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Scholars are generally aware of a lack of citizen knowledge about politics in the United States. One commonly suggested remedy is the production of nonpartisan voter guides to provide voters a simple and low-cost information source to help inform voters. One of the more significant variations across states is whether the voter guide is provided in a hard-copy format or distributed on the internet. This paper explores the results of a randomized controlled trial comparing a group of registered voters in Utah who received a hard-copy of a paper voter guide against a group registered voters who received a postcard inviting them to view their voter guide online. Results show few statistically significant differences between the paper guide group and the postcard group in knowledge and turnout, and those that are observed slightly favor the postcard/online group. [ABSTRACT FROM AUTHOR]

This paper reviews the literature on comparing online and paper course evaluations in higher education and provides a case study of a very large randomised trial on the topic. It presents a mixed but generally optimistic picture of online course evaluations with respect to response rates, what they indicate, and how to increase them. The paper presents a case study of 1 university and finds that means for paper course evaluations tend to be higher than for online evaluations, that the standard deviations of online evaluations are typically larger than for paper evaluations, that online evaluations take longer to complete than their paper counterparts, that students prefer online evaluations, and that factor analysis shows similar and different numbers of factors for the 2 types of evaluation, even with the same instrument and the same population. Caution is advocated in assuming that the same online and paper evaluations yield similar results. [ABSTRACT FROM AUTHOR]

In-clinic follow-up to assess completion of medical abortion is no longer a requirement according to World Health Organization guidance, provided adequate counselling is given. However, timely recognition of ongoing pregnancy, complications or incomplete abortion, which require treatment, is important. As part of a larger trial, this study aimed to establish whether women having a medical abortion could self-assess whether their abortion was complete using an automated, interactive questionnaire on their mobile phones. All 469 participants received standard abortion care and all returnees filled in a self-assessment on paper at clinic follow-up 2–3 weeks later. The 234 women allocated to receive the phone messages were also asked to do a mobile phone assessment at home ten days post-misoprostol. Completion of the mobile assessment was tracked by computer and all completed assessments, paper and mobile, were compared to providers’ assessments at clinic follow-up. Of the 226 women able to access the mobile phone assessment, 176 (78%) completed it; 161 of them (93%) reported it was easy to do so. Neither mobile nor paper self-assessments predicted all cases needing additional treatment at follow-up. Prediction of complete procedures was good; 71% of mobile assessments and 91% of paper assessments were accurate. We conclude that an interactive questionnaire assessing completion of medical abortion on mobile phones is feasible in the South African setting; however, it should be done later than day 10 and combined with an appropriate pregnancy test to accurately detect incomplete procedures. [ABSTRACT FROM AUTHOR]

Objectives. Test-retest reliability of an asthma paper diary versus an electronic diary (e-diary) with an integrated peak flow meter was investigated. The equivalence of the two modes was also evaluated. Methods. Prospective, randomized crossover study design in adolescents (12-17 years) and adults (≥18 years). Key inclusion criteria were persistent asthma, Asthma Control Test (ACT) scores ≥16, use of inhaled corticosteroid with or without long-acting beta-agonist for ≥12 weeks, nocturnal awakenings <2 times in the past week, and activity limitations <1 per week. Participants were randomized to either paper then e-diary or e-diary then paper, to be completed for 14 days each. Results. Forty-seven participants completed all study visits. Weekly percentage of symptom-free days (SFDs) and rescue-free days (RFDs) were calculated. Intraclass correlation coefficients (ICCs) of Week 1 mean SFD and RFD (test) and Week 2 mean SFD and RFD (retest), respectively, were estimated in three groups defined as stable: (i) minimal changes in asthma symptoms, as measured by the global patient reported symptom change question, (ii) less than 15% change (absolute value) in 1 second FEV1 at adjacent study visits, and (iii) changes in ACT scores less than three points for each mode. SFD demonstrated acceptable ICC (≥0.70) using all three definitions of asthma stability for both modes. Conclusion. Acceptable reproducibility of the percentage of RFD (ICC = 0.78) was only observed for the e-diary using the FEV1 stability criterion. The ICCs for SFD and RFD were acceptable, 0.84 and 0.70, respectively, suggesting better reliability for the e-diary. [ABSTRACT FROM AUTHOR]

Objective: Patient-reported mood charts are frequently used in management of bipolar disorder. Although mood charts have recently been programmed in electronic devices such as mobile phones, little is known about the impact of the method of data capture on the psychometric properties and validity of these data. Methods: In an ongoing pilot study, a sample of outpatients with bipolar disorder were randomized to complete mood charts either on a mobile phone or with standard paper and pencil as part of a 12-week intervention (primary outcomes for the trial await study completion). We compared these conditions across a single item rating of mood state, and we hypothesized that mobile phone-based data capture would produce greater compliance to mood ratings, variability between and within participants, and concurrent validity with blinded clinician-rated affective symptom severity. Results: A total of 56 participants were randomized and 40 participants were included in the analyses. There were no significant differences between conditions on demographic or clinical variables. The rate of compliance was significantly higher in paper-and-pencil versus mobile phone ratings. Ratings demonstrated significantly more variability within individuals in the mobile phone condition. Mobile phone mood ratings were significantly correlated with clinician-rated depressive symptom severity across the study and with manic symptom severity at the week-6 assessment, whereas paper-and-pencil ratings were not significantly associated with clinician-rated depression or mania. Conclusions: Although preliminary, our results suggest a lower rate of compliance with mobile phones compared to paper-and-pencil daily mood rating in bipolar disorder, yet a greater ability to capture variability and concurrent validity in quantifying affective symptoms. This clinical trial is registered at www.clinicaltrials.gov as NCT01670123. [ABSTRACT FROM AUTHOR]

