Electronic Pain Diary Research Articles

Interventions for Assessment and Enhancement of Pain Management Competencies among Healthcare Professionals

To pain management competencies among healthcare professionals is crucial for improving patient care and outcomes. Healthcare professionals must possess the necessary knowledge, skills, and techniques to effectively manage and treat pain in their patients. This includes understanding different types of pain, assessing pain levels, and utilizing appropriate interventions. By accurately assessing pain levels and implementing a multimodal approach to pain management, healthcare professionals can optimize patient outcomes and minimize risks. Effective communication skills and staying updated on the latest evidence-based practices are also essential. Continuous education and professional development are vital for healthcare professionals to enhance their pain management competencies and deliver the best possible care.Include training healthcare professionals in pain assessment techniques, educating them on the multidimensional nature of pain, providing resources and tools for accurate and comprehensive pain evaluation, encouraging interdisciplinary collaboration to enhance pain management strategies, fostering a patient-centered approach that values the individual's self-reporting of pain, promoting ongoing education and professional development to ensure up-to-date knowledge and skills, conducting regular assessments and evaluations to monitor the effectiveness of pain assessment training programs, and supporting a culture of continuous improvement and innovation in pain assessment practices. Additionally, technology-based solutions such as electronic pain diaries and telemedicine can be utilized to enhance pain assessment and monitoring capabilities.Include successful implementation and execution of transformative educational programs, catering to diverse learner needs. These initiatives foster holistic learning, instilling a love for knowledge in students. Outcomes show remarkable progress, enhanced critical thinking, creativity, and problem-solving abilities. Innovative teaching and cutting-edge technologies empower countless individuals, unlocking their potential and achieving academic excellence. Collaborative approach establishes a foundation for lifelong learning and personal development. Equipped with acquired knowledge and skills, individuals make a lasting impact in their fields, shaping a brighter future for themselves and society.Pain management is an incredibly crucial aspect of healthcare, and it is absolutely essential for healthcare professionals to possess the necessary competencies to accurately assess and greatly enhance their ability to provide highly effective pain management interventions. Ensuring that patients receive optimal pain relief and care should be a top priority for all healthcare providers, as it positively contributes to their overall wellbeing and enhances the quality of their medical treatment. Therefore, healthcare professionals must continuously invest time and effort in expanding their knowledge and skills related to pain management to ensure they can deliver the highest level of care to their patients. By doing so, we can strive towards a healthcare system that prioritizes pain management and empowers healthcare professionals to make a significant difference in their patients' lives.

Effects of Music Therapy on Quality of Life in Adults with Sickle Cell Disease (MUSIQOLS): A Mixed Methods Feasibility Study.

PurposeTo investigate the feasibility, acceptability, and preliminary efficacy of a 6-session music therapy protocol on self-efficacy, quality of life, and coping skills in adults with sickle cell disease (SCD).Patients and MethodsUsing a mixed-methods intervention design, adults with SCD (ages 21–57; mean age 32.33) were randomized (1:1) to either 1) a 6-session music therapy (MT) intervention (n = 12) or 2) waitlist control (WLC) (n = 12) using stratified randomization where factors were age in years (≤30 vs >30), and sex (male, female). All participants completed two weeks of daily electronic pain diary entries and self-efficacy, quality of life, and coping skills measures before and after their assigned study condition to explore preliminary efficacy. MT participants were taught music exercises accessed via smartphone and subsequently interviewed to determine feasibility and acceptability.ResultsThe enrollment rate was 89%. All study measures were completed, with high rates of electronic pain diary completion at baseline (70%) and 2-week follow-up (66%). Interviews revealed two overall themes related to MT participants’ experience: 1) participants learned new self-management skills and 2) MT improved participants’ ability to cope with pain. MT participants demonstrated 100% attendance. In preliminary analyses, MT participants demonstrated significant improvements (means ± SD) in self-efficacy (5.42 ± 5.43, p = 0.008, d = 1.20), PROMIS sleep disturbance (−1.49 ± 6.68, p = 0.023, d = −0.99), PROMIS pain interference (−2.10 ± 4.68, p = 0.016, d = −1.06), and ASCQ-Me social functioning impact scores (2.97 ± 6.91, p = 0.018, d = 1.05) compared to WLC participants.ConclusionPreliminary findings support the feasibility and acceptability of music therapy for home use in adults with SCD. While music therapy may assist adults with SCD in improving self-efficacy and quality of life, subsequent, fully-powered clinical research is needed to determine its efficacy.

