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• The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia. • Improvements on severity of symptoms in both groups suggest that the self-care program using a mobile app or a paper book may be beneficial in individuals with fibromyalgia. • The Sleep Strategies was the most used function of the ProFibro app, followed by the Exercise Program, and the diary for the practice of gratitude. The ProFibro application (app) was developed as a Mobile Health resource to promote self-care in fibromyalgia management. This study aimed to assess the effects of the use of the ProFibro app for six weeks compared to the use of a traditional paper book of similar content to improve health-related quality of life, symptoms, and self-care agency in individuals with fibromyalgia. Forty individuals with fibromyalgia were included in this randomized, single-blind, parallel trial. One group received intervention content using the ProFibro app on a smartphone while the other received similar information using a paper book. Participants were assessed at baseline and after six weeks. The primary outcome was the Revised Fibromyalgia Impact Questionnaire. Secondary outcomes were Widespread Pain Index, Pain Visual Analog Scale, Symptom Severity Scale, and Appraisal of Self-Care Agency Scale – Revised. No differences in changes were found between groups at the end of the treatment for any outcome. Both groups showed improvements in symptom severity. The use of the ProFibro app for six weeks was not more effective than the use of a traditional paper book with similar content for health-related quality of life, symptoms, or self-care agency in individuals with fibromyalgia. Both groups showed improvements from baseline on severity of symptoms, suggesting that the self-care program using a mobile app or a paper book may be beneficial for individuals with fibromyalgia. [ABSTRACT FROM AUTHOR]

Question Do people with musculoskeletal conditions better adhere to their home exercise programs when these are provided to them on an app with remote support compared to paper handouts? Design Randomised, parallel-group trial with intention-to-treat analysis. Participants Eighty participants with upper or lower limb musculoskeletal conditions were recruited to the trial. Each participant was prescribed a 4-week home exercise program by a physiotherapist at a tertiary teaching hospital in Australia. Participants were randomly assigned via a computer-generated concealed block randomisation procedure to either intervention (n = 40) or control (n = 40) groups. Intervention Participants in the intervention group received their home exercise programs on an app linked to the freely available website www.physiotherapyexercises.com . They also received supplementary phone calls and motivational text messages. Participants in the control group received their home exercise programs as a paper handout. Outcome measures Blinded assessors collected outcome measures at baseline and 4 weeks. The primary outcome was self-reported exercise adherence. There were five secondary outcomes, which captured functional performance, disability, patient satisfaction, perceptions of treatment effectiveness, and different aspects of adherence. Results Outcomes were available on 77 participants. The mean between-group difference for self-reported exercise adherence at 4 weeks was 1.3/11 points (95% CI 0.2 to 2.3), favouring the intervention group. The mean between-group difference for function was 0.9/11 points (95% CI 0.1 to 1.7) on the Patient-Specific Functional Scale, also favouring the intervention group. There were no significant between-group differences for the remaining outcomes. Conclusion People with musculoskeletal conditions adhere better to their home exercise programs when the programs are provided on an app with remote support compared to paper handouts; however, the clinical importance of this added adherence is unclear. Trial registration ACTRN12616000066482. [Lambert TE, Harvey LA, Avdalis C, Chen LW, Jeyalingam S, Pratt CA, Tatum HJ, Bowden JL, Lucas BR (2017) An app with remote support achieves better adherence to home exercise programs than paper handouts in people with musculoskeletal conditions: a randomised trial. Journal of Physiotherapy 63: 161–167] [ABSTRACT FROM AUTHOR]

Abstract: The ability to critically analyse surgical papers is an important skill that all surgeons should possess. This article describes a simple two-step approach to the appraisal of scientific literature. It relies on a rapid review based on the abstract followed by a detailed review based on simple checklists. These can be applied to systematic reviews, randomized trials and observational studies. At the end of the process, the quality of the methods, quality of the results and applicability of the work are evaluated to formulate an opinion on overall quality. The article ends with a suggested format for writing a report based on such an appraisal. [Copyright &y& Elsevier]

