Electronic Diary Research Articles

Delayed Recovery After Exercise-Induced Pain in People with Chronic Widespread Muscle Pain Related to Cortical Connectivity

Background/Objectives: There is a subset of patients with pain who become worse after exercise. To explore this, we examined the responses of people with chronic primary pain to a standardized high intensity exercise protocol used to induce delayed onset muscle soreness (DOMS). Methods: Ten participants with a diagnosis of chronic widespread muscle pain (CWMP) were matched by age and reported gender to ten participants without muscle pain (i.e., no pain (NP)). Participants completed a standardized DOMS protocol. Pain intensity in the arm at rest and with movement was assessed using daily electronic diaries. Peak pain, the timing of peak pain, and the time to recovery were compared between groups. Associations of pain variables with the functional connectivity of the sensorimotor (SMN), cerebellum, frontoparietal control (FPN), and default mode network (DMN) both within network nodes and the rest of the brain was assessed. Results: Significant differences in peak pain, the time to peak pain, and the time to recovery were noted between groups for both pain at rest and pain with movement after controlling for catastrophizing and pain resilience. Connectivity across the SMN, FPN, and DMN was associated with all pain-related variables. Significant group differences were identified between groups. Conclusions: A standardized muscle “injury” protocol resulted in more pain, a longer time to peak pain, and a longer time to resolve pain in the patient group compared to the NP group. These differences were associated with differences in connectivity across brain regions related to sensorimotor integration and appraisal. These findings provide preliminary evidence of the dysregulation of responses to muscle (micro)trauma in people with chronic pain.

Objective detection of wheeze at home by parents through a digital device: usage patterns and relationship with SABA administration.

Wheezing is an important indicator of exacerbated respiratory symptoms in early childhood and must be monitored to regulate pharmacological therapy. However, parents' subjective perception of wheezing in their children is not always precise. We investigated the objective identification of children's wheezing by parents using a digital wheeze detector (WheezeScanTM, OMRON Healthcare Co. Ltd), its longitudinal usage patterns, and its relationship with SABA administration. We conducted a secondary nested analysis of data from the intervention arm of a multi-center randomized controlled trial completed in 2021-2022 in Berlin (Germany), London (United Kingdom), and Istanbul (Turkey). Children aged 4 to 84 months with doctor's diagnosed wheezing (GINA step 1 or 2) were included. Using an electronic diary (Wheeze-MonitorTM, TPS), parents monitored and recorded for 120 days at home the presence or absence of their child's wheezing, detected both, with WheezeScanTM ("objective" wheezing), and subjective ("perceived" wheezing). Parents also recorded the child's symptoms, medication intake, and family quality of life. Questionnaires regarding symptom control, quality of life, and parental self-efficacy were answered at baseline and after 90 and 120 days. Eighty-one/87 families completed the intervention arm of the study. WheezeScanTM was on average used 0.7 (SD 0.6) times a day, with each patient reporting a positive, negative, or "error" outcome on average in 57%, 39%, and 5% of measurements, respectively. The use of WheezeScanTM declined slightly during the first 90 days of monitoring and steeply thereafter. Repeated usage of WheezeScanTM in the same day was more frequent after a "wheeze" (HR 1.5, 95% CI 1.37-1.65, p < 0.001) and an "error" (HR 2.01, 95% CI 1.70-2.38, p < 0.001) result, compared to a "no wheeze" outcome. The average per-patient daily agreement between "objective" and "perceived" wheezing/non-wheezing was 75% at the start of the monitoring period and only weakly persisted as time passed (Spearman's rho=0.09). The frequency of short-acting beta-2-agonists (SABA) administration was lower in days with closely interspaced consecutive device uses during which the patient's status was perceived as "never wheeze" (32/455, 7%) than in those perceived as "persistent wheeze" (53/119, 44%; OR 36.6, 95% CI [14.3, 94.1]). Daily use of a digital WheezeScanTM at home allows parents to detect their child's unperceived wheezing and discloses to caregivers the longitudinal patterns of a child's wheezing disorder. Digital monitoring of wheezing also highlights poor adherence to guidelines in SABA administration for wheezing children, with under-treatment being much more frequent than over-treatment. This pioneering study opens new perspectives for further investigation of digital wheeze detectors in the early diagnosis and proper self-management of wheezing disorders in childhood.

