Structural Competency in Simulation-Based Health Professions Education: A Call to Action and Pragmatic Guide.

SUMMARY STATEMENT: Simulation-based health professions educators can advance diversity, equity, and inclusion by cultivating structural competency, which is the trained ability to discern inequity not only at an individual level, but also at organizational, community, and societal levels. This commentary introduces Metzl and Hansen's Five-Step Model for structural competency and discusses its unique applicability to the metacognitive underpinnings of simulation-based health professions education. We offer a pragmatic guide for simulation-based health professions educators to collaboratively design learning objectives, simulation cases, character sketches, and debriefs in which structural competency is a simulation performance domain, alongside patient management, resource usage, leadership, situational awareness, teamwork, and/or communication. Our overall goal is to promote a paradigm shift in which educators are empowered to partner with patients, colleagues, and communities to recognize, learn about, and challenge the factors driving health inequities; a skill that may be applied to a broad range of health professions education within and outside of simulation.

Sertraline for anxiety in adults with a diagnosis of autism (STRATA): study protocol for a pragmatic, multicentre, double-blind, placebo-controlled randomised controlled trial.

BACKGROUND: Selective serotonin reuptake inhibitors (SSRIs) are commonly prescribed to manage anxiety in adults with an autism diagnosis. However, their effectiveness and adverse effect profile in the autistic population are not well known. This trial aims to determine the effectiveness and cost-effectiveness of the SSRI sertraline in reducing symptoms of anxiety and improving quality of life in adults with a diagnosis of autism compared with placebo and to quantify any adverse effects. METHODS: STRATA is a two-parallel group, multi-centre, pragmatic, double-blind, randomised placebo-controlled trial with allocation at the level of the individual. It will be delivered through recruiting sites with autism services in 4 regional centres in the United Kingdom (UK) and 1 in Australia. Adults with an autism diagnosis and a Generalised Anxiety Disorder Assessment (GAD-7) score ≥ 10 at screening will be randomised 1:1 to either 25 mg sertraline or placebo, with subsequent flexible dose titration up to 200 mg. The primary outcome is GAD-7 scores at 16 weeks post-randomisation. Secondary outcomes include adverse effects, proportionate change in GAD-7 scores including 50% reduction, social anxiety, obsessive-compulsive symptoms, panic attacks, repetitive behaviours, meltdowns, depressive symptoms, composite depression and anxiety, functioning and disability and quality of life. Carer burden will be assessed in a linked carer sub-study. Outcome data will be collected using online/paper methods via video call, face-to-face or telephone according to participant preference at 16, 24 and 52 weeks post-randomisation, with brief safety checks and data collection at 1-2, 4, 8, 12 and 36 weeks. An economic evaluation to study the cost-effectiveness of sertraline vs placebo and a QuinteT Recruitment Intervention (QRI) to optimise recruitment and informed consent are embedded within the trial. Qualitative interviews at various times during the study will explore experiences of participating and taking the trial medication. DISCUSSION: Results from this study should help autistic adults and their clinicians make evidence-based decisions on the use of sertraline for managing anxiety in this population. TRIAL REGISTRATION: ISRCTN, ISRCTN15984604 . Registered on 08 February 2021. EudraCT 2019-004312-66. ANZCTR ACTRN12621000801819. Registered on 07 April 2021.

Trauma-specific mindfulness-based cognitive therapy for women with post-traumatic stress disorder and a history of domestic abuse: intervention refinement and a randomised feasibility trial (coMforT study).

BACKGROUND: Women who have experienced domestic violence and abuse (DVA) are at increased risk of developing post-traumatic stress disorder (PTSD) and complex PTSD (CPTSD). In 2014-2015, we developed a prototype trauma-specific mindfulness-based cognitive therapy curriculum (TS-MBCT) for the treatment of PTSD in a DVA population. This study aimed to refine the prototype TS-MBCT and evaluate the feasibility of conducting a randomised controlled trial (RCT) testing its effectiveness and cost-effectiveness. METHODS: Intervention refinement phase was informed by evidence synthesis from a literature review, qualitative interviews with professionals and DVA survivors, and a consensus exercise with experts in trauma and mindfulness. We tested the refined TS-MBCT intervention in an individually randomised parallel group feasibility trial with pre-specified progression criteria, a traffic light system, and embedded process and health economics evaluations. RESULTS: The TS-MBCT intervention consisted of eight group sessions and home practice. We screened 109 women in a DVA agency and recruited 20 (15 TS-MBCT, 5 self-referral to National Health Service (NHS) psychological treatment), with 80% follow-up at 6 months. Our TS-MBCT intervention had 73% uptake, 100% retention, and high acceptability. Participants suggested recruitment via multiple agencies, and additional safety measures. Randomisation into the NHS control arm did not work due to long waiting lists and previous negative experiences. Three self-administered PTSD/CPTSD questionnaires produced differing outcomes thus a clinician administered measure might work better. We met six out of nine feasibility progression criteria at green and three at amber targets demonstrating that it is possible to conduct a full-size RCT of the TS-MBCT intervention after making minor amendments to recruitment and randomisation procedures, the control intervention, primary outcomes measures, and intervention content. At 6 months, none of the PTSD/CPTSD outcomes ruled out a clinically important difference between trial arms indicating that it is reasonable to proceed to a full-size RCT to estimate these outcomes with greater precision. CONCLUSIONS: A future RCT of the coMforT TS-MBCT intervention should have an internal pilot, recruit from multiple DVA agencies, NHS and non-NHS settings, have an active control psychological treatment, use robust randomisation and safety procedures, and clinician-administered measures for PTSD/CPTSD. TRIAL REGISTRATION: ISRCTN64458065 11/01/2019.

