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
- Glomerulonephritis complications diagnosis therapy MeSH
- Immunosuppressive Agents administration & dosage MeSH
- Combined Modality Therapy MeSH
- Humans MeSH
- Plasmapheresis methods MeSH
- Prognosis MeSH
- Antibodies, Antineutrophil Cytoplasmic analysis MeSH
- Randomized Controlled Trials as Topic MeSH
- Severity of Illness Index MeSH
- Vasculitis complications diagnosis therapy MeSH
- Treatment Outcome MeSH
- Check Tag
- Humans MeSH
- Male MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Review MeSH
- Geographicals
- Europe MeSH
- Names of Substances
- Immunosuppressive Agents MeSH
- Antibodies, Antineutrophil Cytoplasmic 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.
- Keywords
- Efficacy and effectiveness, Extracorporeal cardiopulmonary resuscitation, Randomized controlled trials, Review,
- MeSH
- Cardiopulmonary Resuscitation * MeSH
- Humans MeSH
- Randomized Controlled Trials as Topic MeSH
- Out-of-Hospital Cardiac Arrest * therapy MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Randomized Controlled Trial 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.
- Keywords
- CONSORT, Multiple sclerosis, Randomized controlled trials,
- MeSH
- Journal Impact Factor MeSH
- Humans MeSH
- Periodicals as Topic MeSH
- Publishing standards MeSH
- Randomized Controlled Trials as Topic standards MeSH
- Multiple Sclerosis therapy MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article 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.
- MeSH
- Child MeSH
- Humans MeSH
- Music Therapy * methods MeSH
- Pediatrics methods MeSH
- Randomized Controlled Trials as Topic MeSH
- Check Tag
- Child MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Systematic Review MeSH
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.
- Keywords
- Cortisol level, Meta-analysis, Randomized controlled trial, Statin,
- MeSH
- Hydrocortisone blood MeSH
- Humans MeSH
- Randomized Controlled Trials as Topic MeSH
- Hydroxymethylglutaryl-CoA Reductase Inhibitors pharmacology therapeutic use MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Meta-Analysis MeSH
- Systematic Review MeSH
- Names of Substances
- Hydrocortisone MeSH
- Hydroxymethylglutaryl-CoA Reductase Inhibitors MeSH
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.
- Keywords
- Allogeneic stem cell transplantation, Implementation science, Medication adherence, Peters' criteria, Randomized controlled trials, Solid organ transplantation,
- MeSH
- Medication Adherence * MeSH
- Humans MeSH
- Randomized Controlled Trials as Topic MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
- Systematic Review 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
- Humans MeSH
- Randomized Controlled Trials as Topic * MeSH
- Bias MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Research Support, Non-U.S. Gov't MeSH
OBJECTIVES: To assess the impact of rehabilitation in ICU on clinical outcomes. DATA SOURCES: Secondary data analysis of randomized controlled trials published between 1998 and October 2019 was performed in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. STUDY SELECTION: We have selected trials investigating neuromuscular electrical stimulation or cycling exercises or protocolized physical rehabilitation as compared to standard of care in critically ill adults. DATA EXTRACTION: Mortality, length of stay in ICU and at hospital, days on mechanical ventilator, and adverse events. DATA SYNTHESIS: We found 43 randomized controlled trials (nine on cycling, 14 on neuromuscular electrical stimulation alone and 20 on protocolized physical rehabilitation) into which 3,548 patients were randomized and none of whom experienced an intervention-related serious adverse event. The exercise interventions had no influence on mortality (odds ratio 0.94 [0.79-1.12], n = 38 randomized controlled trials) but reduced duration of mechanical ventilation (mean difference, -1.7 d [-2.5 to -0.8 d], n = 32, length of stay in ICU (-1.2 d [-2.5 to 0.0 d], n = 32) but not at hospital (-1.6 [-4.3 to 1.2 d], n = 23). The effects on the length of mechanical ventilation and ICU stay were only significant for the protocolized physical rehabilitation subgroup and enhanced in patients with longer ICU stay and lower Acute Physiology and Chronic Health Evaluation II scores. There was no benefit of early start of the intervention. It is likely that the dose of rehabilitation delivered was much lower than dictated by the protocol in many randomized controlled trials and negative results may reflect the failure to implement the intervention. CONCLUSIONS: Rehabilitation interventions in critically ill patients do not influence mortality and are safe. Protocolized physical rehabilitation significantly shortens time spent on mechanical ventilation and in ICU, but this does not consistently translate into long-term functional benefit. Stable patients with lower Acute Physiology and Chronic Health Evaluation II at admission (<20) and prone to protracted ICU stay may benefit most from rehabilitation interventions.
