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)

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)

The maternal‐fetal HIV transmission trials, conducted in developing countries in the 1990s, undoubtedly generated one of the most intense, high profile controversies in international research ethics. They sparked off a prolonged acrimonious and public debate and deeply divided the scientific community. They also provided an impetus for the revision of the Declaration of Helsinki – the most widely known guideline for international research. In this paper, I provide a brief summary of the context, outline the arguments for and against (...) the controversial use of placebo controls, and focus on particular areas that I believe merit further discussion or clarification. On balance, I argue that the researchers failed in their duties to protect the best interests of their research subjects, and to promote distributive justice. I discuss the difficulties of obtaining valid consent in this research context, and argue that it is unethical to inform women of their HIV status without at least offering them prophylactic treatment for their unborn children. A global view of justice, which endorses international equity, cannot be squared with international research guidelines that allow ‘local conditions’ to define the scope of duty to the control group. Finally, I suggest that the heated debate reflects a tension, if not an outright war, between two conflicting meta‐ethical systems, or incommensurable paradigms, that underpin scientific research involving human subjects. (shrink)

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 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)

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)

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)

Background Ethically, informed consent regarding randomised controlled trials (RCTs) should be understandable to patients. The patients can then give free consent or decline to participate in a RCT. Little is known about what patients really understand in consultations about RCTs. Methods Cancer patients who were asked to participate in a randomised trial were surveyed using a semi-standardised interview developed by the authors. The interview addresses understanding, satisfaction and needs of the patients. The sample included eight patients who participated (...) in a trial and two who declined. The data were analysed on the basis of Mayring's qualitative analysis. Results Patients' understanding of informed consent was less developed than anticipated, especially concerning key elements such as randomisation, content and procedure of RCTs. Analysing the result about satisfaction of the patients, most of the patients described their consultations as hectic and without advance notice. Health limitations due to cancer played a decisive role. However, most of the patients perceived their physician to be sympathetic. Analysing the needs of patients, they ask for a clear informed consent consultation with enough time and adequate advance notice. Conclusion This study fills an important empirical research gap of what is ethically demanded in an RCT consultation and what is really understood by patients. The qualitative approach enabled us to obtain new results about cancer patients' understanding of informed consent, to clarify patients' needs and to develop new ideas to optimise the informed consent. (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)

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)

This study explored drug users’ attitudes toward and understanding of randomized controlled trials testing addiction therapies. A video portraying a fictional consent conference for a randomized controlled trial with placebo arm was shown to poor male and female drug users of diverse ethnic status and sexual orientation. The video stimulated focus group discussion in which participants’ comments often reflected “experimental realism”—a realistic view of the trial—and adequate understanding of the uncertain efficacy of the treatment being (...) tested, as well as the concepts of randomization and placebo control. However, participants’ comprehension of the nature of placebos was compromised by the widespread view that placebos are a way of testing a subject’s willpower and personal control over his or her addiction. Comments also showed a mistrust of the video investigator’s integrity and competence and signs of therapeutic misconception and misestimation. The study’s findings underscore the importance of tailoring informed consent encounters to the personal and sociohistorical context of participants’ lived experiences. (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)

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)

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)

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)

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)

ABSTRACT Background: Explaining technical terms in consent forms prior to seeking informed consent to recruit into trials can be challenging in developing countries, and more so when the studies are randomized controlled trials. This study was carried out to examine the opinions of researchers on ways of dealing with these challenges in developing countries. Methods: Recorded in‐depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school (...) of public health in the United Kingdom. A purposive, snowballing approach was used to identify interviewees. Results: Researchers were divided on the feasibility of explaining technical trials in illiterate populations; the majority of them held the view that local analogies could be used to explain these technical terms. Others were of the opinion that this could not be done since it was too difficult to explain technical trials, such as randomized controlled trials, even to people in developed countries. Conclusion: Researchers acknowledged the difficulty in explaining randomized controlled trials but it was also their perception that this was an important part of the ethics of the work of scientific research involving human subjects. These difficulties notwithstanding, efforts should be made to ensure that subjects have sufficient understanding to consent, taking into account the fact that peculiar situations in developing countries might compound this difficulty. (shrink)

