Adaptation Of Guidelines Research Articles

LINC-13. THE STATE OF PEDIATRIC NEURO-ONCOLOGY IN ARMENIA

BACKGROUNDEvery year in Armenia we have approximately 80–90 new pediatric cancer cases from which 10–15 are brain tumors (PBT). Here we try to summarize the current state of pediatric neuro-oncology in Armenia. DISCUSSION: In Armenia pediatric neuro-oncology is still in its first steps. Surgical treatment of PBTs is performed only in one medical center – “Sourb Astvatsamayr” Medical Center, with 7 practicing pediatric neurosurgeons. Radiation therapy service with two linear accelerators is located at the “National Oncology Center”, however there are no dedicated pediatric radiation neuro-oncologists, and 2 specialists are treating pediatric tumors. Chemotherapy for all pediatric cancers currently is performed at the Pediatric Cancer and Blood Disorders Center of Armenia, established in February 2019 as a result of merging of all pediatric oncology units in the country. Among the 11 practicing pediatric hematologist/oncologists no one is dedicated specifically to PBTs. Since September 2017 we have started discussing all PBT cases (up to now 18 cases) through the telemedicine with St. Jude Children’s Research Hospital (SJCRH). In Sept 2019 neuro-oncology multidisciplinary team was created with the involvement of local and foreign specialists. On a weekly basis the multidisciplinary team discusses all new and problematic cases. The team also concentrates on adaptation of diagnostic and treatment guidelines for pediatric CNS tumors, creation of educational materials for different stakeholders, and identification of current problems and their possible solutions.CONCLUSIONTo the best of our knowledge this is the first report summarizing the current state of pediatric neuro-oncology in Armenia.

Variations in processes for guideline adaptation: a qualitative study of World Health Organization staff experiences in implementing guidelines

BackgroundThe World Health Organisation (WHO) publishes a large number of clinical practice and public health guidelines to promote evidence-based practice across the world. Due to the variety of health system capacities and contextual issues in different regions and countries, adapting the recommendations in the guidelines to the local situation is vital for the success of their implementation. We aim to understand the range of experiences with guideline adaptation from the perspectives of those working in WHO regional and country offices. Our findings will inform development of guidance on how to improve adaptability of WHO guidelines.MethodsA grounded theory-informed, qualitative study was carried out between March 2018 and December 2018. Seventeen semi-structured interviews were conducted with participants who included WHO guideline developers and staff in the headquarters, regional and country offices recruited from a sample of published WHO guidelines. Participants were eligible for recruitment if they had recent experience in clinical practice or public health guideline implementation. Deidentified transcripts of these interview were analysed through three cycles of coding.ResultsWe categorised the adaptation processes described by the participants into two dominant models along a spectrum of guideline adaptation processes. First, the Copy or Customise Model is a pragmatic approach of either copying or customising WHO guidelines to suit local needs. This is done by local health authorities and/or clinicians directly through consultations with WHO staff. Selections and adjustments of guideline recommendations are made according to what the implementers deemed important, feasible and applicable through the consensus discussions. Second, the Capacity Building Model focuses on WHO building local capacity in evidence synthesis methods and adaptation frameworks to support local development of a national guideline informed by international guidelines.ConclusionsIn comparing and contrasting these two models of guideline adaptation, we outline the different kinds of support from WHO that may be necessary to improve the effectiveness and efficiency of the respective models. We also suggest clarifications in the descriptions of the process of guideline adaptation in WHO and academic literature, to help guideline adaptors and implementers decide on the appropriate course of action according to their specific circumstances.EthicsThis project was conducted with ethics approval from The University of Sydney (Project number: 2017/723) and WHO (Protocol ID: 00001).

Childhood Asthma: Low and Middle-Income Countries Perspective.

