Статті в журналах з теми "Transparent testing guidelines"

Language testing and assessment have moved center stage in recent years, whether for educational, employment, or sociopolitical reasons. More and more people are involved in developing tests and using test score outcomes, though often without a background or training in assessment to equip them adequately for this role. Simultaneously, increasing professionalization of the field has led to the generation of standards, ethical codes, and guidelines for good testing practice. Although these can help make assessment practices more transparent and accessible to a wider constituency, they also risk promoting a view of language testing as highly technical and specialized–best left to experts. These trends have implications for both policy and practice. This article reviews efforts to promote understanding of assessment within the field of applied linguistics and within education and society more broadly. The role of professional associations, academic institutions, and commercial organizations in developing assessment literacy is considered, as well as the contribution of published material and other types of training resources. This article reflects on how the international language testing community can encourage the sharing of the core knowledge, skills, and understanding that underpin good quality assessment as widely and accessibly for the benefit of all.

17000 Background: In the last decade, the Program in Evidence-based Care (PEBC), the guideline initiative of the cancer system in Ontario, Canada, has evolved dramatically. In addition to providing recommendations to facilitate decisions of clinicians (clinical practice guidelines), PEBC reports provide recommendations to facilitate decisions regarding universal drug funding, resource allocation, models of care, and the organization of the cancer system. For many of these issues, there is little in terms of traditional evidence, regardless of study design. As such, extending and building upon traditional notions of evidence and methodologies to gather new kinds of evidence have been required. Methods and Results: The PEBC has evolved the way it which conceives of evidence, the methods used to assemble and appraise evidence, and the role of evidence in decision making. To this end, environmental scan and consensus methods, in addition to standard systematic review methodology, are employed. The environmental scan methodology we use includes systematic and transparent internet searches of, and/or direct inquires to, organizations in jurisdictions determined, a priori, to be generalizable to the Ontario experience. Here, evidence comes in the form of organizational reports, case studies and evaluation data. These methods continue to be refined and tested. The consensus methodology we use is a modified Delphi technique. To date, these methods have been applied to various topics including standards for diagnostic assessment programs, surgical oncology and systemic therapy models of care, patient education, multidisciplinary case conferences, patient safety, and treatment of rare diseases. Evaluations of these reports have been generally positive (approval rating range: 56% to 75%) but noticeably more varied than approval ratings of our clinical practice guidelines that have relied primarily on traditional systematic review methodology (approval ratings rarely below 80%). Conclusions: The PEBC's notions of evidence continue to evolve as does the refinement and testing of new methodologies. Through this evolution, we are now able to provide advice on issues we would otherwise be unable to using traditional methods only, while still remaining true to our core principles of being participatory, rigorous, systematic and transparent. No significant financial relationships to disclose.

The synergies between remote sensing technologies and ecological research have opened new avenues for the study of alien plant invasions worldwide. Such scientific advances have greatly improved our capacity to issue warnings, develop early-response systems and assess the impacts of alien plant invasions on biodiversity and ecosystem functioning. Hitherto, practical applications of remote sensing approaches to support nature conservation actions are lagging far behind scientific advances. Yet, for some of these technologies, knowledge transfer is difficult due to the complexity of the different data handling procedures and the huge amounts of data it involves per spatial unit. In this context, the next logical step is to develop clear guidelines for the application of remote sensing data to monitor and assess the impacts of alien plant invasions, that enable scientists, landscape managers and policy makers to fully exploit the tools which are currently available. It is desirable to have such guidelines accompanied by freely available remote sensing data and generated in a free and open source environment that increases the availability and affordability of these new technologies. Here we present a toolbox that provides an easy-to-use, flexible, transparent and open source set of tools to sample, map, model and assess the impact of alien plant invasions using two high-resolution remote sensing products (hyperspectral and LiDAR images). This online toolbox includes a real case dataset designed to facilitate testing and training in any computer system and processing capacity.

Introduction: A novel coronavirus SARS-CoV-2 RNA, detected by reverse-transcription polymerase chain reaction (RT-PCR) was identified as the cause of a cluster of pneumonia cases in Wuhan, China. It rapidly spread, at first in China, then resulting in an epidemic in other countries throughout the world. One of such controversial topics is the issue of diagnostics and interpretation of test for COVID-19. According to Polish and global guidelines, the basis for diagnosis is molecular testing – real-time reverse transcriptasepolymerase chain reaction (RT-PCR). Taking all these data into consideration, the aim of the study was to compare RT-PCR with serological test in our employees post-exposure. According to Polish and global guidelines, the basis for diagnosis is molecular testing, real-time reverse transcriptase-polymerase chain reaction (RT-PCR). The aim: To compare RT-PCR with serological test in our employees post-exposure. Material and methods: 79 employees of the Clinic, 19 men and 60 women in the age range 27-69 years were evaluated. Tests were begun four days after information about the positive test in our „Employee 0” and lasted for 7 days. At first, we made RT-PCR tests on the specimen from nasopharyngeal swab. Then, we accomplished rapid antibodies tests. This test is based on the qualitative assessment of the presence of IgM and IgG antibodies by immunochromatography using a sample of capillary blood from the fingertip. Results: All the tests were negative. No employee developed symptoms during the 7-day follow-up after the end of the tests. Conclusions: As routine tests for patients have been implemented widely, but similar solutions for employees have not gained popularity. Use of personal protective equipment (PPE) e.g. facemask and shields, transparent screens, disposable medical uniforms, minimalization the contact time, increasing distance from both colleagues and patients (if possible), and strictly follow sanitary procedures largely contributed to the absence of illness in the surveyed group of employees.

At the beginning of the coronavirus disease-19 pandemic, health care staff at a level 1 trauma center in the state of New York experienced facial irritation and skin breakdown under their N95 respirators due to increased and prolonged use. PURPOSE: Members of the Certified Wound and Ostomy Nurse, Nurse Practitioners staff were charged with developing recommendations within 48 hours to help prevent and manage facial skin issues using available products that would not compromise the seal of the respirators. METHOD: With the assistance of a health care safety specialist from the Environmental Health and Safety Department of the hospital, an ambient particle counting device was used to measure the N95 fit factor following application of a liquid skin barrier, transparent film dressing, light silicone-based adhesive dressing, or an extra-thin hydrocolloid dressing on the bridge of the nose and the cheekbones underneath an N95 respirator of 2 hospital staff members who volunteered to test the dressings. RESULTS: All thin dressings tested showed a fit factor over 100, reflecting an effective seal. The highest fit factors were seen with the liquid skin barrier in the 2 volunteers (200 and 198, respectively). Thin dressing usage information was included in the hospital guidelines for N95 respirators and shared with staff. Subsequent feedback suggests that the light silicone-based adhesive dressing and the extra-thin hydrocolloid dressing were preferred. CONCLUSION: Thin dressing use may help reduce skin complications among hospital staff during periods of extended N95 respirator wear time. Because use of the dressings did not result in failure of the quantitative fit test, they were permitted for use by health care staff under their N95 respirators. Studies are needed to help health care facilities optimize N95 respirator use to protect staff from coronavirus disease-19 and respirator-related skin complications while supply shortages remain.

Contemporary theory of argumentation offers many insights about the ways in which, in the context of a public controversy, arguers should ideally present their arguments and criticize those of their opponents. We also know that in practice not all works out according to the ideal patterns: numerous kinds of derailments (fallacies) are an object of study for argumentation theorists. But how about the use of unfair strategies vis-à-vis one’s opponents? What if it is not a matter of occasional derailments but of one party’s systematic refusal to take other parties seriously? What if one party continually forgoes any form of critical testing and instead resorts to threats or blackmail? Can this be countered by the tools of reason? Or should one pay one’s opponent back in the same coin? To gain some grasp of these issues, we describe a number of strategies used in the public controversy about induced earthquakes in Groningen. We check whether these strategies are fair, i.e. balanced, transparent, and tolerant. We also investigate the effects of the choice for a particular kind of strategy. It appears that, in circumstances, choosing a fair strategy may be detrimental for resolving the controversy and choosing an unfair one beneficial. Following up ideas from social psychology and political science, we formulate some guidelines for the choice of strategies. At the end, we stress the importance — especially for those whose opinions carry little weight — of having a society in which the knowledge and skills needed for assessing the fairness of strategies are widespread.

Dose articulation is a universal issue of intervention development and testing. In stroke recovery, dose of a nonpharmaceutical intervention appears to influence outcome but is often poorly reported. The challenges of articulating dose in nonpharmacological stroke recovery research include: (1) the absence of specific internationally agreed dose reporting guidelines; (2) inadequate conceptualization of dose, which is multidimensional; and (3) unclear and inconsistent terminology that incorporates the multiple dose dimensions. To address these challenges, we need a well-conceptualized and consistent approach to dose articulation that can be applied across stroke recovery domains to stimulate critical thinking about dose during intervention development, as well as promote reporting of planned intervention dose versus actually delivered dose. We followed the Design Research Paradigm to develop a framework that guides how to articulate dose, conceptualizes the multidimensional nature and systemic linkages between dose dimensions, and provides reference terminology for the field. Our framework recognizes that dose is multidimensional and comprised of a duration of days that contain individual sessions and episodes that can be active (time on task) or inactive (time off task), and each individual episode can be made up of information about length, intensity, and difficulty. Clinical utility of this framework was demonstrated via hypothetical application to preclinical and clinical domains of stroke recovery. The suitability of the framework to address dose articulation challenges was confirmed with an international expert advisory group. This novel framework provides a pathway for better articulation of nonpharmacological dose that will enable transparent and accurate description, implementation, monitoring, and reporting, in stroke recovery research.

Objective: The development of these guidelines is sponsored by the American Association of Clinical Endocrinologists (AACE) Board of Directors and American College of Endocrinology (ACE) Board of Trustees and adheres with published AACE protocols for the standardized production of clinical practice guidelines (CPG). Methods: Recommendations are based on diligent reviews of clinical evidence with transparent incorporation of subjective factors, according to established AACE/ACE guidelines for guidelines protocols. Results: The Executive Summary of this 2019 updated guideline contains 58 numbered recommendations: 12 are Grade A (21%), 19 are Grade B (33%), 21 are Grade C (36%), and 6 are Grade D (10%). These detailed, evidence-based recommendations allow for nuance-based clinical decision-making that addresses multiple aspects of real-world care of patients. The evidence base presented in the subsequent Appendix provides relevant supporting information for the Executive Summary recommendations. This update contains 357 citations of which 51 (14%) are evidence level (EL) 1 (strong), 168 (47%) are EL 2 (intermediate), 61 (17%) are EL 3 (weak), and 77 (22%) are EL 4 (no clinical evidence). Conclusion: This CPG is a practical tool that practicing endocrinologists and regulatory bodies can refer to regarding the identification, diagnosis, and treatment of adults and patients transitioning from pediatric to adult-care services with growth hormone deficiency (GHD). It provides guidelines on assessment, screening, diagnostic testing, and treatment recommendations for a range of individuals with various causes of adult GHD. The recommendations emphasize the importance of considering testing patients with a reasonable level of clinical suspicion of GHD using appropriate growth hormone (GH) cut-points for various GH–stimulation tests to accurately diagnose adult GHD, and to exercise caution interpreting serum GH and insulin-like growth factor-1 (IGF-1) levels, as various GH and IGF-1 assays are used to support treatment decisions. The intention to treat often requires sound clinical judgment and careful assessment of the benefits and risks specific to each individual patient. Unapproved uses of GH, long-term safety, and the current status of long-acting GH preparations are also discussed in this document. LAY ABSTRACT This updated guideline provides evidence-based recommendations regarding the identification, screening, assessment, diagnosis, and treatment for a range of individuals with various causes of adult growth-hormone deficiency (GHD) and patients with childhood-onset GHD transitioning to adult care. The update summarizes the most current knowledge about the accuracy of available GH–stimulation tests, safety of recombinant human GH (rhGH) replacement, unapproved uses of rhGH related to sports and aging, and new developments such as long-acting GH preparations that use a variety of technologies to prolong GH action. Recommendations offer a framework for physicians to manage patients with GHD effectively during transition to adult care and adulthood. Establishing a correct diagnosis is essential before consideration of replacement therapy with rhGH. Since the diagnosis of GHD in adults can be challenging, GH–stimulation tests are recommended based on individual patient circumstances and use of appropriate GH cut-points. Available GH–stimulation tests are discussed regarding variability, accuracy, reproducibility, safety, and contraindications, among other factors. The regimen for starting and maintaining rhGH treatment now uses individualized dose adjustments, which has improved effectiveness and reduced reported side effects, dependent on age, gender, body mass index, and various other individual characteristics. With careful dosing of rhGH replacement, many features of adult GHD are reversible and side effects of therapy can be minimized. Scientific studies have consistently shown rhGH therapy to be beneficial for adults with GHD, including improvements in body composition and quality of life, and have demonstrated the safety of short- and long-term rhGH replacement. Abbreviations: AACE = American Association of Clinical Endocrinologists; ACE = American College of Endocrinology; AHSG = alpha-2-HS-glycoprotein; AO-GHD = adult-onset growth hormone deficiency; ARG = arginine; BEL = best evidence level; BMD = bone mineral density; BMI = body mass index; CI = confidence interval; CO-GHD = childhood-onset growth hormone deficiency; CPG = clinical practice guideline; CRP = C-reactive protein; DM = diabetes mellitus; DXA = dual-energy X-ray absorptiometry; EL = evidence level; FDA = Food and Drug Administration; FD-GST = fixed-dose glucagon stimulation test; GeNeSIS = Genetics and Neuroendocrinology of Short Stature International Study; GH = growth hormone; GHD = growth hormone deficiency; GHRH = growth hormone–releasing hormone; GST = glucagon stimulation test; HDL = high-density lipoprotein; HypoCCS = Hypopituitary Control and Complications Study; IGF-1 = insulin-like growth factor-1; IGFBP = insulin-like growth factor–binding protein; IGHD = isolated growth hormone deficiency; ITT = insulin tolerance test; KIMS = Kabi International Metabolic Surveillance; LAGH = long-acting growth hormone; LDL = low-density lipoprotein; LIF = leukemia inhibitory factor; MPHD = multiple pituitary hormone deficiencies; MRI = magnetic resonance imaging; P-III-NP = procollagen type-III amino-terminal pro-peptide; PHD = pituitary hormone deficiencies; QoL = quality of life; rhGH = recombinant human growth hormone; ROC = receiver operating characteristic; RR = relative risk; SAH = subarachnoid hemorrhage; SDS = standard deviation score; SIR = standardized incidence ratio; SN = secondary neoplasms; T3 = triiodothyronine; TBI = traumatic brain injury; VDBP = vitamin D-binding protein; WADA = World Anti-Doping Agency; WB-GST = weight-based glucagon stimulation test

Low rates of reproducibility and translatability of data from nonclinical research have been reported. Major causes of irreproducibility include oversights in study design, failure to characterize reagents and protocols, a lack of access to detailed methods and data, and an absence of universally accepted and applied standards and guidelines. Specific areas of concern include uncharacterized antibodies and cell lines, the use of inappropriate sampling and testing protocols, a lack of transparency and access to raw data, and deficiencies in the translatability of findings to the clinic from studies using animal models of disease. All stakeholders—academia, industry, funding agencies, regulators, nonprofit entities, and publishers—are encouraged to play active roles in addressing these challenges by formulating and promoting access to best practices and standard operating procedures and validating data collaboratively at each step of the biomedical research life cycle.

