Microbiota dictate T cell clonal selection to augment graft-versus-host disease after stem cell transplantation.

Allogeneic T cell expansion is the primary determinant of graft-versus-host disease (GVHD), and current dogma dictates that this is driven by histocompatibility antigen disparities between donor and recipient. This paradigm represents a closed genetic system within which donor T cells interact with peptide-major histocompatibility complexes (MHCs), though clonal interrogation remains challenging due to the sparseness of the T cell repertoire. We developed a Bayesian model using donor and recipient T cell receptor (TCR) frequencies in murine stem cell transplant systems to define limited common expansion of T cell clones across genetically identical donor-recipient pairs. A subset of donor CD4+ T cell clonotypes differentially expanded in identical recipients and were microbiota dependent. Microbiota-specific T cells augmented GVHD lethality and could target microbial antigens presented by gastrointestinal epithelium during an alloreactive response. The microbiota serves as a source of cognate antigens that contribute to clonotypic T cell expansion and the induction of GVHD independent of donor-recipient genetics.

Signaling via a CD27-TRAF2-SHP-1 axis during naive T cell activation promotes memory-associated gene regulatory networks.

The interaction of the tumor necrosis factor receptor (TNFR) family member CD27 on naive CD8+ T (Tn) cells with homotrimeric CD70 on antigen-presenting cells (APCs) is necessary for T cell memory fate determination. Here, we examined CD27 signaling during Tn cell activation and differentiation. In conjunction with T cell receptor (TCR) stimulation, ligation of CD27 by a synthetic trimeric CD70 ligand triggered CD27 internalization and degradation, suggesting active regulation of this signaling axis. Internalized CD27 recruited the signaling adaptor TRAF2 and the phosphatase SHP-1, thereby modulating TCR and CD28 signals. CD27-mediated modulation of TCR signals promoted transcription factor circuits that induced memory rather than effector associated gene programs, which are induced by CD28 costimulation. CD27-costimulated chimeric antigen receptor (CAR)-engineered T cells exhibited improved tumor control compared with CD28-costimulated CAR-T cells. Thus, CD27 signaling during Tn cell activation promotes memory properties with relevance to T cell immunotherapy.

The quality of care delivered to residents in long-term care in Australia: an indicator-based review of resident records (CareTrack Aged study).

BACKGROUND: This study estimated the prevalence of evidence-based care received by a population-based sample of Australian residents in long-term care (LTC) aged ≥ 65 years in 2021, measured by adherence to clinical practice guideline (CPG) recommendations. METHODS: Sixteen conditions/processes of care amendable to estimating evidence-based care at a population level were identified from prevalence data and CPGs. Candidate recommendations (n = 5609) were extracted from 139 CPGs which were converted to indicators. National experts in each condition rated the indicators via the RAND-UCLA Delphi process. For the 16 conditions, 236 evidence-based care indicators were ratified. A multi-stage sampling of LTC facilities and residents was undertaken. Trained aged-care nurses then undertook manual structured record reviews of care delivered between 1 March and 31 May 2021 (our record review period) to assess adherence with the indicators. RESULTS: Care received by 294 residents with 27,585 care encounters in 25 LTC facilities was evaluated. Residents received care for one to thirteen separate clinical conditions/processes of care (median = 10, mean = 9.7). Adherence to evidence-based care indicators was estimated at 53.2% (95% CI: 48.6, 57.7) ranging from a high of 81.3% (95% CI: 75.6, 86.3) for Bladder and Bowel to a low of 12.2% (95% CI: 1.6, 36.8) for Depression. Six conditions (skin integrity, end-of-life care, infection, sleep, medication, and depression) had less than 50% adherence with indicators. CONCLUSIONS: This is the first study of adherence to evidence-based care for people in LTC using multiple conditions and a standardised method. Vulnerable older people are not receiving evidence-based care for many physical problems, nor care to support their mental health nor for end-of-life care. The six conditions in which adherence with indicators was less than 50% could be the focus of improvement efforts.

Increasing the versatility of the biphenyl-fused-dioxacyclodecyne class of strained alkynes.

Biphenyl-fused-dioxacyclodecynes are a promising class of strained alkyne for use in Cu-free 'click' reactions. In this paper, a series of functionalised derivatives of this class of reagent, containing fluorescent groups, are described. Studies aimed at understanding and increasing the reactivity of the alkynes are also presented, together with an investigation of the bioconjugation of the reagents with an azide-labelled protein.

The role of body mass index in survivorship and clinical outcomes in total shoulder arthroplasty.

