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OBJECTIVE: To map predictors and outcome of collaboration between nurses, outcomes of a good collaboration, and the tools developed to evaluate nurse-nurse collaboration. BACKGROUND: Collaboration between nurses is an intraprofessional relationship between coworkers that is expressed through shared objectives, authority, and a decisional process. Studies on collaboration between nurses are very limited. METHODS: A scoping review was conducted through 4 databases. RESULTS: Eighteen studies were included. Nurses with higher levels of collaboration are more satisfied with their work and report less of an intention to leave their job. Greater collaboration among nurses resulted in a decrease of patient falling, hospital-acquired pressure ulcers, and a better care. Three tools have been developed to evaluate nurse-nurse collaboration: the Nurse-Nurse Collaboration Scale, the Nurse-Nurse Collaboration Behavior Scale, and the Nurse-Nurse Collaboration Between Sector. CONCLUSIONS: Further studies should be conducted to fully understand the issue of collaboration between nurses and the factors connected to it.
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Recursos Humanos de Enfermagem Hospitalar , Humanos , Comportamento Cooperativo , Intenção , Inquéritos e Questionários , Satisfação no EmpregoRESUMO
INTRODUCTION: Nurses' professional values (NPVs) and self-efficacy (SE) are two fundamental elements in nursing care that influence its professional identity, competences, resulting in changing the behaviour of professionals and their response to the patient's health needs. The various studies produced so far have not investigated a possible relationship between these two areas. Therefore, the objective of the following study is to identify and deepen the relationship between NPV and SE, in order to improve the knowledge of these issues. MATERIALS AND METHODS: An observational, correlational and multicentric study has been carried out through a questionnaire based survey. The sampling was conventional. The data collection took place through Nursing Professional Values Scale, version 3 (NPVS-3), which investigates professional values; and Nursing Professional Self-Efficacy Scale (NPSES), which investigates self-efficacy and a socio-demographic questionnaire. RESULTS: The total sample was 532 nurses and 65.6% was female, with a median age of 42 years and a median of 15 working years. Positive statistically significant correlations between the various domains of the NPVS-3 and NPSES scales were found. These relationships also emerged in the analyses between geographical areas. Overall, the relationships between self-efficacy and values were similar in all the analyses. DISCUSSION: As the professional values of nurses increase in their response to the patient's health needs, self-efficacy perceived by them increases and vice versa, significantly effecting the clinic and care outcomes of the patients and improving nursing outcomes. The stratification of the sample by geographical area regarding the relationship between age, years of work and professional values indicated that these variables strongly influence the NPV and SE of nurses. Therefore, in some contexts, more support in maintaining a stable value structure may be needed; moreover, it is necessary to incentivise nurses with more effective interventions, as an example and a basis of motivation for future generations.
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Motivação , Autoeficácia , Adulto , Feminino , Humanos , Itália , Inquéritos e QuestionáriosRESUMO
BACKGROUND: The literature emphasizes the importance of the intensive care unit (ICU) diary to fill the gaps and recover the delusional memories of patients admitted to ICU in order to build the history of their illness. The ICU diary is a measure originally intended to support the severely ill patient, but it would also seem to be useful for family members and carers. According to our analysis of the literature, this study is the first description of the contents of ICU diaries in the Italian context. AIM: The aim of the study was to describe the contents of ICU patients' diaries filled in by their caregivers, in order to explore the experience and significance attributed to the diaries. DESIGN: A qualitative longitudinal narrative investigation was conducted at an ICU during the period from April 2016 to April 2017 with a sample composed of 32 families. METHODS: The participants were caregivers selected through purposive sampling. An ICU nurse explained the study to caregivers and offered the opportunity to participate. RESULTS: The sample included 32 diaries. Through the analysis we identified seven themes: future plans and memories; the people who care for the patient and the context; the love surrounding the patient; the clinical progression of the patient and the passage of time; what happens outside the patient's life; references to the usefulness/non-usefulness of the diary; communication/reflection on the likely death of the patient. CONCLUSIONS: Some themes emerged that have never explored in the literature, and it would be necessary to understand whether the themes that emerged depend on cultural issues. RELEVANCE TO CLINICAL PRACTICE: The diaries could be adapted to the Italian context and this could make the diary a common practice in Italy as well.
