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1.
CJC Open ; 2(6): 577-584, 2020 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-33305218

RESUMO

Background: Physicians commonly judge whether a myocardial infarction (MI) is type 1 (thrombotic) vs type 2 (supply/demand mismatch) based on clinical information. Little is known about the accuracy of physicians' clinical judgement in this regard. We aimed to determine the accuracy of physicians' judgement in the classification of type 1 vs type 2 MI in perioperative and nonoperative settings. Methods: We performed an online survey using cases from the Optical Coherence Tomographic Imaging of Thrombus (OPTIMUS) Study, which investigated the prevalence of a culprit lesion thrombus based on intracoronary optical coherence tomography (OCT) in patients experiencing MI. Four MI cases, 2 perioperative and 2 nonoperative, were selected randomly, stratified by etiology. Physicians were provided with the patient's medical history, laboratory parameters, and electrocardiograms. Physicians did not have access to intracoronary OCT results. The primary outcome was the accuracy of physicians' judgement of MI etiology, measured as raw agreement between physicians and intracoronary OCT findings. Fleiss' kappa and Gwet's AC1 were calculated to correct for chance. Results: The response rate was 57% (308 of 536). Respondents were 62% male; median age was 45 years (standard deviation ± 11); 45% had been in practice for > 15 years. Respondents' overall accuracy for MI etiology was 60% (95% confidence interval [CI] 57%-63%), including 63% (95% CI 60%-68%) for nonoperative cases, and 56% (95% CI 52%-60%) for perioperative cases. Overall chance-corrected agreement was poor (kappa = 0.05), consistent across specialties and clinical scenarios. Conclusions: Physician accuracy in determining MI etiology based on clinical information is poor. Physicians should consider results from other testing, such as invasive coronary angiography, when determining MI etiology.

2.
Lancet Haematol ; 7(10): e746-e755, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32976752

RESUMO

BACKGROUND: Study-level meta-analyses provide high-certainty evidence that heparin reduces the risk of symptomatic venous thromboembolism for patients with cancer; however, whether the benefits and harms associated with heparin differ by cancer type is unclear. This individual participant data meta-analysis of randomised controlled trials examines the effect of heparin on survival, venous thromboembolism, and bleeding in patients with cancer in general and by type. METHODS: In this systematic review and meta-analysis we searched MEDLINE, Embase, and The Cochrane Library for randomised controlled trials comparing parenteral anticoagulants with placebo or standard care in ambulatory patients with solid tumours and no indication for anticoagulation published from the inception of each database to January 14, 2017, and updated it on May 14, 2020, without language restrictions. We calculated the effect of parenteral anticoagulant administration on all-cause mortality, venous thromboembolism occurrence, and bleeding related outcomes through multivariable hierarchical models with patient-level variables as fixed effects and a categorical trial variable as a random effect, adjusting for age, cancer type, and metastatic status. Interaction terms were tested to investigate effects in predefined subgroups. This study is registered with PROSPERO, CRD42013003526. FINDINGS: We obtained individual participant data from 14 of 20 eligible randomised controlled trials (8278 [79%] of 10 431 participants; 4139 included in the low-molecular-weight heparin group and 4139 in the control group). Meta-analysis showed an adjusted relative risk (RR) of mortality at 1 year of 0·99 (95% CI 0·93-1·06) and a hazard ratio of 1·01 (95% CI 0·96-1·07). The number of patients with venous thromboembolic events was 158 (4·0%) of 3958 with available data in the low-molecular-weight heparin group compared with 279 (7·1%) of 3957 in the control group. Major bleeding events occurred in 71 (1·7%) of 4139 patients in the control population and 88 (2·1%) in the low-molecular-weight heparin group, and minor bleeding events in 478 (12·1%) of 3945 patients with available data in the control group and 652 (16·6%) of 3937 patients in the low-molecular-weight heparin group. The adjusted RR was 0·58 (95% CI 0·47-0·71) for venous thromboembolism, 1·27 (0·92-1·74) for major bleeding, and 1·34 (1·19-1·51) for minor bleeding. Prespecified subgroup analysis of venous thromboembolism occurrence by cancer type identified the most certain benefit from heparin treatment in patients with lung cancer (RR 0·59 [95% CI 0·42-0·81]), which dominated the overall reduction in venous thromboembolism. Certainty of the evidence for the outcomes ranged from moderate to high. INTERPRETATION: Low-molecular-weight heparin reduces risk of venous thromboembolism without increasing risk of major bleeding compared with placebo or standard care in patients with solid tumours, but it does not improve survival. FUNDING: Canadian Institutes of Health Research.


