Publications by authors named "Sofia Dias"

113 Publications

Parkinson's Disease Detection Based on Running Speech Data From Phone Calls.

IEEE Trans Biomed Eng 2021 Oct 1;PP. Epub 2021 Oct 1.

Objective: Parkinson's Disease (PD) is a progressive neurodegenerative disorder, manifesting with subtle early signs, which often hinder timely and early diagnosis and treatment. The development of accessible, technology-based methods for longitudinal PD symptoms tracking in daily living offers the potential for transforming the disease assessment and accelerating PD diagnosis.

Methods: A privacy-aware method for classifying PD patients and healthy controls (HC), on the grounds of speech impairment present in PD, is proposed here. Voice features from running speech signals were extracted from recordings passively captured over voice phone calls. Features are fed in a language-aware training of multiple- and single-instance learning classifiers, along with demographic variables, exploiting a multilingual cohort of 498 subjects (392/106 self-reported HC/PD patients) to classify PD.

Results: By means of leave-one-subject-out cross-validation, the best-performing models yielded 0.69/0.68/0.63/0.83 area under the Receiver Operating Characteristic curve (AUC) for the binary classification of PD patient vs. HC in sub-cohorts of English/Greek/German/Portuguese-speaking subjects, respectively. Out-of-sample testing of the best performing models was conducted in an additional dataset, generated by 63 clinically-assessed subjects (24/39 HC/early PD patients). Testing has resulted in 0.84/0.93/0.83 AUC for the English/Greek/German-speaking sub-cohorts, respectively. Comparative analysis with other approaches for language-aware PD detection justified the efficiency of the proposed one, considering the ecological validity of the acquired voice data.

Conclusions: The present work demonstrates increased robustness in PD detection using voice data captured in-the-wild.

Significance: A high-frequency, privacy-aware and unobtrusive PD screening tool is introduced for the first time, based on analysis of voice samples captured during routine phone calls.
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http://dx.doi.org/10.1109/TBME.2021.3116935DOI Listing
October 2021

Improving the Estimation of Subgroup Effects for Clinical Trial Participants with Multimorbidity by Incorporating Drug Class-Level Information in Bayesian Hierarchical Models: A Simulation Study.

Med Decis Making 2021 Aug 18:272989X211029556. Epub 2021 Aug 18.

Institute of Health and Wellbeing, University of Glasgow, Glasgow, UK.

Background: There is limited guidance for using common drug therapies in the context of multimorbidity. In part, this is because their effectiveness for patients with specific comorbidities cannot easily be established using subgroup analyses in clinical trials. Here, we use simulations to explore the feasibility and implications of concurrently estimating effects of related drug treatments in patients with multimorbidity by partially pooling subgroup efficacy estimates across trials.

Methods: We performed simulations based on the characteristics of 161 real clinical trials of noninsulin glucose-lowering drugs for diabetes, estimating subgroup effects for patients with a hypothetical comorbidity across related trials in different scenarios using Bayesian hierarchical generalized linear models. We structured models according to an established ontology-the World Health Organization Anatomic Chemical Therapeutic Classifications-allowing us to nest all trials within drugs and all drugs within anatomic chemical therapeutic classes, with effects partially pooled at each level of the hierarchy. In a range of scenarios, we compared the performance of this model to random effects meta-analyses of all drugs individually.

Results: Hierarchical, ontology-based Bayesian models were unbiased and accurately recovered simulated comorbidity-drug interactions. Compared with single-drug meta-analyses, they offered a relative increase in precision of up to 250% in some scenarios because of information sharing across the hierarchy. Because of the relative precision of the approaches, a large proportion of small subgroup effects was detectable only using the hierarchical model.

Conclusions: By assuming that similar drugs may have similar subgroup effects, Bayesian hierarchical models based on structures defined by existing ontologies can be used to improve the precision of treatment efficacy estimates in patients with multimorbidity, with potential implications for clinical decision making.
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http://dx.doi.org/10.1177/0272989X211029556DOI Listing
August 2021

Cost-effectiveness of point-of-care creatinine testing to assess kidney function prior to contrast-enhanced computed tomography imaging.

Eur J Radiol 2021 Sep 27;142:109872. Epub 2021 Jul 27.

Centre for Health Economics, University of York, Heslington, UK.

Background: Patients undergoing contrast-enhanced computed tomography (CECT) imaging in a non-emergency outpatient setting often lack a recent estimated Glomerular Filtration Rate measurement. This may lead to inefficiencies in the CECT pathway. The use of point-of-care (POC) creatinine tests to evaluate kidney function in these patients may provide a safe and cost-effective alternative to current practice, as these can provide results within the same CECT appointment.

Methods: A decision tree model was developed to characterise the diagnostic pathway and patient management (e.g., intravenous hydration) and link these to adverse renal events associated with intravenous contrast media. Twelve diagnostic strategies including three POC devices (i-STAT, ABL800 Flex and StatSensor), risk factor screening and laboratory testing were compared with current practice. The diagnostic accuracy of POC devices was derived from a systematic review and meta-analysis; relevant literature sources and databases informed other parameters. The cost-effective strategy from a health care perspective was identified based on highest net health benefit (NHB) which were expressed in quality-adjusted life years (QALYs) at £20,000/QALY.

Results: The cost-effective strategy, with a NHB of 9.98 QALYs and a probability of being cost-effective of 79.3%, was identified in our analysis to be a testing sequence involving screening all individuals for risk factors, POC testing (with i-STAT) on those screening positive, and performing a confirmatory laboratory test for individuals with a positive POC result. The incremental NHB of this strategy compared to current practice, confirmatory laboratory test, is 0.004 QALYs. Results were generally robust to scenario analysis.

Conclusions: A testing sequence combining a risk factor questionnaire, POC test and confirmatory laboratory testing appears to be cost-effective compared to current practice. The cost-effectiveness of POC testing appears to be driven by reduced delays within the CECT pathway. The contribution of intravenous contrast media to acute kidney injury, and the benefits and harms of intravenous hydration remain uncertain.
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http://dx.doi.org/10.1016/j.ejrad.2021.109872DOI Listing
September 2021

Methodological review to develop a list of bias items used to assess reviews incorporating network meta-analysis: protocol and rationale.

BMJ Open 2021 06 24;11(6):e045987. Epub 2021 Jun 24.

Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Introduction: Systematic reviews with network meta-analysis (NMA; ie, multiple treatment comparisons, indirect comparisons) have gained popularity and grown in number due to their ability to provide comparative effectiveness of multiple treatments for the same condition. The methodological review aims to develop a list of items relating to biases in reviews with NMA. Such a list will inform a new tool to assess the risk of bias in NMAs, and potentially other reporting or quality checklists for NMAs which are being updated.

Methods And Analysis: We will include articles that present items related to bias, reporting or methodological quality, articles assessing the methodological quality of reviews with NMA, or papers presenting methods for NMAs. We will search Ovid MEDLINE, the Cochrane library and difficult to locate/unpublished literature. Once all items have been extracted, we will combine conceptually similar items, classifying them as referring to bias or to other aspects of quality (eg, reporting). When relevant, reporting items will be reworded into items related to bias in NMA review conclusions, and then reworded as signalling questions.

Ethics And Dissemination: No ethics approval was required. We plan to publish the full study open access in a peer-reviewed journal, and disseminate the findings via social media (Twitter, Facebook and author affiliated websites). Patients, healthcare providers and policy-makers need the highest quality evidence to make decisions about which treatments should be used in healthcare practice. Being able to critically appraise the findings of systematic reviews that include NMA is central to informed decision-making in patient care.
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http://dx.doi.org/10.1136/bmjopen-2020-045987DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8231030PMC
June 2021

Advances on colorectal cancer 3D models: The needed translational technology for nanomedicine screening.

