Lessons learned from a pilot implementation of physical activity recommendations in axial spondyloarthritis exercise group therapy

Background The Ankylosing Spondylitis Association of Switzerland (SVMB) aimed to implement physical activity recommendations (PAR) within their exercise groups (EGs). The PAR promote exercise in all fitness dimensions at the correct dose. To implement the PAR within EGs, they were translated into a new EG concept with five key activities: (a) training for supervising physiotherapists (PTs), (b) correctly dosed exercises in all fitness dimensions, (c) exercise counselling, (d) bi-annual fitness assessments, and (e) individual exercise training, in addition to EG. All these activities were realized in close coordination with SVMB management. Objectives To analyse the implementation success by evaluating adherence/fidelity, feasibility, and satisfaction at the patient, PTs, and organisational level. Methods The five key activities of the new EG concept were developed, executed, and assessed after 6 months. The primary outcomes for implementation success were adherence of patients to the recommended exercise behaviour, self-reported by electronic diary; fidelity of PTs to the new concept, self-reported by diary; SVMB organisational changes. Secondary outcomes were feasibility and satisfaction with the new EG concept at all three levels. The tertiary outcome, to evaluate the effectiveness of PAR, was patient fitness, assessed through fitness assessments. Results 30 patients with axSpA (ten women, mean age 58 ± 9 years) and four PTs (three women, mean age 46 ± 9 years) participated. The patients' self-reporting of adherence to the PAR was insufficient (43%), possibly due to technical problems with the electronic dairy. The PTs' fidelity to the new EG concept was satisfactory. On all levels, the new concept was generally perceived as feasible and useful for supporting personalised exercise.The frequency of exercise counselling and the fitness assessments was found by patients and PTs to be too high and rigid. Patients' cardiorespiratory fitness [ES 1.21 (95%CI 0.59, 1.89)] and core strength [ES 0.61 (95%CI 0.18, 1.06)] improved over the 6 months. Conclusions The pilot implementation of PAR showed acceptance and satisfaction to be sufficient, thus confirming the need for evidence-based EGs, provided by a patient organisation in order to support active PA behaviour. However, adaptations are necessary to increase its feasibility for nationwide implementation. Trial Registration: SNCTP, SNCTP000002880. Registered 31 May 2018, https://www.kofam.ch/en/snctp-portal/search/0/study/42491.

Use of the ONCO-TreC electronic diary compared with a standard paper diary to improve adherence to oral cancer therapy in patients with solid and haematological tumours: protocol for a randomised controlled trial

IntroductionONCO-TreC platform consists of a mobile application delivered to patients as electronic diary and a web-based dashboard managed by healthcare professionals. We aim to compare the effectiveness of ONCO-TreC electronic diary with a standard paper diary, in improving adherence to oral cancer therapy in patients with solid and haematological tumours.Methods and analysisThis is an open label, superiority, randomised controlled trial conducted in two Italian oncology units. Patients will be randomised with a 1:1 ratio to electronic or paper diary. For both groups a counsellor will be responsible for drug and diary delivery. The evaluation period will end after six cycles of therapy. The primary aim is to compare the proportion of non-adherent patients in the two arms. Adherence will be measured through pill count; anyone who takes less than 90% of the total prescribed drug dose will be considered non-adherent. Assuming a percentage of non-adherent patients to oral therapy of 40% in arm B, and a 60% reduction in this percentage in arm A, a sample of 124 patients will provide 80% power to identify an absolute difference greater than 24 percentage points using a bilateral Fisher’s exact test with a significance level of 0.05. Considering a dropout rate of 10%, approximately 136 patients will have to be enrolled. The primary analysis will be performed on the intention-to-treat population. Secondary aims are to describe the reasons for non-adherence, the level of satisfaction of patients and healthcare professionals with the paper and electronic diary, and the impact of non-adherence in terms of healthcare costs.Ethics and disseminationEthical approval was obtained from Romagna Ethics Committee (CEROM), study ID 2108, prot. n. IRST 100.28 of 10/04/2020. Informed consent will be obtained from all study participants. Findings will be disseminated through peer-reviewed journals, conferences and event presentations.Protocol versionVersion 2, 6 April 2021.Trial registration numberNCT04826458.

Exploring the clinical usefulness of an electronic diary in fibromyalgia patients: A pilot study

This study examines the usefulness of an electronic diary (ED) in the monitoring of clinical manifestations of fibromyalgia (FM), compared to traditional pencil-and-paper self-reports. Fourteen women with FM completed an interview, several questionnaires, and an ED for a week (several times a day) recording pain, fatigue, sleep, difficulty in thinking, emotional distress, difficulty in daily functioning, and coping with the disease, and stress. There were no differences in the symptoms throughout the moments of the day, observing a sleep latency of 45.36 minutes and sleep duration of 6.25 hours. Significant correlations were found between ED measures depending on the time of day, and between ED measures and questionnaires. The ED showed to be useful for the evaluation of FM symptomatology, and can be a key component in psychological intervention programs.

