Materials and Methods: The research question was developed by using Population, Intervention, Comparison, Outcome and Study design framework. Literature search was performed using 3 electronic databases PubMed, Scopus, and EBSCOhost until October 2019. Two reviewers were independently involved in the selection of the articles and data extraction process. Risk of bias of the studies was independently appraised using revised Cochrane Risk of Bias tool (RoB 2.0) based on 5 domains.
Results: Thirteen studies fulfilled the selection criteria. The overall risk of bias was moderate. QMix was found to have better smear layer removal ability than mixture of tetracycline isonomer, an acid and a detergent (MTAD), sodium hypochlorite (NaOCl), and phytic acid. The efficacy was less effective than 7% maleic acid and 10% citric acid. No conclusive results could be drawn between QMix and 17% ethylenediaminetetraacetic acid due to conflicting results. QMix was more effective when used for 3 minutes than 1 minute.
Conclusions: QMix has better smear layer removal ability compared to MTAD, NaOCl, Tubulicid Plus, and Phytic acid. In order to remove the smear layer more effectively with QMix, it is recommended to use it for a longer duration.
METHODS: A prospective 7-country clinical trial of 302 OSA patients, who met the selection criteria, and underwent nose, palate and/or tongue surgery. Pre- and post-operative data were recorded and analysed based on both the Sher criteria (apnoea hypopnea index, AHI reduction 50% and <20) and the SLEEP-GOAL.
RESULTS: There were 229 males and 73 females, mean age of 42.4±17.3 years, mean BMI 27.9±4.2. The mean VAS score improved from 7.7±1.4 to 2.5±1.7 (p<0.05), mean Epworth score (ESS) improved from 12.2±4.6 to 4.9±2.8 (p<0.05), mean body mass index (BMI) decreased from 27.9±4.2 to 26.1±3.7 (p>0.05), gross weight decreased from 81.9±14.3kg to 76.6±13.3kg. The mean AHI decreased 33.4±18.9 to 14.6±11.0 (p<0.05), mean lowest oxygen saturation (LSAT) improved 79.4±9.2% to 86.9±5.9% (p<0.05), and mean duration of oxygen <90% decreased from 32.6±8.9 minutes to 7.3±2.1 minutes (p<0.05). The overall success rate (302 patients) based on the Sher criteria was 66.2%. Crosstabulation of respective major/minor criteria fulfilment, based on fulfilment of two major and two minor or better, the success rate (based on SLEEP-GOAL) was 69.8%. Based solely on the Sher criteria, 63 patients who had significant blood pressure reduction, 29 patients who had BMI reduction and 66 patients who had clinically significant decrease in duration of oxygen <90% would have been misclassified as "failures".
CONCLUSION: AHI as a single parameter is unreliable. Assessing true success outcomes of OSA treatment, requires comprehensive and holistic parameters, reflecting true end-organ injury/function; the SLEEP-GOAL meets these requirements.
MATERIALS AND METHOD: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197).
RESULTS: Multiple barriers were identified, and were regrouped as patient- related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.
DESIGN: AVERT is a prospective, parallel group, assessor-blinded randomised clinical trial. This paper presents data assessing the generalisability of AVERT.
SETTING: Acute stroke units at 44 hospitals in 8 countries.
PARTICIPANTS: The first 20,000 patients screened for AVERT, of whom 1158 were recruited and randomised.
MODEL: We use the Proximal Similarity Model, which considers the person, place, and setting and practice, as a framework for considering generalisability. As well as comparing the recruited patients with the target population, we also performed an exploratory analysis of the demographic, clinical, site and process factors associated with recruitment.
RESULTS: The demographics and stroke characteristics of the included patients in the trial were broadly similar to population-based norms, with the exception that AVERT had a greater proportion of men. The most common reason for non-recruitment was late arrival to hospital (ie, >24 h). Overall, being older and female reduced the odds of recruitment to the trial. More women than men were excluded for most of the reasons, including refusal. The odds of exclusion due to early deterioration were particularly high for those with severe stroke (OR=10.4, p<0.001, 95% CI 9.27 to 11.65).
CONCLUSIONS: A model which explores person, place, and setting and practice factors can provide important information about the external validity of a trial, and could be applied to other clinical trials.
