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Medical and surgical advancements have enabled a 95% survival rate for children with CHD. However, these survivors are disproportionately affected by neurodevelopmental disabilities. In particular, they have behavioural problems in toddlerhood. Because there is a known relationship between behavioural problems and early language delay, we hypothesise that children with critical CHD have early detectable language deficits. To test our hypothesis, we performed a retrospective study on a cohort of children with critical CHD to visualise their early language developmental trajectories.
Methods:
We identified a cohort of 27 children with two diagnoses: single ventricle physiology (19) and transposition of the great arteries (8). As part of their routine clinical care, all of these children had serial developmental evaluations with the language subsection of the Capute Scales. We visualised their developmental language trajectories as a function of chronologic age, and we used a univariate linear regression model to calculate diagnosis-specific expected developmental age equivalents.
Results:
In each group, language development is age-appropriate in infancy. Deviation from age-appropriate development is apparent by 18 months. This results in borderline-mild language delay by 30 months.
Discussion:
Using the Capute Scales, our team quantified early language development in infants and toddlers with critical CHD. Our identification of deceleration in skill acquisition reinforces the call for ongoing neurodevelopmental surveillance in these children. Understanding early language development will help clinicians provide informed anticipatory guidance to families of children with critical CHD.
Social Media Synopsis:
Children with single ventricle physiology and transposition of the great arteries have measurable early language delays.
The analysis of coprolites provides direct evidence of resources consumed and may be paired with ethnographic data to elucidate the dietary and medicinal use of plants in archaeological communities. This article combines and contrasts the macroscopic analysis and DNA metabarcoding of 10 coprolites from Bonneville Estates Rockshelter, Nevada, USA. While the results from both methods confirm previous understandings of subsistence practices at the site, minimal overlap in identified taxa suggests that each accesses different components of the consumed material. The two methods should therefore be seen as complementary and employed together, where possible.
Background: Asymptomatic bacteriuria (ASB) is often treated with antibiotics despite recommendations against screening for and treating ASB in most populations. Some providers cite concern for progression of ASB to a symptomatic urinary tract infection (UTI) as the jultification for antibiotic use. While the 2019 Infectious Diseases Society of America (IDSA) ASB guidelines refute this concern, most evidence is derived from studies done in females, potentially limiting external validity. The purpose of this study is to compare the outcomes of patients with ASB who received antibiotic treatment versus those who did not in a primarily male population. Methods: This is a multi-center, retrospective, cohort study conducted by the 5 sites within the Veterans Affairs MidSouth Healthcare Network. Patients with a positive urine culture (defined as cultures with a colony forming unit count >100,000) collected from January 1, 2021 through December 31, 2021 were identified. ASB was determined via chart review using pre-determined criteria (positive culture in the absence of reported or documented signs or symptoms attributable to UTI as defined by the 2019 IDSA ASB guidelines). Additional data collected included antibiotic use, clinic visits and hospital admissions related to UTI or sepsis from a UTI. The primary outcome was the comparison of UTI incidence at 30 days, 6 months, and 1 year in those untreated versus treated with antibiotics. Secondary outcomes included a comparison of admissions with sepsis from UTI and adverse drug reactions (ADRs) between the cohorts. Continuous data were analyzed using a Student’s t-test. Discrete data were analyzed using either a Chi-squared or Fisher’s exact test. Results: The study population was primarily elderly (73 years, range 27-99 years) and male (79.7%). Of the 281 patients with ASB, 127 (45.2%) and 154 (54.8%) were untreated and treated, respectively. The incidence of UTI was 3% versus 1% (p = 0.41) at 30 days, 10% versus 12% (p = 0.61) at 6 months and 11% versus 12% (p = 0.94) at 12 months in the untreated and treated cohorts, respectively. There was no difference in admissions for UTI, sepsis from UTI or ADRs at 30 days. Conclusion: This study found no difference in the development of symptomatic UTI in veterans with untreated ASB compared to those treated with antibiotics. These findings align with current ASB guideline recommendations and support avoidance of unnecessary antibiotic use in the veteran population.
Autistic people have a high likelihood of developing mental health difficulties but a low chance of receiving effective mental healthcare. Therefore, there is a need to identify and examine strategies to improve mental healthcare for autistic people.
