Routine Setting Research Articles

An exploration of multi-level factors affecting routine linkage to HIV care in Zambia's PEPFAR-supported treatment program in the treat all era.

Multiple steps from HIV diagnosis to treatment initiation and confirmed engagement with the health system are required for people living with HIV to establish full linkage to care in the modern treat all era. We undertook a qualitative study to gain an in-depth understanding of the impeding and enabling factors at each step of this linkage pathway. In-depth interviews were conducted with fifty-eight people living with HIV recruited from ten routine HIV care settings supported by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR) in Lusaka, Zambia. Using a semi-structured interview guide informed by an established conceptual framework for linkage to care, questions explored the reasons behind late, missed, and early linkage into HIV treatment, as well as factors influencing the decision to silently transfer to a different clinic after an HIV diagnosis. We identified previously established and intersecting barriers of internal and external HIV-related stigma, concerns about ART side effects, substance use, uncertainties for the future, and a perceived lack of partner and social support that impeded linkage to care at every step of the linkage pathway. However, we also uncovered newer themes specific to the current test and treat era related to the rapidity of ART initiation and insufficient patient-centered post-test counseling that appeared to exacerbate these well-known barriers, including callous health workers and limited time to process a new HIV diagnosis before treatment. Long travel distance to the clinic where they were diagnosed was the most common reason for silently transferring to another clinic for treatment. On the other hand, individual resilience, quality counseling, patient-centered health workers, and a supportive and empathetic social network mitigated these barriers. These findings highlight potential areas for strengthening linkage to care and addressing early treatment interruption and silent transfer in the test and treat era in Zambia.

Parenting for Lifelong Health for Young Children in Montenegro: Preliminary Outcomes, Dissemination, and Broader Embedding of the Program

The quality of parenting program implementation significantly affects the extent to which a program is delivered effectively as well as the likelihood of it becoming embedded in everyday services. The group based Parenting for Lifelong Health for Young Children (PLH-YC) program for parents of children aged 2–9 years was developed specifically for implementation in low- and middle-income contexts, has been tested in five randomized trials, and incorporates a number of strategies to encourage fidelity of delivery. This paper reports on the introduction of PLH-YC to Montenegro, including initial work to engage government agencies and service providers, adapt the program and, following initial evidence of effectiveness, implement strategies to promote effective delivery and embed the program. Following program adaptation and initial facilitator training, eight groups were run, supported with resources and supervision and independently evaluated. The successful pilot led to program training accreditation by national professional agencies and a series of steps to successfully further embed it into routine settings in Montenegro, including by recognizing the program in national policy documents. This led to further facilitator trainings, now numbering 97 facilitators and the certification of ten coaches and two trainers. By the end of 2023, 1278 parents, across 13 municipalities (half of all municipalities in Montenegro) and a range of service providers, have received the program. The paper describes the project phases and key fidelity components that underpinned the successful introduction and embedding of the program in Montenegro. The plan has resulted in Montenegro having its own domestic resources to continue to implement the program effectively and further plan for widespread dissemination.

Clinical and economic burden of organ damage among patients with systemic lupus erythematosus in a real-world setting in Germany

BackgroundSystemic lupus erythematosus (SLE), a chronic multisystem autoimmune disease, carries high risk of organ damage and burden to healthcare systems. SLE disease modification aims to reduce disease activity with minimal treatment toxicity and preventing or minimizing organ damage development. This real-world study utilizing healthcare administrative claims data assessed organ damage development, associated costs and healthcare resource utilization (HCRU) in patients with SLE in Germany.MethodsClaims data from January 1, 2007, to December 31, 2017, were obtained from the Betriebskrankenkassen German Sickness Fund Database. Adults (> 18 years) with a confirmed SLE diagnosis between January 1, 2009, and December 31, 2014, (inclusion period) were included. The index date was calculated based on the first recorded SLE diagnosis during this period. Patients were propensity score–matched (1:3) to a comparator cohort without SLE by age, sex, and comorbidities (Charlson comorbidity index). Organ damage was identified using an algorithm developed based on conditions described in the Systemic Lupus International Collaborating Clinics/American College of Rheumatology Damage Index (SDI), using ICD-10-GM diagnostic codes, healthcare procedures, and/or treatments.Results2121 patients with SLE and 6308 comparator patients were included (mean follow-up time: 6.4 years). Organ damage prevalence increased from 60.5% at baseline to 83.0% during 6 years of follow-up in all patients with SLE, while 17.0% of patients with SLE did not develop organ damage. Patients with newly confirmed SLE diagnosis without organ damage at baseline were nearly twice as likely to develop organ damage within 5 years versus the comparator cohort (52.0% vs. 27.0%). Total annual costs per patient-year for patients with SLE with organ damage were more than double those of patients with SLE without organ damage; both the number of inpatient admissions and length of stay were higher.ConclusionsThe application of a recently developed algorithm allowed us to use claims data to elucidate SLE organ damage, and its associated high clinical and economic burden, in a large, representative sample in Germany. To our knowledge, this is the first European analysis of its kind involving a broad cohort of patients with SLE treated in the routine care setting.