Objectives: To compare data based on computerized and paper versions of health status questionnaires (HSQs) for sampling patient-reported outcomes (PROs) in patients with fibromyalgia (FM). In addition, to examine associations between patient characteristics (age, education, computer experience) and differences between versions. Finally, to evaluate the acceptability of computer-based questionnaires among patients with FM.Method: The study population comprised female patients diagnosed with FM. All patients completed six HSQs: the Fibromyalgia Impact Questionnaire (FIQ), the Major Depression Inventory (MDI), the 36-item Short Form Health Survey (SF-36), the painDETECT questionnaire (PDQ), the Coping Strategies Questionnaire (CSQ), and the Generalized Anxiety Disorder Self-Assessment Questionnaire (GAD-10), both on paper and using a touch screen. One HSQ was tested at a time in a repeated randomized cross-over design. The two versions were completed with a 5-min interval and between each HSQ the participants had a 5-min break. Means, mean differences with 95% confidence intervals (CIs), medians, median differences, and intraclass correlation coefficients (ICCs) were calculated for all HSQs, including relevant subscales. Associations between patient characteristics and differences between versions were explored using Spearman's correlation coefficients.Results: Twenty women, mean age 48.4 years, participated in the study. Except for one item, ICCs between touch-screen and paper versions of the HSQs examined indicated acceptable agreement (ICC = 0.71-0.99). Overall, mean and median differences revealed no differences between versions. No significant associations were observed for patient characteristics. None of the participants preferred paper questionnaires over computerized versions.Conclusions: The computerized HSQs using a touch screen gave comparable results to answers given on paper and were generally preferred by the participants. [ABSTRACT FROM AUTHOR]

Evaluation of: Koren MJ, Giugliano RP, Raal FJ et al.; OSLER Investigators. Efficacy and safety of longer-term administration of evolocumab (AMG 145) in patients with hypercholesterolemia: 52-week results from the Open-Label Study of Long-Term Evaluation Against LDL-C (OSLER) randomized trial. Circulation 29(2), 234-243 (2014). PCSK9 degrades LDLR after almost 30 h of function. The OSLER trial tested the mid-term (1 year) safety and efficacy of evolocumab, a human antibody against PCSK9, which prolongs the function of LDLR and reduces LDL-cholesterol (LDL-C) levels. The study included 1104 patients with hypercholesterolemia, after the completion of four different Phase II studies. Regardless of treatment in the parent studies, patients were randomized to subcutaneous evolocumab 420 mg/4 weeks plus standard care including statins (n = 736), or standard care alone (n = 368). Patients who first received evolocumab in OSLER and those on evolocumab in the parent studies had an identical mean decrease (52%) in LDL-C at week 52 (p < 0.0001). In those who discontinued evolocumab on entry into OSLER LDL-C levels returned to baseline levels. In subjects on evolocumab, 96% achieved LDL-C <2.9 mmol/l (100 mg/dl) at any visit vs 32% of participants on standard care, while LDL-C <1.8 mmol/l (70 mg/dl) was achieved in 83 vs 4%, respectively. A total of 2.2% of patients on standard care and 1.2% patients on evolocumab experienced a cardiovascular event. The discontinuation rate of evolocumab due to adverse effects was 3.7%, suggesting excellent safety. These results suggest that evolocumab is safe and effective on a mid-term basis. [ABSTRACT FROM AUTHOR]

The Cumberland Ankle Instability Tool is a common patient reported outcome used to assess those with Chronic Ankle Instability. However, paper versions of the Cumberland Ankle Instability Tool have only been assessed for reliability purposes. The purpose of this study was to assess the agreement and reliability of a digital version of the Cumberland Ankle Instability Tool-Digital. Sixty-eight participants with a history of ankle sprain(s) were recruited to participate in this study. Participants completed a paper version of the Cumberland Ankle Instability Tool and a digital version then returned one week later and completed them again. Intraclass correlation coefficients (ICC) and Kappa coefficients were used to determine the agreement between the paper and digital versions as well as test-retest reliability between the two time periods. The digital version showed excellent reliability (ICC = 0.93, 95% CI: 0.89–0.96) with the paper version. The test-retest reliability between testing sessions was considered good (ICC = 0.86, 95% CI: 0.77–0.92). A majority of individual items on the digital version demonstrated substantial agreement (κ = 0.60–0.81) with the paper version. A digital version of the Cumberland Ankle Instability Tool demonstrated good to excellent psychometric properties. Clinicians who utilize a digital version as part of an electronic medical record system can utilize them confidently to accurately assess patients with Chronic Ankle Instability. Future studies may want to consider assessing a digital version with expanded clinical and research populations. The digital version of the Cumberland Ankle Instability Tool demonstrated adequate psychometric properties. The digital version of the Cumberland Ankle Instability Tool can be considered a reliable instrument for the assessment of Chronic Ankle Instability. A digital version of the Cumberland Ankle Instability Tool can provide automated scoring and quick administration for clinicians in a rehabilitation setting. [ABSTRACT FROM AUTHOR]

This paper introduces a simple, quotient effect size, termed q (for 'quotient'), suitable for reporting on the effectiveness of educational interventions. The quotient effect size for a pre-test-post-test design is defined as the gain score (i.e. post-test minus pre-test) for the intervention group, divided by the gain score for the control group. This quotient effect size measure is easy to calculate and interpret, and, like Cohen's d , is scale-free. However, it achieves scale independence without acquiring the well-reported difficulties that arise with standardized effect sizes, such as Cohen's d , as a result of incorporating the standard deviation. Since the standard deviation is sensitive to many factors that are unrelated to 'the effect', Cohen's d is not a pure measure of 'effect'. By contrast, the quotient effect size, q , is dimensionless, without needing to involve the standard deviation, and is consequently intuitively easy to comprehend and communicate. For example, a q of 1.2 would mean that the intervention group improved by 20% more than the control group did. This paper explores the advantages of using q as an effect size for reporting on the effectiveness of educational interventions, as compared with Cohen's d , and addresses some possible objections. [ABSTRACT FROM AUTHOR]

