Advertisement

Topics

Research Participants' Perceptions of Their Experience in Clinical Studies

2014-08-27 03:28:33 | BioPortfolio

Summary

This study will examine how research volunteers experience their participation in studies in order to develop surveys to be used by research centers trying to improve the experience of their participants.

People 18 years of age and older who have participated in an NIH research protocol within the past 2 years as someone with a medical condition under study may be eligible for this study.

Eight participants will participate in a moderator facilitated focus group in a discussion about being in research studies. An observer audiotapes the discussion and takes written notes. The focus group discussion lasts about 1 to 1 hours.

...

Description

The conduct of high quality clinical research is dependent on the ability to recruit and retain subjects who are invested in, understand, and have confidence in the clinical research process. Understanding subjects' experiences as research volunteers is critical to the continual improvement of the processes of clinical research and, subsequently, to enhancing the subject's experience. Heretofore, studies evaluating the subject's comprehension of the informed consent process have served as, at best, an indirect measure of the quality of the subject's experience. Few, if any, studies have assessed the quality and efficacy of the entire clinical research process from the subject's perspective. This study is the first phase of a two-part study designed to directly measure research participants' perceptions of all aspects of the clinical research process (e.g., recruitment, informed consent, education, autonomy and subject's rights, provision of clinical care) for the purposes of improving the clinical research subject's experience.

Obtaining robust, validated data requires a partnership between those with expertise in the design and analysis of surveys, and those who can articulate the needs of research participants and improve the way in which clinical research is conducted. For the former, we will be greatly advantaged by our partnership with NRC Picker, which has committed the resources necessary to assist the survey project development; conduct the focus groups, telephone interviews, and expert advisory group sessions required to further optimize the survey; collaborate in the analysis; and fund the second-stage formal validation of the survey. For the latter, we have assembled a collaborative team of research professionals from the CTSA (Clinical and Translational Science Award) award recipient centers, and interested GCRCs (General Clinical Research Center), with expertise in human subject protections, research ethics, research conduct, education and performance improvement.

The current study entails the recruitment and conduct of up to a total of 15 -18 Focus Groups, each consisting of either 8-10 research subjects (9 -12 groups) or 6-10 research professionals (6 groups), in order achieve the first goal: to assess the key dimensions of the research experience upon which to test the second part of the research, a perception of the research experience survey. The current study will involve 8-11 academic medical centers, enrolling a total of 80-100 research subjects, and 45-60 research professionals in total. A second goal of the project is to describe the process, obstacles and successes of implementing a multi-center protocol across the GCRCs and the CTSA consortium. A subsequent research protocol will concern the fielding and validation of that survey in approximately 3,700 subjects at up to 10 academic medical centers (CTSA and GCRC awardees).

Study Design

Time Perspective: Prospective

Conditions

Participant Satisfaction

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda
Maryland
United States
20892

Status

Completed

Source

National Institutes of Health Clinical Center (CC)

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:28:33-0400

Clinical Trials [358 Associated Clinical Trials listed on BioPortfolio]

Benepali® PEN Patient Satisfaction Survey

The main aim of this study is to ascertain general satisfaction among participants with rheumatic diseases with day-to-day use of the Benepali® prefilled pen by means of a standardised pa...

Impact of the Presurgical Visit of Nursing on the Well-being of the Surgical Patient.

.A surgical intervention involves the participant and his / her family in a very stressful situation with a biopsychosocial alteration of the participant, often presenting a lack of knowle...

Preparing the Personal Physician for Practice (P4)

We would like to better understand how different educational strategies may influence the practice of family medicine. More specifically, we are interested in participant satisfaction with...

A 3D Printed Assistive Technology Intervention

The purpose of this study is to understand the feasibility of using a 3D printer to create tailored assistive technology rehabilitation devices. Specifically, we are investigating if a tai...

Assessment of an Alternative Model of Follow-up of Children and Adolescents With Type 1 Diabetes

The purpose of the study is to look at the effect of replacing the physician only visit by a transmission of information on the participant's current diabetes management and blood glucose ...

PubMed Articles [1274 Associated PubMed Articles listed on BioPortfolio]

Peer-support intervention for postpartum depression: Participant satisfaction and program effectiveness.

Postpartum mood disorders represent a serious problem affecting 10-20% of women and support groups offer a promising intervention modality. The current study examined participant satisfaction with and...

Participant Direction for People With Intellectual and Developmental Disabilities in Medicaid Home and Community Based Services Waivers.

Participant direction allows people with intellectual and developmental disabilities (IDD) and/or their families to direct services; in doing so, participant direction shifts participants from passive...

A longitudinal, observational study examining the relationships of patient satisfaction with services and mental well-being to their clinical course in young people with Type 1 diabetes mellitus during transition from child to adult health services.

We hypothesized that participant well-being and satisfaction with services would be positively associated with a satisfactory clinical course during transition from child to adult health care.

A New Measure of Life Satisfaction: The Riverside Life Satisfaction Scale.

The Satisfaction With Life Scale (Diener, Emmons, Larsen, & Griffin, 1985) has been the dominant measure of life satisfaction since its creation more than 30 years ago. We sought to develop an improv...

The Impact of Residents on Patient Satisfaction.

High-quality physician communication is the foundation for achieving high patient satisfaction. Increasing importance is placed on eliciting feedback from patients. However, there have been few studie...

Medical and Biotech [MESH] Definitions

Repeated reports by a research participant of symptoms, affect, behavior, and cognition close in time to experience and in the participant's natural environment.

Personal satisfaction relative to the work situation.

Customer satisfaction or dissatisfaction with a benefit or service received.

The individual's experience of a sense of fulfillment of a need or want and the quality or state of being satisfied.

The degree to which the individual regards the health care service or product or the manner in which it is delivered by the provider as useful, effective, or beneficial.

More From BioPortfolio on "Research Participants' Perceptions of Their Experience in Clinical Studies"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Alzheimer's Disease
Of all the types of Dementia, Alzheimer's disease is the most common, affecting around 465,000 people in the UK. Neurons in the brain die, becuase  'plaques' and 'tangles' (mis-folded proteins) form in the brain. People with Al...

Collaborations in biotechnology
Commercial and academic collaborations are used throughout the biotechnology and pharmaceutical sector to enhance research and product development. Collaborations can take the form of research and evaluation agreements, licensing, partnerships etc. ...

Mergers & Acquisitions
Commercial and market reports on mergers and acquisitions in the biotechnology, pharmaceutical, medical device and life-science industries. Mergers and acquisitions (abbreviated M&A;) is an aspect of corporate strategy, corporate finance and manageme...


Searches Linking to this Trial