Exploring Parental Responses to Pre-schoolers' "Everyday" Pain Experiences Through Electronic Diary and Ecological Momentary Assessment Methodologies.

Objective: Parental influence during children’s “everyday” pain events is under-explored, compared to clinical or experimental pains. We trialed two digital reporting methods for parents to record the real-world context surrounding their child’s everyday pain events within the family home.Methods: Parents (N = 21) completed a structured e-diary for 14 days, reporting on one pain event experienced by their child (aged 2.5–6 years) each day, and describing child pain responses, parental supervision, parental estimates of pain severity and intensity, and parental catastrophizing, distress, and behavioral responses. During the same 2-week period, a subsample of parent-child pairs (N = 9) completed digital ecological momentary assessments (EMA), immediately after any chosen pain event. Children reported their current pain while parents estimated the child’s pain and indicated their own distress.Results: “Everyday” pain events frequently featured minor injuries to the child’s head, hands or knees, and child responses included crying and non-verbal comments (e.g., “Ouch!”). Pain events occurred less frequently when parents had been supervising their child, and supervising parents reported lower levels of worry and anxiety than non-supervising parents. Child sex was significantly associated with parental estimates of pain intensity, with parents of girls giving higher estimates than parents of boys. Child age was significantly associated with both the number of pain events and with parental estimates of pain intensity and child distress: the youngest children (2–3 years) experienced the fewest pain events but received higher pain and distress estimates from parents than older children. Hierarchal Linear Modeling revealed that parental estimates of pain severity were significant positive predictors of parental distress and catastrophizing in response to a specific pain event. Furthermore, higher levels of parental catastrophic thinking in response to a specific pain event resulted in increased distress, solicitousness, and coping-promoting behaviors in parents. The EMA data revealed that children reported significantly higher pain intensity than their parents.Conclusion: The electronic pain diary provided a key insight into the nature of “everyday” pain experiences around the family home. Digital daily reporting of how the family copes with “everyday” events represents a viable means to explore a child’s everyday pains without disrupting their home environment.

An Ecological Monitoring and Management App (EMMA) for Older Adults With Chronic Pain: Protocol for a Design and Feasibility Study.

BackgroundChronic pain is a complex problem for many older adults that affects both physical functioning and psychological well-being. Mobile health (mHealth) technologies have shown promise in supporting older persons in managing chronic conditions. Cognitive behavior therapy is recommended for older people with chronic pain. However, web-based treatment programs for chronic pain are not aimed at the needs of older people and offer standard therapies without providing tailored treatment for this population.ObjectiveTo address this problem, we aim to develop a psychological web-based intervention for ecological monitoring of daily life experiences with chronic pain called EMMA to support self-management of chronic pain in older adults.MethodsThe key clinical and engagement features of the intervention were established through the integration of evidence-based material from cognitive behavioral therapy for the treatment of chronic pain in older adults. The development process uses a co-design approach and actively involves end-users in the design process by incorporating feedback from focus groups with older adults in order to inform a user-centered intervention design. For the co-design process, we will include 10 older adults with chronic pain, who will discuss the requirements for the app in workshops in order to ensure suitability of the app for older adults with chronic pain. In order to test the feasibility and acceptability of the intervention, we will include a sample of 30 older adults with chronic pain who will test all features of the intervention for a period of 8 consecutive weeks. After the trial period, validated instruments will be used to assess usability and acceptability, as well as influence on pain levels and associated physical and psychological symptoms. Participants will be invited to take part in a semistructured telephone interviews after the trial period to explore their experiences using the app.ResultsDigitalization of the pain diary and psychotherapeutic content has started. Recruitment of participants for the co-design workshops will start as soon as we have a functioning prototype of the electronic pain diary and EMMA intervention, which is expected to be in September 2021. The feasibility study will start as soon as the co-design process is finished and required changes have been implemented into the pain diary and the EMMA intervention. We expect to start the feasibility study early in 2022.ConclusionsRequired changes to assure usability and acceptability will be directly implemented in the app. EMMA brings together a strong body of evidence using cognitive behavioral and self-management theory with contemporary mHealth principles, allowing for a cost-effective intervention that can be used to target chronic pain anywhere and anytime by older adults. Given the ubiquity of mHealth interventions for chronic conditions, the results of this study may serve to inform the development of tailored self-management interventions.International Registered Report Identifier (IRRID)PRR1-10.2196/26930

Parental Engagement of a Prototype Electronic Diary in an Ambulatory Setting Following Adenotonsillectomy in Children: A Prospective Cohort Study

