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BACKGROUND: Being the most common type of arrhythmia, atrial fibrillation (AF) is progressively increasing with an annual rate of 5 million new cases. Recent guidelines highlight the importance of using collaborative multidisciplinary teams in order to improve outcomes during management of patients with AF. A nurse-led program including a nurse-directed education, counselling and intervention has shown to improve patients' outcomes in candidates with AF. In this analysis, we aimed to systematically compare the clinical outcomes observed in patients with AF who were assigned to a nurse-led interventional program versus a usual care group. METHODS: EMBASE, MEDLINE, Http://www. CLINICALTRIALS: gov , Web of Science; Google Scholar and Cochrane databases were the data sources. The clinical outcomes were considered as the endpoints in this study. This is a meta-analysis, and the statistical analysis was conducted by the RevMan software (version 5.4). Risk ratios (RR) with 95% confidence intervals (CI) were used to represent the data after statistical analysis. RESULTS: Six studies with a total number 2916 participants were included whereby 1434 participants were assigned to a nurse-led intervention and 1482 participants were assigned to the usual care group. Our results showed that participants with AF who were assigned to the nurse-led interventional group had a significantly lower risk of composite endpoints (RR: 0.82, 95% CI: 0.70-0.96; P = 0.01), heart failure (RR: 0.66, 95% CI: 0.47-0.92; P = 0.02), atrial fibrillation (RR: 0.77, 95% CI: 0.63-0.94; P = 0.01) and re-admission (RR: 0.78, 95% CI: 0.62-0.99; P = 0.04). However, the risks of all-cause mortality (RR: 0.86, 95% CI: 0.68-1.09; P = 0.21), cardiac death (RR: 0.67, 95% CI: 0.33-1.39; P = 0.28), myocardial infarction (RR: 0.70, 95% CI: 0.35-1.42; P = 0.33), stroke (RR: 0.75, 95% CI: 0.44-1.26; P = 0.28), all bleeding events (RR: 1.11, 95% CI: 0.81-1.53; P = 0.51) and major bleeding events (RR: 0.91, 95% CI: 0.56-1.49; P = 0.71) were not significantly different. CONCLUSIONS: The nurse-led interventional program significantly improved composite endpoints including heart failure and the recurrence of AF, resulting in a significantly lower admission rate compared to the usual care group. However, nurse-led interventional program did not affect mortality, stroke, myocardial infarction and bleeding events. Based on our current results, a nurse-led interventional programs apparently could be beneficial in patients with AF. Future larger trials would be able to confirm this hypothesis.
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Fibrilação Atrial , Insuficiência Cardíaca , Infarto do Miocárdio , Acidente Vascular Cerebral , Humanos , Fibrilação Atrial/diagnóstico , Fibrilação Atrial/terapia , Papel do Profissional de Enfermagem , AconselhamentoRESUMO
[Purpose] The prognostic factors for patients with acute stroke who received usual care (mobilization ≥48â h after admission) remain unclear. This study aimed to investigate the prognostic factors that predict functional outcomes using evaluations performed immediately after onset in patients with acute cerebral infarction who received usual care from admission until discharge. [Participants and Methods] Participants with acute cerebral infarction admitted to five acute care hospitals in Tokyo and Saitama, Japan and prescribed physical therapy were included. Participants information, functional evaluations, and progress were recorded during the first physical therapy session, mobilization, and discharge. Participants who received usual care were assigned to either the good- or poor-outcome group based on the Modified Rankin Scale at discharge. [Results] In total, 161 Participants receiving usual care (mobilization ≥48â h after admission) were included. Reinfarction and the First National Institutes of Health Stroke Scale score were identified as independent predictors of functional outcome at hospital discharge in participants who received usual care (median, 22.0 d). The cutoff NIHSS score was 4. [Conclusion] Our results provided evidence that the National Institutes of Health Stroke Scale score and reinfarction are useful predictors of functional outcomes in participants who received usual care.