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Cuidados Críticos , Unidades de Terapia Intensiva , Cuidadores , Estado Terminal , Família , Humanos , Pesquisa QualitativaRESUMO
BACKGROUND: Cardiac surgery (CS) patients spend a significant amount of time in the intensive care unit (ICU). This event can be very overwhelming, with an intense emotional impact, causing vulnerability and a sense of helplessness in patients. Currently, the in-depth description of the ICU stay experience from a patient's own perspective is little studied, especially in the CS setting and using a qualitative approach in Italy. AIMS: This study aimed to describe CS patients' lived experiences. METHODS: A qualitative phenomenological study was conducted between October 2018 and December 2019 using the interpretative phenomenological analysis approach. RESULTS: Eleven patients were interviewed during the months after discharge from the ICU. Four main themes emerged from the analysis of the interviews: (a) will not wake up anymore; (b) endless time in ICU; (c) something keeps me from breathing; and (d) "anchor in the storm." Results confirm the negative experience of patients in the ICU, mainly because of the extubating procedure. Nurses were found to play a key role in decisions, supporting and protecting patients from the psychological stress related to the ICU stay. CONCLUSION: This is the first study capturing ICU patients' lived experiences after a CS intervention with the use of interpretative phenomenology in Italy. Further investigations are warranted to systematically identify which approaches or strategies are essential to support these patients in the Italian context. RELEVANCE TO CLINICAL PRACTICE: Our study's results could be useful for tailored care delivery to meet the real needs of Italian patients in the ICU after CS and, consequently, improve the quality of nursing care and patients' outcomes.
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Procedimentos Cirúrgicos Cardíacos , Unidades de Terapia Intensiva , Cuidados Críticos/psicologia , Humanos , Pesquisa Qualitativa , Estresse PsicológicoRESUMO
BACKGROUND: Barriers to palliative care still exist in long-term care settings for older people, which can mean that people with advanced dementia may not receive of adequate palliative care in the last days of their life; instead, they may be exposed to aggressive and/or inappropriate treatments. The aim of this multicentre study was to assess the clinical interventions and care at end of life in a cohort of nursing home (NH) residents with advanced dementia in a large Italian region. METHODS: This retrospective study included a convenience sample of 29 NHs in the Lombardy Region. Data were collected from the clinical records of 482 residents with advanced dementia, who had resided in the NH for at least 6 months before death, mainly focusing on the 7 days before death. RESULTS: Most residents (97.1%) died in the NH. In the 7 days before death, 20% were fed and hydrated by mouth, and 13.4% were tube fed. A median of five, often inappropriate, drugs were prescribed. Fifty-seven percent of residents had an acknowledgement of worsening condition recorded in their clinical records, a median of 4 days before death. CONCLUSIONS: Full implementation of palliative care was not achieved in our study, possibly due to insufficient acknowledgement of the appropriateness of some drugs and interventions, and health professionals' lack of implementation of palliative interventions. Future studies should focus on how to improve care for NH residents.
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Atenção à Saúde/classificação , Demência/complicações , Fatores de Tempo , Idoso , Idoso de 80 Anos ou mais , Estudos de Coortes , Atenção à Saúde/estatística & dados numéricos , Demência/psicologia , Feminino , Humanos , Itália , Masculino , Casas de Saúde/organização & administração , Casas de Saúde/estatística & dados numéricos , Estudos RetrospectivosRESUMO
INTRODUCTION: Bedside nursing handover may be an efficient way to achieve quality nursing outcomes, supporting the personalization of care. Recent literature attests to how bedside nursing handover is perceived by cardiac patents, but the experience of nurses participating in these handovers is largely unknown. The aim of this study is to explore nurses' experiences after the implementation of bedside nursing handover in an Italian cardiac surgical ward. METHOD: A qualitative descriptive research approach was used to respond to the study aim, and the data was collected using two focus groups. RESULTS: The main themes that were identified revolved around improving nursing care, greater professionalism, effective relationships, consequences for the patient, and obstacles to change. Moreover, we found that nurses perceive bedside nursing handover to be effective in promoting patient-centred care. The nurses in our study also felt that any difficulties with the implementation of a bedside nursing handover protocol (e.g. confidentiality) should be addressed through continued nursing education. CONCLUSIONS: This study provides a valuable insight into nurses' perceptions of bedside nursing handover in a single cardiac surgery setting in Italy and is the first qualitative investigation from this perspective. Further research may help to elucidate the impact of bedside nursing handover on clinical and organisational outcomes.
