Hospital outpatient responses to potential driving impairment due to prescribed medications

Driving and using prescription medicines that have the potential to impair driving is an emerging research area. To date it is characterised by a limited (although growing) number of studies and methodological complexities that make generalisations about impairment due to medications difficult. Consistent evidence has been found for the impairing effects of hypnotics, sedative antidepressants and antihistamines, and narcotic analgesics, although it has been estimated that as many as nine medication classes have the potential to impair driving (Alvarez & del Rio, 2000; Walsh, de Gier, Christopherson, & Verstraete, 2004). There is also evidence for increased negative effects related to concomitant use of other medications and alcohol (Movig et al., 2004; Pringle, Ahern, Heller, Gold, & Brown, 2005). Statistics on the high levels of Australian prescription medication use suggest that consumer awareness of driving impairment due to medicines should be examined. One web-based study has found a low level of awareness, knowledge and risk perceptions among Australian drivers about the impairing effects of various medications on driving (Mallick, Johnston, Goren, & Kennedy, 2007). The lack of awareness and knowledge brings into question the effectiveness of the existing countermeasures. In Australia these consist of the use of ancillary warning labels administered under mandatory regulation and professional guidelines, advice to patients, and the use of Consumer Medicines Information (CMI) with medications that are known to cause impairment. The responsibility for the use of the warnings and related counsel to patients primarily lies with the pharmacist when dispensing relevant medication. A review by the Therapeutic Goods Administration (TGA) noted that in practice, advice to patients may not occur and that CMI is not always available (TGA, 2002). Researchers have also found that patients' recall of verbal counsel is very low (Houts, Bachrach, Witmer, Tringali, Bucher, & Localio, 1998). With healthcare observed as increasingly being provided in outpatient conditions (Davis et al., 2006; Vingilis & MacDonald, 2000), establishing the effectiveness of the warning labels as a countermeasure is especially important. There have been recent international developments in medication categorisation systems and associated medication warning labels. In 2005, France implemented a four-tier medication categorisation and warning system to improve patients' and health professionals' awareness and knowledge of related road safety issues (AFSSAPS, 2005). This warning system uses a pictogram and indicates the level of potential impairment in relation to driving performance through the use of colour and advice on the recommended behaviour to adopt towards driving. The comparable Australian system does not indicate the severity level of potential effects, and does not provide specific guidelines on the attitude or actions that the individual should adopt towards driving. It is reliant upon the patient to be vigilant in self-monitoring effects, to understand the potential ways in which they may be affected and how serious these effects may be, and to adopt the appropriate protective actions. This thesis investigates the responses of a sample of Australian hospital outpatients who receive appropriate labelling and counselling advice about potential driving impairment due to prescribed medicines. It aims to provide baseline data on the understanding and use of relevant medications by a Queensland public hospital outpatient sample recruited through the hospital pharmacy. It includes an exploration and comparison of the effect of the Australian and French medication warning systems on medication user knowledge, attitudes, beliefs and behaviour, and explores whether there are areas in which the Australian system may be improved by including any beneficial elements of the French system. A total of 358 outpatients were surveyed, and a follow-up telephone survey was conducted with a subgroup of consenting participants who were taking at least one medication that required an ancillary warning label about driving impairment. A complementary study of 75 French hospital outpatients was also conducted to further investigate the performance of the warnings. Not surprisingly, medication use among the Australian outpatient sample was high. The ancillary warning labels required to appear on medications that can impair driving were prevalent. A subgroup of participants was identified as being potentially at-risk of driving impaired, based on their reported recent use of medications requiring an ancillary warning label and level of driving activity. The sample reported previous behaviour and held future intentions that were consistent with warning label advice and health protective action. Participants did not express a particular need for being advised by a health professional regarding fitness to drive in relation to their medication. However, it was also apparent from the analysis that the participants would be significantly more likely to follow advice from a doctor than a pharmacist. High levels of knowledge in terms of general principles about effects of alcohol, illicit drugs and combinations of substances, and related health and crash risks were revealed. This may reflect a sample specific effect. Emphasis is placed in the professional guidelines for hospital pharmacists that make it essential that advisory labels are applied to medicines where applicable and that warning advice is given to all patients on medication which may affect driving (SHPA, 2006, p. 221). The research program applied selected theoretical constructs from Schwarzer's (1992) Health Action Process Approach, which has extended constructs from existing health theories such as the Theory of Planned Behavior (Ajzen, 1991) to better account for the intention-behaviour gap often observed when predicting behaviour. This was undertaken to explore the utility of the constructs in understanding and predicting compliance intentions and behaviour with the mandatory medication warning about driving impairment. This investigation revealed that