scholarly journals A Protocol for the Use of Case Reports/Studies and Case Series in Systematic Reviews for Clinical Toxicology

2021 ◽  
Vol 8 ◽  
Author(s):  
Aboubakari Nambiema ◽  
Grace Sembajwe ◽  
Juleen Lam ◽  
Tracey Woodruff ◽  
Daniele Mandrioli ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Human Subjects ◽  
Case Reports ◽  
Case Series ◽  
Risk Of Bias ◽  
Clinical Toxicology ◽  
New Drugs ◽  
Control Group ◽  
Quality Of Evidence

Introduction: Systematic reviews are routinely used to synthesize current science and evaluate the evidential strength and quality of resulting recommendations. For specific events, such as rare acute poisonings or preliminary reports of new drugs, we posit that case reports/studies and case series (human subjects research with no control group) may provide important evidence for systematic reviews. Our aim, therefore, is to present a protocol that uses rigorous selection criteria, to distinguish high quality case reports/studies and case series for inclusion in systematic reviews.Methods: This protocol will adapt the existing Navigation Guide methodology for specific inclusion of case studies. The usual procedure for systematic reviews will be followed. Case reports/studies and case series will be specified in the search strategy and included in separate sections. Data from these sources will be extracted and where possible, quantitatively synthesized. Criteria for integrating cases reports/studies and case series into the overall body of evidence are that these studies will need to be well-documented, scientifically rigorous, and follow ethical practices. The instructions and standards for evaluating risk of bias will be based on the Navigation Guide. The risk of bias, quality of evidence and the strength of recommendations will be assessed by two independent review teams that are blinded to each other.Conclusion: This is a protocol specified for systematic reviews that use case reports/studies and case series to evaluate the quality of evidence and strength of recommendations in disciplines like clinical toxicology, where case reports/studies are the norm.

scholarly journals The Effect of a Combined Gluten- and Casein-Free Diet on Children and Adolescents with Autism Spectrum Disorders: A Systematic Review and Meta-Analysis

Nutrients ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 470
Author(s):  
Amélie Keller ◽  
Marie Louise Rimestad ◽  
Jeanett Friis Rohde ◽  
Birgitte Holm Petersen ◽  
Christoffer Bruun Korfitsen ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Random Effect ◽  
Random Effect Model ◽  
Autism Spectrum ◽  
Risk Of Bias ◽  
Mean Difference ◽  
Cochrane Library ◽  
Measurement Tool ◽  
Quality Of Evidence

There has been a growing interest in the gastrointestinal system and its significance for autism spectrum disorder (ASD), including the significance of adopting a gluten-free and casein-free (GFCF) diet. The objective was to investigate beneficial and safety of a GFCF diet among children with a diagnosis of ASD. We performed a systematic literature search in Medline, Embase, Cinahl, and the Cochrane Library up to January 2020 for existing systematic reviews and individual randomized controlled trials (RCTs). Studies were included if they investigated a GFCF diet compared to a regular diet in children aged 3 to 17 years diagnosed with ASD, with or without comorbidities. The quality of the identified existing reviews was assessed using A Measurement Tool to Assess Systematic Reviews (AMSTAR). The risk of bias in RCTs was assessed using the Cochrane Risk of Bias Tool, and overall quality of evidence was evaluated using Grades of Recommendation, Assessment, Development, and Evaluation (GRADE). We identified six relevant RCTs, which included 143 participants. The results from a random effect model showed no effect of a GFCF diet on clinician-reported autism core symptoms (standardized mean difference (SMD) −0.31 (95% Cl. −0.89, 0.27)), parent-reported functional level (mean difference (MD) 0.61 (95% Cl −5.92, 7.14)) or behavioral difficulties (MD 0.80 (95% Cl −6.56, 10.16)). On the contrary, a GFCF diet might trigger gastrointestinal adverse effects (relative risk (RR) 2.33 (95% Cl 0.69, 7.90)). The quality of evidence ranged from low to very low due to serious risk of bias, serious risk of inconsistency, and serious risk of imprecision. Clinical implications of the present findings may be careful consideration of introducing a GFCF diet to children with ASD. However, the limitations of the current literature hinder the possibility of drawing any solid conclusion, and more high-quality RCTs are needed. The protocol is registered at the Danish Health Authority website.

