Using the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) in Supervision.

The Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) is a useful framework for supporting teacher development in the context of mindfulness-based supervision (MBS). It offers a framework that enhances clarity, develops reflexive practice, gives a structure for feedback, and supports learning. MBS is a key component of Mindfulness-Based Program (MBP) teacher training and ongoing good practice. Integrating the MBI:TAC within the MBS process adds value in a number of ways including: offering a shared language around MBP teaching skills and processes; framing the core pedagogical features of MBP teaching; enabling assessment of developmental stage; and empowering supervisees to be proactive in their own development. The paper lays out principles for integrating the MBI:TAC framework into MBS. The supervisor needs awareness of the ways in which the tool can add value, and the ways it can inadvertently interrupt learning. The tool enables skills clarification, but the learning process needs to remain open to spontaneous experiential discovery; it can enable structured feedback but space is also needed for open reflective feedback; and it can enable conceptual engagement with the teaching process but space is needed for the supervisee to experientially sense the teaching process. The tool needs to be introduced in a carefully staged way to create optimal conditions for learning at the various stages of the MBP teacher-training journey. Practical guidance is presented to consolidate and develop current practice. The principles and processes discussed can be generalized to other forms of reflective dialogue such as mentoring, tutoring and peer reflection groups.

Observational assessment of safety in seroquel (OASIS): a specialist cohort event monitoring (SCEM) study in England.

BACKGROUND: This study was designed to monitor the short-term (up to 12 weeks) use and safety of quetiapine (Seroquel) extended release (XL) and quetiapine immediate release (IR) prescribed to patients with a clinical diagnosis of schizophrenia, and/or manic episodes associated with bipolar disorder by psychiatrists under normal conditions of use. METHODS: A Specialist Cohort Event Monitoring (SCEM) study was conducted in England February 2010-April 2013. This observational cohort study recruited patients prescribed quetiapine XL within the secondary care setting by psychiatrists. A reference cohort of quetiapine IR users was also recruited. Baseline and 12 week observational data were collected from psychiatrists who abstracted information from medical records onto bespoke questionnaires. Data were collected on demographics, indication, past medical history, prescribing information and events of interest. Summary descriptive statistics were calculated. RESULTS: The final cohort consisted of 869 eligible patients; 646 XL users and 223 IR users. The majority of XL and IR users were female (56.2% and 55.6%, respectively), with a median age of 40 (interquartile range [IQR]: 29, 49) and 39 (IQR: 28, 50) years, respectively. The most frequent indication for treatment was Manic episodes associated with Bipolar Affective disorder (53.4% XL and 49.8% IR). Median index dose was 200 mg/day (IQR: 100, 300) for XL users and 50 mg/day (IQR: 50, 100) for IR users, while median final maintenance dose was 400mg/day (IQR: 250, 600) and 300 mg/day (IQR: 100, 400), respectively. The most frequently reported event of interest in both cohorts was sedation (n = 151, 23.9% XL cohort and n = 49, 23.0% IR cohort). CONCLUSION: Utilisation of quetiapine XL appeared to be in line with prescribing guidelines in terms of dose, and commonly reported events of interest were in concordance with the known safety profile. Overall, this SCEM study provided important information on the safety and utilisation of quetiapine XL in the secondary care setting in England.

Lopinavir-Ritonavir in the Treatment of COVID-19: A Dynamic Systematic Benefit-Risk Assessment.

