Clinical and cost-effectiveness of an adapted intervention for preschoolers with moderate to severe intellectual disabilities displaying behaviours that challenge: the EPICC-ID RCT.

Background: Stepping Stones Triple P is an adapted intervention for parents of young children with developmental disabilities who display behaviours that challenge, aiming at teaching positive parenting techniques and promoting a positive parent-child relationship. Objective: To evaluate the clinical and cost-effectiveness of level 4 Stepping Stones Triple P in reducing behaviours that challenge in children with moderate to severe intellectual disabilities. Design, setting, participants: A parallel two-arm pragmatic multisite single-blind randomised controlled trial recruited a total of 261 dyads (parent and child). The children were aged 30-59 months and had moderate to severe intellectual disabilities. Participants were randomised, using a 3 : 2 allocation ratio, into the intervention arm (Stepping Stones Triple P; n = 155) or treatment as usual arm (n = 106). Participants were recruited from four study sites in Blackpool, North and South London and Newcastle. Intervention: Level 4 Stepping Stones Triple P consists of six group sessions and three individual phone or face-to-face contacts over 9 weeks. These were changed to remote sessions after 16 March 2020 due to the coronavirus disease 2019 pandemic. Main outcome measure: The primary outcome measure was the parent-reported Child Behaviour Checklist, which assesses the severity of behaviours that challenge. Results: We found a small non-significant difference in the mean Child Behaviour Checklist scores (-4.23, 95% CI -9.98 to 1.52, p = 0.146) in the intervention arm compared to treatment as usual at 12 months. Per protocol and complier average causal effect sensitivity analyses, which took into consideration the number of sessions attended, showed the Child Behaviour Checklist mean score difference at 12 months was lower in the intervention arm by -10.77 (95% CI -19.12 to -2.42, p = 0.014) and -11.53 (95% CI -26.97 to 3.91, p = 0.143), respectively. The Child Behaviour Checklist mean score difference between participants who were recruited before and after the coronavirus disease 2019 pandemic was estimated as -7.12 (95% CI -13.44 to -0.81) and 7.61 (95% CI -5.43 to 20.64), respectively (p = 0.046), suggesting that any effect pre-pandemic may have reversed during the pandemic. There were no differences in all secondary measures. Stepping Stones Triple P is probably value for money to deliver (-£1057.88; 95% CI -£3218.6 to -£46.67), but decisions to roll this out as an alternative to existing parenting interventions or treatment as usual may be dependent on policymaker willingness to invest in early interventions to reduce behaviours that challenge. Parents reported the intervention boosted their confidence and skills, and the group format enabled them to learn from others and benefit from peer support. There were 20 serious adverse events reported during the study, but none were associated with the intervention. Limitations: There were low attendance rates in the Stepping Stones Triple P arm, as well as the coronavirus disease 2019-related challenges with recruitment and delivery of the intervention. Conclusions: Level 4 Stepping Stones Triple P did not reduce early onset behaviours that challenge in very young children with moderate to severe intellectual disabilities. However, there was an effect on child behaviours for those who received a sufficient dose of the intervention. There is a high probability of Stepping Stones Triple P being at least cost neutral and therefore worth considering as an early therapeutic option given the long-term consequences of behaviours that challenge on people and their social networks. Future work: Further research should investigate the implementation of parenting groups for behaviours that challenge in this population, as well as the optimal mode of delivery to maximise engagement and subsequent outcomes. Study registration: This study is registered as NCT03086876 (https://www.clinicaltrials.gov/ct2/show/NCT03086876?term=Hassiotis±Angela&draw=1&rank=1). Funding: This award was funded by the National Institute for Health and Care Research (NIHR) Health Technology Assessment programme (NIHR award ref: HTA 15/162/02) and is published in full in Health Technology Assessment; Vol. 28, No. 6. See the NIHR Funding and Awards website for further award information.