Randomized controlled trial trial designs exist on an explanatory-pragmatic spectrum, depending on the degree to which a study aims to address a question of efficacy or effectiveness. As conceptualized by Schwartz and Lellouch in 1967, an explanatory approach to trial design emphasizes hypothesis testing about the mechanisms of action of treatments under ideal conditions, whereas a pragmatic approach emphasizes testing effectiveness of two or more available treatments in real-world conditions. Interest in, and the number of, pragmatic trials (...) has grown substantially in recent years, with increased recognition by funders and stakeholders worldwide of the need for credible evidence to inform clinical decision-making. This increase has been accompanied by the onset of learning healthcare systems, as well as an increasing focus on patient-oriented research. However, pragmatic trials have ethical challenges that have not yet been identified or adequately characterized. The present study aims to explore the views of key stakeholders with respect to ethical issues raised by the design and conduct of pragmatic trials. It is embedded within a large, four-year project that seeks to develop guidance for the ethical design and conduct of pragmatic trials. As a first step, this study will address important gaps in the current empirical literature with respect to identifying a comprehensive range of ethical issues arising from the design and conduct of pragmatic trials. By opening up a broad range of topics for consideration within our parallel ethical analysis, we will extend the current debate, which has largely emphasized issues of consent, to the range of ethical considerations that may flow from specific design choices. Semi-structured interviews with key stakeholders, across multiple jurisdictions, identified based on their known experience and/or expertise with pragmatic trials. We expect that the study outputs will be of interest to a wide range of knowledge users including trialists, ethicists, research ethics committees, journal editors, regulators, healthcare policymakers, research funders and patient groups. All publications will adhere to the Tri-Agency Open Access Policy on Publications. (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)

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)

Background: Explaining technical terms in consent forms prior to seeking informed consent to recruit into trials can be challenging in developing countries, and more so when the studies are randomized controlled trials. This study was carried out to examine the opinions of researchers on ways of dealing with these challenges in developing countries.Methods: Recorded in‐depth interviews with 12 lecturers and five doctoral students, who had carried out research in developing countries, at a leading school of public (...) health in the United Kingdom. A purposive, snowballing approach was used to identify interviewees.Results: Researchers were divided on the feasibility of explaining technical trials in illiterate populations; the majority of them held the view that local analogies could be used to explain these technical terms. Others were of the opinion that this could not be done since it was too difficult to explain technical trials, such as randomized controlled trials, even to people in developed countries.Conclusion: Researchers acknowledged the difficulty in explaining randomized controlled trials but it was also their perception that this was an important part of the ethics of the work of scientific research involving human subjects. These difficulties notwithstanding, efforts should be made to ensure that subjects have sufficient understanding to consent, taking into account the fact that peculiar situations in developing countries might compound this difficulty. (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.

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)

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)

Over the past several decades, we devoted much energy to generating, reviewing and summarizing evidence. We have given far less attention to the issue of how to thoughtfully apply the evidence once we have it. That’s fine if all we care about is that our clinical decisions are evidence-based, but not so good if we also want them to be well-reasoned. Let us not forget that evidence based medicine (EBM) grew out of an interest in making medicine ‘rational’, with the (...) idea that rational clinical evaluations should be evidence-based. I agree with the uncontroversial statement that the best decision is supported, at least in part, by the best available evidence. Rationality, however, is constituted by reasoning, not evidence. Complete arguments are necessary for rational evaluations, arguments that begin with general evidence and end in a conclusion about a particular patient. In order to traverse these inferential gaps, medicine must address the issue of how to establish, as an intermediate premise, what the evidence has to say about the efficacy of an intervention for particular patients in a particular practice setting. (shrink)

