scholarly journals An investigation into the impact and implications of published papers from retracted research: systematic search of affected literature

BMJ Open ◽  
2019 ◽  
Vol 9 (10) ◽  
pp. e031909 ◽  
Author(s):  
Alison Avenell ◽  
Fiona Stewart ◽  
Andrew Grey ◽  
Greg Gamble ◽  
Mark Bolland
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Research Misconduct ◽  
Evidence Base ◽  
Bibliographic Databases ◽  
Potential Influence ◽  
Relevant Research ◽  
Meta Analyses ◽  
The Impact

ObjectiveAnalyses of the impact of a body of clinical trial reports subject to research misconduct have been few. Our objective was to examine the impact on clinically relevant research of a group of researchers’ trial reports (‘affected trial reports’) affected by research misconduct, and whether identification of misconduct invoked a reappraisal.DesignIn 2016, we used five databases and search engines to identify ‘citing publications’, that is, guidelines, systematic and other reviews, and clinical trials citing any of 12 affected trial reports, published 1998–2011, eventually retracted for research misconduct. The affected trial reports were assessed more likely to have had impact because they had hip fracture outcomes and were in journals with impact factor >4. Two authors assessed whether findings of the citing publications would change if the affected trial reports were removed. In 2018, we searched for evidence that the citing publications had undertaken a reassessment as a result of the potential influence of the affected trial reports.ResultsBy 2016 the affected trial reports were cited in 1158 publications, including 68 systematic reviews, meta-analyses, narrative reviews, guidelines and clinical trials. We judged that 13 guidelines, systematic or other reviews would likely change their findings if the affected trial reports were removed, and in another eight it was unclear if findings would change. By 2018, only one of the 68 citing publications, a systematic review, appeared to have undertaken a reassessment, which led to a correction.ConclusionsWe found evidence that this group of affected trial reports distorted the evidence base. Correction of these distortions is slow, uncoordinated and inconsistent. Unless there is a rapid, systematic, coordinated approach by bibliographic databases, authors, journals and publishers to mitigate the impact of known cases of research misconduct, patients, other researchers and their funders may continue to be adversely affected.

scholarly journals Impact of patient and public involvement on enrolment and retention in clinical trials: systematic review and meta-analysis

BMJ ◽  
2018 ◽  
pp. k4738 ◽  
Author(s):  
Joanna C Crocker ◽  
Ignacio Ricci-Cabello ◽  
Adwoa Parker ◽  
Jennifer A Hirst ◽  
Alan Chant ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Lived Experience ◽  
Odds Ratio ◽  
Public Involvement ◽  
Meta Analysis ◽  
Patient And Public Involvement ◽  
Retention Rates ◽  
The Impact

AbstractObjectiveTo investigate the impact of patient and public involvement (PPI) on rates of enrolment and retention in clinical trials and explore how this varies with the context and nature of PPI.DesignSystematic review and meta-analysis.Data sourcesTen electronic databases, including Medline, INVOLVE Evidence Library, and clinical trial registries.Eligibility criteriaExperimental and observational studies quantitatively evaluating the impact of a PPI intervention, compared with no intervention or non-PPI intervention(s), on participant enrolment and/or retention rates in a clinical trial or trials. PPI interventions could include additional non-PPI components inseparable from the PPI (for example, other stakeholder involvement).Data extraction and analysisTwo independent reviewers extracted data on enrolment and retention rates, as well as on the context and characteristics of PPI intervention, and assessed risk of bias. Random effects meta-analyses were used to determine the average effect of PPI interventions on enrolment and retention in clinical trials: main analysis including randomised studies only, secondary analysis adding non-randomised studies, and several exploratory subgroup and sensitivity analyses.Results26 studies were included in the review; 19 were eligible for enrolment meta-analysis and five for retention meta-analysis. Various PPI interventions were identified with different degrees of involvement, different numbers and types of people involved, and input at different stages of the trial process. On average, PPI interventions modestly but significantly increased the odds of participant enrolment in the main analysis (odds ratio 1.16, 95% confidence interval and prediction interval 1.01 to 1.34). Non-PPI components of interventions may have contributed to this effect. In exploratory subgroup analyses, the involvement of people with lived experience of the condition under study was significantly associated with improved enrolment (odds ratio 3.14v1.07; P=0.02). The findings for retention were inconclusive owing to the paucity of eligible studies (odds ratio 1.16, 95% confidence interval 0.33 to 4.14), for main analysis).ConclusionsThese findings add weight to the case for PPI in clinical trials by indicating that it is likely to improve enrolment of participants, especially if it includes people with lived experience of the health condition under study. Further research is needed to assess which types of PPI work best in particular contexts, the cost effectiveness of PPI, the impact of PPI at earlier stages of trial design, and the impact of PPI interventions specifically targeting retention.Systematic review registrationPROSPERO CRD42016043808.

