Veena S Singaram, Rayishnee Pillay, Esther L Mbobnda Kapche
{"title":"Exploring the role of digital technology for feedback exchange in clinical training: a scoping review.","authors":"Veena S Singaram, Rayishnee Pillay, Esther L Mbobnda Kapche","doi":"10.1186/s13643-024-02705-y","DOIUrl":"10.1186/s13643-024-02705-y","url":null,"abstract":"<p><strong>Background: </strong>Feedback plays an integral role in clinical training and can profoundly impact students' motivation and academic progression. The shift to online teaching, accelerated by the COVID-19 pandemic, highlighted the necessity of transitioning traditional feedback mechanisms to digital platforms. Despite this, there is still a lack of clarity regarding effective strategies and tools for delivering digital feedback in clinical education. This scoping review aimed to assess the current utilization of digital feedback methods in clinical education, with a focus on identifying potential directions for future research and innovation.</p><p><strong>Methods: </strong>A database search using a published protocol based on the Joanna Briggs Institute framework was conducted between January 2010 and December 2023. Six databases were searched, PubMed/MEDLINE, EBSCOhost, Scopus, Google Scholar, Union Catalogue of Theses and Dissertations, and WorldCat Dissertations and Theses. Reviewers independently screened the papers against eligibility criteria and discussed the papers to attain consensus. Extracted data were analyzed qualitatively and descriptively.</p><p><strong>Results: </strong>Of the 2412 records identified, 33 reports met the inclusion criteria. Digital tools explored for feedback included web-based and social sites, smart device applications, virtual learning environments, virtual reality, and artificial intelligence. Convenience and immediate, personalized feedback and enhanced formative assessment outcomes were major facilitators of digital feedback utility. Technical constraints, limited content development, training, and data security issues hindered the adoption of these tools. Reports mostly comprised empirical research, published in the global North and conducted on undergraduates studying medicine.</p><p><strong>Conclusion: </strong>This review highlighted a geographical imbalance in research on feedback exchange via digital tools for clinical training and stressed the need for increased studies in the global South. Furthermore, there is a call for broader exploration across other health professions and postgraduate education. Additionally, student perceptions of digital tools as intrusive necessitate a balanced integration with traditional feedback dialogues. The incorporation of virtual reality and artificial intelligence presents promising opportunities for personalized, real-time feedback, but requires vigilant governance to ensure data integrity and privacy. SCOPING REVIEW PROTOCOL: https://doi.org/10.1186/s13643-022-02151-8.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"298"},"PeriodicalIF":6.3,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11616237/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142781034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Johanne Hermann Karlsen, Kirstine Hermann Jørgensen, Ulla Møller Weinreich
{"title":"Association between impairment of lung function and risk of anxiety and depression in patients with chronic obstructive pulmonary disease-a systematic review.","authors":"Johanne Hermann Karlsen, Kirstine Hermann Jørgensen, Ulla Møller Weinreich","doi":"10.1186/s13643-024-02720-z","DOIUrl":"10.1186/s13643-024-02720-z","url":null,"abstract":"<p><strong>Background: </strong>This systematic review aims to examine the association between impairment of lung function and risk of anxiety and depression, respectively, in patients with chronic obstructive pulmonary disease (COPD).</p><p><strong>Methods: </strong>Literature search were performed 29/01-2024 using Embase and PubMed. Publications reporting association between forced expiratory volume in one second in percentage of expected value (FEV1(%)) and either anxiety or depression or both in patients with COPD were included. The studies were quality assessed using the Newcastle Ottawa Scale. The studies were analysed by assessing whether they showed significant results or not, and if they showed a negative or positive association between lung function and risk anxiety or depression and a pooled analysis was conducted.