Acquiring information about one's child's cancer diagnosis is a complex and ever-changing process, and parents' needs change over time. As yet, we know little about what information parents require at different stages of their child's illness. This paper is part of a larger randomized control trial studying the parent-centered information given to mothers and fathers. The aim of this paper was to describe the topics addressed in person-centered meetings between nurses and parents of children with cancer and how those changed over time. Using qualitative content analysis, we analyzed nurses' written summaries of 56 meetings with 16 parents and then computed for each topic the percentage of parents who brought it up at any time during the intervention. The main categories were Child's disease and treatment (addressed by 100% of parents), Consequences of treatment (88%), Emotional management for the child (75%), Emotional management for the parent (100%), Social life of the child (63%), and Social life of the parent (100%). Different topics were addressed at different points in time, and fathers raised more concerns about the child's emotional management and the consequences of treatment than mothers. This paper suggests that parental information demands change over time and differ between fathers and mothers, implying that information should be person-centered. Registered at Clinicaltrials.gov (NCT02332226). [ABSTRACT FROM AUTHOR]

In recent years, web marketing has thrived, and online coupon distribution has become a significant marketing measure that leads to increased sales. However, randomly distributing coupons risks lowering the profit ratio of companies. Therefore, it is important to estimate the effect of coupons and analyze the causal relationship between coupons and results. The potential purchase intention (PPI) of users is believed to influence the effect of coupons. For example, distributing coupons to users with a low PPI is likely to increase the gross profit of companies, whereas distributing coupons to users with a high PPI is likely to decrease the gross profit. Therefore, by analyzing the relationship between PPI and the effect of coupons, highly effective targeting can be conducted based on the PPI. In this paper, we propose an experimental design based on machine learning to analyze the effect of coupons, which varies depending on the PPI. We propose a method to predict users' PPI based on their purchase history data using machine learning and analyze the relationship between PPI and the effect of coupons. Finally, we demonstrate the effectiveness of the proposed framework by applying it to real-world data. [ABSTRACT FROM AUTHOR]

Purpose: For individuals with atopic dermatitis (AD), interpreting scientific papers that present clinical outcomes including the Eczema Area and Severity Index (EASI) and Investigators Global Assessment may be difficult. When compared to tabulated data and graphs, images from before and after treatment are often far more meaningful to these patients that ultimately will be candidates for the treatment. This systematic review focused on determining the frequency of clinical image sharing in AD research. Materials and methods: Conducted in accordance with PRISMA guidelines, the review concentrated on randomized controlled trials that investigated predefined and available systemic treatments for AD. The search was performed in the MEDLINE database for studies published from the inception until 21 December 2023. Results: The review included 60 studies, encompassing 17,799 randomized patients. Across these studies, 16 images representing 6 patients were shared in the manuscripts, leading to a sharing rate of 0.3‰. Conclusions: The almost missing inclusion of patient images in clinical trial publications hinders patient understanding. Adding images to scientific manuscripts could significantly improve patients’ comprehension of potential treatment outcomes. This review highlights the need for authors, the pharmaceutical industry, study sponsors, and publishers to enhance and promote patient information through increased use of visual data. [ABSTRACT FROM AUTHOR]

The article discusses the article "Inefficacy Interim Monitoring Procedures in Randomized Clinical Trials: The Need to Report," by E. L. Korn and B. Freidlin. In the article the authors offer their opinions on clinical trials and on several assertions and results which are found in Korn and Freidlin's article.

Students in protracted crisis settings often face a range of challenges which combine to yield low education outcomes. This paper presents the results from a randomised controlled trial of weekend and holiday booster classes for 7th and 8th grade girls in Kakuma refugee camp in Kenya, that aimed to improve girls' education outcomes and increase transition rates from primary to secondary school. While qualitative results suggested numerous advantages of the booster classes, including more freedom to ask questions, smaller class sizes, and kinder teachers, the program did not yield statistically significant effects on learning outcomes, school attendance or noncognitive skills. Mixed-methods research suggests that the limited impacts may stem from implementation challenges including irregular booster class attendance and a lack of appropriate teaching materials. More broadly, the results show the importance of accounting for implementation challenges in the reporting of impact evaluation results. [ABSTRACT FROM AUTHOR]

Objectives: (1) To evaluate the effects of a platelet-rich fibrin (PRF) membrane in the repair of traumatic tympanic membrane (TM) perforations; and (2) to compare the use of a PRF membrane with the paper patch technique with regard to recovery rates, healing time, and correction of the mean air-bone gap. Methods: A randomized, prospective analysis was performed for 60 patients who were treated for traumatic TM perforations using one of the two methods. Closure rate, speed of healing, and hearing gain were compared between the PRF (Group 1) and paper patch (Group 2) groups. Results: Closure was obtained in 28 (93%) perforations in Group 1 and 25 (83%) perforations in Group 2 (p>0.05). On day 10, full closure of the TM was observed in 24 (80%) patients in Group 1 and 16 (53%) patients in Group 2 (p<0.05). The improvement in the mean air-bone gap was 14.1 dB in Group 1 and 12.4 dB in Group 2 on post-operative day 45 (p<0.05). Conclusions: In comparison with the paper patch method, PRF, a new method, provided more rapid healing with more successful audiological results, and with no requirement for a second procedure. [ABSTRACT FROM AUTHOR]

HIV vaccine trials with minors will likely require parental permission and informed assent from adolescents. For this to be a valid process, the information needs to be presented in a manner that promotes adolescent comprehension. Previous studies suggest that adolescent comprehension of assent is often insufficient. We developed an interactive web-based assent that included interspersed quiz questions for a hypothetical HIV vaccine trial. Efficacy of the web-based assent was compared to a standard paper assent with and without interspersed questions. One hundred twenty teen participants, ages 15–17 years, from five community organizations were randomized to self-administered web-based assent (n= 60) or investigator-administered paper assent with (n= 29) or without (n= 31) interspersed quiz questions. After reviewing the assent, participants completed a 27-item comprehension test. Comprehension scores were compared between groups. The mean number of correctly answered questions were 21.2 for the full paper group and 21.1 for the web-based group (t118= –0.08,p= 0.94). Scores were 20.2 for the paper without interspersed questions sub-group and 22.1 for the paper with interspersed questions sub-group (t58= 1.96,p= 0.055). Participants in the web-based group performed as well on the comprehension test as those in the paper group, and those in the paper with questions sub-group performed better than those in the paper without questions sub-group, suggesting that interspersed quiz questions may improve understanding of a traditional paper assent. The minimal investigator time and standardized administration of the web-based assent as well as ability to tailor the assent discussion to topics identified by incorrect comprehension test responses are advantages worthy of further investigation. [ABSTRACT FROM AUTHOR]

