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

Background: The internet can provide evidence-based patient education to overcome time constraints of busy ambulatory practices. Health informationprescriptions (HIPs) can be effectivelyintegrated into clinic workflow, but compliance to visit health information sites such as Medline Plus is limited.Objective: Compare the efficacy of paper (pHIP)and email (eHIP) links to deliver HIPs; evaluate patient satisfaction with the HIP process and MedlinePlus information; assess reasons for noncompliance to HIPs.Method: Of 948 patients approached at two internal medicine clinics affiliated with an academic medical centre, 592 gave informed consent after meeting the inclusion criteria. In this randomised controlled trial, subjects were randomised to receive pHIP or eHIP for accessing an intermediate website that provided up to five MedlinePlus links for physician-selected HIP conditions. Patients accessing the intermediate website were surveyed by email to assess satisfaction with the health information.Survey non-responders were contacted by telephone to determine the reasons for no response.Results: One hundred and eighty-one patients accessed the website, with significantly more 'filling' eHIP than pHIP (38% vs 23%; P < 0.001). Most(82%) survey respondents found the website information useful, with 77% favouring email for future HIPs delivery. Lack of time, forgot, lost instructions or changed mind were reasons given for not accessing the websites.Conclusions: Delivery of MedlinePlus-based HIPs in clinic is more effective using email prescriptions than paper. Satisfaction with the HIP information was high, but overall response was low and deserves further investigation to improve compliance and related outcomes. [ABSTRACT FROM AUTHOR]

Background Diaries are used in sexual behaviour research to reduce recall bias. Diary collection via mobile phone text messaging (SMS) has not been trialled previously in sexual behaviour research. This randomized controlled trial compared SMS, paper and online diaries on response rate, timeliness, completeness of data and acceptability. The correlation between behaviour reported in all three types of diaries and data collected in a retrospective questionnaire was also determined. Methods Participants were recruited by telephone and randomised into one of three groups. They completed weekly sexual behaviour diaries for 3 months by SMS, online or paper (by post). An online survey was conducted at the end of 3 months to compare retrospective reports to the diaries and assess opinions on the diary collection method. Results 72 participants were enrolled in the study, 24 in each group. Online diaries were more likely to be submitted late than SMS diaries (p<0.001). 3.9% of SMS diaries, 3.1% of paper diaries and 0.5% of online diaries were incomplete (p=0.001). Online data collection was the preferred mode for 51%. 65 participants completed the end point retrospective questionnaire. The correlation between the diary and questionnaire on sexual risk classification was substantial (κ=0.74) regardless of diary mode. Conclusions SMS is a convenient and timely method of collecting brief behavioural data, but online data collection was preferable to most participants and more likely to be complete. Data collected in retrospective sexual behaviour questionnaires were found to agree substantially with data collected through weekly self-reported diaries. [ABSTRACT FROM AUTHOR]

Background: Anxiety and depressive disorders typically emerge in adolescence and can be chronic and disabling if not identified and treated early. School-based universal mental health screening may identify young people in need of mental health support and facilitate access to treatment. However, few studies have assessed the potential harms of this approach. This paper examines some of the potential mental health-related harms associated with the universal screening of anxiety and depression administered in Australian secondary schools. Methods: A total of 1802 adolescent students from 22 secondary schools in New South Wales, Australia, were cluster randomised (at the school level) to receive either an intensive screening procedure (intervention) or a light touch screening procedure (control). Participants in the intensive screening condition received supervised self-report web-based screening questionnaires for anxiety, depression and suicidality with the follow-up care matched to their symptom severity. Participants in the light touch condition received unsupervised web-based screening for anxiety and depression only, followed by generalised advice on help-seeking. No other care was provided in this condition. Study outcomes included the increased risk of anxiety, depression, psychological distress, decreased risk of help-seeking, increased risk of mental health stigma, determined from measures assessed at baseline, 6 weeks post-baseline, and 12 weeks post-baseline. Differences between groups were analysed using mixed effect models. Results: Participants in the intensive screening group were not adversely affected when compared to the light touch screening condition across a range of potential harms. Rather, participants in the intensive screening group were found to have a decreased risk of inhibited help-seeking behaviour compared to the light touch screening condition. Conclusions: The intensive screening procedure did not appear to adversely impact adolescents' mental health relative to the light touch procedure. Future studies should examine other school-based approaches that may be more effective and efficient than universal screening for reducing mental health burden among students. Trial registration Australian and New Zealand Clinical Trials Registry (ACTRN12618001539224) https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=375821. [ABSTRACT FROM AUTHOR]

Background: Co-occurring physical and mental health conditions are common, but effective and sustainable interventions are needed for primary care settings. Purpose: Our paper analyzes the effectiveness of a Solution-Focused Brief Therapy (SFBT) intervention for treating depression and co-occurring health conditions in primary care. We hypothesized that individuals receiving the SFBT intervention would have statistically significant reductions in depressive and anxiety symptoms, systolic blood pressure (SBP), hemoglobin A1C (HbA1c), and body mass index (BMI) when compared to those in the control group. Additionally, we hypothesized that the SFBT group would have increased well-being scores compared to the control group. Methods: A randomized clinical trial was conducted at a rural federally qualified health center. Eligible participants scored ≥ 10 on the Patient Health Questionnaire (PHQ-9) and met criteria for co-occurring health conditions (hypertension, obesity, diabetes) evidenced by chart review. SFBT participants (n = 40) received three SFBT interventions over three weeks in addition to treatment as usual (TAU). The control group (n = 40) received TAU over three weeks. Measures included depression (PHQ-9) and anxiety (GAD-7), well-being (Human Flourishing Index), and SFBT scores, along with physical health outcomes (blood pressure, body mass index, and hemoglobin A1c). Results: Of 80 consented participants, 69 completed all measures and were included in the final analysis. 80% identified as female and the mean age was 38.1 years (SD = 14.5). Most participants were white (72%) followed by Hispanic (15%) and Black (13%). When compared to TAU, SFBT intervention participants had significantly greater reductions in depression (baseline: M = 18.17, SD = 3.97, outcome: M = 9.71, SD = 3.71) and anxiety (baseline: M = 14.69, SD = 4.9, outcome: M = 8.43, SD = 3.79). SFBT intervention participants also had significantly increased well-being scores (baseline: M = 58.37, SD = 16.36, outcome: M = 73.43, SD = 14.70) when compared to TAU. Changes in BMI and blood pressure were not statistically significant. Conclusion: The SFBT intervention demonstrated efficacy in reducing depressive and anxiety symptoms and increasing well-being but did not affect cardio-metabolic parameters over a short period of intervention. Trial Registration: The study was pre-registered at ClinicalTrials.gov Identifier: NCT05838222 on 4/20/2023. *M = Mean, SD = Standard deviation. [ABSTRACT FROM AUTHOR]

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

Children of parents with mental illness are at higher risk of developing cognitive, mental health or physical health difficulties. Previous studies have described several barriers for reaching parents with mental health problems (MHPs) and their utilization of psychosocial services. We conducted a cluster randomized controlled study in 24 pediatric and gynecologic practices to evaluate KID-PROTEKT, a psychosocial healthcare intervention that comprises a psychosocial assessment to identify families with psychosocial needs and refer them to support services. In this paper, we analyzed whether psychosocially distressed parents with additional MHPs (identified by the PHQ-9 and GAD-7) had higher support needs, could be referred to support and utilized it in comparison to parents with psychosocial burden only. In total, 178 pregnant women and mothers with psychosocial burden were included, of whom 55 had MHPs. Participants with MHPs were distressed in their relationships more often and medical staff rated their level of support needs higher compared to parents without MHPs. There were no significant differences between the groups regarding whether they were referred to support services or utilized the recommended services. All participants were most frequently referred to family or parent counseling/care or childcare assistance. The results indicate that despite existing barriers, parents with MHPs could be reached and identified by the KID-PROTEKT psychosocial assessment. A psychosocial intervention like KID-PROTEKT can help to provide support for mentally ill parents. [ABSTRACT FROM AUTHOR]

