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Background: The Integrated Palliative Care Outcome Scale (IPOS) validly and reliably measures symptoms and concerns of those receiving palliative care. Aim: To determine the equivalence of the paper version with an electronic version of the IPOS (eIPOS). Design: Multicentre randomised crossover trial (NCT03879668) with a within-subject comparison of the two modes (washout period 30 min). Setting/Participants: Convenience sample of specialist inpatient and palliative home care patients aged over 18 years with cancer and non-cancer conditions was recruited. Scores were compared using intraclass correlation coefficients (ICC), Bland-Altman plots and via a mixed-effects analysis of variance. Results: Fifty patients were randomised to complete paper-electronic (n = 24) and electronic-paper (n = 26) IPOS with median age 69 years (range 24–95), 56% male, 16% non-cancer. The ICCs showed very high concordance for the total score (ICC 0.99, 95% CI 0.98–1.00), lowest ICCs being observed for symptoms 'Appetite loss' and 'Drowsiness' (ICC 0.95, 95% CI 0.92–0.97). Nine of seventeen items had ICCs above 0.98, as did all subscales. No statistically significant mode, order, age, and interaction effects were observed for IPOS total score and subscales, except for 'Communication' (Fmode = 5.9, p = 0.019). Fifty-eight percent preferred the electronic version. In the group 75+ years, 53% preferred the paper version. Only three entries in the free-text main problems differed between the versions. Conclusion: The very high equivalence in scores and free text between the IPOS and the eIPOS demonstrates that eIPOS is feasible and reliable in an older palliative population. [ABSTRACT FROM AUTHOR]

In people with bone and soft tissue injuries of the wrist, hand and/or fingers, do feedback-guided exercises performed on a tablet touchscreen hasten return to work, reduce healthcare usage and improve clinical recovery more than a home exercise program prescribed on paper? Randomised, parallel-group trial with concealed allocation, assessor blinding and intention-to-treat analysis. Seventy-four workers with limited functional ability due to bone and soft tissue injuries of the wrist, hand and/or fingers. Participants in the experimental and control groups received the same in-patient physiotherapy and occupational therapy. Participants in the experimental group received a home exercise program using the ReHand tablet application, which guides exercises performed on a tablet touchscreen with feedback, monitoring and progression. Participants in the control group were prescribed an evidence-based home exercise program on paper. The primary outcome was the time taken to return to work. Secondary outcomes included: healthcare usage (number of clinical appointments); and functional ability, pain intensity, and grip and pinch strength 2 and 4 weeks after randomisation. Compared with the control group, the experimental group: returned to work sooner (MD –18 days, 95% CI –33 to –3); required fewer physiotherapy sessions (MD –7.4, 95% CI –13.1 to –1.6), rehabilitation consultations (MD –1.9, 95% CI –3.6 to 0.3) and plastic surgery consultations (MD –3.6, 95% CI –6.3 to –0.9); and had better short-term recovery of functional ability and pinch strength. In people with bone and soft-tissue injuries of the wrist, hand and/or fingers, prescribing a feedback-guided home exercise program using a tablet-based application instead of a conventional program on paper hastened return to work and improved the short-term recovery of functional ability and pinch strength, while reducing the number of required healthcare appointments. ACTRN12619000344190 [ABSTRACT FROM AUTHOR]

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]

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]

Objective: To determine whether patients with stroke receiving rehabilitation for upper limb deficits using smart technology (video and reminder functions) demonstrate greater adherence to prescribed home exercise programmes and better functional outcomes when compared with traditional paper-based exercise prescription. Design: Randomized controlled trial comparing upper limb home exercise programmes supported by video and automated reminders on smart technology, with standard paper-based home exercise programmes. Setting: A community rehabilitation programme within a large metropolitan health service. Subjects: Patients with stroke with upper limb deficits, referred for outpatient rehabilitation. Interventions: Participants were randomly assigned to the control (paper-based home exercise programme) or intervention group (home exercise programme filmed on an electronic tablet, with an automated reminder). Both groups completed their prescribed home exercise programme for four weeks. Main measures: The primary outcome was adherence using a self-reported log book. Secondary outcomes were change in upper limb function and patient satisfaction. Results: A total of 62 participants were allocated to the intervention (n = 30) and control groups (n = 32). There were no differences between the groups for measures of adherence (mean difference 2%, 95% CI −12 to 17) or change in the Wolf Motor Function Test log transformed time (mean difference 0.02 seconds, 95% CI −0.1 to 0.1). There were no between-group differences in how participants found instructions (p = 0.452), whether they remembered to do their exercises (p = 0.485), or whether they enjoyed doing their exercises (p = 0.864). Conclusions: The use of smart technology was not superior to standard paper-based home exercise programmes for patients recovering from stroke. This trial design was registered prospectively with the Australian and New Zealand Clinical Trials Register, ID: ACTRN 12613000786796. http://www.anzctr.org.au/trialSearch.aspx [ABSTRACT FROM AUTHOR]

Background: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health informationprescriptions (HIPs) can be effectivelyintegrated into clinic workflow, but compliance to visit health information sites such as Medline Plus is limited.Objective: Compare the efficacy of paper (pHIP)and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs.Method: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information.Survey non-responders were contacted by telephone to determine the reasons for no response.Results: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most(82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites.Conclusions: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes. [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 reports the results of a hybrid effectiveness-implementation randomized trial that systematically varied levels of human oversight required to support the implementation of a digital medicine intervention for persons with mild-to-moderate alcohol use disorder (AUD). Participants were randomly assigned to three groups representing possible digital health support models within a health system: self-monitored use (SM; n = 185), peer-supported use (PS; n = 186), or a clinically integrated model CI; (n = 187). Across all three groups, the percentage of self-reported heavy drinking days dropped from 38.4% at baseline (95% CI [35.8%, 41%]) to 22.5% (19.5%, 25.5%) at 12 months. The clinically integrated group showed significant improvements in mental health and quality of life compared to the self-monitoring group (p = 0.011). However, higher attrition rates in the clinically integrated group warrant consideration in interpreting this result. Results suggest that making a self-guided digital intervention available to patients may be a viable option for health systems looking to promote alcohol risk reduction. This study was prospectively registered at clinicaltrials.gov on 7/03/2019 (NCT04011644). [ABSTRACT FROM AUTHOR]

Purpose: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life-Core Questionnaire (QLQ-C30) is a widely used generic self-report measure of health-related quality of life (HRQOL) for cancer patients. However, no validated voice script for interviewer-led telephone administration was previously available. The aim of this study was to develop a voice script for interviewer administration via telephone. Methods: Following guidelines from the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) PRO Mixed Modes Good Research Practices Task Force, a randomised cross-over equivalence study, including cognitive debriefing, was conducted to assess equivalence between paper and telephone administration modes. Assuming an expected intraclass correlation coefficient (ICC) of 0.70 and a minimally acceptable level of 0.50, a sample size of 63 was required. Results: Cognitive interviews with five cancer patients found the voice script to be clear and understandable. Due to a protocol deviation in the first wave of testing, only 26 patients were available for analyses. A second wave of recruitment was conducted, adding 37 patients (n = 63; mean age 55.48; 65.1% female). Total ICCs for mode comparison ranged from 0.72 (nausea and vomiting, 95% CI 0.48–0.86) to 0.90 (global health status/QoL, 95% CI 0.80–0.95; pain, 95% CI 0.79–0.95; constipation, 95% CI 0.80–0.95). For paper first administration, all ICCs were above 0.70, except nausea and vomiting (ICC 0.55; 95% CI 0.24–0.76) and financial difficulties (ICC 0.60; 95% CI 0.31–0.79). For phone first administration, all ICCs were above 0.70. Conclusions: The equivalence testing results support the voice script's validity for administration of the QLQ-C30 via telephone. [ABSTRACT FROM AUTHOR]

Background: Early language delay is exacerbated by social disadvantage. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. Methods used to achieve successful health outcomes in socially disadvantaged clinical populations may need enhancing. Aims: To compare the impact of standard parent‐based intervention (PBI) to enhanced PBI for young children with speech, language and communication needs (SCLN) and their families living in more socially disadvantaged populations. Methods and Procedures: A multicentre clustered blind randomised controlled trial was used to compare the effect of parent‐based group interventions to improve early language development with children (mean age 27.5 months) from more socially disadvantaged populations with an expressive vocabulary of 40 or less single words. Intervention sessions were delivered by a speech and language therapist, over a 20‐week period. Participants received one of two interventions: (1) Standard Care – indirect group PBI – (PBI) (2) Enhanced Care: indirect group enhanced PBI – (EPBI). Both standardised and non‐standardised measures were used as outcomes. Parent engagement in the intervention was captured through analysis of attendance and the Parent Activation Measure – Speech & Language Therapy (PAM‐SLT) (Insignia Health, 2014). The PAM measures a person's knowledge, skills and confidence to manage their own health and well‐being (NHS England, 2018). In this study, activation referred to parents' knowledge, skills and confidence to manage their child's language development. Outcomes and Results: One hundred fifty‐five participants were randomised at baseline. Children in both groups made significant improvements in the outcome on MacArthur‐Bates Communicative Development Inventories Sentence Length, from pre‐intervention to post‐intervention and 6 months post‐intervention (p < 0.05). Changes in vocabulary and expressive language skills were more equivocal, showing wide variation in confidence intervals for both groups. Where parents attended at least one intervention session almost all effect sizes were in favour of the EPBI intervention. Parents' activation levels significantly increased for both groups (EPBI p < 0.001, PBI p = 0.003), with a moderate effect size in favour of EPBI (Hedges' G 0.37, confidence interval –0.02 to 0.76), although wide variation was found. Conclusions and Implications: This trial provides some evidence of facilitating the language development of children with SLCN from more socially disadvantaged areas through supporting caregivers. However, we found variation in outcomes; some children made excellent progress, whilst others did not. Further exploration of parent engagement and its relationship to child language outcomes will be valuable to understanding more about mechanisms of change in interventions that involve parents. WHAT THIS PAPER ADDS: What is already known on the subject: Speech, language and communication needs (SLCN) have a knock‐on effect on emotional well‐being, school readiness, literacy and school attainment, putting children at increased risk of long‐term consequences such as poor literacy, mental health problems and unemployment. In disadvantaged areas, the prevalence of language difficulties is higher than elsewhere. Factors such as parents' low levels of literacy, confidence and self‐perception can affect the capacity to act on advice received, critical to empowerment. What this paper adds to existing knowledge: Children with SLCN from more socially disadvantaged areas can make improvements in their language development through parent intervention, although wide individual variation was found. There was some evidence that children achieve better outcomes with EPBI, which employed an interagency collaborative approach. Parent's engagement (activation levels) increased significantly over time with intervention, with the increase twice as big for EPBI. What are the potential or actual clinical implications of this work?: This trial provides some evidence that it is possible to facilitate the language development of children from more socially disadvantaged areas through supporting their caregivers. Further research would be useful to determine whether increases in parent engagement are related to adherence to intervention and change in child outcomes. [ABSTRACT FROM AUTHOR]

