Quasi-perfusion studies for intensified lentiviral vector production using a continuous stable producer cell line.

Quasi-perfusion culture was employed to intensify lentiviral vector (LV) manufacturing using a continuous stable producer cell line in an 8-day process. Initial studies aimed to identify a scalable seeding density, with 3, 4, and 5 × 104 cells cm-2 providing similar specific productivities of infectious LV. Seeding at 3 × 104 cells cm-2 was selected, and the quasi-perfusion was modulated to minimize inhibitory metabolite accumulation and vector exposure at 37°C. Similar specific productivities of infectious LV and physical LV were achieved at 1, 2, and 3 vessel volumes per day (VVD), with 1 VVD selected to minimize downstream processing volumes. The optimized process was scaled 50-fold to 1,264 cm2 flasks, achieving similar LV titers. However, scaling up beyond this to a 6,320 cm2 multilayer flask reduced titers, possibly from suboptimal gas exchange. Across three independent processes in 25 cm2 to 6,320 cm2 flasks, reproducibility was high with a coefficient of variation of 7.7% ± 2.9% and 11.9% ± 3.0% for infectious and physical LV titers, respectively. The optimized flask process was successfully transferred to the iCELLis Nano (Cytiva) fixed-bed bioreactor, with quasi-perfusion at 1 VVD yielding 1.62 × 108 TU.

Continuous manufacturing of lentiviral vectors using a stable producer cell line in a fixed-bed bioreactor.

Continuous manufacturing of lentiviral vectors (LVs) using stable producer cell lines could extend production periods, improve batch-to-batch reproducibility, and eliminate costly plasmid DNA and transfection reagents. A continuous process was established by expanding cells constitutively expressing third-generation LVs in the iCELLis Nano fixed-bed bioreactor. Fixed-bed bioreactors provide scalable expansion of adherent cells and enable a straightforward transition from traditional surface-based culture vessels. At 0.5 vessel volume per day (VVD), the short half-life of LVs resulted in a low total infectious titer at 1.36 × 104 TU cm-2. Higher perfusion rates increased titers, peaking at 7.87 × 104 TU cm-2 at 1.5 VVD. The supernatant at 0.5 VVD had a physical-to-infectious particle ratio of 659, whereas this was 166 ± 15 at 1, 1.5, and 2 VVD. Reducing the pH from 7.20 to 6.85 at 1.5 VVD improved the total infectious yield to 9.10 × 104 TU cm-2. Three independent runs at 1.5 VVD and a culture pH of 6.85 showed low batch-to-batch variability, with a coefficient of variation of 6.4% and 10.0% for total infectious and physical LV yield, respectively. This study demonstrated the manufacture of high-quality LV supernatant using a stable producer cell line that does not require induction.

Clinical outcomes and prognostic factors in Acanthamoeba keratitis.

PURPOSE: To report clinical findings and prognostic factors for visual and morphological outcomes in patients with Acanthamoeba keratitis (AK). METHODS: Single-center, retrospective, longitudinal study of 51 cases of AK diagnosed by real-time polymerase chain reaction (RT-PCR) between March 2010 and October 2022. The primary outcome was the final best corrected visual acuity (BCVA). Poor visual outcome was defined as a final BCVA ≥ 1 logMAR unit, while good visual outcome was defined as a final BCVA < 1 logMAR unit. Eyes from these two groups were compared, regarding demographic and initial clinical variables, anti-Acanthamoeba treatment used, and complications of the disease. Early diagnosis was defined as ≤ 14 days from symptom onset to diagnostic confirmation and initiation of Acanthamoeba medical treatment. Multivariable logistic regression was used to determine predictors of poor visual outcome. RESULTS: A total of 51 eyes from 46 patients diagnosed with AK, all contact lens (CL) wearers, were included in this study. Average follow-up was 39.0 ± 30.2 [total range 14-120] months. Thirty-one eyes (60.8 %) presented good visual outcome, with a lower baseline age (30.5 ± 9.0 vs. 42.3 ± 15.8; p = 0.020), better initial BCVA (0.8 ± 0.7 logMAR units vs. 1.3 ± 0.9 logMAR units; p = 0.047), higher rate of early diagnosis (45.2 % vs. 5.6 %; p = 0.004), and higher rate of therapeutic epithelial debridement (64.5 % vs. 10 %; p < 0.001). 20 eyes (39.2 %) presented poor visual outcome, with 12 eyes undergoing evisceration/enucleation (23.5 %). These 20 eyes presented a higher rate of complications (90 % vs. 61.3 %; p = 0.031). In multivariable analysis, early diagnosis of AK (OR 19.78; 95 % CI 2.07-189.11; p = 0.010) and therapeutic epithelial debridement (OR 19.02; 95 % CI 3.27-110.57; p = 0.001) were associated with a good visual outcome. CONCLUSIONS: In the present study, poor visual outcome was present in 39 % of affected eyes. Early AK diagnosis (≤14 days from symptom onset) and therapeutic epithelial debridement were associated with good final visual outcome.

