Electronic Diary Research Articles

0407 Early Efficacy With Once-Nightly Sodium Oxybate (ON-SXB; FT218): Post-hoc Analyses From REST-ON

Abstract Introduction Extended-release once-nightly sodium oxybate (ON-SXB; FT218) is in development for adults with narcolepsy. In REST-ON, significant improvements on the Maintenance of Wakefulness test, Clinical Global Impression of Improvement rating, and number of weekly cataplexy episodes occurred with all analyzed ON-SXB doses vs placebo (week 3, 6-g dose; week 8, 7.5-g dose; week 13, 9-g dose; all P<0.001). ON-SXB was superior to placebo on Epworth Sleepiness Scale (ESS) score and sleep quality and refreshing nature of sleep using visual analog scales (VAS; all P<0.001). ON-SXB 4.5 g significantly reduced cataplexy episodes vs placebo at week 1 (P<0.05). Post hoc analyses investigated ON-SXB efficacy on ESS score, VAS sleep quality, and VAS refreshing nature of sleep at weeks 1 and 2. Methods Participants in the double-blind, phase 3 REST-ON (NCT02720744) trial were ≥16 years old, had narcolepsy type 1 or 2, and were randomized 1:1 to ON-SXB (4.5 g, 1 week; 6 g, 2 weeks; 7.5 g, 5 weeks; 9 g, 5 weeks) or placebo. Participants recorded ESS scores and VAS for sleep quality and refreshing nature of sleep (1-100; 1=poor quality/unrefreshing sleep; 100=good quality/refreshing sleep) using electronic diaries. P-values were calculated using a mixed-effects model for repeated measures in the modified intent-to-treat (mITT) population (ie, participants receiving ≥1 dose of study drug having ≥1 efficacy assessment at week 3). Results In the mITT population (n=190; ON-SXB, n=97; placebo, n=93), baseline ESS scores were 16.6 and 17.5 with ON-SXB and placebo, respectively. At week 2, ESS score was significantly improved with ON-SXB vs placebo (P<0.02) with numerical improvement seen at week 1. At baseline, sleep quality was 53.8 and 55.9 on VAS in the ON-SXB and placebo groups, respectively, and baseline refreshing nature of sleep was 46.5 and 49.9. At weeks 1 and 2, sleep quality (P<0.01; P<0.001) and refreshing nature of sleep (P<0.05; P=0.001) were significantly improved for ON-SXB vs placebo. Conclusion Improvement in daytime sleepiness, sleep quality, and refreshing nature of sleep occurred with ON-SXB beginning the first week of treatment. Some patients may experience early narcolepsy symptom relief with ON-SXB. Support (If Any) Avadel Pharmaceuticals

0207 Mothers’ Adverse Childhood Experiences and Protective Factors are Associated with Rest-activity Rhythms in their Children

Abstract Introduction Mothers’ history of adverse childhood experiences (ACEs; e.g. maltreatment, household dysfunction) are associated with poor health outcomes in their children, but mechanisms underlying this intergenerational transmission are poorly understood. Given links between circadian rhythm and the stress-response system, we test the hypothesis that maternal ACEs influence child health through disrupted rest-activity rhythm (RAR) in the mother and child. We also explore whether mothers’ benevolent childhood experiences (BCEs) are protective against disrupted RAR. Methods We conducted a cross-sectional pilot study of maternal-child dyads with preschool-age children. Mothers reported history of childhood adversity (ACEs Scale, Childhood Trauma Questionnaire) and protective factors (BCE Scale). Dyads wore wrist actigraphs for 8-10 days and mothers completed daily electronic diaries. Nonparametric measures of RAR (e.g. interdaily stability [IS], intradaily variability [IV]) were calculated. We used linear regression to examine associations between mothers’ childhood history and maternal and child RAR measures, controlling for household size and maternal employment. Results Maternal-child dyads (N=20) identified as white (75%), Black (15%), and Hispanic/Latina (10%). Mean child age was 4.2 years (40% female). Average household size was 4.5 ±.1.1 and 65% of mothers were employed. Forty-two percent of mothers reported 1-2 ACEs and 25% reported 3 or more ACEs. Maternal childhood history was not associated with mothers’ RAR. However, maternal ACEs and CTQ total score were associated with decreased child IS (ACEs: β= -0.47, SE=0.01, p=.02; CTQ total: β= -0.53, SE=.01, p=.001) and increased child IV (ACEs: β=0.29, SE=.01, p=.051; CTQ total: β=0.38, SE+.00, p=.03). CTQ subscales revealed maternal childhood physical abuse (β= -0.54, SE=.01, p<.0001), emotional abuse (β= -0.42, SE=.00, p=.002), and sexual abuse (β= -.73, SE=.00, p<.0001) were associated with decreased child IS, while maternal childhood emotional neglect was associated with increased child IV (β= 0.39, SE=.01, p=.04). Maternal BCEs were associated with decreased child IV (β= -0.44, SE=.01, p=.03). Conclusion Maternal ACE history may influence child health through effects on children’s circadian rhythm (i.e. decreased synchronization, increased fragmentation), while maternal BCEs may protect against rhythm fragmentation. Additional research is needed to support these novel preliminary findings. Support (If Any) National Institute of Nursing Research (K99NR018876) and American Nurses Foundation.