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OBJECTIVE: The objectives of this systematic review were to describe the current dose and content of usual care upper limb motor intervention for inpatients following stroke and examine if context factors alter dose and content. DATA SOURCES: A systematic search (EMBASE, MEDLINE) was completed from January 2015 to February 2023 (PROSPERO CRD42021281986). METHODS: Studies were eligible if they reported non-protocolised usual care upper limb motor intervention dose data for stroke inpatients. Studies were rated using the Johanna Briggs Institute critical appraisal tool. Data were descriptively reported for dose dimensions of time (on task or, in therapy) and intensity (repetitions, repetition/minute), content (intervention type/mode), and context (e.g., severity strata). RESULTS: Eight studies were included from four countries, largely reflecting inpatient rehabilitation. Time in therapy ranged from 23 to 121â min/day. Time on task ranged from 8 to 44â min/day. Repetitions ranged from 36 to 57/session, and 15 to 282/day. Time on task was lowest in the stratum of people with severe upper limb impairment (8â min/day), the upper limit for this stratum was 41.5â min/day. There was minimal reporting of usual care content across all studies. CONCLUSION: Upper limb motor intervention dose appears to be increasing in usual care compared to prior reports (e.g., average 21â min/day and 23 to 32 repetitions/session). Context variability suggests that doses are lowest in the stratum of patients with a severely impaired upper limb. Consistent reporting of the multiple dimensions of dose and content is necessary to better understand usual care offered during inpatient rehabilitation.
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Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral , Humanos , Reabilitação do Acidente Vascular Cerebral/métodos , Acidente Vascular Cerebral/complicações , Acidente Vascular Cerebral/diagnóstico , Extremidade Superior , Atividades Cotidianas , Pacientes InternadosRESUMO
BACKGROUND: Healthcare provision remains challenging leading to a focus on health service redesign including the development of nurse-led clinics. While there is a belief that nurse-led services positively impact on healthcare delivery, it is necessary to inform development through examination of the evidence. METHODS: A search was conducted of Cumulative Index of Nursing and Allied Health Literature, MEDLINE, EMBASE, Scopus and the Cochrane Library for systematic reviews evaluating the effectiveness of nurse-led clinics when compared with usual care published between 2015 and 2020. Outcomes of interest were clinical outcomes, patient satisfaction and patient access to health care. Study quality was appraised using the AMSTAR 2 tool (A MeaSurement tool to Assess Systematic Reviews). A narrative analysis was conducted. RESULTS: From 681 identified studies, nine were included, with reporting quality rated from very low to high quality. Patient clinical outcomes were reported as equal to or better than usual care across all studies included. There was evidence of high levels of patient satisfaction with nurse-led clinics across the included systematic reviews. While access to health care was the least reported variable, there were reports that access to health care increased or patient reliance on other healthcare providers reduced due to nurse-led clinics. CONCLUSIONS: Despite the heterogeneous nature of the systematic reviews, along with some quality issues in reporting, there was evidence that nurse-led services provided comparable or superior care to usual care with high levels of patient satisfaction. There was a lack of reporting on the impact of nurse-led clinics on patient access to health care; further research is required on this area. Health service managers should consider nurse-led clinics an effective innovation in health service provision.
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Enfermeiras e Enfermeiros , Padrões de Prática em Enfermagem , Humanos , Revisões Sistemáticas como AssuntoRESUMO
OBJECTIVE: To compare the description of interventions defined as "usual care" in control groups with those provided in experimental groups in physiotherapy randomized clinical trials for multiple sclerosis. METHODS: Two independent reviewers conducted a literature search and study selection from five databases from their inception to February 2021. Randomized clinical trials aimed to physiotherapy multiple sclerosis treatment and providing "usual care" in the control group were included. Intervention reporting was assessed using the TIDieR checklist. Word and reference counts for each group were extracted. The methodological quality was assessed by the PEDro scale. RESULTS: Twenty-four articles were included. The TIDieR total scores, word, and reference count were statistically higher in the experimental group, when compared to the control group (p < 0.001). The TIDieR total score is not correlated with PEDro score, word, publication year, or reference counts. CONCLUSION: Control treatments identified as "usual care" are underdescribed when compared to experimental treatments, affecting the validity, generalizability, and interpretability of results.
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Esclerose Múltipla , Lista de Checagem , Grupos Controle , Humanos , Esclerose Múltipla/terapia , Modalidades de Fisioterapia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
PURPOSE: To determine the effect of community based Nurse-led support intervention in the reduction of HbA1c levels compared to usual care. DESIGN AND METHODS: A systematic search of four electronic databases was conducted until August 2021 including RCTs to check for a reduction in HbA1c levels in Nurse-led intervention arm. RESULTS: Twenty-one trials involving 4649 diabetic individuals were included in the review. The pooled mean difference in the reduction of HbA1c in the intervention group was found to be -0.421 (95% CI: -0.59 to -0.25). CONCLUSION AND EVIDENCE: Nurse-led educational intervention proved beneficial in the control of HbA1c among diabetic individuals.