Background: A cluster randomised controlled trial demonstrated the effectiveness of the SMART Work & Life (SWAL) behaviour change intervention, with and without a height-adjustable desk, for reducing sitting time in desk-based workers. Staff within organisations volunteered to be trained to facilitate delivery of the SWAL intervention and act as workplace champions. This paper presents the experiences of these champions on the training and intervention delivery, and from participants on their intervention participation. Methods: Quantitative and qualitative feedback from workplace champions on their training session was collected. Participants provided quantitative feedback via questionnaires at 3 and 12 month follow-up on the intervention strategies (education, group catch ups, sitting less challenges, self-monitoring and prompts, and the height-adjustable desk [SWAL plus desk group only]). Interviews and focus groups were also conducted at 12 month follow-up with workplace champions and participants respectively to gather more detailed feedback. Transcripts were uploaded to NVivo and the constant comparative approach informed the analysis of the interviews and focus groups. Results: Workplace champions rated the training highly with mean scores ranging from 5.3/6 to 5.7/6 for the eight parts. Most participants felt the education increased their awareness of the health consequences of high levels of sitting (SWAL: 90.7%; SWAL plus desk: 88.2%) and motivated them to change their sitting time (SWAL: 77.5%; SWAL plus desk: 85.77%). A high percentage of participants (70%) reported finding the group catch up session helpful and worthwhile. However, focus groups highlighted mixed responses to the group catch-up sessions, sitting less challenges and self-monitoring intervention components. Participants in the SWAL plus desk group felt that having a height-adjustable desk was key in changing their behaviour, with intrinsic as well as time based factors reported as key influences on the height-adjustable desk usage. In both intervention groups, participants reported a range of benefits from the intervention including more energy, less fatigue, an increase in focus, alertness, productivity and concentration as well as less musculoskeletal problems (SWAL plus desk group only). Work-related, interpersonal, personal attributes, physical office environment and physical barriers were identified as barriers when trying to sit less and move more. Conclusions: Workplace champion and participant feedback on the intervention was largely positive but it is clear that different behaviour change strategies worked for different people indicating that a 'one size fits all' approach may not be appropriate for this type of intervention. The SWAL intervention could be tested in a broader range of organisations following a few minor adaptations based on the champion and participant feedback. Trial registration: ISCRCTN registry (ISRCTN11618007). [ABSTRACT FROM AUTHOR]

Background: The transition from hospital to community settings for most mental health service users is often hindered by challenges that affect community adjustment and continuity of care. The first few weeks and days after discharge from mental health inpatient units represent a critical phase for many service users. This paper aims to evaluate the changes in the resilience, personal recovery, and quality of life status of individuals with mental health challenges recently discharged from acute mental health care into the community. Methods: Data for this study were collected as part of a pragmatic stepped-wedge cluster-randomized, longitudinal approach in Alberta. A paired sample t-test and Chi-squared/Fisher test were deployed to assess changes from baseline to six weeks in the recovery assessment scale (RAS), brief resilience scale (BRS), and EuroQol-5d (EQ-5D), using an online questionnaire. Results: A total of 306 service users were recruited and 88 completed both baseline and six weeks, giving a response rate of 28.8%. There was no statistically significant change in the level of resilience, recovery and quality of life as measured with the brief resilience scale, recovery assessment scale and EQ-5D from baseline to six weeks (p > 0.05). Conclusions: The study showed that there was neither an improvement nor deterioration in resilience, recovery, or quality of life status of service users six weeks post-discharge from inpatient mental health care. The lack of further progress calls into question whether the support available in the community when patient's leave inpatient care is adequate to promote full recovery. The results justify investigations into the effectiveness of innovative and cost-effective programs such as peer and text-based supportive interventions for service users discharged from inpatient psychiatric care. [ABSTRACT FROM AUTHOR]

The purpose of this paper is to provide a group music therapy intervention for elementary and middle school students with mood disorders through music therapy. To explore the improvement of group music therapy on the dysphoria and state of adolescent patients with mood disorders and to explore the relationship with self-identity. A music activity-based mental health education curriculum was designed based on the results of the current survey, while two homogenous classes were selected as the experimental and control classes; subsequently, the experimental teaching of the music activity-based mental health education curriculum was conducted in the experimental class, and the regular school mental health education curriculum was conducted in the control class, and the pre- and postexperimental scale tests were used to analyze that the curriculum of this study had a positive effect of this study's curriculum on elementary school students' positive emotions analyzed through pre- and postexperimental scale tests. The music activity-based mental health education program had a significant positive effect on the overall level of positive emotions of elementary school students, especially in the positive emotion index, happiness index, mental toughness, goal focus, and interpersonal assistance factor. The positive psychology-oriented music activity-based mental health education curriculum is well suited for elementary and middle school students, especially for upper elementary and middle school students. The music activity-based mental health education curriculum realizes the value of applying positive psychology to mental health education efforts at the elementary school level and flexibly uses a variety of related theories to promote positive emotional experiences for elementary and middle school students. [ABSTRACT FROM AUTHOR]

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

Introduction: The creation of digestive stomata is associated with a change in people's lives. Causing a strong impact that influences all dimensions of life. This paper reports on the effects of socio-educational interventions on the quality of life (QOL) of people with a digestive ostomy. Objective: To describe the effect of a nursing intervention on the QOL of people with a digestive ostomy. Methods: A quasiexperimental study was conducted whose sample consisted of 12 people who were ostomized in a public hospital in Colombia. Participants were selected through convenience sampling and randomly assigned to the intervention group and the control group. For the control group, an educational process was carried out through a theoretical session with virtual mediation (educational video). The QOL was evaluated before and after the interventions through the Montreux questionnaire. Results: The average age was 57(+7) years. No statistical differences were found between the groups in the QOL index or for any of the dimensions that make up QOL. Pretest and post-test analysis for each intervention separately showed improvement in two dimensions of QOL for each group; in the intervention group body image dimension (p =.017) and the positive coping dimension (p =.027). In the control group, the physical well-being dimension (p =.037) and social concerns dimension (p =.034). Conclusions: The personalized educational intervention or carried out through virtual pedagogical mediation, generated a clinically significant increase in the dimensions of QOL, without statistical differences. The study adds knowledge about the impact that digestive stomata have on the QOL, which is why it is necessary to establish specialized interdisciplinary teams to care for the person's new condition at home during the following months. [ABSTRACT FROM AUTHOR]

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

The hospitalization and the unfamiliar experiences of patients in interventional radiology procedures cause a moderate to high levels of anxiety. This study was aimed to evaluate the anxiolytic effect of Cananga odorata essential oil (COE) aromatherapy in unexperienced patients hospitalized for interventional neuroradiology (INR) procedures. Forty-four patients admitted for their first INR procedure were randomly divided into COE and placebo control groups. COE or distilled water was dropped onto 2 pieces of mulberry paper and attached to the participant's gown at the shoulder level overnight. The main outcomes were observed from the morning salivary cortisol levels and salivary alpha-amylase activity after intervention. The Thai version of Spielberger State-Trait Anxiety Inventory (STAI) and the vital signs (blood pressure and heart rate) were also assessed before and after COE intervention as the secondary outcome. The demographic and baseline data of both groups did not show any significant difference. After intervention, COE group had a significantly lower salivary alpha-amylase activity than placebo control group. The post-intervention scores of Trait (STAI-T) and State (STAI-S) anxiety were significantly less than those of baseline in both groups. Interestingly, the COE group had a greater percentage reduction on STAI-T after intervention than placebo control group. No significant difference was observed in other outcomes. In addition, the salivary alpha-amylase activity was weak but showed significant correlation with STAI anxiety scores. This study indicates that COE aromatherapy reduces the saliva alpha amylase activity and STAI-T anxiety in unexperienced patients hospitalized for INR procedures. [ABSTRACT FROM AUTHOR]

The hospitalization and the unfamiliar experiences of patients in interventional radiology procedures cause a moderate to high levels of anxiety. This study was aimed to evaluate the anxiolytic effect of Cananga odorata essential oil (COE) aromatherapy in unexperienced patients hospitalized for interventional neuroradiology (INR) procedures. Forty-four patients admitted for their first INR procedure were randomly divided into COE and placebo control groups. COE or distilled water was dropped onto 2 pieces of mulberry paper and attached to the participant's gown at the shoulder level overnight. The main outcomes were observed from the morning salivary cortisol levels and salivary alpha-amylase activity after intervention. The Thai version of Spielberger State-Trait Anxiety Inventory (STAI) and the vital signs (blood pressure and heart rate) were also assessed before and after COE intervention as the secondary outcome. The demographic and baseline data of both groups did not show any significant difference. After intervention, COE group had a significantly lower salivary alpha-amylase activity than placebo control group. The post-intervention scores of Trait (STAI-T) and State (STAI-S) anxiety were significantly less than those of baseline in both groups. Interestingly, the COE group had a greater percentage reduction on STAI-T after intervention than placebo control group. No significant difference was observed in other outcomes. In addition, the salivary alpha-amylase activity was weak but showed significant correlation with STAI anxiety scores. This study indicates that COE aromatherapy reduces the saliva alpha amylase activity and STAI-T anxiety in unexperienced patients hospitalized for INR procedures. [ABSTRACT FROM AUTHOR]

