Stages Of Research Design Research Articles

Embracing innovation: A patient advocacy perspective on evolving trial designs

SMA Schweiz and SMA Europe, two patient advocacy organisations for the rare condition spinal muscular atrophy (SMA), work towards promoting the fastest possible access to safe and effective medicines for all individuals who can benefit from them. Their experience has shown that patient and public involvement at the design stage of clinical research directly impacts a product’s pathway to patients and leads to a better understanding of a product’s value later on. Furthermore, recent discussions about how complex clinical trial designs and decentralised clinical trials use innovative methods to conduct clinical research indicate their potential to make trials more flexible, personalised, and convenient for participants. In addition to helping shift current paradigms, innovative trial designs hold enormous potential to further advance medicines for the good of patient communities, especially in the area of rare diseases.

Involving children and young people in supportive cancer care research: the value of FDS grant funding and charitable partnerships

INTRODUCTION Involvement of children and young people in research has a multitude of benefits for children, researchers and the quality of the research itself. Despite the benefits of involvement, this is not always completed or reported in practice. METHODS This paper looks at the involvement of children and young people during a research study exploring the acceptability of photobiomodulation for mucositis management. It considers the importance of costing involvement into grant funding, and the value of charitable partnerships in conducting research with patient and public involvement. RESULTS Children and young people with experience of cancer, and their parents, were involved at the stages of grant application, research design, data analysis and dissemination. Involvement of families resulted in changes to inclusion criteria, plain language summaries and participant information documents. They provided insight into data analysis, and designed and filmed co-created video outputs to support acceptability of the treatment, dissemination of the research and research involvement of other children. Involvement was supported both practically and financially by charitable partnership with the Candlelighters children’s cancer charity as well as research grant funding from the Royal College of Surgeons of England’s Faculty of Dental Surgery. CONCLUSIONS Child and parent contributors shaped the research project, resulting in changes to the study design, data analysis and co-creation of video resources. Charitable partnership and flexibility of involvement supported diversity in the context of paediatric cancer research. Researchers should consider what they can contribute in return to child contributors and charities who provide support.

Research Ethics and International and Cross-Cultural Research: Fiji and Aotearoa New Zealand

ABSTRACT There are significant challenges associated with conducting research with a researcher from another institution, in another country or with another culture, and even more challenges when all three factors apply. This paper critically appraises the complexities of a cross-cultural, international and collaborative research project, and identifies the challenges for the researchers and their organisations, and the ways in which these were managed. It evaluates the process of obtaining ethics approval from two organisations in Aotearoa New Zealand and Fiji. This paper presents the perspectives of both the researchers and the organisations providing ethics approval. There is often concern that research conducted by someone from a ‘global north’ country (here, Aotearoa New Zealand) in a ‘global south’ country (here, Fiji) will have power asymmetries, and that research will disadvantage the researched community, or not provide any benefit back to them; this project directly addressed these concerns. The research outputs, and research outcomes and impact, need to be considered at the research design stage to ensure they are appropriate for the community in which the research is being conducted. While organisations may be reluctant to approve research conducted in a different culture and country, the risks can be managed and mitigated.

Alternatives to the P value: connotations of significance.

The statistical significance of a clinical trial analysis result is determined by a mathematical calculation and probability based on null hypothesis significance testing. However, statistical significance does not always align with meaningful clinical effects; thus, assigning clinical relevance to statistical significance is unreasonable. A statistical result incorporating a clinically meaningful difference is a better approach to present statistical significance. Thus, the minimal clinically important difference (MCID), which requires integrating minimum clinically relevant changes from the early stages of research design, has been introduced. As a follow-up to the previous statistical round article on P values, confidence intervals, and effect sizes, in this article, we present hands-on examples of MCID and various effect sizes and discuss the terms statistical significance and clinical relevance, including cautions regarding their use.