Adv Drug Deliv Rev 2021 08 4;175:113824. Epub 2021 Jun 4.

I3S - Instituto de Investigação e Inovação em Saúde, Universidade do Porto, Rua Alfredo Allen 208, 4200-135 Porto, Portugal; INEB - Instituto de Engenharia Biomédica, Universidade do Porto, Rua Alfredo Allen 208, 4200-135 Porto, Portugal; CESPU - Instituto de Investigação e Formação Avançada em Ciências e Tecnologias da Saúde, Rua Central de Gandra 1317, 4585-116 Gandra, Portugal. Electronic address:

Colorectal cancer (CRC) is a heterogeneous and molecularly complex disease, associated with high mortality worldwide, exposing the urgent need for novel therapeutic approaches. Their development and translation to the clinic have been hampered, partially due to the absence of reliable cellular models that resemble key features of the human disease. While traditional 2D models are not able to provide consistent and predictive responses about the in vivo efficiency of the formulation, animal models frequently fail to recapitulate cancer progression and to reproduce adverse effects. On its turn, multicellular 3D systems, by mimicking key genetic, physical and mechanical cues of the tumor microenvironment, constitute a promising tool in cancer research. In addition, they constitute more physiological and relevant environment for anticancer drugs screening and for predicting patient's response towards personalized approaches, bridging the gap between simplified 2D models and unrepresentative animal models. In this review, we provide an overview of CRC 3D models for translational research, with focus on their potential for nanomedicines screening.
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http://dx.doi.org/10.1016/j.addr.2021.06.001DOI Listing
August 2021

A method for assessing robustness of the results of a star-shaped network meta-analysis under the unidentifiable consistency assumption.

BMC Med Res Methodol 2021 06 1;21(1):113. Epub 2021 Jun 1.

Institute of Health Policy and Management, Medical Research Center, Seoul National University, Seoul, South Korea.

Background: In a star-shaped network, pairwise comparisons link treatments with a reference treatment (often placebo or standard care), but not with each other. Thus, comparisons between non-reference treatments rely on indirect evidence, and are based on the unidentifiable consistency assumption, limiting the reliability of the results. We suggest a method of performing a sensitivity analysis through data imputation to assess the robustness of results with an unknown degree of inconsistency.

Methods: The method involves imputation of data for randomized controlled trials comparing non-reference treatments, to produce a complete network. The imputed data simulate a situation that would allow mixed treatment comparison, with a statistically acceptable extent of inconsistency. By comparing the agreement between the results obtained from the original star-shaped network meta-analysis and the results after incorporating the imputed data, the robustness of the results of the original star-shaped network meta-analysis can be quantified and assessed. To illustrate this method, we applied it to two real datasets and some simulated datasets.

Results: Applying the method to the star-shaped network formed by discarding all comparisons between non-reference treatments from a real complete network, 33% of the results from the analysis incorporating imputed data under acceptable inconsistency indicated that the treatment ranking would be different from the ranking obtained from the star-shaped network. Through a simulation study, we demonstrated the sensitivity of the results after data imputation for a star-shaped network with different levels of within- and between-study variability. An extended usability of the method was also demonstrated by another example where some head-to-head comparisons were incorporated.

Conclusions: Our method will serve as a practical technique to assess the reliability of results from a star-shaped network meta-analysis under the unverifiable consistency assumption.
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http://dx.doi.org/10.1186/s12874-021-01290-1DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8171049PMC
June 2021

Probiotic Greek yogurt: effect of the addition of prebiotic fat substitutes on the physicochemical characteristics, probiotic survival, and sensory acceptance.

J Dairy Res 2021 Feb 17;88(1):98-104. Epub 2021 Feb 17.

Instituto Federal do Paraná, Campus Paranavaí, Rua José Felipe Tequinha, 1400, CEP 87703-536, Paranavaí/PR, Brazil.

In this research communication we evaluate the impact of the addition of prebiotic components (inulin, polydextrose, and modified starch, 40 g/l) as fat substitutes on the physicochemical characteristics, probiotic survival, and sensory acceptance of probiotic (Lacticaseibacillus casei 01, 108 CFU/ml) Greek yogurts during storage (7 °C, 28 d). All formulations had probiotic counts higher than 107 CFU/ml during storage and simulated gastrointestinal conditions (SGIC). The prebiotic components increased the probiotic survival to the enteric phase of the SGIC, with inulin producing the most pronounced effect. Inulin addition resulted in products with lower pH values and consistency and higher titratable acidity during storage, with negative impact on the sensory acceptance (flavor, texture, and overall impression) at the end of the storage period. Modified starch addition impacted negatively on the acceptance of the products (appearance, flavor, texture, and overall impression). Polydextrose addition resulted in products with lower consistency, but similar sensory acceptance to the full-fat yogurt. It can be concluded that it is possible to prepare potentially synbiotic Greek yogurts by desorption technique using L. casei as probiotic culture and inulin, polydextrose or modified starch as prebiotic components, with the utilization of polydextrose being advisable.
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http://dx.doi.org/10.1017/S0022029921000121DOI Listing
February 2021

Assistive HCI-Serious Games Co-design Insights: The Case Study of i-PROGNOSIS Personalized Game Suite for Parkinson's Disease.

Front Psychol 2020 15;11:612835. Epub 2021 Jan 15.

Third Neurological Clinic, G. Papanikolaou Hospital, Thessaloniki, Greece.

Human-Computer Interaction (HCI) and games set a new domain in understanding people's motivations in gaming, behavioral implications of game play, game adaptation to player preferences and needs for increased engaging experiences in the context of HCI serious games (HCI-SGs). When the latter relate with people's health status, they can become a part of their daily life as assistive health status monitoring/enhancement systems. Co-designing HCI-SGs can be seen as a combination of art and science that involves a meticulous collaborative process. The design elements in assistive HCI-SGs for Parkinson's Disease (PD) patients, in particular, are explored in the present work. Within this context, the Game-Based Learning (GBL) design framework is adopted here and its main game-design parameters are explored for the Exergames, Dietarygames, Emotional games, Handwriting games, and Voice games design, drawn from the PD-related i-PROGNOSIS Personalized Game Suite (PGS) (www.i-prognosis.eu) holistic approach. Two main data sources were involved in the study. In particular, the first one includes qualitative data from semi-structured interviews, involving 10 PD patients and four clinicians in the co-creation process of the game design, whereas the second one relates with data from an online questionnaire addressed by 104 participants spanning the whole related spectrum, i.e., PD patients, physicians, software/game developers. Linear regression analysis was employed to identify an adapted GBL framework with the most significant game-design parameters, which efficiently predict the transferability of the PGS beneficial effect to real-life, addressing functional PD symptoms. The findings of this work can assist HCI-SG designers for designing PD-related HCI-SGs, as the most significant game-design factors were identified, in terms of adding value to the role of HCI-SGs in increasing PD patients' quality of life, optimizing the interaction with personalized HCI-SGs and, hence, fostering a collaborative human-computer symbiosis.
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http://dx.doi.org/10.3389/fpsyg.2020.612835DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7843389PMC
January 2021

On weakly informative prior distributions for the heterogeneity parameter in Bayesian random-effects meta-analysis.

Res Synth Methods 2021 Jul 15;12(4):448-474. Epub 2021 Feb 15.

Department of Medical Statistics, University Medical Center Göttingen, Göttingen, Germany.