Aims
To identify strategies that have been implemented to improve access, experiences of care and mental health outcomes for autistic adults, and to examine evidence on their acceptability, feasibility and effectiveness.
Method
A co-produced systematic review was conducted. MEDLINE, PsycINFO, CINHAL, medRxiv and PsyArXiv were searched. We included all study designs reporting acceptability or feasibility outcomes and empirical quantitative study designs reporting effectiveness outcomes. Data were synthesised using a narrative approach.
Results
A total of 30 articles were identified. These included 16 studies of adapted mental health interventions, eight studies of service improvements and six studies of bespoke mental health interventions developed for autistic people. There was no conclusive evidence on effectiveness. However, most bespoke and adapted approaches appeared to be feasible and acceptable. Identified adaptations appeared to be acceptable and feasible, including increasing knowledge and detection of autism, providing environmental adjustments and communication accommodations, accommodating individual differences and modifying the structure and content of interventions.
Conclusion
Many identified strategies are feasible and acceptable, and can be readily implemented in services with the potential to make mental healthcare more suitable for autistic people, but important research gaps remain. Future research should address these and investigate a co-produced package of service improvement measures.
Queer displacement is a central theme within the popular song ‘Smalltown Boy’, Bronski Beat's first single from their debut album. A young gay man stands alone on a platform waiting for a train to transport him to a more hopeful place; ‘the wind and the rain on a sad and lonely face’. The feelings of pain, loss and hopelessness that permeate the song generate a powerful image of a generic small town inhospitable to queer life. The second verse and chorus (‘run away, turn away’) illustrate the concept of mobility within popular and academic understandings of the (im)possibility of queer life in regional and rural areas, ‘the answers you seek will never be found at home, the love that you need will never be found at home’. To actualize a queer identity and find love, lesbian, gay, bisexual, trans, intersex, queer and asexual (LGBTIQA+ ) people are thought to move from the regions to safer and more accepting urban environments (Gorman- Murray, 2007; Cover et al, 2020). Reinforcing this narrative of displacement are cautionary tales of discrimination or violence against LGBTIQA+ who (mistakenly) try to settle or remain in the regions. From this metropolitan viewpoint, rural and regional areas are constructed as strange, distant and filled with populations hostile to LGBTIQA+ communities and dangerous individuals (Halberstam, 2005).
These distinct but complementary narratives – rural- to- urban journeys of queer self- discovery (Gorman- Murray, 2007) and the discrimination and violence that LGBTIQA+ are potentially subject to in regional areas – have contributed to what Halberstam (2005) terms a metronormative narrative. LGBTIQA+ people living outside of urban centres are constructed as ‘sad’ or ‘lonely’ or, alternatively, ‘stuck in a place that they would leave if they only could’, whereas queers who migrate to metropolitan centres are able to fully express their gender identity and sexuality (Halberstam, 2005: 36). Metronormativity significantly shapes LGBTIQA+ focused research, policy and service design, but falling outside this hegemonic frame are the complex ways that LGBTIQA+ people find a sense of place, forge connections and establish a sense of belonging in rural and regional areas.
Autistic children and young people (CYP) experience mental health difficulties but face many barriers to accessing and benefiting from mental health care. There is a need to explore strategies in mental health care for autistic CYP to guide clinical practice and future research and support their mental health needs. Our aim was to identify strategies used to improve mental health care for autistic CYP and examine evidence on their acceptability, feasibility, and effectiveness. A systematic review and meta-analysis were carried out. All study designs reporting acceptability/feasibility outcomes and empirical quantitative studies reporting effectiveness outcomes for strategies tested within mental health care were eligible. We conducted a narrative synthesis and separate meta-analyses by informant (self, parent, and clinician). Fifty-seven papers were included, with most investigating cognitive behavioral therapy (CBT)-based interventions for anxiety and several exploring service-level strategies, such as autism screening tools, clinician training, and adaptations regarding organization of services. Most papers described caregiver involvement in therapy and reported adaptations to communication and intervention content; a few reported environmental adjustments. In the meta-analyses, parent- and clinician-reported outcomes, but not self-reported outcomes, showed with moderate certainty that CBT for anxiety was an effective treatment compared to any comparison condition in reducing anxiety symptoms in autistic individuals. The certainty of evidence for effectiveness, synthesized narratively, ranged from low to moderate. Evidence for feasibility and acceptability tended to be positive. Many identified strategies are simple, reasonable adjustments that can be implemented in services to enhance mental health care for autistic individuals. Notable research gaps persist, however.
