scholarly journals Son of a Lesser God: The Case of Cell Therapy for Refractory Angina

2021 ◽  
Vol 8 ◽  
Author(s):  
Beatrice Bassetti ◽  
Erica Rurali ◽  
Elisa Gambini ◽  
Giulio Pompilio
Keyword(s):  
Clinical Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Evidence Based ◽  
Refractory Angina ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Recommended Treatment ◽  
Meta Analyses ◽  
Current Guidelines

In the last decades, various non-pharmacological solutions have been tested on top of medical therapy for the treatment of patients affected by refractory angina (RA). Among these therapeutics, neuromodulation, external counter-pulsation and coronary sinus constriction have been recently introduced in the guidelines for the management of RA in United States and Europe. Notably and paradoxically, although a consistent body of evidence has proposed cell-based therapies (CT) as safe and salutary for RA outcome, CT has not been conversely incorporated into current international guidelines yet. As a matter of fact, published randomized controlled trials (RCT) and meta-analyses (MTA) cumulatively indicated that CT can effectively increase perfusion, physical function and well-being, thus reducing angina symptoms and drug assumption in RA patients. In this review, we (i) provide an updated overview of novel non-pharmacological therapeutics included in current guidelines for the management of patients with RA, (ii) discuss the Level of Evidence stemmed from available clinical trials for each recommended treatment, and (iii) focus on evidence-based CT application for the management of RA.

Trends in randomized controlled trials in ENT: a 30-year review

1997 ◽  
Vol 111 (7) ◽  
pp. 611-613 ◽  
Author(s):  
K. W. Ah-See ◽  
N. C. Molony ◽  
A. G. D. Maran
Keyword(s):  
Clinical Trials ◽  
Clinical Practice ◽  
Randomized Controlled Trials ◽  
Gold Standard ◽  
Controlled Trials ◽  
Evidence Based ◽  
Controlled Clinical Trials ◽  
Medline Search ◽  
Randomized Controlled Clinical Trials ◽  
Randomized Controlled

AbstractThere is a growth in the demand for clinical practice to be evidence based. Recent years have seen a rise in the number of randomized controlled clinical trials (RCTS). Such trials while acknowledged as the gold standard for evidence can be difficult to perform in surgical specialities. We have recently identified a low proportion of RCTS in the otolaryngology literature. Our aim was to identify any trend in the number of published RCTS within the ENT literature over a 30-year period and to identify which areas of our speciality lend themselves to this form of study design. A Medline search of 10 prominent journals published between 1966 and 1995 was performed. Two hundred and ninety-six RCTS were identified. Only five were published before 1980. Two hundred (71 per cent) of RCTS were in the areas of otology and rhinology. An encouraging trend is seen in RCTS within ENT literature.

Randomized Controlled Trials in the Evaluation of Antenatal Care

1992 ◽  
Vol 8 (S1) ◽  
pp. 40-45 ◽  
Author(s):  
Murray W. Enkin
Keyword(s):  
Clinical Trials ◽  
Antenatal Care ◽  
Randomized Controlled Trials ◽  
Perinatal Outcome ◽  
Randomized Clinical Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Adverse Perinatal Outcome ◽  
Randomized Controlled

AbstractMany of the practices carried out during antenatal care improve the well-being of mother or baby and reduce the burden of adverse perinatal outcome. Other practices have either not been evaluated or have been shown to be ineffective. Evidence from randomized clinical trials provides the best evidence about the effectiveness of these practices.

scholarly journals Assessing the risk of bias in randomized controlled trials in the field of dentistry indexed in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database

2011 ◽  
Vol 129 (2) ◽  
pp. 85-93 ◽  
Author(s):  
Christiane Alves Ferreira ◽  
Carlos Alfredo Salles Loureiro ◽  
Humberto Saconato ◽  
Álvaro Nagib Atallah
Keyword(s):  
Randomized Controlled Trials ◽  
Research Question ◽  
Allocation Concealment ◽  
Risk Of Bias ◽  
Low Risk ◽  
Controlled Trials ◽  
Level Of Evidence ◽  
Randomized Controlled ◽  
Decision Making Processes ◽  
Meta Analyses