In 2015, the first large‐scale placebo‐controlled trial designed to assess cardiovascular safety of glucose‐lowering with sodium–glucose co‐transporter 2 (SGLT2) inhibition in type 2 diabetes mellitus raised hypotheses that the class could favourably modify not only risk of atherosclerotic cardiovascular disease, but also hospitalization for heart failure, and the development or worsening of nephropathy. By the start of 2021, results from 10 large SGLT2 inhibitor placebo‐controlled clinical outcome trials randomizing ∼71 000 individuals have confirmed that SGLT2 inhibitors can provide clinical benefits for each of these types of outcome in a range of different populations. The cardiovascular and renal benefits of SGLT2 inhibitors appear to be larger than their comparatively modest effect on glycaemic control or glycosuria alone would predict, with three trials recently reporting that clinical benefits extend to individuals without diabetes mellitus who are at risk due to established heart failure, or albuminuric chronic kidney disease. This European Society of Cardiology position paper summarizes reported results from these 10 large clinical outcome trials considering separately each of the different types of cardiorenal benefit, summarizes key molecular and pathophysiological mechanisms, and provides a synopsis of metabolic effects and safety. We also describe ongoing placebo‐controlled trials among individuals with heart failure with preserved ejection fraction and among individuals with chronic kidney disease. [ABSTRACT FROM AUTHOR]

Background: This paper presents the baseline characteristics and their moderators in the Healthy Learning Mind (HLM)-- school-based cluster-randomized controlled trial. Objectives: The paper evaluates the state of various measures of well-being, their moderators and how these results compare to national and global norms/population studies. Methods: Data were collected from all participants prior to the intervention and further analyzed by gender, grade and perceived socioeconomic status, including standardized measures for resilience, depressive symptoms and socioemotional functioning; health-related quality of life, dispositional mindfulness, satisfaction with life, compassion/self-kindness, self-rated health and morning tiredness. Results: Participating 2793 students (1425 girls, 1368 boys), ages 12 to 15 years, filled in the questionnaires. The outcomes were in line with previous research, demonstrating gender differentiation and lower wellbeing among older children and adolescents. Conclusions: All outcomes were associated with perceived socioeconomic status, suggesting that perceived low socioeconomic status should be addressed as a serious risk factor and included as a moderator in similar trials.

Reading is critical to success in college. Faculty members often decry students who come to class without reading, and unprepared for the lessons of the day. Yet, relatively little empirical research assesses how to best stimulate collegiate reading and what types of reading assessments provide the best student learning outcomes. This paper assesses two common ways of assessing reading compliance and learning--reading quizzes and Course Preparation Assignments (CPAs)--using a randomized trial in a large introductory political science course. The data show that students are more compliant with completing the reading quizzes vs. the CPAs, and that students prefer completing the reading quizzes to the CPAs. Data from the 2020 Assessing Critical Reading Techniques study demonstrate little substantive difference between the two groups on the measured learning outcomes through either the exams or the papers. These findings provide empirical support that traditional methods of reading checks or assessments can provide value to the student learning process. Implications for instructors across different course formats are discussed.

This paper introduces a simple, quotient effect size, termed (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 as an effect size for reporting on the effectiveness of educational interventions, as compared with Cohen's d, and addresses some possible objections.

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.

McKinney (2018) has argued that for the scholarship of teaching and learning (SoTL) to advance within a discipline, the integration of SoTL must be closely examined and opportunities for growth in SoTL must be recognized and discussed. To that end, this paper reflects on the degree to which SoTL is integrated into communication sciences and disorders (CSD) by examining a variety of topics: perspectives and theories historically valued by our discipline, existing supports for SoTL at various levels (i.e., individual teacher-scholars, departments, institutions, and the CSD discipline as a whole), the application of SoTL findings in teaching and learning. Four specific recommendations are made because of this examination and reflection.

Randomized A/B tests within online learning platforms represent an exciting direction in learning sciences. With minimal assumptions, they allow causal effect estimation without confounding bias and exact statistical inference even in small samples. However, often experimental samples and/or treatment effects are small, A/B tests are underpowered, and effect estimates are overly imprecise. Recent methodological advances have shown that power and statistical precision can be substantially boosted by coupling design-based causal estimation to machine-learning models of rich log data from historical users who were not in the experiment. Estimates using these techniques remain unbiased and inference remains exact without any additional assumptions. This paper reviews those methods and applies them to a new dataset including over 250 randomized A/B comparisons conducted within ASSISTments, an online learning platform. We compare results across experiments using four novel deep-learning models of auxiliary data and show that incorporating auxiliary data into causal estimates is roughly equivalent to increasing the sample size by 20% on average, or as much as 50-80% in some cases, relative to t-tests, and by about 10% on average, or as much as 30-50%, compared to cutting-edge machine learning unbiased estimates that use only data from the experiments. We show that the gains can be even larger for estimating subgroup effects, hold even when the remnant is unrepresentative of the A/B test sample, and extend to post-stratification population effects estimators.