</p><p><strong>Results: </strong>Thirty-seven studies were included in the review, 15 reported anxiety and 31 reported depression, with 9 reporting both outcomes. Most were observational studies. Study population sizes ranged from 40 to 2147 patients. Three studies found a significant negative association between anxiety and FEV1(%), while five studies found a positive non-significant association between anxiety and FEV1(%). Fifteen studies found a significant negative association between FEV1(%) and depression. Especially the studies with larger study population sizes showed significant results. The pooled analysis supported this, as the depression studies showed a significant association between depression and FEV1(%), while the anxiety studies showed part non-significant, part significant associations between anxiety and FEV1(%).</p><p><strong>Conclusion: </strong>This systematic review did not support an association between anxiety and impairment of pulmonary function as only 3/15 studies showed significant negative associations, and some studies showed positive associations. This review indicated an association between depression and impairment pulmonary function in patients with COPD, as most studies with a larger study population size showed a significant negative association. Sytematic review registration. PROSPERO 2024 CRD42024506065 Available from: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024506065.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"300"},"PeriodicalIF":6.3,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11616382/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142781026","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Hussein Al-Qarni, Sabine M Allida, Julee McDonagh, Caleb Ferguson
{"title":"Barriers and facilitators to using feedback from clinical quality registries: a scoping review protocol.","authors":"Hussein Al-Qarni, Sabine M Allida, Julee McDonagh, Caleb Ferguson","doi":"10.1186/s13643-024-02693-z","DOIUrl":"10.1186/s13643-024-02693-z","url":null,"abstract":"<p><strong>Background: </strong>A clinical quality registry (CQR) is a structured database that systematically collects data to monitor clinical quality and improve healthcare outcomes. The aims of CQRs are to improve treatment plans, assist in decision-making, increase healthcare value, enhance care quality, and reduce healthcare costs by providing feedback to healthcare providers. Feedback to clinicians is used as a quality improvement tool. It provides data to clinicians about their performance, which may contribute to improvement in healthcare outcomes. To the best of our knowledge, previous research on CQRs has primarily focused on factors affecting their use and their impact on healthcare outcomes. In this study, a scoping review is conducted to understand the barriers to and facilitators of using feedback systems from clinical quality registries in acute healthcare settings.</p><p><strong>Methods: </strong>For this review, Arksey and O'Malley's framework for scoping reviews will be applied. The following electronic databases (MEDLINE via Ovid, CINAHL, and Scopus) and grey literature (Google Scholar) will be systematically searched for qualitative and mixed-method studies (only including qualitative findings) published after 2000 in the English language. Two reviewers will independently screen the articles and extract the data which, subsequently, will be mapped against the COM-B model.</p><p><strong>Discussion: </strong>This review is conducted with the aim of providing valuable insights into the factors that influence the utilisation of feedback from Clinical Quality Registries by healthcare providers, which, in the context of quality improvement, may have significant implications for clinical research, registry science, health policy, and clinical practice.</p><p><strong>Scoping review registration: </strong>This protocol has been registered prospectively with the Open Science Framework (OSF) ( https://osf.io/fhm4n/ ).</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"301"},"PeriodicalIF":6.3,"publicationDate":"2024-12-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11616109/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142781029","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Barriers and facilitators of benzathine penicillin G adherence among rheumatic heart disease patients: a mixed methods systematic review using the COM-B (capability, opportunity, and motivation for behavior) model.","authors":"Habtamu Abera Areri, Henok Tadele, Sale Workneh","doi":"10.1186/s13643-024-02691-1","DOIUrl":"10.1186/s13643-024-02691-1","url":null,"abstract":"<p><strong>Background: </strong>Benzathine penicillin G (BPG) is a proven preventive agent for preventing the progression of rheumatic heart disease (RHD) and is recognized as a standard of care. However, ensuring adherence to BPG remains a global challenge. The objective of this review was to synthesize the available evidence on the barriers to and facilitators of BPG adherence among RHD patients.