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Nevin Manimala Statistics

Can we increase efficiency of CT lung cancer screening by combining with CVD and COPD screening? Results of an early economic evaluation

Eur Radiol. 2022 Jan 1. doi: 10.1007/s00330-021-08422-7. Online ahead of print.

ABSTRACT

OBJECTIVES: Estimating the maximum acceptable cost (MAC) per screened individual for low-dose computed tomography (LDCT) lung cancer (LC) screening, and determining the effect of additionally screening for chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD), or both on the MAC.

METHODS: A model-based early health technology assessment (HTA) was conducted to estimate whether a new intervention could be cost-effective by calculating the MAC at a willingness-to-pay (WTP) of €20k/quality-adjusted life-year (QALY) and €80k/QALY, for a population of current and former smokers, aged 50-75 years in The Netherlands. The MAC was estimated based on incremental QALYs gained from a stage shift assuming screened individuals are detected in earlier disease stages. Data were obtained from literature and publicly available statistics and validated with experts.

RESULTS: The MAC per individual for implementing LC screening at a WTP of €20k/QALY was €113. If COPD, CVD, or both were included in screening, the MAC increased to €230, €895, or €971 respectively. Scenario analyses assessed whether screening-specific disease high-risk populations would improve cost-effectiveness, showing that high-risk CVD populations were more likely to improve economic viability compared to COPD.

CONCLUSIONS: The economic viability of combined screening is substantially larger than for LC screening alone, primarily due to benefits from CVD screening, and is dependent on the target screening population, which is key to optimise the screening program. The total cost of breast and cervical cancer screening is lower (€420) than the MAC of Big-3, indicating that Big-3 screening may be acceptable from a health economic perspective.

KEY POINTS: • Once-off combined low-dose CT screening for lung cancer, COPD, and CVD in individuals aged 50-75 years is potentially cost-effective if screening would cost less than €971 per screened individual. • Multi-disease screening requires detailed insight into the co-occurrence of these diseases to identify the optimal target screening population. • With the same target screening population and WTP, lung cancer-only screening should cost less than €113 per screened individual to be cost-effective.

PMID:34973103 | DOI:10.1007/s00330-021-08422-7

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Nevin Manimala Statistics

Toward ‘seeing’ critically: a Bayesian analysis of the impacts of a critical pedagogy

Adv Health Sci Educ Theory Pract. 2022 Jan 1. doi: 10.1007/s10459-021-10087-2. Online ahead of print.

ABSTRACT

Critical reflection supports enactment of the social roles of care, like collaboration and advocacy. We require evidence that links critical teaching approaches to future critically reflective practice. We thus asked: does a theory-informed approach to teaching critical reflection influence what learners talk about (i.e. topics of discussion) and how they talk (i.e. whether they talk in critically reflective ways) during subsequent learning experiences? Pre-clinical students (n = 75) were randomized into control and intervention conditions (8 groups each, of up to 5 interprofessional students). Participants completed an online Social Determinants of Health (SDoH) module, followed by either: a SDoH discussion (control) or critically reflective dialogue (intervention). Participants then experienced a common learning session (homecare curriculum and debrief) as outcome assessment, and another similar session one-week later. Blinded coders coded transcripts for what (topics) was said and how (critically reflective or not). We constructed Bayesian regression models for the probability of meaning units (unique utterances) being coded as particular what codes and as critically reflective or not (how). Groups exposed to the intervention were more likely, in a subsequent learning experience, to talk in a critically reflective manner (how) (0.096 [0.04, 0.15]) about similar content (no meaningful differences in what was said). This difference waned at one-week follow up. We showed experimentally that a particular critical pedagogical approach can make learners’ subsequent talk, ways of seeing, more critically reflective even when talking about similar topics. This study offers the field important new options for studying historically challenging-to-evaluate impacts and supports theoretical assertions about the potential of critical pedagogies.

PMID:34973100 | DOI:10.1007/s10459-021-10087-2

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Factors affecting the quality of life of gastric cancer survivors

Support Care Cancer. 2022 Jan 1. doi: 10.1007/s00520-021-06683-y. Online ahead of print.

ABSTRACT

BACKGROUND: The number of gastric cancer survivors has been increasing, and such survivors experience various changes in their lives post-recovery. Adapting to these changes requires appropriate interventions that can improve their quality of life (QoL). This study was conducted to investigate the factors affecting the QoL of gastric cancer survivors and provide basic data for effective intervention.

METHODS: Data were collected between September 8 and September 29, 2017, from the Gastric Cancer Center at a tertiary hospital. Questionnaire surveys were conducted using the EORTC QLQ-C30/STO22, Self-Efficacy-Scale, Multidimensional Scale of Perceived Social Support, and Quality of Life-Cancer Survivors Questionnaire on gastric cancer survivors who were followed up for 3 years after gastrectomy. Data were analyzed using descriptive statistics, t test, ANOVA, Pearson’s correlation coefficient, and multiple regression analysis.

RESULTS: A total of 136 gastric cancer survivors completed the questionnaire survey. There were significant positive correlations of QoL with self-efficacy, functional status, and social support (r = .35, p < .001; r = .53, p < .001; r = .26, p < .001, respectively). There were significant negative correlations of QoL with general symptoms (r = – .39, p < .001) and gastric cancer-specific symptoms (r = – .51, p < .001). The regression model explained 48.3% of the QoL, and the affecting factors were gastric cancer-specific symptoms (β = – .397, p < .001), religious belief (β = .299, p < .001), functional status (β = .251, p = .003), and self-efficacy (β = .191, p = .004).

CONCLUSION: This study confirmed that gastric cancer-specific symptoms, spiritual well-being, self-efficacy, and functional status affect the QoL of gastric cancer survivors. Hence, these factors should be considered in the interventions to improve the QoL of gastric cancer survivors.

PMID:34973098 | DOI:10.1007/s00520-021-06683-y

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Nevin Manimala Statistics

Sexual function in primiparous women: a prospective study

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

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Nevin Manimala Statistics

Relationship between platelet aggregation and stroke risk after percutaneous coronary intervention: a PENDULUM analysis

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

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Efficacy and safety of esketamine nasal spray by sex in patients with treatment-resistant depression: findings from short-term randomized, controlled trials

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

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Nevin Manimala Statistics

Hospital admission risk stratification of patients with gout presenting to the emergency department

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

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Nevin Manimala Statistics

Nocebo effect in multiple system atrophy: systematic review and meta-analysis of placebo-controlled clinical trials

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

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Integrating Ecosystem Services Into Water Resource Management: An Indicator-Based Approach

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

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Nevin Manimala Statistics

Change in perception of the quality of death in the intensive care unit by healthcare workers associated with the implementation of the “well-dying law”

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