CONTEXT AND OBJECTIVE: Well-conducted randomized controlled trials (RCTs) represent the highest level of evidence when the research question relates to the effect of therapeutic or preventive interventions. However, the degree of control over bias between RCTs presents great variability between studies. For this reason, with the increasing interest in and production of systematic reviews and meta-analyses, it has been necessary to develop methodology supported by empirical evidence, so as to encourage and enhance the production of valid RCTs with low risk of bias. The aim here was to conduct a methodological analysis within the field of dentistry, regarding the risk of bias in open-access RCTs available in the Lilacs (Literatura Latino-Americana e do Caribe em Ciências da Saúde) database. DESIGN AND SETTING: This was a methodology study conducted at Universidade Federal de São Paulo (Unifesp) that assessed the risk of bias in RCTs, using the following dimensions: allocation sequence generation, allocation concealment, blinding, and data on incomplete outcomes. RESULTS: Out of the 4,503 articles classified, only 10 studies (0.22%) were considered to be true RCTs and, of these, only a single study was classified as presenting low risk of bias. The items that the authors of these RCTs most frequently controlled for were blinding and data on incomplete outcomes. CONCLUSION: The effective presence of bias seriously weakened the reliability of the results from the dental studies evaluated, such that they would be of little use for clinicians and administrators as support for decision-making processes.

Selection and Evaluation of Empirical Research in Technology Assessment

1989 ◽  
Vol 5 (4) ◽  
pp. 521-536 ◽  
Author(s):  
Thomas C. Chalmers ◽  
Peg Hewett ◽  
Dinah Reitman ◽  
Henry S. Sacks
Keyword(s):  
Clinical Trials ◽  
Technology Assessment ◽  
Scientific Method ◽  
Meta Analysis ◽  
Sensitivity Analyses ◽  
Controlled Trials ◽  
Data Bases ◽  
Randomized Controlled ◽  
Practice Of Medicine ◽  
Meta Analyses

Technology assessment involves application of the scientific method to the practice of medicine. Finding all of the assessment reports in a given field is not an easy task. Proper evaluation of those assessments requires the conduct of a prospective experiment in which the sources and results are blinded when the choice is made of papers to exclude and to include, and the process should be carried in duplicate. There are several available data bases for carrying out the search, but because of problems they should be supplemented by reference to the bibliographies of pertinent published articles. Clinical trials included in meta-analyses should be graded by quality and thus facilitate sensitivity analyses. Attention must be paid to the possibility of publication bias. Finally, the advent of meta-analysis makes it desirable to begin randomized controlled trials in areas of uncertainty, even when there is no possibility that individual investigators will encounter enough patients to draw valid conclusions.

scholarly journals Physical Exercise for Patients Undergoing Hematopoietic Stem Cell Transplantation: Systematic Review and Meta-Analyses of Randomized Controlled Trials

2013 ◽  
Vol 93 (4) ◽  
pp. 514-528 ◽  
Author(s):  
Inge E.P.M. van Haren ◽  
Hans Timmerman ◽  
Carin M. Potting ◽  
Nicole M.A. Blijlevens ◽  
J. Bart Staal ◽  
...  
Keyword(s):  
Physical Exercise ◽  
Data Extraction ◽  
Well Being ◽  
Risk Of Bias ◽  
Controlled Trials ◽  
Psychological Well Being ◽  
Hematopoietic Stem ◽  
Exercise Interventions ◽  
Randomized Controlled ◽  
Meta Analyses

Background The treatment-related burden for patients undergoing hematopoietic stem cell transplantation (HSCT) may be relieved by physical exercises. Purpose The purpose of this study was to summarize and analyze the evidence provided by randomized controlled trials (RCTs) on physical exercise interventions among patients with cancer undergoing HSCT. Data Sources PubMed, CINAHL, EMBASE, the Cochrane Library, and PEDro were searched for relevant RCTs up to October 1, 2011. Study Selection Two reviewers screened articles on inclusion criteria and indentified relevant RCTs. Data Extraction Two authors assessed the selected articles for risk of bias. Data extraction was performed by 1 reviewer. Meta-analyses were undertaken to estimate the outcomes quality of life (QOL), psychological well-being and distress, and fatigue. Data Synthesis Eleven studies were included, with study populations consisting of recipients undergoing either an allogeneic or autologous HSCT (n=734). Four studies had low risk of bias. The exercise interventions were performed before, during, and after hospitalization for the HSCT. Different exercise programs on endurance, resistance and/or activities of daily living training, progressive relaxation, and stretching were used. Meta-analyses showed that exercise during hospitalization led to a higher QOL (weighted mean difference=8.72, 95% confidence interval=3.13, 14.31) and less fatigue (standardized mean difference=0.53, 95% confidence interval=0.16, 0.91) in patients with an allogeneic HSCT at the moment of discharge from the hospital. No marked effects were found for psychological well-being and distress. Individual study results suggested significant positive effects on QOL, fatigue, psychological well-being and distress, and physical functioning. Limitations Prevalent shortcomings in the included studies were the heterogeneity among studies and the lack of blinding of participants, personnel, and outcome assessment. Conclusions The results suggest that recipients of HSCT may benefit from physical exercise.