Assuntos
Anticoagulantes/uso terapêutico , Heparina/uso terapêutico , Neoplasias/complicações , Tromboembolia Venosa/etiologia , Tromboembolia Venosa/prevenção & controle , Anticoagulantes/efeitos adversos , Hemorragia/induzido quimicamente , Heparina/efeitos adversos , Heparina de Baixo Peso Molecular/efeitos adversos , Heparina de Baixo Peso Molecular/uso terapêutico , Humanos , Análise de Sobrevida
3.
BMJ ; 370: m2980, 2020 07 30.
Artigo em Inglês | MEDLINE | ID: mdl-32732190

RESUMO

OBJECTIVE: To compare the effects of treatments for coronavirus disease 2019 (covid-19). DESIGN: Living systematic review and network meta-analysis. DATA SOURCES: US Centers for Disease Control and Prevention COVID-19 Research Articles Downloadable Database, which includes 25 electronic databases and six additional Chinese databases to 20 July 2020. STUDY SELECTION: Randomised clinical trials in which people with suspected, probable, or confirmed covid-19 were randomised to drug treatment or to standard care or placebo. Pairs of reviewers independently screened potentially eligible articles. METHODS: After duplicate data abstraction, a bayesian random effects network meta-analysis was conducted. Risk of bias of the included studies was assessed using a modification of the Cochrane risk of bias 2.0 tool, and the certainty of the evidence using the grading of recommendations assessment, development and evaluation (GRADE) approach. For each outcome, interventions were classified in groups from the most to the least beneficial or harmful following GRADE guidance. RESULTS: 23 randomised controlled trials were included in the analysis performed on 26 June 2020. The certainty of the evidence for most comparisons was very low because of risk of bias (lack of blinding) and serious imprecision. Glucocorticoids were the only intervention with evidence for a reduction in death compared with standard care (risk difference 37 fewer per 1000 patients, 95% credible interval 63 fewer to 11 fewer, moderate certainty) and mechanical ventilation (31 fewer per 1000 patients, 47 fewer to 9 fewer, moderate certainty). These estimates are based on direct evidence; network estimates for glucocorticoids compared with standard care were less precise because of network heterogeneity. Three drugs might reduce symptom duration compared with standard care: hydroxychloroquine (mean difference -4.5 days, low certainty), remdesivir (-2.6 days, moderate certainty), and lopinavir-ritonavir (-1.2 days, low certainty). Hydroxychloroquine might increase the risk of adverse events compared with the other interventions, and remdesivir probably does not substantially increase the risk of adverse effects leading to drug discontinuation. No other interventions included enough patients to meaningfully interpret adverse effects leading to drug discontinuation. CONCLUSION: Glucocorticoids probably reduce mortality and mechanical ventilation in patients with covid-19 compared with standard care. The effectiveness of most interventions is uncertain because most of the randomised controlled trials so far have been small and have important study limitations. SYSTEMATIC REVIEW REGISTRATION: This review was not registered. The protocol is included as a supplement. READERS' NOTE: This article is a living systematic review that will be updated to reflect emerging evidence. Updates may occur for up to two years from the date of original publication.


Assuntos
Antivirais/uso terapêutico , Betacoronavirus/isolamento & purificação , Infecções por Coronavirus/terapia , Pneumonia Viral/terapia , Respiração Artificial/estatística & dados numéricos , Monofosfato de Adenosina/análogos & derivados , Monofosfato de Adenosina/uso terapêutico , Alanina/análogos & derivados , Alanina/uso terapêutico , Betacoronavirus/patogenicidade , Centers for Disease Control and Prevention, U.S./estatística & dados numéricos , China/epidemiologia , Infecções por Coronavirus/diagnóstico , Infecções por Coronavirus/tratamento farmacológico , Infecções por Coronavirus/mortalidade , Infecções por Coronavirus/virologia , Bases de Dados Factuais/estatística & dados numéricos , Combinação de Medicamentos , Medicina Baseada em Evidências/métodos , Medicina Baseada em Evidências/estatística & dados numéricos , Glucocorticoides/uso terapêutico , Humanos , Hidroxicloroquina/uso terapêutico , Lopinavir/uso terapêutico , Metanálise em Rede , Pandemias , Pneumonia Viral/diagnóstico , Pneumonia Viral/mortalidade , Pneumonia Viral/virologia , Ensaios Clínicos Controlados Aleatórios como Assunto , Ritonavir/uso terapêutico , Índice de Gravidade de Doença , Padrão de Cuidado , Resultado do Tratamento , Estados Unidos/epidemiologia
4.
Pilot Feasibility Stud ; 6: 104, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32699643

