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BackgroundVirtual reality (VR) and augmented reality (AR) interventions are emerging as promising tools in the treatment of pediatric chronic pain conditions. However, in this young field, there is little consensus to guide the process of engaging in the development and evaluation of targeted VR-based interventions. ObjectiveThe INOVATE-Pain (Interdisciplinary Network on Virtual and Augmented Technologies for Pain management) consortium aims to advance the field of VR for pediatric chronic pain rehabilitation by providing guidance for best practices in the design, evaluation, and dissemination of VR-based interventions targeting this population. MethodsAn interdisciplinary meeting of 16 academics, clinicians, industry partners, and philanthropy partners was held in January 2020. ResultsReviewing the state of the field, the consortium identified important directions for research-driven innovation in VR and AR clinical care, highlighted key opportunities and challenges facing the field, and established a consensus on best methodological practices to adopt in future efforts to advance the research and practice of VR and AR in pediatric pain. The consortium also identified important next steps to undertake to continue to advance the work in this promising new area of digital health pain interventions. ConclusionsTo realize the promise of this realm of innovation, key ingredients for success include productive partnerships among industry, academic, and clinical stakeholders; a uniform set of outcome domains and measures for standardized evaluation; and widespread access to the latest opportunities, tools, and resources. The INOVATE-Pain collaborative hopes to promote the creation, rigorous yet efficient evaluation, and dissemination of innovative VR-based interventions to reduce pain and improve quality of life for children.

BackgroundJuvenile idiopathic arthritis (JIA) is a serious and potentially debilitating pediatric illness. Improved disease self-management may help to improve health outcomes. ObjectiveThis study aimed to evaluate the effectiveness of the Teens Taking Charge Web-based self-management intervention in reducing symptoms and improving health-related quality of life (HRQL) in adolescents with JIA compared with a Web-based education control condition. MethodsAdolescents with JIA aged 12 to 18 years were recruited from 11 Canadian pediatric rheumatology centers. Caregivers were invited to participate along with their child. In addition to standard medical care, participants were randomized to receive either (1) the Teens Taking Charge self-management intervention or (2) a Web-based education control condition for a period of 12 weeks. Adolescents in the intervention group completed website modules addressing cognitive behavioral coping skills, stress management, and other self-management topics, while also receiving monthly telephone calls from a trained health coach. Adolescents in the education control group were instructed to view a series of preselected public JIA educational websites and received monthly calls from a coach who asked about their own best efforts at managing JIA. Caregivers in the intervention group completed website modules related to promoting independence and disease self-management in their child. Caregivers in the education control group were instructed to view a series of preselected public JIA educational websites. Outcome assessment occurred at baseline, 12 weeks (posttreatment), and at 6 and 12 months postrandomization. The primary outcomes were pain intensity, pain interference, and HRQL. Secondary outcomes were emotional symptoms, adherence, coping, knowledge, and self-efficacy. ResultsIn total, 333 adolescents and 306 caregivers were enrolled. Significant overall reductions in pain intensity (P=.02) and pain interference (P=.007) were observed for intervention group participants compared with those in the education control group, after adjusting for baseline levels. There was a significant overall improvement in HRQL related to problems with pain (P=.02) and problems with daily activities (P=.01). There was also a significant difference in the intervention group over time (P=.008) for HRQL related to treatment problems, with the intervention group participants demonstrating improved HRQL by 12 months compared with education control group participants. Both groups showed nonsignificant improvements compared with baseline in other primary outcomes. There were no significant differences between the groups in any secondary outcomes or caregiver-reported outcomes. ConclusionsThe results of this randomized trial suggest that the Teens Taking Charge Web-based intervention is effective at reducing both pain intensity and pain interference, as well as improving HRQL in adolescents with JIA, compared with education control. These effects are sustained for up to 12 months following program completion. The Teens Taking Charge program is now publicly available at no cost. Trial RegistrationClinicalTrials.gov NCT01572896; https://clinicaltrials.gov/ct2/show/NCT01572896

