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Using the model to develop a mHealth intervention | We conducted the mHealth intervention programmes under the guidance of the conceptual framework. Also, we adopted the same conceptual framework to design the intervention strategies which were similar in the constructs but different in detailed content of care needs for the two groups of patients. Use of the conceptual framework to design the mHealth intervention for participants. | PMC10014612 | ||
Follow-up assessment | Follow-up assessments were performed at baseline and 12 weeks after enrollment based on intention-to-treat principles for participants. Each assessment included BP measurement using the provided wearable BP monitor, measurement of waist and hip circumference, height and weight, and questionnaire survey. | PMC10014612 | ||
Outcomes | The primary outcomes were change in SBP and DBP, and the co-primary outcomes were change in waist and hip circumference, height and weight. The second outcomes were change in self-reported CHPS, self-efficacy, and quality of life. | PMC10014612 | ||
Ethical consideration | RECRUITMENT | The study protocol was approved by the ethics committee of School of Health Sciences, Wuhan University in China (Ethical approval number: 2019YF2054). At the process of recruitment, clear explanations about the study objection were provided to all the participants and written informed consent was obtained. | PMC10014612 | |
Statistical analysis | hypertension | REGRESSION, SECONDARY, HYPERTENSION, CONCOMITANT DISEASE | According to the results of our protocol, after the mobile platform management, the BP compliance rate of patients was more than 70%. According to the epidemiological survey conducted by Lin (We sought to recruit at least 134 patients to have 90% power to detect a 5-mm Hg difference in SBP between treatment arms, with an α of 0.05.We conducted our analyses according to intention-to-treat principles. Means and frequencies of baseline characteristics were calculated between two group differences despite randomization. The primary outcomes and the secondary outcomes were analyzed using univariate linear regression models. We defined statistical significance as In subgroup analyses, we evaluated differential effects of the intervention on the outcomes with respect to gender, age, number of concomitant diseases, years of hypertension, baseline BMI, baseline hypertension compliance, baseline self-efficacy, and baseline SBP based on the statistical significance of the interaction term for the subgroup of interest in the multivariable model.All data analyses were conducted using SAS software (version 9.4). | PMC10014612 |
Results | PMC10014612 | |||
Participants | From Nov 2017 to Jul 2018, we screened 200 participants, of whom 148 met eligibility criteria and randomly divided into two equal groups. Eight participants from the intervention group and 6 participants from the control group were lost to follow-up because they could not attend the scheduled meetings despite being contacted by research personnel. Therefore, 66 patients in the intervention group and 68 in the control group completed the final assessment at 12 weeks and were included in the intention-to-treat analysis. | PMC10014612 | ||
Baseline characteristics | hypertension, HC | HYPERTENSION | Demographic and socioeconomic characteristics, systolic blood pressure (SBP), diastolic blood pressure (DBP), BMI, waist circumference (WC), hip circumference (HC), hypertension compliance, self-efficacy, physical health and mental health in the intervention group were similar to those of the control group participants (Sociodemographic characteristics of participants ( | PMC10014612 |
Blood pressure | hypertension | SECONDARY, HYPERTENSION, CONCOMITANT DISEASE | At baseline, the mean (SD) SBP was 152.59 (23.44) mmHg in the intervention group and 148.85 (20.70) mmHg among controls. After 12 weeks of follow-up, the mean (SD) SBP decreased by 8.52 (19.73) mmHg in the intervention group and by 1.25 (12.47) mmHg in the control group (between-group difference, −7.265 mm Hg; 95% CI, −12.89 to −1.64 mm Hg; Primary and secondary outcomes.Subgroup analyses of the association of the intervention with SBP by gender, age, number of concomitant diseases, years of hypertension, baseline BMI, baseline hypertension compliance and baseline self-efficacy showed no significant between-group differences, while was significant by baseline SBP ( | PMC10014612 |
Waist and hip circumference | At baseline, the mean (SD) WC was 91.42 (12.92) cm in the intervention group and 90.37 (9.45) cm in the control group. After 12 weeks of follow-up, the mean (SD) WC decreased by 2.14 (2.61) cm in the intervention group and by 0.25 (0.61) cm in the control group (between-group difference, −1.89 cm; 95% CI, −2.53 to −1.25 cm; | PMC10014612 | ||
Hypertension compliance | hypertension | HYPERTENSION, CONCOMITANT DISEASE | At baseline, the mean (SD) hypertension compliance was 46.70 (6.69) in the intervention group and 46.46 (6.89) among controls. After 12 weeks of follow-up, the mean (SD) hypertension compliance increased by 7.35 (7.31) in the intervention group and by 3.01 (4.92) in the control group (between-group difference, 4.334; 95% CI, 2.21 to −6.46; Subgroup analyses of the association of the intervention with hypertension compliance by gender, age, number of concomitant diseases, years of hypertension, baseline BMI, baseline self-efficacy and baseline SBP showed no significant between-group differences, while was significant by baseline hypertension compliance (Subgroup analyses of the difference between intervention and control from baseline to 12 weeks. | PMC10014612 |
Self-efficacy | hypertension | HYPERTENSION, CONCOMITANT DISEASE | At baseline, the mean (SD) self-efficacy was 59.21 (10.44) in the intervention group and 57.84 (11.71) among controls. After 12 weeks of follow-up, the mean (SD) hypertension compliance increased by 12.89 (11.95) in the intervention group and by 5.43 (10.54) in the control group (between-group difference, 7.47; 95% CI, 3.62 to 11.31; Subgroup analyses of the association of the intervention with self-efficacy by gender, age, number of concomitant diseases, years of hypertension, baseline BMI, baseline hypertension compliance and baseline SBP showed no significant between-group differences, while was significant by baseline self-efficacy ( | PMC10014612 |
