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1.
Disabil Rehabil Assist Technol ; : 1-11, 2021 Feb 12.
Artículo en Inglés | MEDLINE | ID: mdl-33576299

RESUMEN

PURPOSE: Stroke is one of the leading causes of disability in the adult population. It is feasible to think about the use of telerehabilitation devices, such as the smartphone, to respond to the growing demand, even in isolation cases, such as during confinement due to coronavirus disease in 2020. It is intended to explore the available Apps for Spanish-speaking patients with Stroke for a specific sensory-motor rehabilitation process. MATERIALS AND METHODS: A search of the available apps in Google Play and Apple Store was carried out using the keywords "Stroke", "hemiplegia" and "hemiparesis". The Apps detected have been described and evaluated by an anonymous survey among stroke survivors. RESULTS: Nine Apps have been identified and explored, four of which are available in Spanish: "NeuroRHB", "Stroke Hope Health4TheWorld", "9zest stroke recovery" and "Farmalarm". Twelve survivors with stroke have participated in the anonymous survey evaluating with the best score the App "Farmalarm". CONCLUSIONS: There are few specific Apps for the Stroke rehabilitation of sensory-motor impairments, and with important limitations that prevent their incorporation into clinical practice. The creation and adaptation of Apps for health professionals such as physiotherapists and occupational therapists and their users are recommended. Implications for rehabilitation It is necessary to create and adapt specific telerehabilitation tools to address sensory-motor disorders. Telerehabilitation should be introduced in the clinical practice of physiotherapy and occupational therapy. Telerehabilitation via App can be a solution, easily accessible by patients, to reduce healthcare inequality, intensify the rehabilitation process and provide continuity after discharge from the hospital.

2.
F1000Res ; 9: 226, 2020.
Artículo en Inglés | MEDLINE | ID: mdl-33335712

RESUMEN

Background: The quality of reporting of acupuncture interventions is critical to ensure the applicability and reproducibility of acupuncture clinical trials. In the past, different publications have evaluated the quality of reporting of acupuncture interventions for different clinical situations, such as knee osteoarthritis, neurological diseases or cancer. However, this has not been done for acupuncture trials for chronic obstructive pulmonary disease (COPD). Objective: To assess the quality of reporting of acupuncture interventions in trials for COPD. Methods: A total of 11 English and Chinese databases were screened up until May 2019 for randomised or quasi-randomised control trials of acupuncture for COPD. The STRICTA checklist was used to determine the quality of the reporting of acupuncture interventions. Results: A total of 28 trials were included in our review. Out of the 16 STRICTA checklist subitems analysed, only 3 were considered appropriately reported in more than 70% of the trials, while 7 were correctly reported in less than 40%. Conclusion: The adherence to STRICTA guidelines of acupuncture trials for COPD is suboptimal, and future efforts need to be addressed to improve the quality of reporting.

3.
J Clin Epidemiol ; 130: 96-106, 2020 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-33144246

RESUMEN

OBJECTIVES: The aim of this study was to quantify and analyze the presence and type of self-acknowledged limitations (SALs) in a sample of manual therapy (MT) randomized controlled trials. STUDY DESIGN AND SETTING: We randomly selected 120 MT trials. We extracted data related to SALs from the original reports and classified them into 12 categories. After data extraction, specific limitations within each category were identified. A descriptive analysis was performed using frequencies and percentages for qualitative variables. RESULTS: The number of SALs per trial article ranged from 0 to 8, and more than two-thirds of trials acknowledged at least two different limitations. Despite its small proportion, 9% of trials did not report SALs. The most common limitation declared, in almost half of our sample, related to sample size (47.5%) followed by limitations related to study length and follow-up (33.3%) and inadequate controls (32.5%). CONCLUSION: Our results indicate that at least two different limitations are consistently acknowledged in MT trial reports, the most common being those related to sample size, study length, follow-up, and inadequate controls. Analysis of the reasons behind the SALs gives some insights about the main difficulties in conducting research in this field and may help develop strategies to improve future research.

