scholarly journals Outcomes evaluated in controlled clinical trials on the management of COVID-19: A methodological systematic review

2020 ◽  
Author(s):  
Alexander G. Mathioudakis ◽  
Markus Fally ◽  
Rola Hashad ◽  
Ahmed Kouta ◽  
Ali Sina Hadi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Outcome Measurement ◽  
Treatment Success ◽  
Community Setting ◽  
Significant Heterogeneity ◽  
Measurement Instruments ◽  
Life Saving

AbstractIt is crucial that randomized controlled trials (RCTs) on the management of coronavirus disease 2019 (COVID-19) evaluate the outcomes that are critical to patients and clinicians, to facilitate relevance, interpretability, and comparability.This methodological systematic review describes the outcomes evaluated in 415 RCTs on the management of COVID-19, that were registered with ClinicalTrials.gov, by 5/5/2020.Significant heterogeneity was observed in the selection of outcomes and the instruments used to measure them. Mortality, adverse events and treatment success or failure are only evaluated in 64.4%, 48.4% and 43% of the included studies, respectively, while other outcomes are selected less often. Studies focusing on more severe presentations (hospitalized patients or requiring intensive care) most frequently evaluate mortality and adverse events, while hospital admission and viral detection/load are most frequently assessed in the community setting. Outcome measurement instruments are poorly reported and heterogeneous. In general, simple instruments that can control for important sources of bias are favoured. Follow-up does not exceed one month in 64.3% of these earlier trials, and long-term COVID-19 burden is rarely assessed.The methodological issues identified could delay the introduction of potentially life-saving treatments in clinical practice. Our findings demonstrate the need for consensus in the design of RCTs.Take home message@ERSpublications: This systematic review describes the heterogeneity in outcomes evaluated in 415 RCTs on COVID-19 management and the instruments used to measure them. Our findings reveal a need for consensus in the design of future RCTs.

scholarly journals Outcomes Evaluated in Controlled Clinical Trials on the Management of COVID-19: A Methodological Systematic Review

Life ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. 350
Author(s):  
Alexander G. Mathioudakis ◽  
Markus Fally ◽  
Rola Hashad ◽  
Ahmed Kouta ◽  
Ali Sina Hadi ◽  
...  
Keyword(s):  
Systematic Review ◽  
Adverse Events ◽  
Outcome Measurement ◽  
Treatment Success ◽  
Community Setting ◽  
Significant Heterogeneity ◽  
Measurement Instruments ◽  
Life Saving ◽  
Compare And Contrast

It is crucial that randomized controlled trials (RCTs) on the management of coronavirus disease 2019 (COVID-19) evaluate the outcomes that are critical to patients and clinicians, to facilitate relevance, interpretability, and comparability. This methodological systematic review describes the outcomes evaluated in 415 RCTs on the management of COVID-19, that were registered with ClinicalTrials.gov, by 5 May 2020, and the instruments used to measure these outcomes. Significant heterogeneity was observed in the selection of outcomes and instruments. Mortality, adverse events and treatment success or failure are only evaluated in 64.4%, 48.4% and 43% of the included studies, respectively, while other outcomes are selected less often. Studies focusing on more severe presentations (hospitalized patients or requiring intensive care) most frequently evaluate mortality (72.5%) and adverse events (55.6%), while hospital admission (50.8%) and viral detection/load (55.6%) are most frequently assessed in the community setting. Outcome measurement instruments are poorly reported and heterogeneous. Follow-up does not exceed one month in 64.3% of these earlier trials, and long-term COVID-19 burden is rarely assessed. The methodological issues identified could delay the introduction of potentially life-saving treatments in clinical practice. Our findings demonstrate the need for greater consistency, to enable decision makers to compare and contrast studies.

scholarly journals Prevalence and progression of incidental terminal ileitis on non-diagnostic colonoscopy: a systematic review and meta-analysis

2021 ◽  
Author(s):  
Manasi Agrawal ◽  
Mario Bento-Miranda ◽  
Samantha Walsh ◽  
Neeraj Narula ◽  
Jean-Frederic Colombel ◽  
...  
Keyword(s):  
Systematic Review ◽  
Prevalence Rate ◽  
Meta Analysis ◽  
Significant Heterogeneity ◽  
Long Term Outcomes ◽  
Diagnostic Colonoscopy ◽  
Terminal Ileitis ◽  
Pooled Prevalence

