Usual Practice Research Articles

The effectiveness of neuromuscular training warm-up program for injury prevention in adolescent male basketball players

ABSTRACT This study evaluated the effects of a neuromuscular training (NMT) warm-up program on injury incidence, neuromuscular function, and program adherence, maintenance and acceptance in adolescent basketball players. A total of 275 players from 20 Slovenian teams (15 ± 1.7 years of age), were randomized into an intervention group (IG, n=129) and a control group (CG, n=146). Over three months, the IG incorporated NMT into their warm-ups, while the CG followed their usual practice. Measurements of body anthropometry, muscle contractile properties, and balance were taken before and after the intervention. Also, the injury incidence, training adherence and maintenance were reported. Both groups showed improved balance, with no significant difference between them. However, IG demonstrated reduced delay times in specific muscles, indicating improved neuromuscular function. Injury prevalence proportion (%) during the whole study period was higher in the control group compared to intervention (IG: 10.9% vs. CG: 23.3%), and incidence rate. Moreover, the incidence rate ratio for sustaining an injury was 2.6 on average (ranging from 0.88 to 7.07 for tendon and muscle injuries, respectively), indicating significantly lower injury risk in IG than CG. These findings highlight the effectiveness of NMT warm-ups in reducing injury risk and enhancing neuromuscular function, emphasizing the value of structured injury prevention strategies in youth sports..

Connected Communities | Learning lessons from person-centred community-based support services’ implementation: a mixed-methods study protocol.

Background Person-centred community-based support services (PCCBSS) are an array of non-clinical services provided by organisations such as NHS Trusts, voluntary sector organisations, or local authorities. All PCCBSS involve an individual (variously known as a 'social prescriber’, ‘link worker’, ‘signposter’, ‘navigator’, ‘connector’ or ‘neighbourhood coach’) who talks with a service user before directing them to a range of relevant community sources of social, emotional, and practical support. Despite much recent investment in social prescribing, and its increased prominence within the policy context across England, little is understood about how PCCBSS are implemented. Research is required across different contexts to describe PCCBSS implementation; in particular, how social care providers successfully interact to support the implementation of PCCBSS, and how services responded to circumstances imposed by the COVID-19 pandemic. Purpose The aim of this post-implementation mixed-methods study is to explore how PCCBSS are implemented and become part of usual working practice. Using three services in North West England as case studies, we will examine factors influencing PCCBSS implementation and establish where there is learning for the wider adult social care system. Focus The study comprises two work packages (WPs): WP1: collecting data by reviewing service documents from three PCCBSS case studies; WP2: interviewing staff and service users (≤20 participants per PCCBSS); Key implementation data will be systematically abstracted (from WPs1&2) into a coding frame; combining contextual determinants from the Consolidated Framework for Implementation Research (CFIR) with process-related domains from Normalization Process Theory (NPT). Key outputs The findings from WP1 and WP2 will be presented in the form of an illustrated ‘pen portrait’, developed collaboratively with Applied Research Collaboration North West Coast (ARC NWC) public advisers, to illustrate how implementation evolved for each of the PCCBSS across key time-points in the process (initiation; operation; maintenance). The findings will also inform an online implementation toolkit providing recommendations for setting up future PCCBSS.

Effectiveness and Durability of a Workplace Sedentary Behavior Intervention Based on the Total Worker Health® Approach

We used the Total Worker Health® approach to develop a multi-component workplace sedentary behavior intervention and tested intervention effectiveness in a cluster randomized trial. Participants (n = 198; 75% female) were recruited from three call-centers (two intervention and one usual practice control). All worksites received pedal stand active workstations. The usual practice site received no additional support, while the intervention group completed a six-month program of activities including computer-based training, behavioral self-monitoring, health and safety discussions, and pedaling competitions. Data collection included a survey, a physical health assessment, and accelerometer measures of sedentary behavior, physical activity, and sitting/standing time. Primary analyses were generalized estimating equations comparing changes between intervention and usual practice conditions over time, along with analyses of changes in both groups combined over time. Six-month results revealed less prolonged sitting and reductions in musculoskeletal pain in both groups (all p < 0.05), while the intervention group showed additional improvements in moderate physical activity (p < 0.001) and use of pedal stands (p < 0.01). At 12-months, the additional physical activity and pedal stand use in the intervention group regressed to baseline levels, while reductions in prolonged sitting in both groups were durable (p < 0.01). This study adds to previous research showing the effectiveness of the Total Worker Health® approach for workplace health and safety. Results also show that, while providing employees with health and safety resources is beneficial, providing ongoing support for the adoption and use of resources is more effective.

