Embryo incubation by time-lapse systems versus conventional incubators in Chinese women with diminished ovarian reserve undergoing IVF/ICSI: a study protocol for a randomised controlled trial

Alexandros G.Sfakianakis shared this article with you from Inoreader Embryo incubation by time-lapse systems versus conventional incubators in Chinese women with diminished ovarian reserve undergoing IVF/ICSI: a study protocol for a randomised controlled trial Μέσω BMJ Open Current Issue Introduction The time-lapse imaging system (TLS) is a newly developed non-invasive embryo assessment system. Compared with conventional incubators, a TLS provides stable culture conditions and consistent observations of embryo development, thereby potentially improving embryo quality and selection of the best quality embryo. Although TLSs have been routinely used in many in vitro fertilisation (IVF) centres globally, there is insufficient evidence to indicate that TLSs result in higher cumulative live birth rates over conventional incubators. The purpose of this study is to compare the cumulative live birth rates and safety including miscarriage in infertile patients with diminished ovarian reserve (DOR) from both TLSs and conventional incubators. Methods and analysis This study is a double-blind randomised controlled clinical trial (1:1 treatment ratio of TLSs vs conventional incubator). A total of 730 patients with DOR undergoing the first or second cycle of IVF or intracytoplasmic sperm injection (ICSI) will be enrolled and randomised into two parallel groups. Participants will undergo embryo culture in the TLSs (group A) or the conventional incubators (group B), respectively. Embryos are selected for transfer in both groups by the morphological characteristics. The embryo selection algorithm software is not used in the TLSs. The primary outcome is the cumulative live birth rate of the trial IVF/ICSI cycle within 12 months after randomisation. This study is powered to detect an absolute difference of 10% (35% vs 25%) at the significance level of 0.05% and 80% statistical power based on a two-sided test. Ethics and dissemination This trial has been approved by the Institutional Ethical Committee of Shanghai First Maternity and Infant Hospital (KS1958). All participants in the trial will provide written informed consent. The study will be conducted according to the principles outlined in the Declaration of Helsinki and its amendments. Results of this study will be disseminated in peer-reviewed scientific journals. Trial registration number Chinese Clinical Trial Registry (ChiCTR1900027746). View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial

Alexandros G.Sfakianakis shared this article with you from Inoreader Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65): protocol and statistical analysis plan for a randomised clinical trial Μέσω BMJ Open Current Issue Introduction Vasodilatory hypotension is common among intensive care unit (ICU) patients; vasopressors are considered standard of care. However, optimal mean arterial pressure (MAP) targets for vasopressor titration are unknown. The objective of the Optimal VAsopressor TitraTION in patients 65 years and older (OVATION-65) trial is to ascertain the effect of permissive hypotension (vasopressor titration to achieve MAP 60–65 mm Hg) versus usual care on biomarkers of organ injury in hypotensive patients aged ≥65 years. Methods and analysis OVATION-65 is an allocation-concealed randomised trial in 7 Canadian hospitals. Eligible patients are ≥65 years of age, in an ICU with vasodilatory hypotension, receiving vasopressors for ≤12 hours to maintain MAP ≥65 mm Hg during or after adequate fluid resuscitation, and expected to receive vasopressors for ≥6 additional hours. Patients are excluded for any of the following: active treatment for spinal cord or acute brain injury; vasopressors given solely for bleeding, ventricular failure or postcardiopulmonary bypass vasoplegia; withdrawal of life-sustaining treatments expected within 48 hours; death perceived as imminent; previous enrolment in OVATION-65; organ transplant within the last year; receiving extracorporeal life support or lack of physician equipoise. Patients are randomised to permissive hypotension versus usual care for up to 28 days. The primary outcome is high-sensitivity troponin T, a biomarker of cardiac injury, on day 3. Secondary outcomes include bio markers of injury to other organs (brain, liver, intestine, skeletal muscle); lactate (a biomarker of global tissue dysoxia); resource utilisation; adverse events; mortality (90 days and 6 months) and cognitive function (6 months). Assessors of biomarkers, mortality and cognitive function are blinded to allocation. Ethics and dissemination This protocol has been approved at all sites. Consent is obtained from the eligible patient, the substitute decision-maker if the patient is incapable, or in a deferred fashion where permitted. End-of-grant dissemination plans include presentations, publications and social media platforms and discussion forums. Trial registration number NCT03431181. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Relationships among shift work, hair cortisol concentration and sleep disorders: a cross-sectional study in China

