Recommendations for defining and reporting adherence measured by Biometric Monitoring Technologies (BioMeTs): A systematic review (Preprint)

2021 ◽  
Author(s):  
Iredia M Olaye ◽  
Mia P Belovsky ◽  
Lauren Bataille ◽  
Royce Cheng ◽  
Ali Ciger ◽  
...  
Keyword(s):  
Systematic Review ◽  
Data Collection ◽  
Clinical Trial Data ◽  
Continuous Variable ◽  
Digital Data ◽  
Categorical Variable ◽  
Eligibility Criteria ◽  
Validation Data ◽  
Adherence Data ◽  
Monitoring Technologies

BACKGROUND Sub-optimal adherence to data collection procedures and/or a study intervention is often the cause of a failed clinical trial. Data from biometric monitoring technologies (BioMeTs) can measure adherence to both digital therapeutics and digital data collection procedures, thereby providing the opportunity to identify the determinants of adherence and thereafter, methods to maximize adherence. OBJECTIVE Our goal was to describe the methods and definitions by which adherence has been captured and reported using BioMeTs in recent years. Identifying key gaps allowed us to make recommendations regarding minimum reporting requirements and consistency of definitions for BioMeT-based adherence data. METHODS We conducted a systematic review of studies published between 2014 and 2019 that deployed a BioMeT outside of the clinical/lab setting for which a quantitative, non-surrogate, sensor-based measurement of adherence was reported. After systematically screening manuscripts for eligibility, we extracted details regarding study design, participants, the BioMeT/s used, and the definition and units of adherence. Primary definitions of adherence were categorized as a continuous variable based on duration (highest resolution), a continuous variable based on the number of measurements completed, or a categorical variable (lowest resolution). RESULTS Our PubMed search terms identified 940 manuscripts; 100 met our eligibility criteria, which contained descriptions of 110 BioMeTs. We identified 37 unique definitions of adherence reported for 110 BioMeTs, and observed that the uniformity of adherence definitions was associated with the resolution of the data reported. When adherence was reported as a continuous time-based variable, the same definition of adherence was adopted for 92% of the tools; however, when adherence data were simplified to a categorical variable, we observed 25 unique definitions of adherence reported for 37 tools. CONCLUSIONS We recommend that: A) quantitative, non-surrogate, sensor-based, adherence data be reported for all BioMeTs when feasible; B) a clear description of the sensor/s used to capture adherence data, the algorithm/s that convert sample-level measurements to a metric of adherence, and the analytical validation data demonstrating that BioMeT-generated adherence is an accurate and reliable measurement of actual usage, be provided when available; and C) primary adherence data be reported as a continuous variable followed by categorical definitions if needed, and that the categories adopted are supported by clinical validation data and/or consistent with previous reports.

scholarly journals Convalescent Plasma in the Treatment of Severe COVID-19: A Systematic Review and Meta-Analysis

2020 ◽  
Author(s):  
Xuanguo ZHANG ◽  
Li XI ◽  
Fang PANG ◽  
Yan DU ◽  
Qiuzhen YUAN ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Reactions ◽  
Clinical Evidence ◽  
Meta Analysis ◽  
Clinical Trial Data ◽  
Incidence Rates ◽  
Knowledge Network ◽  
Eligibility Criteria ◽  
Plasma Therapy ◽  
Systematic Analysis

Background: COVID-19 is a public health emergency of international concern. Its incidence rates and mortality are very high; however, so far, an effective drug treatment remains unknown. Based on the role of convalescent plasma therapy in previously identified viral pneumonias, patients with severe COVID-19 have been given this therapy. This systematic review and meta-analysis aimed to summarize the clinical evidence regarding the efficacy and safety of convalescent plasma therapy in the treatment of severe COVID-19. Methods: PubMed, Embase, Ovid, China Knowledge Network, China Biomedical, VIP Chinese Sci-tech Journal, Wanfang Database, and the International Clinical Trials Registry Platform were searched up to 21 June 2020, to identify clinical studies and registered trials on the use of convalescent plasma in the treatment of critically ill patients with COVID-19. Stata 13.0 was used to perform Meta-analysis. All records were screened as per the protocol eligibility criteria. Results: Nineteen clinical reports regarding convalescent plasma in the treatment of severe COVID-19 were included. Through systematic analysis, convalescent plasma was found to yield some efficacy on severe COVID-19 and had almost no obvious adverse reactions. Conclusion: Convalescent plasma therapy seems to yield some efficacy among patients with severe COVID-19 and almost no obvious adverse reactions were found. However, at present, the clinical evidence is insufficient, and there is an urgent need for support from high-quality clinical trial data.  

