Augmenting Safety Planning With Text Messaging Support for Adolescents at Elevated Suicide Risk: Development and Acceptability Study

Background Suicide is the second leading cause of death among adolescents. A critical need exists for developing promising interventions for adolescents after psychiatric hospitalization who are at a high risk of experiencing repeated suicidal behaviors and related crises. The high-risk period following psychiatric hospitalization calls for cost-effective and scalable continuity of care approaches to support adolescents’ transition from inpatient care. Text messages have been used to improve a wide range of behavioral and health outcomes and may hold promise as an accessible continuity of care strategy for youth at risk of suicide. Objective In this study of 40 adolescents at elevated suicide risk, we report on the iterative development and acceptability of a text-based intervention designed to encourage adaptive coping and safety plan adherence in the high-risk period following psychiatric hospitalization. Methods Adolescents (aged 13-17 years) who were hospitalized because of last-month suicide attempts or last-week suicidal ideation took part in either study phase 1 (n=25; 19/25, 76% female), wherein message content was developed and revised on the basis of feedback obtained during hospitalization, or study phase 2 (n=15; 11/15, 73% female), wherein text messages informed by phase 1 were further tested and refined based on feedback obtained daily over the course of a month after discharge (n=256 observations) and during an end-of-study phone interview. Results Quantitative and qualitative feedback across the 2 study phases pointed to the acceptability of text-based support. Messages were seen as having the potential to be helpful with the transition after hospitalization, with adolescents indicating that texts may serve as reminders to use coping strategies, contribute to improvement in mood, and provide them with a sense of encouragement and hope. At the same time, some adolescents expressed concerns that messages may be insufficient for all teens or circumstances. In phase 2, the passage of time did not influence adolescents’ perception of messages in the month after discharge (P=.74); however, there were notable daily level associations between the perception of messages and adolescents’ affect. Specifically, higher within-person (relative to adolescents’ own average) anger was negatively related to liking text messages (P=.005), whereas within-person positive affect was associated with the perception of messages as more helpful (P=.04). Conclusions Text-based support appears to be an acceptable continuity of care strategy to support adolescents’ transition after hospitalization. The implications of study findings are discussed. Future work is needed to evaluate the impact of text-based interventions on suicide-related outcomes.

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Augmenting Safety Planning With Text Messaging Support for Adolescents at Elevated Suicide Risk: Development and Acceptability Study (Preprint)

10.2196/preprints.17345 ◽

2019 ◽

Author(s):

Ewa K Czyz ◽

Alejandra Arango ◽

Nathaniel Healy ◽

Cheryl A King ◽

Maureen Walton

Keyword(s):

High Risk ◽

Continuity Of Care ◽

Suicide Risk ◽

Psychiatric Hospitalization ◽

Phase 1 ◽

Text Messages ◽

Study Phase ◽

Phase 2 ◽

Risk Period ◽

The Impact

BACKGROUND Suicide is the second leading cause of death among adolescents. A critical need exists for developing promising interventions for adolescents after psychiatric hospitalization who are at a high risk of experiencing repeated suicidal behaviors and related crises. The high-risk period following psychiatric hospitalization calls for cost-effective and scalable continuity of care approaches to support adolescents’ transition from inpatient care. Text messages have been used to improve a wide range of behavioral and health outcomes and may hold promise as an accessible continuity of care strategy for youth at risk of suicide. OBJECTIVE In this study of 40 adolescents at elevated suicide risk, we report on the iterative development and acceptability of a text-based intervention designed to encourage adaptive coping and safety plan adherence in the high-risk period following psychiatric hospitalization. METHODS Adolescents (aged 13-17 years) who were hospitalized because of last-month suicide attempts or last-week suicidal ideation took part in either study phase 1 (n=25; 19/25, 76% female), wherein message content was developed and revised on the basis of feedback obtained during hospitalization, or study phase 2 (n=15; 11/15, 73% female), wherein text messages informed by phase 1 were further tested and refined based on feedback obtained daily over the course of a month after discharge (n=256 observations) and during an end-of-study phone interview. RESULTS Quantitative and qualitative feedback across the 2 study phases pointed to the acceptability of text-based support. Messages were seen as having the potential to be helpful with the transition after hospitalization, with adolescents indicating that texts may serve as reminders to use coping strategies, contribute to improvement in mood, and provide them with a sense of encouragement and hope. At the same time, some adolescents expressed concerns that messages may be insufficient for all teens or circumstances. In phase 2, the passage of time did not influence adolescents’ perception of messages in the month after discharge (P=.74); however, there were notable daily level associations between the perception of messages and adolescents’ affect. Specifically, higher within-person (relative to adolescents’ own average) anger was negatively related to liking text messages (P=.005), whereas within-person positive affect was associated with the perception of messages as more helpful (P=.04). CONCLUSIONS Text-based support appears to be an acceptable continuity of care strategy to support adolescents’ transition after hospitalization. The implications of study findings are discussed. Future work is needed to evaluate the impact of text-based interventions on suicide-related outcomes.