RESUMO

Background: Surgical bleeding is associated with postoperative cardiovascular complications. The efficacy and safety of tranexamic acid (TXA) in noncardiac surgery are still uncertain. Statins may prevent perioperative cardiovascular complications. We conducted a pilot to assess the feasibility of a perioperative trial of TXA and rosuvastatin. Methods: Using a factorial design, we randomized patients at cardiovascular risk undergoing noncardiac surgery to intravenous TXA (1 g at the start and end of surgery) or placebo, and oral rosuvastatin (40 mg before and 20 mg daily for 30 days after surgery) or placebo. Feasibility outcomes included recruitment rates, follow-up, and compliance to interventions. Clinical outcomes were secondarily explored. Results: After 3 months, we changed the design to a partial factorial due to the difficult recruitment of statin-naive patients. Over 6 months, 100 patients were randomized in the TXA trial (49 TXA, 51 placebo), 34 in the rosuvastatin trial (18 rosuvastatin, 16 placebo). Ninety-two percent (95% CI 80-98) of TXA and 86% (95% CI 74-94) of TXA-placebo patients received the 2 study doses. Thirty-three percent (95% CI 13-59) of rosuvastatin patients and 37% (95% CI 15-65) of rosuvastatin-placebo patients discontinued the study drug. A major cardiovascular complication occurred at 30 days in 1 TXA and 6 TXA-placebo patients, and 1 rosuvastatin and no rosuvastatin-placebo patients. Conclusions: Our pilot study supports the feasibility of a perioperative TXA trial in noncardiac surgery. Feasibility of a perioperative rosuvastatin trial is uncertain because of a high prevalence of statin use in the target population and concerns about compliance. Trial registration: ClinicalTrials.govNCT02546648.

5.
J Clin Epidemiol ; 125: 100-107, 2020 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-32512185

RESUMO

Calculating the number needed to treat (NNT) has been widely used to help understand treatment effect results of randomized controlled trials (RCTs). Combined benefit and harm profiles from RCT results have to be taken into account to maximize benefits and minimize harms. Unfortunately, in the biomedical community, there is no easy and acceptable way to incorporate both benefit and harm information of treatments in a single summary statistic similar to an NNT. In this study, we propose a new metric, the "NNT for net effect" or NNTnet to present the combined benefit and harm effects of an intervention or therapy based on NNT-type information with the intention that it will advance decision-making for health professionals, researchers, and resource managers in real-world practice. Examples are provided to illustrate the calculation and application of the NNTnet in practice. An NNTnet is specifically applicable to the physicians and resource managers who interpret the data published in the literature to help with their decision-making and the researchers who present the trial data to the audiences in their studies and presentations, all of whom used to use NNT information to show and interpret beneficial and harmful effects separately.

6.
J Clin Epidemiol ; 126: 17-25, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-32531265

RESUMO

OBJECTIVES: This study aimed to review the degree of personalization of benefit and harm in the reporting of recent high-profile randomized controlled trials (RCTs) involving pharmacological interventions. STUDY DESIGN AND SETTING: This study is a systematic review of RCTs published between 2012 and 2017 with at least one intervention evaluating drug therapy and meeting the "high-profile" threshold in a premier academic literature abstraction service. Our primary outcome was the proportion of trials reporting subgroup analyses of a combined benefit-harm outcome. Secondary outcomes included the proportion of trials reporting subgroup analyses or clinical prediction guide for benefits or harms. We assessed the quality of the subgroup analyses using a modified version of previously published credibility criteria. RESULTS: Of 296 eligible RCTs, nine studies (3%) reported a combined benefit-harm endpoint. We found subgroup analyses of a combined benefit-harm endpoint in three studies (1%), a benefit endpoint in 167 studies (56.4%), and a harm endpoint in 18 studies (6.1%). The overall quality of the subgroup analyses was poor. Only one study reported a clinical prediction guide for an outcome. CONCLUSION: Despite great interest in the personalization of therapies, it is rarely reported in high-profile trials. Lack of rigorous and widely accepted methods may be the major barrier.

7.
BMC Med Res Methodol ; 20(1): 113, 2020 05 12.
Artigo em Inglês | MEDLINE | ID: mdl-32398016

RESUMO

BACKGROUND: Shifts in data sharing policy have increased researchers' access to individual participant data (IPD) from clinical studies. Simultaneously the number of IPD meta-analyses (IPDMAs) is increasing. However, rates of data retrieval have not improved. Our goal was to describe the challenges of retrieving IPD for an IPDMA and provide practical guidance on obtaining and managing datasets based on a review of the literature and practical examples and observations. METHODS: We systematically searched MEDLINE, Embase, and the Cochrane Library, until January 2019, to identify publications focused on strategies to obtain IPD. In addition, we searched pharmaceutical websites and contacted industry organizations for supplemental information pertaining to recent advances in industry policy and practice. Finally, we documented setbacks and solutions encountered while completing a comprehensive IPDMA and drew on previous experiences related to seeking and using IPD. RESULTS: Our scoping review identified 16 articles directly relevant for the conduct of IPDMAs. We present short descriptions of these articles alongside overviews of IPD sharing policies and procedures of pharmaceutical companies which display certification of Principles for Responsible Clinical Trial Data Sharing via Pharmaceutical Research and Manufacturers of America or European Federation of Pharmaceutical Industries and Associations websites. Advances in data sharing policy and practice affected the way in which data is requested, obtained, stored and analyzed. For our IPDMA it took 6.5 years to collect and analyze relevant IPD and navigate additional administrative barriers. Delays in obtaining data were largely due to challenges in communication with study sponsors, frequent changes in data sharing policies of study sponsors, and the requirement for a diverse skillset related to research, administrative, statistical and legal issues. CONCLUSIONS: Knowledge of current data sharing practices and platforms as well as anticipation of necessary tasks and potential obstacles may reduce time and resources required for obtaining and managing data for an IPDMA. Sufficient project funding and timeline flexibility are pre-requisites for successful collection and analysis of IPD. IPDMA researchers must acknowledge the additional and unexpected responsibility they are placing on corresponding study authors or data sharing administrators and should offer assistance in readying data for sharing.

