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This study examined whether participants with poor activities of daily living (ADLs) at hospital discharge had increased weight loss after 6 months of follow-up and whether nutrition therapy can prevent this weight loss. This dietary randomized controlled trial (N = 104) examined community-dwelling older adults (66–95 years) discharged from hospital and at risk for malnutrition, receiving either 6 months of nutrition therapy (intervention) or only standard care (control). ADL was assessed using seven questions on self-care based on the Katz et al.'s method. At discharge, 45 (43%), 36 (35%), and 23 (22%) had high, medium, and poor ADL, respectively, with no differences between the control and intervention groups according to chi-square test. Participants in the control group with poor ADL had significantly higher weight loss than participants with high ADL (age- and sex-adjusted analysis of covariance: 3.6 kg; 95% confidence interval [1.0, 6.1] kg, p =.007). No such difference was observed in the intervention group. Participants with poor ADL at hospital discharge develop lower body weight by around 3.5 kg 6 months later when compared with participants with high ADL. Receiving nutrition therapy could help older adults with poor ADL to maintain body weight after hospital discharge. [ABSTRACT FROM AUTHOR]

Abstract Obesity and overweight are major health concerns, with a 19.7% prevalence among Malaysian adults, as reported in the 2019 National Health and Morbidity Survey. This study assessed the effectiveness of an educational intervention on weight control intention using the Health Belief Model (HBM). A quasi-experimental design was employed, involving 140 participants equally divided into an intervention group (IG) and a control group (CG). Post-intervention, the IG showed significant improvement in perceived self-efficacy in dieting (mean score 3.96 ± 0.85) compared to the CG (3.76 ± 0.86, p = 0.003). Perceived self-efficacy in exercise also increased in the IG (4.12 ± 0.52) compared to the CG (3.51 ± 0.94, p

Introduction: Early marriages, early childbirth, low BMI and high incidence of anaemia are known factors for high maternal mortality among tribal pregnant women. MATERIALS AND METHODS: This was a mixed method study (qualitative and quantitative) undertaken to evaluate educational intervention package among tribal pregnant women in Chittoor District of Andhra Pradesh State in South India. A baseline household survey with the help of a semi-structured questionnaire was conducted in both intervention group (n = 109) and control group (n = 119) of ST habitations. An educational intervention was implemented through health education approach to bring about awareness and behavioural change among pregnant women regarding healthcare practices and utilization of health services. Qualitative data collection tool included semi-structured FGD. Quantitative data was analysed using SPSS version 26.0. Content analysis was done for qualitative data. Results: The findings of this study show that awareness and utilization with respect to various services facilitated by ASHAs, ANMs and medical officers are improved postintervention among tribal pregnant women, and the various reasons for non-utilization of services were lack of awareness, long distance of health facility, no transportation, poor socio-economic status, inadequate facilities at PHC, etc., Conclusion: This study shows that intervention to improve awareness and health services utilization, and continuous health education should be imparted to all the pregnant mothers. For this healthcare providers like ASHA and ANM and medical officers should be trained and motivated to educate the community.

This pilot study assessed text messaging as an early intervention for preventing pressure ulcers (PrUs) in individuals with spinal cord injury (SCI) post-hospital discharge. Thirty-nine wheelchair-users discharged after acquiring a SCI, underwent randomisation into an intervention group (n = 20) with text messages and a control group (n = 19). All participants received standard post-discharge care and completed a skincare questionnaire before and 6-month after discharge. Primary outcomes included feasibility and acceptability of early intervention using text messaging, alongside performance, concordance, and attitudes toward skincare. Secondary outcomes measured perception and the incidence of PrUs. Baseline demographics were comparable between the intervention and control groups. Eight of 20 participants completed 6-month follow-up questionnaires in the intervention group, six participants completed the 6-month questionnaires in the control group,. Participants expressed high satisfaction with text messages, understanding of content, and increased confidence in preventing PrUs. At 6-month post-discharge, the intervention group showed improved prevention practices, heightened awareness of PrU risks, and increased perceived importance of prevention, which were not observed in the control group. However, there were no significant differences in PrU incidence, possibly due to the small sample size and short follow-up. The study demonstrates that using text messaging as an early intervention for PrU prevention in individuals with SCI is feasible and well-received. Preliminary results suggest a positive impact on participants' attitudes and practices, indicating the potential of text messaging to reduce PrU incidence. However, further research with larger samples and extended follow-up is crucial to validate these promising initial findings. • This is the first study evaluating feasibility of text messagings for PrU prevention in spinal cord injury patients. • Participants were highly satisfied with receiving and understanding text messages, recommending them for PrU prevention. • Participants receiving messages showed improved practices, awareness, and reduced barriers of PrU prevention post-discharge. • If future larger studies show significant results, this intervention could be a valuable tool in community healthcare. [ABSTRACT FROM AUTHOR]

