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1.
Cochrane Database Syst Rev ; 2019(10)2019 Oct 31.
Artigo em Inglês | MEDLINE | ID: mdl-31684690

RESUMO

BACKGROUND: Early enteral nutrition support (within 48 hours of admission or injury) is frequently recommended for the management of patients in intensive care units (ICU). Early enteral nutrition is recommended in many clinical practice guidelines, although there appears to be a lack of evidence for its use and benefit. OBJECTIVES: To evaluate the efficacy and safety of early enteral nutrition (initiated within 48 hours of initial injury or ICU admission) versus delayed enteral nutrition (initiated later than 48 hours after initial injury or ICU admission), with or without supplemental parenteral nutrition, in critically ill adults. SEARCH METHODS: We searched CENTRAL (2019, Issue 4), MEDLINE Ovid (1946 to April 2019), Embase Ovid SP (1974 to April 2019), CINAHL EBSCO (1982 to April 2019), and ISI Web of Science (1945 to April 2019). We also searched Turning Research Into Practice (TRIP), trial registers (ClinicalTrials.gov, ISRCTN registry), and scientific conference reports, including the American Society for Parenteral and Enteral Nutrition and the European Society for Clinical Nutrition and Metabolism. We applied no restrictions by language or publication status. SELECTION CRITERIA: We included all randomized controlled trials (RCTs) that compared early versus delayed enteral nutrition, with or without supplemental parenteral nutrition, in adults who were in the ICU for longer than 72 hours. This included individuals admitted for medical, surgical, and trauma diagnoses, and who required any type of enteral nutrition. DATA COLLECTION AND ANALYSIS: Two review authors extracted study data and assessed the risk of bias in the included studies. We expressed results as risk ratios (RR) for dichotomous data, and as mean differences (MD) for continuous data, both with 95% confidence intervals (CI). We assessed the certainty of the evidence using GRADE. MAIN RESULTS: We included seven RCTs with a total of 345 participants. Outcome data were limited, and we judged many trials to have an unclear risk of bias in several domains. Early versus delayed enteral nutrition Six trials (318 participants) assessed early versus delayed enteral nutrition in general, medical, and trauma ICUs in the USA, Australia, Greece, India, and Russia. Primary outcomes Five studies (259 participants) measured mortality. It is uncertain whether early enteral nutrition affects the risk of mortality within 30 days (RR 1.00, 95% CI 0.16 to 6.38; 1 study, 38 participants; very low-quality evidence). Four studies (221 participants) reported mortality without describing the timeframe; we did not pool these results. None of the studies reported a clear difference in mortality between groups. Three studies (156 participants) reported infectious complications. We were unable to pool the results due to unreported data and substantial clinical heterogeneity. The results were inconsistent across studies. One trial measured feed intolerance or gastrointestinal complications; it is uncertain whether early enteral nutrition affects this outcome (RR 0.84, 95% CI 0.35 to 2.01; 59 participants; very low-quality evidence). Secondary outcomes One trial assessed hospital length of stay and reported a longer stay in the early enteral group (median 15 days (interquartile range (IQR) 9.5 to 20) versus 12 days (IQR 7.5 to15); P = 0.05; 59 participants; very low-quality evidence). Three studies (125 participants) reported the duration of mechanical ventilation. We did not pool the results due to clinical and statistical heterogeneity. The results were inconsistent across studies. It is uncertain whether early enteral nutrition affects the risk of pneumonia (RR 0.77, 95% CI 0.55 to 1.06; 4 studies, 192 participants; very low-quality evidence). Early enteral nutrition with supplemental parenteral nutrition versus delayed enteral nutrition with supplemental parenteral nutrition We identified one trial in a burn ICU in the USA (27 participants). Primary outcomes It is uncertain whether early enteral nutrition with supplemental parenteral nutrition affects the risk of mortality (RR 0.74, 95% CI 0.25 to 2.18; very low-quality evidence), or infectious complications (MD 0.00, 95% CI -1.94 to 1.94; very low-quality evidence). There were no data available for feed intolerance or gastrointestinal complications. Secondary outcomes It is uncertain whether early enteral nutrition with supplemental parenteral nutrition reduces the duration of mechanical ventilation (MD 9.00, 95% CI -10.99 to 28.99; very low-quality evidence). There were no data available for hospital length of stay or pneumonia. AUTHORS' CONCLUSIONS: Due to very low-quality evidence, we are uncertain whether early enteral nutrition, compared with delayed enteral nutrition, affects the risk of mortality within 30 days, feed intolerance or gastrointestinal complications, or pneumonia. Due to very low-quality evidence, we are uncertain if early enteral nutrition with supplemental parenteral nutrition compared with delayed enteral nutrition with supplemental parenteral nutrition reduces mortality, infectious complications, or duration of mechanical ventilation. There is currently insufficient evidence; there is a need for large, multicentred studies with rigorous methodology, which measure important clinical outcomes.