Quality of life | hypertension | HYPERTENSION, CONCOMITANT DISEASE | At baseline, the mean (SD) physical health was 49.52 (10.10) in the intervention group and 49.59 (9.11) in the control group, and the mean (SD) mental health was 41.68 (9.39) in the intervention group and 40.12 (10.30) in the control group. After 12 weeks of follow-up, the mean (SD) physical health increased by 12.21 (10.77) in the intervention group and by 1.54 (7.18) in the control group (between-group difference, 10.66; 95% CI, 7.54 to 13.78; Subgroup analyses of the association of the intervention with mental health by age, number of concomitant diseases, years of hypertension, baseline BMI, baseline hypertension compliance, baseline self-efficacy, and baseline SBP showed no significant between-group differences, while was significant by gender ( | PMC10014612 |
Discussion | hypertension, cardiovascular disease | SECONDARY, HYPERTENSION, CARDIOVASCULAR DISEASE | To our knowledge, this study is the first randomized controlled trial to assess mHealth intervention to improve cardiovascular factors and promote healthier lifestyle behaviors among individuals at high risk of cardiovascular disease in low-resource rural settings in China. This study aimed to evaluate the effects of mobile phone-based intervention on BP control, waist and hip circumference, self-reported hypertension compliance, self-efficacy, and quality of life. Our findings show that compared with local usual primary care, mHealth BP monitoring intervention resulted in significant improvements in SBP and other cardiovascular factors. Compared with usual community-based management of hypertension patients, mHealth intervention patients had greater controlled SBP, waist and hip circumference. Moreover, the intervention also improved some aspects of self-reported hypertension compliance and self-efficacy, and appeared to have an acceptable level of quality of life.The results of this randomized control trial showed that the wearable BP wristband and app-based management could decreased SBP by 8.52 (19.73) mm Hg (95% CI, −12.89 to −1.64 mm Hg; Unique features of our study were the significant improvement in self-reported hypertension compliance and self-efficacy with corresponding reductions in SBP. In our study, readings from the home-based BP monitoring wearable devices were used to evaluate trial outcomes. A possible explanation might be that the reductions in BP from baseline to the 12 weeks of follow-up that we observed in both the control and intervention group were resulted from fluctuations in these home BP monitoring readings, and that the magnitude of these fluctuations was larger than the hypothesized effect from the smartphone application (It is interesting to note a net reduction in the waist circumference, while, no changes were seen in levels of hip circumference. It might be related to the amount of exposure to the intervention domains defined by the patients during motivational suggestion, following the autonomy support on the basis of principle. Thus, target behavior including reduction of high-sugar and high-fat foods intake was most commonly chosen during motivational home visit or counseling calls. In line with our findings, Partridge et al. (How could home-based BP monitoring wearable devices enhance the quality of life for patients with hypertension? While the wearable devices we tested has received high usability scores? It may be the reason that patients with hypertension in low-resource rural settings have needs that differ from those with other conditions (Several limitations should be considered of this trial. The sample size was small and included only 6 primary care centers, and excluded those had no smartphones, which may contributed discrepancies in participant baseline characteristics and lack of power to detect differences of the secondary and subgroup analyses outcomes between two groups. Also, the hypertension compliance, self-efficacy and SF-12 questionnaires were all self-reported measurements, therefore we cannot conclude the findings to a broader population. In addition, the trial was not double-blinded, which may lead to an effect on the reporting bias such as recall error, social desirability or other subjective outcomes. However, BP recordings were measured by automated wearable devices with a standard protocol, which was unlikely to have been biased. Lack of information on long-term intervention effects, reimbursement mechanisms, and return on investment have been revealed as barriers to trail implementation ( | PMC10014612 |
Conclusions | Despite the popularity of smartphone health-related apps has increased quickly, there has been a lack of rigorous studies which including a clinically important outcome ( | PMC10014612 | ||
Data availability statement | The original contributions presented in the study are included in the article/supplementary material, further inquiries can be directed to the corresponding author. | PMC10014612 | ||
Ethics statement | The studies involving human participants were reviewed and approved by the Ethics Committee of the School of Public Health, Wuhan University. The patients/participants provided their written informed consent to participate in this study. | PMC10014612 | ||
Author contributions | RECRUITMENT | ZY conceived the study and completed the original draft preparation. ZY and TX collected data. TX provided the recruitment resources. WQ reviewed, edited the final draft, and received the funding. All authors contributed to the article and approved the submitted version. | PMC10014612 | |
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10014612 | ||
Publisher's note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10014612 | ||
References | PMC10014612 | |||
Background and objective | CM, cutaneous melanoma, psoriasis | CUTANEOUS MELANOMA, PSORIASIS | Edited by: Giuseppe Murdaca, University of Genoa, ItalyReviewed by: Koshy Nithin Thomas, Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI), India; Masahiro Yoshikawa, Nihon University School of Medicine, Japan†These authors have contributed equally to this workExisting cross-sectional and retrospective studies were unable to establish a causal relationship between psoriasis and cutaneous melanoma (CM). We sought to evaluate the causal role between psoriasis and CM. | PMC10368886 |
