"Crack on": a qualitative study of care home managers experiences and responses to system-led setbacks during the crisis of the COVID-19 Pandemic in England.

OBJECTIVES: To explore care home managers' experiences of systems working with various organisations, including statutory, third sector and private, during the second wave of the COVID-19 pandemic from Sept 2020 to April 2021 DESIGN: An exploratory qualitative interview study using a systems theory approach focussing on the intersections of relationship interdependencies with other organisations. SETTING: Conducted remotely with care home managers and key advisors who had worked since the start of the pandemic in/with care homes for older people across the East Midlands, UK. PARTICIPANTS: 8 care home managers and 2 end-of-life advisors who participated during the second wave of the pandemic from Sept 2020. A total of 18 care home managers participated in the wider study from April 2020 to April 2021 RESULTS: Four organisational relationship interdependencies were identified: care practices, resources governance and wise working. Managers identified changes in their care practices as a shift towards the normalisation of care, with an emphasis on navigating pandemic restrictions to fit the context. Resources such as staffing, clinical reviews, pharmaceutical and equipment supplies were challenged, leading to a sense of precarity and tension. National polices and local guidance were fragmented, complex and disconnected from the reality of managing a care home. As a response a highly pragmatic reflexive style of management was identified which encompassed the use of mastery to navigate and in some cases circumvent official systems and mandates. Managers' experience of persistent and multiple setbacks were viewed as negative and confirmed their views that care homes as a sector ere marginalised by policy makers and statutory bodies. CONCLUSIONS: Interactions with various organisations shaped the ways in which care home managers responded to and sought to maximise residents and staff well-being. Some relationships dissolved over time, such as when local business and schools returned to normal obligations. Other newly formed relationships became more robust including those with other care home managers, families, and hospices. Significantly, most managers viewed their relationship with local authority and national statutory bodies as detrimental to effective working, leading to a sense of increased mistrust and ambiguity. Respect, recognition and meaningful collaboration with the care home sector should underpin any future attempts to introduce practice change in the sector.

Outcome measures from international older adult care home intervention research: a scoping review.

BACKGROUND: Care homes are increasingly important settings for intervention research to enhance evidence-informed care. For such research to demonstrate effectiveness, it is essential that measures are appropriate for the population, setting and practice contexts. OBJECTIVE: To identify care home intervention studies and describe the resident outcome measures used. DESIGN: Scoping review. METHODS: We reviewed international care home research published from 2015 to August 2022. We searched MEDLINE, EMBASE, CINAHL and ASSIA. We included any intervention study conducted in a care home, reporting resident outcomes. We extracted resident outcome measures, organised these using the domains of an adapted framework and described their use. RESULTS: From 7,330 records screened, we included 396 datasets reported in 436 publications. These included 12,167 care homes and 836,842 residents, with an average of 80 residents per study. The studies evaluated 859 unique resident outcomes 2,030 times using 732 outcome measures. Outcomes were evaluated between 1 and 112 times, with 75.1% of outcomes evaluated only once. Outcome measures were used 1-120 times, with 68.4% of measures used only once. Only 14 measures were used ≥20 times. Functional status, mood & behaviour and medications were the commonest outcome domains assessed. More than half of outcomes were assessed using scales, with a fifth using existing records or administrative data. CONCLUSIONS: There is significant heterogeneity in the choice and assessment of outcomes for intervention research in care homes. There is an urgent need to develop a consensus on useful and sensitive tools for care homes, working with residents, families and friends and staff.

Study protocol for the use of time series forecasting and risk analyses to investigate the effect of the COVID-19 pandemic on hospital admissions associated with new-onset disability and frailty in a national, linked electronic health data setting.