2.
Lancet ; 394(10210): e35, 2019 11 09.
Artigo em Inglês | MEDLINE | ID: mdl-31685260
3.
Top Stroke Rehabil ; : 1-21, 2019 Nov 11.
Artigo em Inglês | MEDLINE | ID: mdl-31710277

RESUMO

Objective: To assess the effectiveness of Extracorporeal Shock Wave Therapy (ESWT) to reduce lower limb spasticity in adult stroke survivors.Data Sources: A systematic review of Medline/Pubmed, CENTRAL, CINAHL, PEDro database, REHABDATA, Scielo, Scopus, Web of Science, Trip Database, and Epistemonikos from 1980 to December 2018 was carried out.Review Methods: The bibliography was screened to identify clinical trials (controlled and before-after) that used ESWT to reduce spasticity in stroke survivors. Two reviewers independently screened references, selected relevant studies, extracted data, and assessed risk of bias by PEDro scale. The primary outcome was spasticity.Results: A total of 12 studies (278 participants) were included (5 randomized controlled trials, 1 controlled trial, and 6 before-after studies). A meta-analysis was performed by randomized controlled trials. A beneficial effect on spasticity was found. The mean difference (MD) was 0.58; 95% confidence interval (CI) 0.30 to 0.86 and also in subgroup analysis (short, medium, and long term). The MD for range of motion was 1.81; CI -0.20 to 3.82 and for lower limb function the standard mean difference (SMD) was 0.34; 95% CI -0.09 to 0.77. Sensitivity analysis demonstrated a better beneficial effect for myotendinous junction. MD was 1.5; 95% CI -2.44 to 5.44 at long-term (9 weeks).Conclusion: The ESWT (radial/focused) would be a good non-invasive rehabilitation strategy in chronic stroke survivors to reduce lower limb spasticity, increase ankle range of motion, and improve lower limb function. It does not show any adverse events and it is a safe and effective method.

4.
Clin Transplant ; : e13737, 2019 Oct 20.
Artigo em Inglês | MEDLINE | ID: mdl-31630456

RESUMO

INTRODUCTION AND OBJECTIVES: Heart transplantation (HT) is the treatment for patients with end-stage heart disease. Despite contradictory reports, survival seems to be worse when donor/recipient sex is mismatched. This systematic review and meta-analysis aims to synthesize the evidence on the effect of donor/recipient sex mismatch after HT. METHODS: We searched PubMed and EMBASE until November 2017. Comparative cohort and registry studies were included. Published articles were systematically selected and, when possible, pooled in a meta-analysis. The primary endpoint was one-year mortality. RESULTS: After retrieving 556 articles, ten studies (76 175 patients) were included in the quantitative meta-analysis. Significant differences were found in one-year survival between sex-matched and mismatched recipients (odds ratio (OR) 1.30, 95% confidence interval (CI) 1.25-1.35, P < .001). In female recipients, we found that sex mismatch was not a risk factor for one-year mortality (OR = 0.93, 95% CI = 0.85-1.00, P = .06). However, in male recipients, we found that it was a risk factor for one-year mortality (OR = 1.38, 95% CI = 1.31-1.44, P < .001). CONCLUSIONS: Sex mismatch increases one-year mortality after HT in male recipients. Its influence in long-term survival should be further explored with high-quality studies.

5.
J Rehabil Med ; 51(3): 201-208, 2019 Mar 13.
Artigo em Inglês | MEDLINE | ID: mdl-30667512

RESUMO

OBJECTIVE: To determine whether the appearance of a radial extracorporeal shock wave device affects clinical outcomes in chronic plantar fasciitis. STUDY DESIGN: Randomized controlled parallel assessor-blinded clinical trial. MATERIAL AND METHODS: A total of 135 patients were assigned to 3 groups: group I, standard radial extracorporeal shock wave device; group II, standard radial extracorporeal shock wave device modified to give a more sophisticated appearance; group III, standard radial extracorporeal shock wave device modified to give a more austere appearance. The radial extracorporeal shock waves emitted by the 3 devices were identical. Primary outcome was foot function, measured with the Foot Function Index. Secondary outcomes were pain at different times, measured with a visual analogue scale, and plantar fascia thickness, measured with ultrasound. RESULTS: All variables decreased significantly from baseline assessment, in all 3 groups and at all time-points: 1, 2, 4 and 14 months after the last session (p < 0.001). There were no significant differences between groups for any of the variables assessed. CONCLUSION: Device appearance had no statistically significant influence on clinical outcomes in patients with chronic plantar fasciitis treated with radial extracorporeal shock wave therapy.


