scholarly journals FRI0460 SAFETY OF BIOLOGICAL AGENTS IN JUVENILE IDIOPATHIC ARTHRITIS: A META-ANALYSIS OF OBSERVATIONAL STUDIES

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 827.2-827
Author(s):  
N. Cabrera ◽  
G. Avila ◽  
A. Belot ◽  
J. P. Larbre ◽  
G. Cattivelli ◽  
...  
Keyword(s):  
Juvenile Idiopathic Arthritis ◽  
Clinical Practice ◽  
Incidence Rate ◽  
Observational Studies ◽  
Meta Analysis ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Serious Infections ◽  
Randomised Controlled

Background:Follow-up cohorts (observational studies) were initiated consecutively or simultaneously to the development of randomised controlled trials (RCTs) in JIA patients(1,2). They help to identify many complications observed only in clinical practice related to off label use, coadministration of treatments, drug misuse, and occurrence of rare or unexpected event. In addition, observational studies include a higher number of patients with a longer duration of follow-up compared to randomised trials. Hence, they have a higher power to capture the occurrence of serious adverse events (SAE) in daily clinical practice3.Objectives:To estimate the incidence of serious adverse events (SAEs) including serious infections, malignancies, and death in patients with juvenile idiopathic arthritis (JIA) treated with biological agents (BAs) in daily clinical practice, using meta-analysis techniques.Methods:We systematically searched, up to May 2019, Medline and Embase databases for observational studies performed in JIA disease under BAs treatment. Outcomes were SAEs, serious infections, malignancies and all-cause mortality. Complementary, the incidence of SAEs in randomised controlled trials (RCTs) with withdrawal and parallel designs was performed by meta-analysis.Results:A total of 31 observational studies were included (6811 patients totalizing 17530 patients-years [PY] of follow-up). The incidence rate of SAEs was similar in observational cohorts and withdrawal RCTs (4.46 events per 100 PY, 95% CI 2.85- 6.38, I2= 95%) and 3.71 events per 100 PY (95%CI 0.0-13.34), I2= 56%, respectively). The incidence of SAE was lower in parallel RCT. The incidence rate of serious infections, malignancies and death in observational cohorts was estimated at 0.74 events per 100 PY (95%CI 0.32-1.30, I2=83%), 0.10 events per 100 PY (95% CI 0.06-0.16, I2=0%) and 0.09 events per 100 PY (95% CI 0.05-0.14, I2=0%), respectively. Infections were the known cause of death in 8 of the 14 deaths. In meta-regression and subgroup analysis, variation of serious infections rates were partially explained by follow-up time (R2= 30.3%, p= 0.0008), JIA categories (all JIA versus polyarticular versus systemic JIA categories, p= 0.001) and cohort quality (Newcastle-Ottawa score ≥ to 6 versus ≤ to 5 stars, p= 0.0025).Conclusion:Our results suggest that the incidence rate of SAEs related to BAs in JIA disease is similar to those observed in randomised withdrawal trials. The overall incidence remained low. However, unsatisfactory description of SAEs prevents analysis of hospitalisation causes. Infection and, to a lesser extent, cancer and death, explain only part of burden of BAs.References:[1]Berard RA, Laxer RM. Learning the hard way: clinical trials in juvenile idiopathic arthritis. Ann Rheum Dis. 2018;77(1):1–2.[2]Swart J, Giancane G, Horneff G, Magnusson B, Hofer M, Alexeeva Е, et al. Pharmacovigilance in juvenile idiopathic arthritis patients treated with biologic or synthetic drugs: combined data of more than 15,000 patients from Pharmachild and national registries. Arthritis Res Ther. 2018 27;20(1):285.[3]Monti S, Grosso V, Todoerti M, Caporali R. Randomized controlled trials and real-world data: differences and similarities to untangle literature data. Rheumatol Oxf Engl. 2018 01;57(57 Suppl 7):vii54–Disclosure of Interests:None declared

scholarly journals The impact of a run-in period on treatment effects in cardiovascular prevention randomised control trials: A protocol for a comprehensive review and meta-analysis

2020 ◽  
Vol 3 ◽  
pp. 82
Author(s):  
Robert Murphy ◽  
Emer McGrath ◽  
Aoife Nolan ◽  
Andrew Smyth ◽  
Michelle Canavan ◽  
...  
Keyword(s):  
Randomised Controlled Trials ◽  
Treatment Effects ◽  
Meta Analysis ◽  
Cardiovascular Prevention ◽  
Controlled Trials ◽  
Loss To Follow Up ◽  
Relative Risks ◽  
Prevention Trials ◽  
Randomised Controlled

