scholarly journals The role of pragmatism in explaining heterogeneity in meta-analyses of randomised trials: a protocol for a cross-sectional methodological review

BMJ Open ◽  
2017 ◽  
Vol 7 (9) ◽  
pp. e017887 ◽  
Author(s):  
Theresa Aves ◽  
Katherine S Allan ◽  
Daeria Lawson ◽  
Robby Nieuwlaat ◽  
Joseph Beyene ◽  
...  

IntroductionThere has been increasing interest in pragmatic trials methodology. As a result, tools such as the Pragmatic-Explanatory Continuum Indicator Summary-2 (PRECIS-2) are being used prospectively to help researchers design randomised controlled trials (RCTs) within the pragmatic-explanatory continuum. There may be value in applying the PRECIS-2 tool retrospectively in a systematic review setting as it could provide important information about how to pool data based on the degree of pragmatism.ObjectivesTo investigate the role of pragmatism as a source of heterogeneity in systematic reviews by (1) identifying systematic reviews with meta-analyses of RCTs that have moderate to high heterogeneity, (2) applying PRECIS-2 to RCTs of systematic reviews, (3) evaluating the inter-rater reliability of PRECIS-2, (4) determining how much of this heterogeneity may be explained by pragmatism.MethodsA cross-sectional methodological review will be conducted on systematic reviews of RCTs published in the Cochrane Library from 1 January 2014 to 1 January 2017. Included systematic reviews will have a minimum of 10 RCTs in the meta-analysis of the primary outcome and moderate to substantial heterogeneity (I2≥50%). Of the eligible systematic reviews, a random selection of 10 will be included for quantitative evaluation. In each systematic review, RCTs will be scored using the PRECIS-2 tool, in duplicate. Agreement between raters will be measured using the intraclass correlation coefficient. Subgroup analyses and meta-regression will be used to evaluate how much variability in the primary outcome may be due to pragmatism.DisseminationThis review will be among the first to evaluate the PRECIS-2 tool in a systematic review setting. Results from this research will provide inter-rater reliability information about PRECIS-2 and may be used to provide methodological guidance when dealing with pragmatism in systematic reviews and subgroup considerations. On completion, this review will be submitted to a peer-reviewed journal for publication.

2021 ◽  
Vol 9 (2) ◽  
pp. e002528
Author(s):  
Ally McIllhatton ◽  
Sean Lanting ◽  
David Lambkin ◽  
Lucy Leigh ◽  
Sarah Casey ◽  
...  

The objective is to determine, by systematic review, the reliability of testing methods for diagnosis of diabetes-related peripheral neuropathy (DPN) as recommended by the most recent guidelines from the International Diabetes Foundation, International Working Group on the Diabetic Foot and American Diabetes Association. Electronic searches of Cochrane Library, EBSCO Megafile Ultimate and EMBASE were performed to May 2021. Articles were included if they reported on the reliability of recommended chairside tests in diabetes cohorts. Quality appraisal was performed using a Quality Appraisal of Reliability Studies checklist and where possible, meta-analyses, with reliability reported as estimated Cohen’s kappa (95% CI). Seventeen studies were eligible for inclusion. Pooled analysis found acceptable inter-rater reliability of vibration perception threshold (VPT) (κ=0.61 (0.50 to 0.73)) and ankle reflex testing (κ=0.60 (0.55 to 0.64)), but weak inter-rater reliability for pinprick (κ=0.45 (0.22 to 0.69)) and 128 Hz tuning fork (κ=0.42 (0.15 to 0.70)), though intra-rater reliability of the 128 Hz tuning fork was moderate (κ=0.54 (0.37 to 0.73)). Inter-rater reliability of the four-site monofilament was acceptable (κ=0.61 (0.45 to 0.77)). These results support the clinical use of VPT, ankle reflexes and four-site monofilament for screening and ongoing monitoring of DPN as recommended by the latest guidelines. The reliability of temperature perception, pinprick, proprioception, three-site monofilament and Ipswich touch test when performed in people with diabetes remains unclear.