Recommendations of good practice to prevent aspiration pneumonia in older adults at risk of oropharyngeal dysphagia living in nursing homes: A modified e-Delphi study protocol.

BACKGROUND: Aspiration pneumonia (AP) is a subset of pneumonia caused by the aspiration of food and fluids to the lungs and is highly prevalent in the older population. Oropharyngeal dysphagia (OD) is one of the risk factors for AP and it is also associated with malnutrition, dehydration and poor functional outcomes. As pneumonia is the second most common infection in nursing homes (NHs) and OD represents a major concern to NH staff, good practices for the prevention of AP in older adults at risk of OD are needed. PURPOSE: The aim of this modified e-Delphi study is to build consensus among a panel of experts regarding a set of recommendations for NH staff on good practices to prevent AP in older adults at risk of OD living in NHs. The objective of this paper is to establish the methodology inherent to the Delphi study. METHODS: An online modified Delphi study will be developed in three rounds. Criteria for the Delphi panel participants include holding a master's or doctoral degree in OD or speech and language therapy; or having 10 or more years of experience in OD; or having at least one scientific publication related to OD. A previously described modified Delphi methodology will be used to achieve consensus (75% agreement). An additional round will be performed to collect the experts' perspectives regarding the priority for application of each recommendation previously validated. DISCUSSION: This protocol aimed to describe the methodology of a future Delphi study on the prevention of AP, seeking to fulfil the gap in the literature regarding this topic. The modified Delphi technique is a widely used method for collecting experts' opinion in health sciences, but the absence of standardised guidelines allows some heterogeneity between studies with the same aim. WHAT THIS PAPER ADDS: What is already known on the subject Aspiration pneumonia (AP) is related to three main risk factors: impaired safety of swallow, impaired nutritional status and poor oral health. It is known that being dependent for feeding is one of the main risk factors for AP and around 50% of nursing home (NH) residents need feeding assistance. Thus, it is important to promote specialised intervention and care by the NH staff for preventing AP. What this paper adds to existing knowledge It is hypothesised that increasing the knowledge of NH staff regarding the best practices for preventing AP in older adults at risk of oropharyngeal dysphagia (OD) will improve outcomes such as quality of life, incidence of AP and mortality. What are the potential or actual clinical implications of this work? The recommendations resulting from this study will address a current gap in healthcare practice of NH staff regarding older adults at increased risk for OD and, consequently, for AP.

Scalable manufacturing of gene-modified human mesenchymal stromal cells with microcarriers in spinner flasks.

Due to their immunomodulatory properties and in vitro differentiation ability, human mesenchymal stromal cells (hMSCs) have been investigated in more than 1000 clinical trials over the last decade. Multiple studies that have explored the development of gene-modified hMSC-based products are now reaching early stages of clinical trial programmes. From an engineering perspective, the challenge lies in developing manufacturing methods capable of producing sufficient doses of ex vivo gene-modified hMSCs for clinical applications. This work demonstrates, for the first time, a scalable manufacturing process using a microcarrier-bioreactor system for the expansion of gene-modified hMSCs. Upon isolation, umbilical cord tissue mesenchymal stromal cells (UCT-hMSCs) were transduced using a lentiviral vector (LV) with green fluorescent protein (GFP) or vascular endothelial growth factor (VEGF) transgenes. The cells were then seeded in 100 mL spinner flasks using Spherecol microcarriers and expanded for seven days. After six days in culture, both non-transduced and transduced cell populations attained comparable maximum cell concentrations (≈1.8 × 105 cell/mL). Analysis of the culture supernatant identified that glucose was fully depleted after day five across the cell populations. Lactate concentrations observed throughout the culture reached a maximum of 7.5 mM on day seven. Immunophenotype analysis revealed that the transduction followed by an expansion step was not responsible for the downregulation of the cell surface receptors used to identify hMSCs. The levels of CD73, CD90, and CD105 expressing cells were above 90% for the non-transduced and transduced cells. In addition, the expression of negative markers (CD11b, CD19, CD34, CD45, and HLA-DR) was also shown to be below 5%, which is aligned with the criteria established for hMSCs by the International Society for Cell and Gene Therapy (ISCT). This work provides a foundation for the scalable manufacturing of gene-modified hMSCs which will overcome a significant translational and commercial bottleneck. KEY POINTS: • hMSCs were successfully transduced by lentiviral vectors carrying two different transgenes: GFP and VEGF • Transduced hMSCs were successfully expanded on microcarriers using spinner flasks during a period of 7 days • The genetic modification step did not cause any detrimental impact on the hMSC immunophenotype characteristics.

