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Journal Description

The Journal of Medical Internet Research (JMIR), now in its 20th year, is the pioneer open access eHealth journal and is the flagship journal of JMIR Publications. It is the leading digital health journal globally in terms of quality/visibility (Impact Factor 2017: 4.671, ranked #1 out of 22 journals) and in terms of size (number of papers published). The journal focuses on emerging technologies, medical devices, apps, engineering, and informatics applications for patient education, prevention, population health and clinical care. As leading high-impact journal in its' disciplines (health informatics and health services research), it is selective, but it is now complemented by almost 30 specialty JMIR sister journals, which have a broader scope. Peer-review reports are portable across JMIR journals and papers can be transferred, so authors save time by not having to resubmit a paper to different journals. 

As open access journal, we are read by clinicians, allied health professionals, informal caregivers, and patients alike, and have (as all JMIR journals) a focus on readable and applied science reporting the design and evaluation of health innovations and emerging technologies. We publish original research, viewpoints, and reviews (both literature reviews and medical device/technology/app reviews).

We are also a leader in participatory and open science approaches, and offer the option to publish new submissions immediately as preprints, which receive DOIs for immediate citation (eg, in grant proposals), and for open peer-review purposes. We also invite patients to participate (eg, as peer-reviewers) and have patient representatives on editorial boards.

Be a widely cited leader in the digitial health revolution and submit your paper today!

 

Recent Articles:

  • Source: Image created by the Authors; Copyright: The Authors; URL: http://www.jmir.org/2019/5/e13868; License: Creative Commons Attribution (CC-BY).

    Digital Education of Health Professionals on the Management of Domestic Violence: Systematic Review and Meta-Analysis by the Digital Health Education...

    Abstract:

    Background: The World Health Organization states that 35% of women experience domestic violence at least once during their lifetimes. However, approximately 80% of health professionals have never received any training on management of this major public health concern. Objective: The objective of this study was to evaluate the effectiveness of health professions digital education on domestic violence compared to that of traditional ways or no intervention. Methods: Seven electronic databases were searched for randomized controlled trials from January 1990 to August 2017. The Cochrane Handbook guideline was followed, and studies reporting the use of digital education interventions to educate health professionals on domestic violence management were included. Results: Six studies with 631 participants met our inclusion criteria. Meta-analysis of 5 studies showed that as compared to control conditions, digital education may improve knowledge (510 participants and 5 studies; standardized mean difference [SMD] 0.67, 95% CI 0.38-0.95; I2=59%; low certainty evidence), attitudes (339 participants and 3 studies; SMD 0.67, 95% CI 0.25-1.09; I2=68%; low certainty evidence), and self-efficacy (174 participants and 3 studies; SMD 0.47, 95% CI 0.16-0.77; I2=0%; moderate certainty evidence). Conclusions: Evidence of the effectiveness of digital education on health professionals’ understanding of domestic violence is promising. However, the certainty of the evidence is predominantly low and merits further research. Given the opportunity of scaled transformative digital education, both further research and implementation within an evaluative context should be prioritized.

  • Source: Freepik; Copyright: Freepik; URL: https://www.freepik.com/free-photo/elderly-businessman-working-while-having-coffee_4203751.htm; License: Licensed by JMIR.

    A Novel Instrument for Measuring Older People’s Attitudes Toward Technology (TechPH): Development and Validation

    Abstract:

    Background: The use of health technology by older people is coming increasingly in focus with the demographic changes. Health information technology is generally perceived as an important factor in enabling increased quality of life and reducing the cost of care for this group. Age-appropriate design and facilitation of technology adoption are important to ensure functionality and removal of various barriers to usage. Development of assessment tools and instruments for evaluating older persons’ technology adoption and usage as well as measuring the effects of the interventions are of high priority. Both usability and acceptance of a specific technology or service are important factors in evaluating the impact of a health information technology intervention. Psychometric measures are seldom included in evaluations of health technology. However, basic attitudes and sentiments toward technology (eg, technophilia) could be argued to influence both the level of satisfaction with the technology itself as well as the perception of the health intervention outcome. Objective: The purpose of this study is to develop a reduced and refined instrument for measuring older people's attitudes and enthusiasm for technology based on relevant existing instruments for measuring technophilia. A requirement of the new instrument is that it should be short and simple to make it usable for evaluation of health technology for older people. Methods: Initial items for the TechPH questionnaire were drawn from a content analysis of relevant existing technophilia measure instruments. An exploratory factor analysis was conducted in a random selection of persons aged 65 years or older (N=374) on eight initial items. The scale was reduced to six items, and the internal consistency and reliability of the scale were examined. Further validation was made by a confirmatory factor analysis (CFA). Results: The exploratory factor analysis resulted in two factors. These factors were analyzed and labeled techEnthusiasm and techAnxiety. They demonstrated relatively good internal consistency (Cronbach alpha=.72 and .68, respectively). The factors were confirmed in the CFA and showed good model fit (χ28=21.2, χ2/df=2.65, comparative fit index=0.97, adjusted goodness-of-fit index=0.95, root mean square error of approximation=0.067, standardized root mean square residual=0.036). Conclusions: The construed TechPH score showed expected relations to external real-world criteria, and the two factors showed interesting internal relations. Different technophilia personality traits distinguish clusters with different behaviors of adaptation as well as usage of new technology. Whether there is an independent association with the TechPH score against outcomes in health technology projects needs to be shown in further studies. The instrument must also be validated in different contexts, such as other countries.