Abstract Background Incidentally-diagnosed terminal ileitis (IDTI) has been reported among asymptomatic persons undergoing non-diagnostic colonoscopy. The purpose of our study was to determine the prevalence and long-term outcomes of asymptomatic terminal ileitis. Methods We performed a systematic review using three biomedical databases (Medline, Embase and Web of Science) and relevant scientific meeting abstracts. We identified observational studies that reported the prevalence of IDTI in adults undergoing screening or polyp surveillance colonoscopy and/or the long-term outcomes of such lesions. A random-effects meta-analysis was conducted to determine the pooled prevalence rate of IDTI. The progression of IDTI to overt Crohn’s disease (CD) was also described. Results Of 2,388 eligible studies, 1,784 were screened after excluding duplicates, 84 were reviewed in full text, and 14 studies were eligible for inclusion. Seven studies reported the prevalence of IDTI in 44,398 persons undergoing non-diagnostic colonoscopy, six studies reported follow-up data, and one study reported both types of data. The pooled prevalence rate of IDTI was 1.6% (CI 0.1–21.8%) with significant heterogeneity (I 2 = 99.7). Among patients who had undergone non-diagnostic colonoscopy and had follow-up data (range 13–84 months reported in five studies), progression to overt CD was rare. Conclusion IDTI is not uncommon on non-diagnostic colonoscopies. Based on limited data, the rate of its progression to overt CD seems low, and watchful waiting is likely a reasonable strategy. Further long-term follow-up studies are needed to inform the natural history of incidental terminal ileitis, factors that predict progression to CD, and therapeutic implications.

Long-term results and comparison of flow re-direction endoluminal device and pipeline embolization device in endovascular treatment of intracranial carotid aneurysms

2021 ◽  
pp. 159101992110307
Author(s):  
Cemal A Gündoğmuş ◽  
Soheil Sabet ◽  
Nurten A Baltacıoğlu ◽  
Derya Türeli ◽  
Yaşar Bayri ◽  
...  
Keyword(s):  
Adverse Events ◽  
Treatment Success ◽  
Long Term Results ◽  
Pipeline Embolization Device ◽  
Mortality And Morbidity ◽  
Significant Difference ◽  
Aneurysm Occlusion ◽  
Carotid Aneurysms

Objective This study aims to compare the efficacy, safety, and long-term outcomes of two flow diverters, i.e., pipeline embolization device and flow re-direction endoluminal device, in the treatment of distal carotid aneurysms. Methods A total of 138 patients with 175 aneurysms were included from February 2012 to September 2019. Ninety-nine aneurysms were treated with flow re-direction endoluminal device and 76 with pipeline embolization device. Angiographic follow-ups were at the 6th, 12th, 24th, 36th, and 60th months; the O’Kelly-Marotta grading scale was used to assess aneurysms occlusion. Outcomes of two devices were compared; possible associations regarding patient characteristics, aneurysm properties, treatment details, and adverse events were evaluated. Results The mean follow-up period was 33 months, with 10 patients lost to follow-up. Occlusion rates at the 6th and 12th months and during the last follow-up were similar for flow re-direction endoluminal device (81%, 84%, and 90%) and pipeline embolization device (82%, 85%, and 93%). Occlusion rates were also similar after stand-alone use without coiling. There was no significant difference regarding adverse event rates with a 10.9% overall complication rate, 3.6% mortality, and 0.7% permanent morbidity. All the mortality and morbidity were related to hemorrhagic complications. Device deployment failure was observed with five flow re-direction endoluminal devices and two pipeline embolization devices, whereas two severe in-stent stenoses occurred with each device. Conclusions Both flow re-direction endoluminal device and pipeline embolization device are feasible and effective in flow diversion of distal internal carotid artery aneurysms, with similar adverse events rates and aneurysm occlusion success. Aneurysm occlusion rates increase with time, while the presence of an integrated branch significantly decreases treatment success.

scholarly journals Long-term and serious harms of medical cannabis and cannabinoids for chronic pain: A systematic review of non-randomized studies

2021 ◽  
Author(s):  
Dena Zeraatkar ◽  
Matthew Cooper ◽  
Arnav Agarwal ◽  
Robin Vernooij ◽  
Gareth Leung ◽  
...  
Keyword(s):  
Systematic Review ◽  
Chronic Pain ◽  
Adverse Events ◽  
Cochrane Central Register ◽  
Medical Cannabis ◽  
Management Options ◽  
Serious Adverse Events ◽  
Randomized Studies

