Barriers and facilitators to implementing a pragmatic trial to improve advance care planning in the nursing home setting.

BACKGROUND: The PRagmatic trial Of Video Education in Nursing homes (PROVEN) aims to test the effectiveness of an advance care planning (ACP) video intervention. Relatively little is known about the challenges associated with implementing ACP interventions in the nursing home (NH) setting, especially within a pragmatic trial. To address this research gap, this report sought to identify facilitators of and barriers to implementing PROVEN from the perspective of the Champions charged with introducing the ACP video program delivery to patients and families. METHODS: In semi-structured telephone interviews at 4 and 15 months of the 18-month implementation period, ACP Champions at all PROVEN intervention facilities (N = 119) were asked about their perceptions of program implementation. Forty interviews were purposively sampled, transcribed, and analyzed using a hybrid deductive/inductive approach to thematic analysis incorporating the Consolidated Framework for Implementation Research's domains: Intervention Characteristics (IC), Inner Setting (IS), Characteristics of Individuals (CI), Outer Setting (OS), and Process (P). RESULTS: Implementation facilitators identified by Champions included: the intervention's adaptable mode of presentation and minimal time burden (IC) as well as the program's customizable delivery to patients and families and opportunity for group reflection on implementation among ACP Champions (P). Barriers included mandated protocol-driven aspects of the program (OS), limited time to deliver the intervention (IS), and lack of perceived relevance and emotional readiness for ACP amongst stakeholders (CI). CONCLUSIONS: Despite the promise of PROVEN's intervention for improving ACP in nursing homes, unchangeable setting and characteristics of Champions, patients, and family members presented implementation barriers. Researchers need to engage all program participants (i.e., facility staff, patients, and families), in addition to corporate-level stakeholders, in early pragmatic trial design to minimize such obstacles. Further, despite the facilitating nature of PROVEN's implementation processes, the study encountered tension between scientific rigor and real-world demands. Researchers need to optimize the real-world authenticity of pragmatic trial design while avoiding excessive implementation protocol deviations. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT02612688. Registered 19 November 2015.

Dose Dependencies and Biocompatibility of Renal Clearable Gold Nanoparticles: From Mice to Non-human Primates.

While dose dependencies in pharmacokinetics and clearance are often observed in clinically used small molecules, very few studies have been dedicated to the understandings of potential dose-dependent in vivo transport of nanomedicines. Here we report that the pharmacokinetics and clearance of renal clearable gold nanoparticles (GS-AuNPs) are strongly dose-dependent once injection doses are above 15 mg kg-1 : high dose expedited the renal excretion and shortened the blood retention. As a result, the no-observed-adverse-effect-level (NOAEL) of GS-AuNPs was >1000 mg kg-1 in CD-1 mice. The efficient renal clearance and high compatibility can be translated to the non-human primates: no adverse effects were observed within 90 days after intravenous injection of 250 mg kg-1 GS-AuNPs. These fundamental understandings of dose effect on the in vivo transport of ultrasmall AuNPs open up a pathway to maximize their biomedical potentials and minimize their toxicity in the future clinical translation.

In†Vivo X-ray Imaging of Transport of Renal Clearable Gold Nanoparticles in the Kidneys.

With more and more engineered nanoparticles (NPs) being designed renal clearable for clinical translation, fundamental understanding of their transport in the different compartments of kidneys becomes increasingly important. Here, we report noninvasive X-ray imaging of renal clearable gold NPs (AuNPs) in normal and nephropathic kidneys. By quantifying the transport kinetics of the AuNPs in cortex, medulla and pelvis of the normal and injured kidneys, we found that ureteral obstruction not just blocked the NP elimination through the ureter but also slowed down their transport from the medulla to pelvis and enhanced the cellular uptake. Moreover, the transport kinetics of the NPs and renal anatomic details can be precisely correlated with local pathological lesion. These findings not only advance our understandings of the nano-bio interactions in kidneys but also offer a new pathway to noninvasively image kidney dysfunction and local injuries at the anatomical level.

The introduction of a Surgical Care Practitioner training programme to an acute National Health Service trust and an exploration of the interrelationships between Surgical Care Practitioners, their trainers and surgical trainees.

