Obesity during pregnancy is associated with a number of adverse obstetric outcomes that include gestational diabetes mellitus, macrosomia, and preeclampsia. Increasing evidence shows that bariatric ...surgery may decrease the risk of these outcomes. Our aim was to evaluate the benefits and risks of bariatric surgery in obese women according to obstetric outcomes.
We performed a systematic literature search using MEDLINE, Embase, Cochrane, Web of Science, and PubMed from inception up to December 12, 2016. Studies were included if they evaluated patients who underwent bariatric surgery, reported subsequent pregnancy outcomes, and compared these outcomes with a control group.
Two reviewers extracted study outcomes independently, and risk of bias was assessed with the use of the Newcastle-Ottawa Quality Assessment Scale. Pooled odds ratios for each outcome were estimated with the Dersimonian and Laird random effects model.
After a review of 2616 abstracts, 20 cohort studies and approximately 2.8 million subjects (8364 of whom had bariatric surgery) were included in the metaanalysis. In our primary analysis, patients who underwent bariatric surgery showed reduced rates of gestational diabetes mellitus (odds ratio, 0.20; 95% confidence interval, 0.11–0.37, number needed to benefit, 5), large-for-gestational-age infants (odds ratio, 0.31; 95% confidence interval, 0.17–0.59; number needed to benefit, 6), gestational hypertension (odds ratio, 0.38; 95% confidence interval, 0.19–0.76; number needed to benefit, 11), all hypertensive disorders (odds ratio, 0.38; 95% confidence interval, 0.27–0.53; number needed to benefit, 8), postpartum hemorrhage (odds ratio, 0.32; 95% confidence interval, 0.08–1.37; number needed to benefit, 21), and caesarean delivery rates (odds ratio, 0.50; 95% confidence interval, 0.38–0.67; number needed to benefit, 9); however, group of patients showed an increase in small-for-gestational-age infants (odds ratio, 2.16; 95% confidence interval, 1.34–3.48; number needed to harm, 21), intrauterine growth restriction (odds ratio, 2.16; 95% confidence interval, 1.34–3.48; number needed to harm, 66), and preterm deliveries (odds ratio, 1.35; 95% confidence interval, 1.02–1.79; number needed to harm, 35) when compared with control subjects who were matched for presurgery body mass index. There were no differences in rates of preeclampsia, neonatal intensive care unit admissions, stillbirths, malformations, and neonatal death. Malabsorptive surgeries resulted in a greater increase in small-for-gestational-age infants (P=.0466) and a greater decrease in large-for-gestational-age infants (P=<.0001) compared with restrictive surgeries. There were no differences in outcomes when we used administrative databases vs clinical charts.
Although bariatric surgery is associated with a reduction in the risk of several adverse obstetric outcomes, there is a potential for an increased risk of other important outcomes that should be considered when bariatric surgery is discussed with reproductive-age women.
It is known that people receiving immune suppressive therapy, such as recipients of solid-organ transplants, have a suboptimal response to SARS-CoV-2 vaccination. In a randomized, double-blind trial, ...a third dose of the mRNA-1273 vaccine was compared with placebo. The third dose of vaccine produced a significant boost in neutralizing antibodies.
Abstract
BACKGROUND
Although surgery for endometriosis can improve pain and fertility, the risk of disease recurrence is high. There is little consensus regarding the benefit of medical therapy in ...preventing recurrence of endometriosis following surgery.
OBJECTIVE AND RATIONALE
We performed a review of prospective observational studies and randomised controlled trials (RCTs) to evaluate the risk of endometriosis recurrence in patients undergoing post-operative hormonal suppression, compared to placebo/expectant management.