Background/Objectives: This study aimed to evaluate the impact of a bundle of interventions on the error rates in preparing parenteral medications in a neonatal and pediatric intensive care unit (NICU/PICU). Methods: We conducted a prospective interventional study in a NICU/PICU in a tertiary university hospital as a follow-up to a prior study in the same setting. A clinical pharmacist and a pharmacy technician (PT) analyzed the workflow of drug preparation on the ward, identified high-alert medications, and defined a bundle of five interventions, which include the following: Drug Labeling: 1. EN ISO-DIVI labeling; Training: 2. Standardized preparation process on the ward; 3. eLearning Program; 4. Expert Consultations; and Location of Preparation: 5. Transfer of the preparation of high-alert medications and standardized preparations to the central pharmacy. After implementing the bundle of interventions, we observed the preparation process on the ward to evaluate if the implementation of the interventions had an impact on the quality of the drug preparation. Results: We observed 262 preparations in the NICU/PICU. Each single step of the preparation process was defined as an error opportunity. We defined seven error categories with an overall error opportunity of 1413. In total, we observed 11 errors (0.78%). The reduction in the overall error rate from 1.32% in the former study to 0.78% per preparation opportunity demonstrated that the implemented interventions were effective in enhancing medication safety. Conclusions: This study provides evidence that a bundle of interventions, including standardizing drug labeling, enhancing training, and centralizing the preparation of high-alert medications, can reduce medication errors in NICU/PICU settings. [ABSTRACT FROM AUTHOR]

Antioxidant intake may contribute to the prevention of numerous diseases, particularly those related to stress-induced psychiatric and stress disorders. The current study aimed to assess the relationship between daily antioxidant intake (DAI) and Generalized Anxiety Disorder (GAD) in adults. It also sought to investigate the correlation between the type of diet in conjunction with DAI and the scores on GAD 7-Item Scale in adults. A cross-sectional design was used to examine if DAI was lower in individuals with GAD; followed by an interventional study of 40 adults with severe GAD, who were exposed to higher DAI for a period of 6 weeks. The results indicated that participants with severe GAD had significantly lower levels of DAI compared to healthy controls (p < 0.001). After 6 weeks of antioxidant supplementation, a significant decrease in GAD-7 scores of participants was observed (p < 0.001). The study found a significant negative relationship between DAI and GAD. [ABSTRACT FROM AUTHOR]

ABSTRACT: Introduction: Early marriages, early childbirth, low BMI and high incidence of anaemia are known factors for high maternal mortality among tribal pregnant women. Materials and Methods: This was a mixed method study (qualitative and quantitative) undertaken to evaluate educational intervention package among tribal pregnant women in Chittoor District of Andhra Pradesh State in South India. A baseline household survey with the help of a semi-structured questionnaire was conducted in both intervention group (n = 109) and control group (n = 119) of ST habitations. An educational intervention was implemented through health education approach to bring about awareness and behavioural change among pregnant women regarding healthcare practices and utilization of health services. Qualitative data collection tool included semi-structured FGD. Quantitative data was analysed using SPSS version 26.0. Content analysis was done for qualitative data. Results: The findings of this study show that awareness and utilization with respect to various services facilitated by ASHAs, ANMs and medical officers are improved postintervention among tribal pregnant women, and the various reasons for non-utilization of services were lack of awareness, long distance of health facility, no transportation, poor socio-economic status, inadequate facilities at PHC, etc., Conclusion: This study shows that intervention to improve awareness and health services utilization, and continuous health education should be imparted to all the pregnant mothers. For this healthcare providers like ASHA and ANM and medical officers should be trained and motivated to educate the community. [ABSTRACT FROM AUTHOR]

Background: Perinatal death auditing is useful to identify preventable perinatal deaths and avoidable/preventable factors. Objectives: To know the impact of perinatal death audit like 1). Documentation of Care Provided 2) Changes in Infrastructure and Facilities 3). Number of perinatal deaths 4) Any other impact. Methodology: Perinatal death auditing project implemented in two districts of Karnataka state. As a Part of Intervention, Expert Panel audited the perinatal deaths and provided feedback to the hospitals where these deaths occurred. The feedback included issues identified and suggestion for prevention. Trained Medical-Social Workers conducted evaluation surveys in post-interventional period at 6th monthly intervals. They collected the filled tools from the hospitals and handed over the written feedback of the expert panel to these hospitals. It was anticipated that the process of feedback would initiate some changes in infrastructure, facilities, documentation and number of perinatal deaths. Results: Number of reported perinatal deaths decreased in Koppal District (from 325 to 301) as compared with Dakshina Kannada (from 223 to 221). Improvements in: 1]. Documentation of care provided 2] Assertion of preventability by the doctors 3] Infrastructure &facilities were observed in backward district of Koppal as compared to developed district of Dakshina Kannada. Conclusion: Perinatal Death Auditing reduces the number of perinatal deaths apart from improving documentation, assertion of preventability by doctors, infrastructure & facilities.

Purpose In a prospective open study, with intervention, conducted in Primary Health Care Units by General Practitioners (GPs) in Portugal, the effectiveness of a single pill of candesartan/amlodipine (ARB/amlodipine), as the only anti-hypertension (anti-HTN) medication, in adult patients with uncontrolled HTN (BP > 140/or > 90 mm Hg), either previously being treated with anti-HTN monotherapies (Group I), or combinations with hydrochlorothiazide (HCTZ) (Group II), or not receiving medication at all (Group III), was evaluated across 12-weeks after implementation of the new therapeutic measure.Materials and methods A total of 118 GPs recruited patients with uncontrolled HTN who met inclusion/exclusion criteria. Participants were assigned, according to severity, one of 3 (morning) fixed combination candesartan/amlodipine dosage (8/5 or 16/5 or 16/10 mg/day) and longitudinally evaluated in 3 visits (v0, v6 and v12 weeks). Office blood pressure was measured in each visit, and control of HTN was defined per guidelines (BP< 140/90 mmHg).Results Of the 1234 patients approached, 752 (age 61 ± 10 years, 52% women) participated in the study and were assigned to groups according to previous treatment conditions. The 3 groups exhibited a statistically significant increased control of blood pressure after receiving the fixed combination candesartan/amlodipine dosage. The overall proportion of controlled HTN participants increased from 0,8% at v0 to 82% at v12. The mean arterial blood pressure values decreased from SBP= 159.0 (± 13.0) and DBP= 91.1 (± 9.6) at baseline to SBP= 132,1 (± 11.3) and DBP= 77,5 (± 8.8) at 12 weeks (p

