Publications by authors named "T Schuster"

618 Publications

SARS-CoV-2 N501Y Introductions and Transmissions in Switzerland from Beginning of October 2020 to February 2021-Implementation of Swiss-Wide Diagnostic Screening and Whole Genome Sequencing.

Microorganisms 2021 Mar 25;9(4). Epub 2021 Mar 25.

Center for Emerging Viral Diseases, University Hospital Geneva, 1205 Geneva, Switzerland.

The rapid spread of the SARS-CoV-2 lineages B.1.1.7 (N501Y.V1) throughout the UK, B.1.351 (N501Y.V2) in South Africa, and P.1 (B.1.1.28.1; N501Y.V3) in Brazil has led to the definition of variants of concern (VoCs) and recommendations for lineage specific surveillance. In Switzerland, during the last weeks of December 2020, we established a nationwide screening protocol across multiple laboratories, focusing first on epidemiological and microbiological definitions. In January 2021, we validated and implemented an N501Y-specific PCR to rapidly screen for VoCs, which are then confirmed using amplicon sequencing or whole genome sequencing (WGS). A total of 13,387 VoCs have been identified since the detection of the first Swiss case in October 2020, with 4194 being B.1.1.7, 172 B.1.351, and 7 P.1. The remaining 9014 cases of VoCs have been described without further lineage specification. Overall, all diagnostic centers reported a rapid increase of the percentage of detected VOCs, with a range of 6 to 46% between 25 to 31 of January 2021 increasing towards 41 to 82% between 22 to 28 of February. A total of 739 N501Y positive genomes were analysed and show a broad range of introduction events to Switzerland. In this paper, we describe the nationwide coordination and implementation process across laboratories, public health institutions, and researchers, the first results of our N501Y-specific variant screening, and the phylogenetic analysis of all available WGS data in Switzerland, that together identified the early introduction events and subsequent community spreading of the VoCs.
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http://dx.doi.org/10.3390/microorganisms9040677DOI Listing
March 2021

Serum Lowers Bioactivity and Uptake of Synthetic Amorphous Silica by Alveolar Macrophages in a Particle Specific Manner.

Nanomaterials (Basel) 2021 Mar 3;11(3). Epub 2021 Mar 3.

Evonik Operations GmbH, Rodenbacher Chaussee 4, 63457 Hanau-Wolfgang, Germany.

Various cell types are compromised by synthetic amorphous silica (SAS) if they are exposed to SAS under protein-free conditions in vitro. Addition of serum protein can mitigate most SAS effects, but it is not clear whether this is solely caused by protein corona formation and/or altered particle uptake. Because sensitive and reliable mass spectrometric measurements of SiO NP are cumbersome, quantitative uptake studies of SAS at the cellular level are largely missing. In this study, we combined the comparison of SAS effects on alveolar macrophages in the presence and absence of foetal calf serum with mass spectrometric measurement of Si in alkaline cell lysates. Effects on the release of lactate dehydrogenase, glucuronidase, TNFα and HO of precipitated (SIPERNAT 50, SIPERNAT 160) and fumed SAS (AEROSIL OX50, AEROSIL 380 F) were lowered close to control level by foetal calf serum (FCS) added to the medium. Using a quantitative high resolution ICP-MS measurement combined with electron microscopy, we found that FCS reduced the uptake of particle mass by 9.9% (SIPERNAT 50) up to 83.8% (AEROSIL OX50). Additionally, larger particle agglomerates were less frequent in cells in the presence of FCS. Plotting values for lactate dehydrogenase (LDH), glucuronidase (GLU) or tumour necrosis factor alpha (TNFα) against the mean cellular dose showed the reduction of bioactivity with a particle sedimentation bias. As a whole, the mitigating effects of FCS on precipitated and fumed SAS on alveolar macrophages are caused by a reduction of bioactivity and by a lowered internalization, and both effects occur in a particle specific manner. The method to quantify nanosized SiO in cells is a valuable tool for future in vitro studies.
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http://dx.doi.org/10.3390/nano11030628DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7999370PMC
March 2021

Acceptability of a Patient Portal (Opal) in HIV Clinical Care: A Feasibility Study.

J Pers Med 2021 Feb 16;11(2). Epub 2021 Feb 16.

Department of Family Medicine, McGill University, Montreal, QC H3S 1Z1, Canada.

Opal (opalmedapps.com), a patient portal in use at the Cedars Cancer Centre of the McGill University Health Centre (MUHC) (Montreal, Canada), gives cancer patients access to their medical records, collects information on patient-reported outcome measures (PROMs), and has demonstrated patient satisfaction with care. This feasibility study aims to evaluate Opal's potential acceptability in the context of HIV care. People living with HIV (PLWH) and their healthcare providers (HCPs) completed cross-sectional surveys from August 2019 to February 2020 at large HIV centers, including the Chronic Viral Illness Service of the MUHC, and other HIV clinical sites in Montreal and Paris, France. This study comprised 114 PLWH (mean age 48 years old, SD = 12.4), including 74% men, 24% women, and 2% transgender or other; and 31 HCPs (mean age 46.5 years old, SD = 11.4), including 32% men, 65% women, and 3% other. Ownership of smartphones and tablets was high (93% PLWH, 96% HCPs), and participants were willing to use Opal (74% PLWH, 68% HCPs). Participants were interested in most Opal functions and PROMs, particularly PROMs capturing quality of life (89% PLWH, 77% HCPs), experience of healthcare (86% PLWH, 97% HCPs), and HIV self-management (92% PLWH, 97% HCPs). This study suggests Opal has high acceptability and potential usefulness as perceived by PLWH and HCPs.
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http://dx.doi.org/10.3390/jpm11020134DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7920437PMC
February 2021

Renal and intraglomerular haemodynamics in chronic heart failure with preserved and reduced ejection fraction.

ESC Heart Fail 2021 Apr 9;8(2):1562-1570. Epub 2021 Feb 9.

Department of Nephrology and Hypertension, University Hospital Erlangen, Friedrich-Alexander-University, Ulmenweg 18, Erlangen-Nuremberg, 91054, Germany.

Aims: Congestive heart failure (CHF) and impaired renal function are two often co-existing medical conditions and associated with adverse cardiovascular outcome. The aim of the current study was to assess renal and intraglomerular haemodynamics by constant infusion input clearance technique in subjects with CHF.