Our aim is to review current asthma epidemiology, achievements from the last 10 years, and persistent challenges of asthma management and control in low-middle income countries (LMICs). Despite global efforts, asthma continues to be an important public health problem worldwide, particularly in poorly resourced settings. Several epidemiological studies in the last decades have shown significant variability in the prevalence of asthma globally, but generally a marked increase in LMICs resulting in significant morbidity and mortality. Poverty, air pollution, climate change, exposure to indoor allergens, urbanization and diet are some of the factors that contribute to inadequate control and poor outcomes in developing countries. Although asthma guidelines have been developed to raise awareness and improve asthma diagnosis and treatment, problems with underdiagnosis and undertreatment are still common. In addition, important social, financial, cultural and healthcare barriers are common obstacles in LMICs in achieving control. Given the high burden of asthma in these countries, adaptation and implementation of national asthma guidelines tailored to local needs should be a public health priority. Governmental commitment, education, better health system infrastructure, access to care and effective asthma medications are the cornerstone of achieving success. CONCLUSION: Asthma poses significant challenges to LMICs. Whilst there are ongoing efforts in improving asthma diagnosis and decreasing asthma burden in LMICs; reasons for inadequate asthma control are also common and difficult to tackle. Improving asthma diagnosis, access to appropriate treatment and decreasing risk factors should be key goals to reduce asthma morbidity and mortality worldwide.

Outcome of BCMA Bite (AMG420) Therapy in Relapse and Refractory Multiple Myeloma (RRMM) Patients

Introduction The B-Cell Maturation Antigen (BCMA) serves as a target for T cell directed therapy either by CAR-T or bispecific antibodies (BiAb's) in relapsed or refractory multiple myeloma patients. ITo this end we recently reported on the outcome of the BiAb's short half life BITE® molecule (AMG420//BI 836909) targeting BCMA in RRMM patients (NCT02514239), which resulted in ORR rate of 70% at a recommend dose level of 400 mg/d (Topp et al, Vol.38. JCO 2020). Here we report on the long term outcome of our patients with medium follow up of close to 3 years. Methods In the first in human dose escalation trial with the anti-BCMA BITE® molecule AMG420/42 patients were recruited and treated with 4 weeks on and two weeks off by continuous infusion. The primary end points were DLT and MTD. Secondary end points included response per International Myeloma Working Group 2006 including the objective response rate (ORR; partial response [PR], very good PR [VGPR], complete response [CR], minimal residual disease [MRD]-negative CR) and duration of response. At our center, 23 out of 42 drug exposed study subjects were recruited and this is the reported outcome of this subgroup with respect to overall survial by ad hoc analysis (OS), progression free survival (PFS), the ORR rate, medium cycles given for non resonders versus responders, time of B-cell recovery in patients with long term control of their RRMM as well as additional safety events. Results We enrolled 23 patients out of 42 treated study patients of the Anti-BCMA BITE trial with AMG 420 in RRMM. Patients received treatment from May 2015 until June 2019 with a data cut off 3. August 2020. Among the 23 patients, who had on average 3,5 prior lines of therapy (range 2-9); 10 patients showed a response (7 CR including 5 stringent CR and 3 PR) starting from 6,5 mg/d to 400 mg/d. The OS for the entire 23 patients is 34,9 months (range from 4 to 59), the median OS for the responders was 32 months (range from 26 to 42 months) and for the 13 non responders 39 month (4- 59) with a medium follow up of 35 months. Of note, the vast majority of patients in the early dose escalation proportion of the study did not responded whereas the patients in the last cohort at 400 mg/d showed a response of 70%. The PFS was for the 10 responders 23,5 months, who received on average 7 cycles of AMG 420 with 4 patients completing 10 cycles. 2 patients are still in CR and one patient remains in continuous PR. Relapses were documented either medullary and/or extramedullary of patterns. For 5 responding patients a B cell recovery was observed on an average at 17 months after achieving a response. Post treatment recovery of B cells was seen at 6.3 months. The initial safety event of increased rate of infectious diseases led to adaption of management guidelines by including mandatory herpes virus and PcP prophylaxis. For patients with respiratory infections IgG substitution every four weeks was applied until endogenous IgG recovery was documented. No long-term severe safety events were observed. Discussion Our report of the subgroup of patients treated at our institution demonstrates that these heavily pretreated cohort of RRMM patients had a durable response of 23,5 months after AMG420 BITE® therapy. Despite this small numbers and reporting of single institutional experience these results are encouraging in light of recent long term data of BCMA CAR-T therapy reporting on a PFS of less than 12 months. The data warrante further investigation of -BCMA targeted BiAB's as a treatment modality in RRMM patients. Disclosures Topp: Amgen, Boehringer Ingelheim, KITE, Regeneron, Roche: Research Funding; Amgen, KITE, Novartis, Regeneron, Roche: Consultancy. Duell:Morphosys: Research Funding. Einsele:Janssen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Celgene: Consultancy, Honoraria, Research Funding, Speakers Bureau; Amgen: Consultancy, Honoraria, Research Funding, Speakers Bureau; Bristol-Myers Squibb: Consultancy, Honoraria, Research Funding, Speakers Bureau; Novartis: Honoraria, Speakers Bureau; Takeda: Consultancy, Honoraria, Speakers Bureau; Sanofi: Consultancy, Honoraria, Research Funding, Speakers Bureau; GlaxoSmithKline: Honoraria, Research Funding, Speakers Bureau.