Assessment of Cefuroxime and Cefuroxime Clavulanic Acid Prescription Practices for Infection Management in Routine Indian Healthcare Settings: Expert Insights

Background: Cefuroxime axetil has shown effectiveness as part of intravenous/oral sequential therapy for community-acquired pneumonia (CAP) treatment, although some countries currently lack dosage recommendations for this regimen. In addition, the perspectives of clinicians were not studied. So, this study evaluated the prescription practice of cefuroxime, and cefuroxime+ clavulanic acid in the management of infections in routine Indian settings. Methods: The cross-sectional survey, titled ‘Cefuroxime & Cefuroxime+Clavulanic acid in Management of Infections: Expert Perspective (CARE) Study’, utilized a 20-item, multiple-response questionnaire to gather expert opinion from specialists regarding the clinical use of cefuroxime and cefuroxime + clavulanic acid in managing infections. The survey encompassed questions about current prescription practices, clinical observations, preferences, and experiences related to the use of these antibiotics in routine settings. Results: Among the 164 clinicians surveyed, 78% of the respondents indicated that cefuroxime was highly effective in managing lower respiratory tract infections. Additionally, 91% of the experts stated that the combination of cefuroxime and clavulanic acid was very effective in managing infections. The majority of clinicians recommended cefuroxime + clavulanic acid as the initial therapy for complicated urinary tract infections (88%), as well as first-line therapy for uncomplicated skin and soft tissue infections (45%) and community-acquired pneumonia (58%). According to 40% of the clinicians, cefuroxime + clavulanic acid was recommended as the initial therapy for 21-30% of patients suspected of methicillin-resistant Staphylococcus aureus infection. Most respondents (88%) preferred cefuroxime + clavulanic acid as the antibiotic for managing Pseudomonas aeruginosa infection. Conclusion: The survey has emphasized the critical role of cefuroxime and cefuroxime + clavulanic acid as antibiotics in managing diverse infections. Clinicians' recognition of their efficacy and preference for combination therapy has underscored the importance of antibiotic stewardship in optimizing patient care.

Effectiveness of double-dose dolutegravir in people receiving rifampin-based tuberculosis treatment: an observational, cohort study of people with HIV from six countries.

Tenofovir-lamivudine-dolutegravir (TLD) is the preferred first-line antiretroviral therapy (ART) regimen. An additional 50 mg dose of dolutegravir (TLD + 50) is required with rifampin-containing tuberculosis (TB) co-treatment. There are limited data on the effectiveness of TLD + 50 in individuals with TB/HIV. Prospective, observational cohort study at 12 sites in Haiti, Kenya, Malawi, South Africa, Uganda, Zimbabwe. Participants starting TLD and rifampin-containing TB treatment were eligible. Primary outcome was HIV-1 RNA ≤1000 copies/mL at end of TB treatment. We enrolled 91 participants with TB/HIV: 75 (82%) ART-naïve participants starting TLD after a median 15 days on TB treatment, 10 (11%) ART-naïve participants starting TLD and TB treatment, 5 (5%) starting TB treatment after a median 3.3 years on TLD, and 1 (1%) starting TB treatment and TLD after changing from efavirenz/lamivudine/tenofovir. Median age was 37 years, 35% female, median CD4 count 120 cells/mm3 (IQR 50-295), 87% had HIV-1 RNA >1000 copies/mL. Two participants died during TB treatment. Among 89 surviving participants, 80 were followed to TB treatment completion, including 7 who had no HIV-1 RNA result due to missed visits. Primary virologic outcome was assessed in 73 participants, of whom 69 (95%, 95% CI 89-100%) had HIV-1 RNA ≤1000 copies/mL. No dolutegravir resistance mutations were detected among four participants with HIV-1 RNA >1000 copies/mL. In routine programmatic settings, concurrent rifampin-containing TB treatment and TLD + 50 was feasible, well-tolerated, and achieved high rates of viral suppression in a cohort of predominantly ART-naïve people with TB/HIV.

Evaluation of a real-time PCR assay performance to detect Mycobacterium tuberculosis, rifampicin, and isoniazid resistance in sputum specimens: a multicenter study in two major cities of Indonesia.