Integrated therapist and online CBT for depression in primary care (INTERACT): study protocol for a multi-centre randomised controlled trial.

BACKGROUND: Cognitive behavioural therapy (CBT) is an effective treatment for depression. Self-directed online CBT interventions have made CBT more accessible at a lower cost. However, adherence is often poor and, in the absence of therapist support, effects are modest and short-term. Delivering CBT online using instant messaging is clinically and cost-effective; however, most existing platforms are limited to instant messaging sessions, without the support of between-session "homework" activities. The INTERACT intervention integrates online CBT materials and 'high-intensity' therapist-led CBT, delivered remotely in real-time. The INTERACT trial will evaluate this novel integration in terms of clinical and cost-effectiveness, and acceptability to therapists and clients. METHODS: Pragmatic, two parallel-group multi-centre individually randomised controlled trial, with 434 patients recruited from primary care practices in Bristol, London and York. Participants with depression will be identified via General Practitioner record searches and direct referrals. INCLUSION CRITERIA: aged ≥ 18 years; score ≥ 14 on Beck Depression Inventory (BDI-II); meeting International Classification of Diseases (ICD-10) criteria for depression. EXCLUSION CRITERIA: alcohol or substance dependency in the past year; bipolar disorder; schizophrenia; psychosis; dementia; currently under psychiatric care for depression (including those referred but not yet seen); cannot complete questionnaires unaided or requires an interpreter; currently receiving CBT/other psychotherapy; received high-intensity CBT in the past four years; participating in another intervention trial; unwilling/unable to receive CBT via computer/laptop/smartphone. Eligible participants will be randomised to integrated CBT or usual care. Integrated CBT utilises the standard Beckian intervention for depression and comprises nine live therapist-led sessions, with (up to) a further three if clinically appropriate. The first session is 60-90 min via videocall, with subsequent 50-min sessions delivered online, using instant messaging. Participants allocated integrated CBT can access integrated online CBT resources (worksheets/information sheets/videos) within and between sessions. Outcome assessments at 3-, 6-, 9- and 12-month post-randomisation. The primary outcome is the Beck Depression Inventory (BDI-II) score at 6 months (as a continuous variable). A nested qualitative study and health economic evaluation will be conducted. DISCUSSION: If clinically and cost-effective, this model of integrated CBT could be introduced into existing psychological services, increasing access to, and equity of, CBT provision. TRIAL REGISTRATION: ISRCTN, ISRCTN13112900. Registered on 11/11/2020. Currently recruiting participants. Trial registration data are presented in Table 1.

The Concise Assessment of Leader Management Tool: Evaluation of Healthcare Provider Leadership During Real-Life Pediatric Emergencies.

INTRODUCTION: Resuscitation events in pediatric critical and emergency care are high risk, and strong leadership is an important component of an effective response. The Concise Assessment of Leadership Management (CALM) tool, designed to assess the strength of leadership skills during pediatric crises, has shown promising validity and reliability in simulated settings. The objective of this study was to generate further validity and reliability evidence for the CALM by applying it to real-life emergency events. METHODS: A prospective, video-based study was conducted in an academic pediatric emergency department. Three reviewers independently applied the CALM tool to the assessment of pediatric emergency department physicians as they led both a cardiac arrest and a sepsis event. Time to critical event (epinephrine, fluid, and antibiotic administration) was collected via video review. Based on Kane's framework, we conducted fully crossed, person × event × rater generalizability (G) and decision (D) studies. Interrater reliability was calculated using Gwet AC 2 and intraclass correlation coefficients. Time to critical events was correlated with CALM scores using Spearman coefficient. RESULTS: Nine team leaders were assessed in their leadership of 2 resuscitations each. The G coefficient was 0.68, with 26% subject variance, 20% rater variance, and no case variance. Thirty-three percent of the variance (33%) was attributed to third-order interactions and unknown factors. Gwet AC 2 was 0.3 and intraclass correlation was 0.58. The CALM score and time to epinephrine correlated at -0.79 ( P = 0.01). The CALM score and time to fluid administration correlated at -0.181 ( P = 0.64). CONCLUSIONS: This study provides additional validity evidence for the CALM tool's use in this context if used with multiple raters, aligning with data from the previous simulation-based CALM validity study. Further development may improve reliability. It also serves as an exemplar of the rigors of conducting validity work within medical simulation.