Methods | CM, psoriasis | REGRESSION, PSORIASIS | We performed a bidirectional two-sample Mendelian randomization analysis using summary statistics from genome-wide association studies of psoriasis and CM among individuals of predominantly European ancestry. Mendelian randomization–Egger regression, inverse variance weighting, Mendelian Randomization Pleiotropy RESidual Sum and Outlier, weighted mode, and weighted median were used to examine the causal effect between psoriasis and CM. | PMC10368886 |
Results | CM, psoriasis | PSORIASIS | Genetically predicted psoriasis was a significant risk factor for CM (odds ratio, 1.69; 95% confidence interval, 1.15–2.48; P = 0.025). In contrast, no association was observed between genetically predicted CM and psoriasis. | PMC10368886 |
Conclusion | cutaneous melanoma, CM, psoriasis | CUTANEOUS MELANOMA, PSORIASIS | Our findings corroborated the existence of genetically predicted psoriasis increases risk of CM. Enhanced early screening of cutaneous melanoma in patients with psoriasis may improve clinical burden. However, we did not find evidence for a causal link from CM to psoriasis, so further studies are required to elucidate the effect of CM activity on psoriasis. | PMC10368886 |
Introduction | CM, psoriasis | MINOR, DISEASE, PSORIASIS | At present, there is controversy regarding whether the risk of CM in patients with psoriasis is higher than that in the general population (Traditional observational epidemiological studies face many challenges in discovering disease etiology and inferring causality, such as reverse causal associations, potential confounding factors, minor exposure factors, and multiple tests. In observational and retrospective cohort studies, it is difficult to explore a causal relationship between psoriasis and CM with the existence of treatment or other interfering factors beyond our control. Prospective randomized controlled trials or other research methods that can rule out these interfering factors are urgently needed to establish a causal relationship between psoriasis and CM.In recent years, with the continuous development of statistical methods, large-sample genome-wide association study (GWAS) data, epigenetics, and various “omics” techniques, the Mendelian randomization (MR) study design has been increasingly widely used in the discussion of the causal association between complex exposure factors and disease outcomes ( | PMC10368886 |
Materials and methods | PMC10368886 | |||
Data sources | cancers, CM, psoriasis | CANCERS, PSORIASIS | The GWAS summary statistics for psoriasis were derived from data published by FinnGen Consortium R9. This study used the “psoriasis” phenotype. The GWAS of psoriasis included 373,338 Finnish adult subjects, including 9,267 cases and 364,071 controls, which excluded subjects with other cancers. Age, sex, top 10 major components, and genotyping batches were corrected during analysis. As a genetic instrumental variable, the GWAS summary data of CM came from the two-stage genome-wide meta-analysis conducted by Matthew et al. ( | PMC10368886 |
Instrumental variable | We use the following five criteria to select instrumental variables (IV). First, the SNP–phenotype association level must reach a genome-wide significance threshold (P< 5*10 | PMC10368886 | ||
Statistical analysis | MR, CM, psoriasis | REGRESSION, PSORIASIS | In the present study, we evaluated the causal relationship between psoriasis and CM using various methods, including inverse variance weighting (IVW), MR–Egger regression, MR Pleiotropy RESidual Sum and Outlier (MR-PRESSO), weighted mode, and weighted median. IVW, also known as the inverse variance weighting method, is characterized by ignoring the existence of an intercept term in regression and using the reciprocal of outcome variance (seThe F statistic was calculated by the formula All analyses were performed in R (version 4.2.2; R Foundation for Statistical Computing, Vienna, Austria), and MR analysis was conducted based on the TwosampleMR ( | PMC10368886 |
Results | PMC10368886 | |||
Psoriasis to CM | CM, psoriasis | PSORIASIS | As shown in Instrumental variables used in MR analysis of the association between psoriasis and CM.MR analysis of the causal relationship between genetically predicted psoriasis and CM. Cochran’s IVW and MR–Egger Q test showed no significant heterogeneity among these IVs ( | PMC10368886 |
CM to psoriasis | CM, psoriasis | PSORIASIS | We obtained seven SNPs (P< 5 * 10MR analysis of the causal relationship between genetically predicted CM and psoriasis. | PMC10368886 |
Discussion | melanoma, human melanoma, CM, psoriasis | MELANOMA, PSORIASIS | To our knowledge, this study was the first attempt to explore the causal relationship between psoriasis and CM using the summary statistics of FinnGen Alliance R9 and the large GWAS meta-analysis conducted by Matthew et al. (Most current studies on the effect of psoriasis on CM are observational cross-sectional studies or retrospective cohort studies, with inconsistent findings. For instance, Egeberg et al.’s (NF-κB has pleiotropic properties in the surrounding environment, but three are its basic roles. First, it is involved in pro-inflammatory responses. In human melanoma, many NF-κB-regulated chemokines are expressed at high levels: CXCL8 or IL8, CXCL1 (melanoma growth-stimulating activity), CCL5 (regulatory activation, normal T expression and secretion), and CCL2 (In addition, studies on psoriasis risk in patients with CM are few and inconsistent. The retrospective cohort study of Sam et al. ( | PMC10368886 |
Strengths and limitations | MR, melanoma, CM, psoriasis | ERYTHRODERMIC PSORIASIS, PUSTULAR PSORIASIS, MELANOMA, PSORIASIS, ARTHRITIC PSORIASIS, PSORIASIS VULGARIS, PSORIATIC ARTHRITIS, REGRESSION | This study had several advantages. To determine the causal relationship between psoriasis and CM without the interference of confounding factors, we performed bidirectional MR analysis. Bidirectional Mendelian randomization analysis is an extension of standard Mendelian randomization analysis. Compared with the latter, the former can investigate whether there is a two-way causal relationship between exposure variables and outcome variables. In addition, genetic variation in CM was derived from the largest available GWAS meta-analysis, ensuring the strength of instruments in MR analyses. We detected and excluded horizontal poly-tropism using MR-PRESSO and MR–Egger regression intercept tests. Finally, there was no overlap between the GWAS summary data for psoriasis and the meta-analysis GWAS summary data for CM, which led to low heterogeneity, low bias, and high accuracy in our study.We also acknowledge some limitations. First, most of the data used in the analysis mainly came from individuals with European ancestry, which restricts the applicability of our findings to other ethnic groups. Second, due to the lack of detailed clinical data, we were unable to conduct a subgroup analysis, for example, to distinguish between psoriasis vulgaris, arthritic psoriasis, pustular psoriasis, and erythrodermic psoriasis; explore non-linear relationships; or to sort by the severity of psoriasis. A population-based study in Denmark suggested a modestly increased risk of melanoma in patients with mild psoriasis and no increased risk in patients with severe psoriasis and psoriatic arthritis ( | PMC10368886 |
