Various publications claim that medical AI systems perform as well, or better, than clinical experts. However, there have been very few controlled trials and the quality of existing studies has been called into question. There is growing concern that existing studies overestimate the clinical benefits of AI systems. This has led to calls for more, and higher-quality, randomized controlled trials of medical AI systems. While this a welcome development, AI RCTs raise novel methodological challenges that (...) have seen little discussion. We discuss some of the challenges arising in the context of AI RCTs and make some suggestions for how to meet them. (shrink)

This contribution to the “antidepressant debate” focuses on the validity of randomized controlled trials. We argue that: randomized controlled trials do everything possible to methodologically stamp out high placebo response rates rather than reveal the clinical implications, assessing a psychoactive drug’s effects greatly exceeds the purpose of a randomized controlled trial, requiring substantial investigation on normal volunteers, made-up psychiatric diagnostic categories destroy the purpose and logic of the randomized controlled trial (...) as a medical experiment, and adverse drug reactions remain under-studied, under-recognized, and under-appreciated, in parallel with the muting of subjects’ voice and the reliance on surrogate measures of efficacy. The standard psychopharmacotherapy trial has lost virtually all clinical and scientific relevance, and needs complete revamping. The backdrop for the discussion is American biopsychiatry’s insistence that personal difficulties must be viewed as the expression of idiopathic somatic diseases, and the pharmaceutical industry’s dominance of the entire drug treatment research enterprise. (shrink)

ABSTRACT“Evidence-based” methods, which most prominently include randomized controlled trials, have gained increasing purchase as the “gold standard” for assessing the effect of public policies. But the enthusiasm for evidence-based research overlooks questions about the reliability and applicability of experimental findings to diverse real-world settings. Perhaps surprisingly, a qualitative study of British educators suggests that they are aware of these limitations and therefore take evidence-based findings with a much larger grain of salt than do policy makers. Their experience (...) suggests that the real world is more heterogeneous than the world imagined by evidence-based policy enthusiasts. (shrink)

The transferability problem—whether the results of an experiment will transfer to a treatment population—affects not only Randomized Controlled Trials but any type of study. The problem for any given type of study can also, potentially, be addressed to some degree through many different types of study. The transferability problem for a given RCT can be investigated further through another RCT, but the variables to use in the further experiment must be discovered. This suggests we could do better (...) on the epistemological problem of transferability by promoting, in the repeated process of formulating public health guidelines, feedback loops of information from the implementation setting back to researchers who are defining new studies. (shrink)

This article focuses on maternal-fetal surgery (MFS) and on the concept of clinical equipoise that is a widely accepted requirement for conducting randomized controlled trials (RCT). There are at least three reasons why equipoise is unsuitable for MFS. First, the concept is based on a misconception about the nature of clinical research and the status of research subjects. Second, given that it is not clear who the research subject/s in MFS is/are, if clinical equipoise is to be (...) used as a criterion to test the ethical appropriateness of RCT, its meaning should be unambiguous. Third, because of the multidisciplinary character of MFS, it is not clear who should be in equipoise. As a result, we lack an adequate criterion for the ethical review of MFS protocols. In our account, which is based on Chervenak and McCullough's seminal work in the field of obstetric ethics, equipoise is abandoned. and RCT involving MFS can be ethically initiated when a multidisciplinary ethics review board (ERB), having an evidence-based assessment of the risks involved, is convinced that the value of answering the research hypothesis, for the sake of the health interests of future pregnant women carrying fetuses with certain congenital birth defects, justifies the actual risks research participants might suffer within a set limit of low/manageable. (shrink)

What kinds of evidence reliably support predictions of effectiveness for health and social care interventions? There is increasing reliance, not only for health care policy and practice but also for more general social and economic policy deliberation, on evidence that comes from studies whose basic logic is that of JS Mill's method of difference. These include randomized controlled trials, case–control studies, cohort studies, and some uses of causal Bayes nets and counterfactual-licensing models like ones commonly developed in (...) econometrics. The topic of this paper is the 'external validity' of causal conclusions from these kinds of studies. We shall argue two claims. Claim, negative: external validity is the wrong idea; claim, positive: 'capacities' are almost always the right idea, if there is a right idea to be had. If we are right about these claims, it makes big problems for policy decisions. Many advice guides for grading policy predictions give top grades to a proposed policy if it has two good Mill's-method-of difference studies that support it. But if capacities are to serve as the conduit for support from a method-of-difference study to an effectiveness prediction, much more evidence, and much different in kind, is required. We will illustrate the complexities involved with the case of multisystemic therapy, an internationally adopted intervention to try to diminish antisocial behaviour in young people. (shrink)

