Research ethics review during the COVID-19 pandemic: An international study.

Research ethics review committees (ERCs) worldwide faced daunting challenges during the COVID-19 pandemic. There was a need to balance rapid turnaround with rigorous evaluation of high-risk research protocols in the context of considerable uncertainty. This study explored the experiences and performance of ERCs during the pandemic. We conducted an anonymous, cross-sectional, global online survey of chairs (or their delegates) of ERCs who were involved in the review of COVID-19-related research protocols after March 2020. The survey ran from October 2022 to February 2023 and consisted of 50 items, with opportunities for descriptive responses to open-ended questions. Two hundred and three participants [130 from high-income countries (HICs) and 73 from low- and middle-income countries (LMICs)] completed our survey. Respondents came from diverse entities and organizations from 48 countries (19 HICs and 29 LMICs) in all World Health Organization regions. Responses show little of the increased global funding for COVID-19 research was allotted to the operation of ERCs. Few ERCs had pre-existing internal policies to address operation during public health emergencies, but almost half used existing guidelines. Most ERCs modified existing procedures or designed and implemented new ones but had not evaluated the success of these changes. Participants overwhelmingly endorsed permanently implementing several of them. Few ERCs added new members but non-member experts were consulted; quorum was generally achieved. Collaboration among ERCs was infrequent, but reviews conducted by external ERCs were recognized and validated. Review volume increased during the pandemic, with COVID-19-related studies being prioritized. Most protocol reviews were reported as taking less than three weeks. One-third of respondents reported external pressure on their ERCs from different stakeholders to approve or reject specific COVID-19-related protocols. ERC members faced significant challenges to keep their committees functioning during the pandemic. Our findings can inform ERC approaches towards future public health emergencies. To our knowledge, this is the first international, COVID-19-related study of its kind.

The effects of plantarflexor weakness and reduced tendon stiffness with aging on gait stability.

Falls among older adults are a costly public health concern. Such falls can be precipitated by balance disturbances, after which a recovery strategy requiring rapid, high force outputs is necessary. Sarcopenia among older adults likely diminishes their ability to produce the forces necessary to arrest gait instability. Age-related changes to tendon stiffness may also delay muscle stretch and afferent feedback and decrease force transmission, worsening fall outcomes. However, the association between muscle strength, tendon stiffness, and gait instability is not well established. Given the ankle's proximity to the onset of many walking balance disturbances, we examined the relation between both plantarflexor strength and Achilles tendon stiffness with walking-related instability during perturbed gait in older and younger adults-the latter quantified herein using margins of stability and whole-body angular momentum including the application of treadmill-induced slip perturbations. Older and younger adults did not differ in plantarflexor strength, but Achilles tendon stiffness was lower in older adults. Among older adults, plantarflexor weakness associated with greater whole-body angular momentum following treadmill-induced slip perturbations. Weaker older adults also appeared to walk and recover from treadmill-induced slip perturbations with more caution. This study highlights the role of plantarflexor strength and Achilles tendon stiffness in regulating lateral gait stability in older adults, which may be targets for training protocols seeking to minimize fall risk and injury severity.

The Conceptualization and Measurement of Research Impact in Primary Health Care: Protocol for a Rapid Scoping Review.