Conclusion | cutaneous melanoma, CM, psoriasis | CUTANEOUS MELANOMA, PSORIASIS | Our results confirmed genetically predicted psoriasis increases risk of CM. Enhanced early screening of cutaneous melanoma in patients with psoriasis may improve clinical burden. In addition, although the reverse MR estimation does not support the causal relationship from CM to psoriasis, it cannot be ruled out that CM has an effect on the incidence of psoriasis; further research is needed to confirm this. | PMC10368886 |
Data availability statement | The original contributions presented in the study are included in the article/ | PMC10368886 | ||
Ethics statement | We did not need further ethical approval for this study because we used data from published studies that had the appropriate ethics committees’ approval. | PMC10368886 | ||
Author contributions | NZ: Conceptualization, Methodology, Software, Investigation, Visualization, Writing an original draft. PG: Methodology, Investigation. MT: Investigation, experiment. FY: Methodology, Investigation. TZ: Data Provision, Methodology. RM: Conceptualization, Writing - original draft, Funding acquisition, Supervision. All authors contributed to the article and approved the submitted version. | PMC10368886 | ||
Acknowledgments | We thank all the researchers for providing their GWAS data. We also thank the participants and researchers of the FinnGen study. | PMC10368886 | ||
Conflict of interest | The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. | PMC10368886 | ||
Publisher’s note | All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article, or claim that may be made by its manufacturer, is not guaranteed or endorsed by the publisher. | PMC10368886 | ||
Supplementary material | The Supplementary Material for this article can be found online at: Click here for additional data file. | PMC10368886 | ||
References | PMC10368886 | |||
Background | sepsis, ARDS | SECONDARY, CRITICAL ILLNESS, SEPSIS, ARDS, ACUTE RESPIRATORY DISTRESS SYNDROME | Two acute respiratory distress syndrome (ARDS) trials showed no benefit for statin therapy, though secondary analyses suggest inflammatory subphenotypes may have a differential response to simvastatin. Statin medications decrease cholesterol levels, and low cholesterol has been associated with increased mortality in critical illness. We hypothesized that patients with ARDS and sepsis with low cholesterol could be harmed by statins.
| PMC10053133 |
Methods | sepsis, Sepsis, ARDS | ACUTE RESPIRATORY DISTRESS SYNDROME, SEPSIS, REGRESSION, SEPSIS, ARDS | Secondary analysis of patients with ARDS and sepsis from two multicenter trials. We measured total cholesterol from frozen plasma samples obtained at enrollment in Statins for Acutely Injured Lungs from Sepsis (SAILS) and Simvastatin in the Acute Respiratory Distress Syndrome (HARP-2) trials, which randomized subjects with ARDS to rosuvastatin versus placebo and simvastatin versus placebo, respectively, for up to 28 days. We compared the lowest cholesterol quartile (< 69 mg/dL in SAILS, < 44 mg/dL in HARP-2) versus all other quartiles for association with 60-day mortality and medication effect. Fisher’s exact test, logistic regression, and Cox Proportional Hazards were used to assess mortality. | PMC10053133 |
Results | Sequential Organ Failure, sepsis, shock | SEPSIS, SHOCK | There were 678 subjects with cholesterol measured in SAILS and 509 subjects in HARP-2, of whom 384 had sepsis. Median cholesterol at enrollment was 97 mg/dL in both SAILS and HARP-2. Low cholesterol was associated with higher APACHE III and shock prevalence in SAILS, and higher Sequential Organ Failure Assessment score and vasopressor use in HARP-2. Importantly, the effect of statins differed in these trials. In SAILS, patients with low cholesterol who received rosuvastatin were more likely to die (odds ratio (OR) 2.23, 95% confidence interval (95% CI) 1.06–4.77, | PMC10053133 |
Conclusions | sepsis-related ARDS | Cholesterol levels are low in two cohorts with sepsis-related ARDS, and those in the lowest cholesterol quartile are sicker. Despite the very low levels of cholesterol, simvastatin therapy seems safe and may reduce mortality in this group, though rosuvastatin was associated with harm. | PMC10053133 | |
Graphical abstract | PMC10053133 | |||
Supplementary Information | The online version contains supplementary material available at 10.1186/s13054-023-04387-9. | PMC10053133 | ||
Keywords | PMC10053133 | |||
Background | ARDS | ACUTE RESPIRATORY DISTRESS SYNDROME, CRITICAL ILLNESS, ARDS | Acute respiratory distress syndrome (ARDS) is a heterogeneous condition with high mortality and lacks targeted medical therapies [Interestingly, the effect of statin medications on lipid profiles as it pertains to outcomes in critical illness has not been well studied. Cholesterol has proposed roles in normal lung physiology, including its integration into surfactant and delivery of the antioxidant Vitamin E to type II pneumocytes [Cholesterol synthesis is downregulated in critical illness by multiple mechanisms, including pro-inflammatory cytokines which affect transcription of cholesterol products [The present study investigates the effect of total cholesterol levels on response to statin therapy in ARDS using data from the SAILS and HARP-2 trials. First, we hypothesized that subjects with lower baseline cholesterol would have higher mortality than those with higher cholesterol, and second that randomization to statin therapy could be harmful in this high-risk subgroup. | PMC10053133 |
Methods | PMC10053133 | |||
Population | Sepsis, ARDS | SEPSIS, SECONDARY, ARDS | This is a secondary analysis of randomized clinical trial data from the ARDS Network Statins for Acutely Injured Lungs from Sepsis (SAILS) trial [ | PMC10053133 |
