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Journal Description

JMIR Formative Research (JFR) (a sister journal of J Med Internet Res (JMIR) and JMIR mHealth & uHealth, the leading eHealth and mHealth journals by impact factor) publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research and preliminary results. While the original focus was on the design of medical and health-related research and technology innovations, JFR publishes studies from all areas of medical and health research.

Formative research is research that occurs before a program is designed and implemented, or while a program is being conducted. Formative research can help

  • define and understand populations in need of a intervention or public health program
  • create programs that are specific to the needs of those populations
  • ensure programs are acceptable and feasible to users before launching
  • improve the relationship between users and agencies/research groups
  • demonstrate the feasibility, use, satisfaction with, or problems with a program before large-scale summative evaluation (looking at health outcomes)

Many funding agencies will expect some sort of pilot/feasibility/process evaluation before funding a larger study such as a Randomized Controlled Trial (RCT).

Formative research should be an integral part of developing programs or adapting programs, and should be used while the program is on-going to help refine and improve program activities. Thus, formative evaluation can and should also occur in form of a process evaluation alongside a summative evaluation such as a RCT.

This journal fills an important gap in the academic journals landscape, as it publishes sound and peer-reviewed formative research that is criticial for investigators to apply for further funding, but that is usually not published in outcomes-focussed medical journals aiming for impact and generalizability.

 

Recent Articles:

  • A person experiencing stress. Source: Pexels; Copyright: Nathan Cowley; URL: https://www.pexels.com/photo/man-in-blue-and-brown-plaid-dress-shirt-touching-his-hair-897817/; License: Licensed by JMIR.

    Effects of Cold Stimulation on Cardiac-Vagal Activation in Healthy Participants: Randomized Controlled Trial

    Abstract:

    Background: The experience of psychological stress has not yet been adequately tackled with digital technology by catering to healthy individuals who wish to reduce their acute stress levels. For the design of digitally mediated solutions, physiological mechanisms need to be investigated that have the potential to induce relaxation with the help of technology. Research has shown that physiological mechanisms embodied in the face and neck regions are effective for diminishing stress-related symptoms. Our study expands on these areas with the design for a wearable in mind. As this study charts new territory in research, it also is a first evaluation of the viability for a wearables concept to reduce stress. Objective: The objectives of this study were to assess whether (1) heart rate variability would increase and (2) heart rate would decrease during cold stimulation using a thermode device compared with a (nonstimulated) control condition. We expected effects in particular in the neck and cheek regions and less in the forearm area. Methods: The study was a fully randomized, within-participant design. Volunteer participants were seated in a laboratory chair and tested with cold stimulation on the right side of the body. A thermode was placed on the neck, cheek, and forearm. We recorded and subsequently analyzed participants’ electrocardiogram. The cold stimulation was applied in 16-second intervals over 4 trials per testing location. The control condition proceeded exactly like the cold condition, except we manipulated the temperature variable to remain at the baseline temperature. We measured heart rate as interbeat intervals in milliseconds and analyzed root mean square of successive differences to index heart rate variability. We analyzed data using a repeated-measures ANOVA (analysis of variance) approach with 2 repeated-measures factors: body location (neck, cheek, forearm) and condition (cold, control). Results: Data analysis of 61 participants (after exclusion of outliers) showed a main effect and an interaction effect for body location and for condition, for both heart rate and heart rate variability. The results demonstrate a pattern of cardiovascular reactivity to cold stimulation, suggesting an increase in cardiac-vagal activation. The effect was significant for cold stimulation in the lateral neck area. Conclusions: The results confirmed our main hypothesis that cold stimulation at the lateral neck region would result in higher heart rate variability and lower heart rate than in the control condition. This sets the stage for further investigations of stress reduction potential in the neck region by developing a wearable prototype that can be used for cold application. Future studies should include a stress condition, test for a range of temperatures and durations, and collect self-report data on perceived stress levels to advance findings.

  • Samuel Mugisha, CEO of Innovation Streams, giving a presentation on Stre@mline. Source: Image created by the Authors; Copyright: The Authors; URL: http://formative.jmir.org/2018/2/e20/; License: Creative Commons Attribution (CC-BY).