Strategies for Delivering Mental Health Services in Response to Global Climate Change: A Narrative Review.

This narrative review examined strategies for preparedness and response to mental health impacts of three forms of climate change from a services perspective: (1) acute and extreme weather events such as hurricanes, floods, and wildfires, (2) sub-acute or long-term events such as droughts and heatwaves; and (3) the prospect of long-term and permanent changes, including higher temperatures, rising sea levels, and an uninhabitable physical environment. Strategies for acute events included development and implementation of programs and practices for monitoring and treating mental health problems and strengthening individual and community resilience, training of community health workers to deliver services, and conducting inventories of available resources and assessments of at-risk populations. Additional strategies for sub-acute changes included advocacy for mitigation policies and programs and adaptation of guidelines and interventions to address the secondary impacts of sub-acute events, such as threats to livelihood, health and well-being, population displacement, environmental degradation, and civil conflict. Strategies for long-lasting changes included the implementation of evidence-based risk communication interventions that address the existing and potential threat of climate change, promoting the mental health benefits of environmental conservation, and promoting psychological growth and resilience.

Cognitive Stimulation Therapy

Abstract. Cognitive stimulation therapy (CST) is a manualized psychosocial group intervention for people with mild to moderate dementia. Because of its broad scientific evidence and cost effectiveness, CST is now used globally. To ensure replicability and quality standards of the intervention in other cultures, Aguirre et al. (2014) developed guidelines for cultural adaptation of CST based on the formative method for adapting psychotherapy (FMAP). Following this community-based approach, we adapted and translated the English CST manual into German, including multiprofessional focus groups, two adaptation cycles, and two pilot CST groups ( n = 13) in different settings representative of the German healthcare system. Effectiveness in both groups was assessed by pre-post comparison of standard scales on cognition, depression, quality of life, and self-efficacy. We were able to replicate previous findings of improved cognition as measured by the ADAS-Cog, with effect sizes in the same range as in previous randomized controlled trials. Additionally, self-efficacy increased in post-test compared to the pre-test, indicating that CST might trigger cognition through positive, self-rewarding activation.

Validity and Reliability of a Thai Version of Family Satisfaction with Care in the Intensive Care Unit Survey.

