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Journal Description

JMIR Formative Research 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, JMIR Formative Research 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 an 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 or adapting programs, and should be used while the program is ongoing to help refine and improve program activities. Thus, formative evaluation can and should also occur in the form of a process evaluation alongside a summative evaluation such as an RCT.

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

Summative evaluations of programs and apps/software that have undergone a thorough formative evaluation before launch have a better chance to be published in high-impact flagship journals; thus, we encourage authors to submit - as a first step - their formative evaluations in JMIR Formative Research (and their evaluation protocols in JMIR Research Protocols). 

JMIR Formative Research has been accepted for indexing in PubMed and PubMed Central.

 

Recent Articles:

  • Source: freepik; Copyright: pressfoto; URL: https://www.freepik.com/free-photo/hands-unrecognizable-female-doctor-writing-form-typing-laptop-keyboard_5839269.htm#page=1&query=doctor%20writing&position=0; License: Licensed by JMIR.

    Coding Systems for Clinical Decision Support: Theoretical and Real-World Comparative Analysis

    Abstract:

    Background: Effective clinical decision support systems require accurate translation of practice recommendations into machine-readable artifacts; developing code sets that represent clinical concepts are an important step in this process. Many clinical coding systems are currently used in electronic health records, and it is unclear whether all of these systems are capable of efficiently representing the clinical concepts required in executing clinical decision support systems. Objective: The aim of this study was to evaluate which clinical coding systems are capable of efficiently representing clinical concepts that are necessary for translating artifacts into executable code for clinical decision support systems. Methods: Two methods were used to evaluate a set of clinical coding systems. In a theoretical approach, we extracted all the clinical concepts from 3 preventive care recommendations and constructed a series of code sets containing codes from a single clinical coding system. In a practical approach using data from a real-world setting, we studied the content of 1890 code sets used in an internationally available clinical decision support system and compared the usage of various clinical coding systems. Results: SNOMED CT and ICD-10 (International Classification of Diseases, Tenth Revision) proved to be the most accurate clinical coding systems for most concepts in our theoretical evaluation. In our practical evaluation, we found that International Classification of Diseases (Tenth Revision) was most often used to construct code sets. Some coding systems were very accurate in representing specific types of clinical concepts, for example, LOINC (Logical Observation Identifiers Names and Codes) for investigation results and ATC (Anatomical Therapeutic Chemical Classification) for drugs. Conclusions: No single coding system seems to fulfill all the needs for representing clinical concepts for clinical decision support systems. Comprehensiveness of the coding systems seems to be offset by complexity and forms a barrier to usability for code set construction. Clinical vocabularies mapped to multiple clinical coding systems could facilitate clinical code set construction.

  • Source: Freepik; Copyright: yanalya; URL: https://www.freepik.com/free-photo/portrait-man-grabbing-his-head-despair-near-laptop_1281116.htm#page=1&query=university%20stress&position=19; License: Licensed by JMIR.

    Investigating the Impact of COVID-19 Lockdown on the Psychological Health of University Students and Their Attitudes Toward Mobile Mental Health Solutions:...

    Abstract:

    Background: The COVID-19 outbreak was first reported to the World Health Organization on December 31, 2019, and it was officially declared a public health emergency of international concern on January 30, 2020. The COVID-19 outbreak and the safety measures taken to control it caused many psychological issues in populations worldwide, such as depression, anxiety, and stress. Objective: The objectives of this study were to assess the psychological effects of the lockdown due to the COVID-19 outbreak on university students in the United Arab Emirates (UAE) and to investigate the students’ awareness of mobile mental health care apps as well as their attitudes toward the use of these apps. Methods: A two-part self-administered web-based questionnaire was delivered to students at United Arab Emirates University. The first part of the questionnaire assessed the mental state of the participants using the 12-item General Health Questionnaire (GHQ-12), while the second part contained questions investigating the participants’ awareness of and attitudes toward mental health care apps. Students were invited to fill out the web-based questionnaire via social media and mailing lists. Results: A total of 154 students participated in the survey, and the majority were female. The results of the GHQ-12 analysis showed that the students were experiencing psychological issues related to depression and anxiety as well as social dysfunction. The results also revealed a lack of awareness of mental health care apps and uncertainty regarding the use of such apps. Approximately one-third of the participants (44/154, 28.6%) suggested preferred functionalities and characteristics of mobile mental health care apps, such as affordable price, simple design, ease of use, web-based therapy, communication with others experiencing the same issues, and tracking of mental status. Conclusions: Like many groups of people worldwide, university students in the UAE were psychologically affected by the lockdown due to the COVID-19 outbreak. Although apps can be useful tools for mental health care delivery, especially in circumstances such as those produced by the outbreak, the students in this study showed a lack of awareness of these apps and mixed attitudes toward them. Improving the digital health literacy of university students in the UAE by increasing their awareness of mental health care apps and the treatment methods and benefits of the apps, as well as involving students in the app creation process, may encourage students to use these tools for mental health care.