Background: Patient-reported outcomes (PROs) refer to any report of the status of a patient's health condition, health behavior, or experience with healthcare directly from the patient, without interpretation of the patient's response by a clinician or any other external party. While many PROs, such as the Pediatric Quality of Life Inventory (PedsQL), were originally administered in paper-and-pencil format, these are now available as electronic versions (ePROs). Although ePROs might well have used the same structure as their paper versions, we developed an alternate ePedsQL incorporating three software functions: 1) a non-forcing non-response alert, 2) a conditional question branch of the School Functioning Scale that only displays for (pre) school children, and 3) a vertical item-by-item display for small-screen devices. This report evaluated the effect of these functions on item non-response rate, survey completion time, and user experience. Methods: All surveys were conducted via the online/computer mode. We compared the dynamic format containing the three functions with the basic format in a randomized comparative study in 2803 children and 6289 caregivers in Japan. Results: We found that the non-response alert lowered the item non-response rate (0.338% to 0.046%, t = − 4.411, p < 0.001 by generalized linear mixed model analysis). The conditional question branch had mixed effects on survey completion time depending on the respondents' age. Surprisingly, respondents rated the vertical question display for handheld devices less legible than the matrix format. Further, multigroup structural equation modelling revealed that the same configuration for both formats showed an acceptable fit (CFI 0.933, RMSEA 0.060, SRMR 0.038) but the errors of observed variables were larger for the dynamic format than the basic format. Conclusions: We confirmed the robustness of the ePedsQL in different formats. The non-response rate of ePedsQL was very low even in the absence of an alert. The branch and item-by-item display were effective but unnecessary for all populations. Our findings further understanding of how humans respond to special software functions and different digital survey formats and provide new insight on how the three tested functions might be most successfully implemented. [ABSTRACT FROM AUTHOR]

Background: The ICECAP measures potentially offer a broader assessment of quality of life and well-being, in comparison to measures routinely used in economic evaluation, such as the EQ-5D-3 L. This broader assessment may allow measurement of the full effects of an intervention or treatment. Previous research has indicated that the ICECAP-O (for older people) and EQ-5D-3 L measure provide complementary information. This paper aims to determine similar information for the ICECAP-A (for the entire adult population) in terms of whether the measure is a substitute or complement to the EQ-5D-3 L.Methods: Data from the BEEP trial - a multi-centre, pragmatic, randomised controlled trial - were used. Spearman rank correlations and exploratory factor analytic methods were used to assess whether ICECAP-A and EQ-5D-3 L are measuring the same, or different, constructs.Results: A correlation of 0.49 (p < 0.01) was found between the ICECAP-A tariff score and the EQ-5D-3 L index. Using the pooled items of the EQ-5D-3 L and the ICECAP-A a two factor solution was optimal, with the majority of EQ-5D-3 L items loading onto one factor and the majority of ICECAP-A items onto another.Conclusion: The results presented in this paper indicate that ICECAP-A and EQ-5D-3 L are measuring two different constructs and provide largely different, complementary information. Results showed a similarity to results presented by Davis et al. using the ICECAP-O.Trial Registration: ISRCTN 93634563. [ABSTRACT FROM AUTHOR]

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Good nutrition in the early years of life is vitally important for a child's development, growth and health. Children's diets in the United Kingdom are known to be poor, particularly among socially disadvantaged groups, and there is a need for timely and appropriate interventions that support parents to improve the diets of young children. The Medical Research Council has highlighted the importance of conducting developmental and exploratory research prior to undertaking full-scale trials to evaluate complex interventions, but have provided very limited detailed guidance on the conduct of these initial phases of research. This paper describes the initial developmental stage and the conduct of an exploratory randomised controlled trial undertaken to determine the feasibility and acceptability of a family-centred early years' nutrition intervention. Choosing Healthy Eating when Really Young ( CHERRY) is a programme for families with children aged 18 months to 5 years, delivered in children's centres in one urban ( Islington) and one rural ( Cornwall) location in the United Kingdom. In the development stage, a mixed-methods approach was used to investigate the nature of the problem and options for support. A detailed review of the evidence informed the theoretical basis of the study and the creation of a logic model. In the feasibility and pilot testing stage of the exploratory trial, 16 children's centres, with a sample of 394 families were recruited onto the study. We hope that the methodology, which we present in this paper, will inform and assist other researchers in conducting community-based, exploratory nutrition research in early years settings. [ABSTRACT FROM AUTHOR]

Background: Interventions targeting community health workers (CHWs) aim to optimise the delivery of health services to underserved rural areas. Whilst interventions are evaluated against their objectives, there remains limited evidence on the economic costs of these interventions, and the practicality and value of scale up. The aim of this paper is to undertake a cost analysis on a CHW training and supervision intervention using exclusive breastfeeding rates amongst mothers as an outcome measure.Methods: This is a retrospective cost analysis, from an implementer's perspective, of a cluster randomised controlled trial investigating the effectiveness of a continuous quality improvement (CQI) intervention aimed at CHWs providing care and support to pregnant women and women with babies aged < 1 year in South Africa.Results: One of the outcomes of the RCT revealed that the prevalence of exclusive breastfeeding (EBF) significantly improved, with the cost per mother EBF in the control and intervention arm calculated at US$760,13 and US$1705,28 respectively. The cost per additional mother practicing EBF was calculated to be US$7647, 88, with the supervision component of the intervention constituting 64% of the trial costs. In addition, women served by the intervention CHWs were more likely to have received a CHW visit and had significantly better knowledge of childcare practices.Conclusion: Whilst the cost of this intervention is high, adapted interventions could potentially offer an economical alternative for achieving selected maternal and child health (MCH) outcomes. The results of this study should inform future programmes aimed at providing adapted training and supervision to CHWs with the objective of improving community-level health outcomes. [ABSTRACT FROM AUTHOR]

Background: Poly-victimization (PV) not only threatens physical and mental health but also causes a range of social problems. Left-behind children in rural areas are more likely to experience PV problems. However, there have been fewer studies on PV among rural children, and even fewer intervention studies. Objective: The difference-in-differences method was employed to analyze the impact of intervention measures, based on the theory of planned behavior, on PV among left-behind children in rural areas. Methods: The study subjects were left-behind children from six middle schools in two cities in southern China, who completed the baseline survey from 2020 to 2021. They were divided into a control group and an intervention group, each consisting of 228 cases, based on their schools. Before and after the intervention, the Self-made victimization-related knowledge, attitude, and practice questionnaire, Poly-victimization scale, and Middle school students' coping style scale were used to evaluate the victimization-related KAP(knowledge, attitude, and practice), victimization occurrence, and coping styles of left-behind children, respectively. Stata 15.0 was used to establish a difference-in-differences regression model to analyze the impact of the intervention measures on poly-victimization and coping styles. Results: Mixed Anova revealed that after the intervention, the KAP scores of the intervention group were significantly higher than those of the control group (p < 0.05). After the intervention, the incidence of child victimization in the intervention group dropped to 9.60% (n = 22), lower than in the baseline survey, with a statistically significant difference (p < 0.01). The incidence of PV among children in the intervention group was lower than that in the control group, with the difference being statistically significant (p < 0.01). The net reduction in the incidence of PV among children was 21.20%. After the intervention, the protection rate for preventing PV among children was 73.33%, and the effect index was 3.75. The intervention improved children's coping styles, problem-solving, and help-seeking, while reducing negative coping styles such as avoidance and venting, with the differences being statistically significant (p < 0.05). Conclusion: Intervention measures based on the theory of planned behavior reduce the occurrence of PV among left-behind children, and the intervention effects on different types of victimization are also different. [ABSTRACT FROM AUTHOR]

Background: For patients with sepsis receiving non-invasive ventilation (NIV), early rehabilitation is crucial. The Sitting Baduanjin (SBE) is an efficient early rehabilitation exercise suitable for bed patients. There is no consensus about the effect of SBE on the early rehabilitation of septic patients with NIV. This study focused on how the SBE affected the early rehabilitation of sepsis patients with NIV. Methods: 96 sepsis patients with NIV were randomly assigned to either an Baduanjin group that received the SBE based on the routine rehabilitation exercise (n = 48) or a control group (n = 48) that received routine rehabilitation exercise. The primary outcome was the Medical Research Council(MRC)score, and the Barthel Index score, the duration of NIV, length of ICU stay, length of total stay, hospitalization expense as secondary outcomes. Results: A total of 245 sepsis patients were screened, with 96 randomly assigned. The study was completed by 90 patients out of the 96 participants.Results revealed that the MRC score increased in both groups, but the improvement of muscle strength in Baduanjin group was more obvious, with statistical significance (p < 0.001).There was statistically significantly difference between the two groups in Barthel Index at the day of transfer out of ICU(P = 0.028).The patients in the Baduanjin group had an average reduction of 24.09 h in the duration of NIV and 3.35 days in total length of hospital stay compared with the control group (p < 0.05).Of note, the Baduanjin group had significantly reduction the total hospitalization expense. No serious adverse events occurred during the intervention period. Conclusions: In patients with sepsis, the SBE appears to improve muscle strength and activities of daily living (ADL), and lowed the duration of NIV, the length of the total stay, and the hospitalization expense. Trial registration: The study registered on the Chinese Clinical Trial Registry (www.chictr.org.cn), Clinical Trials identifier ChiCTR1800015011 (28/02/2018). [ABSTRACT FROM AUTHOR]

