Acceptability of an mHealth App for Monitoring Perinatal and Postpartum Mental Health: Qualitative Study With Women and Providers.

BACKGROUND: Up to 15% of pregnant and postpartum women commonly experience undiagnosed and untreated mental health conditions, such as depression and anxiety, which may result in serious health complications. Mobile health (mHealth) apps related to mental health have been previously used for early diagnosis and intervention but not among pregnant and postpartum women. OBJECTIVE: This study aims to assess the acceptability of using mHealth to monitor and assess perinatal and postpartum depression and anxiety. METHODS: Focus group discussions with pregnant and postpartum women (n=20) and individual interviews with health care providers (n=8) were conducted to inform the acceptability of mHealth and determine its utility for assessing perinatal and postpartum mood symptoms. Participants were recruited via purposive sampling from obstetric clinics and the surrounding community. A semistructured interview guide was developed by an epidemiologist with qualitative research training in consultation with an obstetrician. The first author conducted all focus group discussions and provider interviews either in person or via Zoom (Zoom Video Communications, Inc) depending on the COVID-19 protocol that was in place during the study period. All interviews were audio recorded with consent; transcribed; and uploaded for coding to ATLAS.ti 8 (ATLAS.ti Scientific Software Development Gmb H), a qualitative data analysis and retrieval software. Data were analyzed using the deductive content analysis method using a set of a priori codes developed based on the interview guide. Methodological rigor and quality were ensured by adopting a systematic approach during the implementation, data collection, data analysis, and reporting of the data. RESULTS: Almost all women and providers had downloaded and used at least 1 health app. The respondents suggested offering short questions in layperson language that could be understood by women of all educational levels and offering no more than 2 to 3 assessments per day at preferred timings decided by the women themselves. They also suggested that the women themselves receive the alerts first, with other options being family members, spouses, or friends if the women themselves did not respond within 24 to 72 hours. Customization and snooze features were strongly endorsed by women and providers to improve acceptability and utility. Women mentioned competing demands on their time during the postpartum period, fatigue, privacy, and the security of mental health data as concerns. Health care professionals highlighted the long-term sustainability of app-based mood assessment and monitoring as an important challenge. CONCLUSIONS: The findings from this study show that mHealth would be acceptable to pregnant and postpartum women for monitoring mood symptoms. This could inform the development of clinically meaningful and inexpensive tools for facilitating the continuous monitoring of, the early diagnosis of, and an early intervention for mood disorders in this vulnerable population.

Apropos of menstrual changes and abnormal uterine bleeding after COVID-19 vaccination.

It is news of 28 October 2022 that the Pharmacovigilance Risk Assessment Committee of the European Medicines Agency has recommended to add heavy menstrual bleeding among the side effects of unknown frequency inside the package insert of nucleoside-modified messenger ribonucleic acid vaccines to prevent coronavirus disease 2019 (COVID-19). The decision has been made in the light of the numerous reports of unexpected menstrual changes or abnormal uterine bleeding following COVID-19 vaccination. Here we advance a possible involvement of the particular adenohypophyseal microcirculation in these strange and still unexplained events.

Epidemiology of Pemphigus.

Pemphigus is an epidemiologically heterogeneous group of autoimmune bullous diseases comprising pemphigus vulgaris (PV), pemphigus foliaceus, paraneoplastic pemphigus, IgA pemphigus, and pemphigus herpetiformis. Recently, our knowledge about the frequency of pemphigus, which is highly variable between different populations, has considerably expanded, and the first non-HLA genes associated with PV have been identified. In addition, a variety of comorbidities, including other autoimmune diseases, hematological malignancies, and psoriasis, have been described in this variant. Here, initial data about the impact of COVID-19 on this fragile patient population are discussed and perspectives for future epidemiological studies are outlined.

Sleep and day-to-day PTSD symptom variability: an ecological momentary assessment and actigraphy monitored study in trauma-exposed young adults.

