Blockchain Papers

Amila S. Ratnayake, Dinesh Bagaria, April B. Llaneta, Ratrawee Pattanarattanamolee · 18 authors

Abstract Background Well-designed and functioning emergency medical service (EMS) can provide equitable access to emergency care to improve health issues, especially in low- and middle-income countries where the majority of deaths are due to conditions that could be treated with emergency care. To address this gap, this study explored the contextually appropriate development process in addition to the system architecture, which is lacking in Global South EMS research. Method This study was a thematic analysis of the development of EMS systems in six Asian countries. Experts in emergency care were selected through convenience sampling. Each country described and evaluated its EMS system using a standardized form with 102 EMS items that cover the emergency care system in terms of leadership, governance, financing, community-based activities, prehospital care, and quality assessment. From the descriptions, various themes were extracted focusing on the developmental perspective of EMS in Asia. Result The study identified the domain of the developmental focus, best practices, and future strategies for EMS in the Asian region. The identified areas for developmental focus are governance, multidisciplinary collaboration, communication/coordination, community participation, decentralization, equitable access, supply-demand balance, and quality assurance activities. Conclusion Countries under investigation achieved progress in planning, implementing, and sustaining EMS through varied strategies in the mentioned focal areas that can be emulated by other countries in this region. Further, their development levels varied according to the extent to which each country realized the development principles identified in this study.

Christopher R. Carpenter, Lucas Oliveira J. e Silva, Suneel Upadhye, Joshua Broder · 5 authors