Purpose: In a prospective open study, with intervention, conducted in Primary Health Care Units by General Practitioners (GPs) in Portugal, the effectiveness of a single pill of candesartan/amlodipine (ARB/amlodipine), as the only anti-hypertension (anti-HTN) medication, in adult patients with uncontrolled HTN (BP > 140/or > 90 mm Hg), either previously being treated with anti-HTN monotherapies (Group I), or combinations with hydrochlorothiazide (HCTZ) (Group II), or not receiving medication at all (Group III), was evaluated across 12-weeks after implementation of the new therapeutic measure. Materials and methods: A total of 118 GPs recruited patients with uncontrolled HTN who met inclusion/exclusion criteria. Participants were assigned, according to severity, one of 3 (morning) fixed combination candesartan/amlodipine dosage (8/5 or 16/5 or 16/10 mg/day) and longitudinally evaluated in 3 visits (v0, v6 and v12 weeks). Office blood pressure was measured in each visit, and control of HTN was defined per guidelines (BP< 140/90 mmHg). Results: Of the 1234 patients approached, 752 (age 61 ± 10 years, 52% women) participated in the study and were assigned to groups according to previous treatment conditions. The 3 groups exhibited a statistically significant increased control of blood pressure after receiving the fixed combination candesartan/amlodipine dosage. The overall proportion of controlled HTN participants increased from 0,8% at v0 to 82% at v12. The mean arterial blood pressure values decreased from SBP= 159.0 (± 13.0) and DBP= 91.1 (± 9.6) at baseline to SBP= 132,1 (± 11.3) and DBP= 77,5 (± 8.8) at 12 weeks (p < 0.01). Results remained consistent when controlling for age and sex. Conclusion: In patients with uncontrolled HTN, therapeutic measures in accordance with guidelines, with a fixed combination candesartan/amlodipine, allowed to overall achieve HTN control at 12 weeks in 82% of previously uncontrolled HTN patients, reinforcing the advantages of these strategies in primary clinical practice. PLAIN LANGUAGE SUMMARY: What is the context? Arterial hypertension (HTN) represents the main risk factor for cause of death from cardiovascular disease (CV). Adequate control of hypertension reduces CV risk and significantly prevents CV events and associated morbidity and mortality. This requires patients' adherence and persistence in implemented treatment and the achievement of tension targets that are related to the reduction of CV risk. The latest international recommendations indicate that hypertension control is insufficient in most countries. In Portugal, hypertension control is <43% and a significant number of patients treated do not comply with the recommendations. What is new? In a prospective, interventional, and multicentre study, carried out by General Practitioners (GPs) in Primary Health Care Units across Portugal, the objective was to determine (i) whether the presence of uncontrolled hypertension results from non-compliance with the provisions of the recommendations and the Integrated Care Process (PAI) of the Direção Geral de Saúde (DGS), i.e. inappropriate use of monotherapies or inadequate low doses of combinations of antihypertensives, and (ii) whether the adjustment of hypertension therapies, favouring the schemes provided in the recommendations, allows adequate control of arterial hypertension, in previously uncontrolled patients, when these are closely monitored in a 12-week time period. What is the impact? When the guidelines' therapeutic protocol is followed, as established for each identified group of patients (monotherapy, hydrochlorothiazide, and no medication), results indicate a marked and statistically significant improvements in both SBP and DBP values and hypertension control across time. [ABSTRACT FROM AUTHOR]

Abstract Background To date, no disease modifying therapies are available for Parkinson’s disease (PD). Since PD is the second most prevalent neurodegenerative disorder, there is a high demand for such therapies. Both environmental and genetic risk factors play an important role in the etiology and progression of PD. The most common genetic risk factor for PD is a mutation in the GBA1(GBA)-gene, encoding the lysosomal enzyme glucocerebrosidase (GCase). The mucolytic ambroxol is a repurposed drug, which has shown the property to upregulate GCase activity in-vitro and in-vivo. Ambroxol therefore has the potency to become a disease modifying therapy in PD, which was the reason to design this randomized controlled trial with ambroxol in PD patients. Methods This trial is a single-center, double-blind, randomized, placebo-controlled study, including 80 PD patients with a GBA mutation, receiving either ambroxol 1800 mg/day or placebo for 48 weeks. The primary outcome measure is the Unified Parkinson’s Disease Rating Scale motor subscore (part III) of the Movement Disorder Society (MDS-UPDRSIII) in the practically defined off-state at 60 weeks (after a 12-week washout period). Secondary outcomes include a 3,4-dihydroxy-6-18F-fluoro-I-phenylalanine ([18F]FDOPA) PET-scan of the brain, Magnetic Resonance Imaging (with resting state f-MRI and Diffusion Tensor Imaging), GCase activity, both intra- and extracellularly, sphingolipid profiles in plasma, Montreal Cognitive Assessment (MoCA), quality of life (QoL) measured by the Parkinson’s Disease Questionnaire (PDQ-39) and the Non-Motor Symptom Scale (NMSS) questionnaire. Discussion Ambroxol up to 1200 mg/day has shown effects on human cerebrospinal fluid endpoints, which supports at least passage of the blood-brain-barrier. The dose titration in this trial up to 1800 mg/day will reveal if this dose level is safe and also effective in modifying the course of the disease. Trial registration NCT05830396. Registration date: March 20, 2023.

