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Oral direct thrombin inhibitors or oral factor Xa inhibitors versus conventional anticoagulants for the treatment of deep vein thrombosis
Background:Deep vein thrombosis (DVT) is a condition in which a clot forms in the deep veins, most commonly of the leg. It occurs in approximately one in 1000 people. If left untreated, the clot can travel up to the lungs and cause a potentially life-threatening pulmonary embolism (PE). Previously, a DVT was treated with the anticoagulants heparin and vitamin K antagonists. However, two forms of direct oral anticoagulants (DOACs) have been developed: oral direct thrombin inhibitors (DTIs) and oral factor Xa inhibitors, which have characteristics that may be favourable compared to conventional treatment, including oral administration, a predictable effect, lack of frequent monitoring or dose adjustment and few known drug interactions. DOACs are now commonly being used for treating DVT: recent guidelines recommended DOACs over conventional anticoagulants for both DVT and PE treatment. This Cochrane Review was first published in 2015. It was the first systematic review to measure the effectiveness and safety of these drugs in the treatment of DVT. This is an update of the 2015 review. OBJECTIVES: To assess the effectiveness and safety of oral DTIs and oral factor Xa inhibitors versus conventional anticoagulants for the long-term treatment of DVT. Search methods:The Cochrane Vascular Information Specialist searched the Cochrane Vascular Specialised Register, CENTRAL, MEDLINE, Embase and CINAHL databases and the World Health Organization International Clinical Trials Registry Platform and ClinicalTrials.gov trials registers to 1 March 2022. Selection criteria:We included randomised controlled trials (RCTs) in which people with a DVT, confirmed by standard imaging techniques, were allocated to receive an oral DTI or an oral factor Xa inhibitor compared with conventional anticoagulation or compared with each other for the treatment of DVT. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were recurrent venous thromboembolism (VTE), recurrent DVT and PE. Secondary outcomes included all-cause mortality, major bleeding, post-thrombotic syndrome (PTS) and quality of life (QoL). We used GRADE to assess the certainty of evidence for each outcome. Main results:We identified 10 new studies with 2950 participants for this update. In total, we included 21 RCTs involving 30,895 participants. Three studies investigated oral DTIs (two dabigatran and one ximelagatran), 17 investigated oral factor Xa inhibitors (eight rivaroxaban, five apixaban and four edoxaban) and one three-arm trial investigated both a DTI (dabigatran) and factor Xa inhibitor (rivaroxaban). Overall, the studies were of good methodological quality. Meta-analysis comparing DTIs to conventional anticoagulation showed no clear difference in the rate of recurrent VTE (odds ratio (OR) 1.17, 95% confidence interval (CI) 0.83 to 1.65; 3 studies, 5994 participants; moderate-certainty evidence), recurrent DVT (OR 1.11, 95% CI 0.74 to 1.66; 3 studies, 5994 participants; moderate-certainty evidence), fatal PE (OR 1.32, 95% CI 0.29 to 6.02; 3 studies, 5994 participants; moderate-certainty evidence), non-fatal PE (OR 1.29, 95% CI 0.64 to 2.59; 3 studies, 5994 participants; moderate-certainty evidence) or all-cause mortality (OR 0.66, 95% CI 0.41 to 1.08; 1 study, 2489 participants; moderate-certainty evidence). DTIs reduced the rate of major bleeding (OR 0.58, 95% CI 0.38 to 0.89; 3 studies, 5994 participants; high-certainty evidence). For oral factor Xa inhibitors compared with conventional anticoagulation, meta-analysis demonstrated no clear difference in recurrent VTE (OR 0.85, 95% CI 0.71 to 1.01; 13 studies, 17,505 participants; moderate-certainty evidence), recurrent DVT (OR 0.70, 95% CI 0.49 to 1.01; 9 studies, 16,439 participants; moderate-certainty evidence), fatal PE (OR 1.18, 95% CI 0.69 to 2.02; 6 studies, 15,082 participants; moderate-certainty evidence), non-fatal PE (OR 0.93, 95% CI 0.68 to 1.27; 7 studies, 15,166 participants; moderate-certainty evidence) or all-cause mortality (OR 0.87, 95% CI 0.67 to 1.14; 9 studies, 10,770 participants; moderate-certainty evidence). Meta-analysis showed a reduced rate of major bleeding with oral factor Xa inhibitors compared with conventional anticoagulation (OR 0.63, 95% CI 0.45 to 0.89; 17 studies, 18,066 participants; high-certainty evidence). AUTHORS' CONCLUSIONS: The current review suggests that DOACs may be superior to conventional therapy in terms of safety (major bleeding), and are probably equivalent in terms of efficacy. There is probably little or no difference between DOACs and conventional anticoagulation in the prevention of recurrent VTE, recurrent DVT, pulmonary embolism and all-cause mortality. DOACs reduced the rate of major bleeding compared to conventional anticoagulation. The certainty of evidence was moderate or high.