Home-Based Digital Exercise Training Program to Improve Physical Function of Older Sepsis Survivors: Protocol of the HEAL Sepsis Randomized Clinical Trial.

While sepsis, an exaggerated response to infection, can affect people of all age groups, it is more prevalent in middle-aged and older adults. Older adults suffer worse short-term and long-term outcomes than younger patients. Older sepsis survivors are commonly discharged to long-term acute care facilities, where they often die within 1 year. Those who return home from the hospital lose the momentum of physical function improvement after early inpatient rehabilitation, and often face exacerbation of comorbidities and decline in physical function. Additionally, patients who are discharged home often live at distant locations and are not able to commute to rehabilitation centers due to their poor health status. Therefore, remotely delivered exercise interventions tailored to this population hold promise to improve physical function safely and effectively after sepsis. However, this type of intervention has yet to be tested in this population. This study aims to assess the safety, feasibility, and ease of recruitment and retention of participants for a remotely delivered physical activity intervention for improving physical function in middle-aged and older sepsis survivors. The proposed intervention will be delivered through a digital health platform that comprises a patient-facing mobile app and a 12-week physical activity program specifically designed for middle-aged and older sepsis survivors with poor health status who may face challenges participating in traditional out-patient or community-based exercise interventions. This study is ongoing and plans to enroll 40 sepsis survivors aged 55 years and older who will be randomized to either a remotely delivered exercise intervention group or a control group (electronic health diary). Both groups will use a tablet containing the Health in Motion app (Blue Marble Health). The intervention group will receive a clinician-designed personalized avatar-guided home exercise program and reminders while the control group will self-report daily activities using the in-app health diary feature. This study is the first to use a home-based, remotely monitored 12-week exercise program to improve physical function in sepsis survivors. This study will evaluate the safety, feasibility, and efficacy, providing the necessary knowledge to design and calculate power for future larger trials. This study will provide important information for planning a future randomized clinical trial to test the efficacy of a remotely delivered exercise intervention in this high-risk population. ClinicalTrials.gov NCT05568511; https://clinicaltrials.gov/study/NCT05568511. DERR1-10.2196/60270.

Long-Term (12-Month) Safety and Tolerability of STS101 (Dihydroergotamine Nasal Powder) in the Acute Treatment of Migraine: Data from the Phase 3 Open-Label ASCEND Study.

STS101 is an investigational drug-device combination comprising 5.2 mg dihydroergotamine (DHE) powder (6.0 mg DHE mesylate) in a single-use nasal delivery device for the acute treatment of migraine. The primary objective of the ASCEND trial was to assess long-term safety and tolerability of STS101 in the acute treatment of migraine attacks across 12-18 months, with secondary objectives describing efficacy. ASCEND was an open-label study of STS101 in adults aged 18-65 years with a ≥ 1 year history of migraine with or without aura, with onset before the age of 50 years and 4-12 migraine attacks/month and < 15 headache days/month in each of the 3 months prior to screening. Exclusion criteria included diagnosis of non-migraine headache, history of cerebrovascular disease, and ≥ 2 cardiovascular risk factors. After establishing eligibility, participants could self-administer STS101 5.2 mg as needed for up to 2 doses within 24 h to treat a single migraine attack and up to 12 doses/month. Safety and tolerability evaluations included physical and nasal examinations, vital signs, laboratory tests, and treatment-emergent adverse event (TEAE) assessments. Participants used an electronic diary to record exploratory efficacy parameters, including intensity of headache pain and associated migraine symptoms (photophobia, phonophobia, and nausea). Participant impression questions were asked at months 3, 6, and 12. Of the 6610 migraine attacks treated with a total of 8234 STS101 doses in 344 participants, 945/6610 (14.3%) were associated with a TEAE. Events were predominantly mild or moderate in nature and rarely led to premature study discontinuation (15/344 [4.4%] participants). Treatment was associated with rapid onset of freedom from pain (36.6%, 67.1%, and 85.5% of treated attacks 2, 4, and 24 h post-dose, respectively), freedom from most bothersome symptoms (54.3%, 79.6%, and 91.3%), and headache relief (66.5%, 89.1%, and 94.3%). Most participants rated treatment results as good or very good and ease of use as easy or very easy at all time points (months 3, 6, and 12) and indicated they were likely or very likely to use STS101 again. The repeated long-term, as-needed use of STS101 was well tolerated, demonstrating a favorable safety profile in the acute treatment of migraine attacks in appropriately indicated adults. Exploratory efficacy evaluations indicated beneficial effects, which warrant further evaluation. ClinicalTrials.gov identification NCT04406649.

