. The potential for financial conflicts of interest to influence scientific research has become a significant concern. Some commentators have suggested that the development of standardized study protocols could help to alleviate these problems. This paper identifies two problems with this solution: scientific research incorporates numerous methodological judgments that cannot be constrained by standardized protocols; and standardization can hide significant value judgments. These problems arise because of four weaknesses of standardized guidelines: incompleteness, limited applicability, selective ignorance, and ossification. Therefore, (...) the standardization of study designs should not serve as an alternative to addressing the interests and power relations that pervade science policy-making. Policy makers should take at least two steps to prevent powerful interest groups from co-opting standardized guidelines. First, their development and review should be made as transparent as possible and should be subjected to broadly-based deliberation. Second, standardized guidelines should be supplemented with efforts to scrutinize the conditions under which financial COIs tend to have the most worrisome effects so that additional steps can be taken to eliminate and mitigate those conditions. (shrink)

This review considers ethical challenges to research design and informed consent in biomedical and behavioral studies conducted in resource-poor settings. A review of the literature explores relevant social, cultural, and ethical issues in the conduct of biomedical and social health research in developing countries. Ten case vignettes illustrate ethical challenges that arise in international research with culturally diverse populations. Recommendations for researchers and policy-makers concerned about ethical practices in multinational studies conducted in resource-poor settings are also listed.

BackgroundEthics is the science of moral and ethical rules recognised in human life and attempts to verify what is morally right and wrong. Healthcare ethics is seen as an integrated part of the daily activities of health facilities. Healthcare professionals’ standardisation and uniformity in healthcare ethics are urgent and basic requirements. Therefore, this study aimed to assess the practice of the code of ethics and associated factors among health professionals in Central Gondar Zone public hospitals, Northwest Ethiopia, 2021.MethodsA facility-based (...) cross-sectional study design with a mixed method was conducted on 631 health professionals from Central Gondar Zone public hospitals. For the quantitative part, pre-tested self-administered questionnaires were used, and for the qualitative part, key informant interviews with a semi-structured questionnaire were used. Variables with a p value of < 0.2 in binary logistic regression entered into a multivariable logistic regression, then p value < 0.05 and AOR were used to declare statistically significant variables in quantitative data. A thematic content analysis was used for qualitative data analysis.ResultsThis study revealed that only 286 health professionals had good practice of the code of ethics. Good ethical knowledge, favourable attitude, and satisfaction of health professionals with their jobs were significantly associated with the practice of health care ethics.ConclusionsHealth professionals' overall level of practice of health care ethics in the Central Gondar Zone public hospitals was poor. This necessitates practical training, ongoing follow-up, availing of necessary medical equipment, a smooth working environment, and modification of the recognition system for health professionals. (shrink)

BackgroundOver the past two decades, Uganda has experienced a significant increase in clinical research driven by both academia and industry. This has been combined with a broader spectrum of research proposals, with respect to methodologies and types of intervention that need evaluation by Research Ethics Committees (RECs) with associated increased requirement for expertise. We assessed the competencies of REC members regarding review of research protocols with complex and emerging research study designs. The aim was to guide development of a (...) training curriculum to improve the quality of scientific and ethical review.MethodsThis was a cross-sectional study design, with quantitative data collection methods. Research Ethics Committee members completed a structured pre-coded questionnaire on current competence with complex and emerging study design. REC members were asked to outline a list of additional topics for which they needed training. Data from coded questions were entered into Epidata Version 3.1 and then exported to STATA Version14.1 for analysis. Descriptive analysis was performed and findings are presented using percentages and frequencies.ResultsWe enrolled 55 REC members from 6 RECs who have a total of 97 members. The majority of whom were males (56.4%, n = 31/55). The level of competence for review of selected study design was lowest for Controlled Human Infection Model (10.9%, n = 6) and reverse pharmacology design (10.9%, n = 6), and highest for cluster randomized study design (52.7%, n = 29) and implementation science research (52.7%, n = 29).ConclusionCompetence for review of research protocols with complex and emerging study design was low among participating REC members. We recommend prioritising training of REC members on complex and emerging study designs to enhance quality of research protocol review. (shrink)

