Research capacity and culture among hand therapists in Australia: A cross-sectional survey.

BACKGROUND: Identifying the factors influencing engagement in research capacity and culture (RCC) in hand therapy practice is essential to inform strategies to support contributions to high-quality research and its implementation in clinical practice. However, the RCC of clinicians providing hand therapy services in Australia has not been investigated. PURPOSE: This study aimed to measure RCC among hand therapists in Australia to identify perceived barriers, motivators, and skills related to undertaking research. STUDY DESIGN: Cross-sectional survey. METHODS: All Australian Hand Therapy Association members were invited to complete the RCC tool, which includes three domains: i) individual, ii) professional group (team), and iii) organization. RESULTS: One hundred twenty-two therapists (13.6% response rate) completed the survey. Survey findings indicate that the RCC of hand therapists in Australia is relatively low across all RCC domains, with scores on these items being either moderate or low. The findings from this study suggest that the areas or skills that respondents felt most confident with were more closely aligned to the clinical skills required as evidence-based practitioners, compared to other skills more closely aligned with the clinician-researchers, such as data analysis or writing proposals. CONCLUSIONS: Hand therapists in Australia may not possess the research experience or skills required to confidently complete a range of research-related activities. Future support strategies should focus on improving hand therapist knowledge and confidence regarding common research tasks and provide funding and mentoring for additional hand therapist clinician-researcher roles.

Mental health service utilization and help seeking behaviours of adult Cambodians living in Western countries: A systematic scoping review.

BACKGROUND: Health disparity and under-utilization of health services is prevalent among Asian refugees and migrants in Western countries and can profoundly impact health outcomes. Cambodians who survived extreme physical and emotional trauma during the genocides enacted by the Khmer Rouge regime in the 1970's are particularly vulnerable to poor mental health outcomes decades later. Understanding the experiences of help-seeking and service use by displaced Cambodians in Western countries may help to design more effective and culturally safe healthcare services. AIMS: To identify characteristics or factors associated with help seeking behaviours and service utilization of displaced Cambodians with mental health issues living in Western countries. METHODS: This review followed the Arksey & O'Malley methodological framework for scoping reviews. Articles for review were identified through searches of nine electronic databases and manual searches. Relevant articles were selected, and data was extracted and synthesized into key themes. RESULTS: This review included 15 articles. Most of the studies were conducted in the USA (n = 13) with one each conducted in Canada and New Zealand. Seven studies used qualitative interviews, five used a cross-sectional survey approach, two used a mixed-methods approach and one was a narrative review and case series. Key findings highlighted the impact of Cambodian cultural beliefs about mental health (guilt, shame and help-seeking stigma) on service utilization and the disconnect between Western models of service provision and preferred Cambodian ways of receiving support. CONCLUSION: Mental health services in Western countries are likely to be under-utilized by Cambodians due to a mismatch between health beliefs and Western models of care. Further investigation of the association between health beliefs and barriers to service utilization among adult Cambodian refugees is warranted.

"Surthriving" Hand Rehabilitation: Proposing Interventions to Support Novice Occupational Therapists Working in Underserved Contexts.

Hand rehabilitation delivered to underserved South African communities is often the responsibility of novice or generalist occupational therapists. Novice therapists typically work with restricted supervision, support, and resources. Little is known about how these therapists should be supported in order to strengthen the services that they deliver. This study is aimed at understanding how novice occupational therapists in their first year of practice describe their experience of delivering hand rehabilitation in order to identify their support and development needs and propose interventions to address these needs. A qualitative instrumental case study design was used. Data were collected from novice occupational therapists (n = 9) who participated in an online community of practice. Data collection techniques included photoelicitation, facilitated reflection activities, and case discussion. Reflexive thematic analysis was employed. Trustworthiness strategies included reflexive writing, prolonged engagement, data source triangulation, member checking, and peer audit. Analysis generated three themes: (1) "submerged: I had to drown a little" captured participants' experience of being saturated by contextual features including poverty and poor basic management of hand injuries. (2) "Starting somewhere" captured participants' journey of treating patients with hand injuries. They transitioned from an initial sense of having "no idea" to developing "some idea"; their clinical reasoning was challenged when working with no diagnosis, unfamiliar presentations, or when contextual features rendered traditional approaches to therapy inappropriate. Finally, (3) "dynamics of 'surthrival'" captured elements that contributed to participants either thriving or merely surviving their hand rehabilitation experience. The proposed strategies identified in this study to address the support and development needs of novice therapists include interventions focused on systems and health services; learning opportunities to support competency and physical resources; and emotional support. Beyond application to the South African context, these strategies may be considered for supporting generalist or novice therapists delivering hand rehabilitation in other low- to middle-income countries.