Development and Validation of a Point-of-Care-Ultrasound Image Quality Assessment Tool: The POCUS IQ Scale.

OBJECTIVES: We aimed to develop a standardized scoring tool to measure point-of-care ultrasound (POCUS) image quality and to determine validity evidence for its use to assess lung ultrasound image quality. METHODS: The POCUS Image Quality (POCUS IQ) scale was developed by POCUS-trained physicians to assess sonographers' image acquisition skills by evaluating image quality for any POCUS application. The scale was piloted using lung images of healthy standardized patients acquired by three expert sonographers compared to three novices before and after training. All images (experts, novices pre-training, novices post-training) were scored on the POCUS IQ scale by three blinded POCUS-trained physicians. Reliability was assessed with fully-crossed generalizability and decision studies. Validity was assessed using Messick's framework. RESULTS: Content validity was supported by the tool's development process of literature review, expert consensus, and pilot testing. Response process was supported by reviewer training and the blinded scoring process. Relation to other variables was supported by scores relating to sonographer experience: median expert score = 10.5/14 (IQR: 4), median novice pre-training score = 6/14 (IQR: 2.25), and novices' improvement after training (median post-training score = 12/14, IQR: 3.25). Internal structure was supported by internal consistency data (coefficient alpha = 0.84, omega coefficient = 0.91) and the generalizability study showing the main contributor to score variability was the sonographer (51%). The G-coefficient was 0.89, suggesting very good internal structure, however, Gwet's AC2  was 0.5, indicating moderate interrater reliability. The D study projected a minimum of 1 reviewer and 2 patients are needed for good psychometric reliability. CONCLUSIONS: The POCUS scale has good preliminary validity evidence as an assessment tool for lung POCUS image acquisition skills. Further studies are needed to demonstrate its utility for other POCUS applications and as a feedback tool for POCUS learners.

Core Components of a Pediatric Critical Care Transport Communication Curriculum: A Modified Delphi Approach.

OBJECTIVE: Interfacility transport of critically ill infants and children is an essential part of the care of children in the United States. However, there is tremendous variation in how transports are coordinated and performed. Pediatric critical care medicine (PCCM) fellows have differing experiences in their fellowships, and there is no standardized way of training medical command for the transport process. The aim of this study was to use a consensus-building process to establish core components of a PCCM transport curriculum focused on communication. METHODS: A national group of experts in transport medicine rated 51 total possible topics for their importance to include in a fellowship curriculum. Three rounds of surveys were completed. RESULTS: Fifty-two of 372 invitees (14%) participated in round 1. Consensus was reached to include 15 items in a PCCM curriculum. Twenty of 52 (38%) experts completed round 2, reaching consensus on 2 additional items. Seventeen of 20 (85%) experts completed round 3. No additional items reached consensus. CONCLUSION: Experts reached consensus on 17 core components to include in a PCCM fellowship transport communication curriculum. This curriculum could likely be adapted to train providers from different disciplines in the transport process.

Socioeconomic Indicators of Treatment Prognosis for Adults With Depression: A Systematic Review and Individual Patient Data Meta-analysis.