8.
J Thromb Haemost ; 18(8): 1940-1951, 2020 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-32336010

RESUMO

BACKGROUND: Oncology guidelines suggest using the Khorana score to select ambulatory cancer patients receiving chemotherapy for primary venous thromboembolism (VTE) prevention, but its performance in different cancers remains uncertain. OBJECTIVE: To examine the performance of the Khorana score in assessing 6-month VTE risk, and the efficacy and safety of low-molecular-weight heparin (LMWH) among high-risk Khorana score patients. METHODS: This individual patient data meta-analysis evaluated (ultra)-LMWH in patients with solid cancer using data from seven randomized controlled trials. RESULTS: A total of 3293 patients from the control groups with an available Khorana score had lung (n = 1913; 58%), colorectal (n = 452; 14%), pancreatic (n = 264; 8%), gastric (n = 201; 6%), ovarian (n = 184; 56%), breast (n = 164; 5%), brain (n = 84; 3%), or bladder cancer (n = 31; 1%). The 6-month VTE incidence was 9.8% among high-risk Khorana score patients and 6.4% among low-to-intermediate-risk patients (odds ratio [OR], 1.6; 95% confidence interval [CI], 1.1-2.2). The dichotomous Khorana score performed differently in lung cancer patients (OR 1.1; 95% CI, 0.72-1.7) than in the group with other cancer types (OR 3.2; 95% CI, 1.8-5.6; Pinteraction  = .002). Among high-risk patients, LMWH decreased the risk of VTE by 64% compared with controls (OR 0.36; 95% CI, 0.22-0.58), without increasing the risk of major bleeding (OR 1.1; 95% CI, 0.59-2.1). CONCLUSION: The Khorana score was unable to stratify patients with lung cancer based on their VTE risk. Among those with other cancer types, a high-risk score was associated with a three-fold increased risk of VTE compared with a low-to-intermediate risk score. Thromboprophylaxis was effective and safe in patients with a high-risk Khorana score.

10.
Emerg Med J ; : 660-665, 2019 Nov 06.
Artigo em Inglês | MEDLINE | ID: mdl-31694858

RESUMO

OBJECTIVE: We investigated the association between the publication of the Consolidated Standards of Reporting Trials extension for abstracts (CONSORT-EA) and other variables of interest on the quality of reporting of abstracts of randomised controlled trials (RCTs) published in emergency medicine (EM) journals. METHODS: We performed a survey of the literature, comparing the quality of reporting before (2005-2007) with after (2014-2015) the publication of the dedicated CONSORT-EA in 2008. The quality of reporting was measured as the sum of items of the CONSORT-EA checklist reported in each abstract, ranging from 0 to 15. The main explanatory variable was the period of publication: pre-CONSORT-EA versus post-CONSORT-EA public. Other explanatory variables were journal's endorsement of the CONSORT statement, number of centres participating in the study, study's sample size, type of intervention, significance of results, source of funding and study setting. We analysed the data using generalised estimation equations, performing a univariate and a multivariable analysis. RESULTS: We retrieved 844 articles, and randomly selected 60 per period for review, after stratifying for journal. The mean (SD) number of items reported was 6.4 (1.9) in the period before and 6.9 (1.8) in the period after the publication of the CONSORT-EA, with an adjusted mean difference (aMD) of 0.47 (95% CI -0.13 to 1.06). Abstracts of trials of pharmacological interventions had a significantly larger mean number of reported items than those of trials of non-pharmacological interventions (aMD 1.59; 95% CI 0.94 to 2.24). CONCLUSIONS: The quality of reporting in abstracts of RCTs published in EM journals is low and was not significantly impacted by the publication of a dedicated CONSORT-EA.