    A Locally Developed Electronic Health Platform in Uganda: Development and Implementation of Stre@mline

    Abstract:

    Background: Electronic health records (EHRs) are especially important in low-resource settings due to their potential to address unique challenges such as a high number of patients requiring long-term treatments who are lost to follow-up, the frequent shortages of essential drugs, poor maintenance and storage of records, and inefficient clinical triaging. However, there is a lack of affordable and practical EHR solutions. Stre@mline is an EHR platform that has been locally developed by Ugandan clinicians and engineers in Southwestern Uganda. It is tailored to the specific context and needs of low-resource hospitals. It operates without internet access, incorporates locally relevant standards and key patient safety features, has a medication inventory management component, has local technical support available, and is economically sustainable without funding from international donors. Stre@mline is currently used by over 60,000 patients at 2 hospitals, with plans to expand across Uganda. Objective: The purpose of this article is to describe the key opportunities and challenges in EHR development in sub-Saharan Africa and to summarize the development and implementation of a “Made-for-Africa” EHR, Stre@mline, and how it has led to improved care for over 60,000 vulnerable patients in a rural region of Southwestern Uganda. Methods: A quantitative user survey consisting of a set of 33 questions on usability and performance was conducted at Kisiizi Hospital. Users responded to each question through a Likert scale with the values of strongly disagree, disagree, agree, and strongly agree. Through purposive sampling, 30 users were identified and 28 users completed the survey. Results: We found that users were generally very satisfied with the ease of use of Stre@mline, with 96% (27/28) finding it easy to learn and 100% (28/28) finding it easy to use. Users found that Stre@mline was helpful in improving both clinical efficiency and enhancing patient care. Conclusions: The partnership of local clinicians and developers is crucial to the design and adoption of user-centered technologies tailored to the specific needs of low-resource settings. The EHR described here could serve as a model for the development of future technologies suitable for developing countries.

  • Source: Pixabay; Copyright: terimakasih0; URL: https://pixabay.com/en/texting-mobile-phones-hands-two-1490691/; License: Public Domain (CC0).

    Adolescent Preferences and Design Recommendations for an Asthma Self-Management App: Mixed-Methods Study

    Abstract:

    Background: Approximately 10% of adolescents in the United States have asthma. Adolescents widely use apps on mobile phones and tablet technology for social networking and gaming purposes. Given the increase in recreational app use among adolescents, leveraging apps to support adolescent asthma disease management seems warranted. However, little empirical research has influenced asthma app development; adolescent users are seldom involved in the app design process. Objective: The aim of this mixed-methods study was to assess adolescent preferences and design recommendations for an asthma self-management app. Methods: A total of 20 adolescents with persistent asthma (aged 12-16 years) provided feedback on two asthma self-management apps during in-person semistructured interviews following their regularly scheduled asthma clinic visit and via telephone 1 week later. Interviews were audiorecorded, transcribed verbatim, analyzed using SPSS v24, and coded thematically using MAXQDA 11. Results: Regarding esthetics, app layout and perceived visual simplicity were important to facilitate initial app use. Adolescents were more likely to continually engage with apps that were deemed useful and met their informational needs. Adolescents also desired app features that fit within their existing paradigm or schema and included familiar components (eg, medication alerts that appear and sound like FaceTime notifications and games modeled after Quiz Up and Minecraft), as well as the ability to customize app components. They also suggested that apps include other features, such as an air quality tracker and voice command. Conclusions: Adolescents desire specific app characteristics including customization and tailoring to meet their asthma informational needs. Involving adolescents in early stages of app development is likely to result in an asthma app that meets their self-management needs and design preferences and ultimately the adoption and maintenance of positive asthma self-management behaviors.

  • Congenital heart disease transition checklist for mobile app (montage). Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://formative.jmir.org/2018/2/e16/; License: Creative Commons Attribution (CC-BY).

    Improving Transitions of Care for Young Adults With Congenital Heart Disease: Mobile App Development Using Formative Research

    Abstract:

    Background: Congenital heart diseases (CHDs) are the most common type of birth defects. Improvements in CHD care have led to approximately 1.4 million survivors reaching adulthood. Successful transition and transfer from pediatric to adult care is crucial. Unfortunately, less than 30% of adolescents with CHD successfully transition to adult care; this number is lower for minority and lower socioeconomic status populations. Few CHD programs exist to facilitate successful transition. Objective: The goal of our study was to describe the formative research used to develop a prototype mobile app to facilitate transition to adult care for adolescents with CHD. Methods: A literature search about best practices in transition medicine for CHD was conducted to inform app development. Formative research with a diverse group of CHD adolescents and their parents was conducted to determine gaps and needs for CHD transition to adult care. As part of the interview, surveys assessing transition readiness and CHD knowledge were completed. Two adolescent CHD expert panels were convened to inform educational content and app design. Results: The literature review revealed 113 articles, of which 38 were studies on transition programs and attitudes and 3 identified best practices in transition specific to CHD. A total of 402 adolescents aged 15 to 22 years (median 16 years) participated in semistructured interviews. The group was racially and ethnically diverse (12.6% [51/402] African American and 37.8% [152/402] Latino) and 42.0% (169/402) female; 36.3% (146/402) received public insurance. Most adolescents (313/402, 76.7%) had moderate or severe CHD complexity and reported minimal CHD understanding (79.0% [275/348] of those aged 15 to 17 years and 61.1% [33/54] of those aged 18 to 22 years). Average initial transition readiness score was 50.9/100, meaning that transition readiness training was recommended. When participants with moderate to severe CHD (313/402, 77.9%) were asked about technology use, 94.2% (295/313) reported having access to a mobile phone. Interviews with parents revealed limited interactions with the pediatric cardiologist about transition-related topics: 79.4% (331/417) reported no discussions regarding future family planning, and 55.2% (230/417) reported the adolescent had not been screened for mental health concerns (depression, anxiety). Further, 66.4% (277/417) reported not understanding how health care changes as adolescents become adults. Adolescents in the expert panels (2 groups of 3 adolescents each) expressed interest in a CHD-specific tailored app consisting of quick access to specific educational questions (eg, “Can I exercise?”), a CHD story-blog forum, a mentorship platform, a question and answer space, and a checklist to facilitate transition. They expressed interest in using the app to schedule CHD clinic appointments and receive medication reminders. Based on this data, a prototype mobile app was created to assist in adolescent CHD transition. Conclusions: Formative research revealed that most adolescents with CHD had access to mobile phones, were not prepared for transition to adult care, and were interested in an app to facilitate transition to adult CHD care. Understanding adolescent and parent needs, interests, and concerns helped in the development of a mobile app with a broader, tailored approach for adolescents with CHD.

  • Source: Pexels; Copyright: Kaboompics; URL: https://www.pexels.com/photo/women-typing-on-the-notebook-6168/; License: Public Domain (CC0).

    Adapting a Behavioral Weight Loss Intervention for Delivery via Facebook: A Pilot Series Among Low-Income Postpartum Women

    Abstract:

    Background: Efforts to translate evidence-based weight loss interventions, such as the Diabetes Prevention Program (DPP), to low-income postpartum women have resulted in poor intervention attendance and high attrition. Strategies that improve engagement and retention in this population are needed to maximize the reach of evidence-based weight loss interventions. Objective: The objective of this study was to adapt a DPP-based weight loss intervention (Fresh Start) for Facebook delivery and to evaluate its feasibility among low-income postpartum women. Methods: This study comprised 3 single-group pilot studies where feasibility outcomes iteratively informed changes from one pilot to the next. We paralleled the in-person program for Facebook delivery by translating the protocol to a content library of Facebook posts with additional posts from lifestyle coaches. Low-income postpartum women were recruited from Women, Infants, and Children (WIC) clinics in Worcester, Massachusetts. Participants were enrolled into a 16-week weight loss intervention delivered via Facebook. During the first 8 weeks, Facebook intervention posts were delivered 2 times per day, with additional posts from coaches aiming to stimulate interaction among participants or respond to participants’ questions and challenges. For the following 8 weeks, posts were delivered once per day without additional coaching. Feasibility outcomes were engagement (defined by number of likes, comments, and posts measured throughout intervention delivery), acceptability, and retention (survey at follow-up and assessment completion rate, respectively). Changes in weight were also assessed at baseline and follow-up. Results: Pilot 1 had a retention rate of 89% (24/27), and on average, 62% (17/27) of women actively engaged with the group each week during the 8-week coached phase. Mean weight loss was 2.6 (SD 8.64) pounds, and 79% (19/27) would recommend the program to a friend. Pilot 2 had a retention rate of 83% (20/24), and on average, 55% (13/24) of women actively engaged with the group weekly during the 8-week coached phase. Mean weight loss was 2.5 (SD 9.23) pounds, and 80% (16/24) would recommend the program to a friend. Pilot 3 had a retention rate of 88% (14/16), and on average, 67% (11/16) of women actively engaged with the group weekly during the 8-week coached phase. Mean weight loss was 7.0 (SD 11.6) pounds, and 100% (16/16) would recommend the program to a friend. Conclusions: Our findings demonstrated that a Facebook-delivered intervention was acceptable and could be feasibly delivered to low-income postpartum women. Future research is needed to evaluate the efficacy of a Facebook-delivered weight loss intervention.