SEARCH METHODS
The following databases were searched from inception to March 2020 for RCTs and prospective observational cohort studies: MEDLINE, Embase, Cochrane CENTRAL and Web of Science. We included English language full-text articles of pre-menopausal women undergoing conservative surgery (conserving at least one ovary) and initiating hormonal suppression within 6 weeks post-operatively with either combined hormonal contraceptives (CHC), progestins, androgens, levonorgesterel-releasing intra-uterine system (LNG-IUS) or GnRH agonist or antagonist. We excluded from the final analysis studies with <12 months of follow-up, interventions of diagnostic laparoscopy, experimental/non-hormonal treatments or combined hormonal therapy. Risk of bias was assessed using the Cochrane Risk of Bias Tool for RCTs and the Newcastle-Ottawa Scale (NOS) for observational studies.
OUTCOMES
We included 17 studies (13 RCTs and 4 cohort studies), with 2137 patients (1189 receiving post-operative suppression and 948 controls), which evaluated various agents: CHC (6 studies, n = 869), progestin (3 studies, n = 183), LNG-IUS (2 studies, n = 94) and GnRH agonist (9 studies, n = 1237). The primary outcome was post-operative endometriosis recurrence, determined by imaging or recurrence of symptoms, at least 12 months post-operatively. The secondary outcome was change in endometriosis-related pain. Mean follow up of included studies ranged from 12 to 36 months, and outcomes were assessed at a median of 18 months. There was a significantly decreased risk of endometriosis recurrence in patients receiving post-operative hormonal suppression compared to expectant management/placebo (relative risk (RR) 0.41, 95% CI: 0.26 to 0.65), 14 studies, 1766 patients, I2 = 68%, random effects model). Subgroup analysis on patients treated with CHC and LNG-IUS as well as sensitivity analyses limited to RCTs and high-quality studies showed a consistent decreased risk of endometriosis recurrence. Additionally, the patients receiving post-operative hormonal suppression had significantly lower pain scores compared to controls (SMD −0.49, 95% CI: −0.91 to −0.07, 7 studies, 652 patients, I2 = 68%).
WIDER IMPLICATIONS
Hormonal suppression should be considered for patients not seeking pregnancy immediately after endometriosis surgery in order to reduce disease recurrence and pain. Various hormonal agents have been shown to be effective, and the exact treatment choice should be individualised according to each woman’s needs.
IMPORTANCE: Bayesian analysis of clinical trial data may provide useful information to aid in study interpretation, especially when trial evidence suggests that the benefits of an intervention are ...uncertain, such as in a trial that evaluated early extracorporeal membrane oxygenation (ECMO) for severe acute respiratory distress syndrome (ARDS). OBJECTIVE: To demonstrate the potential utility of Bayesian analyses by estimating the posterior probability, under various assumptions, that early ECMO was associated with reduced mortality in patients with very severe ARDS in a randomized clinical trial (RCT). DESIGN AND EVIDENCE: A post hoc Bayesian analysis of data from an RCT (ECMO to Rescue Lung Injury in Severe ARDS EOLIA) that included 249 patients with very severe ARDS who had been randomized to receive early ECMO (n = 124; mortality at 60 days, 35%) vs initial conventional lung-protective ventilation with the option for rescue ECMO (n = 125, mortality at 60 days, 46%). The trial was designed to detect an absolute risk reduction (ARR) of 20%, relative risk (RR) of 0.67. Statistical prior distributions were specified to represent varying levels of preexisting enthusiasm or skepticism for ECMO and by Bayesian meta-analysis of previously published studies (with downweighting to account for differences and quality between studies). The RR, credible interval (CrI), ARR, and probability of clinically important mortality benefit (varying from RR less than 1 to RR less than 0.67 and ARR from 2% or more to 20% or more) were estimated with Bayesian modeling. FINDINGS: Combining a minimally informative prior distribution with the findings of the EOLIA trial, the posterior probability of RR less than 1 for mortality at 60 days after randomization was 96% (RR, 0.78 95% CrI, 0.56-1.04); the posterior probability of RR less than 0.67 was 18%, the probability of ARR of 2% or more was 92%, and the probability of ARR of 20% or more was 2%. With a moderately enthusiastic prior, equivalent to information from a trial of 264 patients with an RR of 0.78, the estimated RR was 0.78 (95% CrI, 0.63-0.96), the probability of RR less than 1 was 99%, the probability of RR less than 0.67 was 8%, the probability of ARR of 2% or more was 97%, and the probability of ARR of 20% or more was 0%. With a strongly skeptical prior, equivalent to information from a trial of 264 patients with an RR of 1.0, the estimated RR was 0.88 (95% CrI, 0.71-1.09), the probability of RR less than 1 was 88%, the probability of RR less than 0.67 was 0%, the probability of ARR of 2% or more was 78%, and the probability of ARR of 20% or more was 0%. If the prior was informed by previous studies, the estimated RR was 0.71 (95% CrI, 0.55-0.94), the probability of RR less than 1 was 99%, the probability of RR less than 0.67 was 48%, the probability of ARR of 2% or more was 98%, and the probability of ARR of 20% or more was 4%. CONCLUSIONS AND RELEVANCE: Post hoc Bayesian analysis of data from a randomized clinical trial of early extracorporeal membrane oxygenation compared with conventional lung-protective ventilation with the option for rescue extracorporeal membrane oxygenation among patients with very severe acute respiratory distress syndrome provides information about the posterior probability of mortality benefit under a broad set of assumptions that may help inform interpretation of the study findings.