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Atitude do Pessoal de Saúde , Enfermagem , Transferência da Responsabilidade pelo Paciente , Assistência Centrada no Paciente , Adulto , Humanos , Itália , Pessoa de Meia-Idade , Pesquisa Qualitativa , Centro Cirúrgico Hospitalar , Cirurgia TorácicaRESUMO
BACKGROUND:: The research question for this study was as follows: Is the Code of Ethics for Nurses in Italy (Code) a valid or useful decision-making instrument for nurses faced with ethical problems in their daily clinical practice? METHOD:: Focus groups were conducted to analyze specific ethical problems through 11 case studies. The analysis was conducted using sections of the Code as well as other relevant documents. Each focus group had a specific theme and nurses participated freely in the discussions according to their respective clinical competencies. ETHICAL CONSIDERATIONS:: The executive administrative committee of the local nursing licensing council provided approval for conducting this project. Measures were taken to protect the confidentiality of consenting participants. FINDINGS:: The answer to the research question posed for this investigation was predominantly positive. Many sections of the Code were useful for discussion and identifying possible solutions for the ethical problems presented in the 11 cases. CONCLUSION:: We concluded that the Code of Ethics for Nurses in Italy can be a valuable aid in daily practice in most clinical situations that can give rise to ethical problems.
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Códigos de Ética , Tomada de Decisões/ética , Ética em Enfermagem , Recursos Humanos de Enfermagem/psicologia , Feminino , Grupos Focais , Humanos , Itália , Masculino , Recursos Humanos de Enfermagem/estatística & dados numéricos , Reprodutibilidade dos TestesAssuntos
Betacoronavirus , Controle de Doenças Transmissíveis/organização & administração , Infecções por Coronavirus/complicações , Infecções por Coronavirus/prevenção & controle , Papel do Profissional de Enfermagem , Pandemias/prevenção & controle , Pneumonia Viral/complicações , Pneumonia Viral/prevenção & controle , Idoso , COVID-19 , Infecções por Coronavirus/epidemiologia , Humanos , Itália , Pneumonia Viral/epidemiologia , SARS-CoV-2RESUMO
INTRODUCTION: Widespread use of smartphone applications has opened new perspectives for home Blood Pressure monitoring based on mobile health (mHealth) technologies. Patient engagement has been dubbed 'the silver bullet of the century'. AIM: The aim was to identify the impact of engagement in patients with blood pressure using mHealth. METHODS: This scoping review was conducted in accordance with the Ark0sey and O'Malley framework. DATABASE: Pubmed, CINAHL, Scopus and PsycInfo. This review considered both qualitative and quantitative primary searches. We excluded articles belonging to grey literature, secondary literature and paediatric setting. Between September and November 2023, the review was carried out. RESULTS: A total of 569 documents were retrieved from the four databases. After the deduplication process, five articles were removed. The selection process based on titles and abstracts included 133 records. Ten studies were selected and analysed. The reviewers identified the following themes: device type and mobile applications, engagement, blood pressure control, health behaviours and hypertension knowledge. Self-management using digital technologies in the home is strongly linked to engagement, reduction and control of Blood Pressure, improved health practices and increased knowledge of hypertension. Healthcare interventions using IT platforms have had a significant impact on the health outcomes of patients diagnosed with hypertension. CONCLUSIONS: The review findings suggest the value of these technologies in improving patient engagement and, consequently, adherence to antihypertensive treatment and achieving blood pressure control rates, potentially reducing cardiovascular risk.