</p><p><strong>Methods: </strong>This systematic review included both qualitative and quantitative studies on RHD patients published in the English language. This systematic review was conducted following the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) guidelines. The search strategy involved PubMed, Embase, CINAHL, Global Health, Scopus, and Web of Sciences databases to identify keywords and terms contained in the title and abstract and the index terms used to describe articles. The review included papers published from January 1, 2000, to March 30, 2024. Two independent reviewers screened, appraised, and extracted the data. The data analysis was carried out deductively to fit onto the components of the COM-B (Capability, Opportunity, Motivation-Behaviour) model.</p><p><strong>Results: </strong>In this review, 1067 records were screened, and 22 studies with 7338 participants were included. Thirty-five barriers and twenty facilitators were identified and mapped onto COM-B components. Physical capability (e.g., felt healthy), psychological capability (e.g., lack of knowledge), reflective motivation (e.g., poor patient handling), automatic motivation (e.g., BPG injection pain), physical opportunity (e.g., BPG unavailability) and social opportunity (e.g., inadequate counseling) were identified as barriers. The most discussed barrier was automatic motivation, followed by psychological capability and physical opportunity.</p><p><strong>Conclusions: </strong>Our review revealed variable levels of BPG adherence across studies and identified significant barriers and facilitators. Further research is recommended to identify contextual interventions to address barriers and capitalize on facilitators.</p><p><strong>Systematic review registration: </strong>PROSPERO CRD42024535398.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"297"},"PeriodicalIF":6.3,"publicationDate":"2024-12-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11613468/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142772502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"Spinal manipulations for migraine: an updated systematic review and meta-analysis of randomized clinical trials.","authors":"Pawel Posadzki, Andrzej T Klimek, Edzard Ernst","doi":"10.1186/s13643-024-02719-6","DOIUrl":"10.1186/s13643-024-02719-6","url":null,"abstract":"<p><strong>Objective: </strong>This update of a systematic review evaluates the effectiveness of spinal manipulations as a treatment for migraine headaches.</p><p><strong>Background: </strong>Spinal manipulation therapy (SMT) is sometimes used to treat migraine headaches; however, the biological plausibility and safety of SMT have repeatedly been questioned.</p><p><strong>Methods: </strong>Amed, Embase, MEDLINE, CINAHL, Mantis, Index to Chiropractic Literature, and Cochrane Central were searched from inception to September 2023. Randomized clinical trials (RCTs) investigating spinal manipulations (performed by various healthcare professionals including physiotherapists, osteopaths, and chiropractors) for treating migraine headaches in human subjects were considered. Other types of manipulative therapy, i.e., cranial, visceral, and soft tissue were excluded. The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) approach was used to evaluate the certainty of evidence.</p><p><strong>Results: </strong>Three more RCTs were published since our first review; amounting to a total of 6 studies with 645 migraineurs meeting the inclusion criteria. Meta-analysis of six trials showed that, compared with various controls (placebo, drug therapy, usual care), SMT (with or without usual care) has no effect on migraine intensity/severity measured with a range of instruments (standardized mean difference [SMD] - 0.22, 95% confidence intervals [CI] - 0.65 to 0.21, very low certainty evidence), migraine duration (SMD - 0.10; 95% CI - 0.33 to 0.12, 4 trials, low certainty evidence), or emotional quality of life (SMD - 14.47; 95% CI - 31.59 to 2.66, 2 trials, low certainty evidence) at post-intervention. A meta-analysis of two trials showed that compared with various controls, SMT (with or without usual care) increased the risk of AEs (risk ratio [RR] 2.06; 95% CI 1.24 to 3.41, numbers needed to harm = 6; very low certainty evidence). The main reasons for downgrading the evidence were study limitations (studies judged to be at an unclear or high risk of bias), inconsistency (for pain intensity/severity), imprecision (small sizes and wide confidence intervals around effect estimates) and indirectness (methodological and clinical heterogeneity of populations, interventions, and comparators).</p><p><strong>Conclusions: </strong>The effectiveness of SMT for the treatment of migraines remains unproven. Future, larger, more rigorous, and independently conducted studies might reduce the existing uncertainties.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"296"},"PeriodicalIF":6.3,"publicationDate":"2024-11-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11606176/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142755694","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