Tuberculosis (TB) is one of the major global health issues due to its high mortality rate, especially in low- and middle-income countries. One of the key success points of the TB eradication program is early TB diagnosis, which requires rapid and accurate diagnostic testing. This study aimed to evaluate the performance of a newly developed RT-PCR kit (Indigen MTB/DR-TB RT-PCR) in a routine TB clinical setting. A multi-fluorescence RT-PCR assay was designed and developed to detect regions within IS6110, rpoB, katG, and inhA of the Mycobacterium tuberculosis (MTB) genes. Sputum specimens were obtained from suspected TB patients who visited TB healthcare facilities in two major cities of Indonesia from September 2022 to May 2023. Specimens were assessed using Indigen MTB/DR-TB RT-PCR, acid-fast bacillus (AFB) smear microscopy, MTB culture, and drug susceptibility testing (DST) methods. Fisher's exact test (χ2) was used to analyze the Indigen performance relative to culture methods. The performance of Indigen MTB/DR-TB RT-PCR to detect MTB was assessed using 610 sputum specimens obtained from suspected patients. The overall sensitivity and specificity were 94.12% (95% CI: 90.86-96.48%) and 98.32% (95% CI: 96.20-99.46%), respectively. When the analysis was performed on AFB smear-negative TB subjects (386 subjects), a lower sensitivity level was found at 78.57% (95% CI: 68.26-86.78%), while the specificity level remained similar at 98.34% (95% CI: 96.18-99.46%). The overall performance of Indigen MTB/DR-TB RT-PCR to detect MTB showed substantial agreement with the MTB culture method (kappa value 0.93). In comparison to DST, the sensitivity and specificity levels of Indigen to detect RIF resistance or INH resistance were 78.2% (95% CI: 61.8-90.2%) and 82.8% (95% CI: 64.2-94.2%), respectively, while the specificity level for both groups was at 100% (95% CI, 87.7-100%). Indigen MTB/DR-TB RT-PCR demonstrated reliable performance for TB molecular diagnostic testing and can be implemented in routine TB diagnostic settings.

Risk Prediction Models for Renal Function Decline After Cardiac Surgery Within Different Preoperative Glomerular Filtration Rate Strata.

Our goal was to create a simple risk-prediction model for renal function decline after cardiac surgery to help focus renal follow-up efforts on patients most likely to benefit. This single-center retrospective cohort study enrolled 24 904 patients who underwent cardiac surgery from 2012 to 2019 at Fuwai Hospital, Beijing, China. An estimated glomerular filtration rate (eGFR) reduction of ≥30% 3 months after surgery was considered evidence of renal function decline. Relative to patients with eGFR 60 to 89 mL/min per 1.73 m2 (4.5% [531/11733]), those with eGFR ≥90 mL/min per 1.73 m2 (10.9% [1200/11042]) had a higher risk of renal function decline, whereas those with eGFR ≤59 mL/min per 1.73 m2 (5.8% [124/2129]) did not. Each eGFR stratum had a different strongest contributor to renal function decline: increased baseline eGFR levels for patients with eGFR ≥90 mL/min per 1.73 m2, transfusion of any blood type for patients with eGFR 60 to 89 mL/min per 1.73 m2, and no recovery of renal function at discharge for patients with eGFR ≤59 mL/min per 1.73 m2. Different nomograms were established for the different eGFR strata, which yielded a corrected C-index value of 0.752 for eGFR ≥90 mL/min per 1.73 m2, 0.725 for eGFR 60-89 mL/min per 1.73 m2 and 0.791 for eGFR ≤59 mL/min per 1.73 m2. Predictors of renal function decline over the follow-up showed marked differences across the eGFR strata. The nomograms incorporated a small number of variables that are readily available in the routine cardiac surgical setting and can be used to predict renal function decline in patients stratified by baseline eGFR.

Silver Diamine Fluoride Use in Children with Special Health-care Needs: Breaking the Barriers

Dental caries is the most common unmet dental need of children with special health-care needs (SHCNs), and their treatment is challenging in routine dental settings. Based on surplus evidence, silver diamine fluoride (SDF) is a simple, safe, cost-effective, and efficient topical solution for treating dental caries. It is a clear, colorless, odorless fluoride-containing solution, does not require an extensive armamentarium for its application, and can be used in any setting. However, even with worldwide acceptance, there occurs limited research regarding SDF use in children with special needs. This review aims to update the possibilities and acceptability of SDF usage in patients with special needs with dental caries as a promising option for managing dental caries and improving their quality of life.

