Outcomes of digital biomarker-based interventions: protocol for a systematic review of systematic reviews (Preprint)

2021 ◽  
Author(s):  
Hossein Motahari-Nezhad ◽  
Márta Péntek ◽  
László Gulácsi ◽  
Zsombor Zrubka

BACKGROUND Digital biomarkers are defined as objective, quantifiable physiological and behavioral data that are collected and measured by means of digital devices such as portables, wearables, implantables or digestibles. For their widespread adoption in publicly financed healthcare systems, it is important to understand how their benefits translate into improved patient outcomes, which is essential for demonstrating their value. OBJECTIVE To assess the quality and strength of evidence of the impact of digital biomarkers on clinical outcomes compared to interventions without digital biomarkers, reported in systematic reviews. METHODS A comprehensive search for 2019-2020 will be conducted in the PubMed and the Cochrane Library using keywords related to digital biomarkers and a filter for systematic reviews. Original full-text English publications of systematic reviews comparing clinical outcomes of interventions with and without digital biomarkers via meta-analysis will be included. The AMSTAR-2 tool will be used to assess the methodological quality of reviews. To assess the quality of evidence, we will evaluate systematic reviews using the GRADE tool. To detect the possible presence of reporting bias, we will record whether the protocol of the systematic reviews was published before the start of the study. A qualitative summary of results by digital biomarker technology and outcome will be provided. RESULTS This protocol was submitted before data collection. The next steps in this review will be initiated after the protocol is accepted for publication. CONCLUSIONS Our study will provide a comprehensive summary of the highest level of evidence available on digital biomarker interventions. Our results will help identify clinical areas where the use of digital biomarkers leads to favorable clinical outcomes. In addition, our findings will highlight areas of evidence gaps where the clinical benefits of digital biomarkers have not yet been demonstrated.

2021 ◽  
pp. 000313482198903
Author(s):  
Mitsuru Ishizuka ◽  
Norisuke Shibuya ◽  
Kazutoshi Takagi ◽  
Hiroyuki Hachiya ◽  
Kazuma Tago ◽  
...  

Objective To explore the impact of appendectomy history on emergence of Parkinson’s disease (PD). Background Although there are several studies to investigate the relationship between appendectomy history and emergence of PD, the results are still controversial. Methods We performed a comprehensive electronic search of the literature (the Cochrane Library, PubMed, and the Web of Science) up to April 2020 to identify studies that had employed databases allowing comparison of emergence of PD between patients with and those without appendectomy history. To integrate the impact of appendectomy history on emergence of PD, a meta-analysis was performed using random-effects models to calculate the risk ratio (RR) and 95% confidence interval (CI) for the selected studies, and heterogeneity was analyzed using I2 statistics. Results Four studies involving a total of 6 080 710 patients were included in this meta-analysis. Among 1 470 613 patients with appendectomy history, 1845 (.13%) had emergences of PD during the observation period, whereas among 4 610 097 patients without appendectomy history, 6743 (.15%) had emergences of PD during the observation period. These results revealed that patients with appendectomy history and without appendectomy had almost the same emergence of PD (RR, 1.02; 95% CI, .87-1.20; P = .83; I2 = 87%). Conclusion This meta-analysis has demonstrated that there was no significant difference in emergence of PD between patients with and those without appendectomy history.


Author(s):  
Yusuke Handa ◽  
Kenya Okada ◽  
Hiroshi Takasaki

This systematic review and meta-analysis investigated whether the use of a lumbar roll reduced forward head posture (FHP) while sitting among individuals with or without musculoskeletal disorders. EMBASE, MEDLINE, and the Cochrane Library were systematically searched from their inception to August 2020. The quality of evidence for variables used in the meta-analysis was determined using the GRADE system. Five studies satisfied the criteria for data analysis. All studies included individuals without any spinal symptoms. Data from five studies on neck angle showed a statistically significant (p = 0.02) overall effect (standardized mean difference (SMD) = 0.77), indicating a lesser neck flexion angle while sitting with a lumbar roll than without it. Data from two studies on head angle showed a statistically significant (p = 0.04) overall effect (SMD = 0.47), indicating a lesser head extension angle while sitting with a lumbar roll than without it. In each meta-analysis, the quality of evidence was very low in the GRADE system. The use of a lumbar roll while sitting reduced FHP among individuals without spinal symptoms.