Methods And Results: The group of subjects with CHF consisted of 27 individuals with HFpEF and 27 individuals with HFrEF and were compared with 31 healthy controls. Subjects underwent renal clearance examination to measure glomerular filtration rate (GFR) and renal blood and plasma flow (RBF and RPF) and to calculate intraglomerular haemodynamics such as resistances of the afferent (R ) and efferent arterioles (R ) as well as intraglomerular pressure (P ). Measured GFR was lower in CHF subjects (68.1 ± 10.1 mL/min/1.73 m ) compared with controls (83.6 ± 13.4 mL/min/1.73 m , P  < 0.001) as was P (P  < 0.001). Total renal vascular resistance (RVR) was higher in CHF subjects (87.3 ± 20.1 vs. 73.8 ± 17.1 dyn × s/cm , P  < 0.001) mediated by an increased resistance at the afferent site (3201 ± 1084 vs. 2181 ± 796 dyn × s/cm , P  < 0.001). Comparing HFpEF and HFrEF subjects, R was higher in HFrEF subjects. The severity of CHF assessed by NT-proBNP revealed an inverse association with renal perfusion (RPF r = -0.421, P = 0.002, RBF r = -0.414, P = 0.002) and a positive relation with RVR (r = 0.346, P = 0.012) at the post-glomerular site (R : r = 0.318, P = 0.022).

Conclusions: Renal function assessed by measured GFR is reduced and renal vascular resistance at the preglomerular, afferent site is increased in HFpEF and, to greater extent, in HFrEF. Our data indicate a close cardiorenal interaction in CHF.
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http://dx.doi.org/10.1002/ehf2.13257DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8006684PMC
April 2021

A methodological review protocol of the use of Bayesian factor analysis in primary care research.

Syst Rev 2021 Jan 8;10(1):15. Epub 2021 Jan 8.

Department of Family Medicine, McGill University, 5858 Chemin de la Côte-des-Neiges, Suite 300, Montreal, QC, H3S 1Z1, Canada.

Background: The development of questionnaires for primary care practice and research is of increasing interest in the literature. In settings where valuable prior knowledge or preliminary data is available, Bayesian factor analysis can be used to incorporate such information when conducting questionnaire construct validation. This protocol outlines a methodological review that will summarize evidence on the current use of Bayesian factor analysis in the primary care literature.

Methods: A comprehensive search strategy has been developed and will be used to identify relevant literature (research studies in primary care) indexed in MEDLINE, Scopus, EMBASE, CINAHL, and Cochrane Library. The search strategy includes terms and synonyms for Bayesian factor analysis and primary care. The reference lists of relevant articles being identified will be screened to find further relevant studies. At least two reviewers will independently extract data and resolve discrepancies through consensus. Descriptive analyses will summarize the use and reporting of Bayesian factor analysis approaches for validating questionnaires applicable to primary care.

Discussion: This methodological review will provide a comprehensive overview of the current use and reporting of Bayesian factor analysis in primary care and will provide recommendations for its proper future use.

Systematic Review Registration: PROSPERO CRD42018114978.
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http://dx.doi.org/10.1186/s13643-020-01565-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7796554PMC
January 2021

Effects of leptin on the viability of MCF-7 and T47D cells at different glucose concentrations.

J Exp Clin Med (Samsun) 2020 9;37(4):119-125. Epub 2020 Nov 9.

Hormel Institute Medical Research Center, University of Minnesota, Austin, MN, USA.

Obesity is associated with increased risk of breast cancer. Leptin is a well-known factor involved in obesity and its serum levels are increased in breast cancer. Hyperglycemia is another significant risk factor for breast cancer. Consistently, high glucose induces proliferation and invasion of breast cancer cells and in-vivo calorie restriction reduce tumorigenesis in rodent models. The aim of this study was to investigate the effect of leptin on the viability and mode of cell death in breast cancer cells incubated in different glucose concentrations to represent caloric restriction. For this purpose, MCF-7 and T47D breast cancer cells incubated in different glucose concentrations for a total of 72 hours were treated with or without leptin either for one hour or 24 hours and the ratio of apoptotic, necrotic and alive cells were analyzed by flow cytometry. Our data revealed that glucose incubation significantly decreased apoptosis and necrosis, while increasing viability in both cell lines in a dose dependent manner. One-hour leptin treatment significantly decreased viability, and increased apoptosis but did not significantly affect necrosis in T47D cells incubated in 2.5 mM glucose. In MCF-7 cells, one-hour leptin incubation significantly increased necrosis but its effects on apoptosis and viability were not significant. In conclusion, although glucose induces cell death by apoptosis and necrosis in T47D and MCF-7 cells respectively in a dose dependent manner, the overallviability is still increased in both cell lines. One-hour leptin treatment reverses the effect of low glucose incubation on apoptosis of T47D and necrosis of MCF-7 cells. Moreover, the effect of one-hour leptin treatment on apoptosis or necrosis is significantly higher than that of 24-hour leptin treatment.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7783410PMC
November 2020

Does spaced education improve clinical knowledge among Family Medicine residents? A cluster randomized controlled trial.

Adv Health Sci Educ Theory Pract 2021 Jan 3. Epub 2021 Jan 3.

Université Laval, Quebec City, Canada.

Spaced education is a learning strategy to improve knowledge acquisition and retention. To date, no robust evidence exists to support the utility of spaced education in the Family Medicine residency. We aimed to test whether alerts to encourage spaced education can improve clinical knowledge as measured by scores on the Canadian Family Medicine certification examination.

Method: We conducted a cluster randomized controlled trial to empirically and pragmatically test spaced education using two versions of the Family Medicine Study Guide mobile app. 12 residency training programs in Canada agreed to participate. At six intervention sites, we consented 335 of the 654 (51%) eligible residents. Residents in the intervention group were sent alerts through the app to encourage the answering of questions linked to clinical cases. At six control sites, 299 of 586 (51%) residents consented. Residents in the control group received the same app but with no alerts. Incidence rates of case completion between trial arms were compared using repeated measures analysis. We linked residents in both trial arms to their knowledge scores on the certification examination of the College of Family Physicians of Canada.

Results: Over 67 weeks, there was no statistically significant difference in the completion of clinical cases by participants. The difference in mean exam scores and the associated confidence interval did not exceed the pre-defined limit of 4 percentage points.

Conclusion: Further research is recommended before deploying spaced educational interventions in the Family Medicine residency to improve knowledge.
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http://dx.doi.org/10.1007/s10459-020-10020-zDOI Listing
January 2021

Reported evidence on the effectiveness of mass media interventions in increasing knowledge and use of family planning in low and middle-income countries: a systematic mixed methods review.

