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Purpose: This study aimed to determine the validity and reliability of the electronic Compassion Competence Scale (e-CCS). Methods: A cross-sectional, randomized, two-period crossover design was used. Nursing students from four South Korean universities were surveyed between June 2017 and April 2018. The participants were randomly assigned to one of three groups-paper/paper, electronic/electronic, and paper/electronic or electronic/paper-and a test-retest procedure was implemented. The reliability and validity of the e-CCS were evaluated using linear weighted kappa coefficients and intraclass correlation coefficients (ICCs). Internal consistency reliability was verified using linear weighted kappa coefficients and ICCs. Pearson's correlation coefficients between the initial test and retest scores were all statistically significant. Results: The newly developed e-CCS was found to have good reliability and validity. We suggest that future research should increase sample heterogeneity by recruiting diverse age groups, nurses working in different nursing fields, and students from multiple colleges. Conclusion: This electronic instrument will help determine the differences in the level of compassion competence and devise interventions to improve compassion competence in nurses and nursing students. Further studies on enhancing compassion competence among nurses and nursing students may rely on the use of this electronic format. [ABSTRACT FROM AUTHOR]

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]

For the past 25 years, I have led multiple group-randomized trials, each focused on a specific underserved population of youth and each one evaluated health effects of complex interventions designed to prevent high-risk behaviors. I share my reflections on issues of intervention and research design, as well as how research results fostered my evolution toward addressing fundamental social determinants of health and well-being. Reflections related to intervention design emphasize the importance of careful consideration of theory of causes "and" theory of change, theoretical comprehensiveness versus fundamental determinants of population health, how high to reach, and health in all policies. Flowing from these intervention design issues are reflections on implications for research design, including the importance of matching the unit of intervention to the unit of assignment, the emerging field of public health law research, and consideration of design options and design elements beyond and in combination with random assignment. [Paper presented at the Stockholm Conference on Behavioral and Social Intervention Research, 11-12 May, 2017.]

Aim: This study aimed to evaluate the effects of uncoated paper on skin moisture, pressure injury risk and pressure injury incidence in neurological intensive care unit patients. Methods: A randomized controlled design was used. The experimental group (n = 68) received usual care (repositioning every 2 h and use of an air mattress) and application of uncoated paper on the sacral area for 5 days, whereas the control group (n = 67) received only usual care. A repeated measures analysis of variance was used to determine changes in the skin moisture and risk of pressure injury between the groups. A chi‐squared test was used to determine the change in the incidence of pressure injuries for sacral area. Data were collected from 20 October 2017 to 6 March 2018. Results: There were statistically significant differences in the skin moisture and risk of pressure injuries between the experimental and control groups. However, a significant difference was not observed in the incidence of pressure injuries between the groups. Conclusion: The use of uncoated paper may be a valid nursing intervention for the prevention of pressure injuries in neurological intensive care unit patients. SUMMARY STATEMENT: What is already known about this topic? The neurological intensive care unit patients with motor deficits, loss or deterioration of sensory function and decreased consciousness have high risk of pressure injuries.Although various guidelines consider excessive skin moisture as an important cause of pressure injuries, few targeted interventions exist to manage excessive skin moisture. What this paper adds? The uncoated paper application was effective in reducing skin moisture in neurologic intensive care unit patients.In addition, application of uncoated paper application has an effect on risk of pressure injury in neurologic intensive care unit patients. The implications of this paper: The use of uncoated paper may be a valid nursing intervention for the prevention of pressure injuries in neurological intensive care unit patients.Nurses should recognize that pressure injuries are potentially preventable adverse events and use various preventive interventions including skin moisture management. [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]

Purpose: This study compared a tablet PC questionnaire with a paper method for reliability and patient preferences in the acquisition of patient-reported outcomes (PROs) for patients treated with radiotherapy. By comparing the two modes of PRO administration, we aimed to evaluate the adequacy of using tablet PC questionnaires in future clinical use.Methods: Patients were randomized in a crossover study design using two different methods for PRO entry. A group of 89 patients answered a paper questionnaire followed by the tablet PC version, whereas 89 patients in another group completed the tablet PC questionnaire followed by the paper version. Surveys were performed four times per patient throughout the course of the radiotherapy. The Korean versions of the M.D. Anderson Symptom Inventory (MDASI-K) and the Brief Fatigue Inventory (BFI-K) were used. The primary endpoint of our current study was an assessment of patient preference for the survey method. The proportions of patients preferring each mode of questionnaire were evaluated.Results: The proportion of patients who preferred the tablet PC version, paper form, or who had no preference was 52.2, 22.1, and 25.7 %, respectively. More than half of the patients preferred the tablet PC to the paper version in all four surveys. Age, gender, educational status, prior experience of using a tablet PC, and the order of paper to tablet PC administration did not impact patient preferences. Inter-class correlation coefficients (ICCs) between the modes were 0.92 for MDASI-K and 0.94 for BFI-K and ranged from 0.91 to 0.96 on both instruments during the four surveys.Conclusions: A tablet PC-based PRO is an acceptable and reliable method compared with paper-based data collection for Korean patients receiving radiotherapy. [ABSTRACT FROM AUTHOR]

Background: In 2019, a randomized controlled trial (RCT) authored by Dr. Ismail was retracted due to concerns about data integrity. Since there are no policies in place to investigate other publications of authors of retracted studies, we investigated Dr. Ismail's other trials.Methods: We searched for RCTs authored by Dr. Ismail. We made pairwise comparisons of values in baseline and outcome tables between trials. We assessed whether the distributions of baseline characteristics were compatible with properly conducted randomization, using Monte Carlo simulations and the Kolmogorov-Smirnov test. We read the publications carefully for unusual features.Results: Dr. Ismail was author in eight published and one unpublished trial. In three of his first author studies we found multiple identical values in the baseline and/or outcome tables from different trials. At least some of the trials were unlikely to have followed a proper randomization process. There were a number of other unusual features in the papers we reviewed.Conclusions: It is probable that other trials published by Dr. Ismail contain questionable data. We call for a thorough investigation of the original trial data and related official documents. Our exercise suggests that the practice to assess research integrity should include all publications of authors with retracted fabricated articles. [ABSTRACT FROM AUTHOR]

The article discusses the approaches for gluteal tendinopathy which includes education plus exercise and corticosteroid injection.

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

Randomised Control Trials (RCT) serve as the gold standard in research design, offering valuable insights into evaluating the impact of nursing interventions on patient health outcomes. This paper explores the methodological considerations and challenges inherent in designing and conducting RCTs within the nursing context. The inclusion criteria involved a thorough search across reputable databases, including CEINAHL, EBSCO, Scopus, Google Scholar, and Cochrane Library, spanning any period due to the scarcity of relevant material. Articles were selected based on their alignment with key considerations such as randomisation, blinding, sample size calculations, outcome measures, and ethical aspects. Data extraction involved findings related to methodological considerations and challenges faced by nurse researchers in RCT design and implementation. Various challenges arise when applying these considerations due to the nature of nursing interventions and ethical concerns. Proposed solutions include comprehensive informed consent, mixed-methods approaches, and the cluster-randomization process. This paper underscores the role of nurse researchers in overcoming challenges and fostering evidence-based practice. Integrating robust methodological strategies and ethical considerations ensures the validity and reliability of nursing RCTs, contributing to improved patient care. [ABSTRACT FROM AUTHOR]

