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Journal Description

JMIR Human Factors (JHF) is a PubMed-indexed, peer-reviewed sister journal of JMIR, a leading open access eHealth journal (Impact Factor 2017: 4.671).
 
JMIR Human Factors is a multidisciplinary journal with contributions from medical researchers, engineers, and social scientists.

JMIR Human Factors focuses on understanding how the behaviour and thinking of humans can influence and shape the design of health care interventions and technologies, and how the design can be evaluated and improved to make health care interventions and technologies usable, safe, and effective. JHF aspires to lead health care towards a culture of testing and safety by promoting and publishing reports rigorously evaluating the usability and human factors aspects in health care, as well as encouraging the development and debate on new methods in this emerging field. 

All articles are professionally copyedited and typeset, ready for indexing in PubMed/PubMed Central. Possible contributions include usability studies and heuristic evaluations, studies concerning ergonomics and error prevention, design studies for medical devices and healthcare systems/workflows, enhancing teamwork through Human Factors based teamwork training, measuring non-technical skills in staff like leadership, communication, situational awareness and teamwork, and healthcare policies and procedures to reduce errors and increase safety. Reviews, viewpoint papers and tutorials are as welcome as original research.

Editorial Board members are currently being recruited, please contact us if you are interested (jmir.editorial.office at gmail.com).

 
 
 
 

Recent Articles:

  • eHealth as support for chronic obstructive pulmonary disease–related self-management strategies. Source: Image created by the Authors; Copyright: Sara Lundell; URL: http://humanfactors.jmir.org/2018/4/e10801/; License: Creative Commons Attribution (CC-BY).

    Usefulness and Relevance of an eHealth Tool in Supporting the Self-Management of Chronic Obstructive Pulmonary Disease: Explorative Qualitative Study of a...

    Abstract:

    Background: New strategies are urgently needed to support self-management for people with chronic obstructive pulmonary disease (COPD) in primary care. The use of electronic health (eHealth) solutions is promising. However, there is a lack of knowledge about how such eHealth tools should be designed in order to be perceived as relevant and useful and meet the needs and expectations of the health professionals as well as people with COPD and their relatives. Objective: The objective of this study was to explore the aspects of an eHealth tool design and content that make it relevant and useful for supporting COPD-related self-management strategies from the perspective of health care professionals, people with COPD and their relatives, and external researchers. Methods: Data were collected during the development of an eHealth tool. A cocreation process was carried out with participants from two primary care units in northern Sweden and external researchers. Individual interviews were performed with health care professionals (n=13) as well as people with COPD (n=6) and their relatives (n=2), and focus group discussions (n=9) were held with all groups of participants. Data were analyzed using qualitative content analysis. Results: The overarching theme, reinforcing existing support structures, reflects participant views that the eHealth tool needs to be directly applicable and create a sense of commitment in users. Moreover, participants felt that the tool needs to fit with existing routines and contexts and preferably should not challenge existing hierarchies between health care professionals and people with COPD. Important content for health care professionals and people with COPD included knowledge about self-management strategies. Videos were regarded as the most effective method for communicating such knowledge. Conclusions: The cocreation in the development process enables participant perspectives and priorities to be built into the eHealth tool. This is assumed to contribute to a tool that is useful and relevant and, therefore, adopted into clinical practice and everyday life. Findings from this study can inform the development of eHealth tools for people with COPD in other contexts, as well as the development of eHealth tools for self-management support of other chronic diseases.

  • ICU monitoring. Source: Dreamstime; Copyright: Andrei Malov; URL: https://www.dreamstime.com/stock-photography-monitoring-icu-image2549142; License: Licensed by the authors.

    Alarm-Related Workload in Default and Modified Alarm Settings and the Relationship Between Alarm Workload, Alarm Response Rate, and Care Provider Experience:...

