scholarly journals Participant Reactions to a Literacy-Focused, Web-Based Informed Consent Approach for a Genomic Implementation Study

2020 ◽  
Vol 12 (1) ◽  
pp. 1-11 ◽  
Author(s):  
Stephanie A. Kraft ◽  
Kathryn M. Porter ◽  
Devan M. Duenas ◽  
Claudia Guerra ◽  
Galen Joseph ◽  
...  
Keyword(s):  
Informed Consent ◽  
Implementation Study ◽  
Web Based ◽  
Participant Reactions

scholarly journals Communicating With Patients About Software for Enhancing Privacy in Secondary Database Research Involving Record Linkage: Delphi Study (Preprint)

2020 ◽  
Author(s):  
Cason Schmit ◽  
Kobi V Ajayi ◽  
Alva O Ferdinand ◽  
Theodoros Giannouchos ◽  
Gurudev Ilangovan ◽  
...  
Keyword(s):  
Informed Consent ◽  
Record Linkage ◽  
Delphi Study ◽  
Communication Barriers ◽  
Delphi Panel ◽  
Web Based ◽  
Research Issues ◽  
Secondary Database ◽  
Database Research ◽  
Prototype Software

BACKGROUND There is substantial prior research on the perspectives of patients on the use of health information for research. Numerous communication barriers challenge transparency between researchers and data participants in secondary database research (eg, waiver of informed consent and knowledge gaps). Individual concerns and misconceptions challenge the trust in researchers among patients despite efforts to protect data. Technical software used to protect research data can further complicate the public's understanding of research. For example, MiNDFIRL (Minimum Necessary Disclosure For Interactive Record Linkage) is a prototype software that can be used to enhance the confidentiality of data sets by restricting disclosures of identifying information during the record linkage process. However, software, such as MiNDFIRL, which is used to protect data, must overcome the aforementioned communication barriers. One proposed solution is the creation of an interactive web-based frequently asked question (FAQ) template that can be adapted and used to communicate research issues to data subjects. OBJECTIVE This study aims to improve communication with patients and transparency about how complex software, such as MiNDFIRL, is used to enhance privacy in secondary database studies to maintain the public's trust in researchers. METHODS A Delphi technique with 3 rounds of the survey was used to develop the FAQ document to communicate privacy issues related to a generic secondary database study using the MiNDFIRL software. The Delphi panel consisted of 38 patients with chronic health conditions. We revised the FAQ between Delphi rounds and provided participants with a summary of the feedback. We adopted a conservative consensus threshold of less than 10% negative feedback per FAQ section. RESULTS We developed a consensus language for 21 of the 24 FAQ sections. Participant feedback demonstrated preference differences (eg, brevity vs comprehensiveness). We adapted the final FAQ into an interactive web-based format that 94% (31/33) of the participants found helpful or very helpful. The template FAQ and MiNDFIRL source code are available on GitHub. The results indicate the following patient communication considerations: patients have diverse and varied preferences; the tone is important but challenging; and patients want information on security, identifiers, and final disposition of information. CONCLUSIONS The findings of this study provide insights into what research-related information is useful to patients and how researchers can communicate such information. These findings align with the current understanding of health literacy and its challenges. Communication is essential to transparency and ethical data use, yet it is exceedingly challenging. Developing FAQ template language to accompany a complex software may enable researchers to provide greater transparency when informed consent is not possible.

scholarly journals A Patient-Centered Electronic Tool for Weight Loss Outcomes after Roux-en-Y Gastric Bypass

2014 ◽  
Vol 2014 ◽  
pp. 1-7 ◽  
Author(s):  
G. Craig Wood ◽  
Peter Benotti ◽  
Glenn S. Gerhard ◽  
Elaina K. Miller ◽  
Yushan Zhang ◽  
...  
Keyword(s):  
Weight Loss ◽  
Gastric Bypass ◽  
Informed Consent ◽  
Easy Access ◽  
Patient Specific ◽  
Patient Centered ◽  
Web Based ◽  
Electronic Tool ◽  
Large Patient ◽  
Weight Loss Outcomes

Background. Current patient education and informed consent regarding weight loss expectations for bariatric surgery candidates are largely based on averages from large patient cohorts. The variation in weight loss outcomes illustrates the need for establishing more realistic weight loss goals for individual patients. This study was designed to develop a simple web-based tool which provides patient-specific weight loss expectations.Methods. Postoperative weight measurements after Roux-en-Y gastric bypass (RYGB) were collected and analyzed with patient characteristics known to influence weight loss outcomes. Quantile regression was used to create expected weight loss curves (25th, 50th, and 75th %tile) for the 24 months after RYGB. The resulting equations were validated and used to develop web-based tool for predicting weight loss outcomes.Results. Weight loss data from 2986 patients (2608 in the primary cohort and 378 in the validation cohort) were included. Preoperative body mass index (BMI) and age were found to have a high correlation with weight loss accomplishment (P<0.0001for each). An electronic tool was created that provides easy access to patient-specific, 24-month weight loss trajectories based on initial BMI and age.Conclusions. This validated, patient-centered electronic tool will assist patients and providers in patient teaching, informed consent, and postoperative weight loss management.

