Electronic Diary Research Articles

Napping behavior in adults with episodic migraine: a six-week prospective cohort study.

Patients with migraine commonly endorse napping as a strategy for headache pain relief, but also experience high rates of sleep disturbance. To elucidate the relationship between napping behavior and migraine, we evaluated the association between napping and headache frequency, severity, and intensity among adults with episodic migraine. We also examined the association between daily napping and that night's sleep. In this six-week prospective cohort study, 97 adults with episodic migraine completed twice-daily headache and sleep electronic diaries and wore a wrist actigraph. We modeled the associations between napping (yes/no) and headaches with conditional logistic regression and daily napping and nighttime sleep with linear regression. Over 4,353 study days, participants reported 1,059 headache days and 389 days with naps. More than 80% of participants napped during the study, with mean nap duration of 76.7 ± 62.4 min. Naps were more likely to occur on day 2 of headache 35/242 (14.5%) than on nonheadache days 279/3294 (8.5%, OR 2.2 [95% CI 1.4, 3.4]). Mean nap onset time (14:40 ± 3.3 h) was later than headache onset (12:48 ± 5.3 h). In adjusted models, napping was associated with an additional 1.1 (95% CI -1.4, 3.6) headache days/month. Naps were not associated with worse self-reported or objective sleep that night. Our findings suggest that naps may be an uncommonly used behavioral strategy for prolonged migraine attacks and do not contribute to nightly sleep disturbance. Future studies are needed to examine the acute analgesic effects of daytime napping in patients with migraine.

Safety and Efficacy of Damoctocog Alfa Pegol Prophylaxis in Patients with Severe Hemophilia A: Interim Results of a Post-Marketing, Interventional Study

BackgroundDamoctocog alfa pegol (BAY 94-9027, Jivi®) is an approved factor (F)VIII treatment indicated for use in previously treated patients with hemophilia A aged ≥12 years, based on its safety and efficacy profile as demonstrated in the PROTECT VIII trial (NCT01580293).Here, we report preliminary results of a post-marketing interventional study of damoctocog alfa pegol prophylaxis in previously FVIII-treated patients with severe hemophilia A aged ≥18 years.MethodsThis is an ongoing, multicenter, single group, uncontrolled, open-label, post-marketing, interventional, phase IV trial (NCT04085458) of damoctocog alfa pegol in previously FVIII-treated patients with severe hemophilia A, aged ≥18 years (Figure 1). Eligible patients receive prophylaxis with damoctocog alfa pegol for 100 exposure days (EDs), starting with 45 IU/kg every 5 days (E5D) (recommended dose) or 40 IU/kg twice-weekly (2×W) until their next planned visit (Visit 3 after 10-15 EDs). At Visit 3, patients can either continue with the same regimen, increase their dose, or switch regimen to 2×W, E5D, or every 7 days (E7D), based on their needs as judged by the investigator. Patients who switched prophylaxis regimen after their third visit were assigned to a variable frequency (VAR) group. Patients with ≥1 infusion of damoctocog alfa pegol and bleeding data for ≥3 months were eligible for inclusion in the modified intent-to-treat cohort and are included in this interim analysis.Primary endpoint is FVIII inhibitor development (titer ≥0.6 Bethesda units). Secondary endpoints include treatment emergent adverse events (TEAE), anti-PEG (polyethylene glycol) antibody development and annualized bleeding rate (ABR). Bleeds and study drug consumption were recorded using an electronic patient diary. All analyses are exploratory.ResultsBy June 1, 2021, 32 patients have been enrolled. Of these, 30 patients have had ≥1 infusion of damoctocog alfa pegol and bleeding data for ≥3 months, and are thus included in this analysis (2×W, n = 7; E5D, n = 8; E7D, n = 9; VAR, n = 6). Median (range) age at start of FVIII treatment was 5.0 (0-15.0) years, with the majority (n = 24; 80.0%) starting with an on-demand regimen. Median (range) age for starting prophylaxis was 32.0 (0-64) years. At data cutoff, median (range) total time in study was 422 (112-554) days and 87 (30-114) EDs. Safety data are presented in Table 1. No patients developed FVIII inhibitors, PEG antibodies or anti-drug antibodies. Sixteen (53.3%) patients developed TEAE, with the majority being mild in severity (n = 12, 40.0%). Three (10.0%) patients experienced mild or moderate TEAEs, which were considered study drug-related by the investigator. At data cutoff, median (quartile, [Q]1; Q3) total and joint ABRs were 1.82 (0.7; 5.5) and 0.37 (0.0; 2.6), respectively. Of 20 patients who were treated for ≥12 months, 30% (n = 6) had zero total bleeds and 60% (n = 12) had zero joint bleeds in their last year of treatment.ConclusionsPreliminary results from 30 patients observed for up to 80 weeks show that individualized prophylaxis regimens of damoctocog alfa pegol were well tolerated in this post-marketing study. No immunogenicity concerns were observed, with no patients developing FVIII inhibitors, anti-PEG or anti-drug antibodies. Despite many patients starting prophylaxis late, ABRs were low and a large proportion achieved zero bleeds. These data support the favorable safety and efficacy profile of damoctocog alfa pegol prophylaxis in routine clinical use. [Display omitted] DisclosuresHolme: Bayer, Octapharma, Pfizer and Shire: Research Funding; Bayer, Novo Nordisk, Octapharma, Pfizer, Shire and Sobi: Consultancy. Hvitfeldt Poulsen: Pfizer: Research Funding; Bayer, Novo Nordisk, Sobi, Pfizer, Octapharma: Other: Congress Support. Tueckmantel: Bayer: Current Employment. Alvarez Roman: Amgen, Bayer, CSL Behring, Novartis, Novo Nordisk, Shire/Takeda, Sobi, Roche: Speakers Bureau; Shire/Takeda: Research Funding. De Cristofaro: Shire/Takeda: Research Funding; Bayer, Takeda: Consultancy; Bayer: Other: Congress Support; Sobi: Consultancy.