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Pressão Sanguínea , Conhecimentos, Atitudes e Prática em Saúde , Hipertensão , Participação do Paciente , Telemedicina , Humanos , Hipertensão/fisiopatologia , Hipertensão/diagnóstico , Hipertensão/terapia , Hipertensão/tratamento farmacológico , Pressão Sanguínea/efeitos dos fármacos , Aplicativos Móveis , Masculino , Feminino , Resultado do Tratamento , Adulto , Pessoa de Meia-Idade , Monitorização Ambulatorial da Pressão Arterial/instrumentação , Idoso , Anti-Hipertensivos/uso terapêuticoRESUMO
INTRODUCTION: New educational approaches are emerging to assist healthcare professionals in better personalizing patient's educational pathways. Specifically, "gamification" - the incorporation of game elements into non-game contexts - appears to be a novel and affordable approach. This scoping review aims to explore and map the literature that evaluates the efficacy of gamification in healthcare contexts. METHODS: A scoping review of reviews was conducted in MEDLINE, CINAHL, and PsycINFO using the JBI Manual for Evidence Synthesis guidelines and the PRISMA ScR checklist. RESULTS: A total of four systematic reviews and four meta-analyses were included. It appears that gamification, when used in conjunction with other conventional educational tools, improves physical activity, facilitates better self-management of type 2 diabetes, improves cognitive functions, and improves the quality of life, particularly among specific groups like the elderly. DISCUSSIONS: Gamification is an innovative educational approach that could be useful in patient's educational pathways. However, it seems that gamification is effective only in particular subgroups, and therefore the generalization of the results should also be assessed with caution due to the high risk of bias in the included studies and the small sample sizes considered. CONCLUSION: More randomized controlled trials and meta-analysis studies should be conducted to better understand the role and efficacy of gamification in patient education.
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Diabetes Mellitus Tipo 2 , Educação de Pacientes como Assunto , Qualidade de Vida , Humanos , Educação de Pacientes como Assunto/métodos , Diabetes Mellitus Tipo 2/terapia , Revisões Sistemáticas como Assunto , Exercício Físico , Autogestão/métodos , Autogestão/educação , Autocuidado/métodos , Idoso , Cognição , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: Urinary incontinence (UI) has been identified as a World Health Organization health priority. In particular, urge UI (UUI) refers to urine leakage associated with a sudden and compelling desire to void urine. It affects quality of life more than other kinds of UI, but it is not always treated adequately. For these reasons, this study aimed to evaluate the effectiveness of conservative treatment practices to counteract UUI in women aged 40-65 years old. METHODS: This systematic review was conducted following the Joanna Briggs Institute (JBI) methodology. According to the protocol registered in PROSPERO, a systematic search was carried out in the CINAHL, Embase, PubMed, PsycInfo, Scopus and Web of Science databases up to October 2022, to find primary studies meeting the inclusion criteria. RESULTS: Fourteen studies were included. The scientific literature reported different strategies dealing with the problem of UUI, some purely physical, others physical and psycho-educational and others exclusively psychological. CONCLUSION: Conservative treatments are useful to aid the reduction in UUI episodes in middle-aged women. However, none of them can be considered more effective than others due to the impossibility of conducting meta-analytical analyses. Further studies comparing the effectiveness of conservative treatments for UUI are needed.
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While for a long-time emotional reaction and moral distress, have been primarily investigated for the possible outcomes of the nursing decision-making process rather than in terms of their role as antecedents of the final decision taken. The primary study's aim is to explore how inpatient nurses' decision-making takes place in different care settings, with a special focus on the role played by emotions during decision-making. The secondary aim is to explore the subjective experience of hospital nurses in relation to successful and unsuccessful decision-making situations. Multicentre qualitative study, consisting of three phases with different designs: participatory study, grounded theory study, and phenomenological study. Participants will be nurses and may be doctors with various levels of professional experience working in hospital, outpatient, or ward settings. Participants will be recruited through different sampling (purposive and convenience). Data will be collected through focus groups and in-depth interviews with nurses working in different hospital care settings. The researchers expect to find themes that will contribute to a better understanding of the role of emotions in decision-making. The results of this study have the potential of providing important implications to support nurses in the recognition and management of their emotions during the decision-making process.