Systematic review and meta-analysis of cell therapy for COVID-19: global clinical trial landscape, published safety/efficacy outcomes, cell product manufacturing and clinical delivery.

During the pandemic of severe respiratory distress syndrome coronavirus 2 (SARS-CoV2), many novel therapeutic modalities to treat Coronavirus 2019 induced disease (COVID-19) were explored. This study summarizes 195 clinical trials of advanced cell therapies targeting COVID-19 that were registered over the two years between January 2020 to December 2021. In addition, this work also analyzed the cell manufacturing and clinical delivery experience of 26 trials that published their outcomes by July 2022. Our demographic analysis found the highest number of cell therapy trials for COVID-19 was in United States, China, and Iran (N=53, 43, and 19, respectively), with the highest number per capita in Israel, Spain, Iran, Australia, and Sweden (N=0.641, 0.232, 0,223, 0.194, and 0.192 trials per million inhabitants). The leading cell types were multipotent mesenchymal stromal/stem cells (MSCs), natural killer (NK) cells, and mononuclear cells (MNCs), accounting for 72%, 9%, and 6% of the studies, respectively. There were 24 published clinical trials that reported on infusions of MSCs. A pooled analysis of these MSC studies found that MSCs provide a relative risk reduction for all-cause COVID-19 mortality of RR=0.63 (95% CI 0.46 to 0.85). This result corroborates previously published smaller meta-analyses, which suggested that MSC therapy demonstrated a clinical benefit for COVID-19 patients. The sources of the MSCs used in these studies and their manufacturing and clinical delivery methods were remarkably heterogeneous, with some predominance of perinatal tissue-derived products. Our results highlight the important role that cell therapy products may play as an adjunct therapy in the management of COVID-19 and its related complications, as well as the importance of controlling key manufacturing parameters to ensure comparability between studies. Thus, we support ongoing calls for a global registry of clinical studies with MSC products that could better link cell product manufacturing and delivery methods to clinical outcomes. Although advanced cell therapies may provide an important adjunct treatment for patients affected by COVID-19 in the near future, preventing pathology through vaccination still remains the best protection to date. We conducted a systematic review and meta-analysis of advanced cell therapy clinical trials as potential novel treatment for COVID-19 (resulting from SARS-CoV-2 coronavirus infection), including analysis of the global clinical trial landscape, published safety/efficacy outcomes (RR/OR), and details on cell product manufacturing and clinical delivery. This study had a 2-year observation interval from start of January 2020 to end of December 2021, including a follow-up period until end of July to identify published outcomes, which covers the most vivid period of clinical trial activity, and is also the longest observation period studied until today. In total, we identified 195 registered advanced cell therapy studies for COVID-19, employing 204 individual cell products. Leading registered trial activity was attributed to the USA, China, and Iran. Through the end of July 2022, 26 clinical trials were published, with 24 out of 26 articles employing intravenous infusions (IV) of mesenchymal stromal/stem cell (MSC) products. Most of the published trials were attributed to China and Iran. The cumulative results from the 24 published studies employing infusions of MSCs indicated an improved survival (RR=0.63 with 95% Confidence Interval 0.46 to 0.85). Our study is the most comprehensive systematic review and meta-analysis on cell therapy trials for COVID-19 conducted to date, clearly identifying the USA, China, and Iran as leading advanced cell therapy trial countries for COVID-19, with further strong contributions from Israel, Spain, Australia and Sweden. Although advanced cell therapies may provide an important adjunct treatment for patients affected by COVID-19 in the future, preventing pathology through vaccination remains the best protection.

Understanding the impact of bioactive coating materials for human mesenchymal stromal cells and implications for manufacturing.