F1000Research ◽  
2019 ◽  
Vol 8 ◽  
pp. 221 ◽  
Author(s):  
Assem M. Khamis ◽  
Lara A. Kahale ◽  
Hector Pardo-Hernandez ◽  
Holger J. Schünemann ◽  
Elie A. Akl

Background: The living systematic review (LSR) is an emerging approach for improved evidence synthesis that uses continual updating to include relevant new evidence as soon as it is published. The objectives of this study are to: 1) assess the methods of conduct and reporting of living systematic reviews using a living study approach; and 2) describe the life cycle of living systematic reviews, i.e., describe the changes over time to their methods and findings. Methods: For objective 1, we will begin by conducting a cross-sectional survey and then update its findings every 6 months by including newly published LSRs. For objective 2, we will conduct a prospective longitudinal follow-up of the cohort of included LSRs. To identify LSRs, we will continually search the following electronic databases: Medline, EMBASE and the Cochrane library. We will also contact groups conducting LSRs to identify eligible studies that we might have missed. We will follow the standard systematic review methodology for study selection and data abstraction. For each LSR update, we will abstract information on the following: 1) general characteristics, 2) systematic review methodology, 3) living approach methodology, 4) results, and 5) editorial and publication processes. We will update the findings of both the surveys and the longitudinal follow-up of included LSRs every 6 months. In addition, we will identify articles addressing LSR methods to be included in an ‘LSR methods repository’. Conclusion: The proposed living methodological survey will allow us to monitor how the methods of conduct, and reporting as well as the findings of LSRs change over time. Ultimately this should help with ensuring the quality and transparency of LSRs.


BMJ Open ◽  
2019 ◽  
Vol 9 (12) ◽  
pp. e033962 ◽  
Author(s):  
Corbin Walters ◽  
Zachery J Harter ◽  
Cole Wayant ◽  
Nam Vo ◽  
Michael Warren ◽  
...  

ObjectivesAs much as 50%–90% of research is estimated to be irreproducible, costing upwards of $28 billion in USA alone. Reproducible research practices are essential to improving the reproducibility and transparency of biomedical research, such as including preregistering studies, publishing a protocol, making research data and metadata publicly available, and publishing in open access journals. Here we report an investigation of key reproducible or transparent research practices in the published oncology literature.DesignWe performed a cross-sectional analysis of a random sample of 300 oncology publications published from 2014 to 2018. We extracted key reproducibility and transparency characteristics in a duplicative fashion by blinded investigators using a pilot tested Google Form.Primary outcome measuresThe primary outcome of this investigation is the frequency of key reproducible or transparent research practices followed in published biomedical and clinical oncology literature.ResultsOf the 300 publications randomly sampled, 296 were analysed for reproducibility characteristics. Of these 296 publications, 194 contained empirical data that could be analysed for reproducible and transparent research practices. Raw data were available for nine studies (4.6%). Five publications (2.6%) provided a protocol. Despite our sample including 15 clinical trials and 7 systematic reviews/meta-analyses, only 7 included a preregistration statement. Less than 25% (65/194) of publications provided an author conflict of interest statement.ConclusionWe found that key reproducibility and transparency characteristics were absent from a random sample of published oncology publications. We recommend required preregistration for all eligible trials and systematic reviews, published protocols for all manuscripts, and deposition of raw data and metadata in public repositories.


2022 ◽  
Vol 8 ◽  
Author(s):  
Hui Pan ◽  
Mingyan Cai ◽  
Qi Liao ◽  
Yong Jiang ◽  
Yige Liu ◽  
...  