Health Consequences of Climate Change: Continuing Education Opportunities for Health Professionals in the United States.

Climate change is a looming public health challenge. The health consequences of climate change are increasingly recognized as contributing to negative health outcomes for individuals, families, communities, and populations. The education of health professionals in academic programs and continuing education in clinical practice settings is critical in today's world. The Association of American Medical Colleges and the National League for Nursing, among other organizations, have urged academic programs to include the impact of climate change on health in health professions education and have started to integrate it into curricula. However, health professionals educated over the past several decades have received little content related to the deleterious impact of climate change on health. Therefore, continuing education programs addressing the health consequences of climate change are being developed to fill the gap in health professions education globally. This review study explicated the available continuing education opportunities for public health professionals and health care providers related to the health consequences of climate change. [J Contin Educ Nurs. 2023;54(12):561-566.].

Leadership in Nursing Education for Advancing a School of Nursing-Led Center for Climate Change, Climate Justice, and Health.

BACKGROUND: This article examines innovations in the development and advancement of a school of nursing-led climate change center and innovative leadership related to climate change and health in nursing education. METHOD: The integration of health consequences of climate change in curricula and continuing education is essential to prepare nursing students and nurses for clinical practice. RESULTS: Transformational leadership is a key concept for effective leadership in nursing education to address climate change as the looming public health challenge of the 21st century. Transformational leadership strengthened one nursing program's curricula, dissemination of relevant scholarship, and achievements with public health outreach related to climate change, climate justice, and health. CONCLUSION: Nursing education leaders can influence nursing practice and improve societal health outcomes related to the health consequences of climate change across all levels of education and continuing education for professional nurses. [J Nurs Educ. 2023;62(9):528-531.].

Therapeutic trials for long COVID-19: A call to action from the interventions taskforce of the RECOVER initiative.

Although most individuals recover from acute SARS-CoV-2 infection, a significant number continue to suffer from Post-Acute Sequelae of SARS-CoV-2 (PASC), including the unexplained symptoms that are frequently referred to as long COVID, which could last for weeks, months, or even years after the acute phase of illness. The National Institutes of Health is currently funding large multi-center research programs as part of its Researching COVID to Enhance Recover (RECOVER) initiative to understand why some individuals do not recover fully from COVID-19. Several ongoing pathobiology studies have provided clues to potential mechanisms contributing to this condition. These include persistence of SARS-CoV-2 antigen and/or genetic material, immune dysregulation, reactivation of other latent viral infections, microvascular dysfunction, and gut dysbiosis, among others. Although our understanding of the causes of long COVID remains incomplete, these early pathophysiologic studies suggest biological pathways that could be targeted in therapeutic trials that aim to ameliorate symptoms. Repurposed medicines and novel therapeutics deserve formal testing in clinical trial settings prior to adoption. While we endorse clinical trials, especially those that prioritize inclusion of the diverse populations most affected by COVID-19 and long COVID, we discourage off-label experimentation in uncontrolled and/or unsupervised settings. Here, we review ongoing, planned, and potential future therapeutic interventions for long COVID based on the current understanding of the pathobiological processes underlying this condition. We focus on clinical, pharmacological, and feasibility data, with the goal of informing future interventional research studies.

Excess burden of respiratory and abdominal conditions following COVID-19 infections during the ancestral and Delta variant periods in the United States: An EHR-based cohort study from the RECOVER Program.