J Glob Health 2019 Dec;9(2):020420

Department of Family Medicine, McGill University, Montréal, Quebec, Canada.

Background: An estimated 200 million women and girls in low and middle-income countries (LMICs) wish to delay, space or avoid becoming pregnant, yet are not using contraceptives. This study seeks to investigate the effectiveness of mass media interventions for increasing knowledge and use of contraceptives, and to identify barriers to program implementation.

Methods: Using a mixed-methods systematic approach, we searched five electronic databases using pre-determined search strategies and hand-searching of articles of any study design published from 1994 to 2017 of mass media interventions for family planning education. Two reviewers independently applied clearly defined eligibility criteria to the search results, quality appraisal, data extraction from published reports, and data analysis (using meta-analysis and thematic analysis) following PRISMA guidelines.

Results: We identified 59 eligible studies. Although the majority of studies suggest a positive association between media interventions and family planning outcomes, the pooled results are still consistent with possibly null intervention effects. The reported prevalence ratios (PR) for media interventions association with increased contraceptive knowledge range from 0.97 to 1.41, while the PRs for contraceptive use range from 0.54 to 3.23. The qualitative analysis indicates that there are barriers to contraceptive uptake at the level of individual knowledge (including demographic factors and preconceived notions), access (including issues relating to mobility and financing), and programming (including lack of participatory approaches).

Conclusions: There is a need for rigorous impact evaluation, including randomised controlled trials, of mass media interventions on knowledge and uptake of family planning in LMIC settings. Interventions should be better tailored to cultural and socio-demographic characteristics of the target populations, while access to resources should continue to remain a priority and be improved, where possible.
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http://dx.doi.org/10.7189/jogh.09.020420DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7686646PMC
December 2019

Development and Validation of the McGill Empowerment Assessment-Diabetes (MEA-D).

Diabetes Spectr 2020 Nov;33(4):307-314

Department of Family Medicine, McGill University, Montreal, Quebec, Canada.

Background: Diabetes is a prevalent chronic condition that poses a major burden for patients and the health care system. Evidence suggests that patient engagement in self-care improves diabetes control and reduces the risk of complications. To provide effective interventions that aim to improve empowerment processes relating to diabetes, a comprehensive and valid measure of empowerment is needed. This article details the development and validation of the McGill Empowerment Assessment-Diabetes (MEA-D).

Methods: The development and validation of the MEA-D questionnaire comprised three steps: item generation, qualitative face validation, and factorial content validation. An initial version was created by combining existing items and inductively generated items. Items were mapped to an empowerment framework with four domains: attitude, knowledge, behavior, and relatedness. Semi-structured interviews were conducted with 21 adults living with diabetes to assess face validity. The questionnaire was revised by a team of clinicians, researchers, and patient-partners. Factorial content validation was then performed using responses from 300 adult Canadians living with type 1 or type 2 diabetes.

Results: The final version of the MEA-D contained 28 items. A moderately good item-domain correlation was found between the individual items within the four domains. Cronbach's α was 0.81 (95% CI 0.78-0.85) for attitude, 0.73 (95% CI 0.67-0.79) for knowledge, 0.84 (95% CI 0.81-0.87) for behavior, and 0.81 (95% CI 0.77-0.84) for relatedness.

Conclusion: The evaluation of diabetes programs demands a validated measure of empowerment. We developed the MEA-D to address this need. The MEA-D may be adapted to measure patients' empowerment regarding other chronic health conditions.
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http://dx.doi.org/10.2337/ds19-0075DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7666606PMC
November 2020

Outcomes of Equity-Oriented, Web-Based Parenting Information in Mothers of Low Socioeconomic Status Compared to Other Mothers: Participatory Mixed Methods Study.

J Med Internet Res 2020 11 10;22(11):e22440. Epub 2020 Nov 10.

Department of Family Medicine, Université de Sherbrooke, Sherbrooke, QC, Canada.

Background: Typically, web-based consumer health information is considered more beneficial for people with high levels of education and income. No evidence shows that equity-oriented information offers equal benefits to all. This is important for parents of low socioeconomic status (SES; low levels of education and income and usually a low level of literacy).

Objective: This study is based on a conceptual framework of information outcomes. In light of this, it aims to compare the perception of the outcomes of web-based parenting information in low-SES mothers with that of other mothers and explore the perspective of low-SES mothers on contextual factors and information needs and behavior associated with these outcomes.

Methods: A participatory mixed methods research was conducted in partnership with academic researchers and Naître et grandir (N&G) editors. N&G is a magazine, website, and newsletter that offers trustworthy parenting information on child development, education, health, and well-being in a format that is easy to read, listen, or watch. Quantitative component (QUAN) included a 3-year longitudinal observational web survey; participants were mothers of 0- to 8-year-old children. For each N&G newsletter, the participants' perception regarding the outcomes of specific N&G webpages was gathered using a content-validated Information Assessment Method (IAM) questionnaire. Differences between participants of low SES versus others were estimated. Qualitative component (QUAL) was interpretive; participants were low-SES mothers. The thematic analysis of interview transcripts identified participants' characteristics and different sources of information depending on information needs. Findings from the two components were integrated (QUAN+QUAL integration) through the conceptual framework and assimilated into the description of an ideal-typical mother of low SES (Kate). A narrative describes Kate's perception of the outcomes of web-based parenting information and her perspective on contextual factors, information needs, and behavior associated with these outcomes.

Results: QUAN-a total of 1889 participants completed 2447 IAM responses (50 from mothers of low SES and 2397 from other mothers). N&G information was more likely to help low-SES participants to better understand something, decrease worries, and increase self-confidence in decision making. QUAL-the 40 participants (21 N&G users and 19 nonusers) used 4 information sources in an iterative manner: websites, forums, relatives, and professionals. The integration of QUAN and QUAL findings provides a short narrative, Kate, which summarizes the main findings.

Conclusions: This is the first study comparing perceptions of information outcomes in low-SES mothers with those of other mothers. Findings suggest that equity-oriented, web-based parenting information can offer equal benefits to all, including low-SES mothers. The short narrative, Kate, can be quickly read by decision policy makers, for example, web editors, and might encourage them to reach the underserved and provide and assess trustworthy web-based consumer health information in a format that is easy to read, listen, or watch.
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http://dx.doi.org/10.2196/22440DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7685922PMC
November 2020

Spline-based accelerated failure time model.