Background: To date, no disease modifying therapies are available for Parkinson's disease (PD). Since PD is the second most prevalent neurodegenerative disorder, there is a high demand for such therapies. Both environmental and genetic risk factors play an important role in the etiology and progression of PD. The most common genetic risk factor for PD is a mutation in the GBA1(GBA)-gene, encoding the lysosomal enzyme glucocerebrosidase (GCase). The mucolytic ambroxol is a repurposed drug, which has shown the property to upregulate GCase activity in-vitro and in-vivo. Ambroxol therefore has the potency to become a disease modifying therapy in PD, which was the reason to design this randomized controlled trial with ambroxol in PD patients. Methods: This trial is a single-center, double-blind, randomized, placebo-controlled study, including 80 PD patients with a GBA mutation, receiving either ambroxol 1800 mg/day or placebo for 48 weeks. The primary outcome measure is the Unified Parkinson's Disease Rating Scale motor subscore (part III) of the Movement Disorder Society (MDS-UPDRSIII) in the practically defined off-state at 60 weeks (after a 12-week washout period). Secondary outcomes include a 3,4-dihydroxy-6-18F-fluoro-I-phenylalanine ([18F]FDOPA) PET-scan of the brain, Magnetic Resonance Imaging (with resting state f-MRI and Diffusion Tensor Imaging), GCase activity, both intra- and extracellularly, sphingolipid profiles in plasma, Montreal Cognitive Assessment (MoCA), quality of life (QoL) measured by the Parkinson's Disease Questionnaire (PDQ-39) and the Non-Motor Symptom Scale (NMSS) questionnaire. Discussion: Ambroxol up to 1200 mg/day has shown effects on human cerebrospinal fluid endpoints, which supports at least passage of the blood-brain-barrier. The dose titration in this trial up to 1800 mg/day will reveal if this dose level is safe and also effective in modifying the course of the disease. Trial registration: NCT05830396. Registration date: March 20, 2023. [ABSTRACT FROM AUTHOR]

Physical activity (PA) is recommended as part of the management of narcolepsy type 1 (NT1). This study aimed at 1) characterizing PA in children and adolescents treated for NT1 using objective and subjective measurements, 2) evaluating how PA is associated with NT1 symptoms and comorbidities, and 3) evaluating the effects of an Adapted Physical Activity (APA) program on PA and clinical characteristics. Patients with NT1 from the National Reference Center of Narcolepsy (Lyon, France) were consecutively included in an APA intervention protocol. Narcolepsy symptoms and comorbidities were collected using standardized questionnaires and sustained attention was evaluated using the Bron-Lyon Attention Stability Test before and after the four-week APA intervention. PA was measured objectively using actigraphy throughout the study. Twenty-seven NT1 patients were included (median age 14.7 years [8.3–18.4], cataplexy 88.9%, obesity 37.0%). At baseline, 52.4% of the patients had satisfactory PA levels according to international recommendations. Patients with leisure-time PA (LTPA) showed higher quality of life than patients without. 45% of the patients increased PA during the intervention compared to baseline. These responsive patients had more depressive feelings and tended to have lower objective PA than non-responsive patients at baseline. No significant correlation was found between PA levels before and during the intervention and other clinical data. Most children with NT1 showed satisfying PA levels despite their daytime sleepiness. LTPA engagement was associated with higher quality of life. An APA intervention could be effective in children with narcolepsy, especially for those with depressive feelings. • More than half of the children with narcolepsy were physically active. • Those who engaged in leisure time physical activities showed higher quality of life. • Those with depression are particularly responsive to a physical activity program. [ABSTRACT FROM AUTHOR]

Abstract Introduction This post hoc analysis of the phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program assessed the effect of filgotinib on body mass index (BMI) in patients with RA and the impact of BMI on the efficacy and safety of filgotinib. Methods FINCH 1–3 were randomized, double-blind, active- or placebo-controlled phase 3 trials of filgotinib 100 and 200 mg in patients with RA (N = 3452). BMI assessments included the mean change from baseline in BMI and the proportion of patients whose BMI increased by incremental thresholds. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 response and low disease activity/remission according to Disease Activity Score 28 using C-reactive protein. The exposure-adjusted incident rate (EAIR) of adverse events (AEs) was assessed by baseline BMI, using integrated data from the FINCH 1–4 and the phase 2 DARWIN 1–3 studies (total filgotinib exposure = 8085 patient-years). Results Mean change from baseline in BMI over time was similar across treatment arms. In most patients, BMI increased by ≤ 1 or 2 kg/m2 at both weeks 12 and 24, regardless of treatment group or baseline BMI; few patients had increases of ≥ 4 kg/m2. For most efficacy measures, filgotinib 200 mg was more efficacious than filgotinib 100 mg or active comparators or placebo across BMI subgroups. For the higher filgotinib dose, the EAIR of serious treatment-emergent AEs, venous thrombotic and embolic events, and major adverse cardiovascular events increased with increasing BMI. Conclusions Filgotinib did not lead to substantial changes in BMI, and BMI did not appear to affect the efficacy of filgotinib. Trial Registration ClinicalTrials.gov identifiers: NCT02889796, NCT02873936, NCT02886728, NCT03025308, NCT01888874, NCT01894516, NCT02065700.

