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JMIR Formative Research
Process evaluations, early results, and feasibility/pilot studies of digital and non-digital interventions
Background: The NHS’ ‘Long term plan’ details plans to make digital interactions available to all patients in five years. Teleconsultations can improve access to specialist services however there is a lack of UK evidence for the use of teleconsultations in an Oncology setting. Here we describe a service evaluation of teleconsultations for patients attending a regional brain metastases (BM) clinic. These patients have unique travel restrictions that prevent them from driving. Objective: To assess the feasibility and acceptability of a teleconsultation service in this setting. Methods: From April 2018 to October 2018 all patients attending the BM clinic were offered the choice of a teleconsultation in place of a face-to-face appointment. Feedback was assessed using a satisfaction questionnaire and data was collected on all clinic attendances. Results: Sixty-nine individual patients had 119 appointments over the duration of the pilot. Of these, 36 were new patient appointments and 73 were follow ups. Of these, 24 patients (35%) took part in 41 (34%) teleconsultations. User satisfaction was high and no patients who took part in a teleconsultation reverted to face-to-face appointments. These patients avoided 2521 miles (61.6 miles per appointment) of hospital associated travel and travel costs of £441.48 (£10.78 per appointment). Conclusions: Teleconsultations appear to be acceptable in this cohort of patients who have brain metastases attending a regional stereotactic radiosurgery service with the potential for significant savings in travel and expenses evident.
(Toronto, Nov 29th, 2018) We are pleased to report that JMIR Formative Res has been accepted for indexing in PubMed Central and PubMed. The staff at PubMed Central is currently finalizing the setup and we expect all articles published since Vol 1 / Iss 1 (2017) to be in PubMed Central and PubMed within the next couple of weeks. The acceptance is the result of a rigorous scientific and technical evaluation by the US National Library's (NLM’s) Library Operations Division, which decided that the scientific and editorial character and quality of a JMIR Formative Research merits its inclusion in PMC. In making this decision NLM has considered the suitability of the journal for the NLM collection as well as the opinions of expert consultants.
JMIR Formative Research (JFR) (a PubMed-indexed sister journal of J Med Internet Res (JMIR) and JMIR mHealth & uHealth, the leading eHealth and mHealth journals by impact factor) publishes peer-reviewed, openly accessible papers containing results from process evaluations, feasibility/pilot studies and other kinds of formative research and preliminary results. While the original focus was on the design of medical and health-related research and technology innovations, JFR publishes studies from all areas of medical and health research.
Formative research is research that occurs before a program is designed and implemented, or while a program is being conducted. Formative research can help
define and understand populations in need of a intervention or public health program
create programs that are specific to the needs of those populations
ensure programs are acceptable and feasible to users before launching
improve the relationship between users and agencies/research groups
demonstrate the feasibility, use, satisfaction with, or problems with a program before large-scale summative evaluation (looking at health outcomes)
Many funding agencies will expect some sort of pilot/feasibility/process evaluation before funding a larger study such as a Randomized Controlled Trial (RCT).
Formative research should be an integral part of developing programs or adapting programs, and should be used while the program is on-going to help refine and improve program activities. Thus, formative evaluation can and should also occur in form of a process evaluation alongside a summative evaluation such as a RCT.
This journal fills an important gap in the academic journals landscape, as it publishes sound and peer-reviewed formative research that is criticial for investigators to apply for further funding, but that is usually not published in outcomes-focussed medical journals aiming for impact and generalizability.
Summative evaluations of programs and apps/software that have undergone a thorough formative evaluation before launch have a better chance to be published in our high-impact flagship journals (JMIR mHealth, J Med Internet Res, JMIR Serious Games), thus we encourage authors to submit - as a first step - their formative evaluations in JMIR Formative Res (and their evaluation protocols in JMIR Res Protoc).
Background:
Accelerometers, often in conjunction with heart rate sensors, are extensively used to track physical activity (PA) in research. Research-grade instruments are often expensive and have limited battery capacity, limited storage, and high participant burden. Consumer-based activity trackers are equipped with similar technology and designed for long-term wear, and can therefore potentially be used in research.
