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It remains unclear which individuals with subthreshold depression benefit most from psychological intervention, and what long-term effects this has on symptom deterioration, response and remission.
Aims
To synthesise psychological intervention benefits in adults with subthreshold depression up to 2 years, and explore participant-level effect-modifiers.
Method
Randomised trials comparing psychological intervention with inactive control were identified via systematic search. Authors were contacted to obtain individual participant data (IPD), analysed using Bayesian one-stage meta-analysis. Treatment–covariate interactions were added to examine moderators. Hierarchical-additive models were used to explore treatment benefits conditional on baseline Patient Health Questionnaire 9 (PHQ-9) values.
Results
IPD of 10 671 individuals (50 studies) could be included. We found significant effects on depressive symptom severity up to 12 months (standardised mean-difference [s.m.d.] = −0.48 to −0.27). Effects could not be ascertained up to 24 months (s.m.d. = −0.18). Similar findings emerged for 50% symptom reduction (relative risk = 1.27–2.79), reliable improvement (relative risk = 1.38–3.17), deterioration (relative risk = 0.67–0.54) and close-to-symptom-free status (relative risk = 1.41–2.80). Among participant-level moderators, only initial depression and anxiety severity were highly credible (P > 0.99). Predicted treatment benefits decreased with lower symptom severity but remained minimally important even for very mild symptoms (s.m.d. = −0.33 for PHQ-9 = 5).
Conclusions
Psychological intervention reduces the symptom burden in individuals with subthreshold depression up to 1 year, and protects against symptom deterioration. Benefits up to 2 years are less certain. We find strong support for intervention in subthreshold depression, particularly with PHQ-9 scores ≥ 10. For very mild symptoms, scalable treatments could be an attractive option.
Partial remission after major depressive disorder (MDD) is common and a robust predictor of relapse. However, it remains unclear to which extent preventive psychological interventions reduce depressive symptomatology and relapse risk after partial remission. We aimed to identify variables predicting relapse and to determine whether, and for whom, psychological interventions are effective in preventing relapse, reducing (residual) depressive symptoms, and increasing quality of life among individuals in partial remission. This preregistered (CRD42023463468) systematic review and individual participant data meta-analysis (IPD-MA) pooled data from 16 randomized controlled trials (n = 705 partial remitters) comparing psychological interventions to control conditions, using 1- and 2-stage IPD-MA. Among partial remitters, baseline clinician-rated depressive symptoms (p = .005) and prior episodes (p = .012) predicted relapse. Psychological interventions were associated with reduced relapse risk over 12 months (hazard ratio [HR] = 0.60, 95% confidence interval [CI] 0.43–0.84), and significantly lowered posttreatment depressive symptoms (Hedges’ g = 0.29, 95% CI 0.04–0.54), with sustained effects at 60 weeks (Hedges’ g = 0.33, 95% CI 0.06–0.59), compared to nonpsychological interventions. However, interventions did not significantly improve quality of life at 60 weeks (Hedges’ g = 0.26, 95% CI -0.06 to 0.58). No moderators of relapse prevention efficacy were found. Men, older individuals, and those with higher baseline symptom severity experienced greater reductions in symptomatology at 60 weeks. Psychological interventions for individuals with partially remitted depression reduce relapse risk and residual symptomatology, with efficacy generalizing across patient characteristics and treatment types. This suggests that psychological interventions are a recommended treatment option for this patient population.
Over a 2-year period, we identified Transmission from Room Environment Events (TREE) across the Johns Hopkins Health System, where the subsequent room occupant developed the same organism with the same antimicrobial susceptibilities as the patient who had previously occupied that room. Overall, the TREE rate was 50/100,000 inpatient days.
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.
Methods:
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.
Results:
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.
Conclusion:
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.
Participatory research (PF) actively involves people with lived experience (pwle), e.g. for a disease, in research. This improves the relevance, quality and impact of research and can help to raise third-party funds, increase recruitment numbers, select research methods. Pwle can support all stages of the research process, including dissemination. While PF is already standard in other countries, Germany is still lagging behind. Our participatory advisory board aims to create a sustainable structure to involve underrepresented patients.
Objectives
In the PART advisory board, pwle and researchers should actively cooperate in projects in the field of forensic psychiatry. In preparation to establish the advisory board procedures, key documents and training material were developed. In addition experiences, opinions, ideas and concerns of stakeholders and pwle in relation to PF were collected.