INTRODUCTION: Older people were at particular risk of morbidity and mortality during COVID-19. Consequently, they experienced formal (externally imposed) and informal (self-imposed) periods of social isolation and quarantine. This is hypothesised to have led to physical deconditioning, new-onset disability and frailty. Disability and frailty are not routinely collated at population level but are associated with increased risk of falls and fractures, which result in hospital admissions. First, we will examine incidence of falls and fractures during COVID-19 (January 2020-March 2022), focusing on differences between incidence over time against expected rates based on historical data, to determine whether there is evidence of new-onset disability and frailty. Second, we will examine whether those with reported SARS-CoV-2 were at higher risk of falls and fractures. METHODS AND ANALYSIS: This study uses the Office for National Statistics (ONS) Public Health Data Asset, a linked population-level dataset combining administrative health records with sociodemographic data of the 2011 Census and National Immunisation Management System COVID-19 vaccination data for England. Administrative hospital records will be extracted based on specific fracture-centric International Classification of Diseases-10 codes in years preceding COVID-19 (2011-2020). Historical episode frequency will be used to predict expected admissions during pandemic years using time series modelling, if COVID-19 had not occurred. Those predicted admission figures will be compared with actual admissions to assess changes in hospital admissions due to public health measures comprising the pandemic response. Hospital admissions in prepandemic years will be stratified by age and geographical characteristics and averaged, then compared with pandemic year admissions to assess more granular changes. Risk modelling will assess risk of experiencing a fall, fracture or frail fall and fracture, if they have reported a positive case of COVID-19. The combination of these techniques will provide insight into changes in hospital admissions from the COVID-19 pandemic. ETHICS AND DISSEMINATION: This study has approval from the National Statistician's Data Ethics Advisory Committee (NSDEC(20)12). Results will be made available to other researchers via academic publication and shared via the ONS website.

How to Conduct International Geriatric Rehabilitation Research?

With an ageing global population and an increasing focus on aging in place, the number of people in need of geriatric rehabilitation (GR) is rapidly increasing. As current GR practice is very heterogenous, cross-country comparisons could allow us to learn from each other and optimise the effectiveness of GR. However, international GR research comes with many challenges. This article summarises the facilitators and barriers relating to the recruitment of rehabilitation centres, the inclusion of patients, and data collection, as experienced by experts in the field of international GR research. The three most important methodological recommendations for conducting cross-national collaborative research in the field of GR are (1) make use of existing (inter)national networks and social media to aid recruitment of GR centres; (2) clearly define the GR treatment, setting, and patient characteristics in the inclusion criteria; and (3) use a hierarchical study structure to communicate transparently and regularly with both national and local coordinators. International GR research would greatly benefit from the implementation of a core dataset in regular GR care. Therefore, future studies should focus on developing an international consensus regarding the outcomes and corresponding cross-culturally validated measurement instruments to be used during GR.

The Careful Return of Sports Medicine Procedures in the United States During COVID-19: Comparison of Utilization, Patient Demographics, and Complications.

OBJECTIVES: Sports medicine procedures encompass some of the highest-volume elective surgeries performed annually. Elective surgery was suspended because of the severe acute respiratory syndrome coronavirus 2 (COVID-19) pandemic; therefore, the purpose was to compare temporal trends in procedural volume, patient demographics, and postoperative complications of elective sports medicine procedures in 2019 and 2020. METHODS: Using a multicenter, nationwide sample, a retrospective query of the 2019 to 2020 American College of Surgeon's National Surgery Quality Improvement Program database was conducted for all patients undergoing common elective sports medicine procedures. Temporal trends in utilization, demographics, and 30-day complications were compared pre-COVID (2019 and 2020Q1) with post-COVID (2020Q2-Q4). Linear regression was used to evaluate changes in procedural volume over time. A significance threshold of P < 0.05 was used. RESULTS: A total of 48,803 patients underwent elective surgery in 2019 (n = 27,883) and 2020 (n = 20,920), a 25.0% decline. Procedural utilization declined by 42.5% in 2020Q2 and never returned to prepandemic baseline in 2020Q3-Q4. The percentage decline in case volume from 2019 to 2020Q2 was greatest for meniscectomy (47.6%), rotator cuff repair (42.7%), labral repair (41.6%), biceps tenodesis (41.3%), and anterior cruciate ligament reconstruction (38.5%). Total complication rates were similar in 2019 (1.31%) versus 2020 (1.51%; P = 0.072). The 30-day readmission (0.74% versus 0.67%; P = 0.374), reoperation (0.35% versus 0.35%; P = 0.963), and mortality (0.01% versus 0.01%; P = 0.657) rates were similar between calendar years. CONCLUSIONS: Sports medicine procedures declined during the second quarter of 2020. Despite pandemic restrictions, patients who did undergo surgery did not experience increased complications. The present study may be used by surgeons, hospitals, and subspecialty societies to support the careful utilization of elective surgery during COVID-19. LEVEL OF EVIDENCE: III, prognostic study.