Importance: The frequency and characteristics of post-acute sequelae of SARS-CoV-2 infection (PASC) may vary by SARS-CoV-2 variant. Objective: To characterize PASC-related conditions among individuals likely infected by the ancestral strain in 2020 and individuals likely infected by the Delta variant in 2021. Design: Retrospective cohort study of electronic medical record data for approximately 27 million patients from March 1, 2020-November 30, 2021. Setting: Healthcare facilities in New York and Florida. Participants: Patients who were at least 20 years old and had diagnosis codes that included at least one SARS-CoV-2 viral test during the study period. Exposure: Laboratory-confirmed COVID-19 infection, classified by the most common variant prevalent in those regions at the time. Main Outcomes and Measures: Relative risk (estimated by adjusted hazard ratio [aHR]) and absolute risk difference (estimated by adjusted excess burden) of new conditions, defined as new documentation of symptoms or diagnoses, in persons between 31-180 days after a positive COVID-19 test compared to persons with only negative tests during the 31-180 days after the last negative test. Results: We analyzed data from 560,752 patients. The median age was 57 years; 60.3% were female, 20.0% non-Hispanic Black, and 19.6% Hispanic. During the study period, 57,616 patients had a positive SARS-CoV-2 test; 503,136 did not. For infections during the ancestral strain period, pulmonary fibrosis, edema (excess fluid), and inflammation had the largest aHR, comparing those with a positive test to those with a negative test, (aHR 2.32 [95% CI 2.09 2.57]), and dyspnea (shortness of breath) carried the largest excess burden (47.6 more cases per 1,000 persons). For infections during the Delta period, pulmonary embolism had the largest aHR comparing those with a positive test to a negative test (aHR 2.18 [95% CI 1.57, 3.01]), and abdominal pain carried the largest excess burden (85.3 more cases per 1,000 persons). Conclusions and Relevance: We documented a substantial relative risk of pulmonary embolism and large absolute risk difference of abdomen-related symptoms after SARS-CoV-2 infection during the Delta variant period. As new SARS-CoV-2 variants emerge, researchers and clinicians should monitor patients for changing symptoms and conditions that develop after infection.

"Burnout felt inevitable": Experiences of university staff in educating the nursing and allied health workforce during the first COVID-19 waves.

Introduction: Maintaining progress in the face of looming burnout during the first 2 years of the COVID-19 pandemic was crucial for the health workforce, including those educating the next generation of health professionals. The experiences of students and healthcare practitioners have been explored to a greater degree than the experiences of university-based health professional educators. Methods: This qualitative study examined the experiences of nursing and allied health academics at an Australian University during COVID-19 disruptions in 2020 and 2021 and describes the strategies that academics and/or teams implemented to ensure course continuity. Academic staff from nursing, occupational therapy, physiotherapy, and dietetics courses at Swinburne University of Technology, Australia provided narratives regarding the key challenges and opportunities they faced. Results: The narratives highlighted the strategies generated and tested by participants amidst rapidly changing health orders and five common themes were identified: disruption; stress; stepping up, strategy and unexpected positives, lessons, and legacy impacts. Participants noted challenges related to student engagement in online learning and ensuring the acquisition of discipline-specific practical skills during periods of lock-down. Staff across all disciplines reported increased workload associated with converting teaching to on-line delivery, sourcing alternative fieldwork arrangements, and dealing with high levels of student distress. Many reflected on their own expertise in using digital tools in teaching and their beliefs about the effectiveness of distance teaching for health professional training. Ensuring students were able to complete required fieldwork hours was particularly challenging due to constantly changing public health orders and conditions and staffing shortages at health services. This was in addition to illness and isolation requirements further impacting the availability of teaching associates for specialist skills classes. Discussion: Solutions such as remote and blended learning telehealth, and simulated placements were rapidly implemented in some courses especially where fieldwork could not be rescheduled or amended at the health settings. The implications and recommendations for educating and ensuring competence development in the health workforce during times when usual teaching methods are disrupted are discussed.

Comparison of two relative motion extension approaches (RME with versus without an additional overnight orthosis) following zones V-VI extensor tendon repairs: A randomized equivalence trial.