Alexandros G.Sfakianakis shared this article with you from Inoreader Relationships among shift work, hair cortisol concentration and sleep disorders: a cross-sectional study in China Μέσω BMJ Open Current Issue Objective The present study was designed to demonstrate the relationships among shift work, hair cortisol concentration (HCC) and sleep disorders. Design A cross-sectional study. Setting Three petroleum administrations in Karamay city of Xinjiang, China. Participants 435 individuals including 164 males and 271 females participated in the research. Outcome measures Information on shift work was collected by a self-administered questionnaire. HCC was determined using an automatic radioimmunoassay instrument. Sleep quality was measured on the Pittsburgh Sleep Quality Index scale. Results Shiftwork was associated with an increased prevalence of sleep disorders compared with the fixed day shift (two shifts: OR 3.11, 95% CI 1.57 to 6.19; three shifts: OR 2.87, 95% CI 1.38 to 5.98; four shifts: OR 2.22, 95% CI 1.17 to 4.18; others: OR 3.88, 95% CI= 1.36 to 11.08). Workers with different shift patterns had higher HCC levels than day workers ((fixed day shift: geometric mean±geometric SD=2.33±1.65; two shifts: 3.76±1.47; three shifts: 3.15±1.64; four shifts: 3.81±1.55; others: 3.60±1.33) ng/g hair, 2=0.174) and high HCC was associated with the higher prevalence of sleep disorders (OR 4.46, 95% CI 2.70 to 7.35). The mediating effect of HCC on the relationship between shift work and sleep disorders was 0.25 (95% CI 0.09 to 0.41). Conclusion We found that, when compared with the fixed day shift, shiftwork was associated with both the higher HCC, and also with an increased risk of sleep disorders. High HCC was associated with the occurrence of sleep disorders. In addition, HCC had mediating effect in shift work and sleep disorders. Thus, HCC can be considered as an early marker of shiftwork circadian disruption to early detection and management of sleep disorders. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Assessment of a patient-reported outcome measure in men with prostate cancer who had radical surgery: a Rasch analysis

Alexandros G.Sfakianakis shared this article with you from Inoreader Assessment of a patient-reported outcome measure in men with prostate cancer who had radical surgery: a Rasch analysis Μέσω BMJ Open Current Issue Objectives To evaluate the psychometric properties (and identify specific anomalies to be resolved) of urinary and sexual function scales of the Symptom Tracking and Reporting (STAR) instrument for use in clinical practice with individual men using Rasch analysis. Design Prospective cohort study. Setting 9 UK surgery centres in secondary care. Participants 403 men diagnosed with prostate cancer and completed at least one questionnaire immediately before and at 1 or 3 months after radical prostatectomy. Primary and secondary outcomes STAR instrument before surgery and 1 and 3 months afterwards. Results Neither scale fitted the Rasch model (both scales p<0.001). Both urinary (seven items) and sexual function (six items) had disordered thresholds, suggesting response categories are not working as intended. Both scales (three urinary items; five sexual function items) showed problems with item fit (large fit residuals, significant 2, an inspection of item characteristic curves). Both scales showed items that were unstable over time (differential item functioning (DIF) by time). Both scales (four pairs of items in each scale) showed local response dependency (residual correlations >0.2 above the average). Internal consistency was acceptable at the group level for both scales. Targeting was poor for both scales, indicating an inadequate match between the location of items and the distribution of the patients, suggesting that the underlying constructs that the scales purport to measure are not clear. Conclusion Using Rasch analysis as a diagnostic tool, we identified that both the urinary and the sexual function scales have issues that need to be resolved before STAR can be used with confidence in clinical practice. The sexual function scale, in particular, is unlikely to provide precise estimates for the outcomes experienced by men after radical prostatectomy. These results demonstrate the need to evaluate the suitability of any patient-reported outcome measure before implementation in routine clinical practice, preferably using modern psychometric methods. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Vascular and metabolic risk factor differences prior to dementia diagnosis: a multidatabase case-control study using European electronic health records

