Using patients' experiences of adverse events to improve health service delivery and practice: protocol of a data linkage study of Australian adults age 45 and above

Evidence of patients' experiences is fundamental to creating effective health policy and service responses, yet is missing from our knowledge of adverse events. This protocol describes explorative research redressing this significant deficit; investigating the experiences of a large cohort of recently hospitalised patients aged 45 years and above in hospitals in New South Wales (NSW), Australia.

Children's memory of recurring events: is the first event always the best remembered?

Three experiments were conducted to examine the effect of age (4-5 and 6-8 years) and retention interval on children's ability to remember separate occurrences of a repeated event that varied in terms of content (items, dialog, etc.) Experiment 1 explored children's ability to recall the first versus last occurrence of a series of six events, at either one week or six weeks delay. Experiments 2 and 3 explored children's ability to identify the position of items in terms of their order of presentation within the series across two retention intervals. Overall, the results revealed clear age differences in children's performance. In general, the 6- to 8-year+old children performed better on all tasks than the 4- to 5-year-old children. Further, the older children showed relatively good memory of the first and last items compared to the middle items, although the last items were more likely to be forgotten or misplaced in the sequencing tasks over time that the first items. For the younger children, the patterns of results were sometimes but not always consistent with that of the older children The relevance and generalisability of these findings to the legal setting are discussed as well as directions for future research.

The limits of medicine and the social consequences for sufferers of chronic fatigue syndrome

Chronic fatigue syndrome (CFS) appears to be made up of several clusters of illness categories acting alone or in tandem to cause the decline of health through; fatigue/exhaustion, sensitivity/allergies, pain, general muscle and joint pains, cognitive impairment and gastrointestinal problems. This study investigated how patients interpret, evaluate and respond to the complex and varied symptoms of chronic fatigue syndrome. Data were collected from persons with CFS using a survey (n=90) and an interview (n=45). The researchers investigated how chronic fatigue syndrome is diagnosed by medical practitioners, how the label of CFS is determined and the social consequences for the patient. The results confirm the limited ability of the biomedical paradigm to diagnose adequately and treat effectively 'socially constructed' and medically ambiguous illnesses like CFS. In the absence of a legitimated regime of medical treatment for CFS, a range of often expensive treatments are employed by CFS sufferers, from formal use of pharmaceutical drugs through to 'alternative' therapies, including herbal, vitamin, homeopathic, esoteric meditative techniques, spiritual healing and general counselling are taken in no particular order.

Extensible detection and indexing of highlight events in broadcasted sports video

Content-based indexing is fundamental to support and sustain the ongoing growth of broadcasted sports video. The main challenge is to design extensible frameworks to detect and index highlight events. This paper presents: 1) A statistical-driven event detection approach that utilizes a minimum amount of manual knowledge and is based on a universal scope-of-detection and audio-visual features; 2) A semi-schema-based indexing that combines the benefits of schema-based modeling to ensure that the video indexes are valid at all time without manual checking, and schema-less modeling to allow several passes of instantiation in which additional elements can be declared. To demonstrate the performance of the events detection, a large dataset of sport videos with a total of around 15 hours including soccer, basketball and Australian football is used.

Power of darkness : narrative and biographical reflexivity in "A series of unfortunate events"

This paper investigates the high-earning children's series, A Series of Unfortunate Events, in relation to the skills young people require to survive and thrive in what Ulrich Beck calls risk society. Children's textual culture has been traditionally informed by assumptions about childhood happiness and the need to reassure young readers that the world is safe. The genre is consequently vexed by adult anxiety about children's exposure to certain kinds of knowledge. This paper discusses the implications of the representation of adversity in the Lemony Snicket series via its subversions of the conventions of children's fiction and metafictional strategies. Its central claim is that the self-consciousness or self-reflexivity of A Series of Unfortunate Events} models one of the forms of reflexivity children need to be resilient in the face of adversity and to empower them to undertake the biographical project risk society requires of them.

Quality of reporting of randomized clinical trials in abstracts of the 2005 annual meeting of the American College of Rheumatology.

Objective: To determine the quality of abstracts reporting randomized clinical trials (RCT) at the 2005 Annual Scientific Meeting of the American College of Rheumatology.

Methods: All 2005 abstracts including late-breaking abstracts were assessed. An abstract was deemed to be reporting an RCT if it indicated that participants were randomized in the title or body of the abstract. RCT were excluded if they included only pharmacokinetic data. The CONSORT checklist was applied and relevant data extracted. We defined manufacturer support as acknowledgment of industry support or industry employee as co-author.

Results: Of 2146 abstracts, 143 (6.7%) reported RCT. Of these, 78.3% were drug trials, and 63.6% indicated manufacturer support. Only 30.8% of abstracts used "randomized" in the title, 44.1% did not explicitly state whether blinding was undertaken, and only 7.0% clearly stated who was blinded. Thirty percent of studies did not give an explicit definition of eligibility criteria of participants. While 84.6% explicitly described the experimental intervention, only 37.1% explicitly described the comparator intervention. Only 21% explicitly stated that an intention to treat analysis was performed. Baseline demographic and clinical characteristics were reported in 48.3%. While most abstracts reported summary results for each treatment group, only 35.7% reported effect size with its precision.

Conclusion: The quality of reporting is suboptimal in many RCT abstracts. Abstracts reporting RCT would benefit from a structured approach that ensures more detailed reporting of eligibility criteria, active and comparator interventions, flow of participants, and adequate summary and precision of results.

Using clinical trial data and linked administrative health data to reduce the risk of adverse events associated with the uptake of newly released drugs by older Australians : a model process

Background
The study was undertaken to evaluate the contribution of a process which uses clinical trial data plus linked de-identified administrative health data to forecast potential risk of adverse events associated with the use of newly released drugs by older Australian patients.

Methods
The study uses publicly available data from the clinical trials of a newly released drug to ascertain which patient age groups, gender, comorbidities and co-medications were excluded in the trials. It then uses linked de-identified hospital morbidity and medications dispensing data to investigate the comorbidities and co-medications of patients who suffer from the target morbidity of the new drug and who are the likely target population for the drug. The clinical trial information and the linked morbidity and medication data are compared to assess which patient groups could potentially be at risk of an adverse event associated with use of the new drug.

Results
Applying the model in a retrospective real-world scenario identified that the majority of the sample group of Australian patients aged 65 years and over with the target morbidity of the newly released COX-2-selective NSAID rofecoxib also suffered from a major morbidity excluded in the trials of that drug, indicating a substantial potential risk of adverse events amongst those patients. This risk was borne out in post-release morbidity and mortality associated with use of that drug.

Conclusions
Clinical trial data and linked administrative health data can together support a prospective assessment of patient groups who could be at risk of an adverse event if they are prescribed a newly released drug in the context of their age, gender, comorbidities and/or co-medications. Communication of this independent risk information to prescribers has the potential to reduce adverse events in the period after the release of the new drug, which is when the risk is greatest.

Note: The terms 'adverse drug reaction' and 'adverse drug event' have come to be used interchangeably in the current literature. For consistency, the authors have chosen to use the wider term 'adverse drug event' (ADE).