Agronomic and Economic Evaluation of Common Bean-Tef in Double Cropping System

Double-cropping of cereals with legumes is a usual practice by small-holder farmers in southern parts of Ethiopia but crop compatibility and sequencing are the major problems for their soil fertility as well as profitability. Thus, it was important to conduct research on double cropping systems that can make the farmers more profitable on small land to reduce crop failure with current climate change. Thus, an experiment was done to evaluate the effects of these crops as double cropping on the productivity of tef and to evaluate the agronomic and economic value of common bean-tef in double cropping system for an improved production system at Shashemene district during the cropping season of 2022 and 2023 using RCBD design. The experiment consisting of twelve treatments including one common bean and three N rate with three tef varieties was sowed as the preceding and succeeding crop respectively and three sole tef varieties used as a control. The preceding crop the Hawassa dume common bean variety had 8 ton/ha dry biomass and 35 Qt/ha grain yield. The variance analysis showed that all the growth and yield parameters of tef except harvest index were significant such as Plant Height, Panicle Length, Straw Yield, Biomass yield, Grain Yield (p<0.05).

Mental health of parents with infants in NICU receiving cooling therapy for hypoxic-ischaemic encephalopathy

ABSTRACT Background Parents cuddling their babies during intensive care to promote parent-infant bonding is usual practice in the neonatal intensive care unit (NICU). However, babies undergoing cooling therapy and intensive care are not routinely offered parent-infant cuddles due to concerns of impacting the cooling process or intensive care. We developed the CoolCuddle intervention to enable parents to cuddle babies safely during cooling therapy. We investigated whether CoolCuddle impacted parent-infant bonding and parent’s mental health. Methods We conducted parental interviews and compared mental health and bonding measures in two cohorts of parents; one with access to CoolCuddle and the other where CoolCuddle was not available. Results Ten tertiary NICUs in England and Wales from 2019 to 2023 were involved and 107 families. There were high levels of post-delivery depression amongst all parents. However, at discharge mothers in the CoolCuddle group had significantly less depression, lower EPDS scores, and higher MIBS scores (consistent with better mother-infant bonding) than those where CoolCuddle was not available. All measures appeared similar when re-measured at 8 weeks. Parents reported they were not ready to access psychological support or information whilst on NICU and stressed the need of mental health support following discharge, which was not offered or available. Conclusion The CoolCuddle intervention was associated with a lower prevalence of depression and enhanced bonding scores for mothers at discharge compared to those who did not cuddle their babies. Parents highlighted increased levels of postnatal depression following the sudden and traumatic admission of their infant to NICU after birth asphyxia.

BRIVA-ONE study: 12-month outcomes of brivaracetam monotherapy in clinical practice.

This study investigated the effectiveness and tolerability of brivaracetam (BRV) monotherapy in a large series of patients with epilepsy. This was a multicenter, retrospective, observational, non-interventional study in 24 hospitals across Spain. Patients aged ≥18 years who started on BRV monotherapy, either as first-line or following conversion, at least 1 year before database closure were included. Patients were evaluated at baseline and at 3, 6 and 12 months after initiation of BRV monotherapy, in accordance with usual clinical practice at these centers. Data were collected retrospectively from patients' individual charts by participating physicians. The primary effectiveness and safety endpoints were the percentage of seizure-free patients 1 year after initiation of BRV monotherapy and the proportion of patients reporting adverse events (AEs) over the complete follow-up period. Retention rates and subpopulation analysis (levetiracetam switchers, elderly and different etiologies) were also investigated. A total of 276 patients were included (48 with BRV as first-line monotherapy and 228 who converted to BRV monotherapy). The overall retention rate in monotherapy at 12 months was 89.9% (87.5% for first-line monotherapy group; 90.4% for conversion-to-monotherapy group). Seizure-freedom rates at 12 months were 77.8% (75% for first-line monotherapy group; 78.4% for conversion-to-monotherapy group). AEs occurred in 39.5% of patients at 12 months (35.4% for first-line monotherapy group; 40.4% for conversion-to-monotherapy group). Most AEs were mild-to-moderate. The most frequent AEs were irritability (12.3%) and dizziness (10.1%). The most frequent AEs leading to BRV withdrawal were dizziness (1.8%) and memory problems (1.4%). Similar outcomes in terms of effectiveness and tolerability of BRV monotherapy were observed in patients switching from levetiracetam, those with different epilepsy etiologies, and elderly patients. BRV was effective and well tolerated both as first-line monotherapy and following conversion to monotherapy in a real-world setting of patients with epilepsy. The goal of the medical treatment of epilepsy is to ensure best possible patient quality of life, by maximizing seizure control and minimizing medication toxicity. Brivaracetam (BRV) is a new-generation epilepsy treatment that is well tolerated by patients. In our study, monotherapy with BRV reduced seizures in patients who had not received other treatments and in patients who switched from a previous treatment to BRV monotherapy. BRV was well tolerated and also effective in sensitive patients (i.e., the elderly and those who had epilepsy caused by a brain tumor or a brain injury).