  • An outpatient encounter with a pregnant women using HADA, an Intelligent Computarized Asistant, with the knowledge structured described in the article. Source: Image created by the Authors; Copyright: The Authors; URL: http://formative.jmir.org/2020/10/e17512/; License: Creative Commons Attribution + NoDerivatives (CC-BY-ND).

    XML Data and Knowledge-Encoding Structure for a Web-Based and Mobile Antenatal Clinical Decision Support System: Development Study

    Abstract:

    Background: Displeasure with the functionality of clinical decision support systems (CDSSs) is considered the primary challenge in CDSS development. A major difficulty in CDSS design is matching the functionality to the desired and actual clinical workflow. Computer-interpretable guidelines (CIGs) are used to formalize medical knowledge in clinical practice guidelines (CPGs) in a computable language. However, existing CIG frameworks require a specific interpreter for each CIG language, hindering the ease of implementation and interoperability. Objective: This paper aims to describe a different approach to the representation of clinical knowledge and data. We intended to change the clinician’s perception of a CDSS with sufficient expressivity of the representation while maintaining a small communication and software footprint for both a web application and a mobile app. This approach was originally intended to create a readable and minimal syntax for a web CDSS and future mobile app for antenatal care guidelines with improved human-computer interaction and enhanced usability by aligning the system behavior with clinical workflow. Methods: We designed and implemented an architecture design for our CDSS, which uses the model-view-controller (MVC) architecture and a knowledge engine in the MVC architecture based on XML. The knowledge engine design also integrated the requirement of matching clinical care workflow that was desired in the CDSS. For this component of the design task, we used a work ontology analysis of the CPGs for antenatal care in our particular target clinical settings. Results: In comparison to other common CIGs used for CDSSs, our XML approach can be used to take advantage of the flexible format of XML to facilitate the electronic sharing of structured data. More importantly, we can take advantage of its flexibility to standardize CIG structure design in a low-level specification language that is ubiquitous, universal, computationally efficient, integrable with web technologies, and human readable. Conclusions: Our knowledge representation framework incorporates fundamental elements of other CIGs used in CDSSs in medicine and proved adequate to encode a number of antenatal health care CPGs and their associated clinical workflows. The framework appears general enough to be used with other CPGs in medicine. XML proved to be a language expressive enough to describe planning problems in a computable form and restrictive and expressive enough to implement in a clinical system. It can also be effective for mobile apps, where intermittent communication requires a small footprint and an autonomous app. This approach can be used to incorporate overlapping capabilities of more specialized CIGs in medicine.

  • Source: Pexels; Copyright: Ivan Oboleninov; URL: https://www.pexels.com/photo/woman-sleeping-935777/; License: Licensed by the authors.

    Understanding Problems With Sleep, Sexual Functioning, Energy, and Appetite Among Patients Who Access Transdiagnostic Internet-Delivered Cognitive Behavioral...

    Abstract:

    Background: Transdiagnostic internet-delivered cognitive behavioral therapy (T-ICBT) is an effective treatment for anxiety and depression, and nowadays, there is interest in exploring ways to optimize T-ICBT in routine care. T-ICBT programs are designed to address the primary cognitive-affective and behavioral symptoms of anxiety and depression (eg, low mood, worry, anhedonia, and avoidance). Treatment also has the potential to resolve other symptom concerns (eg, sleep disruption, sexual dysfunction, lack of energy, and appetite or weight changes). Having additional information regarding the extent of these concerns and how concerns change over time could prove beneficial for further development of T-ICBT in routine care. Objective: This exploratory formative study aims to better understand sleep, sexual functioning, energy, and appetite concerns among T-ICBT clients seeking treatment for depression and anxiety. A qualitative analytic approach was used to identify themes in the symptom concerns reported by patients in the areas of sleep, sexual functioning, energy, and appetite at the time of enrollment. Patient responses to related items from screening measures for anxiety and depression were also examined pre- and posttreatment. Methods: Patients in routine care who applied for a T-ICBT program for depression and anxiety over a 1-year period were included in this study. As part of the application and screening process, participants completed depression and anxiety symptom measures (ie, 9-item Patient Health Questionnaire and 7-item Generalized Anxiety Disorder scale). These same measures were administered posttreatment. Subsequently, they were asked if they were experiencing any problems with sleep, sexual activity, energy, or appetite (yes or no). If their response was yes, they were presented with an open-ended comment box that asked them to describe the problems they had experienced in those areas. Results: A total of 462 patients were admitted to T-ICBT during the study period, of which 438 endorsed having some problems with sleep, sexual activity, energy, or appetite. The analysis of open-ended responses indicated that 73.4% (339/462) of patients reported sleep problems (eg, difficulty initiating or maintaining sleep), 69.3% (320/462) of patients reported problems with energy or motivation (eg, tiredness and low motivation), 57.4% (265/462) of patients reported appetite or body weight concerns (eg, changes in appetite and weight loss or gain), and 30.1% (139/462) of patients described concerns with sexual functioning (eg, loss of interest in sex and difficulty with arousal). Item analysis of symptom measures demonstrated that T-ICBT produced improvements in sleep, energy, and appetite in 8 weeks. Sexual dysfunction and weight changes were not represented in the screening measures, so it remains unclear what effect T-ICBT has on these symptoms. Conclusions: Sleep disruption, lack of energy, appetite or weight changes, and sexual dysfunction are common concerns reported by clients enrolled in T-ICBT in routine practice and may deserve greater attention in T-ICBT program development and administration.