BACKGROUND: Increased body mass index (BMI) is a potential risk factor for poorer outcomes and complications. However, the influence of BMI on the long-term outcomes of anatomic total shoulder arthroplasty (aTSA) and reverse total shoulder arthroplasty (rTSA) remains to be fully elucidated. METHODS: Institutional records were queried to identify patients who underwent primary total shoulder arthroplasty (TSA) between 2009 and 2020 with a minimum of 2 years of clinical follow-up. Retrospective review was performed to collect demographic characteristics; comorbidity status; and range-of-motion and strength measurements in forward elevation, external rotation, and internal rotation. Patients were contacted by telephone to provide patient-reported outcomes (PROs). Patients were stratified into 3 cohorts by BMI: underweight or normal weight (U/NW, BMI ≤25 kg/m2), overweight (OW, BMI >25 to ≤30 kg/m2), and obese (BMI >30 kg/m2). RESULTS: Among 466 TSA patients, 245 underwent aTSA whereas 221 underwent rTSA. In the aTSA cohort, 40 patients were classified as U/NW; 72, as OW; and 133, as obese. Comparatively, the rTSA cohort was composed of 33 U/NW, 79 OW, and 209 obese patients. Patients in the aTSA and rTSA cohorts had an average follow-up period of 5.8 ± 3.2 years and 4.5 ± 2.3 years, respectively. No differences in age at surgery were found in the aTSA group (U/NW vs. obese, 65.2 ± 7.9 years vs. 61.9 ± 8.9 years; P = .133); however, in the rTSA cohort, BMI was found to be inversely related to age at surgery (U/NW vs. obese, 72.4 ± 8.8 years vs. 65.7 ± 8.3 years; P < .001). Across all BMI cohorts, patients saw great improvements in range of motion and strength. Postoperative PROs after TSA did not vary by BMI in terms of Single Assessment Numeric Evaluation, Simple Shoulder Test, visual analog scale pain, and American Shoulder and Elbow Surgeons scores. There was no significant difference in survival rates at 10-year follow-up in the aTSA cohort (U/NW vs. obese, 95.8% vs. 93.2%; P = .753) or rTSA cohort (U/NW vs. obese, 94.7% vs. 94.5%; P = .791). CONCLUSION: With dramatic improvements in range of motion, minimal differences in PROs, and high rates of implant survival, TSA is a safe and effective treatment option for all patients, including overweight and obese patients.

Programme theories to describe how different general practitioner service models work in different contexts in or alongside emergency departments (GP-ED): realist evaluation.

BACKGROUND: Addressing increasing patient demand and improving ED patient flow is a key ambition for NHS England. Delivering general practitioner (GP) services in or alongside EDs (GP-ED) was advocated in 2017 for this reason, supported by £100 million (US$130 million) of capital funding. Current evidence shows no overall improvement in addressing demand and reducing waiting times, but considerable variation in how different service models operate, subject to local context. METHODS: We conducted mixed-methods analysis using inductive and deductive approaches for qualitative (observations, interviews) and quantitative data (time series analyses of attendances, reattendances, hospital admissions, length of stay) based on previous research using a purposive sample of 13 GP-ED service models (3 inside-integrated, 4 inside-parallel service, 3 outside-onsite and 3 with no GPs) in England and Wales. We used realist methodology to understand the relationship between contexts, mechanisms and outcomes to develop programme theories about how and why different GP-ED service models work. RESULTS: GP-ED service models are complex, with variation in scope and scale of the service, influenced by individual, departmental and external factors. Quantitative data were of variable quality: overall, no reduction in attendances and waiting times, a mixed picture for hospital admissions and length of hospital stay. Our programme theories describe how the GP-ED service models operate: inside the ED, integrated with patient flow and general ED demand, with a wider GP role than usual primary care; outside the ED, addressing primary care demand with an experienced streaming nurse facilitating the 'right patients' are streamed to the GP; or within the ED as a parallel service with most variability in the level of integration and GP role. CONCLUSION: GP-ED services are complex . Our programme theories inform recommendations on how services could be modified in particular contexts to address local demand, or whether alternative healthcare services should be considered.

Analysis of applying a patient safety taxonomy to patient and clinician-reported incident reports during the COVID-19 pandemic: a mixed methods study.