Stat Med 2021 Jan 26;40(2):481-497. Epub 2020 Oct 26.

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.

The accelerated failure time (AFT) model has been suggested as an alternative to the Cox proportional hazards model. However, a parametric AFT model requires the specification of an appropriate distribution for the event time, which is often difficult to identify in real-life studies and may limit applications. A semiparametric AFT model was developed by Komárek et al based on smoothed error distribution that does not require such specification. In this article, we develop a spline-based AFT model that also does not require specification of the parametric family of event time distribution. The baseline hazard function is modeled by regression B-splines, allowing for the estimation of a variety of smooth and flexible shapes. In comprehensive simulations, we validate the performance of our approach and compare with the results from parametric AFT models and the approach of Komárek. Both the proposed spline-based AFT model and the approach of Komárek provided unbiased estimates of covariate effects and survival curves for a variety of scenarios in which the event time followed different distributions, including both simple and complex cases. Spline-based estimates of the baseline hazard showed also a satisfactory numerical stability. As expected, the baseline hazard and survival probabilities estimated by the misspecified parametric AFT models deviated from the truth. We illustrated the application of the proposed model in a study of colon cancer.
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http://dx.doi.org/10.1002/sim.8786DOI Listing
January 2021

Exploiting Rules to Enhance Machine Learning in Extracting Information From Multi-Institutional Prostate Pathology Reports.

JCO Clin Cancer Inform 2020 10;4:865-874

Department of Oncology, Massachusetts General Hospital, Boston, MA.

Purpose: Literature on clinical note mining has highlighted the superiority of machine learning (ML) over hand-crafted rules. Nevertheless, most studies assume the availability of large training sets, which is rarely the case. For this reason, in the clinical setting, rules are still common. We suggest 2 methods to leverage the knowledge encoded in pre-existing rules to inform ML decisions and obtain high performance, even with scarce annotations.

Methods: We collected 501 prostate pathology reports from 6 American hospitals. Reports were split into 2,711 core segments, annotated with 20 attributes describing the histology, grade, extension, and location of tumors. The data set was split by institutions to generate a cross-institutional evaluation setting. We assessed 4 systems, namely a rule-based approach, an ML model, and 2 hybrid systems integrating the previous methods: a Rule as Feature model and a Classifier Confidence model. Several ML algorithms were tested, including logistic regression (LR), support vector machine (SVM), and eXtreme gradient boosting (XGB).

Results: When training on data from a single institution, LR lags behind the rules by 3.5% (F1 score: 92.2% 95.7%). Hybrid models, instead, obtain competitive results, with Classifier Confidence outperforming the rules by +0.5% (96.2%). When a larger amount of data from multiple institutions is used, LR improves by +1.5% over the rules (97.2%), whereas hybrid systems obtain +2.2% for Rule as Feature (97.7%) and +2.6% for Classifier Confidence (98.3%). Replacing LR with SVM or XGB yielded similar performance gains.

Conclusion: We developed methods to use pre-existing handcrafted rules to inform ML algorithms. These hybrid systems obtain better performance than either rules or ML models alone, even when training data are limited.
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http://dx.doi.org/10.1200/CCI.20.00028DOI Listing
October 2020

KLK3 and TMPRSS2 for molecular lymph-node staging in prostate cancer patients undergoing radical prostatectomy.

Prostate Cancer Prostatic Dis 2020 Sep 25. Epub 2020 Sep 25.

Department of Urology, Rechts der Isar Medical Center, Technical University of Munich, Munich, Germany.

Background: Lymph-node (LN) metastasis in prostate cancer (PC) is a main risk factor for tumor recurrence after radical prostatectomy (RP). Molecular analysis facilitates detection of small-volume LN metastases with higher sensitivity than histopathology. We aimed to prospectively evaluate six candidate gene markers for detection of pelvic LN metastases and to determine their ability to predict biochemical recurrence-free survival (bRFS) in patients treated with RP.

Methods: The expression of kallikrein 2, 3, and 4 (KLK2, KLK3, and KLK4), prostate-specific membrane antigen (PSMA), transmembrane serine protease 2 (TMPRSS2) and transient receptor potential cation channel subfamily M member 8 (TRPM8) was assessed using qPCR. We analyzed LNs from 111 patients (intermediate PC, n = 32 (29%); high-risk PC, n = 79 (71%)) who underwent RP and extended pelvic lymph-node dissection without neoadjuvant treatment.

Results: Overall, 2411 LNs were examined by molecular and histopathologic examination. Histopathology detected 69 LN metastases in 28 (25%) patients. KLK2 and KLK3 diagnostically performed best and classified all pN1-patients correctly as molecular node-positive (molN1/pN1). The concordance on LN level was best for KLK3 (96%). KLK2, KLK3, KLK4, PSMA, TMPRSS2, and TRPM8 reclassified 27 (24%), 32 (29%), 29 (26%), 8 (7%), 13 (12%), and 23 (21%) pN0-patients, respectively, as node-positive (pN0/molN1). On multivariable cox regression analysis molecular LN status (molN1 vs. molN0) using KLK3 (HR 4.0, p = 0.04) and TMPRSS2 (HR 5.1, p = 0.02) were independent predictors of bRFS. Median bRFS was shorter in patients with only molecular positive LNs (molN1/pN0) for KLK3 (24 months, p = 0.001) and for TMPRSS2 (12 months, p < 0.001) compared to patients with negative nodes (molN0/pN0) (median bRFS not reached).

Conclusions: For diagnostic purposes, KLK3 showed highest concordance with histopathology for detection of LN metastases in PC patients undergoing RP. For prognostic purposes, KLK3 and TMPRSS2 expression were superior to histopathologic LN status and other transcripts tested for molecular LN status. We suggest a combined KLK3/TMPRSS2 panel as a valuable diagnostic and prognostic tool for molecular LN analysis.
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http://dx.doi.org/10.1038/s41391-020-00283-3DOI Listing
September 2020

Protocol for a cluster-randomised non-inferiority trial of one versus two doses of ivermectin for the control of scabies using a mass drug administration strategy (the RISE study).

BMJ Open 2020 08 30;10(8):e037305. Epub 2020 Aug 30.