Abstract Preclinical hemolysis testing is a critical requirement toward demonstrating device safety for U.S. Food and Drug Administration (FDA) 510(k) approval of mechanical circulatory support devices (MCSD). FDA and ASTM (formerly known as the American Society for Testing and Materials) have published guidelines to assist industry with developing study protocols. However, there can be significant variability in experimental procedures, study design, and reporting of data that makes comparison of test and predicate devices a challenge. To overcome these limitations, we present a hemolysis testing protocol developed to enable standardization of hemolysis testing while adhering to FDA and ASTM guidelines. Static mock flow loops primed with fresh bovine blood (600 mL, Hematocrit = 27±5%, heparin titrated for ACT >300 sec) from a single-source donor were created as a platform for investigating test and predicate devices. MCSD differential pressure and temperature were maintained at 80 mmHg and 25°±2° C. Blood samples (3 ml) were collected at 0, 5, 90, 180, 270, 360 minutes to measure CBC and plasma free hemoglobin. This protocol led to 510(k) approval of two adult MCSD and has been used to test novel cannulae and a pediatric MCSD. Standardization of hemolysis testing procedures and transparency of results may enable better blood trauma characterization of MCS devices to facilitate the FDA 510(k) and PMA submission processes and improve clinical outcomes.

Background: Current fitting guidelines from the American Academy of Audiology (Academy) support the use of objective electroacoustic measures and behavioral testing when fitting frequency modulation (FM) systems to hearing aids. However, only behavioral testing is recommended when fitting FM systems to individuals with cochlear implants (CIs) because a protocol for conducting electroacoustic measures has yet to be developed for this population. Purpose: The purpose of this study was to propose and examine the validity of a newly developed, objective, electroacoustic test protocol for fitting electrically and electromagnetically coupled FM systems to CI sound processors. Research Design: Electroacoustic measures were conducted and replicated in the laboratory with three contemporary CI sound processors and several FM system combinations. A repeated measures design was used with four participants to examine the validity of the proposed electroacoustic test protocol. Study Sample: Three contemporary CI sound processors were tested electroacoustically in the laboratory while coupled to combinations of five FM receivers and four FM transmitters. Two adolescents using Cochlear Nucleus 5 sound processors and two adult participants using MED-EL OPUS 2 sound processors completed behavioral and subjective measures. Data Collection and Analysis: Using current hearing aid practice guidelines from the Academy, electroacoustic measurements were conducted in the laboratory with the CIs and FM systems to determine transparency, where equivalent inputs to the CI and FM microphones result in equivalent outputs. Using a hearing aid analyzer, acoustic output from the CI sound processor was measured via monitor earphones and specialized equipment from CI manufacturers with 65 dB SPL speech inputs (1) to the sound processor and (2) to the FM transmitter microphones. The FM gain or volume was adjusted to attempt to achieve transparency for outputs from the two input devices. The four participants completed some or all of the following measures: speech recognition in noise without and with two FM systems in a classroom, loudness ratings without and with two FM systems measures in a quiet condition in a classroom, and questionnaires. Results: Transparency was achieved for most CI and FM combinations, but most systems required adjustments to FM gain or volume relative to the manufacturer default setting. Despite adjustments to the systems, transparency was not attainable for some FM receiver and transmitter combinations. Behavioral testing in four participants provided preliminary support to the proposed electroacoustic test protocol. Conclusions: Valid and reliable electroacoustic test measures may be feasible with CIs coupled to FM systems with specialized equipment from the CI manufacturer. Advances in equipment available for electroacoustic testing with these devices as well as additional research will lend further support to this objective approach to fitting FM systems to CIs.

At the time of onset of regional autonomy in the hope that emerges is more independent local governments in the implementation of government activities and conduct development in their respective areas. Government Regulation Number 24 of 2005 Government Accounting Standards neighbor besides achieving good governance is also the answer to anticipation the financial reporting guidelines that can be generally accepted.The research was conducted at the head and the staff involved in the process of financial management in the Government District Talaud Islands. This study aimed to determine the effect of financial statement presentation and accessibility to transparency and accountability in government financial management goverment Talaud Islands.Data analysis method used is the method of multiple linear regression, descriptive statistics test, test validity and reliability testing, test assumptions of classical, hypothesis testing ( F test and t test ) , the coefficient of determination ( R ² ) . To complete the overall data analysis used SPSS 20.0 software.The results show the financial statement presentation and accessibility significantly affect the transparency and accountability of financial management. It can be seen from the equation Y = 5,425 + + 0.579X1 0.094X2. Of multiple linear regression equation shows that the financial statement presentation and accessibility positive effect on transparency and accountability in the management of the financial statements. The correlation coefficient ( R ) obtained for 65.3% and the coeffi cient of determination ( R ² ) of 42.7% and the remaining 57.3% or other variables not examined in this study. Results of hypothesis testing ( F test ) showed a significance value of 0.000 at the significant level α = 0.05 level test results mean F states H0 rejected Ha accepted. And ( t test ) showed for the variable X1 ( Regions Financial Statements ) significant value for 0000 with a significant level of α = 0.05 then H0 is rejected means-Ha is accepted, it means the area of financial statement presentation variables significantly affect the transparency and accountability of financial management. For the variable X2 ( Aksesibilitan Regional Financial Statements ) significant value of 0.526 with a significant level of α = 0.05 then H0 is accepted means Ha rejected, meaning that the variable with Regional Financial Statements do not significantly affect the Transparency and Accountability of Financial Management.

Purpose: The growing public interest in vocational education and training (VET), most recently since the economic crisis of 2007/2008, has led to an exponential increase in articles with a vocational focus, underscoring the need for review studies for the purposes of systematic knowledge aggregation, clarification and interpretation. We assume that review studies follow the same minimum standards as other research methods: The review must be at least reproducible and thus the results verifiable or falsifiable. So far, however, the review methods used in VET research have not been investigated. Our purpose is to review the review procedures and methods used in published reviews of VET research to identify their current methodological quality. Approach: To classify the review studies, we initially developed a conceptual framework to distinguish different types of reviews. We then developed a methodological framework to assess the review methods used. Overall, to accelerate the review process, our review of reviews (or umbrella review) followed the rapid review approach: we limited our search to reviews in English published between 2014 and 2019 in peer-reviewed journals with a sub-stantial VET focus and indexed in Scopus and/or Web of Science. Therefore, we did not examine all existing reviews in the field of VET research. Rather, our specific focus was on a core sector of scientific research: peer-reviewed articles in curated databases. Furthermore, we concentrated on the review procedures and methods used, not on the content of the reviews. Findings: We identified nine journals with a substantial VET focus, yielding a total of 1,283 published articles between 2014 and 2019, of which only 19 articles (1.48%) were literature reviews. Of these 19 reviews, six were excluded from our umbrella review because of unclear methodological procedures. Based on the review typology we developed, five of the remaining 13 reviews were conceptual in nature, four were scoping reviews, three were evidence-oriented, and one was critical in nature. None of the reviews examined focused on meta-syntheses, research methods or meta-analyses. In total, this resulted in current review gaps with respect to theory generation (meta-synthesis), practice of theory elaboration and testing (methodological review) and the determination of overall effects across single studies (meta-analysis). Finally, our examination of the reviews showed that their scope was mostly clearly presented. However, with regard to the process steps ‘data selection’ and ‘data processing’, only a few reviews fully met the requirements of the methodological framework.Conclusion: Our review leads to four conclusions. 1) More systematic syntheses are needed because there is a substantial quantitative gap in review research. 2) In particular, there is a need for review studies with a focus on meta-synthesis, research methods and meta-analysis, as there is a current gap in these areas. 3) Reviews should be based on a review methodology with transparent and reproducible methods and verifiable or falsifiable results. The high number of subjective syntheses with unclear review procedures indicates that this mindset is not yet fully established in the field of VET research. 4) In the studies examined, there is a high degree of heterogeneity regarding to the accuracy and completeness of the methodological steps and data. The conceptual and methodological frameworks developed for the analysis can serve as guidelines for the conduct of reviews, and thus, the frameworks could contribute to the further development of the methodological basis of reviews.

Purpose: The growing public interest in vocational education and training (VET), most recently since the economic crisis of 2007/2008, has led to an exponential increase in articles with a vocational focus, underscoring the need for review studies for the purposes of systematic knowledge aggregation, clarification and interpretation. We assume that review studies follow the same minimum standards as other research methods: the review must be at least reproducible and thus the results verifiable or falsifiable. So far, however, the review methods used in VET research have not been investigated. Our purpose is to review the review procedures and methods used in published reviews of VET research to identify their current methodological quality. Approach: To classify the review studies, we initially developed a conceptual framework to distinguish different types of reviews. We then developed a methodological framework to assess the review methods used. Overall, to accelerate the review process, our review of reviews (or umbrella review) followed the rapid review approach: we limited our search to reviews in English published between 2014 and 2019 in peer-reviewed journals with a substantial VET focus and indexed in Scopus and/or Web of Science. Therefore, we did not examine all existing reviews in the field of VET research. Rather, our specific focus was on a core sector of scientific research: peer-reviewed articles in curated databases. Furthermore, we concentrated on the review procedures and methods used, not on the content of the reviews. Findings: We identified nine journals with a substantial VET focus, yielding a total of 1,283 published articles between 2014 and 2019, of which only 19 articles (1.48%) were literature reviews. Of these 19 reviews, six were excluded from our umbrella review because of unclear methodological procedures. Based on the review typology we developed, five of the remaining 13 reviews were conceptual in nature, four were scoping reviews, three were evidence-oriented, and one was critical in nature. None of the reviews examined focused on meta-syntheses, research methods or meta-analyses. In total, this resulted in current review gaps with respect to theory generation (meta-synthesis), practice of theory elaboration and testing (methodological review) and the determination of overall effects across single studies (meta-analysis). Finally, our examination of the reviews showed that their scope was mostly clearly presented. However, with regard to the process steps ‘data selection’ and ‘data processing’, only a few reviews fully met the requirements of the methodological framework.Conclusion: Our review leads to four conclusions. 1) More systematic syntheses are needed because there is a substantial quantitative gap in review research. 2) In particular, there is a need for review studies with a focus on meta-synthesis, research methods and meta-analysis, as there is a current gap in these areas. 3) Reviews should be based on a review methodology with transparent and reproducible methods and verifiable or falsifiable results. The high number of subjective syntheses with unclear review procedures indicates that this mindset is not yet fully established in the field of VET research. 4) In the studies examined, there is a high degree of heterogeneity regarding to the accuracy and completeness of the methodological steps and data. The conceptual and methodological frameworks developed for the analysis can serve as guidelines for the conduct of reviews, and thus, the frameworks could contribute to the further development of the methodological basis of reviews.

The rapid spread of COVID-19 has generated a demand for health-related safety equipment. The development of these emergency products raises several questions, in particular the possible lack of concern for health, satisfaction, and safety of users in addition to the immediate safety against the COVID-19. Considering these issues, the objectives of this work are to categorize, identify trends, and propose strategic approaches to the development and alteration of individual and collective safety solutions for facing the pandemic. For that, we conducted a review and categorization of industrial design products developed during the pandemic using the database Behance. We found 171 developed products. Of these, we classified 99 as individual safety solutions, with the majority being masks and face shields, 59 as being collective safety solutions like disinfection booths, physical transparent separators, and sanitary dispensers. And 13 were solutions geared to hospital use such as hospital furniture, testing solutions, and medical safety procedures. From the analysis of these products, we noted four major themes: protection from the infection, isolation, and physical barriers for enabling safe interaction, disinfection, and testing that can be used as a strategic guideline for the development of new solutions for this context.

Purpose This paper aims to investigate whether the key items encompassed in the new reporting trends are addressed in the current reporting set and, also, whether there are certain patterns regarding disclosure practices across a sample of reporting entities. Design/methodology/approach The research methodology takes into consideration both the financial and non-financial elements from the entities’ activities and embeds them in the analysis, in a more holistic frame offered by integrated reporting. The disclosure level is investigated using the six-tier capital model from the International Integrated Reporting Council Framework and the eight major principles from GRI guidelines. Furthermore, the cluster analysis is used to identify the disclosure practices patterns within some European Union local public administrations. Findings The level of disclosure within the analyzed entities is relatively high. Also, the results of the cluster analysis reveal some disclosure patterns, especially regarding the Anglo-Saxon and Northern local public administrations, the municipalities with the highest degree of disclosure of the sample. Research limitations/implications The most significant limitations are represented by the sample of municipalities, the language filter and the fact that only one-year data were considered for analysis. Practical implications The study can be useful to any other institutions under the dome of the public sector, willing to enhance public accountability throughout greater transparency. Also, it might help the public managers to outline a long-term development plan about how to create value and to whom, material issues, risks and strategy through the integrated reporting, a cornerstone for future changes. Moreover, it might also be a subject of interest in the research environment, offering new opportunities for further empirical studies, by applying and testing it in other public organizations. Originality/value The study provides an original assessment tool useful to improving the reporting process. Also, it can be useful to other public institutions that are willing to enhance public accountability throughout greater transparency.

Parliaments represent the interests of citizens, and so remain critical to democracy and good governance. Therefore, for effective citizens’ engagement, ensuring online presence, and enhancing transparency of internal processes, parliaments’ leverage on Information and Communication Technology is of paramount importance globally. This study investigates the contents of official parliamentary websites in the 36 State Houses of Assembly of Nigeria to determine how they facilitate effective engagement between citizens and their elected representatives. The methodology used includes manual testing based on categories and critical sub-factors in line with Inter-Parliamentary Union (IPU) Guidelines. Desk research was also used to determine technical challenges for the implementation of e-parliament. The findings reveal that only 36% of the State Assemblies have official websites. Five are fully functional, and just five state legislatures effectively utilize interactive tools to re-engage the citizens. Results show that 58% of the state legislatures use social media tools such as Facebook and Twitter. The authors conclude that in enhancing civic participation, state legislatures need to provide a relatively open, more responsive, accessible, and interactive website while extending social medial tools.