Falsas creencias en torno al dolor. Consejos educativos breves en la consulta de atención primaria

In chronic non-oncological pain, there is a gap between the recommendations and the usual clinical practice. To improve this situation, it is essential to address unhelpful beliefs about pain in patients and health professionals. We address cultural beliefs such as thinking that pain means damage to the tissue where it is felt, that pain originates in the area where it is perceived, that it is important to rest for the tissues to heal, or that drugs and surgery are the best treatments for pain.First, professionals need to reflect on their own beliefs and question their own clinical practice: what do I believe about pain? Are these beliefs in line with current evidence? Do I follow the recommendations of clinical practice guidelines? In this way, by aligning their beliefs with the evidence, professionals will be able to begin to give appropriate educational advice to patients.

Close clinical monitoring of patients after TAVI implantation using artificial intelligence with a virtual voice assistant

Abstract Introduction The number of procedures and patients candidates for transcatheter aortic valve implantation (TAVI) has increased considerably due to population ageing and the rise in scientific evidence supporting this technique in patients with increasingly lower surgical risk. Early discharge would allow for a more efficient use of available resources, in addition to improving patients’ functionality and quality of life. Objective The use of a virtual voice assistant based on artificial intelligence, could be an effective and safe alternative to closely monitor patients after TAVI implantation in order to facilitate early identification of complications and a more efficient use of the resources available in Cardiology services. Material and methods Observational, prospective, single-center and consecutive study of the implementation of a technology based on artificial intelligence and natural language processing to monitor all patients undergoing transfemoral TAVI implantation, according to usual clinical practice, in the hemodynamics unit of our hospital in the year 2023. The virtual voice assistant, "Lola", carries out a telephonic follow-up during week 1, week 2, month 1, month 3 and 12. In these calls, it asks a series of questions mainly related to vascular access and with the patient's cardiovascular situation. After finishing the call, all the information collected is uploaded to a web platform where we monitor the collected data and thus take the appropriate measures. Results After 12 months, 274 patients have been included to whom 1,039 calls have been made with a total of 385 hours of autonomous conversation. In 44% of the calls, no alerts were detected and, therefore, did not required further review. From the remaining calls, a total of 926 alerts were collected, the predominant ones being: dizziness (24.9%), contact with the emergency services (11.3%) and alteration of general status (10.4%). The number of alerts decreases as the follow-up progresses, reflecting the need for closer monitoring in the initial stages after implantation. These alerts generated at least one intervention in 57% of the calls, the predominant ones being: medical contact (43.0%), nursing contact (26.3%) and medication adjustment (4.0%). These calls resulted in a total of 15 in-person examinations (5.4% of patients), detecting in 2 of them a 3rd degree atrioventricular block, in 3 a femoral pseudoaneurysm and in 1 a critical stenosis of the common femoral artery. According to a patient survey, 88.9% of patients were satisfied or very satisfied (Customer Satisfaction score 4.68/5). Conclusions The application of artificial intelligence permits strict control of the patient after TAVI implantation, thus facilitating early detection of complications. Patient satisfaction regarding this follow-up system was very high.

Time to detection of serious adverse events by continuous vital sign monitoring versus clinical practice.

Continuous vital sign monitoring detects far more severe vital sign deviations (SVDs) than intermittent clinical rounds, and deviations are to some extent related to subsequent serious adverse events (SAEs). Early detection of SAEs is pivotal to allow for effective interventions but the time relationship between detection of SAEs by continuous vital sign monitoring versus clinical practice is not well-described at the general ward. To quantify the time difference between detection of SAEs by continuous vital sign monitoring and clinical suspicion of deterioration (CSD) in major abdominal surgery patients. Five hundred and five patients had their vital signs continuously monitored in combination with usual clinical practice consisting of National Early Warning Score assessments at least every 8'th hour, assessments during rounds, and other kinds of staff-patient interactions. The primary outcome was the time difference between the first chart note of CSD versus the first SVD, detected by continuous vital sign monitoring, in patients with a subsequent confirmed SAE during or up to 48 h after end of continuous vital sign monitoring. Out of the 505 continuously monitored patients, 142 patients had a combination of both postoperative SAE, CSD and SVD, and thus were included in the primary analysis. The median time from the first SVD to SAE was 42.8 h (interquartile range 19.8-72.1 h) compared to 13 minutes (interquartile range - 4.8 to 3.5 h) for CSD with a median difference of 48.1 h (95% confidence interval 43.0-54.8 h), p-value < .001. Continuous vital sign monitoring detects signs of oncoming SAEs in the form of SVD hours before CSD, potentially allowing for earlier and more effective treatments to reduce the extent of SAEs.