Adenotonsillectomy is performed in children on an outpatient basis, and pain is managed by parents. A pain diary would facilitate pain management in the ambulatory setting. Our objective was to evaluate the parental response rate and the compliance of a prototype electronic pain diary (e-diary) with cloud storage in children aged 2–12 years recovering from adenotonsillectomy and to compare the e-diary with a paper diary (p-diary). Parents recorded pain scores twice daily in a pain diary for 2 weeks post-operation. Parents were given the choice of an e-diary or p-diary with picture message. A total of 208 patients were recruited, of which 35 parents (16.8%) chose the e-diary. Most parents (98%) chose to be contacted by text message. Eighty-one families (47%) returned p-diaries to us by mail. However, the response rate increased to 77% and was similar to that of the e-diary (80%) when we included data texted to the research phone from 53 families. The proportion of diaries with Complete (e-diary:0.37 vs. p-diary:0.4) and Incomplete (e-diary:0.43 vs. p-diary:0.38) data entries were similar. E-diaries provide a means to follow patients in real time after discharge. Our findings suggest that a smartphone-based medical health application coupled with a cloud would meet the needs of families and health care providers alike.

A novel cortical biomarker signature for predicting pain sensitivity: protocol for the PREDICT longitudinal analytical validation study.

Temporomandibular disorder is a common musculoskeletal pain condition with development of chronic symptoms in 49% of patients. Although a number of biological factors have shown an association with chronic temporomandibular disorder in cross-sectional and case control studies, there are currently no biomarkers that can predict the development of chronic symptoms. The PREDICT study aims to undertake analytical validation of a novel peak alpha frequency (PAF) and corticomotor excitability (CME) biomarker signature using a human model of the transition to sustained myofascial temporomandibular pain (masseter intramuscular injection of nerve growth factor [NGF]). This article describes, a priori, the methods and analysis plan. This study uses a multisite longitudinal, experimental study to follow individuals for a period of 30 days as they progressively develop and experience complete resolution of NGF-induced muscle pain. One hundred fifty healthy participants will be recruited. Participants will complete twice daily electronic pain diaries from day 0 to day 30 and undergo assessment of pressure pain thresholds, and recording of PAF and CME on days 0, 2, and 5. Intramuscular injection of NGF will be given into the right masseter muscle on days 0 and 2. The primary outcome is pain sensitivity. PREDICT is the first study to undertake analytical validation of a PAF and CME biomarker signature. The study will determine the sensitivity, specificity, and accuracy of the biomarker signature to predict an individual's sensitivity to pain. ClinicalTrials.gov: NCT04241562 (prospective).

314 Assessing pacing in patients with chronic widespread pain using accelerometry and an electronic pain diary

314 Assessing pacing in patients with chronic widespread pain using accelerometry and an electronic pain diary

Novel Metrics in the Longitudinal Evaluation of Pain Data in Sickle Cell Disease.

Available modalities for the longitudinal capture and analysis of pain intensity in patients with sickle cell disease (SCD) limit our ability to study intraindividual and interindividual variation in pain and the factors influencing the transition from acute to chronic pain in patients with SCD. The objectives of this study were to determine the feasibility of electronic capture of longitudinal outpatient pain intensity data and to test the applicability of novel metrics in the study of intraindividual and interindividual variation in pain in patients with SCD. Twenty SCD patients aged 13 to 21 submitted 2045 diary days of pain intensity data over 229 days using a web-based electronic pain diary or through text message. Participants reported pain (11-point Numerical Rating Score >0) on 1559 diary days (76.2%) suggesting a significant outpatient pain burden. In addition to mean maximum daily pain (MMDP), using maximum daily pain (MDP) scores, we calculated the ninetieth percentile (p90) of MDP, proportion of pain-free days (PPFD), Standard Deviation (SD) of MDP and coefficient of variation (CV) of MDP. Although p50 of MDP and p90 of MDP correlated positively with MMDP, PPFD correlated negatively with MMDP and both MMDP and PPFD correlated poorly with the SD of MDP. Examination of graphic representation of pain trends demonstrated how patients with similar MMDP had varying p90, PPFD, SD/coefficient of variation, and ultimately burden of pain over time. Missing data rates were lowest in the first 30 days of reporting and increased over time. Study participants reported a positive experience with momentary pain reporting and improved communication with health care providers regarding pain. The longitudinal collection of pain data with the inclusion of hospital data during periods of hospitalization is feasible and acceptable in patients with SCD over periods of 30 to 60 days. Long-term collection of pain diary data, while informative, is associated with higher rates of missing data. Novel metrics of pain have the potential to better describe intraindividual and interindividual variation in pain, inform studies of the transition from acute to chronic pain as well as contribute patient-reported end points of pain for interventional clinical trials of pain in SCD.