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Differential impact of on-site or telepharmacy in the intensive care unit: a controlled before–after study

International Journal for Quality in Health Care ◽

10.1093/intqhc/mzab011 ◽

2021 ◽

Vol 33 (1) ◽

Author(s):

Joao Gabriel Rosa Ramos ◽

Sandra Cristina Hernandes ◽

Talita Teles Teixeira Pereira ◽

Shana Oliveira ◽

Denis de Melo Soares ◽

...

Keyword(s):

Intensive Care Unit ◽

Intensive Care ◽

Phase 1 ◽

Phase 2 ◽

Differential Impact ◽

Scarce Resources ◽

Clinical Pharmacists ◽

Versus Phase ◽

Quasi Experimental ◽

The Impact

Abstract Background Clinical pharmacists have an important role in the intensive care unit (ICU) team but are scarce resources. Our aim was to evaluate the impact of on-site pharmacists on medical prescriptions in the ICU. Methods This is a retrospective, quasi-experimental, controlled before-after study in two ICUs. Interventions by pharmacists were evaluated in phase 1 (February to November 2016) and phase 2 (February to May 2017) in ICU A (intervention) and ICU B (control). In phase 1, both ICUs had a telepharmacy service in which medical prescriptions were evaluated and interventions were made remotely. In phase 2, an on-site pharmacist was implemented in ICU A, but not in ICU B. We compared the number of interventions that were accepted in phase 1 versus phase 2. Results During the study period, 8797/9603 (91.6%) prescriptions were evaluated, and 935 (10.6%) needed intervention. In phase 2, there was an increase in the proportion of interventions that were accepted by the physician in comparison to phase 1 (93.9% versus 76.8%, P < 0.001) in ICU A, but there was no change in ICU B (75.2% versus 73.9%, P = 0.845). Conclusion An on-site pharmacist in the ICU was associated with an increase in the proportion of interventions that were accepted by physicians.

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Emergency Stroke Calls: Obtaining Rapid Telephone Triage (ESCORTT) – a programme of research to facilitate recognition of stroke by emergency medical dispatchers

Programme Grants for Applied Research ◽

10.3310/pgfar02010 ◽

2014 ◽

Vol 2 (1) ◽

pp. 1-124 ◽

Cited By ~ 1

Author(s):

Caroline L Watkins ◽

Stephanie P Jones ◽

Michael J Leathley ◽

Gary A Ford ◽

Tom Quinn ◽

...

Keyword(s):