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Effect of pharmacist intervention on medication therapy management for general populations: A meta-analysis
Objective: To assess the overall effect of pharmacist-involved medication therapy management (MTM) on patient outcomes and to interpret the assessment for a general population. Methods: Many small studies have documented the influence the pharmacist's role within MTM for specific populations. However, not many studies have documented the impact of the importance of a pharmacist in MTM overall in general populations. A stronger indicator of improved patient outcomes with a pharmacist-led MTM could lead to larger studies and better health care policy in the future. A literature search of published studies (hospital and community settings) was performed in Medline (via PubMed), the International Pharmaceutical Abstracts, and Embase. Studies were also identified from the references in these articles and in reviews. For a study to be included in this meta-analysis, it must have a pharmacist-involved medication intervention. The included studies were published no earlier than January 2009 in developed countries. All studies with less than 50 participants or a follow-up period less than 16 weeks were excluded. The recommendations of Cochrane Collaboration and the Quality of Reporting of Meta-analyses guidelines were also implemented. Results: Preliminary data analysis suggests a significant improvement in patient outcomes with a pharmacist-involved MTM. When observing strictly patient adherence in three previously selected trials, the pharmacist intervention had a 7% greater patient adherence versus the control intervention. Conclusion: NA (research in progress)
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Virtual reality and cardiac diseases: A systematic review of applications and effects
INTRODUCTION: Cardiac diseases have grown significantly in recent years, causing many deaths globally. Cardiac diseases can impose a significant economic burden on societies. The development of virtual reality technology has attracted the attention of many researchers in recent years. This study aimed to investigate the applications and effects of virtual reality (VR) technology on cardiac diseases. METHODS: A comprehensive search was carried out in four databases, including Scopus, Medline (through PubMed), Web of Science, and IEEE Xplore to identify related articles published until May 25, 2022. Preferred Reporting Items for Systematic Reviews and Meta-Analyzes (PRISMA) guideline for systematic reviews was followed. All randomized trials that investigated the effects of virtual reality on cardiac diseases were included in this systematic review. RESULTS: Twenty-six studies were included in this systematic review. The results illustrated that virtual reality applications in cardiac diseases can be classified in three categories of physical rehabilitation, psychological rehabilitation, and education/training. This study revealed that the use of virtual reality in psychological and physical rehabilitation can reduce stress, emotional tension, Hospital Anxiety and Depression Scale (HADS) total score, anxiety, depression, pain, systolic blood pressure, and length of hospitalization. Finally, the use of virtual reality in education/training can enhance technical performance, increase the speed of procedures, and improve the user's skills, level of knowledge, and self-confidence as well as facilitate learning. Also, the most limitations mentioned in the studies included small sample size and lack of or short duration of follow-up. CONCLUSIONS: The results showed that the positive effects of using virtual reality in cardiac diseases are much more than its negative effects. Considering that the most limitations mentioned in the studies were the small sample size and short duration of follow-up, it is necessary to conduct studies with adequate methodological quality to report their effects in the short term and long term.
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Health System Governance Evaluation: A Scoping Review.
Background: Governance is one of the critical functions of the health system. Good governance of the health system leads to better performance and outcomes. Evaluation is the first step to improving health system governance. Therefore, this research aimed to identify evaluation tools for health system governance. Methods: In the current scoping review, we searched all documents related to health system governance evaluation indexed in Medline, EMBASE, ProQuest, Scopus, Cochrane Library, Science Direct databases, and Google Scholar search engines to 2022, extracted, and assessed. Finally, documents were selected and analyzed by thematic analysis. Results: Thirty tools were found to evaluate health system governance. Among the proposed tools, 11 specific tools have been designed just for health system governance evaluation, while others have governance as a component of health system evaluation. Health system governance's significant components are health policy-making, strategic planning, organizing, stewardship, and control. Indicators such as accountability, participation, transparency, equity, efficiency, accountability, corruption control, effectiveness, ethic, the rule of law, and sustainability could be used to evaluate the health system governance. Conclusion: Different tools have been used to evaluate governance worldwide, and each governance evaluation tool has different components suitable for governance evaluation. However, these tools cannot fully evaluate governance and have shortcomings. A comprehensive evaluation of governance and sharing lessons denrael will affect the health system's capacity and ability to provide quality, safe and effective health services. It will lead to the stability of the health system.
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Trends in research related to menopausal hormone therapy from 2000 to 2021: A bibliometric analysis
We conducted the present bibliometric analysis to explore menopausal hormone therapy (MHT)-related research trends between 2000 and 2021. The Web of Science database was systematically searched from 2000 to 2021 to retrieve MHT-related publications. Visualization mapping and keyword cluster graphs were utilized to illustrate the research topics and hotpots. We included 11,616 MHT-related publications for this bibliometric analysis. The results showed that (1) MHT-related research had a very slow increase in the past 22 years, and the trend fluctuated. Sum of times cited and average citations per item had the same trend: a sharp decline from 2002 to 2003, and a rapid increase from 2003 to 2006, reaching the peak in 2006, then following a downward trend. The average H-index was 57, peaking in 2001; (2) the USA, the League of European Research Universities, and Dr. JoAann Manson from Harvard University contributed the most; (3) Menopause: The Journal of The North American Menopause Society had the most significant number of MHT-related publications; (4) the research hotpots primarily focused on MHT for treating menopausal symptoms and the impact of MHT on women's health. According to previous studies, MHT was the most effective treatment for managing vasomotor symptoms of menopause, but results from the clinical trials and observational studies regarding MHT adverse events remain inconsistent. Mechanisms are fundamental when clinical studies give conflicting results. Therefore, future studies should focus on adverse events and their mechanisms.
