Gut-microbiota-targeted diets modulate human immune status.

Diet modulates the gut microbiome, which in turn can impact the immune system. Here, we determined how two microbiota-targeted dietary interventions, plant-based fiber and fermented foods, influence the human microbiome and immune system in healthy adults. Using a 17-week randomized, prospective study (n = 18/arm) combined with -omics measurements of microbiome and host, including extensive immune profiling, we found diet-specific effects. The high-fiber diet increased microbiome-encoded glycan-degrading carbohydrate active enzymes (CAZymes) despite stable microbial community diversity. Although cytokine response score (primary outcome) was unchanged, three distinct immunological trajectories in high-fiber consumers corresponded to baseline microbiota diversity. Alternatively, the high-fermented-food diet steadily increased microbiota diversity and decreased inflammatory markers. The data highlight how coupling dietary interventions to deep and longitudinal immune and microbiome profiling can provide individualized and population-wide insight. Fermented foods may be valuable in countering the decreased microbiome diversity and increased inflammation pervasive in industrialized society.

Unraveling sex-specific risks of knee osteoarthritis before menopause: Do sex differences start early in life?

OBJECTIVE: Sufficient evidence within the past two decades have shown that osteoarthritis (OA) has a sex-specific component. However, efforts to reveal the biological causes of this disparity have emerged more gradually. In this narrative review, we discuss anatomical differences within the knee, incidence of injuries in youth sports, and metabolic factors that present early in life (childhood and early adulthood) that can contribute to a higher risk of OA in females. DESIGN: We compiled clinical data from multiple tissues within the knee joint-since OA is a whole joint disorder-aiming to reveal relevant factors behind the sex differences from different perspectives. RESULTS: The data gathered in this review indicate that sex differences in articular cartilage, meniscus, and anterior cruciate ligament are detected as early as childhood and are not only explained by sex hormones. Aiming to unveil the biological causes of the uneven sex-specific risks for knee OA, we review the current knowledge of sex differences mostly in young, but also including old populations, from the perspective of (i) human anatomy in both healthy and pathological conditions, (ii) physical activity and response to injury, and (iii) metabolic signatures. CONCLUSIONS: We propose that to close the gap in health disparities, and specifically regarding OA, we should address sex-specific anatomic, biologic, and metabolic factors at early stages in life, as a way to prevent the higher severity and incidence of OA in women later in life.

7 T characterization of excitatory and inhibitory systems of acute pain in healthy female participants.

Current understanding of the physiological underpinnings of normative pain processing is incomplete. Enhanced knowledge of these systems is necessary to advance our understanding of pain processes as well as to develop effective therapeutic interventions. Previous neuroimaging research suggests a network of interrelated brain regions that seem to be implicated in the processing and experience of pain. Among these, the dorsal anterior cingulate cortex (dACC) plays an important role in the affective aspects of pain signals. The current study leveraged functional MRS to investigate the underlying dynamic shifts in the neurometabolic signature of the human dACC at rest and during acute pain. Results provide support for increased glutamate levels following acute pain administration. Specifically, a 4.6% increase in glutamate was observed during moderate pressure pain compared with baseline. Exploratory analysis also revealed meaningful changes in dACC gamma aminobutyric acid in response to pain stimulation. These data contribute toward the characterization of neurometabolic shifts, which lend insight into the role of the dACC in the pain network. Further research in this area with larger sample sizes could contribute to the development of novel therapeutics or other advances in pain-related outcomes.

Effect of Maternal Race, Residential Rurality, and Social Vulnerability on Critical Congenital Heart Defect Risk.

The development of a congenital heart defect (CHD) is multifactorial, with many cases having an unknown etiology. This study explored whether maternal race and lived environment were associated with an infant being born with a critical CHD. A cross-sectional, case-control design was conducted utilizing secondary data analysis. The CHD group (N = 199) consisted of infants diagnosed with a critical CHD within the first year of life identified from hospital databases. The non-CHD group (N = 548) was a random sample of infants selected from the state's vital statistics database. The primary outcome was a critical CHD diagnosis. Maternal race, residential rurality, and the Social Vulnerability Index (SVI) were assessed for associations with a critical CHD using bivariate and multilevel regression models. Bivariate findings reported significance among residential rurality (p < 0.001), SVI ranking overall (p = 0.017), and SVI by theme (theme 1 p = 0.004, theme 2 p < 0.001, theme 3 p = 0.007, and theme 4 p = 0.049) when comparing infants with and without a critical CHD diagnosis. Results of multilevel logistic regression analyses further identified living in a rural residential area compared to urban areas (OR = 7.32; p < 0.001) as a predictor for a critical CHD diagnosis. The findings of lived environmental level associations provides information needed for continued investigation as the burden of a critical CHD continues to impact families, suggesting further research efforts are needed to improve health disparities.