  • Source: The Authors / Placeit; Copyright: JMIR Publications; URL: http://www.jmir.org/2019/5/e13668/; License: Creative Commons Attribution (CC-BY).

    Validity of Online Screening for Autism: Crowdsourcing Study Comparing Paid and Unpaid Diagnostic Tasks

    Abstract:

    Background: Obtaining a diagnosis of neuropsychiatric disorders such as autism requires long waiting times that can exceed a year and can be prohibitively expensive. Crowdsourcing approaches may provide a scalable alternative that can accelerate general access to care and permit underserved populations to obtain an accurate diagnosis. Objective: We aimed to perform a series of studies to explore whether paid crowd workers on Amazon Mechanical Turk (AMT) and citizen crowd workers on a public website shared on social media can provide accurate online detection of autism, conducted via crowdsourced ratings of short home video clips. Methods: Three online studies were performed: (1) a paid crowdsourcing task on AMT (N=54) where crowd workers were asked to classify 10 short video clips of children as “Autism” or “Not autism,” (2) a more complex paid crowdsourcing task (N=27) with only those raters who correctly rated ≥8 of the 10 videos during the first study, and (3) a public unpaid study (N=115) identical to the first study. Results: For Study 1, the mean score of the participants who completed all questions was 7.50/10 (SD 1.46). When only analyzing the workers who scored ≥8/10 (n=27/54), there was a weak negative correlation between the time spent rating the videos and the sensitivity (ρ=–0.44, P=.02). For Study 2, the mean score of the participants rating new videos was 6.76/10 (SD 0.59). The average deviation between the crowdsourced answers and gold standard ratings provided by two expert clinical research coordinators was 0.56, with an SD of 0.51 (maximum possible SD is 3). All paid crowd workers who scored 8/10 in Study 1 either expressed enjoyment in performing the task in Study 2 or provided no negative comments. For Study 3, the mean score of the participants who completed all questions was 6.67/10 (SD 1.61). There were weak correlations between age and score (r=0.22, P=.014), age and sensitivity (r=–0.19, P=.04), number of family members with autism and sensitivity (r=–0.195, P=.04), and number of family members with autism and precision (r=–0.203, P=.03). A two-tailed t test between the scores of the paid workers in Study 1 and the unpaid workers in Study 3 showed a significant difference (P<.001). Conclusions: Many paid crowd workers on AMT enjoyed answering screening questions from videos, suggesting higher intrinsic motivation to make quality assessments. Paid crowdsourcing provides promising screening assessments of pediatric autism with an average deviation <20% from professional gold standard raters, which is potentially a clinically informative estimate for parents. Parents of children with autism likely overfit their intuition to their own affected child. This work provides preliminary demographic data on raters who may have higher ability to recognize and measure features of autism across its wide range of phenotypic manifestations.

  • Ethics of participatory disease surveillance. Source: Image created by the Authors; Copyright: The Authors; URL: https://www.jmir.org/2019/5/e12273/; License: Creative Commons Attribution (CC-BY).

    Participatory Disease Surveillance Systems: Ethical Framework

    Abstract:

    Advances in information technology are changing public health at an unprecedented rate. Participatory surveillance systems are contributing to public health by actively engaging digital (eg, Web-based) communities of volunteer citizens to report symptoms and other pertinent information on public health threats and also by empowering individuals to promptly respond to them. However, this digital model raises ethical issues on top of those inherent in traditional forms of public health surveillance. Research ethics are undergoing significant changes in the digital era where not only participants’ physical and psychological well-being but also the protection of their sensitive data have to be considered. In this paper, the digital platform of Influenzanet is used as a case study to illustrate those ethical challenges posed to participatory surveillance systems using digital platforms and mobile apps. These ethical challenges include the implementation of electronic consent, the protection of participants’ privacy, the promotion of justice, and the need for interdisciplinary capacity building of research ethics committees. On the basis of our analysis, we propose a framework to regulate and strengthen ethical approaches in the field of digital public health surveillance.

  • Source: Freepik; Copyright: jcomp; URL: https://www.freepik.com/free-photo/doctor-is-working-with-tablet-white-background_3763235.htm#index=44; License: Licensed by JMIR.

    Data Challenges With Real-Time Safety Event Detection And Clinical Decision Support

    Abstract:

    Background: The continued digitization and maturation of health care information technology has made access to real-time data easier and feasible for more health care organizations. With this increased availability, the promise of using data to algorithmically detect health care–related events in real-time has become more of a reality. However, as more researchers and clinicians utilize real-time data delivery capabilities, it has become apparent that simply gaining access to the data is not a panacea, and some unique data challenges have emerged to the forefront in the process. Objective: The aim of this viewpoint was to highlight some of the challenges that are germane to real-time processing of health care system–generated data and the accurate interpretation of the results. Methods: Distinct challenges related to the use and processing of real-time data for safety event detection were compiled and reported by several informatics and clinical experts at a quaternary pediatric academic institution. The challenges were collated from the experiences of the researchers implementing real-time event detection on more than half a dozen distinct projects. The challenges have been presented in a challenge category-specific challenge-example format. Results: In total, 8 major types of challenge categories were reported, with 13 specific challenges and 9 specific examples detailed to provide a context for the challenges. The examples reported are anchored to a specific project using medication order, medication administration record, and smart infusion pump data to detect discrepancies and errors between the 3 datasets. Conclusions: The use of real-time data to drive safety event detection and clinical decision support is extremely powerful, but it presents its own set of challenges that include data quality and technical complexity. These challenges must be recognized and accommodated for if the full promise of accurate, real-time safety event clinical decision support is to be realized.

