Protocol of the process evaluation of cluster randomised control trial for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FluCare).

BACKGROUND: Influenza (flu) vaccination rates in UK care home staff are extremely low. Less than 40% of staff in care homes are vaccinated for influenza (flu), presenting risks to the health of frail residents and potential staff absence from cross-infection. Staff often do not perceive a need for vaccination and are unaware they are entitled to free flu vaccination. The FluCare study, a cluster randomised control trial (RCT), uses behavioural interventions to address barriers. Videos, posters, and leaflets are intended to raise awareness of flu vaccination benefits and debunk myths. On-site staff vaccination clinics increase accessibility. Financial incentives to care homes for improved vaccination rates and regular monitoring influence the environment. This paper outlines the planned process evaluation which will describe the intervention's mechanisms of action, explain any changes in outcomes, identify local adaptations, and inform design of the implementation phase. METHODS/DESIGN: A mixed method process evaluation to inform the interpretation of trial findings. OBJECTIVES: • Describe the intervention as delivered in terms of dose and fidelity, including adaptations and variations across care homes. • Explore the effects of individual intervention components on primary outcomes. • Investigate the mechanisms of impact. • Describe the perceived effectiveness of relevant intervention components (including videos, leaflets, posters, and flu clinics) from participant perspectives (care home manager, care home staff, flu clinic providers). • Describe the characteristics of care homes and participants to assess reach. A purposive sample of twenty care homes (ten in the intervention arm, ten in the control arm) for inclusion in the process evaluation. Data will include (1) study records including care home site profiles, (2) responses to a mechanism of action questionnaire, and (3) semi-structured interviews with care home staff and clinic providers. Quantitative data will be descriptively reported. Interview data will be thematically analysed and then categories mapped to the Theoretical Domains Framework. DISCUSSION: Adopting this systematic and comprehensive process evaluation approach will help ensure data is captured on all aspects of the trial, enabling a full understanding of the intervention implementation and RCT findings. TRIAL REGISTRATION: ISRCTN ISRCTN22729870. Registered on 24 August 2022.

A systematic review of barriers and enablers associated with uptake of influenza vaccine among care home staff.

Barriers and enablers to vaccination of care home (CH) staff should be identified in order to develop interventions to address them that increase uptake and protect residents. We aimed to synthesis the evidence describing the barriers and enablers that affect the influenza vaccination uptake of care home (CH) staff. METHOD: We searched PubMed, MEDLINE, EMBASE, CINAHL, PsycINFO, AMED, IBSS, SCOPUS to identify quantitative, qualitative or mixed-method studies. Data related to health or social care workers in CHs reported barriers or enablers were extracted and mapped to the Theoretical Domains Framework (TDF); the data within each domain were grouped and categorized into key factors affecting influenza vaccine uptake among CH staff. RESULTS: We screened 4025 studies; 42 studies met our inclusion criteria. Thirty-four (81 %) were surveys. Five theoretical domains were frequently reported as mediators of influenza vaccine uptake: Beliefs about consequences (32 studies), Environmental context and resources (30 studies), Emotions (26 studies), Social influences (25 studies), Knowledge (22 studies). The low acceptance rate of the influenza vaccine among CH staff can be attributed to multiple factors, including insufficient understanding of the vaccine, its efficacy, or misconceptions about the vaccine (knowledge), perceiving the vaccine as ineffective and unsafe (beliefs about consequences), fear of influenza vaccine and its side effects (emotions), and experiencing limited accessibility to the vaccine (environmental context and resources). CONCLUSION: Interventions aimed at increasing influenza vaccine uptake among CH staff should focus on addressing the barriers identified in this review. These interventions should include components such as enhancing knowledge by providing accurate information about vaccine benefits and safety, addressing negative beliefs by challenging misconceptions, managing concerns and fears through open communication, and improving accessibility to the vaccine through convenient on-site options. This review provides a foundation for the development of tailored Interventions to improve influenza vaccine uptake among CH staff.

