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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]

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]

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]

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: 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]

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]

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]

Background: Perceptual, cognitive and previous clinical experience may influence a novice Videofluoroscopic Swallowing Study (VFSS) analyst's trajectory towards competency. Understanding these factors may allow trainees to be better prepared for VFSS training and may allow training to be developed to accommodate differences between trainees. Aims: This study explored a range of factors previously suggested in the literature as influencing the development of novice analysts' VFSS skills. We hypothesised that knowledge of swallow anatomy and physiology, visual perceptual skills, self‐efficacy and interest, and prior clinical exposure would all influence VFSS novice analysts' skill development. Methods & Procedures: Participants were undergraduate speech pathology students recruited from an Australian university, who had completed the required theoretical units in dysphagia. Data assessing the factors of interest were collected—the participants identified anatomical structures on a still radiographic image, completed a physiology questionnaire, completed subsections of the Developmental Test of Visual Processing—Adults, self‐reported the number of dysphagia cases they managed on placement, and self‐rated their confidence and interest. Data for 64 participants relating to the factors of interest were compared with their ability to accurately identify swallowing impairments following 15 h of VFSS analytical training, using correlation and regression analysis. Outcomes & Results: Success in VFSS analytical training was best predicted by clinical exposure to dysphagia cases and the ability to identify anatomical landmarks on still radiographic images. Conclusions & Implications: Novice analysts vary in the acquisition of beginner‐level VFSS analytical skill. Our findings suggest that speech pathologists who are new to VFSS may benefit from clinical exposure to dysphagia cases, sound foundational knowledge of anatomy relevant to swallowing and the ability to see the anatomical landmarks on still radiographic images. Further research is required to equip VFSS trainers and trainees for training, to understand differences between learners during skill development. WHAT THIS PAPER ADDS: What is already known on the subject: The existing literature suggests that no vice Video fluoroscopic Swallowing Study (VFSS) analysts training may be influenced by their personal characteristics and experience. What this study adds: This study found that student clinicians, clinical exposure to dysphagia cases and their ability to identify anatomical landmarks relevant to swallowing on still radiographic images prior to training best predicted their ability to identify swallowing impairments after training. What are the clinical implications of this work?: Given the expense of training health professionals, further research is required into the factors that successfully prepare clinicians for VFSS training, including clinical exposure, foundational knowledge of anatomy relevant to swallowing and the ability to identify the anatomical landmarks on still radiographic images. [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: When interpreting medical images such as dental panoramic radiographs (Orthopanthomogram, OPT), errors are frequent. Previous research has shown that eye movement modelling examples (EMME) are a supportive training method for medical image interpretation to reduce errors. To date, EMME support for OPTs has not been verified. Objectives: We investigated whether a training with EMME and verbal explanations supports dental students in evaluating OPTs. Methods: Dental students were randomly assigned to an intervention (N = 42) or a control group (N = 41). The intervention group received the EMME between pre‐ and post‐test. In a laboratory study, we measured students' gaze behaviour during evaluating OPTs and the detection rate of anomalies. Results and conclusions: The training led to fewer, shorter, and later fixations on anomalies and no difference in visual coverage of the OPT. The detection rate of anomalies did not improve. We replicated the latter finding in an online study (N = 31). Students may not have been able to apply the information from the EMME to detect anomalies. The image reading processes changed to more efficient rather than deeper visual search. Major takeaways: This study evaluated a training method with EMME for anomaly detection of OPTs. EMMEs did not improve the anomaly detection of dental students and changed their visual search process toward a more efficient rather than a deeper search. Lay Description: What is already known about this topic: Dental students and dentists commit many errors when interpreting radiographs.Validated interventions to support radiograph interpretations are lacking.Eye movement modelling examples (EMME) consist of videos showing an expert's gaze behaviour while performing a visual task.EMME improve processing of visual information in other domains (e.g., multimedia learning, chest x‐rays). What this paper adds: We investigated whether EMME improved detection of anomalies and gaze behaviour for dental students.Three EMME videos of dental experts explaining their behaviour and observations were presented to students.Studying the EMME videos did not improve the detection of anomalies.The gaze behaviour changed to a more efficient visual search. Implications for practice and/or policy: EMME do not seem to be effective as a short‐term intervention to improve anomaly detection for dental students.Further research is needed to develop effective training methods that could be applied in university teaching. [ABSTRACT FROM AUTHOR]

Introduction: Occupational therapy often involves handwriting acquisition practices that include the non‐dominant hand when improvements in the dominant hand function are not possible because of trauma or stroke. This study explored whether character tracing and using a pegboard can effectively improve the handwriting of the non‐dominant hand. Methods: A randomised controlled trial involving 60 healthy university students aged ≥18 years was conducted. Participants were randomly assigned to the writing group, peg group or control group. The character recognition rate was evaluated by computer software. Furthermore, character quality and writing speed were evaluated by humans using global legibility scales. Evaluations were performed before the intervention (baseline) and on days 5 and 10 of the intervention. Using the non‐dominant hand, the writing group traced characters on paper with a ballpoint pen, and the peg group used a pegboard for 15 min/day for 10 days. Results: Compared with the peg and control groups, the writing group showed significant improvements in the character recognition rate and global legibility scale score. However, the global legibility scale score did not improve to the same level as that achieved with the dominant hand. None of the evaluation scores of the peg group showed significant improvements compared with those of the control group. There were no significant differences in improvements in the writing speed of the writing and peg groups compared with the control group. Conclusion: Tracing characters can improve the handwriting ability of the non‐dominant hand, but using a pegboard may be less effective. Future research is needed to examine how much practice is necessary to improve the handwriting ability of the non‐dominant hand sufficiently. [ABSTRACT FROM AUTHOR]

Background: Many people with aphasia have word‐finding difficulties, with some showing particular difficulties with verbs. Picture‐naming therapy is often used to improve naming, but gains are usually limited to therapy items and do not transfer to conversation. Therapy where words are produced in sentences and in real‐life activities may be more effective. Aims: The current pilot study investigated whether an activity‐oriented therapy approach would be accepted and viable if implemented in a community setting, and whether communicating whilst cooking was more beneficial than using paper‐based activities. If successful, it would be expected that verb production would improve in structured and unstructured tasks in both naming and narrative tasks. Methods & Procedures: The study employed a case‐series repeated‐measures design, with testing of treated and control items. Seven adults with anomia participated, although only five completed the full programme. Participants were divided into two groups and each group completed both treatments, but in different orders. Each treatment was employed for six 2‐h sessions over a 3‐week period. Outcomes & Results: Naming of both treated and untreated verbs showed a statistically significant improvement following both treatments and this continued into the maintenance phase. There was a numerical but not statistically significant gain in the variety of verbs used in spoken narratives. Participants predominantly chose positive terms to describe their experience of the programme, but did not prefer one therapy over the other. Conclusions & Implications: Preliminary findings suggest that an activity‐oriented therapy approach, whether it involves carrying out tasks or paper‐based activities, can result in clinically meaningful improvements for people with chronic aphasia. Further research using a randomized control trial is required to determine whether cooking therapy alone is effective. [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]