There is a gap of knowledge about the extent to which gratitude is indeed the working mechanism of change in gratitude interventions aiming to promote mental well-being. This study explores the mediational role of gratitude as mood in the context of a recently conducted randomized controlled trial on the effects of a 6-week gratitude intervention on mental well-being in comparison with a waitlist control group. Gratitude as mood was measured at 2, 4, and 6 weeks. Both simple and (...) multiple mediation models were conducted as well as various sensitivity analyses. Results showed a gradual increase of gratitude as mood during the intervention. The effects of the 6-week gratitude intervention on mental well-being were mediated by increases of gratitude as mood at 4 weeks but not at 2 weeks. These findings suggest a dose-response relationship for gratitude interventions, but more research is warranted. (shrink)

This afterword extends and refines the arguments presented in Cohen and Jacobs . The main point made by the authors is that the antidepressant randomized controlled trial world is a make-believe world in which researchers act as if a bona fide medical experiment is being conducted. From the assumed existence of the “disorder” and the assumed homogeneity of the treatment groups, through the validity of rating scales and the meaning of their scores, to the presentations of researchers’ ratings (...) as the genuine outcome of interest — all aspects of such trials are make-believe. The continued acceptance of randomized controlled trials as appropriate mechanisms to ascertain the actual effects of psychoactive drugs on human beings in distress confirms that researchers are inextricably dependent on large-scale organizational and financial interests that require the sustained production of make-believe results about psychoactive drugs. (shrink)

This new edition of Charles Fried's 'Medical Experimentation' includes a general introduction by Franklin Miller and the late Alan Wertheimer, a reprint of the 1974 text, an in-depth analysis by Harvard Law School scholars I. Glenn Cohen and D. James Greiner, and a new essay by Fried reflecting on the original text and how it applies to the contemporary landscape of medicine and medical experimentation.

This study investigated the effects of the 6 Minutes Journal, a commercial diary combining several positive psychology interventions, including gratitude, goal-setting, and self-affirmation exercises, on several mental health outcome measures. In a randomized controlled trial, university students were randomly assigned to one of two groups: 6MT and a wait list control group. Participants in the intervention group were instructed to follow the instructions of the 6MT for 4 weeks. Participants in both groups completed measures of perceived stress, positive (...) and negative affect, self-efficacy and resilience at baseline, after 2, and 4 weeks. We used path-analyses with autoregressive and cross-lagged effects to test our hypotheses of the effects of the 6MT. Participants in the intervention group reported decreased levels of perceived stress and negative affect, as well as increased levels of resilience and self-efficacy compared to the control group. Positive affect was not statistically significantly influenced. The data showed a statistically significant increased levels of self-efficacy and resilience only after 4 weeks, suggesting that changing these constructs needs more time. The 6-minute diary does not appear to make individuals fundamentally more positive. However, the intervention may have a protective function against negative influences on well-being. (shrink)

A background assumption of this paper is that the repertoire of inference schemes available to humanity is not fixed, but subject to change as new schemes are invented or refined and as old ones are obsolesced or abandoned. This is particularly visible in areas like health and environmental sciences, where enormous societal investment has been made in finding ways to reach more dependable conclusions. Computational modeling of argumentation, at least for the discourse in expert fields, will require the possibility of (...) modeling change in a stock of schemes that may be applied to generate conclusions from data. We examine Randomized Clinical Trial, an inference scheme established within medical science in the mid-20th Century, and show that its successful defense by means of practical reasoning allowed for its black-boxing as an inference scheme that generates (and warrants belief in) conclusions about the effects of medical treatments. Modeling the use of a scheme is well-understood; here we focus on modeling how the scheme comes to be established so that it is available for use. (shrink)

