In response to the COVID-19 pandemic, we rapidly implemented a plasma coordination center, within two months, to support transfusion for two outpatient randomized controlled trials. The center design was based on an investigational drug services model and a Food and Drug Administration-compliant database to manage blood product inventory and trial safety.

A core investigational team adapted a cloud-based platform to randomize patient assignments and track inventory distribution of control plasma and high-titer COVID-19 convalescent plasma of different blood groups from 29 donor collection centers directly to blood banks serving 26 transfusion sites.

We performed 1,351 transfusions in 16 months. The transparency of the digital inventory at each site was critical to facilitate qualification, randomization, and overnight shipments of blood group-compatible plasma for transfusions into trial participants. While inventory challenges were heightened with COVID-19 convalescent plasma, the cloud-based system, and the flexible approach of the plasma coordination center staff across the blood bank network enabled decentralized procurement and distribution of investigational products to maintain inventory thresholds and overcome local supply chain restraints at the sites.

The rapid creation of a plasma coordination center for outpatient transfusions is infrequent in the academic setting. Distributing more than 3,100 plasma units to blood banks charged with managing investigational inventory across the U.S. in a decentralized manner posed operational and regulatory challenges while providing opportunities for the plasma coordination center to contribute to research of global importance. This program can serve as a template in subsequent public health emergencies.

Despite high levels of psychological distress, mental health service use among Syrian refugees in urban settings is low. To address the mental healthcare gap, the World Health Organization developed group problem management plus (gPM+), a scalable psychological intervention delivered by non-specialist peer facilitators. The study aimed to evaluate the effectiveness of gPM+ in reducing symptoms of depression and anxiety among Syrian refugees in Istanbul, Türkiye.

A randomized controlled trial was conducted among 368 distressed (Kessler Psychological Distress Scale, K10 > 15) adult Syrian refugees with impaired functioning (World Health Organization Disability Assessment Schedule, WHODAS 2.0 > 16). Participants were recruited between August 2019 and September 2020 through a non-governmental organization providing services to refugees. Participants were randomly allocated to gPM+ and enhanced care as usual (gPM+/E-CAU) (184 participants) or E-CAU only (184 participants). Primary outcomes were symptoms of depression and anxiety (Hopkins Symptom Checklist (HSCL-25)) at 3-month follow-up. Secondary outcomes were post-traumatic stress disorder (PTSD) symptoms (PTSD Checklist for Diagnostic and Statistical Manual of Mental Disorders-5; PCL-5), functional impairment (WHODAS 2.0), and self-identified problems (psychological outcome profiles).

Intent-to-treat analyses showed no significant effect of gPM+ on symptoms of anxiety, depression, PTSD and self-identified problems. Yet, there was a significant reduction in functional impairment in gPM+/E-CAU compared to E-CAU at 3-month follow-up (adjusted mean difference 1.66, 95 % CI 0.04, 3.27, p = 0.045, d = 0.19). Post-hoc subgroup analyses among participants with probable baseline depression or anxiety showed that there was a small but significant reduction in depression (adjusted mean difference −0.17, 95 % CI −0.32, −0.02, p = 0.028, d = 0.27) and anxiety (adjusted mean difference −0.21, 95 % CI −0.37, −0.05, p = 0.009, d = 0.30) symptoms comparing gPM+/E-CAU to E-CAU only at 1-week post assessment, but not at 3-month follow-up. There was a significant difference between conditions on functional impairment at 3-month follow-up, favouring gPM+/E-CAU condition (adjusted mean difference −1.98, 95 % CI −3.93, −0.02, p = 0.048, d = 0.26).

In this study in an urban setting in Türkiye, gPM+ did not alleviate symptoms of depression and anxiety among Syrian refugees experiencing psychological distress and daily living difficulties. However, participants with higher distress at baseline seemed to benefit from gPM+, but treatment gains disappeared in the long term. Current findings highlight the potential benefit of tailored psychosocial interventions for highly distressed refugees in volatile low-resource settings.

Population-wide restrictions during the COVID-19 pandemic may create barriers to mental health diagnosis. This study aims to examine changes in the number of incident cases and the incidence rates of mental health diagnoses during the COVID-19 pandemic.

By using electronic health records from France, Germany, Italy, South Korea and the UK and claims data from the US, this study conducted interrupted time-series analyses to compare the monthly incident cases and the incidence of depressive disorders, anxiety disorders, alcohol misuse or dependence, substance misuse or dependence, bipolar disorders, personality disorders and psychoses diagnoses before (January 2017 to February 2020) and after (April 2020 to the latest available date of each database [up to November 2021]) the introduction of COVID-related restrictions.