BACKGROUND: The generation of research evidence and knowledge in primary health care (PHC) is crucial for informing the development and implementation of interventions and innovations and driving health policy, health service improvements, and potential societal changes. PHC research has broad effects on patients, practices, services, population health, community, and policy formulation. The in-depth exploration of the definition and measures of research impact within PHC is essential for broadening our understanding of research impact in the discipline and how it compares to other health services research. OBJECTIVE: The objectives of the study are (1) to understand the conceptualizations and measures of research impact within the realm of PHC and (2) to identify methodological frameworks for evaluation and research impact and the benefits and challenges of using these approaches. The forthcoming review seeks to guide future research endeavors and enhance methodologies used in assessing research impact within PHC. METHODS: The protocol outlines the rapid review and environmental scan approach that will be used to explore research impact in PHC and will be guided by established frameworks such as the Canadian Academy of Health Sciences Impact Framework and the Canadian Health Services and Policy Research Alliance. The rapid review follows scoping review guidelines (PRISMA-ScR; Preferred Reporting Items for Systematic Review and Meta-Analysis Extension for Scoping Reviews). The environmental scan will be done by consulting with professional organizations, academic institutions, information science, and PHC experts. The search strategy will involve multiple databases, citation and forward citation searching, and manual searches of gray literature databases, think tank websites, and relevant catalogs. We will include gray and scientific literature focusing explicitly on research impact in PHC from high-income countries using the World Bank classification. Publications published in English from 1978 will be considered. The collected papers will undergo a 2-stage independent review process based on predetermined inclusion criteria. The research team will extract data from selected studies based on the research questions and the CRISP (Consensus Reporting Items for Studies in Primary Care) protocol statement. The team will discuss the extracted data, enabling the identification and categorization of key themes regarding research impact conceptualization and measurement in PHC. The narrative synthesis will evolve iteratively based on the identified literature. RESULTS: The results of this study are expected at the end of 2024. CONCLUSIONS: The forthcoming review will explore the conceptualization and measurement of research impact in PHC. The synthesis will offer crucial insights that will guide subsequent research, emphasizing the need for a standardized approach that incorporates diverse perspectives to comprehensively gauge the true impact of PHC research. Furthermore, trends and gaps in current methodologies will set the stage for future studies aimed at enhancing our understanding and measurement of research impact in PHC. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): PRR1-10.2196/55860.

Disordered eating behaviours and basic psychological need satisfaction: the mediating role of anxiety symptoms in preadolescents.

Objective: According to self-determination theory, satisfied basic psychological needs can be a protective factor for psychopathology, including eating disorders and anxiety symptomatology. However, most research has focused on adolescent and adult populations, with less work examining perceived basic psychological need satisfaction from parents in younger samples who report anxiety and disordered eating. This cross-sectional study aimed to investigate whether basic psychological need satisfaction from parents was associated with disordered eating in preadolescents and whether anxiety mediated this relation.Method: A total of 211 preadolescents were recruited from primary schools across south Wales (mean age = 10.27 years, age range = 9-11 years; 49.3% female). Children completed self-report questionnaires on their basic psychological need satisfaction when with parents, as well as disordered eating and anxiety symptoms.Results: It was found that higher needs satisfaction was associated with lower disordered eating and anxiety, with stronger relations found in girls compared with boys. Furthermore, anxiety was found to mediate this relationship.Conclusions: Results suggest that basic psychological needs satisfaction may play an important role in the early emergence of co-occurring disordered eating and anxiety symptoms in boys and girls. The importance of considering anxiety symptoms in future work investigating needs satisfaction in the context of disordered eating and eating disorders is discussed.

In vitro assays to evaluate CAR-T cell cytotoxicity.

This chapter introduces four commonly used in vitro chimeric antigen receptor (CAR)-T cell cytotoxicity assays (lactate dehydrogenase release assay, 51Cr release assay, IncuCyte live cell killing assay, and xCELLigence real-time analysis) and provides a detailed protocol for xCELLigence real-time analysis. Focusing on in vitro assays, this chapter starts with explaining the mechanisms and discussing the utilization of each assay to quantify T-cell-induced cytotoxicity. Due to the high-throughput quantification and straightforward workflow of xCELLigence real-time analysis, a protocol entailing reagents and equipment, a 3-day step-by-step procedure, and instructions for data analysis are provided.

Exploring the presence and impact of sensory differences in children with Developmental Coordination Disorder.