BACKGROUND: Disrupted sleep and post-traumatic stress disorder (PTSD) are bi-directionally linked and have been found to mutually reinforce each other on a day-to-day basis. However, most of the previous research has focused on subjective measures of sleep only. OBJECTIVE: Here, we investigated the temporal relationship between sleep and PTSD symptoms using both subjective (sleep diary) and objective measures of sleep (actigraphy). METHODS: Forty-one non-treatment seeking, trauma exposed young adults (age M = 24.68, SD = 8.15) with a range of PTSD symptom severities (PTSS, 0-53 on PCL-5) were recruited. Participants completed two surveys per day over four weeks to measure day-time PTSD symptoms (i.e. PTSS and number of intrusions) and night-time sleep subjectively, while wearing an actigraphy watch to measure sleep objectively. RESULTS: Linear mixed models revealed that subjectively reported sleep disruptions were associated with elevated next-day PTSS and increasing number of intrusive memories both within and between participants. Similar results were found for daytime PTSD symptoms on night-time sleep. However, these associations were not found using objective sleep data. Exploratory moderator analyses including sex (male vs. female) found that these associations differed in strength between sexes but were generally in the same direction. DISCUSSION: These results were in line with our hypothesis with regards to the sleep diary (subjective sleep), but not actigraphy (objective sleep). Several factors which have implications on both PTSD and sleep, such as the COVID-19 pandemic and/ or sleep-state misperception, may be potential reasons behind those discrepancies. However, this study had limited power and needs to be replicated in larger samples. Nonetheless, these results add to the current literature about the bi-directional relationship between sleep and PTSD and have clinical implications for treatment strategies.

Elevated day-time PTSD symptom severity (PTSS) and more frequent intrusive memories were generally associated with subjectively reported disruptions in sleep and vice versa, but not with objective measures of sleep.While longer subjective sleep duration predicted reductions in PTSS and shorter sleep onset latency predicted reduced numbers of intrusions the next day, reduced daytime PTSS was only associated with reductions in distress associated with nightmares during the following night.Exploratory analyses showed that sex (men vs. women) moderated the bi-directional relationships between night-time sleep and day-time PTSD symptoms with longer sleep onset latency and lower sleep efficiency being related to worse PTSD symptoms the next day in women, but was not associated with men.

Myocarditis following vaccination with Pfizer-BioNTech BNT162b2 against coronavirus infection (COVID-19)

Postvaccination myocarditis was reported as early as 1957 in association with smallpox vaccination. Following Emergency Use Authorization of the Pfizer-BioNTech BNT162b2 vaccine by the FDA on December 11, 2020, approval was granted in Israel on December 20, 2020. A national vaccination campaign for novel coronavirus infection (COVID-19) using the Pfizer vaccine ensued in Israel. The vaccination campaign was based on a 2-dose regimen administered with a 21-day interval, and later a third (booster) vaccine was added. A unique nationwide active surveillance program with hospital reports of diagnoses of myocarditis and verification of vaccinations. Based on comparisons with historical (pre-COVID-19) incidence of myocarditis, observed-to-expected ratios were calculated. The results clearly demonstrated an association between vaccination and myocarditis, mainly in young males and mainly in the first week after the second vaccine. These studies are the only nationwide active surveillance studies performed to date and provide the most accurate estimates of myocarditis occurrence after the Pfizer-BioNTech BNT162b2 mRNA-based vaccination. © 2023 Elsevier Inc. All rights reserved.

Making COVID-19 mRNA vaccines accessible: challenges resolved.

INTRODUCTION: The rapid spread of SARS-CoV2 infection allowed testing of mRNA vaccines that translate the target antigen, unlike introducing antigens in traditional vaccines. It proved safer and more effective and, as a chemical vaccine, much easier to develop and manufacture. AREAS COVERED: The science and technology behind the mRNA vaccines are pertinent to establishing low-cost manufacturing of reverse-engineered mRNA vaccines, as suggested by the WHO. A stepwise approach to establishing a compliant manufacturing facility, testing, supply chain, regulatory submissions, and intellectual property handling is presented. EXPERT OPINION: mRNA technology is more straightforward, and the cost of establishing a manufacturing facility is affordable, even in developing countries. The technology and supplies are widely available; however, based on experience, several misconceptions and misunderstandings about mRNA vaccines need to be removed, such as the regulatory and intellectual property issues that are resolved in this paper.

