Pharmaceutical ecomonics and politics vs. patient safety : Lumiracoxib in Australia

Lumiracoxib (Prexige©) 200 mg was listed in Australia’s Pharmaceutical Benefits Scheme (PBS) schedules on 01 August 2006. The listing was intended as a cost-minimisation strategy, as lumiracoxib 200 mg was deemed equivalent in therapeutic effect to celecoxib (Celebrex©) 200 mg, and was available at a lower cost. By the time of listing on the PBS, a safety re-evaluation of the recommended daily dose of lumiracoxib was being considered in other national regulatory jurisdictions. Within 3 months of listing, the manufacturer revised the recommended dosage to half that of the PBS-listed dosage. However, the PBS listing was neither revoked nor modified. At the time of listing on the PBS, lumiracoxib was known to be 17 times as biochemically selective in inhibiting the COX-2 isoform as celecoxib, and twice as selective as rofecoxib, already withdrawn for safety reasons. Safety concerns had already been raised about adverse hepatic outcomes on daily doses of lumiracoxib 200 mg. Communication of information about the risk potential of lumiracoxib was inadequate. Economic and political considerations were prioritised over patient safety, and lumiracoxib 200 mg remained available via the PBS until 10 August 2007, when it was withdrawn for safety reasons following cases of hepatic morbidity and mortality.

Examining communication and team performance during clinical handover in a complex environment : the private sector post-anaesthetic care unit

* Threats to patient safety during clinical handover have been identified as an ongoing problem in health care delivery.

* In complex handover situations, organisational, cultural, behavioural and environmental factors associated with team performance can affect patient safety by undermining the stability of team functioning and the effectiveness of interprofessional communication.

* We present a practical framework for promoting systematic, comprehensive measurement of the factors involved in clinical handover.

* The framework can be used to develop viable solutions to the problems of clinical handover.

* The framework was devised and used in a recent project examining interprofessional communication and team performance during clinical handover in post-anaesthetic care units.

* The framework combines five key concepts: clinical governance, clinician engagement, ecological validity, safety culture and team climate, and sustainability.

* We believe that use of this framework will help overcome the limitations of previous research that has not taken into account the complex and multifaceted influences on clinical handover and interprofessional communication.

Doctoral research and scholarly communication : candidates, supervisors and information literacy

This study investigates information literacy and scholarly communication within the processes of doctoral research and supervision at a distance. Both doctoral candidates and supervisors acknowledge information literacy deficiencies and it is suggested that disintermediation and the proliferation of information may contribute to those deficiencies. Further to this, the influence of pedagogic continuity—particularly in relation to the information seeking behaviour of candidates—is investigated, as is the concomitant aspect of how doctoral researchers practise scholarly communication. The well-documented and enduring problem for candidates of isolation from the research cultures of their universities is also scrutinised. The contentious issue of more formally involving librarians in the doctoral process is also considered, from the perspective of candidates and supervisors. Superimposed upon these topical and timely issues is the theoretical framework of adult learning theory, in particular the tenets of andragogy. The pedagogical-andragogical orientation of candidates and supervisors is established, demonstrating both the differences and similarities between candidates and supervisors, as are a number of independent variables, including a comparison of on-campus and off-campus candidates. Other independent variables include age, gender, DETYA (Department of Education, Training & Youth Affairs) category, enrolment type, stage of candidature, employment and status, type of doctorate, and English/non-English speaking background. The research methodology uses qualitative and quantitative techniques encompassing both data and methodological triangulation. The study uses two sets of questionnaires and a series of in-depth interviews with a sample of on-campus and off-campus doctoral candidates and supervisors from four Australian universities. Major findings include NESB candidates being more pedagogical than their ESB counterparts, and candidates and supervisors from the Sciences are more pedagogical than those from Arts, Humanities and Social Sciences, or Education. Candidates make a transition from a more dependent and pedagogically oriented approach to learning towards more of an independent and andragogical orientation over the duration of their candidature. However, over tune both on-campus and off-campus candidates become more isolated from the research cultures of their universities, and less happy with support received from their supervisors in relation to their literature reviews. Ill The study found large discrepancies in perception between the support supervisors believed they gave to candidates in relation to the literature review, and the support candidates believed they received. Information seeking becomes easier over time, but candidates face a dilemma with the proliferation of information, suggesting that disintermediation has exacerbated the challenges of evaluation and organisation of information. The concept of pedagogic continuity was recognised by supervisors and especially candidates, both negative and positive influences. The findings are critically analysed and synthesised using the metaphor of a scholarly 'Club' of which obtaining a doctorate is a rite of passage. Recommendations are made for changes in professional practice, and topics that may warrant further research are suggested.