BACKGROUND: Children with Developmental Coordination Disorder (DCD) can experience sensory differences. There has been limited exploration of these differences and their impact on children with DCD. AIMS: i) To explore the presence and impact of sensory differences in children with DCD compared to children without DCD; ii) To examine whether sensory differences are related to motor ability, attention deficit hyperactivity disorder (ADHD), or autistic traits. METHOD: Parents of children (8-12 years) with (n = 23) and without (n = 33) DCD used standardised questionnaires to report on their children's sensory differences, autistic traits, and ADHD traits. Motor abilities were assessed through the Movement Assessment Battery for Children-2. Data were explored both categorically (between-groups) and dimensionally. RESULTS: Children with DCD had significantly higher levels of sensory differences than children without DCD. Sensory differences also had a significantly greater impact on daily activities for children with DCD. Higher levels of ADHD and autistic traits, but not motor ability, were significant independent predictors of higher levels of sensory difference. CONCLUSION: Children with DCD experience high levels of sensory differences, which impact on their daily lives. These sensory differences may be a marker for additional neurodivergence in children with DCD. Practitioners should consider the sensory needs of children with DCD. WHAT THIS PAPER ADDS: This paper provides insight into the sensory features of children with DCD and the impact that sensory differences can have on daily living. Using parent-report, we found that children with DCD had increased sensory differences relative to children without DCD. These included increased hyperresponsiveness, increased hyporesponsiveness, and increased sensory interests, repetitions, and seeking behaviours (SIRS). We also found that sensory differences had a greater impact on daily living for children with DCD compared to children without DCD. Across the whole sample, autistic traits predicted hyperresponsivity and hyporesponsivity patterns; whereas traits of hyperactivity and impulsivity predicted SIRS. Motor abilities did not uniquely predict sensory differences, suggesting that other traits of neurodivergence may contribute to the sensory differences in DCD. Taken together, these findings highlight the necessity of considering sensory needs when supporting children with DCD. They also suggest that if sensory differences are identified in children with DCD, it may be due to the presence of co-occurring neurodivergent traits or conditions.

Associations between disordered eating, internalizing symptoms, and behavioral and neural correlates of response inhibition in preadolescence.

Response inhibition difficulties are reported in individuals with eating disorders (EDs), anxiety, and depression. Although ED symptoms and internalizing symptoms co-occur in preadolescence, there is limited research examining associations between these symptoms and response inhibition in this age group. This study is the first to investigate the associations between behavioral and neural markers of response inhibition, disordered eating (DE), and internalizing symptoms in a community sample of preadolescents. Forty-eight children (M age = 10.95 years, 56.3% male) completed a Go/NoGo task, whereas electroencephalography was recorded. Self-report measures of DE and internalizing symptoms were collected. Higher levels of anxiety and depression were associated with neural markers of suboptimal response inhibition (attenuated P3NoGo amplitudes) in preadolescence. In contrast, higher levels of depression were associated with greater response inhibition at a behavioral level. These findings suggest internalizing symptoms in preadolescence are associated with P3-indexed difficulties in evaluation and monitoring, but these are not sufficient to disrupt behavioral performance on a response inhibition task. This pattern may reflect engagement of compensatory processes to support task performance. DE was not significantly associated with response inhibition, suggesting that difficulties in response inhibition may only be reliably observed in more chronic and severe DE and ED presentations.

The Severity of Initial Unilateral Cleft Lip and Nasal Deformity Predicts Long-Term Postoperative Esthetic Outcome.

BACKGROUND: Infantile cleft lip and nasal severity influence the final esthetic result of the repair. Although various authors have described methods of cleft lip and nasal repair, there is a paucity of data that correlates cleft severity with esthetic outcomes. The aim of this study was to examine the correlation between presurgical severity of unilateral cleft deformity and long-term postoperative esthetic outcomes. METHODS: This retrospective study, based at a single institution, investigated patients with complete unilateral cleft lip, with or without cleft palate, who underwent repair by a single surgeon, had preoperative infantile facial casts, and had postoperative facial photographs at 6 to 11 years of age (N=31). Preoperative nostril width ratio and columellar angle measurements were taken from facial casts. Postoperative, long-term nasolabial appearance was rated by 5 blinded observers used a modified Kuijpers-Jagtman scale. Linear regression was used to determine the relationship between preoperative cleft severity and postoperative ratings. RESULTS: Preoperative nostril width ratio directly correlated with postoperative nasal form score (r=0.40; P=0.026); likewise, preoperative columellar angle predicted postoperative nasal form score (r=0.37; P=0.040). Preoperative cleft severity was not significantly correlated with vermillion border appearance. Cronbach α values of 0.91 (nasal form) and 0.79 (vermillion border) indicated good inter-rater reliability. Kappa values of 0.87 (nasal form) and 0.70 (vermillion border) indicated good intrarater reliability. CONCLUSIONS: Preoperative unilateral cleft nose severity directly correlates with long-term postoperative nasal appearance in childhood. Outcome studies should present and control for preoperative severity to allow more accurate assessment of repair techniques.