BackgroundThe most commonly used means to assess pain is by patient self-reported questionnaires. These questionnaires have traditionally been completed using paper-and-pencil, telephone, or in-person methods, which may limit the validity of the collected data. Electronic data capture methods represent a potential way to validly, reliably, and feasibly collect pain-related data from patients in both clinical and research settings. ObjectiveThe aim of this study was to conduct a systematic review and meta-analysis to compare electronic and conventional pain-related data collection methods with respect to pain score equivalence, data completeness, ease of use, efficiency, and acceptability between methods. MethodsWe searched the Medical Literature Analysis and Retrieval System Online (MEDLINE), Excerpta Medica Database (EMBASE), and Cochrane Central Register of Controlled Trials (CENTRAL) from database inception until November 2019. We included all peer-reviewed studies that compared electronic (any modality) and conventional (paper-, telephone-, or in-person–based) data capture methods for patient-reported pain data on one of the following outcomes: pain score equivalence, data completeness, ease of use, efficiency, and acceptability. We used random effects models to combine score equivalence data across studies that reported correlations or measures of agreement between electronic and conventional pain assessment methods. ResultsA total of 53 unique studies were included in this systematic review, of which 21 were included in the meta-analysis. Overall, the pain scores reported electronically were congruent with those reported using conventional modalities, with the majority of studies (36/44, 82%) that reported on pain scores demonstrating this relationship. The weighted summary correlation coefficient of pain score equivalence from our meta-analysis was 0.92 (95% CI 0.88-0.95). Studies on data completeness, patient- or provider-reported ease of use, and efficiency generally indicated that electronic data capture methods were equivalent or superior to conventional methods. Most (19/23, 83%) studies that directly surveyed patients reported that the electronic format was the preferred data collection method. ConclusionsElectronic pain-related data capture methods are comparable with conventional methods in terms of score equivalence, data completeness, ease, efficiency, and acceptability and, if the appropriate psychometric evaluations are in place, are a feasible means to collect pain data in clinical and research settings.

BackgroundDigital technologies connect young people with health services and resources that support their self-care. The lack of accessible, reliable digital resources tailored to young people with persistent musculoskeletal pain is a significant gap in the health services in Australia. Recognizing the intense resourcing required to develop and implement effective electronic health (eHealth) interventions, the adaptation of extant, proven digital technologies may improve access to pain care with cost and time efficiencies. ObjectiveThis study aimed to test the acceptability and need for adaptation of extant digital technologies, the painHEALTH website and the iCanCope with Pain app, for use by young Australians with musculoskeletal pain. MethodsA 3-phased, mixed methods evaluation was undertaken from May 2019 to August 2019 in Australia. Young people aged 15 to 25 years with musculoskeletal pain for >3 months were recruited. Phases were sequential: (1) phase 1, participant testing (3 groups, each of n=5) of co-designed website prototypes compared with a control website (painHEALTH), with user tasks mapped to eHealth quality and engagement criteria; (2) phase 2, participants’ week-long use of the iCanCope with Pain app with engagement data captured using a real-time analytic platform (daily check-ins for pain, interference, sleep, mood, physical activity, and energy levels; goal setting; and accessing resources); and (3) phase 3, semistructured interviews were conducted to gain insights into participants’ experiences of using these digital technologies. ResultsFifteen young people (12/15, 80% female; mean age 20.5 [SD 3.3] years; range 15-25 years) participated in all 3 phases. The phase 1 aggregated group data informed the recommendations used to guide 3 rapid cycles of prototype iteration. Adaptations included optimizing navigation, improving usability (functionality), and enhancing content to promote user engagement and acceptability. In phase 2, all participants checked in, with the highest frequency of full check-ins attributed to pain intensity (183/183, 100.0%), pain interference (175/183, 95.6%), and mood (152/183, 83.1%), respectively. Individual variability was evident for monitoring progress with the highest frequency of history views for pain intensity (51/183, 32.3%), followed by pain interference (24/183, 15.2%). For the goals set feature, 87% (13/15) of participants set a total of 42 goals covering 5 areas, most frequently for activity (35/42, 83%). For phase 3, metasynthesis of qualitative data highlighted that these digital tools were perceived as youth-focused and acceptable. A total of 4 metathemes emerged: (1) importance of user-centered design to leverage user engagement; (2) website design (features) promoting user acceptability and engagement; (3) app functionality supporting self-management; and (4) the role of wider promotion, health professional digital prescriptions, and strategies to ensure longer-term engagement. ConclusionsLeveraging extant digital tools, with appropriate user-informed adaptations, can help to build capacity tailored to support young people’s self-management of musculoskeletal pain.