scholarly journals Effectiveness and Safety of Acupuncture for Migraine: An Overview of Systematic Reviews

2020 ◽  
Vol 2020 ◽  
pp. 1-14 ◽  
Author(s):  
Yu-Xi Li ◽  
Xi-li Xiao ◽  
Dong-Ling Zhong ◽  
Liao-Jun Luo ◽  
Han Yang ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Western Medicine ◽  
Data Extraction ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Cochrane Library ◽  
Measurement Tool ◽  
High Quality ◽  
Quality Of Evidence

Background. Migraine is a common neurological disease, which burdens individuals and society all over the world. Acupuncture, an important method in Traditional Chinese Medicine, is widely used in clinical practice as a treatment for migraine. Several systematic reviews (SRs) have investigated the effectiveness and safety of acupuncture for migraine. Objective. To summarize and critically assess the quality of relevant SRs and present an objective and comprehensive evidence on the effectiveness and safety of acupuncture for migraine. Data Sources. MEDLINE, Embase, Cochrane Library, PROSPERO database, Chinese National Knowledge Infrastructure (CNKI), Chinese Biological Medicine (CBM), China Science and Technology Journal (SCTJ), and WanFang database (WF) were searched from inception to December 2019 and grey literatures were manually searched. Selection Criteria. SRs which meet the criteria were independently selected by 2 reviewers according to a predetermined protocol. Data Extraction. Characteristics of included SRs were independently extracted by 2 reviewers following a predefined data extraction form. Review Appraisal. The methodological quality, risk of bias, and reporting quality of included SRs were assessed, respectively, by a Measurement Tool to Assess Systematic Reviews (AMSTAR) 2, the Risk of Bias in Systematic reviews (ROBIS) tool, and the Preferred Reporting Item for Systematic Review and Meta-analysis-Acupuncture (PRISMA-A) statement. The quality of outcomes was evaluated by the Grading of Recommendations Assessment, Development, and Evaluation (GRADE). Results. A total of 15 SRs were included. All the SRs were published between 2011–2019. Based on AMSTAR 2, 14 out of 15 SRs were rated critically low quality and 1 was rated low quality. According to ROBIS tool, 9 SRs (60%) were low risk of bias. With the PRISMA-A checklist, we found 11 out of 15 SRs were found adequately reported over 70%. With the GRADE tool, we found high quality of evidence indicated that the effective rate of acupuncture was superior to western medicine in treatment of migraine. Besides, acupuncture reduced more headache days and the times of using painkiller and was more effective in reducing the frequency and degree of headache than western medicine and sham acupuncture. Limitations. There might be some missing information. The accuracy of the conclusions may be decreased reduced since we were unable to synthesis all the evidence. Conclusions. Based on high quality of evidence, we concluded that acupuncture may be an effective and safe therapy for migraine. However, the quality of SRs in acupuncture for migraine still needs more improvement.

scholarly journals A comparison between two recommendations to conduct and report systematic reviews on drug’s safety

2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Ana Penedones ◽  
Carlos Alves ◽  
Francisco Batel Marques
Keyword(s):  
Systematic Review ◽  
Systematic Reviews ◽  
Methodological Quality ◽  
Case Reports ◽  
Risk Of Bias ◽  
Drug Reactions ◽  
Post Marketing ◽  
Review Question ◽  
Marketing Data

Abstract Background Several recommendations are available to conduct and report a systematic review of adverse drug reactions. This study is aimed at identifying and comparing the methodologies of the two most commonly used recommendations to conduct and report systematic reviews on drug’s safety. Methods Two systematic reviews were conducted following the recommendations “Cochrane Handbook for Systematic Reviews of Interventions” and “Systematic Reviews’ Centre for Reviews and Dissemination guidance for undertaking reviews in healthcare.” The methods of each recommendation were characterized, and the results and the discussion of each systematic review were also evaluated. Results The methodologies of both recommendations are similar. The review question was structured. Both recommendations suggest to include pre- and post-marketing data. The recommended data sources differed and, consequently, the results of the systematic reviews (37 vs. 35 studies). Other aspects of search literature were identical. Different tools are suggested to evaluate the methodological quality of the included studies. For case reports, both recommendations only report some questions that may be helpful to assess risk of bias. The reporting of the results and discussion is also identical for both recommendations. Conclusions Few methodological differences were observed between the analyzed recommendations to conduct a systematic review on drug’s safety. Combining their methods into a single and recognized recommendation could be of great value.

