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Autism is a neurodevelopmental disorder characterized by alterations in the intellectual, social, communication, and behavioral capabilities of an individual, and is rarely detected in children before 24 months of age. Early diagnosis and intervention may be more effective at a younger age. Functional connectivity magnetic resonance imaging (fcMRI) of 6-month old infants may be able to identify brain connection patterns related to at least one of the characteristics of autism, which normally appear at 24 months of age, by using a mathematical model to analyze the neuroimaging data.
Clinical studies published up to December 2018 that used fcMRI to detect autism in infants were reviewed. The literature databases searched included PubMed, Web of Science, the Trip Database, DynaMed, the Cochrane Library, the International Clinical Trials Registry Platform, and ClinicalTrials.gov. Early assessments of fcMRI analysis were identified through the Early Awareness and Alert System of the Agencia de Evaluación de Tecnologías Sanitarias.
Only one prospective study of 59 infants at 6-months of age was retrieved. A fcMRI analysis was performed to identify 2,635 pairs of functional connections from 230 brain regions. The infants were subsequently assessed for autism at 24 months of age using gold standard tests. The functional connections correlated with at least one of the behaviors related to autism evaluated at 24 months of age. Eleven infants (19%) were diagnosed with autism at 24 months. Compared with the gold standard test results, the predictive model achieved the following: sensitivity 0.82 (95% confidence interval [CI]: 0.52 - 0.95); specificity 1.00 (95% CI: 0.93–1.00); positive predictive value 1.00 (95% CI: 0.70–1.00); negative predictive value 0.96 (95% CI: 0.87–0.99); and negative likelihood ratio 0.18 (95% CI: 0.05–0.64). Adverse effects were not reported in the study.
The fcMRI analysis could help in early detection of autism and the development of preventive interventions. However, the evidence is sparse and more well-designed studies are needed.
Treatment of varicose veins is currently performed by different interventionist alternatives that include surgical, endothermal and non-thermal ablation therapies. The main guidelines recommended endovenous thermal treatment as the first choice therapy; however present side effects related to thermal energy. Non-tumescent endovenous ablation techniques such as cyanoacrylate ablation (CA) started to develop to avoid these problems. The objective of this study is to assess the effectiveness and safety of CA for saphenous vein incompetence.
A systematic review with meta-analysis was carried out. The search of scientific literature was performed in Medline, Embase, Cochrane library, CDR, WoS and Scopus databases. GRADE methodology was used to assess the quality of the evidence and Cochrane risk of bias tool to assess methodological quality of randomized control trials (RCT). Pooled risk ratio was calculated using a random effects model.
Two RCTs and one non-RCT comprising 1,077 participants were included. Additionally, 10 case series were included for safety assessment. Pooled analysis of closure rates by the two RCTs indicated there were not significant differences between CA and radiofrequency ablation (RFA) or endovenous laser ablation (EVLA). Improvements in venous clinical severity score were reported by all comparative studies without significant differences among groups. The most frequently reported adverse events were ecchymosis, phlebitis, paraesthesia, and thrombosis. The pooled analysis showed significant differences only in ecchymosis rates, with lower probability of ecchymosis in CA groups. CA treatment showed lower pain rates and shorter intervention times and recovery compared to endothermal therapies.
The effectiveness of CA devices in the treatment of varicose veins is comparable to EVLA and RFA, while the rates of adverse effects are lower. Despite the limitations of the evidence, CA may be a promising alternative to existing treatments, with the advantages of better patient comfort.
Appropriate involvement of stakeholders is one of the founding principles of the European Cooperation on Health Technology Assessment. The European Network for Health Technology Assessment (EUnetHTA) produces Rapid Relative Effectiveness Assessments (REAs) to assess pharmaceutical (PT) or other technologies (OT). Stakeholders essentially participate in the scoping, the draft assessment phase, or both.
All REAs published since 2013 were reviewed. Stakeholder participation in scoping (project plan) and draft assessment was evaluated. We aggregated categories of stakeholders in four groups (Health Care Providers and Academia, Patients and Consumers, Manufacturers, and Regulators and Payers). Means of collaboration (meetings, comments to project plan and draft assessment, questionnaires, focus groups) are also analyzed. Data is continuously updated with new REAs.