2015 ◽  
Vol 2015 ◽  
pp. 1-8 ◽  
Author(s):  
Rong-liang Dun ◽  
Min Yao ◽  
Long Yang ◽  
Xue-jun Cui ◽  
Jian-min Mao ◽  
...  

Objective. The objective of this study was to conduct a systematic review to assess the effectiveness and safety of traditional Chinese herb combined with surgery for male varicocele infertility compared to surgery.Methods. Randomized controlled trials (RCTs) data of traditional Chinese herbs combined with surgery for male varicocele fertility versus surgery were collected by searching the Cochrane Library, Embase, PubMed, and Chinese databases. The risk of bias was assessed using Cochrane Handbook. Study outcomes were presented as risk ratios (RRs) for dichotomous data.Results. Seventeen of 72 potentially relevant trials met the inclusion criteria. The methodological qualities of the RCTs were low. Compared with the surgery group, the traditional Chinese herb combined with surgery group had superiority in pregnancy rate at 3-month (RR=1.76, andP=0.008), 6-month (RR=1.58, andP=0.0005), and 2-year (RR=1.58, andP=0.0005) follow-ups. No RCT was found to describe the side effects.Conclusion. On considering the low methodological quality of RCTs, there was no enough evidence on traditional Chinese herb with surgery for male varicocele infertility, and more high-quality RCTs of large sample sizes are required.


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Israel Júnior Borges do Nascimento ◽  
Dónal P. O’Mathúna ◽  
Thilo Caspar von Groote ◽  
Hebatullah Mohamed Abdulazeem ◽  
Ishanka Weerasekara ◽  
...  

Abstract Background Navigating the rapidly growing body of scientific literature on the SARS-CoV-2 pandemic is challenging, and ongoing critical appraisal of this output is essential. We aimed to summarize and critically appraise systematic reviews of coronavirus disease (COVID-19) in humans that were available at the beginning of the pandemic. Methods Nine databases (Medline, EMBASE, Cochrane Library, CINAHL, Web of Sciences, PDQ-Evidence, WHO’s Global Research, LILACS, and Epistemonikos) were searched from December 1, 2019, to March 24, 2020. Systematic reviews analyzing primary studies of COVID-19 were included. Two authors independently undertook screening, selection, extraction (data on clinical symptoms, prevalence, pharmacological and non-pharmacological interventions, diagnostic test assessment, laboratory, and radiological findings), and quality assessment (AMSTAR 2). A meta-analysis was performed of the prevalence of clinical outcomes. Results Eighteen systematic reviews were included; one was empty (did not identify any relevant study). Using AMSTAR 2, confidence in the results of all 18 reviews was rated as “critically low”. Identified symptoms of COVID-19 were (range values of point estimates): fever (82–95%), cough with or without sputum (58–72%), dyspnea (26–59%), myalgia or muscle fatigue (29–51%), sore throat (10–13%), headache (8–12%) and gastrointestinal complaints (5–9%). Severe symptoms were more common in men. Elevated C-reactive protein and lactate dehydrogenase, and slightly elevated aspartate and alanine aminotransferase, were commonly described. Thrombocytopenia and elevated levels of procalcitonin and cardiac troponin I were associated with severe disease. A frequent finding on chest imaging was uni- or bilateral multilobar ground-glass opacity. A single review investigated the impact of medication (chloroquine) but found no verifiable clinical data. All-cause mortality ranged from 0.3 to 13.9%. Conclusions In this overview of systematic reviews, we analyzed evidence from the first 18 systematic reviews that were published after the emergence of COVID-19. However, confidence in the results of all reviews was “critically low”. Thus, systematic reviews that were published early on in the pandemic were of questionable usefulness. Even during public health emergencies, studies and systematic reviews should adhere to established methodological standards.


