Can a disease-specific education program augment self-management skills and improve Health-Related Quality of Life in people with hip or knee osteoarthritis?

Background: Patient education and self-management programs are offered in many countries to people with chronic conditions such as osteoarthritis (OA). The most well-known is the disease-specific Stanford Arthritis Self-Management Program (ASMP). While Australian and international clinical guidelines promote the concept of self-management for OA, there is currently little evidence to support the use of the ASMP. Several meta-analyses have reported that arthritis self-management programs had minimal or no effect on reducing pain and disability. However, previous studies have had methodological shortcomings including the use of outcome measures which do not accurately reflect program goals. Additionally, limited cost-effectiveness analyses have been undertaken and the cost-utility of the program has not been explored.

Methods/design: This study is a randomised controlled trial to determine the efficacy (in terms of Health-Related Quality of Life and self-management skills) and cost-utility of a 6-week group-based Stanford ASMP for people with hip or knee OA.

Six hundred participants referred to an orthopaedic surgeon or rheumatologist for hip or knee OA will be recruited from outpatient clinics at 2 public hospitals and community-based private practices within 2 private hospital settings in Victoria, Australia. Participants must be 18 years or over, fluent in English and able to attend ASMP sessions. Exclusion criteria include cognitive dysfunction, previous participation in self-management programs and placement on a waiting list for joint replacement surgery or scheduled joint replacement.

Eligible, consenting participants will be randomised to an intervention group (who receive the ASMP and an arthritis self-management book) or a control group (who receive the book only). Follow-up will be at 6 weeks, 3 months and 12 months using standardised self-report measures. The primary outcome is Health-Related Quality of Life at 12 months, measured using the Assessment of Quality of Life instrument. Secondary outcome measures include the Health Education Impact Questionnaire, Western Ontario and McMaster Universities Osteoarthritis Index (pain subscale and total scores), Kessler Psychological Distress Scale and the Hip and Knee Multi-Attribute Priority Tool. Cost-utility analyses will be undertaken using administrative records and self-report data. A subgroup of 100 participants will undergo qualitative interviews to explore the broader potential impacts of the ASMP.

Discussion: Using an innovative design combining both quantitative and qualitative components, this project will provide high quality data to facilitate evidence-based recommendations regarding the ASMP.

Focusing in on structural genomics : the University of Queensland structural biology pipeline

The flood of new genomic sequence information together with technological innovations in protein structure determination have led to worldwide structural genomics (SG) initiatives. The goals of SG initiatives are to accelerate the process of protein structure determination, to fill in protein fold space and to provide information about the function of uncharacterized proteins. In the long-term, these outcomes are likely to impact on medical biotechnology and drug discovery, leading to a better understanding of disease as well as the development of new therapeutics. Here we describe the high throughput pipeline established at the University of Queensland in Australia. In this focused pipeline, the targets for structure determination are proteins that are expressed in mouse macrophage cells and that are inferred to have a role in innate immunity. The aim is to characterize the molecular structure and the biochemical and cellular function of these targets by using a parallel processing pipeline. The pipeline is designed to work with tens to hundreds of target gene products and comprises target selection, cloning, expression, purification, crystallization and structure determination. The structures from this pipeline will provide insights into the function of previously uncharacterized macrophage proteins and could lead to the validation of new drug targets for chronic obstructive pulmonary disease and arthritis.

