The development and utility of a multicriteria patient decision aid for people contemplating treatment for osteoarthritis.

BACKGROUND: There are a range of treatment options for osteoarthritis (OA) of the knee and hip, each with a unique profile of risks and benefits. Patient decision aids can help incorporate patient preferences in treatment decision-making. The aim of this study was to develop and test the utility of a patient decision aid for OA that was developed using a multicriteria decision analytic framework. METHODS: People contemplating treatment for OA who had accessed the website myjointpain.org.au were invited to participate in the study by using the online patient decision aid. Two forms of the patient decision aid were created: A shorter form and a longer form, which allowed greater customization that was offered to respondents after they had completed the shorter form. Respondents also completed questions asking about their experience using the patient decision aid. RESULTS: A total of 625 self-selected respondents completed the short-form and 180 completed the long-form. Across both forms, serious side effects, pain and function were rated as the most important treatment outcomes. Most respondents (64%) who completed the longer form reported that using the tool was a positive experience, 38% reported that using the tool had changed their mind and 48% said that using the tool would improve the quality of their decision-making. CONCLUSIONS: Overall, the findings suggest that this patient decision aid may be of use to a substantial number of people in facilitating appropriate treatment decision-making. PATIENT OR PUBLIC CONTRIBUTION: Service users of myjointpain.org.au were involved through their participation in the study, and their feedback will guide the development of future iterations of the tool.

What Constitutes a Clear Margin in Patients With Locally Recurrent Rectal Cancer Undergoing Pelvic Exenteration?

OBJECTIVES: To determine what constitutes a clear resection margin (R0) in patients with LRRC. SUMMARY OF BACKGROUND DATA: R0 is the most important predictor of survival in patients with LRRC. However, it is not clear what constitutes an R0. A 1-2 mm margin is often used to define R0 but this is based on primary rectal cancer studies. The same definition of R0 is likely inappropriate considering the anatomy and etiology of local recurrences. METHODS: A prospective maintained database was reviewed. A R2 margin was defined as macroscopic residual disease. R1 was defined as a microscopically involved margin (0 mm margin) and R0 as at least a 0.1 mm margin. Associations between R status and local recurrence was explored using X2 test. Associations between margins and overall survival and local recurrence free survival were explored using Kaplan-Meier analysis. RESULTS: There were 210 patients eligible for inclusion for analysis. Of these, 165 (78.6%), 35 (16.7%), and 10 (4.8%) patients had R0, R1, and R2 margins, respectively. Overall survival was significantly different between patients with R0 versus R1 margins but wider resection margins do not confer a survival benefit [57 months (95% confidence interval 38.5-75.5) vs 33 months (95% confidence interval 20.3-45.7), P = 0.03]. Local recurrence free survival was significantly different between patients with R0 versus R1 margins (2- and 5-year local recurrence free survivals of 53.5% and 20.4% vs 25.9% and 14.8%, respectively, P = 0.001 for both). Margins >0.5 mm were not predictive of local recurrence free survival. CONCLUSIONS: A microscopically clear resection margin is most important in predicting overall survival. Margins up to 0.5 mm offers a local recurrence benefit but does not confer survival benefit.

A survey of Australian public attitudes towards funding of high cost cancer medicines.

BACKGROUND: In the past decade many novel, and in some cases transformative, cancer medicines have entered the market. Their prices and the amount spent on them by governments have increased rapidly, bringing to the forefront trade-offs that must be made. In this paper we explore the Australian public's attitude towards the funding of high cost cancer medicines (HCCM) to inform reimbursement and health technology assessment (HTA) policy. METHODS: A survey consisting of 49 questions about the funding of HCCMs was developed by the investigators. Recruitment was conducted via Qualtrics. 1039 Australian adults completed the survey. RESULTS: The Australian public overwhelmingly supports funding of HCCMs (95.5 %) to enhance equity of access (97.8 %), and to respond to patients' needs (98 %). When respondents were challenged to balance equity versus access in different contexts inconsistencies emerged. Different demographic factors were important in predicting support for various strategies. CONCLUSION: Our results suggest that the Australian public strongly supports government funding of HCCMs and values both equity and access. Equally, however, the public is uncertain about how equity and access are to be balanced and achieved, and such ambivalence needs to be both further explored and accommodated in policy processes. Our results may be used by policymakers in Australia, and countries with similar systems and values, to further develop policies and processes for funding HCCMs.

