Children's and Caregivers' Review of a Guided Imagery Therapy Mobile App Designed to Treat Children With Functional Abdominal Pain Disorders: Leveraging a Mixed Methods Approach With User-Centered Design.

BACKGROUND: Functional abdominal pain disorders (FAPDs) are highly prevalent and associated with substantial morbidity. Guided imagery therapy (GIT) is efficacious; however, barriers often impede patient access. Therefore, we developed a GIT mobile app as a novel delivery platform. OBJECTIVE: Guided by user-centered design, this study captured the critiques of our GIT app from children with FAPDs and their caregivers. METHODS: Children aged 7 to 12 years with Rome IV-defined FAPDs and their caregivers were enrolled. The participants completed a software evaluation, which assessed how well they executed specific app tasks: opening the app, logging in, initiating a session, setting the reminder notification time, and exiting the app. Difficulties in completing these tasks were tallied. After this evaluation, the participants independently completed a System Usability Scale survey. Finally, the children and caregivers were separately interviewed to capture their thoughts about the app. Using a hybrid thematic analysis approach, 2 independent coders coded the interview transcripts using a shared codebook. Data integration occurred after the qualitative and quantitative data were analyzed, and the collective results were summarized. RESULTS: We enrolled 16 child-caregiver dyads. The average age of the children was 9.0 (SD 1.6) years, and 69% (11/16) were female. The System Usability Scale average scores were above average at 78.2 (SD 12.6) and 78.0 (SD 13.5) for the children and caregivers, respectively. The software evaluation revealed favorable usability for most tasks, but 75% (12/16) of children and 69% (11/16) of caregivers had difficulty setting the reminder notification. The children's interviews confirmed the app's usability as favorable but noted difficulty in locating the reminder notification. The children recommended adding exciting scenery and animations to the session screen. Their preferred topics were animals, beaches, swimming, and forests. They also recommended adding soft sounds related to the session topic. Finally, they suggested that adding app gamification enhancements using tangible and intangible rewards for listening to the sessions would promote regular use. The caregivers also assessed the app's usability as favorable but verified the difficulty in locating the reminder notification. They preferred a beach setting, and theme-related music and nature sounds were recommended to augment the session narration. App interface suggestions included increasing the font and image sizes. They also thought that the app's ability to relieve gastrointestinal symptoms and gamification enhancements using tangible and intangible incentives would positively influence the children's motivation to use the app regularly. Data integration revealed that the GIT app had above-average usability. Usability challenges included locating the reminder notification feature and esthetics affecting navigation. CONCLUSIONS: Children and caregivers rated our GIT app's usability favorably, offered suggestions to improve its appearance and session content, and recommended rewards to promote its regular use. Their feedback will inform future app refinements.

Management of gastroesophageal reflux disease: Patient and physician communication challenges and shared decision making.

Gastroesophageal reflux disease (GERD) is a common upper esophageal condition and typical symptoms can include heartburn and sensation of regurgitation while atypical symptoms include chronic cough, asthma, hoarseness, dyspepsia and nausea. Typically, diagnosis is presumptive given the presence of typical and atypical symptoms and is an indication for empiric therapy. Treatment management can include lifestyle modifications and/or medication therapy with proton pump inhibitor (PPI) class being the preferred and most effective. Complete symptom resolution is not always achieved and long-term PPI therapy can put patients at risk for serious side effects and needless expense. The brain-gut connection and hypervigilance plays an important role in symptom resolution and treatment success, especially in the case of non-PPI responders. Hypervigilance is a combination of increased esophageal sensory sensitivity in combination with exaggerated threat perception surrounding esophageal symptoms. Hypervigilance requires a different approach to GERD managements, where continued PPI therapy and surgery are usually not recommended. Rather, helping physicians and patients understand the brain-gut connection can guide and improve care. Education and reassurance should be the main pillars or treatment. However, it is important not to suggest the symptoms are due to anxiety alone, this often leads to patient dissatisfaction. Patient dissatisfaction with treatment reveals the need for a more patient-centered approach to GERD management and better communication between patients and providers. Shared decision making (SDM) with the incorporation of patient-reported outcomes (PRO) promotes patient adherence and satisfaction. SDM is a joint discussion between clinician and patient in which a mutually shared solution is explored for GERD symptoms. For SDM to work the physician needs to capture patients' perceptions which may not be obtained in the standard interview. This can be done through the use of PROs which promote a dialogue with patients about their symptoms and treatment priorities in the context of the SDM patient encounter. SDM could potentially help in the management of patient expectations for GERD treatment, ultimately positively impacting their health-related quality of life.

