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Background Emollients are universally recommended for atopic dermatitis/eczema ('eczema'), to improve the skin barrier and reduce symptoms. However, our knowledge of the frequency and nature of adverse effects associated with their use is limited. Objectives We sought to determine how well adverse events are reported in randomized controlled trials (RCTs) of emollients for eczema. Methods MEDLINE was searched from inception (1946) to May 2022. Inclusion criteria were RCTs of moisturizers or emollients used as a leave-on treatment (as the intervention or control) in adults or children with eczema. Exclusion criteria were non-RCTs; patients with other diagnoses included; use of emollient as bath additives, soap substitutes or as preventative; and not published in English. References of eligible papers were reviewed for any additional, relevant research. Data were extracted into an Excel spreadsheet and analysed descriptively. An assessment of study quality was carried out using the Joanna Briggs Institute tool for RCTs. Results From 369 potential papers, 35 papers (reporting on 34 studies) were included. Most research was conducted in research centres or hospitals (unclear in 34%). In total, 89% reported collecting data on adverse events related to emollient treatment use but the methods used were poorly reported (40% unclear). Four papers used patient questionnaires/diaries. However, it was unclear how and what was collected as only two studies showed the questionnaires used. Conclusions Reporting of adverse events related to emollient use in trials of patients with eczema is poor and inconsistent. Agreement should be reached on how and what adverse events should be collected, to standardize reporting across studies. [ABSTRACT FROM AUTHOR]

The article focuses on a study related to sports injuries. About 154 oral abstracts presented at the World Congress of Sports Injury Prevention 2005 Oslo and the corresponding full paper publication were identified and analyzed. A considerable proportion of health care research are first presented at conferences and meetings, and published as abstracts in the proceedings.

In this commentary, we complement other constructive critiques of educational randomized control trials (RCTs) by calling attention to the commonly ignored role of context in causal mechanisms undergirding educational phenomena. We argue that evidence for the central role of context in causal mechanisms challenges the assumption that RCT findings can be uncritically generalized across settings. Anchoring our argument with an example from our own multistudy RCT project, we argue that the scientific pursuit of causal explanation should involve the rich description of contextualized causal effects. We further call for incorporating the "evidence" of the integral role of context in causal mechanisms into the meaning of "evidence-based practice," with the implication that effective implementation of practice in a new setting must involve context-oriented, evidence-focused, design-based research that attends to the emergent, complex, and dynamic nature of educational contexts. [For the Grantee Submission, see ED605239.]

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]

Background: Heart failure (HF) is the most common cardiovascular reason for hospital admission, particularly among patients older than 60 years old. Heart failure with reduced ejection fraction (HFrEF) comprises approximately 50% of all heart failure cases. Home-based cardiac rehabilitation (HBCR) is an alternative option to enhance the participation rate in cardiac rehabilitation (CR) interventions for patients who are not able to attend center-based cardiac rehabilitation (CBCR). The purpose of this review is to clarify the extent to which present studies of HBCR align with the core components defined by both the European Society of Cardiology (ESC) and the British Association for Cardiac Prevention and Rehabilitation (BACPR). Methods: A critical review was conducted through four databases, MEDLINE, Embase, Cochrane Central Register of Controlled Trials, and Cochrane Database of Systematic Reviews, to identify randomized controlled trials up until June 2022. We scrutinized the commonalities between BACPR and ESC and developed a list of standards. The risk of bias was assessed using the RoB 2 tool. Results: Among the 87 papers selected for full-text screening, 11 studies met the inclusion criteria. Six papers possessed a high proportion of fidelity to essential standards, four studies had a medium alliance, and one intervention had a low level of alliance. Conclusion: Overall, the majority of included studies had medium to high alignment with standards and core components. However, a need for more attention to long-term strategy as an important standard is revealed. Rapid identification and initial assessment are the most met standards; however, lifestyle risk factor management and long-term outcomes were recognized as the least met standards. [ABSTRACT FROM AUTHOR]

There are concerns that too many young people, from disadvantaged backgrounds, are moving into secondary education in the UK, and elsewhere, without the necessary literacy skills to make progress with the wider secondary school curriculum. A large number of interventions have been proposed to reduce this poverty gradient. This paper summarises the evidence from randomised controlled trials of seven popular interventions, giving a different comparative perspective to individual reports, and permitting more detail than a wider review. Of these, it shows that Switch-on Reading (Reading Recovery) and Accelerated Reader, for example, are currently the most promising. And that summer schools and the use of generic literacy software are the least successful and may even harm pupil progress. The way in which the evidence is assessed in this paper suggests a way forward for practitioners and policy-makers navigating the evidence in their areas of interest. There is also evidence that practitioners should be able to conduct robust evaluations of their own with only minimal support, which could lead to a revolution in school improvement. The combined results suggest that "soft" evaluations may be worse than just a waste of time and money, and that theoretical explanations might appear satisfying to readers but are largely unnecessary when assessing "what works" in education.

