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European Journal of Clinical... Nov 2019Poorly described placebo/sham controls make it difficult to appraise active intervention benefits and harms. The 12-item Template for Intervention Description and...
BACKGROUND
Poorly described placebo/sham controls make it difficult to appraise active intervention benefits and harms. The 12-item Template for Intervention Description and Replication (TIDieR) checklist was developed to improve the reporting of active interventions. The extent to which TIDieR has been used to improve description of placebo or sham control is not known.
MATERIALS AND METHODS
We systematically identified and examined all placebo/sham-controlled randomised trials published in 2018 in the top six general medical journals. We reported how many of the TIDieR checklist items were used to describe the placebo/sham control(s). We supplemented this with a sample of 100 placebo/sham-controlled trials from any journal and searched Google Scholar to identify placebo/sham-controlled trials citing TIDieR.
RESULTS
We identified 94 placebo/sham-controlled trials published in the top journals in 2018. None reported using TIDieR, and none reported placebo or sham components completely. On average eight TIDieR items were addressed, with placebo/sham control name (100%) and when and how much was administered (97.9%) most commonly reported. Some items (rationale, 8.5%, whether there were modifications, 25.5%) were less often reported. In our sample of less well-cited journals, reporting was poorer (average of six items) and followed a similar pattern. Since TIDieR's first publication, six placebo-controlled trials have cited it according to Google Scholar. Two of these used the checklist to describe placebo controls; neither one completely desribed the placebo intervention.
CONCLUSIONS
Placebo and sham controls are poorly described within randomised trials, and TIDieR is rarely used to guide these descriptions. We recommend developing guidelines to promote better descriptions of placebo/sham control components within clinical trials.
Topics: Checklist; Control Groups; Humans; Placebos; Randomized Controlled Trials as Topic; Research Report
PubMed: 31519047
DOI: 10.1111/eci.13169 -
Administration and Policy in Mental... Jan 2020Inadequate implementation strategy reporting restricts research synthesis and replicability. We explored the implementation strategy reporting quality of a sample of...
Inadequate implementation strategy reporting restricts research synthesis and replicability. We explored the implementation strategy reporting quality of a sample of mental health articles using Proctor et al.'s (Implement Sci 8:139, 2013) reporting recommendations. We conducted a narrative review to generate the sample of articles and assigned a reporting quality score to each article. The mean article reporting score was 54% (range 17-100%). The most reported domains were: name (100%), action (82%), target (80%), and actor (67%). The least reported domains included definition (6%), temporality (26%), justification (34%), and outcome (37%). We discuss limitations and provide recommendations to improve reporting.
Topics: Evidence-Based Practice; Health Plan Implementation; Humans; Implementation Science; Mental Health; Research
PubMed: 31482489
DOI: 10.1007/s10488-019-00965-8 -
CNS Drugs Aug 2020Refractory status epilepticus (RSE) represents a serious medical condition requiring early and targeted therapy. Given the increasing number of elderly or multimorbid... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Refractory status epilepticus (RSE) represents a serious medical condition requiring early and targeted therapy. Given the increasing number of elderly or multimorbid patients with a limitation of life-sustaining therapy (LOT) or within a palliative care setting (PCS), guidelines-oriented therapy escalation options for RSE have to be omitted frequently.
OBJECTIVES
This systematic review sought to summarize the evidence for fourth-line antiseizure drugs (ASDs) and other minimally or non-invasive therapeutic options beyond guideline recommendations in patients with RSE to elaborate on possible treatment options for patients undergoing LOT or in a PCS.
METHODS
A systematic review of the literature in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, focusing on fourth-line ASDs or other minimally or non-invasive therapeutic options was performed in February and June 2020 using the MEDLINE, EMBASE and Cochrane databases. The search terminology was constructed using the name of the specific ASD or therapy option and the term 'status epilepticus' with the use of Boolean operators, e.g. "(brivaracetam) AND (status epilepticus)". The respective Medical Subject Headings (MeSH) and Emtree terms were used, if available.
RESULTS
There is currently no level 1, grade A evidence for the use of ASDs in RSE. The best evidence was found for the use of lacosamide and topiramate (level 3, grade C), followed by brivaracetam, perampanel (each level 4, grade D) and stiripentol, oxcarbazepine and zonisamide (each level 5, grade D). Regarding non-medicinal options, there is little evidence for the use of the ketogenic diet (level 4, grade D) and magnesium sulfate (level 5, grade D) in RSE. The broad use of immunomodulatory or immunosuppressive treatment options in the absence of a presumed autoimmune etiology cannot be recommended; however, if an autoimmune etiology is assumed, steroid pulse, intravenous immunoglobulins and plasma exchange/plasmapheresis should be considered (level 4, grade D). Even if several studies suggested that the use of neurosteroids (level 5, grade D) is beneficial in RSE, the current data situation indicates that there is formal evidence against it.