Methods:
A total of 50 participants wore 2 ActiGraphs (wrist and hip), 2 Actihearts (upper and lower chest position), and 1 Polar M430 sport watch for 1 full day. We compared reported time (minutes) spent in sedentary behavior and in light, moderate, vigorous, and moderate to vigorous PA, step counts, activity energy expenditure, and total energy expenditure between devices. We used Pearson correlations, intraclass correlations, mean absolute percentage errors (MAPEs), and Bland-Altman plots to assess criterion validity.
Results:
Pearson correlations between the Polar M430 and all research-grade instruments were moderate or stronger for vigorous PA (r range .59-.76), moderate to vigorous PA (r range .51-.75), steps (r range .85-.87), total energy expenditure (r range .88-.94), and activity energy expenditure (r range .74-.79). Bland-Altman plots showed higher agreement for higher intensities of PA. MAPE was high for most outcomes. Only total energy expenditure measured by the hip-worn ActiGraph and both Actiheart positions had acceptable or close to acceptable errors with MAPEs of 6.94% (ActiGraph, 3 axes), 8.26% (ActiGraph, 1 axis), 14.54% (Actiheart, upper position), and 14.37% (Actiheart, lower position). The wrist-worn ActiGraph had a MAPE of 15.94% for measuring steps. All other outcomes had a MAPE of 22% or higher. For most outcomes, the Polar M430 was most strongly correlated with the hip-worn triaxial ActiGraph, with a moderate or strong Pearson correlation for sedentary behavior (r=.52) and for light (r=.7), moderate (r=.57), vigorous (r=.76), and moderate to vigorous (r=.75) PA. In addition, correlations were strong or very strong for activity energy expenditure (r=.75), steps (r=.85), and total energy expenditure (r=.91).
Conclusions:
The Polar M430 can potentially be used as an addition to established research-grade instruments to collect some PA variables over a prolonged period. However, due to the high MAPE of most outcomes, only total energy expenditure can be trusted to provide close to valid results. Depending on the variable, the Polar M430 over- or underreported most metrics, and may therefore be better suited to report changes in PA over time for some outcomes, rather than as an accurate instrument for PA status in a population.
Background: Mountain biking is an aerobic physical activity that has experienced rapid growth. The emergence of the electric pedal-assist mountain bike (eMTB), while not without its critics, presents the potential for an even larger segment of the population to enjoy the health benefits of mountain biking. Although the research focused on the use of e-bikes generally is growing, there is limited research specifically targeting eMTB use. Research is needed exploring the potential exercise response of riding an eMTB, together with the beliefs and perceptions of mountain bikers who have and have not experienced eMTB riding. Objective: This study aimed to compare conventional mountain bike and eMTB use. This was done by investigating 2 questions: (1) What proportion of exercise response is retained for an experienced mountain biker while using an eMTB when compared with a conventional mountain bike? and (2) What are the perceptions and beliefs of experienced mountain bikers toward eMTBs both before and after riding an eMTB? Methods: A convergent mixed methods data collection approach was used in the study. Participants completed both a pre- and postride questionnaire, and data regarding heart rate were collected. Heart rates from each ride were compared against each other. Results: The average heart rate during eMTB use was 94% (31/33) of the average heart rate during conventional mountain bike use. Therefore, eMTB use in this study achieved a majority of the exercise response and exceeded established biometric thresholds for cardiovascular fitness. Paired t test statistics were calculated to compare beliefs of conventional mountain bikes and eMTBs and to compare mean heart rate and speed between conventional mountain bike and eMTB use on the study loop. Participants overwhelmingly perceived the potential impact of eMTB use to be positive on both pre- and post-eMTB ride questionnaires. Conclusions: Despite the measured benefit, participants’ perceived exertion while riding the eMTB was low.
Background: Although we know that many young people watch online pornography and engage in sexting, there is limited literature examining their needs in relation to information on these highly sensitive and complex issues. Online resources exist; however, we can find no evidence of any of them having been formally tested for usability within the target population. Objective: This study aimed to test the usability of a resource about online pornography and sexting among young people. Methods: Semistructured interviews were conducted with 17 participants aged 15 to 29 years. Results: We found that the SCOPE resource was perceived as trustworthy and credible because of its evidence-based content, nonjudgmental tone, and balanced perspectives. Multimedia and video content enhanced the layout and usability of the resource; however, content relevance could be improved by targeting age and developmental stages. Participants identified resource sections such as Real Stories from young people as relevant and engaging. However, they raised issues with the translation of formative research findings relating to these stories into their final presentation. Conclusions: Our findings suggest that young people prefer online resources about complex issues, such as online pornography and sexting, if they are balanced in content and tone. Most importantly, in the context of responding to complex and sensitive issues such as these, co-design methods can ensure that young people are central to the development of resources and avoid gaps in translating research into practice. In the context of limited literature focusing on the usability of online resources about these topics, this paper provides important insights for public health practitioners working in this emerging space.
