Marissa Collins

NICE’s end of life decision making scheme: impact on population health

Marissa Collins and Nicholas Latimer quantify the impact of raising the cost effectiveness threshold for end of life drugs and find that the effect on other NHS services could be substantial

Pelvic floor muscle training for secondary prevention of pelvic organ prolapse (PREVPROL): a multicentre randomised controlled trial

BACKGROUND Pelvic floor muscle training can reduce prolapse severity and symptoms in women seeking treatment. We aimed to assess whether this intervention could also be effective in secondary prevention of prolapse and the need for future treatment. METHODS We did this multicentre, parallel-group, randomised controlled trial at three centres in New Zealand and the UK. Women from a longitudinal study of pelvic floor function after childbirth were potentially eligible for inclusion. Women of any age who had stage 1-3 prolapse, but had not sought treatment, were randomly assigned (1:1), via remote computer allocation, to receive either one-to-one pelvic floor muscle training (five physiotherapy appointments over 16 weeks, and annual review) plus Pilates-based pelvic floor muscle training classes and a DVD for home use (intervention group), or a prolapse lifestyle advice leaflet (control group). Randomisation was minimised by centre, parity (three or less vs more than three deliveries), prolapse stage (above the hymen vs at or beyond the hymen), and delivery method (any vaginal vs all caesarean sections). Women and intervention physiotherapists could not be masked to group allocation, but allocation was masked from data entry researchers and from the trial statistician until after database lock. The primary outcome was self-reported prolapse symptoms (Pelvic Organ Prolapse Symptom Score [POP-SS]) at 2 years. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT01171846. FINDINGS Between Dec 21, 2008, and Feb 24, 2010, in New Zealand, and Oct 27, 2010, and Sept 5, 2011, in the UK, we randomly assigned 414 women to the intervention group (n=207) or the control group (n=207). One participant in each group was excluded after randomisation, leaving 412 women for analysis. At baseline, 399 (97%) women had prolapse above or at the level of the hymen. The mean POP-SS score at 2 years was 3·2 (SD 3·4) in the intervention group versus 4·2 (SD 4·4) in the control group (adjusted mean difference -1·01, 95% CI -1·70 to -0·33; p=0·004). The mean symptom score stayed similar across time points in the control group, but decreased in the intervention group. Three adverse events were reported, all of which were in the intervention group (one women had a fall, one woman had a pain in her tail bone, and one woman had chest pain and shortness of breath). INTERPRETATION Our study shows that pelvic floor muscle training leads to a small, but probably important, reduction in prolapse symptoms. This finding will be important for women and caregivers considering preventive strategies. FUNDING Wellbeing of Women charity, the New Zealand Continence Association, and the Deans Bequest Fund of Dunedin School of Medicine.

Contrasting cardiovascular mortality trends in Eastern Mediterranean populations: Contributions from risk factor changes and treatments

BACKGROUND Middle income countries are facing an epidemic of non-communicable diseases, especially coronary heart disease (CHD). We used a validated CHD mortality model (IMPACT) to explain recent trends in Tunisia, Syria, the occupied Palestinian territory (oPt) and Turkey. METHODS Data on populations, mortality, patient numbers, treatments and risk factor trends from national and local surveys in each country were collated over two time points (1995-97; 2006-09); integrated and analysed using the IMPACT model. RESULTS Risk factor trends: Smoking prevalence was high in men, persisting in Syria but decreasing in Tunisia, oPt and Turkey. BMI rose by 1-2 kg/m(2) and diabetes prevalence increased by 40%-50%. Mean systolic blood pressure and cholesterol levels increased in Tunisia and Syria. Mortality trends: Age-standardised CHD mortality rates rose by 20% in Tunisia and 62% in Syria. Much of this increase (79% and 72% respectively) was attributed to adverse trends in major risk factors, occurring despite some improvements in treatment uptake. CHD mortality rates fell by 17% in oPt and by 25% in Turkey, with risk factor changes accounting for around 46% and 30% of this reduction respectively. Increased uptake of community treatments (drug treatments for chronic angina, heart failure, hypertension and secondary prevention after a cardiac event) accounted for most of the remainder. DISCUSSION CHD death rates are rising in Tunisia and Syria, whilst oPt and Turkey demonstrate clear falls, reflecting improvements in major risk factors with contributions from medical treatments. However, smoking prevalence remains very high in men; obesity and diabetes levels are rising dramatically.