Methods
Guided interviews were conducted with stakeholders (clinical, research) and focus groups with in-patient pwle from forensic psychiatry. They were asked how they imagine the structure, tasks and goals of a participatory advisory board, what opportunities and obstacles they see. Anticipated framework conditions and support needs for the successful implementation were also asked. The interviews and focus groups were audio-recorded and transcribed. Data was analysed with MAXQDA using thematic analysis.
Results
In total, 8 expert interviews and 2 focus groups with 15 pwle were conducted in the first half of the year 2023. The analysis so far shows great interest in PF, although the term is mostly unknown and experience seems to be limited. The respondents identified opportunities for participatory research, but also challenges that need to be overcome in terms of its implementation. Both groups emphasise the importance of PF, especially in the field of mental illness, and express ideas for its implementation.
Conclusions
The results will be incorporated into the structure of the advisory board, so that PF in the field of forensic psychiatry will be more successful and the exchange between researchers and pwle will be facilitated. Detailed results as well as impressions from the first meeting(s) of the advisory board will be presented at the EPA conference.
Critical CHD is associated with morbidity and mortality, worsened by delayed diagnosis. Paediatric residents are front-line clinicians, yet identification of congenital CHD remains challenging. Current exposure to cardiology is limited in paediatric resident education. We evaluated the impact of rapid cycle deliberate practice simulation on paediatric residents’ skills, knowledge, and perceived competence to recognise and manage infants with congenital CHD.
Methods:
We conducted a 6-month pilot study. Interns rotating in paediatric cardiology completed a case scenario assessment during weeks 1 and 4 and participated in paired simulations (traditional debrief and rapid cycle deliberate practice) in weeks 2–4. We assessed interns’ skills during the simulation using a checklist of “cannot miss” tasks. In week 4, they completed a retrospective pre-post knowledge-based survey. We analysed the data using summary statistics and mixed effect linear regression.
Results:
A total of 26 interns participated. There was a significant increase in case scenario assessment scores between weeks 1 and 4 (4, interquartile range 3–6 versus 8, interquartile range 6–10; p-value < 0.0001). The percentage of “cannot miss” tasks on the simulation checklist increased from weeks 2 to 3 (73% versus 83%, p-value 0.0263) and from weeks 2–4 (73% versus 92%, p-value 0.0025). The retrospective pre-post survey scores also increased (1.67, interquartile range 1.33–2.17 versus 3.83, interquartile range 3.17–4; p-value < 0.0001).
Conclusion:
Rapid cycle deliberate practice simulations resulted in improved recognition and initiation of treatment of simulated infants with congenital CHD among paediatric interns. Future studies will include full implementation of the curriculum and knowledge retention work.
To evaluate the economic costs of reducing the University of Virginia Hospital’s present “3-negative” policy, which continues methicillin-resistant Staphylococcus aureus (MRSA) contact precautions until patients receive 3 consecutive negative test results, to either 2 or 1 negative.
Design:
Cost-effective analysis.
Settings:
The University of Virginia Hospital.
Patients:
The study included data from 41,216 patients from 2015 to 2019.
Methods:
We developed a model for MRSA transmission in the University of Virginia Hospital, accounting for both environmental contamination and interactions between patients and providers, which were derived from electronic health record (EHR) data. The model was fit to MRSA incidence over the study period under the current 3-negative clearance policy. A counterfactual simulation was used to estimate outcomes and costs for 2- and 1-negative policies compared with the current 3-negative policy.
Results:
Our findings suggest that 2-negative and 1-negative policies would have led to 6 (95% CI, −30 to 44; P < .001) and 17 (95% CI, −23 to 59; −10.1% to 25.8%; P < .001) more MRSA cases, respectively, at the hospital over the study period. Overall, the 1-negative policy has statistically significantly lower costs ($628,452; 95% CI, $513,592–$752,148) annually (P < .001) in US dollars, inflation-adjusted for 2023) than the 2-negative policy ($687,946; 95% CI, $562,522–$812,662) and 3-negative ($702,823; 95% CI, $577,277–$846,605).
Conclusions:
A single negative MRSA nares PCR test may provide sufficient evidence to discontinue MRSA contact precautions, and it may be the most cost-effective option.
Exposure investigations are labor intensive and vulnerable to recall bias. We developed an algorithm to identify healthcare personnel (HCP) interactions from the electronic health record (EHR), and we evaluated its accuracy against conventional exposure investigations. The EHR algorithm identified every known transmission and used ranking to produce a manageable contact list.