To evaluate the quality of reporting in published randomized controlled trials (RTCs) in the field of fall injuries. The 188 RTCs published between 2001 and 2011, indexed in EMBASE and Medline databases were extracted through searching by appropriate keywords and EMTree classification terms. The evaluation trustworthiness was assured through parallel evaluations of two experts in epidemiology and biostatistics. About 40%-75% of papers had problems in reporting random allocation method, allocation concealment, random allocation implementation, blinding and similarity among groups, intention to treat and balancing benefits and harms. Moreover, at least 10% of papers inappropriately/not reported the design, protocol violations, sample size justification, subgroup/adjusted analyses, presenting flow diagram, drop outs, recruitment time, baseline data, suitable effect size on outcome, ancillary analyses, limitations and generalizability. Considering the shortcomings found and due to the importance of the RCTs for fall injury prevention programmes, their reporting quality should be improved. [ABSTRACT FROM AUTHOR]

Although the Insomnia Severity Index (ISI) is already administered online, this frequently used instrument has not been validated for Web delivery. This study compares online and paper-and-pencil ISI versions completed by participants in a randomized controlled trial testing an Internet-delivered intervention for insomnia. Forty-three adults with insomnia completed both ISI versions during pre- (Assessment 1) and post-intervention (Assessment 2). Correlations between total scores of both versions were significant (rs ≥ .98, ps < .001). For both ISI versions, internal consistency was acceptable (Assessment 1, α = .61; Assessment 2, α ≥ .88). Among participants not receiving the parent study intervention, correlations between 1 format at Assessment 1 and the alternative format at Assessment 2 were generally significant (rs = .26–.82). Together, findings suggest the ISI can be delivered online. [ABSTRACT FROM AUTHOR]

To correctly evaluate the effects of treatments, conducting randomized controlled trials (RCTs) is a reasonable approach. However, because it is generally difficult to implement RCTs for all treatments, methods to estimate the treatment effects using observational data have been actively studied and used in various decision-making processes. Observational data accumulated in business activities and elsewhere contains the results of various previously implemented treatments, and correctly estimating the effects of any given treatment without separating the impacts of other treatments is challenging. Against this background, this paper proposes a method to estimate the effects of multiple treatments of various types while considering various causal relationships. Specifically, the proposal is a variational inference method that estimates the effect of multiple treatments using four latent factors estimated from observations, making assumptions that are independent of the type and number of treatments. The proposed method makes it possible to appropriately estimate the effects of measures even in situations with complex causal relationships. In addition, in situations where measures with continuous parameters are being implemented, it is possible to estimate the effects of measures that have not been implemented in the past by treating the content of the measures as a continuous variable. [ABSTRACT FROM AUTHOR]

Copyright of European Journal of Psychotraumatology is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

The Lighthouse Parenting Programme (LPP) is a multifamily mentalization-based intervention for parents with child protection service involvement. The Supporting Parents Project was a randomized controlled trial of the LPP being delivered by children's social care services. In this paper, the research and clinical leads of the project present some of their early findings and thinking in relation to parental mentalizing in this context. Early findings from the study showed unexpected results in relation to the assessment of parental reflective functioning. Issues around the measurement of parental mentalizing, and particularly pre-mentalizing modes, are discussed. We argue that learning from clinicians with experience of supporting parents through a mentalization-based approach can help researchers become more nuanced in their assessments. In the second half of the paper, we present some of the metaphors and imagery used in the LPP that has proven useful in helping parents and frontline practitioners to establish epistemic trust and methods for enhancing parental mentalizing. [ABSTRACT FROM AUTHOR]

This paper explores how Chinese academics, working in the field of English as Foreign Language Education in universities in China, conceptualise research quality. The paper uses a phenomenological approach and four qualitative methods (survey, interview, focus groups and document analysis) to investigate what a sample of these scholars perceive as high-quality research. We found that the participants viewed quality through various lenses and identified several different criteria. We categorised their elaboration of the criteria under three headings: methodology, contextualisation and impact. The participants nominated many general criteria that were similar to western standards of research quality, especially in relation to methodology; however, some contextual criteria were specific to the Chinese context. The paper indicates that there is much in the university research community that could be altered to enable people who are directly involved in research to disseminate their criteria for research quality, and potentially to affect and develop the quality of educational research in the Chinese context, and/or elsewhere. [ABSTRACT FROM AUTHOR]

Chronotherapeutic interventions for bipolar depression and mania are promising interventions associated with rapid response and benign side effect profiles. Filtering of biologically active short wavelength (blue) light by orange tinted eyewear has been shown to induce antimanic and sleep promoting effects in inpatient mania. We here describe a study protocol assessing acute and long-term stabilizing effects of blue blocking (BB) glasses in outpatient treatment of bipolar disorder. A total of 150 outpatients with bipolar disorder and current symptoms of (hypo)-mania will be randomized 1:1 to wear glasses with either high (99%) (intervention group) or low (15%) (control group) filtration of short wavelength light (<500 nm). Following a baseline assessment including ratings of manic and depressive symptoms, sleep questionnaires, pupillometric evaluation and 48-h actigraphy, participants will wear the glasses from 6 PM to 8 AM for 7 consecutive days. The primary outcome is the between group difference in change in Young Mania Rating Scale scores after 7 days of intervention (day 9). Following the initial treatment period, the long-term stabilizing effects on mood and sleep will be explored in a 3-month treatment paradigm, where the period of BB treatment is tailored to the current symptomatology using a 14-h antimanic schedule during (hypo-) manic episodes (BB glasses or dark bedroom from 6 PM to 8 AM) and a 2-h maintenance schedule (BB glasses on two hours prior to bedtime/dark bedroom) during euthymic and depressive states. The assessments will be repeated at follow-up visits after 1 and 3 months. Throughout the 3-month study period, participants will perform continuous daily self-monitoring of mood, sleep and activity in a smartphone-based app. Secondary outcomes include between-group differences in actigraphic sleep parameters on day 9 and in day-to-day instability in mood, sleep and activity, general functioning and objective sleep markers (actigraphy) at weeks 5 and 15. The trial will be registered at prior to initiation and has not yet received a trial reference. The current paper is based on protocol version 1.0_31.07.23. Trial sponsor: Lars Vedel Kessing. [ABSTRACT FROM AUTHOR]

