Quality of control groups in randomised trials of multiple myeloma enrolling in the USA: a systematic review

2021 ◽  
Vol 8 (4) ◽  
pp. e299-e304
Author(s):  
Ghulam Rehman Mohyuddin ◽  
Kelly Koehn ◽  
Douglas Sborov ◽  
Brian McClune ◽  
Al-Ola Abdallah ◽  
...  
Keyword(s):  
Systematic Review ◽  
Multiple Myeloma ◽  
Randomised Trials ◽  
Control Groups ◽  
Quality Of Control ◽  
The Usa

scholarly journals The Standard of Care Definitions on COVID-19 Pharmacological Clinical Trials: A Systematic Review

2021 ◽  
Vol 12 ◽  
Author(s):  
Antonio Addis ◽  
Laura Amato ◽  
Fabio Cruciani ◽  
Rosella Saulle ◽  
Franco De Crescenzo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Standard Of Care ◽  
Pharmacological Intervention ◽  
Pharmacological Interventions ◽  
Control Groups ◽  
Quality Of Control ◽  
Active Controls

Background: Standard of Care (SoC) has been used with different significance across Randomized Clinical Trials (RCTs) on the treatment of Covid-19. In the context of a living systematic review on pharmacological interventions for COVID-19, we assessed the characteristics of the SoC adopted in the published RCTs.Methods: We performed a systematic review searching Medline, Pubmed, Embase, Cochrane Covid-19 register, international trial registers, medRxiv, bioRxiv, and arXiv up to April 10, 2021. We included all RCTs comparing any pharmacological intervention for Covid-19 against any drugs, placebo, or SoC. All trials selected have been classified as studies with SoC including treatments under investigation for COVID-19 (SoC+); studies with SoC without specifications regarding the potential therapies allowed (SoC-); studies including as control groups Placebo (P) or active controls (A+).Results: We included in our analysis 144 RCTs, comprising 78,319 patients. Most of these trials included SoC (108; 75.0%); some in all arms of the study (69.7%) or just as independent comparators (30.3%). Treatments under investigation for COVID-19 in other trials were included in the SoC (SoC+) in 67 cases (62.0%), Thirty-one different therapeutic agents (alone or in combination) were counted within the studies with SoC+: mostly hydroxychloroquine or chloroquine (28), lopinavir/ritonavir (20) or azithromycin (16). No specification was given regarding treatment allowed in the control groups (SoC-) in 41 studies (38.0%).Conclusion: Our analysis shows that the findings emerging from several clinical trials regarding the efficacy and safety of pharmacological intervention for COVID-19 might be jeopardized by the quality of control arms.

scholarly journals How the Pilates Method Can Influence Sports Performance in Different Modalities

2020 ◽  
Vol 25 (264) ◽  
pp. 139-152
Author(s):  
Manoela Abreu ◽  
Franciele Carvalho Santos ◽  
Ana Laura Nogueira ◽  
Matheus Lima Zampieri ◽  
Dernival Bertoncello
Keyword(s):  
Systematic Review ◽  
Methodological Quality ◽  
Web Of Science ◽  
Sports Performance ◽  
Review Of The Literature ◽  
Control Groups ◽  
Future Studies ◽  
Pilates Method

The aim of this study was to perform a systematic review of the literature in order to investigate the effects of the Pilates Method on athletes of different sports. Methods: Researches were carried out in databases (SciELO, LILACS, PubMed, Web of Science and SCOPUS) and to evaluate the methodological quality of the studies, the PEDro scale was used. Results: Of the 87 studies found, only four were included. Meta-analyzes to assess flexibility using the Wells Bank's Sit and Reach test and a fleximeter indicated improvement after Pilates application, although there were no statistically significant differences compared to the control groups (Wells Bank's Sit and Reach test: 2 , 83 95% CI: -0.73 to 6.38, I² = 99%; Fleximeter: -0.78, 95% CI: -1.84 to 0.27, I² = 0%). Conclusion: There is evidence of benefits after Pilates intervention. Future studies with standardized protocols, according to the chosen sport, are necessary to determine how the Pilates Method can improve athletes' performance.