Atrial Fibrillation Screen, Management, and Guideline-Recommended Therapy in the Rural Primary Care Setting: A Cross-Sectional Study and Cost-Effectiveness Analysis of eHealth Tools to Support All Stages of Screening.

BACKGROUND Internationally, most atrial fibrillation (AF) management guidelines recommend opportunistic screening for AF in people ≥65 years of age and oral anticoagulant treatment for those at high stroke risk (CHA2DS2-VA≥2). However, gaps remain in screening and treatment. METHODS AND RESULTS General practitioners/nurses at practices in rural Australia (n=8) screened eligible patients (≥65 years of age without AF) using a smartphone ECG during practice visits. eHealth tools included electronic prompts, guideline-based electronic decision support, and regular data reports. Clinical audit tools extracted de-identified data. Results were compared with an earlier study in metropolitan practices (n=8) and nonrandomized control practices (n=69). Cost-effectiveness analysis compared population-based screening with no screening and included screening, treatment, and hospitalization costs for stroke and serious bleeding events. Patients (n=3103, 34%) were screened (mean age, 75.1±6.8 years; 47% men) and 36 (1.2%) new AF cases were confirmed (mean age, 77.0 years; 64% men; mean CHA2DS2-VA, 3.2). Oral anticoagulant treatment rates for patients with CHA2DS2-VA≥2 were 82% (screen detected) versus 74% (preexisting AF)(P=NS), similar to metropolitan and nonrandomized control practices. The incremental cost-effectiveness ratio for population-based screening was AU$16 578 per quality-adjusted life year gained and AU$84 383 per stroke prevented compared with no screening. National implementation would prevent 147 strokes per year. Increasing the proportion screened to 75% would prevent 177 additional strokes per year. CONCLUSIONS An AF screening program in rural practices, supported by eHealth tools, screened 34% of eligible patients and was cost-effective. Oral anticoagulant treatment rates were relatively high at baseline, trending upward during the study. Increasing the proportion screened would prevent many more strokes with minimal incremental cost-effectiveness ratio change. eHealth tools, including data reports, may be a valuable addition to future programs. REGISTRATION URL: https://www.anzctr.org.au. Unique identifier: ACTRN12618000004268.

Economic and clinical outcomes of the nurse practitioner-led Sydney Adventist Hospital Community Palliative Care Service.

Objective The aim of this study was to assess the clinical, economic and personal impacts of the nurse practitioner-led Sydney Adventist Hospital Community Palliative Care Service (SanCPCS) Methods Parallel economic analysis of usual care was conducted prospectively with patients from the enhanced SanCPCS. A convenient retrospective sample from the initial service was used to determine the impact of the enhanced service on patient care. A time series survey was used with patients and carers from within the expanded service group in order to measure patient outcomes and values as they approached death. Results Patients of the SanCPCS were less likely to die in hospital and had fewer hospital admissions. In addition, the service halved the estimated hospitalisation cost per patient, but the length of hospital stay was not affected by the service. The SanCPCS was more beneficial for women in terms of fewer hospital admissions and lower costs. Patients' choices regarding place of care and death and what was 'important' to them changed over time. For instance, patients tended to prefer being at home as they approached death, and being pain free doubled in importance. Conclusions Nurse practitioner-led community palliative care services have the potential to result in significant economic and personal benefits for patients and their families in need of such care. What is known about the topic? National trends show an emphasis on community services with the aim of promoting and supporting the choice of dying at home, and this coincides with drives to reduce hospital costs and length of stay. Community-based palliative care services may offer substantial economic and clinical benefits. What does this paper add? The SanCPCS was the first nurse practitioner-led community-based palliative care service in Australia. The expansion of this service led to significantly fewer admissions and deaths in hospital, and halved the estimated hospitalisation cost per patient. What are implications for practitioners? Nurse practitioner-led models for care in the out-patient or community setting are a logical direction for palliative services through the engagement of specialised providers uniquely trained to support, nurture, guide and educate patients and their carers.