The present paper deals with the problem of evaluating empirical evidence for therapeutic decisions in medicine. The article discusses the views of Nancy Cartwright and John Worrall on the function that randomization plays in ascertaining causal relations with reference to the therapies applied. The main purpose of the paper is to present a general idea of alternative method of evaluating empirical evidence. The method builds on data analysis that makes use of rough set theory. The first attempts to apply the (...) method show that it is an interesting alternative to randomized controlled trials. (shrink)

Research over the past few decades has shown the positive influence that cognitive, social, and physical activities have on older adults’ cognitive and affective health. Especially interventions in health-related behaviors, such as cognitive activation, physical activity, social activity, nutrition, mindfulness, and creativity, have shown to be particularly beneficial. Whereas most intervention studies apply unimodal interventions, such as cognitive training, this study investigates the potential to foster cognitive and affective health factors of older adults by means of an autonomy-supportive multimodal intervention. (...) The intervention integrates everyday life recommendations for six evidence-based areas combined with psychoeducational information. This randomized controlled trial study compares the effects of a MMI and CT on those of a waiting control group on cognitive and affective factors, everyday life memory performance, and activity in everyday life. Three groups, including a total of 119 adults aged 65–86 years, attended a 5- or 10-week intervention. Specifically, one group completed a 10-week MMI, the second group completed 5-week of computer-based CT followed by a 5-week MMI, whereas the third group paused before completing the MMI for the last 5 weeks. All participants completed online surveys and cognitive tests at three test points. The findings showed an increase in the number and variability of activities in the everyday lives of all participants. Post hoc analysis on cognitive performance of MMI to CT indicate similar or better effects. Furthermore, results on far transfer variables showed interesting trends in favor of the MMI, such as increased well-being and attitude toward the aging brain. Also, the MMI group showed the biggest perceived improvements out of all groups for all self-reported personal variables. The results implicate a positive trend toward MMI on cognitive and affective factors of older adults. These tendencies show the potential of a multimodal approach compared to training a specific cognitive function. Moreover, the findings suggest that information about MMI motivates participants to increase activity variability and frequency in everyday life. Finally, the results could also have implications for the primary prevention of neurocognitive deficits and degenerative diseases. (shrink)

Nancy is ultimately most concerned about how to determine the relevance of evidence to implementation of evidence-based policy guidelines, in other words, the transferability of study results to a population different from the one that was studied and in which procedures or conditions are not the same as those in the study. And she is concerned about the privileged position Randomized Controlled Trials (RCTs) are given in the ranking schemes for evidence-based policy, because as she sees it (...) RCTs do not address this question while other methods do. RCTs are highly regarded because of their strength in ruling out confounding variables, but they can be weak on the transferability problem because the manipulations necessary for controlled experiment also guarantee that the setting and population are different from the situation and population targeted for application. However, both of these familiar points are simplifications that can be misleading. Some non-RCT type studies (e.g. soft interventions) can also be very good at ruling out confounding variables.1 And, as I will explain, the problems leading to the transferability problem – interacting variables and a difference between study and target populations – are present in any study, not unique to RCTs. In addition. (shrink)

The Flash Technique of Eye Movement Desensitization and Reprocessing is widely recognized for its effectiveness in reducing the effects of emotional responses associated with traumatic memories. Using a randomized-controlled trial methodology, this study attempts to establish the efficacy of the EMDR Flash Technique. This study’s sample includes volunteers who were involved in traffic accidents and were given the randomized EMDR Flash Technique and Improving Mental Health Training for Primary Care Residents Stress management module. The participants were given (...) a socio-demographic data form, the Depression-Anxiety-Stress 21 scale, the Impact of Event Scale-Revised, and the WHOQOL Quality of Life scale. Participants were evaluated using measurements taken before and after the application, as well as a one-month follow-up. The mean age of the participants was 36.20 years and 82.1% were female. The DASS-21 Anxiety, IES-R Intrusion, Avoidance, Total, and WHOQOL-BREF Psychological score improvements of the EMDR Flash Technique group were shown to be statistically significant when compared to the mhGAP group. However, no statistically significant difference in the DASS-21 Depression, Stress, Impact of Event Scale-Revised Hyperarousal WHOQOL-BREF General Health, Physical, Social Relationships, and Environment component scores was reported between the two groups. The present study’s findings clearly demonstrate that the EMDR Flash technique, when applied to persons involved in traffic accidents, is successful in improving anxiety, intrusion, avoidance, total traumatic stress, and mental quality of life symptoms for at least 1 month. We believe that these findings will improve the reliability and applicability of the EMDR Flash Technique, which was tested for the first time in a clinical randomized-controlled trial. (shrink)

