scholarly journals The automation of relevant trial registration screening for systematic review updates: an evaluation study on a large dataset of ClinicalTrials.gov registrations

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Didi Surian ◽  
Florence T. Bourgeois ◽  
Adam G. Dunn
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Hierarchical Clustering ◽  
Systematic Reviews ◽  
Euclidean Distance ◽  
Latent Dirichlet Allocation ◽  
Feature Representation ◽  
Large Set ◽  
Document Similarity

Abstract Background Clinical trial registries can be used as sources of clinical evidence for systematic review synthesis and updating. Our aim was to evaluate methods for identifying clinical trial registrations that should be screened for inclusion in updates of published systematic reviews. Methods A set of 4644 clinical trial registrations (ClinicalTrials.gov) included in 1089 systematic reviews (PubMed) were used to evaluate two methods (document similarity and hierarchical clustering) and representations (L2-normalised TF-IDF, Latent Dirichlet Allocation, and Doc2Vec) for ranking 163,501 completed clinical trials by relevance. Clinical trial registrations were ranked for each systematic review using seeding clinical trials, simulating how new relevant clinical trials could be automatically identified for an update. Performance was measured by the number of clinical trials that need to be screened to identify all relevant clinical trials. Results Using the document similarity method with TF-IDF feature representation and Euclidean distance metric, all relevant clinical trials for half of the systematic reviews were identified after screening 99 trials (IQR 19 to 491). The best-performing hierarchical clustering was using Ward agglomerative clustering (with TF-IDF representation and Euclidean distance) and needed to screen 501 clinical trials (IQR 43 to 4363) to achieve the same result. Conclusion An evaluation using a large set of mined links between published systematic reviews and clinical trial registrations showed that document similarity outperformed hierarchical clustering for identifying relevant clinical trials to include in systematic review updates.

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.

Increasing underrepresented minority cancer patient enrollment into cancer clinical trials: A systematic review.

2021 ◽  
Vol 39 (15_suppl) ◽  
pp. e18574-e18574
Author(s):  
Rosa Nouvini ◽  
Patricia A. Parker ◽  
Charlotte Malling ◽  
Kendra Godwin ◽  
Rosario Costas-Muñiz
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Minority Groups ◽  
Relationship Building ◽  
Institutional Research ◽  
Underrepresented Minority ◽  
Randomized Controlled ◽  
Clinical Trial Enrollment ◽  
Recruitment Model

e18574 Background: Minorities continue to be underrepresented in clinical trials despite the National Institute of Health’s Revitalization Act, passed in 1993, mandating the representation of women and underrepresented minority groups in clinical trials. Studies have shown that although Blacks represent 15% and Hispanics 13% of the cancer population, their clinical trial enrollment rates in are disproportionately low at 4-6% and 3-6% respectively. We conducted a systematic review exploring interventions aimed at improving clinical trial enrollment for racial and ethnic minorities. Methods: A systematic search of PubMed, Cochrane CENTRAL, and Ovid PsycINFO was conducted for English-language studies of humans since 1993. Inclusion criteria included peer-reviewed, U.S.-based studies with interventions aimed to recruit underrepresented minority adult cancer patients into cancer clinical trials. We defined underrepresented minority groups as Black, Hispanic/Latino, Asian, American Indian/Alaska Native and Native Hawaiian/other Pacific Islander. Results: A total of 2471 titles and abstracts were identified and 2324 were excluded based on the eligibility criteria. A full text review was conducted of the remaining 147 articles, of which only 9 met criteria for our review. The interventions included patient navigation/coaching (n = 4), a clinical trial educational video (n = 2), institutional research infrastructure changes (n = 1), a relationship building and social marketing recruitment model (n = 1) and cultural competency training for providers (n = 1). Studies were conducted in a variety of practice settings including national cancer institutes and community practices. The quality of evidence was limited by the heterogeneity of study methods, patient representation and bias. Several studies had a homogeneous population of Black patients. Most studies (n = 7) were single arm trials that compared results to either historical controls or those cited in the existing literature; two studies were randomized controlled trials. A statistically significant improvement in accrual was shown in three of the patient navigation interventions, one of the clinical trial educational videos, the institutional research infrastructure change and the relationship building and social marketing recruitment model. The common threads to many of these successful interventions were support through the cancer care continuum, cultural congruency of research staff and culturally catered clinical trial educational materials. Conclusions: This systematic review illustrates several mechanisms by which to increase cancer clinical trial recruitment for cancer patients of underrepresented minority backgrounds in a variety of clinical settings. Randomized controlled trials with representation of multiple races/ethnicities are needed to further explore the benefits of these interventions.

