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Assessing the Risk of Bias in Randomized Clinical Trials With Large Language Models
Importance Large language models (LLMs) may facilitate the labor-intensive process of systematic reviews. However, the exact methods and reliability remain uncertain. Objective To explore the feasibility and reliability of using LLMs to assess risk of bias (ROB) in randomized clinical trials (RCTs). Design, Setting, and Participants A survey study was conducted between August 10, 2023, and October 30, 2023. Thirty RCTs were selected from published systematic reviews. Main Outcomes and Measures A structured prompt was developed to guide ChatGPT (LLM 1) and Claude (LLM 2) in assessing the ROB in these RCTs using a modified version of the Cochrane ROB tool developed by the CLARITY group at McMaster University. Each RCT was assessed twice by both models, and the results were documented. The results were compared with an assessment by 3 experts, which was considered a criterion standard. Correct assessment rates, sensitivity, specificity, and F1 scores were calculated to reflect accuracy, both overall and for each domain of the Cochrane ROB tool; consistent assessment rates and Cohen kappa were calculated to gauge consistency; and assessment time was calculated to measure efficiency. Performance between the 2 models was compared using risk differences. Results Both models demonstrated high correct assessment rates. LLM 1 reached a mean correct assessment rate of 84.5% (95% CI, 81.5%-87.3%), and LLM 2 reached a significantly higher rate of 89.5% (95% CI, 87.0%-91.8%). The risk difference between the 2 models was 0.05 (95% CI, 0.01-0.09). In most domains, domain-specific correct rates were around 80% to 90%; however, sensitivity below 0.80 was observed in domains 1 (random sequence generation), 2 (allocation concealment), and 6 (other concerns). Domains 4 (missing outcome data), 5 (selective outcome reporting), and 6 had F1 scores below 0.50. The consistent rates between the 2 assessments were 84.0% for LLM 1 and 87.3% for LLM 2. LLM 1's kappa exceeded 0.80 in 7 and LLM 2's in 8 domains. The mean (SD) time needed for assessment was 77 (16) seconds for LLM 1 and 53 (12) seconds for LLM 2. Conclusions In this survey study of applying LLMs for ROB assessment, LLM 1 and LLM 2 demonstrated substantial accuracy and consistency in evaluating RCTs, suggesting their potential as supportive tools in systematic review processes.
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Efficacy and safety of repetitive transcranial magnetic stimulation combined with antidepressants in children and adolescents with depression: A systematic review and meta-analysis
Objective: Non-invasive brain stimulation (NIBS) is beneficial to adult patients with depression, but its safety and efficacy in combination with antidepressants in children and adolescents with depression are not clear. We conducted a preliminary meta-analysis to objectively evaluate its clinical effect and provide information for future research and clinical practice. Methods: PubMed, Cochrane Library, Embase, and Web of Science were searched systematically to find clinical trials published in English before April 11, 2023. Stata software was used for meta-analysis, and random or fixed effect models were used to combine effect sizes. Results: Nine studies were eligible and included (n = 393). No articles about children were included in the analysis. The results showed that the remission rate was 40% (95% confidence interval [CI]: 13% to 71%). The scores of Children's Depression Rating Scale (CRDS) and Hamilton's depression scale (HAMD) significantly decreased compared to baseline value (MD = -27.04, 95% CI: -30.95, -23.12 and MD = -12.78, 95% CI: -19.55 to -6.01). In addition, the incidence of all adverse events was 13% (95% CI: 5%, 23%), and all were minor pain-related events. Conclusion: The combination of NIBS and antidepressants has been shown to notably alleviate depressive symptoms in adolescents, offering a considerable level of safety. This therapeutic synergy is particularly effective in patients with major depressive disorder, where repetitive transcranial magnetic stimulation augmented with antidepressants can enhance the amelioration of depressive symptoms. Systematic review registration: https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42023442215, PROSPERO CRD42023442215.
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CAR-T-cell therapies
Authors' objectives: The chimeric antigen receptor (CAR) T-cell therapies tisagenlecleucel (tisa-cel) and axicabtagene ciloleucel (axi-cel) are provisionally listed in Appendix 1 of the Health Insurance Benefits Ordinance in Switzerland until 31 December 2024 for the third-line treatment of B-cell acute lymphoblastic leukaemia (B-ALL), diffuse large B-cell lymphoma (DLBCL) and primary mediastinal B-cell lymphoma (PMBCL). This health technology assessment (HTA) evaluates the available evidence regarding the efficacy, effectiveness, safety, costs, cost-effectiveness and budget impact of tisa-cel and axi-cel compared to standard care in these populations. Ethical, legal, social and organisational issues associated with these therapies are also explored.