Background: A run-in period is often employed in randomised controlled trials to increase adherence to the intervention and reduce participant loss to follow-up in the trial population. However, it is uncertain whether use of a run-in period affects the magnitude of treatment effect. Methods: We will conduct a sensitive search for systematic reviews of cardiovascular preventative trials and a complete meta-analysis of treatment effects comparing cardiovascular prevention trials using a run-in period (“run-in trials”) with matched cardiovascular prevention trials that did not use a run-in period (“non-run-in trials”). We describe a comprehensive matching process which will match run-in trials with non-run-in trials by patient populations, interventions, and outcomes. For each pair of run-in trial and matched non-run-in trial(s), we will estimate the ratio of relative risks and 95% confidence interval. We will evaluate differences in treatment effect between run-in and non-run-in trials and our and our priamry outcome will be the ratio of relative risks for matched run-in and non-run-in trials for their reported cardiovascular composite outcome. Our secondary outcomes are comparisons of mortality, loss to follow up, frequency of adverse events and methodological quality of trials. Conclusions: This study will answer a key question about what influence a run-in period has on the magnitude of treatment effects in randomised controlled trials for cardiovascular prevention therapies.

Effect of action observation therapy on motor function in children with cerebral palsy: a systematic review of randomized controlled trials with meta-analysis

2020 ◽  
pp. 026921552095434
Author(s):  
Naglaa Abdelhaleem ◽  
Samar Taher ◽  
Menna Mahmoud ◽  
Ahmad Hendawy ◽  
Maged Hamed ◽  
...  
Keyword(s):  
Cerebral Palsy ◽  
Methodological Quality ◽  
Randomised Controlled Trials ◽  
Action Observation ◽  
Meta Analysis ◽  
Post Treatment ◽  
Controlled Trials ◽  
Children With Cerebral Palsy ◽  
Randomised Controlled

Objective: To evaluate the evidence of using Action Observation Therapy in the rehabilitation of children with Cerebral Palsy. Study design: Systematic review with meta-analysis of Randomised Controlled Trials. Methods: For the purpose of identifying relevant studies, six databases were searched from inception until July 2020. The methodological quality was assessed by Physiotherapy Evidence Database scale. The outcomes were classified within the framework of the International Classification of Functioning. A pooled meta-analysis was performed on studies that demonstrated homogeneity. Results: Twelve randomised controlled trials with 307 participants were included with six of them were included in the meta-analysis. Non-significant difference between the groups was demonstrated by meta-analysis. Results of capacity assessed in post treatment and follow up evaluation were (0.06, –0.22 to 0.34, 95% (CI); P = 0.69 and (–0.35, –0.96 to 0.27, 95% (CI); P = 0.27); respectively. Actual performance in post-treatment and follow up were (0.10, –0.22 to 0.48, 95% (CI); P = 0.62) and (0.01, –0.40 to 0.41, 95% (CI); P = 0.97); respectively. Perceived performance evaluated using (ABILHAND-KIDS) were (0.30, –0.28 to 0.89, 95% (CI); P = 0.31) and (0.15, –0.43 to 0.73, 95% (CI); P = 0.61) for post treatment and follow up; respectively. Overall effect on activity domain was (0.08, –0.11 to 0.28, 95% (CI); P = 0.86) immediately and (0.04, –0.33 to 0.26, 95% (CI); P = 0.49) at follow-up; respectively. Conclusion: No evidence of benefit had been found to draw a firm conclusion regarding the effectiveness of action observation therapy in the rehabilitation of children with cerebral palsy due to limitations in methodological quality and variations between studies.

scholarly journals Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis

2019 ◽  
Vol 54 (18) ◽  
pp. 1073-1080 ◽  
Author(s):  
Andre Niemeijer ◽  
Hans Lund ◽  
Signe Nilssen Stafne ◽  
Thomas Ipsen ◽  
Cathrine Luhaäär Goldschmidt ◽  
...  
Keyword(s):  
Systematic Review ◽  
Relative Risk ◽  
Adverse Events ◽  
Exercise Therapy ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Control Group ◽  
Controlled Trials ◽  
Serious Adverse Events ◽  
Randomised Controlled