Summary Objective To examine published evidence on the psychometric properties of the Epworth sleepiness scale (ESS) for describing the level of daytime sleepiness (DS) in adults. Methods Articles ...were located on MEDLINE and EMBASE. Psychometric properties were appraised using the COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) checklist. Results We found thirty-five studies evaluating psychometric properties of the ESS in adults. Of these, 27 studies examined construct validity, 14 – known-group validity, 8 – internal consistency and 4 – test–retest reliability. Study quality ranged from excellent to poor the majority being fair. Internal consistency by Cronbach's alphas was good (0.73–0.86). There is little available evidence on test–retest reliability. Pooled correlations of the ESS with other constructs varied: from moderate (the maintenance of wakefulness test; ρ = −0.43), to weak (the multiple sleep latency test; ρ = −0.27, and sleep apnea-related variables; ρ from 0.11 to 0.23). Although ESS scores varied significantly across groups of subjects with known differences in DS, not all differences were clinically important. Conclusion There have been relatively few high quality studies on the ESS psychometric properties. The internal consistency of the ESS suggests that this instrument can be recommended for group but not individual-level comparisons. Correlations with other measures of DS were stronger than with sleep apnea-related or general health measures, but still lower than expected. Further studies are required in the areas of test–retest reliability of the ESS.
A challenge to the use of observational data to study treatment effects is the issue of confounding. Noncomparability of exposed and nonexposed subjects can lead to biased estimation of the treatment ...effect. The propensity score is a balancing score that can be used to form matched groups, or pairs, that are not systematically different and enable nonbiased comparisons between groups. This article reviews propensity score methods with an illustrative example of the application of propensity score matching in an observational study of an uncommon disease (systemic sclerosis).
Obstructive sleep apnea (OSA) has been reported to be a risk factor for cardiovascular (CV) disease. Although the apnea-hypopnea index (AHI) is the most commonly used measure of OSA, other less well ...studied OSA-related variables may be more pathophysiologically relevant and offer better prediction. The objective of this study was to evaluate the relationship between OSA-related variables and risk of CV events.
A historical cohort study was conducted using clinical database and health administrative data. Adults referred for suspected OSA who underwent diagnostic polysomnography at the sleep laboratory at St Michael's Hospital (Toronto, Canada) between 1994 and 2010 were followed through provincial health administrative data (Ontario, Canada) until May 2011 to examine the occurrence of a composite outcome (myocardial infarction, stroke, congestive heart failure, revascularization procedures, or death from any cause). Cox regression models were used to investigate the association between baseline OSA-related variables and composite outcome controlling for traditional risk factors. The results were expressed as hazard ratios (HRs) and 95% CIs; for continuous variables, HRs compare the 75th and 25th percentiles. Over a median follow-up of 68 months, 1,172 (11.5%) of 10,149 participants experienced our composite outcome. In a fully adjusted model, other than AHI OSA-related variables were significant independent predictors: time spent with oxygen saturation <90% (9 minutes versus 0; HR = 1.50, 95% CI 1.25-1.79), sleep time (4.9 versus 6.4 hours; HR = 1.20, 95% CI 1.12-1.27), awakenings (35 versus 18; HR = 1.06, 95% CI 1.02-1.10), periodic leg movements (13 versus 0/hour; HR = 1.05, 95% CI 1.03-1.07), heart rate (70 versus 56 beats per minute bpm; HR = 1.28, 95% CI 1.19-1.37), and daytime sleepiness (HR = 1.13, 95% CI 1.01-1.28).The main study limitation was lack of information about continuous positive airway pressure (CPAP) adherence.