Qualitative Evaluation of Evidence-Based Online Decision Aid and Resources for Osteoarthritis Management: Understanding Patient Perspectives.

OBJECTIVE: To qualitatively examine the experiences with, and impact of, evidence-based online resources in self-management among Australians with osteoarthritis. METHODS: Telephone interviews were conducted with 36 users of a novel osteoarthritis resource, the Osteoarthritis Awareness Hub. Rogers' 5 attributes of innovation (relative advantage, compatibility, complexity, trialability, and observability) and outcomes guided the semistructured interview and analysis. Maximum variation sampling was used, and data saturation occurred after 33 interviews. A coding scheme was agreed upon and all interview data were entered into NVivo for qualitative content analysis. RESULTS: Study participants had high levels of literacy and health literacy. For adoption and implementation of an innovation, the participants' narratives confirmed and underscored the fact that it was important that it come from an authoritative and trusting voice and that its perceived benefits align with participants' values and existing practices (relative advantage and compatibility). The participants also valued seeing the practical benefits of the innovation, such as its capacity to impart quality and balanced new insights and information, and to maintain and monitor their personal progress. Notably, many participants spoke about the mental and physical health benefits that they derived from engagement with the online resources. CONCLUSION: Our study findings confirm that web-based tools can be a useful adjunct to patients adopting self-management strategies. Rogers' theory provides a framework for a deeper appreciation of the how, why, and what questions concerning the adoption and implementation processes, especially among people with good technology and health literacy.

Community views on factors affecting medicines resource allocation: cross-sectional survey of 3080 adults in Australia.

Objective The aim of the present study was to determine Australian community views on factors that influence the distribution of health spending in relation to medicines. Methods A cross-sectional web-based survey was performed of 3080 adults aged ≥18 years. Participants were asked to rank, in order of importance, 12 criteria according to which medicines funding decisions may be made. Results Of all respondents, 1213 (39.4%) considered disease severity to be the most important prioritisation criterion for funding a new medicine. This was followed by medicines treating a disease affecting children (13.2%) and medicines for cancer patients (9.1%). Medicines targeting a disease for which there is no alternative treatment available received highest priority from 8.6% of respondents. The remaining eight prioritisation criteria were each assigned a top ranking from 6.6% to 1.7% of respondents. Medicines targeting a disease for which there is no alternative treatment available were ranked least important by 7.7% of respondents, compared with 2.4%, 1.9% and 1.0% for medicines treating severe diseases, diseases affecting children and cancer respectively. 'End-of-life treatments' and 'rare disease therapies' received the least number of highest priority rankings (2.0% and 1.7% respectively). Conclusions These results provide useful information about public preferences for government spending on prescribed medicines. Understanding of public preferences on the funding of new medicines will help the Pharmaceutical Benefits Advisory Committee and government determine circumstances where greater emphasis on equity is required and help inform medicines funding policy that best meets the needs of the Australian population. What is known about this topic? There is increased recognition of the importance of taking into account public preferences in the heath technology assessment (HTA) decision-making process. What does this paper add? The Australian public view the severity of disease to be the most important funding prioritisation criterion for medicines, followed by medicines used to treat children or to treat cancer. What are the implications for practitioners? The general public are capable of giving opinions on distributional preferences. This information can help inform medicines funding policy and ensure that it is consistent with the values of the Australian population.

A trial based economic evaluation of occupational therapy discharge planning for older adults: the HOME randomized trial.