Gated transformations from egocentric to allocentric reference frames involving retrosplenial cortex, entorhinal cortex, and hippocampus.

This paper reviews the recent experimental finding that neurons in behaving rodents show egocentric coding of the environment in a number of structures associated with the hippocampus. Many animals generating behavior on the basis of sensory input must deal with the transformation of coordinates from the egocentric position of sensory input relative to the animal, into an allocentric framework concerning the position of multiple goals and objects relative to each other in the environment. Neurons in retrosplenial cortex show egocentric coding of the position of boundaries in relation to an animal. These neuronal responses are discussed in relation to existing models of the transformation from egocentric to allocentric coordinates using gain fields and a new model proposing transformations of phase coding that differ from current models. The same type of transformations could allow hierarchical representations of complex scenes. The responses in rodents are also discussed in comparison to work on coordinate transformations in humans and non-human primates.

Tissue-mimetic culture enhances mesenchymal stem cell secretome capacity to improve regenerative activity of keratinocytes and fibroblasts in vitro.

Mesenchymal stem/stromal cells (MSCs) are a heterogenous population of multipotent and highly secretory cells currently being investigated in the field of wound healing for their ability to augment tissue responses. The adaptive response of MSC populations to the rigid substrate of current 2D culture systems has been considered to result in a deterioration of regenerative 'stem-like' properties. In this study, we characterise how the improved culture of adipose-derived mesenchymal stem cells (ASCs) within a tissue-mimetic 3D hydrogel system, that is mechanically similar to native adipose tissue, enhances their regenerative capabilities. Notably, the hydrogel system contains a porous microarchitecture that permits mass transport, enabling efficient collection of secreted cellular compounds. By utilising this 3D system, ASCs retained a significantly higher expression of ASC 'stem-like' markers while demonstrating a significant reduction in senescent populations, relative to 2D. Additionally, culture of ASCs within the 3D system resulted in enhanced secretory activity with significant increases in the secretion of proteinaceous factors, antioxidants and extracellular vesicles (EVs) within the conditioned media (CM) fraction. Lastly, treatment of wound healing cells, keratinocytes (KCs) and fibroblasts (FBs), with ASC-CM from the 2D and 3D systems resulted in augmented functional regenerative activity, with ASC-CM from the 3D system significantly increasing KC and FB metabolic, proliferative and migratory activity. This study demonstrates the potential beneficial role of MSC culture within a tissue-mimetic 3D hydrogel system that more closely mimics native tissue mechanics, and subsequently how the improved phenotype augments secretory activity and potential wound healing capabilities of the MSC secretome.

"I Need to Get My Culture Back": Youth and Provider Perspectives on Integrating Culturally Based Approaches into Sexual and Reproductive Health Programs for Native Hawaiian and Pacific Islander Youth Experiencing Homelessness.

There is growing interest in decolonizing sexual and reproductive health (SRH) and embedding cultural practices into social and medical services in Hawai'i. Wahine ("woman") Talk is a multilevel, comprehensive SRH program for female youth experiencing homelessness (YEH) led by community health, social work, and medical providers. This study examines youth and program provider perspectives of culturally based approaches that may strengthen SRH programs. The study team conducted three focus groups and ten in-depth interviews with participating youth and program providers after the program's conclusion. Youth participants were aged 14 to 22 years (M = 18.1) and of Native Hawaiian or Pacific Islander ancestry. Interview transcripts were analyzed using structured thematic analysis. The youth described feeling estranged from their ancestral cultures and suggested incorporating multiple cultural practices to enhance their connection to community, body, and land into SRH programming for YEH. They identified several 'aina ("land")-based approaches, hands-on learning, hula, and language as possible practices to weave into the program. While youth felt estranged from their ancestral cultures, they discussed Native Hawaiian and Pacific Islander health perspectives where 'aina and relationships are considered life-sustaining. Youth and program staff stressed incorporating culture respectfully, caring for the whole person, and providing trauma-informed care. Future policy, practice, and research should consider protecting and integrating Native Hawaiian conceptions of health into SRH policy and practice and include youths' cultural identities in SRH intervention development.