Accuracy, use and acceptability of the VISITECT CD4 semi-quantitative test to advance HIV disease screening in routine programmatic settings in Tanzania

BackgroundThe available few laboratory-based CD4 assay for People Living with HIV (PLHIV) experience supply stock-outs and instrument breakdowns in developing countries, affecting the ability to diagnose Advance HIV disease (AHD). We evaluated the performance of the VISITECT CD4 point of care test among healthcare workers in HIV program in Tanzania. MethodsA retrospective diagnostic accuracy study was conducted among PLHIV who received both the VISITECT CD4 and a standard-of-care. Acceptability of the VISITECT CD4 by healthcare workers was assessed using a structured questionnaire. Both FACS Count and Pima CD4 assay were considered as reference standards. Findings were summarized as proportions with 95 % confidence intervals (CI). Data were analyzed using STATA 17 (StataCorp, College Station, TX). ResultsA total of 1370 PLHIV were tested using VISITECT CD4 across 20 facilities between 3 April and 14 September 2022. The median age was 37 (Interquartile range (IQR):29–46). Overall, 897 (65.5 %) were females and 449 had both VISITECT CD4 test and standard of care. The sensitivity and specificity were; 95.9 % (95 % CI: 91.8 %–98.3 %) and 78.3 % (95 % CI: 73.0 %–83.0 %) respectively. 47 healthcare workers used the VISITECT CD4, of whom 57.5 % were non-laboratory healthcare workers. Majority of the healthcare workers were of the opinion that the training was adequate and VISITECT CD4 was easy and useful in clinical decisions. ConclusionThe VISITECT CD4 test was accurate, useable and acceptable among healthcare workers in Tanzania. The scale up of VISITECT CD4 should consider development of training curriculum and the use of job aids particularly for non-laboratory healthcare workers.

P063 Beyond the clinical trials: real-world retention rate and use of digital interventions in patients with inflammatory arthritis

Abstract Background/Aims The use of digital tools to deliver healthcare interventions has increased rapidly. Inadequate engagement and retention are two major barriers to widespread and long-term adoption of electronic patient-reported outcomes (ePROs) for monitoring in clinical practice. Whilst retention rates are high in research studies, these are often short-term (<12months) and not representative of routine clinical practice. The reasons for variable engagement remain unclear. We present an analysis of engagement and retention of digital intervention in a routine rheumatology setting. The research aims to explore determinants of long-term sustainability of app-based intervention to collect ePROs in patients with inflammatory arthritis (IA). Methods This is a secondary analysis of real-world data obtained in clinical settings from IA patients who attended routine appointments in the rheumatology clinic at North Bristol NHS Trust between 2018 and 2022. Patients were invited to use a smartphone-based symptom diary (Living With) between appointments to track disease course by reporting RAPID3, HAQ-DI, or self-assessing joint pain/swelling. Statistical tests were performed using Stata16.1. Maximum elapsed days of the app use, number, and time between reports were explored as explanatory variables. Associations between demographic and disease parameters in different user subpopulations were explored by Poisson and tobit regression models. Results were stratified post-hoc by gender, age, diagnosis, and baseline disease activity. The research has ethical approval. Results 673 patients provided ≥1 report of any ePROs. 68% were female, mean age 53.7±13.9 years. 60% had rheumatoid arthritis; 24% - psoriatic arthritis and 17% - other IA. 613(91%) patients provided a RAPID3 measure of disease activity. Among them, 82(12%) participants reported only baseline RAPID3 and were classified as “lost to follow-up”. 531(79%) were identified as “follow-up” users. No difference between these subpopulations considering gender, age, IA type, and baseline arthritis activity was identified in the adjusted Poisson regression model. Retention rates reduced most in the first six months from a baseline of 91% to 38% at month 6 and subsequently to 24% at month 12, whereafter plateaued, highlighting a group of long-term users. Older patients (aged 60-69) were more likely to be long-term users compared to younger age (≤50) participants, demonstrating longer app engagement 379 [169; 645] vs 256 [90; 515] days, p < 0.006. Patients aged 60-69 and ≥70 provided more reports (18 [7; 46] and 25 [8; 62]) compared to younger users (8 [4;18], p < 0.0001). There was no association between the length or frequency of digital tool use and gender, baseline arthritis activity, and disability. Conclusion This analysis offers insights into what might be expected regarding engagement and the long-term sustainability of app-based interventions in routine clinical settings. Understanding the real-world performance and factors that could potentially improve user retention or dropout rates is critical to realizing the promise of digital interventions. Disclosure I. Biliavska: None. E. Lenguerrand: None. J. Tobias: None. P. Hamann: Consultancies; provided consultancy for Living With Ltd Software Company. Royalties; has limited royalty agreement with Living With Ltd Software Company for the development of the smartphone app LivingWith. Honoraria; have received honoraria from Gilead and AbbVie Pharmaceuticals for the production of training materials on remote monitoring for patients with arthritis..

Mental capacity assessment in the multi-professional real world: a qualitative study of six areas of uncertainty.

