scholarly journals Intensive Triangulation of Qualitative Research and Quantitative Data to Improve Recruitment to Randomized Trials: The QuinteT Approach

2019 ◽  
Vol 29 (5) ◽  
pp. 672-679 ◽  
Author(s):  
Leila Rooshenas ◽  
Sangeetha Paramasivan ◽  
Marcus Jepson ◽  
Jenny L. Donovan
Keyword(s):  
Qualitative Research ◽  
Comparative Effectiveness ◽  
Quantitative Data ◽  
Randomized Trials ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
Health Care Interventions ◽  
High Quality Evidence ◽  
Quality Evidence

Randomized controlled trials (RCTs) can provide high quality evidence about the comparative effectiveness of health care interventions, but many RCTs struggle with or fail to complete recruitment. RCTs are built on the principles of the experimental method, but their planning, conduct, and interpretation can depend on complex social, behavioral, and cultural factors that may be best understood through qualitative research. Most qualitative studies undertaken alongside RCTs involve interviews that produce data that are used in a supportive or supplicatory role, but there is potential for qualitative research to be more influential. In this article, we describe the research methods underpinning the “QuinteT” (Qualitative Research Integrated Within Trials) approach to understand and address RCT recruitment difficulties. The QuinteT Recruitment Intervention (QRI) brings together multiple qualitative strategies and quantitative data and uses triangulation to understand recruitment issues rapidly. These nuanced understandings are used to inform the implementation of collaborative actions to improve recruitment.

scholarly journals TRADE-OFFS BETWEEN EPISTEMIC AND MORAL VALUES IN EVIDENCE-BASED POLICY

2018 ◽  
Vol 35 (1) ◽  
pp. 49-78 ◽  
Author(s):  
Donal Khosrowi
Keyword(s):  
Controlled Trials ◽  
Evidence Based ◽  
Epistemic Values ◽  
High Quality ◽  
Political Values ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Evidence Based Policy ◽  
Trade Offs ◽  
Quality Evidence

Abstract:Proponents of evidence-based policy (EBP) call for public policy to be informed by high-quality evidence from randomized controlled trials. This methodological preference aims to promote several epistemic values, e.g. rigour, unbiasedness, precision, and the ability to obtain causal conclusions. I argue that there is a trade-off between these epistemic values and several non-epistemic, moral and political values. This is because the evidence afforded by standard EBP methods is differentially useful for pursuing different moral and political values. I expand on how this challenges ideals of value-freedom and -neutrality in EBP, and offer suggestions for how EBP methodology might be revised.

scholarly journals Therapeutic Evidence of Human Mesenchymal Stem Cell Transplantation for Cerebral Palsy: A Meta-Analysis of Randomized Controlled Trials

2020 ◽  
Vol 2020 ◽  
pp. 1-10
Author(s):  
Baocheng Xie ◽  
Minyi Chen ◽  
Runkai Hu ◽  
Weichao Han ◽  
Shaobo Ding
Keyword(s):  
Cerebral Palsy ◽  
Stem Cell ◽  
Mesenchymal Stem Cell ◽  
Meta Analysis ◽  
Human Mesenchymal Stem Cell ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Quality Evidence

Cerebral palsy (CP) is a kind of movement and posture disorder syndrome in early childhood. In recent years, human mesenchymal stem cell (hMSC) transplantation has become a promising therapeutic strategy for CP. However, clinical evidence is still limited and controversial about clinical efficacy of hMSC therapy for CP. Our aim is to evaluate the efficacy and safety of hMSC transplantation for children with CP using a meta-analysis of randomized controlled trials (RCTs). We conducted a systematic literature search including Embase, PubMed, ClinicalTrials.gov, Cochrane Controlled Trials Register databases, Chinese Clinical Trial Registry, and Web of Science from building database to February 2020. We used Cochrane bias risk assessment for the included studies. The result of pooled analysis showed that hMSC therapy significantly increased gross motor function measure (GMFM) scores (standardized mean difference SMD=1.10, 95%CI=0.66‐1.53, P<0.00001, high-quality evidence) and comprehensive function assessment (CFA) (SMD=1.30, 95%CI=0.71‐1.90, P<0.0001, high-quality evidence) in children with CP, compared with the control group. In the subgroup analysis, the results showed that hMSC therapy significantly increased GMFM scores of 3, 6, and 12 months and CFA of 3, 6, and 12 months. Adverse event (AE) of upper respiratory infection, diarrhea, and constipation was not statistically significant between the two groups. This meta-analysis synthesized the primary outcomes and suggested that hMSC therapy is beneficial, effective, and safe in improving GMFM scores and CFA scores in children with CP. In addition, subgroup analysis showed that hMSC therapy has a lasting positive benefit for CP in 3, 6, and 12 months.