The Summary of Product Characteristics (SmPC) is an obligatory document concerning a medicine required (among other things) for the authorization of a medicinal product. The purpose of the SmPC is to provide product information to healthcare professionals. A necessary condition for this is to ensure that the SmPC is clear and precise. However, neither European nor national legislation obliges marketing authorization holders to review the SmPC in terms of its readability and understandability prior to the registration of a medicine. To date, research on SmPCs has focused on accuracy and completeness; however, the literature lacks information on the extent to which SmPCs meet the needs of healthcare professionals concerning the readability of the information they contain. The main objective of this article is to point out the lack of precision in the legal provisions for the preparation of SmPCs concerning the comprehensibility of the provisions. The article points to the lack of testing of the SmPC in terms of accessibility and transparency for healthcare professionals, highlighting that the document does not meet the needs of healthcare professionals in providing adequate information about medicines. It shows that the current rules and guidelines for the preparation of the registration dossier for a medicinal product are not entirely precise and contain numerous shortcomings.

In remote sensing, the term accuracy typically expresses the degree of correctness of a map. Best practices in accuracy assessment have been widely researched and include guidelines on how to select validation data using probability sampling designs. In practice, however, probability samples may be lacking and, instead, cross-validation using non-probability samples is common. This practice is risky because the resulting accuracy estimates can easily be mistaken for map accuracy. The following question arises: to what extent are accuracy estimates obtained from non-probability samples representative of map accuracy? This letter introduces the T index to answer this question. Certain cross-validation designs (such as the common single-split or hold-out validation) provide representative accuracy estimates when hold-out sets are simple random samples of the map population. The T index essentially measures the probability of a hold-out set of unknown sampling design to be a simple random sample. To that aim, we compare its spread in the feature space against the spread of random unlabelled samples of the same size. Data spread is measured by a variant of Moran’s I autocorrelation index. Consistent interpretation of the T index is proposed through the prism of significance testing, with T values < 0.05 indicating unreliable accuracy estimates. Its relevance and interpretation guidelines are also illustrated in a case study on crop-type mapping. Uptake of the T index by the remote-sensing community will help inform about—and sometimes caution against—the representativeness of accuracy estimates obtained by cross-validation, so that users can better decide whether a map is fit for their purpose or how its accuracy impacts their application. Subsequently, the T index will build trust and improve the transparency of accuracy assessment in conditions which deviate from best practices.

With marine diseases on the rise and increased reliance on molecular tools for disease surveillance, validated pathogen detection capabilities are important for effective management, mitigation, and response to disease outbreaks. At the same time, in an era of continual evolution and advancement of molecular tools for pathogen detection, it is critical to regularly reassess previously established assays to incorporate improvements of common practices and procedures, such as the minimum information for publication of quantitative real-time PCR experiments (MIQE) guidelines. Here, we reassessed, re-optimized, and improved the quantitative PCR (qPCR) assay routinely used for Quahog Parasite Unknown (QPX) disease monitoring. We made 19 significant changes to the qPCR assay, including improvements to PCR amplification efficiency, DNA extraction efficiency, inhibition testing, incorporation of linearized standards for absolute quantification, an inter-plate calibration technique, and improved conversion from copy number to number of cells. These changes made the assay a more effective and efficient tool for disease monitoring and pathogen detection, with an improved linear relationship with histopathology compared to the previous version of the assay. To support the wide adoption of validated qPCR assays for marine pathogens, we provide a simple workflow that can be applied to the development of new assays, re-optimization of old or suboptimal assays, or assay validation after changes to the protocol and a MIQE-compliant checklist that should accompany any published qPCR diagnostic assay to increase experimental transparency and reproducibility amongst laboratories.

Aim/Purpose: Grounded Theory (GT) has grown and developed into several strands making its application all the more problematic, argumentative and remaining potentially as a research methodology to avoid when it comes to doctoral research, early-career research. Thus, the purpose of this paper is to revisit GT as a general approach and present an evolved and more considered step-by-step guide to conduct research using this methodology. A leadership development context is applied in this paper to examine how this methodology could work for a new generation of researchers, i.e., new to doctoral research or an early career researcher. Background: Since its academic inception in the seminal text in 1967 (Glaser & Strauss, 1967), GT has emerged and developed to become a popular choice for researchers contemplating qualitative data approaches amongst a variety of subject backgrounds. However, the divergent development and criticized approaches within GT families can lead researchers to avoid such a research methodology. This can especially be the case within doctoral research or other early-career research. Indeed, a specific/explicit GT guideline or framework to assist doctoral students in conducting GT research does not currently exist. Methodology: There is a general review of GT approaches followed by theoretical development of a framework and an applied doctoral example. Contribution: The three evolved methods in GT research and the developed supporting author-designed three-phase research framework will contribute to two aspects. Firstly, the step-by-step guideline can reduce the sense of confusion within an area where criticisms and conflicting approaches exist. This will hopefully assist the next generation of GT researchers in conducting their research through detailed processes and applications. Secondly, there is arguably a need for more GT applications and evolvements to further enrich the body of knowledge that exists in this area and further support a diversity of subject research. Findings: The authors outline numerous differences and similarities within divergent GT practices. By integrating Glaser’s four core principles and three evolved methods, the authors design a three-phase research framework that presents a transparent step-by-step guide. This framework attempts to mitigate criticisms within GT approaches whilst maintaining clarity, flexibility, depth, and rigour within a study. Recommendations for Practitioners: Three GT evolvements (the two-step literature review method, two-step open-coding method, and two-step theory-constitute method) provides greater clarity within a rigorous author-designed three-phase research framework that demonstrates a transparent step-by-step guide. These techniques can encourage a new generation of GT researcher through confident and structured analytical techniques. Recommendation for Researchers: We hope the presented framework and concise view of GT in action will inspire other doctoral students and new GT researchers to conduct GT research following an evolved GT framework. Impact on Society: The debates and innovations around GT, like in this paper, are needed within a methodological society to keep the area contemporary and constantly evolving. Future Research: The framework presented will need further testing beyond the parameters set out here. We hope future research can adopt the evolved GT techniques and procedures to enforce research quality overall and inspire further GT methodological developments.

Aim/Purpose: This study is carried out to determine the factors influencing the implementation of IT governance in public sector. Background: IT governance in organizations plays strategic roles in deciding whether IT strategies and investments of both private and public organizations could be efficient, consistent, and transparent. IT governance has the potential to be the best practice that could improve organizational performance and competency. Methodology: The study involves qualitative and quantitative approaches, where data were collected through questionnaire, observation, interview, and document study through a sample of 367 respondents. The collected data were analyzed using Structured Equation Modeling (SEM) for validating the model and testing the hypotheses. Besides, semi-structured interview, observation, and document study were also carried out to obtain the management’s feedback on the implementation of IT governance and its activities. Contribution: The results of this study contribute to knowledge regarding good IT governance. Practically, this study can be used as a guideline for the future development and good IT governance. Findings: The findings reveal that policy has a significant direct influence on system planning, the management of IT investment, system realization, operation and maintenance, and organizational culture. The existence of IT governance policies, the success of the IT process can work well. Monitoring and evaluation processes also significantly affect system plan-ning, management of IT investment, system realization, operation and maintenance, and organizational culture. It indicates the process of monitoring and evaluation required for indications of financial efficiency, infrastructure, resources, risk and organizational success. Recommendations for Practitioners: It is important for organizational management to pay more attention to the organization’s internal controls in order to create good IT governance. Recommendation for Researchers: A comparative study between Indonesia and developing countries on the implementation of IT governance is needed to capture the differences be-tween those countries. Impact on Society: Knowledge of the factors influencing the implementation of IT governance as an effort to implement and improve the quality of IT governance. Future Research: Future studies should look further at the policy and IT governance models, specifically in public organizations, besides other influencing factors. Moreover, the outcome of this study could be generated as a guideline for the advanced development of IT governance and as a point of improvement as a way to generate a better good IT governance. It is essential because such evidence is lacking in current literature.

Background: The hallmark of Middle East respiratory syndrome coronavirus (MERS-CoV) disease is the ability to cause major healthcare-associated outbreaks with superspreading events leading to massive transmission and excessive morbidity and mortality. This abstract provides overview of MERS-CoV multi-healthcare facilities outbreak in Riyadh in June 2017, with focus on cluster reported and the control measures taken at King Saud Medical City. The outbreak began with a patient who presented with acute renal failure requiring hemodialysis and became a MERS-CoV superspreader, igniting the cluster of cases in several hospitals in King Saud Medical City. Methods: For epidemiologic investigation, a case was defined as any patient with laboratory-confirmed MERS-CoV infection with connection to the affected healthcare facilities. Contact tracing and testing were performed according to the Ministry of Health (MOH) guidelines. MERS-CoV testing was recommended for HCWs who had unprotected close contact with a confirmed case. Considering the superspreading phenomena, contact tracing was included all persons attended the same area with the positive case either as a patient, an HCW, or a patient’s visitor or companion. Laboratory confirmation was conducted using real-time RT-PCR. Genome sequencing and phylogenetic analysis were performed for available MERS-CoV rRT-PCR–positive samples by the CDC. The infection control measures applied included decreasing patient load through downsizing emergency department acceptance, maintaining low elective services, limiting inpatient admissions, and encouraging discharge. Early detection and quarantining of any suspected cases took place through extensive contact tracing, properly triaging all patients upon admission, consistent monitoring of inpatients and HCWs for any emerging acute respiratory illness, allocation of more single rooms inside the facility and staff dormitory, and extending the services of virology laboratory to get timely results. Further measures consisted of extensive education on infection control practices, monitoring healthcare worker adherence, reassuring the public by maintaining transparency of published reports, and launching a hotline to respond to HCW concerns. Moreover, travel restrictions applied to any person with a history of exposure to a confirmed MERS-CoV case during the 2-week monitoring period. Results: Overall, 44 cases of MERS-CoV infection were reported from 3 simultaneous clusters during the 2017 Riyadh outbreak, including 11 fatal cases. Among all of the cases, 29 cases were reported at King Saud Medical City. The outbreak at KSMC required 30 days to be controlled. Conclusions: High vigilance for early detection is a key control measure. To be more sensitive, point-of-care MERS-CoV testing is required because clinical suspicion is challenging in patients presenting with acute renal failure.Funding: NoneDisclosures: None

Introduction The high failure rate of clinical trials in traumatic brain injury (TBI) may be attributable, in part, to the use of untested or insensitive measurement instruments. Of more than 1,000 clinical outcome assessment measures (COAs) for TBI, few have been systematically vetted to determine their performance within specific “contexts of use (COU).” As described in guidance issued by the U.S. Food and Drug Administration (FDA), the COU specifies the population of interest and the purpose for which the COA will be employed. COAs are commonly used for screening, diagnostic categorization, outcome prediction, and establishing treatment effectiveness. COA selection typically relies on expert consensus; there is no established methodology to match the appropriateness of a particular COA to a specific COU. We developed and pilot-tested the Evidence-Based Clinical Outcome assessment Platform (EB-COP) to systematically and transparently evaluate the suitability of TBI COAs for specific purposes. Methods and findings Following a review of existing literature and published guidelines on psychometric standards for COAs, we developed a 6-step, semi-automated, evidence-based assessment platform to grade COA performance for six specific purposes: diagnosis, symptom detection, prognosis, natural history, subgroup stratification and treatment effectiveness. Mandatory quality indicators (QIs) were identified for each purpose using a modified Delphi consensus-building process. The EB-COP framework was incorporated into a Qualtrics software platform and pilot-tested on the Glasgow Outcome Scale—Extended (GOSE), the most widely-used COA in TBI clinical studies. Conclusion The EB-COP provides a systematic methodology for conducting more precise, evidence-based assessment of COAs by evaluating performance within specific COUs. The EB-COP platform was shown to be feasible when applied to a TBI COA frequently used to detect treatment effects and can be modified to address other populations and COUs. Additional testing and validation of the EB-COP are warranted.

Cloud computing technology has succeeded in attracting the interest of both academics and industries because of its ability to provide flexible, cost-effective, and adaptable services in IT solution deployment. The services offered to Cloud Service Subscriber (CSS) are based on the concept of on-demand self-service, scalability, and rapid elasticity, which allows fast deployment of IT solutions, whilst leads to possible misconfiguration, un-patched system, etc. which, allows security threats to compromise the cloud services operations. From the viewpoint of Cloud Service Provider (CSP), incidents such as data loss and information breach, will tarnish their reputations, whilst allow them to conserve the issues internally, in which there is no transparency between CSP and CSS. In the aspects of information security, CSP is encouraged to practice cybersecurity in their cloud services by adopting ISO/IEC27017:2015 inclusive of all additional security controls as mandatory requirements. This study was conducted to identify factors that are influencing the CSP readiness level in the cybersecurity implementation of their cloud services by leveraging the developed pre-assessment model to determine the level of cloud security readiness. Approached the study is based on the combination of qualitative and quantitative assessment method in validating the proposed model through interview and prototype testing. The findings of this study had shown that factors that influence the CSP level of cloud security readiness are based on these domains; technology, organisation, policy, stakeholders, culture, knowledge, and environment. The contribution of the study as a Pre-Assessment Model for CSP which is suitable to be used as a guideline to provide a safer cloud computing environment.

321 Background: Standardized structured reporting (SSR) improves quality of diagnostic reporting for cancer patients, resulting in improved interdisciplinary communication in multidisciplinary-team meetings (MTMs) and subsequently better health outcomes and patient safety. In addition, SSR is important to secondary users including (tumor) registry organizations. Nevertheless, SSR-template usage, for example in pathology, varies widely among oncology related medical disciplines. Because of the advantages during MTMs, multidisciplinary-team (MDT) members could play an important role in encouraging and supporting pathologists to use SSR-templates. Therefore, the objective is to identify both barriers and facilitators for SSR-implementation from a MDT-member perspective. Methods: We used a mixed method design. Four focus group interviews with MDT-members, operating in the field of urological, gynecological or gastrointestinal oncology were performed, to identify barriers and facilitators in SSR in relation to the MTMs. Findings were classified into the domains of Flottorp et al. (2013). We used a web-based survey among Dutch MDT-members to quantify the findings. Results: Twenty-three MDT-members of nine medical disciplines participated in the focus group interviews. The survey yielded 211 responses. Main barriers of SSR among MDT-members were lack of information in the standardized structured report, particularly lack of information to retrieve doubts of the pathologist (56%, n = 211); lack of nuances (39%, n = 184); and lack of transparency on development of SSR-templates (50%, n = 211). Pathologists (59%, n = 54) also mentioned the numerous clicking when using SSR-templates as a barrier. Main facilitator was to expand the recommendation of SSR-usage in national guidelines (81%, n = 174). Conclusions: Although the use of SSR by multiple disciplines has benefits, as diagnostic reports are more complete, this study shows important barriers that have to be dealt with in the implementation process of SSR. The next step is to use the barriers for developing and testing implementation tools to encourage SSR-implementation.