Background: Decisions regarding maintenance therapy in patients with multiple myeloma should be based on both treatment efficacy and health-related quality of life (HRQL) consequences. In the CARFI trial, patients with first relapse of multiple myeloma underwent salvage autologous stem cell transplantation (salvage ASCT) before randomization to carfilzomib-dexamethasone maintenance therapy (Kd) or observation. The primary clinical endpoint was time to progression, which was extended by 8 months by Kd. The aim of this paper is to present the all HRQL endpoints of the CARFI trial including the HRQL effect of Kd maintenance therapy relative to observation. The primary HRQL endpoint was assessed by EORTC QLQ-C30 Summary score (QLQ-C30-sum) at 8 months follow-up. A key secondary HRQL endpoint was quality-adjusted progression-free-survival (QAPFS). Methods: HRQL was assessed with EORTC QLQ-C30, EORTC QLQ-MY20 and FACT/GOG-Ntx at randomization and every second month during follow-up. HRQL data were analyzed with linear mixed effect models until 8 months follow-up. QAPFS per individual was calculated by multiplying progression-free survival (PFS) by two quality-adjustment metrics, the QLQ-C30-sum and EORTC Quality of Life Utility Measure-Core 10 dimensions (QLU-C10D). The QAPFS per treatment group was estimated with the Kaplan-Meier method. P < 0.05 was used for statistical significance, and a between-group minimal important difference of 10 points was interpreted as clinically relevant for the QLQ-C30-sum. Results: 168 patients were randomized. HRQL questionnaire compliance was 93%. For the QLQ-C30-sum, the difference of 4.62 points (95% confidence interval (CI) -8.9: -0.4, p = 0.032) was not clinically relevant. PFS was 19.3 months for the Kd maintenance group and 16.8 months for the observation group; difference = 2.5 months (95% CI 0.5; 4.5). QAPFS based on the QLQ-C30-sum for the Kd maintenance group was 18.0 months (95% CI 16.4; 19.6) and for the observation group 15.0 months (95% CI 13.5; 16.5); difference = 3.0 months (95% CI 0.8–5.3). QAPFS based on the QLU-C10D for the Kd maintenance group was 17.5 months (95% CI 15.9; 19.2) and 14.0 months (95% CI 12.4; 15.5) for the observation group; difference = 3.5 months (95% CI 1.1–5.9). Conclusions: Kd maintenance therapy after salvage ASCT did not adversely affect overall HRQL, but adjustment for HRQL reduced the PFS compared to unadjusted PFS. PFS of maintenance therapy should be quality-adjusted to balance the benefits and HRQL impact. [ABSTRACT FROM AUTHOR]

This paper provides an in-depth study of occupational therapy and the prevention of common sports injuries in special physical training. The issue of sports injuries and rehabilitation has always been a hot topic in special training. With the continuous development of sports, the increasing intensity of competition, and more stringent requirements for special techniques, the increase in difficulty and intensity of training has led to the increasing frequency of sports injuries, so how to prevent injuries in special physical training and rehabilitation and recovery of athletes after the injury is particularly important. Since the most common musculoskeletal injuries occur in the lower quadrant, this paper proposes a lower extremity functional test (LEFT) model as a means of identifying injury risk and guiding the implementation of training programs to prevent sports injuries. In this paper, a knee injury is used as an example, and an occupational therapy program of TCM physical therapy + aquatic rehabilitation is adopted for the already occurred sports injuries. Through interviews and clinical examinations of athletes, coaches, and medical personnel, this paper summarizes the sites, types, characteristics, and probability of occurrence of common sports injuries in special physical training. Experiments were conducted through clinical rehabilitation of common sports injuries with the addition of TCM manual massage. A series of effects of this modality on the rehabilitation of sports injuries were examined by monitoring physiological and biochemical indexes and by comparative analysis before and after testing physical function indexes using the Omega Wave system. Sports injuries are diverse. Traditional Chinese medicine physical therapy + water rehabilitation therapy is an effective physical therapy method. According to the relevant theories of traditional Chinese medicine treatment, diagnosis and treatment through meridians and related acupuncture points have significant curative effects. Traditional Chinese medicine, massage, and acupuncture have irreplaceable roles in the rehabilitation and treatment of sports injuries and can effectively improve and cure sports injuries. [ABSTRACT FROM AUTHOR]

Background: Despite pervasive need for peripheral intravenous catheters, insertion is often difficult, and approximately two thirds fail prematurely. Midline catheters are an alternative long peripheral catheter, inserted in the upper arm, ideal for patients with difficult access. Aim: The aim of this study is to test feasibility of the protocol and compare the efficacy and safety of midline catheters to peripheral intravenous catheters. Design: A parallel‐group, pilot randomized controlled trial of adult medical/surgical hospitalized patients, from a single Australian referral hospital. Methods: Participants with difficult vascular access (≤2 palpable veins) and/or anticipated ≥5 days of peripherally compatible intravenous therapy were recruited between May 2019 and March 2020. Participants were randomized to (1) peripheral intravenous catheter or (2) midline catheter. Primary feasibility outcome measured eligibility, recruitment, protocol adherence, retention and attrition. Primary clinical outcomes measured device insertion failure and post‐insertion failure. Results: In total, n = 143 participants (71 peripheral intravenous catheters and 72 midline catheters) were recruited; n = 139 were analysed. Most feasibility criteria were met. Peripheral intravenous catheters had shorter functional dwell time, with higher incidence of post‐insertion failure compared to midline catheters. Conclusion: Midline catheters appear to be superior for patients with difficult vascular access or receiving prolonged intravenous therapy; a large, multi‐centre trial to confirm findings is feasible. Summary statement: What is already known about this topic? Peripheral intravenous catheters have endemically high incidence of complications.Midline catheters have been proposed as an alternative peripheral intravenous device, following recent advancements in catheter material and design.Few studies have compared safety and efficacy of contemporary midline catheters with peripheral intravenous catheters. What this paper adds: Midline catheters had a longer functional dwell time and lower incidence of post insertion‐failure, compared to peripheral intravenous catheters.Midline catheters appear safe; however, inserter skill appears to have critical influence on insertion success. The implications of this paper: This study established the feasibility and importance of a large, multicentre, randomized controlled trial to confirm findings.Future research should also focus on financial impacts, including cost‐efficiency.Policy makers should consider training specialist inserters to place midline catheters. [ABSTRACT FROM AUTHOR]

Introduction: Uncertainty exists regarding the best method for teaching thrust joint manipulation (TJM) to student physical therapists. The purpose of this study was to compare the effectiveness of Peyton's 4-step (P4) approach with the "see one, do one" (S1D1) approach for teaching students to perform a lumbar spine TJM task in an academic setting. Secondary objectives were to compare the effects of each instructional approach on students' attitudes and beliefs toward spinal TJM and on their motivation to learn to perform lumbar spine TJM. Review of literature: The S1D1 approach is used in the health care professions for teaching clinical tasks to students. It is unclear whether the P4 approach may better prepare students to practice TJM. Subjects: Student physical therapists. Methods: Using a factorial quasi-experimental design, an equal number of students were assigned to a P4 or S1D1 instruction group for the TJM task. Students' performance accuracy, time, and outcome performing TJM in an academic setting were measured. Paper surveys were used to collect data about students' attitudes and beliefs toward spinal TJM and their motivation to learn TJM. A generalized estimating equations approach was used for data analysis. Results: Fifty-eight students (29 per group) completed the study. There was an interaction between the instruction group and time on task performance accuracy favoring the P4 approach (P = .03). There was no interaction between the instruction group and task performance time, task performance outcome, attitudes and beliefs toward spinal TJM, or motivation to learn TJM (all P > .19). Discussion and conclusion: The P4 approach more effectively improved student accuracy when performing the TJM task in an academic setting than the S1D1 approach. However, no differences between instruction were found for performance time or outcome. Students reported a favorable perception of learning lumbar spine TJM. These preliminary results suggest that instructors may use the P4 approach to improve students' TJM procedural knowledge before task practice. However, limitations of the study may affect the internal validity and generalizability of results. [ABSTRACT FROM AUTHOR]