Findings from randomised controlled trials (RCTs) are synthesised through meta-analyses, which inform evidence-based decision-making. When key details regarding trial outcomes are not fully reported, knowledge synthesis and uptake of findings into clinical practice are impeded.
Aims
Our study assessed reporting of primary outcomes in RCTs for older adults with major depressive disorder (MDD).
Method
Trials published between 2011 and 2021, which assessed any intervention for adults aged ≥65 years with a MDD diagnosis, and that specified a single primary outcome were considered for inclusion in our study. Outcome reporting assessment was conducted independently and in duplicate with a 58-item checklist, used in developing the CONSORT-Outcomes statement, and information in each RCT was scored as ‘fully reported’, ‘partially reported’ or ‘not reported’, as applicable.
Results
Thirty-one of 49 RCTs reported one primary outcome and were included in our study. Most trials (71%) did not fully report over half of the 58 checklist items. Items pertaining to outcome analyses and interpretation were fully reported by 65% or more of trials. Items reported less frequently included: outcome measurement instrument properties (varied from 3 to 30%) and justification of the criteria used to define clinically meaningful change (23%).
Conclusions
There is variability in how geriatric depression RCTs report primary outcomes, with omission of details regarding measurement, selection, justification and definition of clinically meaningful change. Outcome reporting deficiencies may hinder replicability and synthesis efforts that inform clinical guidelines and decision-making. The CONSORT-Outcomes guideline should be used when reporting geriatric depression RCTs.
This article discusses ethical frameworks for planning and implementing composite research in the United States. Composites, defined here as archaeological materials with multiple genetic sources, include materials such as sediment, coprolites, birch pitch, and dental calculus. Although composites are increasingly used in genetic research, the ethical considerations of their use in ancient DNA studies have not been widely discussed. Here, we consider how composites’ compositions, contexts, and potential to act as proxies can affect research plans and offer an overview of the primary ethical concerns of ancient DNA research. It is our view that ethical principles established for analyses of Ancestral remains and related materials can be used to inform research plans when working with composite evidence. This work also provides a guide to archaeologists unfamiliar with genetics analyses in planning research when using composite evidence from the United States with a focus on collaboration, having a clear research plan, and using lab methods that provide the desired data with minimal destruction. Following the principles discussed in this article and others allows for engaging in composite research while creating and maintaining positive relationships with stakeholders.
OBJECTIVES/GOALS: Chronic low back pain (cLBP) is associated with gait impairments. Gait may serve as an important biomarker for improvement following therapy interventions; however, gait has not been sufficiently studied in relationship to pain and function in cLBP. METHODS/STUDY POPULATION: Adults with cLBP completed a two-minute-walk-test around a 37.5 m oval track while wearing an inertial measurement unit (IMU—Lifeware LLC, Pittsburgh, PA) over the L5 spinous process. Step time average, step time variability, step length, and symmetry (harmonic ratio) were calculated based on linear trunk accelerations, and gait speed was calculated based on distance walked. Participants completed the PEG tool (Pain, Enjoyment, General activity; scores closer to 10 indicate worse pain) to quantify pain intensity/interference and the PROMIS Physical Function SF-6b tool (mean t-scores=50 +/- 10; higher scores indicate better function) to quantify physical function. Pearson correlation coefficient (r) was used to determine strength of associations between gait and pain/physical function. RESULTS/ANTICIPATED RESULTS: Eleven adults (8 female, age 40 +/- 17, pain duration≥3 months) with cLPB participated in this study after completing an informed consent process approved by the University of Pittsburgh Institutional Review Board. Participants with a history of cancer, spinal cord compression, discitis, or activity restrictions prohibiting them from protocol completion were excluded. The mean PEG scores and PROMIS Physical Function t-scores were 2.8 +/- 1.8 and 47.8 +/- 8.2 respectively. There was a moderate-strong correlation between step time average and PEG (r=0.67, p=0.02), and a moderate-strong correlation between gait speed and PROMIS Physical Function (r=0.62, p=0.04). There were no other significant associations. DISCUSSION/SIGNIFICANCE: Gait speed and step time may be important movement biomarkers to consider when evaluating patients with cLBP. Generalizability of results are limited by the small study cohort and this cohort's relatively low pain burden and high level of physical function.