Background: An estimated one in eight cervical cancer cases are due to a lack of follow-up care for abnormal Pap test results. Low rates of completion of follow-up care particularly affect low-income minority women. The burden of cervical cancer could be reduced through interventions that improve timely colposcopy follow-up and treatment of abnormal screening results. Mobile communications via text messaging present a low-cost opportunity to increase rates of clinic return among women referred to follow-up after obtaining abnormal screening results. Objective: Our aims were to determine the acceptability and feasibility of using text messaging to increase completion of follow-up care following abnormal cervical cancer screening (Pap test) results and to examine factors that may affect the acceptability and use of text messaging to increase communications between health care providers (HCP) and low-income minority women. Methods: The study participants were 15 low-income women who had undergone a Pap test within the preceding 12 months. Semistructured interviews, including open- and closed-ended questions from a validated questionnaire, were conducted by phone or in person. Responses to closed-ended survey items were tabulated, and descriptive statistics were generated using Microsoft Excel. Responses to the open-ended questions were coded and analyzed using NVivo 11 qualitative analysis software. Results: Nearly all participants (14/15, 93%) were comfortable receiving a text message from an HCP stating that their Pap test results were available (<40 years: 100%; ≥40 years: 86%). Over half (8/15; 53%) of the participants were comfortable receiving a text message stating that their Pap test results were abnormal, although many preferred to receive such information via a phone call (6/15; 40%). Most participants (9/15; 60%) believed that receiving a text reminder would make them more likely to attend their appointment. The preferred method for receiving a reminder appeared to vary by age, with older women preferring telephone reminders over text messaging reminders. Analysis of open-ended questions suggested that text messaging appeals to some women due to its wide use and convenience for communicating with HCPs. However, women cited concerns about the confidentiality of messages and barriers to understanding the messages, including the physical capacity to read and accurately interpret the content of the messaging. Conclusions: Most participants indicated a willingness to receive text messages from their HCPs about cervical cancer screening results and believed that text messages were the best way to remind them of appointments for follow-up care. Potential concerns could be addressed by excluding explicit references to the nature of the appointment in the text message in order to avoid disclosure of sensitive health information to unauthorized individuals. Although text messaging seems promising to improve adherence to timely follow-up, personal preferences should be considered by allowing patients to opt-out of text communications.
Background: Injury data and reports provide valuable information for both public and private organizations to guide programming, policy, and prevention, but in the increasingly complex and dangerous industry of US agriculture, the injury surveillance needed to produce this data is lacking. To address the gap, AgInjuryNews was established in 2015. The system includes fatal and nonfatal injury cases derived from publicly available reports, including occupational and nonoccupational injuries, occurring in the agricultural, forestry, and fishing (AFF) industry. Objective: The study aimed to develop a stakeholder-engaged redesign of the interactive, up-to-date, and publicly available dataset of US AFF injury and fatality reports. Methods: Instructor-led heuristic evaluations within a 15-student undergraduate course, data from 8 student participants of laboratory-based usability testing and 2016 and 2017 AgInjuryNews-registered user surveys, coupled with input from the National Steering Committee informed the development priorities for 2018. An interdisciplinary team employed an agile methodology of 2-week sprints developing in ASP.NET and Structured Query Language to deliver an intuitive frontend and a flexible, yet structured, backend, including a case report input form for capturing more than 50 data points on each injury report. Results: AgInjuryNews produced 17,714 page views from 43 countries in 2018 captured via Google Analytics, whereas 623 injury reports were coded and loaded, totaling more than 31,000 data points. Newly designed features include customizable email alerts, an interactive map, and expanded search and filter options. User groups such as the Bureau of Labor Statistics and the Agricultural Safety and Health Council of America have endorsed the system within their networks. News media have cited or referenced the system in national outlets such as the New York Times, Politico, and the Washington Post. Conclusions: The new system’s features, functions, and improved data granularity have sparked innovative lines of research and increased collaborative interest domestically and abroad. It is anticipated that this nontraditional sentinel surveillance system and its dataset will continue to serve many purposes for public and private agricultural safety and health stakeholders in the years to come.