Impact of Different Methods for Describing the Extent of Prior Antibiotic Exposure on the Association Between Antibiotic Use and Antibiotic-Resistant Infection

2007 ◽  
Vol 28 (6) ◽  
pp. 647-654 ◽  
Author(s):  
Emily P. Hyle ◽  
Warren B. Bilker ◽  
Leanne B. Gasink ◽  
Ebbing Lautenbach
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Antibiotic Use ◽  
Continuous Variable ◽  
Antibiotic Exposure ◽  
Categorical Variable ◽  
Antibiotic Resistant ◽  
E Coli ◽  
Multivariable Models ◽  
The Impact

Objective.Many studies have investigated the association between prior antibiotic use and antibiotic resistance. However, methods used in past studies to describe the extent of prior antibiotic use (eg, use of the 2 categories exposure versus no exposure and measurement of duration of exposure) have not been reviewed. The impact of the use of different methods for quantifying the use of antibiotics is unknown. The objectives of this study were to characterize past approaches to describing the extent of antibiotic use and to identify the impact of the use of different methods on associations between use of specific antibiotics and infection with an antibiotic-resistant-organism.Methods.We conducted a systematic review of studies that investigated risk factors for extended-spectrum β-lactamase (ESBL)-producing Escherichia coli and Klebsiella species to identify variability in past approaches to describing the extent of antibiotic use. We then reanalyzed a data set from a prior study of risk factors for infection with ESBL-producing E. coli and Klebsiella species. We developed 2 separate multivariable models: 1 in which prior antibiotic use was described as a categorical variable (eg, exposure or no exposure) and 1 in which antibiotic use was described as a continuous variable (eg, measured in antibiotic-days). These models were compared qualitatively.Setting.Large academic medical center.Results.The 25 articles included in the systematic review revealed a variety of methods used to describe the extent of prior antibiotic exposure. Only 1 study justified its approach. Results from the 2 multivariable models that used different methodologic approaches differed substantially. Specifically, use of third-generation cephalosporins was a risk factor for infection with ESBL-producing E. coli and Klebsiella species when antibiotic use was described as a continuous variable but not when antibiotic use was described as a categorical variable.Conclusions.There has been no consistent method for assessing the extent of prior antibiotic exposure. The use of different methods may substantially alter the identified antimicrobial risk factors, which has important implications for the resultant interventions regarding antimicrobial use.

Status of human toxocariasis, a neglected parasitic zoonosis in Iran: a systematic review from past to current

2020 ◽  
Vol 50 (4) ◽  
pp. 285-291 ◽  
Author(s):  
Reza Shafiei ◽  
Mohammad T Rahimi ◽  
Reza Zolfaghari Emameh ◽  
Mehdi Mirzaei ◽  
Gregorio Perez-Cordon ◽  
...  
Keyword(s):  
Systematic Review ◽  
Data Collection ◽  
Confidence Interval ◽  
Google Scholar ◽  
Seroprevalence Rate ◽  
Eligibility Criteria ◽  
The Past ◽  
Q Statistic ◽  
Toxocara Species ◽  
Epidemiological Information

Although human toxocariasis can lead to serious complications including neurological, ocular and visceral complications, there is a lack of comprehensive epidemiological information about the seroprevalence of Toxocara species in humans. In the present study, we analysed and reviewed the overall seroprevalence of human toxocariasis in Iran. The data collection was systematically undertaken on published articles using the PubMed, Google Scholar, ScienceDirect and Scopus databases. A total of 27 studies from the past two decades reporting seroprevalence of human toxocariasis met our eligibility criteria. The pooled proportion of Toxocara infection was estimated as 6.58% (95% confidence interval = 3.98–9.77). A wide variation between different studies was observed (Q statistic = 799.37, df = 26, P < 0.0001, and I2 = 96.7%). The seroprevalence rate of toxocariasis in the Iranian population is relatively high; contamination of the environment by eggs from the host as well as from household dogs and cats should be blamed.