To investigate if a written guide or augmented reality (AR) guide improves free recall of diversified chiropractic adjusting technique and to capture participants' impressions of the study in a poststudy questionnaire. Thirty-eight chiropractic students were evaluated for diversified listing (a nomenclature denoting vertebral malposition and correction) recall, pre-AR and post-AR, or written guide review. The vertebral segments used were C7 and T6. Two randomized groups reviewed an original course written guide (n = 18) or a new AR guide (n = 20). A Wilcoxon-Mann-Whitney (C7) and t test (T6) compared group differences in reevaluation scores. A poststudy questionnaire was given to capture participants' impressions of the study. Both groups showed no significant differences in free recall scores after reviewing the guides for C7 or T6. The poststudy questionnaire suggested a number of strategies could be used to improve current teaching material such as more detail in the written guides and organizing content into smaller blocks. Use of an AR or written guide does not seem to change participants' free recall ability when used to review diversified technique listings. The poststudy questionnaire was useful to identify strategies to improve currently used teaching material. [ABSTRACT FROM AUTHOR]

Background and objective: The number of people suffering from dementia is increasing worldwide and so is the need for reliable and economical diagnostic instruments. Therefore, the aim of this study was to compare the processing times of the neuropsychological tests Trail Making Tests A and B (TMT-A/B) and Color-Word Interference Test (CWIT), which were performed in both digital and paper versions. Methods: The pilot study was conducted among 50 healthy participants (age 65–83 years) using a randomized crossover design. The correlations and differences in the individual processing times of the two test versions were statistically analyzed. Further research questions concerned the influence of the individual usage of technology and the technology commitment of participants as well as the influence of the assessed usability on participants' performance. Results: Between the two versions (paper-based vs. digital) statistically significant correlations were found in all tests, e.g., TMT-A r(48) = 0.63, p < 0.01; TMT-B rs(48) = 0.77, p < 0.001). The mean value comparison showed statistically significant differences, e.g., interference table (CWIT) t(49) = 11.24, p < 0.01). Correlations with medium effect were found between the differences in processing times and the individual usage of computer (e.g., rs(48) = − 0.31) and smartphone (rs(48) = − 0.29) and between the processing times of the TMT-B and the usability (rs(48) = 0.29). Conclusions: The high correlations between the test procedures appear promising. However, the differences found in the processing times of the two test versions require validation and standardization of digitized test procedures before they can be used in practice. [ABSTRACT FROM AUTHOR]

Objective Friction foot blisters are a common injury occurring in up to 39% of marathoners, the most common injury in adventure racing, and represent more than 70% of medical visits in multi-stage ultramarathons. The goal of the study was to determine whether paper tape could prevent foot blisters in ultramarathon runners. Methods This prospective randomized trial was undertaken during RacingThePlanet 155-mile (250-km), 7-day self-supported ultramarathons in China, Australia, Egypt, Chile, and Nepal in 2010 and 2011. Paper tape was applied prerace to one randomly selected foot, with the untreated foot acting as the own control. The study end point was development of a hot spot or blister on any location of either foot. Results One hundred thirty-six participants were enrolled with 90 (66%) having completed data for analysis. There were 36% women, with a mean age of 40 ± 9.4 years (range, 25–40 years) and pack weight of 11 ± 1.8 kg (range, 8–16 kg). All participants developed blisters, with 89% occurring by day 2 and 59% located on the toes. No protective effect was observed by the intervention (47 versus 35; 52% versus 39%; P = .22), with fewer blisters occurring around the tape on the experimental foot than under the tape (23 vs 31; 25.6% versus 34.4%), yet 84% of study participants when queried would choose paper tape for blister prevention in the future. Conclusions Although paper tape was not found to be significantly protective against blisters, the intervention was well tolerated with high user satisfaction. [ABSTRACT FROM AUTHOR]