Buprenorphine Treatment Episodes During the First Year of COVID: a Retrospective Examination of Treatment Initiation and Retention.

BACKGROUND: During the COVID pandemic, overall buprenorphine treatment appeared to remain relatively stable, despite some studies suggesting a decrease in patients starting buprenorphine. There is a paucity of empirical information regarding patterns of buprenorphine treatment during the pandemic. OBJECTIVE: To better understand the patterns of buprenorphine episodes during the pandemic and how those patterns compared to pre-pandemic patterns. DESIGN: Pharmacy claims representing approximately 92% of all prescriptions filled at retail pharmacies in all 50 US states and the District of Columbia. PARTICIPANTS: Individuals filling buprenorphine prescriptions indicated for treatment of opioid use disorder. MAIN MEASURES: The number of active, starting, and ending buprenorphine treatment episodes March 13 to December 1, 2020, and the expected number of such episodes in 2020 based on the growth in treatment episodes from March 13 to December 1, 2019. KEY RESULTS: The observed number of active buprenorphine episodes in December 2020 was comparable to the expected number, but new treatment episodes starting between March 13 and December 1, 2020, were 17.2% fewer than expected based on the 2019 experience. Similarly, the number of episodes that ended between March 13 and December 1, 2020, was 16.0% fewer than expected. Decreases from expected episode starts and ends occurred throughout the period but were greatest in the 2 months after the declaration of the public health emergency. CONCLUSIONS AND RELEVANCE: Beneath the apparent stability of buprenorphine patient numbers during the pandemic, the flow of individuals receiving buprenorphine treatment changed substantially. Our findings shed light on how policy changes meant to support buprenorphine prescribing influenced prescribing dynamics during that period, suggesting that while policy efforts may have been successful in maintaining existing patients in treatment, that success did not extend to individuals not yet in treatment.

Developing a minimum data set for older adult care homes in the UK: exploring the concept and defining early core principles.

Reforms to social care in response to the COVID-19 pandemic, in the UK and internationally, place data at the heart of proposed innovations and solutions. The principles are not well established of what constitutes core, or minimum, data to support care home residents. Often, what is included privileges data on resident health over day-to-day care priorities and quality of life. This Personal View argues for evidence-based principles on which to base the development of a UK minimum data set (MDS) for care homes. Co-produced work involving care home staff and older people working with stakeholders is required to define and agree the format, content, structure, and operationalisation of the MDS. Implementation decisions will determine the success of the MDS, affecting aspects including data quality, completeness, and usability. Care home staff who collect the data need to benefit from the MDS and see value in their contribution, and residents must derive benefit from data collection and synthesis.

Clinician Perspectives on Delivering Medication Treatment for Opioid Use Disorder during the COVID-19 Pandemic: A Qualitative Evaluation.