INTRODUCTION AND OBJECTIVE: COVID-19 is an ongoing, global public health crisis for which safe and effective treatments need to be identified. The benefit-risk balance for the use of lopinavir-ritonavir in COVID-19 needs to be monitored on an ongoing basis, therefore a systematic benefit-risk assessment was designed and conducted. A key objective of this study was to provide a platform for a dynamic systematic benefit-risk evaluation; although initially this evaluation is likely to contain limited information, it is required because of the urgent unmet public need. Importantly, it allows additional data to be incorporated as they become available, and re-evaluation of the benefit-risk profile. METHODS: A systematic benefit-risk assessment was conducted using the Benefit-Risk Action Team (BRAT) framework. The exposure of interest was lopinavir-ritonavir treatment in severe COVID-19 compared to standard of care, placebo or other treatments. A literature search was conducted in PubMed and Embase to identify peer-reviewed papers reporting clinical outcomes. Two clinicians constructed a value tree and ranked key benefits and risks in order of considered clinical importance. RESULTS: We screened 143 papers from PubMed and 264 papers from Embase for lopinavir-ritonavir; seven papers were included in the final benefit-risk assessment. In comparison to standard of care, data for several key benefits and risks were identified for lopinavir-ritonavir. Time to clinical improvement was not significantly different for lopinavir-ritonavir in comparison to standard of care (hazard ratio 1.31, 95% confidence interval 0.95-1.80). From one study, there were fewer cases of acute respiratory distress syndrome with lopinavir-ritonavir compared with standard of care (13% vs 27%). There also appeared to be fewer serious adverse events with lopinavir-ritonavir (20%) vs standard of care (32%). Limited data were available for comparison of lopinavir-ritonavir to other treatments. CONCLUSIONS: Based on currently available data, there was no clear benefit for the use of lopinavir-ritonavir compared to standard of care in severe COVID-19. Risk data suggested a possible decrease in serious adverse events. There was a reduction in acute respiratory distress syndrome with lopinavir-ritonavir in one study. Overall, the benefit-risk profile for lopinavir-ritonavir in severe COVID-19 cannot be considered positive until further efficacy and effectiveness data become available.

Remdesivir in Treatment of COVID-19: A Systematic Benefit-Risk Assessment.

INTRODUCTION: There is a need to identify effective, safe treatments for COVID-19 (coronavirus disease) rapidly, given the current, ongoing pandemic. A systematic benefit-risk assessment was designed and conducted to examine the benefit-risk profile of remdesivir in COVID-19 patients compared with standard of care, placebo or other treatments. A key objective of this study was to provide a platform for a dynamic systematic benefit-risk evaluation, which starts with inevitably limited information (to meet the urgent unmet public health need worldwide), then update the benefit-risk evaluation as more data become available. METHODS: The Benefit-Risk Action Team (BRAT) framework was used to assess the overall benefit-risk of the use of remdesivir as a treatment for COVID-19 compared with standard of care, placebo or other treatments. We searched PubMed, Google Scholar and government agency websites to identify literature reporting clinical outcomes in patients taking remdesivir for COVID-19. A value tree was constructed and key benefits and risks were ranked by two clinicians in order of considered importance. RESULTS: Using the BRAT method, several key benefits and risks for use of remdesivir in COVID-19 compared with placebo have been identified. In one trial, the benefit of time to clinical improvement was not statistically significant (21 vs 23 days, HR 1.23, 95% CI 0.87-1.75), although the study was underpowered. In another trial, a shorter time to recovery in patients treated with remdesivir was observed (11 vs 15 days), with non-significant reduced mortality risk (8% vs 12%). Risk data were only available from one trial. This trial reported fewer serious adverse events in patients taking remdesivir (18%) compared with the placebo group (26%); however, more patients in the remdesivir group discontinued treatment as a result of an adverse event compared with those patients receiving placebo (12% vs 5%). CONCLUSIONS: Preliminary clinical trial results suggest that there may be a favourable benefit-risk profile for remdesivir compared with placebo in severe COVID-19 infection and further data on benefits would strengthen this evaluation. There is limited safety data for remdesivir, which should be obtained in further studies. The current framework summarises the key anticipated benefits and risks for which further data are needed. Ongoing clinical trial data can be incorporated into the framework when available to provide an updated benefit-risk assessment.

Innovations in the Plastic Surgery Care Pathway: Using Telemedicine for Clinical Efficiency and Patient Satisfaction.