More than 20 REAs have been published at the moment, with a higher number of OT. Health Care Providers and Academia acted as experts in both phases, participating in all REA of OT, and less of PT. Manufacturers participated in all REA in the scoping phase. Regulators and Payers, less involved, participated mainly in the scoping phase. The main methods are providing comments in a standardized form and meetings. Patients' contribution, similar in OT and PT, has increased over the years. Questionnaires or interviews were the main method of involvement, followed by participation in meetings and focus groups. Visibility and transparency have also improved, with a clearer reporting of the stakeholder contribution in the last assessments.
The stakeholder involvement in EUnetHTA REAs is steadily growing, with the different nature of stakeholders’ categories reflected in their contribution to the assessments. EUnetHTA is standardizing stakeholder involvement procedures taking into account the particularities of each group when generating guidance for stakeholder involvement.
Minimally invasive capsulorhexis is an incision in the anterior capsule in the peripheral zone for cataract extraction. It allows reduction of the size of the lesion, ensuring a better transparency of the visual axis, preserving the capsule almost intact and a layer of lenticular epithelial cells. The procedure could have a potential regenerative effect of the lens in a natural way. The objective of this study is to assess the efficacy and safety of minimally invasive capsulorhexis to promote lens regeneration in children's cataracts.
This technology was identified by the early Awareness and Alert System, “SINTESIS-new technologies” of Agencia de Evaluación de Tecnologías Sanitarias (AETS) Instituto de Salud Carlos III (ISCIII). An early assessment was conducted. The searched databases were: PubMed, Centre for Reviews and Dissemination (CRD), and Cochrane Library. Clinical studies using the procedure published in any language until 29 September 2017 were reviewed.
An open-label, randomized trial in pediatric cataract patients (age: 0–2 years) was retrieved. Twelve patients underwent minimally invasive capsulorhexis, while twenty-five patients received the standard treatment. Regarding efficacy, a transparent regenerated biconvex lens was found in 100 percent of eyes three months after surgery, but wasn't found in the control group. 100 percent of capsular openings healed within one month after surgery in the experimental group, but not in the control group. Both groups increased their visual acuity parameters without significant differences. Regarding safety, children receiving the standard technique had a higher incidence of corneal edema (eight percent in the intervention vs thirty percent in the control group), anterior chamber inflammation (seventeen percent vs seventy-four percent), additional laser capsulotomy (zero percent vs eighty-four percent) and increased visual axis opacification (four percent vs eighty-four percent).
Minimally invasive capsulorhexis in children's cataracts seems to be a promising new procedure. Preliminary efficacy results were good and safety profile was better than standard treatment. However, it would be necessary to continue further studies to confirm these results.
Ovarian cancer (OC) has the highest mortality rate of all gynecologic malignancies. Completeness of cytoreductive surgery is a key prognostic factor for survival. To differentiate clearly between malignant and healthy tissue is essential for achieving complete cytoreduction. Using current approaches, this differentiation is difficult and can lead to incomplete tumour removal. OTL38 is a folate analogue conjugated to a near-infrared fluorescent dye which has high specificity and affinity for folate receptor alpha (FRα) expressed in OC. OTL38 together with a specific imaging system can help the surgeon to visualize diseased tissue. The objective of this work is to know the effectiveness and safety of OTL38 in of OC surgery.
Early assessment of OTL38 identified through the early-awareness and alert-system, “SINTESIS-new technologies”, of AETS-ISCIII. The searched databases were: PubMed, WOS, Tripdatabase, Dynamed, Cochrane Library and ICTRP. Clinical studies using the OTL38 in cytoreductive surgery in OC published until September 2017 were reviewed.