OBJECTIVE: The coronavirus disease 2019 (COVID-19) pandemic necessitated changes in opioid use disorder care. Little is known about COVID-19's impact on general healthcare clinicians' experiences providing medication treatment for opioid use disorder (MOUD). This qualitative evaluation assessed clinicians' beliefs about and experiences delivering MOUD in general healthcare clinics during COVID-19. METHODS: Individual semistructured interviews were conducted May through December 2020 with clinicians participating in a Department of Veterans Affairs initiative to implement MOUD in general healthcare clinics. Participants included 30 clinicians from 21 clinics (9 primary care, 10 pain, and 2 mental health). Interviews were analyzed using thematic analysis. RESULTS: The following 4 themes were identified: overall impact of the pandemic on MOUD care and patient well-being, features of MOUD care impacted, MOUD care delivery, and continuance of telehealth for MOUD care. Clinicians reported a rapid shift to telehealth care, resulting in few changes to patient assessments, MOUD initiations, and access to and quality of care. Although technological challenges were noted, clinicians highlighted positive experiences, including treatment destigmatization, more timely visits, and insight into patients' environments. Such changes resulted in more relaxed clinical interactions and improved clinic efficiency. Clinicians reported a preference for in-person and telehealth hybrid care models. CONCLUSIONS: After the quick shift to telehealth-based MOUD delivery, general healthcare clinicians reported few impacts on quality of care and highlighted several benefits that may address common barriers to MOUD care. Evaluations of in-person and telehealth hybrid care models, clinical outcomes, equity, and patient perspectives are needed to inform MOUD services moving forward.

The Effect of the Coronavirus Disease 2019 (COVID-19) Pandemic on Elective Cervical Spine Surgery Utilization and Complications in the United States: A Nationwide Temporal Trends Analysis.

OBJECTIVES: As a result of the coronavirus disease 2019 (COVID-19) pandemic, elective surgeries nationwide were suspended. The objective was to compare temporal trends in patient demographics, case volumes, and postoperative complications of patients undergoing elective cervical spine surgery from pre-COVID-19 (2019-2020 Q1) to post-COVID-19 (2020 Q2-Q4). METHODS: The 2019 to 2020 American College of Surgeon's National Surgery Quality Improvement Program database was queried for common elective cervical spine surgeries. Patients pre-COVID-19 (2019-2020 Q1) were compared with those undergoing surgery during post-COVID-19 (2020 Q2-Q4) protocols. Procedural use, patient demographics, and complications were compared. Linear regression was used to evaluate case volume changes over time. P values less than 0.05 were significant. RESULTS: In total, 31,013 patients underwent elective cervical spine surgery in 2019 (N = 16,316) and 2020 (N = 14,697); an overall 10% decline. Compared with the calendar year 2019 through 2020 Q1 mean, elective surgery volume decreased by 21.6% in 2020 Q2 and never returned to prepandemic baseline. The percentage decline in case volume from 2019 to 2020 Q1 to 2020 Q2 was greatest for anterior cervical discectomy and fusion (23.3%), followed by cervical decompression (23.4%), posterior cervical fusion (15.0%), and cervical disc arthroplasty and vertebral corpectomy (13.7%). Patients undergoing surgery in 2020 Q2-Q4 had overall greater comorbidity burden (American Society of Anesthesiologists grade 3 and 4) (P < 0.001). From 2019-2020 Q1 versus 2020 Q2-Q4, there was a significant increase in total complication (5.5% vs. 6.8%, P < 0.001), reoperation (1.9% vs. 2.2%, P = 0.048), and mortality (0.25% vs. 0.37%, P = 0.049) rates. CONCLUSIONS: Elective surgery declined drastically during the second quarter of 2020. Patients undergoing surgery during the pandemic had an overall greater comorbidity burden, resulting in increased total complication and mortality rates over the study period.

Anti-racist strategies for clinical and translational research: Design, implementation, and lessons learned from a new course.

Translational research should examine racism and bias and improve health equity. We designed and implemented a course for the Master of Science in Clinical Investigation program of the Northwestern University Clinical and Translational Sciences Institute. We describe curriculum development, content, outcomes, and revisions involving 36 students in 2 years of "Anti-Racist Strategies for Clinical and Translational Science." Ninety-six percent of students reported they would recommend the course. Many reported changes in research approaches based on course content. A course designed to teach anti-racist research design is feasible and has a positive short-term impact on learners.

COVID-19 vaccine hesitancy in care home staff: A survey of Liverpool care homes.