Background: With advances in cancer diagnosis and treatment, women with early-stage breast cancer (ESBC) are living longer, increasing the number of patients receiving post-treatment follow-up care. Best-practice survivorship models recommend transitioning ESBC patients from oncology-provider (OP) care to community-based care. While developing materials for a future randomized controlled trial (RCT) to test the feasibility of a nurse-led Telephone Survivorship Clinic (TSC) for a smooth transition of ESBC survivors to follow-up care, we explored patients' and OPs' reactions to several of our proposed methods.Methods: We used a qualitative study design with thematic analysis and a two-pronged approach. We interviewed OPs, seeking feedback on ways to recruit their ESBC patients for the trial, and ESBC patients, seeking input on a questionnaire package assessing outcomes and processes in the trial.Results: OPs identified facilitators and barriers and offered suggestions for study design and recruitment process improvement. Facilitators included the novelty and utility of the study and simplicity of methods; barriers included lack of coordination between treating and discharging clinicians, time constraints, language barriers, motivation, and using a paper-based referral letter. OPs suggested using a combination of electronic and paper referral letters and supporting clinicians to help with recruitment. Patient advisors reported satisfaction with the content and length of the assessment package. However, they questioned the relevance of some questions (childhood trauma) while adding questions about trust in physicians and proximity to primary-care providers.Conclusions: OPs and patient advisors rated our methods for the proposed trial highly for their simplicity and relevance then suggested changes. These findings document processes that could be effective for cancer-patient recruitment in survivorship clinical trials. [ABSTRACT FROM AUTHOR]

Pain represents a common symptom of several diseases and is often associated with a reduction in rehabilitation outcomes and recovery. The effectiveness of pain alleviation by botulinum toxin has been recently demonstrated. We searched in PubMed the papers about this topic published in the last ten years, and we selected clinical trials, guidelines, meta-analyses, reviews, and systematic reviews. We used different approaches: multiperspective presentation, lexical evaluation, and systematic review. The systematic review was only performed for the randomized controlled trials. We predominantly found reviews and trials about the rehabilitation of stroke/brain injury and epicondylitis. The most common outcome measures were pain, function, and spasticity. Among the common words, pain was the most frequent and the terms were grouped into different families, especially concerning the outcomes. Rehabilitation showed a relatively low frequency. Finally, the systematic review showed moderate-low levels of bias which confirms the effectiveness of botulinum toxin for pain treatment. The current literature about botulinum toxin is wide and globally diffuse but with some limitations in study strategies and clearness in the formal presentation. The evidence justifies the use of botulinum toxin in treating pain in different diseases. [ABSTRACT FROM AUTHOR]

Introduction: Reports of consensus conferences are usually valued less than reports of clinical trials even when rigorous methodology is used. However, limited data are available comparing the impact of these 2 methods of shaping clinical practice. Objective: Compare the publication impact of consensus conferences and clinical trials. Methods: Consensus publications from the Acute Disease Quality Initiative (ADQI) from 2002 through 2017 were identified and classified by subject matter. Randomized trials were identified in the same publication year and subject in journals, starting with the highest impact factor. Both publication types were matched, and total citations were determined for each using Google Scholar. A secondary analysis compared total costs for each publication type. Results and Conclusions: Seventeen ADQI consensus conference reports and 17 randomized trials were identified. ADQI reports received a similar number of citations per paper (median, interquartile range) compared to randomized trials (132, 54–228; vs. 159, 60–340, p = ns). Similarly, 10 (58.8%) ADQI reports and 10 randomized trials were cited >100 times. On average, ADQI reports appeared in journals with lower impact factors compared to clinical trials (5.4 ± 4.6 vs. 25.4 ± 27.1; p < 0.01). The median cost per citation (USD 2017) for ADQI reports was USD 606.01 compared to almost twice this figure, USD 1,182.59, for clinical trials on the same topics (p = 0.09). Despite being published in lower impact factor journals, consensus reports on topics in critical care nephrology, received similar citations to randomized controlled trials published the same year. [ABSTRACT FROM AUTHOR]

Although many patients suffer from taste disorder, methods to improve taste sensitivity are limited. To develop a taste recall training method to improve the perception of taste, 42 healthy individuals were randomly assigned to either the training or the control group. Using the filter paper disc method, participants in the training group were asked to match the four tastes (sweetness, saltiness, sourness, and bitterness) between those of taste recognition thresholds and those of a one-step higher concentration until they get them right. Then, they were asked to match the four tastes between those of one-step lower and one-step higher in concentration from their taste recognition thresholds until they get them right. Finally, they were asked to match the four tastes between those of one-step lower concentration and those of their taste recognition thresholds until they get them right. This training was repeated until perfectly matched. The taste recall training program led to a lowered taste recognition threshold in healthy adults for each taste quality, suggesting the improvement of taste sensitivity. This lowered threshold for each taste was observed with each additional training session. We conclude that this taste recall training method might be a therapeutic approach for treating taste disorder. [ABSTRACT FROM AUTHOR]