STUDY DESIGN: Multi--center randomized controlled trial with two intervention parallel groups. An equivalence trial. INTRODUCTION: Relative motion extension (RME) orthoses are widely used in the postoperative management of finger extensor tendon repairs in zones V-VI. Variability in orthotic additions to the RME only (without a wrist orthosis) approach has not been verified in clinical studies. PURPOSE OF THE STUDY: To examine if two RME only approaches (with or without an additional overnight wrist-hand-finger orthosis) yields clinically similar outcomes. METHODS: Thirty-two adult (>18 years) participants (25 males, 7 females) were randomized to one of two intervention groups receiving either 1) a relative motion extension orthosis for day wear and an overnight wrist-hand-finger orthosis ('RME Day' group), or 2) a relative motion extension orthosis to be worn continuously ('RME 24-Hr' group); both groups for a period of four postoperative weeks. RESULTS: Using a series of linear mixed models we found no differences between the intervention groups for the primary (ROM including TAM, TAM as a percentage of the contralateral side [%TAM], and Millers Criteria) and secondary outcome measures of grip strength, QuickDASH and PRWHE scores. The models did identify several covariates that are correlated with outcome measures. The covariate 'Age' influenced TAM (P = .006) and %TAM (P = .007), with increasing age correlating with less TAM and recovery of TAM compared to the contralateral digit. 'Sex' and 'Contralateral TAM' are also significant covariates for some outcomes. DISCUSSION: With similar outcomes between both intervention groups, the decision to include an additional night orthosis should be individually tailored for patients rather than protocol-based. As the covariates of 'Age' and 'Sex' influenced outcomes, these should be considered in clinical practice. CONCLUSIONS: A relative motion extension only approach with or without an additional overnight wrist-hand-finger orthosis yielded clinically similar results whilst allowing early functional hand use, without tendon rupture.

Interventions for social and community participation for adults with intellectual disability, psychosocial disability or on the autism spectrum: An umbrella systematic review.

Objective: This umbrella systematic review examined the effectiveness, facilitators, and barriers of interventions for social, community and civic participation for adults on the autism spectrum, or with intellectual or psychosocial disability. Data Sources: Eight databases were searched to identify eligible reviews defined by the: Sample (≥50% adults on the autism spectrum or with intellectual or psychosocial disability), Phenomena of Interest (interventions in community settings that aimed to improve social, community or civic participation, or capacity to participate), Design (any), Evaluation (any method that evaluated impacts on participation or capacity to participate), and Research type (reviews as journal articles, dissertations or in grey literature, in English, published 2010-2020). Review Methods: Rapid review methods were used. One researcher screened 27,890 records and 788 potentially eligible full texts. A second reviewer independently screened 20% of records, and ambiguous full text publications. Study quality was extracted, and review quality was assessed with the Assessing Methodological Quality of Systematic Reviews (AMSTAR) checklist. Data from 522 studies in 57 eligible systematic reviews were extracted for narrative synthesis. The Corrected Covered Area (CCA) was calculated to indicate overlap between reviews. Results: There was a pooled sample of 28,154 study participants, predominantly from studies in North America, the UK and Europe. There was very low overlap between reviews (CCA = 0.3%). Reviews were predominantly low quality: 77.2% of reviews met <50% of AMSTAR criteria. Most studies were low (45.4%) or moderate (38.3%) quality. Three broad intervention categories improved participation, inclusion and belonging outcomes: (1) interventions to help people identify and connect with participation opportunities (e.g., person centred planning); (2) participation opportunities or activities (e.g., joining a community group, sports or outdoor activities, or arts-based activities); and (3) supports to build skills and capacity to participate socially and in the community. Conclusions: The evidence highlighted that improved social and community participation requires purposeful strategies that identify meaningful participation preferences (e.g., where, when, how, and with whom) and provide support to build capacity or enable ongoing participation. Community capacity building, peer support and advocacy may also be needed to make the community more accessible, and to enable people to exercise genuine choice.

Hand therapy role in return to work for patients with hand and upper limb conditions.

STUDY DESIGN: Electronic Web-based survey INTRODUCTION: Evidence supports the use of health-focused interventions combined with service coordination and work modification components to reduce the individual, community, and societal burden associated with acute and chronic musculoskeletal conditions. The levels of engagement, skill, and confidence of Australian hand therapists in assisting their patients to return to work (RTW) are currently unknown. PURPOSE OF THE STUDY: To identify current practices, skill, and the need for additional training in management of the RTW process from a sample of Australian hand therapists. METHODS: An electronic survey was sent to current members of the Australian Hand Therapy Association. Data collected included training and/or professional experience, caseload and/or workplace, scope of and barriers to vocational practice, and satisfaction with own contribution to the RTW process for patients. RESULTS: A total of 99 individual responses (12.4% of total membership) were included, with most indicating a limited role in the RTW process. Only 52.7% said they regularly monitored and adjusted their patients' RTW program. Most plans were informed by formal tests of underlying body structure and function components rather than the patient's ability to perform of a specific work role or task. Median satisfaction with the quality of RTW service they provided was 6 of 10, with 42% scoring ≤ 5 of 10, indicating considerable scope for improvement. CONCLUSIONS: Practice patterns are described for planning and monitoring RTW, and these did not always align with the evidence-base. Further exploration of clinician barriers to implementing RTW interventions is warranted, as is upskilling for those indicating a lack of confidence in this field.

