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Antibiotic exposure during immunotherapy (IO) has been shown to negatively affect clinical outcomes in various cancer types. The aim of this study was to evaluate whether antibiotic exposure in patients with high-risk early-stage HER2-negative breast cancer (BC) undergoing treatment with neoadjuvant pembrolizumab impacted residual cancer burden (RCB) and pathologic complete response (pCR) in the pembrolizumab-4 arm of the ISPY-2 clinical trial. Patients received pembrolizumab for four cycles concurrently with weekly paclitaxel for 12 weeks, followed by four cycles of doxorubicin plus cyclophosphamide every 2 or 3 weeks. Patients who received at least one dose of systemic antibiotics concurrently at the time of immunotherapy (IO) were included in the antibiotic exposure group (ATB+). All other participants were included in the control group (ATB-). RCB index and PCR rates were compared between the ATB+ and ATB- groups using t-tests and Chi-squared tests, and linear and logistic regression models, respectively. Sixty-six patients were included in the analysis. 18/66 (27%) patients were in the ATB+ group. Antibiotic use during IO was associated with a higher mean RCB index (1.80 ± 1.43 versus 1.08 ± 1.41) and a lower pCR rate (27.8% versus 52.1%). The association between antibiotic use and the RCB index remained significant in multivariable linear regression analysis (RCB index-coefficient 0.86, 95% CI 0.20-1.53, P = 0.01). Our findings suggest that concurrent antibiotic exposure during neoadjuvant pembrolizumab in HER2-negative early-stage BC is associated with higher RCB. Further validation in larger cohorts is needed to confirm these findings.

BackgroundLimited information is available for patients with breast cancer (BC) and coronavirus disease 2019 (COVID-19), especially among underrepresented racial/ethnic populations.MethodsThis is a COVID-19 and Cancer Consortium (CCC19) registry-based retrospective cohort study of females with active or history of BC and laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection diagnosed between March 2020 and June 2021 in the US. Primary outcome was COVID-19 severity measured on a five-level ordinal scale, including none of the following complications, hospitalization, intensive care unit admission, mechanical ventilation, and all-cause mortality. Multivariable ordinal logistic regression model identified characteristics associated with COVID-19 severity.Results1383 female patient records with BC and COVID-19 were included in the analysis, the median age was 61 years, and median follow-up was 90 days. Multivariable analysis revealed higher odds of COVID-19 severity for older age (aOR per decade, 1.48 [95% CI, 1.32-1.67]); Black patients (aOR 1.74; 95 CI 1.24-2.45), Asian Americans and Pacific Islander patients (aOR 3.40; 95 CI 1.70-6.79) and Other (aOR 2.97; 95 CI 1.71-5.17) racial/ethnic groups; worse ECOG performance status (ECOG PS ≥2: aOR, 7.78 [95% CI, 4.83-12.5]); pre-existing cardiovascular (aOR, 2.26 [95% CI, 1.63-3.15])/pulmonary comorbidities (aOR, 1.65 [95% CI, 1.20-2.29]); diabetes mellitus (aOR, 2.25 [95% CI, 1.66-3.04]); and active and progressing cancer (aOR, 12.5 [95% CI, 6.89-22.6]). Hispanic ethnicity, timing, and type of anti-cancer therapy modalities were not significantly associated with worse COVID-19 outcomes. The total all-cause mortality and hospitalization rate for the entire cohort was 9% and 37%, respectively however, it varied according to the BC disease status.ConclusionsUsing one of the largest registries on cancer and COVID-19, we identified patient and BC-related factors associated with worse COVID-19 outcomes. After adjusting for baseline characteristics, underrepresented racial/ethnic patients experienced worse outcomes compared to non-Hispanic White patients.FundingThis study was partly supported by National Cancer Institute grant number P30 CA068485 to Tianyi Sun, Sanjay Mishra, Benjamin French, Jeremy L Warner; P30-CA046592 to Christopher R Friese; P30 CA023100 for Rana R McKay; P30-CA054174 for Pankil K Shah and Dimpy P Shah; KL2 TR002646 for Pankil Shah and the American Cancer Society and Hope Foundation for Cancer Research (MRSG-16-152-01-CCE) and P30-CA054174 for Dimpy P Shah. REDCap is developed and supported by Vanderbilt Institute for Clinical and Translational Research grant support (UL1 TR000445 from NCATS/NIH). The funding sources had no role in the writing of the manuscript or the decision to submit it for publication.Clinical trial numberCCC19 registry is registered on ClinicalTrials.gov, NCT04354701.

