromised this pathway. Steep posttrial costs of accessing MC prompted several people to decline trial participation, and others to predict—if found effective—that many would either access MC through alternative pathways or reduce their prescribed dosage to enable affordable access. Conclusions: These findings suggest that—despite a relatively robust universal healthcare system—Australians are potentially vulnerable to and fearful of financial toxicity. Prevalent in the United States, financial toxicity occurs when disadvantaged cancer patients access necessary but expensive medications with lasting consequences: bankruptcy, ongoing anxiety and cancer worry. Interview transcripts indicate that financial fears—and the systems sustaining them—may pose a threat to RCT completion and to equitable access to legal MC. Such findings support calls for embedding qualitative substudies and community partnerships within RCTs, while also suggesting the importance of subsidisation to overcoming injustices. Patient or Public Contribution: A patient advisory committee informed RCT design. This qualitative substudy foregrounds patients' decision‐making, perceptions and experiences. [ABSTRACT FROM AUTHOR]

Aim: The aim of this study was to explore patients' experiences of preventive anticoagulation therapy in atrial fibrillation. Design: This was a descriptive qualitative study based on interviews. Methods: Individual interviews with 15 patients, 6 women and 9 men, treated with preventive oral anticoagulant due to atrial fibrillation, were conducted. The interviews were analysed with qualitative content analysis. Results: Based on the analysis, the theme Managing a necessary evil emerged. The theme comprised the three categories: Coping with anxiety and changes in daily life, Having confidence in care and Being a partner or only a receiver of treatment. Patients described it like being faced with a situation where a treatment perceived as vital was weighed against undesirable consequences and risks. Patients trusted caregivers and had confidence in care, but there was a risk of being a receiver of care instead of becoming a partner. [ABSTRACT FROM AUTHOR]

Background: Fluid treatment in sepsis is a challenge and clinical equipoise exists regarding intravenous (IV) volumes. We aimed to determine whether a 24‐h protocol restricting IV fluid was feasible in adult patients with sepsis without shock presenting to the emergency department (ED). Methods: The REFACED Sepsis trial is an investigator‐initiated, multicenter, randomized, open‐label, feasibility trial, assigning sepsis patients without shock to 24 h of restrictive, crystal IV fluid administration or standard care. In the IV fluid restriction group fluid boluses were only permitted if predefined criteria for hypoperfusion occurred. Standard care was at the discretion of the treating team. The primary outcome was total IV crystalloid fluid volumes at 24 h after randomization. Secondary outcomes included total fluid volumes, feasibility measures, and patient‐centered outcomes. Results: We included 123 patients (restrictive 61 patients and standard care 62 patients) in the primary analysis. A total of 32% (95% confidence interval [CI] 28%–37%) of eligible patients meeting all inclusion criteria and no exclusion criteria were included. At 24 h, the mean (±SD) IV crystalloid fluid volumes were 562 (±1076) ml versus 1370 (±1438) ml in the restrictive versus standard care group (mean difference –801 ml, 95% CI −1257 to −345 ml, p = 0.001). Protocol violations occurred in 21 (34%) patients in the fluid‐restrictive group. There were no differences between groups in adverse events, use of mechanical ventilation or vasopressors, acute kidney failure, length of stay, or mortality. Conclusions: A protocol restricting IV crystalloid fluids in ED patients with sepsis reduced 24‐h fluid volumes compared to standard care. A future trial powered toward patient‐centered outcomes appears feasible. [ABSTRACT FROM AUTHOR]

Background: Poor health outcomes amongst marginalized groups result in part from health inequities related to social and structural determinants of health. Marginalized people report higher incidences of comorbidities, chronic disease and adverse health behaviours than their nondisadvantaged peers. The objective of this review is to examine marginalized Australians' experiences of and access to community‐based primary health services in urban locations. Methods: A systematic search incorporating related MeSH terms and synonyms pertaining to marginalized Australian populations and their health‐seeking was conducted across seven databases. We included qualitative studies that reported experiences of health‐seeking within community‐based primary health care in metropolitan Australia. Participant populations experiencing marginalization due to social stigma and isolation, early‐life disadvantage, poor health and/or financial hardship were included. A meta‐ethnographic framework was used to synthesize themes across selected studies and researcher triangulation was employed to develop higher‐order themes. Results: Search results revealed 26 studies included for critical appraisal and synthesis. Seven higher‐order themes were developed describing experiences of health service engagement amongst marginalized groups: (1) Understanding the patient within the context of family and community, (2) Health and cultural beliefs influence health‐seeking, (3) Lack of information and poor cultural competence limit utilization of services, (4) Motivation for treatment influences health service engagement, (5) Accessing services, a spectrum of experience—from discrimination to validation, (6) Navigating a complex system in a complex society, (7) Preferences for health care and expectations for systemic change. Conclusion: Marginalized Australians experience health disadvantage across micro, meso and macro levels of health system navigation and commonalities in health‐seeking were identified across each of the distinct marginalized groups in our analysis. This review outlines important areas of consideration for health care provision and policy development essential to helping address health inequities for a diversity of marginalized populations. Patient or Public Contribution: Whilst patient voices were reported across all studies included within this review, no further patient or public contribution applies to this study. [ABSTRACT FROM AUTHOR]