PurposeTo examine reliability and validity of a Thai version of the Family Satisfaction with Intensive Care Unit (FS-ICU 24) questionnaire and use this survey in intensive care units (ICUs) in Thailand.Materials and methodsThe standard English FS-ICU questionnaire was translated into the Thai language using translation and culture adaptation guidelines. After reliability and validity testing, we consecutively surveyed the satisfaction of family members of ICU patients over 1 year. Adult family members of patients admitted to medical or surgical ICUs for 48 hours or more who had visited the patients at least once during the ICU stay were included.ResultsIn all, 315 (95%) of 332 surveys were returned from family members. Cronbach's α of the Thai FS-ICU 24 questionnaire was 0.95. Factor analysis demonstrated good construct validity. The mean (±SD) of total satisfaction score, overall ICU care subscale, and decision-making subscale were 81.5 ± 14.3, 81.0 ± 15.6, and 82.0 ± 14.0. Items with the lowest scores were the waiting room atmosphere and the frequency of doctors communicating with family members about the patient's condition. The mean total satisfaction score tended to be higher in family members of survivors than in family members of nonsurvivors (81.9 ± 13.8 vs 77.7 ± 16.2, p value = 0.059). The overall satisfaction scores between medial ICU and surgical ICU were not significantly different.ConclusionThe Thai version of FS-ICU questionnaire was found to have acceptable reliability and validity in a Thai population and can be used to drive improvements in ICU care.Trial registrationwww.clinicaltrials.in.th, TCR20160603002How to cite this articleTajarernmuang P, Chittawatanarat K, Dodek P, Heyland DK, Chanayat P, Inchai J, et al. Validity and Reliability of a Thai Version of Family Satisfaction with Care in the Intensive Care Unit Survey. Indian J Crit Care Med 2020;24(10):946–954.

Selection of Optimal Adjuvant Chemotherapy and Targeted Therapy for Early Breast Cancer: ASCO Guideline Update.

The aim of this work is to update key recommendations of the ASCO guideline adaptation of the Cancer Care Ontario guideline on the selection of optimal adjuvant chemotherapy regimens for early breast cancer and adjuvant targeted therapy for breast cancer. An Expert Panel conducted a targeted systematic literature review guided by a signals approach to identify new, potentially practice-changing data that might translate into revised guideline recommendations. The Expert Panel reviewed abstracts from the literature review and identified one article for inclusion that reported results of the phase III, open-label KATHERINE trial. In the KATHERINE trial, patients with stage I to III human epidermal growth factor receptor 2 (HER2)-positive breast cancer with residual invasive disease in the breast or axilla after completing neoadjuvant chemotherapy and HER2-targeted therapy were allocated to adjuvant trastuzumab emtansine (T-DM1; n = 743) or to trastuzumab (n = 743). Invasive disease-free survival was significantly higher in the T-DM1 group than in the trastuzumab arm (hazard ratio, 0.50; 95% CI, 0.39 to 0.64; P < .001), and risk of distant recurrence was lower in patients who received T-DM1 than in patients who received trastuzumab (hazard ratio, 0.60; 95% CI, 0.45 to 0.79). Grade 3 or higher adverse events occurred in 190 patients (25.7%) who received T-DM1 and in 111 patients (15.4%) who received trastuzumab. Patients with HER2-positive breast cancer with pathologic invasive residual disease at surgery after standard preoperative chemotherapy and HER2-targeted therapy should be offered 14 cycles of adjuvant T-DM1, unless there is disease recurrence or unmanageable toxicity. Clinicians may offer any of the available and approved formulations of trastuzumab, including trastuzumab, trastuzumab and hyaluronidase-oysk, and available biosimilars.Additional information can be found at www.asco.org/breast-cancer-guidelines.