Chasing the Anchor: A Systematic Review and Meta-analysis of Perceptual Anchoring Deficits in Developmental Dyslexia

2020 ◽  
Author(s):  
Kurt D Shulver ◽  
Nicholas A Badcock
Keyword(s):  
Systematic Review ◽  
Reading Ability ◽  
English Language ◽  
Prediction Interval ◽  
Meta Analysis ◽  
Visual Assessment ◽  
Individual Performance ◽  
Future Research ◽  
Significant Heterogeneity ◽  
Eligibility Criteria

We report the results of a systematic review and meta-analysis investigating the relationship between perceptual anchoring and dyslexia. Our goal was to assess the direction and degree of effect between perceptual anchoring and reading ability in typical and atypical (dyslexic) readers. We performed a literature search of experiments explicitly assessing perceptual anchoring and reading ability using PsycInfo (Ovid, 1860 to 2020), MEDLINE (Ovid, 1860 to 2019), EMBASE (Ovid, 1883 to 2019), and PubMed for all available years up to June (2020). Our eligibility criteria consisted of English-language articles and, at minimum, one experimental group identified as dyslexic - either by reading assessment at the time, or by previous diagnosis. We assessed for risk of bias using an adapted version of the Newcastle-Ottawa scale. Six studies were included in this review, but only five (n = 280 participants) were included in the meta-analysis (we were unable to access the necessary data for one study).The overall effect was negative, large and statistically significant; g = -0.87, 95% CI [-1.47, 0.27]: a negative effect size indicating less perceptual anchoring in dyslexic versus non-dyslexic groups. Visual assessment of funnel plot and Egger’s test suggest minimal bias but with significant heterogeneity; Q (4) = 9.70, PI (prediction interval) [-2.32, -0.58]. The primary limitation of the current review is the small number of included studies. We discuss methodological limitations, such as limited power, and how future research may redress these concerns. The variability of effect sizes appears consistent with the inherent variability within subtypes of dyslexia. This level of dispersion seems indicative of the how we define cut-off thresholds between typical reading and dyslexia populations, but also the methodological tools we use to investigate individual performance.

Covid-19 and Autoimmune Diseases: A Systematic Review of Reported Cases

2020 ◽  
Vol 16 ◽  
Author(s):  
Mariam Ahmed Saad ◽  
Mostafa Alfishawy ◽  
Mahmoud Nassar ◽  
Mahmoud Mohamed ◽  
Ignatius N Esene ◽  
...  
Keyword(s):  
Systematic Review ◽  
Autoimmune Disease ◽  
Kawasaki Disease ◽  
Autoimmune Diseases ◽  
English Language ◽  
Clinical Evidence ◽  
Eligibility Criteria ◽  
Thrombocytopenic Purpura ◽  
Pubmed Database ◽  
Viral Illness

Introduction: Over 4.9 million cases of Coronavirus disease 2019 (COVID-19) have been confirmed since the worldwide pandemic began. Since the emergence of COVID-19, a number of confirmed cases reported autoimmune manifestations. Herein, we reviewed the reported COVID-19 cases with associated autoimmune manifestations. Methods: We searched PubMed database using all available keyword for COVID-19. All related studies between January 1st, 2020 to May 22nd, 2020 were reviewed. Only studies published in English language were considered. Articles were screened based on titles and abstract. All reports of confirmed COVID-19 patients who have associated clinical evidence of autoimmune disease were selected. Results: Among 10006 articles, searches yielded, Thirty-two relevant articles for full-text assessment. Twenty studies meet the eligibility criteria. The twenty eligible articles reported 33 cases of confirmed COVID-19 diagnosis who developed an autoimmune disease after the onset of covid-19 symptoms. Ages of patients varied from a 6 months old infant to 89 years old female (Mean=53.9 years of 28 cases); five cases had no information regarding their age. The time between symptoms of viral illness and onset of autoimmune symptoms ranged from 2 days to 33 days (Mean of the 33 cases=9.8 days). Autoimmune diseases were one case of subacute thyroiditis (3%), two cases of Kawasaki Disease (6.1%), three cases of coagulopathy and antiphospholipid syndrome (9.1%), three cases of immune thrombocytopenic purpura (9.1%), eight cases of autoimmune hemolytic anemia (24.2%), and sixteen cases of Guillain–Barré syndrome (48.5%). Conclusions: COVID-19 has been implicated in the development in a range of autoimmune diseases which may shed a light on the association between autoimmune diseases and infections.

The Impact of Environmental Stress on Cognitive Performance: A Systematic Review

2019 ◽  
Vol 61 (8) ◽  
pp. 1205-1246 ◽  
Author(s):  
Kristy Martin ◽  
Emily McLeod ◽  
Julien Périard ◽  
Ben Rattray ◽  
Richard Keegan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Environmental Stress ◽  
Task Performance ◽  
Sea Level ◽  
Cognitive Performance ◽  
Cognitive Task ◽  
Individual Characteristics ◽  
Eligibility Criteria ◽  
Healthy Human ◽  
The Impact

