scholarly journals Rituximab for the Treatment of Neuromyelitis Optica Spectrum Disorder

2021 ◽  
Vol 1 (2) ◽  
Author(s):  
Srabani Banerjee ◽  
Robyn Butcher

Four systematic reviews, 1 randomized controlled trial (RCT), 1 economic evaluation, and 2 evidence-based guidelines were identified. Four systematic reviews (2 that included moderate- to high-quality evidence and 2 that did not report the quality of the evidence) and 1 RCT (that provided high-quality evidence) reported on the clinical effectiveness of rituximab (RTX) for the treatment of neuromyelitis optica spectrum disorder (NMOSD). Overall, RTX treatment appeared to reduce the relapse rate and disability level compared with pre-treatment or placebo. In terms of reduction in relapse rate and disability, RTX was either better or not different from azathioprine (AZA). For relapse rates, disability levels, and incidence of adverse events, network meta-analyses showed that no treatment was favoured for comparisons between RTX, mycophenolate mofetil (MMF), and cyclophosphamide (CYP). One economic evaluation (of moderate quality) showed that, for patients with NMOSD, in the context of the Thai health care system, RTX biosimilar with CD27+ memory B cell monitoring regimen had the highest probability (48%) of being cost-effective, followed by AZA (30%), MMF (13%), RTX with CD27+ memory B cell monitoring regimen (9%), RTX biosimilar (0%), and RTX (0%) at a willingness-to-pay threshold of 160,000 Thai bhat (equivalent to US$5,289 in 2019 values) per quality-adjusted life-year gained. The 2 guidelines recommended immunosuppressants (RTX, AZA, and MMF) for prevention of NMOSD attacks. In addition, 1 guideline mentioned that tocilizumab, eculizumab, inebilizumab, and satralizumab can be used in NMOSD leave it up to patients who have no response to other immunosuppressants. The quality of the evidence that informed the guidelines and the strength of the recommendations were not reported. Findings need to be interpreted with caution given the limited quantity of evidence on comparative efficacy and safety between various immunosuppressants, that many of the included primary studies were retrospective studies, the heterogeneity among the studies included in the systematic reviews, and the lack of clarity with respect to the strength of the recommendations.

2021 ◽  
Author(s):  
Yaqin Lu ◽  
Yonggui Ge ◽  
Wanqiang Chen ◽  
Wenting Xing ◽  
Lushan Wei ◽  
...  

Abstract Background: An increasing number of systematic reviews (SRs) and meta-analyses (MAs) of clinical trials have begun to investigate the effects of virtual reality (VR) in patients with Parkinson disease (PD). The aim of this overview of was to systematically summarize the current best evidence for the effectiveness of VR therapy for the rehabilitation of people with PD.Methods: We searched SRs/MAs based on randomized controlled trials (RCTs) for relevant literature in PubMed, Embase and Cochrane library databases from inception to December 5, 2020. The methodological quality of included SRs/MAs was evaluated with the Assessing the Methodological Quality of Systematic Reviews 2 (AMSTAR-2), and the evidence quality of outcome measures with the Grading of Recommendations, Assessment, Development and Evaluation (GRADE). Results: A total of nine SRs/MAs were included. The evaluation with AMSTAR-2 showed that all included SRs/MAs but one were rated as low or critically low quality studies. The GRADE criteria revealed 19 studies with very-low-quality evidences, 20 with low-quality evidences, 8 with moderate-quality evidences, and 1 with high-quality evidence. Effectiveness evaluation showed that VR therapy had greater improvement of stride length compared with control groups. However, there were inconsistent results (better or similar effects) regarding to gait speed, gait ability, balance, global motor function, activities of daily living, quality of life, postural control, cognitive function, and neuropsychiatric symptoms.Conclusions: VR therapy appears to be a promising and effective treatment for PD, but there is still a lack of high-quality evidence. In the future, rigorous-designed, high-quality RCTs with larger sample sizes are needed to further verify the effectiveness of VR therapy in the treatment of PD.


2021 ◽  
pp. 1-22
Author(s):  
Sebastian Jugl ◽  
Aimalohi Okpeku ◽  
Brianna Costales ◽  
Earl J. Morris ◽  
Golnoosh Alipour-Haris ◽  
...  