Background: Concerns about the cost and convenience of postsurgical physical therapy (PT) have sparked interest in unsupervised, home-based rehabilitation. However, the effectiveness of unsupervised home exercise after primary TKA has not been previously evaluated.Questions/purposes: (1) Can unsupervised home exercise after surgery provide noninferior recovery of passive knee flexion compared with formal outpatient PT? (2) Does a web-based platform for home-based exercise provide an advantage compared with a printed PT manual?Methods: We conducted a randomized, noninferiority trial involving 290 patients (20% of the 1464 eligible patients who could be contacted) who underwent primary TKA from March 2016 to April 2018. We included patients > 18 years old who were undergoing primary, unilateral TKA and provided written consent. We excluded patients with preoperative knee flexion < 90°, patients considering surgical intervention in a hip or the contralateral knee, patients discharged to an extended care facility, and revision or conversion TKA. We randomized patients to one of three groups: outpatient PT, unsupervised home exercise using a web-based platform (web PT), or unsupervised home exercise using a printed paper manual (paper PT). We also implemented a "delayed recovery intervention" within the home exercise program, in which patients were obliged to begin outpatient PT if knee flexion was < 70° at 2 weeks or < 90° at 4 weeks. The primary outcome was change in knee flexion from preoperative baseline after 4 to 6 weeks and 6 months. Secondary outcomes included Knee Injury and Osteoarthritis Outcome Score (KOOS), time back to activities of daily living, and time off narcotics. All analyses were intention to treat, and the noninferiority margin was 5% with maximum flexion as the outcome of interest for this parameter.Results: Adjusted differences in change in passive flexion for web PT +3° (95% confidence interval [CI], -1.2° to 6.4°) and paper PT +5° (95% CI, 0.99°-8.6°) were not inferior to outpatient PT based on a predefined 5° margin. Change in knee flexion from baseline was 0° for outpatient PT, -2° for web PT, and -1° for paper PT after 4 to 6 weeks and 8°, 8°, and 12° for the three groups, respectively, after 6 months. Additionally, there was no difference in the change in KOOS from baseline at 4 to 6 weeks or 6 months postoperatively as well as time back to work, driving, and walking without an assistive device.Conclusions: Unsupervised home exercise is an effective rehabilitation strategy after primary TKA and was noninferior to formal outpatient PT in selected patients. It is worthwhile to reconsider the current practice of automatically designating patients for outpatient PT after primary TKA, because appropriately selected patients with adequate clinical support can achieve similar results at home.Level Of Evidence: Level I, therapeutic study. [ABSTRACT FROM AUTHOR]

Introduction: Brief (≤4 sessions) behavioral treatment for insomnia (BBTi) improves insomnia symptoms in older adults. Findings for BBTi-related improvements in objective cognition are mixed, with our recent trial reporting no effects. Metacognition (appraisal of one's own performance) has not been examined. This study examined the effects of BBTi on metacognition in older adults with insomnia.Methods: Older adults with insomnia [N = 62, Mage = 69.45 (SD = 7.71)] were randomized to 4-weeks of BBTi (n = 32; psychoeducation, sleep hygiene, stimulus control, sleep restriction, relaxation, review/maintenance) or self-monitoring control (SMC; n = 30; social conversations). Throughout the study (2 week baseline, 4 week treatment, 2 week post-treament, 2 week 3-month followup), participants completed daily paper/pencil cognitive tasks (measuring verbal memory, attention, processing speed and reasoning) and provided daily metacognition ratings of their performance in four areas: quality, satisfaction, compared to same age peers, compared to own ability. Two-week averages of metacognitive ratings were calculated for baseline, treatment-first half, treatment-second half, post-treatment, and 3-month follow-up. Multilevel Modeling examined treatment effects (BBTi/SMC) over time on metacognition, controlling for age and sex.Results: A significant group by time interaction (p = 0.05) revealed consistent improvements over time in better metacognitive ratings relative to same age peers for BBTi. Specifically, baseline ratings [mean (M) = 51.21, standard error (SE) = 3.15] improved at first half of treatment (M = 56.65, SE = 3.15, p < 0.001), maintained improvement at second-half of treatment (p = 0.18), showed additional improvement at post-treatment (M = 60.79, SE = 3.15, p = 0.02), and maintained improvement at follow-up (M = 62.30, SE = 3.15; p = 0.02). SMC prompted inconsistent and smaller improvements between baseline (M = 53.24, SE = 3.29) and first-half of treatment (M = 56.62, SE = 3.28; p = 0.004), with additional improvement at second-half of treatment (M = 59.39, SE = 3.28; p = 0.02) that was maintained at post-treatment (p = 0.73) and returned to levels observed at first-half of treatment (M = 57.78, SE = 3.21; p = 0.55). Significant main effects of time (all ps < 0.001) for other metacognition variables (Quality, Satisfaction, Compared to own ability) indicated general improvements over time for both groups.Discussion: Metacognition generally improved over time regardless of treatment. BBTi selectively improved ratings of performance relative to same age peers. Repeated objective testing alone may improve metacognition in older adults with insomnia. Better understanding of metacognition and how to improve it has important implications for older adults as metacognitive complaints have been associated with mild cognitive impairment. [ABSTRACT FROM AUTHOR]

Objective: The study aimed to determine the effect of motivational interviewing on the change of breast cancer screening behaviors among rural Iranian women.Methods: This Randomized controlled trial (RCT) was performed on 120 Iranian rural women selected through cluster random sampling method. Out of all 20 rural health centers of Abish Ahmad District, in the northwest of Iran, about one third (six clusters) were randomly selected; out of which three were randomly assigned to the control group and three to the intervention group. A list of women aged 40-69 years in the selective health centers was prepared and 60 participants were selected for each group through the convenience sampling method based on the inclusion and exclusion criteria. Then, six group sessions (two educational and four motivational interviewing sessions) were held for the intervention group. The data were collected using demographic and obstetric questionnaire, paper-based health records, and the stages of change checklist and analyzed in SPSS 24. The groups were compared through the chi square test, homogeneity test, and the sequential logistic regression with generalized estimating equations.Results: Two months after the intervention, a significant difference was found between the two groups in terms of the stages of change for clinical breast examination and mammography by taking into account the pre-intervention stages (p = 0.001).Conclusion: MI-based counseling increased the Iranian rural women's motivation for displaying breast cancer screening behaviors.Practice Implications: The application of MI for enhancing cancer screening programs among Iranian women is suggested. [ABSTRACT FROM AUTHOR]

Introduction: This study examines the feasibility and effectiveness of an intensive lifestyle intervention adapted for people with impaired mobility.Study Design: This was a randomized, wait-list controlled trial. The experimental group immediately received the 12-month weight loss program; the wait-list control group received it after a 6-month delay. Between-group comparisons were conducted for the 6-month RCT study design. Repeated measures were conducted for both groups combined after receiving the 12-month intervention. Data were collected August 2015-February 2017 and analyzed in 2017.Setting/participants: A community-based sample received 23, group-based sessions via a mix of telephone and in-person sessions in a hospital-based setting. Participants with impaired mobility (n=66) were middle-aged (49.80 [SD=11.37] years), mostly White (66.7%), female (66.7%), and most commonly had spinal cord injury (47.0%).Intervention: The 12-month intervention delivered 23 group-based sessions that promoted weight loss through reducing caloric intake and increasing physical activity.Main Outcome Measures: Primary outcomes were effectiveness measured as change in weight and time spent in moderate physical activity. Feasibility was assessed in 12-month combined group analyses, measured as retention, attendance, and dietary self-monitoring.Results: The 6-month RCT results showed that the immediate and delayed groups differed significantly (p<0.05) in weight (-1.66 [SD=4.42] kg loss vs 0.05 [SD=4.15] kg gain) and moderate physical activity (52.93 [SD=90.74] minutes/week increase vs -14.22 [SD=96.02] minutes/week decrease), accounting for baseline weight, time with disability, and age of onset. The 12-month results with groups combined demonstrated 74.2% retention and 77.7% core session attendance. Self-monitoring was higher in the delayed group (77.3%), who used a smartphone app, than the immediate group (47.3%), who mostly used paper trackers. Participants achieved significant 12-month weight loss of 3.31 (SD=10.13) kg (d=0.33) in mixed modeling analyses with groups combined yet did not significantly increase moderate physical activity.Conclusions: Group Lifestyle Balance Adapted for Individuals with Impaired Mobility is a feasible, effective approach to teach healthy lifestyle skills to individuals with mobility impairment, yielding modest weight loss and enhanced self-efficacy.Trial Registration: This study is registered at www.clinicaltrials.gov NCT03307187. [ABSTRACT FROM AUTHOR]