scholarly journals A Systematic Review of Neuropsychological Tests for the Assessment of Dementia in Non-Western, Low-Educated or Illiterate Populations

2019 ◽  
Vol 26 (3) ◽  
pp. 331-351 ◽  
Author(s):  
Sanne Franzen ◽  
Esther van den Berg ◽  
Miriam Goudsmit ◽  
Caroline K. Jurgens ◽  
Lotte van de Wiel ◽  
...  
Keyword(s):  
Systematic Review ◽  
Executive Functioning ◽  
Neuropsychological Tests ◽  
Cognitive Domains ◽  
Domain Specific ◽  
Adaptation Procedure ◽  
The Usa ◽  
Low Educated ◽  
Culture Education

AbstractObjective:Neuropsychological tests are important instruments to determine a cognitive profile, giving insight into the etiology of dementia; however, these tests cannot readily be used in culturally diverse, low-educated populations, due to their dependence upon (Western) culture, education, and literacy. In this review we aim to give an overview of studies investigating domain-specific cognitive tests used to assess dementia in non-Western, low-educated populations. The second aim was to examine the quality of these studies and of the adaptations for culturally, linguistically, and educationally diverse populations.Method:A systematic review was performed using six databases, without restrictions on the year or language of publication.Results:Forty-four studies were included, stemming mainly from Brazil, Hong Kong, Korea, and considering Hispanics/Latinos residing in the USA. Most studies focused on Alzheimer’s disease (n = 17) or unspecified dementia (n = 16). Memory (n = 18) was studied most often, using 14 different tests. The traditional Western tests in the domains of attention (n = 8) and construction (n = 15), were unsuitable for low-educated patients. There was little variety in instruments measuring executive functioning (two tests, n = 13), and language (n = 12, of which 10 were naming tests). Many studies did not report a thorough adaptation procedure (n = 39) or blinding procedures (n = 29).Conclusions:Various formats of memory tests seem suitable for low-educated, non-Western populations. Promising tasks in other cognitive domains are the Stick Design Test, Five Digit Test, and verbal fluency test. Further research is needed regarding cross-cultural instruments measuring executive functioning and language in low-educated people.

scholarly journals Effectiveness of Acupuncturing at the Sphenopalatine Ganglion Acupoint Alone for Treatment of Allergic Rhinitis: A Systematic Review and Meta-Analysis

2019 ◽  
Vol 2019 ◽  
pp. 1-10 ◽  
Author(s):  
Qinwei Fu ◽  
Lanzhi Zhang ◽  
Yang Liu ◽  
Xinrong Li ◽  
Yepeng Yang ◽  
...  
Keyword(s):  
Systematic Review ◽  
Allergic Rhinitis ◽  
Total Effective Rate ◽  
Meta Analysis ◽  
Effective Rate ◽  
Disease Classification ◽  
Sphenopalatine Ganglion ◽  
Control Groups ◽  
Vas Score

Aim(s). To evaluate the efficiency of acupuncturing at the sphenopalatine ganglion acupoint alone for treatment of allergic rhinitis. Design. A total of ten online databases were searched to find studies published up to Jan. 2018. Primary outcome measures include the TNSS, the RQLQ score, the VAS score, total effective rate, score for signs and symptoms, and the improvement of disease classification. Study quality of each included article was evaluated by the Cochrane Collaboration risk of bias tool. A meta-analysis was conducted based on the Cochrane systematic review method by using RevMan 5.3 software. Interventions. Acupuncturing SGA alone was the only therapy in experimental group. Interventions in control groups includes sham acupuncture, acupuncturing other regular acupoints, and western medicine. Specific techniques included manual acupuncture and electroacupuncture only. Primary Outcomes. They include TNSS, RQLQ, VAS score, total effective rate, the improvement of disease classification. Results. Ten studies of eight articles involving 1004 participants were included. Result of meta-analysis showed that acupuncturing sphenopalatine ganglion acupoints alone was more effective than control groups. However, several adverse effects were reported. Conclusion. These findings show that acupuncturing the sphenopalatine ganglion acupoint alone has a potential role in alleviating nasal symptoms, improving quality of life for patients, and the effectiveness of acupuncture in the treatment of allergic rhinitis, suggesting it as a considerable therapy for allergic rhinitis. However, more studies are needed to execute a subgroup analysis of various variables and to evaluate the publication bias of the study.

