Decisive Evidence Research Articles

FP-CNN: Fuzzy pooling-based convolutional neural network for lung ultrasound image classification with explainable AI

The COVID-19 pandemic wreaks havoc on healthcare systems all across the world. In pandemic scenarios like COVID-19, the applicability of diagnostic modalities is crucial in medical diagnosis, where non-invasive ultrasound imaging has the potential to be a useful biomarker. This research develops a computer-assisted intelligent methodology for ultrasound lung image classification by utilizing a fuzzy pooling-based convolutional neural network FP-CNN with underlying evidence of particular decisions. The fuzzy-pooling method finds better representative features for ultrasound image classification. The FPCNN model categorizes ultrasound images into one of three classes: covid, disease-free (normal), and pneumonia. Explanations of diagnostic decisions are crucial to ensure the fairness of an intelligent system. This research has used Shapley Additive Explanation (SHAP) to explain the prediction of the FP-CNN models. The prediction of the black-box model is illustrated using the SHAP explanation of the intermediate layers of the black-box model. To determine the most effective model, we have tested different state-of-the-art convolutional neural network architectures with various training strategies, including fine-tuned models, single-layer fuzzy pooling models, and fuzzy pooling at all pooling layers. Among different architectures, the Xception model with all pooling layers having fuzzy pooling achieves the best classification results of 97.2% accuracy. We hope our proposed method will be helpful for the clinical diagnosis of covid-19 from lung ultrasound (LUS) images.

Use of Real-World Evidence for Drug Regulatory Decisions in China: Current Status and Future Directions.

Real-world data (RWD) and real-world evidence (RWE) have garnered great interest for supporting drug research and development (R&D) by medical researchers and regulators in recent years. The application and development of RWD/E in drug regulatory decision-making have been vigorously promoted in China. This study seeks to provide a broad overview of how RWE has been contributing to drug regulatory decisions in China. In this paper, we review the development of RWD and RWE, summarize key elements that promote application of RWE, introduce relevant methods and guidelines, elaborate on the opportunities and challenges of RWE in regulatory decision-making in China, and put forward suggestions to promote the application of RWE in China's regulatory decision-making and to further facilitate innovative drug evaluation and regulation.

Indigenising systematic reviews with a collaborative model of 'training the trainers'.

Developing a workforce with the skills to produce and make judicious use of evidence for policy and practice decisions requires trainers who can tailor evidence and training to policy and practice priorities. To describe how a collaborative learning model adapted a systematic review course to suit Indian nurse educators and research scholars in the conduct and use of systematic reviews. A collaborative learning team of academics and research scholars brought together expertise in nursing education in India, and evidence synthesis in India and the UK. Participants found the course was highly beneficial, enhanced independent and critical thinking, and instilled them with the confidence and skills to deliver such courses to Indian researchers, nurses and other healthcare professionals. Contextualising materials and methods to participants' experiences made learning more relatable. The use of adult learning approaches enabled participants to apply the same approaches when leading training in their own institutions and underpinned long-term sustainable working relationships between facilitators and learners, leading to new studies and new resources to support evidence-informed decision-making. An educational intervention on 'indigenising systematic reviews' with online collaborative learning can produce improvements in the knowledge and skills of participants. Advantages of this educational approach include its flexibility, active involvement of participants and sustainable partnership building. The principles and methods used could be replicated in any setting to train trainers.

A systematic literature review of fuzzy-weighted zero-inconsistency and fuzzy-decision-by-opinion-score-methods: assessment of the past to inform the future

The Fuzzy-Weighted Zero-Inconsistency (FWZIC) and Fuzzy-Decision-by-Opinion-Score-Method (FDOSM) are considered the recent advance methods. FDOSM generates a ranking for possible alternatives, while FWZIC produces a weight for criterion. Keeping up with the stream of academic publications on the FDOSM and FWZIC methods is complicated. This study aims to provide a comprehensive review of the literature on the latest advanced methods of MCDM in order to reorganize the findings of the previous literature and provide decisive evidence for ongoing research and future studies. Based on previous literature, the current study used the Prisma method to collect data from multiple databases such as IEEE Xplore®, ScienceDirect, and Web of Science. There were 45 papers discovered relevant to this subject; however, only 23 studies were relevant for the FDOSM & FWZIC study. The results included theoretical and practical implications. Theoretically, additions of new aggregation operators or usage of new fuzzy sets in the FDOSM & FWZIC model to solve the uncertainty problem are the key obstacles. Practically, agriculture and architectural fields are considered to be a hotspot of research. Finally, a number of potential points for future research to develop methods with high certainty and low ambiguity are presented.