It is not uncommon for randomised trials in education to have the performance of sample members in national examinations as their primary outcome. In many cases, examination results are available as summary measures only. Taking the example of GCSE examination results in England, this paper shows that using summary measures of an underlying score or mark, such as exam grade, complicates the design of trials and can lead to underpowered studies. Simple simulations are used to explore the consequences of powering trials to detect a difference assuming grade or summary measures are the only outcome metric available, where the effects of an intervention are primarily captured in the unknown mark or score distribution. The analysis draws on data that relate the entire distribution of marks in English language and mathematics examinations to grades. Recommendations are made in order to address this problem. [ABSTRACT FROM AUTHOR]

Serum creatinine level are influenced by many factors. Although accumulated data suggested that prebiotics, probiotics and synbiotics supplements could affect serum creatinine level, the results remained controversial. The aim of the present paper was to evaluate the effects of prebiotics, probiotics and synbiotics on serum creatinine in non-dialysis patients. PubMed, EMBASE (Excerpta Medica Database) and the Cochrane Library databases were searched for eligible randomized, controlled trials (RCTs) which were limited to English language studies until 30 September 2022. A random-effects model was performed to analyze the impact of pooled trials. Twelve randomized, controlled trial studies were included in the meta-analysis. Prebiotics, probiotics or synbiotics supplementation did not significantly decrease the serum creatinine levels in non-dialysis patients compared to placebo [standardized mean difference (SMD) = 0.05; 95% confidence interval (CI): (−0.21, 0.31); p = 0.72; I2 = 61%]. The present meta-analysis indicated that supplementation with prebiotics, probiotics and synbiotics could not act as promising adjuvant therapies to decrease the serum creatinine levels in non-dialysis patients. [ABSTRACT FROM AUTHOR]

Copyright of European Journal of Psychotraumatology is the property of Taylor & Francis Ltd and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Ainsworth et al.’s paper “Sources of Bias in Outcome Assessment in Randomised Controlled Trials: A Case Study” examines alternative accounts for a large difference in effect size between 2 outcomes in the same intervention evaluation. It argues that the probable explanation relates to masking: Only one outcome measure was administered by those aware of participants’ treatment assignment. This paper shows this conclusion is not substantiated by the evidence: The original paper fails to exclude alternative explanations, and what it takes as positive evidence for the preferred explanation is actually negative. While accepting the importance of masking in randomised controlled trials, this paper concludes that the original question was based on a misconception about effect sizes: Seen correctly as a measure of whole study design, the question of effect size difference between different outcome measures does not need asking. [ABSTRACT FROM AUTHOR]

In the biomedical, behavioural and social sciences, the leading method used to estimate causal effects is commonly randomised controlled trials (RCTs) that are generally viewed as both the source and justification of the most valid evidence. In studying the foundation and theory behind RCTs, the existing literature analyses important single issues and biases in isolation that influence causal outcomes in trials (such as randomisation, statistical probabilities and placebos). The common account of biased causal inference is described in a general way in terms of probabilistic imbalances between trial groups. This paper expands the common account of causal bias by distinguishing between the range of biases arising between trial groups but also within one of the groups or across the entire sample during trial design, implementation and analysis. This is done by providing concrete examples from highly influential RCT studies. In going beyond the existing RCT literature, the paper provides a broader, practice-based account of causal bias that specifies the between-group, within-group and across-group biases that affect the estimated causal results of trials – impacting both the effect size and statistical significance. Within this expanded framework, we can better identify the range of different types of biases we face in practice and address the central question about the overall validity of the RCT method and its causal claims. A study can face several smaller biases (related simultaneously to a smaller sample, smaller estimated effect, greater unblinding etc.) that generally add up to greater aggregate bias. Though difficult to measure precisely, it is important to assess and provide information in studies on how much different sources of bias, combined, can explain the estimated causal effect. The RCT method is thereby often the best we have to inform our policy decisions – and the evidence is strengthened when combined with multiple studies and other methods. Yet there is room for continually improving trials and identifying ways to reduce biases they face and to increase their overall validity. Implications are discussed. [ABSTRACT FROM AUTHOR]

It was in the 1990s, that the possibility of increased transmission of HIV with the use of injectable contraceptive Depo-Provera®, was first flagged in medical literature. This has posed a challenge for its use in countries, particularly in the African region, where the prevalence and transmission rate of HIV is high. In 2015, a randomised 'clinical' trial, the Evidence for Contraceptive Options and HIV Outcomes (ECHO) was launched in four African countries to resolve the question whether the increased risk was causal. Contrary to expectations, the ECHO trial successfully recruited and randomised the specified number of girls/women participants. This paper argues that this was made possible by exercising undue influence, by using incentives, coercive language, and by concealing the real nature of the clinical trial during recruitment. The ECHO trial is unique in subjecting a group of healthy girls/women knowingly to a contraceptive drug with an intention not of finding out whether it is efficacious as a contraceptive, but to find out how risky or life-threatening its use could be. Thus, the ECHO trial has violated one of the central tenets of the Helsinki Declaration by privileging pursuit of knowledge over the interests of the girl/women trial participants from Africa. [ABSTRACT FROM AUTHOR]

Introduction: Nonadherence to antiseizure medications (ASMs) is associated with increased mortality, morbidity, health care utilization, and costs. Areas covered: This article reviewed 18 randomized controlled trials published between Jan 2010 and Feb 2024 on Medication Adherence Enhancing Intervention (MAEI) for people with epilepsy. The adequacy of reporting intervention development process was assessed using the GUIDance for the rEporting of intervention Development (GUIDED). The adequacy of the intervention description was assessed using the Template for Intervention Description and Replication (TIDieR) checklist. The interventions were categorized as educational (n = 7), behavioral (n = 5), or mixed (n = 6). The impact of MAEIs on adherence is mixed with majority of studies either reporting no difference between intervention and control groups (n = 6) or improvement in the intervention group (n = 7). The shortcomings in the reporting of MAEIs development, MAEIs description, and MAEIs impact measurement were discussed. Expert opinion: Future research needs to accomplish the following tasks: 1) develop and test valid epilepsy-specific self-report measures for assessing adherence; 2) optimize intervention design; and 3) increase transparency in reporting all stages of research. [ABSTRACT FROM AUTHOR]

An introduction to the journal is presented in which discusses the standard and experimental designs of randomized control trials (RCTs), the effectiveness of Programme for Functional Literacy for language and mathematics students, and the use of random forest method for education research.