AimsViolent or aggressive incidents can be relatively common in community settings, and perhaps more difficult to manage than at inpatient wards due to the relative isolation and peripatetic delivery model, which can put staff at higher risk during incidents. Carshalton and Wallington Recovery Support team was identified as an outlier in the Trust and was invited to partake in a Safety Collaborative across South London Partnership.Stakeholders agreed on the aim of reducing incidents by 20% over 1 year by the end of 2020.MethodData about incidents were analysed and staff surveys conducted to evaluate violent events. Patient discharge was highlighted as a particular time of increased aggression. Involvement of patients and carers through patient focus groups and co-production was essential to elicit areas of improvement. These included staff confidence and awareness of existing guidelines. Additional secondary drivers were communication with patients, care pathway development, discharge process and multidisciplinary approach, which each had associated change ideas.The team identified change ideas that have been tested over one year using the Quality Improvement methodology of small-scale testing and PDSA. Example ideas tested include multidisciplinary Risk meetings, Safety huddle tool, Staff Safety training, co-produced Welcome and Discharge Packs with informed care pathways.ResultThere has been a 30% reduction in incidents by December 2020 across a total of 280 patients. Surveys have shown an increase in staff confidence and safety protocol awareness from 40% to 70% by October 2020. 100% of patients in focus groups found the Welcome and Discharge Packs helpful.ConclusionA structured improvement approach focused on staff safety and minimisation of known and potential contributing factors can lead to a reduction in incidents. Safety huddles and risk meetings allow a formal multidisciplinary approach to management of violence and aggression. Staff feel more reassured about safety policies in the trust, with better communication between senior management and colleagues to highlight risk and provide support. A culture of open discussion and transparency was implemented through provision of Welcome Packs including Care and Discharge Pathways details at point of entry to the service. Support was provided to patients with Discharge Packs including information about community services. This enabled a meaningful support model at the end of their recovery journey and an improved discharge process.The team is now working with additional teams and administrative and clerical staff to improve safety. We hope to replicate this approach in our Trust.

AbstractTwo professional societies recently published opinions on the clinical management of “mosaic” results from preimplantation genetic testing for aneuploidy (PGT-A) in human blastocyst-stage embryos in associations with in vitro fertilization (IVF). We here point out three principal shortcomings: (i) Though a most recent societal opinion states that it should not be understood as an endorsement of the use of PGT-A, any discussion of how PGT-A should be clinically interpreted for all practical purposes does offer such an endorsement. (ii) The same guideline derived much of its opinion from a preceding guidance in favor of utilization of PGT-A that did not follow even minimal professional requirements for establishment of practice guidelines. (iii) Published guidelines on so-called “mosaic” embryos from both societies contradict basic biological characteristics of human preimplantation-stage embryos. They, furthermore, are clinically unvalidated and interpret results of a test, increasingly seen as harmful to IVF outcomes for many infertile women. Qualified professional organizations, therefore, should finally offer transparent guidelines about the utilization of PGT-A in association with IVF in general.

Competition between Higher Education Institutions is increasing at an alarming rate, while changes of the surrounding environment and demands of labour market are frequent and substantial. Universities must meet the requirements of both the national and European legislation environment. The Bologna Declaration aims at providing guidelines and solutions for these problems and challenges of European Higher Education. One of its main goals is the introduction of a common framework of transparent and comparable degrees that ensures the recognition of knowledge and qualifications of citizens all across the European Union. This paper will discuss a knowledge management approach that highlights the importance of such knowledge representation tools as ontologies. The discussed ontology-based model supports the creation of transparent curricula content (Educational Ontology) and the promotion of reliable knowledge testing (Adaptive Knowledge Testing System).

Pharmacogenomic (PGx) testing has emerged as an effective strategy for informing drug selection and dosing. This has led to an increase in the use of PGx testing in the clinic and has catalyzed the emergence of a burgeoning commercial PGx testing industry. However, not all PGx tests are equivalent in their approach to translating testing results into prescribing recommendations, due to an absence of regulatory standards. As such, those generating and using PGx data require tools for ensuring the prescribing recommendations they are provided align with current peer-reviewed PGx-based prescribing guidelines developed by expert groups or approved product labels. Herein, we present Sequence2Script (sequence2script.com), a simple, free, and transparent web-based tool to assist in the efficient translation of PGx testing results into evidence-based prescribing recommendations. The tool was designed with a wide-range of user groups (e.g., healthcare providers, laboratory staff, researchers) in mind. The tool supports 97 gene-drug pairs with evidence-based prescribing guidelines, allows users to adjust recommendations for concomitant inhibitors and inducers, and generates a clinical report summarizing the patient’s genotype, inferred phenotype, phenoconverted phenotype (if applicable), and corresponding prescribing recommendations. In this paper, we describe each of the tool’s features, provide use case examples, and discuss limitations of and future development plans for the tool. Although we recognize that Sequecnce2Script may not meet the needs of every user, the hope is that this novel tool will facilitate more standardized use of PGx testing results and reduce barriers to implementing these results into practice.

Neurological hazard assessment of industrial and pesticidal chemicals demands a substantial amount of time and resources. Caenorhabditis elegans is an established model organism in developmental biology and neuroscience. It presents an ideal test system with relatively fewer neurons (302 in hermaphrodites) versus higher-order species, a transparent body, short lifespan, making it easier to perform neurotoxic assessment in a time and cost-effective manner. Yet, no regulatory testing guidelines have been developed for C. elegans in the field of developmental and adult neurotoxicity. Here, we describe a set of morphological and behavioral assessment protocols to examine neurotoxicity in C. elegans with relevance to cholinergic and dopaminergic systems. We discuss the homology of human genes and associated proteins in these two signaling pathways and evaluate the morphological and behavioral endpoints of C. elegans in the context of published adverse outcome pathways of neurodegenerative diseases. We conclude that C. elegans neurotoxicity testing will not only be instrumental to eliminating mammalian testing in neurological hazard assessment but also lead to new knowledge and mechanistic validation in the adverse outcome pathway framework.

The European Commission published a new Communication on better regulation on 29 April 2021, with the aim of improving the European Union’s (EU) policymaking process. By updating the better regulation agenda to mainstream sustainable development goals and the digital and green transition and by ensuring more foresight-based policymaking, this Communication shows that the Commission is moving in the right direction. Several proposals also have great potential to simplify the better regulation process and make it more transparent. By contrast, the envisaged simplification of the public consultation process may jeopardise its effectiveness and should be carefully reconsidered. In addition, a more cautious, stepwise approach to introducing, testing and adjusting the new EU one-in, one-out system is certainly needed. This article aims to identify and assess the key changes proposed by the new Communication and to share ideas for the preparation of the new Better Regulation Guidelines and Toolbox, which are expected to translate the Communication into practice.

AbstractVariants of uncertain significance represent a massive challenge to medical genetics. Multiplexed functional assays, in which the functional effects of thousands of genomic variants are assessed simultaneously, are increasingly generating data that can be used as additional evidence for or against variant pathogenicity. Such assays have the potential to resolve variants of uncertain significance, thereby increasing the clinical utility of genomic testing. Existing standards from the American College of Medical Genetics and Genomics (ACMG)/Association for Molecular Pathology (AMP) and new guidelines from the Clinical Genome Resource (ClinGen) establish the role of functional data in variant interpretation, but do not address the specific challenges or advantages of using functional data derived from multiplexed assays. Here, we build on these existing guidelines to provide recommendations to experimentalists for the production and reporting of multiplexed functional data and to clinicians for the evaluation and use of such data. By following these recommendations, experimentalists can produce transparent, complete, and well-validated datasets that are primed for clinical uptake. Our recommendations to clinicians and diagnostic labs on how to evaluate the quality of multiplexed functional datasets, and how different datasets could be incorporated into the ACMG/AMP variant-interpretation framework, will hopefully clarify whether and how such data should be used. The recommendations that we provide are designed to enhance the quality and utility of multiplexed functional data, and to promote their judicious use.

A Nutrition Society member-led meeting was held online on 18th January 2021 to discuss the role of observational studies in developing public health policy and dietary guidelines. In addition, participants debated media reporting of observational studies and the implications for public perception and trust in science. Speakers outlined the benefits of observational studies and how they fit within the suite of research tools available for estimating dietary intakes and determining their impact on health and disease risk. However, there are clear limitations, such as conscious and unconscious bias, measurement error, confounding and representativeness of populations. Researchers can overcome some of these issues with careful design, awareness of inter-individual variation, open and transparent reporting of findings, and hypothesis-driven statistical analysis to avoid multiple testing errors. Although there is evidence that data provided by nutritional epidemiology can be misleading, strong and thoughtful methodology including pre-registration, risk of bias assessment, awareness of confounders, and evidence grading can minimise potential bias, particularly when conducting systematic reviews. Translation of relative risk into population health impact is important and feeds into the need for responsible lay communication of results via mass media, especially regarding assumptions about cause and effect. Although use of mass media can bring benefits to academia, responsible dissemination is essential and starts with the press release. In conclusion, nutritional epidemiology is an important tool for exploring the risk/benefits of dietary patterns and contributing to health improvement via dietary guidelines, evidence-based policy and responsible lay communication provided its limitations are fully understood.

BackgroundThe statistics of healthcare worker (HCW) COVID-19 infections do not convey the lived experience of HCWs during the pandemic. This study explores the working conditions and issues faced by Australian HCWs.MethodsQualitative analysis of free-text responses from Australian HCWs from 3 August to 26 October 2020 from an open letter calling for better respiratory protection for HCWs, transparent reporting of HCW COVID-19 infections and diversity in national infection control policy development. The open letter was sent to an email list of 23 000 HCWs from a previous campaign and promoted on social media.ResultsAmong 3587 HCWs who signed the open letter during the study period, 569 free-text responses were analysed. Doctors and nurses accounted for 58% and 33% of respondents, respectively. Most respondents came from Victoria (48%), New South Wales (20%), Queensland (12%) or Western Australia (11%). Dominant themes included concerns about: work health and safety standards; guidelines on respiratory protection including the omission of fit-testing of P2/N95 respirators; deficiencies in the availability, quality, appropriateness and training of personal protective equipment; and a command-and-control culture that enabled bullying in response to concerns about safety that culminated a loss of trust in leadership, self-reported COVID-19 infections in some respondents and moral injury.ConclusionDeficiencies in work health and safety, respiratory protection, personal protective equipment and workplace culture have resulted in a loss of psychological and physical safety at work associated with an occupational moral injury. The challenge for healthcare leaders is to repair trust by addressing HCW concerns and fast track solutions in collaboration with them.

Purpose: Menisci transfer axial loads, while increasing the load-bearing tibiofemoral contact area and decreasing tibiofemoral contact pressure (CP). Numerous clinical and experimental studies agree that an increased CP is one predominant indicator for post-traumatic osteoarthritis (PTOA) of the knee joint. However, due to the immense variability in experimental test setups and wide range of treatment possibilities in meniscus surgery, it is difficult to objectively assess their impact on the CP determination, which is clearly crucial for knee joint health. Therefore, the aim of this systematic review is to investigate the influence of different meniscal injuries and their associated surgical treatments on the CP. Secondly, the influence of different test setups on CP measurements is assessed. On the basis of these results, we established the basis for recommendations for future investigations with the aim to determine CPs under different meniscal states.Methods: This review was conducted in accordance with the PRISMA guidelines. Studies were identified through a systematic literature search in Cochrane, PubMed and Web of Science databases. Literature was searched through pre-defined keywords and medical subject headings.Results: This review indicates a significant increase of up to 235% in peak CP when comparing healthy joints and intact menisci with impaired knee joints, injured or resected menisci. In addition, different test setups were indicated to have major influences on CP: The variety of test setups ranged from standard material testing machines, including customized setups via horizontal and vertical knee joint simulators, through to robotic systems. Differences in applied axial knee joint loads ranged from 0 N up to 2,700 N and resulted unsurprisingly in significantly different peak CPs of between 0.1 and 12.06 MPa.Conclusion: It was shown that untreated traumatic meniscal tears result in an increased CP. Surgical repair intervention were able to restore the CP comparable to the healthy, native condition. Test setup differences and particularly axial joint loading variability also led to major CP differences. In conclusion, when focusing on CP measurements in the knee joint, transparent and traceable in vitro testing conditions are essential to allow researchers to make a direct comparison between future biomechanical investigations.

In January 2005 Dr. Mean Chhi Vun, director of the Cambodian National Center for HIV/AIDS, Dermatology and STDs (NCHADS), needed to decide how to control the spread of HIV/AIDS and save the lives of thousands of Cambodians who were dying from it each year. In the seven years since Dr. Vun had been appointed director, NCHADS had built an organization that was transparent and efficient, had implemented a nationwide 100 percent Condom Use Program, had established a system that allowed individuals to voluntarily seek confidential counseling and testing, and had instituted a set of guidelines and procedures for staff at health facilities to refer HIV-positive patients to treatment clinics and link them with NGOs providing financial and psychosocial support. Now, however, Dr. Vun faced decisions about three initiatives that were critical to expanding care and treatment programs in his country. First, he needed to decide how to quickly and cost-effectively improve the national HIV/AIDS laboratory support infrastructure. Second, Dr. Vun needed to improve logistics and supply management in order to get the best prices and ensure patients had access to life-saving medicines. Finally, he needed to figure out how to provide sustainable care and treatment to the thousands of Cambodian children living with HIV/AIDS.Create innovative solutions for large-scale, socially relevant challenges. Understand how to start, scale, and lead cross-sector public health initiatives, or any initiative requiring behavior change by a range of players on a large scale over the long term. Discover and implement operating models that balance the needs of for-profit, non-profit, and government organizations. More effectively manage situations where required resources are not under one's direct control.

