scholarly journals Responses to ARUBA: a systematic review and critical analysis for the design of future arteriovenous malformation trials

2017 ◽  
Vol 126 (2) ◽  
pp. 486-494 ◽  
Author(s):  
Elsa Magro ◽  
Jean-Christophe Gentric ◽  
Tim E. Darsaut ◽  
Daniela Ziegler ◽  
Michel W. Bojanowski ◽  
...  

OBJECTIVE The ARUBA study (A Randomized Trial of Unruptured Brain Arteriovenous Malformations [AVMs]) on unruptured brain AVMs has been the object of comments and editorials. In the present study the authors aim to systematically review critiques, discuss design issues, and propose a framework for future trials. METHODS The authors performed a systematic review of the French and English literature on the ARUBA study published between January 2006 and February 2015. The electronic search, including the Cochrane Library, MEDLINE (PubMed and Ovid), CINAHL, and EMBASE databases, was complemented by hand searching and cross-referencing. The comments were categorized as items related to the design, the conduct, and the analysis and interpretation of the trial. RESULTS Thirty-one articles or letters were identified. The pragmatic design, with heterogeneity of patients and lack of standardization of the treatment arm, were frequently stated concerns. The choice of outcome measures was repeatedly criticized. During the trial, low enrollment rates, selection bias, and premature interruption of enrollment were frequent comments. The short follow-up period, the lack of subgroup analyses, the lack of details on the results of the various treatments, and a contentious interpretation of results were noted at the analysis stage. A fundamental problem was the primary hypothesis testing conservative management. The authors believe that other trials are needed. Future trials could be pragmatic, test interventions stratified at the time of randomization, and look for long-term, hard clinical outcomes in a large number of patients. CONCLUSIONS In the authors' view, the ARUBA trial is a turning point in the history of brain AVM management; future trials should aim at integrating trial methodology and clinical care in the presence of uncertainty.

Diagnostics ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 552
Author(s):  
Salam Awenat ◽  
Arnoldo Piccardo ◽  
Patricia Carvoeiras ◽  
Giovanni Signore ◽  
Luca Giovanella ◽  
...  

Background: The use of prostate-specific membrane antigen (PSMA)-targeted agents for staging prostate cancer (PCa) patients using positron emission tomography/computed tomography (PET/CT) is increasing worldwide. We performed a systematic review on the role of 18F-PSMA-1007 PET/CT in PCa staging to provide evidence-based data in this setting. Methods: A comprehensive computer literature search of PubMed/MEDLINE and Cochrane Library databases for studies using 18F-PSMA-1007 PET/CT in PCa staging was performed until 31 December 2020. Eligible articles were selected and relevant information was extracted from the original articles by two authors independently. Results: Eight articles (369 patients) evaluating the role of 18F-PSMA-1007 PET/CT in PCa staging were selected. These studies were quite heterogeneous, but, overall, they demonstrated a good diagnostic accuracy of 18F-PSMA-1007 PET/CT in detecting PCa lesions at staging. Overall, higher primary PCa aggressiveness was associated with higher 18F-PSMA-1007 uptake. When compared with other radiological and scintigraphic imaging methods, 18F-PSMA-1007 PET/CT had superior sensitivity in detecting metastatic disease and the highest inter-reader agreement. 18F-PSMA-1007 PET/CT showed similar results in terms of diagnostic accuracy for PCa staging compared with PET/CT with other PSMA-targeted tracers. Dual imaging with multi-parametric magnetic resonance imaging and 18F-PSMA-1007 PET/CT may improve staging of primary PCa. Notably, 18F-PSMA-1007-PET/CT may detect metastatic disease in a significant number of patients with negative standard imaging. Conclusions: 18F-PSMA-1007 PET/CT demonstrated a good accuracy in PCa staging, with similar results compared with other PSMA-targeted radiopharmaceuticals. This method could substitute bone scintigraphy and conventional abdominal imaging for PCa staging. Prospective multicentric studies are needed to confirm these findings.