T-wave morphology abnormalities in the STREAM stage 1 trial

ABSTRACT Background Shorter regimens for drug-resistant tuberculosis (DR-TB) have non-inferior efficacy compared with longer regimens, but QT prolongation is a concern. T-wave morphology abnormalities may be a predictor of QT prolongation. Research design and methods STREAM Stage 1 was a randomized controlled trial in rifampicin-resistant TB, comparing short and long regimens. All participants had regular ECGs. QT/QTcF prolongation (≥500 ms or increase in ≥60 ms from baseline) was more common on the short regimen which contained high-dose moxifloxacin and clofazimine. Blinded ECGs were selected from the baseline, early (weeks 1–4), and late (weeks 12–36) time points. T-wave morphology was categorized as normal or abnormal (notched, asymmetric, flat-wave, flat peak, or broad). Differences between groups were assessed using Chi-Square tests (paired/unpaired, as appropriate). Results Two-hundred participants with available ECGs at relevant times were analyzed (QT prolongation group n = 82; non-prolongation group n = 118). At baseline, 23% (45/200) of participants displayed abnormal T-waves, increasing to 45% (90/200, p < 0.001) at the late time point. Abnormalities were more common in participants allocated the Short regimen (75/117, 64%) than the Long (14/38, 36.8%, p = 0.003); these occurred prior to QT/QTcF ≥500 ms in 53% of the participants (Long 2/5; Short 14/25). Conclusions T-wave abnormalities may help identify patients at risk of QT prolongation on DR-TB treatment. Trial Registration The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT02409290). Current Controlled Trial number, ISRCTN78372190

DEVELOPMENT OF ACHIEVEMENT MOTIVATION TRAINING MODULE TO IMPROVE STUDENT ACADEMIC RESILIENCE IN DISASTER AREAS

Students living in disaster-prone areas often experience obstacles to increasing enthusiasm for learning and a lack of resilience, especially academic resilience. This research aims to develop an Achievement Motivation training module to improve Student Academic Resilience. This research was conducted with a 4D model research and development model consisting of 4 stages, namely define, design, develop, and disseminate. The respondents were disaster-prone students in Central Sulawesi. The data analysis technique used is the first quantitative descriptive of the problem profile of students' academic resilience. Second, qualitative descriptive data analysis was used for FGD result analysis to design achievement motivation training models. The results of the define stage research found student problems related to academic resilience. Descriptive analysis finds aspects of academic resilience, namely problem-facing ability, self-adjustment, resilience, and problem-solving ability. The results of the research design stage have formulated an Achievement motivation Training module for disaster-prone students. The study recommends the primary role of teachers in helping students achieve higher levels of academic resilience. One of the recommended programs is achievement motivation training, which can be adopted by teachers through classical and group approaches.

People and places: towards an understanding and categorisation of reasons for place attachment – case studies from the north of England

People develop a sense of place, belonging and identity when a place affords tangible and intangible benefits like security, familiarity, shelter, food, work opportunities, and social interaction. Places form landscapes individually valued by people for these reasons. This paper describes Topic Modelling as a new grounded approach to assessing people’s sense of place in a rural landscape affording special qualities for everyday working and living situations – the Peak District National Park, UK. This novel approach is applicable and scalable to any landscape, rural or urban, iconic, or everyday. Results of this study show that significant themes and phenomena not hypothesised at the initial research design stage can emerge from interview data. Examples include pro-environmental behaviours resulting from traditional farming practices, environmental benefits of the drystone-walling tradition, and attitudes towards rewilding initiatives. We argue that such phenomena arise from people’s attachment to place and influence their behaviours.

Trust, pandemic and communication: an analysis of the COVID-19 pandemic from an autopoietic systems perspective

PurposeThis article seeks to discuss trust within the context of public health crises using an autopoietic systems perspective that positions communication as one of its core concepts. This article will explore trust studies conducted during public health crises in this Millennium (from SARS to COVID-19 pandemics), including their problems; briefly summarize Luhmann's concept of Vertrauen; and use this concept to analyze trust issues during the COVID-19 pandemic.Design/methodology/approachThis article will explore trust studies conducted during public health crises from SARS to COVID-19 pandemics, including their problems. The perspective used is an explication of Niklas Luhmann's theory regarding Vertrauen which was derived as a framework for reading empirical facts on trust issues during the COVID-19 pandemic. The research design and exploration stages were inspired by the theory of autopoiesis systems by Niklas Luhmann.FindingsFrom a systems perspective, the COVID-19 pandemic has highlighted the extraordinary complexity of the linkages between social systems. Trust will continue to evolve dynamically as new variants emerge in society. Consequently, the pandemic has provided the momentum necessary for maximally exploring the concept of trust. Indonesia thus experienced significant obstacles when making and implementing disaster mitigation policies. Owing to the lack of a trust system, greater emphasis was given to control and power. There has been little preparedness to create and reinforce public trust, and this in turn has stifled efforts to stop the spread of COVID-19.Originality/valueThis study of trust, communication and public health crises has provided space to reflect on the development of trust within the social system. This study shows that trust can prove to be a very important factor in resolving a crisis. However, the complexity of the interrelationships of the social system can affect the quality of trust. The context of Indonesia's social system which is very complex due to population density and the dynamics of the development of its social system which is very diverse as an archipelagic country has contributed to the originality of the study of trust in times of crisis in a growing contemporary society.