  • StresProffen illustration. Source: Image created by the Authors; Copyright: The Authors; URL: http://formative.jmir.org/2018/2/e19; License: Creative Commons Attribution (CC-BY).

    A Stress Management App Intervention for Cancer Survivors: Design, Development, and Usability Testing

    Abstract:

    Background: Distress is prevalent in cancer survivors. Stress management interventions can reduce distress and improve quality of life for cancer patients, but many people with cancer are unfortunately not offered or able to attend such in-person stress management interventions. Objective: The objective of this study was to develop an evidence-based stress management intervention for patients living with cancer that can be delivered electronically with wide reach and dissemination. This paper describes the design and development process of a technology-based stress management intervention for cancer survivors, including the exploration phase, intervention content development, iterative software development (including design, development, and formative evaluation of low- and high-level prototypes), and security and privacy considerations. Methods: Design and development processes were iterative and performed in close collaboration with key stakeholders (N=48). In the exploration phase, identifying needs and requirements for the intervention, 28 participants gave input, including male and female cancer survivors (n=11) representing a wide age range (31-81 years) and cancer diagnoses, healthcare providers (n=8) including psychosocial oncology experts, and eHealth experts (n=9) including information technology design and developers. To ensure user involvement in each phase various user-centered design and service design methods were included, such as interviews, usability testing, and think aloud processes. Overall, participants were involved usability testing in the software development and formative evaluation phase, including cancer survivors (n=6), healthy volunteers (n=7), health care providers (n=2), and eHealth experts (n=5). Intervention content was developed by stress management experts based on well-known cognitive behavioral stress management strategies and adjusted to electronic format through multiple iterations with stakeholders. Privacy and security issues were considered throughout. Results: The design and development process identified a variety of stakeholder requirements. Cancer survivors preferred stress management through a mobile app rather than through a personal computer (PC) and identified usefulness, easy access, user friendliness, use of easily understandable language, and many brief sections rather than longer ones as important components of the intervention. These requirements were also supported by recommendations from health care providers and eHealth experts. The final intervention was named StressProffen and the hospital Privacy and Security Protection Committee was part of the final intervention approval to also ensure anchoring in the hospital organization. Conclusions: Interventions, even evidence-based, have little impact if not actively used. This study illustrates how user-centered design and service design can be applied to identify and incorporate essential stakeholder aspects in the entire design and development process. In combination with evidence-based concepts, this process facilitated development of a stress management intervention truly designed for the end users, in this case, cancer survivors. Trial Registration: ClinicalTrials.gov NCT02939612; https://clinicaltrials.gov/ct2/show/NCT02939612 (Archived at WebCite at http://www.webcitation.org/71l9HcfcB)

  • Source: Pixabay; Copyright: rawpixel; URL: https://pixabay.com/en/african-america-asian-chat-3533081/; License: Public Domain (CC0).

    Conversation Within a Facebook Smoking Cessation Intervention Trial For Young Adults (Tobacco Status Project): Qualitative Analysis

    Abstract:

    Background: Smoking cessation interventions delivered through social media have the potential to engage young people in behavior change. Objective: The aim of this study was to describe participant-posted messages in a Facebook smoking cessation intervention for young adults to discern support for behavior change. Methods: We qualitatively analyzed data from the treatment arm of a randomized trial testing the efficacy of the Tobacco Status Project Facebook intervention. Young adults (N=138) aged 18-25 years (female: 81/138, 58.7%; white: 101/138, 73.2%; mean age 21 years) were recruited using Facebook and placed into one of the 15 secret Facebook groups based on readiness-to-quit smoking. Messages posted to groups for 90 consecutive days were tailored to readiness-to-quit: Not Ready (46/138, 33.3%), Thinking (66/138, 47.8%), and Getting Ready (26/138, 18.8%). Groups were randomized to receive up to US $90 for posting or no incentive. Two independent coders conducted open coding of user posts. We considered content by readiness-to-quit group and incentive condition. Results: There were 4 dominant themes across all groups: coping skills, friends and family, motivation to quit, and benefits of quitting. The dominant themes in Not Ready groups were friends and family (incentive) and motivation to quit (no incentive), whereas coping skills was the dominant theme in Thinking and Getting Ready groups. The expression of themes varied by readiness-to-quit group but not by incentive condition. Conclusions: Intervention messages tailored to readiness-to-quit appear useful in eliciting the desired responses from young adult smokers, with limited influence by monetary incentive. Trial Registration: ClinicalTrials.gov NCT02207036; https://clinicaltrials.gov/ct2/show/NCT02207036 (Archived by WebCite at http://www.webcitation.org/722XAEAAz)