0611 Intraindividual Variability in Subjective Sleep and Average Fatigue in Parents of Children on the Autism Spectrum

Abstract Introduction Fatigue is related to various adverse health outcomes. Mean levels of some common sleep variables, such as total sleep time (TST), sleep onset latency (SOL), and wake after sleep onset (WASO), have been associated with fatigue. However, intraindividual variability (IIV) of sleep parameters might play an independent role in sleep’s relationship with fatigue. Understanding fatigue is particularly important for parents of children with autism spectrum disorder (ASD) given fatigue's negative associations with positive parenting and implementation of child interventions. This preliminary study examined linear associations between subjective sleep IIV and mean fatigue levels in parents of children on the autism spectrum. Methods The sample included 66 parents who expressed interest in a behavioral treatment sleep study for their school-aged children diagnosed with ASD (6-12 years old; NCT04545606). All parents (Mage=37.03, SD=6.53; 91% female) completed daily electronic diaries over a two-week baseline period. Daily fatigue rating was collected using a visual analog scale (0-100) and averaged within individuals. Within-individual standard deviations of subjective TST, SOL, and WASO were calculated to estimate IIV. Data were analyzed in R (v4.1.2) using multiple linear regression models controlling for participant age, gender, and individual sleep parameter means. Results Bivariate correlations between sleep variable IIV and average fatigue indicated a positive association between TST variability and average fatigue, r(64)=0.33, p<0.01. Multiple regression analyses showed that greater IIV of TST was associated with higher average fatigue (β=0.14, 95%CI [0.01, 0.27], sr2=0.06, p=0.041). No significant associations were found between average fatigue level and IIV of WASO or SOL. Conclusion Results suggest that greater TST variability may be one factor independently contributing to higher fatigue levels in parents of children on the autism spectrum, which warrants further examination of sleep variability in this population. Future research could explore IIV of additional sleep parameters, fatigue IIV as an outcome, alternative methods of sleep measurement, and study designs that address causation. Increased insight into these connections might inform the importance of considering sleep interventions for both children and parents, and potential subsequent treatment benefits. Support (If Any) MU Research Board Grant (McCrae, PI); Department of Defense Autism Research Program (McCrae, PI; W81XWH2010399).

Development and content validation of the Symptoms Evolution of COVID-19: a patient-reported electronic daily diary in clinical and real-world studies