The normal-normal hierarchical model (NNHM) constitutes a simple and widely used framework for meta-analysis. In the common case of only few studies contributing to the meta-analysis, standard approaches to inference tend to perform poorly, and Bayesian meta-analysis has been suggested as a potential solution. The Bayesian approach, however, requires the sensible specification of prior distributions. While noninformative priors are commonly used for the overall mean effect, the use of weakly informative priors has been suggested for the heterogeneity parameter, in particular in the setting of (very) few studies. To date, however, a consensus on how to generally specify a weakly informative heterogeneity prior is lacking. Here we investigate the problem more closely and provide some guidance on prior specification.
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http://dx.doi.org/10.1002/jrsm.1475DOI Listing
July 2021

Prophylactic antibiotics for adults with chronic obstructive pulmonary disease: a network meta-analysis.

Cochrane Database Syst Rev 2021 01 15;1:CD013198. Epub 2021 Jan 15.

Centre for Reviews and Dissemination, University of York, York, UK.

Background: Chronic obstructive pulmonary disease (COPD) is a chronic respiratory condition characterised by persistent respiratory symptoms and airflow limitation. Acute exacerbations punctuate the natural history of COPD and are associated with increased morbidity and mortality and disease progression. Chronic airflow limitation is caused by a combination of small airways (bronchitis) and parenchymal destruction (emphysema), which can impact day-to-day activities and overall quality of life. In carefully selected patients with COPD, long-term, prophylactic use of antibiotics may reduce bacterial load, inflammation of the airways, and the frequency of exacerbations.

Objectives: To assess effects of different prophylactic antibiotics on exacerbations, quality of life, and serious adverse events in people with COPD in three separate network meta-analyses (NMAs), and to provide rankings of identified antibiotics.

Search Methods: To identify eligible randomised controlled trials (RCTs), we searched the Cochrane Airways Group Specialised Register of trials and clinical trials registries. We conducted the most recent search on 22 January 2020.

Selection Criteria: We included RCTs with a parallel design of at least 12 weeks' duration evaluating long-term administration of antibiotics prophylactically compared with other antibiotics, or placebo, for patients with COPD.

Data Collection And Analysis: This Cochrane Review collected and updated pair-wise data from two previous Cochrane Reviews. Searches were updated and additional studies included. We conducted three separate network meta-analyses (NMAs) within a Bayesian framework to assess three outcomes: exacerbations, quality of life, and serious adverse events. For quality of life, we collected data from St George's Respiratory Questionnaire (SGRQ). Using previously validated methods, we selected the simplest model that could adequately fit the data for every analysis. We used threshold analysis to indicate which results were robust to potential biases, taking into account each study's contributions to the overall results and network structure. Probability ranking was performed for each antibiotic class for exacerbations, quality of life, and serious adverse events.

Main Results: Characteristics of studies and participants Eight trials were conducted at multiple sites that included hospital clinics or academic health centres. Seven were single-centre trials conducted in hospital clinics. Two trials did not report settings. Trials durations ranged from 12 to 52 weeks. Most participants had moderate to severe disease. Mean age ranged from 64 years to 73 years, and more males were recruited (51% to 100%). Forced expiratory volume in one second (FEV₁) ranged from 0.935 to 1.36 L. Most participants had previous exacerbations. Data from 12 studies were included in the NMAs (3405 participants; 16 treatment arms including placebo). Prophylactic antibiotics evaluated were macrolides (azithromycin and erythromycin), tetracyclines (doxycyclines), quinolones (moxifloxacin) and macrolides plus tetracyclines (roxithromycin plus doxycycline). Risk of bias and threshold analysis Most studies were at low risk across domains, except detection bias, for which only seven studies were judged at low risk. In the threshold analysis for exacerbations, all comparisons in which one antibiotic was compared with another were robust to sampling variation, especially macrolide comparisons. Comparisons of classes with placebo were sensitive to potential bias, especially macrolide versus placebo, therefore, any bias in the comparison was likely to favour the active class, so any adjustment would bring the estimated relative effect closer to the null value, thus quinolone may become the best class to prevent exacerbations. Exacerbations Nine studies were included (2732 participants) in this NMA (exacerbations analysed as time to first exacerbation or people with one or more exacerbations). Macrolides and quinolones reduced exacerbations. Macrolides had a greater effect in reducing exacerbations compared with placebo (macrolides: hazard ratio (HR) 0.67, 95% credible interval (CrI) 0.60 to 0.75; quinolones: HR 0.89, 95% CrI 0.75 to 1.04), resulting in 127 fewer people per 1000 experiencing exacerbations on macrolides. The difference in exacerbations between tetracyclines and placebo was uncertain (HR 1.29, 95% CrI 0.66 to 2.41). Macrolides ranked first (95% CrI first to second), with quinolones ranked second (95% CrI second to third). Tetracyclines ranked fourth, which was lower than placebo (ranked third). Contributing studies were considered as low risk of bias in a threshold analysis. Quality of life (SGRQ) Seven studies were included (2237 participants) in this NMA. SGRQ scores improved with macrolide treatment compared with placebo (fixed effect-fixed class effect: mean difference (MD) -2.30, 95% CrI -3.61 to -0.99), but the mean difference did not reach the minimally clinical important difference (MCID) of 4 points. Tetracyclines and quinolones did not improve quality of life any more than placebo, and we did not detect a difference between antibiotic classes. Serious adverse events Nine studies were included (3180 participants) in the NMA. Macrolides reduced the odds of a serious adverse event compared with placebo (fixed effect-fixed class effect: odds ratio (OR) 0.76, 95% CrI 0.62 to 0.93). There was probably little to no difference in the effect of quinolone compared with placebo or tetracycline plus macrolide compared with placebo. There was probably little to no difference in serious adverse events between quinolones or tetracycline plus macrolide. With macrolide treatment 49 fewer people per 1000 experienced a serious adverse event compared with those given placebo. Macrolides ranked first, followed by quinolones. Tetracycline did not rank better than placebo. Drug resistance Ten studies reported drug resistance. Results were not combined due to variation in outcome measures. All studies concluded that prophylactic antibiotic administration was associated with the development of antimicrobial resistance.

Authors' Conclusions: This NMA evaluated the safety and efficacy of different antibiotics used prophylactically for COPD patients. Compared to placebo, prolonged administration of macrolides (ranked first) appeared beneficial in prolonging the time to next exacerbation, improving quality of life, and reducing serious adverse events. No clear benefits were associated with use of quinolones or tetracyclines. In addition, antibiotic resistance was a concern and could not be thoroughly assessed in this review. Given the trade-off between effectiveness, safety, and risk of antibiotic resistance, prophylactic administration of antibiotics may be best reserved for selected patients, such as those experiencing frequent exacerbations. However, none of the eligible studies excluded patients with previously isolated non-tuberculous mycobacteria, which would contraindicate prophylactic administration of antibiotics, due to the risk of developing resistant non-tuberculous mycobacteria.
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http://dx.doi.org/10.1002/14651858.CD013198.pub2DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC8092479PMC
January 2021

Joining the Dots: Linking Disconnected Networks of Evidence Using Dose-Response Model-Based Network Meta-Analysis.

Med Decis Making 2021 02 15;41(2):194-208. Epub 2021 Jan 15.

Department of Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Background: Network meta-analysis (NMA) synthesizes direct and indirect evidence on multiple treatments to estimate their relative effectiveness. However, comparisons between disconnected treatments are not possible without making strong assumptions. When studies including multiple doses of the same drug are available, model-based NMA (MBNMA) presents a novel solution to this problem by modeling a parametric dose-response relationship within an NMA framework. In this article, we illustrate several scenarios in which dose-response MBNMA can connect and strengthen evidence networks.