Objective: To establish the risk and prevalence of long-term and serious harms of medical cannabis and cannabinoids for chronic pain. Design: Systematic review and meta-analysis. Data sources: MEDLINE, EMBASE, PsycInfo, and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception to April 1, 2020. Study selection: Non-randomized studies reporting on harms of medical cannabis or cannabinoids in people living with chronic pain with ≥4 weeks of follow-up. Data extraction and synthesis: A parallel guideline panel provided input on the design and interpretation of the systematic review, including selection of adverse events for consideration. Two reviewers, working independently and in duplicate, screened the search results, extracted data, and assessed risk of bias. We used random-effects models for all meta-analyses and the GRADE approach to evaluate the certainty of evidence. Results: We identified 39 eligible studies that enrolled 12,143 patients with chronic pain. Very low certainty evidence suggests that adverse events are common (prevalence: 26.0%; 95% CI 13.2 to 41.2) among users of medical cannabis or cannabinoids for chronic pain, particularly any psychiatric adverse events (prevalence: 13.5%; 95% CI 2.6 to 30.6). However, very low certainty evidence indicates serious adverse events, adverse events leading to discontinuation, cognitive adverse events, accidents and injuries, and dependence and withdrawal syndrome are uncommon and typically occur in fewer than one in 20 patients. We compared studies with <24 weeks and ≥ 24 weeks cannabis use and found more adverse events reported among studies with longer follow-up (test of interaction p < 0.01). Palmitoylethanolamide was usually associated with few to no adverse events. We found insufficient evidence addressing the harms of medical cannabis compared to other pain management options, such as opioids. Conclusions: There is very low certainty evidence that adverse events are common among people living with chronic pain who use medical cannabis or cannabinoids, but that few patients experience serious adverse events. Future research should compare long-term and serious harms of medical cannabis with other management options for chronic pain, including opioids.

scholarly journals Efficacy and Safety of Probiotics, Prebiotics and Synbiotics in the Treatment of Irritable Bowel Syndrome: A systematic review and meta-analysis

2020 ◽  
Vol 20 (1) ◽  
pp. 13 ◽  
Author(s):  
Mohammad Z. Asha ◽  
Sundos F. H. Khalil
Keyword(s):  
Systematic Review ◽  
Irritable Bowel Syndrome ◽  
Adverse Events ◽  
Meta Analysis ◽  
Group Differences ◽  
Significant Heterogeneity ◽  
Efficacy And Safety ◽  
Gastrointestinal Microbiome ◽  
Irritable Bowel

Treatments that target alterations in gut microbiota may be beneficial for patients with irritable bowel syndrome (IBS). A systematic review and meta-analysis was conducted of randomised clinical trials (RCTs) evaluating the efficacy and safety of probiotics, prebiotics and synbiotics. Factors considered in the analysis included global IBS symptoms and/or abdominal pain, secondary symptoms and the frequency of adverse events. A total of 33 RCTs involving 4,321 patients were identified. Overall, probiotics significantly improved global IBS symptoms compared to placebos (standardised mean difference = −0.32, 95% confidence interval: −0.48 to −0.15; P <0.001), with significant heterogeneity between studies (I2 = 72%; P <0.001). This remained apparent in both single- and multi-strain probiotic interventions as well as synbiotic formulations. However, evidence regarding prebiotics was scarce. There were no significant inter-group differences in terms of the frequency of adverse events. Future RCTs should address methodological limitations, including short follow-up periods and patient adherence.Keywords: Irritable Bowel Syndrome; Gastrointestinal Microbiome; Dietary Supplements; Probiotics; Prebiotics; Synbiotics; Meta-Analysis; Systematic Review.

scholarly journals Update on Noma: systematic review on classification, outcomes and follow-up of patients undergoing reconstructive surgery after Noma disease

BMJ Open ◽  
2021 ◽  
Vol 11 (8) ◽  
pp. e046303
Author(s):  
Sophie Speiser ◽  
Benjamin Langridge ◽  
Moira Melina Birkl ◽  
Harald Kubiena ◽  
Will Rodgers
Keyword(s):  
Systematic Review ◽  
Reconstructive Surgery ◽  
Outcome Measurement ◽  
Healthcare Delivery ◽  
Mouth Opening ◽  
Classification Systems ◽  
Neglected Diseases ◽  
Complication Rates