scholarly journals Biologic Augmentation Reduces the Failure Rate of Meniscal Repair: A Systematic Review and Meta-analysis

2021 ◽  
Vol 9 (2) ◽  
pp. 232596712098162
Author(s):  
Stefano Zaffagnini ◽  
Alberto Poggi ◽  
Davide Reale ◽  
Luca Andriolo ◽  
David C. Flanigan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Failure Rate ◽  
Meta Analysis ◽  
Case Series ◽  
Meniscal Repair ◽  
Clinical Results ◽  
Risk Of Bias ◽  
Control Group ◽  
Augmentation Techniques

Background: Clinical results after isolated meniscal repair are not always satisfactory, with an overall failure rate of around 25%. To improve the success rate of meniscal repair, different biologic augmentation techniques have been introduced in clinical practice, but their real efficacy is still controversial. Purpose/Hypothesis: To evaluate the safety, clinical results, and failure rate of biologic augmentation techniques for meniscal repair. The hypothesis was that biologic augmentation would improve the results of meniscal repair. Study Design: Systematic review and meta-analysis of comparative studies. Methods: A systematic review of the literature was performed in March 2020 of 3 electronic databases (PubMed, Scopus, and the Cochrane Library) regarding meniscal repair combined with biologic augmentation techniques. Articles combining biologic augmentation with other surgical procedures besides meniscal suture were excluded. The quality of the included studies was assessed using a modified Coleman Methodology Score, and the risk of bias was evaluated using the ROBINS-I (Risk of Bias in Non-randomized Studies of Interventions) and the RoB 2.0 (Revised Tool for Risk of Bias in Randomized Trials) for nonrandomized and randomized controlled trials, respectively. Results: A total of 11 studies were included in the qualitative analysis: platelet-rich plasma (PRP) augmentation in 6 comparatives studies, fibrin clot augmentation in 2 case series, and mesenchymal stem cells augmentation in 2 case series and 1 case report. One severe adverse event of septic arthritis was reported for PRP 1 month after surgery. The quality of evidence evaluated with the modified Coleman Methodology Score was low overall. Five studies reporting on 286 patients (111 PRP augmentation, 175 control) were included in the quantitative synthesis. A significantly lower risk of failure was documented in the PRP augmentation group as compared with the control group: 9.9% (4.5%-19.1%) versus 25.7% (12.7%-38.7%) ( P < .0005). Conclusion: The literature on biologic meniscal augmentation is recent and scarce. Only a few comparative trials are available, all focusing on the potential of PRP. The meta-analysis documented that PRP is safe and useful in improving the survival rate, with a 9.9% rate of failure versus 25.7% for the control group. Further high-level studies are needed to confirm these findings and identify the most effective biologic augmentation strategy to improve the outcome of meniscal repair.

VP95 Getting the Best Of 3 Ways-Merging EUnetHTA GRADE And Cochrane Guides

2019 ◽  
Vol 35 (S1) ◽  
pp. 95-95
Author(s):  
Luciana Ballini ◽  
Giulio Formoso ◽  
Maria Chiara Bassi ◽  
Laura Bonvicini ◽  
Paolo Bottazzi ◽  
...  
Keyword(s):  
Systematic Reviews ◽  
Relative Effectiveness ◽  
Risk Of Bias ◽  
Plain Language ◽  
Quality Of Evidence ◽  
Significant Difference ◽  
Scope Project ◽  
Assess Quality ◽  
Scientific Abstract