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Efficacy and safety of unrestricted visiting policy for critically ill patients: a meta-analysis
Aim To compare the safety and effects of unrestricted visiting policies (UVPs) and restricted visiting policies (RVPs) in intensive care units (ICUs) with respect to outcomes related to delirium, infection, and mortality. Methods MEDLINE, Cochrane Library, Embase, Web of Science, CINAHL, CBMdisc, CNKI, Wanfang, and VIP database records generated from their inception to 22 January 2022 were searched. Randomized controlled trials and quasi-experimental studies were included. The main outcomes investigated were delirium, ICU-acquired infection, ICU mortality, and length of ICU stay. Two reviewers independently screened studies, extracted data, and assessed risks of bias. Random-effects and fixed-effects meta-analyses were conducted to obtain pooled estimates, due to heterogeneity. Meta-analyses were performed using RevMan 5.3 software. The results were analyzed using odds ratios (ORs), 95% confidence intervals (CIs), and standardized mean differences (SMDs). Results Eleven studies including a total of 3741 patients that compared UVPs and RVPs in ICUs were included in the analyses. Random effects modeling indicated that UVPs were associated with a reduced incidence of delirium (OR = 0.4, 95% CI 0.25-0.63, I-2 = 71%, p = 0.0005). Fixed-effects modeling indicated that UVPs did not increase the incidences of ICU-acquired infections, including ventilator-associated pneumonia (OR = 0.96, 95% CI 0.71-1.30, I-2 = 0%, p = 0.49), catheter-associated urinary tract infection (OR 0.97, 95% CI 0.52-1.80, I-2 = 0%, p = 0.55), and catheter-related blood stream infection (OR = 1.15, 95% CI 0.72-1.84, I-2 = 0%, p = 0.66), or ICU mortality (OR = 1.03, 95% CI 0.83-1.28, I-2 = 49%, p = 0.12). Forest plotting indicated that UVPs could reduce the lengths of ICU stays (SMD = - 0.97, 95% CI - 1.61 to 0.32, p = 0.003). Conclusion The current meta-analysis indicates that adopting a UVP may significantly reduce the incidence of delirium in ICU patients, without increasing the risks of ICU-acquired infection or mortality. Further large-scale, multicenter studies are needed to confirm these indications.
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Interventions to reengage people living with HIV who are lost to follow-up from HIV treatment programs: A systematic review and meta-analysis
BACKGROUND: Optimizing services to facilitate engagement and retention in care of people living with HIV (PLWH) on antiretroviral therapies (ARTs) is critical to decrease HIV-related morbidity and mortality and HIV transmission. We systematically reviewed the literature for the effectiveness of implementation strategies to reestablish and subsequently retain clinical contact, improve viral load suppression, and reduce mortality among patients who had been lost to follow-up (LTFU) from HIV services. METHODS AND FINDINGS: We searched 7 databases (PubMed, Cochrane, ERIC, PsycINFO, EMBASE, Web of Science, and the WHO regional databases) and 3 conference abstract archives (CROI, IAC, and IAS) to find randomized trials and observational studies published through 13 April 2020. Eligible studies included those involving children and adults who were diagnosed with HIV, had initiated ART, and were subsequently lost to care and that reported at least one review outcome (return to care, retention, viral suppression, or mortality). Data were extracted by 2 reviewers, with discrepancies resolved by a third. We characterized reengagement strategies according to how, where, and by whom tracing was conducted. We explored effects, first, among all categorized as LTFU from the HIV program (reengagement program effect) and second among those found to be alive and out of care (reengagement contact outcome). We used random-effect models for meta-analysis and conducted subgroup analyses to explore heterogeneity. Searches yielded 4,244 titles, resulting in 37 included studies (6 randomized trials and 31 observational studies). In low- and middle-income countries (LMICs) (N = 16), tracing most frequently involved identification of LTFU from the electronic medical record (EMR) and paper records followed by a combination of telephone calls and field tracing (including home visits), by a team of outreach workers within 3 months of becoming LTFU (N = 7), with few incorporating additional strategies to support reengagement beyond contact (N = 2). In high-income countries (HICs) (N = 21 studies), LTFU were similarly identified through EMR systems, at times matched with other public health records (N = 4), followed by telephone calls and letters sent by mail or email and conducted by outreach specialist teams. Home visits were less common (N = 7) than in LMICs, and additional reengagement support was similarly infrequent (N = 5). Overall, reengagement programs were able to return 39% (95% CI: 31% to 47%) of all patients who were characterized as LTFU (n = 29). Reengagement contact resulted in 58% (95% CI: 51% to 65%) return among those found to be alive and out of care (N = 17). In 9 studies that had a control condition, the return was higher among those in the reengagement intervention group than the standard of care group (RR: 1.20 (95% CI: 1.08 to 1.32, P < 0.001). There were insufficient data to generate pooled estimates of retention, viral suppression, or mortality after the return. CONCLUSIONS: While the types of interventions are markedly heterogeneity, reengagement interventions increase return to care. HIV programs should consider investing in systems to better characterize LTFU to identify those who are alive and out of care, and further research on the optimum time to initiate reengagement efforts after missed visits and how to best support sustained reengagement could improve efficiency and effectiveness.