A total of 629,712,954 individuals were enrolled across nine databases. Following the introduction of restrictions, an immediate decline was observed in the number of incident cases of all mental health diagnoses in the US (rate ratios (RRs) ranged from 0.005 to 0.677) and in the incidence of all conditions in France, Germany, Italy and the US (RRs ranged from 0.002 to 0.422). In the UK, significant reductions were only observed in common mental illnesses. The number of incident cases and the incidence began to return to or exceed pre-pandemic levels in most countries from mid-2020 through 2021.

Healthcare providers should be prepared to deliver service adaptations to mitigate burdens directly or indirectly caused by delays in the diagnosis and treatment of mental health conditions.

Self-compassion (SC) describes an emotionally positive attitude extended toward ourselves when we suffer, consisting of three main components; self-kindness, common humanity, and mindfulness (Germer & Neff, 2013). SC entails being warm and understanding towards ourselves when encountering pain or personal shortcomings, rather than ignoring them or flagellating ourselves with self-criticism. SC also involves recognizing that suffering and failure are part of the shared human experience rather than isolating. In addition, SC requires taking a mindful approach to one’s feelings and thoughts, without judgment of them.

Self-compassion (SC) involves taking an emotionally positive attitude towards oneself when suffering. Although SC has positive effects on mental well-being as well as a protective role in preventing depression and anxiety in healthy individuals, few studies on white matter (WM) microstructures in neuroimaging studies of SC has been studied.

Magnetic resonance imaging data were acquired from 71 healthy participants with measured levels of SC and its six subscales. Mirroring network as WM regions of interest were analyzed using tract-based spatial statistics (TBSS). After the WM regions associated with SC were extracted, exploratory correlation analysis with the self-forgiveness scale, the coping scale, and the world health organization quality of life scale abbreviated version was performed.

We found that self-compassion scale (SCS) total scores were negatively correlated with the fractional anisotropy (FA) values of the superior longitudinal fasciculus (SLF) in healthy individuals. The self-kindness and mindfulness subscale scores of SCS were also negatively correlated with FA values of the same regions. The FA values of SLF related to SC were found to be negatively correlated with the total scores of self-forgiveness scale, and self-control coping strategy and confrontation coping strategy.

Our findings suggest that levels of SC and its self-kindness and mindfulness components may be negatively associated with DMN-related WM microstructures in healthy individuals. These less WM microstructures may be associated with positive personal attitudes, such as self-forgiveness, self-control and active confrontational strategies.

None Declared

Several studies have reported on the feasibility and impact of e-monitoring using computers, or smartphones, in patients with mental disorders, including Bipolar Disorder (BD). Despite some promising early results, concerns have been raised about the motivation and ability of patients with BD to adhere to e-monitoring, in particular when they are depressed or manic. While studies on e-monitoring have examined the role of demographic factors, such as age, gender, or socioeconomic status and use of health apps, to our knowledge, no study has examined clinical characteristics that might impact adherence with e-monitoring of patients with BD.

We analyzed adherence to e-monitoring in patients with BD who participated in an ongoing e-monitoring study and evaluated whether demographic and clinical factors would predict adherence.

Eighty-seven participants with BD in different phases of the illness were included. Patterns of adherence for wearable use, daily and weekly self-rating scales over 15 months were analyzed to identify adherence trajectories using growth mixture models (GMM). Multinomial logistic regression models and Multiple Component Analyses were fitted to compute the effects of predictors on GMM classes.

Adherence rates were 79.5% for the wearable; 78.5% for weekly self-ratings; and 74.6% for daily self-ratings. GMM identified three latent class subgroups: (i) participants with good adherence with the protocol; (ii) participants with partial adherence; (iii) participants with poor adherence. Women, participants with a history of suicide attempt, and those with a history of inpatient admission were more likely to belong to the group with good adherence.

Participants with higher illness burden (e.g., history of admission to hospital, history of suicide attempts) have higher adherence rates to e-monitoring. This is important because our findings debunk myths around illness burden as an obstacle to adhere to e-monitoring studies. Participants might have seen e-monitoring as a tool for better documenting symptom change and better managing their illness, thus motivating their engagement.

None Declared

The true incidence and risk factors for secondary bacterial infections in coronavirus disease 2019 (COVID-19) remains poorly understood. Knowledge of risk factors for secondary infections in hospitalized patients with COVID-19 is necessary to optimally guide selective use of empiric antimicrobial therapy.

Single-center retrospective cohort study of symptomatic inpatients admitted for COVID-19 from April 15, 2020, through June 30, 2021.

Academic quaternary-care referral center in Portland, Oregon.

The study included patients who were 18 years or older with a positive severe acute respiratory coronavirus virus 2 (SARS-CoV-2) PCR test up to 10 days prior to admission.

Secondary infections were identified based on clinical, radiographic, and microbiologic data. Logistic regression was used to identify risk factors for secondary infection. We also assessed mortality, length of stay, and empiric antibiotics among those with and without secondary infections.