Aim: To examine the efficacy of Hand-Arm Bimanual Intensive Therapy (HABIT) on daily functioning, unimanual dexterity, and bimanual performance of children with bilateral cerebral palsy (CP) compared with customary care.Method: Forty-one children with bilateral CP, aged 4 to 16 years, classified in levels I to III of the Manual Ability Classification System, were randomly assigned to HABIT (90h) (n=21) or to customary care (4.5h) (n=20). Participants' daily functioning (Pediatric Evaluation of Disability Inventory [PEDI], Canadian Occupational Performance Measure [COPM]), unimanual dexterity (Jebsen-Taylor Test of Hand Function, Box and Blocks Test [BBT]), and bimanual performance (Both Hands Assessment) were assessed pre-, post-, and 6 months after the intervention. Linear mixed-effects models were used for inferential analysis.Results: Children participating in HABIT showed greater improvements in daily functioning (COPMperformance : χ12 =9.50, p<0.01; COPMsatisfaction : χ12 =5.07, p<0.05; PEDIfunctional skills : χ12 =6.81, p<0.01; PEDIcaregiver assistance : χ12 =6.23, p<0.05) and in the dexterity of the dominant hand (BBT: χ12 =3.99, p<0.05) compared with children maintaining customary care. Group or time effects did not explain any variance in bimanual performance or in the dexterity of the non-dominant hand.Interpretation: HABIT may be beneficial for children with bilateral CP, with benefits evidenced for daily functioning outcomes.What This Paper Adds: Hand-Arm Bimanual Intensive Therapy (HABIT) improved daily functioning of children with bilateral cerebral palsy (CP). Bimanual performance, measured by the Both Hands Assessment, did not change after HABIT in children with bilateral CP. Children with asymmetric and symmetric hand use exhibited similar improvements after HABIT. [ABSTRACT FROM AUTHOR]

Aim: To investigate the efficacy of waiting room media for reducing anxiety and increasing satisfaction at a paediatric rehabilitation hospital.Method: In this clustered, parallel, randomized controlled trial, 310 young people with disabilities (age range 5-19y) and their parents attending outpatient clinics were assigned to interactive media (n=113), a silent nature video (n=97), or media-free comparison (n=100) groups. Young person and parent anxiety was reported using the State-Trait Anxiety Inventory (STAI) on arrival and after 10 minutes in the waiting space. Questionnaires measured young person, parent, and staff satisfaction.Results: Young people exposed to interactive media reported a postexposure state anxiety that was 1.1 raw points (2.7 standardized points) lower on the STAI than the comparison group (95% confidence interval [CI] -1.9 to -0.22). There was no difference in postexposure state anxiety between the passive media and comparison groups (95% CI -0.64 to 1.1). Parents' state anxiety did not differ between conditions, but interactive media were associated with greater satisfaction (p=0.009). Of 120 staff, 119 reported that interactive media improved the clinic experience for families.Interpretation: Interactive media designed for accessible, hands-free play mitigate waiting anxiety and increases satisfaction. This paper provides evidence to guide design and decision-making around the use of interactive media in health care spaces.What This Paper Adds: Interactive media reduced preclinic waiting anxiety for young people with disabilities. Interactive media were accessible to young people with a range of mobility. Interactive media increased parental and staff satisfaction in the clinic. Guidelines for the design of hands-free, inclusive interactive media for health care facilities are presented. [ABSTRACT FROM AUTHOR]

This paper presents findings from a multi-centre, double-blind, randomized controlled trial that tested the hypothesis that parent and youth mental health improvements would be superior in a family-based intervention for adolescent depression (BEST MOOD) compared to a treatment-as-usual supportive parenting program (PAST). Eligible participants were families with a young person aged between 12 and 18 years who met diagnostic criteria for a depressive disorder (major, minor or dysthymic). Participating families (N = 64; 73.4% of youth were female) were recruited in Victoria, Australia and allocated to treatment condition using a block randomization procedure (parallel design) with two levels of blinding. This paper reports on the trial's secondary outcomes on youth and parent mental health. General linear mixed models were used to examine the longitudinal effect of treatment group on outcome. Data were analyzed according to intention-to-treat; 31 families were analyzed in BEST MOOD, and 33 families in PAST. Parents in the BEST MOOD group experienced significantly greater reductions in stress and depressive symptoms than parents in the PAST group at 3-month follow-up. A greater reduction in parental anxiety was observed in the BEST MOOD group (d = 0.35) compared with PAST (d = 0.02), although the between-group difference was not significant. Both groups of youth showed similar levels of improvement in depressive symptoms at post-treatment (d = 0.83 and 0.80 respectively), which were largely sustained at a 3-month follow-up. The family-based BEST MOOD intervention appeared superior to treatment-as-usual (PAST) in demonstrating greater reductions in parental stress and depression. Both interventions produced large reductions in youth depressive symptoms. [ABSTRACT FROM AUTHOR]

The ECG Belt for CRT response trial is designed to test the hypothesis that in patients traditionally less likely to respond to cardiac resynchronization therapy (CRT), an individualized approach utilizing the electrocardiogram (ECG) Belt to guide lead placement, vector selection, and device programming is superior to current standard of care. The ECG Belt is a noninvasive mapping technology designed to measure beat by beat electrical activation of the left ventricle by utilizing unipolar measurements from multiple ECG electrodes on the body surface. The ECG Belt for CRT response trial is a multicenter, prospective, randomized, investigational pre‐market research study conducted at 48 centers in the United States, Canada, and Europe and will randomize approximately 400 subjects. The trial has three arms (enrollment will be 2:1:1, respectively): utilization of the Belt to guide implant as well as postimplant programming, utilizing the Belt to guide postimplant programming alone, and a non‐Belt control arm. AdaptivCRT will be an option in the treatment arm but not the control arms. The primary endpoint is change in left ventricular end‐systolic volume between preimplant and at 6 months. This paper describes the design and analytic plan for the trial. [ABSTRACT FROM AUTHOR]

We investigated the effects of readymade versus self‐generated graphic organizers (GOs) on learning, comparing the performances of undergraduates (N = 81) tasked with learning a multimedia document. This document was either presented on its own (control group), with a readymade GO, or with a blank GO that students had to fill in either before or during the learning of the document. In line with previous research, adding a readymade GO increased students' memorization and transfer scores, compared with controls. By displaying the main ideas in the text and their hierarchical relations, GOs act as visual aids to learning. Results showed that self‐generating a GO was no more beneficial than viewing a readymade GO when students were placed in a dual‐task situation (generation + learning). However, when the students' information processing was guided by sequencing these tasks (generation then learning), they outperformed the control and readymade groups on memorization and comprehension. Lay Description: What is already known about this topic: Graphic organizers (GOs) consist in visual displays showing the main ideas of a text and their interrelations.Adding GOs to pedagogical document have been shown to improve students' learning.However, self‐generating GOs has been proven to be detrimental for learning in several studies. What this paper adds: In previous studies, self‐generation of graphic organizers (GOs) have often been carried out while learning, however this task should be separated from the learning task.In the present study, students' learning performances increased when the self‐generated task was separated from the learning task compared to a condition with a readymade GO.These benefits on learning were not observed when the self‐generated activity was not guided. Implications for practitioners: Graphic organizers gathering all the key elements of a multimedia document and highlighting the structure of this document should be used in order to increase students' learning.Students should not be placed in double‐task situation when learning from a pedagogical document.In‐task guidance should be provided when self‐generative tasks are performed. [ABSTRACT FROM AUTHOR]

Objective: To determine the effect of nutrition education program on hemodialysis patients' quality of life (QoL) and serum electrolytes levels.Methods: This study was a randomized controlled trial in which 94 eligible hemodialysis patients were randomly assigned to intervention (n = 48) and control (n = 46) groups. In the intervention group, the patients were trained in healthy nutrition for four weeks. After two months, samples of both groups completed the Kidney Disease Quality of Life Instrument (KDQOL) and Na, K, P, Ca and Mg levels were also measured and compared.Results: There were no significant differences in QoL scores and electrolytes between the two groups before intervention (p > 0.05). After intervention the QoL scores in the intervention group were significantly higher than in the control group (p < 0.05). However, after intervention the levels of Na, K, P and Mg in the intervention group were significantly lower than in the control group (p < 0.05). Calcium level was not significantly different between the two groups after intervention (p = 0.16).Conclusion: The results showed that e-learning is effective in improving the QoL and serum electrolytes of hemodialysis patients.Practice Implications: This paper could serve as support for clinical healthcare professionals to improve patient knowledge and QoL through virtual education methods. [ABSTRACT FROM AUTHOR]