Translation and cross-cultural adaptation of the performance-based test – Evaluation in Ayres Sensory Integration®

Background The Evaluation in Ayres Sensory Integration ® (EASI) is a performance-based assessment tool, aiming to assess sensory perception, sensory reactivity, postural/ocular/bilateral integration, and praxis in children aged 3–12 years. These types of tests are currently not available in Swedish. A structured, multistep process of translation is crucial for maintaining equivalence between the source and target version of a test. Objective Develop a culturally adapted Swedish research version of the EASI for use in the forthcoming international normative data collection. Method The translation process followed the first four stages in recommended guidelines for cross-cultural adaptation. Each subtest was translated by two occupational therapists and merged into one Swedish version. That version was reviewed by clinical paediatric occupational therapists in focus groups. The meetings were recorded, transcribed and a content analysis was conducted. One subtest was then subjected to a back-translation process. Result Some discrepancies regarding semantic equivalence were found and adapted through all stages. No discrepancies regarding idiomatic or conceptual equivalence were found. Revisions due to the translation process have been incorporated into the final research version of the EASI. Conclusion A first, culturally adapted research version of the EASI is ready for the Swedish normative data collection.

Screening, Management and Delivery in Twin Pregnancy.

The following AWMF guideline (DGGG/AGG & DEGUM responsible) deals with the diagnosis, screening and management of twins as well as the timing and mode of birth.Twin pregnancies can be classified as dichorionic diamniotic (DC DA), monochorionic diamniotic (MC DA) and monochorionic monoamniotic (MC MA) which are always monochorionic.Twin pregnancies can be concordant (both twins are affected) or discordant (only one twin is affected) for chromosomal defects, malformations, growth restriction and hemodynamic disorders.Chorionicity is the prognostically most significant parameter. Monochorial twins have significantly higher risks of intrauterine morbidity and mortality compared to dichorial twins.In particular, general aspects of twin pregnancies such as dating, determination of chorionicity and amnionicity, the labeling of twin fetuses and the perinatal switch phenomenon are discussed.Routine monitoring of MC and DC twin pregnancies with ultrasound at 11-13+ 6 weeks of gestation for chromosomal defects, invasive prenatal diagnosis, first-trimester NT or CRL discrepancies, early diagnosis of fetal anatomical defects, and management of twins with abnormalities, including selective fetocide, is described.Second trimester screening and management for preterm birth, intrauterine selective growth restriction (sFGR), classification of monochorial twins with sFGR, and management of the surviving twin after the death of the co-twin are described.Complications exclusively affecting MC twins include Twin to Twin Transfusion Syndrome (TTTS) with the important topics screening, prognosis, complications of laser therapy, timing of delivery, risks for brain abnormalities and delayed neurological development, Twin Anemia-Polycythemia Sequence (TAPS) and Twin Reversed Arterial Perfusion (TRAP) Sequence. This also includes MC MA twins as well as conjoined twins.Finally, the birth mode and time for DC and MC twin pregnancies are described.The information is summarized in 62 recommendations for action, 4 tables and 8 illustrations with comprehensive background texts.The guideline is an international guideline adaptation (ISUOG, NICE) as well as a systematic literature search and is up-to-date.

Building a Digital Tool for the Adoption of the World Health Organization's Antenatal Care Recommendations: Methodological Intersection of Evidence, Clinical Logic, and Digital Technology.