2021 ◽  
Author(s):  
Ahmed Al-Naher ◽  
Jennifer Downing ◽  
Kathryn A Scott ◽  
Munir Pirmohamed

BACKGROUND Adult chronic heart failure mainly affects an elderly population with multiple co-morbidities that often require frequent medical visits to prevent poor health outcomes. However the heart failure disease process reduces their independence by reducing mobility, exercise tolerance and cognitive decline. Remote care technologies can bridge the gap in care for these patients by allowing them to be followed up within the comfort of their home and encourage their self-care. However, patients, carers and healthcare professionals need to engage with the technology for it to be useful. OBJECTIVE This systematic review explored qualitative primary studies of remote care technologies used in heart failure, to determine the factors that affect user engagement with the technology. This is explored from the perspective of patients, carers, and healthcare professionals. METHODS Relevant studies published between 1/1/1990 – 19/9/2020 were identified from EMBASE, Ovid MEDLINE, Pubmed, Cochrane library and Scopus. These studies were then synthesized using thematic analysis. Relevant user experiences with remote care were extracted using line-by-line coding. These codes were summarised into secondary codes and core concepts, which were further merged into overarching themes that encapsulate user experience with remote care. RESULTS The review included 47 studies, which led to the generation of 5 overarching themes which affect engagement: (a) ‘Convenience’ relates to time saved by the intervention; (b) ‘Clinical Care’ relates to perceived quality of care and health outcomes; (c) ‘Communication’ involves feedback and interaction between patients, staff and carers; (d) ‘Education’ concerns the tailored information provided; and (e) ‘Ease of Use’ relates to accessibility and technical barriers to engagement. Each theme was applied to each user base of patient, carer and healthcare professional in a different manner. CONCLUSIONS The 5 themes identified highlight aspects of remote care that facilitate engagement, and should be considered in both future design and trials evaluating these technologies.


2019 ◽  
Vol 8 (1) ◽  
Author(s):  
Bridget Heijkoop ◽  
Natalie Parker ◽  
George Kiroff ◽  
Daniel Spernat

Abstract Background Venous thromboembolism (VTE) is a common postoperative complication associated with significant morbidity and mortality. The use of prophylactic heparin postoperatively reduces this risk, and the use of extended duration prophylaxis is becoming increasingly common. Malignancy and pelvic surgery both independently further increase the risk of postoperative VTE and patients undergoing major pelvic surgery for malignancy are at particularly high risk of VTE. However, the optimum duration of prophylaxis specifically in this population currently remains unclear. Methods We will conduct a systematic review of literature in accordance with the Cochrane Handbook for Systematic Reviews of Interventions (Higgins JPT, Green S. Cochrane Handbook for Systematic Reviews of Interventions version 5.1.0.,2011) to evaluate current evidence of the effectiveness and safety of inpatient versus extended VTE prophylaxis with heparin (all forms) following major pelvic surgery for malignancy. We will search PubMed, EMBASE, and the Cochrane Library. Regarding safety, Food and Drug Administration (FDA), and Therapeutic Goods Administration (TGA) websites will be searched, including all levels of evidence. Results will be the postoperative timeframe in which a VTE event can be considered to have been provoked by the surgery, and the number of patients needed to treat with both inpatient and extended prophylaxis to prevent a VTE event in this timeframe, comparing these to determine if there is a significant benefit from extended prophylaxis. Discussion This systematic review will aim to identify the postoperative period in which patients undergoing major pelvic surgery for malignancy are at further increased risk of VTE as a result of their surgery and the optimum duration of heparin VTE prophylaxis with heparin to reduce this risk. Determining this will allow evidence-based recommendations to be made for the optimum duration of heparin VTE prophylaxis post major pelvic surgery for malignancy, leading to improved standards of care that are consistent between different providers and institutions. Systematic review registration In accordance with guidelines, our systematic review was submitted to PROSPERO for consideration of registration on 16/12/17 and was registered on 12/1/18 with the registration number CRD42018068961, and it was last updated on December 1, 2018.


2019 ◽  
pp. bmjspcare-2019-001952 ◽  
Author(s):  
Sepide Rezaei ◽  
Saba Ahmadi ◽  
Jeiran Rahmati ◽  
Hossein Hosseinifard ◽  
Afsaneh Dehnad ◽  
...  

IntroductionThe incidence of some fatal diseases, including HIV/AIDS, accompanied by depression has become a significant concern in developed, developing and underdeveloped countries. A great deal of time and money are spent on controlling and reducing the complications of this infection across the world. Accordingly, the main purpose of this study was to clarify the global prevalence rate of depression in patients living with HIV/AIDS via a systematic review and meta-analysis.MethodologyAll articles in English, published between 2000 and 2018, were systematically searched from the original databases of Web of Science, PubMed, Scopus, Cochrane Library, Google Scholar and Embase. As a result, a total of 118 articles were identified.ResultsThe total sample size in these articles was 51143 people, and the number of patients suffering from moderate and severe levels of depression was 14 942. The results of the analysis based on the random-effects (DerSimonian and Laird) model revealed that the prevalence rate of depression in patients with HIV/AIDS was 31% (95% CI 28% to 34%), with a 98% heterogeneity index which was reported significant. Meanwhile, the highest prevalence rate of depression based on continent was in South America at 44% (95% CI 35% to 53%) and the lowest rate was in Europe at 22% (95% CI 17% to 27%).ConclusionIn general, there was a higher prevalence rate of depression in developing and underdeveloped countries than in developed countries, which could be attributed to the advancement of science and the possibilities for early diagnosis of this syndrome.Trial registration numberCRD42019119137.