Research shows that in children without learning disabilities, parenting groups which support parents to develop skills to manage behaviours that challenge in their child can be helpful. The National Institute of Health and Care Excellence recommended that more research was needed to strengthen the evidence for such interventions for children with moderate to severe learning disability who are more likely to display behaviours that challenge in England. In this study, we tested in real-world conditions a programme called level 4 Stepping Stones Triple P, which has shown positive results in trials outside of the United Kingdom. Trained therapists delivered six groups and three individual sessions over 9 weeks to parents of children aged 30­59 months with moderate to severe learning disabilities. Two hundred and sixty-one parents were allocated to one of two arms by chance (randomisation): one received Stepping Stones Triple P and treatment as usual and the other treatment as usual only. Treatment as usual included support and advice by general practitioners or community child development teams. Our primary outcome was parent-reported child behaviour at 12 months after randomisation. We also collected data on other outcomes and carried out interviews with parents, service managers and therapists to find out their views about Stepping Stones Triple P. We did not find that Stepping Stones Triple P reduces behaviours that challenge in the child more than treatment as usual at 12 months. However, when we looked at people who received more than half of the sessions, there was a larger reduction in behaviours which suggests that Stepping Stones Triple P works for families if they attend the full programme. Stepping Stones Triple P seems to be good value for money, as we found that at 12 months (covering 10 months of costs), the Stepping Stones Triple P cost £1058 less than treatment as usual from a health and social care perspective. As such, Stepping Stones Triple P is fairly cheap to deliver and a suitable early intervention for behaviours that challenge especially because of positive feedback from parents. Throughout the trial, we included a Parent Advisory Group that oversaw study materials, interview topic guides and promotion of the study.

Nucleoprotein reassortment enhanced transmissibility of H3 1990.4.a clade influenza A virus in swine.

The increased detection of H3 C-IVA (1990.4.a) clade influenza A viruses (IAVs) in US swine in 2019 was associated with a reassortment event to acquire an H1N1pdm09 lineage nucleoprotein (pdmNP) gene, replacing a TRIG lineage NP (trigNP). We hypothesized that acquiring the pdmNP conferred a selective advantage over prior circulating H3 viruses with a trigNP. To investigate the role of NP reassortment in transmission, we identified two contemporary 1990.4.a representative strains (NC/19 and MN/18) with different evolutionary origins of the NP gene. A reverse genetics system was used to generate wild-type (wt) strains and swap the pdm and TRIG lineage NP genes, generating four viruses: wtNC/19-pdmNP, NC/19-trigNP, wtMN/18-trigNP, and MN/18-pdmNP. The pathogenicity and transmission of the four viruses were compared in pigs. All four viruses infected 10 primary pigs and transmitted to five indirect contact pigs per group. Pigs infected via contact with MN/18-pdmNP shed virus 2 days earlier than pigs infected with wtMN/18-trigNP. The inverse did not occur for wtNC/19-pdmNP and NC/19-trigNP. This suggests that pdmNP reassortment resulted in a combination of genes that improved transmission efficiency when paired with the 1990.4.a hemagglutinin (HA). This is likely a multigenic trait, as replacing the trigNP gene did not diminish the transmission of a wild-type IAV in swine. This study demonstrates how reassortment and evolutionary change of internal genes can result in more transmissible viruses that influence HA clade detection frequency. Thus, rapidly identifying novel reassortants paired with dominant hemagglutinin/neuraminidase may improve the prediction of strains to include in vaccines.IMPORTANCEInfluenza A viruses (IAVs) are composed of eight non-continuous gene segments that can reassort during coinfection of a host, creating new combinations. Some gene combinations may convey a selective advantage and be paired together preferentially. A reassortment event was detected in swine in the United States that involved the exchange of two lineages of nucleoprotein (NP) genes (trigNP to pdmNP) that became a predominant genotype detected in surveillance. Using a transmission study, we demonstrated that exchanging the trigNP for a pdmNP caused the virus to shed from the nose at higher levels and transmit to other pigs more rapidly. Replacing a pdmNP with a trigNP did not hinder transmission, suggesting that transmission efficiency depends on interactions between multiple genes. This demonstrates how reassortment alters IAV transmission and that reassortment events can provide an explanation for why genetically related viruses with different internal gene combinations experience rapid fluxes in detection frequency.

Reporting of determinants of health inequities and participant characteristics in randomized controlled trials of systemic lupus erythematosus in Canada: A scoping review.

