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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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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

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

Single-Centre Retrospective Study Using Propensity Score Matching Comparing Left Versus Right Internal Jugular Vein Access for Transjugular Intrahepatic Portosystemic Shunt (TIPS) Creation

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

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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

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Contribution of voluntary fortified foods to micronutrient intake in The Netherlands

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

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Nevin Manimala Statistics

Contribution of fortified margarines and other plant-based fats to micronutrient intake in the Netherlands

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

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Nevin Manimala Statistics

Research utility of a CAPS-IV and CAPS-5 hybrid interview: Posttraumatic stress symptom and diagnostic concordance in recent-era U.S. veterans

J Trauma Stress. 2021 Dec 31. doi: 10.1002/jts.22771. Online ahead of print.

ABSTRACT

The Clinician-Administered PTSD Scale (CAPS) is used to measure posttraumatic stress symptoms (PTSS) and diagnose posttraumatic stress disorder (PTSD). However, its use, particularly in settings involving longitudinal assessment, has been complicated by changes in the diagnostic criteria between the fourth and fifth editions of the Diagnostic and Statistical Manual of Mental Disorders (i.e., DSM-IV and DSM-5, respectively). The current sample included trauma-exposed U.S. veterans who were deployed in support of military operations following the September 11, 2001, terrorist attacks (N = 371) and were enrolled in a longitudinal study focused on deployment-related stress and traumatic brain injury. A hybrid clinical interview using item wording from the CAPS for DSM-IV (CAPS-IV) with the addition of items unique to the CAPS for DSM-5 (CAPS-5) was used to assess both DSM-IV and DSM-5 PTSD diagnostic criteria, allowing for the calculation of separate total scores and diagnoses. Diagnostic agreement, sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and interrater reliability between CAPS-IV and CAPS-5 were evaluated for the entire sample and stratified by gender. We found high diagnostic agreement (92.9%-95.4%), sensitivity (94.4%-98.2%), specificity (91.7%-92.8%), PPV (89.5%-93.0%), NPV (95.7%-98.1%), and interrater reliability,κ = 0.86-0.91,) for both men and women. The current study supports the use of a hybrid PTSD diagnostic interview assessing both DSM-IV and DSM-5 diagnostic criteria, particularly in situations such as longitudinal studies that may require a feasible method of incorporating changes in diagnostic criteria from the DSM-IV to the DSM-5.

PMID:34973042 | DOI:10.1002/jts.22771

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Nevin Manimala Statistics

An investigation of internalized stigma and recovery levels of patients registered in a Community Mental Health Center

Perspect Psychiatr Care. 2021 Dec 31. doi: 10.1111/ppc.13011. Online ahead of print.

ABSTRACT

AIM: This study was carried out to investigate the internalized stigma and recovery levels of patients registered in a Community Mental Health Center (CMHC).

MATERIAL AND METHODS: This descriptive study was completed with 230 psychiatric patients to a registered Community Mental Health Center is located in Turkey. Data were collected using a sociodemographic characteristics’ form, the Internalized Stigma of Mental Illness Scale (ISMI), and the Maryland Assessment of Recovery in Serious Mental Illness (MARS).

RESULTS: A statistically significant negative relationship was found between total ISMI and MARS scores (p < 0.05).

CONCLUSION: The internalized stigma and recovery levels of individuals diagnosed with mental illness registered at the CMHC were found to be normal.

PMID:34973035 | DOI:10.1111/ppc.13011

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Nevin Manimala Statistics

Change in posttraumatic stress disorder-related thoughts during treatment: Do thoughts drive change when pills are involved?

J Trauma Stress. 2021 Dec 31. doi: 10.1002/jts.22762. Online ahead of print.

ABSTRACT

Posttraumatic negative thoughts about one’s self and the world are related to posttraumatic stress disorder (PTSD) symptom severity and change in cognitive behavioral treatment (CBT), but little is known about this association when CBT is delivered with medication. The current study presents a planned comparison of changes in negative posttraumatic thoughts during (a) prolonged exposure (PE) plus pill placebo (PE+PLB), (b) sertraline plus enhanced medication management (SERT+EMM), and (c) PE plus sertraline (PE+SERT) as part of a randomized clinical trial in a sample of 176 veterans. Lagged regression modeling revealed that change in posttraumatic negative thoughts was associated with PTSD symptom change in the conditions in which participants received sertraline, ds = 0.14-0.25, ps = 0.04-.001). However, contrary to previous research, the models that started with symptom change were also statistically significant, d = 0.23, p < .001, for the lagged effect of symptoms on negative thoughts about self in the SERT+EMM condition, indicating a bidirectional association between such thoughts and PTSD symptoms. In the PE+PLB condition, no significant association between posttraumatic thoughts and PTSD symptoms emerged in either direction. These results suggest that the previously demonstrated role of change in posttraumatic thoughts leading to PTSD symptom reduction in PE may be altered when combined with pill administration, either active or placebo.

PMID:34973039 | DOI:10.1002/jts.22762