BackgroundEarly in the COVID-19 pandemic, the urgent need to discover effective therapies for COVID-19 prompted questions about the ethical problem of randomization along with its widely accepted solution: equipoise. In this scoping review, uses of equipoise in discussions of randomized controlled trials of COVID-19 therapies are evaluated to answer three questions. First, how has equipoise been applied to COVID-19 research? Second, has equipoise been employed accurately? And third, do concerns about equipoise pose a barrier to the ethical (...) conduct of COVID-19 RCTs?MethodsGoogle Scholar and Pubmed were searched for articles containing substantial discussion about equipoise and COVID-19 RCTs. 347 article titles were screened, 91 full text articles were assessed, and 48 articles were included. Uses of equipoise were analyzed and abstracted into seven categories.Results and discussionApproximately two-thirds of articles used equipoise in a way that is consistent with the concept. They invoked equipoise to support RCTs of specific therapies, RCTs in general, and the early termination of RCTs after achieving the primary outcome. Approximately one-third of articles used equipoise in a manner that is inconsistent with the concept. These articles argued that physician preference, widespread use of unproven therapies, patient preference, or expectation of therapeutic benefit may undermine equipoise and render RCTs unethical. In each case, the purported ethical problem can be resolved by correcting the use of equipoise.ConclusionsOur findings highlight the continued relevance of equipoise as it supports the conduct of well-conceived RCTs and provides moral guidance to physicians and researchers as they search for effective therapies for COVID-19. (shrink)

This article uses the case of “social impact bonds” (SIBs) to explore the role of social science methods in new markets in “social investment.” Pioneered in the UK in 2010, SIBs use private capital to fund social programs with governments paying returns for successful outcomes. Central to the SIB model is the question of evaluation and the method to be used in determining program outcomes and investor returns. In the United States, the randomized controlled trial (RCT) has been (...) the dominant method. However, this has not been without controversy. Some SIB practitioners and investors have argued that, while this may be the perfect tool, the need to grow the SIB market demands a more pragmatic approach. Drawing from a three-year study of SIBs, and informed by Science and Technology Studies (STS)-inspired work on valuation and the social life of methods, the article explores RCTs as both a valuation technology central to SIB design and the object of a micropolitics of valuation which has impeded market growth. It is the relationship between, and the politics of, evaluation and valuation that is a key lesson of the SIB experiment and an important insight for future research on “social investment” and other settings where methods are constitutive of financial value. (shrink)

Intervention studies with developmental samples are difficult to implement, in particular when targeting demographically diverse communities. Online studies have the potential to examine the efficacy of highly scalable interventions aimed at enhancing development, and to address some of the barriers faced by underrepresented communities for participating in developmental research. During the COVID-19 pandemic, we executed a fully remote randomized controlled trial language intervention with third and fourth grade students from diverse backgrounds across the United States. Using this as (...) a case study, we discuss both challenges and solutions to conducting an intensive online intervention through the various phases of the study, including recruitment, data collection, and fidelity of intervention implementation. We provide comprehensive suggestions and takeaways, and conclude by summarizing some important tradeoffs for researchers interested in carrying out such studies. (shrink)

Policies to combat climate change should be supported by evidence regarding their effectiveness. But what kind of evidence is that? And what tools should one use to gather such evidence? Many argue that randomized controlled trials are the gold standard when it comes to evaluating the effects of policies. As a result, there has been a push for climate change policies to be evaluated using RCTs. We argue that this push is misguided. After explaining why RCTs are (...) thought to be the gold standard, we use examples of mitigation and adaptation policies to show that RCTs provide, at best, one piece of the evidential puzzle one needs to assemble for well-supported decisions regarding climate change policies. (shrink)

Background: Family members are often required to act as substitute decision-makers when health care or research participation decisions must be made for an incapacitated relative. Yet most families are unable to accurately predict older adult preferences regarding future health care and willingness to engage in research studies. Discussion and documentation of preferences could improve proxies' abilities to decide for their loved ones. This trial assesses the efficacy of an advance planning intervention in improving the accuracy of substitute decision-making and increasing (...) the frequency of documented preferences for health care and research. It also investigates the financial impact on the healthcare system of improving substitute decision-making. Methods/DesignDyads (n = 240) comprising an older adult and his/her self-selected proxy are randomly allocated to the experimental or control group, after stratification for type of designated proxy and self-report of prior documentation of healthcare preferences. At baseline, clinical and research vignettes are used to elicit older adult preferences and assess the ability of their proxy to predict those preferences. Responses are elicited under four health states, ranging from the subject's current health state to severe dementia. For each state, we estimated the public costs of the healthcare services that would typically be provided to a patient under these scenarios. Experimental dyads are visited at home, twice, by a specially trained facilitator who communicates the dyad-specific results of the concordance assessment, helps older adults convey their wishes to their proxies, and offers assistance in completing a guide entitled My Preferences that we designed specifically for that purpose. In between these meetings, experimental dyads attend a group information session about My Preferences. Control dyads attend three monthly workshops aimed at promoting healthy behaviors. Concordance assessments are repeated at the end of the intervention and 6 months later to assess improvement in predictive accuracy and cost savings, if any. Copies of completed guides are made at the time of these assessments. DiscussionThis study will determine whether the tested intervention guides proxies in making decisions that concur with those of older adults, motivates the latter to record their wishes in writing, and yields savings for the healthcare system. Trial RegistrationISRCTN89993391. (shrink)