Background: Overall survival is the "gold standard" endpoint in cancer clinical trials. It plays a key role in determining the clinical- and cost-effectiveness of a new intervention and whether it is recommended for use in standard of care. The assessment of overall survival usually requires trial participants to be followed up for a long period of time. In this time, they may stop receiving the trial intervention and receive subsequent anti-cancer treatments, which also aim to extend survival, during trial follow-up. This can potentially change the interpretation of overall survival in the context of the clinical trial. This review aimed to determine how overall survival has been assessed in cancer clinical trials and whether subsequent anti-cancer treatments are considered. Methods: Two searches were conducted using MEDLINE within OVID© on the 9th of November 2021. The first sought to identify papers publishing overall survival results from randomised controlled trials in eight reputable journals and the second to identify papers mentioning or considering subsequent treatments. Papers published since 2010 were included if presenting or discussing overall survival in the context of treating cancer. Results: One hundred and thirty-four papers were included. The majority of these were presenting clinical trial results (98, 73%). Of these, 45 (46%) reported overall survival as a (co-) primary endpoint. A lower proportion of papers including overall survival as a (co-) primary endpoint compared to a secondary endpoint were published in recent years. The primary analysis of overall survival varied across the papers. Fifty-nine (60%) mentioned subsequent treatments. Seven papers performed additional analysis, primarily when patients in the control arm received the experimental treatment during trial follow-up (treatment switching). Discussion: Overall survival has steadily moved from being the primary to a secondary endpoint. However, it is still of interest with papers presenting overall survival results with the caveat of subsequent treatments, but little or no investigation into their effect. This review shows that there is a methodological gap for what researchers should do when trial participants receive anti-cancer treatment during trial follow-up. Future research will identify the stakeholder opinions, on how this methodological gap should be addressed. [ABSTRACT FROM AUTHOR]

Peer review is the backbone of academia and humans constitute a cornerstone of this process, being responsible for reviewing submissions and making the final acceptance/rejection decisions. Given that human decision-making is known to be susceptible to various cognitive biases, it is important to understand which (if any) biases are present in the peer-review process, and design the pipeline such that the impact of these biases is minimized. In this work, we focus on the dynamics of discussions between reviewers and investigate the presence of herding behaviour therein. Specifically, we aim to understand whether reviewers and discussion chairs get disproportionately influenced by the first argument presented in the discussion when (in case of reviewers) they form an independent opinion about the paper before discussing it with others. In conjunction with the review process of a large, top tier machine learning conference, we design and execute a randomized controlled trial that involves 1,544 papers and 2,797 reviewers with the goal of testing for the conditional causal effect of the discussion initiator's opinion on the outcome of a paper. Our experiment reveals no evidence of herding in peer-review discussions. This observation is in contrast with past work that has documented an undue influence of the first piece of information on the final decision (e.g., anchoring effect) and analyzed herding behaviour in other applications (e.g., financial markets). Regarding policy implications, the absence of the herding effect suggests that the current status quo of the absence of a unified policy towards discussion initiation does not result in an increased arbitrariness of the resulting decisions. [ABSTRACT FROM AUTHOR]

Background: Monitoring is essential to ensure patient safety and data integrity in clinical trials as per Good Clinical Practice. The Standard Protocol Items: Recommendations for Interventional Trials Statement and its checklist guides authors to include monitoring in their protocols. We investigated how well monitoring was reported in published 'protocol papers' for contemporary randomised controlled trials. Methods: A systematic search was conducted in PubMed to identify eligible protocol papers published in selected journals between 1 January 2020 and 31 May 2020. Protocol papers were classified by whether they reported monitoring and, if so, by the details of monitoring. Data were summarised descriptively. Results: Of 811 protocol papers for randomised controlled trials, 386 (48%; 95% CI: 44%-51%) explicitly reported some monitoring information. Of these, 20% (77/386) reported monitoring information consistent with an on-site monitoring approach, and 39% (152/386) with central monitoring, 26% (101/386) with a mixed approach, while 14% (54/386) did not provide sufficient information to specify an approach. Only 8% (30/386) of randomised controlled trials reported complete details about all of scope, frequency and organisation of monitoring; frequency of monitoring was the least reported. However, 6% (25/386) of papers used the term 'audit' to describe 'monitoring'. Discussion: Monitoring information was reported in only approximately half of the protocol papers. Suboptimal reporting of monitoring hinders the clinical community from having the full information on which to judge the validity of a trial and jeopardises the value of protocol papers and the credibility of the trial itself. Greater efforts are needed to promote the transparent reporting of monitoring to journal editors and authors. [ABSTRACT FROM AUTHOR]

