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The original Promoting Action on Research Implementation in Health Services (PARiHS) and i-PARiHS frameworks contend that the successful implementation of evidence-based practices is a function of the core elements evidence, context, facilitation, and the capacity of intended recipients to apply research to practice. While applied widely, a number of theoretical and practical challenges associated with the framework’s application have been identified. Our critical interpretive synthesis examines how the last decade of research has advanced understanding of the conceptualizations of, relationships between, and dynamics amongst, PARiHS core elements. We find that work over the past decade affords more nuanced conceptualizations of context and facilitation; reveals myriad conceptualizations of implementation success, suggesting the need for a typology; demonstrates contradictory effects of context on facilitation that warrants more study; leads us to question the contextual primacy of leadership; and generally under-examines the interactions and dynamics amongst PARiHS core elements and their sub-elements.

ObjectivesOur primary objective was to estimate the association between loneliness and unmet healthcare needs and if the association changes when adjusted for demographic and health factors. Our secondary objective was to examine the associations by gender (men, women, gender diverse).Design, setting, participantsRetrospective cross-sectional data from 44 423 community-dwelling Canadian Longitudinal Study on Aging participants aged 45 years and older were used.Primary outcome measureUnmet healthcare needs are measured by asking respondents to indicate (yes, no) if there was a time when they needed healthcare in the last 12 months but did not receive it.ResultsIn our sample of 44 423 respondents, 8.5% (n=3755) reported having an unmet healthcare need in the previous 12 months. Lonely respondents had a higher percentage of unmet healthcare needs (14.4%, n=1474) compared with those who were not lonely (6.7%, n=2281). Gender diverse had the highest percentage reporting being lonely and having an unmet healthcare need (27.3%, n=3), followed by women (15.4%, n=887) and men (13.1%, n=583). In our logistic regression, lonely respondents had higher odds of having an unmet healthcare need in the previous 12 months than did not lonely (adjusted odd ratios (aOR) 1.80, 95% CI 1.64 to 1.97), adjusted for other covariates. In the gender-stratified analysis, loneliness was associated with a slightly greater likelihood of unmet healthcare needs in men (aOR 1.90, 95% CI 1.64 to 2.19) than in women (aOR 1.73, 95% CI 1.53 to 1.95). In the gender diverse, loneliness was also associated with increased likelihood of having an unmet healthcare need (aOR 1.38, 95% CI 0.23 to 8.29).ConclusionsLoneliness was related to unmet healthcare needs in the previous 12 months, which may suggest that those without robust social connections experience challenges accessing health services. Gender-related differences in loneliness and unmet needs must be further examined in larger samples.

While assisted living (AL) communities emphasize resident safety, one barrier to resident safety is a lack of information about AL stakeholders’ safety priorities. As part of a larger research project to create a toolkit to foster resident and family engagement in safety in AL, we created a stakeholder panel that includes 13 AL residents, family members, and professionals (i.e., direct care workers, administrators, researchers, and policymakers). This paper describes a web-based Delphi process to create a ranked safety priority list with stakeholders. After three rounds involving online surveys and Zoom group discussions, the stakeholder group came to a consensus on a final list of 14 ranked safety priorities. Using verbatim transcripts of the Zoom discussions and chat, we conducted content analysis to highlight the rationales for the 14 ranked safety priorities on the final list. Reasons to prioritize safety concerns included the seriousness of the impact on AL residents and system-level root causes. These findings will be used to guide the development of a toolkit to improve resident and family engagement in the safety of AL. This list can also help AL communities and researchers at large to better understand what safety priorities are most important to a broad range of AL stakeholders and why.