Objectives: The aim of this study was to assess the measurement equivalence of individual response scale types by using a patient reported outcome measure (PROM) collected on paper and migrated into electronic format for use on the subject's own mobile device (BYOD) and on a provisioned device (site device).Methods: Subjects suffering from chronic health conditions causing daily pain or discomfort were invited to participate in this single-site, single visit, three-way crossover study. Association between individual item and instrument subscale scores was assessed by using the intraclass correlation coefficient (ICC) and its CI. Participant attitudes toward the use of BYOD in a clinical trial were assessed through use of a questionnaire.Results: In this study, 155 subjects (females 83 [54%]; males 72 [46%]) ages 19 to 69 years (mean ± SD: 48.6 ± 13.1) were recruited. High association between the modes of administration (paper, BYOD, site device) was shown with analysis of ICCs (0.79-0.98) for each response scale type, including visual analogue scale, numeric rating scale, verbal response scale, and Likert scale. Of the subjects, 94% (146 of 155) stated that they would definitely or probably be willing to download an app onto their own mobile device for a forthcoming clinical trial. Forty-five percent of subjects felt BYOD would be more convenient compared with 15% preferring a provisioned device (40% had no preference).Conclusions: This study provides strong evidence supporting the use of BYOD for PROM collection in terms of the conservation of instrument measurement equivalence across the most widely used response scale types, and high patient acceptance of the approach. [ABSTRACT FROM AUTHOR]

Background: Weight loss interventions have not been advocated for overweight/obese older adults due to potential loss of skeletal muscle and strength impacting on physical function with potential loss of independence. Carotenoids and polyphenols are inversely associated with sarcopenic symptomology. This paper reports the protocol of a study evaluating the efficacy of a high-protein, energy restricted diet rich in carotenoids and polyphenols on body composition, muscle strength, physical performance and quality of life in overweight and obese older adults.Methods: This randomised controlled clinical trial will recruit community-dwelling, healthy overweight and obese older adults (≥60 years) for a 12-week weight loss intervention. Seventy-three participants will be recruited and randomized to an energy restricted (~30% restriction), isocaloric diet (30% protein; 30% carbohydrate; 40% fat) enriched with either: a) 375 g/d of high carotenoid vegetables, 300 g/d high carotenoid fruit, and 40-60 ml extra-virgin olive oil (EVOO); or b) 375 g/d of lower carotenoid vegetables, 300 g/d lower carotenoid fruit, and 40-60 ml Polyunsaturated fatty acid (PUFA) based oil. All participants will receive individual dietary counselling each fortnight for the duration of the study and will be asked to maintain their habitual level of physical activity throughout the study. The primary outcome will be appendicular skeletal muscle (ASM) assessed by dual energy X-ray absorptiometry (DXA). Secondary outcomes will include body weight, fat-free mass (FFM), fat mass (FM), muscle strength (Isometric hand-grip strength), physical performance (Short Physical Performance Battery), physical activity (International Physical Activity Questionnaire) and health related quality of life (SF-36). Outcomes will be measured at baseline and at week 12.Discussion: The results of this study will provide a novel insight relating to the potential influence of high carotenoid and polyphenol intakes on attenuation of ASM during dietary energy-restricted weight loss in overweight and obese older adults.Trial Registration: The trial was registered on the Australia New Zealand Clinical Trials Register ( ACTRN12616001400459 ); Trial registration date: 10th October, 2016. [ABSTRACT FROM AUTHOR]

Background: While hearing aids for a contralateral routing of signals (CROS-HA) and bone conduction devices have been the traditional treatment for single-sided deafness (SSD) and asymmetric hearing loss (AHL), in recent years, cochlear implants (CIs) have increasingly become a viable treatment choice, particularly in countries where regulatory approval and reimbursement schemes are in place. Part of the reason for this shift is that the CI is the only device capable of restoring bilateral input to the auditory system and hence of possibly reinstating binaural hearing. Although several studies have independently shown that the CI is a safe and effective treatment for SSD and AHL, clinical outcome measures in those studies and across CI centers vary greatly. Only with a consistent use of defined and agreed-upon outcome measures across centers can high-level evidence be generated to assess the safety and efficacy of CIs and alternative treatments in recipients with SSD and AHL.Methods: This paper presents a comparative study design and minimum outcome measures for the assessment of current treatment options in patients with SSD/AHL. The protocol was developed, discussed, and eventually agreed upon by expert panels that convened at the 2015 APSCI conference in Beijing, China, and at the CI 2016 conference in Toronto, Canada.Results: A longitudinal study design comparing CROS-HA, BCD, and CI treatments is proposed. The recommended outcome measures include (1) speech in noise testing, using the same set of 3 spatial configurations to compare binaural benefits such as summation, squelch, and head shadow across devices; (2) localization testing, using stimuli that rove in both level and spectral content; (3) questionnaires to collect quality of life measures and the frequency of device use; and (4) questionnaires for assessing the impact of tinnitus before and after treatment, if applicable.Conclusion: A protocol for the assessment of treatment options and outcomes in recipients with SSD and AHL is presented. The proposed set of minimum outcome measures aims at harmonizing assessment methods across centers and thus at generating a growing body of high-level evidence for those treatment options. [ABSTRACT FROM AUTHOR]

Aim: The aim of this article was to develop and apply an Internet-based headache diary (i-diary) for adolescents and compare it with a paper-diary (p-diary) regarding adherence, user acceptability and recorded headache activity.Methods: In a cross-sectional school-based study, a representative sample of 488 adolescents aged 12-18 years were randomly allocated by cluster sampling to record for three weeks in i-diaries or p-diaries their headache intensity, disability, and use of acute medication.Results: A significantly (p = 0.008) higher proportion of adolescents in the i-diary group used the diary at least once during the 21-day period (86% vs 76% for the p-diary). However, the p-diary group completed a significantly (p < 0.001) higher number of diary days (20.8 vs 15.0 days for the i-diary). The response rate for the i-diary-group was largely evenly distributed over the study period; conversely, approximately two-thirds of the adolescents using the p-diary responded on all 21 days, whereas one-fourth did not respond at all. The two diary types were rated as equal in easiness to remember (p = 0.25), but the i-diaries were more bothersome to use (p = 0.029).Conclusion: Although p-diary users completed a higher proportion of diary days, i-diaries provided more reliable and credible estimates of headache parameters because of better real-time assessment. [ABSTRACT FROM AUTHOR]

Objective: Bleeding data in contraceptive trials are often collected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection.Study Design: This trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experienced during the 90 days after intrauterine device (IUD) insertion. Participants chose either the copper T380A or the 52-mg levonorgestrel IUD. Our primary outcome was number of days of reported bleeding data. We hypothesized that data gathered with daily text messages would have fewer missing values than paper diaries. Intention to treat analyses used the rank-sum test to compare medians.Results: Two hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. With 90 days of reporting, approximately 20% in each group provided complete bleeding data. The text group reported a median of 82 days [interquartile range (IQR) 40-89] and the paper group reported a median of 36 days (IQR 0-88) (p≤.001). The number of responses received decreased gradually over the 90-day period but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while response rates of text messages were greater among those with a high school education or less (p<.01).Conclusions: Participants reporting bleeding via text messages provided more complete data than women using paper diaries.Implications: Depending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes. [ABSTRACT FROM AUTHOR]

Background: Identifying critical life transitions in people's physical activity behaviors may illuminate the most opportune intervention apertures for chronic disease prevention. A substantive evidence base now indicates that parenthood is one of these critical transition points for physical activity decline. This study will examine whether a brief theory-based intervention can prevent a decline in physical activity among new parents over 6 months following intervention. This study protocol represents the first dyad-based physical activity initiative in the parenthood literature involving both mothers and fathers; prior research has focused on only mothers or only fathers (albeit limited), and has shown only short-term changes in physical activity. This study will be investigating whether a theory-based physical activity intervention can maintain or improve moderate to vigorous intensity physical activity measured via accelerometry of new parents over a 6 month period following intervention compared to a control group.Methods: This study is a 6-month longitudinal randomized controlled trial. Parents are measured at baseline (2 months postpartum) with two assessment points at 6 weeks (3.5 months postpartum) and 3 months (5 months postpartum) and a final follow-up assessment at 6 months (8 months postpartum). The content of the theory-based intervention was derived from the results of our prior longitudinal trial of new parents using an adapted theory of planned behavior framework to predict changes in physical activity.Results: A total of 152 couples have been recruited to date. Sixteen couples dropped out after baseline and a total of 88 couples have completed their 6-month measures.Discussion: If the intervention proves successful, couple-based physical activity promotion efforts among parents could be a promising avenue to pursue to help mitigate the declines of physical activity levels during parenthood. These findings could inform public health materials and practitioners.Trial Registration: This trial has been registered with the Clinical Trials Registry maintained by the National Library of Medicine at the National Institutes of Health on April 19, 2014. The registration ID is NCT02290808 . [ABSTRACT FROM AUTHOR]