Background: Persistent cognitive impairment is prevalent in unipolar and bipolar disorders and is associated with decreased quality of life and psychosocial dysfunction. The screen for cognitive impairment in psychiatry (SCIP) test is a validated paper-and-pencil instrument for the assessment of cognition in affective disorders. However, there is no digital cognitive screening tool for the brief and accurate assessment of cognitive impairments in this patient group. Objective: In this paper, we present the design process and feasibility study of the internet-based cognitive assessment tool (ICAT) that is designed based on the cognitive tasks of the SCIP. The aims of this feasibility study were to perform the following tasks among healthy individuals: (1) evaluate the usability of the ICAT, (2) investigate the feasibility of the ICAT as a patient-administered cognitive assessment tool, and (3) examine the performance of automatic speech recognition (ASR) for the assessment of verbal recall. Methods: The ICAT was developed in a user-centered design process. The cognitive measures of the ICAT were immediate and delayed recall, working memory, and psychomotor speed. Usability and feasibility studies were conducted separately with 2 groups of healthy individuals (N=21 and N=19, respectively). ICAT tests were available in the English and Danish languages. The participants were asked to fill in the post study system usability questionnaire (PSSUQ) upon completing the ICAT test. Verbal recall in the ICAT was assessed using ASR, and the performance evaluation criterion was word error rate (WER). A Pearson 2-tailed correlation analysis significant at the .05 level was applied to investigate the association between the SCIP and ICAT scores. Results: The overall psychometric factors of PSSUQ for both studies gave scores above 4 (out of 5). The analysis of the feasibility study revealed a moderate to strong correlation between the total scores of the SCIP and ICAT (r=0.63; P=.009). There were also moderate to strong correlations between the SCIP and ICAT subtests for immediate verbal recall (r=0.67; P=.002) and psychomotor speed (r=0.71; P=.001). The associations between the respective subtests for working memory, executive function, and delayed recall, however, were not statistically significant. The corresponding WER for English and Danish responses were 17.8% and 6.3%, respectively. Conclusions: The ICAT is the first digital screening instrument modified from the SCIP using Web-based technology and ASR. There was good accuracy of the ASR for verbal memory assessment. The moderate correlation between the ICAT and SCIP scores suggests that the ICAT is a valid tool for assessing cognition, although this should be confirmed in a larger study with greater statistical power. Taken together, the ICAT seems to be a valid Web-based cognitive assessment tool that, after some minor modifications and further validation, may be used to screen for cognitive impairment in clinical settings.
Background: The population with a spinal cord injury (SCI) largely remains inactive following discharge from rehabilitation despite evidence on the benefits of physical activity. These individuals need to develop skills to self-manage their condition in order to prevent secondary comorbidities and rehospitalization. A Web-based physical activity portal can address this need. Few Web-based interventions incorporate theoretical frameworks, behavior change techniques, and modes of delivery into their design. Objective: This study aimed to identify the preferred features of a Web-based self-management physical activity portal through stakeholder engagement with individuals with a spinal cord injury and health care professionals (HCPs). Methods: An interpretative phenomenology methodology and participatory design, along with an integrated knowledge translation approach, were used to conduct this study. Convenience sampling was used to recruit individuals with an SCI living in the community, who were either interested or already engaging in physical activity, and HCPs working with individuals with an SCI, from three city-based rehabilitation sites. Individual 1-hour sessions involving navigation of an existing website and a semistructured interview were conducted with all participants. Individuals with an SCI completed a demographics questionnaire prior to the individual sessions, while demographic information of the HCPs was collected during their interviews. Additionally, all participants were asked a question on their intention to use or recommend a portal. An in-depth thematic analysis was used to derive themes from participants’ responses. Results: Thirteen individuals with an SCI and nine HCPs participated in the study. Five core themes emerged: (1) knowledge: guidance and barrier management; (2) possibility of achievement: the risks and benefits of physical activity and modelling; (3) self-regulation strategies: action planning, goal setting, tracking, rewards, and reminders; (4) interactivity: peers and professionals; and (5) format: appearance, language, and ease of use. The mean (median) ratings of the likelihood of promoting and using a Web-based portal tailored to individuals’ needs were 9.00 (8.78) and 7.75 (7.88) for HCPs and individuals with an SCI, respectively. Conclusions: This study highlights features of an online self-management platform that can provide individuals with an SCI the motivation and volition to engage in physical activity. These findings will inform the design of a Web-based self-management physical activity portal to increase physical activity adherence and behavior change.