The effect of transferring weekend physical therapy services from the acute to sub-acute setting in patients following hip and knee arthroplasty: a quasi-experimental study.

BACKGROUND: Weekend physical therapy services in the acute and/or sub-acute setting may optimize postoperative recovery following hip and knee arthroplasty, though evidence supporting these services is limited. PURPOSE: To explore the change in patient and service outcomes of transferring a weekend physical therapy service from the acute to the sub-acute setting following hip and knee arthroplasty. METHODS: This was a quasi-experimental research design nested within two stepped-wedge cluster randomized controlled trials. Acute weekend physical therapy services were sequentially discontinued and reallocated to the sub-acute setting in a random order from one ward at a time within the broader trial. Patient and service outcomes for participants 6 weeks following hip and knee arthroplasty (N = 247) were compared during 6 months of acute weekend physical therapy services (Phase 1, n = 117) followed by 6 months of sub-acute services (Phase 2, n = 130). Intention-to-treat statistical analyses were conducted. RESULTS: The intervention had a negligible effect on medium-term outcomes. The only statistically significant difference observed was slightly higher ratings of "worst pain experienced over the past week" [coefficient 0.865 (0.123 to 1.606), p = .022] during Phase 2. No interaction effects were observed despite a 2.4-day reduction in length of stay amongst complex patients during Phase 2 (18.28 and 15.86 days in Phase 1 and 2, respectively). CONCLUSIONS: No comparative advantage or disadvantage was observed by reallocating a weekend physical therapy budget from the acute to sub-acute setting following hip and knee arthroplasty. Further research investigating the cost-effectiveness of these services in the sub-acute setting may be warranted for complex patients.

Moving Past the Loss: A Longitudinal Qualitative Study of Health Care Staff Experiences of Disinvestment.

This longitudinal qualitative study examines staff experience of disinvestment from a service they are accustomed to providing to their patients. It took place alongside a disinvestment trial that measured the impact of the removal of weekend allied health services from acute wards at two hospitals. Data were gathered from repeated interviews and focus groups with 450 health care staff. We developed a grounded theory, which explains changes in staff perceptions over time and the key modifying factors. Staff appeared to experience disinvestment as loss; a key difference to other operational changes. Early staff experiences of disinvestment were primarily negative, but evolved with time and change-management strategies such as the provision of data, clear and persistent communication approaches, and forums where the big picture context of the disinvestment was robustly discussed. These allowed the disinvestment trial to be successfully implemented at two health services, with high compliance with the research protocol.

The Effectiveness of Multicomponent Functional Maintenance Initiatives for Acutely Hospitalized Older Adults: A Systematic Review and Meta-analysis.

BACKGROUND AND PURPOSE: To evaluate the effectiveness of multicomponent functional maintenance initiatives (MFMIs) on functional outcomes and adverse events associated with functional decline among acutely hospitalized older adults. DATA SOURCES: Studies were sourced from OVID Medline, PubMed, Embase, CINAHL, the Cochrane Library, and PEDro databases from inception to April 15, 2020, and their bibliographies. STUDY SELECTION: Randomized controlled trials were included if they investigated multicomponent interventions comprising more than one nonpharmacological intervention targeting physical functional decline and another shared risk factor for geriatric syndromes in acutely hospitalized medical or nonelective surgical patients 65 years and older. DATA EXTRACTION: Two reviewers independently assessed for eligibility, extracted data, and conducted risk of bias assessments. DATA SYNTHESIS: Eight studies involving 5534 patients were included. Multicomponent functional maintenance initiatives did not appear to confer significant effects on functional status, length of stay, or 30-day hospital readmissions; however, clinical heterogeneity limited meta-analysis for some specific functional outcomes. Patients who did not receive MFMIs were more likely to be discharged to a nursing staff facility (odds ratio = 1.53; 95% confidence interval, 1.23 to 1.90). No effect of MFMI on all-cause mortality was observed, and adverse events were rare and unlikely attributed to nonpharmacological interventions. CONCLUSIONS: Data from a small number of studies suggest MFMIs reduce the likelihood of discharge to a nursing staff facility in acutely hospitalized older adults; however, this effect may not be driven via improvements in physical function. Standardized evaluation methods to determine MFMI effectiveness appear indicated to assist decision-making regarding their implementation in clinical practice.