Introduction: Media comparison studies examining the effectiveness of immersive virtual reality in education have yielded inconclusive findings, leaving the question of its impact on learning compared to conventional media unanswered. To address this issue, our study employs a novel approach that combines media comparison with an investigation on the influence of broader educational context. Methods: In the experiment, 262 students from two distinct types of lower secondary schools—comprehensive school and multi‐year gymnasium (a selective academic school)—participated. The students received a lesson on topography and contour line interpretation, using either an immersive virtual environment or a PowerPoint slideshow. A transfer test was carried out before, immediately after, and 1 month after the lesson to measure knowledge application. Results: The impact of the media (immersive virtual reality vs. PowerPoint slideshow) on learning outcomes was found to be minimal, with no clear advantage of one over the other in any experimental condition. In contrast, a significant influence on learning gains was observed due to school type. Multi‐year gymnasium students consistently outperformed comprehensive school students in the pre‐test and demonstrated greater learning gains, regardless of the learning media. Conclusion: The present study employs an innovative approach by integrating a comparative analysis of different media types with an investigation into the impact of learner characteristics. By including students from distinct types of schools, the study provides insights into the differential effects of immersive virtual reality in varied educational contexts. Lay Description: What is already known about this topic: Media comparison studies typically assess the effectiveness of immersive virtual reality as a learning medium in comparison to other instructional methods in education.The findings of these studies differ markedly.Numerous factors impact learning outcomes in an immersive virtual environment. What this paper adds: Recommendation that research in the field should explore not only if but also when and how IVR learning is effective.Evidence that learning achievements may not be affected by the medium used.Evidence that the type of school can significantly influence learning gains.Evidence that cognitive dispositions, such as spatial abilities, can be another factor that influence learning outcomes. Implications for practice: A technology‐centred approach alone does not allow for a proper evaluation of the learning gain potential of IVR, learner characteristics and broader educational context should also be taken into account.IVR as a learning medium may not be appropriate for all students and every educational setting.To ensure reliable evaluation of learning gains, it is necessary to align the content and format of the intervention in both learning mediums as closely as possible.Measuring learning gains not only immediately after the intervention but also with a significant time delay can contribute to a more comprehensive understanding. [ABSTRACT FROM AUTHOR]

An infinite number of fitness apps are available on various app stores. However, hardly any of them are fitted to the needs and requirements of care‐dependent people. This paper investigates the effectiveness of a customised fitness‐app prototype for increasing physical activity in home care service users. Home care service users from Austria and Italy were randomly assigned to two groups. In total, 216 participants were involved in the field trial, 104 received a tablet with the fitness app and an activity tracker (treatment group), 112 did not (control group). Regularity of physical activity, frequency of fitness exercises and walking behaviour were self‐reported by participants at baseline, after 4 months and after 8 months. In addition, the frequency of using the prototype was assessed based on the fitness app's logged usage data. We estimated multilevel mixed‐effects ordered logistic models to examine the effects of the intervention. After 4 months, the intervention increased the home care users' probability of agreeing strongly with being physically active on a regular basis by 28 percentage points (p < 0.001; 95% CI: 0.20, 0.36) and their probability of reporting to exercise more than once a week by 45 percentage points (p < 0.001; 95% CI: 0.32, 0.57). Walking behaviour was not affected on group‐level but improved for frequent users of the activity tracker. Frequent and regular users of the fitness app benefited most and effects persisted until the end of the 8 months controlled trial. Tailoring a fitness‐app prototype to the needs of care‐dependent people has the potential to support people with functional limitations to engage in a more active lifestyle. Future research is encouraged to seek further insights into how new technologies can support physical activities in people with long‐term care needs. [ABSTRACT FROM AUTHOR]

Aims: To investigate the efficacy of pre‐emptive remifentanil in alleviating pain during tracheal suctioning in patients under mechanical ventilation. Background: Goal‐directed sedation is recommended for patients under mechanical ventilation by the current guidelines. Whether goal‐directed sedation can prevent pain during tracheal suctioning in these patients is unknown. Design: This was a two‐centre, randomized, crossover, single‐blind trial conducted between August and October 2019. Methods: Patients under mechanical ventilation received low‐dose remifentanil, high‐dose remifentanil or placebo prior to each tracheal suctioning in a random order. The primary outcomes were evaluated using the critical‐care pain observation tool and Richmond agitation–sedation scale after tracheal suctioning. Adverse events were also documented. Results: A total of 39 patients who underwent 117 tracheal suctions were enrolled. After the tracheal suction, changes in the critical‐care pain observation tool and Richmond agitation–sedation scale scores were significantly lower in the low‐dose and high‐dose groups than in the placebo group (P < 0.001). A non‐significant increase in the absence of spontaneous breathing was observed in the high‐dose group compared to that in the placebo group. Conclusion: A pre‐emptive remifentanil bolus of 0.5 μg/kg can mitigate the pain associated with tracheal suctioning. SUMMARY STATEMENT: What is already known about this topic? Pre‐emptive analgesia is recommended by several guidelines to alleviate the pain associated with invasive and potentially painful procedures in ICU patients.Goal‐directed sedation can shorten the length of hospital stay and is recommended for patients in the ICU by several clinical practice guidelines.Literature regarding whether goal‐directed sedation management or pre‐emptive remifentanil can prevent the pain associated with tracheal suctioning in patients under mechanical ventilation is scarce. What this paper adds? A pre‐emptive remifentanil bolus of 0.5 μg/kg can mitigate the pain associated with tracheal suctioning. The implications of this paper: Normal opioid doses administered for goal‐directed sedation management might be insufficient to prevent the pain associated with tracheal suctioningPre‐emptive analgesia can alleviate the pain without increasing the risk of opioid‐related adverse events in ICU patients under mechanical ventilation. [ABSTRACT FROM AUTHOR]

Background: Cardiovascular disease (CVD) is a major global health concern, the leading cause of death and disability. Thus, preventive interventions targeting modifiable risk factors are essential. Mobile-health technologies have emerged as promising tools for improving prevention by modifying risk factors. We created the "Green Heart" mobile app to help coronary artery disease (CAD) patients control their risk factors. The app has three modules: smoking cessation, dyslipidemia (DLP) control, and blood pressure (BP) management. This study evaluated the app's performance in monitoring hypertension (HTN) and DLP among known CAD cases. Methods: A randomized controlled trial enrolled 1590 CAD subjects, including 1114 hypertensive patients and 1488 subjects with DLP, and assigned them randomly to paper-based education or application-based groups. Results: Regarding HTN, after 6 months, we finally analyzed 545 and 546 hypertensive patients, assigned to the conventional and app groups, respectively. Patients in the app group were more likely to have their BP managed successfully (88.6% vs. 78.5%; P < 0.001). The app group showed higher odds of successful BP management (odds ratio [OR]: 2.13; 95% CI: 1.51 - 3.03). Regarding DLP, we analyzed 728 patients in the conventional and 714 patients in the app group. A higher percentage of patients in the app group (24.8%) had low-density lipoprotein cholesterol (LDL-C) levels less than 70 mg/dL (16.1%; P < 0.001). The app group showed higher odds of reducing LDL-C (OR: 1.72; 95% CI: 1.32--2.26). Conclusion: We found that using the Green Heart app in the self-monitoring setting significantly improved BP and DLP management across the study population. [ABSTRACT FROM AUTHOR]

INTRODUCTION Maternal smoking during pregnancy disturbs fetal lung development, and induces in their offspring childhood respiratory diseases. Whether it has a continued impact on offspring adult lung health and exerts a casual effect of chronic respiratory diseases (CRDs), remains uncertain. We seek to determine the causal relationships between maternal smoking around birth and offspring adult CRDs, using summary data from previously described cohorts. METHODS Mendelian randomization (MR) study was used to analyze the genome-wide associations of maternal smoking around birth and offspring adult CRDs, including respiratory insufficiency, chronic obstructive pulmonary disease (COPD), related respiratory insufficiency, emphysema, COPD, COPD hospital admissions, early onset of COPD, later onset of COPD, asthma, idiopathic pulmonary fibrosis (IPF), lung cancer (LC), small cell lung carcinoma (SCLC), and lung squamous cell carcinoma (LUSC). RESULTS After removing single-nucleotide polymorphisms (SNPs) associated with smoking by the offspring, maternal smoking around birth was associated with increased risk of offspring adult respiratory diseases (OR=1.14; 95% CI: 1.013-1.284; p=0.030), respiratory insufficiency (OR=2.413; 95% CI: 1.039-5.603; p=0.040), COPD (OR=1.14; 95% CI: 1.013-1.284; p=0.003), and asthma (OR=1.336; 95% CI: 1.161-1.538; p<0.001). Besides, maternal smoking during pregnancy was associated with a greater risk of LUSC (OR=1.229; 95% CI: 0.992-1.523; p=0.059) than the risk of IPF (0R=1.001; 95% CI: 0.999-1.003; p=0.224), LC (0R=1.203; 95% CI: 0.964-1.501; p=0.103), or SCLC (OR=1.11; 95% CI: 0.77-1.601; p=0.577). CONCLUSIONS In this MR analysis, maternal smoking around birth caused a strong risk factor for the offspring to develop lung problems and CRDs in adulthood. The policy related to smoking cessation for mothers during pregnancy should be encouraged. [ABSTRACT FROM AUTHOR]

This systematic review evaluated the impact of oral probiotics on the immune response to vaccination in older people. A literature search was performed in three electronic databases up to January 2023. Randomised controlled trials (RCTs) conducted in older people (age ≥ 60 years) investigating oral probiotics and vaccine response outcomes were included. Characteristics and outcome data of the included studies were extracted and analysed and study quality was assessed using the Cochrane Risk of Bias Tool for randomised trials. Ten RCTs involving 1,560 participants, reported in 9 papers, were included. Nine studies involved the seasonal influenza vaccine and one a COVID-19 vaccine. All studies used lactobacilli, some in combination with bifidobacteria. Studies reported outcomes including anti-vaccine antibody titres or concentrations, seroconversion and seroprotection. When comparing antibody titres, seroprotection rate and seroconversion rate between probiotic and placebo groups expressed as a response ratio, the weighted mean values were 1.29, 1.16 and 2.00, respectively. Meta-analysis showed that probiotics increase seroconversion rates to all three strains of the seasonal influenza vaccine: odds ratio (95% confidence interval) 2.74 (1.31, 5.70; P  = 0.007) for the H1N1 strain; 1.90 (1.04, 3.44; P  = 0.04) for the H3N2 strain; 1.72 (1.05, 2.80; P  = 0.03) for the B strain. There was a low level of heterogeneity in these findings. Several studies were at high risk of bias due to missing outcome data. Lactobacilli may improve the vaccine response, but further research is needed to be more certain of this. [ABSTRACT FROM AUTHOR]

