The relationship between study design, results, and reporting of randomized clinical trials of HIV infection

1997 ◽  
Vol 18 (5) ◽  
pp. 431-444 ◽  
Author(s):  
John P.A. Ioannidis ◽  
Joseph C. Cappelleri ◽  
Henry S. Sacks ◽  
Joseph Lau
Keyword(s):  
Clinical Trials ◽  
Hiv Infection ◽  
Study Design ◽  
Randomized Clinical Trials ◽  
The Relationship

Correlation between patient-reported fatigue and hemoglobin (Hgb) levels in metastatic renal cell carcinoma (mRCC) patients (pts) receiving sunitinib (SU).

2014 ◽  
Vol 32 (4_suppl) ◽  
pp. 418-418
Author(s):  
Mellar P. Davis ◽  
Ewa M. Matczak ◽  
Connie Chen ◽  
Beata Korytowsky ◽  
Helen Bhattacharyya ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Renal Cell Carcinoma ◽  
Clinical Trials ◽  
Cell Carcinoma ◽  
Renal Cell ◽  
Randomized Clinical Trials ◽  
Dosing Schedule ◽  
Patient Reported ◽  
The Relationship

418 Background: Low Hgb is linked with fatigue in cancer pts; however, the onset and severity of fatigue is multifactorial. The approved SU dosing schedule in mRCC is 4 weeks on treatment, 2 weeks off, and quality of life (QoL) when examined on day 28 is significantly worse than on day 1 of each cycle. The relationship between pt-reported fatigue and Hgb levels with SU in mRCC was investigated. Methods: Two randomized clinical trials of SU were combined to examine the pt-reported fatigue item from FKSI-15 which asks pts to indicate their level of fatigue on a 5-point Likert scale from 0=“not at all” to 4=“very much”. Data were collected at baseline (BL; cycle 1, day 1) and on days 28 and 42 of each 42-day cycle. For each visit, only pts who had data for both fatigue and Hgb at BL were included in the analysis. Results: 481 pts were included. Fatigue and Hgb levels at BL and over cycles 1–6 are shown in the table. Pts reported worse fatigue (higher score) at day 28 of each cycle than on day 42. Fatigue scores typically ranged from 1= “a little bit” to 2=“somewhat”. Changes in Hgb levels, however, were modest and opposite to fatigue changes i.e. were higher on day 28 of each cycle and lower on day 42. Findings were similar beyond cycle 6. Conclusions: Pts indicated less fatigue on day 42, after the 2-week break, than on day 28 of each cycle, consistent with previous overall QoL findings. Low Hgb is not associated with worse fatigue in mRCC pts receiving SU.This may be due to the multifactorial nature of fatigue. The ‘on’ and ‘off’ periods in intermittent dosing are important considerations of patients’ full experience of QoL. [Table: see text]

Study Design for Vitamin D Randomized Clinical Trials—Reply

2015 ◽  
Vol 175 (10) ◽  
pp. 1720
Author(s):  
Kirsti Uusi-Rasi ◽  
Radhika Patil ◽  
Kari Tokola
Keyword(s):  
Vitamin D ◽  
Clinical Trials ◽  
Study Design ◽  
Randomized Clinical Trials

scholarly journals Maintaining Integrity of Worldwide FINGER Clinical Trials During the COVID-19 Pandemic

2021 ◽  
Vol 5 (Supplement_1) ◽  
pp. 68-68
Author(s):  
Susanne Roehr
Keyword(s):  
Clinical Trials ◽  
Study Design ◽  
World Wide ◽  
Randomized Clinical Trials ◽  
Statistical Design ◽  
Sensitivity Analyses ◽  
Intervention Delivery ◽  
Intention To Treat ◽  
Approaches To Study ◽  
Intervention Trials

Abstract The COVID-19 pandemic presents challenges to the conduct of randomized clinical trials of lifestyle interventions. World-Wide FINGERS international network convened a forum for researchers to discuss statistical design and analysis issues they faced during the pandemic. We report experiences of three trials that, at various stages of conduct, altered designs and analysis plans to navigate these issues. We provide recommendations for future trials to consider as they develop and launch behavioral intervention trials. The pandemic led researchers to change recruitment plans, interrupt timelines for assessments and intervention delivery, and move to remote intervention and assessments protocols. The necessity of these changes add emphasis to the importance, in study design and analysis, of intention to treat approaches, flexibility, within site stratification, interim power projections, and sensitivity analyses. Robust approaches to study design and analysis are critical to negotiate issues related to the intervention.

Study Design for Vitamin D Randomized Clinical Trials

2015 ◽  
Vol 175 (10) ◽  
pp. 1720
Author(s):  
Richard L. Prince ◽  
Joshua Lewis ◽  
Peter R. Ebeling
Keyword(s):  
Vitamin D ◽  
Clinical Trials ◽  
Study Design ◽  
Randomized Clinical Trials

scholarly journals Contrast Media: Are There Differences in Nephrotoxicity among Contrast Media?