BackgroundAt the onset of the COVID-19 pandemic, there was limited understanding of symptom experience and disease progression. We developed and validated a fit-for-purpose disease-specific instrument to assess symptoms in patients with COVID-19 to inform endpoints in an interventional trial for non-hospitalized patients.MethodsThe initial drafting of the 23-item Symptoms Evolution of COVID-19 (SE-C19) Instrument was developed based on the Centers for Disease Control and Prevention symptom list and available published literature specific to patients with COVID-19 as of Spring 2020. The measurement principles outlined in the Food and Drug Administration (FDA) Patient-Reported Outcomes (PRO) guidance and the FDA's series of four methodological Patient-Focused Drug Development guidance documents were also considered. Following initial development, semi-structured qualitative interviews were conducted with a purposive sample of 30 non-hospitalized COVID-19 patients. Interviews involved two stages: (1) concept elicitation, to obtain information about the symptoms experienced as a result of COVID-19 in the patients’ own words, and (2) cognitive debriefing, for patients to describe their understanding of the SE-C19 instructions, specific symptoms, response options, and recall period to ensure the content of the SE-C19 is relevant and comprehensive. Five clinicians treating COVID-19 outpatients were also interviewed to obtain their insights on symptoms experienced by patients and provide input on the SE-C19.ResultsPatients reported no issues regarding the relevance or appropriateness of the SE-C19 instructions, including the 24-h recall period. The comprehensiveness of the SE-C19 was confirmed against the conceptualization of the patient experience of symptoms developed in the qualitative research. Minor conceptual gaps were revealed to capture nuances in the experience of nasal and gustatory symptoms and systemic manifestations of sickness. Almost all items were endorsed by patients as being appropriate, well understood, and easy to respond to. The clinicians largely approved all items, response options, and recall period.ConclusionsThe qualitative research provided supportive evidence of the content validity of the SE-C19 to assess the symptoms of outpatients with COVID-19, and its use in clinical trials to evaluate the benefit of treatment. Minor changes may be considered to improve conceptual clarity and ease of responding.

Time to go green?

Time to go green?

Five reasons to cry—FRC: a taxonomy for common antecedents of emotional crying

Human beings are probably the only creatures with a capacity to shed emotional tears. While prior work has mostly used data-driven approaches to identify situational antecedents of adult crying, we present a theory-based taxonomy. Assuming that crying is preceded by the frustration or satisfaction of psychological needs, we postulate that the most common antecedents of crying can be organized into five categories—that is, the Five Reasons to Cry (FRC): loneliness, impotence, overload, harmony, and media. Testing our assumptions in a retrospective study (N = 720, pre-registered) and a thirty-day electronic diary study (N = 91) showed that (i) crying episodes could be reliably assigned to the FRC, (ii) the theorized relations to frustrated/satisfied psychological needs emerged, and (iii) the categories were systematically related to subjective well-being, indicating their criterion validity. In sum, this research provides a valid taxonomy of common situational antecedents of adult emotional crying.

Adherence among a cohort taking progestin-only pills prescribed by a healthcare provider: Results of the BENCHMARK study

ObjectivesTo measure adherence over six months of progestin-only pill (POP) use. Study DesignProspective observational cohort study measuring adherence to daily dosing and timing of dose in patients prescribed a POP, with up to six months of follow-up, conducted from January to October 2020. A pharmacy benefit manager identified potential participants with a newly prescribed POP and extended an invitation to participate. We enrolled qualified respondents by telephone, trained them to use an electronic diary to report daily whether they had taken their POP and at what time. We followed participants for up to six months. We calculated adherence to daily pill taking as the proportion of evaluable days in which a participant took a POP, and the proportion of participants reporting ≥85% adherence. We calculated adherence to same time each day as the proportion of doses taken no later than three hours after the previous dose time of day. ResultsThe user population comprised 199 participants, 154 (77.4%) of whom completed six months of follow-up. The majority (n = 170, 85.4%) were taking norethindrone. Norethindrone users reported POP intake on 22,327 (96.4%) of 23,156 evaluable days, with 155 (91.2%) participants reporting ≥85% adherence; less than half (n = 73, 42.9%) reported 100% adherence. Participants reported adherence to same time each day on 21,698 of 22,157 (97.9%) evaluable days. ConclusionsAmong participants taking a prescribed POP, participants demonstrated high adherence for daily pill taking and the same time of day, though the majority were not 100% adherent. ImplicationsThis study reports data specific to adherence among those taking a progestin-only pill (POP) in the prescription setting. Clinicians who counsel patients about POP use should be aware that majority of patients were not 100% adherent, although most report ≥85% adherence.

Workplace contact patterns in England during the COVID-19 pandemic: Analysis of the Virus Watch prospective cohort study.

