The use of FDI criteria in clinical trials on direct dental restorations: A scoping review

BACKGROUND Digital Therapeutics (DTx) provide evidence based therapeutic health interventions that have been clinically validated to deliver therapeutic outcomes, such that the software is the treatment. Digital methodologies are increasingly adopted to conduct clinical trials due to advantages they provide including increases in efficiency and decreases in trial costs. Digital therapeutics are digital by design and can leverage the potential of digital and remote clinical trial methods. OBJECTIVE The principal purpose of this scoping review is to review the literature to determine whether digital technologies are being used in DTx clinical research, which type are being used and whether publications are noting any advantages to their use. As DTx development is an emerging field there are likely gaps in the knowledge base regarding DTx and clinical trials, and the purpose of this review is to illuminate those gaps. A secondary purpose is to consider questions which emerged during the review process including whether fully remote digital clinical research is appropriate for all health conditions and whether digital clinical trial methods are inline with the principles of Good Clinical Practice. METHODS 1,326 records were identified by searching research databases and 1,227 reviewed at the full-article level in order to determine if they were appropriate for inclusion. Confirmation of clinical trial status, use of digital clinical research methods and digital therapeutic status as well as inclusion and exclusion criteria were applied in order to determine relevant articles. Digital methods employed in DTx research were extracted from each article and these data were synthesized in order to determine which digital methods are currently used in clinical trial research. RESULTS After applying our criteria for scoping review inclusion, 11 articles were identified. All articles used at least one form of digital clinical research methodology enabling an element of remote research. The most commonly used digital methods are those related to recruitment, enrollment and the assessment of outcomes. A small number of articles reported using other methods such as online compensation (n = 3), or digital reminders for participants (n = 5). The majority of digital therapeutics clinical research using digital methods is conducted in the United States and increasing number of articles using digital methods are published each year. CONCLUSIONS Digital methods are used in clinical trial research evaluating DTx, though not frequently as evidenced by the low proportion of articles included in this review. Fully remote clinical trial research is not yet the standard, more frequently authors are using partially remote methods. Additionally, there is tremendous variability in the level of detail describing digital methods within the literature. As digital technologies continue to advance and the clinical research DTx literature matures, digital methods which facilitate remote research may be used more frequently.

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Rationalisations for women-only randomised controlled trials in conditions that affect both sexes: a scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2020-043370 ◽

2021 ◽

Vol 11 (2) ◽

pp. e043370

Author(s):

Ainsley Matthewson ◽

Olena Bereznyakova ◽

Brian Dewar ◽

Alexandra Davis ◽

Mark Fedyk ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Randomised Controlled Trials ◽

Standard Of Care ◽

Standards Of Care ◽

Controlled Trials ◽

Theory Approach ◽

Reference Centre ◽

Cochrane Database ◽

Randomised Controlled

IntroductionWomen have historically been under-represented in randomised controlled trials (RCTs), including many landmark RCTs that established standards of care. In light of this fact, some modern researchers are calling for replication of earlier landmark trials with women only. This approach is ethically concerning, in that it would require some enrolled women to be deprived of treatments that are currently considered standard of care.ObjectiveIn an attempt to better understand the justification of a women-only approach to designing clinical trials, this study looks to systematically categorise the number of women-only RCTs for conditions that affect both men and women and the reasons given within the medical and philosophical literatures to perform them.MethodologyThis scoping review of the literature will search, screen and select articles based on predetermined inclusion/exclusion criteria, after which a grounded theory approach will be used to synthesise the data. It is expected that there will be a variety of reasons given for why a women-only trial may be justified. Electronic databases that will be searched include MEDLINE, EMBASE, Cochrane Database of Systematic Reviews, Cochrane Clinical Trials Register, Web of Science Proceedings, ClinicalTrials.gov, Philosopher’s Index, Phil Papers, JSTOR, Periodicals Archive Online, Project MUSE and the National Reference Centre for Bioethics.SignificanceThe scope of this study is to determine published rationales used to justify women-only randomised trials, both in the case of new trials and in the repetition of landmark trials.Ethics and disseminationResearch ethics board approval is not required for this study as there is no participant involvement. Results will be published as a stand-alone manuscript and will inform a larger project related to the ethics of a women-only RCT of carotid intervention for women with symptomatic high-grade carotid stenosis.

