Prospective Cohort Study

https://escholarship.org/content/qt1r33f4p8/qt1r33f4p8.pdf?t=qho8bi

Dementia prevention, intervention, and care: 2020 report of the Lancet Commission.

Pathology and genetics of tumours of the urinary system and male genital organs

A rating scale for drug-induced akathisia has been derived that incorporates diagnostic criteria for pseudoakathisia, and mild, moderate, and severe akathisia. It comprises items for rating the observable, restless movements which characterise the condition, the subjective awareness of restlessness, and any distress associated with the akathisia. In addition, there is an item for rating global severity. A standard examination procedure is recommended. The inter-rater reliability for the scale items (Cohen's kappa) ranged from 0.738 to 0.955. Akathisia was found in eight of 42 schizophrenic in-patients, and nine had pseudoakathisia, where the typical sense of inner restlessness was not reported.

A rating scale for drug-induced akathisia

/pdf/about-the-national-institute-for-health-and-care-excellence-4zmiguft2a.pdf

About the National Institute for Health and Care Excellence - NICE.

Failure to account for baseline utilities/costs imbalance between treatment groups in cost-effectiveness analyses can result in biased estimates and mislead the decision making process. The currently recommended adjustment approach is linear regression, with estimates that are typically evaluated at the mean of the baseline utilities/costs. However, a problem arises whenever there are some missing follow-up values and the evaluation is restricted to the complete cases. Should the mean of the complete cases or the available cases baseline utilities/costs be used in generating the adjusted estimates? To our knowledge there is no current guideline about this choice in the literature, with standard software implementations often implicitly selecting one of the methods. We use two trials as motivating examples to show that the two approaches can lead to substantially different conclusions for healthcare decision making and that standard approaches which automatically resort to complete case analysis are potentially dangerous and biased. Analysts should therefore consider methods that can explicitly incorporate missing data assumptions and assess the robustness of the results to a range of plausible alternatives.

Pitfalls of adjusting for mean baseline utilities/costs in trial-based cost-effectiveness analysis with missing data

LiGHT: Laser in Glaucoma and Ocular Hypertension Trial – Methodology and Baseline characteristics of a multicentre randomised controlled trial.

This analysis plan sets out the methods of analysing the predetermined primary, secondary
and health economic outcomes for ANTLER, which will be reported in the National Institute
for Health Research, Health Technology Assessment report at the end of the trial and also in
the main peer review paper(s) to result from this randomised controlled trial.
The analysis and reporting of this trial will conform to the CONSORT and CHEERS
statements and the appropriate standard operating procedures written by Priment Clinical
Trials Unit.
Further information on this trial can be found in the protocol version 7.0 (26/11/2018). The
protocol is stored on: S:\Pop_Health\PCPH_Priment\Projects\Current\CTIMPS\ANTLER\6.
Protocol\ANTLER_protocol_v7_20181126.pdf.

ANTLER statistical analysis plan, Version 3, 16 January 2020

Background: Mild or pre-frailty is common yet potentially reversible. Preventing progression to worsening frailty may benefit individuals and lower health/social care costs. However, we know little about effective approaches to preventing frailty progression.
Objectives: 
To develop an evidence and theory-based home-based health promotion intervention for older people with mild frailty.
To test feasibility, costs and acceptability of the intervention, and of a full-scale clinical and cost-effectiveness Randomised Controlled Trial (RCT).
Design: Evidence reviews, qualitative studies, intervention development, feasibility RCT with process evaluation.
Intervention development: Two systematic reviews (including systematic searches of 14 databases and registries, 1990-2016 and 1980-2014), a state-of-the-art review (inception-2015) and policy review identified effective components for our intervention. 
We collected data on health priorities and potential intervention components from semi-structured interviews and focus groups with older people (n=44), carers (n=12) and health/social care professionals (n=27). These data, and our evidence reviews, fed into development of the ‘HomeHealth’ intervention in collaboration with older people and multi-disciplinary stakeholders. 
‘HomeHealth’ comprised 3-6 sessions with a support worker trained in behaviour change techniques, communication skills, exercise, nutrition and mood. Participants addressed self-directed independence and wellbeing goals, supported through education, skills-training, enabling individuals to overcome barriers, providing feedback, maximising motivation and promoting habit formation.
Feasibility RCT: Single-blind RCT, individually-randomised to ‘HomeHealth’ or Treatment-As-Usual (TAU).
Setting: Community settings in London and Hertfordshire, United Kingdom. 
Participants: 51 community-dwelling adults aged 65years+ with mild frailty
Main outcome measures: Feasibility: recruitment, retention, acceptability, intervention costs
Clinical and health economic outcome data at 6 months included: Functioning, frailty status, well-being, psychological distress, quality of life, capability, NHS and societal service utilisation/costs.
Results: We successfully recruited to target, with good 6 months retention (94%). Trial procedures were acceptable with minimal missing data. Individual randomisation was feasible. The intervention was acceptable, with good fidelity and modest delivery costs (£307/patient). 96% of participants identified at least one goal, mostly exercise-related (73%). We found significantly better functioning (Barthel Index; +1.68, p=0.004), grip strength (+6.48kg, p=0.02), reduced psychological distress (GHQ-12; -3.92, p=0.01) and increased capability-adjusted life years (+0.017; 95% CI 0.001 to 0.031) at 6 months compared to TAU, with no differences in other outcomes. NHS and carer-support costs were variable, but overall lower in the intervention arm. The main limitation was difficulty maintaining outcome assessor blinding.
Conclusions: Evidence is lacking to inform frailty prevention service design, with no large-scale trials of multi-domain interventions. From stakeholder/public perspectives, new frailty prevention services should be personalised and encompass multiple domains, particularly socialising and mobility, and can be delivered by trained non-specialists. 
Our multi-component health promotion intervention was acceptable and delivered at modest cost. Our small study shows promise for improving clinical outcomes, including functioning and independence. A full-scale individually randomised RCT is feasible.
Next steps: A large, definitive RCT of the HomeHealth service is warranted.

Home-based health promotion for older people with mild frailty (HomeHealth): intervention development and feasibility Randomised Controlled Trial

Complex interventions are interventions or new healthcare technologies with many interacting components. Although most clinical trials could arguably be characterised as complex, the key distinguishing feature of complex interventions is that they involve the evaluation of multiple, potentially interacting components of an intervention, some of which may be challenging to measure or to systematically control. The challenge for evaluating complex interventions is then to design an evaluation that accounts for these different, interacting levels of care and their related social, environmental and individual factors so that one can tease out if the intervention is effective. This chapter provides guidance to researchers and health economists involved in the design and conduct of evaluations of complex interventions in end-of-life care.

Rachael Hunter

Papers

Pitfalls of adjusting for mean baseline utilities/costs in trial-based cost-effectiveness analysis with missing data

LiGHT: Laser in Glaucoma and Ocular Hypertension Trial – Methodology and Baseline characteristics of a multicentre randomised controlled trial.

ANTLER statistical analysis plan, Version 3, 16 January 2020

Home-based health promotion for older people with mild frailty (HomeHealth): intervention development and feasibility Randomised Controlled Trial

The Role of the Health Economist in the Evaluation and Development of Complex Interventions in End-of-Life Care