IntroductionEuropean cooperation in Health Technology Assessment (HTA) requires joint assessments to be of high quality, providing findings transferable into national HTA report. To this aim, we piloted the combining of methodological guidance of EUnetHTA for Relative Effectiveness Assessment (REA), GRADE for selection/rating of outcomes and assessing quality of evidence, and Cochrane for Systematic Reviews, while carrying out a collaborative REA on Femtosecond Laser Assisted versus Standard Cataract Surgery.MethodsWhile developing the collaborative REA, we used the three organizations’ handbooks, templates and tools for Scope, Project Plan (PP), Summary of Findings, Effectiveness (EFF) and Safety (SAF) domains. We structured the PP according to the EUnetHTA template and added detailed methods on EFF and SAF systematic reviews, as per Cochrane Handbook. For the Scope we convened a multidisciplinary panel for selection and rating of importance of outcomes and clinically significant difference, using the GRADEpro platform. We developed the complete report adopting the EUnetHTA REA Core Model. We used Cochrane's tool Revman to assess risk of bias of included studies for each outcome, and to carry out metanalyses. We applied the GRADE approach to assess quality of evidence for each outcome and to express level of certainty in the estimates. We used the Cochrane handbook's guidance for structuring a scientific abstract and a Plain Language Summary to integrate the Summary of Findings.ResultsThe PP resulted in a detailed scientific and operational protocol, receiving extensive and constructive internal and external peer review. Reporting of EFF and SAF domains followed EUnetHTA Assessment Elements while keeping the order of stakeholders' rating of outcomes’ importance. Graphic representation of risk of bias for each outcome contributed to immediacy of the data quality assessment and transparency of the judgement on certainty. The scientific abstract and the Plain Language Summary, facilitated the external dissemination of results.ConclusionsMerging of the three most important methodological contributions in the field proved successful without altering the distinctive trait of the REA.

scholarly journals Quality of early evidence on the pathogenesis, diagnosis, prognosis and treatment of COVID-19

2020 ◽  
pp. bmjebm-2020-111499
Author(s):  
Sarah Yang ◽  
Allen Li ◽  
Ali Eshaghpour ◽  
Sofia Ivanisevic ◽  
Adrian Salopek ◽  
...  
Keyword(s):  
Study Design ◽  
Systematic Reviews ◽  
Case Reports ◽  
Case Series ◽  
Included Study ◽  
Expert Opinions ◽  
Newcastle Ottawa Scale ◽  
Initial Description ◽  
Number Of Publications

Since the initial description of the SARS-CoV-2 outbreak and its declaration as a worldwide pandemic, the number of publications on the novel virus has increased rapidly. We studied the trends and quality of evidence in early SARS-CoV-2 publications. A comprehensive search of MEDLINE and EMBASE was performed for papers published between 1 January 2020 and 21 April 2020. Two reviewers independently screened titles and abstracts and subsequently full texts for eligibility in this systematic review. The search yielded 2504 citations published between January and February 2020 or an unspecified date, 109 of which remained for extraction after screening. Data extracted included study design, year of publication, country of basis, journal of publication, impact factor of publishing journal, study sample size, number of citations and topic of investigation. Study design-specific critical appraisal tools were used to evaluate the scientific rigour of all included papers: the Joanna Briggs Institute checklist was used for case series, Scale for the Assessment of Narrative Review Articles scale for narrative reviews, Newcastle-Ottawa scale for cohort studies and AMSTAR 2 for systematic reviews. The overall quality of the literature was low-moderate. Of 541 papers that reported clinical characteristics, 295 were commentaries/expert opinions and 36 were case reports. There were no randomised clinical trials, 45 case series studies, 58 narrative reviews, 1 cohort study and 5 systematic reviews. We encourage clinicians to be attentive to these findings when utilising early SARS-CoV-2 evidence in their practices.

scholarly journals Laser Interstitial Thermal Therapy in Patients with Newly Diagnosed Glioblastoma: A Systematic Review

