Health beliefs - what role do they play in outcomes research?

Lay beliefs about health and illness are individual and social, influenced by prevailing social and medical ideologies. Health beliefs clearly influence self-care motivation and have an effect on health-promoting behaviour (e.g. attendance at a screening program, food choices, adherence to prescribed medication). Further, the beliefs and attributions that people hold can directly affect physiological systems (e.g. the immune system). Health beliefs have been shown to influence a variety of patient-reported outcomes, including medication adherence, satisfaction and health-related quality of life. It is widely acknowledged that when the patient's beliefs are acknowledged and incorporated, rather than ignored, optimal biomedical patient-reported outcomes are more likely to be achieved. Several psychological models have been developed to predict health behaviours and may be utilised to identify the beliefs that inform such behaviours. These models consider the social milieu, personality, demographic, political and economic predictors of health beliefs. They demonstrate the impact of beliefs such as the causes of illness, effectiveness of healthcare and acceptability of health services, and how manipulating these can result in actual or intended behaviour change. This workshop will introduce health beliefs and discuss the psychological models that underpin the translation of belief into behaviour. The session is interactive, with participants defining health beliefs and their impact on behaviour. Participants will be invited to critique the models and apply their chosen model to a health indication of their choice.

Missing Data - implications for outcomes research and strategies to maximise data integrity

he workshop will firstly provide an overview of the problems associated with missing data within the context of clinical trials and how to minimise these. Missing data will be explored by modeling the impact on a number of datasets. This approach will be invaluable in highlighting how alternative methods for controlling for missing data impact differentially on the interpretation of study findings. Popular strategies involve options based on an assessment of the percentage of missing data. More innovative approaches to the management of missing data (e.g. based upon reliability analyses) will be explored and evaluated and the role of the most popular methods of data management explored in several study designs beyond those of the classic randomised controlled trial. Participants will have the opportunity to appraise and debate existing methods of missing data handling.

Initial medication adherence-review and recommendations for good practices in outcomes research: an ISPOR medication adherence and persistence special interest group report

Background: Positive associations between medication adherence and beneficial outcomes primarily come from studying filling/consumption behaviors after therapy initiation. Few studies have focused on what happens before initiation, the point from prescribing to dispensing of an initial prescription. Objective: Our objective was to provide guidance and encourage high-quality research on the relationship between beneficial outcomes and initial medication adherence (IMA), the rate initially prescribed medication is dispensed. Methods: Using generic adherence terms, an international research panel identified IMA publications from 1966 to 2014. Their data sources were classified as to whether the primary source reflected the perspective of a prescriber, patient, or pharmacist or a combined perspective. Terminology and methodological differences were documented among core (essential elements of presented and unpresented prescribing events and claimed and unclaimed dispensing events regardless of setting), supplemental (refined for accuracy), and contextual (setting-specific) design parameters. Recommendations were made to encourage and guide future research. Results: The 45 IMA studies identified used multiple terms for IMA and operationalized measurements differently. Primary data sources reflecting a prescriber's and pharmacist's perspective potentially misclassified core parameters more often with shorter/nonexistent pre- and postperiods (1-14 days) than did a combined perspective. Only a few studies addressed supplemental issues, and minimal contextual information was provided. Conclusions: General recommendations are to use IMA as the standard nomenclature, rigorously identify all data sources, and delineate all design parameters. Specific methodological recommendations include providing convincing evidence that initial prescribing and dispensing events are identified, supplemental parameters incorporating perspective and substitution biases are addressed, and contextual parameters are included.

Transition: improved literacy outcomes research study

This paper reports on the Transition: Improved Literacy Outcomes Research Study established by the Department of Education and Training (DET). The purpose of the study was to identify the most useful and usable data for educators to access in order to ensure that student literacy learning is maximised during the transition from Primary to Secondary school.1. The research followed a mixed-methods approach, combining a statistically defensible sample of schools selected to represent school types (primary, secondary, combined), locations (rural, regional, urban) and all regions with a survey and follow- up interviews.2. The results are presented as a mixture of statistics, case studies and discussion. The case studies were developed from both survey data and interview data.3. Leaders and teachers overwhelmingly valued teacher judgement (through AusVELS) as the most useful data in understanding students’ strengths and weaknesses, followed by On-Demand testing.4. NAPLAN results were frequently transferred between schools, but were found to be less useful than other data by teachers.5. School leaders and teachers are currently using data for ability streaming, or for tailoring curriculum for individual student needs. A number of schools use the Literacy data for achieving a balance of student abilities within classes.6. Support for access to, and use of, data is mainly manual, with some use of spreadsheets.7. As the number of feeder Primary schools to a single Secondary school increases, data management becomes a much larger burden on the Secondary staff concerned.8. In Secondary schools, there was a clear demand for Literacy data, but these data were not always those that were being provided by their feeder Priamary schools. This mis-match appears to lead to some frustration among Literacy transition staff at both levels of schooling.9. A gap that needs filling is around the nature of the pedagogies at the two school levels. Not knowing, or misunderstanding, the approaches and needs of each level of schooling leads to the passing on of irrelevant Literacy data in some instances.10. The need for a common template for transition data was expressed by many Transition staff, both Primary and Secondary. In some instances the secondary school had set up a local template for this11. It would be advantageous for data to be directly up-loaded or transferred into a system via electronic tools already in use, such as an Excel spreadsheet.12. We would recommend that the capacity to provide some visualisation of data, and the compilation of internal Literacy data such as teacher judgements and AusVELS levels, or additional testing carried out by the school.13. Student background data was seen by many Secondary transition staff as being equally as valuable as more formal Literacy data for determining student needs.