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Effectiveness, safety and cost-effectiveness of sacral neuromodulation for idiopathic slow-transit constipation: a systematic review.
Aim: Sacral neuromodulation (SNM) is a minimally invasive treatment option for functional constipation. Evidence regarding its effectiveness is contradictory, driven by heterogeneous study populations and designs. The aim of this study was to assess the effectiveness, safety and cost-effectiveness of SNM in children and adults with refractory idiopathic slow-transit constipation (STC). Method: OVID Medline, OVID Embase, Cochrane Library, the KSR Evidence Database, the NHS Economic Evaluation Database and the International HTA Database were searched up to 25 May 2023. For effectiveness outcomes, randomized controlled trials (RCTs) were selected. For safety outcomes, all study designs were selected. For cost-effectiveness outcomes, trial- and model-based economic evaluations were selected for review. Study selection, risk of bias and quality assessment, and data extraction were independently performed by two reviewers. For the intervention 'sacral neuromodulation' effectiveness outcomes included defaecation frequency and constipation severity. Safety and cost-effectiveness outcomes were, respectively, adverse events and incremental cost-effectiveness ratios. Results: Of 1390 records reviewed, 67 studies were selected for full-text screening. For effectiveness, one cross-over and one parallel-group RCT was included, showing contradictory results. Eleven studies on safety were included (four RCTs, three prospective cohort studies and four retrospective cohort studies). Overall infection rates varied between 0% and 22%, whereas reoperation rates varied between 0% and 29%. One trial-based economic evaluation was included, which concluded that SNM was not cost-effective compared with personalized conservative treatment at a time horizon of 6 months. The review findings are limited by the small number of available studies and the heterogeneity in terms of study populations, definitions of refractory idiopathic STC and study designs. Conclusion: Evidence for the (cost-)effectiveness of SNM in children and adults with refractory idiopathic STC is inconclusive. Reoperation rates of up to 29% were reported.
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Knowledge Graphs in Pharmacovigilance: A Scoping Review.
Purpose: To critically assess the role and added value of knowledge graphs in pharmacovigilance, focusing on their ability to predict adverse drug reactions. Methods: A systematic scoping review was conducted in which detailed information, including objectives, technology, data sources, methodology, and performance metrics, were extracted from a set of peer-reviewed publications reporting the use of knowledge graphs to support pharmacovigilance signal detection. Findings: The review, which included 47 peer-reviewed articles, found knowledge graphs were utilized for detecting/predicting single-drug adverse reactions and drug-drug interactions, with variable reported performance and sparse comparisons to legacy methods. Implications: Research to date suggests that knowledge graphs have the potential to augment predictive signal detection in pharmacovigilance, but further research using more reliable reference sets of adverse drug reactions and comparison with legacy pharmacovigilance methods are needed to more clearly define best practices and to establish their place in holistic pharmacovigilance systems.
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Intravenous immunoglobulin for treatment of hospitalized COVID-19 patients: an evidence mapping and meta-analysis
Background: The clinical efficacy and safety of intravenous immunoglobulin (IVIg) treatment for COVID-19 remain controversial. This study aimed to map the current status and gaps of available evidence, and conduct a meta-analysis to further investigate the benefit of IVIg in COVID-19 patients. Methods: Electronic databases were searched for systematic reviews/meta-analyses (SR/MAs), primary studies with control groups, reporting on the use of IVIg in patients with COVID-19. A random-effects meta-analysis with subgroup analyses regarding study design and patient disease severity was performed. Our outcomes of interest determined by the evidence mapping, were mortality, length of hospitalization (days), length of intensive care unit (ICU) stay (days), number of patients requiring mechanical ventilation, and adverse events. Results: We included 34 studies (12 SR/MAs, 8 prospective and 14 retrospective studies). A total of 5571 hospitalized patients were involved in 22 primary studies. Random-effects meta-analyses of very low to moderate evidence showed that there was little or no difference between IVIg and standard care or placebo in reducing mortality (relative risk [RR] 0.91; 95% CI 0.78-1.06; risk difference [RD] 3.3% fewer), length of hospital (mean difference [MD] 0.37; 95% CI - 2.56, 3.31) and ICU (MD 0.36; 95% CI - 0.81, 1.53) stays, mechanical ventilation use (RR 0.92; 95% CI 0.68-1.24; RD 2.8% fewer), and adverse events (RR 0.98; 95% CI 0.84-1.14; RD 0.5% fewer) of patients with COVID-19. Sensitivity analysis using a fixed-effects model indicated that IVIg may reduce mortality (RR 0.76; 95% CI 0.60-0.97), and increase length of hospital stay (MD 0.68; 95% CI 0.09-1.28). Conclusion: Very low to moderate certainty of evidence indicated IVIg may not improve the clinical outcomes of hospitalized patients with COVID-19. Given the discrepancy between the random- and fixed-effects model results, further large-scale and well-designed RCTs are warranted
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The Efficacy, Safety, and Economic Outcomes of Using Ferric Derisomaltose for the Management of Iron Deficiency in China: A Rapid Health Technology Assessment.