  • Source: Image created by the Authors; Copyright: The Authors; URL: https://www.jmir.org/2019/5/e13131; License: Creative Commons Attribution (CC-BY).

    Perspectives of English, Chinese, and Spanish-Speaking Safety-Net Patients on Clinician Computer Use: Qualitative Analysis

    Abstract:

    Background: Safety-net systems serve patients with limited health literacy and limited English proficiency (LEP) who face communication barriers. However, little is known about how diverse safety-net patients feel about increasing clinician electronic health record (EHR) use. Objective: The aim of this study was to better understand how safety-net patients, including those with LEP, view clinician EHR use. Methods: We conducted focus groups in English, Spanish, and Cantonese (N=37) to elicit patient perspectives on how clinicians use EHRs during clinic visits. Using a grounded theory approach, we coded transcripts to identify key themes. Results: Across multiple language groups, participants accepted multitasking and silent clinician EHR use if focused on their care. However, participants desired more screen share and eye contact, especially when demonstrating physical concerns. All participants, including LEP participants, wanted clinicians to include them in EHR use. Conclusions: Linguistically diverse patients accept the value of EHR use during outpatient visits but desire more eye contact, verbal warnings before EHR use, and screen-sharing. Safety-net health systems should support clinicians in completing EHR-related tasks during the visit using patient-centered strategies for all patients.

  • Source: Flickr; Copyright: EdTech Stanford University School of Medicine; URL: https://www.flickr.com/photos/stanfordedtech/8034110512/in/album-72157631646125281/; License: Creative Commons Attribution + Noncommercial + NoDerivatives (CC-BY-NC-ND).

    Theories Predicting End-User Acceptance of Telemedicine Use: Systematic Review

    Abstract:

    Background: Only a few telemedicine applications have made their way into regular care. One reason is the lack of acceptance of telemedicine by potential end users. Objective: The aim of this systematic review was to identify theoretical predictors that influence the acceptance of telemedicine. Methods: An electronic search was conducted in PubMed and PsycINFO in June 2018 and supplemented by a hand search. Articles were identified using predefined inclusion and exclusion criteria. In total, two reviewers independently assessed the title, abstract, and full-text screening and then individually performed a quality assessment of all included studies. Results: Out of 5917 potentially relevant titles (duplicates excluded), 24 studies were included. The Axis Tool for quality assessment of cross-sectional studies revealed a high risk of bias for all studies except for one study. The most commonly used models were the Technology Acceptance Model (n=11) and the Unified Theory of Acceptance and Use of Technology (n=9). The main significant predictors of acceptance were perceived usefulness (n=11), social influences (n=6), and attitude (n=6). The results show a superiority of technology acceptance versus original behavioral models. Conclusions: The main finding of this review is the applicability of technology acceptance models and theories on telemedicine adoption. Characteristics of the technology, such as its usefulness, as well as attributes of the individual, such as his or her need for social support, inform end-user acceptance. Therefore, in the future, requirements of the target group and the group’s social environment should already be taken into account when planning telemedicine applications. The results support the importance of theory-guided user-centered design approaches to telemedicine development.

  • Source: Flickr; Copyright: Army Medicine; URL: https://www.flickr.com/photos/armymedicine/8643039512; License: Creative Commons Attribution (CC-BY).

    Health Data Processes: A Framework for Analyzing and Discussing Efficient Use and Reuse of Health Data With a Focus on Patient-Reported Outcome Measures

    Abstract:

    The collection and use of patient health data are central to any kind of activity in the health care system. These data may be produced during routine clinical processes or obtained directly from the patient using patient-reported outcome (PRO) measures. Although efficiency and other reasons justify data availability for a range of potentially relevant uses, these data are nearly always collected for a single specific purpose. The health care literature reflects this narrow scope, and there is limited literature on the joint use of health data for daily clinical use, clinical research, surveillance, and administrative purposes. The aim of this paper is to provide a framework for discussing the efficient use of health data with a specific focus on the role of PRO measures. PRO data may be used at an individual patient level to inform patient care or shared decision making and to tailor care to individual needs or group-level needs as a complement to health record data, such as that on mortality and readmission, in order to inform service delivery and measure the real-world effectiveness of treatment. PRO measures may be used either for their own sake, to provide valuable information from the patient perspective, or as a proxy for clinical data that would otherwise not be feasible to collect. We introduce a framework to analyze any health care activity that involves health data. The framework consists of four data processes (patient identification, data collection, data aggregation and data use), further structured into two dichotomous dimensions in each data process (level: group vs patient; timeframe: ad hoc vs systematic). This framework is used to analyze various health activities with respect to joint use of data, considering the technical, legal, organizational, and logistical challenges that characterize each data process. Finally, we propose a model for joint use of health data with data collected during follow-up as a base. Demands for health data will continue to increase, which will further add to the need for the concerted use and reuse of PRO data for parallel purposes. Repeated and uncoordinated PRO data collection for the same patient for different purposes results in misuse of resources for the patient and the health care system as well as reduced response rates owing to questionnaire fatigue. PRO data can be routinely collected both at the hospital (from inpatients as well as outpatients) and outside of hospital settings; in primary or social care settings; or in the patient’s home, provided the health informatics infrastructure is in place. In the future, clinical settings are likely to be a prominent source of PRO data; however, we are also likely to see increased remote collection of PRO data by patients in their own home (telePRO). Data collection for research and quality surveillance will have to adapt to this circumstance and adopt complementary data capture methods that take advantage of the utility of PRO data collected during daily clinical practice. The European Union’s regulation with respect to the protection of personal data—General Data Protection Regulation—imposes severe restrictions on the use of health data for parallel purposes, and steps should be taken to alleviate the consequences while still protecting personal data against misuse.