Methods to extend the strong internal validity of randomized controlled trials to reliably estimate treatment effects in target populations are gaining attention. This paper enumerates steps recommended for undertaking such extended inference, discusses currently viable choices for each one, and provides recommendations. We demonstrate a complete extended inference from a clinical trial studying a pharmaceutical treatment for Alzheimer's disease (AD) to a realistic target population of European residents diagnosed with AD. This case study highlights approaches to overcoming practical difficulties and demonstrates limitations of reliably extending inference from a trial to a real-world population. [ABSTRACT FROM AUTHOR]

This study aimed to determine how watching lecture videos at 1× and 2× speeds affects memory retention in medical students. A posttest-only experimental design was utilized. The participants were 60 Year-1 and Year-2 medical students. The participants were assigned to one of two groups through stratified randomization: Group 1 would watch the video at 1× speed, and Group 2 at 2× speed. Their performance was assessed using a test comprising 20 multiple-choice questions. The test has been applied immediately after watching the video (Immediate test), and, again after one week (Delayed test). Parametric and non-parametric statistical tests were performed. In the Immediate test, the mean score of the 1× speed group was 11.26 ± 4.06, while 2× speed group's mean score was 10.16 ± 2.46. The difference was not significant t(58) = 1.26, p >.05. In the Delayed test, the mean score of 1× speed group was 9.66 ± 3.94, while 2× speed group's mean score was 8.36 ± 2.80. The difference was not significant t(55) = 1.42, p >.05. Watching the video lecture at 2× speed did not impair memory retention in medical students. This may help students to save time in their dense curricula. Practice points Many medical students watch lecture videos at 2× (double) speed to save time. While this is a time-saver, the negative impact on their learning is unclear. This paper describes a randomized trial that measures the learning impact when medical students watch an instructional video at 2× speed and finds that there is no significant negative impact on their learning. [ABSTRACT FROM AUTHOR]

This paper summarizes results from an impact study that employed a randomized controlled trial to estimate the efficacy of a cross-age peer mentor program designed to prevent school dropout during the transition from middle to high school. We present findings from the intent-to-treat (ITT) analyses, which included 1,351 ninth-grade students, alongside those of two different methods that estimate the complier average causal effect (CACE) of participating in the program. Although the confirmatory study, which investigated impact on attendance and credit accrual in ninth grade, was null, ITT analyses on exploratory outcomes indicate modest, yet potentially meaningful program impact on ninth-grade outcomes of discipline, school attachment, and expectations of degree attainment across varying dosage levels. CACE estimates also suggest that a threshold level of program participation broadens the program's impact on additional exploratory academic achievement and social and emotional learning outcomes. Given the adverse effects of the transition to high school, this promising evidence indicates that the cross-age peer mentoring intervention could be an effective strategy for high schools to implement that leverages existing staff and students. [ABSTRACT FROM AUTHOR]

Most Chinese pre-arrival training programs are focused on English language training without preparing students with psychological readiness to overcome potential adversities. This paper explores the effectiveness of an innovative six-week pre-arrival training program that integrated English training with resilience training through the lens of social constructionism. The program involved a mix of English proficiency training using stories with an underlying resilience theme coupled with further reinforcement of resilience skills through interactive narratives, bibliotherapy and art therapy. Thirty Chinese students who were enrolled in a joint venture training program between China and the U.K. were randomly divided into an experimental group and a control group. The result of the pretest and posttest comparison after students participated in the training program showed a significant improvement in the experimental group's overall English skills and resilience, and a decrease in their anxiety, stress, and depression compared to the control group. [ABSTRACT FROM AUTHOR]

Purpose: Postmicturition dribbling (PMD) is a stressful symptom in middle-aged men characterized by urinary leakage after the completion of normal voiding. Appropriate treatments have not yet been introduced. This study assessed the efficacy of treatment of PMD with 75 mg udenafil daily.Materials and Methods: The study included 138 men with regular sexual lifestyles. The Hallym PMD questionnaire (HPMDQ) was used to assess PMD symptoms. After all basic examinations, patients were randomly assigned to either udenafil or placebo. Patients completed the surveys, uroflowmetry (UFM), a bladder scan, and the paper test during the follow-up visit.Results: The mean age of the patients was 57.6 years. PMD with one of every three urinations was experienced by 59 patients (42.8%), whereas 45 patients (32.6%) experienced PMD with two of every three urinations. PMD with every urination was experienced by 34 patients (24.6%). More than half of the patients (89 patients, 65.4%) indicated that persistent PMD symptoms would likely result in moderate to severe discomfort in their daily activities. As time passed, the udenafil group showed significant improvement in PMD symptoms (p = 0.001).Conclusion: Udenafil 75 mg once daily can be an effective treatment for patients with PMD symptoms. [ABSTRACT FROM AUTHOR]

Introduction: Originally, the Asthma Control Test (ACT) was designed for English-speaking patients using a paper-and-pencil format. The Turkish version of the ACT was recently validated. This article compares the paper-and-pencil and web-based texting formats of the Turkish version of the ACT and evaluates the compatibility of these ACT scores with GINA-based physician assessments of asthma control. Methods: This multicentre prospective study included 431 asthma patients from outpatient clinics in Turkey. The patients were randomized into a paper-and-pencil group ( n = 220) and a text messaging group ( n = 211). Patients completed the ACT at Visit 1, after 10 ± 2 days, and at 5 ± 1 week to demonstrate the reliability and responsiveness of the test. At each visit, physicians assessed patients' asthma control levels. Results: The ACT administered via texting showed an internal consistency of 0.82. For the texting group, we found a significant correlation between the ACT and physician assessments at Visit 1 ( r = 0.60, p < 0.001). The AUC was 0.87, with a sensitivity of 78.0% and a specificity of 77.5% for a score of ≤19 for screening 'uncontrolled' asthma in the texting group. Conclusion: When the Turkish version of the ACT was administered via either the paper-and-pencil or text messaging test, scores were closely associated with physician assessments of asthma control. [ABSTRACT FROM AUTHOR]