Cholesterol measurement | Total cholesterol levels were obtained from frozen plasma samples which were collected at the time of enrollment in the clinical trials. Total cholesterol was measured in the year 2016 for SAILS samples using the Infinity Cholesterol Liquid Stable Reagent (TR2242, from ThermoFisher), and the Amplex Red Cholesterol Assay (A12216, from ThermoFisher) was used for HARP-2 samples in 2020. | PMC10053133 | ||
Statistical analysis | non-sepsis, sepsis-induced ARDS, illness, ARDS | REGRESSION, SECONDARY, ARDS | To test our hypothesis that mortality would be higher in subjects with lower cholesterol who received a statin, individuals were assigned to a “low cholesterol” or “not-low cholesterol” group defined by lowest quartile of total cholesterol versus the remaining three quartiles. To our knowledge, there is no universally accepted definition of low total cholesterol. In 2018, the global age-standardized mean total cholesterol was 178 mg/dL (95% confidence interval 174–182 mg/dL) for women and 172 mg/dL (95% confidence interval 168–176 mg/dL) for men [Our primary outcome was mortality at 60 days in subjects with sepsis-induced ARDS (the primary outcome in SAILS). We first compared the lowest cholesterol quartile versus all other quartiles in both trials. Available illness severity indices at enrollment were compared using the Wilcoxon rank-sum test. The illness severity score for SAILS was APACHE III, while HARP-2 reported APACHE II and SOFA scores. Mortality at 60 days for those randomized to a statin was compared using Fisher’s exact test. We also compared mortality for subjects in the lowest quartile randomized to statin versus placebo using Fisher’s exact test. Sixty-day mortality was evaluated using logistic regression which included cholesterol (lowest quartile vs. others), randomization to statin, and their interaction term, controlling for age, gender and body mass index (BMI). These covariates were chosen because of impact on total cholesterol levels in general population data [The secondary outcomes included the same Fisher’s exact tests, survival analysis and logistic regression for mortality at 60 days described above, but applied to the entire HARP-2 cohort (given that HARP-2 enrolled subjects with non-sepsis etiologies of ARDS in contrast to only subjects with sepsis-induced ARDS in both trials for the primary outcome). Additionally, we examined the clinical characteristics of low cholesterol in subjects randomized to receive placebo in both trials. Wilcoxon rank-sum tests and Fisher’s exact tests were used for continuous and categorical variables, respectively. The placebo group was used to remove any effect of statin therapy on survival, instead investigating the impact of cholesterol level alone. We assessed mortality at 60 days for patients in the lowest cholesterol quartile versus the top three quartiles using Fisher’s exact test. To increase statistical power, we also evaluated 60-day mortality for all subjects in both trials with cholesterol levels available.A sensitivity analysis was conducted with several additional thresholds for low cholesterol, and these results are presented in Additional file All data analysis was completed with R Studio, Version 1.2. | PMC10053133 |
Results | PMC10053133 | |||
Population | sepsis, pneumonia, infections, ARDS | SEPSIS, ARDS, PNEUMONIA, INFECTIONS | Of the 745 subjects enrolled in SAILS, 678 subjects had sufficient plasma samples available to obtain baseline total cholesterol levels, and thus were included in this analysis. In the SAILS trial, the predominant cause of sepsis-associated ARDS was pneumonia, with the remaining cases largely consisting of other infections and aspiration. Median total cholesterol was low in this cohort, 97 mg/dL (IQR 69–130), with the lowest quartile defined by total cholesterol < 69 mg/dL.Our analysis of the HARP-2 cohort included 509 subjects from whom cholesterol levels were attainable, including 384 subjects with sepsis. The most common etiologies of ARDS in the entire cohort were identified as pneumonia and sepsis. Median total cholesterol levels for all patients in HARP-2 were also low, 97 mg/dL (IQR 44–168), with the lowest quartile defined by total cholesterol < 44 mg/dL. These values were not significantly different when calculated for all 509 HARP2 subjects versus only the 384 with sepsis (data not shown). | PMC10053133 |
Association of low cholesterol with illness severity and mortality | sepsis | SEPSIS | As shown in Table Baseline characteristics of SAILS and HARP-2 cohorts stratified by cholesterol level* Shock/vasopressor requirement was significantly higher in low cholesterol group in both cohorts(Only HARP-2 patients with sepsis are includedValues are presented as | PMC10053133 |
Discussion | illness, sepsis, high-density lipoprotein reduction, ARDS | HYPOCHOLESTEREMIA, SIDE EFFECT, SECONDARY, SEPSIS, ARDS | This study first investigated the association between total cholesterol levels with mortality and secondly the response to statin therapy in patients with ARDS and sepsis through a secondary analysis of the SAILS and HARP-2 trials. These cohorts had remarkably low baseline cholesterol levels, and low cholesterol correlated with increased illness severity in both cohorts. Subjects with lower cholesterol had higher mortality when randomized to receive rosuvastatin in the SAILS cohort. In contrast, fewer patients with sepsis and ARDS with low cholesterol randomized to simvastatin died in the HARP-2 trial compared to those who received placebo, though this did not reach statistical significance.Median cholesterol level in our subsets with sepsis was 97 mg/dL in both SAILS and HARP-2, but perhaps more striking were the extreme values seen in the lowest quartile of total cholesterol, defined by < 69 mg/dL and < 44 mg/dL respectively. Higher rates of shock/vasopressor use are noted in HARP-2, which may indicate greater illness severity and thus contribute to the lower cholesterol levels seen in this trial. Reduced vascular tone has previously been associated with hypocholesteremia; however, the mechanism is not fully understood [The direction of effect of statin therapy on mortality differed, with rosuvastatin associated with increased mortality in patients with low cholesterol, while simvastatin non-significantly decreased mortality in the same subset. This discrepancy between the trials might be due to differences in the properties and doses of these two statins. Rosuvastatin (administered at a daily dose of 20 mg in SAILS) was selected for SAILS because