Focused Clinical Question: For postpartum primiparous women, will a 16-week, supervised, targeted pelvic floor muscle training program result in a reduced prevalence of diastasis recti abdominis versus education only at discharge? Clinical Bottom Line: We can neither recommend nor caution against a targeted pelvic floor muscle training program to reduce the prevalence of postpartum diastasis recti abdominis. [ABSTRACT FROM AUTHOR]

Abstract: This review summarises all trauma and related papers published in the British Journal of Oral and Maxillofacial Surgery (BJOMS) from January 2010 to December 2011. In total 45 articles were published, of which 42% (19) were full-length articles. These articles primarily focused on the management of mandibular condyle and orbital fractures, with several papers discussing maxillofacial surgery by the British military. There were no articles discussing midfacial fractures or massive facial trauma. The remaining papers included short communications, technical notes, and letters; and provided discussion of interesting cases, new surgical techniques and fracture classifications. The number of trauma papers published in BJOMS appears to be less than other sub-specialties such as head and neck oncology. The number of prospective and randomised studies remains low, highlighting a need to foster further research within maxillofacial trauma. [Copyright &y& Elsevier]

This paper discusses adapting Churches' approach to large-scale teacher/researcher conceptual replications of major "science of learning" findings, to increase teachers' engagement with empirical research on, and building research networks for, gathering data on the science of learning. The project here demonstrated the feasibility of teacher-led randomised controlled trials for conceptually replicating the effects of cognitive science on learning, as specified by researchers. It also indicated high levels of interest by teachers in applying more science of learning in their practice. The approach gave freedom to teachers to design interventions, choose research methods, and measure outcomes, even though such freedom would be in tension with some scientific research which relies on constraining the sources of variation. This paper discusses how a balance can be struck between the objectives of teachers and researchers engaged in replicating cognitive science findings, and promoting teacher engagement in conceptual replication research.

Background: It is widely acknowledged that children with developmental language disorder (DLD) predominantly have difficulties in the areas of grammar and vocabulary, with preserved pragmatic skills. Consequently, few studies focus on the pragmatic skills of children with DLD, and there is a distinct lack of studies examining the effectiveness of pragmatic interventions. Aims: To carry out a systematic review of the literature on pragmatic interventions for children with DLD. Methods & Procedures: This systematic review was registered with PROSPERO (ID = CRD42017067239). A systematic search in seven databases yielded 1031 papers, of which 11 met our inclusion criteria. The included papers focused on interventions for children with DLD (mean = 3-18 years), enhancing oral language pragmatic skills, published between January 2006 and May 2020, and were based on a group-study design such as randomized control trial or pre-post-testing. Study participants were monolingual speakers. The quality of papers was appraised using the Cochrane Risk of bias tool for randomized controlled trials. Outcomes & Results: There was a high degree of variability between the included intervention studies, especially regarding intensity, intervention targets and outcomes. The evidence suggested that pragmatic intervention is feasible for all models of delivery (individual, small and large group) and that interventions for pragmatic language are mostly focused on encouragement of conversation and narrative skills observed through parent-child interaction or shared book-reading activities. Conclusions & Implications: This study highlights the importance of promoting and explicitly teaching pragmatic skills to children with DLD in structured interventions. A narrative synthesis of the included studies revealed that in addition to direct intervention, indirect intervention can also contribute to improving oral pragmatic skills of children with DLD.