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Assessments of Sensorimotor Deficits Used in Randomized Clinical Trials With Individuals With Ankle Sprains and Chronic Ankle Instability: A Scoping Review

PM&R ◽

10.1002/pmrj.12487 ◽

2020 ◽

Author(s):

Shojiro Nozu ◽

Masahiro Takemura ◽

Gisela Sole

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Randomized Clinical Trials ◽

Ankle Instability ◽

Chronic Ankle Instability ◽

Ankle Sprains ◽

Sensorimotor Deficits

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Sexual health and COVID-19: protocol for a scoping review

Systematic Reviews ◽

10.1186/s13643-021-01591-y ◽

2021 ◽

Vol 10 (1) ◽

Author(s):

Navin Kumar ◽

Kamila Janmohamed ◽

Kate Nyhan ◽

Laura Forastiere ◽

Wei-Hong Zhang ◽

...

Keyword(s):

Systematic Review ◽

Clinical Trials ◽

Sexual Health ◽

Scoping Review ◽

Current Knowledge ◽

Grey Literature ◽

Well Being ◽

World Health ◽

Original Research ◽

Scoping Reviews

Abstract Background Global responses to the COVID-19 pandemic have exposed and exacerbated existing socioeconomic and health inequities that disproportionately affect the sexual health and well-being of many populations, including people of color, ethnic minority groups, women, and sexual and gender minority populations. Although there have been several reviews published on COVID-19 and health disparities across various populations, none has focused on sexual health. We plan to conduct a scoping review that seeks to fill several of the gaps in the current knowledge of sexual health in the COVID-19 era. Methods A scoping review focusing on sexual health and COVID-19 will be conducted. We will search (from January 2020 onwards) CINAHL, Africa-Wide Information, Web of Science Core Collection, Embase, Gender Studies Database, Gender Watch, Global Health, WHO Global Literature on Coronavirus Disease Database, WHO Global Index Medicus, PsycINFO, MEDLINE, and Sociological Abstracts. Grey literature will be identified using Disaster Lit, Google Scholar, governmental websites, and clinical trials registries (e.g., ClinicalTrial.gov, World Health Organization, International Clinical Trials Registry Platform, and International Standard Randomized Controlled Trial Number Registry). Study selection will conform to the Joanna Briggs Institute Reviewers’ Manual 2015 Methodology for JBI Scoping Reviews. Only English language, original studies will be considered for inclusion. Two reviewers will independently screen all citations, full-text articles, and abstract data. A narrative summary of findings will be conducted. Data analysis will involve quantitative (e.g., frequencies) and qualitative (e.g., content and thematic analysis) methods. Discussion Original research is urgently needed to mitigate the risks of COVID-19 on sexual health. The planned scoping review will help to address this gap. Systematic review registrations Systematic Review Registration: Open Science Framework osf/io/PRX8E

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Dynamic methods for ongoing assessment of site-level risk in risk-based monitoring of clinical trials: a scoping review

10.1101/2020.04.01.20049627 ◽

2020 ◽

Author(s):

William J Cragg ◽

Caroline Hurley ◽

Victoria Yorke-Edwards ◽

Sally P Stenning

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Research Question ◽

Trial Data ◽

Monitoring Methods ◽

Central Monitoring ◽

Statistical Monitoring ◽

Site Monitoring ◽

Central Statistical ◽

Monitoring Activity

AbstractBackground/AimsIt is increasingly recognised that reliance on frequent site visits for monitoring clinical trials is inefficient. Regulators and trialists have in recent years encouraged more risk-based monitoring. Risk assessment should take place before a trial begins in order to define the overarching monitoring strategy. It can also be done on an ongoing basis, in order to target sites for monitoring activity. Various methods have been proposed for such prioritisation, often using terms like ‘central statistical monitoring’, ‘triggered monitoring’ or, as in ICH Good Clinical Practice guidance, ‘targeted on-site monitoring’. We conducted a scoping review to identify such methods, to establish if any published methods were supported by adequate evidence to allow wider implementation, and to point the way to future developments in this field of research.MethodsWe used 7 publication databases, 2 sets of methodological conference abstracts and an internet search engine to look for methods for using centrally held trial data to assess site conduct during a trial. We included only reports in English, and excluded reports published before 1996 and reports not directly relevant to our research question. We used reference and citation searches to find additional relevant reports. We extracted data using a pre- defined template. We contacted authors to request additional information about included reports and to check whether reports might be eligible.ResultsWe included 30 reports in our final dataset, of which 21 were peer-reviewed publications. 20 reports described central statistical monitoring methods (of which 7 focussed on detection of fraud or misconduct) and 9 described triggered monitoring methods. 21 reports included some assessment of their methods’ effectiveness. Most commonly this involved exploring the methods’ characteristics using real trial data with no known integrity issues. Of the 21 with some effectiveness assessment, most presented limited or no information about whether or not concerns identified through central monitoring constituted meaningful problems. Some reports commented on cost savings from reduced on-site monitoring, but none gave detailed costings for the development and maintenance of central monitoring methods themselves.ConclusionsOur review identified various proposed methods, some of which could be combined within the same trial. The apparent emphasis on fraud detection may not be proportionate in all trial settings. Although some methods have self-justifying benefits for data cleaning activity, many have limitations that may currently prevent their routine use for targeting trial monitoring activity. The implementation costs, or uncertainty about these, may also be a barrier. We make recommendations for how the evidence-base supporting these methods could be improved.