Objective: To systematically analyze the effectiveness of technology-based interventions for reducing loneliness in older adults.Methods: We searched relevant electronic databases from inception to April 2021, which included Cochrane Library, PubMed, Web of Science, SpringerLink, EMBASE, CNKI, and Wanfang. The following criteria were used: study design—randomized controlled trial designs, people—older adults, intervention—technology-based interventions in which a core component involved the use of technology to reduce loneliness in older adults; and outcome—reduction of loneliness level in terms of rating scale scores. (...) Two reviewers independently identified eligible studies, extracted data, and assessed the risk of bias in the included studies. A third reviewer resolved any conflicts. The Cochrane Collaboration's bias assessment tool was used to evaluate the risk of bias for the included studies, and Review Manager 5.4 software was used for the meta-analysis. A random effects model was adopted to measure estimates of loneliness reduction, and standard mean differences with a 95% confidence interval were calculated for each intervention-control contrast, and the I2 statistic was applied to examine heterogeneity.Results: A total of 391 participants from six RCTs were included in the review. Of these, three studies were rated as low-quality, and the remaining three were rated as moderate-quality studies. The meta-analysis showed that the evidence regarding the effects on loneliness of technology-based interventions compared with control groups was uncertain, and suggested that technology-based interventions resulted in little to no difference in loneliness reduction compared to control groups. Two types of technology-based interventions were identified: smartphone-based video calls and computer-based training with Internet usage. The subgroup analysis found low-quality evidence to support the effectiveness of both intervention types.Conclusions: We found no current evidence to support that technology-based interventions were effective compared to different control conditions in reducing loneliness in older adults. This suggests that more research is needed to investigate the effects of technology-based interventions on loneliness in older adults. (shrink)

Study in the period of coronavirus disease 2019 lockdown and the effect of different exercise training programs on the quality of life dimension are limited. This randomized control study as a part of which the impact of an 8-week neuromuscular training program on the 90 healthy young individuals’ QoL after COVID-19 lockdown was assessed using a short form of the WHOQOL-BREF questionnaire comprising of four domains. The intervention group took part in a neuromuscular training program consisting of dynamic neuromuscular (...) stabilization and whole-body vibration training. In contrast, the control group did not participate in any programmed physical activity. From pre- to post-intervention test, the NT group significantly and substantially improved [mean change ] all the QoL domains, physical for 12.78 scores, psychological for 13.12 scores, social relationships for 20.57 scores, and environmental for 24.40 scores. These results suggest that the NT program could enhance QoL in young and healthy participants following COVID-19 lockdown. (shrink)

Randomized controlled trials (RCTs) are widely taken as the gold standard for establishing causal conclusions. Ideally conducted they ensure that the treatment ‘causes’ the outcome—in the experiment. But where else? This is the venerable question of external validity. I point out that the question comes in two importantly different forms: Is the specific causal conclusion warranted by the experiment true in a target situation? What will be the result of implementing the treatment there? This paper explains how (...) the probabilistic theory of causality implies that RCTs can establish causal conclusions and thereby provides an account of what exactly that causal conclusion is. Clarifying the exact form of the conclusion shows just what is necessary for it to hold in a new setting and also how much more is needed to see what the actual outcome would be there were the treatment implemented. (shrink)