Background: Computerized decision support systems (CDSS) provide new opportunities for automating antimicrobial stewardship (AMS) interventions and integrating them in routine healthcare. CDSS are recommended as part of AMS programs by international guidelines but few have been implemented so far. In the context of the publicly funded COMPuterized Antibiotic Stewardship Study (COMPASS), we developed and implemented two CDSSs for antimicrobial prescriptions integrated into the in-house electronic health records of two public hospitals in Switzerland. Developing and implementing such systems was a unique opportunity for learning during which we faced several challenges. In this narrative review we describe key lessons learned.Recommendations: (1) During the initial planning and development stage, start by drafting the CDSS as an algorithm and use a standardized format to communicate clearly the desired functionalities of the tool to all stakeholders. (2) Set up a multidisciplinary team bringing together Information Technologies (IT) specialists with development expertise, clinicians familiar with “real-life” processes in the wards and if possible, involve collaborators having knowledge in both areas. (3) When designing the CDSS, make the underlying decision-making process transparent for physicians and start simple and make sure to find the right balance between force and persuasion to ensure adoption by end-users. (4) Correctly assess the clinical and economic impact of your tool, therefore try to use standardized terminologies and limit the use of free text for analysis purpose. (5) At the implementation stage, plan usability testing early, develop an appropriate training plan suitable to end users' skills and time-constraints and think ahead of additional challenges related to the study design that may occur (such as a cluster randomized trial). Stay also tuned to react quickly during the intervention phase. (6) Finally, during the assessment stage plan ahead maintenance, adaptation and related financial challenges and stay connected with institutional partners to leverage potential synergies with other informatics projects.

Background: No information is available on the antimicrobial sensitivity pattern and guidelines for oral antibiotic therapy for Yemeni patients for those with localized aggressive periodontitis (LAP) due to Porphyromonas gingivalis, a condition that often requires complementary antibiotic treatment. Aim: The primary aim of the current study was to examine the antibiotic patterns and the potential relationship between P. gingivalis biofilm formation and the incidence of antibiotic resistance of clinical isolates on a group of antibiotics commonly used in oral/systemic therapy. Subjects and Methods: The study included 30 clinically diagnosed patients, and 30 strains of P. gingivalis were isolated from them. Microbial sampling, isolation, and identification of bacteria were performed using culture methods appropriate to anaerobic species. Biofilm production was evaluated by the phenotypic method, that is, tissue culture methods (TCPM). Also; each isolate was tested against 12 antibiotics using the disc diffusion method. Results: After isolated P. gingivalis were subjected to biofilm detection by TCP method, 7 (23.3%) showed high, 6 (20%) moderate, while 17 (56.7%) showed non/weak biofilm-forming ability. P. gingivalis biofilms showed a higher resistance rate than forming non/weak biofilms e.g amoxicillin (92.3% vs 64.7%, p = 0.08), azithromycin (58.8% vs 11.7, p =0.003), metronidazole (76.9% vs 29.4%, p = 0.08), 0.01) and clindamycin (84.6% vs 47.1, p = 0.03). Conclusion: It was found that the drug-resistant factor in P. gingivalis isolates is associated with the formation of P. gingivalis biofilm. Even though the current results show a high sensitivity result for P. gingivalis strains, some resistance has been observed. Antibiotic resistance patterns can modify over the years, make susceptibility testing essential and to promote careful choice of preliminary antibiotic treatment, the same as an adjuvant to endodontic therapy. Peer Review History: Received: 9 July 2021; Revised: 12 August; Accepted: 6 September, Available online: 15 September 2021 Academic Editor: Dr. Ali Abdullah Al-yahawi, Al-Razi university, Department of Pharmacy, Yemen, alyahawipharm@yahoo.com UJPR follows the most transparent and toughest ‘Advanced OPEN peer review’ system. The identity of the authors and, reviewers will be known to each other. This transparent process will help to eradicate any possible malicious/purposeful interference by any person (publishing staff, reviewer, editor, author, etc) during peer review. As a result of this unique system, all reviewers will get their due recognition and respect, once their names are published in the papers. We expect that, by publishing peer review reports with published papers, will be helpful to many authors for drafting their article according to the specifications. Auhors will remove any error of their article and they will improve their article(s) according to the previous reports displayed with published article(s). The main purpose of it is ‘to improve the quality of a candidate manuscript’. Our reviewers check the ‘strength and weakness of a manuscript honestly’. There will increase in the perfection, and transparency. Received file: Reviewer's Comments: Average Peer review marks at initial stage: 6.0/10 Average Peer review marks at publication stage: 7.0/10 Reviewers: Dr. Rawaa Souhil Al-Kayali, Aleppo University, Syria, rawah67@hotmail.com Dr. Wadhah Hassan Ali Edrees, Hajja University, Yemen, edress2020@gmail.com Rola Jadallah, Arab American University, Palestine, rola@aauj.edu Similar Articles: RISK FACTORS OF PERIODONTAL DISEASES AMONG YEMENI YOUNG DENTAL PATIENTS

Background: Home care workers help older individuals and those with disabilities with a variety of functional tasks. Despite their core role providing essential care to vulnerable populations, home care workers are often an invisible sector of the healthcare workforce. The transmission of COVID-19 and the nature of home care work raise several questions about the overall safety of these workers during the pandemic. Objective: To examine the experiences of home care workers during COVID-19, particularly their access to information about infection status, to testing, and to personal protective equipment (PPE); their understanding of guidelines; and trade-offs associated with protecting workers’ safety. Methods: A mixed methods study including qualitative analysis of guided discussion questions and quantitative analysis of multiple-choice survey questions was conducted. Eleven virtual focus groups in October and November 2020 involved 83 home care workers who care for clients/consumers in Massachusetts. Thirty-nine participants worked as personal care attendants (PCAs) employed directly by a consumer and 44 participants worked for an agency. Ninety percent self-identified as female and 54% had worked in home care for more than five years. Qualitative data was analyzed using thematic analysis, with identification of major and minor themes. Likert scale survey question data on perceptions of COVID-19 exposure, access to resources to prevent transmission, and perceptions of safety at work were dichotomized into agree or disagree. Results: PCAs and agency-employed home care workers were regularly faced with trade-offs between meeting client/consumer needs and protecting themselves from COVID-19 exposure. Twenty-five percent of participants reported serving a client/consumer who had COVID-19, 75% reported worrying about getting COVID-19 at work, and 29% reported thinking about stopping their work in home care. Despite a low pay structure, participants reported opting to risk exposure rather than to leave their clients/consumers without essential care. However, workers often lacked the resources (e.g., PPE, testing) to feel truly protected. This scarcity of resources combined with insufficient guidance and policies specific to home care settings led many workers to informally collaborate with clients/consumers to assess exposure risks and agree upon safety protocols. Focus group participants expressed uncertainty as to whether workers were truly empowered to ask for changes if conditions seemed unsafe. The burden of determining safety protocols was felt more strongly by PCAs who operate more independently than agency-employed workers who have supervisors to consult. Conclusions: Home care workers expressed deep commitment to continuing to care for their clients/consumers during COVID-19, but often had to operate with insufficient resources and under conditions that made their work environments feel unsafe. Their ability to identify exposure risks and make decisions on how to protect themselves often hinged on a transparent and trusting relationship with their clients/consumers. These relationships were particularly important for PCAs who did not have access to safety guidance from a home care agency.

Abstract Background Th EQUATOR Network improves the quality and transparency in health research, primarily by promoting awareness and use of reporting guidelines. In 2018, the UK EQUATOR Centre launched GoodReports.org, a website that helps authors find and use reporting guidelines. This paper describes the tool’s development so far. We describe user experience and behaviour of using GoodReports.org both inside and outside a journal manuscript submission process. We intend to use our findings to inform future development and testing of the tool. Methods We conducted a survey to collect data on user experience of the GoodReports website. We cross-checked a random sample of 100 manuscripts submitted to a partner journal to describe the level of agreement between the tool’s checklist recommendation and what we would have recommended. We compared the proportion of authors submitting a completed reporting checklist alongside their manuscripts between groups exposed or not exposed to the GoodReports tool. We also conducted a study comparing completeness of reporting of manuscript text before an author received a reporting guideline recommendation from GoodReports.org with the completeness of the text subsequently submitted to a partner journal. Results Seventy percent (423/599) of survey respondents rated GoodReports 8 or more out of 10 for usefulness, and 74% (198/267) said they had made changes to their manuscript after using the website. We agreed with the GoodReports reporting guideline recommendation in 84% (72/86) of cases. Of authors who completed the guideline finder questionnaire, 14% (10/69) failed to submit a completed checklist compared to 30% (41/136) who did not use the tool. Of the 69 authors who received a GoodReports reporting guideline recommendation, 20 manuscript pairs could be reviewed before and after use of GoodReports. Five included more information in their methods section after exposure to GoodReports. On average, authors reported 57% of necessary reporting items before completing a checklist on GoodReports.org and 60% after. Conclusion The data suggest that reporting guidance is needed early in the writing process, not at submission stage. We are developing GoodReports by adding more reporting guidelines and by creating editable article templates. We will test whether GoodReports users write more complete study reports in a randomised trial targeting researchers starting to write health research articles.

Abstract In personalized medicine, predictive biomarker testing is the basis for an appropriate choice of therapy for patients with cancer. An important tool for laboratories to ensure accurate results is participation in external quality assurance (EQA) programs. Several providers offer predictive EQA programs for different cancer types, test methods, and sample types. In 2013, a guideline was published on the requirements for organizing high-quality EQA programs in molecular pathology. Now, after six years, steps were taken to further harmonize these EQA programs as an initiative by IQNPath ABSL, an umbrella organization founded by various EQA providers. This revision is based on current knowledge, adds recommendations for programs developed for predictive biomarkers by in situ methodologies (immunohistochemistry and in situ hybridization), and emphasized transparency and an evidence-based approach. In addition, this updated version also has the aim to give an overview of current practices from various EQA providers.

This paper explores the ethical dimension of the opportunity to offer improved electronic patient-reported outcome (ePRO) systems addressing personal needs of pediatric cancer patients, their parents and caregivers, with regard to technological advance of digital health. This opportunity has been explored in the MyPal research project, which aims to assess a patient-centered service for palliative care relying on the adaptation and extension of digital health tools and concepts available from previous projects. Development and implementation of ePROs need to take place in a safe, secure and responsible manner, preventing any possible harm and safeguarding the integrity of humans. To that end, although the final results will be published at the end of the project, this paper aims to increase awareness of the ethical ramifications we had to address in the design and testing of new technologies and to show the essentiality of protection and promotion of privacy, safety and ethical standards. We have thus reached a final design complying with the following principles: (a) respect for the autonomy of participants, especially children, (b) data protection and transparency, (c) fairness and non-discrimination, (d) individual wellbeing of participants in relation to their physical and psychological health status and e) accessibility and acceptability of digital health technologies for better user-engagement. These principles are adapted from the Ethics Guidelines for a trustworthy Artificial Intelligence (AI) which provide the framework for similar interventions to be lawful, complying with all applicable laws and regulations, ethical, ensuring compliance to ethical principles and values and robust, both from a technical and social perspective.

Abstract Study question Is it possible to find viral Sars-Cov–2 RNA in FF of women undergoing treatment during Covid–19 pandemic that may compromise gamete and embryo safety? Summary answer No viral RNA was detected in tested FF of women undergoing IVF in compliance with recommendations. This was reassuring and supported good medical practice. What is known already Risks due to SARS-CoV–2 during IVF remain difficult to assess despite the screening recommended by French health authorities based on a symptom questionnaire of the couple (systematic testing by RT-PCR for the virus before egg retrieval (ER) is not mandatory). In this context, this is a real challenge for IVF laboratory to guarantee procedure, patients, gametes and embryos safety. Most studies have reported the absence of virus in sperm. No data are available for FF and only one study looked for the presence of the virus in oocytes of Covid-affected patients (Barragan M et al, 2020). Study design, size, duration Between June 17 and September 24, 2020, FF of consenting women were prospectively collected and symptom questionnaire recorded. During this period, women undergoing IVF in our center did not benefit from systematic PCR testing for the virus within 72 hours prior to ER through our health authorities’ recommendations. All collected FF were retrospectively tested to research viral RNA by RT-PCR and patients were recalled to answer an epidemiological follow-up questionnaire. Participants/materials, setting, methods For all couples, symptom questionnaires were prospectively recorded and verified at each step of IVF procedure. For all consenting women, a sample of 1 ml of FF was collected the day of ER and stored at –80 °C. After thawing, a Sars-Cov2 multiplex RT-PCR using CFX96 (Biorad*) was performed, after RNA extraction using Nimbus (Seegene*). A comprehensive epidemiological evaluation was made afterwards by phone interview and data were recorded and analyzed. Main results and the role of chance A total of 183 women was included out of the 214 treated during this period (85.5%). Retrospective epidemiological evaluation showed that 8 patients contracted Covid more than 2 months before the ER, 6 more than 2 months after and only one patient 1 month after ER (diagnosis based on pathognomonic signs as agueusia and anosmia or/and positive PCR ). We observed a prevalence of symptomatic Covid forms in our IVF population of 8.2% during a 6-month period surrounding their IVF cycle. Moreover, until the introduction of systematic testing by RT-PCR for the virus before ER since the end of September 2020, 3 patients have been cancelled out of the 403 planned for positive PCR despite a negative questionnaire, which represents a prevalence of asymptomatic forms on the day of the ER at 0.7%. All the 183 FF tested did not reveal any viral RNA detection, which was reassuring concerning our medical practice and patient compliance and transparency. The absence of detected viral RNA may be due to several reasons: 1) women were not infected the day of ER 2) women had an asymptomatic form of the disease with low viral load 3) FF is not a virus reservoir. Limitations, reasons for caution Not all patients were included (85.5%). Post-diagnosis stays uncertain because PCR tests at the beginning of the epidemic were not mandatory and hardly available. Wider implications of the findings: The absence of viral RNA in FF of women only screened through a symptom questionnaire is reassuring concerning the safety of IVF during Covid pandemic. Trial registration number Not applicable

Background: Standardized structured reporting (SSR) improves quality of diagnostic cancer reporting and interdisciplinary communication in multidisciplinary team (MDT) meetings, resulting in more adequate treatment decisions and better health outcomes. However, use of SSR varies widely among pathologists, but might be encouraged by MDT members (MDTMs). Our objectives were to identify barriers and facilitators (influencing factors) for SSR implementation in oncologic pathology from the perspective of MDTMs and their determinants. Methods: In a multimethod design, we identified influencing factors for SSR implementation related to MDT meetings, using 5 domains: (1) innovation factors, (2) individual professional factors, (3) social setting factors, (4) organizational factors, and (5) political and legal factors. Four focus groups with MDTMs in urologic, gynecologic, and gastroenterologic oncology were conducted. We used an eSurvey among MDTMs to quantify the qualitative findings and to analyze determinants affecting these influencing factors. Results: Twenty-three MDTMs practicing in 9 oncology-related disciplines participated in the focus groups and yielded 28 barriers and 28 facilitators in all domains. The eSurvey yielded 211 responses. Main barriers related to lack of readability of SSR: difficulties with capturing nuances (66%) and formulation of the conclusion (43%); lack of transparency in the development (50%) and feedback processes of SSR templates (38%); and lack of information exchange about SSR between pathologists and other MDTMs (45%). Main facilitators were encouragement of pathologists’ SSR use by MDTMs (90%) and expanding the recommendation of SSR use in national guidelines (80%). Oncology-related medical discipline and MDT type were the most relevant determinants for SSR implementation barriers. Conclusions: Although SSR makes diagnostic reports more complete, this study shows important barriers in implementing SSR in oncologic pathology. The next step is to use these factors for developing and testing implementation tools to improve SSR implementation.