BackgroundOne of the key mandates of the World Health Organization (WHO) is to develop guidelines, defined as “a document containing recommendations for clinical practice or public health policy.” Guidelines represent the global standard for information sources shaping clinical practice and public health policies. Despite the rigorous development process and the value of guidelines for setting standards, implementing such standards within local contexts and at the point of care is a well-documented challenge. Digital technologies enable agile information management and may facilitate the adaptation of guidelines to diverse settings of health services delivery.ObjectiveThe objective of this paper is to detail the systematic and iterative process involved in transforming the WHO Antenatal Care (ANC) guidelines into a digital decision-support and patient-record application for routine use in primary health care settings, known as the WHO digital ANC module.MethodsThe WHO convened a team of clinical and digital health experts to develop the WHO digital ANC module as a tool to assist health care professionals in the implementation of WHO evidence-based recommendations for pregnant women. The WHO digital ANC module’s creation included the following steps: defining a minimum viable product (MVP), developing clinical workflows and algorithms, algorithm testing, developing a data dictionary, and the creation of a user interface or application development. The overall process of development took approximately 1 year to reach a stable prototype and to finalize the underlying content requirements of the data dictionary and decision support algorithms.ResultsThe first output is a reference software reflecting the generic WHO ANC guideline content, known as the WHO digital ANC module. Within it, all actionable ANC recommendations have related data fields and algorithms to confirm whether the associated task was performed. WHO recommendations that are not carried out by the health care worker are saved as pending tasks on a woman’s health record, and those that are adequately fulfilled trigger messages with positive reinforcement. The second output consists of the structured documentation of the different components which contributed to the development of the WHO digital ANC module, such as the data dictionary and clinical decision support workflows.ConclusionsThis is a novel approach to facilitate the adoption and adaptation of recommendations through digital systems at the health service delivery level. It is expected that the WHO digital ANC module will support the implementation of evidence-based practices and provide information for monitoring and surveillance; however, further evidence is needed to understand how the WHO digital ANC module impacts the implementation of WHO recommendations. Further, the module’s implementation will inform the WHO’s ongoing efforts to create a pathway to adaptive and integrated (Smart) Guidelines in Digital Systems to improve health system quality, coverage, and accountability.

Demographic, Clinical, and Angiographic Characteristics of Atrial Fibrillation Patients Suffering From de novo Acute Myocardial Infarction: A Subgroup Analysis of the MINOCA-TR Study Population.

Atrial fibrillation (AF) prevalence in patients with acute myocardial infarction (MI) ranges from 3% to 25%. However demographic, clinical, and angiographic characteristics of AF patients who admitted with de novo MI are unclear. The aim of this study was to investigate the prevalence of patients presenting with de novo MI with AF. The study was performed as a sub-study of the MINOCA-TR (Myocardial Infarction with Non-obstructive Coronary Arteries in Turkish Population) Registry, a multicenter, cross-sectional, observational, all-comer registry. MI patients without a known history of stable coronary artery disease and/or prior coronary revascularization were enrolled in the study. Patients were divided into AF and Non-AF groups according to presenting cardiac rhythm. A total of 1793 patients were screened and 1626 were included in the study. The mean age was 61.5 (12.5) years. 70.7% of patients were men. The prevalence of AF was 3.1% (51 patients). AF patients were older [73.4 (9.4) vs. 61.0 (12.4) years, p<0.001] than non-AF patients. The proportion of women to men in the AF group was also higher than in the non-AF group (43.1% vs. 28.7%, p=0.027). Only 1 out of every 5 AF patients (10 patients, 19.6%) was using oral anticoagulants (OAC). AF prevalence in patients presenting with de novo MI was lower than previous studies that issued on AF prevalence in MI cohorts. The majority of AF patients did not have any knowledge of their arrhythmia and were not undergoing OAC therapy at admission, emphasizing the vital role of successful diagnostic strategies, patient education, and implementations for guideline adaptation.

Cultural adaptation of the mental health first aid guidelines for assisting a person at risk of suicide to China: a Delphi expert consensus study

BackgroundSuicide is a significant public health concern in China and there is a need for evidence-based suicide prevention programs to assist people in the community who may be in a position to support those in their social networks who are at risk of suicide. English-language mental health first aid guidelines for this purpose have been developed. However, due to differences in culture, language and health systems, guidelines for English-speaking countries require cultural adaptation for use in China.MethodsA Delphi expert consensus study was conducted among mainland Chinese panellists with a diverse range of expertise in suicide crisis intervention (n = 56). Using the mental health first aid guidelines used in English-speaking countries as a basis, a questionnaire containing 141 statements on how to help a person at risk of suicide was developed and translated. Panellists were asked to rate the importance of each item for inclusion in the Chinese guidelines. They were also encouraged to suggest any additional statements that were not included in the original questionnaire. Statements were accepted for inclusion in the adapted guidelines if they were endorsed by at least 80% of panellists as essential or important.ResultsConsensus was achieved after two survey rounds on 152 statements for inclusion in the adapted guidelines for China, with 141 adopted from the guidelines for English-speaking countries and 11 generated from the comments of panellists.ConclusionsWhile the adapted guidelines were similar to the guidelines for English-speaking countries, they also incorporated actions specific to the Chinese context, including Chinese attitudes towards suicide, the role of families and friends and removal of the means of suicide. Further research is needed to investigate the use of the guidelines by the Chinese public and the implementation of Mental Health First Aid training in appropriate settings in China.