Importance: Socioeconomic factors are associated with the prevalence of depression, but their associations with prognosis are unknown. Understanding this association would aid in the clinical management of depression. Objective: To determine whether employment status, financial strain, housing status, and educational attainment inform prognosis for adults treated for depression in primary care, independent of treatment and after accounting for clinical prognostic factors. Data Sources: The Embase, International Pharmaceutical Abstracts, MEDLINE, PsycINFO, and Cochrane (CENTRAL) databases were searched from database inception to October 8, 2021. Study Selection: Inclusion criteria were as follows: randomized clinical trials that used the Revised Clinical Interview Schedule (CIS-R; the most common comprehensive screening and diagnostic measure of depressive and anxiety symptoms in primary care randomized clinical trials), measured socioeconomic factors at baseline, and sampled patients with unipolar depression who sought treatment for depression from general physicians/practitioners or who scored 12 or more points on the CIS-R. Exclusion criteria included patients with depression secondary to a personality or psychotic disorder or neurologic condition, studies of bipolar or psychotic depression, studies that included children or adolescents, and feasibility studies. Studies were independently assessed against inclusion and exclusion criteria by 2 reviewers. Data Extraction and Synthesis: Data were extracted and cleaned by data managers for each included study, further cleaned by multiple reviewers, and cross-checked by study chief investigators. Risk of bias and quality were assessed using the Quality in Prognosis Studies (QUIPS) and Grading of Recommendations, Assessment, Development and Evaluation (GRADE) tools, respectively. This study followed the Preferred Reporting Items for Systematic Reviews and Meta-analyses-Individual Participant Data (PRISMA-IPD) reporting guidelines. Main Outcomes and Measures: Depressive symptoms at 3 to 4 months after baseline. Results: This systematic review and individual patient data meta-analysis identified 9 eligible studies that provided individual patient data for 4864 patients (mean [SD] age, 42.5 (14.0) years; 3279 women [67.4%]). The 2-stage random-effects meta-analysis end point depressive symptom scale scores were 28% (95% CI, 20%-36%) higher for unemployed patients than for employed patients and 18% (95% CI, 6%-30%) lower for patients who were homeowners than for patients living with family or friends, in hostels, or homeless, which were equivalent to 4.2 points (95% CI, 3.6-6.2 points) and 2.9 points (95% CI, 1.1-4.9 points) on the Beck Depression Inventory II, respectively. Financial strain and educational attainment were associated with prognosis independent of treatment, but unlike employment and housing status, there was little evidence of associations after adjusting for clinical prognostic factors. Conclusions and Relevance: Results of this systematic review and meta-analysis revealed that unemployment was associated with a poor prognosis whereas home ownership was associated with improved prognosis. These differences were clinically important and independent of the type of treatment received. Interventions that address employment or housing difficulties could improve outcomes for patients with depression.

From Concept to Publication: Effectiveness of the International Network for Simulation-Based Pediatric Innovation, Research, and Education Project Development Process at Generating Simulation Scholarship.

BACKGROUND: As simulation matures, it is critical to develop pathways for researchers. A recent analysis, however, demonstrates a low conversion rate between abstract and peer-reviewed journal publication in our field. The International Network for Simulation-based Pediatric Innovation, Research, and Education has used the ALERT Presentation process for the past decade as a means of accelerating research. In this study, we analyze the scholarly products attributable to ALERT Presentations. METHODS: Surveys were distributed to all International Network for Simulation-based Pediatric Innovation, Research, and Education Advanced Look Exploratory Research Template (ALERT) Presentation first authors from January 2011 through January 2020. Presenters were asked to provide information on abstracts, grants, journal publications, and book chapters related to their ALERT Presentation, as well as basic demographic information. A structured literature search was conducted for those ALERT Presentations whose authors did not return a survey. The resulting database was descriptively analyzed, and statistical correlations between demographic variables and scholarship were examined. RESULTS: One hundred sixty-five new ALERT presentations were presented over 10 years. We identified 361 associated scholarly works (170 conference abstracts, 125 peer-reviewed journal publications, 65 grants, and 1 book chapter). Sixty-one percent (101 of 165) of ALERT Presentations produced at least 1 item of scholarship, and 59% (34 of 58) of ALERT Presentations that resulted in at least 1 abstract also led to at least 1 peer-reviewed journal article. Presenter gender was associated with likelihood of journal publication. CONCLUSIONS: The ALERT Presentation process is an effective approach for facilitating the development of projects that result in disseminated scholarship. Wider adoption may benefit other simulation and education research networks.

Cost-Utility Analysis of Discontinuing Antidepressants in England Primary Care Patients Compared with Long-Term Maintenance: The ANTLER Study.