11.
BMC Med ; 17(1): 193, 2019 10 29.
Artigo em Inglês | MEDLINE | ID: mdl-31660959

RESUMO

BACKGROUND: Age-related frailty is a multidimensional dynamic condition associated with adverse patient outcomes and high costs for health systems. Several interventions have been proposed to tackle frailty. This correspondence article describes the journey through the development of evidence- and consensus-based guidelines on interventions aimed at preventing, delaying or reversing frailty in the context of the FOCUS (Frailty Management Optimisation through EIP-AHA Commitments and Utilisation of Stakeholders Input) project (664367-FOCUS-HP-PJ-2014). The rationale, framework, processes and content of the guidelines are described. MAIN TEXT: The guidelines were framed into four questions - one general and three on specific groups of interventions - all including frailty as the primary outcome of interest. Quantitative and qualitative studies and reviews conducted in the context of the FOCUS project represented the evidence base. We followed the GRADE Evidence-to-Decision frameworks based on assessment of whether the problem is a priority, the magnitude of the desirable and undesirable effects, the certainty of the evidence, stakeholders' values, the balance between desirable and undesirable effects, the resource use, and other factors like acceptability and feasibility. Experts in the FOCUS consortium acted as panellists in the consensus process. Overall, we eventually recommended interventions intended to affect frailty as well as its course and related outcomes. Specifically, we recommended (1) physical activity programmes or nutritional interventions or a combination of both; (2) interventions based on tailored care and/or geriatric evaluation and management; and (3) interventions based on cognitive training (alone or in combination with exercise and nutritional supplementation). The panel did not support interventions based on hormone treatments or problem-solving therapy. However, all our recommendations were weak (provisional) due to the limited available evidence and based on heterogeneous studies of limited quality. Furthermore, they are conditional to the consideration of participant-, organisational- and contextual/cultural-related facilitators or barriers. There is insufficient evidence in favour of or against other types of interventions. CONCLUSIONS: We provided guidelines based on quantitative and qualitative evidence, adopting methodological standards, and integrating relevant stakeholders' inputs and perspectives. We identified the need for further studies of a higher methodological quality to explore interventions with the potential to affect frailty.


Assuntos
Fragilidade/prevenção & controle , Idoso , Idoso de 80 Anos ou mais , Exercício Físico , Fragilidade/dietoterapia , Avaliação Geriátrica , Humanos , Pesquisa Qualitativa
12.
J Med Internet Res ; 21(8): e13228, 2019 08 06.
Artigo em Inglês | MEDLINE | ID: mdl-31389341

RESUMO

BACKGROUND: In the last decade, the family system has changed significantly. Although in the past, older people used to live with their children, nowadays, they cannot always depend on assistance of their relatives. Many older people wish to remain as independent as possible while remaining in their homes, even when living alone. To do so, there are many tasks that they must perform to maintain their independence in everyday life, and above all, their well-being. Information and communications technology (ICT), particularly robotics and domotics, could play a pivotal role in aging, especially in contemporary society, where relatives are not always able to accurately and constantly assist the older person. OBJECTIVE: The aim of this study was to understand the needs, preferences, and views on ICT of some prefrail older people who live alone. In particular, we wanted to explore their attitude toward a hypothetical caregiver robot and the functions they would ask for. METHODS: We designed a qualitative study based on an interpretative phenomenological approach. A total of 50 potential participants were purposively recruited in a big town in Northern Italy and were administered the Fried scale (to assess the participants' frailty) and the Mini-Mental State Examination (to evaluate the older person's capacity to comprehend the interview questions). In total, 25 prefrail older people who lived alone participated in an individual semistructured interview, lasting approximately 45 min each. Overall, 3 researchers independently analyzed the interviews transcripts, identifying meaning units, which were later grouped in clustering of themes, and finally in emergent themes. Constant triangulation among researchers and their reflective attitude assured trustiness. RESULTS: From this study, it emerged that a number of interviewees who were currently using ICT (ie, smartphones) did not own a computer in the past, or did not receive higher education, or were not all young older people (aged 65-74 years). Furthermore, we found that among the older people who described their relationship with ICT as negative, many used it in everyday life. Referring to robotics, the interviewees appeared quite open-minded. In particular, robots were considered suitable for housekeeping, for monitoring older people's health and accidental falls, and for entertainment. CONCLUSIONS: Older people's use and attitudes toward ICT does not always seem to be related to previous experiences with technological devices, higher education, or lower age. Furthermore, many participants in this study were able to use ICT, even if they did not always acknowledge it. Moreover, many interviewees appeared to be open-minded toward technological devices, even toward robots. Therefore, proposing new advanced technology to a group of prefrail people, who are self-sufficient and can live alone at home, seems to be feasible.