Patient outcomes in the acute revovery phase following robotic-assisted prostate surgery : a prospective study

Background: Robotic-assisted minimally invasive urologic surgery was developed to minimise surgical trauma resulting in quicker recovery. It has many potential benefits for patients with localised prostate cancer over traditional surgical techniques without taking a risk with the oncological result.

Objectives: To report the specific surgical outcomes for the first Australian cohort of patients with localised prostate cancer that had undergone robotic-assisted radical prostatectomy (RARP) surgery. The outcomes represent the acute (in-hospital) recovery phase and include pain, length of stay (LOS), urinary catheter management and wound management.

Methods: Prospective descriptive survey of 214 consecutive patients admitted to a large metropolitan private hospital in Melbourne, Australia between December 2003 and June 2005. Patients had undergone RARP surgery for localised prostate cancer. Data were collected from the medical records and through interview at the time of discharge. Descriptive statistics were used to describe the frequency and proportion of outcomes. Patient characteristics were tabulated using cross tabulation frequency distribution and measures of central tendency.

Results: The findings from this study are highly encouraging when compared to outcomes associated with traditional surgical techniques. Transurethral catheter duration (median 7 days (IQ range 2)) and LOS (median 3 days (IQ range 2)) were considerably reduced. While operation time (median 3.30 h (IQ range 1.07)) was marginally reduced we would expect a further reduction as the surgical team becomes more skilled.

Conclusion: The findings from this study contribute to building a comprehensive picture of patient outcomes in the acute (in-hospital) recovery phase for a cohort of Australian patients who have undergone RARP surgery for localised prostate cancer. As such, these findings will provide valuable information with which to plan care for patients’ who undergo robotic-assisted surgery.

Challenges in lifestyle and community interventions research

Earlier this year the BMC portfolio was enriched by a new journal BMC Obesity. Here, we present the aims and objectives of the section on Lifestyle and Community Interventions. Innovative research is needed. Preventing or managing obesity requires addressing different determinants across multiple levels where diverse levers and stakeholders can play a critical role. Interactions of these determinants within and between systems need to be studied. How to leverage, manage and measure this complexity underlies the innovation that is needed in the next generation of obesity interventions. The ambition of the Lifestyle and Community Interventions section is to provide a space for innovative research, including research that falls outside the traditional comfort zone. We welcome studies of heterogeneous designs, including those of qualitative, quantitative, mixed and systems methodologies. Studies of interest include not only outcomes research of interventions but also process evaluation, cost effectiveness or cost-benefit analysis, and implementation and dissemination research. Innovations that integrate diverse intervention levers or combine primary and secondary levels of prevention are particularly encouraged. The general aim of BMC Obesity’ s Lifestyle and Community Interventions section is to advance our ability to decide on what combinations of approaches will be required to effectively and equitably prevent obesity.

Quality of life related to oral versus subcutaneous iron chelation: a time trade-off study

Objective: To investigate the utility associated with subcutaneous infusion (deferoxamine) compared with once-daily oral administration (deferasirox) of iron chelation therapy.

Methods: Interviews using the time trade-off technique were used to estimate preferences (utility) for health states by finding the point at which respondents were indifferent between a longer but lower quality of life (QoL) and a shorter time in full health. Participants (n = 110) were community-based, 51% women, median age 35 years, from four regions in Sydney, Australia. Respondents rated three health states involving equal outcomes for people with thalassemia but with different treatment modalities for iron chelation; an "anchor state" describing a patient receiving iron chelation without administration mode specified, anchor state plus iron chelation via subcutaneous infusion, and anchor state plus iron chelation through once-daily oral medication.

Results: On an interval scale between 0 (death) and 1 (full health), median (interquartile range) utility of 0.80 (0.65–0.95) for the anchor state, 0.66 (0.45–0.87) for subcutaneous infusion, and 0.93 (0.80–0.97) for once-daily oral administration was obtained. The mean (median) difference of 0.23 (0.27) between the two treatments was statistically significant (Wilcoxon-signed rank test, P < 0.001). Subcutaneous infusion was associated with a mean (median) utility 0.13 (0.14) lower than the anchor state (P < 0.001), and once-daily oral treatment had a utility 0.10 (0.13) higher (P < 0.001).