88 Background: Historically, US clinical trials have been shown to recruit disproportionately large percentages of White patients, raising concerns about the generalizability of clinical trial results to underrepresented racial minority patient populations. Because of this, the FDA has recently reiterated its guidance stating that clinical trials need to reflect the demographic distribution of the US. In this research, we sought to understand how participation of Black patients varies by therapeutic area and geography within the US. Methods: Studying patient-level clinical trial data from an industry-leading historical clinical trial data repository of over 8 million patients from 27,000 clinical trials, we assessed the racial composition of US interventional trials across indications from 2010 to 2021 which encompassed 433,822 clinical trial participants across 2,997 trials. We also analyzed participants’ racial composition within the subset of trials from three distinct therapeutic areas (i.e., oncology n = 118,194, cardiovascular n = 12,281, central nervous system n = 35,533) and distinct sites over the same period. Results: The racial distribution of clinical trial participants in the US across all therapeutic areas was 78% White, 15% Black, and 3% Asian. Within the three distinct therapeutic areas, the proportion of Black clinical trial participants varied, with oncology trials reporting 8.5% Black participants, cardiovascular trials reporting 15.3% Black participants, and central nervous system trials reporting 19.9% Black participants. Black participation also varied within a therapeutic area, depending on the indication, as well as by site, with individual sites contributing differently to the racial diversity of trials. Conclusions: Our analysis shows that US interventional trials enroll 15% Black participants, appearing consistent with the 2020 US Census, which estimates that 14.6% of Americans are Black. However, more granular analyses at the level of therapeutic area, indication and site suggest substantial variation in Black participation in clinical trials including a gap in Black representation in oncology trials vs. US Census estimates. This research suggests that aggregate estimates of racial enrollment may mask dramatic variation by other factors like granularity of disease area and geographic location. The study of historic clinical trial data may yield useful insights for accelerating diverse representation in clinical trials.

Importance The BNT162b2 (Pfizer-BioNTech) messenger RNA COVID-19 vaccine was authorized on May 10, 2021, for emergency use in children aged 12 years and older. Initial reports showed that the vaccine was well tolerated without serious adverse events; however, cases of myocarditis have been reported since approval. Objective To review results of comprehensive cardiac imaging in children with myocarditis after COVID-19 vaccine. Design, setting, and participants This study was a case series of children younger than 19 years hospitalized with myocarditis within 30 days of BNT162b2 messenger RNA COVID-19 vaccine. The setting was a single-center pediatric referral facility, and admissions occurred between May 1 and July 15, 2021. Main outcomes and measures All patients underwent cardiac evaluation including an electrocardiogram, echocardiogram, and cardiac magnetic resonance imaging. Results Fifteen patients (14 male patients [93%]; median age, 15 years [range, 12-18 years]) were hospitalized for management of myocarditis after receiving the BNT162b2 (Pfizer) vaccine. Symptoms started 1 to 6 days after receipt of the vaccine and included chest pain in 15 patients (100%), fever in 10 patients (67%), myalgia in 8 patients (53%), and headache in 6 patients (40%). Troponin levels were elevated in all patients at admission (median, 0.25 ng/mL [range, 0.08-3.15 ng/mL]) and peaked 0.1 to 2.3 days after admission. By echocardiographic examination, decreased left ventricular (LV) ejection fraction (EF) was present in 3 patients (20%), and abnormal global longitudinal or circumferential strain was present in 5 patients (33%). No patient had a pericardial effusion. Cardiac magnetic resonance imaging findings were consistent with myocarditis in 13 patients (87%) including late gadolinium enhancement in 12 patients (80%), regional hyperintensity on T2-weighted imaging in 2 patients (13%), elevated extracellular volume fraction in 3 patients (20%), and elevated LV global native T1 in 2 patients (20%). No patient required intensive care unit admission, and median hospital length of stay was 2 days (range 1-5). At follow-up 1 to 13 days after hospital discharge, 11 patients (73%) had resolution of symptoms. One patient (7%) had persistent borderline low LV systolic function on echocardiogram (EF 54%). Troponin levels remained mildly elevated in 3 patients (20%). One patient (7%) had nonsustained ventricular tachycardia on ambulatory monitor. Conclusions and relevance In this small case series study, myocarditis was diagnosed in children after COVID-19 vaccination, most commonly in boys after the second dose. In this case series, in short-term follow-up, patients were mildly affected. The long-term risks associated with postvaccination myocarditis remain unknown. Larger studies with longer follow-up are needed to inform recommendations for COVID-19 vaccination in this population.