BACKGROUND: Telemedicine delivers clinical information and permits discussion between providers and patients at a distance. Postoperative visits may be a burden to patients-many of whom travel long distances and miss work opportunities. By implementing a telehealth opportunity, the authors sought to develop a process that optimizes efficiency and provides optimal patient satisfaction. METHODS: Using quality improvement methods that have been highly effective in the business sector, we developed a testable workflow for patients in the postoperative telehealth setting. Seventy-two patients were enrolled and surveyed. A preoperative survey sought to determine travel distance, comfort with technology, access to the Internet and video-enabled devices, and the patient's interest in telehealth. A postoperative survey focused on patient satisfaction with the experience. RESULTS: Using the Lean Six Sigma methodology, the authors developed a telehealth workflow to optimize clinical efficiency. Preoperative surveys revealed that the majority (73 percent) of patients preferred in-person follow-up visits in the clinic. However, the postoperative survey distributed after the telehealth encounter found that nearly 100 percent of patients were satisfied with the telehealth experience. Ninety-six percent of patients said that their questions were answered, and 97 percent of patients stated that they would use telehealth again in the future. CONCLUSIONS: Telehealth encounters enable real-time clinical decision-making by providing patients and visiting nurses access to providers and decreasing patient transportation needs and wait times. Although initially hesitant to opt for a telehealth encounter in lieu of a traditional visit, the great majority of patients voiced satisfaction with the telehealth experience. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Tip of the Iceberg: Assessing the Global Socioeconomic Costs of Alzheimer's Disease and Related Dementias and Strategic Implications for Stakeholders.

While it is generally understood that Alzheimer's disease (AD) and related dementias (ADRD) is one of the costliest diseases to society, there is widespread concern that researchers and policymakers are not comprehensively capturing and describing the full scope and magnitude of the socioeconomic burden of ADRD. This review aimed to 1) catalogue the different types of AD-related socioeconomic costs described in the literature; 2) assess the challenges and gaps of existing approaches to measuring these costs; and 3) analyze and discuss the implications for stakeholders including policymakers, healthcare systems, associations, advocacy groups, clinicians, and researchers looking to improve the ability to generate reliable data that can guide evidence-based decision making. A centrally emergent theme from this review is that it is challenging to gauge the true value of policies, programs, or interventions in the ADRD arena given the long-term, progressive nature of the disease, its insidious socioeconomic impact beyond the patient and the formal healthcare system, and the complexities and current deficiencies (in measures and real-world data) in accurately calculating the full costs to society. There is therefore an urgent need for all stakeholders to establish a common understanding of the challenges in evaluating the full cost of ADRD and define approaches that allow us to measure these costs more accurately, with a view to prioritizing evidence-based solutions to mitigate this looming public health crisis.

Effectiveness and cost-effectiveness of mindfulness-based cognitive therapy compared with maintenance antidepressant treatment in the prevention of depressive relapse or recurrence (PREVENT): a randomised controlled trial.