Background: The unprecedented number of youths engaged in nonmedical use of prescription opioids (POs), as well as the myriad negative consequences of such misuse, emphasizes the importance of prevention efforts targeting this public health crisis. Although there are several science-based, interactive drug abuse prevention programs focused on preventing the use of nonprescription drugs in youths, to our knowledge, there are no science-based interactive programs that focus on the prevention of PO abuse among adolescents. Objective: The aim of this study was to develop and conduct a formative evaluation of a science-based interactive Web-based program focused on the prevention of PO abuse among adolescents aged 12 to 17 years (Pop4Teens). This study was conducted to prepare for a randomized controlled trial designed to evaluate the effectiveness of Pop4Teens compared with an active control website, JustThinkTwice.com (Drug Enforcement Administration), in impacting knowledge and attitudes about POs and perceptions of risk associated with the abuse of POs, as well as intentions to use and actual use of POs. Methods: We conducted 6 focus groups with 30 youths (a mean of 5 per group: the eligibility being aged 12-19 years) along a continuum of exposure to POs (in treatment for opioid use disorder, in general treatment for other substance use disorder, prescribed an opioid, and opioid-naïve) and writing sessions with 30 youths in treatment for opioid use disorder (12-19 years) to inform the development of the Web-based prevention tool. Feasibility and acceptability of a prototype of the Web-based intervention were then assessed through individual feedback sessions with 57 youths (drawn from the same populations as the focus groups). Results: We successfully completed the development of a Web-based PO abuse prevention program (Pop4Teens). Analyses of focus group transcripts informed the development of the program (eg, quiz content/format, script writing, and story editing). Selected writing session narratives anchored the planned scientific content by lending credibility and informing the development of compelling storylines intended to motivate the youth to engage with the program. Feedback session data indicated that the Web-based tool could be potentially useful and acceptable. In addition, feedback session participants demonstrated significant increases in their knowledge of key topics related to the prevention of PO abuse after the exposure to sections of the Web-based program. Conclusions: The opioid crisis is predicted to get worse before it gets better. An effective response will likely require a multipronged strategy inclusive of effective evidence-based prevention programs acceptable to, and accessible by, a majority of youths.
Background: The widespread availability and cost-effectiveness of new-wave software-based audience response systems (ARSs) have expanded the possibilities of collecting health data from hard-to-reach populations, including youth. However, with all survey methods, biases in the data may exist because of participant nonresponse. Objective: The aims of this study were to (1) examine the extent to which an ARS could be used to gather health information from youths within a large-group school setting and (2) examine individual- and survey-level response biases stemming from this Web-based data collection method. Methods: We used an ARS to deliver a mental health survey to 3418 youths in 4 high schools in the Midwestern United States. The survey contained demographic questions, depression, anxiety, and suicidality screeners, and questions about their use of offline resources (eg, parents, peers, and counselors) and Web-based resources (ie, telemental health technologies) when they faced stressful life situations. We then examined the response rates for each survey item, focusing on the individual- and survey-level characteristics that related to nonresponse. Results: Overall, 25.39% (868/3418) of youths answered all 38 survey questions; however, missingness analyses showed that there were some survey structure factors that led to higher rates of nonresponse (eg, questions at the end of survey, sensitive questions, and questions for which precise answers were difficult to provide). There were also some personal characteristics that were associated with nonresponse (eg, not identifying as either male or female, nonwhite ethnicity, and higher levels of depression). Specifically, a multivariate model showed that male students and students who reported their gender as other had significantly higher numbers of missed items compared with female students (B=.30 and B=.47, respectively, P<.001). Similarly, nonwhite race (B=.39, P<.001) and higher depression scores (B=.39, P<.001) were positively related to the number of missing survey responses. Conclusions: Although our methodology-focused study showed that it is possible to gather sensitive mental health data from youths in large groups using ARSs, we also suggest that these nonresponse patterns need to be considered and controlled for when using ARSs for gathering population health data.