Integration of Mobile Health Technology in the Treatment of Chronic Pain

This article provides a critical overview and best-evidence synthesis of the use of mobile health (mHealth) technology among persons with chronic pain and their health care providers and examines the future benefits and barriers of implementing mHealth technology in clinical care. We critically review articles about electronic pain diaries, pain assessment programs, text messaging, and smartphone pain apps for management of persons with pain. Also presented are findings on the utility of activity trackers and use of telehealth to deliver cognitive behavioral therapy. Finally, barriers, study gaps, and future challenges of incorporating mobile technology for chronic pain are discussed. Although the future of mHealth technology and telemedicine in clinical practice is promising, this critical review highlights the need for rigorous studies to establish an association of the use of mHealth technology with improved quality of life, functional autonomy, and decreased hospital use.

Overnight Respiratory Support for Prevention of Morbidity in Sickle Cell Disease (POMS 2a) - Parent and Child Preferences

PURPOSEObstructive sleep apnea and nocturnal hypoxemia are common in children with sickle cell disease (SCD) and some degree of improvement has been reported following adenotonsillectomy(Finch et al., 2013). NOT and continuous positive airways pressure (CPAP) have shown some benefits in children and adolescent patients(Hargrave, 2003). While NOT and CPAP are offered to children with or without co-morbidities, there are concerns about acceptability and safety(Makani et al., 2009). The data on patient preference is limited in childhood and more so for those with SCD. To achieve optimal adherence to therapy in SCD, Auto-Adjusting Positive Airways Pressure (APAP), where airway pressure is delivered only when obstruction occurs, may be a more acceptable option than CPAP(Marshall et al., 2009). Therefore prior to designing Phase II and III trials that are adequately powered, this study sought to: i) identify parent/caregiver and child treatment preference; ii) assess whether parent/caregiver or child should manage the electronic pain diary; iii) assess any treatment effect on Health Related Quality of Life (HRQOL) in children; and iv) explore the relationship of treatment adherence to: a) experience of pain, and b) overall clinical benefit from the intervention. HYPOTHESES1. Treatment adherence of children or adults with would be directly related a) HRQOL quantitative measures, and b) improvement in symptoms reported through semi-structured interviews of patients;2. Children >8 years would be able to record their experience of pain in an appropriate electronic pain diary;3. Treatment adherence would be predictive of effect on pain frequency. METHODWe utilised mixed-methods to explore the primary endpoint of patient experience of treatment intervention, and the secondary endpoint of pain, in a sample of 11 children (aged >8 years) with homozygous SCD. The statistician was blinded to order of intervention. Two interventions NOT and APAP were conducted for one week each in randomized order, with a washout week between interventions. Qualitative data was obtained through in-depth interviews with children and their parents/caregivers conducted by a research psychologist using content method of analysis; quantitative measures were explored employing the Pediatric Quality of Life InventoryTM (PedsQL)(Panepinto et al., 2013) including the sickle module. All analyses were preliminary, exploratory and mainly descriptive. The secondary endpoint of pain was captured utilizing a pain rating scale and symptom assessment on smart technology via an iPad(Jacob et al., 2012). Other secondary outcomes included adverse events, daytime oxygen saturation, and lung function.. All variables were reported for three time points: baseline, post-intervention 1 and post-intervention 2. RESULTSAnalysis of interviews between children and parents/caregivers revealed similarities in expectations prior to treatment, and variations in post-study perception of treatment. Parents/caregivers and children emphasised impact on other family members, practical concerns and challenges as objective criteria for treatment preference, while children additionally emphasized night time positive/negative sensory experiences: e.g. airflow, dreams, breathing, sound, as influences for treatment preference. Belief that treatment is beneficial only for children with breathing difficulties emerged as an influence on both expectation and perception of positive benefits. In 7 children for whom APAP adherence data were available, pain was noted after 3 nights with a median adherence of 5.23 (range 4.0-6.1) hours and was not noted after 38 nights with a median adherence of 8.03 (range 3.21-10.19) hours (p=0.2). For 4 children with pain recorded on 2, 2, 2 and 4 days in the pre-treatment week, 3 recorded no pain on APAP and the child with 4 days pre-treatment recorded 2 days on APAP. CONCLUSIONSThese data reveal some variation in approaches toward treatment preferences between parents/caregivers and children, and supports an inclusive approach to facilitate appropriate treatment choice. Adherence data are not available for oxygen but there is some evidence for reduction in pain in relation to APAP adherence. This trial will contribute to understanding in participant feasibility and acceptability for therapeutic intervention. Research results will be used to inform design of the Phase II and III trials. DisclosuresNo relevant conflicts of interest to declare.