Tropical Disease Research Group, Murdoch Childrens Research Institute, Parkville, Victoria, Australia

Introduction: Scabies is a significant contributor to global morbidity, affecting approximately 200 million people at any time. Scabies is endemic in many resource-limited tropical settings. Bacterial skin infection (impetigo) frequently complicates scabies infestation in these settings. Community-wide ivermectin-based mass drug administration (MDA) is an effective control strategy for scabies in island settings, with a single round of MDA reducing population prevalence by around 90%. However, current two-dose regimens present a number of barriers to programmatic MDA implementation. We designed the Regimens of Ivermectin for Scabies Elimination (RISE) trial to investigate whether one-dose MDA may be as effective as two-dose MDA in controlling scabies in high-prevalence settings.

Methods And Analysis: RISE is a cluster-randomised non-inferiority trial. The study will be conducted in 20 isolated villages in Western Province of Solomon Islands where population prevalence of scabies is approximately 20%. Villages will be randomly allocated to receive either one dose or two doses of ivermectin-based MDA in a 1:1 ratio. The primary objective of the study is to determine if ivermectin-based MDA with one dose is as effective as MDA with two doses in reducing the prevalence of scabies after 12 months. Secondary objectives include the effect of ivermectin-based MDA on impetigo prevalence after 12 and 24 months, the prevalence of scabies at 24 months after the intervention, the impact on presentation to health facilities with scabies and impetigo, and the safety of one-dose and two-dose MDA.

Ethics And Dissemination: This trial has been approved by the ethics review committees of the Solomon Islands and the Royal Children's Hospital, Australia. Results will be disseminated in peer-reviewed publications and in meetings with the Solomon Islands Ministry of Health and Medical Services and participating communities.

Trial Registration Details: Australian New Zealand Clinical Trials Registry: ACTRN12618001086257. Date registered: 28 June 2018.
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http://dx.doi.org/10.1136/bmjopen-2020-037305DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7462236PMC
August 2020

Health outcomes in offspring born to survivors of childhood cancers following assisted reproductive technologies.

J Cancer Surviv 2021 Apr 26;15(2):259-272. Epub 2020 Aug 26.

Department of Pediatric Oncology and Hematology, Charité-Universitätsmedizin Berlin, Freie Universität Berlin, Humboldt-Universität zu Berlin, and Berlin Institute of Health, Augustenburger Platz 1, 13353, Berlin, Germany.

Purpose: An increasing number of childhood cancer survivors are using assisted reproductive technologies (ART) to overcome treatment-related fertility impairment. We report perinatal and health outcomes of offspring born to survivors following ART.

Methods: The FeCt Multicenter Offspring Study surveyed the health of offspring of childhood cancer survivors. Health outcomes in offspring born to survivors following ART (n = 57, 4.6%) or after spontaneous conception (n = 1182) were assessed in the German cohort (n = 1239) using bivariate analysis. Findings were put into the context of the general German population by health outcome assessment in 1:1 matched-pair analysis (n = 2478).

Results: Nearly twice the survivors used ART compared with numbers reported for the German general population (4.6% vs. 2.6%). Successful pregnancies were achieved after a median of two cycles, mainly using non-cryopreserved oocytes/sperm. Multiple sibling births (p < 0.001, 28.1% vs. 3.0%) and low birth weight (p = 0.008; OR = 2.659, 95% CI = 1.258-5.621) occurred significantly more often in offspring born to survivors who utilized ART than spontaneously conceived children, whereas similar percentages were born preterm or too small for their gestational age. ART did not increase the prevalence of childhood cancer or congenital malformations in offspring born to survivors.

Conclusion: ART use by childhood cancer survivors was successful with both fresh and cryopreserved oocytes/sperm, and did not influence perinatal health or health outcomes when known confounders were taken into account.

Implications For Cancer Survivors: Oncofertility is an important component of patient care. Our study implicates that the utilization of ART by adult survivors of childhood cancer does not put offspring at additional risk for adverse perinatal or health outcomes.
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http://dx.doi.org/10.1007/s11764-020-00929-0DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7966626PMC
April 2021

The impact of synthetic amorphous silica (E 551) on differentiated Caco-2 cells, a model for the human intestinal epithelium.

Toxicol In Vitro 2020 Sep 28;67:104903. Epub 2020 May 28.

Laboratory for Particles-Biology Interactions, Empa, Swiss Federal Laboratories for Materials Science and Technology, Lerchenfeldstrasse 5, CH-9014 St. Gallen, Switzerland. Electronic address:

For several decades, food-grade synthetic amorphous silica (SAS) have been used as a technological additive to reduce caking of food powders. Human exposure is thus inevitable and safety concerns are taken seriously. The toxicity of silica in general and SAS in particular has been studied extensively. Overall, there is little evidence that food-grade SAS pose any health risks to humans. However, from the available data it was often not clear which type of silica was used. Accordingly, the latest report of the European food safety authority requested additional toxicity data for well-characterised "real food-grade SAS". To close this gap, we screened a panel of ten well-defined, food-grade SAS for potential adverse effects on differentiated Caco-2 cells. Precipitated and fumed SAS with low, intermediate and high specific surface area were included to determine structure-activity relationships. In a physiological dose-range up to 50 μg/ml and 48 h of incubation, none of the materials induced adverse effects on differentiated Caco-2 cells. This held true for endpoints of acute cytotoxicity as well as epithelial specific measures of barrier integrity. These results showed that despite considerable differences in production routes and material characteristics, food-relevant SAS did not elicit acute toxicity responses in intestinal epithelial cells.
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http://dx.doi.org/10.1016/j.tiv.2020.104903DOI Listing
September 2020

Evaluating Prevalence and Patterns of Prescribing Medications for Depression for Patients With Obesity Using Large Primary Care Data (Canadian Primary Care Sentinel Surveillance Network).

Front Nutr 2020 17;7:24. Epub 2020 Mar 17.

Department of Family Medicine, Faculty of Medicine, McGill University, Montréal, QC, Canada.