The Mental Capacity Act 2005 of England and Wales is a ground-breaking piece of legislation with reach into healthcare, social care and legal settings. Professionals have needed to develop skills to assess mental capacity and handle malign influence, but it is unclear how assessments are implemented in real world settings. Our previously reported survey found professionals juggling competing resources in complex systems, often struggling to stay up to date with law.The current follow-up study uses one-to-one interviews of professionals to characterise in detail six areas of uncertainty faced when assessing mental capacity, whilst suggesting ways to make improvements. Forty-four healthcare, social care and legal professionals were interviewed, using a semi-structured topic guide. Transcripts were analysed using framework analysis: a qualitative technique built to investigate healthcare policy. Our topic guide generated 21 themes. In relation to the six areas of uncertainty: 1) Many participants stressed the importance of capturing a holistic view, adding that their own profession was best-placed for this - although a medical diagnosis was often needed. 2) The presumption of capacity was a laudable aim, though not always easy to operationalise and occasionally being open to abuse. 3) There was cautious interest in psychometric testing, providing a cognitive context for decisions. 4) Undue influence was infrequent, but remained under-emphasised in training. 5) Multi-professional assessments were common, despite doubts about fitting these within local resources and the law. 6) Remote assessment was generally acceptable, if inadequate for identifying coercion. Practical constraints and competing demands were reported by professionals working within real world systems. Assessment processes must be versatile, equally applicable in routine and emergency settings, across diverse decisional types, for both generalist and specialist assessors, and able to handle coercion. Recognising these challenges will guide development of best practices in assessment and associated policy.

Advanced optical photothermal infrared spectroscopy for comprehensive characterization of microplastics from intravenous fluid delivery systems

Growing attention is being directed towards exploring the potential harmful effects of microplastic (MP) particles on human health. Previous reports on human exposure to MPs have primarily focused on inhalation, ingestion, transdermal routes, and, potentially, transplacental transfer. The intravenous transfer of MP particles in routine healthcare settings has received limited exploration in existing literature. Standard hospital IV system set up with 0.9 % NaCl in a laminar flow hood with MP contamination precautions. Various volumes of 0.9 % NaCl passed through the system, some with a volumetric pump. Fluid filtered with Anodisc filters washed with isopropyl alcohol. The IV cannula was immersed in Mili-Q water for 72 h to simulate vein conditions. Subsequently, the water was filtered and washed. Optical photothermal infrared (O-PTIR) microspectroscopy is used to examine filters for MP particles. All filters examined from the IV infusion system contained MP particles, including MPs from the polymer materials used in the manufacture of the IV delivery systems (polydimethylsiloxane, polypropylene, polystyrene, and polyvinyl chloride) and MP particles arising from plastic resin additives (epoxy resin, polyamide resin, and polysiloxane-containing MPs). The geometric mean from the extrapolated result data indicated that approximately 0.90 MP particles per mL of 0.9 % NaCl solution can be administered through a conventional IV infusion system in the absence of a volumetric pump. However, with the implementation of a pump, this value may increase to 1.57 particles per mL. Notably, over 72 h, a single cannula was found to release approximately 558 MP particles including polydimethylsiloxane, polysiloxane-containing MPs, polyamide resin, and epoxy resin. Routine IV infusion systems release microplastics. MP particles are also released around IV cannulas, suggesting transfer into the circulatory system during standard IV procedures.

Purine-Doped g-C3N4-Modified Fabrics for Personal Protective Masks with Rapid and Sustained Antibacterial Activity.

Protective masks are critical to impeding microorganism transmission but can propagate infection via pathogen buildup and face touching. To reduce this liability, we integrated electrospun photocatalytic graphitic carbon nitride (g-C3N4) nanoflakes into standard surgical masks to confer a self-sanitization capacity. By optimizing the purine/melamine precursor ratio during synthesis, we reduced the g-C3N4 band gap from 2.92 to 2.05 eV, eliciting a 4× increase in sterilizing hydrogen peroxide production under visible light. This narrower band gap enables robust photocatalytic generation of reactive oxygen species from environmental and breath humidity to swiftly eliminate accumulated microbes. Under ambient sunlight, the g-C3N4 nanocomposite mask layer achieved a 97% reduction in the bacterial viability during typical use. Because the optimized band gap also allows photocatalytic activity under shadowless lamp illumination, the self-cleaning functionality could mitigate infection risk from residual pathogens in routine hospital settings. Both g-C3N4 and polycaprolactone demonstrate favorable biocompatibility and biodegradability, making this approach preferable over current commercially available metal-based options. Given the abundance and low cost of these components, this scalable approach could expand global access to reusable self-sanitizing protective masks, serving as a sustainable public health preparedness measure against future pandemics, especially in resource-limited settings.