Cost-effectiveness analysis of eliminating industrial and all trans fats in England and Wales: modelling study

Introduction Coronary heart disease (CHD) remains a leading cause of UK mortality. Dietary trans fats (TFA) represent a powerful CHD risk factor. However, UK efforts to reduce intake have been less successful than other nations. We modelled the potential health and economic effects of eliminating industrial and all TFA up to 2020. Methods We extended the previously validated IMPACTsec model, to estimate the potential effects on health and economic outcomes of mandatory reformulation or a complete ban on dietary TFA in England and Wales from 2011 to 2020. We modelled two policy scenarios: 1) Elimination of industrial TFA consumption, from 0.8% to 0.4% daily energy 2) Elimination of all TFA consumption, from 0.8% to 0% Results Elimination of industrial TFA across the England and Wales population could result in approximately 1600 fewer deaths per year, with some 4000 fewer hospital admissions; gaining approximately 14 000 additional life years. Health inequalities would be substantially reduced in both scenarios. Elimination of industrial TFA would be cost saving. This would include approximately £100 m saved in direct healthcare costs. Elimination of all TFA would double the health and economic gains. Conclusions Eliminating industrial or all UK dietary intake of TFA could substantially reduce CHD mortality and inequalities, while resulting in substantial annual savings.

Is “end of life” a special case? Connecting Q with survey methods to measure societal support for views on the value of life-extending treatments

Abstract Preference elicitation studies reporting societal views on the relative value of end‐of‐life treatments have produced equivocal results. This paper presents an alternative method, combining Q methodology and survey techniques (Q2S) to determine the distribution of 3 viewpoints on the relative value of end‐of‐life treatments identified in a previous, published, phase of this work. These were Viewpoint 1, “A population perspective: value for money, no special cases”; Viewpoint 2, “Life is precious: valuing life‐extension and patient choice”; and Viewpoint 3, “Valuing wider benefits and opportunity cost: the quality of life and death.” A Q2S survey of 4,902 respondents across the United Kingdom measured agreement with these viewpoints; 37% most agreed with Viewpoint 1, 49% with Viewpoint 2, and 9% with Viewpoint 3. Regression analysis showed associations of viewpoints with gender, level of education, religion, voting preferences, and satisfaction with the NHS. The Q2S approach provides a promising means to investigate how in‐depth views and opinions are represented in the wider population. As demonstrated in this study, there is often more than 1 viewpoint on a topic and methods that seek to estimate that averages may not provide the best guidance for societal decision‐making.

Eliciting Societal Views on the Value of Life-Extending Treatments Using Q Methodology

Publicly funded healthcare systems operating with fixed budgets must incorporate rationing mechanisms of some sort in order to set priorities. Efficiency, which might be defined broadly in health terms as maximising health benefits with respect to cost, is a key consideration in setting priorities. However, efficiency is not the only consideration, and members of society may value other issues in relation to the distribution of resources to different groups of beneficiaries. Life-extending treatments for people with terminal illnesses, which are non-curative by definition and often produce relatively small health gains in relation to their costs, are a prime example of technologies that might not satisfy usual cost-effectiveness thresholds. It is generally accepted that the views and values of members of the public, as taxpayers and potential patients, are relevant in determining priorities in the provision of publicly funded healthcare. This chapter introduces Q methodology as a structured approach to eliciting and describing societal values, combining qualitative and quantitative techniques to study subjectivity, with reference to research carried out relating to people at the end of their lives.

Resource allocation in integrated care settings: what works? Case of Health and Social Care Partnerships in Scotland