Uptake of COVID-19 vaccine first doses in UK care homes has been higher among residents compared to staff. We aimed to identify causes of lower COVID-19 vaccine uptake amongst care home staff within Liverpool. An anonymised online survey was distributed to all care home managers, between the 21st and the 29th January 2021. 53 % of 87 care homes responded. The overall COVID-19 vaccination rate was 52.6 % (n = 1119). Reasons, identified by care home managers for staff being unvaccinated included: concerns about lack of vaccine research (37.0 %), staff being off-site during vaccination sessions (36.5 %), pregnancy and fertility concerns (5.6 %), and allergic reactions concerns (3.2 %). Care home managers wanted to tackle vaccine hesitancy through conversations with health professionals, and provision of evidence dispelling vaccine misinformation. Vaccine hesitancy and logistical issues were the main causes for reduced vaccine uptake among care home staff. The former could be addressed by targeted training, and public health communication campaigns to build confidence and acceptance of COVID-19 vaccines.

Multicenter Diagnostic Evaluation of a Novel Coronavirus Antigen Lateral Flow Test among Symptomatic Individuals in Brazil and the United Kingdom.

The COVID-19 pandemic has led to the commercialization of many antigen-based rapid diagnostic tests (Ag-RDTs), requiring independent evaluations. This report describes the clinical evaluation of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom. The collected samples (446 nasal swabs from Brazil and 246 nasopharyngeal samples from the UK) were analyzed by the Ag-RDT and compared to reverse transcription-quantitative PCR (RT-qPCR). Analytical evaluation of the Ag-RDT was performed using direct culture supernatants of SARS-CoV-2 strains from the wild-type (B.1), Alpha (B.1.1.7), Delta (B.1.617.2), Gamma (P.1), and Omicron (B.1.1.529) lineages. An overall sensitivity and specificity of 88.2% (95% confidence interval [CI], 81.3 to 93.3) and 100.0% (95% CI, 99.1 to 100.0), respectively, were obtained for the Brazilian and UK cohorts. The analytical limit of detection was determined as 1.0 × 103 PFU/mL (Alpha), 2.5 × 102 PFU/mL (Delta), 2.5 × 103 PFU/mL (Gamma), and 1.0 × 103 PFU/mL (Omicron), giving a viral copy equivalent of approximately 2.1 × 104 copies/mL, 9.0 × 105 copies/mL, 1.7 × 106 copies/mL, and 1.8 × 105 copies/mL for the Ag-RDT, respectively. Overall, while a higher sensitivity was claimed by the manufacturers than that found in this study, this evaluation finds that the Ag-RDT meets the WHO minimum performance requirements for sensitivity and specificity of COVID-19 Ag-RDTs. This study illustrates the comparative performance of the Hotgen Ag-RDT across two global settings and considers the different approaches in evaluation methods. IMPORTANCE Since the beginning of the SARS-CoV-2 pandemic, we have witnessed growing numbers of antigen rapid diagnostic tests (Ag-RDTs) being brought to market. In the United Kingdom, this was somewhat controlled indirectly as the government offered free tests from a small number of companies. However, as this has now ceased, individuals are responsible for their own acquisition of test kits. Similarly in Brazil, as of January 2022, pharmacies and other health care retailers are permitted to sell Ag-RDTs directly to the community. Many of these Ag-RDTs have not been externally evaluated, and results are not readily available to the public. Thus, there is now a need for a transparent evaluation of Ag-RDTs with both analytical and clinical evaluation. We present an independent review of the Novel Coronavirus 2019-nCoV Antigen Test (Colloidal Gold) (Beijing Hotgen Biotech Co., Ltd.), at two sites within Brazil and one in the United Kingdom.

Dietary nitrate supplementation for preventing and reducing the severity of winter infections, including COVID-19, in care homes (BEET-Winter): a randomised placebo-controlled feasibility trial.