Phase 1 ◽

Research Programme ◽

Online Training ◽

Final Diagnosis ◽

Phase 2 ◽

The Public ◽

Training Package ◽

Emergency Medical ◽

Emergency Medical Dispatchers ◽

The Impact

BackgroundRapid access to emergency stroke care can reduce death and disability by enabling immediate provision of interventions such as thrombolysis, physiological monitoring and stabilisation. One of the ways that access to services can be facilitated is through emergency medical service (EMS) dispatchers. The sensitivity of EMS dispatchers for identifying stroke is < 50%. Studies have shown that activation of the EMSs is the single most important factor in the rapid triage and treatment of acute stroke patients.ObjectivesTo facilitate recognition of stroke by emergency medical dispatchers (EMDs).DesignAn eight-phase mixed-methods study. Phase 1: a retrospective cohort study exploring stroke diagnosis. Phase 2: semi-structured interviews exploring public and EMS interactions. Phases 3 and 4: a content analysis of 999 calls exploring the interaction between the public and EMDs. Phases 5–7: development and implementation of stroke-specific online training (based on phases 1–4). Phase 8: an interrupted time series exploring the impact of the online training.SettingOne ambulance service and four hospitals.ParticipantsPatients arriving at hospital by ambulance with stroke suspected somewhere on the stroke pathway (phases 1 and 8). Patients arriving at hospital by ambulance with a final diagnosis of stroke (phase 2). Calls to the EMSs relating to phase 1 patients (phases 3 and 4). EMDs (phase 7).InterventionsStroke-specific online training package, designed to improve recognition of stroke for EMDs.Main outcome measuresPhase 1: symptoms indicative of a final and dispatch diagnosis of stroke. Phase 2: factors involved in the decision to call the EMSs when stroke is suspected. Phases 3 and 4: keywords used by the public when describing stroke and non-stroke symptoms to EMDs. Phase 8: proportion of patients with a final diagnosis of stroke correctly dispatched as stroke by EMDs.ResultsPhase 1: for patients with a final diagnosis of stroke, facial weakness and speech problems were significantly associated with an EMD code of stroke. Phase 2: four factors were identified – perceived seriousness; seeking and receiving lay or professional advice; caller’s description of symptoms and emotional response to symptoms. Phases 3 and 4: mention of ‘stroke’ or one or more Face Arm Speech Test (FAST) items is much more common in stroke compared with non-stroke calls. Consciousness level was often difficult for callers to determine and/or communicate. Phase 8: there was a significant difference (p = 0.003) in proportions correctly dispatched as stroke – before the training was implemented 58 out of 92 (63%); during implementation of training 42 out of 48 (88%); and after training implemented 47 out of 59 (80%).ConclusionsEMDs should be aware that callers are likely to describe loss of function (e.g. unable to grip) rather than symptoms (e.g. weakness) and that callers using the word ‘stroke’ or describing facial weakness, limb weakness or speech problems are likely to be calling about a stroke. Ambiguities and contradictions in dialogue about consciousness level arise during ambulance calls for suspected and confirmed stroke. The online training package improved recognition of stroke by EMDs. Recommendations for future research include testing the effectiveness of the Emergency Stroke Calls: Obtaining Rapid Telephone Triage (ESCORTT) training package on the recognition of stroke across other EMSs in England; and exploring the impact of the early identification of stroke by call handlers on patient and process outcomes.FundingThe National Institute for Health Research Programme Grants for Applied Research programme.

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Enhancing pronunciation teaching in the tertiary EFL classrooom: A Vietnamese case study

10.26686/wgtn.17143844.v1 ◽

2021 ◽

Author(s):

◽

Loc Tan Nguyen

Keyword(s):