  • Source: Unsplash; Copyright: Lucian Novosel; URL: https://unsplash.com/photos/Qg-r7OxZN7A; License: Licensed by the authors.

    A Web-Based Cognitive Behavior Therapy Intervention to Improve Social and Occupational Functioning in Adults With Type 2 Diabetes (The SpringboarD Trial):...

    Abstract:

    Background: Depressive symptoms are common in people with type 2 diabetes mellitus (T2DM). Effective depression treatments exist; however, access to psychological support is characteristically low. Web-based cognitive behavioral therapy (CBT) is accessible, nonstigmatizing, and may help address substantial personal and public health impact of comorbid T2DM and depression. Objective: The aim of this study was to evaluate the Web-based CBT program, myCompass, for improving social and occupational functioning in adults with T2DM and mild-to-moderate depressive symptoms. myCompass is a fully automated, self-guided public health treatment program for common mental health problems. The impact of treatment on depressive symptoms, diabetes-related distress, anxiety symptoms, and self-care behavior was also examined. Methods: Participants with T2DM and mild-to-moderate depressive symptoms (N=780) were recruited online via Google and Facebook advertisements targeting adults with T2DM and via community and general practice settings. Screening, consent, and self-report scales were all self-administered online. Participants were randomized using double-blind computerized block randomization to either myCompass (n=391) for 8 weeks plus a 4-week tailing-off period or an active placebo intervention (n=379). At baseline and postintervention (3 months), participants completed the Work and Social Adjustment Scale, the primary outcome measure. Secondary outcome measures included the Patient Health Questionnaire-9 item, Diabetes Distress Scale, Generalized Anxiety Disorder Questionnaire-7 item, and items from the Self-Management Profile for Type 2 Diabetes. Results: myCompass users logged in an average of 6 times and completed an average of .29 modules. Healthy Lifestyles users logged in an average of 4 times and completed an average of 1.37 modules. At baseline, mean scores on several outcome measures, including the primary outcome of work and social functioning, were near to the normal range, despite an extensive recruitment process. Approximately 61.6% (473/780) of participants completed the postintervention assessment. Intention-to-treat analyses revealed improvement in functioning, depression, anxiety, diabetes distress, and healthy eating over time in both groups. Except for blood glucose monitoring and medication adherence, there were no specific between-group effects. Follow-up analyses suggested the outcomes did not depend on age, morbidity, or treatment engagement. Conclusions: Improvement in social and occupational functioning and the secondary outcomes was generally no greater for myCompass users than for users of the control program at 3 months postintervention. These findings should be interpreted in light of near-normal mean baseline scores on several variables, the self-selected study sample, and sample attrition. Further attention to factors influencing uptake and engagement with mental health treatments by people with T2DM, and the impact of illness comorbidity on patient conceptualization and experience of mental health symptoms, is essential to reduce the burden of T2DM. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12615000931572; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=368109&isReview=true (Archived by WebCite at http://www.webcitation.org/7850eg8pi)

  • Patient-provider communication during a medical encounter. Source: iStock by Getty Images; Copyright: Sasha_Suzi; URL: https://www.istockphoto.com/ca/photo/medical-consultation-gm646346710-117325259; License: Licensed by the authors.

    Perceived Patient-Provider Communication Quality and Sociodemographic Factors Associated With Watching Health-Related Videos on YouTube: A Cross-Sectional...