Background: Existing evidence suggests that clinician and organization engagement in research can improve healthcare processes of care and outcomes. However, current evidence has considered the relationship across all healthcare professions collectively. With the increase in allied health clinical academic and research activity, it is imperative for healthcare organizations, leaders and managers to understand engagement in research within these specific clinical fields. This systematic review aims to identify the effect of engagement in research by allied health professionals (AHPs) and organizations on healthcare performance. Methods: This systematic review has a two-stage search strategy. The first stage will be to screen a previous systematic review examining the effectiveness of engagement in research in health and social care to identify relevant papers published pre-2012. The search strategy used in the previous review will then be rerun, but with a specific focus on allied health. This multi-database search will identify publications from 2012 to date. Only studies that assessed the effectiveness of allied health engagement in research will be included. All stages of the review will be conducted by two reviewers independently, plus documented discussions with the wider research team when discrepancies occur. This systematic review protocol follows the EQUATOR reporting guidelines of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses for Protocols (PRISMA-P). Discussion: The findings of this review will make a significant contribution to the evidence base around the effect of allied health engagement in research on healthcare performance. It will provide insights for clinicians and managers looking to understand the consequences of developing AHP research capability and capacity. The findings of this review will also aim to make recommendations for future evaluation approaches for engagement in research interventions.

Background Patients with multiple sclerosis (MS) may face barriers, such as treatment fatigue, memory problems, or side effects, that may influence their adherence to medication. Objective The objective of our study was to use an online community to develop a self-report questionnaire to quantify adherence and barriers to achieving adherence, that is specific to MS disease-modifying treatments (DMTs) and predictive of missed doses. Methods A review of the scientific literature and analysis of discussions between MS patients on PatientsLikeMe.com were used to generate survey items salient to patients. Cognitive debriefing was used to refine the items. The Multiple Sclerosis Treatment Adherence Questionnaire (MS-TAQ) contains 30 questions in three subscales: Barriers, Side Effects, and Coping Strategies. Results MS patients completed an online survey (response rate: 431 of 1209 invited, 35.7%). Between 16% (14/86) and 51% (51/100) of MS patients missed at least 1 dose of their DMT in the previous 28 days, with significant between-treatment differences. The MS-TAQ Barriers scale was positively correlated with the proportion of doses missed (r = .5), demonstrating a stronger relationship between adherence and perceived barriers than was found with clinical or demographic variables (r ≈ .3). The Coping Strategies subscale was negatively correlated with missed doses (r = -.3), suggesting that use of more coping strategies is associated with higher adherence. Conclusions Online communities can provide domains of interest and psychometric data to more rapidly develop and prototype patient-reported outcome instruments. The MS-TAQ offers patients and clinicians a simple method for identifying barriers to adherence, which may then be targeted through interventions.

BackgroundPatients with sarcoma often require individualized treatment strategies and are likely to receive aggressive immunosuppressive therapies, which may place them at higher risk for severe COVID-19. We aimed to describe demographics, risk factors, and outcomes for patients with sarcoma and COVID-19.MethodsWe performed a retrospective cohort study of patients with sarcoma and COVID-19 reported to the COVID-19 and Cancer Consortium (CCC19) registry (NCT04354701) from 17 March 2020 to 30 September 2021. Demographics, sarcoma histologic type, treatments, and COVID-19 outcomes were analyzed.Resultsof 281 patients, 49% (n = 139) were hospitalized, 33% (n = 93) received supplemental oxygen, 11% (n = 31) were admitted to the ICU, and 6% (n = 16) received mechanical ventilation. A total of 23 (8%) died within 30 days of COVID-19 diagnosis and 44 (16%) died overall at the time of analysis. When evaluated by sarcoma subtype, patients with bone sarcoma and COVID-19 had a higher mortality rate than patients from a matched SEER cohort (13.5% vs 4.4%). Older age, poor performance status, recent systemic anti-cancer therapy, and lung metastases all contributed to higher COVID-19 severity.ConclusionsPatients with sarcoma have high rates of severe COVID-19 and those with bone sarcoma may have the greatest risk of death.