This study aimed to explore the impact of the introduction of a Surgical Care Practitioner programme on junior surgical training within an acute National Health Service trust. A qualitative methodology of semi-structured interviews was used to gather information from eight Surgical Care Practitioners, eight surgical trainees and eight consultant grade trainers. The authors found an overall positive and mutually beneficial outcome of the training programme, with surgical trainees unanimous that the presence of the Surgical Care Practitioners freed them up for more time to be spent in theatre, as well as acting as highly experienced surgical assistants when the trainees were operating on their own. This study found significant mutual benefits to surgical trainees and Surgical Care Practitioners, as well as smoother running of the wards, theatres and the clinical firms through the addition of a highly skilled and versatile Surgical Care Practitioner workforce.

Challenges to getting evidence into practice: expert clinician perspectives on psychotherapy for personality disorders.

BACKGROUND: No known recent studies have investigated service provision for personality disorder in Australia, despite international studies suggesting provision of such services is sub-optimal. AIMS: This study aimed to gain insight into psychotherapy provided for personality disorders, treatments considered optimal by clinicians and opinions of clinicians on the current levels of care. METHODS: The views of 60 experienced clinicians working with personality disorders were sampled. RESULTS: Data showed significant gaps between current practices for the treatment of personality disorders provided by clinicians compared to their perceptions of optimal treatment practice. CONCLUSIONS: This study highlights the evidence-practice gap and the need for more training for clinicians in the treatment of personality disorders and service improvements to implement optimal care strategies.

Enhancing memory in late-life depression: the effects of a combined psychoeducation and cognitive training program.

OBJECTIVE: To evaluate the efficacy of a multifactorial cognitive training (CT) program for older people with a lifetime history of depressive disorder. METHODS: This was a single-blinded waitlist control design. The study was conducted in the Healthy Brain Ageing Clinic, a specialist outpatient clinic at the Brain & Mind Research Institute, Sydney, Australia. Forty-one participants (mean age = 64.8 years, sd = 8.5) with a lifetime history of major depression were included. They were stabilized on medication and had depressive symptoms in the normal to mild range. The intervention encompassed both psychoeducation and CT. Each component was 1-hour in duration and was delivered in a group format over a 10-week period. Psychoeducation was multifactorial, was delivered by health professionals and targeted cognitive strategies, as well depression, anxiety, sleep, vascular risk factors, diet and exercise. CT was computer-based and was conducted by Clinical Neuropsychologists. Baseline and follow-up neuropsychological assessments were conducted by Psychologists who were blinded to group allocation. The primary outcome was memory whilst secondary outcomes included other aspects of cognition and disability. RESULTS: CT was associated with significant improvements in visual and verbal memory corresponding to medium to large effect sizes. CONCLUSION: CT may be a viable secondary prevention technique for late-life depression, a group who are at risk of further cognitive decline and progression to dementia.

What Do Individuals With Borderline Personality Disorder Want From Treatment? A Study of Self-generated Treatment and Recovery Goals.

Outcome measurement has progressed in the field of personality disorders. While the majority of trials have evaluated outcomes on the basis of symptom and diagnostic indices, what is considered a meaningful and valued outcome to individuals has seldom been investigated. Self-generated treatment goals were collected from 102 individuals seeking treatment for borderline personality disorder and independently coded by 2 raters. Responses were content-analyzed to determine the categories of goals people want for treatment. A total of 464 individual goal units across 4 main goal types emerged in the content analysis: reducing symptoms, improved well-being, better interpersonal relationships, and having a greater sense of self. Although the reduction of symptoms was the most commonly reported goal, 88.2% reported wanting better psychosocial functioning, including improvements in relationships, vocation, and self-understanding. The existence of the wide range of goals suggests that there is a need for clinicians to establish a collaborative formulation of treatment goals with individuals to ensure that treatment is personalized and meaningful.

A dynamic application of PRECIS-2 to evaluate implementation in a pragmatic, cluster randomized clinical trial in two nursing home systems.