Frailty is a common condition in older adults that negatively impacts health and quality of life. This study evaluated a comprehensive, personalised, and coordinated intervention under the value-based care approach to address frailty's multidimensional nature in older people in the primary care setting. It employed a pre–post randomised controlled design involving 242 frail individuals aged over 65 years living in the community in Valencia (Spain) between 2021 and 2023. Assessments were conducted at baseline, 12 months (immediately post-intervention), and 18 months. The intervention included a personalised care plan supported by technology, with monthly motivational follow-ups and plan updates by health professionals and participants. Outcomes were measured using an assessment questionnaire that included the International Consortium for Health Outcomes Measurement dataset for the older population: physical health, physical functioning, general mental health, satisfaction with social activities and relationships, ability to carry out usual social roles and activities, pain, general quality of life, loneliness, physical frailty, psychological frailty, and social frailty. The study found significant improvements in physical frailty, quality of life, reduced health resource use and hospitalisations and lower levels of pain and depression/anxiety compared to baseline. The findings suggest further research into value-based care approaches, emphasizing the development and activation of personalised, comprehensive programs for older individuals with frailty. [ABSTRACT FROM AUTHOR]

This study aimed to identify differences among body mass index (BMI) categories of older family caregivers (=60 years) and their care recipients (=65 years). Secondly, this study aimed to examine group differences and factors associated with weight change during a nutrition and oral health intervention. This secondary analysis of a randomized controlled trial (ClinicalTrial.gov (NCT04003493)) involved individually tailored nutritional guidance from a clinical nutritionist and oral health guidance from a dental hygienist. Baseline BMI differences were analyzed, followed by further analyses of group differences and associated factors of weight change over a 6-month period using generalized estimating equations. Among the participants (113 family caregivers and 107 care recipients), 36.3% and 35.1% were overweight (BMI >29 kg/m²), while 18.6% and 21.6% were underweight (BMI <24 kg/m²) at baseline, respectively. For family caregivers differences in BMI categories included age, mid-arm and calf circumferences, and plasma prealbumin concentration. For care recipients differences were observed in medication use, mid-arm and calf circumferences, Mini Nutritional Assessment scores, physical function, and number of teeth. During the 6-month intervention, there were no differences in weight change between intervention and control groups for both caregivers and care recipients. Factors significantly associated (p < 0.05) with weight loss included female sex for both caregivers and care recipients, and frailty for caregivers. Family caregivers' characteristics were not significantly associated with weight change in their care recipients. In conclusion, being overweight is a prevalent among older family caregivers and care recipients. Factors such as age, medication use, physical function, number of teeth, and Mini Nutritional Assessment scores varied across BMI categories. Female sex was associated with weight loss in both older family caregivers and care recipients, and frailty was associated with weight loss in caregivers. However, the characteristics of family caregivers did not explain the weight loss of their care recipients. [ABSTRACT FROM AUTHOR]

Background: It is common to see patients who need orthodontic treatment but with insufficient alveolar bone volume. However, safe and effective tooth movement requires sufficient alveolar bone width and height. The aim of this study is to compare the bone augmentation efficacy of Autologous Partially Demineralized Dentin Matrix (APDDM) and Deproteinized Bovine Bone Mineral (DBBM) in orthodontic patients with insufficient bone by using a randomized controlled clinical trial approach. Materials and methods: Twenty-seven orthodontic patients involving 40 posterior teeth alveolar sites (n = 40) with insufficient alveolar bone volume were randomly divided into a control group (n = 20) and an experimental group (n = 20). The patients in the experimental group were treated with APDDM, and those in the control group were treated with DBBM. After surgery, the adjacent teeth are moved toward the bone grafting sites according to the orthodontic treatment plan. Patients completed a postoperative response questionnaire by the Visual Analogue Scale (VAS) score to indicate pain and swelling in the bone grafted area at the time of suture removal; and CBCT scans were conducted before surgery, 6 months and 2 years after surgery to assess changes in buccal and central alveolar heights, as well as widths at the alveolar ridge apex and 3 mm, 5 mm below the apex, respectively. The CBCT image sequences were imported into Mimics 21.0 software in DICOM format. The data of the patients in both groups were collected and analyzed by SPSS 25.0. Results: The VAS scores were significantly lower in the APDDM group than in the DBBM group (p < 0.05). Significant increases were observed in alveolar bone height and width at 6 months and 2 years postoperative (p < 0.05); At 2 years, the APDDM group exhibited a reduction in buccal crest height and in 3 mm, 5 mm width below alveolar ridge apex, relative to 6 months (p < 0.05), while the DBBM group showed a decrease only in the central height of the alveolar bone (p < 0.05). There was a significant bone augmentation increase found only 3 mm below the alveolar ridge apex in the APDDM group compared with the DBBM group among all 6 months group comparison (p < 0.05). At 2 years, the augmentation effects were similar across both groups (p > 0.05). Conclusion: Radiomics analysis indicates that APDDM serves as a viable bone augmentation material for orthodontic patients with insufficient alveolar bone volume, achieving comparable clinical efficacy to DBBM. Additionally, APDDM is associated with a milder postoperative response than DBBM. The registration number (TRN): ChiCTR2400084607. [ABSTRACT FROM AUTHOR]

Building on the premises of Positive Psychology, this undertaking conducted a pilot study of the designed 14-session Positive Psychology Intervention (PPI) program established based on the character strengths and virtues (CSV) of persons who use drugs (PWUDs) to assess its usefulness, delivery details, and impacts. Conducted in one of the biggest Drug Abuse Treatment and Rehabilitation Center in the Philippines, 24 PWUDs were randomly selected by the program staff to participate in its pilot run while securing all necessary ethical guidelines and requirements. Via within-subjects pretest-posttest experimental design, the especially adapted and developed tools were used to assess the PWUDs' progress as they were facilitated by the said program. Results yielded significant improvements in the PWUDs' mental wellbeing (M = 1.29, SD = 0.35; t (21) = 9.30, P <.00001), life satisfaction (M = 1.82, SD = 0.24; t (21) = 9.89, P <.00001), and psychological functioning (M = 1.65, SD = 0.19; t (21) = 8.58, P <.00001). Moreover, the PWUDs regarded the designed PPI program very highly and experienced it with positive outcomes, especially for their CSVs. Further improvement of the said program centers around proper time allotment, number of participants in the program sessions, appropriate activities per session, including specific ice breaker games, activity materials needed, and the proper sequencing of each session. These data are used to improve the PPI program structures and components. Pertinent conclusions about the gathered data were drawn, and relevant recommendations were also thereby provided. [ABSTRACT FROM AUTHOR]

Depression is one of the most prevalent mental disorders worldwide. This study examined the effect of a spiritual connectivity intervention on individuals with depression in a randomized waitlist-controlled trial. Fifty-seven participants with mild or moderate depressive symptoms were randomly assigned to either the intervention group (n = 28) or the waitlist control group (n = 29). The intervention comprised eight weekly sessions focusing on divine connection, forgiveness and freedom, suffering and transcendence, hope, gratitude, and relapse prevention. The outcome measures included depressive symptoms, anxiety, hope, meaning in life, self-esteem, and social support. Participants completed self-administered questionnaires at baseline (week 0), post-intervention (week 8), and 3-month follow-up (week 20). Repeated-measures ANOVA and one-way ANCOVA were used to compare the within-group and between-group differences in the changes in outcome variables. Participants in the intervention group showed significant improvements in depression, anxiety, spiritual experience, hope, self-esteem, and perceived social support after the intervention. Effect size statistics showed small to large differences (Cohen's d, 0.308 to −1.452). Moreover, 85.71% of participants in the intervention group also experienced clinically significant reductions in PHQ-9 scores from baseline to immediate post-intervention. This study highlights the effectiveness of a low-cost, accessible intervention suitable for community implementation by clergy and faith-based organizations. [ABSTRACT FROM AUTHOR]

This study aimed to determine the effects of virtual reality (VR)-based meditation on the sleep quality, stress, and autonomic nervous system balance of nursing students. Nursing students were categorized into experimental groups I (VR-based meditation) and II (concentration meditation) and a control group. Before the study's initiation, we measured the participants' general characteristics, and a sleep measurement device was used to measure sleep quality. Stress levels and heart rate variability were measured before and after study completion. On the first day, all three groups slept without any intervention. On days 2–6, only experimental groups I and II implemented the intervention before sleeping. We found that the subjective sleep quality, wakefulness after sleep onset, sleep efficiency, deep sleep quality, subjective stress, objective stress, and autonomic nervous system balance of the VR meditation group were significantly better than those of the other groups. Our results reveal that the participants who underwent VR-based meditation experienced better sleep quality, lower stress levels, and improved autonomic nervous system balance compared with those in the concentration meditation and control groups. Thus, VR-based meditation effectively enhances sleep quality, lowers stress levels, and improves autonomic nervous system balance in nursing students. [ABSTRACT FROM AUTHOR]