Professional Learning ◽

Teaching Practices ◽

Phase 1 ◽

Lesson Plans ◽

Instructional Materials ◽

Classroom Observations ◽

Study Phase ◽

Phase 2 ◽

Initial Training ◽

Teachers And Students

Recent years have seen increasing research interest in the teaching of pronunciation in English as a second/foreign language classes (Thomson & Derwing, 2014), with particular strands of this research focused on understanding how pronunciation is represented in instructional materials and actual teaching practices in a range of settings and in teacher cognition (e.g., Couper, 2017; Derwing, Diepenbroek, & Foote, 2012; Foote, Trofimovich, Collins, & Urzúa, 2016). The study reported in this dissertation extends this research by investigating pronunciation teaching in a context where it has hitherto been under-researched, namely tertiary EFL in Vietnam. The research involved two phases. Phase 1 was an introductory situation analysis which investigated pronunciation teaching practices of six Vietnamese tertiary EFL teachers teaching six intact classes at a Vietnamese university. First, the representation of pronunciation features in prescribed textbooks and supplementary materials of the EFL programme were analysed. Six ninety-minute lessons (one from each of the teachers) were then observed, and the teachers and 24 students across the six groups interviewed. The teacher interviews included both stimulated recall and general questions probing their beliefs about pronunciation teaching. Students were interviewed in focus groups (four each) regarding their teachers’ pronunciation teaching and their own pronunciation needs. The focus of Phase 1 was on how the teachers taught pronunciation, the factors shaping their pedagogical choices, and the students’ beliefs about their teachers’ pronunciation teaching and their instructional needs. The findings revealed that pronunciation was largely absent from course books and curriculum documents and that the teachers’ beliefs were in contrast with what they actually did in class. The teachers reported that they would follow deliberate steps if they taught pronunciation explicitly such as listening discrimination followed by explaining places of articulation and then practice. However, in the observed lessons, they only corrected their students’ pronunciation errors through recasts and/or prompts, with little if any explicit or pre-planned pronunciation teaching. In the interviews, the teachers confirmed that they never used any other techniques and that this was typically the only way they taught pronunciation in class. The teachers’ pronunciation teaching was textbook-driven and was shaped by contextual factors including the curriculum and the learners. Decision making by all the teachers reflected a general commitment to strictly follow the mandated curriculum, with little evidence of pronunciation being taught explicitly. All the teachers reported a lack of initial training and professional learning in pronunciation pedagogy. In addition, there was a mismatch between the teachers’ and students’ preferences and beliefs about pronunciation teaching. Whereas the teachers believed error correction through recasts and/or prompts was effective, the students did not, and expressed a strong need for more explicit, communicative teaching of pronunciation. This pronunciation instructional need and the teachers’ lack of initial training and PL in pronunciation pedagogy motivated the Phase 2 study. Phase 2 was an intervention study conducted with the same teachers teaching different classes. At the beginning of Phase 2, the teachers attended a teacher professional learning (TPL) workshop in which they were introduced to a pedagogic framework for teaching English pronunciation communicatively proposed by Celce-Murcia, Brinton, & Goodwin (2010). The teachers then planned communicative pronunciation teaching (CPT) lessons using this framework, and were subsequently observed implementing these lessons in their classes. Both the workshop and subsequent classes of this phase were audio-video recorded. A total of seven lesson plans and 24 classroom observations were made across the six teachers (four observations each). Right after the classroom observations, the teachers were interviewed to obtain their views of the TPL workshop and their implementation of the CPT lessons. Twenty-four students across the six groups were interviewed to reflect on their experience with the CPT lessons. Observational data showed that the teachers understood and were able to translate what they learned about CPT from the workshop into actual classroom practice as reflected in their lesson planning and subsequent teaching. The lesson plans designed by the teachers closely followed the principles of the communicative framework. Interview data showed that the CPT model was favoured by both teacher and student participants. On the basis of the teachers’ implementation of the CPT lessons, both the teachers and students were confident that CPT has the advantages for promoting learners’ pronunciation knowledge, fostering their phonological ability, and developing their oral communication skills. They also reported that CPT can arouse learners’ interest and engagement in classroom learning. Taken as a whole, this research highlights the need for pronunciation to be given a more explicit place in teaching and learning in tertiary EFL programmes in Vietnam, and for teachers to be better equipped for teaching pronunciation. Findings from interviews with teachers and learners in the study suggest that they would be receptive to such changes.

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Effect of olutasidenib (FT-2102) on complete remissions in patients with relapsed/refractory (R/R) mIDH1 acute myeloid leukemia (AML): Results from a planned interim analysis of a phase 2 clinical trial.

Journal of Clinical Oncology ◽

10.1200/jco.2021.39.15_suppl.7006 ◽

2021 ◽

Vol 39 (15_suppl) ◽

pp. 7006-7006

Author(s):

Stéphane De Botton ◽

Karen W. L. Yee ◽

Christian Recher ◽

Andrew Wei ◽

Pau Montesinos ◽

...