Emergency medicine is often a specialty defined by diagnostic uncertainty when worried patients present with constellations of symptoms seeking explanation and relief. Abdominal pain is a common chief complaint among adult emergency department (ED) patients, with recurrent symptoms in the subsequent days, weeks, months, and even years, sometimes prompting repeat evaluations.1 The differential diagnosis is broad and diverse, including multiple organs and systems and extraabdominal causes. Ideally, clinical practice guidelines (CPGs) synthesize the entirety of evidence for questions relevant to an explicitly defined patient population and outcomes, but until now no CPG existed for the scenario of recurrent abdominal pain. Consequently, significant practice variation exists in the diagnostic and therapeutic approach to this clinical condition.2 The Society for Academic Emergency Medicine (SAEM) second "Guidelines for Reasonable and Appropriate Care in the Emergency Department 2 (GRACE-2)" article provides that CPG with adherence to Grading of Recommendations, Assessment, Development and Evaluations (GRADE) methodology including incorporation of patient priorities and external stakeholders.3 Through adherence to the GRADE methodology we aimed to create rigorous and trustworthy guidelines. The GRACE-2 writing team deliberated to select topics and questions and to explicitly define a clinically meaningful population, ultimately settling on definitions of recurrence within 30 days and adults with "low-risk" abdominal pain. Identifying no well-accepted or validated definition of "low risk" (as opposed to a risk model like the HEART score for chest pain4), the GRACE-2 writing team devised a definition of "low risk" that resonated with our clinical intuition and excluded populations that emergency physicians would routinely identify as moderate or high risk. Subsequently, the GRACE-2 writing team worked with medical librarians to focus searches based on the patient-intervention-control-outcome-time (PICOT) template5 and completed systematic reviews for each question before developing the recommendations.6, 7 The PICOT-oriented literature search revealed no studies that aligned with our definition of low risk and few that defined recurrence within our predefined time frame. However, that does not mean that our search rendered zero published evidence around which GRACE-2 could contemplate actionable recommendations via the GRADE Evidence to Decision (EtD) framework.8, 9 We had to make a decision about how to classify and incorporate the published research that we did identify. GRADE provides a framework for evidence synthesis and development of clinical guidelines and recommends inclusion of both direct and indirect evidence into CPGs, while providing guidance around the distinction between the two.8-12 Therefore, we decided to classify evidence as "direct" if each element of the PICOT question matched the study's inclusion criteria and outcomes assessed. "Indirect" evidence was defined by deviation from any component of the PICOT question (Table 1). These definitions are necessary for guideline developers who need to evaluate the domain of indirectness when rating the certainty of evidence.10, 12 Since the overall value of CPGs rests upon the rigor and transparency of the evidentiary search, quality assessment, and synthesis in conjunction with an explicit and representative assessment of anticipated benefits or potential harms of the subsequent recommendations, weighing the pros and cons of including indirect evidence is merited while considering if and how to incorporate the GRACE-2 recommendations into ED practice. Not emergency department Not adult Not recurrent Not undifferentiated abdominal pain Not low risk Initial CT identified explanatory pathology like kidney stone Repeat CT >12 months after initial CT GRADE recognizes indirectness as a key domain in the assessment of certainty of evidence.10, 12 Whenever systematic review authors or guideline developers identify important indirectness issues from a body of evidence that deviates from the original PICOT question, the certainty of evidence must be downgraded by one or two levels.10, 12 Despite such guidance from GRADE, conceptualization of what type of indirect evidence could be synthesized and used by CPGs remains debatable, especially when there is insufficient direct evidence.13 Also, a second layer of complexity is added when guideline developers need to evaluate the directness of research evidence for all criteria of the GRADE EtD framework including values, resources, cost-effectiveness, equity, acceptability, and feasibility. This cognitive framework can quickly diffuse into uncertainties. Nonetheless, indirect evidence is not fundamentally or inevitably flawed. For example, a study might be rated as indirect because the age range of enrolled subjects does not perfectly match the intended population or because the time frame of follow-up slightly exceeds the desired target. Such evidence may provide a very reasonable estimate of the range of expected outcomes in the intended population. In addition, many randomized controlled trials employ so many exclusion criteria and carefully controlled experimental conditions that the results may not predict outcomes in a broader ED population. GRADE attempts to distill value from the broad range of available evidence, rather than taking a nihilistic attitude that rejects evidence on the basis of any imperfection. Nihilism suggests "we know nothing" and have no basis for any decision—but emergency medicine requires that physicians make the best decision possible based on the available, if imperfect, evidence in a more pragmatic approach. GRADE recommends that if a large body of indirect evidence that can be convincingly linked to the PICOT support the management strategy, recommendations should be made.14 Specifically, GRADE states that "clinicians will rarely explore the evidence as thoroughly as a guideline panel, nor devote as much thought to the trade-offs, or the possible underlying values and preferences in the population. We therefore encourage panels to deal with their discomfort and to make recommendations even when confidence in effect estimate is low and/or desirable and undesirable consequences are closely balanced."15 The ideal strategy to dealing with absent direct evidence for a certain question during CPG development is not fully established among guideline developers, and each panel along with their methodologists need to individualize such decisions according to resource availability (e.g., methodological expertise, funding) and feasibility. Murad et al.,13 for example, suggest five strategies for supplementing systematic review findings when evidence on benefits or harms is found to be insufficient, including: (1) reconsider eligible study designs, (2) summarize indirect evidence, (3) summarize contextual and implementation evidence, (4) consider modeling, and (5) incorporate unpublished health system data in the evidence synthesis. In GRACE-2, summary of indirect evidence was chosen as the main approach and different "bodies of indirect evidence" were systematically synthesized.6, 7 As three out of four questions in GRACE-2 were related to diagnostic tests, we also faced the reality that direct evidence evaluating the impact of different testing strategies on patient-important outcomes (i.e., diagnostic randomized trials) seldom exists, which ultimately leads to the use of different types of indirect evidence such as diagnostic accuracy.16-18 Even within the adaptive framework of GRADE, indirect evidence may leave the PICOT question unanswered, and subsequent recommendations are often necessarily weak or nonexistent. Strong and definitive recommendations necessitate multiple studies evaluating the identical patient population and diagnostic approach quantifying the same outcomes in similar time frames with minimal concerns about health inequities, resource consumption, imprecision, or feasibility. Indirect evidence alone is unlikely to justify strong recommendations, but does provide substantive proof of the scope of the problem relative to the paucity of evidence. If the indirect evidence was excluded, CPG stakeholders would not be cognizant that this research was identified and reviewed in developing the recommendations. Clinicians, educators, and researchers would remain unaware of how little empiric evidence exists around which to shape decision making or how future investigators could more directly address the knowledge void. GRACE-2 is not alone in identifying a painfully surprising gap between what emergency medicine thinks is common knowledge and high-quality research to justify those beliefs. One reflection of this is that the majority of American College of Emergency Physician Clinical Policy recommendations are not level A.19 Ultimately, concerns about the directness of evidence for CPGs represent an existential crisis for emergency medicine. As society's safety net for potentially life-threatening medical, surgical, or psychiatric illness, emergency medicine's breadth of knowledge must remain broad and open-ended as clinical science continues to expand the horizons of possibility. The hierarchy of evidence-based medicine places CPGs at the top of the information pyramid, yet guidelines for common syndromic presentations like acute abdominal pain do not exist in emergency medicine. Certainly, our specialty could await others to create CPGs for these conditions, but those organizations are most likely to view patient encounters through the lens of an established or highly suspected diagnosis. In contrast, emergency physicians confront undifferentiated patients with constellations of signs and symptoms in a chaotic environment. We navigate the challenges of accurate and timely diagnosis, often with imperfect data. Paradoxically, we face expectations of constraint with testing—often without evidence-based guidance for when to safely limit workups—while avoiding critical misses. Experience with other organization's CPGs has shown that ED clinicians are often noncompliant with their recommendations, which commonly do not account for the real-life conditions of emergency care. The consequence is an unfair judgment that emergency physicians engage in inferior, non–evidence-based, and excessively costly health care by external stakeholders.20-23 The Association of Academic Chairs of Emergency Medicine's 2030 research goals focus on increasing the proportion of NIH R01-funded emergency medicine investigators, who will someday close the knowledge gap for prevalent conditions that currently remain underinvestigated.24 The absence of direct evidence and the imperfection of indirect evidence for high-priority emergency medicine CPGs illustrates the importance of forming a National Institute of Emergency Care. In addition to supporting the next generation of independent health-outcomes researchers, a central prioritizing body could ensure that the most pertinent questions affecting patient care on a daily basis are the focus of funding opportunities.19, 25 Until that day, GRACE-2 provides a synthesis of evidence and corresponding recommendations derived using GRADE methodology upon which to guide imaging and therapy decisions for adults with low-risk and recurrent abdominal pain. Medicine is equal parts science and art with clinical judgment based on hermeneutic thinking to generate a holistic understanding of an individual patient's current condition.26 Our vision is for the inclusion of direct and indirect evidence in this CPG to ground that decision making in a realistic understanding of our current state of knowledge, while catalyzing more pertinent research in the near future.