Quality of life after screening for atrial fibrillation: a substudy from a randomised screening trial

Abstract Background Screening for atrial fibrillation (AF) is rising, yet trials have failed to show efficacy for stroke prevention from screening and subsequent anticoagulation. Quality of life is an important outcome for patients and physicians, however, it is largely unknown how this outcome is affected by screening for AF. The adverse effects of screening should be considered before implementing systematic screening. Purpose To explore changes in quality of life associated with screening for AF and subsequent anticoagulant treatment upon AF detection. Methods We used quality of life data from 6,004 persons with stroke risk factors randomised to usual care (n=4,503) or screening for AF using implantable loop recorder and anticoagulation for AF episodes lasting ≥6 minutes (n=1,501). The validated EQ-5D-5L tool evaluates health-related quality of life in five domains (mobility, selfcare, usual activities, pain/discomfort and anxiety/depression), rendering a final score in EQ-index (worst=-0.76 best=1.00) combined with an EQ-VAS score (worst=0, best=100). EQ-index and EQ-VAS were analysed with linear mixed models from baseline through year three. The domains were also analysed with logistic regression to report the risk of major problems (defined as a rating of 3, 4, or 5 in the range [1-5], where 1 corresponds to no problem and 5 corresponds to an extreme problem within a given domain) overall and separately. Sensitivity analyses with imputation for missing data were performed. Results Data were available for 5,162 (86.0%) participants at baseline and in year three, and 227 (5.0%) in usual care and 65 (4.3%) in the screened group had died before the last assessment. At baseline, 1,202 of 5,162 (23.3%) participants reported major pain/discomfort problems, and 666 of 5,162 (12.9%) reported major mobility problems (Figure 1). Major selfcare problems were the least frequent problem reported by 83 of 5,162 participants (1.6%). The occurrence of major problems was increased after 3 years in all domains and in both randomisation groups, with a 2% higher occurrence of major pain/discomfort in the control group compared to the screened group. At baseline, the average EQ-index was 0.88 (±0.16) and EQ-VAS 78.4 (±16.2). After three years, the EQ-index decreased by -0.05 (-0.05; -0.04), p&amp;lt;0.0001 in the control group vs. -0.04 (-0.05; -0.02) in the screened group and EQ-VAS with -6.06 (-6.54; -5.57) in the control group vs. -5.18 (-6.52; -3.78) in the screened group, resulting in no statistically significant difference between the groups (p=0.063 and p=0.056) (Figure 2). The screened group was equally likely to report at least one major problem in quality of life after three years (odds ratio 0.93 (0.77;1.13)), but was less likely to report major pain/discomfort (odds ratio 0.84 (0.72;0.98)), compared with the control group. Conclusion Systematic and intensive screening for atrial fibrillation did not improve quality of life compared to usual practice.

Cooling and physiology during parent cuddling infants with neonatal encephalopathy in usual care: CoolCuddle-2 study.

CoolCuddle, enabling parents to cuddle their babies with neonatal encephalopathy (NE) during therapeutic hypothermia and intensive care (TH), was developed in research settings. To determine the impact of implementing CoolCuddle in usual care in six diverse neonatal intensive care units on the cooling process and intensive care. This vital sign cohort study embedded within the CoolCuddle implementation study enrolled 36 infants receiving TH for NE. Nurses received training on CoolCuddle and a standard operating procedure using an instruction video. After consenting, parents experienced up to 2 h of CoolCuddle with 30 min of pre- and post-cuddle observation. We used multilevel, clustered linear modelling to assess the physiological stability in temperature, cardio-respiratory and neurophysiology across the CoolCuddle. In 60 CoolCuddles over 93.12 h, respiratory parameters, heart rate or neurological function did not vary between the epochs (p > 0.05). During cuddle, sleep-wake cycling on amplitude-integrated EEG increased (p = 0.008) and there was weak evidence of lower pain scores (p = 0.08). No adverse effects were observed. Implementing CoolCuddle with support in usual practice maintained physiological stability and did not significantly affect the cooling process or intensive care, and may improve infant comfort. Ongoing monitoring of adverse effects when implementing CoolCuddle is recommended.