BACKGROUND: The COVID-19 pandemic resulted in major disruption to healthcare delivery worldwide causing medical services to adapt their standard practices. Learning how these adaptations result in unintended patient harm is essential to mitigate against future incidents. Incident reporting and learning system data can be used to identify areas to improve patient safety. A classification system is required to make sense of such data to identify learning and priorities for further in-depth investigation. The Patient Safety (PISA) classification system was created for this purpose, but it is not known if classification systems are sufficient to capture novel safety concepts arising from crises like the pandemic. We aimed to review the application of the PISA classification system during the COVID-19 pandemic to appraise whether modifications were required to maintain its meaningful use for the pandemic context. METHODS: We conducted a mixed-methods study integrating two phases in an exploratory, sequential design. This included a comparative secondary analysis of patient safety incident reports from two studies conducted during the first wave of the pandemic, where we coded patient-reported incidents from the UK and clinician-reported incidents from France. The findings were presented to a focus group of experts in classification systems and patient safety, and a thematic analysis was conducted on the resultant transcript. RESULTS: We identified five key themes derived from the data analysis and expert group discussion. These included capitalising on the unique perspective of safety concerns from different groups, that existing frameworks do identify priority areas to investigate further, the objectives of a study shape the data interpretation, the pandemic spotlighted long-standing patient concerns, and the time period in which data are collected offers valuable context to aid explanation. The group consensus was that no COVID-19-specific codes were warranted, and the PISA classification system was fit for purpose. CONCLUSIONS: We have scrutinised the meaningful use of the PISA classification system's application during a period of systemic healthcare constraint, the COVID-19 pandemic. Despite these constraints, we found the framework can be successfully applied to incident reports to enable deductive analysis, identify areas for further enquiry and thus support organisational learning. No new or amended codes were warranted. Organisations and investigators can use our findings when reviewing their own classification systems.

Mapping Processes in the Emergency Department Using the Functional Resonance Analysis Method.

Emergency departments (EDs) are dynamic, complex, and demanding environments. Introducing changes that lead to improvements in EDs can be challenging owing to the high staff turnover and mix, high patient volume with different needs, and being the front door to the hospital for the sickest patients. Quality improvement is a methodology applied routinely in EDs to instigate change to improve several outcomes such as waiting times, time to definitive treatment, and patient safety. Introducing the changes needed to transform the system in this way is seldom straightforward with the risk of "not seeing the forest for the trees" when attempting to change the system. In this article, we demonstrate how the functional resonance analysis method can be used to capture the experiences and perceptions of frontline staff to identify the key functions in the system (the trees), to understand the interactions and dependencies between them to make up the ED ecosystem ("the forest") and to support quality improvement planning, identifying priorities and patient safety risks.

Evaluation of an EMS-Based Community Paramedic Pilot Program to Reduce Frequency of 9-1-1 Calls among High Utilizers.

BACKGROUND: Many community paramedic interventions aim to reduce unnecessary emergency department visits among high utilizers of acute care, but fewer focus specifically on reducing summons for emergency medical services (EMS). We implemented an EMS-based pilot program that identified high utilizers of 9-1-1 and facilitated community paramedic outreach encounters to understand and address potentially unnecessary 9-1-1 calls. This study compares the pre- and post-intervention incidence rate of 9-1-1 calls among program participants. METHODS: This retrospective evaluation was conducted using pilot data from a single U.S. EMS agency that responds to approximately 100,000 9-1-1 calls annually. High utilizers, defined as individuals with ≥3 9-1-1 calls in 90 days, were identified for recruitment between February 1, 2019 and December 31, 2019. Community paramedics recruited participants via phone and then conducted home visits to assist them with navigation away from unnecessary 9-1-1 use. Dispatch data from September 1, 2018 to December 31, 2019 were used to compute the incidence rate of 9-1-1 calls per 30 person-days of observation before and after the initial home visits. RESULTS: Data from 108 program participants were analyzed. The majority were over the age of 50 (79%), and 33% completed more than one visit. Median person-days of observation before and after the initial home visit were 354 days and 132 days, respectively. Participants called 9-1-1 an average of 0.68 times per 30 person-days prior to the community paramedic intervention, and 0.51 times per 30 person-days after the intervention, which represents an overall mean decrease in 9-1-1 utilization of 25% (p < 0.001). Although a decrease in 9-1-1 utilization was observed in the majority of participants, the 9-1-1 call rate increased in 29% of participants. No statistically significant changes in 9-1-1 use were observed in participants who received more than one home visit or who were in the highest quartile of 9-1-1 use prior to the intervention. CONCLUSION: This pilot work demonstrates the feasibility of an EMS-based, community paramedic-only intervention to reduce unnecessary 9-1-1 calls and suggests that some modest reductions in EMS use may be achievable by dispatching community paramedics to conduct home visits with frequent users of 9-1-1.