4.
Medicine (Baltimore) ; 99(21): e20127, 2020 May 22.
Artículo en Inglés | MEDLINE | ID: mdl-32481281

RESUMEN

BACKGROUND: Venous thromboembolism (VTE) is a serious, sometimes life-threatening complication that can occur following spine surgery. The incidence of VTE, and the optimal type and timing of thromboprophylaxis for this complication in elective spine surgery is a matter of debate. OBJECTIVE: To perform a systematic review with the aim of clarifying the efficacy and adverse effects of mechanical and chemical prophylaxis for preventing thromboembolic complications in elective spine surgery for conditions other than trauma and malignant disease. METHODS/DESIGN: A search strategy of related articles up to March 2018 was designed and executed in Medline and Embase. PATIENTS: adolescents (>10 years) and adults undergoing elective surgery for spinal deformity or degenerative disease (from C1 to S1). INTERVENTION: Perioperative mechanical and chemical thromboprophylaxis. Studies could be randomized controlled trials or observational studies that reported data on any relevant clinical outcomes. RESULTS: In total, 2451 uniquecitations were identified and 35 studies were ultimately included in the systematic review. The overall mean incidence of complications was 3.7% for deep venous thrombosis, 0.0% for pulmonary embolism, and 3.7% for bleeding in chemoprophylaxis group; 2.9% for deep venous thrombosis, 0.4% for pulmonary embolism and 0.0% for bleeding in mechanoprophylaxis; and 0.7% for deep venous thrombosis, 0.1% for pulmonary embolism and 0.2% for bleeding in mixed prophylaxis group with no specific data on these rates for the type of patient and type and location of surgery. None of the articles retrieved provided information on the adolescent population. DISCUSSION AND CONCLUSIONS: The poor design and high variability among the studies regarding characteristics of study population, details of interventions, and definitions of outcomes, determines a low quality of the available evidence and limits the interpretation of the results. We were unable to identify a clear advantage of one type of thromboprophylaxis over the other, although there was an increased risk of bleeding with chemoprophylaxis, which could favor the use of mechanoprophylaxis in this scenario.


Asunto(s)
Procedimientos Neuroquirúrgicos/efectos adversos , Complicaciones Posoperatorias/prevención & control , Columna Vertebral/cirugía , Tromboembolia Venosa/prevención & control , Procedimientos Quirúrgicos Electivos/efectos adversos , Humanos , Metaanálisis como Asunto , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/terapia , Revisiones Sistemáticas como Asunto , Tromboembolia Venosa/etiología , Tromboembolia Venosa/terapia
5.
BMJ Open ; 10(5): e035927, 2020 05 06.
Artículo en Inglés | MEDLINE | ID: mdl-32381536

RESUMEN

INTRODUCTION: Sepsis is a leading cause of mortality in critically ill patients. Recently, it has been recognised that sex may contribute to a differential risk for developing sepsis and it remains uncertain if the prognosis of sepsis varies between the sexes. The aim of this systematic review is to summarise the available evidence to assess the role of sex as a prognostic factor in patients with sepsis managed in the intensive care unit (ICU). METHODS AND ANALYSIS: This is a systematic review protocol of prognostic studies of sex in patients with sepsis managed in the ICU. The primary outcomes include all-cause hospital mortality and all-cause hospital mortality during the first 28 days. The secondary outcomes include all-cause hospital mortality during the first 7 days and all-cause mortality at 1 year. We will conduct a search strategy based on the population (sepsis), the prognostic factor (sex), the outcome of interest (mortality) and prognostic study methods. We will search in the following databases up to December 2019: MEDLINE Ovid (from 1976), Embase Elsevier (from 1974), Web of Science and two trial registries. We will impose no language restrictions. Two authors will independently screen titles, abstracts and full-text articles for eligibility of studies, and subsequently extract data. Two authors will independently assess the risk of bias of each study using the Quality in Prognostic Studies (QUIPS) tool. If possible, we will carry out a meta-analysis to provide a pooled prognostic effect estimate for each outcome. We will use the Grading of Recommendations Assessment, Development and Evaluation system to assess the quality of evidence. ETHICS AND DISSEMINATION: Ethical approval will not be required. Findings from this review will be reported in a peer-reviewed scientific journal. Additionally, the results will be disseminated at conferences and in the mass media. PROSPERO REGISTRATION NUMBER: CRD42019145054.

6.
J Clin Epidemiol ; 121: 32-44, 2020 05.
Artículo en Inglés | MEDLINE | ID: mdl-31972276

RESUMEN

OBJECTIVE: The aim of this review was to evaluate a selection of major reporting aspects in manual therapy (MT) trials, before and after the publication of the CONSORT extension for nonpharmacological trials (CONSORTnpt) STUDY DESIGN AND SETTING: We randomly selected 100 MT trials published between 2000 and 2015 and divided them into a pre-CONSORTnpt (n = 50) and a post-CONSORTnpt (n = 50) group. We extracted data on relevant issues of internal validity, reliability, and description of interventions. Two authors extracted data independently. Percentages were used for descriptive analyses, and Fisher's exact test and the chi-square test were used for group comparisons. RESULTS: Six different types of MT interventions with up to 20 controls were analyzed. The most common populations/conditions studied were healthy subjects and subjects with lower back or neck pain. Over 70% of studies included multi-session interventions, and 42% of studies reported long-term followup. The only significant differences between groups were the inclusion of a flowchart diagram, the estimated effect size, precision descriptions, and the description of intervention procedures. CONCLUSION: Our findings suggest that trials in MT show poor reporting even after the availability of standardized guidelines.