Child birth order (CBO) in the family has received little attention in the field of prevention science. CBO is relevant to early interventionists from a public health perspective, as the most widely disseminated home-visiting program has traditionally targeted mothers and their first-born children. The current paper revisits a previous publication by Shaw et al. (2009) on the effectiveness of the Family Check-Up (FCU) to evaluate CBO (firstborn vs. middle vs. youngest) as a moderator of treatment effects of the FCU in relation to improvements in parenting, maternal depressive symptoms, and child outcomes from ages 2 to 4 in a sample of low-income, ethnically diverse families (N = 709) with multiple children. Results suggest that the FCU elicited improvements in observed parenting from ages 2 to 3 primarily for target children who were the youngest or middle children, but not for firstborns. Findings are discussed in the context of implications for prevention science research, dissemination, and public policy. [ABSTRACT FROM AUTHOR]

Aims: The TTM2-trial is a multi-centre randomised clinical trial where targeted temperature management (TTM) at 33 °C will be compared with normothermia and early treatment of fever (≥37.8 °C) after Out-of-Hospital Cardiac Arrest (OHCA). This paper presents the design and rationale of the TTM2-trial follow-up, where information on secondary and exploratory outcomes will be collected. We also present the explorative outcome analyses which will focus on neurocognitive function and societal participation in OHCA-survivors.Methods: Blinded outcome-assessors will perform follow-up at 30-days after the OHCA with a telephone interview, including the modified Rankin Scale (mRS) and the Glasgow Outcome Scale Extended (GOSE). Face-to-face meetings will be performed at 6 and 24-months, and include reports on outcome from several sources of information: clinician-reported: mRS, GOSE; patient-reported: EuroQol-5 Dimensions-5 Level responses version (EQ-5D-5L), Life satisfaction, Two Simple Questions; observer-reported: Informant Questionnaire on Cognitive Decline in the Elderly-Cardiac Arrest version (IQCODE-CA) and neurocognitive performance measures: Montreal Cognitive Assessment, (MoCA), Symbol Digit Modalities Test (SDMT). Exploratory analyses will be performed with an emphasis on brain injury in the survivors, where the two intervention groups will be compared for potential differences in neuro-cognitive function (MoCA, SDMT) and societal participation (GOSE). Strategies to increase inter-rater reliability and decrease missing data are described.Discussion: The TTM2-trial follow-up is a pragmatic yet detailed pre-planned and standardised assessment of patient's outcome designed to ensure data-quality, decrease missing data and provide optimal conditions to investigate clinically relevant effects of TTM, including OHCA-survivors' neurocognitive function and societal participation. [ABSTRACT FROM AUTHOR]

Aim: To test the hypothesis that improvements in gait and function following individualized interdisciplinary interventions consisting of physical therapy, orthotics, spasticity management, and orthopaedic surgery using instrumented gait analysis are superior to 'usual care' in children with cerebral palsy (CP).Method: This was a prospective, single-blind, parallel-group, randomized controlled trial investigating the effectiveness of interventions based on the use of gait analysis. Primary outcome was gait (Gait Deviation Index) and secondary outcomes were walking and patient-reported outcome measures of function, disability, and health-related quality of life. Follow-ups were done at 26 weeks (questionnaires) and at the primary end point of 52 weeks (all outcomes).Results: Sixty participants with CP (39 males, 21 females, mean age 6y 10mo, standard deviation 1y 3mo, range 5y-9y 1mo) in Gross Motor Function Classification System levels I or II, were randomized to interventions with or without gait analysis. No significant or clinically relevant between-group differences in change scores of the primary or secondary outcomes were found. The recommended categories of interventions were dominated by non-surgical interventions and were applied in 36% to 86% of the participants.Interpretation: Interventions using gait analysis were not superior to 'usual care' on gait, walking, or patient-reported outcomes in a sample of relatively young and independently walking children with CP not expected to need surgery.What This Paper Adds: Gait analysis in children with cerebral palsy in Gross Motor Function Classification System levels I or II recommends interdisciplinary interventions. Compliance to interventions recommended after gait analysis was low. No statistically significant advantages were identified for the intervention group versus the control group. [ABSTRACT FROM AUTHOR]

Background: Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time. Previous studies have shown that a personal safety plan can assist in providing support, when a person experiences suicide ideation, and help seeking professional assistance if needed. The aim of the trial is to determine whether a newly developed safety mobile app is more effective in reducing suicide ideation and other symptoms, compared to a safety plan on paper.Methods/design: The trial is designed as a two-arm, observer-blinded, parallel-group randomized clinical superiority trial, where participants will either receive: (1) Experimental intervention: the safety plan provided as the app MyPlan, or (2) Treatment as Usual: the safety plan in the original paper format. Based on a power calculation, a total of 546 participants, 273 in each arm will be included. They will be recruited from Danish Suicide Prevention Clinics. Both groups will receive standard psychosocial therapeutic care, up to 8-10 sessions of supportive psychotherapy. Primary outcome will be reduction in suicide ideation after 12 months. Follow-up interviews will be conducted at 3, 6, 9, and 12 months after date of inclusion.Discussion: A safety plan is a mandatory part of the treatment in the Suicide Prevention Clinics in Demark. There are no studies investigating the effectiveness of a safety plan app compared to a safety plan on paper on reducing suicide ideation in patients with suicide ideation and suicidal behavior. The trial will gain new knowledge of whether modern technology can augment the effects of traditional personalized safety planning.Trial Registration: ClinicalTrials.gov, NCT02877316 . Registered on 19 August 2016. [ABSTRACT FROM AUTHOR]

Background: Little is known about the influence of practice schedules on motor learning and skills transfer in children with and without developmental coordination disorder (DCD). Understanding how practice schedules affect motor learning is necessary for motor skills development and rehabilitation.Aims: The study investigated whether active video games (exergames) training delivered under variable practice led to better learning and transfer than repetitive practice.Methods and Procedures: 111 children aged 6-10 years (M=8.0, SD=1.0) with no active exergaming experience were randomized to receive exergames training delivered under variable (Variable Game Group (VGG), n=56) or repetitive practice schedule (Repetitive Game Group (RGG), n=55). Half the participants were identified as DCD using the DSM-5 criteria, while the rest were typically developing (TD), age-matched children. Both groups participated in two 20min sessions per week for 5 weeks.Outcomes and Results: Both participant groups (TD and DCD) improved equally well on game performance. There was no significant difference in positive transfer to balance tasks between practice schedules (Repetitive and Variable) and participant groups (TD and DCD).Conclusions and Implications: Children with and without DCD learn balance skills quite well when exposed to exergames. Gains in learning and transfer are similar regardless of the form of practice schedule employed.What This Paper Adds: This is the first paper to compare the effect of practice schedules on learning in children with DCD and those with typical development. No differences in motor learning were found between repetitive and variable practice schedules. When children with and without DCD spend the same amount of time on exergames, they do not show any differences in acquisition of motor skills. Transfer of motor skills is similar in children with and without DCD regardless of differences in practice schedules. [ABSTRACT FROM AUTHOR]

Background: Medication dispensing errors are common in clinical trials, and have a significant impact on the quality and validity of a trial. Therefore, the definition, calculation and evaluation of such errors are important for supporting a trial's conclusions. A variety of medication dispensing errors can occur. In this paper, we focus on errors in trials where the intervention includes multiple therapies that must be given in a pre-specified order that varies across treatment arms and varies in duration.Methods: The Pragmatic, Randomized Optimal Platelet and Plasma Ratios (PROPPR) trial was a Phase III multi-site, randomized trial to compare the effectiveness and safety of 1:1:1 transfusion ratios of plasma and platelets to red blood cells with a 1:1:2 ratio. In this trial, these three types of blood products were to be transfused in a pre-defined order that differed by treatment arm. In this paper, we present approaches from the PROPPR trial that we used to define and calculate the occurrence of out of order blood transfusion errors. We applied the proposed method to calculate protocol adherence to the specified order of transfusion in each treatment arm.Results: Using our proposed method, protocol adherence was greater in the 1:1:1 group than in the 1:1:2 group (96% vs 93%) (p<0.0001), although out of order transfusion errors in both groups were low. Final transfusion ratios of plasma to platelets to red blood cells for the 1:1:1 ratio group was 0.93:1.32:1, while the transfusion ratio for the 1:1:2 ratio group was 0.48:0.48:1.Conclusions: Overall, PROPPR adherence to blood transfusion order pre-specified in the protocol was high, and the required order of transfusions for the 1:1:2 group was more difficult to achieve. The approaches proposed in this manuscript were useful in evaluating the PROPPR adherence and are potentially useful for other trials where a specific treatment orders with varying durations must be maintained. [ABSTRACT FROM AUTHOR]