SummaryBackgroundWorkplaces are an important potential source of SARS-CoV-2 exposure; however, investigation into workplace contact patterns is lacking. This study aimed to investigate how workplace attendance and features of contact varied between occupations across the COVID-19 pandemic in England.MethodsData were obtained from electronic contact diaries (November 2020-November 2021) submitted by employed/self-employed prospective cohort study participants (n=4,616). We used mixed models to investigate the effects of occupation and time for: workplace attendance, number of people sharing workspace, time spent sharing workspace, number of close contacts, and usage of face coverings.FindingsWorkplace attendance and contact patterns varied across occupations and time. The predicted probability of intense space sharing during the day was highest for healthcare (78% [95% CI: 75–81%]) and education workers (64% [59%–69%]), who also had the highest probabilities for larger numbers of close contacts (36% [32%–40%] and 38% [33%–43%] respectively). Education workers also demonstrated relatively low predicted probability (51% [44%–57%]) of wearing a face covering during close contact. Across all occupational groups, workspace sharing and close contact increased and usage of face coverings decreased during phases of less stringent restrictions.InterpretationMajor variations in workplace contact patterns and mask use likely contribute to differential COVID-19 risk. Patterns of variation by occupation and restriction phase may inform interventions for future waves of COVID-19 or other respiratory epidemics. Across occupations, increasing workplace contact and reduced face covering usage is concerning given ongoing high levels of community transmission and emergence of variants.FundingMedical Research Council; HM Government; Wellcome Trust

Leveraging electronic patient diaries in SUDEP risk evaluation

ObjectiveOur aim was to describe the risk factors known to be related to sudden unexpected death in epilepsy (SUDEP) that can be extracted from patients that utilizes an online seizure diary tool (SeizureTracker™). MethodWe conducted a descriptive analysis of SeizureTracker™ users across factors relevant to SUDEP risk. We also compared our app-using cohort to published SUDEP case-control studies. ResultsWe report across seven risk factors from 30,813 users of SeizureTracker™ who had a median length of time using the app of 5.69 years (range from 1 month to 15 years). We found that they are at greater risk for SUDEP than groups from published studies (p < .00001) based on the risk factor of generalized tonic-clonic seizures. SignificanceWe demonstrated that the population using the SeizureTracker™ tool can be a valuable population for expanding investigation of SUDEP risk factors and is a first step towards establishing a large sample with a method to ascertain data prospectively that might be critical to developing a SUDEP risk algorithm.

Development of a text message-based headache diary in adolescents and children.

International guidelines recommend diaries in migraine trials for prospective collection of headache symptoms. Studies in other patient populations suggest higher adherence with electronic diaries instead of pen-and-paper. This study examines the feasibility of a text message-based (texting) diary for children and adolescents with headache. This is a secondary analysis of data from a study validating a pediatric scale of treatment expectancy. We developed a Health Insurance Portability and Accountability Act-compliant texting diary collecting headache characteristics, medication use, and disability with 3-5 core daily questions for 4 or 12 weeks depending on headache treatment. Adherence was incentivized. 93 participants consented to the expectancy study. Five participants opted for a paper diary for follow-up. 88 participants chose the texting diary with 28 4-week and 60 12-week participants. Five participants did not complete the enrollment visit. Of those remaining 83, 89% of 4-week and 93% of 12-week participants responded on at least 80% of days. On average, participants fully completed 88% (4-week cohort) and 90% (12-week) of diary entries. Text messages are a promising method for collecting patient-reported data. Adherence was similar to that reported for paper diaries in other pediatric migraine trials, but time-stamped entries ensure real-time data collection.