Depression is a serious disorder that brings a tremendous health and economic burden. Many antidepressants (AD) have obesogenic effects, increasing the population of obese patients at increased risk for a more severe disease course and poor treatment response. In addition, obese patients with depression may not be receiving the recommended standard of care due to "obesity bias." It is important to evaluate prescribing pharmacological treatment of depression in patients with obesity. To describe the prevalence and patterns of AD prescribing for patients with depression and comorbid obesity compared with normal weight patients, and to examine the association of prescribing prevalence with obesity class. Study sample of adult patients (>18 years old) with depression was extracted from the national Canadian Primary Care Sentinel Surveillance Network (CPCSSN) Electronic Medical Records database for 2011-2016. Measures were prescribing of at least one AD (outcome) and body mass index (BMI) to categorize patients into weight categories (exposure). Data were analyzed cross-sectionally using descriptive statistics and mixed effects logistic regression model with clustering on CPCSSN networks and adjusting for age, sex, and the comorbidities. Of 120,381 patients with depression, 63,830 patients had complete data on studied variables (complete cases analysis). Compared with normal weight patients, obese patients were more likely to receive an AD prescription (adjusted Odds Ratio [aOR] = 1.17; 95% Confidence Interval [CI]: 1.12-1.22). Patients with obesity classes II and III were 8% (95% CI: 1.00, 1.16) and 6% (95% CI: 0.98, 1.16) more likely, respectively, to receive AD. After imputing missing data using Multiple Imputations by Chained Equations, the results remained unchanged. The prevalence of prescribing >3 AD types was higher in obese category (7.27%, [95% CI: 6.84, 7.73]) than in normal weight category (5.6%; [95% CI: 5.24, 5.99]). The association between obesity and high prevalence of AD prescribing and prescribing high number of different AD to obese patients, consistent across geographical regions, raises a public health concern. Study results warrant qualitative studies to explore reasons behind the difference in prescribing, and quantitative longitudinal studies evaluating the association of AD prescribing patterns for obese patients with health outcomes.
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http://dx.doi.org/10.3389/fnut.2020.00024DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7090027PMC
March 2020

Patient-initiated consultations in community pharmacies.

Res Social Adm Pharm 2021 Feb 13;17(2):428-440. Epub 2020 Mar 13.

Research Chair in Digital Health, HEC, Montréal, Canada.

Background: Mobilizing pharmacists practicing in community pharmacies as a new player in primary care has recently emerged as a cost-effective strategy for clinical consultations related to minor ailments. However, little is known about these consultations initiated by patients. The objectives of this study were to describe patient initiated consultations in community pharmacies, and to estimate the impact of these consultations on care-seeking behaviors of patients.

Methods: A cross sectional study was conducted in 11 retail pharmacies in Quebec, Canada, from October until December 2017, using two data sources: 1) an application and 2) structured interviews. Pharmacists had to compile all consultations in the app during a 4 week-period. Consenting patients were interviewed on the day of the consultation and one week after. Descriptive statistics on the number of consultations were calculated, as well as on the recommendation and the experience of the patient.

Results: A total number of 4994 consultations were entered in the app by 55 pharmacists, with an average of 18 consultations (SD = 7) per pharmacy per day. Of the 900 patients consented to participate to the study, 600 (67%) completed the two interviews. Pharmacists reported that they recommended another healthcare resource to patients (e.g. emergency department (ED), walk-in clinic) in only 15% of cases. In the week following the consultation, 105 (18%) patients reported that they avoided going to the ED as a result of the consultation. Patients in rural regions or consulting in a pharmacy far from a medical clinic were more likely to report avoiding an ED visit as a result of the consultation with the pharmacist.

Conclusions: This study suggests that patients are seeking advice from pharmacists for a variety of health care concerns and that pharmacists are able to manage most of these consultations, with a high level of patient satisfaction.
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http://dx.doi.org/10.1016/j.sapharm.2020.03.001DOI Listing
February 2021

Impfungen und Vorsorgeuntersuchungen – Präventionsverhalten bei Nachkommen ehemaliger kinderonkologischer Patienten in Deutschland.

Klin Padiatr 2020 May 16;232(3):143-150. Epub 2020 Mar 16.

Paediatric Oncology, Haematology and Stem Cell Transplantation, Charite Universitätsmedizin Berlin, Berlin.

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http://dx.doi.org/10.1055/a-1114-6350DOI Listing
May 2020

Predictors of patient satisfaction and outpatient health services in China: evidence from the WHO SAGE survey.

Fam Pract 2020 Sep;37(4):465-472

Department of Family Medicine, McGill University, Montréal, Canada.

Background: Patient satisfaction is an essential indicator in medical practise and research. To monitor the health and well-being of adult populations and the ageing process, the World Health Organization (WHO) has initiated the Study on Global AGEing and Adult Health (SAGE), compiling longitudinal information in six countries including China as one major data source.

Objective: The objective of this study was to identify potential predictors for patient satisfaction based on the 2007-10 WHO SAGE China survey.

Methods: Data were analysed using random forests (RFs) and ordinal logistic regression models based on 5774 responses to predict overall patient satisfaction on their most recent outpatient health services visit over the last 12 months. Potential predictor variables included access to care, costs of care, quality of care, socio-demographic and health care characteristics and health service features. Increase of the mean-squared error (incMSE) due to variable removal was used to assess relative importance of the model variables for accurately predicting patient satisfaction.

Results: The survey data suggest low frequency of dissatisfaction with outpatient services in China (1.8%). Self-reported treatment outcome of the respective visit of a care facility demonstrated to be the strongest predictor for patient satisfaction (incMSE +15%), followed by patient-rated communication (incMSE +2.0%), and then income, waiting time, residency and patient age. Individual patient satisfaction in the survey population was predicted with 74% accuracy using either logistic regression or RF.

Conclusions: Patients' perceived outcomes of health care visits and patient communication with health care professionals are the most important variables associated with patient satisfaction in outpatient health services settings in China.
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http://dx.doi.org/10.1093/fampra/cmaa011DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7474531PMC
September 2020

Excess body weight as a predictor of response to treatment with antidepressants in patients with depressive disorder.

J Affect Disord 2020 04 1;267:153-170. Epub 2020 Feb 1.

Department of Family Medicine, Faculty of Medicine, McGill University, 5858 Chemin de la Côte-des-Neiges, suite 300, H3S 1Z1, Montréal, QC, Canada. Electronic address:

Background: Depression and obesity are debilitating conditions representing an enormous health and economic burden worldwide. Depression is common among patients with excess weight, but more importantly, these patients may be at risk for poor response when treated with antidepressant medications (AD).

Methods: We conducted a comprehensive scoping review to summarize the evidence regarding the difference in response to treatment of depression with AD among patients with excess weight as compared to normal weight patients and to identify knowledge gaps.