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.

Defining clinically important hypoglycemia in patients with postbariatric hypoglycemia.

Postbariatric hypoglycemia (PBH) is a rare but growing complication of bariatric surgery. Many aspects have yet to be established, including the blood glucose threshold which represents clinically important hypoglycemia in affected patients. To confirm the glucose threshold below which neuroglycopenic (NG) symptoms arise in patients with PBH during provoked and real-world hypoglycemia as an indicator of clinically important hypoglycemia. Stanford University School of Medicine. Forty patients with PBH were enrolled. Thirty-two patients underwent hypoglycemia provocation in the clinical research unit (CRU) during which symptoms and blood glucose concentrations were assessed. A sensitivity analysis and stepwise linear regression were conducted evaluating relationships between symptoms and glucose levels. To validate CRU findings in the real-world setting, 8 sex-, age-, body mass index (BMI)-, and disease severity-matched patients underwent 20 days of at-home continuous glucose monitoring (CGM), self-monitoring of blood glucose (SMBG), and symptom assessment by electronic diary (eDiary). In response to hypoglycemia provocation 19%, 59%, and 22% of patients developed a postprandial glucose nadir <70-54 mg/dL , <54-40 mg/dL, and <40 mg/dL, respectively. Number of NG symptoms was highest when glucose was in the <54-40 mg/dL range, although 23% of those with NG symptoms in this range, and 37% with NG symptoms below this range lacked autonomic symptoms, indicating substantial hypoglycemia unawareness. Sensitivity of symptoms to detect hypoglycemia was poor other than for drowsiness, while specificity was high for all NG symptoms. Confusion, sweating, drowsiness, and incoordination were significant independent predictors of hypoglycemia. Events captured during real-world monitoring mirrored CRU data, showing a spike in NG symptoms in the <54-40 mg/dL range. CGM captured up to 10-fold more events than were patient-perceived and captured by SMBG/eDiary. Due to the peak in NG symptoms at glucose <54-40 mg/dL during provoked and real-world hypoglycemia, the low sensitivity/high specificity of NG symptoms to detect hypoglycemia, and high prevalence of hypoglycemia unawareness at glucose values <54 mg/dL, we propose that blood glucose <54 mg/dL should be taken to signify clinically important hypoglycemia in patients with established PBH.

Using Telehealth to Deliver Family-Based Cognitive Behavioral Treatment of Insomnia in a School-Aged Child With Autism Spectrum Disorder.