Background: Major international guidelines recommend mental health screening during the perinatal period. However, substantial barriers to screening have been reported by pregnant and postpartum women and perinatal care providers. E-screening offers benefits that may address implementation challenges.Objective: The primary objective of this randomized controlled trial was to evaluate the feasibility and acceptability of Web-based mental health e-screening compared with paper-based screening among pregnant women. A secondary objective was to identify factors associated with women's preferences for e-screening and disclosure of mental health concerns.Methods: Pregnant women recruited from community and hospital-based antenatal clinics and hospital-based prenatal classes were computer-randomized to a fully automated Web-based e-screening intervention group or a paper-based control group. Women were eligible if they spoke or read English, were willing to be randomized to e-screening, and were willing to participate in a follow-up diagnostic interview. The intervention group completed the Antenatal Psychosocial Health Assessment and the Edinburgh Postnatal Depression Scale on a tablet computer, while controls completed them on paper. All women completed self-report baseline questions and were telephoned 1 week after randomization by a blinded research assistant for a MINI International Neuropsychiatric Interview. Renker and Tonkin's tool of feasibility and acceptability of computerized screening was used to assess the feasibility and acceptability of e-screening compared with paper-based screening. Intention-to-treat analysis was used. To identify factors associated with preference for e-screening and disclosure, variables associated with each outcome at P<.20 were simultaneously entered into final multivariable models to estimate adjusted odds ratios (AORs) and 95% CIs.Results: Of the 675 eligible women approached, 636 agreed to participate (participation rate 94.2%) and were randomized to the intervention (n=305) or control (n=331) groups. There were no significant baseline differences between groups. More women in the e-screening group strongly or somewhat agreed that they would like to use a tablet for answering questions on emotional health (57.9%, 175/302 vs 37.2%, 121/325) and would prefer using a tablet to paper (46.0%, 139/302 vs 29.2%, 95/325), compared with women in the paper-based screening group. There were no differences between groups in women's disclosure of emotional health concerns (94.1%, 284/302 vs 90.2%, 293/325). Women in the e-screening group consistently reported the features of e-screening more favorably than controls (more private or confidential, less impersonal, less time-consuming). In the multivariable models, being in the e-screening group was significantly associated with preferring e-screening (AOR 2.29, 95% CI 1.66-3.17), while no factors were significantly associated with disclosure.Conclusions: The findings suggest that mental health e-screening is feasible and acceptable to pregnant women.Trial Registration: Clinicaltrials.gov NCT01899534; https://clinicaltrials.gov/ct2/show/NCT01899534 (Archived by WebCite at http://www.webcitation.org/6ntWg1yWb). [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: Fermentation is a widely used method of natural food preservation that has consequences on the nutritional value of the transformed food. Fermented dairy products are increasingly investigated in view of their ability to exert health benefits beyond their nutritional qualities.Objective: To explore the mechanisms underpinning the health benefits of fermented dairy intake, the present study followed the effects of milk fermentation, from changes in the product metabolome to consequences on the human serum metabolome after its ingestion.Methods: A randomized crossover study design was conducted in 14 healthy men [mean age: 24.6 y; mean body mass index (in kg/m2): 21.8]. At the beginning of each test phase, serum samples were taken 6 h postprandially after the ingestion of 800 g of a nonfermented milk or a probiotic yogurt. During the 2-wk test phases, subjects consumed 400 g of the assigned test product daily (200 g, 2 times/d). Serum samples were taken from fasting participants at the end of each test phase. The serum metabolome was assessed through the use of LC-MS-based untargeted metabolomics.Results: Postprandial serum metabolomes after milk or yogurt intake could be differentiated [orthogonal projections to latent structures discriminant analysis (OPLS-DA) Q2 = 0.74]. Yogurt intake was characterized by higher concentrations of 7 free amino acids (including proline, P = 0.03), reduced concentrations of 5 bile acids (including glycocholic acid, P = 0.04), and modulation of 4 indole derivative compounds (including indole lactic acid, P = 0.01). Fasting serum samples after 2 wk of daily intake of milk or yogurt could also be differentiated based on their metabolic profiles (OPLS-DA Q2 = 0.56) and were discussed in light of the postprandial results.Conclusion: Metabolic pathways related to amino acids, indole derivatives, and bile acids were modulated in healthy men by the intake of yogurt. Further investigation to explore novel health effects of fermented dairy products is warranted.This trial was registered at clinicaltrials.gov as NCT02230345. [ABSTRACT FROM AUTHOR]

Background: The Institute of Medicine recommends Survivorship Care Plans (SCPs) for all cancer survivors. However, it is unclear whether certain patient groups may or may not benefit from SCPs.Objective: The aim was to assess whether the effects of an automatically generated paper SCP on patients' satisfaction with information provision and care, illness perceptions, and health care utilization were moderated by disease-related Internet use.Methods: Twelve hospitals were randomized to either SCP care or usual care in the pragmatic cluster randomized Registrationsystem Oncological GYnecology (ROGY) Care trial. Newly diagnosed endometrial cancer patients completed questionnaires after diagnosis (N=221; response: 74.7%, 221/296), 6 months (n=158), and 12 months (n=147), including patients' satisfaction with information provision and care, illness perceptions, health care utilization (how many times patients visited a medical specialist or primary care physician about their cancer in the past 6 months), and disease-related Internet use (whether patients used the Internet to look for information about cancer).Results: In total, 80 of 221 (36.2%) patients used the Internet to obtain disease-related information. Disease-related Internet use moderated the SCP care effect on the amount of information received about the disease (P=.03) and medical tests (P=.01), helpfulness of the information (P=.01), and how well patients understood their illness (P=.04). All stratified analyses were not statistically significant. However, it appeared that patients who did not seek disease-related information on the Internet in the SCP care arm reported receiving more information about their disease (mean 63.9, SD 20.1 vs mean 58.3, SD 23.7) and medical tests (mean 70.6, SD 23.5 vs mean 64.7, SD 24.9), finding the information more helpful (76.7, SD 22.9 vs mean 67.8, SD 27.2; scale 0-100), and understanding their illness better (mean 6.6, SD 3.0 vs mean 6.1, SD 3.2; scale 1-10) than patients in the usual care arm did. In addition, although all stratified analyses were not significant, patients who did seek disease-related information on the Internet in the SCP care arm appeared to receive less information about their disease (mean 65.7, SD 23.4 vs mean 67.1, SD 20.7) and medical tests (mean 72.4, SD 23.5 vs mean 75.3, SD 21.6), did not find the information more helpful (mean 78.6, SD 21.2 vs mean 76.0, SD 22.0), and reported less understanding of their illness (mean 6.3, SD 2.8 vs mean 7.1, SD 2.7) than patients in the usual care arm did.Conclusions: Paper SCPs appear to improve the amount of information received about the disease and medical tests, the helpfulness of the information, and understanding of the illness for patients who do not search for disease-related information on the Internet. In contrast, paper SCPs do not seem beneficial for patients who do seek disease-related information on the Internet.Trial Registration: ClinicalTrials.gov NCT01185626; https://clinicaltrials.gov/ct2/show/NCT01185626 (Archived by WebCite at http://www.webcitation.org/6fpaMXsDn). [ABSTRACT FROM AUTHOR]