Quality of life of treatment for relapsed/refractory multiple myeloma: a systematic review

2019 ◽  
Vol 19 (10) ◽  
pp. e278
Author(s):  
Maria Nassim ◽  
Jonas Nilsson ◽  
Stojan Zavisic ◽  
Mia Malmenäs ◽  
Iain Fotheringham ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Multiple Myeloma ◽  
Refractory Multiple Myeloma

scholarly journals ​Bereavement support effectiveness for parents of infants and children: a systematic review

2019 ◽  
pp. bmjspcare-2019-001823 ◽  
Author(s):  
Tom Ainscough ◽  
Lorna Fraser ◽  
Joanna Taylor ◽  
Bryony Beresford ◽  
Alison Booth
Keyword(s):  
Systematic Review ◽  
Medical Condition ◽  
Bereavement Support ◽  
Neonatal Deaths ◽  
Significant Difference ◽  
The Usa ◽  
Study Methodology ◽  
Randomised Controlled ◽  
And Control

ObjectivesThis systematic review aims to assess the effectiveness of bereavement support interventions (BSIs) for parents of an infant or a child who has died from a medical condition or in unforeseen circumstances.MethodsA systematic search of MEDLINE, PsycINFO, Embase and CINAHL (1980 to January 2018) was performed to identify studies investigating BSIs for the parents of children who died between the ages of 24 weeks gestation and 30 years. Due to significant clinical and methodological heterogeneity between studies, a narrative synthesis was performed.ResultsThe database searches returned 24 550 records, with a further 6 identified through other sources. Of these, eight studies, reported in nine papers, met the inclusion criteria. Most studies were conducted in the USA (n=5) and in perinatal/neonatal deaths (n=6). Five of the included studies were randomised controlled trials and three were non-randomised comparative studies. Interventions were delivered to groups, individuals or families. Outcomes of interest were grief, mental health, physical health and ‘others’. There were major concerns over the quality of study methods and reporting. Only three of the nine studies reported a significant difference between experimental and control arm participants in any outcomes, despite a total of 23 outcomes being measured.ConclusionsPoor methodology and reporting of the few studies which have assessed BSIs for parents limit any conclusions on their effectiveness. Agreement on core outcomes and more robust study methodology are required in this neglected area of research.

Systematic Review and Meta-Analysis of Randomized Controlled Trials of Erythropoietin in Multiple Myeloma.

Blood ◽  
2004 ◽  
Vol 104 (11) ◽  
pp. 232-232
Author(s):  
Heloisa P. Soares ◽  
Ambuj Kumar ◽  
Franco Silvestris ◽  
Benjamin Djulbegovic
Keyword(s):  
Systematic Review ◽  
Multiple Myeloma ◽  
Randomized Controlled Trials ◽  
Meta Analysis ◽  
Current Evidence ◽  
Controlled Trials ◽  
Randomized Controlled ◽  
Epoetin Alpha