Greater lactate accumulation does not alter peripheral concentrations of key appetite-regulating neuropeptides.

The potential mechanisms involved in lactate's role in exercise-induced appetite suppression requires further examination. We used sodium bicarbonate (NaHCO3) supplementation in a double-blind, placebo controlled, randomized crossover design to explore lactate's role on neuropeptide Y (NPY), agouti-related peptide (AgRP), and alpha-melanocyte stimulating hormone (α-MSH) concentrations. Twelve adults (7 males; 24.2±3.4 kg‧m-2; 42.18±8.56 mL‧kg-1‧min-1) completed two identical high-intensity interval training sessions following ingestion of NaHCO3 (BICARB) or sodium chloride (PLACEBO) pre-exercise. Blood lactate, acylated ghrelin, NPY, AgRP, α-MSH, and appetite perceptions were measured pre-exercise, 0-, 30-, 60-, and 90-min post-exercise. Free-living energy intake (electronic food diaries) was measured the day before, of, and after each experimental session. In BICARB, blood lactate was greater post-exercise (p<0.002, d>0.70) though acylated ghrelin was similar (p=0.075, =0.206) at all time-points post-exercise (p>0.034, d<0.22). NPY (p=0.006, >0.509) and AgRP (p<0.001, >0.488) had main effects of time increasing following exercise and returning to baseline, with no differences between sessions (NPY: p=0.0.192, =0.149; AgRP: p=0.422, =0.060). α-MSH had no main effect of time (p=0.573, =0.063) or session (p=0.269, =0.110). Appetite perceptions were similar during BICARB and PLACEBO (p=0.007, d=0.28) increasing in both sessions post-exercise (p<0.088, d>0.57). Energy intake had a main effect of day (p=0.025, =0.825), where the experimental session day was greater than the day before (p=0.010, d=0.59) with no other differences between days (p>0.260, d<0.38). The lower accumulation of lactate than our previous work did not generate exercise-induced appetite suppression as there were no differences in acylated ghrelin, appetite perceptions, or peripheral concentrations of neuropeptides.

Sleep, Well-Being, and Cognition in Medical Interns on a Float or Overnight Call Schedule

Extended work hours and night shifts are essential in health care, but negatively affect physician sleep, well-being, and patient care. Alternative schedules with shorter work hours and/or reduced irregularity might mitigate these issues. To compare sleep, well-being, and cognition between interns working irregular, extended shifts (call schedule), and those working a more regular schedule with restricted hours (float schedule). In this observational longitudinal cohort study, interns in a Singapore-based teaching hospital were studied for 8 weeks from January 2022 to July 2023. Data were analyzed from July 2023 to July 2024. Participants worked either regular approximately 10-hour workdays, interspersed with 24 hour or more overnight calls 4 to 5 times a month, or a float schedule, which included regular approximately 10-hour workdays, and 5 to 7 consecutive approximately 12-hour night shifts every 2 months. Exposure was based on departmental training and operational needs. Sleep was measured with wearable sleep trackers and an electronic diary. Day-to-day well-being and cognitive assessments were collected through a smartphone application. Assessments included the Sleep Regularity Index (SRI; determines the probability of an individual being in the same state [sleep or wake] at any 2 time points 24 hours apart, with 0 indicating highly random sleep patterns and 100 denoting perfect regularity) and Pittsburgh Sleep Quality Inventory (PSQI; scores ranges from 0 to 21, with higher scores indicating poorer sleep; a score greater than 5 suggests significant sleep difficulties). Participants (mean [SD] age, 24.7 [1.1] years; 57 female participants [59.4%]; 41 on call schedule [42.7%]; 55 on float schedule [57.3%]) provided 4808 nights of sleep (84.2%) and 3390 days (59.3%) of well-being and cognition assessments. Participants on a float schedule had higher SRI scores (mean [SD] score, 69.4 [6.16]) and had better quality sleep (PSQI mean [SD] score, 5.4 [2.3]), than participants on call schedules (SRI mean [SD] score, 56.1 [11.3]; t91 = 6.81; mean difference, 13.3; 95% CI, 9.40 to 17.22; P < .001; PSQI mean [SD] score, 6.5 [2.3]; t79 = 2.16; 95% CI, 0.09 to 2.15; P = .03). Overnight call shifts, but not night float shifts, were associated with poorer mood (-13%; β = -6.79; 95% CI, -9.32 to -4.27; P < .001), motivation (-21%; β = -10.09; 95% CI, -12.55 to -7.63; P < .001), and sleepiness ratings (29%; β = 15.96; 95% CI, 13.01 to 18.90; P < .001) and impaired vigilance (21 ms slower; β = 20.68; 95% CI, 15.89 to 25.47; P < .001) compared with regular day shifts. Night shifts with naps were associated with better vigilance (16 ms faster; β = -15.72; 95% CI, -28.27 to -3.17; P = .01) than nights without naps. In this cohort study, 24-hour call schedules were associated with poorer sleep, well-being, and cognition outcomes than float schedules. Naps during night shifts benefited vigilance in both schedules.