Background: Authors are required to describe in their manuscripts ethical approval from an appropriate committee and how consent was obtained from participants when research involves human participants.Objective: To assess the reporting of these protections for several study designs in general medical journals.Design: A consecutive series of research papers published in the Annals of Internal Medicine, BMJ, JAMA, Lancet and The New England Journal of Medicine between February and May 2003 were reviewed for the reporting of ethical approval and (...) patient consent. Ethical approval, name of approving committee, type of consent, data source and whether the study used data collected as part of a study reported elsewhere were recorded. Differences in failure to report approval and consent by study design, journal and vulnerable study population were evaluated using multivariable logistic regression.Results: Ethical approval and consent were not mentioned in 31% and 47% of manuscripts, respectively. 88 papers failed to report both approval and consent. Failure to mention ethical approval or consent was significantly more likely in all study designs than in randomised controlled trials . Failure to mention approval was most common in the BMJ and was significantly more likely than in The New England Journal of Medicine. Failure to mention consent was most common in the BMJ and was significantly more likely than in all other journals. No significant differences in approval or consent were found when comparing studies of vulnerable and non-vulnerable participants.Conclusion: The reporting of ethical approval and consent in RCTs has improved, but journals are less good at reporting this information for other study designs. Journals should publish this information for all research on human participants. (shrink)

The contribution of inherited non‐genetic factors to complex diseases is of great current interest. The ways in which mothers and fathers can affect their offspring's health clearly differ as a result of the intimate interactions between mother and offspring during pre‐ and postnatal life. There is, however, potential for some overlap in mechanisms, particularly epigenetic mechanisms. A small number of epidemiological studies and animal models have investigated the non‐genetic contribution of the parents to offspring health. Discovering new mechanisms of disease (...) inheritance is technically difficult, especially in genetically, socially and environmentally heterogeneous human populations. Therefore, rigorous experimental design, appropriate sample numbers and the use of high‐throughput technologies are necessary to provide convincing evidence. Based on recent examples from the literature, here we propose several ways to improve human studies that aim to identify the underlying mechanisms of transgenerational inheritance of metabolic disease. (shrink)

The use of transcranial Electrical Stimulation in the modulation of cognitive brain functions to improve neuropsychiatric conditions has extensively increased over the decades. tES techniques have also raised new challenges associated with study design, stimulation protocol, functional specificity, and dose-response relationship. In this paper, we addressed challenges through the emerging methodology to investigate the dose-response relationship of High Definition-transcranial Direct Current Stimulation, identifying the role of negative valence in tinnitus perception. In light of the neurofunctional testable framework and (...) tES application, hypotheses were formulated to measure clinical and surrogate endpoints. We posited that conscious pairing adequately pleasant stimuli with tinnitus perception results in correction of the loudness misperception and would be reinforced by concurrent active HD-tDCS on the left Dorsolateral Prefrontal Cortex. The dose-response relationship between HD-tDCS specificity and the loudness perception is also modeled. We conducted a double-blind, randomized crossover pilot study with six recruited tinnitus patients. Accrued data was utilized to design a well-controlled adaptive seamless Bayesian dose-response study. The sample size and optimum interims were anticipated for adaptive decision-making about efficacy, safety, and single session dose parameters. Furthermore, preliminary pilot study results were sufficient to show a significant difference within the longitudinally detected self-report tinnitus loudness between before and under positive emotion induction. This study demonstrated a research methodology used to improve emotion regulation in tinnitus patients. In the projected method, positive emotion induction is essential for promoting functional targeting under HD-tDCS anatomical specificity to indicate the efficacy and facilitate the dose-finding process. The continuous updating of prior knowledge about efficacy and dose during the exploratory stage adapts the anticipated dose-response model. Consequently, the effective dose range to make superiority neuromodulation in correcting loudness misperception of tinnitus will be redefined. Highly effective dose adapts the study to a standard randomized trial and transforms it into the confirmatory stage in which active HD-tDCS protocol is compared with a sham trial. Establishing the HD-tDCS intervention protocols relying on this novel method provides reliable evidence for regulatory agencies to approve or reject the efficacy and safety. Furthermore, this paper supports a technical report for designing multimodality data-driven complementary investigations in emotion regulation, including EEG-driven neuro markers, Stroop-driven attention biases, and neuroimaging-driven brain network dynamics. (shrink)