Experiences of the COVID-19 pandemic among young parents with foster care backgrounds: A participatory action PhotoVoice study.

The COVID-19 pandemic has had a disproportionate impact on many vulnerable populations, including youth in foster care and parents of young children. In this study, we worked with nine parenting current and former foster youth to share their experiences of the COVID-19 pandemic through photography. Data were collected between January and March 2021 during a series of three virtual PhotoVoice sessions, then transcripts of PhotoVoice sessions and participant-selected captioned photographs were analyzed using thematic analysis. Themes in participants' photographs included 1) Pandemic Parenting and 2) Making the Best of It. Findings indicate the need to expand mental health services, protect essential workers, and ensure young parents receive support navigating medical and social welfare systems and the process of receiving pandemic relief-related benefits.

Functional parcellation of the hippocampus based on its layer-specific connectivity with default mode and dorsal attention networks.

Recent neuroimaging evidence suggests that there might be an anterior-posterior functional differentiation of the hippocampus along the long-axis. The HERNET (hippocampal encoding/retrieval and network) model proposed an encoding/retrieval dichotomy with the anterior hippocampus more connected to the dorsal attention network (DAN) during memory encoding, and the posterior portions more connected to the default mode network (DMN) during retrieval. Evidence both for and against the HERNET model has been reported. In this study, we test the validity of the HERNET model non-invasively in humans by computing functional connectivity (FC) in layer-specific cortico-hippocampal microcircuits. This was achieved by acquiring sub-millimeter functional magnetic resonance imaging (fMRI) data during encoding/retrieval tasks at 7T. Specifically, FC between infra-granular output layers of DAN with hippocampus during encoding and FC between supra-granular input layers of DMN with hippocampus during retrieval were computed to test the predictions of the HERNET model. Our results support some predictions of the HERNET model including anterior-posterior gradient along the long axis of the hippocampus. While preferential relationships between the entire hippocampus and DAN/DMN during encoding/retrieval, respectively, were observed as predicted, anterior-posterior specificity in these network relationships could not be confirmed. The strength and clarity of evidence for/against the HERNET model were superior with layer-specific data compared to conventional volume data.

Pharmacogenetics of interaction between depot medroxyprogesterone acetate and efavirenz, rifampicin, and isoniazid during treatment of HIV and tuberculosis.

OBJECTIVE: In AIDS Clinical Trials Group study A5338, concomitant rifampicin, isoniazid, and efavirenz was associated with more rapid plasma medroxyprogesterone acetate (MPA) clearance compared to historical controls without tuberculosis or HIV therapy. We characterized the pharmacogenetics of this interaction. METHODS: In A5338, women receiving efavirenz-based HIV therapy and rifampicin plus isoniazid for tuberculosis underwent pharmacokinetic evaluations over 12 weeks following a 150-mg intramuscular injection of depot MPA. Data were interpreted with nonlinear mixed-effects modelling. Associations between individual pharmacokinetic parameters and polymorphisms relevant to rifampicin, isoniazid, efavirenz, and MPA were assessed. RESULTS: Of 62 A5338 participants in four African countries, 44 were evaluable for pharmacokinetic associations, with 17 CYP2B6 normal, 21 intermediate, and 6 poor metabolizers, and 5 NAT2 rapid, 20 intermediate, and 19 slow acetylators. There were no associations between either CYP2B6 or NAT2 genotype and MPA Cmin at week 12, apparent clearance, Cmax, area under the concentration-time curve (AUC) or half-life, or unexplained interindividual variability in clearance, and uptake rate constant or mean transit time of the slow-release fraction (P > 0.05 for each). In exploratory analyses, none of 28 polymorphisms in 14 genes were consistently associated with MPA pharmacokinetic parameters, and none withstood correction for multiple testing. CONCLUSIONS: Study A5338 suggested that more frequent depot MPA dosing may be appropriate for women receiving rifampicin, isoniazid, and efavirenz. The present results suggest that knowledge of CYP2B6 metabolizer or NAT2 acetylator status does not inform individualized DMPA dosing in this setting.