BACKGROUND: Depression is a common mental health condition with considerable negative impact on health and well-being. Although antidepressants are recommended as first-line treatment, there is limited evidence regarding the cost effectiveness of long-term maintenance antidepressants for preventing relapse. OBJECTIVES: Our objective was to calculate the mean incremental costs and quality-adjusted life-years (QALYs) over 12 months of discontinuing long-term antidepressant medication in well patients compared with maintenance, using patient-level trial data. METHODS: We conducted a cost-utility analysis of 478 participants from 150 UK general practices recruited to a randomised, double-blind trial (ANTLER). QALYs were calculated from EQ-5D-5L and 12-Item Short Form survey (SF-12) results, with primary analysis using the EQ-5D-5L value set for England. Resource use was collected from primary care patient electronic medical records and self-completed questionnaires capturing mental-health-related resource use. Costs were calculated by applying standard UK unit costs to resource use. Adjustments were made for baseline variables. RESULTS: Participants randomised to discontinuation had significantly worse utility scores at 3 months (- 0.032; 95% confidence interval [CI] - 0.053 to - 0.011) but no significant difference in QALYs (- 0.011; 95% CI - 0.026 to 0.003) or costs (£3.11; 95% CI - 41.28 to 47.50) at 12 months. The probability that discontinuation was cost effective compared with maintenance was 12.9% at a threshold of £20,000 per QALY gained. CONCLUSIONS: Discontinuation of antidepressants was unlikely to be cost effective compared with maintenance for currently well patients on long-term antidepressants. However, this analysis provides no information on the wider impact of antidepressants. Our findings provide information on the potential impact of discontinuing long-term maintenance antidepressants and facilitate improving guidance for shared patient-clinician decision making. TRIAL REGISTRATION: EudraCT number 2015-004210-26; ISRCTN number ISRCTN15969819.

Antidepressant medication to prevent depression relapse in primary care: the ANTLER RCT.

BACKGROUND: There has been a steady increase in the number of primary care patients receiving long-term maintenance antidepressant treatment, despite limited evidence of a benefit of this treatment beyond 8 months. OBJECTIVE: The ANTidepressants to prevent reLapse in dEpRession (ANTLER) trial investigated the clinical effectiveness and cost-effectiveness of antidepressant medication in preventing relapse in UK primary care. DESIGN: This was a Phase IV, double-blind, pragmatic, multisite, individually randomised parallel-group controlled trial, with follow-up at 6, 12, 26, 39 and 52 weeks. Participants were randomised using minimisation on centre, type of antidepressant and baseline depressive symptom score above or below the median using Clinical Interview Schedule - Revised (two categories). Statisticians were blind to allocation for the outcome analyses. SETTING: General practices in London, Bristol, Southampton and York. PARTICIPANTS: Individuals aged 18-74 years who had experienced at least two episodes of depression and had been taking antidepressants for ≥ 9 months but felt well enough to consider stopping their medication. Those who met an International Statistical Classification of Diseases and Related Health Problems, Tenth Revision, diagnosis of depression or with other psychiatric conditions were excluded. INTERVENTION: At baseline, participants were taking citalopram 20 mg, sertraline 100 mg, fluoxetine 20 mg or mirtazapine 30 mg. They were randomised to either remain on their current medication or discontinue medication after a tapering period. MAIN OUTCOME MEASURES: The primary outcome was the time, in weeks, to the beginning of the first depressive episode after randomisation. This was measured by a retrospective Clinical Interview Schedule - Revised that assessed the onset of a depressive episode in the previous 12 weeks, and was conducted at 12, 26, 39 and 52 weeks. The depression-related resource use was collected over 12 months from medical records and patient-completed questionnaires. Quality-adjusted life-years were calculated using the EuroQol-5 Dimensions, five-level version. RESULTS: Between 9 March 2017 and 1 March 2019, we randomised 238 participants to antidepressant continuation (the maintenance group) and 240 participants to antidepressant discontinuation (the discontinuation group). The time to relapse of depression was shorter in the discontinuation group, with a hazard ratio of 2.06 (95% confidence interval 1.56 to 2.70; p < 0.0001). By 52 weeks, relapse was experienced by 39% of those who continued antidepressants and 56% of those who discontinued antidepressants. The secondary analysis revealed that people who discontinued experienced more withdrawal symptoms than those who remained on medication, with the largest difference at 12 weeks. In the discontinuation group, 37% (95% confidence interval 28% to 45%) of participants remained on their randomised medication until the end of the trial. In total, 39% (95% confidence interval 32% to 45%) of participants in the discontinuation group returned to their original antidepressant compared with 20% (95% confidence interval 15% to 25%) of participants in maintenance group. The health economic evaluation demonstrated that participants randomised to discontinuation had worse utility scores at 3 months (-0.037, 95% confidence interval -0.059 to -0.015) and fewer quality-adjusted life-years over 12 months (-0.019, 95% confidence interval -0.035 to -0.003) than those randomised to continuation. The discontinuation pathway, besides giving worse outcomes, also cost more [extra £2.71 per patient over 12 months (95% confidence interval -£36.10 to £37.07)] than the continuation pathway, although the cost difference was not significant. CONCLUSIONS: Patients who discontinue long-term maintenance antidepressants in primary care are at increased risk of relapse and withdrawal symptoms. However, a substantial proportion of patients can discontinue antidepressants without relapse. Our findings will give patients and clinicians an estimate of the likely benefits and harms of stopping long-term maintenance antidepressants and improve shared decision-making. The participants may not have been representative of all people on long-term maintenance treatment and we could study only a restricted range of antidepressants and doses. Identifying patients who will not relapse if they discontinued antidepressants would be clinically important. TRIAL REGISTRATION: Current Controlled Trials ISRCTN15969819 and EudraCT 2015-004210-26. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 69. See the NIHR Journals Library website for further project information.

