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JMIR Formative Research
Process evaluations, early results and feasibility/pilot studies of digital and non-digital interventions
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.
(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: 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: Virtual reality (VR) technology is not currently used in the treatment of severe mental health illness in Norway. Objective: We aimed to explore the potential of VR as a treatment for severe mental health illness in Norway, through collaborative research between clinicians and researchers. Methods: A collaborative research team was established, comprising researchers, the manager at a district psychiatric center, and the manager of the local municipal mental health service. An all-day workshop with eight clinicians—four from specialist mental health services and four from municipal mental health services—was conducted. The clinicians watched three different VR movies and after each one, they answered predefined questions designed to reflect their immediate thoughts about VR’s potential use in clinical practice. At the end of the workshop, two focus group interviews, each with four clinicians from each service level, were conducted. Results: VR technology in specialist services might be a new tool for the treatment of severe mental health illness. In municipal mental health services, VR might particularly be useful in systematic social training that would otherwise take a very long time to complete. Conclusions: We found substantial potential for the use of VR in the treatment of severe mental health illness in specialist and municipal mental health services. One of the uses of VR technology with the greatest potential was helping individuals who had isolated themselves and needed training in social skills and everyday activity to enable them to have more active social lives. VR could also be used to simulate severe mental illness to provide a better understanding of how the person with severe mental illness experiences their situation.
Background: Social network sites (SNSs) have been defined as Web services that involve creating a private or semiprivate profile. Through these services, adolescents and adults can maintain and create new relationships. Adolescents, in particular, can be considered the main users of these sites as they spend a lot of time on SNSs. In using SNSs, individuals can exert greater control over the conversation and on the information shared, which is associated with a desire for self-presentation. Moreover, the need for self-presentation is related to personality traits such as those of the Big Five, namely extraversion, neuroticism, openness to experience, agreeableness, and conscientiousness, as well as emotional stability, introversion, narcissism, and motivational aspects. The latter are usually linked to an underlying social purpose that might predispose an individual to using SNSs, with the intent of satisfying particular needs, such as belongingness and interpersonal competency. Objective: Using the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) method, this study aimed to present a systematic review of the scientific literature regarding the predisposing factors related to the Big Five personality traits and motivational aspects associated with the use of SNSs, for both adolescents (12-19 years) and adults (>20 years). Methods: A search ranging from 2007 to 2017 was conducted through the academic database of Google Scholar and PsycINFO, in which the following terms and their derivatives were considered: predisposing factors, personality traits, Big Five model, self-esteem, self-presentation, interpersonal competency, social network site, Facebook, motivation, five-factor model, use, abuse, and addiction. Based on a defined list of inclusion and exclusion criteria, a total of 9 papers were finally included in the review. Results: Our findings identified 3 main personality traits to be of greater value: extraversion, neuroticism, and openness to experience. Extraversion was a good predictor of motivation and SNS use, whereas the latter trait showed relevance for age differences. All 3 features further played a role in gender differences. Apart from extraversion, the self-presentational motive was also related to narcissism, whereas the need to belong presented an association with agreeableness and neuroticism. Further underlining the social value behind SNS use, people perceived interpersonal competency as being related to Facebook use intensity. Conclusions: Extraversion was recognized as the main forerunner for SNS use and motivation for use. Neuroticism seems to be related to an attempt at compensating for difficulties in real-life social contexts. Openness to experiences has a strong valence for both adults and older adults since SNSs are still perceived as a novelty. Moreover, gender differences in SNS usage were observed to be the product of differences in motivation. Implications and limitations of the study were discussed.
