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Objective: To evaluate the effectiveness of viscosupplementation with single-injection hylan G-F20 (Synvisc-One) in knee osteoarthritis (OA), during routine clinical care, in a 52 week observational study.Research Design and Methods: The LOBRAS study involved a 1 year long, multi-center, quasi-experimental, repeated measures, observational study. Consenting patients in Australia fulfilling inclusion/exclusion criteria under the care of a medical specialist in routine clinical practice were enrolled. Prior to, and for 52 weeks following, intra-articular single-injection hylan G-F20, patients were repeatedly evaluated using the WOMAC NRS4.1 Index and the SF-36 questionnaire. The WOMAC NRS4.1 was administered by mobile phone (with paper back-up), and the SF-36 was administered on paper. Patients were monitored for adverse events.Main Outcome Measures: Western Ontario and McMaster (WOMAC) OA Index, and the Short Form 36 questionnaire (SF-36 v2).Results: A total of 131 patients with knee OA were enrolled, of whom 119 provided both pre- and post-intervention WOMAC data. Statistically significant improvements (with a maximum of p ≤ .025) from baseline to Week 12, Month 6 and Week 52 were detected, by intention-to-treat (ITT) and per-protocol (PP) analyses, in WOMAC Pain, Stiffness, Function, PGA, and Total Score, SF-36 PCS, and WOMAC-derived HUI3. Adverse event (AE) monitoring detected treatment-related AEs in 5.3% of patients.Conclusions: The effectiveness of single-injection hylan G-F20 in routine clinical care is supported by the detection of statistically significant, clinically important improvements in WOMAC Pain, Stiffness, Function, Total, and PGA outcomes, and statistically significant improvements in SF-36 PCS and WOMAC-derived HUI3 outcomes at multiple time points. Limitations of this study include lack of a control group or blinding. No predictive indicators of the response to treatment were identified. In general single-injection hylan G-F20 was well tolerated with very few patients experiencing any treatment-related adverse events. Collectively, these observations attest to the effectiveness of single-injection hylan G-F20 and complement previous observations in routine clinical care. [ABSTRACT FROM AUTHOR]

Objective: To determine the impact of endobronchial coils on health-related quality-of-life (HRQoL). This paper utilizes trial data to identify the predictors of HRQoL in patients with severe emphysema, and subsequently estimates the impact of a new treatment on HRQoL (measured by utilities). These utility estimates are used to generate indicative long-term QALY estimates for a range of clinically plausible scenarios as a precursor to cost-effectiveness analyses.Methods: Patient level HRQoL data from RENEW and the National Emphysema Treatment Trial (NETT) were combined and mapped to generic EuroQol 5-dimension health utility questionnaire (EQ-5D) values using a published algorithm. Multilevel statistical models were developed using treatment, time, response, and baseline characteristics (EQ-5D, age, gender, FEV1, lung RV) to predict EQ-5D over time. Lifetime QALY estimates were generated using published survival data from NETT (assuming no impact of treatment on mortality) and four clinically plausible response profiles. Each response profile was combined with assumptions around treatment impact (constant or time varying).Results: After controlling for baseline characteristics, both treatment and response had a statistically significant impact (p < .001) on utility (+0.101 and +0.061, respectively). When combined with selected baseline characteristics and time, Coils and Standard of Care (SoC) generated more QALYs than SoC alone in all scenarios, with incremental lifetime benefit ranging from 0.29-0.55 QALYs.Conclusions: Coils and SoC resulted in statistically significant improvements in HRQoL compared to SoC alone in patients with severe emphysema. [ABSTRACT FROM AUTHOR]

Objective:Standardized strategy of bowel preparation before video capsule endoscopy (VCE) remains controversial. This study aimed to assess the ideal dose of PEG, based on small bowel visualization quality (SBVQ), diagnostic yield (DY), and complete rate (CR) of VCE using a network meta-analysis (NMA) of randomized controlled trials (RCTs). Methods:This NMA included RCTs comparing any of the following bowel preparation interventions for VCE: fasting overnight (“Fast”), 1 liter PEG (“PEG 1L”), 2-liter PEG (“PEG 2L”), or 4-liter PEG (“PEG 4L”). The authors searched papers in PubMed, Cochrane Library, and Embase as of June 2016. The cumulative ranking (SUCRA) probabilities to rank different doses of PEG and Fast were used. Results:The search engine provided 102 studies. Nine RCTs including 982 patients were incorporated into this analysis. All studies showed low risk of bias of blinding. SUCRA provided an initial ranking among these strategies, in which PEG 2 L showed the best score in SBVQ (PEG 2 L, 89.4%; PEG 1 L, 62.5%; PEG 4 L, 44.0%; Fast, 4.1%) and DY (PEG 2 L, 74.6%; PEG 1 L 28.1%; PEG 4 L 65.9%; Fast 31.4%) of VCE. No significant difference was shown in the analysis of CR. Conclusions:This study recommends PEG 2 L as the ideal dose, which may improve the SBVQ of VCE and, therefore, diagnostic accuracy. Multi-center randomized controlled trials are required to verify these findings. [ABSTRACT FROM PUBLISHER]