Abstract Background: The current approach for treating anemia in multiple myeloma (MM) patients entails prescribing recombinant erythropoetin (EPO) only if chemotherapy fails initially to raise hemoglobin (Hb) levels. However, this practice is not based on synthesis of the totality of evidence obtained from data of all trials testing EPO exclusively in myeloma patients. Objective: To conduct a systematic review/ meta-analysis (SR/MA) regarding the use of EPO in MM patients. Methods: We conducted a SR of all randomized controlled trials (RCTs) that studied the effect of EPO exclusively in MM patients. We searched all major electronic databases (MEDLINE, LILACS, EMBASE and the Cochrane Controlled Trials Register) as well as performing hand searches of relevant meeting proceedings (ASH, ASCO, EHA), and ongoing NCI trials. We included RCTs that had at least 10 patients in each arm and had compared the use of EPO against a control group. We also identified trials that compared different doses of EPO. We excluded trials that enrolled patients treated with high-dose myeloablative chemotherapy followed by stem cell transplantation or hemodialysis. Results: We identified more than 500 relevant studies; 6 trials met our eligibility criteria and were included in the analysis. Five trials (4 published as full text manuscripts and 1 as the abstract) compared epoetin alpha against a control [placebo (2 trials) or no therapy with or without specification of red cells transfusion trigger level (3 trials)] in anemic MM patients. One trial compared 2 different schedules of epoetin alpha. No trial tested the effect of darbopoeitin. All 5 trials that studied EPO against controls used initial doses of 150 IU 3x/week SC with the possibility of increasing to 300 IU if necessary. In the majority of trials the patients had been receiving chemotherapy at the time EPO was administered. The number of patients included in each trial ranged from 24 to 145. All trials concluded that EPO was superior to a placebo or no treatment in terms of Hb increase. Two trials also concluded that EPO improves quality of life. Our meta-analysis showed that hematological response was favored in the group receiving EPO [relative risk (RR) 7.75; 95% CI 4.19 to 14.35, 4 trials, n = 272]. Mean Hb level improvement with EPO was also significant [weighted mean difference (WMD) 2.29; 95% CI2.00 to -2.58, 3 trials, n = 235]. In terms of adverse events, hypertension was more often found in the EPO arm [RR 5.80; 95% CI 1.30-25.90, 4 trials, n = 290]. Survival and data related to tumor response were not available in all trials. Critical appraisal indicated that available evidence was modest in quantity (5 trials, n= 385 total patients enrolled) and poorly reported in all important methodological domains. Conclusion: Available body of evidence suggests that EPO improves hematological outcomes in patients with myeloma. However, the quality of current evidence is insufficient, data on most important patients’ outcomes are lacking (e.g. survival etc.), thus preventing us from making definitive recommendations regarding the role of EPO in managing anemia in the myeloma setting. A definitive RCT to resolve the role of EPO in myeloma is indicated.

scholarly journals Impact of physical exercise on quality of life of older adults with depression or Alzheimer's disease: a systematic review

2014 ◽  
Vol 36 (3) ◽  
pp. 134-139 ◽  
Author(s):  
Bianca Boscarino Tavares ◽  
Helena Moraes ◽  
Andrea Camaz Deslandes ◽  
Jerson Laks
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Alzheimer’S Disease ◽  
Alzheimer's Disease ◽  
Physical Exercise ◽  
The Elderly ◽  
Pharmacological Intervention ◽  
Older Individuals ◽  
Control Groups

INTRODUCTION: Physical exercise has been associated with improvement of quality of live (QoL), but its effect among the elderly with depression and Alzheimer's disease (AD) is still unclear. This systematic review evaluated randomized and controlled studies about the effect of physical exercise on QoL of older individuals with a clinical diagnosis of depression and AD.METHODS:We searched PubMed, ISI, SciELO and Scopus from December 2011 to June 2013 using the following keywords: physical exercise, quality of life, elderly, depression, Alzheimer's disease. Only six studies met inclusion criteria: two examined patients with AD and four, patients with depression.RESULTS: The studies used different methods to prescribe exercise and evaluate QoL, but all had high quality methods. Findings of most studies with individuals with depression suggested that exercise training improved QoL, but studies with patients with AD had divergent results.CONCLUSIONS: Although different methods were used, results suggested that physical exercise is an effective non-pharmacological intervention to improve the QoL of elderly individuals with depression and AD. Future studies should investigate the effect of other factors, such as the use of specific scales for the elderly, controlled exercise prescriptions and type of control groups.

scholarly journals Berberine for diarrhea in children and adults: a systematic review and meta-analysis

2020 ◽  
Vol 13 ◽  
pp. 175628482096129
Author(s):  
Mingkun Yu ◽  
Xuejing Jin ◽  
Changhao Liang ◽  
Fanlong Bu ◽  
Deng Pan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Randomized Controlled Trials ◽  
Clinical Cure ◽  
Clinical Cure Rate ◽  
Controlled Trials ◽  
Cure Rate ◽  
Control Groups ◽  
Quality Of Evidence ◽  
Randomized Controlled