ObjectiveTo evaluate the relative risk (RR) of serious and non-serious adverse events in patients treated with exercise therapy compared with those in a non-exercising control group.DesignSystematic review and meta-analysis.Data sourcesPrimary studies were identified based on The Cochrane Database of Systematic Reviews investigating the effect of exercise therapy.Eligibility criteriaAt least two of the authors independently evaluated all identified reviews and primary studies. Randomised controlled trials were included if they compared any exercise therapy intervention with a non-exercising control. Two authors independently extracted data. The RR of serious and non-serious adverse events was estimated separately.Results180 Cochrane reviews were included and from these, 773 primary studies were identified. Of these, 378 studies (n=38 368 participants) reported serious adverse events and 375 studies (n=38 517 participants) reported non-serious adverse events. We found no increase in risk of serious adverse events (RR=0.96 (95%CI 0.90 to 1.02, I2: 0.0%) due to exercise therapy. There was, however, an increase in non-serious adverse events (RR=1.19 (95%CI 1.09 to 1.30, I2: 0.0%). The number needed to treat for an additional harmful outcome for non-serious adverse events was 6 [95%CI 4 to 11).ConclusionParticipating in an exercise intervention increased the relative risk of non-serious adverse events, but not of serious adverse events. Exercise therapy may therefore be recommended as a relatively safe intervention.PROSPERO registration numberCRD42014014819.

scholarly journals New Evidence in the Booming Field of Online Mindfulness: An Updated Meta-Analysis of Randomised Controlled Trials (Preprint)

2021 ◽  
Author(s):  
Marion Sommers-Spijkerman ◽  
Judith Austin ◽  
Ernst Bohlmeijer ◽  
Wendy Pots
Keyword(s):  
Mental Health ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Well Being ◽  
Evidence Base ◽  
Effect Sizes ◽  
Controlled Trials ◽  
Long Term Follow Up ◽  
Randomised Controlled

BACKGROUND There is a need for regularly updating the evidence base on the effectiveness of online mindfulness-based interventions (MBIs), especially considering how fast this field is growing and developing. OBJECTIVE The current study presents an updated meta-analysis of randomised controlled trials assessing the effects of online MBIs on mental health, as well as the potential moderators of those effects. METHODS A systematic literature search was conducted in PsycINFO, PubMed and Web of Science up to July 19th, 2019. Seventy trials totalling 91 comparisons were included. Pre-to-post and pre-to-follow-up between-group effect sizes (Hedges’ g) were calculated for depression, anxiety, stress, well-being and mindfulness, using a random effects model. RESULTS The findings revealed statistically significant moderate pre-to-post effects on stress (g=0.41) and mindfulness (g=0.43) and small effects on depression (g=0.31) and anxiety (g=0.23). For well-being, a significant effect was found only when omitting low quality studies (g=0.34). Significant but small follow-up effects were found for depression (g=0.25), anxiety (g=0.17) and stress (g=-0.11). Subgroup analyses revealed that online MBIs resulted in higher effect sizes for stress when offered with guidance. For stress and mindfulness, studies that used an inactive control condition yielded larger effects. CONCLUSIONS Our findings do not only demonstrate that the field of online MBIs is booming, but also corroborate previous evidence that online MBIs are beneficial for improving mental health outcomes in a broad range of samples. To advance the field of online MBIs, future trials should pay specific attention to methodological quality, adherence and long-term follow-up measurements.

scholarly journals 470 Could Covid-19 Change the Way We Do Clinics for The Better? A Comparison of Remote Versus Outpatient Clinic Follow-Up for Surgical Patients: A Meta-Analysis of Randomised Controlled Trials

2021 ◽  
Vol 108 (Supplement_2) ◽  
Author(s):  
Emily Oates ◽  
Grace Hui Chin Lim ◽  
Edward J Nevins ◽  
Venkatesh Kanakala
Keyword(s):  
Outpatient Clinic ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Surgical Patients ◽  
Surgical Patient ◽  
Controlled Trials ◽  
Randomised Controlled ◽  
The Uk ◽  
The Way

Abstract Introduction As the Covid-19 pandemic hit the UK, the way the NHS operates changed overnight. One change was the move to remote appointments (RA) by video or telephone. This meta-analysis (MA) of randomised controlled trials (RCTs) looks at existing evidence on RA and aims to discover if surgical patients are satisfied with them. Method A literature search of RCTs of surgical patient satisfaction of RA versus conventional outpatient clinic (OPC) was performed. The PubMed, EMBASE and Google Scholar databases were searched to include articles from January 2000 to 2020. A random effects MA model was used to compare outcomes. Results All 5 RCTs showed that patients were as satisfied with RA as OPC (RR = 1.00, [0.97-1.03] p = 0.96). Furthermore, both patient cohorts would prefer RA for future follow-up (RR = 2.28 [1.85-2.82] p < 0.00001). 1 RCT performed a cost analysis and found the cost to institutions was less in the RA group ($19.05 vs $52.76). All other RCTs suggested cost to patients and institutions would be less for RA. Conclusions Surgical patients are satisfied with RA and in fact would prefer them, thus indicating that out with the Covid-19 pandemic RAs could be continued, and in doing so may well save money for patients and the NHS.