Blood ◽  
2005 ◽  
Vol 106 (11) ◽  
pp. 5160-5160
Author(s):  
Miles Prince ◽  
Michael Adena ◽  
Dell Kingsford Smith ◽  
Judy Hertel

Abstract Aim: To perform a systematic review of the efficacy of monotherapy with bortezomib versus thalidomide in patients with relapsed or refractory multiple myeloma. Methods: Published English literature from 1966 to June 2005 (MEDLINE, EMBASE, Cochrane library), publication reference lists, Janssen-Cilag Pty Ltd data-on-file, and abstracts from recent multiple myeloma conferences were reviewed. Prospective studies containing at least a single arm of any treatment group with n ≥ 30 and using continuing or variable thalidomide dosing were included. Studies adding dexamethasone for non-responders were excluded. Outcomes were analysed on an intent-to-treat basis. Statistical pooling was performed where possible for the following outcome measures: primary outcome of response rate, defined by a serum M-protein reduction ≥50% (A) and strict (e.g. EBMT) criteria (B), and for the secondary outcomes of overall survival and progression-free survival. Results: One bortezomib (n=333, APEX, NEJM2005, 352; 2487–98) and 15 thalidomide (n=1007) studies were included. Patient baseline characteristics including age, gender, IgG:IgA, disease duration and β2M were well matched, except that 48% of bortezomib patients had received prior thalidomide. On an intent-to-treat basis, the overall estimate for response rate (A) was 53% for patients receiving bortezomib versus 32% for thalidomide (p<0.001, n=10 studies). For response rate (B) the estimate was 36% for patients receiving bortezomib versus 22% for thalidomide (p<0.001, n=4 studies). One-year survival was 81% for patients receiving bortezomib versus 67% for thalidomide (p<0.001, n=6 studies). Due to differences in disease monitoring and definitions of progression, it was not possible to compare results for progression-free survival. Conclusion: In patients with relapsed or refractory multiple myeloma, bortezomib achieved significantly higher response rates and longer one-year survival than thalidomide, despite 48% of bortezomib-treated patients having received prior thalidomide.


2021 ◽  
Vol 9 ◽  
Author(s):  
Xia Gao ◽  
Yan Wang ◽  
Zichuan Xu ◽  
Huiying Deng ◽  
Huabin Yang ◽  
...  

Objective: To explore the effectiveness and safety of rituximab (RTX) for steroid-dependent or frequently relapsing nephrotic syndrome via a systematic review and meta-analysis.Methods: All the literature about RTX therapy for childhood nephrotic syndrome (NS) on PubMed, Web of Science, Cochrane Library, EMBASE, and Chinese biomedical literature database published before November 1, 2019, were conducted and selected according to the preset criteria. The Cochrane bias risk assessment tool was used to evaluate the quality of the literature included. The outcome data were analyzed by RevMan 5.3 software.Results: There were six RCT studies that met the inclusion criteria with a moderate quality after evaluation. At the end of the treatment, the relapse rate of NS in the RTX group reduced significantly when compared with that in the control group [odds ratio (OR) = 0.11, 95% confidence interval (CI) (0.03, 0.43), p = 0.001]. The number of patients in the RTX group used less steroid or/and calcineurin inhibitors significantly than that in the control group [OR = 0.05, 95% CI (0.01, 0.28), p = 0.0007]. For children who were steroid-dependent, RTX treatment significantly reduced the dosage of the steroid, compared with that in control [standardized mean difference (SMD) = −1.49, 95% CI (−2.00, −0.99), p < 0.00001]. There was no significant reduction in protein excretion between the two groups [SMD = −0.33, 95% CI (−0.71, 0.04), p = 0.08]. Fewer serious adverse reactions of RTX in the six studies were reported and most adverse events were mild.Conclusion: RTX is effective and safe for children with steroid-dependent or frequently relapsing nephrotic syndrome.Systematic Review Registration: Identifier: CRD 42020150933. https://www.crd.york.ac.uk/prospero/. This review has been registered to the PROSPERO on 27 Feb 2020.