Producing personalized statin treatment plans to optimize clinical outcomes using big data and machine learning.

Almost half of Americans 65 years of age and older take statins, which are highly effective in lowering low-density lipoprotein cholesterol, preventing atherosclerotic cardiovascular disease (ASCVD), and reducing all-cause mortality. Unfortunately, ∼50% of patients prescribed statins do not obtain these critical benefits because they discontinue use within one year of treatment initiation. Therefore, statin discontinuation has been identified as a major public health concern due to the increased morbidity, mortality, and healthcare costs associated with ASCVD. In clinical practice, statin-associated symptoms (SAS) often result in dose reduction or discontinuation of these life-saving medications. Currently, physician decision-making in statin prescribing typically relies on only a few patient data elements. Physicians then employ reactive strategies to manage SAS concerns after they manifest (e.g., offering an alternative statin treatment plan or a statin holiday). A preferred approach would be a proactive strategy to identify the optimal treatment plan (statin agent + dosage) to prevent/minimize SAS and statin discontinuation risks for a particular individual prior to initiating treatment. Given that using a single patient's data to identify the optimal statin regimen is inadequate to ensure that the harms of statin use are minimized, alternative tactics must be used to address this problem. In this proof-of-concept study, we explore the use of a machine-learning personalized statin treatment plan (PSTP) platform to assess the numerous statin treatment plans available and identify the optimal treatment plan to prevent/minimize harms (SAS and statin discontinuation) for an individual. Our study leveraged de-identified administrative insurance claims data from the OptumLabs® Data Warehouse, which includes medical and pharmacy claims, laboratory results, and enrollment records for more than 130 million commercial and Medicare Advantage (MA) enrollees, to successfully develop the PSTP platform. In this study, we found three results: (1) the PSTP platform recommends statin prescription with significantly lower risks of SAS and discontinuation compared with standard-practice, (2) because machine learning can consider many more dimensions of data, the performance of the proactive prescription strategy with machine-learning support is better, especially the artificial neural network approach, and (3) we demonstrate a method of incorporating optimization constraints for individualized patient-centered medicine and shared decision making. However, more research into its clinical use is needed. These promising results show the feasibility of using machine learning and big data approaches to produce personalized healthcare treatment plans and support the precision-health agenda.

SWAP-MEAT Athlete (study with appetizing plant-food, meat eating alternatives trial) - investigating the impact of three different diets on recreational athletic performance: a randomized crossover trial.

BACKGROUND: Plant-based diets are known to be beneficial for cardiovascular health and promote environmental sustainability. However, many athletes avoid plant-based diets due to concerns of protein inadequacy. OBJECTIVES: To investigate the impact of two predominately plant-based diets-whole food plant-based (WFPB) and plant-based meat alternatives (PBMA)-vs. an omnivorous diet, favoring red meat and poultry (Animal), on endurance and muscular strength. METHODS: 12 recreational runners and 12 resistance trainers were assigned to three diets-WFPB, PBMA, and Animal-for 4 weeks each, in random order. Primary outcomes for runners (12-minute timed run) and resistance trainers (composite machine strength) were collected at baseline and after diets, along with secondary performance outcomes and dietary data. RESULTS: 22 recreational athletes completed the study (age: 26.2 ± 4.4 years; sex: 10 female, 12 male; BMI: 23.1 ± 2.4 kg/m2). Mean differences in 12-minute timed run - WFPB vs. Animal (- 23.4 m; 95% CI: - 107 to 60.0 m) and PBMA vs. Animal (- 2.9 m; 95% CI: - 119 to 113 m) - were not significant. Mean percent differences in composite machine strength - WFPB vs. Animal (- 2.7%; 95% CI: - 5.8 to 0.4% and PBMA vs. Animal (- 0.7%; 95% CI: - 3.5 to 2.2%) - were not significant. Average protein intake for all diets met International Society for Sports Nutrition recommendations. CONCLUSIONS: Our findings suggest recreational athletes can maintain athletic performance on both an omnivorous diet and two diets that are predominately plant-based. TRIAL REGISTRATION: NCT05472701. Retrospectively registered.