2021 ◽  
Vol 10 (2) ◽  
pp. 355
Author(s):  
Ilaria Viozzi ◽  
Alis Guberinic ◽  
Christiaan G. Overduin ◽  
Maroeska M. Rovers ◽  
Mark ter Laan
Keyword(s):  
Cost Effectiveness ◽  
Case Series ◽  
Risk Of Bias ◽  
Thermal Therapy ◽  
Newly Diagnosed ◽  
Quality Of Evidence ◽  
Laser Interstitial Thermal Therapy ◽  
Multicenter Randomized Controlled Trial ◽  
Newly Diagnosed Glioblastoma

Background: Laser interstitial thermal therapy (LITT) is a minimal invasive neurosurgical technique for the treatment of brain tumors. Results of LITT have been reported in a case series of patients with deep seated and/or recurrent glioblastoma or cerebral metastases. With this review we aim to summarize the currently available evidence regarding safety and effectiveness of LITT in patients with newly diagnosed glioblastoma (nGBM). Methods: A literature search was performed using electronic databases (PubMed and Embase). Papers were assessed for the methodological quality using the Risk Of Bias In Non- randomised Studies - of Interventions (ROBINS-I) tool, and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) was used to assess the quality of the evidence. Results: We identified 835 papers of which only 11 articles were eligible for our review. All papers suffered from serious or critical risk of bias, and the quality of evidence was graded as very low according to the GRADE criteria. None of the studies was randomized and reporting of confounders and other parameters was poor. Median overall survival (OS) ranged from 4.1 to 32 months and progression free survival (PFS) from 2 to 31 months. The mean complication rate was 33.7%. No quality of life or cost-effectiveness data were reported. Conclusions: Due to the low quality of the studies, it is not possible to draw firm conclusions regarding the (cost) effectiveness of LITT in patients with newly diagnosed glioblastoma. The low quality of evidence shows the need for a well-designed prospective multicenter randomized controlled trial.

scholarly journals Evaluating clinical characteristics studies produced early in the Covid-19 pandemic: A systematic review

PLoS ONE ◽  
2021 ◽  
Vol 16 (5) ◽  
pp. e0251250
Author(s):  
Lakshmi Manoharan ◽  
Jonathan W. S. Cattrall ◽  
Carlyn Harris ◽  
Katherine Newell ◽  
Blake Thomson ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Characteristics ◽  
Case Series ◽  
Cochrane Collaboration ◽  
Risk Of Bias ◽  
Quality Data ◽  
Control Group ◽  
Cross Sectional ◽  
Hospitalised Patients

Objectives Clinical characterisation studies have been essential in helping inform research, diagnosis and clinical management efforts, particularly early in a pandemic. This systematic review summarises the early literature on clinical characteristics of patients admitted to hospital, and evaluates the quality of evidence produced during the initial stages of the pandemic. Methods MEDLINE, EMBASE and Global Health databases were searched for studies published from January 1st 2020 to April 28th 2020. Studies which reported on at least 100 hospitalised patients with Covid-19 of any age were included. Data on clinical characteristics were independently extracted by two review authors. Study design specific critical appraisal tools were used to evaluate included studies: the Newcastle Ottawa scale for cohort and cross sectional studies, Joanna Briggs Institute checklist for case series and the Cochrane collaboration tool for assessing risk of bias in randomised trials. Results The search yielded 78 studies presenting data on 77,443 people. Most studies (82%) were conducted in China. No studies included patients from low- and middle-income countries. The overall quality of included studies was low to moderate, and the majority of studies did not include a control group. Fever and cough were the most commonly reported symptoms early in the pandemic. Laboratory and imaging findings were diverse with lymphocytopenia and ground glass opacities the most common findings respectively. Clinical data in children and vulnerable populations were limited. Conclusions The early Covid-19 literature had moderate to high risk of bias and presented several methodological issues. Early clinical characterisation studies should aim to include different at-risk populations, including patients in non-hospital settings. Pandemic preparedness requires collection tools to ensure observational studies are methodologically robust and will help produce high-quality data early on in the pandemic to guide clinical practice and public health policy. Review registration Available at https://osf.io/mpafn

scholarly journals Clinical Characteristics of Children with COVID-19: A Rapid Review and Meta-Analysis