In 2003 and 2018 researchers discussed the perils of blind reliance on randomized controlled trials that have been substituted for medical experience and clinical acumen. Although these past articles do well to shed light on this issue, they neglect to discuss the topic of all-cause mortality in controlled trials. The current essay seeks to fill this void and expand the thought put into the appropriateness of all-cause mortality, especially when trials extend excessively far into (...) the future. To do this effectively the current essay leans on trial data from statin research and evidence from cancer screening—where researchers have explicitly called for all-cause mortality to be used in lieu of cancer or cardiovascular specific mortality. The issue with such an endpoint is that it obfuscates the issue at hand, namely that a specific intervention is intended to have a specific effect, not that a specific intervention is supposed to have any kind of effect. The effect(s) of medical interventions ought to be relevant to their intended mechanism of action and not simply any positive effect that can be pulled from trial data. (shrink)

We raise a problem of applicability of RCTs to validate nuclear diagnostic imaging tests. In spite of the wide application of PET and other similar techniques that use radiopharmaceuticals for diagnostic purposes, RCT-based evidence on their validity is sparse. We claim that this is due to a general conceptual problem that we call Prevalence of Treatment, which arises in connection with designing RCTs for testing any diagnostic procedure in the present context of medical research, and is particularly apparent in this (...) case. We also identify three practical reasons why RCTs do not qualify as the best option for PET validation, which have to do with specific characteristics of nuclear diagnostic imaging, and of radiopharmaceuticals. The paper is meant to contribute both to the philosophical discussion on the EBM hierarchy of evidence, and on the specific debate on radiopharmaceuticals in nuclear medicine. (shrink)

ObjectiveThis study aims to evaluate the effectiveness of the MotivAir program—a phone-based intervention based on Motivational Interviewing principles and techniques—in enhancing adherence to Continuous Positive Airway Pressure therapy among patients with Obstructive Sleep Apnea Syndrome.MethodsA multicenter randomized controlled trial design with random allocation at the level of the individual will be conducted to compare the impact of the experimental program with a control group receiving usual care only in improving selected clinical and psychological parameters in the patients. A (...) minimum sample of 80 participants will be recruited in each center according to the inclusion criteria. After the initial screening, participants will be randomly assigned to either the experimental group or the control condition. The program will last 180 days and will be delivered by a trained nurse. The impact of the MotivAir program on selected primary and secondary outcomes will be measured at baseline, and after 1-, 3-, and 6-month from CPAP initiation.DiscussionParticipants are expected to show an increased level of adherence to CPAP and to acquire the skills and self-confidence necessary to deal with the psychological consequences of their chronic condition. (shrink)

Introduction: Probationers, offenders with less serious and non-violent offences, and under statutory supervision, have low levels of self-esteem and physical health, and high level of family conflict, and poorer quality of family relationships. This study examined the effectiveness of the existing probation service and the additional use of a positive family holistic health intervention to enhance physical, psychological, and family well-being in probationers and relationships with probation officers.Methods: Probationers under the care of the Hong Kong Social Welfare Department were (...) class='Hi'>randomized into a care-as-usual control group, a brief intervention group receiving two 1-h individual sessions [of a brief theory-based positive family holistic health intervention integrating Zero-time Exercise and positive psychology themes of “Praise and Gratitude” in the existing probation service], or a combined intervention group receiving BI and a 1-day group activity with family members. The outcomes were physical activity, fitness performance, self-esteem, happiness, anxiety and depression symptoms, life satisfaction, quality of life, family communication and well-being, and relationships with probation officers. Self-administered questionnaires and simple fitness tests were used at baseline, 1-month and 3-month follow-up. Linear mixed model analysis was used to compare difference in the changes of outcome variables among groups, adjusted of sex, age, and baseline values. Focus group interviews were conducted. Thematic content analysis was used.Results: 318 probationers were randomized into CAU, BI, or CI group. CAU showed enhanced physical activity, fitness performance and psychological health, and family communication with small effect sizes. BI and CI showed further improved physical activity, family communication and family well-being. Additionally, CI reported greater improvements in the relationships with probation officers than CAU with a small effect size. CI also reported greater increases in physical activity and family communication than BI with small to moderate effect sizes. Qualitative feedbacks corroborated the quantitative findings.Conclusion: Our trial provided the first evidence of the effectiveness of probation service and the additional use of an innovative, relatively low-cost, theory-based brief positive family holistic health intervention. This intervention may offer a new model for enhancing probation service.Trial Registration: The research protocol was registered at the National Institutes of Health. (shrink)