Globalization of the #chatsafe guidelines: Using social media for youth suicide prevention.

To describe the adaptation of the Australian #chatsafe guidelines for an international audience, and their initial roll out via social media. An online survey (n=48) and two workshops (n=47) conducted between August and December 2019. Thirty-eight countries were represented. Minimal adaptation of the Australian guidelines was required however, an abbreviated version and a suite of social media assets were developed. In the 6 weeks following publication the international guidelines were downloaded ~4100 times and the social media content reached over one million young people. The fact that the guidelines and campaign content appear to have had such success speaks to the need for young people to feel better equipped to communicate safely about suicide online.

Developing urban resilience in Haifa: preparedness to climate change in health and welfare agencies

Abstract Background Extreme climate events (wildfires, floods, heatwaves, cold spells) are becoming more frequent in the Mediterranean, but adaptation levels in the health and welfare sectors remain low. The city of Haifa in northern Israel is prone to both war and extreme climate events. Focusing on Haifa, we aim to 1) examine local officials' risk perceptions of different extreme events, 2) compare preparedness to war vs. climate events, and 3) conduct a spatial analysis of climate and health vulnerabilities. Methods Mixed-Methods: a qualitative component including 30 in-depth interviews with local government health and welfare officials, and a qualitative component that includes mapping vulnerability indicators such as socio-economic status, recipients of welfare allowances, and temperature, focusing on urban heat islands. Results The city of Haifa developed a comprehensive resilience policy for war and wildfire. However, there is no awareness or preparedness for other climate events that have not yet been experienced. Similarly, hospitals are prepared for emergencies, but not for extreme climate events. There are no national budget or guidelines for climate adaptation at the city level or in hospitals. Correspondingly, risk perceptions of climate change among health and welfare officials remain low. At the city level, social and climatic vulnerabilities are correlated, so that downtown neighborhoods are characterized by poorer socio-economic, health and welfare conditions, and higher summer temperatures. Conclusions Haifa has good preparedness for events that had been experienced in the past. While emergency preparedness provides a good infrastructure for climate change preparedness, awareness and adaptation to the unique aspects of climate change preparations are needed, including reference to related spatial dimensions. Identifying the gaps between preparedness to various emergency events, can contribute to better climate change preparedness at the local level. Key messages In the city of Haifa, emergency preparedness exists but is not extended to extreme climate events, and awareness to health risks of climate change remains low in the health and welfare agencies. Learning from emergency preparedness to wars, wildfires and earthquakes may contribute to enhancing preparedness to extreme climate events at the local level.

Current Topics in Idiopathic Normal Pressure Hydrocephalus:Key Points for the Revision of Guidelines for Adaptation to Super-aging Society

Current Topics in Idiopathic Normal Pressure Hydrocephalus:Key Points for the Revision of Guidelines for Adaptation to Super-aging Society

Navigational guidelines and positional relationships of the human auditory ossicles from three-dimensional topography for ensuring safe and effective malleostapedotomy : Stereotactic topography of the auditory ossicles and its clinical implication.