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Diabetes Mellitus Tipo 2 , Diabetes Mellitus , Enfermeiras e Enfermeiros , Humanos , Hemoglobinas Glicadas/análise , Papel do Profissional de Enfermagem , AutocuidadoRESUMO
A foundational strategy to promote implementation of evidence-based interventions (EBIs) is providing EBI training to therapists. This study tested an online training system in which therapists practiced observational coding of mock video vignettes demonstrating family therapy techniques for adolescent behavior problems. The study compared therapists ratings to gold-standard scores to measure therapist reliability (consistency across vignettes) and accuracy (approximation to gold scores); tested whether reliability and accuracy improved during training; and tested therapist-level predictors of overall accuracy and change in accuracy over time. Participants were 48 therapists working in nine community behavioral health clinics. The 32-exercise training course provided online instruction (about 15 min/week) in 13 core family therapy techniques representing three modules: Family Engagement, Relational Orientation, Interactional Change. Therapist reliability in rating technique presence (i.e., technique recognition) remained moderate across training; reliability in rating extensiveness of technique delivery (i.e., technique judgment) improved sharply over time, from poor to good. Whereas therapists on average overestimated extensiveness for almost every technique, their tendency to give low-accuracy scores decreased. Therapist accuracy improved significantly over time only for Interactional Change techniques. Baseline digital literacy and submission of self-report checklists on use of the techniques in their own sessions predicted coding accuracy. Training therapists to be more reliable and accurate coders of EBI techniques can potentially yield benefits in increased EBI self-report acumen and EBI use in daily practice. However, training effects may need to improve from those reported here to avail meaningful impact on EBI implementation.Trial Registration: The parent clinical trial is registered at www.ClinicalTrials.gov , ID: NCT03342872 (registration date: 11.10.17).
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Pessoal Técnico de Saúde , Terapia Familiar , Adolescente , Humanos , Pais , Reprodutibilidade dos Testes , AutorrelatoRESUMO
Therapist-report measures of evidence-based interventions have enormous potential utility as quality indicators in routine care; yet, few such tools have shown strong psychometric properties. This study describes reliability and validity characteristics of a therapist-report measure of family therapy techniques for treating adolescent conduct and substance use problems: Inventory of Therapy Techniques for Core Elements of Family Therapy (ITT-CEFT). Study participants included 31 staff therapists treating 68 adolescent clients in eight community-based mental health and substance use clinics. Therapists submitted ITT-CEFT checklists and companion audio recordings for 189 sessions. The ITT-CEFT contains 13 techniques identified as core elements of three manualized family therapy models that are empirically supported for the target group. Therapists also reported on their use of three motivational interventions, and independent observers coded the submitted recordings. ITT-CEFT factor validity was shown via confirmatory factor analyses of the tool's theoretical structure. Derived modules were: Family Engagement (four items; Cronbach's α = .72); Relational Orientation (five items; α = .74); and Interactional Change (four items; α = .66). Concurrent validity analyses showed fair-to-excellent therapist reliability compared to observer ratings (ICCs range .64-.75); they showed moderate therapist accuracy compared to observer mean scores, reflecting a tendency to overestimate delivery of the techniques. Discriminant validity analyses showed tool differentiation from motivational interventions. Results offer provisional evidence for the feasibility of using the therapist-report ITT-CEFT to anchor quality procedures for family therapy interventions in real-world settings.Trial Registration: The parent clinical trial is registered at www.ClinicalTrials.gov , ID: NCT03342872 (registration date: 11.10.17).
