Inclusion of Children in Clinical Research: Lessons Learned From Mothers of Diabetic Children

2001 ◽  
Vol 10 (2) ◽  
pp. 140-162 ◽  
Author(s):  
Pamela K. Pletsch ◽  
Patricia E. Stevens
Keyword(s):  
Qualitative Study ◽  
Clinical Research ◽  
Clinical Studies ◽  
Lessons Learned ◽  
Diabetic Children

Nine mothers of diabetic children participated in a qualitative study about the factors that influenced them to consent to havand how they evaluated the clinical studies their children had been in. Results suggest that mothers engage in a personal calculus before making a choice to consent.

scholarly journals Gap between real-world data and clinical research within hospitals in China: a qualitative study

BMJ Open ◽  
2020 ◽  
Vol 10 (12) ◽  
pp. e038375
Author(s):  
Feifei Jin ◽  
Chen Yao ◽  
Xiaoyan Yan ◽  
Chongya Dong ◽  
Junkai Lai ◽  
...  
Keyword(s):  
Qualitative Study ◽  
Clinical Research ◽  
Real World ◽  
Data Standards ◽  
Medical Record Data ◽  
Real World Data ◽  
World Data ◽  
Electronic Medical Record Data ◽  
Research Platform ◽  
Record Data

ObjectiveTo investigate the gap between real-world data and clinical research initiated by doctors in China, explore the potential reasons for this gap and collect different stakeholders’ suggestions.DesignThis qualitative study involved three types of hospital personnel based on three interview outlines. The data analysis was performed using the constructivist grounded theory analysis process.SettingSix tertiary hospitals (three general hospitals and three specialised hospitals) in Beijing, China, were included.ParticipantsIn total, 42 doctors from 12 departments, 5 information technology managers and 4 clinical managers were interviewed through stratified purposive sampling.ResultsElectronic medical record data cannot be directly downloaded into clinical research files, which is a major problem in China. The lack of data interoperability, unstructured electronic medical record data and concerns regarding data security create a gap between real-world data and research data. Updating hospital information systems, promoting data standards and establishing an independent clinical research platform may be feasible suggestions for solving the current problems.ConclusionsDetermining the causes of gaps and targeted solutions could contribute to the development of clinical research in China. This research suggests that updating the hospital information system, promoting data standards and establishing a clinical research platform could promote the use of real-world data in the future.

Exploring parents’ perceptions of the value of pediatric genetic counseling patient letters: A qualitative study presenting lessons learned

2021 ◽  
Author(s):  
Courtney Brown ◽  
Katharine J. Head ◽  
Jane Hartsock ◽  
Katelyn Burns ◽  
Theodore E. Wilson ◽  
...  
Keyword(s):  
Genetic Counseling ◽  
Qualitative Study ◽  
Lessons Learned

scholarly journals In Vitro,In Vivo, and Clinical Studies of Tedizolid To Assess the Potential for Peripheral or Central Monoamine Oxidase Interactions

2013 ◽  
Vol 57 (7) ◽  
pp. 3060-3066 ◽  
Author(s):  
S. Flanagan ◽  
K. Bartizal ◽  
S. L. Minassian ◽  
E. Fang ◽  
P. Prokocimer
Keyword(s):  
Blood Pressure ◽  
Monoamine Oxidase ◽  
Clinical Research ◽  
Systolic Blood Pressure ◽  
Clinical Studies ◽  
Geometric Mean ◽  
Interaction Study ◽  
Mao B ◽  
Mao A