INTRODUCTION Withdrawal symptoms lead to smoking relapse and reduce the intention to quit. The present pilot RCT examined the effect of simple and very brief handgrip and isometric exercises on reducing withdrawal symptoms, measured by the strength of tobacco craving, Questionnaire of Smoking Urges-Brief (QSU-B), Mood and Physical Symptoms Scale (MPSS), and Positive and Negative Affect Schedule (PANAS). METHODS In this 2-arm, open-labeled pilot RCT, 30 current smokers who had abstained from tobacco for at least 9 hours were randomly assigned (allocation ratio 1:1) to either the intervention group that watched a 5-minute video and did 5-minute handgrip and isometric exercises (pulling and pushing) or control group that watched 10-minute healthy-diet videos. Measurements were taken before, immediately after, and 10 minutes post-intervention. Outcomes were self-reported strength of tobacco craving, QSU-B, MPSS, and PANAS scores. The effect size for group-by-time interaction was assessed using Cohen's f² (small=0.02, medium=0.15, large=0.35). RESULTS Group-by-time interactions showed that the intervention group showed larger reductions than the control group in the strength of tobacco craving (Cohen's f²=0.54, 95% CI: 0.52-0.57), QSU-B (Cohen's f²=0.77; 95% CI: 0.74-0.80), and MPSS (Cohen's f²=0.51; 95% CI: 0.46-0.56) over the three measurement points. CONCLUSIONS This RCT showed that simple and brief handgrip and isometric exercises could immediately reduce withdrawal symptoms and up to 10 minutes. CLINICAL TRIAL REGISTRATION: in https://clinicaltrials.gov/IDENTIFIER: NCT04059497 [ABSTRACT FROM AUTHOR]

Background: Limited data regarding the effects of school-based obesity prevention programs focusing on the changes in obesity-related knowledge and behaviors in China are available. The objective of this paper was to evaluate the effects of a school-based comprehensive lifestyle intervention among Chinese kids against obesity (CLICK-Obesity) in primary schools in Nanjing. Methods: We designed a cluster randomized controlled trial in eight randomly selected urban primary schools among 4th graders between May 2011 to April 2012 in Jianye, an urban district of Nanjing. Each school was randomly assigned to either the intervention or control group (four schools in each group). Mixed regression models and generalized estimating equations (GEE) were used to adjust for individual-level covariates under cluster randomization. Results: In this study, 1178 students (96.2%; 665 boys and 513 girls, 544 in control and 634 in intervention) participated in the baseline survey with mean age 10.2 ± 0.5 years. At the end of one-year intervention, 1125 students (91.8%; 628 boys and 497 girls, 513 in control and 612 in intervention) were reassessed. Notably, we found that the intervention group improved the knowledge and awareness of obesity-related risk factors, presented a lower increase of consumption of red/white meat (with a mean difference of −180.9 g/week, 95% CI: −350.6 to −11.2, p = 0.040), a larger increase in the time spent playing ball (with a mean difference of 24.2 min/week, 95% CI: −5.3 to 53.7, p = 0.090), and a significant reduction in screen time (with a mean difference of −71.0 min/week, 95% CI: −125.3 to −16.6, p = 0.020) compared to the control group after cluster (school) adjustment. Conclusion: The school-based integrated intervention was successful to modify unhealthy lifestyle behaviors and had a potential effect on childhood obesity prevention in urban China. However, the long-term effects and cost-effectiveness need to be evaluated in through further study. [ABSTRACT FROM AUTHOR]

The herbal medicine Yukgunja-tang has been widely used for the treatment of functional dyspepsia (FD) in the clinical setting of East Asian traditional medicine. This paper presents a protocol for a randomized, assessor-blind, controlled, multicenter, three-arm parallel clinical trial comparing the effectiveness, safety, and cost-effectiveness of Yukgunja-tang with Pyeongwi-san and usual care. A total of 140 participants with Rome IV-diagnosed FD will be randomly assigned to either the Yukgunja-tang (n = 56), Pyeongwi-san (n = 56), or usual care (n = 28) groups. All participants will be educated on dietary guidelines for FD patients. Participants in the Yukgunja-tang and Pyeongwi-san groups will take investigational products for 6 weeks. All participants will be assessed for clinical parameters at weeks 0, 3, 6, 9, and 24. The primary outcome will be measured on the total dyspepsia symptom scale, and the secondary outcome will include the single dyspepsia symptom scale, overall treatment effect, the visual analog scale for dyspepsia, FD-related quality of life, hospital anxiety and depression scale, EuroQol-5 dimension, pattern identification, and serum levels of acyl-ghrelin and deacyl-ghrelin. Adverse events and laboratory tests will be monitored for safety assessment. The results will provide evidence of the effectiveness, safety, and cost-effectiveness of Yukgunja-tang in the treatment of FD. [ABSTRACT FROM AUTHOR]

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Background: Contrasting the well-described effects of early intervention (EI) services for youth-onset psychosis, the potential benefits of the intervention for adult-onset psychosis are uncertain. This paper aims to examine the effectiveness of EI on functioning and symptomatic improvement in adult-onset psychosis, and the optimal duration of the intervention. Methods: 360 psychosis patients aged 26–55 years were randomized to receive either standard care (SC, n = 120), or case management for two (2-year EI, n = 120) or 4 years (4-year EI, n = 120) in a 4-year rater-masked, parallel-group, superiority, randomized controlled trial of treatment effectiveness (Clinicaltrials.gov: NCT00919620). Primary (i.e. social and occupational functioning) and secondary outcomes (i.e. positive and negative symptoms, and quality of life) were assessed at baseline, 6-month, and yearly for 4 years. Results: Compared with SC, patients with 4-year EI had better Role Functioning Scale (RFS) immediate [interaction estimate = 0.008, 95% confidence interval (CI) = 0.001–0.014, p = 0.02] and extended social network (interaction estimate = 0.011, 95% CI = 0.004–0.018, p = 0.003) scores. Specifically, these improvements were observed in the first 2 years. Compared with the 2-year EI group, the 4-year EI group had better RFS total (p = 0.01), immediate (p = 0.01), and extended social network (p = 0.05) scores at the fourth year. Meanwhile, the 4-year (p = 0.02) and 2-year EI (p = 0.004) group had less severe symptoms than the SC group at the first year. Conclusions: Specialized EI treatment for psychosis patients aged 26–55 should be provided for at least the initial 2 years of illness. Further treatment up to 4 years confers little benefits in this age range over the course of the study. [ABSTRACT FROM AUTHOR]

Background: Web-based self-help interventions for parents of children with ADHD and other externalizing disorders have been proven to be effective. In order to recommend individualized and optimized interventions, a better understanding of the acceptance and utilization of this innovative treatment approach is needed. Previous research has frequently employed subjective reports of utilization, but the validity of these studies may be limited. Methods: Data from the German WASH study were used. Participants (n = 276) were randomly assigned to the intervention condition (a) web-based self-help or (b) web-based self-help with optional telephone-based support calls. Data collection took place at baseline (T1) and 12 weeks later (T2). Utilization data were tracked using a log file generated for each participant at T2. Prediction models were calculated using CART (Classification and Regression Trees), a method known mostly from the field of machine learning. Results: Acceptance, of the intervention as defined in this paper was very high on objective (89.4% have taken up the intervention) and subjective measures (91.4% reported having used the intervention and 95.3% reported they would recommend the intervention to a friend). The average number of logins corresponded to recommendations. Predictors of acceptance and predictors of utilization were similar and included, e.g., child's externalizing symptoms, parental psychopathology, and above all additional telephone-based support by counselors. Conclusions: Through a detailed identification of acceptance and utilization, and the predictors thereof, we were able to gain a better understanding of the acceptance and utilization of web-assisted self-help for a parent management intervention in the treatment of children with ADHD and ODD. These findings can be used to recommend web-based interventions to particularly suitable families. It should be noted that some form of support is required for an intensive engagement with the content of the program. Trial Registration: The protocol of the study (German Clinical Trials Register DRKS00013456 conducted on January 3rd, 2018) was approved by the Ethics Committee of the University Hospital, Cologne. [ABSTRACT FROM AUTHOR]

Objective: Few studies evaluated low concentrations of hydrogen peroxide protocols. The aim of this paper was evaluated two application protocols using 4% hydrogen peroxide in at‐home bleaching. Materials and Methods: Eighty‐six patients with upper canines' shade A2 or darker were randomly allocated under two experimental conditions: two daily applications of 1 h each or a 2‐h single application. Color change was evaluated using Vita Classical, Vita Bleachedguide, and digital spectrophotometer weekly and 1 month after the bleaching procedure through one‐way ANOVA. The risk and intensity of tooth sensitivity (TS) was assessed through visual and numeric rating scale and measured by Fisher's exact test, Mann–Whitney test and one‐way ANOVA respectively. Results: After 3 weeks, the mean difference for the ΔSGU Vita Classical (1.0; 95% CI −0.1 to 2.0), ΔEab (0.7; 95% CI −1.4 to 2.8), ΔE00 (0.1; 95% CI −1.4 to 1.6) and Wi (1.8; 95% CI ‐1.9 to 5.5) presented no difference (p > 0.08). The relative risk for TS was 0.91 (0.72 to 1.14) without significant difference neither in the risk (p = 0.6) nor in the TS intensity for both pain scales (p > 0.65). Conclusions: The application protocols evaluated (two daily applications of 1 h each or a 2‐h single application) for at‐home bleaching with 4% hydrogen peroxide did not showed differences in color change and tooth sensitivity. Clinical Relevance: Higher amount of active hydrogen peroxide in two daily applications for at‐home bleaching neither accelerate bleaching nor increase the risk or intensity of tooth sensibility. [ABSTRACT FROM AUTHOR]