BackgroundAt present, adherence to antipsychotic treatment is often poor, leading to the recurrence of symptoms. This increases the likelihood of the patient experiencing disability and thus increases the disease burden for the patient, their family, and society as a whole. However, to date, there is no clear evidence regarding the effect of medication adherence interventions on outcomes for patients with schizophrenia. Moreover, the traditional intervention methods are limited by manpower and resources in low- and middle-income countries. Recent studies have demonstrated (...) that increasing a patient’s level of self-compassion may improve their treatment adherence. Online mental health care interventions have advantages in terms of feasibility and acceptability for patients with schizophrenia. In this regard, a WeChat-based self-compassion training protocol to improve patient treatment adherence was designed in this study and will be evaluated in the future to determine its impact on patients with schizophrenia.MethodsThe protocol for the randomized controlled trial is based on the SPIRIT 2013 statement. This parallel RCT will aim to recruit 392 patients with schizophrenia who will be randomized at a 1:1 ratio into a 3-week intervention or control group. Both groups will receive routine care. The intervention group will also receive WeChat-based self-compassion training, which requires participants to complete three tasks every day, including a reading task, a meditation task, and a self-compassion journal task. The control group will receive WeChat-based psychological health education, which will only require participants to read positive articles about psychological health every day. Medication adherence, self-compassion, stigma, and social support will be measured at baseline, immediately after the intervention, and 3 weeks after the intervention. Program feasibility will be evaluated throughout the course of the study, and acceptability will be measured immediately after the intervention.Expected results:The intervention described here will address the barriers to accessing mental health care for people with schizophrenia, including patients’ desire for independent management, difficulty accessing providers, and concerns about privacy and stigma. The current study provides guidance for clinical nurses to carry out psychological intervention, with the ultimate aim of addressing the problems associated with a shortage of psychological professionals in low- and middle-income countries. (shrink)

BackgroundDepression is a prevalent condition that has a significant impact on psychosocial functioning and quality of life. The onset and persistence of depression have been linked to a variety of biological and psychosocial variables. Many of these variables are associated with specific lifestyle characteristics, such as physical activity, diet, and sleep patterns. Some psychosocial determinants have an impact on people’ health-related behavior change. These include personal factors such as sense of coherence, patient activation, health literacy, self-efficacy, and procrastination. This study (...) aims to analyze the association between the severity of depression, lifestyle patterns, and personal factors related to health behavior. It also aims to analyze whether personal factors moderate the relationship between lifestyles and depression.MethodsThis study is a secondary data analysis of baseline data collected at the start of a randomized controlled trial. A sample of 226 patients with subclinical, mild, or moderate depression from primary healthcare centers in two sites in Spain was used, and descriptive, bivariate, multivariate, and moderation analyses were performed. Depression was the primary outcome, measured by Beck II Self-Applied Depression Inventory. Lifestyle variables such as physical exercise, adherence to Mediterranean diet and sleep quality, social support, and personal factors such as self-efficacy, patient activation in their own health, sense of coherence, health literacy, and procrastination were considered secondary outcomes.ResultsLow sense of coherence, poor sleep quality, low patient activation, and sedentarism are predictors of having more depressive symptoms. Moderation analyses were not significant.DiscussionLifestyle and personal factors are related to depressive symptomatology. Our findings reveal that sense of coherence, patient’s activation level, sedentarism, and sleep quality are associated with depression. Further research is needed regarding adherence to Mediterranean diet, minutes walking per week and the interrelationship between lifestyles, personal factors, and depression. (shrink)

