Measure For Measure

Dedicated to quality of everyday lives

Points of view March 2009 Measure for measure: Assessing quality of life in healthcare Introduction “The NHS of the future will be more than a universal service – it will be a personal service too ... The NHS of the future will be one of patient power, patients engaged and taking greater control over their own health and their healthcare too.” This was one of the Prime Minister’s key points in a speech at King’s College, London on 7th January 2008. Lord Darzi in his High Quality Care for All report drove that message home and stated that quality must be at the heart of our 21st Century healthcare system. He talked about high quality care, quality staff and training, underpinned by quality information, quality accounts and the evidence from quality measurement systems. “...The national metrics will be important, but it will be critical that local NHS organisations should sign up to the concept of quality metrics and feel motivated to augment the national indicators with their own measurements of quality… A range of quality measures covering safety, clinical outcomes, patient experience and patient views about the success of their treatment – known as patient reported outcome measures or PROMS – will be used...”(1) Effectiveness measures are a central feature of what the government defines as excellent care. According to Lord Darzi: “…this means understanding success rates for different treatments for different conditions. Assessing this will include clinical measures, such as mortality or survival rates, complication rates and measures of clinical improvement. Just as important is the effectiveness of care from the patient’s own perspective which will be measured through patientreported outcomes measures (PROMs).”(1)

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No doubt everyone agrees with these sentiments and will embrace these policies. What is interesting about Lord Darzi’s Review and the Prime Minister’s sentiments is that they are based on traditional ways to measure outcomes or on measures that are important to the capacity of the NHS and its outcomes as a national system. The latter are of course critical in assessing budgets, determining healthcare professionals' performance-based pay or setting Primary Care Trusts’ (PCTs) priorities. But what we do not hear about explicitly are any indicators of the quality of the patient’s everyday life whether that be short-term or, more importantly, longer term. Yes, patients want quality care, the best doctors, nurses and relevant and timely information. But what most want is the best possible quality of living between their engagements with the system. Consider the views of two patients interviewed for a research project: “What do patients really mean by Quality of Life”: (2) “Quality of life is of the upmost importance. Where possible, the condition should not dominate. We must be encouraged to manage, incorporating the condition into our lives” Or: “The concept of quality of life has been taken over and owned by managers who use Quality Adjusted Life Years (QALYs) to decide which treatments should be made available to which patients. I am strongly opposed to this occupancy of the concept. It is for individuals to decide on how they define the quality of their lives. Life is precious for most people, whatever their age or medical condition.” Quality-of-living indicators are as broad, subjective, varied and hard to pin-down as human beings themselves. They are the elusive factors that can influence the ways people carry out their treatment recommended by their doctor. They are the drivers of human behaviour that can stand in the way of following the best possible recommended treatment. Yet, these are the very reasons why they must be included as an integral component of policy and practice formulation. This report is about challenges: the challenge of creating legitimate agreement around the need for, and the nature of, people-derived quality of living indicators as measures of health outcomes. It is also about the challenge of institutionalising such measures within the NHS, and then using them as acceptable criteria for continued public support of the NHS.

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Executive summary and key points Since 1998, the Department of Health has recognised that patients’ needs are not always fully taken into account when care is planned and delivered (2). The needs and priorities of patients are complex and wide-ranging and are not easy to identify or to measure. In 2008, the Government announced its intention to introduce more stringent measurement tools within the NHS to include clinical measures such as survival rates, measures of clinical improvement and effectiveness of care from the patient’s point of view – known as PROMs. Although the private healthcare system has been using PROMs for some ten years, they will be put in place for the first time within the NHS system from April 2009. Critically, PROMs will only be used initially for four common elective procedures. They will not be used on a national basis for the millions of people who suffer from long-term and chronic diseases – an omission which needs to be rectified at the earliest possible date. Are the current and new measurement tools going to provide the “excellent care” promised by the Government? Will they actually provide new measurements that could make a difference to patients’ needs and to the quality of their lives or will they just be using different measurement tools that provide the same information? Measuring health-related quality of life presents considerable challenges. The instruments currently in use and the ones that will be used by the NHS have been designed largely by psychologists, researchers, scientists and health economists but not by patients. They will, no doubt, provide useful information for clinicians and managers in terms of statistical data and efficiency ratings. However, we would challenge the validity of the existing tools in terms of providing a satisfactory and meaningful quality of life measurement. The questionnaires neither provide the detail necessary to gauge either positive or negative changes in daily living conditions; nor do they provide any definition of quality of life in relation to the expectations and aspirations of the patient. Health related quality of life is totally unique to an individual; it depends not only on a person’s state of health but that person’s age, state of mind, the help they have on a regular basis and their ability to engage positively and proactively with the healthcare professionals they see. Will PROMs just add to the already large mountains of paper, questionnaires and surveys currently produced by the NHS to establish patients’ satisfaction with GPs, clinicians and hospitals? Will PROMs actually capture any new data and will it be the right data that can work towards improving the quality of patients’ lives? The key to successful measurement has to be whether it impacts positively on quality of care together with the patients’ perception of that care and their quality of living both short and longterm. The indicators that define a person’s health-related quality of life are so personal and so changeable, it is difficult to see how that fits easily with the large scale machine of the NHS.

