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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.

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.

Background: Pain 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. Objective: The 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. Methods: Post 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. Results: Five 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. Conclusions: Overall, 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. [ABSTRACT FROM AUTHOR]

Background: Pain 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. Objective: To 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. Methods: A 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. Results: The 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. Conclusions: This 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. [ABSTRACT FROM AUTHOR]