Objectives: Multiple meta-analyses which investigated the comparative efficacy and safety of artificial intelligence (AI)-aid colonoscopy (AIC) vs. conventional colonoscopy (CC) in the detection of polyp and adenoma have been published. However, a definitive conclusion has not yet been generated. This systematic review selected from discordant meta-analyses to draw a definitive conclusion about whether AIC is better than CC for the detection of polyp and adenoma.Methods: We comprehensively searched potentially eligible literature in PubMed, Embase, Cochrane library, and China National Knowledgement Infrastructure (CNKI) databases from their inceptions until to April 2021. Assessment of Multiple Systematic Reviews (AMSTAR) instrument was used to assess the methodological quality. Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) checklist was used to assess the reporting quality. Two investigators independently used the Jadad decision algorithm to select high-quality meta-analyses which summarized the best available evidence.Results: Seven meta-analyses met our selection criteria finally. AMSTAR score ranged from 8 to 10, and PRISMA score ranged from 23 to 26. According to the Jadad decision algorithm, two high-quality meta-analyses were selected. These two meta-analyses suggested that AIC was superior to CC for colonoscopy outcomes, especially for polyp detection rate (PDR) and adenoma detection rate (ADR).Conclusion: Based on the best available evidence, we conclude that AIC should be preferentially selected for the route screening of colorectal lesions because it has potential value of increasing the polyp and adenoma detection. However, the continued improvement of AIC in differentiating the shape and pathology of colorectal lesions is needed.


2022 ◽  
Vol 9 ◽  
Author(s):  
Rodolfo Castro ◽  
Marcelo Ribeiro-Alves ◽  
Cátia Oliveira ◽  
Carmen Phang Romero ◽  
Hugo Perazzo ◽  
...  

Background: Lifestyle Medicine (LM) aims to address six main behavioral domains: diet/nutrition, substance use (SU), physical activity (PA), social relationships, stress management, and sleep. Digital Health Interventions (DHIs) have been used to improve these domains. However, there is no consensus on how to measure lifestyle and its intermediate outcomes aside from measuring each behavior separately. We aimed to describe (1) the most frequent lifestyle domains addressed by DHIs, (2) the most frequent outcomes used to measure lifestyle changes, and (3) the most frequent DHI delivery methods.Methods: We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA-ScR) Extension for Scoping Reviews. A literature search was conducted using MEDLINE, Cochrane Library, EMBASE, and Web of Science for publications since 2010. We included systematic reviews and meta-analyses of clinical trials using DHI to promote health, behavioral, or lifestyle change.Results: Overall, 954 records were identified, and 72 systematic reviews were included. Of those, 35 conducted meta-analyses, 58 addressed diet/nutrition, and 60 focused on PA. Only one systematic review evaluated all six lifestyle domains simultaneously; 1 systematic review evaluated five lifestyle domains; 5 systematic reviews evaluated 4 lifestyle domains; 14 systematic reviews evaluated 3 lifestyle domains; and the remaining 52 systematic reviews evaluated only one or two domains. The most frequently evaluated domains were diet/nutrition and PA. The most frequent DHI delivery methods were smartphone apps and websites.Discussion: The concept of lifestyle is still unclear and fragmented, making it hard to evaluate the complex interconnections of unhealthy behaviors, and their impact on health. Clarifying this concept, refining its operationalization, and defining the reporting guidelines should be considered as the current research priorities. DHIs have the potential to improve lifestyle at primary, secondary, and tertiary levels of prevention—but most of them are targeting clinical populations. Although important advances have been made to evaluate DHIs, some of their characteristics, such as the rate at which they become obsolete, will require innovative research designs to evaluate long-term outcomes in health.


2019 ◽  
Vol 1 ◽  
pp. 24
Author(s):  
Jennifer Cooney ◽  
Caragh Flannery ◽  
Ali S. Khashan ◽  
Anja C. Huizink ◽  
Karen Matvienko-Sikar

Background: Childhood obesity presents a significant public health challenge globally. The period from conception to two years after birth, the first 1000 days, represents a critical period during which the experience of maternal stress may be related to the development of childhood obesity.  Research to date suggests some positive associations between maternal stress during the first 1000 days and childhood obesity, but findings are inconsistent and have not yet been comprehensively synthesised. The purpose of this review is to systematically examine the association between maternal stress during the first 1000 days and the risk of child overweight and obesity. Methods: The following electronic databases will be searched from inception using a detailed search strategy: the Cochrane Library, MEDLINE, PsycINFO, EMBASE, CINAHL, Maternity and Infant Care, and Web of Science. Cohort, case-control, and cross-sectional studies examining maternal stress during the first 1000 days and child overweight and obesity up to the age of 10 years will be included. Titles, abstracts and full articles will be screened by two investigators independently to identify eligible studies. A standardised data extraction form will be used to extract data including: study design; maternal stress exposure; child outcome; exclusion criteria; participant characteristics; and assessment methods. The Cochrane Collaboration’s bias classification tool for observational studies will be used to assess study quality. This protocol is reported according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses protocol (PRISMA-P) checklist, and the systematic review will be conducted and reported following the PRISMA checklist. If possible, random effects models will be used to perform meta-analyses. Ethics and dissemination: Ethical approval is not required for this study as it will not involve conducting experimental research, nor include identifying personal data.  The systematic review will be disseminated in peer-reviewed journals. PROSPERO registration number: CRD42018100363