Background: As a result of advances in diagnostic testing in the field of Alzheimer disease (AD), patients are diagnosed in earlier stages of the disease, for example, in the stage of mild cognitive impairment (MCI). This poses novel challenges for a clinician during the diagnostic workup with regard to diagnostic testing itself, namely, which tests are to be performed, but also on how to engage patients in this decision and how to communicate test results. As a result, tools to support decision making and improve risk communication could be valuable for clinicians and patients. Objective: The aim of this study was to present the design, development, and testing of a Web-based tool for clinicians in a memory clinic setting and to ascertain whether this tool can (1) facilitate the interpretation of biomarker results in individual patients with MCI regarding their risk of progression to dementia, (2) support clinicians in communicating biomarker test results and risks to MCI patients and their caregivers, and (3) support clinicians in a process of shared decision making regarding the diagnostic workup of AD. Methods: A multiphase mixed-methods approach was used. Phase 1 consisted of a qualitative needs assessment among professionals, patients, and caregivers; phase 2, consisted of an iterative process of development and the design of the tool (ADappt); and phase 3 consisted of a quantitative and qualitative assessment of usability and acceptability of ADappt. Across these phases, co-creation was realized via a user-centered qualitative approach with clinicians, patients, and caregivers. Results: In phase 1, clinicians indicated the need for risk calculation tools and visual aids to communicate test results to patients. Patients and caregivers expressed their needs for more specific information on their risk for developing AD and related consequences. In phase 2, we developed the content and graphical design of ADappt encompassing 3 modules: a risk calculation tool, a risk communication tool including a summary sheet for patients and caregivers, and a conversation starter to support shared decision making regarding the diagnostic workup. In phase 3, ADappt was considered to be clear and user-friendly. Conclusions: Clinicians in a memory clinic setting can use ADappt, a Web-based tool, developed using multiphase design and co-creation, for support that includes an individually tailored interpretation of biomarker test results, communication of test results and risks to patients and their caregivers, and shared decision making on diagnostic testing.
Background: Data on contraceptive needs and use among young unmarried men are limited. Conventional ways of data collection may lead to limited and unreliable information on contraceptive use due to sensitivity of the topic, as many young men feel ashamed to discuss their behavior of using contraceptives. As short message service (SMS) is anonymous and a commonly used means of communication, we believe that if deployed, it will create a promising user-friendly method of data collection. Objective: The objective was to investigate the feasibility of using SMS to collect data on sexually active, young, unmarried men’s sexual behavior and contraceptive preferences, practices, and needs in Addis Ababa, Ethiopia, and Moshi, Tanzania. Methods: We enrolled men aged 18-30 years who were students (in Ethiopia and Tanzania), taxi or local bus drivers/assistants (Ethiopia and Tanzania), Kilimanjaro porters (Tanzania), or construction workers (Ethiopia). Young men were interviewed using a topic list on contraceptive use. They were followed up for 6 months by sending fortnightly SMS texts with questions about contraceptive use. If the young men indicated that they needed contraceptives during the reporting period or were not satisfied with the method they used, they were invited for a follow-up interview. At the end of the study, we conducted exit interviews telephonically using a semistructured questionnaire to explore the feasibility, acceptability, and accuracy of using SMS to validate the study findings in both countries. Results: We enrolled 71 young unmarried men—35 in Tanzania and 36 in Ethiopia. In Moshi, 1908 messages were delivered to participants and 1119 SMS responses were obtained. In Ethiopia, however, only 525 messages were sent to participants and 248 replies were received. The question on dating a girl in the past weeks was asked 438 times in Tanzania and received 252 (58%) replies, of which 148 (59%) were “YES.” In Ethiopia, this question was asked 314 times and received 64 (20%) replies, of which 52 (81%) were “YES” (P=.02 for difference in replies between Tanzania and Ethiopia). In Tanzania, the question on contraceptive use was sent successfully 112 times and received 108 (96%) replies, of which 105 (94%) were “YES.” In Ethiopia, the question on contraceptive use was asked 17 times and received only 2 (11%) replies. Exit interviews in Tanzania showed that SMS was accepted as a means of data collection by 22 (88%) of the 25 interviewed participants. Conclusions: Despite network and individual challenges, the SMS system was found to be feasible in Moshi, but not in Addis Ababa. We recommend more research to scale up the method in different groups and regions.
