Effect size quantification for interrupted time series analysis: implementation in R and analysis for Covid-19 research

Decision letter: Direct and indirect mortality impacts of the COVID-19 pandemic in the United States, March 1, 2020 to January 1, 2022

Editor's evaluation: Direct and indirect mortality impacts of the COVID-19 pandemic in the United States, March 1, 2020 to January 1, 2022

Systemic corticosteroids for the treatment of COVID-19: Equity-related analyses and update on evidence.

Rapid fluid removal during dialysis is associated with cardiovascular morbidity and mortality

Symptomatic peripheral arterial disease (PAD) has several treatment options, including angioplasty, stenting, exercise therapy, and bypass surgery. Atherectomy is an alternative procedure, in which atheroma is cut or ground away within the artery. This is the first update of a Cochrane Review published in 2014. To evaluate the effectiveness of atherectomy for peripheral arterial disease compared to other established treatments. The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and Allied and Complementary Medicine (AMED) databases, and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 12 August 2019. We included all randomised controlled trials that compared atherectomy with other established treatments. All participants had symptomatic PAD with either claudication or critical limb ischaemia and evidence of lower limb arterial disease. Two review authors screened studies for inclusion, extracted data, assessed risk of bias and used GRADE criteria to assess the certainty of the evidence. We resolved any disagreements through discussion. Outcomes of interest were: primary patency (at six and 12 months), all-cause mortality, fatal and non-fatal cardiovascular events, initial technical failure rates, target vessel revascularisation rates (TVR; at six and 12 months); and complications. We included seven studies, with a total of 527 participants and 581 treated lesions. We found two comparisons: atherectomy versus balloon angioplasty (BA) and atherectomy versus BA with primary stenting. No studies compared atherectomy with bypass surgery. Overall, the evidence from this review was of very low certainty, due to a high risk of bias, imprecision and inconsistency. Six studies (372 participants, 427 treated lesions) compared atherectomy versus BA. We found no clear difference between atherectomy and BA for the primary outcomes: six-month primary patency rates (risk ratio (RR) 1.06, 95% confidence interval (CI) 0.94 to 1.20; 3 studies, 186 participants; very low-certainty evidence); 12-month primary patency rates (RR 1.20, 95% CI 0.78 to 1.84; 2 studies, 149 participants; very low-certainty evidence) or mortality rates (RR 0.50, 95% CI 0.10 to 2.66, 3 studies, 210 participants, very low-certainty evidence). One study reported cardiac failure and acute coronary syndrome as causes of death at 24 months but it was unclear which arm the participants belonged to, and one study reported no cardiovascular events. There was no clear difference when examining: initial technical failure rates (RR 0.48, 95% CI 0.22 to 1.08; 6 studies, 425 treated vessels; very low-certainty evidence), six-month TVR (RR 0.51, 95% CI 0.06 to 4.42; 2 studies, 136 treated vessels; very low-certainty evidence) or 12-month TVR (RR 0.59, 95% CI 0.25 to 1.42; 3 studies, 176 treated vessels; very low-certainty evidence). All six studies reported complication rates (RR 0.69, 95% CI 0.28 to 1.68; 6 studies, 387 participants; very low-certainty evidence) and embolisation events (RR 2.51, 95% CI 0.64 to 9.80; 6 studies, 387 participants; very low-certainty evidence). Atherectomy may be less likely to cause dissection (RR 0.28, 95% CI 0.14 to 0.54; 4 studies, 290 participants; very low-certainty evidence) and may be associated with a reduction in bailout stenting (RR 0.26, 95% CI 0.09 to 0.74; 4 studies, 315 treated vessels; very low-certainty evidence). Four studies reported amputation rates, with only one amputation event recorded in a BA participant. We used subgroup analysis to compare the effect of plain balloons/stents and drug-eluting balloons/stents, but did not detect any differences between the subgroups. One study (155 participants, 155 treated lesions) compared atherectomy versus BA and primary stenting, so comparison was extremely limited and subject to imprecision. This study did not report primary patency. The study reported one death (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence) and three complication events (RR 7.04, 95% CI 0.80 to 62.23; 155 participants; very low-certainty evidence) in a very small data set, making conclusions unreliable. We found no clear difference between the treatment arms in cardiovascular events (RR 0.38, 95% CI 0.04 to 3.23; 155 participants; very low-certainty evidence). This study found no initial technical failure events, and TVR rates at six and 24 months showed little difference between treatment arms (RR 2.27, 95% CI 0.95 to 5.46; 155 participants; very low-certainty evidence and RR 2.05, 95% CI 0.96 to 4.37; 155 participants; very low-certainty evidence, respectively). This review update shows that the evidence is very uncertain about the effect of atherectomy on patency, mortality and cardiovascular event rates compared to plain balloon angioplasty, with or without stenting. We detected no clear differences in initial technical failure rates or TVR, but there may be reduced dissection and bailout stenting after atherectomy although this is uncertain. Included studies were small, heterogenous and at high risk of bias. Larger studies powered to detect clinically meaningful, patient-centred outcomes are required.

Antithrombotic therapy for ambulatory patients with multiple myeloma receiving immunomodulatory agents.