Objective: To determine whether paper tape prevents foot blisters in multistage ultramarathon runners. Design: Multisite prospective randomized trial. Setting: The 2014 250-km (155-mile) 6-stage RacingThePlanet ultramarathons in Jordan, Gobi, Madagascar, and Atacama Deserts. Participants: One hundred twenty-eight participants were enrolled: 19 (15%) from the Jordan, 35 (27%) from Gobi, 21 (16%) from Madagascar, and 53 (41%) from the Atacama Desert. The mean age was 39.3 years (22-63) and body mass index was 24.2 kg/m² (17.4-35.1), with 31 (22.5%) females. Interventions: Paper tape was applied to a randomly selected foot before the race, either to participants' blister-prone areas or randomly selected location if there was no blister history, with untaped areas of the same foot used as the control. Main Outcome Measures: Development of a blister anywhere on the study foot. Results: One hundred six (83%) participants developed 117 blisters, with treatment success in 98 (77%) runners. Paper tape reduced blisters by 40% (P< 0.01, 95% confidence interval, 28-52) with a number needed to treat of 1.31. Most of the study participants had 1 blister (78%), with most common locations on the toes (n = 58, 50%) and heel (n = 27, 23%), with 94 (80%) blisters occurring by the end of stage 2. Treatment success was associated with earlier stages [odds ratio (OR), 74.9, P < 0.01] and time spent running (OR, 0.66, P = 0.01). Conclusion: Paper tape was found to prevent both the incidence and frequency of foot blisters in runners. [ABSTRACT FROM AUTHOR]

Abstract: Research is an essential part of surgical training, so a surgical trainee must publish to prosper. The most important piece of advice is to seek expert help before commencing the process of research and subsequent publication. Having a piece of research worthy of communication to peers is an essential prerequisite, but there are many different types of publication, and many different avenues for publication. Starting with a simple case report is often a good beginning; publication in high-profile, high-impact-factor journals requires high-quality research such as randomized trials or systematic reviews. The more high profile the research, the more likely there are to be formal rules about its conduct and its publication (CONSORT, PRISMA etc). Writing in scientific English requires economy of style and linguistic restraint; many readers will not have English as a first language. By convention, scientific articles are written in IMRAD style – introduction, methods, results and discussion. This author has evolved a method to make writing a scientific manuscript as painless as possible. It may be tempting to relax once the writing is complete, but managing the paper through submission can also be challenging. Most journals will not accept a paper immediately, but will require corrections suggested by independent referees after formal peer review. All dealings with journal editors should be professional and courteous. [Copyright &y& Elsevier]

Abstract: This paper provides a summary of the 49 trauma and related papers published in British Journal of Oral and Maxillofacial Surgery during the period January 2008 to December 2009. 16/49 (32%) of these publications were full length articles, which covered areas such as epidemiology, service provision, materials and operative surgery. In addition there were other articles including short communications, technical notes, letters to the editor and interesting cases. Whilst fewer full length articles were published compared to the other sub-specialties, it was reassuring to see that the studies represent all aspects of trauma. More basic science and randomized control studies relating to trauma need to be encouraged. [ABSTRACT FROM AUTHOR]

The measurement of proglucagon-derived peptides (PGDPs) is a challenging task mainly due to major overlaps in their molecular sequence in addition to their low circulating levels. Here, we present the technical characteristics of novel ELISA assays measuring C-peptide and all six PGDPs including, for the first time, major proglucagon fragment (MPGF), and we validate them by performing a pilot in vivo cross-over randomized clinical trial on whether coffee consumption may affect levels of circulating PGDPs. The performance and technical characteristics of novel ELISA assays from Ansh measuring GLP-1, GLP-2, oxyntomodulin, glicentin, glucagon, MPGF and C-peptide were first evaluated in vitro in procured samples from a commercial vendor as well as in deidentified human samples from three previously performed clinical studies. Their performance was further evaluated in vivo in the context of a cross-over randomized controlled trial, in which 33 subjects consumed in random order and together with a standardized meal, 200 ml of either (a) instant coffee with 3 mg/kg caffeine, or (b) instant coffee with 6 mg/kg caffeine, (c) or water. All assays demonstrated high accuracy (spike and recovery and average linearity recovery ±15%), precision (inter-assay CV ≤ 6.4%), specificity (no significant cross-reactivities) and they were sensitive in low concentrations. Measurements of glicentin in archived random human samples using the Ansh assay correlated strongly with the glicentin measurements of Mercodia assay (r = 0.968) and of GLP-1 modestly with Millipore GLP-1 assay (r = 0.440). Oxyntomodulin, glicentin and glucagon concentrations were 2–5 fold higher in plasma compared to serum and serum concentrations correlated modestly (for oxyntomodulin and glicentin) or poorly (for glucagon) with the plasma concentrations. The evaluated assays detected a postprandial increase of gut-secreted PGDPs (GLP-1, GLP-2, oxyntomodulin and glicentin) and a postprandial decrease of pancreas-secreted PGDPs (glucagon, MPGF) in response to consuming coffee in comparison to consuming water with breakfast (enter here composition of breakfast). Only coffee consumption at the high dose alter levels of gut-secreted PGDPs and both at low and high dose to lower levels of pancreas-secreted PGDPs compared to water consumption during breakfast. Accurate, precise and specific measurement of six PGDPs is possible with novel assays. A randomized controlled trial demonstrated in vivo utility of those assays and supports the notion that coffee may exert part of its beneficial effects on glucose homeostasis in the short term through the regulation of PGDPs. • Sequences of PGDPs are overlapping and their low circulating levels make their measurement difficult. • Novel assays can perform an accurate, precise, and specific measurement of PGDPs. • Regulation of glucose homeostasis by coffee may occur through altering circulating levels of PGDPs. [ABSTRACT FROM AUTHOR]