ABSTRACTTedizolid phosphate is a novel oxazolidinone prodrug whose active moiety, tedizolid, has improved potency against Gram-positive pathogens and pharmacokinetics, allowing once-daily administration. Given linezolid warnings for drug-drug and drug-food interactions mediated by monoamine oxidase (MAO) inhibition, including sporadic serotonergic toxicity, these studies evaluated tedizolid for potential MAO interactions.In vitro, tedizolid and linezolid were reversible inhibitors of human MAO-A and MAO-B; the 50% inhibitory concentration (IC50) for tedizolid was 8.7 μM for MAO-A and 5.7 μM for MAO-B and 46.0 and 2.1 μM, respectively, with linezolid. Tedizolid phosphate was negative in the mouse head twitch model of serotonergic activity. Two randomized placebo-controlled crossover clinical studies assessed the potential of 200 mg/day tedizolid phosphate (at steady state) to enhance pressor responses to coadministered oral tyramine or pseudoephedrine. Sensitivity to tyramine was determined by comparing the concentration of tyramine required to elicit a ≥30-mmHg increase in systolic blood pressure (TYR30) when administered with placebo versus tedizolid phosphate. The geometric mean tyramine sensitivity ratio (placebo TYR30/tedizolid phosphate TYR30) was 1.33; a ratio of ≥2 is considered clinically relevant. In the pseudoephedrine study, mean maximum systolic blood pressure was not significantly different when pseudoephedrine was coadministered with tedizolid phosphate versus placebo. In summary, tedizolid is a weak, reversible inhibitor of MAO-A and MAO-Bin vitro. Provocative testing in humans and animal models failed to uncover significant signals that would suggest potential for hypertensive or serotonergic adverse consequences at the therapeutic dose of tedizolid phosphate. Clinical studies are registered atwww.clinicaltrials.govas NCT01539473 (tyramine interaction study conducted at Covance Clinical Research Center, Evansville, IN) and NCT01577459 (pseudoephedrine interaction study conducted at Vince and Associates Clinical Research, Overland Park, KS).

scholarly journals Clinical Research Informatics: Contributions from 2017

2018 ◽  
Vol 27 (01) ◽  
pp. 177-183 ◽  
Author(s):  
Christel Daniel ◽  
Dipak Kalra ◽  
Keyword(s):  
Electronic Health Records ◽  
Clinical Research ◽  
Association Studies ◽  
Bias Reduction ◽  
Lessons Learned ◽  
Editorial Team ◽  
Private Industry ◽  
Health Records ◽  
Clinical Research Informatics ◽  
Electronic Health

Objectives: To summarize key contributions to current research in the field of Clinical Research Informatics (CRI) and to select best papers published in 2017. Method: A bibliographic search using a combination of MeSH descriptors and free terms on CRI was performed using PubMed, followed by a double-blind review in order to select a list of candidate best papers to be then peer-reviewed by external reviewers. A consensus meeting between the two section editors and the editorial team was organized to finally conclude on the selection of best papers. Results: Among the 741 returned papers published in 2017 in the various areas of CRI, the full review process selected five best papers. The first best paper reports on the implementation of consent management considering patient preferences for the use of de-identified data of electronic health records for research. The second best paper describes an approach using natural language processing to extract symptoms of severe mental illness from clinical text. The authors of the third best paper describe the challenges and lessons learned when leveraging the EHR4CR platform to support patient inclusion in academic studies in the context of an important collaboration between private industry and public health institutions. The fourth best paper describes a method and an interactive tool for case-crossover analyses of electronic medical records for patient safety. The last best paper proposes a new method for bias reduction in association studies using electronic health records data. Conclusions: Research in the CRI field continues to accelerate and to mature, leading to tools and platforms deployed at national or international scales with encouraging results. Beyond securing these new platforms for exploiting large-scale health data, another major challenge is the limitation of biases related to the use of “real-world” data. Controlling these biases is a prerequisite for the development of learning health systems.