THE FUTURE OF REMOTE PHARMA GMP AUDITING

The COVID-19 pandemic saw pharma industry auditing move increasingly online and in place of on-site visits, we became familiar with virtual checks and inspections. Some auditors now say that virtual auditing could become a permanent solution, but deeper analysis shows that clients are not in favour of this option, says Alasdair Leckie, Operations Manager at Rephine Ltd. © 2022 TeknoScienze. All rights reserved.

Starting the conversation on gene therapy for phenylketonuria: Current perspectives of patients, caregivers, and advocates.

Phenylketonuria (PKU) is a rare genetic condition caused by inborn error(s) in the gene for the enzyme phenylalanine hydroxylase. Resulting loss of phenylalanine (Phe) metabolism requires strict dietary therapy and/or medication to prevent toxic accumulation of Phe. Novel investigational therapies, including gene therapies that aim to address underlying causes of PKU, are now entering clinical trials. However, perceptions of this technology in the PKU community have not been assessed. We conducted a qualitative survey recruiting adult patients, caregivers, and patient advocates from the US and 3 EU countries to assess the impact of living with PKU and the perceptions of gene therapy. Telephone interviews were conducted for up to 60 min following a standardized discussion guide. Interviewers classified each participant by their level of knowledge regarding gene therapy as either: low (little or no prior awareness); moderate (awareness of gene therapy as a concept in PKU); or high (working knowledge of gene therapy, e.g., vectors). In total, 33 participants were recruited (patients, n = 24; caregivers, n = 5; advocates, n = 4). The patient sample was well balanced among age groups, sex, and US/EU geographies. The participants' experiences and burden of living with PKU were largely negative, characterized by frustrations with current management consistent with prior reports. Most participants (n = 18/33) were identified as displaying moderate gene-therapy knowledge, 10/33 as displaying high knowledge, and 5/33 as displaying low knowledge. Both positive and negative perceptions were observed; positive perceptions were often linked to "hope" that gene therapy may represent a cure, whereas negative perceptions were linked to the "uncertainty" of outcomes. High knowledge of gene therapy appeared to trend with negative perceptions; 7/10 participants from this group reported high levels of concern over gene therapy. In contrast, participants who displayed low knowledge reported low (n = 3/5) or moderate (n = 2/5) concern, with predominantly positive perceptions. These data highlight the need for education around the theoretical risk:benefit profile of gene therapy. Despite current unknowns around gene therapy, our study demonstrates the important role of healthcare providers as educators who can use available data to provide balanced information to patients and caregivers.

EU expert panels for high-risk devices - another level of review?

The new EU regulations for medical device and in vitro diagnostic devices called for additional expert reviews for novel and high-risk devices. These newly formed committees have published three opinions for medical devices and fifteen opinions for IVDs. The opinions offer a detailed and critical review of data from both the manufacturer and notified body, which give insight into the nature of their review processes. In 2022, Regulation (EU) 2022/123 gave responsibility for the oversight of those expert panels to the EMA. This move suggests a more active role for the EMA in the approval of medical devices in ways that will impact future device submissions. The additional review will bring a new level of complexity and criticism into an already strained review process. Copyright © 2022, TOPRA. All rights reserved.

The effects of momentary loneliness and COVID-19 stressors on hypothalamic-pituitary adrenal (HPA) axis functioning: A lockdown stage changes the association between loneliness and salivary cortisol.