Depressive symptoms and disorders are major public health concerns, affecting many adolescents and young adults. Despite extensive research, depression prevention programs for youth show limited effectiveness. Moreover, the maximal potential of youth psychotherapy — on which depression prevention programs are based — may have been reached. Commercial video games may offer an engaging alternative vehicle for youth to practice emotional and social skills vital to mental health. The current study investigated the potential for the commercial video game Journey to prevent (...) the exacerbation of depressive symptoms. A pre-registered randomized controlled trial tested the effectiveness of Journey as an indicated depression prevention approach compared to a control game condition and a passive control condition. Additionally, potential action mechanisms for depression prevention using video games were examined. Participants aged 15 to 20 years old with elevated depressive symptoms were given 4 weeks to play Journey or the control game, Flower. Results showed no beneficial effects of playing the commercial video game, Journey, on youth’s change in depressive symptoms above and beyond the active and passive control conditions up to 12-months after the intervention. Additionally, no action mechanisms were found specifically for Journey. Nevertheless, over the whole study, participants decreased in depressive symptoms, became less sensitive to rejection, and experienced more hope and optimism. Moreover, participants who during the study decreased in rejection sensitivity or rumination or who increased in hope and optimism or in distraction and problem solving showed the strongest decrease in depressive symptoms. Although results do not support the use of the studied commercial game as an effective indicated depression prevention strategy, our results do suggest that rejection sensitivity, hope, optimism, rumination, distraction, and problem solving are promising targets for future depression prevention efforts. We conclude with important lessons for future research on games to promote mental health. Particularly, encouraging careful consideration of research designs to explore for whom and how potential action mechanisms and associated game mechanics may be effective. (shrink)

Background Ethical decision‑making and behavior of nurses are major factors that can affect the quality of nursing care. Moral development of nurses to making better ethical decision-making is an essential element for managing the care process. The main aim of this study was to examine and comparison the effect of training in ethical decision-making through lectures and group discussions on nurses’ moral reasoning, moral distress and moral sensitivity. Methods In this randomized clinical trial study with a pre- and post-test (...) design, 66 nurses with moral reasoning scores lower than the average of the community were randomly assigned into three equal groups (n = 22) including two experimental groups and one control group. Ethical decision-making training to experimental groups was provided through the lectures and group discussions. While, the control group did not receive any training. Data were collected using sociodemographic questionnaire, the nursing dilemma test (NDT), the moral distress scale (MDS) and the moral sensitivity questionnaire (MSQ). Unadjusted and adjusted binary logistic regression analysis was reported using the odds ratio (OR) and 95% confidence intervals. Results Adjusted regression analysis showed that the probability of increasing the nursing principle thinking (NPT) score through discussion training was significantly higher than lecture (OR: 13.078, 95% CI: 3.238–15.954, P = 0.008), as well as lecture (OR: 14.329, 95% CI: 16.171–2.005, P < 0.001) and discussion groups compared to the control group (OR: 18.01, 95% CI: 22.15–5.834, P < 0.001). The possibility of increasing moral sensitivity score through discussion training was significantly higher than lecture (OR: 10.874, 95%CI: 6.043–12.886, P = 0.005) and control group (OR: 13.077, 95%CI: 8.454–16.774, P = 0.002). Moreover, the moral distress score was significantly reduced only in the trained group compared to the control, and no significant difference was observed between the experimental groups; lecture group vs. control group (OR: 0.105, 95% CI: 0.015–0.717, P = 0.021) and discussion group vs. control group (OR: 0.089, 95% CI: 0.015–0.547, P = 0.009). Conclusions The results of this study indicate that ethical decision-making training is effective on empowerment of ethical reasoning. Whereas the group discussion was also effective on increasing the ethical sensitivity, it is recommended the training plan provided in this study to be held as workshop for all nurses in health and treatment centers and placed in curricular plan of nursing students. Registration This randomized clinical trial was registered in Iranian Registry of Clinical Trials under code (IRCT2015122116163N5) in 02/07/2016. (shrink)

This study evaluated the effects of an exergame program combined with traditional tennis training on autonomic regulation, tennis technique, gross motor skills, clinical reaction time, and cognitive inhibitory control in children. Sixty-three children were randomized into four groups and compared at baseline, 6-month immediately post intervention and at 1-year follow-up post intervention. At 6-month post intervention the combined exergame and regular training sessions revealed: higher breathing frequency, heart rate and lower skin conductance levels during exergaming; additional benefits in the (...) point of contact and kinetic chain elements of the tennis forehand and backhand technique ; negative impact on the shot preparation and the follow-through elements ; higher ball skills ; higher percentages of clinical reaction time improvement and cognitive inhibitory control improvement in both congruent and incongruent trials. The 1-year follow-up test showed no differences in the tennis technique, clinical reaction time and cognitive inhibitory control improvement between groups with the same number of trainings per week. The findings support exergaming as an additional training tool, aimed to improve important cognitive-motor tennis skills by adding dynamics to the standardized training process. Caution should be placed to planning this training, e.g., in a mesocycle, since exergaming might decrease the improvement of specific tennis technique parts of the trainees.. (shrink)