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Comportamento do Adolescente , Terapia Familiar , Adolescente , Humanos , Psicometria , Indicadores de Qualidade em Assistência à Saúde , Reprodutibilidade dos Testes , AutorrelatoRESUMO
OBJECTIVE: To assess whether group cognitive behavioural therapy (GCBT) delivered by general practitioners reduces anxiety and depression and improves glycaemic levels in adults with type 2 diabetes mellitus. METHODS: We conducted a community-based cluster randomized controlled trial in adults with type 2 diabetes mellitus from 48 communities in China. Participants received either GCBT plus usual care (UC) or UC only. General practitioners were trained in GCBT before intervention in the intervention group. The primary outcome was glycated haemoglobin (HbA1c ) concentration. Outcome data were collected from all participants at baseline, 2 months, 6 months and 1 year. The secondary outcomes were depression (Patient Health Questionnaire-9; PHQ-9) and anxiety (General Anxiety Disorder questionnaire; GAD-7). RESULTS: The GCBT group showed greater improvement in GAD-7 and PHQ-9 scores, respectively, than the UC group after 2 months post-baseline (T = -6.46, p < 0.0001; T = -5.29, p < 0.001), 6 months (T = -4.58, p < 0.001; T = -4.37, p < 0.001) and 1 year post-intervention (T = -3.91, p < 0.001; T = -3.57, p < 0.001). There was no difference in HbA1c values between the GCBT and UC groups at 2 months while the values were lower in the GCBT group at 6 months and 1 year (T = -6.83, p < 0.001; T = -4.93, p < 0.001, respectively). Subgroup analysis indicated a long-term effect of GCBT only for mild and moderate anxiety and mild depression groups. Similarly, HbA1c values reduced only in the mild and moderate anxiety and the mild depression groups. CONCLUSIONS: General practitioners can deliver GCBT interventions. GCBT plus UC is superior to UC for reducing mild/moderate anxiety and depression, and improving glycaemic levels. TRIAL REGISTRATION: Chinese clinical trials registration (ChiCTR-IOP-16008045).
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Ansiedade/terapia , Terapia Cognitivo-Comportamental/métodos , Depressão/terapia , Diabetes Mellitus Tipo 2/metabolismo , Hemoglobinas Glicadas/metabolismo , Psicoterapia de Grupo/métodos , Estresse Psicológico/terapia , Idoso , Ansiedade/psicologia , China , Depressão/psicologia , Diabetes Mellitus Tipo 2/psicologia , Feminino , Clínicos Gerais , Humanos , Modelos Lineares , Masculino , Pessoa de Meia-Idade , Questionário de Saúde do Paciente , Estresse Psicológico/psicologia , Resultado do TratamentoRESUMO
BACKGROUND: Delirium is an acute condition that occurs in hospitalised patients and leads to poor patient outcomes that can last long term. Therefore, the importance of prevention is undeniable and adopting new models of care for at-risk patients should be prioritised. OBJECTIVES: This systematic review and meta-analysis will assess the effectiveness of different interventions designed to prevent or manage delirium in acutely unwell hospitalised patients. METHODS: MEDLINE, EMBASE, PsycINFO, OpenGrey, Web of Science and reference lists of journals were searched. Eligible studies reported on incidence or duration of delirium, used a validated delirium diagnostic tool and compared an intervention to either a control or another intervention group. Meta-analyses were conducted, and GRADEpro software was used to assess the certainty of evidence. This review is registered on PROSPERO. RESULTS: A total of 59 studies were included and 33 were eligible for meta-analysis. Delirium incidence was most significantly reduced by non-pharmacological multicomponent interventions compared with usual care, with pooled risk ratios of 0.57 (95% CI: 0.44 to 0.73, 10 randomised controlled trials) and 0.47 (95% CI: 0.35 to 0.64, six observational studies). Single-component interventions did not significantly reduce delirium incidence compared with usual care in seven randomised trials (risk ratio = 0.92, 95% CI: 0.81 to 1.04). The most effective single-component intervention in reducing delirium incidence was a hospital-at-home intervention (risk ratio = 0.29, 95% CI: 0.09 to 0.87). CONCLUSIONS: Non-pharmacological multicomponent interventions are effective in preventing delirium; however, the same cannot be said for other interventions because of uncertain results. There is some evidence that providing multicomponent interventions in patients' homes is more effective than in a hospital setting. Therefore, researching the benefits of hospital-at-home interventions in delirium prevention is recommended.
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Delírio , Cuidados Críticos , Delírio/prevenção & controle , Humanos , IncidênciaRESUMO
The descriptor 'usual care' refers to standard or routine care. Yet, no formal definition exists. The need to define what constitutes usual care arises in clinical research. Often one arm in a trial represents usual care in comparison with a novel intervention. Accordingly, usual care in genetic counseling research appears predominantly in randomized controlled trials. Recent standards for reporting genetic counseling research call for standardization, but do not address usual care. We (1) inventoried all seven studies in the Clinical Sequencing Evidence-Generating Consortium (CSER) about how genetic counseling was conceptualized, conducted, and whether a usual care arm was involved; (2) conducted a review of published randomized control trials in genetic counseling, comparing how researchers describe usual care groups; and (3) reviewed existing professionally endorsed definitions and practice descriptions of genetic counseling. We found wide variation in the content and delivery of usual care. Descriptions frequently detailed the content of usual care, most often noting assessment of genetic risk factors, collecting family histories, and offering testing. A minority included addressing psychological concerns or the risks versus benefits of testing. Descriptions of how care was delivered were vague except for mode and type of clinician, which varied. This significant variation, beyond differences expected among subspecialties, reduces the validity and generalizability of genetic counseling research. Ideally, research reflects clinical practice so that evidence generated can be used to improve clinical outcomes. To address this objective, we propose a definition of usual care in genetic counseling research that merges common elements from the National Society of Genetic Counselors' practice definition, the Reciprocal Engagement Model, and the Accreditation Council for Genetic Counselors' practice-based competencies. Promoting consistent execution of usual care in the design of genetic counseling trials can lead to more consistency in representing clinical care and facilitate the generation of evidence to improve it.
