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"Milligan, Peter"
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Justice League dark. Volume 1, In the dark
\"The witch known as The Enchantress has gone mad, unleashing a wave of chaos that not even the combined powers of Superman, Batman, Wonder Woman and Cyborg can stop. Shade the Changing Man, Madame Xanadu, Deadman, Zatanna, Mindwarp and John Constantine may be our only hope - but how can we put our trust in beings whose very presence makes ordinary people break out in a cold sweat? Critically acclaimed writer Peter Milligan brings together an unorthodox team for the most unnatural threats.\"--P. [4] of cover.
Book
Piloting a mental health training programme for community health workers in South Africa: an exploration of changes in knowledge, confidence and attitudes
Background
There is a shortage of trained mental health workers in spite of the significant contribution of psychiatric disorders to the global disease burden. Task shifting, through the delegation of health care tasks to less specialised health workers such as community health workers (CHWs), is a promising approach to address the human resource shortage. CHWs in the Western Cape province of South Africa provide comprehensive chronic support which includes that for mental illness, but have thus far not received standardized mental health training. It is unknown whether a structured mental health training programme would be acceptable and feasible, and result improved knowledge, confidence and attitudes amongst CHWs.
Methods
We developed and piloted a mental health training programme for CHWs, in line with the UNESCO guidelines; the WHO Mental Health Gap Action Programme and the South African National framework for CHW training. In our quasi-experimental (before-after) cohort intervention study we measured outcomes at the start and end of training included: 1) Mental health knowledge, measured through the use of case vignettes and the Mental Health Knowledge Schedule; 2) confidence, measured with the Mental Health Nurse Clinical Confidence Scale; and 3) attitudes, measured with the Community Attitudes towards the Mentally Ill Scale. Knowledge measures were repeated 3 months later. Acceptability data were obtained from daily evaluation questionnaires and a training evaluation questionnaire, while feasibility was measured by participant attendance at training sessions.
Results
Fifty-eight CHWs received the training, with most (
n
= 56, 97.0%) attending at least 7 of the 8 sessions. Most participants (
n
= 29, 63.04%) demonstrated significant improvement in knowledge, which was sustained at 3-months. There was significant improvement in confidence, along with changes in attitude, indicating improved benevolence, reduced social restrictiveness, and increased tolerance to rehabilitation of the mentally ill in the community but there was no change in authoritarian attitudes. The training was acceptable and feasible.
Conclusions
Mental health training was successful in improving knowledge, confidence and attitudes amongst trained CHWs. The training was acceptable and feasible. Further controlled studies are required to evaluate the impact of such training on patient health outcomes.
Trial registration
PACTR
PACTR201610001834198
, Registered 26 October 2016.
Journal Article
X-Men
\"A new X-Men era begins, courtesy of Peter Milligan! The X-Men travel to Antarctica after an S.O.S. from a colony of mutants, but what they find is shocking: bodies everywhere and the word \"Golgotha\" written on the walls in blood! With Emma Frost offering cryptic answers and madness beginning to gnaw at their minds, can the X-Men keep the rest of the planet from suffering the colony's gruesome fate? Then, a bizarre love triangle threatens to tear apart the team -- or at the very least, leave Rogue flaming mad with Gambit! Why does Mystique want to join the X-Men? And will the team grant membership to its old foe?! And an investigation into mutated animals in Africa leads Storm and the X-Men into a wild adventure -- alongside the Black Panther!\"--Back cover of volume 1.
