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Nevin Manimala Statistics

Factor structure of the Fear of Cancer Recurrence Inventory (FCRI): Comparison of international FCRI factor structure data and factor analysis of the Dutch FCRI-NL using three predominantly breast cancer samples

Eur J Cancer Care (Engl). 2021 Mar 25:e13431. doi: 10.1111/ecc.13431. Online ahead of print.

ABSTRACT

OBJECTIVE: Factor structure results of Fear of Cancer Recurrence Inventory (FCRI) translations are inconclusive. Through investigating the factor structure, this study aimed to improve the FCRI and its usability. Therefore, we did a comprehensive comparison of the factor structure results of all translations, by exploring and improving the structure of the Dutch FCRI-NL and by testing this new factor structure in two patient samples.

METHODS: To compare factor structure results of FCRI translations, we did a literature search using PubMed and Google Scholar. We performed exploratory factor analysis (EFA) in a mixed cancer sample. The confirmatory factor analyses (CFAs) were secondary analyses performed in two randomized controlled trial samples: consecutive breast cancer patients and distressed, mainly breast cancer patients.

RESULTS: All translations showed comparable and reasonable factor structure results; however, the FCRI factor structure can be improved. The EFA resulted in a four-factor solution: fear of cancer recurrence (FCR) severity, cognitive coping, impact of FCR on functioning and behavioural coping. However, the 4-factor CFAs did not fit the sample 2 and 3 data well.

CONCLUSION: Further exploring the FCRI-NL factor structure did not result in a psychometrically stronger FCRI-NL. Therefore, we recommend retaining the 7-factor FCRI-NL.

PMID:33763943 | DOI:10.1111/ecc.13431

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The alcohol advertising ban in Norway: Effects on recorded alcohol sales

Drug Alcohol Rev. 2021 Mar 24. doi: 10.1111/dar.13289. Online ahead of print.

ABSTRACT

INTRODUCTION: Although bans or restrictions on alcohol advertising are recommended as one of the three most effective and cost-effective policies to curb alcohol consumption, the best evidence to support this is indirect. The aim of this study was to examine whether the complete ban on alcohol advertising in Norway in 1975 had any effect on total alcohol sales.

METHODS: Annual time series of recorded alcohol sales (1960-2006) were analysed. Autoregressive integrated moving average interrupted time series techniques were used to model the effect of the advertising ban, adjusting for alcohol prices and wages.

RESULTS: The autoregressive integrated moving average analyses showed a negative and statistically significant effect of the ban on total recorded alcohol sales, suggesting an immediate and lasting reduction of 7.4% (P = 0.002).

DISCUSSION AND CONCLUSIONS: The complete ban on alcohol advertising in 1975 in Norway reduced recorded alcohol sales. This suggests that the ban had a protective effect by reducing total alcohol consumption. The conclusion remains tentative because of possible effects of unrecorded alcohol consumption and marketing on social media and satellite TV channels.

PMID:33763886 | DOI:10.1111/dar.13289

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Informative array testing with multiplex assays

Stat Med. 2021 Mar 24. doi: 10.1002/sim.8954. Online ahead of print.

ABSTRACT

High-volume testing of clinical specimens for sexually transmitted diseases is performed frequently by a process known as group testing. This algorithmic process involves testing portions of specimens from separate individuals together as one unit (or “group”) to detect diseases. Retesting is performed on groups that test positively in order to differentiate between positive and negative individual specimens. The overall goal is to use the least number of tests possible across all individuals without sacrificing diagnostic accuracy. One of the most efficient group testing algorithms is array testing. In its simplest form, specimens are arranged into a grid-like structure so that row and column groups can be formed. Positive-testing rows/columns indicate which specimens to retest. With the growing use of multiplex assays, the increasing number of diseases tested by these assays, and the availability of subject-specific risk information, opportunities exist to make this testing process even more efficient. We propose specific specimen arrangements within an array that can reduce the number of retests needed when compared with other array testing algorithms. We examine how to calculate operating characteristics, including the expected number of tests and the SD for the number of tests, and then subsequently find a best arrangement. Our methods are illustrated for chlamydia and gonorrhea detection with the Aptima Combo 2 Assay. We also provide R functions to make our research accessible to laboratories.

PMID:33763901 | DOI:10.1002/sim.8954

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A Prospective, Longitudinal Magnetic Resonance Imaging Evaluation of Cerebrovascular Reactivity and Infarct Development in Patients With Intracranial Stenosis

J Magn Reson Imaging. 2021 Mar 24. doi: 10.1002/jmri.27605. Online ahead of print.