Translational Medicine and Exercise Prescription (TMEP): Advancing the Era of Exercise Medicine Sulin Cheng1,2,3,4, Moritz Schumann()2,4 and Wilhelm Bloch4 1Exercise, Health and Technology Center, Department of Physical Education, Shanghai Jiao Tong University, Shanghai, China 2Exercise Translational Medicine Center, Shanghai Center for Systems Biomedicine, Shanghai Jiao Tong University, Shanghai, China 3Faculty of Sport and Health Sciences, University of Jyväskylä, Jyväskylä, Finland 4Department of Molecular and Cellular Sport Medicine, German Sport University, Cologne, Germany © The Authors "Exercise is medicine" has gained popularity worldwide after the American Medical Association and the American College of Sports Medicine co-launched their ground-breaking health initiative in 20071 . This initiative was aimed at improving population health and well-being, mainly by raising the awareness of healthcare providers to regard performing physical activity (PA) as one of the vital signs. Ever since, this concept has spread worldwide and PA has been proposed as an essential part of treatment for chronic diseases2 . In their pioneering work, Pedersen and Saltin provided compelling evidence for the role of exercise as the first- or second-line therapy for at least 26 diseases2 . These findings are further corroborated by meta-epidemiological data, indicating exercise interventions to be as effective as drug interventions, such as during rehabilitation after stroke and for the treatment of heart failure3 . However, the overall effect appears to be strongly correlated with important determinants of the exercise program performed (i.e. dose of training [frequency, volume, intensity], type of exercise and adherence to the training program) and disease-related specifics4 , thus requiring not only clinical expertise but also an in-depth understanding of exercise physiology and biology. In this new journal-Translational Medicine and Exercise Prescription (TMEP), we are aiming to bring together the fields of exercise physiology and biology, sports medicine and the science of physical training and testing to bridge the gap between mechanistic research and clinical practice. The journal covers nine sections, including obesity, diabetes, cancer, cardiovascular diseases, neurological and psychiatric diseases, pulmonary diseases, musculoskeletal diseases, endocrine disorders as well as advanced exercise prescription and health maintenance. In this first issue of TMEP, we are delighted to present seven papers from different areas of translational research performed in humans on specific themes related to the treatment and prevention of chronic diseases. Appropriate selection of primary and secondary endpoints is critical for successfully designing translational studies. In the first paper of this issue, TMEP Section Editor, Jörn Rittweger provides his thoughts on "What Are Good Muscle Endpoints for Translational Studies?". In his important work, he highlights the importance of muscles for our health because of their size, their involvement in energy metabolism and their relevance for locomotion. He further suggests that at least eight different muscle functions are important to health. Well accepted methods exist for three relevant muscular endpoints, namely for power, strength and muscle mass, and these endpoints are utilized in clinical studies. However, such validated methods lack a number of additional muscle functions that are not yet fully scientifically explored. This applies foremost to not only the metabolic functions of muscles, but also to their role in storage and dissipation of mechanical energy. His work concludes by emphasizing how physiological knowledge can be an important base for the guidance of clinical diagnostics. Following this important message, the group of TMEP Section Editor Pieter de Lange shares their work entitled "Exercise with Energy Restriction as a Means of Losing Body Mass While Preserving Muscle Quality and Ameliorating Comorbidities: Towards A Therapy for Obesity?". Obesity and related comorbidities have reached pandemic proportions worldwide, particularly during the past decade. Therefore, finding effective intervention strategies not only requires scientific focus but these strategies are also of public interest. Based on both human and animal studies, this narrative review summarizes the effects of dietary and exercise-based programs on loss of different body mass components. Furthermore, both the gain and lack of loss of lean mass in view of muscle quality maintenance are discussed and data related to the mechanisms underlying the conservation of functional muscle mass provided. They also provide evidence of the interaction between energy restriction by diet and exercise-induced metabolic demands at the molecular level. This insight into the mechanisms underlines the relevance of translational considerations for personalized exercise prescription. Obesity and an unhealthy lifestyle are also known to be among the risk factors for type 2 diabetes (T2DM). The research group of TMEP Section Editor Thomas Yates highlights research opportunities and challenges for combining exercise and medical therapies by means of a narrative review entitled "Exercise, Pharmaceutical Therapies and Type 2 Diabetes: Looking beyond Glycemic Control to Whole Body Health and Function". The authors provide evidence on newer generations of glucose-lowering therapies that also induce concomitant weight loss, particularly on glucagon-like peptide-1 receptor agonists (GLP-1RAs) and sodium-glucose cotransporter 2 inhibitors (SGLT2is). Based on current knowledge, they stress the importance of investigating the interaction or synergy between exercise and other glucose-lowering or weight loss therapies, to make exercise a tailored therapy rather than a generic treatment in the management of T2DM. This review, therefore, clearly highlights the need of precise exercise prescription, originating from an in-depth mechanistic understanding of the effects of exercise. Cancer is another important metabolic and chronic inflammatory disease that may also be associated with obesity. TMEP Section Editor Jesper F Christensen and Associate Editor Ciaran M Fairman provide a very interesting viewpoint in their article,"Targeted Exercise Training for Cancer Patients: Moving beyond Generic Exercise Guidelines in Clinical Oncology". This paper aims to update the current knowledge and the clinical rationale for targeted exercise interventions in exercise oncology. Moreover, a framework for systematic guidance of the design and execution of targeted exercise interventions in oncology is presented. The authors hope that their framework can encourage further research into targeted exercise interventions in oncology and may also be used as a guideline for the design of future trials to increase quality and impact. The group of TMEP Section Editor Helen Dawes, shares their original data in the context of neurological and psychiatric diseases in the article entitled "Physical Activity and Fatigue in Multiple Sclerosis: Secondary Outcomes from a Double-blinded Randomized Controlled Trial of Cocoa Flavonoid Drinks". In this study, they performed intensive phenotyping of the inter-relationships of the time of day, physical activity levels and fatigue to determine exercise prescription in a group of people with multiple sclerosis (MS) participating in a six-week randomized controlled trial of morning flavonoid intake. It was found that fatigue levels increased during the day and higher levels of fatigue reduced physical activity; yet physical activity itself did not lead to increased fatigue. Additionally, morning cocoa intake reduced daytime fatigue and fatigue related to subsequent physical activity. Therefore, combined prescription of morning exercise and dietary flavonoids may optimize the exercise and physical activity potential in people with MS. This study nicely demonstrates the importance of understanding and considering possible covariants such as nutrition and chronobiology to determine an optimal exercise prescription model. TMEP Section Editor Jonathan Myers and colleague Baruch Vainshelboim present a narrative review on "Resistance Training for Rehabilitation of Patients with Idiopathic Pulmonary Fibrosis". In this paper, the pathophysiology and clinical manifestations of Idiopathic Pulmonary Fibrosis (IPF) are summarized with an emphasis on the numerous health and clinical benefits of resistance training among older adults and patients with this respiratory disease. This article effectively explores the potential mechanisms by which systematic resistance training may help overcome exercise limitations in IPF, providing a therapeutic opportunity for rehabilitation. Furthermore, the authors provide important recommendations for pulmonary rehabilitation programs that are based on resistance training for patients with IPF. With this paper, the authors highlight that disease-adapted exercise prescription requires a pathophysiological understanding to justify the inclusion of specific exercise regimens. In the final paper of this special issue, the research group of Section Editor Anthony C Hackney shares their original data on the "Energy Availability and RED-S Risk Factors in Competitive, Non-elite Male Endurance Athletes". This paper particularly emphasizes the entire spectrum of TMEP, that is more than just the most common types of non-communicable diseases, but also includes chronic conditions that may be for example induced by athletic training. In this study, the authors assessed the associations of energy availability and risk factors of relative energy deficiency in sport (RED-S) in 60 competitive, recreationally trained male endurance athletes. They found that hormonal and bone biomarkers were within normal clinical ranges, even when the energy availability was low. The authors further state that athletes are considered at a high risk for RED-S if their energy availability is low (<30 kcal/kg FFM), which is based primarily upon research in women. However, the included recreationally trained male endurance athletes were below this criterion but displayed no RED-S symptomology. Thus, the authors suggest that the <30 kcal/kg FFM criterion may not be a valid categorization for a high risk of RED-S in non-elite male endurance athletes, highlighting the importance of using other criteria. While the purpose of this first issue is to stimulate further discussion on the topic of translational medicine and exercise prescription from different disciplines, we wish to highlight that these topics are not exhaustive and there are many more questions that must be addressed. With TMEP, we aim to introduce a platform for the transparent dissemination of research findings, where special consideration will be given to novel types of exercise prescriptions, including technology-based intervention approaches as well as mechanism-driven studies with translation to exercise prescription. Moreover, TMEP encourages submissions of "negative findings" and/or possible reports of harmful adverse events (e.g. if trials are terminated prematurely) as long as the quality of the study can be assured (i.e. indicated by relevance/novelty of the question, rigorous methodology, transparency and reproducibility). We strongly encourage submissions from all parts of the world to further improve our understanding on exercise prescription based on mechanistic approaches and by that commence a new era of evidence-based precision exercise medicine.