Bioactive materials interact with cells and modulate their characteristics which enable the generation of cell-based products with desired specifications. However, their evaluation and impact are often overlooked when establishing a cell therapy manufacturing process. In this study, we investigated the role of different surfaces for tissue culture including, untreated polystyrene surface, uncoated Cyclic Olefin Polymer (COP) and COP coated with collagen and recombinant fibronectin. It was observed that human mesenchymal stromal cells (hMSCs) expanded on COP-coated plates with different bioactive materials resulted in improved cell growth kinetics compared to traditional polystyrene plates and non-coated COP plates. The doubling time obtained was 2.78 and 3.02 days for hMSC seeded in COP plates coated with collagen type I and recombinant fibronectin respectively, and 4.64 days for cells plated in standard polystyrene treated plates. Metabolite analysis reinforced the findings of the growth kinetic studies, specifically that cells cultured on COP plates coated with collagen I and fibronectin exhibited improved growth as evidenced by a higher lactate production rate (9.38 × 105 and 9.67 × 105 pmol/cell/day, respectively) compared to cells from the polystyrene group (5.86 × 105 pmol/cell/day). This study demonstrated that COP is an effective alternative to polystyrene-treated plates when coated with bioactive materials such as collagen and fibronectin, however COP-treated plates without additional coatings were found not to be sufficient to support cell growth. These findings demonstrate the key role biomaterials play in the cell manufacturing process and the importance of optimising this selection.

Impact of Wound Dressing Changes on Nursing Workload in an Intensive Care Unit.

The objective of this study is to understand how the type of wound dressing changes (routine or frequent) in patients admitted to intensive care units influences nurses' workload. This study used a database of retrospective and analytical observational study from one Portuguese intensive care unit. The sample included 728 adult patients admitted between 2015 and 2019. The nursing workload was assessed by the TISS-28 scale, both at admission and at discharge. The linear regression results show that patients with frequent dressing changes are associated with a higher nursing workload, both at admission (Coef. 1.65; 95% CI [0.53; 2.77]) and discharge (Coef. 1.27; 95% CI [0.32; 2.22]). In addition, age influences the nursing workload; older people are associated with a higher nursing workload (at admission Coef. 0.07; 95% CI [0.04; 0.10]; at discharge Coef. 0.08; 95% CI [0.05; 0.10]). Additionally, an increase in nursing workload at admission would significantly increase the nursing workload at discharge (Coef. 0.27; 95% CI [0.21; 0.33]). The relative stability of the nursing workload over the studied years is also another important finding (the influence of studied years is non-significant). In conclusion, patients with frequent dressing changes presented higher TISS-28 scores when compared with patients with an exchange of routine dressings, which leads to a higher nursing workload.

A Comprehensive Analysis of Age and Gender Effects in European Portuguese Oral Vowels.

The knowledge about the age effects in speech acoustics is still disperse and incomplete. This study extends the analyses of the effects of age and gender on acoustics of European Portuguese (EP) oral vowels, in order to complement initial studies with limited sets of acoustic parameters, and to further investigate unclear or inconsistent results. A database of EP vowels produced by a group of 113 adults, aged between 35 and 97, was used. Duration, fundamental frequency (f0), formant frequencies (F1 to F3), and a selection of vowel space metrics (F1 and F2 range ratios, vowel articulation index [VAI] and formant centralization ratio [FCR]) were analyzed. To avoid the arguable division into age groups, the analyses considered age as a continuous variable. The most relevant age-related results included: vowel duration increase in both genders; a general tendency to formant frequencies decrease for females; changes that were consistent with vowel centralization for males, confirmed by the vowel space acoustic indexes; and no evidence of F3 decrease with age, in both genders. This study has contributed to knowledge on aging speech, providing new information for an additional language. The results corroborated that acoustic characteristics of speech change with age and present different patterns between genders.

Anti-Algics in the Therapeutic Response of Breast and Urological Cancers.

The effect of anti-algics on tumor progression and the overall survival of patients is controversial and remains unclear. Herein, we disclose the in vitro effects of the local anesthetics lidocaine, ropivacaine, and levobupivacaine on breast (MCF7), prostate (PC3, LNCaP), and bladder (TCCSUP, HT1376) cancer cell lines, both as monotherapy and in combination with standard-of-care therapeutics. Assays for cell proliferation, viability, death profile, and migration were performed. Additionally, we explored the clinical outcomes of opioid use through a cross-sectional study involving 200 metastatic prostate cancer patients. The main clinical data collected included the type of opioid therapy administered, dosage, treatment duration, disease progression, and overall survival. Results obtained demonstrate that treatment with local anesthetics has a promising selective anti-tumor effect on these types of cancer, with higher effects when associated with docetaxel. This points out the use of local anesthetics as an added value in the treatment of prostate carcinoma patients. Alternatively, chronic opioid use was correlated with reduced overall survival (p < 0.05) and progression-free survival (p < 0.05) at each treatment line in the observational study. While these results provide valuable insights, larger prospective studies are imperative to comprehensively evaluate the clinical impact of opioid analgesics in prostate cancer patients.