Background: Patient-centered care—that is, care tailored to personal wishes and needs of patients—has become increasingly important. It is especially relevant in health care areas where patients suffer from a high burden of disease, such as fertility care. At present, both diagnosis and treatment for infertile couples is provided at a single hospital. As a consequence, patients are not likely to receive optimal, independent advice regarding their fertility problems. Internet-based, independent advice could be feasible for large groups of patients because it is not limited by travel distance and overhead costs. Objective: The aim of this study was to explore the experiences of both patients and professionals with an online platform using video consultations for patients with infertility seeking independent advice for their fertility problem. Methods: This pilot study evaluated an online platform, Fertility Consult, where patients with infertility can get independent advice by a gynecologist through a video consultation, thus eliminating the need of meeting the doctor physically. Semistructured interviews were performed with 2 gynecologists and the chairman of the Dutch patients association. This information was used for a patients’ questionnaire about their first experiences with Fertility Consult, including questions about the level of patient-centeredness and shared decision making, using the Patient-Centered Questionnaire-Infertility (PCQ-Infertility) and the CollaboRATE questionnaire, respectively. Results: Of the first 27 patients enrolled at Fertility Consult, 22 responded (82%). Most patients (82%) visited Fertility Consult for a second opinion, seeking more personal attention and independent advice. The mean level of patient-centeredness on the PCQ-Infertility questionnaire was 2.78 (SD 0.58) on a scale of 0 to 3. For the CollaboRATE questionnaire (scale 0-9), patients provided a median score of 8.0 (range 7-9) on all 3 questions about shared decision making. Conclusions: Patients were satisfied with independent, well-prepared, Web-based advice; health care professionals felt they were able to provide patients with proper advice in a manner befitting patients’ needs, without any loss of quality. Future studies should focus more on the separation of advice and treatment and on Web-based consultations compared with face-to-face consultations to ascertain the possibility of increased patient involvement in the process to improve the level of patient-centered care.
Background: There is an increasing need for peer workers (people with lived experience of mental health problems who support others) to work alongside consumers to improve recovery and outcomes. In addition, new forms of technology (tablet or mobile apps) can deliver services in an engaging and innovative way. However, there is a need to evaluate interventions in real-world settings. Objective: This exploratory proof-of-concept study aimed to determine if a peer worker–led electronic mental health (e-mental health) recovery program is a feasible, acceptable, and effective adjunct to usual care for people with moderate-to-severe mental illness. Methods: Overall, 6 consumers and 5 health service staff participated in the evaluation of a peer-led recovery app delivered at a community-based public mental health service. The peer worker and other health professional staff invited attendees at the drop-in medication clinics to participate in the trial during June to August 2017. Following the intervention period, participants were also invited by the peer worker to complete the evaluation in a separate room with the researcher. Consumers were explicitly informed that participation in the research evaluation was entirely voluntary. Consumer evaluation measures at postintervention included recovery and views on the acceptability of the program and its delivery. Interviews with staff focused on the acceptability and feasibility of the app itself and integrating a peer worker into the health care service. Results: Consumer recruitment in the research component of the study (n=6) fell substantially short of the target number of participants (n=30). However, from those who participated, both staff and consumers were highly satisfied with the peer worker and somewhat satisfied with the app. Health care staff overall believed that the addition of the peer worker was highly beneficial to both the consumers and staff. Conclusions: The preliminary findings from this proof-of-concept pilot study suggest that a peer-led program may be a feasible and acceptable method of working on recovery in this population. However, the e-mental health program did not appear feasible in this setting. In addition, recruitment was challenging in this particular group, and it is important to note that these study findings may not be generalizable. Despite this, ensuring familiarity of technology in the target population before implementing e-mental health interventions is likely to be of benefit.
Background: Despite renewed focus on biomedical prevention strategies since the publication of several clinical trials highlighting the efficacy of pre-exposure prophylaxis (PrEP), knowledge of postexposure prophylaxis (PEP) and PrEP continues to remain scarce among women, especially among African American women who are disproportionally affected by HIV. In an effort to address this barrier and encourage uptake of PEP and PrEP, an electronic health (eHealth) video was created using an entertainment-education format. Objective: The study aimed to explore the feasibility, acceptability, and preference of an avatar-led, eHealth video, PEP and PrEP for Women, to increase awareness and knowledge of PEP and PrEP for HIV in a sample of African American women. Methods: A cross-sectional, Web-based study was conducted with 116 African American women aged 18 to 61 years to measure participants’ perceived acceptability of the video on a 5-point scale: poor, fair, good, very good, and excellent. Backward stepwise regression was used to the find the outcome variable of a higher rating of the PEP and PrEP for Women video. Thematic analysis was conducted to explore the reasons for recommending the video to others after watching the eHealth video. Results: Overall, 89% of the participants rated the video as good or higher. A higher rating of the educational video was significantly predicted by: no current use of drugs/alcohol (beta=−.814; P=.004), not having unprotected sex in the last 3 months (beta=−.488; P=.03), higher income (beta=.149; P=.03), lower level of education (beta=−.267; P=.005), and lower exposure to sexual assault since the age of 18 years (beta=−.313; P=.004). After watching the eHealth video, reasons for recommending the video included the video being educational, entertaining, and suitable for women. Conclusions: Utilization of an avatar-led eHealth video fostered education about PEP and PrEP among African American women who have experienced insufficient outreach for biomedical HIV strategies. This approach can be leveraged to increase awareness and usage among African American women.