INTRODUCTION Smoking cessation is the best strategy for reducing tobacco-related morbimortality. The goal of this randomized controlled trial was to test whether using the genetically favorable markers to choose a smoking cessation drug treatment (precision medicine) was superior to using the most effective drug (varenicline) in terms of abstinence rates. Additionally, combination therapy was tested when monotherapy failed. METHODS This partially blind, single-center study randomized (1:1) 361 participants into two major groups. In the genetic group (n=184), CYP2B6 rs2279343 (genotype AA) participants started treatment with bupropion, and CHRNA4 rs1044396 (genotype CT or TT) participants started treatment with varenicline; when genetic favorable to both, participants started treatment with bupropion, and when favorable to neither, on both drugs. In the control group (n=177), participants started treatment with varenicline, regardless of genetic markers. Drug treatment lasted 12 weeks. Efficacy endpoints were abstinence rates at Weeks 4, and Weeks 8-12, biochemically validated by carbon monoxide in exhaled air. Participants who did not achieve complete abstinence at Week 4, regardless of group, were given the choice to receive combination therapy. RESULTS Abstinence rates were 42.9% (95% CI: 36-64) in the control group versus 30.4% (95% CI: 23-37) in the genetic group at Week 4 (p=0.01); and 74% (95% CI: 67-80) versus 52% (95% CI: 49-64) at Week 12 (p<0.001), respectively. The strategy of combining drugs after Week 4 increased abstinence rates in both groups and the significant difference between genetic and control groups was maintained. CONCLUSIONS Results show that using these selected genetic markers was inferior to starting treatment with varenicline (control group), which is currently the most effective smoking cessation drug; moreover, the addition of bupropion in cases of varenicline monotherapy failure improves the efficacy rate until the end of treatment. CLINICAL TRIAL IDENTIFIER: NCT03362099 [ABSTRACT FROM AUTHOR]

INTRODUCTION Whether men find it easier to quit smoking than women is still controversial. Different studies have reported that the efficacy of pharmacological treatments could be different between men and women. This study conducted a secondary analysis of 'Subsidized pharmacological treatment for smoking cessation by the Spanish public health system' (FTFT-AP study) to evaluate the effectiveness of a drug-funded intervention for smoking cessation by gender. METHODS A pragmatic randomized clinical trial by clusters was used. The population included smokers aged ≥18 years, smoking >10 cigarettes per day, randomly assigned to an intervention group receiving regular practice and financed pharmacological treatment, or to a control group receiving only regular practice. The main outcome was continued abstinence at 12 months, self-reported and validated with CO-oximetry. The percentage, with 95% confidence intervals, of continued abstinence was compared between both groups at 12 months postintervention, by gender and the pharmacological treatment used. Multilevel logistic regression analysis was performed. RESULTS A total of 1154 patients from 29 healthcare centers were included. The average age was 46 years (SD=11.78) and 51.7% were men. Overall, the selfreported abstinence at 12 months was 11.1% (62) in women and 15.7% (93) in men (AOR=1.4; 95% CI: 1.0--2.0), and abstinence validated by CO-oximetry was 4.6% (26) and 5.9% (35) in women and men, respectively (OR=1.3; 95% CI: 0.7-2.2). In the group of smokers receiving nicotine replacement treatment, self-reported abstinence was higher in men compared to women (29.5% vs 13.5%, OR=2.7; 95% CI: 1.3-5.8). CONCLUSIONS The effectiveness of a drug-financed intervention for smoking cessation was greater in men, who also showed better results in self-reported abstinence with nicotine replacement treatment. [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]

Electronic medication management (eMM) systems are designed to improve safety, but there is little evidence of their effectiveness in paediatrics. This study assesses the short-term (first 70 days of eMM use) and long-term (one-year) effectiveness of an eMM system to reduce prescribing errors, and their potential and actual harm. We use a stepped-wedge cluster randomised controlled trial (SWCRCT) at a paediatric referral hospital, with eight clusters randomised for eMM implementation. We assess long-term effects from an additional random sample of medication orders one-year post-eMM. In the SWCRCT, errors that are potential adverse drug events (ADEs) are assessed for actual harm. The study comprises 35,260 medication orders for 4821 patients. Results show no significant change in overall prescribing error rates in the first 70 days of eMM use (incident rate ratio [IRR] 1.05 [95%CI 0.92–1.21], but a 62% increase (IRR 1.62 [95%CI 1.28–2.04]) in potential ADEs suggesting immediate risks to safety. One-year post-eMM, errors decline by 36% (IRR 0.64 [95%CI 0.56–0.72]) and high-risk medication errors decrease by 33% (IRR 0.67 [95%CI 0.51–0.88]) compared to pre-eMM. In all periods, dose error rates are more than double that of other error types. Few errors are associated with actual harm, but 71% [95%CI 50–86%] of patients with harm experienced a dose error. In the short-term, eMM implementation shows no improvement in error rates, and an increase in some errors. A year after eMM error rates significantly decline suggesting long-term benefits. eMM optimisation should focus on reducing dose errors due to their high frequency and capacity to cause harm. [ABSTRACT FROM AUTHOR]

Background: The development and promotion of educational games are still outpacing knowledge of these games' effects, raising calls for evidence of benefits and challenges. Studies suggest that students and teachers like games, but the payoff of the investment in terms of increased motivation and achievement remains unclear. Objectives: This study investigates the pure effect of a marketing simulation game on motivation, perceived learning and achievement, above and beyond regular student‐active instruction. Methods: We applied a randomized, controlled experiment in a marketing course in upper‐secondary schools (Nclasses = 22; Nstudents = 433) comparing a collaborative–competitive marketing simulation game with regular, case‐based, student‐active instruction on three groups of outcome measures: motivation, perceived ability, and achievement. Additionally, students and teachers provided quantitative and qualitative feedback on game experiences. Results and Conclusions: We showcase the importance of a robust study design with valid compound instruments. Moreover, investigations of the game implementation and experiences reveal insights about intervention timing, differential negative consequences by gender and need for reflection opportunities. We find no clear evidence of positive or negative effects of the game, despite students' and teachers' satisfaction. Implications: Beyond the effect evaluation, we offer recommendations to researchers and developers of educational games about scaffolding, timing and teacher competence building. Lay Description: What is already known about this topic: Some curricula contains many terms and complex knowledge links.Simulation games are a popular remedy for these challenges.Prior studies have relied on users' satisfaction with the game and unrealistic comparisons. What this paper adds: This experiment compares game usage and regular student‐active instruction.They use various measures of satisfaction, motivation, perceived learning and achievement.The game has no effect on main outcomes. Implications for practice and/or policy: Game implementation requires digitally acquainted and trained teachers.Uncritical game design and use may motivate competitive boys over collaborative girls. [ABSTRACT FROM AUTHOR]

Background: The articulatory accuracy of patients with dysarthria is one of the most affected speech dimensions with a high impact on speech intelligibility. Behavioural treatments of articulation can either involve direct or indirect approaches. The latter have been thoroughly investigated and are generally appreciated for their almost immediate effects on articulation and intelligibility. The number of studies on (short‐term) direct articulation therapy is limited. Aims: To investigate the effects of short‐term, boost articulation therapy (BArT) on speech intelligibility in patients with chronic or progressive dysarthria and the effect of severity of dysarthria on the outcome. Methods & Procedures: The study consists of a two‐group pre‐/post‐test design to assess speech intelligibility at phoneme and sentence level and during spontaneous speech, automatic speech and reading a phonetically balanced text. A total of 17 subjects with mild to severe dysarthria participated in the study and were randomly assigned to either a patient‐tailored, intensive articulatory drill programme or an intensive minimal pair training. Both training programmes were based on the principles of motor learning. Each training programme consisted of five sessions of 45 min completed within one week. Outcomes & Results: Following treatment, a statistically significant increase of mean group intelligibility was shown at phoneme and sentence level, and in automatic sequences. This was supported by an acoustic analysis that revealed a reduction in formant centralization ratio. Within specific groups of severity, large and moderate positive effect sizes with Cohen's d were demonstrated. Conclusions & Implications: BArT successfully improves speech intelligibility in patients with chronic or progressive dysarthria at different levels of the impairment. What this paper addsWhat is already known on the subjectBehavioural treatment of articulation in patients with dysarthria mainly involves indirect strategies, which have shown positive effects on speech intelligibility. However, there is limited evidence on the short‐term effects of direct articulation therapy at the segmental level of speech. This study investigates the effectiveness of BArT on speech intelligibility in patients with chronic or progressive dysarthria at all severity levels.What this paper adds to existing knowledgeThe intensive and direct articulatory therapy programmes developed and applied in this study intend to reduce the impairment instead of compensating it. This approach results in a significant improvement of speech intelligibility at different dysarthria severity levels in a short period of time while contributing to exploit and develop all available residual motor skills in persons with dysarthria.What are the potential or actual clinical implications of this work?The improvements in intelligibility demonstrate the effectiveness of a BArT at the segmental level of speech. This makes it to be considered a suitable approach in the treatment of patients with chronic or progressive dysarthria. [ABSTRACT FROM AUTHOR]