This article brings a historical perspective to explain the recent dissemination of randomized controlled trials (RCTs) as the new “gold standard” method to assess international development projects. Although the buzz around RCT evaluations dates from the 2000s, we show that what we are witnessing now is a second wave of RCTs, while a first wave began in the 1960s and ended by the early 1980s. Drawing on content analysis of 123 RCTs, participant observation, and secondary sources, we (...) compare the two waves in terms of the participants in the network of expertise required to carry out field experiments and the characteristics of the projects evaluated. The comparison demonstrates that researchers in the second wave were better positioned to navigate the political difficulties caused by randomization. We explain the differences in the expertise network and in the type of projects as the result of concurrent transformations in the fields of development aid and the economics profession. We draw on Andrew Abbott’s concept of “hinges,” as well as on Bourdieu’s concept of “homology” between fields, to argue that the similar positions and parallel struggles conducted by two groups of actors in the two fields served as the basis for a cross-field alliance, in which RCTs could function as a “hinge” linking together the two fields. (shrink)

In his recent book, Keith Morrison argues that RCTs have garnered a privileged place in educational research, driving out other valuable approaches. Morrison acknowledges RCTs or similar designs ca...

Depuis le début des années 2000, les essais randomisés contrôlés ont connu un fulgurant retour sur le devant de la scène académique dans le domaine de l’économie du développement et plus généralement dans celui de l’évaluation des politiques publiques. Alors que ses partisans revendiquent une filiation avec les essais cliniques randomisés en médecine, ces derniers demeurent mal connus par les économistes. Cet article vise à combler ce manque en proposant une comparaison de l’usage et des limites des essais contrôlés randomisés (...) entre la médecine et l’économie. Nous montrons ainsi que si cette méthode est bien souvent placée au sommet de la hiérarchie des preuves en médecine, des voix critiques existent et méritent d’être prises en compte pour penser son application en économie. Nous soulignons également que le traitement du problème de la généralisation des résultats, très bien documenté en médecine, permet de nuancer l’intérêt de la méthode en économie. (shrink)

This short review piece is from a textbook on Medical Ethics.

This article brings a historical perspective to explain the recent dissemination of randomized controlled trials (RCTs) as the new “gold standard” method to assess international development projects. Although the buzz around RCT evaluations dates from the 2000s, we show that what we are witnessing now is a second wave of RCTs, while a first wave began in the 1960s and ended by the early 1980s. Drawing on content analysis of 123 RCTs, participant observation, and secondary sources, we (...) compare the two waves in terms of the participants in the network of expertise required to carry out field experiments and the characteristics of the projects evaluated. The comparison demonstrates that researchers in the second wave were better positioned to navigate the political difficulties caused by randomization. We explain the differences in the expertise network and in the type of projects as the result of concurrent transformations in the fields of development aid and the economics profession. We draw on Andrew Abbott’s concept of “hinges,” as well as on Bourdieu’s concept of “homology” between fields, to argue that the similar positions and parallel struggles conducted by two groups of actors in the two fields served as the basis for a cross-field alliance, in which RCTs could function as a “hinge” linking together the two fields. (shrink)

The epistemological principles underlying randomized, controlled trials and evidence-based medicine generally have not received the attention they require. Broadly speaking, they are the application of work done over several centuries in philosophy and scientific method. The epistemological base is sound, but it also implies internal limitations, having to do with decreasing generality, which particularly affect application to psychological problems. The principles also have nothing to say about values. The question of the 'objective validity' of scientific method is (...) briefly discussed. (shrink)