Prevalence, drivers and surveillance of antibiotic resistance and antibiotic use in rural China: Interdisciplinary study.

This study aimed to characterise antibiotic prescribing and dispensing patterns in rural health facilities in China and determine the community prevalence of antibiotic resistance. We investigated patterns and drivers of antibiotic use for common respiratory and urinary tract infections (RTI/UTI) in community settings, examined relationships between presenting symptoms, clinical diagnosis and microbiological results in rural outpatient clinics, and assessed potential for using patient records to monitor antibiotic use. This interdisciplinary mixed methods study included: (i) Observations and exit interviews in eight village clinics and township health centres and 15 retail pharmacies; (ii) Urine, throat swab and sputum samples from patients to identify potential pathogens and test susceptibility; (iii) 103 semi-structured interviews with doctors, patients, pharmacy workers and antibiotic-purchasing customers; (iv) Assessment of completeness and accuracy of electronic patient records through comparison with observational data. 87.9% of 1123 recruited clinic patients were prescribed antibiotics (of which 35.5% contained antibiotic combinations and >40% were for intravenous administration), most of whom had RTIs. Antibiotic prescribing for RTIs was not associated with presence of bacterial pathogens but was correlated with longer duration of infection (OR = 3.33) and presence of sore throat (OR = 1.64). Fever strongly predicted prescription of intravenous antibiotics (OR = 2.87). Resistance rates in bacterial pathogens isolated were low compared with national data. 25.8% of patients reported antibiotics use prior to their clinic visit, but only 56.2% of clinic patients and 53% of pharmacy customers could confirm their prescription or purchase included antibiotics. Diagnostic uncertainty, financial incentives, understanding of antibiotics as anti-inflammatory and limited doctor-patient communication were identified as key drivers of antibiotic use. Completion and accuracy of electronic patient records were highly variable. Prevalence of antibiotic resistance in this rural population is relatively low despite high levels of antibiotic prescribing and self-medication. More systematic use of e-records and in-service training could improve antibiotic surveillance and stewardship in rural facilities. Combining qualitative and observational anthropological methods and concepts with microbiological and epidemiological investigation of antibiotic resistance at both research design and analytic synthesis stages substantially increases the validity of research findings and their utility in informing future intervention development.

“A shared human endeavor”: farmer participation and knowledge co-production in agroecological research

Farmer participation in the co-production of knowledge has been claimed to have many benefits, including its capacity to address the knowledge intensiveness and ecological specificity that underpins agroecology. The complexity of agroecological knowledge systems have until now presented considerable challenges to researchers looking to develop research practices adaptable to and commensurate with the integrative ambition of agroecology. As with agroecology in general, participation in research cannot be delivered in a one-size-fits-all approach, with each case needing to be designed on the basis of numerous factors, especially including the needs, objectives, and capacities of diverse participants. This article presents a conceptual framework to explore farmer participation in the co-construction of knowledge in agroecology. Through an exploration of three UK-based participatory research projects we develop a framework to better understand the practical challenges and opportunities for deepening the co-construction of knowledge. Using a combination of field notes, interviews, and survey data, the article concludes by offering practical reflections on ways to co-design research based on the type of knowledge(s) produced, the types of participation envisaged, as well as the needs and capacities of the research participants themselves. The framework presented in the article is offered as a tool to guide early stages of research design in order to balance the complex and changing needs of researchers and their collaborators.

Optimalisasi Respons Surface Terhadap Profil Asam Tempe Lotus (Nelumbo nucifera) Rawa Perikanan

This study aimed to determine the best using of combination processes in the manufacture of lotus tempeh and determine the dominant acid profile in lotus seeds tempeh. This study was conducted with 2 stages of research design, the first stage was optimization of the best process in the manufacture of fermented lotus (lotus tempeh) using the Response Surface Methodology (RSM) box Behnken with data analysis by Minitab software version 19. In the second stage, the optimal data of the first stage analyzed by descriptive analysis of acid profile and alcohol content. Based on the measurement of acid content in lotus seed tempeh ranged from 4.33-20.5% for the best combination treatments (0.5 g starter, 24 h soaking time, and 36 h fermentation time), and the alcohol content in optimal tempeh obtained from 4.74% to 5.06%. The optimal lotus tempeh has 46 compounds in acid profile as tempeh flavour, wherein cyclobutanol and ethanol as the dominant compound in the acid profile.