Advancing Community Care and Access to Follow-Up after Acute Kidney Injury Hospitalization: A Randomized Clinical Trial.

Key Points A risk-guided intervention improved adherence to processes of care for AKI survivors.Further supports are necessary to improve uptake of processes of care for AKI survivors in primary care. Background AKI is associated with development and progression of CKD. Gaps in recommended care for CKD are common after AKI. Methods In this randomized controlled trial conducted in Alberta, Canada, we allocated adults hospitalized with Kidney Disease Improving Global Outcomes (KDIGO) stage 2 or greater AKI to a risk-guided, transition of care intervention versus usual practices at the time of hospital discharge. For people in the intervention group, we used a validated risk index to predict risk of severe CKD after AKI. People at low risk (&lt;1%) received patient education alone. People at medium risk received additional clinical guidance, provided to their primary care physician. People at high risk (&gt;10%) were referred to nephrology. The primary outcome was the proportion of patients who received treatment with an angiotensin-converting enzyme inhibitor (ACE-I) or angiotensin II receptor blocker (ARB), statin, and nephrology specialist follow-up within 90 days of discharge. Results One hundred fifty-five patients were recruited; the mean (SD) age was 60 (15) years, 91 (60%) were male, and 96 (62%) had eGFR &lt;60 ml/min per 1.73 m2 or urine albumin-creatinine ratio &gt;30 mg/g at discharge. The proportion of participants who received ACE-I/ARB, statin treatment, and nephrologist follow-up was 28% in the intervention group versus 3% in the usual care group (absolute risk difference [RD], 25%; 95% confidence interval [CI], 15% to 36%). The use of ACE-I or ARB in participants with urine albumin-creatinine ratio &gt;300 mg/g or diabetes was greater in the high-risk group with the intervention versus usual care (RD, 37%; 95% CI, 6% to 67%), as was statin use among those with CKD (RD, 30%; 95% CI, 5% to 56%) and nephrologist follow-up for those with sustained eGFR &lt;30 ml/min per 1.73 m2 at discharge (RD, 78%; 95% CI, 56% to 100%). Hyperkalemia was more frequent in the intervention group (RD, 10%; 95% CI, 9% to 19%). Conclusions A risk-guided intervention for patients hospitalized with AKI increased recommended processes of care for CKD for high-risk patients after hospital discharge. Clinical Trial registry name and registration number: Improving Post Discharge Care after Acute Kidney Injury (AFTER AKI), NCT02915575.

MARKETING DE NOVO PRODUTO - INOVAÇÃO PARA O PÚBLICO ACADÊMICO, UM ESTUDO DE CASO

The launching of new products on the market is a usual practice for some companies, being actions that guarantee their permanence and the creation of competitive values. The present work aims to present a case study of a company launching a distance education course for teacher education and training with a view to marketing planning. With methodology based on observation, bibliographic research in articles and books, document analysis and context analysis, linked to qualitative research. Thus, the viability of critical data collection for marketing planning is perceived. From the data, it is possible to extract scientific information from the actions taken showing the entire project and development of this innovative product, as well as the tactical and strategic planning for decision making. This work is orientative and serves as an instrument for entrepreneurs and academics in the development of new products and new research, respectively.

Remote monitoring of rheumatoid arthritis (REMORA): study protocol for a stepped wedge cluster randomized trial and process evaluation of an integrated symptom tracking intervention