Patient assessment of medication information leaflets and validation of the Evaluative Linguistic Framework (ELF)

Objective : To obtain patient feedback about the structure and quality of medication information leaflets and validate the usefulness of the Evaluative Linguistic Framework (ELF) for improving written communication with patients.
Methods : Triangulated feedback about a set of rheumatoid arthritis (RA) medication leaflets, some developed with knowledge of the ELF, was obtained from 27 people with RA from interviews, focus group discussion and self-administered questionnaires. The principal elements of the framework were investigated: overall generic structure and functions of each stage, interpersonal relationship between writer and reader, technicality of language and density of information.
Results : Participant assessments of the leaflets aligned with the framework in terms of what constituted a good leaflet. While the main purpose of the leaflets was identified as being information provision, participants also wanted clear instructions, benefits to be highlighted and side effects to be comprehensively listed. For comprehensiveness and user-friendliness, leaflets developed with guidance of the ELF were consistently preferred.
Conclusion : According to people with RA, leaflets generated from a linguistic framework are clearer and more effective in communicating information about medications.
Practice Implications : The ELF is a user-friendly, structured analytic system that can assist with the development of effective high quality patient information materials.

Interpersonal features of talk in interpreted medical consultations

This linguistic study examined the interpersonal features of the talk between doctors and patients in consultations where a professional medical interpreter was required for them to communicate. Such features affect the relationship between doctor and patient and can impact on medical outcomes. The findings will assist interpreters and doctors in talking to patients and forms part of a larger project to develop a theory of medical interpreting.

A model for stakeholder interactions in hospitals : towards understanding the patient flow process

The aim of this research is to understand how stakeholder interactions can facilitate the patient flow process within a hospital. An analysis of the findings reveals that nurses are in a perfect position to be a conduit between doctors and managers. This is due to several factors including the nurses understanding of both the clinical and control worlds, as well as nurses ability to form networks based on their pivotal characteristics. As a result of these findings, a model for better understanding stakeholder relationships is developed. In this research, a mixed methods approach was used by undertaking a cultural assessment via survey questionnaire, complemented by observations of interactions between organisational actors, including formal semi-structured interviews and reflections of many hours of observation. Glouberman and Mintzberg’s four world’s models is used as a foundation for the arguments of this paper. Mitchell, Agle and Wood’s (1997) model is used to discuss the three stakeholder groups of this research including doctors, nurses, and managers.

Conceptualising health literacy from the patient perspective

Objective : A person's health literacy, i.e., their ability to seek, understand and use health information, is a critical determinant of whether they are able to actively participate in their healthcare. The objective of this study was to conceptualise health literacy from the patient perspective.

Methods : Using comprehensive qualitative methods 48 individuals were interviewed across three distinct groups in Australia: those with a chronic condition, the general community and individuals who had recently presented to a metropolitan public hospital emergency department. Purposeful sampling was employed to ensure a range of experiences was captured.

Results : Seven key abilities were identified: knowing when to seek health information; knowing where to seek health information; verbal communication skills; assertiveness; literacy skills; capacity to process and retain information; application skills.

Conclusion : This study identifies key abilities patients identified as critical to seek, understand and utilise information in the healthcare setting. These abilities are not reflected in existing measures for health literacy. Future measures of health literacy could consider incorporating abilities identified in this study and may provide guidance in developing health interventions to assist patients to participate effectively in their health.

Practice implications : More comprehensive measures to assess patient's health literacy are needed.

The place of information and communication technology-mediated consultations in primary care : GPs' perspectives

Background: New information and communication technologies such as email and text messaging have been shown to be useful in some aspects of primary care service delivery. Little is known about Scottish GPs’ attitudes towards the adoption of these technologies as routine consultation tools.

Objectives: To explore GPs’ perceptions of the potential place of new non-face-to-face consultation technologies in the routine delivery of primary care; to explore GPs’ perceived barriers to the introduction of these technologies and to identify the processes by which GPs feel that new consultation technologies could be incorporated into routine primary care.

Methods: Qualitative interview study: 20 in-depth semi-structured interviews carried out with maximum variation sample of GPs across Scotland.

Results: Whilst the face-to-face consultation was seen as central to much of the clinical and diagnostic work of primary care, many GPs were conditionally willing to consider using new technologies in the future, particularly to carry out administrative or less complex tasks and therefore maximize practice efficiency and patient convenience. Key considerations were access to appropriate training, IT support and medico-legal guidance.

