Health Outcomes Data Gathering in Clinical Trials: Economic and Humanistic Assessments

2001 ◽  
Vol 35 (1) ◽  
pp. 173-179 ◽  
Author(s):  
Josephine M. Wong ◽  
Shilpa S. Mehta
Keyword(s):  
Clinical Trials ◽  
Health Outcomes ◽  
Data Gathering

Minimal Modeling Approaches to Value of Information Analysis for Health Research

2011 ◽  
Vol 31 (6) ◽  
pp. 785-786 ◽  
Author(s):  
David O. Meltzer ◽  
Ties Hoomans ◽  
Jeannette W. Chung ◽  
Anirban Basu
Keyword(s):  
Clinical Trials ◽  
Health Outcomes ◽  
Clinical Research ◽  
Value Of Information ◽  
Clinical Applications ◽  
Information Analysis ◽  
Practical Applications ◽  
Modeling Approaches ◽  
Expected Benefits ◽  
Analytic Models

Value of information (VOI) techniques can provide estimates of the expected benefits from clinical research studies that can inform decisions about the design and priority of those studies. Most VOI studies use decision-analytic models to characterize the uncertainty of the effects of interventions on health outcomes, but the complexity of constructing such models can pose barriers to some practical applications of VOI. However, because some clinical studies can directly characterize uncertainty in health outcomes, it may sometimes be possible to perform VOI analysis with only minimal modeling. This article 1) develops a framework to define and classify minimal modeling approaches to VOI, 2) reviews existing VOI studies that apply minimal modeling approaches, and 3) illustrates and discusses the application of the minimal modeling to two new clinical applications to which the approach appears well suited because clinical trials with comprehensive outcomes provide preliminary estimates of the uncertainty in outcomes. We conclude that minimal modeling approaches to VOI can be readily applied to in some instances to estimate the expected benefits of clinical research.

scholarly journals A Systematic Review of Organic Versus Conventional Food Consumption: Is There a Measurable Benefit on Human Health?

Nutrients ◽  
2019 ◽  
Vol 12 (1) ◽  
pp. 7 ◽  
Author(s):  
Vigar ◽  
Myers ◽  
Oliver ◽  
Arellano ◽  
Robinson ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Health Outcomes ◽  
Human Health ◽  
Food Consumption ◽  
Health Benefits ◽  
Organic Food ◽  
Observational Research ◽  
Current Evidence ◽  
Current Evidence Base ◽  
Organic Food Consumption

The current review aims to systematically assess the evidence related to human health outcomes when an organic diet is consumed in comparison to its conventional counterpart. Relevant databases were searched for articles published to January 2019. Clinical trials and observational research studies were included where they provided comparative results on direct or indirect health outcomes. Thirty-five papers met the criteria for inclusion in the review. Few clinical trials assessed direct improvements in health outcomes associated with organic food consumption; most assessed either differences in pesticide exposure or other indirect measures. Significant positive outcomes were seen in longitudinal studies where increased organic intake was associated with reduced incidence of infertility, birth defects, allergic sensitisation, otitis media, pre-eclampsia, metabolic syndrome, high BMI, and non-Hodgkin lymphoma. The current evidence base does not allow a definitive statement on the health benefits of organic dietary intake. However, a growing number of important findings are being reported from observational research linking demonstrable health benefits with organic food consumption. Future clinical research should focus on using long-term whole-diet substitution with certified organic interventions as this approach is more likely to determine whether or not true measurable health benefits exist.

Brief report of virtual clinician research tools for tobacco dependence or dyslipidemia

2016 ◽  
Vol 22 (11) ◽  
pp. 1463-1468 ◽  
Author(s):  
Geoffrey C Williams ◽  
Lisa Lowenstein ◽  
John F Cox ◽  
Heather Patrick ◽  
Michael Jacob Adams ◽  
...  
Keyword(s):  
Health Care ◽  
Clinical Trials ◽  
Health Outcomes ◽  
Autonomy Support ◽  
Low Density Lipoprotein ◽  
Density Lipoprotein ◽  
Tobacco Dependence ◽  
Low Density ◽  
The Mean ◽  
Cholesterol Management

Health avatars were created to deliver previously tested live interventions for tobacco dependence and cholesterol management. The exploratory aims were to develop and test whether the avatar can be reliably assessed for autonomy supportiveness using the Health Care Climate Questionnaire and estimate the mean changes in motivation variables and correlate the avatars’ autonomy supportiveness with the motivation variables and health outcomes. The avatars were found to be reliably assessed for autonomy supportiveness on the Health Care Climate Questionnaire. Autonomy support was positively correlated with the change in motivations and reduction in low-density lipoprotein. These findings suggest that health avatars may be tested in clinical trials.

scholarly journals Association between vaping and health outcomes in patients with opioid use disorder: a systematic review protocol

BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040349
Author(s):  
Nitika Sanger ◽  
Alessia D'Elia ◽  
Stephanie Sanger ◽  
Tea Rosic ◽  
M Constantine Samaan ◽  
...  
Keyword(s):  
Systematic Review ◽  
Clinical Trials ◽  
Health Outcomes ◽  
Addiction Treatment ◽  
Data Extraction ◽  
Opioid Use Disorder ◽  
Cochrane Library ◽  
Opioid Use ◽  
Polysubstance Use ◽  
Clinical Trials Registry