Background: In the last few decades, the number of trials using Bayesian methods has grown rapidly. Publications prior to 1990 included only three clinical trials that used Bayesian methods, but that number quickly jumped to 19 in the 1990s and to 99 from 2000 to 2012. While this literature provides many examples of Bayesian Adaptive Designs (BAD), none of the papers that are available walks the reader through the detailed process of conducting a BAD. This paper fills that gap by describing the BAD process used for one comparative effectiveness trial (Patient Assisted Intervention for Neuropathy: Comparison of Treatment in Real Life Situations) that can be generalized for use by others. A BAD was chosen with efficiency in mind. Response-adaptive randomization allows the potential for substantially smaller sample sizes, and can provide faster conclusions about which treatment or treatments are most effective. An Internet-based electronic data capture tool, which features a randomization module, facilitated data capture across study sites and an in-house computation software program was developed to implement the response-adaptive randomization.Results: A process for adapting randomization with minimal interruption to study sites was developed. A new randomization table can be generated quickly and can be seamlessly integrated in the data capture tool with minimal interruption to study sites.Conclusion: This manuscript is the first to detail the technical process used to evaluate a multisite comparative effectiveness trial using adaptive randomization. An important opportunity for the application of Bayesian trials is in comparative effectiveness trials. The specific case study presented in this paper can be used as a model for conducting future clinical trials using a combination of statistical software and a web-based application.Trial Registration: ClinicalTrials.gov Identifier: NCT02260388 , registered on 6 October 2014. [ABSTRACT FROM AUTHOR]

Intravaginal rings (IVRs) are an established option for continuous administration of drugs in women. The combination of anastrozole (ATZ) and levonorgestrel (LNG) in an IVR with an intended 4‐week wearing period has been considered for long‐term treatment of endometriosis‐associated pelvic pain. A randomized, parallel‐group, multicenter phase 2b study to assess the efficacy and safety of different dose combinations in women with symptomatic endometriosis has recently been performed. This paper will focus on the investigation of pharmacokinetic (PK) effects of ATZ on LNG using data collected from this study. Two hundred sixteen patients were randomized to the treatment group with IVRs releasing LNG 40 μg/day alone or in combination with ATZ 300 μg/day, 600 μg/day, or 1050 μg/day for 12 weeks. PK blood samples were taken before dosing and before IVR replacement or removal (days 28, 56, and 84). The primary PK parameter was the plasma concentration in apparent steady state of ATZ and LNG at the end of each IVR wearing period. Results of PK analysis demonstrate that ATZ concentrations increased proportionally with increasing dose (geometric mean values of 7.85, 15.48, and 22.61 μg/L at 300, 600, and 1050 μg/day nominal release, respectively). All point estimates for LNG concentration in apparent steady state ratios between the mono and combination IVR groups were close to 1, and the 90% confidence interval limits were in the 0.80 to 1.25 range (1.01 [0.85‐1.19], 1.03 [0.88‐1.20], 0.94 [0.80‐1.10]). In conclusion, our data indicate there is no evidence of drug‐drug interaction of ATZ on LNG. [ABSTRACT FROM AUTHOR]

Objective: This study evaluated the efficacy of a smartphone-based, patient-centered diabetes care system (mDiabetes) for type 2 diabetes that contains comprehensive modules for glucose monitoring, diet, physical activity, and a clinical decision support system.Research Design and Methods: We conducted a 24-week, multicenter, randomized controlled trial with adult patients with inadequately controlled type 2 diabetes. The patients were randomly assigned to the mDiabetes group or the paper logbook (pLogbook) group. The primary end point was the difference of the change in HbA1c from baseline between the two groups.Results: HbA1c reduction from baseline was greater in the mDiabetes group (-0.40 ± 0.09%, n = 90) than in the pLogbook group (-0.06 ± 0.10%, n = 82). The difference of adjusted mean changes was 0.35% (95% CI 0.14-0.55, P = 0.001). The proportion of patients whose HbA1c fell below 7.0% (53 mmol/mol) was 41.1% for the mDiabetes group and 20.7% for the pLogbook group (odds ratio [OR] 2.01, 95% CI 1.24-3.25, P = 0.003). The percentage of patients who attained HbA1c levels below 7.0% (53 mmol/mol) without hypoglycemia was 31.1% in the mDiabetes group and 17.1% in the pLogbook group (OR 1.82, 95% CI 1.03-3.21, P = 0.024). There was no difference in the event numbers of severe hyperglycemia and hypoglycemia between the two groups.Conclusions: The implementation of the mDiabetes for patients with inadequately controlled type 2 diabetes resulted in a significant reduction in HbA1c levels, with tolerable safety profiles. [ABSTRACT FROM AUTHOR]

Purpose: Eczema is a pediatric skin disease that affects the psychosocial well-being of both children and their parent caregivers. This paper outlines a protocol for an experimental study that evaluates the effectiveness of a psychosocial empowerment program for children with eczema and their parent caregivers. Method: A multi-center randomized controlled trial is proposed, where parent–child dyads are randomized into two arms: an intervention group and wait-list control group. The intervention is delivered to participants in a parallel group format based on the Integrative Body-Mind-Spirit model which focuses on holistic well-being. Quality of life is measured before and after the intervention is provided, and five weeks after the intervention has been completed. Discussion: The suggested model fills a research gap in existing interventions, and provides new knowledge by evaluating the effectiveness of a tailored psychosocial intervention, delivered in group settings, for parent–child dyads affected by eczema. [ABSTRACT FROM AUTHOR]

Aim: To investigate whether neonates at risk for neurodevelopmental impairment have improved neurodevelopment after docosahexaenoic acid, choline, and uridine-5-monophosphate supplementation versus controls.Method: Recruitment was from UK neonatal units. Eligible for inclusion were infants born at less than 31 weeks' gestation with a weight less than the ninth centile; infants born at less than 31 weeks' gestation with a grade II or higher intraventricular haemorrhage/preterm white matter injury; infants born between 31 weeks' and 40 weeks' gestation plus 28 days with a grade II or higher intraventricular haemorrhage/preterm white matter injury, moderate or severe hypoxic-ischaemic encephalopathy, or defined neuroimaging abnormalities. Treatment/control supplementation was for 2 years (double-blind, randomized, controlled design). Infants were stratified according to sex, gestation, and brain injury severity. Primary outcome was cognitive composite score (CCS) of the Bayley Scales of Infant Development, Third Edition (Bayley-III at 24mo). Secondary outcomes were language composite score (LCS) of the Bayley-III, motor composite score (MCS) of the Bayley-III, and Vineland Adaptive Behaviour Scales, Second Edition (VABS-II) score.Results: Sixty-two neonates were recruited, 59 were randomized (34 males, 25 females). Fifty-three started supplementation. Most families found supplementation acceptable. The treatment group CCS-Bayley-III scores were non-significantly higher than controls (mean score difference at 24mo: 9.0; 95% confidence interval -0.2 to 18.2). Language and VABS-II scores, but not motor score, were non-significantly higher in the treatment group.Interpretation: Most families found supplementation feasible. Improved neurodevelopmental outcomes in the treatment group were not statistically significant. A larger multicentre trial exploration is warranted.What This Paper Adds: Dietary supplementation of neonates at risk of neurodevelopmental impairment is feasible. No statistically significant neurodevelopmental advantages were identified for the treatment group compared to controls. Treatment group cognitive and language advantage are of a clinically meaningful magnitude. [ABSTRACT FROM AUTHOR]