Simvastatin Reduces Frequency of Vaso-Occlusive Pain in Sickle Cell Disease: A Pilot Efficacy Trial

BackgroundSicke cell disease is characterized by progressive vascular injury as a result of vaso-occlusion, ischemia-reperfusion and a sustained state of chronic Inflammation. Despite the broad impact of inflammation on acute and chronic clinical manifestations of SCD, no directed anti-inflammatory therapies for the treatment or prevention of vaso-occlusive events currently exist. Statins (3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors) have been shown to improve vascular function, independent of their lipid-lowering properties, by suppressing the inflammatory response to endothelial injury and restoring nitric oxide (NO) bioavailability. We previously documented a reduction in plasma biomarkers of inflammation and endothelial adhesion in SCD patients treated with short-term simvastatin. The objective of this study was to evaluate the potential clinical efficacy of simvastatin in reducing the frequency of vaso-occlusive pain in SCD.MethodsThis was a single-center, open-label, uncontrolled pilot trial. Subjects (Hb SS or S/beta0 thalassemia, >10 years of age) received once daily oral simvastatin (40mg) for 3 months. The primary outcome measure was frequency and intensity of vaso-occlusive pain, as recorded by daily electronic pain diaries, before and after simvastatin treatment. Clinical laboratory studies and plasma biomarkers (NO metabolites, hs-CRP, sVCAM-1, sICAM-1, sE-selectin, sVEGF) were evaluated at baseline, at 0.5, 1, 2 and 3 months during treatment and one month after discontinuation of simvastatin.ResultsA total of 24 subjects were enrolled (15F/9M; mean age= 19 yrs, range 10-34 yrs). Of these, 5 subjects dropped out (2 lost to follow up, 3 non-adherent to protocol) and 19 subjects completed the study. Simvastatin was well tolerated without toxicity. There were two SAE, unrelated to study drug and one AE, possibly related to simvastatin. Total cholesterol levels decreased by 10% (p=0.005) from baseline during the treatment period. There were no changes from baseline in other clinical safety laboratory parameters, including markers of hemolysis (hemoglobin (Hb), reticulocyte count, lactate dehydrogenase (LDH), total bilirubin). Average adherence with daily pain diaries was 73% (range, 47%- 97%). Pain rate (proportion of pain days) decreased by 32% (p=0.02) from baseline, while pain intensity did not change in response to treatment. The effect of simvastatin on soluble markers of inflammation was demonstrated by a 59% reduction in hs-CRP (p=0.003), 18% reduction in sE-selectin (p=0.01), 5% in sICAM-1 (p=0.03). Treatment with simvastatin had no effect on plasma levels of nitric oxide (NOx), sP-selectin, sVEGF.ConclusionsThese results, showing a reduction in the frequency of vaso-occlusive pain and a corresponding decrease in serum biomarkers of inflammation, provide preliminary clinical data to support a larger trial of simvastatin in SCD. DisclosuresStyles:Pharmacyclics LLC, an AbbVie Company: Employment.

Trajectories of postsurgical pain in children: risk factors and impact of late pain recovery on long-term health outcomes after major surgery.

Over 1 million children undergo inpatient surgery annually in the United States. Emerging research indicates that many children have longer-term problems with pain. However, limited data exist on the course of pain over time and the impact of pain recovery on long-term health outcomes. We sought to prospectively characterize children's postsurgical pain trajectories using repeated assessments over 12 months. In addition, we identified presurgical child and parent psychological risk factors associated with persistent pain and examined relationships between pain trajectories and long-term health outcomes. Sixty children aged 10 to 18 years undergoing major surgery and their parent/guardian were enrolled. Participants completed assessments at 5 time points: presurgery, inhospital, 2 weeks, 4 months, and 1 year postsurgery. Child and parent pain catastrophizing was assessed during the week before surgery. Children completed daily monitoring with an electronic pain diary and reported on pain characteristics, health-related quality of life, and activity limitations. Group-based longitudinal modeling revealed 2 distinct trajectories of postsurgical pain: early recovery (n = 49, 82%) and late recovery (n = 11, 18%). In a logistic regression model controlling for age and sex, parental pain catastrophizing before surgery significantly predicted membership in the late recovery group (odds ratio = 1.11, P = 0.03), whereas child catastrophizing and baseline pain did not (Ps < 0.05). In a multivariate regression controlling for age and sex, late pain recovery was significantly associated with poorer health-related quality of life (β = -10.7, P = 0.02) and greater activity limitations (β = 3.6, P = 0.04) at 1 year. Our findings suggest that preoperative interventions that modify parent behaviors and cognitions might be beneficial in this population.