Chronic insomnia (>3 months) is common in children with autism. Cognitive behavioral treatment for insomnia in children (CBT-CI) holds promise for improving sleep and daytime functioning in school-aged children with autism and their parents, but typical delivery involving multiple in-person office visits limits accessibility. This case study describes telehealth delivery of CBT-CI (teleCBT-CI) with a 7-year 4-month-old biracial boy with autism spectrum disorder (ASD) and insomnia and his parents. He and his mother wore actigraphs and completed electronic sleep diaries for 2 weeks, and his mother completed the Aberrant Behavior Checklist at pre/post/1-month follow-up. He and both of his parents completed eight telehealth treatment sessions. TeleCBT-CI improved the boy's sleep (objective, subjective) and decreased irritability, lethargy, stereotypy, and hyperactivity. This case study shows that teleCBT-CI is feasible and can improve child sleep and functioning.

Amoxicillin duration and dose for community-acquired pneumonia in children: the CAP-IT factorial non-inferiority RCT.

Data are limited regarding the optimal dose and duration of amoxicillin treatment for community-acquired pneumonia in children. To determine the efficacy, safety and impact on antimicrobial resistance of shorter (3-day) and longer (7-day) treatment with amoxicillin at both a lower and a higher dose at hospital discharge in children with uncomplicated community-acquired pneumonia. A multicentre randomised double-blind 2 × 2 factorial non-inferiority trial in secondary care in the UK and Ireland. Paediatric emergency departments, paediatric assessment/observation units and inpatient wards. Children aged > 6 months, weighing 6-24 kg, with a clinical diagnosis of community-acquired pneumonia, in whom treatment with amoxicillin as the sole antibiotic was planned on discharge. Oral amoxicillin syrup at a dose of 35-50 mg/kg/day compared with a dose of 70-90 mg/kg/day, and 3 compared with 7 days' duration. Children were randomised simultaneously to each of the two factorial arms in a 1 : 1 ratio. The primary outcome was clinically indicated systemic antibacterial treatment prescribed for respiratory tract infection (including community-acquired pneumonia), other than trial medication, up to 28 days after randomisation. Secondary outcomes included severity and duration of parent/guardian-reported community-acquired pneumonia symptoms, drug-related adverse events (including thrush, skin rashes and diarrhoea), antimicrobial resistance and adherence to trial medication. A total of 824 children were recruited from 29 hospitals. Ten participants received no trial medication and were excluded. Participants [median age 2.5 (interquartile range 1.6-2.7) years; 52% male] were randomised to either 3 (n = 413) or 7 days (n = 401) of trial medication at either lower (n = 410) or higher (n = 404) doses. There were 51 (12.5%) and 49 (12.5%) primary end points in the 3- and 7-day arms, respectively (difference 0.1%, 90% confidence interval -3.8% to 3.9%) and 51 (12.6%) and 49 (12.4%) primary end points in the low- and high-dose arms, respectively (difference 0.2%, 90% confidence interval -3.7% to 4.0%), both demonstrating non-inferiority. Resolution of cough was faster in the 7-day arm than in the 3-day arm for cough (10 days vs. 12 days) (p = 0.040), with no difference in time to resolution of other symptoms. The type and frequency of adverse events and rate of colonisation by penicillin-non-susceptible pneumococci were comparable between arms. End-of-treatment swabs were not taken, and 28-day swabs were collected in only 53% of children. We focused on phenotypic penicillin resistance testing in pneumococci in the nasopharynx, which does not describe the global impact on the microflora. Although 21% of children did not attend the final 28-day visit, we obtained data from general practitioners for the primary end point on all but 3% of children. Antibiotic retreatment, adverse events and nasopharyngeal colonisation by penicillin-non-susceptible pneumococci were similar with the higher and lower amoxicillin doses and the 3- and 7-day treatments. Time to resolution of cough and sleep disturbance was slightly longer in children taking 3 days' amoxicillin, but time to resolution of all other symptoms was similar in both arms. Antimicrobial resistance genotypic studies are ongoing, including whole-genome sequencing and shotgun metagenomics, to fully characterise the effect of amoxicillin dose and duration on antimicrobial resistance. The analysis of a randomised substudy comparing parental electronic and paper diary entry is also ongoing. Current Controlled Trials ISRCTN76888927, EudraCT 2016-000809-36 and CTA 00316/0246/001-0006. This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 60. See the NIHR Journals Library website for further project information.

Safety and efficacy of remote electrical neuromodulation for the acute treatment of chronic migraine: an open-label study.

