Background Critical limb ischemia (CLI) represents the most severe clinical manifestation of peripheral arterial disease (PAD) and is the major cause of ischemic amputation in the United States. Risk ...factors and the associated incidence and prevalence of CLI have not been well described in the general population. This study describes the risk factors for PAD progression to CLI and estimates the annual incidence and prevalence of CLI in a representative United States patient cohort. Methods This was a retrospective cohort analysis of adults with commercial, Medicare supplemental, or Medicaid health insurance who had at least one PAD or CLI health care claim from January 1, 2003, through December 31, 2008, and 12 months of continuous coverage. Two subgroups of CLI presentation were identified: primary CLI (patients without any prior PAD or subsequent PAD diagnostic code >30 days after CLI diagnostic code) and secondary CLI (patients with prior PAD or subsequent PAD diagnostic codes ≤30 days of a CLI diagnostic code). Patterns of presentation, annual incidence, and prevalence of CLI were stratified by health care plan. Risk factors for progression to CLI were compared by presentation type. Results From 2003 to 2008, the mean annual incidence of PAD was 2.35% (95% confidence interval CI, 2.34%-2.36%) and the incidence of CLI was 0.35% (95% CI, 0.34%-0.35%) of the eligible study population, with primary and secondary presentations occurring at similar rates. The mean annualized prevalence of PAD was 10.69% (95% CI, 10.67%10.70%) and the mean annualized prevalence of CLI was 1.33% (95% CI, 1.32%-1.34%) of the eligible study population, and two-thirds of the cases presented as secondary CLI. CLI developed in 11.08% (95% CI, 11.30%-11.13%) of patients with PAD. A multivariable model demonstrated that diabetes, heart failure, stroke, and renal failure were stronger predictors of primary rather than secondary CLI presentation. Conclusions These data establish new national estimates of the incidence and prevalence of CLI and define key risk factors that contribute to primary or secondary presentations of CLI within a very large contemporary insured population cohort in the United States.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
...this analysis4 provides data that should dispel the myth that peripheral artery disease, as a disease of the aged, is confined to high-income countries (HIC).
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UL, UM, UPCLJ, UPUK
Meta-analysis collects and synthesizes results from individual studies to estimate an overall effect size. If published studies are chosen, say through a literature review, then an inherent selection ...bias may arise, because, for example, studies may tend to be published more readily if they are statistically significant, or deemed to be more "interesting" in terms of the impact of their outcomes. We develop a simple rank-based data augmentation technique, formalizing the use of funnel plots, to estimate and adjust for the numbers and outcomes of missing studies. Several nonparametric estimators are proposed for the number of missing studies, and their properties are developed analytically and through simulations. We apply the method to simulated and epidemiological datasets and show that it is both effective and consistent with other criteria in the literature.
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BFBNIB, CEKLJ, GIS, IJS, INZLJ, KISLJ, NMLJ, NUK, PNG, SAZU, UL, UM, UPUK, ZRSKP
We study recently developed nonparametric methods for estimating the number of missing studies that might exist in a meta‐analysis and the effect that these studies might have had on its outcome. ...These are simple rank‐based data augmentation techniques, which formalize the use of funnel plots. We show that they provide effective and relatively powerful tests for evaluating the existence of such publication bias. After adjusting for missing studies, we find that the point estimate of the overall effect size is approximately correct and coverage of the effect size confidence intervals is substantially improved, in many cases recovering the nominal confidence levels entirely. We illustrate the trim and fill method on existing meta‐analyses of studies in clinical trials and psychometrics.
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BFBNIB, FZAB, GIS, IJS, INZLJ, KILJ, NLZOH, NMLJ, NUK, OILJ, PNG, SAZU, SBCE, SBMB, UL, UM, UPUK, ZRSKP
Nontraumatic lower-extremity amputation is a devastating complication of peripheral artery disease (PAD) with a high mortality and medical expenditure. There are ≈150 000 nontraumatic leg amputations ...every year in the United States, and most cases occur in patients with diabetes. Among patients with diabetes, after an ≈40% decline between 2000 and 2009, the amputation rate increased by 50% from 2009 to 2015. A number of evidence-based diagnostic and therapeutic approaches for PAD can reduce amputation risk. However, their implementation and adherence are suboptimal. Some racial/ethnic groups have an elevated risk of PAD but less access to high-quality vascular care, leading to increased rates of amputation. To stop, and indeed reverse, the increasing trends of amputation, actionable policies that will reduce the incidence of critical limb ischemia and enhance delivery of optimal care are needed. This statement describes the impact of amputation on patients and society, summarizes medical approaches to identify PAD and prevent its progression, and proposes policy solutions to prevent limb amputation. Among the actions recommended are improving public awareness of PAD and greater use of effective PAD management strategies (eg, smoking cessation, use of statins, and foot monitoring/care in patients with diabetes). To facilitate the implementation of these recommendations, we propose several regulatory/legislative and organizational/institutional policies such as adoption of quality measures for PAD care; affordable prevention, diagnosis, and management; regulation of tobacco products; clinical decision support for PAD care; professional education; and dedicated funding opportunities to support PAD research. If these recommendations and proposed policies are implemented, we should be able to achieve the goal of reducing the rate of nontraumatic lower-extremity amputations by 20% by 2030.