2014 ◽  
Vol 2014 ◽  
pp. 1-8 ◽  
Author(s):  
Richard Solomon
Keyword(s):  
Clinical Trials ◽  
Contrast Media ◽  
Contrast Agents ◽  
Filtration Rate ◽  
Randomized Clinical Trials ◽  
The Past ◽  
Iodinated Contrast ◽  
Using Data ◽  
The Relationship ◽  
Iodinated Contrast Agents

Iodinated contrast agents are usually classified based upon their osmolality—high, low, and isosmolar. Iodinated contrast agents are also nephrotoxic in some but not all patients resulting in loss of glomerular filtration rate. Over the past 30 years, nephrotoxicity has been linked to osmolality although the precise mechanism underlying such a link has been elusive. Improvements in our understanding of the pathogenesis of nephrotoxicity and prospective randomized clinical trials have attempted to further explore the relationship between osmolality and nephrotoxicity. In this review, the basis for our current understanding that there are little if any differences in nephrotoxic potential between low and isosmolar contrast media will be detailed using data from clinical studies.

scholarly journals Vitamin D and Gestational Diabetes Mellitus: Is There a Link?

Antioxidants ◽  
2019 ◽  
Vol 8 (11) ◽  
pp. 511 ◽  
Author(s):  
Gianluca Rizzo ◽  
Simone Garzon ◽  
Michele Fichera ◽  
Marco Marzio Panella ◽  
Ursula Catena ◽  
...  
Keyword(s):  
Diabetes Mellitus ◽  
Vitamin D ◽  
Clinical Trials ◽  
Gestational Diabetes ◽  
Gestational Diabetes Mellitus ◽  
Randomized Clinical Trials ◽  
Outcome Measurement ◽  
Current Evidence ◽  
Vitamin D Levels ◽  
The Relationship

Gestational diabetes mellitus (GDM) is a very common condition among pregnant women worldwide with important metabolic implications on the mother and the offspring. Vitamin D status has been suggested to potentially play a role in GDM risk with no documented consequences for the offspring. The purpose of this article was to review currently available evidence on the relationship between vitamin D and GDM. Current evidence shows an association between vitamin D blood levels and risk of GDM, despite heterogeneity of results across studies limit the conclusions. Moreover, data from randomized controlled trials is scarce and resulting in null findings. Among the limitations to be noted, improving the standardization of dosages, the characteristics of individuals in the sample, and the appropriate outcome measurement could provide a more effective approach in understanding the relationship between vitamin D and GDM. In conclusions, despite observational studies may suggest that adequate vitamin D levels may decrease the risk of GDM compared to deficiency status, evidence from clinical trials is inadequate to draft any definitive conclusion regarding its supplementation. Future better designed randomized clinical trials taking into account a more integrated approach could provide clearer and definitive data on the outcomes of such a multifactorial condition.

Effects of hesperidin consumption on cardiovascular risk biomarkers: a systematic review of animal studies and human randomized clinical trials

2019 ◽  
Vol 77 (12) ◽  
pp. 845-864 ◽  
Author(s):  
L Pla-Pagà ◽  
J Companys ◽  
L Calderón-Pérez ◽  
E Llauradó ◽  
R Solà ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Cardiovascular Risk ◽  
Study Design ◽  
Animal Studies ◽  
Randomized Clinical Trials ◽  
Research Question ◽  
Current Evidence ◽  
Inclusion Criteria ◽  
Risk Biomarkers

Abstract Context The cardioprotective effects of the flavonoid hesperidin, which is present in citrus products, are controversial and unclear. This systematic review was conducted in accordance with the PRISMA 2015 guidelines. Objective To evaluate the current evidence from animal and human clinical studies and thus determine whether the consumption of hesperidin exerts beneficial effects on cardiovascular risk factors. Data sources PICOS (Population, Intervention, Comparison, Outcome, and Study Design) criteria defined the research question. Searches of the PubMed and Cochrane Plus databases were conducted and studies that met the inclusion criteria and were published in English in the last 15 years were included. Data extraction The first author, year of publication, study design, characteristics of animals and humans, intervention groups, dose of hesperidin, route of administration, duration of the intervention, cardiovascular risk biomarkers assessed, and results observed were extracted from the included articles. Results A total of 12 animal studies and 11 randomized clinical trials met the inclusion criteria. In the animal studies, the glucose, total and LDL cholesterol, and triglyceride levels decreased with chronic flavonoid consumption. In the human studies, endothelial function improved with flavonoid consumption, whereas no conclusive results were observed for the other biomarkers. Conclusions Animal studies have revealed that hesperidin and hesperetin consumption reduces glucose levels and various lipid profile parameters. However, a definitive conclusion cannot be drawn from the existing human clinical trials. Further research is needed to confirm whether the findings observed in animal models can also be observed in humans. Systematic Review Registration Prospero registration number CRD42018088942.

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