Discovery science in health over the past two decades has embraced, with considerable enthusiasm, the potential of two movements: precision medicine and the ascent of big data. Each of these developments has been suggested to hold substantial promise both to advance our health science and to lead to the development of approaches that can improve health.Precision medicine—emerging naturally from the Human Genome Project almost two decades ago—promises to use genomic and molecular approaches to identify the causes of disease particular to (...) individuals with the end of helping develop tailored treatments and interventions. This approach builds on what is perhaps a deeply held... (shrink)

General Technology Course in senior high school focuses on skill training and the connection and comprehensive application of interdisciplinary knowledge, and it is a compulsory course for cultivating students' creative potential. However, GTC in domestic senior high school has low teaching efficiency and fails to cultivate students' creativity well. Fortunately, after years of theoretical and practical research in China, the Maker Education, which focuses on cultivating students' innovative ability, has produced well-recognized applied research results. For this reason, this paper integrates (...) the theories of ME into GTC. Combined the characteristics of ME and GTC, and followed the process of creation and the law of the expression of personality traits, we build a model of GTC based on ME to improve students' creativity effectively. In order to improve and optimize the designed teaching model, this study carried out three rounds of Action Research, designed the practical activities of GTC in senior high school, and revised the teaching model through action, observation and reflection continuously. Finally, this paper designed an experimental group and a control group. The experimental group adopts the recommended General Technology teaching model, and the control group adopts the traditional teaching model. Students were asked tested to take pre-test and post-test, and SPSS was used for analysis of ANCOVA and T-test. After analysis, the following experimental results were obtained: the teaching model proposed in this paper can improve students' creativity significantly and effectively; the adventurous, curiosity, imagination, challenge of students also have significant positive improvement. (shrink)

It was proposed that the data from Monte Carlo statistical investigations be subjected to analysis of variance methods rather than the conventional techniques of tabling, graphing, and inspecting the data. Two examples in which analysis of variance methods were applied to published Monte Carlo studies were presented. It was suggested that balanced factorial designs should be used whenever possible in Monte Carlo studies so that analysis of variance methods would be directly applicable. Finally, three advantages of analysis of variance methods (...) over conventional techniques were described and analysis of variance methods were contrasted with a possible alternative analytical method, multiple regression analysis. (shrink)

Human germline gene editing is often debated in hypothetical terms: if it were safe and efficient, on what further conditions would it then be ethically acceptable? This paper takes another course. The key question is: how can scientists reduce uncertainty about safety and efficiency to a level that may justify initiation of first-time clinical trials? The only way to proceed is by well-designed preclinical studies. However, what kinds of investigation should preclinical studies include and what specific conditions should they satisfy (...) in order to be considered well-designed? It is argued that multispecies and multigenerational animal studies are needed as well as human embryo editing without implantation. In order to be possible to translate to first-time clinical trials, animal studies need to satisfy strict conditions of validity. Moreover, embryo studies intended for translation to first-time clinical trials need to correspond to the animal studies in experimental design. Only in this way can uncertainty about risk for harm and prospect of benefit in first-time clinical trials be reduced to a modest level. If uncertainty is not reduced to such a level, first-time clinical trials in germline gene editing should not be initiated. (shrink)

Human germline gene editing is often debated in hypothetical terms: if it were safe and efficient, on what further conditions would it then be ethically acceptable? This paper takes another course. The key question is: how can scientists reduce uncertainty about safety and efficiency to a level that may justify initiation of first-time clinical trials? The only way to proceed is by well-designed preclinical studies. However, what kinds of investigation should preclinical studies include and what specific conditions should they satisfy (...) in order to be considered well-designed? It is argued that multispecies and multigenerational animal studies are needed as well as human embryo editing without implantation. In order to be possible to translate to first-time clinical trials, animal studies need to satisfy strict conditions of validity. Moreover, embryo studies intended for translation to first-time clinical trials need to correspond to the animal studies in experimental design. Only in this way can uncertainty about risk for harm and prospect of benefit in first-time clinical trials be reduced to a modest level. If uncertainty is not reduced to such a level, first-time clinical trials in germline gene editing should not be initiated. (shrink)