The COVID-19 pandemic can be characterized as a chronic stressor affecting the hypothalamic-pituitary-adrenal (HPA) axis, indexed by glucocorticoids (e.g., cortisol). We investigated whether salivary cortisol level is increased during a lockdown and whether a lockdown condition affects the association between loneliness, specific COVID-19 related stressors and salivary cortisol level. We conducted a smartphone-based ecological momentary assessment (EMA) study with 280 participants in Germany who experienced at least mild loneliness and distress amid COVID-19 from August 2020 to March 2021. We measured their momentary loneliness and COVID-related stressors including worries, information seeking behaviors and feelings of restriction during "no-lockdown" or "lockdown" stages amid COVID-19. Their salivary cortisol was measured 4 times on the last day of a 7-day EMA study. We found a significant increase in salivary cortisol levels during lockdown compared to no-lockdown. Lockdown stage was found to moderate the relationship between momentary loneliness and salivary cortisol level, i.e., loneliness was positively related to cortisol level specifically during lockdown. Mechanisms explaining the effect of forced social isolation on the association between loneliness and salivary cortisol need to be investigated in future studies.

Investigating Microtemporal Processes Underlying Health Behavior Adoption and Maintenance: Protocol for an Intensive Longitudinal Observational Study.

BACKGROUND: Young adulthood (ages 18-29 years) is marked by substantial weight gain, leading to increased lifetime risks of chronic diseases. Engaging in sufficient levels of physical activity and sleep, and limiting sedentary time are important contributors to the prevention of weight gain. Dual-process models of decision-making and behavior that delineate reflective (ie, deliberative, slow) and reactive (ie, automatic, fast) processes shed light on different mechanisms underlying the adoption versus maintenance of these energy-balance behaviors. However, reflective and reactive processes may unfold at different time scales and vary across people. OBJECTIVE: This paper describes the study design, recruitment, and data collection procedures for the Temporal Influences on Movement and Exercise (TIME) study, a 12-month intensive longitudinal data collection study to examine real-time microtemporal influences underlying the adoption and maintenance of physical activity, sedentary behavior, and sleep. METHODS: Intermittent ecological momentary assessment (eg, intentions, self-control) and continuous, sensor-based passive monitoring (eg, location, phone/app use, activity levels) occur using smartwatches and smartphones. Data analyses will combine idiographic (person-specific, data-driven) and nomothetic (generalizable, theory-driven) approaches to build models that may predict within-subject variation in the likelihood of behavior "episodes" (eg, ≥10 minutes of physical activity, ≥120 minutes of sedentary time, ≥7 hours sleep) and "lapses" (ie, not attaining recommended levels for ≥7 days) as a function of reflective and reactive factors. RESULTS: The study recruited young adults across the United States (N=246). Rolling recruitment began in March 2020 and ended August 2021. Data collection will continue until August 2022. CONCLUSIONS: Results from the TIME study will be used to build more predictive health behavior theories, and inform personalized behavior interventions to reduce obesity and improve public health. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/36666.

Promoting Daily Well-being in Adolescents using mHealth.

Adolescents are at increased risk for developing mental health problems. The Grow It! app is an mHealth intervention aimed at preventing mental health problems through improving coping by cognitive behavioral therapy (CBT)-inspired challenges as well as self-monitoring of emotions through Experience Sampling Methods (ESM). Yet, little is known about daily changes in well-being and coping during a stressful period, like the COVID-19 pandemic. The current study aimed to elucidate daily changes in positive and negative affect, and adaptive coping, and to better understand the within-person's mechanisms of the Grow It! app. The sample consisted of 12-25-year old Dutch adolescents in two independent cohorts (cohort 1: N = 476, Mage = 16.24, 76.1% female, 88.7% Dutch; cohort 2: N = 814, Mage = 18.45, 82.8% female, 97.2% Dutch). ESM were used to measure daily positive and negative affect and coping (cohort 1: 42 days, 210 assessments per person; cohort 2: 21 days, 105 assessments). The results showed that, on average, adolescents decreased in daily positive affect and adaptive coping, and increased in their experienced negative affect. A positive relation between adaptive coping and positive affect was found, although independent of the CBT-based challenges. Latent class analysis identified two heterogeneous trajectories for both positive and negative affect, indicating that the majority of participants with low to moderate-risk on developing mental health problems were likely to benefit from the Grow It! app.