    Abstract:

    Background: Approximately 73% of US adults use YouTube, making it the most popular social media platform. Misinformation on social media is a growing concern; recent studies show a high proportion of misinformative health-related videos. Several studies on patient-provider communication and general health information seeking have been conducted. However, few studies to date have examined the potential association between patient-provider communication and health information seeking on specific social media platforms such as YouTube. A better understanding of this relationship may inform future health communication interventions. Objective: The aim was to use nationally representative cross-sectional data to describe the association between perceived patient-provider communication quality and sociodemographic factors on watching YouTube health-related videos. Methods: Data from the 2018 Health Information National Trends Survey were analyzed (N=3504). The primary outcome was whether participants watched a health-related video on YouTube over the past 12 months. A patient-provider communication composite score was created by summing responses about how often providers did the following: (1) gave you the chance to ask all the health-related questions you had, (2) gave attention to your feelings, (3) involved you in health care decisions as much as you wanted, (4) made sure that you understood the things you needed to do to take care of your health, (5) explained things in a way that you could understand, (6) spent enough time with you, and (7) helped you deal with feelings of uncertainty. Sociodemographic factors included age, gender, race/ethnicity, and education. Descriptive statistics and multivariable logistic regression were conducted. Results: Approximately 1067 (35% weighted prevalence) participants reported watching a health-related video on YouTube. Higher perceived quality of patient-provider communication on the composite score was significantly associated with lower odds of watching health-related videos on YouTube. Regarding sociodemographic factors, increasing age and being a high school graduate (compared with college graduate) were associated with lower odds of watching health-related videos on YouTube; whereas, Hispanic and non-Hispanic Asians were more likely to have watched a health-related video on YouTube. For individual aspects of patient-physician communication, two of seven patient-provider communication variables were significant. Those who reported that providers “sometimes” spent enough time with them had higher odds of watching a health-related video on YouTube, compared with those who said providers “always” spent enough time with them. Participants reporting that they “never” have a chance to ask all their health-related questions also had higher odds of watching health-related videos on YouTube compared with those who reported “always.” Conclusions: Higher perceived quality of patient-provider communication is associated with lower odds of watching health-related videos on YouTube. When providers do not spend enough time or give an opportunity to ask questions, patients are more likely to pursue health information on social media.

  • Source: Flickr; Copyright: Pan American Health Organization PAHO; URL: https://www.flickr.com/photos/pahowho/13383716683; License: Creative Commons Attribution + NoDerivatives (CC-BY-ND).

    Case of Paradoxical Cultural Sensitivity: Mixed Method Study of Web-Based Health Informational Materials About the Human Papillomavirus Vaccine in Israel

    Abstract:

    Background: Designing web-based informational materials regarding the human papillomavirus (HPV) vaccine has become a challenge for designers and decision makers in the health authorities because of the scientific and public controversy regarding the vaccine’s safety and effectiveness and the sexual and moral concerns related to its use. Objective: The study aimed to investigate how cultural sensitivity (CS) is articulated in the explanatory informational materials on the HPV vaccine that are posted on the websites of the Israeli health authorities. In addition, the study examined the effect of transparency on the expression of CS in the informational materials. Methods: The study employed a quantitative and qualitative content analysis of the texts of explanatory informational materials published on the Arabic and Hebrew websites of the Israel Ministry of Health and the Clalit health maintenance organization (HMO). Results: The findings revealed the differences in the dimensions of CS (based on the CS model by Resnicow) between the informational materials targeting the majority Jewish population and those targeting the minority Arab population. Indeed, the research findings point to a paradox. On the one hand, the materials appealing to the conservative Arab population exhibited CS, in that the sexual context of the vaccine was missing. On the other hand, analysis of Resnicow's deep dimensions showed that disregarding the sexual context does not allow the relevant target audience to reflect on the barriers and concerns. In addition, the way the information was provided exhibited a lack of transparency regarding the CS dimensions (surface and deep). Conclusions: The public health authorities have 2 main objectives in the context of vaccinations. One is to raise the vaccination rates and the other is to provide full and culturally sensitive information to give the public the tools to make intelligent decisions. The findings of this study indicated that despite the high uptake rate for HPV vaccination in the Arab population, the health authorities did not exercise full transparency and CS in transmitting the association between engaging in sexual relations and the necessity of the vaccination. Thus, the major challenge for the health authorities is to find ways to implement the objective of communicating information about the vaccination in a way that is transparent and culturally sensitive, even if this raises questions and fears among the public deriving from their culture.

  • Source: Flickr; Copyright: Mode Shift Move Together; URL: https://www.flickr.com/photos/76390986@N06/8405883462; License: Creative Commons Attribution + Noncommercial + ShareAlike (CC-BY-NC-SA).

    A Digital Behavioral Weight Gain Prevention Intervention in Primary Care Practice: Cost and Cost-Effectiveness Analysis

    Abstract:

    Background: Obesity is one of the largest drivers of health care spending but nearly half of the population with obesity demonstrate suboptimal readiness for weight loss treatment. Black women are disproportionately likely to have both obesity and limited weight loss readiness. However, they have been shown to be receptive to strategies that prevent weight gain. Objective: The aim of this study was to evaluate the costs and cost-effectiveness of a digital weight gain prevention intervention (Shape) for black women. Shape consisted of adaptive telephone-based coaching by health system personnel, a tailored skills training curriculum, and patient self-monitoring delivered via a fully automated interactive voice response system. Methods: A cost and cost-effectiveness analysis based on a randomized clinical trial of the Shape intervention was conducted from the payer perspective. Costs included those of delivering the program to 91 intervention participants in the trial and were summarized by program elements: self-monitoring, skills training, coaching, and administration. Effectiveness was measured in quality-adjusted life years (QALYs). The primary outcome was the incremental cost per QALY of Shape relative to usual care. Results: Shape cost an average of US $758 per participant. The base-case model in which quality of life benefits decay linearly to zero 5 years post intervention cessation, generated an incremental cost-effectiveness ratio (ICER) of US $55,264 per QALY. Probabilistic sensitivity analyses suggest an ICER below US $50,000 per QALY and US $100,000 per QALY in 39% and 98% of simulations, respectively. Results are highly sensitive to durability of benefits, rising to US $165,730 if benefits end 6 months post intervention. Conclusions: Results suggest that the Shape intervention is cost-effective based on established benchmarks, indicating that it can be a part of a successful strategy to address the nation’s growing obesity epidemic in low-income at-risk communities.