Roberto Rodríguez–Jiménez, Iluminada Corripio, Ricardo Campos, Mario Páramo · 8 authors

BACKGROUND As a consequence of the decentralization of health care provision to the different Regions (called Autonomous Communities) in Spain, different health care models and resources have been developed for psychiatric patients. It would be very useful to obtain comprehensive and comparative data on health care models, resources, and activity of acute inpatient psychiatric units (AIPUs) as a key part of mental health systems. OBJECTIVE The aim of this study was to determine the current state of AIPUs in Spain through a national scorecard that allows the current situation to be visualized in terms of resources, processes, and outputs. METHODS A 104-item online questionnaire was sent to all the AIPUs of the different Regions in Spain. It was divided into 11 sections, including data on the resources, processes, and outputs of the AIPUs plus general data, an indicator dashboard, and good practices. RESULTS The questionnaire was completed by 60.0% (117/195) of the AIPUs invited to participate. The information collected has allowed us to obtain a detailed snapshot of the current situation of AIPUs in Spain at the levels of infrastructure and material resources, staffing, organization and activity of the units, coordination with other units, guidelines, processes and protocols used, participation and communication with patients and their families, teaching activity, and research linked to the units. CONCLUSIONS This project aimed to help understand the general situation of AIPUs in Spain and its different Regions, contribute to enhancing the benchmarking and harmonization among Spanish Regions, and provide data for future comparisons with other countries. INTERNATIONAL REGISTERED REPORT RR1-10.2196/26214