OBJECTIVE: To compare the cost effectiveness of two occupational therapy-led discharge planning interventions from the HOME trial. DESIGN: An economic evaluation was conducted within the superiority randomized HOME trial to assess the difference in costs and health-related outcomes associated with the enhanced program and the in-hospital consultation. Total costs of health and community service utilization were used to calculate incremental cost-effectiveness ratios, activities of daily living and quality-adjusted life years. SETTING: Medical and acute care wards of Australian hospitals ( n=5). SUBJECTS: A total of 400 people ≥ 70 years of age. INTERVENTIONS: Participants were randomized to either (1) an enhanced program (HOME), involving pre/post discharge visits and two follow-up phone calls, or (2) an in-hospital consultation using the home and community environment assessment and the Lawton Instrumental Activities of Daily Living assessment. MAIN MEASURES: Nottingham Extended Activities of Daily Living (global measure of activities of daily living) and SF-12V2, transformed into SF-6D (quality-adjusted life year) measured at baseline and three months post discharge. RESULTS: The cost of the enhanced program was higher than that of the in-hospital consultation. However, a higher proportion of patients showed improvement in activities of daily living in the enhanced program with an incremental cost-effectiveness ratio of $61,906.00 per person with clinically meaningful improvement. CONCLUSION: Health services would not save money by implementing the enhanced program as a routine intervention in medical and acute care wards. Future research should incorporate longer time horizons and consider which patient groups would benefit from home visits.

Societal perspective on access to publicly subsidised medicines: A cross sectional survey of 3080 adults in Australia.

BACKGROUND: Around the world government agencies responsible for the selection and reimbursement of prescribed medicines and other health technologies are considering how best to bring community preferences into their decision making. In particular, community views about the distribution or equity of funding across the population. These official committees and agencies often have access to the best available and latest evidence on clinical effectiveness, safety and cost from large clinical trials and population-based studies. All too often they do not have access to high quality evidence about community views. We therefore, conducted a large and representative population-based survey in Australia to determine what community members think about the factors that do and should influence government spending on prescribed medicines. METHODS: A choice-based survey was designed to elicit the importance of individual criteria when considering the equity of government spending on prescribed medicines. A representative sample of 3080 adult Australians completed the survey by allocating a hypothetical budget to different combinations of money spent on two patient populations. Societal preferences were inferred from absolute majority responses i.e. populations with more than 50% of respondents' allocation for a particular allocation criterion. RESULTS: This study shows that, all else being equal, severity of disease, diseases for which there is no alternative treatment available on the government formulary, diseases that affect patients who are not financially well off, and life-style unrelated diseases are supported by the public as resource allocation criteria. Where 'all else is not equal', participants allocated more resources to the patient population that gained considerable improvement in health and fewer resources to those that gained little improvement in health. This result held under all scenarios except for 'end-of-life treatments'. Responses to cost (and corresponding number of patients treated) trade-off scenarios indicated a significant reduction in the proportion of respondents choosing to divide resources equally and a shift in preference towards devoting resources to the population that were more costly to treat for all criteria with the exception of severity of disease. CONCLUSIONS: The general public have clear views on what's fair in terms of government spending on prescribed medicines. In addition to supporting the application of the 'rule of rescue', important considerations for government spending included the severity of disease being treated, diseases for which there is no alternative treatment available on the government formulary, diseases that affect patients who are not financially well off and life-style unrelated diseases. This study shows that the general public are willing to share their views on what constitutes an equitable allocation of the government's drug budget. The challenge remains to how best to consider those views alongside clinical and economic considerations.

Is it all about price? Why requests for government subsidy of anticancer drugs were rejected in Australia.

BACKGROUND: Australians access anticancer drugs predominantly through the Pharmaceutical Benefits Scheme (PBS). AIM: To determine why the Pharmaceutical Benefits Advisory Committee (PBAC) rejects submissions to list anticancer drugs on the PBS. METHODS: We reviewed publicly available information about submissions made to the PBAC for PBS listing of anticancer drugs from 2005 to 2014. Submission characteristics, including clinical and economic evidence, PBAC recommendations, and the reasons offered for rejection were recorded. Two reviewers independently categorised the reason for rejection offered by the PBAC. Logistic regression was used to determine submission characteristics associated with rejection. RESULTS: We identified 213 submissions for 110 unique indications of 60 anticancer drugs. The overall rejection rate was 56% (119/213). Of the 110 indications assessed, 69% (76/110) were rejected at least once. The annual rejection rate ranged from 50 to 73% with little evidence of a trend over time (P = 0.2). Submission characteristics strongly associated with rejection in multivariable analysis included: PBAC judged the clinical evidence to be problematic or uncertain (P < 0.001); PBAC judged the economic evidence to be problematic or uncertain (P < 0.001); and, inactive comparator used (P < 0.001). The most frequent reasons for rejection offered by the PBAC was 'inadequate cost-effectiveness or drug price too high' (75/109, 69%). CONCLUSIONS: Inadequate cost-effectiveness and PBAC uncertainty about the clinical and economic evidence were the most frequent reasons for rejection. Clarity of information about PBAC deliberations and their reasons for rejection are important for patients and doctors grappling with decisions about the use of expensive unfunded anticancer drugs.