2021 ◽  
pp. 193229682110646
Author(s):  
Stine Hangaard ◽  
Sisse H. Laursen ◽  
Jonas D. Andersen ◽  
Thomas Kronborg ◽  
Peter Vestergaard ◽  
...  

Background: Previous systematic reviews have aimed to clarify the effect of telemedicine on diabetes. However, such reviews often have a narrow focus, which calls for a more comprehensive systematic review within the field. Hence, the objective of the present systematic review, meta-analysis, and meta-regression is to evaluate the effectiveness of telemedicine solutions versus any comparator without the use of telemedicine on diabetes-related outcomes among adult patients with type 2 diabetes (T2D). Methods: This review was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. We considered telemedicine randomized controlled trials (RCT) including adults (≥18 years) diagnosed with T2D. Change in glycated hemoglobin (HbA1c, %) was the primary outcome. PubMed, EMBASE, and the Cochrane Library Central Register of Controlled Trials (CENTRAL) were searched on October 14, 2020. An overall treatment effect was estimated using a meta-analysis performed on the pool of included studies based on the mean difference (MD). The revised Cochrane risk-of-bias tool was applied and the certainty of evidence was graded using the Grading of Recommendations, Assessment, Development and Evaluations (GRADE) approach. Results: The final sample of papers included a total of 246, of which 168 had sufficient information to calculate the effect of HbA1c%. The results favored telemedicine, with an MD of −0.415% (95% confidence interval [CI] = −0.482% to −0.348%). The heterogeneity was great (I2 = 93.05%). A monitoring component gave rise to the higher effects of telemedicine. Conclusions: In conclusion, telemedicine may serve as a valuable supplement to usual care for patients with T2D. The inclusion of a telemonitoring component seems to increase the effect of telemedicine.


Author(s):  
Pei-Yu Wu ◽  
Kuei-Min Chen ◽  
Wan-Chi Tsai

ABSTRACT This systematic review and meta-analysis aimed to explore the association between the Mediterranean dietary pattern and inflammation in older adults. The Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines were followed. A search of the literature was conducted up to June 2020 in 7 electronic databases, namely PubMed, Embase, Web of Science, Scopus, Cochrane Library, Cumulative Index to Nursing and Allied Health Literature (CINAHL), and ProQuest. The Joanna Briggs Institute Critical Appraisal Checklists and the Newcastle-Ottawa Scale were used to assess the methodological quality. The overall standardized mean difference (SMD) and 95% CIs were estimated in random-effects meta-analyses. Thirteen studies were identified as having acceptable quality and were included in this systematic review: 3 randomized controlled trials (RCTs), 1 quasi-experimental study, 1 cohort study, and 8 cross-sectional studies. The circulating C-reactive protein (CRP) concentration was the most common inflammation indicator used. Results of the meta-analysis on 5 cross-sectional studies revealed a significant inverse association between the Mediterranean dietary pattern and inflammation as assessed by CRP (SMD = −0.26; 95% CI: −0.41, −0.11; P < 0.001). Other studies that investigated a variety of inflammation indicators other than CRP showed mixed results with regard to the relation between the Mediterranean dietary pattern and inflammation in older adults. Our findings suggest that the Mediterranean dietary pattern may be associated with lower inflammation in older adults. However, more long-term RCTs are required to demonstrate the effects of the Mediterranean dietary pattern on multiple inflammation parameters in older adults. The study has been registered on PROSPERO (#CRD42020140145).


