Randomized
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Antineutrophil cytoplasmic antibody (ANCA)-positive renal vasculitis is the most common cause of rapidly progressive (crescentic) glomerulonephritis. Its life-threatening natural course may be modified substantially by current treatment modalities. The European Vasculitis Study Group (EUVAS) developed a subclassification of ANCA-positive vasculitides based on the disease severity at presentation, and have organized (so far) two waves of clinical trials. The first wave of randomized clinical trials had the aim of optimizing the existing therapeutic regimens; the second wave concentrated on testing some newer therapeutic approaches. Here, the design and available results of the first wave and the design of some second wave trials are reviewed briefly. The potential of the new targeted approaches (e.g. anti-tumour necrosis factor therapy) is also briefly mentioned.
- MeSH
- glomerulonefritida komplikace diagnóza terapie MeSH
- imunosupresiva aplikace a dávkování MeSH
- kombinovaná terapie MeSH
- lidé MeSH
- plazmaferéza metody MeSH
- prognóza MeSH
- protilátky proti cytoplazmě neutrofilů analýza MeSH
- randomizované kontrolované studie jako téma MeSH
- stupeň závažnosti nemoci MeSH
- vaskulitida komplikace diagnóza terapie MeSH
- výsledek terapie MeSH
- Check Tag
- lidé MeSH
- mužské pohlaví MeSH
- ženské pohlaví MeSH
- Publikační typ
- časopisecké články MeSH
- přehledy MeSH
- Geografické názvy
- Evropa MeSH
- Názvy látek
- imunosupresiva MeSH
- protilátky proti cytoplazmě neutrofilů MeSH
Extracorporeal cardiopulmonary resuscitation is a promising treatment for refractory out-of-hospital cardiac arrest. Three recent randomized trials (ARREST trial, Prague OHCA study, and INCEPTION trial) that addressed the clinical benefit of extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest yielded seemingly diverging results. The evidence for extracorporeal cardiopulmonary resuscitation in out-of-hospital cardiac arrest, derived from three recent randomized controlled trials, is not contradictory but rather complementary. Excellent results can be achieved with a very high level of dedication, provided that strict selection criteria are applied. However, pragmatic implementation of extracorporeal cardiopulmonary resuscitation does not necessarily lead to improved outcome of refractory out-of-hospital cardiac arrest. Centres that are performing extracorporeal cardiopulmonary resuscitation for out-of-hospital cardiac arrest or aspire to do so should critically evaluate whether they are able to meet the pre-requisites that are needed to conduct an effective extracorporeal cardiopulmonary resuscitation programme.
- Klíčová slova
- Efficacy and effectiveness, Extracorporeal cardiopulmonary resuscitation, Randomized controlled trials, Review,
- MeSH
- kardiopulmonální resuscitace * MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- zástava srdce mimo nemocnici * terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- randomizované kontrolované studie MeSH
Despite recent improvements in surgical technique, the morbidity of distal pancreatectomy remains high, with pancreatic fistula being the most significant postoperative complication. A systematic review of randomized controlled trials (RCTs) dealing with surgical techniques in distal pancreatectomy was carried out to summarize up-to-date knowledge on this topic. The Cochrane Central Registry of Controlled Trials, Embase, Web of Science, and Pubmed were searched for relevant articles published from 1990 to December 2013. Ten RCTs were identified and included in the systematic review, with a total of 1286 patients being randomized (samples ranging from 41 to 450). The reviewers were in agreement for application of the eligibility criteria for study selection. It was not possible to carry out meta-analysis of these studies because of the heterogeneity of surgical techniques and approaches, such as varying methods of pancreas transection, reinforcement of the stump with seromuscular patch or pancreaticoenteric anastomosis, sealing with fibrin sealants and pancreatic stent placement. Management of the pancreatic remnant after distal pancreatectomy is still a matter of debate. The results of this systematic review are possibly biased by methodological problems in some of the included studies. New well designed and carefully conducted RCTs must be performed to establish the optimal strategy for pancreatic remnant management after distal pancreatectomy.
This study aimed to perform a systematic review and meta-analysis of randomized controlled trials (RCTs) in order to calculate the effect size of statin therapy in changing plasma cortisol concentrations. Following a systematic search in Medline, SCOPUS, Web of Science and Google Scholar databases (by up to March 01, 2015), 7 eligible RCTs were selected. Random-effects meta-analysis suggested a significant increase in plasma cortisol concentrations following statin therapy (WMD: 6.34%, 95% CI: 1.80, 10.87, p=0.006). Subgroup analysis confirmed the significance of the effect with lipophilic statins comprising atorvastatin, simvastatin, and lovastatin (WMD: 7.00%, 95% CI: 2.21, 11.79, p=0.004) but not with hydrophilic statins (rosuvastatin and pravastatin) (WMD: 0.60%, 95% CI: -13.46, 14.66, p=0.933). In the meta-regression analysis, changes in plasma cortisol concentrations following statin therapy were found to be independent of treatment duration. Results of this meta-analysis of RCTs suggest a significant elevation in plasma cortisol levels following statin therapy.