A Retrospective, Single-Agency Analysis of Ambulance Crashes during a 3-Year Period: Association with EMS Driver Characteristics and a Telematics-Measured Safe Driving Score.

BACKGROUND: Driver demographics and aggressive driving behavior are established risk factors for traffic accidents, yet their role in ambulance crashes remains poorly studied. We reviewed all ambulance crashes that occurred in our emergency medical services (EMS) agency during a 3-year period, and examined incidence rates (IR) by driver characteristics and telematics-measured driver behavior. METHODS: This retrospective study was conducted in a U.S. EMS agency that operates 75 Type III ambulances and requires personnel to document all ambulance collisions, regardless of severity. Crashes reported between September 2017 and August 2020 were reviewed, and established criteria were used to classify injury and vehicle damage severity. Serious crashes were defined as events with any injury and/or functional or disabling damage. A vehicle telematics system installed fleet-wide in 2017 continuously captures driver-specific data, including miles driven and indicators related to speeding, harsh cornering and braking, and seatbelt use. A composite score characterizes compliance with safe driving behaviors (1 = low compliance to 5 = high compliance). Crash IR per 100,000 miles, IR ratios (IRR), and Poisson regression were used in analysis. Driver sex, age, agency tenure, miles driven, and safe driving score were examined. RESULTS: Clinicians reported 214 crashes and the IR of any crash and serious crash were 2.1 and 0.63 per 100,000 miles, respectively. Injuries occurred in 8% of crashes and were all of low acuity. About one third of crashes produced functional (21%) or disabling (8%) vehicle damage, and the ambulance required towing in 10%. In a multivariate model, female sex (IRR = 1.50, 95%CI = 1.13-1.97), age 18-24 (IRR = 1.67, 95%CI = 1.06-2.66), and being in the lowest quartile of safe driving score (IRR = 1.51, 95%CI = 1.14-2.02) were EMS driver factors independently associated with an increased risk of any collision. CONCLUSION: Most ambulance crashes are minor events, but the proportion that result in injury and/or functional or disabling vehicle damage may be as high as one-third. Poor driver compliance with objectively measured safe driving behaviors may increase risk for collisions independent of driver sex and age. The EMS industry would benefit from additional studies that examine the full spectrum of ambulance crashes and expand understanding of EMS driver-related risk factors.

Elimination of Emergency Department Ambulance Divert during the COVID-19 Pandemic Was Not Associated with an Increase in the Average Number of Ambulance Arrivals per Day.

INTRODUCTION: During the COVID-19 pandemic, ambulance divert in our EMS system reached critical levels. We hypothesized that eliminating ambulance divert would not be associated with an increase in the average number of daily ambulance arrivals. Our study objective was to quantify the EMS and emergency department (ED) effects of eliminating ambulance divert during the COVID-19 pandemic. METHODS: Regional hospital divert data were obtained for the 10-county Twin Cities metro from MNTrac, a state-supported online system designed to allow hospitals to indicate their divert status to EMS. ED metrics are reported for a single Level I trauma center and were obtained by a deidentified data pull from our electronic medical record covering the 12 months prior to the elimination of divert (2021) and the 12 months after divert elimination (2022). The decision to eliminate divert occurred in November 2021, based on data available through October, with an implementation date of January 2022. The primary study outcome was to quantify the effect of the elimination of divert on the number of ambulances arriving per day at the study hospital. RESULTS: Regional utilization of ambulance divert increased steadily by 859% from January to October 2021 when 355 individual divert events occurred, totaling 809 h (34 days). There was no significant difference in the number of ambulances that arrived to the study hospital in 2021 (30,774) vs 2022 (30,421) p = 0.15. As compared to 2021, in 2022 there was no significant increase in mean ambulance arrivals per day (84/day vs 83/day, p = 0.08), time to room Emergency Severity Index level 2 (ESI) patients (28 min vs 28 min, p = 0.90), or time to obtain emergent head CT in acute "code stroke" patients (12 min vs 12 min, p = 0.15). Ambulance turnaround interval in the ED did not appreciably increase (16 min vs 17 min, p = 0.15). CONCLUSION: Elimination of ambulance divert was not associated with increases in the number of mean daily ambulance arrivals or EMS turnaround intervals, delays in ESI 2 patients being placed in beds, or prolonged time to head CT in stroke code patients.

The cost of implementing the COVID-19 shielding policy in Wales.