2020 ◽  
pp. 1357633X2091781
Author(s):  
Chuqing Zhou ◽  
Hua Hu ◽  
Chunyi Wang ◽  
Ziyu Zhu ◽  
Gengchen Feng ◽  
...  

Introduction Postpartum depression (PPD) is a common psychiatric condition during the postnatal period that negatively impacts the well-being of both the mother and her infant. This study describes a systematic review and preliminary meta-analysis to assess the efficacy of mobile health (mHealth) interventions, which is defined as the use of portable electronic devices to support public health and medical practice, in addressing depressive symptoms among postpartum women. Methods Databases including PubMed, PsycINFO, the Cochrane Library, Embase and ClinicalTrials.gov were searched for randomized controlled trials (RCTs) assessing the effectiveness of mHealth interventions on PPD from database inception to December 2019. Results The initial search identified 754 studies, of which, 11 studies fulfilled the inclusion criteria. These studies evaluated four types of distinct mHealth interventions and involved 2424 participants across six countries. Pooled results demonstrated that compared to the controls, the Edinburgh Postnatal Depression Scale score decreased in the mHealth intervention group (mean difference: –1.09, 95% confidence interval: –1.39 to –0.79). Discussion Our study suggested that mHealth interventions may be a promising tool to complement routine clinical care in the prevention and treatment of PPD, but the clinical effectiveness of mHealth interventions needs to be better established. While most studies focused on telephone-based interventions, recent researches have also suggested the superiority and effectiveness of short messaging service (SMS) and smartphone applications, but the exact efficacy needs further evaluation. Therefore, more high-quality RCTs on app-based and SMS-based interventions are needed before the large-scale roll-out of these interventions in clinical practice.


2020 ◽  
Vol 15 (1) ◽  
Author(s):  
Shiqi Zhu ◽  
Yu Wang ◽  
Peng Yin ◽  
Qingjun Su

Abstract Purpose The surgical treatment of thoracic myelopathy is still controversial and also a challenge for spine surgeons. Therefore, the objective of this study was to review the related literature on the surgical treatment of thoracic myelopathy and try to define treatment guidelines for spine surgeons on thoracic myelopathy. Methods Relevant literatures were searched based on the PubMed, EMBASE, and Cochrane Library between January 2008 and December 2018. Some data on the characteristics of patients were extracted, including number of patients, mean age, surgical procedures, blood loss, complications, and pre-/post-operation modified JOA score. Recovery rate was used to assess the effect of surgery outcome, and the safety was evaluated by blood loss and incidence of complications. Results Thirty-five studies met the inclusion criteria and were retrieved. A total of 2183 patients were included in our systematic review, with the average age of 55.2 years. There were 69.8% patients diagnosed as ossification of ligamentum flavum (OLF), 20.0% as ossification of posterior longitudinal ligament (OPLL), 9.3% as disk herniation (DH), and 0.9% as others including diffuse idiopathic skeletal hyperostosis (DISH) and ankylosing spondylitis (AS). The volume of blood loss was more in the treatment of circumferential decompression (CD) than posterior decompression (PD), and the incidence of complications was higher in CD (P < 0.05). The volume of blood loss in minimally invasive surgery (MIS) was lowest and the incidence of complications was 19.2%. Post-operation recovery rate was 0.49 in PD, 0.35 in CD, and 0.29 in MIS while the recovery rate was 0.54 in PD, 0.55 in CD, and 0.49 in MIS at the last follow-up. When focusing on the OLF specifically, incidence of complications in PD was much lower than CD, with less blood loss and higher recovery rate. Focusing on the OPLL specifically, incidence of complications in PD was much lower than CD, with less blood loss while there was no statistical difference in recovery rate between these two methods. Conclusions This systematic review showed that posterior decompression for thoracic myelopathy is safer and better than circumferential decompression according to the complication rate and surgical outcome. And we should also consider the location of compression before the operation.


Blood ◽  
2018 ◽  
Vol 132 (Supplement 1) ◽  
pp. 3239-3239
Author(s):  
Muhammad Usman ◽  
Warda Faridi ◽  
Muhammad Asad Fraz ◽  
Muhammad Junaid Tariq ◽  
Saad Ullah Malik ◽  
...  