- Klíčová slova
- Cortisol level, Meta-analysis, Randomized controlled trial, Statin,
- MeSH
- hydrokortison krev MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- statiny farmakologie terapeutické užití MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- metaanalýza MeSH
- přehledy MeSH
- systematický přehled MeSH
- Názvy látek
- hydrokortison MeSH
- statiny MeSH
BACKGROUND: Randomized controlled trials (RCTs) are the best tool to evaluate the effectiveness of clinical interventions. The CONSORT (Consolidated Standards of Reporting Trials) statement is an evidence-based approach to improve the quality of RCTs reporting. OBJECTIVE: To evaluate the reporting quality of published RCTs concerning multiple sclerosis from 2000 to 2015 according to a checklist based on the CONSORT statement. METHODS: Electronic databases were searched for English-language RCTs involving patients with multiple sclerosis (MS). Trials were considered eligible when participants were randomly assigned to at least two medicinal treatment arms and included patients with MS. Quality of reporting was assessed using a 39-item questionnaire based on the CONSORT checklist. Articles were grouped in three 5-year periods and comparisons were made using descriptive statistics. RESULTS AND CONCLUSION: The search identified 102 eligible articles for analysis. 20 of the 38 items of the checklist (52.6%) were addressed in 75% or more of the studies. Reporting of more than 75% of CONSORT items (>75% CONSORT compliance) was increased during the three five-year time periods from 2000 to 2015 (p<0.05). CONCLUSIONS: Quality of reporting in RCTs focusing on multiple sclerosis is showing improvement over time, but still remains unsatisfactory. Further improvement of reporting is necessary to assess the validity of clinical research.
- Klíčová slova
- CONSORT, Multiple sclerosis, Randomized controlled trials,
- MeSH
- impakt faktor časopisů MeSH
- lidé MeSH
- periodika jako téma MeSH
- publikování normy MeSH
- randomizované kontrolované studie jako téma normy MeSH
- roztroušená skleróza terapie MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
BACKGROUND: Sedation is often provided to resuscitated out-of-hospital cardiac arrest (OHCA) patients to tolerate post-cardiac arrest care, including temperature management. However, the evidence of benefit or harm from routinely administered deep sedation after cardiac arrest is limited. The aim of this trial is to investigate the effects of continuous deep sedation compared to minimal sedation on patient-important outcomes in resuscitated OHCA patients in a large clinical trial. METHODS: The SED-CARE trial is part of the 2 × 2 × 2 factorial Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, a randomized international, multicentre, parallel-group, investigator-initiated, superiority trial with three simultaneous intervention arms. In the SED-CARE trial, adults with sustained return of spontaneous circulation (ROSC) who are comatose following resuscitation from OHCA will be randomized within 4 hours to continuous deep sedation (Richmond agitation and sedation scale (RASS) -4/-5) (intervention) or minimal sedation (RASS 0 to -2) (comparator), for 36 h after ROSC. The primary outcome will be all-cause mortality at 6 months after randomization. The two other components of the STEPCARE trial evaluate sedation and temperature control strategies. Apart from the STEPCARE trial interventions, all other aspects of general intensive care will be according to the local practices of the participating site. Neurological prognostication will be performed according to European Resuscitation Council and European Society of Intensive Care Medicine guidelines by a physician blinded to the allocation group. To detect an absolute risk reduction of 5.6% with an alpha of 0.05, 90% power, 3500 participants will be enrolled. The secondary outcomes will be the proportion of participants with poor functional outcomes 6 months after randomization, serious adverse events in the intensive care unit, and patient-reported overall health status 6 months after randomization. CONCLUSION: The SED-CARE trial will investigate if continuous deep sedation (RASS -4/-5) for 36 h confers a mortality benefit compared to minimal sedation (RASS 0 to -2) after cardiac arrest.
- Klíčová slova
- cardiac arrest, randomized clinical trial, sedation,
- MeSH
- analgosedace * metody MeSH
- dospělí MeSH
- hluboká sedace * metody MeSH
- kardiopulmonální resuscitace * metody MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- zástava srdce mimo nemocnici * terapie mortalita MeSH
- Check Tag
- dospělí MeSH
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- protokol klinické studie MeSH
- srovnávací studie MeSH
Subsequent to EMA approval of tetrahydrocannabinol (THC): cannabidiol (CBD) oromucosal spray based on results of various studies, including an enriched-design clinical trial, two newer postapproval randomized trials have confirmed its efficacy and safety for treating resistant multiple sclerosis spasticity, while simultaneously addressing specific authorities' concerns. A double-blind, placebo-controlled, Phase IV trial, conducted as part of the EMA's risk management plan, found no effect of THC:CBD spray on cognition and mood after 50 weeks of treatment. In the Sativex® as add-on therapy versus further optimized first-line ANTispastics (SAVANT) study, add-on THC:CBD spray was significantly more effective than readjusting standard antispasticity therapy and provided new evidence of efficacy as requested by German authorities. SAVANT results support practical recommendations for treating resistant multiple sclerosis spasticity in daily practice.