OBJECTIVE: To report participant characteristics relevant to identifying health inequities in systemic lupus erythematosus (SLE) randomized controlled trials conducted in Canada. METHODS: We conducted a scoping review by searching MEDLINE (Ovid) and Embase (1990 to June 2023), and CENTRAL (inception to June 2023). Eligible studies: used an RCT design; evaluated interventions (pharmacologic and non-pharmacologic) among SLE patients aged ≥18 years; and were conducted in Canada. Data extraction was guided by the Campbell and Cochrane Equity Methods Group's PROGRESS-Plus framework on 11 factors leading to health inequities (Place of residence; Race, culture, ethnicity, and language; Occupation; Gender and sex; Religion; Education; Socioeconomic status; Social capital; Plus: Personal characteristics associated with discrimination; Features of relationships; and Time-dependent relationships). RESULTS: Of 1901 unique records, 6 met the inclusion criteria. Sex and age were the only PROGRESS factors that were reported in all studies. The majority of participants were female (84.4% to 100%), and mean ages of participants ranged from 42 to 52.3 years. Place of residence, race, education, and social capital were reported in three studies. Socioeconomic status was reported in two studies, and occupation was reported in one study. Religion, features of relationships, and time-dependent relationships were not reported in any included studies. CONCLUSION: Limited reporting of determinants of health inequities in RCTs for SLE in Canada suggests the need for reporting standards to support equity, diversity, and inclusion practices in research.

Prioritizing Maternal Mental Health in Addressing Morbidity and Mortality.

Importance: The rate of maternal mortality in the United States is 2-fold to 3-fold greater than that in other high-income countries. While many national initiatives have been developed to combat maternal mortality, these efforts often fail to include mental illness. Objective: To highlight the underrecognized contribution of mental illness to maternal mortality, which is nearly double that of postpartum hemorrhage. Evidence Review: A topic outline was developed to include challenges in measuring perinatal mental conditions and mortality rates; contributions of social determinants of health to mental conditions and mortality; perinatal psychiatric disorder characterization; mechanisms by which maternal mental illness increases mortality, specifically, suicide and addictive disorders; access limitations and care "deserts"; prenatal stress and its impact on reproductive outcomes; increasing clinician expertise through cross-disciplinary education; intervention sites and models; and asserting that mental health is fundamental to maternal health. Publications in the last 3 years were prioritized, particularly those relating to policy. References were selected through consensus. Sources were PubMed, Ovid, direct data published on government websites, and health policy sources such as the Policy Center for Maternal Mental Health. Findings: Priority was given to recent sources. Citations from 2022-2023 numbered 26; within the last 5 years, 14; and historical references, 15. Recommendations to address each topic area serve as concluding statements for each section. To mitigate the contributions of mental illness to the maternal mortality risk, a coordinated effort is required across professional and governmental organizations. Conclusions and Relevance: Concrete programmatic and policy changes are needed to reduce perinatal stress and address trauma, standardize the collection of social determinant of health data among perinatal patients, increase access to reproductive psychiatry curricula among prescribers, reduce perinatal mental health and obstetrical deserts, institute paid parental leave, and support seamless integration of perinatal and behavioral health care. Moreover, instead of focusing on a relatively minor portion of the contributors to health that current medical practice targets, fortifying the social foundation strengthens the prospects for the health of families for our current and future generations.

Rheumatoid Arthritis Care Experiences of Black People Living in Canada: A Qualitative Study to Inform Health Service Improvements.

OBJECTIVE: To understand experiences related to rheumatoid arthritis (RA) care and propose service-level strategies to reduce and mitigate inequities for Black people living in Canada. METHODS: Purposive and respondent driven sampling was used to recruit participants for qualitative interviews to explore population factors relevant to RA care and challenges and facilitators for access to health care services, medications, and enacting preferred treatment plans. Thematic analysis was conducted using the Braun and Clarke method with inductive and deductive coding and critical race theory guiding analysis. RESULTS: Six women and two men with RA, and two women health care professionals, expressed how their racial identity contributed to their understanding of RA, preferences for treatment, and outcome goals. Health care access was influenced by financial limitations and racism, by exclusion, and discrimination, and also by cultural norms in seeking health care and awareness about RA within the Black community. Participants experienced health system fragmentation and were not connected to ancillary supports. Treatment decision-making was influenced by the legacy of oppression and medical experimentation on Black people and the predominance of biomedical approaches emphasized by health care providers. Holistic and cultural approaches, provided in safe, trauma-informed care environments, with flexibility in service models, are desired. Partnerships between arthritis care services and Black community organizations are proposed to promote community awareness and knowledge about arthritis and provide support mechanisms for patients within their community. CONCLUSION: Our study highlights unique considerations based on race and ethnicity and provides suggestions for arthritis care to mitigate inequities for Black people living with arthritis.

Spontaneous Hemoperitoneum in Pregnancy: Masquerading as Acute Appendicitis.