A Dyadic Investigation of Depressed Affect and Interspousal Behavior in Couples With Chronic Back Pain

Background Depression and marital discord are characteristic not only of individuals with chronic low back pain (ICPs) but also of their spouses. Purpose We examined actor–partner interdependence models to evaluate associations among depressed affect and criticism and support of partners at the same time point (concurrent effects) and 3 hr later (lagged effects). Fully dyadic models were used to account for both within-person and cross-spouse associations among depressed affect, criticism, and support for ICPs and spouses. We also examined the direction of the relationships (depressed affect predicting behavior and behavior predicting depressed affect) all while controlling for pain intensity, pain behavior, and the prior dependent variable. Methods ICPs (n = 105) and their spouses completed electronic diary measures of depressed affect and behavior (criticism and support) five times a day for 2 weeks. Hierarchical linear modeling with person-mean centering was used for data analysis. Results Within the same 3 hr epoch, more depressed affect was related to higher criticism and generally less support. Lagged analyses suggested bidirectional relationships between spouse’s own depressed affect and spouse’s own criticism of ICPs. Spouse depressed affect was also associated with decreased support received from ICPs. Pain behavior and pain intensity were also related to depressed affect, criticism, and support especially concurrently. Conclusions Theories and interventions need to address not only ICP depressed affect but also spouse depressed affect, as spouse depressed affect may be a stress generating precursor to criticism and support.

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.

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.

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

Background Viral 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. Methods This 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. Results Twenty 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. Conclusion In 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 months

Background In 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. Methods This 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. Results Of 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). Conclusions In 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.

Safety and Immunogenicity of CoronaVac and ChAdOx1 Against the SARS-CoV-2 Circulating Variants of Concern (Alpha, Delta, Beta) in Thai Healthcare Workers

Importance: Inactivated vaccine (CoronaVac) and chimpanzee adenovirus-vector vaccine (ChAdOx1) have been more available in resource-limited settings. However, the data comparing between these two vaccines in the same setting are limited. Objectives: To determine adverse events (AEs) and immunogenicity of CoronaVac and ChAdOx1 in health care workers (HCWs). Design: This prospective study was conducted from February to July 2021. Setting: A single center, university-based tertiary care center in Bangkok. Participants: Healthy HCWs. Exposure: Two doses of CoronaVac (4 weeks apart) or ChAdOx1 (8 weeks apart) intramuscularly. Main Outcomes and Measures: Self-reported AEs were collected for 7 days following each vaccination using electronic diary. The immunogenicity was determined by the level of IgG antibodies against receptor binding domain (RBD) of the SARS-CoV-2 spike protein (S1 subunit). The 50% plaque reduction neutralization tests against original Wuhan strain and circulating VOCs were performed in subset of samples at 2 weeks after the second dose. Results: Of the 360 HCWs, 180 received each vaccine. The median (interquartile range: IQR) age was 35 (29-44) years old and 84.2% were female. Participants who received ChAdOx1 reported higher frequency of AEs than those received CoronaVac after both the first dose (84.4% vs. 66.1%, P < 0.001) and second dose (75.6% vs. 60.6%, P = 0.002), with more AEs in those younger than 30 years of age for both vaccines. The seroconversion rate was 75.6% and 100% following the first dose of CoronaVac and ChAdOx1, respectively. All participants seroconverted at 2 weeks after the second dose. The anti-SARS-CoV-2 RBD IgG levels induced by CoronaVac was lower than ChAdOX1 with geometric means of 164.4 and 278.5 BAU/mL, respectively (P = 0.0066). Both vaccines induced similar levels of neutralizing antibodies against the Wuhan strain, geometric mean titer (GMT) of 337.4 vs 331.2; however, CoronaVac induced significantly lower GMT against Alpha (23.1 vs. 92.5), Delta (21.2 vs. 69.7), and Beta (10.2 vs. 43.6) variants, respectively. Conclusions and Relevance: CoronaVac induces lower measurable antibodies but with lower frequency of AEs than ChAdOx1. The low neutralizing antibodies against the circulating VOCs induced by CoronaVac supports the need for earlier boosting to prevent breakthrough infections. Trial Registration: TCTR20210720002 https://www.thaiclinicaltrials.org/