Abstract Introduction: Survival of patients with multiple myeloma (MM) has improved over the last decade, mainly due to advent of newer drugs, three drug based induction, high dose chemotherapy consolidation and routine use of maintenance therapy for eligible patients. Despite advances in therapy, many cases of MM ultimately relapse and there is need to summarize evidence comparing efficacy and clinical outcome of combination regimens used in relapsed or refractory MM (RRMM) treatment. We performed a systematic review and meta-analysis of randomized controlled trials to compare the efficacy of lenalidomide based three drug regimens versus two drug regimens among relapsed and refractory myeloma (RRMM) patients. Methods: We conducted a literature search on PubMed, Embase, Wiley Cochrane Library, Web of Science and ClinicalTrials.gov which was completed on March 26, 2018. We used keywords like "relapsed multiple myeloma", "revlimid", "dexamethasone", "elotuzumab", "carfilzomib", "bortezomib", "ixazomib", "daratumumab", "doxorubicin", "pembrolizumab", "thalidomide", "cyclophosphamide" along with MeSH and Emtree terms. The primary meta-analytic approach was a random effects model using the Mantel-Haenszel method. It was used to calculate pooled risk ratio of objective response rates with 95% confidence interval. Cochrane Collaboration's tool was used for quality assessment of included studies. Systematic reviews, meta-analyses, combination regimen without lenalidomide, newly diagnosed MM patients, and other plasma cell dyscrasias were excluded. Results: Literature search retrieved 11,362 titles. Following initial screening, 72 articles were considered for full text review. Of these only five studies with 2844 patients met inclusion criteria and two studies qualified for meta-analysis. The study arm used daratumumab (Dara), ixazomib, carfilzomib, or elotuzumab in combination with lenalidomide (Len) and dexamethasone (Dex). The control arm used combination of Len and Dex (LenD). There was no difference in overall response rate (ORR) between ixazomib-Len-Dex regimen versus LenD (RR=1.33, 95% CI = 0.83 to 2.17, p= 0.236). However significantly higher complete response (CR) was observed in ixazomib-Len-Dex group compared to LenD (RR = 1.82, 95% CI = 1.14 to 2.93, p = 0.013). An absolute increase in ORR among carfilzomib-Len-Dex, elotuzumab-Len-Dex, and daratumumab-Len-Dex versus LenD was 20.4% (87.1% vs. 66.7%, p <0.001), 13% (79% vs 66%, p <0.001) and 16.5% (92.9% vs. 76.4%, p <0.001) respectively. Conclusion: Daratumumab and carfilzomib in Len based three drug regimens have better clinical efficacy when compared to lenalidomide and dexamethasone based two drug regimens among relapsed and refractory multiple myeloma patients. There was no difference between the ORR of ixazomib based combination regimen and LenD but higher number of patients achieved deeper responses. Disclosures No relevant conflicts of interest to declare.


2021 ◽  
Author(s):  
Kelly Lloyd ◽  
Louise Hall ◽  
Natalie King ◽  
Rachael Thorneloe ◽  
Rocio Rodriguez ◽  
...  

Background: Clinical guidelines worldwide are increasingly recommending aspirin for cancer prevention. We undertook a systematic review to synthesise the quantitative and qualitative data on attitudes and behaviour towards the use of aspirin for cancer prevention, and healthcare providers’ attitudes and behaviour towards implementing aspirin in clinical care.Design: In February 2020, we searched: MEDLINE, EMBASE, CINAHL, Web of Science, Cochrane Library, DARE, NHS EED, HTA Database, clinical trial registries and ProQuest Dissertations &amp; Theses. Peer-reviewed studies on the use of aspirin for cancer prevention were included. We used the Mixed Methods Appraisal Tool to evaluate study quality, and conducted a narrative synthesis of the data. The review was pre-registered (PROSPERO: CRD42018093453).Results: Forty-two studies were identified. Uptake and adherence data were all from trials. Trials recruited healthy participants, those at higher risk of cancer (e.g. colorectal), and those with cancer (e.g. breast, colorectal). Four trials reported uptake data, of which three found low to medium uptake rates (3.7-40.9%). Most trials (18/22) reported high day-to-day adherence (≥80%). Among trials reporting data at three years, 38.6-93.6% were still using aspirin at follow-up. Four studies investigated the factors associated with adherence, and none with uptake. Three trials observed no association between gender and adherence levels. One trial found no association between colorectal cancer risk and adherence levels. Three studies observed low rates (3.2-34.5%) of healthcare providers recommending aspirin in clinical practice. No qualitative studies were identified. Conclusion: Most patients and members of the public who are offered aspirin for cancer prevention do not initiate preventive therapy. Day-to-day adherence was high among those using aspirin, but persistence may be a problem where long-term use is required. Further research is needed to identify the factors affecting aspirin use, and the barriers to implementing aspirin into clinical care.


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