IntroductionNoma is a significant yet neglected disease which affects some of the least developed countries in the world. The long-term benefit and safety of Noma surgical reconstructive missions have recently been under scrutiny due to a perceived lack of measurable outcomes and appropriate follow-up. This study analyses and reports on classifications, outcome measurement tools and follow-up for reconstructive surgery after Noma disease.MethodsThis systematic review was undertaken following Preferred Reporting Items for Systematic Reviews and Meta-analyses guidelines. The three medical databases Medline, EMBASE and Web of Sciences were searched, articles published between 1 January 1983 and 15 April 2020 were included. All primary evidence on reconstructive surgery following Noma disease, reporting data on outcome after surgery, follow-up time and complications were included. Extracted data were aggregated to generate overall and population corrected mean outcomes and complication rates.ResultsOut of 1393 identified records, 31 studies including 1110 Noma patients were analysed. NOITULP and Montandon/WHO were the most commonly used classification systems. Mouth opening (MO) and complication rates were the two most often reported outcomes. Overall mean complication rate was 44%, reported by 24 studies. Postoperative MO was reported by eight publications, of which, five reported long-term outcomes (>12 months). Mean MO improved by 20 mm when compared with mean population weighted preoperative MO (7 mm). At long-term follow-up, MO decreased to 20 mm.ConclusionsStudies reporting on neglected diseases in developing countries often lack methodological rigour. Surgeons should be mindful during patient examination by using a classification system that allows to compare preoperative versus postoperative state of disease. Short-term mission surgery is a vital part of healthcare delivery to underdeveloped and poor regions. Future missions should aim at sustainable partnerships with local healthcare providers to ensure postoperative care and long-term patient-oriented follow-up. A shift towards a diagonal treatment delivery approach, whereby local surgeons and healthcare staff are educated and empowered, should be actively promoted.PROSPERO registration numberCRD42020181931.

Mechanical thrombectomy in pediatric stroke: systematic review, individual patient data meta-analysis, and case series

2019 ◽  
Vol 24 (5) ◽  
pp. 558-571 ◽  
Author(s):  
Kartik Bhatia ◽  
Hans Kortman ◽  
Christopher Blair ◽  
Geoffrey Parker ◽  
David Brunacci ◽  
...  
Keyword(s):  
Systematic Review ◽  
Ischemic Stroke ◽  
Acute Ischemic Stroke ◽  
Mechanical Thrombectomy ◽  
Case Reports ◽  
Meta Analysis ◽  
Case Series ◽  
Neurological Outcomes

OBJECTIVEThe role of mechanical thrombectomy in pediatric acute ischemic stroke is uncertain, despite extensive evidence of benefit in adults. The existing literature consists of several recent small single-arm cohort studies, as well as multiple prior small case series and case reports. Published reports of pediatric cases have increased markedly since 2015, after the publication of the positive trials in adults. The recent AHA/ASA Scientific Statement on this issue was informed predominantly by pre-2015 case reports and identified several knowledge gaps, including how young a child may undergo thrombectomy. A repeat systematic review and meta-analysis is warranted to help guide therapeutic decisions and address gaps in knowledge.METHODSUsing PRISMA-IPD guidelines, the authors performed a systematic review of the literature from 1999 to April 2019 and individual patient data meta-analysis, with 2 independent reviewers. An additional series of 3 cases in adolescent males from one of the authors’ centers was also included. The primary outcomes were the rate of good long-term (mRS score 0–2 at final follow-up) and short-term (reduction in NIHSS score by ≥ 8 points or NIHSS score 0–1 at up to 24 hours post-thrombectomy) neurological outcomes following mechanical thrombectomy for acute ischemic stroke in patients < 18 years of age. The secondary outcome was the rate of successful angiographic recanalization (mTICI score 2b/3).RESULTSThe authors’ review yielded 113 cases of mechanical thrombectomy in 110 pediatric patients. Although complete follow-up data are not available for all patients, 87 of 96 (90.6%) had good long-term neurological outcomes (mRS score 0–2), 55 of 79 (69.6%) had good short-term neurological outcomes, and 86 of 98 (87.8%) had successful angiographic recanalization (mTICI score 2b/3). Death occurred in 2 patients and symptomatic intracranial hemorrhage in 1 patient. Sixteen published thrombectomy cases were identified in children < 5 years of age.CONCLUSIONSMechanical thrombectomy may be considered for acute ischemic stroke due to large vessel occlusion (ICA terminus, M1, basilar artery) in patients aged 1–18 years (Level C evidence; Class IIb recommendation). The existing evidence base is likely affected by selection and publication bias. A prospective multinational registry is recommended as the next investigative step.