ABSTRACT

BACKGROUND: Patients with symptomatic atherosclerotic and non-atherosclerotic (i.e., moyamoya) intracranial steno-occlusive disease experience high 2-year infarct rates.

PURPOSE: To investigate whether cerebral blood flow (CBF) and cerebrovascular reactivity (CVR) measures may provide biomarkers of 1-to-2-year infarct risk.

STUDY TYPE: Prospective, longitudinal study.

SUBJECTS: Adult participants (age = 18-85 years) with symptomatic intracranial atherosclerotic disease (N = 26) or non-atherosclerotic (i.e., moyamoya; N = 43) and stenosis ≥50% of a major intracranial artery were initially scanned within 45 days of stroke. Follow-up imaging (target = 1.5 years) was acquired for new infarct assessment.

FIELD STRENGTH/SEQUENCE: 3.0 Tesla with normocapnic arterial spin labeling (ASL) and blood oxygenation level-dependent (BOLD) imaging acquired during an interleaved hypercapnic (3 minutes) and normocapnic (3 minutes) respiratory stimulus.

ASSESSMENT: CBF, maximum CVR, and time-to-maximum CVR (i.e., CVRDELAY ) were calculated. Laterality indices (difference between infarcted and contralesional hemispheres divided by sum of absolute values) of metrics at enrollment were contrasted between participants with vs. without new infarcts on follow-up.

STATISTICAL TESTS: Laterality indices were compared using non-parametric Wilcoxon tests (significance: two-sided P < 0.05) and effect sizes as Cohen’s d. Continuous variables are presented as mean ± SD.

RESULTS: New infarcts were observed on follow-up in 15.0% of participants. The laterality index of the CVRDELAY was elevated (P = 0.01) in participants with atherosclerosis with new infarcts (index = 0.13) compared to participants without new infarcts (index = 0.05).

DATA CONCLUSION: Elevated CVRDELAY may indicate brain parenchyma at increased risk for new infarcts in patients with symptomatic intracranial atherosclerotic disease treated with standard-of-care medical management.

LEVEL OF EVIDENCE: 2 TECHNICAL EFFICACY STAGE: 3.

PMID:33763922 | DOI:10.1002/jmri.27605

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The presence of smear-layer affects the antimicrobial action of root canal sealers

Int Endod J. 2021 Mar 24. doi: 10.1111/iej.13522. Online ahead of print.

ABSTRACT

AIM: To assess the chemical and microstructural characteristics of dentine after the use of two irrigation protocols and correlate this with the antimicrobial properties of HCSC and changes to the dentine structure / chemistry after sealer placement.

METHODOLOGY: Two irrigation protocols – Protocol A using 2% NaOCl used 5mL/5 min and Protocol B with 2% NaOCl (5mL/5 min) followed by 17% EDTA (5mL/3 min) were used to prepare dentine. The chemical and microstructural changes following irrigation were assessed by scanning electron microscopy (SEM), energy dispersive spectroscopy (EDS) and Fourier transform infrared (FT-IR) spectroscopy (n=5) on dentine obtained from the mid-root and coronal parts of extracted human teeth. Four sealers (AH Plus, BioRoot, MTA Fillapex, TotalFill) were characterized by SEM/EDS (n=3). The ability of the sealers to eradicate intratubular Enterococcus faecalis biofilms was assessed by live/dead dye and confocal laser scanning microscopy to measure the percentage of living cells. The effect of combined irrigation and root filling on the dentine was assessed by SEM and EDS analysis (n=5). Statistical analysis was undertaken using one-way ANOVA and a number of post hoc tests to detect intergroup differences. The F test was used for comparison of variances in the microbiology testing.

RESULTS: The use of NaOCl alone left the smear layer seemingly intact, with traces of chlorine remaining on dentine. The use of BioRoot sealer restored the calcium ion levels of dentine which are depleted by the irrigation with EDTA. BioRoot exhibited antimicrobial properties against intratubular bacteria even in the presence of smear layer (Protocol A). The smear layer removal improved the bactericidal effect of all sealers and Ca2+ leaching. The use of a chelating agent was important for the intratubular sealer penetration for AH Plus but not the other sealers.

CONCLUSION: The removal of smear layer was associated with greater penetration of AH Plus into the dentinal tubules but not for the penetration of HCSC sealers. BioRoot was a more effective sealer in reducing the bacterial load in the dentinal tubules than the other materials tested and the presence of smear layer did not affect its activity.