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  • Using Technology to Communicate Prenatal Health Messages to Pregnant Women: A Mixed Methods analysis of the Knowledge, Attitudes, and Perceptions of Text4Baby in Urban Immigrant Pregnant Women

    Date Submitted: May 17, 2019

    Open Peer Review Period: May 23, 2019 - Jul 18, 2019

    Background: The Text4baby™ mobile health (mhealth) program has received national attention and is acclaimed to provide pregnant women with greater access to prenatal healthcare, resources, and infor...

    Background: The Text4baby™ mobile health (mhealth) program has received national attention and is acclaimed to provide pregnant women with greater access to prenatal healthcare, resources, and information. However, without sufficient piloting, little is known whether urban and Afro-Caribbean immigrant pregnant women are open and receptive to such innovative health communication methods, or of the cultural and systematic barriers that inhibit their behavioral intent to use Text4baby. Objective: We aimed to understand the lived experiences of urban and immigrant pregnant women with accessing prenatal health care and information in Brooklyn New York; and to utilize behavioral and technology assimilation theoretical constructs to measure their knowledge, perceptions and behavioral intent to use the Text4baby program. Methods: This exploratory mixed methods study first used a phenomenological approach to explore and describe the lived experiences of pregnant women while receiving prenatal care at University Hospital of Brooklyn at Downstate prenatal health clinic. Data from the qualitative arm led to the development of a theoretically inspired survey instrument that was then used in a repeated measures pre-post test design to evaluate changes in participants’ knowledge, attitudes, beliefs and perceptions of Text4baby after a minimum of four weeks exposure to the program’s messages. Results: Three themes emerged during the focus groups and interviews and were major factors affecting participant experiences: (1) patient-provider engagement, (2) social support, and (3) acculturation. With time as a barrier to quality care; inadequate patient provider engagement often left many participants with feelings of indifference regarding the prenatal care and information they received in the clinical setting. However, pregnant women reported strongly positive attitudes towards the use of mobile health and Text4baby with 63% of survey respondents reporting strong agreement with Text4baby providing them extra support during their pregnancy. Overall, on a scale of 1 -5, participant perception of the usefulness of Text4baby ranked at 4.26, and their perception of the compatibility and relative advantage of using Text4baby ranked 4.41 and 4.15 respectively. There was a 14% increase in participants reporting their intent to use Text4baby; and a 28% increase from pre and post-test in pregnant women strongly agreeing to speak more with their doctor about the information learned through Text4baby. Conclusions: Urban and immigrant pregnant women in Brooklyn endure a number of social determinants of health that create barriers when accessing quality prenatal health care and information which negatively impacts prenatal outcomes. Low-income expecting mothers often lack access to vital information about pregnancy, preparation for birth, and best practices when caring for their newborn. Our study indicates a number of systematic, political, and other macrosystem-level factors that perpetuate health disparities in our study population. In addition, traditional, cultural, and environmental patterns also perpetuate suboptimal prenatal behaviors and practices that influence access to quality care and prenatal outcomes.

  • Serious gaming during multidisciplinary rehabilitation for patients with chronic pain or fatigue symptoms: realistic process evaluation

    Date Submitted: May 20, 2019

    Open Peer Review Period: May 23, 2019 - Jul 18, 2019

    Background: Serious gaming could support patients in learning to cope with chronic pain or functional somatic syndromes and reduce symptom burdens. Objective: To realize this potential, insight is nee...

    Background: Serious gaming could support patients in learning to cope with chronic pain or functional somatic syndromes and reduce symptom burdens. Objective: To realize this potential, insight is needed into how this could work, why, for whom, and in what actual treatment circumstances. Methods: Inspired by a realist approach, process evaluation methods were embedded before, during, and after a two-armed natural quasi-experiment (n=275). Changes in health outcome over time were compared between two groups of patients with interfering chronic pain or fatigue symptoms: 1) those who received a short additional blended mindfulness-based serious gaming intervention during a regular multidisciplinary rehabilitation program and 2) those who did not. Prior to inspecting outcome data, stakeholder focus group and patient semi-structured interview data were coded for configurations of intervention characteristics (I) in context (C) that activate mechanisms (M) for producing outcomes (O). Subsequently, hypotheses were formulated that could be tested on quantitative data using multiple regression and (moderated) mediation models. Results: Qualitative methods showed that self-discrepancies perceived by patients during serious gaming were a necessary trigger (M) for learning results with respect to self-awareness in moments of daily social interaction (O). Characteristics of serious gaming intervention (I) in context (C) that recipients considered important for gaming acceptance or learning results included design qualities, the relative advantage of an experiential learning opportunity, compatibility within rehabilitation treatment with a consistent approach and distinctive modality, (limited) flexibility to adjust to the personal preferences and contexts of the users, patients’ age and styles of managing stress or pain, provider role perceptions, and local intervention planning and facilitating processes. Quantitative methods showed that very small study group differences in self-reported depression, pain and fatigue changes (-.07<β<-.17, all 95% confidence interval upper bounds <0) were mediated by group differences in mindfulness (β=.26, 95% CI=.02-.51). Mindfulness changes were also positively associated with patient involvement in serious gaming (n=114, β=.36, P=001). Acceptance of serious gaming was lower in older patients. Outcome changes were stronger in patients that reported lower active coping with stress and pain coping before serious gaming. Finally, learning results and acceptance varied by indicators of local planning and facilitation of serious gaming. Conclusions: This study developed a tentative program theory about how and why serious gaming can additionally support learning about coping for reducing burdens of chronic pain or fatigue symptoms in certain patients and actual intervention delivery conditions. Future research can elucidate which findings are fallible, extendable, and transferable across future serious gaming contexts. This supports decisions for designing, allocating and tailoring serious gaming for optimal patient chances of important health benefit. Clinical Trial: This study was registered in the Netherlands Trial Registry NTR6020 on June 10th, 2016.