The aims of the present study were to identify detailed positional relationship between the auditory ossicles and to provide theoretic navigational guidelines for optimal prosthesis adaptation and effective malleostapedotomy. Fifty sides of the temporal bone from donated cadavers were scanned by MicroCT and the malleus, incus, stapes and tympanic membrane were materialized three dimensionally using computer software. Dimensions between the auditory ossicles closely related to malleostapedotomy were measured twice. The grip site of malleus handle was mean 1.8mm superior and mean 1.3mm anterior, and linear distance between the grip site of malleus handle and the footplate of the stapes was mean 6.5mm. The stapes was not parallel to the tympanic membrane and rotated mean 10.7° posteriorly relative to the tympanic membrane. Surgeons should start with at least 8.75mm prosthesis to cover the upper limits of potential anatomy and then trim down to the individualization to the case. The ideal loop morphology has to be oval shape more than 1.4mm in the long diameter and 1.0mm in the short diameter. The wire of the prosthesis has to be bended at the two points: about 10° anteriorly at the most proximal point of the wire and about 50° superiorly at the stapes head point.

Guidelines Adaptation to the COVID-19 Outbreak for the Management of Hepatocellular Carcinoma.

Background: COVID-19 pandemic rendered the surgical approach as well as the surgical indication very complex due to the outstanding consumption of public health system' resources, especially in the intensive care subdivision. A multidisciplinary team-based strategy is necessary to adapt guidelines and medical practices to the actual situation. The aim of this study is to evaluate the changes in the therapeutic algorithm in a small group of patients with hepatocellular carcinoma (HCC) enlisted for surgery during the COVID-19 outbreak. Materials and Methods: A multidisciplinary strategy has been adopted to allocate HCC patients to a treatment that permitted to reduce the risk of complications and the hospital stay, thus preventing contamination by the virus. Nasopharyngeal swab and a chest radiograph were performed in all patients within 48 hours before the surgical procedure: in the suspected cases with negative COVID tests, we prudently postponed surgery and repeated the diagnostic tests after 15 days. Results: During the emergency state, 11 HCC patients were treated (8 laparoscopic ablations and 3 hepatic resections). We reported only 1 postoperative complication (hemothorax) and 1 death during the follow-up for COVID pneumonia. Comparing our performances with those in the same time frame in the past 4 years, we treated a similar number of HCC patients, obtaining a decrease in operative timing (P = .0409) and hospital stay (P = .0412) (Fig. 2b) with similar rates of immediate postoperative complications, without ICU admissions. Conclusions: An adapted algorithm for the treatment of HCC to COVID outbreak permitted to manage safely these patients by identifying those most at risk of evolution of the neoplastic disease.

Guidelines for Robust Adaptation to Environmental Regulations in Infrastructure Projects

AbstractEnvironmental regulations can greatly affect the operation of new and existing infrastructure projects. In fact, the economic performance of infrastructure projects is closely related to en...

Future of risk based monitoring in clinical trials

&lt;p class="abstract"&gt;Drug development is a complex and resource intensive endeavor. The average cost of developing a new drug, has been estimated to be $2 to $3 billion. However, the success rate of clinical trials is very low around and is estimated to be between 3-5%. The common reasons for failure of clinical trials include failure to demonstrate efficacy or safety, budgeting and financing, failure of subjects meeting protocol eligibility criteria, poor investigator site selection, patient withdrawals and dropouts. Considering the growing demands to get better and affordable treatment options, there needs to be fundamental shift required in drug development and specifically the clinical trials oversight processes to mitigate risks and reduce failures. The International Council for Harmonisation in the E6 R2 addendumhas now provided guidelines for adaptation of risk based approach to trial conduct and monitoring to implement mitigation strategies for potential risks which might derail the conduct of the trail. The industry is steadily gearing up to put together the required processes, systems and teams to align to the new ways of working. However with the changing landscape of drug development which includes novel therapies like gene therapy, remote/decentralized trials, growing use of wearable technologies, esource, electronic health record/electronic medical records interoperability, implementation of artificial intelligence and machine learning algorithms, the future of risk based approach towards managing clinical trials is going to be very different from what we see now. This paper explores the impact of these new developments on the future of risk based monitoring in clinical trials.&lt;/p&gt;