PMID:33763882 | DOI:10.1111/iej.13522

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A binary hidden Markov model on spatial network for amyotrophic lateral sclerosis disease spreading pattern analysis

Stat Med. 2021 Mar 24. doi: 10.1002/sim.8956. Online ahead of print.

ABSTRACT

Amyotrophic lateral sclerosis (ALS) is a neurological disease that starts at a focal point and gradually spreads to other parts of the nervous system. One of the main clinical symptoms of ALS is muscle weakness. To study spreading patterns of muscle weakness, we analyze spatiotemporal binary muscle strength data, which indicates whether observed muscle strengths are impaired or healthy. We propose a hidden Markov model-based approach that assumes the observed disease status depends on two latent disease states. The model enables us to estimate the incidence rate of ALS disease and the probability of disease state transition. Specifically, the latter is modeled by a logistic autoregression in that the spatial network of susceptible muscles follows a Markov process. The proposed model is flexible to allow both historical muscle conditions and their spatial relationships to be included in the analysis. To estimate the model parameters, we provide an iterative algorithm to maximize sparse-penalized likelihood with bias correction, and use the Viterbi algorithm to label hidden disease states. We apply the proposed approach to analyze the ALS patients’ data from EMPOWER Study.

PMID:33763884 | DOI:10.1002/sim.8956

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International travel-related control measures to contain the COVID-19 pandemic: a rapid review

Cochrane Database Syst Rev. 2021 Mar 25;3:CD013717. doi: 10.1002/14651858.CD013717.pub2.

ABSTRACT

BACKGROUND: In late 2019, the first cases of coronavirus disease 2019 (COVID-19) were reported in Wuhan, China, followed by a worldwide spread. Numerous countries have implemented control measures related to international travel, including border closures, travel restrictions, screening at borders, and quarantine of travellers.

OBJECTIVES: To assess the effectiveness of international travel-related control measures during the COVID-19 pandemic on infectious disease transmission and screening-related outcomes.

SEARCH METHODS: We searched MEDLINE, Embase and COVID-19-specific databases, including the Cochrane COVID-19 Study Register and the WHO Global Database on COVID-19 Research to 13 November 2020.

SELECTION CRITERIA: We considered experimental, quasi-experimental, observational and modelling studies assessing the effects of travel-related control measures affecting human travel across international borders during the COVID-19 pandemic. In the original review, we also considered evidence on severe acute respiratory syndrome (SARS) and Middle East respiratory syndrome (MERS). In this version we decided to focus on COVID-19 evidence only. Primary outcome categories were (i) cases avoided, (ii) cases detected, and (iii) a shift in epidemic development. Secondary outcomes were other infectious disease transmission outcomes, healthcare utilisation, resource requirements and adverse effects if identified in studies assessing at least one primary outcome.

DATA COLLECTION AND ANALYSIS: Two review authors independently screened titles and abstracts and subsequently full texts. For studies included in the analysis, one review author extracted data and appraised the study. At least one additional review author checked for correctness of data. To assess the risk of bias and quality of included studies, we used the Quality Assessment of Diagnostic Accuracy Studies (QUADAS-2) tool for observational studies concerned with screening, and a bespoke tool for modelling studies. We synthesised findings narratively. One review author assessed the certainty of evidence with GRADE, and several review authors discussed these GRADE judgements.