Disinvestment in the presence of uncertainty: Description of a novel, multi-group, disinvestment trial design and protocol for an application to reduce or cease use of mobilisation alarms for preventing falls in hospitals.

Disinvestment is the removal or reduction of previously provided practices or services, and has typically been undertaken where a practice or service has been clearly shown to be ineffective, inefficient and/or harmful. However, practices and services that have uncertain evidence of effectiveness, efficiency and safety can also be considered as candidates for disinvestment. Disinvestment from these practices and services is risky as they may yet prove to be beneficial if further evidence becomes available. A novel research approach has previously been described for this situation, allowing disinvestment to take place while simultaneously generating evidence previously missing from consideration. In this paper, we describe how this approach can be expanded to situations where three or more conditions are of relevance, and describe the protocol for a trial examining the reduction and elimination of use of mobilisation alarms on hospital wards to prevent patient falls. Our approach utilises a 3-group, concurrent, non-inferiority, stepped wedge, randomised design with an embedded parallel, cluster randomised design. Eighteen hospital wards with high rates of alarm use (≥3%) will be paired within their health service and randomly allocated to a calendar month when they will transition to a "Reduced" (<3%) or "Eliminated" (0%) mobilisation alarm condition. Dynamic randomisation will be used to determine which ward in each pair will be allocated to either the reduced or eliminated condition to promote equivalence between wards for the embedded parallel, cluster randomised component of the design. A project governance committee will set non-inferiority margins. The primary outcome will be rates of falls. Secondary clinical, process, safety, and economic outcomes will be collected and a concurrent economic evaluation undertaken.

Effectiveness of knowledge brokering and recommendation dissemination for influencing healthcare resource allocation decisions: A cluster randomised controlled implementation trial.

BACKGROUND: Implementing evidence into clinical practice is a key focus of healthcare improvements to reduce unwarranted variation. Dissemination of evidence-based recommendations and knowledge brokering have emerged as potential strategies to achieve evidence implementation by influencing resource allocation decisions. The aim of this study was to determine the effectiveness of these two research implementation strategies to facilitate evidence-informed healthcare management decisions for the provision of inpatient weekend allied health services. METHODS AND FINDINGS: This multicentre, single-blinded (data collection and analysis), three-group parallel cluster randomised controlled trial with concealed allocation was conducted in Australian and New Zealand hospitals between February 2018 and January 2020. Clustering and randomisation took place at the organisation level where weekend allied health staffing decisions were made (e.g., network of hospitals or single hospital). Hospital wards were nested within these decision-making structures. Three conditions were compared over a 12-month period: (1) usual practice waitlist control; (2) dissemination of written evidence-based practice recommendations; and (3) access to a webinar-based knowledge broker in addition to the recommendations. The primary outcome was the alignment of weekend allied health provision with practice recommendations at the cluster and ward levels, addressing the adoption, penetration, and fidelity to the recommendations. The secondary outcome was mean hospital length of stay at the ward level. Outcomes were collected at baseline and 12 months later. A total of 45 clusters (n = 833 wards) were randomised to either control (n = 15), recommendation (n = 16), or knowledge broker (n = 14) conditions. Four (9%) did not provide follow-up data, and no adverse events were recorded. No significant effect was found with either implementation strategy for the primary outcome at the cluster level (recommendation versus control ß 18.11 [95% CI -8,721.81 to 8,758.02] p = 0.997; knowledge broker versus control ß 1.24 [95% CI -6,992.60 to 6,995.07] p = 1.000; recommendation versus knowledge broker ß -9.12 [95% CI -3,878.39 to 3,860.16] p = 0.996) or ward level (recommendation versus control ß 0.01 [95% CI 0.74 to 0.75] p = 0.983; knowledge broker versus control ß -0.12 [95% CI -0.54 to 0.30] p = 0.581; recommendation versus knowledge broker ß -0.19 [-1.04 to 0.65] p = 0.651). There was no significant effect between strategies for the secondary outcome at ward level (recommendation versus control ß 2.19 [95% CI -1.36 to 5.74] p = 0.219; knowledge broker versus control ß -0.55 [95% CI -1.16 to 0.06] p = 0.075; recommendation versus knowledge broker ß -3.75 [95% CI -8.33 to 0.82] p = 0.102). None of the control or knowledge broker clusters transitioned to partial or full alignment with the recommendations. Three (20%) of the clusters who only received the written recommendations transitioned from nonalignment to partial alignment. Limitations include underpowering at the cluster level sample due to the grouping of multiple geographically distinct hospitals to avoid contamination. CONCLUSIONS: Owing to a lack of power at the cluster level, this trial was unable to identify a difference between the knowledge broker strategy and dissemination of recommendations compared with usual practice for the promotion of evidence-informed resource allocation to inpatient weekend allied health services. Future research is needed to determine the interactions between different implementation strategies and healthcare contexts when translating evidence into healthcare practice. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry ACTRN12618000029291.