{"title":"End-of-life care for people with chronic obstructive pulmonary disease: a scoping review protocol.","authors":"Kotoko Minami, Chihiro Unozawa, Arina Matsunaga, Tomoko Kamei","doi":"10.1186/s13643-024-02712-z","DOIUrl":"10.1186/s13643-024-02712-z","url":null,"abstract":"<p><strong>Background: </strong>Chronic obstructive pulmonary disease (COPD) is a progressive inflammatory disease that has a typical illness trajectory. Awareness of unique disease courses as well as providing end-of-life care (EOLC) for COPD patients is important as most patients experience varied degrees of suffering toward the end-of-life. The purpose of this scoping review is to map out key concepts, main sources, and types of evidence available in the area of research on EOLC with multiple interventions for people with COPD.</p><p><strong>Methods: </strong>This scoping review will be conducted following the latest Joanna Briggs Institute (JBI) guidelines. In addition, this review process will adhere to the preferred reporting items for systematic reviews and meta-analysis extension for scoping reviews (PRISMA-ScR). The initial simple search concepts will be set out as \"chronic obstructive pulmonary disease\" and \"end-of-life care\". Based on the eligibility criteria, Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, CINAHL Ultimate, Embase, and Google Scholar databases will be searched, and all quantitative and qualitative studies of the after-year publication of each electronic database will be included. This process of literature selection will be carried out independently by each researcher. The results will be summarised in a narrative synthesis approach and the gaps and potential biases of the evidence identified by comparing the adopted articles for EOLC with multiple interventions for people with COPD.</p><p><strong>Discussion: </strong>This scoping review will outline in detail the evidence and the gaps from primary studies that have been gathered from the qualitative and quantitative literature based on all eligibility criteria. Therefore, the results of this review will contribute to a new field of systematic reviews. Furthermore, providing an outline of an EOLC for COPD in this study may improve the practice of healthcare professionals in this area. Ethical approval and consent are not required as no human participants were involved in this study.</p><p><strong>Systematic review registration: </strong>This research has been registered in the Open Science Framework (OSF) ( https://osf.io/upd4a ).</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"294"},"PeriodicalIF":6.3,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603901/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751206","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Ane Goñi-Arana, Jorge Pérez-Martín, Francisco Javier Díez
{"title":"Breast thermography: a systematic review and meta-analysis.","authors":"Ane Goñi-Arana, Jorge Pérez-Martín, Francisco Javier Díez","doi":"10.1186/s13643-024-02708-9","DOIUrl":"10.1186/s13643-024-02708-9","url":null,"abstract":"<p><strong>Background: </strong>Breast thermography originated in the 1950s but was later abandoned due to the contradictory results obtained in the following decades. However, advances in infrared technology and image processing algorithms in the twenty-first century led to a renewed interest in thermography. This work aims to provide an updated and objective picture of the recent scientific evidence on its effectiveness, both as a screening and as a diagnostic tool.</p><p><strong>Methods: </strong>We searched for clinical studies published between 2001 and May 31, 2023, in the databases PubMed and Scopus, that aimed to evaluate the effectiveness of digital, long-wave infrared imaging for detecting breast cancer. Additional documents were retrieved from the studies included in the systematic reviews that resulted from the search and by searching for the names of commercial systems. We limited our selection to studies that reported the sensitivity and specificity of breast thermography (or the data needed to calculate them) using images collected by themselves, with at least five breast cancer cases. Studies that considered breast diseases other than cancer to be positive or that did not use standard tests to set the ground truth diagnosis were excluded, as well as articles written in a language other than English and documents we could not access. We also conducted meta-analyses of proportions of the sensitivity and specificity values reported in the selected studies and a bivariate meta-analysis to account for the correlation between these metrics.