Widening participation - recruitment methods in mental health randomised controlled trials: a qualitative study.

BACKGROUND: Barriers to mental health research participation are well documented including distrust of services and research; and stigma surrounding mental health. They can contribute to a lack of diversity amongst participants in mental health research, which threatens the generalisability of knowledge. Given the recent widespread use of the internet in medical research, this study aimed to explore the perspectives of key partners on the use of online (e.g. social media) and offline (e.g. in-person) recruitment as an approach to improving diversity in mental health randomised controlled trials (RCTs). METHODS: Face-to-face and online interviews/focus groups with researchers working in mental health and Patient and Public Involvement partners in the United Kingdom. Recordings were transcribed and analysed using a combination of inductive and deductive thematic analysis. RESULTS: Three focus groups and three interviews were conducted with a total N = 23 participants. Four overarching themes were identified: (1) recruitment reach; (2) Demographic factors that affect selection of recruitment method; (3) safety of technology, and; (4) practical challenges. Five main factors were identified that affect the choice of recruitment method: age, complexity of mental health problem and stigma, cultural and ethnicity differences and digital divide. The use of online methods was considered more accessible to people who may feel stigmatised by their mental health condition and with a benefit of reaching a wider population. However, a common view amongst participants was that online methods require closer data monitoring for quality of responders, are not fully secure and less trustworthy compared to offline methods that enable participants to build relationships with health providers. Funding, staff time and experience, organisational support, and technical issues such as spam or phishing emails were highlighted as practical challenges facing online recruitment. All participants agreed that using a hybrid approach tailored to the population under study is paramount. CONCLUSIONS: This study highlighted the importance of offering a flexible and multifaceted recruitment approach by integrating online with offline methods to support inclusivity and widening participation in mental health research. The findings will be used to develop considerations for researchers designing RCTs to improve recruitment in mental health research.

Opportunities and challenges of delivering digital clinical trials: lessons learned from a randomised controlled trial of an online behavioural intervention for children and young people.

BACKGROUND: Despite being the gold standard of research to determine effectiveness, randomised controlled trials (RCTs) often struggle with participant recruitment, engagement and retention. These issues may be exacerbated when recruiting vulnerable populations, such as participants with mental health issues. We aimed to update understanding of the scope of these problems in trials of health technology and identify possible solutions through reflecting on experiences from an exemplar trial (Online Remote Behavioural Intervention for Tics; ORBIT). METHOD: We extracted anonymised data on recruitment, retention and requests for more funding and time from trials funded by the largest funder of health technology trials in the UK (the National Institute of Health Research Health Technology Assessment) between 2010 and 2020, and compared these with data from a recent, successful trial (ORBIT). ORBIT aimed to assess the clinical- and cost-effectiveness of blended online and human behavioural therapy for tics in young people. Many of the trial procedures, including recruitment, the intervention and data collection, were undertaken online. RESULTS: Data were extracted on 51 trials conducted between 2010 and 2020. Sixty per cent of trials failed to reach their original recruitment target and only 44% achieved their follow-up in the specified time frame. In contrast, ORBIT recruited to target and achieved 90% follow-up. We posit that these achievements are related to (a) judicious use of digital technology for trial procedures and (b) adequate numbers of highly trained and motivated trial staff. We provide details of both these to help other research teams plan and cost for successful trials. CONCLUSION: An approach combining human and online methods may be advantageous in facilitating trial delivery, particularly in paediatric mental health services. Given the importance of successful clinical trials in advancing healthcare delivery and the waste of human and economic resources associated with unsuccessfully delivered trials, it is imperative that trials are appropriately costed and future research focusses on improving trial design and delivery. TRIAL REGISTRATION: The ORBIT trial is registered with ISRTCN ( ISRCTN70758207 ) Registered on March 20, 2018. and ClinicalTrials.gov ( NCT03483493 ). Registered on March 30, 2018.

Hyperbaric oxygen therapy for mild traumatic brain injury persistent postconcussion syndrome: a randomized controlled trial.

Persistent postconcussion syndrome (PPCS) after mild traumatic brain injury (mTBI) is a significant public health and military problem for which there is limited treatment evidence. The aim of this study was to determine whether forty 150 kPa hyperbaric oxygen therapies (HBOTs) can improve symptoms and cognitive function in subjects with the PPCS of mTBI, using a randomized controlled crossover design with 2-month follow-up. Sixty-three civilian and military subjects with mTBI/PPCS were randomized to either 40 HBOTs at 150 kPa/60 minutes, once daily, 5 days per week in 8 weeks or an equivalent no-treatment control period. The Control Group was then crossed over to HBOT. Subjects underwent symptom, neuropsychological, and psychological testing, before and after treatment or control with retesting 2 months after the 40th HBOT. Fifty subjects completed the protocol with primary outcome testing. HBOT subjects experienced significant improvements in Neurobehavioral Symptom Inventory, Memory Index, Automated Neuropsychological Assessment Metrics, Hamilton Depression Scale, Hamilton Anxiety Scale, Post-Traumatic Stress Disorder Checklist, Pittsburgh Sleep Quality Index, and Quality Of Life after Brain Injury compared to the Control Group. After crossing over to HBOT the Control Group experienced near-identical significant improvements. Further improvements were experienced by both groups during the 2-month follow-up period. These data indicate that 40 HBOTs at 150 kPa/60 minutes demonstrated statistically significant improvements in postconcussion and Post-Traumatic Stress Disorder symptoms, memory, cognitive functions, depression, anxiety, sleep, and quality of life in civilian and military subjects with mTBI/PPCS compared to controls. Improvements persisted at least 2 months after the 40th HBOT. The study was registered on ClinicalTrials.gov (NCT02089594) on March 18, 2014 and with the U.S. Food and Drug Administration under Investigational New Drug #113823. The Institutional Review Boards of the United States Army Medical Research and Materiel Command Office of Research Protections Human Research Protection Office and the Louisiana State University School of Medicine (approval No. 7381) approved the study on May 13, 2014 and December 20, 2013, respectively.