Migraine history and response to lasmiditan across racial and ethnic groups

Objective The robust enrollment in SPARTAN and SAMURAI provided the opportunity to present post-hoc descriptive details on migraine disease characteristics and treatment outcomes after treatment with lasmiditan, a selective serotonin (5-HT1F) receptor agonist, in racial and ethnic subgroups. Methods Descriptive data from racial (White [W](n = 3471) and Black or African American [AA](n = 792)) and ethnic (Hispanic or Latinx [HL](n = 775) and Non-Hispanic or Latinx [Non-HL](n = 3637)) populations are presented on pooled data from two double-blind, placebo-controlled, randomized Phase 3 studies (SAMURAI [NCT02439320] and SPARTAN [NCT2605174]). Patients were treated with lasmiditan (50 (SPARTAN only), 100, or 200 mg) or placebo for a single migraine attack of moderate-to-severe intensity. Efficacy data were recorded in an electronic diary at baseline, 30, 60, 90, and 120 min. Safety was evaluated and reported by occurrences of adverse events. Results Clinical characteristics were generally similar across populations. W participants had longer migraine history than AA participants, and Non-HL participants had more migraine disability than HL participants. In the lasmiditan single-attack studies, AA participants waited longer than W participants to take study drug. A higher proportion of HL participants rated baseline migraine severity as severe compared to Non-HL participants. Response to lasmiditan was similar across racial and ethnic groups, including pain response, freedom from most bothersome symptom and migraine-related disability, and safety and tolerability. Across multiple outcomes, AA and HL participants tended to report more positive outcomes. Conclusions There were few differences in demographic and clinical characteristics across racial and ethnic groups. Similar lasmiditan efficacy and safety outcomes were observed in AA versus W participants, and in HL versus Non-HL participants. Small observed differences may be driven by a tendency toward a more positive response observed across all treatment groups by AA and HL participants.

A real-world, observational study of erenumab for migraine prevention in Canadian patients.

ObjectivesTo assess real‐world effectiveness, safety, and usage of erenumab in Canadian patients with episodic and chronic migraine with prior ineffective prophylactic treatments.BackgroundIn randomized controlled trials, erenumab demonstrated efficacy for migraine prevention in patients with ≤4 prior ineffective prophylactic migraine therapies. The “Migraine prevention with AimoviG: Informative Canadian real‐world study” (MAGIC) assessed real‐world effectiveness of erenumab in Canadian patients with migraine.MethodsMAGIC was a prospective open‐label, observational study conducted in Canadian patients with chronic migraine (CM) and episodic migraine (EM) with two to six categories of prior ineffective prophylactic therapies. Participants were administered 70 mg or 140 mg erenumab monthly based on physician’s assessment. Migraine attacks were self‐assessed using an electronic diary and patient‐reported outcome questionnaires. The primary outcome was the proportion of subjects achieving ≥50% reduction in monthly migraine days (MMD) after the 3‐month treatment period.ResultsAmong the 95 participants who mostly experienced two (54.7%) or three (32.6%) prior categories of ineffective prophylactic therapies and who initiated erenumab, treatment was generally safe and well tolerated; 89/95 (93.7%) participants initiated treatment with 140 mg erenumab. At week 12, 32/95 (33.7%) participants including 17/64 (26.6%) CM and 15/32 (48.4%) EM achieved ≥50% reduction in MMD while 30/86 (34.9%) participants including 19/55 (34.5%) CM and 11/31 (35.5%) EM achieved ≥50% reduction in MMD at week 24. Through patient‐reported outcome questionnaires, 62/95 (65.3%) and 45/86 (52.3%) participants reported improvement of their condition at weeks 12 and 24, respectively. Physicians observed improvement in the condition of 78/95 (82.1%) and 67/86 (77.9%) participants at weeks 12 and 24, respectively.ConclusionOne‐third of patients with EM and CM achieved ≥50% MMD reduction after 3 months of erenumab treatment. This study provides real‐world evidence of erenumab effectiveness, safety, and usage for migraine prevention in adult Canadian patients with multiple prior ineffective prophylactic treatments.