Objective: In this review, we detail the impact of environmental stress on cognitive and military task performance and highlight any individual characteristics or interventions which may mitigate any negative effect. Background: Military personnel are often deployed in regions markedly different from their own, experiencing hot days, cold nights, and trips both above and below sea level. In spite of these stressors, high-level cognitive and operational performance must be maintained. Method: A systematic review of the electronic databases Medline (PubMed), EMBASE (Scopus), PsycINFO, and Web of Science was conducted from inception up to September 2018. Eligibility criteria included a healthy human cohort, an outcome of cognition or military task performance and assessment of an environmental condition. Results: The search returned 113,850 records, of which 124 were included in the systematic review. Thirty-one studies examined the impact of heat stress on cognition; 20 of cold stress; 59 of altitude exposure; and 18 of being below sea level. Conclusion: The severity and duration of exposure to the environmental stressor affects the degree to which cognitive performance can be impaired, as does the complexity of the cognitive task and the skill or familiarity of the individual performing the task. Application: Strategies to improve cognitive performance in extreme environmental conditions should focus on reducing the magnitude of the physiological and perceptual disturbance caused by the stressor. Strategies may include acclimatization and habituation, being well skilled on the task, and reducing sensations of thermal stress with approaches such as head and neck cooling.

scholarly journals Biomarkers predictive of treatment response in psoriasis and psoriatic arthritis: a systematic review

2021 ◽  
Vol 13 ◽  
pp. 1759720X2110140
Author(s):  
Conor Magee ◽  
Hannah Jethwa ◽  
Oliver M. FitzGerald ◽  
Deepak R. Jadon
Keyword(s):  
Systematic Review ◽  
Psoriatic Arthritis ◽  
Treatment Response ◽  
Unmet Need ◽  
Response To Treatment ◽  
Cochrane Library ◽  
Original Research ◽  
Eligibility Criteria ◽  
Psoriatic Disease ◽  
Subsequent Response

Aims: The ability to predict response to treatment remains a key unmet need in psoriatic disease. We conducted a systematic review of studies relating to biomarkers associated with response to treatment in either psoriasis vulgaris (PsV) or psoriatic arthritis (PsA). Methods: A search was conducted in PubMed, Embase and the Cochrane library from their inception to 2 September 2020, and conference proceedings from four major rheumatology conferences. Original research articles studying pre-treatment biomarker levels associated with subsequent response to pharmacologic treatment in either PsV or PsA were included. Results: A total of 765 articles were retrieved and after review, 44 articles (22 relating to PsV and 22 to PsA) met the systematic review’s eligibility criteria. One study examined the response to methotrexate, one the response to tofacitinib and all the other studies to biologic disease-modifying antirheumatic drugs (DMARDs). Whilst several studies examined the HLA-C*06 allele in PsV, the results were conflicting. Interleukin (IL)-12 serum levels and polymorphisms in the IL-12B gene show promise as biomarkers of treatment response in PsV. Most, but not all, studies found that higher baseline levels of C-reactive protein (CRP) were associated with a better clinical response to treatment in patients with PsA. Conclusion: Several studies have identified biomarkers associated with subsequent response to treatment in psoriatic disease. However, due to the different types of biomarkers, treatments and outcome measures used, firm conclusions cannot be drawn. Further validation is needed before any of these biomarkers translate to clinical practice.

scholarly journals A systematic review of the factors associated with the course of borderline personality disorder symptoms in adolescence

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Gabriele Skabeikyte ◽  
Rasa Barkauskiene
Keyword(s):  
Risk Factors ◽  
Systematic Review ◽  
Borderline Personality Disorder ◽  
Personality Disorder ◽  
Strong Support ◽  
Borderline Personality ◽  
Developmental Pathways ◽  
Eligibility Criteria ◽  
Factors Associated ◽  
Prospective Longitudinal

Abstract Background Research on personality pathology in adolescence has accelerated during the last decade. Among all of the personality disorders, there is strong support for the validity of borderline personality disorder (BPD) diagnosis in adolescence with comparable stability as seen in adulthood. Researchers have put much effort in the analysis of the developmental pathways and etiology of the disorder and currently are relocating their attention to the identification of the possible risk factors associated with the course of BPD symptoms during adolescence. The risk profile provided in previous systematic reviews did not address the possible development and course of BPD features across time. Having this in mind, the purpose of this systematic review is to identify the factors that are associated with the course of BPD symptoms during adolescence. Methods Electronic databases were systematically searched for prospective longitudinal studies with at least two assessments of BPD as an outcome of the examined risk factors. A total number of 14 articles from the period of almost 40 years were identified as fitting the eligibility criteria. Conclusions Factors associated with the course of BPD symptoms include childhood temperament, comorbid psychopathology, and current interpersonal experiences. The current review adds up to the knowledge base about factors that are associated with the persistence or worsening of BPD symptoms in adolescence, describing the factors congruent to different developmental periods.

