Methodological Considerations Research Articles

A comprehensive review on role of magnetic resonance imaging in the precise measurement of corpus callosum

Magnetic Resonance Imaging (MRI) has emerged as a powerful and non-invasive imaging technique, playing a pivotal role in neuroimaging research and clinical diagnosis. This comprehensive review explores the significance of MRI in the precise measurement of the corpus callosum, a key structure connecting the two hemispheres of the brain. The corpus callosum plays a crucial role in inter hemispheric communication and is implicated in various neurological and psychiatric disorders. The review begins by elucidating the anatomy and functions of the corpus callosum, emphasizing its importance in facilitating seamless communication between the cerebral hemispheres. Subsequently, the paper delves into the historical evolution of MRI techniques and how advancements have enhanced the visualization and measurement capabilities of the corpus callosum. A detailed examination of various MRI modalities, including structural MRI, diffusion tensor imaging (DTI), and functional MRI, is presented in the context of corpus callosum analysis. Structural MRI provides high-resolution images for accurate morphological assessments, while DTI offers insights into white matter microstructure and fiber tractography, allowing for a more comprehensive understanding of the corpus callosum's integrity. The review also highlights the role of MRI in investigating alterations in the corpus callosum associated with neurological disorders such as multiple sclerosis, epilepsy, and neurodevelopmental disorders. Additionally, the paper explores how functional MRI contributes to understanding the functional connectivity and inter hemispheric interactions mediated by the corpus callosum. Challenges and limitations in the measurement of the corpus callosum using MRI are discussed, including methodological considerations, image artifacts, and potential sources of variability. The review concludes by outlining future directions in corpus callosum imaging research, including the integration of advanced imaging techniques, artificial intelligence, and large-scale multi-center studies to enhance the precision and reliability of measurements.In summary, this comprehensive review underscores the pivotal role of MRI in advancing our understanding of the corpus callosum, providing valuable insights into both normal brain function and pathological conditions. The continual evolution of MRI techniques holds promise for further refining the assessment of the corpus callosum, ultimately contributing to improved diagnostic accuracy and therapeutic interventions in neurological and psychiatric disorders.

Developing conceptual framework and methodological considerations in community-supported chronic disease management

Developing conceptual framework and methodological considerations in community-supported chronic disease management

Wearable laser Doppler flowmetry for non-invasive assessment of diabetic foot microcirculation: methodological considerations and clinical implications.

Type 2 diabetes mellitus (T2DM) is a global health concern with significant implications for vascular health. The current evaluation methods cannot achieve effective, portable, and quantitative evaluation of foot microcirculation. We aim to use a wearable device laser Doppler flowmetry (LDF) to evaluate the foot microcirculation of T2DM patients at rest. Eleven T2DM patients and twelve healthy subjects participated in this study. The wearable LDF was used to measure the blood flows (BFs) for regions of the first metatarsal head (M1), fifth metatarsal head (M5), heel, and dorsal foot. Typical wavelet analysis was used to decompose the five individual control mechanisms: endothelial, neurogenic, myogenic, respiratory, and heart components. The mean BF and sample entropy (SE) were calculated, and the differences between diabetic patients and healthy adults and among the four regions were compared. Diabetic patients showed significantly reduced mean BF in the neurogenic () and heart () components at the M1 and M5 regions () compared with healthy adults. Diabetic patients had significantly lower SE in the neurogenic () and myogenic () components at the M1 region, as well as in the endothelial () component at the M5 region and in the myogenic component at the dorsal foot (), compared with healthy adults. The SE in the myogenic component at the dorsal foot was lower than at the M5 region () and heel area (). Similarly, the SE in the heart component at the dorsal foot was lower than at the M5 region () and heel area () in diabetic patients. This study indicated the potential of using the novel wearable LDF device for tracking vascular complications and implementing targeted interventions in T2DM patients.

Methodological Considerations Regarding the Quantification of DNA Impurities in the COVID-19 mRNA Vaccine Comirnaty®

DNA impurities can impact the safety of genetically engineered pharmaceuticals; thus, a specific limit value must be set for them during marketing authorisation. This particularly applies to mRNA vaccines, as large quantities of DNA templates are used for their production. Furthermore, when quantifying the total DNA content in the final product, we must observe that, in addition to the mRNA active ingredient, DNA impurities are also encased in lipid nanoparticles and are therefore difficult to quantify. In fact, the manufacturer of the mRNA vaccine Comirnaty (BioNTech/Pfizer) only measures DNA impurities in the active substance by means of a quantitative polymerase chain reaction (qPCR), whose DNA target sequence is less than just 1% of the originally added DNA template. This means that no direct DNA quantification takes place, and compliance with the limit value for DNA contamination is only estimated from the qPCR data using mathematical extrapolation methods. However, it is also possible to dissolve the lipid nanoparticles with a detergent to directly measure DNA contamination in the final product by using fluorescence spectroscopic methods. Experimental testing of this approach confirms that reliable values can be obtained in this way.