A phase II, double blind, placebo-controlled, randomized evaluation of the safety and efficacy of tafenoquine in patients with mild-moderate COVID-19 disease

The safety and efficacy of tafenoquine administered as a 200 mg dose once per day on days 1, 2, 3, and 10 was evaluated over a 28-day period in mild-moderate COVID-19 patients. The primary endpoint was Day 14 clinical recovery from COVID-19 symptoms, defined as cough mild or absent, respiratory rate < 24 bpm, and no shortness of breath or fever. Following a successful futility analysis after n = 86 patients out of a target n = 275 were randomized, the study was terminated and unblinded early to facilitate planning for confirmatory studies. The proportion of patients not recovered on Day 14 was numerically decreased by 27% in the ITT population [8/45 v 10/42 not recovered in the tafenoquine and placebo arms, P = 0.60] and 47% in the PP population [5/42 v 9/41, P = 0.25]. Amongst individuals who recorded responses in an electronic diary at Day 28, all tafenoquine patients were recovered, whereas up to 12% of placebo patients exhibited lingering dyspnea. Time to clinical recovery from COVID-19 symptoms was accelerated in the tafenoquine arm by about 2-2.5 days. There were two COVID-19 related hospitalizations in the placebo arm and one in the tafenoquine arm. Mild, drug related adverse events occurred in 8.4% of individuals in the tafenoquine arm [v 2.4% in the placebo]. Although this trial was underpowered for the primary endpoint due to its early termination, the data are suggestive of a therapeutic benefit associated with tafenoquine administration in outpatients with mild to moderate COVID-19 disease, and larger studies are planned.

Percutaneous Tibial Nerve Stimulation vs Sham Stimulation for Fecal Incontinence in Women: NeurOmodulaTion for Accidental Bowel Leakage Randomized Clinical Trial.

To determine whether percutaneous tibial nerve stimulation (PTNS) is superior to sham stimulation for the treatment of fecal incontinence (FI) in women refractory to first-line treatments. Women aged 18 years or older with ≥3 months of moderate-to-severe FI that persisted after a 4-week run-in phase were randomized 2:1 (PTNS:sham stimulation) to 12 weekly 30-minute sessions in this multicenter, single-masked, controlled superiority trial. The primary outcome was change from baseline FI severity measured by St. Mark score after 12 weeks of treatment (range 0-24; minimal important difference, 3-5 points). The secondary outcomes included electronic bowel diary events and quality of life. The groups were compared using an adjusted general linear mixed model. Of 199 women who entered the run-in period, 166 (of 170 eligible) were randomized, (111 in PTNS group and 55 in sham group); the mean (SD) age was 63.6 (11.6) years; baseline St. Mark score was 17.4 (2.7); and recording was 6.6 (5.5) FI episodes per week. There was no difference in improvement from baseline in St. Mark scores in the PTNS group when compared with the sham group (-5.3 vs -3.9 points, adjusted difference [95% confidence interval] -1.3 [-2.8 to 0.2]). The groups did not differ in reduction in weekly FI episodes (-2.1 vs -1.9 episodes, adjusted difference [95% confidence interval] -0.26 [-1.85 to 1.33]). Condition-specific quality of life measures did not indicate a benefit of PTNS over sham stimulation. Serious adverse events occurred in 4% of each group. Although symptom reduction after 12 weeks of PTNS met a threshold of clinical importance, it did not differ from sham stimulation. These data do not support the use of PTNS as conducted for the treatment of FI in women.

Type and intensity distribution of structured and incidental lifestyle physical activity of students and office workers: a retrospective content analysis

BackgroundPhysical activity (PA) guidelines acknowledge the health benefits of regular moderate-to-vigorous physical activity (MVPA) regardless of bout duration. However, little knowledge exists concerning the type and intensity distribution of structured and incidental lifestyle PA of students and office workers. The present study aimed to i) assess the duration and distribution of intensity of MVPAs during waking hours ≥50% of heart rate reserve (HRR), ii) to identify the type of PA through diary assessment, iii) to assign these activities into structured and lifestyle incidental PA, and iv) to compare this information between students and office workers.MethodsTwenty-three healthy participants (11 students, 12 office workers) recorded heart rate (HR) with a wrist-worn HR monitor (Polar M600) and filled out a PA diary throughout seven consecutive days (i.e. ≥ 8 waking h/day). Relative HR zones were calculated, and PA diary information was coded using the Compendium of PA. We matched HR data with the reported PA and identified PA bouts during waking time ≥ 50% HRR concerning duration, HRR zone, type of PA, and assigned each activity to incidental and structured PA. Descriptive measures for time spend in different HRR zones and differences between students and office workers were calculated.ResultsIn total, we analyzed 276.894 s (76 h 54 min 54 s) of waking time in HRR zones ≥50% and identified 169 different types of PA. The participants spend 31.9 ± 27.1 min/day or 3.9 ± 3.2% of their waking time in zones of ≥50% HRR with no difference between students and office workers (p > 0.01). The proportion of assigned incidental lifestyle PA was 76.9 ± 22.5%.ConclusionsThe present study provides initial insights regarding the type, amount, and distribution of intensity of structured and incidental lifestyle PA ≥ 50% HRR. Findings show a substantial amount of incidental lifestyle PA during waking hours and display the importance of promoting a physically active lifestyle. Future research could employ ambulatory assessments with integrated electronic diaries to detect information on the type and context of MVPA during the day.