Remote electrical neuromodulation (REN) is an acute treatment of migraine. The results from several studies in patients with episodic migraine suggest that REN is an effective and safe acute treatment of migraine. A recent pilot study provided initial support that REN is effective in patients with chronic migraine as well. The current study aimed to validate and provide further evidence for the safety and efficacy of REN in a large sample of patients impacted by chronic migraine. In this open-label, single-arm study, patients with chronic migraine treated their headaches with the REN device (Nerivio, Theranica Bio-Electronics Ltd, Israel) for 4 weeks. Participants used an electronic diary to record their symptoms at treatment initiation, 2 hours after treatment, and 24 hours after treatment. The primary end point was the percentage of subjects who achieved pain relief at 2 hours posttreatment. Secondary end points included pain freedom and improvement of associated symptoms and functional disability. One hundred twenty-six subjects were enrolled into the study, of which 91 subjects had an evaluable treatment with REN. Pain relief and pain disappearance at 2 hours were achieved by 59.3% (54/91) and 20.9% (19/91) of modified intent-to-treat subjects, respectively (with worst-case sensitivity analysis indicating 54.5% and 19.2%, respectively). Sustained pain relief at 24 hours was observed in 64.4% (29/45) of those who achieved pain relief at 2 hours (with worst-case sensitivity analysis indicating 45.6%). The findings of the study show that REN has a favorable effect on nausea, photophobia, and phonophobia and improves functional ability. One device-related adverse event was reported. Remote electrical neuromodulation treatments results in the relief of migraine headaches and associated symptoms, thus offering a drug-free acute treatment option for people with chronic migraine. ClinicalTrials.gov NCT04194008.

The Use of the Electronic Diary Food (EDIFO) Application and Their Effect on the Attitude of Pregnant Mothers

Balanced nutrition is beneficial for physical growth and development, maintaining health, replacing body tissues, and supporting reproductive health. There are several things that need to be considered during pregnancy, including nutritional needs during pregnancy which are different for each individual and one of them is influenced by health history and previous nutritional status. To help pregnant women control their nutritional needs and solve the problems above, an Electronic Diary Food (EDIFO) application will be created as an information system for balanced nutrition intake for pregnant women. A pregnant woman can access a balanced nutrition information system application anywhere and anytime. The application can be used by all pregnant women as long as the pregnant women can connect to the internet and are able to use the internet.

Daily stress and sleep associations vary by work schedule: A between- and within-person analysis in nurses.

Nurses experience poor sleep and high stress due to demanding work environments. Night shift work is common among nurses and may exacerbate stress-sleep associations. We examined bidirectional associations between daily stress and sleep, and moderation by recent shift worker status and daily work schedule among nurses. Participants were 392 nurses (92% female; 78% White, mean age=39.54, SD=11.15) who completed 14days of electronic sleep diaries and actigraphy. They simultaneously completed assessments of daily stress and work schedule upon awakening (day shift vs. night shift [work between 9p.m.-6a.m.] vs. off work). Participants were classified as recent night shift workers if they worked at least one night shift during the past 14days (n=101; 26%). In the entire sample, greater daily stress predicted shorter self-reported total sleep time and lower self-reported sleep efficiency that night. Shorter self-reported and actigraphy total sleep time and lower self-reported sleep efficiency predicted higher next-day stress. Compared with recent night shift workers, day workers reported higher stress after nights with shorter total sleep time. Stress-sleep associations mostly did not vary by nurses' daily work schedule. Sleep disturbances and stress may unfold in a toxic cycle and are prime targets for tailored interventions among nurses. Night shift workers may be less susceptible to the effects of short sleep on next-day stress. Research is needed to understand the short- and long-term effects of shift work and address the unique sleep challenges nurses face.

Association of parental and adolescent emotion-related factors with adolescent chronic pain behaviors.

Chronic pain is a prevalent condition in youth, and the pain experience is strongly influenced by emotional processes. Studying emotion variability and regulation (ER) may help better understand pain behavior. As the development of emotion-related abilities predominantly takes place in the family context, examining ER within parent-adolescent dyads is important. We set out to test the association of parent and adolescent ER and adolescent emotional variability with adolescent pain behavior (ie, pain interference, activity avoidance, and activity engagement). A sample of 56 adolescents (Mage = 14.5, 85.7% women) with chronic pain and one of their parents (92.9% mothers) participated in this study. Adolescents completed baseline measures of average pain intensity, ER, and mean positive and negative affect. Furthermore, adolescents completed an electronic diary for 14 consecutive days, reporting on emotional state, activity avoidance, activity engagement, and pain interference. Parents completed measures of ER and their own history of pain. We performed a variable selection procedure, the least absolute shrinkage and selection operator method, to determine important predictors of adolescent pain behavior. Adolescent high positive affect was associated with more activity engagement, less pain interference, and less activity avoidance, indicating that positive affect might enhance the willingness to engage in activities in the presence of pain. Adolescent ER strategy emotional reappraisal and parents' own history of pain were predictors of less activity engagement. Parent ER was not related to adolescent ER. In conclusion, our results highlight the potential of enhancing positive affect as an intervention target for chronic pain.