Cigarette smoking increases the risk of coronary heart disease, but whether smoking increases atrial fibrillation (AF) is uncertain.
The purpose of this study was to determine the association of ...cigarette smoking with incident AF in a population-based cohort of blacks and whites.
We determined the risk of incident AF through December 2002 in relation to baseline (1987-1989) smoking status and cigarette-years of smoking in over 15,000 participants of the prospective Atherosclerosis Risk in Communities (ARIC) study.
Over a mean follow-up of 13.1 years, 876 incident AF events were identified. Compared to never smokers, the multivariable-adjusted hazard ratios (HRs) for AF were 1.32 (95% confidence interval CI 1.10-1.57) in former smokers, 2.05 (95% CI 1.71-2.47) in current smokers, and 1.58 (95% CI 1.35-1.85) in ever smokers. In the highest tertile of accumulated smoking amount (>675 cigarette-years), the incidence of AF was 2.10 times greater (95% CI 1.74-2.53) than in those who never smoked. Associations were similar by gender, race, type of event (AF and atrial flutter), and when only AF events identified by study exam ECGs were included. Finally, individuals who quit smoking exhibited a trend indicating a slightly lower risk of developing AF (HR 0.88, 95% CI 0.65-1.17) compared to those who continued to smoke.
Smoking was associated with the incidence of AF, with more than a two-fold increased risk of AF attributed to current smoking. In addition, a trend toward a lower incidence of AF appeared among smokers who quit compared to continued smokers.
While existing reviews have identified significant predictors of nursing home admission, this meta-analysis attempted to provide more integrated empirical findings to identify predictors. The present ...study aimed to generate pooled empirical associations for sociodemographic, functional, cognitive, service use, and informal support indicators that predict nursing home admission among older adults in the U.S.
Studies published in English were retrieved by searching the MEDLINE, PSYCINFO, CINAHL, and Digital Dissertations databases using the keywords: "nursing home placement," "nursing home entry," "nursing home admission," and "predictors/institutionalization." Any reports including these key words were retrieved. Bibliographies of retrieved articles were also searched. Selected studies included sampling frames that were nationally- or regionally-representative of the U.S. older population.
Of 736 relevant reports identified, 77 reports across 12 data sources were included that used longitudinal designs and community-based samples. Information on number of nursing home admissions, length of follow-up, sample characteristics, analysis type, statistical adjustment, and potential risk factors were extracted with standardized protocols. Random effects models were used to separately pool the logistic and Cox regression model results from the individual data sources. Among the strongest predictors of nursing home admission were 3 or more activities of daily living dependencies (summary odds ratio OR = 3.25; 95% confidence interval CI, 2.56-4.09), cognitive impairment (OR = 2.54; CI, 1.44-4.51), and prior nursing home use (OR = 3.47; CI, 1.89-6.37).
The pooled associations provided detailed empirical information as to which variables emerged as the strongest predictors of NH admission (e.g., 3 or more ADL dependencies, cognitive impairment, prior NH use). These results could be utilized as weights in the construction and validation of prognostic tools to estimate risk for NH entry over a multi-year period.
Introduction
Approximately 11.1 million cancer survivors are alive in the United States. Activity prescriptions for cancer survivors rely on evidence as to whether exercise during or after treatment ...results in improved health outcomes. This systematic review and meta-analysis evaluates the extent to which physical activity during and post treatment is appropriate and effective across the cancer control continuum.
Methods
A systematic quantitative review of the English language scientific literature searched controlled trials of physical activity interventions in cancer survivors during and post treatment. Data from 82 studies were abstracted, weighted mean effect sizes (WMES) were calculated from 66 high quality studies, and a systematic level of evidence criteria was applied to evaluate 60 outcomes. Reports of adverse events were abstracted from all studies.