Azithromycin and high-dose vitamin D for treatment and prevention of asthma-like episodes in hospitalised preschool children: study protocol for a combined double-blind randomised controlled trial

IntroductionPrevious randomised controlled trials (RCTs) suggest antibiotics for treating episodes of asthma-like symptoms in preschool children. Further, high-dose vitamin D supplementation has been shown to reduce the rate of asthma...

Usability evaluation of the Computer-Based Health Evaluation System (CHES) eDiary for patients with faecal incontinence: a pilot study

BackgroundFaecal incontinence (FI) is prevalent in 15–20% of elderly individuals and is frequently monitored in clinical trials and practice. Bowel diaries are the most common way to document FI, but, in clinical practice, are mainly used as paper-based versions. Electronic diaries (eDiaries) offer many potential benefits over paper-based diaries. The aim of this study was to develop and test an eDiary to document FI.MethodsWe migrated a paper FI diary to an eDiary app based on the Computer-based Health Evaluation System (CHES). To assess usability, we conducted functionality and usability tests at two time points in a sample of patients with FI. In the first assessment, the eDiary functionalities were tested, patients completed the System Usability Scale (SUS, range 0–100) and compared the paper diary with the eDiary. We set a threshold for minimum acceptable average usability at 70 points. Patients were then instructed to use the eDiary for 2 days at home and contacted to report on their usage and completed the SUS a second time.ResultsWe recruited a sample of N = 14 patients to use the eDiary. All patients were able to use all functionalities of the eDiary and only a few patients with lower technological literacy or access to devices (n = 3) needed initial assistance. The mean usability rating given at the first time point was high with 88 points (SD 18, 95% CI 78.2–96.8) and most patients (n = 10) reported they would prefer the eDiary over the paper-based version. Nine patients (n = 9) participated in the follow-up assessment and the mean SUS rating at the second time point was 97 points (SD 7, 95% CI 92.8–100).ConclusionThe eDiary showed excellent usability scores for the assessment of FI at both assessments. Generally, patients preferred the eDiary over the paper-based version. We recommend the eDiary for usage with patients who own and use a smartphone and discuss potential solutions for patients with lower technological literacy or access.

Reduction in migraine-associated burden after eptinezumab treatment in patients with chronic migraine.

ObjectiveTo examine changes in the occurrence, severity, and symptoms of headache episodes in patients with chronic migraine following eptinezumab treatment.MethodsPROMISE-2 was a double-blind, placebo-controlled, parallel-group trial that randomized adults with chronic migraine to eptinezumab 100 mg, 300 mg, or placebo IV every 12 weeks for up to 24 weeks (2 infusions). Headache episodes (migraine and non-migraine) and their characteristics were reported in daily electronic diaries during the 28-day baseline and throughout the 24-week treatment period.ResultsA total of 1072 patients were included in this post hoc analysis. Mean monthly headache days decreased by 8.9 (100 mg) and 9.7 (300 mg) compared to a 7.3 decrease in placebo over the first 4-week interval post initial dose and reductions were maintained throughout the 24-week treatment period. Mean monthly headache episodes also decreased by 8.4 (100 mg) and 9.0 (300 mg) compared to a decrease of 7.1 with placebo. The proportion of headache episodes that were migraine attacks decreased by 11.2% (100 mg), 12.4% (300 mg), and 3.9% (placebo), and among remaining headaches decreases in severe pain, nausea, phonophobia, photophobia, and physical activity limitations were numerically greater than placebo.ConclusionsPatients with chronic migraine treated with eptinezumab decreased the monthly severity and frequency of headache days and episodes more than placebo. Beyond decreased headache frequency, patients treated with eptinezumab reported a reduction in the percent of remaining headache episodes that were migraine attacks, as well as a decrease in burdensome symptoms of headache episodes, indicating additional decreased headache severity after eptinezumab treatment.Trial registration: ClinicalTrials.gov Identifier: NCT02974153; registered November 23, 2016.