The article presents various studies along with their aim, methods, and conclusion. Topics include prognostic value of preoperative Alpha-fetoprotein (AFP) level in patients receiving curative hepatectomy, using randomized controlled trial for examining the impact of enhanced geraitric input on elderly patients undergoing colorectal cancer surgery, and evaluating the optimal ablation duration of adrenal radiofrequency ablation using porcine model.

Introduction: Although the effect of educational methods on executive function (EF) is well known, training this function by a playful method is debatable. The current study aimed at investigating if a play-based intervention is effective on metacognitive and behavioral skills of EF in students with specific learning disabilities. Methods: In the current randomized, clinical trial, 49 subjects within the age range of 7 to 11 years with specific learning disabilities were randomly assigned into the intervention (25 subjects; mean age 8.5±1.33 years) and control (24 subjects; mean age 8.7±1.03 years) groups. Subjects in the intervention group received EF group training based on playing activities; subjects in the control group received no intervention. The behavior rating inventory of executive function (BRIEF) was administered to evaluate the behavioral and cognitive aspects of EF. The duration of the intervention was 6 hours per week for 9 weeks. Multivariate analysis of covariance was used to compare mean changes (before and after) in the BRIEF scores between the groups. Results: The assumptions of multivariate analysis of covariance were examined. After controlling pre-test conditions, the intervention and control groups scored significantly differently on both the metacognition (P=0.002; effect size=0.20) and behavior regulation indices (P=0.01; effect size=0.12) of BRIEF. Conclusion: Play-based therapy is effective on the metacognitive and behavioral aspects of EF in students with specific learning disabilities. Professionals can use play-based therapy rather than educational approaches in clinical practice to enhance EF skills. [ABSTRACT FROM AUTHOR]

Background and objectives: Treatment of spasticity poses a major challenge given the complex clinical presentation and variable efficacy and safety profiles of available drugs. We present a systematic review of the pharmacological treatment of spasticity in multiple sclerosis (MS) patients. Methods: Controlled trials and observational studies were identified. Scientific evidence was evaluated according to pre-specified levels of certainty. Results: The evidence supports the use of baclofen, tizanidine and gabapentin as first-line options. Diazepam or dantrolene could be considered if no clinical improvement is seen with the previous drugs. Nabiximols has a positive effect when used as add-on therapy in patients with poor response and/or tolerance to first-line oral treatments. Despite limited evidence, intrathecal baclofen and intrathecal phenol show a positive effect in severe spasticity and suboptimal response to oral drugs. Conclusion: The available studies on spasticity treatment offer some insight to guide clinical practice but are of variable methodological quality. Large, well-designed trials are needed to confirm the effectiveness of antispasticity agents and to produce evidence-based treatment algorithms. [ABSTRACT FROM AUTHOR]

The article offers information on reduction of disease activity in axial spondyloarthritis from High intensity exercise for three months, as compared with standard care.

Aims and objectives. The aims of this study were to measure skin moisture and transepidermal water loss after application of uncoated paper and to compare skin moisture and transepidermal water loss after use of uncoated paper and disposable underpads. Study design. The study was a cross-over, prospective, open-labeled, randomized trial. Sample and setting. Bedridden patients aged ≥18 years at a medical center in Korea were included. Treatment order was randomly assigned using block randomization, with a block size of 4 and an assignment rate of one-by-one. Methods. Skin moisture was measured using a Corneometer 825 and transepidermal water loss was measured using a Tewameter 300. Results. Skin moisture after application of an uncoated paper was significantly lower than observed after application of a disposable underpad (mean 40·6 and SD 13·1 vs. mean 64·6 and SD 23·7, p < 0·001). Transepidermal water loss also showed greater health scores after using uncoated paper (mean 11·1 and SD 5·7 g/m2/hour) than after applying a disposable underpad (mean 23·2 and SD 11·1 g/m2/hour, p < 0·001). There were no statistical between-group differences in room temperature, relative humidity, and body temperature. Conclusion. We found that uncoated paper was helpful in avoiding excessive moisture without adverse effects. Relevance to clinical practice. As indicated by the results of this study, uncoated paper can be applied to bed-ridden patients who required incontinence care. Nurses may consider using uncoated paper as one of nursing methods in the routine care of bed-ridden patients for moisture control. [ABSTRACT FROM AUTHOR]