BackgroundIndividuals with early phase cognitive impairment are frequently affected by existential distress, social avoidance and associated health issues. The demand for efficient psychological support is crucial from both an individual and a societal perspective. We have developed a novel psychological intervention manual for providing a non-medical path to enhanced psychological health in the cognitively impaired population. The current article provides specific information on the randomized controlled trial -design and methods. The main hypothesis is that participants receiving PIPCI will (...) increase their psychological flexibility compared to participants in the active control group and the waiting list control group. The secondary hypotheses are that participants receiving PIPCI will improve psychological health compared to participants in the active control group and the waiting list control group.Materials and MethodsThis three-arm RCT will recruit participants from the cognitive centers at Karolinska University Hospital in Stockholm and randomize approximately 120 individuals in the early phase of cognitive impairment to either an experimental group, an active control group or a waiting list control group. Intervention outcome will be evaluated with self-report questionnaires on physical and psychological aspects of health, cognitive assessment, biological markers and health care costs. Assessments will be performed at pre- and post-intervention, as well as at a 6-month follow-up.DiscussionThe development of a potentially feasible and effective psychological intervention tailored for early phase cognitive impairment has the potential to advance the non-pharmacological intervention field. This is especially important given the extensive burden for many affected individuals and their families and the current lack of effective treatments. If the psychological intervention discussed here shows feasibility and efficacy, there is potential for far-reaching healthcare implications for patients with early cognitive impairment at risk of developing dementia.Clinical Trial RegistrationClinicalTrials.gov: NCT04356924. Date of registration: April 22, 2020. URL: https://clinicaltrials.gov/ct2/show/NCT04356924. (shrink)

Objectives: This study aimed to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) to improve subjective well-being (SWB), including evaluative, hedonic, and eudemonic well-being, and the mental component of quality of life (QOL) of working population. Methods: A literature search was conducted, using PubMed, Embase, PsycINFO, and PsycARTICLES. Eligible studies included those that were RCTs of any intervention, conducted among healthy workers, measured SWB as a primary outcome, and original articles in English. Study characteristics, (...) intervention, outcomes, and results on SWB outcomes were extracted by the investigators independently. After a brief narrative summarizing and classifying the contents of the interventions, the included outcomes were categorized into each aspect of SWB (evaluative, hedonic, and eudemonic well-being, and the mental component of QOL). Finally, the characteristics of the effective interventions for increasing each aspect were summarized, and the pooled effect of interventions on SWB was investigated by a meta-analysis. Publication bias was investigated by drawing a funnel plot and conducting Egger's test. Results: From the 5,450 articles found, 39 met the inclusion criteria for the systematic review. The interventions included in this review were classified into six categories (physical activity, ergonomics, psychological, environmental, multicomponent intervention, and others). The meta-analysis from 31 studies showed that the pooled effect of included interventions on SWB was significantly positive (standardized mean difference (SMD) = 0.51; standard error (SE) = 0.10). A funnel plot showed there were extremely large or small SMDs, and Egger's test was significant. Thus, we conducted sensitivity analysis, excluding these extreme SMDs, and confirmed that the estimated pooled effect was also significantly positive. Subgroup analyses for separate types of interventions showed the effects of psychological interventions (e.g., mindfulness, cognitive behavioral based approach, and other psychological interventions) were also significantly positive. Conclusion: The current study revealed the effectiveness of interventions for increasing SWB. Specifically, psychological interventions (e.g., mindfulness, cognitive behavioral based approach, and other psychological interventions) may be useful for improving SWB. (shrink)