CONCLUSIONS
RSE in patients undergoing LOT or in a PCS represents a challenge for modern clinicians and epileptologists. The evidence for the use of ASDs in RSE beyond that in current guidelines is low, but several effective and well-tolerated options are available that should be considered in this patient population. More so than in any other population, advance care planning, advance directives, and medical ethical aspects have to be considered carefully before and during therapy.
Topics: Anticonvulsants; Autoimmunity; Humans; Immunoglobulins, Intravenous; Palliative Care; Status Epilepticus
PubMed: 32705422
DOI: 10.1007/s40263-020-00747-z -
Heliyon Dec 2022The advancement of information and communication technologies has led to an increasing use of conversational chatbots in the learning and teaching sector, especially for...
The advancement of information and communication technologies has led to an increasing use of conversational chatbots in the learning and teaching sector, especially for the second language (L2) acquisition. In the field of second language acquisition, the use of AI chatbots has been explored, mainly studying pedagogical approaches. However, there is a limited study in the development of empathetic strategies for dealing with learners' emotional discomfort, the impact of humor and the consideration of learners' cultural backgrounds. Thus, this study reviews the existing studies on AI second language (L2) chatbots to investigate the development of empathetic strategies for enhancing learners' learning outcomes. To achieve the aim of this study, prior studies from 2012 and 2022 of several popular databases, including Web of Science, ProQuest, IEEE and ScienceDirect are collected and analyzed. This study found that three dimensions such as cultural, empathetic and humorous dimensions have a positive influence on the application of AI L2 chatbots for enhancing learners' learning outcomes. This study also found that the development of an AI chatbot in L2 education has plenty of room for improvement. Several recommendations are made for enhancing the use of AI L2 chatbots which include integrating cross-cultural empathetic responses in conversational L2 chatbots, identifying how learners perceive and react to the learning content, and investigating the effects of cross-culture humor on learners' language proficiency.
PubMed: 36531630
DOI: 10.1016/j.heliyon.2022.e12056 -
The Journal of Antimicrobial... Aug 2020To summarize studies on prescribing medicine to general outpatients through the WHO/International Network for Rational Use of Drugs (INRUD) prescribing indicators with a... (Meta-Analysis)
Meta-Analysis
Assessment of medicine use among outpatients at healthcare facilities in Ethiopia using the WHO's prescribing indicators with a focus on antibiotics: a systematic review and meta-analysis.
OBJECTIVES
To summarize studies on prescribing medicine to general outpatients through the WHO/International Network for Rational Use of Drugs (INRUD) prescribing indicators with a focus on antibiotic prescription.
METHODS
A systematic review and random-effects meta-analysis of studies on the WHO prescribing indicators with a focus on the percentage of encounters with antibiotics prescribed (PEAP) was performed. The databases PubMed, Web of Science, EMBASE and Global Index Medicus were searched.
RESULTS
Twenty-six studies with a total of over 34 000 prescription encounters were included in the systematic review, showing a mean of two medicines per encounter. In each meta-analysis, a range of 19 to 25 studies was included. The percentages of medicines prescribed with an international non-proprietary name (INN) and from the essential medicines list (EML) were 91% and 96% of the total number of medicines, respectively, while 19% of encounters contained injections. Studies with over 25 000 prescription encounters reported an average PEAP of 58% and PEAP showed an increasing trend over the years included in this review. Multivariable meta-regression showed that PEAP increased with the average number of medicines per encounter (estimate = 0.83, P value = 0.0005). The number of medicines, study design and year of prescription explained over 40% of the variation in PEAP across studies.
CONCLUSIONS
Patterns of medicine use within and close to the WHO reference values were reported for the number of medicines, INN prescribing, prescription of injections and compliance with the EML, on average. Prescription of antibiotics requires attention as amounts much higher than the reference values were prescribed, which were even higher with polypharmacy and increasing over the years included in this review.