Intravenous (IV) iron supplementation is the preferred treatment option for managing severe iron deficiency (ID) and ID anemia (IDA). Three of the available IV iron preparations are ferric derisomaltose (FDI), ferric carboxymaltose (FCM), and iron sucrose (IS). The objective of the present work was to review the published literature about the efficacy, safety, quality of life (QoL), and economic outcomes of using FDI, FCM, and IS for the treatment of ID. A systematic literature search was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Eligible studies were assessed for quality using appropriate tools, and data were extracted and analyzed for key outcomes. The evidence synthesis was based on published systematic literature reviews (SLRs), meta-analyses (MAs), indirect treatment comparisons (ITCs), and health technology assessments (HTAs); we also included economic evaluations performed from a Chinese perspective. Out of 337 initial hits, the review included 12 studies. The findings indicated that FDI, FCM, and IS had comparable efficacy in terms of hemoglobin (Hb) improvement. FDI showed a better safety profile with a lower risk of hypophosphatemia, hypersensitivity reactions, and cardiovascular adverse events (AEs) compared to IS and FCM. FDI also demonstrated better cost-effectiveness compared to IS, with potential cost savings attributed to fewer infusions and improved compliance. None of the included studies evaluated QoL after IV iron administration for ID. FDI offers a safe, efficacious, and cost-effective treatment option for ID. It exhibits comparable efficacy to FCM and IS but presents a better safety profile and economic advantage. FDI fulfills the criteria of efficacy, safety, economy, innovation, suitability, and accessibility, making it a promising choice for ID management in China.
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Triage and diagnostic accuracy of online symptom checkers: Systematic review
BACKGROUND: In the context of a deepening global shortage of health workers and, in particular, the COVID-19 pandemic, there is growing international interest in, and use of, online symptom checkers (OSCs). However, the evidence surrounding the triage and diagnostic accuracy of these tools remains inconclusive. OBJECTIVE: This systematic review aimed to summarize the existing peer-reviewed literature evaluating the triage accuracy (directing users to appropriate services based on their presenting symptoms) and diagnostic accuracy of OSCs aimed at lay users for general health concerns. METHODS: Searches were conducted in MEDLINE, Embase, CINAHL, Health Management Information Consortium (HMIC), and Web of Science, as well as the citations of the studies selected for full-text screening. We included peer-reviewed studies published in English between January 1, 2010, and February 16, 2022, with a controlled and quantitative assessment of either or both triage and diagnostic accuracy of OSCs directed at lay users. We excluded tools supporting health care professionals, as well as disease- or specialty-specific OSCs. Screening and data extraction were carried out independently by 2 reviewers for each study. We performed a descriptive narrative synthesis. RESULTS: A total of 21,296 studies were identified, of which 14 (0.07%) were included. The included studies used clinical vignettes, medical records, or direct input by patients. Of the 14 studies, 6 (43%) reported on triage and diagnostic accuracy, 7 (50%) focused on triage accuracy, and 1 (7%) focused on diagnostic accuracy. These outcomes were assessed based on the diagnostic and triage recommendations attached to the vignette in the case of vignette studies or on those provided by nurses or general practitioners, including through face-to-face and telephone consultations. Both diagnostic accuracy and triage accuracy varied greatly among OSCs. Overall diagnostic accuracy was deemed to be low and was almost always lower than that of the comparator. Similarly, most of the studies (9/13, 69 %) showed suboptimal triage accuracy overall, with a few exceptions (4/13, 31%). The main variables affecting the levels of diagnostic and triage accuracy were the severity and urgency of the condition, the use of artificial intelligence algorithms, and demographic questions. However, the impact of each variable differed across tools and studies, making it difficult to draw any solid conclusions. All included studies had at least one area with unclear risk of bias according to the revised Quality Assessment of Diagnostic Accuracy Studies-2 tool. CONCLUSIONS: Although OSCs have potential to provide accessible and accurate health advice and triage recommendations to users, more research is needed to validate their triage and diagnostic accuracy before widescale adoption in community and health care settings. Future studies should aim to use a common methodology and agreed standard for evaluation to facilitate objective benchmarking and validation.