2021 ◽  
Author(s):  
Bandara EMIA ◽  
Kularathne WNI ◽  
K Brain ◽  
Weerasekara I

Abstract Primary dysmenorrhea (PD) is a common gynecological complaint among adolescents and adult women. Various pharmacological and alternative therapies such as therapeutic taping have been used as a treatment of PD. Although several studies have been conducted to evaluate the safety and efficacy of therapeutic taping in PD, these studies have not provided adequate level of evidence related to the safety and efficacy of therapeutic taping in PD. Hence, a systematic review and meta-analysis was performed to evaluate the safety and efficacy of therapeutic taping in PD. The following databases; Medline, Cochrane Library, Embase, PEDro, CINAHL and any other gray literature sources were searched for randomized controlled trials (RCTs) that used therapeutic taping to treat PD from inception to June 2021 with the language restricted to English. Independently screened articles by two reviewers were extracted according to the study objectives. A total of nine studies were included in the systematic review, involving 577 participants. Three studies were eligible for meta-analysis to find the pooled effect of taping on pain intensity. The review indicates that therapeutic taping is an effective measure in improving pain, anxiety and quality of life of women with PD. Meta-analysis conducted to compare the effect of elastic therapeutic taping (ETT) to sham taping showed that the ETT is an effective measure in improving pain among women with PD (MD = -3.12 (95% CI -5.64, -0.60); p=0.02; I2=95 %). The quality of the studies was assessed using the PEDro scale and the included RCTs indicated a fair to good level of quality. Our systematic review and meta-analysis demonstrated that therapeutic taping is an effective intervention for PD. However, RCTs with higher quality and larger sample sizes are necessary to verify the current results of the review.


2022 ◽  
Vol 10 (1) ◽  
Author(s):  
Fatima Safi ◽  
Anna M. Aniserowicz ◽  
Heather Colquhoun ◽  
Jill Stier ◽  
Behdin Nowrouzi-Kia

Abstract Background Eating disorders (ED) can reduce quality of life by limiting participation and performance in social and occupational roles, including paid or unpaid work. The association between ED pathologies and work participation and performance must be well understood to strengthen vocational rehabilitation programmes and prevent occupational disruptions in the ED population. The aims of this study are: (1) to examine the degree of association between ED pathologies and work participation and performance in 15-year-olds and older; (2) to highlight the specific ED symptoms that are most correlated with changes in work performance and participation; (3) to compile the most common metrics and assessments used to measure work participation and performance with ED. Methods Medline, Embase, CINAHL, Web of Science, PsycINFO, and Cochrane Library will be searched for observational and experimental studies that meet the following criteria: (1) a clinical sample of typical or atypical ED; (2) paid or unpaid employment or training; (3) an association between ED pathologies and work participation or performance. Unpublished data will also be examined. Title and abstract, and full-text screening will be conducted in duplicate. Risk of bias and quality of evidence assessments will be completed. A random-effect meta-analysis will be performed. Discussion This synthesis can clarify knowledge and gaps around the impact of ED on work functioning, thereby allowing better evaluation, improvements and development of current workplace assessments, interventions, and policies. Trial registration The registration number for this systematic review on PROSPERO is CRD42021255055.


Cartilage ◽  
2020 ◽  
pp. 194760352090659 ◽  
Author(s):  
Davide Previtali ◽  
Giulia Merli ◽  
Giorgio Di Laura Frattura ◽  
Christian Candrian ◽  
Stefano Zaffagnini ◽  
...  