Assuntos
Atitude Frente a Saúde , Comunicação , Idoso Fragilizado , Robótica , Idoso , Idoso de 80 Anos ou mais , Feminino , Serviços de Saúde para Idosos , Humanos , Entrevistas como Assunto , Itália , Masculino , Pesquisa Qualitativa
13.
Am J Med ; 132(8): e634-e647, 2019 08.
Artigo em Inglês | MEDLINE | ID: mdl-31075225

RESUMO

PURPOSE: This study was intended to determine whether a simulation-based education addressed to physicians was able to increase the proportion of hospitalized elderly with atrial fibrillation prescribed with oral anticoagulants (OACs) compared with the usual practice. METHODS: We conducted a cluster randomized trial (from April 2015 to September 2018) on 32 Italian internal medicine and geriatric wards randomized 1:1 to intervention or control arms. The physicians of wards randomized to intervention received a computer-based e-learning tool with clinical scenarios (Dr Sim), and those of wards randomized to control received no formal educational intervention. The primary outcome was the OAC prescription rate at hospital discharge in the intervention and control arms. RESULTS: Of 452 patients scrutinized, 247 were included in the analysis. Of them, 186 (75.3%) were prescribed with OACs at hospital discharge. No difference was found between the intervention and control arms in the post-intervention phase (odds ratio, 1.46; 95% confidence interval [CI], 0.81-2.64). The differences from the pre- to post-intervention phases in the proportions of patients prescribed with OACs (15.1%; 95% CI, 0%-31.5%) and with direct oral anticoagulants (DOACs) (20%; 95% CI, 0%-39.8%) increased more in the intervention than in the control arm. CONCLUSIONS: This simulation-based course did not succeed in increasing the rate of elderly patients prescribed with OACs at hospital discharge compared with the usual practice. Notwithstanding, over time there was a greater increase in the intervention than in the control arm in the proportion of patients prescribed with OACs and DOACs. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT03188211.


Assuntos
Anticoagulantes/administração & dosagem , Fibrilação Atrial/tratamento farmacológico , Simulação de Paciente , Treinamento por Simulação/métodos , Administração Oral , Idoso , Idoso de 80 Anos ou mais , Anticoagulantes/uso terapêutico , Competência Clínica/normas , Análise por Conglomerados , Educação Médica Continuada/métodos , Feminino , Geriatria/educação , Geriatria/métodos , Humanos , Masculino , Razão de Chances , Acidente Vascular Cerebral/tratamento farmacológico , Acidente Vascular Cerebral/prevenção & controle
14.
Aging Clin Exp Res ; 31(4): 511-518, 2019 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-30019265

RESUMO

BACKGROUND: Physical activities can prevent disability in elderly. AIMS: To evaluate the feasibility and impact on physical function of an adapted physical activity (APA) programme in community-dwelling people of ≥ 70 years old. METHODS: Non-blinded randomized trial with a waiting list control. Eligible people (n = 186) were randomly allocated to 4 months of weekly APA classes of 45 min or in control group performing usual lifestyle activity. PRIMARY OUTCOME: time to walk 400 m. SECONDARY OUTCOMES: short physical performance battery (SPPB), pain (visual analogic scale, McGill Questionnaire), Oswestry Disability Index (ODI), Geriatric Depression Scale (GDS), handgrip strength, accesses to Emergency Department and falls. RESULTS: Participants were allocated to the intervention (n = 130) or to the control (n = 56) group (80% females aged 75.6 ± 4.6 years). We found statistically significant difference in the time to walk 400 m only in the subgroup intervention with the lower performance at baseline (p for interaction 0.031). SPPB improved and VAS decreased more in the intervention group. No significant differences for McGill questionnaire, ODI, GDS, accesses to ER and falls were showed. DISCUSSION: Despite the good rate of attendance (71%) and satisfaction (97%), our APA programme was associated with no benefit on the time to walk 400 m and small benefit on SPPB and VAS. The efficacy of the intervention was likely limited by the short duration and low intensity and by the already good performance of our population at baseline. CONCLUSIONS: We designed this initiative as a pilot study intending to implement research of this type in the future.


Assuntos
Exercício Físico/fisiologia , Envelhecimento Saudável/fisiologia , Caminhada/fisiologia , Atividades Cotidianas , Idoso , Idoso de 80 Anos ou mais , Estudos de Viabilidade , Feminino , Humanos , Masculino , Projetos Piloto , Fatores de Tempo , Listas de Espera , Teste de Caminhada
15.
J Clin Anesth ; 52: 111-118, 2019 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-30243062