Exercise interventions in lateral elbow tendinopathy have better outcomes than passive interventions, but the effects are small: a systematic review and meta-analysis of 2123 subjects in 30 trials

2020 ◽  
pp. bjsports-2020-102525
Author(s):  
Stefanos Karanasios ◽  
Vasileios Korakakis ◽  
Rod Whiteley ◽  
Ioannis Vasilogeorgis ◽  
Sarah Woodbridge ◽  
...  
Keyword(s):  
Systematic Review ◽  
Meta Analysis ◽  
Risk Of Bias ◽  
Short Term ◽  
Lateral Elbow ◽  
Long Term Follow Up ◽  
Wait And See ◽  
Lateral Elbow Tendinopathy

ObjectiveTo evaluate the effectiveness of exercise compared with other conservative interventions in the management of lateral elbow tendinopathy (LET) on pain and function.DesignSystematic review and meta-analysis.MethodsWe used the Cochrane risk-of-bias tool 2 for randomised controlled trials (RCTs) to assess risk of bias and the Grading of Recommendations Assessment, Development and Evaluation methodology to grade the certainty of evidence. Self-perceived improvement, pain intensity, pain-free grip strength (PFGS) and elbow disability were used as primary outcome measures.Eligibility criteriaRCTs assessing the effectiveness of exercise alone or as an additive intervention compared with passive interventions, wait-and-see or injections in patients with LET.Results30 RCTs (2123 participants, 5 comparator interventions) were identified. Exercise outperformed (low certainty) corticosteroid injections in all outcomes at all time points except short-term pain reduction. Clinically significant differences were found in PFGS at short-term (mean difference (MD): 12.15, (95% CI) 1.69 to 22.6), mid-term (MD: 22.45, 95% CI 3.63 to 41.3) and long-term follow-up (MD: 18, 95% CI 11.17 to 24.84). Statistically significant differences (very low certainty) for exercise compared with wait-and-see were found only in self-perceived improvement at short-term, pain reduction and elbow disability at short-term and long-term follow-up. Substantial heterogeneity in descriptions of equipment, load, duration and frequency of exercise programmes were evident.ConclusionsLow and very low certainty evidence suggests exercise is effective compared with passive interventions with or without invasive treatment in LET, but the effect is small.PROSPERO registration numberCRD42018082703.

scholarly journals Long-term outcomes of psychological treatment for posttraumatic stress disorder: a systematic review and meta-analysis

2021 ◽  
pp. 1-11
Author(s):  
Maxi Weber ◽  
Sarah Schumacher ◽  
Wiebke Hannig ◽  
Jürgen Barth ◽  
Annett Lotzin ◽  
...  
Keyword(s):  
Systematic Review ◽  
Depressive Symptoms ◽  
Stress Disorder ◽  
Psychological Treatment ◽  
Meta Analysis ◽  
Effect Sizes ◽  
Long Term Outcomes ◽  
Psychological Treatments

Abstract Several types of psychological treatment for posttraumatic stress disorder (PTSD) are considered well established and effective, but evidence of their long-term efficacy is limited. This systematic review and meta-analysis aimed to investigate the long-term outcomes across psychological treatments for PTSD. MEDLINE, Cochrane Library, PTSDpubs, PsycINFO, PSYNDEX, and related articles were searched for randomized controlled trials with at least 12 months of follow-up. Twenty-two studies (N = 2638) met inclusion criteria, and 43 comparisons of cognitive behavioral therapy (CBT) were available at follow-up. Active treatments for PTSD yielded large effect sizes from pretest to follow-up and a small controlled effect size compared with non-directive control groups at follow-up. Trauma-focused treatment (TFT) and non-TFT showed large improvements from pretest to follow-up, and effect sizes did not significantly differ from each other. Active treatments for comorbid depressive symptoms revealed small to medium effect sizes at follow-up, and improved PTSD and depressive symptoms remained stable from treatment end to follow-up. Military personnel, low proportion of female patients, and self-rated PTSD measures were associated with decreased effect sizes for PTSD at follow-up. The findings suggest that CBT for PTSD is efficacious in the long term. Future studies are needed to determine the lasting efficacy of other psychological treatments and to confirm benefits beyond 12-month follow-up.

Sign in / Sign up

Export Citation Format

Share Document