</p><p><strong>Results: </strong>Our systematic search resulted in 22 studies, with an average pooled sensitivity and specificity of 88.5% and 71.8%, respectively. However, the differences in patient recruitment, sample size, imaging protocol, equipment, and interpretation criteria yielded a high heterogeneity measure (79.3% and 99.1% <math> <msup><mrow><mi>I</mi></mrow> <mn>2</mn></msup> </math> value, respectively).</p><p><strong>Conclusions: </strong>Overall, thermography showed a high sensitivity in the selected studies, whereas specificity started off lower and increased over time. The most recent studies reported a combination of sensitivity and specificity comparable to standard diagnostic tests. Most of the selected studies were small and tend to include only patients with a suspicious mass that requires biopsy. However, larger studies with a wider variety of patient types (asymptomatic, women with dense breasts, etc.) have been published in the latest years.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"295"},"PeriodicalIF":6.3,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603657/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751256","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Anne Alarilla, Katharine Terrell, Paula Kelly, Heather Chesters, Faith Gibson, Geralyn Oldham, Debbie Sell, Gwyneth Davies, Jo Wray
{"title":"Routine use of patient-reported experience and outcome measures for children and young people: a scoping review.","authors":"Anne Alarilla, Katharine Terrell, Paula Kelly, Heather Chesters, Faith Gibson, Geralyn Oldham, Debbie Sell, Gwyneth Davies, Jo Wray","doi":"10.1186/s13643-024-02706-x","DOIUrl":"10.1186/s13643-024-02706-x","url":null,"abstract":"<p><strong>Background: </strong>Patient-reported outcome measures (PROMs) measure people's views of their health status whereas patient-reported experience measures (PREMs) are questionnaires measuring perceptions of their experience whilst receiving healthcare. PROMs/PREMs have the potential to enable children and young people (CYP) to be involved in decisions about their care and improve the quality of their care but it is not clear how often PROMs/PREMs are incorporated as part of standard care of CYP in the hospital setting. The aims of this scoping review were to understand the extent of the literature and map available evidence on the use, benefits, barriers and facilitators of PROMs/PREMs as part of standard care and treatment of CYP in hospitals.</p><p><strong>Methods: </strong>The Joanna Briggs Institute review process was used to map existing evidence on the use of PROMs/PREMs in routine care of CYP in different hospital settings worldwide. Key search terms were developed and Ovid (Emcare, Embase MEDLINE, APA PsychInfo), Scopus and Web of Science were searched. Data were analysed using frequency counts and basic content analysis for thematic mapping according to the research questions. We undertook an initial search in February 2021 and updated this in April 2023.</p><p><strong>Results: </strong>The search yielded 68,004 studies, 388 were eligible for full text review and 172 met the inclusion criteria. PROMs were more commonly used than PREMs in routine care of CYP in hospitals; these were mostly collected using electronic collection and concentrated in specific specialities, settings, contexts and countries. The findings mapped the use of PROMs/PREMs, including how data are applied in clinical practice and used for service development, but this was not consistently reported. There are specific challenges in the implementation of PROMs/PREMs in routine care of CYP that need to be considered.</p><p><strong>Conclusion: </strong>PROMs/PREMs have the potential to improve care for CYP in hospital settings contributing to different aspects of care. A better understanding of their use, how results can be applied in clinical practice and contribute to service development will enable meaningful employment. The popularity of electronically collected and captured PROMS/PREMs warrants further investigation to enable their meaningful use in routine care of CYP.</p><p><strong>Systematic review registration: </strong>Not pre-registered.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"293"},"PeriodicalIF":6.3,"publicationDate":"2024-11-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11603634/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142751207","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Aurélio Matos Andrade, Juliana da Motta Girardi, Erica Tatiane da Silva, Jakeline Ribeiro Barbosa, Daniella Cristina Rodrigues Pereira