The deceptive clues in the impossible puzzle film confirm the viewer’s internal expectations and allow retrospective attributing. In the film, a transcendental object negates an internal expectation, causing a retrospective blockage. Retrospectivity does not stop there; the transcendental object reinterpreting deceptive clues in the associative area leads to repeated attribution. This article consists of three parts. First, it discusses impossible puzzle films in the context of complex narrative classification. The following section introduces the Jungian concept of synchronicity and illustrates how (...) it works. The article concludes with a case study of Long Day’s Journey into Night (2018), which contains more complicated puzzles and explains how mind-game narrative techniques create deceptive clues and induce deceptive retrospective attribution. (shrink)

Smart homes represent an effective approach to improve one’s quality of life. Developing user interfaces that are both comfortable and understandable can assist users, particularly the elderly, embrace smart home technologies. It’s critical to concentrate on the characteristics of smart home interface design and their impact on people of various ages. Since sliders are one of the most common components utilized in the smart home user interface, this article aimed to investigate the effects of slider design characteristics on (...) user performance and preference. Thirty-four participants were recruited for the experiment. Our results revealed that both groups had shorter task completion time, less fixation time, and saccades on horizontal sliding orientation and larger buttons, which means better user performance. For the older group, the slider with color gradient track led to better user performance, while the track color only had less effect on the performance of the younger group. In terms of user preference, the results and performance of the older group were basically consistent, while the younger group had no significant difference in sliding orientation and track color. (shrink)

BackgroundVideo-calls have proven to be useful for older care home residents in improving socialization and reducing loneliness. Nonetheless, to facilitate the acceptability and usability of a new technological intervention, especially among people with dementia, there is a need for user-led design improvements. The current study conducted focus groups with an embedded activity with older people to allow for a person-centered design of a video-call intervention.MethodsTwenty-eight residents across four care homes in the South West of England participated in (...) focus groups to aesthetically personalize and ‘dress-up’ the equipment used in a video-call intervention. Each care home was provided with a ‘Skype on Wheels’ device, a wheelable ‘chassis’ comprising an iPad or tablet for access to Skype, and a telephone handset. During the focus group, residents were encouraged to participate in an activity using colorful materials to ‘dress-up’ SoW. Comments before, during and after the ‘dress up’ activity were audio recorded. Framework analysis was used to analyze the focus group data.ResultsOlder people, including seven with dementia were able to interact with and implement design changes to SoW through aesthetic personalization. Themes arising from the data included estrangement, anthropomorphism, reminiscence, personalization, need for socialization versus fear of socialization and attitudes toward technology. After this brief exposure to SoW, residents expressed the likelihood of using video-calls for socialization in the future.ConclusionCare home residents enjoy engaging with new technologies when given the opportunity to interact with it, to personalize it and to understand its purpose. Low cost aesthetic personalization of technologies can improve their acceptability, usability, and implementation within complex care environments. (shrink)

The increasing availability of passively observed data has yielded a growing interest in “data fusion” methods, which involve merging data from observational and experimental sources to draw causal conclusions. Such methods often require a precarious tradeoff between the unknown bias in the observational dataset and the often-large variance in the experimental dataset. We propose an alternative approach, which avoids this tradeoff: rather than using observational data for inference, we use it to design a more efficient experiment. We consider the (...) case of a stratified experiment with a binary outcome and suppose pilot estimates for the stratum potential outcome variances can be obtained from the observational study. We extend existing results to generate confidence sets for these variances, while accounting for the possibility of unmeasured confounding. Then, we pose the experimental design problem as a regret minimization problem subject to the constraints imposed by our confidence sets. We show that this problem can be converted into a concave maximization and solved using conventional methods. Finally, we demonstrate the practical utility of our methods using data from the Women’s Health Initiative. (shrink)