  • Source: Flickr; Copyright: Nenad Stojkovic; URL: https://www.flickr.com/photos/156445661@N02/50141353473; License: Licensed by JMIR.

    Integration of Online Treatment Into the “New Normal” in Mental Health Care in Post–COVID-19 Times: Exploratory Qualitative Study

    Abstract:

    Background: The COVID-19 pandemic has necessitated an immediate and large-scale uptake of online treatment for mental health care. However, there is uncertainty about what the “new normal” in mental health care will be like in post–COVID-19 times. To what extent will the experiences gained during the pandemic influence a sustainable adoption and implementation of online mental health care treatment in the future? Objective: In this paper, we aim to formulate expectations with regard to the sustainability of online mental health care after COVID-19. Methods: In an interview study, 11 mental health care professionals were asked about their experiences and expectations for the future. Participants were recruited from a mental health care organization in the Netherlands. The interviews took place between April 7-30, 2020, at the peak of the COVID-19 crisis in the Netherlands. The data were analyzed using a thematic coding method. Results: From the interviews, we learn that the new normal in mental health care will most likely consist of more blended treatments. Due to skill enhancement and (unexpected) positive experiences with online treatment, an increase in adoption is likely to take place. However, not all experiences promise a successful and sustainable upscaling of online treatment in the future. Mental health care professionals are learning that not all clients are able to benefit from this type of treatment. Conclusions: Sustainable upscaling of online mental health care requires customized solutions, investments in technology, and flexibility of mental health care providers. Online treatment could work for those who are open to it, but many factors influence whether it will work in specific situations. There is work to be done before online treatment is inherently part of mental health care.

  • Source: Image created by the Authors/Placeit; Copyright: The Authors/Placeit; URL: http://formative.jmir.org/2020/10/e19533/; License: Licensed by JMIR.

    A Web-Based, Mobile-Responsive Application to Screen Health Care Workers for COVID-19 Symptoms: Rapid Design, Deployment, and Usage

    Abstract:

    Background: As of July 17, 2020, the COVID-19 pandemic has affected over 14 million people worldwide, with over 3.68 million cases in the United States. As the number of COVID-19 cases increased in Massachusetts, the Massachusetts Department of Public Health mandated that all health care workers be screened for symptoms daily prior to entering any hospital or health care facility. We rapidly created a digital COVID-19 symptom screening tool to enable this screening for a large, academic, integrated health care delivery system, Partners HealthCare, in Boston, Massachusetts. Objective: The aim of this study is to describe the design and development of the COVID Pass COVID-19 symptom screening application and report aggregate usage data from the first three months of its use across the organization. Methods: Using agile principles, we designed, tested, and implemented a solution over the span of one week using progressively customized development approaches as the requirements and use case become more solidified. We developed the minimum viable product (MVP) of a mobile-responsive, web-based, self-service application using research electronic data capture (REDCap). For employees without access to a computer or mobile device to use the self-service application, we established a manual process where in-person, socially distanced screeners asked employees entering the site if they have symptoms and then manually recorded the responses in an Office 365 Form. A custom .NET Framework application solution was developed as COVID Pass was scaled. We collected log data from the .NET application, REDCap, and Microsoft Office 365 from the first three months of enterprise deployment (March 30 to June 30, 2020). Aggregate descriptive statistics, including overall employee attestations by day and site, employee attestations by application method (COVID Pass automatic screening vs manual screening), employee attestations by time of day, and percentage of employees reporting COVID-19 symptoms, were obtained. Results: We rapidly created the MVP and gradually deployed it across the hospitals in our organization. By the end of the first week, the screening application was being used by over 25,000 employees each weekday. After three months, 2,169,406 attestations were recorded with COVID Pass. Over this period, 1865/160,159 employees (1.2%) reported positive symptoms. 1,976,379 of the 2,169,406 attestations (91.1%) were generated from the self-service screening application. The remainder were generated either from manual attestation processes (174,865/2,169,406, 8.1%) or COVID Pass kiosks (25,133/2,169,406, 1.2%). Hospital staff continued to work 24 hours per day, with staff attestations peaking around shift changes between 7 and 8 AM, 2 and 3 PM, 4 and 6 PM, and 11 PM and midnight. Conclusions: Using rapid, agile development, we quickly created and deployed a dedicated employee attestation application that gained widespread adoption and use within our health system. Further, we identified 1865 symptomatic employees who otherwise may have come to work, potentially putting others at risk. We share the story of our implementation, lessons learned, and source code (via GitHub) for other institutions who may want to implement similar solutions.