Spontaneous hemoperitoneum in pregnancy (SHiP) is a rare obstetric emergency that may have an adverse outcome for the mother and baby. This case report describes a unique SHiP case initially diagnosed as acute appendicitis in a patient with severe endometriosis before conception. A woman in her 30s, a primigravida, was admitted with abdominal pain at 32+5 weeks gestational age. Following a surgical review, she was initially diagnosed with acute appendicitis and commenced on intravenous antibiotics. She experienced a dramatic deterioration in her health in the form of clinical shock and fetal distress. She had an emergency laparotomy, a hysterectomy, and a left salpingo-oophorectomy for uncontrollable bleeding. The baby was born in good health, and the mother had an uneventful recovery.

Reporting of determinants of health inequities and participant characteristics in randomized controlled trials of juvenile idiopathic arthritis in Canada: a scoping review.

BACKGROUND: Juvenile Idiopathic Arthritis (JIA) is the most common form of childhood inflammatory arthritis. The disease burden of JIA is substantial as patients require specialized medical practitioners for diagnosis and chronic treatments that are both costly and time intensive. Discrepancies in access to care due to health inequities such as socioeconomic status or geographic location may lead to vastly different health outcomes. As research informs advances in care, is important to consider inclusion and diversity in JIA research. METHODS: We reviewed and synthesized randomized controlled trials for juvenile idiopathic arthritis, the most common type of arthritis among children and adolescents, in Canada with the aim of characterizing participants and identifying how determinants of health inequities are reported. To do so, we searched Medline (1990 to July 2022), Embase (1990 to July 2022), and CENTRAL (inception to July 2022) for articles meeting all of the following criteria: Canadian randomized controlled trials evaluating pharmacological or non-pharmacological interventions on juvenile idiopathic arthritis populations. Data extraction was guided by the Campbell and Cochrane Equity Methods Group's PROGRESS-Plus framework on determinants that lead to health inequities (e.g., Place of residence; Race; Occupation; Gender/Sex; Religion; Education; Socioeconomic status; and Social capital). RESULTS: Of 4,074 unique records, 5 were deemed eligible for inclusion. From these determinants of health inequities, Gender/Sex and Age were the only that were reported in all studies with most participants being female and 12.6 years old on average. In addition, Race, Socioeconomic status, Education and Features of relationships were each reported once in three different studies. Lastly, Place of residence, Occupation, Religion, Social Capital and Time-dependent relationships were not reported at all. CONCLUSIONS: This scoping review suggests limited reporting on determinants of health inequities in randomized controlled trials for JIA in Canada and a need for a reporting framework that reflects typical characteristics of juvenile patient populations.

Exploring the construct of anticipatory stress in finding a job after residency training through cognitive interviewing: Implications for learner well-being and health workforce planning.

Background: Anticipatory stress (AS) is denoted by concern about future events for which there is little control. Most AS research has been physiological studies such as measuring salivary cortisol levels. Medical learners may experience AS regarding employment after residency, however AS a psychological construct across career stages has not previously been studied. The objective of this study is to explore the psychological construct of employment AS in medical students, residents, and former Program Directors (PDs). Methods: Participants were recruited from a large Canadian medical school via purposive sampling. Semi-structured interviews with n=21 participants (six medical students, nine residents, and six PDs) were transcribed verbatim, and coded by two independent reviewers using thematic analysis. Results: Participants agreed that financial, family, and geographical factors exacerbate AS, and it is mitigated by flexibility, social support, and being proactive. External support, job market saturation, and differences between medical specialities also influence AS. Perspectives unique to participant groups included: medical students reflecting on a hidden curriculum and preoccupation with proximal issues over distal concerns of employment; residents experiencing competing residency program demands; former PDs finding that resident competency, yearly hiring fluctuations, and existing stress impact AS. Consequences of AS include physical and psychological manifestations, performance anxiety, and pursuing additional training. Conclusions: Perceptions of AS vary by medical career stage. Individual, program and systems-level changes can help manage and address the underlying cause of AS: an unreliable job market for physicians. Correcting the mismatch between residency positions and job openings may be a proactive, preventative approach.

Pathways from threat exposure to psychotic symptoms in youth: The role of emotion recognition bias and brain structure.