A randomised controlled trial (RCT) of a mindfulness-based yoga program, MiYoga, for cerebral palsy (CP) demonstrated improved attention in children and decreased mindfulness in parents post-intervention. This paper evaluates the retention of treatment effects at 6-months follow-up. 42 children with CP and their parents participated in a RCT with two groups MiYoga (n = 21) and Waitlist control group (n = 21). Waitlist control participants were offered MiYoga following the post-intervention assessment. 23 out of 42 child-parent dyads from both groups completed follow-up assessment 6-months after completing MiYoga. This paper evaluates and reports data from both groups collapsed (n = 23; MiYoga n = 11; and waitlist control n = 12; 47.8% male; mean age = 9:10 ± 2.4 years) to assess retention from post-MiYoga to follow-up and pre-MiYoga to follow-up. The primary outcome was attention, measured by Conner's Continuous Performance Test II (CCPT). Secondary outcomes included child executive function, physical function, behaviour, quality of life, child and parent mindfulness, personal wellbeing, psychological wellbeing and parent-child relationship. Paired t-tests showed no significant changes between post-MiYoga to follow-up and pre-MiYoga to follow-up for variables that showed an intervention effect immediately after MiYoga, namely, children's attention variables and parent's mindfulness. Paired t-tests showed that children's executive function and physical function and parent's wellbeing improved significantly from pre-MiYoga to 6-months follow-up which may potentially reflect sleeper or delayed effects of MiYoga. This study identified possible delayed or sleeper effects in children's executive function and physical function and parent's well-being. 6-month follow-up evidence for retention of effects of MiYoga on children's attention was inconsistent; therefore, booster sessions or continued practice of MiYoga as a lifestyle option are needed to maintain an effect on attention. Because MiYoga can be practised during daily activities, it may provide additional support for children with CP, complementing standard rehabilitation options. By embedding mindfulness in children and parents' daily activities, MiYoga, could provide families with accessible and time-efficient means of learning and practicing mindfulness. [ABSTRACT FROM AUTHOR]

Copyright of European Journal of Social Work is the property of Routledge and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This paper provides a political-economic analysis of policy evaluation. We focus on Randomized Controlled Trials (RCTs) as a subset of policy evaluations and argue that they are used instrumentally by decision-makers in order to improve perceptions of reforms and help secure policy legacy. We theorize that this 'credibility premium' is more valuable for incumbents in politically polarized societies, which we empirically examine using two methods. First, we provide a series of vignettes of prominent randomized evaluations embedded by governments in policy roll-outs and a detailed case study of the Liberian government's decision to commission a third-party RCT evaluation of a proposed primary school privatization reform. Second, we have compiled a unique cross-country panel data set on RCTs in development policy since 1996, with which we demonstrate that RCTs are more likely to occur in polarized societies, and that the effect is amplified by the degree of political competition. [ABSTRACT FROM AUTHOR]

Older prisoners are the fasted growing sub group in prisons across developed countries. They have high levels of health and social care needs in relation to their younger counterpart and those of the same age living in the community. There are a lack of interventions to ensure their needs are met. The older prisoner health and social care assessment and plan (OHSCAP) provided a structured process for addressing need and it's effectiveness was evaluated in a randomised controlled trial (RCT). This paper presents findings from the nested qualitative study relating to this RCT. The aim of this study was to explore the facilitators and barriers to delivering the OHSCAP. Semi-structured interviews were conducted with twelve staff members delivering the OHSCAP and 14 service users who had received the intervention. The framework method was used to analyse the data produced. Participants described a 'broken' prison system. They discussed a staffing crisis resulting in individuals' human rights being violated, which led to dangerous conditions in the prison. These conditions further impeding the staffing crisis, as recruitment was difficult and staff sickness was high. This 'broken' prison cycle significantly contributed to a lack of adequate attention being paid to OHSCAP processes. The delivery of health and social care interventions in prison is challenging when basic systems relating to staffing and safety are not adequate. Future research needs to consider how these circumstances can be mitigated. [ABSTRACT FROM AUTHOR]

ehaviour change is a key to addressing many health and healthcare problems and interventions have been designed to improve health outcomes. These behaviour change interventions have been evaluated in many ways, including randomised controlled trials, and over recent decades there has been considerable progress in the conduct and reporting these studies. This paper is a personal retrospection on the changes occurring that have resulted in our current improved methods and their potential for future advancement. There has been steady development of methods for conducting trials, including advances in statistical methods enabled by increase computing power and programmes, greater attention to the recruitment of participants and in the specification of outcomes. Trial reporting has improved, largely due to publication of guidelines for reporting interventions and trials, but until recently the reporting of behaviour change interventions has been quite limited. Developments in the specification of active ingredients of these interventions, the behaviour change techniques, has transformed our ability to report interventions in a manner that facilitates evidence synthesis and enables replication and implementation. However, further work using ontological approaches is needed to adequately represent the evidence contained in the mass of accumulated studies. Meanwhile, attention is gradually being paid to the comparator groups in trials leading to better reporting but with continuing challenges about how control groups are selected. These developments are important for the advancements of behavioural science – but also in consolidating the expertise needed to address global social, environmental and health challenges. [ABSTRACT FROM AUTHOR]

Anti-malware software must be frequently updated in order to protect the system and the user from attack. Makers of this software must choose between interrupting the user to update immediately or allowing them to update later. In either case, assessing the content of the interruption may still require cognitive investment. However, by allowing the user to negotiate a delayed response to these interruptions, users can instead focus on their work. This paper experimentally examines the effect of immediate and negotiated interruptions on user decision time and decision accuracy in multiple stage tasks. For complex tasks, decision performance is higher when the user can negotiate the onset of and response to interruptions. The option to defer response also results in greater subjective perceptions of control, improved task resumption and reduced feelings of interruption and distraction on the part of the user, even within a short period of time. These findings have practical implications for endpoint security and where there is a need to mitigate the effects of user interruptions from computer-mediated communication in complex task situations. [ABSTRACT FROM AUTHOR]