scholarly journals Structural Allograft Versus PEEK Implants in Anterior Cervical Discectomy and Fusion: A Systematic Review

2019 ◽  
Vol 10 (6) ◽  
pp. 775-783
Author(s):  
Amit Jain ◽  
Majd Marrache ◽  
Andrew Harris ◽  
Varun Puvanesarajah ◽  
Brian J. Neuman ◽  
...  
Keyword(s):  
Systematic Review ◽  
Patient Reported Outcomes ◽  
Controlled Trials ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Structural Allograft ◽  
Patient Reported ◽  
Spine Degeneration ◽  
Quality Evidence

Study Design: Systematic literature review. Objective: Our primary objective was to compare reported fusion rates after anterior cervical discectomy and fusion (ACDF) using structural allograft versus polyetheretherketone (PEEK) interbody devices in patients with cervical spine degeneration. Our secondary objectives were to compare differences in rates of subsidence and reoperation and in patient-reported outcomes between the 2 groups. Methods: Through a systematic review of the English-language literature using various databases, we identified 4702 articles. After we applied inclusion and exclusion criteria, 14 articles (7 randomized controlled trials, 4 prospective studies, and 3 retrospective studies) reporting fusion rates of structural allograft or PEEK interbody devices were eligible for our analysis. No randomized controlled trials compared outcomes of structural allograft versus PEEK interbody devices. Extracted data included authors, study years, study designs, sample sizes, patient ages, duration of follow-up, types of interbody devices used, fusion rates, definition of fusion, reoperation rates, subsidence rates, and patient-reported outcomes. Results: Fusion rates were 82% to 100% for allograft and 88% to 98% for PEEK interbody devices. The reported data were insufficient to perform meta-analysis. Structural allograft had the highest reported rate of reoperation (14%), and PEEK interbody devices had the highest reported subsidence rate (18%). Patient-reported outcomes improved in both groups. There was insufficient high-quality evidence to compare the associations of various PEEK modifications with fusion rates. Conclusion: Fusion rates were similar between structural allograft and PEEK interbody devices when used for ACDF for cervical spine degeneration. Currently, there is insufficient high-quality evidence to assess associations of PEEK modifications with fusion rates. Level of Evidence: II.

scholarly journals Normalising comparative effectiveness trials as clinical practice

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Tom Briffa ◽  
Tanya Symons ◽  
Nikolajs Zeps ◽  
Nicola Straiton ◽  
William Odita Tarnow-Mordi ◽  
...  
Keyword(s):  
Clinical Practice ◽  
Comparative Effectiveness ◽  
Practice Variation ◽  
High Quality ◽  
Diverse Range ◽  
Implementation Challenges ◽  
High Quality Evidence ◽  
Real World Evidence ◽  
Effectiveness Trials ◽  
Quality Evidence

AbstractThere is a lack of high-quality evidence underpinning many contemporary clinical practice guidelines embedded in the healthcare systems, leading to treatment uncertainty and practice variation in most medical disciplines. Comparative effectiveness trials (CETs) represent a diverse range of research that focuses on optimising health outcomes by comparing currently approved interventions to generate high-quality evidence to inform decision makers. Yet, despite their ability to produce real-world evidence that addresses the key priorities of patients and health systems, many implementation challenges exist within the healthcare environment.This manuscript aims to highlight common barriers to conducting CETs and describes potential solutions to normalise their conduct as part of a learning healthcare system.

scholarly journals Management of Spinal Deformities and Evidence of Treatment Effectiveness

2017 ◽  
Vol 11 (1) ◽  
pp. 1521-1547 ◽  
Author(s):  
Josette Bettany-Saltikov ◽  
Deborah Turnbull ◽  
Shu Yan Ng ◽  
Richard Webb
Keyword(s):  
Surgical Treatment ◽  
Conservative Treatment ◽  
Idiopathic Scoliosis ◽  
Adult Scoliosis ◽  
Controlled Trials ◽  
Spinal Deformities ◽  
High Quality ◽  
High Quality Evidence ◽  
Adolescents And Adults ◽  
Quality Evidence