Background: A total of 68% of pre‐school children with cleft palate have speech problems requiring speech therapy. There is a lack of access to regular targeted therapy. Parent training leads to positive outcomes in early communication skills in cleft palate and non‐cleft speech disorders. Connected health has been used to address inadequate access to therapy, providing intervention to those who would not otherwise receive therapy. Aims: To evaluate the speech, activity and participation outcomes of Parent Led, Therapist Supervised, Articulation Therapy (PLAT) compared with routine speech therapy intervention in parent–child dyads. Methods & Procedures: A total of 44 children, aged 2.9–7.5 years, were included in a two‐centre, two‐phase randomized controlled trial. Informed consent and assent were obtained. Participants and speech and language therapists (SLTs) were unblinded to the groups. Parents, in the parent‐trained group (n = 23), attended 2 days' training, received a detailed speech therapy programme, and undertook intervention over 12 weeks supported by the cleft specialist SLT using FaceTime and one face‐to‐face session. In the control arm (n = 21), parent–child dyads received six therapy sessions over 12 weeks with a research SLT, comparable with usual care. Speech recordings were undertaken pre‐ and post‐intervention. Percent consonant correct (PCC) was analysed by external SLTs blinded to the time and group. Activity and participation were measured using the Intelligibility in Context Scale (ICS) and Focus on Outcomes for Children Under Six (FOCUS) questionnaire. Outcomes & Results: There was no evidence of an interaction between Time and Group or an overall statistical difference between groups for PCC scores. There was a statistically significant difference over time for both groups (words: p < 0.002; confidence interval (CI) = 9.38–16.27; d = 0.57; sentences: p < 0.002; CI = 16.04–25.97; d = 0.23). Effect sizes were medium for words and small for sentences. For intelligibility and participation, there was no evidence of an interaction between Time and Group or an overall statistical difference between groups. A statistically significant difference over time was found for intelligibility (F = 29.97, d.f. = 1, 42, p < 0.001, 95 % CI = 1.45–3.15 d = 0.46) and for participation (F = 14.19, d.f. = 1, 41, p < 0.001 95% CI = 7.63–25.03; d = 0.36) with FOCUS results indicating clinically meaningful (parent‐led group) and significant (control group) change in participation. Conclusions & Implications: PLAT can be as effective as routine care in changing speech, activity and participation outcomes for children with cleft palate, when supported by a specialist cleft SLT using connected health. What this paper addsWhat is already known on this subjectOver 50% of children with cleft palate require speech therapy. However, there is a lack of timely, accessible speech therapy services in the UK and Ireland. Previous studies have shown that parents can deliver therapy effectively, and that connected health can support the delivery of speech therapy. This study aims to provide evidence that parent‐led therapy with the supervision of a specialist cleft therapist using FaceTime is effective.What this paper adds to existing knowledgeThis randomized controlled trial indicates that parents can be trained to deliver therapy for children with cleft palate speech disorders, under the supervision of an SLT. This approach results in improved speech, activity and participation outcomes similar to routine care.What are the potential or actual clinical implications of this work?This study indicates that both parent‐led articulation therapy and routine care showed meaningful gains in speech, activity and participation, and that parent‐led articulation therapy when supported by a cleft SLT using connected health could be an additional service delivery model for children with cleft palate speech disorders. [ABSTRACT FROM AUTHOR]

Given the widespread use of touch screen devices, the effect of the users' fingers on information processing and learning is of growing interest. The present study drew on cognitive load theory and embodied cognition perspectives to investigate the effects of pointing and tracing gestures on the surface of a multimedia learning instruction. Learning performance, cognitive load and visual attention were examined in a one‐factorial experimental design with the between‐subject factor pointing and tracing gestures. The pointing and tracing group were instructed to use their fingers during the learning phase to make connections between corresponding text and picture information, whereas the control group was instructed not to use their hands for learning. The results showed a beneficial effect of pointing and tracing gestures on learning performance, a significant shift in visual attention and deeper processing of information by the pointing and tracing group, but no effect on subjective ratings of cognitive load. Implications for future research and practice are discussed. Lay Description: What is currently known about the subject matter? Pointing and tracing gestures enhance learning with multimediaThe effect is true for paper based and digital learning instructionsLess is known about the cause of this effect with regard to complex learningDifferent theoretical explanations are currently discussed What our paper adds to this A detailed analysis of the effect using eye‐tracking and touch screen dataEvidence that the effect of pointing and tracing is mediated by eye‐movementsRelevant information concerning the discussion about theoretical explanations The implications of study findings for practitioners Pointing and tracing gestures can guide the learners' visual focus of attentionPointing and tracing gestures can increase the learners' visual attentionPointing and tracing gestures foster information processing when learning with multimediaLearners can or even should use pointing and tracing gestures to support learning [ABSTRACT FROM AUTHOR]

Background: Very young children from lower socioeconomic status (SES) backgrounds often show poorer language development. Whilst there have been attempts to provide early intervention programmes, these sometimes miss the most disadvantaged groups. Aims: This report presents preliminary feasibility and effectiveness data for a novel language intervention designed for parents of toddlers in the United Kingdom. Methods and Procedures: In total, 43 UK families of 2–4‐year‐olds were recruited to the study, half of whom completed an 8‐week course (Tots Talking) focussed on parent interaction, and half of whom acted as wait‐list controls. Results and Outcomes: Results suggest that such programmes are feasible for families with 86% staying in the intervention. In addition, greater changes in underlying communication skills such as joint attention and gesture were evident compared to wait‐list controls. Conclusions and Implications: We conclude that pre‐verbal skills may be more important to measure as initial outcomes than language or vocabulary change in this population. What This Paper Adds: What is already known on the subject: Children from lower socioeconomic status (SES) backgrounds are at higher risk of communication difficulties and there is a need for community intervention programmes for very young children. What this study adds: This study suggests that such programmes can be feasible and effective, but that very early/basic communicative skills (such as joint attention) may be boosted first rather than language or vocabulary. What are the clinical implications of this work?: Children's centres and other community services could feasibly run short parent facing courses emphasising contingent communication in low SES families and other diverse groups. These may be more successful run with younger preschoolers. Joint attention may be a better focus of intervention before expecting vocabulary or language change. Community health professionals may find this information useful in referring and supporting families in need. [ABSTRACT FROM AUTHOR]

Supportive counseling and facilitated referrals to support organizations have shown positive effects on mental health and coping with domestic and family violence. However, the reasons why and how such effects are significant remain unknown. The current paper used data from a randomized controlled trial of a psychosocial intervention implemented in Nepal among 140 abused pregnant women. The hypothesized mediating effects of self‐efficacy and social support on mental health and quality of life of abused pregnant women were tested using serial mediation analyses. Significance of parameter estimates and bias‐corrected 95% confidence intervals (CIs) for the indirect effects were generated using bootstrapping. The postintervention changes in self‐efficacy and social support were found to have significant mediating effects on the relationship between the intervention and changes in both mental health and quality of life of participants post intervention. The positive effects on outcomes were seen at follow‐up as well, though to a lesser extent. Further interventions should focus on enhancing abused women's self‐efficacy and social support to ensure their positive mental health and better lives. [ABSTRACT FROM AUTHOR]

Aim To review randomized controlled trials to assess efficacy of a prize-based contingency management procedure in reducing substance use (where a drug-free breath or urine sample provides a chance of winning a prize). Methods A meta-analysis was conducted on papers published from January 2000 to February 2013 to determine the effect size of studies comparing prize-based contingency management to a treatment-as-usual control condition (k = 19 studies). Parallel analyses evaluated the efficacy of both short- (k = nine studies) and long-term outcomes (k = six studies) of prize-based contingency management. Results The average end-of-treatment effect size (Cohen’s d) was 0.46 [95% confidence interval (CI) = 0.37, 0.54]. This effect size decreased at the short-term (≤3-month) post-intervention follow-up to 0.33 (95% CI = 0.12, 0.54) and at the 6-month follow-up time-point there was no detectable effect [d = −0.09 (95% CI = −0.28, 0.10)]. Conclusion Adding prize-based contingency management to behavioral support for substance use disorders can increase short-term abstinence, but the effect does not appear to persist to 6 months. [ABSTRACT FROM AUTHOR]

Objective: The beneficial effects of antiseptics in the treatment of periodontitis are still controversial. The goal of this randomized split-mouth study was to evaluate the clinical and microbiologic results of a unique subgingival irrigation of 10% povidone-iodine in addition to a full-mouth scaling and root planing for the treatment of chronic periodontitis. Method and Materials: Twenty patients with chronic periodontitis took part in this investigation. In each patient, four initially untreated pockets > 4 mm were randomly selected for one subgingival irrigation. After a one-session full-mouth treatment with scaling and root planing (SRP), two pockets of a split mouth received one unique irrigation with 10 mL 0.9% NaCl solution (control group, CG). Two pockets on the other side received 10 mL of povidone-iodine 10% (test group, PIG). Full-mouth plaque score (FMPS), full-mouth bleeding score (FMBS), Plaque Index (PI), Gingival Index (GI), probing pocket depth (PPD), and clinical attachment level (CAL) parameters were assessed at baseline and after 1, 3, and 6 months (M). Bacterial samplings with sterile paper points were taken at M0 and after M1, M3, and M6. These samplings were separately cultured under aerobic and anaerobic conditions before CFU evaluation. Results: Pl, GI, PPD, and CAL were significantly improved in both groups after 6 months. The major difference was seen between M0 and M3 (P<.001). No significant differences were seen between the groups, except for deep pockets (> 6 mm) where a statistical difference was observed in favor of PIG after 6 months; in these subgroups the mean probing reduction was 2.68 ± 0.37 mm for CG versus 3.93 ±0.23 mm in PIG (P<.001). No significant differences were seen between CG and PIG regarding the microbiologic results after 6 months. Conclusion: One single irrigation of 10% povidone-iodine associated with full-mouth SRP would bring a small additional benefit in deep pockets. More studies are needed to yield additional results. [ABSTRACT FROM AUTHOR]