Throughout the last decades, scientific and therapeutic communities have made common efforts to collect reliable information concerning the efficacy of psychotherapies. One of these initiatives has, recently, involved the psychodrama community and its desire to achieve progress in the validation of this therapy. Based on Robert Elliot's Hermeneutic Single Case Efficacy Design (HSCED), we followed five participants (3 women, 2 men, aged 27-48) of a psychodrama group over the course of their therapeutic process, which ranged from 24 months to (...) 5 years. We chose one of them for the single case study. Quantitative outcome measures included the Portuguese versions of the Revised Spontaneity Assessment Inventory, Clinical Outcome Routine Evaluation and the individualized Personal Questionnaire. Qualitative process measures included Helpful Aspects of Therapy Form and the Client Change Interview. Participants generally reported improvement in their personal therapeutic goals, decrease in symptoms and life problems, and some showed a marked increase in spontaneity levels. In the single case presented, these results are confirmed, and following decision criteria it is possible to assert that the participant improved in all the variables assessed and that therapy is the main cause of these changes. Furthermore, the participant frequently rated psychodrama sessions as being helpful and stated they had a transformational impact on his life. This research contributes towards validating psychodrama as an efficient therapeutic method, hopefully stimulating practitioners to integrate therapy and research - which, for years, were considered independent and incompatible - and to facilitate their use in a complementary way. (shrink)

When scientists attempt to explain observations of behaviour in humans and other animals, they often use language that evolved for informal discourse among people engaged in every day social interaction, like this: What does the infant/child/adult/chimp/crow perceive/understand/learn/intend? What is he/she/it conscious of? What does he/she/it experience/enjoy/desire? What is he/she/it attending to? Why did he/she/it do X, start Xing, stop Xing, speed up Xing...? Does he/she/it know that...? What did/does he/she/it expect will happen, if...? Similar comments can be made about the (...) terminology used in many philosophical discussions about minds, cognition, language, and the relationships between evolution and learning. (shrink)

Previously, language teaching has been focused on the passive learning of the alphabet. In addition, the research on teaching listening and speaking skills was limited. Listening skill is the key to learning a language, and speaking is the first explicit behavior of language. In order to improve language skills which are emphasized in new curriculum guidelines, student-centered thematic language teaching is considered as valuable. Through this, the concepts of multiple intelligences and curriculum integration were re-emphasized. An experimental design was (...) adopted in the current study. This study was conducted with the participation of 224 students from the Department of Multimedia Design in universities in the south of Taiwan. The research data were collected between September 2021 and December 2021. The implementation process took 16 weeks of thematic language teaching. The research results revealed 1. significant positive effects of thematic language teaching on listening, 2. significant positive effects of thematic language teaching on speaking skill, and 3. significant negative effects of thematic language teaching on learning anxiety. According to the results, it is expected that this study can help multimedia design students improve their listening and speaking skills as well as core language skills. (shrink)

We explore the relationship between ethnomethodology (EM), ethnography and the needs of managers and designers in industry, considering both ethnomethodological and industrial criteria of adequacy and explicating their relationship through the concept of “audience.” We examine a range of studies in this light, with a view to their possible candidacy as hybrid studies and identify three types of application of EM studies of work: market research, design, and business improvement. Application in the first of these fields we dub “anthropological,” (...) in that it consists in studying and reporting back on the ways of exotic people (customers). This is the application most commonly found in studies of computer supported co-operative work (CSCW). A second CSCW application, “technomethodology,” involves the introduction of EM concepts into the design process. A further application, dubbed “holding-up-a-mirror,” involves reporting back to members of a setting upon their own activities. We argue that technomethodology and holding-up-a-mirror both offer the possibility of creating hybrid disciplines. We consider the objection that improvement and design involve the introduction of value judgements that threaten the practice of EM indifference, arguing that action research can serve as a guarantee of unique adequacy (UA) by testing the researcher’s understanding as analysis in action in the setting. Furthermore, the standard of reporting required by the UA criterion contributes to the effectiveness of proposed solutions. (shrink)