BACKGROUND: Research supports an association between threatening experiences in childhood and psychosis. It is possible that early threat exposure disrupts the development of emotion recognition (specifically, producing a bias for facial expressions relating to threat) and the brain structures subserving it, contributing to psychosis development. METHODS: Using data from the Philadelphia Neurodevelopmental Cohort, we examined associations between threat exposure and both the misattribution of facial expressions to fear/anger in an emotion recognition task, and gray matter volumes in key emotion processing regions. Our sample comprised youth with psychosis spectrum symptoms (N = 304), control youth (N = 787), and to evaluate specificity, youth with internalizing symptoms (N = 92). The moderating effects of group and sex were examined. RESULTS: Both the psychosis spectrum and internalizing groups had higher levels of threat exposure than controls. In the total sample, threat exposure was associated with lower left medial prefrontal cortex (mPFC) volume but not misattributions to fear/anger. The effects of threat exposure did not significantly differ by group or sex. CONCLUSIONS: The findings of this study provide evidence for an effect of threat exposure on mPFC morphology, but do not support an association between threat exposure and a recognition bias for threat-related expressions, that is particularly pronounced in psychosis. Future research should investigate factors linking transdiagnostic alterations related to threat exposure with psychotic symptoms, and attempt to clarify the mechanisms underpinning emotion recognition misattributions in threat-exposed youth.

Neurodevelopmental dimensional assessment of young children at high genomic risk of neuropsychiatric conditions.

Background: Individuals with 22q11.2 deletion are at considerably increased risk of neurodevelopmental and psychiatric conditions. There have been very few studies investigating how this risk manifests in early childhood and what factors may underlie developmental variability. Insights into this can elucidate transdiagnostic markers of risk that may underlie later development of neuropsychiatric outcomes. Methods: Thirty two children with 22q11.2 Deletion Syndrome (22q11.2DS) (mean age = 4.1 [SD = 1.2] years) and 12 sibling controls (mean age = 4.1 [SD = 1.5] years) underwent in-depth dimensional phenotyping across several developmental domains selected as being potential early indicators of neurodevelopmental and psychiatric liability. Comparisons were conducted of the dimensional developmental phenotype of 22q11.2DS and sibling controls. For autistic traits, both parents and children were phenotyped using the Social Responsiveness Scale. Results: Young children with 22q11.2DS exhibited large impairments (Hedge's g ≥ 0.8) across a range of developmental domains relative to sibling controls, as well as high rates of transdiagnostic neurodevelopmental and psychiatric traits. Cluster analysis revealed a subgroup of children with 22q11.2DS (n = 16; 53%) in whom neurodevelopmental and psychiatric liability was particularly increased and who differed from other children with 22q11.2DS and non-carrier siblings. Exploratory analyses revealed that early motor and sleep impairments indexed liability for neurodevelopmental and psychiatric outcomes. Maternal autism trait scores were predictive of autism traits in children with 22q11.2DS (intraclass correlation coefficients = 0.47, p = 0.046, n = 31). Conclusions: Although psychiatric conditions typically emerge later in adolescence and adulthood in 22q11.2DS, our exploratory study was able to identify a range of early risk indicators. Furthermore, findings indicate the presence of a subgroup who appeared to have increased neurodevelopmental and psychiatric liability. Our findings highlight the scope for future studies of early risk mechanisms and early intervention within this high genetic risk patient group.

The neural, stress hormone and inflammatory correlates of childhood deprivation and threat in psychosis: A systematic review.

Childhood adversity increases the risk of developing psychosis, but the biological mechanisms involved are unknown. Disaggregating early adverse experiences into core dimensions of deprivation and threat may help to elucidate these mechanisms. We therefore systematically searched the literature investigating associations between deprivation and threat, and neural, immune and stress hormone systems in individuals on the psychosis spectrum. Our search yielded 74 articles, from which we extracted and synthesized relevant findings. While study designs were heterogeneous and findings inconsistent, some trends emerged. In psychosis, deprivation tended to correlate with lower global cortical volume, and some evidence supported threat-related variation in prefrontal cortex morphology. Greater threat exposure was also associated with higher C-reactive protein, and higher and lower cortisol measures. When examined, associations in controls were less evident. Overall, findings indicate that deprivation and threat may associate with partially distinct biological mechanisms in the psychosis spectrum, and that associations may be stronger than in controls. Dimensional approaches may help disentangle the biological correlates of childhood adversity in psychosis, but more studies are needed.

The effects of vestibular dysfunction on balance and self-concept in children with cochlear implants.