Background: Telemedicine draws on information technologies in order to enable the delivery of clinical health care from a distance. Twitter is a social networking platform that has 316 million monthly active users with 500 million tweets per day; its potential for real-time monitoring of public health has been well documented. There is a lack of empirical research that has critically examined the potential of Twitter polls for providing insight into public health. One of the benefits of utilizing Twitter polls is that it is possible to gain access to a large audience that can provide instant and real-time feedback. Moreover, Twitter polls are completely anonymized. Objective: The overall aim of this study was to develop and disseminate Twitter polls based on existing surveys to gain real-time feedback on public views and opinions toward telemedicine. Methods: Two Twitter polls were developed utilizing questions from previously used questionnaires to explore acceptance of telemedicine among Twitter users. The polls were placed on the Twitter timeline of one of the authors, which had more than 9300 followers, and the account followers were asked to answer the poll and retweet it to reach a larger audience. Results: In a population where telemedicine was expected to enjoy big support, a significant number of Twitter users responding to the poll felt that telemedicine was not as good as traditional care. Conclusions: Our results show the potential of Twitter polls for gaining insight into public health topics on a range of health issues not just limited to telemedicine. Our study also sheds light on how Twitter polls can be used to validate and test survey questions.
Background: There is a lack of research on how to best incorporate home-based self-measured blood pressure (SMBP) measurements, combined with other patient-generated health data (PGHD), into electronic health record (EHR) systems in a way that promotes primary care workflow without burdening the primary care team with irrelevant or superfluous data. Objective: The purpose of this study was to explore the perspectives of primary care providers in utilizing SMBP measurements and integrating SMBP data into the clinical workflow for the management of hypertension in the primary care setting. Methods: A total of 13 primary care physicians were interviewed in total; 5 in individual interviews and 8 in a focus group. The interview questions were centered on (1) the value of SMBP in hypertension care, (2) needs of viewing SMBP and desired visual display, (3) desired alert algorithm and critical values, (4) needs for other PGHD, and (5) workflow of primary care team in utilizing SMBP. The interviews were audiotaped and transcribed verbatim, and a thematic analysis was performed to extract overarching themes. Results: The primary care experience of the 13 providers ranged from 5 to 35 years. The following themes emerged from the individual and focus group interviews: (1) ways to utilize SMBP measurements in primary care, (2) preferred visual display of SMBP, (3) patient condition determines preferred scheduling of patient SMBP measurements and provider’s preferred frequency of viewing SMBP data, (4) effect of patient condition on alert parameters, (5) location to receive critical value alerts, (6) primary recipient of critical value alerts, and (7) the need of additional PGHD (eg, emotional stressors, food diary, and medication adherence) to provide context of SMBP values. Conclusions: The perspectives of primary care providers need to be incorporated into the design of a built-in interface in the EHR to incorporate SMBP and other PGHD. Future usability evaluation should be conducted with mock-up interfaces to solicit opinions on the optimal alert frequency and mechanism to best fit the workflow in the primary care setting. Future studies should examine how the utilization of a built-in interface that fully integrates SMBP measurements and PGHD into EHR systems can support patient self-management and thus, improve patient outcomes.
Background: Fatigue is one of the most common and debilitating symptoms of multiple sclerosis (MS) and is the main reason why people with MS stop working early. The MS Society in the United Kingdom funded a randomized controlled trial of FACETS—a face-to-face group-based fatigue management program for people with multiple sclerosis (pwMS)—developed by members of the research team. Given the favorable trial results and to help with implementation, the MS Society supported the design and printing of the FACETS manual and materials and the national delivery of FACETS training courses (designed by the research team) for health care professionals (HCPs). By 2015 more than 1500 pwMS had received the FACETS program, but it is not available in all areas and a face-to-face format may not be suitable for, or appeal to, everyone. For these reasons, the MS Society funded a consultation to explore an alternative Web-based model of service delivery. Objective: The aim of this study was to gather views about a Web-based model of service delivery from HCPs who had delivered FACETS and from pwMS who had attended FACETS. Methods: Telephone consultations were undertaken with FACETS-trained HCPs who had experience of delivering FACETS (n=8). Three face-to-face consultation groups were held with pwMS who had attended the FACETS program: London (n=4), Liverpool (n=4), and Bristol (n=7). The interviews and consultation groups were digitally recorded and transcribed. A thematic analysis was undertaken to identify key themes. Toward the end of the study, a roundtable meeting was held to discuss outcomes from the consultation with representatives from the MS Society, HCPs, and pwMS. Results: Key challenges and opportunities of designing and delivering an integrated Web-based version of FACETS and maintaining user engagement were identified across 7 themes (delivery, online delivery, design, group, engagement, interactivity, and HCP relationships). Particularly of interest were themes related to replicating the group dynamics and the lack of high-quality solutions that would support the FACETS’ weekly homework tasks and symptom monitoring and management. Conclusions: A minimum viable Web-based version of FACETS was suggested as the best starting point for a phased implementation, enabling a solution that could then be added to over time. It was also proposed that a separate study should look to create a free stand-alone digital toolkit focusing on the homework elements of FACETS. This study has commenced with a first version of the toolkit in development involving pwMS throughout the design and build stages to ensure a user-centered solution.