Micronutrient powders (MNP) are an efficacious intervention in terms of reducing anaemia among young children, yet challenges remain regarding implementation at scale. Research that can guide effective implementation of nutrition interventions and facilitate integration into existing health care platforms is needed. This paper seeks to advance the implementation science knowledge base by presenting our multiphased strategy and findings for scaling‐up MNP in Rwanda. The multiphased implementation strategy, spanning a 5‐year period (2011–2016), included (a) a feasibility study involving formative research, (b) a 30‐day trial of improved practices (n = 60 households), (c) a 12‐month pilot that included an effectiveness study (n = 1,066 caregiver/child pairs), and (d) a staggered approach to national scale‐up. At the end of Phase 4, the programme had been implemented in 19 of Rwanda's 30 districts with the scale‐up in the final 11 districts completed in the following year. The caregivers of over 270,000 eligible children 6–23 months of age received a box of 30 MNP sachets in the final 3‐month assessment period, representing a coverage rate of 87%. Initial problems with the supply chain and distribution and ongoing challenges to monitoring and reporting have been the largest obstacles. Continued success will be dependent on adequate resources for capacity development, refresher training, and responsive monitoring. Rwanda is one of the first countries to successfully scale‐up home fortification subnationally with MNP. Lessons learned have implications for other countries. [ABSTRACT FROM AUTHOR]

Background: Non‐small cell lung cancer (NSCLC) is the leading cause of cancer‐related mortality worldwide. It is advisable to select the appropriate treatment based on characteristics of the cancer such as pathology, mutations, and programmed death‐ligand 1 (PD‐L1) levels. In this study, by remarking squamous NSCLC with low PD‐L1 expression without mutations, we investigated the efficacy and safety of regimens that included molecularly targeted drugs such as immune checkpoint inhibitors (ICIs) through a network meta‐analysis. Methods: Databases were searched systematically to identify appropriate articles, in which randomized trials with incurable squamous NSCLC were described. Suitable studies were manually checked by two reviewers. A random model network meta‐analysis was conducted, in which the primary outcome was the overall survival rate. Results: We identified 48 studies, which included 16 391 patients. When a platinum + third‐generation cytotoxic agent regimen (platinum regimen) was a reference, the platinum regimen + pembrolizumab (Pemb) yielded the best results in regard to the overall survival rate when compared with chemotherapy (hazard ratio [HR] = 0.57, 95% confidence interval [CI] = 0.36–0.90, p = 0.016) followed by the platinum regimen + nivolumab (Niv) + ipilimumab (Ipi) (HR = 0.61, 95% CI = 0.44–0.84, p = 0.003). However, the efficacy of ICI monotherapy was not statistically different from that of the platinum regimen. Conclusions: The combination therapies, which were the platinum regimen + Pemb and the platinum regimen + Niv + Ipi, rather than ICI monotherapy were effective first‐line agents for treating squamous NSCLC with low PD‐L1 levels. [ABSTRACT FROM AUTHOR]

Objective: Currently, several immune checkpoint inhibitors (ICIs) treatment for advanced non‐small‐cell lung cancer (NSCLC) have been investigated; their overall efficacy and safety remain unclear. Methods: We searched electronic databases such as PubMed, EMBASE, and the Cochrane library. The randomized controlled trials (RCTs) that compared ICIs with or without chemotherapy to chemotherapy in advanced NSCLC. We collected and compaired thier parameters, including overall survival (OS), progression‐free survival (PFS), objective response rate (ORR), and treatment‐related adverse events (TRAEs) of grade ≥3. Results: A total of 15 RCTs involving 8869 patients with NSCLC were included. Pembrolizumab plus platinum‐based chemotherapy had higher OS and PFS than platinum‐based chemotherapy (hazard ratio [HR] 0.55, 95% CI 0.46–0.67; HR 0.54, 95% CI 0.41–0.70, respectively). Pembrolizumab plus platinum‐based chemotherapy had higher ranked ORR than platinum‐based chemotherapy (odds ratio [OR] 2.92, 95% CI 1.99–4.22). In terms of OS, atezolizumab, pembrolizumab plus platinum‐based chemotherapy, and nivolumab plus ipilimumab ranked as the best treatments for patients with programmed death‐ligand 1 (PD‐L1) expression levels of ≥50%, 1–49%, and <1%, respectively. In terms of PFS, pembrolizumab plus platinum‐based chemotherapy ranked as the best treatment for patients with any PD‐L1 expression levels. However, ipilimumab plus platinum‐based chemotherapy, nivolumab plus platinum‐based chemotherapy, and atezolizumab plus platinum‐based chemotherapy have higher TRAEs of grade ≥3 than platinum‐based chemotherapy. Conclusions: Pembrolizumab plus platinum‐based chemotherapy prevailed in rank in OS, PFS, and ORR benefit. The TRAEs of pembrolizumab plus platinum‐based chemotherapy were more than ICI monotherapy and chemotherapy. [ABSTRACT FROM AUTHOR]