Functional and oncologic outcomes of prostate capsule-sparing radical cystectomy: A systematic review and meta-analysis.

Radical cystectomy (RC) is the gold standard treatment for patients with organ-confined bladder cancer. However, despite the success of this treatment, many men who undergo orthotopic neobladder substitution develop significant erectile dysfunction and urinary symptoms, including daytime and nighttime urinary incontinence. Prostate-capsule-sparing radical cystectomy (PCS-RC) with orthotopic neobladder (ONB) has been described in the literature as a surgical technique to improve functional outcomes in appropriately selected patients. We performed a systematic review and meta-analysis of manuscripts on PCS-RC with ONB published after 2000. We included retrospective and prospective studies with more than 25 patients and compared PCS-RC with nerve-sparing or conventional RC. Studies in which the entire prostate was spared (including the transitional zone) were excluded. Comparative studies were analyzed to assess rates of daytime continence, nighttime continence, and satisfactory erectile function in patients undergoing PCS-RC compared with those undergoing conventional RC. Fourteen reports were included in the final review. Our data identify high rates of daytime (83%-97%) and nighttime continence (60%-80%) in patients undergoing PCS-RC with ONB. In comparative studies, meta-analysis results demonstrate no difference in daytime continence (RR:1.12; 95% CI: 0.72-1.73) in those undergoing PCS-RC compared to those undergoing conventional RC. Similarly, nighttime continence was similar between the 2 groups (RR:1.85; 95% CI: 0.57-6.00. Erectile function was improved in those undergoing PCS-RC (RR 5.35; 95% CI: 1.82-15.74) in the PCS-RC series. Bladder cancer margin positivity and recurrence rates were similar to those reported in the literature with conventional RC with an average weighted follow-up of 52.2 months. While several studies utilized different prostate cancer (CaP) screening techniques, the rates of CaP were low (incidence 0.02; 95% CI:0.01-0.04), and oncologic outcomes were similar to standard RC. PCS-RC is associated with improved nighttime continence and erectile function compared to conventional RC techniques. Further work is needed to standardize CaP screening before surgery, but the data suggest low rates of CaP with similar oncologic outcomes when compared to RC.

Equine Embryonic Stem Cell-Derived Tenocytes are Insensitive to a Combination of Inflammatory Cytokines and Have Distinct Molecular Responses Compared to Primary Tenocytes.

Tissue fibrosis following tendon injury is a major clinical problem due to the increased risk of re-injury and limited treatment options; however, its mechanism remains unclear. Evidence suggests that insufficient resolution of inflammation contributes to fibrotic healing by disrupting tenocyte activity, with the NF-κB pathway being identified as a potential mediator. Equine embryonic stem cell (ESC) derived tenocytes may offer a potential cell-based therapy to improve tendon regeneration, but how they respond to an inflammatory environment is largely unknown. Our findings reveal for the first time that, unlike adult tenocytes, ESC-tenocytes are unaffected by IFN-γ, TNFα, and IL-1ß stimulation; producing minimal changes to tendon-associated gene expression and generating 3-D collagen gel constructs indistinguishable from unstimulated controls. Inflammatory pathway analysis found these inflammatory cytokines failed to activate NF-κB in the ESC-tenocytes. However, NF-κB could be activated to induce changes in gene expression following stimulation with NF-κB pharmaceutical activators. Transcriptomic analysis revealed differences between cytokine and NF-κB signalling components between adult and ESC-tenocytes, which may contribute to the mechanism by which ESC-tenocytes escape inflammatory stimuli. Further investigation of these molecular mechanisms will help guide novel therapies to reduce fibrosis and encourage superior tendon healing.

A single-armed proof-of-concept study of Lymfit: A personalized, virtual exercise intervention to improve health outcomes in lymphoma survivors in the pandemic.

