Implementing living evidence to inform health decisions: A strategy for building capacity in health sector (Protocol).

Every day important healthcare decisions are made with incomplete or outdated information about the effects of the healthcare interventions available, what delivers the best value for the health system and where more research is needed. It is necessary to invest in strategies that allow access to reliable and updated evidence on which to base health decisions. The objective is to develop and evaluate a strategy for building the capacity among different actors of a country's health system to implement the model known as "Living Evidence" [LE] in the evidence synthesis and dissemination of knowledge transfer [KT] products to inform health decisions. The study will involve professional members of health system organizations in charge of developing KT products to inform health decisions. The project will be developed in three complementary phases: 1) LE-implementation framework development through review of the literature, brainstorming meetings, user testing, and expert consultation; 2) training in LE tools and strategies; 3) developing LE synthesis for KT products by applying the framework to real-life diverse situations. To achieve the capacity-building strategy assessment goal, several surveys and interviews will take place during the process to assess: 1) the LE-implementation framework for the incorporation of LE synthesis in the development of KT products; 2) the training workshops; 3) the whole capacity-building strategy used for health system organizations be able of implementing the LE as part of the KT products they regularly produce. The expected results are an effective capacity-building strategy for health system organizations to implement the living evidence model in different KT products; a LE-implementation framework to be applicable to any country or region to incorporate LE in the KT products; LE synthesis for KT products directly applicable to the real-setting situations; integration of Epistemonikos-L.OVE platform for keeping the LE process in the development and updating of KT products.

Methodological approaches for developing and reporting living evidence synthesis: a study protocol.

Background: Living evidence (LE) refers to the methodological processes that permit new research findings to be continually incorporated into evidence synthesis. This approach is of great value in the resolution of relevant and rapidly changing clinical questions. To date, the methods to carry out this type of synthesis are not completely defined, and great variability is observed in the approaches used by different groups of authors. Objective: To identify, evaluate and summarise the current methods used for living evidence synthesis Methods: We will conduct a methodological study based on a systematic literature search to identify any type of evidence synthesis such as systematic reviews, network metanalyses and overviews that used "living evidence synthesis" as part of their methods. The search will be conducted in Medline (via PubMed) and Epistemonikos databases. Additionally, we will search websites of the organisations publishing any living evidence synthesis retrieved in the two databases, in order to identify unpublished subsequent reports. Two reviewers will independently assess each article against the selection criteria, extract data on methods and procedures, and assess the methodological quality of each publication. Data will be analysed descriptively.

Fixed-dose combinations of drugs versus single-drug formulations for treating pulmonary tuberculosis.