Central-line–associated bloodstream infection (CLABSI) surveillance in home infusion therapy is necessary to track efforts to reduce infections, but a standardized, validated, and feasible definition is lacking. We tested the validity of a home-infusion CLABSI surveillance definition and the feasibility and acceptability of its implementation.
Design:
Mixed-methods study including validation of CLABSI cases and semistructured interviews with staff applying these approaches.
Setting:
This study was conducted in 5 large home-infusion agencies in a CLABSI prevention collaborative across 14 states and the District of Columbia.
From May 2021 to May 2022, agencies implemented a home-infusion CLABSI surveillance definition, using 3 approaches to secondary bloodstream infections (BSIs): National Healthcare Safety Program (NHSN) criteria, modified NHSN criteria (only applying the 4 most common NHSN-defined secondary BSIs), and all home-infusion–onset bacteremia (HiOB). Data on all positive blood cultures were sent to an infection preventionist for validation. Surveillance staff underwent semistructured interviews focused on their perceptions of the definition 1 and 3–4 months after implementation.
Results:
Interrater reliability scores overall ranged from κ = 0.65 for the modified NHSN criteria to κ = 0.68 for the NHSN criteria to κ = 0.72 for the HiOB criteria. For the NHSN criteria, the agency-determined rate was 0.21 per 1,000 central-line (CL) days, and the validator-determined rate was 0.20 per 1,000 CL days. Overall, implementing a standardized definition was thought to be a positive change that would be generalizable and feasible though time-consuming and labor intensive.
Conclusions:
The home-infusion CLABSI surveillance definition was valid and feasible to implement.
Access to patient information may affect how home-infusion surveillance staff identify central-line–associated bloodstream infections (CLABSIs). We characterized information hazards in home-infusion CLABSI surveillance and identified possible strategies to mitigate information hazards.
Design:
Qualitative study using semistructured interviews.
Setting and participants:
The study included 21 clinical staff members involved in CLABSI surveillance at 5 large home-infusion agencies covering 13 states and the District of Columbia. Methods: Interviews were conducted by 1 researcher. Transcripts were coded by 2 researchers; consensus was reached by discussion.
Results:
Data revealed the following barriers: information overload, information underload, information scatter, information conflict, and erroneous information. Respondents identified 5 strategies to mitigate information chaos: (1) engage information technology in developing reports; (2) develop streamlined processes for acquiring and sharing data among staff; (3) enable staff access to hospital electronic health records; (4) use a single, validated, home-infusion CLABSI surveillance definition; and (5) develop relationships between home-infusion surveillance staff and inpatient healthcare workers.
Conclusions:
Information chaos occurs in home-infusion CLABSI surveillance and may affect the development of accurate CLABSI rates in home-infusion therapy. Implementing strategies to minimize information chaos will enhance intra- and interteam collaborations in addition to improving patient-related outcomes.
Adolescents with depression need access to culturally relevant psychological treatment. In many low- and middle-income countries treatments are only accessible to a minority. We adapted group interpersonal therapy (IPT) for adolescents to be delivered through schools in Nepal. Here we report IPT's feasibility, acceptability, and cost.
Methods
We recruited 32 boys and 30 girls (aged 13–19) who screened positive for depression. IPT comprised of two individual and 12 group sessions facilitated by nurses or lay workers. Using a pre-post design we assessed adolescents at baseline, post-treatment (0–2 weeks after IPT), and follow-up (8–10 weeks after IPT). We measured depressive symptoms with the Depression Self-Rating Scale (DSRS), and functional impairment with a local tool. To assess intervention fidelity supervisors rated facilitators' IPT skills across 27/90 sessions using a standardised checklist. We conducted qualitative interviews with 16 adolescents and six facilitators post-intervention, and an activity-based cost analysis from the provider perspective.
Results
Adolescents attended 82.3% (standard deviation 18.9) of group sessions. All were followed up. Depression and functional impairment improved between baseline and follow-up: DSRS score decreased by 81% (95% confidence interval 70–95); functional impairment decreased by 288% (249–351). In total, 95.3% of facilitator IPT skills were rated superior/satisfactory. Adolescents found the intervention useful and acceptable, although some had concerns about privacy in schools. The estimate of intervention unit cost was US $96.9 with facilitators operating at capacity.