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If true health-related quality of life is to be measured effectively, today’s PROMs are probably not the answer. It will take a change of mindset both by patients and by healthcare professionals. It will take proactive participation by patients to help define their goals and the treatment they receive and to say how their lives are or could be affected. It will require risk, imagination and creativity as well as considerable resources. However, surely patients have a right to expect that improving the quality of their lives should be a key principle of the NHS and at the heart of our Government’s desire to achieve “quality care for all”.

Quality of life: What it really means for health Measuring a short-term success whether it is in-patient hospital care or a clinical procedure is a statistical operation and provides a very tangible and valuable outcome. Those are critical to both policy formation and the broad dissemination of best practice. However, measuring longer-term quality of living is far more subjective and will probably need alternative methods to the ones currently available – not an easy task but surely one that will be of equal or greater importance to the patient. Putting quality at the centre of our NHS can be better achieved if it also achieves measurable improvements in patient’s perceptions of better quality of living. The first Changing Diabetes Barometer report published by Novo Nordisk in November 2007 says that improving lives must be the goal (3) and although data on clinical parameters such as HbA1c are intermediate outcomes, and give a guide to the progression of the disease, it is not something which is “felt” by the person with diabetes. Through appropriate education and information people with diabetes can be encouraged to understand these measurements better but they will naturally always be more interested in “hard outcomes” including the physical complications of the disease, the impact of both their treatment and their disease on their daily life and their prospects for productive independent living. Too often the concept of quality of life is dismissed as an additional luxury to be considered once basic survival is ensured. In chronic disease treatment, however, it is the central aim because keeping the person with a chronic disease living as normally possible, for as long as possible, should be the desired objective. For some patients, the perception of improved quality of life depends on their feeling of safety that their treatments and care team are the most up-to-date and the most competent that could be found. In the 2007 QALYity project, when asked what they really mean by quality of life, one indicator drew a consistently high response regardless of medical condition or background: “Getting the correct treatment or care”(2). For other patients, improving their quality of life may mean a different lifestyle because the reality of disease has changed their lives forever. Additional indicators may simply mean a return to normality whether that is walking the dog again, travelling, enjoying a favourite hobby or returning to work. For some patients, improving their quality of life may mean a different lifestyle because the reality of disease has changed their lives forever. A report for Oxford Vision 2020 (4) talks about how patients are changing in their attitudes to long-term diseases and will continue to change.

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They are becoming more knowledgeable in developing a new and holistic self-understanding of their condition. Many are embracing techniques that go well beyond what their doctor offers including alternative medical procedures, functional foods, psychological support and informationrich community networks. As a younger generation of patients start to question the historic paternalistic nature of the National Health Service, we are likely to see far more patients playing a proactive role in the self management of their condition.