PURPOSE: Infections cause considerable care home morbidity and mortality. Nitric oxide (NO) has broad-spectrum anti-viral, bacterial and yeast activity in vitro. We assessed the feasibility of supplementing dietary nitrate (NO substrate) intake in care home residents. METHODS: We performed a cluster-randomised placebo-controlled trial in UK residential and nursing care home residents and compared nitrate containing (400 mg) versus free (0 mg daily) beetroot juice given for 60 days. Outcomes comprised feasibility of recruitment, adherence, salivary and urinary nitrate, and ordinal infection/clinical events. RESULTS: Of 30 targeted care homes in late 2020, 16 expressed interest and only 6 participated. 49 residents were recruited (median 8 [interquartile range 7-12] per home), mean (standard deviation) age 82 (8) years, with proxy consent 41 (84%), advance directive for hospital non-admission 8 (16%) and ≥ 1 doses of COVID-19 vaccine 37 (82%). Background dietary nitrate was < 30% of acceptable daily intake. 34 (76%) residents received > 50% of juice. Residents randomised to nitrate vs placebo had higher urinary nitrate levels, median 50 [18-175] v 18 [10-50] mg/L, difference 25 [0-90]. Data paucity precluded clinical between-group comparisons; the outcome distribution was as follows: no infection 32 (67%), uncomplicated infection 0, infection requiring healthcare support 11 (23%), all-cause hospitalisation 5 (10%), all-cause mortality 0. Urinary tract infections were most common. CONCLUSIONS: Recruiting UK care homes during the COVID-19 pandemic was partially successful. Supplemented dietary nitrate was tolerated and elevated urinary nitrate. Together, infections, hospitalisations and deaths occurred in 33% of residents over 60 days. A larger trial is now required. TRIAL REGISTRATION: ISRCTN51124684. Application date 7/12/2020; assignment date 13/1/2021.

The effects of the COVID-19 pandemic on elective unicompartmental knee arthroplasty in the USA: further evidence that outpatient arthroplasty is safe and effective.

PURPOSE: In response to COVID-19, elective surgeries including unicompartmental knee arthroplasties (UKA) decreased. We aimed to quantify and compare temporal trends in utilization and complications in the calendar year 2019 (pre-pandemic) to 2020 in the USA. METHODS: The 2019 to 2020 ACS-NSQIP database was queried for patients undergoing elective UKA. Patients prior to COVID-19 (2019 and 2020 Q1) were compared to those after (2020 Q2-Q4). Case volumes, patient demographics, complications, and lengths of stay (LOS) were compared between years. Pearson's chi-square test was used to compare patient demographics. Linear regression was conducted to evaluate the change in case volumes. P values less than 0.05 were significant. RESULTS: In total, 3361 patients underwent UKA: 1880 in 2019 and 1481 in 2020. The number of outpatient UKAs increased (56.4% vs. 65.6%; p < 0.001). There was no significant difference in the volume of cases in 2019Q1 through 2020Q1 (p = 0.424). Case volumes fell by 60% in 2020Q2 compared with the average quarterly volume in 2019. Comparing 2019 to 2020, there was no significant difference in rates of total complications (2.1% vs. 2.2%; p = 0.843), minor complications (1.2% vs. 0.9%; p = 0.529), major complications (1.1% vs. 1.4%; p = 0.447), infection complications (1.0% vs. 0.8%; p = 0.652), wound complications (0.1% vs. 0.1%; p = 1.0), cardiac complications (0.0% vs. 0.1%; p = 0.111), pulmonary complications (0.1% vs. 0.2%; p = 0.473), hematology complications (0.1% vs. 0.1%; p = 1.0), renal complications (0.1% vs. 0.0%; p = 1.0), and Clavien-Dindo IV complications (0.1% vs. 0.4%; p = 0.177). CONCLUSION: UKA case volumes declined during the second quarter of 2020. A significant proportion of surgeries were transitioned outpatient, despite no change in complication rates.

The Effect of COVID-19 on Elective Total Knee Arthroplasty Utilization, Patient Comorbidity Burden, and Complications in the United States: A Nationwide Analysis.