Ready‐to‐use therapeutic foods (RUTF) used to treat children with severe acute malnutrition (SAM) are costly, and the prescribed dosage has not been optimized. The MANGO trial, implemented by Action Contre la Faim in Burkina Faso, proved the non‐inferiority of a reduced RUTF dosage in community‐based treatment of uncomplicated SAM. We performed a cost‐minimization analysis to assess the economic impact of transitioning from the standard to the reduced RUTF dose. We used a decision‐analytic model to simulate a cohort of 399 children/arm, aged 6–59 months and receiving SAM treatment. We adopted a societal perspective: direct medical costs (drugs, materials and staff time), non‐medical costs (caregiver expenses) and indirect costs (productivity loss) in 2017 international US dollar were included. Data were collected through interviews with 35 caregivers and 20 informants selected through deliberate sampling and the review trial financial documents. The overall treatment cost for 399 children/arm was $36,550 with the standard and $30,411 with the reduced dose, leading to $6,140 (16.8%) in cost savings ($15.43 saved/child treated). The cost/consultation was $11.6 and $9.6 in the standard and reduced arms, respectively, with RUTF accounting for 56.2% and 47.0% of the total. The savings/child treated was $11.4 in a scenario simulating the Burkinabè routine SAM treatment outside clinical trial settings. The reduced RUTF dose tested in the MANGO trial resulted in significant cost savings for SAM treatment. These results are useful for decision makers to estimate potential economic gains from an optimized SAM treatment protocol in Burkina Faso and similar contexts. [ABSTRACT FROM AUTHOR]

Objective: This study examined the influence of physicians' recommendations and gender on the decision‐making process in a preference‐sensitive situation. Methods: N = 201 participants were put in a hypothetical scenario in which they suffered from a rupture of the anterior cruciate ligament (ACL). They received general information on two equally successful treatment options for this injury (surgery vs physiotherapy) and answered questions regarding their treatment preference, certainty and satisfaction regarding their decision and attitude towards the treatment options. Then, participants watched a video that differed regarding physician's recommendation (surgery vs physiotherapy) and physician's gender (female vs male voice and picture). Afterwards, they indicated again their treatment preference, certainty, satisfaction and attitude, as well as the physician's professional and social competence. Results: Participants changed their treatment preferences in the direction of the physician's recommendation (P <.001). Decision certainty (P <.001) and satisfaction (P <.001) increased more strongly if the physician's recommendation was congruent with the participant's prior attitude than if the recommendation was contrary to the participant's prior attitude. Finally, participants' attitudes towards the recommended treatment became more positive (surgery recommendation: P <.001; physiotherapy recommendation: P <.001). We found no influence of the physician's gender on participants' decisions, attitudes, or competence assessments. Conclusion: This research indicates that physicians should be careful with recommendations when aiming for shared decisions, as they might influence patients even if the patients have been made aware that they should take their personal preferences into account. This could be particularly problematic if the recommendation is not in line with the patient's preferences. [ABSTRACT FROM AUTHOR]

Background: Stem cell therapy is a novel treatment option for people living with osteoarthritis. Research investigating stem cell therapy for this debilitating condition has predominantly involved the pathogenesis of the cells and efficacy of the treatment. There is little understanding of patients' expectations and experiences of stem cell therapy treatment. Objective: To explore the expectations and experiences of people undergoing stem cell therapy for the treatment of knee osteoarthritis. Design: An exploratory, descriptive, qualitative study using semi‐structured interviews was conducted. Setting and participants: Participants were recruited into two groups: (a) Expectations Group (n = 15); the expectations of stem cell treatment were explored with participants that were yet to commence stem cell therapy. (b) Experiences Group (n = 15); the experiences of stem cell therapy were explored with participants 12 months after their initial stem cell treatment. Transcripts were analysed using thematic analysis to identify themes in both groups. Results: Themes for the Expectations Group were active involvement in the treatment; treatment will improve symptoms; and benefits of treatment outweigh the risks. Themes for the Experiences Group were symptoms of treatment; satisfaction with treatment; and anticipation of further improvement. Discussion and conclusions: The findings are the first qualitative study to represent patients' perspective on expectations and experiences of stem cell therapy for knee osteoarthritis. They provide insight into the potential areas for improvement within this field to aid patients' preparation and approach to the treatment, promoting patient‐centred care. [ABSTRACT FROM AUTHOR]

Objective: Clinical trial results have shown that, in glucocorticoid‐treated patients, treatment with denosumab 60 mg subcutaneously once every 6 months (Q6M) increased spine and hip bone mineral density (BMD) at month 12 significantly more than treatment with risedronate 5 mg orally once daily (QD). The present analysis was performed to compare efficacy and characterize safety through month 24. Methods: This phase III study enrolled men and women ≥18 years old who had received ≥7.5 mg daily prednisone or equivalent for <3 months (glucocorticoid‐initiating) or for ≥3 months (glucocorticoid‐continuing) before screening. All patients <50 years old had a history of osteoporotic fracture. Glucocorticoid‐continuing patients ≥50 years old had T scores of −2.0 or less (or −1.0 or less with fracture history). Patients were randomized (1:1) to receive denosumab 60 mg subcutaneously Q6M or risedronate 5 mg orally QD for 24 months, with daily calcium and vitamin D. Results: Of 795 patients, 590 (74.2%) completed the study (in the glucocorticoid‐initiating group, 109 of 145 patients treated with denosumab and 117 of 145 patients treated with risedronate; in the glucocorticoid‐continuing group, 186 of 253 patients treated with denosumab and 178 of 252 patients treated with risedronate). Denosumab was superior to risedronate in increasing lumbar spine and total hip BMD at all time points assessed, among glucocorticoid‐initiating patients (24‐month lumbar spine: BMD increase of 6.2% versus 1.7%, respectively [P < 0.001]; 24‐month total hip: BMD increase of 3.1% versus 0.0% [P < 0.001]) and among glucocorticoid‐continuing patients (24‐month lumbar spine: BMD increase of 6.4% versus 3.2% [P < 0.001]; 24‐month total hip: BMD increase of 2.9% versus 0.5% [P < 0.001]). Adverse events, serious adverse events (including infections), and fractures were similar between treatment groups. Conclusion: Denosumab was superior to risedronate in terms of increases in spine and hip BMD through month 24, and the safety profile was similar between treatment groups. Denosumab may offer a new osteoporosis treatment option for glucocorticoid‐treated patients. [ABSTRACT FROM AUTHOR]