Introduction:The review evaluates the up-to-date evidence for the treatment of spinal deformities, including scoliosis and hyperkyphosis in adolescents and adults.Material and Methods:The PubMed database was searched for review articles, prospective controlled trials and randomized controlled trials related to the treatment of spinal deformities. Articles on syndromic scoliosis were excluded and so were the articles on hyperkyphosis of the spine with causes other than Scheuermann’s disease and osteoporosis. Articles on conservative and surgical treatments of idiopathic scoliosis, adult scoliosis and hyperkyphosis were also included. For retrospective papers, only studies with a follow up period exceeding 10 years were included.Results:The review showed that early-onset idiopathic scoliosis has a worse outcome than late-onset idiopathic scoliosis, which is rather benign. Patients with AIS function well as adults; they have no more health problems when compared to patients without scoliosis, other than a slight increase in back pain and aesthetic concern. Conservative treatment of adolescent idiopathic scoliosis (AIS) using physiotherapeutic scoliosis-specific exercises (PSSE), specifically PSSR and rigid bracing was supported by level I evidence. Yet to date, there is no high quality evidence (RCT`s) demonstrating that surgical treatment is superior to conservative treatment for the management of AIS. For adult scoliosis, there are only a few studies on the effectiveness of PSSEs and a conclusion cannot as yet be drawn.For hyperkyphosis, there is no high-quality evidence for physiotherapy, bracing or surgery for the treatment of adolescents and adults. However, bracing has been found to reduce thoracic hyperkyphosis, ranging from 55 to 80° in adolescents. In patients over the age of 60, bracing improves the balance score, and reduces spinal deformity and pain. Surgery is indicated in adolescents and adults in the presence of progression of kyphosis, refractory pain and loss of balance.Discussion:The available evidence reviewed has suggested that different approaches are needed towards the management of different spinal deformities. Specific exercises should be prescribed in children and adolescents with a Cobb angle in excess of 15°. In progressive curves, they should be used in conjunction with bracing. Clarity regarding differences and similarities is given as to what makes PSSE and PSSR specific exercises. As AIS is relatively benign in nature, conservative treatment should be tried when the curve is at a surgical threshold, before surgery is considered. Similarly, bracing and exercises should be prescribed for patients with hyperkyphosis, particularly when the lumbar spine is afflicted. Surgery should be considered only when the symptoms cannot be managed conservatively.Conclusion:There is at present high quality evidence in support of the conservative treatment of AIS. The current evidence supports the use of PSSE, especially those using PSSR, together with bracing in the treatment of AIS. In view of the lack of medical consequences in adults with AIS, conservative treatment should be considered for curves exceeding the formerly assumed range of conservative indications.There is, however a lack of evidence in support of any treatment of choice for hyperkyphosis in adolescents and spinal deformities in adults. Yet, conservative treatment should be considered first. Yet to date, there is no high quality evidence (RCT`s) demonstrating that surgical treatment is superior to conservative treatment for the management of AIS and hyperkyphosis. Additionally, surgery needs to be considered with caution, as it is associated with a number of long-term complications.

scholarly journals The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled, multicenter trial.

2020 ◽  
Author(s):  
Tao Bai ◽  
Haoyu Zeng ◽  
Yanqin Long ◽  
Xiaoqing Li ◽  
Xiaohong Sun ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Controlled Trial ◽  
Control Group ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Multicenter Randomized Controlled Trial ◽  
Irritable Bowel ◽  
Experimental Group ◽  
Quality Evidence

Abstract Background: Irritable bowel syndrome (IBS) is one of the most acommon functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients’ quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy, however, in a lack of high-quality evidence of efficacy, no specific strain- and dose-probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the bifidobacterium quadruple viable tablet in the treatment of IBS-D.Methods/design: A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients fulfill the eligible criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency, the secondary outcome include evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events and concomitant medication will be taken into account for intervention safety assessment during the trial.Discussion: This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotics intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis.Trial registration: Chinese Clinical Trial Registry, ID: ChiCTR1800017721 ( http://www.chictr.org.cn/showproj.aspx?proj=29440 ). Registered on 10 August 2018.

scholarly journals The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled, multicenter trial.