Novel immune therapies are increasingly based on the molecular differentiation of disease patterns. The related clinical studies are thus more often characterized by the so-called adaptive study designs (umbrella or basket studies including platform studies), which are continuously adjusted based on novel results. This paper analyses new study designs beyond the often-postulated need for regulation in order to identify ethical problems based on typical structural features and to—whenever possible—suggest solutions. To do so, it addresses the following topics: the (...) relationship between social and scientific values of a study as well as aspects of the scientific validity of new forms of evidence; the inclusion of study subjects under the condition of relative uncertainty; specific challenges in the process of ethical approval, and ethical and practical challenges in the process of informing patients and receiving informed consent. Additionally, the topic of a potential risk–benefit assessment of such therapies is addressed. (shrink)

Extant research on design thinking is subjective and limited. This manuscript combines protocol analysis and electroencephalogram to read design thoughts in the core design activities of concept generation phase. The results suggest that alpha band power had event related synchronization in the scenario task and divergent thinking occupies a dominant position. However, it had event related desynchronization in analogy and inference activities, etc., and it is stronger for mental pressure and exercised cognitive processing. In addition, the parietooccipital (...) area differs significantly from other brain areas in most design activities. This study explores the relationship of different design thinking and EEG data, which is innovative and professional in the field of design, providing a more objective data basis and evaluation method for future applied research and diverse educational practices. (shrink)

Investigating the causal relationship between exposure and time-to-event outcome is an important topic in biomedical research. Previous literature has discussed the potential issues of using hazard ratio (HR) as the marginal causal effect measure due to noncollapsibility. In this article, we advocate using restricted mean survival time (RMST) difference as a marginal causal effect measure, which is collapsible and has a simple interpretation as the difference of area under survival curves over a certain time horizon. To address both measured and (...) unmeasured confounding, a matched design with sensitivity analysis is proposed. Matching is used to pair similar treated and untreated subjects together, which is generally more robust than outcome modeling due to potential misspecifications. Our propensity score matched RMST difference estimator is shown to be asymptotically unbiased, and the corresponding variance estimator is calculated by accounting for the correlation due to matching. Simulation studies also demonstrate that our method has adequate empirical performance and outperforms several competing methods used in practice. To assess the impact of unmeasured confounding, we develop a sensitivity analysis strategy by adapting the E-value approach to matched data. We apply the proposed method to the Atherosclerosis Risk in Communities Study (ARIC) to examine the causal effect of smoking on stroke-free survival. (shrink)

When scientists discuss experimental observations, they often, unfortunately, use language that evolved for informal discourse among people engaged in every day social interaction, like this: What does the infant/child/adult/chimp/crow (etc) perceive/understand/learn/intend (etc)? What is he/she/it conscious of? What does he/she/it experience/enjoy/desire? What is he/she/it attending to? Similar comments can be made about the terminology used in many philosophical discussions about minds, cognition, language, and the relationships between evolution and learning.

In this paper the concept of knowledge in seen as embodying dialogue and learning in a shared practice. Sharing a practice involved sharing representations of practice. This necessitates the sharing of experiential knowledge at various levels and in various forms. It is proposed that participatory design can therefore be seen as consisting in dialogue and learning for the development of future practices and representations. The discussion in this paper is situated within the domain of landscape architecture. A study (...) is made of their co-operative practices, which are evolved, in order to show the need for participatory embodied activity (whether expressed verbally or physically) in sharing practical knowledge (e.g. of aesthetic judgement). (shrink)

Employing the National Institute of Mental Health-funded Prevention of Suicide in Primary Care Elderly Collaborative Trial as a case study, we discuss 2 sets of ethical issues: obtaining informed consent for a clinic-based intervention study and using treatment as usual (TAU) as the control condition. We then address these ethical issues in the context of the debate about the quality improvement efforts of health care organizations. Our analysis reveals the tension between ethics and scientific integrity involved with using (...) TAU as a control condition and the difficulty in designing high-quality research in a community-based setting. (shrink)