We identified 118 patients for inclusion; 31 (26.3%) had either culture-proven or possible secondary infections among hospitalized patients with COVID-19. Mortality was higher among patients with secondary infections (35.5%) compared to those without secondary infection (4.6%). Empiric antibiotic use on admission was high in both the secondary and no secondary infection groups at 71.0% and 48.3%, respectively.

The incidence of secondary bacterial infection was moderate among hospitalized patients with COVID-19. However, a higher proportion of patients received empiric antibiotics regardless of an identifiable secondary infection. Transfer from an outside hospital, baseline immunosuppressant use, and corticosteroid treatment were independent risk factors for secondary infection. Additional studies are needed to validate risk factors and best guide antimicrobial stewardship efforts.

Dental healthcare personnel (DHCP) are at high risk of exposure to coronavirus disease 2019 (COVID-19). We sought to identify how DHCP changed their use of personal protective equipment (PPE) as a result of the COVID-19 pandemic, and to pilot an educational video designed to improve knowledge of proper PPE use.

The study comprised 2 sets of semistructured qualitative interviews.

The study was conducted in 8 dental clinics in a Midwestern metropolitan area.

In total, 70 DHCP participated in the first set of interviews; 63 DHCP participated in the second set of interviews.

In September–November 2020 and March–October 2021, we conducted 2 sets of semistructured interviews: (1) PPE use in the dental community during COVID-19, and (2) feedback on the utility of an educational donning and doffing video.

Overall, 86% of DHCP reported having prior training. DHCP increased the use of PPE during COVID-19, specifically N95 respirators and face shields. DHCP reported real-world challenges to applying infection control methods, often resulting in PPE modification and reuse. DHCP reported double masking and sterilization methods to extend N95 respirator use. Additional challenges to PPE included shortages, comfort or discomfort, and compatibility with specialty dental equipment. DHCP found the educational video helpful and relevant to clinical practice. Fewer than half of DHCP reported exposure to a similar video.

DHCP experienced significant challenges related to PPE access and routine use in dental clinics during the COVID-19 pandemic. An educational video improved awareness and uptake of appropriate PPE use among DHCP.

Health services research (HSR) is affected by a widespread problem related to service terminology including non-commensurability (using different units of analysis for comparisons) and terminological unclarity due to ambiguity and vagueness of terms. The aim of this study was to identify the magnitude of the terminological bias in health and social services research and health economics by applying an international classification system.

This study, that was part of the PECUNIA project, followed an ontoterminology approach (disambiguation of technical and scientific terms using a taxonomy and a glossary of terms). A listing of 56 types of health and social services relevant for mental health was compiled from a systematic review of the literature and feedback provided by 29 experts in six European countries. The disambiguation of terms was performed using an ontology-based classification of services (Description and Evaluation of Services and DirectoriEs – DESDE), and its glossary of terms. The analysis focused on the commensurability and the clarity of definitions according to the reference classification system. Interrater reliability was analysed using κ.

The disambiguation revealed that only 13 terms (23%) of the 56 services selected were accurate. Six terms (11%) were confusing as they did not correspond to services as defined in the reference classification system (non-commensurability bias), 27 (48%) did not include a clear definition of the target population for which the service was intended, and the definition of types of services was unclear in 59% of the terms: 15 were ambiguous and 11 vague. The κ analyses were significant for agreements in unit of analysis and assignment of DESDE codes and very high in definition of target population.

Service terminology is a source of systematic bias in health service research, and certainly in mental healthcare. The magnitude of the problem is substantial. This finding has major implications for the international comparability of resource use in health economics, quality and equality research. The approach presented in this paper contributes to minimise differentiation between services by taking into account key features such as target population, care setting, main activities and type and number of professionals among others. This approach also contributes to support financial incentives for effective health promotion and disease prevention. A detailed analysis of services in terms of cost measurement for economic evaluations reveals the necessity and usefulness of defining services using a coding system and taxonomical criteria rather than by ‘text-based descriptions’.

To investigate the association between parity and the risk of incident dementia in women.

We pooled baseline and follow-up data for community-dwelling women aged 60 or older from six population-based, prospective cohort studies from four European and two Asian countries. We investigated the association between parity and incident dementia using Cox proportional hazards regression models adjusted for age, educational level, hypertension, diabetes mellitus and cohort, with additional analysis by dementia subtype (Alzheimer dementia (AD) and non-Alzheimer dementia (NAD)).