scholarly journals Evidence into practice

2002 ◽  
Vol 181 (2) ◽  
pp. 99-101 ◽  
Author(s):  
Rupatharshini Chilvers ◽  
Glynn Harrison ◽  
Attila Sipos ◽  
Madeline Barley
Keyword(s):  
Clinical Practice ◽  
Social Workers ◽  
Randomised Controlled Trials ◽  
Meta Analysis ◽  
Routine Clinical Practice ◽  
Controlled Trials ◽  
External Evidence ◽  
Randomised Controlled ◽  
Health Field

Psychiatrists have long recognised that routine clinical practice needs to be shaped and informed by external evidence (Lewis, 1958). Psychiatric researchers were among the first to utilise multi-centre randomised controlled trials (demonstrating the effectiveness of antipsychotics), and psychologists were among the first in the health field to develop techniques of meta-analysis. Social workers, too, point to their tradition with the publication of one of the earliest controlled trials (Lehrman, 1949).

scholarly journals Evidence of efficacy of acupuncture in the management of low back pain: a systematic review and meta-analysis of randomised placebo- or sham-controlled trials

2019 ◽  
Vol 38 (1) ◽  
pp. 15-24
Author(s):  
Yan Xiang ◽  
Jin-yuan He ◽  
Huan-huan Tian ◽  
Bing-yan Cao ◽  
Rui Li
Keyword(s):  
Low Back Pain ◽  
Back Pain ◽  
Weighted Mean Difference ◽  
Meta Analysis ◽  
Pain Reduction ◽  
Mean Difference ◽  
Controlled Trials ◽  
Low Back ◽  
Randomised Controlled

Objectives: To assess the evidence for the efficacy of acupuncture for non-specific low back pain (NSLBP), compared with sham or placebo therapies. Methods: We searched Cochrane CENTRAL to December 2016, and conducted searches from 1980 to December 2016 in PubMed, MEDLINE and Embase. There were no regional restrictions applied. We included only randomised controlled trials of adults with NSLBP. Placebo/sham procedures were required of the control interventions. The trials were combined using meta-analysis when the data reported allowed for statistical pooling. Results: 14 trials (2110 participants) were included in the review, and 9 were included in the meta-analysis. Immediately after the acupuncture treatment we found statistically significant differences in pain reduction between acupuncture and sham or placebo therapy (standardised mean difference (SMD) −0.40, 95% CI −0.54 to −0.25; I2 7%; 753 participants; 9 studies), but there were no differences in function (weighted mean difference (WMD) −1.05, 95% CI −3.61 to 1.52; I2 79%; 462 participants; 4 studies). At follow-up, there were significant differences in pain reduction (SMD −0.46, 95% CI −0.82 to −0.09; I2 67%), but not in function (WMD −0.98, 95%CI −3.36 to 1.40; I2 87%). We conducted subgroup analyses both immediately after treatment and at follow-up. Conclusion: There is moderate evidence of efficacy for acupuncture in terms of pain reduction immediately after treatment for NSLBP ((sub)acute and chronic) when compared to sham or placebo acupuncture. Registration: PROSPERO registration no. CRD42017059438.

scholarly journals Efficacy and safety of biologics in the treatment of moderate to severe psoriasis: a comprehensive meta-analysis of randomized controlled trials

2013 ◽  
Vol 29 (suppl 1) ◽  
pp. s17-s31 ◽  
Author(s):  
Cassyano Januário Correr ◽  
Inajara Rotta ◽  
Thaís de Souza Teles ◽  
Rangel Ray Godoy ◽  
Bruno Salgado Riveros ◽  
...  
Keyword(s):  
Adverse Events ◽  
Meta Analysis ◽  
Biological Agents ◽  
Severe Psoriasis ◽  
Biological Agent ◽  
Controlled Trials ◽  
Efficacy And Safety ◽  
Short Term ◽  
Serious Adverse Events

We conducted a systematic review and metaanalysis of randomized placebo-controlled trials in moderate-to-severe psoriasis treated with biological agents, with a follow-up of 10-14 weeks. Overall, 41 studies, with mean Jadad score of 4.4, and 15,586 patients were included. For the efficacy outcomes PASI 50, 75 and 90 our findings are not conclusive to point what biological agent has the greatest response in short term follow-up. There were no statistical differences between placebo and biologics for the occurrence of infections and serious adverse events. Ustekinumab 45mg showed lower withdrawal due to adverse events compared with the placebo. Based on data available up to now, it is not possible to determine which biological agent is the best for PASI 50, 75 or 90 after 10-14 weeks of treatment. At the same follow-up, overall safety seems to be the same for all biological agents and Ustekinumab 45mg the most well tolerated drug. To better understand efficacy and safety, indirect meta-analysis comparing drug-to-drug is required since randomized placebo-controlled trials may not be feasible.

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