Topics: Anti-Bacterial Agents; Cross-Sectional Studies; Drug Prescriptions; Ethiopia; Humans; Outpatients; Practice Patterns, Physicians'; World Health Organization
PubMed: 32437516
DOI: 10.1093/jac/dkaa124 -
Journal of Clinical and Experimental... Apr 2024Semantic verbal fluency (SVF) is a widely used measure of frontal executive function and access to semantic memory. SVF scoring metrics include the number of unique... (Review)
Review
INTRODUCTION
Semantic verbal fluency (SVF) is a widely used measure of frontal executive function and access to semantic memory. SVF scoring metrics include the number of unique words generated, perseverations, intrusions, semantic cluster size and switching between clusters, and scores vary depending on the language the test is administered in. In this paper, we review the existing normative data for Turkish, the main metrics used for scoring SVF data in Turkish, and the most frequently used categories.
METHOD
We conducted a systematic review of peer-reviewed papers using Medline, EMBASE, PsycInfo, Web of Science, and two Turkish databases, TR-Dizin and Yok-Tez. Included papers contained data on the SVF performance of healthy adult native speakers of Turkish, and reported the categories used. Versions of the SVF that required participants to alternate categories were excluded. We extracted and tabulated demographics, descriptions of groups, metrics used, categories used, and sources of normative data. Studies were assessed for level of detail in reporting findings.
RESULTS
1400 studies were retrieved. After deduplication, abstract, full text screening, and merging of theses with their published versions, 121 studies were included. 114 studies used the semantic category "animal", followed by first names ( = 14, 12%). All studies reported word count. More complex measures were rare (perseverations: = 12, 10%, clustering and switching: = 5, 4%). Four of seven normative studies reported only word count, two also measured perseverations, and one reported category violations and perseverations. Two normative studies were published in English.
CONCLUSIONS
There is a lack of normative Turkish SVF data with more complex metrics, such as clustering and switching, and a lack of normative data published in English. Given the size of the Turkish diaspora, normative SVF data should include monolingual and bilingual speakers. Limitations include a restriction to key English and Turkish databases.
Topics: Humans; Semantics; Turkey; Neuropsychological Tests; Verbal Behavior; Reference Values; Adult; Female; Male; Executive Function
PubMed: 38904178
DOI: 10.1080/13803395.2024.2331827 -
Addictive Behaviors Sep 2019We conducted a systematic review of the literature on cigar research on youth to identify potential future research agenda to generate evidence to inform cigar...
INTRODUCTION
We conducted a systematic review of the literature on cigar research on youth to identify potential future research agenda to generate evidence to inform cigar regulations to prevent cigar use among youth.
METHODS
We searched articles on Medline, EMBASE, and PsycINFO in April 2017 to identify articles relevant to cigars and adolescents. Two independent coders examined 48 articles to determine eligibility: (1) published between 2000-April 2017; (2) published in English; (3) conducted in the United States; (4) published in a peer-review journal; (5) examined cigars, cigarillos, or little cigars; (6) included youth (12-18 years old); and (7) included empirical data. Three independent coders reviewed the included articles (n = 48) to identify whether the studies addressed FDA's Research Priorities.
RESULTS
The studies addressed FDA's Research Priorities of "behavior" (n = 48), "communications" (n = 4), "marketing influences" (n = 1), and "impact analysis" (n = 1). Studies on "behavior" underscored the need for improvements in measurement, such as using brand names and distinguishing cigar products. The review revealed the need for restrictions on cigar flavors, development of media campaigns and interventions, increasing the cost (via taxation), and evaluating the impact of cigar policies.
CONCLUSIONS
The studies mostly focused on surveillance of behaviors and use patterns, which revealed cigar specific issues to address in policies to decrease cigar use among youth. The lack of studies addressing other FDA's research priorities highlighted the critical need for future studies that inform prevention of youth cigar use.
Topics: Adolescent; Adolescent Behavior; Cigar Smoking; Communication; Humans; Marketing; Public Policy; Research; Smoking Cessation; Smoking Prevention; Tobacco Products; United States; United States Food and Drug Administration
PubMed: 31125939
DOI: 10.1016/j.addbeh.2019.04.032 -
Archives of Physical Medicine and... Aug 2021To evaluate the quality of descriptions of interventions in health care research reports, based on a synthesis of reviews that used the Template for Intervention...
OBJECTIVE
To evaluate the quality of descriptions of interventions in health care research reports, based on a synthesis of reviews that used the Template for Intervention Description and Replication (TIDieR) to rate the completeness and quality of intervention reporting.
DESIGN
Overview of published reviews. In a systematic search of the literature, 56 review articles were retrieved that had evaluated 3454 primary studies (index articles) using all or most of the 12 TIDieR items, applied to experimental treatment only or treatment and comparator both, separately. If available, percentages "reported completely" were extracted based on the index article, the index article supplemented by related information, and these 2 supplemented by e-mailing the author. Information on the review's methodology was also extracted.