BackgroundThere is mixed evidence to support current ambitions for mobile health (mHealth) apps to improve chronic health and well-being. One proposed explanation for this variable effect is that users do not engage with apps as intended. The application of analytics, defined as the use of data to generate new insights, is an emerging approach to study and interpret engagement with mHealth interventions. ObjectiveThis study aimed to consolidate how analytic indicators of engagement have previously been applied across clinical and technological contexts, to inform how they might be optimally applied in future evaluations. MethodsWe conducted a scoping review to catalog the range of analytic indicators being used in evaluations of consumer mHealth apps for chronic conditions. We categorized studies according to app structure and application of engagement data and calculated descriptive data for each category. Chi-square and Fisher exact tests of independence were applied to calculate differences between coded variables. ResultsA total of 41 studies met our inclusion criteria. The average mHealth evaluation included for review was a two-group pretest-posttest randomized controlled trial of a hybrid-structured app for mental health self-management, had 103 participants, lasted 5 months, did not provide access to health care provider services, measured 3 analytic indicators of engagement, segmented users based on engagement data, applied engagement data for descriptive analyses, and did not report on attrition. Across the reviewed studies, engagement was measured using the following 7 analytic indicators: the number of measures recorded (76%, 31/41), the frequency of interactions logged (73%, 30/41), the number of features accessed (49%, 20/41), the number of log-ins or sessions logged (46%, 19/41), the number of modules or lessons started or completed (29%, 12/41), time spent engaging with the app (27%, 11/41), and the number or content of pages accessed (17%, 7/41). Engagement with unstructured apps was mostly measured by the number of features accessed (8/10, P=.04), and engagement with hybrid apps was mostly measured by the number of measures recorded (21/24, P=.03). A total of 24 studies presented, described, or summarized the data generated from applying analytic indicators to measure engagement. The remaining 17 studies used or planned to use these data to infer a relationship between engagement patterns and intended outcomes. ConclusionsAlthough researchers measured on average 3 indicators in a single study, the majority reported findings descriptively and did not further investigate how engagement with an app contributed to its impact on health and well-being. Researchers are gaining nuanced insights into engagement but are not yet characterizing effective engagement for improved outcomes. Raising the standard of mHealth app efficacy through measuring analytic indicators of engagement may enable greater confidence in the causal impact of apps on improved chronic health and well-being.

BackgroundMobile health (mHealth) apps for pediatric chronic conditions are growing in availability and challenge investigators to conduct rigorous evaluations that keep pace with mHealth innovation. Traditional research methods are poorly suited to operationalize the agile, iterative trials required to evidence and optimize these digitally mediated interventions. ObjectiveWe sought to contribute a resource to support the quantification, analysis, and visualization of analytic indicators of effective engagement with mHealth apps for chronic conditions. MethodsWe applied user-centered design methods to design and develop an Analytics Platform to Evaluate Effective Engagement (APEEE) with consumer mHealth apps for chronic conditions and implemented the platform to analyze both retrospective and prospective data generated from a smartphone-based pain self-management app called iCanCope for young people with chronic pain. ResultsThrough APEEE, we were able to automate the process of defining, operationalizing, and evaluating effective engagement with iCanCope. Configuring the platform to integrate with the app was feasible and provided investigators with a resource to consolidate, analyze, and visualize engagement data generated by participants in real time. Preliminary efforts to evaluate APEEE showed that investigators perceived the platform to be an acceptable evaluative resource and were satisfied with its design, functionality, and performance. Investigators saw potential in APEEE to accelerate and augment evidence generation and expressed enthusiasm for adopting the platform to support their evaluative practice once fully implemented. ConclusionsDynamic, real-time analytic platforms may provide investigators with a powerful means to characterize the breadth and depth of mHealth app engagement required to achieve intended health outcomes. Successful implementation of APEEE into evaluative practice may contribute to the realization of effective and evidence-based mHealth care.