INTRODUCTION: Total knee arthroplasty (TKA) is one of the highest volume elective procedures done nationwide. Elective surgery was suspended because of the COVID-19 pandemic. The utilization trends, comparison of patient demographics, and postoperative outcomes in 2020 have yet to be evaluated substantially. We compared temporal trends in procedural volume, patient demographics, and postoperative complications of elective TKA in 2019 and 2020. METHODS: Using a multicenter, nationwide representative sample, a retrospective query of the 2019 to 2020 American College of Surgeon's National Surgery Quality Improvement Program database was conducted for patients undergoing elective TKA. Temporal trends in utilization, demographics, and length of stay were compared pre-COVID-19 (2019 to 2020Q1) with post-COVID-19 (2020Q2 to Q4). Postoperative outcomes were compared by calendar year (2019 versus 2020). Linear regression was used to evaluate changes in procedural volume over time. A significance threshold of P < 0.05 was used. RESULTS: A total of 121,415 patients underwent elective TKA in 2019 (N = 72,002) and 2020 (N = 49,413), a 31.4% decline. The proportion of hospital-defined "outpatient" TKAs in 2020 was significantly greater than that in 2019 (41.5% versus 25.5%; P < 0.001). Elective TKA utilization declined by 65.1% in 2020Q2 and never returned to prepandemic baseline in 2020Q3 to Q4. The average length of stay was shorter in 2020 (1.56 versus 1.87 days; P < 0.001). The proportion of same-day discharge increased each quarter from 2019Q1 to Q4 (6.2% to 8.6%) to 2020Q1 to Q4 (8.7% to 17.1%). Total complication rates were similar in 2019 (4.84%) versus 2020 (4.75%); P = 0.430. The 30-day mortality (0.08% versus 0.07%; P = 0.858), revision surgery (1.0% versus 1.0%; P = 0.940), and readmission (2.8% versus 2.6%; P = 0.053) rates were no different between 2019 and 2020. CONCLUSION: Elective TKA declined during the second quarter of 2020. A large proportion of surgeries were transitioned to outpatient with rates of same-day discharge increasing over the study period, despite no change in complication, mortality, and readmission rates. Patient outcomes were not compromised despite pandemic restrictions for elective surgery. LEVEL OF EVIDENCE: Level III.

Development of a core outcome set for the evaluation of interventions to prevent COVID-19 in care homes (COS-COVID-PCARE Study).

BACKGROUND: People living in care homes have experienced devastating impact from COVID-19. As interventions to prevent the transmission of COVID-19 are developed and evaluated, there is an urgent need for researchers to agree on the outcomes used when evaluating their effectiveness. Having an agreed set of outcomes that are used in all relevant trials can ensure that study results can be compared. OBJECTIVE: The aim of the study was to develop a core outcome set (COS) for trials assessing the effectiveness of pharmacological and non-pharmacological interventions for preventing COVID-19 infection and transmission in care homes. METHODS: The study used established COS methodology. A list of candidate outcomes was identified by reviewing registered trials to evaluate interventions to prevent COVID-19 in care homes. Seventy key stakeholders participated in a Delphi survey, rating the candidate outcomes on a nine-point scale over two rounds, with the opportunity to propose additional outcomes. Stakeholders included care home representatives (n = 19), healthcare professionals (n = 20), people with personal experience of care homes (n = 7), researchers (n = 15) and others (n = 9). Outcomes were eligible for inclusion if they met an a priori threshold. A consensus meeting with stakeholders resulted in agreement of the final outcome set. RESULTS: Following the Delphi and consensus meeting, twenty-four outcomes were recommended for inclusion. These are grouped across four domains of infection, severity of illness, mortality, and 'other' (intervention specific or life impact). Due to the considerable heterogeneity between care homes, residents, and interventions, the relevance and importance of outcomes may differ between trial contexts. Intervention-specific outcomes would be included only where relevant to a given trial, thus reducing the measurement burden. CONCLUSION: Using a rapid response approach, a COS for COVID-19 prevention interventions in care homes has been developed. Future work should focus on identifying instruments for measuring these outcomes, and the interpretation and application of the COS across different trial contexts. Beyond COVID-19, the outcomes identified in this COS may have relevance to other infectious diseases in care homes, and the rapid response approach may be useful as preparation for future pandemics.