BACKGROUND: Individuals with a history of recurrent depression have a high risk of repeated depressive relapse or recurrence. Maintenance antidepressants for at least 2 years is the current recommended treatment, but many individuals are interested in alternatives to medication. Mindfulness-based cognitive therapy (MBCT) has been shown to reduce risk of relapse or recurrence compared with usual care, but has not yet been compared with maintenance antidepressant treatment in a definitive trial. We aimed to see whether MBCT with support to taper or discontinue antidepressant treatment (MBCT-TS) was superior to maintenance antidepressants for prevention of depressive relapse or recurrence over 24 months. METHODS: In this single-blind, parallel, group randomised controlled trial (PREVENT), we recruited adult patients with three or more previous major depressive episodes and on a therapeutic dose of maintenance antidepressants, from primary care general practices in urban and rural settings in the UK. Participants were randomly assigned to either MBCT-TS or maintenance antidepressants (in a 1:1 ratio) with a computer-generated random number sequence with stratification by centre and symptomatic status. Participants were aware of treatment allocation and research assessors were masked to treatment allocation. The primary outcome was time to relapse or recurrence of depression, with patients followed up at five separate intervals during the 24-month study period. The primary analysis was based on the principle of intention to treat. The trial is registered with Current Controlled Trials, ISRCTN26666654. FINDINGS: Between March 23, 2010, and Oct 21, 2011, we assessed 2188 participants for eligibility and recruited 424 patients from 95 general practices. 212 patients were randomly assigned to MBCT-TS and 212 to maintenance antidepressants. The time to relapse or recurrence of depression did not differ between MBCT-TS and maintenance antidepressants over 24 months (hazard ratio 0·89, 95% CI 0·67-1·18; p=0·43), nor did the number of serious adverse events. Five adverse events were reported, including two deaths, in each of the MBCT-TS and maintenance antidepressants groups. No adverse events were attributable to the interventions or the trial. INTERPRETATION: We found no evidence that MBCT-TS is superior to maintenance antidepressant treatment for the prevention of depressive relapse in individuals at risk for depressive relapse or recurrence. Both treatments were associated with enduring positive outcomes in terms of relapse or recurrence, residual depressive symptoms, and quality of life. FUNDING: National Institute for Health Research (NIHR) Health Technology Assessment (HTA) programme, and NIHR Collaboration for Leadership in Applied Health Research and Care South West Peninsula.

Gateway to Care campaign: a public health initiative to reduce the burden of hepatitis B in Haimen City, China.

BACKGROUND: An estimated one million people worldwide die each year from complications of chronic hepatitis B infection (CHB), including liver cancer. A disproportionate number of infections and deaths occur in China. The incidence and mortality of liver cancer in Haimen City is among the highest in China, and in the world. A multi-year citywide campaign was aimed at eliminating hepatitis B virus (HBV) infection and significantly reducing the number of liver cancer deaths due to CHB in Haimen City, China. METHODS: Strategies included a public health information campaign targeting the 1.03 million city residents; specialized health education for leaders and providers to increase adoption of evidence-based HBV management protocols; establishment of health care infrastructure and management systems; and increased prevention and care delivery to key subpopulations (especially pregnant women). RESULTS: The project developed and deployed broad-reaching public awareness and health education tools and modules to 280,000 households and at community-based events. More than 90% of targeted healthcare providers and 80% of the community leaders/government officials attended educational seminars during the project period (1,441 health care providers; 1,883 local government officials). A centralized registration and management system for pregnant women was developed and instituted, 100% of pregnant women were enrolled (5,407 women over one year), and all infants born to HBV-infected mothers received one dose of HBIG and the first dose of HBV vaccine by 24 hours of birth. CONCLUSIONS: Lessons from the implementation phase of the project include the importance of: gaining early and ongoing support from the local government and health bureau for success in reaching the targeted populations; and having project management by a local, experienced, and trusted health expert to navigate implementation and relationships, and help develop culturally and linguistically appropriate materials.

Development and validation of the mindfulness-based interventions - teaching assessment criteria (MBI:TAC).

BACKGROUND: The assessment of intervention integrity is essential in psychotherapeutic intervention outcome research and psychotherapist training. There has been little attention given to it in mindfulness-based interventions research, training programs, and practice. AIMS: To address this, the Mindfulness-Based Interventions: Teaching Assessment Criteria (MBI:TAC) was developed. This article describes the MBI:TAC and its development and presents initial data on reliability and validity. METHOD: Sixteen assessors from three centers evaluated teaching integrity of 43 teachers using the MBI:TAC. RESULTS: Internal consistency (α = .94) and interrater reliability (overall intraclass correlation coefficient = .81; range = .60-.81) were high. Face and content validity were established through the MBI:TAC development process. Data on construct validity were acceptable. CONCLUSIONS: Initial data indicate that the MBI:TAC is a reliable and valid tool. It can be used in Mindfulness-Based Stress Reduction/Mindfulness-Based Cognitive Therapy outcome evaluation research, training and pragmatic practice settings, and in research to assess the impact of teaching integrity on participant outcome.