BACKGROUND: People who are newly diagnosed with pulmonary tuberculosis (TB) typically receive a standard first-line treatment regimen that consists of two months of isoniazid, rifampicin, pyrazinamide, and ethambutol followed by four months of isoniazid and rifampicin. Fixed-dose combinations (FDCs) of these drugs are widely recommended. OBJECTIVES: To compare the efficacy, safety, and acceptability of anti-tuberculosis regimens given as fixed-dose combinations compared to single-drug formulations for treating people with newly diagnosed pulmonary tuberculosis. SEARCH METHODS: We searched the Cochrane Infectious Disease Group Specialized Register; the Cochrane Central Register of Controlled Trials (CENTRAL, published in the Cochrane Library, Issue 11 2015); MEDLINE (1966 to 20 November 2015); EMBASE (1980 to 20 November 2015); LILACS (1982 to 20 November 2015); the metaRegister of Controlled Trials; and the World Health Organization International Clinical Trials Registry Platform (WHO ICTRP), without language restrictions, up to 20 November 2015. SELECTION CRITERIA: Randomized controlled trials that compared the use of FDCs with single-drug formulations in adults (aged 15 years or more) newly diagnosed with pulmonary TB. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for inclusion, and assessed the risk of bias and extracted data from the included trials. We used risk ratios (RRs) for dichotomous data and mean differences (MDs) for continuous data with 95% confidence intervals (CIs). We attempted to assess the effect of treatment for time-to-event measures with hazard ratios and their 95% CIs. We used the Cochrane 'Risk of bias' assessment tool to determine the risk of bias in included trials. We used the fixed-effect model when there was little heterogeneity and the random-effects model with moderate heterogeneity. We used an I² statistic value of 75% or greater to denote significant heterogeneity, in which case we did not perform a meta-analysis. We assessed the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. MAIN RESULTS: We included 13 randomized controlled trials (RCTs) in the review, which enrolled 5824 participants. Trials were published between 1987 and 2015 and included participants in treatment with newly diagnosed pulmonary TB in countries with high TB prevalence. Only two trials reported the HIV status of included participants.Overall there is little or no difference detected between FDCs and single-drug formulations for most outcomes reported. We did not detect a difference in treatment failure between FDCs compared with single-drug formulations (RR 1.28, 95% CI 0.82 to 2.00; 3606 participants, seven trials, moderate quality evidence). Relapse may be more frequent in people treated with FDCs compared to single-drug formulations, although the confidence interval (CI) includes no difference (RR 1.28, 95% CI 1.00 to 1.64; 3621 participants, 10 trials, low quality evidence). We did not detect any difference in death between fixed-dose and single-drug formulation groups (RR 0.96, 95% CI 0.67 to 1.39; 4800 participants, 11 trials, moderate quality evidence).When we compared FDCs with single-drug formulations we found little or no difference for sputum smear or culture conversion at the end of treatment (RR 0.99, 95% CI 0.96 to 1.02; 2319 participants, seven trials, high quality evidence), for serious adverse events (RR 1.45, 95% CI 0.90 to 2.33; 3388 participants, six trials, moderate quality evidence), and for adverse events that led to discontinuation of therapy (RR 0.96, 95% CI 0.56 to 1.66; 5530 participants, 13 trials, low quality evidence).We conducted a sensitivity analysis excluding studies at high risk of bias and this did not alter the review findings. AUTHORS' CONCLUSIONS: Fixed-dose combinations and single-drug formulations probably have similar effects for treating people with newly diagnosed pulmonary TB.

Guía de práctica clínica sobre la detección y el manejo de la enfermedad renal crónica / Clinical practice guideline on the detection and management of chronic kidney disease

Objetivos: Esta GPC sobre Enfermedad Renal Crónica (ERC) responde a preguntas clínicas concernientes a su detección precoz, derivación a atención especializada y manejo, tanto mediante tratamiento farmacológico como con medidas higiénico dietéticas, estilos de vida e intervenciones educativas. Así como informar al paciente y cuidadores para facilitar la toma de decisiones compartidas. En esta GPC no se abordan los siguientes aspectos: Tratamiento de las causas específicas o modificables de ERC, tratamiento sustitutivo renal y tratamiento de las complicaciones de la ERC (anemia, acidosis metabólica, insuficiencia cardiaca, enfermedad renal ósea, insuficiencia renal aguda). ERC en población pediátrica.

Opioids for acute pancreatitis pain.