Background: Non-invasive neuroregulation techniques have been demonstrated to improve certain motor symptoms in Parkinson's disease (PD). However, the currently employed regulatory techniques primarily concentrate on stimulating single target points, neglecting the functional regulation of networks and circuits. The supplementary motor area (SMA) has a significant value in motor control, and its functionality is often impaired in patients with PD. The matching SMA-primary motor cortex (M1) paired transcranial magnetic stimulation (TMS) treatment protocol, which benefits patients by modulating the sequential and functional connections between the SMA and M1, was elucidated in this study. Methods: This was a single-center, double-blind, randomized controlled clinical trial. We recruited 78 subjects and allocated them in a 1:1 ratio by stratified randomization into the paired stimulation (n = 39) and conventional stimulation groups (n = 39). Each patient underwent 3 weeks of matching SMA-M1 paired TMS or sham-paired stimulation. The subjects were evaluated before treatment initiation, 3 weeks into the intervention, and 3 months after the cessation of therapy. The primary outcome measure in this study was the Unified Parkinson's Disease Rating Scale III, and the secondary outcome measures included non-motor functional assessment, quality of life (Parkinson's Disease Questionnaire-39), and objective assessments (electromyography and functional near-infrared spectroscopy). Discussion: Clinical protocols aimed at single targets using non-invasive neuroregulation techniques often improve only one function. Emphasizing the circuit and network regulation in PD is important for enhancing the effectiveness of TMS rehabilitation. Pairing the regulation of cortical circuits may be a potential treatment method for PD. As a crucial node in motor control, the SMA has direct fiber connections with basal ganglia circuits and complex fiber connections with M1, which are responsible for motor execution. SMA regulation may indirectly regulate the function of basal ganglia circuits. Therefore, the developed cortical pairing stimulation pattern can reshape the control of information flow from the SMA to M1. The novel neuroregulation model designed for this study is based on the circuit mechanisms of PD and previous research results, with a scientific foundation and the potential to be a means of neuroregulation for PD. [ABSTRACT FROM AUTHOR]

Background: This study demonstrates how formative process evaluation was used to assess implementation and improve dose and fidelity in the Together Everyone Achieves More Physical Activity (TEAM-PA) randomized controlled trial. TEAM-PA uses a randomized group cohort design to evaluate the efficacy of a group-based intervention for increasing physical activity among African American women. Methods: Intervention groups met for 10 weeks and were co-led by female African American facilitators, with intervention sessions consisting of group feedback, a health curriculum, group-based physical activity games, and group-based goal-setting. Drawing from a multi-theoretical framework, the intervention targeted social affiliation using collaborative and competitive group strategies, including essential elements focused on group-based behavioral skills, peer-to-peer positive communication, collectivism, optimal challenge, social facilitation, and peer to peer challenges. Formative process evaluation was used to monitor reach, dose, and fidelity, and implement feedback and solutions. Results: Across two cohorts, four groups (n = 54) were randomized to the TEAM-PA intervention. On average 84.8% of participants attended each week, which exceeded the a priori criteria. Results from the systematic observations indicated that on average 93% of the dose items were completed in each session and adequate levels of fidelity were achieved at both the facilitator and group-levels. Participants were compliant with wearing the FitBits (6.73 ± 0.42 days/week) and most participants successfully contributed to meeting the group-based goals. The use of open-ended items also revealed the need for additional modifications to the group-based PA games, including allowing for individuals to take breaks, incorporating a broader range of exercises, minimizing activities that required bending/reaching down without assistance, and providing facilitators with additional training for implementing the games. Initial evidence suggests that these changes were successful in increasing participants' comprehension of the games from Cohort 1 (M = 1.83, SD = 0.71) to Cohort 2 (M = 3.33, SD = 0.69). Conclusion: Findings from this study demonstrated high levels of reach, dose, and fidelity, while also highlighting strategies for implementing competitive group-based PA games that are accessible across physical fitness levels. Formative process evaluation, including open-ended items and collaborative brainstorming, holds tremendous potential for improving future interventions. Trial registration: This study was registered on Clinicaltrials.gov (# NCT05519696) on August 22, 2022 prior to the enrollment of the first participant on September 12, 2022 (https://clinicaltrials.gov/study/NCT05519696?term=NCT05519696&rank=1). [ABSTRACT FROM AUTHOR]

Background: Depression is viewed as a major and increasing public health issue, as it causes high distress in the people experiencing it and considerable financial costs to society. Efforts are being made to reduce this burden by preventing depression. A critical component of this strategy is the ability to assess the individual level and profile of risk for the development of major depression. This paper presents the cost-effectiveness of a personalized intervention based on the risk of developing depression carried out in primary care, compared with usual care.Methods: Cost-effectiveness analyses are nested within a multicentre, clustered, randomized controlled trial of a personalized intervention to prevent depression. The study was carried out in 70 primary care centres from seven cities in Spain. Two general practitioners (GPs) were randomly sampled from those prepared to participate in each centre (i.e. 140 GPs), and 3326 participants consented and were eligible to participate. The intervention included the GP communicating to the patient his/her individual risk for depression and personal risk factors and the construction by both GPs and patients of a psychosocial programme tailored to prevent depression. In addition, GPs carried out measures to activate and empower the patients, who also received a leaflet about preventing depression. GPs were trained in a 10- to 15-h workshop. Costs were measured from a societal and National Health care perspective. Qualityadjustedlife years were assessed using the EuroQOL five dimensions questionnaire. The time horizon was 18 months.Results: With a willingness-to-pay threshold of €10,000 (£8568) the probability of cost-effectiveness oscillated from 83% (societal perspective) to 89% (health perspective). If the threshold was increased to €30,000 (£25,704), the probability of being considered cost-effective was 94% (societal perspective) and 96%, respectively (health perspective). The sensitivity analysis confirmed these results.Conclusions: Compared with usual care, an intervention based on personal predictors of risk of depression implemented by GPs is a cost-effective strategy to prevent depression. This type of personalized intervention in primary care should be further developed and evaluated.Trial Registration: ClinicalTrials.gov, NCT01151982. Registered on June 29, 2010. [ABSTRACT FROM AUTHOR]

Behaviour change communication (BCC) can improve infant and young child nutrition (IYCN) knowledge, practices, and health outcomes. However, few studies have examined whether the improved knowledge persists after BCC activities end. This paper assesses the effect of nutrition sensitive social protection interventions on IYCN knowledge in rural Bangladesh, both during and after intervention activities. We use data from two, 2-year, cluster randomised control trials that included nutrition BCC in some treatment arms. These data were collected at intervention baseline, midline, and endline, and 6-10 months after the intervention ended. We analyse data on IYCN knowledge from the same 2,341 women over these 4 survey rounds. We construct a number correct score on 18 IYCN knowledge questions and assess whether the impact of the BCC changes over time for the different treatment groups. Effects are estimated using ordinary least squares accounting for the clustered design of the study. There are 3 main findings: First, the BCC improves IYCN knowledge substantially in the 1st year of the intervention; participants correctly answer 3.0-3.2 more questions (36% more) compared to the non-BCC groups. Second, the increase in knowledge between the 1st and 2nd year was smaller, an additional 0.7-0.9 correct answers. Third, knowledge persists; there are no significant decreases in IYCN knowledge 6-10 months after nutrition BCC activities ended. [ABSTRACT FROM AUTHOR]

Background: Recruitment of participants is particularly challenging in primary care, with less than a third of randomised controlled trials (RCT) achieving their target within the original time frame. Participant identification, consent, randomisation and data collection can all be time-consuming. Trials recruiting an incident, as opposed to a prevalent, population may be particularly affected. This paper describes the impact of a deferred recruitment model in a RCT of antibiotics for children with infected eczema in primary care, which required the recruitment of cases presenting acutely.Methods: Eligible children were identified by participating general practitioners (GPs) and referred to a study research nurse, who then visited them at home. This allowed the consent and recruitment processes to take place outside the general practice setting. Information was recorded about patients who were referred and recruited, or if not, the reasons for non-recruitment. Data on recruitment challenges were collected through semi-structured interviews and questionnaires with a sample of participating GPs. Data were thematically analysed to identify key themes.Results: Of the children referred to the study 34% (58/171) were not recruited - 48% (28/58) because of difficulties arranging a baseline visit within the defined time frame, 31% (18/58) did not meet the study inclusion criteria at the time of nurse assessment, and 21% (12/58) declined participation. GPs had positive views about the recruitment process, reporting that parents valued and benefitted from additional contact with a nurse. GPs felt that the deferred recruitment model did not negatively impact on the study.Conclusions: GPs and parents recognised the benefits of deferred recruitment, but these did not translate into enhanced recruitment of participants. The model resulted in the loss of a third of children who were identified by the GP as eligible, but not subsequently recruited to the study. If the potential for improving outcomes in primary care through complex studies is to be realised, new approaches to recruitment into primary care trials need to be developed and evaluated.Trial Registration: International Standard Randomised Controlled Trials, ISRCTN96705420 . Registered on 27 June 2012. [ABSTRACT FROM AUTHOR]