BackgroundPain in adolescents with cancer is common and negatively impacts health-related quality of life. The Pain Squad+ smartphone app, capable of providing adolescents with real-time pain management support, was developed to enhance pain management using a phased approach (ie, systematic review, consensus conference and vetting, iterative usability testing cycles). A 28-day Pain Squad+ pilot was conducted with 40 adolescents with cancer to evaluate the feasibility of implementing the app in a future clinical trial and to obtain estimates of treatment effect. ObjectiveThe objective of our nested qualitative study was to elucidate the perceptions of adolescents with cancer to determine the acceptability and perceived helpfulness of Pain Squad+, suggestions for app improvement, and satisfaction with the pilot study protocol. MethodsPost pilot study participation, telephone-based, semistructured, and audio-recorded exit interviews were conducted with 20 adolescents with cancer (12-18 years). All interviews were transcribed and independently coded by 2 study team members. Content analysis was conducted to identify data categories and overarching themes. ResultsFive major themes comprising multiple categories and codes emerged. These themes focused on the acceptability of the intervention, acceptability of the study, the perceived active ingredients of the intervention, the suitability of the intervention to adolescents’ lives, and recommendations for intervention improvement. ConclusionsOverall, Pain Squad+ and the pilot study protocol were acceptable to adolescents with cancer. Suggestions for intervention and study improvements will be incorporated into the design of a future randomized clinical trial (RCT) aimed at assessing the effectiveness of Pain Squad+ on adolescents with cancer health outcomes.

BackgroundHeadaches are prevalent among teens and young adults. Self-monitoring is essential for managing headaches and can be accomplished with the help of electronic headache diaries. An increasing number of electronic headache diaries exist, yet the absence of quality standards compromises their use for research and clinical purposes. ObjectiveOur goal was to develop and test the usability, feasibility, and psychometric properties of an electronic diary iPhone application for self-monitoring by adolescents and young adults with headaches. MethodsWe used an iterative participatory design to develop and test our electronic headache diary. Participants aged 14-28 years old with recurrent headaches were recruited internationally. Screening and consent were conducted online. Following completion of an online pre-questionnaire, participants downloaded the diary to use in their natural environment for 14 days. An online post-questionnaire was completed following testing. The diary’s usability and feasibility were tested first and determined to be complete when improvements to the diary did not result in a statistically significant impact on indicators of feasibility and adherence. Interviews were conducted with participants of usability and feasibility testing. The psychometric properties of the diary were then tested, and a case study analysis of one participant was completed. ResultsThree cycles to test the usability and feasibility were conducted. Each cycle included 11-19 unique participants ranging in age from 16 to 28 years. Following the testing period for each cycle, 15% to 25% of participants took part in the post-cycle interview. Participants perceived the final version of the diary as useful, easy to learn, and efficient to use. Psychometric properties were then tested with a sample of 65 participants (6 aged 14-17 years old; 59 aged 18-28 years old). All items in the diary had substantial between- and within-subjects variability (percent of variance for the two participant groups ranged from 20.64 to 75.60 and 23.74 to 79.21, respectively). Moreover, the Migraine Disability Assessment (MIDAS) included in the diary had adequate between-subjects reliability (R1F=0.66, RKF=0.98), but low within-subjects reliability (RC=0.51). Critical elements of the diary demonstrated adequate convergent and concurrent validity, particularly in the older age group (18-28 years). The validity of some critical elements of the diary could not be explored in the younger age group due to the small subgroup size. The case study provides an example of the potential utility of the diary. ConclusionsOur electronic headache diary was shown to be a usable and feasible self-monitoring tool when used by adolescents and young adults with headaches for 14 days. This study provides preliminary support of its psychometric properties. Our diary has the potential for helping users to better understand their headaches and, consequently, to change behaviors to improve self-management of their headaches. Its effectiveness as a component of an intervention will be the focus of future research.