Introduction to EMA's simplified requirements of package leaflets and labels for COVID-19 vaccines and therapeutics

EMA issued the Questions and answers on labelling flexibilities for COVID19 vaccines in December 2020 and the Labelling flexibilities for COVID-19 therapeutics in March 2021 to promote the development and application of COVID-19 vaccines and therapeutics in the EU. The two documents indicate that EMA has adopted flexible measures different from the conventional practice in the approval of the package leaflets and labels of the COVID-19 vaccines and therapeutics, so as to accelerate the approval of the package leaflets and labels of the COVID-19 vaccines and therapeutics. Among them, it mainly explains the specific simplified requirements, for example, it can only use English instead of national language;in the early stage, it can omit the packaging leaflet in the outer carton;the number of printed packaging leaflets can be less than the number of doses;in the early stage, some details can be omitted from the label, and so on. Although China has issued a series of guidelines on the COVID-19 vaccine, there are no packaging leaflets and labels involved. This paper introduces the two documents of EMA, which will have enlightenment for our work in this field. In particular, it has direct reference value for domestic vaccines used by EU Member States. © 2021 Tianjin Press of Chinese Herbal Medicines. All rights reserved.

A high-fibre personalised dietary advice given via a web tool reduces constipation complaints in adults.

Constipation can greatly impact the quality of life (QoL), which can be relieved by dietary fibres; however, preserving a higher fibre intake remains a challenge. We investigated the effects of a personalised dietary advice (PDA) on fibre intake and mild constipation complaints. A total number of twenty-five adults with mild constipation complaints were included in a 4-week observation period followed by a 4-week personalised intervention. The PDA provided high-fibre alternatives via a web tool. In weeks 1, 4 and 8, dietary intake, constipation complaints and QoL were assessed. Furthermore, participants collected a faecal sample at weeks 1, 4 and 8 to determine microbiota diversity and composition, and short-chain fatty acids (SCFA). Participants completed questions daily for 8 weeks regarding abdominal complaints, stool frequency and stool consistency. Fibre intake in week 8 was significantly higher compared to week 1 (Δ = 5·7 ± 6·7 g, P < 0·001) and week 4 (Δ = 5·2 ± 6·4 g, P < 0·001). Constipation severity and QoL significantly improved at week 8 compared to the observation period (P < 0·001). A higher fibre intake significantly reduced constipation severity (ß = -0·031 (-0·05; -0·01), P = 0·001) and the QoL (ß = -0·022 (-0·04; -0·01), P = 0·009). Stool consistency (P = 0·040) and abdominal pain (P = 0·030) improved significantly during the intervention period (P = 0·040), but stool frequency did not. Average microbial alpha diversity and composition and SCFA concentrations did not change over time, but indicated individual-specific dynamics. Several SCFAs were associated with constipation complaints. To conclude, a PDA effectively increased fibre intake and subsequently reduced constipation complaints, indicating that guided dietary adjustments are important and feasible in the treatment of mild constipation complaints.

SARS-COV-2 - the pandemic of the XXI century, clinical manifestations - neurological implications.

In December 2019, in Wuhan, China, the first cases of infection with SARS-CoV 2 responsible for COVID-19 disease were identified. SARS-CoV 2 was declared a pandemic on March 11, 2020, and since then has attracted the medical world's attention. The threat to humans' health that this emerging pandemic could leave raises awareness on the importance of understanding the mechanisms that underlie the developing conditions. The epidemiology, clinical picture, and pathogenesis of COVID-19 show that this virus presents new strategies to overcome the past defensive medicine. While all the current data has focused on the pulmonary and cardiovascular manifestations, little has been written about the neurological implications of the disease. This review updates new clinical aspects that SARS-CoV 2 expresses in humans by focusing primarily on neurological manifestations. The damage to the nervous system became more apparent - anosmia, ageusia, polyneuritis, meningitis, meningoencephalitis, stroke, acute necrotizing encephalopathy. Oxygen therapy is vital for those in critical health situations. Finally, prevention is the most important element in breaking the epidemiological chain.