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Siponimod for multiple sclerosis
Background: Multiple sclerosis (MS) is a chronic immune-mediated disease of the central nervous system, with an unpredictable course. Current MS therapies such as disease-modifying therapies focus on treating exacerbations, preventing new exacerbations and avoiding the progression of disability. Siponimod (BAF312) is an oral treatment, a selective sphingosine-1-phosphate (S1P) receptor modulator, for the treatment of adults with relapsing forms of MS including active, secondary progressive MS with relapses. Objectives: To assess the benefits and adverse effects of siponimod as monotherapy or combination therapy versus placebo or any active comparator for people diagnosed with MS. Search methods: On 18 June 2020, we searched the Cochrane Multiple Sclerosis and Rare Diseases of the CNS Trials Register, which contains studies from CENTRAL, MEDLINE and Embase, and the trials registry databases ClinicalTrials.gov and WHO International Clinical Trials Registry Platform (ICTRP). We also handsearched relevant journals and screened the reference lists of published reviews and retrieved articles and searched reports (2004 to June 2020) from the MS societies in Europe and America. Selection criteria: We included randomised parallel controlled clinical trials (RCTs) that evaluated siponimod, as monotherapy or combination therapy, versus placebo or any active comparator in people with MS. There were no restrictions on dose or administration frequency. Data collection and analysis: We used standard methodological procedures expected by Cochrane. We discussed disagreements and resolved them by consensus among the review authors. Our primary outcomes wereworsening disability, relapse and adverse events, and secondary outcomes were annualised relapse rate, gadolinium-enhancing lesions, new lesions or enlarged pre-existing lesions and mean change of brain volume. We independently evaluated the certainty of evidence using the GRADE approach. We contacted principal investigators of included studies for additional data or confirmation of data. Main results: Two studies (1948 participants) met our selection criteria, 608 controls and 1334 treated with siponimod. The included studies compared siponimod with placebo. Overall, all studies had a high risk of bias due to selective reporting and attrition bias. Comparing siponimod administered at a dose of 2 mg to placebo, we found that siponimod may reduce the number of participants with disability progression at six months (56 fewer people per 1000; risk ratio (RR) 0.78, 95% confidence interval (CI) 0.65 to 0.94; 1 study, 1641 participants; low-certainty evidence) and annualised relapse rate (RR 0.43, 95% CI 0.34 to 0.56; 2 studies, 1739 participants; low-certainty evidence). But it might lead to little reduction in the number of participants with new relapse (166 fewer people per 1000; RR 0.38, 95% CI 0.15 to 1.00; 1 study, 94 participants; very low-certainty evidence). We observed no evidence of a difference due to adverse events for siponimod at 2 mg compared to placebo (14 more people per 1000; RR 1.52, 95% CI 0.85 to 2.71; 2 studies, 1739 participants, low-certainty evidence). In addition, due to the high risk of inaccurate magnetic resonance imaging (MRI) data in the two included studies, we could not combine data for active lesions on MRI scans. Both studies had high attrition bias resulting from the unbalanced reasons for dropouts among groups and high risk of bias due to conflicts of interest. Siponimod may reduce the number of gadolinium-enhancing T1-weighted lesions at two years of follow-up (RR 0.14, 95% CI 0.10 to 0.19; P < 0.0001; 1 study, 1641 participants; very low-certainty evidence). There may be no evidence of a difference between groups in the number of participants with at least one serious adverse event excluding relapses (113 more people per 1000; RR 1.80, 95% CI 0.37 to 8.77; 2 studies, 1739 participants; low-certainty evidence) at six months. No data were available regarding cardiac adverse events. In terms of safety profile, the most common adverse events associated with siponimod were headache, back pain, bradycardia, dizziness, fatigue, influenza, urinary tract infection, lymphopenia, nausea, alanine amino transferase increase and upper respiratory tract infection. These adverse events have dose-related effects and rarely led to discontinuation of treatment. Authors' conclusions: Based on the findings of the RCTs included in this review, we are uncertain whether siponimod interventions are beneficial for people with MS. There was low-certainty evidence to support that siponimod at a dose of 2 mg orally once daily as monotherapy compared with placebo may reduce the annualised relapse rate and the number of participants who experienced disability worsening, at 6 months. However, the certainty of the evidence to support the benefit in reducing the number of people with a relapse is very low. The risk of withdrawals due to adverse events requires careful monitoring of participants over time. The duration of all studies was less than 24 months, so the efficacy and safety of siponimod over 24 months are still uncertain, and further exploration is needed in the future. There is no high-certainty data available to evaluate the benefit on MRI outcomes. We assessed the certainty of the body of evidence for all outcomes was low to very low, downgraded due to serious study limitations, imprecision and indirectness. We are uncertain whether siponimod is beneficial for people with MS. More new studies with robust methodology and longer follow-up are needed to evaluate the benefit of siponimod for the management of MS and to observe long-term adverse effects. Also, in addition to comparing with placebo, more new studies are needed to evaluate siponimod versus other therapeutic options
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The effectiveness of acupuncture for Parkinson's disease: An overview of systematic reviews