Background: Electronic recording of vital sign observations (e-Obs) has become increasingly prevalent in hospital care. The evidence of clinical impact for these systems is mixed. Objective: The objective of our study was to assess the effect of e-Obs versus paper documentation (paper) on length of stay (time between trauma unit admission and "fit to discharge") for trauma patients. Methods: A single-center, randomized stepped-wedge study of e-Obs against paper was conducted in two 26-bed trauma wards at a medium-sized UK teaching hospital. Randomization of the phased intervention order to 12 study areas was computer generated. The primary outcome was length of stay. Results: A total of 1232 patient episodes were randomized (paper: 628, e-Obs: 604). There were 37 deaths in hospital: 21 in the paper arm and 16 in the e-Obs arm. For discharged patients, the median length of stay was 5.4 (range: 0.2-79.0) days on the paper arm and 5.6 (range: 0.1-236.7) days on the e-Obs arm. Competing risks regression analysis for time to discharge showed no difference between the treatment arms (subhazard ratio: 1.05; 95% CI 0.82-1.35; P=.68). A greater proportion of patient episodes contained an Early Warning Score (EWS) ≥3 using the e-Obs system than using paper (subhazard ratio: 1.63; 95% CI 1.28-2.09; P<.001). However, there was no difference in the time to the subsequent observation, "escalation time" (hazard ratio 1.05; 95% CI 0.80-1.38; P=.70). Conclusions: The phased introduction of an e-Obs documentation system was not associated with a change in length of stay. A greater proportion of patient episodes contained an EWS≥3 using the e-Obs system, but this was not associated with a change in "escalation time." Trial Registration: ISRCTN Registry ISRCTN91040762; http://www.isrctn.com/ISRCTN91040762 (Archived by WebCite at http://www.webcitation.org/72prakGTU) [ABSTRACT FROM AUTHOR]

Background: Randomised controlled trials (RCTs) have long been considered the gold standard in education research. Federal funds are allocated to evaluations that meet What Works Clearinghouse standards; RCT designs are required in order to meet these standards without reservations. Schools seek out interventions that are research based, in other words, interventions that have demonstrated effects in RCTs, creating a cycle that incentivises RCT research. However, RCTs pose tremendous obstacles for school-based participants. Methods: This paper presents a descriptive case study of an RCT of an adolescent reading intervention implemented in four districts over three years, drawing on interviews and document analysis to illustrate the challenges that participation in an RCT poses for schools. Results: In two participating districts, the random assignment requirement caused major difficulties with recruitment and retention. Of the 15 schools that began implementation in fall of year 1, 11 left the study by fall of year 2. Of those 11, eight explicitly stated that the random assignment requirement was the reason they withdrew. Stakeholders expressed that they felt it was unethical to withhold the intervention from some students. Conclusions: This rate of attrition casts doubt on the external validity of the programme evaluation, as these schools are likely to systematically differ from schools that met the requirements of random assignment. Suggestions are offered for alternative methods that may be used to evaluate promising interventions, in ways that are better aligned with real-world educational contexts.

Objectives: To evaluate the robustness of the intervention modeling experiment (IME) methodology as a way of developing and testing behavioral change interventions before a full-scale trial by replicating an earlier paper-based IME. Study Design and Setting: Web-based questionnaire and clinical scenario study. General practitioners across Scotland were invited to complete the questionnaire and scenarios, which were then used to identify predictors of antibiotic-prescribing behavior. These predictors were compared with the predictors identified in an earlier paper-based IME and used to develop a new intervention. Results: Two hundred seventy general practitioners completed the questionnaires and scenarios. The constructs that predicted simulated behavior and intention were attitude, perceived behavioral control, risk perception/anticipated consequences, and self-efficacy, which match the targets identified in the earlier paper-based IME. The choice of persuasive communication as an intervention in the earlier IME was also confirmed. Additionally, a new intervention, an action plan, was developed. Conclusion: A web-based IME replicated the findings of an earlier paper-based IME, which provides confidence in the IME methodology. The interventions will now be evaluated in the next stage of the IME, a web-based randomized controlled trial. [ABSTRACT FROM AUTHOR]