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Effectiveness of worksite wellness programs based on physical activity to improve workers' health and productivity: a systematic review.
Background: Although the scientific literature has previously described the impact of worksite programs based on physical activity (WPPAs) on employees' productivity and health in different contexts, the effect of these programs has not been analyzed based on the characteristics or modalities of physical activity (PA) performed (e.g., aerobic exercise, strength training, flexibility). In addition, studies on WPPAs usually report health and productivity outcomes separately, not integrated into a single study. Knowing the health and economic-related impacts of a WPPAs could provide useful information for stakeholders and policy development. Objective: The purpose of this review was as follows: (1) to analyze the effect of different modalities of WPPAs on employees' productivity and health and (2) to investigate the economic impact of WPPAs. Methods: This systematic review is registered in PROSPERO (CRD42021230626) and complies with PRISMA guidelines. Only randomized controlled trials from 1997 to March 2021 were included. Two reviewers independently screened abstracts and full texts for study eligibility, extracted the data, and performed a quality assessment using the Cochrane Collaboration Risk-of-Bias Tool for randomized trials. Population, instruments, comparison, and outcome (PICO) elements were used to define eligibility criteria. Eight-hundred sixty relevant studies were found through electronic searches in PubMed, Web of Science, Medline, Scopus, and SPORTDiscus databases. Once the eligibility criteria were applied, a total of 16 papers were included. Results: Workability was the productivity variable most positively impacted by WPPAs. Cardiorespiratory fitness, muscle strength, and musculoskeletal symptoms health variables improved in all the studies included. It was not possible to fully examine the effectiveness of each exercise modality because of the heterogeneity in methodology, duration, and working population. Finally, cost-effectiveness could not be analyzed because this information was not reported in most studies. Conclusion: All types of WPPAs analyzed improved workers' productivity and health. However, the heterogeneity of WPPAs does not allow to identify which modality is more effective.
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Veterans Health Administration (VA) vs. non-VA healthcare quality: A systematic review
BACKGROUND: The Veterans Health Administration (VA) serves Veterans in the nation's largest integrated healthcare system. VA seeks to provide high quality of healthcare to Veterans, but due to the VA Choice and MISSION Acts, VA increasingly pays for care outside of its system in the community. This systematic review compares care provided in VA and non-VA settings, and includes published studies from 2015 to 2023, updating 2 prior systematic reviews on this topic. METHODS: We searched PubMed, Web of Science, and PsychINFO from 2015 to 2023 for published literature comparing VA and non-VA care, including VA-paid community care. Records were included at the abstract or full-text level if they compared VA medical care with care provided in other healthcare systems, and included clinical quality, safety, access, patient experience, efficiency (cost), or equity outcomes. Data from included studies was abstracted by two independent reviewers, with disagreements resolved by consensus. Results were synthesized narratively and via graphical evidence maps. RESULTS: Thirty-seven studies were included after screening 2415 titles. Twelve studies compared VA and VA-paid community care. Most studies assessed clinical quality and safety, and studies of access were second most common. Only six studies assessed patient experience and six assessed cost or efficiency. Clinical quality and safety of VA care was better than or equal to non-VA care in most studies. Patient experience in VA care was better than or equal to experience in non-VA care in all studies, but access and cost/efficiency outcomes were mixed. DISCUSSION: VA care is consistently as good as or better than non-VA care in terms of clinical quality and safety. Access, cost/efficiency, and patient experience between the two systems are not well studied. Further research is needed on these outcomes and on services widely used by Veterans in VA-paid community care, like physical medicine and rehabilitation.
