Is there a role for real life observational studies in integrating knowledge provided by randomized clinical trials?

2006 ◽  
Vol 18 (4) ◽  
pp. 274-276
Author(s):  
S. Maggi ◽  
E. Scafato
Keyword(s):  
Clinical Trials ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Real Life

scholarly journals Approaches to Assessing the Quality of Observational Studies of Clinical Practice Based on the Big Data Analysis

2021 ◽  
Vol 17 (4) ◽  
pp. 584-593
Author(s):  
S. R. Gilyarevsky
Keyword(s):  
Clinical Trials ◽  
Big Data ◽  
Clinical Practice ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Real Life ◽  
Hierarchy Of Evidence

The article is devoted to the discussion of the problems of assessing the quality of observational studies in real clinical practice and determining their place in the hierarchy of evidence-based information. The concept of “big data” and the acceptability of using such a term to refer to large observational studies is being discussed. Data on the limitations of administrative and claims databases when performing observational studies to assess the effects of interventions are presented. The concept of confounding factors influencing the results of observational studies is discussed. Modern approaches to reducing the severity of bias in real-life clinical practice studies are presented. The criteria for assessing the quality of observational pharmacoepidemiological studies and the fundamental differences between such studies and randomized clinical trials are presented. The results of systematic reviews of real-life clinical trials to assess the effects of direct oral anticoagulants are discussed. 

Can We Trust Observational Studies Using Propensity Scores in the Critical Care Literature? A Systematic Comparison With Randomized Clinical Trials*

2015 ◽  
Vol 43 (9) ◽  
pp. 1870-1879 ◽  
Author(s):  
Georgios D. Kitsios ◽  
Issa J. Dahabreh ◽  
Sean Callahan ◽  
Jessica K. Paulus ◽  
Anthony C. Campagna ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Critical Care ◽  
Observational Studies ◽  
Propensity Scores ◽  
Randomized Clinical Trials ◽  
Systematic Comparison

scholarly journals Statins in Heart Failure: The Paradox Between Large Randomized Clinical Trials and Real Life

2012 ◽  
Vol 87 (6) ◽  
pp. 555-560 ◽  
Author(s):  
Paloma Gastelurrutia ◽  
Josep Lupón ◽  
Marta de Antonio ◽  
Agustin Urrutia ◽  
Crisanto Díez ◽  
...  
Keyword(s):  
Heart Failure ◽  
Clinical Trials ◽  
Randomized Clinical Trials ◽  
Real Life

scholarly journals Guidelines on how to assess the validity of results presented in subgroup analysis of clinical trials

2002 ◽  
Vol 57 (2) ◽  
pp. 83-88 ◽  
Author(s):  
Edson Duarte Moreira ◽  
Ezra Susser
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Randomized Clinical Trial ◽  
Subgroup Analysis ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Usual Method ◽  
Validity Of Results ◽  
Results Of Treatment ◽  
Trial Participants

In observational studies, identification of associations within particular subgroups is the usual method of investigation. As an exploratory method, it is the bread and butter of epidemiological research. Nearly everything that has been learned in epidemiology has been derived from the analysis of subgroups. In a randomized clinical trial, the entire purpose is the comparison of the test subjects and the controls, and when there is particular interest in the results of treatment in a certain section of trial participants, a subgroup analysis is performed. These subgroups are examined to see if they are liable to a greater benefit or risk from treatment. Thus, analyzing patient subsets is a natural part of the process of improving therapeutic knowledge through clinical trials. Nevertheless, the reliability of subgroup analysis can often be poor because of problems of multiplicity and limitations in the numbers of patients studied. The naive interpretation of the results of such examinations is a cause of great confusion in the therapeutic literature. We emphasize the need for readers to be aware that inferences based on comparisons between subgroups in randomized clinical trials should be approached more cautiously than those based on the main comparison. That is, subgroup analysis results derived from a sound clinical trial are not necessarily valid; one must not jump to conclusions and accept the validity of subgroup analysis results without an appropriate judgment.

scholarly journals Sex-Gender Variable: Methodological Recommendations for Increasing Scientific Value of Clinical Studies

Cells ◽  
2019 ◽  
Vol 8 (5) ◽  
pp. 476 ◽  
Author(s):  
Flavia Franconi ◽  
Ilaria Campesi ◽  
Delia Colombo ◽  
Paola Antonini
Keyword(s):  
Clinical Trials ◽  
Environmental Factors ◽  
Gender Gap ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
Sex And Gender ◽  
Key Factors ◽  
And Gender ◽  
Scientific Value ◽  
Racial Ethnic

There is a clear sex–gender gap in the prevention and occurrence of diseases, and in the outcomes and treatments, which is relevant to women in the majority of cases. Attitudes concerning the enrollment of women in randomized clinical trials have changed over recent years. Despite this change, a gap still exists. This gap is linked to biological factors (sex) and psycho-social, cultural, and environmental factors (gender). These multidimensional, entangled, and interactive factors may influence the pharmacological response. Despite the fact that regulatory authorities recognize the importance of sex and gender, there is a paucity of research focusing on the racial/ethnic, socio-economic, psycho-social, and environmental factors that perpetuate disparities. Research and clinical practice must incorporate all of these factors to arrive at an intersectional and system-scenario perspective. We advocate for scientifically rigorous evaluations of the interplay between sex and gender as key factors in performing clinical trials, which are more adherent to real-life. This review proposes a set of 12 rules to improve clinical research for integrating sex–gender into clinical trials.

