Can quality of clinical trials and meta-analyses be quantified?

The Lancet ◽  
1998 ◽  
Vol 352 (9128) ◽  
pp. 590 ◽  
Author(s):  
John PA Ioannidis ◽  
Joseph Lau
Keyword(s):  
Clinical Trials ◽  
Meta Analyses

scholarly journals Comparative clinical trials in psychotherapy: Have large effects been replicated?

2020 ◽  
Vol 29 ◽  
Author(s):  
Nickolas D. Frost ◽  
Thomas W. Baskin ◽  
Bruce E. Wampold
Keyword(s):  
Clinical Trials ◽  
Treatment Efficacy ◽  
Literature Search ◽  
Meta Analysis ◽  
Effect Sizes ◽  
Depression And Anxiety ◽  
Inclusion Criteria ◽  
Average Quality ◽  
Meta Analyses

Abstract Aims The purpose of this review is to examine the replication attempts of psychotherapy clinical trials for depression and anxiety. We focus specifically on replications of trials that exhibit large differences between psychotherapies. The replicability of these trials is especially important for meta-analysis, where the inclusion of false-positive trials can lead to erroneous conclusions about treatment efficacy. Methods Standard replication criteria were developed to distinguish direct from conceptual replication methodologies. Next, an exhaustive literature search was conducted for published meta-analyses of psychotherapy comparisons. Trials that exhibited large effects (d > 0.8) were culled from these meta-analyses. For each trial, a cited replication was conducted to determine if the trial had been subsequently replicated by either ‘direct’ or ‘conceptual’ methods. Finally, a broader search was conducted to examine the extent of replication efforts in the psychotherapy literature overall. Results In the meta-analytic search, a total of N = 10 meta-analyses met the inclusion criteria. From these meta-analyses, N = 12 distinct trials exhibited large effect sizes. The meta-analyses containing more than two large effect trials reported evidence for treatment superiority. A cited replication search yielded no direct replication attempts (N = 0) for the trials with large effects, and N = 4 conceptual replication attempts of average or above average quality. However, of these four attempts, only two partially corroborated the results from their original trial. Conclusion Meta-analytic reviews are influenced by trials with large effects, and it is not uncommon for these reviews to contain several such trials. Since we find no evidence that trials with such large effects are directly replicable, treatment superiority conclusions from these reviews are highly questionable. To enhance the quality of clinical science, the development of authoritative replication criteria for clinical trials is needed. Moreover, quality benchmarks should be considered before trials are included in a meta-analysis, or replications are attempted.

scholarly journals Effects of Music Therapy on Patients with Dementia—A Systematic Review

Geriatrics ◽  
2020 ◽  
Vol 5 (4) ◽  
pp. 62
Author(s):  
Hei Long Lam ◽  
Wai Tak Victor Li ◽  
Ismail Laher ◽  
Roger Y. Wong
Keyword(s):  
Quality Of Life ◽  
Clinical Trials ◽  
Music Therapy ◽  
Large Scale ◽  
Psychological Symptoms ◽  
Cognitive Outcomes ◽  
Improved Outcomes ◽  
Potential Benefits ◽  
Meta Analyses

Dementia is an increasingly common syndrome and while pharmacotherapy is available, its potential benefit is limited, especially in non-cognitive outcomes. Non-pharmacotherapy such as music therapy is potentially associated with improved outcomes. We assessed the effects of music therapy on patients with dementia to evaluate its potential benefits on dementia. Two independent reviewers searched MEDLINE, EMBASE, CINAHL, CENTRAL, and ClinicalTrials.gov databases for clinical trials, using the keywords “music therapy” and “dementia”. Study outcomes included cognitive function, behavioral and psychological symptoms of dementia (BPSD), and quality of life. A total of 82 studies were included, of which 43 were interventional clinical trials, and 39 were systematic reviews or meta-analyses. Significant improvements in verbal fluency occurred after music therapy, with significant reductions in anxiety, depression, and apathy. There were no significant improvements in cognition or daily functioning, and the results on quality of life and agitation were ambiguous. Limitations of studies included low patient numbers, lack of standardized music therapy, and high heterogeneity in outcomes. More large-scale clinical trials would allow for clearer conclusions on the benefits of music therapy in patients with dementia.