Measurement of Moisture Content in Pharmaceutical Tablets by Handheld Near-Infrared Spectrometer: Adopting Quality by Design Approach to Analytical Method Lifecycle Management.

Control of moisture content in pharmaceutical solids (raw materials and solid dosage forms) is a challenge to pharmaceutical development and manufacturing. Pharmaceutical solids come in several forms and presentations requiring different, and often lengthy, sample preparation methods for moisture determination. Rapid screening of samples for their moisture content calls for an analytical method that can provide in-situ measurement with no or minimal sample preparation. We presented a near-infrared (NIR) spectroscopic method for rapid and non-destructive measurement of moisture content in a pharmaceutical tablet product. A handheld NIR spectrometer was selected for the quantitative measurement because of its ease of use, low cost, and high signals selective to water absorption in the NIR spectral range. Analytical quality by design (QbD) principles were explored during method design, qualification, and continued performance verification to increase robustness and promote continuous improvement of the analytical procedure. The International Council for harmonization (ICH) Q2 validation criteria were followed for validation of its linearity, range, accuracy, repeatability, intermediate precision, and method robustness. Limit of detection and limit of quantitation were also estimated based on the multivariate nature of the method. Practical considerations were also given to method transfer and a lifecycle approach to implementation of the method.

Practice Patterns and Management Protocols in Trauma across Indian Settings: A Nationwide Cross-sectional Survey.

Background: Trauma is the leading cause of death in India resulting in a significant public health burden. Indian Society of Critical Care Medicine (ISCCM) has established a trauma network committee to understand current practices and identify the gaps and challenges in trauma management in Indian settings. Material and methods: An online survey-based, cross-sectional, descriptive study was conducted with high-priority research questions based on hospital profile, resource availability, and trauma management protocols. Results: Data from 483 centers were analyzed. A significant difference was observed in infrastructure, resource utilization, and management protocols in different types of hospitals and between small and big size hospitals across different tier cities in India (p < 0.05). The advanced trauma life support (ATLS)-trained emergency room (ER) physician had a significant impact on infrastructure organization and trauma management protocols (p < 0.05). On multivariate analysis, the highest impact of ATLS-trained ER physicians was on the use of extended focused assessment with sonography in trauma (eFAST) (2.909 times), followed by hospital trauma code (2.778 times), dedicated trauma team (1.952 times), and following trauma scores (1.651 times). Conclusion: We found that majority of the centers are well equipped with optimal infrastructure, ATLS-trained physician, and management protocols. Still many aspects of trauma management need to be prioritized. There should be proactive involvement at an organizational level to manage trauma patients with a multidisciplinary approach. This survey gives us a deep insight into the current scenario of trauma care and can guide to strengthen across the country. How to cite this article: Sodhi K, Khasne RW, Chanchalani G, Jagathkar G, Kola VR, Mishra M et al. Practice Patterns and Management Protocols in Trauma across Indian Settings: A Nationwide Cross-sectional Survey. Indian J Crit Care Med 2023;27(1):38-51.

Quantum Cascade Laser Based Infrared Spectroscopy: A New Paradigm for Protein Secondary Structure Measurement.

Mid-infrared spectroscopy is one of the major analytical techniques employed for measurements of protein structure in solution. Traditional Fourier Transform-Infrared (FT-IR) measurement is limited by its blackbody light source that is inherently spatially incoherent and has low optical power output. This limitation is pronounced when working with proteins in aqueous solutions. Strong absorbance of water in protein amide I region 1600-1700 cm-1 restricts light path length to <10 µm and imposes significant experimental challenges in sample and flow cell handling. Emerging laser spectroscopic techniques use high-power coherent laser as light source that overcomes the limitation in FT-IR measurement. In this study, we employed an innovative infrared spectrometer that uses quantum cascade laser (QCL) as light source. Continuous infrared radiation from this laser source can be swiftly swept within the amide I region (1600-1700 cm-1) and amide II region (1500-1600 cm-1), which makes this technique ideal for protein secondary structure study. Protein solutions as low as 0.5 mg/mL were measured rapidly without any sample preparation. Infrared spectra of model proteins were thus collected, and a chemometric model based on partial least squares regression was developed to quantify α-helix and ß-strand motifs in protein secondary structure. The model was applied to measurement of the native secondary structure of commercial therapeutic proteins and bovine serum albumin (BSA) and in thermal degradation studies.