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Underrepresentation of Adults and Older Adults With Disabilities in Behavioral Clinical Trials: A Scoping Review

Innovation in Aging ◽

10.1093/geroni/igaa057.2215 ◽

2020 ◽

Vol 4 (Supplement_1) ◽

pp. 644-644

Author(s):

Susan Stark ◽

Marian Keglovits ◽

Sandra Espín Tello

Keyword(s):

Older Adults ◽

Clinical Trials ◽

Scoping Review ◽

People With Disabilities ◽

The United States ◽

Health Condition ◽

Research Strategies ◽

Behavioral Studies ◽

Behavioral Trials

Abstract A lack of evidence-based interventions for people aging with long-term physical disabilities exists. To examine the exclusion of people with disabilities in behavioral clinical trials, a scoping review was conducted. ClinicalTrials.gov was searched for interventional behavioral studies from the United States completed from 2008–2018, with results focused on adults (18–64) and older adults (65+). In total, 158 clinical trials were included. In 129 articles, health conditions were excluded 697 times. Seventy-one clinical trials excluded at least one health condition with strong justification, 11 with poor justification, and 115 without justification. There is strong evidence that people with disabilities are excluded from behavioral clinical trials, often without justification. To help close this gap, our presentation will discuss how translational research strategies, focused on adapting existing EB behavioral trials, can be used to increase the availability of interventions that address the needs of individuals aging with and into long-term disabilities. Part of a symposium sponsored by the Lifelong Disabilities Interest Group.

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Mapping the study topics and characteristics of HIV pre-exposure prophylaxis research literature: a protocol for a scoping review

BMJ Open ◽

10.1136/bmjopen-2018-024212 ◽

2019 ◽

Vol 9 (5) ◽

pp. e024212 ◽

Cited By ~ 1

Author(s):

Emiko Kamitani ◽

Adebukola H Johnson ◽

Megan Wichser ◽

Yuko Mizuno ◽

Julia B DeLuca ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

The United States ◽

Research Literature ◽

Population Characteristics ◽

Sexually Transmitted ◽

Research Areas ◽

Control And Prevention ◽

Study Characteristics ◽

Exposure Prophylaxis

IntroductionThe research literature addressing pre-exposure prophylaxis (PrEP) has increased considerably over the last decade. To better understand the research areas and explore research gaps, we will conduct a scoping review to map study topics and describe study characteristics and populations in publications focused on PrEP. The purpose of this protocol is to describe planned methods for the scoping review.Methods and analysisWe will implement a comprehensive systematic literature search to identify PrEP citations in the United States Centres for Disease Control and Prevention HIV/AIDS Prevention Research Synthesis Project database that is unique and extensively focuses on HIV/sexually transmitted infections/hepatitis. We will screen and include studies that are (1) focused on HIV PrEP, (2) primary research with human participants and (3) published in English. Two reviewers will independently abstract data on authors’ names, study years, countries, population characteristics and design. To describe and summarise study topics, we will use 19 codes and five categories that were developed from a preliminary study. The five categories arecategory 1: potential PrEP user/prescriber(behaviours/issues for potential PrEP takers/healthcare professionals),category 2: considerations while on PrEP(experiences of and problems related to staying on or prescribing PrEP),category 3: PrEP efficacy and safety(biomedical aspects and medication efficacy),category 4: methods of and experiences with PrEP clinical trials(possesses/experiences of clinical trials) andcategory 5: cost-effectiveness or economic evaluation(cost studies). Data will be analysed with descriptive statistics.Ethics and disseminationThe findings will be presented at HIV-related conferences and published in peer-review journals.