BackgroundManagement of rheumatoid arthritis (RA) relies on symptoms reported by patients during infrequent outpatient clinic visits. These reports are often incomplete and inaccurate due to poor recall, leading to suboptimal treatment decisions and outcomes. Asking people to track symptoms in-between visits and integrating the data into clinical pathways may improve this. However, knowledge on how to implement this into practice and its impact on services and outcomes remains scarce in RA. Therefore, we evaluate the comparative effectiveness and cost-effectiveness of integrated symptom tracking in people with RA over and above usual care, while generating insights on factors for successful implementation.MethodsIn this superiority stepped wedge cluster-randomized controlled trial with continuous recruitment short exposure design, 16 rheumatology outpatient departments (clusters) recruit a total of 732 people with active RA. They initially offer clinic visits according to standard of care before switching in pairs to visits with integrated symptom tracking. Clusters switch in randomized order every 3 weeks. Integrated symptom tracking consists of (1) a mobile app for patients to track their symptoms daily and other RA aspects weekly/monthly, and (2) an interactive dashboard visualizing the app data, which healthcare professionals access from their electronic health record system. Clinic visits happen according to usual practice, with tracked symptom data only reviewed during visits. Our primary outcome is a difference in marginal mean disease activity score at 12 ± 3 months between standard of care and integrated symptom tracking, after accounting for baseline values, cluster, and other covariates. Secondary outcomes include patient-reported disease activity, quality of life and quality-adjusted life-years, medication/resource use, consultation and decision-making experience, self-management, and illness perception. We also conduct interviews and observations as part of a parallel process evaluation to gather information on implementation.DiscussionOur trial will generate high-quality evidence of comparative and cost-effectiveness of integrated symptom tracking compared to standard of care in people with RA, with our process evaluation delivering knowledge on successful implementation. This optimizes the chances of integrated symptom tracking being adopted more widely if we find it is (cost-) effective.Trial registrationRegistered 4-Jun-2024 on https://www.isrctn.com/, ISRCTN51539448.Trial open science framework repositoryhttps://osf.io/sj9ha/.

How do geriatricians practise comprehensive geriatric assessment in the outpatient setting: an analysis of geriatricians' letters and a comparison to the Medicare benefits schedule requirement.

Little is known about what components geriatricians routinely incorporate into outpatient comprehensive geriatric assessments (CGAs). This study explored what components of CGAs are routinely incorporated into geriatricians' letters and assessed their consistency with the Medicare Benefits Schedule (MBS) and a recently published survey of geriatricians. We completed a manual content analysis, supplemented by qualitative thematic analysis, of 34 letters from five geriatricians, collected as part of the GOAL Trial. While more than 80% of letters included each of the key clinical domains described in the Medicare Benefits Schedule and survey of geriatricians, only 62% included advanced care planning and 47% mentioned immunisations. Forty-seven percent of letters included goal setting. Few letters showed evidence of multidisciplinary working. Issues identified by the geriatrician centred around the themes of advance care planning, symptom identification and management, medical comorbidities, strategies to support quality of life and interventions to manage frailty. Patient concerns identified in the letters were cognition and mood, declining function, future planning and symptom management. Analysis of geriatricians' letters provides important and novel insights into usual CGA practice. The letters provide evidence of multidimensional assessments of physical, functional, social and psychological health, and most include use of standardised tools. However, less than 50% include evidence of goal setting or multidisciplinary working. The results allow consideration of how CGAs might be carried out in the outpatient setting, so that interventions focused on improving the quality and efficacy of this intervention can be implemented.

Physical component of SF-36 is associated with measures of disease activity in patients with psoriatic arthritis: a real-life study from a tertiary referral centre.

Psoriatic arthritis (PsA) can lead to chronic disability. The aim of this study was to explore the association between disease activity and quality of life (QoL) in patients with PsA from the usual clinical practice. The study involved 143 consecutive adult patients with PsA (49.6% women and 50.4% males), with mean age of 57.75 ± 10.91 years, and duration of disease 11.6 ± 9 years. Tender (TJC) and swollen joints count (SJC), Disease activity score (DAS) 28, patient's global assessment (PtGA), physician's global assessment (PhGA), enthesitis score, number of fingers with dactylitis, sedimentation rate (ESR) and C-reactive protein (CRP) were evaluated. The functional assessment of chronic illness therapy - fatigue scale (FACIT-F) questionnaire was used in fatigue assessment and physical health domains of Short Form (SF)-36 questionnaire were chosen to assess subjective QoL: physical functioning (PF), role limitations due to physical health (RP), bodily pain (BP) and general health (GH). Significant correlations (p < 0.001) were found between FACIT-F and all SF-36 domains. DAS28, PtGA and PhGA were significantly correlated to two or three SF-36 domains, while ESR and CRP were not significantly correlated to any of SF-36 domains. Regression analysis showed, when controlling for age, that FACIT-F, dactylitis and DAS28 were the most significant predictors of SF-36 physical health domains. Regression and factor analyses confirmed that FACIT-F was most consistently associated with SF-36 physical health domains. In our real-life study most of the analyzed clinical measures of PsA were significantly associated with physical health domains of SF-36 questionnaire. Considering the strength of those associations, we conclude that PsA activity has mild to moderate impact on health-related Qol.