Keyword(s):

Clinical Trial ◽

High Risk ◽

Median Duration ◽

Interim Analysis ◽

Phase 1 ◽

Median Number ◽

Clinical Activity ◽

Phase 2 ◽

Duration Of Treatment ◽

Transfusion Independence

7006 Background: Olutasidenib, a potent, selective, oral, small molecule inhibitor of mutant IDH1 (m IDH1), has exhibited favorable tolerability and clinical activity in high-risk AML patients (pts) in a phase 1 trial (Watts, Blood 2019). Here, we present interim analysis results of a phase 2 trial (NCT02719574) in R/R m IDH1 AML pts receiving olutasidenib monotherapy 150 mg twice daily. Methods: The efficacy evaluable (EE) set comprised m IDH1R132X pts whose first dose was ≥180 days before the data cut-off (18-JUN-20). The primary endpoint was CR+CRh (complete remission [CR] or CR with partial hematologic recovery [CRh] according to modified IWG 2003 criteria) rate. CRh was defined as bone marrow blasts <5%, absolute neutrophil count >0.5×109/L, and platelet count >50×109/L. Overall response rate (ORR) comprised CR+CRh+CR with incomplete recovery (CRi) + morphologic leukemia-free state (MLFS) + partial response (PR). Duration of treatment (DOT), duration of response (DOR), and overall survival (OS) were estimated using Kaplan-Meier methodology. Results: This clinical trial met its pre-specified early enrollment-stopping criteria for efficacy. A total of 153 pts with R/R AML received olutasidenib; median DOT, 5.5 mo (95% CI: 4.4, 8.7). 43 pts (28%) remain on treatment and 110 (72%) discontinued, most commonly due to: disease progression, 31%; AEs, 14%; death, 10%; and transplant, 8%. For the EE set (123 pts), the median age was 71 y (range: 32‒87) with a median number of prior therapies of 2 (1‒7). The CR+CRh rate was 33% including 30% of pts in CR (Table). Median duration of CR+CRh was not reached (NR) and 13.8 mo in a sensitivity analysis when HSCT or relapse was deemed end of response. ORR was 46% and median duration of ORR was 11.7 mo. Of responders who were transfusion-dependent at baseline, 56-day platelet transfusion independence (TI) and RBC TI were gained by 100% and 83%, respectively, of pts who achieved CR+CRh, and by 56% and 50% who did not. Median OS was 10.5 mo (EE set). In CR+CRh responders, median OS was NR and the estimated 18-mo OS was 87%. TEAEs in ≥25% of pts were nausea, 38%; constipation, 25%; leukocytosis, 25%. Grade 3/4 all-causality TEAEs in >10% of pts were febrile neutropenia, 20%; anemia, 19%; thrombocytopenia, 16%; neutropenia, 13%. Investigator-assessed IDH1 differentiation syndrome (any grade) was observed in 21 pts (14%); most cases resolved with treatment management; one case was fatal; 19 pts had concomitant leukocytosis. Conclusions: Olutasidenib was well tolerated and induced durable CR in a subset of high-risk R/R m IDH1 AML pts. TI was achieved in all response groups. Clinical benefit, per DOR and OS, extended beyond CR+CRh responders. Clinical trial information: NCT02719574. [Table: see text]

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100 Sequential feeding with diets that differ in amino acid content can significantly increase performance of growing and finishing pigs

Journal of Animal Science ◽

10.1093/jas/skz258.167 ◽

2019 ◽

Vol 97 (Supplement_3) ◽

pp. 81-81

Author(s):

Alini Veira ◽

Luan S Santos ◽

Alicia Fraga ◽

Paulo Campos ◽

Raphael Caetano ◽

...

Keyword(s):