BACKGROUND: PRECIS-2 (PRagmatic Explanatory Continuum Indicator Summary-2) can assess how clinical trial design decisions (along the explanatory-pragmatic continuum) influence the applicability of trial results to intended stakeholders. The tool has been used to assess features of trials during the trial design phase and also upon completion. The ongoing PRagmatic trial Of Video Education in Nursing homes (PROVEN), which is evaluating the effectiveness of a suite of videos to improve advance care planning, is one of the first large pragmatic, cluster randomized trials within nursing home health care systems. While certain features of pragmatic trials remain static once designed (e.g., recruitment, outcomes), successful implementation of a system-wide program requires on-going evaluation and adaptation. This report's objectives were to apply PRECIS-2 in a novel manner during the actual conduct of the PROVEN trial to assess how dynamic adaptations shifted implementation to either a more explanatory or a more pragmatic approach. METHODS: We assessed PROVEN's protocol as initially designed according to the three PRECIS-2 domains pertinent to implementation: (1) Organization, (2) Flexibility-Delivery, and (3) Flexibility-Adherence. We then applied this framework to conduct a formative evaluation of decisions made while the trial was ongoing to adapt the implementation approach along the pragmatic versus the explanatory continuum in response to emergent challenges. RESULTS: Based on the PRECIS-2 rubric, the initial design of the PROVEN implementation approach reflected a hybrid of pragmatic and explanatory features. Most notably, within the Flexibility-Delivery, the trial had a relatively pragmatic approach to protocol delivery by front-line nursing home providers, balanced with a more explanatory approach to protocol monitoring enabled by the analytic capabilities of the research team. This more intensive monitoring proved critical in revealing implementation problems once the study began. Dynamic adaptations made in response to these challenges generally reflected shifts to more explanatory approaches within the Flexibility-Delivery and Flexibility-Adherence domains including ever more intensive compliance monitoring, as well as detailed coaching of front-line providers delivering the intervention by the research team. CONCLUSIONS: Pragmatic trials conducted in the nursing home setting may benefit from a more dynamic approach to implementation. Allowing fluidity between pragmatic and explanatory features may still preserve the trial's applicability to intended stakeholders' needs. PRECIS-2 provides a useful formative evaluation tool to assess these adaptations in "real-time." TRIAL REGISTRATION: US National Library of Medicine, ClinicalTrials.gov, ID: NCT02612688 . Registered on 19 November 2015.

Expressive language disturbance in borderline personality disorder in response to emotional autobiographical stimuli.

Clinicians recognize expressive language disturbances in borderline personality disorder (BPD) as a feature attenuating psychiatric history-taking. Neuroimaging studies demonstrate activation of key differentiating neural networks characterizing a traumatic memory system in BPD patients. Yet there are few BPD studies evaluating expressive language disturbances in response to emotionally salient, clinically relevant stimuli and no controlled studies. The aim was to examine expressive language disturbances in response to a clinically relevant emotional stimulus, the Adult Attachment Interview (AAI). Twenty BPD participants and 20 age-, sex-, and education-matched controls were administered the AAI. Verbatim transcripts were analyzed by four computerized measures designed to evaluate various linguistic components of speech (i.e., overall expressive language impairment, lexical complexity, syntactic complexity, and semantic complexity). BPD participants evidenced significantly greater levels of overall expressive language impairment and reduced syntactic and lexical complexity, but not semantic complexity scores. Detailed linguistic profiles demonstrated specific deficits linked to BPD.

Early intervention for cognitive decline: is there a role for multiple medical or behavioural interventions?

AIM: Early medical or behavioural intervention to slow cognitive decline might be a viable strategy for reducing disability and rates of institutional care in older persons. This paper details the published work supporting cross-sectional and longitudinal associations between vascular risk factors, depressive symptoms and progressive cognitive decline. Evidence for the beneficial effects of providing relevant interventions is assessed. METHODS: Relevant published work from the areas of dementia research, 'vascular depression' and the cognitive benefits that might result from treating vascular risk factors, managing depression or promoting nutrition, cognitive or physical exercise was ascertained from electronic database searches and recent reviews of key areas. RESULTS: The existing published work does not provide many examples of early intervention strategies that target vascular strategies or active treatment of depression to reduce the rate of cognitive decline. Most studies have major limitations including the evaluation of only single-risk-factor interventions, the observational designs and the inadequate measurement of cognition. An optimal early intervention strategy might be to target multiple risk factors within relevant experimental or health service frameworks. CONCLUSIONS: Early identification and multifaceted reduction of vascular risk factors, active management of depression, engagement in cognitive activity and physical exercise and promotion of better nutrition might together help to slow some forms of cognitive decline or progression to dementia. This health services approach now requires systematic evaluation.