Guideline for the non-surgical management of hip and knee osteoarthritis

Introduction: Chronic disease is a major public health burden on Australian society. An increasing proportion of the population has risk factors for, or at least one, chronic disease, leading to increasing public health costs. Health service policy and delivery must not only address acute conditions, it must also effectively respond to the wide range of health and public service requirements of people with chronic illness.^1,2 Strong primary health care policy is an important foundation for a successful national health delivery system and long term management of public health, and is linked to practical outcomes including lower mortality, decreased hospitalisation and improved health outcomes.¹ National strategic health policy has recently given increased recognition to the importance of chronic disease management, with the Australian Federal Government endorsement of a number of initiatives for the prevention (or delay in onset), early detection and evidence based management of chronic disease, including osteoarthritis.^1,3
Chronic musculoskeletal conditions, including arthritis, account for over 4% of the national disease burden in terms of disability adjusted life years. Over 6 million Australians (almost one-third of the population) are estimated to have a chronic musculoskeletal disease; chronic musculoskeletal disease represents the main cause of long term pain and physical disability. In Australia, osteoarthritis is self reported by more than 1.4 million people (7.3% of the population4) and is the tenth most commonly managed problem in general practice.5 This number is set to rise as the elderly population grows. Osteoarthritis exerts a significant burden on the individual and the community through reduction in quality of life, diminished employment capacity and an increase in health care costs. For further details, refer to the Evidence to support the National Action Plan for Osteoarthritis, Rheumatoid Arthritis and Osteoporosis: Opportunities to improve health-related quality of life and reduce the burden of disease and disability (2004).⁶
As such, federal government health policy has identified arthritis as a National Health Priority Area and adopted a number of initiatives aimed at decreasing the burden of chronic disease and disability; raising awareness of preventive disease factors; providing access to evidence based knowledge; and improving the overall management of arthritis within the community.4 In 2002, all Australian health ministers designated arthritis and musculoskeletal conditions as Australia’s seventh National Health Priority Area. In response, a National Action Plan was developed in 2004 by the National Arthritis and Musculoskeletal Conditions Advisory Group (NAMSCAG).6 The aim of this document was to provide a blueprint for national initiatives to improve the health related quality of life of people living with osteoarthritis, rheumatoid arthritis and osteoporosis; reduce the cost and prevalence of these conditions; and reduce the impact on individuals, their carers and their communities within Australia. The National Action Plan was developed to complement both the National Chronic Disease Strategy – which is broader – and the National Service Improvement Framework for Osteoarthritis, Rheumatoid Arthritis and Osteoporosis, in addition to other national and state/ territory structures.

Reaching and influencing consumers in the prescription medicine market

Purpose – Celebrex became the first of a new class of drugs known as COX-2 selective non-steroidal anti-inflammatory drugs. It improves treatment for arthritis sufferers without compromising the protective lining of the stomach. The purpose of this paper is to illustrate how direct-to-consumer advertising (DTCA) of prescription medicines can be used to rebuild faith in the cyclooxygenase-2 (COX-2) product category.

Design/methodology/approach – The case is developed using published sources and no input is required from company representatives. The presentation style follows the classic comprehensive case format used in postgraduate teaching programmes.

Findings – Business executives and strategic marketing students would benefit from a discussion on how external environmental factors can suddenly impose a review of marketing strategy. The reader learns how management addresses the business dilemma using DTCA.

Research limitations/implications – A blockbuster rival drug Vioxx is withdrawn due to cardiovascular (CV) health safety concerns. A resulting dominant market situation soon becomes a business dilemma. The Federal Drug Administration calls for a “black box” warning label on Celebrex, the most serious type of warning.

Practical implications – The implications are that having a product in a class of its own is not enough. It highlights the need to communicate to different audiences, to both the medical profession and the end-user. Getting doctors to recommend the medicine and pulling the product through the channel by stimulating patient demand after a health scare are paramount.

Originality/value – This is the first pharmaceutical business case where the withdrawal of a rival product leaves the dominant competitor in a monopoly situation. Contrary to expectation, market share plummets despite the absence of competition.

Expanding evidence for the multiple dangers of epidemic abdominal obesity

The waistline of America has been expanding now for decades,1 largely as a consequence of an obesogenic environment, with a car-worshipping culture and take-away lifestyle par excellence.2 No upper limit to the prevalence or extent of obesity is yet apparent, and many countries and communities worldwide are busily following the American lead. Accumulating research evidence suggests that the personal and economic costs of the obesity epidemic are immense,3 driven by the obesity-related increases in risk for conditions such as type 2 diabetes mellitus, the metabolic syndrome, cardiovascular disease (CVD), kidney disease, arthritis, cancer, asthma, and sleep-disordered breathing. In addition, decreases are apparent in self-esteem and quality of life.

Stakeholder satisfaction with the Australian Rheumatology Association Database (ARAD)

Background: The Australian Rheumatology Association Database (ARAD) is a voluntary national registry for monitoring the long-term benefits and safety of biological disease-modifying anti-rheumatic drugs (bDMARDs) for inflammatory arthritis. Both rheumatologists and patients contribute data to the ARAD.

Objective: To evaluate the satisfaction of patients and rheumatologists with the ARAD.