Amino Acid ◽

Acid Content ◽

Phase 1 ◽

Amino Acid Content ◽

Experimental Period ◽

Finishing Pigs ◽

Phase 2 ◽

Nutrient Metabolism ◽

Feeding Programs ◽

The Impact

Abstract Recent studies have shown that feed intake, nutrient metabolism and utilization may vary during the 24-h circadian period. In this regard, this study aimed at evaluating the impact on performance from the switching of conventional to sequential feeding programs with diets that differ in amino acid content over the day for growing–finishing pigs. Sixty-eight 25-kg (±2.04) BW barrows were assigned to 4 feeding programs (17 animals per treatment): 1) conventional feeding (CONV), in which pigs received 100% of standardized ileal digestible (SID) AA recommendations for the entire day; 2) sequential feeding (SEQ80-120), providing 80% SID AA recommendations from 2400 to 1159 h and 120% from 1200 to 2359 h; 3) sequential feeding (SEQ70-130) providing 70% SID AA recommendations from 2400 to 1159 h and 130% from 1200 to 2359 h; and 4) sequential feeding (SEQ60-140) providing 60% SID AA recommendations from 2400 to 1159 h and 140% from 1200 to 2359 h. The experimental period lasted 82 d and was subdivided in 3 phases: phase 1 (0 to 28 d), phase 2 (29 to 54 d) and phase 3 (55 to 82 d). The data were analyzed using the MIXED procedure in SAS (SAS Inst. Inc., Cary, NC). SEQ80-120 and SEQ60-140 did not improve performance compared to CONV (P > 0.05). However, ADFI, ADG and BW was higher for SEQ70-130 than CONV during phase 1 (1.49 vs 1.3 kg/d; 0.74 vs 0.65 kg/d; 46.55 vs 43.40 kg, respectively; P < 0.05). During phase 2, BW tended to be higher for SEQ70-130 than CONV (69.20 vs 63.60 kg; P = 0.08). In the entire experimental period, ADFI tended to be higher for SEQ70-130 than CONV (2.08 vs 1.89 kg/d; P = 0.10). According to our results, sequential feeding program improves performance of growing–finishing at the beginning of the period.

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A phase 1 study of azacitidine with high-dose cytarabine and mitoxantrone in high-risk acute myeloid leukemia

Blood Advances ◽

10.1182/bloodadvances.2019000795 ◽

2020 ◽

Vol 4 (4) ◽

pp. 599-606 ◽

Cited By ~ 1

Author(s):

Kirk E. Cahill ◽

Yasmin H. Karimi ◽

Theodore G. Karrison ◽

Nitin Jain ◽

Margaret Green ◽

...

Keyword(s):

Acute Myeloid Leukemia ◽

High Risk ◽

Complete Remission ◽

Myeloid Leukemia ◽

Phase 1 ◽

High Dose ◽

Phase 2 ◽

Phase 1 Study ◽

High Dose Cytarabine ◽

Acute Myeloid

Abstract In this phase 1 study, azacitidine (AZA) was given before high-dose cytarabine (HiDAC) and mitoxantrone (mito) based on the hypothesis that epigenetic priming with a hypomethylating agent before cytotoxic chemotherapy would improve response rates in patients with high-risk acute myeloid leukemia (AML), including relapsed/refractory disease. The primary objective was to establish the recommended phase 2 dose of AZA given before standard HiDAC/mito. In a dose escalation scheme, 46 patients (median age, 66 years) received AZA at 37.5, 50, or 75 mg/m2 subcutaneously or IV once daily on days 1 to 5 followed by HiDAC (3000 mg/m2) and mitoxantrone (30 mg/m2) once each on days 6 and 10 (the HiDAC/mito dose was reduced 33% in elderly subjects). Two dose-limiting toxicities occurred (both in the same patient): acute liver failure and kidney injury at the 50 mg/m2 dose. The 30-day induction death rate was 2.2% (1 of 46). The overall response rate, including complete remission and complete remission with incomplete count recovery, was 61% (28 of 46). Previously untreated patients aged ≥60 years with therapy-related AML and de novo AML were more likely to respond than untreated patients with AML progressing from an antecedent hematologic disorder (myelodysplastic syndrome and chronic myelomonocytic leukemia). Patients with favorable European Leukemia Network risk (P = .008), NPM1 mutations (P = .007), or IDH2 mutations (P = .03) were more likely to respond, and those with TP53 mutations (P = .03) were less likely to respond. The recommended phase 2 dose of AZA is 75 mg/m2 per day on days 1 to 5 followed by HiDAC (3000 mg/m2) and mitoxantrone (30 mg/m2) once each on days 6 and 10. This trial was registered at www.clinicaltrials.gov as #NCT01839240.