SETTING
Not applicable.
PARTICIPANTS
Not applicable.
INTERVENTIONS
Not applicable.
MAIN OUTCOME MEASURES
Percentage of primary studies receiving "adequately reported" ratings on each of the 12 TIDieR items.
RESULTS
While for treatment arms TIDieR items 1 (name of treatment) and 2 (why of treatment) are generally judged to be reported adequately, the percentage is between 25% and 75% for most other items and is as low as 10% for item 10 (modifications). Comparators are reported even more poorly. Use of additional publications on a trial increased percentages "reported adequately" marginally; e-mailing resulted in significant increases in completeness of reporting. Rehabilitation trials were reported better than nonrehabilitation trials for some TIDieR items and worse for others.
CONCLUSIONS
Reporting on the interventions and comparators of trials is substandard. More extensive use of supplemental digital content and of versions of TIDieR customized for specific domains of research may improve the situation.
Topics: Biomedical Research; Clinical Trials as Topic; Guideline Adherence; Humans; Research Design; Research Report
PubMed: 33245937
DOI: 10.1016/j.apmr.2020.09.397 -
Environmental Science and Pollution... May 2021Advanced oxidation processes (AOPs) constitute a developing area of particular interest for researchers in different fields due to their broad range of applications....
Advanced oxidation processes (AOPs) constitute a developing area of particular interest for researchers in different fields due to their broad range of applications. However, there are few studies dedicated to the bibliometric analysis of AOPs. Hence, a systematic literature review of research publications (research articles, review articles, and book chapters) from 1980 to 2018 was carried out to visualize and evaluate research trends on AOPs around the world and, especially in Ibero-America (IA), on the field of wastewater treatment. Using the most extensive databases in literature search, Scopus and Web of Science (WoS), which encompass 95% of the publications in the world, a total of 18,751 records were retrieved by limiting the search results to words associated with AOPs in the titles, keyword, and abstracts. Raw data were manually organized and filtered, standardizing authors and institution names, publication titles, and keywords for the purpose of eliminating double-counted entries. Similarly, homonymous authors and institutions were identified for all records retrieved. The bibliometric dataset was processed using the VantagePoint software. The research trends visualized about AOPs were as follows: number of publications per triennium, publications by country, participation by continent, most important journals and authors, most referenced institutions, global network of co-authors, and keywords network visualization, highlighting the Ibero-American contribution to global research.
Topics: Bibliometrics; Databases, Factual; Oxidation-Reduction; United States; Wastewater
PubMed: 33140298
DOI: 10.1007/s11356-020-11333-7 -
Journal of Clinical Epidemiology Oct 2020The objective is to identify studies that have assessed methodological shortcuts for undertaking rapid reviews (RRs) and mapping these to review conduct stages and... (Comparative Study)
Comparative Study
OBJECTIVES
The objective is to identify studies that have assessed methodological shortcuts for undertaking rapid reviews (RRs) and mapping these to review conduct stages and Methodological Expectations of Cochrane Intervention Reviews (MECIR) guidance.
STUDY DESIGN AND SETTING
We conducted a systematic scoping review. We searched multiple databases (e.g., MEDLINE, Embase), which were supplemented by grey literature searching. Methods were defined a priori in a published protocol.
RESULTS
Out of 1,873 records, 90 publications were divided into four RR categories: formal evaluation (n = 14), development, which included four subcategories (n = 65), comparison (n = 2), and applying reporting guidelines/critical appraisal tools (n = 3), and a systematic review surrogate category (n = 6). Four formal evaluation studies were composite evaluations, including more than one shortcut simultaneously. The remaining 10 studies evaluated viable (e.g., including English-only publications) and unviable (e.g., single-reviewer screening) shortcuts, covering five key dimensions and five 'other' (e.g., involving stakeholders) considerations while conducting a review. Because of complexities around shortcuts evaluated, only a cursory mapping to MECIR criteria was possible.
CONCLUSION
Some methods shortcuts may be valid in the context of RRs, but limitations in the studies may limit their applicability. The results will serve to inform discussions within Cochrane regarding possible future implementation of RRs.
Topics: Abbreviations as Topic; Australia; Canada; Databases, Bibliographic; Databases, Factual; Guidelines as Topic; Humans; MEDLINE; Publications; Research Design; Review Literature as Topic; United Kingdom
PubMed: 32599023
DOI: 10.1016/j.jclinepi.2020.06.027