Tag: statistics

Heart Vessels. 2022 Jan 1. doi: 10.1007/s00380-021-02003-w. Online ahead of print.

ABSTRACT

In patients undergoing percutaneous coronary intervention (PCI) with a stent, high on-treatment platelet reactivity may be associated with an increased risk of stroke. This post hoc analysis of the PENDULUM registry compared the risk of post-PCI stroke according to on-treatment P2Y₁₂ reaction unit (PRU) values. Patients aged ≥ 20 years who underwent PCI were stratified by baseline PRU (at 12 and 48 h post-PCI) as either high (HPR, > 208), optimal (OPR, > 85 to ≤ 208), or low on-treatment platelet reactivity (LPR, ≤ 85). The incidences of non-fatal ischemic and non-ischemic stroke through to 12 months post-PCI were recorded. Almost all enrolled patients (6102/6267 [97.4%]) had a risk factor for ischemic stroke, and most were receiving dual antiplatelet therapy. Of the 5906 patients with PRU data (HPR, n = 2227; OPR, n = 3002; LPR, n = 677), 47 had a non-fatal stroke post-PCI (cumulative incidence: 0.68%, ischemic; 0.18%, non-ischemic stroke). Patients with a non-fatal ischemic stroke event had statistically significantly higher post-PCI PRU values versus those without an event (P = 0.037). The incidence of non-fatal non-ischemic stroke was not related to PRU value. When the patients were stratified by PRU ≤ 153 versus > 153 at 12-48 h post-PCI, a significant difference was observed in the cumulative incidence of non-fatal stroke at 12 months (P = 0.044). We found that patients with ischemic stroke tended to have higher PRU values at 12-48 h after PCI versus those without ischemic stroke.Clinical trial registration: UMIN000020332.

PMID:34973085 | DOI:10.1007/s00380-021-02003-w

Int Urogynecol J. 2022 Jan 1. doi: 10.1007/s00192-021-05029-w. Online ahead of print.

ABSTRACT

INTRODUCTION AND HYPOTHESIS: The aim of this prospective study was to examine the impact of sociodemographic, pregnancy and obstetric characteristics on sexual function 12 months postpartum in primiparous women. We hypothesized that sexual function would decrease after childbirth.

METHODS: Between 1 October 2014 and 1 October 2017, all nulliparous women in early pregnancy registering for maternity health care in Region Örebro County, Sweden, were invited to participate in this prospective study. A total of 958 women were included. Sexual activity and function were measured at early pregnancy, 8 weeks postpartum and 12 months postpartum using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12). The associations between sociodemographic, pregnancy and obstetric characteristics and sexual activity and function from early pregnancy to 12 months postpartum were examined using linear and logistic models based on generalized estimating equations.

RESULTS: We found that the prevalence of sexually active women decreased from 98.0% in early pregnancy to 66.7% at 8 weeks postpartum, but increased to 90.0% at 12 months postpartum. Age ≥ 35 years, second-degree perineal tear and current breastfeeding were statistically significant risk factors for sexual inactivity at 12 months postpartum. Poor self-reported health in early pregnancy was statistically significantly associated with decreased sexual function at 12 months postpartum.

CONCLUSIONS: A majority of women resumed sexual activity at 8 weeks postpartum and most women at 12 months postpartum; the decrease in sexual function at 12 months postpartum was small and few risk factors were observed.

PMID:34973088 | DOI:10.1007/s00192-021-05029-w

Arch Womens Ment Health. 2022 Jan 1. doi: 10.1007/s00737-021-01185-6. Online ahead of print.