2019 ◽  
Author(s):  
Haoyu Zeng ◽  
Tao Bai ◽  
Yanqin Long ◽  
Xiaoqing Li ◽  
Xiaohong Sun ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Controlled Trial ◽  
Control Group ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Multicenter Randomized Controlled Trial ◽  
Irritable Bowel ◽  
Experimental Group ◽  
Quality Evidence

Abstract Background Irritable bowel syndrome (IBS) is one of the most acommon functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients’ quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy, however, in a lack of high-quality evidence of efficacy, no specific strain- and dose-probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the bifidobacterium quadruple viable tablet in the treatment of IBS-D. Methods/design A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients fulfill the eligible criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency, the secondary outcome include evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events and concomitant medication will be taken into account for intervention safety assessment during the trial. Discussion This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotics intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis.

scholarly journals Don’t abandon RCTs in IVF. We don’t even understand them

2019 ◽  
Vol 34 (11) ◽  
pp. 2093-2098 ◽  
Author(s):  
J Wilkinson ◽  
D R Brison ◽  
J M N Duffy ◽  
C M Farquhar ◽  
S Lensen ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Status Quo ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Infertility Treatments ◽  
The Status ◽  
Quality Evidence

Abstract The conclusion of the Human Fertilisation and Embryology Authority that ‘add-on’ therapies in IVF are not supported by high-quality evidence has prompted new questions regarding the role of the randomized controlled trial (RCT) in evaluating infertility treatments. Critics argue that trials are cumbersome tools that provide irrelevant answers. Instead, they argue that greater emphasis should be placed on large observational databases, which can be analysed using powerful algorithms to determine which treatments work and for whom. Although the validity of these arguments rests upon the sciences of statistics and epidemiology, the discussion to date has largely been conducted without reference to these fields. We aim to remedy this omission, by evaluating the arguments against RCTs in IVF from a primarily methodological perspective. We suggest that, while criticism of the status quo is warranted, a retreat from RCTs is more likely to make things worse for patients and clinicians.

scholarly journals The efficacy of Bifidobacterium quadruple viable tablet in the treatment of diarrhea predominant irritable bowel syndrome: a randomized, double-blind, placebo-controlled, multicenter trial.

2019 ◽  
Author(s):  
Haoyu Zeng ◽  
Tao Bai ◽  
Yanqin Long ◽  
Xiaoqing Li ◽  
Xiaohong Sun ◽  
...  
Keyword(s):  
Safety Assessment ◽  
Controlled Trial ◽  
Control Group ◽  
High Quality ◽  
Randomized Controlled ◽  
High Quality Evidence ◽  
Multicenter Randomized Controlled Trial ◽  
Irritable Bowel ◽  
Experimental Group ◽  
Quality Evidence

Abstract Background: Irritable bowel syndrome (IBS) is one of the most acommon functional gastrointestinal disorders characterized by recurrent abdominal pain associated with defecation or a change in bowel habits. Leading to significant negative effect on patients’ quality of life and huge financial burden to health system, the management of IBS is a great challenge. Probiotics are considered as an effective therapy, however, in a lack of high-quality evidence of efficacy, no specific strain- and dose-probiotics were recommended in clinical guidelines. This study aims to evaluate the efficacy of the bifidobacterium quadruple viable tablet in the treatment of IBS-D. Methods/design: A multicenter randomized controlled trial will be performed in fourteen hospitals. A total of three hundred patients fulfill the eligible criteria will be stratified divided into an experimental group and a control group randomly in a ratio of 1:1. The experimental group is treated with the bifidobacterium quadruple viable tablet while the control group is treated with placebo. All the patients will receive a 4-week treatment and a 2-week follow-up. The primary outcome is the effectiveness in improving abdominal pain and stool consistency, the secondary outcome include evaluation of overall symptom relief, frequency of defecation, bloating, urgency of defecation, remedial medication, score of IBS-QOL and changes of microbiota and metabonomics. Physical examination, vital signs, laboratory tests, adverse events and concomitant medication will be taken into account for intervention safety assessment during the trial. Discussion: This multicenter randomized controlled trial may provide high-quality evidence on the efficacy of the bifidobacterium quadruple viable tablet for IBS-D on both physical and mental dimensions in China. To fill the gap of previous probiotics intervention studies, in addition, this study will also present safety assessment which will be a significant emphasis.

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