  • Source: Pexels; Copyright: Andrea Piacquadio; URL: https://www.pexels.com/photo/woman-in-brown-and-beige-plaid-dress-shirt-holding-black-smartphone-3884252/; License: Licensed by JMIR.

    Using ADAPT-ITT to Modify a Telephone-Based HIV Prevention Intervention for SMS Delivery: Formative Study

    Abstract:

    Background: African American adolescent females are disproportionately affected by sexually transmitted infections (STIs) and HIV. Given the elevated risk of STIs and HIV in African American women, there is an urgent need to identify innovative strategies to enhance the adoption and maintenance of STI and HIV preventive behaviors. Texting is a promising technology for creating preventive maintenance interventions (PMIs) that extend the efficacy of the original intervention. However, little guidance in public health literature is available for developing this type of application. Objective: This paper describes a formative pilot study that incorporates user experience methods to design and test PMI texts for Afiya, an original evidence-based intervention (EBI) specifically designed for African American adolescent females. This study aims to describe the adaptation process of health educator–led phone calling to text-based communication. Methods: The formative process followed the assessment, decision, adaptation, production, topical experts-integration, training, testing (ADAPT-ITT) framework for adapting EBIs and using them in a new setting, for a new target population or a modified intervention strategy. This study presents the details of how the phases of the ADAPT-ITT framework were applied to the design of the adaptation. An advisory board was constituted from the target population, consisting of 6 African American women aged 18-24 years, participating in formative activities for 12 weeks, and involving components of the PMI design. As Afiya included a telephone-based PMI, developers of the original Afiya phone scripts crafted the initial design of the SMS-based texts and texting protocol. The advisory board participated in the 1-day Afiya workshop, followed by 4 weeks of texting PMI messages and a midcourse focus group, followed by 4 more weeks of texting PMI messages, ultimately ending with a final focus group. At the advisory board’s request, this phase included an optional, additional week of text-based PMI messages. Results: The methods provided a rich source of data and insights into the fundamental issues involved when constructing SMS-based PMI for this target population and for this EBI. Prior contact and context are essential as the health educator was identified as a key persona in the process and the messages were situated in the original (workshop) context. Narrative adaptations for personas emerged from advisory board discussions. Suggestions on how to expand the PMI to current, specific social contexts indicated that the use of narrative analysis is warranted. Conclusions: The use of existing EBIs incorporating telephone-based PMI scripts facilitated the initial design of the texts, with a subsequent narrative analysis of the advisory board data providing additional adjustments given the actual context. Additional examination of the advisory board feedback revealed that personas would offer insight into and opportunities for a persona-specific modification of texting narratives.

  • Source: Image created by the Authors/Placeit; Copyright: The Authors/Placeit; URL: https://formative.jmir.org/2020/10/e20501; License: Licensed by JMIR.

    Ethnicity Differences in Sleep Changes Among Prehypertensive Adults Using a Smartphone Meditation App: Dose-Response Trial

    Abstract:

    Background: African Americans (AAs) experience greater sleep quality problems than non-Hispanic Whites (NHWs). Meditation may aid in addressing this disparity, although the dosage levels needed to achieve such benefits have not been adequately studied. Smartphone apps present a novel modality for delivering, monitoring, and measuring adherence to meditation protocols. Objective: This 6-month dose-response feasibility trial investigated the effects of a breathing awareness meditation (BAM) app, Tension Tamer, on the secondary outcomes of self-reported and actigraphy measures of sleep quality and the modulating effects of ethnicity of AAs and NHWs. Methods: A total of 64 prehypertensive adults (systolic blood pressure <139 mm Hg; 31 AAs and 33 NHWs) were randomized into 3 different Tension Tamer dosage conditions (5,10, or 15 min twice daily). Sleep quality was assessed at baseline and at 1, 3, and 6 months using the Pittsburgh Sleep Quality Index (PSQI) and 1-week bouts of continuous wrist actigraphy monitoring. The study was conducted between August 2014 and October 2016 (IRB #Pro00020894). Results: At baseline, PSQI and actigraphy data indicated that AAs had shorter sleep duration, greater sleep disturbance, poorer efficiency, and worse quality of sleep (range P=.03 to P<.001). Longitudinal generalized linear mixed modeling revealed a dose effect modulated by ethnicity (P=.01). Multimethod assessment showed a consistent pattern of NHWs exhibiting the most favorable responses to the 5-min dose; they reported greater improvements in sleep efficiency and quality as well as the PSQI global value than with the 10-min and 15-min doses (range P=.04 to P<.001). Actigraphy findings revealed a consistent, but not statistically significant, pattern in the 5-min group, showing lower fragmentation, longer sleep duration, and higher efficiency than the other 2 dosage conditions. Among AAs, actigraphy indicated lower sleep fragmentation with the 5-min dose compared with the 10-min and 15-min doses (P=.03 and P<.001, respectively). The 10-min dose showed longer sleep duration than the 5-min and 15-min doses (P=.02 and P<.001, respectively). The 5-min dose also exhibited significantly longer average sleep than the 15-min dose (P=.03). Conclusions: These findings indicate the need for further study of the potential modulating influence of ethnicity on the impact of BAM on sleep indices and user-centered exploration to ascertain the potential merits of refining the Tension Tamer app with attention to cultural tailoring among AAs and NHWs with pre-existing sleep complaints.

  • Source: Adobe Stock; Copyright: Syda Productions; URL: https://stock.adobe.com/ca/images/happy-pregnant-woman-with-smartphone-at-home/179331309?continue_checkout=1&asset_id=179331309; License: Licensed by JMIR.

    Expanding Access to Perinatal Depression Treatment in Kenya Through Automated Psychological Support: Development and Usability Study

    Abstract:

    Background: Depression during pregnancy and in the postpartum period is associated with poor outcomes for women and their children. Although effective interventions exist for common mental disorders that occur during pregnancy and the postpartum period, most cases in low- and middle-income countries go untreated because of a lack of trained professionals. Task-sharing models such as the Thinking Healthy Program have shown potential in feasibility and efficacy trials as a strategy for expanding access to treatment in low-resource settings; however, there are significant barriers to scale-up. We address this gap by adapting Thinking Healthy for automated delivery via a mobile phone. This new intervention, Healthy Moms, uses an existing artificial intelligence system called Tess (Zuri in Kenya) to drive conversations with users. Objective: This prepilot study aims to gather preliminary data on the Healthy Moms perinatal depression intervention to learn how to build and test a more robust service. Methods: We conducted a single-case experimental design with pregnant women and new mothers recruited from public hospitals outside of Nairobi, Kenya. We invited these women to complete a brief, automated screening delivered via text messages to determine their eligibility. Enrolled participants were randomized to a 1- or 2-week baseline period and then invited to begin using Zuri. We prompted participants to rate their mood via SMS text messaging every 3 days during the baseline and intervention periods, and we used these preliminary repeated measures data to fit a linear mixed-effects model of response to treatment. We also reviewed system logs and conducted in-depth interviews with participants to study engagement with the intervention, feasibility, and acceptability. Results: We invited 647 women to learn more about Zuri: 86 completed our automated SMS screening and 41 enrolled in the study. Most of the enrolled women submitted at least 3 mood ratings (31/41, 76%) and sent at least 1 message to Zuri (27/41, 66%). A third of the sample engaged beyond registration (14/41, 34%). On average, women who engaged post registration started 3.4 (SD 3.2) Healthy Moms sessions and completed 3.1 (SD 2.9) of the sessions they started. Most interviewees who tried Zuri reported having a positive attitude toward the service and expressed trust in Zuri. They also attributed positive life changes to the intervention. We estimated that using this alpha version of Zuri may have led to a 7% improvement in mood. Conclusions: Zuri is feasible to deliver via SMS and was acceptable to this sample of pregnant women and new mothers. The results of this prepilot study will serve as a baseline for future studies in terms of recruitment, data collection, and outcomes.

  • Source: Public Domain Pictures.net; Copyright: Cheryl Holt; URL: https://www.publicdomainpictures.net/en/view-image.php?image=94106&picture=smoking; License: Public Domain (CC0).