BACKGROUND: The EVITE Immunity study investigated the effects of shielding Clinically Extremely Vulnerable (CEV) people during the COVID-19 pandemic on health outcomes and healthcare costs in Wales, United Kingdom, to help prepare for future pandemics. Shielding was intended to protect those at highest risk of serious harm from COVID-19. We report the cost of implementing shielding in Wales. METHODS: The number of people shielding was extracted from the Secure Anonymised Information Linkage Databank. Resources supporting shielding between March and June 2020 were mapped using published reports, web pages, freedom of information requests to Welsh Government and personal communications (e.g. with the office of the Chief Medical Officer for Wales). RESULTS: At the beginning of shielding, 117,415 people were on the shielding list. The total additional cost to support those advised to stay home during the initial 14 weeks of the pandemic was £13,307,654 (£113 per person shielded). This included the new resources required to compile the shielding list, inform CEV people of the shielding intervention and provide medicine and food deliveries. The list was adjusted weekly over the 3-month period (130,000 people identified by June 2020). Therefore the cost per person shielded lies between £102 and £113 per person. CONCLUSION: This is the first evaluation of the cost of the measures put in place to support those identified to shield in Wales. However, no data on opportunity cost was available. The true costs of shielding including its budget impact and opportunity costs need to be investigated to decide whether shielding is a worthwhile policy for future health emergencies.

Comparing rates of adverse events detected in incident reporting and the Global Trigger Tool: a systematic review.

Many hospitals continue to use incident reporting systems (IRSs) as their primary patient safety data source. The information IRSs collect on the frequency of harm to patients [adverse events (AEs)] is generally of poor quality, and some incident types (e.g. diagnostic errors) are under-reported. Other methods of collecting patient safety information using medical record review, such as the Global Trigger Tool (GTT), have been developed. The aim of this study was to undertake a systematic review to empirically quantify the gap between the percentage of AEs detected using the GTT to those that are also detected via IRSs. The review was conducted in adherence to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) statement. Studies published in English, which collected AE data using the GTT and IRSs, were included. In total, 14 studies met the inclusion criteria. All studies were undertaken in hospitals and were published between 2006 and 2022. The studies were conducted in six countries, mainly in the USA (nine studies). Studies reviewed 22 589 medical records using the GTT across 107 institutions finding 7166 AEs. The percentage of AEs detected using the GTT that were also detected in corresponding IRSs ranged from 0% to 37.4% with an average of 7.0% (SD 9.1; median 3.9 and IQR 5.2). Twelve of the fourteen studies found <10% of the AEs detected using the GTT were also found in corresponding IRSs. The >10-fold gap between the detection rates of the GTT and IRSs is strong evidence that the rate of AEs collected in IRSs in hospitals should not be used to measure or as a proxy for the level of safety of a hospital. IRSs should be recognized for their strengths which are to detect rare, serious, and new incident types and to enable analysis of contributing and contextual factors to develop preventive and corrective strategies. Health systems should use multiple patient safety data sources to prioritize interventions and promote a cycle of action and improvement based on data rather than merely just collecting and analysing information.

Unsafe care in residential settings for older adults: a content analysis of accreditation reports.

Residents of aged care services can experience safety incidents resulting in preventable serious harm. Accreditation is a commonly used strategy to improve the quality of care; however, narrative information within accreditation reports is not generally analysed as a source of safety information to inform learning. In Australia, the Aged Care Quality and Safety Commission (ACQSC), the sector regulator, undertakes over 500 accreditation assessments of residential aged care services against eight national standards every year. From these assessments, the Aged Care Quality and Safety Commission generates detailed Site Audit Reports. In over one-third (37%) of Site Audit Reports, standards relating to Personal and Clinical Care (Standard 3) are not being met. The aim of this study was to identify the types of resident Safety Risks that relate to Personal and Clinical Care Standards not being met during accreditation or re-accreditation. These data could inform priority setting at policy, regulatory, and service levels. An analytical framework was developed based on the World Health Organization's International Classification for Patient Safety and other fields including Clinical Issue (the issue related to the incident impacting the resident, e.g. wound/skin or pain). Information relating to safety incidents in the Site Audit Reports was extracted, and a content analysis undertaken using the analytical framework. Clinical Issue and the International Classification for Patient Safety-based classification were combined to describe a clinically intuitive category ('Safety Risks') to describe ways in which residents could experience unsafe care, e.g. diagnosis/assessment of pain. The resulting data were descriptively analysed. The analysis included 65 Site Audit Reports that were undertaken between September 2020 and March 2021. There were 2267 incidents identified and classified into 274 types of resident Safety Risks. The 12 most frequently occurring Safety Risks account for only 32.3% of all incidents. Relatively frequently occurring Safety Risks were organisation management of infection control; diagnosis/assessment of pain, restraint, resident behaviours, and falls; and multiple stages of wounds/skin management, e.g. diagnosis/assessment, documentation, treatment, and deterioration. The analysis has shown that accreditation reports contain valuable data that may inform prioritization of resident Safety Risks in the Australian residential aged care sector. A large number of low-frequency resident Safety Risks were detected in the accreditation reports. To address these, organizations may use implementation science approaches to facilitate evidence-based strategies to improve the quality of care delivered to residents. Improving the aged care workforces' clinical skills base may address some of the Safety Risks associated with diagnosis/assessment and wound management.