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BACKGROUND: The best exercise program for individuals with effort intolerance or hypoxia at rest and/or during exercise post-COVID-19 treatment who have already had in-hospital rehabilitation remains unknown. OBJECTIVE: We evaluated the efficacy of a home-based rehabilitation exercise program intervention that included teleconsultations with a specialist nurse. METHODS: This was a multicenter randomized controlled trial for individuals who had been diagnosed with, and treated for, COVID-19. Despite inpatient rehabilitation they still had effort intolerance; this was defined as being a) only able to walk <70 % of the predicted distance during the six-minute walking test (6MWT) and/or b) oxygen desaturation all day long/during effort. The primary outcome was effort tolerance, as evaluated by the 6MWT. Secondary outcomes were dyspnea, fatigue, spirometry, respiratory muscle evaluations, and oxygenation. The Intervention group performed 4 weeks of a self-directed exercise program with bi-weekly physiotherapist video calls; the Control group participated in physical activity howsoever they wished. Exercises were divided into 4 intensity levels according to disability and oxygen desaturation. The program progressively increased from low (walking, free-body exercise, sit-to-stand, and balance exercises) to high (speed walking with a pedometer, cycle ergometer, and strengthening exercises). RESULTS: We included 79 participants: 40 in the Intervention and 39 in the Control group. Mean (SD) age was 67.1 (10.3) years; 72 % (n = 57) were male. No intergroup differences in effort tolerance were found [Intervention 77.6 (75.4)m vs Control 49.5 (73.3)m (p = 0.109)]. Participants with 6MWT distance results < lower limit of normality values showed best improvements in mean (SD) effort tolerance: Intervention, 120.1 (75.8)m vs Control, 59.1 (75.6)m (p = 0.035). After 2 months, mean (SD) 6MWT distances in the 2 groups were similar: Intervention, 475.9 (82.4)m vs Control, 469.2 (118.9)m (p = 0.807). CONCLUSIONS: In individuals with residual disability post-COVID-19 and after inpatient rehabilitation, a home-based exercise program with teleconsultation significantly improves effort tolerance but only for people who had severe effort intolerance at baseline. DATABASE REGISTRATION: ClinicalTrials.gov number, NCT04821934.
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Tratamento Farmacológico da COVID-19 , COVID-19 , Humanos , Masculino , Idoso , Feminino , Terapia por Exercício/métodos , Caminhada/fisiologia , Hospitalização , OxigênioRESUMO
BACKGROUND: Education plays a pivotal role in the care of oncological patients, reducing health costs, hospital readmission, and disease relapses. Education can be supportive in achieving multiple outcomes, improving symptom control and quality of life. A new approach is emerging in patient education: gamification. Gamification was defined as the "use of game elements in non-game contexts", including the application of games in serious contexts. The aim of this review is to explore the use of gamification in the oncology setting. METHODS: A systematic scoping review was conducted in the MEDLINE, CINAHL, PsychINFO, Embase, Scopus, and Cochrane Library databases using the JBI guidelines. RESULTS: The 13 included reports were critically appraised by two reviewers independently. It seems that gamification could be effective both in prevention and cancer treatments. Gamification also seems to improve chemotherapy-induced nausea and vomiting management, quality of life, and reduced anxiety levels in different cancer groups. Moreover, gamification seems effective in improving self-care in cancer patients, regardless of gender, age, and ethnicity. CONCLUSIONS: Gamification improves patient engagement and biopsychosocial outcomes and could represent a valid approach to cancer patient education; however, it is not a substitute for healthcare professionals, who remain the leaders in the education process.
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INTRODUCTION: The number of Italian citizens unaware of their risk of cardiovascular disease it is still very high. AIM: This study aimed to translate and preliminarily validate a brief Italian version of the Perception of Risk of Heart Disease Scale (PRHDS). METHODS: PRHDS was culturally adapted to the Italian context. Then, the scale was administered to 772 healthy adults. By randomly dividing the sample into two subsamples, we tested the scale dimensionality through Exploratory Factor Analysis (EFA) followed by Confirmatory Factor Analysis (CFA). Finally, we evaluated internal consistency. RESULTS: Psychometric properties of the scale were appropriate. EFA and CFA evidenced a unidimensional structure of a brief version of the scale, composed of six items. Internal consistency was adequate. CONCLUSIONS: Italian version of the brief PRHDS is a promising self-report questionnaire to measure cardiovascular risk perception among Italian adults.