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Aconselhamento , Aconselhamento Genético , Acreditação , HumanosRESUMO
BACKGROUND: Nurse-led integrated care is expected to improve outcome of patients with atrial fibrillation compared with usual-care provided by a medical specialist. METHODS AND RESULTS: We randomized 1375 patients with atrial fibrillation (64 ± 10 years, 44% women, 57% had CHA2DS2-VASc ≥ 2) to receive nurse-led care or usual-care. Nurse-led care was provided by specialized nurses using a decision-support tool, in consultation with the cardiologist. The primary endpoint was a composite of cardiovascular death and cardiovascular hospital admissions. Of 671 nurse-led care patients, 543 (81%) received anticoagulation in full accordance with the guidelines against 559 of 683 (82%) usual-care patients. The cumulative adherence to guidelines-based recommendations was 61% under nurse-led care and 26% under usual-care. Over 37 months of follow-up, the primary endpoint occurred in 164 of 671 patients (9.7% per year) under nurse-led care and in 192 of 683 patients (11.6% per year) under usual-care [hazard ratio (HR) 0.85, 95% confidence interval (CI) 0.69 to 1.04, P = 0.12]. There were 124 vs. 161 hospitalizations for arrhythmia events (7.0% and 9.4% per year), and 14 vs. 22 for heart failure (0.7% and 1.1% per year), respectively. Results were not consistent in a pre-specified subgroup analysis by centre experience, with a HR of 0.52 (95% CI 0.37-to 0.71) in four experienced centres and of 1.24 (95% CI 0.94-1.63) in four less experienced centres (P for interaction <0.001). CONCLUSION: Our trial failed to show that nurse-led care was superior to usual-care. The data suggest that nurse-led care by an experienced team could be clinically beneficial (ClinicalTrials.gov NCT01740037). TRIAL REGISTRATION NUMBER: ClinicalTrials.gov (NCT01740037).
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Fibrilação Atrial , Insuficiência Cardíaca , Acidente Vascular Cerebral , Idoso , Anticoagulantes/uso terapêutico , Fibrilação Atrial/terapia , Feminino , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Papel do Profissional de Enfermagem , Modelos de Riscos ProporcionaisRESUMO
The positive psychology literature suggests focusing on strengths in mental health treatment improves well-being, reduces symptomology, and is linked to positive outcomes. However, there is little research on the use of strengths in treatment and their association with outcomes in youth clinical populations. The present study used multi-level modeling to examine the association between the proportional targeting of strengths and treatment outcomes for 1,841 youth ages 3-19 receiving intensive in-home services through a public mental health system. A greater percentage of targets endorsed during treatment that were strength-focused was associated with increased likelihood of successful treatment discharge, even after accounting for other predictors, including episode length, youth age, and level of impairment at treatment start. Specifically, as the percentage of strengths targeted increased from 46 to 64% of total targets endorsed, the odds of successful discharge increased by 21%. Such practice-based findings derived from aggregated data regarding services to multiethnic low-income families extend the strength-based intervention literature to include youth with significant life challenges. Study findings point to the need to develop structured interventions suitable for examination via clinical efficacy and effectiveness trials. Clinical practice, dissemination, implementation, and future research implications are discussed.