Determining the safety and effectiveness of Tai Chi: A critical overview of 210 systematic reviews of controlled clinical trials

2021 ◽  
Author(s):  
Guo-Yan Yang ◽  
Jennifer Hunter ◽  
Fan-Long Bu ◽  
Wen-Li Hao ◽  
Han Zhang ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Tai Chi ◽  
Controlled Clinical Trials ◽  
Language Bias ◽  
Important Benefit ◽  
Statistical Heterogeneity ◽  
Wide Range ◽  
Randomised Controlled ◽  
Meta Analyses

Abstract Background: This overview aims to critically appraise the best available systematic review (SR) evidence on the health effects of Tai Chi. Methods: Nine databases (English and Chinese languages) were searched for SRs of controlled clinical trials of Tai Chi interventions published between Jan-2010 and Dec-2020 in any language. Excluded were primary studies and meta-analyses that combined Tai Chi with other interventions. To minimise overlap, effect estimates were extracted from the most recent, comprehensive, highest quality SR for each population, condition, and outcome. SR quality was appraised using AMSTAR 2 and effect estimates with GRADE.Results: Of the 210 included SRs, 193 only included randomised controlled trials, one only included non-randomised studies of interventions, and 16 included both. The most common conditions were neurological (18.6%), falls/balance (14.7%), cardiovascular (14.7%), musculoskeletal (11.0%), cancer (7.1%) and diabetes mellitus (6.7%). Except for stroke, no evidence for disease prevention was found, instead proxy-outcomes/risks factors were evaluated. 114 effect estimates were extracted from 37 SRs (2 high quality, 6 moderate, 18 low, and 11 critically low), representing 59,306 adults. Compared to active and/or inactive controls, a clinically important benefit from Tai Chi was reported for 66 effect estimates; 53 reported an equivalent or marginal benefit, and 6 an equivalent risk of adverse events. Eight effect estimates (7.0%) were graded as high certainty evidence, 43 (37.7%) moderate, 36 (31.6%) low, and 27 (23.7%) very low. This was due to concerns with risk of bias in 92 (80.7%) effect estimates, imprecision in 43 (37.7%), inconsistency in 37 (32.5%) and publication bias in 3 (2.6%). SR quality was limited by the search strategies, language bias, inadequate consideration of clinical, methodological and statistical heterogeneity, poor reporting standards, and/or no registered protocol. Conclusions: The findings suggest Tai Chi has multisystem effects with physical, psychological, and quality of life benefits for a wide range of conditions, including individuals with multiple health problems. Clinically important benefits were most consistently reported for Parkinson’s disease, falls risk, knee osteoarthritis, low back pain, cardiovascular diseases including hypertension, and stroke. Notwithstanding, for most conditions, higher quality primary studies and SRs are required.

scholarly journals The effects of exercise and low-calorie diets compared with low-calorie diets alone on health: a protocol for systematic reviews and meta-analyses of controlled clinical trials

2020 ◽  
Author(s):  
Sara Beigrezaei ◽  
Zeinab Yazdanpanah ◽  
Sepideh Soltani ◽  
Seiedeh Hamideh Rajaei ◽  
Sahar Mohseni-Takalloo ◽  
...  
Keyword(s):  
Systematic Review ◽  
Weight Loss ◽  
Clinical Trials ◽  
Meta Analysis ◽  
Controlled Clinical Trials ◽  
Low Calorie ◽  
Low Calorie Diet ◽  
Calorie Diet ◽  
Meta Analyses

