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Nevin Manimala Statistics

Fragility index of trials supporting approval of anti-cancer drugs in common solid tumours

Cancer Treat Rev. 2021 Feb 16;94:102167. doi: 10.1016/j.ctrv.2021.102167. Online ahead of print.

ABSTRACT

BACKGROUND: The Fragility Indexquantifies the reliability of positive trials by estimating the number of events, which would change statistically significant results to non-significant results.

METHODS: We identified randomized trials supporting drug approvals by the US FDA between 2009 and 2019 in lung, breast, prostate, and colon cancers and in melanoma. We reconstructed survival tablesand calculated the number of events, which would result in a non-significant result for the primary endpoint. The FI was then compared to the number of patients in each trial who withdrew consent or were lost to follow-up. Regression analyses were used to explore associations between RCT characteristics and FI and trials in which FI was lower or equal to number of participants who withdrew consent or were lost to follow-up.

RESULTS: Among 81 RCTs, the median FI was 28. The median number of patients who withdrew consent or were lost to follow up was 27. FI was equal or lower than the number of patients who withdrew consent or were lost to follow-up in 47 trials (58%). There was a modest increase in FI over time (p = 0.02). Trials with overall survival as the primary endpoint (p = 0.006) and those in the palliative setting (p < 0.001) had lower FI. There was no association with trial sample size or duration of follow-up.

FINDINGS: Statistical significance of RCTs in common solid tumours can be reversed often with a small number of additional events. Post-approval RCTs or real-world data analyses should be performed to ensure results of registration trials are robust.

PMID:33652263 | DOI:10.1016/j.ctrv.2021.102167

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Nevin Manimala Statistics

Timing of gait events affects whole trajectory analyses: A statistical parametric mapping sensitivity analysis of lower limb biomechanics

J Biomech. 2021 Feb 17;119:110329. doi: 10.1016/j.jbiomech.2021.110329. Online ahead of print.

ABSTRACT

Time continuous analyses, such as statistical parametric mapping (SPM), have been increasingly used in biomechanics research to determine differences between populations, interventions and methodologies. Currently, it is not known how sensitive time-continuous analyses are to timing variability that occur in gait data. We evaluated this sensitivity by examining the frequency of significant SPM outcomes between two walking speeds when lower limb kinematics and kinetics were segmented and aligned based on 40 repeatable gait events. These events, defined in the supplementary material, include a commonly used event like foot contact and other events that have been previously demonstrated to be repeatable. Repeatable gait events were determined from joint and segment kinematics, joint kinetics as well as ground reaction forces. We examined the frequency of statistical outcomes for a single subject with different numbers of strides analyzed and for a cohort of 10 subjects. Our findings demonstrate that gait interventions, such as changes in walking speed, can induce temporal shifts that affect time-continuous outcomes for both cohort- and subject-level analyses. As both timing and magnitude are important in gait data, researchers are encouraged to perform additional analyses to understand how both of these variables affect time-continuous analysis outcomes. Finally, we demonstrate that multiple SPM tests can be performed to determine if statistical outcomes are due to temporal shifting or differences in magnitude. It is important to understand how both timing and magnitude of biomechanical data influences time continuous analyses as these analyses inform injury prevention, device development and basic understanding of biomechanics.

PMID:33652238 | DOI:10.1016/j.jbiomech.2021.110329

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Nevin Manimala Statistics

Maternal perception of the risk of vertically transmitted infections: the impact of expert counselling

Am J Obstet Gynecol MFM. 2021 Feb 27:100341. doi: 10.1016/j.ajogmf.2021.100341. Online ahead of print.

ABSTRACT

BACKGROUND: Insufficient and imprecise information during pregnancy can lead to an overestimation of maternal and fetal risk associated to various exposures during gestation.

OBJECTIVE: The aim of this study was to assess if expert obstetric counseling in cases of maternal infections at risk of vertical transmission could impact maternal perception of risk and the tendency to terminate pregnancy.

STUDY DESIGN: This is a monocentric prospective observational study of 185 consecutive pregnant women with confirmed diagnosis of infectious diseases at risk of vertical transmission during the first or second trimester of pregnancy. Patients were divided into two different groups, according to the type infectious disease: infections at high risk of fetal damages and infections at low risk. Every woman included in the study underwent medical counselling with a physician with experience of vertically transmitted infections. Moreover, each woman involved in the study was offered a detailed second trimester ultrasound scan. Maternal concern for their pregnancy and the disposition to interrupt the pregnancy were investigated by two questionnaires submitted to patients before and after medical expert counseling; a third questionnaire was completed only by those women who decided to undergo second trimester ultrasound scan at our Hospital.