Hamish Graham, Ayobami A. Bakare, Chizoba Fashanu, Owens Wiwa · 6 authors

Oxygen is one of the most basic medical therapies we have for acute respiratory illnesses and it has been an established part of medical practice for over 100 years. However, most patients who may benefit from oxygen in low- and middle-income countries will not receive it—either because oxygen is not available or because their need for oxygen is unrecognized. This gap takes an enormous toll, with modeling estimates suggesting that improved pulse oximetry and oxygen access could avert 148 000 under-five child pneumonia deaths annually in the 15 countries with the highest pneumonia burden1. This commentary explores the reasons for this gap, using Nigeria as an illustrative case study in how oxygen access can be improved globally, and concluding with key actions for policy and practice. Nigeria is a large lower middle-income country that ranks second in the number of child pneumonia deaths globally, contributing one-sixth of under-five pneumonia deaths globally.1, 2 Pneumonia causes 18% of under-five deaths in Nigeria, followed by malaria (14%), complications of prematurity (12%), neonatal encephalopathy and trauma (11%), and diarrheal diseases (10%).2 Nigerian studies suggest that hypoxemia affects approximately 14% of children admitted to hospital, including 28% to 49% of children with pneumonia and 22% to 41% of neonates.3-6 Hypoxemia ranks alongside severe acute malnutrition as a major predictor of mortality, with recent data from 12 Nigerian hospitals showing that children with hypoxemia had seven-fold higher risk of death than those who did not.3 Despite the high burden of hypoxemia and increasing recognition of its position as a key sign of illness severity, pulse oximetry, and oxygen therapy have been inadequately used in most Nigerian hospitals. Facility evaluations of Nigerian hospitals have shown that oxygen supply is often not available on pediatric wards, pulse oximeters are uncommonly used outside operating theaters, and healthcare workers lack training on how to use oxygen and pulse oximeters.7, 8 These findings in Nigeria are echoed globally. Hypoxemia is common and deadly,9, 10 yet access to oxygen and pulse oximeters remains limited and healthcare worker skills and confidence using oxygen is low11-14—especially in health centers and smaller hospitals where most sick children first present. At the hospital level, there are three key barriers to improving oxygen access and use. A recent study in 12 south-west Nigerian hospitals found that 92% (11/12) of hospitals had some access to oxygen supplies, 42% (5/12) had oxygen available on pediatric wards at the time of evaluation, and 8% (1/12) used pulse oximetry for pediatric care.7 Testing of 57 oxygen concentrators revealed that 5% (3/57) were producing medical-grade oxygen (defined as >85% purity), and 48% (24/50) of those that turned on and blew gas were simply blowing out air.7 Data from hospitals in northern Nigeria showed that the situation was even worse in these poorer, more rural, locations—11% of hospital pediatric wards had functional oxygen, 2% had pulse oximeters.8 In both regions, procurement of oxygen equipment was haphazard, motivated by price and availability of donated items, with little regard to quality or appropriateness. Hospitals lacked preventive maintenance programs and many technicians reported that they were not aware of the procurement of oxygen equipment until it was brought to them broken for repair.7 Oxygen therapy is unlike most other medications, being administered using equipment and titrated by nurses based on serial clinical assessments (including pulse oximetry). Clinical use of oxygen is not complicated, but healthcare workers do require some basic knowledge and skills. In Nigeria, most nurses receive little training on oxygen, and no training on pulse oximetry, either in nursing school or in-service training—unless they work in anesthetics/theater.7 As such, pulse oximetry is rarely used on pediatric wards, and oxygen (when it is available) is used at excessive flow rates and primarily for those with very obvious respiratory distress; many hypoxemic patients will not receive oxygen.7, 8 Maintaining supply of medical oxygen is expensive, and is made costlier by faulty equipment (eg, leaky cylinders and piping), and poor clinical practices (eg, without pulse oximetry to guide therapy). In Nigeria, oxygen-related patient fees are substantial, typically around ₦3,900 per day7 (USD$21, 2015). These costs fall most heavily on those who are sickest and require longer hospitalization and may result in treatment refusal or discharge against medical advice. In Nigeria (and many other countries), health financing deficiencies result in patients facing substantial out-of-pocket costs in accessing hospital care. The decentralized hospital system in Nigeria gives individual hospitals more autonomy and responsibility for procuring and maintaining medical equipment. However, without technical support or a strong regulatory framework, hospitals often end up with a haphazard array of cheap equipment that they are unable to maintain or repair—exacerbated further by poorly considered equipment donation programs. Nigerian clinicians, hospital administrators, and policymakers have made substantial progress towards improving oxygen access and use. At the national policy level, the Federal Ministry of Health has revised the essential medicines and equipment lists to include oxygen and oxygen-related products, updated the pneumonia clinical guidelines, created a new clinical guideline and hospital policy on oxygen,15 and developed a national strategy for scaling up oxygen nationally.16 This strategy includes the nomination of personnel in the Federal and State Ministries of Health who will be responsible for addressing oxygen access issues in their jurisdiction. Demonstration projects in Nigeria, have shown that the barriers to improving oxygen services can be overcome using existing commercially available equipment, local maintenance teams, and team-based approaches to learning and quality improvement. Results from these projects have demonstrated improved pulse oximetry use on pediatric wards (from <20% to >75%), improved oxygen provision to hypoxaemic children (from <20% to >85%), and reduced mortality from child pneumonia.17, 18 Global policies have also shifted to better support oxygen systems strengthening. In 2013, WHO/UNICEF added oxygen to the Global Action Plan for Pneumonia and Diarrhea, correcting an omission from the first edition.19, 20 This establishes oxygen therapy as a core treatment in the Protect, Prevent, Treat framework (Figure 1). In the past 4 years, the WHO has revised the Model List of Essential Medicines for Children to include oxygen for the treatment of hypoxemia in children,21 published technical specifications for concentrators22 and other oxygen therapy devices,23 and released a new oxygen clinical guidelines for children24—all of which have been used and adapted by Nigeria and other countries. Oxygen therapy is an essential medical therapy for hospital care and should be recognized as a cost-effective investment for improving health care quality and health outcomes. We identify the following key opportunities for improving oxygen therapy for children globally. First, existing evidence shows that improving oxygen systems is a cost-effective intervention that improves the quality of health services and health outcomes. Just as healthcare workers understand the value of oxygen as a basic medical therapy, policy-makers should now be able to recognize that oxygen is a sound financial investment that will make health services better overall. Better oxygen systems should not only improve access to oxygen therapy but also strengthen broader hospital quality of care systems and stimulate the adoption of other essential health technologies as well. Second, we know enough to enact national-scale implementation of improved oxygen systems. Experiences from Nigeria, Ethiopia, Papua New Guinea, and elsewhere, have identified contextual challenges and solutions to improving oxygen systems. These solutions will not be situated within vertically structured programming, but by accepting oxygen therapy as a basic hospital service within a universal health coverage agenda. Policymakers and program managers can be guided by policy documents and technical specifications from WHO and UNICEF22-24 and Every Breath Counts and United for Oxygen consortiums. However, national oxygen strategies must adopt this guidance to local contexts, defining specific responsibilities for those involved in pharmaceutical, medical device, and financing services. Third, pulse oximetry is a low-cost, relatively easily implemented, component of oxygen systems. Essential to the identification of hypoxemia, pulse oximetry is also embraced by healthcare workers as a valuable tool in assessing and monitoring sick patients that improves the quality of care more generally. As such, pulse oximetry scale-up represents “low-hanging fruit” for improving hospital care, and may also play an important role in facilitating referral from primary care.14, 25 Fourth, existing oxygen technologies are suboptimal in hot, humid, dusty conditions, or environments that lack strong maintenance structures. We need better technology to provide reliable oxygen in places where power failures are common, produce and store oxygen locally, and efficiently deliver oxygen from the oxygen source to patients. Fifth, previous studies have demonstrated the mortality impact of pulse oximetry and improved oxygen systems for young children with pneumonia, but little data exist for other children or neonates (in whom oxygen is also used commonly). The neonatal cohort represents a particular group of interest, as they can suffer adverse effects from administration of excessive oxygen (eg, retinopathy of prematurity, bronchopulmonary dysplasia).26, 27 Oxygen therapy is an essential medical therapy that is poorly available and suboptimally used in many low- and middle-income countries. Recent policy and programmatic experience in Nigeria has shown how oxygen services can be improved for the benefit of children and health services. Hamish Graham, Ayobami A. Bakare, Chizoba Fashanu, Owens Wiwa, Trevor Duke, and Adegoke G. Falade received payment for services related to this paper from the Bill and Melinda Gates Foundation (OPP1123577 and OPP1133417). HG drafted the manuscript. AAB, CF, OQ, TD, and AGF provided substantial comments to the writing of the manuscript. All authors read and approved the final manuscript.