CONTEXT: Carbohydrate-restricted diets are widely used as an effective treatment tool for many chronic diseases. The impact of these diets on physical health is well known, but their impact on psychological health is less well described in the scientific literature. This is an important aspect to focus on, especially if the diets are to be sustainable in the long term. OBJECTIVE: The objective of this study was to systematically review the scientific literature describing the effect of carbohydrate-restricted diets and ketogenic diets on psychological outcomes, as observed in randomized controlled trials. Additionally, the potential synergistic effect of carbohydrate-restricted diets and exercise or social factors on these outcomes was researched. DATA SOURCES: Five databases (Web of Science, PubMed, Scopus, ScienceDirect, and MEDLINE Complete) were searched without restriction of publication date. DATA EXTRACTION: The first data extraction was made in October 2020 and the second in May 2022. Abstract screening was performed by 3 independent reviewers. The quality of studies was assessed using the Jadad scale. DATA ANALYSIS: Sixteen randomized controlled studies were included in the analysis. Five studies focused on clinical populations, 9 on obese/overweight populations, and 2 on healthy populations; all studies examined adult people. Four psychological outcomes were identified (quality of life, mental health, mood, and fatigue), and they were examined in connection with a very low-carbohydrate or ketogenic diet. CONCLUSION: Daily low-carbohydrate intake may not negatively affect psychological well-being, and low-carbohydrate diets and ketogenic diets are no worse than other diets in this respect. An intervention of 12 weeks or longer can bring benefits in psychological well-being. The synergistic effect of diet and exercise or social factors was not reviewed due to lack of evidence.
- Keywords
- fatigue, ketogenic diet, mental health, mood, quality of life, very low-carbohydrate high-fat diet,
- MeSH
- Diet, Carbohydrate-Restricted * methods MeSH
- Adult MeSH
- Quality of Life * MeSH
- Humans MeSH
- Obesity MeSH
- Randomized Controlled Trials as Topic MeSH
- Carbohydrates MeSH
- Check Tag
- Adult MeSH
- Humans MeSH
- Publication type
- Journal Article MeSH
- Systematic Review MeSH
- Names of Substances
- Carbohydrates MeSH
BACKGROUND AND PURPOSE: After numerous attempts to prove efficacy for endovascular treatment of ischemic stroke, a series of recent randomized controlled clinical trials (RCTs) established fast mechanical thrombectomy (MT) as a safe and effective novel treatment for emergent large vessel occlusion (ELVO) in the anterior cerebral circulation. METHODS: We reviewed five recent RCTs that evaluated the safety and efficacy of MT in ELVO patients and captured available information on recanalization/reperfusion, symptomatic intracranial hemorrhage (sICH), clinical outcome, and mortality. MT was performed with stent retrievers, aspiration techniques, or a combination of these endovascular approaches. We applied meta-analytical methodology to evaluate the pooled effect of MT on recanalization/reperfusion, sICH, functional independence (modified Rankin scale score of 0-2) and 3-month mortality rates in comparison to best medical therapy (BMT). RESULTS: MT was associated with increased likelihood of complete recanalization/reperfusion (RR: 2.22; 95%CI: 1.89-2.62; P < 0.00001) and 3-month functional independence (RR: 1.72; 95%CI: 1.48-1.99; P < 0.00001) without any heterogeneity across trials (I (2) = 0%). The absolute benefit increase in MT for complete recanalization/reperfusion and functional independence was 44 (NNT = 2) and 16 (NNT = 6), respectively. MT was not associated with increased risk of 3-month mortality (15% with MT vs. 19% with BMT) and sICH (4.6% with MT vs. 4.3% with BMT), while small heterogeneity was detected across the included trials (I (2) < 25%). CONCLUSIONS: MT is a safe and highly effective treatment for patients with ELVO in the anterior circulation. For every six ELVO patients treated with MT three more will achieve complete recanalization at 24 h following symptom onset and one more will be functionally independent at 3 months in comparison to BMT.
- Keywords
- Endovascular treatment, intravenous thrombolysis, ischemic stroke, recanalization, thrombectomy,
- MeSH
- Stroke therapy MeSH
- Brain Ischemia therapy MeSH
- Humans MeSH
- Mechanical Thrombolysis * adverse effects MeSH
- Randomized Controlled Trials as Topic MeSH
- Check Tag
- Humans MeSH
- Publication type
- Journal Article MeSH
- Meta-Analysis MeSH
- Research Support, Non-U.S. Gov't MeSH
- Review MeSH