the theoretical constructs related to intention and planning to avoid driving if an effect from the medication was noticed were useful. Not all the theoretical model constructs that had been demonstrated to be significant predictors in previous research on different health behaviours were significant in the present analyses. Positive outcome expectancies from avoiding driving were found to be important influences on forming the intention to avoid driving if an effect due to medication was noticed. In turn, intention was found to be a significant predictor of planning. Other selected theoretical constructs failed to predict compliance with the Australian warning label advice. It is possible that the limited predictive power of a number of constructs including risk perceptions is due to the small sample size obtained at follow up on which the evaluation is based. Alternately, it is possible that the theoretical constructs failed to sufficiently account for issues of particular relevance to the driving situation. The responses of the Australian hospital outpatient sample towards the Australian and French medication warning labels, which differed according to visual characteristics and warning message, were examined. In addition, a complementary study with a sample of French hospital outpatients was undertaken in order to allow general comparisons concerning the performance of the warnings. While a large amount of research exists concerning warning effectiveness, there is little research that has specifically investigated medication warnings relating to driving impairment. General established principles concerning factors that have been demonstrated to enhance warning noticeability and behavioural compliance have been extrapolated and investigated in the present study. The extent to which there is a need for education and improved health messages on this issue was a core issue of investigation in this thesis. Among the Australian sample, the size of the warning label and text, and red colour were the most visually important characteristics. The pictogram used in the French labels was also rated highly, and was salient for a large proportion of the sample. According to the study of French hospital outpatients, the pictogram was perceived to be the most important visual characteristic. Overall, the findings suggest that the Australian approach of using a combination of visual characteristics was important for the majority of the sample but that the use of a pictogram could enhance effects. A high rate of warning recall was found overall and a further important finding was that higher warning label recall was associated with increased number of medication classes taken. These results suggest that increased vigilance and care are associated with the number of medications taken and the associated repetition of the warning message. Significantly higher levels of risk perception were found for the French Level 3 (highest severity) label compared with the comparable mandatory Australian ancillary Label 1 warning. Participants' intentions related to the warning labels indicated that they would be more cautious while taking potentially impairing medication displaying the French Level 3 label compared with the Australian Label 1. These are potentially important findings for the Australian context regarding the current driving impairment warnings about displayed on medication. The findings raise other important implications for the Australian labelling context. An underlying factor may be the differences in the wording of the warning messages that appear on the Australian and French labels. The French label explicitly states "do not drive" while the Australian label states "if affected, do not drive", and the difference in responses may reflect that less severity is perceived where the situation involves the consumer's self-assessment of their impairment. The differences in the assignment of responsibility by the Australian (the consumer assesses and decides) and French (the doctor assesses and decides) approaches for the decision to drive while taking medication raises the core question of who is most able to assess driving impairment due to medication: the consumer, or the health professional? There are pros and cons related to knowledge, expertise and practicalities with either option. However, if the safety of the consumer is the primary aim, then the trend towards stronger risk perceptions and more consistent and cautious behavioural intentions in relation to the French label suggests that this approach may be more beneficial for consumer safety. The observations from the follow-up survey, although based on a small sample size and descriptive in nature, revealed that just over half of the sample recalled seeing a warning label about driving impairment on at least one of their medications. The majority of these respondents reported compliance with the warning advice. However, the results indicated variation in responses concerning alcohol intake and modifying the dose of medication or driving habits so that they could continue to drive, which suggests that the warning advice may not be having the desired impact. The findings of this research have implications for current countermeasures in this area. These have included enhancing the role that prescribing doctors have in providing warnings and advice to patients about the impact that their medication can have on driving, increasing consumer perceptions of the authority of pharmacists on this issue, and the reinforcement of the warning message. More broadly, it is suggested that there would be benefit in a wider dissemination of research-based information on increased crash risk and systematic monitoring and publicity about the representation of medications in crashes resulting in injuries and fatalities. Suggestions for future research concern the continued investigation of the effects of medications and interactions with existing medical conditions and other substances on driving skills, effects of variations in warning label design, individual behaviours and characteristics (particularly among those groups who are dependent upon prescription medication) and validation of consumer self-assessment of impairment.