Introduction: Virtual reality (VR) technology is a potential method to use in cognitive intervention, but the use of VR in cognitive stimulation intervention for older adults has not been investigated. Therefore, the aim of this study was to investigate the mood change of older adults after participating in the VR cognitive stimulation activity.Methods: This is a multicenter randomized controlled, cross-over trial. The intervention was a VR cognitive stimulation activity, and the control was a paper-and-pencil activity. The participants were older adults with age over 60 and recruited in the elderly community centers. The Positive and Negative Affect Score (PANAS) was used to measure mood change. Mean difference (MD) with 95% confidence interval (95% CI) was calculated. The Simulator sickness questionnaire was used to measure adverse events.Results: A total of 236 participants from 19 community centers were recruited. After the VR activity, the participants had a significant increase in total PANAS positive affect score (MD = 2.09, 95% CI = 0.69 to 3.49), and a significant reduction in total negative affect score (MD = -1.99, 95% CI = -2.55 to -1.43). The reduction in negative affect score was significantly larger in VR activity than paper-and-pencil activity (MD = -0.48, 95% CI = -0.98 to 0.00). Besides, only three participants reported severe advance events after VR activity.Conclusions: The use of VR technology is well accepted by older adults. Therefore, the use of VR technology through smartphone and a mobile app can be a potential method for future cognitive training interventions. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of font size and paper thickness on the response to, and completion of, a self-completion postal questionnaire among older people with joint pain.Study Design and Setting: Randomized trial. People aged 50 years and older with joint pain who consulted a general practitioner at one of five general practices in Central Cheshire were sent a postal questionnaire. Questionnaire format (large or small font size, thick or thin paper) was randomly allocated using a 2 x 2 factorial design.Results: Questionnaires were received from 502 out of 650 participants (crude response 77%). Response was significantly higher for participants receiving questionnaires with a larger font size (79.3% vs. 75.2%; hazard ratio 1.26, 95% confidence interval: 1.02, 1.56). Paper thickness had no significant effect on response. Completion (measure by assessing double-page turnover error) was increased in participants receiving questionnaires printed on thicker paper (3.2% vs. 7.1%; P=0.049) but was not affected by font size.Conclusion: This study demonstrates that questionnaires in larger font and on thicker paper may produce higher and more complete responses than surveys using standard size font and standard thickness paper, and should therefore be considered in studies among older people. [ABSTRACT FROM AUTHOR]

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

Factors related to the research context, such as inquiry mode, setting, and experimenter contact, may affect participants' comfort with and willingness to disclose certain sexual attitudes or admit to engaging in sensitive sexual behaviors. In this study, 255 female undergraduates (42.7 % non-White) completed a survey containing measures of sexual behavior and attitudes. The level of experimenter contact (high vs. low contact), setting (in lab vs. out of lab), and inquiry mode (pencil-and-paper vs. computer) were manipulated and participants were randomly assigned to conditions. We hypothesized that low-contact, out-of-lab, computer conditions would be associated with more liberal sexual attitudes and higher rates of reported sexual behaviors than high-contact, in-lab, and paper-and-pencil conditions, respectively. Further, we hypothesized that effects would be moderated by race, such that differences would be greater for non-White participants because of concerns that reporting socially undesirable behavior might fuel racial stereotypes. For attitudinal measures, White participants endorsed more liberal attitudes toward sex in high-contact conditions and non-White participants endorsed more liberal attitudes in low-contact conditions. For behavioral measures, non-White participants reported more behaviors on pencil-and-paper surveys than on computers. White participants demonstrated no significant mode-related differences or reported more sexual behaviors in computer conditions than paper-and-pencil conditions. Overall, results suggest that experimenter contact and mode significantly impact sexual self-report and this impact is often moderated by race. [ABSTRACT FROM AUTHOR]

Background: The study purpose was to compare the effectiveness of monthly or quarterly peer reminder knowledge translation interventions, with monthly or quarterly paper-based reminders, to sustain a mobility innovation, the sit-to-stand activity.Method: A cluster RCT using a stratified 2 × 2 factorial design was conducted in 24 Canadian residential care facilities with 416 residents and 54 peer reminder care aides. The 1-year intervention included two intensities of reminders (high: socially based peer reminders delivered by volunteer care aides to other care aides; low: paper-based reminders posted in residents' rooms), at two frequencies (monthly; every 3 months). Intervention fidelity was assessed using questionnaires and observations. Monthly sustainability rate of the sit-to-stand activity was calculated as the percentage of opportunities that residents successfully completed the activity in 30 days. Residents' sustainability rates were analyzed using a linear mixed model that mirrored the clustered repeated-measures factorial trial design. The model included a random intercept to account for clustering within sites. An unstructured covariance structure characterized the interdependence of repeated measures over time.Results: Twenty-four sites were randomized. One site was excluded because of falsifying data, leaving 23 sites and 349 residents for intention-to-treat analysis. Paper reminders were implemented with high fidelity across all arms (91.5% per protocol), while the peer reminders were implemented with moderate fidelity in the monthly group (81.0% per protocol) and poor fidelity in the quarterly group (51.7% per protocol). At month 1, mean sustainability ranged from 40.7 to 47.2 per 100 opportunities, across the four intervention arms (p = 0.43). Mean rate of sustainability in the high intensity, high frequency group diverged after randomization, yielding statistically significant differences among the groups at 4 months which persisted for the remainder of the trial. After 12 months, the mean sustainability in the high intensity, high frequency group was approximately twice that of the other three groups combined (64.1 versus 37.8 per 100 opportunities, p < 0.001).Conclusions: A monthly peer reminder intervention was more effective than a quarterly peer reminder intervention, a monthly paper-based reminder intervention, and a quarterly paper-based reminder intervention, in supporting care aides to sustain a mobility innovation in residential care facilities over 1 year.Trial Registration: ClinicalTrials.gov , NCT01746459. Registered 11 December 2012: https://clinicaltrials.gov/ct2/show/NCT01746459 . [ABSTRACT FROM AUTHOR]

Background: Anxiety disorder is the most prevalent psychiatric disorder. Benzodiazepines, which are often used for anxiety in patients with anxiety disorder, have various side effects. Lavender, one of the most commonly used essential oils in aromatherapy, has the potential to reduce benzodiazepine use for anxiety disorders. Methods: This study is a multicenter, double-masked, randomized, placebo-controlled clinical trial. The study will recruit patients aged 20–59 years old with generalized anxiety disorder and panic disorder among anxiety disorders. The bottle containing the test solution (lavender aroma essential oil or distilled water) will be given to the patients. Patients will carry the bottles with them in their daily life and use the drops on tissue paper when anxious. The primary endpoint is the number of times anxiolytics used in 28 days. Discussion: If the use of benzodiazepines could be reduced by sniffing lavender aroma, which is inexpensive and safe, it would contribute not only to the risks associated with benzodiazepine use but also to the health care economy and could even be added as a standard treatment. Trial registration: University hospital Medical Information Network Clinical Trials Registry (UMIN-CTR), ID: UMIN000034422 Registered 17 January 2019. [ABSTRACT FROM AUTHOR]