ABSTRACT

The objective of this analysis was to determine if there are sex differences with esketamine for treatment-resistant depression (TRD). Post hoc analyses of three randomized, controlled studies of esketamine in patients with TRD (TRANSFORM-1, TRANSFORM-2 [18-64 years], TRANSFORM-3 [≥ 65 years]) were performed. In each 4-week study, adults with TRD were randomized to esketamine or placebo nasal spray, each with a newly initiated oral antidepressant. Change from baseline to day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score was assessed by sex in pooled data from TRANSFORM-1/TRANSFORM-2 and separately in data from TRANSFORM-3 using a mixed-effects model for repeated measures. Use of hormonal therapy was assessed in all women, and menopausal status was assessed in women in TRANSFORM-1/TRANSFORM-2. Altogether, 702 adults (464 women) received ≥ 1 dose of intranasal study drug and antidepressant. Mean MADRS total score (SD) decreased from baseline to day 28, more so among patients treated with esketamine/antidepressant vs. antidepressant/placebo in both women and men: TRANSFORM-1/TRANSFORM-2 women-esketamine/antidepressant -20.3 (13.19) vs. antidepressant/placebo -15.8 (14.67), men-esketamine/antidepressant -18.3 (14.08) vs. antidepressant/placebo -16.0 (14.30); TRANSFORM-3 women-esketamine/antidepressant -9.9 (13.34) vs. antidepressant/placebo -6.9 (9.65), men-esketamine/antidepressant -10.3 (11.96) vs. antidepressant/placebo -5.5 (7.64). There was no significant sex effect or treatment-by-sex interaction (p > 0.35). The most common adverse events in esketamine-treated patients were nausea, dissociation, dizziness, and vertigo, each reported at a rate higher in women than men. The analyses support antidepressant efficacy and overall safety of esketamine nasal spray are similar between women and men with TRD. The TRANSFORM studies are registered at clinicaltrials.gov (identifiers: NCT02417064 (first posted 15 April 2015; last updated 4 May 2020), NCT02418585 (first posted 16 April 2015; last updated 2 June 2020), and NCT02422186 (first posted 21 April 2015; last updated 29 September 2021)).

PMID:34973081 | DOI:10.1007/s00737-021-01185-6

Neurol Sci. 2022 Jan 1. doi: 10.1007/s10072-021-05758-2. Online ahead of print.

ABSTRACT

BACKGROUND: Nocebo effect is prevalent among neurological diseases, resulting in low adherence and treatment outcome. We sought to examine the nocebo effect in randomized controlled trials (RCTs) in multiple system atrophy (MSA).

METHODS: We searched RCTs in MSA from Medline since September, 2021. RCTs for drug treatment conducted in adult MSA patients with more than 5 cases in each treatment arm were included. We assessed the number of dropout due to placebo intolerance. We also did a symptomatic/disease-modifying subgroup analysis based on two different treatment purposes. The STATA software was used for statistical analysis. Overall heterogeneity was assessed using the Cochran Q and I².

RESULTS: Data were extracted from 11 RCTs fulfilling our search criteria. Of 540 placebo-treated patients, 64.2% reported at least one adverse event (AE) and 7.5% reported dropout because of AEs. The chance of dropping out because of an AE and experiencing at least one AE did not differ between placebo and active drug treatment arms. Besides, the pooled nocebo dropout rate in the symptomatic subgroup was similar to that of the disease-modifying subgroup.

CONCLUSION: In MSA RCTs, nocebo dropout rate was not at a low level among neurological disorders. Nocebo effect was an important reason of dropout because of AE in placebo and active drug treatment arms. Different treatment purposes may not influence nocebo effect.

PMID:34973075 | DOI:10.1007/s10072-021-05758-2

Clin Rheumatol. 2022 Jan 1. doi: 10.1007/s10067-021-05902-5. Online ahead of print.

ABSTRACT

To characterise gout patients at high risk of hospitalisation and to develop a web-based prognostic model to predict the likelihood of gout-related hospital admissions. This was a retrospective single-centre study of 1417 patients presenting to the emergency department (ED) with a gout flare between 2015 and 2017 with a 1-year look-back period. The dataset was randomly divided, with 80% forming the derivation and the remaining forming the validation cohort. A multivariable logistic regression model was used to determine the likelihood of hospitalisation from a gout flare in the derivation cohort. The coefficients for the variables with statistically significant adjusted odds ratios were used for the development of a web-based hospitalisation risk estimator. The performance of this risk estimator model was assessed via the area under the receiver operating characteristic curve (AUROC), calibration plot, and brier score. Patients who were hospitalised with gout tended to be older, less likely male, more likely to have had a previous hospital stay with an inpatient primary diagnosis of gout, or a previous ED visit for gout, less likely to have been prescribed standby acute gout therapy, and had a significant burden of comorbidities. In the multivariable-adjusted analyses, previous hospitalisation for gout was associated with the highest odds of gout-related admission. Early identification of patients with a high likelihood of gout-related hospitalisation using our web-based validated risk estimator model may assist to target resources to the highest risk individuals, reducing the frequency of gout-related admissions and improving the overall health-related quality of life in the long term. KEY POINTS : • We reported the characteristics of gout patients visiting a tertiary hospital in Singapore. • We developed a web-based prognostic model with non-invasive variables to predict the likelihood of gout-relatedhospital admissions.