Self-controlled assessment of thromboembolic event (TEE) risk following intravenous immune globulin (IGIV) in the U.S. (2006-2012).

Since 2013, the U.S. Food and Drug administration (FDA) has required that intravenous immune globulin (IGIV) products carry a boxed warning concerning the risk of thromboembolic events (TEEs). This study assessed the incidence of TEEs attributable to IGIV in a large population-based cohort. A self-controlled risk interval design was used to quantify the transient increase in TEE risk during the risk interval (days 0-2 and 0-13 following IGIV for arterial and venous TEEs, respectively) relative to a later control interval (days 14-27 following IGIV). Potential IGIV-exposed TEE cases from 2006 to 2012 were identified from the FDA-sponsored Sentinel Distributed Database and confirmed through medical record review. Inpatient IGIV exposures were not included in the venous TEE analysis due to concerns about time-varying confounding. 19,069 new users of IGIV who received 93,555 treatment episodes were included. Charts were retrieved for 62% and 70% of potential venous and arterial cases, respectively. There was a transient increase in the risk of arterial TEEs during days 0-2 following IGIV treatment (RR = 4.69; 95% CI 1.87, 11.90; absolute increase in risk = 8.86 events per 10,000 patients, 95% CI 3.25, 14.6), but no significant increase in venous TEE risk during days 0-13 following outpatient IGIV treatments (RR = 1.07, 95% CI 0.34, 3.48). Our results suggest there is a small increase in the absolute risk of arterial TEEs following IGIV. However, lower-than-expected chart retrieval rates and the possibility of time-varying confounding mean that our results should be interpreted cautiously. Continued pharmacovigilance efforts are warranted.

Using the multiphase optimization strategy (MOST) framework to optimize an intervention to increase COVID-19 testing for Black and Latino/Hispanic frontline essential workers: A study protocol.

BACKGROUND: Among those at highest risk for COVID-19 exposure is the large population of frontline essential workers in occupations such food service, retail, personal care, and in-home health services, among whom Black and Latino/Hispanic persons are over-represented. For those not vaccinated and at risk for exposure to COVID-19, including frontline essential workers, regular (approximately weekly) COVID-19 testing is recommended. However, Black and Latino/Hispanic frontline essential workers in these occupations experience serious impediments to COVID-19 testing at individual/attitudinal- (e.g., lack of knowledge of guidelines), social- (e.g., social norms), and structural-levels of influence (e.g., poor access), and rates of testing for COVID-19 are insufficient. METHODS/DESIGN: The proposed community-engaged study uses the multiphase optimization strategy (MOST) framework and an efficient factorial design to test four candidate behavioral intervention components informed by an integrated conceptual model that combines critical race theory, harm reduction, and self-determination theory. They are A) motivational interview counseling, B) text messaging grounded in behavioral economics, C) peer education, and D) access to testing (via navigation to an appointment vs. a self-test kit). All participants receive health education on COVID-19. The specific aims are to: identify which components contribute meaningfully to improvement in the primary outcome, COVID-19 testing confirmed with documentary evidence, with the most effective combination of components comprising an "optimized" intervention that strategically balances effectiveness against affordability, scalability, and efficiency (Aim 1); identify mediators and moderators of the effects of components (Aim 2); and use a mixed-methods approach to explore relationships among COVID-19 testing and vaccination (Aim 3). Participants will be N = 448 Black and Latino/Hispanic frontline essential workers not tested for COVID-19 in the past six months and not fully vaccinated for COVID-19, randomly assigned to one of 16 intervention conditions, and assessed at 6- and 12-weeks post-baseline. Last, N = 50 participants will engage in qualitative in-depth interviews. DISCUSSION: This optimization trial is designed to yield an effective, affordable, and efficient behavioral intervention that can be rapidly scaled in community settings. Further, it will advance the literature on intervention approaches for social inequities such as those evident in the COVID-19 pandemic. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05139927 ; Registered on 11/29/2021. Protocol version 1.0. May 2, 2022, Version 1.0.

Relationship Between Environmental Air Quality and Congenital Heart Defects.