Background: Effective web-assisted tobacco interventions (WATIs) have been underutilized by smokers; moreover, despite practice guideline recommendations, clinical teams do not routinely refer smokers to WATIs. Our goal was to test a clinical practice innovation, an ePortal designed to change practice and patient behavior. Our hypotheses were that the integrated system would result in increased smoker referrals, with an automated follow-up system resulting in more smoker registrations and finally augmentations of the WATI would result in more smokers quitting at 6 months.Methods: Practice ePortal Implementation Trial: Practices (n = 174) were randomized to an online practice ePortal with an "e-referral tool" to the WATI (e-referred smokers received automated email reminders from the practice) and with practice feedback reports with patient tracking and practice-to-patient secure messaging versus comparison (a paper "referral prescription"). Implementation success was measured by the number of smokers referred and smokers registering. Clinical Effectiveness Trial: To estimate the effectiveness of the WATI components on 6-month smoking cessation, registered smokers were randomized into three groups: a state-of-the-art tailored WATI control [control], the WATI enhanced with proactive, pushed tailored email motivational messaging (messaging), and the WATI with messaging further enhanced with personal secure messaging with a tobacco treatment specialist and an online support group (personalized).Results: Practice ePortal Trial results: A total of 4789 smokers were referred. The mean smokers referred per practice was not statistically different by group (ePortal 24.89 (SD 22.29) versus comparison 30.15 (SD 25.45), p = 0.15). The e-referral portal implementation program resulted in nearly triple the rate of smoker registration (31 % of all smokers referred registered online) versus comparison (11 %, p < 0.001). Clinical Effectiveness Trial results: Active smokers randomized to the personalized group had a 6-month cessation rate of 25.2 %, compared with the messaging group (26.7 %) and the control (17 %). Next, when using an inverse probability weighted selection model to account for attrition, those randomized to the two groups that received motivational messaging (messaging or personalized) were more likely to quit than those in the control (p = 0.04).Conclusions: Among all smokers referred, the e-referral resulted in nearly threefold greater registrants (31 %) than paper (11 %). The practice ePortal smokers received multiple reminders (increasing registration opportunities), and the practices could track patient progress. The result was more smokers registering and, thus, more cessation opportunities. Combining the proactive referral and the WATI resulted in higher rates of smoking cessation.Trial Registration: Web-delivered Provider Intervention for Tobacco Control (QUIT-PRIMO) - a randomized controlled trial: NCT00797628 . [ABSTRACT FROM AUTHOR]

Purpose: To evaluate the efficiency of the electronic foot function index (eFFI) through a prospective, random based, multi-institutional study. Materials and Methods: The study included 227 patients ranging in age from 20 to 79 years, visited for surgery in different 15 institutes, and agreed to volunteer. The patients were assigned randomly into a paper-based evaluated group (n=113) and tablet-based evaluated group (n=114). The evaluation was done on the day of hospital admission and the method was changed on the second day of surgery and re-evaluated. PADAS 2.0 (https://www.proscore.kr) was used as an electronic evaluation program. Results: There were no differences in age and sex in both groups. The intraclass correlation coefficient (ICC) evaluation revealed an eFFI ICC of 0.924, showing that both results were similar. The evaluation time was shorter in the tablet-based group than the paperbased group (paper vs tablet, 3.7±3.8 vs 2.3±1.3 minutes). Thirty-nine patients (17.2%) preferred to use paper and 131 patients (57.7%) preferred the tablet. Fifty-seven patients (25.1%) found both ways to be acceptable. Conclusion: eFFI through tablet devices appears to be more constant than the paper-based program. In addition, it required a shorter amount of time and the patients tended to prefer the tablet-based program. Overall, tablet and cloud system can be beneficial to a clinical study. [ABSTRACT FROM AUTHOR]

The need for developing effective telehealth tools for dysphagia management is high not only for people who live in rural areas, but also for individuals with mobility/access limitations. We aimed to develop an electronic case History Tool/form (thereafter, e-HiT) for dysphagia, and compare its effectiveness with its paper-based version (PBV) on completion time, completeness, independence, and patient perceptions/satisfaction. Secondarily, we examined associations between the aforementioned variables and predictor variables, such as age, cognition, and computer/internet use. Forty adults who expressed concerns with eating/swallowing participated. To compare both versions, a randomized, controlled two-period crossover design was used. In Visit 1, Group A completed the e-HiT and Group B completed the PBV. In Visit 2, Group A completed the PBV and Group B completed the e-HiT. A satisfaction survey was completed post visits. There were no statistically significant differences for completion time (p = 0.743), completeness (p = 0.486), and independence (p = 0.738). Patient perception/satisfaction was significantly higher with the e-HiT (p = 0.004). In addition, a significant association was found between completion time and age (p = 0.0063). Our results indicate that completing the e-HiT is as time efficient as completing the PBV and that both forms elicit the same amount of information with no or minimal support. Also, completion of the e-HiT yielded significantly higher satisfaction responses. This is the first study documenting the effectiveness of the e-HiT for outpatients with dysphagia, providing evidence that the first step of a swallowing assessment-case history completion-can be effectively completed via telehealth by individuals with reliable internet connection and basic computer literacy skills. [ABSTRACT FROM AUTHOR]

To undertake a literature search and critical appraisal of best available evidence to answer the clinical question: Does the addition of clonidine (I) to standard treatment with an opioid (C) improve outcomes (O) in infants with Neonatal Abstinence Syndrome? A search of both comprehensive (MedLine and Embase) and pre-filtered databases (Dynamed, UpToDate and TRIP), utilising Boolean Operators to combine search terms appropriately. Three relevant studies were identified. One paper describing the outcomes of a randomised controlled trial by Agthe et al. (2009) most accurately answered the clinical question posed. This paper was critically appraised, and evidence applied to the clinical scenario. The use of clonidine as an adjunct to opioid in the management of infants with NAS reduces the total number of treatment days and dose of opioid required to control symptoms. However, there is a higher risk of rebound in symptoms post-cessation of opioid and clinicians need to account for this in their discharge planning. More large scale, multi-centre high-quality research is needed to clarify the role of clonidine in the treatment of NAS: as monotherapy versus adjunct, the optimal dose and longer-term impact on neurodevelopment. [ABSTRACT FROM AUTHOR]

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

Purpose: Prevalence rates of older adults (OA, 50+) with high-risk alcohol use are rapidly growing. Barriers to intervention persist for OA. Mobile interventions, specifically short message service (SMS, also known as text messaging), provide an opportunity to overcome such barriers. The purpose of this paper is to explore the acceptability and preliminary effectiveness of four SMS intervention conditions compared to mobile assessment only among OA (50–65 years old, n = 49) who drink at high-risk levels compared to younger adults (YA, 21–49 years old, n = 102). Design/methodology/approach: Within and between age group differences at baseline and end-of-treatment (12 weeks) were explored. Generalized linear modeling was used to test age by receipt of any SMS intervention (compared to assessment only) effects across health outcomes. Effect sizes and visual analyses were generated to assess for age by type of SMS interactions. Findings: Both age groups reported intervention satisfaction. Two-thirds elected to continue receiving SMSs after treatment concluded. Descriptively, SMS groups demonstrated reduced drinking across age groups at end-of-treatment compared to mobile assessment only, though slightly larger effects were found for YA than for OA. Age significantly moderated the receipt of any SMS intervention only for depression (i.e., older age weakened the therapeutic effect). Of all the SMS types, tailored messages outperformed the other conditions on drinking outcomes for both age groups. Depression, craving and alcohol problems responded to gain-framed messages among OA and loss-framed messages among YA. Research limitations/implications: The findings of this paper suggest that SMS is acceptable and potentially effective across age groups. Further adaptation of SMS across age groups could enhance its effectiveness. Originality/value: This is the first paper to explore the impact of older age on the efficacy of text messaging as an intervention for hazardous alcohol use. [ABSTRACT FROM AUTHOR]