Background: Utilizing the objective structured clinical examination (OSCE) ensures objectivity when it comes to the assessment of nursing students' skills and competency. However, one challenge in OSCE integration is rater and examinee training and orientation. Aim: This study employed a quasi-experimental design to evaluate the effectiveness of different instructional methodologies in training and preparing raters and examinees for the OSCE. Methods: Participants were divided into three group of training methodologies: online, simulation, and traditional lecture (six raters and 18 examinees were assigned to each group). A total of 18 raters and 54 examinees partook. Results: The study found that raters trained through simulation exhibited a slight agreement with their rates, compared to those who were trained online and in traditional lectures. Moreover, examinees who were trained through the simulation methodology performed better compared to those trained via the other methodologies. Conclusions: The study findings indicate that using simulation by training raters and examinees in the OSCE is the most effective approach. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effects of combining a Pilates program with photobiomodulation therapy (PBMT) in patients with chronic nonspecific low back pain (CNLBP). Methods: Thirty-eight adults with CNLBP were randomly assigned to two groups: Pilates exercise + active PBMT (PIL + PBMT) or Pilates exercise + sham PBMT (PIL + SHAM). Both groups performed an 8-week mat Pilates program and received PBMT on their lumbar muscles 10 min before and after each session. The following variables were assessed before and after intervention: peak pain intensity, postural balance (i.e., center of the pressure [A-COP], velocity anteroposterior [Vel AP], and velocity mediolateral [Vel ML]), perceived disability (i.e., Oswestry Disability Index [ODI] and Roland Morris Disability Questionnaire [RMDQ]), and pain-related fear of movement (i.e., Tampa Scale of Kinesiophobia [TSK], Fear Avoidance Beliefs Questionnaire [FABQ], and Pain Catastrophizing Scale [PCS]). Results: Postural balance variables showed no statistically significant differences (p > 0.05) across time or between groups. The groups showed similar (p < 0.05) reductions in peak pain intensity, ODI, RMDQ, and PCS scores, but no statistically significant difference (p > 0.05) in TSK and FABQ scores. Conclusion: The mat Pilates program reduced peak pain intensity, perceived disability, and pain catastrophizing in adults with CNLBP, but PBMT had no additional effect on these variables. Mat Pilates alone or combined with PBMT was not able to improve postural balance. [ABSTRACT FROM AUTHOR]

Background: General practice is often recommended as an ideal setting to initiate advance care planning (ACP), but uptake of ACP in this setting is low. ACP-GP is a complex intervention to facilitate ACP for patients with chronic, life-limiting illness in Belgian general practice. It aims to increase patient ACP engagement and general practitioner (GP) ACP self-efficacy. In a cluster-randomized controlled trial, the intervention was not superior to control in increasing these outcomes. A parallel process evaluation aimed to enhance understanding of how the intervention was implemented, and which factors might have influenced trial results. Methods: We conducted a mixed-methods process evaluation following the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework. Data sources include recruitment and implementation monitoring, questionnaires for patients and GPs, and semi-structured (focus group) interviews with patients and GPs. Questionnaire data were analyzed descriptively. Qualitative data were first analyzed inductively; themes were then assigned deductively to RE-AIM dimensions. Results: Thirty-five GPs and 95 patients were recruited to the trial; GP reach was low. Sixteen GPs and 46 patients provided questionnaire data at 3 months post-baseline; qualitative data were transcribed for 14 GPs and 11 patients. Adoption of intervention components was moderate to good, with the exception of the documentation template for GPs. Interviews revealed varying patient attitudes towards ACP, but patients nonetheless emphasized that conversations made them feel reassured. GPs especially valued a positive framing of ACP. When adopted, the intervention was well-implemented and participant satisfaction was high. However, intention for maintenance was moderate, with GPs raising questions of how to sustainably implement ACP conversations in the future. Conclusions: Implementing the complex ACP-GP intervention in general practice is feasible, and can be successful. However, the implementation process is challenging and the sustainability is suboptimal. Our findings will guide future research and recommendations for facilitating and implementing ACP in general practice. Trial registration: ISRCTN12995230; prospectively registered on 19/06/2020. [ABSTRACT FROM AUTHOR]

Background: In recent years, an increasing number of studies have examined the potential efficacy of cognitive training procedures in individuals with normal ageing and mild cognitive impairment (MCI). Objective: The aims of this study were to (i) evaluate the efficacy of the cognitive Virtual Reality Rehabilitation System (VRRS) combined with anodal transcranial direct current stimulation (tDCS) applied to the left dorsolateral prefrontal cortex compared to placebo tDCS stimulation combined with VRRS and (ii) to determine how to prolong the beneficial effects of the treatment. A total of 109 subjects with MCI were assigned to 1 of 5 study groups in a randomized controlled trial design: (a) face-to-face (FTF) VRRS during anodal tDCS followed by cognitive telerehabilitation (TR) (clinic-atDCS-VRRS+Tele@H-VRRS); (b) FTF VRRS during placebo tDCS followed by TR (clinic-ptDCS-VRRS+Tele@H-VRRS); (c) FTF VRRS followed by cognitive TR (clinic-VRRS+Tele@H-VRRS); (d) FTF VRRS followed by at-home unstructured cognitive stimulation (clinic-VRRS+@H-UCS); and (e) FTF cognitive treatment as usual (clinic-TAU). Results: An improvement in episodic memory was observed after the end of clinic-atDCS-VRRS (p < 0.001). We found no enhancement in episodic memory after clinic-ptDCS-VRRS or after clinic-TAU. Moreover, the combined treatment led to prolonged beneficial effects (clinicatDCS- VRRS+Tele@H-VRRS vs. clinic-ptDCS-VRRS+Tele@H-VRRS: p = 0.047; clinic-atDCS-VRRS+Tele@H-VRRS vs. clinic-VRRS+Tele@H-VRRS: p = 0.06). Discussion: The present study provides preliminary evidence supporting the use of individualized VRRS combined with anodal tDCS and cognitive telerehabilitation for cognitive rehabilitation. [ABSTRACT FROM AUTHOR]

Background and objectives: Considering the significant prevalence of ileus after abdominal surgery and the beneficial effects of Cuminum cyminum in digestive problems, this study aimed to examine whether Cuminum cyminum has any effect on the return of bowel motility after abdominal surgery. Materials and methods: In this triple-blind clinical trial study, 74 patients undergoing abdominal surgery were assigned to the intervention and control groups using minimization methods. The patients in the intervention group consumed 250 mg capsules containing Cuminum cyminum extract 4 h after the surgery and another dose of the drug 1 h afterward. The patients in the control group consumed a 250 mg capsule containing starch as a placebo at hours similar to those in the intervention group. The instruments used to collect the data were a demographic questionnaire and a researcher-made checklist to assess bowel habits. The data were analyzed using SPSS-22 software. Results: The average time of gas passing in the intervention and control groups was 9.03 ± 3.41 and 11.72 ± 4.21 h, respectively. The defecation times in the intervention and control groups were 16.97 ± 5.02 and 26 ± 9.87 h, showing a significant difference between the two groups as indicated by the independent samples T-test (P > 0.001). Furthermore, abdominal pain, abdominal bloating, nausea, and vomiting were significantly less frequent in the intervention group compared to the control group as confirmed by Fisher's exact test (P > 0.001). Conclusion: According to the results, the consumption of Cuminum cyminum after abdominal surgery helps to reduce the time of gas passing, defecation, and the return of bowel motility. However, additional studies need to address the effectiveness of Cuminum cyminum by changing the time and duration of its use. [ABSTRACT FROM AUTHOR]

Purpose: The rapid and limitless outbreak of the coronavirus in 2019 caused athletes to quarantine in their homes, resulting in stress and anxiety and the experience of negative symptoms, such as sleep disorder. The present study aims to investigate the effect of 8 weeks of yoga exercise on athletes' anxiety and... [ABSTRACT FROM AUTHOR]

Introduction: Diagnosing and performing timely treatment for lung diseases is crucial for saving patients' lives. This study aims to investigate the effect of online gamification on nursing students' learning of lung diseases, lung sounds, and self-efficacy. Material & Methods: This semi-experimental study involved 68 sixth-semester nursing students, selected through convenient sampling and randomly allocated to control and intervention groups using dice throws. Over three weekly sessions, the intervention group received training on lung diseases and lung sounds via the Storyline platform and gamification through Kahoot, while the control group received the same content through lectures by the same instructor. Questionnaires assessing demographics, learning outcomes, and self-efficacy were administered before and two weeks after the intervention. Data were analyzed using Chi-square, independent t-tests, paired t-tests, and Kolmogorov-Smirnov tests in SPSS v.16, with a significance level of 0.05. Results: The participants had a mean age of 22.73 ± 1.29 years, and 63% were male. There were no significant differences between the two groups in learning assessment and self-efficacy before the intervention (P=0.193 and P=0.167, respectively). After the intervention, the intervention group showed a statistically significant improvement in learning assessment scores (P=0.031, 16.55±2.57) compared to the control group (P=0.086, 9.11±1.01). Similarly, self-efficacy scores in the intervention group (P=0.023, 65.29±3.97) were significantly higher than in the control group (P=0.084, 48.18±5.36). Conclusion: Online gamification significantly improves the learning of lung diseases, lung sounds, and self-efficacy in nursing students. [ABSTRACT FROM AUTHOR]