The Use and Challenges of Spatial Data in Archaeology

OverviewSpatial data, under the broader umbrella of digital data, is becoming increasingly integral to all stages of archaeological research design and dissemination. As archaeologists lean toward reuse and interoperability, with ethics on their minds, how to treat spatial data is of particular importance. This is because of the complexities involved at every life-cycle stage, from collection to publication, including black box issues that may be taken for granted, and because the size of spatial data can lead to archiving difficulties. Here, the “DIY” momentum of increasingly accessible spatial methods such as photogrammetry and handheld lidar is examined alongside forthcoming changes in publication policies that will impact the United States in particular, framed around a conversation about best practices and a call for more comprehensive training for the archaeological community. At its heart, this special issue seeks to realize the potential of increasingly digitized—and increasingly large amounts of—archaeological data. Within cultural resource management, this means anticipating utilization of data through widespread standardization, among many interrelated activities. A desire to enhance the utility of archaeological data has distinct resonances with the use of spatial data in archaeology, as do some wider challenges that the archaeological community faces moving forward.

The Use of Bamboo Material as a Support Product Display for Urban Farming Communities in Tourism Village

‘Saung Bambu’ or Bamboo huts can be utilized as a unique display space facility for additional MSMEs’ product values. This paper discusses the optimal design concept to display featured products from urban farming local communities. The study case of local bamboo material as a display of the urban farming environment in Cibarani village also examined some values that can be highlighted through specific research stages (literature study, online observation, and online interviews) and design stages (design concept and final implementation). The result shows that the use of bamboo material in supporting product display can impact tourist attractions in Cibarani village which also enhances the economic value itself. The conclusion states that the use of bamboo as a marketing strategy indicates a positive value for social, economic, and environmental sustainability.

Media-based agility training model of badminton games for students of universitas negeri jakarta badminton club

Badminton athletes need agility to place the shuttlecock into an empty opponent's field so that the opponent finds it difficult to return the ball. So, the purpose of this study is to create an exercise model to improve agility in the badminton game. Making this model through five stages, namely analysis, design, development, implementation and evaluation with the type of development research and development from Robert Maribe Branch. The results of the developed model were validated by three experts in badminton. Based on the five stages of research (analysis, design, development, implementation and evaluation), the results obtained that the training model developed was feasible and could be applied to badminton club athletes at the State University of Jakarta. The conclusion of the research is the media-based agility training model of the badminton game can be applied to the training process that aims to improve the athlete's agility.

Mathematics Book Innovation Based on Digital Literature

The development of the era that makes the use of technology lively. Especially during the Covid-19 pandemic. All learning activities in schools are carried out online by utilizing various technologies. Therefore, a study was conducted with the aim of making a Mathematics Book based on Digital Literacy with multimedia assistance, namely Media Powtoon, Augmented Reality (AR) and the Kahoot application, in addition to seeing the feasibility of the book, the attractiveness of the book and the effectiveness of using Mathematics Books based on Digital Literacy in learning in high school N 1 Stabat. The research method used in this research is the development of the ADDIE model which has five stages of research implementation, namely Analysis, Design, Develop, Implement, and Evaluate. The result of this research has been the development of a digital-based Mathematics book with the title Geometry for SMA. This digital book has been through validation and testing. math book. In terms of feasibility, attractiveness and effectiveness. From the results of the validation to the two validators, it was obtained an assessment of "very feasible" meaning that digital books can be used and the results of the trial show that digital books are very interesting with the criteria of "Very Interesting" and are effective as seen from the results of the posttest calculations, digital books are very effective in increasing the score students who learn to use a digital book with the title Geometry for this high school.

The Development of Digital Books Aided Augmented Reality (AR) to Improve Self Efficacy in Favor of Distance Learning

This study aims to create a Digital Book mathematical economics to improve the self-efficacy of students, where Media Powtoon, Augmented Reality (AR) and application Kahoot already present in the design of digital books. To see the feasibility of the book, the attractiveness of the book and the effectiveness of using AR-assisted Economic Mathematics Books to increase student self-efficacy. The research method used in this research is the development of the ADDIE model which has five stages of research implementation, namely Analysis, Design, Develop, Implement, and Evaluate. Through these five stages, researchers will develop an AR-assisted Mathematics Economics book. In this book, several applications will collaborate in providing the presentation of the material in the form of learning videos using the application Powtoon, displaying animations with Augmented Reality (AR) and evaluating learning outcomes using the application Kahoot, so that this book can help the distance lecture process become more interesting. and effective both in presenting the material, the media used to evaluate learning in lectures. The results of this study show that the Digital Book was developed to conclude that it is feasible, interesting and effective to be used as a distance learning medium and helps students in increasing self-efficacy in learning.