Background: Immigrants constitute 30% of Canada’s older adult population. Immigrant older adults have low levels of physical activity coupled with higher risks for cardiovascular disease and obesity in some sub-populations. Community group-based physical activity programs combine both physical and social benefits and are well received by older adults. These programs often lack sensitivity to the needs of equity-deserving groups, such as immigrants, who continue to experience lower levels of participation. Local, accessible, and culturally informed approaches are required to remedy these well documented inequities in who has access to and benefits from such programs. There is a gap, however, in our understanding of the characteristics and conditions for effective program design and delivery when the target population is immigrant older adults.Methods: The aim of this equity-focused realist review is to develop a programme theory that explains how, why, for whom, and under which circumstances community group-based physical activity programs work when delivered to older immigrants. We will first articulate an initial programme theory that explains tentatively how, why and for whom such programs work and then test and refine the programme theory using a systematic realist review process. The initial programme theory will draw from existing theories that inform group-based physical activity programs for older adults, intersectional theory, and stakeholder insights. PROGRESS-Plus factors will be explored in relation to relevance and impact for physical activity interventions. Stakeholders will include service providers, community volunteers and leaders who have extensive knowledge and interactions with immigrant communities. The initial programme theory will then be tested and refined using a systematic process of searching, retrieving, and reviewing literature on physical activity in immigrant populations. The final programme theory will be validated using stakeholder input and the research team’s expertise in aging, health equity, and physical activity. Discussion: Physical activity improves the wellbeing of older adults, decreases frailty, and supports aging in place. Ensuring that all older adults can participate in such programs entails understanding what works for whom, when and under which circumstances. This review will provide recommendations on best practices to support immigrant older adults’ participation in group-based physical activity programs.Systematic review registration: The protocol has been submitted to PROSPERO for registration (ID#258179, Date submitted May 30th, 2021.

This presentation provides and overview of a mixed-methods stakeholder engaged study to develop a toolkit to encourage resident and family engagement in the safety of assisted living (AL). This study uses stakeholder-based data and stakeholder engaged processes to adapt existing tools and strategies from other settings to encourage resident and family engagement in the safety of AL. We will improve resident safety in AL by developing an evidence-based tool to implement these engagement tools/strategies in AL. The presentation will outline the theoretical base, the approach for this study, including efforts to recruit and retain stakeholders throughout the study, and stakeholder engaged process to develop the toolkit. The presentation will include challenges and strategies to encourage participation of AL staff, residents, and family caregivers in the study. The presentation will conclude with a discussion of implications for future design and research efforts aiming to impact AL care, policy, and research implementation.

Maximizing long-term care (LTC) residents' quality of life (QoL) is the primary goal of care. However, most residents have cognitive impairment and care staff time is severely limited, leading to various complexities in measuring QoL. This study developed and assessed the feasibility of an approach to routinely measuring QoL in LTC residents. We used the DEMQOL-CH, a practical, reliable, valid tool, developed in the UK to be completed by care aides to assess QoL in residents with moderate to severe dementia. We recruited 45 care aides in 10 LTC homes in Alberta, Canada who we surveyed on the QoL of 263 residents via video calls. We assessed time to complete; care aide and manager perceived feasibility of completing the DEMQOL-CH; internal consistency and inter-rater reliability of DEMQOL-CH scores; and we conducted cognitive interviews with 7 care aides to assess care aide comprehension of the tool. Time to complete was on average 4 minutes with little variation. Care aides and managers rated using the DEMQOL-CH as highly feasible and valuable. The internal consistency of the DEMQOL-CH score was 0.80. The DEMQOL-CH score inter-rater agreement was 0.73. Cognitive interviews suggested good comprehension overall with some comprehension problems especially in care aides who speak English as a second language. Asking care aides to complete the DEMQOL-CH is highly feasible, requires minor resources, and reliability is high. However, some items caused comprehension and reliability problems. Reasons and possible solutions will be subject to further investigations.

