AIMS: To compare the efficacy of Gaviscon Advance (Reckitt Benckiser, UK) and a non-alginate antacid in post-supper suppression of the acid pocket and post-prandial reflux among obese participants.
METHODS: Participants underwent 48 h wireless and probe-based pH-metry recording of the acid pocket and lower oesophagus, respectively, and were randomised to single post-supper (10 pm) dose of either Gaviscon Advance or a non-alginate antacid on the second night. Primary outcomes were suppression of median pH of acid pocket and lower oesophagus, measured every 10-minutes post-supper for 1 h. Secondary outcomes were suppression of % time pH
STUDY DESIGN: Prospective observational cohort study.
SETTING & PARTICIPANTS: 552 children and adolescents from 27 countries on maintenance HD followed up prospectively by the International Pediatric HD Network (IPHN) Registry between 2012 and 2017.
PREDICTOR: Type of vascular access: AVF, central venous catheter (CVC), or arteriovenous graft.
OUTCOME: Infectious and noninfectious vascular access complication rates, dialysis performance, biochemical and hematologic parameters, and clinical outcomes.
ANALYTICAL APPROACH: Univariate and multivariable linear mixed models, generalized linear mixed models, and proportional hazards models; cumulative incidence functions.
RESULTS: During 314 cumulative patient-years, 628 CVCs, 225 AVFs, and 17 arteriovenous grafts were placed. One-third of the children with an AVF required a temporary CVC until fistula maturation. Vascular access choice was associated with age and expectations for early transplantation. There was a 3-fold higher living related transplantation rate and lower median time to transplantation of 14 (IQR, 6-23) versus 20 (IQR, 14-36) months with CVCs compared with AVFs. Higher blood flow rates and Kt/Vurea were achieved with AVFs than with CVCs. Infectious complications were reported only with CVCs (1.3/1,000 catheter-days) and required vascular access replacement in 47%. CVC dysfunction rates were 2.5/1,000 catheter-days compared to 1.2/1,000 fistula-days. CVCs required 82% more revisions and almost 3-fold more vascular access replacements to a different site than AVFs (P<0.001).
LIMITATIONS: Clinical rather than population-based data.
CONCLUSIONS: CVCs are the predominant vascular access choice in children receiving HD within the IPHN. Age-related anatomical limitations and expected early living related transplantation were associated with CVC use. CVCs were associated with poorer dialysis efficacy, higher complication rates, and more frequent need for vascular access replacement. Such findings call for a re-evaluation of pediatric CVC use and practices.
METHODS: This prospective clinical study included consecutive Asian patients with dark irides and confirmed for glaucoma. Only one eye of each patient was treated. Diode laser contact transscleral cyclophotocoagulation treatment was performed with the center of the probe placed 1.5 mm behind the limbus. About 30 pulses of 810-mm laser radiation (power, 1.8 to 2.0 W; duration, 0.3 to 0.5 second) were applied around the eye. Patients were examined at fixed postoperative intervals. Intraocular pressure levels and postoperative complications were recorded. The relation between patient and disease characteristics, total laser energy delivered, and intraocular pressure effects were analyzed.
RESULTS: Thirty-three patients were studied, with a mean follow-up period of 9.4 months. An average 56% of patients showed a 30% or greater drop in intraocular pressure. About 38% of patients achieved sustained intraocular pressure lowering to below 22 mm Hg at 18 months. Complications were few and included transient hypotony and iritis.
CONCLUSIONS: In Asian patients with refractory glaucoma or painful glaucomatous eyes with poor visual acuity (defined for this study as worse than 20/200), low-energy-setting diode laser contact transscleral cyclophotocoagulation by means of the glass ball probe is relatively effective and safe.
DESIGN: Retrospective interventional case series.
METHODS: Thirty-nine eyes from 39 patients with a FTMH <600 μm were included from a single institution. All patients underwent vitrectomy using a semicircular single-layered ILM inverted flap assisted by a sub-perfluorocarbon liquid injection of ophthalmic viscoelastic device (OVD) technique. Best-corrected visual acuity (BCVA) and spectral domain optical coherence tomography were used to compare outcomes between nasal (n = 19) and temporal (n = 20) groups.
RESULTS: At 6 months postoperatively, all FTMHs closed and BCVA were significantly improved. Overall, 36 eyes (92%) achieved U-shaped closure, and ellipsoid zone restoration was noted in 24 eyes (62%). An ILM flap was present in 29 eyes (74%) and 86% remained single-layered. There were significantly more deep inner retinal dimples in the temporal group (35%) compared with 5% in the nasal group (P = .04), but these were unrelated to BCVA. Significant retinal thinning in the temporal outer sub-field was noted in the temporal group and was negatively correlated with BCVA (rho [ρ]: - .53; P = .03). No significant postoperative retinal displacement was noted in either group.