Of 9756 women dementia-free at baseline, 7010 completed one or more follow-up assessments. The mean follow-up duration was 5.4 ± 3.1 years and dementia developed in 550 participants. The number of parities was associated with the risk of incident dementia (hazard ratio (HR) = 1.07, 95% confidence interval (CI) = 1.02–1.13). Grand multiparity (five or more parities) increased the risk of dementia by 30% compared to 1–4 parities (HR = 1.30, 95% CI = 1.02–1.67). The risk of NAD increased by 12% for every parity (HR = 1.12, 95% CI = 1.02–1.23) and by 60% for grand multiparity (HR = 1.60, 95% CI = 1.00–2.55), but the risk of AD was not significantly associated with parity.

Grand multiparity is a significant risk factor for dementia in women. This may have particularly important implications for women in low and middle-income countries where the fertility rate and prevalence of grand multiparity are high.

Common mental disorders are highly prevalent among Syrian refugees. Problem Management Plus (PM+) is a brief, transdiagnostic, non-specialist helper delivered, psychological intervention targeting psychological distress. This single-blind pilot randomised controlled trial (RCT) on PM+ delivered by peer-refugees examined trial procedures in advance of a definitive RCT, evaluated PM+ 's acceptability and feasibility, and investigated its likely effectiveness and cost-effectiveness among Syrian refugees in the Netherlands.

Adult Syrian refugees (N = 60) with elevated psychological distress (Kessler Psychological Distress Scale (K10) score >15) and reduced pychosocial functioning (WHO Disability Assessment Schedule 2.0 (WHODAS) score >16) were randomised into PM+ in addition to care as usual (CAU) (PM+/CAU; n = 30) or CAU alone (n = 30). Primary outcomes were symptoms of depression and anxiety (Hopkins Symptom Checklist; HSCL-25) at 3-month follow-up. Secondary outcomes were pychosocial functioning (WHO Disability Assessment Schedule; WHODAS 2.0), symptoms of posttraumatic stress disorder (PTSD) (PTSD Checklist for DSM 5; PCL-5) and self-identified problems (Psychological Outcomes Profiles; PSYCHLOPS). Changes in service utilisation and time out of employment and/or adult education were estimated (adapted version of the Client Service Receipt Inventory; CSRI). Semi-structured interviews on the implementation of PM+ were conducted with stakeholders (i.e. six PM+ participants, five non-specialist helpers and five key informants).

Recruitment, randomization and blinding procedures were successful. PM+ was generally perceived positively by stakeholders, especially regarding the intervention strategies, accommodation of the intervention and the helpers. Two serious adverse events not attributable to the trial were reported. At 3-month follow-up, the HSCL-25 total score was significantly lower for the PM+/CAU group (n = 30) than CAU group (n = 30) (p = 0.004; d = 0.58). Significant differences in favour of PM+/CAU were also found for WHODAS psychosocial functioning (p = 0.009, d = 0.73), PCL-5 symptoms of PTSD (p = 0.006, d = 0.66) and PSYCHLOPS self-identified problems (p = 0.005, d = 0.81). There were no significant differences in mean health service costs (p = 0.191) and the mean costs of lost productive time (p = 0.141). This suggests PM+ may potentially be cost-effective with an incremental cost from a health system perspective of €5047 (95% CI €0–€19 773) per additional recovery achieved.

Trial procedures and PM+ delivered by non-specialist peer-refugee helpers seemed acceptable, feasible and safe. Analyses indicate that PM+ may be effective in improving mental health outcomes and psychosocial functioning, and potentially cost-effective. These results support the development of a definitive RCT with a larger sample of refugees and a longer follow-up period.

To characterize the spectrum of BRCA1 and BRCA2 pathogenic germline variants in women from south-west Poland and west Ukraine affected with breast or ovarian cancer. Testing in women at high risk of breast and ovarian cancer in these regions is currently mainly limited to founder mutations.

Unrelated women affected with breast and/or ovarian cancer from Poland (n = 337) and Ukraine (n = 123) were screened by targeted sequencing. Excluded from targeted sequencing were 34 Polish women who had previously been identified as carrying a founder mutation in BRCA1. No prior testing had been conducted among the Ukrainian women. Thus, this study screened BRCA1 and BRCA2 in the germline DNA of 426 women in total.

We identified 31 and 18 women as carriers of pathogenic/likely pathogenic (P/LP) genetic variants in BRCA1 and BRCA2, respectively. We observed five BRCA1 and eight BRCA2 P/LP variants (13/337, 3.9%) in the Polish women. Combined with the 34/337 (10.1%) founder variants identified prior to this study, the overall P/LP variant frequency in the Polish women was thus 14% (47/337). Among the Ukrainian women, 16/123 (13%) women were identified as carrying a founder mutation and 20/123 (16.3%) were found to carry non-founder P/LP variants (10 in BRCA1 and 10 in BRCA2).

These results indicate that genetic testing in women at high risk of breast and ovarian cancer in Poland and Ukraine should not be limited to founder mutations. Extended testing will enhance risk stratification and management for these women and their families.