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Role of Traditional Chinese Medicine in Treating Severe or Critical COVID-19: A Systematic Review of Randomized Controlled Trials and Observational Studies
Background: The coronavirus disease 2019 (COVID-19) continues to spread globally. Due to the higher risk of mortality, the treatment of severe or critical patients is a top priority. Traditional Chinese medicine (TCM) treatment has played an extremely important role in the fight against COVID-19 in China; a timely evidence summary on TCM in managing COVID-19 is crucial to update the knowledge of healthcare for better clinical management of COVID-19. This study aimed to assess the effects and safety of TCM treatments for severe/critical COVID-19 patients by systematically collecting and synthesizing evidence from randomized controlled trials (RCTs) and observational studies (e.g., cohort). Methods: We searched nine databases up to 19th March 2022 and the reference lists of relevant publications. Pairs of reviewers independently screened studies, extracted data of interest, and assessed risk of bias. We performed qualitative systematic analysis with visual presentation of results and compared the direction and distribution of effect estimates for each patient's important outcome. We performed sensitivity analyses to observe the robustness of results by restricting analysis to studies with low risk of bias. Results: The search yielded 217,761 records, and 21 studies (6 RCTs and 15 observational studies) proved eligible. A total of 21 studies enrolled 12,981 severe/critical COVID-19 patients with a mean age of 57.21 years and a mean proportion of men of 47.91%. Compared with usual supportive treatments, the effect estimates of TCM treatments were consistent in direction, illustrating that TCM treatments could reduce the risk of mortality, rate of conversion to critical cases, and mechanical ventilation, and showed significant advantages in shortening the length of hospital stay, time to viral clearance, and symptom resolution. The results were similar when we restricted analyses to low-risk-bias studies. No serious adverse events were reported with TCM treatments, and no significant differences were observed between groups. Conclusion: Encouraging evidence suggests that TCM presents substantial advantages in treating severe/critical COVID-19 patients. TCM has a safety profile that is comparable to that of conventional treatment alone. TCMs have played an important role in China's prevention and treatment of COVID-19, which sets an example of using traditional medicine in preventing and treating COVID-19 worldwide.
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Chinese Medicine as an Adjunctive Treatment for Gastric Cancer: Methodological Investigation of meta-Analyses and Evidence Map
Background: Many meta-analyses (MAs) on Chinese medicine (CM) as an adjunctive treatment for gastric cancer have been published in recent years. However, the pooled evidence reported in MAs and their methodological quality remain unknown. Therefore, we designed a study to comprehensively evaluate and summarize the current evidence of CMs for gastric cancer in published MAs. Methods: A systematic search on MAs published in English from inception to 1st September 2021 was conducted in PubMed and Embase. The AMSTAR-2 tool was used to evaluate the methodological quality of the included MAs, and the results of the quality assessment were visualized using the evidence mapping method. Stata 17/SE was used for statistical analysis (Registration number: INPLASY202190005). Results: A total of 20 MAs (16 pairwise and 4 network MAs) were included from 118 records. These MAs were published in 14 journals from 2013 to 2021, with the number of patients and trials ranging from 688 to 6,857, and from 10 to 85, respectively. A large number of CMs (e.g., AiDi, FuFangKuShen, and HuaChanSu) in combination with chemotherapy for gastric cancer were identified among the included MAs. According to the pooled results reported in MAs, when compared to chemotherapy alone, CMs in combination with chemotherapy not only improve various outcomes on efficacy (e.g., objective response rate, quality of life) but also reduce various adverse reactions (e.g., leucopenia, nausea and vomiting). Only 2 MAs were low in terms of the overall methodological quality, while the other 18 MAs were all critically low. The methodology was required to be advanced significantly, mainly involving: study protocol and registration, explanation for the inclusion of study design, list of excluded studies with justifications, adequate details of included studies, reporting on funding sources of primary studies, and evaluation of the potential impact of risk of bias. In addition, MAs that received funds support (β = 2.68; 95%CI: 0.40 to 4.96; p = 0.024) or were published in journals with higher impact factor (β = 2.81; 95%CI: 0.69 to 4.92; p = 0.012) had a higher score on the overall methodological quality in the univariate analysis, but the results were not statistically significant according to the multivariate analysis. Conclusion: Combining CMs with chemotherapy can potentially improve clinical outcomes and reduce the relevant adverse effects in patients with gastric cancer. However, the methodological quality of relevant MAs requires significant improvement, and the current evidence needs to be validated through multinational trials that are well-designed and have a large sample size.
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Infliximab reference product versus biosimilar for the treatment of rheumatoid arthritis
Authors' objectives: Background: In Switzerland, relatively low biosimilar prescription rates have prompted the interest of the authorities. A health technology assessment (HTA) was requested to compare the available evidence of the infliximab reference product and its biosimilar for treating rheumatoid arthritis (RA). Objective: This HTA examines the efficacy, effectiveness and safety of the infliximab biosimilar compared to its reference product in RA and presents the health economic impact of a potentially increased biosimilar utilization in Switzerland. Furthermore, ethical, legal, social and organisational aspects of treatment initiation with biosimilars or switching to biosimilars are analysed. Research questions: Is it safe, efficacious and effective 1) to initiate treatment with infliximab biosimilar instead of the infliximab reference product, 2) to switch treatment from the infliximab reference product to infliximab biosimilar and 3) to switch treatment from infliximab biosimilar to the infliximab reference product in patients with RA?