of its lower side effect profile and reduced incidence of drug-drug interactions. However, simvastatin (administered at a daily dose of 80 mg in HARP-2) had been previously proposed as a superior statin medication for ARDS and sepsis despite its lower potency as a lipid-lowering agent (rosuvastatin 10 mg is equivalent to simvastatin 72 mg and 77 mg for low-density and high-density lipoprotein reduction, respectively) [Though the original SAILS and HARP-2 trials did not show benefit for either statin in the overall population studied, there remains interest in studying statins further in ARDS subphenotypes, given the encouraging data for simvastatin in highly inflamed subjects in particular [Our study has methodological strengths, including the inclusion of two independent randomized, controlled trial cohorts, which allows assessment of statin impact in a low cholesterol group without concern for confounding. Because the statin medications utilized in SAILS and HARP-2 were different, we have been able to capture within-class differences in effects of statin medications in ARDS. While the association between low cholesterol and bad outcomes in sepsis has been reported, consideration of total cholesterol as a potential predictor of response to statins has not been studied before in ARDS to our knowledge, and helps inform an area with plausible biological relevance.This study also has some weaknesses. First, despite including large RCT data, there was insufficient power to detect mortality differences which could be clinically significant. However, several models confirmed the mortality differences reported for low cholesterol subjects by treatment arm, and our observations of increased illness severity in low cholesterol subjects were also statistically significant by multiple tests. Secondly, the threshold for the lowest quartile differed in SAILS and HARP-2, and we did not define an optimal cholesterol threshold in this study. Third, cholesterol was not measured on fresh samples, but on stored aliquots years after study completion, and using two different assays for the two trials. We do note that our median values were similar not only to each other, but also to those described in the ANZ-STATInS trial [ | PMC10053133 |
Conclusions | illness, ARDS | ARDS | In conclusion, absolute values of cholesterol are low in these two ARDS cohorts, and the lowest levels of cholesterol are associated with greater severity of illness. There were differential effects of rosuvastatin and simvastatin in ARDS subjects with low cholesterol. We found rosuvastatin was associated with higher mortality in this subgroup, though simvastatin seems safe in these patients. Patients with low total cholesterol should be included in future trials of simvastatin as a treatment in ARDS. | PMC10053133 |
Acknowledgements | Not applicable. | PMC10053133 | ||
Author contributions | CMO | SMP, MAM, RMB, DFM, CMO, and AJR collaborated in conception of this study. JG and JC performed data acquisition. SMP, ARM, and AJR performed the data analysis. SMP and AJR were primarily responsible for drafting of the work, and all authors participated in revision and approval of the final draft. All authors read and approved the final manuscript | PMC10053133 | |
Funding | ARDS | LUNG, BLOOD, HEART, ARDS | NIH/NHLBI R01 HL112747, HL111024, HL51856, HL55330, Global Research Laboratory grant, NIH/NCATS KL2-TR-002385. The SAILS trial was conducted by the ARDS Network and supported by a grant from the National Heart, Lung, and Blood Institute, National Institutes of Health (HHSN268200 536165C-536179C), and the Investigator-Sponsored Study Program of AstraZeneca, The HARP-2 trial was supported by the UK EME Programme, an MRC and NIHR partnership (08/99/08); by a Health Research Award (HRA_POR-2010-131) from the Health Research Board, Dublin; and by additional funding from the HSC Research and Development Division, Public Health Agency for Northern Ireland, the Intensive Care Society of Ireland, and REVIVE. | PMC10053133 |
Availability of data and materials | MAY, THORACIC | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. Data from this article have been presented in part at the American Thoracic Society Conference in 2020 (May 15–20, 2020) [ | PMC10053133 | |
Declarations | PMC10053133 | |||
Ethics approval and consent to participate | ARDS | SECONDARY, ARDS | The SAILS clinical trial (ClinicalTrials.gov Identifier: NCT00979121, accepted September 16, 2009) was approved by the Institutional Review Board at each of the 44 enrolling hospitals in the NHLBI ARDS Clinical trial network, and assent for participation was collected from patients and their families as part of SAILS trial enrollment at all centers. The HARP-2 trial (International Standard Registered Clinical Trial Number: 88244364) was approved by a national research ethics committee (approval August 9, 2010, ref: 10/NIR02/36) and by the research governance department at each study site in the United Kingdom and by the institutional research ethics committee at each study site in Ireland. All the patients or their representatives provided written informed consent or assent at all centers of both trials, including consent to use biospecimens for future research for subjects included in this analysis. Ethical approval for this analysis for the HARP-2 trial was granted by Queen’s University Belfast School Research Ethics Committee (ref. 14/06). Both studies were conducted in accordance with institutional ethical standards and as described by the Declaration of Helsinki. The Stanford Institutional Review Board waived monitoring for this secondary analysis. | PMC10053133 |
Consent for publication | Not applicable. | PMC10053133 | ||
Competing interests | The authors declare that they have no competing interests. | PMC10053133 | ||
References | PMC10053133 | |||
Background | Central venous catheter | Central venous catheter (CVC) insertion using simulation is an essential skill for anesthesiologists. Simulation training is an effective mean to master this skill. Given the large number of residents and the limited duration of training sessions, the active practice time is limited and residents remain observers of their colleagues for much of the session. To improve learning during observation periods, the use of an observer tool (OT) has been advocated but its educational effectiveness is not well defined. | PMC10714635 | |