Artificial intelligence in epilepsy - applications and pathways to the clinic.

Artificial intelligence (AI) is rapidly transforming health care, and its applications in epilepsy have increased exponentially over the past decade. Integration of AI into epilepsy management promises to revolutionize the diagnosis and treatment of this complex disorder. However, translation of AI into neurology clinical practice has not yet been successful, emphasizing the need to consider progress to date and assess challenges and limitations of AI. In this Review, we provide an overview of AI applications that have been developed in epilepsy using a variety of data modalities: neuroimaging, electroencephalography, electronic health records, medical devices and multimodal data integration. For each, we consider potential applications, including seizure detection and prediction, seizure lateralization, localization of the seizure-onset zone and assessment for surgical or neurostimulation interventions, and review the performance of AI tools developed to date. We also discuss methodological considerations and challenges that must be addressed to successfully integrate AI into clinical practice. Our goal is to provide an overview of the current state of the field and provide guidance for leveraging AI in future to improve management of epilepsy.

Customer-Perceived Innovation: Considerations for Financial Performance and Methodological Approaches

As firms increasingly uncover their activities to key stakeholders through various media, the perception of these activities is becoming more important for firm performance. Traditionally, access to industry-wide databases provides important metrics on customer perceptions of performance, such as customer satisfaction and brand equity. In addition, numerous studies have highlighted firms' innovation-related actions (e.g., R&D spending and patent counts) as critical metrics linked to their financial performance. Perceived Firm Innovation (PFI) emerges as a relatively new and under-studied metric with the potential to impact a firm's financial success. Keiningham et al. are among the pioneers in this area. This commentary views their article as a vital initial step in understanding PFI’s impact. Considering that the service sector accounts for over 70 percent of the GDP in any developed country, service innovation is a broad phenomenon. Given the breadth of the area, we point to the challenge of capturing this phenomenon with a single metric like PFI. We also discuss crucial methodological considerations for future research, including estimation methods, sample size, and financial metrics.

Physical Exercise to Redynamize Interoception in Substance use Disorders.

Physical exercise is considered a promising medication-free and cost-effective adjunct treatment for substance use disorders (SUD). Nevertheless, evidence regarding the effectiveness of these interventions is currently limited, thereby signaling the need to better understand the mechanisms underlying their impact on SUD, in order to reframe and optimize them. Here we advance that physical exercise could be re-conceptualized as an "interoception booster", namely as a way to help people with SUD to better decode and interpret bodily-related signals associated with transient states of homeostatic imbalances that usually trigger consumption. We first discuss how mismatches between current and desired bodily states influence the formation of reward-seeking states in SUD, in light of the insular cortex brain networks. Next, we detail effort perception during physical exercise and discuss how it can be used as a relevant framework for re-dynamizing interoception in SUD. We conclude by providing perspectives and methodological considerations for applying the proposed approach to mixed-design neurocognitive research on SUD.

Research and practice priorities in pilonidal sinus disease: a consensus from the PITSTOP study.

Pilonidal sinus disease is a common condition treated by colorectal surgeons. There is a lack of literature in the field to guide optimal management of this condition. As part of the PITSTOP study, we aimed to identify policy and research priorities to provide direction to the field. Patients and surgeons were invited to participate. A 'So what, now what' exercise was conducted, informed by data from PITSTOP. This generated statements for research and practice priorities. A three-round online Delphi study was conducted, ranking statements based on policy and research separately. Statements were rated 1 (not important) to 9 (important). Statements that were rated 7-9 by more than 70% of participants were entered into the consensus meeting. Personalized voting feedback was shown between rounds. A face-to-face meeting was held to discuss statements, and participants were asked to rank statements using a weighted choice vote. Twenty-two people participated in the focus group, generating 14 research and 19 policy statements. Statements were voted on by 56 participants in round 1, 53 in round 2 and 51 in round 3. A total of 15 policy statements and 19 research statements were discussed in the consensus round. Key policy statements addressed treatment strategies and intensity, surgeon training opportunities, need for classification and the impact of treatment on return to work. Research recommendations included design of future trials, methodology considerations and research questions. This study has identified research and policy priorities in pilonidal sinus disease which are relevant to patients and clinicians. These should inform practice and future research.