Guidance for reporting clinical trial registry records and published protocols use in systematic reviews of interventions

2019 ◽  
Author(s):  
Julia Bidonde ◽  
Jose Francisco Meneses-Echavez ◽  
Angela Jean Busch ◽  
Catherine Boden
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Systematic Reviews ◽  
Cochrane Collaboration ◽  
Subject Area ◽  
Selective Reporting ◽  
Trial Registry ◽  
Clinical Trial Registry ◽  
Reporting Practices ◽  
Starting Point

Abstract Background: Transparency is a tenet of systematic reviews. Searching for clinical trial registry records and published protocols has become a mandatory standard when conducting a systematic review of interventions. However, there is no comprehensive guidance for review authors on how to report the use of registry records and published protocols in their systematic review. The objective of this study was to generate initial guidance to assist authors of systematic reviews of interventions in the reporting of registry records and published protocols in systematic reviews of interventions. Methods: We used a compilation of the procedures recommended by expert organizations (e.g., Cochrane Collaboration) related to the reporting of use of registry records and published protocols in the conduct of systematic reviews. The compilation was developed by one of the authors in this study and served as a starting point in developing the algorithm. We extracted current practice data related to registry records and published protocols from a stratified random sample of Cochrane systematic reviews of interventions published between 2015 and 2016 (n=169). We identified examples that adhered to or extended the current guidance. Based on the on the elements above, we created the algorithm to bridge gaps and improve current reporting practices. Results: Trial protocols should be used to account for all evidence in a subject area, evaluate reporting bias (i.e. selective reporting and publication bias), and determine the nature and number of ongoing or unpublished studies for planning review updates. Review authors’ terminology (e.g., ongoing, terminated) and consequent reporting in the review should reflect the phase of the trial found. Protocols should be clearly and consistently reported throughout the review (e.g. abstract, methods, results) as is done with published articles. Conclusions: Our study expands on available guidance to describe in greater detail the reporting of registry records and published protocols for review authors. We believe this is a timely investigation that will increase transparency in the reporting of trial records in systematic reviews of interventions and bring clarification to current fuzziness in terminology. We invite researchers to provide feedback on our work for its improvement and dissemination. Trial Registration: not applicable

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.

Best supportive care (BSC) in published clinical trials.

2013 ◽  
Vol 31 (15_suppl) ◽  
pp. 9560-9560 ◽  
Author(s):  
Amy Pickar Abernethy ◽  
Ryan David Nipp ◽  
David Currow ◽  
Nathan Cherny ◽  
Florian Strasser ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Supportive Care ◽  
Symptom Management ◽  
Symptom Assessment ◽  
Best Supportive Care ◽  
Delphi Panel ◽  
Random Allocation ◽  
Exclusion Criteria