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Percepção , Adulto , Humanos , Psicometria/métodos , Reprodutibilidade dos Testes , Itália/epidemiologia , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Research shows that the longer nurses care for terminally ill patients, the greater they experience moral distress. The same applies to nursing students. This study aims to analyze episodes of moral distress experienced by nursing students during end-of-life care of onco-hematologic patients in hospital settings. METHODS: This study was conducted in the interpretative paradigm using a hermeneutic phenomenological approach and data were analyzed following the principles of the Interpretative Phenomenological Analysis. RESULTS: Seventeen participants were included in the study. The research team identified eight themes: causes of moral distress; factors that worsen or influence the experience of moral distress; feelings and emotions in morally distressing events; morally distressing events and consultation; strategies to cope with moral distress; recovering from morally distressing events; end-of-life accompaniment; internship clinical training, and nursing curriculum. CONCLUSIONS: Moral distress is often related to poor communication or lack of communication between health care professionals and patients or relatives and to the inability to satisfy patients' last needs and wants. Further studies are necessary to examine the quantitative dimension of moral distress in nursing students. Students frequently experience moral distress in the onco-hematological setting.
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BACKGROUND: Intensive care unit (ICU)-acquired weakness (ICUAW) is defined as a clinical syndrome of neuromuscular weakness, and a consequence of critical illness, unrelated to any other etiology. It is associated with difficult weaning from the ventilator, prolonged ICU stay, increased mortality, and other important long-term outcomes. Early mobilization is defined as any active exercise in which patients use their muscle strength actively or passively within the first 2 to 5 days of critical illness. Early mobilization can be safely initiated from the first day of admission to the ICU during mechanical ventilation. OBJECTIVES: The purpose of this review is to describe the effects of early mobilization on complications from ICUAW. METHOD: This was a literature review. Inclusion criteria were as follows: observational studies and randomized controlled trials conducted with adult patients (aged ≥18 years) admitted to the ICU were included. Studies selected were published in the last 11 years (2010-2021). RESULTS: Ten articles were included. Early mobilization reduces muscle atrophy, ventilation, length of hospital stay, and ventilator-associated pneumonia and improves patients' responses to inflammation and hyperglycemia. DISCUSSION: Early mobilization appears to have a significant impact on the prevention of ICUAW and appears to be safe and feasible. The results of this review could be useful for improving the provision of efficient and effective tailored care for ICU patients.
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Estado Terminal , Deambulação Precoce , Adulto , Humanos , Adolescente , Unidades de Terapia Intensiva , Cuidados Críticos/métodos , Respiração Artificial/efeitos adversos , Tempo de InternaçãoRESUMO
The combination of noradrenergic (reboxetine) plus antimuscarinic (oxybutynin) drugs (reb-oxy) reduced obstructive sleep apnea (OSA) severity but no data are available on its effects on cardiac autonomic modulation. We sought to evaluate the impact of 1-week reb-oxy treatment on cardiovascular autonomic control in OSA patients. OSA patients were randomized to a double-blind, crossover trial comparing 4 mg reboxetine plus 5 mg oxybutynin to a placebo for OSA treatment. Heart rate (HR) variability (HRV), ambulatory blood pressure (BP) monitoring (ABPM) over 24 h baseline and after treatment were performed. Baroreflex sensitivity was tested over beat-to-beat BP recordings. 16 subjects with (median [interquartile range]) age 57 [51-61] years and body mass index 30 [26-36]kg/m2 completed the study. The median nocturnal HR was 65 [60-69] bpm at baseline and increased to 69 [64-77] bpm on reb-oxy vs 66 [59-70] bpm on placebo (p = 0.02). The mean 24 h HR from ABPM was not different among treatment groups. Reb-oxy administration was not associated with any modification in HRV or BP. Reb-oxy increased the baroreflex sensitivity and did not induce orthostatic hypotension. In conclusion, administration of reb-oxy did not induce clinically relevant sympathetic overactivity over 1-week and, together with a reduction in OSA severity, it improved the baroreflex function.