Assuntos
Fasciíte Plantar/terapia , Ondas de Choque de Alta Energia/uso terapêutico , Fasciíte Plantar/patologia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Resultado do Tratamento
6.
Can J Surg ; 61(3): 185-194, 2018 06.
Artigo em Inglês | MEDLINE | ID: mdl-29806816

RESUMO

BACKGROUND: Myocardial injury after noncardiac surgery (MINS) is a mostly asymptomatic condition that is strongly associated with 30-day mortality; however, it remains mostly undetected without systematic troponin T monitoring. We evaluated the cost and consequences of postoperative troponin T monitoring to detect MINS. METHODS: We conducted a model-based cost-consequence analysis to compare the impact of routine troponin T monitoring versus standard care (troponin T measurement triggered by ischemic symptoms) on the incidence of MINS detection. Model inputs were based on Canadian patients enrolled in the Vascular Events in Noncardiac Surgery Patients Cohort Evaluation (VISION) study, which enrolled patients aged 45 years or older undergoing inpatient noncardiac surgery. We conducted probability analyses with 10 000 iterations and extensive sensitivity analyses. RESULTS: The data were based on 6021 patients (48% men, mean age 65 [standard deviation 12] yr). The 30-day mortality rate for MINS was 9.6%. We determined the incremental cost to avoid missing a MINS event as $1632 (2015 Canadian dollars). The cost-effectiveness of troponin monitoring was higher in patient subgroups at higher risk for MINS, e.g., those aged 65 years or more, or with a history of atherosclerosis or diabetes ($1309). CONCLUSION: The costs associated with a troponin T monitoring program to detect MINS were moderate. Based on the estimated incremental cost per health gain, implementation of postoperative troponin T monitoring seems appealing, particularly in patients at high risk for MINS.

7.
Ann Surg ; 268(2): 357-363, 2018 Aug.
Artigo em Inglês | MEDLINE | ID: mdl-28486392

RESUMO

OBJECTIVE: To determine the prognostic relevance, clinical characteristics, and 30-day outcomes associated with myocardial injury after noncardiac surgery (MINS) in vascular surgical patients. BACKGROUND: MINS has been independently associated with 30-day mortality after noncardiac surgery. The characteristics and prognostic importance of MINS in vascular surgery patients are poorly described. METHODS: This was an international prospective cohort study of 15,102 noncardiac surgery patients 45 years or older, of whom 502 patients underwent vascular surgery. All patients had fourth-generation plasma troponin T (TnT) concentrations measured during the first 3 postoperative days. MINS was defined as a TnT of 0.03 ng/mL of higher secondary to ischemia. The objectives of the present study were to determine (i) if MINS is prognostically important in vascular surgical patients, (ii) the clinical characteristics of vascular surgery patients with and without MINS, (iii) the 30-day outcomes for vascular surgery patients with and without MINS, and (iv) the proportion of MINS that probably would have gone undetected without routine troponin monitoring. RESULTS: The incidence of MINS in the vascular surgery patients was 19.1% (95% confidence interval (CI), 15.7%-22.6%). 30-day all-cause mortality in the vascular cohort was 12.5% (95% CI 7.3%-20.6%) in patients with MINS compared with 1.5% (95% CI 0.7%-3.2%) in patients without MINS (P < 0.001). MINS was independently associated with 30-day mortality in vascular patients (odds ratio, 9.48; 95% CI, 3.46-25.96). The 30-day mortality was similar in MINS patients with (15.0%; 95% CI, 7.1-29.1) and without an ischemic feature (12.2%; 95% CI, 5.3-25.5, P = 0.76). The proportion of vascular surgery patients who suffered MINS without overt evidence of myocardial ischemia was 74.1% (95% CI, 63.6-82.4). CONCLUSIONS: Approximately 1 in 5 patients experienced MINS after vascular surgery. MINS was independently associated with 30-day mortality. The majority of patients with MINS were asymptomatic and would have gone undetected without routine postoperative troponin measurement.