{"title":"Efficacy, safety, and immunogenicity of biosimilars compared with the biologic etanercept in patients with rheumatoid arthritis: a systematic review and meta-analysis.","authors":"Aurélio Matos Andrade, Juliana da Motta Girardi, Erica Tatiane da Silva, Jakeline Ribeiro Barbosa, Daniella Cristina Rodrigues Pereira","doi":"10.1186/s13643-024-02715-w","DOIUrl":"10.1186/s13643-024-02715-w","url":null,"abstract":"<p><strong>Background: </strong>Biosimilar etanercept presents itself as an innovative therapeutic opportunity for inflammatory and autoimmune diseases, however, its efficacy, safety, and immunogenicity in relation to the reference biological agent for the treatment of rheumatoid arthritis is still questioned. With this in mind, this study aimed to verify the efficacy, safety, and immunogenicity of the use of the biosimilar etanercept in relation to the reference biologic in patients over 18 years of age with rheumatoid arthritis.</p><p><strong>Methods: </strong>A systematic review with meta-analysis was performed in accordance with the parameters of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) selecting only Phase III randomized clinical trials. The search strategy was constructed with the MeSH terms \"Etanercept\", \"Biological Products\", \"Arthritis, Rheumatoid\", \"Biosimilar Pharmaceuticals\" and was performed in Medline via PubMed, Embase, the Cochrane Library, Web of Science, EBSCO and Lilacs in January 2023. The analysis measures were relative risk (RR) for dichotomous data and mean difference (MD) for continuous data. The statistical analysis for preparing meta-analyses was developed by the Review Manager 5.1.4 software.</p><p><strong>Results: </strong>This systematic review selected 6 eligible studies with a sample population of n = 2355. The main efficacy outcomes showed that both drugs did not present statistically significant differences in ACR20, ACR50, and ACR70 responses within 6 months (RR 1.00; 95% CI = 0.94 to 1.07; RR 1.09; 95% CI = 0.94 to 1.26; RR 1.04; 95% CI = 0.82 to 1.31, respectively), with I<sup>2</sup> ranging from 55 to 63% and 0.04 ≤ P ≥ 0.08. Adverse events were mostly mild or moderate, and serious adverse events were not statistically significant. Regarding immunogenicity, only 5.4% of the ADA-positive biosimilar group had positive neutralizing antibodies.</p><p><strong>Conclusions: </strong>Thus, this review found that biosimilar etanercept had efficacy, safety, and immunogenicity similar to those for the biological reference.</p><p><strong>Systematic review registration: </strong>This systematic review was registered on the PROSPERO platform under number CRD42020166610.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"291"},"PeriodicalIF":6.3,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11600673/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142740519","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Annette M O'Connor, Justin Clark, James Thomas, René Spijker, Wojciech Kusa, Vickie R Walker, Melissa Bond
{"title":"Large language models, updates, and evaluation of automation tools for systematic reviews: a summary of significant discussions at the eighth meeting of the International Collaboration for the Automation of Systematic Reviews (ICASR).","authors":"Annette M O'Connor, Justin Clark, James Thomas, René Spijker, Wojciech Kusa, Vickie R Walker, Melissa Bond","doi":"10.1186/s13643-024-02666-2","DOIUrl":"10.1186/s13643-024-02666-2","url":null,"abstract":"<p><p>The eighth meeting of the International Collaboration for the Automation of Systematic Reviews (ICASR) was held on September 7 and 8, 2023, at the University College London, London, England. ICASR is an interdisciplinary group whose goal is to maximize the use of technology for conducting rapid, accurate, and efficient evidence synthesis, e.g., systematic reviews, evidence maps, and scoping reviews of scientific evidence. In 2023, the major themes discussed were understanding the benefits and harms of automation tools that have become available in recent years, the advantages and disadvantages of large language models in evidence synthesis, and approaches to ensuring the validity of tools for the proposed task.</p>","PeriodicalId":22162,"journal":{"name":"Systematic Reviews","volume":"13 1","pages":"290"},"PeriodicalIF":6.3,"publicationDate":"2024-11-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11600926/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"142740525","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}