scholarly journals The impact of patient-reported outcome (PRO) data from clinical trials: a systematic review and critical analysis

2019 ◽  
Vol 17 (1) ◽  
Author(s):  
Samantha Cruz Rivera ◽  
Derek G. Kyte ◽  
Olalekan Lee Aiyegbusi ◽  
Anita L. Slade ◽  
Christel McMullan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Case Studies ◽  
Real World ◽  
Clinical Trial Data ◽  
Research Impact ◽  
Trial Data ◽  
Patient Reported ◽  
The Impact

Abstract Background Patient-reported outcomes (PROs) are commonly collected in clinical trials and should provide impactful evidence on the effect of interventions on patient symptoms and quality of life. However, it is unclear how PRO impact is currently realised in practice. In addition, the different types of impact associated with PRO trial results, their barriers and facilitators, and appropriate impact metrics are not well defined. Therefore, our objectives were: i) to determine the range of potential impacts from PRO clinical trial data, ii) identify potential PRO impact metrics and iii) identify barriers/facilitators to maximising PRO impact; and iv) to examine real-world evidence of PRO trial data impact based on Research Excellence Framework (REF) impact case studies. Methods Two independent investigators searched MEDLINE, EMBASE, CINAHL+, HMIC databases from inception until December 2018. Articles were eligible if they discussed research impact in the context of PRO clinical trial data. In addition, the REF 2014 database was systematically searched. REF impact case studies were included if they incorporated PRO data in a clinical trial. Results Thirty-nine publications of eleven thousand four hundred eighty screened met the inclusion criteria. Nine types of PRO trial impact were identified; the most frequent of which centred around PRO data informing clinical decision-making. The included publications identified several barriers and facilitators around PRO trial design, conduct, analysis and report that can hinder or promote the impact of PRO trial data. Sixty-nine out of two hundred nine screened REF 2014 case studies were included. 12 (17%) REF case studies led to demonstrable impact including changes to international guidelines; national guidelines; influencing cost-effectiveness analysis; and influencing drug approvals. Conclusions PRO trial data may potentially lead to a range of benefits for patients and society, which can be measured through appropriate impact metrics. However, in practice there is relatively limited evidence demonstrating directly attributable and indirect real world PRO-related research impact. In part, this is due to the wider challenges of measuring the impact of research and PRO-specific issues around design, conduct, analysis and reporting. Adherence to guidelines and multi-stakeholder collaboration is essential to maximise the use of PRO trial data, facilitate impact and minimise research waste. Trial registration Systematic Review registration PROSPERO CRD42017067799.

scholarly journals Considering the methodological limitations in the evidence base of antidepressants for depression: a reanalysis of a network meta-analysis

BMJ Open ◽  
2019 ◽  
Vol 9 (6) ◽  
pp. e024886 ◽  
Author(s):  
Klaus Munkholm ◽  
Asger Sand Paludan-Müller ◽  
Kim Boesen
Keyword(s):  
Systematic Review ◽  
Clinical Study ◽  
Effect Size ◽  
Meta Analysis ◽  
Evidence Base ◽  
Risk Of Bias ◽  
Depression Symptom ◽  
Meta Analyses ◽  
The Impact ◽  
Clinical Study Reports

ObjectivesTo investigate whether the conclusion of a recent systematic review and network meta-analysis (Ciprianiet al) that antidepressants are more efficacious than placebo for adult depression was supported by the evidence.DesignReanalysis of a systematic review, with meta-analyses.Data sources522 trials (116 477 participants) as reported in the systematic review by Ciprianiet aland clinical study reports for 19 of these trials.AnalysisWe used the Cochrane Handbook’s risk of bias tool and the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach to evaluate the risk of bias and the certainty of evidence, respectively. The impact of several study characteristics and publication status was estimated using pairwise subgroup meta-analyses.ResultsSeveral methodological limitations in the evidence base of antidepressants were either unrecognised or underestimated in the systematic review by Ciprianiet al. The effect size for antidepressants versus placebo on investigator-rated depression symptom scales was higher in trials with a ‘placebo run-in’ study design compared with trials without a placebo run-in design (p=0.05). The effect size of antidepressants was higher in published trials compared with unpublished trials (p<0.0001). The outcome data reported by Ciprianiet aldiffered from the clinical study reports in 12 (63%) of 19 trials. The certainty of the evidence for the placebo-controlled comparisons should be very low according to GRADE due to a high risk of bias, indirectness of the evidence and publication bias. The mean difference between antidepressants and placebo on the 17-item Hamilton depression rating scale (range 0–52 points) was 1.97 points (95% CI 1.74 to 2.21).ConclusionsThe evidence does not support definitive conclusions regarding the benefits of antidepressants for depression in adults. It is unclear whether antidepressants are more efficacious than placebo.