ObjectiveTo explore the effect of modified constraint-induced movement therapy on upper limbs residual dysfunction for infancy with the sequelas of unilateral brachial plexus injury.MethodsSingle blind randomized controlled trial of mCIMT vs. standard care. An enrolling 31 infants with a uBPI exhibiting residual dysfunction of the affected upper limb for over 6 months was conducted. And functional outcomes pertaining to the affected upper limb were assessed via AMS, GRES, RHS, and MSS at 0, 3, and 6 months after treatment.ResultsNo (...) differences were found in baseline AMS, MSS, GRES, or RHS between the control and mCIMT groups [F = 0.062, P = 0.086; F = 0.483, P = 0.499; F = 0.272, P = 0.610; Z = −0.336, P = 7.373]. At the 3- and 6-month follow-up time points, AMS, MSS, and GRES scores were significantly improved over baseline in both groups [mCIMT: F = 183.750, 128.614, 110.085, P < 0.05; Control: F = 204.007, 75.246, 51.070, P < 0.05]. No significant differences were found between two treatment groups at the 3-month follow-up time point [F = 0.565, P = 0.465; F = 0.228, P = 0.641; F = 0.713, P = 0.413; Z = −0.666, P = 0.505]. However, at the 6-month follow-up time point, AMS and MSS scores were significantly improved in the mCIMT group relative to the control group [F = 8.077, P = 0.013; F = 18.692, P = 0.001].ConclusionmCIMT may benefit the rehabilitation of residual upper limb dysfunction associated with a uBPI in infants.Clinical Trial Registration[www.chictr.org.cn], identifier [ChiCTR1900022119]. (shrink)

Biomedical research and study design have recently been examined in detail by philosophers of science, who, like biomedical researchers, are concerned with the ability to accurately represent causal relationships through scientific study and apply these relationships to improve the health of individuals and populations. Epistemology—defined by the OED as "the theory of knowledge, especially with regard to its methods, validity, and scope, and the distinction between justified belief and opinion"—is fundamental to these concerns. In particular, philosophers of science and biomedical (...) researchers have discussed the epistemological value of randomized-controlled trials in regards to their individual components.... (shrink)

Madole & Harden argue that just as the results of randomized controlled trials (RCTs) represent gains in causal knowledge and are useful, despite their limitations, so too are the findings of human behavior genetics. We argue that this analogy is misleading. Unlike RCTs, the results of human behavior genetics research cannot suggest efficacious interventions, nor point toward future research.

BackgroundTrial registration helps minimize publication and reporting bias. In leading medical journals, 96% of published trials are registered. The aim of this study was to determine the proportion of randomized controlled trials published in key nursing journals that met criteria for timely registration.MethodsWe reviewed all RCTs published in three (two general, one mental health) nursing journals between August 2011 and September 2016. We classified the included trials as: 1. Not registered, 2. Registered but not reported (...) in manuscript, 3. Registered retrospectively, 4. Registered prospectively (before the recruitment of the first subject into the trial). 5. Timely registration (as 4 but the trial identification number is reported in abstract).ResultsWe identified 135 trials published in the three included journals. The majority (n = 78, 58%) were not registered. Thirty-three (24%) were retrospectively registered. Of the 24 (18%) trials that were prospectively registered, 11 (8%) met the criteria for timely registration.ConclusionsThere is an unacceptable difference in rates of trial registration between leading medical and nursing journals. Concerted effort is required by nurse researchers, reviewers and journal editors to ensure that all trials are registered in a timely way. (shrink)

Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content analysis. Our (...) review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs. (shrink)

The current study is a pilot trial to examine the effects of a nonelective, classroom-based, teacher-implemented, mindfulness meditation intervention on standard clinical measures of mental health and affect in middle school children. A total of 101 healthy sixth-grade students (55 boys, 46 girls) were randomized to either an Asian history course with daily mindfulness meditation practice (intervention group) or an African history course with a matched experiential activity (active control group). Self-reported measures included the Youth Self Report (YSR), a (...) modified Spielberger State-Trait Anxiety Inventory, and the Cognitive and Affective Mindfulness Measure –Revised. Both groups decreased significantly on clinical syndrome subscales and affect but did not differ in the extent of their improvements. Meditators were significantly less likely to develop suicidal ideation or thoughts of self-harm than controls. These results suggest that mindfulness training may yield both unique and non-specific benefits that are shared by other novel activities. (shrink)