S833 How Valuable is an Electronic Stool Diary App in the Management of Chronic Idiopathic Constipation (CIC) When Using the Vibrating Capsule (VC)

S833 How Valuable is an Electronic Stool Diary App in the Management of Chronic Idiopathic Constipation (CIC) When Using the Vibrating Capsule (VC)

14 - Do current electronic bladder diary Apps provide data suited for clinical use? Evaluation using a Validated Framework Analysis.

14 - Do current electronic bladder diary Apps provide data suited for clinical use? Evaluation using a Validated Framework Analysis.

Pro-Ictal EEG Scheduling Improves the Yield of Epilepsy Monitoring: Validating the Use of Multiday Seizure Cycles to Optimize Video-EEG Timing.

A significant challenge of video-electroencephalography (vEEG) in epilepsy diagnosis is timing monitoring sessions to capture epileptiform activity. In this study, we introduce and validate "pro-ictal EEG scheduling", a method to schedule vEEG monitoring to coincide with periods of increased seizure likelihood as a low-risk approach to enhance the diagnostic yield. A database of long-term ambulatory vEEG monitoring sessions (n = 5,038) of adults and children was examined. Data from linked electronic seizure diaries were extracted (minimum 10 self-reported events) to generate cycle-based estimates of seizure risk. In adults, vEEG monitoring sessions coinciding with periods of estimated high-risk were allocated to the high-risk group (n = 305) and compared to remaining studies (baseline: n = 3,586). Test of proportions and risk-ratios (RR) were applied to index differences in proportions and likelihood of capturing outcome measures (abnormal report, confirmed seizure, and diary event) during monitoring. The impact of clinical and demographic factors (age, sex, epilepsy-type, and medication) was also explored. During vEEG monitoring, the high-risk group was significantly more likely to have an abnormal vEEG report (190/305:62% vs 1,790/3,586:50% [%change = 12%], RR = 1.25, 95% confidence interval [CI] = [1.137-1.370], p < 0.001), present with a confirmed seizure (56/305:18% vs 424/3,586:11% [%change = 7%], RR = 1.63, 95% CI = [1.265-2.101], p < 0.001) and report an event (153/305:50% vs 1,267/3,586:35% (%change = 15%), RR = 1.420, 95% CI = [1.259:1.602], p < 0.001). Similar effects were observed across clinical and demographic features. This study provides the first large-scale validation of pro-ictal EEG scheduling in improving the yield of vEEG. This innovative approach offers a pragmatic and low-risk strategy to enhance the diagnostic capabilities of vEEG monitoring, significantly impacting epilepsy management. ANN NEUROL 2024.

Application of ICU electronic diary platform based on co-design concept in Chinese critically ill patients: a mixed methods study protocol.