P011. The use of electronic pain diaries via telemedicine for managing chronic pain.

Chronic pain is defined as pain that persists for longer than 3 to 6 months with persistence beyond “normal healing time” of an injury [1]. Pain is a subjective experience, which is difficult to accurately measure. Current approaches to evaluate chronic pain suffer from methodological problems. A real-time data capture approach using electronic diaries has been proposed as a new standard for pain measurement. The formulation of a correct diagnosis and the delivery of optimal care depend on accurate communication between patients and clinicians regarding patients’ symptoms that necessitate reliance on memory, which is often imprecise. Data suggest that remote clinical assessments via telemedicine can improve clinical monitoring, diagnosis and care, and facilitate research participation. Our aim was to evaluate the feasibility and the reliability of using a handheld electronic communication device via telemedicine as a method for assessing and monitoring pain and discomfort in chronic pain patients. In collaboration with TERIN, an Italian ICT (information and communication technology) consortium, we have developed an easy-to-use smartphone-based electronic pain diary (IHCS AID Diary) which enables assessment of clinical features of pain over time. Data are transferred via internet to the central server that provides the web interface to access the system (IHCS - Innovative Health Care System), to which we can connect to explore processed data and to interact with it. Fifty-three headache patients were selected. The subject's task, during pain, was to indicate the location of pain (on a bodymap), the intensity of pain (on a visual analogue scale - VAS), the state of discomfort (on the Wong-Baker FACES pain rating scale), other pain associated manifestations and therapeutic response by using the AID Diary. All subjects also completed paper pain diaries. Preliminary results showed that 27 patients (51%) were compliant in using the AID Diary during pain, 18 patients (34%) had issues with application malfunctioning and transferring data and 8 patients (15%) were noncompliant. Paper pain diaries returned by the group of compliant patients contained more errors and omissions compared to the AID Diary. The potential use of a smartphone-based electronic pain diary via telemedicine seems to be a feasible and reliable method for conducting remote assessments of clinical features of pain in chronic pain patients over time, thus improving clinical monitoring, differential diagnosis and treatment of pain. Written informed consent to publish was obtained from the patient(s).

Development, Content Validity, and User Review of a Web-based Multidimensional Pain Diary for Adolescent and Young Adults With Sickle Cell Disease.

Vaso-occlusive pain, the hallmark of sickle cell disease (SCD), is a major contributor to morbidity, poor health-related quality of life, and health care utilization associated with this disease. There is wide variation in the burden, frequency, and severity of pain experienced by patients with SCD. As compared with health care utilization for pain, a daily pain diary captures the breadth of the pain experience and is a superior measure of pain burden and its impact on patients. Electronic pain diaries based on real-time data capture methods overcome methodological barriers and limitations of paper pain diaries, but their psychometric properties have not been formally established in patients with SCD. To develop and establish the content validity of a web-based multidimensional pain diary for adolescents and young adults with SCD and conduct an end-user review to refine the prototype. Following identification of items, a conceptual model was developed. Interviews with adolescents and young adults with SCD were conducted. Subsequently, end-user review with use of the electronic pain diary prototype was conducted. Two iterative cycles of in-depth cognitive interviews in adolescents and young adults with SCD informed the design and guided the addition, removal, and modification of items in the multidimensional pain diary. Potential end-users provided positive feedback on the design and prototype of the electronic diary. A multidimensional web-based electronic pain diary for adolescents and young adults with SCD has been developed and content validity and initial end-user reviews have been completed.

“There’s an App for That”: An Interview with Dr. Jennifer Stinson, an M-Health Expert

Increased adoption of smartphone technology by the general public has opened up an exciting new means by which healthcare professionals can interact with their patients [1]. The smartphone’s unique ability to combine mobile communication and computation offers a novel modality by which physicians can deliver healthcare interventions to their patients. Thus, it is no wonder that the use of smartphones in healthcare settings (so called “m-health”) has become the focus of widespread interest amongst healthcare professionals, with many smartphone-based medical applications already in widespread use amongst physicians and patients [2]. Leading the charge in this m-health revolution is Dr. Jennifer Stinson, a nurse clinician scientist based at The Hospital for Sick Children in Toronto, who aims to capitalize on the popularity of smartphones among adolescents [3]. Dr. Stinson is a pioneer in the field of m-health, creating one of the first electronic pain diaries using the Palm Tungsten PDA to help adolescents with juvenile idiopathic arthritis (JIA) related pain [4]. More recently, she has created the “Pain Squad” smartphone-based app, a multiple award-winning pain measurement tool for children and adolescents with cancer [5].I was able to speak with Dr. Stinson about her experience with m-health, her views about the future of m-health, and her advice for interested healthcare professionals and trainees who want to integrate mobile technology into their own patient care. The following is an edited version of that conversation.