2020 ◽  
Author(s):  
Zijun Wang ◽  
Qi Zhou ◽  
Chenglin Wang ◽  
Qianling Shi ◽  
Shuya Lu ◽  
...  
Keyword(s):  
Lymphocyte Count ◽  
Clinical Characteristics ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Risk Of Bias ◽  
Rapid Review ◽  
Random Effects Model ◽  
Normal Range

AbstractBackgroundMost guidelines on COVID-19 published so far include recommendations for patients regardless of age. Clinicians need a more accurate understanding of the clinical characteristics of children with COVID-19.MethodsWe searched studies reporting clinical characteristics in children with COVID-19 published until March 31, 2020. We screened the literature, extracted the data and evaluated the risk of bias and quality of evidence of the included studies. We combined some of the outcomes (symptoms) in a single-arm meta-analysis using a random-effects model.ResultsOur search retrieved 49 studies, including 25 case reports, 23 case series and one cohort study, with a total of 1667 patients. Our meta-analysis showed that most children with COVID-19 have mild symptoms. Eighty-three percent of the children were within family clusters of cases, and 19% had no symptoms. At least 7% with digestive symptoms. The main symptoms of children were fever (48%, 95% confidence interval [CI]: 39%, 56%) and cough (39%, 95% CI: 30%, 48%). The lymphocyte count was below normal level in only 15% [95% CI: 8%, 22%] of children which is different from adult patients. 66% [95% CI: 55%, 77%] of children had abnormal findings in CT imaging.ConclusionsMost children with COVID-19 have only mild symptoms, and many children are asymptomatic. Fever and cough are the most common symptoms in children. Vomiting and diarrhea were not common in children. The lymphocyte count is usually within the normal range in children.

Effectiveness of mobile applications on healthy lifestyles aimed at diabetic patients: review of systematic reviews. (Preprint)

2019 ◽  
Author(s):  
Francisco Jesús Represas Carrera Sr ◽  
Ángel Alfredo Martínez Ques Sr ◽  
Ana Clavería Fontán Sr
Keyword(s):  
Quality Of Life ◽  
Diabetes Mellitus ◽  
Systematic Reviews ◽  
Mobile Applications ◽  
Control Group ◽  
Diabetic Patients ◽  
Healthy Lifestyles ◽  
Major Public Health Problem

BACKGROUND Diabetes mellitus is currently a major public health problem worldwide. It is traditionally approached in a clinical inpatient relationship between the patient and the healthcare professional. However, the rise of new technologies, particularly mobile applications, is revolutionizing the traditional healthcare model through the introduction of telehealthcare. OBJECTIVE (1) To assess the effects of mobile applications for improving healthy lifestyles on the quality of life and metabolic control of diabetes mellitus in adult patients. (2) To describe the characteristics of the mobile applications used, identify the healthy lifestyles they target, and describe any adverse effects their use may have. METHODS Review of systematic reviews and meta-analysis, following the guidelines of the Cochrane Collaboration and the Joanna Briggs Institute. We included studies that used any mobile application aimed at helping patients improve self-management of diabetes mellitus by focusing on healthy lifestyles. Studies needed to include a control group receiving regular care without the use of mobile devices. In May 2018, a search was conducted in Medline, Embase, Cochrane, LILACS, PsychINFO, Cinahl and Science Direct, updated in May 2019. The methodological quality of the studies was assessed using the Amstar-2 tool. RESULTS Seven systematic reviews of 798 articles were initially selected for analysis. The interventions had a duration of between 1 and 12 months. Mobile applications focused singly or simultaneously on different lifestyles aspects (diet, physical exercise, motivation, blood glucose levels, etc.). There are significant changes in HbA1c values, body weight and BMI, although in others, such as lipid profile, quality of life, or blood pressure, there is no clear improvement. CONCLUSIONS There is clear evidence that the use of mobile applications improves glycemic control in diabetic patients in the short term. There is a lack of evidence in its long-term benefits. It is thus necessary to carry out further studies to learn about the long-term effectiveness of mobile applications aimed at promoting the healthy lifestyles of diabetic patients. CLINICALTRIAL PROSPERO Register: CRD42019133685

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