RESUMO

STUDY OBJECTIVE: To assess the effect of different intraoperative blood pressure targets on the development of POCD and test the feasibility of a larger trial. DESIGN: Randomized controlled pilot trial. SETTING: Perioperative care in a tertiary care teaching hospital with outpatient follow-up. PATIENTS: One hundred one patients aged ≥75 years with ASA physical status <4, undergoing elective, non-cardiac surgery under general anesthesia and 33 age-matched healthy controls. INTERVENTIONS: Randomization to a personalized intraoperative blood pressure target, mean arterial pressure (MAP) ≥ 90% of preoperative values (Target group), or to a more liberal intraoperative blood pressure management (No-Target group). Strategies to reach intraoperative blood pressure target were at discretion of anesthesiologists. MEASUREMENTS: An experienced neuropsychologist performed a validated battery of neurocognitive tests preoperatively and 3 months after surgery. Incidence of POCD at three months and postoperative delirium were assessed. Intraoperative time spent with MAP ≥ 90% of preoperative values, recruitment and drop-out rate at 3 months were feasibility outcomes. MAIN RESULTS: The Target group spent a higher percentage of intraoperative time with MAP ≥90% of preoperative values (65 ±â€¯25% vs. 49 ±â€¯28%, p < 0.01). Incidence of POCD (11% vs. 7%, relative risk 1.52; 95% CI, 0.41 to 6.3; p = 0.56) and delirium (6% vs. 14%, relative risk, 0.44; 95% CI, 0.12 to 1.60; p = 0.21) did not differ between groups. No correlation was found between intraoperative hypotension and postoperative cognitive performance (p = 0.75) or delirium (p = 0.19). Recruitment rate was of 6 patients/month (95% confidential interval (CI), 5 to 7) and drop-out rate at 3 months was 24% (95% CI, 14 to 33%). CONCLUSIONS: Intraoperative hypotension did not correlate with postoperative cognitive dysfunction or delirium occurrence in elderly patients undergoing general anesthesia for non-cardiac surgery. A multicenter randomized controlled trial is needed in order to confirm the effect of intraoperative blood pressure on the development of POCD. TRIAL REGISTRATION NUMBER: NCT02428062www.clinicaltrials.gov.


Assuntos
Anestesia Geral , Disfunção Cognitiva/epidemiologia , Avaliação Geriátrica/métodos , Hipotensão/epidemiologia , Complicações Intraoperatórias/epidemiologia , Complicações Pós-Operatórias/epidemiologia , Idoso de 80 Anos ou mais , Causalidade , Delírio/epidemiologia , Feminino , Humanos , Incidência , Masculino , Projetos Piloto , Estudos Prospectivos
16.
Eur J Intern Med ; 61: 62-68, 2019 03.
Artigo em Inglês | MEDLINE | ID: mdl-30391167

RESUMO

Exacerbations of chronic obstructive pulmonary disease (COPDE) frequently require hospitalizations, may necessitate of invasive mechanical ventilation (IMV), and are associated with a remarkable in-hospital mortality. The BAP-65 score is a risk assessment model (RAM) based on simple variables, that has been proposed for the prediction of these adverse outcomes in patients with COPDE. If showed to be accurate, the BAP-65 RAM might be used to guide the patients management, in terms of destination and treatment. We conducted a retrospective, multicentre, chart-review study, on patients attending the ED for a COPDE during 2014. The aim of the study was the validation of the BAP-65 RAM for the prediction of in-hospital death or use of IMV (composite primary outcome). We assessed the discrimination and the prognostic performance of the BAP-65 RAM. We enrolled 2908 patients from 20 centres across Italy. The mean (standard deviation) age was 76 (11) years, and 38% of patients were female. The composite outcome occurred in 5.3% of patients. The AUROC of BAP-65 for the composite outcome was 0.64 (95%CI 0.59-0.68). The sensitivity of BAP-65 score ≥ 4 to predict in-hospital mortality was 44% (95% CI 34%-55%), the specificity was 84% (95% CI 82%-85%), the positive predictive value was 9% (95% CI 6%-12%), and the negative predictive value was 98% (95% CI 97%-98%). CONCLUSIONS: In patients attending Italian EDs with a COPDE, we found that the BAP-65 score did not have sufficient accuracy to stratify patients upon their risk of severe in-hospital outcomes.


Assuntos
Serviço Hospitalar de Emergência/estatística & dados numéricos , Mortalidade Hospitalar , Doença Pulmonar Obstrutiva Crônica/mortalidade , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Medição de Risco/métodos , Idoso , Idoso de 80 Anos ou mais , Serviço Hospitalar de Emergência/organização & administração , Feminino , Humanos , Itália/epidemiologia , Modelos Logísticos , Masculino , Análise Multivariada , Valor Preditivo dos Testes , Prognóstico , Curva ROC , Respiração Artificial , Estudos Retrospectivos
17.
Can J Cardiol ; 34(7): 850-862, 2018 07.
Artigo em Inglês | MEDLINE | ID: mdl-29960614

RESUMO

Worldwide, more than 230 million adults have major noncardiac surgery each year. Although surgery can improve quality and duration of life, it can also precipitate major complications. Moreover, a substantial proportion of deaths occur after discharge. Current systems for monitoring patients postoperatively, on surgical wards and after transition to home, are inadequate. On the surgical ward, vital signs evaluation usually occurs only every 4-8 hours. Reduced in-hospital ward monitoring, followed by no vital signs monitoring at home, leads to thousands of cases of undetected/delayed detection of hemodynamic compromise. In this article we review work to date on postoperative remote automated monitoring on surgical wards and strategy for advancing this field. Key considerations for overcoming current barriers to implementing remote automated monitoring in Canada are also presented.