Associations of Coping Strategies with Diary Based Pain Variables Among Caucasian and African American Patients with Osteoarthritis

The purposes of this study are to examine the associations between pain coping strategies and daily diary-based pain measures and to determine whether these associations differed by race (African American and Caucasian). Primary care patients from the Durham Veterans Affairs and Duke University Medical Centers (N = 153) with hand, hip, or knee osteoarthritis (OA) completed electronic pain diaries on a one-weekend day and one weekday. The maximum, range (maximum minus minimum pain), and area under the curve (AUC) of joint pain ratings were calculated. Pain coping (Coping Strategies Questionnaire (CSQ) coping attempts, catastrophizing, and praying/hoping subscale scores) was assessed prior to diary entries and at the end of each diary day (total, problem-focused, and emotion-focused scores from Stone and Neale's Daily Coping Inventory). Pearson correlations between pain variables and coping measures were examined. Linear mixed models were fit including age, race, weekend/weekday, study enrollment site, education level, pain medication use, self-rated health, Arthritis Impact Measurement Scales affect and function subscales, and interactions of coping measures with race and weekend day/weekday status. Correlations between coping and pain measures were 0.12-0.45. In adjusted models, maximum pain and pain range were associated with all three diary-based coping measures; maximum pain was associated with CSQ coping attempts; and AUC was associated with CSQ praying/hoping. Interactions were not significant. Among participants with OA, pain coping strategies were related to important aspects of the pain experience, particularly pain range and maximum pain. However, race did not modify associations of pain coping strategy use and the pain experience.

Assessment of Pain and Activity Using an Electronic Pain Diary and Actigraphy Device in a Randomized, Placebo‐Controlled Crossover Trial of Celecoxib in Osteoarthritis of the Knee

The primary goal was to determine whether a composite measure of pain and activity is a more responsive assessment of analgesic effect than pain alone or activity alone in patients with osteoarthritis (OA) of the knee. We conducted a randomized, double-blind, placebo-controlled, 2-period, crossover study of celecoxib vs. placebo in subjects with chronic pain due to knee OA. Patients with knee OA and baseline pain intensity score ≥4 on a 0-10 numerical rating scale (NRS) before each period were randomized. Pain endpoints included in-clinic pain score (24-hour and 1-week recall), daily paper diary pain score, current pain on an electronic pain diary (each on NRS), and WOMAC pain subscale. Activity measures included WOMAC function subscale and actigraphy using a device. Three composite pain-activity measures were prespecified. Sixty-three patients were randomized and 47 completed the study. The WOMAC pain subscale was the most responsive of all five pain measures. Pain-activity composites resulted in a statistically significant difference between celecoxib and placebo but were not more responsive than pain measures alone. However, a composite responder defined as having 20% improvement in pain or 10% improvement in activity yielded much larger differences between celecoxib and placebo than with pain scores alone. Actigraphy was more responsive than the WOMAC function scale, possibly due to lower placebo responsiveness. We have identified composite pain-activity measures that are similarly or more responsive than pain-alone measures in patients with OA. Further research is warranted to determine the optimal method for computing these composites.

Evaluation of a ubiquitous and interoperable computerised system for remote monitoring of ambulatory post-operative pain: A randomised controlled trial