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Saúde Mental , Alta do Paciente , Adolescente , Adulto , Criança , Pré-Escolar , Humanos , Psicoterapia , Resultado do Tratamento , Adulto JovemRESUMO
Disruptive behavior problems develop along multiple causal pathways and are associated with a wide variety of co-occurring problems, including mood disorders. In usual care, effective treatment practices for youth disruptive behavior might differ from what the efficacy research suggests, given treatment setting and population demographic differences. The current study examined whether practices derived from the evidence base for disruptive behavior and/or depressed mood predicted progress on disruptive behavior problems in an adolescent usual care sample. Monthly clinical data, including therapeutic practices, treatment targets, and progress on selected treatment targets, for 1210 youth ages 13-17 who received intensive in-home services and were treated for disruptive behavior problems were examined utilizing multilevel modeling techniques. Practices derived from the evidence base for only depressed mood and practices derived from both disruptive behavior and depressed mood literatures predicted disruptive behavior progress, while practices derived from only the disruptive behavior evidence-based literature did not. All five practice elements exclusive to depressed mood treatment predicted positive disruptive behavior progress, while two of eleven disruptive behavior practices and four of seven practices derived from both problem areas predicted positive progress. Findings held when other predictors were included as covariates, including youth age and functional impairment. Although directionality remains unclear and further research is vital, usual care settings might present barriers to disruptive behavior treatment as prescribed by the evidence base, and youth-focused treatments based on depressed mood treatments merit further examination as a potentially promising route to effective treatment in such settings.
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Serviços Comunitários de Saúde Mental , Comportamento Problema , Adolescente , Depressão/terapia , Humanos , Saúde Mental , Transtornos do HumorRESUMO
BACKGROUND: Mixed dyslipidemia [elevated non-high-density lipoprotein cholesterol (non-HDL-C) and triglycerides (TGs), and decreased HDL-C] is common in type 2 diabetes mellitus (T2DM) and is associated with increased cardiovascular risk. Non-HDL-C and apolipoprotein B (ApoB) are the preferred therapeutic targets for mixed dyslipidemia. Alirocumab is a monoclonal antibody to proprotein convertase subtilisin/kexin type 9 (PCSK9) that effectively reduces low-density lipoprotein cholesterol (LDL-C), non-HDL-C, ApoB, and lipoprotein(a) (Lp[a]), and is well-tolerated in individuals with T2DM. METHODS: The previously reported open-label ODYSSEY DM-DYSLIPIDEMIA trial data demonstrated the effects of alirocumab on individuals with non-HDL-C ≥ 100 mg/dL and TGs ≥ 150 and < 500 mg/dL receiving stable maximally tolerated statin (n = 413). This post hoc subgroup analysis of the primary trial investigated the effects of alirocumab [75 mg every 2 weeks (Q2W) with possible increase to 150 mg Q2W at Week 12] versus usual care [ezetimibe, fenofibrate, or no additional lipid-lowering therapy (LLT)] on non-HDL-C and other lipids in individuals with T2DM and baseline TGs ≥ 200 mg/dL and HDL-C < 40 mg/dL (men) or < 50 mg/dL (women). RESULTS: Alirocumab significantly reduced non-HDL-C [LS mean difference (standard error (SE)), - 35.0% (3.9)], ApoB [LS mean difference (SE), - 34.7% (3.6)], LDL-C [LS mean difference (SE), - 47.3% (5.2)], LDL particle number [LS mean difference (SE), - 40.8% (4.1)], and Lp(a) [LS mean difference (SE), - 29.9% (5.4)] versus usual care from baseline to Week 24 (all P < 0.0001). Results were similar for alirocumab versus usual care. TG reductions were similar between alirocumab and usual care (no significant difference), but greater with fenofibrate versus alirocumab (P = 0.3371). Overall, alirocumab significantly increased HDL-C versus usual care [LS mean difference (SE), 7.9% (3.6); P < 0.05], although differences with alirocumab versus ezetimibe or fenofibrate were non-significant. Most individuals receiving alirocumab achieved ApoB < 80 mg/dL (67.9%) and non-HDL-C < 100 mg/dL (60.9%). Adverse event frequency was similar between alirocumab (67.2%) and usual care (70.7%). Additionally, no clinically relevant effect of alirocumab on change in glycemic parameters or use of antihyperglycemic agents was observed. CONCLUSIONS: Alirocumab is an effective therapeutic option for individuals with T2DM, TGs ≥ 200 mg/dL, and HDL-C < 40 mg/dL (men) or < 50 mg/dL (women). Atherogenic lipid (ApoB and non-HDL) reductions were greater with alirocumab than ezetimibe, fenofibrate, or no LLT. Consistent with previous studies, alirocumab was generally well tolerated. Trial registration Clinicaltrials.gov, NCT02642159. Registered December 24, 2015, https://clinicaltrials.gov/ct2/show/NCT02642159.