Background: As many as 50% of people experience medication nonadherence, yet studies for detecting nonadherence and delivering real-time interventions to improve adherence are lacking. Mobile health (mHealth) technologies show promise to track and support medication adherence. Objective: The study aimed to evaluate the feasibility and acceptability of using an mHealth system for medication adherence tracking and intervention delivery. The mHealth system comprises a smart button device to self-track medication taking, a companion smartphone app, a computer algorithm used to determine adherence and then deliver a standard or tailored SMS (short message service) text message on the basis of timing of medication taking. Standard SMS text messages indicated that the smartphone app registered the button press, whereas tailored SMS text messages encouraged habit formation and systems thinking on the basis of the timing the medications were taken. Methods: A convenience sample of 5 adults with chronic kidney disease (CKD), who were prescribed antihypertensive medication, participated in a 52-day longitudinal study. The study was conducted in 3 phases, with a standard SMS text message sent in phases 1 (study days 1-14) and 3 (study days 46-52) and tailored SMS text messages sent during phase 2 (study days 15-45) in response to participant medication self-tracking. Medication adherence was measured using: (1) the smart button and (2) electronic medication monitoring caps. Concordance between these 2 methods was evaluated using percentage of measurements made on the same day and occurring within ±5 min of one another. Acceptability was evaluated using qualitative feedback from participants. Results: A total of 5 patients with CKD, stages 1-4, were enrolled in the study, with the majority being men (60%), white (80%), and Hispanic/Latino (40%) of middle age (52.6 years, SD 22.49; range 20-70). The mHealth system was successfully initiated in the clinic setting for all enrolled participants. Of the expected 260 data points, 36.5% (n=95) were recorded with the smart button and 76.2% (n=198) with electronic monitoring. Concordant events (n=94), in which events were recorded with both the smart button and electronic monitoring, occurred 47% of the time and 58% of these events occurred within ±5 min of one another. Participant comments suggested SMS text messages were encouraging. Conclusions: It was feasible to recruit participants in the clinic setting for an mHealth study, and our system was successfully initiated for all enrolled participants. The smart button is an innovative way to self-report adherence data, including date and timing of medication taking, which were not previously available from measures that rely on recall of adherence. Although the selected smart button had poor concordance with electronic monitoring caps, participants were willing to use it to self-track medication adherence, and they found the mHealth system acceptable to use in most cases.
Background: The NHS’ ‘Long term plan’ details plans to make digital interactions available to all patients in five years. Teleconsultations can improve access to specialist services however ther...
Background: The NHS’ ‘Long term plan’ details plans to make digital interactions available to all patients in five years. Teleconsultations can improve access to specialist services however there is a lack of UK evidence for the use of teleconsultations in an Oncology setting. Here we describe a service evaluation of teleconsultations for patients attending a regional brain metastases (BM) clinic. These patients have unique travel restrictions that prevent them from driving. Objective: To assess the feasibility and acceptability of a teleconsultation service in this setting. Methods: From April 2018 to October 2018 all patients attending the BM clinic were offered the choice of a teleconsultation in place of a face-to-face appointment. Feedback was assessed using a satisfaction questionnaire and data was collected on all clinic attendances. Results: Sixty-nine individual patients had 119 appointments over the duration of the pilot. Of these, 36 were new patient appointments and 73 were follow ups. Of these, 24 patients (35%) took part in 41 (34%) teleconsultations. User satisfaction was high and no patients who took part in a teleconsultation reverted to face-to-face appointments. These patients avoided 2521 miles (61.6 miles per appointment) of hospital associated travel and travel costs of £441.48 (£10.78 per appointment). Conclusions: Teleconsultations appear to be acceptable in this cohort of patients who have brain metastases attending a regional stereotactic radiosurgery service with the potential for significant savings in travel and expenses evident.
Background: Pulmonary rehabilitation (PR) is an effective intervention for the management of people with chronic respiratory diseases but uptake of and adherence to PR programs is low. There is potent...