Critically ill patients are at a heightened risk for post-traumatic stress disorder (PTSD). While the intensive care unit (ICU) diary has been shown to improve the mental health and quality of life of ICU patients, the handwritten version still has some limitations such as a lack of support for multimedia content and writing by remote family members, as well as being time-consuming and labour-intensive. We hypothesise that constructing an ICU electronic diary platform based on a co-design approach and verifying its applicability could alleviate these limitations, making the ICU diary more convenient for users. This sequential exploratory mixed-methods study will consist of four consecutive phases: understanding the ICU diary research content and implementation, developing an ICU electronic diary platform after conducting qualitative interviews with stakeholders, verifying the applicability of the platform and verifying its effectiveness. Ethics approval was obtained from the Biomedical Research Ethics Committee of the Affiliated Hospital of Zunyi Medical University (approval number: KLL-2023-602). The results of this study will be distributed through peer-reviewed journals. Chinese Clinical Trial Register (ChiCTR2400079903).

A Multicenter Prospective Sham-controlled Trial Evaluating a Physiologic Closed-loop Wearable Tibial Neuromodulation System for Overactive Bladder

ObjectiveTo evaluate the effectiveness and safety of a home-based, physiologic closed-loop wearable tibial neuromodulation system in comparison to a sham control for the treatment of Overactive Bladder (OAB). MethodsThis multicenter, prospective, randomized, double-blind, sham-controlled trial included 125 adult subjects with OAB who were randomized 1:1 to receive either active therapy with the Vivally System or sham therapy. Patients were allowed to continue concomitant OAB medications if therapy was stable and the remained on a consistent regimen throughout the study. The primary efficacy endpoint was a responder rate, defined as ≥50% reduction in daily urgency leaks or a ≥30% reduction in daily voids from baseline recorded on an electronic voiding diary. Safety was evaluated through adverse event (AE) reporting and patient satisfaction with the system was recorded. ResultsIn the the modified Intent-to-Treat (mITT) population (n=107) the responder rate was significantly higher in the active therapy arm (83.6%) compared to the sham arm (57.7%; p=0.032). The system demonstrated a favorable safety profile with no serious AE. Patient satisfaction with the device and mobile application was high with 90/92 (97.8%) reporting they were moderately to extremely satisfied and therapy compliance was above 92% for both therapy and sham groups. ConclusionThe Vivally System showed significant improvement in OAB symptoms compared to sham therapy, demonstrating a high responder rate and excellent safety profile. The combination of physiologic closed-loop neuromodulation and a behavior-tracking application may offer an effective and user-friendly option for OAB management.

Daily and Weekly Associations Among Pain Intensity, Self-Reported Activity Limitations, and Objectively Assessed Physical Activity in Youth With Acute Musculoskeletal Pain

Monitoring recovery during acute pain episodes is useful for identifying youth at risk for pain persisting. Subjective and objective measures can assess function postinjury, but associations among these different measures and pain patterns in the acute period are unknown. To fill this gap, we examined associations among self-reported activity limitations, objectively measured physical activity, and pain intensity in 176 youth (age 11–17, 46% male) seeking health care for acute musculoskeletal pain. Participants completed 7-day electronic diaries rating daily pain intensity and activity limitations (Child Activity Limitations Interview [CALI]) while concurrently wearing an Actiwatch to record physical activity. The results revealed youth reported pain on 47.8% of days with an average intensity of 33.4 (0–100). Averaged across the week, between-participant analyses showed greater activity limitations were associated with lower mean (rActive = −.204, rRoutine = −.159, P < .05) and peak activity (rActive = −.291, rRoutine = −.184, P < .05). Same-day correlations between CALI scores and physical activity measures within participants were not significant. Linear mixed-effects models revealed higher daily pain intensity was associated with greater self-reported activity limitations on Routine (β = .23, P < .001) and Active CALI-9 subscales (β = .07, P < .001). Conversely, higher daily pain was associated with higher activity on actigraphy, specifically higher mean activity (β = .46, P < .01), more activity bouts (β = .013, P < .01), more time in light activity (β = .04, P < .01), and less sedentary time (β = −.04, P < .01). Taken together, self-reported activity limitations and objective physical activity represent 2 distinct, yet related, aspects of physical functioning associated with pain. Future work should examine how physical activity and activity limitations change longitudinally and predict pain persistence. PerspectiveThis study examined daily associations between pain intensity, self-reported activity limitations, and objectively assessed physical activity in youth during the acute recovery period following a musculoskeletal injury. Self-reported activity limitations and objective physical activity represent 2 distinct, yet related, aspects of physical functioning that are associated with pain.

Effect of the Implementation of a Multiple-Behavior Self-Monitoring Intervention on Dietary Intake in Type 2 Diabetes: Secondary Data Analysis.