The Effect of Gender on Team-Based Learning Peer Assessment in a Psychiatry Clerkship.

In team-based learning (TBL), peer evaluation is important, but also open to bias. We examined the relation between gender and summative peer feedback over 3 years in all 90 teams created in our psychiatry clerkship. Gender-equivalent (92.7 vs 88.1, p < 0.05) and majority-women (93.6 vs 88.1, p < 0.05) teams scored higher than majority-men in the first 2 years, as did women-majority teams in the third (98.3 vs 94.8, p < 0.05). Mean scores were little-affected by team size. These findings suggest TBL team gender balance can adversely affect peer evaluations. Instructors should consider team gender composition and the weight given to feedback scores.

High-Stakes Collaborative Testing: Why Not?

Phenomenon: Studies of high-stakes collaborative testing remain sparse, especially in medical education. We explored high-stakes collaborative testing in medical education, looking specifically at the experiences of students in established and newly formed teams. APPROACH: Third-year psychiatry students at 5 medical schools across 6 sites participated, with 4 participating as established team sites and 2 as comparison team sites. For the collaborative test, we used the National Board of Medical Examiners Psychiatry subject test, administering it via a 2-stage process. Students at all sites were randomly selected to participate in a focus group, with 8-10 students per site (N = 49). We also examined quantitative data for additional triangulation. FINDINGS: Students described a range of heightened emotions around the collaborative test yet perceived it as valuable regardless if they were in established or newly formed teams. Students described learning about the subject matter, themselves, others, and interpersonal dynamics during collaborative testing. Triangulation of these results via quantitative data supported these themes. Insights: Despite student concerns, high-stakes collaborative tests may be both valuable and feasible. The data suggest that high-stakes tests (tests of learning or summative evaluation) could also become tests for learning or formative evaluation. The paucity of research into this methodology in medical education suggests more research is needed.

Team cohesiveness, team size and team performance in team-based learning teams.

OBJECTIVES: The purpose of this study was to explore the relationships among variables associated with teams in team-based learning (TBL) settings and team outcomes. METHODS: We administered the National Board of Medical Examiners (NBME) Psychiatry Subject Test first to individuals and then to teams of Year three students at four medical schools that used TBL in their psychiatry core clerkships. Team cohesion was analysed using the Team Performance Scale (TPS). Bivariate correlation and linear regression analysis were used to analyse the relationships among team-level variables (mean individual TPS scores for each team, mean individual NBME scores of teams, team size, rotation and gender make-up) and team NBME test scores. A hierarchical linear model was used to test the effects of individual TPS and individual NBME test scores within each team, as well as the effects of the team-level variables of team size, team rotation and gender on team NBME test scores. Individual NBME test and TPS scores were nested within teams and treated as subsampling units. RESULTS: Individual NBME test scores and individual TPS scores were positively and statistically significantly (p < 0.01) associated with team NBME test scores, when team rotation, team size and gender make-up were controlled for. Higher team NBME test scores were associated with teams rotating later in the year and larger teams (p < 0.01). Gender make-up was not significantly associated. CONCLUSIONS: The results of an NBME Psychiatry Subject Test administered to TBL teams at four medical schools suggest that larger teams on later rotations score higher on a team NBME test. Individual NBME test scores and team cohesion were positively and significantly associated with team NBME test scores. These results suggest the need for additional studies focusing on team outcomes, team cohesion, team size, rotation and other factors as they relate to the effective and efficient performance of TBL teams in health science education.

Team Emotional Intelligence, Team Interactions, and Gender in Medical Students During a Psychiatry Clerkship.

OBJECTIVE: This study examined the relationship between team emotional intelligence, quality of team interactions, and gender. METHODS: Psychiatry clerkship students participating in Team-Based Learning (TBL, n = 484) or no TBL (control, n = 265) completed the Workgroup Emotional Intelligence Profile (WEIP-S) and the Team Performance Scale (TPS). RESULTS: Significant correlations (p < 0.01) existed between quality of team interactions (i.e., TPS) and team emotional intelligence (i.e., WEIP-S) subscales, but not gender. Control and TBL groups experienced significant increases in WEIP-S subscales pre to post (p < 0.01, η (2) = .08), with the TBL group experiencing significantly higher gains in three of four subscales. Control group scored higher on TPS. CONCLUSIONS: A significant relationship exists between team emotional intelligence and quality of team interactions. Gender was unrelated to TPS or WEIP-S subscales. TBL group experienced higher gains in WEIP-S subscales while the control group experienced slightly higher TPS scores. Results suggest implications for medical educators who use TBL.