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Clinical Efficacy and Safety of Proton and Carbon Ion Radiotherapy for Prostate Cancer: A Systematic Review and Meta-Analysis
Background & Carbon ion radiotherapy (CIRT) and proton beam therapy (PBT) are promising methods for prostate cancer, however, the consensus of an increasing number of studies has not been reached. We aimed to provide systematic evidence for evaluating the efficacy and safety of CIRT and PBT for prostate cancer by comparing photon radiotherapy. Materials and Methods: We searched for studies focusing on CIRT and PBT for prostate cancer in four online databases until July 2021. Two independent reviewers assessed the quality of included studies and used the GRADE approach to rate the quality of evidence. R 4.0.2 software was used to conduct the meta-analysis. A meta-regression test was performed based on the study design and tumor stage of each study. Results: A total of 33 studies including 13 CIRT- and 20 PBT-related publications, involving 54,101, participants were included. The quality of the included studies was found to be either low or moderate quality. Random model single-arm meta-analysis showed that both the CIRT and PBT have favorable efficacy and safety, with similar 5-year overall survival (OS) (94 vs 92%), the incidence of grade 2 or greater acute genitourinary (AGU) toxicity (5 vs 13%), late genitourinary (LGU) toxicity (4 vs 5%), acute gastrointestinal (AGI) toxicity (1 vs 1%), and late gastrointestinal (LGI) toxicity (2 vs 4%). However, compared with CIRT and PBT, photon radiotherapy was associated with lower 5-year OS (72-73%) and a higher incidence of grade 2 or greater AGU (28-29%), LGU (13-14%), AGI (14-19%), and LGI toxicity (8-10%). The meta-analysis showed the 3-, 4-, and 5-year local control rate (LCR) of CIRT for prostate cancer was 98, 97, and 99%; the 3-, 4-, 5-, and 8-year biochemical relapse-free rate (BRF) was 92, 91, 89, and 79%. GRADE assessment results indicated that the certainty of the evidence was very low. Meta-regression results did not show a significant relationship based on the variables studied (P < 0.05). Conclusions: Currently available evidence demonstrated that the efficacy and safety of CIRT and PBT for prostate cancer were similar, and they may significantly improve the OS, LCR, and reduce the incidence of GU and GI toxicity compared with photon radiotherapy. However, the quantity and quality of the available evidence are insufficient. More high-quality controlled studies are needed in the future.
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Dashboards for visual display of patient safety data: a systematic review
BACKGROUND: Methods to visualise patient safety data can support effective monitoring of safety events and discovery of trends. While quality dashboards are common, use and impact of dashboards to visualise patient safety event data remains poorly understood. OBJECTIVES: To understand development, use and direct or indirect impacts of patient safety dashboards. METHODS: We conducted a systematic review in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines. We searched PubMed, EMBASE and CINAHL for publications between 1 January 1950 and 30 August 2018 involving use of dashboards to display data related to safety targets defined by the Agency for Healthcare Research and Quality's Patient Safety Net. Two reviewers independently reviewed search results for inclusion in analysis and resolved disagreements by consensus. We collected data on development, use and impact via standardised data collection forms and analysed data using descriptive statistics. RESULTS: Literature search identified 4624 results which were narrowed to 33 publications after applying inclusion and exclusion criteria and consensus across reviewers. Publications included only time series and case study designs and were inpatient focused and emergency department focused. Information on direct impact of dashboards was limited, and only four studies included informatics or human factors principles in development or postimplementation evaluation. DISCUSSION: Use of patient-safety dashboards has grown over the past 15 years, but impact remains poorly understood. Dashboard design processes rarely use informatics or human factors principles to ensure that the available content and navigation assists task completion, communication or decision making. CONCLUSION: Design and usability evaluation of patient safety dashboards should incorporate informatics and human factors principles. Future assessments should also rigorously explore their potential to support patient safety monitoring including direct or indirect impact on patient safety.