  • Analyzing the Performance of a Preeclampsia Prediction Software by Customization of Maternal Ethnicity: Cross Sectional Study

    Date Submitted: May 20, 2019

    Open Peer Review Period: May 23, 2019 - Jul 18, 2019

    Background: There is a pioneer algorithm developed by Fetal Medicine Foundation (FMF) to predict preeclampsia based on maternal characteristics combined with biophysical and/or biochemical markers. T...

    Background: There is a pioneer algorithm developed by Fetal Medicine Foundation (FMF) to predict preeclampsia based on maternal characteristics combined with biophysical and/or biochemical markers. The Afro-Caribbean ethnicity is the second risk factor, in magnitude, found in populations tested by FMF, which was not confirmed in a Brazilian scenario. Objective: This study aimed to analyze the performance of preeclampsia (PE) prediction software by customization of maternal ethnicity. Methods: It was an observational, cross-sectional study, with secondary evaluation of data from FMF first trimester screening tests of singleton pregnancies. Risk scores were calculated from maternal characteristics and biophysical markers and were presented as the risk for PE development before 34 and 37 weeks. The following steps were followed: (1)identification of women characterized as black ethnicity; (2)calculation of early and preterm PE risk, reclassifying them as white, which generated a new score; (3)comparison of the proportions of women categorized as high risk between the original and new scores; (4)construction of the receiver operator characteristic(ROC)curve; (5)calculation of the area under the curve(AUC), sensitivity and false positive rate(FPR); (6)comparison of the AUC, sensitivity and FPR of the original with the “new”risk by chi-square test. Results: A total of 1531 cases composed the final sample, with 14.3%(95%CI: 12.54-16.06) and 11.88%(95% CI: 10.26 - 13.51) were respectively classified as high risk for PE development, originally and after recalculating the new risk. The comparison of FMF2012 predictive model performance between the originally estimated risks and the estimated “new risks”, showed that the difference was not significant for sensitivity and AUC, but it was significant for FPR. Conclusions: We concluded that black ethnicity classification of Brazilian pregnant women by FMF2012 algorithm increases the false positive rate. Suppressing ethnicity effect didn’t improve the test sensitivity. By modifying demographic characteristics it is possible to improve some performance aspects of clinical prediction tests. Clinical Trial: No trial registration

  • Comparative Effectiveness of a Web-Based Patient Decision Aid for Therapeutic Options for Sickle Cell Disease

    Date Submitted: May 22, 2019

    Open Peer Review Period: May 23, 2019 - May 29, 2019

    Background: Hydroxyurea, chronic blood transfusion, and bone marrow transplantation are efficacious disease-modifying therapies for sickle cell disease (SCD) but are associated with a significant deci...

    Background: Hydroxyurea, chronic blood transfusion, and bone marrow transplantation are efficacious disease-modifying therapies for sickle cell disease (SCD) but are associated with a significant decisional dilemma because of the inherent risk-benefit tradeoffs and the lack of comparative studies. A web-based patient decision aid (PtDA) has the potential to provide patients with high-quality information about their treatment options and associated risks and benefits, help them clarify their values, and allow them to share in the process of informed medical decision making. Objective: The objective of this study was to develop a literacy-sensitive, web-based, PtDA using the conceptual framework of the Ottawa decision support framework, and to estimate in a randomized clinical trial the effectiveness of the PtDA in improving patient knowledge, and involvement in decision-making. Methods: We conducted population decisional needs assessment in a nationwide sample of patients, caregivers, stakeholders, and health care providers using qualitative interviews to identify decisional conflict (uncertainty); knowledge and expectations; values (what is important to patients); support and resources; decision types, timing, stages, and learning; and personal clinical characteristics. Interview transcripts were coded using QSR NVivo 10. Prototype PtDA underwent Alpha testing to establish usability and the accuracy of the information that it conveyed. Stakeholders participated in iterative cycles of beta testing. We conducted a randomized clinical trial of adults and of caregivers of pediatric patients to evaluate the efficacy of the PtDA. Results: A total of 223 stakeholders participated in decisional needs assessment and provided their preferences which guided the development of the PtDA (www.sickleoptions.org) which was then refined and finalized with alpha testing by 30 patients and 38 healthcare providers, and iterative cycles of beta testing by 87 stakeholders. To evaluate the efficacy of the PtDA, we enrolled 120 participants (60 in the decision aid and 60 in the usual care arm) in a randomized clinical trial. Qualitative interviews revealed high levels of usability, acceptability, and utility in education, values clarification, and preparation for decision making. The PtDA met most of the international patient decision aid collaboration standards for content, development process, and efficacy. While statistically significant improvement was observed in decisional self-efficacy and preparation for decision-making, as well reduction in overall decisional conflict score, informed sub-score and values clarification sub-score, the large amount of missing data in the completion of follow-up surveys limits the ability to draw conclusions about the effectiveness of the decision aid in improving patient knowledge and involvement in decision-making. Conclusions: We have developed a PtDA for SCD with extensive input from stakeholders. Qualitative data and surveys established the acceptability and utility of the PtDA in education and, decision making, but missing survey data limit conclusions about the effectiveness of the PtDA in Improving patient knowledge and involvement in decision making. Clinical Trial: NCT02326597