Enhancing the Introduction and Scale Up of Self-Administered Injectable Contraception (DMPA-SC) in Health Systems (the EASIER Project): Protocol for Embedded Implementation Research.

The introduction of self-administered injectable contraception presents an opportunity to address the unmet need for family planning. As ministries of health scale up self-administered injectable contraception, there is a scarcity of knowledge on the implementation practices and contextual conditions that help and hinder these efforts. The World Health Organization has launched the "enhancing self-administered family planning through embedded research project" (EASIER) to address this challenge. EASIER's objectives are to: (1) assess the coverage of self-injectable contraception, and the readiness of health systems to integrate it into the contraceptive method mix; (2) document strategies used to introduce and scale up self-injectable contraception and understand practices that have led to success and challenges; (3) identify the contextual factors that affect the adoption and implementation of self-injectable contraception throughout health systems; (4) understand whether implementation addresses users' preferences and needs; (5) strengthen collaboration between decision makers, researchers, and implementers; support and build capacity to use evidence. EASIER developed a global protocol that implementation research (IR) teams in Burkina Faso, Ghana, and Kenya adapted into country-level embedded IR projects. In all countries (1) at the national level, IR teams evaluate the policy environment for scaling up by conducting a desk review and in-depth interviews; (2) at the local level, IR teams implement quantitative questionnaires on structural and organizational readiness to integrate self-injection into the method mix; (3) in "case study" localities, IR teams conduct in-depth interviews and focus group discussions with implementers, method users, and community members; and (4) IR teams use participatory action research to elicit stakeholder participation and translate findings into programmatic decisions. EASIER has been launched in all 3 countries. Preliminary findings are available from Burkina Faso and Kenya. In Burkina Faso, IR teams identified the need to strengthen health worker training approaches to ensure that family planning providers at primary health care facilities are adequately oriented to depo-medroxyprogesterone acetate subcutaneous (DMPA-SC) and self-injection and capacitated to initiate women to the method. In addition, they report the need for service communication strategies that reach potential users of the method with knowledge about self-injection and how to initiate the practice. In Kenya, the findings illuminate the need for practice guidelines that county health teams can use to coordinate the rollout of self-administered DMPA-SC. In addition, Kenya's findings underscore the importance of addressing logistical bottlenecks to help avoid stock-outs. EASIER presents a strategy to embed IR in contraceptive method introduction and scale-up, address local knowledge needs, devise ways to maximize the impact of new technologies in health systems, and build capacity for using evidence in programmatic decisions. Adaptation and implementation of country-level IR studies will advance the use of IR to strengthen family planning programs. Australia New Zealand Clinical Trials Registry ACTRN12622001228774; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=384534&isReview=true. DERR1-10.2196/44222.

Use of Real-World Evidence in Neuroscience-Related New Drug and Biologics License Applications for Novel Therapeutics.

The US Food and Drug Administration (FDA) is evaluating the potential use of real-world evidence (RWE) in regulatory decision making. Some groups have evaluated the use of RWE in regulatory submissions in the United States and abroad, reporting that reliance on RWE to support new product approvals is relatively common. Confusion regarding the use of RWE in drug-approval decisions may arise, however, based on different application of the terms real-world data (RWD) and RWE. We evaluated RWE in new drug applications (NDAs) and biologics license applications (BLAs) from January 2019 to June 2021 for novel drugs and biologics approved by the FDA with indications related to psychiatry, neurology, pain, or sedation (here, termed neuroscience-related). We sought to determine whether the submissions included RWE and to describe the types of data and study designs used. Thirty neuroscience-related NDAs or BLAs were identified for novel drugs and biologics approved during the time-period of interest. Among these approvals, three applications (10%) were adjudicated as containing RWE, one of which included RWE as primary evidence of effectiveness. Our findings highlight how different operational definitions of the terms RWD and RWE can result in demonstrably different reporting of the use of RWE in regulatory decision making for neuroscience-related novel drugs and biologics. A better understanding of this topic, along with awareness of regulatory definitions of RWE, are important factors to promote accurate tracking and reporting of regulatory submissions involving RWE. These factors can also improve awareness among the stakeholder community regarding the role of RWD and RWE in regulatory decision making.