Objectives To quantify the placebo effect of intraarticular injections for knee osteoarthritis in terms of pain, function, and objective outcomes. Factors influencing placebo effect were investigated. Design Meta-analysis of randomized controlled trials; Level of evidence, 2. PubMed, Web of Science, Cochrane Library, and grey literature databases were searched on January 8, 2020, using the string: (knee) AND (osteoarthritis OR OA) AND (injections OR intra-articular) AND (saline OR placebo). The following inclusion criteria were used: double-blind, randomized controlled trials on knee osteoarthritis, including a placebo arm on saline injections. The primary outcome was pain variation. Risk of bias was assessed using the RoB 2.0 tool, and quality of evidence was graded following the GRADE (Grading of Recommendations Assessment, Development and Evaluation) guidelines. Results Out of 2,363 records, 50 articles on 4,076 patients were included. The meta-analysis showed significant improvements up to the 6-month follow-up: Visual Analogue Scale (VAS)-pain −13.4 mean difference (MD) (95% confidence interval [CI]: −21.7/−5.1; P < 0.001), Western Ontario and McMaster Osteoarthritis Index (WOMAC)-pain −3.3 MD (95% CI: −3.9/−2.7; P < 0.001). Other significant improvements were WOMAC-stiffness −1.1 MD (95% CI: −1.6/−0.6; P < 0.001), WOMAC-function −10.1 MD (95% CI: −12.2/−8.0; P < 0.001), and Evaluator Global Assessment −21.4 MD (95% CI: −29.2/−13.6; P < 0.001). The responder rate was 52% (95% CI: 40% to 63%). Improvements were greater than the “minimal clinically important difference” for all outcomes (except 6-month VAS-pain). The level of evidence was moderate for almost all outcomes. Conclusions The placebo effect of knee injections is significant, with functional improvements lasting even longer than those reported for pain perception. The high, long-lasting, and heterogeneous effects on the scales commonly used in clinical trials further highlight that the impact of placebo should not be overlooked in the research on and management of knee osteoarthritis.


Author(s):  
Xiaohu Jin ◽  
Lin Wang ◽  
Shijie Liu ◽  
Lin Zhu ◽  
Paul Dinneen Loprinzi ◽  
...  

Purpose: To systematically evaluate the effects of mind-body exercises (Tai Chi, Yoga, and Health Qigong) on motor function (UPDRS, Timed-Up-and-Go, Balance), depressive symptoms, and quality of life (QoL) of Parkinson’s patients (PD). Methods: Through computer system search and manual retrieval, PubMed, Web of Science, The Cochrane Library, CNKI, Wanfang Database, and CQVIP were used. Articles were retrieved up to the published date of June 30, 2019. Following the Cochrane Collaboration System Evaluation Manual (version 5.1.0), two researchers independently evaluated the quality and bias risk of each article, including 22 evaluated articles. The Pedro quality score of 6 points or more was found for 86% (19/22) of these studies, of which 21 were randomized controlled trials with a total of 1199 subjects; and the trial intervention time ranged from 4 to 24 weeks. Interventions in the control group included no-intervention controls, placebo, waiting-lists, routine care, and non-sports controls. Meta-analysis was performed on the literature using RevMan 5.3 statistical software, and heterogeneity analysis was performed using Stata 14.0 software. Results: (1) Mind-body exercises significantly improved motor function in PD patients, including UPDRS (SMD = −0.61, p < 0.001), TUG (SMD = −1.47, p < 0.001) and balance function (SMD = 0.79, p < 0.001). (2) Mind-body exercises also had significant effects on depression (SMD = −1.61, p = 0.002) and QoL (SMD = 0.66, p < 0.001). (3) Among the indicators, UPDRS (I2 = 81%) and depression (I2 = 91%) had higher heterogeneity; according to the results of the separate combined effect sizes of TUG (I2 = 29%), Balance (I2 = 16%) and QoL (I2 = 35%), it shows that the heterogeneity is small; (4) After meta-regression analysis of the age limit and other possible confounding factors, further subgroup analysis showed that the reason for the heterogeneity of UPDRS motor function may be related to the sex of PD patients and severity of the disease; the outcome of depression was heterogeneous. The reason for this may be the use of specific drugs in the experiment and the duration of intervention in the trial. Conclusion: (1) Mind-body exercises were found to have significant improvements in motor function, depressive symptoms, and quality of life in patients with Parkinson’s disease, and can be used as an effective method for clinical exercise intervention in PD patients. (2) Future clinical intervention programs for PD patients need to fully consider specific factors such as gender, severity of disease, specific drug use, and intervention cycle to effectively control heterogeneity factors, so that the clinical exercise intervention program for PD patients is objective, scientific, and effective.