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A Scoping Review of Registered Clinical Trials of Convalescent Plasma for COVID-19 and a Framework for Accelerated Synthesis of Trial Evidence (FAST Evidence)

Transfusion Medicine Reviews ◽

10.1016/j.tmrv.2020.06.005 ◽

2020 ◽

Vol 34 (3) ◽

pp. 158-164 ◽

Cited By ~ 1

Author(s):

Katina Zheng ◽

Gary Liao ◽

Manoj M. Lalu ◽

Alan Tinmouth ◽

Dean A. Fergusson ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Trial Evidence

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Glucagon-like peptide-1 receptor agonists as neuroprotective agents for ischemic stroke: a systematic scoping review

Journal of Cerebral Blood Flow & Metabolism ◽

10.1177/0271678x20952011 ◽

2020 ◽

Vol 41 (1) ◽

pp. 14-30 ◽

Cited By ~ 1

Author(s):

Mark P Maskery ◽

Christian Holscher ◽

Stephanie P Jones ◽

Christopher I Price ◽

W David Strain ◽

...

Keyword(s):

Clinical Trials ◽

Ischemic Stroke ◽

Acute Ischemic Stroke ◽

Scoping Review ◽

Clinical Studies ◽

Neuroprotective Agents ◽

Receptor Agonists ◽

Glucagon Like Peptide ◽

Glucagon Like Peptide 1 ◽

Retrospective Database

Stroke mortality and morbidity is expected to rise. Despite considerable recent advances within acute ischemic stroke treatment, scope remains for development of widely applicable neuroprotective agents. Glucagon-like peptide-1 receptor agonists (GLP-1RAs), originally licensed for the management of Type 2 Diabetes Mellitus, have demonstrated pre-clinical neuroprotective efficacy in a range of neurodegenerative conditions. This systematic scoping review reports the pre-clinical basis of GLP-1RAs as neuroprotective agents in acute ischemic stroke and their translation into clinical trials. We included 35 pre-clinical studies, 11 retrospective database studies, 7 cardiovascular outcome trials and 4 prospective clinical studies. Pre-clinical neuroprotection was demonstrated in normoglycemic models when administration was delayed by up to 24 h following stroke induction. Outcomes included reduced infarct volume, apoptosis, oxidative stress and inflammation alongside increased neurogenesis, angiogenesis and cerebral blood flow. Improved neurological function and a trend towards increased survival were also reported. Cardiovascular outcomes trials reported a significant reduction in stroke incidence with semaglutide and dulaglutide. Retrospective database studies show a trend towards neuroprotection. Prospective interventional clinical trials are on-going, but initial indicators of safety and tolerability are favourable. Ultimately, we propose that repurposing GLP-1RAs is potentially advantageous but appropriately designed trials are needed to determine clinical efficacy and cost-effectiveness.

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Guidance for reporting outcomes in clinical trials: scoping review protocol

BMJ Open ◽

10.1136/bmjopen-2018-023001 ◽

2019 ◽

Vol 9 (2) ◽

pp. e023001 ◽

Cited By ~ 3

Author(s):

Nancy J Butcher ◽

Emma J Mew ◽

Leena Saeed ◽

Andrea Monsour ◽

Alyssandra Chee-a-tow ◽

...

Keyword(s):

Clinical Trials ◽

Scoping Review ◽

Grey Literature ◽

Reference List ◽

Evidence Based ◽

Outcome Reporting ◽

Trial Outcome ◽

Trial Protocols ◽

Review Protocol ◽

Electronic Bibliographic Database

IntroductionPatients, families and clinicians rely on published research to help inform treatment decisions. Without complete reporting of the outcomes studied, evidence-based clinical and policy decisions are limited and researchers cannot synthesise, replicate or build on existing research findings. To facilitate harmonised reporting of outcomes in published trial protocols and reports, the Instrument for reporting Planned Endpoints in Clinical Trials (InsPECT) is under development. As one of the initial steps in the development of InsPECT, a scoping review will identify and synthesise existing guidance on the reporting of trial outcomes.Methods and analysisWe will apply methods based on the Joanna Briggs Institute scoping review methods manual. Documents that provide explicit guidance on trial outcome reporting will be searched for using: (1) an electronic bibliographic database search; (2) a grey literature search; and (3) solicitation of colleagues for guidance documents using a snowballing approach. Reference list screening will be performed for included documents. Search results will be divided between two trained reviewers who will complete title and abstract screening, full-text screening and data charting. Captured trial outcome reporting guidance will be compared with candidate InsPECT items to support, refute or refine InsPECT content and to assess the need for the development of additional items. Data analysis will explore common features of guidance and use quantitative measures (eg, frequencies) to characterise guidance and its sources.Ethics and disseminationA paper describing the review findings will be published in a peer-reviewed journal. The results will be used to inform the InsPECT development process, helping to ensure that InsPECT provides an evidence-based tool for standardising trial outcome reporting.

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