What does measurement of quality of life really mean in the context of health and care? There is a growing field of research concerned with developing, evaluating and applying quality of life measures within a health related context. A prime example is health services research, which looks at the performance of both structure and systems and how they affect people. Many of these research projects focus on the measurement of health related quality of life (HRQoL), deliberately overlooking economic and social conditions that go beyond what healthcare systems can affect. Governments as well as healthcare companies have recognised the growing need to understand what impact medical interventions have on patients’ lives as well as their bodies. Traditionally the focus for measuring the effectiveness of care has been on measuring process and clinical indicators rather than patient defined outcomes, but it is becoming increasingly important to be able to monitor and provide information on individual patient defined outcomes. Will these measurements help improve what patients with long term conditions consider to be their quality of everyday life? Are we measuring different things, or just using different measures? There are literally hundreds of different measurement instruments in use throughout the world, some generic and some disease-specific. (5) Mostly, they take the form of self completed questionnaires designed to measure the effectiveness of interventions and procedures, the quality of service and the need for further care. Many of the existing measurement tools impose standardised models of quality of life and preselected areas of questioning. They could, therefore, be considered a general measurement of health status rather than a tool that allows patients to define their quality of life in relation to their own expectations and aspirations.

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Perspectives on measurement The consensus approach The National Institute for Health and Clinical Excellence (NICE) uses the Quality Adjusted Life Year (QALY) as part of its calculation when formulating clinical guidance on the use of drugs and other medical interventions.(6) The QALY combines quality of life on a scale of 0 (death) to 1 (perfect health), life expectancy and cost considerations into one figure. Predicted change in quality of life is established from clinical evidence and information is taken from survey samples from patients, carers and health professionals. A formula then combines the predicted change, duration of treatment, effect and cost. The result is expressed in Quality Adjusted Life Years.

The QALY – help or hindrance? Should the QALY be so dominant a factor in determining which medical interventions receive NHS funding? Looking at the decision in 2005 to withdraw, four key drug treatments for Alzheimer’s in its early stages, there is an argument against the dominance of the QALY. The guidance from NICE was based on QALY analysis of clinical trials and the drugs achieved scores ranging between £88,000 and £50,000 (well above the acceptable figure of £20,000 per QALY.(7) This guidance was heavily criticised by the Royal College of Psychiatrists partly due to two sets of contradictory guidance being issued within the space of four years.(8) In 2001, NICE considered the QALY inappropriate for those with cognitive impairment especially given the fact that carers may be poor proxies. Yet in 2005, it did indeed apply the QALY when issuing guidance on Alzheimer’s drugs and used an American study based on carers as proxies to determine quality of life. However, the reasons for the change in direction are at best vague; NICE simply states that the evidence base has matured.(9)

Patient reported outcome measurements (PROMs) The Government announced in 2008 its intention to introduce the collection of PROMs from April 2009. Whilst not new (a wide range of PROMs has been developed to provide clinical diseasespecific measurement outcomes as well as generic measurement outcomes), they will now be used in the NHS to provide the patient’s perspective on a national basis. Initially PROMs will cover only hip and knee replacements, hernias and varicose veins. Interestingly no long-term or chronic diseases have been included perhaps because they are not as easy to measure, they may not produce tangible, reportable outcomes or they won’t show an increase in efficiency in the healthcare being provided. We would hope that if PROMs are considered successful, they will be extended to include other conditions and procedures.

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How PROMs will work PROMs will take the form of self completed questionnaires on a pre and post-operative basis for all patients aged 16 or over. Patients will be asked to complete the first questionnaire without assistance on the day of admission to hospital; the second will be sent by post either three months or six months after the procedure with a further follow-up letter if necessary to assist with data collection. There will be some people excluded from submitting questionnaires and these generally relate to those with literacy or eyesight problems or those with cognitive impairment. There are many measurement tools and questionnaires available but within the NHS, all procedures will utilise the EQ-5D to obtain generic information (see box). Condition specific data will be collected through using the Oxford Hip Score, the Oxford Knee Score or the Aberdeen Varicose Vein Score. There is currently no appropriate instrument to cover Hernia procedures. The cost of administering PROMs in the NHS is anticipated to be £5 per patient (10). The type of questions included in the EQ-5D, which will be used by the NHS, cover five areas: • Mobility • Self care • Usual activities (e.g. work, study, family or leisure) • Pain/discomfort • Anxiety/depression For each area, the questionnaire simply asks if the patient has no problems in this area, some problems or extreme problems. It also asks them to indicate on a chart how good or bad their health is today. The SF-36 questionnaire is considerably more detailed, looking at specific everyday activities, how life has been affected and if there has been any improvement. This questionnaire tends to be used in the private healthcare sector but has not been recommended for the NHS. The PROMs are heralded as a major advance within the NHS planning, and it is. There are, however, some methodological issues that arise: • The instrument is designed to provide information reported by the patient, but it does not necessarily provide the information or perspective that is important to the patient. It appears that the source rather than the focus or content is taking precedence. It is therefore fair to question why the EQ-5D has been chosen as the NHS’s preferred measurement tool, particularly as it does not ask for any concrete detail on how people's lives have changed positively or negatively. • Some experts feel that the clinical setting in which the questionnaire will be first administered will bias the responses, as “no patient will want to be seen to be criticising the medical team/facilities after waiting for the procedure and prior to operations”. (Professor David Matthews) • Other experts question the clinical value of evidence from self reported comments on quality of life when it comes to people who have long term conditions (we assume, of course, that ultimately PROMs will be used for every aspect of NHS care).