BackgroundHospitalized patients with COVID-19 have increased risks of venous (VTE) and arterial thromboembolism (ATE). Active cancer diagnosis and treatment are well-known risk factors; however, a risk assessment model (RAM) for VTE in patients with both cancer and COVID-19 is lacking.ObjectivesTo assess the incidence of and risk factors for thrombosis in hospitalized patients with cancer and COVID-19.MethodsAmong patients with cancer in the COVID-19 and Cancer Consortium registry (CCC19) cohort study, we assessed the incidence of VTE and ATE within 90 days of COVID-19-associated hospitalization. A multivariable logistic regression model specifically for VTE was built using a priori determined clinical risk factors. A simplified RAM was derived and internally validated using bootstrap.ResultsFrom March 17, 2020 to November 30, 2020, 2804 hospitalized patients were analyzed. The incidence of VTE and ATE was 7.6% and 3.9%, respectively. The incidence of VTE, but not ATE, was higher in patients receiving recent anti-cancer therapy. A simplified RAM for VTE was derived and named CoVID-TE (Cancer subtype high to very-high risk by original Khorana score +1, VTE history +2, ICU admission +2, D-dimer elevation +1, recent systemic anti-cancer Therapy +1, and non-Hispanic Ethnicity +1). The RAM stratified patients into two cohorts (low-risk, 0-2 points, n = 1423 vs. high-risk, 3+ points, n = 1034) where VTE occurred in 4.1% low-risk and 11.3% high-risk patients (c statistic 0.67, 95% confidence interval 0.63-0.71). The RAM performed similarly well in subgroups of patients not on anticoagulant prior to admission and moderately ill patients not requiring direct ICU admission.ConclusionsHospitalized patients with cancer and COVID-19 have elevated thrombotic risks. The CoVID-TE RAM for VTE prediction may help real-time data-driven decisions in this vulnerable population.

Objective: The primary aim of this systematic review is to assess the effectiveness of evidence‐based healthcare (EBHC) educational interventions on healthcare professionals' knowledge, skills, attitudes, behaviour of EBHC, clinical process and care outcomes. A secondary aim of the review is to assess the effects of important pedagogical moderating factors for EBHC educational interventions. Method: This systematic review used a forward and backward citation search strategy on the Web of Science platform (date of inception to 28 April 2023). Only randomised controlled trials (RCTs) and cluster RCTs which compared EBHC educational interventions for healthcare professionals were included. A random effects meta‐analysis was undertaken for EBHC compared with an active and nonactive control for all outcomes. Results: Sixty‐one RCTs were identified which included a total of 5208 healthcare professionals. There was a large effect for EBHC educational interventions compared with waiting list/no treatment/sham control on knowledge (SMD, 2.69; 95% CI, 1.26–4.14, GRADE Low), skills (SMD, 0.88; 95% CI, 0.25–1.73, Very Low Certainty), attitude (SMD, 0.81; 95% CI, 0.16–1.47, Very Low Certainty) and behaviour of EBHC (SMD, 0.82; 95% CI, 0.25–1.40, Very Low Certainty). Over time the effect of EBHC educational interventions substantially decreased with no evidence of effect at 6 months for any outcome except behaviour (SMD,1.72; 95% CI, 0.74–2.71, Low Certainty). There was some evidence that blended learning, active learning and consistency in the individual delivering the intervention may be important positive moderating factors. Conclusion: These findings suggest that EBHC educational interventions may have a large short‐term effect on improving healthcare professionals' knowledge, skills, attitude and behaviour of EBHC. These effects may be longer‐lasting regarding EBHC behaviour. In terms of pedagogy, blended learning, active learning, and consistency of the individual delivering the intervention may be important positive moderating factors. [ABSTRACT FROM AUTHOR]