In 2017, a National Academies of Sciences, Engineering, and Medicine (NASEM) report comprehensively evaluated the body of evidence regarding cannabis health effects through the year 2016. The objectives of this study are to identify and map the most recently (2016–2019) published literature across approved conditions for medical cannabis and to evaluate the quality of identified recent systematic reviews, published following the NASEM report. Following the literature search from 5 databases and consultation with experts, 11 conditions were identified for evidence compilation and evaluation: amyotrophic lateral sclerosis, autism, cancer, chronic noncancer pain, Crohn’s disease, epilepsy, glaucoma, human immunodeficiency virus/AIDS, multiple sclerosis (MS), Parkinson’s disease, and posttraumatic stress disorder. A total of 198 studies were included after screening for condition-specific relevance and after imposing the following exclusion criteria: preclinical focus, non-English language, abstracts only, editorials/commentary, case studies/series, and non-U.S. study setting. Data extracted from studies included: study design type, outcome definition, intervention definition, sample size, study setting, and reported effect size. Few completed randomized controlled trials (RCTs) were identified. Studies classified as systematic reviews were graded using the Assessing the Methodological Quality of Systematic Reviews-2 tool to evaluate the quality of evidence. Few high-quality systematic reviews were available for most conditions, with the exceptions of MS (9 of 9 graded moderate/high quality; evidence for 2/9 indicating cannabis improved outcomes; evidence for 7/9 indicating cannabis inconclusive), epilepsy (3 of 4 graded moderate/high quality; 3 indicating cannabis improved outcomes; 1 indicating cannabis inconclusive), and chronic noncancer pain (12 of 13 graded moderate/high quality; evidence for 7/13 indicating cannabis improved outcomes; evidence from 6/7 indicating cannabis inconclusive). Among RCTs, we identified few studies of substantial rigor and quality to contribute to the evidence base. However, there are some conditions for which significant evidence suggests that select dosage forms and routes of administration likely have favorable risk-benefit ratios (i.e., epilepsy and chronic noncancer pain). The body of evidence for medical cannabis requires more rigorous evaluation before consideration as a treatment option for many conditions, and evidence necessary to inform policy and treatment guidelines is currently insufficient for many conditions.


Author(s):  
Michaela Gabes ◽  
Helge Knüttel ◽  
Gesina Kann ◽  
Christina Tischer ◽  
Christian J. Apfelbacher

Abstract Purpose To critically appraise, compare and summarize the quality of all existing PROMs that have been validated in hyperhidrosis to at least some extend by applying the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN) methodology. Thereby, we aim to give a recommendation for the use of PROMs in future clinical trials in hyperhidrosis. Methods We considered studies evaluating, describing or comparing measurement properties of PROMs as eligible. A systematic literature search in three big databases (MEDLINE, EMBASE and Web of Science) was performed. We assessed the methodological quality of each included study using the COSMIN Risk of Bias checklist. Furthermore, we applied predefined quality criteria for good measurement properties and finally, graded the quality of the evidence. Results Twenty-four articles reporting on 13 patient-reported outcome measures were included. Three instruments can be further recommended for use. They showed evidence for sufficient content validity and moderate- to high-quality evidence for sufficient internal consistency. The methodological assessment showed existing evidence gaps for eight other PROMs, which therefore require further validation studies to make an adequate decision on their recommendation. The Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) and the short-form health survey with 36 items (SF-36) were the only questionnaires not recommended for use in patients with hyperhidrosis due to moderate- to high-quality evidence for insufficient measurement properties. Conclusion Three PROMs, the Hyperhidrosis Quality of Life Index (HidroQoL), the Hyperhidrosis Questionnaire (HQ) and the Sweating Cognitions Inventory (SCI), can be recommended for use in future clinical trials in hyperhidrosis. Results obtained with these three instruments can be seen as trustworthy. Nevertheless, further validation of all three PROMs is desirable. Systematic review registration PROSPERO CRD42020170247


2021 ◽  
Vol 42 (Supplement_1) ◽  
Author(s):  
A C Campagnolo Goncalves Toledo ◽  
N Soares De Almeida ◽  
A Pierucci ◽  
A Straioto Salomao ◽  
I Ribeiro Lemes ◽  
...  