A Micro-Longitudinal Study of Naps, Sleep Disturbance, and Headache Severity in Women with Chronic Migraine

ABSTRACT Objective To examine the relationship between headaches, naps, and nocturnal sleep in women with chronic migraine (CM) using micro-longitudinal data from diaries and actigraphy. Methods 20 women with CM and 20 age and sex-matched healthy controls (HC) completed self-report questionnaires, electronic diaries, and wrist actigraphy over a 4-week period. Between-group comparisons were conducted with naps (frequency and duration) as the primary variable of interest. Within-group analyses were conducted on the CM group using hierarchical linear mixed models to examine the temporal relationships between headache severity, sleep behaviors, and sleep parameters. The primary variables of interest were naps (number and duration) and nocturnal sleep efficiency (diary and actigraphy). Results The CM group reported significantly more days with naps (25.85%) compared to the HC group (9.03%) during the study period (p = .0025). Within-group analyses in CM revealed that greater headache severity was associated with longer nap duration (p = .0037) and longer nap duration was associated with lower sleep efficiency measured using diaries (p = .0014) and actigraphy (p < .0001). Conclusions Napping is more frequent in CM than HC and nap duration in CM is associated with headache severity and nocturnal sleep disturbance. These findings provide initial support for the hypothesis that daytime napping is a behavioral coping strategy used in CM that could contribute to insomnia.

Improvement in fatigue and sleep measures with the dual orexin receptor antagonist lemborexant in adults with insomnia disorder

ABSTRACT Objective Fatigue is a common symptom in patients with insomnia. This analysis evaluated whether treatment of nighttime symptoms of insomnia with a dual orexin receptor antagonist, lemborexant, might also reduce fatigue. Methods Analyses were conducted of two phase 3 studies of subjects with insomnia disorder. Subjects received placebo, lemborexant 5 mg, or lemborexant 10 mg in the 12-month (6 months placebo-controlled) Study E2006-G000-303 (Study 303: SUNRISE-2) of adults (N = 949; full analysis set [FAS]), and the 1-month, placebo- and active-controlled Study E2006-G000-304 (Study 304; SUNRISE-1) of older adults (females ≥55 years, males ≥65 years) (N = 1006; FAS). Fatigue was assessed using the Fatigue Severity Scale (FSS). Patient-reported sleep onset and maintenance endpoints were analyzed using data from electronic sleep diaries. Results Lemborexant significantly reduced subject-reported fatigue versus placebo over a 6-month treatment period (FSS total score least-squares mean treatment difference of −2.50 for 5 mg and −2.56 for 10 mg of lemborexant; p < 0.05 for both). This reduction was sustained over 12 months of lemborexant in both the overall population and in subjects with clinically meaningful fatigue (FSS total score ≥36) at baseline. Improvements in fatigue over time positively correlated with improvements in sleep onset and maintenance parameters. Improvements in sleep quality were evident as early as 1 week after lemborexant treatment, whereas longer-term treatment (>1 month) may be needed for improvements in insomnia-related fatigue. Conclusions In addition to improving sleep onset and sleep maintenance in subjects with insomnia disorder, lemborexant provides further benefit by reducing daytime fatigue. Clinical trial registration https://clinicaltrials.gov/ct2/show/NCT02952820 and https://clinicaltrials.gov/ct2/show/NCT02783729 Abbreviations DSM-5 = Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition; FSS = Fatigue Severity Scale; ICSD-3 = International Classification of Sleep Disorders, Third Edition; LSM = least squares mean; sSE = subjective sleep efficiency; sSOL = subjective sleep onset latency; sTST = subjective total sleep time; sWASO = subjective sleep after wake onset.