Results: The search of the Medline and PsycINFO (2004-2019) identified twelve relevant studies. Tabulation and frequency analysis of the charted data along with a narrative synthesis were performed. Nine studies (75%) reported clinically relevant negative association between patients' high BMI or obesity and treatment response to either nortriptyline, fluoxetine, or various AD; one study (8.3%) reported no difference in response to various AD combinations between BMI groups. One study showed benefits of bupropion and escitalopram combination in patients with morbid obesity (BMI > 35 kg/m) as compared with escitalopram monotherapy. Another study reported benefits when using venlafaxine-XR in patients with morbid obesity. We also acknowledge the possible role of sex and genetic factors predicting AD treatment response.

Limitations: The search was restricted to two most relevant sources, publications in four languages and adult population.

Conclusion: The synthesized data may be useful to physicians in their decision regarding the choice of AD in patients with excess weight. Researchers need to address causality of association between obesity and treatment response to individual AD types.
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http://dx.doi.org/10.1016/j.jad.2020.01.113DOI Listing
April 2020

Pulmonary toxicity in rats following inhalation exposure to poorly soluble particles of low toxicity: Testing at excessive concentrations overwhelming lung clearance?

Regul Toxicol Pharmacol 2020 04 31;112:104590. Epub 2020 Jan 31.

Evonik Resource Efficiency GmbH, Rodenbacher Chaussee 4, 63457, Hanau, Wolfgang, Germany.

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http://dx.doi.org/10.1016/j.yrtph.2020.104590DOI Listing
April 2020

Floquet Hopf Insulators.

Phys Rev Lett 2019 Dec;123(26):266803

Department of Physics, University of California, Berkeley, California 94720, USA.

We predict the existence of a Floquet topological insulator in three-dimensional two-band systems, the Floquet Hopf insulator, which possesses two distinct topological invariants. One is the Hopf Z invariant, a linking number characterizing the (nondriven) Hopf topological insulator. The second invariant is an intrinsically Floquet Z_{2} invariant, and represents a condensed matter realization of the topology underlying the Witten anomaly in particle physics. Both invariants arise from topological defects in the system's time evolution, subject to a process in which defects at different quasienergies exchange even amounts of topological charge. Their contrasting classifications lead to a measurable physical consequence, namely, an unusual bulk-boundary correspondence where gapless edge modes are topologically protected, but may exist at either 0 or π quasienergy. Our results represent a phase of matter beyond the conventional classification of Floquet topological insulators.
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http://dx.doi.org/10.1103/PhysRevLett.123.266803DOI Listing
December 2019

Using Health Information Exchange: Usage and Perceived Usefulness in Primary Care.

Stud Health Technol Inform 2019 Aug;264:709-713

Department of Epidemiology, Biostatistics and Occupational Health, McGill University, Montreal, Quebec, Canada.

Health information exchange (HIE) is seen as an essential technology for improving health care quality and efficiency by allowing exchange of patient-centered data over time and across organizations. The objective of this study was to evaluate the usage and the perceived usefulness of a nationwide HIE in a centralized model that was implemented in 2013 in the province of Quebec, Canada. A mixed-method study was conducted with a longitudinal descriptive analysis of usage data combined with in-depth comparative case study in four selected primary care organizations and two emergency departments. Perceived benefits were reported by users across all dimensions of care performance, including accessibility, efficiency, quality and safety, and patient experience; however, the experience of users was very heterogeneous and strongly associated with the commercial electronic record system available in their work place and the implementation strategy.
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http://dx.doi.org/10.3233/SHTI190315DOI Listing
August 2019

A Deep Learning Model to Triage Screening Mammograms: A Simulation Study.

Radiology 2019 10 6;293(1):38-46. Epub 2019 Aug 6.

From the Department of Electrical Engineering and Computer Science, Massachusetts Institute of Technology, Cambridge, Mass (A.Y., T.S., R.B.); and Department of Radiology, Massachusetts General Hospital, Harvard Medical School, 55 Fruit St, WAC 240, Boston, Mass 02114-2698 (R.M., C.L.).

Background Recent deep learning (DL) approaches have shown promise in improving sensitivity but have not addressed limitations in radiologist specificity or efficiency. Purpose To develop a DL model to triage a portion of mammograms as cancer free, improving performance and workflow efficiency. Materials and Methods In this retrospective study, 223 109 consecutive screening mammograms performed in 66 661 women from January 2009 to December 2016 were collected with cancer outcomes obtained through linkage to a regional tumor registry. This cohort was split by patient into 212 272, 25 999, and 26 540 mammograms from 56 831, 7021, and 7176 patients for training, validation, and testing, respectively. A DL model was developed to triage mammograms as cancer free and evaluated on the test set. A DL-triage workflow was simulated in which radiologists skipped mammograms triaged as cancer free (interpreting them as negative for cancer) and read mammograms not triaged as cancer free by using the original interpreting radiologists' assessments. Sensitivities, specificities, and percentage of mammograms read were calculated, with and without the DL-triage-simulated workflow. Statistics were computed across 5000 bootstrap samples to assess confidence intervals (CIs). Specificities were compared by using a two-tailed test ( < .05) and sensitivities were compared by using a one-sided test with a noninferiority margin of 5% ( < .05). Results The test set included 7176 women (mean age, 57.8 years ± 10.9 [standard deviation]). When reading all mammograms, radiologists obtained a sensitivity and specificity of 90.6% (173 of 191; 95% CI: 86.6%, 94.7%) and 93.5% (24 625 of 26 349; 95% CI: 93.3%, 93.9%). In the DL-simulated workflow, the radiologists obtained a sensitivity and specificity of 90.1% (172 of 191; 95% CI: 86.0%, 94.3%) and 94.2% (24 814 of 26 349; 95% CI: 94.0%, 94.6%) while reading 80.7% (21 420 of 26 540) of the mammograms. The simulated workflow improved specificity ( = .002) and obtained a noninferior sensitivity with a margin of 5% ( < .001). Conclusion This deep learning model has the potential to reduce radiologist workload and significantly improve specificity without harming sensitivity. © RSNA, 2019 See also the editorial by Kontos and Conant in this issue.
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http://dx.doi.org/10.1148/radiol.2019182908DOI Listing
October 2019

One-year test-retest reliability of ten vision tests in Canadian athletes.

F1000Res 2019 9;8:1032. Epub 2019 Jul 9.

Department of Family Medicine, McGill University, Montreal, Canada.