Objective: To evaluate radiographic progression in the sacroiliac (SI) joints and to identify its predictors during long‐term treatment (up to 6 years) with the tumor necrosis factor (TNF) inhibitor etanercept in patients with early axial spondyloarthritis (SpA). Methods: Patients with early axial SpA who were treated with etanercept for up to 6 years in the Etanercept versus Sulfasalazine in Early Axial Spondyloarthritis (ESTHER) trial were selected based on the availability of radiographs of the SI joints. Two readers who were blinded with regard to clinical data scored the radiographs according to the modified New York criteria (range 0–4 per SI joint). A sacroiliitis sum score (total range 0–8) was calculated as the mean of the scores of the 2 readers. Active and chronic inflammatory changes in the SI joints on magnetic resonance imaging (MRI) performed at baseline, year 2, and year 4 were assessed according to the Berlin MRI scoring system. Results: Of the 76 patients originally included in the study, 42 had radiographs of the SI joints available at baseline and at least 1 follow‐up time point (year 2, 4, or 6). The mean ± SD change in the sacroiliitis sum score was 0.13 ± 0.73, −0.27 ± 0.76, and −0.09 ± 0.68, in the time intervals baseline to year 2, year 2 to year 4, and year 4 to year 6, respectively. In the longitudinal mixed model analysis, elevated C‐reactive protein level (β = 0.58 [95% confidence interval 0.24, 0.91]) and MRI SI joint osteitis score (β = 0.06 [95% confidence interval 0.03, 0.10]) were independently associated with progression of the sacroiliitis sum score. Conclusion: Our findings indicate that long‐term anti‐TNF therapy decelerates the progression of structural damage in the SI joints. Elevated CRP level and presence of osteitis on MRI were independently associated with radiographic sacroiliitis progression. [ABSTRACT FROM AUTHOR]

Background: This study aimed to determine the failure rate of a combination of the PERC and the YEARS rules for the diagnosis of pulmonary embolism (PE) in the emergency department (ED). Methods: We performed a retrospective analysis of two European cohorts of emergency patients with low gestalt clinical probability of PE (PROPER and PERCEPIC). All patients we included were managed using a conventional strategy (D‐dimer test, followed, if positive, by computed tomographic pulmonary angiogram (CTPA). We tested a diagnostic strategy that combined PERC and YEARS to rule out PE. The primary endpoint was a thromboembolic event diagnosed in the ED or at 3‐months follow‐up. Secondary endpoints included a thromboembolic event at baseline in the ED and a CTPA in the ED. Ninety‐five percent confidence intervals (CIs) of proportions were calculated with the use of Wilson's continuity correction. Results: We analyzed 1,951 patients (mean ± SD age = 47 ± 18 years, 56% women) with an overall proportion of patients with PE of 3.5%. Both PERC and YEARS strategies were associated with 11 missed PE in the ED: failure rate 0.57 (95% CI = 0.32–1.02). At 3‐month follow‐up, the overall failure rate was 0.83% (95% CI = 0.51–1.35). Among the 503 patients who underwent a CTPA (26%), the use of the PERC–YEARS combination would have ruled out PE without CTPA in 249 patients (50% [95%CI = 45%–54%], absolute reduction 13% (95% CI = 11%–14%]). Conclusion: The combination of PERC then YEARS was associated with a low risk of PE diagnostic failure and would have resulted in a relative reduction of almost half of CTPA. [ABSTRACT FROM AUTHOR]

Objectives: Pediatric asthma is a leading cause of emergency department (ED) utilization and hospitalization. Earlier identification of need for hospital‐level care could triage patients more efficiently to high‐ or low‐resource ED tracks. Existing tools to predict disposition for pediatric asthma use only clinical data, perform best several hours into the ED stay, and are static or score‐based. Machine learning offers a population‐specific, dynamic option that allows real‐time integration of available nonclinical data at triage. Our objective was to compare the performance of four common machine learning approaches, incorporating clinical data available at the time of triage with information about weather, neighborhood characteristics, and community viral load for early prediction of the need for hospital‐level care in pediatric asthma. Methods: Retrospective analysis of patients ages 2 to 18 years seen at two urban pediatric EDs with asthma exacerbation over 4 years. Asthma exacerbation was defined as receiving both albuterol and systemic corticosteroids. We included patient features, measures of illness severity available in triage, weather features, and Centers for Disease Control and Prevention influenza patterns. We tested four models: decision trees, LASSO logistic regression, random forests, and gradient boosting machines. For each model, 80% of the data set was used for training and 20% was used to validate the models. The area under the receiver operating characteristic (AUC) curve was calculated for each model. Results: There were 29,392 patients included in the analyses: mean (±SD) age of 7.0 (±4.2) years, 42% female, 77% non‐Hispanic black, and 76% public insurance. The AUCs for each model were: decision tree 0.72 (95% confidence interval [CI] = 0.66–0.77), logistic regression 0.83 (95% CI = 0.82–0.83), random forests 0.82 (95% CI = 0.81–0.83), and gradient boosting machines 0.84 (95% CI = 0.83–0.85). In the lowest decile of risk, only 3% of patients required hospitalization; in the highest decile this rate was 100%. After patient vital signs and acuity, age and weight, followed by socioeconomic status (SES) and weather‐related features, were the most important for predicting hospitalization. Conclusions: Three of the four machine learning models performed well with decision trees preforming the worst. The gradient boosting machines model demonstrated a slight advantage over other approaches at predicting need for hospital‐level care at the time of triage in pediatric patients presenting with asthma exacerbation. The addition of weight, SES, and weather data improved the performance of this model. [ABSTRACT FROM AUTHOR]