Background : The move towards integration between health and social care, as embodied in the Public Bodies (Joint Working) (Scotland) Act 2014 and similar acts in England and Wales, challenges local delivery organisations to consider the cost, quality and the value of services provided for local populations. To meet this challenge, especially when set against a background of public sector austerity, managers and staff need robust, effective frameworks to help them make decisions which are defensible and based on sound evidence. Given the intention of the above legislation, such frameworks for priority setting must also be able to aid decisions about the appropriate balance of care (i.e. the respective amounts of resources devoted to the NHS, social care and other relevant providers). One such framework for priority setting is Programme Budgeting and Marginal Analysis (PBMA). PBMA is a generic economic framework and offers an analytical approach for assessing the costs and benefits of alternative courses of action, which could assist with identification of the effects of resource shifts and areas for disinvestment among programmes. Programme Budgeting (PB) involves the presentation of estimates of expenditure and activity across and within ‘programmes’ of care or service delivery. Marginal Analysis (MA) involves evaluation of incremental changes in costs and consequences when resources in programmes are used in different ways; essentially analysing the effects of changing the balance of expenditure within a given budget. MA identifies where additional resources should be targeted, where reductions should be made if expenditure must be cut, and how resources can be reallocated to achieve an overall gain in benefits with no overall change in expenditure. In order to test out the feasibility of using such a framework in newly formed Health and Social Care Partnerships (H&SCPs), three pilot sites in Scotland were selected: Highland, Ayrshire & Arran and Perth & Kinross. We worked closely with Highland, who conducted the process in two localities (one urban and one rural), and I will focus on the lessons learned from using such a framework in these integrated care settings. Methods : Interviews were conducted with those working in Highland to learn about their understanding of current priority setting processes. Workshops outlining the economic principles and theory of PBMA were held in both localities and from this Advisory Groups were formed to lead the process in each site, and field notes have been gathered from working with these groups and associated events. Highlights : The PBMA process provided the pilot sites with a transparent, inclusive and structured approach to prioritisation. It promoted debate and critical appraisal of options amongst stakeholders based on an understanding of the benefits and costs associated with the potential choices and provided a basis by which decisions could be justified. By considering the current use of resources across a programme, alongside the potential alternatives, the PBMA process combines investment with disinvestment decisions. A particular strength was the role and composition of the Advisory Groups. The benefit of including other stakeholders, such as service users, carers and service providers, alongside statutory providers in a co-production approach was evident. The pilots required investment to apply the technique, generate buy-in, facilitate meetings, liaise with public representatives, perform analysis and present results. Although some of the time required for this will have been associated with establishing the process, there will be a recurrent cost required to administer it on a regular basis. In addition, clinician’s time will need to be protected to allow participation. To ensure the process is effective will require robust datasets on, for example, current service patterns, resource utilisation and outcomes, and population needs assessments. There is a risk that this places a significant additional demand on local systems. However, it could be argued that this level of information is what is required for effective prioritisation and its unavailability is a problem for current processes rather than for PBMA. Conclusion : Despite some barriers to implementation, the test sites were very positive about the approach taken and allowed them to progress with a decision making process while changing thinking of those involved of how decisions are made and resources can be (re)allocated within health and social care. The structured approach allows for organisations to be more explicit about the basis of decisions and focus on the entirety of resources. As a result, PBMA has been included in Statutory Guidance in Scotland as an approach for use in developing Strategic Commissioning Plans by H&SCPs established under the new legislation.

OP13 An Economic Evaluation of Salt Reduction Policies to Reduce Cardiovascular Disease in England: A Policy Modelling Study

Background Dietary salt intake has been causally linked to high blood pressure and increased risk of cardiovascular events. Cardiovascular disease (CVD) causes approximately 35% of total UK deaths, at an estimated annual cost of £30 billion with £14.4 billion spent on treating CVD per year. WHO and NICE have both strongly recommended dietary salt reduction. However, to implement more effective policies in future, UK policy makers will need robust evidence to assess the costs and benefits of specific interventions. Methods A validated model called IMPACT CHD, calibrated for England’s population aged 25 to 85+ years, was used to quantify and compare four population salt reduction policies. These interventions comprised: 1) Change4Life health promotion campaign, 2) front of pack traffic light labelling to display food salt content, 3) Food Standards Agency continuing to work with the food industry to reduce salt on a voluntary basis or 4) Mandatory reformulation (legislation) to reduce salt in processed foods. The effectiveness of these policies in reducing salt intake, and hence blood pressure, was determined by systematic literature review. The IMPACT CHD model was used to calculate the reduction in mortality associated with each policy, quantified as life years gained over 10 years. The cost of each policy used published evidence from the Department of Health and Food Standards Agency. Health care costs for specific CHD patient groups were estimated and compared against a “do nothing” baseline. A ten-year time horizon was taken from 2007 (the model baseline year) to 2017. Policy and health care costs were discounted at 3.5%. Probabilistic sensitivity analysis was used to quantify uncertainty. Results All policies resulted in a life year gain over the baseline. Change4life and labelling each resulted in a gain of approximately 1960 life years, voluntary reformulation a gain of some 14,560 life years and mandatory reformulation approximately 19,320 life years. The costs of each policy appeared cost saving against the baseline. Mandatory reformulation apparently offered the largest cost saving, over £660 million compared to baseline. Conclusion All population health interventions to reduce dietary salt intake on an English population appear cost saving and could substantially reduce health care expenditure on cardiovascular disease. Mandatory reformulation of processed foods might achieve the highest reduction in dietary salt intake and therefore the largest savings.