8.
J Eval Clin Pract ; 24(1): 72-79, 2018 02.
Artigo em Inglês | MEDLINE | ID: mdl-28090730

RESUMO

RATIONALE, AIMS, AND OBJECTIVES: Several studies have found that about half of research results from clinical trials are never published. Until now, there has been little information on the views that funding agencies of biomedical research in Europe have regarding this issue and its possible solutions. METHODS: An electronic survey was conducted among funding agencies from 34 European countries. Participants were asked about their opinions, policies, and potential solutions regarding dissemination bias. On the basis of the results of this survey and the input of the OPEN Consortium and of representatives of stakeholder groups in the knowledge generation process, we formulated recommendations for funding agencies to reduce dissemination bias. RESULTS: We received responses from 64 funding agencies of biomedical medicine from most European countries, out of 245 that were contacted (26%). Of these, 56 funded research at the national and/or international level and were therefore eligible to participate. Policies encouraging publication increased over time: 33 (58.9%) of agencies enforced them in 2005 compared to 38 (67.6%) in 2012. However, only 13 (23.2%) had knowledge of the publications related to research funded in 2005, 23 (41.1%) were able to provide only an estimate, and 20 (35.7%) did not know at all. Regarding recommendations to control dissemination bias, we propose that funding agencies request the dissemination of research results irrespective of the direction of findings. We also call for measures that allow evaluating funded projects past the contractual period and until dissemination of results. Funding agencies should create publicly accessible databases with information on funded projects and dissemination efforts. CONCLUSION: Despite having policies to encourage publication of results, most funding agencies fail to implement such measures or to ensure compliance. We propose recommendations that could be incorporated in the blueprint of calls for proposals and contracts agreed upon by funding agencies and grant recipients.


Assuntos
Pesquisa Biomédica/organização & administração , Ensaios Clínicos como Assunto , Ética Médica , Disseminação de Informação , Viés de Publicação/estatística & dados numéricos , Projetos de Pesquisa/estatística & dados numéricos , Ensaios Clínicos como Assunto/economia , Ensaios Clínicos como Assunto/ética , Europa (Continente) , Administração Financeira/organização & administração , Humanos , Apoio à Pesquisa como Assunto/estatística & dados numéricos
9.
BMJ Open ; 7(12): e016739, 2017 Dec 12.
Artigo em Inglês | MEDLINE | ID: mdl-29233831

RESUMO

INTRODUCTION: Proprioceptive neuromuscular facilitation (PNF) is a widely used rehabilitation concept, although its efficacy has not yet been demonstrated in stroke survivors. The aim of this systematic review is to identify, assess and synthesise the potential benefits of using PNF to improve the activities of daily living (ADL) and quality of life (QoL) of individuals with stroke. METHODS AND ANALYSIS: A systematic electronic search will be conducted in MEDLINE, Embase, CENTRAL and PEDro. We will include randomised or quasi-randomised controlled trials of PNF interventions conducted in stroke survivors up to April 2017. Two review authors will independently select relevant studies and will extract data using the Cochrane handbook for systematic reviews of interventions approach and the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols (PRISMA-P). The methodological quality will be assessed by using the PEDro scale. Finally, with the permitted numeric data, we will carry out a meta-analysis. ETHICS AND DISSEMINATION: Ethical considerations will not be required. Results will be disseminated in a peer-review journal. This systematic review aims to examine the effects of PNF (neurophysiological approach) in order to clarify its efficacy in improving ADL and QoL in the rehabilitation process of stroke survivors. PROSPERO REGISTRATION NUMBER: CRD42016039135.


Assuntos
Atividades Cotidianas , Modalidades de Fisioterapia , Qualidade de Vida , Reabilitação do Acidente Vascular Cerebral/métodos , Fenômenos Biomecânicos , Humanos , Contração Muscular/fisiologia , Manipulações Musculoesqueléticas , Postura , Anos de Vida Ajustados por Qualidade de Vida , Inquéritos e Questionários , Revisão Sistemática como Assunto
10.
Cochrane Database Syst Rev ; 12: CD009986, 2017 12 28.
Artigo em Inglês | MEDLINE | ID: mdl-29283434