Background: Social prescribing link workers are non-health or social care professionals who connect people with psychosocial needs to non-clinical community supports. They are being implemented widely, but there is limited evidence for appropriate target populations or cost effectiveness. This study aimed to explore the feasibility, potential impact on health outcomes and cost effectiveness of practice-based link workers for people with multimorbidity living in deprived urban communities. Methods: A pragmatic exploratory randomised trial with wait-list usual care control and blinding at analysis was conducted during the COVID 19 pandemic (July 2020 to January 2021). Participants had two or more ongoing health conditions, attended a general practitioner (GP) serving a deprived urban community who felt they may benefit from a one-month practice-based social prescribing link worker intervention.. Feasibility measures were recruitment and retention of participants, practices and link workers, and completion of outcome data. Primary outcomes at one month were health-related quality of life (EQ-5D-5L) and mental health (HADS). Potential cost effectiveness from the health service perspective was evaluated using quality adjusted life years (QALYs), based on conversion of the EQ-5D-5L and ICECAP-A capability index to utility scoring. Results: From a target of 600, 251 patients were recruited across 13 general practices. Randomisation to intervention (n = 123) and control (n = 117) was after baseline data collection. Participant retention at one month was 80%. All practices and link workers (n = 10) were retained for the trial period. Data completion for primary outcomes was 75%. There were no significant differences identified using mixed effects regression analysis in EQ-5D-5L (MD 0.01, 95% CI -0.07 to 0.09) or HADS (MD 0.05, 95% CI -0.63 to 0.73), and no cost effectiveness advantages. A sensitivity analysis that considered link workers operating at full capacity in a non-pandemic setting, indicated the probability of effectiveness at the €45,000 ICER threshold value for Ireland was 0.787 using the ICECAP-A capability index. Conclusions: While the trial under-recruited participants mainly due to COVID-19 restrictions, it demonstrates that robust evaluations and cost utility analyses are possible. Further evaluations are required to establish cost effectiveness and should consider using the ICE-CAP-A wellbeing measure for cost utility analysis. Registration: This trial is registered on ISRCTN. Title: Use of link workers to provide social prescribing and health and social care coordination for people with complex multimorbidity in socially deprived areas. Trial ID: ISRCTN10287737. Date registered 10/12/2019. Link: https://www.isrctn.com/ISRCTN10287737 [ABSTRACT FROM AUTHOR]

Sarcopenia is defined by the presence of decreased skeletal muscle mass, strength, and functionality in older people. Multicomponent interventions represent an alternative to non-pharmacological treatment for preventing disease progression. This study aimed to evaluate the effects of a multicomponent intervention approach in women at risk of sarcopenia. Methods: A quasi-experimental pilot study of 12 weeks was conducted, with 24 sessions of dancing and resistance exercises and 12 sessions of nutritional education. The outcomes were changes in muscle mass, grip strength, gait speed, and body composition. The project was registered on Clinical Trials: NCT06038500 (14 September 2023). Results: Twelve women aged 55–75 years participated in this study; after the intervention, changes were found in the following variables: grip strength, from 18.70 (17.98–19.23) at baseline to 21.57 (20.67–23.16) kg (p = 0.002); gait speed, from 0.95 (0.81–1.18) at baseline to 1.34 (1.20–1.47) m/s (p = 0.003); and hip circumference, from 99.75 (94.75–110.37) at baseline to 97.65 (93.92–109.50) cm (p = 0.023). Other measurements that appeared without changes were appendicular skeletal muscle mass, from 21.17 (18.58–22.33) at baseline to 20.77 (18.31–22.39) kg (p = 0.875), and the appendicular skeletal muscle mass index, from 8.64 (8.08–9.35) at baseline to 8.81 (7.91–9.38) kg/m2 (p = 0.875) after the intervention. Conclusions: The three-month multicomponent intervention in women at risk of sarcopenia improved their grip strength and gait speed. [ABSTRACT FROM AUTHOR]

Background: Palmitoylethanolamide (PEA) has analgesic/anti-inflammatory properties that may be a suitable alternative to over-the-counter (OTC) non-steroidal analgesics/anti-inflammatories. While OTC pain medications can impair strength training adaptations, the mechanism of action of PEA is distinct from these and it may not negatively affect skeletal muscle adaptations to strength training. Methods: The primary aim of this study was to investigate the effects of daily PEA supplementation (350 mg Levagen + equivalent to 300 mg PEA) combined with 8-weeks of resistance training on lean body mass with secondary aims addressing strength, power, sleep, and wellbeing compared to placebo (PLA) in young, healthy, active adults. In a randomized, controlled, double-blinded trial, 52 untrained, recreationally active participants aged 18–35 y were allocated to either the PEA or PLA groups. Participants consumed either 2 × 175 mg Levagen + PEA or identically matched maltodextrin capsules during an 8-week period of whole-body resistance training. This trial assessed the pre- to post- changes in total and regional lean body mass, muscular strength (1-RM bench, isometric mid-thigh pull), muscular power [countermovement jump (CMJ), bench throw], pain associated with exercise training, sleep, and wellbeing compared with the PEA or PLA condition. Results: 48 Participants were included in the final intention to treat (ITT) analysis and we also conducted per protocol (PP) analysis (n = 42). There were no significant between-group differences for total or regional lean muscle mass post-intervention. There was a significantly higher jump height (CMJ) at week 10 in the PEA group compared to the PLA (Adjusted mean difference [95% CI] p-value; ITT: − 2.94 cm [− 5.15, − 0.74] p = 0.010; PP: − 2.93 cm [− 5.31, − 0.55] p = 0.017). The PLA group had higher 1-RM bench press post-intervention compared with the PEA group (ITT: 2.24 kg [0.12, 4.37] p = 0.039; PP: 2.73 kg [0.40, 5.06] p = 0.023). No significant treatment effects were noted for any of the other outcomes. Conclusion: PEA supplementation, when combined with 8 weeks of strength training, did not impair lean mass gains and it resulted in significantly higher dynamic lower-body power when compared with the PLA condition. Trial Registration: Australian New Zealand Clinical Trials Registry (ANZCTR: ACTRN12621001726842p). Key Findings: Palmitoylethanolamide (PEA) is a compound that works as an anti-inflammatory and analgesic for the management of pain that works on different biochemical pathways compared to other over-the-counter analgesics and non-steroidal anti-inflammatories. Our findings indicate that a daily dose of 300 mg of PEA administered during 8-weeks of strength training did not interfere with skeletal muscle hypertrophy gains and may improve lower body power (e.g., jump height) compared to the placebo group. PEA may fill the gap for athletes and the active population as an alternative method of pain management. [ABSTRACT FROM AUTHOR]

Introduction: In recent decades, E-learning has gained widespread recognition globally as a vital application of information and communication technology. Objectives: The present study investigated the effectiveness of non-attendance triage training based on the ESI-IV system on the knowledge and ability of pre-hospital emergency staff. Patients and Methods: This study was a semi-experimental interventional study, and the study population consisted of the pre-hospital emergency staff of Ahvaz university of medical sciences academic hospitals in 2021. The study tool was a questionnaire on the awareness and performance of the triage system of hospital emergency (ESI). Initially, both questionnaires were completed, and submitted the triage training file to the intervention group. Two weeks after the first phase—completion of the questionnaire for the first time— and the study of the file by the subjects, the questionnaire was completed again by the intervention group, and the data of both groups were compared. Results: According to the results, the mean of awareness and decision-making in the control group before and after the intervention was (11.8, 10.85, and 13.82) and (7.51, 7.36, and 8.86) respectively. The results indicate that non-attendance triage training based on the ESI-IV system was effective in the knowledge and ability of the pre-hospital emergency personnel had a positive and significant impact, and remains at a good level. Conclusion: The present results of the research indicate that the use of non-attendance training as an effective method can improve interns’ knowledge and ability. [ABSTRACT FROM AUTHOR]

Volunteer interventions play a vital role in supporting families by offering accessible and community-based resources outside the formal professional sector. This study examines the impact of the volunteer intervention known as Family Club Denmark (FCD) on the well-being of parents and children. FCD aims to provide families with positive experiences and support relationship building. The intervention, open to families from diverse social backgrounds, comprises volunteer-led family clubs where parents and children aged 2–12 years engage in activities and meals. We allocated 510 families (363 vulnerable families) to FCD or placed them on a waiting list based on a first-come, first-served principle. We conducted baseline, post-intervention, and follow-up assessments through questionnaires, observations, and interviews. On average, families participated in 5.8 sessions, with both families and volunteers reporting high satisfaction. When compared to control families, we find that vulnerable FCD parents feel more confident playing with their children (p = 0.04, [0.01; 0.40], d = 0.25), require less assistance in playing with their children (p = 0.01, [−0.34; −0.05], d = 0.33), and report that their children have a more challenging time forming friendships (p = 0.01, [−0.51; −0.09], d = 0.29). However, we did not find significant effects on mental health, parenting stress, self-efficacy, self-worth, family routines, or child well-being. We observed similar results for the full sample. The discovery that parents feel more confident playing with their children after participating in FCD highlights the vital role of volunteer-based interventions in enhancing parental engagement and fostering positive parent–child interactions. Trial registration: ClinicalTrials.gov NCT03657888 (registered 29 August 2018). [ABSTRACT FROM AUTHOR]