The experience of conducting a Cochrane systematic review of the impact of clinical pathways on professional practice, patient outcomes, length of stay and hospital costs

2009 ◽  
Vol 13 (2) ◽  
pp. 62-66 ◽  
Author(s):  
Thomas Rotter ◽  
Leigh Kinsman ◽  
Erica James ◽  
Andreas Machotta ◽  
Holger Gothe ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Pathways ◽  
Hospital Costs ◽  
Evidence Base ◽  
Care Group ◽  
Level Of Evidence ◽  
Organisation Of Care ◽  
High Level ◽  
Meta Analyses ◽  
The Impact

Despite the high prevalence of clinical pathways (CPWs), the results from published studies are inconsistent and contradictory. The plethora of study designs, settings and lack of an agreed definition of a CPW make the relevance of individual studies difficult to apply to clinical settings. It was timely to catalogue and analyse the existing evidence base for CPWs via a rigorous systematic review. Systematic reviews and meta-analyses provide a high level of evidence for the effectiveness of interventions and are commonly employed reviewing strategies for addressing scientific questions in health-related research. This method is especially useful when research results are known to be inconsistent. Instead of conducting another primary evaluation, a detailed review is needed that reflects a summation of available research. This paper reports and discusses methodological and technical issues of a systematic review of the effectiveness of CPWs in hospitals, based on our experience with the Cochrane Effective Practice and Organisation of Care Group.

scholarly journals Double Burden of Malnutrition Among Migrants and Refugees in Developed Countries

2021 ◽  
Vol 4 ◽  
pp. 1-13
Author(s):  
Blessing Akombi-Inyang ◽  
Md. Nazmul Huda ◽  
Judith Byaruhanga ◽  
Andre Renzaho
Keyword(s):  
Systematic Review ◽  
Grey Literature ◽  
Developed Countries ◽  
Evidence Base ◽  
Bibliographic Databases ◽  
Double Burden ◽  
Ovid Medline ◽  
Double Burden Of Malnutrition ◽  
Meta Analyses

Background: The double burden of malnutrition (DBM) increases the risk of developing non-communicable diseases among migrant and refugee populations living in developed countries. This systematic review aims to examine the DBM among migrants and refugees in developed countries. It aims to appraise, synthesise, and summarise literature to create an evidence base that looks at multiple faces of DBM. Methods/Design: This protocol is informed by the standard Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocols (PRISMA-P) guidelines. A systematic review of peer-reviewed quantitative, qualitative and mixed-methods studies on DBM among migrants and refugees in developed countries will be undertaken. The review will include only studies published in English. Eight bibliographic databases will be searched: Ovid MEDLINE, EMBASE, PsycINFO, CINAHL, ProQuest, Scopus, PubMed, and web of science. Grey literature will also be searched. Studies that meet the inclusion criteria will be imported to Covidence. Screening for eligible studies will be conducted by two independent researchers. The quality of included studies will be appraised for risk of bias using validated tools. A narrative synthesis approach will be undertaken to report retrieved data. Discussion: The protocol provides insight into the scope and parameters of the systematic review to be conducted.