RESUMO

BACKGROUND: Traumatic brain injury (TBI) is a major public health problem and a fundamental cause of morbidity and mortality worldwide. The burden of TBI disproportionately affects low- and middle-income countries. Intracranial hypertension is the most frequent cause of death and disability in brain-injured people. Special interventions in the intensive care unit are required to minimise factors contributing to secondary brain injury after trauma. Therapeutic positioning of the head (different degrees of head-of-bed elevation (HBE)) has been proposed as a low cost and simple way of preventing secondary brain injury in these people. The aim of this review is to evaluate the evidence related to the clinical effects of different backrest positions of the head on important clinical outcomes or, if unavailable, relevant surrogate outcomes. OBJECTIVES: To assess the clinical and physiological effects of HBE during intensive care management in people with severe TBI. SEARCH METHODS: We searched the following electronic databases from their inception up to March 2017: Cochrane Injuries' Specialised Register, CENTRAL, MEDLINE, Embase, three other databases and two clinical trials registers. The Cochrane Injuries' Information Specialist ran the searches. SELECTION CRITERIA: We selected all randomised controlled trials (RCTs) involving people with TBI who underwent different HBE or backrest positions. Studies may have had a parallel or cross-over design. We included adults and children over two years of age with severe TBI (Glasgow Coma Scale (GCS) less than 9). We excluded studies performed in children of less than two years of age because of their unfused skulls. We included any therapeutic HBE including supine (flat) or different degrees of head elevation with or without knee gatch or reverse Trendelenburg applied during the acute management of the TBI. DATA COLLECTION AND ANALYSIS: Two review authors independently checked all titles and abstracts, excluding references that clearly didn't meet all selection criteria, and extracted data from selected studies on to a data extraction form specifically designed for this review. There were no cases of multiple reporting. Each review author independently evaluated risk of bias through assessing sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting, and other sources of bias. MAIN RESULTS: We included three small studies with a cross-over design, involving a total of 20 participants (11 adults and 9 children), in this review. Our primary outcome was mortality, and there was one death by the time of follow-up 28 days after hospital admission. The trials did not measure the clinical secondary outcomes of quality of life, GCS, and disability. The included studies provided information only for the secondary outcomes intracranial pressure (ICP), cerebral perfusion pressure (CPP), and adverse effects.We were unable to pool the results as the data were either presented in different formats or no numerical data were provided. We included narrative interpretations of the available data.The overall risk of bias of the studies was unclear due to poor reporting of the methods. There was marked inconsistency across studies for the outcome of ICP and small sample sizes or wide confidence intervals for all outcomes. We therefore rated the quality of the evidence as very low for all outcomes and have not included the results of individual studies here. We do not have enough evidence to draw conclusions about the effect of HBE during intensive care management of people with TBI. AUTHORS' CONCLUSIONS: The lack of consistency among studies, scarcity of data and the absence of evidence to show a correlation between physiological measurements such as ICP, CCP and clinical outcomes, mean that we are uncertain about the effects of HBE during intensive care management in people with severe TBI.Well-designed and larger trials that measure long-term clinical outcomes are needed to understand how and when different backrest positions can affect the management of severe TBI.


Assuntos
Lesões Encefálicas Traumáticas/terapia , Cuidados Críticos , Cabeça , Posicionamento do Paciente/métodos , Postura , Adulto , Lesões Encefálicas Traumáticas/mortalidade , Lesões Encefálicas Traumáticas/fisiopatologia , Circulação Cerebrovascular , Criança , Estudos Cross-Over , Humanos , Pressão Intracraniana , Posicionamento do Paciente/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto
11.
Respir Res ; 18(1): 196, 2017 11 25.
Artigo em Inglês | MEDLINE | ID: mdl-29178871

RESUMO

BACKGROUND: Long-acting bronchodilators are the cornerstone of pharmacologic treatment of COPD. The new combination of long-acting muscarinic antagonist (LAMA) tiotropium (TIO) and long acting beta-agonists (LABA) olodaterol (OLO) has been introduced as fist line therapy for COPD. This article analyses the evidence of efficacy and safety of the TIO/OLO combination. METHODS: A systematic review and metaanalysis of randomized controlled trials (RCT) with a period of treatment of at least 6 weeks, in patients with COPD confirmed by spirometry, comparing combined treatment with TIO/OLO (approved doses only), with any of the mono-components or any other active comparator administered as an inhalator. RESULTS: A total of 10 Randomized controlled trials (RCT) were identified (N = 10,918). TIO/OLO significantly improved trough FEV1 from baseline to week 12 versus TIO, OLO and LABA/ICS (0.06 L, 0.09 L and between 0.04 and 0.05 L, respectively). TIO/OLO improved transitional dyspnea index (TDI) and St. George's Respiratory Questionnaire (SGRQ) compared with mono-components, with patients more likely to achieve clinically important improvements in TDI (risk ratio [RR]: 1.17, 95% confidence interval [CI]: [1.07, 1.28] versus TIO and RR: 1.14, 95%CI: [1.01, 1.28] versus OLO) and in SGRQ (RR: 1.21, 95%CI: [1.12, 1.30] versus TIO and RR: 1.28, 95%CI: [1.18, 1.40] versus OLO). Patients treated with TIO/OLO showed a significant reduction in the use of rescue medication and no significant differences in frequency of general and serious adverse events were observed between TIO/OLO and mono-components. CONCLUSIONS: Treatment with TIO/OLO provided significant improvements in lung function versus mono-components and LABA/ICS with more patients achieving significant improvements in dyspnea and health status. No differences in adverse events were observed compared with other active treatments. CLINICAL TRIAL REGISTRATION: PROSPERO register of systematic reviews ( CRD42016040162 ).