Background: Choosing Wisely Canada (CWC), an initiative to reduce low-value care, launched in April 2014. However, it remains unclear to what extent physicians are aware of the initiative and specific recommendations. The objective of this study was to assess physician awareness of the CWC campaign and recommendations, in addition to assessment of attitudes and perspectives on low-value medical care.Methods: This study was conducted as a survey of faculty physicians and residents of McMaster University. Electronic surveys were sent to all faculty physicians and residents within specialties with CWC recommendations. Responses were analyzed to determine awareness of CWC recommendations, defined as awareness of ≥3 recommendations targeted to a respondent’s respective specialty.Results: A total of 361 respondents were included in the analysis (response rate = 33%). Eighty-eight percent of respondents were aware of the CWC campaign. Only 30.1% (95% CI 23.5–36.7%) of respondents were able to correctly describe ≥3 of the recommendations targeted to their respective specialty, with a mean of 1.6 (95% CI 1.4–1.9) recommendations correctly identified per respondent. Most recommendations (70.9%) were reported as already being part of a respondents’ practice prior to release of the CWC recommendations. Interpretation: Despite general awareness of the CWC campaign, more than two thirds of physicians cannot describe most recommendations targeted to their own specialty. Nonetheless, many of these physicians report already practicing in compliance with these recommendations. Future studies are required to identify methods to improve communication, to track compliance with current CWC recommendations, and to determine areas of care that would most benefit from additional recommendations. Choosing Wisely Canada (CWC), an initiative to reduce low-value and unnecessary medical care, launched in April 2014.1 Modeled after the Choosing Wisely campaign in the US,2 CWC seeks to engage clinicians and patients in conversation about unnecessary tests and treatments. The campaign centres on “top five” lists developed by medical specialty societies of items within their respective specialties deemed to be of low-value, lacking benefit, or potentially harmful.3 CWC recommendation lists were intended to be physician-led, patient-focused, evidence-based, multi-professional, and transparent,4 with each group formulating their own list using these guiding principles.The Institute of Medicine estimates that approximately 30% of health care in the US adds no value to patient care.5 Additionally, a large majority of physicians have recognized over-testing as an issue, and 72% of those surveyed acknowledge ordering at least one unnecessary test or treatment each week.6 Common reasons cited for doing so included concerns for malpractice, safety, and patient preference.Specific list recommendations have been rolled out by national specialty societies and in local campaigns in hospitals across Canada. Further, Canadian medical schools are beginning to incorporate the campaign into the undergraduate curriculum through the Students and Trainees Advocating for Resource Stewardship campaign, and resource stewardship has been added to the CanMEDS ‘Leader’ competency.7,8 However, early research out of the US suggests that its now 3-year-old campaign has had variable success, with little effect on national physician practice. Analysis of 7 low-value services found only a very modest improvement in practice in two specific Choosing Wisely recommendations.9 Of the remaining five, three demonstrated no change in practice, and two revealed changes contradictory to the recommendation.As the campaign has passed the 3-year mark in Canada, it is not yet known what effect it has had on physician practice. Furthermore, it remains unclear to what extent physicians, including trainees, have been aware of the initiative, and whether they are aware of specific recommendations relevant to their own specialty. The objective of this study was to assess physician awareness of the CWC campaign, both in terms of general awareness and of specialty-specific recommendations, in addition to assessment of attitudes and perspectives on low-value medical care.MethodsDesign and PopulationThe study was conducted as a survey among physician residents and faculty at McMaster University in Hamilton, Ontario. The project was exempted from full review by the Hamilton Integrated Research Ethics Board.The survey was sent to all residents and faculty within specialties that had existing CWC recommendations at the time of survey dissemination. Email lists of residents and faculty physicians were provided to us from individual programs. Emails were initially sent in March 2016, with reminder emails sent out monthly for two subsequent months. The survey remained open from March to June 2016. Respondents were excluded from survey analysis if their primary specialty lacked CWC recommendations, or if they self-reported that less than 10% of their work was devoted to clinical duties.ContentThe survey questions were created to collect data on respondent demographics, awareness of CWC recommendations, and to assess attitudes and perspectives of respondents on low-value medical care. Questions were devised via discussion among content experts, and in conjunction with previously unpublished surveys that assessed similar themes. After initial completion, the survey was pilot tested among ten residents and faculty physicians, and subsequent changes were made to improve on its readability, avoid misinterpretation of specific questions, and improve response options.The primary outcome of the survey was the proportion of respondents with awareness of at least three of the CWC recommendations targeted to their respective specialty. If a respondent answered positively to awareness of the CWC campaign, they were asked to describe up to five of the recommendations in their own words, including for each recommendation the (1) target population, (2) test, procedure, and/or intervention, and (3) clinical context (when applicable). Responses were categorized as correctly aware of the recommendation if they included all of (1), (2), and (3, when applicable). Two independent adjudicators assessed responses; if disagreement occurred following a consensus step, the response was assessed by a third adjudicator.Data AnalysisSurvey data was analyzed using descriptive statistics. Primary outcome data was presented using confidence interval on a proportion.ResultsDemographicsThe survey was sent to 1361 physicians, with 446 individuals (201 faculty physicians, 245 residents) responding to the survey (response rate = 33%). Of these, 85 were excluded for various reasons (47 for incomplete surveys, 26 for primary specialty without CWC recommendations, and 12 for self-reporting less than 10% of their work as devoted to clinical duties). A total of 361 responses, representing 22 specialties, were included in the final analysis (Table 1). The mean age of respondents was 37.6 (SD ±12.0). The largest proportion of responses came from Family Medicine (25%), Internal Medicine (20%), Emergency Medicine (10%), and Anesthesia (8%).Table 1. Demographics of survey respondents Awareness of the Campaign and its RecommendationsA total of 316 respondents (88%) were aware of the CWC campaign (Table 2). Respondents reported awareness via word of mouth (26%), medical publications, (21%), conferences (16%), and hospital communications (10%). Of these, 185 (59%) reported awareness of their own specialty’s recommendations. Only 56 respondents (30.1%, 95% CI 23.5–36.7%) were able to correctly identify ≥3 of these recommendations. Respondents correctly identified an average of 1.6 (95% CI 1.4–1.9) recommendations (1.7, 95% CI 1.3–2.1 vs. 1.5, 95% CI 1.2–1.8, for faculty physicians versus residents, respectively). The frequency of specific recommendations correctly identified by respondents is presented in Table 2.Table 2. Awareness of the Choosing Wisely Canada Campaign Perspectives on Specific CWC RecommendationsRespondents were presented with the specific CWC recommendations targeted to their specialty, and asked to respond to the recommendations’ influence on their practice (Table 3). A total of 2,425 recommendations were presented to the 361 respondents. Respondents noted that the individual recommendations were likely to change their practice in 18.5% of cases. In only 10.6% of cases did the respondent note that the recommendation would not change their practice. The remaining 70.9% of cases stated that the recommendation was already their practice prior to release of the CWC recommendations. Table 3. Perspectives on Specific Choosing Wisely Canada Recommendations Views on Low-Value Medical ServicesRespondent attitudes and perspectives on low-value medical services are presented in Figure 1. A majority of respondents either agreed or strongly agreed that they have a responsibility to decrease use of inappropriate health care services (95%, 95% CI 93–97%), and that many patients would benefit from implementation of recommendations to decrease use of these services (82%, 95% CI 78–86%). Respondents mostly disagreed or strongly disagreed with the notion that patients have sufficient information to make informed decisions about inappropriate use of services (54%, 95% CI 49–59%). Most respondents either agreed or strongly agreed that cost to society is an important factor in decision-making around interventions (65%, 95% CI 60–70%), though many disagreed or strongly disagreed that they were aware of the costs of these tests and/or treatments (30%, 95% CI 25–35%). Figure 1. Views on low-value medical services (n = 347 ) Respondents were additionally asked to rank four barriers to implementing recommendations to decrease use of inappropriate services (Figure 2). Most respondents (38%, 95% CI 33–43%) ranked concern regarding medico-legal risk as the number one barrier, with patient requests for tests and treatments closely following (33%, 95% CI 28–38%). Lack of time to assess whether an individual would or would not benefit from a service was ranked first by 25% (95% CI 20–30%) of respondents. Only 4% (95% CI 2–6%) of respondents ranked payment policies that reward ordering more services as the top barrier. Figure 2. Barriers to implementing recommendations (n = 347). DiscussionAs far as we are aware, this is the first survey to assess physician awareness of the CWC campaign. Our results indicate that while most physicians have a general awareness of the campaign, few are able to describe most of the specific recommendations targeted to their own specialty. Only 30.1% of respondents could appropriately describe three or more recommendations, and over half of respondents were able to describe only one, or couldn’t describe any, of the recommendations. In addition, respondents’ views were largely supportive of reducing low-value medical care, with physicians acknowledging both responsibility and a patient-benefit to reducing use of inappropriate services.Our results suggest, however, several possible barriers to the campaign having an impact on practice. For one, the lack of awareness may indicate that there has been inadequate communication of specific recommendations. Previous work in the United States has found that physicians aware of the Choosing Wisely campaign view it as a legitimate source of guidance, and report that it has empowered them to reduce the use of unnecessary tests and procedures.10 Accordingly, a lack of awareness would likely be a significant impediment in attempts to reduce resource utilization of low-value medical care. However, our findings additionally demonstrate that respondents report practicing in compliance with 70.9% of recommendations prior to release of the CWC campaign.While it is possible that there is a discrepancy between physicians’ reported and actual practice, these findings are in keeping with other studies suggesting that certain recommendations had high rates of baseline adherence prior to publication of the campaign. A study from the United States identified very low baseline rates of preoperative stress testing before low-risk surgeries,11 while another identified infrequent rates of Pap testing among women under 21 years of age and sinusitis imaging for acute mild-to-moderate sinusitis or uncomplicated acute rhinitis.9 These findings were all in accordance with published Choosing Wisely recommendations, suggesting that some recommendations were not targeting high-yield areas of low-value care. However, while a recent Canadian study by Kirkham and colleagues assessing preoperative testing prior to low-risk surgical procedures within Ontario hospitals demonstrated low baseline utilization of certain tests (e.g., echocardiography, stress tests), it did show widely variable utilization of other tests (e.g., electrocardiogram) among institutions.12 This may indicate that further communication of the CWC recommendations may have greater impact within institutions with lower rates of baseline compliance. Additionally, measurements of baseline utilization prior to release of further recommendations may help identify areas of greatest potential impact.Our study additionally demonstrated other areas in which further interventions could potentially impact rates of utilization of low-value care. Many of our respondents believed that patients drive inappropriate services more often than physicians, but that patients largely lack the information to make these informed decisions. Strengthening communication of the campaign to the general public, while targeting specific high-yield areas of patient utilization, may help further reduce use of certain services. Furthermore, though a majority of respondents identified cost to society as an important factor in the decision to use or not use an intervention, less than half of respondents reported awareness of the cost of tests and treatments they prescribe. Numerous other studies have found deficits in both self-reported and actual awareness of the costs of medical care in the US.10,13 Surveys of Canadian physicians have demonstrated very poor cost awareness among both family physicians and residents.14,15 While enhancing knowledge of low-value areas of care is the primary goal of campaigns such as CWC, it is possible that physician education on the costs of tests and treatments would lead to further improvements in resource utilization. Finally, evidence suggests that physicians who value cost consciousness are more likely to avoid the use of low-value services, while greater knowledge of guidelines alone is not associated with reduced use of low-value services.16 Accordingly, efforts may be further focused on enhancing a sense of cost consciousness among trainees and physicians.LimitationsOur survey does possess several limitations. Firstly, our response rate was only 33%; thus, it remains possible that our sample was not fully representative of the target population, and we cannot rule out a selection bias favouring respondents more familiar with the CWC campaign. Secondly, we restricted our population to physicians associated with McMaster University. We cannot extrapolate these findings to physicians associated with other universities or physicians in non-academic settings, especially given the fact that local CWC communication initiatives have been occurring to variable extents across the country. Thirdly, we were unable to avoid the possibility that respondents were able to search for their specialty-specific recommendations while completing the survey. However, we have no reason to believe respondents would have any incentive to do so. Lastly, we were unable to account for physicians who identify with more than one medical specialty.ConclusionsDespite general awareness of the CWC campaign, most physicians cannot describe recommendations targeted to their own specialty. Nonetheless, many of these physicians report already practicing in compliance with these recommendations. Multiple barriers to implementing change were identified, including the potential of recommendations targeting lower-yield areas of care, patient requests for tests and treatment, physician awareness of cost, and concern regarding medico-legal risk. Future studies are required to explore awareness of the campaign in other academic and community sites across the country. Additionally, future efforts should be directed towards identifying methods of improving communication of current CWC recommendations, including the potential for targeting both specific recommendations and institutions with low baseline compliance, and to determine areas of care that would most benefit from additional recommendations.

Purpose The purpose of this study is to analyze the relationship between citizen participation and the level of trust in government’s decisions and policies; as well as examining the impact of disclosure of information on the level of citizens’ engagement with governments’ projects. In addition, testing the real motives behind Egyptian citizens’ participation in financing national projects. The study is applied to the “New Suez Canal,” which was finished in only one year opposing the three years implementation period suggested by some studies. Design/methodology/approach The researcher depended on secondary and primary data as well in working on this paper. She used secondary data gathered from scholars and from domestic and international institutions. Then, she conducted a field study and collected data through distributing 384 Likert Scale questionnaires containing 34 self-administered among respondents to test the following: 1. Citizens perceptions regarding the level of trust in government’s decisions and policies. 2. The impact of citizens’ trust on their willingness to participate in governments’ projects. 3. Is ‘public service motivation’ (PSM) behind citizens’ willingness of participating in national projects. 4. Is the ‘high expected profit of Suez Canal Investment Certificates’ behind citizens participation in national projects. Findings H1 and H2 have been accepted as trust, transparency and citizen participation proved to be important pillars of building a participatory government. Moreover, citizens’ participation in national projects encouraged national and international enterprises to invest in the canal provision. H3 and H4 are accepted and the statistical study revealed dual contradicting results regarding the motive of citizens’ financial participation in the New Suez Canal project. The justification for the contradiction is that right after the 2011 up-rise, Egyptian citizens were overwhelmed with patriot emotions and feelings pushing them to participate in national projects. At the same time this patriot drive was moderated by the “performance-based rewards and citizens” self-interests’ pushed by the Egyptian government (offering a high-interest rate for Suez Canal Certificates at that time). Citizens might be motivated to participate in national projects triggered by many factors: public service drive – patriotism or self-interest. Research limitations/implications The study needs further deeper investigation and empirical pieces of evidence to answer the following questions: would different participatory actions result differently in other circumstances? Do individuals’ levels of PSM vary over time? Besides, the researcher needs to find ways to test PSM against various motives such as self-interest, which needs to be confirmed empirically. Practical implications The author came up with important recommendations for central government and decision-makers in Egypt and is based upon the study’s statistical results. The most important recommendations were: central government and decision-makers should frame a policy designed to promote citizens’ participation in decision-making drawing on the guidelines for civil participation in political decision-making. Decision-makers in the central government should work local and regional authorities to update and improve local and regional regulations concerning the participation of citizens in local public life and promote a culture of democratic participation shared by communities and local authorities. Performance-based rewards (high-interest rate) are moderating the citizens’ public service motivation (PSM – patriot sense) and citizens may be motivated by different factors such as public service drive – patriotism or self-interest. Social implications The study is tackling an important issue, which is civil participation in political decision-making. It is also discussing promoting cultural awareness regarding the importance of democratic participation shared by communities and local authorities. The study came up with certain findings proving Egyptian civil society’s willingness in participating with the government in national projects; believing in its socio-economic benefits. Originality/value Finally, the study is of value, as it could be considered a pilot study representing the outcomes of citizen participation in national projects; in addition, it can be considered as a road map to policymakers. Moreover, the findings provide a set of recommendations and policies for governments and decision-makers to undertake tangible actions to accelerate citizen participation in further projects and decisions and be able to establish a democratic system in developing countries.