Abstract: Understanding implementation of interventions is critical to illuminate if, how, and why the interventions achieve impact. Alive & Thrive integrated a nutrition intervention into an existing maternal, neonatal, and child health (MNCH) programme in Bangladesh, documenting improvements in women's micronutrient supplement intake and dietary diversity. Here, we examined how well the nutrition intervention was implemented and which elements of implementation explained intervention impact. Survey data were collected in 2015 and 2016 from frontline health workers (FLW) and households in areas randomized to nutrition‐focused MNCH (intensified interpersonal counselling, community mobilization, distribution of free micronutrient supplements, and weight‐gain monitoring) or standard MNCH (antenatal care with standard nutrition counselling). Seven intervention elements were measured: time commitment, training quality, knowledge, coverage, counselling quality, supervision, and incentives. Multiple regression was used to derive difference‐in‐differences (DID) estimates. Using village‐level endline data, path analysis was used to determine which elements most explained intervention impacts. FLWs in both areas were highly committed and well supervised. Coverage was high (>90%) for counselling, supplement provision, and weight‐gain monitoring. Improvements were significantly greater for nutrition‐focused MNCH, versus standard MNCH, for training quality (DID: 2.42 points of 10), knowledge (DID: 1.20 points), delivery coverage (DID: 4.16 points), and counselling quality (DID: 1.60 points). Impact was substantially explained by coverage and delivery quality. In conclusion, integration nutrition intervention into the MNCH programme was feasible and well‐implemented. Although differences in coverage and counselling quality most explained impacts, all intervention elements—particularly FLW training and performance—were likely important to achieving impact. [ABSTRACT FROM AUTHOR]

Abstract: Small‐quantity lipid‐based nutrient supplements (SQ‐LNS) have been studied in efficacy and effectiveness trials, but little is known about how parents perceive the products and their effects. In a randomised trial in Ghana, efficacy of SQ‐LNS provided to women during pregnancy and the first 6 months postpartum and to their children from 6 to 18 months of age was assessed by comparison with iron‐folic acid (IFA) capsules and multiple micronutrient (MMN) capsules provided to women. In a follow‐up study conducted when the index children from the original trial were between 4 and 6 years of age, we used survey‐based methods to assess retrospective and current parental perceptions of nutrient supplements generally and of SQ‐LNS and their effects compared with perceptions IFA and MMN capsules. Most parents perceived that the assigned supplements (SQ‐LNS, IFA, or MMN) positively impacted the mother during pregnancy (approximately 89% of both mothers and fathers) and during lactation (84% of mothers and 86% of fathers). Almost all (≥90%) of mothers and fathers perceived that the assigned supplement positively impacted the index child and expected continued positive impacts on the child's health and human capital into the future. A smaller percentage of parents perceived negative impacts of the supplements (7%–17% of mothers and 4%–12% of fathers). Perceptions of positive impacts and of negative impacts did not differ by intervention group. The results suggest that similar populations would likely be receptive to programs to deliver SQ‐LNS or micronutrient capsules. [ABSTRACT FROM AUTHOR]

Abstract: Background: Low back pain (LBP) is an extremely frequent reason for patients to present to an emergency department (ED). Despite evidence against the utility of imaging, simple and advanced imaging (i.e., computed tomography [CT], magnetic resonance imaging) for patients with LBP has become increasingly frequent in the ED. The objective of this review was to identify and examine the effectiveness of interventions aimed at reducing image ordering in the ED for LBP patients. Methods: A protocol was developed a priori, following the PRISMA guidelines, and registered with PROSPERO. Six bibliographic databases (including MEDLINE, EMBASE, EBM Reviews, SCOPUS, CINAHL, and Dissertation Abstracts) and the gray literature were searched. Comparative studies assessing interventions that targeted image ordering in the ED for adult patients with LBP were eligible for inclusion. Two reviewers independently screened study eligibility and completed data extraction. Study quality was completed independently by two reviewers using the before–after quality assessment checklist, with a third‐party mediator resolving any differences. Due to a limited number of studies and significant heterogeneity, only a descriptive analysis was performed. Results: The search yielded 603 unique citations of which a total of five before–after studies were included. Quality assessment identified potential biases relating to comparability between the pre‐ and postintervention groups, reliable assessment of outcomes, and an overall lack of information on the intervention (i.e., time point, description, intervention data collection). The type of interventions utilized included clinical decision support tools, clinical practice guidelines, a knowledge translation initiative, and multidisciplinary protocols. Overall, four studies reported a decrease in the relative percentage change in imaging in a specific image modality (22.7%–47.4%) following implementation of the interventions; however, one study reported a 35% increase in patient referrals to radiography, while another study reported a subsequent 15.4% increase in referrals to CT and myelography after implementing an intervention which reduced referrals for simple radiography. Discussion: While imaging of LBP has been identified as a key area of imaging overuse (e.g., Choosing Wisely recommendation), evidence on interventions to reduce image ordering for ED patients with LBP is sparse. There is some evidence to suggest that interventions can reduce the use of simple imaging in LBP in the ED; however, a shift in imaging modality has also been demonstrated. Additional studies employing higher‐quality methods and measuring intervention fidelity are strongly recommended to further explore the potential of ED‐based interventions to reduce image ordering for this patient population. [ABSTRACT FROM AUTHOR]