Assuntos
Agonistas de Receptores Adrenérgicos beta 2/administração & dosagem , Benzoxazinas/administração & dosagem , Broncodilatadores/administração & dosagem , Antagonistas Muscarínicos/administração & dosagem , Doença Pulmonar Obstrutiva Crônica/tratamento farmacológico , Doença Pulmonar Obstrutiva Crônica/fisiopatologia , Brometo de Tiotrópio/administração & dosagem , Administração por Inalação , Combinação de Medicamentos , Volume Expiratório Forçado/efeitos dos fármacos , Volume Expiratório Forçado/fisiologia , Humanos , Doença Pulmonar Obstrutiva Crônica/diagnóstico , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Espirometria/métodos , Resultado do Tratamento
12.
BMC Med Res Methodol ; 17(1): 135, 2017 Sep 07.
Artigo em Inglês | MEDLINE | ID: mdl-28882125

RESUMO

BACKGROUND: Gastrointestinal Stromal Tumours (GISTs) are the most common mesenchymal tumours. Currently, different pharmacological and surgical options are used to treat localised and metastatic GISTs, although this research field is broad and the body of evidence is scattered and expanding. Our objectives are to identify, describe and organise the current available evidence for GIST through an evidence mapping approach. METHODS: We followed the methodology of Global Evidence Mapping (GEM). We searched Pubmed, EMBASE, The Cochrane Library and Epistemonikos in order to identify systematic reviews (SRs) with or without meta-analyses published between 1990 and March 2016. Two authors assessed eligibility and extracted data. Methodological quality of the included systematic reviews was assessed using AMSTAR. We organised the results according to identified PICO questions and presented the evidence map in tables and a bubble plot. RESULTS: A total of 17 SRs met eligibility criteria. These reviews included 66 individual studies, of which three quarters were either observational or uncontrolled clinical trials. Overall, the quality of the included SRs was moderate or high. In total, we extracted 14 PICO questions from them and the corresponding results mostly favoured the intervention arm. CONCLUSIONS: The most common type of study used to evaluate therapeutic interventions in GIST sarcomas has been non-experimental studies. However, the majority of the interventions are reported as beneficial or probably beneficial by the respective authors of SRs. The evidence mapping is a useful and reliable methodology to identify and present the existing evidence about therapeutic interventions.


Assuntos
Prática Clínica Baseada em Evidências , Neoplasias Gastrointestinais/terapia , Tumores do Estroma Gastrointestinal/terapia , Humanos , Literatura de Revisão como Assunto
13.
Contemp Clin Trials ; 61: 16-22, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28687347

RESUMO

BACKGROUND: Several hemostatic treatments intended to reduce the bleeding associated to total knee arthroplasty have been investigated with varying degrees of success. TT-173 is a new topical agent based on recombinant tissue factor that activates the extrinsic pathway of coagulation. This trial aim is to evaluate the efficacy and safety of TT-173 in total knee arthroplasty. METHODS/DESIGN: This is a phase II/III, sequential, simple blind, randomized, multicenter, placebo controlled and parallel clinical trial that will recruit 189 evaluable patients. Those randomized to treatment group will receive 2mg of TT-173 over the surgical surfaces of the knee. Control patients will receive physiologic saline. The follow up will consist in 6 visits during a period of 35 (±7) days. Primary endpoints will be the total blood loss and the incidence and severity of adverse events. Secondary and exploratory endpoints will include drainage production, decrease in hemoglobin level, transfusion ratio, analytical alterations, pain intensity, motion range, immunogenicity of TT-173 and the occurrence of systemic absorption. At the end of phase II, results will be evaluated by an independent committee that will recommend the continuation or the discontinuation of the trial. DISCUSSION: The design proposed maximizes the safety of the participants, avoids the risk of bias derived from the limitations of masking and enable the eventual discontinuation of the trial if this is recommended by the Interim Analysis Committee. If TT-173 proves its efficacy and safety in this indication, it would become a useful tool to improve the bleeding control in total knee arthroplasty. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02687399. Registered the 9th of February 2016.


Assuntos
Artroplastia do Joelho/métodos , Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Tromboplastina/uso terapêutico , Humanos , Projetos de Pesquisa , Método Simples-Cego
14.
Med. clín (Ed. impr.) ; 149(1): 26-31, jul. 2017. graf
Artigo em Espanhol | IBECS | ID: ibc-164388

RESUMO

Cuando administramos un tratamiento físico o farmacológico, existen muchas variables que pueden explicar la mejoría clínica que experimenta un paciente. El principio activo del fármaco o el agente físico aplicado son importantes, pero también hay que sumarle otros elementos presentes en el contexto de la relación paciente-terapeuta. La evidencia científica ha demostrado que el efecto placebo existe. Se trata de un auténtico fenómeno biopsicosocial producido por el contexto en el cual se lleva a cabo una intervención. Sesgos al margen, las respuestas placebo y nocebo son cambios en los síntomas de los pacientes atribuibles a su participación en el encuentro terapéutico, con sus rituales, símbolos e interacciones. Esta multitud de señales inherentes a toda intervención son percibidas e interpretadas por los pacientes, generando expectativas positivas o negativas (AU)