BACKGROUND AND OBJECTIVE: Treatments of lymphoma can lead to reduced physical functioning, cancer-related fatigue, depression, anxiety, and insomnia. These side effects can negatively impact the cancer survivor's quality of life. Mounting evidence indicates that physical activities are highly therapeutic in mitigating the short- and long-term side effects of cancer treatments. Yet, lymphoma survivors' participation in physical activities remains suboptimal, which has been further exacerbated by the deleterious effects of isolation during the COVID-19 pandemic. The Lymfit intervention aims to offer motivational support, expert guidance, and a personalized exercise prescription to optimize physical activities among lymphoma survivors. This proof-of-concept study explores implementation feasibility (retention, technical and safety), and the preliminary effects of Lymfit on various health outcomes. METHOD: This was a single-armed trial with a pre-and post-test design. Twenty lymphoma survivors were recruited to participate in the 12-week Lymfit intervention. Wearable activity trackers (Fitbit) were given to participants as a motivational tool and for data collection purposes. Participants received a personalized exercise prescription designed by a kinesiologist. Physiologic metrics were collected by the Fitbit monitors and were stored in the Lymfit database. Self-reported questionnaires measuring health outcomes were collected at baseline and post-intervention. RESULTS: The retention rate of this trial was 70%. Minimal technical issues and no adverse effects were reported. Lymfit led to significant improvements in sleep disturbances and the ability to participate in social activities and decreased fear of cancer recurrence. It also increased daily steps and decreased sedentary time in participants who did not meet the recommended physical activity guidelines. SIGNIFICANCE: With access to resources and fitness centers being limited during the pandemic, the Lymfit intervention filled an immediate need to provide physical activity guidance to lymphoma survivors. Findings provide preliminary support that implementing the Lymfit intervention is feasible and demonstrated promising results.

Racial and Ethnic Disparities in Operative Experience Among General Surgery Residents: A Multi-Institutional Study from the US ROPE Consortium.

OBJECTIVE: To determine the relationship between race/ethnicity and case volume among graduating surgical residents. BACKGROUND: Racial/ethnic minority individuals face barriers to entry and advancement in surgery; however, no large-scale investigations of the operative experience of racial/ethnic minority residents have been performed. METHODS: A multi-institutional retrospective analysis of the Accreditation Council for Graduate Medical Education case logs of categorical general surgery residents at 20 programs in the US Resident OPerative Experience Consortium database was performed. All residents graduating between 2010 and 2020 were included. The total, surgeon chief, surgeon junior, and teaching assistant case volumes were compared between racial/ethnic groups. RESULTS: The cohort included 1343 residents. There were 211 (15.7%) Asian, 65 (4.8%) Black, 73 (5.4%) Hispanic, 71 (5.3%) "Other" (Native American or Multiple Race), and 923 (68.7%) White residents. On adjusted analysis, Black residents performed 76 fewer total cases (95% CI, -109 to -43, P <0.001) and 69 fewer surgeon junior cases (-98 to -40, P <0.001) than White residents. Comparing adjusted total case volume by graduation year, both Black residents and White residents performed more cases over time; however, there was no difference in the rates of annual increase (10 versus 12 cases per year increase, respectively, P =0.769). Thus, differences in total case volume persisted over the study period. CONCLUSIONS: In this multi-institutional study, Black residents graduated with lower case volume than non-minority residents throughout the previous decade. Reduced operative learning opportunities may negatively impact professional advancement. Systemic interventions are needed to promote equitable operative experience and positive culture change.

Second Fundão Dam Rupture Science Meeting: Updating the science.

The second Fundão Dam Rupture Science Meeting was held in Ouro Preto, Minas Gerais, Brazil, on 21 and 22 September 2022. A total of 100 delegates attended the meeting, which featured high-quality oral presentations and posters over the two days and lively discussions of the science presented. The meeting resulted in nine papers being published in this special series. In the discussion, it was commented that the first meeting had been more a meeting of competitive perspectives but that the second meeting featured a more collaborative sharing of knowledge. Also, there had been substantial improvement in ways to deal with the lack of pre-event data and account for other stressors in the system, and as a result, stronger conclusions regarding the recovery rates of the system were able to be made. Importantly, there was no evidence for a feasible "time bomb" of a future catastrophic release of contaminants, but it was agreed that different scenarios continue to be researched. Integr Environ Assess Manag 2024;20:70-73. © 2023 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

A multi-institutional study from the US ROPE consortium examining factors associated with endocrine surgery exposure for general surgery residents.

