Clinical Research: Room for all?

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Identifying the communication activities of older people with aphasia: Evidence from naturalistic observation

Background: Increasingly there is a call from clinicians and researchers for measures that document the impact of aphasia on a person's everyday communication. Do existing assessments of communication disability adequately sample communication activities relevant to our clients? Communication skills and networks change with age. A need exists to determine the everyday communication activities of older people and in particular those with aphasia. Aims: The primary aim of this study was to describe and compare the everyday communication activities of older people with aphasia and healthy older people who are living in the community. A secondary aim was to investigate the content validity of the American Speech-Language Hearing Association Functional Assessment of Communication Skills for Adults (ASHA FACS, 1997) for older Australians. Methods & Procedures: Naturalistic observation was the method of choice for detailing the everyday communication of 15 older people with chronic aphasia following stroke and a matched group of 15 healthy older people who were living in the community. Researchers, in the role of participant observer, took field notes for 8 hours, over three occasions within a week. A total of 240 hours of observation have been coded in terms of communication activity, topic, communication partners, and place of communication. A brief 5-day diary served to check the representativeness of the observational data. After each hour of observation, the researcher checked which ASHA FACS items had been observed. Outcomes & Results: Naturalistic observation provided a rich, rigorous, and systematic methodology for detailing the dynamics and complexities of authentic communication. The most common communication activities for both groups were conversations at home and in social groups. Real-life communication was revealed to serve the dual purposes of transaction and interaction. Results indicate that older people with aphasia engage in similar communication activities to healthy older people although differences were evident in the frequency of communication and in specific activities such as story telling, writing, commenting, and acknowledging. ASHA FACS items were generally relevant to older Australians living in the community. Conclusions: This study demonstrated that communication activity is multifaceted in terms of the type of communication and contextual factors. The observational data describe the effects of aphasia on a person's everyday communication activity and reveal the impact of aphasia on the social functions of communication including sharing information, maintaining and establishing relationships, and telling one's story. Functional communication assessment requires a greater focus on the interactional and uniquely interpersonal aspects of social communication.

Core outcome domains for chronic pain clinical trials: IMMPACT recommendations

Objective. To provide recommendations for the core outcome domains that should be considered by investigators conducting clinical trials of the efficacy and effectiveness of treatments for chronic pain. Development of a core set of outcome domains would facilitate comparison and pooling of data, encourage more complete reporting of outcomes, simplify the preparation and review of research proposals and manuscripts, and allow clinicians to make informed decisions regarding the risks and benefits of treatment. Methods. Under the auspices of the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT), 27 specialists from academia. governmental agencies, and the pharmaceutical industry participated in a consensus meeting and identified core outcome domains that should be considered in clinical trials of treatments for chronic pain. Conclusions. There was a consensus that chronic pain clinical trials should assess outcomes representing six core domains: (1) pain, (2) physical functioning, (3) emotional functioning, (4) participant ratings of improvement and satisfaction with treatment, (5) symptoms and adverse events, (6) participant disposition (e.g. adherence to the treatment regimen and reasons for premature withdrawal from the trial). Although consideration should be given to the assessment of each of these domains, there may be exceptions to the general recommendation to include all of these domains in chronic pain trials. When this occurs, the rationale for not including domains should be provided. It is not the intention of these recommendations that assessment of the core domains should be considered a requirement for approval of product applications by regulatory agencies or that a treatment must demonstrate statistically significant effects for all of the relevant core domains to establish evidence of its efficacy. (C) 2003 International Association for the Study of Pain.

Outcome variables for osteoarthritis clinical trials: the OMERACT-OARSI set of responder criteria

Improvement in analysis and reporting results of osteoarthritis (OA) clinical trials has been recently obtained because of harmonization and standardization of the selection of outcome variables (OMERACT 3 and OARSI). Moreover, OARSI has recently proposed the OARSI responder criteria. This composite index permits presentation of results of symptom modifying clinical trials in OA based on individual patient responses (responder yes/no). The 2 organizations (OMERACT and OARSI) established. a task force aimed at evaluating: (1) the variability of observed placebo and active treatment effects using the OARSI responder criteria; and (2) the possibility of proposing a simplified set of criteria. The conclusions of the task force were presented and discussed during the OMERACT 6 conference, where a simplified set of responder criteria (OMERACT-OARSI set of criteria) was proposed.