BackgroundHeadache diaries are often used by headache sufferers to self-monitor headaches. With advances in mobile technology, mobile electronic diary apps are becoming increasingly common. ObjectiveThis review aims to identify and evaluate all commercially available mobile headache diary apps for the two most popular mobile phone platforms, iOS and Android. MethodsThe authors developed a priori a set of 7 criteria that define an ideal headache diary app intended to help headache sufferers better understand and manage their headaches, while providing relevant data to health professionals. The app criteria were intended as minimum requirements for an acceptable headache diary app that could be prescribed by health care professionals. Each app was evaluated and scored against each criterion. ResultsOf the 38 apps identified, none of the apps met all 7 app criteria. The 3 highest scoring apps, meeting 5 of the app criteria, were iHeadache (developed by Better QOL), ecoHeadache (developed by ecoTouchMedia), and Headache Diary Pro (developed by Froggyware). Only 18% of the apps were created with scientific or clinical headache expertise and none of the apps reported on psychometric properties. ConclusionsDespite the growing market and demand, there is a concerning lack of scientific expertise and evidence base associated with headache diary apps.

BackgroundChronic pain is a prevalent and debilitating problem. Accurate and timely pain assessment is critical to pain management. In particular, pain needs to be consistently tracked over time in order to gauge the effectiveness of different treatments. In current clinical practice, paper-based questionnaires are the norm for pain assessment. However, these methods are not conducive to capturing or tracking the complex sensations of chronic pain. Pain-QuILT (previously called the Iconic Pain Assessment Tool) is a Web-based tool for the visual self-report and tracking of pain (quality, intensity, location, tracker) in the form of time-stamped records. It has been iteratively developed and evaluated in adolescents and adults with chronic pain, including usability testing and content validation. Clinical feasibility is an important stepping-stone toward widespread implementation of a new tool. Our group has demonstrated Pain-QuILT clinical feasibility in the context of a pediatric chronic pain clinic. We sought to extend these findings by evaluating Pain-QuILT clinical feasibility from the perspective of adults with chronic pain, in comparison with standard paper-based methods (McGill Pain Questionnaire [MPQ] and Brief Pain Inventory [BPI]). ObjectiveThe goal of our study was to assess Pain-QuILT for (1) ease of use, (2) time for completion, (3) patient preferences, and (4) to explore the patterns of self-reported pain across the Pain-QuILT, MPQ, and BPI. MethodsParticipants were recruited during a scheduled follow-up visit at a hospital-affiliated pain management and physical rehabilitation clinic in southwestern Ontario. Participants self-reported their current pain using the Pain-QuILT, MPQ, and BPI (randomized order). A semistructured interview format was used to capture participant preferences for pain self-report. ResultsThe sample consisted of 50 adults (54% female, 27/50) with a mean age of 50 years. Pain-QuILT was rated as significantly easier to use than both the MPQ and BPI (P