Methods: We created illustrative data sets by removing studies or treatments from an NMA of triptans for migraine relief. We fitted MBNMA models with different dose-response relationships. For connected networks, we compared MBNMA estimates with NMA estimates. For disconnected networks, we compared MBNMA estimates with NMA estimates from an "augmented" network connected by adding studies or treatments back into the data set.

Results: In connected networks, relative effect estimates from MBNMA were more precise than those from NMA models (ratio of posterior SDs NMA v. MBNMA: median = 1.13; range = 1.04-1.68). In disconnected networks, MBNMA provided estimates for all treatments where NMA could not and were consistent with NMA estimates from augmented networks for 15 of 18 data sets. In the remaining 3 of 18 data sets, a more complex dose-response relationship was required than could be fitted with the available evidence.

Conclusions: Where information on multiple doses is available, MBNMA can connect disconnected networks and increase precision while making less strong assumptions than alternative approaches. MBNMA relies on correct specification of the dose-response relationship, which requires sufficient data at different doses to allow reliable estimation. We recommend that systematic reviews for NMA search for and include evidence (including phase II trials) on multiple doses of agents where available.
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http://dx.doi.org/10.1177/0272989X20983315DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879230PMC
February 2021

Exploring Heterogeneity in Histology-Independent Technologies and the Implications for Cost-Effectiveness.

Med Decis Making 2021 02 13;41(2):165-178. Epub 2021 Jan 13.

Centre for Reviews and Dissemination, University of York, York, Yorkshire, UK.

Background: The National Institute for Health and Care Excellence and a number of international health technology assessment agencies have recently undertaken appraisals of histology-independent technologies (HITs). A strong and untested assumption inherent in the submissions included identical clinical response across all tumour histologies, including new histologies unrepresented in the trial. Challenging this assumption and exploring the potential for heterogeneity has the potential to impact upon cost-effectiveness.

Method: Using published response data for a HIT, a Bayesian hierarchical model (BHM) was used to identify heterogeneity in response and to estimate the probability of response for each histology included in single-arm studies, which informed the submission for the HIT, larotrectinib. The probability of response for a new histology was estimated. Results were inputted into a simplified response-based economic model using hypothetical parameters. Histology-independent and histology-specific incremental cost-effectiveness ratios accounting for heterogeneity were generated.

Results: The results of the BHM show considerable heterogeneity in response rates across histologies. The predicted probability of response estimated by the BHM is 60.9% (95% credible interval 16.0; 91.8%), lower than the naively pooled probability of 74.5%. A mean response probability of 56.9% (0.2; 99.9%) is predicted for an unrepresented histology. Based on the economic analysis, the probability of the hypothetical HIT being cost-effective under the assumption of identical response is 78%. Allowing for heterogeneity, the probability of various approval decisions being cost-effective ranges from 93% to 11%.

Conclusions: Central to the challenge of reimbursement of HITs is the potential for heterogeneity. This study illustrates how heterogeneity in clinical effectiveness can result in highly variable and uncertain estimates of cost-effectiveness. This analysis can help improve understanding of the consequences of histology-independent versus histology-specific decisions.
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http://dx.doi.org/10.1177/0272989X20980327DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7879234PMC
February 2021

"Life" beyond classical test theory: some considerations on using complementary psychometric approaches in sleep medicine.

Sleep Med 2021 03 13;79:225-226. Epub 2020 Nov 13.

University of Aveiro, Department of Education and Psychology, Campus Universitário de Santiago, 3810-193 Aveiro, Portugal; CINEICC - Center for Research in Neuropsychology and Cognitive Behavioral Intervention, Faculty of Psychology and Educational Sciences, University of Coimbra, Portugal. Electronic address:

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http://dx.doi.org/10.1016/j.sleep.2020.11.012DOI Listing
March 2021

Livestock Wastewater Treatment in Constructed Wetlands for Agriculture Reuse.

Int J Environ Res Public Health 2020 11 19;17(22). Epub 2020 Nov 19.

CIIMAR-Interdisciplinary Centre of Marine and Environmental Research of the University of Porto, Terminal de Cruzeiros do Porto de Leixões, Avenida General Norton de Matos, 4450-208 Matosinhos, Portugal.

The aim of this study focused on the evaluation of constructed wetlands (CWs) microcosms, on a laboratory scale, for the removal of metals from a pig industry effluent while maintaining effluent organic matter and nutrients levels for its later used as a fertilizer. CWs with different macrophytes ( and ) and different substrates (light expanded clay aggregate and lava rock) were tested. Results showed high removals of metals during CWs treatment, with removal rates reaching >80% for Cd, Cr, Cu, Fe, Mn, and Zn after 2 days of treatment in CWs planted with and >60% in CWs planted with . Significant differences were only found between substrates for Fe and Mn in CWs with . Removal of organic matter (through chemical oxygen demand (COD)) was >77%, with no significant differences between substrates or plants. Removals of ammonium and phosphate ions ranged between 59-84% and 32-92%, respectively, in CWs with and 62-75% and 7-68% in CWs with , with no significant differences between substrates. Overall, CWs showed potential to be efficient in removing toxic contaminants, as metals, while maintaining moderated levels of nutrients, allowing the use of reclaimed water in agriculture, namely as fertilizer. If one aims for a short CW treatment, CW planted with and expanded clay as substrate could be the more suitable choice.
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http://dx.doi.org/10.3390/ijerph17228592DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7699426PMC
November 2020

DeepLMS: a deep learning predictive model for supporting online learning in the Covid-19 era.

Sci Rep 2020 11 16;10(1):19888. Epub 2020 Nov 16.

Department of Electrical Engineering and Computer Science, Khalifa University of Science and Technology, Abu Dhabi, UAE.

Coronavirus (Covid-19) pandemic has imposed a complete shut-down of face-to-face teaching to universities and schools, forcing a crash course for online learning plans and technology for students and faculty. In the midst of this unprecedented crisis, video conferencing platforms (e.g., Zoom, WebEx, MS Teams) and learning management systems (LMSs), like Moodle, Blackboard and Google Classroom, are being adopted and heavily used as online learning environments (OLEs). However, as such media solely provide the platform for e-interaction, effective methods that can be used to predict the learner's behavior in the OLEs, which should be available as supportive tools to educators and metacognitive triggers to learners. Here we show, for the first time, that Deep Learning techniques can be used to handle LMS users' interaction data and form a novel predictive model, namely DeepLMS, that can forecast the quality of interaction (QoI) with LMS. Using Long Short-Term Memory (LSTM) networks, DeepLMS results in average testing Root Mean Square Error (RMSE) [Formula: see text], and average correlation coefficient between ground truth and predicted QoI values [Formula: see text] [Formula: see text], when tested on QoI data from one database pre- and two ones during-Covid-19 pandemic. DeepLMS personalized QoI forecasting scaffolds user's online learning engagement and provides educators with an evaluation path, additionally to the content-related assessment, enriching the overall view on the learners' motivation and participation in the learning process.
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http://dx.doi.org/10.1038/s41598-020-76740-9DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7669866PMC
November 2020

Assessing the performance of population adjustment methods for anchored indirect comparisons: A simulation study.

Stat Med 2020 12 4;39(30):4885-4911. Epub 2020 Oct 4.

Bristol Medical School (Population Health Sciences), University of Bristol, Bristol, UK.