9560 Background: BSC as a control arm in clinical trials is poorly defined. A systematic review was conducted to evaluate clinical trial concordance with published, consensus-based framework for BSC delivery in trials. Methods: A consensus-based Delphi panel previously identified 4 key domains of BSC delivery in trials: multidisciplinary care; supportive care documentation; symptom assessment at least as often as the intervention arm; and guideline-based symptom management. A systematic review of trials including BSC control arms assessed BSC concordance to the consensus-based domains. Databases were searched from 2002-2012 using search strings: “cancer”; “best supportive care”; “randomized” or “random allocation”; and “supportive” or “palliative.” Exclusion criteria were: no BSC arm, non-human trial, not randomized, not English, not advanced cancer, or not including anticancer therapy. Data were independently extracted by 2 reviewers and scored by 4 reviewers for conformance with consensus-based BSC framework. Results: 373 articles were retrieved, 17 retained after applying exclusion criteria. Overall, trials conformed to <18% of the consensus-based BSC standards. 35% of articles offered a detailed description of BSC. 65% reported baseline and regular symptom assessment, and 47% reported using validated symptom assessment measures. 35% reported symptom assessment at identical intervals in both experimental and BSC arms. None listed an evidence-based guideline for symptom management. None of the multicenter trials reported standardization of BSC across sites. No studies reported educating patients on symptom management or goals of anti-cancer therapy. No studies reported offering access to palliative care specialists, social workers, financial or spiritual counseling. Conclusions: Reporting of BSC in trials is incomplete, resulting in uncertain internal and external validity. Such poorly defined interventions and variation between sites is unacceptable for other aspects of a clinical trial. Unless it is truly best supportive care, such studies may risk systematically over-estimating the clinical effect of the comparator arms. Standardization of a BSC delivery framework is needed to improve trial design and data generalization.

scholarly journals Identifying patient-important outcomes for treatment of bipolar disorder: a systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (12) ◽  
pp. e050453
Author(s):  
Alessia D'Elia ◽  
Olivia Orsini ◽  
Stephanie Sanger ◽  
Alannah Hillmer ◽  
Nitika Sanger ◽  
...  
Keyword(s):  
Systematic Review ◽  
Bipolar Disorder ◽  
Clinical Trials ◽  
Systematic Reviews ◽  
Treatment Effectiveness ◽  
Data Extraction ◽  
Risk Of Bias ◽  
Observational Research ◽  
Cochrane Library ◽  
Randomised Controlled

IntroductionTreatment of bipolar disorder is the focus of several clinical trials, however the understanding of the outcomes for establishing treatment effectiveness within these trials is limited. Further, there is limited literature which reports on the outcomes considered to be important to patients, indicating that patient perspectives are often not considered when selecting outcomes of effectiveness within trials. This protocol describes a systematic review which aims to describe the outcomes being used within trials to measure treatment effectiveness, commenting on the inclusion of patient-important outcomes within previous trials.Methods and analysisThis protocol is reported using the Preferred Reporting Items for Systematic Reviews and Meta-analyses Protocols statement. OVID MEDLINE, OVID Embase, OVID APA PsycINFO, Web of Science, the Wiley Cochrane Library, ClinicalTrials.gov and the International Clinical Trials Registry Platform databases will be searched for eligible studies. Screening, full-text and data extraction stages will be completed in duplicate using the Covidence platform for systematic reviews. Eligible studies will include clinical trials of interventions in bipolar disorder, in order to identify outcomes used to assess treatment effectiveness, and qualitative studies, to determine which outcomes have been reported as important by patients. Risk of bias for included studies will be assessed using the Cochrane Risk of Bias Tool for randomised controlled trials, and the Newcastle-Ottawa Scale for observational research.Ethics and disseminationThis review will involve dissemination to key stakeholders, including primary end users such as patients, clinicians and trialists. Knowledge translation tools will be generated to share the relevant conclusions of this review. Results will be communicated to the scientific community through peer-reviewed publications, conferences and workshops. No ethics approval will be sought as this study is based on literature.PROSPERO registration numberCRD42021214435.

scholarly journals A living systematic review protocol for COVID-19 clinical trial registrations

2020 ◽  
Vol 5 ◽  
pp. 60 ◽  
Author(s):  
Brittany J. Maguire ◽  
Philippe J. Guérin
Keyword(s):  
Systematic Review ◽  
Clinical Trial ◽  
Clinical Trials ◽  
Data Extraction ◽  
Meta Analysis ◽  
Geographic Location ◽  
Diagnostic Methods ◽  
Future Research ◽  
Strong Response ◽  
Level Of Evidence