Preventive Interventions for the Second Half of Life: A Systematic Review

2017 ◽  
Vol 32 (4) ◽  
pp. 1122-1139 ◽  
Author(s):  
Cother Hajat ◽  
Adriana Selwyn ◽  
Mark Harris ◽  
Derek Yach
Keyword(s):  
Systematic Review ◽  
Healthy Aging ◽  
Data Extraction ◽  
Evidence Base ◽  
Noncommunicable Diseases ◽  
Level Of Evidence ◽  
Summary Table ◽  
Age Related ◽  
Meta Analyses ◽  
The Impact

Objective: Recent improvements in life expectancy globally require intensified focus on noncommunicable diseases and age-related conditions. The purpose of this article is to inform the development of age-specific prevention guidelines for adults aged 50 and above, which are currently lacking. Data Source: PubMed, Cochrane database, and Google Scholar and explicit outreach to experts in the field. Study Inclusion and Exclusion Criteria: Meta-analyses, intervention-based, and prospective cohort studies that reported all-cause mortality, disease-specific mortality, or morbidity in adults were included. Data Extraction: A systematic review was undertaken in 2015 using search terms of a combination of <risk factor> and “intervention,” “mortality,” “reduction,” “improvement,” “death,” and “morbidity.” Data Synthesis: Interventions were categorized according to the Center for Evidence-Based Medicine Level of Evidence framework. Results: A summary table reports for each intervention the impact, strength of evidence, initiation, duration, and details of the intervention. Age-decade-specific preventive recommendations have been proposed relating to physical activity, diet, tobacco and alcohol use, medication adherence, screening and vaccination, and mental and cognitive health. Conclusion: Clear recommendations have been made according to the existing evidence base, but further research investment is needed to fill the many gaps. Further, personalized approaches to healthy aging complemented by population-wide approaches and broader cross-sector partnerships will help to ensure greater longevity is an opportunity, rather than a burden, for society.

THE EFFECT OF ENGLISH-LANGUAGE RESTRICTION ON SYSTEMATIC REVIEW-BASED META-ANALYSES: A SYSTEMATIC REVIEW OF EMPIRICAL STUDIES

2012 ◽  
Vol 28 (2) ◽  
pp. 138-144 ◽  
Author(s):  
Andra Morrison ◽  
Julie Polisena ◽  
Don Husereau ◽  
Kristen Moulton ◽  
Michelle Clark ◽  
...  
Keyword(s):  
Systematic Review ◽  
English Language ◽  
Conventional Medicine ◽  
Empirical Studies ◽  
Grey Literature ◽  
Bibliographic Databases ◽  
Systematic Bias ◽  
Language Restriction ◽  
Meta Analyses ◽  
The Impact

Objectives:The English language is generally perceived to be the universal language of science. However, the exclusive reliance on English-language studies may not represent all of the evidence. Excluding languages other than English (LOE) may introduce a language bias and lead to erroneous conclusions.Study Design and Setting:We conducted a comprehensive literature search using bibliographic databases and grey literature sources. Studies were eligible for inclusion if they measured the effect of excluding randomized controlled trials (RCTs) reported in LOE from systematic review-based meta-analyses (SR/MA) for one or more outcomes.Results:None of the included studies found major differences between summary treatment effects in English-language restricted meta-analyses and LOE-inclusive meta-analyses. Findings differed about the methodological and reporting quality of trials reported in LOE. The precision of pooled estimates improved with the inclusion of LOE trials.Conclusions:Overall, we found no evidence of a systematic bias from the use of language restrictions in systematic review-based meta-analyses in conventional medicine. Further research is needed to determine the impact of language restriction on systematic reviews in particular fields of medicine.

scholarly journals What is the effect of giving the grazers access to additional nutrient sources on biodiversity in semi-natural pastures? A systematic review protocol

2021 ◽  
Vol 10 (1) ◽  
Author(s):  
Ida Envall ◽  
Jan Bengtsson ◽  
Simon Jakobsson ◽  
Maj Rundlöf ◽  
Charlotte Åberg ◽  
...  
Keyword(s):  
Systematic Review ◽  
Grey Literature ◽  
Evidence Base ◽  
Bibliographic Databases ◽  
Eligibility Criteria ◽  
Nutrient Sources ◽  
History Of ◽  
Review Protocol ◽  
Meta Analyses ◽  
Two Stages