PMID:34973076 | DOI:10.1007/s10067-021-05902-5

Environ Manage. 2022 Jan 1. doi: 10.1007/s00267-021-01559-7. Online ahead of print.

ABSTRACT

Natural ecosystems are fundamental to local water cycles and the water ecosystem services that humans enjoy, such as water provision, outdoor recreation, and flood protection. However, integrating ecosystem services into water resources management requires that they be acknowledged, quantified, and communicated to decision-makers. We present an indicator framework that incorporates the supply of, and demand for, water ecosystem services. This provides an initial diagnostic for water resource managers and a mechanism for evaluating tradeoffs through future scenarios. Building on a risk assessment framework, we present a three-tiered indicator for measuring where demand exceeds the supply of services, addressing the scope (spatial extent), frequency, and amplitude for which objectives (service delivery) are not met. The Ecosystem Service Indicator is measured on a 0-100 scale, which encompasses none to total service delivery. We demonstrate the framework and its applicability to a variety of services and data sources (e.g., monitoring stations, statistical yearbooks, modeled datasets) from case studies in China and Southeast Asia. We evaluate the sensitivity of the indicator scores to varying levels data and three methods of calculation using a simulated test dataset. Our indicator framework is conceptually simple, robust, and flexible enough to offer a starting point for decision-makers and to accommodate the evolution and expansion of tools, models and data sources used to measure and evaluate the value of water ecosystem services.

PMID:34973072 | DOI:10.1007/s00267-021-01559-7

Cardiovasc Intervent Radiol. 2022 Jan 1. doi: 10.1007/s00270-021-03023-9. Online ahead of print.

ABSTRACT

PURPOSE: To compare the safety and efficacy of left versus right internal jugular vein access for portal vein puncture during transjugular intrahepatic portosystemic shunt (TIPS) creation in patients with a small liver and short vertical puncture distance.

MATERIALS AND METHODS: The vertical distance from the hepatic vein orifice to the puncture point of the portal vein was measured by CT and DSA. A distance ≤ 30 mm is defined as a short vertical puncture distance. After 1:1 propensity score matching (PSM), 29 patients of left internal jugular vein-TIPS (LIJ-TIPS) and 29 patients of right internal jugular vein-TIPS (RIJ-TIPS) were included. The number of needle punctures, fluoroscopy time, and radiation dose during the puncture process were statistically analyzed.

RESULTS: There was no significant difference in the average vertical puncture distances on CT or DSA between LIJ-TIPS and RIJ-TIPS (19.10 ± 0.60 mm vs. 19.30 ± 0.60 mm, P = 0.840; 22.02 ± 0.69 mm vs. 22.23 ± 0.64 mm, P = 0.822, respectively). The average number of needle punctures, fluoroscopy time, and radiation dose in LIJ-TIPS were significantly lower than those in RIJ-TIPS (2.07 ± 0.20 vs. 4.10 ± 0.24, P < 0.001; 78.45 ± 12.80 s vs. 201.16 ± 23.71 s, P < 0.001; 31.55 ± 7.04 mGy vs. 136.69 ± 16.38 mGy, P < 0.001, respectively). Within three punctures, the technical success rate in LIJ-TIPS was significantly higher than that in RIJ-TIPS (86.2 vs. 27.6%, P < 0.001). The incidence of hemoperitoneum in LIJ-TIPS was significantly lower than that in RIJ-TIPS (0% vs. 13.8%, P = 0.038).

CONCLUSION: The left internal jugular vein could be used as primary access for TIPS creation in patients with a small liver and short vertical puncture distance.

PMID:34973068 | DOI:10.1007/s00270-021-03023-9

Intensive Care Med. 2022 Jan 1. doi: 10.1007/s00134-021-06597-7. Online ahead of print.

ABSTRACT

PURPOSE: The importance of dying with dignity in the intensive care unit (ICU) has been emphasized. The South Korean government implemented the “well-dying law” in 2018, which enables patients to refuse futile life-sustaining treatment (LST) after being determined as terminally ill. We aimed to study whether the well-dying law is associated with a significant change in the quality of death in the ICU.