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According to Professor David Matthews, Chair of the Model Group: “First of all realities change constantly when you have a condition for life. So the PROMs timeframes may not suit the ebbs and flows of the disease/treatment pathways. Secondly, as a testimony to the greatness of the human spirit, I have often wondered how people can adjust and rationalise disaster. I have several amputee patients who have reported being happy, despite loss of limb, because now they didn't need to wash the dishes or their friends come to visit them. Asking people directly to report on quality of life is not going to provide the information we need. We have to find surrogate measures that will allow us to deduce quality of life outcomes, in the way depression can be deduced from severe variations in sleep, appetite or libido.”

Some widely utilized quality of life measurements EQ-5D

The approach most widely used in the European Union, it is a quick and simple measure of overall health, often used to compare the effect of a variety of different interventions on patient health. SF-36

Developed by the RAND Corporation and the Medical Outcomes Study in the 1980s, it consists of 36 questions and can provide a more detailed overall measure of health related quality of life and to provide scores based on eight physical, mental and social dimensions. Nottingham Health Profile

Developed by Stephen P McKenna, 38 questions are each assigned a weighted value. A second part examines areas of a patient’s life affected by their condition The WHOQOL-100

A generic, patient-completed measure of health-related quality of life that was developed in 15 sites worldwide, it is focused on the definition of quality of life advocated by the World Health Organisation, which includes the culture and context which influence an individual's perception of health. A short version with just 26 items also exists (WHOQOL-BREF). Scores for four domains (physical, psychological, social relationships, and environment) as well as an overall score can be produced.

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The independent healthcare sector has been using PROMs for some years. BUPA, in particular, first introduced them almost 10 years ago and sees them as valuable tools to measure health status, to compare results between hospitals and to raise standards. BUPA has stated it would like to see them as compulsory tools in all private hospitals and to work towards a shared private sector-NHS database to provide patients with fair comparisons and true choice.(10)

The full introduction of PROMs follows a pilot study with 2,400 patients in 24 NHS sites covering only elective care and emergency patients and run by the National School of Hygiene and Tropical Diseases. Working with a private survey organisation (Clinical Health Knowledge Services), the pilot study did not include any patients suffering from chronic diseases.

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There may be good reasons for this such as the complexities in gathering the data over a period of time and, of course, the costs involved in such an exercise but it would be disappointing if this was not made a priority for the future. BUPA is clearly happy with the validity of the PROMs data it collects but how valid will the data be when PROMs are introduced nationally in NHS hospitals? In the NHS pilot study, the proportion of elective patients for whom pre and post treatment data was collected was worryingly low – between 4% and 17% although it was higher (up to 44%) for emergency patients.(11) Given this low percentage, it is fair to assume that there is a danger that post-treatment questionnaires will be treated as yet more junk mail. Unless the questionnaires are improved and a 65%-75% response rate is achieved, it will be difficult to gauge the validity of the data and to see how PROMs will help the patient.