BACKGROUND: Prior analyses of general surgery resident case logs have indicated a decline in the number of endocrine procedures performed during residency. This study aimed to identify factors contributing to the endocrine operative experience of general surgery residents and compare those who matched in endocrine surgery fellowship with those who did not. METHODS: We analyzed the case log data of graduates from 18 general surgery residency programs in the US Resident Operative Experience Consortium over an 11-year period. RESULTS: Of the 1,240 residents we included, 17 (1%) matched into endocrine surgery fellowships. Those who matched treated more total endocrine cases, including more thyroid, parathyroid, and adrenal cases, than those who did not (81 vs 37, respectively, P < .01). Program-level factors associated with increased endocrine volume included endocrine-specific rotations (+10, confidence interval 8-12, P < .01), endocrine-trained faculty (+8, confidence interval 7-10, P < .01), and program co-location with otolaryngology residency (+5, confidence interval 2 -8, P < .01) or endocrine surgery fellowship (+4, confidence interval 2-6, P < .01). Factors associated with decreased endocrine volume included bottom 50th percentile in National Institute of Health funding (-10, confidence interval -12 to -8, P < .01) and endocrine-focused otolaryngologists (-3, confidence interval -4 to -1, P < .01). CONCLUSION: Several characteristics are associated with a robust endocrine experience and pursuit of an endocrine surgery fellowship. Modifiable factors include optimizing the recruitment of dedicated endocrine surgeons and the inclusion of endocrine surgery rotations in general surgery residency.

Eric Bywaters and Barbara Ansell: Founders of Modern Pediatric Rheumatology.

Eric Bywaters and Barbara Ansell were, without doubt, two of the giants in the field of Rheumatology. With their keen clinical observations and their visionary development of a dedicated multidisciplinary program focusing on diagnosis, treatment, and research, they are remembered as the founders of the modern specialty of Pediatric Rheumatology.

Imputation strategies for genomic prediction using nanopore sequencing.

BACKGROUND: Genomic prediction describes the use of SNP genotypes to predict complex traits and has been widely applied in humans and agricultural species. Genotyping-by-sequencing, a method which uses low-coverage sequence data paired with genotype imputation, is becoming an increasingly popular SNP genotyping method for genomic prediction. The development of Oxford Nanopore Technologies' (ONT) MinION sequencer has now made genotyping-by-sequencing portable and rapid. Here we evaluate the speed and accuracy of genomic predictions using low-coverage ONT sequence data in a population of cattle using four imputation approaches. We also investigate the effect of SNP reference panel size on imputation performance. RESULTS: SNP array genotypes and ONT sequence data for 62 beef heifers were used to calculate genomic estimated breeding values (GEBVs) from 641 k SNP for four traits. GEBV accuracy was much higher when genome-wide flanking SNP from sequence data were used to help impute the 641 k panel used for genomic predictions. Using the imputation package QUILT, correlations between ONT and low-density SNP array genomic breeding values were greater than 0.91 and up to 0.97 for sequencing coverages as low as 0.1 × using a reference panel of 48 million SNP. Imputation time was significantly reduced by decreasing the number of flanking sequence SNP used in imputation for all methods. When compared to high-density SNP arrays, genotyping accuracy and genomic breeding value correlations at 0.5 × coverage were also found to be higher than those imputed from low-density arrays. CONCLUSIONS: Here we demonstrated accurate genomic prediction is possible with ONT sequence data from sequencing coverages as low as 0.1 × , and imputation time can be as short as 10 min per sample. We also demonstrate that in this population, genotyping-by-sequencing at 0.1 × coverage can be more accurate than imputation from low-density SNP arrays.

What are effective vaccine distribution approaches for equity-deserving and high-risk populations during COVID-19? Exploring best practices and recommendations in Canada: protocol for a mixed-methods multiple case codesign study.