Standard network meta-analysis and indirect comparisons combine aggregate data from multiple studies on treatments of interest, assuming that any factors that interact with treatment effects (effect modifiers) are balanced across populations. Population adjustment methods such as multilevel network meta-regression (ML-NMR), matching-adjusted indirect comparison (MAIC), and simulated treatment comparison (STC) relax this assumption using individual patient data from one or more studies, and are becoming increasingly prevalent in health technology appraisals and the applied literature. Motivated by an applied example and two recent reviews of applications, we undertook an extensive simulation study to assess the performance of these methods in a range of scenarios under various failures of assumptions. We investigated the impact of varying sample size, missing effect modifiers, strength of effect modification and validity of the shared effect modifier assumption, validity of extrapolation and varying between-study overlap, and different covariate distributions and correlations. ML-NMR and STC performed similarly, eliminating bias when the requisite assumptions were met. Serious concerns are raised for MAIC, which performed poorly in nearly all simulation scenarios and may even increase bias compared with standard indirect comparisons. All methods incur bias when an effect modifier is missing, highlighting the necessity of careful selection of potential effect modifiers prior to analysis. When all effect modifiers are included, ML-NMR and STC are robust techniques for population adjustment. ML-NMR offers additional advantages over MAIC and STC, including extending to larger treatment networks and producing estimates in any target population, making this an attractive choice in a variety of scenarios.
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http://dx.doi.org/10.1002/sim.8759DOI Listing
December 2020

Outcomes of patients with confirmed SARS-CoV-2 infection undergoing anesthesia: A pilot study.

J Clin Anesth 2020 Dec 14;67:110041. Epub 2020 Sep 14.

Department of Anesthesiology, Centro Hospitalar Universitário São João, Porto, Portugal; Faculty of Medicine, Porto University, Porto, Portugal.

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http://dx.doi.org/10.1016/j.jclinane.2020.110041DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7489923PMC
December 2020

Point-of-care creatinine tests to assess kidney function for outpatients requiring contrast-enhanced CT imaging: systematic reviews and economic evaluation.

Health Technol Assess 2020 08;24(39):1-248

Centre for Health Economics (CHE), University of York, York, UK.

Background: Patients with low estimated glomerular filtration rates may be at higher risk of post-contrast acute kidney injury following contrast-enhanced computed tomography imaging. Point-of-care devices allow rapid measurement of estimated glomerular filtration rates for patients referred without a recent estimated glomerular filtration rate result.

Objectives: To assess the clinical effectiveness and cost-effectiveness of point-of-care creatinine tests for outpatients without a recent estimated glomerular filtration rate measurement who need contrast-enhanced computed tomography imaging.

Methods: Three systematic reviews of test accuracy, implementation and clinical outcomes, and economic analyses were carried out. Bibliographic databases were searched from inception to November 2018. Studies comparing the accuracy of point-of-care creatinine tests with laboratory reference tests to assess kidney function in adults in a non-emergency setting and studies reporting implementation and clinical outcomes were included. Risk of bias of diagnostic accuracy studies was assessed using a modified version of the Quality Assessment of Diagnostic Accuracy Studies 2 (QUADAS-2) tool. Probabilities of individuals having their estimated glomerular filtration rates correctly classified were estimated within a Bayesian framework and pooled using a fixed-effects model. A de novo probabilistic decision tree cohort model was developed to characterise the decision problem from an NHS and a Personal Social Services perspective. A range of alternative point-of-care testing approaches were considered. Scenario analyses were conducted.

Results: Fifty-four studies were included in the clinical reviews. Twelve studies reported diagnostic accuracy for estimated glomerular filtration rates; half were rated as being at low risk of bias, but there were applicability concerns for most. i-STAT (Abbott Point of Care, Inc., Princeton, NJ, USA) and ABL (Radiometer Ltd, Crawley, UK) devices had higher probabilities of correctly classifying individuals in the same estimated glomerular filtration rate categories as the reference laboratory test than StatSensor devices (Nova Biomedical, Runcorn, UK). There was limited evidence for epoc (Siemens Healthineers AG, Erlangen, Germany) and Piccolo Xpress (Abaxis, Inc., Union City, CA, USA) devices and no studies of DRI-CHEM NX 500 (Fujifilm Corporation, Tokyo, Japan). The review of implementation and clinical outcomes included six studies showing practice variation in the management decisions when a point-of-care device indicated an abnormal estimated glomerular filtration rate. The review of cost-effectiveness evidence identified no relevant studies. The de novo decision model that was developed included a total of 14 strategies. Owing to limited data, the model included only i-STAT, ABL800 FLEX and StatSensor. In the base-case analysis, the cost-effective strategy appeared to be a three-step testing sequence involving initially screening all individuals for risk factors, point-of-care testing for those individuals with at least one risk factor, and including a final confirmatory laboratory test for individuals with a point-of-care-positive test result. Within this testing approach, the specific point-of-care device with the highest net benefit was i-STAT, although differences in net benefit with StatSensor were very small.

Limitations: There was insufficient evidence for patients with estimated glomerular filtration rates < 30 ml/minute/1.73 m, and on the full potential health impact of delayed or rescheduled computed tomography scans or the use of alternative imaging modalities.

Conclusions: A three-step testing sequence combining a risk factor questionnaire with a point-of-care test and confirmatory laboratory testing appears to be a cost-effective use of NHS resources compared with current practice. The risk of contrast causing acute kidney injury to patients with an estimated glomerular filtration rate of < 30 ml/minute/1.73 m is uncertain. Cost-effectiveness of point-of-care testing appears largely driven by the potential of point-of-care tests to minimise delays within the current computed tomography pathway.

Future Work: Studies evaluating the impact of risk-stratifying questionnaires on workflow outcomes in computed tomography patients without recent estimated glomerular filtration rate results are needed.

Study Registration: This study is registered as PROSPERO CRD42018115818.

Funding: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in ; Vol. 24, No. 39. See the NIHR Journals Library website for further project information.
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http://dx.doi.org/10.3310/hta24390DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7475798PMC
August 2020

Multilevel network meta-regression for population-adjusted treatment comparisons.

J R Stat Soc Ser A Stat Soc 2020 Jun 7;183(3):1189-1210. Epub 2020 Jun 7.

University of Bristol UK.

Standard network meta-analysis (NMA) and indirect comparisons combine aggregate data from multiple studies on treatments of interest, assuming that any effect modifiers are balanced across populations. Population adjustment methods relax this assumption using individual patient data from one or more studies. However, current matching-adjusted indirect comparison and simulated treatment comparison methods are limited to pairwise indirect comparisons and cannot predict into a specified target population. Existing meta-regression approaches incur aggregation bias. We propose a new method extending the standard NMA framework. An individual level regression model is defined, and aggregate data are fitted by integrating over the covariate distribution to form the likelihood. Motivated by the complexity of the closed form integration, we propose a general numerical approach using quasi-Monte-Carlo integration. Covariate correlation structures are accounted for by using copulas. Crucially for decision making, comparisons may be provided in any target population with a given covariate distribution. We illustrate the method with a network of plaque psoriasis treatments. Estimated population-average treatment effects are similar across study populations, as differences in the distributions of effect modifiers are small. A better fit is achieved than a random effects NMA, uncertainty is substantially reduced by explaining within- and between-study variation, and estimates are more interpretable.
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http://dx.doi.org/10.1111/rssa.12579DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7362893PMC
June 2020

Fluid and pharmacological agents for adhesion prevention after gynaecological surgery.

Cochrane Database Syst Rev 2020 07 17;7:CD001298. Epub 2020 Jul 17.