IntroductionVaping behaviour has increased in popularity and is particularly important to examine how it effects health outcomes in vulnerable populations, including those with opioid use disorder (OUD). With polysubstance use including cigarette and cannabis use being highly prevalent in the OUD population and cannabis/nicotine increasingly being consumed by vaping, vaping may have an important contribution to health outcomes in these individuals. The primary objective of this review is to systematically assess the literature related to patients with OUD and the effects vaping has shown on their physical and mental health.Method and analysisA systematic search of databases including MEDLINE, Embase, PsycINFO, Web of Science, Cumulative Index to Nursing and Allied Health Literature, Cochrane Library, Cochrane Clinical Trials Registry, the National Institutes for Health Clinical Trials Registry and the WHO International Clinical Trials Registry Platform from inception to 31 December 2020 will be conducted. Identified citations will be screened by two reviewers to determine eligibility at the title and abstract level, and then at the full text and data extraction phases. Any disagreements in inclusion will be resolved through unblinded discussion by these reviewers, with any remaining disagreements being resolved by a third reviewer. Data collection from eligible studies will be conducted according to the data extraction form tested prior to abstraction. Included studies will be examined for quality and bias and will be meta-analysed where applicable. This protocol is reported in keeping with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines.Ethics and disseminationThe results for this review will be disseminated through publications in peer-reviewed journals, posters and presentations at scientific conferences. Additionally, we are collaborating with the Canadian Addiction Treatment Centre clinics to help disseminate the findings for this review. As this is a systematic review, no ethics approval is needed.Review registration numberCRD42020178441.

scholarly journals Registry-based randomized clinical trials’ indications, methods, health outcomes and reporting: A scoping review protocol

2021 ◽  
Author(s):  
Will Douglas ◽  
Adrian Sammy ◽  
Katherine Goren ◽  
Ami Baba ◽  
Brett Thombs ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Health Outcomes ◽  
Scoping Review ◽  
Randomized Clinical Trials ◽  
Future Design ◽  
The Future ◽  
Review Protocol

This scoping review aims to identify and synthesize recent RRCTs and protocols to help inform the future design, conduct, and reporting of RRCTs.

scholarly journals Best Practices for Conducting Clinical Trials With Indigenous Children in the United States

2021 ◽  
Vol 111 (9) ◽  
pp. 1645-1653
Author(s):  
Jennifer L. Shaw ◽  
Erin Semmens ◽  
May Okihiro ◽  
Johnnye L. Lewis ◽  
Matthew Hirschfeld ◽  
...  
Keyword(s):  
United States ◽  
Clinical Trials ◽  
Best Practices ◽  
Health Outcomes ◽  
Alaska Native ◽  
Institutional Development ◽  
The United States ◽  
Indigenous Research ◽  
Case Examples ◽  
Indigenous Children

We provide guidance for conducting clinical trials with Indigenous children in the United States. We drew on extant literature and our experience to describe 3 best practices for the ethical and effective conduct of clinical trials with Indigenous children. Case examples of pediatric research conducted with American Indian, Alaska Native, and Native Hawaiian communities are provided to illustrate these practices. Ethical and effective clinical trials with Indigenous children require early and sustained community engagement, building capacity for Indigenous research, and supporting community oversight and ownership of research. Effective engagement requires equity, trust, shared interests, and mutual benefit among partners over time. Capacity building should prioritize developing Indigenous researchers. Supporting community oversight and ownership of research means that investigators should plan for data-sharing agreements, return or destruction of data, and multiple regulatory approvals. Indigenous children must be included in clinical trials to reduce health disparities and improve health outcomes in these pediatric populations. Establishment of the Environmental Influences on Child Health Outcomes Institutional Development Award States Pediatric Clinical Trials Network (ECHO ISPCTN) in 2016 creates a unique and timely opportunity to increase Indigenous children’s participation in state-of-the-art clinical trials.

scholarly journals Are the health benefits of fish oils limited by products of oxidation?

2006 ◽  
Vol 19 (1) ◽  
pp. 53-62 ◽  
Author(s):  
Rufus Turner ◽  
Carlene H McLean ◽  
Karen M Silvers
Keyword(s):  
Clinical Trials ◽  
Health Outcomes ◽  
Fish Oil ◽  
Health Benefits ◽  
Fish Oils ◽  
Negative Effects ◽  
Human Trials ◽  
Beneficial Effects ◽  
By Products

Human clinical trials have shown that fish oils reduce the risk of a variety of disorders including CVD. Despite this, results have been inconsistent. Fish oils are easily oxidised and some fish oils contain higher than recommended levels of oxidised products, but their effects have not been investigated. Recent evidence indicates that dietary oxidised fats can contribute to the development of atherosclerosis and thrombosis. This review summarises findings from cellular, animal and human trials that have examined the effects of oxidised lipids and their potential to affect health outcomes, and proposes that oxidised products in fish oils may attenuate their beneficial effects. More research is required to determine the magnitude of negative effects of fish oil on health outcomes in clinical trials.

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