Cluster randomised control trial protocol for estimating the effectiveness and cost-effectiveness of a complex intervention to increase care home staff influenza vaccination rates compared to usual practice (FLUCARE).

The care home staff influenza vaccination rate in England is significantly lower than the 75% World Health Organisation recommendation. This represents a substantial potential for resident harm. Barriers to staff vaccination stem from individual and organisational levels. Existing interventions address some but not all barriers and are not underpinned by behavioural science theory. This study aims to estimate the effectiveness and cost-effectiveness of a theory-informed intervention to improve care home staff vaccination rates compared to routine practice.Set in care homes with both nursing and residential focus, and a range of ownership status, only homes providing long stay care to older people with a staff vaccination rate below 40% are eligible to participate. Participation expressions of interest will be sought using a variety of approaches prior to seeking consent.The primary outcome measure is the proportion of staff vaccinated at 6 months, with secondary outcome measures being proportion vaccinated at 3 months, numbers of staff sick days, general practitioner and nurse visits to care home, care home resident hospitalisations and mortality.Based on the assumptions that the mean cluster (care home) size is 54 staff, a coefficient of variation of 0.48, control vaccination rate is 55%, intervention 75%, intra-cluster correlation coefficient of 0.2 and with 90% power, and 20% attrition, we require 39 care homes per arm.Blocked randomisation will be at the level of care home, stratified by the proportion of non-white care home staff, and implemented by Norwich Clinical Trials Unit.The intervention comprises co-designed information videos and posters, provision of in-house staff vaccination clinics, and incentive scheme and monthly data collection on trial outcomes. Beyond usual practice, the control arm will additionally contribute monthly data.Data will be collected at the start, monthly and at 6 months, and analysis will be blind to allocation. Statistical analysis will use the intention-to-treat principle with the difference in vaccination rates between groups compared using a random effect logistic regression model at the staff-level.This will be the first study to use a theory-informed intervention designed to comprehensively address identified barriers to care home staff influenza vaccination.Trial registration: ISRCTN ISRCTN22729870 . Registered on 24 August 22. Secondary identifiers: R209939, IRAS 316820, CPMS 53812.

Suggested Curricular Guidelines for Musculoskeletal and Sports Medicine in Physical Medicine and Rehabilitation Residency Training.

ABSTRACT: A sports medicine physician manages musculoskeletal (MSK) injuries and sport-related medical and MSK conditions of patients of all ages and abilities. Physical medicine and rehabilitation physicians (physiatrists) must be adequately trained to provide this care for all patients including, but not limited to, athletes participating in organized sports, the weekend warrior as well as athletes with disabilities. Accreditation Council of Graduate Medical Education core requirements and basic guidelines help physiatry residency training programs develop and implement residency curriculums. The goal of this article is to provide suggested curricular guidelines to optimize physiatrist training in MSK and sports medicine.

Effect of Statewide Lockdown in Response to COVID-19 Pandemic on Physical Activity Levels of Hemodialysis Patients.