Objectives: Rate control is an important component of the management of patients with atrial fibrillation (AF). Previous studies of emergency department (ED) rate control have been limited by relatively small sample sizes. We examined the use of beta-blockers (BBs) versus nondihydropyridine calcium channel blockers (CCBs) in ED patients from 24 sites and the associated hospital admission rates. Methods: In this preplanned substudy, we examined chart data on AF patients who visited one of 24 hospital EDs in Ontario, Canada, between April 2008 and March 2009. We describe the proportion of patients who received either a BB or a CCB, had a heart rate < 110 beats/min 2 hours later, and had any complications. We used hierarchical logistic regression modeling to determine the predictors of BB versus CCB use and to assess the between-hospital variation in use of BBs versus CCBs. Solely in patients who had no rhythm control attempts, we examined the difference in the probability of hospital admission after propensity score matching patients by medication class. Results: Of the 1,639 patients who received either a BB (n = 429) or a CCB (n = 1,210), 70.9% of the patients who received a BB had successful rate control versus 66.1% for a CCB. Complications were rare (2.4%), and the large majority were hypotension (2.0%). In adjusted analyses, predictors of receiving a BB (compared to a CCB) included already being on a BB, being sent in from a doctor’s office, or being seen at a teaching hospital. In contrast, patients with evidence of heart failure, prior use of a CCB, a higher presenting heart rate, or a successful pharmacologic cardioversion (vs. no attempt) or who were seen at the highest AF volume EDs were significantly less likely to receive a BB, compared to a CCB. Systematic between-hospital differences accounted for 8% of the variation in BB versus CCB use. Hospital characteristics accounted for the large majority of that variation: after accounting for patient characteristics the between-hospital variation decreased by a relative 2.8%. By further adjusting for hospital characteristics, it decreased by a relative 74.7%. Among propensity score–matched patients with no rhythm control attempts, more CCB patients were admitted (51.6%) compared to BB patients (40.0%; difference of 11.6%; 95% confidence interval = 7.9%–16.2%). Conclusions: In this study of 24 EDs, CCBs were used more frequently for rate control than BBs, and complications were rare and easily managed using both agents. Variation between hospitals in BB versus CCB use was predominantly due to hospital characteristics such as teaching status and AF volumes, rather than different case mix. Among patients who did not receive attempts at rhythm control, use of a BB for rate control was associated with a lower rate of hospitalization. [ABSTRACT FROM AUTHOR]

Objective: Gastroparesis is a debilitating condition that causes nausea, vomiting, and abdominal pain. Management includes analgesics and antiemetics, but symptoms are often refractory. Haloperidol has been utilized in the palliative care setting for similar symptoms. The study objective was to determine whether haloperidol as an adjunct to conventional therapy would improve symptoms in gastroparesis patients presenting to the emergency department (ED). Study Design and Methods: This was a randomized, double-blind, placebo-controlled trial of adult ED patients with acute exacerbation of previously diagnosed gastroparesis. The treatment group received 5 mg of haloperidol plus conventional therapy (determined by the treating physician). The control group received a placebo plus conventional therapy. The severity of each subject’s abdominal pain and nausea were assessed before intervention and every 15 minutes thereafter for 1 hour using a 10-point scale for pain and a 5-point scale for nausea. Primary outcomes were decreased pain and nausea 1 hour after treatment. Results: Of the 33 study patients, 15 were randomized to receive haloperidol. Before treatment, the mean intensity of pain was 8.5 in the haloperidol group and 8.28 in the placebo group; mean pretreatment nausea scores were 4.53 and 4.11, respectively. One hour after therapy, the mean pain and nausea scores in the haloperidol group were 3.13 and 1.83 compared to 7.17 and 3.39 in the placebo group. The reduction in mean pain intensity therapy was 5.37 in the haloperidol group (p ≤ 0.001) compared to 1.11 in the placebo group (p = 0.11). The reduction in mean nausea score was 2.70 in the haloperidol group (p ≤ 0.001) and 0.72 in the placebo group (p = 0.05). Therefore, the reductions in symptom scores were statistically significant in the haloperidol group but not in the placebo group. No adverse events were reported. Conclusions: Haloperidol as an adjunctive therapy is superior to placebo for acute gastroparesis symptoms. [ABSTRACT FROM AUTHOR]