Antidepressants are used to treat depression when someone is unwell, but are also used as maintenance treatment to prevent the reoccurrence of depression. There has been a large increase in the use of long-term maintenance antidepressant treatment, but the evidence for the benefits of maintenance beyond 8 months is very poor. The ANTidepressants to prevent reLapse in dEpRession (ANTLER) trial was a randomised controlled trial that examined the effectiveness of long-term maintenance treatment with antidepressants. The participants were well enough to consider stopping antidepressant medication, were recruited from primary care and had taken antidepressants for ≥ 9 months. In total, 238 participants were randomised to continue taking antidepressants and 240 were randomised to receive a visually identical tablet that contained no active ingredients after a period when the antidepressants were gradually reduced. Neither the participants nor those interviewing them knew which group they had been placed in, and they were followed up for 1 year. Participants who discontinued antidepressants were more likely to experience relapse than those who continued antidepressants. By 52 weeks, 39% of those who continued antidepressants had experienced a relapse, compared with 56% in the group that discontinued antidepressants. In other words, over a 52-week period, one in every six patients who stopped antidepressants would experience a relapse that may not have occurred if they had remained on their antidepressants. Patients in the discontinuation group reported more symptoms of anxiety and depression and experienced more withdrawal symptoms than those in the maintenance group, mostly in the first 3­4 months after stopping the antidepressants. Participants in the discontinuation group also reported lower quality of life than those in the maintenance group but both groups used similar amounts of health-care and social care resources over the 12-month period. About one-third of participants who were allocated to the discontinuation group in the ANTLER trial decided to restart their antidepressants. However, another one-third of participants in that group remained on trial medication for 12 months and managed without antidepressants. Long-term maintenance treatment with antidepressants is effective in reducing the rate of relapses. For those who are considering stopping their antidepressant, our findings will provide estimates of the likely benefits and harms, to improve shared decision-making and support the regular review of long-term antidepressant prescription.

Reporting of Unsafe Conditions at an Academic Women and Children's Hospital.

BACKGROUND: Unsafe conditions (UCs) are circumstances that increase the probability of a patient safety event occurring. Each UC identified presents an opportunity to prevent a near miss or adverse patient event through proactive mitigation. The aim of this study was to describe the frequency, characteristics, contributing factors, and potential for harm of reported UCs. METHODS: This is a retrospective descriptive analysis of UC incident reports voluntarily entered into an electronic medical event reporting system at a single tertiary care women and children's hospital. Reports were reviewed and categorized using a previously published classification scheme and a modified Healthcare Failure Mode and Effects Analysis (HFMEA). Reporter role, hospital location, and time to incident resolution were also described. RESULTS: Between July 1, 2016, and June 30, 2019, 348 UCs were entered, representing 3.4% of all reports. Predominant categories of UCs were equipment (43.7%), medication (20.7%), and environmental safety (14.4%). A contributing factor was identified for >99.4% of all UCs, with 77.6% having more than one. Nurses (70.1%) submitted the highest numbers of UCs. The majority of UCs were of mild severity (79.9%) but had the potential to recur frequently (73.3%). CONCLUSION: UCs represented a small proportion of all reported events across the hospital. Equipment and medication issues were important causes of UCs, and most UCs had one or more contributing factors. Though most UCs were of mild severity, they had a predicted potential to recur frequently, representing significant opportunities for improvement.

Psychometric Testing of the Debriefing Assessment for Simulation in Healthcare (DASH) for Trainee-led, In Situ Simulations in the Pediatric Emergency Department Context.

OBJECTIVES: Effective trainee-led debriefing after critical events in the pediatric emergency department has potential to improve patient care, but debriefing assessments for this context have not been developed. This study gathers preliminary validity and reliability evidence for the Debriefing Assessment for Simulation in Healthcare (DASH) as an assessment of trainee-led post-critical event debriefing. METHODS: Eight fellows led teams in three simulated critical events, each followed by a video-recorded discussion of performance mimicking impromptu debriefings occurring after real clinical events. Three raters assessed the recorded debriefings using the DASH, and their feedback was collated. Data were analyzed using generalizability theory, Gwet's AC2, intraclass correlation coefficient (ICC), and coefficient alpha. Validity was examined using Messick's framework. RESULTS: The DASH instrument had relatively low traditional inter-rater reliability (Gwet's AC2 = 0.24, single-rater ICC range = 0.16-0.35), with 30% fellow, 19% rater, and 23% rater by fellow variance. DASH generalizability (G) coefficient was 0.72, confirming inadequate reliability for research purposes. Decision (D) study results suggest the DASH can attain a G coefficient of 0.8 with five or more raters. Coefficient alpha was 0.95 for the DASH. A total of 90 and 40% of items from Elements 1 and 4, respectively, were deemed "not applicable" or left blank. CONCLUSIONS: Our results suggest that the DASH does not have sufficient validity and reliability to rigorously assess debriefing in the post-critical event environment but may be amenable to modification. Further development of the tool will be needed for optimal use in this context.