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Characteristics of systematic reviews evaluating treatments for COVID-19 registered in PROSPERO
Characteristics and research collaboration of registered systematic reviews (SRs) on treatment modalities for coronavirus disease-2019 (COVID-19) remain unclear. This study analysed research collaboration, interventions and outcome measures in registered SRs on COVID-19 treatments and pointed out the relevant problems. PROSPERO (international prospective register of systematic reviews) was searched for SRs on COVID-19 treatments as of 2 June 2020. Excel 2016 was used for descriptive analyses of the extracted data. VOSviewer 1.6.14 software was used to generate network maps for collaborations between countries and institutions. A total of 189 SRs were included, which were registered by 301 institutions from 39 countries. China (69, 36.50%) exhibited the highest output. Cooperation between countries was not close enough. As an institution, the Chengdu University of Traditional Chinese Medicine (7, 3.70%) had the highest output. There was close cooperation between institutions. Interventions included antiviral therapy (81, 42.86%), respiratory support (16, 8.47%), circulatory support (11, 5.82%), plasma therapy for convalescent patients (11, 5.82%), immunotherapy (9, 4.76%), TCM (traditional Chinese medicine) treatment (9, 4.76%), rehabilitation treatment (5, 2.65%), anti-inflammatory treatment (16, 8.47%) and other treatments (31, 16.40%). Concerning antiviral therapy (81, 42.86%), the most commonly used antiviral agents were chloroquine/hydroxychloroquine (26, 13.76%), followed by remdesivir (12, 6.35%), lobinavir/ritonavir (11, 5.82%), favipiravir (5, 2.65%), ribavirin (5, 2.65%), interferon (5, 2.65%), abiron (4, 2.12%) and abidor (4, 2.12%). The most frequently used primary and secondary outcomes were the mortality rate (92, 48.68%) and hospital stay length (48, 25.40%), respectively. The expression of the outcomes was not standardised. Many COVID-19 SRs on treatment modalities have been registered, with a low completion rate. Although there was some collaboration between countries and institutions in the currently registered SRs on treatment modalities for COVID-19 on PROSPERO, cooperation between countries should be further enhanced. More attention should be directed towards identifying deficiencies of outcome measures, and the standardisation of results should be maximised.
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The effectiveness and safety of acupuncture for depression: An overview of meta-analyses
Purpose: To provide an overview of existing meta-analysis (MAs) on the efficacy and safety of acupuncture for depression, and assess the methodological quality and the strength of evidence of the included MAs. Methods: We searched MAs of randomized trials that have evaluated the effects of acupuncture on depression in three international and three Chinese databases from their inception until August 2019. The methodological quality of included MAs was evaluated with the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), and the strength of evidence with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). We used the intra-class correlation coefficient (ICC) to assess reviewer agreement in the pre-experiment. Results: We included 31 MAs and 59 RCTs. The results of included MAs were conflicting, our meta-analyses found that acupuncture may confer small benefit in reducing the severity of depression by end of treatment than no treatment/wait list/treatment as usual(SMD -0.74, 95% CI -1.06 to -0.41, eight trials, 624 participants), control acupuncture (invasive, non-invasive sham controls) (SMD 0.27, 95% CI -0.51 to -0.04, 20 trials, 1055 participants), antidepressants(Selective serotonin reuptake inhibitors (SSRI)/Tetracyclic antidepressants(TCAs)) (SMD -0.28, 95% CI -0.46 to -0.10, 30 trials, 3068 participants), acupuncture plus antidepressants versus antidepressants(SSRI/TCAs) (SMD -0.99, 95% CI -1.37 to -0.61, 17 trials, 1110 participants). Subgroup analyses showed that there was no difference between electro-acupuncture and invasive control (P = 0.37), electroacupuncture and non-invasive control (P = 0.90), manual acupuncture and Tetracyclic antidepressants (P = 0.57), electro-acupuncture and Tetracyclic antidepressants (P = 0.07). Six MAs concluded that acupuncture reduced the incidence of adverse events compared with antidepressants. The evaluation with AMSTAR-2 showed that the quality of included MAs was low or critically low. The results of the GRADE evaluation showed that the strength of evidence was low to very low for most outcomes. Conclusions: Although acupuncture appears to be more effective and safer than no treatment, control acupuncture and antidepressants, the quality of the available evidence was very low. Further methodologically rigorous and adequately powered primary studies are needed to confirm the effectiveness of acupuncture for depression.