Objectives Acupuncture is an alternative therapy for Parkinson’s disease (PD), but its efficacy and safety are controversial. This overview aimed to summarize the existing evidence from systematic reviews (SRs) and meta-analyses (MAs) in order to assess the effectiveness of acupuncture as a treatment for PD. Methods Seven electronic databases were searched from their inception until July 2019. The Grading of Recommendations, Assessment, Development, and Evaluation (GRADE) and Assessment of Multiple Systematic Reviews 2 (AMSTAR2) checklists were used to assess evidence quality and methodological quality, respectively. The outcomes of study were calculated using mean differences (MDs) and risk ratios (RRs) with 95 % confidence intervals (CIs). A meta-analysis was performed using RevMan 5.3 software. Results A total of 12 SRs/MAs were included. All 12 SRs/MAs had more than one critical weakness in AMSTAR 2 and were considered of critically low methodological quality. The quality of evidence was unsatisfactory according to the GRADE checklist. Meta-analyses showed that acupuncture combined with drug for the treatment of PD can significantly improve the total effectiveness rate compared with drug alone (RR = 1.25, 95 % CI 1.16–1.34, P < 0.001). It was also found that acupuncture combined with drug significantly improved the UPDRS I–IV total summed scores (WMD=−6.18, 95 % CI -10.32 to –2.04, P < 0.001) and Webster scores (WMD=−4.20, 95 % CI -7.59 to –0.81, P < 0.001). Conclusion Acupuncture might improve the UPDRS score, Webster score, and total effective rate in treatment of PD. It might be a safe and useful adjunctive treatment for patients with PD. However, we should interpret the findings of these reviews with caution, considering the overall limited methodological and reporting quality.
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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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The effectiveness of peer and community health worker-led self-management support programs for improving diabetes health-related outcomes in adults in low- and-middle-income countries: A systematic review
OBJECTIVE: Community-based peer and community health worker-led diabetes self-management programs (COMP-DSMP) can benefit diabetes care, but the supporting evidence has been inadequately assessed. This systematic review explores the nature of COMP-DSMP in low- and middle-income countries' (LMIC) primary care settings and evaluates implementation strategies and diabetes-related health outcomes. METHODS: We searched the Cochrane Library, PubMed-MEDLINE, SCOPUS, CINAHL PsycINFO Database, International Clinical Trials Registry Platform, Clinicaltrials.gov, Pan African Clinical Trials Registry (PACTR), and HINARI (Health InterNetwork Access to Research Initiative) for studies that evaluated a COMP-DSMP in adults with either type 1 or type 2 diabetes in World Bank-defined LMIC from January 2000 to December 2019. Randomised and non-randomised controlled trials with at least 3 months follow-up and reporting on a behavioural, a primary psychological, and/or a clinical outcome were included. Implementation strategies were analysed using the standardised implementation framework by Proctor et al. Heterogeneity in study designs, outcomes, the scale of measurements, and measurement times precluded meta-analysis; thus, a narrative description of studies is provided. RESULTS: Of the 702 records identified, eleven studies with 6090 participants were included. COMP-DSMPs were inconsistently associated with improvements in clinical, behavioural, and psychological outcomes. Many of the included studies were evaluated as being of low quality, most had a substantial risk of bias, and there was a significant heterogeneity of the intervention characteristics (for example, peer definition, selection, recruitment, training and type, dose, and duration of delivered intervention), such that generalisation was not possible. CONCLUSIONS: The level of evidence of this systematic review was considered low according to the GRADE criteria. The existing evidence however does show some improvements in outcomes. We recommend ongoing, but well-designed studies using a framework such as the MRC framework for the development and evaluation of complex interventions to inform the evidence base on the contribution of COMP-DSMP in LMIC.
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Acupuncture for treatment of anxiety, an overview of systematic reviews
Purpose: To evaluate the methodological quality and summarize evidence of important outcomes of systematic reviews (SRs)/Meta analyses (MM) of acupuncture for anxiety. Methods: We conducted a comprehensive literature search for SRs/MAs in PubMed, EMBASE, Cochrane library, Chinese Biomedical Databases (CBM), Wanfang database and China National Knowledge Infrastructure (CNKI) until November 30, 2018. Three reviewers independently extracted data and assessed the methodological quality of the reviews according to the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), the Grading of Recommendations, Assessment, Development and Evaluation (GRADE) was used to rate the quality of evidence. In the pre-experiment, we used the intra-class correlation coefficient (ICC) to assess reviewer agreement, the ICC value for overall score was 0.978. Results: Ten reviews were included. The assessment results of AMSTAR-2 showed that the methodological quality of all included studies was critically low. The lowest score were item "provide a list of excluded studies and justify the exclusions" and item "report sources of funding for the included studies", none of studies provided information about the above two items, followed by the "providing a priori design" item with only two (20%) studies conforming to this item. For GRADE, of the 7 outcomes, high quality evidence was provided in only 1 (14.3%), moderate in 2 (28.6.7%), and low in 4 (57.1%). Conclusion: Although most of the included reviews indicated that acupuncture group was more effective than control group in the treatment of anxiety, more importantly, the methodological quality of the included reviews and the quality of evidence were low. More high-quality evidence is needed to determine whether acupuncture is more effective than other treatments.
