Additional file 2 of Assessment of learning curves in complex surgical interventions: a consecutive case-series study

Profile likelihood (τ) for surgeon 3. Profile likelihood of τ from the two-phase model fitted on surgeon 3’s series. (PDF 12 kb

Additional file 1 of Assessment of learning curves in complex surgical interventions: a consecutive case-series study

Two-phase model formulation. A detailed description of the formulation and fitting process (via ML estimation) of the two-phase model for both a continuous and a binary outcome. (PDF 174 kb

Multicenter Randomized Trial of Intermittently Scanned Continuous Glucose Monitoring Versus Self-Monitoring of Blood Glucose in Individuals With Type 2 Diabetes and Recent-Onset Acute Myocardial Infarction: Results of the LIBERATES Trial

   Objective Analyse the impact of modern glucose-monitoring strategies on glycemic and patient-related outcomes in individuals with type 2 diabetes (T2D) and recent myocardial infarction (MI), and also assess cost effectiveness.  Research design and methods LIBERATES was a multicentre, two-arm randomised trial comparing self-monitoring of blood glucose (SMBG) with intermittently scanned continuous glucose monitoring (isCGM), also known as flash CGM, in individuals with T2D and recent MI, treated with insulin and/or sulphonylurea prior to hospital admission.  The primary outcome measure was time in range (TIR; glucose 3.9-10 mmol/l)/day on days 76-90 post randomisation. Secondary and exploratory outcomes included time in hypoglycemia, hemoglobin (Hb)A1c, clinical outcome, quality of life (QoL) and cost effectiveness.  Results  Of 141 participants aged [median 63 IQR (53, 70) years, 73% males] randomised, isCGM was associated with increased TIR by 17mins/day (95% credible interval -105, +153mins/day) with 59% probability for a benefit. Users of isCGM showed lower hypoglycemic exposure ( Combined glycemic emergencies/mortality occurred in 4 isCGM and 7 SMBG study participants. QoL measures marginally favoured isCGM and the intervention proved to be cost-effective.  Conclusions Compared with SMBG, isCGM in T2D individuals with MI marginally increases TIR and significantly reduces hypoglycemic exposure while equally improving HbA1c, explaining its cost-effectiveness. Studies are required to understand whether these glycemic differences translate into longer term clinical benefit. </p

Reducing bias in trials due to reactions to measurement: experts produced recommendations informed by evidence

Objective: This study (MEasurement Reactions In Trials) aimed to produce recommendations on how best to minimize bias from measurement reactivity (MR) in randomized controlled trials of interventions to improve health. Study design and setting: The MERIT study consisted of: (1) an updated systematic review that examined whether measuring participants had effects on participants’ health-related behaviors, relative to no-measurement controls, and three rapid reviews to identify: (i) existing guidance on MR; (ii) existing systematic reviews of studies that have quantified the effects of measurement on behavioral or affective outcomes; and (iii) studies that have investigated the effects of objective measurements of behavior on health-related behavior; (2) a Delphi study to identify the scope of the recommendations; and (3) an expert workshop in October 2018 to discuss potential recommendations in groups. Results: Fourteen recommendations were produced by the expert group to: (1) identify whether bias is likely to be a problem for a trial; (2) decide whether to collect data about whether bias is likely to be a problem; (3) design trials to minimize the likelihood of this bias. Conclusion: These recommendations raise awareness of how and where taking measurements can produce bias in trials, and are thus helpful for trial design