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The Impact of Screening Psychiatric Comorbidity and High-risk Feedback on Liaison Psychiatric Consultation Rates and Clinicians’ Attitudes on a Neurology Ward

European Psychiatry ◽

10.1016/j.eurpsy.2017.01.025 ◽

2017 ◽

Vol 41 (S1) ◽

pp. S53-S53

Author(s):

R. Van Damme ◽

G. Portzky ◽

P. Boon ◽

G.M.D. Lemmens

Keyword(s):

High Risk ◽

Psychiatric Comorbidity ◽

Psychiatric Services ◽

Study Phase ◽

Neurological Patients ◽

Screening Protocol ◽

Competing Interest ◽

The Impact ◽

Neurological Ward ◽

Feedback Phase

IntroductionLifetime prevalence of psychiatric comorbidity in neurological patients is as high as 55%, but it remains often undetected and therefore untreated in hospital settings. Further, clinicians tend to make little use of the consultative and liaison psychiatric team for detection and treatment of anxiety and mood disorders in neurological patients. The current study aimed to investigate whether the implementation of a stepped screening protocol with high risk feedback to the clinician had an influence on the use of consultative and liaison psychiatric services.MethodAll patients admitted to the neurological ward were assessed using a stepped screening protocol for depression, anxiety and substance use during 15 months. Positive screening resulted in feedback to the clinicians depending on the study phase (e.g. feedback vs. no feedback).ResultsNo differences were found in the use of consultative and liaison psychiatric services during the non-feedback and feedback phase.ConclusionScreening and high risk feedback of psychiatric comorbidity in neurological patients does not increase psychiatric referral rates. It points to the necessity of a more integrated collaborative care model for detection and treatment of psychiatric comorbidity.Disclosure of interestThe authors have not supplied their declaration of competing interest.

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ZUMA-8: A phase 1/2 multicenter study evaluating KTE-X19 in patients (pts) with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL).

Journal of Clinical Oncology ◽

10.1200/jco.2019.37.15_suppl.tps7566 ◽

2019 ◽

Vol 37 (15_suppl) ◽

pp. TPS7566-TPS7566 ◽

Cited By ~ 1

Author(s):

Ian Flinn ◽

Michael Marris ◽

William G. Wierda ◽

Steven Coutre ◽

John M. Pagel ◽

...

Keyword(s):

High Risk ◽

Multicenter Study ◽

Residual Disease ◽

Phase 1 ◽

Objective Response ◽

Progression Free Survival ◽

Lymphocytic Leukemia ◽

Phase 2 ◽

T Cell Therapy ◽

Patient Reported

TPS7566 Background: Despite treatment advances, CLL is largely incurable. First-line targeted therapy with ibrutinib mostly produces durable remissions, but high-risk disease or many prior therapies increases relapse risk (Ghia P, et al. Haematologica. 2014). Relapse after ibrutinib is associated with a poor outcome (Maddocks KJ, et al. JAMA Oncol. 2015). Allogeneic stem cell transplantation potentially offers long-term remissions but has a high risk of morbidity/mortality (Shustik C, et al. Ann Hematol. 2017). Autologous T cells expressing a CD19-specific chimeric antigen receptor (CAR) with a CD28 costimulatory domain may be efficacious against CLL (Kochenderfer JN, et al. Blood. 2012). KTE-X19 is an autologous anti-CD19 CAR T cell therapy under investigation for R/R hematologic malignancies and may offer longer durable remissions with manageable safety in pts with R/R CLL. ZUMA-8 is a Phase 1/2 multicenter study for pts with R/R CLL. Methods: Adult pts must have R/R CLL with ≥ 2 prior treatment regimens, disease progression on ibrutinib, ECOG 0-1, and adequate organ function. Phase 1 will enroll 12-18 pts to assess dose-limiting toxicities (DLTs) with a 6 + 3 dose escalation/de-escalation design; 30 more pts may be enrolled to further assess safety. Phase 2 will enroll ≈60 pts to evaluate efficacy and safety. Pts will undergo leukapheresis followed by optional bridging therapy. Cyclophosphamide (500 mg/m2) and fludarabine (30 mg/m2) conditioning chemotherapy will be given on Days -5, -4 and -3. KTE-X19 will be given on Day 0 at 0.5, 1 or 2 × 106 KTE-X19 cells/kg. The primary endpoint is incidence of DLTs for Phase 1 and independent review committee-assessed objective response rate (ORR) per iwCLL 2018 criteria for Phase 2. Secondary endpoints include complete remission (CR) rate, investigator-assessed ORR, minimal residual disease (MRD) negativity rate, MRD-negative CR rate, duration of response, progression-free survival, overall survival, safety, and patient-reported outcomes (Phase 2). Serum cytokine and blood KTE-X19 cell levels over time and level of anti-KTE-X19 antibodies are exploratory endpoints. Accrual is ongoing. Clinical trial information: NCT03624036.