Results
Quantitative evidence shows a large effect of physical activity interventions post treatment on upper and lower body strength (WMES = 0.99 & 0.90,
p
< 0.0001 & 0.024, respectively) and moderate effects on fatigue and breast cancer-specific concerns (WMES = −0.54 & 0.62,
p
= 0.003 & 0.003, respectively). A small to moderate positive effect of physical activity during treatment was seen for physical activity level, aerobic fitness, muscular strength, functional quality of life, anxiety, and self-esteem. With few exceptions, exercise was well tolerated during and post treatment without adverse events.
Conclusions
Current evidence suggests many health benefits from physical activity during and post cancer treatments. Additional studies are needed in cancer diagnoses other than breast and with a focus on survivors in greatest need of improvements for the health outcomes of interest.
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EMUNI, FIS, FZAB, GEOZS, GIS, IJS, IMTLJ, KILJ, KISLJ, MFDPS, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, SBMB, SBNM, UKNU, UL, UM, UPUK, VKSCE, ZAGLJ
BACKGROUND—Thymosin β4 (Tβ4) has been shown to enhance the survival of cultured cardiomyocytes. Here, we investigated whether the cytoprotective effects of Tβ4 can increase the effectiveness of ...transplanted swine mesenchymal stem cells (sMSCs) for cardiac repair in a rat model of myocardial infarction (MI).
METHODS AND RESULTS—Under hypoxic conditions, cellular damage (lactate dehydrogenase leakage), apoptosis (terminal deoxynucleotidyl transferase dUTP nick end labelingc cells), and caspase-8 activity were significantly lower, whereas B-cell lymphoma-extra large protein expression was significantly higher, in sMSCs cultured with Tβ4 (1 μg/mL) than in sMSCs cultured without Tβ4, and Tβ4 also increased sMSC proliferation. For in vivo experiments, animals were treated with basal medium (MIn=6), a fibrin patch (Patchn=6), a patch containing sMSCs (sMSCn=9), or a patch containing sMSCs and Tβ4 (sMSC/Tβ4n=11); Tβ4 was encapsulated in gelatin microspheres to extend Tβ4 delivery. Four weeks after treatment, echocardiographic assessments of left-ventricular ejection fraction and fractional shortening were significantly better (P<0.05) in sMSC/Tβ4 animals (left-ventricular ejection fraction=51.7±1.1%; fractional shortening=26.7±0.7%) than in animals from MI (39±3%; 19.5±1.7%) and Patch (43±1.4%; 21.6±0.9%) groups. Histological assessment of infarct wall thickness was significantly higher (P<0.05) in sMSC/Tβ4 animals (50%, 45%, 80%) than in animals from MI (25%, 20%, 25%) group. Measurements in sMSC (left-ventricular ejection fraction=45±2.6%; fractional shortening=22.9±1.6%; TH=43% 25%, 45%), Patch, and MI animals were similar. Tβ4 administration also significantly increased vascular growth, the retention/survival of the transplanted sMSCs, and the recruitment of endogenous c-Kit progenitor cells to the infarcted region.
CONCLUSIONS—Extended-release Tβ4 administration improves the retention, survival, and regenerative potency of transplanted sMSCs after myocardial injury.
Objective To determine whether isoflavones exert estrogen-like effects in men by lowering bioavailable T through evaluation of the effects of soy protein or isoflavone intake on T, sex ...hormone–binding globulin (SHBG), free T, and free androgen index (FAI) in men. Design PubMed and CAB Abstracts databases were searched through July 1, 2008, with use of controlled vocabulary specific to the databases, such as soy, isoflavones, genistein, phytoestrogens, red clover, androgen, testosterone, and SHBG . Peer-reviewed studies published in English were selected if 1 adult men consumed soy foods, isolated soy protein, or isoflavone extracts (from soy or red clover) and 2 circulating T, SHBG, free T, or calculated FAI was assessed. Data were extracted by two independent reviewers. Isoflavone exposure was abstracted directly from studies. Main Outcome Measure(s) Fifteen placebo-controlled treatment groups with baseline and ending measures were analyzed. In addition, 32 reports involving 36 treatment groups were assessed in simpler models to ascertain the results. Result(s) No significant effects of soy protein or isoflavone intake on T, SHBG, free T, or FAI were detected regardless of statistical model. Conclusion(s) The results of this meta-analysis suggest that neither soy foods nor isoflavone supplements alter measures of bioavailable T concentrations in men.
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GEOZS, IJS, IMTLJ, KILJ, KISLJ, NLZOH, NUK, OILJ, PNG, SAZU, SBCE, SBJE, UILJ, UL, UM, UPCLJ, UPUK, ZAGLJ, ZRSKP
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