OSA-related factors other than AHI were shown as important predictors of composite CV outcome and should be considered in future studies and clinical practice.
Celotno besedilo
Dostopno za:
DOBA, IZUM, KILJ, NUK, PILJ, PNG, SAZU, SIK, UILJ, UKNU, UL, UM, UPUK
Background Health care systems provide care to increasingly complex and elderly patients. Colorectal surgery is a prime example, with high volumes of major procedures, significant morbidity, ...prolonged hospital stays, and unplanned readmissions. This situation is exacerbated by an exponential rise in costs that threatens the stability of health care systems. Enhanced recovery pathways (ERP) have been proposed as a means to reduce morbidity and improve effectiveness of care. We have reviewed the evidence supporting the implementation of ERP in clinical practice. Methods Medline, Embase, and the Cochrane library were searched for randomized, controlled trials comparing ERP with traditional care in colorectal surgery. Systematic reviews and papers on ERP based on data published in major surgical and anesthesiology journals were critically reviewed by international contributors, experienced in the development and implementation of ERP. Results A random-effect Bayesian meta-analysis was performed, including 6 randomized, controlled trials totalizing 452 patients. For patients adhering to ERP, length of stay decreased by 2.5 days (95% credible interval CrI −3.92 to −1.11), whereas 30-day morbidity was halved (relative risk, 0.52; 95% CrI, 0.36–0.73) and readmission was not increased (relative risk, 0.59; 95% CrI, 0.14–1.43) when compared with patients undergoing traditional care. Conclusion Adherence to ERP achieves a reproducible improvement in the quality of care by enabling standardization of health care processes. Thus, while accelerating recovery and safely reducing hospital stay, ERPs optimize utilization of health care resources. ERPs can and should be routinely used in care after colorectal and other major gastrointestinal procedures.
Echocardiography is important for the diagnosis of infective endocarditis (IE), for which transesophageal echocardiography (TEE) is superior to transthoracic echocardiography (TTE).
A systematic ...review and meta-analysis of observational studies was performed with the objective of evaluating diagnostic properties of TTE, with transesophageal findings of IE as the reference standard in patients with suspected IE.
The literature search yielded 377 unique articles, of which 16 met the inclusion criteria. The 16 studies included 2,807 patients, of whom 793 (28%) had vegetations on TEE. For detecting vegetations, harmonic TTE had sensitivity of 61% (95% CI, 45%-75%) and specificity of 94% (95% CI, 85%-98%) with a negative likelihood ratio (NLR) of 0.42 (95% CI, 0.26-0.61). NLR for harmonic TTE can be improved by including only patients without prosthetic valves (NLR = 0.36; 95% CI, 0.22-0.55) or by having strict criteria for conclusively negative results on TTE (NLR = 0.17; 95% CI, 0.10-0.28). In the setting of patients without prosthetic valves, harmonic TTE had likelihood ratios of 0.14 (95% CI, 0.09-0.23) for a conclusively negative result, 0.66 (95% CI, 0.53-0.81) for an indeterminate result, and 14.60 (95% CI, 3.37-70.40) for a positive result.
Modern harmonic TTE still has the potential to miss many vegetations detected on TEE. When limited to patients without prosthetic valves, a conclusively negative TTE under optimal view greatly decreases likelihood of IE. All other transthoracic results are not useful for ruling out IE, and subsequent TEE is almost always required.
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