While video games can be helpful in personal development, participating in certain gaming activities may lead to negative effects such as video game addiction. The overuse of computer games, which can lead to reduced quality of life and affect a person's practical skills. Around 3% of adolescents suffer from Internet Gaming Disorder (IGD), there is currently no universally accepted psychometric method. The AICA-S scale was applied to results from 3,901 respondents aged between 11 and 19. During the 2017/2018 school year, a battery of questionnaires in "pen and paper" form was administered to students at primary schools and secondary schools. The respondents were selected from all the regions of the Czech Republic through a random stratified selection to ensure that the respondents were an accurate representation of students across the Czech Republic. The results were obtained using statistical methods such as ANOVA, chi-square tests and t-tests. These results affirm the psychometric quality of AICA-S and note the prevalence of IGD among Czech adolescents. Based on our results, 0.8% of our respondents fulfilled the criteria for an IGD. [ABSTRACT FROM AUTHOR]

Abstract: Aim: To assess the effectiveness of non‐pharmacological interventions for pregnant women with symptoms of mild to moderate anxiety. Background: Many pregnant women experience mild to moderate symptoms of anxiety and could benefit from additional support. Non‐pharmacological interventions have been suggested for use during pregnancy. Design: A systematic review of randomized controlled trials. Data sources: Randomized controlled trials published since 1990, identified from electronic databases: Medline; CINAHL; Maternity and Infant Care; PsycINFO; Cochrane Database of Systematic Reviews; CENTRAL; EMBASE; Centre for Reviews and Dissemination; Social Sciences Citation Index; ASSIA; HTA Library; Joanna Briggs Institute Evidence‐Based Practice database; Allied and Complementary Medicine. Review methods: Conducted according to the Centre for Reviews and Dissemination procedure. Papers were screened (N = 5,222), assessed for eligibility (N = 57) and selected for inclusion (N = 25). The Cochrane Collaboration's tool for assessing risk of bias was used. Papers were assessed for clinical and statistical heterogeneity and considered for meta‐analysis. Descriptive analysis of the data was conducted. Results: Psychological, mind‐body, educational and supportive interventions were delivered individually and to groups of pregnant women over single or multiple sessions. The State‐Trait Anxiety Inventory was the most commonly used anxiety measure. In 60% of studies there were fewer than 40 participants. Meta‐analysis of three studies indicated no observed beneficial effect in the reduction of anxiety. Conclusion: There was insufficient evidence from which to draw overall conclusions regarding the benefit of interventions. Results were predominantly based on small samples. Many papers provided an inadequate description of methods which prevented a full assessment of methodological quality. [ABSTRACT FROM AUTHOR]

As immersive virtual reality (IVR) systems proliferate in classrooms, it is important to understand how they affect learning outcomes and the underlying affective and cognitive processes that may cause these outcomes. Proponents argue that IVR could improve learning by increasing positive affective and cognitive processing, thereby supporting improved performance on tests of learning outcome, whereas opponents of IVR contend that it could hurt learning by increasing distraction, thereby disrupting cognitive learning processes and leading to poorer learning outcomes. In a media comparison study, students viewed a biology lesson either as an interactive animated journey in IVR or as a slideshow on a desktop monitor. Those who viewed the IVR lesson performed significantly worse on transfer tests, reported higher emotional arousal, reported more extraneous cognitive load and showed less engagement based on EEG measures than those who viewed the slideshow lesson, with or without practice questions added to the lessons. Mediational analyses showed that the lower retention scores for the IVR lesson were related to an increase in self‐reported extraneous cognitive load and emotional arousal. These results support the notion that immersive environments create high affective and cognitive distraction, which leads to poorer learning outcomes than desktop environments. Lay Description: What is already known about the topic: IVR is gaining popularity in classrooms, and it is important to understand its effects on learning.Some theories suggest IVR could help learning because it may increase motivation.Other theories suggest IVR could hurt learning because it causes distraction. What this paper adds: The biology lesson displayed in IVR led to less learning than a PowerPoint lesson.Viewing the IVR lesson caused higher emotional arousal than viewing the PowerPoint lesson.The IVR lesson led to more distraction based on self‐report and EEG measures than the PowerPoint lesson.These results suggest that IVR creates high emotional and cognitive distraction, which leads to less learning. Implications for practice: Using IVR to replace traditional classroom lessons may not yet be useful.However, because students report enjoying IVR, it may be useful to use in addition to conventional lessons.Future research should determine how specific factors of the technology and the learners affect learning outcomes. [ABSTRACT FROM AUTHOR]

Background: ARCHER 1050, an ongoing, randomized, open-label, phase III trial of dacomitinib versus gefitinib in newly diagnosed patients with advanced non-small-cell lung cancer (NSCLC) and an EGFR-activating mutation, reported significant improvement in overall survival (OS) with dacomitinib. Objective: This paper reports an updated OS analysis of ARCHER 1050 after an extended follow-up. Patients and methods: In this multinational, multicenter trial, adults (aged ≥ 18 years or ≥ 20 years in Japan and Korea) with newly diagnosed NSCLC and EGFR mutation (exon 19 deletion or exon 21 L858R substitution), and no history of central nervous system metastases, were randomized 1:1 to receive dacomitinib 45 mg/day (n = 227) or gefitinib 250 mg/day (n = 225). Randomization was stratified by race and EGFR mutation type. An ad hoc updated analysis of OS was conducted at the protocol-defined cut-off of 48 months from first dosing of the last enrolled patient (13 May 2019). Results: After a median follow-up of 47.9 months, 133 (58.6%) patients had died in the dacomitinib arm and 152 (67.6%) in the gefitinib arm. The hazard ratio (HR) for OS was 0.748 (95% CI 0.591–0.947; two-sided P = 0.0155); median OS was 34.1 months with dacomitinib versus 27.0 months with gefitinib. The HR for OS in patients with dose reduction(s) in the dacomitinib arm (n = 154) compared with all patients in the gefitinib arm was 0.554 (95% CI 0.420–0.730); median OS was 42.5 months for patients with dose reduction(s) in the dacomitinib arm. The most common adverse events were diarrhea (87.7%), paronychia (61.7%), dermatitis acneiform (49.3%), and stomatitis (43.6%) with dacomitinib, and diarrhea (55.8%) and alanine aminotransferase increased (40.2%) with gefitinib. Conclusions: The OS benefit from first-line treatment with dacomitinib versus gefitinib was maintained after extended follow-up in patients with advanced NSCLC with EGFR-activating mutations. ClinicalTrials.gov: NCT01774721 (registered 24 January 2013). [ABSTRACT FROM AUTHOR]

Background: Non-adherence to medications is prevalent across all medical conditions that include ambulatory pharmacotherapy and is thus a major barrier to achieving the benefits of otherwise effective medicines. Objective: The objective of this systematic review was to identify and to compare the efficacy of strategies and components thereof that improve implementation of the prescribed drug dosing regimen and maintain long-term persistence, based on quantitative evaluation of effect sizes across the aggregated trials. Data sources: MEDLINE, EMBASE, CINAHL, the Cochrane Library, and PsycINFO were systematically searched for randomized controlled trials that tested the efficacy of adherence-enhancing strategies with self-administered medications. The searches were limited to papers in the English language and were included from database inception to 31 December 2011. Study selection: Our review included randomized controlled trials in which adherence was assessed by electronically compiled drug dosing histories. Five thousand four hundred studies were screened. Eligibility assessment was performed independently by two reviewers. A structured data collection sheet was developed to extract data from each study. Study appraisal and synthesis methods: The adherence-enhancing components were classified in eight categories. Quality of the papers was assessed using the criteria of the Cochrane Handbook for Systematic Reviews of Interventions guidelines to assess potential bias. A combined adherence outcome was derived from the different adherence variables available in the studies by extracting from each paper the available adherence summary variables in a pre-defined order (correct dosing, taking adherence, timing adherence, percentage of adherent patients). To study the association between the adherence-enhancing components and their effect on adherence, a linear meta-regression model, based on mean adherence point estimates, and a meta-analysis were conducted. Results: Seventy-nine clinical trials published between 1995 and December 2011 were included in the review. Patients randomized to an intervention group had an average combined adherence outcome of 74.3 %, which was 14.1 % higher than in patients randomized to the control group (60.2 %). The linear meta-regression analysis with stepwise variable selection estimated an 8.8 % increase in adherence when the intervention included feedback to the patients of their recent dosing history (EM-feedback) ( p < 0.01) and a 5.0 % increase in adherence when the intervention included a cognitive-educational component ( p = 0.02). In addition, the effect of interventions on adherence decreased by 1.1 % each month. Sensitivity analysis by selecting only high-quality papers confirmed the robustness of the model. The random effects model in the meta-analysis, conducted on 48 studies, confirmed the above findings and showed that the improvement in adherence was 19.8 % (95 % CI 10.7-28.9 %) among patients receiving EM-feedback, almost double the improvement in adherence for studies that did not include this type of feedback [10.3 % (95 % CI 7.5-13.1 %)] ( p < 0.01). The improvement in adherence was 16.1 % (95 % CI 10.7-21.6 %) in studies that tested cognitive-educational components versus 10.1 % (95 % CI 6.6-13.6 %) in studies that did not include this type of intervention ( p = 0.04). Among 57 studies measuring clinical outcomes, only 8 reported a significant improvement in clinical outcome. Limitations: Despite a common measurement, the meta-analysis was limited by the heterogeneity of the pooled data and the different measures of medication adherence. The funnel plot showed a possible publication bias in studies with high variability of the intervention effect. Conclusions: Notwithstanding the statistical heterogeneity among the studies identified, and potential publication bias, the evidence from our meta-analysis suggests that EM-feedback and cognitive-educational interventions are potentially effective approaches to enhance patient adherence to medications. The limitations of this research highlight the urgent need to define guidelines and study characteristics for research protocols that can guide researchers in designing studies to assess the effects of adherence-enhancing interventions. [ABSTRACT FROM AUTHOR]