scholarly journals Associations of Plant-Based Foods and Diets with Gestational Diabetes: A Systematic Review of Observational Studies and Clinical Trials

2020 ◽  
Vol 4 (Supplement_2) ◽  
pp. 948-948
Author(s):  
Tristesse Burton ◽  
James Alexander ◽  
Petar Planinic ◽  
Arpita Basu
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Gestational Diabetes ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Chinese Herb ◽  
Nutrition Therapy ◽  
Cross Sectional ◽  
Evening Primrose ◽  
Funding Sources

Abstract Objectives Gestational diabetes mellitus (GDM) is one of the most common health complications during pregnancy. Medical nutrition therapy is the mainstay of treatment for GDM, however, there is no current consensus on the optimal dietary approaches for prevention and management of hyperglycemia during pregnancy. Our objective is to assess the relationship of plant-based diets, foods, and dietary supplements with GDM and maternal glycemic biomarkers in observational and clinical studies. Methods A systematic review was performed using PubMed to identify original articles from 1999–2019 following the PRISMA checklist statement. Articles were excluded if they were review articles, conference abstracts, not in English or did not meet the pre-defined PICOS (Population, Intervention/exposure, Comparison, Outcome, Study design) criteria. Articles were screened for relevance, extracted and summarized, and assessed for risk of bias and quality. Results A total of 431 articles were screened, 33 observational studies (prospective cohort: n = 26, case-control: n = 3, cross-sectional: n = 4) involving 147,576 women and 11 randomized clinical trials involving 3940 women were included. Among the observational studies, Mediterranean diet (MedDiet), fiber, and vegetable rich diets were associated with a significant decrease in GDM risk. Among the clinical trials, Dietary Approaches to Stop Hypertension (DASH) diet, MedDiet, soy, phytosterol spread, evening primrose, chili powder and a traditional Chinese herb, Artemisia scoparia Waldst. & Kit. (Asteraceae) (n = 1) exhibited improved maternal hyperglycemia, insulin resistance or sensitivity, and hypoadiponectinemia. Conclusions These findings suggest that plant-based diets may be effective in preventing and managing hyperglycemia during pregnancy. Particularly, adherence to a MedDiet may improve maternal glycemic biomarker and decrease risk of GDM. Funding Sources UNLV Faculty research start up award.

Measuring clinical practice: science and methods

2013 ◽  
Vol 34 (1) ◽  
pp. E3 ◽  
Author(s):  
Peter D. Angevine ◽  
Paul C. McCormick
Keyword(s):  
Clinical Trials ◽  
Clinical Data ◽  
Observational Studies ◽  
Randomized Clinical Trials ◽  
Treatment Options ◽  
Routine Practice ◽  
Clinical Settings ◽  
Clinical Registries ◽  
Basic Understanding

The routine practice of neurosurgery generates a large amount of clinical data. The structured, systematic capture of this information using clinical registries or other rigorously designed observational studies can yield useful evidence to help improve the care of patients. Registries in particular can be designed to measure outcomes in real-world clinical settings and to study differences in outcomes between subgroups. This information can help clinicians to advise patients regarding their treatment options. To provide valid, generalizable evidence, however, registries and other observational studies must be designed and conducted with a rigor similar to that of randomized clinical trials. Neurosurgeons with a basic understanding of the potential advantages and pitfalls of nonrandomized trials and the methods of statistical analysis will be able to assess the quality of clinical data and to incorporate the findings appropriately into their patients' care.

scholarly journals Pregnancy Rates with Recombinant versus Urinary Human Chorionic Gonadotropin in In Vitro Fertilization: An Observational Study

2011 ◽  
Vol 11 ◽  
pp. 1781-1787 ◽  
Author(s):  
József Zeke ◽  
Katalin Kanyó ◽  
Helga Zeke ◽  
Áron Cseh ◽  
Barna Vásárhelyi ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Chorionic Gonadotropin ◽  
Human Chorionic Gonadotropin ◽  
Clinical Characteristics ◽  
Randomized Clinical Trials ◽  
Real Life ◽  
In Vitro Fertilisation ◽  
Vitro Fertilization ◽  
Equal Efficacy

Randomized clinical trials (RCTs) demonstrated the equal efficacy of urinary human chorionic gonadotropin (uhCG) and recombinant hCG (rhCG) products in in vitro fertilisation (IVF). However, limitations inherent with RCTs necessitate the reinforcement of RCT results in real-life. We retrospectively analyzed pregnancies after treatment with rhCG and uhCG products (n=391, and 96, resp.). We found that laboratory-verified pregnancy occurred more frequently in rhCG patients than in those on uhCG (43% versus 30%,P=0.02). The association remains significant (P=0.002) after its adjustment for clinical characteristics. The prevalence of laboratory-verified pregnancies was higher with GnRH agonist use (P=0.012) and BMI under 30 kg/m2(P=0.053) while decreased the age (P=0.014) and the number of previous failed attempts (P=0.08). Similar (but not significant) trends were observed with rates of pregnancy filled the 24th week. These results reinforce RCTs supporting the notion that rhCG is more efficient as uhCG during IVF.

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