BACKGROUND: Acute pancreatitis is an acute inflammatory process of the pancreas that may also involve adjacent tissues and/or remote organ systems. Abdominal pain is the main symptom and is usually accompanied by nausea, vomiting and fever. Opoids are commonly used to manage pain in acute pancreatitis but there are still some uncertainties about their clinical effectiveness and safety. OBJECTIVES: To assess the effectiveness and safety of opioids for treating acute pancreatitis pain. SEARCH METHODS: The search strategy included the Cochrane Upper Gastrointestinal and Pancreatic Diseases Review Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library (2013, Issue 6), MEDLINE (from 1950 to June 2013) and EMBASE (from 1980 to June 2013). There were no restrictions by language or publication status. SELECTION CRITERIA: We considered randomised clinical trials (RCTs) assessing the effectiveness of any opioid drug used for treating acute pancreatitis pain. DATA COLLECTION AND ANALYSIS: Two review authors independently selected studies, assessed risks of bias and extracted data. We estimated risk ratios (RRs) for dichotomous data and calculated a 95% confidence interval (CI) for each RR. We performed an intention-to-treat (ITT) analysis. We undertook meta-analysis for some outcomes. MAIN RESULTS: We included five RCTs with a total of 227 participants (age range 23 to 76 years; 65% men) with acute pancreatitis pain. The opioids assessed were intravenous and intramuscular buprenorphine, intramuscular pethidine, intravenous pentazocine, transdermal fentanyl and subcutaneous morphine.One RCT, comparing subcutaneous morphine with intravenous metamizole reported non-significant reduction in the number of participants with improvements in pain intensity (primary outcome) (RR 0.50, 95% CI 0.19 to 1.33). Three studies compared analgesia using opioids with non-opioid treatments. After excluding one study that used opioids through continuous intravenous infusion, there was a decrease in the number of patients requiring supplementary analgesia (RR 0.53, 95% CI 0.30 to 0.93). In a single study, there were no differences in the number of patients requiring supplementary analgesia between buprenorphine and pethidine (RR 0.82, 95% CI 0.61 to 1.10).Pancreatitis complications were not associated with a significant difference between the drugs tested. No clinically serious or life-threatening adverse events occurred related to treatment. No differences for this outcome were found between opioid and non-opioid treatments, or for type of adverse event (nausea-vomiting and somnolence-sedation). One death in the procaine group was reported across all the trials.One RCT comparing pethidine with intramuscular buprenorphine reported non-significant differences of supplementary analgesic, adverse events or deaths. One RCT comparing fentanyl with placebo found no difference in adverse events.The findings of this review are limited by the lack of information to allow full appraisal of the risk of bias, the measurement of relevant outcomes and the small numbers of participants and events covered by the trials. AUTHORS' CONCLUSIONS: Opioids may be an appropriate choice in the treatment of acute pancreatitis pain. Compared with other analgesic options, opioids may decrease the need for supplementary analgesia. There is currently no difference in the risk of pancreatitis complications or clinically serious adverse events between opioids and other analgesia options.Future research should focus on the design of trials with larger samples and the measurement of relevant outcomes for decision-making, such as the number of participants showing reductions in pain intensity. The reporting of these RCTs should also be improved to allow users of the medical literature to appraise their results accurately. Large longitudinal studies are also needed to establish the risk of pancreatitis complications and adverse events related to drugs.

Whole-body vibration training for patients with neurodegenerative disease.

BACKGROUND: Whole-body vibration (WBV) may be a complementary training to standard physical rehabilitation programmes and appears to have potential benefits in the sensorimotor system performance of patients with neurodegenerative diseases. OBJECTIVES: The aim of this review was to examine the efficacy of WBV to improve functional performance according to basic activities of daily living (ADL) in neurodegenerative diseases. Additionally, we wanted to assess the possible effect on signs and symptoms of the disease, body balance, gait, muscle performance, quality of life and adverse events. SEARCH METHODS: We searched the following electronic databases: the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2011 Issue 4), MEDLINE (1964 to 6 May 2011; via PubMed), EMBASE (1980 to 6 May 2011; via Ovid), PeDro (1929 to May 2011; via website), CINAHL (to September 2011; via Ovid) and PsycINFO (1806 to 6 May 2011; via Ovid). SELECTION CRITERIA: We included randomised controlled trials comparing single or multiple sessions of WBV to a passive intervention, any other active physical therapy or WBV with different vibration parameters. DATA COLLECTION AND ANALYSIS: Two review authors independently selected trials for inclusion, assessed trial quality and extracted data. Disagreement was resolved by discussion or, if necessary, referred to a third review author. MAIN RESULTS: We included 10 trials, of which six focused on Parkinson's disease and four on multiple sclerosis. None of the studies reported data on the primary outcome (functional performance). In Parkinson's disease, after pooling two studies, a single session of WBV caused a significant improvement of gait measured using the Timed Up and Go test (TUG) in comparison to standing exercises (mean difference -3.09, 95% confidence interval -5.60 to -0.59; P = 0.02; I(2) = 0%). Nevertheless, longer duration of WBV did not show significant results in comparison with physical therapy in body balance or signs and symptoms measured with the Unified Parkinson's Disease Rating Scale (UPDRS). In multiple sclerosis there was no evidence of a short-term or long-term effect of WBV on body balance, gait, muscle performance or quality of life.Adverse events were reported in few trials. In those trials that reported them, the intervention appeared to be safe. AUTHORS' CONCLUSIONS: There is insufficient evidence of the effect of WBV training on functional performance of neurodegenerative disease patients. Also, there is insufficient evidence regarding its beneficial effects on signs and symptoms of the disease, body balance, gait, muscle strength and quality of life compared to other active physical therapy or passive interventions in Parkinson's disease or multiple sclerosis. More studies assessing other functional tests and accurately assessing safety are needed before a definitive recommendation is established.