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Prevalence, pattern, magnitude and associated factors of trauma in the Emergency Department at Health Institutes in Ethiopia: A systematic review.
Background: Trauma is one of the important public health problems that causes significant economic and social crisis with more than 10% of all disease cases are associated with it. We aimed to identify and describe the prevalence, patterns, magnitude and associated factors of trauma in the Emergency Department at Health Institute in Ethiopia. Methods: In this systematic review, we searched for peer-reviewed and grey literature publications reporting the prevalence, pattern, magnitude and associated factors of trauma between 2000 and 2019. The documents which recruited are directly related to trauma and emergency department. In this regard, we searched databases of PubMed, Elsevier, Science directed, MEDLINE, and Google scholar by using Google as searching engine. Furthermore, publication with secondary data and not in English was excluded. Findings: A total of 9,768 injured participants were included in the studies, of which 71.2% (6950) were males. Among the injured participants, 53.4% of cases were living in Addis Ababa followed by Gondar and Jimma with 20.3% and 11.3% cases, respectively. Severe road traffic accident, occupational injury, and surgical patients were among the major risk factors of trauma. The mortality rate of the trauma case fatality was reached about 4%. The majority of the studies (37.5%) analyzed the pattern and magnitude of trauma among patients seen at emergency outpatient department of health institutes in Ethiopia. The largest percentage of studies (62.5%) relied on systematic random sampling. Thirty eight percent of the reviewed studies were utilized retrospective approaches to address the research questions. An completed the registry forms and/or Kampla Trauma Score (KTS), which accounted for 37.5% of articles on prevalence, pattern, magnitude and associated factors of trauma in the emergency was the most commonly used strategy. The majority (75%) of the reviewed studies were used both descriptive statistics and bivarate and multivariate logistic regression for data analysis. The majority 6950 (71%) of the participants who have been included in those reviewed articles were male and 2818 (29%) were female by gender. Meanwhile, the majority 5 (62.5%) of reviewed studies had included < 1000 injured persons. Conclusion: The degree and types of injuries in different hospitals in Ethiopia was considerably high and its casualty is also under predictable. Therefore, a variety of actions including policy decision should be implemented in order to minimize the incidence of trauma at department of emergency care center in the country.
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Caregiver-focused, web-based interventions: Systematic review and meta-analysis (Part 2)
BACKGROUND: Approaches to support the health and well-being of family caregivers of adults with chronic conditions are increasingly important given the key roles caregivers play in helping family members to live in the community. Web-based interventions to support caregivers have the potential to lessen the negative health impacts associated with caregiving and result in improved health outcomes. OBJECTIVE: The primary objective of this systematic review and meta-analysis was to examine the effect of caregiver-focused, Web-based interventions, compared with no or minimal Web-based interventions, on caregiver outcomes. The secondary objective was to assess the effect of different types of Web-based interventions (eg, education, peer and professional psychosocial support, and electronic monitoring of the care recipient), compared with no or minimal Web-based interventions, on caregiver outcomes. METHODS: MEDLINE, EMBASE, CIHAHL, PsychInfo, Cochrane, and AgeLine were searched from January 1995 to April 2017 for relevant randomized controlled trials (RCTs) or controlled clinical trials (CCTs) that compared caregiver-focused, Web-based intervention programs with no or minimal Web-based interventions for caregivers of adults with at least one chronic condition. Studies were included if they involved: adult family or friend caregivers (aged >/=18 years) of adults living in the community with a chronic condition; a caregiver-focused, Web-based intervention of education or psychosocial support or electronic monitoring of the care recipient; and general caregiver outcomes (ie, burden, life satisfaction, self-efficacy or mastery, reaction to problem behavior, self-esteem, strain, and social support). Title and abstract as well as full-text screening were completed in duplicate. Data were extracted by a single reviewer and verified by a second reviewer, and risk of bias assessments were completed accordingly. Where possible, data for these caregiver outcomes were meta-analyzed. RESULTS: The search yielded 7927 unique citations, of which 294 studies were screened at full text. Of those, 14 studies met the inclusion criteria; 12 were RCTs and 1 study was a CCT. One study used an RCT design in 1 country and a CCT design in 2 other countries. The beneficial effects of any Web-based intervention program, compared with no or minimal Web-based intervention, resulted in a mean increase of 0.85 points (95% CI 0.12 to 1.57) for caregiver self-esteem, a mean increase of 0.36 points (95% CI 0.11 to 0.62) for caregiver self-efficacy or mastery, and a mean decrease of 0.32 points (95% CI -0.54 to -0.09) for caregiver strain. However, the results are based on poor-quality studies. CONCLUSIONS: The review found evidence for the positive effects of Web-based intervention programs on self-efficacy, self-esteem, and strain of caregivers of adults living with a chronic condition. Further high-quality research is needed to inform the effectiveness of specific types of Web-based interventions on caregiver outcomes.