Only one publication, supported by industry, was retrieved. The study assesses the pharmacokinetics and tolerability of OLT38 in 30 healthy people randomized into 4 groups with different doses and a control group. The study also analyses the percentage of cytoreduction in 12 OC patients. Infusion of 0.025, 0.05, and 0.1 mg/kg OTL38 doses was associated with mild adverse events which did not require intervention. The 0.2 mg/kg dose was associated to adverse events of moderate severity. In OC patients, 0.0125 mg/kg dose was considered the optimal dose with mild adverse events. OTL38 accumulated in FRα-positive tumours and metastases allowed the surgeon to resect an additional 29 percent of malignant lesions which were not detected using standard inspection and palpation methods.
The OTL38 is an emergent health technology, which could help in cytoreductive surgery for ovarian cancer. However, the evidence is scarce and it would be necessary to continue further studies.
The hypoglossal nerve stimulation (HNS) produces a tongue protrusion for the treatment of mod-severe obstructive sleep apnea (OSA). It is one of the emerging health technologies prioritized to assess its possible inclusion on the Spanish National Health System. The objective of this study is to evaluate the efficacy and safety of this system in the treatment of OSA.
An early assessment (horizon scanning) was performed. The searched databases were: PubMed, WOS, Tripdatabase, Dynamed, Cochrane Library and ICTRP. Clinical studies of OSA patients treated with HNS published until 01 March 2017 were reviewed. Outcomes considered were: AHI (Apnea Hypopnea Index) ODI (Oxygen Desaturation Index) ESS (Epworth sleepiness scale) and AE (adverse events).
Four devices of HNS were founded: Inspire™, HGNS®, Aura6000™, and Nixoah™. We found two randomized controlled trials (RCT). The Inspire™ RCT showed significant results on mean differences on AHI (−16.9, 95% CI −24.7 to −9.0); ODI (−15.1, 95% CI −22.7 to −7.5) and ESS (−4.5, 95% CI −7.5 to −1.4) in 46 patients, after one week of follow-up. The HGNS® RCT showed non-significant differences on AHI (device active 22.1 ± 5.2 vs control 29.7 ± 6.2), ODI (11.4 ± 4.1 vs 19.5 ± 5.2) and ESS (9.8 ± 1.0 vs 14.1 ± 2.5) in 21 patients at 6 months. A systematic review that included 6 cases series (3 with HGNS®, 2 with Inspire™ and 1 with Aura6000™) without device subgroup analysis and 7 cohorts studies (6 with Inspire™ and one with Aura6000™) showed significant differences comparing AHI, ODI and ESS results to before treatment values. Major AE reported from the studies varied from 4 to 4.5%. No study with Nixoah™ was found.
Inspire™ seems to be an effective option for OSA patients although the evidence is scarce and of low quality for all HNS devices. It would be necessary further well-designed studies.
Alzheimer's disease (AD) is the most common type of dementia. Plasmapheresis is a procedure consisting of removing the plasma, or specific elements which are considered to be involved in pathological processes. Plasmapheresis could reduce the A beta peptides load in the brain. The objective is to study the safety and efficacy of plasmapheresis for AD.
Systematic review, with all studies published before April 2016 reviewed. Selected studies included patients with AD treated with plasmapheresis. GRADE was used to assess quality. Efficacy outcomes include: (i) Cognitive, functional and behavior status, through Mini Mental State Examination, and Alzheimer Disease Assessment Scale-Cognitive test; (ii) Plasma and cerebrospinal fluid A beta levels; (iii) Brain-imaging and functional neuroimaging studies. Safety outcomes included side effects related to the treatment.
Two papers reporting results from three studies were selected: (i) pilot study (n = 10), (ii) its extended study (12 months more of follow-up) (n = 7), and (iii) clinical trial (n = 39). The quality of evidence was very low. About efficacy, the studies didn't report quantitative results and were inconclusive. The pilot study and its extended study reported (1): a tendency towards stabilization in cognitive status; the plasma levels of A beta peptides didn't show a clear pattern; and the brain-imaging assessment suggested a progressive volume increase in the hippocampus. The clinical trial reported in the experimental group vs control (2): a better score for the cognitive status; an increase of plasma A beta peptides; and did not find significant differences between groups for cerebrospinal fluid A beta peptides. The brain-imaging assessment showed a progressive loss of hippocampus volume in both groups. Regarding safety, the studies didn't report quantitative data. We didn't find economic evaluation studies.