    Abstract:

    Background: Delayed or no response to impending patient safety–related calls, poor care provider experience, low job satisfaction, and adverse events are all unwanted outcomes of alarm fatigue. Nurses often cite increases in alarm-related workload as a reason for alarm fatigue, which is a major contributor to the aforementioned unwanted outcomes. Increased workload affects both the care provider and the patient. No studies to date have evaluated the workload while caring for patients and managing alarms simultaneously and related it to the primary measures of alarm fatigue—alarm response rate and care provider experience. Many studies have assessed the effect of modifying the default alarm setting; however, studies on the perceived workload under different alarm settings are limited. Objective: This study aimed to assess nurses’ or assistants’ perceived workload index of providing care under different clinical alarm settings and establish the relationship between perceived workload, alarm response rate, and care provider experience. Methods: In a clinical simulator, 30 participants responded to alarms that occurred on a physiological monitor under 2 conditions (default and modified) for a given clinical condition. Participants completed a National Aeronautics and Space Administration-Task Load Index questionnaire and rated the demand experienced on a 20-point visual analog scale with low and high ratings. A correlational analysis was performed to assess the relationships between the perceived workload score, alarm response rate, and care provider experience. Results: Participants experienced lower workloads when the clinical alarm threshold limits were modified according to patients’ clinical conditions. The workload index was higher for the default alarm setting (57.60 [SD 2.59]) than for the modified alarm setting (52.39 [SD 2.29]), with a statistically significant difference of 5.21 (95% CI 3.38-7.04), t28=5.838, P<.05. Significant correlations were found between the workload index and alarm response rate. There was a strong negative correlation between alarm response rate and perceived workload, ρ28=−.54, P<.001 with workload explaining 29% of the variation in alarm response rate. There was a moderate negative correlation between the experience reported during patient care and the perceived workload, ρ28=−.49, P<.05. Conclusions: The perceived workload index was comparatively lower with alarm settings modified for individual patient care than in an unmodified default clinical alarm setting. These findings demonstrate that the modification of clinical alarm limits positively affects the number of alarms accurately addressed, care providers’ experience, and overall satisfaction. The findings support the removal of nonessential alarms based on patient conditions, which can help care providers address the remaining alarms accurately and provide better patient care.

  • User with portal visualization. Source: Image created by the Authors; Copyright: Katherine Kim; URL: http://humanfactors.jmir.org/2018/4/e11826/; License: Creative Commons Attribution (CC-BY).

    Data Visualizations to Support Health Practitioners’ Provision of Personalized Care for Patients With Cancer and Multiple Chronic Conditions: User-Centered...

    Abstract:

    Background: There exists a challenge of understanding and integrating various types of data collected to support the health of individuals with multiple chronic conditions engaging in cancer care. Data visualization has the potential to address this challenge and support personalized cancer care. Objective: The aim of the study was to assess the health care practitioners’ perceptions of and feedback regarding visualizations developed to support the care of individuals with multiple chronic conditions engaging in cancer care. Methods: Medical doctors (n=4) and registered nurses (n=4) providing cancer care at an academic medical center in the western United States provided feedback on visualization mock-ups. Mock-up designs were guided by current health informatics and visualization literature and the Munzner Nested Model for Visualization Design. User-centered design methods, a mock patient persona, and a scenario were used to elicit insights from participants. Directed content analysis was used to identify themes from session transcripts. Means and SDs were calculated for health care practitioners’ rankings of overview visualizations. Results: Themes identified were data elements, supportive elements, confusing elements, interpretation, and use of visualization. Overall, participants found the visualizations useful and with the potential to provide personalized care. Use of color, reference lines, and familiar visual presentations (calendars, line graphs) were noted as helpful in interpreting data. Conclusions: Visualizations guided by a framework and literature can support health care practitioners’ understanding of data for individuals with multiple chronic conditions engaged in cancer care. This understanding has the potential to support the provision of personalized care.

  • Applying Persuasive Design Techniques to Influence Data-Entry Behaviors in Primary Care: Repeated Measures Evaluation Using Statistical Process Control

    Abstract:

    Background: Persuasive design is an approach that seeks to change the behaviors of users. In primary care, clinician behaviors and attitudes are important precursors to structured data entry, and there is an impact on overall data quality. We hypothesized that persuasive design changes data-entry behaviors in clinicians and thus improves data quality. Objective: The objective of this study was to use persuasive design principles to change clinician data-entry behaviors in a primary care environment and to increase data quality of data held in a family health team’s reporting system. Methods: We used the persuasive systems design framework to describe the persuasion context. Afterward, we designed and implemented new features into a summary screen that leveraged several persuasive design principles. We tested the influence of the new features by measuring its impact on 3 data quality measures (same-day entry, record completeness, and data validity). We also measured the impacts of the new features with a paired pre-post t test and generated XmR charts to contextualize the results. Survey responses were also collected from users. Results: A total of 53 users used the updated system that incorporated the new features over the course of 8 weeks. Based on a pre-post analysis, the new summary screen successfully encouraged users to enter more of their data on the same day as their encounter. On average, the percentage of same-day entries rose by 10.3% for each user (P<.001). During the first month of the postimplementation period, users compensated by sacrificing aspects of data completeness before returning to normal in the second month. Improvements to record validity were marginal over the study period (P=.05). Statistical process control techniques allowed us to study the XmR charts to contextualize our results and understand trends throughout the study period. Conclusions: By conducting a detailed systems analysis and introducing new persuasive design elements into a data-entry system, we demonstrated that it was possible to change data-entry behavior and influence data quality in a reporting system. The results show that using persuasive design concepts may be effective in influencing data-entry behaviors in clinicians. There may be opportunities to continue improving this approach, and further work is required to perfect and test additional designs. Persuasive design is a viable approach to encourage clinician user change and could support better data capture in the field of medical informatics.

  • Source: Dreamstime; Copyright: Wavebreakmedia Ltd; URL: https://www.dreamstime.com/stock-photo-mid-section-pregnant-woman-touching-belly-holding-mobile-phone-image60548550; License: Licensed by the authors.

    Developing Culturally Sensitive mHealth Apps for Caribbean Immigrant Women to Use During Pregnancy: Focus Group Study

    Authors List:

    Abstract:

    Background: A valuable addition to the mobile health (mHealth) space is an exploration of the context of minorities in developed countries. The transition period postmigration, culture, and socioeconomic uniqueness of migratory groups can shed light on the problems with existing prenatal mHealth apps. Objective: The objectives of this study were to (1) use the theoretical concept of pregnancy ecology to understand the emotional, physical, information, and social challenges affecting low-income Caribbean immigrant women’s prenatal well-being practices and (2) develop a deep understanding of challenges worthy of consideration in mHealth design for these women. Methods: This qualitative interpretive approach using analytical induction presents the findings of 3 focus group sessions with 12 Caribbean immigrant women living in South Florida in the United States. The study took place from April to September 2015. Results: The participants revealed problematic tiers and support needs within the pregnancy ecology including emotional stressors caused by family separation, physical challenges, information gaps, and longing for social support. Conclusions: mHealth interventions for low-income Caribbean immigrant women must be designed beyond the conventional way of focusing on the events surrounding the unborn child. It can be tailored to the needs of the expecting mother. Pregnancy information should be customized on the basis of the variability of lifestyle, cultural practices, socioeconomic status, and social ties while still being able to deliver appropriate guidelines and clear cultural misconceptions.

  • Source: The Authors; Copyright: The Authors; URL: http://humanfactors.jmir.org/2018/4/e27/; License: Licensed by JMIR.

    Collecting Health and Exposure Data in Australian Olympic Combat Sports: Feasibility Study Utilizing an Electronic System

    Abstract:

    Background: Electronic methods are increasingly being used to manage health-related data among sporting populations. Collection of such data permits the analysis of injury and illness trends, improves early detection of injuries and illnesses, collectively referred to as health problems, and provides evidence to inform prevention strategies. The Athlete Management System (AMS) has been employed across a range of sports to monitor health. Australian combat athletes train across the country without dedicated national medical or sports science teams to monitor and advocate for their health. Employing a Web-based system, such as the AMS, may provide an avenue to increase the visibility of health problems experienced by combat athletes and deliver key information to stakeholders detailing where prevention programs may be targeted. Objective: The objectives of this paper are to (1) report on the feasibility of utilizing the AMS to collect longitudinal injury and illness data of combat sports athletes and (2) describe the type, location, severity, and recurrence of injuries and illnesses that the cohort of athletes experience across a 12-week period. Methods: We invited 26 elite and developing athletes from 4 Olympic combat sports (boxing, judo, taekwondo, and wrestling) to participate in this study. Engagement with the AMS was measured, and collected health problems (injuries or illnesses) were coded using the Orchard Sports Injury Classification System (version 10.1) and International Classification of Primary Care (version 2). Results: Despite >160 contacts, athlete engagement with online tools was poor, with only 13% compliance across the 12-week period. No taekwondo or wrestling athletes were compliant. Despite low overall engagement, a large number of injuries or illness were recorded across 11 athletes who entered data—22 unique injuries, 8 unique illnesses, 30 recurrent injuries, and 2 recurrent illnesses. The most frequent injuries were to the knee in boxing (n=41) and thigh in judo (n=9). In this cohort, judo players experienced more severe, but less frequent, injuries than boxers, yet judo players sustained more illnesses than boxers. In 97.0% (126/130) of cases, athletes in this cohort continued to train irrespective of their health problems. Conclusions: Among athletes who reported injuries, many reported multiple conditions, indicating a need for health monitoring in Australian combat sports. A number of factors may have influenced engagement with the AMS, including access to the internet, the design of the system, coach views on the system, previous experiences with the system, and the existing culture within Australian combat sports. To increase engagement, there may be a requirement for sports staff to provide relevant feedback on data entered into the system. Until the barriers are addressed, it is not feasible to implement the system in its current form across a larger cohort of combat athletes.