TRIAL REGISTRATION NUMBER: Australian New Zealand Clinical Trials Registry (ACTRN12606000185561) and Clinicaltrials.gov (NCT01846247).
METHODS AND RESULTS: The primary outcome (risk of cardiac failure, pacemaker syndrome, or syncope related to the Micra system or procedure) was compared between successfully implanted patients from the Micra IDE trial with a primary pacing indication associated with AF or history of AF (AF group) and those without (non-AF group). Among 720 patients successfully implanted with Micra, 228 (31.7%) were in the non-AF group. Reasons for selecting VVI pacing in non-AF patients included an expectation for infrequent pacing (66.2%) and advanced age (27.2%). More patients in the non-AF group had a condition that precluded the use of a transvenous pacemaker (9.6% vs. 4.7%, P = 0.013). Atrial fibrillation patients programmed to VVI received significantly more ventricular pacing compared to non-AF patients (median 67.8% vs. 12.6%; P patients selected to receive Micra VVI therapy were for indications not associated with AF. Non-AF VVI patients required less frequent pacing compared to patients with AF. Risks associated with VVI therapy were low and did not differ in those with and without AF.
SETTING: The analysis was from the perspective of the National Health Service in England and Wales.
PARTICIPANTS: 6221 patients from four of the Hyperglycaemia and Adverse Pregnancy Outcomes (HAPO) study centres (two UK, two Australian), 6308 patients from the Atlantic Diabetes in Pregnancy study and 12 755 patients from UK clinical practice.
PRIMARY AND SECONDARY OUTCOME MEASURES PLANNED: The incremental cost per quality-adjusted life year (QALY), net monetary benefit (NMB) and the probability of being cost-effective at CE thresholds of £20 000 and £30 000 per QALY.
RESULTS: In a population of pregnant women from the four HAPO study centres and using NICE-defined risk factors for GDM, diagnosing GDM using NICE 2015 criteria had an NMB of £239 902 (relative to no treatment) at a CE threshold of £30 000 per QALY compared with WHO 2013 criteria, which had an NMB of £186 675. NICE 2015 criteria had a 51.5% probability of being cost-effective compared with the WHO 2013 diagnostic criteria, which had a 27.6% probability of being cost-effective (no treatment had a 21.0% probability of being cost-effective). For women without NICE risk factors in this population, the NMBs for NICE 2015 and WHO 2013 criteria were both negative relative to no treatment and no treatment had a 78.1% probability of being cost-effective.
CONCLUSION: The NICE 2015 diagnostic criteria for GDM can be considered cost-effective relative to the WHO 2013 alternative at a CE threshold of £30 000 per QALY. Universal screening for GDM was not found to be cost-effective relative to screening based on NICE risk factors.
METHODS: This was a descriptive, retrospective analysis, conducted at the Department of Paediatrics, University Malaya Medical Centre, Malaysia. All children who had esophagogastroduodenoscopy (EGD) and colonoscopy from January 2008 to June 2011 were included. An endoscopy was considered appropriate when its indication complied with the NASPGHAN and ASGE guideline. All endoscopic findings were classified as either positive (presence of any endoscopic or histologic abnormality) or negative (no or minor abnormality, normal histology); effecting a positive contributive (a change in therapeutic decisions or prognostic consequences) or non-contributive yield (no therapeutic or prognostic consequences).
RESULTS: Overall, 76% of the 345 procedures (231 EGD alone, 26 colonoscopy alone, 44 combined EGD and colonoscopy) performed in 301 children (median age 7.0 years, range 3 months to 18 years) had a positive endoscopic finding. Based on the NASPGHAN and ASGE guideline, 99.7% of the procedures performed were considered as appropriate. The only inappropriate procedure (0.3%) was in a child who had EGD for assessment of the healing of gastric ulcer following therapy in the absence of any symptoms. The overall positive contributive yield for a change in diagnosis and/or management was 44%. The presence of a positive endoscopic finding was more likely to effect a change in the therapeutic plan than an alteration of the initial diagnosis. A total of 20 (5.8%) adverse events were noted, most were minor and none was fatal.
CONCLUSION: The NASPGHAN and ASGE guideline is more likely to predict a positive endoscopic finding but is less sensitive to effect a change in the initial clinical diagnosis or the subsequent therapeutic plan.