Editorial: Special issue on time series analysis in the biological sciences

Dedication. Preface. Times Series Following Generalized Linear Models. Regression Models for Binary Time Series. Regression Models for Categorical Time Series. Regression Models for Count Time Series. Other Models and Alternative Approaches. State Space Models. Prediction and Interpolation. Appendix: Elements of Stationary Processes. References. Index.

Health hazards of obesity have been recognized for centuries, appearing, for example, in writings attributed to Hippocrates. From the later decades of the 20th century through the present, there have been numerous epidemiological studies of the relationship between excess weight and the total, or all-cause, mortality rate,1 a critical cumulative measure of the public health impact of any health condition. Using body mass index (BMI), an indicator of relative weight for height (weight [kg]/height [m]2) and a frequently used surrogate for assessment of excess body fat, these studies have found linear, U-shaped, or J-shaped relationships between total mortality and BMI. That is, in some studies, both the thin and the obese were more likely to die than those in between. There is, however, always a point at which increasing BMI is associated with increasing mortality risk, but the BMI at which this occurs varies across studies and populations.2 Currently,3 overweight in adults is defined as a BMI of 25.0 to <30.0 kg/m2 and obesity as a BMI of ≥30.0 kg/m2 (Table 1). A number of studies have found no significant relationship between BMI in the overweight range and mortality rate4 and have shown the nadir of mortality risk to be in the overweight range. In particular, commentaries in both the lay press5–7 and scientific literature2,8,9 subsequent to recent reports from National Health and Nutrition Examination Surveys (NHANES)10,11 have highlighted the confusion and controversy regarding this issue. Some have interpreted the recent data to mean that overweight is not detrimental to health and is not in itself a public health concern and that drawing attention to the need for weight loss in this range will have negative effects on the health and well-being of the general population.8 Others have argued …

PROTOCOL: Nutrition interventions and programs for reducing mortality and morbidity in pregnant and lactating women and women of reproductive age: a systematic review

In patients undergoing maintenance hemodialysis (MHD), increasing numbers of studies have reported a reduced mortality in patients with an increased body mass index (BMI). This article provides a meta-analysis on the assessment of the relationship between BMI and mortality in MHD patients. A systemic literature review was conducted to identify studies that examined all-cause mortality, with or without cardiovascular events, on the basis of bodyweight or obesity measures in MHD population published before October 2012. Eight observational studies with a total of 190,163 patients were included. Compared to the individuals with a normal BMI, overweight patients and obese patients were associated with lower all-cause mortality [relative risk (RR) 0.86, 95% confidence interval (CI) 0.84-0.88; RR 0.77, 95% CI 0.75-0.78, respectively] and cardiovascular mortality (RR 0.86; 95% CI 0.81-0.91; RR 0.78, 95% CI 0.73-0.83, respectively). Underweight patients had relatively higher all-cause and cardiovascular mortality (RR 1.22, 95% CI 1.20-1.25; RR 1.19, 95% CI 1.11-1.28, respectively). In an obesity-stratified analysis, the patients with moderate or severe obesity presented a strongly decreased all-cause mortality risk (RR 0.64, 95% CI 0.61-0.68) and cardiovascular mortality risk (RR 0.63, 95% CI 0.53-0.75) compared to patients with mild obesity (RR 0.74, 95% CI 0.71-0.77; RR 0.81, 95% CI 0.75-0.87, respectively). These findings show that overweight and obese patients have lower all-cause and cardiovascular mortality rates in patients undergoing MHD. Body weight management and optimized nutritional and metabolic support should help to reduce the high mortality rates that are prevalent in the hemodialysis population.

To systematically review and assess the relationship between particulate matter (PM(10) and PM(2.5)) and children's hospital admissions for asthma, using both time-series and case-crossover analyses. The PubMed, Ebsco, Ovid and four Chinese periodical databases were screened for studies related to short-term effects of particulate matter on pediatric asthma hospital admissions published from 1 January 1990 to 31 December 2013.Sixteen studies on PM(10) and 10 studies on PM(2.5) were selected finally for meta-analysis. Relative risk (RR) or odds ratio (OR) and 95% confidence intervals (CI) of asthma hospital admissions per 10 µg/m³ increase of daily particulate matter were obtained from each study. RevMan 5.2.11 was used to test the heterogeneity of the results among the different studies and amalgamat the effect size by fixed or random effect model. As the concentration of PM(10) increased per 10 µg/m³, the children's hospital admissions for asthma increased by 1.75%; for PM(2.5), a 3.45% increase for asthma hospital admissions as the concentration increased per 10 µg/m³. By subgroup analysis based on study design, the effect size on both PM(10) and PM(2.5) of case-crossover study's results were higher than time-series analysis. The short-term increase of the concentration of PM(10) and PM(2.5) may led to the increase of Children's hospital admissions for asthma, and PM(2.5) will present a higher risk contribution.

Oral Class I and III antiarrhythmic drugs for maintaining sinus rhythm a er catheter ablation of atrial fibrillation (Protocol).

To assess the e icacy and safety of nirmatrelvir/ritonavir (Paxlovid®) plus standard of care compared to standard of care with or without placebo, or any other proven intervention for treating COVID-19 and for preventing SARS-CoV-2 infection. Nirmatrelvir combined with ritonavir for preventing and treating COVID-19 (Protocol)

Prophylactic anticoagulants for non-hospitalised people with COVID-19.