“We’re Not Meant to Deal with Crisis for a Year”: Supporting Frontline Healthcare Providers’ Wellness During a Pandemic

The newly discovered respiratory disease, COVID-19, has caused significant physical and psychological strain for frontline healthcare providers (HCPs). Researchers have found higher levels of anxiety, stress, depression, and poor sleep quality in HCPs during this time. It is crucial to ensure the well-being of HCPs to secure a functioning health system amid a pandemic. This work explores how HCPs might interact with a Just-in-Time Adaptive Intervention (JITAI) system that collects their biopsychosocial metrics using off-the-shelf fitness trackers and ecological momentary assessments (EMAs) for providing actionable interventions in real-time. We found that different healthcare-related life factors influenced our participant HCPs’ engagement with the technological tools in the study. HCPs also expressed the need for better tools to help them convey their emotional exhaustion from a year-long pandemic. We also observed that HCPs sometimes could not maintain their psychological well-being due to other external factors, especially workload. These findings point to important design requirements for JITAIs to support frontline providers’ psychological well-being, both within healthcare and beyond. © 2022, ICST Institute for Computer Sciences, Social Informatics and Telecommunications Engineering.

Daily Food Insecurity Predicts Lower Positive and Higher Negative Affect: An Ecological Momentary Assessment Study.

Food insecurity (FI) is a dynamic phenomenon, and its association with daily affect is unknown. We explored the association between daily FI and affect among low-income adults during a 2-seasonal-month period that covered days both pre- and during the COVID-19 pandemic. A total of 29 healthy low-income adults were recruited during fall in 2019 or 2020, 25 of whom were followed in winter in 2020 or 2021. Daily FI (measured once daily) and affect (measured 5 times daily) were collected over the 2nd-4th week in each month. Time-Varying-Effect-Models were used to estimate the association between daily FI and positive/negative affect (PA/NA). Overall, 902 person-days of daily-level data were collected. Daily FI was associated with lower PA in the 3rd and 4th week of fall and winter and with higher NA in the second half of winter months. Similar patterns of FI-affect relations were found pre- and during COVID-19 in the second half of a given month, while unique patterns of positive affect scores in the 2nd week and negative scores in the 1st week were only observed during COVID days. Our study supports a time-varying association between FI and affect in low-income adults. Future large studies are needed to verify the findings; ultimately, better understanding such associations may help identify, target, and intervene in food insecure adults to prevent adverse mental health outcomes.

Advances in the development of therapeutic strategies against COVID-19 and perspectives in the drug design for emerging SARS-CoV-2 variants.

Since Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) was identified in late 2019, the coronavirus disease 2019 (COVID-19) pandemic has challenged public health around the world. Currently, there is an urgent need to explore antiviral therapeutic targets and effective clinical drugs. In this study, we systematically summarized two main therapeutic strategies against COVID-19, namely drugs targeting the SARS-CoV-2 life cycle and SARS-CoV-2-induced inflammation in host cells. The development of above two strategies is implemented by repurposing drugs and exploring potential targets. A comprehensive summary of promising drugs, especially cytokine inhibitors, and traditional Chinese medicine (TCM), provides recommendations for clinicians as evidence-based medicine in the actual clinical COVID-19 treatment. Considering the emerging SARS-CoV-2 variants greatly impact the effectiveness of drugs and vaccines, we reviewed the appearance and details of SARS-CoV-2 variants for further perspectives in drug design, which brings updating clues to develop therapeutical agents against the variants. Based on this, the development of broadly antiviral drugs, combined with immunomodulatory, or holistic therapy in the host, is prior to being considered for therapeutic interventions on mutant strains of SARS-CoV-2. Therefore, it is highly acclaimed the requirements of the concerted efforts from multi-disciplinary basic studies and clinical trials, which improves the accurate treatment of COVID-19 and optimizes the contingency measures to emerging SARS-CoV-2 variants.