Introduction: This post hoc analysis of the phase 3 rheumatoid arthritis (RA) filgotinib clinical trial program assessed the effect of filgotinib on body mass index (BMI) in patients with RA and the impact of BMI on the efficacy and safety of filgotinib. Methods: FINCH 1–3 were randomized, double-blind, active- or placebo-controlled phase 3 trials of filgotinib 100 and 200 mg in patients with RA (N = 3452). BMI assessments included the mean change from baseline in BMI and the proportion of patients whose BMI increased by incremental thresholds. Efficacy measures included American College of Rheumatology (ACR) 20/50/70 response and low disease activity/remission according to Disease Activity Score 28 using C-reactive protein. The exposure-adjusted incident rate (EAIR) of adverse events (AEs) was assessed by baseline BMI, using integrated data from the FINCH 1–4 and the phase 2 DARWIN 1–3 studies (total filgotinib exposure = 8085 patient-years). Results: Mean change from baseline in BMI over time was similar across treatment arms. In most patients, BMI increased by ≤ 1 or 2 kg/m2 at both weeks 12 and 24, regardless of treatment group or baseline BMI; few patients had increases of ≥ 4 kg/m2. For most efficacy measures, filgotinib 200 mg was more efficacious than filgotinib 100 mg or active comparators or placebo across BMI subgroups. For the higher filgotinib dose, the EAIR of serious treatment-emergent AEs, venous thrombotic and embolic events, and major adverse cardiovascular events increased with increasing BMI. Conclusions: Filgotinib did not lead to substantial changes in BMI, and BMI did not appear to affect the efficacy of filgotinib. Trial Registration: ClinicalTrials.gov identifiers: NCT02889796, NCT02873936, NCT02886728, NCT03025308, NCT01888874, NCT01894516, NCT02065700. Plain Language Summary: Some rheumatoid arthritis treatments cause patients to gain weight or are less effective in patients with obesity than in patients without obesity. Also, obesity can make rheumatoid arthritis worse. Filgotinib is a rheumatoid arthritis treatment that was evaluated in seven randomized clinical studies (FINCH 1–4 and DARWIN 1–3). We investigated whether filgotinib causes changes in weight and whether body mass index (BMI) affects the efficacy or safety of filgotinib. We analyzed how the BMI of patients who participated in FINCH 1, 2, or 3 changed over time. Most patients had a small increase in BMI (around 1–2 kg/m2) after 24 weeks of filgotinib treatment. This change in BMI was not affected by patients' BMI at baseline. Baseline BMI did not impact the efficacy of filgotinib, which was assessed using standard measures of disease activity. Filgotinib was more effective than other rheumatoid arthritis treatments and placebo in all patients, regardless of BMI subgroup. Using safety data from all seven clinical studies (FINCH 1–4 and DARWIN 1–3), we found that some adverse events occurred more often in patients with obesity (a BMI of ≥ 30 kg/m2) than in those without obesity. The increased adverse events included venous thrombotic and embolic events and major adverse cardiovascular events, for which obesity is a known risk factor. These results show that filgotinib did not substantially change BMI (which increased by around 1–2 kg/m2 in most patients), and that baseline BMI did not affect the efficacy of filgotinib. [ABSTRACT FROM AUTHOR]

Introduction: Objectives were to assess how different techniques (including a novel ringless sectional matrix approach) affect students' restorative outcomes, and their preferences for and preparedness to clinically implement new techniques with the aim of introducing appropriate techniques to the undergraduate curriculum. Materials and Methods: Students performed two class II composite restorations in plastic teeth using two sectional matrix techniques (separating ring vs. without [ringless]), and two composite restorative techniques (incremental vs. injection‐moulded bulk‐fill). Restorations were assessed on multiple parameters which were combined to rate them as "good" or not. Online surveys assessed students' preferences for and preparedness to clinically implement new techniques. Results: Contact area concavity (OR = 106, p <.001) and cervical marginal overhang (OR = 7.4, p <.001) were much more likely with the separating ring compared to the ringless sectional matrix technique. "Good" restorations were 29.5 times more likely when using ringless compared to separating ring techniques and 3.3 times more likely when using the injection‐moulding bulk‐fill compared to layered composite technique. A majority of students preferred the ringless to separating ring sectional matrix technique and the injection‐moulding bulk‐fill to layered composite technique. Large majorities felt prepared to implement the new techniques clinically with no or minimal guidance. Conclusions: A classic sectional matrix technique with separating ring resulted in a much greater occurrence of contact area concavity and cervical marginal overhang than a novel ringless approach. When allied with student preferences and clinical preparedness, inclusion of the novel ringless approach in the undergraduate curriculum can be supported alongside bulk‐fill injection‐moulding techniques. [ABSTRACT FROM AUTHOR]

The current rehabilitation therapy protocols for management of individuals with spinal cord injury or disease aim to maximize restoration of remaining function and minimize secondary health conditions. In addition, several novel rehabilitation therapies for management of spinal cord injury or disease have been reshaping the field over the past two decades. This scoping reviewanalyzes the trends and features of the recently completed and ongoing clinical studies on the rehabilitation of individuals with spinal cord injury or disease that were registered in the ClinicalTrials.gov Website. Furthermore, this in-depth review synthesizes and appraises what was learned and what will potentially be discovered in the near future from the clinical studies on the rehabilitation after spinal cord injury or disease. [ABSTRACT FROM AUTHOR]