Abstract 167: Factors Influencing the Decision to Accept or Decline to Participate in Clinical Research: A Qualitative Study

2018 ◽  
Vol 11 (suppl_1) ◽  
Author(s):  
Fiona Ecarnot ◽  
Romain Chopard ◽  
Francois Schiele ◽  
Nicolas Meneveau
Keyword(s):  
Clinical Trial ◽  
Qualitative Study ◽  
Clinical Research ◽  
Emotional Health ◽  
Research Participation ◽  
Two Dimensions ◽  
Trial Participation ◽  
Main Concern ◽  
Inclusion Criteria ◽  
General Behaviour

Introduction: Guidelines rely on evidence-based data, and clinical research is key to providing this evidence-base. Yet the factors that influence a patient’s decision to participate (or not) in research remain poorly documented. We aimed to investigate the factors that determine the decision to accept or decline clinical trial participation, using a qualitative approach. Methods: Single-centre, qualitative study using semi-directive interviews with patients (pts) who had been invited to participate in a randomized clinical trial and who had given their decision. Both pts who refused and pts who accepted were included. There were no inclusion criteria; all pts who met the inclusion criteria of the selected trial and had been approached for consent were eligible. Pts also completed a questionnaire rating 16 statements examining reasons for accepting or declining trial entry. Verbatim from the interviews were analysed using a grounded theory (GT) approach. Results: To date, 14 patients have been interviewed; average age 75±7 years. Two pts did not know if they were currently participating in a trial or not; 1 said he was not participating although he had provided consent. From a GT perspective, the main concern of patients does not appear to be the question of research participation, but rather the fact of being sick, and their overriding preoccupation is how to return to their previous state of wellbeing and overcome the current acute episode. Regarding the decision to participate in research, the main themes that arose were: (1) the positive value of the trial for the patient (benefitting from the intervention; interest in receiving closer and/or more regular follow-up due to trial participation), although some pts clearly do not understand the concept of randomization; (2) the level of engagement in the process of care (some pts do not bother to read the information given to them, but just accept what is proposed without question, while others decline immediately without reading trial information). Two dimensions emerge, namely physical and emotional health, with a spectrum ranging from fragile to robust. Where the patient is situated on this spectrum appears to influence their attitude towards research participation. Conclusions: The decision to participate (or not) in clinical research appears to be more related to the patient’s general behaviour and attitude when sick, rather than any specific trial-related constraints or advantages. The level of comprehension of pts who have been through the consent process casts a doubt on the “informed” character of the consent.

Coagulation Signalling and Metabolic Disorders: Lessons Learned from Animal Models

2019 ◽  
Vol 39 (02) ◽  
pp. 164-172 ◽  
Author(s):  
Thati Madhusudhan ◽  
Wolfram Ruf
Keyword(s):  
Insulin Resistance ◽  
Clinical Studies ◽  
Metabolic Disorders ◽  
Oral Anticoagulants ◽  
Direct Oral Anticoagulants ◽  
Lessons Learned ◽  
Metabolic Reprogramming ◽  
Metabolic Adaptation ◽  
Metabolic Inflammation ◽  
Cardiometabolic Disorders

AbstractNutrient excess in obesity drives metabolic reprogramming in multiple tissues involving extensive interorgan and intercellular crosstalk. Experimental and clinical studies show that prolonged nutrient excess often compromises metabolic adaptation propagating proobesogenic and proinflammatory responses. Chronic inflammation further promotes insulin resistance and associated comorbidities. Obesity and type 2 diabetes are characterized by a hypercoagulable state and clinical studies show a strong correlation of markers of coagulation activation in metabolic disorders. Coagulation protease-dependent signalling via protease-activated receptors is intimately associated with inflammation. The experimental evidence supports roles of tissue factor and G protein coupled protease-activated receptor-2 signalling in the regulation of insulin resistance and metabolic inflammation in diet-induced obesity. Likewise, increases in plasminogen activator inhibitor-1 levels and fibrin-driven inflammation promote insulin resistance in obesity. Additionally, impaired thrombomodulin-dependent protein C activation is mechanistically linked to diabetic kidney disease. Given the increased usage of direct oral anticoagulants, understanding the role of specific coagulation proteases in regulation of metabolic inflammation is highly relevant and might provide insights into the design of novel treatment regimens for patients suffering from thromboinflammatory and cardiometabolic disorders.

Sign in / Sign up

Export Citation Format

Share Document