An electronic diary embedded in a mobile device to monitor lifestyle can be as effective as traditional methods. However, the efficacy of self-monitoring multiple behaviors for dietary intake has not been well studied in people with diabetes. This study aimed to compare the effect of using technology-assisted self-monitoring versus paper diaries on changes in dietary intake. This is a secondary analysis of data collected from 39 people with type 2 diabetes as part of a 3-month pilot clinical trial. Changes in energy intake and the contribution of total fat intake and total carbohydrate intake to total calories (%) from baseline to after intervention (3 months) were evaluated. In total, 26 (67%) of the 39 participants preferred mobile diaries over paper diaries. Participants in the mobile diary group showed slightly higher self-monitoring adherence. Linear mixed modeling results indicated a significant overall decrease in total energy intake (P=.005), dietary fat intake (P=.01), and carbohydrate intake (P=.08) from baseline to 3 months. No significant group differences were detected (P>.05). The implementation of a 3-month, multiple-behavior, self-monitoring intervention in Diabetes Self-Management Education programs has resulted in successful reduction in dietary intake (energy, fat, and carbohydrate), whichever self-monitoring method is chosen by participants according to their preferences. Long-term studies are needed to confirm our findings on dietary intake and examine other behavioral and disease outcomes that require monitoring.

Breaking bread: Assessment of household bread waste incidence and behavioural drivers

Bread, the most consumed floury product in the world, is one of the most wasted food products across the food supply chain. Yet, there is a paucity of research examining the magnitude of bread waste and behavioural drivers associated with it at the household level. This study analyses the incidence, behavioural drivers and disposal pathways of bread waste using a sample of 1462 households in Australia and a 7-day electronic diary method. Behavioural drivers related to bread waste were modelled using logistic regression models. The findings suggest that bread rolls, sliced bread and flat bread are the three most wasted bread products in Australian households. Higher grocery shopping frequency, ‘just-in-case’ buying, family households with young children and takeaway meal ordering are associated with higher bread waste. Bread disposal pathway analysis revealed that 55% of bread and bakery products are discarded through general waste bins, highlighting the immense potential of utilising bread waste in industrial processes such as biofuel production. Addressing bread and bakery waste can significantly contribute to achieving the SDG12.3 goal of halving the per capita food waste by 2030.

Самоконтроль уровня глюкозы у пациентов с сахарным диабетом 2-го типа

Self-monitoring of blood glucose has been considered to be a cornerstone of adequate diabetes management for decades. The structured self-monitoring leads to better compensation of carbohydrate metabolism disorders, decreased risk of hypoglycemia, and quality of life improvement in patients with DM. The technologies, as well as the glucose meter convenience and accuracy have improved considerably since the moment these were introduced several decades ago. Modern glucose meters are small and easy to use; these require small amounts of capillary blood and provide measurement results within seconds. Furthermore, glucose meters are more and more often equipped with such features, as connectivity with other devices and/or electronic diaries and instruments for diabetes management. Despite the fact that the measurement accuracy can be close to or equal to the quality level ensured by laboratory biochemical analyzers, some glucose meters continue to fall short of the internationally accepted accuracy standards, such as ISO-15197, the standard of the International Organization for Standardization. Numerous reports from the number of countries, such as Russia, China, India, and Brazil, that are based on the routine practice data suggest that in addition to the problems with the glucose meter accuracy, there are other obstacles to overcome to optimize the use of blood glucose monitoring systems. Nevertheless, the adequate use of blood glucose self-monitoring data is very important for treatment of patients with type 2 diabetes mellitus.

Understanding musculoskeletal disorders in dancers: The role of lumbopelvic muscles and movement competency