The included studies had very high risk of bias and very low quality. We found no evidence on efficacy and safety of plasmapheresis treating AD. Plasmapheresis isn't a priority line in research of AD treatment.
Ischaemic heart disease is the leading cause of death worldwide. Magmaris™ is a new drug-eluting resorbable stent used for coronary reperfusion during a balloon angioplasty. Magmaris™ is composed of absorbable magnesium scaffold and its surface is coated with bioresorbable poly-L-lactide, which incorporates Sirolimus. Magmaris™ has theoretical advantages as the stent body disappears after vascular constrictive remodeling. It would provide the stability and elasticity of non-resorbable metal stents, but without long-term problems such as endothelial dysfunction, delay in endothelialization, risk of thrombosis and complications due to long-term antiplatelet medication. The objective of this work is to assess efficacy and safety of Magmaris ™ in patients with angina or silent ischaemia.
Early assessment of Magmaris™ identified through the Early-Awareness and Alert-System, “SINTESIS-new technologies”, of The Instituto De Salud Carlos III (AETS-ISCIII). The searched databases were: MEDLINE (PubMed), EMBASE, WOS, Clinical Trials and Cochrane Library. Clinical studies using Magmaris™ published in any language until December 2016 were reviewed.
One prospective, non-randomized, non-controlled, multicenter, clinical trial with two publications was retrieved. The first publication (123 patients) showed mainly imaging outcomes of angiography, intravascular ultrasound and tomography at 6 months of follow up. The second publication (118 patients) with data from 12 months of follow up also reported: Target lesion failure in four patients (3.4 percent; 95 percent Confidence Interval, CI:0.9–8.4); one target-vessel myocardial infarction (0.8 percent; one myocardial infarction (0.8 percent); two clinically driven target lesion revascularisation (1.7 percent) and two clinically driven target-vessel revascularisation (1.7 percent). No definite scaffold thrombosis was observed. No procedural complications were reported. This trial is expected to continue up to 36 months of follow up.
Clinical data show that Magmaris™ seems to be an effective and safe treatment in patients with angina or silent ischaemia undergoing balloon angioplasty. More research specially randomized controlled trials are necessary to confirm these results.
Conventional gastric balloons for weight loss require endoscopy for placement and removal. The ELIPSETM is a new gastric balloon designed for weight loss that is swallowed and does not require endoscopy or anesthesia. The device is designed to remain in the stomach and be expelled after a predetermined time of 4 months. The objective of this work is to assess the efficacy and safety of the ELIPSETM procedureless gastric balloon for weight loss.
The ELIPSETM procedureless gastric balloon was identified by the early Awareness and Alert System, “SINTESIS-new technologies,” of The Instituto De Salud Carlos III (AETS-ISCIII). An early assessment of the technology was conducted. The searched databases were: MEDLINE (PubMed), Centre for Reviews and Dissemination, and the Cochrane Library. Clinical studies using the device published in any language until 10 January 2017 were reviewed.
A prospective, non-randomized, open label study supported by industry was retrieved. Thirty-four patients were enrolled. Six patients treated with an experimental device were excluded. Twenty-eight patients successfully swallowed the device. No endoscopy or anesthesia was required. All devices were excreted safely. Of the twenty-five patients finally studied, the mean percent total body weight loss was 10 percent (95 percent Confidence Interval, CI 7.3–12.7) and the mean waist circumference was reduced by 8.4cm (95 percent CI 5.7-11.8) at 4 months. Improvements were also seen in metabolic parameters (HbA1c, Low density lipoprotein, triglycerides and blood pressure). All aspects of quality of life measured by the Impact of Weight on Quality of Life (IWQoL) questionnaire demonstrated significant improvements. About safety, there were no serious adverse events or serious adverse device effects, however 64 percent of patients had vomiting, 54 percent experienced nausea, 25 percent had abdominal pain and 2 patients were excluded because of symptoms.
The ELIPSETM gastric balloon for weight loss seems to be an effective therapy with an acceptable safety profile. However it would be necessary to continue further studies to confirm these results, including comparative studies with current treatments.
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