    Perceptions of Mobile Apps for Smoking Cessation Among Young People in Community Mental Health Care: Qualitative Study

    Abstract:

    Background: Young adults with serious mental illness are over twice as likely to have tobacco use disorder than those in the general population and are less likely to utilize proven treatment methods during quit attempts. However, little research has evaluated the efficacy of interventions for this group. Smartphone apps may be an underutilized tool for tobacco use disorder among young adults with serious mental illness. Objective: The aim of this study was to explore attitudes toward smoking cessation apps and preferences regarding app design in young adult smokers with serious mental illness. Methods: Five focus groups involving 25- to 35-year-old adults with serious mental illness receiving treatment at a community mental health center were conducted between May 2019 and August 2019. Three researchers independently coded transcripts and identified themes using thematic analysis. Results: Participants (n=22) were individuals who smoke daily: 10 (46%) self-identified as female, 18 (82%) self-identified as White, and 9 (41%) had psychotic disorders. Key themes that emerged included a general interest in using health apps; a desire for apps to provide ongoing motivation during a quit attempt via social support, progress tracking, and rewards; a desire for apps to provide distraction from smoking; concerns about app effectiveness due to a lack of external accountability; and concerns that apps could trigger cravings or smoking behavior by mentioning cigarettes or the act of smoking. Conclusions: Apps have the potential to support smoking cessation or reduction efforts among young adults with serious mental illness. However, they may require tailoring, optimization, and clinical support to effectively promote cessation in this population.

  • Source: Unsplash; Copyright: Anaya Katlego; URL: https://unsplash.com/photos/iaHFmpXVltw; License: Licensed by JMIR.

    Phone Calls to Retain Research Participants and Determinants of Reachability in an African Setting: Observational Study

    Abstract:

    Background: Long-term retention of research participants in studies is challenging. In research in sub-Saharan Africa, phone calls are the most frequently used method to distantly engage with participants. Objective: We aimed to get insight into the effectiveness of phone calls to retain contact with participants and evaluated determinants of reachability. Methods: A cross-sectional study was performed using the databases of two randomized controlled trials investigating different kinds of antiretroviral therapy in HIV-positive patients. One trial finished in 2018 (study 1), and the other finished in 2015 (study 2). A random sample size of 200 participants per study was obtained. There were up to 3 phone numbers available per participant collected during the studies. Participants received a maximum of 3 phone calls on every available number on different days and at different times. Voicemails were left, and emails sent wherever possible. We documented how many calls were answered, who answered, as well as after how many attempts participants were reached. To further increase our understanding of reachability, we conducted a short questionnaire assessing factors contributing to reachability. The study was approved by the Research Ethics Committee of the University of Witwatersrand, Johannesburg, South Africa (reference number M1811107). Results: In our sample size of n=200 per study, study 1, with a median time of 11 months since the last visit at the research site, had a response rate of 70.5% (141/200) participants while study 2, with a median duration of 55 months since the last visit, had a response rate of 50.0% (100/200; P<.001). In study 1, 61.5% (123/200) of calls were answered directly by the participant while this was 36.0% (72/200) in study 2 (P=.003). The likelihood of reaching a participant decreased with time (odds ratio [OR] 0.73, 95% CI 0.63 to 0.84) for every year since the last face-to-face visit. Having more phone numbers per participant increased reachability (OR 2.32, 95% CI 1.24 to 4.36 for 2 phone numbers and OR 3.03, 95% CI 1.48 to 6.22 for 3 phone numbers compared with 1 number). A total of 141 of 241 reached participants responded to the questionnaire. Of the 93 participants who had changed phone numbers, 5% (50/93) had changed numbers because their phone was stolen. The most preferred method of being contacted was direct calling (128/141) with participants naming this method followed by WhatsApp (69/141). Conclusions: Time since last visit and the number of phone numbers listed were the only determinants of reachability. Longer follow-up time is accompanied with a decrease in reachability by phone while more listed phone numbers increases the likelihood that someone can be reached. Trial Registration: ClinicalTrials.gov NCT02671383; https://clinicaltrials.gov/ct2/show/NCT02671383 and ClinicalTrials.gov NCT02670772; https://clinicaltrials.gov/ct2/show/NCT02670772

  • Source: Freepik; Copyright: yanalya; URL: https://www.freepik.com/free-photo/couple-lying-asleep-bed-man-wearing-wristband-smart-watch_3955556.htm#page=1&query=sleep%20fitness%20tracker&position=5; License: Licensed by JMIR.

    Evaluating the Relationship Between Fitbit Sleep Data and Self-Reported Mood, Sleep, and Environmental Contextual Factors in Healthy Adults: Pilot...