ObjectiveTo investigate whether transversus abdominis activation (TrA), hip strength, and movement competency are associated with the incidence of musculoskeletal disorder episodes (MDEs) in dancers when controlling for confounding variables. The secondary objectives were to determine if there were differences between professional and preprofessional dancers for the aforementioned factors, as well as to determine if there were differences in TrA activation and hip strength between the dominant and non-dominant sides. DesignProspective cohort study. Methods118 dancers were recruited. The independent variables were collected at the beginning of the dance season: 1) TrA activation, 2) hip strength, and 3) movement competency. To assess the development of MDEs, a weekly electronic diary was used over a 38-week period. MDEs were compiled for each dancer's whole body and subdivided into total musculoskeletal disorder episodes (all body parts) and lower quadrant musculoskeletal disorder episodes (lower limb and lower back). ResultsLower TrA, as well as higher hip abductor and external rotator strength, were associated with a lower incidence of MDEs. TrA activation (β = 0.260, p = 0.023) and hip external rotator strength (β = −0.537, p = 0.002) could significantly explain 25.4% of the variance of total MDEs, as well as 20.9% of the variance of lower quadrant musculoskeletal disorder episodes (β = 0.272, p = 0.016; β = −0.459, p = 0.011). No significant associations were found between movement competency and MDEs. ConclusionsHigher hip strength could be a protective factor for MDEs among dancers. Further studies are needed to better understand the involvement of the transversus abdominis in MDEs.

Safety of topical sildenafil cream, 3.6% in a randomized, placebo-controlled trial for the treatment of female sexual arousal disorder.

There are currently no Food and Drug Administration-approved treatments for female sexual arousal disorder (FSAD), which is physiologically analogous to male erectile dysfunction. The study sought to test the systemic and local genital safety of topical sildenafil cream, 3.6% (sildenafil cream) among healthy premenopausal women with FSAD and their sexual partners over a 12-week treatment period. This was a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream among healthy premenopausal women with FSAD. Safety was assessed by the frequency and incidence of treatment-emergent adverse events (TEAEs) among participants and their sexual partners. Participants recorded the incidence of TEAEs in a daily eDiary (electronic diary). Sexual partners were contacted within 72hours of each sexual event in which investigational product was used. All participants used placebo cream for 1 month, during a single-blind run-in period, and then if eligible, were randomized 1:1 to sildenafil cream or placebo cream. Participants used their assigned investigational product over a 12-week double-blind dosing period. They attended monthly follow-up visits, in which their eDiary TEAE data were reviewed by the study staff and graded for severity and relationship to study product. The frequency and incidence of TEAEs among participants and their sexual partners. During the 12-week double-blind dosing period, there were 78 TEAEs reported by 29 of 99 sildenafil-assigned participants and 65 TEAEs reported by 28 of 94 placebo-assigned participants (P= .76). All TEAEs were mild or moderate in severity. The most common treatment-related TEAE among active and placebo-assigned participants was application site discomfort. There were no differences in the number of treatment-related TEAEs among sildenafil cream vs placebo cream users (P> .99). Four sildenafil cream participants and 3 placebo cream participants discontinued the study due to TEAEs involving application site discomfort (P> .99). There were 9 TEAEs reported by 7 of 91 sexual partners exposed to sildenafil cream vs 4 TEAEs reported by 4 of 84 sexual partners exposed to placebo cream (P= .54). These data support further clinical development of topical sildenafil cream for the treatment of FSAD. Safety was assessed among participants and their sexual partners after 1357 and 1160 sexual experiences in which sildenafil cream or placebo cream were used, respectively. The phase 2b study was powered for the primary objectives of efficacy, rather than safety. These data demonstrate that topically applied sildenafil cream was safe and well tolerated by exposed users and their sexual partners.

Comparisons and correlations of 1-month recall vs 24-hour recall in patient-reported outcomes of an exploratory, phase 2b, randomized, double-blind, placebo-controlled clinical trial of sildenafil cream, 3.6% for the treatment of female sexual arousal disorder.