  • Source: Pixabay; Copyright: rawpixel; URL: https://pixabay.com/en/business-business-people-3421076/; License: Public Domain (CC0).

    Assessing the Feasibility and Pre-Post Impact Evaluation of the Beta (Test) Version of the BeUpstanding Champion Toolkit in Reducing Workplace Sitting: Pilot...

    Abstract:

    Background: The Web-based, evidence-informed BeUpstanding Champion Toolkit was developed to provide employers (via a “train-the-champion approach”) with resources and support to help in reducing prolonged sitting in their own desk-based workplace. As part of a five-phase research-to-dissemination process, this study reports on the evaluation of the beta (test) version of this toolkit (Phase 2). Objective: The objective of our study was to evaluate (1) the implementation of the toolkit by workplace champions and (2) the impact of the toolkit on sitting (primary outcome), standing, and moving; use of activity-promoting strategies; knowledge and attitudes; and indicators of health and work performance. Methods: An implementation study using a pre-post design was conducted in 7 desk-based workplaces in Australia (September 2015 to May 2016), with work teams (one per workplace) purposively recruited to ensure representation across a range of sectors (white- or blue-collar), organizational sizes (small or medium or large), and locations (metropolitan or regional). All staff within participating teams were invited to participate in the relevant toolkit activities. Implementation outcomes (time commitment required by champions and toolkit activities completed) were collected from each champion via telephone interviews. Changes in impact outcomes, measured via a Web-based questionnaire completed by employees at baseline and 3 months postimplementation, were assessed using mixed models, correcting for clustering. Results: Champions reported a 30-60 minutes per week time commitment to the toolkit activities. All teams formed a wellbeing committee and sent the staff surveys at both time points; most champions held a staff consultation workshop (6/7), identified team-level strategies within that workshop (5/7), used the communication resources provided within the toolkit (emails, posters; 6/7), and completed the action plan (5/7). In total, 52% (315 of ≈600) employees participated in at least one survey and 97 (16%) participated in both. At follow-up, there was a significant (P<.05) reduction in self-reported workplace sitting time compared to baseline (−6.3%, 95% CI −10.1 to −2.5; n=85) equating to ≈30 minutes per workday. Significant benefits were also observed for the use of activity-promoting strategies, with small, nonsignificant changes observed for knowledge and attitudes and indicators of health and work performance. Conclusions: The beta version of the BeUpstanding Champion Toolkit was feasible to implement and effective in reducing self-reported workplace sitting across a broad range of desk-based workplaces. The next phase (Phase 3) will build on these findings to optimize the toolkit for wider-scale implementation and longer term evaluation.

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://formative.jmir.org/2018/2/e10125/; License: Creative Commons Attribution (CC-BY).

    Game Plan: Development of a Web App Designed to Help Men Who Have Sex With Men Reduce Their HIV Risk and Alcohol Use

    Abstract:

    Background: Men who have sex with men (MSM) are at high risk for HIV, and alcohol use is a major risk factor for HIV infection. Internet-facilitated brief interventions have been shown to reduce alcohol use and HIV-risk behavior in other at-risk populations, but have so far incorporated limited content and have not been tested among MSM. Objective: This manuscript describes Game Plan, an interactive, tablet-optimized web application designed to help heavy drinking, high-risk MSM consider reducing their alcohol use and sexual risk behavior. In this paper, we discuss the rationale, goals, and flow for each of Game Plan’s components, which were modelled after common in-person and web-based brief motivational interventions for these behaviors. Methods: The development of Game Plan was informed by a thorough user-focused design research process that included (1) audits of existing interventions, (2) focus groups with stakeholders and (3) intended users (high-risk, heavy drinking MSM), and (4) usability testing. The aesthetic, features, and content of the app were designed iteratively throughout this process Results: The fully-functional Game Plan app provides (1) specific and personal feedback to users about their level of risk, (2) exercises to help prompt users to reflect on whether their current behavior aligns with other important life goals and values, and for those open to change, (3) exercises to help users understand factors that contribute to risk, and (4) a change planning module. In general, this flow was constructed to roughly align with the two phases described in early accounts of motivational interviewing (MI): (1) Content intended to elicit intrinsic motivation for change, and when/if sufficient motivation is present, (2) content intended to translate that motivation into specific goals and plans for change. This sequence first focuses on the user’s HIV risk behavior, followed by their alcohol use and the connection between the two. The app’s overall aesthetic (eg, branding, color palettes, icons/graphics) and its onboarding sequence was also designed to align with the “spirit” of MI by conveying respect for autonomy, open-mindedness (ie, avoiding judgment), and empathy. Conclusions: Should future research support its efficacy in facilitating behavior change, Game Plan could represent a wide-reaching and scalable tool that is well-suited for use in settings where delivering evidence-based, in-person interventions would be difficult or cost-prohibitive.

  • Source: Flickr; Copyright: Joel Dinda; URL: https://www.flickr.com/photos/96739609@N00/33666011132; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    Electronic Swallowing Intervention Package to Support Swallowing Function in Patients With Head and Neck Cancer: Development and Feasibility Study

    Abstract:

    Background: Many patients undergoing treatment for head and neck cancer (HNC) experience significant swallowing difficulties, and there is some evidence that swallowing exercises may improve outcomes, including quality of life. This feasibility study developed an evidence-based, practical Swallowing Intervention Package (SiP) for patients undergoing chemoradiotherapy (CRT) for HNC. As part of the study, an electronic version of SiP (e-SiP) was concurrently developed to support patients to self-manage during treatment. This paper reports on the e-SiP component of this work. Objective: The objective of our study was to develop and conduct a preliminary evaluation of an electronic support system (e-SiP) for patients undergoing CRT for HNC. Methods: The study was conducted using a recognized mHealth development and evaluation framework and involved health professionals and patients who were undergoing CRT for HNC. The scoping stage of e-SiP development investigated the potential usefulness of the app, exploring how e-SiP would look and feel and what content would be appropriate to provide. Patient and carer focus groups and a health professionals’ consensus day were used as means of data gathering around potential e-SiP content. A repeat focus group looked at an outline version of e-SiP and informed the next stage of its development with regard to refining the requirements for the tool. This was followed by further development and a testing stage of e-SiP that involved the coding of a prototype, which was then evaluated using a series of steering group meetings, semistructured interviews with both patients and health care professionals, and analysis of e-SiP log data. Results: Feedback from focus groups and health professional interviews was very positive, and it was felt e-SiP use would support and encourage patients in conducting their swallowing exercises. However, of the 10 patients who were offered e-SiP, only 2 opted to use it. For these patients, the aspects of the e-SiP app were considered useful, in particular, the ease of keeping a diary of exercises performed. Interviews with users and nonusers suggested significant barriers to its use. Most significantly, the lack of flexibility of the platform on which e-SiP could be accessed appeared a dominant factor in deterring e-SiP use. Conclusions: The results suggest that further research needs to be conducted around the implementation of e-SiP. This involves evaluating how e-SiP can be better integrated into usual care and through patient training and staff engagement, can be perceived as a beneficial tool to help support patients in conducting swallowing exercises.

  • The PEPA concept (montage). Source: The Authors / Placeit.net; Copyright: The Authors; URL: http://formative.jmir.org/2018/2/e10411/; License: Licensed by the authors.