Maternal and Child Acceptability of a Proposed Guided Imagery Therapy Mobile App Designed to Treat Functional Abdominal Pain Disorders in Children: Mixed-Methods Predevelopment Formative Research.

BACKGROUND: Functional abdominal pain disorders are chronic abdominal pain conditions, which affect up to 20% of children worldwide. Of the various functional abdominal pain disorder treatment modalities, psychological therapies such as guided imagery therapy appear most effective. However, there are significant barriers to receiving psychological therapies, including access to trained therapists. Alternatively, remotely delivered psychological therapies for functional abdominal pain disorders have been efficacious. OBJECTIVE: The objective of our study was to assess acceptability of a proposed guided imagery therapy app designed to treat functional abdominal pain disorders through remote delivery of prerecorded audio sessions and to evaluate user preferences for using such an app. METHODS: Using a mixed-methods approach, we conducted a predevelopment formative study among children aged 7 to 12 years with a functional abdominal pain disorder and their parents. The parents completed our modified Technology Acceptance Model (TAM) questionnaire, which quantified behavioral intention and related factors for using a guided imagery therapy app. Dyads participated in separate in-person semistructured interviews to assess their attitudes toward and preferences for a guided imagery therapy app. Questionnaire and interview findings were collected concurrently, analyzed separately, and then integrated through methods triangulation. RESULTS: Among the 15 participating parent-child dyads, 5 (33%) children were Hispanic and 11 (73%) had irritable bowel syndrome. They had diverse socioeconomic status. All parent participants were mothers. The TAM questionnaire indicated that mothers scored favorably on behavioral intention to use a guided imagery therapy app (mean score 12.0, SD 2.6, possible range 3-15). Scores for the TAM factors perceived usefulness, perceived ease of use, hedonic motivation, compatibility, and habit also were favorable. Maternal interviews confirmed positive attitudes toward the proposed app. They advocated a visual component to hold their child's attention during the guided imagery therapy sessions; recommended incorporating background sounds into the sessions; favored session reminder notifications from the app; and thought the best time for their child to listen to the sessions would be in the evening or before bed. The child interviews also confirmed positive attitudes toward the proposed app. They suggested guided imagery therapy session topics such as sports and adventures; listening to sessions in their bedroom; and the need for parental supervision to install the app on their mobile device. Integration of the quantitative and qualitative methods findings complimented one another on acceptability. The favorable behavioral intention TAM score aligned well with expressed positive maternal and child attitudes toward the app and can be explained by the desire to avoid medications. The questionnaire and interviews also confirmed therapeutic benefit as an intrinsic motivator to promote routine use. CONCLUSIONS: A guided imagery therapy app designed to treat pediatric patients with functional abdominal pain disorders appears to be acceptable to both mothers and children. Incorporating parent and child preferences into a guided imagery therapy app could promote therapeutic compliance and increase access to optimal care.

Opioids for chronic non-cancer pain in children and adolescents.