Given the politicization of abortion, professionals working in U.S. health departments (HDs) may not be receptive to communications about abortion, despite often regulating abortion facilities. This paper reports results of a randomized, prospective, observational study to test the effects of e-mail language when disseminating evidence on abortion to HD professionals. Our sample was 302 HD employees who oversee healthcare facilities inspection/regulation in all 50 U.S. state HDs, clustered by HD and randomized into two study groups. In November–December 2019, we sent biweekly e-mails containing links to a website summarizing evidence on abortion facility regulation. E-mails/headers sent to one group emphasized public health values and did not include the word abortion; e-mails/headers to the other group used the word abortion. Primary outcome measures were e-mail open rates and click-through rates. Among 221 participants to whom e-mails were deliverable, the overall open rate was 36%. Open rate was 25% for PH values and 46% for abortion groups (p <.05). Effects were moderated by state abortion policy environment: in both supportive and restrictive environments, participants in the abortion messaging group were statistically more likely to open e-mails than those in the PH values group. There was no difference between groups in states with middle-ground abortion policy environments. Among participants opening at least one e-mail, 19% clicked through to the website, with no significant difference by group. This study demonstrates that repeated targeted e-mail campaigns can reach HD professionals with research summaries. Concerns that communications to HDs should avoid the word abortion are unsupported. [ABSTRACT FROM AUTHOR]

This paper presents findings from a randomized controlled trial studying a comprehensive program designed to support students in achieving their goals. One Million Degrees (OMD) is a nonprofit organization serving community college students in the Chicago metro area that supports students financially, academically, personally, and professionally. Results from our study demonstrate that the randomized offer of a spot in the OMD program leads to a statistically significant and substantively meaningful increase in community college enrollment, persistence, and associate's degree attainment three years after randomization. Applicants who applied while still in high school were less likely to take up the offer of the program than students who were already enrolled in community college, but those high school students who enrolled outperformed their control group peers by a substantially larger margin. Finally, we find the program does not appear to affect the likelihood that students will enroll in a four-year college. [ABSTRACT FROM AUTHOR]

Objective: To examine sex differences in the effectiveness of a Stories intervention for teaching affect recognition in people with a traumatic brain injury (TBI). Setting: Post-acute rehabilitation facilities. Participants: 203 participants (53 women and 150 men) with moderate to severe TBI were screened. 71 were eligible and randomized to one of three treatment conditions: two affect recognition conditions and an active control (cognition). This paper examines sex differences between the Stories intervention (n = 23, 5 women and 18 men) and the cognitive treatment control (n = 24, 8 women and 16 men). Design: Randomized controlled trial with immediate, 3- and 6-month follow-up post-tests. Interventions were 9 hours of computer-based training with a therapist. Measures: Facial Affect Recognition (DANVA2-AF); Emotional Inference from Stories Test (EIST). Results: A significant treatment effect was observed for the Stories intervention for women, who demonstrated and maintained improved facial affect recognition. In contrast, males in our sample did not benefit from the Stories intervention. Conclusion: This positive finding for the Stories intervention for females contrasts with our conclusions in a previous paper, where an analysis collapsed across sex did not reveal an overall effectiveness of the Stories intervention. This intervention warrants further research and development. [ABSTRACT FROM AUTHOR]

Chronic pain is a global problem, with a prevalence of 35–50%. This multifactorial condition is influenced by biological, psychological, and social factors. We assessed the efficacy of pain neuroscience education (PNE) on psychoemotional and cognitive variables in individuals with chronic musculoskeletal pain. We searched the PubMed, PEDro, Scopus, Web of Science, and CINHAL databases. We included randomised controlled trials conducted in adults with chronic musculoskeletal pain undergoing with PNE. The authors of these papers evaluated hypervigilance, attitudes and beliefs, knowledge of pain, and/or anxiety. We assessed risk of bias by using the ROB 2.0 tool. We performed a GRADE analysis to determine the quality of the evidence. We have reported the results using descriptive statistics and narrative synthesis. We included 10 articles that had implemented PNE. There were moderate to high effect sizes for the variables anxiety and knowledge of neurophysiology of pain and a moderate effect size for hypervigilance. Heterogeneity in the diagnosis of the participants, interventions, and follow-up periods did not allow us to perform a meta-analysis. The results suggest that there are benefits of PNE alone or in combination with another therapeutic modality. However, more research is required. [ABSTRACT FROM AUTHOR]

Social work clients often face complex financial problems. We have developed a financial social work intervention, FinSoc, to increase financial literacy and economic self-efficacy and reduce financial anxiety among parents with financial problems in Finland. The aim of this pilot randomized controlled trial is to explore the feasibility, acceptability, and preliminary effectiveness of the intervention. This paper, a study protocol, describes the design and implementation of the trial. Study protocols are articles detailing a priori the research plan, rationale, proposed methods and plans for how a clinical trial will be conducted. This study is a pilot randomized controlled trial with a mixed methods approach applying both quantitative measures and qualitative interviews. Participating social work clients with children are randomly assigned to either the treatment or the waiting list control group at a ratio of 1:1. The treatment group receives the intervention and the control group receives services as usual. The quantitative data from social work clients are collected at three measurement points. Qualitative interviews are conducted post-intervention with both clients receiving, and professionals implementing the intervention. The feasibility is assessed through recruitment and retention rates and the interviews with social work professionals providing the intervention. Acceptability is assessed through feedback from participants on satisfaction with the intervention and usefulness of the specific intervention components. Potential effectiveness is measured by financial literacy, economic self-efficacy and financial anxiety. The intervention is hypothesized to increase financial literacy and economic self-efficacy and reduce financial anxiety among social work clients with children. The results of this pilot study will increase the evidence base of financial social work and offer new insights for developing interventions for clients experiencing financial difficulties. [ABSTRACT FROM AUTHOR]