Population and Target Population in Research Methodology

This paper thoroughly explores the foundational principles governing population and target population concepts within research methodology. It delves into the essential roles these concepts play in shaping the design and influencing the interpretation of research studies. Through an exhaustive analysis, it meticulously outlines the nuances that differentiate these two concepts, elucidating their respective contributions and implications across diverse research paradigms. Moreover, this paper underscores the importance of establishing clear definitions and boundaries for both the population and the target population. It emphasises how such precision is indispensable in guiding the formulation of effective sampling strategies, which are pivotal for ensuring the accuracy and reliability of study outcomes. Furthermore, it sheds light on how the clarity in defining these concepts significantly impacts the generalizability of research findings, elucidating how findings derived from a well-defined target population can be more confidently extrapolated to broader populations. In addition to methodological considerations, this paper investigates the ethical dimensions inherent in delineating population and target population. It underscores the moral imperative of accurately representing the groups under study, particularly ensuring equitable access to research participation and safeguarding against potential biases.

Qualche nota e interrogativo intorno a nuove prospettive di ricerca sul magistero romano a metà Novecento

This paper proposes some considerations through a cross-reading of the articles published in this issue. The new research reveals several protagonists of the curial environment in the elaboration of Pius XII’s magisterial documents: the consultors at the Holy Office Franz Hürth, Sebastiaan Tromp, the better-known Augustin Bea; the secretary of Briefs to Princes Antonio Bacci. The role of the Society of Jesus is also relevant: it is able to mitigate or deflect curial proceedings initiated against its members. The articles add important contributions to our knowledge of Pius XII’s modus operandi at the head of the Catholic Church, with the support of his main collaborators (Montini, Dell’Acqua) and in the context of the internal dialectics within the Holy See. At the doctrinal level, the question of modernism and its new expressions appeared central throughout Pacelli’s pontificate. The text also offers some methodological considerations regarding contemporary research in the field of the history of Christianity and the Churches.

Prevalence of chronic kidney disease in France: methodological considerations and pitfalls with the use of Health claims databases

Abstract Background Health policy-making require careful assessment of CKD epidemiology to develop efficient and cost-effective care strategies. The aim of the present study was to use the RENALGO-EXPERT algorithm to estimate the global prevalence of CKD in France. Methods An expert group developed the RENALGO-EXPERT algorithm based on healthcare consumption. This algorithm has been applied to the French National Health claims database (SNDS), where no biological test findings are available in order to estimate a national CKD prevalence for the years 2018–2021. The CONSTANCES cohort (+ 219 000 adults aged 18–69 with one CKD-EPI eGFR) was used to discuss the limit of using health claims data. Results Between 2018 and 2021, the estimated prevalence in the SNDS increased from 8.1% to 10.5%. The RENALGO-EXPERT algorithm identified 4.5% of the volunteers in the CONSTANCES as CKD. The RENALGO-EXPERT algorithm had a PPV of 6.2% and NPV of 99.1% to detect an eGFR<60 ml/min/1.73m². Half of 252 false positive cases (ALGO +, eGFR > 90) had been diagnosed with kidney disease during hospitalization, and the other half based on healthcare consumption suggestive of a ‘high-risk’ profile. 95% of the 1661 false negatives (ALGO -, eGFR < 60) had an eGFR between 45 and 60 ml/min, ½ had medication and 2/3 a biological exams possibly linked to CKD. Half of them had a hospital stay during the period but none had a diagnosis of kidney disease. Conclusions Our result is in accordance with other estimations of CKD prevalence in the general population. Analysis of diverging cases (FP and FN) suggests using health claims data has inherent limitations. Such algorithm is able to identify patients whose care pathway is close to the usual and specific CKD pathways. It does not identify patients who have not been diagnosed or whose care is inappropriate or at early stage with stable GFR.

Postdigital ethnography in applied linguistics: Beyond the online and offline in language learning

We live in a postdigital world where traversing digital and in-person domains for teaching and learning is normalized, raising important methodological and ethical considerations for ethnographic approaches in language education. We define postdigital as a condition where the virtual and physical mediate each other to form hybrid spaces that transcend the online/offline distinction. We begin the article with theoretical discussions on the epistemological orientations that inform postdigital inquiry. Then we situate our language education research, discussing the value of ethnography for understanding hybrid spaces and identifying the challenges and limitations of existing ethnographic methodologies in addressing postdigital conditions. Following this, we illustrate ways to follow the chosen unit of analysis in postidigital ethnography through three case studies, specifically focusing on pedagogical activities. We also reflect on pedagogical insights from postdigital ethnography, sensitive ethical concerns involved in postdigital research, as well as considerations for addressing those ethical issues. We conclude the paper with practical suggestions for researchers on conducting postdigital ethnographies.