Department of Obstetrics and Gynaecology, Tameside & Glossop Acute Services NHS Trust, Ashton-Under-Lyne, UK.

Background: Adhesions are fibrin bands that are a common consequence of gynaecological surgery. They are caused by conditions that include pelvic inflammatory disease and endometriosis. Adhesions are associated with comorbidities, including pelvic pain, subfertility, and small bowel obstruction. Adhesions also increase the likelihood of further surgery, causing distress and unnecessary expenses. Strategies to prevent adhesion formation include the use of fluid (also called hydroflotation) and gel agents, which aim to prevent healing tissues from touching one another, or drugs, aimed to change an aspect of the healing process, to make adhesions less likely to form.

Objectives: To evaluate the effectiveness and safety of fluid and pharmacological agents on rates of pain, live births, and adhesion prevention in women undergoing gynaecological surgery.

Search Methods: We searched: the Cochrane Gynaecology and Fertility Specialised Register, CENTRAL, MEDLINE, Embase, PsycINFO, and Epistemonikos to 22 August 2019. We also checked the reference lists of relevant papers and contacted experts in the field.

Selection Criteria: Randomised controlled trials investigating the use of fluid (including gel) and pharmacological agents to prevent adhesions after gynaecological surgery.

Data Collection And Analysis: We used standard methodological procedures recommended by Cochrane. We assessed the overall quality of the evidence using GRADE methods. Outcomes of interest were pelvic pain; live birth rates; incidence of, mean, and changes in adhesion scores at second look-laparoscopy (SLL); clinical pregnancy, miscarriage, and ectopic pregnancy rates; quality of life at SLL; and adverse events.

Main Results: We included 32 trials (3492 women), and excluded 11. We were unable to include data from nine studies in the statistical analyses, but the findings of these studies were broadly in keeping with the findings of the meta-analyses. Hydroflotation agents versus no hydroflotation agents (10 RCTs) We are uncertain whether hydroflotation agents affected pelvic pain (odds ratio (OR) 1.05, 95% confidence interval (CI) 0.52 to 2.09; one study, 226 women; very low-quality evidence). It is unclear whether hydroflotation agents affected live birth rates (OR 0.67, 95% CI 0.29 to 1.58; two studies, 208 women; low-quality evidence) compared with no treatment. Hydroflotation agents reduced the incidence of adhesions at SLL when compared with no treatment (OR 0.34, 95% CI 0.22 to 0.55, four studies, 566 women; high-quality evidence). The evidence suggests that in women with an 84% chance of having adhesions at SLL with no treatment, using hydroflotation agents would result in 54% to 75% having adhesions. Hydroflotation agents probably made little or no difference to mean adhesion score at SLL (standardised mean difference (SMD) -0.06, 95% CI -0.20 to 0.09; four studies, 722 women; moderate-quality evidence). It is unclear whether hydroflotation agents affected clinical pregnancy rate (OR 0.64, 95% CI 0.36 to 1.14; three studies, 310 women; moderate-quality evidence) compared with no treatment. This suggests that in women with a 26% chance of clinical pregnancy with no treatment, using hydroflotation agents would result in a clinical pregnancy rate of 11% to 28%. No studies reported any adverse events attributable to the intervention. Gel agents versus no treatment (12 RCTs) No studies in this comparison reported pelvic pain or live birth rate. Gel agents reduced the incidence of adhesions at SLL compared with no treatment (OR 0.26, 95% CI 0.12 to 0.57; five studies, 147 women; high-quality evidence). This suggests that in women with an 84% chance of having adhesions at SLL with no treatment, the use of gel agents would result in 39% to 75% having adhesions. It is unclear whether gel agents affected mean adhesion scores at SLL (SMD -0.50, 95% CI -1.09 to 0.09; four studies, 159 women; moderate-quality evidence), or clinical pregnancy rate (OR 0.20, 95% CI 0.02 to 2.02; one study, 30 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Gel agents versus hydroflotation agents when used as an instillant (3 RCTs) No studies in this comparison reported pelvic pain, live birth rate or clinical pregnancy rate. Gel agents probably reduce the incidence of adhesions at SLL when compared with hydroflotation agents (OR 0.50, 95% CI 0.31 to 0.83; three studies, 538 women; moderate-quality evidence). This suggests that in women with a 46% chance of having adhesions at SLL with a hydroflotation agent, the use of gel agents would result in 21% to 41% having adhesions. We are uncertain whether gel agents improved mean adhesion scores at SLL when compared with hydroflotation agents (MD -0.79, 95% CI -0.82 to -0.76; one study, 77 women; very low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention. Steroids (any route) versus no steroids (4 RCTs) No studies in this comparison reported pelvic pain, incidence of adhesions at SLL or mean adhesion score at SLL. It is unclear whether steroids affected live birth rates compared with no steroids (OR 0.65, 95% CI 0.26 to 1.62; two studies, 223 women; low-quality evidence), or clinical pregnancy rates (OR 1.01, 95% CI 0.66 to 1.55; three studies, 410 women; low-quality evidence). No studies in this comparison reported on adverse events attributable to the intervention.

Authors' Conclusions: Gels and hydroflotation agents appear to be effective adhesion prevention agents for use during gynaecological surgery, but we found no evidence indicating that they improve fertility outcomes or pelvic pain, and further research is required in this area. It is also worth noting that for some comparisons, wide confidence intervals crossing the line of no effect meant that clinical harm as a result of interventions could not be excluded. Future studies should measure outcomes in a uniform manner, using the modified American Fertility Society score. Statistical findings should be reported in full. No studies reported any adverse events attributable to intervention.
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http://dx.doi.org/10.1002/14651858.CD001298.pub5DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7388178PMC
July 2020

Performance of model-based network meta-analysis (MBNMA) of time-course relationships: A simulation study.

Res Synth Methods 2020 Sep 4;11(5):678-697. Epub 2020 Aug 4.

Department Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, UK.

Time-course model-based network meta-analysis (MBNMA) has been proposed as a framework to combine treatment comparisons from a network of randomized controlled trials reporting outcomes at multiple time-points. This can explain heterogeneity/inconsistency that arises by pooling studies with different follow-up times and allow inclusion of studies from earlier in drug development. The aim of this study is to explore using simulation: (a) how MBNMA model parameters are affected by the quantity/location of observed time-points across studies/comparisons, (b) how reliably an appropriate MBNMA model can be identified, (c) the robustness of model estimates and predictions under different dataset characteristics. Our results indicate that model parameters for a given treatment comparison are estimated with low mean bias even when no direct evidence was available, provided there was sufficient indirect evidence to estimate the time-course. A staged model selection strategy that selects time-course function, then heterogeneity, then covariance structure, identified the true model most reliably and efficiently. Predictions and parameter estimates from selected models had low mean bias even in the presence of high heterogeneity/correlation between time-points. However, failure to properly account for heterogeneity/correlation could lead to high error in precision of the estimates. Time-course MBNMA provides a statistically robust framework for synthesizing direct and indirect evidence to estimate relative effects and predicted mean responses whilst accounting for time-course and incorporating correlation and heterogeneity. This supports the use of MBNMA in evidence synthesis, particularly when additional studies are available with follow-up times that would otherwise prohibit their inclusion by conventional meta-analysis.
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http://dx.doi.org/10.1002/jrsm.1432DOI Listing
September 2020

Layperson-Led vs Professional-Led Behavioral Interventions for Weight Loss in Pediatric Obesity: A Systematic Review and Meta-analysis.

JAMA Netw Open 2020 07 1;3(7):e2010364. Epub 2020 Jul 1.