Dyslipidemia is an important risk factor for coronary artery disease and stroke, and it has emerged as a major public health issue worldwide. Internet-based health management and intervention may offer a new approach to health management. This study was conducted to provide health guidance and education to people with dyslipidemia using an Internet health management platform and to assess the effectiveness of Internet health management and intervention in improving health-related behaviors and controlling blood lipids. Starting in 2013 (Baseline, N = 56,542), a Western longitudinal study in China was performed, and all interventional objects were provided with Internet health management. Health checkups were conducted annually, and questionnaires were administered every two years to analyze changes in health behaviors two years (2015) and four years (2017) following the intervention. In addition, factors affecting behavioral changes and lipid control were analyzed in the dyslipidemic population to understand the effectiveness and influencing factors of Internet health management on lipid control. By guiding interventional objects through the Internet health management platform, the awareness rate of dyslipidemia increased from 19.1% in 2013 to 34.4% in 2017; and the control rate of dyslipidemia increased from 9.1% at baseline to 18.5%. Certain health-related behaviors that are beneficial to health (tobacco use, physical activity, and partial dietary) were gradually improved over the intervention time. For patients with dyslipidemia, triglyceride decreased from 2.90 mmol/L (2013) to 2.77 mmol/L (2017) as the years went by. Analysis of factors affecting lipid control showed that non-compliance with health instructions affected lipid control; in addition to these, being female (0.722, 95% CI: 0.546,0.954) was found to be a protective factor for effective lipid control. The basic Internet-based health management platform in this study appears to be moderately successful and is a valuable and feasible application. Tobacco, dietary, and physical activity interventions provided significant protection against dyslipidemia in patients. [Display omitted] • Internet-based health management and intervention can improve the awareness rate and control rate of dyslipidemia. • By guiding individuals through the Internet health management platform, their health-related behaviors beneficial to health were gradually improved over the intervention time. • Serum cholesterol and triglyceride of patients with dyslipidemia decreased year by year over the intervention time. [ABSTRACT FROM AUTHOR]

Introduction: Since June 15, 2009, clinical trial registration in the Clinical Trial Registry-India (CTRI) has been made mandatory by the Drugs Controller General of India to improve transparency, accountability, conform to accepted ethical standards and reporting of all relevant results of registered trials. In this study, we planned to evaluate the compliance of Indian and global sponsors with clinical trials conducted in India in terms of reporting of clinical trial results at the CTRI. Methods: We included trials registered in the CTRI between January 2018 and January 2020. The CTRI and ClinicalTrials.gov registry was thoroughly searched for all completed interventional studies. A year-wise comparative analysis was performed to evaluate the number of clinical trials reporting results in both the registry. Results: The reporting of completed interventional clinical trial results was 25/112 (22.32%) in year 2018, y, 8/105 (7.6%) in year 2019 and 17/140 (12.14%) in year 2020. There was significantly less reporting of results of Pharmaceutical company sponsored Interventional Studies-Indian at CTRI when compared with ClinicalTrials.gov registry for the year 2019 (odds ratio [OR]-0.17 (95% confidence interval [CI]: 0.08--0.36) and P < 0.0001) and year 2020 (OR-0.45 [95% CI: 0.24--0.82] and P < 0.01). The difference in results reported at CTRI was significantly low for Pharmaceutical company sponsored Interventional Studies-Global only for year 2019 (OR-0.09 [95% CI: 0.005--1.45] and P = 0.04) compared with ClinicalTrials.gov. Conclusion: There is a need to develop the culture of reporting clinical trial results in CTRI to strengthen the transparency in the research for overall benefit of public, health care professionals, and research community. [ABSTRACT FROM AUTHOR]

This article is devoted to an ethical review of planned real-world studies. The legal basis of such examinations has also been considered. Most real-world studies are non-interventional, so the ethical review of such studies is similar to that of observational studies.

Respiratory tract infections are one of the major causes of morbidity and mortality in older adults. This quasi-experimental study aimed to evaluate the effect of an educational intervention on respiratory infections prevention (RIP) in rural older adults. The study sample composed of 80 older adults from a rural area, randomly assigned into two groups. The intervention group (n = 40) received ten 1-hour twice-weekly sessions and the control group (n = 40) received no intervention. Pre- and post-intervention assessments were done using measures of knowledge, attitudes, and practices regarding RIP. Chi-square test, Fisher's exact test, independent samples t -test, and paired t -test were used for data analysis. The study findings showed that the study intervention resulted in statistically significant improvements in the intervention group's knowledge, attitudes, and practices regarding RIP compared with the control group (p <.01). The educational intervention was effective and could be used to help rural older adults prevent respiratory infections. [ABSTRACT FROM AUTHOR]

Introduction Since the beginning of the COVID-19 pandemic, sanitary context and e-learning has greatly modified students’ lifestyles. An increase of sedentary behaviors, a reduction in physical activity (PA) and a stronger tendency to move towards unhealthy diet have been demonstrated. Most of the research is largely descriptive and to date, no interventional studies have been conducted to prevent the deterioration of students’ health. Objectives The objective of the present research aims to evaluate the effects of an intervention program on the lifestyle and psychological state of student. Its primary objective is to promote PA among students, to improve both physical condition and motivation to engage in physical activity for one’s health by promoting motivational levers. Its second objective is to reduce and/or prevent the deterioration of the health of university students. Methods Students from University of Nîmes were recruited and randomly assigned to one of the two following conditions: an experimental group and a control group. The experimental group participated to an 8-weeks program of PA (co-constructed by users during design-based innovative workshops) whereas the control group did not. For each group, measures of PA, sedentary time, anthropometric data, sleep, physical condition and psychological variables (anxiety, depression, motivation, body appreciation, perceived control, well-being, …) were carried out before (T1: october 2021) and after (T2: December 2021) these 8-weeks in order to evaluate the benefits from the PA program. Results These assessments were performed in October 2021 (T1) and December 2021 (T2). Conclusions Data are still being collected and will be presented in April 2022. Disclosure No significant relationships.