Helen Roberts

The Family Division of the High Court exercises jurisdiction in family proceedings in England and Wales. A broadly similar jurisdiction is exercised under the Children Act in care proceedings and in private law disputes between parents by county courts and family proceedings courts. It should be emphasised that this article is about civil, not criminal, proceedings in which the burden of proof is diVerent and the practice which I describe does not apply. 2 The most recent example is the acknowledgment by the Court of Appeal that paediatricians and child psychiatrists are entitled in family proceedings to express opinions on child abuse which are based on or take into account the expert's assessment of the child's truthfulness: see Re M and R (Child Abuse: Evidence) [1996] 2 FLR 195, CA. Equally, I do not have space to address the duties of experts generally, as to which there is agreement across all the divisions of the High Court that expert evidence presented to the court should be and should be seen to be the independent product of the expert uninfluenced as to form or content by the exigencies of litigation. In Re J [1991] FCR 191 at 226/7, Cazalet J said that in children's cases the duty to be objective and not to mislead is as vital as in any case, because the child's welfare is at stake, and his/her interests are paramount. He added that an absence of objectivity may result in a child being wrongly placed and thereby unnecessarily at risk. It must also be borne in mind that a misleading opinion from an expert may well inhibit a proper assessment of a particular case by the non-medical professional advisers and may also lead parties, and in particular parents, to false views and hopes. 3 By section 12 of the Administration of Justice Act 1960, as amended by Schedule 13, para 14 of the Children Act 1989, it is a contempt of court to publish information relating to proceedings brought (inter alia) under the Children Act. 4 Oxfordshire County Council v M [1994] Fam 151, CA: Re L (A Minor) (Police Investigation) [1996] 2 WLR 395, HL. 5 By section 1(2) the court is required to have regard to the general principle that any delay in determining questions relating to the upbringing of children is likely to prejudice their welfare. 6