BACKGROUND: Congenital heart defects (CHDs) affect 40,000 U.S. infants annually. One fourth of these infants have a critical CHD, requiring intervention within the first year of life for survival. Over 80% of CHDs have an unknown etiology. Fine particulate matter ≤2.5 (PM2.5) and ozone (O3) may be air pollutants associated with CHD. OBJECTIVES: The purpose of this study was to explore relationships between first-trimester maternal exposure to air pollutants PM2.5 and O3 and a critical CHD diagnosis. METHODS: A retrospective cohort study with nested case controls was conducted using data from January 1, 2014, to December 31, 2016, and consisted of 199 infants with a diagnosed critical CHD and 550 controls. Air pollution data were obtained from the U.S. Environmental Protection Agency air monitors. Geographic information system software was used to geocode monitoring stations and infant residential locations. Data analysis included frequencies, chi-square, independent t-test analysis, and binary logistic regression for two time periods: the entire first trimester (Weeks 1-12) and the critical exposure window (Weeks 3-8 gestation). RESULTS: Critical CHD odds were not significantly increased by exposure during the first trimester. However, weekly analyses revealed CHD odds were higher in Weeks 5 and 8 as PM2.5 increased and decreased in Week 11 with increased O3 exposure. DISCUSSION: Our study shows no evidence to support the overall association between air pollutants PM2.5 and O3 and a critical CHD diagnosis. However, analyses by week suggested vulnerability in certain weeks of gestation and warrant additional surveillance and study.

Observed behaviours and suicide assessment language post-Mental Health First Aid training in Australia and the United States: a mixed methods study using discourse analysis.

BACKGROUND: Mental Health First Aid (MHFA) training teaches participants how to respond to mental health crises, including suicide. Little is known about the impact of training on participants' observed MHFA behaviours. This exploratory study aimed to compare MHFA-trained Australian and US student pharmacists' performance and suicide assessment language during simulated patient role-play (SPRP) assessments. METHODS: Student pharmacists (n = 265) completed MHFA training and participated (n = 81) in SPRPs with simulated patients (SP) who were people with lived experience of mental illness. Each SPRP was marked by three raters (student, tutor and SP). One-way ANOVA, chi-squared tests and independent samples t-tests were used to compare scores and pass/fail rates, where appropriate. Transcribed audio-recordings of suicide assessments underwent discourse analysis. A chi-squared test was conducted to investigate the differences in how suicide assessment language was coded across six discursive frames ('confident'/'timid', 'empathetic'/'apathetic', and 'direct'/'indirect'). RESULTS: Three raters assessed 81 SPRPs, resulting in quantitative analysis of 243 rubrics. There were no significant differences between student pharmacists' mean scores and pass/fail rates across countries. Overall, both cohorts across Australia and the US performed better during the mania scenario, with a low failure rate of 13.9 and 19.0%, respectively. Most students in both countries passed their SPRP assessment; however, 27.8% did not assess for suicide or used indirect language during suicide assessment, despite completing MHFA training. Australian student pharmacists demonstrated, more direct language (76.9% versus 67.9%) and empathy (42.3% versus 32.1%) but less confidence (57.7% versus 60.7%) compared to US student pharmacists, during their suicide assessment; however, these differences were not statistically significant. CONCLUSIONS: Findings indicate most MHFA-trained student pharmacists from Australia and the US can provide MHFA during SPRPs, as well as assess for suicide directly, empathetically and confidently. This exploratory study demonstrates the importance of practicing skills post-training and the need for further research exploring participants' hesitance to assess for suicide, despite training completion.

The influence of social support on cognitive health in older women: a Women's Health Initiative study.

Social support is associated prospectively with cognitive decline and dementia among the elderly; however, little is known about the impact of social support on healthy neurological aging. The current study investigates whether perceived social support has an influence on neurological health among a large sample of healthy postmenopausal women. Social support and neuropsychological outcomes were measured annually for six years through the Women's Health Initiative Study of Cognitive Aging. In postmenopausal women, higher perceived social support was associated with significantly better overall neuropsychological functioning at baseline, especially in the domains of short-delay figural memory, short-delay verbal memory, and semantic fluency. No significant associations were found between social support and longitudinal changes in neuropsychological function over a median follow-up period of six years. Additionally, there was no significant relationship between social support and regional brain volumes. These findings suggest that social support is related to performance in a subset of neuropsychological domains and contributes to the existing literature that points to the importance of social support as a modifiable lifestyle factor that has the potential to help protect against the decline of cognitive aging, specifically among older adult women.