OBJECTIVES: Children with cochlear implants (CCI) have an increased rate of vestibular dysfunction. Vestibular dysfunction is associated with decreased balance and dynamic visual acuity ability. Hearing loss alone is associated with reduced speech perception and vocabulary in children. In adults, vestibular dysfunction is associated with reduced quality of life; however, similar relationships have not been studied in children with vestibular dysfunction. Therefore, the objective of the present study was to evaluate the effect of hearing loss and vestibular dysfunction on self-concept in CCI (n = 33) compared to children with normal hearing (CNH, n = 38). It was hypothesized that children with vestibular dysfunction would have reduced self-concept beyond that from hearing loss, secondary to the presence of balance and visual acuity deficits. METHODS: The Piers-Harris Children's Self-Concept Scale - 2, speech perception, vocabulary, video head impulse test (vHIT), rotary chair, balance using the Bruininks-Oseretsky Test of Motor Proficiency (BOT-2), and dynamic visual acuity (DVA) testing were completed on all participants. RESULTS: In the 34 CCI, 24 had normal vestibular function, 6 had unilateral vestibular dysfunction, and 4 had bilateral vestibular dysfunction. There were no significant mean differences in the Piers-Harris Children's Self-Concept Scale - 2 between groups. A Principal Component Analysis (PCA) was conducted on the predictor variables (average horizontal canal vHIT gain, BOT-2 score, DVA, speech perception, and vocabulary) resulting in two factors; factor 1 represented "vestibular" components (vHIT, BOT-2, and DVA) and factor 2 represented "auditory-language" components (speech perception and vocabulary). In addition to age and gender, the 2 PCA factors were analyzed using multivariate regression with stepwise selection to determine which factors best predicted self-concept. The PCA auditory-language factor was the only significant predictor of self-concept. CONCLUSIONS: Auditory-language, not vestibular related factors, contribute to the self-concept of CCI. While adults with vestibular dysfunction have reduced quality of life, it could be that children with vestibular dysfunction have some psychosocial resilience.

Functional Headings’ Effects on Selective Attention and Reading Processes / [La influencia de los encabezados funcionales en los procesos de atención selectiva y lectura]

Textual devices such as headings convey both content information and functional information. One type of headings is referred to as functional headings, since they provide functional information but not content information. Headings such as “Introduction” denote the function of a text section but not the content information of that section. The current study included three experiments that investigated the processing of functional information during reading. Experiment 1 investigated the effects of functional information in a timed reading situation. Experiments 2 and 3 looked at the effects of functional information when there was a contradiction in the text. Our results indicated that functional information promoted selective attention during timed reading (Experiment 1). Findings from our contradiction manipulation (Experiments 2 and 3) revealed that readers used functional headings to guide their structural reading process. Implications for cognitive processes during reading and pedagogical practices are described in the general discussion section.(AU)

Las ayudas de texto, como los encabezados, transmiten tanto información de contenido como información funcional. Uno de los tipos de encabezados se conoce como encabezados funcionales, pues proporcionan información funcional pero no información de contenido. Los encabezados como “Introducción” denotan la función de una sección de texto, pero no la información de contenido de esa sección. El estudio actual incluyó tres experimentos que investigaron el procesamiento de información funcional durante la lectura. El experimento 1 investigó los efectos de la información funcional en una situación de lectura cronometrada. Los experimentos 2 y 3 analizaron los efectos de la información funcional cuando había una contradicción en el texto. Nuestros resultados indicaron que la información funcional propició la atención selectiva durante la lectura cronometrada (experimento 1). Los resultados de nuestra manipulación de contradicciones (experimentos 2 y 3) revelaron que los lectores usaban encabezados funcionales para guiar su proceso de lectura estructural. Las implicaciones para los procesos cognitivos durante la lectura y las prácticas pedagógicas se describen en la sección de discusión general.(AU)

Preferences for COVID-19 Vaccination in People With Chronic Immune-Mediated Inflammatory Diseases.

OBJECTIVE: To understand how people with chronic immune-mediated inflammatory diseases (IMIDs) trade off the benefits and risks of coronavirus disease 2019 (COVID-19) vaccine options. METHODS: We conducted an online discrete-choice experiment in people with IMIDs to quantify the relative importance (RI) of attributes relevant to COVID-19 vaccination. Participants were recruited between May and August 2021 through patient groups and clinics in Canada, and completed 10 choices where they selected 1 of 2 hypothetical vaccine options or no vaccine. The RI of each attribute was estimated and heterogeneity was explored through latent class analysis. RESULTS: The survey was completed by 551 people (89% female, mean age 46 yrs) with a range of IMIDs (inflammatory bowel disease [48%], rheumatoid arthritis [38%], systemic lupus erythematosus [16%]). Most had received 1 (94%) or 2 (64%) COVID-19 vaccinations. Across the ranges of levels considered, vaccine effectiveness was most important (RI = 66%), followed by disease flare (21%), rare but serious risks (9%), and number/timing of injections (4%). Patients would accept a risk of disease flare requiring a treatment change of ≤ 8.8% for a vaccine with a small absolute increase in effectiveness (10%). Of the 3 latent classes, the group with the greatest aversion to disease flare were more likely to be male and have lower incomes, but this group still valued effectiveness higher than other attributes. CONCLUSION: Patients perceived the benefits of COVID-19 vaccination to outweigh rare serious risks and disease flare. This supports COVID-19 vaccine strategies that maximize effectiveness, while recognizing the heterogeneity in preferences that exists.