Introduction: Non-compliance is a common challenge for researchers and may reduce the power of an intention-to-treat analysis. Whilst a per protocol approach attempts to deal with this issue, it can result in biased estimates. Several methods to resolve this issue have been identified in previous reviews, but there is limited evidence supporting their use. This review aimed to identify simulation studies which compare such methods, assess the extent to which certain methods have been investigated and determine their performance under various scenarios. Methods: A systematic search of several electronic databases including MEDLINE and Scopus was carried out from conception to 30th November 2022. Included papers were published in a peer-reviewed journal, readily available in the English language and focused on comparing relevant methods in a superiority randomised controlled trial under a simulation study. Articles were screened using these criteria and a predetermined extraction form used to identify relevant information. A quality assessment appraised the risk of bias in individual studies. Extracted data was synthesised using tables, figures and a narrative summary. Both screening and data extraction were performed by two independent reviewers with disagreements resolved by consensus. Results: Of 2325 papers identified, 267 full texts were screened and 17 studies finally included. Twelve methods were identified across papers. Instrumental variable methods were commonly considered, but many authors found them to be biased in some settings. Non-compliance was generally assumed to be all-or-nothing and only occurring in the intervention group, although some methods considered it as time-varying. Simulation studies commonly varied the level and type of non-compliance and factors such as effect size and strength of confounding. The quality of papers was generally good, although some lacked detail and justification. Therefore, their conclusions were deemed to be less reliable. Conclusions: It is common for papers to consider instrumental variable methods but more studies are needed that consider G-methods and compare a wide range of methods in realistic scenarios. It is difficult to make conclusions about the best method to deal with non-compliance due to a limited body of evidence and the difficulty in combining results from independent simulation studies. PROSPERO registration number: CRD42022370910. [ABSTRACT FROM AUTHOR]

Purpose: Surrogate outcomes are clinical endpoints that are used as substitutes for direct measures of how a patient feels, functions, or survives. The present study aims to analyze the impact of surrogate outcomes on the results of randomized controlled trials on shoulder rotator cuff tears disorders. Methods: Randomized controlled trials (RCTs) related to rotator cuff tear conditions published up until 2021 were retrieved from the PubMed and ACCESSSS databases. The primary outcome of the article was considered a surrogate outcome when the authors used radiological, physiologic, or functional variables. The result of the article was considered positive when results supported the intervention based on the trial's primary outcome. We recorded the sample size, the mean follow-up, and the type of funding. Statistical significance was set at p < 0.05. Results: A total of 112 papers were included in the analysis. The mean sample size was 87.6 patients; mean follow-up period was 25.97 months. Thirty-six out of 112 RCTs used a surrogate outcome as a primary endpoint. More than half of papers using surrogate outcomes reported a positive finding (20 out of 36), while 10 out of 71 RCTs using patient-centered outcomes favored the intervention (14.08%, p < 0.001) [RR = 3.94 (95% CI 2.07–7.51)]. The mean sample size was smaller in trials using surrogate endpoints (75.11 vs 92.35 patients, respectively, p = 0.049), while the follow-up was shorter (14.12 m vs. 31.9 m, p < 0.001). Approximately 25% of the papers that reported surrogate endpoints (22.58%) were industry-funded projects. Conclusions: The substitution of surrogate endpoints for patient-important outcomes in shoulder rotator cuff trials quadruplicates the chances of obtaining a favorable result that favors the analyzed intervention. [ABSTRACT FROM AUTHOR]