Alexandros G.Sfakianakis shared this article with you from Inoreader Vascular and metabolic risk factor differences prior to dementia diagnosis: a multidatabase case-control study using European electronic health records Μέσω BMJ Open Current Issue Objective The objective of the study is to compare body mass index (BMI), systolic/diastolic blood pressure (SBP/DBP) and serum total cholesterol levels between dementia cases and controls at multiple time intervals prior to dementia onset, and to test time interval as a modifying factor for these associations. Design Case–control study. Setting Six European electronic health records databases. Participants 291 780 cases at the date of first-recorded dementia diagnosis, compared with 29 170 549 controls randomly selected from the same databases, age matched and sex matched at this index date. Exposure The following measures were extracted whenever recorded within each dataset: BMI (kg/m2), SBP and DBP (mm Hg) and serum total cholesterol (mmol/L). Levels for each of these variables were defined within six 2-year time intervals over the 12 years prior to the index date. Main outcomes Case–control differences in exposures of interest were modelled for each time period and adjusted for demographic and clinical factors (ischaemic/unspecified stroke, type 2 diabetes mellitus, acute myocardial infarction, hypertension diagnosis, antihypertensive medication, cholesterol-lowering medication). Coefficients and interactions with time period were meta-analysed across the six databases. Results Mean BMI (coefficient –1.16 kg/m2; 95% CI –1.38 to 0.93) and SBP (–2.83 mm Hg; 95% CI –4.49 to –1.16) were lower in cases at diagnosis, and case–control differences were greater in more recent time periods, as indicated by significant case-x-time interaction and case-x-time-squared interaction terms. Time variations in coefficients for cholesterol levels were less consistent between databases and those for DBP were largely not significant. Conclusion Routine clinical data show emerging divergence in levels of BMI and SBP prior to the diagnosis of dementia but less evidence for DBP or total cholesterol levels. These divergences should receive at least some consideration in routine dementia risk screening, although underlying mechanisms still require further investigation. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial

Alexandros G.Sfakianakis shared this article with you from Inoreader Efficacy and safety of early treatment with sarilumab in hospitalised adults with COVID-19 presenting cytokine release syndrome (SARICOR STUDY): protocol of a phase II, open-label, randomised, multicentre, controlled clinical trial Μέσω BMJ Open Current Issue Introduction About 25% of patients with COVID-19 develop acute respiratory distress syndrome (ARDS) associated with a high release of pro-inflammatory cytokines such as interleukin-6 (IL-6). The aim of the SARICOR study is to demonstrate that early administration of sarilumab (an IL-6 receptor inhibitor) in hospitalised patients with COVID-19, pulmonary infiltrates and a high IL-6 or D-dimer serum level could reduce the progression of ARDS requiring high-flow nasal oxygen or mechanical ventilation (non-invasive or invasive). Methods and analysis Phase II, open-label, randomised, multicentre, controlled clinical trial to study the efficacy and safety of the administration of two doses of sarilumab (200 and 400 mg) plus best available therapy (BAT) in hospitalised adults with COVID-19 presenting cytokine release syndrome. This strategy will be compared with a BAT control group. The efficacy and safety will be monitored up to 28 days postadministration. A total of 120 patients will be recruited (40 patients in each arm). Ethics and dissemination The clinical trial has been approved by the Research Ethics Committee of the coordinating centre and authorised by the Spanish Agency of Medicines and Medical Products. If the hypothesis is verified, the dissemination of the results could change clinical practice by increasing early administration of sarilumab in adult patients with COVID-19 presenting cytokine release syndrome, thus reducing intensive care unit admissions. Trial registration number NCT04357860. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.

Association of nephrolithiasis with the risk of cardiovascular diseases: a longitudinal follow-up study using a national health screening cohort

Alexandros G.Sfakianakis shared this article with you from Inoreader Association of nephrolithiasis with the risk of cardiovascular diseases: a longitudinal follow-up study using a national health screening cohort Μέσω BMJ Open Current Issue Objectives The aim of this study was to explore the associations of stroke and ischaemic heart disease in patients with nephrolithiasis. Design A longitudinal follow-up study. Setting Data from the Korean National Health Insurance Service–Health Screening Cohort (2002–2013) were retrieved to identify the occurrence of nephrolithiasis. Participants and interventions In total, 19 103 patients with nephrolithiasis were matched at a 1:4 ratio with control participants for age, sex, income and region of residence. Primary and secondary outcome measures The occurrence of stroke and ischaemic heart disease was analysed in both patients with nephrolithiasis and control participants. The primary outcome was HRs of stroke and ischaemic heart disease in a stratified Cox proportional hazards model. Smoking, alcohol consumption, obesity and Charlson Comorbidity Index were adjusted for as covariates. Subgroup analyses according to age and sex were also performed. Results Eight per cent (1615/19 103) of patients with nephrolithiasis and 7.2% (5476/76 412) of control participants had stroke. Nine per cent (1879/19 103) of patients with nephrolithiasis and 7.7% (5895/76 412) of control participants had ischaemic heart disease. Patients with nephrolithiasis had risks of stroke and ischaemic heart disease that were 1.18 times (95% CI=1.11 to 1.24) and 1.24 times (95% CI=1.18 to 1.31) those of the control participants, respectively. The age and sex subgroups showed consistent results. Conclusions Nephrolithiasis was associated with increased risks of stroke and ischaemic heart disease. View on the web Inoreader. Take back control of your news feed. Follow us on Twitter and Facebook.