- Klíčová slova
- THC:CBD oromucosal spray, cognition, mood, multiple sclerosis spasticity, randomized controlled trials, treatment optimization,
- MeSH
- afekt účinky léků MeSH
- aplikace slizniční MeSH
- fixní kombinace léků MeSH
- kanabidiol aplikace a dávkování farmakologie MeSH
- kognice účinky léků MeSH
- lidé MeSH
- modulátory kanabinoidních receptorů aplikace a dávkování farmakologie MeSH
- randomizované kontrolované studie jako téma * MeSH
- roztroušená skleróza komplikace farmakoterapie MeSH
- svalová spasticita farmakoterapie etiologie MeSH
- tetrahydrokanabinol aplikace a dávkování farmakologie MeSH
- ústní spreje MeSH
- výsledky a postupy - zhodnocení (zdravotní péče) * MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- Názvy látek
- fixní kombinace léků MeSH
- kanabidiol MeSH
- modulátory kanabinoidních receptorů MeSH
- nabiximols MeSH Prohlížeč
- tetrahydrokanabinol MeSH
- ústní spreje MeSH
BACKGROUND: Music therapy is a promising approach widening the potential applications of psychotherapy. Music influences both, psychologic and physiologic parameters, and children are especially responsive to this form of therapy. Many aspects of its action mechanisms remain to be elucidated, underscoring the need for evidence-based medicine (EBM) for clinical use of music therapy. AIMS: This review seeks to highlight some of the issues of music therapy research and to initiate a discussion about the need for international multicenter cooperation to bring scientifically sound evidence of the benefits of music therapy in pediatric patients. METHODS: Scientific bibliographic databases were searched for randomized controlled trials on use of music therapy for children. Identified articles were evaluated according to criteria for scientific quality. RESULTS: Twenty-eight studies were identified. Most of the trials were biased by the number of participants, and some trials showed the need to improve design of control groups. Indeed, the novelty of this area of study has produced a large number of different studies (with variability in diagnoses, interventions, control groups, duration, and/or outcome parameters), and there is a need for a more homogeneous and systematic approach. Available studies highlight the need to address reproducibility issues. CONCLUSIONS: This analysis identifies the need for a subsequent series of clinical studies on the efficacy of music in the pediatric population, with more focus on eligibility criteria with respect to EBM and reproducibility.
BACKGROUND: Growing numbers of randomized controlled trials (RCTs) are showing the effectiveness of interventions to improve medication adherence in transplantation recipients. However, real-world implementation is still a major challenge. This systematic review assesses the range of information available in RCTs supporting these interventions' clinical adoption in adult transplant populations. METHODS: We included RCTs of interventions that a) targeted any phase of medication adherence in solid organ or allogeneic stem cell transplantation recipients and b) were published between January 2015 and November 2020. We excluded study protocols, conference abstracts and studies focusing only on pediatric populations. We identified relevant database and trial registries as well as traced references backward and citations forward. Implementation-relevant information was evaluated using adapted versions of Peters' ten criteria: 1. healthcare/organizational context; 2. social/economic/policy context; 3. patient involvement; 4. other stakeholder involvement; 5. sample representativeness; 6. trial conducted in a real-world-setting; 7. presence of feasibility study; 8. implementation strategy; 9. process evaluation; 10. implementation outcomes, using a stoplight color-rating system. RESULTS: Screening 17'004 titles/abstracts resulted in 23 eligible RCTs, including 2'339 patients (n = 19-209/study). All included studies focused on the implementation phase of medication adherence. The best-reported criteria were feasibility study (43%), representative sample (17%) and conducted in a real-world-setting (17%). Least reported were context (9%), implementation strategies (4%), process evaluation (4%). CONCLUSIONS: RCTs testing medication adherence interventions tend to report limited implementation-relevant information. This hinders their translation to real-world transplant settings. Integrating implementation science principles early in the conceptualization of RCTs would fuel real-world-translation, reducing research waste.
- Klíčová slova
- Allogeneic stem cell transplantation, Implementation science, Medication adherence, Peters' criteria, Randomized controlled trials, Solid organ transplantation,
- MeSH
- adherence k farmakoterapii * MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
- přehledy MeSH
- systematický přehled MeSH
JBI recently began the process of updating and revising its suite of critical appraisal tools to ensure that these tools remain compatible with recent developments within risk of bias science. Following a rigorous development process led by the JBI Effectiveness Methodology Group, this paper presents the revised critical appraisal tool for the assessment of risk of bias for randomized controlled trials. This paper also presents practical guidance on how the questions of this tool are to be interpreted and applied by systematic reviewers, while providing topical examples. We also discuss the major changes made to this tool compared to the previous version and justification for why these changes facilitate best-practice methodologies in this field.
- MeSH
- lidé MeSH
- randomizované kontrolované studie jako téma * MeSH
- zkreslení výsledků (epidemiologie) MeSH
- Check Tag
- lidé MeSH
- Publikační typ
- časopisecké články MeSH
- práce podpořená grantem MeSH