The cornerstone of obesity treatment is behavioural weight management, resulting in significant improvements in cardio-metabolic and psychosocial health. However, there is ongoing concern that dietary interventions used for weight management may precipitate the development of eating disorders. Systematic reviews demonstrate that, while for most participants medically supervised obesity treatment improves risk scores related to eating disorders, a subset of people who undergo obesity treatment may have poor outcomes for eating disorders. This review summarises the background and rationale for the formation of the Eating Disorders In weight-related Therapy (EDIT) Collaboration. The EDIT Collaboration will explore the complex risk factor interactions that precede changes to eating disorder risk following weight management. In this review, we also outline the programme of work and design of studies for the EDIT Collaboration, including expected knowledge gains. The EDIT studies explore risk factors and the interactions between them using individual-level data from international weight management trials. Combining all available data on eating disorder risk from weight management trials will allow sufficient sample size to interrogate our hypothesis: that individuals undertaking weight management interventions will vary in their eating disorder risk profile, on the basis of personal characteristics and intervention strategies available to them. The collaboration includes the integration of health consumers in project development and translation. An important knowledge gain from this project is a comprehensive understanding of the impact of weight management interventions on eating disorder risk.
Reward processing has been proposed to underpin the atypical social feature of autism spectrum disorder (ASD). However, previous neuroimaging studies have yielded inconsistent results regarding the specificity of atypicalities for social reward processing in ASD.
Aims
Utilising a large sample, we aimed to assess reward processing in response to reward type (social, monetary) and reward phase (anticipation, delivery) in ASD.
Method
Functional magnetic resonance imaging during social and monetary reward anticipation and delivery was performed in 212 individuals with ASD (7.6–30.6 years of age) and 181 typically developing participants (7.6–30.8 years of age).
Results
Across social and monetary reward anticipation, whole-brain analyses showed hypoactivation of the right ventral striatum in participants with ASD compared with typically developing participants. Further, region of interest analysis across both reward types yielded ASD-related hypoactivation in both the left and right ventral striatum. Across delivery of social and monetary reward, hyperactivation of the ventral striatum in individuals with ASD did not survive correction for multiple comparisons. Dimensional analyses of autism and attention-deficit hyperactivity disorder (ADHD) scores were not significant. In categorical analyses, post hoc comparisons showed that ASD effects were most pronounced in participants with ASD without co-occurring ADHD.
Conclusions
Our results do not support current theories linking atypical social interaction in ASD to specific alterations in social reward processing. Instead, they point towards a generalised hypoactivity of ventral striatum in ASD during anticipation of both social and monetary rewards. We suggest this indicates attenuated reward seeking in ASD independent of social content and that elevated ADHD symptoms may attenuate altered reward seeking in ASD.
Data suggest poorer bereavement outcomes for lesbian, gay and bisexual people, but this has not been estimated in population-based research. This study compared bereavement outcomes for partners of same-gender and different-gender decedents.
Methods
In this population-based, cross-sectional survey of people bereaved of a civil partner or spouse 6–10 months previously, we used adjusted logistic and linear regression to investigate outcomes of interest: (1) positive screen on Inventory of Complicated Grief (ICG), (2) positive screen on General Health Questionnaire (GHQ), (3) grief intensity (ICG) and (4) psychiatric symptoms (GHQ-12).
Results
Among 233 same-gender partners and 329 of different-gender partners, 66.1% [95% confidence interval (CI) 60.0–72.2] and 59.2% [95% CI (53.9–64.6)] respectively screened positive for complicated grief on the ICG, whilst 76.0% [95% CI (70.5–81.5)] and 69.3% [95% CI (64.3–74.3)] respectively screened positive on the GHQ-12. Same-gender bereaved partners were not significantly more likely to screen positive for complicated grief than different-gender partners [adjusted odds ratio (aOR) 1.56, 95% CI (0.98–2.47)], p = 0.059, but same-gender bereaved partners were significantly more likely to screen for psychiatric caseness [aOR 1.67 (1.02, 2.71) p = 0.043]. We similarly found no significant association of partner gender with grief intensity [B = 1.86, 95% CI (−0.91to 4.63), p = 0.188], but significantly greater psychological distress for same-gender partners [B = 1.54, 95% CI (−0.69–2.40), p < 0.001].