Aim: To investigate whether docosahexaenoic acid (DHA), choline, and uridine-5-monophosphate (UMP) supplementation improves neurodevelopmental outcome in infants with suspected cerebral palsy (CP) versus a comparison group of children.Method: Infants aged 1 to 18 months with suspected CP were recruited from UK child development centres. Participants received daily treatment or control supplementation for 2 years (double-blind randomized control design). Stratification was by age, sex, predominant pattern of motor involvement (four limbs or other), and visual impairment (or not). The primary outcome was the cognitive composite score of the Bayley Scales of Infant and Toddler Development, Third Edition (CCS-Bayley-III). Secondary outcomes included language composite and motor composite scores of the Bayley Scales of Infant and Toddler Development, Third Edition (Bayley-III).Results: Forty infants were recruited; 35 began supplementation, 29 completed 1 to 2 years' supplementation. The treatment group CCS-Bayley-III was non-significantly higher than the comparison group (mean 77.7 [SD 19.2] and 72.2 [SD 19.8] respectively, mean modelled difference 4.4 [-2.8, 11.6]). The treatment group language scores, but not motor scores, were non-significantly higher than for the comparison group.Interpretation: Most families found supplementation feasible. No statistically significant differences in neurodevelopmental outcome between the treatment and comparison groups were identified. Further investigation of neurodevelopmental outcome after supplementation with DHA, choline, and UMP of infants with suspected CP is warranted.What This Paper Adds: This was the first trial of phosphatidylcholine precursor supplementation in infants with suspected cerebral palsy (CP). Families of infants with suspected CP found 2-year nutritional supplementation feasible. There was no statistically significant neurodevelopmental advantage for the treatment group versus the comparison group. However, treatment group cognitive and language advantage were of clinically meaningful magnitude. [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]

Background: Continuity of care by a primary midwife during the antenatal, intrapartum and postpartum periods has been recommended in Australia and many hospitals have introduced a caseload midwifery model of care. The aim of this paper is to evaluate the effect of caseload midwifery on women's satisfaction with care across the maternity continuum.Methods: Pregnant women at low risk of complications, booking for care at a tertiary hospital in Melbourne, Australia, were recruited to a randomised controlled trial between September 2007 and June 2010. Women were randomised to caseload midwifery or standard care. The caseload model included antenatal, intrapartum and postpartum care from a primary midwife with back-up provided by another known midwife when necessary. Women allocated to standard care received midwife-led care with varying levels of continuity, junior obstetric care, or community-based general practitioner care. Data for this paper were collected by background questionnaire prior to randomisation and a follow-up questionnaire sent at two months postpartum. The primary analysis was by intention to treat. A secondary analysis explored the effect of intrapartum continuity of carer on overall satisfaction rating.Results: Two thousand, three hundred fourteen women were randomised: 1,156 to caseload care and 1,158 to standard care. The response rate to the two month survey was 88% in the caseload group and 74% in the standard care group. Compared with standard care, caseload care was associated with higher overall ratings of satisfaction with antenatal care (OR 3.35; 95% CI 2.79, 4.03), intrapartum care (OR 2.14; 95% CI 1.78, 2.57), hospital postpartum care (OR 1.56, 95% CI 1.32, 1.85) and home-based postpartum care (OR 3.19; 95% CI 2.64, 3.85).Conclusion: For women at low risk of medical complications, caseload midwifery increases women's satisfaction with antenatal, intrapartum and postpartum care.Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN012607000073404 (registration complete 23rd January 2007). [ABSTRACT FROM AUTHOR]

Background: Exposure to sunlight can have both positive and negative health impacts. Excessive exposure to ultra-violet (UV) radiation from the sun can cause skin cancer, however insufficient exposure to sunlight has a detrimental effect on production of Vitamin D. In the construction industry there are onsite proactive behaviours for safety, but sun-safety remains a low priority. There is limited research on understanding the barriers to adopting sun-safe behaviours and the association this may have with Vitamin D production. This paper reports a protocol for an intervention study, using text messaging in combination with a supportive smartphone App. The intervention aims to both reduce UV exposure during months with higher UV levels and promote appropriate dietary changes to boost Vitamin D levels during months with low UV levels.Method/design: Approximately 60 construction workers will be recruited across the United Kingdom. A randomised control crossover trial (RCCT) will be used to test the intervention, with randomisation at site level - i.e. participants will receive both the control (no text messages or supportive App support) and intervention (daily text messages and supportive App). Using the Theory of Planned Behaviour (TPB) the intervention focuses on supporting sun-safety and healthy dietary decisions in relation to Vitamin D intake. The intervention emphasises cultivating the perception of normative support in the workplace, increasing awareness of control and self-efficacy in taking sun-protective behaviours, making healthier eating choices to boost Vitamin D, and tackling stigmas attached to image and group norms. Each study epoch will last 21 days with intervention text messages delivered on workdays only. The supportive App will provide supplementary information about sun protective behaviours and healthy dietary choices. The primary outcome measure is 25-hydroxy-Vitamin D [25(OH)D] level (obtained using blood spot sampling), which will be taken pre and post control and intervention periods. Secondary outcome measures are two-fold, (1) using the TPB to detect changes in behaviour, and (2) quantifying UV exposure during the UK peak radiation season (April-September) using body-mounted UV sensors.Discussion: This study will provide important information about the effectiveness of a technology-based intervention to promote sun-safety and healthy behaviours in outdoor construction workers.Trial Registration: ISRCTN15888934 retrospectively registered 15.01.2018. [ABSTRACT FROM AUTHOR]

Background: Type 2 diabetes mellitus is associated with cognitive dysfunction and an increased risk of dementia. Linagliptin is a glucose-lowering agent of the dipeptidyl peptidase-IV (DPP-IV) inhibitor class that is of particular interest for the prevention of accelerated cognitive decline, because it may potentially benefit the brain through pleiotropic effects, beyond glucose lowering. This paper presents the design of a study that aims to establish if linagliptin is superior to the sulfonylurea glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus.Methods: The cognition substudy is an integral part of the ongoing event-driven, randomised, double blind CARdiOvascular safety of LINAgliptin (CAROLINA®) trial, which evaluates the effect of treatment with linagliptin versus glimepiride on cardiovascular outcomes. CAROLINA® includes patients with type 2 diabetes mellitus with sub-optimal glycaemic control at elevated cardiovascular risk. The substudy will evaluate patients randomised and treated who have a baseline Mini Mental State Examination (MMSE) score ≥ 24, documented years of formal education with at least one valid cognitive assessment at baseline and during follow-up. The primary cognitive outcome is the occurrence of accelerated cognitive decline at the end of follow-up. The two treatment groups will be compared by using a logistic regression. Accelerated cognitive decline is defined as a rate of cognitive decline that falls at or below the 16th percentile of decline for the whole cohort on either the MMSE or a combined score of the trail making and verbal fluency test. Potential confounders are taken into account at an individual patient level, using a regression based index.Discussion: Between December 2010 and December 2012, 6042 patients were randomised and treated with either linagliptin (5 mg) or glimepiride (1-4 mg) once daily in CAROLINA®. Cognitive tests were conducted in nearly 4500 participants at baseline and are scheduled for two subsequent assessments, after 160 weeks of follow-up and end of follow-up. This substudy of the ongoing CAROLINA® trial will establish if linagliptin is superior to glimepiride in the prevention of accelerated cognitive decline in patients with type 2 diabetes mellitus. Final results are expected in 2019.Trial Registration: ClinicalTrials.gov Identifier: NCT 01243424 . [ABSTRACT FROM AUTHOR]

Active learning combines academic content with physical activity (PA) to increase child PA and academic performance, but the impact of active learning is mixed. It may be that this is a moderated relationship in which active learning is beneficial for only some children. This paper examine the impact of baseline academic performance and gender as moderators for the effects of active learning on children's academic performance. In the ASK-study, 1129 fifth-graders from 57 Norwegian elementary schools were randomized by school to intervention or control in a physical activity intervention between November 2014 and June 2015. Academic performance in numeracy, reading, and English was measured and a composite score was calculated. Children were split into low, middle and high academic performing tertiles. 3-way-interactions for group (intervention, control)∗gender (boys, girls)∗academic performance (tertiles) were investigated using mixed model regression. There was a significant, 3-way-interaction (p=0.044). Both boys (ES=0.11) and girls (ES=0.18) in the low performing tertile had a similar beneficial trend. In contrast, middle (ES=0.03) and high performing boys (ES=0.09) responded with small beneficial trends, while middle (ES=-0.11) and high performing girls (ES=-0.06) responded with negative trends. ASK was associated with a significant increase in academic performance for low performing children. It is likely that active learning benefited children most in need of adapted education but it may have a null or negative effect for those girls who are already performing well in the sedentary classroom. Differences in gendered responses are discussed as a possible explanation for these results.Trial Registration: Clinicaltrials.gov registry, trial registration number: NCT02132494. [ABSTRACT FROM AUTHOR]