Purpose: In a randomised controlled trial, patients were offered financial incentives to improve their adherence to anti-psychotic maintenance medication. Compared to a control group without the incentives, they had an improved adherence and also better subjective quality of life (SQOL) after 1 year. This paper explores the question as to whether this improvement in SQOL was associated with the amount of money received or with the improved adherence itself.Method: A secondary analysis was performed using data of the experimental group in the trial. Adherence was assessed as the percentage of all prescribed long-acting anti-psychotic injections that were taken by the patient. In regression models, we tested whether changes in medication adherence and/or the amount of incentives received over the 12-month period was associated with SQOL, as rated on the DIALOG scale.Results: Adherence changed from 68.49 % at baseline to 88.23 % (mean difference in adherence = 19.59 %, SD = 17.52 %). The total amount of incentives received within the 1-year study period varied between £75 and £735, depending on the treatment cycle and the number of long-acting injections taken. Improvement in adherence was found to be a significant predictor of better subjective quality of life (β = 0.014, 95 % CI 0.003-0.025, p = 0.014), whilst the amount of incentives received was not (β = 0.0002, 95 % CI -0.002 to 0.002, p = 0.818).Conclusion: Improved medication adherence is associated with a more favourable SQOL. This underlines the clinical relevance of improved adherence in response to financial incentives in this patient group. [ABSTRACT FROM AUTHOR]

Background: The PACE Steps to Success programme is a complex educational and development intervention to improve palliative care in nursing homes. Little research has investigated processes in the cross-cultural adaptation and implementation of interventions in palliative care across countries, taking account of differences in health and social care systems, legal and regulatory policies, and cultural norms. This paper describes a framework for the cross-cultural development and support necessary to implement such an intervention, taking the PACE Steps to Success programme as an exemplar.Methods: The PACE Steps to Success programme was implemented as part of the PACE cluster randomised control trial in seven European countries. A three stage approach was used, a) preparation of resources; b) training in the intervention using a train-the-trainers model; and c) cascading support throughout the implementation. All stages were underpinned by cross-cultural adaptation, including recognising legal and cultural norms, sensitivities and languages. This paper draws upon collated evidence from minutes of international meetings, evaluations of training delivered, interviews with those delivering the intervention in nursing homes and providing and/or receiving support.Results: Seventy eight nursing homes participated in the trial, with half randomized to receive the intervention, 3638 nurses/care assistants were identified at baseline. In each country, 1-3 trainers were selected (total n = 16) to deliver the intervention. A framework was used to guide the cross-cultural adaptation and implementation. Adaptation of three English training resources for different groups of staff consisted of simplification of content, identification of validated implementation tools, a review in 2 nursing homes in each country, and translation into local languages. The same training was provided to all country trainers who cascaded it into intervention nursing homes in local languages, and facilitated it via in-house PACE coordinators. Support was cascaded from country trainers to staff implementing the intervention.Conclusions: There is little guidance on how to adapt complex interventions developed in one country and language to international contexts. This framework for cross-cultural adaptation and implementation of a complex educational and development intervention may be useful to others seeking to transfer quality improvement initiatives in other contexts. [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]

Background & Aim: To assess consonant proficiency and velopharyngeal function in 10‐year‐old children born with unilateral cleft lip and palate (UCLP) within the Scandcleft project. Methods & Procedures: Three parallel group, randomized, clinical trials were undertaken as an international multicentre study by nine cleft teams in five countries. Three different surgical protocols for primary palate repair (Arm B–Lip and soft palate closure at 3–4 months, hard palate closure at 36 months, Arm C–Lip closure at 3–4 months, hard and soft palate closure at 12 months, and Arm D–Lip closure at 3–4 months combined with a single‐layer closure of the hard palate using a vomer flap, soft palate closure at 12 months) were tested against a common procedure (Arm A–Lip and soft palate closure at 3–4 months followed by hard palate closure at 12 months) in the total cohort of 431 children born with a non‐syndromic UCLP. Speech audio and video recordings of 399 children were available and perceptually analysed. Percentage of consonants correct (PCC) from a naming test, an overall rating of velopharyngeal competence (VPC) (VPC‐Rate), and a composite measure (VPC‐Sum) were reported. Outcomes & Results: The mean levels of consonant proficiency (PCC score) in the trial arms were 86–92% and between 58% and 83% of the children had VPC (VPC‐Sum). Only 50–73% of the participants had a consonant proficiency level with their peers. Girls performed better throughout. Long delay of the hard palate repair (Arm B) indicated lower PCC and simultaneous hard and soft palate closure higher (Arm C). However, the proportion of participants with primary VPC (not including velopharyngeal surgeries) was highest in Arm B (68%) and lowest in Arm C (47%). Conclusions & Implications: The speech outcome in terms of PCC and VPC was low across the trials. The different protocols had their pros and cons and there is no obvious evidence to recommend any of the protocols as superior. Aspects other than primary surgical method, such as time after velopharyngeal surgery, surgical experience, hearing level, language difficulties and speech therapy, need to be thoroughly reviewed for a better understanding of what has affected speech outcome at 10 years. WHAT THIS PAPER ADDS: What is already known on the subject: Speech outcomes at 10 years of age in children treated for UCLP are sparse and contradictory. Previous studies have examined speech outcomes and the relationship with surgical intervention in 5‐year‐olds. What this study adds to the existing knowledge: Speech outcomes based on standardized assessment in a large group of 10‐year‐old children born with UCLP and surgically treated according to different protocols are presented. While speech therapy had been provided, a large proportion of the children across treatment protocols still needed further speech therapy. What are the potential or actual clinical implications of this work?: Aspects other than surgery and speech function might add to the understanding of what affects speech outcome. Effective speech therapy should be available for children in addition to primary surgical repair of the cleft and secondary surgeries if needed. [ABSTRACT FROM AUTHOR]

Background: In 2001, Good and Stafford published a study attempting to show that inpatient palliative medicine is evidence-based. Aim: To critically examine the papers cited in support of the claim that palliative medicine is evidence-based. Method: All the papers cited were re-examined by at least two reviewers. The papers were graded using a tool used in the production of 22 evidence-based national clinical guidelines over the past three years. Differences of opinion about quality were resolved by discussion or independent arbitration. Results: The 41 papers cited by Good and Stafford included 25 randomized controlled trials (RCT), six other controlled studies and 10 uncontrolled studies. Sample size. Mean sample size was 160 (range 9-1404). The median sample size was 56; 19/41(46%) had <50 subjects; 30/41 (73%) had <100. Power calculations. 16/25 (64%) of RCTs, had no power calculations, making it difficult to draw conclusions about true differences between groups. Quality rating and grade of evidence: Of the RCTs 15/25 (60%) had a high risk of bias; of the other controlled studies 5/6 (83%) had a high risk of bias. Applicability. The studies were generally applicable to a population with advanced disease: 30/41 (73%) related with populations with advanced disease. Conclusions: This study demonstrates that studies cited in support of palliative medicine as an evidence-based specialty are of variable, and at times poor quality. This study seems to show that the claim that inpatient palliative medicine is evidence-based is at best tenuous and at worst misleading. [ABSTRACT FROM AUTHOR]

Background: Self-interviews, where the respondent rather than the interviewer enters answers to questions, have been proposed as a way to reduce social desirability bias associated with interviewer-led interviews. Computer-assisted self-interviews (CASI) are commonly proposed since the computer programme can guide respondents; however they require both language and computer literacy. We evaluated the feasibility and acceptability of using electronic methods to administer quantitative sexual behaviour questionnaires in the Somkhele demographic surveillance area (DSA) in rural KwaZulu-Natal, South Africa.Methods: We conducted a four-arm randomized trial of paper-and-pen-interview, computer-assisted personal-interview (CAPI), CASI and audio-CASI with an age-sex-urbanicity stratified sample of 504 adults resident in the DSA in 2015. We compared respondents' answers to their responses to the same questions in previous surveillance rounds. We also conducted 48 cognitive interviews, dual-coding responses using the Framework approach.Results: Three hundred forty (67%) individuals were interviewed and covariates and participation rates were balanced across arms. CASI and audio-CASI were significantly slower than interviewer-led interviews. Item non-response rates were higher in self-interview arms. In single-paper meta-analysis, self-interviewed individuals reported more socially undesirable sexual behaviours. Cognitive interviews found high acceptance of both self-interviews and the use of electronic methods, with some concerns that self-interview methods required more participant effort and literacy.Conclusions: Electronic data collection methods, including self-interview methods, proved feasible and acceptable for completing quantitative sexual behaviour questionnaires in a poor, rural South African setting. However, each method had both benefits and costs, and the choice of method should be based on context-specific criteria. [ABSTRACT FROM AUTHOR]