METHODS: The Quality of Dying and Death (QODD) questionnaires were prospectively collected from the doctors and nurses of deceased patients of four South Korean medical ICUs after the law was passed (January 2019 to May 2020). Results were compared with those of our previous study, which used the same metric before the law was passed (June 2016 to May 2017). We compared baseline characteristics of the deceased patients, enrolled staff, QODD scores, and staff opinions about withdrawing LST from before to after the law was passed.

RESULTS: After the well-dying law was passed, deceased patients (N = 252) were slightly older (68.6 vs. 66.6, p = 0.03) and fewer patients were admitted to the ICU for post-resuscitation care (10.3% vs. 20%, p = 0.003). The mean total QODD score significantly increased after the law was passed (36.9 vs. 31.3, p = 0.001). The law had a positive independent association with the increased QODD score in a multiple regression analysis.

CONCLUSION: Our study is the first to show that implementing the well-dying law is associated with quality of death in the ICU, although the quality of death in South Korea remains relatively low and should be further improved.

PMID:34973069 | DOI:10.1007/s00134-021-06597-7

Eur J Nutr. 2022 Jan 1. doi: 10.1007/s00394-021-02728-4. Online ahead of print.

ABSTRACT

PURPOSE: In the Netherlands, voluntary fortification of foods with micronutrients is allowed under strict regulations. This study investigates the impact of voluntary food fortification practices in the Netherlands on the frequency and type of fortified food consumption and on the micronutrient intakes of the Dutch population.

METHODS: Data of the Dutch National Food Consumption Survey (2012-2016; N = 4314; 1-79 year) and the Dutch Food Composition Database (NEVO version 2016) was used. To determine if voluntary fortified foods could be classified as healthy foods, criteria of the Dutch Wheel of Five were used. Habitual intakes of users and non-users of voluntary food fortification were calculated using Statistical Program to Assess Dietary Exposure (SPADE) and compared.

RESULTS: Within the Dutch population, 75% could be classified as user of voluntary fortified foods. Consumed voluntary fortified foods were mostly within food groups ‘Fats and Oils’, ‘Non-alcoholic Beverages’ and ‘Dairy products and Substitutes’ and fell mostly outside the Wheel of Five. Voluntary foods contributed between 9 and 78% to total micronutrient intake of users. Users had up to 64% higher habitual micronutrient intakes, compared to non-users. These higher intakes resulted into lower risks on inadequate intakes, and did not contribute to increased risks of excessive intakes.

CONCLUSION: Although voluntary fortified foods increased micronutrient intakes, most of these foods cannot be classified as healthy foods. Future studies should study the association between higher micronutrient intakes and (potential) excessive intakes of e.g. saturated fat and sugar to better understand the role of voluntary fortified foods in a healthy food pattern.

PMID:34973066 | DOI:10.1007/s00394-021-02728-4

Eur J Nutr. 2022 Jan 1. doi: 10.1007/s00394-021-02757-z. Online ahead of print.

ABSTRACT

PURPOSE: In the Netherlands, margarines and other plant-based fats (fortified fats) are encouraged to be fortified with vitamin A and D, by a covenant between the Ministry of Health and food manufacturers. Frequently, these types of fats are also voluntarily fortified with other micronutrients. The current study investigated the contribution of both encouraged as well as voluntary fortification of fortified fats on the micronutrient intakes in the Netherlands.

METHODS: Data of the Dutch National Food Consumption Survey (2012-2016; N = 4, 314; 1-79 year.) and the Dutch Food Composition Database (NEVO version 2016) were used to estimate micronutrient intakes. Statistical Program to Assess Dietary Exposure (SPADE) was used to calculate habitual intakes and compared to dietary reference values, separate for users and non-users of fortified fats.

RESULTS: Of the Dutch population, 84% could be considered as user of fortified fats. Users consumed mostly 1 fortified fat a day, and these fats contributed especially to the total micronutrient intake of the encouraged fortified micronutrients (vitamins D and A; 44% and 29%, respectively). The voluntary fortification also contributed to total micronutrient intakes: between 7 and 32%. Vitamin D and A intakes were up to almost double among users compared to non-users. Intakes were higher among users for almost all micronutrients voluntarily added to fats. Higher habitual intakes resulted into higher risks of excessive vitamin A-intakes among boys and adult women users.

CONCLUSION: Consumption of fortified fats in the Netherlands resulted into higher vitamin A and D-intakes among users, compared to non-users of these products.

PMID:34973067 | DOI:10.1007/s00394-021-02757-z