Conclusion: Community respondents associate oral administration of an iron chelator such as deferasirox with enhanced QoL compared with subcutaneous treatment. Assuming equal safety and efficacy, QoL gains from once-daily oral treatment compared with subcutaneous infusion are significant.

Predicting time trade-off health state valuations of adolescents in four Pacific countries using the assessment of quality-of-life (AQoL-6D) instrument

Objectives: Pacific Obesity Prevention in Communities (OPIC) is a community-based intervention project targeting adolescent obesity in Australia, New Zealand, Fiji, and Tonga. The Assessment of Quality of Life Mark 2 (AQoL-6D) instrument was completed by 15,481 adolescents to obtain a description of the quality of life associated with adolescent overweight and obesity, and a corresponding utility score for use in a cost–utility analysis of the interventions. This article describes the recalibration of this utility instrument for adolescents in each country.

Methods: The recalibration was based on country-specific time trade-off (TTO) data for 30 multiattribute health states constructed from the AQoL-6D descriptive system. Senior secondary students, in a classroom setting, responded to 10 health state scenarios each. These TTO interviews were conducted for 24 groups, comprising 279 students in the four countries resulting in 2790 completed TTO scores. The TTO scores were econometrically transformed by regressing the TTO scores upon predicted scores from the AQoL-6D to produce country-specific algorithms. The latter incorporated country-specific “corrections” to the Australian adult utility weights in the original AQoL.

Results: This article reports two methodological elements not previously reported. The first is the econometric modification of an extant multi-attribute utility instrument to accommodate cultural and other group-specific differences in preferences. The second is the use of the TTO technique with adolescents in a classroom group setting. Significant differences in utility scores were found between the four countries.

Conclusion: Statistical results indicate that the AQoL-6D can be validly used in the economic evaluation of both the OPIC interventions and other adolescent programs.

Maximising clinical trial participation - how important is the social context?

Individuals participate in clinical research for a variety of reasons, dependant not only on the trial phase and their own clinical status but also their sense of optimism, altruism, clinician influence, or financial gain. Practical factors influencing participation may include geographical access, motivation, availability, and language spoken. Widely-used health psychology models (e.g the Theory of Reasoned Action, the Health Belief Model) demonstrate that, in addition to these factors, the primary reason for non-participation in clinical research is social perception of risk. These models detail how beliefs and attitudes toward clinical research develop within, and are influenced by, an individual's social context. Perceived social benefits and barriers toward participation are considered alongside perceived susceptibility and severity of side-effects from participation, or symptoms of disease. A major factor in such models is the subjective norm i.e. individuals' beliefs that important others expect or wish him/her to perform this behaviour, and the motivation to act in accordance with their expectations or wishes. This includes, but is not limited to, the role of the media, peers and family members, clarification of risk associated with trial participation and discussion of comparative risk, and risk equivalence between trials and same treatment outside trials.
The workshop will involve a 30 minute presentation from the discussion leaders and a 30 minute group-work session to explore how an understanding of the social context of participation in clinical research can maximise appropriate clinical trial participation.

Mathematics curriculum reform : reproducing social inequalities

This book is essential reading for Australasian mathematics educators and other researchers with an interest in the history of mathematics curriculum, the culture of mathematics, gender, and social justice issues in mathematics. Drawing on the results of research conducted by the Educational Outcomes Research Unit at the University of Melbourne and historical documents, Richard Teese argues that the education system fails to diffuse the economic and cultural benefits assumed to flow from the completion of secondary schooling.

The global burden of musculoskeletal conditions for 2010: an overview of methods.

The objective of this paper is to provide an overview of methods used for estimating the burden from musculoskeletal (MSK) conditions in the Global Burden of Diseases 2010 study. It should be read in conjunction with the disease-specific MSK papers published in Annals of Rheumatic Diseases. Burden estimates (disability-adjusted life years (DALYs)) were made for five specific MSK conditions: hip and/or knee osteoarthritis (OA), low back pain (LBP), rheumatoid arthritis (RA), gout and neck pain, and an 'other MSK conditions' category. For each condition, the main disabling sequelae were identified and disability weights (DW) were derived based on short lay descriptions. Mortality (years of life lost (YLLs)) was estimated for RA and the rest category of 'other MSK', which includes a wide range of conditions such as systemic lupus erythematosus, other autoimmune diseases and osteomyelitis. A series of systematic reviews were conducted to determine the prevalence, incidence, remission, duration and mortality risk of each condition. A Bayesian meta-regression method was used to pool available data and to predict prevalence values for regions with no or scarce data. The DWs were applied to prevalence values for 1990, 2005 and 2010 to derive years lived with disability. These were added to YLLs to quantify overall burden (DALYs) for each condition. To estimate the burden of MSK disease arising from risk factors, population attributable fractions were determined for bone mineral density as a risk factor for fractures, the occupational risk of LBP and elevated body mass index as a risk factor for LBP and OA. Burden of Disease studies provide pivotal guidance for governments when determining health priority areas and allocating resources. Rigorous methods were used to derive the increasing global burden of MSK conditions.