RESULTS: Of the 185 consecutive patients meeting the inclusion criteria, 171 (92.4%) filled out the VAS for concern about the baby’s health both before and after medical consultation. Following medical consultation, there was a significant decrease in mean VAS for concern; from 67.1±26.0 to 41.3±28.8 (change score -25.8; 95% CI -29.9, -21.7). Higher baseline levels of concern had more room for reduction, and infections at high fetal risk of damage were associated with lower decrease in concern. However, risk perception decreased in both low-risk and high-risk pregnancies. Eighty-two patients (53.2%) underwent ultrasonography and filled out the VAS following examination. Mean score after examination was 28.3±24.4 and significantly lower than mean score registered after consultation (change score -16.6; 95% CI -22.9, -10.3). A total of 162 (87.6%) women declared their tendency to interrupt pregnancy both before and after the consultation. There was a significant decrease in mean tendency from 42.1±32.6 to 22.7±27.1 (change score -19.4; 95% CI -23.6, -15.2). Regression analysis revealed that both low- and high-risk patients significantly reduced their tendency. Seventy-three (45.1%) patients underwent ultrasonography and filled out the VAS following examination. Mean score after examination was 9.9±20.6 and significantly lower than mean score registered after consultation (change score -13.4; 95% CI -19.1, -7.7).

CONCLUSION: Our results confirm the importance of a comprehensive and sufficient expert medical counselling that, on one hand, can reduce maternal risk perception, improving quality of life for mothers, and on the other hand, can lead to feasible results, reducing a woman’s disposition to termination of pregnancy.

PMID:33652157 | DOI:10.1016/j.ajogmf.2021.100341

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Nevin Manimala Statistics

Detection of acacia honey adulteration with high fructose corn syrup through determination of targeted α‑Dicarbonyl compound using ion mobility-mass spectrometry coupled with UHPLC-MS/MS

Food Chem. 2021 Feb 20;352:129312. doi: 10.1016/j.foodchem.2021.129312. Online ahead of print.

ABSTRACT

High-value acacia honey is often adulterated with inexpensive high fructose corn syrup (HFCS), due to their similar color and sugar composition. α‑Dicarbonyl compounds formed by Maillard reaction or caramelization during heat treatment or storage, differ between HFCS and honey due to differences in starting materials and processing methods. In this study, we compared α-dicarbonyl compounds in acacia honey and HFCS by Ion Mobility-Mass Spectrometry and multivariate statistical analysis. Through α-dicarbonyl compound derivatization with o-phenylenediamine, we screened a marker with 189.1023 m/z and 139.3 Å2 Collision Cross-Section that can distinguish HFCS from acacia honey. Nuclear magnetic resonance spectra identified this marker compound as 3,4-dideoxypentosulose. We then used chromatography-coupled tandem mass spectrometry to quantitate 3,4-dideoxypentosulose in market samples of honey and HFCS and found that 3,4-dideoxypentosulose was negligible (<0.098 mg/kg) in honey, but prevalent in HFCS (≧1.174 mg/kg), indicating 3,4-dideoxypentosulose can serve as an alternative indicator of HFCS adulteration of acacia honey.

PMID:33652193 | DOI:10.1016/j.foodchem.2021.129312

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Nevin Manimala Statistics

Higher Efficacy of Infliximab than Immunoglobulin on Kawasaki Disease, a Meta-analysis

Eur J Pharmacol. 2021 Feb 27:173985. doi: 10.1016/j.ejphar.2021.173985. Online ahead of print.

ABSTRACT

This meta-analysis evaluated the efficacy and safety of infliximab as initial therapy for patients with Kawasaki disease (KD) and intravenous immunoglobulin (IVIG) resistant KD.Studies of infliximab in KD, published between January 2004 and December 2019, were curated from PubMed, MEDLINE, and Cochrane Library. Data were analyzed using STATA Version 12.0. Of the 8 studies considered, 4 evaluated the effect of infliximab combined with IVIG as primary therapy in KD, and the remaining investigated the effect of infliximab in IVIG resistant patients. Infliximab was more effective than the control group, with the total summary odds ratio (OR) of 0.34 (95% confidence interval (CI): 0.19-0.62). The treatment resistance of the infliximab group was lower than the IVIG group (0.36 [95% CI: 0.14-0.92]) when infliximab was combined with IVIG as the initial treatment. However, infliximab treatment for IVIG resistant KD was more effective than the IVIG group (0.28 [95% CI: 0.12-0.66]). There was no significant increase in the incidence of coronary artery lesions. The total summary OR for the incidence of coronary artery lesions and infliximab treatment was 0.88 (95% CI: 0.48-1.62). There was no statistically significant difference in adverse events (AEs) when compared between the groups (0.71 [95% CI: 0.44-1.16]).Infliximab combined with IVIG reduced treatment resistance in KD patients vs. conventional IVIG therapy. Infliximab improved clinical course in IVIG resistant KD patients. Infliximab treatment did not reduce the incidence of coronary artery lesions and did not show any significant increase in the incidence of AEs. PROSPERO REGISTRATION NUMBER: CRD42020218554.