2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. A1015-A1016
Author(s):  
Anida Divanovic ◽  
Maralyn Rose Druce

Abstract Background: Neuroendocrine tumours (NETs) are a wide-ranging group of neoplasms originating from neuroendocrine cells. In 2014 NETs incidence was 7 per 100000 people annually. The purpose of this systematic review is to evaluate the safety and efficacy of various types of chemotherapeutic agents on gastroenteropancreatic NETs (GEP NETs) and to determine which type of chemotherapy is the most effective for different tumour types, with minimum adverse events. To our knowledge, this study is the first systematic review that compares several types of chemotherapy and evaluates their safety and efficacy on GEP NETs. Methods: The study followed recommendations of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines on reporting systematic reviews. The literature search for this systematic review was conducted using the following databases and search engines: Cochrane library, EMBASE, Google Scholar, PubMed, and Web of Science, from 1963 to 2020. Results: The review comprised 26 observational studies, and 5 randomized controlled trials (RCTs). The total number of subjects included in this study was 1783. Our study showed that the most effective treatment for Grade 3 NETs and Grade 3 neuroendocrine carcinomas was cisplatin/etoposide. Furthermore, capecitabin/temozolomide therapy has been shown to be most effective in Grade 1 and Grade 2 NETs. Conclusion: Therapy with two chemotherapeutic agents has been shown to be more effective than monotherapy and therapy with three chemotherapeutic agents. Unfortunately, our study has limitations and we urgently need RCTs or larger observational studies that will contain all the necessary efficacy and safety tools, and thus provide answers to our clinical questions.


2020 ◽  
Author(s):  
Hervé Tchala Vignon Zomahoun ◽  
José Massougbodji ◽  
André Bussières ◽  
Aliki Thomas ◽  
Dahlia Kairy ◽  
...  

Abstract Background: The literature on the implementation of knowledge products is extensive. However, this literature is still difficult to interpret for policymakers and other stakeholders when faced with choosing implementation strategies likely to bring about successful change in their health systems. This work has the particularity to examine the scope of this literature, and to clarify the effectiveness of implementation strategies for different knowledge products. Consequently, we aim to: 1) determine the strengths and weaknesses of existing literature overviews; 2) produce a detailed portrait of the literature on implementation strategies for various knowledge products; and 3) assess the effectiveness of implementation strategies for each knowledge product identified and classify them.Methods: We will use a three-phase approach consisting of a critical analysis of existing literature overviews, a systematic review of systematic reviews, and a series of systematic reviews and meta-analyses. We will follow the Cochrane Methodology for each of three phases. Our eligibility criteria are defined following a PICOS approach: Population, individuals or stakeholders participating in healthcare delivery, specifically, healthcare providers, caregivers, and end users; Intervention, any type of strategy aiming to implement a knowledge product including, but not limited to, a decision support tool, a clinical practice guideline, a policy brief, or a decision-making tool, a one-pager, or a health intervention; Comparison, any comparator will be considered; Outcomes, Phases 1 and 2 – any outcome related to implementation strategies including, but not limited to, the measures of adherence/fidelity to the use of knowledge products, their acceptability, adoption, appropriateness, feasibility, adaptability, implementation costs, penetration/reach and sustainability; Phase 3 – any additional outcome related to patients (psychosocial, health behavioral, and clinical outcomes) or healthcare professionals (behavioral and performance outcomes); Setting, primary healthcare has to be covered. We will search MEDLINE (Ovid), EMBASE, Web of Science, PsycINFO, CINAHL, and the Cochrane Library from their inception onwards. For each phase, two reviewers will independently perform the selection of studies, data extraction, and assess their methodological quality. We will analyze extracted data, and perform narrative syntheses, and meta-analyses when possible.Discussion: Our results could inform not only the overviews’ methodology, but also the development of an online platform for the implementation strategies of knowledge products. This platform could be useful for stakeholders in implementation science.Systematic review registration: Protocol registered on Open science Framework, https://osf.io/hqbx8


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