Conclusions: GPs are conditionally willing to use new consultation media if clinically appropriate and if medico-legal and technical support is available.

Patient and practitioner compliance with silicone hydrogel and daily disposable lens replacement in the United States

Objective: The objectives of this study were to assess current recommendations for replacement frequency (RF) of silicone hydrogel (SH) and daily disposable (DD) lenses, to determine compliance with these recommendations, and to investigate the reasons given for noncompliance.

Methods: A package containing 20 patient surveys was sent to 309 eye care practitioners (ECPs) in the United States who had agreed to participate in the study. One thousand eight hundred fifty-nine completed surveys were received from 158 ECPs and 1,654 surveys were eligible for analysis. Questions related to patient demographics, lens type, lens wearing patterns, the ECP instructions for RF, and the actual patient reported RF. ECPs were asked to provide lens information and their recommendation for RF after the surveys had been completed and sealed in envelopes. All responses were anonymous.

Results: Sixty-six percent of patients were women and their mean age was 34 ± 12 years. Eighty-eight percent of lenses were worn for daily wear, 12.8 ± 3.2 hours a day, 6.2 ± 1.5 days a week. Lens type distribution was 16% DD, 45% 2 week (2W) SH, and 39% 1 month (1M) SH. ECP recommendations for RF varied according to the lens type; 1% of 1M (95% CI 0.2-1.7), 4% of DD (95% CI 2.1-7.2), and 18% of 2W (95% CI 15.1-20.7) patients were given instructions that did not conform to the manufacturers' recommended RF (MRRF). When considering only those patients who were given the correct instructions for RF, 38% were not compliant with the MRRF; noncompliance rates varied according to the lens type and were 12% for DD (95% CI 8.6-17.2), 28% for 1M (95% CI 24.9-32.1), and 52% for 2W (95% CI 47.8-55.8). The most frequent reasons for over wearing lenses were forgetting which day to replace lenses (51%) and to save money (26%). Fifty-three percent believed that a reminder system would aid compliance; the most popular methods being a cell phone reminder or text message (29%) and a nominated day each week or month (26%). Discussions between the ECPs and the patients were more extensive for patients who were compliant with the MRRF.

Conclusions: ECPs recommended RFs more frequently with DD and 1M SH lenses than with 2W SH lenses, consistent with manufacturers' recommendations. Patients were less compliant with RF than ECPs for all lens types investigated. Patients were most compliant with RF when wearing DD lenses and least compliant when wearing 2W SH lenses. Better communication facilitated greater compliance with RF. More than half of those not replacing lenses, when recommended, reported that this was because they forgot which day to replace their lenses.

Patient and practitioner compliance with silicone hydrogel and daily disposable lens replacement in Canada

Purpose: To assess current recommendations by optometrists for replacement frequency (RF) of silicone hydrogels (SH) and daily disposable (DD) contact lenses in Canada, determine rates of non-compliance with recommendations by both the optometrist and patient, and investigate reasons for non-compliance.

Methods: Survey packages were sent to optometrists in Canada who had agreed to participate. Patients completed survey questions regarding demographics and contact lens wearing patterns, including recommended and actual contact lens RF. Optometrists were asked to provide lens information and their recommendation for RF. Fifty-eight optometrists returned 654 surveys, of which 578 were eligible for analysis.

Results: Seventy percent of patients were female with a median age of 32 years. Lens type distribution was 18% DD, 35% two-week SH, and 47% one-month SH. Six percent were worn for extended wear. Daily wear median wearing time was 12 hours/day, a median of five days/week for DD, seven days/week for SH (two-week and one-month). Optometrists’ recommendations were non-compliant with the manufacturers’ recommended RF for 6% of DD, 35% of two week, and 2% of one-month patients. Patients were non-compliant with recommendations from both the manufacturer and optometrist for 12% of DD, 43% of two-week, and 31% of one-month lens wearers. The most common reason for non-compliance was forgetting which day to replace lenses. Fifty-six percent thought a reminder system would help with compliance. A higher proportion of compliant patients followed the RF because of confidence in their optometrist.

Conclusions: Optometrists generally recommended RFs consistent with manufacturers’ recommendations for DD and one-month SH lenses but often recommended longer intervals for two-week SH lenses. Patients were most compliant when wearing DD lenses and least compliant when wearing two-week SH lenses. Communication between the patient and optometrists concerning the risks of non-compliance, or initiating a reminder system might improve compliance.