GRADE guidance 23: considering cost-effectiveness evidence in moving from evidence to health-related recommendations

BackgroundThis is the 23rd in a series of articles describing the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to grading the certainty of evidence and strength of recommendations for systematic reviews, health technology assessments, and clinical guideline development. ObjectivesWe outline how resource utilization and cost-effectiveness analyses are integrated into health-related recommendations, using the GRADE Evidence to Decision (EtD) frameworks. Study Design and SettingThrough iterative discussions and refinement, in-person, and online meetings, and through e-mail communication, we developed draft guidance to incorporate economic evidence in the formulation of health-related recommendations. We developed scenarios to operationalize the guidance. We presented a summary of the results to members of the GRADE Economic Evaluation Project Group. ResultsWe describe how to estimate the cost of preventing (or achieving) an event to inform assessments of cost-effectiveness of alternative treatments, when there are no published economic evaluations. Evidence profiles and Summary of Findings tables based on systematic reviews of cost-effectiveness analyses can be created to provide top-level summaries of results and quality of multiple published economic evaluations. We also describe how this information could be integrated in GRADE’s EtD frameworks to inform health-related recommendations. Three scenarios representing various levels of available cost-effectiveness evidence were used to illustrate the integration process. ConclusionThis GRADE guidance provides practical information for presenting cost-effectiveness data and its integration in the development of health-related recommendations, using the EtD frameworks.

Distortion of Mendelian segregation across the Angus cattle genome uncovering regions affecting reproduction

Nowadays, the availability of genotyped trios (sire-dam-offspring) in the livestock industry enables the implementation of the transmission ratio distortion (TRD) approach to discover deleterious alleles in the genome. Various biological mechanisms at different stages of the reproductive cycle such as gametogenesis, embryo development and postnatal viability can induce signals of TRD (i.e., deviation from Mendelian inheritance expectations). In this study, TRD was evaluated using both SNP-by-SNP and sliding windows of 2-, 4-, 7-, 10- and 20-SNP across 92,942 autosomal SNPs for 258,140 genotyped Angus cattle including 7,486 sires, 72,688 dams and 205,966 offspring. Transmission ratio distortion was characterized using allelic (specific- and unspecific-parent TRD) and genotypic parameterizations (additive- and dominance-TRD). Across the Angus autosomal chromosomes, 851 regions were clearly found with decisive evidence for TRD. Among these findings, 19 haplotypes with recessive patterns (potential lethality for homozygote individuals) and 52 regions with allelic patterns exhibiting complete or quasi-complete absence for homozygous individuals in addition to under-representation (potentially reduced viability) of the carrier (heterozygous) offspring were found. In addition, 64 (12) and 20 (4) regions showed significant influence on the trait heifer pregnancy at p-value < 0.05 (after chromosome-wise false discovery rate) and 0.01, respectively, reducing the pregnancy rate up to 15%, thus, supporting the biological importance of TRD phenomenon in reproduction.

Evidence Synthesis towards a Holistic Landscape Decision Framework: Insight from the Landscape Decisions Programme

The development of a decision framework for landscape governance and management has become one of the prioritised policy instruments for actualising policy objectives related to agri-food systems, biodiversity conservation, nature restoration, environmental management, climate change mitigation and adaptation, net-zero greenhouse gas emissions, and the transition to renewable energy supplies. However, the landscape lens in policy making is challenging because of the diverse landscape archetypes, environmental problems, and diverging policy targets that it must address. This highlights the importance of having a robust, evidence-based landscape decision framework. To address this issue, this study undertook a transdisciplinary synthesis of research outputs from the Landscape Decisions Programme (LDP). This study compiles and synthesises outputs from the LDP projects in the context of the relevant literature to develop an understanding of the relationships among the emerging evidence with respect to decision making for sustainable and multifunctional landscapes. The synthesis identified six themes that define the drivers of landscape decisions, and four themes that define the dominant methodological approaches used to generate evidence for landscape decisions. The emergent themes from the synthesis were distilled into five principles that can be used as a basis for the development of a holistic landscape decision framework.