The impact of a digital wheeze detector on parental disease management of pre-school children suffering from wheezing\u2014a pilot study

BackgroundViral airway infections are a major reason for doctor’s visits at pre-school age, especially when associated with wheezing. While proper treatment requires adequate recognition of airway obstruction, caretakers are often struggling with this judgment, consequently leading to insufficient or late treatment and an unnecessary discomfort of the patient. Digital technologies may serve to support parental decision taking. The aim of the present pilot study is to acquire data on the feasibility of recruitment and observation procedures for a randomized controlled trial on the impact of a digital wheeze detector in a home management setting of pre-school wheezing.MethodsThis single-armed pilot study enrolled patients with a doctor’s diagnosis of wheezing aged 9 to 72 months. Participants were asked to use a digital wheeze detector (WheezeScan, Omron Healthcare, Japan) 2×/day for 30 days and record the child’s respiratory symptoms, detection of wheezing, and medication intake via an electronic diary (eDiary) app. Demographic and clinical data were collected at the recruitment visit. The asthma control test and the Parent Asthma Management Self-Efficacy Scale (PAMSES) were assessed both, at recruitment and follow-up.ResultsTwenty families were recruited and completed the monitoring. All but one completed the follow-up after 30 days. The recruitment procedures were feasible, and adherence to daily monitoring reached an average of 81%. The use of the wheeze detector was rated as uncomplicated. Parents detected wheezing without digital support in only 22/708 (3.1%) of the recorded events. By contrast, the wheeze detector indicated an airway obstruction in 140/708 (19.8%) of the recordings.ConclusionIn parallel to feasible recruitment procedures, we observed good usability of the wheeze detection device and high adherence to eDiary recording. The positive outcomes show that the WheezeScan may empower parents by increasing their capacity for wheeze detection. This deserves to be investigated in a larger randomized controlled trial.

Anti-CGRP monoclonal antibodies in chronic migraine with medication overuse: real-life effectiveness and predictors of response at 6\u2009months

BackgroundIn daily practice, anti-CGRP monoclonal antibodies (MAbs) may be useful in chronic migraine (CM) with medication overuse (MO), but data is limited. We evaluated their effectiveness in a real-life clinical cohort.MethodsThis is a prospective study conducted in CM patients with and without medication overuse treated with monthly MAbs during 6 months (erenumab/galcanezumab). We collected headache characteristics, including acute medication intake, through an electronic diary. We compared patients (1) with and without MO at baseline, (2) with and without ongoing MO after treatment, defining MO resolution as < 10 or 15 days/month of acute medication intake, according to analgesic type, during the 6-month treatment.ResultsOf 139 CM patients completing 6-month treatment with anti-CGRP MAbs, 71.2% (99/139) had MO at baseline. After 6 months, patients with and without MO at baseline had significant and similar proportions of ≥50% reduction in migraine days/month (MO: 63.6% vs. non-MO: 57.5%, p = 0.500). 60.6% (60/99) no longer satisfied MO definition. Reduction in headache frequency compared to baseline occurred in both MO-ongoing and MO-resolution group, although those who stopped overusing had a greater improvement (headache days/month: − 13.4 ± 7.6 vs. -7.8 ± 7.2, p < 0.0001). No differences in MO resolution were observed according to the MAbs used. Baseline lower pain severity was associated with MO resolution (OR [95%]:0.236[0.054–0.975]; p = 0.049).ConclusionsIn real-life anti-CGRP MAbs are as effective in CM patients with MO as in patients without it and facilitate MO cessation. Reduction in headache frequency and acute medication days/month occurs regardless of whether patients stop overusing or not.