Abstract Background: Exercise and weight loss diets are two independent non-pharmaceutical strategies known to improve several aspects of body composition and health. We plan to systematically review randomized controlled trials investigating weight loss diets alone compared to weight loss diets in conjunction with exercise on energy intake, body weight, body composition, cardiometabolic risk factors, sex hormones, and mental health. Methods and analysis: PubMed/MEDLINE, EMBASE, ISI (Web of sciences), Scopus, and Google Scholar will be searched to retrieve potential controlled clinical trials investigating the effects of exercise in conjunction with weight-loss diets compared with weight-loss diets alone on energy intake, body weight and composition (fat mass, fat-free mass), anthropometrics (waist circumference), cardiometabolic markers, sex hormones [testosterone, estradiol, and sex hormone binding globulin (SHBG)], liver and kidney enzymes (alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma-glutamyl transferase (GGT), uric acid, blood urea nitrogen (BUN), and glomerular filtration rate (GFR), quality of life, and depression in adults will be included. The weighted mean difference (WMD) and its corresponding 95% confidence intervals (CIs) will be derived using the random effects model. Several subgroup analyses such as gender, age, BMI, exercise protocol, and diet used for weight loss will be conducted to explore possible sources of heterogeneity. Publication bias will be explored by inspecting funnel plots and by conducting asymmetry tests. Overall quality of the evidence will be assessed by using the NutriGrade scoring system, which is designed to judge the overall quality of meta-analyses of clinical trials conducted in the field of nutrition. Discussion: This proposed systematic review and meta-analysis aims to compare the effects of a low-calorie diet with low-calorie diet plus exercise on the risk factors for chronic diseases. We hope this systematic review and meta-analysis will provide valuable information regarding the values which exercise add to weight-loss diets. No primary data are going to be collected; therefore, ethical approval is not required. The resulting manuscripts will be disseminated in peer-reviewed journals and at international and local conferences. Systematic review registration: This protocol in being considered for registration in the International Prospective Register of Systematic Reviews (PROSPERO).

scholarly journals Therapeutic effects of exercise interventions for patients with chronic kidney disease: protocol for an overview of systematic reviews and meta-analyses of clinical trials

BMJ Open ◽  
2021 ◽  
Vol 11 (2) ◽  
pp. e043011
Author(s):  
Fan Zhang ◽  
Hui Wang ◽  
Liuyan Huang ◽  
Huachun Zhang
Keyword(s):  
Chronic Kidney Disease ◽  
Clinical Trials ◽  
Kidney Disease ◽  
Systematic Reviews ◽  
Therapeutic Effects ◽  
Exercise Interventions ◽  
Central Registry ◽  
Overview Of Systematic Reviews ◽  
Meta Analyses

IntroductionAn increasing number of systematic reviews and meta-analyses of clinical trials have begun to investigate the effects of exercise interventions in patients with chronic kidney disease (CKD). To systematically appraise and synthesise these results, we will conduct an overview of systematic reviews and meta-analyses.Methods and analysisThis is a protocol for an overview of systematic reviews and meta-analyses. We will search four databases: PubMed, Embase, Web of Science Core Collection and Cochrane Central Registry of Controlled Trials. Systematic reviews and meta-analyses of clinical trials evaluating the effect of exercise interventions on patients with CKD will be included. Two independent authors will screen titles and abstracts retrieved in the literature search and select studies meeting the eligibility criteria for full-text review. The methodological quality of the included reviews will be assessed using A Measurement Tool to Assess Systematic Reviews-2. We estimate the summary effects for each meta-analyses based on the standardised mean difference and its 95% CI. Additionally, the heterogeneity will be assessed by I2 evidence of small-study effect and the quality of evidence using the Grading of Recommendations Assessment, Development and Evaluation system.Ethics and disseminationEthics approval are not required as no private information from individuals is collected. The results will be published in a peer-reviewed journal or disseminated in relevant conferences.PROSPERO registration numberCRD42020223591.

scholarly journals Wellness Review 2021, Part 1

2021 ◽  
Vol 3 (2) ◽  
Author(s):  
Martin Huecker ◽  
◽  
Jacob Shreffler ◽  
Keyword(s):  
Clinical Trials ◽  
Healthcare Professional ◽  
Medical Profession ◽  
Educational Interventions ◽  
Review Literature ◽  
System Level ◽  
Medical Specialties ◽  
Healthcare Executives ◽  
Meta Analyses