Conclusions
Same-gender bereaved partners report significantly more psychological distress. In view of their poorer sub-clinical mental health, clinical and bereavement services should refine screening processes to identify those at risk of poor mental health outcomes.
This research note reports on a new effort to track candidate diversity in Canadian elections. The dataset covers 4,516 candidates who ran in the 2008, 2011, 2015 and 2019 federal elections and includes novel data on their race, Indigenous background and age, alongside information on gender, occupation, prior electoral experience and electoral outcome. We outline the process for collecting and systematizing these data, which relied on genealogical methods and the principle of triangulation. The data can be used to track diversity among electoral candidates over time or merged with other sources to answer district-level questions about representational diversity, electoral dynamics, vote choice and political communications. The method could also be replicated and applied to other levels of government.
In March 2020, academic medical center (AMC) pharmacies were compelled to implement practice changes in response to the COVID-19 pandemic. These changes were described by survey data collected by the Clinical and Translational Science Awards (CTSA) program which were interpreted by a multi-institutional team of AMC pharmacists and physician investigators.
Methods:
The CTSA program surveyed 60 AMC pharmacy departments. The survey included event timing, impact on pharmacy services, and corrective actions taken.
Results:
Almost all departments (98.4%) reported at least one disruption. Shortages of personal protective equipment (PPE) were common (91.5%) as were drug shortages (66.0%). To manage drug shortages, drug prioritization protocols were utilized, new drug supply vendors were identified (79.3%), and onsite compounding was initiated. PPE shortages were managed by incorporating the risk mitigation strategies recommended by FDA and others. Research pharmacists supported new clinical research initiatives at most institutions (84.0%), introduced use of virtual site visits, and shipped investigational drugs directly to patients. Some pharmacies formulated novel investigational products for clinical trial use. Those AMC pharmacies within networked health systems assisted partner rural and inner-city hospitals by sourcing commercial and investigational drugs to alleviate local disease outbreaks and shortages in underserved populations. Pharmacy-based vaccination practice was expanded to include a wider range of pediatric and adult vaccines.
Conclusion:
The COVID-19 pandemic radically altered hospital pharmacy practice. By adopting innovative methods and adapting to regulatory imperatives, pharmacies at CTSA sites played an extremely important role supporting continuity of care and collaborating on critical clinical research initiatives.
Evidence is limited on how to synthesize and incorporate the views of stakeholders into a multisite pragmatic trial and how much academic teams change study design and protocol in response to stakeholder input. This qualitative study describes how stakeholders contributed to the design, conduct, and dissemination of findings of a multisite pragmatic clinical trial, the COMprehensive Post-Acute Stroke Services (COMPASS) Study. We engaged stakeholders as integral research partners by embedding them in study committees and community resource networks that supported local sites. Data stemmed from formal focus groups and continuous participation in working groups. Guided by Grounded Theory, we extracted themes from focus group and meeting notes. These were discussed as a team and with other stakeholder groups for feasibility. A consensus approach was used. Stakeholder input changed many aspects of the study including: the care model that treated stroke as a chronic condition after hospital discharge, training for hospital-based providers who often lacked awareness of the barriers to recovery that patients face, support for caregivers who were essential for stroke patients’ recovery, and for community-based health and social service providers whose services can support recovery yet often go underutilized. Stakeholders brought value to both pragmatic research and health service delivery. Future studies should test the impact of elements of study implementation informed by stakeholders vs those that are not.
Identifying developmental endophenotypes on the pathway between genetics and behavior is critical to uncovering the mechanisms underlying neurodevelopmental conditions. In this proof-of-principle study, we explored whether early disruptions in visual attention are a unique or shared candidate endophenotype of autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD). We calculated the duration of the longest look (i.e., peak look) to faces in an array-based eye-tracking task for 335 14-month-old infants with and without first-degree relatives with ASD and/or ADHD. We leveraged parent-report and genotype data available for a proportion of these infants to evaluate the relation of looking behavior to familial (n = 285) and genetic liability (using polygenic scores, n = 185) as well as ASD and ADHD-relevant temperament traits at 2 years of age (shyness and inhibitory control, respectively, n = 272) and ASD and ADHD clinical traits at 6 years of age (n = 94).
