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Biomedical subjects

David Barer

Publications and source records attributed to David Barer.

5 recordsLinked to original sources
PubMed2005

Design and analysis of phase III trials with ordered outcome scales: the concept of the sliding dichotomy.

The conventional approach to the analysis of a Phase III trial in head injury or stroke takes an ordered scale measuring functional outcome and collapses the scale to a binary outcome of favorable versus unfavorable. This discards potentially relevant information which limits statistical power and moreover is not in accord with clinical practice. We propose an alternative approach where a favorable outcome is defined as better than would be expected, taking account of each individual patient's baseline prognosis. This is illustrated through a worked example based on data from a Phase III trial in head injury. The approach is also compared with the proportional odds model, which is another statistical approach that can exploit an ordered outcome scale. The approach raises issues of clinical, statistical, and regulatory importance, and we initiate what we believe needs to become a widespread debate amongst the community involved in clinical research in head injury and stroke.

Clinical Trials, Phase III as Topic↗
PubMed2004

Progressing stroke: towards an internationally agreed definition.

BACKGROUND: The study of early neurological deterioration (progression) in acute stroke has been hampered by a lack of standardisation in the terminology or assessment procedures. An international panel was therefore convened, to agree on robust operational definitions for future studies and to validate them in an observational study involving 10 centres from the European Stroke Database Collaboration. METHODS: Standardised neurological assessments were performed daily for the first 3 days on patients with acute stroke, consecutively admitted within 24 h of onset, using the Scandinavian Stroke Scale (SSS) scoring system. An early deterioration episode (EDE) was defined as a >/=2 SSS-point worsening in either conscious level, arm, leg or eye movement scores, and/or a >/=3 SSS-point worsening in speech score, between consecutive neurological assessments. Stroke progression (SP) was defined as a similar neurological worsening comparing the day 3 assessment with the baseline assessment, or death occurring within 72 h of onset. The ability of SP to predict poor outcome (death or a Barthel ADL score <15/20 at 3 months), independently of initial stroke severity or other prognostic factors, was compared with possible alternative definitions, including one based on the Canadian Stroke Scale. RESULTS: The occurrence of EDEs and SP within the first 3 days of admission could be determined in 563 cases. EDEs occurred in 33% and SP in 26% of cases. Both were strong independent predictors of poor outcome. The prognostic efficiency of the European Progressing Stroke Study (EPSS) definition of SP was better than any of the alternatives examined, and clearly better than a definition based on changes in the total SSS score. CONCLUSIONS: The EPSS definitions of EDEs and SP have good construct and prognostic validity. They can be recommended as a standard for future studies on the aetiology and mechanisms of this common and important phenomenon.

Acute Disease↗
PubMed2002

Can staff attitudes to team working in stroke care be improved?

BACKGROUND: Teamwork is regarded as the cornerstone of rehabilitation. It is recognized that the skills of a multiprofessional team are required to provide the care and interventions necessary to maximize the patient's potential to recover from his/her stroke. LITERATURE REVIEW: Critical evaluation of team working is lacking in the literature. Indeed, there is no consensus on a precise definition of teamwork or on the best way of implementing it, beyond a general exhortation to members to work to the same therapeutic plan in a cohesive manner. The literature has highlighted many problems in team working, including petty jealousies, ignorance and a perceived loss of autonomy and threat to professional status. AIM: To determine if the use of team co-ordinated approaches to stroke care and rehabilitation would improve staff attitudes to team working. METHOD: A pre-post design was adopted using 'The Team Climate Inventory' to explore attitudes to team working before and after introducing the interventions. Local Research Ethics Committee approval was obtained. RESULTS: Improvements in attitudes towards team working suggest that the introduction of team co-ordinated approaches (integrated care pathways and team notes) did not result in greater team working. LIMITATIONS: The introduction of an integrated care pathway and team notes is based on an assumption that they would enhance team working. CONCLUSIONS: The results suggest that the introduction of team co-ordinated approaches (team notes and care pathways) do not improve attitudes to team working, teams appear to take a long time to establish cohesion and develop shared values.

Attitude of Health Personnel↗