    Authors List:

    Abstract:

    Background: Mental health disorders can disrupt a person’s sleep, resulting in lower quality of life. Early identification and referral to mental health services are critical for active duty service members returning from forward-deployed missions. Although technologies like wearable computing devices have the potential to help address this problem, research on the role of technologies like Fitbit in mental health services is in its infancy. Objective: If Fitbit proves to be an appropriate clinical tool in a military setting, it could provide potential cost savings, improve clinician access to patient data, and create real-time treatment options for the greater active duty service member population. The purpose of this study was to determine if the Fitbit device can be used to identify indicators of mental health disorders by measuring the relationship between Fitbit sleep data, self-reported mood, and environmental contextual factors that may disrupt sleep. Methods: This observational cohort study was conducted at the Madigan Army Medical Center. The study included 17 healthy adults who wore a Fitbit Flex for 2 weeks and completed a daily self-reported mood and sleep log. Daily Fitbit data were obtained for each participant. Contextual factors were collected with interim and postintervention surveys. This study had 3 specific aims: (1) Determine the correlation between daily Fitbit sleep data and daily self-reported sleep, (2) Determine the correlation between number of waking events and self-reported mood, and (3) Explore the qualitative relationships between Fitbit waking events and self-reported contextual factors for sleep. Results: There was no significant difference in the scores for the pre-intevention Pittsburg Sleep Quality Index (PSQI; mean 5.88 points, SD 3.71 points) and postintervention PSQI (mean 5.33 points, SD 2.83 points). The Wilcoxon signed-ranks test showed that the difference between the pre-intervention PSQI and postintervention PSQI survey data was not statistically significant (Z=0.751, P=.05). The Spearman correlation between Fitbit sleep time and self-reported sleep time was moderate (r=0.643, P=.005). The Spearman correlation between number of waking events and self-reported mood was weak (r=0.354, P=.163). Top contextual factors disrupting sleep were “pain,” “noises,” and “worries.” A subanalysis of participants reporting “worries” found evidence of potential stress resilience and outliers in waking events. Conclusions: Findings contribute valuable evidence on the strength of the Fitbit Flex device as a proxy that is consistent with self-reported sleep data. Mood data alone do not predict number of waking events. Mood and Fitbit data combined with further screening tools may be able to identify markers of underlying mental health disease.

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    Open Peer Review Period: Oct 18, 2020 - Dec 13, 2020

    Background: Journalists comprise the largest group of verified, active Twitter accounts (Kamps, 2015; Mullin, 2015), but little, if anything, is known about the ways in which schools of nursing use Tw...

    Background: Journalists comprise the largest group of verified, active Twitter accounts (Kamps, 2015; Mullin, 2015), but little, if anything, is known about the ways in which schools of nursing use Twitter to invite attention from and engagement with journalists and other members of the media. This study seeks to fill this gap. Objective: The study sought to answer two questions: (1) To what extent are the top 50 schools of nursing using hashtags that could attract/invite attention from journalists and media outlets on Twitter?; and (2) To what extent are the top fifty schools of nursing being followed on Twitter by journalists and media outlets? Methods: For the purposes of this study, hashtags were considered to be either inward-facing or outward-facing. Inward-facing hashtags were those intended to invite attention from/ interaction with nurses, members of the University/School community, or attendees at a nursing conference or Twitter chat. Outward-facing hashtags were those intended to invite attention from/interaction with people outside of the nursing and University/School community. Among the 11,143 tweets containing at least one hashtag, 79.83% of hashtags used were inward-facing. Only 1.15% (n=668) of the 58,184 unduplicated user accounts following the forty-seven schools of nursing belonged to members of the media. Results: For the purposes of this study, hashtags were considered to be either inward-facing or outward-facing. Inward-facing hashtags were those intended to invite attention from/ interaction with nurses, members of the University/School community, or attendees at a nursing conference or Twitter chat. Outward-facing hashtags were those intended to invite attention from/interaction with people outside of the nursing and University/School community. Among the 11,143 tweets containing at least one hashtag, 79.83% of hashtags used were inward-facing. Only 1.15% (n=668) of the 58,184 unduplicated user accounts following the forty-seven schools of nursing belonged to members of the media. Conclusions: Although the top forty-seven schools of nursing have an active social media presence on Twitter, collectively their use of hashtags functions more like an intranet to communicate with other nurses rather than as a tool to invite attention from and dialogue with members of the media. This may help to explain why so few members of the media follow these schools of nursing on Twitter. Schools of nursing school highlight the work of their faculty and students by using hashtags to connect that work to current events of interest to the general public.