Photo by Sébastien Goldberg on Unsplash ABSTRACT Rohingya women face challenges that ought to be acknowledged and addressed to ensure that when they seek health care, they can act autonomously and decide freely among available options. Self-determination theory offers valuable insight into supporting these women within their unique situations. INTRODUCTION In August of 2017, military and paramilitary forces in Myanmar began purging the Rohingya Muslim population from the country, motivated by anti-Muslim prejudice of the Buddhist political and social majority. Mass murder, property destruction, kidnapping, torture, and sexual violence still affect Rohingya communities. As a result, more than a million individuals have fled Myanmar.[1] As of February 2021, approximately 880,000 Rohingya Muslims have taken refuge in Cox’s Bazar, Bangladesh, the site of the largest refugee camps in the world.[2] The public health focus in these camps is on treatment of physical ailments and infectious diseases.[3] While women of reproductive age and adolescent girls experience the highest level of violence among Rohingya communities in both Myanmar and Bangladesh, they have consistently lacked access to sufficient sexual and reproductive care. In 1994, the Women’s Commission for Refugee Women and Children exposed issues surrounding the sexual and reproductive health of displaced populations and propelled the recognition of SRH as a human right.[4] Human rights interventionists and public health officials have made progress in the integration of sexual and reproductive health education, facilities, and resources into refugee camps in Cox’s Bazar. This includes the introduction of menstrual cleanliness facilities and educational conversations. However, Rohingya women and male cultural leaders, or gatekeepers, remain reluctant to accept these resources and education.[5] The prevalence of gender-based violence against women and restrictive policies enforced by the Bangladesh government heighten the barriers to the effective introduction of sexual and reproductive health resources and services.[6] A wealth of literature has pushed for the extension of clinical duties of beneficence and non-maleficence in the diagnosis and treatment of refugee and asylum-seeking communities.[7] Additionally, extensive research on Rohingya refugee communities has searched for ways to work around the complex social history and to accommodate power structures by integrating gatekeepers into SRH discussions.[8] However, as interventions have sought to overcome cultural and religious barriers, they have largely overlooked the protection of autonomy of sexual and reproductive health patients in Cox’s Bazar. This paper argues two points. First, attempts at improving outcomes in Cox’s Bazar ought to lead to Rohingya women’s autonomy and self-determination, both in mitigating control of male leaders over sexual and reproductive decisions and in ensuring the understanding and informed consent between patients and providers. Second, policy decisions ought to ensure post-treatment comprehensive care to shield Rohingya women from retribution by male community members. Self-determination theory offers guidance for state leaders and healthcare providers in pursuing these goals. l. Barriers to Sexual and Reproductive Health Services for Rohingya Women As part of its anti-Muslim narrative, the Buddhist majority has painted Rohingya women as hyper-reproductive. False narratives “of a Rohingya plan to spread Islam by driving demographic shifts” and accusations against Rohingya women for having “unusually large families” have motivated violent behavior and discriminatory regulations against Rohingya communities.[9] In reality, demographic data shows that “the Rohingya population has remained stable at 4% since 1980.”[10] In 2013, the government of Myanmar imposed regulations on Rohingya families in the Rakhine state, the region with the highest population of Rohingya Muslims, enforcing a two-child limit and requiring that Rohingya women obtain government authorization to marry and take a pregnancy test before receiving such permission. The majority has also subjected Rohingya females to acts of sexual violence to ostracize them and “dilute” Rohingya identity.[11] As a result, Rohingya women in Cox’s Bazar experience unique illnesses and vulnerabilities requiring imminent treatment. Due to national policies in Bangladesh, “Rohingya [women] cannot receive HIV/AIDS testing and treatment in camps; birth control implants delivered by midwives; and comprehensive abortion care.”[12] Additionally, in accordance with patriarchal Rohingya community structure, male gatekeepers hold high authority over sexual and reproductive decisions of women, evidenced by the persistence of gender-based violence within refugee camps and traditional practices such as the marriage of minor girls to older Rohingya men.[13] Surveys of community members reveal that cultural and religious stigma against sexual and reproductive health care exists among these male gatekeepers as well as Rohingya women.[14] Due to their cultural and political position, Rohingya women are subject to unique power relations. This paper analyzes the ethical dilemmas that arise from two of those power relations: Rohingya women’s relationships with male gatekeepers and their relationships with interventionist healthcare providers. ll. Ethics of Including Male Community Members in Decisions Affecting Women’s Healthcare Autonomy A November 2019 survey of Rohingya women in Cox’s Bazar that had married or given birth within the past two years found that “around one half of the female Rohingya refugees do not use contraceptives, mainly because of their husbands’ disapproval and their religious beliefs.”[15] There are widespread misconceptions such as the belief that Islam does not permit the use of contraceptives.[16] The existence of such misconceptions and the power husbands and male leaders hold over the delivery of treatment creates dilemmas for healthcare practitioners in conforming to ethical principles of care. lll. Beneficence in Providing Care to Refugees While public health scholars and government officials hold divided opinions on the level of treatment required to fulfill refugees’ right to sexual and reproductive health care, most support enough care to ensure physical and psychological well-being.[17] Beneficence requires that healthcare providers and states “protect the rights of others[,] prevent harm from occurring to others[, and] remove conditions that will cause harm to others.”[18] Under the principle of beneficence, there is a duty to provide sexual and reproductive treatment to Rohingya women in Cox’s Bazar that is comparable to that received by citizens of the host state. In addition, the ethical principle of nonmaleficence may call for the creation of specialized care facilities for refugee communities, because a lack of response to refugees’ vulnerability and psychological trauma has the potential to generate additional harm.[19] In response to gendered power relations among the Rohingya community, husbands and male leaders are included in decisions surrounding maternal health and sexual and reproductive care for women. For example, healthcare professionals “have been found to impose conditions on SRH [sexual reproductive health] care that are not stated in the national… [menstrual regulation] guidelines, such as having a husband’s permission.”[20] The refugee healthcare community could do more to mitigate the potential of retribution taken by male community members against women that accept care by dispelling common misconceptions and precluding male community members from influencing female reproductive choices.[21] However, some current practices allow the infiltration of male community leaders and husbands into the diagnosis, decision-making, and treatment spaces. Deferring decisions to male leaders for the sake of expediency risks conditioning women’s access to care on male buy-in and diminishes Rohingya women’s autonomy over their sexual and reproductive health. lV. Male Influence and Female Autonomy Ensuring patients control their own treatment decisions is an essential component of the ethical obligation of healthcare professionals to respect patients’ autonomy. While patients can exercise their autonomy to accept the direction of the community, their autonomy is undermined when “external sources or internal states… rob [such persons]… of self-directedness.”[22] Sexual and reproductive health research on Rohingya women revealed that the presence of male family members during conversations “made female respondents uncomfortable to speak openly about their SRH [sexual and reproductive health]related experiences.”[23] The same study found that when male family members were absent, Rohingya women were more transparent and willing to discuss such topics.[24] These findings indicate that the mere presence of male family members exerts control over Rohingya women in conversations with practitioners. Male involvement also stalls conversations between providers and Rohingya women which may harm the achievement of understanding and informed consent in diagnosis and treatment spaces.[25] Women do have the option of bringing their male community leaders and family members into sexual health discussions. Yet healthcare providers ought to monitor patients individually and avoid programmatic decision making regarding male involvement in the treatment space. While it is the ethical imperative of health interventionists and the state of Bangladesh to fulfill the duties of care required by the principles of beneficence and non-maleficence, the sole prioritization of expanding sexual and reproductive health care in Cox’s Bazar risks ignoring autonomy. V. Ethics of Paternalism in Provide-Patient Relations Rohingya women’s negative beliefs about contraceptives, such as the belief that they cause irreversible sterilization, are the second largest factor inhibiting their use.[26] To an extent, the Rohingya are justified in their skepticism. Prior to the 1990’s, Bangladesh used nonconsensual sterilization as a mechanism of population control to attain access to international aid. Though the international conversation surrounding reproduction shifted its focus towards reproductive rights following the 1994 UN International Conference on Population and Development, delivery of reproductive care in the global South is frequently characterized by lack of transparency and insufficient patient understanding of the risks and consequences of treatment. Additionally, women’s lack of control impacts follow-up care and long-term contraception. For example, when women seek the removal of implantable contraceptives, healthcare professionals often refuse to perform the requisite operation.[27] Patients must understand the risks of treatment in their own culture and circumstances where societal views, misconceptions, or fears may influence healthcare practices. Healthcare providers need to recognize the coercive potential they hold in their relations with patients and guard against breaches of patient autonomy in the delivery of treatment. In accordance with the principle of beneficence, healthcare providers treating refugees or individuals seeking asylum ought to abide by the same fiduciary responsibilities they hold toward citizens of the host state.[28] When patients show hesitancy or refusal toward treatment, healthcare providers ought to avoid achieving treatment by paternalistic practice such as “deception, lying, manipulation of information, nondisclosure of information, or coercion.”[29] Although well-intentioned, this practice undermines the providers’ obligation to respect patients’ autonomy.[30] The hesitancy of Rohingya women to accept some sexual or reproductive health care does not justify intentional lack of transparency, even when that treatment furthers their best health interests. However, paternalistic actions may be permissible and justified during medical emergencies.[31] Vl. Informed Consent Respecting Rohingya women’s autonomy also places affirmative duties on healthcare providers to satisfy understanding and informed consent. However, language barriers and healthcare providers’ misconceptions about Rohingya religion and culture impede the achievement of these core conditions of autonomy for Rohingya women.[32] In an interview, a paramedic in Cox’s Bazar described the types of conversations healthcare providers have with Rohingya women in convincing them to accept menstrual regulation treatment, a method to ensure that someone is not pregnant after a missed period: “We tell them [menstrual regulation] is not a sin… If you have another baby now, you will get bad impact on your health. You cannot give your children enough care. So, take MR [menstrual regulation] and care for your family.”[33] This message, like others conveyed to Rohingya women in counseling settings, carries unvalidated assumptions regarding the beliefs, needs, and desires of clients without making a proper attempt to confirm the truth of those assumptions. Healthcare providers’ lack of cultural competence and limited understanding of Bangladesh’s national reproductive health policy complicates communication with Rohingya women. Additionally, the use of simple language, though recommended by the WHO’s guideline on Bangladesh’s policy, is inadequate to sufficiently convey the risks and benefits of menstrual regulation and other treatments to Rohingya women.[34] For informed consent to be achieved, “the patient must have the capacity to be able to understand and assess the information given, communicate their choices and understand the consequences of their decision.”[35] Healthcare providers must convey sufficient information regarding the risks, benefits, and alternatives of treatment as well as the risks and benefits of forgoing treatment.[36] Sexual and reproductive health policies and practices must aim to simultaneously mitigate paternalism, promote voluntary and informed choice among Rohingya women, and foster cultural and political competency among healthcare providers. Vll. Self-Determination Theory Self-determination theory is a psychological model that focuses on types of natural motivation and argues for the fulfillment of three conditions shown to enhance self-motivation and well-being: autonomy, competence, and relatedness.[37] According to the theory, autonomy is “the perception of being the origin of one’s own behavior and experiencing volition in action;” competence is “the feeling of being effective in producing desired outcomes and exercising one’s capacities;” and, relatedness is “the feeling of being respected, understood, and cared for by others.”[38] Bioethicists have applied self-determination theory to health care to align the promotion of patient autonomy with traditional goals of enhancing patient well-being. Studies on the satisfaction of these conditions in healthcare contexts indicate that their fulfillment promotes better health outcomes in patients.[39] Like principlism, self-determination theory in Cox’s Bazar could allow for increased autonomy while maximizing the well-being of Rohingya women and behaving with beneficence Fostering self-determination requires that healthcare professionals provide patients with the opportunity and means of voicing their goals and concerns, convey all relevant information regarding treatment, and mitigate external sources of control where possible.[40] In Cox’s Bazar, health care organizations in the region and the international community can act to ensure women seeking health care are respected and able to act independently. A patient-centered care model would provide guidelines for the refugee setting.[41] Providers can maximize autonomy by utilizing language services to give SRH patients the opportunity and means to voice their goals and concerns, disclose sufficient information about risks, benefits, and alternatives to each procedure, and give rationales for each potential decision rather than prescribe a decision. They can promote the feeling of competence among patients by expressly notifying them of the level of reversibility of each treatment, introducing measures for health improvement, and outlining patients’ progress in their SRH health. Finally, they can promote relatedness by providing active listening cues and adopting an empathetic, rather than condescending, stance.[42] Healthcare organizations ought to provide training to promote cultural competency and ensure that practitioners are well-versed on national regulations regarding sexual reproductive health care in Bangladesh to avoid the presumption of patients’ desires and the addition of unnecessary barriers to care. Increased treatment options would make autonomy more valuable as women would have more care choices. Given the historical deference to international organizations like the UN and World Bank, multilateral and organizational intervention would likely bolster the expansion of treatment options. International organizations and donors ought to work with the government of Bangladesh to offer post-treatment comprehensive care and protection of women who choose treatment against the wishes of male community members to avoid continued backlash and foster relatedness.[43] CONCLUSION Rohingya women in Cox’s Bazar, Bangladesh face unique power relations that ought to be acknowledged and addressed to ensure that when they seek health care, they are able to act autonomously and decide freely among available options. While providers have duties under the principles of beneficence and non-maleficence, patient well-being is hindered when these duties are used to trump the obligation to respect patient autonomy. Current approaches to achieving sexual and reproductive health risk the imposition of provider and communal control. Self-determination theory offers avenues for global organizations, Bangladesh, donors, and healthcare providers to protect Rohingya women’s autonomous choices, while maximizing their well-being and minimizing harm. DISCLAIMER: As a male educated and brought up in a Western setting, I acknowledge my limitations in judgement about Rohingya women’s reproductive care. Their vulnerability and health risks can never be completely understood. To some extent, those limitations informed my theoretical approach and evaluation of Rohingya women's SRH care. Self-determination theory places the patients’ experiences and judgement at the center of decision-making. My most important contributions to the academic conversation surrounding Rohingya women are the identification of dilemmas where autonomy is at risk and advocating for self-determination. - [1] Hossain Mahbub, Abida Sultana, and Arindam Das, “Gender-based violence among Rohingya refugees in Bangladesh: a public health challenge,” Indian Journal of Medical Ethics (June 2018):1-2, https://doi.org/10.20529/IJME.2018.045. [2] “UN teams assisting tens of thousands of refugees, after massive fire rips through camp in Bangladesh,” United Nations, last modified March 23, 2021, https://news.un.org/en/story/2021/03/1088012#:~:text=The%20Kutupalong%20camp%20network%2C%20which,(as%20of%20February%202021). [3] Hossain et al., “Gender-based violence,” 1-2. [4] Benjamin O. Black, Paul A, Bouanchaud, Jenine K. Bignall, Emma Simpson, Manish Gupta, “Reproductive health during conflict,” The Obstetrician and Gynecologist 16, no. 3 (July 2014):153-160, https://doi.org/10.1111/tog.12114. [5] Margaret L. Schmitt, Olivia R. Wood, David Clatworthy, Sabina Faiz Rashid, and Marni Sommer, “Innovative strategies for providing menstruation-supportive water, sanitation and hygiene (WASH) facilities: learning from refugee camps in Cox's bazar, Bangladesh,” Conflict and Health Journal 15, no. 1 (Feb 2021):10, https://doi.org/10.1186/s13031-021-00346-9. [6] S M Hasan ul-Bari, and Tarek Ahmed, “Ensuring sexual and reproductive health and rights of Rohingya women and girls,” The Lancet 392, no. 10163:2439-2440, https://doi.org/10.1016/S0140-6736(18)32764-8. [7] Janet Cleveland, and Monica Ruiz-Casares, “Clinical assessment of asylum seekers: balancing human rights protection, patient well-being, and professional integrity,” American Journal of Bioethics 13, no. 7 (July 2013):13-5, https://doi.org/10.1080/15265161.2013.794885.; Christine Straehle, “Asylum, Refuge, and Justice in Health,” Hastings Center Report 49, no. 3 (May/June 2019):13-17, https://doi.org/10.1002/hast.1002. 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Melnikas, Sigma Ainul, Iqbal Ehsan, Eashita Haque, and Sajeda Amin, “Child marriage practices among the Rohingya in Bangladesh,” Conflict and Health Journal 14, no. 28 (May 2020), https://doi.org/10.1186/s13031-020-00274-0. [14] Nuruzzaman Khan, Mofizul Islam, Mashiur Rahman, and Mostafizur Rahman, “Access to female contraceptives by Rohingya refugees, Bangladesh,” Bull World Health Organ, 99, no.3 (March 2021):201-208, https://doi.org/10.2471/BLT.20.269779. [15] Khan et al., “Access to,” 201-208. [16] Khan et al., “Access to,” 201-208. [17] Ramin Asgary, and Clyde L. Smith, “Ethical and professional considerations providing medical evaluation and care to refugee asylum seekers,” American Journal of Bioethics 13, no. 7 (July 2013):3-12, https://doi.org/10.1080/15265161.2013.794876.; Cleveland and Ruiz-Casares, “Clinical assessment,” 13-5.; Straehle, “Asylum,” 13-17. [18] Tom L. Beauchamp, and James Childress, Principles of Biomedical Ethics. 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[41] Podlog and Brown, “Self-determination Theory.” [42] Podlog and Brown, “Self-determination Theory.” [43] Podlog and Brown, “Self-determination Theory.”