Cost-Effectiveness of Different Formats for Delivery of Cognitive Behavioral Therapy for Depression: A Systematic Review Based Economic Model.

OBJECTIVES: Cognitive behavioral therapy (CBT) is an effective treatment for depression. Different CBT delivery formats (face-to-face [F2F], multimedia, and hybrid) and intensities have been used to expand access to the treatment. The aim of this study is to estimate the long-term cost-effectiveness of different CBT delivery modes. METHODS: A decision-analytic model was developed to evaluate the cost-effectiveness of different CBT delivery modes and variations in intensity in comparison with treatment as usual (TAU). The model covered an average treatment period of 4 months with a 5-year follow-up period. The model was populated using a systematic review of randomized controlled trials and various sources from the literature. RESULTS: Incremental cost-effectiveness ratios of treatments compared with the next best option after excluding all the dominated and extended dominated options are: £209/quality-adjusted life year (QALY) for 6 (sessions) × 30 (minutes) F2F-CBT versus TAU; £4 453/QALY for 8 × 30 F2F versus 6 × 30 F2F; £12 216/QALY for 8 × 60 F2F versus 8 × 30 F2F; and £43 072/QALY for 16 × 60 F2F versus 8 × 60 F2F. The treatment with the highest net monetary benefit for thresholds of £20 000 to £30 000/QALY was 8 × 30 F2F-CBT. Probabilistic sensitivity analysis illustrated 6 × 30 F2F-CBT had the highest probability (32.8%) of being cost-effective at £20 000/QALY; 16 × 60 F2F-CBT had the highest probability (31.0%) at £30 000/QALY. CONCLUSIONS: All CBT delivery modes on top of TAU were found to be more cost-effective than TAU alone. Four F2F-CBT options (6 × 30, 8 × 30, 8 × 60, 16 × 60) are on the cost-effectiveness frontier. F2F-CBT with intensities of 6 × 30 and 16 × 60 had the highest probabilities of being cost-effective. The results, however, should be interpreted with caution owing to the high level of uncertainty.

Strengthening national nutrition research: rationale and options for a new coordinated federal research effort and authority.

BACKGROUND: The US faces remarkable food and nutrition challenges. A new federal effort to strengthen and coordinate nutrition research could rapidly generate the evidence base needed to address these multiple national challenges. However, the relevant characteristics of such an effort have been uncertain. OBJECTIVES: Our aim was to provide an objective, informative summary of 1) the mounting diet-related health burdens facing our nation and corresponding economic, health equity, national security, and sustainability implications; 2) the current federal nutrition research landscape and existing mechanisms for its coordination; 3) the opportunities for and potential impact of new fundamental, clinical, public health, food and agricultural, and translational scientific discoveries; and 4) the various options for further strengthening and coordinating federal nutrition research, including corresponding advantages, disadvantages, and potential executive and legislative considerations. METHODS: We reviewed government and other published documents on federal nutrition research; held various discussions with expert groups, advocacy organizations, and scientific societies; and held in-person or phone meetings with >50 federal staff in executive and legislative roles, as well as with a variety of other stakeholders in academic, industry, and nongovernment organizations. RESULTS: Stark national nutrition challenges were identified. More Americans are sick than are healthy, largely from rising diet-related illnesses. These conditions create tremendous strains on productivity, health care costs, health disparities, government budgets, US economic competitiveness, and military readiness. The coronavirus disease 2019 (COVID-19) outbreak has further laid bare these strains, including food insecurity, major diet-related comorbidities for poor outcomes from COVID-19 such as diabetes, hypertension, and obesity, and insufficient surveillance on and coordination of our food system. More than 10 federal departments and agencies currently invest in critical nutrition research, yet with relatively flat investments over several decades. Coordination also remains suboptimal, documented by multiple governmental reports over 50 years. Greater harmonization and expansion of federal investment in nutrition science, not a silo-ing or rearrangement of existing investments, has tremendous potential to generate new discoveries to improve and sustain the health of all Americans. Two identified key strategies to achieve this were as follows: 1) a new authority for robust cross-governmental coordination of nutrition research and other nutrition-related policy and 2) strengthened authority, investment, and coordination for nutrition research within the NIH. These strategies were found to be complementary, together catalyzing important new science, partnerships, coordination, and returns on investment. Additional complementary actions to accelerate federal nutrition research were identified at the USDA. CONCLUSIONS: The need and opportunities for strengthened federal nutrition research are clear, with specific identified options to help create the new leadership, strategic planning, coordination, and investment the nation requires to address the multiple nutrition-related challenges and grasp the opportunities before us.