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Effectiveness of self-help psychological interventions for treating and preventing postpartum depression: A meta-analysis
Previous studies have reported different effect sizes for self-help interventions designed to reduce postpartum depression symptoms; therefore, a comprehensive quantitative review of the research was required. A meta-analysis was conducted to examine the effectiveness of self-help interventions designed to treat and prevent postpartum depression, and identified nine relevant randomized controlled trials. Differences in depressive symptoms between self-help interventions and control conditions, changes in depressive symptoms following self-help interventions, and differences in postintervention recovery and improvement rates between self-help interventions and control conditions were assessed in separate analyses. In treatment trials, depression scores continued to decrease from baseline to posttreatment and follow-up assessment in treatment subgroups. Changes in treatment subgroups' depression scores from baseline to postintervention assessment were greater relative to those observed in prevention subgroups. Self-help interventions produced larger overall effects on postpartum depression, relative to those observed in control conditions, in posttreatment (Hedges' g = 0.51) and follow-up (Hedges' g = 0.32) assessments; and self-help interventions were significantly more effective, relative to control conditions, in promoting recovery from postpartum depression. Effectiveness in preventing depression did not differ significantly between self-help interventions and control conditions.The findings suggested that self-help interventions designed to treat postpartum depression reduced levels of depressive symptoms effectively and decreased the risk of postpartum depression.
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Quality improvement strategies at primary care level to reduce inequalities in diabetes care: An equity-oriented systematic review
BACKGROUND: There is evidence that disparities exist in diabetes prevalence, access to diabetes care, diabetes-related complications, and the quality of diabetes care. A wide range of interventions has been implemented and evaluated to improve diabetes care. We aimed to review trials of quality improvement (QI) interventions aimed to reduce health inequities among people with diabetes in primary care and to explore the extent to which experimental studies addressed and reported equity issues. METHODS: Pubmed, EMBASE, CINAHL, and the Cochrane Library were searched to identify randomized controlled studies published between January 2005 and May 2016. We adopted the PROGRESS Plus framework, as a tool to explore differential effects of QI interventions across sociodemographic and economic factors. RESULTS: From 1903 references fifty-eight randomized trials met the inclusion criteria (with 17.786 participants), mostly carried out in USA. The methodological quality was good for all studies. Almost all studies reported the age, gender/sex and race distribution of study participants. The majority of trials additionally used at least one further PROGRESS-Plus factor at baseline, with education being the most commonly used, followed by income (55%). Large variation was observed between these studies for type of interventions, target populations, and outcomes evaluated. Few studies examined differential intervention effects by PROGRESS-plus factors. Existing evidence suggests that some QI intervention delivered in primary care can improve diabetes-related health outcomes in social disadvantaged population subgroups such as ethnic minorities. However, we found very few studies comparing health outcomes between population subgroups and reporting differential effect estimates of QI interventions. CONCLUSIONS: This review provides evidence that QI interventions for people with diabetes is feasible to implement and highly acceptable. However, more research is needed to understand their effective components as well as the adoption of an equity-oriented approach in conducting primary studies. Moreover, a wider variety of socio-economic characteristics such as social capital, place of residence, occupation, education, and religion should be addressed.
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Awareness, knowledge and views of off-label prescribing in children: A systematic review
AIM(S): To provide an updated overview of awareness, knowledge and views of off-label prescribing in children. METHOD: Literature search using electronic databases including PubMed, Medline, Scopus, Science Direct, Springer Link, Proquest, Ebsco Host and Google Scholar was conducted. Additional articles were identified by reviewing the bibliography of retrieved articles. The articles were searched with any of the Medical Subject Headings (MeSH) terms in the title: attitude, awareness, knowledge, experience, view, off-label, pediatric, paediatric and children. The inclusion criteria were full-text articles published in English between January 2004 and February 2015 and reported outcome related to awareness, knowledge and views regarding off-label prescribing in children. Editorials, reviews, notes, conference proceedings, letters and studies reporting prevalence of off-label prescribing were excluded. The articles were scrutinised using thematic analysis. RESULTS: 11 studies conducted among doctors, community pharmacists, paediatric nurses, parents and children met the inclusion criteria. Nine themes were developed through document analysis which includes main domains such as knowledge, awareness and views on off-label drug use in children, choice of information sources, reasons and suggestions to reduce off-label prescribing, concern regarding obtaining consent and participation in clinical trial. CONCLUSION: The studies reviewed reported that the majority of doctors and community pharmacists were familiar with the term off-label prescribing but knowledge among parents was low. Awareness on off-label prescribing in children remains low among all study participants. There is a mismatch between views on off-label prescribing in children of study participants and the finding of previous studies