BACKGROUND/OBJECTIVES: On March 22, 2020, a statewide stay-at-home order for nonessential tasks was implemented in New York State. We aimed to determine the impact of the lockdown on physical activity levels (PAL) in hemodialysis patients. METHODS: Starting in May 2018, we are conducting an observational study with a 1-year follow-up on PAL in patients from 4 hemodialysis clinics in New York City. Patients active in the study as of March 22, 2020, were included. PAL was defined by steps taken per day measured by a wrist-based monitoring device (Fitbit Charge 2). Average steps/day were calculated for January 1 to February 13, 2020, and then weekly from February 14 to June 30. RESULTS: 42 patients were included. Their mean age was 55 years, 79% were males, and 69% were African Americans. Between January 1 and February 13, 2020, patients took on average 5,963 (95% CI 4,909-7,017) steps/day. In the week prior to the mandated lockdown, when a national emergency was declared, and in the week of the shutdown, the average number of daily steps had decreased by 868 steps/day (95% CI 213-1,722) and 1,222 steps/day (95% CI 668-2300), respectively. Six patients were diagnosed with COVID-19 during the study period. Five of them exhibited significantly higher PAL in the 2 weeks prior to showing COVID-19 symptoms compared to COVID-19 negative patients. CONCLUSION: Lockdown measures were associated with a significant decrease in PAL in hemodialysis patients. Patients who contracted COVID-19 had higher PAL during the incubation period. Methods to increase PAL while allowing for social distancing should be explored and implemented.

SARS-CoV-2 in Spent Dialysate from Chronic Peritoneal Dialysis Patients with COVID-19.

Background: To date, it is unclear whether SARS-CoV-2 is present in spent dialysate from patients with COVID-19 on peritoneal dialysis (PD). Our aim was to assess the presence or absence of SARS-CoV-2 in spent dialysate from patients on chronic PD who had a confirmed diagnosis of COVID-19. Methods: Spent PD dialysate samples from patients on PD who were positive for COVID-19 were collected between March and August 2020. The multiplexed, real-time RT-PCR assay contained primer/probe sets specific to different SARS-CoV-2 genomic regions and to bacteriophage MS2 as an internal process control for nucleic acid extraction. Demographic and clinical data were obtained from patients' electronic health records. Results: A total of 26 spent PD dialysate samples were collected from 11 patients from ten dialysis centers. Spent PD dialysate samples were collected, on average, 25±13 days (median, 20; range, 10-45) after the onset of symptoms. The temporal distance of PD effluent collection relative to the closest positive nasal-swab RT-PCR result was 15±11 days (median, 14; range, 1-41). All 26 PD effluent samples tested negative at three SARS-CoV-2 genomic regions. Conclusions: Our findings indicate the absence of SARS-CoV-2 in spent PD dialysate collected at ≥10 days after the onset of COVID-19 symptoms. We cannot rule out the presence of SARS-CoV-2 in spent PD dialysate in the early stage of COVID-19.

SARS-CoV-2 viral sepsis with meningoencephalitis.

SARS-CoV-2 predominantly involves the lungs producing acute lung injury, but it can also give rise to a variety of complications involving the central nervous system, gastrointestinal system, kidney and also viral sepsis. With this case report, we are discussing unusual series of complication from acute lung injury, followed by viral sepsis then encephalitis, followed by progressive macrophage activation syndrome.

Identification of the putative bryostatin polyketide synthase gene cluster from "Candidatus Endobugula sertula", the uncultivated microbial symbiont of the marine bryozoan Bugula neritina.

The bryostatins are protein kinase C modulators with unique structural features and potential anticancer and neurological activities. These complex polyketides were isolated from the marine bryozoan Bugula neritina, but recent studies indicate that they are produced by the uncultured symbiotic bacterium "Candidatus Endobugula sertula" ("E. sertula"). Here we present the putative biosynthetic genes: five modular polyketide synthase (PKS) genes, a discrete acyltransferase, a beta-ketosynthase, a hydroxy-methyl-glutaryl CoA synthase (HMG-CS), and a methyltransferase. The cluster was sequenced in two closely related "E. sertula" strains from different host species. In one strain the gene cluster is contiguous, while in the other strain it is split into two loci, with one locus containing the PKS genes and the other containing the accessory genes. Here, we propose a hypothesis for the biosynthesis of the bryostatins. Thirteen PKS modules form the core macrolactone ring, and the pendent methyl ester groups are added by the HMG-CS gene cassette. The resulting hypothetical compound bryostatin 0 is the common basis for the 20 known bryostatins. As "E. sertula" is to date uncultured, heterologous expression of this biosynthetic gene cluster has the potential of producing the bioactive bryostatins in large enough quantities for development into a pharmaceutical.