Design, Implementation, and Evolution of the Medicaid Outcomes Distributed Research Network (MODRN).

BACKGROUND: In the US, Medicaid covers over 80 million Americans. Comparing access, quality, and costs across Medicaid programs can provide policymakers with much-needed information. As each Medicaid agency collects its member data, multiple barriers prevent sharing Medicaid data between states. To address this gap, the Medicaid Outcomes Distributed Research Network (MODRN) developed a research network of states to conduct rapid multi-state analyses without sharing individual-level data across states. OBJECTIVE: To describe goals, design, implementation, and evolution of MODRN to inform other research networks. METHODS: MODRN implemented a distributed research network using a common data model, with each state analyzing its own data; developed standardized measure specifications and statistical software code to conduct analyses; and disseminated findings to state and federal Medicaid policymakers. Based on feedback on Medicaid agency priorities, MODRN first sought to inform Medicaid policy to improve opioid use disorder treatment, particularly medication treatment. RESULTS: Since its 2017 inception, MODRN created 21 opioid use disorder quality measures in 13 states. MODRN modified its common data model over time to include additional elements. Initial barriers included harmonizing utilization data from Medicaid billing codes across states and adapting statistical methods to combine state-level results. The network demonstrated its utility and addressed barriers to conducting multi-state analyses of Medicaid administrative data. CONCLUSIONS: MODRN created a new, scalable, successful model for conducting policy research while complying with federal and state regulations to protect beneficiary health information. Platforms like MODRN may prove useful for emerging health challenges to facilitate evidence-based policymaking in Medicaid programs.

The combined effect of policy changes and the covid-19 pandemic on the same day discharge and complications following total hip arthroplasty: a nationwide analysis.

INTRODUCTION: As a result of the SARS-CoV-2 (COVID-19) pandemic in 2020, elective surgeries, including total joint arthroplasty (TJA), were suspended nationwide. Concurrent removal of total hip arthroplasty (THA) from the Medicare inpatient-only list posed challenges to the delivery of quality patient care with low payor cost. Therefore, the objective of this study was to compare temporal trends in patient demographics, case volumes, length of stay, and complications following elective THA in the years 2019 to 2020 in the United States. METHODS: The 2019 to 2020 ACS-NSQIP database was queried for elective THA patients. Patients Pre-COVID (2019 and 2020Q1) were compared with post-COVID (2020Q2-Q4). THA utilization, demographics, 30-day complications, and length of stay (LOS) were compared between years. Linear regression evaluated changes in case volumes over time with significance threshold of P < 0.05. RESULTS: A total of 77,797 patients underwent elective THA in 2019 (n = 43,667) and 2020 (n = 34,130), resulting in a 24.5% decline. Outpatient THA increased in 2020 (35.6%) vs. 2019 (5.7%) (P < 0.001). There was no significant difference in the volume of cases in 2019Q1 through 2019Q4 (P = 0.984). Elective THA volumes declined by 68.8% in 2020Q2, returned to pre-pandemic baseline in 2020Q3, before leveling off at 81.5% of baseline in Q4. Average LOS was significantly shorter in 2020 (1.55 days) vs. 2019 (1.78 days) (P < 0.001) and the proportion of same day discharge (SDD) increased quarterly from 2019 to 2020. There was no significant difference in the total complication rates in 2019 (6.6%) vs. 2020 (6.6%) (P = 0.831). DISCUSSION: Elective THA precipitously declined during the second quarter of 2020. The combined effect of policy changes and the COVID-19 pandemic resulted in a seven-fold increase in the number of surgeries performed in the outpatient setting in 2020. Rates of SDD doubled over the study period, despite no change in complication rates.