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Anticorpos Monoclonais Humanizados/uso terapêutico , Anticolesterolemiantes/uso terapêutico , HDL-Colesterol/sangue , Diabetes Mellitus Tipo 2/tratamento farmacológico , Dislipidemias/tratamento farmacológico , Inibidores de PCSK9 , Inibidores de Proteases/uso terapêutico , Triglicerídeos/sangue , Idoso , Anticorpos Monoclonais Humanizados/efeitos adversos , Anticolesterolemiantes/efeitos adversos , Biomarcadores/sangue , Diabetes Mellitus Tipo 2/sangue , Diabetes Mellitus Tipo 2/diagnóstico , Dislipidemias/sangue , Dislipidemias/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Inibidores de Proteases/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
BACKGROUND: Evaluations of complex interventions compared to usual care provided in palliative care are increasing. Not describing usual care may affect the interpretation of an intervention's effectiveness, yet how it can be described remains unclear. AIM: To demonstrate the feasibility of using multi-methods to describe usual care provided in randomised controlled trials (RCTs) of complex interventions, shown within a feasibility cluster RCT. DESIGN: Multi-method approach comprising usual care questionnaires, baseline case note review and focus groups with ward staff completed at study end. Thematic analysis of qualitative data, descriptive statistics of quantitative data, followed by methodological triangulation to appraise approach in relation to study aim. SETTING/PARTICIPANTS: Four general medical wards chosen from UK hospitals. Purposive sampling of healthcare professionals for usual care questionnaires, and focus groups. Review of 20 patients' notes from each ward who died during admission or within 100 days of discharge. RESULTS: Twenty-three usual care questionnaires at baseline, two focus groups comprising 20 healthcare professionals and 80 case note reviews. Triangulation of findings resulted in understanding the usual care provided to the targeted population in terms of context, structures, processes and outcomes for patients, families and healthcare professionals. Usual care was described, highlighting (1) similarities and embedded practices, (2) heterogeneity and (3) subtle changes in care during the trial within and across sites. CONCLUSIONS: We provide a feasible approach to defining usual care that can be practically adopted in different settings. Understanding usual care enhances the reliability of tested complex interventions, and informs research and policy priorities.
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Cuidados Paliativos , Ensaios Clínicos Controlados Aleatórios como Assunto , Projetos de Pesquisa , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Grupos Focais , Hospitalização , Humanos , Masculino , Pessoa de Meia-Idade , Inquéritos e QuestionáriosRESUMO
BACKGROUND: Little is known about treatment provided to people living in nursing care facilities (NCFs) after hospital admission for hip fracture. In addition, there are no clinical guidelines for rehabilitation and recovery following hip fracture for nursing home residents. METHODS: As part of a randomised trial (SACRED trial), which investigated the efficacy of a four week in-reach rehabilitation program, data were collected which described routine care for 240 people living in 76 nursing care facilities in South Australia who fractured their hips. The in-reach rehabilitation provided to 119 intervention participants is described, including intensity, type and methods used to encourage participation in rehabilitation. Adverse events that occurred, in particular falls, are also reported. RESULTS: NCF records indicated that, over the four weeks following discharge from hospital after hip fracture, 76% of patients receiving usual care had a consultation with their general practitioner. Physiotherapy was provided to 79% of patients in usual care (median of 1.96 h over the 4 weeks, which is less than 30 min each week of physiotherapy). In-reach rehabilitation was provided by the hospital team for 13 h over the 4 weeks with almost full attendance at physiotherapy sessions (median of 1 missed session, range 0-7 with a median of 14 physiotherapy sessions attended by participants, range 1-18). Experienced therapists provided a flexible approach to the rehabilitation to account for patients' dementia and associated neuropsychiatric symptoms while providing dietetic support, mobility training and education to nursing home staff. The number of falls experienced by those in the intervention group was higher compared to those in usual care (Relative Risk 1.38 (95%CI 1.04-1.84, p = 0.03). CONCLUSIONS: Rehabilitation can be provided to people living in NCFs following hip fracture, even when they have moderate to severe dementia but the model needs to be flexible. Provision of rehabilitation may increase the rate of falls in this population. Further studies are required to establish the feasibility of the intervention in other long term care settings. (327 words). TRIAL REGISTRATION: ACTRN12612000112864 registered on the Australian and New Zealand Clinical Trials Registry (ANZCTR).