Patient satisfaction The NHS has been surveying patient satisfaction for many years whether it is in primary care, acute care or specialist units such as mental health. More recently, it has also tried to measure satisfaction and performance for some chronic diseases such as diabetes, cancer and coronary heart disease. One thing is certain. There is a plethora of paper flying between the co-ordinators of such NHS surveys and patients before being analysed, reanalysed and then published. But what data and information is being captured? Is it the right data and does it really work towards improving the health-related quality of patients’ lives? All NHS Trusts are required to carry out local surveys asking patients for their views on recent healthcare experiences. Conducted on behalf of the Healthcare Commission, so far more than 1.4 million patients have been asked for such feedback.(12) The two principal and ongoing studies are the National Patient Survey and the GP survey but there are numerous additional studies covering Accident & Emergency, elective and emergency treatments and mental health. There is no doubt that these surveys have improved dramatically over time. Collecting patients’ views on waiting times, integration of care, treatment and prognosis, communication, physical comfort, emotional support and respect for patients’ values is, of course, vital to highlight problems and to deliver improvements in standards of service and care. We certainly learn about patients’ likes and dislikes but perhaps these surveys are again too focused on the agendas of clinicians or NHS managers. Perhaps they are focused on highlighting the efficiencies of the healthcare system rather than the concerns of the patient. Very often, patients (particularly older ones) are reluctant to criticise doctors and nurses and so this can result in very high satisfaction ratings which are maybe used to elicit PR hype.

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The well-being platform As previously discussed, the detail contained in The SF-36 generic survey does appear considerably more useful than the EQ-5D, which is simply a set of five multiple choice questions together with a graph to convey state of health. An in-between positive alternative might be the well-being test developed by the World Health Organisation (WHO-5), which gauges surrogate indicators in order to reduce bias which allows personalised responses within the normal framework of a scale. Although the WHO-5 is primarily concerned with mental health, this is an area of vital importance to quality of life, particularly to those living with chronic diseases and it could represent a good model for use with other long-term diseases. The WHO-5 consists of 5 positive statements: "I have felt cheerful and in good spirits." "I have felt calm and relaxed." "I have felt active and vigorous." "I woke up feeling fresh and rested." "My daily life has been filled with things that interest me." Each of these items is scored from 0 (not present) to 5 (constantly present) by the patients. The total score is multiplied to provide a range between 0 and 100. Scores of less than 50 suggest poor emotional well-being and invite further testing. A score of 28 or less indicates depression. The questionnaire is administered in short intervals to measure changes particularly for those currently receiving treatment and provides a good barometer of the disease progression, of the person's state of mind and potentially of what quality of living and attendant benefits can be anticipated. It may therefore be the time to face the challenge in the non-mental health area and develop similar measurable approaches in other chronic disease areas.

From expectations to experience One of the most difficult issues in measuring quality of living once disease is diagnosed and treatment initiated is people's desire and assumption or hope that treatment will restore them to normality. What is “normal” is one question. The other is whether it is possible to restore life to the routines of pre-diagnosis. At best, experts define the role of healthcare professionals as limited to helping people integrate the disease into their lives rather than subjecting themselves to the tyranny of the illness and/or the treatment.(13) In the pursuit of further accuracy and personalisation of the data, some experts have improved on the WHO-5 by proposing a new model of measurement of quality of living. This more demanding model is based on a comparison between people's expectations of their health state (by implication also of the healthcare system) and their actual experiences of living with disease and treatments.

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This also implies their expectations of the kind of care they receive and the way they and their carers are treated. According to the researchers who have formulated this model (14), there are three important aspects to consider: • People's evaluations of their quality of life are made within horizons of possibilities that they see for themselves and therefore are a fundamental component of their identity. These horizons are determined by factors such as social class, age, sex, ethnic group, sexuality, disability, and personal biography, including their previous experience with disease and with the healthcare system. • The size of the gap between expectations and experiences depends on the timing of the measurement. The disease trajectory and the person's mental state at the time will have a direct influence on both their expectations and experiences. Moreover, responses to illness are highly individual: there is no standardised pattern followed by all patients. Intervening or tracking on a very regular basis is therefore critical for accuracy, enabling the health professional to change the experience and thus modify expectations. • These first two points are closely linked to the third aspect of the model – the fact that experiences will continually change a person’s expectations: people constantly move towards what the researchers call an ever changing point of equilibrium. The mechanisms by which people evaluate or quantify their quality of life change over time and in response to many factors. The result is an inherent instability in its meaning of quality of living. This model has been applied successfully in dentistry say the authors. Might it be possible to see its impact in other parts of the healthcare system, especially in the area of chronic disease which requires a more holistic and consistent approach to treatment than is currently available in the NHS?