Long-Term Effectiveness of Cognitive Behavioral Therapy in Routine Outpatient Care for Youth with Anxiety Disorders

Introduction: This study examined the long-term effectiveness of cognitive behavioral therapy (CBT) (≥ 2 years after the end of therapy) in the routine care of youth (mean 11.95 years; SD = 3.04 years) with primary anxiety disorder (AD). Methods: Two hundred and ten children with any AD as a primary diagnosis and with any comorbidity were included in the “Kids Beating Anxiety (KibA)” clinical trial and received evidence-based CBT. Diagnoses, severity of diagnoses, and further dimensional outcome variables of symptoms and functioning were assessed before (baseline), after the last treatment session (POST), and at two follow-up (FU) assessments in the child and caregiver report: 6 months (6MONTHS-FU) and >2 years (mean 4.31; SD = 1.07 years) after the last treatment session (long-term FU). Results: At POST, 61.38% showed total remission of all and any ADs. At long-term FU, the remission rate was 63.64%. Compared to baseline, ratings of severity, anxiety, impairment/burden, and life quality improved significantly after CBT in child and caregiver report. All pre-post/FU improvements and global success ratings were stable in child (Pre-Post: Hedges’ g = 3.57; Pre-6MONTHS-FU: Hedges’ g = 3.43; Pre-LT-FU: Hedges’ g = 2.34) and caregiver report (Pre-Post: Hedges’ g = 2.00; Pre-6MONTHS-FU: Hedges’ g = 2.31; Pre-LT-FU: Hedges’ g = 2.31) across all POST- and FU-assessment points. Some outcomes showed further significant improvement, and no deterioration was found over the course of time. Effect sizes calculated in the present study correspond to, or even exceed, effect sizes reported in previous meta-analysis. Conclusions: Stable long-term effects of “KibA” CBT for youth with ADs, comparable to those results from efficacy studies, were achieved in a routine practice setting by applying treatment manuals tested in randomized controlled trials. These findings are remarkable, as the patient group studied here consisted of an age group within the main risk phase of developing further mental disorders, and therefore an increase in new-onset anxiety and further mental disorders would be expected over the long time span studied here.

Double-edged sword of corporate social responsibility (CSR) halo: the role of CSR efforts and crisis type and severity

ABSTRACT In recent years, the restaurant industry has been struggling with a variety of brand crises, including both product and moral harm crises. To mitigate the negative impact of such crises on their brands, companies are actively engaging in corporate social responsibility (CSR) initiatives. While a number of previous studies have investigated the influence of CSR on consumers’ responses to a brand in a routine setting, few have incorporated crisis-related situational variables into their examination of the role of CSR in a brand crisis situation. In order to test the extent to which the CSR halo plays a role in consumers’ evaluation in a brand crisis event, this study used a scenario-based 2 CSR efforts (low/high) x 2 crisis type (product harm/moral harm crisis) x 2 crisis severity (low/high) experimental design. The findings suggest that a higher level of brand engagement in CSR can offset the negative consequences of brand crisis in the case of product harm and less severe brand crisis, compared to moral harm and severe brand crisis, respectively. Our results provide valuable insights for companies wishing to respond successfully to a brand crisis event based on predicted consumers’ responses and on their CSR reputation.

Application of ‘Readiness for Change’ concept within implementation of evidence-based mental health interventions globally: protocol for a scoping review

Background Concerning the growing burden of mental illnesses globally, there has been an increased investment into the implementation of evidence-based mental health interventions (EBmhIs) in routine care settings. However, the uptake and implementation of these EBmhIs has faced challenges in the real-world context. Among the many barriers and facilitators of implementation of EBmhIs identified by implementation science frameworks, evidence on the role of readiness for change (RFC) remains sparse. RFC constitutes the willingness and perceived capacity of stakeholders across an organization to implement a new practice. Theoretically, RFC has been defined at organizational, group, and individual levels, however, its conceptualization and operationalization across all these levels have differed in studies on the implementation of EBmhIs. By conducting a scoping review, we aim to examine the literature on RFC within the implementation of EBmhIs. Methods This scoping review will be conducted following the PRISMA-ScR guidelines. Iterative review stages will include a systematic and comprehensive search through four electronic databases (PubMed, Web of Science, Embase, and PsycINFO), selecting studies, charting data, and synthesizing the results. English-language studies meeting the inclusion criteria will be screened independently by two reviewers. Discussion This review will synthesize knowledge on the conceptualization of RFC across organizational, group, and individual levels within the implementation of EBmhIs. In addition, it will identify how RFC has been measured in these studies and summarize the reported evidence on its impact on the implementation of EBmhIs. Conclusions This review will assist mental health researchers, implementation scientists, and mental health care providers to gain a better understanding of the state of research on RFC within the implementation of EBmhIs. Registration The final protocol was registered with the Open Science Framework on October 21, 2022 (https://osf.io/rs5n7).