Methods | COMPLICATIONS | Incoming anesthesia residents were randomized to use an OT (i.e. procedural skill-based checklist) (OT+) or not (OT-) when observing other residents during a simulation bootcamp. The primary outcome was a composite score (total 60 points) evaluating CVC procedural skills rated immediately after the training. This score covers theoretical knowledge explored by multiple choice questions (MCQs) (/20), perceived improvement in knowledge and skills (/20), perceived impact on future professional life (/10) and satisfaction (/10). Measurements were repeated 1 month later. Residents in each group recorded the number of CVCs placed and their clinical outcomes (attempts, complications) during the first month of their clinical rotation using a logbook. | PMC10714635 | |
Results | COMPLICATIONS | Immediately after training, the composite score was similar between the two groups: 45.3 ± 4.2 (OT+, Analysis of the logbook showed no difference between groups. No serious complications were reported. | PMC10714635 | |
Conclusions | The use of a procedural task-based OT by incoming anesthesia residents and used during CVC insertion simulation training was not associated with better learning outcomes, neither immediately after the session nor when re-evaluated 1 month later. The training at least once on simulator of all residents could limit the impact of OT. Further studies are necessary to define the place of OT in simulation training. | PMC10714635 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12909-023-04915-9. | PMC10714635 | ||
Keywords | PMC10714635 | |||
Background | Learning how to insert a central venous catheter (CVC) is essential for anesthesia residents and the use of simulation is recommended [The social learning theory proposed by Bandura and adapted to simulation states that vicarious learning occurs when observing others, one gets an idea of how behaviors are produced and how to reproduce them [To increase the positive effects of simulation training when the learner is in the role of observer, some authors have proposed the use of an observer tool (OT) allowing observers to analyze the progress of the task performed by their colleagues [The objective of this procedural simulation study was to assess whether the use of an OT improves learning experience of CVC placement in a simulation environment. | PMC10714635 | ||
Methods | PMC10714635 | |||
Study description | This prospective and randomized study was conducted at the simulation center of Paris-Saclay University (LabForSIMS). Approval had been obtained from the Research Ethics Committee of the French Society of Anesthesia and Intensive Care Medicine (SFAR, CERAR: IRB 00010254–2021 – 196). The trial has been registered on ClinicalTrials.gov (Identifier: NCT05134818; 26/11/2021). The study was carried out with the use of the CONSORT tool adapted for simulation studies [The training took place at the beginning of the first semester rotation during an initial training seminar (bootcamp) that is made mandatory for all incoming residents of the Paris area. The simulation session was preceded by a flipped classroom learning part (educational documents sent upstream including a video [After obtaining informed consent, residents were included (Fig. Study flow chartThe OT has been adapted from a previously published checklist [ | PMC10714635 | ||
Assessment method | failure or complications | PNEUMOTHORAX | The primary outcome was a composite learning score [Secondary outcomes included a separate analysis of each item of the composite score. During the first month of their clinical rotation, each resident recorded in a logbook the number of CVCs inserted (all access types), specifically those placed in the internal IJV. For the first insertion in the IJV, they had to report the number of attempts, insertion failure or complications (pneumothorax, arterial puncture, others) (levels 3 and 4 of the Kirkpatrick model [A reminder was sent every 2 weeks to encourage recording of clinical data and a medical book was offered as incentive to each resident who had fully completed the final questionnaire. | PMC10714635 |
Statistical analysis | Assuming that an expected mean composite score would be 48 out of 60 in the control group, using a standard deviation of 6 points out of 60, and considering that an improvement of one standard deviation (difference accepted for studies in education [The composite score was compared immediately after training between the two groups (i.e., OT+ versus OT-). Secondary outcomes were analyzed by comparing the two groups immediately after training and 1 month after training.Results are presented as mean ± standard deviation or percentage. Statistical analysis was carried out with JMP® software (Cary, NC 27513–2414, USA). Statistical comparisons used two-tailed Student’s t-test and analysis of variance for parametric and continuous variables, a Chi-square test for proportions, and a Wilcoxon test for non-parametric variables. A value of | PMC10714635 | ||
Results | PMC10714635 | |||
Inclusion | In November 2021, 96 anesthesia residents participated in the study and were included (Fig. Characteristics of participantsSignificant if Each resident was an active participant at least once and observed the performance of their peers six times (according to the mean number of residents in each group). | PMC10714635 | ||
Internal jugular vein (IJV) catheter insertion during clinical practice | During the first month, residents in the two groups had inserted a similar number of IJV catheters: 2.9 ± 1.7 and 3.4 ± 2 respectively (OT+: Number of CVC placed during the first month after training in the two groupsSignificant if Outcomes related to the first internal jugular catheters placed in clinical practice after the training session. Significant if Significant if | PMC10714635 | ||