CONCLUSIONS: The technique of using sub-perfluorocarbon liquid injection of OVD secured single-layered flaps intraoperatively and postoperatively. Both the nasal and temporal inverted ILM flaps repaired FTMH and improved visual acuity. However, both temporal macular thinning and deep inner retinal dimples were significantly greater in the temporal group.
METHODS: Patients in the permanent dentition requiring maxillary and mandibular fixed orthodontic treatment with a preadjusted edgewise appliance were eligible for inclusion. Patients attending 4 hospital departments (United Kingdom and Italy) were randomly allocated to 1 of 4 treatment interventions: (1) BioCosmetic (Forestadent, Pforzheim, Germany), 0.017 in; (2) Titanol (Forestadent), 0.016 in; (3) TP Aesthetic (TP Orthodontics, La Porte, Ind), 0.014 in; and (4) Tooth Tone (Ortho Organizers, Calsbad, Calif) 0.016 in. Block randomization with block sizes of 4 and 8 was used to ensure an allocation ratio of 1:1:1:1. The primary outcome was alignment efficiency determined by the reduction in Little's irregularity index (mm). Secondary outcomes were color change using the Commission Internationale de L'Eclairage L*a*b* system and percentage of coating loss. Blinding was only applicable to outcome assessment of alignment efficiency. Regression models with Sidak's multiple comparison of means were used to analyze the data.
RESULTS: One hundred fifty patients (300 dental arches) were allocated to the treatment interventions, including 61 male and 89 female subjects with a mean age of 16.60 years. The average duration of follow-up was 63.65 days. Baseline characteristics for the archwire groups were similar. One patient was lost to follow-up. Five percent (n = 15) of the archwires fractured: BioCosmetic, 5.3% (n = 4); Titanol, 6.8% (n = 5); TP Aesthetic, 5.3% (n = 4); and Tooth Tone, 2.7% (n = 2). We analyzed 283 dental arches for alignment efficiency. There was no statistically significant difference for mean reduction in irregularity between the archwire groups (P = 0.627): BioCosmetic (n = 71), 3.86 mm (95% CI, 3.31-4.41); Titanol (n = 69), 4.51 mm (95% CI, 4.00-5.02); TP Aesthetic (n = 71), 4.13 mm (95% CI, 3.49-4.78); and Tooth Tone (n = 72), 4.21 mm (95% CI, 3.89-4.46). There was a statistically significant difference between archwire groups for color change (P = 0.001) and percentage of coating loss (P = 0.001), with BioCosmetic performing best in both parameters.
CONCLUSIONS: There was no difference between the archwires for alignment efficiency. BioCosmetic performed statistically significantly better than did the other groups for both color change and coating loss.
REGISTRATION: This trial was registered with the East Midlands NHS Research Ethics Committee (12/EM/0190).
PROTOCOL: The protocol was not published before trial commencement.
DATA SOURCES: A search of PubMed and other electronic databases comparing LARR and ORR between Jan 2000 and June 2016 was performed. Histopathological variables analyzed included; location of rectal tumors; complete and incomplete TME; positive and negative circumferential resection margins (+/-CRM); positive distal resected margins (+DRM); distance of tumor from DRM; number of lymph nodes harvested; resected specimen length; tumor size and perforated rectum.
RESULTS: Fourteen RCTs totaling 3843 patients (LARR = 2096, ORR = 1747) were analyzed. Comparable effects were noted for all these histopathological variables except for the variable perforated rectum which favored ORR.
CONCLUSIONS: LARR compares favorably to ORR for rectal cancer treatment. However, there is significantly higher risk of rectal perforation during LARR compared to ORR.
STUDY QUESTION: Whether FDA death data in the PLATO trial matched the local site records.
STUDY DESIGN: The NDA spreadsheet contains 938 precisely detailed PLATO deaths. We obtained and validated local evidence for 52 deaths among 861 PLATO patients from 14 enrolling sites in 8 countries and matched those with the official NDA dataset submitted to the FDA.
MEASURES AND OUTCOMES: Existence, precise time, and primary cause of deaths in PLATO.
RESULTS: Discrepant to the NDA document, sites confirmed 2 extra unreported deaths (Poland and Korea) and failed to confirm 4 deaths (Malaysia). Of the remaining 46 deaths, dates were reported correctly for 42 patients, earlier (2 clopidogrel), or later (2 ticagrelor) than the actual occurrence of death. In 12 clopidogrel patients, cause of death was changed to "vascular," whereas 6 NDA ticagrelor "nonvascular" or "unknown" deaths were site-reported as of "vascular" origin. Sudden death was incorrectly reported in 4 clopidogrel patients, but omitted in 4 ticagrelor patients directly affecting the primary efficacy PLATO endpoint.
CONCLUSIONS: Many deaths were inaccurately reported in PLATO favoring ticagrelor. The full extent of mortality misreporting is currently unclear, while especially worrisome is a mismatch in identifying primary death cause. Because all PLATO events are kept in the cloud electronic Medidata Rave capture system, securing the database content, examining the dataset changes or/and repeated entries, identifying potential interference origin, and assessing full magnitude of the problem are warranted.