Motivational interviewing techniques : facilitating behaviour change in the general practice setting

Background: One of the biggest challenges that primary care practitioners face is helping people change longstanding behaviours that pose significant health risks.

Objective: To explore current understanding regarding how and why people change, and the potential role of motivational interviewing in facilitating behaviour change in the general practice setting.

Discussion: Research into health related behaviour change highlights the importance of motivation, ambivalence and resistance. Motivational interviewing is a counselling method that involves enhancing a patient's motivation to change by means of four guiding principles, represented by the acronym RULE: Resist the righting reflex; Understand the patient's own motivations; Listen with empathy; and Empower the patient. Recent meta-analyses show that motivational interviewing is effective for decreasing alcohol and drug use in adults and adolescents and evidence is accumulating in others areas of health including smoking cessation, reducing sexual risk behaviours, improving adherence to treatment and medication and diabetes management.

The impact structured patient assessment frameworks have on patient care: an integrative review

Aims and objectives:
To evaluate structured patient assessment frameworks' impact on patient care.

Background:
Accurate patient assessment is imperative to determine the status and needs of the patient and the delivery of appropriate patient care. Nurses must be highly skilled in conducting timely and accurate patient assessments to overcome environmental obstacles and deliver quality and safe patient care. A structured approach to patient assessment is widely accepted in everyday clinical practice, yet little is known about the impact structured patient assessment frameworks have on patient care.

Design:
Integrative review.

Methods:
An electronic database search was conducted using Cumulative Index to Nursing and Allied Health Literature, Medical Literature Analysis and Retrieval System, PubMed and ProQuest Dissertations and Theses. The reference sections of textbooks and journal articles on patient assessment were manually searched for further studies. A comprehensive peer review screening process was undertaken. Research studies were selected that evaluated the impact structured patient assessment frameworks have on patient care. Studies were included if frameworks were designed for use by paramedics, nurses or medical practitioners working in prehospital or acute in-hospital settings.

Results:
Twelve studies met the inclusion criteria. There were no studies that evaluate the impact of a generic nursing assessment framework on patient care. The use of a structured patient assessment framework improved clinician performance of patient assessment. Limited evidence was found to support other aspects of patient care including documentation, communication, care implementation, patient and clinician satisfaction, and patient outcomes.

Conclusion:
Structured patient assessment frameworks enhance clinician performance of patient assessment and hold the potential to improve patient care and outcomes; however, further research is required to address these evidence gaps, particularly in nursing.

Relevance to clinical practice:
Acute care clinicians should consider using structured patient assessment frameworks in clinical practice to enhance their performance of patient assessment.

Demonstrable professionalism : linking patient-centred care and revalidation

The move by the Medical Board of Australia to commence a conversation with the medical profession about revalidation reflects that patient-centred care is at the heart of good medical practice. Patients judge their doctors' commitment to them based on whether their individual interactions with doctors meet their needs. We argue that ensuring that doctors are continuing to perform at a level that the community regards as acceptable is a demonstration of an individual doctor's professionalism and thus their commitment to patient-centred care. This impacts on the profession as a whole, which needs to commit to what we call 'demonstrable professionalism' - the ongoing and active demonstration of performance that the community regards as acceptable. This needs to be supported by organisations in which doctors work, reflecting the importance of organisational context to clinical practice. Revalidation processes thus need both to reflect the work of doctors and be meaningful to the community. The move to consider revalidation of doctors by regulatory authorities should not be seen by the profession as a threat, but more as an opportunity to demonstrate the profession's commitment to patient-centred care

Implications for Australian anaesthetists and proceduralists of a recent court decision regarding informed consent and patient positioning

 This article discusses the medicolegal implications of a recent judgment in relation to a patient who suffered significant morbidity as a result of patient positioning during an operative procedure. The patient developed an unexpected serious complication following surgery, in the context of a preoperative consent that did not cover every potential complication or contingency. The court held that the failure to warn of a particular risk that would have prevented the patient from undergoing a procedure but did not occur will not necessarily result in a finding of negligence in relation to another risk where the harm did occur. This finding is well aligned to current clinical practice and at the same time does not abrogate the practitioner's duty to provide a comprehensive list of possible complications during the consent process for any proceduralist. In the context of a procedure requiring anaesthesia, the importance of communication and understanding between the anaesthetist and proceduralist as to which aspects of the consent process are undertaken by whom, and to ensure the process is done comprehensively, is of great importance and is indirectly highlighted by this recent judgment.