BACKGROUND: Pain is a common feature of childhood and adolescence around the world, and for many young people, that pain is chronic. The World Health Organization guidelines for pharmacological treatments for children's persisting pain acknowledge that pain in children is a major public health concern of high significance in most parts of the world. While in the past, pain was largely dismissed and was frequently left untreated, views on children's pain have changed over time, and relief of pain is now seen as importantWe designed a suite of seven reviews on chronic non-cancer pain and cancer pain (looking at antidepressants, antiepileptic drugs, non-steroidal anti-inflammatory drugs, opioids, and paracetamol as priority areas) in order to review the evidence for children's pain utilising pharmacological interventions in children and adolescents.As the leading cause of morbidity in children and adolescents in the world today, chronic disease (and its associated pain) is a major health concern. Chronic pain (lasting three months or longer) can arise in the paediatric population in a variety of pathophysiological classifications: nociceptive, neuropathic, idiopathic, visceral, nerve damage pain, chronic musculoskeletal pain, and chronic abdominal pain, and other unknown reasons.Opioids are used worldwide for the treatment of pain. They bind to opioid receptors in the central nervous system (mu, kappa, delta, and sigma) and can be agonists, antagonists, mixed agonist-antagonists, or partial agonists. Opioids are generally available in healthcare settings across most high-income countries, but access may be restricted in low- and middle-income countries. For example, opioids currently available in the UK include: buprenorphine, codeine, fentanyl, hydromorphone, methadone, morphine, oxycodone, and tramadol. Opioids are used in varying doses (generally based on body weight for paediatric patients) by means of parenteral, transmucosal, transdermal, or oral administration (immediate release or modified release). To achieve adequate pain relief in children using opioids, with an acceptable grade of adverse effects, the recommended method is a lower dose gradually titrated to effect in the child. OBJECTIVES: To assess the analgesic efficacy and adverse events of opioids used to treat chronic non-cancer pain in children and adolescents aged between birth and 17 years, in any setting. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL) via the Cochrane Library, MEDLINE via Ovid, and Embase via Ovid from inception to 6 September 2016. We also searched the reference lists of retrieved studies and reviews, and searched online clinical trial registries. SELECTION CRITERIA: Randomised controlled trials, with or without blinding, of any dose and any route, treating chronic non-cancer pain in children and adolescents, comparing opioids with placebo or an active comparator. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed studies for eligibility. We planned to use dichotomous data to calculate risk ratio and number needed to treat, using standard methods. We assessed GRADE (Grading of Recommendations Assessment, Development and Evaluation) and planned to create a 'Summary of findings' table. MAIN RESULTS: No studies were eligible for inclusion in this review. We rated the quality of the evidence as very low. We downgraded the quality of evidence by three levels due to the lack of data reported for any outcome. AUTHORS' CONCLUSIONS: There was no evidence from randomised controlled trials to support or refute the use of opioids to treat chronic non-cancer pain in children and adolescents. We are unable to comment about efficacy or harm from the use of opioids to treat chronic non-cancer pain in children and adolescents.We know from adult randomised controlled trials that some opioids, such as morphine and codeine, can be effective in certain chronic pain conditions.This means that no conclusions could be made about efficacy or harm in the use of opioids to treat chronic non-cancer pain in children and adolescents.

Quantitative pedigree analysis and mitochondrial DNA sequence variants in adults with cyclic vomiting syndrome.

BACKGROUND: Children with cyclic vomiting syndrome (CVS) have a high degree of maternal inheritance of functional gastrointestinal and neurological disorders. CVS in children is also associated with an increased prevalence of mitochondrial DNA single-nucleotide polymorphisms (mtDNA SNPs) 16519 T and 3010A. Preliminary data suggests that age of onset of symptoms (pediatric vs. adult) may be a determinant of the presence of such mtDNA SNP's. We sought to examine the degree of maternal inheritance pattern of functional disorders and the prevalence of mtDNA SNP's16519T and 3010A in adults with CVS and correlate this with age of onset of disease. METHODS: A Quantitative Pedigree Analysis (QPA) was performed in 195 of a total of 216 patients and all were genotyped using Restriction Fragment Length Polymorphism (RFLP) or sequencing. RESULTS: Adults with CVS had a higher degree of probable maternal inheritance (PMI) of functional disorders than controls (12% vs. 1%, p < 0.001). However, the prevalence of mitochondrial SNP's 16519 T, 3010A and the AT genotype were similar in Haplogroup H CVS patients compared to historical controls. There was no correlation between age of onset of disease and prevalence of these mtDNA SNP's. CONCLUSIONS: A subset of adults with CVS has a significantly higher degree of maternal inheritance pattern of functional disorders than controls. There was no association with mtDNA SNP's 16519 T and 3010A as seen in children and future studies sequencing the entire mitochondrial and nuclear genome to identify potential causes for this maternal inheritance pattern in adults are warranted.