Background: Diarrhea is a ubiquitous digestive system disease, leading to loss of fluid and electrolytes, and may be life-threatening, especially in children and adults who are immunosuppressed or malnourished. Berberine has a broad-spectrum antibiotic activity and is very widely used to treat diarrhea in China. No systematic review has been carried out to evaluate the evidence presented in clinical trials. The aim of this study was to assess the effectiveness and safety of berberine in diarrhea treatment among children and adults. Methods: Seven databases and two clinical trial registries were searched on 1 September 2019. Randomized controlled trials were included, where participants were diagnosed (first diagnosed) as having diarrhea according to clear diagnostic criteria. Berberine alone or in combination with Western medication as intervention were included. Subgroup analyses were conducted based on children or adults, acute or persistent diarrhea, infectious or noninfectious and treatment courses. Primary outcomes were clinical cure rate and duration of diarrhea. The GRADE tool was used to assess the quality of evidence. Results: A total of 38 randomized controlled trials were included involving 3948 participants (including 27 trials on 2702 children) were included. Compared with antibiotics, berberine plus antibiotics showed better results in both adults and in children in general, especially when given for 7 days or 3 days in acute infectious diarrhea of children. Compared with the control groups, using berberine alone or in combination with montmorillonite, probiotics, and vitamin B increased the clinical cure rate of diarrhea. The use of berberine alone or berberine combined with montmorillonite reduced the duration of hospitalization. Using berberine had significantly better laboratory indicators (isoenzyme, inflammatory factors, myocardial enzyme, and fecal trait) and fewer systemic symptoms than the no berberine groups. Overall, 22 of 27 trials on children used berberine as an enema. No deaths and serious adverse events were reported. The quality of evidence of included trials was moderate to low or very low. The impact of different dosages, frequencies and treatment durations on the outcomes was not evaluated due to insufficient number of trials. Conclusion: This review demonstrated that berberine was generally effective in improving clinical cure rates and shortening the duration of diarrhea compared with control groups. No severe adverse event was reported. However, there is still a lack of high-quality evidence for evaluating the efficacy and safety of berberine. Trial registration: PROSPERO CRD42020151001 (available from http://www.crd.york.ac.uk/PROSPERO/ ).

scholarly journals The Use of Platelet-Rich Plasma for Treatment of Tenodesmic Lesions in Horses: A Systematic Review and Meta-Analysis of Clinical and Experimental Data

Animals ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. 793
Author(s):  
Chiara Montano ◽  
Luigi Auletta ◽  
Adelaide Greco ◽  
Dario Costanza ◽  
Pierpaolo Coluccia ◽  
...  
Keyword(s):  
Systematic Review ◽  
Platelet Rich Plasma ◽  
Meta Analysis ◽  
Inclusion Criteria ◽  
Control Groups ◽  
Definitive Evidence ◽  
Dichotomous Data ◽  
And Control ◽  
Risk Ratios

The use of platelet-rich plasma (PRP) to enhance tenodesmic lesion healing has been questioned over the years. The aim of this study was to evaluate current literature to establish the effectiveness of PRP for treating tenodesmic lesions through a systematic review, in accordance with the PRISMA guidelines, and a meta-analysis. Studies comparing PRP with placebo or other treatments for horses with tenodesmic injuries or evaluated PRP effect on tendon and ligament explants were included. Outcomes were clinical, ultrasound, histologic, molecular evaluation, and adverse effects. Two authors independently extracted data and assessed each study’s risk of bias. Treatment effects were evaluated using risk ratios for dichotomous data, together with 95% CI. Data were pooled using the random-effects model. The quality of the evidence for each outcome was assessed using GRADE criteria. Twenty-four trials met inclusion criteria for systematic review, while fifteen studies were included in the meta-analysis. Results showed no significant differences in the outcomes between PRP and control groups. Finally, there is no definitive evidence that PRP enhances tendons and ligaments healing. Therefore, there is a need for more controlled trials to draw a firmer conclusion about the efficacy of PRP as a treatment for tenodesmic lesions in the horse.

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