Aim: To examine the differential effects of an early intervention programme for infants born preterm on neurodevelopment and parental mental health according to family social risk.Method: One hundred and twenty infants born earlier than 30 weeks' gestation were randomized to early intervention (n=61) or control groups (n=59). Cognitive, language, and motor outcomes were assessed by blinded assessors at 2 years, 4 years, and 8 years, and primary caregivers completed questionnaires on their anxiety and depression. Outcomes at each time point were compared between groups using linear regression with an interaction term for social risk (higher/lower).Results: There was evidence of interactions between intervention group and social risk for cognition at 2 years and 4 years, motor function at 4 years, and language at 8 years, with a greater intervention effect in children from higher social risk environments. In contrast, the impact of early intervention on parental depressive symptoms was greater for parents of lower social risk than for those of higher social risk.Interpretation: Effects of early intervention on outcomes for children born preterm and their caregivers varied according to family social risk. Family social risk should be considered when implementing early intervention programmes for children born preterm and their families.What This Paper Adds: Intervention is associated with better early cognitive functioning for children in higher social risk families. Positive effects of intervention for the high risk group were not sustained at school-age. Intervention has a greater effect on primary caregiver mental health in the lower social risk group compared with higher social risk. [ABSTRACT FROM AUTHOR]

Background: The Healthy Lifestyles Programme (HeLP) was a novel school-located intervention for 9-10 year olds, designed to prevent obesity by changing patterns of child behaviour through the creation of supportive school and home environments using dynamic and creative delivery methods. This paper reports on both the quantitative and qualitative data regarding the implementation of the HeLP intervention in the definitive cluster randomised controlled trial, which was part of the wider process evaluation. Methods: Mixed methods were used to collect data on intervention uptake, fidelity of delivery in terms of content and quality of delivery of the intervention, as well as school and child engagement with the programme. Data were collected using registers of attendance, observations and checklists, field notes, focus groups with children and semi-structured interviews with teachers. Qualitative data were analysed thematically and quantitative data were summarized using descriptive statistics. Results: All 16 intervention schools received a complete or near complete programme (94-100%), which was delivered in the spirit in which it had been designed. Of the 676 children in the intervention schools, over 90% of children participated in each phase of HeLP; 92% of children across the socio-economic spectrum were deemed to be engaged with HeLP and qualitative data revealed a high level of enjoyment by all children, particularly to the interactive drama workshops. Further evidence of child engagment with the programme was demonstrated by children's clear understanding of programme messages around marketing, moderation and food labelling. Thirteen of the intervention schools were deemed to be fully engaged with HeLP and qualitative data revealed a high level of teacher 'buy in', due to the programme's compatability with the National Curriculum, level of teacher support and use of innovative and creative delivery methods by external drama practitioners. Conclusion: Our trial shows that it is possible to successfully scale up complex school-based interventions, engage schools and children across the socio-economic spectrum and deliver an intervention as designed. As programme integrity was maintained throughout the HeLP trial, across all intervention schools, we can be confident that the trial findings are a true reflection of the effectiveness of the intervention, enabling policy recommendations to be made. Trial registration: ISRCTN15811706. [ABSTRACT FROM AUTHOR]

Background: Many patients undergoing anaesthesia and surgery experience postoperative complications. Our aim was to investigate whether a systematic follow-up smartphone-based assessment, using recovery assessment by phone points (RAPP) compared with standard care, had a positive effect on day surgery patients' postoperative recovery. We also investigated whether there were differences in women and men's recovery and recovery scores.Methods: The study was a single-blind, multicentre randomized controlled trial. A total of 997 patients were randomly allocated to either RAPP or standard care. The Swedish web version of a quality of recovery (SwQoR) questionnaire was used to evaluate the patients' postoperative recovery, either on paper or using an application (RAPP) on postoperative days seven and 14.Results: On postoperative day seven the RAPP group reported significantly better values in seven out of 24 items of the SwQoR: sleeping difficulties; not having a general feeling of wellbeing; having difficulty feeling relaxed/comfortable; and dizziness; headache; pain in the surgical wound; and a swollen surgical wound compared with the control group, implying a good postoperative recovery. Both men and women in the RAPP group reported significantly better values (and, hence good postoperative recovery) compared with the control group in the items sleeping difficulties; not having a general feeling of wellbeing and pain in the surgical wound.Conclusions: Measurement of patient-reported outcomes using a smartphone-based application was associated with decreased discomfort from several postoperative symptoms. Systematic e-assessment can thereby increase patients' quality of recovery and identify key areas for improvement in perioperative care.Clinical Trial Registration: NCT02492191. [ABSTRACT FROM AUTHOR]

Background: Communities of practice are based on the idea that learning involves a group of people exchanging experiences and knowledge. The e-MPODERA project aims to assess the effectiveness of a virtual community of practice aimed at improving primary healthcare professional attitudes to the empowerment of patients with chronic diseases.Methods: This paper describes the protocol for a cluster randomized controlled trial. We will randomly assign 18 primary-care practices per participating region of Spain (Catalonia, Madrid and Canary Islands) to a virtual community of practice or to usual training. The primary-care practice will be the randomization unit and the primary healthcare professional will be the unit of analysis. We will need a sample of 270 primary healthcare professionals (general practitioners and nurses) and 1382 patients. We will perform randomization after professionals and patients are selected. We will ask the intervention group to participate for 12 months in a virtual community of practice based on a web 2.0 platform. We will measure the primary outcome using the Patient-Provider Orientation Scale questionnaire administered at baseline and after 12 months. Secondary outcomes will be the sociodemographic characteristics of health professionals, sociodemographic and clinical characteristics of patients, the Patient Activation Measure questionnaire for patient activation and outcomes regarding use of the virtual community of practice. We will calculate a linear mixed-effects regression to estimate the effect of participating in the virtual community of practice.Discussion: This cluster randomized controlled trial will show whether a virtual intervention for primary healthcare professionals improves attitudes to the empowerment of patients with chronic diseases.Trial Registration: ClicalTrials.gov, NCT02757781 . Registered on 25 April 2016. Protocol Version. PI15.01 22 January 2016. [ABSTRACT FROM AUTHOR]

Introduction: Little is known on how to communicate messages on tobacco constituents to tobacco users. This study manipulated three elements of a message in the context of a theory-based communication campaign about tobacco constituents: (1) latency of response efficacy (how soon expected health benefits would accrue), (2) self-efficacy (confidence about quitting), and (3) interrogative cue ("Ready to be tobacco-free?").Methods: Smokers (N = 1669, 55.4% women) were recruited via an online platform, and were randomized to a 3 (Latency of response efficacy) × 2 (Self-efficacy) × 2 (Interrogative cue) factorial design. The dependent variables were believability, credibility, perceived effectiveness of the communication message, and action expectancies (likelihood of seeking additional information and help with quitting).Results: Latency of response efficacy influenced believability, perceived effectiveness, credibility, and action expectancies. In each case, scores were higher when specific health benefits were said to accrue within 1 month, as compared to general health benefits occurring in a few hours. The interrogative cue had a marginal positive effect on perceived effectiveness. The self-efficacy manipulation had no reliable effects, and there were no significant interactions among conditions.Conclusions: Smokers appear less persuaded by a communication message on constituents where general health benefits accrue immediately (within a few hours) than specific benefits over a longer timeframe (1 month). Additionally, smokers appeared to be more persuaded by messages with an interrogative cue. Such findings may help design more effective communication campaigns on tobacco constituents to smokers.Implications: This paper describes, for the first time, how components of tobacco constituent messages are perceived. We now know that smokers appear to be less persuaded by communication messages where general health benefits accrue immediately (within a few hours) than specific benefits over a longer timeframe (1 month). Additionally, including an interrogative cue ("Ready to be tobacco free?") may make messages more effective, whereas the self-efficacy manipulation designed to increase confidence about quitting had no effect. While messages were universally impactful across smoker subpopulations, everyday smokers and smokers with less trust in the government may be less receptive to communication campaigns. [ABSTRACT FROM AUTHOR]