Conclusions
School-based group IPT is feasible and acceptable in Nepal. Findings support progression to a randomised controlled trial to assess effectiveness and cost-effectiveness.
Background: A phase 3 trial, ADVANCE (NCT03777059), demonstrated that atogepant, an oral, CGRP receptor antagonist dosed once daily, results in clinically meaningful reductions in mean monthly migraine days. This open-label extension for ADVANCE trial completers evaluated long-term safety and tolerability of atogepant over 40-weeks. Methods: Participants in this trial (NCT03939312), rolled over from the ADVANCE trial, were treated with atogepant 60mg once daily for 40-weeks, with a 4-week safety follow-up. Only safety data were collected. Results: 685 participants took at least one dose of study drug, 74.6% completed the 40-week treatment period; mean age of 41.8 years, 88.2% female, 84.4% white, and mean BMI of 30.58 kg/m2. Mean (SD) treatment duration was 233.6 (89.32) days. 62.5% of participants experienced a treatment-emergent adverse event (TEAE), with 8.8% considered treatment-related by the investigator; serious adverse events (SAEs) occurred in 3.4% of participants, none were treatment-related. The most frequent AEs leading to discontinuation was nausea (0.4%, n=3); the most frequent TEAEs observed included upper respiratory tract infection (5.5%, n=38) and urinary tract infection (5.3%, n=36). No deaths or hepatic safety issues were observed. Conclusions: Safety results are consistent with known safety profile of atogepant and support long-term safety and tolerability of once daily dosing of atogepant 60mg.
Background: Duchenne muscular dystrophy (DMD) is a severe progressive neuromuscular disease. This study aimed to estimate the prevalence, healthcare resource utilization (HRU), and medical costs of DMD in Alberta. Methods: This retrospective study linked provincial healthcare administrative data to identify patients with DMD utilizing a modified diagnostic code algorithm, including males <30 years of age. Five-year (April 2012 to March 2017) prevalence estimates were calculated and all-cause direct HRU and costs were examined in the first-year post-diagnosis. Results: Overall, 111 patients (median age: 12.0 years (IQR 4.7-18.3)) with DMD were identified. The estimated five-year period prevalence was 35.72 (95% CI 31.88-39.91) per 100,000 persons. All-cause HRU in the first-year post-diagnosis included a mean (SD) of 0.48 (1.19) hospitalizations (length of stay: 9.37 days (36.47)), 3.96 (6.16) general practitioner visits, 28.52 (62.98) specialist visits, and 20.14 (16.49) ambulatory care visits. Mean (SD) all-cause direct costs were $18,868 ($29,206) CAD in the first-year post-diagnosis. Conclusions: Patients with DMD had multiple interactions with the healthcare system in the year following diagnosis, resulting in substantial direct medical costs. More effective treatment strategies are needed to improve health outcomes and reduce the burden of DMD.
Using the field–particle correlation technique, we examine the particle energization in a three-dimensional (one spatial dimension and two velocity dimensions; 1D-2V) continuum Vlasov–Maxwell simulation of a perpendicular magnetized collisionless shock. The combination of the field–particle correlation technique with the high-fidelity representation of the particle distribution function provided by a direct discretization of the Vlasov equation allows us to ascertain the details of the exchange of energy between the electromagnetic fields and the particles in phase space. We identify the velocity-space signatures of shock-drift acceleration of the ions and adiabatic heating of the electrons arising from the perpendicular collisionless shock by constructing a simplified model with the minimum ingredients necessary to produce the observed energization signatures in the self-consistent Vlasov–Maxwell simulation. We are thus able to completely characterize the energy transfer in the perpendicular collisionless shock considered here and provide predictions for the application of the field–particle correlation technique to spacecraft measurements of collisionless shocks.
To evaluate the role of procalcitonin (PCT) results in antibiotic decisions for COVID-19 patients at hospital presentation.
Design, setting, and participants:
Multicenter retrospective observational study of patients ≥18 years hospitalized due to COVID-19 at the Johns Hopkins Health system. Patients who were transferred from another facility with >24 hours stay and patients who died within 48 hours of hospitalization were excluded.
Methods:
Elevated PCT values were determined based on each hospital’s definition. Antibiotic therapy and PCT results were evaluated for patients with no evidence of bacterial community-acquired pneumonia (bCAP) and patients with confirmed, probable, or possible bCAP. The added value of PCT testing to clinical criteria in detecting bCAP was evaluated using receiving operating curve characteristics (ROC).