George & Fay Yee Centre for Healthcare Innovation, Winnipeg, Manitoba, Canada.

Importance: The appropriate approach for weight loss among children and adolescents with overweight and obesity remains unclear.

Objective: To evaluate the difference in the treatment outcomes associated with behavioral weight loss interventions led by laypersons and professionals in comparison with unsupervised control arms among children and adolescents with overweight and obesity.

Data Sources: For this systematic review and meta-analysis, the Medical Literature Analysis and Retrieval System Online (MEDLINE), Embase, the Cochrane Library, and Cumulative Index of Nursing and Allied Health Literature (CINAHL) databases were searched from January 1, 1996, to June 1, 2019.

Study Selection: Included in this study were randomized clinical trials (RCTs) of behavioral interventions lasting at least 12 weeks for children and adolescents (aged 5-18 years) with overweight and obesity. Exclusion criteria included non-RCT studies, interventions lasting less than 12 weeks, adult enrollment, participants with other medical diagnoses, pharmacological treatment use, and articles not written in English. Two of 6 reviewers independently screened all citations. Of 25 586 citations, after duplicate removal, 78 RCTs (5780 participants) met eligibility criteria.

Data Extraction And Synthesis: A bayesian framework and Markov chain Monte Carlo simulation methods were used to combine direct and indirect associations. Random-effects and fixed-effect network meta-analysis models were used with the preferred model chosen by comparing the deviance information criteria. This study was registered with the International Prospective Register of Systematic Reviews (PROSPERO) and followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) reporting guideline.

Main Outcomes And Measures: The immediate and sustained changes in weight and body mass index (BMI) standardized mean difference (SMD) were primary outcomes planned before data collection began, whereas waist circumference and percent body fat were secondary outcomes. The hypothesis being tested was formulated before the data collection.

Results: Of 25 586 citations retrieved, we included 78 RCTs (5780 participants), with a follow-up of 12 to 104 weeks. Compared with the control condition, random-effects models revealed that professional-led weight loss interventions were associated with reductions in weight (mean difference [MD], -1.60 kg [95% CI, -2.30 to -0.99 kg]; 68 trials; P < .001) and BMI (SMD, -0.30 [95% CI, -0.39 to -0.20]; 59 trials; P < .001) that were not sustained long term (weight MD, -1.02 kg [95% CI, -2.20 to 0.34 kg]; 21 trials; P = .06; BMI SMD, -0.12 [95% CI, -0.46 to 0.21]; 20 trials; P < .001). There was no association between layperson-led interventions and weight loss in the short-term (MD, -1.40 kg [95% CI, -3.00 to 0.26 kg]; 5 trials; P = .05) or long-term (MD, -0.98 kg [95% CI, -3.60 to 1.80 kg]; 1 trial; P = .23) compared with standard care. No difference was found in head-to-head trials (professional vs layperson MD, -0.25 kg [95% CI -1.90 to 1.30 kg]; 5 trials; P = .38).

Conclusions And Relevance: This systematic review and meta-analysis found that professional-led weight loss interventions were associated with short-term but not sustained weight reduction among children and adolescents with overweight or obesity, and the evidence for layperson-led approaches was insufficient to draw firm conclusions.
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http://dx.doi.org/10.1001/jamanetworkopen.2020.10364DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7358915PMC
July 2020

Efficacy and acceptability of pharmacological and non-pharmacological interventions for non-specific chronic low back pain: a protocol for a systematic review and network meta-analysis.

Syst Rev 2020 06 5;9(1):130. Epub 2020 Jun 5.

Meta-Research Innovation Center at Stanford (METRICS) and Departments of Medicine, Health Research and Policy, Biomedical Science and Statistics, Stanford University, Stanford, CA, USA.

Background: Despite the enormous financial and humanistic burden of chronic low back pain (CLBP), there is little consensus on what constitutes the best treatment options from a multitude of competing interventions. The objective of this network meta-analysis (NMA) is to determine the relative efficacy and acceptability of primary care treatments for non-specific CLBP, with the overarching aim of providing a comprehensive evidence base for informing treatment decisions.

Methods: We will perform a systematic search to identify randomised controlled trials of interventions endorsed in primary care guidelines for the treatment of non-specific CLBP in adults. Information sources searched will include major bibliographic databases (MEDLINE, Embase, CENTRAL, CINAHL, PsycINFO and LILACS) and clinical trial registries. Our primary outcomes will be patient-reported pain ratings and treatment acceptability (all-cause discontinuation), and secondary outcomes will be functional ability, quality of life and patient/physician ratings of overall improvement. A hierarchical Bayesian class-based NMA will be performed to determine the relative effects of different classes of pharmacological (NSAIDs, opioids, paracetamol, anti-depressants, muscle relaxants) and non-pharmacological (exercise, patient education, manual therapies, psychological therapy, multidisciplinary approaches, massage, acupuncture, mindfulness) interventions and individual treatments within a class (e.g. NSAIDs: diclofenac, ibuprofen, naproxen). We will conduct risk of bias assessments and threshold analysis to assess the robustness of the findings to potential bias. We will compute the effect of different interventions relative to placebo/no treatment for both short- and long-term efficacy and acceptability.

Discussion: While many factors are important in selecting an appropriate intervention for an individual patient, evidence for the analgesic effects and acceptability of a treatment are key factors in guiding this selection. Thus, this NMA will provide an important source of evidence to inform treatment decisions and future clinical guidelines.

Systematic Review Registration: PROSPERO registry number: CRD42019138115.
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http://dx.doi.org/10.1186/s13643-020-01398-3DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275431PMC
June 2020

Patient characteristics as effect modifiers for psoriasis biologic treatment response: an assessment using network meta-analysis subgroups.

Syst Rev 2020 06 5;9(1):132. Epub 2020 Jun 5.

Centre for Reviews and Dissemination, University of York, York, YO10 5DD, UK.

Background: Network meta-analyses (NMAs) of psoriasis treatments, undertaken as part of the NICE Single Technology Appraisal (STA) process, have included heterogeneous studies. When there is inconsistency or heterogeneity across the different comparisons or trials within the network of studies, the results of the NMA may not be valid. We explored the impact of including studies with heterogeneous patient characteristics on the results of NMAs of psoriasis treatments.

Methods: All NMAs undertaken for psoriasis STAs were identified and the included studies tabulated, including patient characteristics that may influence relative treatment effects. In addition to the original network of all studies using licensed treatment doses, a range of smaller, less heterogeneous networks were mapped: 'no previous biologic use' (< 25% patients had prior biologic therapy exposure), 'Psoriasis Area and Severity Index score ≤ 25', 'weight ≤ 90 kg' and 'white ethnicity' (≥ 90% patients were white).

Results: Sixty-nine studies were included in our synthesis (34,924 participants). A random effects model with a log-normal prior distribution was chosen for each of the subgroup NMAs. Heterogeneity was reduced for the four smaller networks. There were no significant differences in the relative treatment effect (PASI 75 response) for each treatment across the five NMAs, with all credible intervals overlapping, although there were noticeable differences. Treatment rankings based on the median relative risks were also generally consistent across the networks. However, the NMA that included only studies in which < 25% patients had prior biologic therapy exposure had slightly different treatment rankings; the anti-TNF therapies certolizumab pegol and infliximab ranked higher in this network than any other network, although credible intervals were large.

Conclusions: This work has highlighted potential differences in treatment response for biologic-naïve patients. When conducting NMAs in any area, heterogeneity in patient characteristics of included trials should be carefully assessed and effect modification related to certain patient characteristics investigated through clinically relevant subgroup analyses.
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http://dx.doi.org/10.1186/s13643-020-01395-6DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7275463PMC
June 2020

Equivalence of entropy balancing and the method of moments for matching-adjusted indirect comparison.