When we apply a physical or pharmacological treatment, there are many things that may explain the clinical improvement experienced by a patient. The drugs or physical agents applied are important, but we must also add other elements in the context of the patient-therapist relationship. Scientific evidence has proven that the placebo effect exists. This is a true biopsychosocial phenomenon produced by the context in which an intervention is carried out. Biases aside, placebo and nocebo responses are changes in patients’ symptoms, due to their participation at the therapeutic meeting, with its rituals, symbols and interactions. This multitude of signals inherent in any intervention, is perceived and interpreted by patients and can create positive or negative expectations (AU)


Assuntos
Humanos , Efeito Placebo , Placebos/farmacocinética , Avaliação de Sintomas , Relações Médico-Paciente , Efeito Nocebo , Drogas em Investigação/farmacocinética , Resultado do Tratamento
15.
Trials ; 18(1): 273, 2017 06 13.
Artigo em Inglês | MEDLINE | ID: mdl-28610638

RESUMO

BACKGROUND: Systematic reviews provide the best evidence on the effect of health care interventions. They rely on comprehensive access to the available scientific literature. Electronic search strategies alone may not suffice, requiring the implementation of a handsearching approach. We have developed a database to provide an Internet-based platform from which handsearching activities can be coordinated, including a procedure to streamline the submission of these references into CENTRAL, the Cochrane Collaboration Central Register of Controlled Trials. METHODS: We developed a database and a descriptive analysis. Through brainstorming and discussion among stakeholders involved in handsearching projects, we designed a database that met identified needs that had to be addressed in order to ensure the viability of handsearching activities. Three handsearching teams pilot tested the proposed database. Once the final version of the database was approved, we proceeded to train the staff involved in handsearching. RESULTS: The proposed database is called BADERI (Database of Iberoamerican Clinical Trials and Journals, by its initials in Spanish). BADERI was officially launched in October 2015, and it can be accessed at www.baderi.com/login.php free of cost. BADERI has an administration subsection, from which the roles of users are managed; a references subsection, where information associated to identified controlled clinical trials (CCTs) can be entered; a reports subsection, from which reports can be generated to track and analyse the results of handsearching activities; and a built-in free text search engine. BADERI allows all references to be exported in ProCite files that can be directly uploaded into CENTRAL. To date, 6284 references to CCTs have been uploaded to BADERI and sent to CENTRAL. The identified CCTs were published in a total of 420 journals related to 46 medical specialties. The year of publication ranged between 1957 and 2016. CONCLUSIONS: BADERI allows the efficient management of handsearching activities across different countries and institutions. References to all CCTs available in BADERI can be readily submitted to CENTRAL for their potential inclusion in systematic reviews.


Assuntos
Ensaios Clínicos Controlados como Assunto/métodos , Mineração de Dados/métodos , Bases de Dados Factuais , Internet , Literatura de Revisão como Assunto , Medicina Baseada em Evidências , Humanos
16.
Med Clin (Barc) ; 149(1): 26-31, 2017 Jul 07.
Artigo em Inglês, Espanhol | MEDLINE | ID: mdl-28521961

RESUMO

When we apply a physical or pharmacological treatment, there are many things that may explain the clinical improvement experienced by a patient. The drugs or physical agents applied are important, but we must also add other elements in the context of the patient-therapist relationship. Scientific evidence has proven that the placebo effect exists. This is a true biopsychosocial phenomenon produced by the context in which an intervention is carried out. Biases aside, placebo and nocebo responses are changes in patients' symptoms, due to their participation at the therapeutic meeting, with its rituals, symbols and interactions. This multitude of signals inherent in any intervention, is perceived and interpreted by patients and can create positive or negative expectations.


Assuntos
Efeito Placebo , Relações Profissional-Paciente , Atitude Frente a Saúde , Comportamento Ritualístico , Humanos , Efeito Nocebo , Simbolismo
17.
Top Stroke Rehabil ; 24(6): 472-478, 2017 09.
Artigo em Inglês | MEDLINE | ID: mdl-28406071

RESUMO

BACKGROUND: Function in Sitting Test (FIST) is a clinical functional assessment of sitting balance validated in adults with stroke. For a major use of this, the test is recommended to be translated in Spanish-speaking countries. OBJECTIVES: Translate to Spanish the FIST and determine its intra-rater and inter-rater reliabilities and concurrent validity as a measure of sitting balance in adult individuals with stroke. METHODS: The original version was translated into Spanish and was agreed by a team of experts. A back-translation into English was subsequently performed and sent to the original author, who approved this version named from now Spanish version of Function in Sitting Test (S-FIST). Sixty post-stroke patients' performance was recorded on a videotape. These videos were then used to carry out four measurements to assess the intra-rater and inter-rater reliabilities; two of these were performed by the same rater and the third and fourth by a second and third rater. RESULTS: The S-FIST meets the following requirements: good construct validity and high correlation with Spanish version of Trunk Impairment Scale 2.0 (S-TIS 2.0) scores (r = 0.791) Spearman's rank, high internal consistency (Cronbach's α-coefficient = 0.97), and high intra-rater and inter-rater reliabilities for the summed scores assessed by intra-class correlation coefficient were 0.999 and 0.997, respectively. CONCLUSIONS: The S-FIST is valid and reliable and can be recommended for use in the evaluation of dynamic and sitting balance and trunk control in future research and clinical practice on post-stroke patients. Guidelines for treatment and level of quality of trunk activity can be derived from its use.