Were regulatory changes in reporting "abnormal items" justified? : evidence of intra-period classificatory earnings management practices in Australia

Purpose Managers generally have discretion in determining how components of earnings are presented in financial statements in distinguishing between ‘normal’ earnings and items classified as unusual, special, significant, exceptional or abnormal. Prior research has found that such intra-period classificatory choice is used as a form of earnings management. Prior to 2001, Australian accounting standards mandated that unusually large items of revenue and expense be classified as ‘abnormal items’ for financial reporting, but this classification was removed from accounting standards from 2001. This move by the regulators was partly in response to concerns that the abnormal classification was being used opportunistically to manage reported pre-abnormal earnings. This study extends the earnings management literature by examining the reporting of abnormal items for evidence of intra-period classificatory earnings management in the unique Australian setting. Design/methodology/approach This study investigates associations between reporting of abnormal items and incentives in the form of analyst following and the earnings benchmarks of analysts’ forecasts, earnings levels, and earnings changes, for a sample of Australian top-500 firms for the seven-year period from 1994 to 2000. Findings The findings suggest there are systematic differences between firms reporting abnormal items and those with no abnormal items. Results show evidence that, on average, firms shifted expense items from pre-abnormal earnings to bottom line net income through reclassification as abnormal losses. Originality/value These findings suggest that the standard setters were justified in removing the ‘abnormal’ classification from the accounting standard. However, it cannot be assumed that all firms acted opportunistically in the classification of items as abnormal. With the removal of the standardised classification of items outside normal operations as ‘abnormal’, firms lost the opportunity to use such disclosures as a signalling device, with the consequential effect of limiting the scope of effectively communicating information about the nature of items presented in financial reports.

Re-examining the evidence in radiation dermatitis management literature : an overview and a critical appraisal of systematic reviews

Purpose: To provide an overview and a critical appraisal of systematic reviews (SRs) of published interventions for the prevention/management of radiation dermatitis. Methods and Materials: We searched Medline, CINAHL, Embase, and the Cochrane Library. We also manually searched through individual reference lists of potentially eligible articles and a number of key journals in the topic area. Two authors screened all potential articles and included eligible SRs. Two authors critically appraised and extracted key findings from the included reviews using AMSTAR (the measurement tool for “assessment of multiple systematic reviews”). Results: Of 1837 potential titles, 6 SRs were included. A number of interventions have been reported to be potentially beneficial for managing radiation dermatitis. Interventions evaluated in these reviews included skin care advice, steroidal/nonsteroidal topical agents, systemic therapies, modes of radiation delivery, and dressings. However, all the included SRs reported that there is insufficient evidence supporting any single effective intervention. The methodological quality of the included studies varied, and methodological shortfalls in these reviews might create biases to the overall results or recommendations for clinical practice. Conclusions: An up-to-date high-quality SR in the prevention/management of radiation dermatitis is needed to guide practice and direction for future research. We recommend that clinicians or guideline developers critically evaluate the information of SRs in their decision making.

Two decades of exceptional achievements : does the evidence support nurses to favour Cochrane systematic reviews over other systematic reviews?