The Effects of the Pragmatic Intervention Programme in Children with Autism Spectrum Disorder and Developmental Language Disorder.

PURPOSE: Children with Autism Spectrum Disorder (ASD) and Developmental Language Disorder (DLD) frequently face pragmatic impairments which may result in learning, socialization, and mental health difficulties, therefore early intervention is crucial. In Portugal, the Pragmatic Intervention Programme (PICP) has been recently developed and validated, but its effects are unknown. This study aims to determine the effects of the PICP on preschool-age children with ASD or DLD with pragmatic impairments. METHODS: A non-randomized controlled trial has been conducted. The children (n = 20) were assigned to the intervention (n = 11) or the control group (waiting list) (n = 9). Each child attended 24 PICP-based intervention sessions provided by a Speech and Language Therapist in kindergarten. The primary outcome measure was a Goal Attainment Scale (GAS) rated by parents and kindergarten teachers. Secondary outcomes include parent/teacher-reported communication skills (Escala de Avaliação de Competências Comunicativas) and an assessment of the child's general language ability (Teste de Linguagem-Avaliação da Linguagem Pré-Escolar). RESULTS: GAS results show that all the children in the intervention group made progress. Statistically significant differences between pre- and post-intervention assessments were found for all secondary outcomes. CONCLUSIONS: The main findings suggest that the PICP improves language in preschool-age children with ASD and DLD with pragmatic difficulties. Further research is needed to analyse the effects of the PICP for each neurodevelopmental disorder individually. These results are crucial and will contribute to future research and evidence-based practice.

Perinatal derivatives application: Identifying possibilities for clinical use.

Perinatal derivatives are drawing growing interest among the scientific community as an unrestricted source of multipotent stromal cells, stem cells, cellular soluble mediators, and biological matrices. They are useful for the treatment of diseases that currently have limited or no effective therapeutic options by means of developing regenerative approaches. In this paper, to generate a complete view of the state of the art, a comprehensive 10-years compilation of clinical-trial data with the common denominator of PnD usage has been discussed, including commercialized products. A set of criteria was delineated to challenge the 10-years compilation of clinical trials data. We focused our attention on several aspects including, but not limited to, treated disorders, minimal or substantial manipulation, route of administration, dosage, and frequency of application. Interestingly, a clear correlation of PnD products was observed within conditions, way of administration or dosage, suggesting there is a consolidated clinical practice approach for the use of PnD in medicine. No regulatory aspects could be read from the database since this information is not mandatory for registration. The database will be publicly available for consultation. In summary, the main aims of this position paper are to show possibilities for clinical application of PnD and propose an approach for clinical trial preparation and registration in a uniform and standardized way. For this purpose, a questionnaire was created compiling different sections that are relevant when starting a new clinical trial using PnD. More importantly, we want to bring the attention of the medical community to the perinatal products as a consolidated and efficient alternative for their use as a new standard of care in the clinical practice.

The Volume-Viscosity Swallowing Test – Portuguese Version: Validation and prevalence of safety and efficacy clinical signs in acute stroke patients / La prueba de deglución volumen-viscosidad - versión portuguesa: validación y prevalencia de seguridad y signos clínicos de eficacia en pacientes con accidente cerebrovascular agudo

Purpose:The early identification of oropharyngeal dysphagia (OD) in patients after an acute stroke using non-invasive and easily administered instruments can minimize its consequences and reduce comorbidity and mortality. The Volume-Viscosity Swallow Test (V-VST) is a screening test that makes it possible. The goal of this study is to contribute to the validation of the V-VST European Portuguese (V-VST: EP) version and study the prevalence of safety and efficacy signs in acute stroke patients. Method: The V-VST: EP, its instructions manual and algorithm, was presented to a panel of experts, to assess its content validity. It was applied to 33 acute stroke patients, with signs of OD, to analyze its psychometric properties. Finally, the prevalence of impaired signs of safety and efficacy was analyzed. Results: The V-VST: EP and its instruction manual (content) demonstrate very good agreement values. Most of the results for inter and intra-evaluator reliability presented Cohen's kappa values higher than 0.60 or 0.80 (75.0%). The concurrent validity (against the 3 OZ wst) presented a sensitivity of 100% and a specificity of 57.1%. For evaluator 1, the results presented are for the nectar, liquid and pudding consistencies, the prevalence values for the 5 ml, 10 ml and 20 ml volume capacity was: impaired lip closure (36%, 39%, 18%), piecemeal deglutition (50%, 50%, 50%), oral residue (7%, 0%, 9%), pharyngeal residue (25%, 17%, 9%) and safe swallowing (89%, 33%, 94%), respectively.(AU)