Levels of evidence of articles in podiatric medical journals

2000 ◽  
Vol 90 (6) ◽  
pp. 300-302 ◽  
Author(s):  
MA Turlik ◽  
D Kushner
Keyword(s):  
Randomized Controlled Trials ◽  
Evidence Based Medicine ◽  
Medical Profession ◽  
Controlled Trials ◽  
Evidence Based ◽  
Level Of Evidence ◽  
Medical Journals ◽  
Levels Of Evidence ◽  
Randomized Controlled ◽  
Based Medicine

The authors reviewed 322 articles in podiatric medical journals to determine their level of evidence. Only 1% of the articles reviewed were randomized controlled trials. The authors concluded that if the podiatric medical profession wishes to become a participant in evidence-based medicine, greater emphasis must be placed on studies that assess hypotheses.

scholarly journals AB0766 ACCURACY OF PATIENT REPORTED OUTCOME REPORTING IN RANDOMIZED CONTROLLED TRIALS IN PSORIATIC ARTHRITIS

2020 ◽  
Vol 79 (Suppl 1) ◽  
pp. 1681.2-1681
Author(s):  
B. Frade-Sosa ◽  
A. Kerschbaumer ◽  
P. Studenic ◽  
E. Chwala ◽  
J. S. Smolen ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Psoriatic Arthritis ◽  
Randomized Controlled Trials ◽  
Well Being ◽  
Controlled Trials ◽  
Research Support ◽  
Randomized Controlled ◽  
Patient Reported

Background:Patient-reported outcomes (PROs) allow incorporating the patient’s perspective and health related quality of life (HRQoL) into shared decision making when choosing the optimal treatment strategy in patients suffering from psoriatic arthritis (PsA). PsA is a chronic inflammatory disease with heterogeneous manifestations with a range of symptoms, co-morbidities and reduced quality of life. International working groups (1) emphasized to integrate these outcomes as endpoints in clinical trials and as part of the core set of measures.Objectives:To evaluate the quality of PRO reporting in randomized clinical trials in PsA.Methods:We conducted a systematic literature review (PROSPERO ID 160930) searching PUBMED, MEDLINE and the Cochrane Library for publications (in English language) on randomized controlled trials investigating biological or targeted synthetic disease modifying drugs in adult PsA patients that included some PROs to evaluate the response to treatment. Two of the authors (BFS, AK) screened, selected and extracted the data of the trials that fulfilled inclusion criteria. Statistics were descriptive.Results:Of 1392 articles in total 880 were screened (512 duplicates); 92 were selected for detailed analysis with 48 finally analysed. 87% were primary publications were some patient-outcome measure were reported. The Health Assessment Questionnaire Disability Index (HAQ-DI) was reported in all RCTs (100%), while 70% of trials reported on the Short Form (36) Health Survey (SF36). Fatigue (FACIT-F) was reported in 29% of trials with different rates of articles published before and after the OMERACT working group recommendations (27% vs 50%) (1). Data on burden of psoriasis through the Dermatology Life Quality Index in 45%. Other PRO measurements to assess potentially affected health domains such as sleep disturbance, psychological disorders or well-being at work were reported only rarely.Conclusion:Our SLR shows that all trials report data on HAQ-DI. However, important domains as also emphasized by the OMERACT working group (1) are not routinely reported. Especially fatigue, included in 2016 as part of the OMERACT “Inner core” of the PsA Core Domain Set is only reported in about one quarter of studies, although 50% of studies published after 2016 report on fatigue. Data on emotional well-being, psychological status, productivity losses, and sleep disturbance remain rarely reported in PsA randomized controlled trials.References:[1]Orbai A, de Wit M, Mease P, et al International patient and physician consensus on a psoriatic arthritis core outcome set for clinical trials. Annals of the Rheumatic Diseases 2017;76:673-680.Acknowledgments:Acknowledgements: The author BFS had received an economic grant from the Spanish Society of Rheumatology (FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research) and the Catalan Society of Rheumatology (BequesNovartis de formació per estades a l’estranger) for the research stay in Vienna (Austria).Disclosure of Interests:Beatriz Frade-Sosa Grant/research support from: FER KERN-PHARMA Scholarships for Short stays: Plan for the promotion of research. BequesNovartis de formació per estades a l’estranger, Andreas Kerschbaumer Paid instructor for: Celgene, Speakers bureau: Andreas Kerschbaumer has received lecture fees from Bristol-Myers Squibb, Gilead, Merck Sharp and Dohme and Pfizer., Paul Studenic Grant/research support from: Abbvie, Eva Chwala: None declared, Josef S. Smolen Grant/research support from: AbbVie, Eli Lilly, Janssen, Merck Sharp & Dohme, Pfizer, Roche – grant/research support, Consultant of: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – consultant, Speakers bureau: AbbVie, Amgen Inc., AstraZeneca, Astro, Celgene Corporation, Celtrion, Eli Lilly, Glaxo, ILTOO, Janssen, Medimmune, Merck Sharp & Dohme, Novartis, Pfizer, Roche, Samsung, Sanofi, UCB – speaker, Daniel Aletaha Grant/research support from: AbbVie, Novartis, Roche, Consultant of: AbbVie, Amgen, Celgene, Lilly, Medac, Merck, Novartis, Pfizer, Roche, Sandoz, Sanofi Genzyme, Speakers bureau: AbbVie, Celgene, Lilly, Merck, Novartis, Pfizer, Sanofi Genzyme, UCB