Abstract LB381: Plasma microbiota as novel biomarkers of early epithelial ovarian cancer detection

Abstract Background: Ovarian cancer accounts for 2% of all female cancers in the United States yet it is the 5th leading cancer death among women. Advanced epithelial ovarian cancer (EOC) is associated with an overall survival rate of 30% but can be cured in up to 90% of cases if diagnosed early when the disease is still limited to the ovaries and fallopian tubes. While there is no effective screening method for EOC, developing novel and minimally invasive clinical tests is paramount to identify women with early disease as well as those who are at increased risk. Plasma-based microbiota signatures specific to EOC could become leading biomarkers of early disease in the field that complement existing clinical tools. Methods: We utilized an established institutional biobank to access 180 biobanked plasma samples from: (1) women with EOC; (2) women with non-EOC solid tumors; (3) women undergoing gynecologic-related procedures and non-EOC surgeries; and (4) healthy controls. Batch 1 included 96 plasma samples (n=24 per group) and Batch 2 included 84 samples (n=19 per group and 8 repeat EOC samples). Microbial profiles of plasma specimens were assessed using an amplicon-based sequencing method that targets the 16S rRNA gene in the bacterial genome to study bacterial phylogeny and taxonomy in diseased and healthy women. A stringent bioinformatic pipeline was applied to filter out suspicious bacterial contaminants at the genus level. Bacterial decontamination procedures in the pipeline included evaluating repeat plasma samples of EOC cases and sampling nucleic acid isolation kit reagents to serve as negative controls (only in Batch 2) . Differential abundances of the plasma microbiota among the groups were assessed using analysis of compositions of microbiomes (ANCOM) as implemented in R software package ANCOM-BC. Results: The 16S rRNA gene sequencing identified, classified, and quantified 564 bacterial genera in the circulation of women diagnosed with EOC, non-EOC solid tumors, benign gynecologic conditions, and healthy controls. Bioinformatic decontamination analysis removed bacteria: (1) with differing bacterial abundances between batches; (2) with higher bacteria in negative controls; (3) with differing bacterial abundances in repeat samples; and (4) known as contaminants in the literature that resulted in the removal of 225 high-risk bacterial contaminants. A total of 339 high quality bacteria remained for evaluation. Because we did not collect negative controls in Batch 1, only Batch 2 plasma samples (n=84; 27 in EOC group; 19 in each other group) were included in the final analysis. Women with EOC, which were primarily of the high-grade serous ovarian carcinoma histologic subtype had significantly distinct differential abundances of genera Brevibacterium (p <0.001), Chloronema (p <0.001), Facklamia (p <0.001), Zymomonas (p <0.001), and Sutterella (p <0.001) when compared to women with non-EOC solid tumors, benign gynecologic conditions, and healthy controls. Conclusions: These findings suggest that plasma EOC-associated bacteria could be exploited in the development of a microbial-based blood test for the diagnosis and early detection of EOC in routine practice settings. Citation Format: Diane E. Mahoney, Prabhakar Chalise, Dong Pei, Rachel Griffard, Trisha Home, Harsh Pathak, Shahid Umar, Andrew K. Godwin. Plasma microbiota as novel biomarkers of early epithelial ovarian cancer detection [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 2 (Late-Breaking, Clinical Trial, and Invited Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(7_Suppl):Abstract nr LB381.

Oncological and functional outcome after laryngectomy for laryngeal and hypopharyngeal cancer: a population-based analysis in Germany from 2001 to 2020

Prognostic factors for overall survival (OS), percutaneous endoscopic gastrostomy (PEG) dependency, and long-term speech rehabilitation via voice prosthesis (VP) after laryngectomy for laryngeal or hypopharyngeal cancer were investigated in a retrospective population-based study in Thuringia, Germany. A total of 617 patients (68.7% larynx; hypopharynx; 31.3%; 93.7% men; median age 62 years; 66.0% stage IV) from 2001 to 2020 were included. Kaplan–Meier and Cox multivariable regression analyses were performed. 23.7% of patients received a PEG. 74.7% received a VP. Median OS was 131 months. Independent factors for lower OS were stage IV (compared to stage II; hazard ratio [HR] = 3.455; confidence interval [CI] 1.395–8.556) and laryngectomy for a recurrent disease (HR = 1.550; CI 1.078–2.228). Median time to PEG removal was 7 months. Prior partial surgery before laryngectomy showed a tendency for independent association for later PEG removal (HR = 1.959; CI 0.921–4.167). Postoperative aspiration needing treatment was an independent risk factor (HR = 2.679; CI 1.001–7.167) for later definitive VP removal. Laryngectomy continuously plays an important role in a curative daily routine treatment setting of advanced laryngeal or hypopharyngeal cancer in Germany. Long-term dependency on nutrition via PEG is an important issue, whereas use of VP is a stable long-term measure for voice rehabilitation.