Res Synth Methods 2020 Jul 27;11(4):568-572. Epub 2020 May 27.

Bristol Medical School (Population Health Sciences), University of Bristol, Bristol, UK.

Indirect comparisons are used to obtain estimates of relative effectiveness between two treatments that have not been compared in the same randomized controlled trial, but have instead been compared against a common comparator in separate trials. Standard indirect comparisons use only aggregate data, under the assumption that there are no differences in effect-modifying variables between the trial populations. Population-adjusted indirect comparisons aim to relax this assumption by using individual patient data (IPD) from one trial to adjust for differences in effect modifiers between populations. At present, the most commonly used approach is matching-adjusted indirect comparison (MAIC), where weights are estimated that match the covariate distributions of the reweighted IPD to the aggregate trial. MAIC was originally proposed using the method of moments to estimate the weights, but more recently entropy balancing has been proposed as an alternative. Entropy balancing has an additional "optimality" property ensuring that the weights are as uniform as possible, reducing the standard error of the estimates. In this brief method note, we show that MAIC weights are mathematically identical whether estimated using entropy balancing or the method of moments. Importantly, this means that the standard MAIC (based on the method of moments) also enjoys the "optimality" property. Moreover, the additional flexibility of entropy balancing suggests several interesting avenues for further research, such as combining population adjustment via MAIC with adjustments for treatment switching or nonparametric covariate adjustment.
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http://dx.doi.org/10.1002/jrsm.1416DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7384548PMC
July 2020

Cost-effectiveness of psychological treatments for post-traumatic stress disorder in adults.

PLoS One 2020 30;15(4):e0232245. Epub 2020 Apr 30.

Centre for Outcomes Research and Effectiveness, Research Department of Clinical, Educational & Health Psychology, University College London, London, United Kingdom.

Background: Post-traumatic stress disorder (PTSD) is a severe and disabling condition that may lead to functional impairment and reduced productivity. Psychological interventions have been shown to be effective in its management. The objective of this study was to assess the cost-effectiveness of a range of interventions for adults with PTSD.

Methods: A decision-analytic model was constructed to compare costs and quality-adjusted life-years (QALYs) of 10 interventions and no treatment for adults with PTSD, from the perspective of the National Health Service and personal social services in England. Effectiveness data were derived from a systematic review and network meta-analysis. Other model input parameters were based on published sources, supplemented by expert opinion.

Results: Eye movement desensitisation and reprocessing (EMDR) appeared to be the most cost-effective intervention for adults with PTSD (with a probability of 0.34 amongst the 11 evaluated options at a cost-effectiveness threshold of £20,000/QALY), followed by combined somatic/cognitive therapies, self-help with support, psychoeducation, selective serotonin reuptake inhibitors (SSRIs), trauma-focused cognitive behavioural therapy (TF-CBT), self-help without support, non-TF-CBT and combined TF-CBT/SSRIs. Counselling appeared to be less cost-effective than no treatment. TF-CBT had the largest evidence base.

Conclusions: A number of interventions appear to be cost-effective for the management of PTSD in adults. EMDR appears to be the most cost-effective amongst them. TF-CBT has the largest evidence base. There remains a need for well-conducted studies that examine the long-term clinical and cost-effectiveness of a range of treatments for adults with PTSD.
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http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0232245PLOS
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7192458PMC
July 2020

Psychological treatments for post-traumatic stress disorder in adults: a network meta-analysis.

Psychol Med 2020 03 17;50(4):542-555. Epub 2020 Feb 17.

Centre for Outcomes Research and Effectiveness, Research Department of Clinical, Educational & Health Psychology, University College London, 1-19 Torrington Place, LondonWC1E 7HB, UK.

Background: Post-traumatic stress disorder (PTSD) is a potentially chronic and disabling disorder affecting a significant minority of people exposed to trauma. Various psychological treatments have been shown to be effective, but their relative effects are not well established.

Methods: We undertook a systematic review and network meta-analyses of psychological interventions for adults with PTSD. Outcomes included PTSD symptom change scores post-treatment and at 1-4-month follow-up, and remission post-treatment.

Results: We included 90 trials, 6560 individuals and 22 interventions. Evidence was of moderate-to-low quality. Eye movement desensitisation and reprocessing (EMDR) [standardised mean difference (SMD) -2.07; 95% credible interval (CrI) -2.70 to -1.44], combined somatic/cognitive therapies (SMD -1.69; 95% CrI -2.66 to -0.73), trauma-focused cognitive behavioural therapy (TF-CBT) (SMD -1.46; 95% CrI -1.87 to -1.05) and self-help with support (SMD -1.46; 95% CrI -2.33 to -0.59) appeared to be most effective at reducing PTSD symptoms post-treatment v. waitlist, followed by non-TF-CBT, TF-CBT combined with a selective serotonin reuptake inhibitor (SSRI), SSRIs, self-help without support and counselling. EMDR and TF-CBT showed sustained effects at 1-4-month follow-up. EMDR, TF-CBT, self-help with support and counselling improved remission rates post-treatment. Results for other interventions were either inconclusive or based on limited evidence.

Conclusions: EMDR and TF-CBT appear to be most effective at reducing symptoms and improving remission rates in adults with PTSD. They are also effective at sustaining symptom improvements beyond treatment endpoint. Further research needs to explore the long-term comparative effectiveness of psychological therapies for adults with PTSD and also the impact of severity and complexity of PTSD on treatment outcomes.
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http://dx.doi.org/10.1017/S0033291720000070DOI Listing
March 2020

Early Parkinson's Disease Detection via Touchscreen Typing Analysis using Convolutional Neural Networks.

Annu Int Conf IEEE Eng Med Biol Soc 2019 Jul;2019:3535-3538

Parkinson's Disease (PD) is the second most common neurodegenerative disorder worldwide, causing both motor and non-motor symptoms. In the early stages, symptoms are mild and patients may ignore their existence. As a result, they do not undergo any related clinical examination; hence delaying their PD diagnosis. In an effort to remedy such delay, analysis of data passively captured from user's interaction with consumer technologies has been recently explored towards remote screening of early PD motor signs. In the current study, a smartphone-based method analyzing subjects' finger interaction with the smartphone screen is developed for the quantification of fine-motor skills decline in early PD using Convolutional Neural Networks. Experimental results from the analysis of keystroke typing in-the-clinic data from 18 early PD patients and 15 healthy controls have shown a classification performance of 0.89 Area Under the Curve (AUC) with 0.79/0.79 sensitivity/specificity, respectively. Evaluation of the generalization ability of the proposed approach was made by its application on typing data arising from a separate self-reported cohort of 27 PD patients' and 84 healthy controls' daily usage with their personal smartphones (data in-the-wild), achieving 0.79 AUC with 0.74/0.78 sensitivity/specificity, respectively. The results show the potentiality of the proposed approach to process keystroke dynamics arising from users' natural typing activity to detect PD, which contributes to the development of digital tools for remote pathological symptom screening.
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http://dx.doi.org/10.1109/EMBC.2019.8857211DOI Listing
July 2019

Infographic. How does exercise treatment compare with antihypertensive medications?

Br J Sports Med 2020 Jun 19;54(12):746-747. Epub 2019 Dec 19.

Department of Health Research and Policy, Stanford University School of Medicine, Stanford, California, USA.

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http://dx.doi.org/10.1136/bjsports-2019-101522DOI Listing
June 2020
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