Systematic reviews (SRs) are increasingly recognised as the standard approach in summarising health research and influence clinical nursing practice and health care decisions (Coster and Norman, 2009, Grimshaw and Russell, 1993 and Griffiths and Norman, 2005). High quality SRs should have a clearly stated set of objectives with pre-defined eligibility criteria for studies; an explicit reproducible methodology; a systematic search that attempts to identify all studies that would meet the eligibility criteria; an assessment of the validity of the findings of the included studies; the assessment of risk of bias; and a systematic presentation and synthesis of the characteristics of findings of the included study (Higgins and Green, 2011). Although SRs are highly regarded and are expected to be rigorous, just as other research, their quality may vary (Choi et al., 2001 and Hoving et al., 2001)...

Victims Speak: Comparing Child Sexual Abusers and Their Victims Accounts of Offence Circumstances

This article presents findings from a longitudinal study. The research aimed to explore the effectiveness of a treatment program for offenders which lasted for three years. The research design was structured around the program with interviews and psychometric testing undertaken at key points in time with the same group of respondents. View all notes that sought to evaluate a treatment program for child sexual abusers. A triangulated methodological approach was adopted drawing upon quantitative and qualitative methodological techniques. The focus here is upon one element of this research. 2 2The quantitative element of this research will be published shortly but is referred to in the following reports Davidson 2000, 2003 [research funded by the National Probation Service]. Psychometric testing was undertaken over a four-year period with the men attending the treatment program to explore shifts in the extent of denial, blame attribution, and victim empathy over time. Offender cognitive distortions, general health, and self-esteem were also explored via psychometric testing. An interview-administered survey was undertaken with all sex offenders registered with the Probation Service (those on probation and in custody) in order to gather demographic data, and 117 of 150 offenders responded. View all notes Ninety-one in-depth interviews were conducted over a four-year period with a small, nonrandom sample of twenty-one male offenders who had been convicted of sexual offenses against children. All of the men were subject to probation orders with a psychiatric condition (Criminal Justice Act, 1991). One of the aims of this element of the research was to explore the extent to which evidence of denial could be found in offenders’ accounts of offense circumstance and also to explore the extent to which offenders minimized the nature and extent of abuse perpetrated. Offenders’ accounts of offense circumstances were compared to victim statements, and stark differences emerge. These findings have considerable implications for treatment practice with sex offenders, where victims’ perceptions could be used to directly confront offender denial and minimization.

Socio-environmental variability and Barmah Forest virus disease transmission : a review of epidemiological evidence and future prospects

Barmah Forest Virus (BFV) disease is the most rapidly emerging mosquito-borne disease in Australia. BFV transmission depends on factors such as climate, virus, vector and the human population. However, the impact of climatic and social factors on BFV remains to be determined. This paper provided an overview of current research and discusses the future research directions on the BFV transmission. These research findings could be regarded as an impetus towards BFV prevention and control strategies.

A Kallikrein 15 (KLK15) single nucleotide polymorphism located close to a novel exon shows evidence of association with poor ovarian cancer survival

KLK15 over-expression is reported to be a significant predictor of reduced progression-free survival and overall survival in ovarian cancer. Our aim was to analyse the KLK15 gene for putative functional single nucleotide polymorphisms (SNPs) and assess the association of these and KLK15 HapMap tag SNPs with ovarian cancer survival. Results In silico analysis was performed to identify KLK15 regulatory elements and to classify potentially functional SNPs in these regions. After SNP validation and identification by DNA sequencing of ovarian cancer cell lines and aggressive ovarian cancer patients, 9 SNPs were shortlisted and genotyped using the Sequenom iPLEX Mass Array platform in a cohort of Australian ovarian cancer patients (N = 319). In the Australian dataset we observed significantly worse survival for the KLK15 rs266851 SNP in a dominant model (Hazard Ratio (HR) 1.42, 95% CI 1.02-1.96). This association was observed in the same direction in two independent datasets, with a combined HR for the three studies of 1.16 (1.00-1.34). This SNP lies 15bp downstream of a novel exon and is predicted to be involved in mRNA splicing. The mutant allele is also predicted to abrogate an HSF-2 binding site. Conclusions We provide evidence of association for the SNP rs266851 with ovarian cancer survival. Our results provide the impetus for downstream functional assays and additional independent validation studies to assess the role of KLK15 regulatory SNPs and KLK15 isoforms with alternative intracellular functional roles in ovarian cancer survival.