Abstract Background Semi-natural pastures are unfertilized grasslands with a long history of traditional low-input grazing management. This kind of pastures are recognized for their high species richness. However, as a consequence of modernization of agriculture, many of the semi-natural pastures have been lost during the last century, leading to a serious threat to farmland biodiversity. Semi-natural pastures are relatively low in productivity. Hence, to increase profitability, farmers may want to give the grazing animals access to additional nutrient sources. This can be done either as supplementary feeding, or by fencing the semi-natural pastures into the same enclosure as improved, more nutrient-rich, pastures. These practices are, however, controversial. It is argued that since semi-natural pastures are species-rich partly because they are nutrient-poor, introducing additional nutrients into the system should be avoided. Accordingly, in Sweden, these interventions are often prohibited while receiving financial subsidies for management of semi-natural pastures. However, since many farmers are dependent on such support to maintain their pastures, these prohibitions often cause problems. The question has been raised whether giving the grazers access to additional nutrient sources really affect the biodiversity in semi-natural pastures, as is assumed. The primary aim of the proposed systematic review is to answer this question. Method Peer-reviewed and grey literature will be searched for using bibliographic databases, search engines, specialist websites and stakeholder contacts. The references will be screened for relevance according to a predefined set of eligibility criteria. The criteria will be tested and clarified iteratively, until consistency in interpretations is achieved. Thereafter, the literature will be screened in two stages, first based upon title and abstract and then by examining full texts. Full text screening will be performed with blinded decisions by two independent reviewers. Each relevant study will then be critically appraised, based on a set of predefined validity criteria. A narrative synthesis will be provided, outlining the evidence base in terms of bibliographic information and study metadata. If possible, quantitative syntheses based on meta-analyses will be performed. Identified relevant knowledge gaps will be highlighted and discussed.

scholarly journals Professional medical writing support and the quality, ethics and timeliness of clinical trial reporting: a systematic review

2018 ◽  
Author(s):  
Obaro Evuarherhe ◽  
William Gattrell ◽  
Richard White ◽  
Christopher Charles Winchester
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Medical Writing ◽  
Quality Of Reporting ◽  
Medical Publication ◽  
Number Of Citations ◽  
The Impact ◽  
The Relationship

Background: Many authors choose to work with professional medical writers when reporting the results of clinical trials. We conducted a systematic review to examine the relationship between professional medical writing support (PMWS) and the quality, ethics and timeliness of publications reporting clinical trials. Methods: Using terms related to medical writer and observational study, we searched MEDLINE and Embase (no date limits), as well as abstracts and posters from meetings of the International Society for Medical Publication Professionals (ISMPP; 2014-2017). We also hand-searched the journals Medical Writing and The Write Stuff (2014-2017), and the bibliographies of studies identified in the electronic searches. We screened the results to identify studies that compared the quality, ethics and timeliness of clinical trial publications written with and without declared PMWS. Results: Our searches identified 97 potentially relevant studies, of which 89 were excluded during screening and full paper review. The remaining eight studies compared 849 publications with PMWS with 2073 articles developed without such support. In these eight studies, PMWS was shown to be associated with: increased adherence to Consolidated Standards of Reporting Trials (CONSORT) guidelines (in 3/3 studies in which this was assessed); publication in journals with an impact factor (one study); a higher quality of written English (one study); and a lower likelihood of reporting non-pre-specified outcomes (one study). PMWS was not associated with increased adherence to CONSORT for Abstracts guidelines (one study) or with the impact of published articles (mean number of citations per year, mean number of article views per year and Altmetric score; one study). In studies that assessed timeliness of publication, PMWS was associated with a reduced time from last patient visit in clinical trials to primary publication (one study), whereas time from submission to acceptance showed inconsistent results (two studies). Conclusions: This systematic review of eight observational studies suggests that PMWS increases the overall quality of reporting of clinical trials and may improve the timeliness of publication.

scholarly journals Impact of Educational Technology on Teacher Stress and Anxiety: A Literature Review

2021 ◽  
Vol 18 (2) ◽  
pp. 548
Author(s):  
José-María Fernández-Batanero ◽  
Pedro Román-Graván ◽  
Miguel-María Reyes-Rebollo ◽  
Marta Montenegro-Rueda
Keyword(s):  
Systematic Review ◽  
Educational Technology ◽  
Teaching And Learning ◽  
Teaching Practice ◽  
Web Of Science ◽  
Teacher Stress ◽  
Bibliographic Databases ◽  
Technology In The Classroom ◽  
Stress Symptoms ◽  
Meta Analyses

Educational technology has become an increasingly important element for improving the teaching and learning process of students. To achieve these goals, it is essential that teachers have the skills they need to be able to introduce technology into their teaching practice. However, this is often overwhelming and stressful for many of them. The aim of this review was to find out how research on teacher stress and anxiety associated with the use of educational technology was proceeding. A systematic review was conducted using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines through the following bibliographic databases: PubMed, Web of Science, and Scopus. Sixteen articles were found from the review. The main findings show that teachers present high levels of anxiety or stress due to their use of educational technology in the classroom. Among the conclusions, the need for research on different strategies to prevent the emergence of these anxiety and stress symptoms in teachers stands out.

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