Identification of potentially relevant metals for the etiology of autism by using a Bayesian multivariate approach for partially censored values

Heavy metals are known to be able to cross the placental and blood brain barriers to affect critical neurodevelopmental processes in the fetus. We measured metal levels (Al, Cd, Hg, Li, Pb and Zn) in the cord blood of newborns and in the serum of the same children at 5 years of age, and compared between individuals with or without (controls) autism spectrum disorder (ASD) diagnosis. The samples were from a biobank associated with the All Babies in Southeast Sweden (ABIS) registry. We proposed a Bayesian multivariate log-normal model for partially censored values to identify potentially relevant metals for the etiology of ASD. Our results in cord blood suggest prenatal Al levels could be indicative of later ASD incidence, which could also be related to an increased possibility of a high, potentially toxic, exposure to Al and Li during pregnancy. In addition, a larger possibility of a high, potentially beneficial, exposure to Zn could occur during pregnancy in controls. Finally, we found decisive evidence for an average increase of Hg in 5-year-old ASD children compared to only weak evidence for controls. This is concordant with previous research showing an impaired ability for eliminating Hg in the ASD group.

Combining local aggregate and treatment research findings to inform clinical decision making in youth mental health care

Many mental health practitioners have been reluctant to incorporate findings from randomized control trials (RCTs) into their community care treatment approaches. This reluctance might arise from perceptions that treatment manuals are too inflexible or that recommendations from the research literature do not apply to their own service settings. At present, there are no easily accessible clinical decision making tools that allow for the integration of both research and local findings in treatment planning. Local aggregate evidence is defined as case-specific data aggregated across multiple clients into meaningful composite units (Daleiden & Chorpita, 2005). Thus, the present study aims to describe the development and design of a set of clinical decision making tools that visually depict distilled treatment research findings along with data aggregated from local service patterns related to a variety of specific treatment targets. These tools allow community care providers and stakeholders to simultaneously consider both sets of evidence in pertinent clinical decision making situations (e.g., at treatment start, when treatment is not progressing). Sample findings are presented across different treatment targets and levels of care. Implications for case planning and case review, system of care improvement, and future RCT research are discussed.

Using evidence to decision frameworks led to guidelines of better quality and more credible and transparent recommendations

Background and ObjectivesTo determine whether the use of Evidence to Decision (EtD) frameworks is associated to higher quality of both guidelines and individual recommendations. MethodsWe identified guidelines recently published by international organizations that have methodological guidance documents for their development. Pairs of researchers independently extracted information on the use of these frameworks, appraised the quality of the guidelines using the Appraisal of Guidelines, Research and Evaluation II Instrument (AGREE-II), and assessed the clinical credibility and implementability of the recommendations with the Appraisal of Guidelines for REsearch & Evaluation Recommendations Excellence (AGREE-REX) tool. We conducted both descriptive and inferential analyses. ResultsWe included 66 guidelines from 17 different countries, published in the last 5 years. Thirty guidelines (45%) used an EtD framework to formulate their recommendations. Compared to those that did not use a framework, those using an EtD framework scored higher in all domains of both AGREE-II and AGREE-REX (P < 0.05). Quality scores did not differ between the use of the The Grading of Recommendations Assessment, Development and Evaluation–EtD framework (17 guidelines) or another EtD framework (13 guidelines) (P > 0.05). ConclusionThe use of EtD frameworks is associated with guidelines of better quality, and more credible and transparent recommendations. Endorsement of EtD frameworks by guideline developing organizations will likely increase the quality of their guidelines.

Obesity in Refugees post-resettlement in a high-income country: a meta-analysis.