This paper examines the insistent claims by advocates of evidence-based teaching that it is a rigorous scientific approach. The paper questions the view that randomised controlled trials and meta-analyses are the only truly scientific methods in educational research. It suggests these claims are often based on a rhetorical appeal which relies on too simple a notion of "science". Exploring the tacit assumptions behind "evidence-based teaching", the paper identifies an empiricist and reductionist philosophy of science, and a failure to recognise the complexity of education and pedagogy. Following a discussion of large-scale syntheses of evidence (Hattie's Visible Learning; the Education Endowment Foundation's Teaching and Learning Toolkit), it examines in detail one strand of the latter concerning sports participation, which is used to illustrate flaws in procedures and the failure to take seriously the need for causal explanations.

Background: Handheld computers are increasingly favoured over paper and pencil methods to capture data in clinical research. Methods: This study systematically identified and reviewed randomized controlled trials (RCTs) that compared the two methods for self-recording and reporting data, and where at least one of the following outcomes was assessed: data accuracy; timeliness of data capture; and adherence to protocols for data collection. Results: A comprehensive key word search of NLM Gateway's database yielded 9 studies fitting the criteria for inclusion. Data extraction was performed and checked by two of the authors. None of the studies included all outcomes. The results overall, favor handheld computers over paper and pencil for data collection among study participants but the data are not uniform for the different outcomes. Handheld computers appear superior in timeliness of receipt and data handling (four of four studies) and are preferred by most subjects (three of four studies). On the other hand, only one of the trials adequately compared adherence to instructions for recording and submission of data (handheld computers were superior), and comparisons of accuracy were inconsistent between five studies. Conclusion: Handhelds are an effective alternative to paper and pencil modes of data collection; they are faster and were preferred by most users. [ABSTRACT FROM AUTHOR]

Background: Sponsors that seek to commercialize new drugs apply to the Food and Drug Administration (FDA) which independently analyzes the raw data and reports the results on its website. Objectives: This study sought to determine if there are differences between the FDA assessments and journal reports on biologic agents developed for the treatment of rheumatoid arthritis. Methods: Available data on FDA-approved drugs were extracted from the website, and a systematic literature search was conducted to identify matching studies in peer-reviewed medical journals. Outcome measures were the American College of Rheumatology response criteria ACR20 (efficacy) and withdrawal due to adverse events (safety). As effect size odds ratios were estimated for each active trial arm vs. control arm (i.e. for both sources: FDA and journal report), followed by calculation of the ratios of the FDA and journal report odds ratios. A ratio of odds ratios not equal to 1 was categorized as a discrepancy. Results: FDA reports were available for 8 of 9 FDA-approved biologic agents for rheumatoid arthritis; all identified trials (34) except one were published in peer-reviewed journals. Overall, discrepancies were noted for 20 of the 33 evaluated trials. Differences in the apparent benefit reporting were found in 39% (24/61) pairwise comparisons and in 11 cases these were statistically significant; the FDA report showed greater benefit than the journal publication in 15 comparisons and lesser benefit in 9. Differences in the reported harms were found in 51% (28/55) pairwise comparisons and were statistically significant in 5. The “signal” in FDA reports showed a less harmful effect than the journal publication in 17 comparisons whereas a more harmful effect in 11. The differences were attributed to differences in analytic approach, patient inclusion, rounding effect, and counting discrepancies. However, no differences were categorized as critical. Conclusion: There was no empirical evidence to suggest biased estimates between the two sources. Increased and detailed transparency in publications would improve the understanding and credibility of published results. Further, the FDA report was found to be a useful source when data are missing in the published report (i.e. reporting bias). [ABSTRACT FROM AUTHOR]