Propósito: La identificación temprana de la disfagia orofaríngea (DO) en pacientes después de un accidente cerebrovascular, utilizando instrumentos no invasivos y de fácil administración, puede minimizar sus consecuencias y reducir la comorbilidad y la mortalidad. El examen Volume-Viscosity Swallow Test (V-VST) es una prueba de detección que lo hace posible. El objetivo de este estudio es contribuir para la validación del V-VST Versión en portugués europeo (V-VST: EP) y estudio de prevalencia de signos de seguridad y eficacia en pacientes con ictus agudo. Método: Se presentó el V-VST: EP, su manual de instrucciones y algoritmo, a un panel de expertos, para evaluar su validez de contenido. Se aplicó a 33 pacientes con ictus agudo, con signos de DO, para analizar sus propiedades psicométricas. Finalmentese analizó la prevalencia de señales de deterioro de seguridad y eficacia. Resultados: El V-VST: EP y su manual de instrucciones (contenido) demuestran valores demuy buenaconcordancia. La mayoría de los resultados de confiabilidad inter e intra evaluador presentaron valoreskappa de Cohen superiores a 0,60 o 0,80 (75,0%). La validez concurrente (contra el peso de 3 OZ) presentada una sensibilidad del 100% y una especificidad del 57,1%. Para el evaluador 1, los resultados presentados son para las consistencias de néctar, líquido y budín, los valores de prevalencia para los 5 ml, 10 ml y 20 ml capacidad de volumen fue: deterioro del cierre de los labios (36%, 39%, 18%), deglución fragmentaria (50%, 50%, 50%), residuo oral (7%, 0%, 9%), residuo faríngeo (25%, 17%, 9%) y deglución segura (89%, 33%, 94%), respectivamente.(AU)

Blended-Learning Pain Neuroscience Education and Exercise in High School Students With Chronic Neck Pain: A Randomized Controlled Trial.

OBJECTIVE: Pain neuroscience education (PNE) and exercise have emerged as potential interventions in adolescents with chronic pain; however, very few studies have explored their effectiveness. Blended-learning approaches combining face-to-face and online educational sessions have also emerged as facilitating methods of health education. This study aimed to compare the effectiveness of exercises and PNE versus exercise alone in adolescents with chronic neck pain (NP). METHODS: A randomized controlled trial with 6-month follow-up was conducted in 2 high schools. Over 8 weeks, a total of 127 adolescents with chronic NP were randomly allocated to either (1) perform functional and region-specific exercises, including generalized neuromuscular control, endurance, and strength exercises, as well as exercises targeting the deep neck flexor and extensor muscles and scapular stabilizer muscles; or (2) perform the same exercise-based intervention plus PNE. Pain intensity (primary outcome), disability, sleep, catastrophizing, fear of movement, self-efficacy, and knowledge of pain neuroscience were assessed at baseline, postintervention, and 6-month follow-up. Neck and scapular muscle endurance and pressure pain thresholds were assessed at baseline and postintervention. Patient's Global Impression of Change was assessed postintervention and at 6-month follow-up. RESULTS: There was a significant decrease in pain intensity from baseline to postintervention and from baseline to follow-up in both groups, but there were no between-group differences or interactions between time and groups. These results were similar for the secondary outcomes, except for knowledge of pain neuroscience, for which a significant group and time interaction was found. CONCLUSION: Exercise and exercise plus PNE were similarly effective in treating adolescents with chronic NP, and the results were maintained for up to 6 months. Further studies are needed to explore the effect of these interventions for longer follow-ups.

Development of the European Portuguese version of the oral health assessment tool: Content validity and reliability study in an elderly population.

AIMS: Poor oral health is a risk factor for aspiration pneumonia (AP), especially in elderly patients at risk of oropharyngeal dysphagia (OD). In Portugal, available tools to screen oral problems in nursing homes are scarce. The oral health assessment tool (OHAT) is a screening tool that assesses elderly residents' oral health. This study aims to translate and validate the tool for the European Portuguese (EP) context. METHODS: The original version was translated into EP throughout a forward-backward translation process. An instruction manual was created. Content of both documents were assessed by a panel of eight experts. The content validity Index was calculated. A reliability study was conducted in three nursing homes by two speech and language therapists in two different moments, separated by 48 h. RESULTS: A sample of 30 institutionalized elderly with a mean age of 77 years was analyzed. The EP version and its instruction manual presented a content validity Index greater than 0.88 in all its items. Total scores showed excellent inter-rater and good intra-rater results. CONCLUSION: The EP version showed to be a reliable and valid tool for the screening of oral health conditions of institutionalized older adults at risk of OD.