Why measure? There appears to be consensus among healthcare professionals, politicians and patient groups that the quality of patients' lives is important not only as an ideology but also as an important consideration in providing treatment and a key outcome of excellent care. There is also a sense that basing policies and treatments on sharable evidence is the right way to improve care and best practice. There is no consensus, however, on how measurements link to the achievement of good quality of living for patients. As a result there is no consensus on what would constitute the right set of measurements that can map the route to this goal. Fundamentally the question is about the nature of measurement and its ability to impact on quality of care and the perceptions of excellence. But true measurements of quality of living are, as indicated, very complex: they are very personal, very particular and very changeable. All of that does not align easily with the philosophy of equality, large-scale reach and consistency which are fundamental principles of the NHS.

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Conclusion: So, why bother? •

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First of all because the commitment to “patient-centred” care cannot be realised unless patients become true active participants in defining the goals, channels, deliverables and outcomes of the health service for which they are paying and to which they are entitled. To achieve such a shift we need the evidence from people themselves, telling policy makers and healthcare professionals, in real time and context, how their lives are or might be affected. True measurements will lead to true insights into human behaviours and communication. These, in turn, can lead to significant improvement in planning and delivery of care, as well as in designing successful prevention campaigns rather than short-lived advertising blitzes. So, measurement can play a pivotal role in providing a more positive and proactive patient reaction to treatment. Measurement will greatly broaden the definition or focus of "quality of life", which will help policy makers and healthcare professionals take a more holistic and more human approach to the interactions with patients and to the decisions on services that are needed. Finally, in a very real sense, we should measure accurately, and generate actionable data, because we can. Taking a chapter from other large-scale systems that delve deeply into people's lives: credit card usage, telephone and mobile communications or even the internet-based electoral recruitment systems, it is today possible to produce a very good picture of the individuals under care. And if, in this way and with the help of technology, people become real prime movers in healthcare, as they do in other consumer services rather than passive recipients of NHS services, then everybody wins – patients, healthcare professionals and the Government’s NHS budget.

What is needed is the willingness to take a risk, a detailed assessment and analysis of the various measurement systems, the use of ample imagination and creativity to apply the models to new areas and the will and belief to try them out. This will be the first step in a new NHS, one that delivers real quality care to many.

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References 1. High Quality Care for All: NHS Next Stage Review Final Report, 30.6.08, Professor the Lord Darzi of Denham, KBE 2. The QALYity Project (2007). What do patients really mean by quality of life? Alexandra Wyke, founder of PatientView 3. Changing Diabetes Barometer Report, Novo Nordisk, December 2008 4. Patient Power – mobilising the patients in a new war on chronic diseases, Erik Rasmussen for Oxford Vision 2020, Summit2004 5. Health Measurement Research Group, www.healthmeasurement.org 6. Measuring Effectiveness and Cost Effectiveness: the QALY, National Institute for Health and Clinical Excellence (NICE), www.nice.org.uk 7. NICE guideline manual 8. Response from the Faculty of Old Age Psychiatry of the Royal College of Psychiatrists to the NICE Appraisal Consultation document: rivastigmine, galantamine and memantine for the treatment of Alzheimer’s disease, 22.03.05 9. NICE, Alzheimer’s and the QALY, Clinical Ethics 2007, volume 2 number 1 10. BUPA calls for compulsory collection of PROMs in all private hospitals, press release, 16.6.08 11. PROMs in Elective Surgery: Report to the Department of Health, London School of Hygiene & Tropical Medicine & Clinical Effectiveness Unit, 12.12.07 12. About NHS patient surveys, Healthcare Commission, www.healthcarecomission.org.uk 13. Diabetes: finding excellence? The MODEL Group 14. Is quality of life determined by expectations or experience? Alison J Carr, BMJ 2001:322:1240-1243 (19 May)