BackgroundPain that occurs both within and outside of the hospital setting is a common and distressing problem for adolescents with cancer. The use of smartphone technology may facilitate rapid, in-the-moment pain support for this population. To ensure the best possible pain management advice is given, evidence-based and expert-vetted care algorithms and system design features, which are designed using user-centered methods, are required. ObjectiveTo develop the decision algorithm and system requirements that will inform the pain management advice provided by a real-time smartphone-based pain management app for adolescents with cancer. MethodsA systematic approach to algorithm development and system design was utilized. Initially, a comprehensive literature review was undertaken to understand the current body of knowledge pertaining to pediatric cancer pain management. A user-centered approach to development was used as the results of the review were disseminated to 15 international experts (clinicians, scientists, and a consumer) in pediatric pain, pediatric oncology and mHealth design, who participated in a 2-day consensus conference. This conference used nominal group technique to develop consensus on important pain inputs, pain management advice, and system design requirements. Using data generated at the conference, a prototype algorithm was developed. Iterative qualitative testing was conducted with adolescents with cancer, as well as pediatric oncology and pain health care providers to vet and refine the developed algorithm and system requirements for the real-time smartphone app. ResultsThe systematic literature review established the current state of research related to nonpharmacological pediatric cancer pain management. The 2-day consensus conference established which clinically important pain inputs by adolescents would require action (pain management advice) from the app, the appropriate advice the app should provide to adolescents in pain, and the functional requirements of the app. These results were used to build a detailed prototype algorithm capable of providing adolescents with pain management support based on their individual pain. Analysis of qualitative interviews with 9 multidisciplinary health care professionals and 10 adolescents resulted in 4 themes that helped to adapt the algorithm and requirements to the needs of adolescents. Specifically, themes were overall endorsement of the system, the need for a clinical expert, the need to individualize the system, and changes to the algorithm to improve potential clinical effectiveness. ConclusionsThis study used a phased and user-centered approach to develop a pain management algorithm for adolescents with cancer and the system requirements of an associated app. The smartphone software is currently being created and subsequent work will focus on the usability, feasibility, and effectiveness testing of the app for adolescents with cancer pain.

BackgroundPain is one of the most common and distressing symptoms reported by adolescents with cancer. Despite advancements in pain assessment and management research, pain due to cancer and/or its treatments continues to be poorly managed. Our research group has developed a native iPhone application (app) called Pain Squad to tackle the problem of poorly managed pain in the adolescent with cancer group. The app functions as an electronic pain diary and is unique in its ability to collect data on pain intensity, duration, location, and the impact pain has on an adolescent’s life (ie, relationships, school work, sleep, mood). It also evaluates medications and other physical and psychological pain management strategies used. Users are prompted twice daily at configurable times to complete 20 questions characterizing their pain and the app transmits results to a database for aggregate reporting through a Web interface. Each diary entry represents a pain case filed by an adolescent with cancer and a reward system (ie, moving up through law-enforcement team ranks, built-in videotaped acknowledgements from fictitious officers) encourages consistent use of the diary. ObjectiveOur objective was to design, develop, and test the usability, feasibility, compliance, and satisfaction of a game-based smartphone pain assessment tool for adolescents with cancer. MethodsWe used both low- and high-fidelity qualitative usability testing with qualitative semi-structured, audio-taped interviews and iterative cycles to design and refine the iPhone based Pain Squad app. Qualitative thematic analysis of interviews using constant comparative methodology captured emergent themes related to app usability. Content validity was assessed using question importance-rating surveys completed by participants. Compliance and satisfaction data were collected following a 2-week feasibility trial where users were alarmed to record their pain twice daily on the app. ResultsThematic analysis of usability interviews showed the app to be appealing overall to adolescents. Analyses of both low- and high-fidelity testing resulted in minor revisions to the app to refine the theme and improve its usability. Adolescents resoundingly endorsed the game-based nature of the app and its virtual reward system. The importance of app pain diary questions was established by content validity analysis. Compliance with the app, assessed during feasibility testing, was high (mean 81%, SD 22%) and adolescents from this phase of the study found the app likeable, easy to use, and not bothersome to complete. ConclusionsA multifaceted usability approach demonstrated how the Pain Squad app could be made more appealing to children and adolescents with cancer. The game-based nature and built-in reward system of the app was appealing to adolescents and may have resulted in the high compliance rates and satisfaction ratings observed during clinical feasibility testing.