Assuntos
Terapia por Exercício/métodos , Fraturas do Quadril/reabilitação , Acidentes por Quedas/estatística & dados numéricos , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Artroplastia de Quadril/reabilitação , Austrália/epidemiologia , Fraturas do Quadril/epidemiologia , Fraturas do Quadril/cirurgia , Fraturas do Quadril/terapia , Humanos , Nova Zelândia , Casas de Saúde , Qualidade de VidaRESUMO
PURPOSE: Within psycho-oncology clinical trials, usual care (UC) represents a common and important control condition. Yet recent shifts in oncology, coupled with insufficient description of such conditions, threaten to render UC increasingly difficult to define and interpret. This paper offers evidence of these shifts and recommendations for addressing them. METHODS: The broader literature on usual care as a control condition in psychosocial/behavioral intervention trials was assessed, and usual care-controlled trials in psycho-oncology were selectively reviewed, toward to goal of conceptual synthesis. RESULTS: We offer evidence that (1) UC control conditions are often insufficiently defined and assessed; and (2) the context of supportive care in oncology has shifted in a manner that contributes to this problem, with implications for interpreting and comparing findings across clinical trials. Three converging findings support these conclusions. First, the scientific literature increasingly documents the diversity in how "usual care" conditions are defined across psychosocial and behavioral trials, with important considerations for trial interpretation. Second, evidence suggests that the availability of psychosocial oncology care has increased over the past few decades. The increasing availability and variety of psychosocial care introduces potential confounds for UC conditions. Third, mental health care trends in the general population affect the supportive interventions available to oncology patients in UC conditions today versus in the past. CONCLUSIONS: Shifts in psychosocial oncology and broader mental health care underscore the importance of carefully defining and assessing UC in psycho-oncology trials. Recommendations are offered for improving the design, evaluation, and interpretation of UC conditions, toward the ultimate goal of improving the quality of the evidence in psycho-oncology.
Assuntos
Neoplasias/psicologia , Neoplasias/terapia , Psico-Oncologia/métodos , Terapia Comportamental/métodos , Humanos , Psico-Oncologia/normas , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
BACKGROUND: The behavioral health service provider population is highly heterogeneous. However, it is rarely treated as such within evidence-based practice implementation efforts. This study aimed to evaluate, as a proof of concept, the utility of latent profile analysis to identify distinct profiles of clinician practices in a large sample of youth-serving community mental health clinicians. This study also aimed to identify predictors of profile membership to inform implementation efforts. METHODS: Participants were 484 practicing clinicians (79.4% female, 45.7% White, M age = 37.1 years). As part of a larger survey, clinicians reported on their use of cognitive, behavioral, family, and psychodynamic treatment techniques with a representative client on their caseload. Latent profile analysis was used to determine the presence of clinician practice profiles. Multilevel multinomial logistic regressions examined predictors of profile membership. RESULTS: Latent profile analysis indicated a 4-profile solution best fit the data, with clinicians who: 1) used generally low levels of all examined techniques and preferred cognitive techniques (Low Eclectics, 16%), 2) delivered moderate levels of all techniques (Moderate Eclectics, 53%), 3) demonstrated preference for use of family techniques (Family Preferred, 11%), and 4) used high levels of all techniques (Super Users, 20%). Clinician discipline (e.g., social work), education, and years of experience predicted profile membership. CONCLUSIONS: Findings from this proof of concept study underscore the utility of latent profile analysis to characterize the complex and heterogeneous makeup of community mental health. Results extend prior work highlighting the eclectic nature of community mental health practice. Predictor analyses underscore the important influence of clinician background characteristics on practice use.
Assuntos
Serviços Comunitários de Saúde Mental/métodos , Prática Clínica Baseada em Evidências/métodos , Análise de Classes Latentes , Saúde Mental , Transtornos do Neurodesenvolvimento/terapia , Adolescente , Adulto , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Transtornos do Neurodesenvolvimento/epidemiologia , Transtornos do Neurodesenvolvimento/psicologia , Philadelphia/epidemiologiaRESUMO
Previous surveys indicate infrequent use of evidence-based treatment (EBT) manuals in usual care youth mental health, but the extent to which providers use core and common EBT strategies and what contextual factors impact EBT strategy implementation need further study. In a national, multidisciplinary survey of 1092 youth-serving providers, providers reported regular use of many EBT strategies. Provider learning theory orientation, more recent degree, more standardized and ongoing assessment use, more positive attitudes toward innovation and evidence, fewer low-income clients, and perceptions that their agency valued quality care and provided fewer training resources predicted more frequent EBT strategy use.