Objectives Higher resource utilization in the management of pediatric patients with undifferentiated vomiting and/or diarrhea does not correlate consistently with improved outcomes or quality of care. Performance feedback has been shown to change physician practice behavior and may be a mechanism to minimize practice variation. We aimed to evaluate the effects of e-mail-only, provider-level performance feedback on the ordering and admission practice variation of pediatric emergency physicians for patients presenting with undifferentiated vomiting and/or diarrhea. Methods We conducted a prospective, quality improvement intervention and collected data over 3 consecutive fiscal years. The setting was a single, tertiary care pediatric emergency department. We collected admission and ordering practices data on 19 physicians during baseline, intervention, and postintervention periods. We provided physicians with quarterly e-mail-based performance reports during the intervention phase. We measured admission rate and created four categories for ordering practices: no orders, laboratory orders, pharmacy orders, and radiology orders. Results There was wide (two- to threefold) practice variation among physicians. Admission rates ranged from 15% to 30%, laboratory orders from 19% to 43%, pharmacy orders from 29% to 57%, and radiology orders from 11% to 30%. There was no statistically significant difference in the proportion of patients admitted or with radiology or pharmacy orders placed between preintervention, intervention, or postintervention periods (p = 0.58, p = 0.19, and p = 0.75, respectively). There was a significant but very small decrease in laboratory orders between the preintervention and postintervention periods. Conclusions Performance feedback provided only via e-mail to pediatric emergency physicians on a quarterly basis does not seem to significantly impact management practices for patients with undifferentiated vomiting and/or diarrhea. [ABSTRACT FROM AUTHOR]

Objective To compare mycophenolate mofetil (MMF) with placebo for the treatment of systemic sclerosis (SSc)-related interstitial lung disease (ILD). Methods We included participants enrolled in the placebo arm of Scleroderma Lung Study (SLS) I and the MMF arm of SLS II. SLS I randomized participants to receive either oral cyclophosphamide (CYC) or placebo for 1 year, while SLS II randomized participants to receive either MMF for 2 years or oral CYC for 1 year followed by 1 year of placebo. Eligibility criteria for SLS I and SLS II were nearly identical. The primary outcome was % predicted forced vital capacity (FVC), and key secondary outcomes included % predicted diffusing capacity for carbon monoxide (DL co), the modified Rodnan skin thickness score (MRSS), and dyspnea. Joint models were created to evaluate the treatment effect on the course of these outcomes over 2 years. Results At baseline, the MMF-treated group in SLS II (n = 69) and the placebo-treated group in SLS I (n = 79) had similar percentages of men and women and similar disease duration, SSc subtype, extent of skin disease, and % predicted FVC. MMF-treated patients in SLS II were slightly older (mean ± SD age 52.6 ± 9.7 years versus 48.1 ± 12.4 years; P = 0.0152) and had higher % predicted DL co (mean ± SD 54.0 ± 11.1 versus 46.2 ± 13.3; P = 0.0002) than placebo-treated patients in SLS I. After adjustment for baseline disease severity, treatment with MMF in comparison with placebo was associated with improved % predicted FVC ( P < 0.0001), % predicted DL co ( P < 0.0001), MRSS ( P < 0.0001), and dyspnea ( P = 0.0112) over 2 years. Conclusion Although there are inherent limitations in comparing participants from different trials, treatment with MMF was associated with improvements in physiologic outcomes and dyspnea compared with placebo, even after accounting for baseline disease severity. These results further substantiate the use of MMF for the treatment of SSc-related ILD. [ABSTRACT FROM AUTHOR]

Background Variations in syncope management exist. Our objective was to identify the reasons for consultations and hospitalizations and outcomes among emergency department ( ED) syncope patients. Methods We conducted a prospective cohort study to enroll adult syncope patients at five EDs. We collected baseline characteristics, reasons for consultation and hospitalization, and hospital length of stay. Adjudicated 30-day serious adverse events ( SAEs) including death, myocardial infarction, arrhythmia, structural heart disease, pulmonary embolism, significant hemorrhage, and procedural intervention. We used descriptive analysis. Results From 4,064 enrolled patients (mean ± SD age = 53.1 ± 23.2 years; 55.9% female), 3,255 (80.1%) were discharged directly by the ED physician. Of those with no SAEs identified in the ED ( n = 600), 42.8% of referrals and 46.5% of hospitalizations were for suspected arrhythmias, and 71.2% of patients hospitalized for arrhythmias had no cause identified. SAEs among groups were 9.7% in total, 2.5% discharged by ED physician, 3.4% discharged by consultant, 21.7% as inpatient, and 4.8% following discharge from hospital. The median hospital length of stay for suspected arrhythmias was 5 days (interquartile range = 3 to 8 days). Conclusion Cardiac syncope, particularly suspected arrhythmia, was the major reason for ED referrals and hospitalization. The majority of patients hospitalized for cardiac monitoring had no identified cause. An important number of patients suffered SAEs, particularly arrhythmias, outside the hospital. Development of a risk-stratification tool and out-of-hospital cardiac monitoring strategy should improve patient safety and save substantial resources. [ABSTRACT FROM AUTHOR]