BOOK
Model‐informed drug development of autologous CAR‐T cell therapy: Strategies to optimize CAR‐T cell exposure leveraging cell kinetic/dynamic modeling
Autologous Chimeric antigen receptor (CAR‐T) cell therapy has been highly successful in the treatment of aggressive hematological malignancies and is also being evaluated for the treatment of solid tumors as well as other therapeutic areas. A challenge, however, is that up to 60% of patients do not sustain a long‐term response. Low CAR‐T cell exposure has been suggested as an underlying factor for a poor prognosis. CAR‐T cell therapy is a novel therapeutic modality with unique kinetic and dynamic properties. Importantly, “clear” dose‐exposure relationships do not seem to exist for any of the currently approved CAR‐T cell products. In other words, dose increases have not led to a commensurate increase in the measurable in vivo frequency of transferred CAR‐T cells. Therefore, alternative approaches beyond dose titration are needed to optimize CAR‐T cell exposure. In this paper, we provide examples of actionable variables – design elements in CAR‐T cell discovery, development, and clinical practice, which can be modified to optimize autologous CAR‐T cell exposure. Most of these actionable variables can be assessed throughout the various stages of discovery and development as part of a well‐informed research and development program. Model‐informed drug development approaches can enable such study and program design choices from discovery through to clinical practice and can be an important contributor to cell therapy effectiveness and efficiency.
Journal Article
Flashpoint. The world of Flashpoint, featuring Batman
\"Flashpoint has changed the DC Universe, and nothing is as it was before. Now Batman is Thomas Wayne, driven by the death of his son Bruce to punish criminals, and in pursuit of a Joker whose twisted crimes will bring him to the brink of madness himself ... Now, Dick Grayson travels with his parents and the death-defying Deadman across war-torn Europe, performing in their circus until an Amazon attack leads them to their true fate ... In this world, Deathstroke is a pirate on the world's most dangerous waters, questing for the only treasure that really matters ... Shade the Changing Man leads a secret team of bizarre heroes, but will he lead them to their deaths?\"--P. [4] of cover.
Book
Open Systems Pharmacology Community—An Open Access, Open Source, Open Science Approach to Modeling and Simulation in Pharmaceutical Sciences
Open Systems Pharmacology is a community that develops, qualifies, and shares professional open source software tools and models in a collaborative open‐science way. [...]because of the generic relevance of pharmacokinetics in any pharmaceutical application, PBPK has seen the most rapid growth in terms of the number of organizations and scientists applying it and the published case studies. OSP offers professional open access and open source software tools (PK‐Sim/MoBi) and models via a platform for collaborative development and qualification. The provision of a sufficient package of successful prediction case studies Full transparency of the approach, processes, tools, and models used For any specific use such as first‐in‐man, drug–drug interactions, or kinetics in special populations, a series of overall successful prospective predictions is needed, and for none of the popular platforms has a general qualification scheme been established yet.
Journal Article
Batman, the caped crusader
\"A new collection featuring the legendary 1980s Batman epics \"Ten Nights of the Beast\" and \"A Death in the Family\", never before collected! This new collection of 1980s Batman tales includes the legendary story \"A Death in the Family,\" in which the Joker ends up killing the secon Robin, Jason Todd. It all begins with the story \"Ten Nights of the Beast,\" which introduced the deadly post-Soviet villain known as the KGBeast. Following that, a series of stories concerning organized crime in the streets of Gotham City leads into \"A Death in the Family,\" in which Robin follows a trail to find his birth mother, who is in cahoots with the Joker.\"-- Provided by publisher.
Book
Comparing dedicated and designated models of integrating mental health into chronic disease care: study protocol for a cluster randomized controlled trial
Background
In low- and middle-income countries (LMIC), it is uncertain whether a “dedicated” approach to integrating mental health care (wherein a community health worker (CHW) has the sole responsibility of delivering mental health care) or a “designated” approach (wherein a CHW provides this service in addition to usual responsibilities) is most effective and cost-effective. This study aims to compare the effectiveness and cost-effectiveness of these two models of service integration relative to treatment as usual (TAU) for improving mental health and chronic disease outcomes among patients with HIV or diabetes.