Some estrogen metabolites are associated with increased breast cancer risk, while others are protective. Research efforts have focused on modifiable factors, including bioactive compounds found in food or supplements, promoting estrogen profiles with anti-cancer properties. EstroSense® is a nutraceutical product with bioactive compounds, including Indole-3-carbinol and green-tea catechins, which may favourably affect estrogen profiles. This study was conducted to determine if EstroSense use, compared to placebo, promotes a higher urinary 2-hydroxyestrone:16α-hydroxyestrone ratio (2-OHE1:16α-OHE1), a biomarker associated with a lowered risk of breast cancer. A total of 148 premenopausal women were recruited from British Columbia, Canada to participate in a randomized, double-blind, cross-over, multicentre, placebo-controlled study in which women were randomized to a treatment sequence that consisted of either EstroSense®, followed by placebo or vice-versa. The women were instructed to consume three capsules per day of EstroSense® or the placebo for three menstrual cycles (∼12 weeks). The primary outcome was the measurement of 2-OHE1:16α-OHE1 in casual samples at baseline and after each treatment phase. After 12 weeks of intervention, the mean (95% CI) urinary 2-OHE1:16α-OHE1 was 4.55 (2.69, 6.42) (p<0.001) higher following EstroSense than placebo adjusted for baseline values. EstroSense use led to markedly higher urinary 2-OHE1:16α-OHE1 than the placebo, a biomarker associated with a lower risk of breast cancer. http://clinicaltrials.gov (NCT02385916). [ABSTRACT FROM AUTHOR]

INTRODUCTION Mobile interventions enable personalized behavioral support that could improve smoking cessation (SC) in smokers ready to quit. Scalable interventions, including unmotivated smokers, are needed. We evaluated the effect of personalized behavioral support through mobile interventions plus nicotine replacement therapy sampling (NRT-S) on SC in Hong Kong community smokers. METHODS A total of 664 adult daily cigarette smokers (74.4% male, 51.7% not ready to quit in 30 days) were proactively recruited from smoking hotspots and individually randomized (1:1) to the intervention and control groups (each, n=332). Both groups received brief advice and active referral to SC services. The intervention group received 1-week NRT-S at baseline and 12-week personalized behavioral support through SC advisor-delivered Instant Messaging (IM) and a fully automated chatbot. The control group received regular text messages regarding general health at a similar frequency. Primary outcomes were carbon monoxide-validated smoking abstinence at 6 and 12 months post-treatment initiation. Secondary outcomes included self-reported 7-day point-prevalence and 24-week continuous abstinence, quit attempts, smoking reduction, and SC service use at 6 and 12 months. RESULTS By intention-to-treat, the intervention group did not significantly increase validated abstinence at 6 months (3.9% vs 3.0%, OR=1.31; 95% CI: 0.57-3.04) and 12 months (5.4% vs 4.5%, OR=1.21; 95% CI: 0.60-2.45), as were self-reported 7-day point-prevalence abstinence, smoking reduction, and SC service use at 6 and 12 months. More participants in the intervention than control group made a quit attempt by 6 months (47.0% vs 38.0%, OR=1.45; 95% CI: 1.06-1.97). Intervention engagement rates were low, but engagement in IM alone or combined with chatbot showed higher abstinence at 6 months (adjusted odds ratios, AORs=4.71 and 8.95, both p<0.05). CONCLUSIONS Personalized behavioral support through mobile interventions plus NRT-S did not significantly improve abstinence in community smokers compared to text only messaging. The suboptimal intervention engagement needs to be addressed in future studies. [ABSTRACT FROM AUTHOR]

Objective: Arginine-containing toothpastes are a promising new treatment for dentin hypersensitivity (DH), which afflicts a considerable number of patients. However, there have to date been only individual studies. We aim to present an overview of the clinical evidence in order to determine trends and establish firmer conclusions regarding the use of arginine-containing toothpastes for management of DH. Method and Materials: A protocol was developed based on the Cochrane Handbook for Systematic Reviews of Interventions (version 5.1.0), including: search strategy, selection criteria, data extraction, and risk of bias assessment. We searched electronic databases (up to October 2012) without language limitation, and reference lists of relevant papers for randomized controlled trials that assessed the efficacy of arginine-containing toothpastes for DH treatment. Data extraction and domain-based risk of bias assessment were independently performed by two reviewers. The meta-analysis was performed in STATA (version 12.0). The GRADE analysis was conducted in GRADE profiler (version 3.6). Results: Fourteen randomized controlled studies with different risk of bias were included in the meta-analysis, all evaluated by tactile and air blast assessment. The mean differences and standard deviations for each treatment group were pooled for analysis using a random-effect model. We found that arginine-containing toothpastes had better overall effects in comparison with placebo toothpastes (P < .05), potassium salt-containing toothpastes (P < .05), and strontium-containing toothpastes (P < .05). The GRADE analysis showed that quality of the evidence was moderate when arginine-containing toothpastes were compared to placebo and potassium salt-containing toothpastes, and quality of the evidence was low with comparison to strontium-containing toothpastes. Conclusion: Current available clinical evidence suggests that arginine-containing toothpastes are associated with the reduction of DH compared to both placebo and positive control toothpastes. However, there are limitations to the current studies, and more well-designed trials are needed to confirm the efficacy. [ABSTRACT FROM AUTHOR]

This paper examined whether a two-year change in fitness, body mass index (BMI) or the additive effect of change in fitness and BMI were associated with change in cardiometabolic risk factors among youth. Cardiometabolic risk factors, BMI group (normal weight, overweight or obese) were obtained from participants at the start of 6th grade and end of 8th grade. Shuttle run laps were assessed and categorized in quintiles at both time points. Regression models were used to examine whether changes in obesity, fitness or the additive effect of change in BMI and fitness were associated with change in risk factors. There was strong evidence (p < .001) that change in BMI was associated with change in cardiometabolic risk factors. There was weaker evidence of a fitness effect, with some evidence that change in fitness was associated with change in total cholesterol, HDL-C, LDL-C and clustered risk score among boys, as well as HDL-C among girls. Male HDL-C was the only model for which there was some evidence of a BMI, fitness and additive BMI"fitness effect. Changing body mass is central to the reduction of youth cardiometabolic risk. Fitness effects were negligible once change in body mass had been taken into account [ABSTRACT FROM AUTHOR]

Background Professional community health workers (CHWs) can help achieve universal health coverage, although evidence gaps remain on how to optimise CHW service delivery. We conducted an unblinded, parallel, cluster randomised trial in rural Mali to determine whether proactive CHW delivery reduced mortality and improved access to health care among children under five years, compared to passive delivery. Here we report the secondary access endpoints. Methods Beginning from 26-28 February 2017, 137 village-clusters were offered care by CHWs embedded in communities who were trained, paid, supervised, and integrated into a reinforced public-sector health system that did not charge user fees. Clusters were randomised (stratified on primary health centre catchment and distance) to care during CHWs during door-to-door home visits (intervention) or based at a fixed village site (control). We measured outcomes at baseline, 12-, 24-, and 36-month time points with surveys administered to all resident women aged 15-49 years. We used logistic regression with cluster-level random effects to estimate intention-to-treat and per-protocol effects over time on prompt 24-hour treatment within the health sector. Results Follow-up surveys between February 2018 and April 2020 generated 20 105 child-year observations. Across arms, prompt health sector treatment more than doubled compared to baseline. At 12 months, children in intervention clusters had 22% higher odds of receiving prompt health sector treatment than those in control (cluster-specific adjusted odds ratio (aOR) = 1.22; 95% confidence interval (CI) = 1.06, 1.41, P = 0.005), or 4.7 percentage points higher (adjusted risk difference (aRD) = 0.047; 95% CI = 0.014, 0.080). We found no evidence of an effect at 24 or 36 months. Conclusions CHW-led health system redesign likely drove the 2-fold increase in rapid child access to care. In this context, proactive home visits further improved early access during the first year but waned afterwards. [ABSTRACT FROM AUTHOR]

Background The maternal and child health (MCH) handbook is promoted as a tool for strengthening continuum of care. We assessed the effect of a MCH handbook intervention package on continuum of maternal and child health care and health outcomes for mother and child. Methods We conducted an open-label, parallel two-arm cluster randomized controlled trial in Angola. We randomly assigned municipalities in Benguela province through block randomization to a group using a package of enhanced maternity care service (which included the MCH handbook distribution and its supplementary intervention) and another using usual care (two stand-alone home-based records). We included women who were pregnant at the beginning of the trial period and attended a public health care facility for maternity care services. Neither health care providers, study participants nor data assessors were masked, but the statistician was. The primary outcome was a measure of service utilization assessed via achievement of maternal behavior-based continuum of care at three months postpartum. We conducted an intention-to-treat analysis in women with available data. Results We randomized 10 municipalities to either the intervention (five clusters) or control (five clusters) group. Of the 11530 women approached between June 8, 2019, and September 30, 2020, 11006 were recruited and 9039 included in the final analysis (82%; 3774 in the intervention group and 5265 in the control group). The odds for achievement of maternal behavior-based continuum of care in the intervention group was not significantly different from that in the control group (adjusted odds ratio (aOR)=1.18, 95% confidence interval (CI)=0.46-2.93) at three months postpartum. However, the odds of initiating antenatal care clinic use were significantly higher in the intervention group (odds ratio (OR)=5.16, 95% CI=2.50-10.67). No harms associated with the intervention were reported. Conclusions Distribution of the MCH handbook and its supplementary interventions promoted initiation of antenatal care service use, but did not increase service utilization sufficiently enough for attainment of study defined maternal behavior-based continuum of care. [ABSTRACT FROM AUTHOR]