S906 Clinical Remission Using the Patient-Reported Ulcerative Colitis Electronic Diary (UC e-Diary) in Adults With Moderate-to-Severe Ulcerative Colitis

S906 Clinical Remission Using the Patient-Reported Ulcerative Colitis Electronic Diary (UC e-Diary) in Adults With Moderate-to-Severe Ulcerative Colitis

WHEN A VIDEO GAME BECOMES THE TREATMENT: HARNESSING DIGITAL AND SCREEN TECHNOLOGY AS THERAPEUTIC MODALITIES IN CHILD AND ADOLESCENT PSYCHIATRY

Objectives: American teens consume approximately 7 hours of screen time daily, with use extending into social, recreational, and academic spheres of life. Youth also appear increasingly invested in using digital media to address health issues, with 64% reporting the use of a mobile app for health-related purposes. As their patients become more reliant on the use of screens, it is incumbent on child and adolescent mental health professionals to understand evolving digital technologies and their potential role in mental health treatment. The presentation’s overall objectives are both to review the most salient examples of mobile health (mHealth) technologies useful in the clinical encounter and to guide participants through how to make informed recommendations surrounding the use of mHealth technology. Methods: Specifically, this presentation explores the use of video games in psychotherapeutic treatment, including case studies to exemplify this practice, as well as the use of varying mHealth technologies (eg, digital phenotyping, electronic diary cards). Programs will review each technology’s potential risks and benefits. The presentation will also use a mixed didactic and interactive approach to guide participants through specific treatment decisions regarding incorporation of these technologies into the treatment setting (including through use of an online decision-making tool). Results: Psychiatrists have begun exploring clinical use of novel mHealth technologies. However, through its emphasis on remote forms of mental health care, the COVID-19 pandemic has forced more expedient clinical adoption of these novel technologies. Overall, treatments that incorporate video gaming, behavioral health apps, and apps that collect survey and phone sensor data appear feasible and acceptable to young patients;however, recommendation of a particular technology relies on cautious, calculated decision making. Conclusions: The patients of child and adolescent psychiatrists are rapidly adapting to new digital technologies, increasingly incorporating them into their lives, including their health. Adoption of mHealth technology has the potential to improve quality and facilitate obtainment of important clinical information. Mental health professionals should become proficient in both using and discussing mHealth technologies with their patients. TREAT, COMP, TVM

S905 Psychometric Properties of the Ulcerative Colitis Electronic Diary (UC e-Diary) in Adult Patients with Moderate-to-Severe Ulcerative Colitis

S905 Psychometric Properties of the Ulcerative Colitis Electronic Diary (UC e-Diary) in Adult Patients with Moderate-to-Severe Ulcerative Colitis

Association Between Proposed Definitions of Clinical Remission/Response and Well-Being in Patients With Crohn's Disease.

Background and AimsPatient-reported outcomes are recommended endpoints in Crohn’s disease [CD] trials. The association between patient-reported general well-being relative to symptoms of diarrhoea and abdominal pain [AP] in patients with moderate to severe CD was explored.MethodsPatients from three randomized, placebo-controlled, double-blind adalimumab or upadacitinib studies with average daily very soft/liquid stool frequency [SF] ≥4 and/or AP score ≥2 at baseline were included. Using electronic diaries, patients reported general well-being [seven-point Likert scale; 1 = worst; 7 = best] in item 10 of the Inflammatory Bowel Disease Questionnaire [IBDQ]. Changes in well-being and clinical outcomes of SF and AP from baseline to week 12 or 16, and the relationship between well-being and clinical outcomes were evaluated using cumulative distribution function and probability density function curves.ResultsIn total, 858 patients with CD were included [adalimumab, n = 695; upadacitinib, n = 163]. Patients who achieved clinical remission [SF ≤2.8, AP score ≤1.0, neither worse than baseline] were more likely than those not in clinical remission to report IBDQ item 10 response in the 6–7 group category but not IBDQ categories ≤5. Higher IBDQ score for item 10 [6–7] was associated with lower SF and AP score. Greater point increases in IBDQ item 10 were associated with a greater percentage decrease in clinical parameters; a ≥25–30% decrease in SF or AP was associated with a ≥1-point improvement in IBDQ.ConclusionsAn association between improvements in patient-reported general well-being and clinical remission/response was observed using outcomes of SF and AP, supporting the clinical remission/response endpoint definitions used in clinical studies of CD. Clinical Trial Registrations [ClinicalTrials.gov]: NCT00077779 [CHARM]; NCT00348283 [EXTEND]; NCT02365649 [CELEST].

Treatment with the monoclonal calcitonin gene-related peptide receptor antibody erenumab: A real-life study.