Reporting of Determinants of Health Inequities in Rheumatoid Arthritis Randomized Controlled Trials in Canada: A Scoping Review.

OBJECTIVE: More than ever, it is important to consider inclusion and diversity in rheumatology research. We reviewed and synthesized randomized controlled trials (RCTs) for rheumatoid arthritis (RA) in Canada with the aim of characterizing participants and identifying how determinants of health inequities are reported. METHODS: We conducted a scoping review following the Arksey and O'Malley framework. We searched Medline (1990 to December 2021), Embase (1990 to December 2021), and CENTRAL (inception to December 2021) for articles meeting inclusion criteria of: 1) used an RCT design; 2) evaluated pharmacologic or nonpharmacologic interventions; 3) included participants with RA; and 4) conducted in Canada. Data extraction was guided by the Campbell and Cochrane Equity Methods Group's PROGRESS-Plus framework on determinants that lead to health inequities (e.g., place of residence; race; occupation; gender/sex; religion; education; socioeconomic status; and social capital). RESULTS: Of 6,290 unique records, 42 were eligible for inclusion. We grouped studies according to 3 time periods: before 2000; 2000-2010; and 2011 to present. Participants of included studies were mostly middle-aged, female, and White. Sex and age were the most widely reported determinants in 41 studies. Other determinants reported were race (15 studies), education (11 studies), socioeconomic status (7 studies), and occupation (6 studies). Religion, features of relationships, and time-dependent relationships were not reported in any study. CONCLUSION: This scoping review suggests limited reporting on determinants of health inequities in RCTs for RA in Canada. Establishing reporting standards for equity factors in RCTs is important for addressing health inequities and informing accessible research and care for patients with RA.

Exploring perceptions of using preference elicitation methods to inform clinical trial design in rheumatology: A qualitative study and OMERACT collaboration.

BACKGROUND: Clinical trial design requires value judgements and understanding patient preferences may help inform these judgements, for example when prioritizing treatment candidates, designing complex interventions, selecting appropriate outcomes, determining clinically important thresholds, or weighting composite outcomes. Preference elicitation methods are quantitative approaches that can estimate patients' preferences to quantify the absolute or relative importance of outcomes or other attributes relevant to the decision context. We aimed to explore stakeholder perceptions of using preference elicitation methods to inform judgements when designing clinical trials in rheumatology. METHODS: We conducted 1-on-1 semi-structured interviews with patients with rheumatic diseases and rheumatology clinicians/researchers, recruited using purposive and snowball sampling. Participants were provided pre-interview materials, including a video and a document, to introduce the topic of preference elicitation methods and case examples of potential applications to clinical trials. Interviews were conducted via Zoom and were audio-recorded and transcribed. We used thematic analysis to analyze our data. RESULTS: We interviewed 17 patients and 9 clinicians/researchers, until data and inductive thematic saturation were achieved within each group. Themes were grouped into overall perceptions, barriers, and facilitators. Patients and clinicians/researchers generally agreed that preference elicitation studies can improve clinical trial design, but that many considerations are required around preference heterogeneity and feasibility. A key barrier identified was the additional resources and expertise required to measure and incorporate preferences effectively in trial design. Key facilitators included developing guidance on how to use preference elicitation to inform trial design, as well as the role of external decision-makers in developing such guidance, and the need to leverage the movement towards patient engagement in research to encourage including patient preferences when designing trials. CONCLUSION: Our findings allowed us to consider the potential applications of patient preferences in trial design according to stakeholders within rheumatology who are involved in the trial process. Future research should be conducted to develop comprehensive guidance on how to meaningfully include patient preferences when designing clinical trials in rheumatology. Doing so may have important downstream effects for shared decision-making, especially given the chronic nature of rheumatic diseases.

Social prescribing of nature therapy for adults with mental illness living in the community: A scoping review of peer-reviewed international evidence.