  • Source: Freepik; Copyright: Pressfoto; URL: https://www.freepik.com/free-photo/doctor-looking-for-information-in-the-database_863249.htm#term=doctor%20typing&page=1&position=2; License: Licensed by JMIR.

    Clinically Excellent Use of the Electronic Health Record: Review

    Abstract:

    Background: The transition to the electronic health record (EHR) has brought forth a rapid cultural shift in the world of medicine, presenting both new challenges as well as opportunities for improving health care. As clinicians work to adapt to the changes imposed by the EHR, identification of best practices around the clinically excellent use of the EHR is needed. Objective: Using the domains of clinical excellence previously defined by the Johns Hopkins Miller Coulson Academy of Clinical Excellence, this review aims to identify best practices around the clinically excellent use of the EHR. Methods: The authors searched the PubMed database, using keywords related to clinical excellence domains and the EHR, to capture the English-language, peer-reviewed literature published between January 1, 2000, and August 2, 2016. One author independently reviewed each article and extracted relevant data. Results: The search identified 606 titles, with the majority (393/606, 64.9%) in the domain of communication and interpersonal skills. Twenty-eight of the 606 (4.6%) titles were excluded from full-text review, primarily due to lack of availability of the full-text article. The remaining 578 full-text articles reviewed were related to clinical excellence generally (3/578, 0.5%) or the specific domains of communication and interpersonal skills (380/578, 65.7%), diagnostic acumen (31/578, 5.4%), skillful negotiation of the health care system (4/578, 0.7%), scholarly approach to clinical practice (41/578, 7.1%), professionalism and humanism (2/578, 0.4%), knowledge (97/578, 16.8%), and passion for clinical medicine (20/578, 3.5%). Conclusions: Results suggest that as familiarity and expertise are developed, clinicians are leveraging the EHR to provide clinically excellent care. Best practices identified included deliberate physical configuration of the clinical space to involve sharing the screen with patients and limiting EHR use during difficult and emotional topics. Promising horizons for the EHR include the ability to augment participation in pragmatic trials, identify adverse drug effects, correlate genomic data to clinical outcomes, and follow data-driven guidelines. Clinician and patient satisfaction with the EHR has generally improved with time, and hopefully continued clinician, and patient input will lead to a system that satisfies all.

  • Group coding. Source: The Authors; Copyright: The Authors; URL: http://humanfactors.jmir.org/2018/3/e24; License: Creative Commons Attribution + Noncommercial (CC-BY-NC).

    Physician and Pharmacist Medication Decision-Making in the Time of Electronic Health Records: Mixed-Methods Study 

    Abstract:

    Background: Primary care needs to be patient-centered, integrated, and interprofessional to help patients with complex needs manage the burden of medication-related problems. Considering the growing problem of polypharmacy, increasing attention has been paid to how and when medication-related decisions should be coordinated across multidisciplinary care teams. Improved knowledge on how integrated electronic health records (EHRs) can support interprofessional shared decision-making for medication therapy management is necessary to continue improving patient care. Objective: The objective of our study was to examine how physicians and pharmacists understand and communicate patient-focused medication information with each other and how this knowledge can influence the design of EHRs. Methods: This study is part of a broader cross-Canada study between patients and health care providers around how medication-related decisions are made and communicated. We visited community pharmacies, team-based primary care clinics, and independent-practice family physician clinics throughout Ontario, Nova Scotia, Alberta, and Quebec. Research assistants conducted semistructured interviews with physicians and pharmacists. A modified version of the Multidisciplinary Framework Method was used to analyze the data. Results: We collected data from 19 pharmacies and 9 medical clinics and identified 6 main themes from 34 health care professionals. First, Interprofessional Shared Decision-Making was not occurring and clinicians made decisions based on their understanding of the patient. Physicians and pharmacists reported indirect Communication, incomplete Information specifically missing insight into indication and adherence, and misaligned Processes of Care that were further compounded by EHRs that are not designed to facilitate collaboration. Scope of Practice examined professional and workplace boundaries for pharmacists and physicians that were internally and externally imposed. Physicians decided on the degree of the Physician-Pharmacist Relationship, often predicated by colocation. Conclusions: We observed limited communication and collaboration between primary care providers and pharmacists when managing medications. Pharmacists were missing key information around reason for use, and physicians required accurate information around adherence. EHRs are a potential tool to help clinicians communicate information to resolve this issue. EHRs need to be designed to facilitate interprofessional medication management so that pharmacists and physicians can move beyond task-based work toward a collaborative approach.

  • Human-Centered Design Workshop. Source: Flickr.com; Copyright: Nearsoft Inc; URL: https://www.flickr.com/photos/nearsoft/14412062291/in/photolist-22b95gi-cJa5Z9-cZRgcf-qhv7S4-kY3Hr-nXxA1B-7zCVQw-a7LAUb-UQEkeJ-kY3ib-ekBmet-8rucyj-cJa78d-55HY3r-dibasY-9gZfX-q22SWK-nAM2fD-6uGoJg-55Nc3Q-62iuRr-zX1YBu-z3hG93-Znf4dV-Znf8Ax-8Ysxmx-cJa6m3-Cg2L; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    A Patient-Facing Diabetes Dashboard Embedded in a Patient Web Portal: Design Sprint and Usability Testing

    Abstract:

    Background: Health apps and Web-based interventions designed for patients with diabetes offer novel and scalable approaches to engage patients and improve outcomes. However, careful attention to the design and usability of these apps and Web-based interventions is essential to reduce the barriers to engagement and maximize use. Objective: The aim of this study was to apply design sprint methodology paired with mixed-methods, task-based usability testing to design and evaluate an innovative, patient-facing diabetes dashboard embedded in an existing patient portal and integrated into an electronic health record. Methods: We applied a 5-day design sprint methodology developed by Google Ventures (Alphabet Inc, Mountain View, CA) to create our initial dashboard prototype. We identified recommended strategies from the literature for using patient-facing technologies to enhance patient activation and designed a dashboard functionality to match each strategy. We then conducted a mixed-methods, task-based usability assessment of dashboard prototypes with individual patients. Measures included validated metrics of task performance on 5 common and standardized tasks, semistructured interviews, and a validated usability satisfaction questionnaire. After each round of usability testing, we revised the dashboard prototype in response to usability findings before the next round of testing until the majority of participants successfully completed tasks, expressed high satisfaction, and identified no new usability concerns (ie, stop criterion was met). Results: The sample (N=14) comprised 5 patients in round 1, 3 patients in round 2, and 6 patients in round 3, at which point we reached our stop criterion. The participants’ mean age was 63 years (range 45-78 years), 57% (8/14) were female, and 50% (7/14) were white. Our design sprint yielded an initial patient-facing diabetes dashboard prototype that displayed and summarized 5 measures of patients’ diabetes health status (eg, hemoglobin A1c). The dashboard used graphics to visualize and summarize health data and reinforce understanding, incorporated motivational strategies (eg, social comparisons and gamification), and provided educational resources and secure-messaging capability. More than 80% of participants were able to successfully complete all 5 tasks using the final prototype. Interviews revealed usability concerns with design, the efficiency of use, and content and terminology, which led to improvements. Overall satisfaction (0=worst and 7=best) improved from the initial to the final prototype (mean 5.8, SD 0.4 vs mean 6.7, SD 0.5). Conclusions: Our results demonstrate the utility of the design sprint methodology paired with mixed-methods, task-based usability testing to efficiently and effectively design a patient-facing, Web-based diabetes dashboard that is satisfying for patients to use.