Outcomes of Reverse Total Shoulder Arthroplasty Were Not Adversely Affected by the COVID-19 Pandemic.

Introduction: The objective was to investigate outcomes in reverse total shoulder arthroplasty (RTSA) in patients affected by the COVID-19 pandemic shutdown. We hypothesized that patients undergoing RTSA in early 2020 would have decreased access to physical therapy (PT) and worse postoperative outcomes compared to historical controls. Materials and Methods: Patients who received primary RTSA between 1/1/2020 to 3/17/2020 were included and patients who received primary RTSA between 1/1/2019 to 3/17/2019 were used as a control group. Retrospective chart review was performed, and patient reported outcomes were recorded at an average of 2.69 ± 0.06 years and a minimum of 1 year postoperatively. Patient data were collected and statistically analyzed using the 2-sample t-test and Chi-square test. The Mann Whitney U test and Fisher's Exact test were used when appropriate. Results: 38 patients in 2020 were included in this study and compared to 31 patients in 2019. RTSA performed in 2019 had improvements in forward elevation (FE) (95.7º ± 47.2º to 144.7º ± 17.2º, p<0.001), but not in external rotation (ER) (32.5º ± 20.3º to 41.0º ± 13.3º, p=0.15), or internal rotation (IR) (S1 to L5, p=0.76). RTSA 2020 cases had improvements in FE (111.5º ± 40.3 to 132.8º ± 30.6, p=0.016), but not ER (31.9º ± 18.2 to 35.7º ± 15.9, p=0.36) or IR (S1 to L5, p=0.13). Patients in 2019 (FE: 4 to 5-, p<0.001; ER: 4+ to 5-, p=0.003; IR: 5- to 5, p<0.001) and 2020 (FE: 4 to 5-, p<0.001; ER: 4+ to 5, p<0.001; IR: 5- to 5, p=0.02) both experienced improvements in strength. Patients in 2020 initiated PT later (2019: 39.3 ± 27.3 days, 2020: 57.1 ± 35.5 days, p=0.028) and completed less PT sessions (2019: 20.7 ± 11.1, 2020: 12.9 ± 6.6, p<0.001) than patients in 2019. In the 2020 cohort, 10.5% (4/38) did not complete any PT, 34.2% (13/38) reported a delay in initiating PT, and 47.4% (18/38) reported that their recovery was negatively affected by the COVID-19 pandemic. At final follow-up, patients in 2020 reported a mean SANE score of 73.6 ± 17.5 on their affected shoulder and a mean VAS score of 1.68 ± 1.23. Discussion: Despite a delay in initiating PT and completing less PT overall, patients who received RTSA in 2020 experienced significant improvements in ROM and strength at final follow-up and were comparable to the 2019 patients.

Safety and immunogenicity of concomitant administration of COVID-19 vaccines (ChAdOx1 or BNT162b2) with seasonal influenza vaccines in adults in the UK (ComFluCOV): a multicentre, randomised, controlled, phase 4 trial.