Results:
Of 962 patients, 611 (64%) received a PCT test. ROC curves for clinical criteria and clinical criteria plus PCT test were similar (at 0.5 ng/mL and 0.25 ng/mL). By bCAP group, median initial PCT values were 0.58 ng/mL (interquartile range [IQR], 0.24–1.14), 0.23 ng/mL (IQR, 0.1–0.63), and 0.15 ng/mL (IQR, 0.09–0.35) for proven/probable, possible, and no bCAP groups, respectively. Among patients without bCAP, an elevated PCT level was associated with 1.8 additional days of CAP therapy (95% CI, 1.01–2.75; P < .01) compared to patients with a negative PCT result after adjusting for potential confounders. Duration of CAP therapy was similar between patients without a PCT test ordered and a low PCT level for no bCAP and possible bCAP groups.
Conclusions:
PCT results may be abnormal in COVID-19 patients without bCAP and may result in receipt of unnecessary antibiotics.
Attempts to reduce high utilisation of psychiatric inpatient care by targeting the critical time of hospital discharge have been rare. In Germany, until now no such intervention has been implemented, let alone subjected to a clinical trial.
Method
“Effectiveness and Cost-Effectiveness of Needs-Oriented Discharge Planning and Monitoring for High Utilisers of Psychiatric Services” (NODPAM) is a multicentre RCT conducted in five psychiatric hospitals in Germany (Günzburg, Düsseldorf, Regensburg, Greifswald, and Ravensburg). Subjects asked to provide informed consent to participate have to be of adult age with a primary diagnosis of schizophrenia or affective disorder, and a defined high utilisation of psychiatric care during two years prior to the current admission. Subjects are asked to provide detailed outcome data at four measurement points during a period of 18 months. Recruitment (which started in April 06) is still ongoing. Thus, baseline data of about 350 participants will be presented.
Results
Recruitment has been quite successful and the study has been generally well accepted by participating patients and their clinicians in in- and outpatient treatment settings. Subjects showed substantial initial impairment on outcome measures (e.g. needs, psychopathology, quality of life, and level of functioning) and high utilisation of mental health care. Further results on conduct and feasibility of the trial will be presented.
Conclusions
The first phase of this mulicentre trial was promising. The potential of this study to strengthen the integration of mental health care provision in Germany will be discussed.
Aim of this contribution is to describe the intervention used in the study “Effectiveness and Cost-Effectiveness of Needs-Oriented Discharge Planning and Monitoring for High Utilisers of Psychiatric Services” (NODPAM). This intervention applies principles of needs-led care and focusses on the inpatient-outpatient transition. The NODPAM intervention manual includes a range of predefined standardised options based on number and type of needs.
Method
For the intervention group, a trained intervention worker provides a coherent package of needs-oriented discharge planning and monitoring focussing on the care process. He or she emphasises continuity of the care process vis-à-vis both patient and clinician (and carers if possible) via providing two manualised intervention sessions): (a) A discharge planning session takes place just before discharge with the patient and responsible clinician at the inpatient service; (b) A monitoring session takes place three months after discharge with the patient and outpatient clinician (office-based or public outpatient mental health service-based). A written treatment plan is signed by and forwarded to all participants after each session.
Results
Acceptance of the intervention by patients and clinicians has been high so far. Further results on duration, participant characteristics, and participants' appraisal of the NODPAM intervention will be presented.
Conclusion
These first results indicate that the NODPAM intervention is feasible in inpatient mental health services in Germany. Discussion will focus on its applicability in other service systems.
Borderline personality disorder (BPD) is characterized by pervasive instability in moods, interpersonal relationships, self-image, and behavior. This disorder is associated with a significant rate of suicide attempts and completed suicides (4 to 10%), a major impairment in social functioning and an increased healthcare utilization cost. Treatments available include psychotherapy and pharmacotherapy. Research has shown some efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) on post-traumatic stress disorder and mood disorder which both share common biological or clinical features with BPD. It is then likely that rTMS might prove efficient on BPD symptoms.
A review of the literature on neuroimaging and neuropsychology of BPD shows a hypoactivity of the dorsolateral prefrontal cortex which may be a potential target site for rTMS.
We will conduct a pilot randomized sham-controlled trial on 30 BPD patients assessing the efficacy of a 10-day course of daily rTMS on neuropsychological tasks, BPD symptoms severity, risk taking behaviour, depression and general psychopathology.