PMID:33652059 | DOI:10.1016/j.ejphar.2021.173985

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Nevin Manimala Statistics

Missing at random assumption made more plausible: evidence from the 1958 British birth cohort

J Clin Epidemiol. 2021 Feb 27:S0895-4356(21)00062-7. doi: 10.1016/j.jclinepi.2021.02.019. Online ahead of print.

ABSTRACT

OBJECTIVE: Non-response is unavoidable in longitudinal surveys. The consequences are lower statistical power and the potential for bias. We implemented a systematic data-driven approach to identify predictors of non-response in the National Child Development Study (NCDS; 1958 British birth cohort). Such variables can help make the missing at random assumption more plausible, which has implications for the handling of missing data STUDY DESIGN AND SETTING: : We identified predictors of non-response using data from the 11 sweeps (birth to age 55) of the NCDS (n = 17,415), employing parametric regressions and the LASSO for variable selection.

RESULTS: Disadvantaged socio-economic background in childhood, worse mental health and lower cognitive ability in early life, and lack of civic and social participation in adulthood were consistently associated with non-response. Using this information, along with other data from NCDS, we were able to replicate the “population distribution” of educational attainment and marital status (derived from external data), and the original distributions of key early life characteristics.

CONCLUSION: The identified predictors of non-response have the potential to improve the plausibility of the missing at random assumption. They can be straightforwardly used as “auxiliary variables” in analyses with principled methods to reduce bias due to missing data.

PMID:33652080 | DOI:10.1016/j.jclinepi.2021.02.019

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Nevin Manimala Statistics

Place of Residence before and Place of Discharge after Femoral Neck Fracture Surgery Are Associated with Mortality: A Study of 1238 Patients with at Least Three Years’ Follow-up

Orthop Traumatol Surg Res. 2021 Feb 27:102876. doi: 10.1016/j.otsr.2021.102876. Online ahead of print.

ABSTRACT

BACKGROUND: Femoral neck fractures constitute a major public health challenge. The risk of death after surgery depends chiefly on the patient’s general health and comorbidities. No studies assessing place of residence are available. The objectives of this study were to determine whether mortality differed according to the patient’s previous place of residence and to the place of discharge, and to describe the complications occurring after femoral neck fracture surgery.

HYPOTHESIS: After femoral neck fracture surgery, the place of discharge is associated with the risk of death, and the complication rate is high.

METHODS: This single-centre retrospective study included 1241 adults who sustained a true femoral neck fracture between 2006 and 2016 and were followed-up for at least 3 years. The following data were collected: age at the time of the fracture, sex, hospital stay length, place of residence before and after the fracture, characteristics of the fracture, type of treatment, time from the fracture to surgery, and whether anticoagulant therapy was given. We then recorded data on mortality and complications.

RESULTS: The 3-year mortality rate was 36.0±1.4% (95%CI, 33.3-38.7). Place of residence before the fracture was strongly associated with mortality: the risk of death was higher in patients who lived in care homes (hazard ratio [HR], 2.18) or were hospitalised (HR, 1.78) and lower in patients who lived at home (HR, 0.46). The risk of death was also higher in patients discharged to care homes (HR, 1.82) or to hospitals (HR, 1.90) and lower in patients discharged home (HR, 0.30). All these differences were statistically significant (P<0.0001).

CONCLUSION: Place of residence and likely place of discharge should be evaluated as soon as the patient is admitted to the emergency department, in order to provide the best information possible to the patient and family and to establish the most appropriate treatment strategy. Patient self-sufficiency is a major parameter that should be preserved to the extent possible.

LEVEL OF EVIDENCE: IV.

PMID:33652150 | DOI:10.1016/j.otsr.2021.102876

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Nevin Manimala Statistics

Effects of Implementation of Infant-Driven Oral Feeding Guideline on Preterm Infants’ Abilities to Achieve Oral Feeding Milestones, in a Tertiary Neonatal Intensive Care Unit

Nutr Clin Pract. 2021 Mar 2. doi: 10.1002/ncp.10635. Online ahead of print.

ABSTRACT

OBJECTIVE: This study examines the hypothesis that infant-driven oral feeding leads to earlier achievement of oral feeding and reduces the length of hospital stay compared with provider-driven oral feeding in premature infants METHODS: We used a retrospective chart review to compare 2 groups of premature infants born at ≤35 weeks of gestation. The control group (CG) received the Provider-Driven Oral Feeding model and the intervention group (IG) received the Infant-Driven Oral Feeding model. Postmenstrual age (PMA) upon achieving full oral feeding, PMA at first oral feeding, discharge weight, and length of hospital stay were compared between the groups.