Refugees have a high prevalence of obesity post resettlement, but few studies have compared their risk of obesity to those of the host population. We systematically investigated the association between refugee status and obesity after resettlement in a high-income nation. We searched PubMed, Embase, OpenGrey and bibliographies of retrieved articles, with no date, location, and language restrictions, for observational studies assessing obesity rates in resettled refugees compared to the host population. Nine studies were analyzed. We found no evidence of increased risk of obesity among refugees compared to the host population, with significant heterogeneity across studies. However, the risk of obesity among refugee men were significantly lower than the host population. The heterogeneity between studies calls for more high-quality research to examine the risk of obesity among refugees compared to the host population in high-income countries. This will enable results to be pooled to provide more decisive evidence about obesity trends among refugees post migration in a high-income nation.

A lifecycle framework illustrates eight stages necessary for realizing the benefits of patient-centered clinical decision support.

The design, development, implementation, use, and evaluation of high-quality, patient-centered clinical decision support (PC CDS) is necessary if we are to achieve the quintuple aim in healthcare. We developed a PC CDS lifecycle framework to promote a common understanding and language for communication among researchers, patients, clinicians, and policymakers. The framework puts the patient, and/or their caregiver at the center and illustrates how they are involved in all the following stages: Computable Clinical Knowledge, Patient-specific Inference, Information Delivery, Clinical Decision, Patient Behaviors, Health Outcomes, Aggregate Data, and patient-centered outcomes research (PCOR) Evidence. Using this idealized framework reminds key stakeholders that developing, deploying, and evaluating PC-CDS is a complex, sociotechnical challenge that requires consideration of all 8 stages. In addition, we need to ensure that patients, their caregivers, and the clinicians caring for them are explicitly involved at each stage to help us achieve the quintuple aim.

Using Evidence to Decision (EtD) frameworks to contextualise clinical practice guideline recommendations

Using Evidence to Decision (EtD) frameworks to contextualise clinical practice guideline recommendations

Co‐designing a toolkit for evidence‐based decision making in conservation: Processes and lessons

Abstract Improving the effectiveness of conservation practice requires better use of evidence. Since 2004, researchers from the Conservation Evidence group (University of Cambridge) have engaged with over 1100 named practitioners, policymakers, funders and other academics from across the world to identify needs and develop a range of principles, tools and resources to embed evidence in decision making. The goal of this engagement (the Conservation Evidence Programme) was to deliver improved conservation practice leading to benefits for nature and society. Together, we developed a theory of change with five key strategies for delivering change, alongside a freely available Evidence Toolkit to support decision makers in achieving that change. The authors describe the toolkit, a collection of freely available tools and resources developed by the collaborative programme, and how co‐design, employing different levels of partner engagement, enabled its development. Reflecting on our experiences highlighted a number of insights and recommendations, including the need to identify where deep engagement is a necessary condition for success; the importance of collective agreement of the roles of different partners; the need to consider how to facilitate uptake of new tools or practices, particularly where that requires changes to organisational practices or culture; and the importance of establishing processes/channels for ongoing engagement with stakeholders, with a willingness to be flexible and open to incorporating new suggestions and perspectives as needed. The Conservation Evidence Programme has enabled practitioners, funders and policymakers to become part of a network of forward‐thinking organisations that is working collaboratively to help drive more effective conservation practice through improved evidence use.

Featureless transmission spectra of 12 giant exoplanets observed by GTC/OSIRIS

Context. Exoplanet atmospheres are the key to understanding the nature of exoplanets. To this end, transit spectrophotometry provides us opportunities to investigate the physical properties and chemical compositions of exoplanet atmospheres. Aims. We aim to detect potential atmospheric signatures in 12 gaseous giant exoplanets using transit spectrophotometry and we try to constrain their atmospheric properties. Methods. The targets of interest were observed using transit spectrophotometry with the GTC OSIRIS instrument. We estimated the transit parameters and obtained the optical transmission spectra of the target planets using a Bayesian framework. We analyzed the spectral features in the transmission spectra based on atmospheric retrievals. Results. Most of the observed transmission spectra were found to be featureless, with only the spectrum of CoRoT-1b showing strong evidence for atmospheric features. However, in combination with the previously published near-infrared transmission spectrum, we found multiple interpretations for the atmosphere of CoRoT-1b due to the lack of decisive evidence for alkali metals or optical absorbers. Conclusions. Featureless spectra are not necessarily indicative of cloudy atmospheres if they poorly constrain the altitudes of cloud decks. Precise constraints on the models of hazes and clouds strongly depend on the significance of the observed spectral features. Further investigations on these exoplanets, especially CoRoT-1b, are required to confirm the properties of their atmospheres.