Assuntos
Monitorização Fisiológica/métodos , Cuidados Pós-Operatórios/métodos , Procedimentos Cirúrgicos Operatórios , Telemedicina/métodos , Sinais Vitais/fisiologia , Humanos
18.
Health Psychol Rev ; 12(4): 382-404, 2018 12.
Artigo em Inglês | MEDLINE | ID: mdl-29916302

RESUMO

Interventions to minimise, reverse or prevent the progression of frailty in older adults represent a potentially viable route to improving quality of life and care needs in older adults. Intervention methods used across European Innovation Partnership on Active and Healthy Ageing collaborators were analysed, along with findings from literature reviews to determine 'what works for whom in what circumstances'. A realist review of FOCUS study literature reviews, 'real-world' studies and grey literature was conducted according to RAMESES (Realist and Meta-narrative Evidence Synthesis: Evolving Standards), and used to populate a framework analysis of theories of why frailty interventions worked, and theories of why frailty interventions did not work. Factors were distilled into mechanisms deriving from theories of causes of frailty, management of frailty and those based on the intervention process. We found that studies based on resolution of a deficiency in an older adult were only successful when there was indeed a deficiency. Client-centred interventions worked well when they had a theoretical grounding in health psychology and offered choice over intervention elements. Healthcare organisational interventions were found to have an impact on success when they were sufficiently different from usual care. Compelling evidence for the reduction of frailty came from physical exercise, or multicomponent (exercise, cognitive, nutrition, social) interventions in group settings. The group context appears to improve participants' commitment and adherence to the programme. Suggested mechanisms included commitment to co-participants, enjoyment and social interaction. In conclusion, initial frailty levels, presence or absence of specific deficits, and full person and organisational contexts should be included as components of intervention design. Strategies to enhance social and psychological aspects should be included even in physically focused interventions.


Assuntos
Fragilidade/prevenção & controle , Idoso , Transtornos Cognitivos/prevenção & controle , Comunicação , Assistência à Saúde/organização & administração , Progressão da Doença , Idoso Fragilizado/psicologia , Promoção da Saúde/métodos , Estilo de Vida Saudável , Humanos , Relações Interpessoais , Desnutrição/prevenção & controle , Determinação de Necessidades de Cuidados de Saúde , Educação de Pacientes como Assunto , Medicina de Precisão/métodos , Qualidade de Vida/psicologia , Projetos de Pesquisa
20.
BMJ Open ; 8(1): e018653, 2018 01 13.
Artigo em Inglês | MEDLINE | ID: mdl-29331967

RESUMO

OBJECTIVE: To elicit European healthcare policy-makers' views, understanding and attitudes about the implementation of frailty screening and management strategies and responses to stakeholders' views. DESIGN: Thematic analysis of semistructured qualitative interviews. SETTING: European healthcare policy departments. PARTICIPANTS: Seven European healthcare policy-makers representing the European Union (n=2), UK (n=2), Italy (n=1), Spain (n=1) and Poland (n=1). Participants were sourced through professional networks and the European Commission Authentication Service website and were required to be in an active healthcare policy or decision-making role. RESULTS: Seven themes were identified. Our findings reveal a 'knowledge gap', around frailty and awareness of the malleability of frailty, which has resulted in restricted ownership of frailty by specialists. Policy-makers emphasised the need to recognise frailty as a clinical syndrome but stressed that it should be managed via an integrated and interdisciplinary response to chronicity and ageing. That is, through social co-production. This would require a culture shift in care with redeployment of existing resources to deliver frailty management and intervention services. Policy-makers proposed barriers to a culture shift, indicating a need to be innovative with solutions to empower older adults to optimise their health and well-being, while still fully engaging in the social environment. The cultural acceptance of an integrated care system theme described the complexities of institutional change management, as well as cultural issues relating to working democratically, while in signposting adult care, the need for a personal navigator to help older adults to access appropriate services was proposed. Policy-makers also believed that screening for frailty could be an effective tool for frailty management. CONCLUSIONS: There is potential for frailty to be managed in a more integrated and person-centred manner, overcoming the challenges associated with niche ownership within the healthcare system. There is also a need to raise its profile and develop a common understanding of its malleability among stakeholders, as well as consistency in how and when it is measured.


Assuntos
Pessoal Administrativo , Atitude do Pessoal de Saúde , Assistência à Saúde/métodos , Idoso Fragilizado , Fragilidade/terapia , Política de Saúde , Formulação de Políticas , Idoso , Idoso de 80 Anos ou mais , Tomada de Decisões , Europa (Continente) , União Europeia , Fragilidade/diagnóstico , Conhecimentos, Atitudes e Prática em Saúde , Recursos em Saúde , Humanos , Cultura Organizacional , Pesquisa Qualitativa , Meio Social
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