7.
Top Stroke Rehabil ; 27(2): 137-157, 2020 03.
Artículo en Inglés | MEDLINE | ID: mdl-31710277

RESUMEN

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.

8.
Cochrane Database Syst Rev ; 2019(10)2019 10 31.
Artículo en Inglés | MEDLINE | ID: mdl-31684690

RESUMEN

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.


Asunto(s)
Enfermedad Crítica/terapia , Nutrición Enteral/métodos , Nutrición Parenteral/métodos , Terapia Combinada/métodos , Humanos , Unidades de Cuidados Intensivos , Desnutrición/prevención & control , Ensayos Clínicos Controlados Aleatorios como Asunto , Factores de Tiempo
9.
Lancet ; 394(10210): e35, 2019 11 09.
Artículo en Inglés | MEDLINE | ID: mdl-31685260
10.
Clin Transplant ; 33(12): e13737, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-31630456

RESUMEN

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.


Asunto(s)
Rechazo de Injerto/mortalidad , Cardiopatías/mortalidad , Cardiopatías/cirugía , Trasplante de Corazón/mortalidad , Donantes de Tejidos/estadística & datos numéricos , Receptores de Trasplantes/estadística & datos numéricos , Rechazo de Injerto/etiología , Rechazo de Injerto/patología , Supervivencia de Injerto , Trasplante de Corazón/efectos adversos , Humanos , Estudios Observacionales como Asunto , Pronóstico , Factores de Riesgo , Factores Sexuales , Tasa de Supervivencia
11.
Cardiol Res Pract ; 2019: 7543917, 2019.
Artículo en Inglés | MEDLINE | ID: mdl-30931154

RESUMEN

Background: Leukocytes contained in the allogeneic packed red blood cell (PRBC) are the cause of certain adverse reactions associated with blood transfusion. Leukoreduction consists of eliminating leukocytes in all blood products below the established safety levels for any patient type. In this systematic review, we appraise the clinical effectiveness of allogeneic leukodepleted (LD) PRBC transfusion for preventing infections and death in patients undergoing major cardiovascular surgical procedures. Methods: We searched randomized controlled trials (RCT), enrolling patients undergoing a major cardiovascular surgical procedure and transfused with LD-PRBC. Data were extracted, and risk of bias was assessed according to Cochrane guidelines. In addition, trial sequential analysis (TSA) was used to assess the need of conducting additional trials. Quality of the evidence was assessed using the GRADE approach. Results: Seven studies met the eligibility criteria. Quality of the evidence was rated as moderate for both outcomes. The risk ratio for death from any cause comparing the LD-PRBC versus non-LD-PRBC group was 0.69 (CI 95% = 0.53 to 0.90; I 2 = 0%). The risk ratio for infection in the same comparison groups was 0.77 (CI 95% = 0.66 to 0.91; I 2 = 0%). TSA showed a conclusive result in this outcome. Conclusions: We found evidence that supports the routine use of leukodepletion in patients undergoing a major cardiovascular surgical procedure requiring PRBC transfusion to prevent death and infection. In the case of infection, the evidence should be considered sufficient and conclusive and hence indicated that further trials would not be required.

12.
J Rehabil Med ; 51(3): 201-208, 2019 Mar 13.
Artículo en Inglés | MEDLINE | ID: mdl-30667512

RESUMEN

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.


Asunto(s)
Fascitis Plantar/terapia , Ondas de Choque de Alta Energía/uso terapéutico , Fascitis Plantar/patología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Resultado del Tratamiento
13.
Can J Surg ; 61(3): 185-194, 2018 06.
Artículo en Inglés | MEDLINE | ID: mdl-29806816

RESUMEN

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.


Asunto(s)
Análisis Costo-Beneficio , Isquemia Miocárdica , Evaluación de Resultado en la Atención de Salud , Cuidados Posoperatorios , Complicaciones Posoperatorias , Procedimientos Quirúrgicos Operativos/efectos adversos , Troponina T/sangre , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/sangre , Isquemia Miocárdica/diagnóstico , Isquemia Miocárdica/economía , Isquemia Miocárdica/mortalidad , Evaluación de Resultado en la Atención de Salud/economía , Cuidados Posoperatorios/economía , Cuidados Posoperatorios/métodos , Cuidados Posoperatorios/normas , Complicaciones Posoperatorias/sangre , Complicaciones Posoperatorias/diagnóstico , Complicaciones Posoperatorias/economía , Complicaciones Posoperatorias/mortalidad , Riesgo
14.
J Eval Clin Pract ; 24(1): 72-79, 2018 02.
Artículo en Inglés | MEDLINE | ID: mdl-28090730

RESUMEN

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.