Abstract Introduction Smartphone applications for health (M-Health) seem to overcome barriers to access Cardiovascular Rehabilitation Programs (CRP), because of their high degree of acceptance and also their potential to influence the frequency of physical exercise in weight loss. Objective To analyze the effectiveness of the combination of M-Health and CRP compared to CRP alone on functional capacity, adherence to CRP, management of cardiovascular risk factors in cardiac patients. Design Systematic Review and Meta-Analysis. Methods The following databases were used Medline via Ovid, EMBASE, Central, PEDro and SPORTDiscus via EBSCOhost from their inception until July/2020. We included randomized controlled trials investigating the effects of M-Health in combination with CRP compared to CRP alone in adults with heart disease, and the interventions with M-Health consisted of text messages, e-mails, and applications. The primary outcome of this review was functional capacity, measured by VO2peak, or self-reported physical activity (METs.min/week). PEDro scale was used to assess the methodological quality of the studies and the GRADE approach to assess the overall quality of evidence. Pooled estimates were calculated using a random effect model to obtain mean difference (MD) or standardized mean differences (SMD) and their respectives 95% confidence intervals (CI). Results Nineteen RCTs were eligible, the median risk of bias was 7 out of 10 points. The primary endpoint was analyzed by subgroups, time of intervention and kind of type CRP, eigthteen of these studies assessed functional capacity. CRP in combination with a m-health intervention was more effective than CRP alone in improving VO2peak, ml/min/kg, (MD: 0.84, CI: 0.30 to 1.38; I2=0%, high quality evidence, 12 trials, n=1889) at short-term follow-up, but at medium-term follow-up (MD: 0.84, CI: −0.26 to 1.41; I2=0%, high quality evidence, 8 trials, n=927,). Similarly, CRP associated with m-health was superior to CRP alone in increasing self-reported at short-term, METs.min/week, (MD:1.31, CI: −0.24 to 2.37; I2 = not aplicable, very low quality evidence, 1 trial, n=18), and at medium-term follow-up (MD: 0.18, CI: −0.01 to 0.36; I2=56%, moderate quality evidence, 4 trials, n=1107). Conclusion High quality of evidence shows that M-Health improves cardiorespiratory fitness at short-term follow-up. In addition, supervised program showed to be more effective than non-supervised. Funding Acknowledgement Type of funding sources: None.


2021 ◽  
Vol 77 (2) ◽  
Author(s):  
Hans-Rudolf Weiss ◽  
Xiaofeng Nan ◽  
Matthew A. Potts

Background: High-quality evidence exists to support physiotherapy and brace treatment for scoliosis and other spinal deformities. However, according to previous systematic reviews, it seems that no evidence exists for surgery. Nevertheless, the number of research articles focussing on spinal surgery highly exceeds the number of articles focussing on conservative treatment.Objective: The purpose of this study is to conduct an updated search for systematic reviews providing high-quality evidence for spinal surgery in patients with spinal deformities.Method: A narrative review including PubMed and the Cochrane database was conducted on April 12, 2020, with the following search terms: (1) spinal deformities, surgery, systematic review and outcome; (2) kyphosis, surgery, systematic review and outcome; (3) Scheuermann’s disease, surgery, systematic review and outcome, and (4) scoliosis, surgery, systematic review and outcome.Results: No reviews containing prospective controlled or randomised controlled studies were found providing evidence for surgery.Conclusions: A general indication for spine surgery just based on the Cobb angle is not given. In view of the long-term unknown variables and the possible long-term complications of such treatment, a surgical indication for patients with spinal deformities must be reviewed on an individual basis and considered carefully. A current systematic review appears necessary in order to be able to draw final conclusions on the indication for surgery in patients with spinal deformities.Clinical implications: In view of the increasing number of surgeons with an affiliation to industry, the indication for surgery needs to be given by independent conservative specialists for spinal deformities in order to provide an objective recommendation.


Author(s):  
Vasileios Korakakis ◽  
Rod Whiteley ◽  
Argyro Kotsifaki ◽  
Manos Stefanakis ◽  
Yiannis Sotiralis ◽  
...  

Abstract Purpose The evaluation of measurement properties such as reliability, measurement error, construct validity, and responsiveness provides information on the quality of the scale as a whole, rather than on an item level. We aimed to synthesize the measurement properties referring to reliability, measurement error, construct validity, and responsiveness of the Victorian Institute of Sport Assessment questionnaires (Achilles tendon—VISA-A, greater trochanteric pain syndrome—VISA-G, proximal hamstring tendinopathy—VISA-H, patellar tendon—VISA-P). Methods A systematic review was conducted according to Consensus-based Standards for the Selection of Health Measurement Instruments methodology (COSMIN). PubMed, Cochrane, CINAHL, EMBASE, Web of Science, SportsDiscus, grey literature, and reference lists were searched. Studies assessing the measurement properties concerning reliability, validity, and responsiveness of the VISA questionnaires in patients with lower limb tendinopathies were included. Two reviewers assessed the methodological quality of studies assessing reliability, validity, and responsiveness using the COSMIN guidelines and the evidence for these measurement properties. A modified Grading of Recommendations Assessment Development and Evaluation (GRADE) approach was applied to the evidence synthesis. Results There is moderate-quality evidence for sufficient VISA-A, VISA-G, and VISA-P reliability. There is moderate-quality evidence for sufficient VISA-G and VISA-P measurement error, and high-quality evidence for sufficient construct validity for all the VISA questionnaires. Furthermore, high-quality evidence exists with regard to VISA-A for sufficient responsiveness in patients with insertional Achilles tendinopathy following conservative interventions. Conclusions Sufficient reliability, measurement error, construct validity and responsiveness were found for the VISA questionnaires with variable quality of evidence except for VISA-A which displayed insufficient measurement error. Level of evidence IV. Registration details Prospero (CRD42018107671); PROSPERO reference—CRD42019126595.