Congenital communication of a retroaortic innominate vein with both the left and right atria in the presence of a normal coronary sinus.

We report the first known case of a retro-aortic innominate vein providing continuity between both the left and right atria in the presence of a left superior vena cava and a normal coronary sinus. This unusual structure created a bidirectional shunt with clinical desaturation at baseline and it complicated the management of a 9-year-old patient while undergoing mechanical ventilation. An embryologic mechanism that explains the development of this complex remains elusive.

Blood pressure, heart rate, and anxiety in schizophrenia.

Anxiety may worsen outcome in psychotic disorders. We assessed anxiety in 44 acutely psychotic subjects and found a positive association with heart rate and blood pressure. Risperidone treatment reduced anxiety but increased heart rate. We concluded that anxiety may adversely affect cardiovascular status in schizophrenia, but the anxiolytic effect of risperidone is not straightforward.

The therapeutic potential of escitalopram in the treatment of panic disorder.

Panic disorder is a chronic and disabling condition that is often accompanied by other psychiatric and medical conditions. The serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) have been used effectively with panic disorder (PD) and conditions in which panic attacks frequently occur. Escitalopram is the most selective SSRI and a variety of evidence suggests it is of great value in the treatment of panic disorder. In this paper, we review the theoretical and practical implications of its use.

Bipolar II disorder: current and future treatment options.

BACKGROUND: Bipolar II (BPII) disorder is a significant public health problem in the United States, and there is a dearth of studies of effective treatment modalities to deal with the recurrent major depressive episodes that accompany the disorder. This review attempts to summarize available data on agents useful in treating patients with the disease. METHODS: English language controlled clinical trials involving BPII patients obtained from an extensive Medline search were critically reviewed. RESULTS: Agents that have potential utility in the treatment of BPII are profiled, based on their efficacy in bipolar I (BPI) or unipolar depression. CONCLUSIONS: The most efficacious agents are likely those with bimodal stabilizing properties, such as lithium, carbamazepine, and quetiapine. In fact, on the strength of favorable efficacy data obtained in patients with major depressive symptoms accompanying bipolar disorder, quetiapine recently became the first agent to be indicated by the FDA for monotherapeutic use in the treatment of bipolar depression, including BPII depression. Aside from the aforementioned agents, lamotrigine also shows promise in the treatment of BPII.

Interventional occlusion of a thrombosed aortic conduit.

We report the first known closure of an aortic conduit with the Amplatzer plug device. The device was used in the case of a 20-year-old male who presented with an aortic conduit that had thrombosed and had formed a pseudo-aneurysm. A 14-mm plug and a 16-mm plug were used to close off the proximal portion of the conduit in preparation for surgery. The successful use of the device minimized the risk and the extent of the subsequent surgery.

Comorbid anxiety disorders and divalproex sodium use among partial hospital patients with psychotic disorders.

We conducted this study to determine anxiety disorder comorbidity and divalproex sodium use among 26 patients with psychotic disorders after their referral to a partial hospital. Each subject was diagnosed by structured interview, and 4 Brief Psychiatric Rating Scale (BPRS) items associated with agitation were assessed: anxiety, hostility, excitement, and tension. Subjects' medical records were then examined to determine discharge diagnoses from referring inpatient facilities as well as current medication use. Although we diagnosed many anxiety disorders, none was identified during hospitalization. Divalproex use was not associated with anxiety disorder frequency. Divalproex patients had significantly lower BPRS anxiety, tension, and excitement scores, as well as total BPRS agitation scores (P < .05). Our findings suggest that anxiety disorders are unrecognized among psychotic patients and that treatment guidelines for concurrent anxiety are needed.

Identification and assembly of V genes as idiotype-specific DNA fusion vaccines in multiple myeloma.

Tumor-specific markers are important in identifying and tracking malignant cells. In this regard, functionally rearranged immunoglobulin variable (V) region genes in B-cell tumors fulfill and extend these criteria. V genes provide signature motifs in tumor cells and can delineate critical features of the clonal history of the cell of origin. They also define a tumor-specific antigen, which can be targeted for immunotherapy. Our focus has been on using novel DNA fusion vaccines to induce antitumor immunity. Here, we describe in detail the methods for identifying tumor-derived V genes at the nucleotide level in the malignant plasma cells of multiple myeloma. We further present the methodology for assembly of tumor V genes as single-chain variable region fragments (scFv), fused in frame with an immunopotentiating nontoxic bacterial sequence, Fragment C (FrC) of tetanus toxin. These scFv.FrC DNA vaccines provide protection in myeloma models and are currently in clinical trials. The vaccines are patient specific and can be rapidly assembled for clinical use.