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Patient safety in marginalised groups: A narrative scoping review
BACKGROUND: Marginalised groups ('populations outside of mainstream society') experience severe health inequities, as well as increased risk of experiencing patient safety incidents. To date however no review exists to identify, map and analyse the literature in this area in order to understand 1) which marginalised groups have been studied in terms of patient safety research, 2) what the particular patient safety issues are for such groups and 3) what contributes to or is associated with these safety issues arising. METHODS: Scoping review. Systematic searches were performed across six electronic databases in September 2019. The time frame for searches of the respective databases was from the year 2000 until present day. RESULTS: The searches yielded 3346 articles, and 67 articles were included. Patient safety issues were identified for fourteen different marginalised patient groups across all studies, with 69% (n = 46) of the studies focused on four patient groups: ethnic minority groups, frail elderly populations, care home residents and low socio-economic status. Twelve separate patient safety issues were classified. Just over half of the studies focused on three issues represented in the patient safety literature, and in order of frequency were: medication safety, adverse outcomes and near misses. In total, 157 individual contributing or associated factors were identified and mapped to one of seven different factor types from the Framework of Contributory Factors Influencing Clinical Practice within the London Protocol. Patient safety issues were mostly multifactorial in origin including patient factors, health provider factors and health care system factors. CONCLUSIONS: This review highlights that marginalised patient groups are vulnerable to experiencing a variety patient safety issues and points to a number of gaps. The findings indicate the need for further research to understand the intersectional nature of marginalisation and the multi-dimensional nature of patient safety issues, for groups that have been under-researched, including those with mental health problems, communication and cognitive impairments. Such understanding provides a basis for working collaboratively to co-design training, services and/or interventions designed to remove or at the very least minimise these increased risks.
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Patient safety in inpatient mental health settings: a systematic review.
Objectives: Patients in inpatient mental health settings face similar risks (eg, medication errors) to those in other areas of healthcare. In addition, some unsafe behaviours associated with serious mental health problems (eg, self-harm), and the measures taken to address these (eg, restraint), may result in further risks to patient safety. The objective of this review is to identify and synthesise the literature on patient safety within inpatient mental health settings using robust systematic methodology. Design: Systematic review and meta-synthesis. Embase, Cumulative Index to Nursing and Allied Health Literature, Health Management Information Consortium, MEDLINE, PsycINFO and Web of Science were systematically searched from 1999 to 2019. Search terms were related to 'mental health', 'patient safety', 'inpatient setting' and 'research'. Study quality was assessed using the Hawker checklist. Data were extracted and grouped based on study focus and outcome. Safety incidents were meta-analysed where possible using a random-effects model. Results: Of the 57 637 article titles and abstracts, 364 met inclusion criteria. Included publications came from 31 countries and included data from over 150 000 participants. Study quality varied and statistical heterogeneity was high. Ten research categories were identified: interpersonal violence, coercive interventions, safety culture, harm to self, safety of the physical environment, medication safety, unauthorised leave, clinical decision making, falls and infection prevention and control. Conclusions: Patient safety in inpatient mental health settings is under-researched in comparison to other non-mental health inpatient settings. Findings demonstrate that inpatient mental health settings pose unique challenges for patient safety, which require investment in research, policy development, and translation into clinical practice. Prospero registration number: CRD42016034057.
研究证据
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Impact of the communication and patient hand-off tool SBAR on patient safety: A systematic review
OBJECTIVES: Communication breakdown is one of the main causes of adverse events in clinical routine, particularly in handover situations. The communication tool SBAR (situation, background, assessment and recommendation) was developed to increase handover quality and is widely assumed to increase patient safety. The objective of this review is to summarise the impact of the implementation of SBAR on patient safety. DESIGN: A systematic review of articles published on SBAR was performed in PUBMED, EMBASE, CINAHL, Cochrane Library and PsycINFO in January 2017. All original research articles on SBAR fulfilling the following eligibility criteria were included: (1) SBAR was implemented into clinical routine, (2) the investigation of SBAR was the primary objective and (3) at least one patient outcome was reported. SETTING: A wide range of settings within primary and secondary care and nursing homes. PARTICIPANTS: A variety of heath professionals including nurses and physicians. PRIMARY AND SECONDARY OUTCOME MEASURES: Aspects of patient safety (patient outcomes) defined as the occurrence or incidence of adverse events. RESULTS: Eight studies with a before-after design and three controlled clinical trials performed in different clinical settings met the inclusion criteria. The objectives of the studies were to improve team communication, patient hand-offs and communication in telephone calls from nurses to physicians. The studies were heterogeneous with regard to study characteristics, especially patient outcomes. In total, 26 different patient outcomes were measured, of which eight were reported to be significantly improved. Eleven were described as improved but no further statistical tests were reported, and six outcomes did not change significantly. Only one study reported a descriptive reduction in patient outcomes. CONCLUSIONS: This review found moderate evidence for improved patient safety through SBAR implementation, especially when used to structure communication over the phone. However, there is a lack of high-quality research on this widely used communication tool. TRIAL REGISTRATION: none.
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