  • Effectiveness of smartphone-based cognitive behavioral therapy among patients with major depression: A systematic review

    Date Submitted: Oct 1, 2020

    Open Peer Review Period: Oct 1, 2020 - Nov 26, 2020

    Background: Depression is often associated with rapid changes in mood and quality of life that persist for a period of two weeks. Despite medical innovations, there are problems in the provision of ca...

    Background: Depression is often associated with rapid changes in mood and quality of life that persist for a period of two weeks. Despite medical innovations, there are problems in the provision of care. Long waiting times for treatment and high recurrence rates of depression cause enormous costs for the health care systems. At the same time, comprehensive limitations in physical, psychological and social dimensions are observed for patients with depression, which significantly reduce the quality of life. In addition to patient-specific limitations, undersupply and inappropriate health care can be determined. For this reason, new forms of care are discussed. Smartphone-based therapy is considered to have great potential, because of their reach and easy accessibility. Low socioeconomic groups, which are always hard to reach for public health intervention, can now be accessed due to the high dispersion of smartphones. There is still little information about the impact and the mechanisms of smartphone-based therapy on depression. In a systematic literature review, the health implications of smartphone-based therapy were presented in comparison to standard care. Objective: The objective of this review was: (1) to identify and summarize existing evidence regarding smartphone-based cognitive behavioral therapy for patients with depression and (2) to present health implications of smartphone-based cognitive behavioral therapy of considered endpoints. Methods: A systematic literature review was conducted which identified relevant studies by means of inclusion and exclusion criteria. For this purpose, the databases PubMed and Psyndex were systematically searched using a search syntax. The endpoints depressive symptoms, depression-related anxiety, self-efficacy or self-esteem and quality of life were analyzed. Identified studies were evaluated concerning study quality and risk of bias. After applying the inclusion and exclusion criteria, 8 studies were identified. Results: The examined studies reported contradictory results regarding the investigated endpoints. In addition, due to clinical and methodological heterogeneity, it was difficult to derive evident results. All included studies reported effects on depressive symptoms. The other investigated endpoints were only reported by isolated studies. Only 50 % (n=4) of the studies reported effects on depression-related anxiety, self-efficacy or self-esteem and quality of life. In conclusion, no clear implications of the smartphone-based cognitive behavioral therapy could be established. Conclusions: Evidence for the treatment of depression by smartphone-based cognitive behavioral therapy is limited. Additional research projects are needed to demonstrate the effects of smartphone-based cognitive behavioral therapy in the context of evidence-based medicine and to enable its translation into standard care. Participatory technology development might help to address current problems in mHealth intervention studies.

  • Does the taste of the plain packaged cigarettes in Saudi Arabia really changed and differ from the branded cigarettes or it is a natural sensory change? Pilot Experimental Study

    Date Submitted: Sep 21, 2020

    Open Peer Review Period: Sep 20, 2020 - Nov 15, 2020

    Background: Saudi Arabia implemented tobacco plain packaging in August 2019. After few weeks of implementation huge number of smokers complained in various media channels especially social media (Twit...

    Background: Saudi Arabia implemented tobacco plain packaging in August 2019. After few weeks of implementation huge number of smokers complained in various media channels especially social media (Twitter) claiming extreme change of how the cigarette taste, increase the frequency of coughing, and for some hospitalization caused by shortness of breath. Objective: The main objective is to answer the question: Does the taste of the plain packaged cigarettes recently implemented in Saudi Arabia really changed and differ from the branded cigarettes or it is a natural sensory change? The secondary objective is to observation of frequency of immediate cough or shortness of breath. Methods: This study is a pilot prospective, one-group posttest-only design, which recruited smokers 18 years old and above, who are currently smoking cigarettes and cleared upon physical assessment before the experiment. Participants received 6 sequences of different random exposures (3 puffs) to 3 plain packaged cigarettes (2 from the favorite brand and 1 other brand “control”) and 3 branded cigarettes (2 from the favorite brand and 1 other brand “control”). Participants wore Virtual Reality Goggles (VR) accompany with a special software to alter the visual reality and wore gloves to alter the touch sensation. Results: Participants were not able to identify the correct type of cigarettes (plain or branded (Estimate of fixed effect -0.01 p=0.79). Moreover, there were no differences in the ability of the participants to identify their favorite brand t(-0.63) mean=0.47 p = 0.53. In terms of immediate coughing out of the 108 experiments 1 episode of short coughing was observed and it was attributed to the branded cigarette not the plain packaged. Conclusions: After controlling the visual and touch sensation participants were not able to difference between branded and plain packaged cigarettes in terms of taste or inducing immediate shortness of breath or cough. Interestingly, participants were not able to identify their favorite brand.

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