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
Background: Laboratory automation is the actual frontier for the increase of productivity and reduction of samples turnaround time (TAT), in turn used as a key indicator of laboratory performance. How...
Background: Laboratory automation is the actual frontier for the increase of productivity and reduction of samples turnaround time (TAT), in turn used as a key indicator of laboratory performance. However, due to the statistical distribution of TAT values, classical parameters (mean, standard deviation, percentiles) fail to describe each single sample processing “story”. The driving idea of the present work is to assimilate the samples flow in an automation laboratory to the movement of molecules in solution by means of Dynamic Light Scattering Correlation Function analysis expansion. Objective: The aim of the approach is the increase of productivity and the reduction of laboratory process cycle times thus improving data quality level. The most widely known application of laboratory automation technology is robotics, based on many different automated laboratory instruments, devices (the most common being autosamplers), software algorithms and methodologies assembled together to form an unique production chain starting from the arrival of the biological sample in the lab to the output of clinical useful final results. Methods: TAT values from 10000 samples were used to build a correlation function. Through a time course, each sample perfectly correlates with its initial status (no results available) until its specific TAT value is reached and assumes a value of 1; after the TAT is reached (produced results) it no more correlates and its status value becomes 0. The generated correlation function is simply the normalized progressive timing sum of all analyzed samples status conditions at each specific time. Results: By correlation function analysis, several parameters to describe the general performance of the system as well as each individual sample status are derived and applied to monitor the efficiency of the automation chain in real time mode. Conclusions: Our original approach to laboratory automation leads to the possibility of determining measurable criteria able to describe the entire system capacity to buffer and reduce problems both on the full performance or on spot samples, consequently developing a new tool to evaluate different or improved performing systems Clinical Trial: none
Background: Health professionals have expressed unmet needs, including lacking skills, confidence, training, and resources to properly attend to the psychological needs of people with diabetes. Object...
Background: Health professionals have expressed unmet needs, including lacking skills, confidence, training, and resources to properly attend to the psychological needs of people with diabetes. Objective: Informed by needs assessments, we aimed to develop practical, evidence-based resources to support health professionals to address the emotional needs of adults with type 1 or type 2 diabetes. Methods: We developed a new handbook and toolkit informed by formative evaluation, including literature reviews, stakeholder consultation and review, and a qualitative study. In the qualitative study, health professionals participated in interviews after reading sections of the handbook and toolkit. Results: The literature review uncovered that psychological problems are common among adults with diabetes, but health professionals lack resources to provide related support. We planned and drafted resources to fill this unmet need, guided by stakeholder consultation and an Expert Reference Group. Prior to finalising the resources, we implemented feedback received from stakeholders (Expert Reference Group, health professionals, academics, and people with diabetes). The resulting products were the practical, evidence-based Diabetes and Emotional Health handbook and toolkit. Nineteen health professionals took part in the qualitative study about the handbook and toolkit. They viewed the resources favourably, felt empowered to support people with diabetes experiencing psychological problems and felt motivated to share the resources with others. Some gave examples of how they had used the handbook in clinical practice. A perceived highlight was the inclusion of a process model outlining seven steps for identifying and supporting people with emotional problems: the 7 A’s model. With funding from the National Diabetes Services Scheme (NDSS), more than 2400 copies of Diabetes and Emotional Health have been distributed. The NDSS is an initiative of the Australian Government administered with the assistance of Diabetes Australia. Conclusions: The new evidence-based resources are perceived by stakeholders as effective aids to assist health professionals in providing emotional support to adults with diabetes. The 7 A’s model may have clinical utility for routine monitoring of other psychological and health-related problems, as part of person-centred clinical care.