  • Source: Pixabay; Copyright: Free-Photos; URL: https://pixabay.com/en/computer-business-typing-keyboard-1149148/; License: Public Domain (CC0).

    Designing Emails Aimed at Increasing Family Physicians’ Use of a Web-Based Audit and Feedback Tool to Improve Cancer Screening Rates: Cocreation Process

    Abstract:

    Background: Providing clinical performance data to health professionals, a process known as audit and feedback, can play an important role in health system improvement. However, audit and feedback tools can only be effective if the targeted health professionals access and actively review their data. Email is used by Cancer Care Ontario, a provincial cancer agency, to promote access to a Web-based audit and feedback tool called the Screening Activity Report (SAR); however, current emails that lack behavior change content have been ineffective at encouraging log-in to the SAR. Objective: The objective of our study was to describe the process and experience of developing email content that incorporates user input and behavior change techniques (BCTs) to promote the use of the SAR among Ontario primary care providers. Methods: Our interdisciplinary research team first identified BCTs shown to be effective in other settings that could be adapted to promote use of the SAR. We then developed draft BCT-informed email content. Next, we conducted cocreation workshops with physicians who had logged in to the SAR more than once over the past year. Participants provided reactions to researcher-developed BCT-informed content and helped to develop an email that they believed would prompt their colleagues to use the SAR. Content from cocreation workshops was brought to focus groups with physicians who had not used the SAR in the past year. We analyzed notes from the cocreation workshops and focus groups to inform decisions about content. Finally, 8 emails were created to test BCT-informed content in a 2×2×2 factorial randomized experiment. Results: We identified 3 key tensions during the development of the email that required us to balance user input with scientific evidence, organizational policies, and our scientific objectives, which are as follows: conflict between user preference and scientific evidence, privacy constraints around personalizing unencrypted emails with performance data, and using cocreation methods in a study with the objective of developing an email that featured BCT-informed content. Conclusions: Teams tasked with developing content to promote health professional engagement with audit and feedback or other quality improvement tools might consider cocreation processes for developing communications that are informed by both users and BCTs. Teams should be cautious about making decisions solely based on user reactions because what users seem to prefer is not always the same as what works. Furthermore, implementing user recommendations may not always be feasible. Teams may face challenges when using cocreation methods to develop a product with the simultaneous goal of having clearly defined variables to test in later studies. The expected role of users, evidence, and the implementation context all warrant consideration to determine whether and how cocreation methods could help to achieve design and scientific objectives.

  • The D2Refine usability study meticulously captured experiences and feedback from study participants for computing precise quantitative results. Source: Image created by the Authors; Copyright: The Authors; URL: http://humanfactors.jmir.org/2018/3/e10205/; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    The D2Refine Platform for the Standardization of Clinical Research Study Data Dictionaries: Usability Study

    Abstract:

    Background: D2Refine provides a Web-based environment to create clinical research study data dictionaries and enables standardization and harmonization of its variable definitions with controlled terminology resources. Objective: To assess the usability of the functions D2Refine offers, a usability study was designed and executed. Methods: We employed the TURF (task, user, representation, and function) Usability Framework of electronic health record usability to design, configure, and execute the usability study and performed quantitative analyses. D2Refine was compared for its usability metrics against two other comparable solutions, OntoMaton and RightField, which have very similar functionalities for creating, managing, and standardizing data dictionaries. We first conducted the function analysis by conducting one-on-one interviews armed with questionnaires to catalog expected functionality. The enrolled participants carried out the steps for selected tasks to accomplish specific goals and their feedback was captured to conduct the task analysis. Results: We enrolled a group (n=27) of study developers, managers, and software professionals to execute steps of analysis as specified by the TURF framework. For the within-model domain function saturation, D2Refine had 96% saturation, which was 4 percentage points better than OntoMaton and 28 percentage points better than RightField. The manual examination and statistical analysis of the data were conducted for task analysis, and the results demonstrated a significant difference for favorability toward D2Refine (P<.001) with a 95% CI. Overall, 17 out of 27 (63%) participants indicated that D2Refine was their favorite of the three options. Conclusions: D2Refine is a useful and promising platform that can help address the emerging needs related to clinical research study data dictionary standardization and harmonization.

  • A patient completes the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) survey. Source: Image created by the Authors; Copyright: The Authors; URL: http://humanfactors.jmir.org/2018/3/e10070/; License: Licensed by JMIR.