Methods: Cross-sectional surveys were distributed to a random sample of 100 community-dwelling ARAD patients in 2007 and to rheumatologists attending the 2007 AustralianRheumatologyAssociation (ARA) annual scientific meeting.

Survey questions included items about the usefulness of the ARAD, workload for participants, frequency of questionnaires, and experience of contact with ARAD staff.

Results: A total of 92.5% of patients perceived the ARAD as very important (scoring 9-10 on a numeric rating scale). Patients reported minimal difficulty in completing questionnaires, and 95.0% indicated that a 6-month interval between questionnaires was reasonable. Of responding rheumatologists, 32.3%, 62.1%, and 53.8% indicated that the ARAD was very important (scoring 8-10) with respect to clinical information, research, and the profession, respectively, while 68% of those participating in the ARAD reported that the workload required to enroll patients was manageable and 30% found it difficult or onerous.

Conclusion: Key stakeholders in the ARAD view it as an important resource and are satisfied with its operations. Efforts will be directed towards assisting those rheumatologists who find the associated workload difficult and to improving the perceived clinical value of information available from the ARAD.

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.

Measuring worker productivity : frameworks and measures

Worker productivity is a combination of time off work (absenteeism) due to an illness and time at work but with reduced levels of productivity while at work (also known as presenteeism). Both can be gathered with a focus on application as a cost indicator and/or as an outcome state for intervention studies. We review the OMERACT worker productivity groups’ progress in evaluating measures of worker productivity for use in arthritis using the OMERACT filter. Attendees at OMERACT 9 strongly endorsed the importance of work as an outcome in arthritis. Consensus was reached (94% endorsement) for fielding a broader array of indicators of absenteeism. Twenty-one measures of at-work productivity loss, ranging from single item indicators to multidimensional scales, were reviewed for measurement properties. No set of at-work productivity measures was endorsed because of variability in the concepts captured, and the need for a better framework for the measurement of worker productivity that also incorporates contextual issues such as job demands and other paid and unpaid life responsibilities. Progress has been made in this area, revealing an ambivalent set of results that directed us back to the need to further define and then contextualize the measurement of worker productivity.

Improving the communication between care providers of individuals who may require joint replacement surgery (JRS) a framework for referral

Aims & rationale/Objectives : The objective of the project was to specify the information required in referrals to public hospital orthopaedic outpatient departments in order to streamline the care and prioritisation of individuals who may require JRS. It was envisaged that an evidence-based GP-Orthopaedic derived referral system would assist in ensuring that the right person accessed the right care at the right time.

Methods : In collaboration with the RACGP and the Commonwealth Department of Health and Ageing, a national stakeholder working group was convened. A scoping document was prepared with input from key stakeholders. A review of primary research was undertaken as well as a review of relevant guidelines. Information on the implementation and evaluation of similar programs in Australia and overseas also informed the referral specification.

Principal findings : The initial scoping processes with key stakeholders provided clear information on core components of the referral. These were the use of standardised and respected assessment tools to determine the severity of arthritis, fitness for surgery and willingness of affected individuals to undergo surgery.

Discussion : About 20,000 JRS occur each year in public hospitals which emanate from 5 to 10 fold number of referrals. Arthritis and musculoskeletal diseases are a national health priority area reflecting the high burden of disease associated with these conditions. Various initiatives are being undertaken to address the quality of life of affected individuals. This project has revealed areas of potential improvement in the communication between care providers of individuals who may need JRS.

Implications : The project will result in the development of a standard referral form and guidelines to assist referring practitioners to communicate more effectively with the multidisciplinary care team, in particular orthopaedic care providers. The guidelines will be piloted in a large rural setting.

Optimising care for people with chronic disease : foreword

Chronic disease self-management emerged as an organised, formal entity in Australia in the 1980s, when a specific group-based program was introduced from the United States. This program, the Stanford Arthritis Self-Management Course, was promulgated in Australia and other countries by its creator, Professor Kate Lorig of Stanford University. The program showed much early promise, particularly with its dissemination and uptake by an enthusiastic non-government sector. Over subsequent years it has matured, and many other programs endeavouring to support patients to engage in self-management have been developed. In some ways, chronic disease self-management has become mainstream.1-3