Objective: To determine the effects on weight loss of three abbreviated behavioral weight loss interventions with and without coaching and mobile technology.Methods: A randomized controlled efficacy study of three 6-month weight loss treatments was conducted in 96 adults with obesity: 1) self-guided (SELF), 2) standard (STND), or 3) technology-supported (TECH). STND and TECH received eight in-person group treatment sessions. SELF and STND used paper diaries to self-monitor diet, activity, and weight; TECH used a smartphone application with social networking features and wireless accelerometer.Results: Weight loss was greater for TECH and STND than SELF at 6 months (-5.7 kg [95% confidence interval: -7.2 to -4.1] vs. -2.7 kg [95% confidence interval: -5.1 to -0.3], P < 0.05) but not 12 months. TECH and STND did not differ except that more STND (59%) than TECH (34%) achieved ≥ 5% weight loss at 6 months (P < 0.05). Self-monitoring adherence was greater in TECH than STND (P < 0.001), greater in both interventions than SELF (P < 0.001), and covaried with weight loss (r(84) = 0.36-0.51, P < 0.001).Conclusions: Abbreviated behavioral counseling can produce clinically meaningful weight loss regardless of whether self-monitoring is performed on paper or smartphone, but long-term superiority over standard of care self-guided treatment is challenging to maintain. [ABSTRACT FROM AUTHOR]

Background: The transition from teacher‐centred towards student‐centred approaches in English language teaching, accompanied by developments in educational technology, has attracted researchers' attention to reverse teaching or flipped class. The related literature asserts that this mode of instruction might influence instructors' and students' participation in the class. Objectives: To shed more light on the role of flipped class in affecting language learning strategies and skills, this study applied a sequential explanatory mixed‐methods approach to explore the impact of flipped class on English as a foreign language (EFL) learners' writing metacognitive strategies and writing skills. Methods: Forty‐six intermediate EFL learners with an age range of 21–27, studying at a private language institute, were randomly divided into two groups of 23 learners. The two groups were randomly assigned to a flipped class, which received writing metacognitive strategies and writing skills through video clips before the class time, and a non‐flipped class, which received writing metacognitive strategies and writing skills in a conventional way during the class time. Results and Conclusions: The results revealed that both flipped and non‐flipped classes improved the EFL learners' writing metacognitive strategies, writing performance, writing content, and writing organisation. Furthermore, one‐way ANCOVA analyses indicated that the flipped class outperformed the non‐flipped class in writing metacognitive strategies, writing performance, writing content, and writing organisation. Thematic analyses, which were used to help analyse individual semi‐structured interviews, uncovered a number of categories and themes, signifying the flipped learners' positive perceptions towards the flipped class, such as enhancing motivation, self‐confidence, and writing collaboration. Implications: Pedagogical implications were discussed for flipping writing metacognitive strategies and writing skills. Lay Description: What is already known about this topic?: Metacognitive strategies, including planning, monitoring, and evaluation strategies, help English language learners become more successful writers.Writing skills, including writing content, writing organisation, and language use, help learners deal with collaborative writing activities effectively.Flipped class has been shown to be an effective mode of instruction to improve English language learners' language learning strategies and skills. What this paper adds?: Flipped class improves English language learners' writing metacognitive strategies, writing performance, writing content, and writing organisation.Flipped class is more effective than non‐flipped class in improving English language learners' writing metacognitive strategies and writing skills.English language learners' motivation, self‐confidence, and writing collaboration are increased as a result of the flipped writing course. Pedagogical implications: Writing metacognitive strategies and writing skills need to be flipped in English language contexts in order to free up time for more effective in‐class collaborative writing activities. [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]

Chronic primary low back pain (CPLBP) is a prevalent and disabling condition that often requires rehabilitation interventions to improve function and alleviate pain. This paper aims to advance future research, including systematic reviews and randomized controlled trials (RCTs), on CPLBP management. We provide methodological and reporting recommendations derived from our conducted systematic reviews, offering practical guidance for conducting robust research on the effectiveness of rehabilitation interventions for CPLBP. Our systematic reviews contributed to the development of a WHO clinical guideline for CPLBP. Based on our experience, we have identified methodological issues and recommendations, which are compiled in a comprehensive table and discussed systematically within established frameworks for reporting and critically appraising RCTs. In conclusion, embracing the complexity of CPLBP involves recognizing its multifactorial nature and diverse contexts and planning for varying treatment responses. By embracing this complexity and emphasizing methodological rigor, research in the field can be improved, potentially leading to better care and outcomes for individuals with CPLBP. [ABSTRACT FROM AUTHOR]

Background: Several medications have been applied to Alzheimer's dementia patients (AD) but their efficacies have been insufficient. The efficacy and safety of 4 weeks of repetitive transcranial magnetic stimulation (rTMS) in Japanese AD were evaluated in this exploratory clinical trial. Methods: Forty-two patients, aged 60-93 years (average, 76.4 years), who were taking medication (> 6 months) and had Mini-Mental State Examination (MMSE) scores ≤ 25 and Clinical Dementia Rating Scale scores (CDR-J) of 1 or 2, were enrolled in this single-center, prospective, randomized, three-arm study [i.e., 120% resting motor threshold (120% RMT), 90% RMT for the bilateral dorsolateral prefrontal cortex, and Sham]. Alzheimer's Disease Assessment Scale-Japanese Cognitive (ADAS-J cog), Montreal Cognitive Assessment (MoCA-J), Clinical Global Impression of Change (CGIC), Neuropsychiatric inventory (NPI), and EuroQOL 5 Dimensions 5-Level (EQ-5D-5L) were administered. The primary endpoint was the mean change from baseline in the MMSE score (week 4). An active rTMS session involved applying 15 trains bilaterally (40 pulses/train at 10 Hz; intertrain interval, 26 s). Participants received ≥ 8 interventions within the first 2 weeks and at least one intervention weekly in the 3rd and 4th weeks. Full Analysis set (FAS) included 40 patients [120% RMT (n = 15), 90% RMT (n = 13), and Sham (n = 12)]. Results: In the FAS, MMSE, ADAS-J cog, MoCA-J, CDR-J, CGIC, NPI, and EQ-5D-5L scores between the three groups were not significantly different. Two patients were erroneously switched between the 120% RMT and 90% RMT groups, therefore, "as treated" patients were mainly analyzed. Post hoc analysis revealed significant treatment efficacy in participants with MMSE scores ≥ 15, favoring the 120% RMT group over the Sham group. Responder analysis revealed 41.7% of the 120% RMT group had a ≥ 3-point improvement in the ADAS-J cog versus 0% in the Sham group (Fisher's exact test, p = 0.045). The MoCA-J showed the same tendency but was not significant. Efficacy disappeared in week 20, based on the ADAS-cog and MoCA-J. No intervention-related serious adverse events occurred. Conclusion: This paper is the first report of using rTMS in Japanese AD patients. The treatment seems safe and moderate-mild stage AD should be target population of pivotal clinical trial with 120% RMT rTMS. [ABSTRACT FROM AUTHOR]