METHODS: A total of 28 critically ill patients were included in this study. All data were collected from medical, microbiology and pharmacokinetic records. The clinical response was evaluated on the basis of clinical and microbiological parameters. The 24-h area under the curve (AUC0-24) was estimated from a single trough level using established equations.
RESULTS: Out of the 28 patients, 46% were classified as responders to vancomycin treatment. The trough vancomycin concentration did not differ between the responders and non-responders (15.02 ± 6.16 and 14.83 ± 4.80 μg mL-1; P = 0.929). High vancomycin minimum inhibitory concentration (MIC) was observed among the non-responders (P = 0.007). The ratio between vancomycin trough concentration and vancomycin MIC was significantly lower in the non-responder group (8.76 ± 3.43 vs. 12.29 ± 4.85 μg mL-1; P = 0.034). The mean ratio of estimated AUC0-24 and vancomycin MIC was 313.78 ± 117.17 μg h mL-1 in the non-responder group and 464.44 ± 139.06 μg h mL-1 in the responder group (P = 0.004). AUC0-24/MIC of ≥ 400 μg h mL-1 was documented for 77% of the responders and 27% of the non-responders (c2 = 7.03; P = 0.008).
CONCLUSIONS: Ratio of trough concentration/MIC and AUC0-24/MIC of vancomycin are better predictors for MRSA treatment outcomes than trough vancomycin concentration or AUC0-24 alone. The single trough-based estimated AUC may be sufficient for the monitoring of treatment response with vancomycin.
MATERIAL AND METHODS: A total of 58 patients who underwent elective surgery under general anaesthesia were randomised to two ETT groups, the PFT group (n = 29) and the UFR group (n = 29), for OFI in simulated difficult intubation patients using a rigid cervical collar. After successful standardised induction and relaxation, OFI and railroading of selected ETT were subsequently performed by a similarly experienced practitioner. Ease of insertion, degree of manipulation, time to successful intubation, post-intubation complications and haemodynamic changes were recorded for both groups.
RESULTS: he percentage of easy intubation was comparable between both groups with a slightly higher percentage in the UFR group than the PFT group (69.0% vs. 62.0%; P = 0.599). Degree of manipulation was also comparable between the two groups; the percentage of cases in which manipulation was not required was slightly higher in the UFR group than the PFT group (69.0% vs. 62.1%; P = 0.849). Time to successful intubation was also comparable between the groups, although the time was slightly shorter for the UFR group than the PFT group (56.9 s ± 39.7 s vs. 63.9 s ± 36.9 s; P = 0.488). There were also no significant differences in other parameters.
CONCLUSIONS: The Parker flex tip ETT was comparable to the unoflex reinforced ETT for OFI in simulated difficult airway patients.
OBJECTIVE: To determine the effect of a physiologically compatible pH moisturizer in atopic dermatitis.
METHODS: A randomized half body, double blind, controlled trial involving patients with stable atopic dermatitis was performed. pH-modified moisturizer and standard moisturizer were applied to half body for 6 weeks.
RESULTS: A total of 6 (16.7%) males and 30 (83.3%) females participated. Skin pH reductions from week 0, week 2 and 6 were significant at the forearms (5.315 [0.98] to 4.85 [0.54] to 5.04 [0.78], p=0.02) and abdomen (5.25 [1.01], 4.82 [0.64], 5.01 [0.59], p=0.00) but not at the shins (5.01 [0.80], 4.76 [0.49], 4.85 [0.79], p=0.09) with pH-modified moisturizer. Transepidermal water loss (TEWL) at the forearms decreased (4.60 [2.55] to 3.70 [3.10] to 3.00 [3.55], p=0.00), abdomen (3.90 [2.90] to 2.40 [3.45] to 2.70 [2.25], p=0.046). SCORAD improved from 14.1±12.75 to 10.5±13.25 to 7±12.25, p=0.00. In standard moisturizer group, pH reductions were significant at the forearms (5.29 [0.94] to 4.84 [0.55] to 5.02 [0.70], p=0.00) and abdomen (5.25 [1.09], 4.91 [0.63], 5.12 [0.66], p=0.00). TEWL at the forearm were (4.80 [2.95], 4.10 [2.15], 4.60 [3.40], p=0.67), shins (3.80 [1.40], 3.50 [2.35], 4.00 [2.50], p=0.91) and abdomen (3.70 [2.45], 4.10 [3.60], 3.40 [2.95], p=0.80). SCORAD improved from 14.2±9.1 to 10.9±10.65 to 10.5±11, p=0.00. Reduction in pH was observed with both moisturizers while TEWL significantly improved with pH-modified moisturizer. pH-modified moisturizer resulted in greater pH, TEWL and SCORAD improvements however the differences were not significant from standard moisturizer.
STUDY LIMITATION: Skin hydration was not evaluated.
CONCLUSION: Moisturization is beneficial for atopic dermatitis; use of physiologically compatible pH moisturizer is promising.