Occupational Therapy Predischarge Home Visits in Acute Hospital Care: A Randomized Trial.

OBJECTIVES: To determine whether an enhanced occupational therapy discharge planning intervention that involved pre- and postdischarge home visits, goal setting, and follow-up (the HOME program) would be superior to a usual care intervention in which an occupational therapy in-hospital consultation for planning and supporting discharge to home is provided to individuals receiving acute care. DESIGN: Randomized controlled trial. SETTING: Acute and medical wards. PARTICIPANTS: Individuals aged 70 and older (N = 400). MEASUREMENTS: Primary outcomes: activities daily living (ADLs; Nottingham Extended Activities of Daily Living) and participation in life roles and activities (Late Life Disability Index (LLDI)). RESULTS: Occupational therapist recommendations differed significantly between groups (P < .001) (HOME n = 892 recommendations; control n = 329 recommendations). There was no difference between groups in ADLs (Nottingham Extended Activities of Daily Living scale (NEADL): ß = -0.17, 95% confidence interval (CI) = -0.99-0.66) or participation (LLDI-Frequency: ß = -0.23, 95% CI = -2.05-1.59; LLDI-Limitation: ß = -0.14, 95% CI = -2.86-2.58). Both groups maintained prehospital functional status at 90 days, and there was no difference between groups in the number of people with unplanned readmissions (HOME 23.5%, n = 43; control 21.9%, n = 37). When groups were combined, being male (P = .03) or having lower perceived participation because of physical problems (P = .04) resulted in higher risk of unplanned readmissions. CONCLUSION: HOME discharge planning, which had a strong emphasis on task modification, well-being, and prevention strategies, implemented twice as many occupational therapy recommendations as the in-hospital only consultation, which had a greater emphasis on equipment provision, but HOME did not demonstrate greater benefit in global measures of ADLs or participation in life tasks than in-hospital consultation alone. It is not recommended that home visits be conducted routinely as part of discharge planning for acutely hospitalized medical patients. Further work should develop guidelines for quality in-hospital consultation.

Towards Integrating the Principlist and Casuist Approaches to Ethical Decisions via Multi-Criterial Support.

An interactive decision support tool based on Multi-Criteria Decision Analysis (MCDA) can help health professionals integrate the principlist (principle-based) and casuist (case-based) approaches to ethical decision making in both their training and practice. MCDA can incorporate generic ethical principles as criteria; then draw on case-based reasoning as the basis for specifying, in the individual case, the available options, the ratings of each option on each criterion, and the relative weighting of the criteria. This produces a personalised, transparent and decomposable opinion on the merits of each option, as a contribution to enhanced deliberation. As proof of concept and method an exemplar aid adds veracity and confidentiality to beneficence, non-maleficence, autonomy and justice, as the criteria, with case-based reasoning supplying the necessary inputs for the decision of whether a nurse should disclose the poor prognosis of a patient to a close relative of the patient, when asked, on their first encounter.

Personalised Multi-Criterial Online Decision Support for Siblings Considering Stem Cell Donation: An Interactive Aid.

Person-centred decision support combines the best available information on the considerations that matter to the individual, with the importance the person attaches to those considerations. Nurses and other health professionals can benefit from being able to draw on this support within a clinical conversation. A case study and storyline on four siblings facing a transplant coordinator's call to donate stem cells to their brother [1] is 'translated' and used to demonstrate how an interactive multi-criteria aid can be developed for each within a conversational mode. The personalized dialogue and decision aid are accessible online for interaction. Each sibling's decision exemplifies the communication including physical and psychosocial complexities within any decision cascade from call-to-test and to donate, if compatible. A shared template can embrace the informational and ethical aspects of a decision. By interactive decision support within a clinical conversation, each stakeholder can gain a personalised opinion, as well as increased generic health decision literacy [2].