2018 ◽  
Vol 678 (1) ◽  
pp. 180-191 ◽  
Author(s):  
Adam Gamoran

The evidence movement has attended more to improving the supply of evidence than to increasing demand, so even as rigorous evidence production has increased, the use of evidence remains all too rare. A growing body of research indicates that the quality of relationships between researchers, policy-makers, and intermediaries plays a central role in whether rigorous evidence informs decisions in policy and practice. Creating structures to support such relationships remains a major challenge. Yet even when high-quality evidence is used, the intended benefits may not ensue because of broader challenges in society at large. Consequently, we should temper our expectations for the benefits of evidence-based policymaking, but not give up the effort.


2021 ◽  
Vol 12 ◽  
Author(s):  
Jie Zhang ◽  
Qianying Yu ◽  
Li Peng ◽  
Yuesi Qin ◽  
Mingyi Jing ◽  
...  

Background: In recent years, systematic reviews/meta-analyses (SRs/MAs) of Chinese herbal medicine (CHM) for psoriasis have continuously emerged. Their methods and evidence quality, however, are yet to be evaluated, and whether their conclusions can provide clinicians with reliable evidence is still debatable.Objectives: This overview aims to evaluate the methodological quality, risk of bias, and reporting quality of relevant SRs/MAs, as well as the current evidence of CHM for treating psoriasis.Methods: We searched nine electronic databases from their respective time of establishment to January 20, 2021, as well as the reference lists of the included SRs/MAs, protocol registries, and gray literature. Two reviewers independently used the following: A Measurement Tool to Assess Systematic Reviews (AMSTAR) 2, Risk of Bias in Systematic Reviews (ROBIS), the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA), and Grades of Recommendations, Assessment, Development and Evaluation (GRADE) to evaluate the methodological quality, risk of bias, reporting quality, and evidence quality of the included SRs/MAs.Results: This review included 14 SRs/MAs involving 45 outcomes, of which 12 (85.71%) SRs/MAs had a very low quality evaluated by AMSTAR 2 and 7 (50.00%) SRs/MAs had a high risk of bias assessed by ROBIS. The protocol and registration and funding statements were the major reporting flaws according to the PRISMA checklist. The evaluation with the GRADE system demonstrated no outcome of high-quality evidence, and inconsistent efficacy evaluations were found in this overview. Only 15 (33.33%) outcomes were moderate-quality evidence, supporting the claim that CHM plus Western medicine (WM) was superior to WM. Generally low quality of evidence showed no difference in the incidence of adverse events between the combined therapy and WM. However, the conclusion that CHM was superior to WM cannot be drawn due to the inconsistent results.Conclusion: Despite that CHM has the potential benefit and safety in the adjuvant treatment of psoriasis, the conclusion should be treated with caution because of the generally low quality of methodology and evidence. In the future, high-quality randomized controlled trials (RCTs) should be carried out, and the quality of relevant SRs should also be improved to promote their clinical application.


2021 ◽  
Author(s):  
Guixing Xu ◽  
Qiwei Xiao ◽  
Biqing Huang ◽  
Hanzhou Lei ◽  
Zihan Yin ◽  
...  

Abstract Background: The effects of acupuncture for major depressive disorder (MDD) uncertain. This review aims to determine the effects of Acupuncture for MDD .Methods: Eight Database were searched to identify randomized control trials (RCTs) on Acupuncture for MDD. All RCTs with adult participants undergoing acupuncture treatment for MDD were included. The primary outcome measure was the 24-item Hamilton rating scale for depression (HAMD-24). We used random-effects meta-analysis to synthesis the results with mean difference or odds ratio. Furthermore, the potential heterogeneity was tested through meta-regression/subgroup analyses/sensitive analysis. The quality of evidence for each outcome was assessed by the Grading of Recommendations Assessment, Development and Evaluation approach.Results: Forty-three studies were included: 9 acupuncture versus sham-acupuncture (n=920), 26 acupuncture versus antidepressants (n=2169), 9 acupuncture plus antidepressants versus antidepressants (n=667). Of the 43 high-quality articles, 24 and 8 were determined to have a low and moderate risk of bias, respectively. The pooled results for HAMD-24 and SDS revealed the clinical benefits of Acupuncture or Acupuncture plus antidepressants compared to sham-acupuncture or antidepressants, with high quality evidence. Furthermore, high quality of evidence showed that acupuncture led to fewer adverse effects compared to antidepressants.Conclusions: Acupuncture or acupuncture plus antidepressants were significantly associated with reduced HAMD-24 scores, with high-quality evidence. More rigorous trials are needed to identify the optimal frequency of Acupuncture for MDD and integrate such evidence into clinical care to reduce antidepressant use.


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