Process evaluation of a breastfeeding support intervention to promote exclusive breastfeeding and reduce social inequity: a mixed-methods study in a cluster-randomised trial

BackgroundBreastfeeding is a powerful public health intervention that produces long-term health benefits. However, in high-income countries such as Denmark, breastfeeding rates are suboptimal and unequally distributed across socio-economic positions. The ‘Breastfeeding – a good start together’ intervention, to promote longer duration of exclusive breastfeeding and reduce social inequity, was implemented in a cluster-randomised trial during 2022–2023 across 21 municipalities in two Danish regions. A process evaluation was conducted to assess the implementation, mechanisms of impact, and possible contextual factors affecting the intervention.MethodsThe study was guided by the Medical Research Council’s guidance for conducting process evaluations and employed a mixed-methods approach in a convergence design. Quantitative data: contextual mapping survey (n = 20), health visitor survey (n = 284), health visitor records from 20 clusters and intervention website statistics. Qualitative data: dialogue meetings (n = 7), focus groups (n = 3) and interviews (n = 8).ResultsOverall, the intervention was delivered as planned to intended recipients, with few exceptions. Health visitors responded positively to the intervention, noting that it fitted well within their usual practice and enhanced families’ chances of breastfeeding. Mothers expressed having received the intervention with few exceptions, and reacted positively to the intervention. Although health visitors were concerned about the potential stigmatisation of mothers receiving the intensified intervention, none of the interviewed mothers felt stigmatised. Contextual factors impacting the intervention implementation and mechanisms included staff and management turnover, project infrastructure and mothers’ context, such as resources, social networks and previous experiences. The overall fidelity of the intervention delivery was high.ConclusionsHealth visitors and families responded well to the intervention. Interventions aimed at enabling health care providers to deliver simplified and structured breastfeeding support, in alignment with support provided in other sectors of the health care system, may increase breastfeeding rates and reduce social inequity in breastfeeding, even in international contexts.Trial registrationClinical Trials: NCT05311631. First posted April 5, 2022.

5-Fluorouracil induces apoptosis in nutritional deprived hepatocellular carcinoma through mitochondrial damage.

5-Fluorouracil (5-FU) is the leading chemotherapeutic drug used to treat hepatocellular carcinoma, one of the major cancer diseases after atherosclerosis. Because of chemo-resistance, the success rate of treatment declines with time due to continuous drug exposure. Though autophagy induction is majorly responsible for acquired resistance, the exact role of this evolutionary conserved mechanism is unknown in cancer cell survival and suppression. The usual practice involves the combinatorial use of chemotherapeutic drugs with autophagy inhibitors like Chloroquine and Bafilomycin A, while neglecting the side effects caused by autophagy impairment in healthy cells. Starvation is a well-known physiological inducer of autophagy. In this study, by caloric modulation, we tried to circumvent the resistance imposed by prolonged drug exposure and investigated the effect of 5-FU in nutrient-sufficient and deficient conditions. Our findings show a substantial correlation between autophagy and increased cancer cell death in the presence of 5-FU, with negligible effects on normal cells. Experimental data revealed that nutritional deprivation augmented cell death in the presence of 5-FU through mitochondrial membrane damage and excessive reactive oxygen species (ROS) production, initiating apoptosis. Lipidation study also unveiled that under such combinatorial treatment cellular metabolism shifts from glucose to lipid biosynthesis. Overall, our experimental findings suggest that nutritional deprivation in combination with chemotherapeutic medication can be a new effective strategy to control hepatocellular carcinoma.

Emotional competence self-help app versus cognitive behavioural self-help app versus self-monitoring app to prevent depression in young adults with elevated risk (ECoWeB PREVENT): an international, multicentre, parallel, open-label, randomised controlled trial.