The Role of Personalised Choice in Decision Support: A Randomized Controlled Trial of an Online Decision Aid for Prostate Cancer Screening.

IMPORTANCE: Decision support tools can assist people to apply population-based evidence on benefits and harms to individual health decisions. A key question is whether "personalising" choice within decisions aids leads to better decision quality. OBJECTIVE: To assess the effect of personalising the content of a decision aid for prostate cancer screening using the Prostate Specific Antigen (PSA) test. DESIGN: Randomized controlled trial. SETTING: Australia. PARTICIPANTS: 1,970 men aged 40-69 years were approached to participate in the trial. INTERVENTION: 1,447 men were randomly allocated to either a standard decision aid with a fixed set of five attributes or a personalised decision aid with choice over the inclusion of up to 10 attributes. OUTCOME MEASURES: To determine whether there was a difference between the two groups in terms of: 1) the emergent opinion (generated by the decision aid) to have a PSA test or not; 2) self-rated decision quality after completing the online decision aid; 3) their intention to undergo screening in the next 12 months. We also wanted to determine whether men in the personalised choice group made use of the extra decision attributes. RESULTS: 5% of men in the fixed attribute group scored 'Have a PSA test' as the opinion generated by the aid, as compared to 62% of men in the personalised choice group (χ2 = 569.38, 2df, p< 0001). Those men who used the personalised decision aid had slightly higher decision quality (t = 2.157, df = 1444, p = 0.031). The men in the personalised choice group made extensive use of the additional decision attributes. There was no difference between the two groups in terms of their stated intention to undergo screening in the next 12 months. CONCLUSIONS: Together, these findings suggest that personalised decision support systems could be an important development in shared decision-making and patient-centered care. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12612000723886.

Enhancing Healthcare Provider Feedback and Personal Health Literacy: Dual Use of a Decision Quality Measure.

In this protocol for a pilot study we seek to establish the feasibility of using a web-based survey to simultaneously supply healthcare organisations and agencies with feedback on a key aspect of the care experience they provide and increase the generic health decision literacy of the individuals responding. The focus is on the person's involvement in decision making, an aspect of care which is seriously under-represented in current surveys if one adopts the perspective of person-centred care. By engaging with an instrument to assess decision quality the person can, in the one action, provide a retrospective evaluation of a past decision making experience in a specific provider context and enhance their competency in future decision making in any setting. We see this as an exercise in context-sensitive educational health informatics.

Health Informatics Can Avoid Committing Symbolic Violence by Recognizing and Supporting Generic Decision-making Competencies.

'Symbolic violence' is committed, however well-intentionally, by the imposition of particular conceptualizations of what information, in what form and quality, is needed in order to make an 'informed choice' and hence - by questionable segue - a high quality decision. The social and cultural forms of relevant cognitive capital possessed by those who fail, because of their low general literacy, professionally-set knowledge tests of functional health literacy, are being ignored. Failing to recognise and exploit a particular form of functional decision literacy, in fact leads to symbolic violence being experienced by individuals at any and all levels of general literacy. It leads many to adopt the same range of avoidant and other undesirable strategies within healthcare situations observed in those of low basic literacy. The alternative response we propose exploits the alternative generic decision literacy which comes in the form of the ability to access and use the decision-relevant resources provided for many consumer services and products on comparison websites and magazines. The methodology is the simple form of multi-criteria analysis in which the products' ratings on multiple criteria are combined with criterion weights (supplied by the site) to produce scores and 'best buys' and 'good value for money' verdicts. Our alternative approach extends this approach to healthcare options and permits the incorporation of personal criterion weights in furtherance of person-centred care. Health informaticians, especially those in the decision support field, should build on this widespread generic competence. The fact that it is generic, far from implying context insensitivity, can be seen as a necessary basis for achieving context-sensitivity and sensitivisation at the level of the individual person as they experience a lifelong sequence of healthcare decisions.