Predictors of frailty in older people users of Primary Health Care.

OBJECTIVE: to identify the prevalence and predictors of frailty in older people in Primary Health Care. METHOD: this is a descriptive and correlational study, carried out in a convenience sample of 136 older people in the community. Data were collected through a sociodemographic and clinical questionnaire and frailty phenotype. Student's t test or U-Mann-Whitney test, chi-square and binary logistic regression were used for data analysis. RESULTS: the prevalence of frailty was 26.5% (n=36). Frail individuals had older age (p=0.011), worse self-rated health (p=0.001) and lower physical capacity (p<0.001). In the multivariable regression, it was observed that frail individuals had older age (Odds Ratio=1.111; 95% confidence interval=1.026-1.203) and worse physical capacity (Odds Ratio=0.673; 95% confidence interval=0.508-0.893). CONCLUSIONS: the prevalence of frailty in older people in Primary Health Care was considerable. Advanced age and worse physical capacity were the most relevant predictors of frailty in the elderly.

Factors Associated with Cardiovascular Disease Risk among Employees at a Portuguese Higher Education Institution.

This study aimed to estimate the prevalence of risk factors for cardiovascular disease (CVD) and to assess the CVD risk (CVDRisk) in a sample of workers at a specific workplace: a higher education institution in Portugal. Data were collected using a questionnaire (e.cuidHaMUs.QueST®) with 345 HEI workers from June 2017-June 2018 with a high response rate (93.3%). Two constructs of risks for CVD were considered: (i) metabolic risk and hypertension (CVDRisk1); and (ii) modifiable behavioural risk (CVDRisk2). Logistic regression analyses were used to establish a relationship between risk indexes/constructs (CVDRisk1 and CVDRisk2) and groups of selected variables. The most prevalent CVD risk factor was hypercholesterolaemia (43.2%). Sixty-eight percent of participants were in the construct CVDRisk1 while almost half of the respondents were in CVDRisk2 (45.2%). The consumption of soft drinks twice a week or more contributed to a significantly increased risk of CVD in CVDRisk1. Lack of regular exercise and lack of daily fruit consumption significantly increased the risk of CVD in CVDRisk2. The challenge to decision makers and the occupational medical community is to incorporate this information into the daily practices of health surveillance with an urgent need for health promotional education campaigns in the workplace.

Description of an integrated e-health monitoring system in a Portuguese higher education institution: the e.cuidHaMUstm program.

BACKGROUND: The World Health Organization and the International Labour Organization recognize that workplace health is not only affected by occupational hazards, but is mainly affected by social determinants and individual factors. An accelerated rise in noncommunicable diseases has fostered the importance of creating supportive environments and encouraging healthy behaviours. Therefore, an operational approach to making workplaces healthy and sustainable is needed. This paper describes the development of an e-Health monitoring program entitled 'Integrated eHealth Monitoring System for Health Management in Universities' (e.cuidHaMUsTM) as a possible solution to that operational approach. METHODS: We developed the program e.cuidHaMUsTM that proposes to detect risk behaviours related to noncommunicable diseases and to implement problem-solving measures by establishing a health-promoting workspace in a Portuguese higher education institution. Based on the 'I-Change' conceptual model, our program provides personalized feedback; improves health-related knowledge, attitude and good practices; and encourages actions to promote healthy lifestyles through individual health capacitation. Focusing on evaluation as an activity that generates knowledge, the e.cuidHaMUsTM program aggregates all the relevant health information, shares the results with decision-makers and evaluates health-related policy changes in the workplace. DISCUSSION: This paper presents the design of the e.cuidHaMUsTM program, the development of an eHealth web platform to share information between the different stakeholders, and a questionnaire to evaluate the health status of higher education institution workers (e.cuidHaMUs.QueST®). Also, the procedures for data collection and analysis are outlined. The e.cuidHaMUsTM program can enhance health surveillance through cross-sectional and longitudinal studies and provide scientific evidence to support the envisioned interventions and promotions of healthy lifestyles. This program is an effort to incorporate a holistic culture of health-promoting workspace in higher education institution policies.

Factors Predicting Pressure Injury Incidence in Older Adults Following Elective Total Hip Arthroplasty: A Longitudinal Study.