Population Pharmacokinetics and Pharmacodynamics of the Neutralizing Antibodies Bamlanivimab and Etesevimab in Patients With Mild to Moderate COVID-19 Infection.

Bamlanivimab and etesevimab are neutralizing antibodies indicated for treatment of coronavirus disease 2019 (COVID-19) in patients with early mild or moderate disease. We present the use of pharmacokinetic/pharmacodynamic (PK/PD) modeling that characterizes the timecourse of viral load obtained from 2,970 patients from 2 phase II clinical trials. The model was used for identification of optimal doses that would result in at least 90% of patients achieving serum drug concentrations that result in 90% of maximum drug effect (IC90) for at least 28 days. The serum IC90 (95% confidence interval) was estimated to be 4.2 (3.2-4.3) µg/mL for bamlanivimab and 12.6 (9.7-12.8) µg/mL for etesevimab. Observed clinical trial data confirmed PK and PK/PD model predictions that doses of 700 mg bamlanivimab and 1,400 mg etesevimab would result in maximum reduction in viral load, with no additional effect seen at higher doses. No dose adjustment is recommended as age, sex, race, baseline viral load, and hepatic impairment did not have a significant impact on the PK of the antibodies. Earlier drug administration resulted in greater reductions in viral load, demonstrating the importance of receiving treatment as soon as possible. Relative to placebo, typical reduction in viral load over a 7-day period was estimated to be 80 or 93% (drug administered 4 days or 1 day after the onset of symptoms, respectively), P < 0.0001. PK/PD modeling and simulation was pivotal throughout the drug development and emergency use authorization process.

Cartilage Restoration of Bipolar Lesions Within the Patellofemoral Joint Delays Need for Arthroplasty: A Systematic Review of Rates of Failure.

PURPOSE: The purpose of the present review is to systematically review the available literature for failure rates and complications of cartilage restoration of bipolar chondral defects in the patellofemoral (PF) joint to assess the ability to treat these lesions without arthroplasty. METHODS: PubMed and MEDLINE databases were queried between 2000 to 2020 using the keywords "osteochondral" and "knee" and "microfracture," "autologous chondrocyte implantation (ACI)," or "transplantation." Patient selection included patients with bipolar chondral lesions of the patellofemoral joint that were treated with cartilage restoration procedures. Treatment of PF joints were reviewed for surgical indications/technique, rates of failure, defect characteristics, and time to failure. For the purposes of this study, failure was defined by each individual author on their respective studies. RESULTS: After screening 1,295 articles, there were 8 publications analyzed quantitatively and 10 articles analyzed both quantitatively and qualitatively. A total of 249 knees involved bipolar lesions of the patellofemoral joint. The weighted average age was 36.5 ± 10.4 years, and weighted average follow-up was 89.0 ± 31.7 months. There were failures in 0% to 50% of cases, revision procedures in 0% to 10% of cases, conversion to arthroplasty in in 0% to 50% of cases, and unsatisfactory outcome without revision in 0% to 8.3% of cases. The range in average failure rate was 0% to 50.0% (I2 = 68.0%), whereas the range in average time to failure was 2.9 to 6.8 years (I2 = 79.0%). CONCLUSION: From the available data, established cartilage restoration procedures may provide favorable patient-reported function, avoidance of secondary surgery, and joint preservation in at least 80% of patients at short- to mid-term follow-up. LEVEL OF EVIDENCE: Level IV, systematic review of Level IV studies.