scholarly journals Real-World Outcomes of Ivacaftor Treatment in People with Cystic Fibrosis: A Systematic Review

2021 ◽  
Vol 10 (7) ◽  
pp. 1527
Author(s):  
Jamie Duckers ◽  
Beth Lesher ◽  
Teja Thorat ◽  
Eleanor Lucas ◽  
Lisa J. McGarry ◽  
...  
Keyword(s):  
Systematic Review ◽  
Cystic Fibrosis ◽  
Real World ◽  
Safety Profile ◽  
Clinical Trial Data ◽  
Patient Characteristics ◽  
Healthcare Resource Utilization ◽  
Patient Reported ◽  
Clinical Benefits

Cystic fibrosis (CF) is a rare, progressive, multi-organ genetic disease. Ivacaftor, a small-molecule CF transmembrane conductance regulator modulator, was the first medication to treat the underlying cause of CF. Since its approval, real-world clinical experience on the use of ivacaftor has been documented in large registries and smaller studies. Here, we systematically review data from real-world observational studies of ivacaftor treatment in people with CF (pwCF). Searches of MEDLINE and Embase identified 368 publications reporting real-world studies that enrolled six or more pwCF treated with ivacaftor published between January 2012 and September 2019. Overall, 75 publications providing data from 57 unique studies met inclusion criteria and were reviewed. Studies reporting within-group change for pwCF treated with ivacaftor consistently showed improvements in lung function, nutritional parameters, and patient-reported respiratory and sino-nasal symptoms. Benefits were evident as early as 1 month following ivacaftor initiation and were sustained over long-term follow-up. Decreases in pulmonary exacerbations, Pseudomonas aeruginosa prevalence, and healthcare resource utilization also were reported for up to 66 months following ivacaftor initiation. In studies comparing ivacaftor treatment to modulator untreated comparator groups, clinical benefits similarly were reported as were decreases in mortality, organ-transplantation, and CF-related complications. The safety profile of ivacaftor observed in these real-world studies was consistent with the well-established safety profile based on clinical trial data. Our systematic review of real-world studies shows ivacaftor treatment in pwCF results in highly consistent and sustained clinical benefit in both pulmonary and non-pulmonary outcomes across various geographies, study designs, patient characteristics, and follow-up durations, confirming and expanding upon evidence from clinical trials.

scholarly journals Injuries and frequent use of emergency department services: a systematic review

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e040272
Author(s):  
Catherine Laferté ◽  
Andréa Dépelteau ◽  
Catherine Hudon
Keyword(s):  
Systematic Review ◽  
Emergency Department ◽  
Cohort Studies ◽  
Eligibility Criteria ◽  
Geriatric Population ◽  
Physical Injuries ◽  
Frequent Use ◽  
Different Types ◽  
Ed Visits ◽  
Return Visits

ObjectiveTo review all studies having examined the association between patients with physical injuries and frequent emergency department (ED) attendance or return visits.DesignSystematic review.Data sourceMedline, Cumulative Index to Nursing and Allied Health Literature (CINAHL) and PsycINFO databases were searched up to and including July 2019.Eligibility criteriaEnglish and French language publications reporting on frequent use of ED services (frequent attendance and return visits), evaluating injured patients and using regression analysis.Data extraction and synthesisTwo independent reviewers screened the search results, and assessed methodological quality using the Joanna Briggs Institute tool for prevalence studies. Results were collated and summarised using a narrative synthesis. A sensitivity analysis was performed to evaluate the repercussions of removing a study that did not meet the quality criteria.ResultsOf the 2184 studies yielded by this search, 1957 remained after the removal of duplicates. Seventy-eight studies underwent full-text screening leaving nine that met the eligibility criteria and were included in this study: five retrospective cohort studies; two prospective cohort studies; one cross-sectional study; and one case-control study. Different types of injuries were represented, including fractures, trauma and physical injuries related to falls, domestic violence or accidents. Sample sizes ranged from 200 to 1 259 809. Six studies included a geriatric population while three addressed a younger population. Of the four studies evaluating the relationship between injuries and frequent ED use, three reported an association. Additionally, of the five studies in which the dependent variable was return ED visits, three articles identified a positive association with injuries.ConclusionsPhysical injuries appear to be associated with frequent use of ED services (frequent ED attendance as well as return ED visits). Further research into factors including relevant youth-related covariates such as substance abuse and different types of traumas should be undertaken to bridge the gap in understanding this association.

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