Methods/Design
This is a cluster randomised trial. We will randomise 24 primary health care facilities in the Western Cape Province of South Africa to one of three study arms. Within each cluster, we will recruit 25 patients from HIV and 25 from diabetes services for a total sample of 1200 participants. Eligible patients will be aged 18 years or older, take medication for HIV or diabetes, and screen positive on the Alcohol Use Disorder Identification Test for hazardous/harmful alcohol use or depression on the Centre for Epidemiology Scale on Depression. Participants recruited in clinics assigned to the designated or dedicated approach will receive three sessions of motivational interviewing and problem-solving therapy, while those recruited at TAU-assigned clinics will be referred for further assessment. Participants will complete an interviewer-administered questionnaire at baseline, and at 6 and 12 months post-enrolment to assess change in self-reported outcomes. At these end points, we will test HIV RNA viral load for participants with HIV and HbA1c levels for participants with diabetes. Primary outcomes are reductions in self-reported hazardous/harmful alcohol use and risk of depression. Secondary outcomes are improvements in adherence to chronic disease treatment, biomarkers of chronic disease outcomes, and health-related quality of life. Mixed-effect linear regression models will model the effect of the interventions on primary and secondary outcomes. The cost-effectiveness of each approach will be assessed using incremental cost-effectiveness ratios.
Discussion
Study findings will guide decision-making around how best to integrate mental health counselling into chronic disease care in a LMIC setting.
Trial registration
Pan African Clinical Trials Registry, Trial registration number:
ACTR201610001825403
. Registered 17 October 2016.
Journal Article
Modeling and simulations relating overall survival to tumor growth inhibition in renal cell carcinoma patients
Purpose
To assess the link between tumor growth inhibition (TGI) and overall survival (OS) based on historical renal cell carcinoma (RCC) data. To illustrate how simulations can help to identify TGI thresholds based on target OS benefit [i.e., hazard ratio (HR) compared with standard of care] to support new drug development in RCC.
Methods
Tumor size (TS) data were modeled from 2552 patients with first-line or refractory RCC who received temsirolimus, interferon, sunitinib, sorafenib or axitinib in 10 Phase II or Phase III studies. Three model-based TGI metrics estimates [early tumor shrinkage (ETS) at week 8, 10 or 12, time to tumor growth (TTG) and growth rate] as well as baseline prognostic factors were tested in multivariate lognormal models of OS. Model performance was evaluated by posterior predictive check of the OS distributions and hazard ratio across treatments.
Results
TTG was the best TGI metric to predict OS. However, week 8 ETS had a satisfactory performance and was employed in order to maximize clinical utilization. The week 8 ETS to OS model was then used to simulate clinically relevant ETS thresholds for future Phase II studies with investigational treatments.
Conclusions
The published OS model and resultant simulations can be leveraged to support Phase II design and predict expected OS and HR (based on early observed TGI data obtained in Phase II or Phase III studies), thereby informing important mRCC development decisions, e.g., Go/No Go and dose regimen selection.
Journal Article
Improving adherence in mental health service users with severe mental illness in South Africa: a pilot randomized controlled trial of a treatment partner and text message intervention vs. treatment as usual
Objectives
Medication non-adherence is a significant problem in treatment of severe mental disorders and is associated with poor clinical outcomes and increased demand on services. Task-shifting interventions incorporating mobile health may improve adherence in mental health service users in low- and middle-income countries. Seventy-seven participants were recruited from a psychiatric hospital in Cape Town, with 42 randomized to receive the intervention and 35 to treatment as usual. Intervention pairs underwent treatment-partner contracting and psychoeducation, and received monthly text message reminders of clinic appointments. Primary outcomes were intervention acceptability and feasibility. Secondary outcome for efficacy were adherence to clinic visit; relapse; quality of life; symptomatic relief and medication adherence.
Results
Treatment partner and psychoeducation components were acceptable and feasible. The text message component was acceptable but not feasible in its current form. Efficacy outcomes favoured the intervention but did not reach statistical significance. A treatment-partner intervention is acceptable and feasible in a low- and middle-income setting. Work is needed to ensure that additional components of such interventions are tailored to the local context. Appropriately powered efficacy studies are needed.
Trial Registration
PACTR PACTR201610001830190, Registered 21 October 2016 (Retrospectively registered)
Journal Article