Effective, scalable interventions are needed to prevent poor mental health in young people. Although mental health apps can provide scalable prevention, few have been rigorously tested in high-powered trials built on models of healthy emotional functioning or tailored to individual profiles. We aimed to test a personalised emotional competence app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to prevent an increase in depression symptoms in young people. This multicentre, parallel, open-label, randomised controlled trial, within a cohort multiple randomised trial (including a parallel trial of wellbeing promotion) was done at four university trial sites in the UK, Germany, Spain, and Belgium. Participants were recruited from schools, universities, and social media from the four respective countries. Eligible participants were aged 16-22 years with increased vulnerability indexed by baseline emotional competence profile, without current or past diagnosis of major depression. Participants were randomly assigned (1:1:1) to usual practice plus either the personalised emotional competence self-help app, the generic CBT self-help app, or the self-monitoring app by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. Outcome assessors were masked to group allocation. The primary outcome was depression symptoms (according to Patient Health Questionnaire-9 [PHQ-9]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed. Between Oct 15, 2020, and Aug 3, 2021, 1262 participants were enrolled, including 417 to the emotional competence app, 423 to the CBT app, and 422 to the self-monitoring app. Mean age was 18·8 years (SD 2·0). Of 1262 participants self-reporting gender, 984 (78·0%) were female, 253 (20·0%) were male, 15 (1·2%) were neither, and ten (0·8%) were both. 178 participants in the emotional competence app group, 191 in the CBT app group, and 199 in the self-monitoring app group completed the follow-up assessment at 3 months. At 3 months, depression symptoms were lower with the CBT app than the self-monitoring app (mean difference in PHQ-9 -1·18 [95% CI -2·01 to -0·34]; p=0·006), but depression symptoms did not differ between the emotional competence app and the CBT app (0·63 [-0·22 to 1·49]; p=0·15) or the self-monitoring app and emotional competence app (-0·54 [-1·39 to 0·31]; p=0·21). 31 of the 541 participants who completed any of the follow-up assessments received treatment in hospital or were admitted to hospital for mental health-related reasons considered unrelated to interventions (eight in the emotional competence app group, 15 in the CBT app group, and eight in the self-monitoring app group). No deaths occurred. The CBT app delayed increases in depression symptoms in at-risk young people relative to the self-monitoring app, although this benefit faded by 12 months. Against hypotheses, the emotional competence app was not more effective at reducing depression symptoms than the self-monitoring app. CBT self-help apps might be valuable public mental health interventions for young people given their scalability, non-consumable nature, and affordability. European Commission.

Emotional competence self-help mobile phone app versus cognitive behavioural self-help app versus self-monitoring app to promote mental wellbeing in healthy young adults (ECoWeB PROMOTE): an international, multicentre, parallel, open-label, randomised controlled trial.

Based on evidence that mental health is more than an absence of mental disorders, there have been calls to find ways to promote flourishing at a population level, especially in young people, which requires effective and scalable interventions. Despite their potential for scalability, few mental wellbeing apps have been rigorously tested in high-powered trials, derived from models of healthy emotional functioning, or tailored to individual profiles. We aimed to test a personalised emotional competence self-help app versus a cognitive behavioural therapy (CBT) self-help app versus a self-monitoring app to promote mental wellbeing in healthy young people. This international, multicentre, parallel, open-label, randomised controlled trial within a cohort multiple randomised trial (including a parallel trial of depression prevention) was done at four university trial sites in four countries (the UK, Germany, Spain, and Belgium). Participants were recruited from schools and universities and via social media from the four respective countries. Eligible participants were aged 16-22 years with well adjusted emotional competence profiles and no current or past diagnosis of major depression. Participants were randomised (1:1:1) to usual practice plus either the emotional competence app, the CBT app or the self-monitoring app, by an independent computerised system, minimised by country, age, and self-reported gender, and followed up for 12 months post-randomisation. The primary outcome was mental wellbeing (indexed by the Warwick-Edinburgh Mental Well Being Scale [WEMWBS]) at 3-month follow-up, analysed in participants who completed the 3-month follow-up assessment. Outcome assessors were masked to group allocation. The study is registered with ClinicalTrials.gov, NCT04148508, and is closed. Between Oct 15, 2020, and Aug 3, 2021, 2532 participants were enrolled, and 847 were randomly assigned to the emotional competence app, 841 to the CBT app, and 844 to the self-monitoring app. Mean age was 19·2 years (SD 1·8). Of 2532 participants self-reporting gender, 1896 (74·9%) were female, 613 (24·2%) were male, 16 (0·6%) were neither, and seven (0·3%) were both. 425 participants in the emotional competence app group, 443 in the CT app group, and 447 in the self-monitoring app group completed the follow-up assessment at 3 months. There was no difference in mental wellbeing between the groups at 3 months (global p=0·47). The emotional competence app did not differ from the CBT app (mean difference in WEMWBS -0·21 [95% CI -1·08 to 0·66]) or the self-monitoring app (0·32 [-0·54 to 1·19]) and the CBT app did not differ from the self-monitoring app (0·53 [-0·33 to 1·39]). 14 of 1315 participants were admitted to or treated in hospital (or both) for mental health-related reasons, which were considered unrelated to the interventions (five participants in the emotional competence app group, eight in the CBT app group, and one in the self-monitoring app group). No deaths occurred. The emotional competence app and the CBT app provided limited benefit in promoting mental wellbeing in healthy young people. This finding might reflect the low intensity of these interventions and the difficulty improving mental wellbeing via universal digital interventions implemented in low-risk populations. European Commission.