Extracorporeal Cytokine Adsorption Therapy As a Preventive Measure in Cardiac Surgery and As a Therapeutic Add-On Treatment in Sepsis: An Updated Systematic Review of Comparative Efficacy and Safety.

OBJECTIVES: Evaluating whether there is a clinical benefit of using extracorporeal cytokine adsorption therapy in two indications. DESIGN: Systematic review. SETTING: Search on four databases, Medline, Embase, The Cochrane Library, and the European Network for Health Technology Assessment planned and ongoing projects database. PATIENTS: Patients with sepsis/septic shock; patients undergoing cardiac surgery. INTERVENTIONS: Cytokine adsorption. MEASUREMENTS AND MAIN RESULTS: Randomized controlled trials and prospective studies with concurrent control were eligible for the evidence synthesis. The quality of the individual studies and the strength of the available evidence were assessed using the Cochrane risk of bias tool and the Grading of Recommendations, Assessment, Development, and Evaluation approach, respectively. For the preventive treatment of extracorporeal cytokine adsorption therapy in patients undergoing cardiac surgery, we found very low-quality inconclusive evidence for mortality (five randomized controlled trials, n = 163), length of stay in the ICU (five randomized controlled trials, n = 163), and length of hospitalization (three randomized controlled trials, n = 101). Very low-quality inconclusive evidence was found for (serious) adverse events (four randomized controlled trials, n = 148). For the therapeutic treatment of extracorporeal cytokine adsorption therapy in patients with sepsis/septic shock, we found very low-quality inconclusive evidence for mortality up to 60-day follow-up (two randomized controlled trials, n = 117), organ function (two randomized controlled trials, n = 117) and length of stay in the ICU (one randomized controlled trial, n = 20). Very low-quality inconclusive evidence was found for (serious) adverse events (two randomized controlled trials, n = 117). CONCLUSIONS: Given the available evidence, the efficacy and safety of extracorporeal cytokine adsorption therapy in combination with standard care in the investigated indications was not established. We strongly recommend considering well-powered studies with patient-relevant endpoints instead of investing further research funds on studies that may not shed light on the clinical benefit of extracorporeal cytokine adsorption therapy.

Decision-making at the limit of viability: the Austrian neonatal choice context.

BACKGROUND: We aimed to explore the shared decision-making context at the limit of viability (weeks 22-25 of gestation) through analyzing neonatologist's communication strategies with parents and their possible impact on survival and neurodevelopmental impairment (NDI) outcomes. METHODS: A mixed methods approach was applied where a systematic literature search and in-depth semi-structured interviews with five heads of neonatology departments and one clinical ethicist from the Austrian context were integrated into a literature review. The aim was to identify decision practice models and the choice context specific to Austria. RESULTS: Professional biases, parental understanding, and the process of information giving were identified as aspects possibly influencing survival and NDI outcomes. Institutions create self-fulfilling prophecies by recommending intensive/palliative care based upon their institutional statistics, yet those vary considerably among high-income countries. Labelling an extremely preterm (EP) infant by the gestational week was shown to skew the estimates for survival while the process of information giving was shown to be subject to framing effect and other cognitive biases. CONCLUSION: Communication strategies of choice options to parents may have an impact on the way parents decide and hence also on the outcomes of EP infants.

Efficacy Assessment of Radiofrequency Ablation as a Palliative Pain Treatment in Patients with Painful Metastatic Spinal Lesions: A Systematic Review.