Retail food safety risks for populations of different races, ethnicities, and income levels.

Research has found that populations with low socioeconomic status (SES) and minority populations have greater access to small corner markets and less access to supermarkets than high-SES and Caucasian populations. This represents a significant difference in the farm-to-fork continuum that these populations experience. This research examined whether differential retail access to foods results in different food safety risks at the retail level for consumers with different demographics. U.S. Census Bureau census tracts with high African American, Asian, Hispanic, Caucasian, low-SES, and high-SES populations were identified in Philadelphia, PA. Approximately 60 retail food establishments were sampled in each census tract category from June 2008 to June 2010. Food samples collected at stores included milk, eggs, lunchmeat, sandwiches, and ready-to-eat (RTE) fresh fruit, greens, and herbs, when available. With the exception of milk and eggs, only food that had been handled and/or prepared at the retail level was sampled. Food samples were tested for temperature, aerobic plate count, coliforms, fecal coliforms, Escherichia coli, Staphylococcus aureus, and Listeria monocytogenes. The results indicated that internal egg temperatures were higher in samples from low-SES census tracts than in eggs from Caucasian census tracts, and eggs were more often found unrefrigerated in markets in low-SES and Asian census tracts. Milk samples from markets in Hispanic and low-SES census tracts had higher aerobic plate counts than high-SES census tract samples. Sandwiches from markets in high-SES census tracts had higher coliform counts than sandwiches from markets in all other census tract categories. Markets in Asian census tracts had a higher incidence of fecal coliform contamination on sandwiches than markets in Caucasian census tracts. Fecal coliforms were present in a percentage of RTE greens from markets in all census tracts except African American, with the highest percentages of RTE greens positive for fecal coliforms in low-SES (100%), Asian (71.4%), and Caucasian (45.5%) markets.

Antidepressants for the treatment of depression in palliative care: systematic review and meta-analysis.

Depression can exacerbate symptoms associated with life-threatening illness and increase disability and distress. In palliative care, depression occurs in a context of multiple symptoms, which complicates detection and treatment. While systematic reviews of antidepressants have been conducted in specific life-threatening diseases, no previous study has synthesized the evidence in palliative care. The objective of this study was to determine the efficacy of antidepressants for the treatment of depression in palliative care. MEDLINE, EMBASE, PSYCINFO and Cochrane trials registers were systematically searched to identify randomized controlled trials comparing antidepressants and placebo for the treatment of depression in palliative care. The primary outcome was efficacy assessed at three time-points. Twenty-five studies were included in the review. At each time-point antidepressants were more efficacious than placebo: 4-5 weeks odds ratio (OR) 1.93 (1.15-3.42) p = 0.001; 6-8 weeks OR 2.25 (1.38-3.67) p = 0.001; 9-18 weeks OR 2.71 (1.50-4.91) p = 0.001. This review provides evidence that antidepressants are effective in treating depression in palliative care. Their superiority over placebo is apparent within 4-5 weeks and increases with continued use. It is probable that the effect sizes yielded in this review overestimate the efficacy of antidepressants due to biases such as selective reporting and publication. Nevertheless, the magnitude and consistency of the effect suggests genuine benefit.

Study protocol for a randomized controlled trial comparing mindfulness-based cognitive therapy with maintenance anti-depressant treatment in the prevention of depressive relapse/recurrence: the PREVENT trial.