Sooner murder an infant in its cradle than nurse unacted desires (William Blake)1Lady Macbeth's reference to motherhood and infanticide near the end of act one of Macbeth remains one of the more enigmatic moments in all of Shakespeare's drama. Fearing Macbeth's wavering commitment to their succession scheme, Lady Macbeth declares that she would have "dashed the brains out" (1.7.58)2 of an infant to realize an otherwise unachievable goal. Scholars have traditionally read this as well as her earlier "unsex me here" (1.5.39) invocation as evidence of Lady Macbeth's attempt to seize a masculine power to further Macbeth's political goals. To overcome her husband's feminized reticence, Lady Macbeth assumes a masculinity she will prove unable to support. While she clearly seeks power, such power is, I would argue, conditioned on maternity, an ambiguous, conflicted status in early modern England. Indeed, the images of nursing and infanticide that frame Lady Macbeth s act one fantasy invoke a maternal agency, momentarily empowering the achievement of an illegitimate political goal.That mothers could undermine patrilineal outcomes, in fact, contributed to a generalized cultural anxiety about women's roles in the transmission of patrilineage. That patrilineage could be irreparably altered through marital infidelity, nursing, and infanticide rendered maternal agency a social and political concern. Lady Macbeth's act one fantasy reveals much, in fact, about the early modern anxiety surrounding mothers' roles in the perpetuation of patrilineage. In the case of this woman who would be queen, Lady Macbeth s engineered murder of Duncan engenders the unlawful succession of a bastardized Macbeth, altering, in turn, the patrilineal as well as political order within the world of the play.That motherhood was viewed as problematic in early modern England may be evinced in conduct literature of the period addressing the subject of good mothering.3 As Frances Dolan notes, "the fear of, fascination with, and hostility toward maternal power in early modern English culture motivated attempts to understand and control, even repudiate it [...]" (2000, 283). While on the one hand mothers were praised for a selfless devotion to their children, they were likewise condemned for harming the innocents entrusted to their care. As Dympna Callaghan notes, "women were persecuted as mothers: as bad old mothers for witchcraft, and as bad young mothers for infanticide" (1992, 367). Naomi Miller observes that "mothers and other female caregivers appear as both objects and agents of sacrifice in early modern texts and images, sometimes represented as madonna and monster at once" (2000, 7). Susan Frye concludes that the maternal role has historically been an "unstable" one, that the struggle to "imagine a 'self'" rendered motherhood a confused, anxiety-producing state in early modern England (2000, 229). Christopher Newstead's An apology for women: or women's defence (1620) illustrates well the conflicting attitudes toward motherhood. On the one hand, he argues that "there is no ingratitude comparable to that which is committed against the mother" (Aughterson 1995,116). For as he notes, "we have of them principally our essence; secondly our nourishment; thirdly our education" (116).Yet Newstead likewise registers a highly discernable anxiety about the dangers of maternal agency. For while, as he notes, "educing, education and affection are the threefold cords that should tie each child to the love of its mother" (116), a mother's love was conditioned on the undeniable assurance of her child's matrilineal identity. Indeed, as Newstead further observes, "two reasons may be given why they [mothers] do most affect their children. First because they are certain they are theirs. Wherefore Telemachus being asked, if it were true that Ulysses was his father? Answered, my mother saith he was" (116).4WhHe Newstead's treatise openly praises the virtues of mothers as well as the social and familial debt owed them, it likewise points to early modern concerns about maternal agency. …

This is a significant contribution to the history of ceremonial semiotics in early modern Europe, a truly interdisciplinary work, with essays by historians, art historians, and literary scholars.