Efficacy assessments in clinical trials of treatments for female sexual arousal disorder (FSAD) and other female sexual dysfunction (FSD) diagnoses rely on various patient-reported outcomes (PROs). We sought to compare 1-month recall PRO measures among participants enrolled in a clinical trial who provided these data without (test population) vs with (control population) use of an at-home, 24-hour recall electronic diary (eDiary), capturing similar data. Preplanned subset analysis as performed during a phase 2b, exploratory, randomized, placebo-controlled, double-blind study of sildenafil cream, 3.6% (sildenafil cream) among healthy premenopausal women with FSAD. Preliminary product efficacy was assessed via 1-month recall and 24-hour recall questionnaires. A subset of the participants, the Evaluation of Recall Subset [ERS] provided PROs via the 1-month recall instruments but did not provide data via the 24-hour recall eDiary. Responses to the 1-month recall instruments were compared among ERS (test) vs non-ERS (control) participants. Among the non-ERS population, correlations between 1-month and 24-hour recall endpoints were calculated. There were no significant differences in the study co-primary 1-month recall efficacy endpoints, the Arousal Sensation (AS) domain of the 28-item Sexual Function Questionnaire (SFQ28) and the Female Sexual Distress Scale - Desire, Arousal, Orgasm question 14, among ERS vs non-ERS participants during the initial 1-month no-drug run-in period or the 1-month single-blind placebo run-in period (P values > .47). Scores on these 1-month recall PROs continued to be similar after randomization for sildenafil cream (P values > .30) and placebo cream (P values > .20) assigned ERS and non-ERS participants during the 3-month double-blind dosing period. There were strong correlations between the SFQ28 AS and eDiary AS scores during the no-drug run-in (R= 0.79, P< .01) and the single-blind run-in (R= 0.73 P< .001). During the double-blind dosing period, the SFQ28 AS score continued to be highly correlated with the eDiary AS score among sildenafil cream users (R= 0.83; P< .001) and placebo cream users (R= 0.8; 2 P< .001). There was no evidence that 1-month recall PRO instruments introduce recall bias; assessing arousal sensations with 24-hour vs 1-month PRO instruments is similar and either method could be used to assess efficacy depending on study objectives. This preplanned subset analysis compared efficacy of PROs based on recall duration. While the subset was preplanned, the study was powered to detect significant differences in the primary efficacy objectives, not among this subset analyses. These data will be used in planning future efficacy assessments of sildenafil cream for FSAD. This clinical trial was registered with ClinicalTrials.gov, NCT04948151.

WEB APPLICATION «ELECTRONIC READER’S DIARY» BY AGILE TECHNOLOGY

The article relate to the development of an reader’s electronic diary by AGILE technology. It is needed for reader competency of primary school students. The current students were born in a new information environment. They master information and software faster than adults (for example, gadgets, tablet PC, mobile devices, etc.) The disadvantage is this information environment is reluctance to read. One of the stimulation tools to reading is electronic reader’s diary technology applied in the educational process. The regular reader’s diary is a report about books read. The aim of the reader’s diary is skills reflection and development of the critical analysis skills formation. The project software is designed for primary school students (age 7-10 years). Independent reading skills form at primary school age. It improves cognitive interests of school students, enhances knowledge, and is the formation of a harmoniously developed personality. The electronic reader’s diary stimulates the knowledge interests and consolidates the reading material by AGILE technology and additional interactivity with the school students. The research relates to the architecture of the developed solution, in particular, the issue of the «automated process control system of education system resources» integration. Also, the article contains the map of the developed graphical user interface screen and describing main electronic reader’s diary screens. This research will be intended to boost cognitive and creative activity of students.

Practical Experience with the Use of Electronic Headache Diaries and Video Consultations in Migraine Care from a Longitudinal Cohort Study.

Background: Telemedicine offers a promising solution to enhance the delivery and personalization of headache care. Integrating electronic (e-)tools enables the objective monitoring of migraine. Objectives: This study aims to demonstrate the relevance of e-tools for personalized headache care, assess patient and caregiver compliance and satisfaction, and present their use in enhancing care. Methods: Firstly, a systematic review was performed to validate the diagnostic accuracy of e-diaries for diagnosing migraine. Secondly, we collected e-diary data prospectively from diagnosed adult migraine patients at the Leiden Headache Center. Finally, questionnaires were sent to evaluate satisfaction of patients and health care providers with the Leiden e-headache diary and video consultations. Results: In the systematic review, the Leiden Headache Center's e-diary was the only validated tool. Patients (n = 1,009) were followed for a median of 181 days (interquartile range [IQR] 84-240). Compliance was 96.4% (IQR 85.2 - 99.1%), with 10.8% of days missing. Factors positively associated with compliance were older age (p < 0.001), female sex (p < 0.001), higher e-diary grade (p < 0.001), and clinical use (p = 0.04). The e-diary received a median score of 8/10 and was well-liked by patients (n = 535) and providers (n = 23). Video consultations were a good alternative for physical visits according to 76.9% of patients and 84.6% of providers. Conclusion: Validated e-headache diaries and video consultations in telemedicine enhance headache care accessibility, providing convenient care at preferred times and locations.