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An evaluation of foundation doctor training: a mixed-methods study of the impact on workforce well-being and patient care [the Evaluating the Impact of Doctors in Training (EDiT) study]

Health Services and Delivery Research ◽

10.3310/hsdr01150 ◽

2013 ◽

Vol 1 (15) ◽

pp. 1-208 ◽

Cited By ~ 3

Author(s):

S Mason ◽

C O’Keeffe ◽

A Carter ◽

R O’Hara ◽

C Stride

Keyword(s):

Health Care ◽

Quality Of Care ◽

Longitudinal Study ◽

Phase 1 ◽

Well Being ◽

Junior Doctors ◽

Phase 2 ◽

Adequate Quality ◽

The Impact

BackgroundA major reform of junior doctor training was undertaken in 2004–5, with the introduction of foundation training (FT) to address perceived problems with work structure, conditions and training opportunities for postgraduate doctors. The well-being and motivation of junior doctors within the context of this change to training (and other changes such as restrictions in working hours of junior doctors and increasing demand for health care) and the consequent impact upon the quality of care provided is not well understood.ObjectivesThis study aimed to evaluate the well-being of foundation year 2 (F2) doctors in training. Phase 1 describes the aims of delivering foundation training with a focus on the role of training in supporting the well-being of F2 doctors and assesses how FT is implemented on a regional basis, particularly in emergency medicine (EM). Phase 2 identifies how F2 doctor well-being and motivation are influenced over F2 and specifically in relation to EM placements and quality of care provided to patients.MethodsPhase 1 used semistructured interviews and focus groups with postgraduate deanery leads, training leads (TLs) and F2 doctors to explore the strategic aims and implementation of FT, focusing on the specialty of EM. Phase 2 was a 12-month online longitudinal study of F2 doctors measuring levels of and changes in well-being and motivation. In a range of specialties, one of which was EM, data from measures of well-being, motivation, intention to quit, confidence and competence and job-related characteristics (e.g. work demands, task feedback, role clarity) were collected at four time points. In addition, we examined F2 doctor well-being in relation to quality of care by reviewing clinical records (criterion-based and holistic reviews) during the emergency department (ED) placement relating to head injury and chronic obstructive pulmonary disease (COPD).ResultsPhase 1 of the study found that variation exists in how successfully FT is implemented locally; F2 lacks a clearly defined end point; there is a minimal focus on the well-being of F2 doctors (only on the few already shown to be ‘in difficulty’); the ED presented a challenging but worthwhile learning environment requiring a significant amount of support from senior ED staff; and disagreement existed about the performance and confidence levels of F2 doctors. A total of 30 EDs in nine postgraduate medical deaneries participated in phase 2 with 217 foundation doctors completing the longitudinal study. F2 doctors reported significantly increased confidence in managing common acute conditions and undertaking practical procedures over their second foundation year, with the biggest increase in confidence and competence associated with their ED placement. F2 doctors had levels of job satisfaction and anxiety/depression that were comparable to or better than those of other NHS workers, and adequate quality and safety of care are being provided for head injury and COPD.ConclusionsThere are ongoing challenges in delivering high-quality FT at the local level, especially in time-pressured specialties such as EM. There are also challenges in how FT detects and manages doctors who are struggling with their work. The survey was the first to document the well-being of foundation doctors over the course of their second year, and average scores compared well with those of other doctors and health-care workers. F2 doctors are benefiting from the training provided as we found improvements in perceived confidence and competence over the year, with the ED placement being of most value to F2 doctors in this respect. Although adequate quality of care was demonstrated, we found no significant relationships between well-being of foundation doctors and the quality of care they provided to patients, suggesting the need for further work in this area.FundingThe National Institute for Health Research Health Services and Delivery Research programme.

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