This scoping review examined the current trends and characteristics of the clinical research initiatives on the management of acute spinal cord injury. This review included all clinical studies on the acute treatment of spinal cord injury that were registered in the ClinicalTrials.gov website from February 2000 to December 2020. The search strategy combined the terms "acute spinal cord injury" and "treatment." There has been a gradual increase in the number of registered clinical studies on acute treatment of spinal cord injury over the past two decades. Of the 116 studies, there were 103 interventional studies, 12 observational studies, and 1 registry. While 115 clinical studies recruited male and female participants, most of the registered clinical studies included only adults with an upper age limit after spinal cord injury. Most of the registered clinical studies were interventional studies led by single institutions in North America (n = 70), Europe (n = 29), and Asia (n = 15). Most of the research initiatives were interventional studies on new therapies for management of individuals with spinal cord injury (n = 91). In conclusion, the results of this scoping review suggest that although there has been an increase in the amount and diversity of the research initiatives on treatment of acute spinal cord injury over the past two decades, their generalizability remains relatively limited. [ABSTRACT FROM AUTHOR]

This study examined whether participants with poor activities of daily living (ADLs) at hospital discharge had increased weight loss after 6 months of follow-up and whether nutrition therapy can prevent this weight loss. This dietary randomized controlled trial (N = 104) examined community-dwelling older adults (66-95 years) discharged from hospital and at risk for malnutrition, receiving either 6 months of nutrition therapy (intervention) or only standard care (control). ADL was assessed using seven questions on self-care based on the Katz et al.'s method. At discharge, 45 (43%), 36 (35%), and 23 (22%) had high, medium, and poor ADL, respectively, with no differences between the control and intervention groups according to chi-square test. Participants in the control group with poor ADL had significantly higher weight loss than participants with high ADL (age- and sex-adjusted analysis of covariance: 3.6 kg; 95% confidence interval [1.0, 6.1] kg, p = .007). No such difference was observed in the intervention group. Participants with poor ADL at hospital discharge develop lower body weight by around 3.5 kg 6 months later when compared with participants with high ADL. Receiving nutrition therapy could help older adults with poor ADL to maintain body weight after hospital discharge.

Background: Adolescents and young adults often experience existential concerns in addition to side effects during a cancer trajectory, which they often carry alone. Thus, cohesion with other adolescents and young adults with cancer is essential but difficult due to the relatively small, widely dispersed nationwide population. In cocreation, a smartphone app has been developed and includes an information bank, a symptom tracker, and a social community platform, aiming to improve the quality of life (QoL) in this patient group., Objective: This nationwide, multicenter study aimed to investigate the QoL in adolescents and young adults undergoing a cancer trajectory as they used the app for 6 weeks., Methods: Via youth support initiatives, participants were recruited from hospitals in all regions of Denmark. Inclusion criteria were patients with cancer aged 15-29 years who either initiated any cancer treatment or started follow-up after cancer treatment within 30 days. Participants used the adolescents and young adults cancer app for 6 weeks. Before and after the 6 weeks of app use, they completed the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30). The participants were divided into a treatment and a follow-up group for analysis. A high score for a functional scale or the global health or overall QoL represents a high or healthy level of functioning or high QoL, respectively; however, a high score for a symptom scale or item represents a high level of symptomatology., Results: Overall, 81 participants were recruited. However, 4 participants did not answer the questionnaire and 6 participants did not use the app. In the treatment group (n=36), significant improvement was found in 2 domains: "Role functioning" (baseline median 33.33, IQR 16.67-83.33 vs 6 weeks median 66.67, IQR 33.33-83.33; P=.04) and "Pain" (baseline median 33.33, IQR 16.67-50.00 vs 6 weeks median 16.67, IQR 0.00-33.33; P=.04). The "Global health/Overall QoL" scale remained stable (baseline median 58.33, IQR 45.83-77.08 vs 6 weeks median 62.50, IQR 41.67-75.00; P=.25). In the follow-up group (n=35), significant improvement was found in 3 domains: "Physical functioning" (baseline median 79.23, IQR 73.33-93.33 vs 6 weeks median 82.86, IQR 73.33-100.00; P=.03), "Cognitive functioning" (baseline median 62.38, IQR 50.00-83.33 vs 6 weeks median 69.52, IQR 50.00-100.00; P=.02), and "Social functioning" (baseline median 76.19, IQR 50.00-100.00 vs 6 weeks median 85.71, IQR 83.33-100.00; P=.05), as well as in the "Global health/Overall QoL" scale (baseline median 57.14, IQR 83.33-100.00 vs 6 weeks median 75.0, IQR 62.91-85.73; P<.001)., Conclusions: In this study, we found an improvement in specific QoL scales for both participants in treatment and follow-up when using the app for 6 weeks. The global health or overall QoL score improved significantly in the follow-up group. In the treatment group, it remained stable., International Registered Report Identifier (irrid): RR2-10.2196/10098., (©Line Bentsen, Signe Hanghøj, Maiken Hjerming, Mette Buur Bergmann, Marianne Thycosen, Anette Borup, Camilla Larsen, Helle Pappot. Originally published in JMIR Cancer (https://cancer.jmir.org), 04.12.2023.)

