Standardizing assessment of adverse effects in rheumatology clinical trials. Status of OMERACT Toxicity Working Group March 2000: Towards a common understanding of comparative toxicity/safety profiles for antirheumatic therapies

This paper describes the background and current status of an OMERACT facilitated effort to improve the consistency of adverse event reporting in rheumatology clinical trials, The overall goal is the development of an adverse event assessment tool that would provide a basis for use of common terminology and improve the consistency of reporting severity of side effects within rheumatology clinical trials and during postmarketing surveillance. The resulting Rheumatology Common Toxicity Criteria Index encompassed the following organ systems: allergic/immunologic, cardiac, ENT, gastrointestinal, musculoskeletal, neuropsychiatric, ophthalmologic, pulmonary and skin/integument. Before this tool is widely accepted, its validity, consistency, and feasibility need to be assessed in clinical trials.

The supportive care needs of men with prostate cancer (2000)

The diagnosis and subsequent treatment of prostate cancer is followed by a range of significant disease specific and iatrogenic sequelae. However, the supportive care needs of men with prostate cancer are not well described in the literature. The present study assesses the supportive care needs of men with prostate cancer who are members of prostate cancer self-help groups in Queensland, Australia. In all, 206 men aged between 48 and 85 years (mean = 68) completed the Supportive Care Needs Survey (SCNS) (62% response). The SCNS is a validated measure assessing perceived need in the domains of psychological needs, health system and information needs, physical and daily living needs, patient care and support, and sexuality. Items assessing need for access to services and resources were also included. One third of the sample reported a moderate to high need for help for multiple items in the sexuality, psychological and health system and information domains. Younger men reported greater need in the sexuality domain; living in major urban centres was predictive of greater psychological need; being closer to the time of diagnosis was related to greater need for help in the physical and daily living domain; having prostate cancer that is not in remission, having received radiation therapy, and lower levels of education were predictive of greater need for help in patient care and support. Of the total sample, 55% of men had used alternative cancer treatments in the past 12 months, with younger and more educated men more likely to use alternative therapies. Interventions in sexuality, psychological concerns and informational support are priorities for men with prostate cancer. Copyright (C) 2001 John Wiley & Sons, Ltd.

Marine and estuarine reservoir effects in central Queensland, Australia: Determination of Delta R values

As a component of archaeological investigations on the central Queensland coast, a series of five marine shell specimens live-collected between A.D. 1904 and A.D. 1929 and 11 shell/ charcoal paired samples from archaeological contexts were radiocarbon dated to determine local DeltaR values. The object of the study was to assess the potential influence of localized variation in marine reservoir effect in accurately determining the age of marine and estuarine shell from archaeological deposits in the area. Results indicate that the routinely applied DeltaR value of -5 +/- 35 for northeast Australia is erroneously calculated. The determined values suggest a minor revision to Reimer and Reimer's (2000) recommended value for northeast Australia from DeltaR = +11 +/- 5 to + 12 +/- 7, and specifically for central Queensland to DeltaR = +10 +/- 7, for near-shore open marine environments. In contrast, data obtained from estuarine shell/charcoal pairs demonstrate a general lack of consistency, suggesting estuary-specific patterns of variation in terrestrial carbon input and exchange with the open ocean. Preliminary data indicate that in some estuaries, at some time periods, a DeltaR value of more than - 155 +/- 55 may be appropriate, In estuarine contexts in central Queensland, a localized estuary-specific correction factor is recommended to account for geographical and temporal variation in C-14 activity. (C) 2002 Wiley Periodicals.

Auditor conservatism and voluntary disclosure: Evidence from the Year 2000 systems issue

This study further examines the phenomenon of conservative auditor behaviour by considering the level of voluntary disclosure of Year 2000 remediation information in company annual reports. Previous studies have provided evidence of conservative auditor behaviour by examining the link between Big 6 auditor choice and accruals (Francis and Krishnan 1999; Becker et al., 1998; Defond and Subramanyam 1998). Protecting their reputation capital increases Big 6 auditor incentives to act conservatively to avoid litigation risk. We propose and find that Big 6 auditor clients disclose more Year 2000 remediation information than non–Big 6 auditor clients.

Estimates of global mortality attributable to smoking in 2000

Background Smoking is a risk factor for several diseases and has been increasing in many developing countries. Our aim was to estimate global and regional mortality in 2000 caused by smoking, including an analysis of uncertainty. Methods Following the methods of Peto and colleagues, we used lung-cancer mortality as an indirect marker for accumulated smoking risk. Never-smoker lung-cancer mortality was estimated based on the household use of coal with poor ventilation. Relative risks were taken from the American Cancer Society Cancer Prevention Study, phase II, and the retrospective proportional mortality analysis of Liu and colleagues in China. Relative risks were corrected for confounding and extrapolation to other regions. Results We estimated that in 2000, 4.83 (uncertainty range 3.94-5.93) million premature deaths in the world were attributable to smoking; 2.41 (1.80-3.15) million in developing countries and 2.43 (2.13-2.78) million in industrialised countries. 3.84 million of these deaths were in men. The leading causes of death from smoking were cardiovascular diseases (1.69 million deaths), chronic obstructive pulmonary disease (0.97 million deaths), and lung cancer (0.85 million deaths). Interpretation Smoking was an important cause of global mortality in 2000. In view of the expected demographic and epidemiological transitions and current smoking patterns in the developing world, the health loss due to smoking will grow even larger unless effective interventions and policies that reduce smoking among men and prevent increases among women in developing countries are implemented.