scholarly journals Improving efficiency of clinical studies by a novel, total digital approach: The Red Heart Study (Preprint)

2020 ◽  
Author(s):  
Karin Schenck-Gustafsson ◽  
Carina Carnlöf ◽  
Mats Jensen-Urstad ◽  
Per Insulander
Keyword(s):  
Informed Consent ◽  
Healthy Volunteers ◽  
Uniform Distribution ◽  
Clinical Studies ◽  
Web Based ◽  
Novel Approach ◽  
Heart Study ◽  
The Mean ◽  
First Time ◽  
Monitor Device

BACKGROUND In general, most clinical studies in patients and healthy volunteers take a longer time to finalize than original planned because of the long recruitment periods. Especially signing the informed consent is time-consuming OBJECTIVE The objectives were to explore if inclusion of a large number of participants could be done quickly by using a total digital approach both for information and signing of informed consent and if a totally web-based inclusion would result in a geographically more uniform distribution of participants METHODS In the Red Heart Study, women with palpitations were intensively studied during two months by means of a handheld ECG monitor device (Coala Heart Monitor), It connects to a smartphone or tablet so the participants can get an immediate response of the results. Recruitment, study information and signing the informed consent were total digital. The informed consent was signed digitally with the help of Swedish eAuthentication (Bank ID). RESULTS Between March and May 2018, 2 424 persons announced interest to participate in the study. On June 19th, 2018, presumptive participants were invited to log in to the website to answer baseline questionnaires and sign informed consent. The recruitment was completed on the 13th of July-after 25 days with 1 089 women included. About 100°000 thumb ECG and 100°000 chest ECG recordings were performed. The mean age of the women was 56±11 years (range 21-88 years). Thirty-five participants were 75 years or older. No participant had any difficulties with this the full digital approach. The participants were evenly distributed between living in the countryside (n=525) and in the cities (n=438). CONCLUSIONS To the best of our knowledge, this is the first-time researchers have used eAuthentication at online signing of informed consent. Fully digitalized inclusion recruitment of 1 089 participants was done in 45 days. This novel approach also resulted in a more evenly geographically distribution of participants CLINICALTRIAL ISRCTN22495299

scholarly journals A Web-Based Decision Tool to Improve Contraceptive Counseling for Women With Chronic Medical Conditions: Protocol For a Mixed Methods Implementation Study

2018 ◽  
Vol 7 (4) ◽  
pp. e107 ◽  
Author(s):  
Justine P Wu ◽  
Laura J Damschroder ◽  
Michael D Fetters ◽  
Brian J Zikmund-Fisher ◽  
Benjamin F Crabtree ◽  
...  
Keyword(s):  
Mixed Methods ◽  
Chronic Medical Conditions ◽  
Implementation Study ◽  
Medical Conditions ◽  
Decision Tool ◽  
Web Based ◽  
Contraceptive Counseling

scholarly journals Receiving the Initial Down Syndrome Diagnosis: A Comparison of Prenatal and Postnatal Parent Group Experiences

2013 ◽  
Vol 51 (6) ◽  
pp. 446-457 ◽  
Author(s):  
Briana S. Nelson Goff ◽  
Nicole Springer ◽  
Laura Cline Foote ◽  
Courtney Frantz ◽  
Madison Peak ◽  
...  
Keyword(s):  
Down Syndrome ◽  
Medical Professionals ◽  
Adjustment Process ◽  
Grief And Loss ◽  
Web Based ◽  
Negative Experiences ◽  
Early Experiences ◽  
Group Experiences ◽  
Loss Experience ◽  
Participant Reactions

Abstract This study explored the preliminary experiences of parents upon learning of their child's diagnosis of Down syndrome. Qualitative data from a web-based, national survey were analyzed based on two groups: prenatal (n  =  46) or postnatal (n  =  115) diagnosis. Three primary categories emerged from the data analysis: prenatal screening/testing decisions by parents, the adjustment process for parents, and postdiagnosis resources and support for parents. Participants' rationale behind pursuing testing ranged from wanting to be better prepared to not pursuing testing because it was not a factor in continuing the pregnancy. Participant reactions to the diagnosis involved a range of intense preliminary emotions; participants described their extreme grief and loss experience at the initial news of the diagnosis, which also was ambiguous in nature and required differing timelines of adjustment. Finally, participants described experiences with medical professionals, information/education, and faith/religion as resources and areas of support, although not all were described as positive in nature. Participants in both groups identified having negative experiences with medical professionals during the diagnosis process. The results indicated the importance of these early experiences for parents of children with Down syndrome and emphasize providing effective education, resources, and practical information from reliable sources.

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