Background: The PARAMEDIC cluster randomised trial evaluated the LUCAS mechanical chest compression device, and did not find evidence that use of mechanical chest compression led to an improvement in survival at 30 days. This paper reports patient outcomes from admission to hospital to 12 months after randomisation.Methods: Information about hospital length of stay and intensive care management was obtained through linkage with Hospital Episode Statistics and the Intensive Care National Audit and Research Centre. Patients surviving to hospital discharge were approached to complete questionnaires (SF-12v2, EQ-5D, MMSE, HADS and PTSD-CL) at 90days and 12 months. The study is registered with Current Controlled Trials, number ISRCTN08233942.Results: 377 patients in the LUCAS arm and 658 patients in the manual chest compression were admitted to hospital. Hospital and intensive care length of stay were similar. Long term follow-up assessments were limited by poor response rates (53.7% at 3 months and 55.6% at 12 months). Follow-up rates were lower in those with worse neurological function. Among respondents, long term health related quality of life outcomes and emotional well-being was similar between groups. Cognitive function, measured by MMSE, was marginally lower in the LUCAS arm mean 26.9 (SD 3.7) compared to control mean 28.0 (SD 2.3), adjusted mean difference -1.5 (95% CI -2.6 to -0.4).Conclusion: There were no clinically important differences identified in outcomes at long term follow-up between those allocated to the mechanical chest compression compared to those receiving manual chest compression. [ABSTRACT FROM AUTHOR]

For decades various pressure ulcer risk assessment scales (PURAS) have been developed and implemented into nursing practice despite uncertainty whether use of these tools helps to prevent pressure ulcers. According to current methodological standards, randomised controlled trials (RCTs) are required to conclusively determine the clinical efficacy and safety of this risk assessment strategy. In these trials, PURAS-aided risk assessment has to be compared to nurses' clinical judgment alone in terms of its impact on pressure ulcer incidence and adverse outcomes. However, RCTs evaluating diagnostic procedures are prone to specific risks of bias and threats to the statistical power which may challenge their validity and feasibility. This discussion paper critically reflects on the rigour and feasibility of experimental research needed to substantiate the clinical efficacy of PURAS-aided risk assessment. Based on reflections of the methodological literature, a critical appraisal of available trials on this subject and an analysis of a protocol developed for a methodologically robust cluster-RCT, this paper arrives at the following conclusions: First, available trials do not provide reliable estimates of the impact of PURAS-aided risk assessment on pressure ulcer incidence compared to nurses' clinical judgement alone due to serious risks of bias and insufficient sample size. Second, it seems infeasible to assess this impact by means of rigorous experimental studies since sample size would become extremely high if likely threats to validity and power are properly taken into account. Third, means of evidence linkages seem to currently be the most promising approaches for evaluating the clinical efficacy and safety of PURAS-aided risk assessment. With this kind of secondary research, the downstream effect of use of PURAS on pressure ulcer incidence could be modelled by combining best available evidence for single parts of this pathway. However, to yield reliable modelling results, more robust experimental research evaluating specific parts of the pressure ulcer risk assessment-prevention pathway is needed. [ABSTRACT FROM AUTHOR]

This paper reports on the feasibility and preliminary effects of a decision aid (DA) about female fertility preservation (FP). We conducted a pilot multicentre randomized controlled trial of women with breast cancer aged 18–40 who were randomized to brochures or the DA. Over 18 months, 62 women were eligible, of which 42 were invited by their healthcare provider (74%) to participate in the study. A total of 36 women signed up for participation and 26 (72%) were randomized to brochures (n = 13) or the DA (n = 13). In both groups, many women (87%) read the brochures and eight women used all available brochures. In the intervention group, 7/13 women logged in to the DA. Women who received brochures had slightly less decisional conflict, whereas knowledge improved in both groups. Our results indicate that both brochures about FP and a detailed DA have beneficial effects with regard to knowledge, but the DA seemed to introduce slightly more decisional conflict (DC) than the brochures. Although we encountered challenges with recruitment, our design and measurements seem feasible and the effects of the information materials seem promising, hence justifying conducting a larger study. [ABSTRACT FROM PUBLISHER]

Background: Around a fifth of children starting school in England are now overweight/obese. There is a paucity of interventions with the aim of obesity prevention in preschool-age children in the UK. Previous research has demonstrated some positive results in changing specific health behaviours, however, positive trends in overall obesity rates are lacking. Preschool settings may provide valuable opportunities to access children and their families not only for promoting healthy lifestyles, but also to develop and evaluate behaviour-change interventions.Methods: This paper presents a cluster randomised feasibility study of a theory based behaviour-change preschool practitioner-led intervention tested in four preschool centres in the North East of England. The primary outcome measures were to test the acceptability and feasibility of the data collection measures and intervention. Secondary measures were collected and reported for extra information. At baseline and post intervention, children's anthropometric, dietary and physical activity measures as well as family 'active' time data were collected. The preschool practitioner-led intervention included family intervention tasks such as 'family goal-setting activities' and 'cooking challenges'. Preschool activities included increasing physical activity and providing activities with the potential to change behaviour with increased knowledge of and acceptance of healthy eating. The process evaluation was an on-going monthly process and was collected in multiple forms such as questionnaires, photographs and verbal feedback.Results: 'Gatekeeper' permission and lower-hierarchal adherence were initially a problem for recruitment and methods acceptance. However, at intervention end the preschool teachers and parents stated they found most intervention methods and activities acceptable, and some positive changes in family health behaviours were reported. However, the preschool centres appeared to have difficulties with enforcing everyday school healthy eating policies.Conclusions: The findings from the current study may have implications for nursery practitioners, nursery settings, Local Educational Authorities and policy makers, and contributes to the body of literature. However, further work with preschool practitioners is required to determine how personal attitudes and school policy application can be supported to implement successfully such an intervention.Trial Registration: ISRCTN12345678 (16/02/17) retrospectively registered. [ABSTRACT FROM AUTHOR]

Background: Colorectal cancer survivors are not only at risk for recurrent disease but also at increased risk of comorbidities such as other cancers, cardiovascular disease, diabetes, hypertension and functional decline. In this trial, we aim at investigating whether a diet in accordance with the Norwegian food-based dietary guidelines and focusing at dampening inflammation and oxidative stress will improve long-term disease outcomes and survival in colorectal cancer patients.Methods/design: This paper presents the study protocol of the Norwegian Dietary Guidelines and Colorectal Cancer Survival study. Men and women aged 50-80 years diagnosed with primary invasive colorectal cancer (Stage I-III) are invited to this randomized controlled, parallel two-arm trial 2-9 months after curative surgery. The intervention group (n = 250) receives an intensive dietary intervention lasting for 12 months and a subsequent maintenance intervention for 14 years. The control group (n = 250) receives no dietary intervention other than standard clinical care. Both groups are offered equal general advice of physical activity. Patients are followed-up at 6 months and 1, 3, 5, 7, 10 and 15 years after baseline. The study center is located at the Department of Nutrition, University of Oslo, and patients are recruited from two hospitals within the South-Eastern Norway Regional Health Authority. Primary outcomes are disease-free survival and overall survival. Secondary outcomes are time to recurrence, cardiovascular disease-free survival, compliance to the dietary recommendations and the effects of the intervention on new comorbidities, intermediate biomarkers, nutrition status, physical activity, physical function and quality of life.Discussion: The current study is designed to gain a better understanding of the role of a healthy diet aimed at dampening inflammation and oxidative stress on long-term disease outcomes and survival in colorectal cancer patients. Since previous research on the role of diet for colorectal cancer survivors is limited, the study may be of great importance for this cancer population.Trial Registration: ClinicalTrials.gov Identifier: NCT01570010 . [ABSTRACT FROM AUTHOR]