Background: Despite research and efforts to mitigate bacterial resistance, antibiotic overprescribing continues to occur, often due to real or perceived expectations of patients.  Objective: The purpose of this study was to determine: (1) if there's an association between the provider's patient education efforts and the patient's satisfaction, and (2) the research participant's subsequent behavior concerning antibiotic prescriptions, by utilizing the Stewardship Through Educating Patients (S.T.E.P.) process for positive prescriptive change. The S.T.E.P. program features straightforward, simple education via face-to-face counseling at patient encounters, along with presenting applicable printed educational pamphlets from the Centers for Disease Control and Prevention (CDC). These two interventions were utilized in this study with research participants from the healthcare provider, with education focused on appropriate antibiotic use in the treatment of adults diagnosed with common illnesses such as an upper respiratory infection (the common cold), acute sinusitis, and acute bronchitis, which oftentimes are viral in origin., Method: This Quality Improvement (QI) interventional study utilized the researcher's direct face-to-face patient education and CDC printed materials as a measure of antibiotic prescribing as a primary outcome, with patient satisfaction as a secondary outcome via convenience sampling of 40 hospital employees who utilized a free hospital-based employee healthcare clinic., Results: Patient-teaching by this study's researcher, along with supplemental printed patient education material from the CDC that were given to research participants during an initial medical encounter, were effective interventions used in reducing antibiotic prescribing, as evidenced by a positive patient satisfaction in 95% of research participants., Conclusions: Antibiotic use in the treatment of adults diagnosed with common illnesses such as an upper respiratory infection (the common cold), acute sinusitis, and acute bronchitis, may be safely reduced by using a combination of patient-education and clinician intervention., Competing Interests: The authors have declared that no competing interests exist., (Copyright © 2023, Havlicek et al.)

Scope: This study evaluates how manufacturing conditions of probiotic biomass production, using two different cryoprotectants, Cryo-A and Cryo-B, can affect Streptococcus thermophilus BT01 in vivo gastrointestinal tract survival and its ability to modulate the level of urease activity in fecal samples of healthy subjects., Methods and Results: A randomized controlled cross-over study is carried out on 20 adult healthy subjects to evaluate total and viable loads, persistence of S. thermophilus BT01, and urease activity in fecal samples. Strain-specific quantification by using developed culture-based method and molecular qPCR tool allows to quantify viable S. thermophilus BT01 strain in 90% of the subjects. The quantification of both total DNA and recovered viable S. thermophilus BT01 in fecal samples does not reveal significant differences between Cryo-A or Cryo-B treated biomass. However, the administration of S. thermophilus BT01 produced with Cryo-A results in a decreased urease activity in fecal samples compared to Cryo-B protected cells., Conclusion: This study i) highlights how the manufacturing conditions can play a role in influencing the probiotic functionality in vivo and ii) represents the first evidence that links S. thermophilus to a specific probiotic mechanism, the reduction of urease activity in fecal samples., (© 2023 The Authors. Molecular Nutrition & Food Research published by Wiley-VCH GmbH.)

Background: Digital technologies are increasingly used in health research to collect real-world data from wider populations. A new wave of digital health studies relies primarily on digital technologies to conduct research entirely remotely. Remote digital health studies hold promise to significant cost and time advantages over traditional, in-person studies. However, such studies have been reported to typically suffer from participant attrition, the sources for which are still largely understudied.Objective: To contribute to future remote digital health study planning, we present a conceptual framework and hypotheses for study enrollment and completion. The framework introduces 3 participation criteria that impact remote digital health study outcomes: (1) participant motivation profile and incentives or nudges, (2) participant task complexity, and (3) scientific requirements. The goal of this study is to inform the planning and implementation of remote digital health studies from a person-centered perspective.Methods: We conducted a scoping review to collect information on participation in remote digital health studies, focusing on methodological aspects that impact participant enrollment and retention. Comprehensive searches were conducted on the PubMed, CINAHL, and Web of Science databases, and additional sources were included in our study from citation searching. We included digital health studies that were fully conducted remotely, included information on at least one of the framework criteria during recruitment, onboarding or retention phases of the studies, and included study enrollment or completion outcomes. Qualitative analyses were performed to synthesize the findings from the included studies.Results: We report qualitative findings from 37 included studies that reveal high values of achieved median participant enrollment based on target sample size calculations, 128% (IQR 100%-234%), and median study completion, 48% (IQR 35%-76%). Increased median study completion is observed for studies that provided incentives or nudges to extrinsically motivated participants (62%, IQR 43%-78%). Reducing task complexity for participants in the absence of incentives or nudges did not improve median study enrollment (103%, IQR 102%-370%) or completion (43%, IQR 22%-60%) in observational studies, in comparison to interventional studies that provided more incentives or nudges (median study completion rate of 55%, IQR 38%-79%). Furthermore, there were inconsistencies in measures of completion across the assessed remote digital health studies, where only around half of the studies with completion measures (14/27, 52%) were based on participant retention throughout the study period.Conclusions: Few studies reported on participatory factors and study outcomes in a consistent manner, which may have limited the evidence base for our study. Our assessment may also have suffered from publication bias or unrepresentative study samples due to an observed preference for participants with digital literacy skills in digital health studies. Nevertheless, we find that future remote digital health study planning can benefit from targeting specific participant profiles, providing incentives and nudges, and reducing study complexity to improve study outcomes. [ABSTRACT FROM AUTHOR]