Application of causal inference methods in individual-participant data meta-analyses in medicine: addressing data handling and reporting gaps with new proposed reporting guidelines

Observational data provide invaluable real-world information in medicine, but certain methodological considerations are required to derive causal estimates. In this systematic review, we evaluated the methodology and reporting quality of individual-level patient data meta-analyses (IPD-MAs) conducted with non-randomized exposures, published in 2009, 2014, and 2019 that sought to estimate a causal relationship in medicine. We screened over 16,000 titles and abstracts, reviewed 45 full-text articles out of the 167 deemed potentially eligible, and included 29 into the analysis. Unfortunately, we found that causal methodologies were rarely implemented, and reporting was generally poor across studies. Specifically, only three of the 29 articles used quasi-experimental methods, and no study used G-methods to adjust for time-varying confounding. To address these issues, we propose stronger collaborations between physicians and methodologists to ensure that causal methodologies are properly implemented in IPD-MAs. In addition, we put forward a suggested checklist of reporting guidelines for IPD-MAs that utilize causal methods. This checklist could improve reporting thereby potentially enhancing the quality and trustworthiness of IPD-MAs, which can be considered one of the most valuable sources of evidence for health policy.

Facebook recruitment: understanding research relations Prior to data collection

ABSTRACT This article considers the multiple relations that emerge from and between Facebook commenters, as well as between commenters, researchers, and the research project during recruitment. To do so, we draw on our experiences of recruiting individuals who have concerns about or are opposed to a range of recent social and legal changes in ‘post-equality’ contexts. Understanding research as co-created rather than ‘collecting data from’ participants, we consider the researcher, commenters, and Facebook technologies as active agents, and ask how the emergent relationalities between these agents shapes the social media recruitment process. We develop thinking regarding these relationalities through an in-depth exploration of our processes that reveal key methodological considerations relevant to social media recruitment in the social sciences. As the process of recruitment is mutually constructed online through multiple relationalities across researcher/project and commenter, as well as between commenters themselves, we conclude that there is a need for dynamic, iterative, and reflexive responses and engagements rather than pre-defined frameworks.

Sharing interview questions in advance: Methodological considerations in applied linguistics research

Abstract Interviews serve as a prominent methodological tool in applied linguistics and beyond, allowing researchers to explore participants’ experiences, ideologies and beliefs. Yet, the extent to which interview questions are shared in advance with participants is often unclear, although this methodological decision can substantially shape responses and subsequent reflections. Some advantages of sharing interview questions in advance include enhanced participant engagement and reflexivity, reduced interview anxiety, and more thoughtful responses. Conversely, the practice may engender risks such as participant bias, and predetermined answers. This reflective piece addresses this underexplored aspect by first discussing methodological considerations of such a practice, including a brief review of existing practices in research on language teacher ideologies and beliefs. Second, it considers ethical dimensions entailed in such a practice. Additionally, this paper explores how six English teachers in Norway experienced having access to all interview questions in advance to prepare for interviews centred around their individual teaching beliefs about multilingualism and multilingual practices. The paper concludes by suggesting that sharing interview questions in advance can benefit both participants and enhance the quality of research.

Advancing Pediatric Sarcomas through Radiomics: A Systematic Review and Prospective Assessment Using Radiomics Quality Score (RQS) and Methodological Radiomics Score (METRICS).

Pediatric sarcomas, rare malignancies of mesenchymal origin, pose diagnostic and therapeutic challenges. In this review, we explore the role of radiomics in reshaping our understanding of pediatric sarcomas, emphasizing methodological considerations and applications such as diagnostics and predictive modeling. A systematic review conducted up to November 2023 identified 72 papers on radiomics analysis in pediatric sarcoma from PubMed/MEDLINE, Web of Knowledge, and Scopus. Following inclusion and exclusion criteria, 10 reports were included in this review. The studies, predominantly retrospective, focus on Ewing sarcoma and osteosarcoma, utilizing diverse imaging modalities, including CT, MRI, PET/CT, and PET/MRI. Manual segmentation is common, with a median of 35 features extracted. Radiomics Quality Score (RQS) and Methodological Radiomics Score (METRICS) assessments reveal a consistent emphasis on non-radiomic features, validation criteria, and improved methodological rigor in recent publications. Diagnostic applications dominate, with innovative studies exploring prognostic and treatment response aspects. Challenges include feature heterogeneity and sample size variations. The evolving landscape underscores the need for standardized methodologies. Despite challenges, the diagnostic and predictive potential of radiomics in pediatric oncology is evident, paving the way for precision medicine advancements.