Discussion | RECRUITMENT, DECAY | In this study, an observer tool (OT), based on chronological technical steps, was used with the aim of improving the training of incoming anesthesia residents to place a central venous catheter (internal jugular vein) during a simulation session. The use of an OT was not associated with better learning outcomes, immediately after the session and on reassessment, 1 month later.As learning from observing is likely more limited than active participation during simulation sessions [The absence of benefit reported in our present study could be explained by the fact that all the residents (with or without OT) had performed the task at least once on the task simulator. This active practice might have already improved their baseline skills (active education) thereby reducing the impact of the OT. Comparing groups of observers with or without OT but not practicing on the simulator might have potentiated the difference but ethical considerations precluded using this design. It is also possible that OT have differential impact based on clinical circumstances. They may be more appropriate for situations in which technical and non-technical skills are trained together [The available literature regarding the use of tools to increase observer learning is limited [Retention at 1 month was not only similar between groups but also similar to initial results. A similar number of procedures performed over the next month may explain this result. Comparing early and delayed results also revealed no difference. This was expected not only because trainees placed several CVCs during the following month, but also because the time interval was likely too short to identify any decay in knowledge. Any difference could also have been masked by the limited number of residents filling adequately their logbook, reducing the statistical power. We anticipated limited protocol compliance and therefore offered a well-known anesthesia book as incentive to complete the whole study. Offering a material or financial incentive is a well-known factor that can increase recruitment [Transfer of learning (i.e. levels 3 and 4 of the Kirkpatrick model [The strengths of this study included the fact that our study was prospective and randomized and that we used a previously validated CVC insertion grid [However, it also has several limitations. All participating residents (with or without OT) performed at least one CVC placement on the simulator during the session and this may have masked any additional effects of the tool.The use of a composite score to assess learning might have limited the validity of our results. However, this score has been used in one of our previous studies [ | PMC10714635 | |
Conclusion | An observer tool based on the technical steps needed to be performed when placing an internal jugular vein central catheter was used during training of incoming anesthesia residents during a simulation session but was not associated with better learning outcomes immediately after and 1 month later. Further studies are necessary to define the place of observer tools in medical education. | PMC10714635 | ||
Acknowledgements | We would like to acknowledge the technicians of LabForSIMS simulation center (B Bech and A Renault) who were of great help in preparing and managing the sessions and all the instructors who were involved in the training sessions. The authors would also like to thank Prof. Patrice Forget, MD, PhD, Clinical Chair (full professor) in Anaesthesia, University of Aberdeen and Honorary Consultant, NHS Grampian Aberdeen, United Kingdom and Prof. Romain Pirracchio, MD MPH, PhD, Ronald D Miller Distinguished Professor of Anesthesia and Perioperative Medicine, Professor of Anesthesia and Critical Care Medicine, Professor of Biostatistics, University of California San Francisco (UCSF) who edited the revised manuscript. | PMC10714635 | ||
Authors’ contributions | DB and AB designed the study, ST, BG, YB, LR, KK, CD, BJ, MBL, DB and AB performed the inclusion. ST and AB analyzed and interpreted the data. DB and AB wrote the main manuscript text. All authors reviewed the manuscript. | PMC10714635 | ||
Funding | Not applicable. | PMC10714635 | ||
Availability of data and materials | The datasets generated during and/or analyzed during the current study are available in the | PMC10714635 | ||
Declarations | PMC10714635 | |||
Ethics approval and consent to participate | This study was approved by the Ethical Committee for Research of the French Society of Anesthesia and Intensive Care Medicine (SFAR, CERAR: IRB 00010254–2021 – 196). All participants gave written informed consent. All methods were performed in accordance with the relevant guideline and regulation. | PMC10714635 | ||
Consent for publication | Not applicable. | PMC10714635 | ||
Competing interests | The authors declare no competing interests | PMC10714635 | ||
References | PMC10714635 | |||
Background | This study aimed to assess the effects of health education and community-level participatory interventions at the community level and the use of community maternal health promoters on the utilization of maternal health care services in poor rural settings of northern Ghana. | PMC10403908 | ||
Methods | REGRESSION | A randomized controlled survey design was conducted from June 2019 to July 2020 in two rural districts of northern Ghana. A multistage cluster sampling technique was used to select the participants. Data were collected from a repeated cross-sectional household survey. Descriptive analysis, bivariate and covariates adjusted simple logistic regression analyses were performed using STATA version 16 statistical software. | PMC10403908 | |
Results | At post-intervention, the two groups differed significantly in terms of ANC (p = 0.001), skilled delivery (SD) (p = 0.003), and PNC (p < 0.0001). Women who received health education on obstetric danger signs had improved knowledge by 50% at the end of the study. Women who received the health education intervention (HEI) on practices related to ANC and skilled delivery had increased odds to utilize ANC (AOR = 4.18; 95% CI = 2.48–7.04) and SD (AOR = 3.90; 95% CI = 1.83–8.29) services. Institutional delivery and PNC attendance for at least four times significantly increased from 88.5 to 97.5% (p < 0.0001), and 77.3–96.7% (p < 0.0001) respectively at postintervention. Women who had received the HEI were significantly more likely to have good knowledge about obstetric danger signs (AOR = 10.17; 95% CI = 6.59–15.69), and BPCR (AOR = 2.10; 95% CI = 1.36–3.24). Women who had obtained tertiary education were significantly more likely to make at least four visits to ANC (AOR = 2.38; 95% CI = 0.09–1.67). | PMC10403908 | ||
Conclusions | This study suggests that the use of health education and participatory sessions led by community-based facilitators could be a potentially effective intervention to improve the knowledge of women about obstetric danger signs and encourage the uptake of maternity care services in resource-poor settings of Ghana. | PMC10403908 | ||
Supplementary Information | The online version contains supplementary material available at 10.1186/s12889-023-16376-2. | PMC10403908 |
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