BACKGROUND: Depression is a common and distressing mental health problem that is responsible for significant individual disability and cost to society. Medication and psychological therapies are effective for treating depression and maintenance anti-depressants (m-ADM) can prevent relapse. However, individuals with depression often express a wish for psychological help that can help them recover from depression in the long-term. We need to develop psychological therapies that prevent depressive relapse/recurrence. A recently developed treatment, Mindfulness-based Cognitive Therapy (MBCT, see http://www.mbct.co.uk) shows potential as a brief group programme for people with recurring depression. In two studies it has been shown to halve the rates of depression recurring compared to usual care.This trial asks the policy research question, is MBCT superior to m-ADM in terms of: a primary outcome of preventing depressive relapse/recurrence over 24 months; and, secondary outcomes of (a) depression free days, (b) residual depressive symptoms, (c) antidepressant (ADM) usage, (d) psychiatric and medical co-morbidity, (e) quality of life, and (f) cost effectiveness? An explanatory research question asks is an increase in mindfulness skills the key mechanism of change? METHODS/DESIGN: The design is a single blind, parallel RCT examining MBCT vs. m-ADM with an embedded process study. To answer the main policy research question the proposed trial compares MBCT plus ADM-tapering with m-ADM for patients with recurrent depression. Four hundred and twenty patients with recurrent major depressive disorder in full or partial remission will be recruited through primary care. Depressive relapse/recurrence over two years is the primary outcome variable. The explanatory question will be addressed in two mutually informative ways: quantitative measurement of potential mediating variables pre/post-treatment and a qualitative study of service users' views and experiences. DISCUSSION: If the results of our exploratory trial are extended to this definitive trial, MBCT will be established as an alternative approach to maintenance anti-depressants for people with a history of recurrent depression. The process studies will provide evidence about the effective components which can be used to improve MBCT and inform theory as well as other therapeutic approaches. TRIAL REGISTRATION NUMBER: ISRCTN26666654.

The effectiveness of self-assessment on the identification of learner needs, learner activity, and impact on clinical practice: BEME Guide no. 10.

BACKGROUND: Health professionals are increasingly expected to identify their own learning needs through a process of ongoing self-assessment. Self-assessment is integral to many appraisal systems and has been espoused as an important aspect of personal professional behaviour by several regulatory bodies and those developing learning outcomes for clinical students. In this review we considered the evidence base on self-assessment since Gordon's comprehensive review in 1991. The overall aim of the present review was to determine whether specific methods of self-assessment lead to change in learning behaviour or clinical practice. Specific objectives sought evidence for effectiveness of self-assessment interventions to: a. improve perception of learning needs; b. promote change in learning activity; c. improve clinical practice; d. improve patient outcomes. METHODS: The methods for this review were developed and refined in a series of workshops with input from an expert BEME systematic reviewer, and followed BEME guidance. Databases searched included Medline, CINAHL, BNI, Embase, EBM Collection, Psychlit, HMIC, ERIC, BEI, TIMElit and RDRB. Papers addressing self-assessment in all professions in clinical practice were included, covering under- and post-graduate education, with outcomes classified using an extended version of Kirkpatrick's hierarchy. In addition we included outcome measures of accuracy of self-assessment and factors influencing it. 5,798 papers were retrieved, 194 abstracts were identified as potentially relevant and 103 papers coded independently by pairs using an electronic coding sheet adapted from the standard BEME form. This total included 12 papers identified by hand-searches, grey literature, cited references and updating. The identification of a further 12 papers during the writing-up process resulted in a total of 77 papers for final analysis. RESULTS: Although a large number of papers resulted from our original search only a small proportion of these were of sufficient academic rigour to be included in our review. The majority of these focused on judging the accuracy of self-assessment against some external standard, which raises questions about assumed reliability and validity of this 'gold standard'. No papers were found which satisfied Kirkpatrick's hierarchy above level 2, or which looked at the association between self-assessment and resulting changes in either clinical practice or patient outcomes. Thus our review was largely unable to answer the specific research questions and provide a solid evidence base for effective self-assessment. Despite this, there was some evidence that the accuracy of self-assessment can be enhanced by feedback, particularly video and verbal, and by providing explicit assessment criteria and benchmarking guidance. There was also some evidence that the least competent are also the least able to self-assess accurately. Our review recommends that these areas merit future systematic research to further our understanding of self-assessment. CONCLUSION: As in other BEME reviews, the methodological issues emerging from this review indicate a need for more rigorous study designs. In addition, it highlights the need to consider the potential for combining qualitative and quantitative data to further our understanding of how self-assessment can improve learning and professional clinical practice.