Assuntos
Avaliação de Resultados (Cuidados de Saúde)/métodos , Equilíbrio Postural/fisiologia , Transtornos das Sensações/etiologia , Reabilitação do Acidente Vascular Cerebral , Acidente Vascular Cerebral/complicações , Tradução , Idoso , Idoso de 80 Anos ou mais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Reprodutibilidade dos Testes , Transtornos das Sensações/reabilitação , Estatística como Assunto
18.
Clin Rehabil ; 31(11): 1492-1499, 2017 Nov.
Artigo em Inglês | MEDLINE | ID: mdl-28351168

RESUMO

OBJECTIVE: Analyse the effect of core stability exercises in addition to conventional physiotherapy training three months after the intervention ended. DESIGN: A randomized controlled trial. SETTING: Outpatient services. SUBJECTS: Seventy-nine stroke survivors. INTERVENTIONS: In the intervention period, both groups underwent conventional physiotherapy performed five days/week for five weeks, and in addition the experimental group performed core stability exercises for 15 minutes/day. Afterwards, during a three-month follow-up period, both groups underwent usual care that could eventually include conventional physiotherapy or physical exercise but not in a controlled condition. MAIN MEASURES: Primary outcome was trunk control and dynamic sitting balance assessed by the Spanish-Version of Trunk Impairment Scale 2.0 and Function in Sitting Test. Secondary outcomes were standing balance and gait evaluated by the Berg Balance Scale, Tinetti Test, Brunel Balance Assessment, Spanish-Version of Postural Assessment Scale for Stroke and activities of daily living using the Barthel Index. RESULTS: A total of 68 subjects out of 79 completed the three-month follow-up period. The mean difference (SD) between groups was 0.78 (1.51) points ( p = 0.003) for total score on the Spanish-Version of Trunk Impairment Scale 2.0, 2.52 (6.46) points ( p = 0.009) for Function in Sitting Test, dynamic standing balance was 3.30 (9.21) points ( p= 0.009) on the Berg Balance Scale, gait was 0.82 (1.88) points ( p = 0.002) by Brunel Balance Assessment (stepping), and 1.11 (2.94) points ( p = 0.044) by Tinetti Test (gait), all in favour of core stability exercises. CONCLUSIONS: Core stability exercises plus conventional physiotherapy have a positive long-term effect on improving dynamic sitting and standing balance and gait in post-stroke patients.

20.
J Epidemiol Community Health ; 71(7): 663-672, 2017 07.
Artigo em Inglês | MEDLINE | ID: mdl-27834223

RESUMO

BACKGROUND: Observational studies show that social capital is a protective health factor. Therefore, we aim to assess the currently unclear health impact of social capital interventions targeting older adults. METHODS: We conducted a systematic review based on a logic model. Studies published between January 1980 and July 2015 were retrieved from MEDLINE, EMBASE, CINAHL, PsycINFO, Cochrane Central Register of Controlled Trials and Web of Science. We included randomised controlled trials targeting participants over 60 years old and focused on social capital or its components (eg, social support and social participation). The comparison group should not promote social capital. We assessed risk of bias and impact on health outcomes and use of health-related resources applying a procedure from the Canadian Agency for Drugs and Technologies in Health (CADTH) based on vote-counting and standardised decision rules. The review protocol was registered in PROSPERO (reference number CRD42014015362). RESULTS: We examined 17 341 abstracts and included 73 papers reporting 36 trials. Trials were clinically and methodologically diverse and reported positive effects in different contexts, populations and interventions across multiple subjective and objective measures. According to sufficiently reported outcomes, social capital interventions showed mixed effects on quality of life, well-being and self-perceived health and were generally ineffective on loneliness, mood and mortality. Eight trials with high quality showed favourable impacts on overall, mental and physical health, mortality and use of health-related resources. CONCLUSIONS: Our review highlights the lack of evidence and the diversity among trials, while supporting the potential of social capital interventions to reach comprehensive health effects in older adults.


Assuntos
Qualidade de Vida , Capital Social , Idoso , Canadá , Humanos , Pessoa de Meia-Idade , Participação Social , Apoio Social
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