: Vision tests are used in concussion management and baseline testing. Concussions, however, often occur months after baseline testing and reliability studies generally examine intervals limited to days or one week. Our objective was to determine the one-year test-retest reliability of these tests. : We assessed one-year test-retest reliability of ten vision tests in elite Canadian athletes followed by the Institut National du Sport du Quebec. We included athletes who completed two baseline (preseason) annual evaluations by one clinician within 365±30 days. We excluded athletes with any concussion or vision training in between the annual evaluations or presented with any factor that is believed to affect the tests (e.g. migraines). Data were collected from clinical charts. We evaluated test-retest reliability using Intraclass Correlation Coefficient (ICC) and 95% limits of agreement (LoA). We examined nine female and seven male athletes with a mean age of 22.7 (SD 4.5) years. Among the vision tests, we observed excellent test-retest reliability in Positive Fusional Vergence at 30cm (ICC=0.93) but this dropped to 0.53 when an outlier was excluded in a sensitivity analysis. There was good to moderate reliability in Negative Fusional Vergence at 30cm (ICC=0.78), Phoria at 30cm (ICC=0.68), Near Point of Convergence break (ICC=0.65) and Saccades (ICC=0.61). The ICC for Positive Fusional Vergence at 3m (ICC=0.56) also decreased to 0.45 after removing two outliers. We found poor reliability in Near Point of Convergence (ICC=0.47), Gross Stereoscopic Acuity (ICC=0.03) and Negative Fusional Vergence at 3m (ICC=0.0). ICC for Phoria at 3m was not appropriate because scores were identical in 14/16 athletes. 95% LoA of the majority of tests were ±40% to ±90%. Five tests had good to moderate one-year test-retest reliability. The remaining tests had poor reliability. The tests would therefore be useful only if concussion has a moderate-large effect on scores.
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http://dx.doi.org/10.12688/f1000research.19587.5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7484722PMC
February 2021

Impact of health service interventions on acute hospital use in community-dwelling persons with dementia: A systematic literature review and meta-analysis.

PLoS One 2019 21;14(6):e0218426. Epub 2019 Jun 21.

Department of Family Medicine, McGill University, Montreal, Quebec, Canada.

Background: Persons with dementia have twice the acute hospital use as older persons without dementia. In addition to straining overburdened healthcare systems, acute hospital use impacts patient and caregiver quality of life and is associated with increased risk of adverse outcomes including death. Reducing avoidable acute hospital use in persons with dementia is thus a global healthcare priority. However, evidence regarding the impact of health service interventions as defined by the Effective Practice and Organization of Care Cochrane Group on acute hospital use is scant and inconclusive. The aim of this systematic review and meta-analysis was to synthesize available evidence on the impact of health service interventions on acute hospital use in community-dwelling persons with dementia compared to usual care.

Methods: Data Sources: MEDLINE, EMBASE, CINAHL and Cochrane CENTRAL (from 01/1995 to 08/2017). Study eligibility criteria: Randomised controlled trials measuring the impact of health service interventions on acute hospital use (proportion and mean number of emergency department visits and hospitalisations, mean number of hospital days, measured at 12 months, and at longest follow-up) in community-dwelling persons with dementia, compared to usual care. Study selection, appraisal and synthesis methods: Reviewers independently identified studies, extracted data, and assessed the risk of bias, with the Cochrane risk of bias tool. Authors of relevant trials were queried about unpublished data. Random effects model was used for meta-analyses. Effect heterogeneity was assessed through prediction intervals, and explored using sub-group analyses.

Findings: Seventeen trials provided data on 4,549 persons. Unpublished data were obtained for 13 trials, representing 65% of synthesized data. Most interventions included a case management or a self-management component. None of the outcome comparisons provided conclusive evidence supporting the hypothesis that these interventions would lead to a decrease in acute hospital use. Furthermore, prediction intervals indicated possible and important increased service use associated with these interventions, such as emergency department visits, hospital admissions, and hospital days. Subgroup analyses did not favour any type of intervention. A limitation of this study is the inclusion of any type of health service intervention, which may have increased the observed heterogeneity.

Conclusion: Despite a comprehensive systematic review and meta-analysis, including predominantly unpublished data, no health service intervention beyond usual care was found to reduce acute hospital use in community-dwelling persons with dementia. An important increase in service use may be associated with these interventions. Further research is urgently needed to identify effective interventions for this vulnerable population to limit rising acute hospital use, associated costs and adverse outcomes. Systematic review registration PROSPERO CRD42016046444.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0218426PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC6588225PMC
February 2020

Impact of a behavioral intervention, delivered by pediatricians or psychologists, on sleep problems in children with ADHD: a cluster-randomized, translational trial.

J Child Psychol Psychiatry 2019 11 11;60(11):1230-1241. Epub 2019 Jun 11.

Centre for Community Child Health, The Royal Children's Hospital, Parkville, VIC, Australia.

Background: We have demonstrated the efficacy of a brief behavioral intervention for sleep in children with ADHD in a previous randomized controlled trial and now aim to examine whether this intervention is effective and cost-effective when delivered by pediatricians or psychologists in community settings.

Methods: Translational, cluster-randomized trial of a behavioral intervention versus usual care from 19th January, 2015 to 30th June, 2017. Participants (n = 361) were children aged 5-13 years with ADHD and parent report of a moderate/severe sleep problem who met criteria for American Academy of Sleep Medicine criteria for chronic insomnia disorder, delayed sleep-wake phase disorder, or were experiencing sleep-related anxiety. Participants were randomized at the level of the pediatrician (n = 61) to intervention (n = 183) or usual care (n = 178). Families in the intervention group received two consultations with a pediatrician or a psychologist covering sleep hygiene and tailored behavioral strategies.

Results: In an intention-to-treat analysis, at 3 and 6 months respectively, the proportion of children with moderate to severe sleep problems was lower in the intervention (28.0%, 35.8%) compared with usual care group (55.4%, 60.1%; 3 month: risk ratio (RR): 0.51, 95% CI 0.37, 0.70, p < .001; 6 month: RR: 0.58; 95% CI 0.45, 0.76, p < .001). Intervention children had improvements across multiple Children's Sleep Habits Questionnaire subscales at 3 and 6 months. No benefits of the intervention were observed in other domains. Cost-effectiveness of the intervention was AUD 13 per percentage point reduction in child sleep problem at 3 months.

Conclusions: A low-cost brief behavioral sleep intervention is effective in improving sleep problems when delivered by community clinicians. Greater sample comorbidity, lower intervention dose or insufficient clinician supervisions may have contributed to the lack benefits seen in our previous trial.
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http://dx.doi.org/10.1111/jcpp.13083DOI Listing
November 2019