INTRODUCTION: The WHO has stated that vaccine hesitancy is a serious threat to overcoming COVID-19. Vaccine hesitancy among underserved and at-risk communities is an ongoing challenge in Canada. Public confidence in vaccine safety and effectiveness and the principles of equity need to be considered in vaccine distribution. In Canada, governments of each province or territory manage their own healthcare system, providing an opportunity to compare and contrast distribution strategies. The overarching objective of this study is to identify effective vaccine distribution approaches and advance knowledge on how to design and implement various strategies to meet the different needs of underserved communities. METHODS AND ANALYSIS: Multiple case studies in seven Canadian provinces will be conducted using a mixed-methods design. The study will be informed by Experience-Based CoDesign techniques and theoretically guided by the Socio-Ecological Model and the Vaccine Hesitancy Matrix frameworks. Phase 1 will involve a policy document review to systematically explore the vaccine distribution strategy over time in each jurisdiction. This will inform the second phase, which will involve (2a) semistructured, in-depth interviews with policymakers, public health officials, researchers, providers, groups representing patients, researchers and stakeholders and (2b) an analysis of population-based administrative health data of vaccine administration. Integration of qualitative and quantitative data will inform the identification of effective vaccine distribution approaches for various populations. Informed by this evidence, phase 3 of the study will involve conducting focus groups with multiple stakeholders to codesign recommendations for the design and implementation of effective vaccine delivery strategies for equity-deserving and at-risk populations. ETHICS AND DISSEMINATION: This study is approved by the University of Toronto's Health Sciences Research Ethics Board (#42643), University of British Columbia Behavioural Research Ethics Board (#H22-01750-A002), Research Ethics Board of the Nova Scotia Health Authority (#48272), Newfoundland and Labrador Health Research Ethics Board (#2022.126), Conjoint Health Research Ethics Board, University of Calgary (REB22-0207), and University of Manitoba Health Research Board (H2022-239). The outcome of this study will be to produce a series of recommendations for implementing future vaccine distribution approaches from the perspective of various stakeholders, including equity-deserving and at-risk populations.

Evaluating SWAG and Its Validity When Compared to 3D Imagery of Secondarily Grafted Cleft Sites.

OBJECTIVE: To test validity of 2D Standardized Way to Assess Grafts (SWAG) ratings to assess 3D outcomes of bone grafting (ABG). PATIENTS: 43 patients (34 UCLP, 9 BCLP) with non-syndromic complete clefts, bone-grafted at mean age 9yrs/3mos, with available post-graft occlusal radiographs and cone beam computed tomography (CBCT) (taken mean 4yrs/9mos post-ABG). MAIN OUTCOME MEASURES: 2D occlusal radiographs rated twice using SWAG by 6 calibrated raters. 12 scores were averaged and converted to a percentage reflecting bone-fill. Weighted Kappas were assessed for SWAG reliability. 3D cleft-site bone volume was calculated by 1 rater using ITK-SNAP. 13 cleft sites were re-measured by the 'one rater' for 3D reliability using Intraclass Correlation Coefficient (ICC). 2D versus 3D ratings were compared using paired t-test, independent samples t-test, Bland-Altman and Linear Regression. Significance level was P = .5. RESULTS: 2D reliability was 0.724 (intra-rater) and 0.546 (inter-rater). 3D reliability was 0.986. Bland-Altman plot comparing 2D vs 3D showed for 45 of 47 graft-sites were within 2 SD's. Mean % bone-fill was 64.11% with 2D and 69.06% with 3D (mean difference = 4.95%) that was a non-significant difference in both t-tests. Regression showed a statistically significant relation between the two methods (r2 = 0.46; P = .0001). CONCLUSION: 2D SWAG systematically and non-significantly underestimated bone-fill. There was a significant correlation between 2D/3D methods. Bland-Altman analysis illustrated the similarity of the two methods. For comparisons of group (cleft treatment Centers') bone grafting outcomes, the 2D method may suffice as a proxy for the 3D method. However, with individual variation up to 40% in 2D estimates of actual 3D volume, 2D SWAG method cannot be used in place of 3D images.