    Utilizing a Prototype Patient-Controlled Electronic Health Record in Germany: Qualitative Analysis of User-Reported Perceptions and Perspectives

    Abstract:

    Background: Personal electronic health records (PHR) are considered instrumental in improving health care quality and efficiency, enhancing communication between all parties involved and strengthening the patient’s role. Technical architectures, data privacy, and applicability issues have been discussed for many years. Nevertheless, nationwide implementation of a PHR is still pending in Germany despite legal regulations provided by the eHealth Act passed in 2015. Within the information technology for patient-oriented care project funded by the Federal Ministry of Education and Research (2012-2017), a Web-based personal electronic health record prototype (PEPA) was developed enabling patient-controlled information exchange across different care settings. Gastrointestinal cancer patients and general practitioners utilized PEPA during a 3-month trial period. Both patients and physicians authorized by them could view PEPA content online and upload or download files. Objective: This paper aims to outline findings of the posttrial qualitative study carried out to evaluate user-reported experiences, perceptions, and perspectives, focusing on their interpretation of PEPA beyond technical usability and views on a future nationwide implementation. Methods: Data were collected through semistructured guide-based interviews with 11 patients and 3 physicians (N=14). Participants were asked to share experiences, views of perceived implications, and perspectives towards nationwide implementation. Further data were generated through free-text fields in a subsequent study-specific patient questionnaire and researcher’s notes. Data were pseudonymized, audiotaped, and transcribed verbatim. Content analysis was performed through the Framework Analysis approach. All qualitative data were systemized by using MAXQDA Analytics PRO 12 (Rel.12.3.1). Additionally, participant characteristics were analyzed descriptively using IBM SPSS Statistics Version 24. Results: Users interpreted PEPA as a central medium containing digital chronological health-related documentation that simplifies information sharing across care settings. While patients consider the implementation of PEPA in Germany in the near future, physicians are more hesitant. Both groups believe in PEPA’s concept, but share awareness of concerns about data privacy and older or impaired people’s abilities to manage online records. Patients perceive benefits for involvement in treatment processes and continuity of care but worry about financing and the implementation of functionally reduced versions. Physicians consider integration into primary systems critical for interoperability but anticipate technical challenges, as well as resistance from older patients and colleagues. They omit clear positioning regarding PEPA’s potential incremental value for health care organizations or the provider-patient relationship. Conclusions: Digitalization in German health care will continue to bring change, both organizational and in the physician-patient relationship. Patients endorse and expect a nationwide PEPA implementation, anticipating various benefits. Decision makers and providers need to contribute to closing modernization gaps by committing to new concepts and by invigorating transformed roles.

  • Homepage of Transplant-TAVIE intervention (montage). Source: The Authors / Placeit.net; Copyright: JMIR Publications; URL: http://formative.jmir.org/2018/2/e14/; License: Creative Commons Attribution (CC-BY).

    Web-Based Tailored Intervention to Support Optimal Medication Adherence Among Kidney Transplant Recipients: Pilot Parallel-Group Randomized Controlled Trial

    Abstract:

    Background: Optimal immunosuppressive medication adherence is essential to graft survival. Transplant-TAVIE is a Web-based tailored intervention developed to promote this adherence. Objective: The objective of our study was to evaluate the Transplant-TAVIE intervention’s acceptability, feasibility, and preliminary efficacy. Methods: In a pilot, parallel-group, randomized controlled trial, we randomly assigned a convenience sample of 70 kidney transplant patients on immunosuppressive medication either to an experimental group (Transplant-TAVIE) or to a control group (existing websites). Kidney transplant recipients had to be older than 18 years, be taking immunosuppressant medication, and have access to the internet to participate in this study. Transplant-TAVIE was composed of three interactive Web-based sessions hosted by a virtual nurse. We documented user appreciation of and exposure to the intervention. Furthermore, we assessed medication adherence, medication self-efficacy, intake-related skills, and medication side effects at baseline and 3 and 6 months later. Analyses of variance were used to assess intergroup differences over time. Results: After baseline questionnaire completion, participants were randomly assigned either to Transplant-TAVIE (n=35) or to the websites (n=35) group. All participants had received their kidney graft <1 year to 32 years earlier (mean 6.8 years). Of the experimental group, 54% (19/35) completed the sessions of Transplant-TAVIE. Users found the intervention to be acceptable—33% were extremely satisfied (6/18), 39% were very satisfied (7/18), and 28% were satisfied (5/18). At baseline and over time, both experimental and control groups reported high medication adherence, high medication self-efficacy, and frequent use of skills related to medication intake. No intergroup differences emerged over time. Conclusions: The results of this study support the feasibility and acceptability of Transplant-TAVIE. It could constitute an accessible adjunct in support of existing specialized services.

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  • Web-based prescription opioid abuse prevention for adolescents: Program development and formative evaluation

    Date Submitted: Oct 2, 2018

    Open Peer Review Period: Oct 6, 2018 - Dec 1, 2018

    Background: Background: The unprecedented number of youth engaged in nonmedical use of prescription opioids (PO), as well as the myriad negative consequences of such misuse emphasize the importance of...