Electroencephalogram monitoring during ketamine antidepressant treatment: a pilot study

Introduction Depression is a major cause of disability world-wide. Up to a third of patients have a treatment-resistant form (TRD), presenting a major challenge. Ketamine has been introduced as a novel rapid-acting antidepressant effective in this population. However, at present, ketamine treatment is not routinely informed by any objective neural markers. Basic research has shown promising electroencephalogram (EEG) changes including a decrease in alpha power. However, clinical translation is lacking.ObjectivesAssess the feasibility of identifying EEG correlates of ketamine infusions in a routine outpatient setting with a low-cost, easily usable system.MethodsThe study was carried out at the Oxford Health Foundation Trust Ketamine Clinic (ethics reference 22/EM/0226). N=18 EEG recordings from N=12 patients were collected (5 women, mean age 44, range 33-62, IV dose 0.5-1mg/kg over 40min). 4-channel EEG was collected with a Muse-S headband at 256Hz, from 5min before to 55min after infusion start. 5s epochs were rejected if gyroscope data indicated head movement above 10 deg/s or if amplitude was above 200μV. A spectrogram (4s window, 3s overlap) as well as band-limited power (theta: 4-8Hz, alpha: 8-13Hz, beta: 13-25Hz) were computed. Significance of changes was found with a repeated measures analysis of variance (RM-ANOVA) on power in 5min segments together with post-hoc Tukey’s P-values.ResultsAcross the ketamine infusion recordings, there was a significant effect of time (F=3.65, P=0.0105) and Channel*Time interaction (F=3.80, P<0.001) on the EEG spectrum. Effects were largest on temporal electrodes, particularly TP9 in the alpha and theta bands (Figure 1, Table 1).Table 1:Effect sizes (Cohen’s d) and FDR-corrected ANOVA P-values for ketamine effects on each EEG channel and frequency band. P<0.05 was considered significant (bold). n.s. = not significant (P>0.2). Channel / Band TP9AF7AF8TP10Theta1.16 (P=0.019)0.11 (n.s.)0.11 (n.s.)0.42 (P=0.113)Alpha1.41 (P<0.001)0.12 (n.s.)0.17 (n.s.)0.605 (P=0.113)Beta1.19 (P=0.112)0.03 (n.s.)0.08 (n.s.)0.21 (n.s.)Image:ConclusionsIn a routine outpatient setting, sub-anaesthetic ketamine infusions in TRD patients were associated with decreased fronto-temporal EEG alpha and theta power. Future work should assess the potential of low-cost routine EEG, and alpha desaturation specifically, to inform individualised ketamine treatment.Disclosure of InterestNone Declared

Antenatal RHD screening to guide antenatal anti-D immunoprophylaxis in non-immunized D- pregnant women.

In pregnancy, D- pregnant women may be at risk of becoming immunized against D when carrying a D+ fetus, which may eventually lead to hemolytic disease of the fetus and newborn. Administrating antenatal and postnatal anti-D immunoglobulin prophylaxis decreases the risk of immunization substantially. Noninvasive fetal RHD genotyping, based on testing cell-free DNA extracted from maternal plasma, offers a reliable tool to predict the fetal RhD phenotype during pregnancy. Used as a screening program, antenatal RHD screening can guide the administration of antenatal prophylaxis in non-immunized D- pregnant women so that unnecessary prophylaxis is avoided in those women who carry a D- fetus. In Europe, antenatal RHD screening programs have been running since 2009, demonstrating high test accuracies and program feasibility. In this review, an overview is provided of current state-of-the-art antenatal RHD screening, which includes discussions on the rationale for its implementation, methodology, detection strategies, and test performance. The performance of antenatal RHD screening in a routine setting is characterized by high accuracy, with a high diagnostic sensitivity of ≥99.9 percent. The result of using antenatal RHD screening is that 97-99 percent of the women who carry a D- fetus avoid unnecessary prophylaxis. As such, this activity contributes to avoiding unnecessary treatment and saves valuable anti-D immunoglobulin, which has a shortage worldwide. The main challenges for a reliable noninvasive fetal RHD genotyping assay are low cell-free DNA levels, the genetics of the Rh blood group system, and choosing an appropriate detection strategy for an admixed population. In many parts of the world, however, the main challenge is to improve the basic care for D- pregnant women.