Approaches to monitoring and evaluation of knowledge translation platforms in low- and middle-income countries: A scoping review

Background: Knowledge Translation Platforms (KTP) attempt to bridge the "know-do gap" between researchers and policymakers. This study summarized the evidence on activities, as well as methods of monitoring and evaluation projects of KTPs in Low- and Middle-Income Countries (LMICs). Methods: The Arksey and O’Malley methodology for scoping reviews was used. The databases accessed include Medline, Global Health, CINAHL, EBSCO and Cochrane library databases. Only Studies that indicated range of activities, tools or methods used in monitoring and evaluating KTP to achieve the implementation of evidence informed policymaking in LMICs were included. The key words used includes Knowledge Translation, Monitoring and Evaluation, Platforms and Low- and Middle-Income countries. Results: Total of 3150 hits were obtained from the searched databases. 750 duplicates were identified and removed resulting to 2398 articles. Using title screening, 2123 articles were excluded resulting in 275 articles for abstract screening. Abstract screening led to exclusion 246 articles, leaving 29 articles for the full-text screening. Full-text screening resulted to exclusion of 25 articles resulting to 4 articles that meet the inclusion criteria. No relevant articles were obtained from the reference list screening and grey literature search. Conclusion: Evidence shows that Case study methodology is the predominate method of evaluating KTPs. The shortest time duration from generation to use of evidence in decision making was noticed to be 1-year. The range of activities used to monitor KTP in bridging the “know do gap” includes stakeholder’s engagement, building capacity, priority setting, meeting with stakeholders, generating policy brief, litmus testing of brief, stakeholders dialogue, evidence brief and dialogue review, disseminating of findings and implementation. The minimum and maximum number of activities performed in each KTP process is 5 and 8 activities respectively.

The Assessment of Ethical Leadership in Developing Ethical Climate and Decision Making-Evidence from Pakistan

Objective: The purpose of this research was to ascertain how ethical leadership influenced decision making through mediating role of ethical climate. Methodology: The current study was based upon the single reality that is have used the positivist approach to examine the relationship of the variables. In the quantitative method of the research study different methods are applied to test the hypothesis. This study has used the cross sectional time horizon in which the data have been collected from the respondents of the Pakistani public organizations in single/one point in time. Data were collected from the respondents with the help of the survey questionnaire among 200 respondents where the researcher got 150 responses from the respondents. Non probability sampling technique was applied in the research study. All the ethical procedures and guidelines were followed while collecting the data from the respondents. Results: Shown that ethical leadership has positive influence on ethical climate and decision making, ethical climate positively moderates the influence of ethical leadership on decision making. Conclusion: Controlling the ethical aspects in leadership effectively boosts decision making through the role of ethical climate.

Bridging Knowledge Gaps towards 2030: The Use of Foresight for the Strategic Management of a Sustainable Blue Economy

There is need to better understand the trends and future challenges influencing the marine and coastal environments and identify the opportunities to develop innovative sustainability-oriented solutions to address these. Alongside mainstream decision support tools used in environmental management and conservation sciences, foresight techniques provide comprehensive and well-rounded information and knowledge about likely developments in the long-term future. This study uses a horizon scanning exercise to explore emerging signals and trends of future developments and innovation for the sustainable development of the blue economy looking towards 2030. It derives a series of global developments, challenges and opportunities relating to the blue economy from a review of high-level international reports and studies. Through a workshop conducted with 29 scientists and researchers based in maritime universities in six countries in Europe, the study identifies and prioritizes emerging signals and trends considered of high impact for a sustainability transition. The outputs include a synthesis of 11 global developments in the blue economy and 7 cross-cutting trends and trend projections. These may be valuable to marine scientists as a source of inspiration for a future research agenda or can be used as evidence for decision- and policymakers to deal with future uncertainties about the growth of the blue economy.