Social prescribing of nature therapy "green social prescribing" facilitates access to local nature-based activities that improve biopsychosocial wellbeing outcomes, are affordable, accessible, and can be adapted to context. These are becoming increasingly popular and gray literature is emerging, however, peer-reviewed scientific evidence is exiguous. This scoping review aimed to identify and critique peer-reviewed evidence for green social prescribing interventions and develop recommendations for research and clinical practice. Included studies were published in peer-reviewed journals in English on/after 1 January 2000. Participants were community-living adults with mental illness; Intervention was any green social prescribing program; Comparator was not restricted/required; Outcomes were any biopsychosocial measures; and any/all Study Designs were included. Twelve databases were searched on 15 October 2022; these were Academic Search Premier, APA PsycArticles, APA PsycINFO, CINAHL, Cochrane Library, Google Scholar, JSTOR, ProQuest, PubMed, Science Direct, Scopus, and Web of Science. The Mixed Methods Appraisal Tool was used to assess quality. Seven publications describing 6 unique studies (5 UK, 1 Australia) were identified including 3 mixed-methods, 2 qualitative, and 1 RCT. Participants included 334 adults (45% female, aged 35-70 years); sample sizes ranged from 9 to 164. All studies showed improvements in biopsychosocial wellbeing, and participants from most studies (n = 5) reported increased connection to the earth and intention to further access nature. Participant demographics and diagnoses were poorly reported, and intervention activities and assessments varied considerably. However, MMAT scores were good overall suggesting these studies may reliably demonstrate intervention outcomes. We conclude that socially prescribed nature therapy can improve biopsychosocial wellbeing and is a potentially important intervention for mental illness. Recommendations for research and clinical practice are provided.

An Audit on Oncological Safety with Magseed Localised Breast Conserving Surgery.

Wire-localised wide local excision (W-WLE) has been standard of care for impalpable breast lesions. Logistics and risks of wire localisation can be challenging. Magseed-localised wide local excision (M-WLE) is an alternative to W-WLE. We compare safety parameters and length of hospital stay (LOS) in patients undergoing M-WLE to W-WLE. All M-WLEs performed at single institution over an 8-month period were included and compared to historic matched cohort of W-WLEs who would have been suitable for Magseed localisation. Data including patient demographics, successful placements, re-excision rates, tumour size, and length of stay (LOS) was analysed. Two hundred thirty-eight patients were included in the study. Cancers were safely excised in all cases. A significant difference in re-excisions rates favouring M-WLE group was seen (2.9% vs 10.4%). Median waiting time to surgery was significantly shorter in M-WLE group (4 h 15 min vs 7 h 3 min). No significant difference in median LOS between the two groups was seen. M-WLE has been shown to be oncologically safe and non-inferior to W-WLE with significantly lower re-excision rate. Reduced pre-operative waiting time in the M-WLE group will have a positive effect on patient journey. Further research should focus on potential impact on day-bed utilisation and theatre efficiency.

Methods to Summarize Discrete-Choice Experiments in a Systematic Review: A Scoping Review.

BACKGROUND AND OBJECTIVE: Systematic reviews of discrete-choice experiments (DCEs) are being increasingly conducted. The objective of this scoping review was to identify and describe the methodologies that have been used to summarize results across DCEs. METHODS: We searched the electronic databases MEDLINE and EMBASE from inception to March 18, 2021, to identify English-language systematic reviews of patient preferences that included at least two DCEs and extracted data on attribute importance. The methods used to summarize results across DCEs were classified into narrative, semi-quantitative, and quantitative (meta-analytic) approaches and compared. Approaches to characterize the extent of preference heterogeneity were also described. RESULTS: From 7362 unique records, we identified 54 eligible reviews from 2010 to Mar 2021, across a broad range of health conditions. Most (83%) used a narrative approach to summarize findings of DCEs, often citing differences in studies as the reason for not formally pooling findings. Semi-quantitative approaches included summarizing the frequency of the most important attributes, the frequency of attribute statistical significance, or tabulated comparisons of attribute importance for each pair of attributes. One review conducted a meta-analysis using the maximum acceptable risk. While reviews often commented on the heterogeneity of patient preferences, few (6%) addressed this systematically across studies. CONCLUSION: While not commonly used, several semi-quantitative and one quantitative approach for synthesizing results of DCEs were identified, which may be useful for generating summary estimates across DCEs when appropriate. Further work is needed to assess the validity and usefulness of these approaches.