For economic reasons, i.e., to reduce costs of in-hospital patient accommodations, constant pressure has been applied in recent years to increase the percentage of ambulatory surgeries. Effective control of post-operative pain after ambulatory surgery is challenging to all health professionals. Computerised systems are being implemented more frequently for remote patient monitoring, including during the at-home post-operative period. This study evaluates the feasibility of delivering a computerised system, developed in-house, for remote pain monitoring. It evaluates the user-friendliness of the system and the extent of patient compliance. Finally, a comparative assessment of the system is made with respect to the quality of pain treatment in ambulatory surgery. The participants included 32 adults, aged 18-75, randomly assigned to a control group or to a computerised treatment group. The primary treatment outcome was measured by pain intensity ratings (0-10 NRS) reported several times per day during a five-day monitoring period, using an electronic pain diary combined with a web-based personal health record. The findings demonstrated the feasibility and suitability of the proposed system for pain management. Its handling was user-friendly, without requiring advanced skill or prior experience. In addition, the results showed that the guidance of health care professionals is essential to patients' satisfaction and positive experience with the system. There were no significant group differences with respect to improvements in the quality of pain treatment; however, this can be explained by the low pain scores registered in both groups, related to the type of surgical interventions recruited and the degrees of pain that are easily treated. To evaluate the benefits from a patient-centred perspective, studies of major ambulatory surgeries or of patients in chronic pain, including oncologic and non-oncologic pain resistant to treatment, are necessary.

Development, Establishment Of the Psychometric Properties and Usability Testing Of a Novel Multi-Dimensional Web Based Diary For Children With Sickle Cell Disease

BackgroundPain is the hallmark of sickle cell disease (SCD) but burden of pain is underestimated when measured using health care visits for vaso-occlusive crisis. In the PiSCES study adult patients reported pain on > 50% of diary days but sought care on only 3.5 % of diary days. Accurate assessment of the burden of pain and related morbidity is crucial in clinical care and research studies in SCD.Paper based pain diaries for assessing daily pain are limited by recall bias, errors, inflated retrospective reports and falsely high compliance due to backfilling of entries. Electronic pain diaries facilitate real-time data capture, are convenient, prevent backfilling, maximize compliance and facilitate data management. They have been used in children with arthritis, cancer, abdominal and musculoskeletal pain but no validated instrument is available for use in children with SCD. ObjectiveTo develop, establish the face and content validity, and usability of a novel web-based multidimensional electronic pain diary for children and adolescents with SCD. MethodsNeeds assessment: Pediatric subjects in a pilot SCD pain intensity diary study participated in qualitative interviews to assess their preferences regarding an electronic pain diary.Instrument development: Items for the pain diary were adapted for SCD from “e-Ouch”(c), an electronic pain diary validated for use in children with arthritis. Items assess pain intensity, duration, interference with daily tasks, sleep, fatigue, precipitating factors, pain relieving treatments and response to treatments using the Numerical Rating Scale (0-10). We created a web-based pain diary that can be accessed via a secure website using a smartphone or computer.Face validity: Experts in SCD, pain and psychometrics rated the items on a 5 point Likert scale for content, language, clinical relevance, comprehensiveness of answer choices and likely feasibility and acceptability in children with SCD. Two iterative cycles of expert review were conducted and were used for modification of items.Content validity: Using items with established face validity, two iterative cycles of testing (n=5 each) with paper screenshots of questions using semi-structured cognitive interviewing techniques were done in pediatric patients age 15-22 with SCD.Preliminary usability testing: Participants age 9-21(n=5) pilot tested the web-based electronic pain diary on a computer, smartphone and tablet. They were asked to recall their current pain and pain in the prior 12 hours while answering the diary questions. The usability testing was followed by semi-structured interviews. ResultsNeeds assessment: Patients indicated that electronic monitoring of pain could facilitate coordination of care, communication with providers and early intervention and that twice daily electronic documentation of pain would not pose an unacceptable burden.Face validity: Items were reviewed by 15 experts in the first iterative cycle and 12 experts in the second iterative cycle and were modified for language, content and relevance; 2 items were deleted and 1 item was added.Content Validity: During the first iterative cycle, participants identified items that were difficult to understand, ambiguous or irrelevant. Number of items was reduced from 18 to 13. During the second iterative cycle, one repetitive item was removed and others minimally modified. To minimize user burden items were redistributed so pain intensity, location, quality and precipitating factors were asked twice daily; effect of pain on sleep was asked in the morning and pain interference with daily activities, mood, school and interactions and clinical management items were asked in the evening.Usability testing: Participants were easily able to navigate between questions, use the 0-10 NRS slider, select affected areas on the body image and select checkbox options and provided positive feedback on the question content and, layout of the diary, ease of its use and preference for accessing it from a smartphone. ConclusionsThis study established the face and content validity and usability of a web-based multidimensional electronic pain diary developed for use in children with SCD. This instrument can be used to assess pain as a patient reported outcome in clinical trials, to enhance communication in clinical care and as a comprehensive measure of pain phenotype in mechanistic studies.▪ Disclosures:No relevant conflicts of interest to declare.

Development and Testing of a Multidimensional iPhone Pain Assessment Application for Adolescents with Cancer

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.