Objectives Outpatient treatment of acute venous thromboembolism (VTE) requires the selection of patients with a low risk of bleeding during the first few weeks of anticoagulation. The accuracy of four systems, originally derived for predicting bleeding in VTE treated with vitamin K antagonists (VKAs), was assessed in VTE patients treated with rivaroxaban. Methods All patients treated with rivaroxaban in the multinational EINSTEIN deep vein thrombosis (DVT) and pulmonary embolism (PE) trials were included. Major bleeding was defined as ≥2 g/dL drop in hemoglobin or ≥2-unit blood transfusion, bleeding in critical area, or bleeding contributing to death. The authors examined the incidence of major bleeding in patients with low-risk assignment by the systems of Ruiz-Gimenez et al. (score = 0 to 1), Beyth et al. (score = 0), Kuijer et al. (score = 0), and Landefeld and Goldman. (score = 0). For clinical relevance, the definition of low risk for all scores except Kuijer includes all patients < 65 years with no prior bleeding history and no comorbid conditions (current cancer, renal insufficiency, diabetes mellitus, anemia, prior stroke, or myocardial infarction). Results A total of 4,130 patients (1,731 with DVT only, 2,399 with PE with or without DVT) were treated with rivaroxaban for a mean (±SD) duration of 207.6 (±95.9) days. Major bleeding occurred in 1.0% (40 of 4,130; 95% confidence interval [CI] = 0.7% to 1.3%) overall. Rates of major bleeding for low-risk patients during the entire treatment period were similar: Ruiz-Gimenez et al., 12 of 2,622 (0.5%; 95% CI = 0.2% to 0.8%); Beyth et al., nine of 2,249 (0.4%; 95% CI = 0.2% to 0.8%); Kuijer et al., four of 1,186 (0.3%; 95% CI = 0.1% to 0.9%); and Landefeld and Goldman, 11 of 2,407 (0.5%; 95% CI = 0.2% to 0.8%). At 30 days, major bleed rates for low-risk patients were as follows: Ruiz-Gimenez et al., five of 2,622 (0.2%; 95% CI = 0.1% to 0.4%); Beyth et al., five of 2,249 (0.2%; 95% CI = 0.1% to 0.5%); Kuijer et al., three of 1,186 (0.3%; 95% CI = 0.1% to 0.7%); and Landefeld and Goldman, seven of 2,407 (0.3%; 95% CI = 0.1% to 0.6%). No low-risk patient had a fatal bleed. Conclusions Four scoring systems that use criteria obtained in routine clinical practice, derived to predict low bleeding risk with VKA treatment for VTE, identified patients with less than a 1% risk of major bleeding during full-course treatment with rivaroxaban. [ABSTRACT FROM AUTHOR]

Copyright of Academic Emergency Medicine is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Objective To evaluate the presence of spinal inflammation with and without sacroiliac (SI) joint inflammation on magnetic resonance imaging (MRI) in patients with active nonradiographic axial spondyloarthritis (SpA), and to compare the disease characteristics of these subgroups. Methods ABILITY-1 is a multicenter, randomized, controlled trial of adalimumab versus placebo in patients with nonradiographic axial SpA classified using the Assessment of SpondyloArthritis international Society axial SpA criteria. Baseline MRIs were centrally scored independently by 2 readers using the Spondyloarthritis Research Consortium of Canada (SPARCC) method for the SI joints and the SPARCC 6-discovertebral unit method for the spine. Positive evidence of inflammation on MRI was defined as a SPARCC score of ≥2 for either the SI joints or the spine. Results Among patients with baseline SPARCC scores, 40% had an SI joint score of ≥2 and 52% had a spine score of ≥2. Forty-nine percent of patients with baseline SI joint scores of <2, and 58% of those with baseline SI joint scores of ≥2, had a spine score of ≥2. Comparison of baseline disease characteristics by baseline SI joint and spine scores showed that a greater proportion of patients in the subgroup with a baseline SPARCC score of ≥2 for both SI joints and spine were male, and patients with spine and SI joint scores of <2 were younger and had shorter symptom duration. SPARCC spine scores correlated with baseline symptom duration, and SI joint scores correlated negatively with the baseline Bath Ankylosing Spondylitis Disease Activity Index, but neither correlated with the baseline Ankylosing Spondylitis Disease Activity Score, total back pain, the patient's global assessment of disease activity, the Bath Ankylosing Spondylitis Functional Index, morning stiffness, nocturnal pain, or C-reactive protein level. Conclusion Assessment by experienced readers showed that spinal inflammation on MRI might be observed in half of patients with nonradiographic axial SpA without SI joint inflammation. [ABSTRACT FROM AUTHOR]

Copyright of Academic Emergency Medicine is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Copyright of Academic Emergency Medicine is the property of Wiley-Blackwell and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

ACADEMIC EMERGENCY MEDICINE 2012; 19:265-273 © 2012 by the Society for Academic Emergency Medicine Abstract Objectives: This study was performed to evaluate the burn wound-healing efficacy of crocodile oil from Crocodylus siamensis by employing deep second-degree burns in a Wistar rat model. Methods: Twenty-four rats were assigned equally into four groups using a random-number table, and two burns were created on the dorsum of each animal except for the sham group. The three treatment groups received with saline solution (12 burns, served as negative control), silver sulfadiazine (12 burns, served as positive control), or crocodile oil (12 burns). Silver sulfadiazine cream was used as standard care, and the treatments were repeated twice daily for 28 days. After day 28 the animals were euthanized and the wounds were removed for quantitative real-time polymerase chain reaction, histologic, and immunohistochemical study. Results: Crocodile oil accelerated the wound-healing process as indicated by a significant decrease in wound closure time in comparison to the burn control and silver sulfadiazine treatment groups. Histologic results showed well-organized and distributed skin structure and collagen deposition in the animals treated with crocodile oil. Transforming growth factor-β1 (TGF-β1), a key cytokine promoting scarring, was also observed to play a role in the burn wound healing. Immunohistochemical staining results showed the negative expression of TGF-β1 and Smad3 in the 28-days-postburn skin of crocodile oil group versus positive in the epidermis of burn controls. Compared to the burn control group, expressions of TGF-β1 and Smad3 mRNA decreased significantly (p < 0.01) in the 28-days-postburn skin of the crocodile oil group. Conclusions: Our results showed that crocodile oil could enhance cutaneous burn wound healing and reduce scar formation in rats, which might be related to TGF-β1/Smad3 signaling. [ABSTRACT FROM AUTHOR]