Results showed that longer peak looks at the face were associated with elevated polygenic scores for ADHD (β = 0.078, p = .023), but not ASD (β = 0.002, p = .944), and with elevated ADHD traits in mid-childhood (F(1,88) = 6.401, p = .013, $\eta _p^2$=0.068; ASD: F (1,88) = 3.218, p = .076), but not in toddlerhood (ps > 0.2). This pattern of results did not emerge when considering mean peak look duration across face and nonface stimuli. Thus, alterations in attention to faces during spontaneous visual exploration may be more consistent with a developmental endophenotype of ADHD than ASD. Our work shows that dissecting paths to neurodevelopmental conditions requires longitudinal data incorporating polygenic contribution, early neurocognitive function, and clinical phenotypic variation.
Despite their use in clinical practice, there is little evidence to support the use of therapist written goodbye letters as therapeutic tools. However, preliminary evidence suggests that goodbye letters may have benefits in the treatment of anorexia nervosa (AN).
Aims:
This study aimed to examine whether therapist written goodbye letters were associated with improvements in body mass index (BMI) and eating disorder symptomology in patients with AN after treatment.
Method:
Participants were adults with AN (n = 41) who received The Maudsley Model of Anorexia Treatment for Adults (MANTRA) in a clinical trial evaluating two AN out-patient treatments. As part of MANTRA, therapists wrote goodbye letters to patients. A rating scheme was developed to rate letters for structure and quality. Linear regression analyses were used to examine associations between goodbye letter scores and outcomes after treatment.
Results:
Higher quality letters and letters that adopted a more affirming stance were associated with greater improvements in BMI at 12 months. Neither the overall quality nor the style of goodbye letters were associated with improvements in BMI at 24 months or reductions in eating disorder symptomology at either 12 or 24 months.
Conclusions:
The results highlight the potential importance of paying attention to the overall quality of therapist written goodbye letters in the treatment of AN, and adopting an affirming stance.
Parent-adolescent conflict seems to be common when adolescents negotiate power with their parents. Forum theatre (FT), an interactive and participatory theatre form, is recommended as a community-based intervention to assist Chinese parents in managing the challenges of parent-adolescent interaction. FT proposes that solutions to daily struggles can be reached through concerted efforts of the participants. This article documents the impact of FT on parents who took on the role of ‘spect-actor’. The spect-actor is an active spectator who acts on stage to test solutions to a problem. The results indicate that parents gained more awareness of their children’s needs, which helped them to relax their control over their children. FT is recommended as a means of parent education in schools.
Dry eye disease (DED) is a common condition that significantly impacts patients’ quality of life. Previous studies have explored the impact of DED on patients’ lives qualitatively; however, patients’ preference structures have not been thoroughly explored quantitatively.
Methods:
A targeted literature review and social media listening project guided design of a discussion guide for in-depth patient interviews (n=12). These, in turn, guided construction of a quantitative questionnaire administered to moderate to severe DED patients, 40 per country in Australia, Germany, United States and United Kingdom (total n=160). Patients’ preference structures were explored through an online survey using a self-explicated conjoint methodology, because of its high respondent-friendliness. Additionally, we administered the EQ5D-5L instrument to determine the health states/utilities of patients. Reaction to a hypothetical novel treatment was further obtained to check for convergent validity with the self-explicated conjoint. Finally, we asked respondents to rate the ease and relevance of the questionnaire to them.
Results:
Qualitative research uncovered important patient perspectives that were built into the quantitative survey. For example, patients seek medical advice when their symptoms are not improving. Patients’ lives are most affected by sensitivity to light, itchy and tired eyes and an inability to perform computer/screen work; however, of most concern/worrying to them is that their DED will get worse and they go blind. Results from the quantitative preference research will also be shared and its implications for future clinical trials in DED outlined. The results of the patient research and preference study are to be shared with health technology assessment (HTA) bodies and regulators through the early dialogue scientific advice process.
Conclusions:
A process of using qualitative research to determine what matters to patients and then quantification through respondent-friendly preference research can identify outcomes that are most patient-relevant, to inform future drug development strategies.