MAIN RESULTS: Overall, we included 62 unique studies in the analysis; 49 were modelling studies and 13 were observational studies. Studies covered a variety of settings and levels of community transmission. Most studies compared travel-related control measures against a counterfactual scenario in which the measure was not implemented. However, some modelling studies described additional comparator scenarios, such as different levels of stringency of the measures (including relaxation of restrictions), or a combination of measures. Concerns with the quality of modelling studies related to potentially inappropriate assumptions about the structure and input parameters, and an inadequate assessment of model uncertainty. Concerns with risk of bias in observational studies related to the selection of travellers and the reference test, and unclear reporting of certain methodological aspects. Below we outline the results for each intervention category by illustrating the findings from selected outcomes. Travel restrictions reducing or stopping cross-border travel (31 modelling studies) The studies assessed cases avoided and shift in epidemic development. We found very low-certainty evidence for a reduction in COVID-19 cases in the community (13 studies) and cases exported or imported (9 studies). Most studies reported positive effects, with effect sizes varying widely; only a few studies showed no effect. There was very low-certainty evidence that cross-border travel controls can slow the spread of COVID-19. Most studies predicted positive effects, however, results from individual studies varied from a delay of less than one day to a delay of 85 days; very few studies predicted no effect of the measure. Screening at borders (13 modelling studies; 13 observational studies) Screening measures covered symptom/exposure-based screening or test-based screening (commonly specifying polymerase chain reaction (PCR) testing), or both, before departure or upon or within a few days of arrival. Studies assessed cases avoided, shift in epidemic development and cases detected. Studies generally predicted or observed some benefit from screening at borders, however these varied widely. For symptom/exposure-based screening, one modelling study reported that global implementation of screening measures would reduce the number of cases exported per day from another country by 82% (95% confidence interval (CI) 72% to 95%) (moderate-certainty evidence). Four modelling studies predicted delays in epidemic development, although there was wide variation in the results between the studies (very low-certainty evidence). Four modelling studies predicted that the proportion of cases detected would range from 1% to 53% (very low-certainty evidence). Nine observational studies observed the detected proportion to range from 0% to 100% (very low-certainty evidence), although all but one study observed this proportion to be less than 54%. For test-based screening, one modelling study provided very low-certainty evidence for the number of cases avoided. It reported that testing travellers reduced imported or exported cases as well as secondary cases. Five observational studies observed that the proportion of cases detected varied from 58% to 90% (very low-certainty evidence). Quarantine (12 modelling studies) The studies assessed cases avoided, shift in epidemic development and cases detected. All studies suggested some benefit of quarantine, however the magnitude of the effect ranged from small to large across the different outcomes (very low- to low-certainty evidence). Three modelling studies predicted that the reduction in the number of cases in the community ranged from 450 to over 64,000 fewer cases (very low-certainty evidence). The variation in effect was possibly related to the duration of quarantine and compliance. Quarantine and screening at borders (7 modelling studies; 4 observational studies) The studies assessed shift in epidemic development and cases detected. Most studies predicted positive effects for the combined measures with varying magnitudes (very low- to low-certainty evidence). Four observational studies observed that the proportion of cases detected for quarantine and screening at borders ranged from 68% to 92% (low-certainty evidence). The variation may depend on how the measures were combined, including the length of the quarantine period and days when the test was conducted in quarantine.

AUTHORS’ CONCLUSIONS: With much of the evidence derived from modelling studies, notably for travel restrictions reducing or stopping cross-border travel and quarantine of travellers, there is a lack of ‘real-world’ evidence. The certainty of the evidence for most travel-related control measures and outcomes is very low and the true effects are likely to be substantially different from those reported here. Broadly, travel restrictions may limit the spread of disease across national borders. Symptom/exposure-based screening measures at borders on their own are likely not effective; PCR testing at borders as a screening measure likely detects more cases than symptom/exposure-based screening at borders, although if performed only upon arrival this will likely also miss a meaningful proportion of cases. Quarantine, based on a sufficiently long quarantine period and high compliance is likely to largely avoid further transmission from travellers. Combining quarantine with PCR testing at borders will likely improve effectiveness. Many studies suggest that effects depend on factors, such as levels of community transmission, travel volumes and duration, other public health measures in place, and the exact specification and timing of the measure. Future research should be better reported, employ a range of designs beyond modelling and assess potential benefits and harms of the travel-related control measures from a societal perspective.

PMID:33763851 | DOI:10.1002/14651858.CD013717.pub2

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Measuring the impact of systemic sclerosis on oral health-related quality of life in a UK population

J Oral Pathol Med. 2021 Mar 24. doi: 10.1111/jop.13177. Online ahead of print.

ABSTRACT

BACKGROUND: The objective of the present study was to identify the impact of systemic sclerosis (SSc) upon oral health-related quality of life (OHRQoL) of affected individuals resident in the UK.

METHODS: A total of 100 patients and their partners or carers were invited to complete questionnaires regarding the impact of SSc on quality of life and psychological wellbeing using valid and reliable patient-reported outcome measures (OHIP-14, MHISS, OIDP, MDAS and HADS. A total of 50 patients with SSc and 18 partners or carers who acted as controls returned the completed questionnaires. Statistical analyses were performed for comparisons of different variables.

RESULTS: All the mean scores of OHIP-14 [SSc (16.5±12.4) Vs controls (6.06±7.6, P .001)], MHISS components were significantly higher in patients than those of control group [SSc (21.26±12) Vs controls (4.8±7.3, P<.0001)]. Majority of OIDP mean scores were significantly worse in patients compared with controls [SSc (10±8.7) Vs controls (1.72±3.4, P<.0001)]. The mean of total MDAS [SSc (11.7±5.3) Vs controls (9.5±4.4)] and HADS scores were higher in patients compared to controls [SSc depression (4.8±3.3) and anxiety (6±4.6) Vs controls (3.7±3.1) (4.7±3.9)].