Background and purposeNew prophylactics for migraine, targeting calcitonin gene‐related peptide (CGRP), have recently emerged. Real‐world data are important for a comprehensive understanding of treatment response. We assessed the consistency of response to erenumab, a monoclonal CGRP receptor antibody, in a real‐world setting, in order to determine which patients may be considered responders in clinical practice.MethodsAll erenumab‐treated patients (n = 100) completed a time‐locked daily electronic diary, and an automated algorithm was used to monitor treatment response. Monthly migraine days (MMD), non‐migrainous headache days, days of acute medication use (MAMD), well‐being and coping with pain were assessed for a 6‐month period. The primary outcome was reduction in MMD compared to baseline.ResultsThe numbers of MMD and MAMD decreased in all months, in both episodic and chronic migraine patients, compared to baseline (p < 0.001), while general well‐being (p < 0.001) and coping with pain (p < 0.001) also improved. Of all patients, 36% had an MMD reduction of ≥50% in ≥3/6 months, and 6% had such a reduction in all 6 months. For a ≥30% MMD reduction, the figures were 60% and 24%, respectively. Almost 90% of patients with an average MMD reduction of ≥30% over the first 3 months had a sustained response in the last 3 months. In addition, 20% of patients without an initial response (average <30%), had a delayed response (average ≥30%) in the last 3 months.ConclusionErenumab was effective in migraine patients who were highly refractory to previous prophylactics. As a practical guideline, we propose that treatment be continued for at least 6 months and that patients with a ≥30% MMD reduction in at least half of the treatment period should be considered to be responders.

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

A phase 4 study of the safety of the 13-valent pneumococcal conjugate vaccine in children 6 to 17 years of age in India

PurposeThe 13-valent pneumococcal conjugate vaccine (PCV13) was recently approved in India for the prevention of pneumococcal disease in children aged 6 to 17 years based on global data as well as immunogenicity and safety findings from a phase 3 study. The current phase 4 study in India further evaluated the safety profile of PCV13 in this age group to support the positive benefit-risk profile of PCV13. MethodsHealthy male and female children aged 6 to 17 years in India were administered a single intramuscular injection of PCV13. Through 7 days after PCV13 administration, local reactions and systemic events were recorded daily by caregivers in an electronic diary. Adverse events (AEs) were collected from the provision of informed consent through 28–42 days postvaccination. ResultsOne hundred subjects enrolled in and completed the study. After PCV13 vaccination, 73.9% and 57.8% of subjects reported local reactions and systemic events, respectively. The majority of reactogenicity events were mild to moderate in severity, with injection site pain and fatigue the most frequently reported local reaction and systemic event, respectively. Six subjects reported 7 AEs, all of which were considered unrelated to PCV13. One subject reported a serious AE (acute hepatitis), which was considered unrelated to PCV13 and ultimately resolved. No subjects withdrew because of AEs, and there were no deaths. ConclusionPCV13 vaccination was well tolerated with an acceptable safety profile in healthy subjects aged 6 to 17 years in India. This work further supports the safety profile of PCV13 for prevention of pneumococcal disease in this age group in India.

Coping motives and negative affect: An ecological study of the antecedents of alcohol craving and alcohol use.

Negative affect (NA) is presumed to be an important trigger for drinking, particularly among coping-motivated drinkers. However, diary studies attempting to predict alcohol use from interactions between state NA and coping motives have proved inconsistent. Craving or momentary desire for alcohol may be a more proximal and robust consequence of NA in coping-motivated drinkers. Data were drawn from an ecological momentary assessment investigation. Frequent drinkers (N = 403) carried electronic diaries for 21 consecutive days, recording their drinking behavior, and rating cravings for alcohol and NA. Outside of active drinking episodes, within-person elevations of momentary NA were associated with increased craving intensity, and this effect was more prominent among drinkers with higher dispositional coping motives. There was no significant interaction between coping motives and momentary NA in predicting the occurrence and amount of same-day alcohol use. Significant conditional indirect effects indicated that NA promoted drinking through increases in craving. These indirect effects were stronger among drinkers reporting higher coping motives. Coping motives and within-person fluctuations in NA interactively predict alcohol craving. NA promotes drinking indirectly via increased craving, particularly among coping-motivated drinkers. Alcohol craving may be a proximal and sensitive response channel for investigating interactions between affective distress and coping motives. (PsycInfo Database Record (c) 2021 APA, all rights reserved).