    Background: Background: The unprecedented number of youth engaged in nonmedical use of prescription opioids (PO), as well as the myriad negative consequences of such misuse emphasize the importance of prevention efforts targeting this public health crisis. Although there are several science-based, interactive, drug-abuse prevention programs focused on preventing use of non-prescription drugs in youth, to our knowledge, there are no science-based, interactive programs focused on the prevention of prescription opioid abuse among adolescents. Objective: Objectives: The aim of this study was to develop and conduct a formative evaluation of a science-based, interactive web-based program focused on the prevention of prescription opioid abuse among adolescents aged 12-17 (Pop4Teens.c4tbh.org). This work was conducted to prepare for a randomized, controlled trial designed to evaluate the effectiveness of Pop4Teens compared to an active control website, JustThinkTwice.com (Drug Enforcement Administration) in impacting knowledge and attitudes about prescription opioids, perceptions of risk associated with abuse of prescription opioids, as well as intentions to use and actual use of prescription opioids. Methods: Methods: We conducted six focus groups with 30 youth (M = 5/group: 12-19 years of age eligible) along a continuum of exposure to POs (in treatment for opioid use disorder, in general treatment for other substance use disorder, prescribed an opioid, and opioid naïve), and writing sessions with 30 youth in treatment for opioid use disorder (12-19) to inform the development of the web-based prevention tool. Feasibility and acceptability of a prototype of the web-based intervention were then assessed through individual feedback sessions with 57 youth (drawn from same populations as focus groups). Results: Results: We successfully completed the development of a web-based prescription opioid abuse prevention program (Pop4Teens). Analyses of focus group transcripts informed the development of the program (e.g., quiz content/format, script writing, story editing). Selected writing session narratives anchored the planned scientific content by lending credibility, as well as informing the development of compelling storylines intended to motivate youth to engage with the program. Feedback session data indicate that the web-based tool could be potentially useful and acceptable. Also, feedback session participants demonstrated significant increases in their knowledge of key topics related to the prevention of prescription opioid abuse after exposure to sections of the web-based program. Conclusions: Conclusions: The opioid crisis is predicted to get worse before it gets better. An effective response will likely require a multi-pronged strategy inclusive of effective evidence-based prevention programs acceptable to, and accessible by, a majority of youth. Clinical Trial: NA

  • Development and Feasibility of REAL media: An e-learning Adaption of an Evidence-based Media Literacy Curriculum to Prevent Youth Substance Use in Community Groups

    Date Submitted: Sep 6, 2018

    Open Peer Review Period: Sep 10, 2018 - Nov 5, 2018

    Background: There is a need for evidence-based substance use prevention efforts that target high school-aged youth that are easy to implement and suitable for dissemination in school and community gro...

    Background: There is a need for evidence-based substance use prevention efforts that target high school-aged youth that are easy to implement and suitable for dissemination in school and community groups. The Youth Message Development (YMD) program, a 4-lesson, in-person curriculum which develops media literacy and critical thinking skills among youth, has demonstrated evidence of success but is limited by its delivery method and focus on alcohol and smoking. Objective: To adapt the in-person YMD curriculum for youth ages 13-15 to a self-paced, interactive, e-learning format targeting several commonly used substances for implementation and dissemination in a national youth organization and subsequently test the feasibility of this approach. Methods: An iterative process was employed in partnership with the 4-H youth development organization and a technology developer and consisted of six phases: (1) focus groups with the target audience, (2) adaptation to e-learning format, renamed REAL media, (3) pilot testing, (4) program revisions, (5) usability testing, and (6) final revisions. Results: Focus group feedback guided the build of an e-learning prototype of REAL media, which consisted on five online levels and interactive content guided by a mix of narration and on-screen text. Results of a pilot test of the prototype were neutral to positive, and the program was refined based on end-user feedback. An independent usability test indicated that youth 4-H members felt favorably about navigating REAL media, and they reported high self-efficacy in applying skills learned in the program. Additional refinements to the program were made based upon their feedback. Conclusions: The iterative build process involving the end-user from the outset yielded an overall successful technology-driven adaptation of an evidence-based curriculum. This should increase the likelihood of effectively impacting behavioral outcomes as well as uptake within community organizations.

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