  • A cross-sectional study on quality of diabetes information identified from the Internet

    Date Submitted: May 19, 2019

    Open Peer Review Period: May 22, 2019 - Jul 17, 2019

    Background: Increasingly people seek health information from the Internet, in particular, health information on diseases that require intensive self-management, such as diabetes. However, the Internet...

    Background: Increasingly people seek health information from the Internet, in particular, health information on diseases that require intensive self-management, such as diabetes. However, the Internet is largely unregulated and the quality of online health information may not be credible. Objective: To assess the quality of online information on diabetes identified from the Internet. Methods: We used the single term “diabetes” or equivalent Chinese characters to search Google and Baidu respectively. The first 50 websites retrieved from each of the two search engines were screened for eligibility using pre-determined inclusion and exclusion criteria. Included websites were assessed on four domains: accessibility, content coverage, validity and readability. Results: We included 26 websites from Google search engine and 34 from Baidu search engine. There were significant differences in website provider (P<0.0001), but not in targeted population (P=0.832) and publication types (P=0.378), between the two search engines. The website accessibility was not statistically significantly different between the two search engines, although there were significant differences in items regarding website content coverage. There was no statistically significant difference in website validity between the Google and Baidu search engines (mean Discern score 3.3 vs 2.9, p=0.156). The results to appraise readability for English website showed that that Flesch Reading Ease scores ranged from 23.1 to 73.0 and the mean score of Flesch-Kincaid Grade Level ranged range from 5.7 to 19.6. Conclusions: The content coverage of the health information for patients with diabetes in English search engine tended to be more comprehensive than that from Chinese search engine. There was a lack of websites provided by health organisations in China. The quality of online health information for people with diabetes needs to be improved to bridge the knowledge gap between website service and public demand.

  • Progressing towards a common standard: using an online discussion forum to define concepts in chronic subjective tinnitus symptomatology

    Date Submitted: May 19, 2019

    Open Peer Review Period: May 22, 2019 - Jul 17, 2019

    Background: A minimum standard based upon consensus decision making recommends a core set of tinnitus-specific health complaints (outcome domains) which should be assessed and reported in all clinical...

    Background: A minimum standard based upon consensus decision making recommends a core set of tinnitus-specific health complaints (outcome domains) which should be assessed and reported in all clinical trials since this enables comparisons to be made across studies as well as data pooling for meta-analysis. Objective: To further clarify how the outcome domain concepts should be defined for five of the core set: tinnitus intrusiveness, sense of control, acceptance of tinnitus, concentration, and ability to ignore. This step requires a clear and fully elaborated definition for each outcome domain, moving from an abstract or vague concept to an operationalised and measurable health-related construct, so that suitable measurement instruments can then be identified. Methods: A series of five focus-group-style semi-structured discussions were conducted via an online discussion forum, each open for two weeks and ending with a vote. Participants were 148 tinnitus experts who completed a preceding online Delphi survey which had generated the original set of minimum standards. Participants were healthcare users living with tinnitus, healthcare professionals, clinical researchers, commercial representatives and funders. Results: The online discussions led to a revision of all five original plain language definitions which had been used in the preceding online Delphi survey. Each revised definition was voted by 8-53 participants and reached the pre-specified threshold of 70% consensus for all except tinnitus intrusiveness. Although a single definition was not agreed for tinnitus intrusiveness, a majority of participants shared the view that the concept should be sufficiently broad to encapsulate a range of subdomains. Examples included tinnitus awareness, unpleasantness and impact on different aspects of everyday life. Thematic analysis of the five online discussion threads gave important insights into expert interpretations of each core outcome domain, generating an operationalised and measurable health construct in each case. Conclusions: The qualitative data gathered during the online discussion forum provided important in-depth understanding of the health concepts which had raised debate during earlier face-to-face meetings. The descriptive summaries and definitions provide sufficient operationalisation of those concepts to proceed to the second stage of Core Outcome Set development which is to identify and evaluate suitable measurement instruments. This work supports the use of online peer discussion forums in defining health concepts.

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