Background: Pulmonary rehabilitation (PR) is an effective intervention for the management of people with chronic respiratory diseases but uptake of and adherence to PR programs is low. There is potential for mobile health (mHealth) to provide an alternative modality for the delivery of PR, overcoming many of the barriers contributing to poor attendance to current services. Objective: This study aims to understand the needs, preferences and priorities of end-users for the development of an adaptive mHealth PR support intervention. Methods: A mixed methods (qualitative and quantitative) approach was used to assess the needs, preferences and priorities of end users (i.e. patients with chronic respiratory disorders) and key stakeholders (i.e. clinicians working with patients with chronic respiratory disorders and running PR). The formative studies included: (1) A survey to understand the preferences and priorities of patients for PR and how mobile technology can be used to provide PR support, (2) Ethnographic semi-structured interviews with patients with chronic respiratory disorders to gain perspectives on their understanding of their health and potential features that could be included in a mobile PR intervention and (3) Key informant interviews with healthcare providers to understand the needs, preferences and priorities for the development of an mHealth PR support intervention. Results: Across all formative studies (patient survey (n=30), patient interviews (n=8) and key stakeholder interviews (n=8)) participants were positive about the idea of a mobile PR program but raised concerns related to digital literacy and confidence in using technology, access to technology, as well as loss of social support currently gained from traditional programs. Key stakeholders highlighted the need for patient safety to be maintained and ensuring appropriate programs for different groups within the population. Finding a balance between ensuring safety and maximizing access was seen to be essential in the success of a mobile PR program. Conclusions: These formative studies found high interest in mHealth based PR intervention and detailed the potential for a mobile PR program to overcome current barriers to accessing traditional PR programs. Key considerations and features were identified including the importance of technology access and digital literacy being considered in utilizing technology with this population.
Background: The REDUCE-RISK trial (ClinicalTrials.gov Identifier: NCT02852694) is set up to compare the effectiveness of weekly subcutaneously administered methotrexate with daily oral azathioprine/6-...
Background: The REDUCE-RISK trial (ClinicalTrials.gov Identifier: NCT02852694) is set up to compare the effectiveness of weekly subcutaneously administered methotrexate with daily oral azathioprine/6-mercaptopurine in low risk Crohn’s disease (CD) or subcutaneously administered adalimumab in high risk CD in a paediatric population (age 6-17). Objective: A systematic economic literature review was performed to provide input to the research protocol in order to gather the necessary information to allow the performance of an evidence-based economic evaluation when the trial is finished. Methods: A) Data sources: The Centre for Reviews and Dissemination (CRD) Health Technology Assessment (HTA) database, websites of HTA institutes, CRD’s National Health Service Economic Evaluation Database (NHS EED), Medline (OVID), and EMBASE databases were consulted to retrieve (reviews of) relevant economic evaluations. B) Eligibility criteria: Studies were eligible if they included a paediatric or adult population with inflammatory bowel diseases (Crohn’s disease (CD) and ulcerative colitis (UC)) treated with adalimumab (Humira®). There were no restrictions for the comparator. Only economic evaluations expressing outcomes in life-years gained or quality-adjusted life years gained were selected. Results: Twelve primary studies were identified. None of these studies included a paediatric population due to a lack of supporting trials. The economic evaluations identified in our systematic review indicate adalimumab is an appropriate intervention for inclusion in such a trial. From a health economic point of view, it is important to make an incremental analysis comparing such an intervention with standard care, and not immediately versus another (expensive) biological treatment. Information on the impact of children’s school attendance and parents’ productivity is currently lacking in the economic evaluations and none of the underlying trials measured QoL with a generic utility instrument. Conclusions: The review of the economic literature of adalimumab for the treatment of patients with CD supports the performance of a trial with biologicals in paediatric patients, including making a distinction according to severity of disease. Carrying out an economic literature review has allowed us to decide which variables should be added to the research protocol from an economic point of view. Measurements for children’s and parents’ quality of life (EQ-5D questionnaires), children’s school attendance and parents’ productivity (WPAI-CD-CG questionnaire) were added to the research protocol. This will provide support for the calculation of the cost-effectiveness of the interventions evaluated in the REDUCE-RISK trial. Clinical Trial: ClinicalTrials.gov Identifier: NCT02852694