OBJECTIVE: To identify the factors associated with pressure injury (PI) development in older adult patients who underwent elective total hip arthroplasty (THA). METHODS: A nonexperimental longitudinal prospective study was conducted with a sample of 40 patients undergoing elective THA. Patients were evaluated for PI at hospital admission, 24 hours postsurgery, at discharge, and 1 month after surgery. RESULTS: The incidence of PIs (category 1 or category 2) in this study was 7.9% 24 hours after surgery and 24.3% at discharge. The most common PI location was the sacrum/coccyx or the ischial tuberosity. This study found significant relationships between PIs and female sex (odds ratio [OR], 8.75), body fat mass percentage (OR, 1.15), and the motor score from a Functional Independence Measure scale (OR, 0.89). Finally, the following variables were also associated with PIs (P < .1): skeletal muscle mass (OR, 0.82), lower limb with osteoarthritis weight (OR, 0.61), lower limb without osteoarthritis weight (OR, 0.62), and geriatric depression scale (OR, 1.12). CONCLUSIONS: This work identifies those patients at higher risk of PI, enabling targeted prevention and treatment in the population of patients undergoing elective THA. The findings of this study are in line with extant literature and suggest that women with a higher percentage of body fat and less mobility had a higher risk of PI.

Predictors of frailty in older people users of Primary Health Care / Predictores de fragilidad en usuarios mayores de Atención Primaria de Salud / Preditores da fragilidade no idoso usuário da Atenção Primária à Saúde

ABSTRACT Objective: to identify the prevalence and predictors of frailty in older people in Primary Health Care. Method: this is a descriptive and correlational study, carried out in a convenience sample of 136 older people in the community. Data were collected through a sociodemographic and clinical questionnaire and frailty phenotype. Student's t test or U-Mann-Whitney test, chi-square and binary logistic regression were used for data analysis. Results: the prevalence of frailty was 26.5% (n=36). Frail individuals had older age (p=0.011), worse self-rated health (p=0.001) and lower physical capacity (p<0.001). In the multivariable regression, it was observed that frail individuals had older age (Odds Ratio=1.111; 95% confidence interval=1.026-1.203) and worse physical capacity (Odds Ratio=0.673; 95% confidence interval=0.508-0.893). Conclusions: the prevalence of frailty in older people in Primary Health Care was considerable. Advanced age and worse physical capacity were the most relevant predictors of frailty in the elderly.

RESUMEN Objetivo: identificar la prevalencia y predictores de fragilidad en ancianos en Atención Primaria de Salud. Método: estudio descriptivo y correlacional, realizado en una muestra de conveniencia con 136 ancianos de la comunidad. Los datos fueron recolectados a través de un cuestionario sociodemográfico, clínico y de fenotipo de fragilidad. Para el análisis de los datos se utilizaron la prueba t de Student o la prueba U-Mann-Whitney, chi-cuadrado y regresión logística binaria. Resultados: la prevalencia de fragilidad fue del 26,5% (n=36). Los ancianos frágiles eran mayores (p=0,011), peor autoevaluación de la salud (p=0,001) y menos capaces físicamente (p <0,001). En la regresión multivariante, se observó que los ancianos frágiles eran mayores (Odds Ratio=1,111; Intervalo de confianza del 95%=1,026-1,203) y peor capacidad física (Odds Ratio=0,673; Intervalo de confianza del 95%=0,508-0,893). Conclusiones: la prevalencia de fragilidad en ancianos en Atención Primaria de Salud fue considerable. La edad avanzada y la peor capacidad física fueron los predictores más relevantes de fragilidad en el anciano

RESUMO Objetivo: identificar a prevalência e preditores da fragilidade de idosos na Atenção Primária à Saúde. Método: estudo descritivo e correlacional, realizado em amostra de conveniência com 136 idosos na comunidade. Os dados foram coletados através de um questionário sociodemográfico, clínico e pelo fenótipo de fragilidade. Utilizaram-se o teste t de Student ou U-Mann-Whitney, o Qui-Quadrado e a regressão logística binária na análise dos dados. Resultados: a prevalência da fragilidade foi de 26,5% (n=36). Os idosos frágeis apresentaram idade mais avançada (p=0,011), pior autoavaliação de saúde (p=0,001) e menor capacidade física (p<0,001). Na regressão multivariável, observou-se que os idosos frágeis apresentavam idade mais avançada (Odds Ratio=1,111; Intervalo de Confiança 95%=1,026-1,203) e pior capacidade física (Odds Ratio=0,673; Intervalo de Confiança 95%=0,508-0,893). Conclusões: a prevalência da fragilidade nos idosos na Atenção Primária à Saúde foi considerável. A idade avançada e a pior capacidade física foram os preditores mais relevantes da fragilidade nos idosos.