Muscle strength declines ~3% per year after the age of 70. Resistance training guidelines for older adults are often based on free-weight and machine exercises, which may be inaccessible and lack carryover to activities of daily living. We tested the hypothesis that resistance training adaptations in older adults are task-specific. Thirty adults (8 males, 22 females; mean age = 71 years) were randomly assigned to participate in 6 weeks of supervised, high-intensity resistance training (twice per week) utilizing free-weight and machine exercises (traditional) versus functional activities that were overloaded with a weighted vest (functional). Participants were thoroughly familiarized with the exercises and testing prior to beginning the study. Major outcome measures included assessments of functional performance, five-repetition maximum strength, isometric knee extensor force, and quadriceps muscle size. Physical activity and nutrition were monitored. The study results demonstrate that the magnitude of improvement within a given outcome was largely dependent on group assignment, with greater improvements in gait speed and the timed-up-and-go in the functional group, but 2-3x greater five repetition maximum strength improvements for the trap bar deadlift, leg press, and leg extension following traditional resistance training. Both groups showed improvements in isometric knee extensor force and muscle size, suggesting that some aspects of the observed adaptations were generic, rather than specific. Overall, these novel findings suggest that, among older adults, 1) resistance training adaptations exhibit a high degree of task specificity and 2) significant improvements in functional outcomes can be achieved with the use of a weighted vest. [ABSTRACT FROM AUTHOR]

Background: This study aimed to demonstrate the efficacy of erbium, chromium-doped:yttrium, scandium, gallium, and garnet (Er,Cr:YSGG) laser-assisted nonsurgical periodontal therapy in periodontitis patients during 8 weeks of healing. Methods: A split-mouth, single-blinded, randomized controlled clinical trial was conducted on 12 patients diagnosed with stage III/IV periodontitis and had a minimum of two teeth with probing pocket depth (PPD) > 5 mm in at least two quadrants. Upon randomization, each quadrant was assigned for conventional scaling and root planing (SRP) procedure or laser-assisted therapy (SRP + laser) using radial firing tip (RFPT 5, Biolase). Clinical measurements and gingival crevicular fluid collection were performed for statistical analysis. Results: In the initial statistical analysis on the whole subject teeth, modified gingival index (MGI) reduction was greater in test group at 1(P = 0.0153), 4 (P = 0.0318), and 8 weeks (P = 0.0047) compared to the control in the same period. PPD reduction at 4 weeks in test group was -1.67 ± 0.59 showing significant difference compared to the control (-1.37 ± 0.63, P = 0.0253). When teeth with mean PPD ≥5 mm were sorted, MGI decrease was significantly greater in test group at 1 (P=0.003) and 8 week (P=0.0102) follow-ups. PPD reduction was also significantly greater in test group at 4 week period (-1.98 ± 0.55 vs -1.58 ± 0.56, test vs control, P=0.0224). Conclusions: Er,Cr:YSGG-assisted periodontal therapy is beneficial in MGI and PPD reductions during early healing period. [ABSTRACT FROM AUTHOR]

Background: This study aimed to compare the efficacy of intra-articular prolotherapy (IG) combined with peri-articular perineural injection (PG) in the management of knee osteoarthritis (KOA). Methods: A total of 60 patients with the diagnosis of KOA were included in this double-blinded randomized controlled clinical trials. The inclusion criteria were as follow: (1) 48–80 years old; (2) the diagnose of KOA; (3) the grade 2 and 3 of the Kellgern–Lawrence grading scale; (4) the pain, crepitation, and knee joint stiffness continuing for 3 months at least. The main exclusion criteria were as follow: (1) any infection involving the knee skin; (2) history of any Influencing factors of disease. All patients were divided into three groups and received either IG, PG and I + PG under the ultrasound guidance and the 2, 4 and 8 weeks follow-up data of patients were available. (IG n = 20 or PG n = 20, I + PG n = 20). Visual Analogue Scale (VAS), The Western Ontario McMaster University Osteoarthritis Index (WOMAC) and the pressure pain threshold (PPT) were used as outcome measures at baseline, 2, 4 and 8 weeks. Results: There were no statistically significant differences in terms of age, sex, BMI, duration of current condition and baseline assessments of pain intensity, WOMAC scores and PPT. After treatment, the improvement of VAS activity, WOMAC and PPT values was showed compared with pre-treatment in all groups (p < 0.05). At 4 and 8 weeks after treatment, the VAS and WOMAC scores of the I + PG were significantly lower than those of the PG or IG, and the difference was statistically significant (p < 0.05). The PPT values of PG and I + PG were significantly improved compared to IG at 2, 4, and 8 weeks after treatment. Conclusion: The ultrasound guided I + PG of 5% glucose seem to be more effective to alleviate pain and improve knee joint function than single therapy in short term. Clinical rehabilitators could clinically try this combination of I + PG to improve clinical symptoms in patients with KOA. [ABSTRACT FROM AUTHOR]

Objective: The aim of this study was to evaluate the use of after‐visit instructions (AVIs) in an academic rheumatology clinic and assess the impact of standardized AVIs (sAVIs) and teach‐back (TB) on comprehension of health information. Methods: A retrospective review of adult patients seen between October 1 and 8, 2021, at the rheumatology clinic collected data on patient demographics, clinical features, and the presence, content, and readability of AVIs. During a subsequent prospective proof‐of‐concept study, routinely scheduled patients seen at the rheumatology clinic were randomized into three groups: control (received standard of care), received sAVIs only, and received sAVIs plus TB. Patients completed a health literacy questionnaire, satisfaction survey, and a one‐ to two‐week postvisit telephone survey to assess AVI comprehension. Results: Out of 316 retrospective patient visits, 82 (25.9%) received AVIs. Among 210 of 316 patients (66.5%) with management changes, 76 (36.1%) received AVI, with 74.2% of the instructions considered concordant with the provider's note. Use of AVIs was higher with management changes, new patient visits, and medical trainee/teaching clinics. AVIs were written at a median 6.8 grade level. A total of 75 patients completed the prospective study: 31 (41.3%) were in the control group, 19 (25.3%) were in the group that received sAVIs only, and 25 (33.3%) were in the group that received AVIs with TB. There were no differences in overall postvisit survey comprehension/retention scores among the three patient groups evaluated. Conclusion: Although a lack of AVI use was identified, implementation of sAVIs did not appear to impact patient retention or comprehension of discharge health information. [ABSTRACT FROM AUTHOR]

Background: Many community-based self-management programs have been developed for older adults with type-2 diabetes mellitus (T2DM), bolstered by evidence from randomized controlled trials (RCTs) that T2DM can be prevented and managed through lifestyle modifications. However, the evidence for their effectiveness is contradictory and weakened by reliance on single-group designs and/or small samples. Additionally, older adults with multiple chronic conditions (MCC) are often excluded because of recruiting and retention challenges. This paper presents a protocol for a two-armed, multisite, pragmatic, mixed-methods RCT examining the effectiveness and implementation of the Aging, Community and Health Research Unit-Community Partnership Program (ACHRU-CPP), a new 6-month interprofessional, nurse-led program to promote self-management in older adults (aged 65 years or older) with T2DM and MCC and support their caregivers (including family and friends).Methods/design: The study will enroll 160 participants in two Canadian provinces, Ontario and Alberta. Participants will be randomly assigned to the control (usual care) or program study arm. The program will be delivered by registered nurses (RNs) and registered dietitians (RDs) from participating diabetes education centers (Ontario) or primary care networks (Alberta) and program coordinators from partnering community-based organizations. The 6-month program includes three in-home visits, monthly group sessions, monthly team meetings for providers, and nurse-led care coordination. The primary outcome is the change in physical functioning as measured by the Physical Component Summary (PCS-12) score from the short form-12v2 health survey (SF-12). Secondary client outcomes include changes in mental functioning, depressive symptoms, anxiety, and self-efficacy. Caregiver outcomes include health-related quality of life and depressive symptoms. The study includes a comparison of health care service costs for the intervention and control groups, and a subgroup analysis to determine which clients benefit the most from the program. Descriptive and qualitative data will be collected to examine implementation of the program and effects on interprofessional/team collaboration.Discussion: This study will provide evidence of the effectiveness of a community-based self-management program for a complex target population. By studying both implementation and effectiveness, we hope to improve the uptake of the program within the existing community-based structures, and reduce the research-to-practice gap.Trial Registration: ClinicalTrials.gov, Identifier: NCT02158741 . Registered on 3 June 2014. [ABSTRACT FROM AUTHOR]