Background: Telehealth for paediatric speech and language therapy became one of the most salient modes of service delivery during the COVID‐19 pandemic. Evidence for speech and language therapy services via telehealth in comparison to face‐to‐face delivery demonstrates promising outcomes, and studies have begun to explore practitioner and client experiences. However, across the literature, many critical elements of services are overlooked, and there is a need to frame the evidence base within a theoretical model that can draw out practical implications that consider the range of factors having an impact on clinical implementation in real‐world contexts. The APEASE (Acceptability, Practicability, Effectiveness, Affordability, Side‐effects, and Equity) criteria offer such a model. The current study explored practising UK speech and language therapists' (SLTs) clinical experience of telehealth through the lens of the APEASE criteria and aimed to identify recommendations for future service provision from the practitioner perspective. Methods: An online survey structured using the APEASE criteria was developed in collaboration with the UK Royal College of Speech and Language Therapists. Quantitative data were analysed using descriptive statistics and qualitative data were analysed using reflexive thematic analysis. Results: Four hundred and thirty‐eight qualified and practicing UK paediatric SLTs completed the survey. Telehealth was broadly acceptable and practicable to SLTs yet there remains some uncertainty about its efficacy and cost‐effectiveness compared to face‐to‐face interventions and how equitable it is for different population groups. SLTs reported that effective implementation of telehealth services was dependent upon several contextual factors; affordability was a perceived barrier to clients having access to telehealth resources, intervention via telehealth was perceived as more acceptable than assessment, and whilst many SLTs welcomed aspects of telehealth, there were concerns about the physical and mental health consequences for practitioners. Six themes for the future development of telehealth in paediatric speech and language therapy were identified: (1) balanced and tailored services; (2) technology and equipment; (3) information and communication; (4) capacity building; (5) monitoring and evaluation; and (6) leadership and governance. Conclusions: Outcomes highlight promising, concerning and uncertain aspects of telehealth in paediatric speech and language therapy. SLTs value a flexible and tailored approach to service delivery and recommend that effective leadership, clear communication, ongoing policy and guidance development, upskilling of users and careful evaluation of impact are required to ensure optimal implementation. The APEASE criteria offer a valuable opportunity to enhance and streamline practice and research to ensure sustainable implementation of telehealth in the paediatric speech and language therapy services of tomorrow. WHAT THIS PAPER ADDS: What is already known on this subject: The COVID‐19 pandemic led to the increased use of telehealth as a main mode of service delivery in paediatric speech and language therapy. Pre‐COVID‐19, evidence for the use of telehealth in this field included small‐scale experimental studies that reported on children with particular disorders and explored telehealth outcomes in comparison to face‐to‐face delivery. The realities of at‐scale clinical practice were not well‐represented, and critical elements of service such as cost‐effectiveness were often overlooked in the paediatric literature. Furthermore, despite emerging global evidence for temporary telehealth responses to the crisis in speech and language therapy, the long‐term and future use of telehealth remains unclear. What this paper adds to existing knowledge: The current study applied the lens of the APEASE (Acceptability, Practicability, Effectiveness, Affordability, Side‐effects, and Equity) criteria, which were used in this case to consider socioeconomic, ecological and cultural factors to capture an overarching understanding of the use of telehealth in paediatric speech and language therapy, and to inform the role of telehealth in future, longer‐term and at‐scale service development. Results indicated emerging trends in UK paediatric speech and language therapists' (SLTs') perceptions of telehealth and SLTs perceived a hybrid approach to service delivery, combining mostly face‐to‐face services with some telehealth, was likely to continue in the future. We identified six themes to guide the future development of telehealth in paediatric speech and language therapy services: (1) balanced and tailored services; (2) technology and equipment; (3) information and communication; (4) capacity building; (5) monitoring and evaluation; and (6) leadership and governance. What are the potential or actual clinical implications of this work?: UK SLTs believe that speech and language therapy services using telehealth should be reflective, tailored and flexible to meet the requirements and circumstances of the children, young people and families served, as well as the physical and emotional needs of practitioners. SLTs recommend that this service development is clearly communicated to all stakeholders and suggested that those using telehealth should be supported through appropriate training, and ongoing effectiveness should be monitored. Telehealth is here to stay and the APEASE criteria offer a unique opportunity to ensure sustainable models of service delivery; to support co‐ordinated leadership at the local, national and international levels and the development of policy and clinical guidance. [ABSTRACT FROM AUTHOR]