Asunto(s)
Investigación Biomédica/organización & administración , Ensayos Clínicos como Asunto , Ética Médica , Difusión de la Información , Sesgo de Publicación/estadística & datos numéricos , Proyectos de Investigación/estadística & datos numéricos , Ensayos Clínicos como Asunto/economía , Ensayos Clínicos como Asunto/ética , Europa (Continente) , Administración Financiera/organización & administración , Humanos , Apoyo a la Investigación como Asunto/estadística & datos numéricos
15.
Ann Surg ; 268(2): 357-363, 2018 08.
Artículo en Inglés | MEDLINE | ID: mdl-28486392

RESUMEN

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.


Asunto(s)
Isquemia Miocárdica/diagnóstico , Complicaciones Posoperatorias/diagnóstico , Troponina T/sangre , Procedimientos Quirúrgicos Vasculares , Anciano , Anciano de 80 o más Años , Biomarcadores/sangre , Femenino , Humanos , Incidencia , Masculino , Persona de Mediana Edad , Isquemia Miocárdica/sangre , Isquemia Miocárdica/epidemiología , Isquemia Miocárdica/etiología , Oportunidad Relativa , Complicaciones Posoperatorias/sangre , Complicaciones Posoperatorias/epidemiología , Pronóstico , Modelos de Riesgos Proporcionales , Estudios Prospectivos
16.
BMJ Open ; 7(12): e016739, 2017 Dec 12.
Artículo en Inglés | MEDLINE | ID: mdl-29233831

RESUMEN

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.


Asunto(s)
Actividades Cotidianas , Modalidades de Fisioterapia , Calidad de Vida , Rehabilitación de Accidente Cerebrovascular/métodos , Fenómenos Biomecánicos , Humanos , Contracción Muscular/fisiología , Manipulaciones Musculoesqueléticas , Postura , Años de Vida Ajustados por Calidad de Vida , Encuestas y Cuestionarios , Revisiones Sistemáticas como Asunto
17.
Cochrane Database Syst Rev ; 12: CD009986, 2017 12 28.
Artículo en Inglés | MEDLINE | ID: mdl-29283434

RESUMEN

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.


Asunto(s)
Lesiones Traumáticas del Encéfalo/terapia , Cuidados Críticos , Cabeza , Posicionamiento del Paciente/métodos , Postura , Adulto , Lesiones Traumáticas del Encéfalo/mortalidad , Lesiones Traumáticas del Encéfalo/fisiopatología , Circulación Cerebrovascular , Niño , Estudios Cruzados , Humanos , Presión Intracraneal , Posicionamiento del Paciente/efectos adversos , Ensayos Clínicos Controlados Aleatorios como Asunto
18.
Respir Res ; 18(1): 196, 2017 11 25.
Artículo en Inglés | MEDLINE | ID: mdl-29178871

RESUMEN

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 ).


Asunto(s)
Agonistas de Receptores Adrenérgicos beta 2/administración & dosificación , Benzoxazinas/administración & dosificación , Broncodilatadores/administración & dosificación , Antagonistas Muscarínicos/administración & dosificación , Enfermedad Pulmonar Obstructiva Crónica/tratamiento farmacológico , Enfermedad Pulmonar Obstructiva Crónica/fisiopatología , Bromuro de Tiotropio/administración & dosificación , Administración por Inhalación , Combinación de Medicamentos , Volumen Espiratorio Forzado/efectos de los fármacos , Volumen Espiratorio Forzado/fisiología , Humanos , Enfermedad Pulmonar Obstructiva Crónica/diagnóstico , Ensayos Clínicos Controlados Aleatorios como Asunto/métodos , Espirometría/métodos , Resultado del Tratamiento
19.
BMC Med Res Methodol ; 17(1): 135, 2017 Sep 07.
Artículo en Inglés | MEDLINE | ID: mdl-28882125

RESUMEN

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.


Asunto(s)
Práctica Clínica Basada en la Evidencia , Neoplasias Gastrointestinales/terapia , Tumores del Estroma Gastrointestinal/terapia , Humanos , Literatura de Revisión como Asunto
20.
Contemp Clin Trials ; 61: 16-22, 2017 10.
Artículo en Inglés | MEDLINE | ID: mdl-28687347

RESUMEN

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.


Asunto(s)
Artroplastia de Reemplazo de Rodilla/métodos , Hemostasis Quirúrgica/métodos , Hemostáticos/uso terapéutico , Tromboplastina/uso terapéutico , Humanos , Proyectos de Investigación , Método Simple Ciego
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