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Comparative efficacy and safety of anticoagulant strategies for acute coronary syndromes. Comprehensive network meta-analysis of 42 randomised trials involving 117,353 patients
International guidelines differ in strengths of recommendation for anticoagulation strategies in acute coronary syndromes (ACS). We performed a comprehensive network meta-analysis (NMA) of randomised controlled trials (RCTs) to investigate the comparative efficacy and safety of parenteral anticoagulants in ACS. MEDLINE, Cochrane, EMBASE, Google Scholar, major cardiology websites, and abstracts/presentations were searched. Six treatments were identified: 1) unfractionated heparin (UFH) + glycoprotein IIb/IIIa inhibitor (GPI) [UFH+GPI], 2) UFH+/-GPI, 3) bivalirudin, 4) low-molecular-weight heparins (LMWHs), 5) otamixaban, and 6) fondaparinux. Prespecified outcomes (death, myocardial infarction [MI], revascularisation, major bleeding [MB], minor bleeding, and stent thrombosis [ST]) were evaluated up to 30 days. Forty-two RCTs involving 117,353 patients were included. No significant differences in mortality rates were found among strategies. Compared to UFH+GPI, bivalirudin reduced the odds of MB but increased the odds of ST and MI. LMWHs vs bivalirudin reduced MI risk at the price of MB excess. UFH+/-GPI significantly increased the odds of MI vs LMWHs, of ST vs UFH+GPI, and of MB vs bivalirudin. Reduced ST risk with otamixaban vs UFH+/-GPI and vs bivalirudin was offset by a marked 2.5- to four-fold MB excess. Fondaparinux showed an intermediate profile. Results for ST-segment elevation MI were consistent with the overall findings. Early anticoagulant strategies for ACS differ in efficacy and safety, with UFH+GPI and LMWHs reducing ischaemic but increasing bleeding risk, and bivalirudin reducing MB but increases MI and ST. The findings support individualised therapy based on patients' bleeding and ischaemic risks
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The Association between Leisure Time Physical Activity and Pancreatic Cancer Risk in Adults: A Systematic Review and Meta-Analysis
We conducted a meta-analysis of the association between leisure time physical activity (LTPA) and risk of pancreatic cancer to update previous analyses to examine subgroups of interest and potential sources of heterogeneity. We searched PubMed and MEDLINE databases for studies to February, 2015. Study information was collected using a standardized form to abstract relevant data on participant and study characteristics, assessment of LTPA and pancreatic cancer. We used random-effects models to pool estimates from included studies of lowest versus highest comparison of LTPA. The search identified 26 studies eligible for inclusion into the meta-analysis. The combined summary risk estimate was (RR, 0.89; 95% CI, 0.82-0.96). There was, evidence of heterogeneity across studies (I2=22.1%, P-heterogeneity=0.130). Some of the heterogeneity could be explained by study design, with stronger protective effects among case-control studies compared to cohort studies. Across study designs, age of population was a source of heterogeneity, with stronger effects observed among younger (<50 years of age) populations. The present meta-analysis supports a slightly protective association between LTPA and pancreatic cancer with an 11% risk reduction observed. LTPA appears to have the strongest effect among young populations and therefore investigations are needed to encourage increases in LTPA
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Effectiveness of community-based peer-led diabetes self-management programmes (COMP-DSMP) for improving clinical outcomes and quality of life of adults with diabetes in primary care settings in low and middle-income countries (LMIC): A systematic review and meta-analysis
INTRODUCTION: Globally, an estimated 380 million people live with diabetes today-80% in low-income and middle-income countries. The Middle East, Western Pacific, Sub-Saharan Africa and South-East Asia remain the most affected regions where economic development has transformed lifestyles, people live longer and there is an increase in the adult population. Although peer support has been used in different conditions with varied results, yet there is limited evidence to date supporting its effectiveness, particularly for individuals with diabetes. In this review, we will focus on community-based peer-led diabetes self-management programmes (COMP-DSMP) and examine the implementation strategies and diabetes-related health outcomes associated with them in LMIC primary healthcare settings. METHODS AND ANALYSIS: In accordance with reporting equity-focused systematic reviews PRISMA-P (preferred reporting items for systematic review and meta-analysis protocols 2015 checklist) guidelines, a systematic review with meta-analysis of randomised controlled trials (RCTs), non-randomised controlled trials, quasi-randomised controlled trials (CCTs) that involve contact with an individual or group of peers (paid or voluntary). Electronic searches will be performed in The Cochrane Library, MEDLINE, PubMed, SCOUPS, CINAHL and PsycINFO Database for the period January up to July 2000 along with manual searches in the reference lists of relevant papers. The analyses will be performed based on baseline data from RCTs, CCTs and preintervention and postintervention means or proportions will be reported for both intervention and control groups, and the absolute change from baseline will be calculated, together with 95% CIs. For dichotomous outcomes, the relative risk of the outcome will be presented compared to the control group. The risk difference will be calculated, which is the absolute difference in the proportions in each treatment group. ETHICS AND DISSEMINATION: Ethics is not required for this study, given that this is a protocol for a systematic review, which utilises published data. The findings of this study will be widely disseminated through peer-reviewed publications and conference presentations. TRIAL REGISTRATION NUMBER: PROSPERO (2014:CRD42014007531)
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