Recent advances on the roles of NO in cancer and chronic inflammatory disorders

Nitric oxide (NO) is a short-life molecule produced by the enzyme known as the nitric oxide synthase (NOS), in a reaction that converts arginine and oxygen into citrulline and NO. There are three isoforms of the enzyme: neuronal NOS (nNOS, also called NOS1), inducible NOS (iNOS or NOS2), and endothelial NOS (eNOS or NOS3). It is now known that each of these isoforms may be expressed in a variety of tissues and cell types. This paper is a review of the current knowledge of various functions of NO in diseases. We discuss in more detail its role in Cancer, the role of NO in myocardial pathophysiology, in central nervous system (CNS) pathologies. Other diseases such as inflammation, asthma, in chronic liver diseases, inflammatory bowel disease (IBD), arthritis, are also discussed. This review also covers the role of NO in cardiovascular, central nervous, pancreas, lung, gut, kidney, myoskeletal and chronic liver diseases (CLD). The ubiquitous role that the simple gas nitric oxide plays in the body, from maintaining vascular homeostasis and fighting infections to acting as a neurotransmitter and its role in cancer, has spurred a lot of interest among researchers all over the world. Nitric oxide plays an important role in the physiologic modulation of coronary artery tone and myocardial function. Nitric oxide from iNOS appears to be a key mediator of such glial-induced neuronal death. The high sensitivity of neurons to NO is partly due to NO causing inhibition of respiration, rapid glutamate release from both astrocytes and neurons, and subsequent excitotoxic death of the neurons.

Adults with arthritic conditions and care-seeking in an attachment framework

This thesis investigated the role of care-seeking amongst adults with arthritis, using an attachment framework to help explain the inconsistent results of previous studies in regard to psychological adjustment to a chronic illness. The results highlight the importance of attachment processes in partially influencing care-seeking and coping strategies that shape psychological adjustment. The portfolio addresses the frequent co-occurence of depression with chronic medical disorders. This impacts the ability for chronic, medically ill adults to engage in self-management strategies. Four case studies are presented.

Patient perspective : choosing or developing instruments

Previous Outcome Measures in Rheumatology (OMERACT) meetings recognized that patients view outcomes of intervention from a different perspective. This preconference position paper briefly sets out 2 patient-reported outcome (PRO) instrument approaches, the PROMISE computer adaptive testing (CAT) system and development of a rheumatoid arthritis-specific questionnaire to measure fatigue; a tentative proposal for a PRO instrument development pathway is also made.

Improving care for people with osteoarthritis of the hip and 'knee : how has national policy for osteoarthritis been translated into service models in Australia?

There is strong rationale for improving care for people with chronic conditions, including osteoarthritis (OA). Successful implementation of healthcare reform requires new concepts and directions that are strongly supported by policy, new models of care (service redesign) and changes in day-to-day practice (healthcare provider and patient practice). In this paper we discuss the extent to which policy about management of OA of the hip and knee has been translated into new service models in Australia. A structured search of government and other key health websites in Australia was performed to identify policy, funding initiatives and new services models for managing OA of the hip and knee. This search was supported by a literature review. Musculoskeletal conditions were designated a National Health Priority in Australia in 2002. Under the Better Arthritis and Osteoporosis Care initiative, Australia has developed a national policy for OA care and national evidence-based clinical practice guidelines for management of OA of the hip and knee. Only two well described examples of new chronic disease management service models, the Osteoarthritis Clinical Pathway (OACP) model and the Osteoarthritis Hip and Knee Service (OAHKS) were identified. Primarily focused within acute care public hospital settings, these have been shown to be feasible and acceptable but have limited data on clinical impact and cost-effectiveness. While policy is extant, implementation has not been systematic and comprehensive. Clinicians have evidence-based recommendations for OA management but are poorly supported by service models to deliver these effectively and efficiently.

Developing a placebo-controlled trial in surgery : issues of design, acceptability and feasibility

Background: Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK.
Methods: Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed).
Results: There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully.
Conclusions: Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this controversy, and the challenges that exist even when ethics committee approval has been granted. It showed that a placebo-controlled trial could be conducted in principle, albeit with difficulty. It also highlighted that not only does a placebo-controlled trial in surgery have to be ethically and scientifically acceptable but that it also must be a feasible course of action. The place of placebo-controlled surgical trials more generally is likely to be limited and require specific circumstances to be met. Suggested criteria are presented.