BMJ Open ◽  
2020 ◽  
Vol 10 (3) ◽  
pp. e035287
Author(s):  
Min Chen ◽  
Tai-Chun Tang ◽  
Tao-Hong He ◽  
Yong-Jun Du ◽  
Di Qin ◽  
...  

IntroductionThe prevalence of haemorrhoidal diseases was high in general population, and many treatments are proposed for the management of haemorrhoids. The treatments include conservative and surgical interventions; the credibility and strength of current evidence of their effectiveness are not comprehensively evaluated. We aim to evaluate the credibility of systematic reviews and meta-analyses that assess the effectiveness of the treatments for haemorrhoidal diseases through an umbrella review.Methods and analysisWe will search Ovid Medline, Embase, Cochrane library and Web of Science from inception to March 2020 without any language restriction. We will include meta-analyses that examine the effectiveness of treatments in the management of haemorrhoids. Two reviewers will independently screen the titles and abstracts of retrieved articles, and they will extract data from the included meta-analyses. For each meta-analysis, we will estimate the effect size of a treatment through the random-effect model and the fixed-effect model, and we will evaluate between-study heterogeneity (Cochrane’s Q and I2statistics) and small-study effect (Egger’s test); we will also estimate the evidence of excess significance bias. Evidence of each treatment will be graded according to prespecified criteria. Methodological quality of each meta-analysis will be evaluated by using Assessment of Multiple Systematic Reviews 2. The corrected cover area method will be used to assess the impact of overlap in reviews on the findings of the umbrella review.Ethics and disseminationWe will present the results of the umbrella review at conferences and publish the final report in a peer-reviewed journal. The umbrella review does not require ethical approval.PROSPERO registration numberCRD42019140702.


Medicines ◽  
2019 ◽  
Vol 6 (4) ◽  
pp. 112 ◽  
Author(s):  
Michela Iannone ◽  
Agata Janowska ◽  
Valentina Dini ◽  
Giulia Tonini ◽  
Teresa Oranges ◽  
...  

Background: The aims of this review are to analyze the current literature regarding the characteristics and pathophysiological mechanisms of itch in chronic wounds, to assess the impact on quality of life and delayed-healing, to focus on the best strategies of prevention and treatment, to highlight the importance of on-going research in order to fully understand the pathophysiology, and to improve the management of target therapies. Methods: A systematic literature review was performed using MEDLINE, PubMed, Embase, Scopus, ScienceDirect, and the Cochrane Library. We included a total of 11 articles written in English with relevant information on the pathophysiology of itch in chronic wounds and on management strategies. Results: Itch in chronic wounds was found to be correlated with xerosis, larger wound areas, necrotic tissue and amount of exudate, peripheral tissue edema, sclerosis, granulation tissue, contact dermatitis, and bacterial burden, as well as with lower quality of life. Conclusions: Although there are several aspecific pharmacological and non-pharmacological approaches, there appears to be no validated prevention or management strategy for itch in chronic wounds. Further studies are needed to clarify the association and pathophysiology of itch in chronic wounds, to evaluate the safety and efficacy of topical treatments on perilesional skin to reduce itch, to characterize multidimensional sensations of itch in chronic wounds, to identify specific cytokine and chemokine expressions that are correlated to a tailored-based approach, and to develop practical guidelines.


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