CONCLUSIONS: Although the present study are limited by the low response rate and its cross-sectional design, present results highlighted that systemic sclerosis has a negative impact on OHRQoL of the affected individuals hence the evaluation of associated psychological impact including anxiety and depression symptoms is needed to better understand, monitor and evaluate the disease comorbidity in patients with SSc.

PMID:33763880 | DOI:10.1111/jop.13177

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Optimal Oocyte Number in Controlled Ovarian Stimulation with Gonadotropin-Releasing Hormone Agonist/Antagonist and Day 3 Fresh Embryo Transfer

Reprod Sci. 2021 Mar 24. doi: 10.1007/s43032-021-00550-1. Online ahead of print.

ABSTRACT

We aimed to investigate the optimal number of oocytes retrieved in normal responders with the gonadotropin-releasing hormone (GnRH) antagonist (GnRHant) protocol in comparison with the GnRH agonist (GnRHa) long protocol. This retrospective study is based on a single-center cohort including 657 fresh cycles with day 3 embryo transfer using the GnRHa long protocol and the GnRHant flexible protocol at the fertility clinic of a university hospital between 2005 and 2019. The rate ratios (RR) of clinical pregnancy were evaluated using log-binomial regression depending on the categories by the number of retrieved oocytes and pituitary suppression methods. After controlling for age, body mass index, and basal follicle-stimulating hormone, women with 10-11 oocytes retrieved demonstrated a significantly higher chance of clinical pregnancy compared to the reference group (4-5 oocytes) (RR 1.68, 95% CI 1.12-2.53). However, retrieval of more than 11 oocytes did not show a significant difference in pregnancy rates (PR) from the reference group. In women treated with GnRHant, a significantly higher clinical PR was also observed in women with 10-11 oocytes retrieved compared to the reference group (RR 1.90, 95% CI 1.05-3.42). In women treated with GnRHa long protocol, a higher probability of clinical pregnancy was observed (RR 1.30, 95% CI 0.98-1.73) in the group with 8-11 oocytes retrieved and it demonstrated borderline statistical significance (P = 0.07). In summary, the optimal number of oocytes for maximizing the rate of a clinical pregnancy is different according to the method of pituitary suppression. Too many oocytes do not seem to be beneficial for achieving better clinical outcomes.

PMID:33763817 | DOI:10.1007/s43032-021-00550-1

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Is lentulospiral the best option for root canal filling of endodontically treated primary teeth? A systematic review and meta-analysis

Eur Arch Paediatr Dent. 2021 Mar 24. doi: 10.1007/s40368-021-00615-4. Online ahead of print.

ABSTRACT

PURPOSE: To evaluate the quality of root canal filling of primary teeth using lentulospiral in comparison with other instruments.

METHODS: Electronic databases (PubMed/MEDLINE, Scopus, TRIP, LILACS, and CENTRAL Cochrane) were searched up to Jan 2021. Clinical trials that compared the quality of root canal filling of endodontically treated primary teeth using lentulospiral with other instruments were included. Two reviewers independently selected the studies, extracted data, and assessed the risk of bias. Two outcomes were considered: inadequate root canal filling (under or overfilling) and presence of voids. Conventional meta-analyses were performed using a fixed-effects model. Statistical analyses were performed using RevMan5.3 at a significance level of 5%.

RESULTS: Of the 68 potentially relevant studies, eight were selected for full-text analysis, and three were included in the systematic review. The use of syringes resulted in a lower risk of presence of voids in the root canal filling compared to the use of lentulospiral (RR: 0.62 95% CI 0.45; 0.85). However, there was no difference between lentulospiral and bi-directional spiral (RR:1.17 95% CI: 0.90; 1.51). There was no significant difference between lentulospiral and syringes (RR: 1.37 95% CI 1.00; 1.87) considering the length of the root canal filling. The use of bi-directional spiral had a higher risk of inadequate root canal filling compared to the use of lentulospiral (RR: 1.75 95% CI: 1.12; 2.74). Two studies were at “high”, and one study at “unclear” risk of bias in the key domains.

CONCLUSIONS: There is insufficient scientific evidence showing the superiority of using lentulospiral for the root canal filling in endodontically treated primary teeth. Due to the limited level of evidence, professionals may opt to choose the instrument based on their preferences.

PMID:33763823 | DOI:10.1007/s40368-021-00615-4