Background Pragmatic randomized controlled trials are designed to evaluate the effectiveness of interventions in real-world clinical conditions. However, these studies raise ethical issues for researchers and regulators. Our objective is to identify a list of key ethical issues in pragmatic RCTs and highlight gaps in the ethics literature. Methods We conducted a scoping review of articles addressing ethical aspects of pragmatic RCTs. After applying the search strategy and eligibility criteria, 36 articles were included and reviewed using content (...) analysis. Results Our review identified four major themes: 1) the research-practice distinction; 2) the need for consent; 3) elements that must be disclosed in the consent process; and 4) appropriate oversight by research ethics committees. 1) Most authors reject the need for a research-practice distinction in pragmatic RCTs. They argue that the distinction rests on the presumptions that research participation offers patients less benefit and greater risk than clinical practice, but neither is true in the case of pragmatic RCTs. 2) Most authors further conclude that pragmatic RCTs may proceed without informed consent or with simplified consent procedures when risks are low and consent is infeasible. 3) Authors who endorse the need for consent assert that information need only be disclosed when research participation poses incremental risks compared to clinical practice. Authors disagree as to whether randomization must be disclosed. 4) Finally, all authors view regulatory oversight as burdensome and a practical impediment to the conduct of pragmatic RCTs, and argue that oversight procedures ought to be streamlined when risks to participants are low. Conclusion The current ethical discussion is framed by the assumption that the function of research oversight is to protect participants from risk. As pragmatic RCTs commonly involve usual care interventions, the risks may be minimal. This leads many to reject the research-practice distinction and question the need for informed consent. But the function of oversight should be understood broadly as protecting the liberty and welfare interest of participants and promoting public trust in research. This understanding, we suggest, will focus discussion on questions about appropriate ethical review for pragmatic RCTs. (shrink)

BACKGROUND -/- The importance of ontologies in the biomedical domain is generally recognized. However, their quality is often too poor for large-scale use in critical applications, at least partially due to insufficient training of ontology developers. -/- OBJECTIVE -/- To show the efficacy of guideline-based ontology development training on the performance of ontology developers. The hypothesis was that students who received training on top-level ontologies and design patterns perform better than those who only received training in the basic principles of (...) formal ontology engineering. -/- METHODS -/- A curriculum was implemented based on a guideline for ontology design. A randomized controlled trial on the efficacy of this curriculum was performed with 24 students from bioinformatics and related fields. After joint training on the fundamentals of ontology development the students were randomly allocated to two groups. During the intervention, each group received training on different topics in ontology development. In the assessment phase, all students were asked to solve modeling problems on topics taught differentially in the intervention phase. Primary outcome was the similarity of the students’ ontology artefacts compared with gold standard ontologies developed by the authors before the experiment; secondary outcome was the intra-group similarity of group members’ ontologies. -/- RESULTS -/- The experiment showed no significant effect of the guideline-based training on the performance of ontology developers (a) the ontologies developed after specific training were only slightly but not significantly closer to the gold standard ontologies than the ontologies developed without prior specific training; (b) although significant differences for certain ontologies were detected, the intra-group similarity was not consistently influenced in one direction by the differential training. -/- CONCLUSION -/- Methodologically limited, this study cannot be interpreted as a general failure of a guideline-based approach to ontology development. Further research is needed to increase insight into whether specific development guidelines and practices in ontology design are effective. (shrink)

BackgroundMental illness among Malaysian children is gradually reaching a fundamentally alarming point as it persistently shows increasing trend. The existing literature on the etiologies of children’s mental illness, highlights the most common cause to be ineffective or impaired parenting. Thus, efforts to combat mental illness in children should focus on improving the quality of parenting. Documented interventional studies focusing on this issue, particularly in Malaysia, are scarce and commonly report poor treatment outcomes stemming from inconvenient face-to-face instructions. Consequently, proposing an (...) accessible online and digital-assisted parenting program is expected to reach a larger number of parents, as it can overcome substantial barriers. Hence, this study aims to develop a universal digital-assisted preventive parenting intervention called DaPI, that aims to enhance mental health of children in Malaysia.MethodsA total of 200 parents of children aged 10–14 years will be recruited and randomized into two groups either intervention or waitlist-control based on a 1:1 ratio for a duration of 8 weeks. Those in the intervention group will receive eight sessions of the DaPI program that focus mainly on parenting and children’s mental health. The primary outcome of this study will essentially focus on the changes in parent-reported parenting behavior and parental self-efficacy. The secondary outcome will be changes in children’s mental health. Assessments will be arranged pre- and post-intervention as well as at the 1-month follow-up. Analyses will be conducted using a paired t-test and multivariate analysis of covariance.DiscussionThe expected outcome will be the establishment of DaPI in promoting children’s mental health by targeting changes in parenting behavior and parental self-efficacy in Malaysia. Findings from this study will be beneficial for policymakers to invest in parenting programs that could provide support to parents in enhancing their child’s overall development.Clinical trial registration[www.irct.ir], identifier [IRCT20211129053207N1]. (shrink)