BACKGROUND: Metastatic spinal lesions are difficult-to-treat entities that are most commonly associated with pain and severely reduced health-related quality of life (HRQoL). Within the last 5 to 10 years, radiofrequency ablation (RFA) has emerged as an option in the palliative treatment of vertebral metastases. OBJECTIVES: Our review aims to evaluate the clinical effectiveness and safety of RFA, mostly in combination with vertebroplasty, in patients with painful vertebral metastases. STUDY DESIGN: The design of this study is a systematic review. METHODS: We conducted a systematic literature search and a manual search of 5 databases in December 2016. The review applied a methodological framework based on the HTA Core Model®. Data on each selected outcome category were synthesized according to the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) scheme. Risk of bias was assessed using the Institute of Health Economics (IHE) Risk of Bias checklist for case series. RESULTS: We identified 299 citations. After applying the inclusion criteria, a total of 9 studies (4 prospective and 5 retrospective studies) were determined to be eligible. These studies included a total of 583 patients with vertebral metastases who were treated with RFA and, in most cases, received an additional vertebroplasty treatment (n = 437). The studies were categorized as having a moderate to high risk of bias. The strength of evidence was found to be "very low" for safety outcomes and could not be assessed for efficacy outcomes. Current evidence suggests that RFA leads to significant pain reduction. Furthermore, no major complications occurred when using RFA. LIMITATIONS: A major concern is the low number of included patients and heterogeneity of study characteristics in most of the studies. The low number of patients also impeded comparison of the effectiveness of RFA alone to RFA in combination with vertebroplasty. CONCLUSION: According to the available evidence, RFA may be safe and effective, especially for patients with painful vertebral metastases who show contraindications or unresponsiveness to conventional therapies (e.g., radiation) or for those who are at risk of tumor progression. KEY WORDS: Radiofrequency ablation, vertebral metastases, metastatic spinal lesions, pain, clinical effectiveness, safety, palliative pain treatment.

Novel Surgical Treatments for Gastroesophageal Reflux Disease: Systematic Review of Magnetic Sphincter Augmentation and Electric Stimulation Therapy.

Electric stimulation therapy (EST) and magnetic sphincter augmentation (MSA) represent novel methods for the surgical treatment of gastroesophageal reflux disease (GERD). The aim of this review was to assess the effectiveness and safety of EST and magnetic sphincter augmentation device (MSAD) comapred to laparoscopic fundoplication (LF) and proton pump inhibitor therapy (in case of EST). We performed a systematic literature search without restrictions on publication dates in five electronic databases (MEDLINE, EMBASE, the Cochrane library, PubMed, and Centre for Reviews and Dissemination), complemented by hand search, search in trial registries, and documentation provided by the manufacturers. No study passed inclusion criteria for analyzing EST effectiveness. Concerning safety, lead erosion through the esophagus and trocar perforation of the small bowel occurred in 2.4% of patients (in one study). Only the registry study fulfilled inclusion criteria for effectiveness analysis of MSAD. The crucial outcome of GERD-health-related quality of life (HRQL) score improved from 20 to 3 points in MSAD patients, and from 23 to 3.5 points in LF patients. However, the LF patients were in a more severe stage of the disease. The results yield indefinite conclusions about the use of both MSAD and EST. Clinical effectiveness and safety of both MSAD and EST are not sufficiently proven and are yet to be supported by high quality evidence from randomized controlled trials.

ANALYSIS OF DUPLICATION AND TIMING OF HEALTH TECHNOLOGY ASSESSMENTS ON MEDICAL DEVICES IN EUROPE.

OBJECTIVES: Strengthening efforts toward better collaboration plays a pivotal role in the assessment of medical devices to reduce overlap and save resources. This study explored the level of duplication in health technology assessments (HTA) of medical devices in Europe and their respective timing in order to identify areas for better collaboration. METHODS: An analysis of European HTA reports of medical devices regarding overlaps in topics and timing in relation to market authorization was performed. We conducted a systematic search in the ADVANCE, Centre for Reviews and Dissemination, Syngerus, and POP databases, complemented by hand searching, to identify HTA reports published between 01/2003 and 07/2016 for a preselected cohort group of ten technologies. We analyzed the number of annual assessments per technology and evaluated activity patterns and timing in undertaking the HTA of the different institutes in Europe. RESULTS: The results revealed the amount of duplication in the European HTA production: the number of reports per technology ranged from minimum seven to maximum twenty-two over a time-span of 13.5 years. HTA institutes perform assessments at a similar time range within 5 to 10 years following market authorization. The timing of the initial assessment in relation to the granting of the CE-mark varies according to the particular technology. CONCLUSION: The findings suggest that efficient collaboration may help to save scarce resources and time of HTA institutes in Europe. Efficient collaboration as such needs to shift the focus beyond the time span of 1 year, and build on each's others work from previous assessments.