The coMforT study of a trauma-informed mindfulness intervention for women who have experienced domestic violence and abuse: a protocol for an intervention refinement and individually randomized parallel feasibility trial.

BACKGROUND: Domestic violence and abuse (DVA) is common and destructive to health. Post-traumatic stress disorder (PTSD) is a major mental health consequence of DVA. People who have experienced DVA have specific needs, arising from the repeated and complex nature of the trauma. The National Institute for Health and Care Excellence recommends more research on the effectiveness of psychological interventions for people who have experienced DVA. There is growing evidence that mindfulness-based interventions may help trauma symptoms. METHODS: Intervention refinement and randomized controlled feasibility trial. A prototype trauma-informed mindfulness-based cognitive therapy (TI-MBCT) intervention will be co-produced following qualitative interviews and consensus exercise with stakeholders. Participants in the feasibility trial will be recruited from DVA agencies in two geographical regions and randomized to receive either TI-MBCT or usual care (self-referral to the Improving Access to Psychological Therapies (IAPT) service). TI-MBCT will be delivered as a group-based eight-week program. It will not be possible to blind the participants or the assessors to the study allocation. The following factors will inform the feasibility of progressing to a fully powered trial: recruitment, retention, intervention fidelity, and the acceptability of the intervention and trial design to participants. We will also test the feasibility of measuring the following participant outcomes before and 6 months post-randomization: PTSD, dissociative symptoms, depression, anxiety, DVA re-victimization, self-compassion, and mother-reported child health. Process evaluation and economic analysis will be embedded within the feasibility trial. DISCUSSION: This study will lead to the development of a TI-MBCT intervention for DVA survivors with PTSD and inform the feasibility and design of a fully powered randomized controlled trial (RCT). The full trial will aim to determine the effectiveness and cost-effectiveness of a TI-MBCT intervention in improving the clinically important symptoms of PTSD in DVA survivors. TRIAL REGISTRATION: ISRCTN, ISRCTN64458065, Registered 11 January 2019.

The feasibility of low-intensity psychological therapy for depression co-occurring with autism in adults: The Autism Depression Trial (ADEPT) - a pilot randomised controlled trial.

Low-intensity cognitive behaviour therapy including behavioural activation is an evidence-based treatment for depression, a condition frequently co-occurring with autism. The feasibility of adapting low-intensity cognitive behaviour therapy for depression to meet the needs of autistic adults via a randomised controlled trial was investigated. The adapted intervention (guided self-help) comprised materials for nine individual sessions with a low-intensity psychological therapist. Autistic adults (n = 70) with depression (Patient Health Questionnaire-9 score ⩾10) recruited from National Health Service adult autism services and research cohorts were randomly allocated to guided self-help or treatment as usual. Outcomes at 10-, 16- and 24-weeks post-randomisation were blind to treatment group. Rates of retention in the study differed by treatment group with more participants attending follow-up in the guided self-help group than treatment as usual. The adapted intervention was well-received, 86% (n = 30/35) of participants attended the pre-defined 'dose' of five sessions of treatment and 71% (25/35) attended all treatment sessions. The findings of this pilot randomised controlled trial indicate that low-intensity cognitive behaviour therapy informed by behavioural activation can be successfully adapted to meet the needs of autistic people. Evaluation of the effectiveness of this intervention in a full scale randomised controlled trial is now warranted.

Investigating the effectiveness and cost-effectiveness of FITNET-NHS (Fatigue In Teenagers on the interNET in the NHS) compared to activity management to treat paediatric chronic fatigue syndrome (CFS)/myalgic encephalomyelitis (ME): amendment to the published protocol.

The FITNET-NHS Trial is a UK, national, trial investigating whether an online cognitive behavioural therapy program (FITNET-NHS) for treating chronic fatigue syndrome/ME in adolescents is clinically effective and cost-effective in the NHS. At the time of writing (September 2019), the trial was recruiting participants. This article presents an update to the planned sample size and data collection duration previously published within the trial protocol. TRIAL REGISTRATION: ISRCTN, ID: 18020851. Registered 8 April 2016.