Developing an Online Decision Aid for Osteoarthritis.

A decision aid for osteoarthritis was developed using the best available evidence on effect size, potential harms and self-rated performance for other attributes. The aid was developed using a multi-criteria decision analytic tool capable of combing evidence and an individual's preferences for the attributes related to treatment.

Improving Quality of Life for People with Incurable Large-Bowel Obstruction: Randomized Control Trial of Colonic Stent Insertion.

BACKGROUND: Surgery remains the dominant treatment for large-bowel obstruction, with emerging data on self-expanding metallic stents. OBJECTIVE: The aim of this study was to assess whether stent insertion improves quality of life and survival in comparison with surgical decompression. DESIGN: This study reports on a randomized control trial (registry number ACTRN012606000199516). SETTING: This study was conducted at Royal Prince Alfred Hospital, Sydney, and Western Hospital, Melbourne. PATIENTS AND INTERVENTION: Patients with malignant incurable large-bowel obstruction were randomly assigned to surgical decompression or stent insertion. MAIN OUTCOME MEASURES: The primary end point was differences in EuroQOL EQ-5D quality of life. Secondary end points included overall survival, 30-day mortality, stoma rates, postoperative recovery, complications, and readmissions. RESULTS: Fifty-two patients of 58 needed to reach the calculated sample size were evaluated. Stent insertion was successful in 19 of 26 (73%) patients. The remaining 7 patients required a stoma compared with 24 of 26 (92%) surgery group patients (p < 0.001). There were no stent-related perforations or deaths. The surgery group had significantly reduced quality of life compared with the stent group from baseline to 1 and 2 weeks (p = 0.001 and p = 0.012), and from baseline to 12 months (p = 0.01) in favor of the stent group, whereas both reported reduced quality of life. The stent group had an 8% 30-day mortality compared with 15% for the surgery group (p = 0.668). Median survival was 5.2 and 5.5 months for the groups (p = 0.613). The stent group had significantly reduced procedure time (p = 0.014), postprocedure stay (p = 0.027), days nothing by mouth (p = 0.002), and days before free access to solids (p = 0.022). LIMITATIONS: This study was limited by the lack of an EQ-5D Australian-based population set. CONCLUSIONS: Stent use in patients with incurable large-bowel obstruction has a number of advantages with faster return to diet, decreased stoma rates, reduced postprocedure stay, and some quality-of-life benefits.

Public preferences for engagement in Health Technology Assessment decision-making: protocol of a mixed methods study.

BACKGROUND: Much attention in recent years has been given to the topic of public engagement in health technology assessment (HTA) decision-making. HTA organizations spend substantial resources and time on undertaking public engagement, and numerous studies have examined challenges and barriers to engagement in the decision-making process however uncertainty remains as to optimal methods to incorporate the views of the public in HTA decision-making. Little research has been done to ascertain whether current engagement processes align with public preferences and to what extent their desire for engagement is dependent on the question being asked by decision-makers or the characteristics of the decision. This study will examine public preferences for engagement in Australian HTA decision-making using an exploratory mixed methods design. METHODS/DESIGN: The aims of this study are to: 1) identify characteristics about HTA decisions that are important to the public in determining whether public engagement should be undertaken on a particular topic, 2) determine which decision characteristics influence public preferences for the extent, or type of public engagement, and 3) describe reasons underpinning these preferences. Focus group participants from the general community, aged 18-70 years, will be purposively sampled from the Australian population to ensure a wide range of demographic groups. Each focus group will include a general discussion on public engagement as well as a ranking exercise using a modified nominal group technique (NGT). The NGT will inform the design of a discrete choice study to quantitatively assess public preferences for engagement in HTA decision-making. DISCUSSION: The proposed research seeks to investigate under what circumstances and how the public would like their views and preferences to be considered in health technology assessments. HTA organizations regularly make decisions about when and how public engagement should occur but without consideration of the public's preferences on the method and extent of engagement. This information has the potential to assist decision-makers in tailoring engagement approaches, and may be particularly useful in decisions with potential for conflict where clarification of public values and preferences could strengthen the decision-making process.