Cartilage Restoration for Tibiofemoral Bipolar Lesions Results in Promising Failure Rates: A Systematic Review.

PURPOSE: The purpose of the present study is to systematically review the available literature for management of bipolar lesions within the tibiofemoral joint and determine whether tibiofemoral cartilage restoration is an effective treatment modality. METHODS: PubMed and MEDLINE databases were queried between 2000 and 2020 using the following keywords: "osteochondral" and "knee" and "microfracture," "autologous chondrocyte implantation (ACI)," or "transplantation." Articles were reviewed for the presence of a bipolar or "kissing" tibiofemoral lesion and reported lesion size, concomitant procedures, failure rates, and time to failure. RESULTS: After screening 1,295 articles, there were 4 articles available for analysis and a total of 152 knees involving the management of bipolar tibiofemoral lesions. Age ranged from 14 to 60 years, and mean follow-up was between 12 and 240 months. There was 1 retrospective cohort study (36 knees) and 3 case series (mean, 38.7 ± 17.5 knees). There were 58 knees treated with bipolar osteochondral allograft (OCA) transplantation, 58 knees treated with bipolar ACI, 20 knees treated with femoral OCA and tibial debridement, and 16 knees treated with femoral OCA and tibial microfracture. There were 37 failures (24.3%): 16 patients (10.5%) were converted to unicompartmental or total knee arthroplasty, 4 restorative procedures (2.6%) were revised, and 8 patients (1.6%) had unsatisfactory outcomes only. The remaining 15 failures (9.9%) had an unspecified combination of objective failure. The mean rate of failure ranged between 0% and 44.1% (I 2 = 83.2%). The mean time to failure ranged between 2.7 and 4.1 years (I 2 = 79.1%). CONCLUSIONS: Cartilage restoration, through both ACI and OCA, had failure rates between 0% and 44% in patients with bipolar lesions of the tibiofemoral compartment. Although a higher level of evidence is required to prove efficacy, the current study demonstrates midterm survivorship rates between 55% and 100%, which may delay the need for secondary arthroplasty. LEVEL OF EVIDENCE: Level IV, systematic review of Level IV studies.

Evaluating clinical impact of a shortened infusion duration for ramucirumab: a model-based approach.

PURPOSE: We investigated the impact of infusion duration (30 and 60 min) on the pharmacokinetic profile of ramucirumab using a population pharmacokinetic (PopPK) modeling approach. We also assessed the relationship between infusion rate and incidence of immediate infusion-related reactions (IRRs; occurring on the day of administration) using ramucirumab phase II/III study data. METHODS: The impact of different infusion durations (30 vs. 60 min) on the time-course of ramucirumab concentration profiles were evaluated using a PopPK model, established using ramucirumab pharmacokinetic data from 2522 patients. Logistic regression was used to evaluate the association between ramucirumab infusion rate and incidence of immediate IRRs in clinical trials. RESULTS: Ramucirumab time-course concentration profiles were equivalent following a 30- or 60-min infusion. In the pooled clinical study dataset, 254 of 3216 (7.9%) patients receiving ramucirumab experienced at least one immediate IRR (any grade). When grouped according to infusion rate quartile, the incidence of immediate IRRs (any grade or grade ≥ 3) was similar across quartiles; findings were confirmed in sensitivity analyses. The risk of immediate IRRs was not found to be associated with infusion rate based on multivariate logistic analysis. CONCLUSION: Shortening the infusion duration of ramucirumab from 60 to 30 min has no impact on ramucirumab exposure. Analysis of trial data found no relationship between an increased risk of immediate IRRs and a faster infusion rate. Such a change in infusion duration is unlikely to affect the clinical efficacy or overall safety profile of ramucirumab.