RESULTS: There are 208 infants in CG and 170 infants in IG. Infants in IG were born, on average, at a lower gestational age and birth weight than infants in CG. The median PMA at full oral feeding of 35 2/7 weeks (interquartile range [IQR], 34 2/7-36 2/7) for IG is significantly lower than the median of 35 5/7 weeks (IQR, 35-36 5/7) for CG, P-value < 0.001. Median PMA at first oral feeding is 34 1/7 weeks for both groups. Median PMA at discharge was 36 6/7 weeks for both groups. Median discharge weights of 2509 g (IQR, 2175-2964) for IG and 2459 g (IQR, 2204-2762) for CG are not statistically different.

CONCLUSION: Implementation of the Infant-Driven Feeding guideline led to earlier achievement of full oral feeding by 3 days on average while maintaining the same discharge weight but did not lead to earlier hospital discharge.

PMID:33651895 | DOI:10.1002/ncp.10635

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Nevin Manimala Statistics

Life Satisfaction, Perceived Discrimination, Religiosity, and Mental Health in Sufism: a Perspective from Montreal

Sante Ment Que. 2020 Fall;45(2):125-145.

ABSTRACT

Objective The central objective of this paper is to explore the dynamic interactions between 5 sets of variables, which are Sociodemographic Characteristics, Satisfaction with Life, Perceived Discrimination, Religiosity and Emotional Distress within Montreal’s Tariqa Qadiriya Boudchichiya, a Muslim Sufi way whose origins are Moroccan and date back to the 18th century. Method As a method, we considered psychological distress as the dependent variable and performed univariate descriptive statistical analyzes, bivariate correlation analyzes (Pearson correlation), one-way ANOVA analyzes, and multivariate analyzes (linear regressions). Results Our results, although preliminary due to a relatively small sample (n = 56), allow us to put forward a new hypothesis suggesting that the intense spiritual practice that characterizes the Tariqa, would allow “a work of the self on self” through a set of “techniques of the self” (Foucault) that contribute to a certain emotional well-being, if not to mental health. Conclusion Our conclusion underlines the importance of investigating more in depth the possible contribution of religiosity to the subject’s capacity to act on oneself in order to emerge as a spiritual, ethical and political subject.

PMID:33651936

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Nevin Manimala Statistics

National noncommunicable disease monitoring survey (NNMS) in India: Estimating risk factor prevalence in adult population

PLoS One. 2021 Mar 2;16(3):e0246712. doi: 10.1371/journal.pone.0246712. eCollection 2021.

ABSTRACT

BACKGROUND: The primary objective of National NCD monitoring survey (NNMS) was to generate national-level estimates of key NCD indicators identified in the national NCD monitoring framework. This paper describes survey study protocol and prevalence of risk factors among adults (18-69 years).

MATERIALS AND METHODS: NNMS was a national level cross-sectional survey conducted during 2017-18. The estimated sample size was 12,000 households from 600 primary sampling units. One adult (18-69 years) per household was selected using the World Health Organization-KISH grid. The study tools were adapted from WHO-STEPwise approach to NCD risk factor surveillance, IDSP-NCD risk factor survey and WHO-Global adult tobacco survey. Total of 8/10 indicators of adult NCD risk factors according to national NCD disease monitoring framework was studied. This survey for the first time estimated dietary intake of salt intake of population at a national level from spot urine samples.

RESULTS: Total of 11139 households and 10659 adults completed the survey. Prevalence of tobacco and alcohol use was 32.8% (95% CI: 30.8-35.0) and 15.9% (95% CI: 14.2-17.7) respectively. More than one-third adults were physically inactive [41.3% (95% CI: 39.4-43.3)], majority [98.4% (95% CI: 97.8-98.8)] consumed less than 5 servings of fruits and / or vegetables per day and mean salt intake was 8 g/day (95% CI: 7.8-8.2). Proportion with raised blood pressure and raised blood glucose were 28.5% (95% CI: 27.0-30.1) and 9.3% (95% CI: 8.3-10.5) respectively. 12.8% (95% CI: 11.2-14.5) of adults (40-69 years) had ten-year CVD risk of ≥30% or with existing CVD.

CONCLUSION: NNMS was the first comprehensive national survey providing relevant data to assess India’s progress towards targets in National NCD monitoring framework and NCD Action Plan. Established methodology and findings from survey would contribute to plan future state-based surveys and also frame policies for prevention and control of NCDs.

PMID:33651825 | DOI:10.1371/journal.pone.0246712