A call to action: Community pharmacists to address COVID-19-related behavioral health concerns.

Owing to the extended nature and worldwide exposure of the coronavirus disease (COVID-19) pandemic, it is likely that the presence and impact of behavioral health conditions will increase. For example, it is anticipated that individuals living with a major depressive disorder could reach as high as 60% of the population owing to the ongoing disruption from COVID-19. In 2017, the annual rate of individuals experiencing a major depressive episode was only 7.1%. Pharmacists, specifically community pharmacists, are well positioned to provide needed intervention and triage services to individuals living with, and struggling with, a mental health condition. Pharmacists, therefore, need additional training and support to be effective in serving the community in this way.

A systematic review of patient interactions with student pharmacists in educational settings.

BACKGROUND: Patients may contribute to various aspects of student pharmacists' education within clinical, experiential and educational settings. There is an emerging body of literature describing and evaluating the contribution of patients to health care education; however, little is known about patients' contribution to pharmacy education specifically within educational settings. OBJECTIVE: To explore the evidence relating to the involvement of patients in the education of student pharmacists, in terms of the nature, extent, and outcomes of their contribution. METHODS: A systematic literature search was undertaken within Embase, MEDLINE, Education Resources Information Center, International Pharmaceutical Abstracts, PubMed, PsycINFO, CINAHL, and Scopus databases from inception to April 10, 2020. Inclusion criteria included primary research studies reporting on the active involvement of patients in pharmacy education, within an educational setting. Quality assessment appraisal for the included studies was conducted using the Mixed Methods Appraisal Tool. RESULTS: Twelve studies were eligible for inclusion in this systematic review. Nine studies explored the use of patients as educators providing valuable insight about their lived experience. Six studies involved patients in question-and-answer sessions, providing students with opportunities to inquire about their lived experience in relation to medicines, health care, and medical conditions. Studies that reported on students' learning outcomes demonstrated improvements in communication skills, deeper understanding of patients' lived experience particularly relating to mental illness, and increased confidence in providing care for patients. Among patients, participation in the educational process led to greater satisfaction, empowerment, and knowledge from sharing personal experiences. There were no clinical outcomes measured among patients participating in the included studies. The 5 nonrandomized quantitative studies ranged from low to moderate levels of quality, the 4 mixed-methods studies were of low quality, and the 3 qualitative studies were of high quality. CONCLUSION: The involvement of patients in the education of student pharmacists was found to benefit both patients and students. Student-specific outcomes included development of communication skills and new insights about patients' lived experience. Further research is needed to better understand the long-term impact of patient involvement in pharmacy education, in terms of students' learning outcomes and clinical outcomes among patients.

To Trial or Not to Trial Before Spinal Cord Stimulation for Chronic Neuropathic Pain: The Patients' View From the TRIAL-STIM Randomized Controlled Trial.

Objectives Spinal cord stimulation (SCS) is an established treatment of chronic neuropathic pain. Although a temporary SCS screening trial is widely used to determine suitability for a permanent implant, its evidence base is limited. The recent TRIAL-STIM study (a randomized controlled trial at three centers in the United Kingdom) found no evidence that an SCS screening trial strategy provides superior patient outcomes as compared with a no trial approach. As part of the TRIAL-STIM study, we undertook a nested qualitative study to ascertain patients' preferences in relation to undergoing a screening trial or not. Materials and Methods We interviewed 31 patients sampled from all three centers and both study arms (screening trial/no trial) prior to SCS implantation, and 23 of these patients again following implantation (eight patients were lost to follow-up). Interviews were undertaken by telephone and audio-recorded, then transcripts were subject to thematic analysis. In addition, participants were asked to state their overall preference for a one-stage (no screening trial) versus two-stage (screening trial) implant procedure on a five-point Likert scale, before and after implantation. Results Emergent themes favoured the option for a one-stage SCS procedure. Themes identified include: saving time (off work, in hospital, attending appointments), avoiding the worry about having "loose wires" in the two-stage procedure, having only one period of recovery, and saving NHS resources. Participants' rated preferences show similar support for a one-stage procedure without a screening trial. Conclusions Our findings indicate an overwhelming preference among participants for a one-stage SCS procedure both before and after the implant, regardless of which procedure they had undergone. The qualitative study findings further support the TRIAL-STIM RCT results.