BACKGROUND: Concomitant administration of COVID-19 and influenza vaccines could reduce burden on health-care systems. We aimed to assess the safety of concomitant administration of ChAdOx1 or BNT162b2 plus an age-appropriate influenza vaccine. METHODS: In this multicentre, randomised, controlled, phase 4 trial, adults in receipt of a single dose of ChAdOx1 or BNT162b2 were enrolled at 12 UK sites and randomly assigned (1:1) to receive concomitant administration of either an age-appropriate influenza vaccine or placebo alongside their second dose of COVID-19 vaccine. 3 weeks later the group who received placebo received the influenza vaccine, and vice versa. Participants were followed up for 6 weeks. The influenza vaccines were three seasonal, inactivated vaccines (trivalent, MF59C adjuvanted or a cellular or recombinant quadrivalent vaccine). Participants and investigators were masked to the allocation. The primary endpoint was one or more participant-reported solicited systemic reactions in the 7 days after first trial vaccination(s), with a difference of less than 25% considered non-inferior. Analyses were done on an intention-to-treat basis. Local and unsolicited systemic reactions and humoral responses were also assessed. The trial is registered with ISRCTN, ISRCTN14391248. FINDINGS: Between April 1 and June 26, 2021, 679 participants were recruited to one of six cohorts, as follows: 129 ChAdOx1 plus cellular quadrivalent influenza vaccine, 139 BNT162b2 plus cellular quadrivalent influenza vaccine, 146 ChAdOx1 plus MF59C adjuvanted, trivalent influenza vaccine, 79 BNT162b2 plus MF59C adjuvanted, trivalent influenza vaccine, 128 ChAdOx1 plus recombinant quadrivalent influenza vaccine, and 58 BNT162b2 plus recombinant quadrivalent influenza vaccine. 340 participants were assigned to concomitant administration of influenza and a second dose of COVID-19 vaccine at day 0 followed by placebo at day 21, and 339 participants were randomly assigned to concomitant administration of placebo and a second dose of COVID-19 vaccine at day 0 followed by influenza vaccine at day 21. Non-inferiority was indicated in four cohorts, as follows: ChAdOx1 plus cellular quadrivalent influenza vaccine (risk difference for influenza vaccine minus placebos -1·29%, 95% CI -14·7 to 12·1), BNT162b2 plus cellular quadrivalent influenza vaccine (6·17%, -6·27 to 18·6), BNT162b2 plus MF59C adjuvanted, trivalent influenza vaccine (-12·9%, -34·2 to 8·37), and ChAdOx1 plus recombinant quadrivalent influenza vaccine (2·53%, -13·3 to 18·3). In the other two cohorts, the upper limit of the 95% CI exceeded the 0·25 non-inferiority margin (ChAdOx1 plus MF59C adjuvanted, trivalent influenza vaccine 10·3%, -5·44 to 26·0; BNT162b2 plus recombinant quadrivalent influenza vaccine 6·75%, -11·8 to 25·3). Most systemic reactions to vaccination were mild or moderate. Rates of local and unsolicited systemic reactions were similar between the randomly assigned groups. One serious adverse event, hospitalisation with severe headache, was considered related to the trial intervention. Immune responses were not adversely affected. INTERPRETATION: Concomitant vaccination with ChAdOx1 or BNT162b2 plus an age-appropriate influenza vaccine raises no safety concerns and preserves antibody responses to both vaccines. Concomitant vaccination with both COVID-19 and influenza vaccines over the next immunisation season should reduce the burden on health-care services for vaccine delivery, allowing for timely vaccine administration and protection from COVID-19 and influenza for those in need. FUNDING: National Institute for Health Research Policy Research Programme.

Implementing public involvement throughout the research process-Experience and learning from the GPs in EDs study.

BACKGROUND: Public involvement in health services research is encouraged. Descriptions of public involvement across the whole research cycle of a major study are uncommon and its effects on research conduct are poorly understood. AIM: This study aimed to describe how we implemented public involvement, reflect on process and effects in a large-scale multi-site research study and present learning for future involvement practice. METHOD: We recorded public involvement roles and activities throughout the study and compared these to our original public involvement plan included in our project proposal. We held a group interview with study co-applicants to explore their experiences, transcribed the recorded discussion and conducted thematic analysis. We synthesized the findings to develop recommendations for future practice. RESULTS: Public contributors' activities went beyond strategic study planning and management to include active involvement in data collection, analysis and dissemination. They attended management, scrutiny, planning and task meetings. They also facilitated public involvement through annual planning and review sessions, conducted a Public Involvement audit and coordinated public and patient input to stakeholder discussions at key study stages. Group interview respondents said that involvement exceeded their expectations. They identified effects such as changes to patient recruitment, terminology clarification and extra dissemination activities. They identified factors enabling effective involvement including team and leader commitment, named support contact, building relationships and demonstrating equality and public contributors being confident to challenge and flexible to meet researchers' timescales and work patterns. There were challenges matching resources to roles and questions about the risk of over-professionalizing public contributors. CONCLUSION: We extended our planned approach to public involvement and identified benefits to the research process that were both specific and general. We identified good practice to support effective public involvement in health services research that study teams should consider in planning and undertaking research. PUBLIC CONTRIBUTION: This paper was co-conceived, co-planned and co-authored by public contributors to contribute research evidence, based on their experiences of active involvement in the design, implementation and dissemination of a major health services research study.

A mixed-methods characterisation of patient safety incidents by primary eye care practitioners.