Background: Arterial stiffness and calcification propensity are associated with high cardiovascular risk and increased mortality in chronic kidney disease (CKD). Both magnesium and phosphate are recognized as modulators of vascular calcification and chronic inflammation, both features of CKD that contribute to arterial stiffness. In this paper, we outline the rationale and design of a randomized controlled trial (RCT) investigating whether 24 weeks of oral magnesium supplementation with or without additional phosphate-binding therapy can improve arterial stiffness and calcification propensity in patients with stage 3-4 CKD.Methods: In this multi-center, placebo-controlled RCT, a total of 180 participants with an estimated glomerular filtration rate of 15 to 50 ml/min/1.73 m2 without phosphate binder therapy will be recruited. During the 24 weeks intervention, participants will be randomized to one of four intervention groups to receive either magnesium citrate (350 mg elemental magnesium/day) or placebo, with or without the addition of the phosphate binder sucroferric oxyhydroxide (1000 mg/day). Primary outcome of the study is the change of arterial stiffness measured by the carotid-femoral pulse wave velocity over 24 weeks. Secondary outcomes include markers of calcification and inflammation, among others calcification propensity (T50) and high-sensitivity C-reactive protein. As explorative endpoints, repeated 18F-FDG and 18F-NaF PET-scans will be performed in a subset of participants (n = 40). Measurements of primary and secondary endpoints are performed at baseline, 12 and 24 weeks.Discussion: The combined intervention of magnesium citrate supplementation and phosphate-lowering therapy with sucroferric oxyhydroxide, in stage 3-4 CKD patients without overt hyperphosphatemia, aims to modulate the complex and deregulated mineral metabolism leading to vascular calcification and arterial stiffness and to establish to what extent this is mediated by T50 changes. The results of this combined intervention may contribute to future early interventions for CKD patients to reduce the risk of CVD and mortality.Trial Registration: Netherlands Trial Register, NL8252 (registered December 2019), EU clinical Trial Register 2019-001306-23 (registered November 2019). [ABSTRACT FROM AUTHOR]

Background: Despite the growing popularity of mixed-methods studies and considerable emphasis on the potential value of qualitative research to the trial endeavour, there remains a dearth of published studies reporting on actual contribution. This paper presents a critically reflective account of our experience of the actual value of undertaking qualitative research alongside a pilot cluster randomised controlled trial of a guided e-learning intervention for managers in an NHS Mental Health Trust to improve employee wellbeing and reduce sickness absence. For the qualitative study we undertook 36 in-depth interviews with key informants, managers and employees. We observed and took in-depth field notes of 10 meetings involving managers and employees at the Trust, and the two qualitative researchers acted as participant observers at steering committee and monthly research team meetings. We adopted a narrative methodological orientation alongside a thematic approach to data analysis, eliciting a rich account of the complexities of managing stress at work.Results: We identified two key overarching roles played by the qualitative research: 'problematising' and 'contextualising'. Specifically, the qualitative data revealed and challenged assumptions embedded in the trial about the nature of the learning process, and exposed the slippery and contested nature of abstracted variables, on which a trial depends. The qualitative data challenged the trial's logic model, and provided a rich understanding of the context within which the trial and intervention took place.Conclusions: While acknowledging the ever-present tension in mixed-methods research between the requirements of quantitative research to represent the social world as abstracted variables, and the goal of qualitative research to explore and document the complexity of social phenomena, we adopted a pragmatic position that enabled us to engage with this tension in a productive and partially integrative way. Our critically reflective account of the praxis of integration illuminated opportunities and challenges for maximising the value of qualitative research to a trial. This paper sets out tangible illustrative lessons for other mixed-methods researchers endeavouring to get the most from qualitative research.Trial Registration: This study is registered as ISRCTN58661009 . Registration was submitted on 22 April 2013 and completed on 17 June 2013. [ABSTRACT FROM AUTHOR]

Introduction: The South African National Department of Health sought to improve syndromic management of sexually transmitted infections (STIs). Continuing medical education on STIs was delivered at primary healthcare (PHC) clinics using one of three training methods: (1) lecture, (2) computer and (3) paper-based. Clinics with training were compared with control clinics.Methods: Ten PHC clinics were randomly assigned to control and 10 to each training method arm. Clinicians participated in on-site training on six modules; two per week for three weeks. Each clinic was visited by three or four unannounced standardised patient (SP) actors pre-training and post-training. Male SPs reported symptoms of male urethritis syndrome and female SPs reported symptoms of vaginal discharge syndrome. Quality of healthcare was measured by whether or not clinicians completed five tasks: HIV test, genital exam, correct medications, condoms and partner notification.Results: An average of 31% of clinicians from each PHC attended each module. Quality of STI care was low. Pre-training (n=128) clinicians completed an average of 1.63 tasks. Post-training (n=114) they completed 1.73. There was no change in the number of STI tasks completed in the control arm and an 11% increase overall in the training arms relative to the control (ratio of relative risk (RRR)=1.11, 95% CI 0.67 to 1.84). Across training arms, there was a 26% increase (RRR=1.26, 95% CI 0.77 to 2.06) associated with lecture, 17% increase (RRR=1.17, 95% CI 0.59 to 2.28) with paper-based and 13% decrease (RRR=0.87, 95% CI 0.40 to 1.90) with computer arm relative to the control.Conclusions: Future interventions should address increasing training attendance and computer-based training effectiveness.Trial Registration Number: AEARCTR-0000668. [ABSTRACT FROM AUTHOR]

Research in medicine is an indispensable tool to advance knowledge and improve patient care. This may be particularly true in the field of human reproduction as it is a relatively new field and treatment options are rapidly evolving. This is of particular importance in an emerging field like 'human reproduction', where treatment options evolve fast.The cornerstone of evidence-based knowledge, leading to evidence-based treatment decisions, is randomized controlled trials as they explore the benefits of new treatment approaches. The study design and performance are crucial and, if they are carried out correctly, solid conclusions can be drawn and be implemented in daily clinical routines. The dissemination of new findings throughout the scientific community occurs in the form of publications in scientific journals, and the importance of the journal is reflected in part by the impact factor. The peer review process before publication is fundamental in preventing flaws in the study design. Thus, readers of journals with a high impact factor usually rely on a thorough peer review process and therefore might not question the published data. However, even papers published in high-impact journals might not be free of flaws, so the aim of this paper is to encourage readers to be aware of this fact and critically read scientific papers as 'the devil lies in the details'. [ABSTRACT FROM AUTHOR]

The prevalence of randomized controlled trials (RCTs) performed without fully informed prospective consent from subjects is unknown. We performed this study to estimate the prevalence of high-impact RCTs performed without informed consent from all subjects and examine whether such trials are becoming more prevalent. We performed a systematic review of English-language RCTs published from 2014 through 2018 identified in Scopus and sorted to identify the top 100 most highly cited RCTs each year. Text search of title and abstract included terms randomized controlled or clinical trial and spelling variants thereof, and excluded metaanalyses and systematic reviews. We independently identified the most highly cited RCTs based on predefined criteria and negotiated to agreement, then independently performed keyword searches, read, abstracted and coded information regarding informed consent from each paper and again negotiated to agreement. No quality indicators were assessed. We planned descriptive qualitative analysis and appropriate quantitative analysis to examine the prevalence and characteristics of trials enrolling subjects with other than fully informed prospective consent. We find that 44 (8.8%, binomial exact 95% CI 6.5% to 11.6%) of 500 high-impact RCTs did not secure informed consent from at least some subjects. The prevalence of such trials did not change over the 5 years (OR=1.09, z=0.78, p=0.44). A majority (66%) of the trials involved emergency situations, and 40 of 44 (90.9%) of the trials involved emergency interventions, pragmatic designs, were cluster randomized, or a combination of these factors. A qualitative analysis explores the methods of and justifications for waiving informed consent in our sample of RCTs. [ABSTRACT FROM AUTHOR]