Are Refugees (Really) a Hard-to-Survey Group? Fieldwork Experience with Syrian Refugees in Germany

Abstract Despite the increasing need for representative data on refugee health, refugees are underrepresented in health research in Germany and other European countries. Researchers often describe refugees as a hard-to-survey (or hard-to-reach) population. Labelling refugee populations with this phrase reflects the perspective of mainly local European researchers on a population they do not belong to. Moreover, refugees may not describe themselves with this phrase. Drawing upon my fieldwork experience as a member of the Syrian community in Germany who has conducted research with Syrian refugees, this practice paper challenges a common narrative among researchers in Europe in regard to refugee populations. I strongly recommend that researchers who are interested in conducting research with refugee populations involve them in all research design and implementation stages. I further call upon researchers to refrain from using the label ‘hard-to-survey’ to describe refugee populations before ensuring that they have done enough to engage with and involve their target population in their research.

Recommendations for Sustainable Ancient DNA Research in the Global South: Voices From a New Generation of Paleogenomicists.

Paleogenomics - the study of ancient genomes - has made significant contributions, especially to our understanding of the evolutionary history of humans. This knowledge influx has been a direct result of the coupling of next-generation sequencing with improved methods for DNA recovery and analysis of ancient samples. The appeal of ancient DNA studies in the popular media coupled with the trend for such work to be published in “high impact” journals has driven the amassing of ancestral human remains from global collections, often with limited to no engagement or involvement of local researchers and communities. This practice in the paleogenomics literature has led to limited representation of researchers from the Global South at the research design and subsequent stages. Additionally, Indigenous and descendant communities are often alienated from popular and academic narratives that both involve and impact them, sometimes adversely. While some countries have safeguards against ‘helicopter science’, such as federally regulated measures to protect their biocultural heritage, there is variable oversight in others with regard to sampling and exportation of human remains for destructive research, and differing requirements for accountability or consultation with local researchers and communities. These disparities reveal stark contrasts and gaps in regional policies that lend themselves to persistent colonial practices. While essential critiques and conversations in this sphere are taking place, these are primarily guided through the lens of US-based heritage legislation such as the Native American Graves and Protection Act (NAGPRA). In this article, we aim to expand the scope of ongoing conversations by taking into account diverse regional contexts and challenges drawing from our own research experiences in the field of paleogenomics. We emphasize that true collaborations involve knowledge sharing, capacity building, mutual respect, and equitable participation, all of which take time and the implementation of sustainable research methods; amass-and-publish strategy is simply incompatible with this ethos.

A review of Ethical Considerations in Conducting Clinical Trials

Clinical trials are known as the golden key in medical science researches with human participants. Therefore, they have always been considered interesting topics by researchers and scientists working in this field. On the other hand, due to the “human participants”, they need to be performed very carefully. In this article, we have examined the ethical necessities and considerations in these researches in four stages: Research Design and Question-proposal review , approval - Supervision, implementation and publication of the results We have dealt with them using articles published between 2010 and 2019, and we have identified significantly important and prominent issues or even neglected cases. During this study, it was found that the Research Design and Question stage were the most discussed and challenged stages and the authors' sensitivity about them has been more than the other three stages. On the other hand, the results publishing stage with the least number of references in articles has been considered less sensitive. During this study, it was found that the Research Design was the most discussed and challenged stages and the authors' sensitivity about them has been more than the other three stages. On the other hand, the results publishing stage with the least number of references in articles has been considered less sensitive.

Experimental study of the resistance to the movement of trimaran vessels

The aim of the work is to develop a method for finding the resistance of a trimaran ship at the initial stages of design, depending on the geometric characteristics of the central hull, outriggers and their mutual position. The program of model tests in the experimental tank is characterized. Based on the analysis of the experimentally obtained data, the graphs of the resistance dependence on the Froude number for the trimaran ship model with the fore, central and stern arrangement of outriggers are presented. A graph of the outriggers’ location influence along the vessel length on its hydrodynamic resistance is also shown. A method for calculating the hydrodynamic resistance for a trimaran vessel at the stages of research design is proposed, which is an adjustment of a single-hull vessel model tests’ recalculation classical principle. One of the developed graphs of the residual drag coefficient dependence on the relative speed according to the Froude number for various central hull geometric characteristics of the vessel, outriggers and their relative position is presented. The analysis of serial model tests made it possible to establish the dependence of the trimaran ship resistance on the geometric characteristics of the central hull and outriggers, and their relative position relative to each other in this study. The method proposed in this work will make it possible to substantiate the best layout of outriggers when solving the problem of optimizing the design elements and characteristics of a trimaran at the research design stage.