scholarly journals Follicular Fluid Meiosis-Activating Sterol in Assisted Reproductive Techniques: A Systematic Review and Meta-analysis of Randomized Controlled Trials

2020 ◽  
pp. 1-16
Author(s):  
Kien Nguyen Dang ◽  
Mohammad Rashidul Hashan ◽  
Le Huu Nhat Minh ◽  
Khalid Muhammad Khalaf ◽  
Hassan Yousif Ibrahim ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Randomized Controlled Trials ◽  
Follicular Fluid ◽  
Meta Analysis ◽  
Normal Embryo ◽  
Controlled Trials ◽  
Abnormal Embryo ◽  
Randomized Controlled ◽  
Mosaic Embryo ◽  
Meta Analyses

Background: Follicular fluid meiosis-activating sterol (FFMAS) is one of several molecular compounds that has been added into in vitro maturation (IVM) technique with contradictory results. Our study aimed to investigate the effects of FFMAS in assisted reproductive technology (ART). Methods: We searched systematically in PubMed, Web of Science, Scopus, Cochrane Registry of clinical trials, WHO registry of clinical trials, clinicaltrials.gov, Google Scholar until July 2017. Meta-analysis was used to investigate the efficacy and safety outcomes of FFMAS. Following the retrieval of potential articles, two independent reviewers screened and extracted included papers rigorously. Summary odds ratios (ORs) and 95% confidence intervals (CIs) were computed for the individual outcome when data was available. Quality of included studies was assessed using Cochrane collaboration tool. Results: A total of seven randomized controlled trials involving 1198 participants with 3105 oocytes were explored in this study. Most of the studies were at low risk of bias. Our random effects model meta-analyses in maturation and abnormal embryo rate between FFMAS-exposed oocytes compared with controls revealed no significant differences (summary OR 1.00, 95% CI 0.46–2.16, [Formula: see text] value = 0.99 and summary OR was 1.31, 95% CI 0.84–2.04, [Formula: see text] value = 0.23, respectively). Beside, our study showed a significant increase in uniformly abnormal embryo rate in FFMAS group compared with vehicle control group (summary OR 1.98, 95% CI 1.09–3.61, [Formula: see text] value = 0.03). No significances were noted on meta-analyses of normal embryo rate, uniformly abnormal embryo rate, uniformly normal embryo rate, mosaic embryo rate, abnormal blastomere rate, normal blastomere rate, aneuploidy mosaic embryo rate, and chaotic mosaic embryo rate. Conclusions: FFMAS showed no efficacy in maturation process in human oocytes and there was some evidence for detrimental effects in comparison to vehicle controls. We discouraged any further trials due to safety concern.

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