Introduction: This article presents a curated selection of the wellness literature from January to June of 2021. JWellness editors offer a summary of recent publications within the wellness domain to seek an understanding of both burnout prevention and, more importantly, thriving in the medical profession. Methods: For the interval of Jan 1 to June 30, 2021, a UofL librarian queried PubMed for empirical research studies, review articles, and editorials related to healthcare professional wellness. Excluding papers related to COVID-19 (due to extensive prior coverage) and editorials/commentaries, the editors narrowed to 43 articles (systematic reviews, meta-analyses, general reviews, and clinical trials) for this review. Literature in Review: Six chief themes emerged: general wellness / burnout, technology, training, nursing professional wellness, mindfulness and resilience, and physician specialty-specific considerations. We note the predominance of descriptive articles, though this round included more clinical trials and reviews of clinical trials. Overall quality of evidence remains low, however the conglomerate multinational dataset is expanding rapidly. Innovations in electronic documentation, early educational interventions, and diverse studies from various medical specialties converge to provide insight into a state of thriving among healthcare professionals. Conclusion: Current literature into healthcare professional wellness continues to describe burnout, but increasingly includes dedicated wellness interventions. Resilience and mindfulness training work, but system level interventions must accompany efforts. All medical specialties are affected, and the continuing conversation should include healthcare executives and other leadership.

Psychological and Cognitive Aspects of Borderline Intellectual Functioning

2017 ◽  
Vol 22 (3) ◽  
pp. 159-166 ◽  
Author(s):  
Bastianina Contena ◽  
Stefano Taddei
Keyword(s):  
Quality Of Life ◽  
Systematic Review ◽  
Intellectual Functioning ◽  
Clinical Impact ◽  
Review Of The Literature ◽  
Borderline Intellectual Functioning ◽  
General Quality ◽  
Meta Analyses ◽  
Over Time

Abstract. Borderline Intellectual Functioning (BIF) refers to a global IQ ranging from 71 to 84, and it represents a condition of clinical attention for its association with other disorders and its influence on the outcomes of treatments and, in general, quality of life and adaptation. Furthermore, its definition has changed over time causing a relevant clinical impact. For this reason, a systematic review of the literature on this topic can promote an understanding of what has been studied, and can differentiate what is currently attributable to BIF from that which cannot be associated with this kind of intellectual functioning. Using Preferred Reporting Items for Systematic Review and Meta-Analyses (PRISMA) criteria, we have conducted a review of the literature about BIF. The results suggest that this condition is still associated with mental retardation, and only a few studies have focused specifically on this condition.

Rationale for heparin treatment of colon cancer

2000 ◽  
Vol 20 (03) ◽  
pp. 136-142 ◽  
Author(s):  
D. L. Ornstein ◽  
L. R. Zacharski
Keyword(s):  
Clinical Trials ◽  
Substantial Improvement ◽  
Patients With Cancer ◽  
Coagulation Mechanism ◽  
Anticoagulant Drug ◽  
Cancer Outcome ◽  
Meta Analyses ◽  
Improvement In Survival ◽  
Spectrum Of Patients ◽  
To Receive

SummaryIt is widely known that the systemic blood coagulation mechanism is often activated in malignancy, leading to an increased incidence of vascular thromboses in patients with cancer. It is not widely appreciated, however, that products of the coagulation mechanism may also support tumor growth and dissemination. Interest in this approach to cancer therapy has surged recently because of mounting evidence that the familiar anticoagulant drug, heparin, may impede tumor progression. Heparin has the capacity to modify angiogenesis, growth factor and protease activity, immune function, cell proliferation and gene expression in ways that may block malignant dissemination. Clinical trials in which heparin has been administered to a broad spectrum of patients to prevent or treat thrombosis have unexpectedly shown improvement in survival in the subset of patients with malignancy entered to these studies. Meta-analyses of clinical trials comparing unfractionated (UF) versus low molecular weight (LMW) heparin treating venous thromboembolism suggest that there may be substantial improvement in cancer outcome in patients with malignancy randomized to receive LMW heparin. These findings provide a rationale for definitive clinical trials of LMW heparin in cancer, and the results of several such studies that are currently underway are awaited with interest.

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