PURPOSE: Patient safety in eye health care is an underdeveloped field of research. A patient safety incident occurs when an unintended incident happens that could have (or did) lead to harm. To enable learning from patient safety incidents in optometry, a characterisation of commonly experienced safety incidents is needed to identify options to improve the quality of care. This study aimed to characterise eye health-related patient safety incidents from the perspective of eye care practitioners. METHODS: At a national conference in Wales, 56 eye care practitioners participated in a stakeholder workshop on eye care-related patient safety incidents. Participants were asked to suggest patient safety incidents that have occurred, or based on their experience, could occur in optometric practice. Using the nominal group technique, participants voted on the incident they perceived could cause the most harm and the incident observed most frequently in practice. Framework analysis supported identification of themes about the nature and outcomes of incidents in eye care. RESULTS: Diagnostic incidents were perceived to be the most severe (highest number of 'severity votes', n = 38), whilst administration-related incidents were most frequent (highest number of 'frequency votes' n = 39). Four themes were identified which are as follows: inappropriate clinical decision-making; delayed or missed referral of patients to general medical practitioners or ophthalmologists; compromised communication with other practitioners or patients and delays in receiving eye care. The results suggest that incidents relating to inappropriate clinical decision-making could result in the most severe harm to patients but may not occur frequently. CONCLUSIONS: Diagnostic- and administrative-related incidents pose clear challenges for improvement in quality and safety of care. The breadth of themes reflecting the nature and outcomes from unsafe eye care highlights the complexity underpinning incidents and the burden to patients. This work has informed the content of an all-Wales incident report form for primary eye care practitioners.

Designing clinical indicators for common residential aged care conditions and processes of care: the CareTrack Aged development and validation study.

BACKGROUND: People who live in aged care homes have high rates of illness and frailty. Providing evidence-based care to this population is vital to ensure the highest possible quality of life. OBJECTIVE: In this study (CareTrack Aged, CT Aged), we aimed to develop a comprehensive set of clinical indicators for guideline-adherent, appropriate care of commonly managed conditions and processes in aged care. METHODS: Indicators were formulated from recommendations found through systematic searches of Australian and international clinical practice guidelines (CPGs). Experts reviewed the indicators using a multiround modified Delphi process to develop a consensus on what constitutes appropriate care. RESULTS: From 139 CPGs, 5609 recommendations were used to draft 630 indicators. Clinical experts (n = 41) reviewed the indicators over two rounds. A final set of 236 indicators resulted, mapped to 16 conditions and processes of care. The conditions and processes were admission assessment; bladder and bowel problems; cognitive impairment; depression; dysphagia and aspiration; end of life/palliative care; hearing and vision; infection; medication; mobility and falls; nutrition and hydration; oral and dental care; pain; restraint use; skin integrity and sleep. CONCLUSIONS: The suite of CT Aged clinical indicators can be used for research and assessment of the quality of care in individual facilities and across organizations to guide improvement and to supplement regulation or accreditation of the aged care sector. They are a step forward for Australian and international aged care sectors, helping to improve transparency so that the level of care delivered to aged care consumers can be rigorously monitored and continuously improved.

Patients' experiences of attending emergency departments where primary care services are located: qualitative findings from patient and clinician interviews from a realist evaluation.

BACKGROUND: Patient experience is an important outcome and indicator of healthcare quality, and patient reported experiences are key to improving quality of care. While patient experience in emergency departments (EDs) has been reported in research, there is limited evidence about patients' specific experiences with primary care services located in or alongside EDs. We aim to identify theories about patient experience and acceptability of being streamed to a primary care clinician in an ED. METHODS: Using theories from a rapid realist review as a basis, we interviewed 24 patients and 106 staff members to generate updated theories about patient experience and acceptability of streaming to primary care services in EDs. Feedback from 56 stakeholders, including clinicians, policymakers and patient and public members, as well as observations at 13 EDs, also contributed to the development of these theories, which we present as a programme theory. RESULTS: We found that patients had no expectations or preferences for which type of clinician they were seen by, and generally found being streamed to a primary care clinician in the ED acceptable. Clinicians and patients reported that patients generally found primary care streaming acceptable if they felt their complaint was dealt with suitably, in a timely manner, and when clinicians clearly communicated the need for investigations, and how these contributed to decision-making and treatment plans. CONCLUSIONS: From our findings, we have developed a programme theory to demonstrate that service providers can expect that patients will be generally satisfied with their experience of being streamed to, and seen by, primary care clinicians working in these services. Service providers should consider the potential advantages and disadvantages of implementing primary care services at their ED. If primary care services are implemented, clear communication is needed between staff and patients, and patient feedback should be sought.