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Monitorização Ambulatorial da Pressão Arterial , Apneia Obstrutiva do Sono , Humanos , Pessoa de Meia-Idade , Reboxetina/uso terapêutico , Sistema Nervoso Autônomo , Frequência Cardíaca/fisiologiaRESUMO
INTRODUCTION: Prevention of cardiovascular disease (CVD) is of key importance in reducing morbidity, disability and mortality worldwide. Observational studies suggest that digital health interventions can be an effective strategy to reduce cardiovascular (CV) risk. However, evidence from large randomised clinical trials is lacking. METHODS AND ANALYSIS: The CV-PREVITAL study is a multicentre, prospective, randomised, controlled, open-label interventional trial designed to compare the effectiveness of an educational and motivational mobile health (mHealth) intervention versus usual care in reducing CV risk. The intervention aims at improving diet, physical activity, sleep quality, psycho-behavioural aspects, as well as promoting smoking cessation and adherence to pharmacological treatment for CV risk factors. The trial aims to enrol approximately 80 000 subjects without overt CVDs referring to general practitioners' offices, community pharmacies or clinics of Scientific Institute for Research, Hospitalization and Health Care (Italian acronym IRCCS) affiliated with the Italian Cardiology Network. All participants are evaluated at baseline and after 12 months to assess the effectiveness of the intervention on short-term endpoints, namely improvement in CV risk score and reduction of major CV risk factors. Beyond the funded life of the study, a long-term (7 years) follow-up is also planned to assess the effectiveness of the intervention on the incidence of major adverse CV events. A series of ancillary studies designed to evaluate the effect of the mHealth intervention on additional risk biomarkers are also performed. ETHICS AND DISSEMINATION: This study received ethics approval from the ethics committee of the coordinating centre (Monzino Cardiology Center; R1256/20-CCM 1319) and from all other relevant IRBs and ethics committees. Findings are disseminated through scientific meetings and peer-reviewed journals and via social media. Partners are informed about the study's course and findings through regular meetings. TRIAL REGISTRATION NUMBER: NCT05339841.
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Doenças Cardiovasculares , Humanos , Estudos Prospectivos , Doenças Cardiovasculares/prevenção & controle , Dieta , Exercício FísicoRESUMO
OBJECTIVE: To summarise the available clinical evidence on the efficacy and safety of osteopathic manipulative treatment (OMT) for different conditions. DESIGN: Overview of systematic reviews (SRs) and meta-analyses (MAs). PROSPERO CRD42020170983. DATA SOURCES: An electronic search was performed using seven databases: PubMed, EMBASE, CINAHL, Scopus, JBI, Prospero and Cochrane Library, from their inception until November 2021. ELIGIBILITY CRITERIA FOR SELECTING STUDIES: SRs and MAs of randomised controlled trials evaluating the efficacy and safety of OMT for any condition were included. DATA EXTRACTION AND SYNTHESIS: The data were independently extracted by two authors. The AMSTAR-2 tool was used to assess the methodological quality of the SRs and MAs. The overview was conducted and reported according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. RESULTS: The literature search revealed nine SRs or MAs conducted between 2013 and 2020 with 55 primary trials involving 3740 participants. The SRs reported a wide range of conditions including acute and chronic non-specific low back pain (NSLBP, four SRs), chronic non-specific neck pain (CNSNP, one SR), chronic non-cancer pain (CNCP, one SR), paediatric (one SR), neurological (primary headache, one SR) and irritable bowel syndrome (IBS, one SR). Although with a different effect size and quality of evidence, MAs reported that OMT is more effective than comparators in reducing pain and improving functional status in acute/chronic NSLBP, CNSNP and CNCP. Due to small sample size, presence of conflicting results and high heterogeneity, questionable evidence existed on OMT efficacy for paediatric conditions, primary headache and IBS.No adverse events were reported in most SRs. According to AMSTAR-2, the methodological quality of the included SRs was rated low or critically low. CONCLUSION: Based on the currently available SRs and MAs, promising evidence suggests the possible effectiveness of OMT for musculoskeletal disorders. Limited and inconclusive evidence occurs for paediatric conditions, primary headache and IBS. Further well-conducted SRs and MAs are needed to confirm and extend the efficacy and safety of OMT.