Background Allergen immunotherapy ( AIT) has been thoroughly documented in randomized controlled trials ( RCTs). It is the only immune-modifying and causal treatment available for patients suffering from Ig E-mediated diseases such as allergic rhinoconjunctivitis, allergic asthma and insect sting allergy. However, there is a high degree of clinical and methodological heterogeneity among the endpoints in clinical studies on AIT, for both subcutaneous and sublingual immunotherapy ( SCIT and SLIT). At present, there are no commonly accepted standards for defining the optimal outcome parameters to be used for both primary and secondary endpoints. Methods As elaborated by a Task Force ( TF) of the European Academy of Allergy and Clinical Immunology ( EAACI) Immunotherapy Interest Group, this Position Paper evaluates the currently used outcome parameters in different RCTs and also aims to provide recommendations for the optimal endpoints in future AIT trials for allergic rhinoconjunctivitis. Results Based on a thorough literature review, the TF members have outlined recommendations for nine domains of clinical outcome measures. As the primary outcome, the TF recommends a homogeneous combined symptom and medication score ( CSMS) as a simple and standardized method that balances both symptoms and the need for antiallergic medication in an equally weighted manner. All outcomes, grouped into nine domains, are reviewed. Conclusion A standardized and globally harmonized method for analysing the clinical efficacy of AIT products in RCTs is required. The EAACI TF highlights the CSMS as the primary endpoint for future RCTs in AIT for allergic rhinoconjunctivitis. [ABSTRACT FROM AUTHOR]

Research has tremendously contributed to the developments in both practical and fundamental aspects of limb prosthetics. These advancements are reflected in scientific articles, particularly in the most cited papers. This article aimed to identify the 100 top-cited articles in the field of limb prosthetics and to investigate their main characteristics. Articles related to the field of limb prosthetics and published in the Web of Knowledge database of the Institute for Scientific Information (ISI) from the period of 1980 to 2012. The 100 most cited articles in limb prosthetics were selected based on the citation index report. All types of articles except for proceedings and letters were included in the study. The study design and level of evidence were determined using Sackett's initial rules of evidence. The level of evidence was categorized either as a systematic review or meta-analysis, randomized controlled trial, cohort study, case-control study, case series, expert opinion, or design and development. The top cited articles in prosthetics were published from 1980 to 2012 with a citation range of 11 to 90 times since publication. The mean citation rate was 24.43 (SD 16.7) times. Eighty-four percent of the articles were original publications and were most commonly prospective (76%) and case series studies (67%) that used human subjects (96%) providing level 4 evidence. Among the various fields, rehabilitation (47%), orthopedics (29%), and sport sciences (28%) were the most common fields of study. The study established that studies conducted in North America and were written in English had the highest citations. Top cited articles primarily dealt with lower limb prosthetics, specifically, on transtibial and transradial prosthetic limbs. Majority of the articles were experimental studies. [ABSTRACT FROM AUTHOR]

Background: Health and social care interventions are often complex and can be decomposed into multiple components. Multicomponent interventions are often evaluated in randomised controlled trials. Across trials, interventions often have components in common which are given alongside other components which differ across trials. Multicomponent interventions can be synthesised using component NMA (CNMA). CNMA is limited by the structure of the available evidence, but it is not always straightforward to visualise such complex evidence networks. The aim of this paper is to develop tools to visualise the structure of complex evidence networks to support CNMA. Methods: We performed a citation review of two key CNMA methods papers to identify existing published CNMA analyses and reviewed how they graphically represent intervention complexity and comparisons across trials. Building on identified shortcomings of existing visualisation approaches, we propose three approaches to standardise visualising the data structure and/or availability of data: CNMA-UpSet plot, CNMA heat map, CNMA-circle plot. We use a motivating example to illustrate these plots. Results: We identified 34 articles reporting CNMAs. A network diagram was the most common plot type used to visualise the data structure for CNMA (26/34 papers), but was unable to express the complex data structures and large number of components and potential combinations of components associated with CNMA. Therefore, we focused visualisation development around representing the data structure of a CNMA more completely. The CNMA-UpSet plot presents arm-level data and is suitable for networks with large numbers of components or combinations of components. Heat maps can be utilised to inform decisions about which pairwise interactions to consider for inclusion in a CNMA model. The CNMA-circle plot visualises the combinations of components which differ between trial arms and offers flexibility in presenting additional information such as the number of patients experiencing the outcome of interest in each arm. Conclusions: As CNMA becomes more widely used for the evaluation of multicomponent interventions, the novel CNMA-specific visualisations presented in this paper, which improve on the limitations of existing visualisations, will be important to aid understanding of the complex data structure and facilitate interpretation of the CNMA results. [ABSTRACT FROM AUTHOR]