Since the coronavirus disease 2019 (COVID-19) outbreak was identified in December 2019 in Wuhan, China, a strong response from the research community has been observed with the proliferation of independent clinical trials assessing diagnostic methods, therapeutic and prophylactic strategies. While there is no intervention for the prevention or treatment of COVID-19 with proven clinical efficacy to date, tools to distil the current research landscape by intervention, level of evidence and those studies likely powered to address future research questions is essential. This living systematic review aims to provide an open, accessible and frequently updated resource summarising the characteristics of COVID-19 clinical trial registrations. Weekly search updates of the WHO International Clinical Trials Registry Platform (ICTRP) and source registries will be conducted. Data extraction by two independent reviewers of trial characteristic variables including categorisation of trial design, geographic location, intervention type and targets, level of evidence and intervention adaptability to low resource settings will be completed. Descriptive and thematic synthesis will be conducted. A searchable and interactive visualisation of the results database will be created, and made openly available online. Weekly results from the continued search updates will be published and made available on the Infectious Diseases Data Observatory (IDDO) website (COVID-19 website). This living systematic review will provide a useful resource of COVID-19 clinical trial registrations for researchers in a rapidly evolving context. In the future, this sustained review will allow prioritisation of research targets for individual patient data meta-analysis.

scholarly journals Eysenbach, Tuische and Diepgen’s Evaluation of Web Searching for Identifying Unpublished Studies for Systematic Reviews: An Innovative Study Which is Still Relevant Today

2016 ◽  
Vol 11 (3) ◽  
pp. 108
Author(s):  
Simon Briscoe
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Search Engine ◽  
Systematic Reviews ◽  
Search Engines ◽  
Web Search ◽  
Web Searching ◽  
Web Searches ◽  
Web Search Engine ◽  
Unpublished Studies

A Review of: Eysenbach, G., Tuische, J. & Diepgen, T.L. (2001). Evaluation of the usefulness of Internet searches to identify unpublished clinical trials for systematic reviews. Medical Informatics and the Internet in Medicine, 26(3), 203-218. http://dx.doi.org/10.1080/14639230110075459 Objective – To consider whether web searching is a useful method for identifying unpublished studies for inclusion in systematic reviews. Design – Retrospective web searches using the AltaVista search engine were conducted to identify unpublished studies – specifically, clinical trials – for systematic reviews which did not use a web search engine. Setting – The Department of Clinical Social Medicine, University of Heidelberg, Germany. Subjects – n/a Methods – Pilot testing of 11 web search engines was carried out to determine which could handle complex search queries. Pre-specified search requirements included the ability to handle Boolean and proximity operators, and truncation searching. A total of seven Cochrane systematic reviews were randomly selected from the Cochrane Library Issue 2, 1998, and their bibliographic database search strategies were adapted for the web search engine, AltaVista. Each adaptation combined search terms for the intervention, problem, and study type in the systematic review. Hints to planned, ongoing, or unpublished studies retrieved by the search engine, which were not cited in the systematic reviews, were followed up by visiting websites and contacting authors for further details when required. The authors of the systematic reviews were then contacted and asked to comment on the potential relevance of the identified studies. Main Results – Hints to 14 unpublished and potentially relevant studies, corresponding to 4 of the 7 randomly selected Cochrane systematic reviews, were identified. Out of the 14 studies, 2 were considered irrelevant to the corresponding systematic review by the systematic review authors. The relevance of a further three studies could not be clearly ascertained. This left nine studies which were considered relevant to a systematic review. In addition to this main finding, the pilot study to identify suitable search engines found that AltaVista was the only search engine able to handle the complex searches required to search for unpublished studies. Conclusion –Web searches using a search engine have the potential to identify studies for systematic reviews. Web search engines have considerable limitations which impede the identification of studies.

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