Developing internet-based Tests of Aptitude for Language Learning (TALL): An open research endeavour

Tests of Aptitude for Language Learning (TALL) is an openly accessible internet-based battery to measure the multifaceted construct of foreign language aptitude, using language domain–specific instruments and L1-sensitive instructions and stimuli. This brief report introduces the components of this theory-informed battery and methodological considerations for developing it into an open research instrument. It also presents the preliminary results from the initial validation of TALL carried out on data collected from Chinese L1 participants ( n = 165) from a university setting who took two rounds of tests (with counterbalanced test items) with a minimum 30-day interval. The results of data analyses at subtest, item, and battery levels suggest that, in general, TALL has satisfactory reliability and can be used to measure aptitude conceptualized in the theoretical frameworks on which it has been developed. This report also highlights the value of TALL as a convenient data collection tool openly accessible to any researcher for free, its potential for facilitating an open data pool for high-quality syntheses of aptitude-related research findings, and its implications for Open Research practices in testing language-related constructs.

Experimental approach to development economics: a review of issues and options

ABSTRACT Randomized control trials (RCTs) are recognized as the preferred tool of analysis in modern development economics literature/research and policy evaluation. This may lead to methodologies, including case studies, tabular analysis, simple regressions, taking a back seat. This survey explores the implications of such a methodological hierarchy and the implications of preoccupation with a particular evidence/methodology for research and policy. Similar developments in macroeconomic modelling are also discussed. Major advantages and limitations of RCTs and the attempts to address them are highlighted. The article argues that preoccupation with a methodology can sometimes lead to important inquiries for research and policy getting side-lined on methodological considerations. This leads to inferences favouring a particular technique/methodology or issue. Focusing solely on methodologies that emphasize quantifying the ‘effect’ may not be appropriate to address all questions relevant to development. As policies involve multiple and conflicting social concerns, methodological pluralism may be preferable.

From taboo to treatment: The emergence of psychedelics in the management of pain and opioid use disorder

The rise of psychedelics in contemporary medicine has sparked interest in their potential therapeutic applications. While traditionally associated with countercultural movements and recreational use, recent research has shed light on the potential benefits of psychedelics in various mental health conditions. In this review, we explore the possible role of psychedelics in the management of chronic pain and opioid use disorder (OUD), 2 critical areas in need of innovative treatment options. Pain control remains a significant clinical challenge, particularly for individuals with OUD and those who receive long‐term opioid therapy who develop marked tolerance to opioid‐induced analgesia. Despite the magnitude of this problem, there is a scarcity of controlled studies investigating pain management alternatives for these populations. Drawing from preclinical and human evidence, we highlight the potential of psychedelics to act on shared neurobiological substrates of chronic pain and OUD, potentially reversing pain‐ and opioid‐induced neuroadaptations, such as central sensitization. We elaborate on the multifaceted dimensions of the pain experience (sensory, affective and cognitive) and their intersections that overlap with opioid‐related phenomena (opioid craving and withdrawal), hypothesizing how these processes can be modulated by psychedelics. After summarizing the available clinical research, we propose mechanistic insights and methodological considerations for the design of future translational studies and clinical trials, building on a shared clinical and neurobiological understanding of chronic pain and OUD. Our intention is to provide timely perspectives that accelerate the development and exploration of novel therapeutics for chronic pain and OUD amidst the escalating opioid crisis.

Steps to Prepare Bilingual Data for Analysis: A Methodological Approach

This methodological paper offers a five-step model for preparing bilingual data for analysis. The article is guided by research in translating bilingual data into qualitative research. A systematic analysis of the research studies was conducted to identify workable options for preparing bilingual data for analysis. The proposed five-step model is comprised of (1) translator’s worldview and professionalism, (2) epistemological, ontological, and methodological considerations, (3) line of translation, (4) responsiveness to cultural terms and (5) eagerness to trustworthiness and reliability of the data. Researcher’s worldviews encompass the visibility of translator’s positionality for reflexivity, avoidance of biasness, and demonstration of professionalism. The bilingual data needs treatment based on epistemological, ontological, and methodological orientations which the translators need to be mindful of. The researcher must be clear on the line of translation in opting for direct translation, back-translation, single translation, or multiple translations. The translated data must be responsive to the cultural contexts to carry on sense and meaning. Depending on the methodological approaches and contextual requirements, the translation work must meet the needs of trustworthiness and validity. The literature is silent on the translations of non-verbal cues. Therefore, this problem should be dealt with separately in future research endeavors. Similarly, future research on linguistic contexts and translation work in diverse research approaches such as quantitative, qualitative, and mixed methods is needed.