    Software for Administering the National Cancer Institute’s Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events:...

    Abstract:

    Background: The US National Cancer Institute (NCI) developed software to gather symptomatic adverse events directly from patients participating in clinical trials. The software administers surveys to patients using items from the Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) through Web-based or automated telephone interfaces and facilitates the management of survey administration and the resultant data by professionals (clinicians and research associates). Objective: The purpose of this study was to iteratively evaluate and improve the usability of the PRO-CTCAE software. Methods: Heuristic evaluation of the software functionality was followed by semiscripted, think-aloud protocols in two consecutive rounds of usability testing among patients with cancer, clinicians, and research associates at 3 cancer centers. We conducted testing with patients both in clinics and at home (remotely) for both Web-based and telephone interfaces. Furthermore, we refined the software between rounds and retested. Results: Heuristic evaluation identified deviations from the best practices across 10 standardized categories, which informed initial software improvement. Subsequently, we conducted user-based testing among 169 patients and 47 professionals. Software modifications between rounds addressed identified issues, including difficulty using radio buttons, absence of survey progress indicators, and login problems (for patients) as well as scheduling of patient surveys (for professionals). The initial System Usability Scale (SUS) score for the patient Web-based interface was 86 and 82 (P=.22) before and after modifications, respectively, whereas the task completion score was 4.47, which improved to 4.58 (P=.39) after modifications. Following modifications for professional users, the SUS scores improved from 71 to 75 (P=.47), and the mean task performance improved significantly (4.40 vs 4.02; P=.001). Conclusions: Software modifications, informed by rigorous assessment, rendered a usable system, which is currently used in multiple NCI-sponsored multicenter cancer clinical trials. Trial Registration: ClinicalTrials.gov NCT01031641; https://clinicaltrials.gov/ct2/show/NCT01031641 (Archived by WebCite at http://www.webcitation.org/708hTjlTl)

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  • Evaluating the feasibility of a software prototype supporting the management of multi-morbid seniors: a mixed-methods study in general practices

    Date Submitted: Nov 5, 2018

    Open Peer Review Period: Nov 9, 2018 - Nov 23, 2018

    Background: Longitudinal, patient-centered care represents a challenge for general practices. Decision support and reminder systems can offer targeted support. Objective: Following a user-oriented, st...

    Background: Longitudinal, patient-centered care represents a challenge for general practices. Decision support and reminder systems can offer targeted support. Objective: Following a user-oriented, step-wise approach, we developed an add-on for German electronic health record (EHR) systems which aims to support longitudinal care management of multi-morbid seniors using a visualization strategy. This study evaluated the prototype’s feasibility from both a technical and users’ perspective. Methods: The study was conducted with 18 general practitioners (GP) and practice assistants (PA) from nine general practices using a mixed-methods approach. In all practices, one GP and one PA tested the software each for four multi-morbid seniors. Technical feasibility was evaluated by documenting all technical problems. To evaluate the feasibility from the users’ perspective, participants’ responses during the software test were documented. Also, they completed a self-administered questionnaire including the validated system usability scale (SUS). Data were merged by transforming qualitative data into quantitative data. Analyses were performed using univariate statistics in IBM SPSS statistics. Results: From a technical perspective, the new software was easy to install and worked without problems. Difficulties during the installation occurred in practices lacking a 64-bit system and/or a current version of Microsoft.Net. Because EHRs used in German practices do not provide an interface to extract the data needed, additional software was required. Incomplete visualization of some laboratory data occurred although this function was implemented in our software as shown in previous tests. From the users’ perspective, the new add-on provided a better overview of relevant patient information, reminded more comprehensively about upcoming examinations, and better supported guideline-based care when compared to their practice-individual strategies. Fourteen participants (77.7%) were interested in using the software long-term. Eight of nine GPs were willing to pay 5 to 25 Euros monthly for its use (14.75±5.93). The usability was rated as 75.3% (42.5%-95.0%). Conclusions: The new EHR add-on was well accepted and achieved a high usability measured by the validated SUS. Perspectively, the legally consolidated, standardized interface to German EHRs will facilitate the technical integration. In view of the high feasibility, we plan to study the software’s effectiveness in everyday primary care. Clinical Trial: German Clinical Trials Register, unique identifying number: DRKS00008777 (date of registration: 06/19/2015)

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